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As of October 1, 2009
Title 42, Part 430 to End
Revised as of October 1, 2008
Is Replaced by
Title 40, Parts 430 to 481
and
Title 42, Part 482 to End
Cite this Code:
The Code of Federal Regulations is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. The Code is divided into 50 titles which represent broad areas subject to Federal regulation. Each title is divided into chapters which usually bear the name of the issuing agency. Each chapter is further subdivided into parts covering specific regulatory areas.
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Title 42—
The OMB control numbers for the Centers for Medicare & Medicaid Services appear in § 400.310 of chapter IV. For the convenience of the user, subpart C consisting of §§ 400.300-400.310 is reprinted in the Finding Aids section of the third, fourth and fifth volumes.
For this volume, Jonn V. Lilyea was Chief Editor. The Code of Federal Regulations publication program is under the direction of Michael L. White, assisted by Ann Worley.
(Parts 430 to 481)
Nomenclature changes to chapter IV appear at 66 FR 39452, July 31, 2001; 67 FR 36540, May 24, 2002; and 69 FR 18803, Apr. 9, 2004.
Sec. 1102 of the Social Security Act (42 U.S.C. 1302).
Title XIX of the Social Security Act, enacted in 1965, authorizes Federal grants to States for medical assistance to low-income persons who are age 65 or over, blind, disabled, or members of families with dependent children or qualified pregnant women or children. The program is jointly financed by the Federal and State governments and administered by States. Within broad Federal rules, each State decides eligible groups, types and range of services, payment levels for services, and administrative and operating procedures. Payments for services are made directly by the State to the individuals or entities that furnish the services.
The regulations in subchapter C set forth State plan requirements, standards, procedures, and conditions for obtaining Federal financial participation (FFP). Each part (or subpart of section) in the subchapter describes the specific statutory basis for the regulation. However, where the basis is the Secretary's general authority to issue regulations for any program under the Act (section 1102 of the Act), or his general authority to prescribe State plan requirements needed for proper and efficient administration of the
Other regulations applicable to State Medicaid programs include the following:
(a) 5 CFR part 900, subpart F, Administration of the Standards for a Merit System of Personnel Administration.
(b) The following HHS Regulations in 45 CFR subtitle A:
Three distinct types of disputes may arise under Medicaid.
(a)
(b)
(c)
As used in this subchapter, unless the context indicates otherwise—
The State plan is a comprehensive written statement submitted by the agency describing the nature and scope of its Medicaid program and giving assurance that it will be administered in conformity with the specific requirements of title XIX, the regulations in this Chapter IV, and other applicable official issuances of the Department. The State plan contains all information necessary for CMS to determine whether the plan can be approved to serve as a basis for Federal financial participation (FFP) in the State program.
(a)
(b)
(i) The Medicaid agency must submit the State plan and State plan amendments to the State Governor or his designee for review and comment before submitting them to the CMS regional office.
(ii) The plan must provide that the Governor will be given a specific period
(iii) Any comments from the Governor must be submitted to CMS with the plan or plan amendment.
(2)
(ii) Governor's review is not required for preprinted plan amendments that are developed by CMS if they provide absolutely no options for the State.
(c)
(i) Changes in Federal law, regulations, policy interpretations, or court decisions; or
(ii) Material changes in State law, organization, or policy, or in the State's operation of the Medicaid program. For changes related to advance directive requirements, amendments must be submitted as soon as possible, but no later than 60 days from the effective date of the change to State law concerning advance directives.
(2) Prompt submittal of amendments is necessary—
(i) So that CMS can determine whether the plan continues to meet the requirements for approval; and
(ii) To ensure the availability of FFP in accordance with § 430.20.
CMS regional staff reviews State plans and plan amendments, discusses any issues with the Medicaid agency, and consults with central office staff on questions regarding application of Federal policy.
(a)
(2) Guidelines are furnished to assist in the interpretation of the regulations.
(b)
(c)
(2) The Administrator does not make a final determination of disapproval without first consulting the Secretary.
(a)
(i) Written notice of disapproval; or
(ii) Written notice of any additional information it needs in order to make a final determination.
(2) If CMS requests additional information, the 90-day period for CMS action on the plan or plan amendment begins on the day it receives that information.
(b)
(2) Only the Administrator gives notice of disapproval of a State plan or plan amendment.
(a)
(b)
(2) The hearing takes place not less than 30 days nor more than 60 days after the date of the notice, unless the State and the Administrator agree in writing on an earlier or later date.
(c)
(d)
(e)
(2) However, if the Administrator determines that his or her original decision was incorrect, CMS pays the State a lump sum equal to any funds incorrectly denied.
For purposes of FFP, the following rules apply:
(a)
(1) May not be earlier than the first day of the quarter in which an approvable plan is submitted to the regional office; and
(2) With respect to expenditures for medical assistance, may not be earlier than the first day on which the plan is in operation on a statewide basis.
(b)
(2) For a plan amendment that changes the State's payment method and standards, the rules of § 447.256 of this chapter apply.
(3) For other plan amendments, the effective date may be a date requested by the State if CMS approves it.
(a)
(b)
(c)
(i) Implement a primary care case-management system or a specialty physician system.
(ii) Designate a locality to act as central broker in assisting Medicaid recipients to choose among competing health care plans.
(iii) Share with recipients (through provision of additional services) cost-savings made possible through the recipients' use of more cost-effective medical care.
(iv) Limit recipients' choice of providers (except in emergency situations and with respect to family planning services) to providers that fully meet reimbursement, quality, and utilization standards, which are established under the State plan and are consistent with access, quality, and efficient and economical furnishing of care.
(2) A waiver under section 1915(c) of the Act allows a State to include as “medical assistance” under its plan home and community based services furnished to recipients who would otherwise need inpatient care that is furnished in a hospital, SNF, ICF, or ICF/
(3) A waiver under section 1916 (a)(3) or (b)(3) of the Act allows a State to impose a deduction, cost-sharing or similar charge of up to twice the “nominal charge” established under the plan for outpatient services, if—
(i) The outpatient services are received in a hospital emergency room but are not emergency services; and
(ii) The State has shown that Medicaid recipients have actually available and accessible to them alternative services of nonemergency outpatient services.
(d)
(1) Under section 1915(b) of the Act, and subject to certain limitations, any of the State plan requirements of section 1902 of the Act may be waived to achieve one of the purposes specified in that section.
(2) Under section 1915(c) of the Act, the following requirements may be waived:
(i) Statewideness—section 1902(a)(1).
(ii) Comparability of services—section 1902(a)(10)(B).
(iii) Income and resource rules—section 1902(a)(10)(C)(i)(III).
(3) Under section 1916 of the Act, paragraphs (a)(3) and (b)(3) require that any cost-sharing imposed on recipients be nominal in amount, and provide an exception for nonemergency services furnished in a hospital emergency room if the conditions of paragraph (c)(3) of this section are met.
(e)
(f)
(2) CMS regional and central office staff review waiver requests and submit a recommendation to the Administrator, who—
(i) Has the authority to approve or deny waiver requests; and
(ii) Does not deny a request without first consulting the Secretary.
(3) A waiver request is considered approved unless, within 90 days after the request is received by CMS, the Administrator denies the request, or the Administrator or the Regional Administrator sends the State a written request for additional information necessary to reach a final decision. If additional information is requested, a new 90-day period begins on the day the response to the additional information request is received by the addressee.
(g)
(2)
(h)
(2)
(ii)
(3)
(ii) If a renewal request for a section 1915(c) waiver proposes a change in services provided, eligible population, service area, or statutory sections
(a)
(2) The amount of the quarterly grant is determined on the basis of information submitted by the State agency (in quarterly estimate and quarterly expenditure reports) and other pertinent documents.
(b)
(c)
(2) This report is the State's accounting of actual recorded expenditures. The disposition of Federal funds may not be reported on the basis of estimates.
(d)
(2)
(i) Penalty reductions imposed by law.
(ii) Accounting adjustments.
(iii) Deferrals or disallowances.
(iv) Interest assessments.
(v) Mandated adjustments such as those required by section 1914 of the Act.
(3)
(4)
(e)
(a)
(b)
(c)
(a)
(1) The program is being operated in a cost-efficient manner; and
(2) Funds are being properly expended for the purposes for which they were appropriated under Federal and State law and regulations.
(b)
(2) The reports set forth OIG opinion and recommendations regarding the practices it reviewed, and the allowability of the costs it audited.
(3) Cognizant officials of the Department make final determinations on all audit findings.
(c)
(2)
(3)
(a)
(1) That the plan no longer complies with the provisions of section 1902 of the Act; or
(2) That in the administration of the plan there is failure to comply substantially with any of those provisions.
(b)
(c)
(d)
(1) The Administrator notifies the State:
(i) That no further payments will be made to the State (or that payments will be made only for those portions or aspects of the program that are not affected by the noncompliance); and
(ii) That the total or partial withholding will continue until the Administrator is satisfied that the State's plan and practice are, and will continue to be, in compliance with Federal requirements.
(2) CMS withholds payments, in whole or in part, until the Administrator is satisfied regarding the State's compliance.
(a)
(b)
(2) The clerk of the court will file a copy of the petition with the Administrator and the Administrator will file in the court the record of the proceedings on which the determination was based.
(c)
(2) The court has jurisdiction to affirm the Administrator's decision, to set it aside in whole or in part, or, for good cause, to remand the case for additional evidence.
(d)
(2) The Administrator will certify to the court the transcript and record of the further proceedings.
(e)
(a)
(1) The Regional Administrator or the Administrator questions its allowability and needs additional information in order to resolve the question; and
(2) CMS takes action to defer the claim (by excluding the claimed amount from the grant award) within 60 days after the receipt of a Quarterly Statement of Expenditures (prepared in accordance with CMS instructions) that includes that claim.
(b)
(i) Identifies the type and amount of the deferred claim and specifies the reason for deferral; and
(ii) Requests the State to make available all the documents and materials the regional office then believes are necessary to determine the allowability of the claim.
(2) It is the responsibility of the State to establish the allowability of a deferred claim.
(c)
(2) Regional office staff usually initiates review within 30 days after receipt of the documents and materials.
(3) If the Regional Administrator finds that the materials are not in readily reviewable form or that additional information is needed, he or she promptly notifies the State that it has 15 days to submit the readily reviewable or additional materials.
(4) If the State does not provide the necessary materials within 15 days, the Regional Administrator disallows the claim.
(5) The Regional Administrator has 90 days, after all documentation is available in readily reviewable form, to determine the allowability of the claim.
(6) If the Regional Administrator cannot complete review of the material within 90 days, CMS pays the claim, subject to a later determination of allowability.
(d)
(e)
(2) If the decision is to disallow, the notice informs the State of its right to reconsideration in accordance with 45 CFR part 16.
(a)
(1) The date or dates on which the State's claim for FFP was made.
(2) The time period during which the expenditures in question were made or claimed to have been made.
(3) The date and amount of any payment or notice of deferral.
(4) A statement of the amount of FFP claimed, allowed, and disallowed and the manner in which these amounts were computed.
(5) Findings of fact on which the disallowance determination is based or a reference to other documents previously furnished to the State or included with the notice (such as a report of a financial review or audit) which contain the findings of fact on which the disallowance determination is based.
(6) Pertinent citations to the law, regulations, guides and instructions supporting the action taken.
(7) A request that the State make appropriate adjustment in a subsequent expenditure report.
(8) Notice of the State's right to request reconsideration of the disallowance and the time allowed to make the request.
(9) A statement indicating that the disallowance letter is the Department's final decision unless the State requests reconsideration under paragraph (b)(2) of this section.
(b)
(2) A State that wishes to request reconsideration must submit the request to the Chair, Departmental Appeals Board, within 30 days after receipt of the disallowance letter, and include—
(i) A copy of the disallowance letter;
(ii) A statement of the amount in dispute; and
(iii) A brief statement of why the disallowance is wrong.
(c)
(d)
(a)
(1) The Federal Medical Assistance Percentage;
(2) The amount of State expenditures subject to FFP;
(3) The rates of FFP; or
(4) The amount otherwise payable to the State.
(b)
(c)
(a)
(1) The amount to be repaid exceeds 2
(2) The State has given the Regional Administrator written notice, before total repayment was due, of its intent to repay by installments.
(b)
(1) If the Medicaid program is ongoing, CMS uses the annual
(2) If the Medicaid program has been terminated by Federal law or by the State, CMS uses the
(c)
(2)
(3)
(4)
(5)
(6)
(i) Suspend payments until the retroactive claim due the State has, in fact, been offset; or
(ii) Continue payments until the reduced amount of its debt (remaining after the offset), has been paid in full.
(a) This subpart sets forth the rules for hearings to States that appeal a decision to disapprove State plan material (under § 430.18) or to withhold Federal funds (under § 430.35), because the
(b) Nothing in this subpart is intended to preclude or limit negotiations between CMS and the State, whether before, during, or after the hearing to resolve the issues that are, or otherwise would be, considered at the hearing. Such negotiations and resolution of issues are not part of the hearing, and are not governed by the rules in this subpart except as expressly provided.
All pleadings, correspondence, exhibits, transcripts of testimony, exceptions, briefs, decisions, and other documents filed in the docket in any proceeding may be inspected and copied in the office of the CMS Docket Clerk. Inquiries may be made to the Docket Clerk, Hearing Staff, Bureau of Eligibility, Reimbursment and Coverage, 300 East High Rise, 6325 Security Boulevard, Baltimore, Maryland, 21207. Telephone: (301) 594-8261.
(a)
(b)
Upon notice to all parties, the Administrator or the presiding officer may modify or waive any rule in this subpart upon determination that no party will be unduly prejudiced and the ends of justice will thereby be served.
(a) The presiding officer at a hearing is the Administrator or his designee.
(b) The designation of the presiding officer is in writing. A copy of the designation is served on all parties.
The Administrator mails the State a notice of hearing or opportunity for hearing that—
(a) Specifies the time and place for the hearing;
(b) Specifies the issues that will be considered;
(c) Identifies the presiding officer; and
(d) Is published in the
(a)
(b)
The list of issues specified in the notice of hearing may be augmented or reduced as provided in this section.
(a)
(2) If the notice of additional issues is furnished to the State less than 20 days before the scheduled hearing date, postponement is granted if requested by the State or any other party. The new date may be 20 days after the date of the notice, or a later date agreed to by the presiding officer.
(b)
(c)
(2)
(i) A statement of the intent to remove and the reasons for removal; and
(ii) A copy of the proposed State plan provision on which CMS and the State have agreed.
(3)
(d)
(a)
(b)
(2)
(i) Petitioner's interest in the proceeding;
(ii) Who will appear for petitioner;
(iii) The issues on which petitioner wishes to participate; and
(iv) Whether petitioner intends to present witnesses.
(3)
(4)
(ii) If petitions are made by more than one individual or group with common interests, the presiding officer may—
(A) Request all those petitioners to designate a single representative; or
(B) Recognize one or more of those petitioners to represent all of them.
(iii) The presiding officer gives each petitioner written notice of the decision and, if the decision is to deny, briefly states the grounds for denial.
(c)
(i) The petitioners' interest in the hearing;
(ii) Who will represent the petitioner; and
(iii) The issues on which the petitioner intends to present argument.
(2)
(3)
(i) Submitting a written statement of position to the presiding officer before the beginning of the hearing;
(ii) Presenting a brief oral statement at the hearing, at the point in the proceedings specified by the presiding officer; and
(iii) Submitting a brief or written statement when the parties submit briefs.
(a) The presiding officer has the duty to conduct a fair hearing, to avoid delay, maintain order, and make a record of the proceedings. He or she has the authority necessary to accomplish those ends, including but not limited to authority to take the following actions:
(1) Change the date, time, and place of the hearing after due notice to the parties. This includes authority to postpone or adjourn the hearing in whole or in part. In a hearing on disapproval of a State plan, or State plan amendments, changes in the date of the hearing are subject to the time limits imposed by section 1116(a)(2) of the Act.
(2) Hold conferences to settle or simplify the issues, or to consider other matters that may aid in the expeditious disposition of the issues.
(3) Regulate participation of parties and amici curiae and require parties and amici curiae to state their position with respect to the various issues in the proceeding.
(4) Administer oaths and affirmations.
(5) Rule on motions and other procedural items, including issuance of protective orders or other relief to a party against whom discovery is sought.
(6) Regulate the course of the hearing and conduct of counsel.
(7) Examine witnesses.
(8) Receive, rule on, exclude or limit evidence or discovery.
(9) Fix the time for filing motions, petitions, briefs, or other items.
(10) If the presiding officer is the Administrator, make a final decision.
(11) If the presiding officer is a designee of the Administrator, certify the entire record including recommended findings and proposed decision to the Administrator.
(12) Take any action authorized by the rules in this subpart or in conformance with the provisions of 5 U.S.C. 551 through 559.
(b) The presiding officer does not have authority to compel by subpoena the production of witnesses, papers, or other evidence.
(c) If the presiding officer is a designee of the Administrator, his or her authority pertains to the issues of compliance by a State with Federal requirements, and does not extend to the question of whether, in case of any noncompliance, Federal payments will be denied in respect to the entire State plan or only for certain categories under, or parts of, the State plan affected by the noncompliance.
All parties may:
(a) Appear by counsel or other authorized representative, in all hearing proceedings.
(b) Participate in any prehearing conference held by the presiding officer.
(c) Agree to stipulations as to facts which will be made a part of the record.
(d) Make opening statements at the hearing.
(e) Present relevant evidence on the issues at the hearing.
(f) Present witnesses who then must be available for cross-examination by all other parties.
(g) Present oral arguments at the hearing.
(h) Submit written briefs, proposed findings of fact, and proposed conclusions of law, after the hearing.
CMS and any party named in the notice issued under § 430.70 has the right to conduct discovery (including depositions) against opposing parties. Rules 26-37 of the Federal Rules of Civil Procedures apply to such proceedings; there will be no fixed rule on priority of discovery. Upon written motion, the presiding officer promptly rules upon any objection to discovery action initiated under this section. The presiding officer also has the power to grant a
(a)
(b)
(c)
(d)
(2) A witness may be cross-examined on any matter material to the proceeding without regard to the scope of his or her direct examination.
(3) The presiding officer may exclude irrelevant, immaterial, or unduly repetitious evidence.
(4) All documents and other evidence offered or taken for the record are open to examination by the parties and an opportunity is given to refute facts and arguments advanced on either side of the issues.
The presiding officer may immediately exclude from the hearing any person who—
(a) Uses disrespectful, disorderly, or contumacious language or engages in contemptuous behavior;
(b) Refuses to comply with directions; or
(c) Uses dilatory tactics.
Letters expressing views or urging action and other unsponsored written material regarding matters in issue in a hearing are placed in the correspondence section of the docket of the proceeding. These data are not considered part of the evidence or record in the hearing.
(a)
(b)
(c)
The transcript of testimony, exhibits, and all papers and requests filed in the proceedings, except the correspondence section of the docket, including rulings and any recommended or initial decision constitute the exclusive record for decision.
The presiding officer fixes the time for filing posthearing briefs, which may contain proposed findings of fact and conclusions of law. The presiding officer may also permit reply briefs.
(a)
(b)
(1) Upon expiration of the period allowed for submission of posthearing briefs, the presiding officer certifies the entire record, including his or her recommended findings and proposed decision, to the Administrator. The Administrator serves a copy of the recommended findings and proposed decision upon all parties and amici, if any.
(2) Any party may, within 20 days, file with the Administrator exceptions to the recommended findings and proposed decision and a supporting brief or statement.
(3) The Administrator reviews the recommended decision and, within 60 days of its issuance, issues his or her own decision.
(c)
(a)
(1) Whether no further payments will be made to the State or whether payments will be limited to parts of the program not affected by the noncompliance; and
(2) The effective date of the decision to withhold.
(b)
(c)
Sec. 1102 of the Social Security Act, (42 U.S.C. 1302).
This part establishes State plan requirements for the designation, organization, and general administrative activities of a State agency responsible for operating the State Medicaid program, directly or through supervision of local administering agencies.
(a)
(b)
(1) Specify a single State agency established or designated to administer or supervise the administration of the plan; and
(2) Include a certification by the State Attorney General, citing the legal authority for the single State agency to—
(i) Administer or supervise the administration of the plan; and
(ii) Make rules and regulations that it follows in administering the plan or that are binding upon local agencies that administer the plan.
(c)
(i) The Medicaid agency; or
(ii) The single State agency for the financial assistance program under title IV-A (in the 50 States or the District of Columbia), or under title I or XVI (AABD), in Guam, Puerto Rico, or the Virgin Islands.
(2) The plan must specify whether the agency that determines eligibility for the aged, blind, or disabled is—
(i) The Medicaid agency;
(ii) The single State agency for the financial assistance program under title IV-A (in the 50 States or the District of Columbia) or under title I or XVI (AABD), in Guam, Puerto Rico, or the Virgin Islands; or
(iii) The Federal agency administering the supplemental security income program under title XVI (SSI). In this case, the plan must also specify whether the Medicaid agency or the title IV-A agency determines eligibility for any groups whose eligibility is not determined by the Federal agency.
(d)
(e)
(1) The agency must not delegate, to other than its own officials, authority to—
(i) Exercise administrative discretion in the administration or supervision of the plan, or
(ii) Issue policies, rules, and regulations on program matters.
(2) The authority of the agency must not be impaired if any of its rules, regulations, or decisions are subject to review, clearance, or similar action by other offices or agencies of the State.
(3) If other State or local agencies or offices perform services for the Medicaid agency, they must not have the authority to change or disapprove any administrative decision of that agency, or otherwise substitute their judgment for that of the Medicaid agency with respect to the application of policies, rules, and regulations issued by the Medicaid agency.
(a)
(b)
(c)
(i) A description of the organization and functions of the Medicaid agency and an organization chart;
(ii) A description of the organization and functions of the medical assistance unit and an organization chart; and
(iii) A description of the kinds and number of professional medical personnel and supporting staff used in the administration of the plan and their responsibilities.
(d)
(a)
(b)
(c)
(d)
(1) Board-certified physicians and other representatives of the health professions who are familiar with the medical needs of low-income population groups and with the resources available and required for their care;
(2) Members of consumers' groups, including Medicaid recipients, and consumer organizations such as labor unions, cooperatives, consumer-sponsored prepaid group practice plans, and others; and
(3) The director of the public welfare department or the public health department, whichever does not head the Medicaid agency.
(e)
(f)
(1) Staff assistance from the agency and independent technical assistance as needed to enable it to make effective recommendations; and
(2) Financial arrangements, if necessary, to make possible the participation of recipient members.
(g)
A State plan must provide for methods of administration that are found by the Secretary to be necessary for the proper and efficient operation of the plan.
A State plan must provide that the Medicaid agency will—
(a) Submit all reports required by the Secretary;
(b) Follow the Secretary's instructions with regard to the form and content of those reports; and
(c) Comply with any provisions that the Secretary finds necessary to verify and assure the correctness of the reports.
(a)
(b)
(1) Individual records on each applicant and recipient that contain information on—
(i) Date of application;
(ii) Date of and basis for disposition;
(iii) Facts essential to determination of initial and continuing eligibility;
(iv) Provision of medical assistance;
(v) Basis for discontinuing assistance;
(vi) The disposition of income and eligibility verification information received under §§ 435.940 through 435.960 of this subchapter; and
(2) Statistical, fiscal, and other records necessary for reporting and accountability as required by the Secretary.
(c)
(d)
(1) The agency must make a study of its record storage and must show that the use of microfilm is efficient and economical.
(2) The microfilm system must not hinder the agency's supervision and control of the Medicaid program.
(3) The microfilm system must—
(i) Enable the State to audit the propriety of expenditures for which FFP is claimed; and
(ii) Enable the HHS Audit Agency and CMS to properly discharge their respective responsibilities for reviewing the manner in which the Medicaid program is being administered.
(4) The agency must obtain approval from the CMS regional office indicating—
(i) The system meets the conditions of paragraphs (d)(2) and (3) of this section; and
(ii) The microfilming procedures are reliable and are supported by an adequate retrieval system.
(a)
(b)
(c)
(2) These documents must be available upon request for review, study, and reproduction by individuals during regular working hours of the agency.
(d)
(1) Public and university libraries;
(2) The local or district offices of the Bureau of Indian Affairs;
(3) Welfare and legal services offices; and
(4) Other entities that—
(i) Request the material in order to make it accessible to the public;
(ii) Are centrally located and accessible to a substantial number of the recipient population they serve; and
(iii) Agree to accept responsibility for filing all amendments or changes forwarded by the agency.
(e)
(1) To determine whether to request a fair hearing; or
(2) To prepare for a fair hearing.
(f)
(g)
(a)
(b) A State Plan must provide that the State, acting through a State agency, association, or other private nonprofit entity, develop a written description of the State law (whether statutory or as recognized by the courts of the State) concerning advance directives, as defined in § 489.100 of this chapter, to be distributed by Medicaid providers and health maintenance organizations (as specified in section 1903(m)(1)(A) of the Act) in accordance with the requirements under part 489, subpart I of this chapter. Revisions to the written descriptions as a result of changes in State law must be incorporated in such descriptions and distributed as soon as possible, but no later than 60 days from the effective date of the change in State law, to Medicaid providers and health maintenance organizations.
(a) This subpart sets forth State plan requirements and exceptions that pertain to the following administrative requirements and provisions of the Act:
(1) Statewideness—section 1902(a)(1);
(2) Proper and efficient administration—section 1902(a)(4);
(3) Comparability of services—section 1902(a)(10) (B)-(E);
(4) Payment for services furnished outside the State—section 1902(a)(16);
(5) Free choice of providers—section 1902(a)(23);
(6) Special waiver provisions applicable to American Samoa and the Northern Mariana Islands—section 1902(j); and
(7) Exceptions to, and waiver of, State plan requirements—sections 1915 (a)-(c) and 1916 (a)(3) and (b)(3).
(b) Other applicable regulations include the following:
(1) Section 430.25Waivers of State plan requirements.
(2) Section 440.250Limits on comparability of services.
(a)
(b)
(1) The plan will be in operation statewide through a system of local offices, under equitable standards for assistance and administration that are mandatory throughout the State.
(2) If administered by political subdivisions of the State, the plan will be mandatory on those subdivisions.
(3) The agency will ensure that the plan is continuously in operation in all local offices or agencies through—
(i) Methods for informing staff of State policies, standards, procedures, and instructions;
(ii) Systematic planned examination and evaluation of operations in local offices by regularly assigned State staff who make regular visits; and
(iii) Reports, controls, or other methods.
(c)
(2) Other allowable exceptions and waivers are set forth in §§ 431.54 and 431.55.
(a)
(1) Section 1902(a)(23) of the Act provides that recipients may obtain services from any qualified Medicaid provider that undertakes to provide the services to them.
(2) Section 1915(a) of the Act provides that a State shall not be found out of compliance with section 1902(a)(23) solely because it imposes certain specified allowable restrictions on freedom of choice.
(3) Section 1915(b) of the Act authorizes waiver of the section 1902(a)(23) freedom of choice of providers requirement in certain specified circumstances, but not with respect to providers of family planning services.
(4) Section 1902(a)(23) of the Act provides that a recipient enrolled in a primary care case management system or Medicaid managed care organization (MCO) may not be denied freedom of choice of qualified providers of family planning services.
(5) Section 1902(e)(2) of the Act provides that an enrollee who, while completing a minimum enrollment period, is deemed eligible only for services furnished by or through the MCO or PCCM, may, as an exception to the deemed limitation, seek family planning services from any qualified provider.
(6) Section 1932(a) of the Act permits a State to restrict the freedom of choice required by section 1902(a)(23), under specified circumstances, for all services except family planning services.
(b)
(1) Except as provided under paragraph (c) of this section and part 438 of this chapter, a recipient may obtain Medicaid services from any institution, agency, pharmacy, person, or organization that is—
(i) Qualified to furnish the services; and
(ii) Willing to furnish them to that particular recipient.
(2) A recipient enrolled in a primary care case-management system, a Medicaid MCO, or other similar entity will not be restricted in freedom of choice of providers of family planning services.
(c)
(1) Establishing the fees it will pay providers for Medicaid services;
(2) Setting reasonable standards relating to the qualifications of providers; or
(3) Subject to paragraph (b)(2) of this section, restricting recipients' free choice of providers in accordance with one or more of the exceptions set forth in § 431.54, or under a waiver as provided in § 431.55; or
(4) Limiting the providers who are available to furnish targeted case management services defined in § 440.169 of this chapter to target groups that consist solely of individuals with developmental disabilities or with chronic mental illness. This limitation may only be permitted so that the providers of case management services for eligible individuals with developmental disabilities or with chronic mental illness are capable of ensuring that those individuals receive needed services.
(d)
(2)
(ii) For exceptions under § 431.54 (e) or (f), the State must submit the certificate by the end of the quarter in which it implements the project.
(a)
(b)
(1) Medical services are needed because of a medical emergency;
(2) Medical services are needed and the recipient's health would be endangered if he were required to travel to his State of residence;
(3) The State determines, on the basis of medical advice, that the needed medical services, or necessary supplementary resources, are more readily available in the other State;
(4) It is general practice for recipients in a particular locality to use medical resources in another State.
(c)
A State plan must—
(a) Specify that the Medicaid agency will ensure necessary transportation for recipients to and from providers; and
(b) Describe the methods that the agency will use to meet this requirement.
(a)
(2) Section 1915(g) of the Act provides that a State may provide, as medical assistance, targeted case management services under the plan without regard to the requirements of sections 1902(a)(1) and 1902(a)(10)(B) of the Act.
(b)
(c) [Reserved]
(d)
(1) Adequate services or devices are available to recipients under the special procedures.
(2) Laboratory services are furnished through laboratories that meet the following requirements:
(i) They are independent laboratories, or inpatient or outpatient hospital laboratories that provide services for individuals who are not hospital patients, or physician laboratories that process at least 100 specimens for other physicians during any calendar year.
(ii) They meet the requirements of subpart M of part 405 or part 482 of this chapter.
(iii) Laboratories that require an interstate license under 42 CFR part 74 are licensed by CMS or receive an exemption from the licensing requirement by the College of American Pathologists. (Hospital and physician laboratories may participate in competitive bidding only with regard to services to non-hospital patients and other physicians' patients, respectively.)
(3) Any laboratory from which a State purchases services under this section has no more than 75 percent of its charges based on services to Medicare beneficiaries and Medicaid recipients.
(e)
(1) The agency gives the recipient notice and opportunity for a hearing (in accordance with procedures established by the agency) before imposing the restrictions.
(2) The agency ensures that the recipient has reasonable access (taking into account geographic location and reasonable travel time) to Medicaid services of adequate quality.
(3) The restrictions do not apply to emergency services furnished to the recipient.
(f)
Before imposing any restriction, the agency must meet the following conditions:
(1) Give the provider notice and opportunity for a hearing, in accordance with procedures established by the agency.
(2) Find that in a significant number or proportion of cases, the provider has:
(i) Furnished Medicaid services at a frequency or amount not medically necessary, as determined in accordance with utilization guidelines established by the agency; or
(ii) Furnished Medicaid services of a quality that does not meet professionally recognized standards of health care.
(3) Notify CMS and the general public of the restriction and its duration.
(4) Ensure that the restrictions do not result in denying recipients reasonable access (taking into account geographic location: and reasonable travel time) to Medicaid services of adequate quality, including emergency services.
(g)
(a)
(b)
(2) In applying for a waiver to implement an approvable project under paragraph (c), (d), (e), or (f) of this section, a Medicaid agency must document in the waiver request and maintain data regarding:
(i) The cost-effectiveness of the project;
(ii) The effect of the project on the accessibility and quality of services;
(iii) The anticipated impact of the project on the State's Medicaid program and;
(iv) Assurances that the restrictions on free choice of providers do not apply to family planning services.
(3) No waiver under this section may be granted for a period longer than 2 years, unless the agency requests a continuation of the waiver.
(4) CMS monitors the implementation of waivers granted under this section to ensure that requirements for such waivers are being met.
(i) If monitoring demonstrates that the agency is not in compliance with the requirements for a waiver under this section, CMS gives the agency notice and opportunity for a hearing.
(ii) If, after a hearing, CMS finds an agency to be out of compliance with the requirements of a waiver, CMS terminates the waiver and gives the agency a specified date by which it must demonstrate that it meets the applicable requirements of section 1902 of the Act.
(5) The requirements of section 1902(s) of the Act, with regard to adjustments in payments for inpatient hospital services furnished to infants who have not attained age 1 and to children who have not attained age 6 and who receive these services in disproportionate share hospitals, may not be waived under a section 1915(b) waiver.
(c)
(i) Under a primary care case-management system the agency assures that a specific person or persons or agency will be responsible for locating, coordinating, and monitoring all primary care or primary care and other medical care and rehabilitative services on behalf of a recipient. The person or agency must comply with the requirements set forth in part 438 of this chapter for primary care case management contracts and systems.
(ii) A specialty physician services system allows States to restrict recipients of specialty services to designated providers of such services, even in the absence of a primary care case-management system.
(2) A waiver under this paragraph (c) may not be approved unless the State's request assures that the restrictions—
(i) Do not apply in emergency situations; and
(ii) Do not substantially impair access to medically necessary services of adequate quality.
(d)
(1) A locality is any defined jurisdiction, e.g., district, town, city, borough, county, parish, or State.
(2) A locality may use any agency or agent, public or private, profit or nonprofit, to act on its behalf in carrying out its central broker function.
(e)
(2) Sharing is through the provision of additional services, including—
(i) Services furnished by a plan selected by the recipient; and
(ii) Services expressly offered by the State as an inducement for recipients to participate in a primary care case-management system, a competing health care plan or other system that furnishes health care services in a more cost-effective manner.
(f)
(2) An agency may qualify for a waiver under this paragraph (f) only if its applicable State standards are consistent with access, quality and efficient and economic provision of covered care and services and the restrictions it imposes—
(i) Do not apply to recipients residing at a long-term care facility when a restriction is imposed unless the State arranges for reasonable and adequate recipient transfer.
(ii) Do not discriminate among classes of providers on grounds unrelated to their demonstrated effectiveness and efficiency in providing those services; and
(iii) Do not apply in emergency circumstances.
(3) Demonstrated effectiveness and efficiency refers to reducing costs or slowing the rate of cost increase and maximizing outputs or outcomes per unit of cost.
(4) The agency must make payments to providers furnishing services under a freedom of choice waiver under this paragraph (f) in accordance with the timely claims payment standards specified in § 447.45 of this chapter for health care practitioners participating in the Medicaid program.
(g) [Reserved]
(h)
(ii) FFP is available in payments to an entity that furnishes services under a section 1915(b)(1) waiver only if the agency excludes from participation any entity described in paragraph (h)(2) of this section.
(2) Entities that must be excluded. The agency must exclude an entity that meets any of the following conditions:
(i) Could be excluded under section 1128(b)(8) of the Act as being controlled by a sanctioned individual.
(ii) Has a substantial contractual relationship (direct or indirect) with an individual convicted of certain crimes, as described in section 1128(b)(8)(B) of the Act.
(iii) Employs or contracts directly or indirectly with one of the following:
(A) Any individual or entity that, under section 1128 or section 1128A of the Act, is precluded from furnishing health care, utilization review, medical social services, or administrative services.
(B) Any entity described in paragraph (h)(2)(i) of this section.
(3) Definitions. As used in this section, substantial contractual relationship means any contractual relationship that provides for one or more of the following services:
(i) The administration, management, or provision of medical services.
(ii) The establishment of policies, or the provision of operational support, for the administration, management, or provision of medical services.
(a)
(b)
(1) The Federal medical assistance percentage specified in section 1903 of the Act and § 433.10(b) of this chapter.
(2) The limit imposed by section 1108(c) of the Act on the amount of Federal funds payable to American Samoa or the Northern Mariana Islands for care and services that meet the section 1905(a) definition for Medicaid assistance.
(3) The requirement that payment be made only with respect to expenditure made by American Samoa or the Northern Mariana Islands for care and services that meet the section 1905(a) definition of medical assistance.
(a) Sections 1916(a)(3) and 1916(b)(3) of the Act specify the circumstances under which the Secretary is authorized to waive the requirement that cost-sharing amounts be nominal.
(b) For nonemergency services furnished in a hospital emergency room, the Secretary may by waiver permit a State to impose a copayment of up to double the “nominal” copayment amounts determined under § 447.54(a)(3) of this subchapter.
(c) Nonemergency services are services that do not meet the definition of emergency services at § 447.53(b)(4) of this subchapter.
(d) In order for a waiver to be approved under this section, the State must establish to the satisfaction of CMS that alternative sources of nonemergency, outpatient services are available and accessible to recipients.
(e) Although, in accordance with § 431.55(b)(3) of this part, a waiver will generally be granted for a 2-year duration, CMS will reevaluate waivers approved under this section if the State increases the nominal copayment amounts in effect when the waiver was approved.
(f) A waiver approved under this section cannot apply to services furnished before the waiver was granted.
(a)
(b)
(1) Qualify for payments under the maternal and child health and crippled children's program (title V of the Act), Medicaid or Medicare;
(2) Establish and maintain fiscal records necessary for the proper and efficient administration of the Act; and
(3) Provide information needed to determine payments due under the Act for services furnished to recipients.
(c)
(a)
(b)
(1) Keep any records necessary to disclose the extent of services the provider furnishes to recipients;
(2) On request, furnish to the Medicaid agency, the Secretary, or the State Medicaid fraud control unit (if such a unit has been approved by the Secretary under § 455.300 of this chapter), any information maintained under paragraph (b)(1) of this section and any information regarding payments claimed by the provider for furnishing services under the plan;
(3) Comply with the disclosure requirements specified in part 455, subpart B of this chapter; and
(4) Comply with the advance directives requirements for hospitals, nursing facilities, providers of home health care and personal care services, hospices, and HMOs specified in part 489, subpart I, and § 417.436(d) of this chapter.
(a)
(i) Are subject to survey and certification by CMS or the State survey agency; or
(ii) Are deemed to meet Federal requirements on the basis of accreditation by an accrediting organization whose program has CMS approval at the time of accreditation survey and accreditation decision.
(2)
(b)
(1) All applicable Federal requirements as set forth in this chapter; and
(2) Any other requirements imposed by the State for participation in the Medicaid program. (If the provider has a time-limited agreement, the new agreement is effective on the day following expiration of the current agreement.)
(c)
(1) An NF provider agreement is effective on the date on which—
(i) The NF is found to be in substantial compliance as defined in § 488.301 of this chapter; and
(ii) CMS or the State survey agency receives from the NF, if applicable, an approvable waiver request.
(2) For an agreement with any other provider, the effective date is the earlier of the following:
(i) The date on which the provider meets all requirements.
(ii) The date on which a provider is found to meet all conditions of participation but has lower level deficiencies, and CMS or the State survey agency receives from the provider an acceptable plan of correction for the lower level deficiencies, or an approvable waiver request, or both. (The date of receipt is the effective date of the agreement, regardless of when CMS approves the plan of correction or waiver request, or both.)
(d)
(i)
(ii)
(2)
(a)
(b)
(a)
(1) Section 1902(a)(36) of the Act, which requires a State plan to provide that the State survey agency will make publicly available the findings from surveys of health care facilities, laboratories, agencies, clinics, or organizations; and
(2) Section 1106(d) of the Act, which places certain restrictions on the Medicaid agency's disclosure of contractor and provider evaluations.
(b)
(c)
(d)
(e)
(1) Survey reports, except for Joint Commission on the Accreditation of Hospitals reports prohibited from disclosure under § 422.426(b)(2) of this chapter;
(2) Official notifications of findings based on survey reports:
(3) Pertinent parts of written documents furnished by the health care provider to the survey agency that relate to the reports and findings; and
(4) Ownership and contract information as specified in § 455.104 of this subchapter.
(f)
(1) Make statements of deficiencies based on the survey reports available for inspection and copying in both the public assistance office and the Social Security Administration district office serving the area where the provider is located; and
(2) Submit to the Regional Medicaid Director, through the Medicaid agency,
(g)
(1) Retain in the survey agency office and make available upon request survey reports and current and accurate ownership information; and
(2) Make available survey reports, findings, and deficiency statements immediately upon determining that a health care provider is eligible to begin or continue participation in the Medicaid program, or within 90 days after completion of the survey, whichever occurs first.
(h)
(i) Individual contractor performance reviews and other formal performance evaluations of carriers, intermediaries, and State agencies, including the reports of followup reviews;
(ii) Comparative performance evaluations of those contractors, including comparisons of either overall performance or of any particular aspect of contractor operations; and
(iii) Program validation survey reports and other formal performance evaluations of providers, including the reports of followup reviews.
(2) The agency must not make the reports public until—
(i) The contractor or provider has had a reasonable opportunity, not to exceed 30 days, to comment on them; and
(ii) Those comments have been incorporated in the report.
(3) The agency must ensure that the reports contain no identification of individual patients, individual health care practitioners or other individuals.
(a)
(1) Provide that the requirements of subpart D of part 483 of this chapter are met; and
(2) Specify the procedures and rules that the State follows in carrying out the specified requirements, including review and approval of State-operated programs.
(3) To an NF or ICF/MR that is dissatisfied with a determination as to the effective date of its provider agreement.
(b)
(1) Nurse aide training and competency programs, and evaluation of nurse aide competency (1919(e)(1) of the Act).
(2) Nurse aide registry (1919(e)(2) of the Act).
(a)
(1) To a nursing facility (NF) that is dissatisfied with a State's finding of noncompliance that has resulted in one of the following adverse actions:
(i) Denial or termination of its provider agreement.
(ii) Imposition of a civil money penalty or other alternative remedy.
(2) To an intermediate care facility for the mentally retarded (ICF/MR) that is dissatisfied with a State's finding of noncompliance that has resulted in the denial, termination, or nonrenewal of its provider agreement.
(3) To an NF or ICF/MR that is dissatisfied with a determination as to
(b)
The State plan must provide for appeals procedures that, as a minimum, satisfy the requirements of §§ 431.153 and 431.154.
(a)
(b)
(1) The choice of sanction or remedy.
(2) The State monitoring remedy.
(3) [Reserved]
(4) The level of noncompliance found by a State except when a favorable final administrative review decision would affect the range of civil money penalty amounts the State could collect.
(5) A State survey agency's decision as to when to conduct an initial survey of a prospective provider.
(c)
(1) The basis for the decision; and
(2) A statement of the deficiencies on which the decision was based.
(d)
(e)
(i) The evidentiary hearing must be completed either before, or within 120 days after, the effective date of the adverse action; and
(ii) If the hearing is made available only after the effective date of the action, the State must, before that date, offer the ICF/MR an informal reconsideration that meets the requirements of § 431.154.
(2)
(f)
(1)
(2)
(g)
(1) The appeals procedures specified for Medicare facilities in part 498 of this chapter apply; and
(2) A final decision entered under the Medicare appeals procedures is binding for both programs.
(h)
(i)
(1) Opportunity for the facility—
(i) To appear before an impartial decision-maker to refute the finding of noncompliance on which the adverse action was based;
(ii) To be represented by counsel or other representative; and
(iii) To be heard directly or through its representative, to call witnesses, and to present documentary evidence.
(2) A written decision by the impartial decision-maker, setting forth the reasons for the decision and the evidence on which the decision is based.
(j)
(1) The State's finding as to a NF's level of noncompliance must be upheld unless it is clearly erroneous; and
(2) The scope of review is as set forth in § 488.438(e) of this chapter.
The informal reconsideration must, at a minimum, include—
(a) Written notice to the facility of the denial, termination or nonrenewal and the findings upon which it was based;
(b) A reasonable opportunity for the facility to refute those findings in writing, and
(c) A written affirmation or reversal of the denial, termination, or nonrenewal.
This subpart—
(a) Implements section 1902(a)(3) of the Act, which requires that a State plan provide an opportunity for a fair hearing to any person whose claim for assistance is denied or not acted upon promptly;
(b) Prescribes procedures for an opportunity for a hearing if the State agency or PAHP takes action, as stated in this subpart, to suspend, terminate, or reduce services, or an MCO or PIHP takes action under subpart F of part 438 of this chapter; and
(c) Implements sections 1919(f)(3) and 1919(e)(7)(F) of the Act by providing an appeals process for any person who—
(1) Is subject to a proposed transfer or discharge from a nursing facility; or
(2) Is adversely affected by the pre-admission screening or the annual resident review that are required by section 1919(e)(7) of the Act.
For purposes of this subpart:
A State plan must provide that the requirements of §§ 431.205 through 431.246 of this subpart are met.
(a) The Medicaid agency must be responsible for maintaining a hearing system that meets the requirements of this subpart.
(b) The State's hearing system must provide for—
(1) A hearing before the agency; or
(2) An evidentiary hearing at the local level, with a right of appeal to a State agency hearing.
(c) The agency may offer local hearings in some political subdivisions and not in others.
(d) The hearing system must meet the due process standards set forth in
(a) The agency must issue and publicize its hearing procedures.
(b) The agency must, at the time specified in paragraph (c) of this section, inform every applicant or recipient in writing—
(1) Of his right to a hearing;
(2) Of the method by which he may obtain a hearing; and
(3) That he may represent himself or use legal counsel, a relative, a friend, or other spokesman.
(c) The agency must provide the information required in paragraph (b) of this section—(1) At the time that the individual applies for Medicaid;
(2) At the time of any action affecting his or her claim;
(3) At the time a skilled nursing facility or a nursing facility notifies a resident in accordance with § 483.12 of this chapter that he or she is to be transferred or discharged; and
(4) At the time an individual receives an adverse determination by the State with regard to the preadmission screening and annual resident review requirements of section 1919(e)(7) of the Act.
A notice required under § 431.206 (c)(2), (c)(3), or (c)(4) of this subpart must contain—
(a) A statement of what action the State, skilled nursing facility, or nursing facility intends to take;
(b) The reasons for the intended action;
(c) The specific regulations that support, or the change in Federal or State law that requires, the action;
(d) An explanation of—
(1) The individual's right to request an evidentiary hearing if one is available, or a State agency hearing; or
(2) In cases of an action based on a change in law, the circumstances under which a hearing will be granted; and
(e) An explanation of the circumstances under which Medicaid is continued if a hearing is requested.
The State or local agency must mail a notice at least 10 days before the date of action, except as permitted under §§ 431.213 and 431.214 of this subpart.
The agency may mail a notice not later than the date of action if—
(a) The agency has factual information confirming the death of a recipient;
(b) The agency receives a clear written statement signed by a recipient that—
(1) He no longer wishes services; or
(2) Gives information that requires termination or reduction of services and indicates that he understands that this must be the result of supplying that information;
(c) The recipient has been admitted to an institution where he is ineligible under the plan for further services;
(d) The recipient's whereabouts are unknown and the post office returns agency mail directed to him indicating no forwarding address (See § 431.231 (d) of this subpart for procedure if the recipient's whereabouts become known);
(e) The agency establishes the fact that the recipient has been accepted for Medicaid services by another local jurisdiction, State, territory, or commonwealth;
(f) A change in the level of medical care is prescribed by the recipient's physician;
(g) The notice involves an adverse determination made with regard to the preadmission screening requirements of section 1919(e)(7) of the Act; or
(h) The date of action will occur in less than 10 days, in accordance with § 483.12(a)(5)(ii), which provides exceptions to the 30 days notice requirements of § 483.12(a)(5)(i).
The agency may shorten the period of advance notice to 5 days before the date of action if—
(a) The agency has facts indicating that action should be taken because of probable fraud by the recipient; and
(b) The facts have been verified, if possible, through secondary sources.
(a) The State agency must grant an opportunity for a hearing to the following:
(1) Any applicant who requests it because his claim for services is denied or is not acted upon with reasonable promptness.
(2) Any recipient who requests it because he or she believes the agency has taken an action erroneously.
(3) Any resident who requests it because he or she believes a skilled nursing facility or nursing facility has erroneously determined that he or she must be transferred or discharged.
(4) Any individual who requests it because he or she believes the State has made an erroneous determination with regard to the preadmission and annual resident review requirements of section 1919(e)(7) of the Act.
(5) Any MCO or PIHP enrollee who is entitled to a hearing under subpart F of part 438 of this chapter.
(6) Any PAHP enrollee who has an action as stated in this subpart.
(7) Any enrollee who is entitled to a hearing under subpart B of part 438 of this chapter.
(b) The agency need not grant a hearing if the sole issue is a Federal or State law requiring an automatic change adversely affecting some or all recipients.
(a) The agency may require that a request for a hearing be in writing.
(b) The agency may not limit or interfere with the applicant's or recipient's freedom to make a request for a hearing.
(c) The agency may assist the applicant or recipient in submitting and processing his request.
(d) The agency must allow the applicant or recipient a reasonable time, not to exceed 90 days from the date that notice of action is mailed, to request a hearings.
The agency—
(a) May respond to a series of individual requests for hearing by conducting a single group hearing;
(b) May consolidate hearings only in cases in which the sole issue involved is one of Federal or State law or policy;
(c) Must follow the policies of this subpart and its own policies governing hearings in all group hearings; and
(d) Must permit each person to present his own case or be represented by his authorized representative.
The agency may deny or dismiss a request for a hearing if—
(a) The applicant or recipient withdraws the request in writing; or
(b) The applicant or recipient fails to appear at a scheduled hearing without good cause.
(a) If the agency mails the 10-day or 5-day notice as required under § 431.211 or § 431.214 of this subpart, and the recipient requests a hearing before the date of action, the agency may not terminate or reduce services until a decision is rendered after the hearing unless—
(1) It is determined at the hearing that the sole issue is one of Federal or State law or policy; and
(2) The agency promptly informs the recipient in writing that services are to be terminated or reduced pending the hearing decision.
(b) If the agency's action is sustained by the hearing decision, the agency may institute recovery procedures against the applicant or recipient to recoup the cost of any services furnished the recipient, to the extent they were furnished solely by reason of this section.
(a) The agency may reinstate services if a recipient requests a hearing not more than 10 days after the date of action.
(b) The reinstated services must continue until a hearing decision unless, at the hearing, it is determined that the sole issue is one of Federal or State law or policy.
(c) The agency must reinstate and continue services until a decision is rendered after a hearing if—
(1) Action is taken without the advance notice required under § 431.211 or § 431.214 of this subpart;
(2) The recipient requests a hearing within 10 days of the mailing of the notice of action; and
(3) The agency determines that the action resulted from other than the application of Federal or State law or policy.
(d) If a recipient's whereabouts are unknown, as indicated by the return of unforwardable agency mail directed to him, any discontinued services must be reinstated if his whereabouts become known during the time he is eligible for services.
If the decision of a local evidentiary hearing is adverse to the applicant or recipient, the agency must—
(a) Inform the applicant or recipient of the decision;
(b) Inform the applicant or recipient that he has the right to appeal the decision to the State agency, in writing, within 15 days of the mailing of the notice of the adverse decision;
(c) Inform the applicant or recipient of his right to request that his appeal be a
(d) Discontinue services after the adverse decision.
(a) Unless the applicant or recipient specifically requests a
(b) A person who participates in the local decision being appealed may not participate in the State agency hearing decision.
(a) All hearings must be conducted—
(1) At a reasonable time, date, and place;
(2) Only after adequate written notice of the hearing; and
(3) By one or more impartial officials or other individuals who have not been directly involved in the initial determination of the action in question.
(b) If the hearing involves medical issues such as those concerning a diagnosis, an examining physician's report, or a medical review team's decision, and if the hearing officer considers it necessary to have a medical assessment other than that of the individual involved in making the original decision, such a medical assessment must be obtained at agency expense and made part of the record.
The hearing must cover—
(a) Agency action or failure to act with reasonable promptness on a claim for services, including both initial and subsequent decisions regarding eligibility;
(b) Agency decisions regarding changes in the type or amount of services;
(c) A decision by a skilled nursing facility or nursing facility to transfer or discharge a resident; and
(d) A State determination with regard to the preadmission screening and annual resident review requirements of section 1919(e)(7) of the Act.
The applicant or recipient, or his representative, must be given an opportunity to—
(a) Examine at a reasonable time before the date of the hearing and during the hearing:
(1) The content of the applicant's or recipient's case file; and
(2) All documents and records to be used by the State or local agency or the skilled nursing facility or nursing facility at the hearing;
(b) Bring witnesses;
(c) Establish all pertinent facts and circumstances;
(d) Present an argument without undue interference; and
(e) Question or refute any testimony or evidence, including opportunity to confront and cross-examine adverse witnesses.
If the hearing involves an issue of eligibility and the Medicaid agency is not responsible for eligibility determinations, the agency that is responsible for determining eligibility must participate in the hearing.
(a) Hearing recommendations or decisions must be based exclusively on evidence introduced at the hearing.
(b) The record must consist only of—
(1) The transcript or recording of testimony and exhibits, or an official report containing the substance of what happened at the hearing;
(2) All papers and requests filed in the proceeding; and
(3) The recommendation or decision of the hearing officer.
(c) The applicant or recipient must have access to the record at a convenient place and time.
(d) In any evidentiary hearing, the decision must be a written one that—
(1) Summarizes the facts; and
(2) Identifies the regulations supporting the decision.
(e) In a
(1) Specify the reasons for the decision; and
(2) Identify the supporting evidence and regulations.
(f) The agency must take final administrative action as follows:
(1) Ordinarily, within 90 days from the earlier of the following:
(i) The date the enrollee filed an MCO or PIHP appeal, not including the number of days the enrollee took to subsequently file for a State fair hearing; or
(ii) If permitted by the State, the date the enrollee filed for direct access to a State fair hearing.
(2) As expeditiously as the enrollee's health condition requires, but no later than 3 working days after the agency receives, from the MCO or PIHP, the case file and information for any appeal of a denial of a service that, as indicated by the MCO or PIHP—
(i) Meets the criteria for expedited resolution as set forth in § 438.410(a) of this chapter, but was not resolved within the timeframe for expedited resolution; or
(ii) Was resolved within the timeframe for expedited resolution, but reached a decision wholly or partially adverse to the enrollee.
(3) If the State agency permits direct access to a State fair hearing, as expeditiously as the enrollee's health condition requires, but no later than 3 working days after the agency receives, directly from an MCO or PIHP enrollee, a fair hearing request on a decision to deny a service that it determines meets the criteria for expedited resolution, as set forth in § 438.410(a) of this chapter.
(g) The public must have access to all agency hearing decisions, subject to the requirements of subpart F of this part for safeguarding of information.
The agency must notify the applicant or recipient in writing of—
(a) The decision; and
(b) His right to request a State agency hearing or seek judicial review, to the extent that either is available to him.
The agency must promptly make corrective payments, retroactive to the date an incorrect action was taken, and, if appropriate, provide for admission or readmission of an individual to a facility if—
(a) The hearing decision is favorable to the applicant or recipient; or
(b) The agency decides in the applicant's or recipient's favor before the hearing.
FFP is available in expenditures for—
(a) Payments for services continued pending a hearing decision;
(b) Payments made—
(1) To carry out hearing decisions; and
(2) For services provided within the scope of the Federal Medicaid program and made under a court order.
(c) Payments made to take corrective action prior to a hearing;
(d) Payments made to extend the benefit of a hearing decision or court order to individuals in the same situation as those directly affected by the decision or order;
(e) Retroactive payments under paragraphs (b), (c), and (d) of this section in accordance with applicable Federal policies on corrective payments; and
(f) Administrative costs incurred by the agency for—
(1) Transportation for the applicant or recipient, his representative, and witnesses to and from the hearing;
(2) Meeting other expenses of the applicant or recipient in connection with the hearing;
(3) Carrying out the hearing procedures, including expenses of obtaining the additional medical assessment specified in § 431.240 of this subpart; and
(4) Hearing procedures for Medicaid and non-Medicaid individuals appealing transfers, discharges and determinations of preadmission screening and annual resident reviews under part 483, subparts C and E of this chapter.
(a) Section 1902(a)(7) of the Act requires that a State plan must provide
(b) Section 1137 of the Act, which requires agencies to exchange information in order to verify the income and eligibility of applicants and recipients (see § 435.940ff), requires State agencies to have adequate safeguards to assure that—
(1) Information exchanged by the State agencies is made available only to the extent necessary to assist in the valid administrative needs of the program receiving the information, and information received under section 6103(l) of the Internal Revenue Code of 1954 is exchanged only with agencies authorized to receive that information under that section of the Code; and
(2) The information is adequately stored and processed so that it is protected against unauthorized disclosure for other purposes.
A State plan must provide, under a State statute that imposes legal sanctions, safeguards meeting the requirements of this subpart that restrict the use or disclosure of information concerning applicants and recipients to purposes directly connected with the administration of the plan.
Purposes directly related to plan administration include—
(a) Establishing eligibility;
(b) Determining the amount of medical assistance;
(c) Providing services for recipients; and
(d) Conducting or assisting an investigation, prosecution, or civil or criminal proceeding related to the administration of the plan.
The Medicaid agency must have authority to implement and enforce the provisions specified in this subpart for safeguarding information about applicants and recipients.
(a) The agency must publicize provisions governing the confidential nature of information about applicants and recipients, including the legal sanctions imposed for improper disclosure and use.
(b) The agency must provide copies of these provisions to applicants and recipients and to other persons and agencies to whom information is disclosed.
(a) The agency must have criteria that govern the types of information about applicants and recipients that are safeguarded.
(b) This information must include at least—
(1) Names and addresses;
(2) Medical services provided;
(3) Social and economic conditions or circumstances;
(4) Agency evaluation of personal information;
(5) Medical data, including diagnosis and past history of disease or disability; and
(6) Any information received for verifying income eligibility and amount of medical assistance payments (see § 435.940ff). Income information received from SSA or the Internal Revenue Service must be safeguarded according to the requirements of the agency that furnished the data.
(7) Any information received in connection with the identification of legally liable third party resources under § 433.138 of this chapter.
(a) The agency must have criteria specifying the conditions for release and use of information about applicants and recipients.
(b) Access to information concerning applicants or recipients must be restricted to persons or agency representatives who are subject to standards of confidentiality that are comparable to those of the agency.
(c) The agency must not publish names of applicants or recipients.
(d) The agency must obtain permission from a family or individual, whenever possible, before responding to a request for information from an outside source, unless the information is to be used to verify income, eligibility and the amount of medical assistance payment under section 1137 of this Act and §§ 435.940 through 435.965 of this chapter.
(e) The agency's policies must apply to all requests for information from outside sources, including governmental bodies, the courts, or law enforcement officials.
(f) If a court issues a subpoena for a case record or for any agency representative to testify concerning an applicant or recipient, the agency must inform the court of the applicable statutory provisions, policies, and regulations restricting disclosure of information.
(g) Before requesting information from, or releasing information to, other agencies to verify income, eligibility and the amount of assistance under §§ 435.940 through 435.965 of this chapter, the agency must execute data exchange agreements with those agencies, as specified in § 435.945(f).
(h) Before requesting information from, or releasing information to, other agencies to identify legally liable third party resources under § 433.138(d) of this chapter, the agency must execute data exchanges agreements, as specified in § 433.138(h)(2) of this chapter.
(a) All materials distributed to applicants, recipients, or medical providers must—
(1) Directly relate to the administration of the Medicaid program;
(2) Have no political implications except to the extent required to implement the National Voter Registration Act of 1993 (NVRA) Pub. L. 103-931; for States that are exempt from the requirements of NVRA, voter registration may be a voluntary activity so long as the provisions of section 7(a)(5) of NVRA are observed;
(3) Contain the names only of individuals directly connected with the administration of the plan; and
(4) Identify those individuals only in their official capacity with the State or local agency.
(b) The agency must not distribute materials such as “holiday” greetings, general public announcements, partisan voting information and alien registration notices.
(c) The agency may distribute materials directly related to the health and welfare of applicants and recipients, such as announcements of free medical examinations, availability of surplus food, and consumer protection information.
(d) Under NVRA, the agency must distribute voter information and registration materials as specified in NVRA.
(a)
(1) Section 1902(a)(9) of the Act, concerning the designation of State authorities to be responsible for establishing and maintaining health and other standards for institutions participating in Medicaid; and
(2) Section 1902(a)(33) of the Act, concerning the designation of the State licensing agency to be responsible for determining whether institutions and agencies meet requirements for participation in the State's Medicaid program.
(3) Section 1919(g)(1)(A) of the Act, concerning responsibilities of the State for certifying the compliance of non-State operated NFs with requirements of participation in the State's Medicaid program.
(b)
(c)
(d)
(2) The plan must provide that the Medicaid agency keeps these standards on file and makes them available to the Administrator upon request.
(e)
(1) The agency designated in paragraph (b) of this section, or another State agency responsible for licensing health institutions in the State, determines for the Medicaid agency whether institutions and agencies meet the requirements for participation in the Medicaid program; and
(2) The agency staff making the determination under paragraph (e)(1) of this section is the same staff responsible for making similar determinations for institutions or agencies participating under Medicare; and
(3) The agency designated in paragraph (e)(1) of this section makes recommendations regarding the effective dates of provider agreements, as determined under § 431.108.
(f)
(1) Federal requirements and the forms, methods and procedures that the Administrator designates will be used to determine provider eligibility and certification under Medicaid;
(2) Inspectors surveying the premises of a provider will—
(i) Complete inspection reports;
(ii) Note on completed reports whether or not each requirement for which an inspection is made is satisfied; and
(iii) Document deficiencies in reports;
(3) The survey agency will keep on file all information and reports used in determining whether participating facilities meet Federal requirements; and
(4) The survey agency will make the information and reports required under paragraph (f)(3) of this section readily accessible to HHS and the Medicaid agency as necessary—
(i) For meeting other requirements under the plan; and
(ii) For purposes consistent with the Medicaid agency's effective administration of the program.
(g)
(1) Review and evaluate medical and independent professional review team reports obtained under part 456 of this subchapter as they relate to health and safety requirements;
(2) Have qualified personnel perform on-site inspections periodically as appropriate based on the timeframes in the correction plan and—
(i) At least once during each certification period or more frequently if there is a compliance question; and
(ii) For non-State operated NFs, within the timeframes specified in § 488.308 of this chapter.
(3) Have qualified personnel perform on-site inspections—
(i) At least once during each certification period or more frequently if there is a compliance question; and
(ii) For intermediate care facilities with deficiencies as described in §§ 442.112 and 442.113 of this subchapter, within 6 months after initial correction plan approval and every 6 months thereafter as required under those sections.
(h)
(2) FFP is not available in any expenditures that the survey agency makes that are attributable to the State's overall responsibilities under State law and regulations for establishing and maintaining standards.
(a)
(1) State health agencies;
(2) State vocational rehabilitation agencies; and
(3) Grantees under title V of the Act, Maternal and Child Health and Crippled Children's Services.
(b)
“Title V grantee” means the agency, institution, or organization receiving Federal payments for part or all of the cost of any service program or project authorized by title V of the Act, including—
(1) Maternal and child health services;
(2) Crippled children's services;
(3) Maternal and infant care projects;
(4) Children and youth projects; and
(5) Projects for the dental health of children.
(c)
(1) Describe cooperative arrangements with the State agencies that administer, or supervise the administration of, health services and vocational rehabilitation services designed to make maximum use of these services;
(2) Provide for arrangements with title V grantees, under which the Medicaid agency will utilize the grantee to furnish services that are included in the State plan;
(3) Provide that all arrangements under this section meet the requirements of paragraph (d) of this section; and
(4) Provide, if requested by the title V grantee in accordance with the arrangements made under this section, that the Medicaid agency reimburse the grantee or the provider for the cost of services furnished recipients by or through the grantee.
(d)
(1) The mutual objectives and responsibilities or each party to the arrangement;
(2) The services each party offers and in what circumstances;
(3) The cooperative and collaborative relationships at the State level;
(4) The kinds of services to be provided by local agencies; and
(5) Methods for—
(i) Early identification of individuals under 21 in need of medical or remedial services;
(ii) Reciprocal referrals;
(iii) Coordinating plans for health services provided or arranged for recipients;
(iv) Payment or reimbursement;
(v) Exchange of reports of services furnished to recipients;
(vi) Periodic review and joint planning for changes in the agreements;
(vii) Continuous liaison between the parties, including designation of State and local liaison staff; and
(viii) Joint evaluation of policies that affect the cooperative work of the parties.
(e)
(a)
(b)
(c)
(1) The State authority or authorities concerned with mental diseases; and
(2) Any institution for mental diseases that is not under the jurisdiction of those State authorities, and that provides services under Medicaid to recipients aged 65 or older.
(d)
(1) Joint planning between the parties to the agreement;
(2) Development of alternative methods of care;
(3) Immediate readmission to an institution when needed by a recipient who is in alternative care;
(4) Access by the agency to the institution, the recipient, and the recipient's records when necessary to carry out the agency's responsibilities;
(5) Recording, reporting, and exchanging medical and social information about recipients; and
(6) Other procedures needed to carry out the agreement.
(a)
(b)
(c)
(2) Access by the agency to the State mental health and mental retardation authorities' records when necessary to carry out the agency's responsibilities;
(3) Recording, reporting, and exchanging medical and social information about individuals subject to PASARR;
(4) Ensuring that preadmission screenings and annual resident reviews are performed timely in accordance with §§ 483.112(c) and 483.114(c) of this part;
(5) Ensuring that, if the State mental health and mental retardation authorities delegate their respective responsibilities, these delegations comply with § 483.106(e) of this part;
(6) Ensuring that PASARR determinations made by the State mental
(7) Designating the independent person or entity who performs the PASARR evaluations for individuals with MI; and
(8) Ensuring that all requirements of §§ 483.100 through 483.136 are met.
(a)
(2) Section 1902(a)(10) of the Act (in clause (II) following subparagraph (D)), allows the State to pay the premium, deductibles, cost sharing, and other charges for recipients enrolled under Medicare Part B without obligating itself to provide the range of Part B benefits to other recipients; and
(3) Section 1903 (a)(1) and (b) of the Act authorizes FFP for State payment of Medicare Part B premiums for certain recipients.
(4) This section—
(i) Specifies the exception, relating to Part B coverage, from the requirement to provide comparable services to all recipients; and
(ii) Prescribes FFP rules concerning State payment for Medicare premiums and for services that could have been covered under Medicare.
(5) Section 1902(a)(15) of the Act requires that if a State chooses to pay only a portion of deductibles, cost sharing or other charges for recipients enrolled under Medicare Part B, the portion that is to be paid by a Medicaid recipient must be reasonably related to the recipient's income and resources.
(b)
(2) The State plan must specify this exception if it applies.
(c)
(2) If a State pays on a recipient's behalf any portion of the deductible or cost sharing amounts under Medicare Part B, the portion paid by a State must be reasonably related to the recipient's income and resources.
(d)
(2)
(i) AFDC families required to be covered under §§ 435.112 and 436.116 of this subchapter, those eligible for continued Medicaid coverage despite increased income from employment;
(ii) Recipients required to be covered under §§ 435.114, 435.134, and 436.112 of this subchapter, those eligible for continued Medicaid coverage despite increased income from monthly insurance benefits under title II of the Act;
(iii) Recipients required to be covered under § 435.135 of this subchapter, those eligible for continued Medicaid coverage despite increased income from cost-of-living increases under title II of the Act;
(iv) Recipients of foster care maintenance payments or adoption assistance
(v) Individuals required to be covered under § 435.120 of this chapter, that is, blind or disabled individuals who, under section 1619(b) of the Act, are considered to be receiving SSI;
(vi) Individuals who, in accordance with §§ 435.115 and 436.114 of this chapter are, for purposes of Medicaid eligibility, considered to be receiving AFDC. These are participants in a work supplementation program, or individuals denied AFDC because the payment would be less than $10;
(vii) Certain recipients of Veterans Administration pensions during the limited time they are, under section 310(b) of Pub. L. 96-272, considered as receiving SSI, mandatory State supplements, or AFDC;
(viii) Disabled children living at home to whom the State provides Medicaid under section 1902(e)(3) of the Act;
(ix) Individuals who become ineligible for AFDC because of the collection or increased collection of child or spousal support, but, in accordance with section 406(h) of the Act, remain eligible for Medicaid for four more months; and
(x) Individuals who become ineligible for AFDC because they are no longer eligible for the disregard of earnings of $30 or of $30 plus one-third of the remainder, but, in accordance with section 402(a)(37) of the Act, are considered as receiving AFDC for a period of 9 to 15 months.
(3) No FFP is available in State Medicaid expenditures that could have been paid for under Medicare Part B but were not because the person was not enrolled in Part B. This limit applies to all recipients eligible for enrollment under Part B, whether individually or through an agreement under section 1843(a) of the Act. However, FFP is available in expenditures required by §§ 435.914 and 436.901 of this subchapter for retroactive coverage of recipients.
(a) The State plan may provide for the review of Medicaid services through a contract with a QIO designated under Part 462 of this chapter. Medicaid requirements for medical and utilization review are deemed to be met for those services or providers subject to review under the contract.
(b) The State plan must provide that the contract with the QIO—
(1) Meets the requirements of § 434.6(a) of this part;
(2) Includes a monitoring and evaluation plan by which the State ensures satisfactory performance by the QIO;
(3) Identifies the services and providers subject to QIO review;
(4) Ensures that the review activities performed by the QIO are not inconsistent with QIO review activities of Medicare services and includes a description of whether and to what extent QIO determinations will be considered conclusive for Medicaid payment purposes.
(a)
(b)
(c)
(1) Coordinating operation of the Medicaid program with the State's operation of the Special Supplemental Food Program for Women, Infants, and Children;
(2) Providing timely written notice of the availability of WIC benefits to all individuals in the State who are determined to be eligible (including presumptively eligible) for Medicaid and who are:
(i) Pregnant women;
(ii) Postpartum women;
(iii) Breastfeeding women; and
(iv) Children under the age of 5.
(3) Referring individuals described under paragraphs (c)(2) (i) through (iv) of this section to the local agency responsible for administering the WIC program.
(d)
(2) The agency, no less frequently than annually, must also provide written notice of the availability of WIC benefits, including the location and telephone number of the local WIC agency or instructions for obtaining further information about the WIC program, to all Medicaid recipients (including those found to be presumptively eligible) who are under age 5 or who are women who might be pregnant, postpartum, or breastfeeding as described in paragraphs (c)(2) (i) through (iv) of this section.
(3) The agency must effectively inform those individuals who are blind or deaf or who cannot read or understand the English language.
(a)
(1) Section 2102(b)(3)(B) of the Act, which provides that children who apply for coverage under a separate child health plan under title XXI, but are found to be eligible for medical assistance under the State Medicaid plan, must be enrolled in the State Medicaid plan; and
(2) Section 2102(c)(2) of the Act, which requires coordination between a State child health program and other public health insurance programs.
(b)
(1) The applicant is not required to provide information or documentation that has been provided to the State agency responsible for determining eligibility under a separate child health program under title XXI and forwarded by such agency to the Medicaid agency on behalf of the child in accordance with § 457.350(f) of this chapter;
(2) Eligibility is determined in a timely manner in accordance with § 435.911 of this chapter;
(3) The Medicaid agency promptly notifies the State agency responsible for determining eligibility under a separate child health program when a child who was screened as potentially eligible for Medicaid is determined ineligible or eligible for Medicaid; and
(4) The Medicaid agency adopts a process that facilitates enrollment in a State child health program when a child is determined ineligible for Medicaid at initial application or redetermination.
This subpart implements sections 1903(a)(29) and 1908 of the Act which require that the State plan include a State program for licensing nursing home administrators.
Unless otherwise indicated, the following definitions apply for purposes of this subpart:
(a) A religious nonmedical institution as defined in § 440.170(b) of this chapter; or
(b) A distinct part of a hospital, if the hospital meets the definition in § 440.10 or § 440.140 of this subchapter, and the distinct part is not licensed separately or formally approved as a nursing home by the State even though it is designated or certified as a skilled nursing facility.
(a) Has an ownership interest in the home; or
(b) Shares his functions and duties with one or more other persons.
A State plan must provide that the State has a program for licensing administrators of nursing homes that meets the requirements of §§ 431.703 through 431.713 of this subpart.
The State licensing program must provide that only nursing homes supervised by an administrator licensed in accordance with the requirements of this subpart may operate in the State.
If a State licensing law does not use the term “nursing home,” the CMS Administrator will determine the term or terms equivalent to “nursing home” for purposes of applying the requirements of this subpart. To obtain this determination, the Medicaid agency must submit to the Regional Medicaid Director copies of current State laws that define institutional health care facilities for licensing purposes.
(a) The State licensing program must provide for licensing of nursing home administrators by—
(1) The agency designated under the healing arts act of the State; or
(2) A State licensing board.
(b) The State agency or board must perform the functions and duties specified in §§ 431.707 through 431.713 and the board must meet the membership requirements specified in § 431.706 of this subpart.
(a) The board must be composed of persons representing professions and institutions concerned with the care and treatment of chronically ill or infirm elderly patients. However—
(1) A majority of the board members may not be representative of a single profession or category of institution; and
(2) Members not representative of institutions may not have a direct financial interest in any nursing home.
(b) For purposes of this section, nursing home administrators are considered representatives of institutions.
(a) The agency or board must develop, impose, and enforce standards that must be met by individuals in order to be licensed as a nursing home administrator.
(b) The standards must be designed to insure that nursing home administrators are—
(1) Of good character;
(2) Otherwise suitable; and
(3) Qualified to serve because of training or experience in institutional administration.
The agency or board must develop and apply appropriate procedures and techniques, including examinations and investigations, for determining if a person meets the licensing standards.
Except as provided in § 431.714 of this subpart, the agency or board must—
(a) Issue licenses to persons who meet the agency's or board's standards; and
(b) Revoke or suspend a license if the agency or board determines that the person holding the license substantially fails to meet the standards.
To fill a position of nursing home administrator that unexpectedly becomes vacant, the agency or board may issue one provisional license, for a single period not to exceed 6 months. The license may be issued to a person who does not meet all of the licensing requirements established under § 431.707 but who—
(a) Is of good character and otherwise suitable; and
(b) Meets any other standards established for provisional licensure by the agency or board.
The agency or board must establish and carry out procedures to insure that licensed administrators comply with the standards in this subpart when they serve as nursing home administrators.
The agency or board must investigate and act on all complaints it receives of violations of standards.
The agency or board must conduct a continuing study of nursing homes and administrators within the State to improve—
(a) Licensing standards; and
(b) The procedures and methods for enforcing the standards.
The agency or board may waive any standards developed under § 431.707 of this subpart for any person who has served in the capacity of a nursing home administrator during all of the 3 calendar years immediately preceding the calendar year in which the State first meets the requirements in this subpart.
No FFP is available in expenditures by the licensing board for establishing and maintaining standards for the licensing of nursing home administrators.
This subpart—
(a) Establishes State plan requirements for a Medicaid eligibility quality control (MEQC) program designed to reduce erroneous expenditures by monitoring eligibility determinations and a claims processing assessment system that monitors claims processing operations.
(b) Establishes rules and procedures for disallowing Federal financial participation (FFP) in erroneous Medicaid payments due to eligibility and recipient liability errors as detected through the MEQC program.
This subpart implements the following sections of the Act, which establish requirements for State plans and for payment of Federal financial participation (FFP) to States:
1902(a)(4) Administrative methods for proper and efficient operation of the State plan.
1903(u) Limitation of FFP for erroneous medical assistance expenditures.
As used in this subpart—
(1) For a service not authorized under the State plan;
(2) To a provider not certified for participation in the Medicaid program;
(3) For a service already paid for by Medicaid; or
(4) In an amount above the allowable reimbursement level for that service.
(1) Was ineligible when authorized or when he received services; or
(2) Was eligible for Medicaid but was ineligible for certain services he received; or
(3) Had not met recipient liability requirements when authorized eligible for Medicaid; that is, he had not incurred medical expenses equal to the amount of his excess income over the State's financial eligibility level or he had incurred medical expenses that exceeded the amount of excess income over the State's financial eligibility level, or was making an incorrect amount of payment toward the cost of services.
(a)
(b)
Any individual performing activities under the MEQC program or the claims processing assessment system specified in this subpart must do so in a manner that is consistent with the provisions of §§ 435.902 and 436.901 of this subchapter concerning the rights of recipients.
(a)
(b)
(c)
(a)
(2) The agency is not required to conduct reviews of the following cases:
(i) Supplemental Security Income (SSI) recipient cases in States with contracts under section 1634 of the Act for determining Medicaid eligibility;
(ii) Foster care and adoption assistance cases under title IV-E of the Act found eligible for Medicaid; and
(iii) Cases under programs that are 100 percent federally funded.
(b)
(c)
(2)
(3)
(i) Clearly define the purpose of the system and demonstrate how the system is superior to the current negative case review requirements.
(ii) Contain a methodology for identifying significant problem areas that could result in erroneous denials, suspensions, and terminations of applicants and recipients. Problem areas selected for review must contain at least as many applicants and recipients as were included in the negative case sample size previously required for the State.
(iii) Provide a detailed methodology describing how the extent of the problem area will be measured through sampling and review procedures, the findings expected from the review, and planned corrective actions to resolve the problem.
(iv) Include documentation supporting the use of the system methodology. Documentation must include the timeframes under which the system will be operated.
(v) Provide a superior means of monitoring denials, terminations, and suspensions than that required under paragraph (b) of this section.
(vi) Provide a statistically valid error rate that can be projected to the universe that is being studied.
(d)
(1) Ineligibility for Medicaid;
(2) Ineligibility for certain Medicaid services; and
(3) Recipient understated or overstated liability.
(e)
(1) Examine and analyze each case record for all cases under review to establish what information is available for use in determining eligibility in the review month;
(2) Conduct field investigations including in-person recipient interviews for each case in the active case sample, and conduct in-person interviews only
(3) Verify all appropriate elements of eligibility for active cases through at least one primary source of evidence or two secondary sources of evidence as defined by CMS by documentation or by collateral contacts as required, or both, and fully record the information on the appropriate forms;
(4) Determine the basis on which eligibility was established and the eligibility status of the active case and each case member;
(5) Collect copies of State paid claims or recipient profiles for services delivered during the review month and, if indicated, any months prior to the review month in the agency's selected spenddown period, for all members of the active case under review;
(6) Associate dollar values with eligibility status for each active case under review; and
(7) Complete the payment, case, and review information for all individuals in the active case under review on the appropriate forms.
(a)
(b)
(1) The population to be sampled;
(2) The list(s) from which the sample is selected and the following characteristics of the list(s):
(i) Sources;
(ii) All types of cases in the selection lists;
(iii) Accuracy and completeness of sample lists in reference to the population(s) of interest;
(iv) Whether or not the selection list was constructed by combining more than one list;
(v) The form of the selection list (whether the list or part of the list is automated);
(vi) Frequency and length of delays in updating the selection lists or their sources;
(vii) Number of items on the lists and proportion of listed-in-error items:
(viii) Methods of deleting unwanted items from the selection lists; and
(ix) Structure of the selection lists.
(3) The sample size, including the minimum number of reviews to be completed and the expected number of cases to be selected. Minimum sample sizes are based on the State's relative level of Medicaid annual expenditures for services for active cases, and on the total number of negative case actions in the universe for negative cases. When the sample is substratified, there can be no fewer than 75 cases in each substratum, except as provided in paragraph (c) of this section or as provided in an exception documented in an approved sampling plan which contains a statement accepting the precision and reliability of the reduced sample.
(4) The sample selection procedure. Systematic random sampling is recommended. Alternative procedures must provide a representative sample, conform to principles of probability sampling, and yield estimates with the same or better precision than achieved in systematic random sampling.
(5) Procedures used to identify amounts paid for services received in the review month.
(6) Specification as to whether the agency chooses to—
(i) Use billed amounts to offset recipient liability toward cost of care (No indication will be interpreted to mean that the agency will use paid claims); and
(ii) Use denied claims to offset recipient liability toward cost of care in the payment review. (No indication will be interpreted to mean denied claims will not be used.)
(7) Indication of whether the agency opts to drop or complete cases selected more than once in a sample period. (No indication will be interpreted to mean that the agency will complete cases selected more than once.)
(c)
(1) All States must use the AFDC quality control sample for the AFDC stratum.
(2) States must include in the MAO stratum all cases certified as eligible for Medicaid that are not in the AFDC stratum, excluding individuals specified in paragraph (c)(4) of this section.
(3) States that do not have an agreement with the Social Security Administration under section 1634 of the Act and do not have more restrictive eligibility criteria under section 1902(f) of the Act but require a separate Medicaid application for recipients of SSI and determine Medicaid eligibility using SSI criteria must divide the MAO stratum into two substrata: MAO cases and SSI cash cases for the first review period beginning after July 1, 1990 and for review periods thereafter. The SSI substratum sample size must be 75 cases or one-half of the total MAO sample, whichever is smaller. The non-SSI MAO substratum sample will be the remainder of the MAO stratum cases.
(4) States must exclude from the MEQC universe SSI beneficiaries whose eligibility determinations were made exclusively by the Social Security Administration under an agreement under section 1634 of the Act, individuals in foster care or receiving adoption assistance whose eligibility is determined under title IV-E of the Act, and individuals receiving Medicaid under programs that are 100 percent federally funded.
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(1)
(2)
(i) Draw an initial case sample size each month that is no less than 5 times the required sample size. The sample will be selected from the universe of cases that were certified eligible in the fourth month prior to the month of case selection;
(ii) Identify claims paid for services furnished to all individuals during the review month (and, if indicated, any months prior to the review month in the agency's selected spenddown period) for these cases;
(iii) Stratify the cases by dollar value of the claims into three strata; and
(iv) Select a second statistically valid sample within each group subject to the sample size requirements specified in paragraph (b)(3) or (j)(1) of this section.
(a) The agency must complete case reviews and submit reports of findings to CMS as specified in paragraph (b) of this section in the form and at the time specified by CMS.
(b) In addition to the reporting requirements specified in § 431.814 relating to sampling, the agency must complete case reviews and submit reports of findings to CMS in accordance with paragraphs (b)(1) through (6) of this section for review periods beginning after July 1, 1990. The agency must not combine or otherwise integrate case findings from the MAO and AFDC strata to meet the case percentage deadlines as specified in paragraphs (b)(1) through (6) of this section.
(1)
(ii) The agency must submit a report on cases selected for the review month.
(2)
(ii) The agency must report findings electronically through the system prescribed by CMS for 100 percent of the State agency-reported eligible individuals within 30 days after the final timeframe required by the AFDC program as specified in program regulations at 45 CFR 205.40(b)(2)(ii).
(3)
(4)
(ii) The agency must complete payment review findings for 100 percent of the active case reviews in its sample and report the findings within 60 days after the first day of the month in which the claims collection process begins. The agency must wait 5 months after the end of each review month before associating the amount of claims paid for each case for services furnished during the review month unless retrospective sampling is elected.
(iii) The agency must make any necessary corrections to claims payments during the month the claim is paid and the following month. CMS will take necessary action to reject any State adjustment adversely affecting the error rate, for example, by not paying claims on error cases.
(5)
(6)
(a) The agency, upon written request, must mail to the HHS staff all records, including complete local agency eligibility case files or legible copies and all other documents pertaining to its MEQC reviews to which the State has access, including information available under part 435, subpart I, of this chapter.
(b) The agency must mail requested records within 10 working days of receipt of a request, unless the State has an alternate method of submitting these records that is approved by CMS or has received, on an as-needed basis, approval from CMS to extend this timeframe by 3 additional working days to allow for exceptional circumstances.
The agency must—
(a) Take action to correct any active or negative case action errors found in the sample cases;
(b) Take administrative action to prevent or reduce the incidence of those errors; and
(c) By September 15 each year, submit to CMS a report on its error rate analysis and a corrective action plan based on that analysis. The agency must submit revisions to the plan within 60 days of identification of additional error-prone areas, other significant changes in the error rate (that is, changes that the State experiences that increase or decrease its error rate and necessitate immediate corrective action or discontinuance of corrective actions that effectively control the cause of the error rate change), or changes in planned corrective action.
(a) When a difference exists between State and Federal case eligibility or payment findings, the Regional Office will notify the agency by a difference letter.
(b) The agency must return the difference letter to the Regional Office within 28 calendar days of the date of the letter indicating either agreement with the Federal finding or reasons for disagreement and if the agency desires a conference to resolve the difference. This period may be shortened if the Regional Office finds that it is necessary to do so in order to meet a case completion deadline, and the State still has a reasonable period of time in which to respond to the letter. If the agency fails to submit the difference letter indicating its agreement or disagreement
(c) If the Regional Office disagrees with the agency's response, a difference conference will be scheduled within 20 days of the request of the agency. If a difference cannot be resolved, the State may request a direct presentation of its position to the Regional Administrator. The Regional Administrator has final authority for resolving the difference.
An agency must—
(a) Operate the MQC claims processing assessment system in accordance with the policies, sampling methodology, review procedures, reporting forms, requirements, and other instructions established by CMS.
(b) Identify deficiencies in the claims processing operations.
(c) Measure cost of deficiencies;
(d) Provide data to determine appropriate corrective action;
(e) Provide an assessment of the State's claims processing or that of its fiscal agent;
(f) Provide for a claim-by-claim review where justifiable by data; and
(g) Produce an audit trail that can be reviewed by CMS or an outside auditor.
(a) The agency must submit reports and data specified in paragraph (b) of this section to CMS, in the form and at the time specified by CMS.
(b) Except when CMS authorizes less stringent reporting, States must submit:
(1) A monthly report on claims processing reviews sampled and or claims processing reviews completed during the month;
(2) A summary report on findings for all reviews in the 6-month sample to be submitted by the end of the 3rd month following the scheduled completion of reviews for that 6 month period; and
(3) Other data and reports as required by CMS.
The agency, upon written request, must provide HHS staff with access to all records pertaining to its MQC claims processing assessment system reviews to which the State has access, including information available under part 435, subpart J, of this chapter.
The agency must—
(a) Take action to correct those errors identified through the claims processing assessment system review and, if cost effective, to recover those funds erroneously spent;
(b) Take administrative action to prevent and reduce the incidence of those errors; and
(c) By August 31 of each year, submit to CMS a report of its error analysis and a corrective action plan on the reviews conducted since the cut-off-date of the previous corrective action plan.
(a)
(1)
(2)
(b)
(1) The amount of excess income that must be offset with incurred medical expenses to gain eligibility; or
(2) The amount of payment a recipient must make toward the cost of services.
(1) Was ineligible for the review month or, if full month coverage is not provided, at the time services were received;
(2) Was ineligible to receive a service provided during the review month; or
(3) Had not properly met enrollee liability requirements prior to receiving Medicaid services.
(4) The term does not include payments made for care and services covered under the State plan and furnished to children during a presumptive eligibility period as described in § 435.1102 of this chapter.
(c)
(2) A payment error rate for each State is determined by CMS for each annual assessment period by computing the statistical estimate of the ratio of erroneous payments for medical assistance made on behalf of individuals or cases in the sample for services received during the review month to total expenditures for medical assistance for that State made on behalf of individuals or cases in the sample for services received during the review month. This ratio incorporates the findings of a federally re-reviewed subsample of the State's review findings and is projected to the universe of total medical assistance payments for calculating the amount of disallowance under paragraph (d)6) of this section.
(3) The State's payment error rate does not include payments made on behalf of individuals whose eligibility determinations were made exclusively by the Social Security Administration under an agreement under section 1634 of the Act or children found eligible for foster care and adoption assistance under title IV-E of the Act.
(4) The amount of erroneous payments is determined as follows:
(i) For ineligible cases resulting from excess resources, the amount of error is the lesser of—
(A) The amount of the payment made on behalf of the family or individual for the review month; or
(B) The difference between the actual amount of countable resources of the family or individual for the review month and the State's applicable resources standard.
(ii) For ineligible cases resulting from other than excess resources, the amount of error is the total amount of medical assistance payments made for the individual or family under review for the review month.
(iii) For erroneous payments resulting from failure to properly meet beneficiary liability, the amount of error is the lesser of—
(A) The amount of payments made on behalf of the family or individual for the review month; or
(B) The difference between the correct amount of beneficiary liability and the amount of beneficiary liability met by the individual or family for the review month.
(iv) The amount of payments made for services provided during the review month for which the individual or family was not eligible.
(5) In determining the amount of erroneous payments, errors caused by technical errors are not included.
(6) If a State fails to cooperate in completing a valid MEQC sample or individual reviews in a timely and appropriate fashion as required, CMS will establish the State's payment error rate based on either—
(i) A special sample or audit;
(ii) The Federal subsample; or
(iii) Other arrangements as the Administrator may prescribe.
(7) When it is necessary for CMS to exercise the authority in paragraph (c)(6) of this section, the amount that would otherwise be payable to the State under title XIX of the Act is reduced by the full costs incurred by CMS in making these determinations. CMS may make these determinations either directly or under contractual or other arrangements.
(d)
(2) If the State believes that the anticipated error rate established in accordance with paragraph (d)(1) of this section is based on erroneous data, the State may submit evidence that demonstrates the data were erroneous. If the State satisfactorily demonstrates that CMS's data were erroneous, the State's anticipated error rate will be adjusted accordingly. Submittal of evidence is subject to the following conditions:
(i) The State must inform CMS of its intent to submit evidence at least 70 days prior to the beginning of the quarter.
(ii) The State may request copies of data that CMS used to compute its anticipated error rate within 7 days of receiving notification of its projected error rate.
(iii) The State has up to 40 days before the quarter begins to present the evidence.
(iv) The evidence is restricted to documentation of suspected CMS data entry errors, processing errors, and resolutions of Federal subsample difference cases subsequent to calculation of the error rate projection as contained in the original notice to the State.
(v) The State may not submit other evidence, such as that consisting of revisions to State errors as a result of changes to the original State review findings submitted to CMS.
(vi) The State may not submit evidence challenging the error rate computational methodology.
(3) Based on the anticipated error rate established in paragraph (d)(1) or (d)(2) of this section, CMS reduces its estimate of the State's requirements for FFP for medical assistance for the quarter by the percentage by which the anticipated payment error rate exceeds the 3-percent national standard. This reduction is applied against CMS's total estimate of FFP for medical assistance expenditures (less payments to Supplemental Security Income beneficiaries in 1634 contract States and payments to children found eligible for foster care and adoption assistance
(4) After the end of each quarter, an adjustment to the reduction will be made based on the State's actual expenditures.
(5) After the actual payment error rate has been established for each annual assessment period, CMS will compute the actual amount of the disallowance and adjust the FFP payable to each State based on the difference between the amounts previously withheld for each of the quarters during the appropriate assessment period and the amount that should have been withheld based on the State's actual final error rate. If CMS determines that the amount withheld for the period exceeds the amount of the actual disallowance, the excess amount withheld will be returned to the States through the normal grant awards process within 30 days of the date the actual disallowance is calculated.
(6) CMS will compute the amount to be withheld or disallowed as follows:
(i) Subtract the 3-percent national standard from the State's anticipated or actual payment error rate percentage.
(ii) If the difference is greater than zero, the Federal medical assistance funds for the period, excluding payments for those individuals whose eligibility for Medicaid was determined exclusively by the Social Security Administration under a section 1634 agreement and children found eligible for foster care and adoption assistance under title IV-E of the Act, are multiplied by that percentage. This product is the amount of the disallowance or withholding.
(7) A State's payment error rate for an annual assessment period is the weighted average of the payment error rates in the two 6-month review periods comprising the annual assessment period.
(8) The weights are established as the percent of the total annual payments, excluding payments for those individuals whose eligibility for Medicaid was determined exclusively by the Social Security Administration under a section 1634 agreement and children found eligible for foster care and adoption assistance under title IV-E of the Act, that occur in each of the 6-month periods.
(e)
(i) The State has 65 days from the date of receipt of this notification to show that this disallowance should not be made because it failed to meet the national standard despite a good faith effort to do so.
(ii) If CMS is satisfied that the State did not meet the national standard despite a good faith effort, CMS may reduce the funds being disallowed in whole or in part as it finds appropriate under the circumstances shown by the State.
(iii) A finding that a State did not meet the national standard despite a good faith effort will be limited to extraordinary circumstances.
(iv) The burden of establishing that a good faith effort was made rests entirely with the State.
(2) Some examples of circumstances under which CMS may find that a State did not meet the national standard despite a good faith effort are—
(i) Disasters such as fire, flood, or civil disorders that—
(A) Require the diversion of significant personnel normally assigned to Medicaid eligibility administration; or
(B) Destroyed or delayed access to significant records needed to make or maintain accurate eligibility determinations;
(ii) Strikes of State staff or other government or private personnel necessary to the determination of eligibility or processing of case changes;
(iii) Sudden and unanticipated workload changes that result from changes in Federal law and regulation, or rapid,
(iv) State actions resulting from incorrect written policy interpretations to the State by a Federal official reasonably assumed to be in a position to provide that interpretation; and
(v) The State has taken the action it believed was needed to meet the national standard, but the national standard was not met. CMS will consider request for a waiver under this criterion only if a State has achieved an error rate for the sample period that (after reducing the error rate by taking into account the cases determined by CMS to be in error as a result of conditions listed in paragraphs (e)(2) (i) through (iv) of this section) is less than its error rate for the preceding sample year and does not exceed the national mean error rate for the sample period under review (unless that national mean error rate is at or below the 3-percent national standard). If the agency has met this error reduction requirement or had error rates of 3 percent or below for the prior two review periods, and its error rate for the review period under consideration is less than one-third above the national standard, CMS will evaluate a request for a good faith waiver based on the following factors:
(A) The State has fully met the performance standards in the operation of a quality control system in accordance with Federal regulations and CMS guidelines (e.g., adherence to Federal case completion timeliness requirements and verification standards).
(B) The State has achieved substantial performance in the formulation of error reduction initiatives based on the following processes:
(
(
(
(C) The State has achieved substantial performance in the operation of the following systems supported by evidence of the timely utilization of their outputs in the determination of case eligibility:
(
(
(D) The State has achieved substantial performance in the use of the following accountability mechanisms to ensure that agency staff adhere to error reduction initiatives. The following are minimum requirements:
(
(
(
(vi) A State that meets the performance standards specified in paragraphs (e)(2)(v) (A) through (D) of this section will be considered for a full or partial waiver of its disallowance amount. The State must submit only specific documentation that verifies that the necessary actions were accomplished. For example, a State could submit worker performance standards reflecting timeliness and case accuracy as quantitative measures of performance.
(3) The failure of a State to act upon necessary legislative changes or to obtain budget authorization for needed
(f)
(2) This appeal provision, as it applies to MEQC disallowances, is not applicable to the Administrator's decision on a State's waiver request provided for under paragraph (e) of this section.
This subpart requires States and providers to submit information necessary to enable the Secretary to produce national improper payment estimates for Medicaid and the State Children's Health Insurance Program (SCHIP).
(a)
(b)
(2) All information must be furnished in accordance with section 1902(a)(7)(A) of the Act, regarding confidentiality.
(3) This subpart does not apply with respect to Puerto Rico, Guam, the Virgin Islands, the Northern Mariana Islands or American Samoa.
(a) States must submit information to the Secretary for, among other purposes, estimating improper payments in Medicaid and SCHIP, that include but are not limited to—
(1) All adjudicated fee-for-service (FFS) and managed care claims information, on a quarterly basis, from the review year;
(2) Upon request from CMS, provider contact information that has been verified by the State as current;
(3) All medical and other related policies in effect and any quarterly policy updates;
(4) Current managed care contracts, rate information, and any quarterly updates applicable to the review year for SCHIP and, as requested, for Medicaid;
(5) Data processing systems manuals;
(6) Repricing information for claims that are determined during the review to have been improperly paid;
(7) Information on claims that were selected as part of the sample, but changed in substance after selection, for example, successful provider appeals;
(8) Adjustments made within 60 days of the adjudication dates for the original claims or line items with sufficient information to indicate the nature of the adjustments and to match the adjustments to the original claims or line items;
(9) For the eligibility improper payment measurement, information as set forth in § 431.978 through § 431.988;
(10) A corrective action plan for purposes of reducing erroneous payments in FFS, managed care, and eligibility; and
(11) Other information that the Secretary determines is necessary for, among other purposes, estimating improper payments and determining error rates in Medicaid and SCHIP.
(b) Providers must submit information to the Secretary for, among other purposes, estimating improper payments in Medicaid and SCHIP, which include but are not limited to, Medicaid and SCHIP beneficiary medical records.
(a)
(2) The agency and personnel responsible for the development, direction, implementation, and evaluation of the eligibility reviews and associated activities, including calculation of the error rates under this section, must be functionally and physically separate from the State agencies and personnel that are responsible for Medicaid and SCHIP policy and operations, including eligibility determinations.
(3) Any individual performing activities under this section must do so in a manner that is consistent with the provisions of § 435.901, concerning the rights of recipients.
(b)
(c)
(a)
(b)
(c)
(d)
(1)
(ii)
(2)
(3)
(i) Program applications completed by the beneficiaries in which the State took action in the sample month to approve such beneficiaries for Medicaid or SCHIP based on the eligibility determination.
(ii) Redeterminations of eligibility in which the State took action in the sample month to approve the beneficiaries for Medicaid or SCHIP based on information obtained through the completed redetermination.
(iii) All other cases.
(4)
(a)
(b)
(c)
(d)
(1)
(i) Review the cases specified at § 431.978(d)(3)(i) and § 431.978(d)(3)(ii) in accordance with the State's categorical and financial eligibility criteria as of the review month and identify with a specific beneficiary payments made on behalf of such beneficiary for services received in the first 30 days of eligibility or in the review month;
(ii) For cases specified in § 431.978(d)(3)(iii), if the last action was 12 months prior to the sample month, review in accordance with the State's categorical and financial eligibility criteria as of the last action and identify with a specific beneficiary payments made on behalf of such beneficiary for services received in the sample month. If the last action occurred more than 12 months prior to the sample month, review in accordance with the State's categorical and financial eligibility criteria as of the sample month and identify payments made on behalf of the specific beneficiary for services received in the sample month;
(iii) Examine the evidence in the case file that supports categorical and financial eligibility for the category of coverage in which the case is assigned, and independently verify information that is missing, older than 12 months, likely to change, based on self declaration, or otherwise as needed, to verify eligibility; and
(iv) For managed care cases, also verify residency and eligibility for and actual enrollment in the managed care plan during the month under review.
(v) If the case is ineligible under paragraphs (d)(1)(i) through (d)(1)(iv) of this section, review the case to determine whether the case is eligible under any coverage category within the program.
(vi) As a result of paragraphs (d)(1)(i) through (d)(1)(v) of this section—
(A) Cite the case as eligible or ineligible based on the review findings and identify with the particular beneficiary the payments made on behalf of the particular beneficiary for services received in the first 30 days of eligibility, the review month or sample month, as appropriate; or
(B) Cite the case as undetermined if after due diligence an eligibility determination could not be made and identify with the particular beneficiary the payments made on behalf of the particular beneficiary for services received in the first 30 days of eligibility, the review month or sample month, as appropriate.
(2)
(i) Cite the case as eligible or ineligible based on the review findings and identify with the particular beneficiary the payments made on behalf of the particular beneficiary for services received in the review month or sample month, as appropriate; or
(ii) Cite the case as undetermined if after due diligence an eligibility determination could not be made and identify with the particular beneficiary the payments made on behalf of the particular beneficiary for services received in the review month or sample month, as appropriate.
(e)
(1) Identify the reason the State agency determined ineligibility;
(2) Examine the evidence in the case file to determine whether the State agency's denial or termination was correct or whether there is any reason the case should have been denied or terminated; and
(i) Record the State agency's finding as correct if the case record review substantiates that the individual was not eligible; or
(ii) Record the case as an error if there is no valid reason for the denial or termination.
(a) States must complete and report to CMS the findings, including the error causes if known, for all active case reviews listed on the monthly sample selection lists, including cases dropped from review due to active fraud investigations and cases for which eligibility could not be determined. States must submit a summary report of the active case eligibility and payment review findings to CMS by July 1 following the review year.
(b) The agency must report by July 1 following the review year, information as follows:
(1) Case and payment error rates for active cases.
(2) Case error rates for negative cases.
(3) The number and amounts of undetermined cases in the sample and the total amount of payments from all undetermined cases.
(4) The number of cases dropped from review due to active fraud investigations.
The State agency must submit to CMS a corrective action plan to reduce improper payments in its Medicaid and SCHIP programs based on its analysis of the error causes in the FFS, managed care, and eligibility components.
(a) The State may file, in writing, a request with the Federal contractor to resolve differences in the Federal contractor's findings based on medical or data processing reviews on FFS and managed care claims in Medicaid and SCHIP. The State must have a factual basis for filing the difference and must provide the Federal contractor with valid evidence directly related to the error finding to support the State's position that the claim was properly paid.
(b) For a claim in which the State and the Federal contractor cannot resolve the difference in findings, the State may appeal to CMS for final resolution.
(1) The difference in findings must be in the amount of $100 or greater; and
(2) The agency must provide CMS with the facts and valid documentation to support its determination that the claim was correctly paid, as well as the Federal contractor's justification for upholding its initial error finding.
(3) CMS will make the final decision on the claim. There will be no further judicial or administrative review of CMS' decision.
(c) All differences, including those pending in CMS for final decision that are not resolved in time to be included in the error rate calculation, will be considered as errors for meeting the reporting requirements of the IPIA. Upon State request, CMS will calculate a subsequent State-specific error rate that reflects any reversed disposition of the unresolved claims.
(a)
(b)
Sec. 1102 of the Social Security Act (42 U.S.C. 1302).
This part prescribes regulations to implement section 1902(a)(4) of the Act, which relates to a merit system of State personnel administration and training and use of subprofessional staff and volunteers in State Medicaid programs, and section 1903(a), rates of FFP for Medicaid staffing and training costs. It also prescribes regulations, based on the general administrative authority in section 1902(a)(4), for State training programs for all staff.
As used in this part—
(a)
(b)
(c)
(1) [Reserved]
(2) 5 CFR part 900, subpart F, Administration of the Standards for Merit System of Personnel Administration.
(d)
(e)
(1) Assure that the U.S. Civil Service Commission has determined the adequacy of current State laws, regulations, and policy statements that effect methods of personnel administration in conformity with the standards, and
(2) Submit any changes in them to the Commission for review.
(f)
(g)
(h)
(a) A State plan must provide for a program of training for Medicaid agency personnel. (See also §§ 432.31 and 432.32 for training programs for subprofessional staff and for volunteers.)
(b) The program must—
(1) Include initial inservice training for newly appointed staff, and continuing training opportunities to improve the operation of the program;
(2) Be related to job duties performed or to be performed by the persons trained; and
(3) Be consistent with the program objectives of the agency.
(a)
(b)
(1) Young, middle-aged, and older persons;
(2) Physically and mentally disabled; and
(3) Recipients.
(c)
(d)
(e)
(1) To enter employment at the subprofessional level; and
(2) To progress to positions of increasing responsibility and reward:
(i) In accordance with their abilities; and
(ii) Through work experience and pre-service and in-service training.
(f)
(g)
(1) An appropriate ratio of subprofessional and professional staff has been achieved; and
(2) There is maximum use of subprofessional staff as community aides in the operation of the program.
(a)
(b)
(1) Providing services to applicants and recipients; and
(2) Assisting any advisory committees established by the agency.
(c)
(1) The development, organization, and administration of the volunteer program; and
(2) Coordination of the program with related functions.
(d)
(1) Methods of recruitment and selection that assure participation of volunteers of all income levels, in planning capacities and service provision; and
(2) A program of organized training and supervision of volunteers.
(e)
(1) Reimburse volunteers for actual expenses incurred in providing services; and
(2) Assure that no volunteer is deprived of the opportunity to serve because of the expenses involved.
(f)
The rates of FFP specified in this subpart C do not apply to State personnel who conduct survey activities and certify facilities for participation in Medicaid, as provided for under section 1902(a)(33)(B) of the Act.
(a)
(b)
(2) For personnel engaged directly in the operation of mechanized claims processing and information retrieval systems, the rate is 75 percent.
(3) For personnel engaged in the design, development, or installation of mechanized claims processing and information retrieval systems, the rate is 50 percent for training and 90 percent for all other costs specified in paragraph (a) of this section.
(4) [Reserved]
(5) For personnel administering family planning services and supplies, the rate is 90 percent.
(6) For all other staff of the Medicaid agency or other public agencies providing services to the Medicaid agency, and for training and other expenses of volunteers, the rate is 50 percent.
(c)
(2) Rates of FFP in excess of 50 percent apply only to those portions of the individual's working time that are spent carrying out duties in the specified areas for which the higher rate is authorized.
(3) The allocation of personnel and staff costs must be based on either the actual percentages of time spent carrying out duties in the specified areas, or another methodology approved by CMS.
(d)
(i) The expenditures are for activities that are directly related to the administration of the Medicaid program, and as such do not include expenditures for medical assistance;
(ii) The skilled professional medical personnel have professional education and training in the field of medical care or appropriate medical practice. “Professional education and training” means the completion of a 2-year or longer program leading to an academic degree or certificate in a medically related profession. This is demonstrated by possession of a medical license, certificate, or other document issued by a recognized National or State medical licensure or certifying organization or a degree in a medical field issued by a college or university certified by a professional medical organization. Experience in the administration, direction, or implementation of the Medicaid program is not considered the equivalent of professional training in a field of medical care.
(iii) The skilled professional medical personnel are in positions that have duties and responsibilities that require those professional medical knowledge and skills.
(iv) A State-documented employer-employee relationship exists between the Medicaid agency and the skilled professional medical personnel and directly supporting staff; and
(v) The directly supporting staff are secretarial, stenographic, and copying personnel and file and records clerks who provide clerical services that are directly necessary for the completion of the professional medical responsibilities and functions of the skilled professional medical staff. The skilled professional medical staff must directly supervise the supporting staff and the performance of the supporting staff's work.
(2)
(e)
(a)
(b)
(2) For part-time training: Travel, per diem, tuition, books and educational supplies.
(3) For State and local Medicaid agency staff development personnel (including supporting staff) assigned fulltime training functions: Salaries, fringe benefits, travel, and per diem. Costs for staff spending less than full time on training for the Medicaid program must be allocated between training and administration in accordance with § 433.34 of this subchapter.
(4) For experts engaged to develop or conduct special programs: Salary, fringe benefits, travel, and per diem.
(5) For agency training activities directly related to the program: Use of space, postage, teaching supplies, and purchase or development of teaching materials and equipment, for example, books and audiovisual aids.
(6) For field instruction in Medicaid: Instructors' salaries and fringe benefits, rental of space, travel, clerical assistance, teaching materials and equipment such as books and audiovisual aids.
(c)
(1) Salaries of supervisors (day-to-day supervision of staff is not a training activity); and
(2) Cost of employing students on a temporary basis, for instance, during summer vacation.
Sec. 1102 of the Social Security Act, (42 U.S.C. 1302).
This part specifies the rates of FFP for services and administration, and prescribes requirements, prohibitions, and FFP conditions relating to State fiscal activities.
(a)
(b)
(c)
(2) Under section 1905(b), the Federal share of State expenditures for services
(3) Under section 1903(g), the FMAP is reduced if the State does not have an effective program to control use of institutional services.
(4) Under section 1905(b) of the Social Security Act, the Federal share of State expenditures described in § 433.11(a) for services provided to children, is the enhanced FMAP rate determined in accordance with § 457.622(b) of this chapter, subject to the conditions explained in § 433.11(b).
(5)(i) Under section 1933(d) of the Act, the Federal share of State expenditures for Medicare Part B premiums described in section 1905(p)(3)(A)(ii) of the Act on behalf of Qualifying Individuals described in section 1902(a)(10)(E)(iv) of the Act, is 100 percent, to the extent that the assistance does not exceed the State's allocation under paragraph (c)(5)(ii) of this section. To the extent that the assistance exceeds that allocation, the Federal share is 0 percent.
(ii) Under section 1933(c)(2) of the Act and subject to paragraph (c)(5)(iii) of this section, the allocation to each State is equal to the total allocation specified in section 1933(g) of the Act multiplied by the Secretary's estimate of the ratio of the total number of individuals described in section 1902(a)(10)(E)(iv) of the Act in the State to the total number of individuals described in section 1902(a)(10)(E)(iv) of the Act for all eligible States. In estimating that ratio, the Secretary will use data from the U.S. Census Bureau.
(iii) If, based on projected expenditures for a fiscal year, or for a shorter period for which funding is available under section 1933 of the Act, the Secretary determines that the expenditures described in paragraph (c)(5)(i) of this section for one or more States are projected to exceed the allocation made to the State, the Secretary may adjust each State's fiscal year allocation, as follows:
(A) The Secretary will compare each State's projected total expenditures for the expenses described in paragraph (c)(5)(i) of this section to the State's initial allocation determined under paragraph (c)(5)(ii) of this section, to determine the extent of each State's projected surplus or deficit.
(B) The surplus of each State with a projected surplus, as determined in accordance with paragraph (c)(5)(iii)(A) of this section will be added together to arrive at the Total Projected Surplus.
(C) The deficit of each State with a projected deficit, as determined in accordance with paragraph (c)(5)(iii)(A) of this section will be added together to arrive at the Total Projected Deficit.
(D) Each State with a projected deficit will receive an additional allocation equal to the amount of its projected deficit, or a prorated amount of such deficit, if the Total Projected Deficit is greater than the Total Projected Surplus. Except as described in paragraph (c)(5)(iii)(E) of this section, the amount to be reallocated from each State with a projected surplus will be equal to A × B, where A equals the Total Projected Deficit and B equals the amount of the State's projected surplus as a percentage of the Total Projected Surplus.
(E) If the Total Projected Deficit determined under paragraph (c)(5)(iii)(C) of this section is greater than the Total Projected Surplus determined under paragraph (c)(5)(iii)(B) of this section, each State with a projected deficit will receive an additional allocation amount equal to the amount of the Total Projected Surplus multiplied by the amount of the projected deficit for such State as a percentage of the Total Projected Deficit. The amount to be reallocated from each State with a projected surplus will be equal to the amount of the projected surplus.
(iv) CMS will notify States of any changes in allotments resulting from any reallocations.
(v) The provisions in paragraph (c)(5) of this section will be in effect through the end of the period for which funding authority is available under section 1933 of the Act.
(a) Subject to the conditions in paragraph (b) of this section, the enhanced FMAP determined in accordance with § 457.622 of this chapter will be used to determine the Federal share of State expenditures, except any expenditures pursuant to section 1923 of the Act for payments to disproportionate share hospitals for—
(1) Services provided to optional targeted low-income children described in § 435.4 or § 436.3 of this chapter; and
(2) Services provided to children born before October 1, 1983, with or without group health coverage or other health insurance coverage, who would be described in section 1902(l)(1)(D) of the Act (poverty-level-related children's groups) if—
(i) They had been born on or after that date; and
(ii) They would not qualify for medical assistance under the State plan in effect on March 31, 1997.
(b) Enhanced FMAP is not available if—
(1) A State adopts income and resource standards and methodologies for purposes of determining a child's eligibility under the Medicaid State plan that are more restrictive than those applied under policies of the State plan (as described in the definition of optional targeted low-income children at § 435.4 of this chapter) in effect on June 1, 1997; or
(2) No funds are available in the State's title XXI allotment, as determined under part 457, subpart F of this chapter for the quarter enhanced FMAP is claimed; or
(3) The State fails to maintain a valid method of identifying services provided on behalf of children listed in paragraph (a) of this section.
(a)
(b)
(2) Administration of family planning services: 90 percent. (Section 1903 (a)(5); 42 CFR 432.50(b)(5).)
(3) Design, development, or installation of mechanized claims processing and information retrieval systems: 90 percent. (Section 1903(a)(3)(A)(i); 42 CFR part 433, subpart C, and § 432.50 (b)(3).)
(4) Operation of mechanized claims processing and information retrieval systems: 75 percent. (Section 1903(a) (3)(B); 42 CFR part 433, subpart C and § 432.50(b)(2).)
(5) Compensation and training of skilled professional medical personnel and staff directly supporting those personnel if the criteria specified in § 432.50 (c) and (d) are met: 75 percent. (Section 1903(a)(2); 42 CFR 432.50(b)(1).)
(6)(i) Funds expended for the performance of medical and utilization review by a QIO under a contract entered into under section 1902(d) of the Act: 75 percent (section 1903(a)(3)(C) of the Act).
(ii) If a State contracts for medical and utilization review with any individual or organization not designated under Part B of Title XI of the Act, funds expended for such review will be reimbursed as provided in paragraph (b)(7) of this section.
(7) All other activities the Secretary finds necessary for proper and efficient administration of the State plan: 50 percent. (Section 1903(a)(7).) (See also § 455.300 of this subchapter for FFP at 90 percent for State Medicaid fraud control units under section 1903(a)(6).)
(8) Nurse aide training and competency evaluation programs and competency evaluation programs described in 1919(e)(1) of the Act: for calendar quarters beginning on or after July 1, 1988 and before July 1, 1990: The lesser of 90% or the Federal medical assistance percentage plus 25 percentage points; for calendar quarters beginning on or after October 1, 1990: 50%. (Section 1903(a)(2)(B) of the Act.)
(9) Preadmission screening and annual resident review (PASARR) activities conducted by the State: 75 percent. (Sections 1903(a)(2)(C) and 1919(e)(7); 42 CFR part 483, subparts C and E.)
(10) Funds expended for the performance of external quality review or the related activities described in § 438.358
A State plan must provide that the Medicaid agency and, where applicable, local agencies administering the plan will—
(a) Maintain an accounting system and supporting fiscal records to assure that claims for Federal funds are in accord with applicable Federal requirements;
(b) Retain records for 3 years from date of submission of a final expenditure report;
(c) Retain records beyond the 3-year period if audit findings have not been resolved; and
(d) Retain records for nonexpendable property acquired under a Federal grant for 3 years from the date of final disposition of that property.
A State plan under Title XIX of the Social Security Act must provide that the single or appropriate Agency will have an approved cost allocation plan on file with the Department in accordance with the requirements contained in subpart E of 45 CFR part 95. Subpart E also sets forth the effect on FFP if the requirements contained in that subpart are not met.
Claims for Federal financial participation in the cost of equipment under the Medicaid Program are determined in accordance with subpart G of 45 CFR part 95. Requirements concerning the management and disposition of equipment under the Medicaid Program are also prescribed in subpart G of 45 CFR part 95.
(a)
(b)
(c)
(d)
(e)
(1) Individual's home.
(2) Equity interest in home.
(3) Residing in the home for at least 1 (or 2) year(s).
(4) On a continuing basis.
(5) Discharge from the medical institution and return home.
(6) Lawfully residing.
(f)
(g)
(2)
(i) An individual is an inpatient of a medical institution and must, as a condition of receiving services in the institution under the State plan, apply his or her income to the cost of care as provided in §§ 435.725, 435.832 and 436.832; and
(ii) The agency determines that he or she cannot reasonably be expected to be discharged and return home. The agency must notify the individual of its intention to make that determination and provide an opportunity for a hearing in accordance with State established procedures before the determination is made. The notice to an individual must include an explanation of liens and the effect on an individual's ownership of property.
(3)
(i) The spouse;
(ii) The individual's child who is under age 21 or blind or disabled as defined in the State plan; or
(iii) The individual's sibling (who has an equity interest in the home, and who was residing in the individual's home for at least one year immediately before the date the individual was admitted to the medical institution).
(4)
(h)
(i) From the estate of any individual who was 65 years of age or older when he or she received Medicaid; and
(ii) From the estate or upon sale of the property subject to a lien when the individual is institutionalized as described in paragraph (g)(2) of this section.
(2) The agency may make an adjustment or recovery under paragraph (h)(1) of this section only:
(i) After the death of the individual's surviving spouse; and
(ii) When the individual has no surviving child under age 21 or blind or disabled as defined in the State plan; and
(iii) In the case of liens placed on an individual's home under paragraph (g)(2) of this section, when there is no—
(A) Sibling of the individual residing in the home, who has resided there for at least one year immediately before the date of the individual's admission to the institution, and has resided there on a continuous basis since that time; or
(B) Son or daughter of the individual residing in the home, who has resided there for at least two years immediately before the date of the individual's admission to the institution, has resided there on a continuous basis since that time, and can establish to the agency's satisfaction that he or she has been providing care which permitted the individual to reside at home rather than in an institution.
(i)
(a)
(1) Identification of providers; and
(2) Compliance with the information reporting requirements of the Internal Revenue Code.
(b)
(1) Social security number if—
(i) The provider is in solo practice; or
(ii) The provider is not in solo practice but billing is by the individual practitioner; or
(2) Employer identification number for all other providers.
(c)
(a)
(1) Claims that have been deferred by the Secretary and disallowed within the time limits of § 430.40 of this chapter. Deferral of claims for FFP; or
(2) Claims for expenditures that have never been paid on a grant award; or
(3) Disallowances of any claims for services furnished before October 1, 1980, regardless of the date of the claim submitted to CMS.
(b)
(i) CMS has notified the Medicaid agency under 45 CFR 74.304 that a State claim for FFP is not allowable;
(ii) The agency has appealed the disallowance to the Grant Appeals Board under 45 CFR Part 16 and has chosen to retain the FFP during the administrative appeals process in accordance with paragraph (c)(2) of this section; and
(iii)(A) The Board has made a final determination upholding part or all of the disallowance; (B) the agency has withdrawn its appeal on all or part of the disallowance; or (C) the agency has reversed its decision to retain the funds without withdrawing its appeal and the Board upholds all or part of the disallowance.
(2) If the courts overturn, in whole or in part, a Board decision that has sustained a disallowance, CMS will return the principal and the interest collected on the funds that were disallowed, upon the completion of all judicial appeals.
(3) Unless an agency decides to withdraw its appeal on part of the disallowance and therefore returns only that part of the funds on which it has withdrawn its appeal, any decision to retain or return disallowed funds must apply to the entire amount in dispute.
(4) If the agency elects to have CMS recover the disputed amount, it may not reverse that election.
(c)
(2) The agency must mail its notice to the CMS Regional Administrator within 30 days of the date of receipt of the notice of the disallowance, as established by the certified mail receipt accompanying the notices.
(3) If the agency withdraws either its decision to retain the FFP or its appeal on all or part of the FFP or both, the agency must notify CMS in writing.
(4) If the agency does not notify the CMS Regional Administrator within the time limit set forth in paragraph (c)(2) of this section. CMS will recover the amount of the disallowed funds
(d)
(2) The interest charge is at the rate CMS determines to be the average of the bond equivalent of the weekly 90-day Treasury bill auction rates during the period for which interest will be charged.
(e)
(i) On the date of the final determination by the Board;
(ii) On the date CMS receives written notice from the State that it is withdrawing its appeal on all of the disallowed funds; or
(iii) If the agency withdraws its appeal on part of the funds, on (A) the date CMS receives written notice from the agency that it is withdrawing its appeal on a specified part of the disallowed funds for the part on which the agency withdraws its appeal; and (B) the date of the final determination by the Board on the part for which the agency pursues its appeal; or
(iv) The date CMS receives written notice from the agency that it no longer chooses to retain the funds.
(2) CMS will not charge interest on FFP retained by an agency for more than 12 months for disallowances of FFP made between October 1, 1980 and August 13, 1981.
(a)
(b)
(c)
(2)
(3) If the State does not refund the appropriate amount as specified in paragraph (c)(2) of this section, the amount will be disallowed.
(d)
(2)
(3) If the State does not refund the appropriate amount as specified in paragraph (d)(2) of this section, the amount will be disallowed.
(a)
(i) A unit of government is a State, a city, a county, a special purpose district, or other governmental unit in the State that: has taxing authority, has direct access to tax revenues, is a State university teaching hospital with direct appropriations from the State treasury, or is an Indian tribe as defined in Section 4 of the Indian Self-Determination and Education Assistance Act, as amended [25 U.S.C. 450b].
(ii) A health care provider may be considered a unit of government only when it is operated by a unit of government as demonstrated by a showing of the following:
(A) The health care provider has generally applicable taxing authority; or
(B) The health care provider has direct access to generally applicable tax revenues. This means the health care provider is able to directly access funding as an integral part of a unit of government with taxing authority which is legally obligated to fund the health care provider's expenses, liabilities, and deficits, so that a contractual arrangement with the State or local government is not the primary or sole basis for the health care provider to receive tax revenues;
(C) The health care provider receives appropriated funding as a State university teaching hospital providing supervised teaching experiences to graduate medical school interns and residents enrolled in a State university in the State; or
(D) The health care provider is an Indian Tribe or Tribal organization (as those terms are defined in Section 4 of the Indian Self-Determination and Education Assistance Act (ISDEAA); 25 U.S.C. 450b) and meets the following criteria:
(
(
(
(2) Section 1903(a) of the Act, which requires the Secretary to pay each State an amount equal to the Federal medical assistance percentage of the total amount expended as medical assistance under the State's plan.
(3) Section 1903(w) of the Act, which specifies the treatment of revenues from provider-related donations and health care-related taxes in determining a State's medical assistance expenditures for which Federal financial participation (FFP) is available under the Medicaid program.
(b)
(1) Specifies State plan requirements for State financial participation in expenditures for medical assistance.
(2) Defines provider-related donations and health care-related taxes that may be received without a reduction in FFP.
(3) Specifies rules for revenues received from provider-related donations
(4) Establishes limitations on FFP when States receive funds from provider-related donations and revenues generated by health care-related taxes.
(c)
(a) Funds from units of government may be considered as the State's share in claiming FFP if they meet the conditions specified in paragraphs (b) and (c) of this section.
(b) The funds from units of government are appropriated directly to the State or local Medicaid agency, or are transferred from other units of government (including Indian tribes) to the State or local agency and are under its administrative control, or are certified by the contributing unit of government as representing expenditures eligible for FFP under this section. Certified public expenditures must be expenditures within the meaning of 45 CFR 95.13 that are supported by auditable documentation in a form approved by the Secretary that, at a minimum—
(1) Identifies the relevant category of expenditures under the State plan;
(2) Explains whether the contributing unit of government is within the scope of the exception to limitations on provider-related taxes and donations;
(3) Demonstrates the actual expenditures incurred by the contributing unit of government in providing services to eligible individuals receiving medical assistance or in administration of the State plan; and
(4) Is subject to periodic State audit and review.
(c) The funds from units of government are not Federal funds, or are Federal funds authorized by Federal law to be used to match other Federal funds.
As used in this subpart—
(1) An organization, association, corporation, or partnership formed by or on behalf of a health care provider;
(2) An individual with an ownership or control interest in the provider, as defined in section 1124(a)(3) of the Act;
(3) An employee, spouse, parent, child, or sibling of the provider, or of a person with an ownership or control interest in the provider, as defined in section 1124(a)(3) of the Act; or
(4) A supplier of health care items or services or a supplier to providers of health care items or services.
(1) Donations made by a health care provider to an organization, which in turn donates money to the State, may be considered to be a donation made indirectly to the State by a health care provider.
(2) When an organization receives less than 25 percent of its revenues from providers and/or provider-related entities, its donations will not generally be presumed to be provider-related donations. Under these circumstances, a provider-related donation to an organization will not be considered a donation made indirectly to the State. However, if the donations from providers to an organization are subsequently determined to be indirect donations to the State or unit of local government for administration of the State's Medicaid program, then such donations will be considered to be health care related.
(3) When the organization receives more than 25 percent of its revenue from donations from providers or provider-related entities, the organization
A State plan must provide that—
(a) State (as distinguished from local) funds will be used both for medical assistance and administration;
(b) State funds will be used to pay at least 40 percent of the non-Federal share of total expenditures under the plan; and
(c) State and Federal funds will be apportioned among the political subdivisions of the State on a basis that assures that—
(1) Individuals in similar circumstances will be treated similarly throughout the State; and
(2) If there is local financial participation, lack of funds from local sources will not result in lowering the amount, duration, scope, or quality of services or level of administration under the plan in any part of the State.
(a) A bona fide donation means a provider-related donation, as defined in § 433.52, made to the State or unit of local government, that has no direct or indirect relationship, as described in paragraph (b) of this section, to Medicaid payments made to—
(1) The health care provider;
(2) Any related entity providing health care items and services; or
(3) Other providers furnishing the same class of items or services as the provider or entity.
(b) Provider-related donations will be determined to have no direct or indirect relationship to Medicaid payments if those donations are not returned to the individual provider, the provider class, or related entity under a hold harmless provision or practice, as described in paragraph (c) of this section.
(c) A hold harmless practice exists if any of the following applies:
(1) The State (or other unit of government) provides for a direct or indirect non-Medicaid payment to those providers or others making, or responsible for, the donation, and the payment amount is positively correlated to the donation. A positive correlation includes any positive relationship between these variables, even if not consistent over time.
(2) All or any portion of the Medicaid payment to the donor, provider class, or related entity, varies based only on the amount of the donation, including where Medicaid payment is conditional on receipt of the donation.
(3) The State (or other unit of government) receiving the donation provides for any direct or indirect payment, offset, or waiver such that the provision of that payment, offset, or waiver directly or indirectly guarantees to return any portion of the donation to the provider (or other parties responsible for the donation).
(d) CMS will presume provider-related donations to be bona fide if the voluntary payments, including, but not limited to, gifts, contributions, presentations or awards, made by or on behalf of individual health care providers to the State, county, or any other unit of local government does not exceed—
(1) $5,000 per year in the case of an individual provider donation; or
(2) $50,000 per year in the case of a donation from any health care organizational entity.
(e) To the extent that a donation presumed to be bona fide contains a hold harmless provision, as described in paragraph (c) of this section, it will not be considered a bona fide donation. When provider-related donations are not bona fide, CMS will deduct this amount from the State's medical assistance expenditures before calculating FFP. This offset will apply to all years the State received such donations and any subsequent fiscal year in which a similar donation is received.
(a) A health care-related tax is a licensing fee, assessment, or other mandatory payment that is related to—
(1) Health care items or services;
(2) The provision of, or the authority to provide, the health care items or services; or
(3) The payment for the health care items or services.
(b) A tax will be considered to be related to health care items or services under paragraph (a)(1) of this section if at least 85 percent of the burden of the tax revenue falls on health care providers.
(c) A tax is considered to be health care related if the tax is not limited to health care items or services, but the treatment of individuals or entities providing or paying for those health care items or services is different than the tax treatment provided to other individuals or entities.
(d) A health care-related tax does not include payment of a criminal or civil fine or penalty, unless the fine or penalty was imposed instead of a tax.
(e) Health care insurance premiums and health maintenance organization premiums paid by an individual or group to ensure coverage or enrollment are not considered to be payments for health care items and services for purposes of determining whether a health care-related tax exists.
(a) For purposes of this subpart, each of the following will be considered as a separate class of health care items or services:
(1) Inpatient hospital services;
(2) Outpatient hospital services;
(3) Nursing facility services (other than services of intermediate care facilities for the mentally retarded);
(4) Intermediate care facility services for the mentally retarded, and similar services furnished by community-based residences for the mentally retarded, under a waiver under section 1915(c) of the Act, in a State in which, as of December 24, 1992, at least 85 percent of such facilities were classified as ICF/MRs prior to the grant of the waiver;
(5) Physician services;
(6) Home health care services;
(7) Outpatient prescription drugs;
(8) Services of managed care organizations (including health maintenance organizations, preferred provider organizations);
(9) Ambulatory surgical center services, as described for purposes of the Medicare program in section 1832(a)(2)(F)(i) of the Social Security Act. These services are defined to include facility services only and do not include surgical procedures;
(10) Dental services;
(11) Podiatric services;
(12) Chiropractic services;
(13) Optometric/optician services;
(14) Psychological services;
(15) Therapist services, defined to include physical therapy, speech therapy, occupational therapy, respiratory therapy, audiological services, and rehabilitative specialist services;
(16) Nursing services, defined to include all nursing services, including services of nurse midwives, nurse practitioners, and private duty nurses;
(17) Laboratory and x-ray services, defined as services provided in a licensed, free-standing laboratory or x-ray facility. This definition does not include laboratory or x-ray services provided in a physician's office, hospital inpatient department, or hospital outpatient department;
(18) Emergency ambulance services; and
(19) Other health care items or services not listed above on which the State has enacted a licensing or certification fee, subject to the following:
(i) The fee must be broad based and uniform or the State must receive a waiver of these requirements;
(ii) The payer of the fee cannot be held harmless; and
(iii) The aggregate amount of the fee cannot exceed the State's estimated cost of operating the licensing or certification program.
(b) Taxes that pertain to each class must apply to all items and services within the class, regardless of whether the items and services are furnished by or through a Medicaid-certified or licensed provider.
Effective January 1, 1992, CMS will deduct from a State's expenditures for medical assistance, before calculating FFP, funds from provider-related donations and revenues generated by health care-related taxes received by a State or unit of local government, in accordance with the requirements, conditions, and limitations of this subpart, if the donations and taxes are not—
(a) Permissible provider-related donations, as specified in § 433.66(b); or
(b) Health care-related taxes, as specified in § 433.68(b).
(a)
(2) The provisions of this section relating to provider-related donations for outstationed eligibility workers are effective on October 1, 1992.
(b)
(1) The donations must be bona fide donations, as defined in § 433.54; or
(2) The donations are made by a hospital, clinic, or similar entity (such as a Federally-qualified health center) for the direct costs of State or local agency personnel who are stationed at the facility to determine the eligibility (including eligibility redeterminations) of individuals for Medicaid or to provide outreach services to eligible (or potentially eligible) Medicaid individuals. Direct costs of outstationed eligibility workers refers to the costs of training, salaries and fringe benefits associated with each outstationed worker and similar allocated costs of State or local agency support staff, and a prorated cost of outreach activities applicable to the outstationed workers at these sites. The prorated costs of outreach activities will be calculated taking the percent of State outstationed eligibility workers at a facility to total outstationed eligibility workers in the State, and multiplying the percent by the total cost of outreach activities in the State. Costs for such items as State agency overhead and provider office space are not allowable for this purpose.
(a)(1)
(2)
(b)
(a)
(b)
(1) The taxes are broad based, as specified in paragraph (c) of this section;
(2) The taxes are uniformly imposed throughout a jurisdiction, as specified in paragraph (d) of this section; and
(3) The tax program does not violate the hold harmless provisions specified in paragraph (f) of this section.
(c)
(2) If a health care-related tax is imposed by a unit of local government, the tax must extend to all items or services or providers (or to all providers in a class) in the area over which the unit of government has jurisdiction.
(3) A State may request a waiver from CMS of the requirement that a tax program be broad based, in accordance with the procedures specified in § 433.72. Waivers from the uniform and broad-based requirements will automatically be granted in cases of variations in licensing and certification fees for providers if the amount of such fees is not more than $1,000 annually per provider and the total amount raised by the State from the fees is used in the administration of the licensing or certification program.
(d)
(1) A health care-related tax will be considered to be imposed uniformly if it meets any one of the following criteria:
(i) If the tax is a licensing fee or similar tax imposed on a class of health care services (or providers of those health care items or services), the tax is the same amount for every provider furnishing those items or services within the class.
(ii) If the tax is a licensing fee or similar tax imposed on a class of health care items or services (or providers of those items or services) on the basis of the number of beds (licensed or otherwise) of the provider, the amount of the tax is the same for each bed of each provider of those items or services in the class.
(iii) If the tax is imposed on provider revenue or receipts with respect to a class of items or services (or providers of those health care items or services), the tax is imposed at a uniform rate for all services (or providers of those items or services) in the class on all the gross revenues or receipts, or on net operating revenues relating to the provision of all items or services in the State, unit, or jurisdiction. Net operating revenue means gross charges of facilities less any deducted amounts for bad debts, charity care, and payer discounts.
(iv) The tax is imposed on items or services on a basis other than those specified in paragraphs (d)(1) (i) through (iii) of this section, e.g., an admission tax, and the State establishes to the satisfaction of the Secretary that the amount of the tax is the same for each provider of such items or services in the class.
(2) A tax imposed with respect to a class of health care items or services will not be considered to be imposed uniformly if it meets either one of the following two criteria:
(i) The tax provides for credits, exclusions, or deductions which have as
(A) The net impact of the tax and payments is not generally redistributive, as specified in paragraph (e) of this section; and
(B) The amount of the tax is directly correlated to payments under the Medicaid program.
(ii) The tax holds taxpayers harmless for the cost of the tax, as described in paragraph (f) of this section.
(3) If a tax does not meet the criteria specified in paragraphs (d)(1)(i) through (iv) of this section, but the State establishes that the tax is imposed uniformly in accordance with the procedures for a waiver specified in § 433.72, the tax will be treated as a uniform tax.
(e)
(1)
(i) A State seeking waiver of the broad-based tax requirement only must demonstrate that its proposed tax plan meets the requirement that its plan is generally redistributive by:
(A) Calculating the proportion of the tax revenue applicable to Medicaid if the tax were broad based and applied to all providers or activities within the class (called P1);
(B) Calculating the proportion of the tax revenue applicable to Medicaid under the tax program for which the State seeks a waiver (called P2); and
(C) Calculating the value of P1/P2.
(ii) If the State demonstrates to the Secretary's satisfaction that the value of P1/P2 is at least 1, CMS will automatically approve the waiver request.
(iii) If a tax is enacted and in effect prior to August 13, 1993, and the State demonstrates to the Secretary's satisfaction that the value of P1/P2 is at least 0.90, CMS will review the waiver request. Such a waiver will be approved only if the following two criteria are met:
(A) The value of P1/P2 is at least 0.90; and
(B) The tax excludes or provides credits or deductions only to one or more of the following providers of items and services within the class to be taxed:
(
(
(
(
(
(
(
(
(
(
(
(iv) If a tax is enacted and in effect after August 13, 1993, and the State demonstrates to the Secretary's satisfaction that the value of P1/P2 is at least 0.95, CMS will review the waiver request. Such a waiver request will be
(A) The value of P1/P2 is at least 0.95; and
(B) The tax complies with the provisions of § 433.68(e)(1)(iii)(B).
(2)
(i) A State seeking waiver of the uniform tax requirement (whether or not the tax is broad based) must demonstrate that its proposed tax plan meets the requirement that its plan is generally redistributive by:
(A) Calculating, using ordinary least squares, the slope (designated as (
(B) Calculating the slope (designated as B1) of the linear regression, as described in paragraph (e)(2)(i) of this section, for the State's tax program, if it were broad based and uniform.
(C) Calculating the slope (designated as B2) of the linear regression, as described in paragraph (e)(2)(i) of this section, for the State's tax program, as proposed.
(ii) If the State demonstrates to the Secretary's satisfaction that the value of B1/B2 is at least 1, CMS will automatically approve the waiver request.
(iii) If the State demonstrates to the Secretary's satisfaction that the value of B1/B2 is at least 0.95, CMS will review the waiver request. Such a waiver will be approved only if the following two criteria are met:
(A) The value of B1/B2 is at least 0.95; and
(B) The tax excludes or provides credits or deductions only to one or more of the following providers of items and services within the class to be taxes:
(
(
(
(
(
(
(
(
(
(
(
(iv) A B1/B2 value of 0.70 will be applied to taxes that vary based exclusively on regional variations, and enacted and in effect prior to November 24, 1992, to permit such variations.
(f)
(1) The State (or other unit of government) imposing the tax provides for a direct or indirect non-Medicaid payment to those providers or others paying the tax and the payment amount is
(2) All or any portion of the Medicaid payment to the taxpayer varies based only on the tax amount, including where Medicaid payment is conditional on receipt of the tax amount.
(3) The State (or other unit of government) imposing the tax provides for any direct or indirect payment, offset, or waiver such that the provision of that payment, offset, or waiver directly or indirectly guarantees to hold taxpayers harmless for all or any portion of the tax amount.
(i)(A) An indirect guarantee will be determined to exist under a two prong “guarantee” test. If the health care-related tax or taxes on each health care class are applied at a rate that produces revenues less than or equal to 6 percent of the revenues received by the taxpayer, the tax or taxes are permissible under this test. The phrase “revenues received by the taxpayer” refers to the net patient revenue attributable to the assessed permissible class of health care items or services. However, for the period of January 1, 2008 through September 30, 2011, the applicable percentage of net patient service revenue is 5.5 percent. Compliance in State fiscal year 2008 will be evaluated from January 1, 2008 through the last day of State fiscal year 2008. Beginning with State fiscal year 2009 the 5.5 percent tax collection will be measured on an annual State fiscal year basis.
(B) When the tax or taxes produce revenues in excess of the applicable percentage of the revenue received by the taxpayer, CMS will consider an indirect hold harmless provision to exist if 75 percent or more of the taxpayers in the class receive 75 percent or more of their total tax costs back in enhanced Medicaid payments or other State payments. The second prong of the indirect hold harmless test is applied in the aggregate to all health care taxes applied to each class. If this standard is violated, the amount of tax revenue to be offset from medical assistance expenditures is the total amount of the taxpayers' revenues received by the State.
(ii) [Reserved]
(a)
(b)
(a)
(i) The tax does not meet the broad based criteria specified in § 433.68c); and/or
(ii) The tax is not imposed uniformly but meets the criteria specified in § 433.68(d)(2) or (d)(3).
(2) When a tax that meets the criteria specified in paragraph (a)(1) of this section is imposed on more than one class of health care items or services, a separate waiver must be obtained for each class of health care items and services subject to the tax.
(b)
(1) The net impact of the tax and any payments made to the provider by the
(2) The amount of the tax is not directly correlated to Medicaid payments; and
(3) The tax program does not fall within the hold harmless provisions specified in § 433.68(f).
(c)
(1) The date of enactment of the tax for programs in existence prior to August 13, 1993 or;
(2) For tax programs commencing on or after August 13, 1993, on the first day in the quarter in which the waiver is received by CMS.
(a) Beginning with the first quarter of Federal fiscal year 1993, each State must submit to CMS quarterly summary information on the source and use of all provider-related donations (including all bona fide and presumed-to-be bona fide donations) received by the State or unit of local government, and health care-related taxes collected. Each State must also provide any additional information requested by the Secretary related to any other donations made by, or any taxes imposed on, health care providers. States' reports must present a complete, accurate, and full disclosure of all of their donation and tax programs and expenditures.
(b) Each State must provide the summary information specified in paragraph (a) of this section on a quarterly basis in accordance with procedures established by CMS.
(c) Each State must maintain, in readily reviewable form, supporting documentation that provides a detailed description and legal basis for each donation and tax program being reported, as well as the source and use of all donations received and taxes collected. This information must be made available to Federal reviewers upon request.
(d) If a State fails to comply with the reporting requirements contained in this section, future grant awards will be reduced by the amount of FFP CMS estimates is attributable to the sums raised by tax and donation programs as to which the State has not reported properly, until such time as the State complies with the reporting requirements. Deferrals and/or disallowances of equivalent amounts may also be imposed with respect to quarters for which the State has failed to report properly. Unless otherwise prohibited by law, FFP for those expenditures will be released when the State complies with all reporting requirements.
(a) This subpart implements the following sections of the Act:
(1) Section 1903(a)(3) of the Act, which provides for FFP in State expenditures for the design, development, or installation of mechanized claims processing and information retrieval systems and for the operation of certain systems. Additional HHS regulations and CMS procedures for implementing these regulations are in 45 CFR part 74, 45 CFR part 95, subpart F, and part 11, State Medicaid Manual; and
(2) Section 1903(r) of the Act, which—(i) Requires reductions in FFP otherwise due a State under section 1903(a) if a State fails to meet certain deadlines for operating a mechanized claims processing and information retrieval system or if the system fails to meet certain conditions of approval or conditions of reapproval;
(ii) Requires a Federal performance review at least every three years of the mechanized claims processing and information retrieval systems; and
(iii) Allows waivers of conditions of approval, conditions of reapproval, and FFP reductions under certain circumstances.
(b) The requirements under section 1903(r) of the Act do not apply to Puerto Rico, Guam, the Virgin Islands, American Samoa and the Northern Mariana Islands.
For purposes of this section:
(a) The following terms are defined at 45 CFR part 95, subpart F § 95.605:
(b) “Mechanized claims processing and information retrieval system” or “system” means the system of software and hardware used to process Medicaid claims from providers of medical care and services for the medical care and services furnished to recipients under the medical assistance program and to retrieve and produce service utilization and management information required by the Medicaid single State agency and Federal Government for program administration and audit purposes. The system consists of
(1) Required subsystems specified in the State Medicaid Manual;
(2) Required changes to the required system or subsystem that are published in accordance with § 433.123 of this subpart and specified in the State Medicaid Manual; and
(3) Approved enhancements to the system. Eligibility determination systems are not part of mechanized claims processing and information retrieval systems or enhancements to those systems.
(a) FFP is available at the 90 percent rate in State expenditures for the design, development, installation, or enhancement of a mechanized claims processing and information retrieval system only if the APD is approved by CMS prior to the State's expenditure of funds for these purposes.
(b) CMS will approve the system described in the APD if the following conditions are met:
(1) CMS determines the system is likely to provide more efficient, economical, and effective administration of the State plan.
(2) The system meets the system requirements and performance standards in Part 11 of the State Medicaid Manual, as periodically amended.
(3) The system is compatible with the claims processing and information retrieval systems used in the administration of Medicare for prompt eligibility verification and for processing claims for persons eligible for both programs.
(4) The system supports the data requirements of quality improvement organizations established under Part B of title XI of the Act.
(5) The State owns any software that is designed, developed, installed or improved with 90 percent FFP.
(6) The Department has a royalty free, non-exclusive, and irrevocable license to reproduce, publish, or otherwise use and authorize others to use, for Federal Government purposes, software, modifications to software, and documentation that is designed, developed, installed or enhanced with 90 percent FFP.
(7) The costs of the system are determined in accordance with 45 CFR 74.171.
(8) The Medicaid agency agrees in writing to use the system for the period of time specified in the advance planning document approved by CMS or for any shorter period of time that CMS determines justifies the Federal funds invested.
(9) The agency agrees in writing that the information in the system will be safeguarded in accordance with subpart F, part 431 of this subchapter.
(c) Eligibility determination systems are not part of mechanized claims processing and information retrieval systems and are not eligible for 75 percent FFP under this subpart. These systems are also not eligible for 90 percent FFP for any APD approved after November 13, 1989.
(a) Except as waived under § 433.130 or 433.131, FFP will be reduced as specified
(1) The APD for the system was approved by CMS;
(2) The system is operational by September 30, 1985; and
(3) The system is initially approved by the last day of the fourth quarter that begins after the date the system became operational as determined by CMS.
(b) CMS will reduce FFP in expenditures for compensation and training of skilled professional medical personnel and support staff under section 1903(a)(2) of the Act, and for general administration under section 1903(a)(7) of the Act, by the following increments applied separately to those two categories of expenditures:
(1) Five percentage points for the first two quarters beginning after a deadline in paragraph (a) of this section;
(2) An additional five percentage points during each additional two-quarter period, through the quarter in which the State achieves compliance with the conditions for initial operation or initial approval of an operating system. FFP reductions will not exceed 25 percentage points for each type of reduction.
(c) The amount of FFP (determined under section 1903(a)(3)(B)) that would be available retroactively for operating a system that later receives initial approval will be reduced by CMS by the same percentage points for the identical periods of time described in subparagraph (b)(1) of this section, until the system is initially approved. No reduction will be made after the first quarter during which the system is initially approved.
(a) To obtain initial approval, the Medicaid agency must inform CMS in writing that the system meets the conditions specified in § 433.116(c) through (h).
(b) If CMS disapproves the system, or determines that the system met requirements for initial approval on a date later than the date required under § 433.113(a)(3), the notice will include—
(1) The findings of fact upon which the determination was made; and
(2) The procedures for appeal of the determination in the context of a reconsideration of the resulting disallowance, to the Departmental Appeals Board.
(a) Subject to 42 CFR 433.113(c), FFP is available at 75 percent of expenditures for operation of a mechanized claims processing and information retrieval system approved by CMS, from the first day of the calendar quarter after the date the system met the conditions of initial approval, as established by CMS (including a retroactive adjustment of FFP if necessary to provide the 75 percent rate beginning on the first day of that calendar quarter). Subject to 45 CFR 95.611(a), the State shall obtain prior written approval from CMS when it plans to acquire ADP equipment or services, when it anticipates the total acquisition costs will exceed thresholds, and meets other conditions of the subpart.
(b) CMS will approve the system operation if the conditions specified in paragraphs (c) through (h) of this section are met.
(c) The conditions of § 433.112(b) (1) through (4) and (7) through (9), as periodically modified under § 433.112(b)(2), must be met.
(d) The system must have been operating continuously during the period for which FFP is claimed.
(e) The system must provide individual notices, within 45 days of the payment of claims, to all or a sample group of the persons who received services under the plan.
(f) The notice required by paragraph (e) of this section—
(1) Must specify—
(i) The service furnished;
(ii) The name of the provider furnishing the service;
(iii) The date on which the service was furnished; and
(iv) The amount of the payment made under the plan for the service; and
(2) Must not specify confidential services (as defined by the State) and must not be sent if the only service furnished was confidential.
(g) The system must provide both patient and provider profiles for program management and utilization review purposes.
(h) If the State has a Medicaid fraud control unit certified under section 1903(q) of the Act and § 455.300 of this chapter, the Medicaid agency must have procedures to assure that information on probable fraud or abuse that is obtained from, or developed by, the system is made available to that unit. (See § 455.21 of this chapter for State plan requirements.)
(a) A replacement system must meet all conditions of initial approval of a mechanized claims processing and information retrieval system.
(b) The agency must submit a APD that includes—
(1) The date the replacement system will be in operation; and
(2) A plan for orderly transition from the system being replaced to the replacement system.
(c) FFP is available at—
(1) 90 percent in expenditures for design, development, and installation in accordance with the provisions of § 433.112; and
(2) 75 percent in expenditures for operation of an approved replacement system in accordance with the provisions of § 433.116(b) through (h), from the date that the system met the conditions of initial approval, as established by CMS.
(d) FFP is available at 75 percent in expenditures for the operation of an approved system that is being replaced (or at a reduced rate determined under § 433.120 of this subpart for a system that has been disapproved) until the replacement system is in operation and approved.
(a) CMS will review at least once every three years each system operation initially approved under § 433.114 and reapprove it for FFP at 75 percent of expenditures if the following conditions are met:
(1) The system meets the conditions of § 433.112(b) (1), (3), (4), and (7) through (9).
(2) The system meets the conditions of § 433.116 (d) through (h).
(3) The system meets the performance standards for reapproval and the system requirements in part 11 of the State Medicaid Manual as periodically amended.
(4) Automated eligibility determination systems approved or operating on or before November 13, 1989, will not qualify for FFP at 75 percent of expenditures after November 13, 1989.
(b) CMS may review an entire system operation or focus its review on parts of the operation. However, at a minimum, CMS will review standards, system requirements and other conditions of reapproval that have demonstrated weakness in a previous review or reviews.
(c) CMS will issue to each Medicaid agency, by the end of the first quarter after the review period, a written notice informing the agency whether its system is reapproved or disapproved. If the system is disapproved, the notice will also include—
(1) CMS's decision to reduce FFP for system operations, and the percentage to which it is reduced, beginning with the next calender quarter;
(2) The findings of fact upon which the determination was made; and
(3) A statement that State claims in excess of the reduced FFP rate will be disallowed and that any such disallowance will be appealable to the Departmental Appeals Board.
(a) If CMS determines after the reapproval review that the system no longer meets the conditions of reapproval in § 433.119, CMS will reduce FFP for system operations for at least four quarters. However, no system will be subject to reduction of FFP for at least the first four quarters after the quarter in which the system is initially approved as eligible for 75 percent FFP.
(b) CMS will reduce FFP in expenditures for system operations from 75 percent to no more than 70 percent and no less than 50 percent; however, CMS will not reduce FFP by more than 10 percentage points in any four-quarter period. The percentage to which the FFP is reduced will depend primarily on the following criteria:
(1) The number of conditions judged unsatisfactory;
(2) The extent to which conditions were not met;
(3) The significance of the unsatisfactory conditions in overall mechanized claims processing and information retrieval system operations; and
(4) The actual and potential program impact attributable to the unsatisfactory conditions.
(a) The agency may appeal to the Departmental Appeals Board under 45 CFR part 16, a disallowance concerning a reduction in FFP claimed for system operation caused by a disapproval of the State's system. If the Board finds such a disallowance to be appropriate, the discretionary determination to reduce FFP by a particular percentage amount (instead of by a lesser percentage) is not subject to review by the Board unless the percentage reduction exceeds the range authorized by section 1903(r)(4)(B) of the Act.
(b) The decisions concerning whether to restore any FFP retroactively and the actual number of quarters for which FFP will be restored under § 433.122 of this subpart are not subject to administrative appeal to the Departmental Appeals Board under 45 CFR part 16.
(c) An agency's request for a reconsideration before the Board under paragraph (a) of this section does not delay implementation of the reduction in FFP. However, any reduction is subject to retroactive adjustment if required by the Board's determination on reconsideration.
When FFP has been reduced under § 433.120(a), and CMS determines upon subsequent review that the system meets all current performance standards, system requirements and other conditions of reapproval, the following provisions apply:
(a) CMS will resume FFP in expenditures for system operations at the 75 percent level beginning with the quarter following the review determination that the system again meets conditions of reapproval.
(b) CMS may retroactively waive a reduction of FFP in expenditures for system operations if CMS determines that the waiver could improve the administration of the State Medicaid plan. However, CMS cannot waive this reduction for any quarter before the fourth quarter immediately preceding the quarter in which CMS issues the determination (as part of the review process) stating that the system is reapproved.
(a) Whenever CMS modifies system requirements or other conditions for approval under § 433.112 or § 433.116, CMS will—
(1) Publish a notice in the
(2) Respond in a subsequent
(3) Issue the new or modified requirements or conditions in the State Medicaid Manual.
(b) For changes in system requirements or other conditions for approval, CMS will allow an appropriate period for Medicaid agencies to meet the requirement determining this period on the basis of the requirement's complexity and other relevant factors.
(c) Whenever CMS modifies performance standards and other conditions for reapproval under § 433.119, CMS will notify Medicaid agencies at least one calendar quarter before the review period to which the new or modified standards or conditions apply.
CMS will terminate FFP at any time if the Medicaid agency fails to provide State and Federal representatives with full access to the system, including on-site inspection. CMS may request such access at any time to determine whether the conditions in this subpart are being met.
(a) CMS will waive requirements for initial operation and approval of systems under § 433.113 for a State meeting the requirements of paragraph (b) of this section and that had a 1976 population of less than one million and made total Federal and State Medicaid expenditures of less than $100 million in fiscal year 1976. Population figures are those reported by the Bureau of the Census. Expenditures for fiscal year 1976 are those reported by the State for that year.
(b) To be eligible for this waiver, the agency must submit its reasons to CMS in writing and demonstrate to CMS's satisfaction that a system will not significantly improve the efficiency of the administration of the State plan.
(c) If CMS denies the waiver request, the notice of denial will include—
(1) The findings of fact upon which the denial was made; and
(2) The procedures for appeal of the denial.
(d) If CMS determines, after granting a waiver, that a system would significantly improve the administration of the State Medicaid program, CMS may withdraw the waiver and require that a State obtain initial approval of a system within two years of the date of waiver withdrawal.
If a State is unable to comply with the conditions of approval or of reapproval and the noncompliance will cause a percentum reduction in FFP, CMS will waive the FFP reduction in the following circumstances:
(a)
(b)
This subpart implements sections 1902(a)(25), 1902(a)(45), 1903(d)(2), 1903(o), 1903(p), and 1912 of the Act by setting forth State plan requirements concerning—
(a) The legal liability of third parties to pay for services provided under the plan;
(b) Assignment to the State of an individual's rights to third party payments; and
(c) Cooperative agreements between the Medicaid agency and other entities for obtaining third party payments.
For purposes of this subpart—
(1) Any commercial insurance company offering health or casualty insurance to individuals or groups (including both experience-rated insurance contracts and indemnity contracts);
(2) Any profit or nonprofit prepaid plan offering either medical services or full or partial payment for services included in the State plan; and
(3) Any organization administering health or casualty insurance plans for professional associations, unions, fraternal groups, employer-employee benefit plans, and any similar organization offering these payments or services, including self-insured and self-funded plans.
(a) A State plan must provide that the requirements of §§ 433.138 and 433.139 are met for identifying third parties liable for payment of services under the plan and for payment of claims involving third parties.
(b) A State plan must provide that—
(1) The requirements of §§ 433.145 through 433.148 are met for assignment of rights to benefits, cooperation with the agency in obtaining medical support or payments, and cooperation in identifying and providing information to assist the State in pursuing any liable third parties; and
(2) The requirements of §§ 433.151 through 433.154 are met for cooperative agreements and incentive payments for third party collections.
(c) The requirements of paragraph (b)(1) of this section relating to assignment of rights to benefits and cooperation in obtaining medical support or payments and paragraph (b)(2) of this section are effective for medical assistance furnished on or after October 1, 1984. The requirements of paragraph (b)(1) of this section relating to cooperation in identifying and providing information to assist the State in pursuing liable third parties are effective for medical assistance furnished on or after July 1, 1986.
(a)
(b)
(2) If Medicaid eligibility is determined by the Federal agency administering the supplemental security income program under title XVI in accordance with a written agreement under section 1634 of the Act, the Medicaid agency must take the following action. It must enter into an agreement with CMS or must have, prior to February 1, 1985, executed a modified section 1634 agreement that is still in effect to provide for—
(i) Collection, from the applicant or recipient during the initial application and each redetermination process, of health insurance information in the form and manner specified by the Secretary; and
(ii) Transmittal of the information to the Medicaid agency.
(3) If Medicaid eligibility is determined by any other agency in accordance with a written agreement, the Medicaid agency must modify the agreement to provide for—
(i) Collection, from the applicant or recipient during the initial application and each redetermination process, of such health insurance information as would be useful in identifying legally liable third party resources so that the Medicaid agency may process claims under the third party liability payment procedures specified in § 433.139 (b) through (f). Health insurance information may include, but is not limited to, those elements described in paragraph (b)(1) of this section; and
(ii) Transmittal of the information to the Medicaid agency.
(c)
(d)
(1) Except as specified in paragraph (d)(2) of this section, as part of the data exchange requirements under § 435.945 of this chapter, from the State wage information collection agency (SWICA) defined in § 435.4 of this chapter and from the SSA wage and earnings files data as specified in § 435.948(a)(2) of this chapter, the agency must—
(i) Use the information that identifies Medicaid recipients that are employed and their employer(s); and
(ii) Obtain and use, if their names and SSNs are available to the agency under paragraph (c) of this section, information that identifies employed absent or custodial parents of recipients and their employer(s).
(2) If the agency can demonstrate to CMS that it has an alternate source of information that furnishes information as timely, complete and useful as the SWICA and SSA wage and earnings files in determining the legal liability of third parties, the requirements of paragraph (d)(1) of this section are deemed to be met.
(3) The agency must request, as required under § 435.948(a)(6)(i), from the State title IV-A agency, information not previously reported that identifies those Medicaid recipients that are employed and their employer(s).
(4) Except as specified in paragraph (d)(5) of this section, the agency must attempt to secure agreements (to the extent permitted by State law) to provide for obtaining—
(i) From State Workers' Compensation or Industrial Accident Commission files, information that identifies Medicaid recipients and, (if their names and SSNs were available to the agency under paragraph (c) of this section) absent or custodial parents of Medicaid recipients with employment-related injuries or illnesses; and
(ii) From State Motor Vehicle accident report files, information that identifies those Medicaid recipients injured in motor vehicle accidents, whether injured as pedestrians, drivers, passengers, or bicyclists.
(5) If unable to secure agreements as specified in paragraph (d)(4) of this section, the agency must submit documentation to the regional office that
(e)
(2) The agency may exclude code 994.6, Motion Sickness, from the edits required under paragraph (e)(1) of this section.
(f)
(g)
(1)
(i) Except as specified in § 435.952(d) of this chapter, within 45 days, the agency must followup (if appropriate) on such information in order to identify legally liable third party resources and incorporate such information into the eligibility case file and into its third party data base and third party recovery unit so the agency may process claims under the third party liability payment procedures specified in § 433.139 (b) through (f); and
(ii) The State plan must describe the methods the agency uses for meeting the requirements of paragraph (g)(1)(i) of this section.
(2)
(i) Within 60 days, the agency must followup on such information (if appropriate) in order to identify legally liable third party resources and incorporate such information into the eligibility case file and into its third party data base and third party recovery unit so the agency may process claims under the third party liability payment procedures specified in § 433.139 (b) through (f); and
(ii) The State plan must describe the methods the agency uses for meeting the requirements of paragraph (g)(2)(i) of this section.
(3)
(i) The State plan must describe the methods the agency uses for following up on such information in order to identify legally liable third party resources so the agency may process claims under the third party liability payment procedures specified in § 433.139 (b) through (f);
(ii) After followup, the agency must incorporate all information that identifies legally liable third party resources into the eligibility case file and into its third party data base and third party recovery unit; and
(iii) The State plan must specify timeframes for incorporation of the information.
(4)
(i) The State plan must describe the methods the agency uses to follow up on such claims in order to identify legally liable third party resources so the agency may process claims under the third party liability payment procedures specified in § 433.139 (b) through (f) (Methods must include a procedure
(ii) After followup, the agency must incorporate all information that identifies legally liable third party resources into the eligibility case file and into its third party data base and third party recovery unit; and
(iii) The State plan must specify the timeframes for incorporation of the information.
(h)
(2) Before requesting information from, or releasing information to other agencies to identify legally liable third party resources under paragraph (d) of this section the agency must execute data exchange agreements with those agencies. The agreements, at a minimum, must specify—
(i) The information to be exchanged;
(ii) The titles of all agency officials with the authority to request third party information;
(iii) The methods, including the formats to be used, and the timing for requesting and providing the information;
(iv) The safeguards limiting the use and disclosure of the information as required by Federal or State law or regulations; and
(v) The method the agency will use to reimburse reasonable costs of furnishing the information if payment is requested.
(i)
(j)
(k)
(2) The action plan must describe the actions and methodologies the State will follow to—
(i) Identify third parties;
(ii) Determine the liability of third parties;
(iii) Avoid payment of third party claims as required in § 433.139;
(iv) Recover reimbursement from third parties after Medicaid claims payment as required in § 433.139; and,
(v) Record information and actions relating to the action plan.
(3) The action plan must be consistent with the conditions for reapproval set forth in § 433.119. The portion of the plan which is integrated with MMIS is monitored in accordance with those conditions and if the conditions are not met; it is subject to FFP reduction in accordance with procedures set forth in § 433.120. The State is not subject to any other penalty as a result of other monitoring, quality control, or auditing requirements for those items in the action plan.
(4) The agency must submit its action plan to the CMS Regional Office within 120 days from the date CMS issues implementing instructions for the State Medicaid Manual. If a State does not have an approved MMIS on the date of issuance of the State Medicaid Manual but subsequently implements an MMIS, the State must submit its action plan within 90 days from the date the system is operational. The CMS Regional Office approves or disapproves the action plan.
(l)
(i) The agency must submit a request for waiver of the requirement in writing to the CMS regional office.
(ii) The request must contain adequate documentation to establish that to meet a requirement specified by the agency is not cost-effective. Examples of documentation are claims recovery data and a State analysis documenting a cost-effective alternative that accomplished the same task.
(iii) The agency must agree, if a waiver is granted, to notify CMS of any event that occurs that changes the conditions upon which the waiver was approved.
(2) CMS will review a State's request to have a requirement specified under paragraph (l)(1) of this section waived and will request additional information from the State, if necessary. CMS will notify the State of its approval or disapproval determination within 30 days of receipt of a properly documented request.
(3) CMS may rescind a waiver at any time that it determines that the agency no longer meets the criteria for approving the waiver. If the waiver is rescinded, the agency has 6 months from the date of the rescission notice to meet the requirement that had been waived.
(a)
(2) The agency must submit documentation of the methods (e.g., cost avoidance, pay and recover later) it uses for payment of claims involving third party liability to the CMS Regional Office.
(b)
(1) If the agency has established the probable existence of third party liability at the time the claim is filed, the agency must reject the claim and return it to the provider for a determination of the amount of liability. The establishment of third party liability takes place when the agency receives confirmation from the provider or a third party resource indicating the extent of third party liability. When the amount of liability is determined, the agency must then pay the claim to the extent that payment allowed under the agency's payment schedule exceeds the amount of the third party's payment.
(2) The agency may pay the full amount allowed under the agency's payment schedule for the claim and then seek reimbursement from any liable third party to the limit of legal liability if the claim is for labor and delivery and postpartum care. (Costs associated with the inpatient hospital stay for labor and delivery and postpartum care must be cost-avoided.)
(3) The agency must pay the full amount allowed under the agency's payment schedule for the claim and seek reimbursement from any liable third party to the limit of legal liability (and for purposes of paragraph (b)(3)(ii) of this section, from a third party, if the third party liability is derived from an absent parent whose obligation to pay support is being enforced by the State title IV-D agency), consistent with paragraph (f) of this section if—
(i) The claim is prenatal care for pregnant women, or preventive pediatric services (including early and periodic screening, diagnosis and treatment services provided for under part 441, subpart B of this chapter), that is covered under the State plan; or
(ii) The claim is for a service covered under the State plan that is provided
(A) The State plan specifies whether or not providers are required to bill the third party.
(B) The provider certifies that before billing Medicaid, if the provider has billed a third party, the provider has waited 30 days from the date of the service and has not received payment from the third party.
(C) The State plan specifies the method used in determining the provider's compliance with the billing requirements.
(c)
(d)
(2) Except as provided in paragraph (e) of this section, if the agency learns of the existence of a liable third party after a claim is paid, or benefits become available from a third party after a claim is paid, the agency must seek recovery of reimbursement within 60 days after the end of the month it learns of the existence of the liable third party or benefits become available.
(3) Reimbursement must be sought unless the agency determines that recovery would not be cost effective in accordance with paragraph (f) of this section.
(e)
(i) The agency must submit a request for waiver of the requirement in writing to the CMS regional office.
(ii) The request must contain adequate documentation to establish that to meet a requirement specified by the agency is not cost-effective. Examples of documentation are costs associated with billing, claims recovery data, and a State analysis documenting a cost-effective alternative that accomplishes the same task.
(iii) The agency must agree, if a waiver is granted, to notify CMS of any event that occurs that changes the conditions upon which the waiver was approved.
(2) CMS will review a State's request to have a requirement specified under paragraph (e)(1) of this section waived and will request additional information from the State, if necessary. CMS will notify the State of its approval or disapproval determination within 30 days of receipt of a properly documented request.
(3) CMS may rescind the waiver at any time that it determines that the State no longer meets the criteria for approving the waiver. If the waiver is rescinded, the agency has 6 months from the date of the rescission notice to meet the requirement that had been waived.
(4) An agency requesting a waiver of the requirements specifically concerning either the 60-day limit in paragraph (d)(1) or (d)(2) of this section must submit documentation of written agreement between the agency and the third party, including Medicare fiscal intermediaries and carriers, that extension of the billing requirement is agreeable to all parties.
(f)
(2) The State plan must specify the threshold amount or other guideline that the agency uses in determining whether to seek recovery of reimbursement from a liable third party, or describe the process by which the agency determines that seeking recovery of reimbursement would not be cost effective.
(3) The State plan must also specify the dollar amount or period of time for which it will accumulate billings with respect to a particular liable third party in making the decision whether to seek recovery of reimbursement.
(a) FFP is not available in Medicaid payments if—
(1) The agency failed to fulfill the requirements of §§ 433.138 and 433.139 with regard to establishing liability and seeking reimbursement from a third party;
(2) The agency received reimbursement from a liable third party; or
(3) A private insurer would have been obligated to pay for the service except that its insurance contract limits or excludes payments if the individual is eligible for Medicaid.
(b) FFP is available at the 50 percent rate for the agency's expenditures in carrying out the requirements of this subpart.
(c) If the State receives FFP in Medicaid payments for which it receives third party reimbursement, the State must pay the Federal government a portion of the reimbursement determined in accordance with the FMAP for the State. This payment may be reduced by the total amount needed to meet the incentive payment in § 433.153.
(a) A State plan must provide that, as a condition of eligibility, each legally able applicant or recipient is required to:
(1) Assign to the Medicaid agency his or her rights, or the rights of any other individual eligible under the plan for whom he or she can legally make an assignment, to medical support and to payment for medical care from any third party;
(2) Cooperate with the agency in establishing paternity and in obtaining medical support and payments, unless the individual establishes good cause for not cooperating, and except for individuals described in section 1902(l)(1)(A) of the Act (poverty level pregnant women), who are exempt from cooperating in establishing paternity and obtaining medical support and payments from, or derived from, the father of the child born out of wedlock; and
(3) Cooperate in identifying and providing information to assist the Medicaid agency in pursuing third parties who may be liable to pay for care and services under the plan, unless the individual establishes good cause for not cooperating.
(b) A State plan must provide that the requirements for assignments, cooperation in establishing paternity and obtaining support, and cooperation in identifying and providing information to assist the State in pursuing any liable third party under §§ 433.146 through 433.148 are met.
(c) A State plan must provide that the assignment of rights to benefits obtained from an applicant or recipient is effective only for services that are reimbursed by Medicaid.
(a) Except as specified in paragraph (b) of this section, the agency must require the individual to assign to the State—
(1) His own rights to any medical care support available under an order of a court or an administrative agency,
(2) The rights of any other individual eligible under the plan, for whom he can legally make an assignment.
(b) Assignment of rights to benefits may not include assignment of rights to Medicare benefits.
(c) If assignment of rights to benefits is automatic because of State law, the agency may substitute such an assignment for an individual executed assignment, as long as the agency informs the individual of the terms and consequences of the State law.
(a)
(1) Establishing paternity of a child born out of wedlock and obtaining medical support and payments for himself or herself and any other person for whom the individual can legally assign rights, except that individuals described in section 1902(l)(1)(A) of the Act (poverty level pregnant women) are exempt from these requirements involving paternity and obtaining medical support and payments from, or derived from, the father of the child born out of wedlock; and
(2) Identifying and providing information to assist the Medicaid agency in pursuing third parties who may be liable to pay for care and services under the plan.
(b)
(1) Appear at a State or local office designated by the agency to provide information or evidence relevant to the case;
(2) Appear as a witness at a court or other proceeding;
(3) Provide information, or attest to lack of information, under penalty of perjury;
(4) Pay to the agency any support or medical care funds received that are covered by the assignment of rights; and
(5) Take any other reasonable steps to assist in establishing paternity and securing medical support and payments, and in identifying and providing information to assist the State in pursuing any liable third party.
(c)
(1) With respect to establishing paternity of a child born out of wedlock or obtaining medical care support and payments, or identifying or providing information to assist the State in pursuing any liable third party for a child for whom the individual can legally assign rights, the agency must find the cooperation is against the best interests of the child, in accordance with factors specified for the Child Support Enforcement Program at 45 CFR part 232. If the State title IV-A agency has made a finding that good cause for refusal to cooperate does or does not exist, the Medicaid agency must adopt that finding as its own for this purpose.
(2) With respect to obtaining medical care support and payments for an individual and identifying and providing information to assist in pursuing liable third parties in any case not covered by paragraph (c)(1) of this section, the agency must find that cooperation is against the best interests of the individual or the person to whom Medicaid is being furnished because it is anticipated that cooperation will result in reprisal against, and cause physical or emotional harm to, the individual or other person.
(d)
In administering the assignment of rights provision, the agency must:
(a) Deny or terminate eligibility for any applicant or recipient who—
(1) Refuses to assign his own rights or those of any other individual for whom he can legally make an assignment; or
(2) Refuses to cooperate as required under § 433.147(a) unless cooperation has been waived;
(b) Provide Medicaid to any individual who—
(1) Cannot legally assign his own rights; and
(2) Would otherwise be eligible for Medicaid but for the refusal, by a person legally able to assign his rights, to assign his rights or to cooperate as required by this subpart; and
(c) In denying or terminating eligibility, comply with the notice and hearing requirements of part 431, subpart E of this subchapter.
For medical assistance furnished on or after October 1, 1984—
(a) A State plan must provide for entering into written cooperative agreements for enforcement of rights to and collection of third party benefits with at least one of the following entities: The State title IV-D agency, any appropriate agency of any State, and appropriate courts and law enforcement officials. The agreements must be in accordance with the provisions of § 433.152.
(b) A State plan must provide that the requirements for making incentive payments and for distributing third party collections specified in §§ 433.153 and 433.154 are met.
(a) Except as specified in paragraph (b) of this section, the State agency may develop the specific terms of cooperative agreements with other agencies as it determines appropriate for individual circumstances.
(b) Agreements with title IV-D agencies must specify that the Medicaid agency will—
(1) Meet the requirements of the Office of Child Support Enforcement for cooperative agreements under 45 CFR Part 306; and
(2) Provide reimbursement to the IV-D agency only for those child support services performed that are not reimbursable by the Office of Child Support Enforcement under title IV-D of the Act and that are necessary for the collection of amounts for the Medicaid program.
(a)
(b)
(c)
(1) The agency must pay all of the incentive payment to the political subdivision, legal entity of the subdivision, or another State that collected medical support and payments at the request of the agency.
(2) The political subdivision, legal entity or other State that receives the incentive payment must then divide the incentive payment equally with any other political subdivisions, legal entities, or other States that assisted in
The agency must distribute collections as follows—
(a) To itself, an amount equal to State Medicaid expenditures for the individual on whose right the collection was based.
(b) To the Federal Government, the Federal share of the State Medicaid expenditures, minus any incentive payment made in accordance with § 433.153.
(c) To the recipient, any remaining amount. This amount must be treated as income or resources under part 435 or part 436 of this subchapter, as appropriate.
This subpart implements—
(a) Section 1903(d)(2)(A) of the Act, which directs that quarterly Federal payments to the States under title XIX (Medicaid) of the Act are to be reduced or increased to make adjustment for prior overpayments or underpayments that the Secretary determines have been made.
(b) Section 1903(d)(2) (C) and (D) of the Act, which provides that a State has 60 days from discovery of an overpayment for Medicaid services to recover or attempt to recover the overpayment from the provider before adjustment in the Federal Medicaid payment to the State is made; and that adjustment will be made at the end of the 60 days, whether or not recovery is made, unless the State is unable to recover from a provider because the overpayment is a debt that has been discharged in bankruptcy or is otherwise uncollectable.
(c) Section 1903(d)(3) of the Act, which provides that the Secretary will consider the pro rata Federal share of the net amount recovered by a State during any quarter to be an overpayment.
This subpart sets forth the requirements and procedures under which States have 60 days following discovery of overpayments made to providers for Medicaid services to recover or attempt to recover that amount before the States must refund the Federal share of these overpayments to CMS, with certain exceptions.
As used in this subpart—
(a)
(1) Overpayments made to providers that are discovered by the State;
(2) Overpayments made to providers that are initially discovered by the provider and made known to the State agency; and
(3) Overpayments that are discovered through Federal reviews.
(b)
(1) Cases involving third party liability because, in these situations, recovery is sought for a Medicaid payment that would have been made had another party not been legally responsible for payment; and
(2) Probate collections from the estates of deceased Medicaid recipients, as they represent the recovery of payments properly made from resources later determined to be available to the State.
(c)
In such cases, the State is not required to refund the Federal share explicitly related to the original overpayment in accordance with the regulations in this subpart. Refund of the Federal share occurs when the State claims future expenditures made to the provider at a reduced rate.
(2) Unallowable costs for a prior year paid to an institutional provider under a rate-setting system that a State seeks to recover in a lump sum, by an installment repayment plan, or through reduction of future payments to which the provider would otherwise be entitled constitute overpayments that are subject to the requirements of this subpart.
(d)
(a)
(2) The agency must refund the Federal share of overpayments at the end of the 60-day period following discovery in accordance with the requirements of this subpart, whether or not the State has recovered the overpayment from the provider.
(b)
(c)
(2) The date upon which an overpayment occurs is the date upon which a State, using its normal method of reimbursement for a particular class of provider (e.g., check, interfund transfer), makes the payment involving unallowable costs to a provider.
(a)
(b)
(c)
(1) The date on which any Medicaid agency official or other State official first notifies a provider in writing of an overpayment and specifies a dollar amount that is subject to recovery;
(2) The date on which a provider initially acknowledges a specific overpaid amount in writing to the medicaid agency; or
(3) The date on which any State official or fiscal agent of the State initiates a formal action to recoup a specific overpaid amount from a provider without having first notified the provider in writing.
(d)
(e)
(f)
(1) A downward adjustment in the amount of an overpayment subject to recovery that occurs after discovery does not change the original 60-day recovery period for the outstanding balance.
(2) An upward adjustment in the amount of an overpayment subject to recovery that occurs during the 60-day period following discovery does not change the 60-day recovery period for the original overpayment amount. A new 60-day period begins for the incremental amount only, beginning with the date of the State's written notification to the provider regarding the upward adjustment.
(g)
(h)
(a)
(2) The agency must notify the provider that an overpayment exists in
(b)
(1) The provider has filed for bankruptcy, as specified in paragraph (c) of this section; or
(2) The provider has gone out of business and the State is unable to locate the provider and its assets, as specified in paragraph (d) of this section.
(c)
(1) The provider has filed for bankruptcy in Federal court at the time of discovery of the overpayment or the provider files a bankruptcy petition in Federal court before the end of the 60-day period following discovery; and
(2) The State is on record with the court as a creditor of the petitioner in the amount of the Medicaid overpayment.
(d)
(2) A provider is considered to be out of business on the effective date of a determination to that effect under State law. The agency must—
(i) Document its efforts to locate the party and its assets. These efforts must be consistent with applicable State policies and procedures; and
(ii) Make available an affidavit or certification from the appropriate State legal authority establishing that the provider is out of business and that the overpayment cannot be collected under State law and procedures and citing the effective date of that determination under State law.
(3) A provider is not out of business when ownershp is transferred within the State unless State law and procedures deem a provider that has transferred ownership to be out of business and preclude collection of the overpayment from the provider.
(e)
(a)
(2) The Federal share of overpayments subject to recovery must be credited on the Form CMS-64 report submitted for the quarter in which the 60-day period following discovery, established in accordance with § 433.316, ends.
(3) A credit on the Form CMS-64 must be made whether or not the overpayment has been recovered by the State from the provider.
(b)
(2) The State is not required to report on the Form CMS-64 any collections made on overpayment amounts for which the Federal share has been refunded previously.
(3) If a State has refunded the Federal share of an overpayment as required under this subpart and the State
(c)
(1) Downward adjustment to an overpayment amount previously credited to CMS is allowed only if it is properly based on the approved State plan, Federal law and regulations governing Medicaid, and the appeals resolution processes specified in State administrative policies and procedures.
(2) The 2-year filing limit for retroactive claims for Medicaid expenditures does not apply. A downward adjustment is not considered a retroactive claim but rather a reclaiming of costs previously claimed.
(d)
(e)
(f)
(1) The Form CMS-64 submission due to CMS immediately following the date of the decision of the court; or
(2) The Form CMS-64 submission for the quarter in which the 60-day period following discovery of the overpayment ends.
(g)
(2) If the agency reclaims a refund of the Federal share of an overpayment—
(i) In bankruptcy cases, the agency must submit to CMS a statement of its efforts to recover the overpayment during the period before the petition for bankruptcy was filed; and
(ii) In out-of-business cases, the agency must submit to CMS a statement of its efforts to locate the provider and its assets and to recover the overpayment during any period before the provider is found to be out of business in accordance with § 433.318.
(h)
(1) Amounts of overpayments not collected during the quarter but refunded because of the expiration of the 60-day period following discovery;
(2) Upward and downward adjustments to amounts credited in previous quarters;
(3) Amounts of overpayments collected under court-approved discharges of bankruptcy;
(4) Amounts of previously reported overpayments to providers certified as bankrupt or out of business during the quarter; and
(5) Amounts of overpayments previously credited and reclaimed by the State.
The Medicaid agency must maintain a separate record of all overpayment activities for each provider in a manner that satisfies the retention and access requirements of 45 CFR part 74, subpart D.
Sec. 1102 of the Social Security Act (42 U.S.C. 1302).
(a)
(b)
As used in this part, unless the context indicates otherwise—
(a) Is supported in whole or in part by Federal project grant financial assistance; and
(b) Provides or arranges for medical services to recipients.
(a) Is not, as a matter of regular business, a health insuring organization or a community health care center;
(b) Provides medical care to its residents through contracts or other arrangements with medical providers; and
(c) Receives capitation payments from the Medicaid agency, under a nonrisk contract, for its residents who are eligible for Medicaid.
If the State plan provides for contracts of the types covered by this part, the plan must also provide for meeting the applicable requirements of this part.
(a)
(1) Include provisions that define a sound and complete procurement contract, as required by 45 CFR part 74;
(2) Identify the population covered by the contract;
(3) Specify any procedures for enrollment or reenrollment of the covered population;
(4) Specify the amount, duration, and scope of medical services to be provided or paid for;
(5) Provide that the agency and HHS may evaluate through inspection or other means, the quality, appropriateness and timeliness of services performed under the contract;
(6) Specify procedures and criteria for terminating the contract, including a requirement that the contractor promptly supply all information necessary for the reimbursement of any outstanding Medicaid claims;
(7) Provide that the contractor maintains an appropriate record system for services to enrolled recipients;
(8) Provide that the contractor safeguards information about recipients as required by part 431, subpart F of this chapter;
(9) Specify any activities to be performed by the contractor that are related to third party liability requirements in part 433, subpart D of this chapter;
(10) Specify which functions may be subcontracted; and
(11) Provide that any subcontracts meet the requirements of paragraph (b) of this section.
(b)
(c)
Contracts with fiscal agents must—
(a) Meet the requirements of § 434.6;
(b) Include termination procedures that require the contractors to supply promptly all material necessary for continued operation of payment and related systems. This material includes—
(1) Computer programs;
(2) Data files;
(3) User and operation manuals, and other documentation;
(4) System and program documentation; and
(5) Training programs for Medicaid agency staff, their agents or designated representatives in the operation and maintenance of the system;
(c) Offer to the State one or both of the following options, if the fiscal agent or the fiscal agent's subcontractor has a proprietary right to material specified in paragraph (b) of this section:
(1) Purchasing the material; or
(2) Purchasing the use of the material through leasing or other means; and
(d) State that payment to providers will be made in accordance with part 447 of this chapter.
Contracts with private nonmedical institutions must—
(a) Meet the requirements of § 434.6;
(b) Specify a capitation fee based on the cost of the services provided, in accordance with the reimbursement requirements prescribed in part 447 of this chapter; and
(c) Specify when the capitation fee must be paid.
(a) Contracts with health insuring organizations that are not subject to the requirements in section 1903(m)(2)(A) must:
(1) Meet the general requirements for all contracts and subcontracts specified in § 434.6;
(2) Specify that the contractor assumes at least part of the underwriting risk and;
(i) If the contractor assumes the full underwriting risk, specify that payment of the capitation fees to the contractor during the contract period constitutes full payment by the agency for
(ii) If the contractor assumes less than the full underwriting risk, specify how the risk is apportioned between the agency and the contractor;
(3) Specify whether the contractor returns to the agency part of any savings remaining after the allowable costs are deducted from the capitations fees, and if savings are returned, the apportionment between agency and the contractor; and
(4) Specify the extent, if any, to which the contractor may obtain reinsurance of a portion of the underwriting risk.
(b) The contract must—
(1) Specify that the capitation fee will not exceed the limits set forth under part 447 of this chapter.
(2) Specify that, except as permitted under paragraph (b) of this section, the capitation fee paid on behalf of each recipient may not be renegotiated—
(i) During the contract period if the contract period is 1 year or less; or
(ii) More often than annually if the contract period is for more than 1 year.
(3) Specify that the capitation fee will not include any amount for recoupment of any specific losses suffered by the contractor for risks assumed under the same contract or a prior contract with the agency; and
(4) Specify the actuarial basis for computation of the capitation fee.
(c) The capitation fee may be renegotiated more frequently than annually for recipients who are not enrolled at the time of renegotiation or if the renegotiation is required by changes in Federal or State law.
(a)
(1) Meets the requirements of this part;
(2) Meets the applicable requirements of 45 CFR part 74; and
(3) Is in effect.
(b)
Under each contract with a fiscal agent—
(a) The amount paid to the provider of medical services is a medical assistance cost; and
(b) The amount paid to the contractor for performing the agreed-upon functions is an administrative cost.
A Medicaid agency dissatisfied with a disallowance of FFP under this subpart may request and will be granted reconsideration in accordance with 45 CFR part 16.
Sec. 1102 of the Social Security Act (42 U.S.C. 1302).
This part sets forth, for the 50 States, the District of Columbia, the Northern Mariana Islands, and American Samoa—
(a) The eligibility provisions that a State plan must contain;
(b) The mandatory and optional groups of individuals to whom Medicaid is provided under a State plan;
(c) The eligibility requirements and procedures that the Medicaid agency must use in determining and redetermining eligibility, and requirements it may not use;
(d) The availability of FFP for providing Medicaid and for administering the eligibility provisions of the plan; and
(e) Other requirements concerning eligibility determinations, such as use of an institutionalized individual's income for the cost of care.
(a) This part implements the following sections of the Act and public laws that mandate eligibility requirements and standards:
State residence requirements excluding individuals who reside in the state; and
Citizenship requirement excluding United States citizens.
(b) This part implements the following other provisions of the Act or public laws that establish additional State plan requirements:
As used in this part—
(1)
(i) Has a family income at or below 200 percent of the Federal poverty line for a family of the size involved; and
(ii) Resides in a State with no Medicaid applicable income level (as defined at § 457.10 of this chapter); or
(iii) Resides in a State that has a Medicaid applicable income level (as defined at § 457.10 of this chapter) and has family income that either:
(A) Exceeds the Medicaid applicable income level for the age of such child, but not by more than 50 percentage points; or
(B) Does not exceed the income level specified for such child to be eligible for medical assistance under the policies of the State plan under title XIX on June 1, 1997.
(2)
(i) A child shall not be considered to be covered by health insurance coverage based on coverage offered by the State under a program in operation prior to July 1, 1997 if that program received no Federal financial participation;
(ii) A child shall not be considered to be covered under a group health plan or health insurance coverage if the child did not have reasonable geographic access to care under that coverage.
(3) For purposes of this section, policies of the State plan a under title XIX plan include policies under a Statewide demonstration project under section 1115(a) of the Act other than a demonstration project that covered an expanded group of eligible children but that either—
(i) Did not provide inpatient hospital coverage; or
(ii) Limited eligibility to children previously enrolled in Medicaid, imposed premiums as a condition of initial or continued enrollment, and did not impose a general time limit on eligibility.
A State plan must—
(a) Provide that the requirements of this part are met; and
(b) Specify the groups to whom Medicaid is provided, as specified in subparts B, C, and D of this part, and the conditions of eligibility for individuals in those groups.
This subpart prescribes requirements for coverage of categorically needy individuals.
(a) A Medicaid agency must provide Medicaid to individuals receiving AFDC.
(b) For purposes of this section, an individual is receiving AFDC if his needs are included in determining the amount of the AFDC payment. This includes an individual whose presence in the home is considered essential to the well-being of a recipient (see 45 CFR 233.20(a)(2)(vi)) and who could be a recipient under the State's AFDC plan if that plan were as broad as allowed under the Act for FFP.
(a) If a family loses AFDC solely because of increased income from employment or increased hours of employment, the agency must continue to provide Medicaid for 4 months to all members of the family if—
(1) The family received AFDC in any 3 or more months during the 6-month period immediately before the month in which it became ineligible for AFDC; and
(2) At least one member of the family is employed throughout the 4-month period, although this need not be the same member for the whole period.
(b) The 4 calendar month period begins on the date AFDC is terminated. If AFDC benefits are terminated retroactively, the 4 calendar month period also begins retroactively with the first month in which AFDC was erroneously paid.
The agency must provide Medicaid to:
(a) Individuals denied AFDC solely because of policies requiring the deeming of income and resources of the following individuals who are not included as financially responsible relatives under section 1902(a)(17)(D) of the Act;
(1) Stepparents who are not legally liable for support of stepchildren under a State law of general applicability;
(2) Grandparents;
(3) Legal guardians;
(4) Alien sponsors who are not organizations; and
(5) Siblings.
(b) [Reserved]
The agency must provide Medicaid to individuals who meet the following conditions:
(a) In August 1972, the individual was entitled to OASDI and—
(1) He was receiving AFDC; or
(2) He would have been eligible for AFDC if he had applied, and the Medicaid plan covered this optional group; or
(3) He would have been eligible for AFDC if he were not in a medical institution or intermediate care facility, and the Medicaid plan covered this optional group.
(b) The individual would currently be eligible for AFDC except that the increase in OASDI under Pub. L. 92-336 raised his income over the limit allowed under AFDC. This includes an individual who—
(1) Meets all current AFDC requirements except for the requirement to file an application; or
(2) Would meet all current AFDC requirements if he were not in a medical institution or intermediate care facility, and the current Medicaid plan covers this optional group.
(a) The Medicaid agency must provide Medicaid to individuals deemed to be receiving AFDC, as specified in this section.
(b) The State must deem individuals to be receiving AFDC who are denied a cash payment from the title IV-A State agency solely because the amount of
(c) The State may deem participants in a work supplementation program to be receiving AFDC under section 414(g) of the Act. This section permits States, for purposes of title XIX, to deem an individual and any child or relative of the individual (or other individual living in the same household) to be receiving AFDC, if the individual—
(1) Participates in a State-operated work supplementation program under section 414 of the Act; and
(2) Would be eligible for an AFDC cash payment if the individual were not participating in the work supplementation program.
(d) The State must deem to be receiving AFDC those individuals who are denied AFDC payments from the title IV-A State agency solely because that agency is recovering an overpayment.
(e) The State must deem to be receiving AFDC individuals described in section 473(a)(1) of the Act—
(1) For whom an adoption assistance agreement is in effect under title IV-E of the Act, whether or not adoption assistance is being provided or an interlocutory or other judicial decree of adoption has been issued; or
(2) For whom foster care maintenance payments are made under title IV-E of the Act.
(f) The State must deem an individual to be receiving AFDC if a new collection or increased collection of child or spousal support under title IV-D of the Social Security Act results in the termination of AFDC eligibility in accordance with section 406(h) of the Social Security Act. States must continue to provide Medicaid for four consecutive calendar months, beginning with the first month of AFDC ineligibility, to each dependent child and each relative with whom such a child is living (including the eligible spouse of such relative as described in section 406(b) of the Social Security Act) who:
(1) Becomes ineligible for AFDC on or after August 16, 1984; and
(2) Has received AFDC for at least three of the six months immediately preceding the month in which the individual becomes ineligible for AFDC; and
(3) Becomes ineligible for AFDC wholly or partly as a result of the initiation of or an increase in the amount of the child or spousal support collection under title IV-D.
(g)(1) Except as provided in paragraph (g)(2) of this section, individuals who are eligible for extended Medicaid lose this coverage if they move to another State during the 4-month period. However, if they move back to and reestablish residence in the State in which they have extended coverage, they are eligible for any of the months remaining in the 4-month period in which they are residents of the State.
(2) If a State has chosen in its State plan to provide Medicaid to non-residents, the State may continue to provide the 4-month extended benefits to individuals who have moved to another State.
(h) For purposes of paragraph (f) of this section:
(1) The new collection or increased collection of child or spousal support results in the termination of AFDC eligibility when it actively causes or contributes to the termination. This occurs when:
(i) The change in support collection in and of itself is sufficient to cause ineligibility. This rule applies even if the support collection must be added to other, stable income. It also applies even if other independent factors, alone or in combination with each other, might simultaneously cause ineligibility; or
(ii) The change in support contributes to ineligibility but does not by itself cause ineligibility. Ineligibility must result when the change in support is combined with other changes in income or changes in other circumstances and the other changes in income or circumstances cannot alone or in combination result in termination without the change in support.
(2) In cases of increases in the amounts of both support collections and earned income, eligibility under this section does not preclude eligibility under 45 CFR 233.20(a)(14) or section 1925 of the Social Security Act (which was added by section 303(a) of the Family Support Act of 1988 (42 U.S.C. 1396r-6)). Extended periods resulting from both an increase in the
(a) The agency must provide Medicaid to a pregnant woman whose pregnancy has been medically verified and who—
(1) Would be eligible for an AFDC cash payment (or would be eligible for an AFDC cash payment if coverage under the State's AFDC plan included an AFDC-unemployed parents program) if her child had been born and was living with her in the month of payment;
(2) Is a member of a family that would be eligible for an AFDC cash payment if the State's AFDC plan included an AFDC-unemployed parents program; or
(3) Meets the income and resource requirements of the State's approved AFDC plan. In determining whether the woman meets the AFDC income and resource requirements, the unborn child or children are considered members of the household, and the woman's family is treated as though deprivation exists.
(b) The provisions of paragraphs (a) (1) and (2) of this section are effective October 1, 1984. The provisions of paragraph (a)(3) of this section are effective July 1, 1986.
(c) The agency must provide Medicaid to children who meet all of the following criteria:
(1) They are born after September 30, 1983;
(2) Effective October 1, 1988, they are under age 6 (or if designated by the State, any age that exceeds age 6 but does not exceed age 8), and effective October 1, 1989, they are under age 7 (or if designated by the State, any age that exceeds age 7 but does not exceed age 8); and
(3) They meet the income and resource requirements of the State's approved AFDC plan.
(a) The agency must provide Medicaid eligibility to a child born to a woman who has applied for, has been determined eligible and is receiving Medicaid on the date of the child's birth. The child is deemed to have applied and been found eligible for Medicaid on the date of birth and remains eligible for one year so long as the woman remains (or would remain if pregnant) eligible and the child is a member of the woman's household. This provision applies in instances where the labor and delivery services were furnished prior to the date of application and covered by Medicaid based on retroactive eligibility.
(b) The agency must provide Medicaid eligibility in the same manner described in paragraph (a) of this section to a child born to an otherwise-eligible qualified alien woman subject to the 5-year bar so long as the woman has filed a complete Medicaid application, including but not limited to meeting residency, income and resource requirements, has been determined eligible, is receiving Medicaid on the date of the child's birth, and remains (or would remain if pregnant) Medicaid eligible. All standard Medicaid application procedures apply, including timely determination of eligibility and adequate notice of the agency's decision concerning eligibility. A 5-year bar qualified alien receiving emergency medical services only under § 435.139 is considered to be Medicaid-eligible and receiving Medicaid for purposes of this provision. With respect to whether the mother remains (or would remain if pregnant) eligible for Medicaid after the birth of the child, the State must determine whether a 5-year bar qualified alien would remain eligible for emergency services under § 435.139. In determining whether the woman would remain eligible for these services, the State must consider whether the
(c) The agency must provide Medicaid eligibility in the same manner described in paragraph (a) of this section to a child born to an otherwise-eligible non-qualified alien woman so long as the woman has filed a complete Medicaid application (other than providing a social security number or demonstrating immigration status), including but not limited to meeting residency, income and resource requirements, has been determined eligible, is receiving Medicaid on the date of the child's birth, and remains (or would remain if pregnant) Medicaid eligible. All standard Medicaid application procedures apply, including timely determination of eligibility and adequate notice of the agency's decision concerning eligibility. A non-qualified alien receiving emergency medical services only under § 435.139 is considered to be Medicaid-eligible and receiving Medicaid for purposes of this provision. With respect to whether the mother remains (or would remain if pregnant) eligible for Medicaid after the birth of the child, the State must determine whether a non-qualified alien would remain eligible for emergency services under § 435.139. In determining whether the woman would remain eligible for these services, the State must consider whether the woman would remain eligible if pregnant. This provision applies in instances where the labor and delivery services were furnished prior to the date of application and covered by Medicaid based on retroactive eligibility.
(d) A redetermination of eligibility must be completed on behalf of the children described in this provision in accordance with the procedures at § 435.916. At that time, the State must collect documentary evidence of citizenship and identity as required under § 435.406.
(a)
(b)
(c)
Except as allowed under § 435.121, the agency must provide Medicaid to aged, blind, and disabled individuals or couples who are receiving or are deemed to be receiving SSI. This includes individuals who are—
(a) Receiving SSI pending a final determination of blindness or disability;
(b) Receiving SSI under an agreement with the Social Security Administration to dispose of resources that exceed the SSI dollar limits on resources; or
(c) Receiving benefits under section 1619(a) of the Act or in section 1619(b) status (blind individuals or those with disabling impairments whose income equals or exceeds a specific Supplemental Security Income limit). (Regulations at 20 CFR 416.260 through 416.269 contain requirements governing determinations of eligibility under this provision.) For purposes of this paragraph (c), this mandatory categorically needy group of individuals includes
(a)
(2) Except to the extent provided in paragraph (a)(3) of this section, the agency may elect to apply more restrictive eligibility requirements to the aged, blind, and disabled that are more restrictive than those of the SSI program. The more restrictive requirements may be no more restrictive than those requirements contained in the State's Medicaid plan in effect on January 1, 1972. If any of the State's 1972 Medicaid plan requirements were more liberal than of the SSI program, the State must use the SSI requirement instead of the more liberal requirements, except to the extent the State elects to use more liberal criteria under § 435.601.
(3) The agency must not apply a more restrictive requirement under the provisions of paragraph (a)(2) of this section if:
(i) The requirement conflicts with the requirements of section 1924 of the Act, which governs the eligibility and post-eligibility treatment of income and resources of institutionalized individuals with community spouses;
(ii) The requirement conflicts with a more liberal requirement which the agency has elected to use under § 435.601; or
(iii) The more restrictive requirement conflicts with a more liberal requirement the State has elected to use under § 435.234(c) in determining eligibility for State supplementary payments.
(b)
(1) Individuals who meet the requirements of section 1619(b)(3) of the Act even though they may not continue to meet the requirements of this section; and
(2) Qualified Medicare beneficiaries described in section 1905(p) of the Act and qualified working disabled individuals described in section 1905(s) of the Act without consideration of the more restrictive eligibility requirements specified in this section.
(3) Individuals who:
(i) Qualify for benefits under section 1619(a) or are in eligibility status under section 1619(b)(1) of the Act as determined by SSA; and
(ii) Were eligible for Medicaid under the more restrictive criteria in the State's approved Medicaid plan in the reference month—the month immediately preceding the first month in which they became eligible under section 1619(a) or (b)(1) of the Act. “Were eligible for Medicaid” means that individuals were issued Medicaid cards by the State for the reference month. Under this provision, the reference month for determining Medicaid eligibility for all individuals under section 1619 of the Act is the month immediately preceding the first month of the most recent period of eligibility under section 1619 of the Act.
(c)
(d)
(e)
(2) Any income eligibility standards that the agency applies must:
(i) Equal the income standard (or Federal Benefit Rate (FBR)) that would be used under SSI based on an individual's living arrangement; or
(ii) Be a more restrictive standard which is no more restrictive than that under the approved State's January 1, 1972 Medicaid plan.
(3) If the categorically needy income standard established under paragraph (e)(2) of this section is less than the optional categorically needy standard established under § 435.230, the agency must provide Medicaid to all aged, blind, and disabled individuals who have income equal to or below the higher standard.
(4) In a State that does not have a medically needy program that covers aged, blind, and disabled individuals, the agency must allow individuals to deduct from income incurred medical and remedial expenses (that is, spend down) to become eligible under this section. However, individuals with income above the categorically needy standards may only spend down to the standard selected by the State under paragraph (e)(2) of this section which applies to the individual's living arrangement.
(5) In a State that elects to provide medically needy coverage to aged, blind, and disabled individuals, the agency must allow individuals to deduct from income incurred medical and remedial care expenses (spend down) to become categorically needy when they are SSI recipients (including individuals deemed to be SSI recipients under §§ 435.135, 435.137, and 435.138), eligible spouses of SSI recipients, State supplement recipients, and individuals who are eligible for a supplement but who do not receive supplementary payments. Such persons may only spend down to the standard selected by the State under paragraph (e)(2) of this section. Individuals who are not SSI recipients, eligible spouses of SSI recipients, State supplement recipients, or individuals who are eligible for a supplement must spend down to the State's medically needy income standards for aged, blind, and disabled individuals in order to become Medicaid eligible.
(f)
(i) SSI payments;
(ii) State supplementary payments that meet the conditions specified in §§ 435.232 and 435.234; and
(iii) Expenses incurred by the individual or financially responsible relatives for necessary medical and remedial services that are recognized under State law and are not subject to payment by a third party, unless the third party is a public program of a State or political subdivision of a State. These expenses include Medicare and other health insurance premiums, deductions and coinsurance charges, and copayments or deductibles imposed under § 447.51 or § 447.53 of this chapter. The agency may set reasonable limits on the amounts of incurred medical expenses that are deducted.
(2) For purposes of counting income with respect to individuals who are receiving benefits under section 1619(a) f the Act or are in section 1619(b)(1) of the Act status but who do not meet the requirements of paragraph (b)(3)(ii) of this section, the agency may disregard some or all of the amount of the individual's income that is in excess of the SSI Federal benefit rate under section 1611(b) of the Act.
If an agency provides Medicaid to aged, blind, or disabled individuals receiving SSI or optional State supplements, it must provide Medicaid to individuals who would be eligible for SSI or optional State supplements except for an eligibility requirement used in those programs that is specifically prohibited under title XIX.
The agency must provide Medicaid to individuals receiving mandatory State supplements.
(a) The agency must provide Medicaid to any person who was eligible for Medicaid in December 1973 as an essential spouse of an aged, blind, or disabled individual who was receiving cash assistance, if the conditions in paragraph (b) of this section are met. An “essential spouse” is defined in section 1905(a) of the Act as one who is living with the individual; whose needs were included in determining the amount of cash payment to the individual under OAA, AB, APTD, or AABD; and who is determined essential to the individual's well-being.
(b) The agency must continue Medicaid if—
(1) The aged, blind, or disabled individual continues to meet the December 1973 eligibility requirements of the applicable State cash assistance plan; and
(2) The essential spouse continues to meet the conditions that were in effect in December 1973 under the applicable cash assistance plan for having his needs included in computing the payment to the aged, blind, or disabled individual.
The agency must provide Medicaid to individuals who were eligible for Medicaid in December 1973, or any part of that month, as inpatients of medical institutions or residents of intermediate care facilities that were participating in the Medicaid program and who—
(a) For each consecutive month after December 1973—
(1) Continue to meet the requirements for Medicaid eligibility that were in effect under the State's plan in December 1973 for institutionalized individuals; and
(2) Remain institutionalized; and
(b) Are determined by the State or a professional standards review organization to continue to need institutional care.
The agency must provide Medicaid to individuals who—
(a) Meet all current requirements for Medicaid eligibility except the criteria for blindness or disability;
(b) Were eligible for Medicaid in December 1973 as blind or disabled individuals, whether or not they were receiving cash assistance in December 1973; and
(c) For each consecutive month after December 1973, continue to meet the criteria for blindness or disability and the other conditions of eligibility used under the Medicaid plan in December 1973.
The agency must provide Medicaid to individuals who meet the following conditions:
(a) In August 1972, the individual was entitled to OASDI and—
(1) He was receiving OAA, AB, APTD, or AABD; or
(2) He would have been eligible for one of those programs except that he had not applied, and the Medicaid plan covered this optional group; or
(3) He would have been eligible for one of those programs if he were not in a medical institution or intermediate care facility, and the Medicaid plan covered this optional group.
(b) The individual would currently be eligible for SSI or a State supplement
(1) Meets all current SSI requirements except for the requirement to file an application; or
(2) Would meet all current SSI requirements if he were not in a medical institution or intermediate care facility, and the State's Medicaid plan covers this optional group.
(a) If an agency provides Medicaid to aged, blind, or disabled individuals receiving SSI or State supplements, it must provide Medicaid to individuals who—
(1) Are receiving OASDI;
(2) Were eligible for and receiving SSI or State supplements but became ineligible for those payments after April 1977; and
(3) Would still be eligible for SSI or State supplements if the amount of OASDI cost-of-living increases paid under section 215(i) of the Act, after the last month after April 1977 for which those individuals were both eligible for and received SSI or a State supplement and were entitled to OASDI, were deducted from current OASDI benefits.
(b) Cost-of-living increases include the increases received by the individual or his or her financially responsible spouse or other family member (e.g., a parent).
(c) If the agency adopts more restrictive eligibility requirements than those under SSI, it must provide Medicaid to individuals specified in paragraph (a) of this section on the same basis as Medicaid is provided to individuals continuing to receive SSI or State supplements. If the individual incurs enough medical expenses to reduce his or her income to the financial eligibility standard for the categorically needy, the agency must cover that individual as categorically needy. In determining the amount of his or her income, the agency may deduct the cost-of-living increases paid under section 215(i) after the last month after April 1977 for which that individual was both eligible for and received SSI or a State supplement and was entitled to OASDI, up to the amount that made him or her ineligible for SSI.
An agency must—
(a) Provide a one-time notice of potential Medicaid eligibility under § 435.135 to all individuals who meet the requirements of § 435.135 (a) or (c) who were not receiving Medicaid as of March 9, 1984; and
(b) Establish an annual review system to identify individuals who meet the requirements of § 435.135 (a) or (c) and who lose categorically needy eligibility for Medicaid because of a loss of SSI. States without medically needy programs must send notices of potential eligibility for Medicaid to these individuals for 3 consecutive years following their identification through the annual review system.
(a) If the agency provides Medicaid to aged, blind, or disabled individuals receiving SSI or State supplements, the agency much provide Medicaid to disabled widows and widowers who—
(1) Became ineligible for SSI or a mandatory or optional State supplement as a result of the elimination of the additional reduction factor for disabled widows and widowers under age 60 required by section 134 of Pub. L. 98-21, and for purposes of title XIX, are deemed to be title XVI payment recipients under section 1634(b) of the Social Security Act; and
(2) Meet the conditions of paragraphs (b) and (e) of this section.
(b) The individuals must meet the following conditions:
(1) They were entitled to monthly OASDI benefits under title II of the Act for December 1983:
(2) They were entitled to and received widow's or widower's disability benefits under section 202(e) or (f) of the Act for January 1984;
(3) They became ineligible for SSI or a mandatory or optional State supplement in the first month in which the increase under Pub. L. 98-21 was paid (and in which a retroactive payment for that increase for prior months was not made);
(4) They have been continously entitled to widow's or widower's disability benefits under section 202(e) or (f) from the first month that the increase under Pub. L. 98-21 was received; and
(5) They would be eligible for SSI benefits or a mandatory or optional State supplement if the amount of the increase under Pub. L. 98-21 and subsequent cost-of-living adjustments in widow's or widower's benefits under section 215(i) of the Act were deducted from their income.
(c) If the agency adopts more restrictive requirements than those under SSI, it must provide Medicaid to individuals specified in paragraph (a) of this section on the same basis as Medicaid is provided to individuals continuing to receive SSI or a mandatory or optional State supplement. The State must consider the individuals specified in paragraph (a) of this section to have no more income than the SSI Federal benefit rate if the individual was eligible for SSI in the month prior to the first month in which the increase under Public Law 98-21 was paid (and in which retroactive payments for that increase for prior months was not being made), and the individual would be eligible for SSI except for the amount of the increase under Public Law 98-21 and subsequent cost-of-living adjustments in his or her widow's or widower's benefits under section 215(i) of the Act. The State must consider individuals who qualify under paragraph (a) of this section on the basis of loss of a mandatory or optional State supplementary payment, rather than the loss of SSI, to have no more income than the relevant SSP rate. If the State's income eligibility level is lower than the SSP or SSI Federal benefit rates, individuals qualifying under paragraph (a) of this section who are deemed to have income at either the SSP rate or the SSI Federal benefit rate may further reduce their countable income by incurring medical expenses in the amount by which their income exceeds the State's income eligibility standard. When the individual has reduced his or her income by this amount, he or she will be eligible for Medicaid as categorically needy.
(d) The agency must notify each individual who may be eligible for Medicaid under this section of his or her potential eligibility, in accordance with instructions issued by the Secretary.
(e)(1) Except as provided in paragraph (e)(2) of this section, the provisions of this section apply only to those individuals who filed a written application for Medicaid on or before June 30, 1988, to obtain protected Medicaid coverage.
(2) Individuals who may be eligible under this section residing in States that use a more restrictive income standard than that of the SSI program, under section 1902(f) of the Act, have up to six months after the State sends notice pursuant to the District Court's order in
(a) If the agency provides Medicaid to aged, blind, or disabled individuals receiving SSI or State supplements, the agency must provide Medicaid to disabled widows and widowers who—
(1) Are at least age 60;
(2) Are not entitled to hospital insurance benefits under Medicare Part A; and
(3) Become ineligible for SSI or a State supplement because of mandatory application (under section 1611(e)(2)) for and receipt of widow's or widower's social security disability benefits under section 202(e) or (f) (or any other provision of section 202 if
For purposes of title XIX, individuals who meet these requirements are deemed to be title XVI payment recipients under section 1634(d) of the Act.
(b) If the agency adopts more restrictive eligibility requirements than those under SSI, it must provide Medicaid to individuals specified in paragraph (a) of this section on the same basis as Medicaid is provided to individuals continuing to receive SSI or a mandatory or optional State supplement. If the individual incurs enough medical expenses to reduce his or her income to the financial eligibility standard for the categorically needy under the State's more restrictive eligibility criteria, the agency must cover the individual as categorically needy. In determining the amount of his or her income, the agency may deduct all, part, or none of the amount of the social security disability benefits that made him or her ineligible for SSI or a State supplement, up to the amount that made him or her ineligible for SSI.
(c) Individuals who may be eligible under this section must file a written application for Medicaid. Medicaid coverage may begin no earlier than July 1, 1988.
(d) The agency must determine whether individuals may be eligible for Medicaid under this section.
The agency must provide services necessary for the treatment of an emergency medical condition, as defined in § 440.255(c) of this chapter, to those aliens described in § 435.406(c) of this subpart.
The agency must provide Medicaid to children for whom adoption assistance or foster care maintenance payments are made under title IV-E of the Act.
(a) The agency must provide categorically needy Medicaid eligibility for an extended period following termination of pregnancy to women who, while pregnant, applied for, were eligible for, and received Medicaid services on the day that their pregnancy ends. This period extends from the last day of pregnancy through the end of the month in which a 60-day period, beginning on the last day of the pregnancy, ends. Eligibility must be provided regardless of changes in the woman's financial circumstances that may occur within this extended period. These women are eligible for the extended period for all services under the plan that are pregnancy-related (as defined in § 440.210(c)(1) of this subchapter).
(b) The provisions of paragraph (a) of this section apply to Medicaid furnished on or after April 7, 1986.
This subpart specifies options for coverage of individuals as categorically needy.
(a) The agency may choose to cover as optional categorically needy any
(1) Aged individuals (65 years of age of older);
(2) Blind individuals (as defined in § 435.530);
(3) Disabled individuals (as defined in § 435.541);
(4) Individuals under age 21 (or, at State option, under age 20, 19, or 18) or reasonable classifications of these individuals;
(5) Specified relatives under section 406(b)(1) of the Act who have in their care an individual who is determined to be dependent (or would, if needy, be dependent) as specified in § 435.510; and
(6) Pregnant women.
(b) If the agency provides Medicaid to any individual in an optional group specified in paragraph (a) of this section, the agency must provide Medicaid to all individuals who apply and are found eligible to be members of that group.
(c) States that elect to use more restrictive eligibility requirements for Medicaid than the SSI requirements for any group or groups of aged, blind, and disabled individuals under § 435.121 must apply the specific requirements of § 435.230 in establishing eligibility of these groups of individuals as optional categorically needy.
The agency may provide Medicaid to any group or groups of individuals specified in § 435.201 (a)(1) through (a)(3) and (a)(5) and (a)(6) who are not mandatory categorically needy, who meet the income and resource requirements of the appropriate cash assistance program for their status (that is, the State's approved AFDC plan or SSI, or optional State supplements in States that provide Medicaid to optional State supplement recipients).
The agency may provide Medicaid to any group or groups of individuals specified in § 435.201(a) who are in title XIX reimbursable medical institutions and who:
(a) Are ineligible for the cash assistance program appropriate for their status (that is, AFDC or SSI, or optional State supplements in States that provide Medicaid to optional State supplement recipients) because of lower income standards used under the program to determine eligibility for institutionalized individuals; but
(b) Would be eligible for aid or assistance under the State's approved AFDC plan, SSI, or an optional State supplement as specified in §§ 435.232 and 435.234 if they were not institutionalized.
The State agency may provide that a recipient who is enrolled in an MCO or PCCM and who becomes ineligible for Medicaid is considered to continue to be eligible—
(a) For a period specified by the agency, ending no later than 6 months from the date of enrollment; and
(b) Except for family planning services (which the recipient may obtain from any qualified provider) only for services furnished to him or her as an MCO enrollee.
The agency may provide Medicaid to any group or groups of individuals in the community who meet the following requirements:
(a) The group would be eligible for Medicaid if institutionalized.
(b) In the absence of home and community-based services under a waiver granted under part 441—
(1) Subpart G of this subchapter, the group would otherwise require the level
(2) Subpart H of this subchapter, the group would otherwise require the level of care furnished in an NF and are age 65 or older.
(c) The group receives the waivered services.
(a) The agency may provide Medicaid to any group or groups of individuals specified under § 435.201 (a)(4), (a)(5), and (a)(6) who would meet the income and resource requirements under the State's approved AFDC plan if their work-related child care costs were paid from their earnings rather than by a State agency as a service expenditure.
(b) The agency may use this option only if the State's AFDC plan deducts work-related child care costs from income to determine the amount of AFDC.
(a) The agency may provide Medicaid to individuals under age 21 (or, at State option, under age 20, 19, or 18); or reasonable categories of these individuals as specified in paragraph (b) of this section, who are not receiving cash assistance under any program but who meet the income and resource requirements of the State's approved AFDC plan.
(b) The agency may cover all individuals described in paragraph (a) of this section or reasonable classifications of those individuals. Examples of reasonable classifications are as follows:
(1) Individuals in foster homes or private institutions for whom a public agency is assuming a full or partial financial responsibility. If the agency covers these individuals, it may also provide Medicaid to individuals of the same age placed in foster homes or private institutions by private nonprofit agencies.
(2) Individuals in adoptions subsidized in full or in part by a public agency.
(3) Individuals in nursing facilities when nursing facility services are provided under the plan to individuals within the age group selected under this provision. If the agency covers these individuals, it may also provide Medicaid to individuals in intermediate care facilities for the mentally retarded.
(4) Individuals under age 21 receiving active treatment as inpatients in pyschiatric facilities or programs, if inpatient psychiatric services for individuals under 21 are provided under the plan.
(a) The agency may provide Medicaid to any group or groups of individuals specified under § 435.210 (a)(4), (a)(5), and (a)(6) who:
(1) Would be eligible for AFDC if the State's AFDC plan included individuals whose coverage under title IV-A is optional (for example, Medicaid may be provided to members of families with an unemployed parent even though AFDC is not available to them under the State's AFDC plan); or
(2) Would be eligible for AFDC if the State's AFDC plan did not contain eligibility requirements more restrictive than, or in addition to, those required under title IV-A.
(b) The agency may cover any AFDC optional group without covering all such groups.
(a) The agency may provide Medicaid to children 18 years of age or younger who qualify under section 1614(a) of the Act, who would be eligible for Medicaid
(b) If the agency elects the option provided by paragraph (a) of this section, it must determine, in each case, that the following conditions are met:
(1) The child requires the level of care provided in a hospital, SNF, or ICF.
(2) It is appropriate to provide that level of care outside such an institution.
(3) The estimated Medicaid cost of care outside an institution is no higher than the estimated Medicaid cost of appropriate institutional care.
(c) The agency must specify in its State plan the method by which it determines the cost-effectiveness of caring for disabled children at home.
(a) The agency may provide Medicaid to individuals under the age of 21 (or, at State option, age 20, 19, or 18)—
(1) For whom an adoption agreement (other than an agreement under title IV-E) between the State and the adoptive parent(s) is in effect;
(2) Who, the State agency responsible for adoption assistance, has determined cannot be placed with adoptive parents without Medicaid because the child has special needs for medical or rehabilitative care; and
(3) Who meet either of the following:
(i) Were eligible for Medicaid under the State plan before the adoption agreement was entered into; or
(ii) Would have been eligible for Medicaid before the adoption agreement was entered into, if the eligibility standards and methodologies of the title IV-E foster care program were used without employing the threshold title IV-A eligibility determination.
(b) For adoption assistance agreements entered into before April 7, 1986—
(1) The agency must deem the requirements of paragraphs (a)(1) and (2) of this section to be met if the State adoption assistance agency determines that—
(i) At the time of the adoption placement, the child had special needs for medical or rehabilitative care that made the child difficult to place; and
(ii) There is in effect an adoption assistance agreement between the State and the adoptive parent(s).
(2) The agency must deem the requirements of paragraph (a)(3) of this section to be met if the child was found by the State to be eligible for Medicaid before the adoption assistance agreement was entered into.
The agency may provide Medicaid to—
(a) All individuals under age 19 who are optional targeted low-income children as defined in § 435.4; or
(b) Reasonable categories of these individuals.
(a)
(b)
(1) Meet the nonfinancial criteria that the State has elected to apply under § 435.121;
(2) Meet the resource requirements that the State has elected to apply under § 435.121; and
(3) Meet the income eligibility standards specified in paragraph (c) of this section.
(c)
(1) Individuals who are financially eligible for but not receiving SSI benefits and who, before deduction of incurred medical and remedial expenses, meet the State's more restrictive eligibility requirements described in § 435.121;
(2) Individuals who meet the income standards of the following eligibility groups:
(i) Individuals who would be eligible for cash assistance except for institutional status described in § 435.211;
(ii) Individuals who are enrolled in an HMO or other entity and who are deemed to continue to be Medicaid eligible for a period specified by the agency up to 6 months from the date of enrollment and who became ineligible during the specified enrollment period, as described in § 435.212;
(iii) Individuals receiving home and community-based waiver services described in § 435.217;
(iv) Individuals receiving only optional State supplements described in § 435.234;
(v) Institutionalized individuals with income below a special income level described in § 435.236;
(vi) Aged and disabled individuals who have income below 100 percent of the Federal poverty level described in section 1905(m) of the Act.
(3) Individuals who qualify for special status under §§ 435.135 and 435.138, and with respect to whom the State elects to disregard some or the maximum amount of title II payments permitted to be disregarded under those sections.
(d)
(a) If the agency provides Medicaid to individuals receiving SSI under § 435.120, it may provide Medicaid, in one or more of the following classifications, to individuals who receive only an optional State supplement that meets the conditions specified in paragraph (b) of this section and who would be eligible for SSI except for the level of their income.
(1) All aged individuals.
(2) All blind individuals.
(3) All disabled individuals.
(4) Only aged individuals in domiciliary facilities or other group living arrangements as defined under SSI.
(5) Only blind individuals in domiciliary facilities or other group living arrangements as defined under SSI.
(6) Only disabled individuals in domiciliary facilities or other group living arrangements as defined under SSI.
(7) Individuals receiving a federally administered optional State supplement that meets the conditions specified in this section.
(8) Individuals in additional classifications specified by the Secretary for federally administered supplementary payments under 20 CFR 416.2020(d).
(9) Reasonable groups of individuals, as specified by the State, receiving State-administered supplementary payments.
(b) Payments under the optional supplement program must be—
(1) Based on need and paid in cash on a regular basis;
(2) Equal to the difference between the individual's countable income and the income standard used to determine eligibility for supplement. Countable income is income remaining after deductions required under SSI or, at State option, more liberal deductions are made (see § 435.1006 for limitations on FFP in Medicaid expenditures for individuals receiving optional State supplements); and
(3) Available to all individuals in each classification in paragraph (a) of this section and available on a statewide basis. However, the plan may provide for variations in the income standard by political subdivision according to cost-of-living differences.
(a) In States using more restrictive eligibility requirements than SSI or in States that use SSI criteria but do not have section 1616 or 1634 agreements with the Social Security Administration for eligibility determinations, the agency may provide Medicaid to individuals specified in paragraph (b) of this section who receive only a State supplement if the State supplement meets the conditions specified in paragraph (c) of this section.
(b) The agency may provide Medicaid to all individuals receiving only State supplements if, except for their income, the individuals meet the more restrictive eligibility requirements under § 435.121 or SSI criteria, or to one or more of the following classifications of individuals who meet these criteria:
(1) All aged individuals.
(2) All blind individuals.
(3) All disabled individuals.
(4) Only aged individuals in domiciliary facilities or other group living arrangements as defined under SSI.
(5) Only blind individuals in domiciliary facilities or other group living arrangements as defined under SSI.
(6) Only disabled individuals in domiciliary facilities or other group living arrangements as defined under SSI.
(7) Individuals receiving a Federally-administered optional State supplement that meets the conditions specified in this section.
(8) Individuals in additional classifications specified by the Secretary.
(9) Reasonable groups of individuals, as specified by the State, receiving State-administered supplementary payments.
(c) Payments under the optional supplement program must be:
(1) Based on need and paid in cash on a regular basis;
(2) Equal to the difference between the individual's countable income and the income standard used to determine eligibility for supplements. Countable income is income remaining after deductions are applied. The income deductions may be more restrictive than required under SSI (see § 435.1006 for limitations on FFP in Medicaid expenditures for individuals receiving optional State supplements); and
(3) Available to all individuals in each classification in paragraph (b) of this section and available on a statewide basis. However, the plan may provide for variations in the income standard by political subdivision according to cost-of-living differences.
(a) If the agency provides Medicaid under § 435.211 to individuals in institutions who would be eligible for AFDC, SSI, or State supplements except for their institutional status, it may also cover aged, blind, and disabled individuals in institutions who—
(1) Because of their income, would not be eligible for SSI or State supplements if they were not institutionalized; but
(2) Have income below a level specified in the plan under § 435.722. (See § 435.1005 for limitations on FFP in Medicaid expenditures for individuals specified in this section.)
(b) The agency may cover individuals under this section whether or not the State pays optional supplements.
This subpart specifies the option for coverage of medically needy individuals.
(a) An agency may provide Medicaid to individuals specified in this subpart who:
(1) Either:
(i) Have income that meets the applicable standards in §§ 435.811 and 435.814; or
(ii) If their income is more than allowed under the standard, have incurred medical expenses at least equal to the difference between their income
(2) Have resources that meet the applicable standards in §§ 435.840 and 435.843.
(b) If the agency chooses this option, the following provisions apply:
(1) The agency must provide Medicaid to the following individuals who meet the requirements of paragraph (a) of this section:
(i) All pregnant women during the course of their pregnancy who, except for income and resources, would be eligible for Medicaid as mandatory or optional categorically needy under subparts B or C of this part;
(ii) All individuals under 18 years of age who, except for income and resources, would be eligible for Medicaid as mandatory categorically needy under subpart B of this part;
(iii) All newborn children born on or after October 1, 1984, to a woman who is eligible as medically needy and is receiving Medicaid on the date of the child's birth. The child is deemed to have applied and been found eligible for Medicaid on the date of birth and remains eligible as medically needy for one year so long as the woman remains eligible and the child is a member of the woman's household. If the woman's basis of eligibility changes to categorically needy, the child is eligible as categorically needy under § 435.117. The woman is considered to remain eligible if she meets the spend-down requirements in any consecutive budget period following the birth of the child.
(iv) Women who, while pregnant, applied for, were eligible for, and received Medicaid services as medically needy on the day that their pregnancy ends. The agency must provide medically needy eligibility to these women for an extended period following termination of pregnancy. This period extends from the last day of the pregnancy through the end of the month in which a 60-day period, beginning on the last day of pregnancy, ends. Eligibility must be provided, regardless of changes in the woman's financial circumstances that may occur within this extended period. These women are eligible for the extended period for all services under the plan that are pregnancy-related (as defined in § 440.210(c)(1) of this subchapter).
(2) The agency may provide Medicaid to any of the following groups of individuals;
(i) Individuals under age 21 (§ 435.308).
(ii) Specified relatives (§ 435.310).
(iii) Aged (§ 435.330.320 and 435.330).
(iv) Blind (§§ 435.322, 435.330 and 435.340).
(v) Disabled (§§ 435.324, 435.330, and 435.340).
(3) If the agency provides Medicaid to any individual in a group specified in paragraph (b)(2) of this section, the agency must provide Medicaid to all individuals eligible to be members of that group.
(a) If the agency provides Medicaid to the medically needy, it may provide Medicaid to individuals under age 21 (or, at State option, under age 20, 19, or 18), as specified in paragraph (b) of this section:
(1) Who would not be covered under the mandatory medically needy group of individuals under 18 under § 435.301(b)(1)(ii); and
(2) Who meet the income and resource requirements of subpart I of this part.
(b) The agency may cover all individuals described in paragraph (a) of this section or reasonable classifications of those individuals. Examples of reasonable classifications are as follows:
(1) Individuals in foster homes or private institutions for whom a public agency is assuming a full or partial financial responsibility. If the agency covers these individuals, it may also provide Medicaid to individuals placed in foster homes or private institutions by private nonprofit agencies.
(2) Individuals in adoptions subsidized in full or in part by a public agency.
(3) Individuals in nursing facilities when nursing facility services are provided under the plan to individuals within the age group selected under this provision. When the agency covers
(4) Individuals receiving active treatment as inpatients in psychiatric facilities or programs, if inpatient psychiatric services for individuals under 21 are provided under the plan.
(a) If the agency provides for the medically needy, it may provide Medicaid to specified relatives, as defined in paragraph (b) of this section, who meet the income and resource requirements of subpart I of this part.
(b)
(1) Are listed under section 406(b)(1) of the Act and 45 CFR 233.90(c)(1)(v)(A); and
(2) Have in their care an individual who is determined to be (or would, if needy, be) dependent, as specified in § 435.510.
If the agency provides Medicaid to individuals receiving SSI and elects to cover the medically needy, it may provide Medicaid to individuals who—
(a) Are 65 years of age and older, as specified in § 435.520; and
(b) Meet the income and resource requirements of subpart I of this part.
If the agency provides Medicaid to individuals receiving SSI and elects to cover the medically needy, it may provide Medicaid to blind individuals who meet—
(a) The requirements for blindness, as specified in §§ 435.530 and 435.531; and
(b) The income and resource requirements of subpart I of this part.
If the agency provides Medicaid to individuals receiving SSI and elects to cover the medically needy, it may provide Medicaid to disabled individuals who meet—
(a) The requirements for disability, as specified in §§ 435.540 and 435.541; and
(b) The income and resource requirements of Subpart I of this part.
If the agency provides Medicaid to the categorically needy under § 435.212, it may provide it under the same rules to medically needy recipients who are enrolled in MCOs or PCCMs.
(a) If an agency provides Medicaid as categorically needy only to those aged, blind, or disabled individuals who meet more restrictive requirements than used under SSI and elects to cover the medically needy, it may provide Medicaid as medically needy to those aged, blind, or disabled individuals who:
(1) Do not qualify for Medicaid as categorically needy under § 435.121 or § 435.230; and
(2) If applying as blind or disabled, meet the definition of blindness or disability established under § 435.121.
(b) Except as specified in paragraph (c) of this section, the agency must apply to individuals covered under the option of this section the same financial and nonfinancial requirements that are applied to individuals covered as categorically needy under §§ 435.121 and 435.230.
(c) In determining the financial eligibility of individuals who are considered as medically needy under this section, the agency must apply the financial
If an agency provides Medicaid to the medically needy, it must cover individuals who—
(a) Where eligible as medically needy under the Medicaid plan in December 1973 on the basis of the blindness or disability criteria of the AB, APTD, or AABD plan;
(b) For each consecutive month after December 1973, continue to meet—
(1) Those blindness or disability criteria; and
(2) The eligibility requirements for the medically needy under the December 1973 Medicaid plan; and
(c) Meet the current requirements for eligibility as medically needy under the Medicaid plan except for blindness or disability criteria.
If an agency provides Medicaid to the medically needy, it must provide the services necessary for the treatment of an emergency medical condition, as defined in § 440.255(c) of this chapter, to those aliens described in § 435.406(c) of this subpart.
This subpart prescribes general requirements for determining the eligibility of both categorically and medically needy individuals specified in subparts B, C, and D of this part.
(a) A Medicaid agency may not impose any eligibility requirement that is prohibited under Title XIX of the Act.
(b) The agency must base any optional group covered under subparts B and C of this part on reasonable classifications that do not result in arbitrary or inequitable treatment of individuals and groups and that are consistent with the objectives of Title XIX.
(c) The agency must not use requirements for determining eligibility for optional coverage groups that are—
(1) For families and children, more restrictive than those used under the State's AFDC plan; and
(2) For aged, blind, and disabled individuals, more restrictive than those used under SSI, except for individuals receiving an optional State supplement as specified in § 435.230 or individuals in categories specified by the agency under § 435.121.
(a)
(b)
(c)
(1) Has an I.Q. of 49 or less or has a mental age of 7 or less, based on tests acceptable to the mental retardation agency in the State:
(2) Is judged legally incompetent; or
(3) Is found incapable of indicating intent based on medical documentation obtained from a physician, psychologist, or other person licensed by the State in the field of mental retardation.
(d)
(1) Meets the conditions in paragraphs (e) through (i) of this section; or
(2) Meets the criteria specified in an interstate agreement under paragraph (k) of this section.
(e)
(2) Any action beyond providing information to the individual and the individual's family would constitute arranging or making a State placement. However, the following actions do not constitute State placement:
(i) Providing basic information to individuals about another State's Medicaid program, and information about the availability of health care services and facilities in another State.
(ii) Assisting an individual in locating an institution in another State, provided the individual is capable of indicating intent and independently decides to move.
(3) When a competent individual leaves the facility in which the individual is placed by a State, that individual's State of residence for Medicaid purposes is the State where the individual is physically located.
(4) Where a placement is initiated by a State because the State lacks a sufficient number of appropriate facilities to provide services to its residents, the State making the placement is the individual's State of residence for Medicaid purposes.
(f)
(g)
(h)
(2) For any individual not residing in an institution as defined in paragraph (b) whose Medicaid eligibility is based on blindness or disability, the State of residence is the State in which the individual is living.
(3) For any other non-institutionalized individual not subject to paragraph (h)(1) or (h)(2) of this section, the State of residence is determined in accordance with 45 CFR 233.40, the rules governing residence under the AFDC program.
(4) For any institutionalized individual who is neither married nor emancipated, the State of residence is—
(i) The parent's or legal guardian's State of residence at the time of placement (if a legal guardian has been appointed and parental rights are terminated, the State of residence of the guardian is used instead of the parent's); or
(ii) The current State of residence of the parent or legal guardian who files the application if the individual is institutionalized in that State (if a legal guardian has been appointed and parental rights are terminated, the State or residence of the guardian is used instead of the parent's).
(iii) The State of residence of the individual or party who files an application is used if the individual has been abandoned by his or her parent(s), does not have a legal guardian and is institutionalized in that State.
(i)
(i) Living with the intention to remain there permanently or for an indefinite period (or if incapable of stating intent, where the individual is living); or
(ii) Living and which the individual entered with a job commitment or seeking employment (whether or not currently employed).
(2) For any institutionalized individual who became incapable of indicating intent before age 21, the State of residence is—
(i) That of the parent applying for Medicaid on the individual's behalf, if the parents reside in separate States (if a legal guardian has been appointed and parental rights are terminated, the State of residence of the guardian is used instead of the parent's);
(ii) The parent's or legal guardian's State of residence at the time of placement (if a legal guardian has been appointed and parental rights are terminated, the State of residence of the guardian is used instead of the parent's); or
(iii) The current State of residence of the parent or legal guardian who files the application if the individual is institutionalized in that State (if a legal guardian has been appointed and parental rights are terminated, the State of residence of the guardian is used instead of the parent's).
(iv) The State of residence of the individual or party who files an application is used if the individual has been abandoned by his or her parent(s), does not have a legal guardian and is institutionalized in that State.
(3) For any institutionalized individual who became incapable of indicating intent at or after age 21, the State of residence is the State in which the individual is physically present, except where another State makes a placement.
(4) For any other institutionalized individual, the State of residence is the State where the individual is living with the intention to remain there permanently or for an indefinite period.
(j)
(2) The agency may not deny Medicaid eligibility to an individual in an institution, who satisfies the residency rules set forth in this section, on the grounds that the individual did not establish residence in the State before entering the institution.
(3) The agency may not deny or terminate a resident's Medicaid eligibility because of that person's temporary absence from the State if the person intends to return when the purpose of the absence has been accomplished, unless another State has determined that the person is a resident there for purposes of Medicaid.
(k)
(l)
(1) The agency must continue to provide Medicaid to that recipient from June 24, 1983 until July 5, 1984, unless it makes arrangements with another State of residence to provide Medicaid at an earlier date: and
(2) Those arrangements must not include provisions prohibited by paragraph (h) of this section.
(m)
The agency must allow an individual who would be eligible under more than one category to have his eligibility determined for the category he selects.
(a) The agency must provide Medicaid to otherwise eligible residents of the United States who are—
(1) Citizens: (i) Under a declaration required by section 1137(d) of the Act that the individual is a citizen or national of the United States; and
(ii) The individual has provided satisfactory documentary evidence of citizenship or national status, as described in § 435.407.
(iii) An individual for purposes of the declaration and citizenship documentation requirements discussed in paragraphs (a)(1)(i) and (a)(1)(ii) of this section includes both applicants and recipients under a section 1115 demonstration (including a family planning demonstration project) for which a State receives Federal financial participation in their expenditures, as though the expenditures were for medical assistance.
(iv) Individuals must declare their citizenship and the State must document the individual's citizenship in the individual's eligibility file on initial applications and initial redeterminations effective July 1, 2006.
(v) The following groups of individuals are exempt from the requirements in paragraph (a)(1)(ii) of this section:
(A) Individuals receiving SSI benefits under title XVI of the Act.
(B) Individuals entitled to or enrolled in any part of Medicare.
(C) Individuals receiving disability insurance benefits under section 223 of the Act or monthly benefits under section 202 of the Act, based on the individual's disability (as defined in section 223(d) of the Act).
(D) Individuals who are in foster care and who are assisted under Title IV-B of the Act, and individuals who are recipients of foster care maintenance or adoption assistance payments under Title IV-E of the Act.
(2)(i) Except as specified in 8 U.S.C. 1612(b)(1) (permitting States an option with respect to coverage of certain qualified aliens), qualified aliens as described in section 431 of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (8 U.S.C. 1641) (including qualified aliens subject to the 5-year bar) who have provided satisfactory documentary evidence of Qualified Alien status, which status has been verified with the Department of Homeland Security (DHS) under a declaration required by section 1137(d) of the Act that the applicant or recipient is an alien in a satisfactory immigration status.
(ii) The eligibility of qualified aliens who are subject to the 5-year bar in 8 U.S.C. 1613 is limited to the benefits described in paragraph (b) of this section.
(b) The agency must provide payment for the services described in § 440.255(c) of this chapter to residents of the State who otherwise meet the eligibility requirements of the State plan (except for receipt of AFDC, SSI, or State Supplementary payments) who are qualified aliens subject to the 5-year bar or who are non-qualified aliens who meet all Medicaid eligibility criteria, except non-qualified aliens need not present a social security number or document immigration status.
For purposes of this section, the term “citizenship” includes status as a “national of the United States” as defined by section 101(a)(22) of the Immigration and Nationality Act (8 U.S.C. 1101(a)(22)) to include both citizens of the United States and non-citizen nationals of the United States.
(a)
(1)
(2)
(3)
(4) A valid State-issued driver's license, but only if the State issuing the license requires proof of U.S. citizenship before issuance of such license or obtains a social security number from the applicant and verifies before certification that such number is valid and assigned to the applicant who is a citizen. (This provision is not effective until such time as a State makes providing evidence of citizenship a condition of issuing a driver's license and evidence that the license holder is a citizen is included on the license or in a system of records available to the Medicaid agency. The State must ensure that the process complies with this statutory provision in section 6036 of the Deficit Reduction Act of 2005. CMS will monitor compliance of States implementing this provision.).
(b)
(1) A U.S. public birth certificate showing birth in one of the 50 States, the District of Columbia, Puerto Rico (if born on or after January 13, 1941), Guam (on or after April 10, 1899), the Virgin Islands of the U.S. (on or after January 17, 1917), American Samoa, Swain's Island, or the Northern Mariana Islands (after November 4, 1986 (NMI local time)). A State, at its option, may use a cross match with a State vital statistics agency to document a birth record. The birth record document may be issued by the State, Commonwealth, Territory, or local jurisdiction. It must have been recorded before the person was 5 years of age. A delayed birth record document that is recorded at or after 5 years of age is considered fourth level evidence of citizenship. (
(i)
(A) Evidence of birth in Puerto Rico on or after April 11, 1899 and the applicant's statement that he or she was residing in the U.S., a U.S. possession, or Puerto Rico on January 13, 1941; or
(B) Evidence that the applicant was a Puerto Rican citizen and the applicant's statement that he or she was residing in Puerto Rico on March 1, 1917 and that he or she did not take an oath of allegiance to Spain.
(ii)
(A) Evidence of birth in the U.S. Virgin Islands, and the applicant's statement of residence in the U.S., a U.S. possession, or the U.S. Virgin Islands on February 25, 1927; or
(B) The applicant's statement indicating residence in the U.S. Virgin Islands as a Danish citizen on January 17, 1917 and residence in the U.S., a U.S. possession, or the U.S. Virgin Islands on February 25, 1927, and that he or she did not make a declaration to maintain Danish citizenship; or
(C) Evidence of birth in the U.S. Virgin Islands and the applicant's statement indicating residence in the U.S., a U.S. possession or Territory, or the Canal Zone on June 28, 1932.
(iii)
(A) Evidence of birth in the NMI, TTPI citizenship and residence in the NMI, the U.S., or a U.S. Territory or possession on November 3, 1986 NMI local time) and the applicant's statement that he or she did not owe allegiance to a foreign State on November 4, 1986 (NMI local time); or
(B) Evidence of TTPI citizenship, continuous residence in the NMI since before November 3, 1981 (NMI local
(C) Evidence of continuous domicile in the NMI since before January 1, 1974 and the applicant's statement that he or she did not owe allegiance to a foreign State on November 4, 1986 (NMI local time).
(D)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
(i) At least one parent of the child is a United States citizen by either birth or naturalization (as verified under the requirements of this Part);
(ii) The child is under the age of 18;
(iii) The child is residing in the United States in the legal and physical custody of the U.S. citizen parent;
(iv) The child was admitted to the United States for lawful permanent residence (as verified under the requirements of 8 U.S.C. 1641 pertaining to verification of qualified alien status); and
(v) If adopted, the child satisfies the requirements of section 101(b)(1) of the Immigration and Nationality Act (8 U.S.C. 1101(b)(1) pertaining to international adoptions (admission for lawful permanent residence as IR-3 (child adopted outside the United States)), or as IR-4 (child coming to the United States to be adopted) with final adoption having subsequently occurred).
(c)
(1)
(2)
(3)
(4)
(d)
(1)
(2)
(i) Seneca Indian tribal census.
(ii) Bureau of Indian Affairs tribal census records of the Navajo Indians.
(iii) U.S. State Vital Statistics official notification of birth registration.
(iv) A delayed U.S. public birth record that is recorded more than 5 years after the person's birth.
(v) Statement signed by the physician or midwife who was in attendance at the time of birth.
(vi) The Roll of Alaska Natives maintained by the Bureau of Indian Affairs.
(3)
(4)
Medical records generally show biographical information for the person including place of birth; the record can be used to establish U.S. citizenship when it shows a U.S. place of birth. (
(5)
(i) There must be at least two affidavits by two individuals who have personal knowledge of the event(s) establishing the applicant's or recipient's claim of citizenship (the two affidavits could be combined in a joint affidavit).
(ii) At least one of the individuals making the affidavit cannot be related to the applicant or recipient. Neither of the two individuals can be the applicant or recipient.
(iii) In order for the affidavit to be acceptable the persons making them must be able to provide proof of their own citizenship and identity.
(iv) If the individual(s) making the affidavit has (have) information which explains why documentary evidence establishing the applicant's claim or citizenship does not exist or cannot be readily obtained, the affidavit should contain this information as well.
(v) The State must obtain a separate affidavit from the applicant/recipient or other knowledgeable individual (guardian or representative) explaining why the evidence does not exist or cannot be obtained.
(vi) The affidavits must be signed under penalty of perjury and need not be notarized.
(e)
(1) Identity documents described in 8 CFR 274a.2(b)(1)(v)(B)(1).
(i) Driver's license issued by State or Territory either with a photograph of the individual or other identifying information of the individual such as
(ii) School identification card with a photograph of the individual.
(iii) U.S. military card or draft record.
(iv) Identification card issued by the Federal, State, or local government with the same information included on drivers' licenses.
(v) Military dependent's identification card.
(vi) Certificate of Degree of Indian Blood, or other American Indian/Alaska Native Tribal document with a photograph or other personal identifying information relating to the individual. Acceptable if the document carries a photograph of the applicant or recipient, or has other personal identifying information relating to the individual such as age, weight, height, race, sex, and eye color.
(vii) U.S. Coast Guard Merchant Mariner card.
Exception: Do not accept a voter's registration card or Canadian driver's license as listed in 8 CFR 274a.2(b)(1)(v)(B)(1). CMS does not view these as reliable for identity.
(2) At State option, a State may use a cross match with a Federal or State governmental, public assistance, law enforcement or corrections agency's data system to establish identity if the agency establishes and certifies true identity of individuals. Such agencies may include food stamps, child support, corrections, including juvenile detention, motor vehicle, or child protective services. The State Medicaid Agency is still responsible for assuring the accuracy of the identity determination.
(3) At State option, a State may accept three or more documents that together reasonably corroborate the identity of an individual provided such documents have not been used to establish the individual's citizenship and the individual submitted second or third tier evidence of citizenship. The State must first ensure that no other evidence of identity is available to the individual prior to accepting such documents. Such documents must at a minimum contain the individual's name, plus any additional information establishing the individual's identity. All documents used must contain consistent identifying information. These documents include employer identification cards, high school and college diplomas from accredited institutions (including general education and high school equivalency diplomas), marriage certificates, divorce decrees and property deeds/titles.
(f)
(g)
(h)
(i)
(2) States must maintain copies of citizenship and identification documents in the case record or electronic data base and make these copies available for compliance audits.
(3) States may permit applicants and recipients to submit such documentary evidence without appearing in person at a Medicaid office. States may accept original documents in person, by mail, or by a guardian or authorized representative.
(4) If documents are determined to be inconsistent with pre-existing information, are counterfeit, or altered, States should investigate for potential fraud and abuse, including but not limited to, referral to the appropriate State and Federal law enforcement agencies.
(5) Presentation of documentary evidence of citizenship is a one time activity; once a person's citizenship is documented and recorded in a State database subsequent changes in eligibility should not require repeating the documentation of citizenship unless later evidence raises a question of the person's citizenship. The State need only check its databases to verify that the individual already established citizenship.
(6) CMS requires that as a check against fraud, using currently available automated capabilities, States will conduct a match of the applicant's name against the corresponding Social Security number that was provided. In addition, in cooperation with other agencies of the Federal government, CMS encourages States to use automated capabilities to verify citizenship and identity of Medicaid applicants. Automated capabilities may fall within the computer matching provisions of the Privacy Act of 1974, and CMS will explore any implementation issues that may arise with respect to those requirements. When these capabilities become available, States will be required to match files for individuals who used third or fourth tier documents to verify citizenship and documents to verify identity, and CMS will make available to States necessary information in this regard. States must ensure that all case records within this category will be so identified and made available to conduct these automated matches. CMS may also require States to match files for individuals who used first or second level documents to verify citizenship as well. CMS may provide further guidance to States with respect to actions required in a case of a negative match.
(j)
(k)
This subpart prescribes categorical requirements for determining the eligibility of both categorically and medically needy individuals specified in subparts B, C, and D of this part.
For families with dependent children who are not receiving AFDC, the agency must use the definitions and procedures set forth under the State's AFDC plan to determine whether—
(a) An individual is a dependent child because he is deprived of parental support or care; and
(b) An individual is an eligible member of a family with dependent children.
The agency must not impose an age requirement of more than 65 years.
(a) Except as specified in paragraphs (b) and (c) of this section, in determining age, the agency must use the common-law method (under which an age reached the day before the anniversary of birth).
(b) For families and children, the agency must use the popular usage method (under which an age is reached on the anniversary of birth), if this method is used under the State's AFDC plan.
(c) For aged, blind, or disabled individuals, the agency must use the popular usage method, if the plan provides under § 435.121, § 435.230, or § 435.330, for coverage of aged, blind, or disabled individuals who meet more restrictive eligibility requirements than those under SSI.
(d) The agency may use an arbitrary date, such as July 1, for determining an individual's age if the year, but not the month, of his birth is known.
(a)
(1) In determining the eligibility of individuals whose Medicaid eligibility is protected under §§ 435.130 through 435.134, the agency must use the definition of blindness that was used under the Medicaid plan in December 1973; and
(2) The agency may use a more restrictive definition to determine eligibility under § 435.121, if the definition is no more restrictive than that used under the Medicaid plan on January 1, 1972.
(b)
(a) Except as specified in paragraph (b) of this section, in determining blindness—
(1) A physician skilled in the diseases of the eye or an optometrist, whichever the individual selects, must examine him, unless both of the applicant's eyes are missing;
(2) The examiner must submit a report of examination to the Medicaid agency; and
(3) A physician skilled in the diseases of the eye (for example, an ophthalmologist or an eye, ear, nose, and throat specialist) must review the report and determine on behalf of the agency—
(i) Whether the individual meets the definition of blindness; and
(ii) Whether and when re-examinations are necessary for periodic redeterminations of eligibility, as required under § 435.916 of this part.
(b) If an agency provides Medicaid to individuals receiving SSI on the basis of blindness, this section does not apply for those individuals.
(a)
(1) In determining the eligibility of individuals whose Medicaid eligibility is protected under §§ 435.130 through 435.134, the agency must use the definition of disability that was used under the Medicaid plan in December 1973; and
(2) The agency may use a more restrictive definition to determine eligibility under § 435.121, if the definition is no more restrictive than that used under the Medicaid plan on January 1, 1972.
(b)
(a)
(1) If the agency has an agreement with the Social Security Administration (SSA) under section 1634 of the Act, the agency may not make a determination of disability when the only application is filed with SSA.
(2) The agency may not make an independent determination of disability if SSA has made a disability determination within the time limits set forth in § 435.911 on the same issues presented in the Medicaid application. A determination of eligibility for SSI payments based on disability that is made by SSA automatically confers Medicaid eligibility, as provided for under § 435.909.
(b)
(i) An SSA disability determination is binding on an agency until the determination is changed by SSA.
(ii) If the SSA determination is changed, the new determination is also binding on the agency.
(2) The agency must refer to SSA all applicants who allege new information or evidence affecting previous SSA determinations of ineligibility based upon disability for reconsideration or reopening of the determination, except in cases specified in paragraph (c)(4) of this section.
(c)
(1) The individual applies for Medicaid as a non-cash recipient and has not applied to SSA for SSI cash benefits, whether or not a State has a section 1634 agreement with SSA; or an individual applies for Medicaid and has applied to SSA for SSI benefits and is found ineligible for SSI for a reason other than disability.
(2) The individual applies both to SSA for SSI and to the State Medicaid agency for Medicaid, the State agency has a section 1634 agreement with SSA, and SSA has not made an SSI disability determination within 90 days from the date of the individual's application for Medicaid.
(3) The individual applies to SSA for SSI and to the State Medicaid agency for Medicaid, the State does not have a section 1634 agreement with SSA, and either the State uses more restrictive criteria than SSI for determining Medicaid eligibility under its section 1902(f) option or, in the case of a State that uses SSI criteria, SSA has not made an SSI disability determination in time for the State to comply with the Medicaid time limit for making a prompt determination on an individual's application for Medicaid.
(4) The individual applies for Medicaid as a non-cash recipient, whether or not the State has a section 1634 agreement with SSA, and—
(i) Alleges a disabling condition different from, or in addition to, that considered by SSA in making its determination; or
(ii) Alleges more than 12 months after the most recent SSA determination denying disability that his or her condition has changed or deteriorated since that SSA determination and alleges a new period of disability which meets the durational requirements of the Act, and has not applied to SSA for a determination with respect to these allegations.
(iii) Alleges less than 12 months after the most recent SSA determination denying disability that his or her condition has changed or deteriorated since that SSA determination, alleges a new period of disability which meets the durational requirements of the Act, and—
(A) Has applied to SSA for reconsideration or reopening of its disability decision and SSA refused to consider the new allegations; and/or
(B) He or she no longer meets the nondisability requirements for SSI but may meet the State's nondisability requirements for Medicaid eligibility.
(d)
(1) On the basis of the evidence required under paragraph (e) of this section; and
(2) In accordance with the requirements for evaluating that evidence under the SSI program specified in 20 CFR 416.901 through 416.998.
(e)
(f)
(2)
(3)
This subpart prescribes:
(a) General financial requirements and options for determining the eligibility of both categorically and medically needy individuals specified in subparts B, C, and D of this part. Subparts H and I of this part prescribe additional financial requirements.
(b) [Reserved]
(a)
(b)
(c)
(d)
(i) Qualified pregnant women and children under the mandatory categorically needy group under § 435.116;
(ii) Low-income pregnant women, infants, and children specified in section 1902(a)(10)(i)(IV), 1902(a)(10)(A)(i)(VI), and 1902(a)(10)(A)(i)(VII) of the Act;
(iii) Qualified Medicare beneficiaries specified in sections 1902(a)(10)(E) and 1905(p) of the Act;
(iv) Optional categorically needy individuals under groups established under subpart C of this part and section 1902(a)(10)(A)(ii) of the Act;
(v) Medically needy individuals under groups established under subpart D of this part and section 1902(a)(10)(C)(i)(III) of the Act; and
(vi) Aged, blind, and disabled individuals in States using more restrictive eligibility requirements than SSI under groups established under §§ 435.121 and 435.230.
(2) The income and resource methodologies that an agency elects to apply to groups of individuals described in paragraph (d)(1) of this section may be less restrictive, but no more restrictive (except in States using more restrictive requirements than SSI), than:
(i) For groups of aged, blind, and disabled individuals, the SSI methodologies; or
(ii) For all other groups, the methodologies under the State plan most closely categorically related to the individual's status.
(3) A financial methodology is considered to be no more restrictive if, by using the methodology, additional individuals may be eligible for Medicaid and no individuals who are otherwise eligible are by use of that methodology made ineligible for Medicaid.
(4) The less restrictive methodology applied under this section must be comparable for all persons within each category of assistance (aged, or blind, or disabled, or AFDC related) within an eligibility group. For example, if the agency chooses to apply less restrictive income or resource methodology to an eligibility group of aged individuals, it must apply that methodology to all aged individuals within the selected group.
(5) The application of the less restrictive income and resource methodologies permitted under this section must be consistent with the limitations and conditions on FFP specified in subpart K of this part.
(e) [Reserved]
(f)
(2) If the agency chooses to apply less restrictive income and resource methodologies, the State plan must specify:
(i) The less restrictive methodologies that will be used; and
(ii) The eligibility group or groups to which the less restrictive methodologies will be applied.
(a)
(1) Except for a spouse of an individual or a parent for a child who is under age 21 or blind or disabled, the agency must not consider income and resources of any relative as available to an individual.
(2) In relation to individuals under age 21 (as described in section 1905(a)(i) of the Act), the financial responsibility requirements and methodologies that apply include considering the income and resources of parents or spouses whose income and resources would be considered if the individual under age 21 were dependent under the State's approved AFDC plan, whether or not they are actually contributed, except as specified under paragraphs (c) and (d) of this section. These requirements and methodologies must be applied in accordance with the provisions of the State's approved AFDC plan.
(3) When a couple ceases to live together, the agency must count only the income of the individual spouse in determining his or her eligibility, beginning the first month following the month the couple ceases to live together.
(4) In the case of eligible institutionalized spouses who are aged, blind, and disabled and who have shared the same room in a title XIX Medicaid institution, the agency has the option of considering these couples as eligible couples for purposes of counting income and resources or as eligible individuals, whichever is more advantageous to the couple.
(b)
(1) The requirements and methodologies for financial responsibility of relatives used under the SSI program; or
(2) More extensive requirements for relative responsibility than specified in § 435.602(a) but no more extensive than the requirements under the Medicaid plan in effect on January 1, 1972.
(c)
(d) [Reserved]
(a) As a condition of eligibility, the agency must require applicants and recipients to take all necessary steps to obtain any annuities, pensions, retirement, and disability benefits to which they are entitled, unless they can show good cause for not doing so.
(b) Annuities, pensions, retirement and disability benefits include, but are not limited to, veterans' compensation and pensions, OASDI benefits, railroad retirement benefits, and unemployment compensation.
(a) As a condition of eligibility, the agency must require legally able applicants and recipients to:
(1) Assign rights to the Medicaid agency to medical support and to payment for medical care from any third party;
(2) Cooperate with the agency in establishing paternity and in obtaining medical support and payments, unless the individual establishes good cause for not cooperating, and except for individuals described in section 1902 (1)(1)(A) of the Act (poverty level pregnant women), who are exempt from cooperating in establishing paternity and obtaining medical support and payments from, or derived from, the father of the child born out of wedlock; and
(3) Cooperate in identifying and providing information to assist the Medicaid agency in pursuing third parties who may be liable to pay for care and services under the plan, unless the individual establishes good cause for not cooperating.
(b) The requirements for assignment of rights must be applied uniformly for all groups covered under the plan.
(c) The requirements of paragraph (a) of this section for the assignment of rights to medical support and other payments and cooperation in obtaining medical support and payments are effective for medical assistance furnished on or after October 1, 1984. The requirement for cooperation in identifying and providing information for pursuing liable third parties is effective for medical assistance furnished on or after July 1, 1988.
(a) If an agency, under § 435.231, provides Medicaid to individuals in medical institutions, nursing facilities, and intermediate care facilities for the mentally retarded who would not be eligible for SSI or State supplements if they were not institutionalized, the agency must use income standards based on the greater need for financial assistance that the individuals would have if they were not in the institution. The standards may vary by the level of institutional care needed by the individual (hospital, nursing facility, or intermediate level care for the mentally retarded), or by other factors related to individual needs. (See § 435.1005 for FFP limits on income standards established under this section.)
(b) In determining the eligibility of individuals under the income standards established under this section, the agency must not take into account income that would be disregarded in determining eligibility for SSI or for an optional State supplement.
(c) The agency must apply the income standards established under this section effective with the first day of a period of not less than 30 consecutive days of institutionalization.
(a)
(b)
(2) Categorically needy eligibility in States that do not include the medically needy is determined in accordance with the provisions of § 435.121 (e)(4) and (e)(5).
In determining whether individuals continue to meet the income requirements used in December 1973, for purposes of determining eligibility under §§ 435.131, 435.132, and 435.133, the agency must deduct increased OASDI payments to the same extent that these deductions were in effect in December 1973. These deductions are required by section 306 of the Social Security Amendments of 1972 (Pub. L. 92-603) and section 1007 of Pub. L. 91-172 (enacted Dec. 30, 1969), modified by section 304 of Pub. L. 92-603.
This subpart prescribes specific financial requirements for determining the post-eligibility treatment of income of categorically needy individuals, including requirements for applying patient income to the cost of care.
(a)
(2) The individual's income must be determined in accordance with paragraph (e) of this section.
(3) Medical expenses must be determined in accordance with paragraph (f) of this section.
(b)
(1) Individuals receiving cash assistance under SSI or AFDC who are eligible for Medicaid under § 435.110 or § 435.120.
(2) Individuals who would be eligible for AFDC, SSI, or an optional State supplement except for their institutional status and who are eligible for Medicaid under § 435.211.
(3) Aged, blind, and disabled individuals who are eligible for Medicaid, under § 435.231, under a higher income standard than the standard used in determining eligibility for SSI or optional State supplements.
(c)
(1)
(i) $30 a month for an aged, blind, or disabled individual, including a child applying for Medicaid on the basis of blindness or disability;
(ii) $60 a month for an institutionalized couple if both spouses are aged, blind, or disabled and their income is considered available to each other in determining eligibility; and
(iii) For other individuals, a reasonable amount set by the agency, based on a reasonable difference in their personal needs from those of the aged, blind, and disabled.
(2)
(i) The amount of the income standard used to determine eligibility for SSI for an individual living in his own home, if the agency provides Medicaid only to individuals receiving SSI;
(ii) The amount of the highest income standard, in the appropriate category of age, blindness, or disability, used to determine eligibility for an optional State supplement for an individual in his own home, if the agency provides Medicaid to optional State supplement recipients under § 435.230; or
(iii) The amount of the medically needy income standard for one person established under § 435.811, if the agency provides Medicaid under the medically needy coverage option.
(3)
(i) Be based on a reasonable assessment of their financial need;
(ii) Be adjusted for the number of family members living in the home; and
(iii) Not exceed the higher of the need standard for a family of the same size used to determine eligibility under the State's approved AFDC plan or the medically needy income standard established under § 435.811, if the agency provides Medicaid under the medically needy coverage option for a family of the same size.
(4)
(i) Medicare and other health insurance premiums, deductibles, or coinsurance charges; and
(ii) Necessary medical or remedial care recognized under State law but not covered under the State's Medicaid plan, subject to reasonable limits the agency may establish on amounts of these expenses.
(5)
(d)
(1) The amount is deducted for not more than a 6-month period; and
(2) A physician has certified that either of the individuals is likely to return to the home within that period.
(3) For single individuals and couples, an amount (in addition to the personal needs allowance) for maintenance of the individual's or couple's home if—
(i) The amount is deducted for not more than a 6-month period; and
(ii) A physician has certified that either of the individuals is likely to return to the home within that period.
(e)
(2)
(3)
(f)
(2)
(3)
(a) The agency must reduce its payment for home and community-based services provided to an individual specified in paragraph (b) of this section, by the amount that remains after deducting the amounts specified in paragraph (c) of this section from the individual's income.
(b) This section applies to individuals who are eligible for Medicaid under § 435.217 and are receiving home and community-based services furnished under a waiver of Medicaid requirements specified in part 441, subpart G or H of this subchapter.
(c) In reducing its payment for home and community-based services, the agency must deduct the following amounts, in the following order, from the individual's total income (including amounts disregarded in determining eligibility):
(1) An amount for the maintenance needs of the individual that the State may set at any level, as long as the following conditions are met:
(i) The deduction amount is based on a reasonable assessment of need.
(ii) The State establishes a maximum deduction amount that will not be exceeded for any individual under the waiver.
(2) For an individual with only a spouse at home, an additional amount for the maintenance needs of the spouse. This amount must be based on a reasonable assessment of need but must not exceed the highest of—
(i) The amount of the income standard used to determine eligibility for SSI for an individual living in his own home, if the agency provides Medicaid only to individuals receiving SSI;
(ii) The amount of the highest income standard, in the appropriate category of age, blindness, or disability, used to determine eligibility for an optional State supplement for an individual in his own home, if the agency provides Medicaid to optional State supplement recipients under § 435.230; or
(iii) The amount of the medically needy income standard for one person established under §§ 435.811 and 435.814, if the agency provides Medicaid under the medically needy coverage option.
(3) For an individual with a family at home, an additional amount for the maintenance needs of the family. This amount must—
(i) Be based on a reasonable assessment of their financial need;
(ii) Be adjusted for the number of family members living in the home; and
(iii) Not exceed the higher of the need standard for a family of the same size used to determine eligibility under the State's AFDC plan or the medically needy income standard established under § 435.811 for a family of the same size.
(4) Amounts for incurred expenses for medical or remedial care that are not subject to payment by a third party including—
(i) Medicare and other health insurance premiums, deductibles, or coinsurance charges; and
(ii) Necessary medical or remedial care recognized under State law but not covered under the State's Medicaid plan, subject to reasonable limits the agency may establish on amounts of these expenses.
(a)
(2) The individual's income must be determined in accordance with paragraph (e) of this section.
(3) Medical expenses must be determined in accordance with paragraph (f) of this section.
(b)
(1) Individuals receiving cash assistance under AFDC who are eligible for Medicaid under § 435.110 and individuals eligible under § 435.121.
(2) Individuals who would be eligible for AFDC, SSI, or an optional State supplement except for their institutional status and who are eligible for Medicaid under § 435.211.
(3) Aged, blind, and disabled individuals who are eligible for Medicaid, under § 435.231, under a higher income standard than the standard used in determining eligibility for SSI or optional State supplements.
(c)
(1)
(i) $30 a month for an aged, blind, or disabled individual, including a child applying for Medicaid on the basis of blindness or disability;
(ii) $60 a month for an institutionalized couple if both spouses are aged, blind, or disabled and their income is considered available to each other in determining eligibility; and
(iii) For other individuals, a reasonable amount set by the agency, based on a reasonable difference in their personal needs from those of the aged, blind, and disabled.
(2)
(i) The more restrictive income standard established under § 435.121; or
(ii) The amount of the medically needy income standard for one person established under § 435.811, if the agency provides Medicaid under the medically needy coverage option.
(3)
(i) Be based on a reasonable assessment of their financial need;
(ii) Be adjusted for the number of family members living in the home; and
(iii) Not exceed the higher of the need standard for a family of the same size used to determine eligibility under the State's approved AFDC plan or the medically needy income standard established under § 435.811, if the agency provides Medicaid under the medically needy coverage option for a family of the same size.
(4)
(i) Medicare and other health insurance permiums, deductibles, or coinsurance charges; and
(ii) Necessary medical or remedial care recognized under State law but not covered under the State's Medicaid plan, subject to reasonable limits the agency may establish on amounts of these expenses.
(5)
(d)
(1) The amount is deducted for not more than a 6-month period; and
(2) A physician has certified that either of the individuals is likely to return to the home within that period.
(e)
(2)
(3)
(f)
(2)
(3)
(a) The agency must reduce its payment for home and community-based services provided to an individual specified in paragraph (b) of this section, by the amount that remains after deducting the amounts specified in paragraph (c) of this section from the individual's income.
(b) This section applies to individuals who are eligible for Medicaid under § 435.217, and are eligible for home and community-based services furnished under a waiver of State plan requirements specified in part 441, subpart G or H of this subchapter.
(c) In reducing its payment for home and community-based services, the agency must deduct the following amounts, in the following order, from the individual's total income (including amounts disregarded in determining eligibility):
(1) An amount for the maintenance needs of the individual that the State may set at any level, as long as the following conditions are met:
(i) The deduction amount is based on a reasonable assessment of need.
(ii) The State establishes a maximum deduction amount that will not be exceeded for any individual under the waiver.
(2) For an individual with only a spouse at home, an additional amount for the maintenance needs of the spouse. This amount must be based on a reasonable assessment of need but must not exceed the higher of—
(i) The more restrictive income standard established under § 435.121; or
(ii) The medically needy standard for an individual.
(3) For an individual with a family at home, an additional amount for the maintenance needs of the family. This amount must—
(i) Be based on a reasonable assessment of their financial need;
(ii) Be adjusted for the number of family members living in the home; and
(iii) Not exceed the higher of the need standard for a family of the same size used to determine eligibility under the State's approved AFDC plan or the medically needy income standard established under § 435.811 for a family of the same size.
(4) Amounts for incurred expenses for medical or remedial care that are not subject to payment by a third party, including—
(i) Medicare and other health insurance premiums, deductibles, or coinsurance charges; and
(ii) Necessary medical or remedial care recognized under State law but not covered under the State's Medicaid plan, subject to reasonable limits the agency may establish on amounts of these expenses.
This subpart prescribes specific financial requirements for determining the eligibility of medically needy individuals under subpart D of this part.
(a) Except as provided in paragraph (d)(2) of this section, to determine eligibility of medically needy individuals, a Medicaid agency must use a single income standard under this subpart that meets the requirements of this section.
(b) The income standard must take into account the number of persons in the assistance unit. Subject to the limitations specified in paragraph (e) of this section. The standard may not diminish by an increase in the number of persons in the assistance unit. For example, if the income level in the standard for an assistance unit of two is set at $400, the income level in the standard for an assistance unit of three may not be less than $400.
(c) In States that do not use more restrictive requirements than SSI, the income standard must be set at an amount that is no lower than the lowest income standards used under the cash assistance programs that are related to the State's covered medically needy eligibility group or groups of individuals under § 435.301. The amount of the income standard is subject to the limitations specified in paragraph (e) of this section.
(d) In States that use more restrictive requirements for aged, blind, and disabled individuals than SSI:
(1) For all individuals except aged, blind, and disabled individuals, the income standard must be set in accordance with paragraph (c) of this section; and
(2) For all aged, blind, and disabled individuals or any combination of these groups of individuals, the agency may establish a separate single medically needy income standard that is more restrictive than the single income standard set under paragraph (c) of this section. However, the amount of the more restrictive separate standard for aged, blind, or disabled individuals must be no lower than the higher of the lowest categorically needy income standard currently applied under the
(e) The income standards specified in paragraphs (c) and (d) of this section must not exceed the maximum dollar amount of income allowed for purposes of FFP under § 435.1007.
(f) The income standard may vary based on the variations between shelter costs in urban areas and rural areas.
The State plan must specify the income standard for the covered medically needy groups.
The agency must determine income eligibility of medically needy individuals in accordance with this section.
(a)
(2) The agency may include in the budget period in which income is computed all or part of the 3-month retroactive period specified in § 435.914. The budget period can begin no earlier than the first month in the retroactive period in which the individual received covered services. This provision applies to all medically needy individuals except in groups for whom criteria more restrictive than that used in the SSI program apply.
(3) If the agency elects to begin the first budget period for the medically needy in any month of the 3-month period prior to the date of the application in which the applicant received covered services, this election applies to all medically needy groups.
(b)
(1) For individuals under age 21 and caretaker relatives, the agency must deduct amounts that would be deducted in determining eligibility under the State's AFDC plan.
(2) For aged, blind, or disabled individuals in States covering all SSI recipients, the agency must deduct amounts that would be deducted in determining eligibility under SSI. However, the agency must also deduct the highest amounts from income that would be deducted in determining eligibility for optional State supplements if these supplements are paid to all individuals who are receiving SSI or would be eligible for SSI except for their income.
(3) For aged, blind, or disabled individuals in States using income requirements more restrictive than SSI, the agency must deduct amounts that are no more restrictive than those used under the Medicaid plan on January 1, 1972 and no more liberal than those used in determining eligibility under SSI or an optional State supplement. However, the amounts must be at least the same as those that would be deducted in determining eligibility, under § 435.121, of the categorically needy.
(c)
(d)
(e)
(1) Expenses for Medicare and other health insurance premiums, and deductibles or coinsurance charges, including enrollment fees, copayments, or deductibles imposed under § 447.51 or § 447.53 of this subchapter;
(2) Expenses incurred by the individual or family or financially responsible relatives for necessary medical and remedial services that are recognized under State law but not included in the plan;
(3) Expenses incurred by the individual or family or by financially responsible relatives for necessary medical and remedial services that are included in the plan, including those that exceed agency limitations on amount, duration, or scope of services.
(f)
(1) For the first budget period or periods that include only months before the month of application for medical assistance, expenses incurred during such period or periods, whether paid or unpaid, to the extent that the expenses have not been deducted previously in establishing eligibility;
(2) For the first prospective budget period that also includes any of the 3 months before the month of application for medical assistance, expenses incurred during such budget period, whether paid or unpaid, to the extent that the expenses have not been deducted previously in establishing eligibility;
(3) For the first prospective budget period that includes none of the months preceding the month of application, expenses incurred during such budget period and any of the 3 preceding months, whether paid or unpaid, to the extent that the expenses have not been deducted previously in establishing eligibility;
(4) For any of the 3 months preceding the month of application that are not includable under paragraph (f)(2) of this section, expenses incurred in the 3-month period that were a current liability of the individual in any such month for which a spenddown calculation is made and that had not been previously deducted from income in establishing eligibility for medical assistance;
(5) Current payments (that is, payments made in the current budget period) on other expenses incurred before the current budget period and not previously deducted from income in any budget period in establishing eligibility for such period; and
(6) If the individual's eligibility for medical assistance was established in each such preceding period, expenses incurred before the current budget period but not previously deducted from income in establishing eligibility, to the extent that such expenses are unpaid and are:
(i) Described in paragraphs (e)(1) through (e)(3) of this section; and
(ii) Carried over from the preceding budget period or periods because the individual had a spenddown liability in each such preceding period that was met without deducting all such incurred, unpaid expenses.
(g)
(1) May include medical institutional expenses (other than expenses in acute care facilities) projected to the end of the budget period at the Medicaid reimbursement rate;
(2) May, to the extent determined by the State and specified in its approved plan, include expenses incurred earlier than the third month before the month of application (except States using more restrictive eligibility criteria under the option in section 1902(f) of the Act must deduct incurred expenses regardless of when the expenses were incurred); and
(3) May set reasonable limits on the amount to be deducted for expenses specified in paragraphs (e)(1), (e)(2), and (g)(2) of this section.
(h)
(1)
(i) Cost-sharing expenses as specified in paragraph (e)(1) of this section.
(ii) Services not included in the State plan as specified in paragraph (e)(2) of this section.
(iii) Services included in the State plan as specified in paragraph (e)(3) of this section but that exceed limitations on amounts, duration, or scope of services.
(iv) Services included in the State plan as specified in paragraph (e)(3) of this section but that are within agency limitations on amount, duration, or scope of services.
(2)
(3)
(i)
(i) If his or her spenddown liability is met after the first day of the budget period; and
(ii) If beginning eligibility after the first day of the budget period makes the individual's share of health care expenses under §§ 435.725, 435.726, 435.733, 435.735 or 435.832 greater than the individual's contributable income determined under these sections.
(2) At the end of the prospective period specified in paragraphs (f)(2) and (f)(3) of this section, and any subsequent prospective period or, if earlier, when any significant change occurs, the agency must reconcile the projected amounts with the actual amounts incurred, or with changes in circumstances, to determine if the adjusted deduction of incurred expenses reduces income to the income standard.
(3) Except as provided in paragraph (i)(1) of this section, in States that elect partial month coverage, an individual is eligible for Medicaid on the day that the deduction of incurred health care expenses (and of projected institutional expenses if the agency elects the option under paragraph (g)(1) of this section) reduces income to the income standard.
(4) Except as provided in paragraph (i)(1) of this section, in States that elect full month coverage, an individual is eligible on the first day of the month in which spenddown liability is met.
(5) Expenses used to meet spenddown liability are not reimbursable under Medicaid. To the extent necessary to prevent the transfer of an individual's spenddown liability to the Medicaid program, States must reduce the amount of provider charges that would otherwise be reimbursable under Medicaid.
(a)
(2) The individual's income must be determined in accordance with paragraph (e) of this section.
(3) Medical expenses must be determined in accordance with paragraph (f) of this section.
(b)
(c)
(1)
(i) $30 a month for an aged, blind, or disabled individual, including a child applying for Medicaid on the basis of blindness or diability.
(ii) $60 a month for an institutionalized couple if both spouses are aged, blind, or disabled and their income is considered available to each other in determining eligibility; and
(iii) For other individuals, a reasonable amount set by the agency, based on a reasonable difference in their personal needs from those of the aged, blind, and disabled.
(2)
(i) The amount of the income standard used to determine eligibility for SSI for an individual living in his own home;
(ii) The amount of the highest income standard, in the appropriate category of age, blindness, or disability, used to determine eligibility for an optional State supplement for an individual in his own home, if the agency provides Medicaid to optional State supplement recipients under § 435.230; or
(iii) The amount of the medically needy income standard for one person established under § 435.811.
(3)
(i) Be based on a reasonable assessment of their financial need;
(ii) Be adjusted for the number of family members living in the home; and
(iii) Not exceed the highest of the following need standards for a family of the same size:
(A) The standard used to determine eligibility under the State's approved AFDC plan.
(B) The medically needy income standard established under § 435.811.
(4) Expenses not subject to third party payment. Amounts for incurred expenses for medical or remedial care that are not subject to payment by a third party, including—
(i) Medicare and other health insurance permiums, deductibles, or coinsurance charges; and
(ii) Necessary medical or remedial care recognized under State law but not covered under the State's Medicaid plan, subject to reasonable limits the agency may establish on amounts of these expenses.
(d)
(1) The amount is deducted for not more than a 6-month period; and
(2) A physician has certified that either of the individuals is likely to return to the home within that period.
(e)
(2)
(3)
(f)
(2)
(3)
(a) To determine eligibility of medically needy individuals, a Medicaid agency must use a single resource standard that meets the requirements of this section.
(b) In States that do not use more restrictive criteria than SSI for aged, blind, and disabled individuals, the resource standard must be established at an amount that is no lower than the lowest resource standard used under the cash assistance programs that relate to the State's covered medically needy eligibility group or groups of individuals under § 435.301.
(c) In States using more restrictive requirements than SSI:
(1) For all individuals except aged, blind, and disabled individuals, the resource standard must be set in accordance with paragraph (b) of this section; and
(2) For all aged, blind, and disabled individuals or any combination of these groups of individuals, the agency may establish a separate single medically needy resource standard that is more restrictive than the single resource standard set under paragraph (b) of this section. However, the amount of the more restrictive separate standard for aged, blind, or disabled individuals must be no lower than the higher of the lowest categorically needy resource standard currently applied under the State's more restrictive criteria under § 435.121 or the medically needy resource standard in effect under the State's Medicaid plan on January 1, 1972.
(d) The resource standard established under paragraph (a) of this section may not diminish by an increase in the number of persons in the assistance unit. For example, the resource standard for an assistance unit of three may not be less than that set for a unit of two.
The State plan must specify the resource standard for the covered medically needy groups.
To determine eligibility on the basis of resources for medically needy individuals, the agency must:
(a) Consider only the individual's resources and those that are considered available to him under the financial responsibility requirements for relatives in § 435.602.
(b) Deduct the amounts that would be deducted in determining resource eligibility for the medically needy group as provided for in § 435.601 or under the criteria of States using more restrictive criteria than SSI as provided for in § 435.121. In determining the amount of an individual's resources for Medicaid eligibility, States must count amounts of resources that otherwise would not be counted under the conditional eligibility provisions of the SSI or AFDC programs.
(c) Apply the resource standard specified under § 435.840.
This subpart sets forth requirements for processing applications, determining eligibility, and furnishing Medicaid.
The Medicaid agency's standards and methods for determining eligibility must be consistent with the objectives of the program and with the rights of individuals under the United States Constitution, the Social Security Act, title VI of the Civil Rights Act of 1964, section 504 of the Rehabilitation Act of 1973, and all other relevant provisions of Federal and State laws.
The agency's policies and procedures must ensure that eligibility is determined in a manner consistent with simplicity of administration and the best interests of the applicant or recipient.
The agency must—
(a) Have methods to keep itself currently informed of the adherence of local agencies to the State plan provisions and the agency's procedures for determining eligibility; and
(b) Take corrective action to ensure their adherence.
(a)
(b)
(1) The groups of pregnant women or infants with incomes up to 133 percent of the Federal poverty level as specified under section 1902(a)(10)(A)(i)(IV) of the Act;
(2) The group of children age 1 up to age 6 with incomes at 133 percent of the Federal poverty level as specified under section 1902(a)(10)(A)(i)(VI) of the Act;
(3) The group of children age 6 up to age 19 born after September 30, 1983, with incomes up to 100 percent of the Federal poverty level as specified under section 1902(a)(10)(A)(i)(VII) of the Act; and
(4) The groups of pregnant women or infants, children age 1 up to age 6, and children age 6 up to age 19, who are not eligible as a mandatory group, with incomes up to 185 percent of the Federal poverty level as specified under section 1902(a)(10)(A)(ii)(IX) of the Act.
(c)
(i) Outstation locations at each disproportionate share hospital, as defined in section 1923(a)(1)(A) of the Act, and each Federally-qualified health center, as defined in section 1905(1)(2)(B) of the Act, participating in the Medicaid program and providing services to Medicaid-eligible pregnant women and children; or
(ii) Other outstation locations, which include at least some, disproportionate share hospitals and federally-qualified health centers, as specified under an alternative State plan that is submitted to and approved by CMS if the following conditions are met:
(A) The State must demonstrate that the alternative plan for outstationing
(B) The State must provide assurances that the level of staffing and funding committed by the State under the alternative plan equals or exceeds the level of staffing and funding under a plan that would meet the requirements of establishing the outstation locations at the sites specified in paragraph (c)(1)(i) of this section.
(2) The agency must establish outstation locations at Indian health clinics operated by a tribe or tribal organization as these clinics are specifically included in the definition of Federally-qualified health centers under section 1905(l)(2)(B) of the Act and are also included in the definition of rural health clinics under part 491, subpart A of this chapter.
(3) The agency may establish additional outstation locations at any other site where potentially eligible pregnant women or children receive services—for example, at school-linked service centers and family support centers. These additional sites may also include sites other than the main outstation location of those Federally-qualified health centers or disproportionate share hospitals providing services to Medicaid-eligible pregnant women and to children and that operate more than one site.
(4) The agency may, at its option, enter into reciprocal agreements with neighboring States to ensure that the groups described in paragraph (b) of this section who customarily receive services in a neighboring State have the opportunity to apply at outstation locations specified in paragraphs (c)(l) and (2) of this section.
(d)
(2) “Initial processing” means taking applications, assisting applicants in completing the application, providing information and referrals, obtaining required documentation to complete processing of the application, assuring that the information contained on the application form is complete, and conducting any necessary interviews. It does not include evaluating the information contained on the application and the supporting documentation nor making a determination of eligibility or ineligibility.
(3) The agency may, at its option, allow appropriate State eligibility workers assigned to outstation locations to evaluate the information contained on the application and the supporting documentation and make a determination of eligibility if the workers are authorized to determine eligibility for the agency which determines Medicaid eligibility under § 431.10 of this subchapter.
(e)
(2) The agency may station staff at one outstation location or rotate staff among several locations as workload and staffing availability dictate.
(3) The agency may use State employees, provider or contractor employees, or volunteers who have been properly trained to staff outstation locations under the following conditions:
(i) State outstation intake staff may perform all eligibility processing functions, including the eligibility determination, if the staff is authorized to do so at the regular Medicaid intake office.
(ii) Provider or contractor employees and volunteers may perform only initial processing functions as defined in paragraph (d)(2) of this section.
(4) Provider and contractor employees and volunteers are subject to the confidentiality of information rules specified in part 431, subpart F, of this subchapter, to the prohibition against reassignment of provider claims specified in § 447.10 of this subchapter, and to all other State or Federal laws concerning conflicts of interest.
(5) At locations that are infrequently used by the designated low-income eligibility groups, the State agency may use volunteers, provider or contractor employees, or its own eligibility staff, or telephone assistance.
(i) The agency must display a notice in a prominent place at the outstation location advising potential applicants of when outstation intake workers will be available.
(ii) The notice must include a telephone number that applicants may call for assistance.
(iii) The agency must comply with Federal and State laws and regulations governing the provision of adequate notice to persons who are blind or deaf or who are unable to read or understand the English language.
(a) The agency must furnish the following information in written form, and orally as appropriate, to all applicants and to all other individuals who request it:
(1) The eligibility requirements.
(2) Available Medicaid services.
(3) The rights and responsibilities of applicants and recipients.
(b) The agency must publish in quantity and make available bulletins or pamphlets that explain the rules governing eligibility and appeals in simple and understandable terms.
The agency must afford an individual wishing to do so the opportunity to apply for Medicaid without delay.
(a) The agency must require a written application from the applicant, an authorized representative, or, if the applicant is incompetent or incapacitated, someone acting responsibly for the applicant.
(b) Subject to the conditions specified in paragraph (c) of this section, the application must be on a form prescribed by the agency and signed under a penalty of perjury.
(c) The application form used at outstation locations for low-income pregnant women, infants, and children specified in § 435.904 must not be the application form used to apply for AFDC. The application form (including any computerized application form) for these designated eligibility groups may be—
(1) A Medicaid-only form prescribed by the agency specifically for the designated eligibility groups;
(2) An existing Medicaid-only application; or
(3) A multiple-program application that contains clearly identifiable Medicaid-only sections or parts.
The agency must allow an individual or individuals of the applicant's choice to accompany, assist, and represent the applicant in the application process or a redetermination of eligibility.
The agency must not require a separate application for Medicaid from an individual, if—
(a) The individual receives AFDC; or
(b) The agency has an agreement with the Social Security Administration (SSA) under section 1634 of the Act for determining Medicaid eligibility; and—
(1) The individual receives SSI;
(2) The individual receives a mandatory State supplement under either a federally-administered or State-administered program; or
(3) The individual receives an optional State supplement and the agency provides Medicaid to recipients of optional supplements under § 435.230.
(a) The agency must require, as a condition of eligibility, that each individual (including children) requesting Medicaid services furnish each of his or her social security numbers (SSNs).
(b) The agency must advise the applicant of—
(1) [Reserved]
(2) The statute or other authority under which the agency is requesting the applicant's SSN; and
(3) The uses the agency will make of each SSN, including its use for verifying income, eligibility, and amount of medical assistance payments under §§ 435.940 through 435.960.
(c)-(d) [Reserved]
(e) If an applicant cannot recall his SSN or SSNs or has not been issued a SSN the agency must—
(1) Assist the applicant in completing an application for an SSN;
(2) Obtain evidence required under SSA regulations to establish the age, the citizenship or alien status, and the true identity of the applicant; and
(3) Either send the application to SSA or, if there is evidence that the applicant has previously been issued a SSN, request SSA to furnish the number.
(f) The agency must not deny or delay services to an otherwise eligible applicant pending issuance or verification of the individual's SSN by SSA.
(g) The agency must verify each SSN of each applicant and recipient with SSA, as prescribed by the Commissioner, to insure that each SSN furnished was issued to that individual, and to determine whether any others were issued.
(h)
(2) The term
(i) Is a member of a recognized religious sect or division of the sect; and
(ii) Adheres to the tenets or teachings of the sect or division of the sect and for that reason is conscientiously opposed to applying for or using a national identification number.
(3) A State may use the Medicaid identification number established by the State to the same extent as an SSN is used for purposes described in paragraph (b)(3) of this section.
(a) The agency must establish time standards for determining eligibility and inform the applicant of what they are. These standards may not exceed—
(1) Ninety days for applicants who apply for Medicaid on the basis of disability; and
(2) Forty-five days for all other applicants.
(b) The time standards must cover the period from the date of application to the date the agency mails notice of its decision to the applicant.
(c) The agency must determine eligibility within the standards except in unusual circumstances, for example—
(1) When the agency cannot reach a decision because the applicant or an examining physician delays or fails to take a required action, or
(2) When there is an administrative or other emergency beyond the agency's control.
(d) The agency must document the reasons for delay in the applicant's case record.
(e) The agency must not use the time standards—
(1) As a waiting period before determining eligibility; or
(2) As a reason for denying eligibility (because it has not determined eligibility within the time standards).
The agency must send each applicant a written notice of the agency's decision on his application, and, if eligibility is denied, the reasons for the action, the specific regulation supporting the action, and an explanation of his right to request a hearing. (See subpart
(a) The agency must include in each applicant's case record facts to support the agency's decision on his application.
(b) The agency must dispose of each application by a finding of eligibility or ineligibility, unless—
(1) There is an entry in the case record that the applicant voluntarily withdrew the application, and that the agency sent a notice confirming his decision;
(2) There is a supporting entry in the case record that the applicant has died; or
(3) There is a supporting entry in the case record that the applicant cannot be located.
(a) The agency must make eligibility for Medicaid effective no later than the third month before the month of application if the individual—
(1) Received Medicaid services, at any time during that period, of a type covered under the plan; and
(2) Would have been eligible for Medicaid at the time he received the services if he had applied (or someone had applied for him), regardless of whether the individual is alive when application for Medicaid is made.
(b) The agency may make eligiblity for Medicaid effective on the first day of a month if an individual was eligible at any time during that month.
(c) The State plan must specify the date on which eligibility will be made effective.
(a) The agency must redetermine the eligibility of Medicaid recipients, with respect to circumstances that may change, at least every 12 months, however—
(1) The agency may consider blindness as continuing until the review physician under § 435.531 determines that a recipient's vision has improved beyond the definition of blindness contained in the plan; and
(2) The agency may consider disability as continuing until the review team under § 435.541 determines that a recipient's disability no longer meets the definition of disability contained in the plan.
(b)
(c)
(2) If the agency has information about anticipated changes in a recipient's circumstances, it must redetermine eligibility at the appropriate time based on those changes.
(a) The agency must give recipients timely and adequate notice of proposed action to terminate, discontinue, or suspend their eligibility or to reduce or discontinue services they may receive under Medicaid.
(b) The notice must meet the requirements of subpart E of part 431 of this subchapter.
(a) In redetermining eligibility, the agency must review case records to determine whether they contain the recipient's SSN or, in the case of families, each family member's SSN.
(b) If the case record does not contain the required SSNs, the agency must require the recipient to furnish them and meet other requirements of § 435.910.
(c) For any recipient whose SSN was established as part of the case record without evidence required under the SSA regulations as to age, citizenship,
The agency must—
(a) Furnish Medicaid promptly to recipients without any delay caused by the agency's administrative procedures;
(b) Continue to furnish Medicaid regularly to all eligible individuals until they are found to be ineligible; and
(c) Make arrangements to assist applicants and recipients to get emergency medical care whenever needed, 24 hours a day and 7 days a week.
(a) Section 1137 of the Act requires certain Federally-funded, State-administered public assistance programs to establish procedures for obtaining, using and verifying information relevant to determinations as to eligibility and the amount of assistance. Section 1902(a)(4) of the Act allows the Secretary to prescribe methods of administration found necessary for the proper and efficient operation of a State's Medicaid plan.
(b) The agency must maintain information, as enumerated in § 435.960, to exchange for the purpose of enabling any agency or program referenced in § 435.945(b) to verify income, eligibility of, and the amount of assistance for its applicants and recipients.
(a) The agency must request and use information timely in accordance with §§ 435.948, 435.952, and 435.953 of this subpart for verifying Medicaid eligibility and the amount of medical assistance payments.
(b) The agency must furnish timely to other agencies in the State and in other States and to Federal programs income, eligibility and medical assistance payment information for verifying eligibility or benefit amounts for the programs listed in § 435.948(a)(6) of this subpart. In addition, the agency must furnish income and eligibility information to—
(1) The child support enforcement program under part D of title IV of the Act; and
(2) SSA for old age, survivors and disability benefits under title II and for SSI benefits under title XVI of the Act.
(c) The agency must, upon request, reimburse another agency listed in § 435.948(a)(6) of this subpart or paragraph (b) of this section for reasonable costs incurred in furnishing information, including new developmental costs associated with furnishing the information to another agency.
(d) The agency must inform all applicants in writing at the time of application that the agency will obtain and use information available to it under section 1137 of the Act to verify income, eligibility and the correct amount of medical assistance payments. The agency must give each recipient the same notice when it redetermines eligibility. The requirements in this paragraph do not apply in the case of applicants or recipients whose eligibility is determined by AFDC or by SSA under section 1634 of the Act.
(e) The agency must report as the Secretary prescribes for the purposes of determining compliance with §§ 431.305, 431.800, 435.910, 435.919 and 435.940 through 435.965 of this chapter and of evaluating the effectiveness of the income and eligibility verification system.
(f) The agency must execute written agreements with other agencies before releasing data to or requesting data from, those agencies. The agreements, at a minimum, must specify:
(1) The information to be exchanged;
(2) The titles of all agency officials with the authority to request income and eligibility information;
(3) The methods, including the formats to be used, and the timing for requesting and providing the information (see also paragraph (f)(6) of this section);
(4) The safeguards limiting the use and disclosure of the information as required by Federal or State law or regulations;
(5) The method, if any, the agency will use to reimburse reasonable costs of furnishing the information; and
(6) In the case of an agreement between a SWICA or a UC agency and the Medicaid agency, that the Medicaid agency will obtain information on applicants at least twice monthly; and
(7) In the case of an agreement between any Federal agency and the Medicaid agency for data on individuals, provisions relating to—
(i) Purpose and legal authority;
(ii) Justification and expected results;
(iii) Records description (including specific identification of the system of records, the number of records, what data elements will be included in the match, and projected starting and completion dates);
(iv) Notice procedures;
(v) Verification procedures;
(vi) Disposition of matched items;
(vii) Security procedures;
(viii) Records usage, duplication and redisclosure restrictions;
(ix) Records accuracy assessments; and
(x) Access by the Comptroller General.
(g) SWICA that does not use the quarterly wages reported by employers as required by Section 1137 of the Act of unemployment insurance benefit calculations must maintain wage information that:
(1) Contains the SSN, full name, wages earned for the period of the report, and an identifier of the employer;
(2) Includes all employers covered by the States' UC law;
(3) Accumulates earnings reported by employers for no longer periods than calendar quarters;
(4) Is reported to the SWICA within 30 days after the end of the quarter;
(5) Is machine readable; and
(6) Is accessible to agencies in other States that have executed agreements as required in § 435.945(f) of this chapter and to SSA for use in making eligibility or benefit determinations under Title II or XVI of the Act.
(a) Except as provided in paragraphs (d), (e), and (f) of this section, the agency must request information from the sources specified in this paragraph for verifying Medicaid eligibility and the correct amount of medical assistance payments for each applicant (unless obviously ineligible on the face of his or her application) and recipient. The agency must request—
(1) State wage information maintained by the SWICA during the application period and at least on a quarterly basis;
(2) Information about net earnings from self-employment, wage and payment of retirement income, maintained by SSA and available under Section 6103(l)(7)(A) of the Internal Revenue Code of 1954, for applicants during the application period and for recipients for whom the information has not previously been requested;
(3) Information about benefit and other eligibility related information available from SSA under titles II and XVI of the Social Security Act for applicants during the application period and for recipients for whom the information has not previously been requested;
(4) Unearned income information from the Internal Revenue Service available under Section 6103(l)(7)(B) of the Internal Revenue Code of 1954, during the application period and at least yearly;
(5) Unemployment compensation information maintained by the agency administering State unemployment compensation laws (under the provisions of section 3304 of the Internal Revenue Code and section 303 of the Act) as follows:
(i) For an applicant, during the application period and at least for each of the three subsequent months;
(ii) For a recipient that reports a loss of employment, at the time the recipient reports that loss and for at least each of the three subsequent months.
(iii) For an applicant or a recipient who is found to be receiving unemployment compensation benefits, at least for each month until the benefits are reported to be exhausted.
(6) Any additional income, resource, or eligibility information relevant to determinations concerning eligibility or correct amount of medical assistance payments available from agencies in the State or other States administering the following programs as provided in the agency's State plan:
(i) AFDC;
(ii) Medicaid;
(iii) State-administered supplementary payment programs under Section 1616(a) of the Act;
(iv) SWICA;
(v) Unemployment compensation;
(vi) Food stamps; and
(vii) Any State program administered under a plan approved under Title I (assistance to the aged), X (aid to the blind), XIV (aid to the permanently and totally disabled), or XVI (aid to the aged, blind, and disabled in Puerto Rico, Guam, and the Virgin Islands) of the Act.
(b) The agency must request information on applicants from the sources listed in paragraph (a)(1) through (a)(5) of this section at the first opportunity provided by these sources following the receipt of the application. If an applicant cannot provide an SSN at application, the agency must request the information at the next available opportunity after receiving the SSN.
(c) The agency must request the information required in paragraph (a) of this section by SSN, using each SSN furnished by the individual or received through verification.
(d)
(e)
(2) The agency must continue to meet the requirements of this section unless the Secretary has approved the request.
(f)
(a) Except as provided under § 435.953, the agency must review and compare against the case file all information received under §§ 435.940 through 435.960 to determine whether it affects the applicant's or recipient's eligibility or amount of medical assistance payment. The agency also must independently verify the information if required by § 435.955 or if determined appropriate by agency experience.
(b) For applicants, if the information is received during the application period, it must be used, to the extent possible, making eligibility determinations. If it is received after the eligibility determination, it must be used as specified for recipients in paragraphs (c) and (d) of this section.
(c) Except as specified in § 435.953 of this subpart and paragraph (d) of this section, for recipients, the agency must, within 45 days of receipt of an item of information, request verification (if appropriate), determine whether the information affects eligibility or the amount of medical assistance payment, and either initiate a notice of case action to advise the recipient of any adverse action the agency intends to take or make an entry in the casefile that no further action is necessary.
(d) Subject to paragraph (e) of this section, if the agency does not receive requested third party verification within the 45-day period after receipt of information, the agency may determine whether the information affects eligibility or correct amount of medical assistance payment after the 45-day period. However, the agency must make any delayed determinations permitted under this paragraph—
(1) Promptly, as required by § 435.916, if the verification is received before the next redetermination; or
(2) In conjunction with the next redetermination if no verification is received before that redetermination.
(e) The number of determinations delayed beyond 45 days from receipt of an item of information (as permitted by paragraph (d) of this section) must not exceed twenty percent of the number of items of information for which verification was requested.
(f) The agency must use appropriate procedures to monitor the timeliness requirements of this section.
(g) The requirements of this section do not relieve the agency of its responsibility for determinations of erroneous payments or the agency's liability for those erroneous payments, as defined in subpart P of part 431 of this chapter.
(a) With respect to information received on recipients under §§ 435.940 through 435.960, the agency may either review and compare against the case file all items of information received or it may identify (target) separately for each data source the information items that are most likely to be most productive in identifying and preventing ineligibility and incorrect payments.
(b) An agency that wishes to exclude categories of information items must submit for the Secretary's approval a follow-up plan describing the categories that it proposes to exclude. For each category, the agency must provide a reasonable justification that follow-up is not cost-effective; a formal cost/benefit analysis is not required.
(c) If an agency receives an item of unemployment compensation information from the Internal Revenue Service or earnings information from SSA that duplicates an item of information previously received from another source and followed up, the agency may exclude that information item without justification.
(d) An agency may submit a follow-up plan or alter its plan at any time by notifying the Secretary and submitting the necessary justification. The Secretary approves or disapproves categories of items to be excluded under the plan within 60 days of its submission. The categories approved by the Secretary constitute an approved agency follow-up plan for IEVS.
(a) Unless waived under paragraph (d) of this section, based on information received from a computerized data match in which information on an individual is provided to the agency by a Federal agency, the agency may not terminate, deny, suspend, or reduce medical assistance to that individual until it has taken appropriate steps to verify the information independently. The agency must independently verify information relating to—
(1) The amount of the income and resource that generated the income involved;
(2) Whether the applicant or recipient actually has (or had) access to the resource or income (or both) for his or her own use;
(3) The period or periods when the individual actually has (or had) access to the resource or income or both.
(b) The agency must verify the information by either
(1) Requesting the entity from which the information originally came to verify the fact and amount of income or resource; or
(2) Sending the applicant or recipient a letter informing that individual of the information received and asking him or her to respond within a specified period. The letter must clearly explain the information the agency has
(c)(1) If the original source of the income or resource or the applicant or recipient verifies the information, and the agency intends to reduce, suspend, terminate or deny medical assistance based on the information, the agency must send the applicant or recipient a notice of the action to be taken and include information on the right to appeal and opportunity for a hearing under §§ 431.200 through 431.246 of this chapter (see also § 435.912 and § 435.919).
(2) If the applicant or recipient fails to respond after reasonable attempts to contact him or her, the agency must proceed to deny, terminate, reduce or suspend medical assistance based on the applicant's or recipient's failure to cooperate.
(3) If the applicant or recipient disputes the information, the agency must obtain evidence (from the source of the data, applicant, recipient, or otherwise) to substantiate any negative case action it may take.
(d) The independent verification requirement concerning a category of data received from a Federal benefit agency may be waived if the Federal agency's Data Integrity Board approves the waiver. The Federal benefit agency involved in the data exchange will develop the request by petitioning its Data Integrity Board for a waiver of independent verification by a Medicaid State agency. The State agency must furnish the Federal agency with any information it needs to seek the Data Integrity Board's approval of the waiver.
(e) In accordance with the Federal agency's procedures, the agency must provide data on the costs and benefits of the matching program to the Federal agency from which it receives information on individuals.
(f) In accordance with the Federal agency's procedures, the agency must certify to the Federal agency that it will not take adverse action against an individual until the information has been independently verified and until 10 days (or sooner if permitted by § 431.213 or § 431.214) after the individual has been notified of the findings and given an opportunity to contest.
(g) In accordance with the Federal agency's procedures for renewals of matching programs, the agency must certify to the Federal agency that the terms of the agreement have been followed.
(a) The agency must maintain for all applicants and recipients within an agency file the SSN, surname and other data elements in a format that at a minimum allows the agency to furnish and to obtain eligibility and income information from the agencies or programs referenced in § 435.945(b) and § 435.948(a).
(b) The format to be used will be prescribed by—
(1) CMS when the agency furnishes information to, or requests information from, any Federal or State agency, except SSA and the Internal Revenue Service as specified in paragraphs (b) (2) and (3), respectively;
(2) The Commissioner of Social Security when the agency requests information from SSA; and
(3) The Commissioner of Internal Revenue when the agency requests information from the Internal Revenue Service.
(a) If the agency submits, by May 29, 1986, a plan describing a good faith effort to come into compliance with the requirements of section 1137 of the Act and of §§ 435.910 and 435.940 through 435.960 of this subpart, the Secretary may, after consultation with the Secretary of Agriculture and the Secretary of Labor, grant a delay in the effective date of §§ 435.910 and 435.940 through 435.960, but not beyond September 30, 1986.
(b) The Secretary may not grant a delay of the effective date of section 1137(c) of the Act, which is implemented by § 435.955 (a) and (c). (The provisions of these statutory and regulation sections require the agency to follow certain procedures before taking
This subpart specifies when, and the extent to which, FFP is available in expenditures for determining eligibility and for Medicaid services to individuals determined eligible under this part, and prescribes limitations and conditions on FFP for those expenditures.
(a) FFP is available in the necessary administrative costs the State incurs in—
(1) Determining and redetermining Medicaid eligibility and in providing Medicaid to eligible individuals; and
(2) Determining presumptive eligibility for children and providing services to presumptively eligible children.
(b) Administrative costs include any costs incident to an eye examination or medical examination to determine whether an individual is blind or disabled.
(a) Except for the limitations and conditions specified in §§ 435.1007, 35.1008, 435.1009, and 438.814 of this chapter, FFP is available in expenditures for Medicaid services for all recipients whose coverage is required or allowed under this part.
(b) FFP is available in expenditures for services provided to recipients who were eligible for Medicaid in the month in which the medical care or services were provided except that, for recipients who establish eligibility for Medicaid by deducting incurred medical expenses from income, FFP is not available for expenses that are the recipient's liability. (See §§ 435.914 and 436.901 of this subchapter for regulations on retroactive eligibility for Medicaid.)
(c) FFP is available in expenditures for services covered under the plan that are furnished—
(1) To children who are determined by a qualified entity to be presumptively eligible;
(2) During a period of presumptive eligibility;
(3) By a provider that is eligible for payment under the plan; and
(4) Regardless of whether the children are determined eligible for Medicaid following the period of presumptive eligibility.
(a) If the Social Security Administration (SSA) notifies an agency that a recipient has been determined ineligible for SSI, FFP is available in Medicaid expenditures for services to the recipient as follows:
(1) If the agency receives the SSA notice by the 10th day of the month, FFP is available under this section only through the end of the month unless the recipient requests a hearing under subpart E, part 431 of this subchapter.
(2) If the agency receives the SSA notice after the 10th day of the month, FFP is available only through the end of the following month, unless the recipient requests a hearing under subpart E, part 431 of this subchapter.
(3) If a recipient requests a hearing, FFP is available as specified in subpart E, part 431 of this subchapter.
(b) The agency must take prompt action to determine eligibility after receiving the SSA notice.
(c) When a change in Federal law affects the eligibility of substantial numbers of Medicaid recipients, the Secretary may waive the otherwise applicable FFP requirements and redetermination time limits of this section, in order to provide a reasonable time to complete such redeterminations. The Secretary will designate an additional amount of time beyond that allowed
(a) FFP is available, as specified in paragraph (b) of this section, in expenditures for services provided to recipients who are overcoming certain eligibility conditions, including blindness, disability, continued absence or incapacity of a parent, or unemployment of a parent.
(b) FFP is available for a period not to exceed—
(1) The period during which a recipient of AFDC, SSI or an optional State supplement continues to receive cash payments while these conditions are being overcome; or
(2) For recipients eligible for Medicaid only and recipients of AFDC, SSI or an optional State supplement who do not continue to receive cash payments, the second month following the month in which the recipient's Medicaid eligibility would have been terminated.
For recipients in institutions whose Medicaid eligibility is based on a special income standard established under § 435.236, FFP is available in expenditures for services provided to those individuals only if their income before deductions, as determined by SSI budget methodology, does not exceed 300 percent of the SSI benefit amount payable under section 1611(b)(1) of the Act to an individual in his own home who has no income or resources.
FFP is available in expenditures for services provided to individuals receiving optional State supplements but not receiving SSI, if their income before deductions, as determined by SSI budget methodology, does not exceed 300 percent of the SSI benefit amount payable under section 1611(b)(1) of the Act to an individual who has no income and resources.
(a) FFP is available in expenditures for covered services provided to categorically needy recipients, medically needy recipients, and qualified Medicare beneficiaries, subject to the restrictions contained in subpart K of this part and as provided in paragraphs (b) and (e) of this section. However, the restrictions listed in paragraphs (b) and (e) of this section do not apply to expenditures for medical assistance made on behalf of qualified Medicare beneficiaries under section 1905(p) of the Act; individuals receiving Medicaid as categorically needy under section 1902(a)(10)(A)(i) (I), (II), (III), (IV), (V), (VI), or (VII) and section 1902(a)(10)(A)(ii) (I), (IX), or (X) and section 1905(u) of the Act; individuals who are eligible to receive benefits (or would be eligible for those benefits if they were not in a medical institution); and any individuals deemed to be members of the groups identified in this sentence.
(b) Except as provided in paragraphs (c) and (d) of this section, FFP is not available in State expenditures for individuals (including the medically needy) whose annual income after deductions specified in § 435.831(a) and (c) exceeds the following amounts, rounded to the next higher multiple of $100.
(c) In the case of a family consisting only of two individuals, both of whom are adults and at least one of whom is aged, blind, or disabled, the State of California may use the amount of the AFDC payment most frequently made to a family of one adult and two children for purposes of computing the
(d) For purposes of paragraph (b)(1) of this section, a State that as of June 1, 1989, has in its State plan (as defined in section 2373(c)(5) of Public Law 98-369 as amended by section 9 of Public Law 100-93) an amount for individuals that was reasonably related to 133
(e) FFP is not available in expenditures for services provided to categorically needy and medically needy recipients subject to the FFP limits if their annual income, after the cash assistance income deductions and any income disregards in the State plan authorized under section 1902(r)(2) of the Act are applied, exceeds the 133
(f) A State may use the less restrictive income methodologies included under its State plan as authorized under § 435.601 in determining whether a family's income exceeds the limitation described in paragraph (b) of this section.
Except for individuals described in § 435.406(a)(1)(v), FFP will not be available to a State with respect to expenditures for medical assistance furnished to individuals unless the State has obtained satisfactory documentary evidence of citizenship or national status, as described in § 435.407 that complies with the requirements of section 1903(x) of the Act.
(a) FFP is not available in expenditures for services provided to—
(1) Individuals who are inmates of public institutions as defined in § 435.1010; or
(2) Individuals under age 65 who are patients in an institution for mental diseases unless they are under age 22 and are receiving inpatient psychiatric services under § 440.160 of this subchapter.
(b) The exclusion of FFP described in paragraph (a) of this section does not apply during that part of the month in which the individual is not an inmate of a public institution or a patient in an institution for tuberculosis or mental diseases.
(c) An individual on conditional release or convalescent leave from an institution for mental diseases is not considered to be a patient in that institution. However, such an individual who is under age 22 and has been receiving inpatient psychiatric services under § 440.160 of this subchapter is considered to be a patient in the institution until he is unconditionally released or, if earlier, the date he reaches age 22.
For purposes of FFP, the following definitions apply:
(a) He is in a public educational or vocational training institution for purposes of securing education or vocational training; or
(b) He is in a public institution for a temporary period pending other arrangements appropriate to his needs.
(1) Receives room, board and professional services in the institution for a 24 hour period or longer, or
(2) Is expected by the institution to receive room, board and professional services in the institution for a 24 hour period or longer even though it later develops that the patient dies, is discharged or is transferred to another facility and does not actually stay in the institution for 24 hours.
(a) Is primarily for the diagnosis, treatment, or rehabilitation of the mentally retarded or persons with related conditions; and
(b) Provides, in a protected residential setting, ongoing evaluation, planning, 24-hour supervision, coordination, and integration of health or rehabilitative services to help each individual function at his greatest ability.
(a) Is organized to provide medical care, including nursing and convalescent care;
(b) Has the necessary professional personnel, equipment, and facilities to manage the medical, nursing, and other health needs of patients on a continuing basis in accordance with accepted standards;
(c) Is authorized under State law to provide medical care; and
(d) Is staffed by professional personnel who are responsible to the institution for professional medical and nursing services. The services must include adequate and continual medical care and supervision by a physician; registered nurse or licensed practical nurse supervision and services and nurses' aid services, sufficient to meet nursing care needs; and a physician's guidance on the professional aspects of operating the institution.
(a) It is attributable to—
(1) Cerebral palsy or epilepsy; or
(2) Any other condition, other than mental illness, found to be closely related to mental retardation because this condition results in impairment of general intellectual functioning or adaptive behavior similar to that of mentally retarded persons, and requires treatment or services similar to those required for these persons.
(b) It is manifested before the person reaches age 22.
(c) It is likely to continue indefinitely.
(d) It results in substantial functional limitations in three or more of the following areas of major life activity:
(1) Self-care.
(2) Understanding and use of language.
(3) Learning.
(4) Mobility.
(5) Self-direction.
(6) Capacity for independent living.
(a) A medical institution as defined in this section;
(b) An intermediate care facility as defined in §§ 440.140 and 440.150 of this chapter;
(c) A publicly operated community residence that serves no more than 16 residents, as defined in this section; or
(d) A child-care institution as defined in this section with respect to—
(1) Children for whom foster care maintenance payments are made under title IV-E of the Act; and
(2) Children receiving AFDC—foster care under title IV-A of the Act.
(a) In general, a publicly operated community residence means—
(1) It is publicly operated as defined in 20 CFR 416.231(b)(2).
(2) It is designed or has been changed to serve no more than 16 residents and it is serving no more than 16; and
(3) It provides some services beyond food and shelter such as social services, help with personal living activities, or training in socialization and life skills. Occasional medical or remedial care may also be provided as defined in 45 CFR 228.1; and
(b) A publicly operated community residence does not include the following facilities, even though they accommodate 16 or fewer residents:
(1) Residential facilities located on the grounds of, or immediately adjacent to, any large institution or multiple purpose complex.
(2) Educational or vocational training institutions that primarily provide an approved, accredited, or recognized program to individuals residing there.
(3) Correctional or holding facilities for individuals who are prisoners, have been arrested or detained pending disposition of charges, or are held under court order as material witnesses or juveniles.
(4) Hospitals, nursing facilities, and intermediate care facilities for the mentally retarded.
(a) Except as specified in paragraph (b) of this section, FFP is not available in Medicaid expenditures in any quarter in which the State does not have in
(b) This section does not apply to any State that meets the conditions of section 212(f) of Pub. L. 93-66.
(a) This section applies to States that make optional State supplement payments under section 1616(a) of the Act and mandatory supplement payments under section 212(a) of Pub. L. 93-66.
(b) FFP in Medicaid expenditures is not available during any period in which the State does not have in effect an agreement with the Secretary under section 1618 of the Act to maintain its supplementary payments.
(a)
(b) Scope. This subpart prescribes the requirements for providing medical assistance to special groups who are not eligible for Medicaid as categorically or medically needy.
(1) In the case of a child on whose behalf a Medicaid application has been filed, the day on which a decision is made on that application; or
(2) In the case of a child on whose behalf a Medicaid application has not been filed, the last day of the month following the month in which the determination of presumptive eligibility was made.
(1) Furnishes health care items and services covered under the approved plan and is eligible to receive payments under the approved plan;
(2) Is authorized to determine eligibility of a child to participate in a Head Start program under the Head Start Act;
(3) Is authorized to determine eligibility of a child to receive child care services for which financial assistance is provided under the Child Care and Development Block Grant Act of 1990;
(4) Is authorized to determine eligibility of an infant or child to receive assistance under the special nutrition program for women, infants, and children (WIC) under section 17 of the Child Nutrition Act of 1966;
(5) Is authorized to determine eligibility of a child for medical assistance under the Medicaid State plan, or eligibility of a child for child health assistance under the State Children's Health Insurance Program;
(6) Is an elementary or secondary school, as defined in section 14101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 8801);
(7) Is an elementary or secondary school operated or supported by the Bureau of Indian Affairs;
(8) Is a State or Tribal child support enforcement agency;
(9) Is an organization that—
(i) Provides emergency food and shelter under a grant under the Stewart B. McKinney Homeless Assistance Act;
(ii) Is a State or Tribal office or entity involved in enrollment in the program under title XIX, Part A of title IV, or title XXI; or
(iii) Determines eligibility for any assistance or benefits provided under any program of public or assisted housing that receives Federal funds, including the program under section 8 or any other section of the United States Housing Act of 1937 (42 U.S.C. 1437) or under the Native American Housing Assistance and Self Determination Act of 1996 (25 U.S.C. 4101
(10) Any other entity the State so deems, as approved by the Secretary.
(a) The agency may provide services to children under age 19 during one or more periods of presumptive eligibility following a determination by a qualified entity that the child's estimated gross family income or, at the State's option, the child's estimated family income after applying simple disregards, does not exceed the applicable income standard.
(b) If the agency elects to provide services to children during a period of presumptive eligibility, the agency must—
(1) Provide qualified entities with application forms for Medicaid and information on how to assist parents, caretakers and other persons in completing and filing such forms;
(2) Establish procedures to ensure that qualified entities—
(i) Notify the parent or caretaker of the child at the time a determination regarding presumptive eligibility is made, in writing and orally if appropriate, of such determination;
(ii) Provide the parent or caretaker of the child with a regular Medicaid application form;
(iii) Within five working days after the date that the determination is made, notify the agency that a child is presumptively eligible;
(iv) For children determined to be presumptively eligible, notify the child's parent or caretaker at the time the determination is made, in writing and orally if appropriate, that—
(A) If a Medicaid application on behalf of the child is not filed by the last day of the following month, the child's presumptive eligibility will end on that last day; and
(B) If a Medicaid application on behalf of the child is filed by the last day of the following month, the child's presumptive eligibility will end on the day that a decision is made on the Medicaid application; and
(v) For children determined not to be presumptively eligible, notify the child's parent or caretaker at the time the determination is made, in writing and orally if appropriate—
(A) Of the reason for the determination; and
(B) That he or she may file an application for Medicaid on the child's behalf with the Medicaid agency;
(3) Provide all services covered under the plan, including EPSDT; and
(4) Allow determinations of presumptive eligibility to be made by qualified entities on a Statewide basis.
(c) The agency must adopt reasonable standards regarding the number of periods of presumptive eligibility that will be authorized for a child in a given time frame.
Sec. 1102 of the Social Security Act (42 U.S.C. 1302).
This part sets forth, for Guam, Puerto Rico, and the Virgin Islands—
(a) The eligibility provisions that a State plan must contain;
(b) The mandatory and optional groups of individuals to whom Medicaid is provided under a State plan;
(c) The eligibility requirements and procedures that a Medicaid agency must use in determining and redetermining eligibility, and requirements it may not use; and
(d) The availability of FFP for providing Medicaid and for administering the eligibility provisions of the plan.
This part implements the following sections of the Act and public laws that state requirements and standards for eligibility:
Age requirements of more than 65 years;
State residence requirements excluding individuals who reside in the State; and
Citizenship requirement excluding United States citizens.
As used in this part—
(1)
(i) Has a family income at or below 200 percent of the Federal poverty line for a family of the size involved;
(ii) Resides in a State with no Medicaid applicable income level (as defined in § 457.10 of this chapter); or,
(iii) Resides in a State that has a Medicaid applicable income level (as defined in § 457.10) and has family income that either:
(A) Exceeds the Medicaid applicable income level for the age of such child, but not by more than 50 percentage points (expressed as a percentage of the Federal poverty line); or
(B) Does not exceed the income level specified for such child to be eligible for medical assistance under the policies of the State plan under title XIX on June 1, 1997.
(2)
(i) A child shall not be considered to be covered by health insurance coverage based on coverage offered by the State under a program in operation prior to July 1, 1997 if that program received no Federal financial participation;
(ii) A child shall not be considered to be covered under a group health plan or health insurance coverage if the child did not have reasonable geographic access to care under that coverage.
(3) For purposes of this section, policies of the State plan under title XIX plan include policies under a Statewide demonstration project under section 1115(a) of the Act other than a demonstration project that covered an expanded group of eligible children but that either—
(i) Did not provide inpatient hospital coverage; or
(ii) Limited eligibility to children previously enrolled in Medicaid, imposed premiums as a condition of initial or continued enrollment, and did not impose a general time limit on eligibility.
A State plan must—
(a) Provide that the requirements of this part are met; and
(b) Specify the groups to whom Medicaid is provided, as specified in subparts B, C, and D of this part, and the conditions of eligibility for individuals in those groups.
This subpart prescribes requirements for coverage of categorically needy individuals.
(a) A Medicaid agency must provide Medicaid to individuals receiving cash assistance under OAA, AFDC, AB, APTD, or AABD.
(b) For purposes of this section, an individual is receiving cash assistance if his needs are considered in determining the amount of the payment. This includes an individual whose presence in the home is considered essential to the well-being of a recipient under the State's plan for OAA, AFDC, AB, APTD, or AABD if that plan were as broad as allowed under the Act for FFP.
(a) The agency must provide Medicaid to individuals who would be eligible for OAA, AB, APTD, or AABD except for an eligibility requirement used in those programs that is specifically prohibited under title XIX of the Act.
(b) The agency also must provide Medicaid to:
(1) Individuals denied AFDC solely because of policies requiring the deeming of income and resources of the following individuals who are not included as financially responsible relatives under section 1902(a)(17)(D) of the Act:
(i) Stepparents who are not legally liable for support of stepchildren under a State law of general applicability;
(ii) Grandparents
(iii) Legal guardians;
(iv) Aliens sponsors who are not organizations; and
(v) Siblings.
(2) [Reserved]
The agency must provide Medicaid to individuals who meet the following conditions:
(a) In August 1972, the individual was entitled to OASDI and—
(1) He was receiving cash assistance; or
(2) He would have been eligible for cash assistance if he had applied, and the Medicaid plan covered this optional group; or
(3) He would have been eligible for cash assistance if he were not in a medical institution or intermediate care facility, and the Medicaid plan covered this optional group.
(b) The individual would currently be eligible for cash assistance except that the increase in OASDI under Pub. L. 92-336 raised his income over the limit allowed under the cash assistance program. This includes an individual who—
(1) Meets all current requirements for cash assistance except for the requirement to file an application; or
(2) Would meet all current requirements for cash assistance if he were not in a medical institution or intermediate care facility, and the Medicaid plan covers this optional group.
(a) The Medicaid agency must provide Medicaid to individuals deemed to be receiving AFDC, as specified in this section.
(b) The State must deem individuals to be receiving AFDC who are denied a cash payment from the title IV-A State agency solely because the amount of the AFDC payment would be less than $10.
(c) The State may deem participants in a work supplementation program to be receiving AFDC under section 414(g) of the Act. This section permits States, for purposes of title XIX, to deem an individual and any child or relative of the individual (or other individual living in the same household) to be receiving AFDC, if the individual—
(1) Participates in a State-operated work supplementation program under section 414 of the Act; and
(2) Would be eligible for an AFDC cash payment if the individual were not participating in the work supplementation program.
(d) The State must deem to be receiving AFDC those individuals who are denied AFDC payments from the title IV-A State agency solely because that agency is recovering an overpayment.
(e) The State must deem to be receiving AFDC individuals described in section 473(a)(1) of the Act—
(1) For whom an adoption assistance agreement is in effect under title IV-E
(2) For whom foster care maintenance payments are made under title IV-E of the Act.
(f) The State must deem an individual to be receiving AFDC if a new collection or increased collection of child or spousal support under title IV-D of the Social Security Act results in the termination of AFDC eligibility in accordance with section 406(h) of the Social Security Act. States must continue to provide Medicaid for four consecutive calendar months, beginning with the first month of AFDC ineligibility, to each dependent child and each relative with whom such a child is living (including the eligible spouse of such relative as described in section 406(b) of the Social Security Act) who:
(1) Becomes ineligible for AFDC on or after August 16, 1984; and
(2) Has received AFDC for at least three of the six months immediately preceding the month in which the individual becomes ineligible for AFDC; and
(3) Becomes ineligible for AFDC wholly or partly as a result of the initiation of or an increase in the amount of a child or spousal support collection under title IV-D.
(g)(1) Except as provided in paragraph (g)(2) of this section, individuals who are eligible for extended Medicaid lose this coverage if they move to another State during the 4-month period. However, if they move back to and reestablish residence in the State in which they have extended coverage, they are eligible for any of the months remaining in the 4-month period in which they are residents of the State.
(2) If a State has chosen in its State plan to provide Medicaid to non-residents, the State may continue to provide the 4-month extended benefits to individuals who have moved to another State.
(h) For purposes of paragraph (f) of this section:
(1) The new collection or increased collection of child or spousal support results in the termination of AFDC eligibility when it actively causes or contributes to the termination. This occurs when:
(i) The change in support collection in and of itself is sufficient to cause ineligibility. This rule applies even if the support collection must be added to other, stable income. It also applies even if other independent factors, alone or in combination with each other, might simultaneously cause ineligibility; or
(ii) The change in support contributes to ineligibility but does not by itself cause ineligibility. Ineligibility must result when the change in support is combined with other changes in income or changes in other circumstances and the other changes in income or circumstances cannot alone or in combination result in termination without the change in support.
(2) In cases of increases in the amounts of both the support collections and earned income, eligibility under this section does not preclude eligibility under 45 CFR 233.20(a)(14) or section 1925 of the Social Security Act (which was added by section 303(a) of the Family Support Act of 1988 (42 U.S.C. 1396r-6)). Extended periods resulting from both an increase in the amount of the support collection and from an increase in earned income must run concurrently.
(a) If a family loses AFDC solely because of increased income from employment or increased hours of employment, the agency must continue to provide Medicaid for 4 months to all members of the family if—
(1) The family received AFDC in any 3 or more months during the 6-month period immediately before the month in which it became ineligible for AFDC; and
(2) At least one member of the family is employed throughout the 4-month period, although this need not be the same member for the whole period.
(b) The 4 calendar month period begins on the date AFDC is terminated. If
The agency must provide Medicaid to children for whom adoption assistance or foster care maintenance payments are made under title IV-E of the Act.
(a) The Medicaid agency must provide Medicaid to a pregnant woman whose pregnancy has been medically verified and who—
(1) Would be eligible for an AFDC cash payment (or would be eligible for an AFDC cash payment if coverage under the State's AFDC plan included the AFDC-unemployed parents program) if her child had been born and was living with her in the month of payment;
(2) Is a member of a family that would be eligible for an AFDC cash payment if the State's AFDC plan included an AFDC-unemployed parents program; or
(3) Meets the income and resource requirements of the State's approved AFDC plan. In determining whether the woman meets the AFDC income and resource requirements, the unborn child or children are considered members of the household, and the woman's family is treated as though deprivation exists.
(b) The provisions of paragraphs (a) (1) and (2) of this section are effective October 1, 1984. The provisions of paragraph (a)(3) of this section are effective July 1, 1986.
(c) The agency must provide Medicaid to children who meet all of the following criteria:
(1) They are born after September 30, 1983;
(2) Effective October 1, 1988, they are under age 6 (or if designated by the State, any age that exceeds age 6 but does not exceed age 8), and effective October 1, 1989 they are under age 7 (or if designated by the State, any age that exceeds age 7 but does not exceed age 8); and
(3) They meet the income and resource requirements of the State's approved AFDC plan.
(a)
(b)
(c)
(a) The Medicaid agency must provide categorically needy Medicaid eligibility for an extended period following termination of pregnancy to women who, while pregnant, applied for, were eligible for, and received Medicaid services on the day that their pregnancy ends. This period extends from the last day of pregnancy through the end of the month in which a 60-day period, beginning on the last day of the pregnancy, ends. Eligibility must be provided, regardless of changes in the woman's financial circumstances that may occur within this extended period. These pregnant women are eligible for the extended period for all services under the plan that are pregnancy-related (as defined in § 440.210(c)(1) of this subchapter).
(b) The provisions of paragraph (a) of this section apply to Medicaid furnished on or after April 7, 1986.
(a) The agency must provide Medicaid eligibility to a child born to a woman who has applied for, has been determined eligible and is receiving Medicaid on the date of the child's birth. The child is deemed to have applied and been found eligible for Medicaid on the date of birth and remains eligible for one year so long as the woman remains (or would remain if pregnant) eligible and the child is a member of the woman's household. This provision applies in instances where the labor and delivery services were furnished prior to the date of application and covered by Medicaid based on retroactive eligibility.
(b) The agency must provide Medicaid eligibility in the same manner described in paragraph (a) of this section to a child born to an otherwise-eligible qualified alien woman subject to the 5-year bar so long as the woman has filed a complete Medicaid application, including but not limited to meeting residency, income and resource requirements, has been determined eligible, is receiving Medicaid on the date of the child's birth, and remains (or would remain if pregnant) Medicaid eligible. All standard Medicaid application procedures apply, including timely determination of eligibility and adequate notice of the agency's decision concerning eligibility. A 5-year bar qualified alien receiving emergency medical services only under § 435.139 of this chapter is considered to be Medicaid-eligible and receiving Medicaid for purposes of this provision. With respect to whether the mother remains (or would remain if pregnant) eligible for Medicaid after the birth of the child, the State must determine whether a 5-year bar qualified alien would remain eligible for emergency services under § 435.139 of this chapter. In determining whether the woman would remain eligible for these services, the State must consider whether the woman would remain eligible if pregnant. This provision applies in instances where the labor and delivery services were furnished prior to the date of application and covered by Medicaid based on retroactive eligibility.
(c) The agency must provide Medicaid eligibility in the same manner described in paragraph (a) of this section to a child born to an otherwise-eligible non-qualified alien woman so long as the woman has filed a complete Medicaid application (other than providing a social security number or demonstrating immigration status), including but not limited to meeting residency, income and resource requirements, has been determined eligible, is receiving Medicaid on the date of the child's birth, and remains (or would remain if pregnant) Medicaid eligible. All standard Medicaid application procedures apply, including timely determination of eligibility and adequate notice of the agency's decision concerning eligibility. A non-qualified alien receiving emergency medical services only under § 435.139 of this chapter is considered to be Medicaid-eligible and receiving Medicaid for purposes of this provision. With respect to whether the mother remains (or would remain if pregnant) eligible for Medicaid after the birth of the child, the State must determine whether a non-qualified alien would remain eligible for emergency services under § 435.139 of this chapter. In determining whether the woman would remain eligible for these services, the State must consider whether the woman would remain eligible if pregnant. This provision applies in instances where the labor and delivery services were furnished prior to the date of application and covered by Medicaid based on retroactive eligibility.
(d) A redetermination of eligibility must be completed on behalf of the children described in this provision in accordance with the procedures at § 435.916. At that time, the State must collect documentary evidence of citizenship and identity as required under § 436.406.
The agency must provide the services necessary for the treatment of an emergency medical condition as defined in § 440.255(c) of this chapter to those aliens described in § 436.406(c) of this subpart.
This subpart specifies options for coverage of individuals as categorically needy.
(a) The agency may choose to cover as optional categorically needy any group or groups of the following individuals who are not receiving cash assistance and who meet the appropriate eligibility criteria for groups specified in the separate sections of this subpart:
(1) Aged individuals (65 years of age or older);
(2) Blind individuals (as defined in § 436.530);
(3) Disabled individuals (as defined in § 436.541);
(4) Individuals under age 21 (or, at State option), under age 20, 19, or 18) or reasonable classifications of these individuals;
(5) Specified relatives under section 406(b)(1) of the Act who have in their care an individual who is determined to be dependent) as specified in § 436.510;
(6) Pregnant women; and
(7) Essential spouses specified under § 436.230.
(b) If the agency provides Medicaid to any individual in an optional group specified in paragraph (a) of this section, the agency must provide Medicaid to all individuals who apply and are found eligible to be members of that group.
The agency may provide Medicaid to any group or groups of individuals specified under § 436.201(a)(1), (a)(2), (a)(3), (a)(5), and (a)(6) who are not mandatory categorically needy and who meet the income and resource requirements of the appropriate cash assistance program for their status (that is, OAA, AFDC, AB, APTD, or AABD).
The agency may provide Medicaid to any group or groups of individuals specified in § 436.201(a) who are in title XIX reimbursable medical institutions and who:
(a) Are ineligible for the cash assistance program appropriate for their status (that is, OAA, AFDC, AB, APTD, or AABD) because of lower income standards used under the program to determine eligibility for institutionalized individuals; but
(b) Would be eligible for aid or assistance under the State's approved plan under OAA, AFDC, AB, APTD, or AABD if they were not institutionalized.
(a) The agency may provide Medicaid to any group or groups of individuals specified under § 436.201(a) who:
(1) Would be eligible for OAA, AFDC, AB, APTD, or AABD if the State's plan under those programs included individuals whose coverage under title I, IV-A, X, XIV, or XVI of the Act is optional (for example, the agency may provide Medicaid to individuals who are 18
(2) Would qualify for OAA, AFDC, AB, APTD, or AABD if the State's plan under those programs did not contain eligibility requirements more restrictive than, or in addition to, those required under the appropriate title of the Act. (For example, the agency may provide Medicaid to individuals who would meet the Federal definition of disability, 45 CFR 233.80, but who do not meet the State's more restrictive definitions.)
(b) The agency may cover one or more optional groups under any of the titles of the Act without covering all such groups.
The agency may provide Medicaid to any group or groups of individuals in the community who meet the following requirements:
(a) The group would be eligible for Medicaid if institutionalized.
(b) In the absence of home and community-based services under a waiver granted under part 441—
(1) Subpart G of this subchapter, the group would otherwise require the level of care furnished in a hospital, NF, or an ICF/MR; or
(2) Subpart H of this subchapter, the group would otherwise require the level of care furnished in a NF and are age 65 or older.
(c) The group receives the waivered services.
(a) The agency may provide Medicaid to any group or groups of individuals specified under § 436.201(a)(4), (a)(5), and (a)(6) who would meet the income and resource requirements under the State's AFDC plan if their work-related child care costs were paid from their earnings rather than by a State agency as a service expenditure.
(b) The agency may use this option only if the State's AFDC plan deducts work-related child care costs from income to determine the amount of AFDC.
(a) The agency may provide Medicaid to individuals under age 21 (or at State option, under age 20, 19, or 18) or reasonable categories of these individuals as specified in paragraph (b) of this section, who are not receiving cash assistance but who meet the income and resource requirements of the State's approved AFDC plan.
(b) The agency may cover all individuals described in paragraph (a) of this section or reasonable classifications of those individuals. Examples of reasonable classifications are as follows:
(1) Individuals in foster homes or private institutions for whom a public agency is assuming a full or partial financial responsibility. If the agency covers these individuals, it may also provide Medicaid to individuals of the same age in foster homes or private institutions by private nonprofit agencies.
(2) Individuals in adoptions subsidized in full or in part by a public agency.
(3) Individuals in nursing facilities when nursing facility services are provided under the plan to individuals within the age group selected under this provision. If the agency covers these individuals, it may also provide Medicaid to individuals in intermediate care facilities for the mentally retarded.
(4) Individuals receiving active treatment as inpatients in psychiatric facilities or programs, if inpatient psychiatric services for individuals under 21 are provided under the plan.
(a) The agency may provide Medicaid to individuals under the age of 21 (or, at State option, age 20, 19, or 18)—
(1) For whom an adoption agreement (other than an agreement under title IV-E) between the State and adoptive parent(s) is in effect;
(2) Who, the State agency responsible for adoption assistance has determined, cannot be placed with adoptive parents without Medicaid because the child has special needs for medical or rehabilitative care; and
(3) Who meet either of the following:
(i) Were eligible for Medicaid under the State plan before the adoption agreement was entered into; or
(ii) Would have been eligible for Medicaid before the adoption agreement was entered into, if the eligibility standards and methodologies of the foster care program were used without employing the threshold title IV-A eligibility determination.
(b) For adoption assistance agreements entered into before April 7, 1986—
(1) The agency must deem the requirements of paragraph (a)(1) and (2) of this section to be met if the State adoption assistance agency determines that—
(i) At the time of the adoption placement, the child had special needs for medical or rehabilitative care that made the child difficult to place; and
(ii) There is in effect an adoption assistance agreement between the State and the adoptive parent(s).
(2) The agency must deem the requirements of paragraph (a)(3) of this section to be met if the child was found by the State to be eligible for Medicaid before the adoption assistance agreement was entered into.
The agency may provide Medicaid to—
(a) All individuals under age 19 who are optional targeted low-income children as defined in § 436.3; or
(b) Reasonable categories of these individuals.
The agency may provide Medicaid to the spouse of an individual receiving OAA, AB, APTD, or AABD, if—
(a) The spouse is living with the individual receiving cash assistance;
(b) The cash assistance agency has determined that the spouse is essential to the well-being of the individual and has considered the spouse's needs in determining the amount of cash assistance provided to the individual.
This subpart specifies the option for coverage of medically needy individuals.
(a) A Medicaid agency may provide Medicaid to individuals specified in this subpart who:
(1) Either:
(i) Have income that meets the standard in § 436.811; or
(ii) If their income is more than allowed under the standard, have incurred medical expenses at least equal to the difference between their income and the applicable income standards; and
(2) Have resources that meet the standard in §§ 436.840 and 436.843.
(b) If the agency chooses this option, the following provisions apply:
(1) The agency must provide Medicaid to the following individuals who meet the requirements of paragraph (a) of this section:
(i) All pregnant women during the course of their pregnancy who, except for income and resources, would be eligible for Medicaid as mandatory or optional categorically needy under subparts B and C of this part;
(ii) All individuals under 18 years of age who, except for income and resources, would be eligible for Medicaid as mandatory categorically needy under subpart B of this part;
(iii) All newborn children born on or after October 1, 1984, to a woman who is eligible as medically needy and receiving Medicaid on the date of the child's birth. The child is deemed to have applied and been found eligible for Medicaid on the date of birth and remains eligible as medically needy for ne year so long as the woman remains eligible and the child is a member of the woman's household. If the woman's basis of eligibility changes to categorically needy, the child is eligible as categorically needy under § 436.124. The woman is considered to remain eligible if she meets the spend-down requirements in any consecutive budget period following the birth of the child.
(iv) Women who, while pregnant, applied for, were eligible for, and received Medicaid services as medically needed on the day that their pregnancy ends. The agency must provide medically needy eligibility to these women for an extended period following termination of pregnancy. This period begins on the last day of the pregnancy and extends through the end of the month in which a 60-day period following termination of pregnancy ends. Eligibility must be provided, regardless of changes in the women's financial circumstances that may occur within this extended period. These women are eligible for the extended period for all services under the plan that are pregnancy-related (as defined in § 440.210(c)(1) of this subchapter).
(2) The agency may provide Medicaid to any or all of the following groups of individuals:
(i) Individuals under age 21 (§ 436.308).
(ii) Specified relatives (§ 436.310).
(iii) Aged (§ 436.320).
(iv) Blind (§ 436.321).
(v) Disabled (§ 436.322).
(3) If the agency provides Medicaid to any individual in a group specified in paragraph (b)(2) of this section, the agency must provide Medicaid to all individuals eligible to be members of that group.
(a) If the agency provides Medicaid to the medically needy, it may provide Medicaid to individuals under age 21 (or at State option, under age 20, 19, or 18) as specified in paragraph (b) of this section:
(1) Who would not be covered under the mandatory medically needy group of individuals under 18 under § 436.301(b)(1)(ii); and
(2) Who meet the income and resource requirements of subpart I of this part.
(b) The agency may cover all individuals in paragraph (a) of this section or individuals in reasonable classifications. Examples of reasonable classifications are as follows:
(1) Individuals in foster homes or private institutions for whom a public agency is assuming a full or partial financial responsibility. If the agency covers these individuals, it may also provide Medicaid to individuals placed in foster homes or private institutions by private nonprofit agencies.
(2) Individuals in adoptions subsidized in full or in part by a public agency.
(3) Individuals in nursing facilities when nursing facility services are provided under the plan to individuals within the age group selected under this provision. When the agency covers such individuals, it may also provide Medicaid to individuals in intermediate care facilities for the mentally retarded.
(4) Individuals receiving active treatment as inpatients in psychiatric facilities or programs, if inpatient psychiatric services for individuals under 21 are provided under the plan.
(a) If the agency provides for the medically needy, it may provide Medicaid to specified relatives, defined in paragraph (b) of this section, who meet the income and resource requirements of subpart I of this part.
(b)
(1) Are listed under section 406(b)(1) of the Act and in 45 CFR 233.90(c)(1)(v)(A); and
(2) Have in their care an individual who is determined to be (or would, if needy, be) dependent, as specified in § 436.510.
If the agency provides Medicaid to the medically needy, it may provide Medicaid to individuals who—
(a) Are 65 years of age and older, as provided for in § 436.520; and
(b) Meet the income and resource requirements of subpart I of this part.
If the agency provides Medicaid to the medically needy, it may provide Medicaid to blind individuals who meet—
(a) The requirements for blindness, as specified in §§ 436.530 and 436.531; and
(b) The income and resource requirements of subpart I of this part.
If the agency provides Medicaid to the medically needy, it may provide Medicaid to disabled individuals who meet—
(a) The requirements for disability, as specified in §§ 436.540 and 436.541; and
(b) The income and resource requirements of subpart I of this part.
If an agency provides Medicaid to the medically needy, it must provide the services necessary for the treatment of an emergency medical condition, as defined in § 440.255(c) of this chapter to those aliens described in § 436.406(c) of this subpart.
This subpart prescribes general requirements for determining the eligibility of both categorically needy and medically needy individuals specified in subparts B, C, and D of the part.
(a) The agency may not impose any eligibility requirement that is prohibited under title XIX.
(b) The agency must base any optional group covered under subparts B and C of this part on reasonable classifications that do not result in arbitrary or inequitable treatment of individuals and groups and are consistent with the objectives of title XIX.
(c) The agency must not use requirements for determining eligibility for optional coverage groups that are more restrictive than those used under the State plans for OAA, AFDC, AB, APTD, or AABD.
(a)
(b)
(c)
(1) Has an I.Q. of 49 or less or has a mental age of 7 or less, based on tests acceptable to the mental retardation agency in the State;
(2) Is judged legally incompetent; or
(3) Is found incapable of indicating intent based on medical documentation obtained from a physician, psychologist, or other person licensed by the State in the field of mental retardation.
(d)
(1) Meets the conditions in paragraphs (e) through (h) of this section; or
(2) Meets the criteria specified in an interstate agreement under paragraph (j) of this section.
(e)
(2) Any action beyond providing information to the individual and the individual's family would constitute arranging or making a State placement. However, the following actions do not constitute State placement:
(i) Providing basic information to individuals about another State's Medicaid program, and information about the availability of health care services and facilities in another State.
(ii) Assisting an individual in locating an institution in another State provided the individual is capable of indicating intent and independently decides to move.
(3) When a competent individual leaves the facility in which the individual is placed by a State, that individual's State of residency for Medicaid purposes is the State where the individual is physically located.
(4) Where placement is initiated by a State because the State lacks a sufficient number of appropriate facilities to provide services to its residents, the State making the placement is the individual's State of residence for Medicaid purposes.
(f)
(g)
(2) For any individual not residing in an institution as defined in paragraph (b) whose Medicaid eligibility is based on blindness or disability, the State of residence is the State in which the individual is living.
(3) For any other non-institutionalized individual not subject to paragraph (h)(1) or (h)(2) of this section, the State of residence is determined in accordance with 45 CFR 233.40, the rules governing residence under the AFDC program.
(4) For any institutionalized individual who is neither married nor emancipated, the State of residence is—
(i) The parents' or legal guardian's current State of residence at the time of placement; or
(ii) The current State of residence of the parent or legal guardian who files the application, if the individual is institutionalized in that State. If a legal guardian has been appointed and the parental rights are terminated, the State of residence of the guardian is used instead of the parent's.
(iii) The State of residence of the individual or party who files an application is used if the individual has been abandoned by his or her parent(s), does not have a legal guardian and is institutionalized in that State.
(h)
(i) Living with the intention to remain there permanently or for an indefinite period (or if incapable of stating intent, where the individual is living); or
(ii) Living and which the individual entered with a job commitment or seeking employment (whether or not currently employed).
(2) For any institutionalized individual who became incapable of indicating intent before age 21, the State of residence is—
(i) That of the parents applying for Medicaid on the individual's behalf, if the parents reside in separate States;
(ii) The parent's or legal guardian's State of residence at the time of placement; or
(iii) The current State of residence of the parent or legal guardian who files the application, if the individual is institutionalized in that State. If a legal guardian has been appointed and parental rights are terminated, the State of residence of the guardian is used instead of the legal parent's.
(iv) The State of residence of the individual or party who files an application is used if the individual has been abandoned by his or her parent(s), does not have a legal guardian and is institutionalized in that State.
(3) For any institutionalized individual who became incapable of indicating intent at or after age 21, the State of residence is the State in which the individual is physically present, except where another State makes a placement.
(4) For any other institutionalized individual, the State of residence is the State where the individual is living with the intention to remain there permanently or for an indefinite period.
(i)
(2) The agency may not deny Medicaid eligibility to an individual in an institution, who satisfies the residency rules set forth in this section, on the grounds that the individual did not establish residence in the State before entering the institution.
(3) The agency may not deny or terminate a resident's Medicaid eligibility because of that person's temporary absence from the State if the person intends to return when the purpose of the absence has been accomplished, unless another State has determined that the person is a resident there for purposes of Medicaid.
(j)
(k)
(1) The agency must continue to provide Medicaid to that recipient from June 24, 1983 until July 5, 1984 unless it makes arrangements with another State of residence to provide Medicaid at an earlier date; and
(2) Those arrangements must not include provisions prohibited by paragraph (g) of this section.
(l)
The agency must allow an individual who would be eligible under more than
(a) The agency must provide Medicaid to otherwise eligible residents of the United States who are—
(1) Citizens: (i) Under a declaration required by section 1137(d) of the Act that the individual is a citizen or national of the United States; and
(ii) The individual has provided satisfactory documentary evidence of citizenship or national status, as described in § 435.407.
(iii) An individual for purposes of the declaration and citizenship documentation requirements discussed in paragraphs (a)(1)(i) and (a)(1)(ii) of this section includes both applicants and recipients under a section 1115 demonstration (including a family planning demonstration project) for which a State receives Federal financial participation in their expenditures, as though the expenditures were for medical assistance.
(iv) Individuals must declare their citizenship and the State must document an individual's eligibility file on initial applications and initial redeterminations effective July 1, 2006.
(v) The following groups of individuals are exempt from the requirements in paragraph (a)(1)(ii) of this section:
(A) Individuals receiving SSI benefits under title XVI of the Act;
(B) Individuals entitled to or enrolled in any part of Medicare;
(C) Individuals receiving disability insurance benefits under section 223 of the Act or monthly benefits under section 202 of the Act, based on the individual's disability (as defined in section 223(d) of the Act); and
(D) Individuals who are in foster care and who are assisted under Title IV-B of the Act, and individuals who are recipients of foster care maintenance or adoption assistance payments under Title IV-E of the Act.
(2)(i) Except as specified in 8 U.S.C. 1612(b)(1) (permitting States an option with respect to coverage of certain qualified aliens), qualified aliens as described in section 431 of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (8 U.S.C. 1641) (including qualified aliens subject to the 5-year bar) who have provided satisfactory documentary evidence of Qualified Alien status, which status has been verified with the Department of Homeland Security (DHS) under a declaration required by section 1137(d) of the Act that the applicant or recipient is an alien in a satisfactory immigration status.
(ii) The eligibility of qualified aliens who are subject to the 5-year bar in 8 U.S.C. 1613 is limited to the benefits described in paragraph (b) of this section.
(b) The agency must provide payment for the services described in § 440.255(c) of this chapter to residents of the State who otherwise meet the eligibility requirements of the State plan (except for receipt of AFDC, SSI, or State Supplementary payments) who are qualified aliens subject to the 5-year bar or who are non-qualified aliens who meet all Medicaid eligibility criteria, except non-qualified aliens need not present a social security number or document immigration status.
For purposes of this section, the term “citizenship” includes status as a “national of the United States” as defined by section 101(a)(22) of the Immigration and Nationality Act (8 U.S.C. § 1101(a)(22)) to include both citizens of the United States and non-citizen nationals of the United States.
(a)
(1)
(2)
(3)
(4)
(b)
(1) A U.S. public birth certificate showing birth in one of the 50 States, the District of Columbia, Puerto Rico (if born on or after January 13, 1941), Guam (on or after April 10, 1899), the Virgin Islands of the U.S.(on or after January 17, 1917), American Samoa, Swain's Island, or the Northern Mariana Islands (after November 4, 1986 (NMI local time)). A State, at its option, may use a cross match with a State vital statistics agency to document a birth record. The birth record document may be issued by the State, Commonwealth, Territory, or local jurisdiction. It must have been recorded before the person was 5 years of age. A delayed birth record document that is recorded at or after 5 years of age is considered fourth level evidence of citizenship. (
(i)
(A) Evidence of birth in Puerto Rico on or after April 11, 1899 and the applicant's statement that he or she was residing in the U.S., a U.S. possession, or Puerto Rico on January 13, 1941; or
(B) Evidence that the applicant was a Puerto Rican citizen and the applicant's statement that he or she was residing in Puerto Rico on March 1, 1917 and that he or she did not take an oath of allegiance to Spain.
(ii)
(A) Evidence of birth in the U.S. Virgin Islands, and the applicant's statement of residence in the U.S., a U.S. possession, or the U.S. Virgin Islands on February 25, 1927; or
(B) The applicant's statement indicating residence in the U.S. Virgin Islands as a Danish citizen on January 17, 1917 and residence in the U.S., a U.S. possession, or the U.S. Virgin Islands on February 25, 1927, and that he or she did not make a declaration to maintain Danish citizenship; or
(C) Evidence of birth in the U.S. Virgin Islands and the applicant's statement indicating residence in the U.S., a U.S. possession, or Territory or the Canal Zone on June 28, 1932.
(iii)
(A) Evidence of birth in the NMI, TTPI citizenship and residence in the NMI, the U.S., or a U.S. Territory or possession on November 3, 1986 (NMI
(B) Evidence of TTPI citizenship, continuous residence in the NMI since before November 3, 1981 (NMI local time), voter registration before January 1, 1975 and the applicant's statement that he or she did not owe allegiance to a foreign State on November 4, 1986 (NMI local time); or
(C) Evidence of continuous domicile in the NMI since before January 1, 1974 and the applicant's statement that he or she did not owe allegiance to a foreign State on November 4, 1986 (NMI local time).
(D)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
(i) At least one parent of the child is a United States citizen by either birth or naturalization (as verified under the requirements of this Part);
(ii) The child is under the age of 18;
(iii) The child is residing in the United States in the legal and physical custody of the U.S. citizen parent;
(iv) The child was admitted to the United States for lawful permanent residence (as verified under the requirements of 8 U.S.C. 1641 pertaining to verification of qualified alien status); and
(v) If adopted, the child satisfies the requirements of section 101(b)(1) of the Immigration and Nationality Act (8 U.S.C. 1101(b)(1) pertaining to international adoptions (admission for lawful permanent residence as IR-3 (child adopted outside the United States)), or as IR-4 (child coming to the United States to be adopted) with final adoption having subsequently occurred).
(c)
(1) Extract of a hospital record on hospital letterhead established at the time of the person's birth that was created 5 years before the initial application date and that indicates a U.S. place of birth. (For children under 16 the document must have been created near the time of birth or 5 years before the date of application.) Do not accept a souvenir “birth certificate” issued by the hospital.
(2) Life, health, or other insurance record showing a U.S. place of birth that was created at least 5 years before the initial application date that indicates a U.S. place of birth. (For children under 16 the document must have been created near the time of birth or 5 years before the date of application.) Life or health insurance records may show biographical information for the person including place of birth; the record can be used to establish U.S. citizenship when it shows a U.S. place of birth.
(3) Religious record recorded in the U.S. within 3 months of birth showing the birth occurred in the U.S. and showing either the date of the birth or the individual's age at the time the record was made. The record must be an official record recorded with the religious organization. Caution: In questionable cases (for example, where the child's religious record was recorded near a U.S. international border and the child may have been born outside the U.S.), the State must consider verifying the religious record and/or documenting that the mother was in the U.S. at the time of the birth.
(4) Early school record showing a U.S. place of birth. The school record must show the name of the child, the date of admission to the school, the date of birth (or age at the time the record was made), a U.S. place of birth,
(d)
(1)
(2) One of the following documents that show a U.S. place of birth and was created at least 5 years before the application for Medicaid. (For children under 16 the document must have been created near the time of birth or 5 years before the date of application.) This document must be one of the following and show a U.S. place of birth:
(i) Seneca Indian tribal census.
(ii) Bureau of Indian Affairs tribal census records of the Navajo Indians.
(iii) U.S. State Vital Statistics official notification of birth registration.
(iv) A delayed U.S. public birth record that is recorded more than 5 years after the person's birth.
(v) Statement signed by the physician or midwife who was in attendance at the time of birth.
(vi) The Roll of Alaska Natives maintained by the Bureau of Indian Affairs.
(3) Institutional admission papers from a nursing facility, skilled care facility or other institution created at least 5 years before the initial application date that indicates a U.S. place of birth. Admission papers generally show biographical information for the person including place of birth; the record can be used to establish U.S. citizenship when it shows a U.S. place of birth.
(4) Medical (clinic, doctor, or hospital) record created at least 5 years before the initial application date that indicates a U.S. place of birth. (For children under 16 the document must have been created near the time of birth or 5 years before the date of application.) Medical records generally show biographical information for the person including place of birth; the record can be used to establish U.S. citizenship when it shows a U.S. place of birth. (
(5)
(i) There must be at least two affidavits by two individuals who have personal knowledge of the event(s) establishing the applicant's or recipient's claim of citizenship (the two affidavits could be combined in a joint affidavit).
(ii) At least one of the individuals making the affidavit cannot be related to the applicant or recipient. Neither of the two individuals can be the applicant or recipient.
(iii) In order for the affidavit to be acceptable the persons making them must be able to provide proof of their own citizenship and identity.
(iv) If the individual(s) making the affidavit has (have) information which explains why documentary evidence establishing the applicant's claim or citizenship does not exist or cannot be readily obtained, the affidavit should contain this information as well.
(v) The State must obtain a separate affidavit from the applicant/recipient or other knowledgeable individual (guardian or representative) explaining why the evidence does not exist or cannot be obtained.
(vi) The affidavits must be signed under penalty of perjury and need not be notarized.
(e)
(1) Identity documents described in 8 CFR 274a.2(b)(1)(v)(B)(1).
(i) Driver's license issued by State or Territory either with a photograph of the individual or other identifying information of the individual such as name, age, sex, race, height, weight, or eye color.
(ii) School identification card with a photograph of the individual.
(iii) U.S. military card or draft record.
(iv) Identification card issued by the Federal, State, or local government with the same information included on driver's licenses.
(v) Military dependent's identification card.
(vi) Certificate of Degree of Indian Blood, or other American Indian/Alaska Native Tribal document with a photograph or other personal identifying information relating to the individual. Acceptable if the document carries a photograph of the applicant or recipient, or has other personal identifying information relating to the individual such as age, weight, height, race, sex, and eye color.
(vii) U.S. Coast Guard Merchant Mariner card.
Exception: Do not accept a voter's registration card or Canadian driver's license as listed in 8 CFR 274a.2(b)(1)(v)(B)(1). CMS does not view these as reliable for identity.
(2) At State option, a State may use a cross match with a Federal or State governmental, public assistance, law enforcement or corrections agency's data system to establish identity if the agency establishes and certifies true identity of individuals. Such agencies may include food stamps, child support, corrections, including juvenile detention, motor vehicle, or child protective services. The State Medicaid Agency is still responsible for assuring the accuracy of the identity determination.
(3) At State option, a State may accept three or more documents that together reasonably corroborate the identity of an individual provided such documents have not been used to establish the individual's citizenship and the individual submitted second or third tier evidence of citizenship. The State must first ensure that no other evidence of identity is available to the individual prior to accepting such documents. Such documents must at a minimum contain the individual's name, plus any additional information establishing the individual's identity. All documents used must contain consistent identifying information. These documents include employer identification cards, high school and college diplomas from accredited institutions (including general education and high school equivalency diplomas), marriage certificates, divorce decrees, and property deeds/titles.
(f)
(g)
(h)
(i)
(2) States must maintain copies of citizenship and identification documents in the case record or electronic data base and make these copies available for compliance audits.
(3) States may permit applicants and recipients to submit such documentary evidence without appearing in person at a Medicaid office. States may accept original documents in person, by mail, or by a guardian or authorized representative.
(4) If documents are determined to be inconsistent with pre-existing information, are counterfeit, or altered, States should investigate for potential fraud and abuse, including but not limited to, referral to the appropriate State and Federal law enforcement agencies.
(5) Presentation of documentary evidence of citizenship is a one time activity; once a person's citizenship is documented and recorded in a State database subsequent changes in eligibility should not require repeating the documentation of citizenship unless later evidence raises a question of the person's citizenship. The State need only check its databases to verify that the individual already established citizenship.
(6) CMS requires that as a check against fraud, using currently available automated capabilities, States will conduct a match of the applicant's name against the corresponding Social Security number that was provided. In addition, in cooperation with other agencies of the Federal government, CMS encourages States to use automated capabilities to verify citizenship and identity of Medicaid applicants. Automated capabilities may fall within the computer matching provisions of the Privacy Act of 1974, and CMS will explore any implementation issues that may arise with respect to those requirements. When these capabilities become available, States will be required to match files for individuals who used third or fourth tier documents to verify citizenship and documents to verify identity, and CMS will make available to States necessary information in this regard. States must ensure that all case records within this category will be so identified and made available to conduct these automated matches. CMS may also require States to match files for individuals who used first or second level documents to verify citizenship as well. CMS may provide further guidance to States with respect to actions required in a case of a negative match.
(j)
(k)
This subpart prescribes categorical requirements for determining the eligibility of both categorically needy and medically needy individuals specified in subparts B, C, and D of this part.
For families with dependent children who are not receiving AFDC, the agency must use the definitions and procedures used under the State's AFDC plan to determine whether—
(a) An individual is a dependent child because he is deprived of parental support or care; and
(b) An individual is an eligible member of a family with dependent children.
The agency must not impose an age requirement of more than 65 years.
(a) In determining age, the agency must use the common law method (under which an age is reached the day before the anniversary of birth) or the popular usage method (under which a specific age is reached on the anniversary of birth), whichever is used under the corresponding State plan for OAA, AFDC, AB, APTD, or AABD.
(b) The agency may use an arbitrary date, such as July 1, for determining an individual's age if the year, but not the month, of his birth is known.
(a)
(b)
In determining blindness—
(a) A physician skilled in the diseases of the eye or an optometrist, whichever the individual selects, must examine him, unless both of the applicant's eyes are missing;
(b) The examiner must submit a report of examination to the Medicaid agency; and
(c) A physician skilled in the diseases of the eye (for example, an ophthalmologist or an eye, ear, nose, and throat specialist) must review the report and determine on behalf of the agency—
(1) Whether the individual meets the definition of blindness; and
(2) Whether and when reexaminations are necessary for periodic redeterminations of eligibility, as required under § 435.916 of this subchapter. Blindness is considered to continue until the reviewing physician determines that the recipient's vision no longer meets the definition.
(a)
(b)
(a)
(2) If the requirements or determining disability under the State's APTD or AABD program are more restrictive than the minimum requirements specified in this section, the agency must use the requirements applied under the APTD or AABD program.
(b) The agency must obtain a medical report and a social history for individuals applying for Medicaid on the basis of disability. The medical report must include a diagnosis based on medical
(c) A physician and social worker, qualified by professional training and experience, must review the medical report and social history and determine on behalf of the agency whether the individual meets the definition of disability. The physician must determine whether and when reexaminations will be necessary for periodic redeterminations of eligibility as required under § 435.916 of this subchapter.
(d) In subsequently determining disability, the physician and social worker must review reexamination reports and the social history and determine whether the individual continues to meet the definition. Disability is considered to continue until this determination is made.
This subpart prescribes:
(a) General financial requirements and options for determining the eligibility of both categorically needy and medically needy individuals specified in subparts B, C, and D of this part. Subparts H and I of this part prescribe additional financial requirements.
(b) [Reserved]
(a)
(b)
(c)
(d)
(i) Qualified pregnant women and children under the mandatory categorically needy group under § 436.120;
(ii) Low-income pregnant women, infants, and children specified in section 1902(a)(10)(i) (IV), (VI), and (VII) of the Act;
(iii) Qualified Medicare beneficiaries specified in sections 1902(a)(10)(E) and 1905(p) of the Act;
(iv) Optional categorically needy individuals under groups established under subpart C of this part and section 1902(a)(10)(A)(ii) of the Act; and
(v) Medically needy individuals under groups established under subpart D of this part and section 1902(a)(10)(C)(i)(III) of the Act.
(2) The income and resource methodologies that an agency elects to apply to groups of individuals under paragraph (c)(1) of this section may be less restrictive, but no more restrictive, than:
(i) For groups of aged, blind, and disabled individuals, the SSI methodologies; or
(ii) For all other groups, the methodologies under the State plan most closely categorically related to the individual's status.
(3) A financial methodology is considered to be no more restrictive if, by using the methodology, additional individuals may be eligible for Medicaid and no individuals who are otherwise eligible are by use of that methodology made ineligible for Medicaid.
(4) The less restrictive methodology applied under this section must be comparable for all persons within each category of assistance (aged, or blind,
(5) The application of the less restrictive income and resource methodologies permitted under this section must be consistent with the limitations and conditions on FFP specified in subpart K of this part.
(e) [Reserved]
(f)
(2) If the agency chooses to apply less restrictive income and resource methodologies, the State plan must specify:
(i) The less restrictive methodologies that will used; and
(ii) The eligibility groups or groups to which the less restrictive methodologies will be applied.
(a) Subject to the provisions of paragraphs (b) and (c) of this section, in determining financial responsibility of relatives and other persons for individuals under Medicaid, the agency must use the following financial eligibility requirements and methodologies.
(1) Except for a spouse of an individual or a parent for a child who is under age 21 or blind or disabled, the agency must not consider income and resources of any relative as available to an individual.
(2) In relation to individuals under 21 (as described in section 1905(a)(i) of the Act), the financial responsibility requirements and methodologies include considering the income and resources of parents or spouses whose income and resources would be considered if the individual under age 21 were dependent under the State's approved AFDC plan, whether or not they are actually contributed. These requirements and methodologies must be applied in accordance with provisions of the State's approved AFDC plan.
(3) When a couple ceases to live together, the agency must count only the income and resources of the individual in determining his or her eligibility, beginning the first month following the month the couple ceases to live together.
(b) The agency may apply income and resource methodologies that are less restrictive than the cash assistance methodologies as specified in the State plan in accordance with § 436.601(d).
(c) [Reserved]
(a) As a condition of eligibility, the agency must require applicants and recipients to take all necessary steps to obtain any annuities, pensions, and retirement and disability benefits to which they are entitled, unless they can show good cause for not doing so.
(b) Annuities, pensions, and retirement and disability benefits include, but are not limited to, veterans' compensation and pensions, OASDI benefits, railroad retirement benefits, and unemployment compensation.
(a) As a condition of eligibility, the agency must require legally able applicants and recipients to:
(1) Assign rights to the Medicaid agency to medical support and to payment for medical care from any third party;
(2) Cooperate with the agency in establishing paternity and in obtaining medical support and payments, unless the individual establishes good cause for not cooperating, and except for individuals described in section
(3) Cooperate in identifying and providing information to assist the Medicaid agency in pursuing third parties who may be liable to pay for care and services under the plan, unless the individual establishes good cause for not cooperating.
(b) The requirements for assignment of rights must be applied uniformly for all groups covered under the plan.
(c) The requirements of paragraph (a) of this section for assignment of rights to medical support and other payments and cooperation in obtaining medical support and payments are effective for medical assistance furnished on or after October 1, 1984. The requirement for cooperation in identifying and providing information for pursuing liable third parties is effective for medical assistance furnished on or after July 1, 1986.
This subpart prescribes financial requirements for determining the eligibility of medically needy individuals under subpart D of this part.
(a) To determine eligibility of medically needy individuals, the agency must use a single income standard for all covered medically needy groups that meets the requirements of this section.
(b) The income standard must take into account the number of persons in the assistance unit. The standard may not diminish by the number of persons in the unit (for example, if the income level in the standard for an assistance unit of two is set at $400, the income level in the standard for an assistance unit of three may not be less than $400).
(c) The income standard must be set at an amount that is no lower than the lowest income standard used on or after January 1, 1966, to determine eligibility under the cash assistance programs that are related to the State's covered medically needy group or groups of individuals under § 436.301.
(d) The income standard may vary based on the variations between shelter costs in urban areas and rural areas.
The State plan must specify the income standard for the covered medically needy groups.
The agency must determine income eligibility of medically needy individuals in accordance with this section.
(a)
(2) The agency must include in the budget period in which income is computed all or part of the 3-month retroactive period specified in § 435.914. The budget period can begin no earlier then the first month in the retroactive period in which the individual received covered services.
(3) If the agency elects to begin the first budget period for the medically needy in any month of the 3-month period prior to the date of application in which the applicant received covered services, this election applies to all medically needy groups.
(b)
(c)
(d)
(e)
(1) Expenses for Medicare and other health insurance premiums, and deductibles or coinsurance charges, including enrollment fees, copayments, or deductibles imposed under § 447.51 or § 447.53 of this chapter;
(2) Expenses incurred by the individual or family or financially responsible relatives for necessary medical and remedial services that are recognized under State law but not included in the plan;
(3) Expenses incurred by the individual or family or by financially responsible relatives for necessary medical and remedial services that are included in the plan, including those that exceed agency limitations on amount, duration or scope of services;
(f)
(1) For the first budget period or periods that include only months before the month of application for medical assistance, expenses incurred during such period or periods, whether paid or unpaid, to the extent that the expenses have not been deducted previously in establishing eligibility;
(2) For the first prospective budget period that also includes any of the 3 months before the month of application for medical assistance, expenses incurred during such budget period, whether paid or unpaid, to the extent that the expenses have not been deducted previously in establishing eligibility;
(3) For the first prospective budget period that includes none of the months preceding the month of application, expenses incurred during such budget period and any of the 3 preceding months, whether paid or unpaid, to the extent that the expenses have not been deducted previously in establishing eligibility;
(4) For any of the 3 months preceding the month of application that are not includable under paragraph (f)(2) of this section, expenses incurred in the 3-month period that were a current liability of the individual in any such month for which a spenddown calculation is made and that had not been previously deducted from income in establishing eligibility for medical assistance;
(5) Current payments (that is, payments made in the current budget period) on other expenses incurred before the current budget period and not previously deducted from income in any budget period in establishing eligibility for such period; and
(6) If the individual's eligibility for medical assistance was established in each such preceding period, expenses incurred before the current budget period but not previously deducted from income, to the extent that such expenses are unpaid and are:
(i) Described in paragraphs (e)(1) through (e)(3) of this section; and
(ii) Are carried over from the preceding budget period or periods because the individual had a spenddown liability in each such preceding period that was met without deducting all such incurred, unpaid expenses.
(g)
(1) May include medical institutional expenses (other than expenses in acute care facilities) projected to the end of the budget period at the Medicaid reimbursement rate;
(2) May, to the extent determined by the agency and specified in its approved plan, include expenses incurred earlier than the third month before the month of application; and
(3) May set reasonable limits on the amount to be deducted for expenses specified in paragraphs (e)(1), (e)(2), and (g)(2) of this section.
(h)
(1)
(i) Cost-sharing expenses as specified in paragraph (e)(1) of this section.
(ii) Services not included in the State plan as specified in paragraph (e)(2) of this section.
(iii) Services included in the State plan as specified in paragraph (e)(3) of this section but that exceed agency limitations on amount, duration, or scope of services.
(iv) Services included in the State plan as specified in paragraph (e)(3) of this section but that are within agency limitations on amount, duration, or scope of services.
(2)
(3)
(i)
(i) If his or her spenddown liability is met after the first day of the budget period; and
(ii) If beginning eligibility after the first day of the budget period makes the individual's share of health care expenses under § 436.832 greater than the individual's contributable income determined under this section.
(2) At the end of the prospective period specified in paragraph (f)(2) or (f)(3) of this section and any subsequent prospective period or, if earlier, when any significant change occurs, the agency must reconcile the projected amounts with the actual amounts incurred, or with changes in circumstances, to determine if the adjusted deduction of incurred expenses reduces income to the income standard.
(3) Except as provided in paragraph (i)(1) of this section, if agencies elect partial month coverage, an individual is eligible for Medicaid on the day that the deduction of incurred health care expenses (and of projected institutional expenses if the agency elects the option under paragraph (g)(1) of this section) reduces income to the income standard.
(4) Except as provided in paragraph (i)(1) of this section, if agencies elect full month coverage, an individual is eligible on the first day of the month in which spenddown liability is met.
(5) Expenses used to meet spenddown liability are not reimbursable under Medicaid. Therefore, to the extent necessary to prevent the transfer of an individual's spenddown liability to the Medicaid program, States must reduce the amount of provider charges that would otherwise be reimbursable under Medicaid.
(a)
(2) The individual's income must be determined in accordance with paragraph (e) of this section.
(3) Medical expenses must be determined in accordance with paragraph (f) of this section.
(b)
(c)
(1)
(i) $30 a month for an aged, blind, or disabled individual, including a child applying for Medicaid on the basis of blindness or disability;
(ii) $60 a month for an institutionalized couple if both spouses are aged, blind, or disabled and their income is considered available to each other in determining eligibility; and
(iii) For other individuals, a reasonable amount set by the agency, based on a reasonable difference in their personal needs from those of the aged, blind, or disabled.
(2)
(i) The amount of the highest need standard for an individual without income and resources under the State's approved plan for OAA, AFDC, AB, APTD, or AABD; or
(ii) The amount of the highest medically needy income standard for one person established under § 436.811.
(3)
(i) Be based on a reasonable assessment of their financial need;
(ii) Be adjusted for the number of family members living in the home; and
(iii) Not exceed the highest of the following need standards for a family of the same size:
(A) The standard used to determine eligibility under the State's Medicaid plan, as provided for in § 436.811.
(B) The standard used to determine eligibility under the State's approved AFDC plan.
(4)
(i) Medicare and other health insurance premiums, deductibles, or coinsurance charges; and
(ii) Necessary medical or remedial care recognized under State law but not covered under the State's Medicaid plan, subject to reasonable limits the agency may establish on amounts of these expenses.
(d)
(1) The amount is deducted for not more than a 6-month period; and
(2) A physician has certified that either of the individuals is likely to return to the home within that period.
(e)
(2)
(3)
(f)
(2)
(3)
(a) To determine eligibility of medically needy individuals, the Medicaid agency must use a single resource standard that is set at an amount that is no lower than the lowest resource standard used on or after January 1, 1966, to determine eligibility under the cash assistance programs that are related to the State's covered medically needy group or groups of individuals under § 436.301.
(b) The resource standard established under paragraph (a) of this section may not diminish by an increase in the number of persons in the assistance unit. For example, the resource level in the standard for an assistance unit of three may not be less than that set for an assistance unit of two.
The State plan must specify the resource standard for the covered medically needy groups.
To determine eligibility on the basis of resources for medically needy individuals, the agency must—
(a) Consider only the individual's resources and those that are considered available to him under the financial responsibility requirements for relatives under § 436.602;
(b) Consider only resources available during the period for which income is computed under § 436.831(a);
(c) Deduct the value of resources that would be deducted in determining eligibility under the State's plan for OAA, AFDC, AB, APTD, or AABD or under the State's less restrictive financial methodology specified in the State Medicaid plan in accordance with § 436.601. In determining the amount of an individual's resources for Medicaid eligibility, States must count amounts of resources that otherwise would not be counted under the conditional eligibility provisions of the AFDC program.
(d) Apply the resource standards established under § 436.840.
This subpart sets forth requirements for processing applications, determining eligibility, and furnishing Medicaid.
The Medicaid agency must comply with all the requirements of part 435, subpart J, of this subchapter, except those specified in § 435.909.
The agency may not require a separate application for Medicaid from an individual if the individual receives cash assistance under a State plan for OAA, AFDC, AB, APTD, or AABD.
This subpart specifies when, and the extent to which, FFP is available in expenditures for determining eligibility and for Medicaid services to individuals determined eligible under this part, and prescribes limitations and conditions on FFP for those expenditures.
(a) FFP is available in the necessary administrative costs the State incurs in—
(1) Determining and redetermining Medicaid eligibility and in providing Medicaid to eligible individuals; and
(2) Determining presumptive eligibility for children and providing services to presumptively eligible children.
(b) Administrative costs include any costs incident to an eye examination or medical examination to determine whether an individual is blind or disabled.
(a) FFP is available in expenditures for Medicaid services for all recipients whose coverage is required or allowed under this part.
(b) FFP is available in expenditures for services provided to recipients who were eligible for Medicaid in the month in which the medical care or services were provided, except that, for recipients who establish eligibility for Medicaid by deducting incurred medical expenses from income, FFP is not available for expenses that are the recipient's liability.
(c) FFP is available in expenditures for services covered under the plan that are furnished—
(1) To children who are determined by a qualified entity to be presumptively eligible;
(2) During a period of presumptive eligibility;
(3) By a provider that is eligible for payment under the plan; and
(4) Regardless of whether the children are determined eligible for Medicaid following the period of presumptive eligibility.
FFP is available for a temporary period specified in the State plan in expenditures for services provided to recipients who are overcoming certain eligibility conditions, including blindness, disability, continued absence or incapacity of a parent, or unemployment of a parent.
Except for individuals described in § 436.406(a)(1)(v), FFP will not be available to a State with respect to expenditures for medical assistance furnished to individuals unless the State has obtained satisfactory documentary evidence of citizenship or national status, as described in § 436.407 of this chapter that complies with the requirements of section 1903(x) of the Act.
(a) FFP is not available in expenditures for services provided to—
(1) Individuals who are inmates of public institutions as defined in § 435.1010 of this chapter; or
(2) Individuals under age 65 who are patients in an institution for mental diseases unless they are under age 22 and are receiving inpatient psychiatric services under § 440.160 of this subchapter.
(b) The exclusion of FFP described in paragraph (a) of this section does not apply during that part of the month in which the individual is not an inmate of a public institution or a patient in an institution for mental diseases.
(c) An individual on conditional release or convalescent leave from an institution for mental diseases is not considered to be a patient in that institution. However, such an individual who is under age 22 and has been receiving inpatient pyschiatric services under § 440.160 of this subchapter is considered to be a patient in the institution until he is unconditionally released or, if earlier, the date he reaches age 22.
For purposes of FFP, the definitions in § 435.1010 of this chapter apply to this part.
(a)
(b)
(1) In the case of a child on whose behalf a Medicaid application has been filed, the day on which a decision is made on that application; or
(2) In the case of a child on whose behalf a Medicaid application has not been filed, the last day of the month following the month in which the determination of presumptive eligibility was made.
(1) Furnishes health care items and services covered under the approved plan and is eligible to receive payments under the approved plan;
(2) Is authorized to determine eligibility of a child to participate in a Head Start program under the Head Start Act;
(3) Is authorized to determine eligibility of a child to receive child care services for which financial assistance is provided under the Child Care and Development Block Grant Act of 1990;
(4) Is authorized to determine eligibility of an infant or child to receive
(5) Is authorized to determine eligibility of a child for medical assistance under the Medicaid State plan, or eligibility of a child for child health assistance under the State Children's Health Insurance Program;
(6) Is an elementary or secondary school, as defined in section 14101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 8801);
(7) Is an elementary or secondary school operated or supported by the Bureau of Indian Affairs;
(8) Is a State or Tribal child support enforcement agency;
(9) Is an organization that—
(i) Provides emergency food and shelter under a grant under the Stewart B. McKinney Homeless Assistance Act;
(ii) Is a State or Tribal office or entity involved in enrollment in the program under this title, Part A of title IV, or title XXI; or
(iii) Determines eligibility for any assistance or benefits provided under any program of public or assisted housing that receives Federal funds, including the program under section 8 or any other section of the United States Housing Act of 1937 (42 U.S.C. 1437) or under the Native American Housing Assistance and Self Determination Act of 1996 (25 U.S.C. 4101
(10) Any other entity the State so deems, as approved by the Secretary.
(a) The agency may provide services to children under age 19 during one or more periods of presumptive eligibility following a determination made by a qualified entity that the child's estimated gross family income or, at the State's option, the child's estimated family income after applying simple disregards, does not exceed the applicable income standard.
(b) If the agency elects to provide services to children during a period of presumptive eligibility, the agency must—
(1) Provide qualified entities with application forms for Medicaid and information on how to assist parents, caretakers and other persons in completing and filing such forms;
(2) Establish procedures to ensure that qualified entities—
(i) Notify the parent or caretaker of the child at the time a determination regarding presumptive eligibility is made, in writing and orally if appropriate, of such determination;
(ii) Provide the parent or caretaker of the child with a Medicaid application form;
(iii) Within 5 working days after the date that the determination is made, notify the agency that a child is presumptively eligible;
(iv) For children determined to be presumptively eligible, notify the child's parent or caretaker at the time the determination is made, in writing and orally if appropriate, that—
(A) If a Medicaid application on behalf of the child is not filed by the last day of the following month, the child's presumptive eligibility will end on that last day; and
(B) If a Medicaid application on behalf of the child is filed by the last day of the following month, the child's presumptive eligibility will end on the day that a decision is made on the Medicaid application; and
(v) For children determined not to be presumptively eligible, notify the child's parent or caretaker at the time the determination is made, in writing and orally if appropriate—
(A) Of the reason for the determination; and
(B) That he or she may file an application for Medicaid on the child's behalf with the Medicaid agency; and
(3) Provide all services covered under the plan, including EPSDT.
(4) Allow determinations of presumptive eligibility to be made by qualified entities on a Statewide basis.
(c) The agency must adopt reasonable standards regarding the number of periods of presumptive eligibility that will be authorized for a child in a given time frame.
Sec. 1102 of the Social Security Act (42 U.S.C. 1302).
(a)
(1) Section 1902(a)(4) requires that States provide for methods of administration that the Secretary finds necessary for proper and efficient operation of the State plan. The application of the requirements of this part to PIHPs and PAHPs that do not meet the statutory definition of an MCO or a PCCM is under the authority in section 1902(a)(4).
(2) Section 1903(m) contains requirements that apply to comprehensive risk contracts.
(3) Section 1903(m)(2)(H) provides that an enrollee who loses Medicaid eligibility for not more than 2 months may be enrolled in the succeeding month in the same MCO or PCCM if that MCO or PCCM still has a contract with the State.
(4) Section 1905(t) contains requirements that apply to PCCMs.
(5) Section 1932—
(i) Provides that, with specified exceptions, a State may require Medicaid recipients to enroll in MCOs or PCCMs;
(ii) Establishes the rules that MCOs, PCCMs, the State, and the contracts between the State and those entities must meet, including compliance with requirements in sections 1903(m) and 1905(t) of the Act that are implemented in this part;
(iii) Establishes protections for enrollees of MCOs and PCCMs;
(iv) Requires States to develop a quality assessment and performance improvement strategy;
(v) Specifies certain prohibitions aimed at the prevention of fraud and abuse;
(vi) Provides that a State may not enter into contracts with MCOs unless it has established intermediate sanctions that it may impose on an MCO that fails to comply with specified requirements; and
(vii) Makes other minor changes in the Medicaid program.
(b)
As used in this part—
(1) Outpatient hospital services.
(2) Rural health clinic services.
(3) FQHC services.
(4) Other laboratory and X-ray services.
(5) Nursing facility (NF) services.
(6) Early and periodic screening, diagnostic, and treatment (EPSDT) services.
(7) Family planning services.
(8) Physician services.
(9) Home health services.
(1) Through payments to, or arrangements with, providers;
(2) Under a comprehensive risk contract with the State; and
(3) Meets the following criteria—
(i) First became operational prior to January 1, 1986; or
(ii) Is described in section 9517(e)(3) of the Omnibus Budget Reconciliation Act of 1985 (as amended by section 4734 of the Omnibus Budget Reconciliation Act of 1990).
(1) A Federally qualified HMO that meets the advance directives requirements of subpart I of part 489 of this chapter; or
(2) Any public or private entity that meets the advance directives requirements and is determined to also meet the following conditions:
(i) Makes the services it provides to its Medicaid enrollees as accessible (in terms of timeliness, amount, duration, and scope) as those services are to other Medicaid recipients within the area served by the entity.
(ii) Meets the solvency standards of § 438.116.
(1) Is not at financial risk for changes in utilization or for costs incurred under the contract that do not exceed the upper payment limits specified in § 447.362 of this chapter; and
(2) May be reimbursed by the State at the end of the contract period on the basis of the incurred costs, subject to the specified limits.
(1) Provides medical services to enrollees under contract with the State agency, and on the basis of prepaid capitation payments, or other payment arrangements that do not use State plan payment rates;
(2) Does not provide or arrange for, and is not otherwise responsible for the provision of any inpatient hospital or institutional services for its enrollees; and
(3) Does not have a comprehensive risk contract.
(1) Provides medical services to enrollees under contract with the State agency, and on the basis of prepaid capitation payments, or other payment arrangements that do not use State plan payment rates;
(2) Provides, arranges for, or otherwise has responsibility for the provision of any inpatient hospital or institutional services for its enrollees; and
(3) Does not have a comprehensive risk contract.
(1) A physician assistant.
(2) A nurse practitioner.
(3) A certified nurse-midwife.
(1) Assumes risk for the cost of the services covered under the contract; and
(2) Incurs loss if the cost of furnishing the services exceeds the payments under the contract.
(a)
(b)
(1) An MCO.
(2) The entities identified in section 1903(m)(2)(B)(i), (ii), and (iii) of the Act.
(3) Community, Migrant, and Appalachian Health Centers identified in section 1903(m)(2)(G) of the Act. Unless they qualify for a total exemption under section 1903(m)(2)(B) of the Act, these entities are subject to the regulations governing MCOs under this part.
(4) An HIO that arranges for services and became operational before January 1986.
(5) An HIO described in section 9517(c)(3) of the Omnibus Budget Reconciliation Act of 1985 (as added by section 4734(2) of the Omnibus Budget Reconciliation Act of 1990).
(c)
(i)
(A) Have been developed in accordance with generally accepted actuarial principles and practices;
(B) Are appropriate for the populations to be covered, and the services to be furnished under the contract; and
(C) Have been certified, as meeting the requirements of this paragraph (c), by actuaries who meet the qualification standards established by the American Academy of Actuaries and follow the practice standards established by the Actuarial Standards Board.
(ii)
(iii)
(iv)
(v)
(2)
(ii) The contract must specify the payment rates and any risk-sharing mechanisms, and the actuarial basis for computation of those rates and mechanisms.
(3)
(i) Base utilization and cost data that are derived from the Medicaid population, or if not, are adjusted to make them comparable to the Medicaid population.
(ii) Adjustments made to smooth data and adjustments to account for factors such as medical trend inflation, incomplete data, MCO, PIHP, or PAHP administration (subject to the limits in paragraph (c)(4)(ii) of this section), and utilization;
(iii) Rate cells specific to the enrolled population, by—
(A) Eligibility category;
(B) Age;
(C) Gender;
(D) Locality/region; and
(E) Risk adjustments based on diagnosis or health status (if used).
(iv) Other payment mechanisms and utilization and cost assumptions that are appropriate for individuals with chronic illness, disability, ongoing health care needs, or catastrophic claims, using risk adjustment, risk sharing, or other appropriate cost-neutral methods.
(4)
(i) The actuarial certification of the capitation rates.
(ii) An assurance (in accordance with paragraph (c)(3) of this section) that all payment rates are—
(A) Based only upon services covered under the State plan (or costs directly related to providing these services, for example, MCO, PIHP, or PAHP administration).
(B) Provided under the contract to Medicaid-eligible individuals.
(iii) The State's projection of expenditures under its previous year's contract (or under its FFS program if it did not have a contract in the previous year) compared to those projected under the proposed contract.
(iv) An explanation of any incentive arrangements, or stop-loss, reinsurance, or any other risk-sharing methodologies under the contract.
(5)
(ii) If risk corridor arrangements result in payments that exceed the approved capitation rates, these excess payments will not be considered actuarially sound to the extent that they result in total payments that exceed the amount Medicaid would have paid, on a fee-for-service basis, for the State plan services actually furnished to enrolled individuals, plus an amount for MCO, PIHP, or PAHP administrative costs directly related to the provision of these services.
(iii) Contracts with incentive arrangements may not provide for payment in excess of 105 percent of the approved capitation payments attributable to the enrollees or services covered by the incentive arrangement, since such total payments will not be considered to be actuarially sound.
(iv) For all incentive arrangements, the contract must provide that the arrangement is—
(A) For a fixed period of time;
(B) Not to be renewed automatically;
(C) Made available to both public and private contractors;
(D) Not conditioned on intergovernmental transfer agreements; and
(E) Necessary for the specified activities and targets.
(v) If a State makes payments to providers for graduate medical education (GME) costs under an approved State plan, the State must adjust the actuarially sound capitation rates to account for the GME payments to be made on behalf of enrollees covered under the contract, not to exceed the aggregate amount that would have been paid under the approved State plan for FFS. States must first establish actuarially sound capitation rates prior to making adjustments for GME.
(d)
(1) The MCO, PIHP, PAHP, or PCCM accepts individuals eligible for enrollment in the order in which they apply without restriction (unless authorized by the Regional Administrator), up to the limits set under the contract.
(2) Enrollment is voluntary, except in the case of mandatory enrollment programs that meet the conditions set forth in § 438.50(a).
(3) The MCO, PIHP, PAHP, or PCCM will not, on the basis of health status or need for health care services, discriminate against individuals eligible to enroll.
(4) The MCO, PIHP, PAHP, or PCCM will not discriminate against individuals eligible to enroll on the basis of race, color, or national origin, and will not use any policy or practice that has the effect of discriminating on the basis of race, color, or national origin.
(e)
(f)
(1) Comply with all applicable Federal and State laws and regulations including title VI of the Civil Rights Act of 1964; title IX of the Education Amendments of 1972 (regarding education programs and activities); the Age Discrimination Act of 1975; the Rehabilitation Act of 1973; and the Americans with Disabilities Act; and
(2) Meet all the requirements of this section.
(g)
(h)
(2) In applying the provisions of §§ 422.208 and 422.210 of this chapter, references to “M+C organization”, “CMS”, and “Medicare beneficiaries” must be read as references to “MCO, PIHP, or PAHP”, “State agency” and “Medicaid recipients”, respectively.
(i)
(2) All PAHP contracts must provide for compliance with the requirements of § 422.128 of this chapter for maintaining written policies and procedures for advance directives if the PAHP includes, in its network, any of those providers listed in § 489.102(a) of this chapter.
(3) The MCO, PIHP, or PAHP subject to this requirement must provide adult enrollees with written information on advance directives policies, and include a description of applicable State law.
(4) The information must reflect changes in State law as soon as possible, but no later than 90 days after the effective date of the change.
(j)
(k)
(1) Provide for reasonable and adequate hours of operation, including 24-hour availability of information, referral, and treatment for emergency medical conditions.
(2) Restrict enrollment to recipients who reside sufficiently near one of the manager's delivery sites to reach that site within a reasonable time using available and affordable modes of transportation.
(3) Provide for arrangements with, or referrals to, sufficient numbers of physicians and other practitioners to ensure that services under the contract can be furnished to enrollees promptly and without compromise to quality of care.
(4) Prohibit discrimination in enrollment, disenrollment, and re-enrollment, based on the recipient's health status or need for health care services.
(5) Provide that enrollees have the right to disenroll from their PCCM in accordance with § 438.56(c).
(l)
(m)
(a) The following requirements and options apply to PIHPs, PIHP contracts, and States with respect to PIHPs, to the same extent that they apply to MCOs, MCO contracts, and States for MCOs.
(1) The contract requirements of § 438.6, except for requirements that pertain to HIOs.
(2) The information requirements in § 438.10.
(3) The provision against provider discrimination in § 438.12.
(4) The State responsibility provisions of subpart B of this part except § 438.50.
(5) The enrollee rights and protection provisions in subpart C of this part.
(6) The quality assessment and performance improvement provisions in subpart D of this part to the extent that they are applicable to services furnished by the PIHP.
(7) The grievance system provisions in subpart F of this part.
(8) The certification and program integrity protection provisions set forth in subpart H of this part.
(b) The following requirements and options for PAHPs apply to PAHPs, PAHP contracts, and States.
(1) The contract requirements of § 438.6, except requirements for—
(i) HIOs.
(ii) Advance directives (unless the PAHP includes any of the providers listed in § 489.102) of this chapter.
(2) All applicable portions of the information requirements in § 438.10.
(3) The provision against provider discrimination in § 438.12.
(4) The State responsibility provisions of subpart B of this part except § 438.50.
(5) The provisions on enrollee rights and protections in subpart C of this part.
(6) Designated portions of subpart D of this part.
(7) An enrollee's right to a State fair hearing under subpart E of part 431 of this chapter.
(8) Prohibitions against affiliations with individuals debarred by Federal agencies in § 438.610.
(a)
(b)
(2) The State must have in place a mechanism to help enrollees and potential enrollees understand the State's managed care program.
(3) Each MCO and PIHP must have in place a mechanism to help enrollees and potential enrollees understand the requirements and benefits of the plan.
(c)
(1) Establish a methodology for identifying the prevalent non-English languages spoken by enrollees and potential enrollees throughout the State. “Prevalent” means a non-English language spoken by a significant number or percentage of potential enrollees and enrollees in the State.
(2) Make available written information in each prevalent non-English language.
(3) Require each MCO, PIHP, PAHP, and PCCM to make its written information available in the prevalent non-English languages in its particular service area.
(4) Make oral interpretation services available and require each MCO, PIHP, PAHP, and PCCM to make those services available free of charge to each potential enrollee and enrollee. This applies to all non-English languages, not just those that the State identifies as prevalent.
(5) Notify enrollees and potential enrollees, and require each MCO, PIHP, PAHP, and PCCM to notify its enrollees—
(i) That oral interpretation is available for any language and written information is available in prevalent languages; and
(ii) How to access those services.
(d)
(i) Use easily understood language and format; and
(ii) Be available in alternative formats and in an appropriate manner that takes into consideration the special needs of those who, for example, are visually limited or have limited reading proficiency.
(2) All enrollees and potential enrollees must be informed that information is available in alternative formats and how to access those formats.
(e)
(i) At the time the potential enrollee first becomes eligible to enroll in a voluntary program, or is first required to enroll in a mandatory enrollment program.
(ii) Within a timeframe that enables the potential enrollee to use the information in choosing among available MCOs, PIHPs, PAHPs, or PCCMs.
(2) The information for potential enrollees must include the following:
(i) General information about—
(A) The basic features of managed care;
(B) Which populations are excluded from enrollment, subject to mandatory enrollment, or free to enroll voluntarily in the program; and
(C) MCO, PIHP, PAHP, and PCCM responsibilities for coordination of enrollee care;
(ii) Information specific to each MCO, PIHP, PAHP, or PCCM program operating in potential enrollee's service area. A summary of the following information is sufficient, but the State must provide more detailed information upon request:
(A) Benefits covered.
(B) Cost sharing, if any.
(C) Service area.
(D) Names, locations, telephone numbers of, and non-English language spoken by current contracted providers, and including identification of providers that are not accepting new patients. For MCOs, PIHPs, and PAHPs, this includes at a minimum information on primary care physicians, specialists, and hospitals.
(E) Benefits that are available under the State plan but are not covered under the contract, including how and where the enrollee may obtain those benefits, any cost sharing, and how transportation is provided. For a counseling or referral service that the MCO, PIHP, PAHP, or PCCM does not cover because of moral or religious objections, the State must provide information about where and how to obtain the service.
(f)
(1) The State must notify all enrollees of their disenrollment rights, at a minimum, annually. For States that choose to restrict disenrollment for periods of 90 days or more, States must send the notice no less than 60 days before the start of each enrollment period.
(2) The State, its contracted representative, or the MCO, PIHP, PAHP, or PCCM must notify all enrollees of their right to request and obtain the information listed in paragraph (f)(6) of this section and, if applicable, paragraphs (g) and (h) of this section, at least once a year.
(3) The State, its contracted representative, or the MCO, PIHP, PAHP, or PCCM must furnish to each of its enrollees the information specified in paragraph (f)(6) of this section and, if applicable, paragraphs (g) and (h) of this section, within a reasonable time after the MCO, PIHP, PAHP, or PCCM receives, from the State or its contracted representative, notice of the recipient's enrollment.
(4) The State, its contracted representative, or the MCO, PIHP, PAHP, or PCCM must give each enrollee written notice of any change (that the State defines as “significant”) in the information specified in paragraphs (f)(6) of this section and, if applicable, paragraphs (g) and (h) of this section, at least 30 days before the intended effective date of the change.
(5) The MCO, PIHP, and, when appropriate, the PAHP or PCCM, must make a good faith effort to give written notice of termination of a contracted provider, within 15 days after receipt or issuance of the termination notice, to each enrollee who received his or her primary care from, or was seen on a
(6) The State, its contracted representative, or the MCO, PIHP, PAHP, or PCCM must provide the following information to all enrollees:
(i) Names, locations, telephone numbers of, and non-English languages spoken by current contracted providers in the enrollee's service area, including identification of providers that are not accepting new patients. For MCOs, PIHPs, and PAHPs this includes, at a minimum, information on primary care physicians, specialists, and hospitals.
(ii) Any restrictions on the enrollee's freedom of choice among network providers.
(iii) Enrollee rights and protections, as specified in § 438.100.
(iv) Information on grievance and fair hearing procedures, and for MCO and PIHP enrollees, the information specified in § 438.10(g)(1), and for PAHP enrollees, the information specified in § 438.10(h)(1).
(v) The amount, duration, and scope of benefits available under the contract in sufficient detail to ensure that enrollees understand the benefits to which they are entitled.
(vi) Procedures for obtaining benefits, including authorization requirements.
(vii) The extent to which, and how, enrollees may obtain benefits, including family planning services, from out-of-network providers.
(viii) The extent to which, and how, after-hours and emergency coverage are provided, including:
(A) What constitutes emergency medical condition, emergency services, and poststabilization services, with reference to the definitions in § 438.114(a).
(B) The fact that prior authorization is not required for emergency services.
(C) The process and procedures for obtaining emergency services, including use of the 911-telephone system or its local equivalent.
(D) The locations of any emergency settings and other locations at which providers and hospitals furnish emergency services and poststabilization services covered under the contract.
(E) The fact that, subject to the provisions of this section, the enrollee has a right to use any hospital or other setting for emergency care.
(ix) The poststabilization care services rules set forth at § 422.113(c) of this chapter.
(x) Policy on referrals for specialty care and for other benefits not furnished by the enrollee's primary care provider.
(xi) Cost sharing, if any.
(xii) How and where to access any benefits that are available under the State plan but are not covered under the contract, including any cost sharing, and how transportation is provided. For a counseling or referral service that the MCO, PIHP, PAHP, or PCCM does not cover because of moral or religious objections, the MCO, PIHP, PAHP, or PCCM need not furnish information on how and where to obtain the service. The State must provide information on how and where to obtain the service.
(g)
(1) Grievance, appeal, and fair hearing procedures and timeframes, as provided in §§ 438.400 through 438.424, in a State-developed or State-approved description, that must include the following:
(i) For State fair hearing—
(A) The right to hearing;
(B) The method for obtaining a hearing; and
(C) The rules that govern representation at the hearing.
(ii) The right to file grievances and appeals.
(iii) The requirements and timeframes for filing a grievance or appeal.
(iv) The availability of assistance in the filing process.
(v) The toll-free numbers that the enrollee can use to file a grievance or an appeal by phone.
(vi) The fact that, when requested by the enrollee—
(A) Benefits will continue if the enrollee files an appeal or a request for State fair hearing within the timeframes specified for filing; and
(B) The enrollee may be required to pay the cost of services furnished while the appeal is pending, if the final decision is adverse to the enrollee.
(vii) Any appeal rights that the State chooses to make available to providers to challenge the failure of the organization to cover a service.
(2) Advance directives, as set forth in § 438.6(i)(2).
(3) Additional information that is available upon request, including the following:
(i) Information on the structure and operation of the MCO or PIHP.
(ii) Physician incentive plans as set forth in § 438.6(h) of this chapter.
(h)
(1) The right to a State fair hearing, including the following:
(i) The right to a hearing.
(ii) The method for obtaining a hearing.
(iii) The rules that govern representation.
(2) Advance directives, as set forth in § 438.6(i)(2), to the extent that the PAHP includes any of the providers listed in § 489.102(a) of this chapter.
(3) Upon request, physician incentive plans as set forth in § 438.6(h).
(i)
(2)
(i) For potential enrollees, within the timeframe specified in § 438.10(e)(1).
(ii) For enrollees, annually and upon request.
(iii) In a comparative, chart-like format.
(3)
(i) The MCO's or PCCM's service area.
(ii) The benefits covered under the contract.
(iii) Any cost sharing imposed by the MCO or PCCM.
(iv) To the extent available, quality and performance indicators, including enrollee satisfaction.
(a)
(2) In all contracts with health care professionals, an MCO, PIHP, or PAHP must comply with the requirements specified in § 438.214.
(b)
(1) Require the MCO, PIHP, or PAHP to contract with providers beyond the number necessary to meet the needs of its enrollees;
(2) Preclude the MCO, PIHP, or PAHP from using different reimbursement amounts for different specialties or for different practitioners in the same specialty; or
(3) Preclude the MCO, PIHP, or PAHP from establishing measures that are designed to maintain quality of services and control costs and are consistent with its responsibilities to enrollees.
(a)
(1) As part of a demonstration project under section 1115 of the Act; or
(2) Under a waiver granted under section 1915(b) of the Act.
(b)
(1) The types of entities with which the State contracts;
(2) The payment method it uses (for example, whether fee-for-service or capitation);
(3) Whether it contracts on a comprehensive risk basis; and
(4) The process the State uses to involve the public in both design and initial implementation of the program and the methods it uses to ensure ongoing public involvement once the State plan has been implemented.
(c)
(1) Section 1903(m) of the Act, for MCOs and MCO contracts.
(2) Section 1905(t) of the Act, for PCCMs and PCCM contracts.
(3) Section 1932(a)(1)(A) of the Act, for the State's option to limit freedom of choice by requiring recipients to receive their benefits through managed care entities.
(4) This part, for MCOs and PCCMs.
(5) Part 434 of this chapter, for all contracts.
(6) Section 438.6(c), for payments under any risk contracts, and § 447.362 of this chapter for payments under any nonrisk contracts.
(d)
(1) Recipients who are also eligible for Medicare.
(2) Indians who are members of Federally recognized tribes, except when the MCO or PCCM is—
(i) The Indian Health Service; or
(ii) An Indian health program or Urban Indian program operated by a tribe or tribal organization under a contract, grant, cooperative agreement or compact with the Indian Health Service.
(3) Children under 19 years of age who are—
(i) Eligible for SSI under title XVI;
(ii) Eligible under section 1902(e)(3) of the Act;
(iii) In foster care or other out-of-home placement;
(iv) Receiving foster care or adoption assistance; or
(v) Receiving services through a family-centered, community-based, coordinated care system that receives grant funds under section 501(a)(1)(D) of title V, and is defined by the State in terms of either program participation or special health care needs.
(e)
(f)
(2) The process must seek to preserve existing provider-recipient relationships and relationships with providers that have traditionally served Medicaid recipients. If that is not possible, the State must distribute the recipients equitably among qualified MCOs and PCCMs available to enroll them, excluding those that are subject to the intermediate sanction described in § 438.702(a)(4).
(3) An “existing provider-recipient relationship” is one in which the provider was the main source of Medicaid services for the recipient during the previous year. This may be established through State records of previous managed care enrollment or fee-for-service experience, or through contact with the recipient.
(4) A provider is considered to have “traditionally served” Medicaid recipients if it has experience in serving the Medicaid population.
(a)
(b)
(i) A program authorized by a plan amendment under section 1932(a) of the Act.
(ii) A waiver under section 1115 of the Act.
(iii) A waiver under section 1915(b) of the Act.
(2) A State that elects the option provided under paragraph (b)(1) of this section, must permit the recipient—
(i) To choose from at least two physicians or case managers; and
(ii) To obtain services from any other provider under any of the following circumstances:
(A) The service or type of provider (in terms of training, experience, and specialization) is not available within the MCO, PIHP, PAHP, or PCCM network.
(B) The provider is not part of the network, but is the main source of a service to the recipient, provided that—
(
(
(C) The only plan or provider available to the recipient does not, because of moral or religious objections, provide the service the enrollee seeks.
(D) The recipient's primary care provider or other provider determines that the recipient needs related services that would subject the recipient to unnecessary risk if received separately (for example, a cesarean section and a tubal ligation) and not all of the related services are available within the network.
(E) The State determines that other circumstances warrant out-of-network treatment.
(3) As used in this paragraph, “rural area” is any area other than an “urban area” as defined in § 412.62(f)(1)(ii) of this chapter.
(c)
(1) The HIO is one of those described in section 1932(a)(3)(C) of the Act; and
(2) The recipient who enrolls in the HIO has a choice of at least two primary care providers within the entity.
(d)
(a)
(b)
(2) Provide that the MCO, PIHP, PAHP, or PCCM may not request disenrollment because of an adverse change in the enrollee's health status, or because of the enrollee's utilization of medical services, diminished mental capacity, or uncooperative or disruptive behavior resulting from his or her special needs (except when his or her continued enrollment in the MCO, PIHP, PAHP, or PCCM seriously impairs the entity's ability to furnish
(3) Specify the methods by which the MCO, PIHP, PAHP, or PCCM assures the agency that it does not request disenrollment for reasons other than those permitted under the contract.
(c)
(1) For cause, at any time.
(2) Without cause, at the following times:
(i) During the 90 days following the date of the recipient's initial enrollment with the MCO, PIHP, PAHP, or PCCM, or the date the State sends the recipient notice of the enrollment, whichever is later.
(ii) At least once every 12 months thereafter.
(iii) Upon automatic reenrollment under paragraph (g) of this section, if the temporary loss of Medicaid eligibility has caused the recipient to miss the annual disenrollment opportunity.
(iv) When the State imposes the intermediate sanction specified in § 438.702(a)(3).
(d)
(i) To the State agency (or its agent); or
(ii) To the MCO, PIHP, PAHP, or PCCM, if the State permits MCOs, PIHP, PAHPs, and PCCMs to process disenrollment requests.
(2)
(i) The enrollee moves out of the MCO's, PIHP's, PAHP's, or PCCM's service area.
(ii) The plan does not, because of moral or religious objections, cover the service the enrollee seeks.
(iii) The enrollee needs related services (for example a cesarean section and a tubal ligation) to be performed at the same time; not all related services are available within the network; and the enrollee's primary care provider or another provider determines that receiving the services separately would subject the enrollee to unnecessary risk.
(iv) Other reasons, including but not limited to, poor quality of care, lack of access to services covered under the contract, or lack of access to providers experienced in dealing with the enrollee's health care needs.
(3)
(ii) If the MCO, PIHP, PAHP, PCCM, or State agency (whichever is responsible) fails to make a disenrollment determination so that the recipient can be disenrolled within the timeframes specified in paragraph (e)(1) of this section, the disenrollment is considered approved.
(4)
(i) Reasons cited in the request.
(ii) Information provided by the MCO, PIHP, PAHP, or PCCM at the agency's request.
(iii) Any of the reasons specified in paragraph (d)(2) of this section.
(5)
(ii) The grievance process, if used, must be completed in time to permit the disenrollment (if approved) to be effective in accordance with the timeframe specified in § 438.56(e)(1).
(iii) If, as a result of the grievance process, the MCO, PIHP, PAHP, or PCCM approves the disenrollment, the State agency is not required to make a determination.
(e)
(2) If the MCO, PIHP, PAHP, or PCCM or the State agency (whichever is responsible) fails to make the determination within the timeframes specified in paragraph (e)(1) of this section, the disenrollment is considered approved.
(f)
(1) Provide that enrollees and their representatives are given written notice of disenrollment rights at least 60 days before the start of each enrollment period.
(2) Ensure access to State fair hearing for any enrollee dissatisfied with a State agency determination that there is not good cause for disenrollment.
(g)
(a) As a condition for contracting with MCOs, PIHPs, or PAHPs, a State must have in effect safeguards against conflict of interest on the part of State and local officers and employees and agents of the State who have responsibilities relating to the MCO, PIHP, or PAHP contracts or the default enrollment process specified in § 438.50(f).
(b) These safeguards must be at least as effective as the safeguards specified in section 27 of the Office of Federal Procurement Policy Act (41 U.S.C. 423).
The State agency must ensure that no payment is made to a provider other than the MCO, PIHP, or PAHP for services available under the contract between the State and the MCO, PIHP, or PAHP, except when these payments are provided for in title XIX of the Act, in 42 CFR, or when the State agency has adjusted the capitation rates paid under the contract, in accordance with § 438.6(c)(5)(v), to make payments for graduate medical education.
The State agency must arrange for Medicaid services to be provided without delay to any Medicaid enrollee of an MCO, PIHP, PAHP, or PCCM whose contract is terminated and for any Medicaid enrollee who is disenrolled from an MCO, PIHP, PAHP, or PCCM for any reason other than ineligibility for Medicaid.
The State agency must have in effect procedures for monitoring the MCO's, PIHP's, or PAHP's operations, including, at a minimum, operations related to the following:
(a) Recipient enrollment and disenrollment.
(b) Processing of grievances and appeals.
(c) Violations subject to intermediate sanctions, as set forth in subpart I of this part.
(d) Violations of the conditions for FFP, as set forth in subpart J of this part.
(e) All other provisions of the contract, as appropriate.
(a)
(1) Each MCO and PIHP has written policies regarding the enrollee rights specified in this section; and
(2) Each MCO, PIHP, PAHP, and PCCM complies with any applicable Federal and State laws that pertain to enrollee rights, and ensures that its staff and affiliated providers take those rights into account when furnishing services to enrollees.
(b)
(2) An enrollee of an MCO, PIHP, PAHP, or PCCM has the following rights: The right to—
(i) Receive information in accordance with § 438.10.
(ii) Be treated with respect and with due consideration for his or her dignity and privacy.
(iii) Receive information on available treatment options and alternatives, presented in a manner appropriate to the enrollee's condition and ability to understand. (The information requirements for services that are not covered under the contract because of moral or religious objections are set forth in § 438.10(f)(6)(xii).)
(iv) Participate in decisions regarding his or her health care, including the right to refuse treatment.
(v) Be free from any form of restraint or seclusion used as a means of coercion, discipline, convenience or retaliation, as specified in other Federal regulations on the use of restraints and seclusion.
(vi) If the privacy rule, as set forth in 45 CFR parts 160 and 164 subparts A and E, applies, request and receive a copy of his or her medical records, and request that they be amended or corrected, as specified in 45 CFR § 164.524 and 164.526.
(3) An enrollee of an MCO, PIHP, or PAHP (consistent with the scope of the PAHP's contracted services) has the right to be furnished health care services in accordance with §§ 438.206 through 438.210.
(c)
(d)
(a)
(i) The enrollee's health status, medical care, or treatment options, including any alternative treatment that may be self-administered.
(ii) Any information the enrollee needs in order to decide among all relevant treatment options.
(iii) The risks, benefits, and consequences of treatment or nontreatment.
(iv) The enrollee's right to participate in decisions regarding his or her health care, including the right to refuse treatment, and to express preferences about future treatment decisions.
(2) Subject to the information requirements of paragraph (b) of this section, an MCO, PIHP, or PAHP that would otherwise be required to provide, reimburse for, or provide coverage of, a counseling or referral service because of the requirement in paragraph (a)(1) of this section is not required to do so if the MCO, PIHP, or PAHP objects to the service on moral or religious grounds.
(b)
(i) To the State—
(A) With its application for a Medicaid contract; and
(B) Whenever it adopts the policy during the term of the contract.
(ii) Consistent with the provisions of § 438.10—
(A) To potential enrollees, before and during enrollment; and
(B) To enrollees, within 90 days after adopting the policy with respect to any particular service. (Although this timeframe would be sufficient to entitle the MCO, PIHP, or PAHP to the option provided in paragraph (a)(2) of this section, the overriding rule in § 438.10(f)(4)
(2) As specified in § 438.10, paragraphs (e) and (f), the information that MCOs, PIHPs, and PAHPs must furnish to enrollees and potential enrollees does not include how and where to obtain the service excluded under paragraph (a)(2) of this section.
(c)
(d)
(a)
(1) Are produced in any medium, by or on behalf of an MCO, PIHP, PAHP, or PCCM; and
(2) Can reasonably be interpreted as intended to market to potential enrollees.
(b)
(1) Provide that the entity—
(i) Does not distribute any marketing materials without first obtaining State approval;
(ii) Distributes the materials to its entire service area as indicated in the contract;
(iii) Complies with the information requirements of § 438.10 to ensure that, before enrolling, the recipient receives, from the entity or the State, the accurate oral and written information he or she needs to make an informed decision on whether to enroll;
(iv) Does not seek to influence enrollment in conjunction with the sale or offering of any private insurance; and
(v) Does not, directly or indirectly, engage in door-to-door, telephone, or other cold-call marketing activities.
(2) Specify the methods by which the entity assures the State agency that marketing, including plans and materials, is accurate and does not mislead, confuse, or defraud the recipients or the State agency. Statements that will be considered inaccurate, false, or misleading include, but are not limited to, any assertion or statement (whether written or oral) that—
(i) The recipient must enroll in the MCO, PIHP, PAHP, or PCCM in order to obtain benefits or in order to not lose benefits; or
(ii) The MCO, PIHP, PAHP, or PCCM is endorsed by CMS, the Federal or State government, or similar entity.
(c)
Each MCO, PIHP, and PAHP must provide that its Medicaid enrollees are not held liable for any of the following:
(a) The MCO's, PIHP's, or PAHP's debts, in the event of the entity's insolvency.
(b) Covered services provided to the enrollee, for which—
(1) The State does not pay the MCO, PIHP, or PAHP; or
(2) The State, or the MCO, PIHP, or PAHP does not pay the individual or health care provider that furnishes the services under a contractual, referral, or other arrangement.
(c) Payments for covered services furnished under a contract, referral, or other arrangement, to the extent that those payments are in excess of the amount that the enrollee would owe if the MCO, PIHP, or PAHP provided the services directly.
The contract must provide that any cost sharing imposed on Medicaid enrollees is in accordance with §§ 447.50 through 447.60 of this chapter.
(a)
(1) Placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy.
(2) Serious impairment to bodily functions.
(3) Serious dysfunction of any bodily organ or part.
(1) Furnished by a provider that is qualified to furnish these services under this title.
(2) Needed to evaluate or stabilize an emergency medical condition.
(b)
(1) The MCO, PIHP, or PAHP.
(2) The PCCM that has a risk contract that covers these services.
(3) The State, in the case of a PCCM that has a fee-for-service contract.
(c)
(i) Must cover and pay for emergency services regardless of whether the provider that furnishes the services has a contract with the MCO, PIHP, PAHP, or PCCM; and
(ii) May not deny payment for treatment obtained under either of the following circumstances:
(A) An enrollee had an emergency medical condition, including cases in which the absence of immediate medical attention would not have had the outcomes specified in paragraphs (1), (2), and (3) of the definition of
(B) A representative of the MCO, PIHP, PAHP, or PCCM instructs the enrollee to seek emergency services.
(2) A PCCM must—
(i) Allow enrollees to obtain emergency services outside the primary care case management system regardless of whether the case manager referred the enrollee to the provider that furnishes the services; and
(ii) Pay for the services if the manager's contract is a risk contract that covers those services.
(d)
(i) Limit what constitutes an emergency medical condition with reference to paragraph (a) of this section, on the basis of lists of diagnoses or symptoms; and
(ii) Refuse to cover emergency services based on the emergency room provider, hospital, or fiscal agent not notifying the enrollee's primary care provider, MCO, PIHP, PAHP or applicable State entity of the enrollee's screening and treatment within 10 calendar days of presentation for emergency services.
(2) An enrollee who has an emergency medical condition may not be held liable for payment of subsequent screening and treatment needed to diagnose the specific condition or stabilize the patient.
(3) The attending emergency physician, or the provider actually treating the enrollee, is responsible for determining when the enrollee is sufficiently stabilized for transfer or discharge, and that determination is binding on the entities identified in paragraph (b) of this section as responsible for coverage and payment.
(e)
(f)
(a)
(2) Federally qualified HMOs, as defined in section 1310 of the Public Health Service Act, are exempt from this requirement.
(b)
(2)
(i) Does not provide both inpatient hospital services and physician services.
(ii) Is a public entity.
(iii) Is (or is controlled by) one or more Federally qualified health centers and meets the solvency standards established by the State for those centers.
(iv) Has its solvency guaranteed by the State.
This subpart implements section 1932(c)(1) of the Act and sets forth specifications for quality assessment and performance improvement strategies that States must implement to ensure the delivery of quality health care by all MCOs, PIHPs, and PAHPs. It also establishes standards that States, MCOs, PIHPs, and PAHPs must meet.
Each State contracting with an MCO or PIHP must do the following:
(a) Have a written strategy for assessing and improving the quality of managed care services offered by all MCOs and PIHPs.
(b) Obtain the input of recipients and other stakeholders in the development of the strategy and make the strategy available for public comment before adopting it in final.
(c) Ensure that MCOs, PIHPs, and PAHPs comply with standards established by the State, consistent with this subpart.
(d) Conduct periodic reviews to evaluate the effectiveness of the strategy, and update the strategy periodically, as needed.
(e) Submit to CMS the following:
(1) A copy of the initial strategy, and a copy of the revised strategy whenever significant changes are made.
(2) Regular reports on the implementation and effectiveness of the strategy.
At a minimum, State strategies must include the following:
(a) The MCO and PIHP contract provisions that incorporate the standards specified in this subpart.
(b) Procedures that—
(1) Assess the quality and appropriateness of care and services furnished to all Medicaid enrollees under the MCO and PIHP contracts, and to individuals with special health care needs.
(2) Identify the race, ethnicity, and primary language spoken of each Medicaid enrollee. States must provide this information to the MCO and PIHP for each Medicaid enrollee at the time of enrollment.
(3) Regularly monitor and evaluate the MCO and PIHP compliance with the standards.
(c) For MCOs and PIHPs, any national performance measures and levels that may be identified and developed by CMS in consultation with States and other relevant stakeholders.
(d) Arrangements for annual, external independent reviews of the quality outcomes and timeliness of, and access to, the services covered under each MCO and PIHP contract.
(e) For MCOs, appropriate use of intermediate sanctions that, at a minimum, meet the requirements of subpart I of this part.
(f) An information system that supports initial and ongoing operation and review of the State's quality strategy.
(g) Standards, at least as stringent as those in the following sections of this subpart, for access to care, structure and operations, and quality measurement and improvement.
(a)
(b)
(1) Maintains and monitors a network of appropriate providers that is supported by written agreements and is sufficient to provide adequate access to all services covered under the contract. In establishing and maintaining the network, each MCO, PIHP, and PAHP must consider the following:
(i) The anticipated Medicaid enrollment.
(ii) The expected utilization of services, taking into consideration the characteristics and health care needs of specific Medicaid populations represented in the particular MCO, PIHP, and PAHP.
(iii) The numbers and types (in terms of training, experience, and specialization) of providers required to furnish the contracted Medicaid services.
(iv) The numbers of network providers who are not accepting new Medicaid patients.
(v) The geographic location of providers and Medicaid enrollees, considering distance, travel time, the means of transportation ordinarily used by Medicaid enrollees, and whether the location provides physical access for Medicaid enrollees with disabilities.
(2) Provides female enrollees with direct access to a women's health specialist within the network for covered care necessary to provide women's routine and preventive health care services. This is in addition to the enrollee's designated source of primary care if that source is not a women's health specialist.
(3) Provides for a second opinion from a qualified health care professional within the network, or arranges for the enrollee to obtain one outside the network, at no cost to the enrollee.
(4) If the network is unable to provide necessary services, covered under the contract, to a particular enrollee, the MCO, PIHP, or PAHP must adequately and timely cover these services out of network for the enrollee, for as long as the MCO, PIHP, or PAHP is unable to provide them.
(5) Requires out-of-network providers to coordinate with the MCO or PIHP with respect to payment and ensures that cost to the enrollee is no greater than it would be if the services were furnished within the network.
(6) Demonstrates that its providers are credentialed as required by § 438.214.
(c)
(1)
(i) Meet and require its providers to meet State standards for timely access to care and services, taking into account the urgency of the need for services.
(ii) Ensure that the network providers offer hours of operation that are no less than the hours of operation offered to commercial enrollees or comparable to Medicaid fee-for-service, if the provider serves only Medicaid enrollees.
(iii) Make services included in the contract available 24 hours a day, 7 days a week, when medically necessary.
(iv) Establish mechanisms to ensure compliance by providers.
(v) Monitor providers regularly to determine compliance.
(vi) Take corrective action if there is a failure to comply.
(2)
(a)
(b)
(1) Offers an appropriate range of preventive, primary care, and specialty services that is adequate for the anticipated number of enrollees for the service area.
(2) Maintains a network of providers that is sufficient in number, mix, and geographic distribution to meet the needs of the anticipated number of enrollees in the service area.
(c)
(1) At the time it enters into a contract with the State.
(2) At any time there has been a significant change (as defined by the State) in the MCO's, PIHP's, or PAHP's operations that would affect adequate capacity and services, including—
(i) Changes in MCO, PIHP, or PAHP services, benefits, geographic service area or payments; or
(ii) Enrollment of a new population in the MCO, PIHP, or PAHP.
(d)
(e)
(a)
(2)
(i) Meet the primary care requirement of paragraph (b)(1) of this section; and
(ii) Implement mechanisms for identifying, assessing, and producing a treatment plan for an individual with special health care needs, as specified in paragraph (c) of this section.
(3)
(ii) The State bases its determination on the services it requires the MCO to furnish to dually eligible enrollees.
(b)
(1) Ensure that each enrollee has an ongoing source of primary care appropriate to his or her needs and a person or entity formally designated as primarily responsible for coordinating the health care services furnished to the enrollee.
(2) Coordinate the services the MCO, PIHP, or PAHP furnishes to the enrollee with the services the enrollee receives from any other MCO, PIHP, or PAHP.
(3) Share with other MCOs, PIHPs, and PAHPs serving the enrollee with special health care needs the results of its identification and assessment of that enrollee's needs to prevent duplication of those activities.
(4) Ensure that in the process of coordinating care, each enrollee's privacy is protected in accordance with the privacy requirements in 45 CFR parts 160 and 164 subparts A and E, to the extent that they are applicable.
(c)
(i) Must be specified in the State's quality improvement strategy in § 438.202; and
(ii) May use State staff, the State's enrollment broker, or the State's MCOs,
PIHPs and PAHPs.
(2)
(3)
(i) Developed by the enrollee's primary care provider with enrollee participation, and in consultation with any specialists caring for the enrollee;
(ii) Approved by the MCO, PIHP, or PAHP in a timely manner, if this approval is required by the MCO, PIHP, or PAHP; and
(iii) In accord with any applicable State quality assurance and utilization review standards.
(4)
(a)
(1) Identify, define, and specify the amount, duration, and scope of each service that the MCO, PIHP, or PAHP is required to offer.
(2) Require that the services identified in paragraph (a)(1) of this section be furnished in an amount, duration, and scope that is no less than the amount, duration, and scope for the same services furnished to beneficiaries under fee-for-service Medicaid, as set forth in § 440.230.
(3) Provide that the MCO, PIHP, or PAHP—
(i) Must ensure that the services are sufficient in amount, duration, or scope to reasonably be expected to achieve the purpose for which the services are furnished.
(ii) May not arbitrarily deny or reduce the amount, duration, or scope of a required service solely because of diagnosis, type of illness, or condition of the beneficiary;
(iii) May place appropriate limits on a service—
(A) On the basis of criteria applied under the State plan, such as medical necessity; or
(B) For the purpose of utilization control, provided the services furnished can reasonably be expected to achieve their purpose, as required in paragraph (a)(3)(i) of this section; and
(4) Specify what constitutes “medically necessary services” in a manner that—
(i) Is no more restrictive than that used in the State Medicaid program as indicated in State statutes and regulations, the State Plan, and other State policy and procedures; and
(ii) Addresses the extent to which the MCO, PIHP, or PAHP is responsible for covering services related to the following:
(A) The prevention, diagnosis, and treatment of health impairments.
(B) The ability to achieve age-appropriate growth and development.
(C) The ability to attain, maintain, or regain functional capacity.
(b)
(1) That the MCO, PIHP, or PAHP and its subcontractors have in place, and follow, written policies and procedures.
(2) That the MCO, PIHP, or PAHP—
(i) Have in effect mechanisms to ensure consistent application of review criteria for authorization decisions; and
(ii) Consult with the requesting provider when appropriate.
(3) That any decision to deny a service authorization request or to authorize a service in an amount, duration, or scope that is less than requested, be made by a health care professional who has appropriate clinical expertise in treating the enrollee's condition or disease.
(c)
(d)
(1)
(i) The enrollee, or the provider, requests extension; or
(ii) The MCO, PIHP, or PAHP justifies (to the State agency upon request) a need for additional information and how the extension is in the enrollee's interest.
(2)
(ii) The MCO, PIHP, or PAHP may extend the 3 working days time period by up to 14 calendar days if the enrollee requests an extension, or if the MCO, PIHP, or PAHP justifies (to the State agency upon request) a need for additional information and how the extension is in the enrollee's interest.
(e)
(a)
(b)
(2) Each MCO, PIHP, and PAHP must follow a documented process for credentialing and recredentialing of providers who have signed contracts or participation agreements with the MCO, PIHP, or PAHP.
(c)
(d)
(e)
The requirements that States must meet under § 438.10 constitute part of the State's quality strategy at § 438.204.
The State must ensure, through its contracts, that (consistent with subpart F of part 431 of this chapter), for medical records and any other health and enrollment information that identifies a particular enrollee, each MCO, PIHP, and PAHP uses and discloses such individually identifiable health information in accordance with the privacy requirements in 45 CFR parts 160 and 164, subparts A and E, to the extent that these requirements are applicable.
The State must ensure that each MCO, PIHP, and PAHP contract complies with the enrollment and disenrollment requirements and limitations set forth in § 438.56.
(a) The State must ensure, through its contracts, that each MCO and PIHP has in effect a grievance system that meets the requirements of subpart F of this part.
(b) If the State delegates to the MCO or PIHP responsibility for notice of action under subpart E of part 431 of this chapter, the State must conduct random reviews of each delegated MCO or PIHP and its providers and subcontractors to ensure that they are notifying enrollees in a timely manner.
(a)
(1) Oversees and is accountable for any functions and responsibilities that it delegates to any subcontractor; and
(2) Meets the conditions of paragraph (b) of this section.
(b)
(2) There is a written agreement that—
(i) Specifies the activities and report responsibilities delegated to the subcontractor; and
(ii) Provides for revoking delegation or imposing other sanctions if the subcontractor's performance is inadequate.
(3) The MCO, PIHP, or PAHP monitors the subcontractor's performance on an ongoing basis and subjects it to formal review according to a periodic schedule established by the State, consistent with industry standards or State MCO laws and regulations.
(4) If any MCO, PIHP, or PAHP identifies deficiencies or areas for improvement, the MCO, PIHP, or PAHP and the subcontractor take corrective action.
(a)
(b)
(1) Are based on valid and reliable clinical evidence or a consensus of health care professionals in the particular field.
(2) Consider the needs of the MCO's, PIHP's, or PAHP's enrollees.
(3) Are adopted in consultation with contracting health care professionals.
(4) Are reviewed and updated periodically as appropriate.
(c)
(d)
(a)
(2) CMS, in consultation with States and other stakeholders, may specify performance measures and topics for performance improvement projects to be required by States in their contracts with MCOs and PIHPs.
(b)
(1) Conduct performance improvement projects as described in paragraph (d) of this section. These projects must be designed to achieve, through ongoing measurements and intervention, significant improvement, sustained over time, in clinical care and nonclinical care areas that are expected to have a favorable effect on health outcomes and enrollee satisfaction.
(2) Submit performance measurement data as described in paragraph (c) of this section.
(3) Have in effect mechanisms to detect both underutilization and overutilization of services.
(4) Have in effect mechanisms to assess the quality and appropriateness of care furnished to enrollees with special health care needs.
(c)
(1) Measure and report to the State its performance, using standard measures required by the State including those that incorporate the requirements of § 438.204(c) and § 438.240(a)(2);
(2) Submit to the State, data specified by the State, that enables the State to measure the MCO's or PIHP's performance; or
(3) Perform a combination of the activities described in paragraphs (c)(1) and (c)(2) of this section.
(d)
(i) Measurement of performance using objective quality indicators.
(ii) Implementation of system interventions to achieve improvement in quality.
(iii) Evaluation of the effectiveness of the interventions.
(iv) Planning and initiation of activities for increasing or sustaining improvement.
(2) Each MCO and PIHP must report the status and results of each project to the State as requested, including those that incorporate the requirements of § 438.240(a)(2). Each performance improvement project must be completed in a reasonable time period so as to generally allow information on the success of performance improvement projects in the aggregate to produce new information on quality of care every year.
(e)
(i) The MCO's and PIHP's performance on the standard measures on which it is required to report; and
(ii) The results of each MCO's and PIHP's performance improvement projects.
(2) The State may require that an MCO or PIHP have in effect a process for its own evaluation of the impact and effectiveness of its quality assessment and performance improvement program.
(a)
(b)
(1) Collect data on enrollee and provider characteristics as specified by the State, and on services furnished to enrollees through an encounter data system or other methods as may be specified by the State.
(2) Ensure that data received from providers is accurate and complete by—
(i) Verifying the accuracy and timeliness of reported data;
(ii) Screening the data for completeness, logic, and consistency; and
(iii) Collecting service information in standardized formats to the extent feasible and appropriate.
(3) Make all collected data available to the State and upon request to CMS, as required in this subpart.
(a)
(b)
(1) Criteria that States must use in selecting entities to perform the reviews;
(2) Specifications for the activities related to external quality review;
(3) Circumstances under which external quality review may use the results of Medicare quality reviews or private accreditation reviews; and
(4) Standards for making available the results of the reviews.
(c)
As used in this subpart—
(1) A direct or indirect ownership or investment interest (including an option or nonvested interest) in any entity. This direct or indirect interest may be in the form of equity, debt, or other means and includes any indirect ownership or investment interest no matter how many levels removed from a direct interest; or
(2) A compensation arrangement with an entity.
Each State that contracts with MCOs or PIHPs must ensure that—
(a) Except as provided in § 438.362, a qualified EQRO performs an annual EQR for each contracting MCO or PIHP;
(b) The EQRO has sufficient information to use in performing the review;
(c) The information used to carry out the review must be obtained from the EQR-related activities described in § 438.358.
(d) For each EQR-related activity, the information must include the elements described in § 438.364(a)(1)(i) through (a)(1)(iv);
(e) The information provided to the EQRO in accordance with paragraph (c) of this section is obtained through methods consistent with the protocols established under § 438.352; and
(f) The results of the reviews are made available as specified in § 438.364.
Each protocol must specify—
(a) The data to be gathered;
(b) The sources of the data;
(c) The activities and steps to be followed in collecting the data to promote its accuracy, validity, and reliability;
(d) The proposed method or methods for validly analyzing and interpreting the data once obtained; and
(e) Instructions, guidelines, worksheets, and other documents or tools necessary for implementing the protocol.
(a)
(b)
(1) Staff with demonstrated experience and knowledge of—
(i) Medicaid recipients, policies, data systems, and processes;
(ii) Managed care delivery systems, organizations, and financing;
(iii) Quality assessment and improvement methods; and
(iv) Research design and methodology, including statistical analysis.
(2) Sufficient physical, technological, and financial resources to conduct EQR or EQR-related activities.
(3) Other clinical and nonclinical skills necessary to carry out EQR or EQR-related activities and to oversee the work of any subcontractors.
(c)
(1) A State agency, department, university, or other State entity may not have Medicaid purchasing or managed care licensing authority; and
(2) A State agency, department, university, or other State entity must be governed by a Board or similar body the majority of whose members are not government employees.
(3) An EQRO may not—
(i) Review a particular MCO or PIHP if either the EQRO or the MCO or PIHP exerts control over the other (as used in this paragraph, “control” has the meaning given the term in 48 CFR 19.101) through—
(A) Stock ownership;
(B) Stock options and convertible debentures;
(C) Voting trusts;
(D) Common management, including interlocking management; and
(E) Contractual relationships.
(ii) Deliver any health care services to Medicaid recipients;
(iii) Conduct, on the State's behalf, ongoing Medicaid managed care program operations related to oversight of the quality of MCO or PIHP services, except for the related activities specified in § 438.358; or
(iv) Have a present, or known future, direct or indirect financial relationship with an MCO or PIHP that it will review as an EQRO.
(a) The State—
(1) Must contract with one EQRO to conduct either EQR alone or EQR and other EQR-related activities; and
(2) May contract with additional EQROs to conduct EQR-related activities as set forth in § 438.358.
(b) Each EQRO must meet the competence requirements as specified in § 438.354(b).
(c) Each EQRO is permitted to use subcontractors. The EQRO is accountable for, and must oversee, all subcontractor functions.
(d) Each EQRO and its subcontractors performing EQR or EQR-related activities must meet the requirements for independence, as specified in § 438.354(c).
(e) For each contract, the State must follow an open, competitive procurement process that is in accordance with State law and regulations and consistent with 45 CFR part 74 as it applies to State procurement of Medicaid services.
(a)
(b)
(1) Validation of performance improvement projects required by the State to comply with requirements set forth in § 438.240(b)(1) and that were underway during the preceding 12 months.
(2) Validation of MCO or PIHP performance measures reported (as required by the State) or MCO or PIHP performance measure calculated by the State during the preceding 12 months to comply with requirements set forth in § 438.240(b)(2).
(3) A review, conducted within the previous 3-year period, to determine the MCO's or PIHP's compliance with standards (except with respect to standards under §§ 438.240(b)(1) and (2), for the conduct of performance improvement projects and calculation of performance measures respectively) established by the State to comply with the requirements of § 438.204(g).
(c)
(1) Validation of encounter data reported by an MCO or PIHP.
(2) Administration or validation of consumer or provider surveys of quality of care.
(3) Calculation of performance measures in addition to those reported by an MCO or PIHP and validated by an EQRO.
(4) Conduct of performance improvement projects in addition to those conducted by an MCO or PIHP and validated by an EQRO.
(5) Conduct of studies on quality that focus on a particular aspect of clinical or nonclinical services at a point in time.
(d)
(a)
(b)
(1) The MCO or PIHP is in compliance with standards established by CMS for Medicare+Choice or a national accrediting organization. The CMS or national accreditation standards are comparable to standards established by the State to comply with § 438.204(g) and the EQR-related activity under § 438.358(b)(3).
(2) Compliance with the standards is determined either by—
(i) CMS or its contractor for Medicare; or
(ii) A private national accrediting organization that CMS has approved as applying standards at least as stringent as Medicare under the procedures in § 422.158.
(3) The MCO or PIHP provides to the State all the reports, findings, and other results of the Medicare or private accreditation review applicable to the standards provided for in § 438.204(g); and the State provides the information to the EQRO.
(4) In its quality strategy, the State identifies the standards for which the EQR will use information from Medicare or private accreditation reviews, and explains its rationale for why the standards are duplicative.
(c)
(1) The MCO or PIHP serves only individuals who receive both Medicare and Medicaid benefits.
(2) The Medicare review activities are substantially comparable to the State-specified mandatory activities in § 438.358(b)(1) and (b)(2).
(3) The MCO or PIHP provides to the State all the reports, findings, and other results of the Medicare review from the activities specified under § 438.358(b)(1) and (b)(2) and the State provides the information to the EQRO.
(4) In its quality strategy, the State identifies the mandatory activities for which it has exercised this option and explains its rationale for why these activities are duplicative.
(a)
(1) The MCO or PIHP has a current Medicare contract under part C of title
(2) The two contracts cover all or part of the same geographic area within the State.
(3) The Medicaid contract has been in effect for at least 2 consecutive years before the effective date of the exemption and during those 2 years the MCO or PIHP has been subject to EQR under this part, and found to be performing acceptably with respect to the quality, timeliness, and access to health care services it provides to Medicaid recipients.
(b)
(1)
(i) All data, correspondence, information, and findings pertaining to the MCO's or PIHP's compliance with Medicare standards for access, quality assessment and performance improvement, health services, or delegation of these activities;
(ii) All measures of the MCO's or PIHP's performance; and
(iii) The findings and results of all performance improvement projects pertaining to Medicare enrollees.
(2)
(A) To fulfill certain requirements for Medicare external review under subpart D of part 422 of this chapter.
(B) To deem compliance with Medicare requirements, as provided in § 422.156 of this chapter.
(ii) These findings must include, but need not be limited to, accreditation review results of evaluation of compliance with individual accreditation standards, noted deficiencies, corrective action plans, and summaries of unmet accreditation requirements.
(a)
(1) A detailed technical report that describes the manner in which the data from all activities conducted in accordance with § 438.358 were aggregated and analyzed, and conclusions were drawn as to the quality, timeliness, and access to the care furnished by the MCO or PIHP. The report must also include the following for each activity conducted in accordance with § 438.358:
(i) Objectives.
(ii) Technical methods of data collection and analysis.
(iii) Description of data obtained.
(iv) Conclusions drawn from the data.
(2) An assessment of each MCO's or PIHP's strengths and weaknesses with respect to the quality, timeliness, and access to health care services furnished to Medicaid recipients.
(3) Recommendations for improving the quality of health care services furnished by each MCO or PIHP.
(4) As the State determines, methodologically appropriate, comparative information about all MCOs and PIHPs.
(5) An assessment of the degree to which each MCO or PIHP has addressed effectively the recommendations for quality improvement made by the EQRO during the previous year's EQR.
(b)
(c)
(a) FFP at the 75 percent rate is available in expenditures for EQR (including the production of EQR results) and EQR-related activities set forth in § 438.358 conducted by EQROs and their subcontractors.
(b) FFP at the 50 percent rate is available in expenditures for EQR-related activities conducted by any entity that does not qualify as an EQRO.
(a)
(1) Section 1902(a)(3) requires that a State plan provide an opportunity for a fair hearing to any person whose claim for assistance is denied or not acted upon promptly.
(2) Section 1902(a)(4) requires that the State plan provide for methods of administration that the Secretary finds necessary for the proper and efficient operation of the plan.
(3) Section 1932(b)(4) requires Medicaid managed care organizations to establish internal grievance procedures under which Medicaid enrollees, or providers acting on their behalf, may challenge the denial of coverage of, or payment for, medical assistance.
(b)
In the case of an MCO or PIHP—
(1) The denial or limited authorization of a requested service, including the type or level of service;
(2) The reduction, suspension, or termination of a previously authorized service;
(3) The denial, in whole or in part, of payment for a service;
(4) The failure to provide services in a timely manner, as defined by the State;
(5) The failure of an MCO or PIHP to act within the timeframes provided in § 438.408(b); or
(6) For a resident of a rural area with only one MCO, the denial of a Medicaid enrollee's request to exercise his or her right, under § 438.52(b)(2)(ii), to obtain services outside the network.
(a)
(b)
(ii) A provider, acting on behalf of the enrollee and with the enrollee's written consent, may file an appeal. A provider may file a grievance or request a State fair hearing on behalf of an enrollee, if the State permits the provider to act as the enrollee's authorized representative in doing so.
(2)
(i) The enrollee or the provider may file an appeal; and
(ii) In a State that does not require exhaustion of MCO and PIHP level appeals, the enrollee may request a State fair hearing.
(3)
(ii) The enrollee or the provider may file an appeal either orally or in writing, and unless he or she requests expedited resolution, must follow an oral filing with a written, signed, appeal.
(a)
(b)
(1) The action the MCO or PIHP or its contractor has taken or intends to take.
(2) The reasons for the action.
(3) The enrollee's or the provider's right to file an MCO or PIHP appeal.
(4) If the State does not require the enrollee to exhaust the MCO or PIHP level appeal procedures, the enrollee's right to request a State fair hearing.
(5) The procedures for exercising the rights specified in this paragraph.
(6) The circumstances under which expedited resolution is available and how to request it.
(7) The enrollee's right to have benefits continue pending resolution of the appeal, how to request that benefits be continued, and the circumstances under which the enrollee may be required to pay the costs of these services.
(c)
(1) For termination, suspension, or reduction of previously authorized Medicaid-covered services, within the timeframes specified in §§ 431.211, 431.213, and 431.214 of this chapter.
(2) For denial of payment, at the time of any action affecting the claim.
(3) For standard service authorization decisions that deny or limit services, within the timeframe specified in § 438.210(d)(1).
(4) If the MCO or PIHP extends the timeframe in accordance with § 438.210(d)(1), it must—
(i) Give the enrollee written notice of the reason for the decision to extend the timeframe and inform the enrollee of the right to file a grievance if he or she disagrees with that decision; and
(ii) Issue and carry out its determination as expeditiously as the enrollee's health condition requires and no later than the date the extension expires.
(5) For service authorization decisions not reached within the timeframes specified in § 438.210(d) (which constitutes a denial and is thus an adverse action), on the date that the timeframes expire.
(6) For expedited service authorization decisions, within the timeframes specified in § 438.210(d).
(a)
(1) Give enrollees any reasonable assistance in completing forms and taking other procedural steps. This includes, but is not limited to, providing interpreter services and toll-free numbers that have adequate TTY/TTD and interpreter capability.
(2) Acknowledge receipt of each grievance and appeal.
(3) Ensure that the individuals who make decisions on grievances and appeals are individuals—
(i) Who were not involved in any previous level of review or decision-making; and
(ii) Who, if deciding any of the following, are health care professionals who have the appropriate clinical expertise, as determined by the State, in treating the enrollee's condition or disease.
(A) An appeal of a denial that is based on lack of medical necessity.
(B) A grievance regarding denial of expedited resolution of an appeal.
(C) A grievance or appeal that involves clinical issues.
(b)
(1) Provide that oral inquiries seeking to appeal an action are treated as appeals (to establish the earliest possible filing date for the appeal) and must be confirmed in writing, unless the enrollee or the provider requests expedited resolution.
(2) Provide the enrollee a reasonable opportunity to present evidence, and allegations of fact or law, in person as
(3) Provide the enrollee and his or her representative opportunity, before and during the appeals process, to examine the enrollee's case file, including medical records, and any other documents and records considered during the appeals process.
(4) Include, as parties to the appeal—
(i) The enrollee and his or her representative; or
(ii) The legal representative of a deceased enrollee's estate.
(a)
(b)
(2)
(3)
(c)
(i) The enrollee requests the extension; or
(ii) The MCO or PIHP shows (to the satisfaction of the State agency, upon its request) that there is need for additional information and how the delay is in the enrollee's interest.
(2)
(d)
(2)
(ii) For notice of an expedited resolution, the MCO or PIHP must also make reasonable efforts to provide oral notice.
(e)
(1) The results of the resolution process and the date it was completed.
(2) For appeals not resolved wholly in favor of the enrollees—
(i) The right to request a State fair hearing, and how to do so;
(ii) The right to request to receive benefits while the hearing is pending, and how to make the request; and
(iii) That the enrollee may be held liable for the cost of those benefits if the hearing decision upholds the MCO's or PIHP's action.
(f)
(i) If the State requires exhaustion of the MCO or PIHP level appeal procedures, from the date of the MCO's or PIHP's notice of resolution; or
(ii) If the State does not require exhaustion of the MCO or PIHP level appeal procedures and the enrollee appeals directly to the State for a fair hearing, from the date on the MCO's or PIHP's notice of action.
(2)
(a)
(b)
(c)
(1) Transfer the appeal to the timeframe for standard resolution in accordance with § 438.408(b)(2);
(2) Make reasonable efforts to give the enrollee prompt oral notice of the denial, and follow up within two calendar days with a written notice.
The MCO or PIHP must provide the information specified at § 438.10(g)(1) about the grievance system to all providers and subcontractors at the time they enter into a contract.
The State must require MCOs and PIHPs to maintain records of grievances and appeals and must review the information as part of the State quality strategy.
(a)
(1) Within ten days of the MCO or PIHP mailing the notice of action.
(2) The intended effective date of the MCO's or PIHP's proposed action.
(b)
(1) The enrollee or the provider files the appeal timely;
(2) The appeal involves the termination, suspension, or reduction of a previously authorized course of treatment;
(3) The services were ordered by an authorized provider;
(4) The original period covered by the original authorization has not expired; and
(5) The enrollee requests extension of benefits.
(c)
(1) The enrollee withdraws the appeal.
(2) Ten days pass after the MCO or PIHP mails the notice, providing the resolution of the appeal against the enrollee, unless the enrollee, within the 10-day timeframe, has requested a State fair hearing with continuation of benefits until a State fair hearing decision is reached.
(3) A State fair hearing Office issues a hearing decision adverse to the enrollee.
(4) The time period or service limits of a previously authorized service has been met.
(d)
(a)
(b)
This subpart is based on sections 1902(a)(4), 1902(a)(19), 1903(m), and 1932(d)(1) of the Act.
(a) Section 1902(a)(4) requires that the State plan provide for methods of administration that the Secretary finds necessary for the proper and efficient operation of the plan.
(b) Section 1902(a)(19) requires that the State plan provide the safeguards necessary to ensure that eligibility is determined and services are provided in a manner consistent with simplicity of administration and the best interests of the recipients.
(c) Section 1903(m) establishes conditions for payments to the State with respect to contracts with MCOs.
(d) Section 1932(d)(1) prohibits MCOs and PCCMs from knowingly having certain types of relationships with individuals excluded under Federal regulations from participating in specified activities, or with affiliates of those individuals.
As a condition for receiving payment under the Medicaid managed care program, an MCO, PCCM, PIHP, or PAHP must comply with the applicable certification, program integrity and prohibited affiliation requirements of this subpart.
(a)
(b)
(a)
(1) The MCO's or PIHP's Chief Executive Officer.
(2) The MCO's or PIHP's Chief Financial Officer.
(3) An individual who has delegated authority to sign for, and who reports directly to, the MCO's or PIHP's Chief Executive Officer or Chief Financial Officer.
(b)
(1) To the accuracy, completeness and truthfulness of the data.
(2) To the accuracy, completeness and truthfulness of the documents specified by the State.
(c)
(a)
(b)
(1) Written policies, procedures, and standards of conduct that articulate
(2) The designation of a compliance officer and a compliance committee that are accountable to senior management.
(3) Effective training and education for the compliance officer and the organization's employees.
(4) Effective lines of communication between the compliance officer and the organization's employees.
(5) Enforcement of standards through well-publicized disciplinary guidelines.
(6) Provision for internal monitoring and auditing.
(7) Provision for prompt response to detected offenses, and for development of corrective action initiatives relating to the MCO's or PIHP's contract.
(a)
(1) An individual who is debarred, suspended, or otherwise excluded from participating in procurement activities under the Federal Acquisition Regulation or from participating in nonprocurement activities under regulations issued under Executive Order No. 12549 or under guidelines implementing Executive Order No. 12549.
(2) An individual who is an affiliate, as defined in the Federal Acquisition Regulation, of a person described in paragraph (a)(1) of this section.
(b)
(1) A director, officer, or partner of the MCO, PCCM, PIHP, or PAHP.
(2) A person with beneficial ownership of five percent or more of the MCO's, PCCM's, PIHP's, or PAHP's equity.
(3) A person with an employment, consulting or other arrangement with the MCO, PCCM, PIHP, or PAHP for the provision of items and services that are significant and material to the MCO's, PCCM's, PIHP's, or PAHP's obligations under its contract with the State.
(c)
(1) Must notify the Secretary of the noncompliance.
(2) May continue an existing agreement with the MCO, PCCM, PIHP, or PAHP unless the Secretary directs otherwise.
(3) May not renew or otherwise extend the duration of an existing agreement with the MCO, PCCM, PIHP, or PAHP unless the Secretary provides to the State and to Congress a written statement describing compelling reasons that exist for renewing or extending the agreement.
(d)
(a) Each State that contracts with an MCO must, and each State that contracts with a PCCM may, establish intermediate sanctions, as specified in § 438.702, that it may impose if it makes any of the determinations specified in paragraphs (b) through (d) of this section. The State may base its determinations on findings from onsite surveys, enrollee or other complaints, financial status, or any other source.
(b) A State determines whether an MCO acts or fails to act as follows:
(1) Fails substantially to provide medically necessary services that the MCO is required to provide, under law or under its contract with the State, to an enrollee covered under the contract.
(2) Imposes on enrollees premiums or charges that are in excess of the premiums or charges permitted under the Medicaid program.
(3) Acts to discriminate among enrollees on the basis of their health status or need for health care services. This includes termination of enrollment or refusal to reenroll a recipient, except as permitted under the Medicaid
(4) Misrepresents or falsifies information that it furnishes to CMS or to the State.
(5) Misrepresents or falsifies information that it furnishes to an enrollee, potential enrollee, or health care provider.
(6) Fails to comply with the requirements for physician incentive plans, as set forth (for Medicare) in §§ 422.208 and 422.210 of this chapter.
(c) A State determines whether an MCO, PIHP, PAHP or PCCM has distributed directly, or indirectly through any agent or independent contractor, marketing materials that have not been approved by the State or that contain false or materially misleading information.
(d) A State determines whether—
(1) An MCO has violated any of the other requirements of sections1903(m) or 1932 of the Act, and any implementing regulations;
(2) A PCCM has violated any of the other applicable requirements of sections 1932 or 1905(t)(3) of the Act and any implementing regulations;
(3) For any of the violations under paragraphs (d)(1) and (d)(2) of this section, only the sanctions specified in § 438.702, paragraphs (a)(3), (a)(4), and (a)(5) may be imposed.
(a) The types of intermediate sanctions that a State may impose under this subpart include the following:
(1) Civil money penalties in the amounts specified in § 438.704.
(2) Appointment of temporary management for an MCO as provided in § 438.706.
(3) Granting enrollees the right to terminate enrollment without cause and notifying the affected enrollees of their right to disenroll.
(4) Suspension of all new enrollment, including default enrollment, after the effective date of the sanction.
(5) Suspension of payment for recipients enrolled after the effective date of the sanction and until CMS or the State is satisfied that the reason for imposition of the sanction no longer exists and is not likely to recur.
(b) State agencies retain authority to impose additional sanctions under State statutes or State regulations that address areas of noncompliance specified in § 438.700, as well as additional areas of noncompliance. Nothing in this subpart prevents State agencies from exercising that authority.
(a)
(b)
(i) Paragraph (b)(1) (Failure to provide services).
(ii) Paragraph (b)(5) (Misrepresentation or false statements to enrollees, potential enrollees, or health care providers).
(iii) Paragraph (b)(6) (Failure to comply with physician incentive plan requirements).
(iv) Paragraph (c) (Marketing violations).
(2) The limit is $100,000 for each determination under paragraph (b)(3) (discrimination) or (b)(4) (Misrepresentation or false statements to CMS or the State) of § 438.700.
(3) The limit is $15,000 for each recipient the State determines was not enrolled because of a discriminatory practice under paragraph (b)(3) of § 438.700. (This is subject to the overall limit of $100,000 under paragraph (b)(2) of this section).
(c)
(a)
(1) There is continued egregious behavior by the MCO, including but not limited to behavior that is described in § 438.700, or that is contrary to any requirements of sections 1903(m) and 1932 of the Act; or
(2) There is substantial risk to enrollees' health; or
(3) The sanction is necessary to ensure the health of the MCO's enrollees—
(i) While improvements are made to remedy violations under § 438.700; or
(ii) Until there is an orderly termination or reorganization of the MCO.
(b)
(c)
(d)
A State has the authority to terminate an MCO or PCCM contract and enroll that entity's enrollees in other MCOs or PCCMs, or provide their Medicaid benefits through other options included in the State plan, if the State determines that the MCO or PCCM has failed to do either of the following:
(a) Carry out the substantive terms of its contract; or
(b) Meet applicable requirements in sections 1932, 1903(m), and 1905(t) of the Act.
(a)
(1) The basis and nature of the sanction.
(2) Any other due process protections that the State elects to provide.
(b)
(2)
(i) Give the MCO or PCCM written notice of its intent to terminate, the reason for termination, and the time and place of the hearing;
(ii) After the hearing, give the entity written notice of the decision affirming or reversing the proposed termination of the contract and, for an affirming decision, the effective date of termination; and
(iii) For an affirming decision, give enrollees of the MCO or PCCM notice of the termination and information, consistent with § 438.10, on their options for receiving Medicaid services following the effective date of termination.
After a State notifies an MCO or PCCM that it intends to terminate the contract, the State may do the following:
(a) Give the entity's enrollees written notice of the State's intent to terminate the contract.
(b) Allow enrollees to disenroll immediately without cause.
(a) The State must give the CMS Regional Office written notice whenever it imposes or lifts a sanction for one of the violations listed in § 438.700.
(b) The notice must—
(1) Be given no later than 30 days after the State imposes or lifts a sanction; and
(2) Specify the affected MCO, the kind of sanction, and the reason for the State's decision to impose or lift a sanction.
(a) The State plan must include a plan to monitor for violations that involve the actions and failures to act specified in this part and to implement the provisions of this part.
(b) A contract with an MCO must provide that payments provided for under the contract will be denied for new enrollees when, and for so long as, payment for those enrollees is denied by CMS under section 438.730(e).
(a)
(b)
(2) When the agency decides to recommend imposing the sanction described in paragraph (e) of this section, this recommendation becomes CMS's decision, for purposes of section 1903(m)(5)(B)(ii) of the Act, unless CMS rejects this recommendation within 15 days.
(c)
(1) Gives the MCO written notice of the nature and basis of the proposed sanction;
(2) Allows the MCO 15 days from the date it receives the notice to provide evidence that it has not acted or failed to act in the manner that is the basis for the recommended sanction;
(3) May extend the initial 15-day period for an additional 15 days if—
(i) the MCO submits a written request that includes a credible explanation of why it needs additional time;
(ii) the request is received by CMS before the end of the initial period; and
(iii) CMS has not determined that the MCO's conduct poses a threat to an enrollee's health or safety.
(d)
(i) Conducts an informal reconsideration that includes review of the evidence by a State agency official who did not participate in the original recommendation;
(ii) Gives the MCO a concise written decision setting forth the factual and legal basis for the decision; and
(iii) Forwards the decision to CMS.
(2) The agency decision under paragraph (d)(1)(ii) of this section becomes CMS's decision unless CMS reverses or modifies the decision within 15 days from date of receipt by CMS.
(3) If CMS reverses or modifies the State agency decision, the agency sends the MCO a copy of CMS's decision.
(e)
(i) If a CMS determination that an MCO has acted or failed to act, as described in paragraphs (b)(1) through (b)(6) of § 438.700, is affirmed on review under paragraph (d) of this section.
(ii) If the CMS determination is not timely contested by the MCO under paragraph (c) of this section.
(2) Under § 438.726(b), CMS's denial of payment for new enrollees automatically results in a denial of agency payments to the HMO for the same enrollees. (A new enrollee is an enrollee that applies for enrollment after the effective date in paragraph (f)(1) of this section.)
(f)
(2) If the MCO seeks reconsideration, the following rules apply:
(i) Except as specified in paragraph (d)(2)(ii) of this section, the sanction is effective on the date specified in CMS's reconsideration notice.
(ii) If CMS, in consultation with the State agency, determines that the MCO's conduct poses a serious threat to an enrollee's health or safety, the sanction may be made effective earlier than the date of the agency's reconsideration decision under paragraph (c)(1)(ii) of this section.
(g)
(2) At the same time that the agency sends notice to the MCO under paragraph (c)(1)(i) of this section, CMS forwards a copy of the notice to the OIG.
(3) CMS conveys the determination described in paragraph (b) of this section to the OIG for consideration of possible imposition of civil money penalties under section 1903(m)(5)(A) of the Act and part 1003 of this title. In accordance with the provisions of part 1003, the OIG may impose civil money penalties on the MCO in addition to, or in place of, the sanctions that may be imposed under this section.
FFP is available in expenditures for payments under an MCO contract only for the periods during which the contract—
(a) Meets the requirements of this part; and
(b) Is in effect.
(a)
(1) The Regional Office has confirmed that the contractor meets the definition of an MCO or is one of the entities described in paragraphs (b)(2) through (b)(5) of § 438.6; and
(2) The contract meets all the requirements of section 1903(m)(2)(A) of the Act, the applicable requirements of section 1932 of the Act, and the implementing regulations in this part.
(b)
(1) For 1998, the threshold is $1,000,000.
(2) For subsequent years, the amount is increased by the percentage increase in the consumer price index for all urban consumers.
(c) FFP is not available in an MCO contract that does not have prior approval from CMS under paragraph (b) of this section.
(a)
(b)
(2) An entity that has a substantial contractual relationship as defined in § 431.55(h)(3) of this chapter, either directly or indirectly, with an individual convicted of certain crimes as described in section 1128(b)(8)(B) of the Act.
(3) An entity that employs or contracts, directly or indirectly, for the furnishing of health care, utilization review, medical social work, or administrative services, with one of the following:
(i) Any individual or entity excluded from participation in Federal health care programs under either section 1128 or section 1128A of the Act.
(ii) Any entity that would provide those services through an excluded individual or entity.
(a)
(b)
(1)
(i) Is an MCO, PIHP, PAHP, PCCM or other health care provider in the State;
(ii) Is owned or controlled by an MCO, PIHP, PAHP, PCCM, or other health care provider in the State; or
(iii) Owns or controls an MCO, PIHP, PAHP, PCCM or other health care provider in the State.
(2)
(i) Has any direct or indirect financial interest in any entity or health care provider that furnishes services in the State in which the broker or subcontractor provides enrollment services;
(ii) Has been excluded from participation under title XVIII or XIX of the Act;
(iii) Has been debarred by any Federal agency; or
(iv) Has been, or is now, subject to civil money penalties under the Act.
(3)
(a) Under a risk contract, the total amount the State agency pays for carrying out the contract provisions is a medical assistance cost.
(b) Under a nonrisk contract—
(1) The amount the State agency pays for the furnishing of medical services to eligible recipients is a medical assistance cost; and
(2) The amount the State agency pays for the contractor's performance of other functions is an administrative cost.
Sec. 1102 of the Social Security Act (42 U.S.C. 1302).
This subpart interprets and implements the following sections of the Act:
1902(a)(70), State option to establish a non-emergency medical transportation program.
1905(a) Services included in the term “medical assistance.”
1905 (c), (d), (f) through (i), (l), and (m) Definitions of institutions and services that are included in the term “medical assistance.”
1913 “Swing-bed” services. (See §§ 447.280 and 482.66 of this chapter for related provisions on “swing-bed” services.)
1915(c) Home and community-based services listed as “medical assistance” and furnished under waivers under that section to individuals who would otherwise require the level of care furnished in a hospital, NF, or ICF/MR.
1915(d) Home and community-based services listed as “medical assistance” and furnished under waivers under that section to individuals age 65 or older who would otherwise require the level of care furnished in a NF.
(a)
(1) Receives room, board and professional services in the institution for a 24 hour period or longer, or
(2) Is expected by the institution to receive room, board and professional services in the institution for a 24 hour period or longer even though it later
(b)
(a)
(1) Are ordinarily furnished in a hospital for the care and treatment of inpatients;
(2) Are furnished under the direction of a physician or dentist; and
(3) Are furnished in an institution that—
(i) Is maintained primarily for the care and treatment of patients with disorders other than mental diseases;
(ii) Is licensed or formally approved as a hospital by an officially designated authority for State standard-setting;
(iii) Meets the requirements for participation in Medicare as a hospital; and
(iv) Has in effect a utilization review plan, applicable to all Medicaid patients, that meets the requirements of § 482.30 of this chapter, unless a waiver has been granted by the Secretary.
(b) Inpatient hospital services do not include SNF and ICF services furnished by a hospital with a swing-bed approval.
(a)
(1) Are furnished to outpatients;
(2) Are furnished by or under the direction of a physician or dentist; and
(3) Are furnished by an institution that—
(i) Is licensed or formally approved as a hospital by an officially designated authority for State standard-setting; and
(ii) Meets the requirements for participation in Medicare as a hospital; and
(4) May be limited by a Medicaid agency in the following manner: A Medicaid agency may exclude from the definition of “outpatient hospital services” those types of items and services that are not generally furnished by most hospitals in the State.
(b)
(1) Services furnished by a physician within the scope of practice of his profession under State law, if the physician performs the services in the clinic or the services are furnished away from the clinic and the physician has an agreement with the clinic providing that he will be paid by it for such services.
(2) Services furnished by a physician assistant, nurse practitioner, nurse midwife or other specialized nurse practitioner (as defined in §§ 405.2401 and 491.2 of this chapter) if the services are furnished in accordance with the
(3) Services and supplies that are furnished as an incident to professional services furnished by a physician, physician assistant, nurse practitioner, nurse midwife, or specialized nurse practitioner. (See §§ 405.2413 and 405.2415 of this chapter for the criteria for determining whether services and supplies are included under this paragraph.)
(4) Part-time or intermittent visiting nurse care and related medical supplies (other than drugs and biologicals) if:
(i) The clinic is located in an area in which the Secretary has determined that there is a shortage of home health agencies (see § 405.2417 of this chapter):
(ii) The services are furnished by a registered nurse or licensed practical nurse or a licensed vocational nurse employed by, or otherwise compensated for the services by, the clinic;
(iii) The services are furnished under a written plan of treatment that is established and reviewed at least every 60 days by a supervising physician of the clinic or that is established by a physician, physician assistant, nurse practitioner, nurse midwife, or specialized nurse practitioner and reviewed and approved at least every 60 days by a supervising physician of the clinic; and
(iv) The services are furnished to a homebound recipient. For purposes of visiting nurse care, a “homebound” recipient means one who is permanently or temporarily confined to his place of residence because of a medical or health condition. He may be considered homebound if he leaves the place of residence infrequently. For this purpose, “place of residence” does not include a hospital or a skilled nursing facility.
(c)
Other laboratory and X-ray services means professional and technical laboratory and radiological services—
(a) Ordered and provided by or under the direction of a physician or other licensed practioner of the healing arts within the scope of his practice as defined by State law or ordered by a physician but provided by referral laboratory;
(b) Provided in an office or similar facility other than a hospital outpatient department or clinic; and
(c) Furnished by a laboratory that meets the requirements of part 493 of this chapter.
(a)
(i) Needed on a daily basis and required to be provided on an inpatient basis under §§ 409.31 through 409.35 of this chapter.
(ii) Provided by—
(A) A facility or distinct part (as defined in § 483.5(b) of this chapter) that meets the requirements for participation under subpart B of part 483 of this chapter, as evidenced by a valid agreement between the Medicaid agency and the facility for providing nursing facility services and making payments for services under the plan; or
(B) If specified in the State plan, a swing-bed hospital that has an approval from CMS to furnish skilled nursing facility services in the Medicare program; and
(iii) Ordered by and provided under the direction of a physician.
(2) Nursing facility services include services provided by any facility located on an Indian reservation and certified by the Secretary as meeting the requirements of subpart B of part 483 of this chapter.
(b)
(1) Screening and diagnostic services to determine physical or mental defects in recipients under age 21; and
(2) Health care, treatment, and other measures to correct or ameliorate any defects and chronic conditions discovered. (See subpart B of part 441 of this chapter.)
(c)
(a) “Physicians' services,” whether furnished in the office, the recipient's home, a hospital, a skilled nursing facility, or elsewhere, means services furnished by a physician—
(1) Within the scope of practice of medicine or osteopathy as defined by State law; and
(2) By or under the personal supervision of an individual licensed under State law to practice medicine or osteopathy.
(b) “Medical and surgical services of a dentist” means medical and surgical services furnished, on or after January 1, 1988, by a doctor of dental medicine or dental surgery if the services are services that—
(1) If furnished by a physician, would be considered physician's services.
(2) Under the law of the State where they are furnished, may be furnished either by a physician or by a doctor of dental medicine or dental surgery; and
(3) Are furnished by a doctor of dental medicine or dental surgery who is authorized to furnish those services in the State in which he or she furnished the services.
(a) “Medical care or any other type remedial care provided by licensed practitioners” means any medical or remedial care or services, other than physicians' services, provided by licensed practitioners within the scope of practice as defined under State law.
(b) Chiropractors' services include only services that—
(1) Are provided by a chiropractor who is licensed by the State and meets standards issued by the Secretary under § 405.232(b) of this chapter; and
(2) Consists of treatment by means of manual manipulation of the spine that the chiropractor is legally authorized by the State to perform.
(a) “Home health services” means the services in paragraph (b) of this section that are provided to a recipient—
(1) At his place of residence, as specified in paragraph (c) of this section; and
(2) On his or her physician's orders as part of a written plan of care that the physician reviews every 60 days, except as specified in paragraph (b)(3) of this section.
(b) Home health services include the following services and items. Those listed in paragraphs (b) (1), (2) and (3) of this section are required services; those in paragraph (b)(4) of this section are optional.
(1) Nursing service, as defined in the State Nurse Practice Act, that is provided on a part-time or intermittent basis by a home health agency as defined in paragraph (d) of this section, or if there is no agency in the area, a registered nurse who—
(i) Is currently licensed to practice in the State;
(ii) Receives written orders from the patient's physician;
(iii) Documents the care and services provided; and
(iv) Has had orientation to acceptable clinical and administrative recordkeeping from a health department nurse.
(2) Home health aide service provided by a home health agency,
(3) Medical supplies, equipment, and appliances suitable for use in the home.
(i) A recipient's need for medical supplies, equipment, and appliances must be reviewed by a physician annually.
(ii) Frequency of further physician review of a recipient's continuing need for the items is determined on a case-by-case basis, based on the nature of the item prescribed;
(4) Physical therapy, occupational therapy, or speech pathology and audiology services, provided by a home health agency or by a facility licensed by the State to provide medical rehabilitation services. (See § 441.15 of this subchapter.)
(c) A recipient's place of residence, for home health services, does not include a hospital, nursing facility, or intermediate care facility for the mentally retarded, except for home health services in an intermediate care facility for the mentally retarded that are not required to be provided by the facility under subpart I of part 483. For example, a registered nurse may provide short-term care for a recipient in an intermediate care facility for the mentally retarded during an acute illness to avoid the recipient's transfer to a nursing facility.
(d) “Home health agency” means a public or private agency or organization, or part of an agency or organization, that meets requirements for participation in Medicare, including the capitalization requirements under § 489.28 of this chapter.
(e) A “facility licensed by the State to provide medical rehabilitation services” means a facility that—
(1) Provides therapy services for the primary purpose of assisting in the rehabilitation of disabled individuals through an integrated program of—
(i) Medical evaluation and services; and
(ii) Psychological, social, or vocational evaluation and services; and
(2) Is operated under competent medical supervision either—
(i) In connection with a hospital; or
(ii) As a facility in which all medical and related health services are prescribed by or under the direction of individuals licensed to practice medicine or surgery in the State.
(a) By a registered nurse or a licensed practical nurse;
(b) Under the direction of the recipient's physician; and
(c) To a recipient in one or more of the following locations at the option of the State—
(1) His or her own home;
(2) A hospital; or
(3) A skilled nursing facility.
(a) Services furnished at the clinic by or under the direction of a physician or dentist.
(b) Services furnished outside the clinic, by clinic personnel under the direction of a physician, to an eligible individual who does not reside in a permanent dwelling or does not have a fixed home or mailing address.
(a) “Dental services” means diagnostic, preventive, or corrective procedures provided by or under the supervision of a dentist in the practice of his profession, including treatment of—
(1) The teeth and associated structures of the oral cavity; and
(2) Disease, injury, or impairment that may affect the oral or general health of the recipient.
(b) “Dentist” means an individual licensed to practice dentistry or dental surgery.
(a)
(2) A “qualified physical therapist” is an individual who is—
(i) A graduate of a program of physical therapy approved by both the Committee on Allied Health Education and Accreditation of the American Medical Association and the American Physical Therapy Association or its equivalent; and
(ii) Where applicable, licensed by the State.
(b)
(2) A “qualified occupation therapist” is an individual who is—
(i) Registered by the American Occupational Therapy Association; or
(ii) A graduate of a program in occupational therapy approved by the Committee on Allied Health Education and Accreditation of the American Medical Association and engaged in the supplemental clinical experience required before registration by the American Occupational Therapy Association.
(c)
(2) A “speech pathologist” is an individual who meets one of the following conditions:
(i) Has a certificate of clinical competence from the American Speech and Hearing Association.
(ii) Has completed the equivalent educational requirements and work experience necessary for the certificate.
(iii) Has completed the academic program and is acquiring supervised work experience to qualify for the certificate.
(3) A “qualified audiologist” means an individual with a master's or doctoral degree in audiology that maintains documentation to demonstrate that he or she meets one of the following conditions:
(i) The State in which the individual furnishes audiology services meets or exceeds State licensure requirements in paragraph (c)(3)(ii)(A) or (c)(3)(ii)(B) of this section, and the individual is licensed by the State as an audiologist to furnish audiology services.
(ii) In the case of an individual who furnishes audiology services in a State that does not license audiologists, or an individual exempted from State licensure based on practice in a specific institution or setting, the individual must meet one of the following conditions:
(A) Have a Certificate of Clinical Competence in Audiology granted by the American Speech-Language-Hearing Association.
(B) Have successfully completed a minimum of 350 clock-hours of supervised clinical practicum (or is in the process of accumulating that supervised clinical experience under the supervision of a qualified master or doctoral-level audiologist); performed at least 9 months of full-time audiology services under the supervision of a qualified master or doctoral-level audiologist after obtaining a master's or doctoral degree in audiology, or a related field; and successfully completed
(a) “Prescribed drugs” means simple or compound substances or mixtures of substances prescribed for the cure, mitigation, or prevention of disease, or for health maintenance that are—
(1) Prescribed by a physician or other licensed practitioner of the healing arts within the scope of this professional practice as defined and limited by Federal and State law;
(2) Dispensed by licensed pharmacists and licensed authorized practitioners in accordance with the State Medical Practice Act; and
(3) Dispensed by the licensed pharmacist or practitioner on a written prescription that is recorded and maintained in the pharmacist's or practitioner's records.
(b) “Dentures” are artificial structures made by or under the direction of a dentist to replace a full or partial set of teeth.
(c) “Prosthetic devices” means replacement, corrective, or supportive devices prescribed by a physician or other licensed practitioner of the healing arts within the scope of his practice as defined by State law to—
(1) Artificially replace a missing portion of the body;
(2) Prevent or correct physical deformity or malfunction; or
(3) Support a weak or deformed portion of the body.
(d) “Eyeglasses” means lenses, including frames, and other aids to vision prescribed by a physician skilled in diseases of the eye or an optometrist.
(a) “Diagnostic services,” except as otherwise provided under this subpart, includes any medical procedures or supplies recommended by a physician or other licensed practitioner of the healing arts, within the scope of his practice under State law, to enable him to identify the existence, nature, or extent of illness, injury, or other health deviation in a recipient.
(b) “Screening services” means the use of standardized tests given under medical direction in the mass examination of a designated population to detect the existence of one or more particular diseases or health deviations or to identify for more definitive studies individuals suspected of having certain diseases.
(c) “Preventive services” means services provided by a physician or other licensed practitioner of the healing arts within the scope of his practice under State law to—
(1) Prevent disease, disability, and other health conditions or their progression;
(2) Prolong life; and
(3) Promote physical and mental health and efficiency.
(d) “Rehabilitative services,” except as otherwise provided under this subpart, includes any medical or remedial services recommended by a physician or other licensed practitioner of the healing arts, within the scope of his practice under State law, for maximum reduction of physical or mental disability and restoration of a recipient to his best possible functional level.
(a)
(1) Meets the requirements for utilization review in § 482.30(a), (b), (d), and (e) of this chapter; or
(2) Has been granted a waiver of those utilization review requirements under section 1903(i)(4) of the Act and subpart H of part 456 of this chapter.
(b)
(a) “ICF/MR services” means those items and services furnished in an intermediate care facility for the mentally retarded if the following conditions are met:
(1) The facility fully meets the requirements for a State license to provide services that are above the level of room and board;
(2) The primary purpose of the ICF/MR is to furnish health or rehabilitative services to persons with mental retardation or persons with related conditions;
(3) The ICF/MR meets the standards specified in subpart I of part 483 of this chapter.
(4) The recipient with mental retardation for whom payment is requested is receiving active treatment, as specified in § 483.440 of this chapter.
(5) The ICF/MR has been certified to meet the requirements of subpart C of part 442 of this chapter, as evidenced by a valid agreement between the Medicaid agency and the facility for furnishing ICF/MR services and making payments for these services under the plan.
(b) ICF/MR services may be furnished in a distinct part of a facility other than an ICF/MR if the distinct part—
(1) Meets all requirements for an ICF/MR, as specified in subpart I of part 483 of this chapter;
(2) Is clearly an identifiable living unit, such as an entire ward, wing, floor or building;
(3) Consists of all beds and related services in the unit;
(4) Houses all recipients for whom payment is being made for ICF/MR services; and
(5) Is approved in writing by the survey agency.
(a) “Nursing facility services, other than in an institution for mental diseases” means services provided in a facility that—
(1) Fully meets the requirements for a State license to provide, on a regular basis, health-related services to individuals who do not require hospital care, but whose mental or physical condition requires services that—
(i) Are above the level of room and board; and
(ii) Can be made available only through institutional facilities;
(2) Has been certified to meet the requirements of subpart C of part 442 of this chapter as evidenced by a valid agreement between the Medicaid agency and the facility for providing nursing facility services and making payments for services under the plan; and
(b) “Nursing facility services” include services—
(1) Considered appropriate by the State and provided by a religious nonmedical institution as defined in § 440.170(b); or
(2) Provided by a facility located on an Indian reservation that—
(i) Furnishes, on a regular basis, health-related services; and
(ii) Is certified by the Secretary to meet the standards in subpart E of part 442 of this chapter.
(c) “Nursing facility services” may include services provided in a distinct part (as defined in § 483.5(b) of this chapter) of a facility other than a nursing facility if the distinct part (as defined in § 483.5(b) of this chapter)—
(1) Meets all requirements for a nursing facility;
(2) Is an identifiable unit, such as an entire ward or contiguous ward, a wing, floor, or building;
(3) Consists of all beds and related facilities in the unit;
(4) Houses all recipients for whom payment is being made for nursing facility services, except as provided in paragraph (d) of this section;
(5) Is clearly identified; and
(6) Is approved in writing by the survey agency.
(d) If a State includes as nursing facility services those services provided
(e) Nursing facility services may include services provided in a swing-bed hospital that has an approval to furnish nursing facility services.
“Inpatient psychiatric services for individuals under age 21” means services that—
(a) Are provided under the direction of a physician;
(b) Are provided by—
(1) A psychiatric hospital or an inpatient psychiatric program in a hospital, accredited by the Joint Commission on Accreditation of Healthcare Organizations, or
(2) A psychiatric facility which is accredited by the Joint Commission on Accreditation of Healthcare Organizations, the Council on Accreditation of Services for Families and Children, the Commission on Accreditation of Rehabilitation Facilities, or by any other accrediting organization, with comparable standards, that is recognized by the State.
(c) Meet the requirements in § 441.151 of this subchapter.
(a) “Nurse-midwife services” means services that—
(1) Are furnished by a nurse-midwife within the scope of practice authorized by State law or regulation and, in the case of inpatient or outpatient hospital services or clinic services, are furnished by or under the direction of a nurse-midwife to the extent permitted by the facility; and
(2) Unless required by State law or regulations or a facility, are reimbursed without regard to whether the nurse-midwife is under the supervision of, or associated with, a physician or other health care provider. (See § 441.21 of this chapter for provisions on independent provider agreements for nurse-midwives.)
(b) “Nurse-midwife” means a registered professional nurse who meets the following requirements:
(1) Is currently licensed to practice in the State as a registered professional nurse.
(2) Is legally authorized under State law or regulations to practice as a nurse-midwife.
(3) Except as provided in paragraph (b)(4) of this section, has completed a program of study and clinical experience for nurse-midwives, as specified by the State.
(4) If the State does not specify a program of study and clinical experience that nurse-midwives must complete to practice in that State, meets one of the following conditions:
(i) Is currently certified as a nurse-midwife by the American College of Nurse-Midwives (ACNM or by the ACNM Certification Council, Inc. (ACC).
(ii) Has satisfactorily completed a formal education program (of at least one academic year) that, upon completion qualifies the nurse to take the certification examination offered by the American College of Nurse-Midwives (ACNM) or by the ACNM Certification Council, Inc. (ACC).
(iii) Has successfully completed a formal educational program for preparing registered nurses to furnish gynecological and obstetrical care to women during pregnancy, delivery, and the postpartum period, and care to normal newborns, and was practicing as a nurse-midwife for a total of 12 months during any 18-month period from August 8, 1976 to July 16, 1982.
(a)
(b)
(1) If the State specifies qualifications for pediatric nurse practitioners, the practitioner must—
(i) Be currently licensed to practice in the State as a registered professional nurse; and
(ii) Meet the State requirements for qualification of pediatric nurse practitioners in the State in which he or she furnishes the services.
(2) If the State does not specify, by specialty, qualifications for pediatric nurse practitioners, but the State does define qualifications for nurses in advanced practice or general nurse practitioners, the practitioner must—
(i) Meet qualifications for nurses in advanced practice or general nurse practitioners as defined by the State; and
(ii) Have a pediatric nurse practice limited to providing primary health care to persons less than 21 years of age.
(c)
(1) If the State specifies qualifications for family nurse practitioners, the practitioner must—
(i) Be currently licensed to practice in the State as a registered professional nurse; and
(ii) Meet the State requirements for qualification of family nurse practitioners in the State in which he or she furnishes the services.
(2) If the State does not specify, by specialty, qualifications for family nurse practitioners, but the State does define qualifications for nurses in advanced practice or general nurse practitioners, the practitioner must—
(i) Meet qualifications for nurses in advanced practice or general nurse practitioners as defined by the State; and
(ii) Have a family nurse practice limited to providing primary health care to individuals and families.
(d)
Unless defined differently by a State agency for purposes of a waiver granted under part 441, subpart G of this chapter—
(a)
(1) Authorized for the individual by a physician in accordance with a plan of treatment or (at the option of the State) otherwise authorized for the individual in accordance with a service plan approved by the State;
(2) Provided by an individual who is qualified to provide such services and who is not a member of the individual's family; and
(3) Furnished in a home, and at the State's option, in another location.
(b) For purposes of this section,
(a) Primary care case management services means case management related services that—
(1) Include location, coordination, and monitoring of primary health care services; and
(2) Are provided under a contract between the State and either of the following:
(i) A PCCM who is a physician or may, at State option, be a physician assistant, nurse practitioner, or certified nurse-midwife.
(ii) A physician group practice, or an entity that employs or arranges with physicians to furnish the services.
(b) Primary care case management services may be offered by the State—
(1) As a voluntary option under the State plan; or
(2) On a mandatory basis under section 1932 (a)(1) of the Act or under section 1915(b) or section 1115 waiver authority.
(a)
(b) T
(c) [Reserved]
(d) The assistance that case managers provide in assisting eligible individuals obtain services includes—
(1) Comprehensive assessment and periodic reassessment of individual needs, to determine the need for any medical, educational, social, or other services. These assessment activities include the following:
(i) Taking client history.
(ii) Identifying the needs of the individual, and completing related documentation.
(iii) Gathering information from other sources, such as family members, medical providers, social workers, and educators (if necessary) to form a complete assessment of the eligible individual.
(2) Development (and periodic revision) of a specific care plan based on the information collected through the assessment, that includes the following:
(i) Specifies the goals and actions to address the medical, social, educational, and other services needed by the eligible individual.
(ii) Includes activities such as ensuring the active participation of the eligible individual and working with the individual (or the individual's authorized health care decision maker) and others to develop those goals.
(iii) Identifies a course of action to respond to the assessed needs of the eligible individual.
(3) Referral and related activities (such as scheduling appointments for the individual) to help the eligible individual obtain needed services, including activities that help link the individual with medical, social, and educational providers or other programs and services that are capable of providing needed services to address identified needs and achieve goals specified in the care plan.
(4) Monitoring and follow-up activities, including activities and contacts that are necessary to ensure that the care plan is effectively implemented and adequately addresses the needs of the eligible individual and which may be with the individual, family members, service providers, or other entities or individuals and conducted as frequently as necessary, and including at least one annual monitoring, to help determine whether the following conditions are met:
(i) Services are being furnished in accordance with the individual's care plan.
(ii) Services in the care plan are adequate.
(iii) There are changes in the needs or status of the eligible individual. Monitoring and follow-up activities include making necessary adjustments in the care plan and service arrangements with providers.
(e) Case management may include contacts with non-eligible individuals that are directly related to the identification of the eligible individual's needs and care, for the purposes of helping the eligible individual access services, identifying needs and supports to assist the eligible individual in obtaining services, providing case managers with useful feedback, and alerting case managers to changes in the eligible individual's needs.
(a)
(2) Except as provided in paragraph (a)(4), transportation, as defined in this section, is furnished only by a provider to whom a direct vendor payment can appropriately be made by the agency.
(3) “Travel expenses” include—
(i) The cost of transportation for the recipient by ambulance, taxicab, common carrier, or other appropriate means;
(ii) The cost of meals and lodging en route to and from medical care, and while receiving medical care; and
(iii) The cost of an attendant to accompany the recipient, if necessary, and the cost of the attendant's transportation, meals, lodging, and, if the attendant is not a member of the recipient's family, salary.
(4) Non-emergency medical transportation brokerage program. At the option of the State, and notwithstanding § 431.50 (statewide operation) and § 431.51 (freedom of choice of providers) of this chapter and § 440.240 (comparability of services for groups), a State plan may provide for the establishment of a non-emergency medical transportation brokerage program in order to more cost-effectively provide non-emergency medical transportation services for individuals eligible for medical assistance under the State plan who need access to medical care or services, and have no other means of transportation. These transportation services include wheelchair vans, taxis, stretcher cars, bus passes and tickets, secured transportation containing an occupant protection system that addresses safety needs of disabled or special needs individuals, and other forms of transportation otherwise covered under the state plan.
(i) Non-emergency medical transportation services may be provided under contract with individuals or entities that meet the following requirements:
(A) Is selected through a competitive bidding process that is consistent with 45 CFR 92.36(b) through (i) and is based on the State's evaluation of the broker's experience, performance, references, resources, qualifications, and costs.
(B) Has oversight procedures to monitor beneficiary access and complaints and ensure that transportation is timely and that transport personnel are licensed, qualified, competent, and courteous.
(C) Is subject to regular auditing and oversight by the State in order to ensure the quality and timeliness of the transportation services provided and the adequacy of beneficiary access to medical care and services.
(D) Is subject to a written contract that imposes the requirements related to prohibitions on referrals and conflicts of interest described at § 440.170(a)(4)(ii), and provides for the broker to be liable for the full cost of services resulting from a prohibited referral or subcontract.
(ii) Federal financial participation is available at the medical assistance rate for the cost of a written brokerage contract that:
(A) Except as provided in paragraph (a)(4)(ii)(B) of this section, prohibits the broker (including contractors, owners, investors, Boards of Directors, corporate officers, and employees) from providing non-emergency medical transportation services or making a referral or subcontracting to a transportation service provider if:
(
(
(B) Exceptions: The prohibitions described at clause (A) of this paragraph do not apply if there is documentation to support the following:
(
(
(
(
(
(
(
(C) Transportation providers may not offer or make any payment or other form of remuneration, including any kickback, rebate, cash, gifts, or service in kind to the broker in order to influence referrals or subcontracting for non-emergency medical transportation provided to a Medicaid recipient.
(D) In referring or subcontracting for non-emergency medical transportation with transportation providers, a broker may not withhold necessary non-emergency medical transportation from a Medicaid recipient or provide non-emergency medical transportation that is not the most appropriate and a cost-effective means of transportation for that recipient for the purpose of financial gain, or for any other purpose.
(b)
(1) Is an institution that is described in (c)(3) of section 501 of the Internal Revenue Code of 1986 and is exempt from taxes under section 501(a) of that section.
(2) Is lawfully operated under all applicable Federal, State, and local laws and regulations.
(3) Furnishes only nonmedical nursing items and services to patients who choose to rely solely upon a religious method of healing and for whom the acceptance of medical health services would be inconsistent with their religious beliefs.
(4) Furnishes nonmedical items and services exclusively through nonmedical nursing personnel who are experienced in caring for the physical needs of nonmedical patients.
(5) Furnishes these nonmedical items and services to inpatients on a 24-hour basis.
(6) Does not furnish, on the basis of its religious beliefs, through its personnel or otherwise, medical items and services (including any medical screening, examination, diagnosis, prognosis, treatment, or the administration of drugs) for its patients.
(7) Is not owned by, is not under common ownership with, or does not have an ownership interest of 5 percent or more in, a provider of medical treatment or services and is not affiliated with a provider of medical treatment or services or with an individual who has an ownership interest or 5 percent or more in a provider of medical treatment or services. Permissible affiliations are described in paragraph (c) of this section.
(8) Has in effect a utilization review plan that meets the following criteria:
(i) Provides for the review of admissions to the institution, duration of stays, cases of continuous extended duration, and items and services furnished by the institution.
(ii) Requires that the reviews be made by a committee of the institution that included the individuals responsible for overall administration and for supervision of nursing personnel at the institution.
(iii) Provides that records be maintained of the meetings, decisions, and actions of the utilization review committee.
(iv) Meets other requirements as CMS finds necessary to establish an effective utilization review plan.
(9) Provides information CMS may require to implement section 1821 of the Act, including information relating to quality of care and coverage determinations.
(10) Meets other requirements as CMS finds necessary in the interest of the health and safety of patients who receive services in the institution. These requirements are the conditions of participation found at part 403, subpart G of this chapter.
(c)
(1) An individual serving as an uncompensated director, trustee, officer, or other member of the governing body of an RNHCI and a provider of medical treatment or services.
(2) An individual who is a director, trustee, officer, employee, or staff member of an RNHCI and an another individual, with whom he or she has a family relationship, who is affiliated with (or has an ownership interest in) a provider of medical treatment or services.
(3) The RNHCI and an individual or entity furnishing goods or services as a vendor to both providers of medical treatment or services and RNHCIs.
(d)
(e)
(1) Are necessary to prevent the death or serious impairment of the health of a recipient; and
(2) Because of the threat to the life or health of the recipient necessitate the use of the most accessible hospital available that is equipped to furnish the services, even if the hospital does not currently meet—
(i) The conditions for participation under Medicare; or
(ii) The definitions of inpatient or outpatient hospital services under §§ 440.10 and 440.20.
(f) [Reserved]
(g)
(2) Inpatient CAH services do not include nursing facility services furnished by a CAH with a swing-bed approval.
(a)
(1) These services may consist of any or all of the services listed in paragraph (b) of this section, as those services are defined by the agency and approved by CMS.
(2) The services must meet the standards specified in § 441.302(a) of this chapter concerning health and welfare assurances.
(3) The services are subject to the limits on FFP described in § 441.310 of this chapter.
(b)
(1) Case management services.
(2) Homemaker services.
(3) Home health aide services.
(4) Personal care services.
(5) Adult day health services.
(6) Habilitation services.
(7) Respite care services.
(8) Day treatment or other partial hospitalization services, psychosocial rehabilitation services and clinic services (whether or not furnished in a facility) for individuals with chronic mental illness, subject to the conditions specified in paragraph (d) of this section.
(9) Other services requested by the agency and approved by CMS as cost effective and necessary to avoid institutionalization.
(c)
(2)
(i) Prevocational services, which means services that prepare an individual for paid or unpaid employment and that are not job-task oriented but are, instead, aimed at a generalized result. These services may include, for example, teaching an individual such concepts as compliance, attendance, task completion, problem solving and safety. Prevocational services are distinguishable from noncovered vocational services by the following criteria:
(A) The services are provided to persons who are not expected to be able to join the general work force or participate in a transitional sheltered workshop within one year (excluding supported employment programs).
(B) If the recipients are compensated, they are compensated at less than 50 percent of the minimum wage;
(C) The services include activities which are not primarily directed at teaching specific job skills but at underlying habilitative goals (for example, attention span, motor skills); and
(D) The services are reflected in a plan of care directed to habilitative rather than explicit employment objectives.
(ii) Educational services, which means special education and related services (as defined in sections 602(16) and (17) of the Education of the Handicapped Act) (20 U.S.C. 1401 (16 and 17)) to the extent they are not prohibited under paragraph (c)(3)(i) of this section.
(iii) Supported employment services, which facilitate paid employment, that are—
(A) Provided to persons for whom competitive employment at or above the minimum wage is unlikely and who, because of their disabilities, need intensive ongoing support to perform in a work setting;
(B) Conducted in a variety of settings, particularly worksites in which persons without disabilities are employed; and
(C) Defined as any combination of special supervisory services, training, transportation, and adaptive equipment that the State demonstrates are essential for persons to engage in paid employment and that are not normally required for nondisabled persons engaged in competitive employment.
(3)
(i) Special education and related services (as defined in sections 602(16) and (17) of the Education of the Handicapped Act) (20 U.S.C. 1401 (16) and (17)) that are otherwise available to the individual through a local educational agency.
(ii) Vocational rehabilitation services that are otherwise available to the individual through a program funded under section 110 of the Rehabilitation Act of 1973 (29 U.S.C. 730).
(d)
(2)
(i) For individuals aged 22 through 64 who, absent the waiver, would be institutionalized in an institution for mental diseases (IMD); and, therefore, subject to the limitation on IMDs specified in § 435.1009(a)(2) of this chapter.
(ii) For individuals, not meeting the age requirements described in paragraph (d)(2)(i) of this section, who, absent the waiver, would be placed in an IMD in those States that have not opted to include the benefits defined in § 440.140 or § 440.160.
(a)
(b)
(2) Homemaker services.
(3) Home health aide services.
(4) Personal care services.
(5) Adult day health services.
(6) Respite care services.
(7) Other medical and social services requested by the Medicaid agency and approved by CMS, which will contribute to the health and well-being of individuals and their ability to reside in a community-based care setting.
(a) “Respiratory care for ventilator-dependent individuals” means services that are not otherwise available under the State's Medicaid plan, provided on a part-time basis in the recipient's home by a respiratory therapist or other health care professional trained in respiratory therapy (as determined by the State) to an individual who—
(1) Is medically dependent on a ventilator for life support at least 6 hours per day;
(2) Has been so dependent for at least 30 consecutive days (or the maximum number of days authorized under the State plan, whichever is less) as an inpatient in one or more hospitals, NFs, or ICFs/MR;
(3) Except for the availability of respiratory care services, would require respiratory care as an inpatient in a hospital, NF, or ICF/MR and would be eligible to have payment made for inpatient care under the State plan;
(4) Has adequate social support services to be cared for at home;
(5) Wishes to be cared for at home; and
(6) Receives services under the direction of a physician who is familiar with the technical and medical components of home ventilator support, and who has medically determined that in-home care is safe and feasible for the individual.
(b) For purposes of paragraphs (a)(4) and (5) of this section, a recipient's home does not include a hospital, NF, ICF/MR or other institution as defined in § 435.1010 of this chapter.
(a) This subpart implements the following statutory requirements—
(1) Section 1902(a)(10), regarding comparability of services for groups of recipients, and the amount, duration, and scope of services described in section 1905(a) of the Act that the State plan must provide for recipients;
(2) Section 1902(a)(22)(D), which provides for standards and methods to assure quality of services;
(3) Section 1903(v)(1), which provides that no payment may be made to a State under this section for medical assistance furnished to an alien who is not lawfully admitted for permanent residence or otherwise permanently residing in the United States under color of law;
(4) Section 1903(v)(2) which provides that FFP will be available for services necessary to treat an emergency medical condition of an alien not described in paragraph (a)(3) of this section if that alien otherwise meets the eligibility requirements of the State plan;
(5) Section 1907 on observance of religious beliefs;
(6) Section 1915 on exceptions to section 1902(a)(10) and waivers of other requirements of section 1902 of the Act; and
(7) Sections 245A(h), 210 and 210A of the Immigration and Nationality Act which provide that certain aliens who are legalized may be eligible for Medicaid.
(b) The requirements and limits of this subpart apply for all services defined in subpart A of this part.
(a) A State plan must specify that, at a minimum, categorically needy recipients are furnished the following services:
(1) The services defined in §§ 440.10 through 440.50, 440.70, and (to the extent nurse-midwives and nurse practitioners are authorized to practice under State law or regulation) the services defined in §§ 440.165 and 440.166, respectively.
(2) Pregnancy-related services and services for other conditions that might complicate the pregnancy.
(i) Pregnancy-related services are those services that are necessary for the health of the pregnant woman and fetus, or that have become necessary as a result of the woman having been pregnant. These include, but are not limited to, prenatal care, delivery, postpartum care, and family planning services.
(ii) Services for other conditions that might complicate the pregnancy include those for diagnoses, illnesses, or medical conditions which might threaten the carrying of the fetus to full term or the safe delivery of the fetus; and
(3) For women who, while pregnant, applied for, were eligible for, and received Medicaid services under the plan, all services under the plan that are pregnancy-related for an extended postpartum period. The postpartum period begins on the last day of pregnancy and extends through the end of the month in which the 60-day period following termination of pregnancy ends.
(b) A State plan must specify that eligible aliens as defined in §§ 435.406(a) and 436.406(a) of this subchapter will receive at least the services provided in paragraph (a) of this section.
(c) A State plan must specify that aliens not defined in §§ 435.406(a) and 436.406(a) of this subchapter will only be provided the limited services specified in § 440.255.
(a) A State plan that includes the medically needy must specify that the medically needy are provided, as a minimum, the following services:
(1) Prenatal care and delivery services for pregnant women.
(2) Ambulatory services, as defined in the State plan, for:
(i) Individuals under age 18; and
(ii) Groups of individuals entitled to institutional services.
(3) Home health services (§ 440.70) to any individual entitled to skilled nursing facility services.
(4) If the State plan includes services in an institution for mental diseases (§ 440.140 or § 440.160) or in an intermediate care facility for the mentally retarded (§ 440.150(c)) for any group of medically needy, either of the following sets of services to each of the medically needy groups:
(i) The services contained in §§ 440.10 through 440.50 and (to the extent nurse-midwives are authorized to practice
(ii) The services contained in any seven of the sections in §§ 440.10 through 440.165.
(5) For women who, while pregnant, applied for, were eligible as medically needy for, and received Medicaid services under the plan, services under the plan that are pregnancy-related (as defined in § 440.210(a)(2)(i) of this subpart) for an extended postpartum period. The postpartum period begins on the last day of pregnancy and extends through the end of the month in which the 60-day period following termination of pregnancy ends.
(b) A State plan must specify that eligible aliens as defined in §§ 435.406(a) and 436.406(a) of this subchapter will receive at least the services provided in paragraphs (a)(4) (i) and (ii) of this section.
(c) A State plan must specify that aliens defined in §§ 435.406(b), 435.406(c), 436.406(b) and 436.406(c) of this subchapter will only be provided the limited services specified in § 440.255.
Any of the services defined in subpart A of this part that are not required under §§ 440.210 and 440.220 may be furnished under the State plan at the State's option.
(a) The plan must specify the amount, duration, and scope of each service that it provides for—
(1) The categorically needy; and
(2) Each covered group of medically needy.
(b) Each service must be sufficient in amount, duration, and scope to reasonably achieve its purpose.
(c) The Medicaid agency may not arbitrarily deny or reduce the amount, duration, or scope of a required service under §§ 440.210 and 440.220 to an otherwise eligible recipient solely because of the diagnosis, type of illness, or condition.
(d) The agency may place appropriate limits on a service based on such criteria as medical necessity or on utilization control procedures.
Except as limited in § 440.250—
(a) The plan must provide that the services available to any categorically needy recipient under the plan are not less in amount, duration, and scope than those services available to a medically needy recipient; and
(b) The plan must provide that the services available to any individual in the following groups are equal in amount, duration, and scope for all recipients within the group:
(1) The categorically needy.
(2) A covered medically needy group.
(a) Skilled nursing facility services (§ 440.40(a)) may be limited to recipients age 21 or older.
(b) Early and periodic screening, diagnosis, and treatment (§ 440.40(b)) must be limited to recipients under age 21.
(c) Family planning services and supplies must be limited to recipients of childbearing age, including minors who can be considered sexually active and who desire the services and supplies.
(d) If covered under the plan, services to recipients in institutions for mental diseases (§ 440.140) must be limited to those age 65 or older.
(e) If covered under the plan, inpatient psychiatric services (§ 440.160) must be limited to recipients under age 22 as specified in § 441.151(c) of this subchapter.
(f) If Medicare benefits under Part B of title XVIII are made available to recipients through a buy-in agreement or payment of premiums, or part or all of the deductibles, cost sharing or similar charges, they may be limited to recipients who are covered by the agreement or payment.
(g) If services in addition to those offered under the plan are made available under a contract between the agency or
(h) Ambulatory services for the medically needy (§ 440.220(a)(2)) may be limited to:
(1) Individuals under age 18; and
(2) Groups of individuals entitled to institutional services.
(i) Services provided under an exception to requirements allowed under § 431.54 may be limited as provided under that exception.
(j) If CMS has approved a waiver of Medicaid requirements under § 431.55, services may be limited as provided by the waiver.
(k) If the agency has been granted a waiver of the requirements of § 440.240 (Comparability of services) in order to provide for home or community-based services under §§ 440.180 or 440.181, the services provided under the waiver need not be comparable for all individuals within a group.
(l) If the agency imposes cost sharing on recipients in accordance with 447.53, the imposition of cost sharing on an individual who is not exempted by one of the conditions in section 447.53(b) shall not require the State to impose copayments on an individual who is eligible for such exemption.
(m) Eligible legalized aliens who are not in the exempt groups described in §§ 435.406(a) and 436.406(a), and considered categorically needy or medically needy must be furnished only emergency services (as defined in § 440.255), and services for pregnant women as defined in section 1916(a)(2)(B) of the Social Security Act for 5 years from the date the alien is granted lawful temporary resident status.
(n) Aliens who are not lawful permanent residents, permanently residing in the United States under color of law, or granted lawful status under section 245A, 210 or 210A of the Immigration and Nationality Act, who, otherwise meet the eligibility requirements of the State plan (except for receipt of AFDC, SSI or a State Supplementary payment) must be furnished only those services necessary to treat an emergency medical condition of the alien as defined in § 440.255(c).
(o) If the agency makes respiratory care services available under § 440.185, the services need not be made available in equal amount, duration, and scope to any individual not eligible for coverage under that section. However, the services must be made available in equal amount, duration, and scope to all individuals eligible for coverage under that section.
(p) A State may provide a greater amount, duration, or scope of services to pregnant women than it provides under its plan to other individuals who are eligible for Medicaid, under the following conditions:
(1) These services must be pregnancy-related or related to any other condition which may complicate pregnancy, as defined in § 440.210(a)(2) of this subpart; and
(2) These services must be provided in equal amount, duration, and scope to all pregnant women covered under the State plan.
(q) [Reserved]
(r) If specified in the plan, targeted case management services may be limited to the following:
(1) Certain geographic areas within a State, without regard to the statewide requirements in § 431.50 of this chapter.
(2) Targeted groups specified by the State.
(a)
(b)
(1) Emergency services required after the sudden onset of a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonably be expected to result in:
(i) Placing the patient's health in serious jeopardy;
(ii) Serious impairment to bodily functions; or
(iii) Serious dysfunction of any bodily organ or part.
(2) Services for pregnant women which are included in the approved State plan. These services include routine prenatal care, labor and delivery, and routine post-partum care. States, at their option, may provide additional plan services for the treatment of conditions which may complicate the pregnancy or delivery.
(c) Effective January 1, 1987, aliens who are not lawfully admitted for permanent residence in the United States or permanently residing in the United States under the color of law must receive the services necessary to treat the condition defined in paragraph (1) of this section if—
(1) The alien has, after sudden onset, a medical condition (including emergency labor and delivery) manifesting itself by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonably be expected to result in:
(i) Placing the patient's health in serious jeopardy;
(ii) Serious impairment to bodily functions; or
(iii) Serious dysfunction of any bodily organ or part, and
(2) The alien otherwise meets the requirements in §§ 435.406(c) and 436.406(c) of this subpart.
The plan must include a description of methods and standards used to assure that services are of high quality.
(a) Except as specified in paragraph (b) of this section, the agency may not require any individual to undergo any medical service, diagnosis, or treatment or to accept any other health service provided under the plan if the individual objects, or in the case of a child, a parent or guardian objects, on religious grounds.
(b) If a physical examination is necessary to establish eligibility based on disability or blindness, the agency may not find an individual eligible for Medicaid unless he undergoes the examination.
At 73 FR 73724, Dec. 3, 2008, subpart C was added, effective Feb. 2, 2009. At 74 FR 5808, Feb. 2, 2009 the effective date was delayed until Apr. 3, 2009. At 74 FR 15221, Apr. 3, 2009 the effective date was delayed until Dec. 31, 2009.
This subpart implements section 1937 of the Act, which authorizes States to provide for medical assistance to one or more groups of Medicaid-eligible recipients specified by the State under an approved State plan amendment through enrollment in coverage that provides benchmark or benchmark-equivalent health care benefit coverage.
(a)
(b)
(c) A State may not require but may offer enrollment in benchmark or benchmark-equivalent coverage to the Medicaid eligible individuals listed in § 440.315. States allowing individuals to opt in must be in compliance with the rules specified at § 440.320.
(d) Any State that opts to offer alternative benchmark or benchmark-equivalent coverage to Medicaid beneficiaries must secure public input prior to the submission of any State plan amendment to CMS.
(e) In implementing benchmark or benchmark-equivalent package, States must comply with the managed care rules at section 1932 of the Act and part 438 of this chapter if benchmark or benchmark-equivalent benefits are provided through managed care plans unless the State demonstrates that such requirements are impractical in the context of, or inconsistent with, methods of offering coverage appropriate to meet the health care needs of the targeted population.
(a)
(b)
For recipients within one (or more) of the following categories, the State plan may offer, but may not require under § 440.310, the opportunity to obtain benefits through enrollment in benchmark or benchmark-equivalent coverage:
(a) The recipient is a pregnant woman who is required to be covered under the State plan under section 1902(a)(10)(A)(i) of the Act.
(b) The recipient qualifies for medical assistance under the State plan on the basis of being blind or disabled (or being treated as being blind or disabled) without regard to whether the individual is eligible for Supplemental Security Income benefits under title XVI on the basis of being blind or disabled and including an individual who is eligible for medical assistance on the basis of section 1902(e)(3) of the Act.
(c) The recipient is entitled to benefits under any part of Medicare.
(d) The recipient is terminally ill and is receiving benefits for hospice care under title XIX.
(e) The recipient is an inpatient in a hospital, nursing facility, intermediate care facility for the mentally retarded, or other medical institution, and is required, as a condition of receiving services in that institution under the State plan, to spend for costs of medical care all but a minimal amount of the individual's income required for personal needs.
(f) The recipient is medically frail or otherwise an individual with special medical needs. For these purposes, the State's definition of individuals with special needs must at least include those individuals described in § 438.50(d)(3) of this chapter.
(g) The recipient qualifies based on medical condition for medical assistance for long-term care services described in section 1917(c)(1)(C) of the Act.
(h) The recipient is an individual with respect to whom aid or assistance is made available under part B of title IV to children in foster care and individuals with respect to whom adoption or foster care assistance is made available under part E of title IV, without regard to age.
(i) The recipient qualifies for medical assistance on the basis of eligibility to receive assistance under a State plan funded under part A of title IV (as in effect on or after welfare reform effective date defined in section 1931(i) of the Act). This provision relates to
(j) The recipient is a woman who is receiving medical assistance by virtue of the application of sections 1902(a)(10)(ii)(XVIII) and 1902(a) of the Act.
(k) The recipient qualifies for medical assistance on the basis of section 1902(a)(10)(A)(ii)(XII) of the Act.
(l) The recipient is not a qualified alien (as defined in section 431 of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996) and receives care and services necessary for the treatment of an emergency medical condition in accordance with section 1903(v) of the Act.
(m) The recipient is determined eligible as medically needy or eligible because of a reduction of countable income based on costs incurred for medical or other remedial care under section 1902(f) of the Act or otherwise based on incurred medical costs.
(a)
(1) In any case in which the State offers an exempt individual the option to obtain coverage in a benchmark or benchmark-equivalent benefit package, the State must effectively inform the individual prior to enrollment that the enrollment is voluntary and that the individual may opt out of the benchmark or benchmark-equivalent coverage at any time and regain immediate access to standard full Medicaid coverage under the State plan.
(2) Prior to any enrollment in benchmark or benchmark-equivalent coverage, the State must inform the exempt recipient of the benefits available under the benchmark or benchmark-equivalent benefit package and provide a comparison of how they differ from the benefits available under the standard full Medicaid program.
(3) The State must document in the exempt recipient's eligibility file that the recipient was informed in accordance with this section prior to enrollment, was given ample time to arrive at an informed choice, and voluntarily chose to enroll in the benchmark or benchmark-equivalent benefit package.
(4) For individuals who the State determines have become exempt individuals while enrolled in benchmark or benchmark-equivalent coverage, the State must comply with the requirements in paragraphs (a)(1) through (a)(3) of this section within 30 days after such determination.
(b) Disenrollment or Opt/Out Process.
(1) The State must act upon requests promptly for exempt individuals who choose to opt out of benchmark or benchmark-equivalent coverage.
(2) The State must have a process in place to ensure that exempt individuals have continuous access to services while opt out requests are being processed.
Subject to requirements in § 440.345 and § 440.365, States may elect to provide any of the following of types of health benefits coverage:
(a) Benchmark coverage in accordance with § 440.330.
(b) Benchmark-equivalent coverage in accordance with § 440.335.
Benchmark coverage is health benefits coverage that is equal to the coverage under one or more of the following benefit plans:
(a)
(b)
(c)
(d)
(a)
(b)
(1) Inpatient and outpatient hospital services.
(2) Physicians' surgical and medical services.
(3) Laboratory and x-ray services.
(4) Well-baby and well-child care, including age-appropriate immunizations.
(5) Other appropriate preventive services, such as emergency services as designated by the Secretary.
(c)
(1) In addition to the categories of services of this section, benchmark-equivalent coverage may include coverage for any additional services in a category included in the benchmark plan or described in section 1905(a) of the Act.
(2) If the benchmark coverage package used by the State for purposes of comparison in establishing the aggregate actuarial value of the benchmark-equivalent package includes any of the following four categories of services: prescription drugs; mental health services; vision services; and hearing services; then the actuarial value of the coverage for each of these categories of service in the benchmark-equivalent coverage package must be at least 75 percent of the actuarial value of the coverage for that category of service in the benchmark plan used for comparison by the State.
(3) If the benchmark coverage package does not cover one of the four categories of services in paragraph (c)(2) of this section, then the benchmark-equivalent coverage package may, but is not required to, include coverage for that category of service.
(a) A State plan amendment that would provide for benchmark-equivalent health benefits coverage described in § 440.335, must include an actuarial report. The actuarial report must contain an actuarial opinion that the benchmark equivalent health benefits coverage meets the actuarial requirements set forth in § 440.335. The report must also specify the benchmark coverage used for comparison.
(b) The actuarial report must state that it was prepared according to the following requirements:
(1) By an individual who is a member of the American Academy of Actuaries (AAA).
(2) Using generally accepted actuarial principles and methodologies of the AAA.
(3) Using a standardized set of utilization and price factors.
(4) Using a standardized population that is representative of the population involved.
(5) Applying the same principles and factors in comparing the value of different coverage (or categories of services).
(6) Without taking into account any differences in coverage based on the method of delivery or means of cost control or utilization used.
(7) Taking into account the ability of the State to reduce benefits by taking into account the increase in actuarial value of health benefits coverage offered under the State plan that results from the limitations on cost sharing (with the exception of premiums) under that coverage.
(c) The actuary preparing the opinion must select and specify the standardized set of factors and the standardized population to be used in paragraphs (b)(3) and (b)(4) of this section.
(d) The State must provide sufficient detail to explain the basis of the methodologies used to estimate the actuarial value or, if requested by CMS, to replicate the State's result.
(a) The State must assure access to early and periodic screening, diagnostic and treatment (EPSDT) services through benchmark or benchmark-equivalent plan benefits or as wrap-around benefits to those plans for any child under 19 years of age eligible under the State plan in a category under section 1902(a)(10)(A) of the Act.
(1)
(2)
(b) Individuals must first seek coverage of EPSDT services through the benchmark or benchmark-equivalent plan before seeking coverage of such through wrap-around benefits.
(a) A State may provide benchmark or benchmark-equivalent coverage by obtaining employer sponsored health plans (either alone or with the addition of wrap-around services covered separately under Medicaid) for individuals with access to private health insurance.
(b) The State must assure that employer sponsored plans meet the requirements of benchmark or benchmark-equivalent coverage, including the cost-effectiveness requirements at § 440.370.
(c) A State may provide benchmark or benchmark-equivalent coverage through a combination of employer sponsored health plans and additional benefit coverage provided by the State that wraps around the employer sponsored health plan which, in the aggregate, results in benchmark or benchmark-equivalent level of coverage for those recipients.
Payment of premiums by the State, net of beneficiary contributions, to obtain benchmark or benchmark-equivalent benefit coverage on behalf of beneficiaries under this section will be treated as medical assistance under section 1905(a) of the Act.
If the State opts to provide additional or wrap-around coverage to individuals enrolled in benchmark or benchmark-equivalent plans, the State plan must describe the populations covered and the payment methodology for these services. Additional or wrap-around services must be in categories that are within the scope of the benchmark coverage, or are described in section 1905(a) of the Act.
If a State provides benchmark or benchmark-equivalent coverage to individuals, it must assure that the individual has access, through that coverage or otherwise, to rural health
Benchmark and benchmark-equivalent coverage and any additional benefits must be provided in accordance with Federal upper payment limits, procurement requirements and other economy and efficiency principles that would otherwise be applicable to the services or delivery system through which the coverage and benefits are obtained.
States have the option to amend their State plan to provide benchmark or benchmark-equivalent coverage to recipients without regard to comparability or requirements relating to the scope of coverage other than those contained in this subpart.
States have the option to amend their State plan to provide benchmark or benchmark-equivalent coverage to recipients without regard to statewideness.
(a) States have the option to amend their State plan to provide benchmark or benchmark-equivalent coverage to recipients without regard to the requirements for free choice of provider in § 431.51 of this chapter.
(b) States may restrict recipients to obtaining services from (or through) selectively procured provider plans or practitioners that meet, accept, and comply with reimbursement, quality and utilization standards under the State Plan, to the extent that the restrictions imposed meet the following requirements:
(1) Do not discriminate among classes of providers on grounds unrelated to their demonstrated effectiveness and efficiency in providing the benchmark benefit package.
(2) Do not apply in emergency circumstances.
(3) Does not apply to family planning providers.
(4) Require that all provider plans are paid on a timely basis in the same manner as health care practitioners must be paid under § 447.45 of this chapter.
A State may at its option amend its State plan to provide benchmark or benchmark-equivalent coverage to recipients without regard to the assurance of transportation to medically necessary services requirement specified in § 431.53 of this chapter.
Sec. 1102 of the Social Security Act (42 U.S.C. 1302).
This part sets forth State plan requirements and limits on FFP for specific services defined in part 440 of this subchapter. Standards for payments for services provided in intermediate care facilities and skilled nursing facilities are set forth in part 442 of this subchapter.
This subpart is based on the following sections of the Act which state requirements and limits on the services specified or provide Secretarial authority to prescribe regulations relating to services:
(a) Section 1102 for end-stage renal disease (§ 441.40).
(b) Section 1138(b) for organ procurement organization services (§ 441.13(c)).
(c) Sections 1902(a)(10)(A) and 1905(a)(21) for nurse practitioner services (§ 441.22).
(d) Sections 1902(a)(10)(D) and 1905(a)(7) for home health services (§ 441.15).
(e) Section 1903(i)(1) for organ transplant procedures (§ 441.35).
(f) Section 1903(i)(5) for certain prescribed drugs (§ 441.25).
(g) Section 1903(i)(6) for prohibition (except in emergency situations) of FFP in expenditures for inpatient hospital tests that are not ordered by the attending physician or other licensed practitioner (§ 441.12).
(h) Section 1903(i)(18) for the requirement that each home health agency provide the Medicaid agency with a surety bond (§ 441.16).
(i) Section 1905(a)(4)(C) for family planning (§ 441.20).
(j) Sections 1905 (a)(12) and (e) for optometric services (§ 441.30).
(k) Section 1905(a)(17) for nurse-midwife services (§ 441.21).
(l) Section 1905(a) (following (a)(24)) for prohibition of FFP in expenditures for certain services (§ 441.13).
(m) Section 1905(a)(19) and 1915(g) of the Act for case management services as set forth in § 441.18 and section 8435 of the Technical and Miscellaneous Revenue Act of 1988.
(a)
(1) The Medicaid payments are for recipients admitted to the facility before the effective date of termination or expiration.
(2) The State agency is making reasonable efforts to transfer those recipients to other facilities or to alternate care.
(b)
(1) The effective date of termination of the facility's provider agreement by CMS;
(2) The effective date of termination of the facility's Medicaid provider agreement by the Medicaid agency on its own volition; or
(3) In the case of an ICF/MR, the later of—
(i) The effective date of termination or nonrenewal of the facility's provider agreement by the Medicaid agency on its own volition; or
(ii) The date of issuance of an administrative hearing decision that upholds the agency's termination or nonrenewal action.
(c)
(1) Inpatient hospital services.
(2) Inpatient hospital services for individuals age 65 or older in an institution for mental diseases.
(3) Nursing facility services for individuals age 21 or older.
(4) Nursing facility services for individuals age 65 or older in an institution for mental diseases.
(5) Inpatient psychiatric services for individuals under age 21.
(6) Nursing facility services for individuals under 21.
(7) Intermediate care facility services for the mentally retarded.
Except in an emergency situation (see § 440.170(e)(1) of this chapter for definition), FFP is not available in expenditures for inpatient hospital tests unless the tests are specifically ordered by the attending physician or other licensed practitioner, acting within the scope of practice as defined under State law, who is responsible for the diagnosis or treatment of a particular patient's condition.
(a) FFP is not available in expenditures for services for—
(1) Any individual who is in a public institution, as defined in § 435.1010 of this chapter; or
(2) Any individual who is under age 65 and is in an institution for mental diseases, except an individual who is under age 22 and receiving inpatient psychiatric services under subpart D of this part.
(b) With the exception of active treatment services (as defined in § 483.440(a) of this chapter for residents of ICFs/MR and in § 441.154 for individuals under age 21 receiving inpatient psychiatric services), payments to institutions for the mentally retarded or persons with related conditions and to psychiatric facilities or programs providing inpatient psychiatric services to individuals under age 21 may not include reimbursement for formal educational services or for vocational services. Formal educational services relate to training in traditional academic subjects. Subject matter rather than setting, time of day, or class size determines whether a service is educational. Traditional academic subjects include, but are not limited to, science, history, literature, foreign languages, and mathematics. Vocational services relate to organized programs that are directly related to the preparation of individuals for paid or unpaid employment. An example of vocational services is time-limited vocational training provided as a part of a regularly scheduled class available to the general public.
(c) FFP is not available in expenditures for services furnished by an organ procurement organization on or after April 1, 1988, that does not meet the requirements of part 486 subpart G of this chapter.
With respect to the services defined in § 440.70 of this subchapter, a State plan must provide that—
(a) Home health services include, as a minimum—
(1) Nursing services;
(2) Home health aide services; and
(3) Medical supplies, equipment, and appliances.
(b) The agency provides home health services to—
(1) Categorically needy recipients age 21 or over;
(2) Categorically needy recipients under age 21, if the plan provides skilled nursing facility services for them; individuals; and
(3) Medically needy recipients to whom skilled nursing facility services are provided under the plan.
(c) The eligibility of a recipient to receive home health services does not depend on his need for or discharge from institutional care.
(d) The agency providing home health services meets the capitalization requirements included in § 489.28 of this chapter.
(a)
(b)
(c)
(1) Obtain a surety bond that meets the requirements of this section and instructions issued by the Medicaid agency; and
(2) Furnish a copy of the surety bond to the Medicaid agency.
(d)
(e)
(f)
(1) An authorized Surety is a surety company that—
(i) Has been issued a Certificate of Authority by the U.S. Department of the Treasury in accordance with 31 U.S.C. 9304 to 9308 and 31 CFR parts 223, 224, and 225 as an acceptable surety on Federal bonds and the Certificate has neither expired nor been revoked;
(ii) Has not been determined by the Medicaid agency to be an unauthorized Surety for the purpose of an HHA obtaining a surety bond under this section; and
(iii) Meets other conditions, as specified by the Medicaid agency.
(2) The Medicaid agency may determine that a surety company is an unauthorized Surety under this section—
(i) If, upon request by the Medicaid agency, the surety company fails to furnish timely confirmation of the issuance of, and the validity and accuracy of information appearing on, a surety bond that an HHA presents to the Medicaid agency that shows the surety company as Surety on the bond;
(ii) If, upon presentation by the Medicaid agency to the surety company of a request for payment on a surety bond and of sufficient evidence to establish the surety company's liability on the bond, the surety company fails to timely pay the Medicaid agency in full the amount requested up to the face amount of the bond; or
(iii) For other good cause.
(3) The Medicaid agency must specify the manner by which public notification of a determination under paragraph (f)(2) of this section is given and the effective date of the determination.
(4) A determination by the Medicaid agency that a surety company is an unauthorized Surety under paragraph (f)(2) of this section—
(i) Has effect only within the State; and
(ii) Is not a debarment, suspension, or exclusion for the purposes of Executive Order No. 12549 (3 CFR 1986 Comp., p. 189).
(g)
(2)
(3)
(4)
(5)
(6)
(7)
(h)
(1) The bond must guarantee that, upon written demand by the Medicaid agency to the Surety for payment under the bond and the Medicaid agency furnishing to the Surety sufficient evidence to establish the Surety's liability under the bond, the Surety will timely pay the Medicaid agency the amount so demanded, up to the stated amount of the bond.
(2) The bond must provide that the Surety is liable for uncollected overpayments, as defined in paragraph (a), provided such uncollected overpayments are determined during the term of the bond and regardless of when the overpayments took place. Further, the bond must provide that the Surety remains liable if the HHA fails to furnish a subsequent annual bond that meets the requirements of this subpart or fails to furnish a rider for a year for which a rider is required to be submitted, or if the HHA's provider agreement terminates and that the Surety's liability shall be based on the last bond or rider in effect for the HHA, which shall then remain in effect for an additional 2-year period.
(3) The bond must provide that the Surety's liability to the Medicaid agency is not extinguished by any of the following:
(i) Any action by the HHA or the Surety to terminate or limit the scope or term of the bond. The Surety's liability may be extinguished, however, when—
(A) The Surety furnishes the Medicaid agency with notice of such action not later than 10 days after receiving notice from the HHA of action by the HHA to terminate or limit the scope of the bond, or not later than 60 days before the effective date of such action by the Surety; or
(B) The HHA furnishes the Medicaid agency with a new bond that meets the requirements of both this section and the Medicaid agency.
(ii) The Surety's failure to continue to meet the requirements of paragraph (f)(1) of this section or the Medicaid agency's determination that the surety company is an unauthorized surety under paragraph (f)(2) of this section.
(iii) Termination of the HHA's provider agreement described under § 431.107 of this subchapter.
(iv) Any action by the Medicaid agency to suspend, offset, or otherwise recover payments to the HHA.
(v) Any action by the HHA to—
(A) Cease operation;
(B) Sell or transfer any assets or ownership interest;
(C) File for bankruptcy; or
(D) Fail to pay the Surety.
(vi) Any fraud, misrepresentation, or negligence by the HHA in obtaining the surety bond or by the Surety (or by the Surety's agent, if any) in issuing the surety bond, except that any fraud, misrepresentation, or negligence by the HHA in identifying to the Surety (or to the Surety's agent) the amount of Medicaid payments upon which the amount of the surety bond is determined shall not cause the Surety's liability to the Medicaid agency to exceed the amount of the bond.
(vii) The HHA's failure to exercise available appeal rights under Medicaid or to assign such rights to the Surety (provided the Medicaid agency permits such rights to be assigned).
(4) The bond must provide that actions under the bond may be brought by the Medicaid agency or by an agent that the Medicaid agency designates.
(i)
(2)
(i) An annual bond (that is, a bond that specifies an effective annual period that corresponds to an annual period specified by the Medicaid agency); or
(ii) A continuous bond (that is, a bond that remains in full force and effect from term to term unless it is terminated or canceled as provided for in the bond or as otherwise provided by law) that is updated by the Surety for a particular period, via the issuance of a “rider,” when the bond amount changes. For the purposes of this section, “Rider” means a notice issued by a Surety that a change to a bond has occurred or will occur. If the HHA has submitted a continuous bond and there is no increase or decrease in the bond amount, no action is necessary by the HHA to submit a rider as long as the continuous bond remains in full force and effect.
(3)
(ii) An HHA that seeks to become a participating HHA through the purchase or transfer of assets or ownership interest of a participating or formerly participating HHA must also ensure that the surety bond is effective from the date of such purchase or transfer.
(4)
(5)
(6)
(j)
(2) The Medicaid agency must refuse to enter into a provider agreement with an HHA if an HHA seeking to become a participating HHA fails to obtain and file timely a surety bond in accordance with this section and instructions issued by the State Medicaid agency.
(k)
(2) The Medicaid agency may terminate the HHA's provider agreement or refuse to enter into a provider agreement if an HHA fails to timely furnish sufficient evidence at the Medicaid agency's request to demonstrate compliance with the requirements of this section.
(l)
(m)
(a) The plan must provide for payment of laboratory services as defined in § 440.30 of this subchapter if provided by—
(1) An independent laboratory that meets the requirements for participation in the Medicare program found in § 405.1316 of this chapter;
(2) A hospital-based laboratory that meets the requirements for participation in the Medicare program found in § 482.27 of this chapter;
(3) A rural health clinic, as defined in § 491.9 of this chapter; or
(4) A skilled nursing facility—based clinical laboratory, as defined in § 405.1128(a) of this chapter.
(b) Except as provided under paragraph (c), if a laboratory or other entity is requesting payment under Medicaid for testing for the presence of the human immunodeficiency virus (HIV) antibody or for the isolation and identification of the HIV causative agent as described in § 405.1316(f) (2) and (3) of this chapter, the laboratory records must contain the name and other identification of the person from whom the specimen was taken.
(c) An agency may choose to approve the use of alternative identifiers, in place of the requirement for patient's name, in paragraph (b) of this section for HIV antibody or causative agent testing of Medicaid recipients.
(a) If a State plan provides for case management services (including targeted case management services), as defined in § 440.169 of this chapter, the State must meet the following requirements:
(1) Allow individuals the free choice of any qualified Medicaid provider within the specified geographic area identified in the plan when obtaining case management services, in accordance with § 431.51 of this chapter, except as specified in paragraph (b) of this section.
(2) Not use case management (including targeted case management) services to restrict an individual's access to other services under the plan.
(3) Not compel an individual to receive case management services, condition receipt of case management (or targeted case management) services on the receipt of other Medicaid services, or condition receipt of other Medicaid services on receipt of case management (or targeted case management) services.
(4) Indicate in the plan that case management services provided in accordance with section 1915(g) of the Act will not duplicate payments made to public agencies or private entities under the State plan and other program authorities;
(5) [Reserved]
(6) Prohibit providers of case management services from exercising the agency's authority to authorize or deny the provision of other services under the plan.
(7) Require providers to maintain case records that document for all individuals receiving case management as follows:
(i) The name of the individual.
(ii) The dates of the case management services.
(iii) The name of the provider agency (if relevant) and the person providing the case management service.
(iv) The nature, content, units of the case management services received and whether goals specified in the care plan have been achieved.
(v) Whether the individual has declined services in the care plan.
(vi) The need for, and occurrences of, coordination with other case managers.
(vii) A timeline for obtaining needed services.
(viii) A timeline for reevaluation of the plan.
(8) Include a separate plan amendment for each group receiving case management services that includes the following:
(i) Defines the group (and any subgroups within the group) eligible to receive the case management services.
(ii) Identifies the geographic area to be served.
(iii) Describes the case management services furnished, including the types of monitoring.
(iv) Specifies the frequency of assessments and monitoring and provides a justification for those frequencies.
(v) Specifies provider qualifications that are reasonably related to the population being served and the case management services furnished.
(vi) [Reserved]
(vii) Specifies if case management services are being provided to Medicaid-eligible individuals who are in institutions (except individuals between ages 22 and 64 who are served in IMDs or individuals who are inmates of public institutions).
(9) Include a separate plan amendment for each subgroup within a group if any of the following differs among the subgroups:
(i) The case management services to be furnished;
(ii) The qualifications of case management providers; or
(iii) The methodology under which case management providers will be paid.
(b) If the State limits qualified providers of case management services for target groups of individuals with developmental disability or chronic mental illness, in accordance with § 431.51(a)(4) of this chapter, the plan must identify any limitations to be imposed on the providers and specify how these limitations enable providers to ensure that individuals within the target groups receive needed services.
(c) Case management does not include, and FFP is not available in expenditures for, services defined in § 441.169 of this chapter when the case management activities constitute the direct delivery of underlying medical, educational, social, or other services to which an eligible individual has been referred, including for foster care programs, services such as, but not limited to, the following:
(1) Research gathering and completion of documentation required by the foster care program.
(2) Assessing adoption placements.
(3) Recruiting or interviewing potential foster care parents.
(4) Serving legal papers.
(5) Home investigations.
(6) Providing transportation.
(7) Administering foster care subsidies.
(8) Making placement arrangements.
(d) After the State assesses whether the activities are within the scope of
For recipients eligible under the plan for family planning services, the plan must provide that each recipient is free from coercion or mental pressure and free to choose the method of family planning to be used.
If a State plan, under § 440.210 or 440.220 of this subchapter, provides for nurse-midwife services, as defined in § 440.165, the plan must provide that the nurse-midwife may enter into an independent provider agreement, without regard to whether the nurse-midwife is under the supervision of, or associated with, a physician or other health care provider.
With respect to nurse practitioner services that meet the definition of § 440.166(a) and the requirements of either § 440.166(b) or § 440.166(c), the State plan must meet the following requirements:
(a) Provide that nurse practitioner services are furnished to the categorically needy.
(b) Specify whether those services are furnished to the medically needy.
(c) Provide that services furnished by a nurse practitioner, regardless of whether the nurse practitioner is under the supervision of, or associated with, a physician or other health care provider, may—
(1) Be reimbursed by the State Medicaid agency through an independent provider agreement between the State and the nurse practitioner; or
(2) Be paid through the employing provider.
(a) FFP is not available in expenditures for the purchase or administration of any drug product that meets all of the following conditions:
(1) The drug product was approved by the Food and Drug Administration (FDA) before October 10, 1962.
(2) The drug product is available only through prescription.
(3) The drug product is the subject of a notice of opportunity for hearing issued under section 505(e) of the Federal Food, Drug, and Cosmetic Act and published in the
(4) The drug product is presently not subject to a determination by FDA, made under its efficacy review program (see 21 CFR 310.6 for an explanation of this program), that there is a compelling justification of the drug product's medical need.
(b) FFP is not available in expenditures for the purchase or administration of any drug product that is identical, related, or similar, as defined in 21 CFR 310.6, to a drug product that meets the conditions of paragraph (a) of this section.
The plan must provide for payment of optometric services as physician services, whether furnished by an optometrist or a physician, if—
(a) The plan does not provide for payment for services provided by an optometrist, except for eligibility determinations under §§ 435.531 and 436.531 of this subchapter, but did provide for those services at an earlier period; and
(b) The plan specifically provides that physicians' services include services an optometrist is legally authorized to perform.
(a) FFP is available in expenditures for services furnished in connection with organ transplant procedures only if the State plan includes written standards for the coverage of those procedures, and those standards provide that—
(1) Similarly situated individuals are treated alike; and
(2) Any restriction on the practitioners or facilities that may provide organ transplant procedures is consistent with the accessibility of high quality care to individuals eligible for the procedures under the plan.
(b) Nothing in paragraph (a) permits a State to provide, under its plan, services that are not reasonable in amount, duration, and scope to achieve their purpose.
FFP in expenditures for services described in subpart A of part 440 is available for facility treatment of end-stage renal disease only if the facility has been approved by the Secretary to furnish those services under Medicare. This requirement for approval of the facility does not apply under emergency conditions permitted under Medicare (see § 482.2 of this chapter).
This subpart implements sections 1902(a)(43) and 1905(a)(4)(B) of the Social Security Act, by prescribing State plan requirements for providing early and periodic screening and diagnosis of eligible Medicaid recipients under age 21 to ascertain physical and mental defects, and providing treatment to correct or ameliorate defects and chronic conditions found.
A State plan must provide that the Medicaid agency meets the requirements of §§ 441.56-441.62, with respect to EPSDT services, as defined in § 440.40(b) of this subchapter.
(a)
(1) Provide for a combination of written and oral methods designed to inform effectively all EPSDT eligible individuals (or their families) about the EPSDT program.
(2) Using clear and nontechnical language, provide information about the following—
(i) The benefits of preventive health care;
(ii) The services available under the EPSDT program and where and how to obtain those services;
(iii) That the services provided under the EPSDT program are without cost to eligible individuals under 18 years of age, and if the agency chooses, to those 18 or older, up to age 21, except for any enrollment fee, premium, or similar charge that may be imposed on medically needy recipients; and
(iv) That necessary transportation and scheduling assistance described in § 441.62 of this subpart is available to the EPSDT eligible individual upon request.
(3) Effectively inform those individuals who are blind or deaf, or who cannot read or understand the English language.
(4) Provide assurance to CMS that processes are in place to effectively inform individuals as required under this paragraph, generally, within 60 days of the individual's initial Medicaid eligibility determination and in the case of families which have not utilized EPSDT services, annually thereafter.
(b)
(i) Comprehensive health and developmental history.
(ii) Comprehensive unclothed physical examination.
(iii) Appropriate vision testing.
(iv) Appropriate hearing testing.
(v) Appropriate laboratory tests.
(vi) Dental screening services furnished by direct referral to a dentist for children beginning at 3 years of age. An agency may request from CMS an exception from this age requirement (within an outer limit of age 5) for a two year period and may request additional two year exceptions. If an agency requests an exception, it must demonstrate to CMS's satisfaction that there is a shortage of dentists that prevents the agency from meeting the age 3 requirement.
(2) Screening services in paragraph (b)(1) of this section must be provided in accordance with reasonable standards of medical and dental practice determined by the agency after consultation with recognized medical and dental organizations involved in child health care.
(c)
(1) Diagnosis of and treatment for defects in vision and hearing, including eyeglasses and hearing aids;
(2) Dental care, at as early an age as necessary, needed for relief of pain and infections, restoration of teeth and maintenance of dental health; and
(3) Appropriate immunizations. (If it is determined at the time of screening that immunization is needed and appropriate to provide at the time of screening, then immunization treatment must be provided at that time.)
(d)
(1) Records and program manuals;
(2) A description of its screening package under paragraph (b) of this section; and
(3) Copies of rules and policies describing the methods used to assure that the informing requirement of paragraph (a)(1) of this section is met.
(e)
Under the EPSDT program, the agency may provide for any other medical or remedial care specified in part 440 of this subchapter, even if the agency does not otherwise provide for these services to other recipients or provides for them in a lesser amount, duration, or scope.
The agency must implement a periodicity schedule for screening services that—
(a) Meets reasonable standards of medical and dental practice determined by the agency after consultation with recognized medical and dental organizations involved in child health care;
(b) Specifies screening services applicable at each stage of the recipient's life, beginning with a neonatal examination, up to the age at which an individual is no longer eligible for EPSDT services; and
(c) At the agency's option, provides for needed screening services as determined by the agency, in addition to the otherwise applicable screening services specified under paragraph (b) of this section.
(a) The agency must provide the screening services described in
(b) To avoid duplicate screening services, the agency need not provide requested screening services to an EPSDT eligible if written verification exists that the most recent age-appropriate screening services, due under the agency's periodicity schedule, have already been provided to the eligible.
(a)
(1) With the exception of dental services required under § 441.56, screening, diagnosis, treatment, and referral for follow-up services as required under this subpart.
(2) Maintenance of the recipient's consolidated health history, including information received from other providers.
(3) Physicians' services as needed by the recipient for acute, episodic or chronic illnesses or conditions.
(4) At the provider's option, provision of dental services required under § 441.56 or direct referral to a dentist to provide dental services required under § 441.56(b)(1)(vi). The provider must specify in the agreement whether dental services or referral for dental services are provided. If the provider does not choose to provide either service, then the provider must refer recipients to the agency to obtain those dental services required under § 441.56.
(5) At the provider's option, provision of all or part of the transportation and scheduling assistance as required under § 441.62. The provider must specify in the agreement the transportation and scheduling assistance to be furnished. If the provider does not choose to provide some or all of the assistance, then the provider must refer recipients to the agency to obtain the transportation and scheduling assistance required under § 441.62.
(b)
(c)
(d)
(e) If the agreement in paragraph (a) of this section does not provide for all or part of the transportation and scheduling assistance required under § 441.62, or for dental service under § 441.56, the agency must provide for those services to the extent they are not provided for in the agreement.
(a) The agency must provide referral assistance for treatment not covered by the plan, but found to be needed as a result of conditions disclosed during screening and diagnosis. This referral assistance must include giving the family or recipient the names, addresses, and telephone numbers of providers who have expressed a willingness to furnish uncovered services at little or no expense to the family.
(b) The agency must make available a variety of individual and group providers qualified and willing to provide EPSDT services.
(c) The agency must make appropriate use of State health agencies, State vocational rehabilitation agencies, and Title V grantees (Maternal and Child Health/Crippled Children's Services). Further, the agency should
The agency must offer to the family or recipient, and provide if the recipient requests—
(a) Necessary assistance with transportation as required under § 431.53 of this chapter; and
(b) Necessary assistance with scheduling appointments for services.
This subpart implements section 1905(a)(14) of the Act, which authorizes State plans to provide for inpatient hospital services, skilled nursing services, and intermediate care facility services for individuals age 65 or older in an institution for mental diseases, and sections 1902(a)(20)(B) and (C) and 1902(a)(21), which prescribe the conditions a State must meet to offer these services. (See § 431.620 of this subchapter for regulations implementing section 1902(a)(20)(A), which prescribe interagency requirements related to these services.)
A State plan that includes Medicaid for individuals age 65 or older in institutions for mental diseases must provide that the requirements of this subpart are met.
(a) The Medicaid agency must provide for a recorded individual plan of treatment and care to ensure that institutional care maintains the recipient at, or restores him to, the greatest possible degree of health and independent functioning.
(b) The plan must include—
(1) An initial review of the recipient's medical, psychiatric, and social needs—
(i) Within 90 days after approval of the State plan provision for services in institutions for mental disease; and
(ii) After that period, within 30 days after the date payments are initiated for services provided a recipient.
(2) Periodic review of the recipient's medical, psychiatric, and social needs;
(3) A determination, at least quarterly, of the recipient's need for continued institutional care and for alternative care arrangements;
(4) Appropriate medical treatment in the institution; and
(5) Appropriate social services.
(a) The agency must develop alternate plans of care for each recipient age 65 or older who would otherwise need care in an institution for mental diseases.
(b) These alternate plans of care must—
(1) Make maximum use of available resources to meet the recipient's medical, social, and financial needs; and
(2) In Guam, Puerto Rico, and the Virgin Islands, make available appropriate social services authorized under sections 3(a)(4) (i) and (ii) or 1603(a)(4)(A) (i) and (ii) of the Act.
The agency must have methods of administration to ensure that its responsibilities under this subpart are met.
(a) If the plan includes services in public institutions for mental diseases, the agency must show that the State is making satisfactory progress in developing and implementing a comprehensive mental health program.
(b) The program must—
(1) Cover all ages;
(2) Use mental health and public welfare resources; including—
(i) Community mental health centers;
(ii) Nursing homes; and
(iii) Other alternatives to public institutional care; and
(3) Include joint planning with State authorities.
(c) The agency must submit annual progress reports within 3 months after the end of each fiscal year in which Medicaid is provided under this subpart.
This subpart specifies requirements applicable if a State provides inpatient psychiatric services to individuals under age 21, as defined in § 440.160 of this subchapter and authorized under section 1905 (a)(16) and (h) of the Act.
(a) Inpatient psychiatric services for individuals under age 21 must be:
(1) Provided under the direction of a physician;
(2) Provided by—
(i) A psychiatric hospital or an inpatient psychiatric program in a hospital, accredited by the Joint Commission on Accreditation of Healthcare Organizations; or
(ii) A psychiatric facility that is not a hospital and is accredited by the Joint Commission on Accreditation of Healthcare Organizations, the Commission on Accreditation of Rehabilitation Facilities, the Council on Accreditation of Services for Families and Children, or by any other accrediting organization with comparable standards that is recognized by the State.
(3) Provided before the individual reaches age 21, or, if the individual was receiving the services immediately before he or she reached age 21, before the earlier of the following—
(i) The date the individual no longer requires the services; or
(ii) The date the individual reaches 22; and
(4) Certified in writing to be necessary in the setting in which the services will be provided (or are being provided in emergency circumstances) in accordance with § 441.152.
(b) Inpatient psychiatric services furnished in a psychiatric residential treatment facility as defined in § 483.352 of this chapter, must satisfy all requirements in subpart G of part 483 of this chapter governing the use of restraint and seclusion.
(a) A team specified in § 441.154 must certify that—
(1) Ambulatory care resources available in the community do not meet the treatment needs of the recipient;
(2) Proper treatment of the recipient's psychiatric condition requires services on an inpatient basis under the direction of a physician; and
(3) The services can reasonably be expected to improve the recipient's condition or prevent further regression so that the services will no longer be needed.
(b) The certification specified in this section and in § 441.153 satisfies the utilization control requirement for physician certification in §§ 456.60, 456.160, and 456.360 of this subchapter.
Certification under § 441.152 must be made by terms specified as follows:
(a) For an individual who is a recipient when admitted to a facility or program, certification must be made by an independent team that—
(1) Includes a physician;
(2) Has competence in diagnosis and treatment of mental illness, preferably in child psychiatry; and
(3) Has knowledge of the individual's situation.
(b) For an individual who applies for Medicaid while in the facility of program, the certification must be—
(1) Made by the team responsible for the plan of care as specified in § 441.156; and
(2) Cover any period before application for which claims are made.
(c) For emergency admissions, the certification must be made by the team responsible for the plan of care
Inpatient psychiatric services must involve “active treatment”, which means implementation of a professionally developed and supervised individual plan of care, described in § 441.155 that is—
(a) Developed and implemented no later than 14 days after admission; and
(b) Designed to achieve the recipient's discharge from inpatient status at the earliest possible time.
(a) “Individual plan of care” means a written plan developed for each recipient in accordance with §§ 456.180 and 456.181 of this chapter, to improve his condition to the extent that inpatient care is no longer necessary.
(b) The plan of care must—
(1) Be based on a diagnostic evaluation that includes examination of the medical, psychological, social, behavioral and developmental aspects of the recipient's situation and reflects the need for inpatient psychiatric care;
(2) Be developed by a team of professionals specified under § 441.156 in consultation with the recipient; and his parents, legal guardians, or others in whose care he will be released after discharge;
(3) State treatment objectives;
(4) Prescribe an integrated program of therapies, activities, and experiences designed to meet the objectives; and
(5) Include, at an appropriate time, post-discharge plans and coordination of inpatient services with partial discharge plans and related community services to ensure continuity of care with the recipient's family, school, and community upon discharge.
(c) The plan must be reviewed every 30 days by the team specified in § 441.156 to—
(1) Determine that services being provided are or were required on an inpatient basis, and
(2) Recommend changes in the plan as indicated by the recipient's overall adjustment as an inpatient.
(d) The development and review of the plan of care as specified in this section satisfies the utilization control requirements for—
(1) Recertification under §§ 456.60(b), 456.160(b), and 456.360(b) of this subchapter; and
(2) Establishment and periodic review of the plan of care under §§ 456.80, 456.180, and 456.380 of this subchapter.
(a) The individual plan of care under § 441.155 must be developed by an interdisciplinary team of physicians and other personnel who are employed by, or provide services to patients in, the facility.
(b) Based on education and experience, preferably including competence in child psychiatry, the team must be capable of—
(1) Assessing the recipient's immediate and long-range therapeutic needs, developmental priorities, and personal strengths and liabilities;
(2) Assessing the potential resources of the recipient's family;
(3) Setting treatment objectives; and
(4) Prescribing therapeutic modalities to achieve the plan's objectives.
(c) The team must include, as a minimum, either—
(1) A Board-eligible or Board-certified psychiatrist;
(2) A clinical psychologist who has a doctoral degree and a physician licensed to practice medicine or osteopathy; or
(3) A physician licensed to practice medicine or osteopathy with specialized training and experience in the diagnosis and treatment of mental diseases, and a psychologist who has a master's degree in clinical psychology or who has been certified by the State or by the State psychological association.
(d) The team must also include one of the following:
(1) A psychiatric social worker.
(2) A registered nurse with specialized training or one year's experience in treating mentally ill individuals.
(3) An occupational therapist who is licensed, if required by the State, and who has specialized training or one
(4) A psychologist who has a master's degree in clinical psychology or who has been certified by the State or by the State psychological association.
FFP is available only if the State maintains fiscal effort as prescribed under this subpart.
(a) For purposes of § 441.182:
(1) The base year is the 4-quarter period ending December 31, 1971.
(2) Quarterly per capita non-Federal expenditures are expenditures for inpatient psychiatric services determined by reimbursement principles under Medicare. (See part 405, subpart D.)
(3) The number of individuals receiving inpatient psychiatric services in the current quarter means—
(i) The number of individuals receiving services for the full quarter; plus
(ii) The full quarter composite number of individuals receiving services for less than a full quarter.
(4) In determining the per capita expenditures for the base year, the Medicaid agency must compute the number of individuals receiving services in a manner similar to that in paragraph (a)(3) of this section.
(5) Non-Federal expenditures means the total amount of funds expended by the State and its political subdivisions, excluding Federal funds received directly or indirectly from any source.
(6) Expenditures for the current calendar quarter exclude Federal funds received directly or indirectly from any source.
(b) As a basis for determining the correct amount of Federal payments, each State must submit estimated and actual cost data and other information necessary for this purpose in the form and at the times specified in this subchapter and by CMS guidelines.
(c) The agency must have on file adequate records to substantiate compliance with the requirements of § 441.182 and to ensure that all necessary adjustments have been made.
(d) Facilities that did not meet the requirements of §§ 441.151-441.156 in the base year, but are providing inpatient psychiatric services under those sections in the current quarter, must be included in the maintenance of effort computation if, during the base year, they were—
(1) Providing inpatient psychiatric services for individuals under age 21; and
(2) Receiving State aid.
(a) For expenditures for inpatient psychiatric services for individuals under age 21, in any calendar quarter, FFP is available only to the extent that the total State Medicaid expenditures in the current quarter for inpatient psychiatric services and outpatient psychiatric treatment for individuals under age 21 exceed the sum of the following:
(1) The total number of individuals receiving inpatient psychiatric services in the current quarter times the average quarterly per capita non-Federal expenditures for the base year; and
(2) The average non-Federal quarterly expenditures for the base year for outpatient psychiatric services for individuals under age 21.
(b) FFP is available for 100 percent of the increase in expenditures over the base year period, but may not exceed the Federal medical assistance percentage times the expenditures under this subpart for inpatient psychiatric services for individuals under age 21.
This subpart implements section 402 of Pub. L. 97-12, and subsequent laws that appropriate funds for the Medicaid program, including section 204 of Pub. L. 98-619. All of these laws prohibit the use of Federal funds to pay for abortions except when continuation of the pregnancy would endanger the mother's life.
As used in this subpart, “physician” means a doctor of medicine or osteopathy who is licensed to practice in the State.
FFP is not available in expenditures for an abortion unless the conditions specified in §§ 441.203 and 441.206 are met.
FFP is available in expenditures for an abortion when a physician has found, and certified in writing to the Medicaid agency, that on the basis of his professional judgment, the life of the mother would be endangered if the fetus were carried to term. The certification must contain the name and address of the patient.
FFP is not available in any expenditures for abortions or other medical procedures otherwise provided for under § 441.203 if the Medicaid agency has paid without first having received the certifications and documentation specified in that section.
FFP is available in expenditures for drugs or devices to prevent implantation of the fertilized ovum and for medical procedures necessary for the termination of an ectopic pregnancy.
Medicaid agencies must maintain copies of the certifications and documentation specified in § 441.203 for 3 years under the recordkeeping requirements at 45 CFR 74.20.
This subpart applies to sterilizations and hysterectomies reimbursed under Medicaid.
As used in this subpart:
A State plan must provide that the Medicaid agency will make payment under the plan for sterilization procedures and hysterectomies only if all the requirements of this subpart were met.
FFP is available in expenditures for the sterilization of an individual only if—
(a) The individual is at least 21 years old at the time consent is obtained;
(b) The individual is not a mentally incompetent individual;
(c) The individual has voluntarily given informed consent in accordance
(d) At least 30 days, but not more than 180 days, have passed between the date of informed consent and the date of the sterilization, except in the case of premature delivery or emergency abdominal surgery. An individual may consent to be sterilized at the time of a premature delivery or emergency abdominal surgery, if at least 72 hours have passed since he or she gave informed consent for the sterilization. In the case of premature delivery, the informed consent must have been given at least 30 days before the expected date of delivery.
FFP is not available for the sterilization of a mentally incompetent or institutionalized individual.
(a) FFP is not available in expenditures for a hysterectomy if—
(1) It was performed solely for the purpose of rendering an individual permanently incapable of reproducing; or
(2) If there was more than one purpose to the procedure, it would not have been performed but for the purpose of rendering the individual permanently incapable of reproducing.
(b) FFP is available in expenditures for a hysterectomy not covered by paragraph (a) of this section only under the conditions specified in paragraph (c), (d), or (e) of this section.
(c) FFP is available if—
(1) The person who secured authorization to perform the hysterectomy has informed the individual and her representative, if any, orally and in writing, that the hysterectomy will make the individual permanently incapable of reproducing; and
(2) The individual or her representative, if any, has signed a written acknowledgment of receipt of that information.
(d) Effective on March 8, 1979 or any date thereafter through the date of publication of these regulations at the option of the State, FFP is available if—
(1) The individual—
(i) Was already sterile before the hysterectomy; or
(ii) Requires a hysterectomy because of a life-threatening emergency situation in which the physician determines that prior acknowledgment is not possible; and
(2) The physician who performs the hysterectomy—
(i) Certifies in writing that the individual was already sterile at the time of the hysterectomy, and states the cause of the sterility; or
(ii) Certifies in writing that the hysterectomy was performed under a life-threatening emergency situation in which he or she determined prior acknowledgment was not possible. He or she must also include a description of the nature of the emergency.
(e) Effective March 8, 1979, or any date thereafter through the date of publication of these regulations at the option of the State, FFP is available for hysterectomies performed during a period of an individual's retroactive Medicaid eligibility if the physician who performed the hysterectomy certifies in writing that—
(1) The individual was informed before the operation that the hysterectomy would make her permanently incapable of reproducing; or
(2) One of the conditions in paragraph (d)(1) of this section was met. The physician must supply the information specified in paragraph (d)(2) of this section.
(a) FFP is not available in expenditures for any sterilization or hysterectomy unless the Medicaid agency, before making payment, obtained documentation showing that the requirements of this subpart were met. This documentation must include a consent from, an acknowledgement of receipt of hysterectomy information or a physician's certification under § 441.255(d)(2), as applicable.
(b) With regard to the requirements of § 441.255(d) for hysterectomies performed from March 8, 1979 through November 2, 1982, FFP is available in expenditures for those services if the documentation showing that the requirements of that paragraph were met is obtained by the Medicaid agency before submitting a claim for FFP for that procedure.
(a)
(1) The person who obtained consent for the sterilization procedure offered to answer any questions the individual to be sterilized may have concerning the procedure, provided a copy of the consent form and provided orally all of the following information or advice to the individual to be sterilized:
(i) Advice that the individual is free to withhold or withdraw consent to the procedure at any time before the sterilization without affecting the right to future care or treatment and without loss or withdrawal of any federally funded program benefits to which the individual might be otherwise entitled.
(ii) A description of available alternative methods of family planning and birth control.
(iii) Advice that the sterilization procedure is considered to be irreversible.
(iv) A thorough explanation of the specific sterilization procedure to be performed.
(v) A full description of the discomforts and risks that may accompany or follow the performing of the procedure, including an explanation of the type and possible effects of any anesthetic to be used.
(vi) A full description of the benefits or advantages that may be expected as a result of the sterilization.
(vii) Advice that the sterilization will not be performed for at least 30 days, except under the circumstances specified in § 441.253(c).
(2) Suitable arrangements were made to insure that the information specified in paragraph (a)(1) of this section was effectively communicated to any individual who is blind, deaf, or otherwise handicapped;
(3) An interpreter was provided if the individual to be sterilized did not understand the language used on the consent form or the language used by the person obtaining consent;
(4) The individual to be sterilized was permitted to have a witness of his or her choice present when consent was obtained;
(5) The consent form requirements of § 441.258 were met; and
(6) Any additional requirement of State or local law for obtaining consent, except a requirement for spousal consent, was followed.
(b)
(1) In labor or childbirth;
(2) Seeking to obtain or obtaining an abortion; or
(3) Under the influence of alcohol or other substances that affect the individual's state of awareness.
(a)
(b)
(1) The individual to be sterilized;
(2) The interpreter, if one was provided;
(3) The person who obtained the consent; and
(4) The physician who performed the sterilization procedure.
(c)
(i) Before the individual to be sterilized signed the consent form, he or she advised the individual to be sterilized that no Federal benefits may be withdrawn because of the decision not to be sterilized;
(ii) He or she explained orally the requirements for informed consent as set forth on the consent form; and
(iii) To the best of his or her knowledge and belief, the individual to be sterilized appeared mentally competent and knowingly and voluntarily consented to be sterilized.
(2) The physician performing the sterilization must certify, by signing the consent form, that:
(i) Shortly before the performance of sterilization, he or she advised the individual to be sterilized that no Federal benefits may be withdrawn because of the decision not to be sterilized;
(ii) He or she explained orally the requirements for informed consent as set forth on the consent form; and
(iii) To the best of his or her knowledge and belief, the individual appeared mentally competent and knowingly and voluntarily consented to be sterilized.
(3) In the case of premature delivery or emergency abdominal surgery performed within 30 days of consent, the physician must certify that the sterilization was performed less than 30 days, but not less than 72 hours after informed consent was obtained because of premature delivery or emergency abdominal surgery and—
(i) In the case of premature delivery, must state the expected date of delivery; or
(ii) In the case of abdominal surgery, must describe the emergency.
(4) If an interpreter is provided, the interpreter must certify that he or she translated the information and advice presented orally and read the consent form and explained its contents to the individual to be sterilized and that, to the best of the interpreter's knowledge and belief, the individual understood what the interpreter told him or her.
The Secretary will request public comment on the operation of this subpart not later than 3 years after its effective date.
I have asked for and received information about sterilization from (doctor or clinic). When I first asked for the information, I was told that the decision to be sterilized is completely up to me. I was told that I could decide not to be sterilized. If I decide not to be sterilized, my decision will not affect my right to future care or treatment. I will not lose any help or benefits from programs receiving Federal funds, such as A.F.D.C. or Medicaid that I am now getting or for which I may become eligible.
I understand that the sterilization must be considered permanent and not reversible. I have decided that I do not want to become pregnant, bear children or father children.
I was told about those temporary methods of birth control that are available and could be provided to me which will allow me to bear or father a child in the future. I have rejected these alternatives and chosen to be sterilized.
I understand that I will be sterilized by an operation known as a ______. The discomforts, risks and benefits associated with the operation have been explained to me. All my questions have been answered to my satisfaction.
I understand that the operation will not be done until at least 30 days after I sign this form. I understand that I can change my mind at any time and that my decision at any time not to be sterilized will not result in the withholding of any benefits or medical services provided by Federally funded programs.
I am at least 21 years of age and was born on (Day) (Month) (Year).
I, ______, hereby consent of my own free will to be sterilized by ______ by a method called ______. My consent expires 180 days from the date of my signature below.
I also consent to the release of this form and other medical records about the operation to:
Representatives of the Department of Health and Human Services or
Employees of programs or projects funded by that Department but only for determining if Federal laws were observed.
I have received a copy of this form. (Signature) (Date) (Month) (Day) (Year).
You are requested to supply the following information, but it is not required: (Race and ethnicity designation (please check)) Black (not of Hispanic origin); Hispanic; Asian or Pacific Islander; American Indian or Alaskan native; or White (not of Hispanic origin).
If an interpreter is provided to assist the individual to be sterilized:
I have translated the information and advice presented orally to the individual to be sterilized by the person obtaining this consent. I have also read him/her the consent form in ______ ______ language and explained its contents to him/her. To the best of my knowledge and belief he/she understood this explanation. (Interpreter) (Date).
Before (name of individual) signed the consent form, I explained to him/her the nature of the sterilization operation ______, the fact that it is intended to be a final and irreversible procedure and the discomforts, risks and benefits associated with it.
I counseled the individual to be sterilized that alternative methods of birth control are available which are temporary. I explained that sterilization is different because it is permanent.
I informed the individual to be sterilized that his/her consent can be withdrawn at any time and that he/she will not lose any health services or any benefits provided by Federal funds.
To the best of my knowledge and belief the individual to be sterilized is at least 21 years old and appears mentally competent. He/She knowingly and voluntarily requested to be sterilized and appears to understand the nature and consequence of the procedure. (Signature of person obtaining consent) (Date) (Facility) (Address).
Shortly before I performed a sterilization operation upon (Name of individual to be sterilized) on (Date of sterilization) (operation), I explained to him/her the nature of the sterilization operation (specify type of operation), the fact that it is intended to be a final and irreversible procedure and the discomforts, risks and benefits associated with it.
I counseled the individual to be sterilized that alternative methods of birth control are available which are temporary. I explained that sterilization is different because it is permanent.
I informed the individual to be sterilized that his/her consent can be withdrawn at any time and that he/she will not lose any health services or benefits provided by Federal funds.
To the best of my knowledge and belief the individual to be sterilized is at least 21 years old and appears mentally competent. He/She knowingly and voluntarily requested to be sterilized and appeared to understand the nature and consequences of the procedure.
(
(1) At least 30 days have passed between the date of the individual's signature on this consent form and the date the sterilization was performed.
(2) This sterilization was performed less than 30 days but more than 72 hours after the date of the individual's signature on this consent form because of the following circumstances (check applicable box and fill in information requested): Premature delivery.
Individual's expected date of delivery: ______
☐Emergency abdominal surgery: (describe circumstances):______ (Physician) (Date).
Section 1915(c) of the Act permits States to offer, under a waiver of statutory requirements, an array of home and community-based services that an individual needs to avoid institutionalization. Those services are defined in § 440.180 of this subchapter. This subpart describes what the Medicaid agency must do to obtain a waiver.
(a) A request for a waiver under this section must consist of the following:
(1) The assurances required by § 441.302 and the supporting documentation required by § 441.303.
(2) When applicable, requests for waivers of the requirements of section 1902(a)(1), section 1902(a)(10)(B), or section 1902(a)(10)(C)(i)(III) of the Act, which concern respectively, statewide application of Medicaid, comparability of services, and income and resource rules applicable to medically needy individuals living in the community.
(3) A statement explaining whether the agency will refuse to offer home or
(i) A hospital (as defined in § 440.10 of this chapter);
(ii) A NF (as defined in section 1919(a) of the Act); or
(iii) An ICF/MR (as defined in § 440.150 of this chapter), if applicable.
(b) If the agency furnishes home and community-based services, as defined in § 440.180 of this subchapter, under a waiver granted under this subpart, the waiver request must—
(1) Provide that the services are furnished—
(i) Under a written plan of care subject to approval by the Medicaid agency;
(ii) Only to recipients who are not inpatients of a hospital, NF, or ICF/MR; and
(iii) Only to recipients who the agency determines would, in the absence of these services, require the Medicaid covered level of care provided in—
(A) A hospital (as defined in § 440.10 of this chapter);
(B) A NF (as defined in section 1919(a) of the Act); or
(C) An ICF/MR (as defined in § 440.150 of this chapter);
(2) Describe the qualifications of the individual or individuals who will be responsible for developing the individual plan of care;
(3) Describe the group or groups of individuals to whom the services will be offered;
(4) Describe the services to be furnished so that each service is separately defined. Multiple services that are generally considered to be separate services may not be consolidated under a single definition. Commonly accepted terms must be used to describe the service and definitions may not be open ended in scope. CMS will, however, allow combined service definitions (bundling) when this will permit more efficient delivery of services and not compromise either a recipient's access to or free choice of providers.
(5) Provide that the documentation requirements regarding individual evaluation, specified in § 441.303(c), will be met; and
(6) Be limited to one of the following target groups or any subgroup thereof that the State may define:
(i) Aged or disabled, or both.
(ii) Mentally retarded or developmentally disabled, or both.
(iii) Mentally ill.
Unless the Medicaid agency provides the following satisfactory assurances to CMS, CMS will not grant a waiver under this subpart and may terminate a waiver already granted:
(a)
(1) Adequate standards for all types of providers that provide services under the waiver;
(2) Assurance that the standards of any State licensure or certification requirements are met for services or for individuals furnishing services that are provided under the waiver; and
(3) Assurance that all facilities covered by section 1616(e) of the Act, in which home and community-based services will be provided, are in compliance with applicable State standards that meet the requirements of 45 CFR Part 1397 for board and care facilities.
(b)
(c)
(1)
(i) If the recipient requires the level of care provided in a hospital as defined in § 440.10 of this subchapter, a NF as defined in section 1919(a) of the Act, or an ICF/MR as defined by § 440.150 of this subchapter; and
(ii) That the recipient, but for the provision of waiver services, would otherwise be institutionalized in such a facility.
(2)
(i) A hospital;
(ii) A NF; or
(iii) An ICF/MR.
(d)
(1) Informed of any feasible alternatives available under the waiver; and
(2) Given the choice of either institutional or home and community-based services.
(e)
(1) These expenditures must be reasonably estimated and documented by the agency.
(2) The estimate must be on an annual basis and must cover each year of the waiver period.
(f)
(1) A hospital;
(2) A NF; or
(3) An ICF/MR.
(g)
(h)
(1) The type, amount, and cost of services provided under the State plan; and
(2) The health and welfare of recipients.
(i)
(1) Not otherwise available to the individual through a local educational agency under section 602 (16) and (17) of the Education of the Handicapped Act (20 U.S.C. 1401 (16 and 17)) or as services under section 110 of the Rehabilitation Act of 1973 (29 U.S.C. 730); and
(2) Furnished as part of expanded habilitation services, if the State has requested and received CMS's approval under a waiver or an amendment to a waiver.
(j)
(1) Age 22 to 64;
(2) Age 65 and older and the State has not included the optional Medicaid benefit cited in § 440.140; or
(3) Age 21 and under and the State has not included the optional Medicaid benefit cited in § 440.160.
The agency must furnish CMS with sufficient information to support the assurances required by § 441.302. Except as CMS may otherwise specify for particular waivers, the information must consist of the following:
(a) A description of the safeguards necessary to protect the health and welfare of recipients. This information must include a copy of the standards established by the State for facilities that are covered by section 1616(e) of the Act.
(b) A description of the records and information that will be maintained to support financial accountability.
(c) A description of the agency's plan for the evaluation and reevaluation of recipients, including—
(1) A description of who will make these evaluations and how they will be made;
(2) A copy of the evaluation form to be used; and if it differs from the form used in placing recipients in hospitals, NFs, or ICFs/MR, a description of how and why it differs and an assurance that the outcome of the new evaluation form is reliable, valid, and fully comparable to the form used for hospital, NF, or ICF/MR placement;
(3) The agency's procedure to ensure the maintenance of written documentation on all evaluations and reevaluations; and
(4) The agency's procedure to ensure reevaluations of need at regular intervals.
(d) A description of the agency's plan for informing eligible recipients of the feasible alternatives available under the waiver and allowing recipients to choose either institutional services or home and community-based services.
(e) An explanation of how the agency will apply the applicable provisions regarding the post-eligibility treatment of income and resources of those individuals receiving home and community-based services who are eligible under a special income level (included in § 435.217 of this chapter).
(f) An explanation with supporting documentation satisfactory to CMS of how the agency estimated the average per capita expenditures for services.
(1) The annual average per capita expenditure estimate of the cost of home and community-based and other Medicaid services under the waiver must not exceed the estimated annual average per capita expenditures of the cost of services in the absence of a waiver. The estimates are to be based on the following equation:
(2) For purposes of the equation, the prime factors include the average per capita cost for all State plan services and expanded EPSDT services provided that are not accounted for in other formula values.
(3) In making estimates of average per capita expenditures for a waiver that applies only to individuals with a particular illness (for example, acquired immune deficiency syndrome) or condition (for example, chronic mental illness) who are inpatients in or who would require the level of care provided in hospitals as defined by § 440.10,
(4) In making estimates of average per capita expenditures for a separate waiver program that applies only to individuals identified through the preadmission screening annual resident review (PASARR) process who are developmentally disabled, inpatients of a NF, and require the level of care provided in an ICF/MR as determined by the State on the basis of an evaluation under § 441.303(c), the agency may determine the average per capita expenditures that would have been made in a fiscal year for those individuals based on the average per capita expenditures for inpatients in an ICF/MR. When submitting estimates of institutional costs without the waiver, the agency may use the average per capita costs of ICF/MR care even though the deinstitutionalized developmentally disabled were inpatients of NFs.
(5) For persons diverted rather than deinstitutionalized, the State's evaluation process required by § 441.303(c) must provide for a more detailed description of their evaluation and screening procedures for recipients to ensure that waiver services will be limited to persons who would otherwise receive the level of care provided in a hospital, NF, or ICF/MR, as applicable.
(6) The State must indicate the number of unduplicated beneficiaries to which it intends to provide waiver services in each year of its program. This number will constitute a limit on the size of the waiver program unless the State requests and the Secretary approves a greater number of waiver participants in a waiver amendment.
(7) In determining the average per capita expenditures that would have been made in a waiver year, for waiver estimates that apply to persons with mental retardation or related conditions, the agency may include costs of Medicaid residents in ICFs/MR that have been terminated on or after November 5, 1990.
(8) In submitting estimates for waivers that include personal caregivers as a waiver service, the agency may include a portion of the rent and food attributed to the unrelated personal caregiver who resides in the home or residence of the recipient covered under the waiver. The agency must submit to CMS for review and approval the method it uses to apportion the costs of rent and food. The method must be explained fully to CMS. A personal caregiver provides a waiver service to meet the recipient's physical, social, or emotional needs (as opposed to services not directly related to the care of the recipient; that is, housekeeping or chore services). FFP for live-in caregivers is not available if the recipient lives in the caregiver's home or in a residence that is owned or leased by the caregiver.
(9) In submitting estimates for waivers that apply to individuals with mental retardation or a related condition, the agency may adjust its estimate of average per capita expenditures to include increases in expenditures for ICF/MR care resulting from implementation of a PASARR program for making determinations for individuals with mental retardation or related conditions on or after January 1, 1989.
(10) For a State that has CMS approval to bundle waiver services, the State must continue to compute separately the costs and utilization of the component services that make up the bundled service to support the final cost and utilization of the bundled service that will be used in the cost-neutrality formula.
(g) The State, at its option, may provide for an independent assessment of its waiver that evaluates the quality of care provided, access to care, and cost-neutrality. The results of the assessment should be submitted to CMS at least 90 days prior to the expiration date of the approved waiver-period and cover the first 24 or 48 months of the waiver. If a State chooses to provide for an independent assessment, FFP is available for the costs attributable to the independent assessment.
(h) For States offering habilitation services that include prevocational, educational, or supported employment services, or a combination of these services, consistent with the provisions
(i) For States offering home and community-based services for individuals diagnosed as chronically mentally ill, an explanation of why these individuals would not be placed in an institution for mental diseases (IMD) absent the waiver, and the age group of these individuals.
(a) The effective date for a new waiver of Medicaid requirements to provide home and community-based services approved under this subpart is established by CMS prospectively on or after the date of approval and after consultation with the State agency. The initial approved waiver continues for a 3-year period from the effective date. If the agency requests it, the waiver may be extended for additional periods unless—
(1) CMS's review of the prior waiver period shows that the assurances required by § 441.302 were not met; and
(2) CMS is not satisfied with the assurances and documentation provided by the State in regard to the extension period.
(b) CMS will determine whether a request for extension of an existing waiver is actually an extension request or a request for a new waiver. If a State submits an extension request that would add a new group to the existing group of recipients covered under the waiver (as defined under § 441.301(b)(6)), CMS will consider it to be two requests: One as an extension request for the existing group, and the other as a new waiver request for the new group. Waivers may be extended for additional 5-year periods.
(c) CMS
(d) If CMS finds that an agency is not meeting one or more of the requirements for a waiver contained in this subpart, the agency is given a notice of CMS's findings and an opportunity for a hearing to rebut the findings. If CMS determines that the agency is not in compliance with this subpart after the notice and any hearing, CMS may terminate the waiver. For example, a State submits to CMS a waiver request for home and community-based services that includes an estimate of the expenditures that would be incurred if the services were provided to the covered individuals in a hospital, NF, or ICF/MR in the absence of the waiver. CMS approves the waiver. At the end of the waiver year, the State submits to CMS a report of its actual expenditures under the waiver. CMS finds that the actual expenditures under the waiver exceed 100 percent of the State's approved estimate of expenditures for these individuals in a hospital, NF, or ICF/MR in the absence of the waiver. CMS next requires the State to amend its estimates for subsequent waiver year(s). CMS then compares the revised estimates with the State's actual experience to determine if the revised estimates are reasonable. CMS may terminate the waiver if the revised estimates indicate that the waiver is not cost-neutral or that the revised estimates are unreasonable.
(a)
(b)
(2) The agency may replace any individuals who die or become ineligible for State plan services to maintain a count up to the number specified by the State and approved by CMS within the 200-maximum limit.
Whenever appropriate, the State agency administering the plan under Medicaid may enter into cooperative arrangements with the State agency responsible for administering a program for children with special health care needs under the Maternal and Child Health program (Title V of the Act) in order to ensure improved access to coordinated services to meet the children's needs.
(a) If a State chooses to terminate its waiver before the initial 3-year period or 5-year renewal period expires, it must notify CMS in writing 30 days before terminating services to recipients.
(b) If CMS or the State terminates the waiver, the State must notify recipients of services under the waiver in accordance with § 431.210 of this subchapter and notify them 30 days before terminating services.
The procedures specified in subpart D of part 430 of this chapter are applicable to State requests for hearings on terminations.
(a) FFP for home and community-based services listed in § 440.180 of this chapter is not available in expenditures for the following:
(1) Services provided in a facility subject to the health and welfare requirements described in § 441.302(a) during any period in which the facility is found not to be in compliance with the applicable State standards described in that section.
(2) The cost of room and board except when provided as—
(i) Part of respite care services in a facility approved by the State that is not a private residence; or
(ii) For waivers that allow personal caregivers as providers of approved waiver services, a portion of the rent and food that may be reasonably attributed to the unrelated caregiver who resides in the same household with the waiver recipient. FFP for a live-in caregiver is not available if the recipient lives in the caregiver's home or in a residence that is owned or leased by the provider of Medicaid services (the caregiver). For purposes of this provision, “board” means 3 meals a day or any other full nutritional regimen and does not include meals provided as part of a program of adult day health services as long as the meals provided do not constitute a “full” nutritional regimen.
(3) Prevocational, educational, or supported employment services, or any combination of these services, as part of habilitation services that are—
(i) Provided in approved waivers that include a definition of “habilitation services” but which have not included prevocational, educational, and supported employment services in that definition; or
(ii) Otherwise available to the recipient under either special education and related services as defined in section 602(16) and (17) of the Education of the Handicapped Act (20 U.S.C. 1401(16) and (17)) or vocational rehabilitation services available to the individual through a program funded under section 110 of the Rehabilitation Act of 1973 (29 U.S.C. 730).
(4) For waiver applications and renewals approved on or after October 21,
(b) FFP is available for expenditures for expanded habilitation services, as described in § 440.180 of this chapter, if the services are included under a waiver or waiver amendment approved by CMS.
Section 1915(d) of the Act permits States to offer, under a waiver of statutory requirements, home and community-based services not otherwise available under Medicaid to individuals age 65 or older, in exchange for accepting an aggregate limit on the amount of expenditures for which they claim FFP for certain services furnished to these individuals. The home and community-based services that may be furnished are listed in § 440.181 of this subchapter. This subpart describes the procedures the Medicaid agency must follow to request a waiver.
A request for a waiver under this section must meet the following requirements:
(a)
(b)
(c)
(d)
(e)
(1) Are age 65 or older;
(2) Are not inpatients of a hospital, NF, or ICF/MR; and
(3) The agency determines would be likely to require the care furnished in a NF under Medicaid.
(f)
(g)
(h)
(i)
At 57 FR 29156, June 30, 1992, § 441.351 was added. This section contains information collection and recordkeeping requirements and will not become effective until approval has been given by the Office of Management and Budget.
Unless the Medicaid agency provides the following satisfactory assurances to CMS, CMS will not grant a waiver under this subpart and may terminate a waiver already granted.
(a)
(1) Adequate standards for all types of providers that furnish services under the waiver are met. (These standards must be reasonably related to the requirements of the waiver service to be furnished.)
(2) The standards of any State licensure or certification requirements are met for services or for individuals furnishing services under the waiver.
(3) All facilities covered by section 1616(e) of the Act, in which home and community-based services are furnished, are in compliance with applicable State standards that meet the requirements of 45 CFR part 1397 for board and care facilities.
(4) Physician reviews of prescribed psychotropic drugs (when prescribed for purposes of behavior control of waiver recipients) occur at least every 30 days.
(b)
(c)
(d)
(e)
(1) The type, amount, and cost of services furnished under the State plan; and
(2) The health and welfare of recipients of the services described in § 440.181 of this chapter.
At 57 FR 29156, June 30, 1992, § 441.352 was added. This section contains information collection and recordkeeping requirements and will not become effective until approval has been given by the Office of Management and Budget.
The agency must furnish CMS with sufficient information to support the assurances required under § 441.352, in order to meet the requirement that the assurances are satisfactory. At a minimum, this information must consist of the following:
(a)
This information must include:
(1) A copy of the standards established by the State for facilities (in which services will be furnished) that are covered by section 1616(e) of the Act.
(2) The minimum educational or professional qualifications of the providers of the services.
(3) A description of the administrative oversight mechanisms established by the State to ensure quality of care.
(b)
(c)
(1) A description of who makes these evaluations and how they are made.
(2) A copy of the evaluation instrument.
(3) The agency's procedure to assure the maintenance of written documentation on all evaluations and reevaluations and copies of the forms. In accordance with regulations at 45 CFR part 74, written documentation of all evaluations and reevaluations must be maintained for a minimum period of 3 years.
(4) The agency's procedure to assure reevaluations of need at regular intervals.
(5) The intervals at which reevaluations occur, which may be no less frequent than for institutionalized individuals at comparable levels of care.
(6) The procedures and criteria used for evaluation and reevaluation of waiver recipients must be the same or more stringent than those used for individuals served in NFs.
(d)
(e)
At 57 FR 29156, June 30, 1992, § 441.353 was added. This section contains information collection and recordkeeping requirements and will not become effective until approval has been given by the Office of Management and Budget.
(a)
(1) Federal fiscal year (FFY) 1987 (that is, October 1, 1986 through September 30, 1987); or
(2) In the case of a State which did not report expenditures on the basis of age categories during FFY 1987, the base year means FFY 1989 (that is, October 1, 1988 through September 30, 1989).
(b)
(2) In applying for a waiver under this subpart, the agency must clearly identify the base year it intends to use.
(3) The State may make a preliminary calculation of the expenditure limit at the time of the waiver approval; however, CMS makes final calculations of the aggregate limit after base data have been verified and accepted.
(4) All base year and waiver year data are subject to final cost settlement within 2 years from the end of the base or waiver year involved.
(c)
(d)
(a)
(2) The initial waiver is approved for a 3-year period from the effective date. Subsequent renewals are approved for 5-year periods.
(3) If the agency requests it, the waiver may be extended for an additional 5-year period if CMS's review of the prior period shows that the assurances required by § 441.352 were met.
(4) The agency may request that waiver modifications be made effective retroactive to the first day of the waiver year in which the amendment is submitted, unless the amendment involves substantive change. Substantive changes may include, but are not limited to, addition of services under the waiver, a change in the qualifications of service providers, or a change in the eligible population.
(5) A request for an amendment that involves a substantive change is given a prospective effective date, but this date need not coincide with the start of the next FFY.
(b)
(c)
(d)
(1) The existing waiver remains in effect for a period of not less than 90 days after the date on which CMS denies the request, or, if the State seeks reconsideration in accordance with § 441.357, the date on which a final determination is made with respect to that review.
(2) CMS calculates an APEL for the period for which the waiver remains in effect, and this calculation is used to
(a)
(1) The State must notify CMS in writing at least 30 days before terminating services to recipients.
(2) The State must notify recipients of services under the waiver at least 30 days before terminating services in accordance with § 431.210 of this chapter.
(3) CMS continues to apply the APEL described in § 441.354 through the end of the waiver year, but this limit is not applied in subsequent years.
(4) The State may not decrease the services available under the approved State plan to individuals age 65 or older by an amount that violates the comparability of service requirements set forth in § 440.240 of this chapter.
(b)
(2) If CMS terminates the waiver, the following conditions apply:
(i) The State must notify recipients of services under the waiver at least 30 days before terminating services in accordance with § 431.210 of this chapter.
(ii) CMS continues to apply the APEL in § 441.354 of this subpart, but the limit is prorated according to the number of days in the fiscal year during which waiver services were offered. The limit expires concurrently with the termination of home and community-based services under the waiver.
At 57 FR 29156, June 30, 1992, § 441.356 was added. This section contains information collection and recordkeeping requirements and will not become effective until approval has been given by the Office of Management and Budget.
The procedures specified in § 430.18 of this subchapter apply to State requests for hearings on denials, renewals, or amendments of waivers for home and community-based services for individuals age 65 or older.
FFP for home and community-based services listed in § 440.181 of this subchapter is not available in expenditures for the following:
(a) Services furnished in a facility subject to the health and welfare requirements described in § 441.352(a) during any period in which the facility is found not to be in compliance with the applicable State requirements described in that section.
(b) The cost of room and board except when furnished as part of respite care services in a facility, approved by the State, that is not a private residence. For purposes of this subpart, “board” means three meals a day or any other full nutritional regimen. “Board” does not include meals, which do not comprise a full nutritional regimen, furnished as part of adult day health services.
(c) The portion of the cost of room and board attributed to unrelated, live-in personal caregivers when the waiver recipient lives in the caregiver's home or a residence owned or leased by the provider of the Medicaid services (the caregiver).
(d) Services that are not included in the approved State plan and not approved as waiver services by CMS.
(e) Services furnished to recipients who are ineligible under the terms of the approved waiver.
(f) Services furnished by a provider when either the services or the provider do not meet the standards that are set by the State and included in the approved waiver.
(g) Services furnished to a recipient by his or her spouse.
(a)
(b)
(2) Each review team must consist of at least one physician or registered nurse, and at least one other individual with health and social service credentials who the State believes is qualified to properly evaluate and assess the care and services provided under the waiver. If there is no physician on the review team, the Medicaid agency must ensure that a physician is available to provide consultation to the review team.
(3) For waiver services furnished to individuals who have been found to be likely to require the level of care furnished in a NF that is also an IMD, each review team must have a psychiatrist or physician and other appropriate mental health or social service personnel who are knowledgeable about geriatric mental illness.
(c)
(2) No physician member of a review team may evaluate or assess the care of a recipient for whom he or she is the attending physician.
(3) No individual who serves as case manager, caseworker, benefit authorizer, or any similar position, may serve as member of a review team that evaluates and assesses care furnished to a recipient with whom he or she has had a professional relationship.
(d)
(e)
(f)
(g)
(i) A review of each recipient's medical record, the evaluation and reevaluation required by § 441.353(c), and the plan of care under which the waiver and other services are furnished; and
(ii) If the records described in paragraph (g)(1)(i) of this section are inadequate or incomplete, personal contact and observation of each recipient.
(2) The review team may personally contact and observe any recipient whose care the team evaluates and assesses.
(3) The review team may consult with both formal and informal caregivers when the recipient's records are inadequate or incomplete and when any apparent discrepancy exists between services required by the recipient and services furnished under the waiver.
(h)
(1) The services included in the plan of care are adequate to meet the health and welfare needs of each recipient;
(2) The services included in the plan of care have been furnished to the recipient as planned;
(3) It is necessary and in the interest of the recipient to continue receiving services through the waiver program; and
(4) It is feasible to meet the recipient's health and welfare needs through the waiver program.
(i)
(1) Whether the medical record, the determination of level of care, and the plan of care are consistent, and whether all ordered services have been furnished and properly recorded.
(2) Whether physician review of prescribed psychotropic medications (when required for behavior control) has occurred at least every 30 days.
(3) Whether tests or observations of each recipient indicated by his or her medical record are made at appropriate times and properly recorded.
(4) Whether progress notes entered in the record by formal and informal caregivers are made as required and appear to be consistent with the observed condition of the recipient.
(5) Whether reevaluations of the recipient's level of care have occurred at least as frequently as would be required if that individual were served in a NF.
(6) Whether the recipient receives adequate care and services, based, at a minimum, on the following when observations are necessary (the requirements for the necessity of observations are set forth in new § 441.365(g)(3)):
(i) Cleanliness.
(ii) Absence of bedsores.
(iii) Absence of signs of malnutrition or dehydration.
(7) Whether the recipient needs any service that is not included in the plan of care, or if included, is not being furnished by formal or informal caregivers under the waiver or through arrangements with another public or private source of assistance.
(8) Determination as to whether continued home and community-based services are required by the recipient to avoid the likelihood of placement in a NF.
(j)
(1) Within 1 month of the completion of the review.
(2) Immediately upon its determination that conditions exist that may constitute a threat to the life or health of a recipient.
(k)
At 57 FR 29156, June 30, 1992, § 441.365 was added. This section contains information collection and recordkeeping requirements and will not become effective until approval has been given by the Office of Management and Budget.
This subpart implements section 1905(a)(24) of the Act, which adds community supported living arrangements services to the list of services that States may provide as medical assistance under title XIX (to the extent and as defined in section 1930 of the Act), and section 1930(h)(1)(B) of the Act, which specifies minimum protection requirements that a State which provides community supported living arrangements services as an optional Medicaid service to developmentally disabled individuals must meet to ensure the health, safety and welfare of those individuals.
If a State that is eligible to provide community supported living arrangements services as an optional Medicaid service to developmentally disabled individuals provides such services, the State plan must specify that it complies with the minimum protection requirements in § 441.404.
To be eligible to provide community supported living arrangements services to developmentally disabled individuals, a State must assure, through methods other than reliance on State licensure processes or the State quality assurance programs described under section 1930(d) of the Act, that:
(a) Individuals receiving community supported living arrangements services are protected from neglect, physical and sexual abuse, and financial exploitation;
(b) Providers of community supported living arrangements services—
(1) Do not use individuals who have been convicted of child or client abuse, neglect, or mistreatment, or of a felony involving physical harm to an individual; and
(2) Take all reasonable steps to determine whether applicants for employment by the provider have histories indicating involvement in child or client abuse, neglect, or mistreatment, or a criminal record involving physical harm to an individual;
(c) Providers of community supported living arrangements services are not unjustly enriched as a result of abusive financial arrangements (such as owner lease-backs) with developmentally disabled clients; and
(d) Providers of community supported living arrangements services, or the relatives of such providers, are not named beneficiaries of life insurance policies purchased by or on behalf of developmentally disabled clients.
(a)
(b)
(1) The purchase of PAS and supports for PAS.
(2) Recruiting workers.
(3) Hiring and discharging workers.
(4) Training workers and accessing training provided by or through the State if additional worker training is required or desired by the participant, or participant's representative, if applicable.
(5) Specifying worker qualifications.
(6) Determining worker duties.
(7) Scheduling workers.
(8) Supervising workers.
(9) Evaluating worker performance.
(10) Determining the amount paid for a service, support or item.
(11) Scheduling when services are provided.
(12) Identifying service workers.
(13) Reviewing and approving invoices.
(c)
(1) Is sufficiently individualized to address each participant's critical contingencies or incidents that would pose a risk of harm to the participant's health or welfare;
(2) Must demonstrate an interface with the risk management provision at § 441.476 which requires States to assess and identify the potential risks to the participant (such as any critical health needs), and ensure that the risks and how they will be managed are the result of discussion and negotiation among the persons involved in the service plan development;
(3) Must not include the 911 emergency system or other emergency system as the sole backup feature of the plan; and
(4) Must be incorporated into the participant's service plan.
(1) The parent (biological or adoptive) of a minor child or the guardian of a minor child who must provide care to the child.
(2) Legally-assigned caretaker relatives.
(3) A spouse.
(1) An understanding of the philosophy of self-direction and person-centered and directed planning;
(2) The ability to facilitate participants' independence and participants' preferences in managing PAS and budgets, including any risks assumed by participants;
(3) The ability to develop service budgets and ensure appropriate documentation; and
(4) Knowledge of the PAS and resources available in the participant's community and how to access them.
The availability of a supports broker or consultant to each participant is a requirement of the support system.
(a) States must have in place, before electing the self-directed PAS option, personal care services through the State plan, or home and community-based services under a section 1915(c) waiver.
(b) The State must have both traditional service delivery and the self-directed PAS service delivery option available in the event that an individual voluntarily disenrolls or is involuntarily disenrolled, from the self-directed PAS service delivery option.
(c) The State's assessment of an individual's needs must form the basis of the level of services for which the individual is eligible.
(d) Nothing in this subpart will be construed as affecting an individual's Medicaid eligibility, including that of an individual whose Medicaid eligibility is attained through receipt of section 1915(c) waiver services.
(a) States have the option of disbursing cash prospectively to participants, or their representatives, as applicable, self-directing their PAS.
(b) States that choose to offer the cash option must ensure compliance with all applicable requirements of the Internal Revenue Service, including, but not limited to, retaining required forms and payment of FICA, FUTA and State unemployment taxes.
(c) States must permit participants, or their representatives, as applicable, using the cash option to choose to use the financial management entity for some or all of the functions described in § 441.484(c).
(d) States must make available a financial management entity to a participant, or the participant's representative, if applicable, who has demonstrated, after additional counseling, information, training, or assistance, that the participant cannot effectively manage the cash option described in paragraph (a) of this section.
(a) States must permit a participant to voluntarily disenroll from the self-directed PAS option at any time and return to a traditional service delivery system.
(b) The State must specify in a section 1915(j) State plan amendment the safeguards that are in place to ensure continuity of services during the transition from self-directed PAS.
(a) States must specify the conditions under which a participant may be involuntarily disenrolled from the self-directed PAS option.
(b) CMS must approve the State's conditions under which a participant may be involuntarily disenrolled.
(c) The State must specify in the section 1915(j) State plan amendment the safeguards that are in place to ensure continuity of services during the transition from self-directed PAS.
(a) Self-directed PAS are not available to an individual who resides in a home or property that is owned, operated, or controlled by a PAS provider who is not related to the individual by blood or marriage.
(b) States may specify additional restrictions on a participant's living arrangements if they have been approved by CMS.
A State may do the following:
(a) Provide self-directed PAS without regard to the requirements of statewideness.
(b) Limit the population eligible to receive these services without regard to comparability of amount, duration, and scope of services.
(c) Limit the number of persons served without regard to comparability of amount, duration, and scope of services.
A State must assure that the following requirements are met:
(a)
(1) Safeguards must prevent the premature depletion of the participant directed budget as well as identify potential service delivery problems that might be associated with budget underutilization.
(2) These safeguards may include the following:
(i) Requiring a case manager, support broker or other person to monitor the participant's expenditures.
(ii) Requiring the financial management entity to flag significant budget variances (over and under expenditures) and bring them to the attention of the participant, the participant's representative, if applicable, case manager, or support broker.
(iii) Allocating the budget on a monthly or quarterly basis.
(iv) Other appropriate safeguards as determined by the State.
(3) Safeguards must be designed so that budget problems are identified on a timely basis so that corrective action may be taken, if necessary.
(b)
(1) Are entitled to medical assistance for personal care services under the State plan or receiving home and community based services under a section 1915(c) waiver program.
(2) May require self-directed PAS.
(3) May be eligible for self-directed PAS.
(c)
(1) Information about self-direction opportunities that is sufficient to inform decision-making about the election of self-direction and provided on a timely basis to an individual or the representative which minimally includes the following:
(i) Elements of self-direction compared to non-self-directed PAS.
(ii) Individual responsibilities and potential liabilities under the self-direction service delivery model.
(iii) The choice to receive PAS through a waiver program administered under section 1915(c) of the Act, regardless of delivery system, if applicable.
(iv) The option, if available, to receive and manage the cash amount of their individual budget allocation.
(2) When and how this information is provided.
(d)
(1) Appropriately assesses and counsels an individual, or the individual's representative, if applicable, before enrollment, including information about disenrollment.
(2) Provides appropriate information, counseling, training, and assistance to ensure that a participant is able to manage the services and budgets. Such information must be communicated to the participant in a manner and language understandable by the participant. The support activities must include at least the following:
(i) Person-centered planning and how it is applied.
(ii) Information about the services available for self-direction.
(iii) Range and scope of individual choices and options.
(iv) Process for changing the service plan and service budget.
(v) Grievance process.
(vi) Risks and responsibilities of self-direction.
(vii) The ability to freely choose from available PAS providers.
(viii) Individual rights.
(ix) Reassessment and review schedules.
(x) Defining goals, needs, and preferences.
(xi) Identifying and accessing services, supports, and resources.
(xii) Development of risk management agreements.
(xiii) Development of an individualized backup plan.
(xiv) Recognizing and reporting critical events.
(xv) Information about an advocate or advocacy systems available in the State and how a participant, or a participant's representative, if applicable, can access the advocate or advocacy systems.
(3) Offers additional information, counseling, training, or assistance, including financial management services under either of the following conditions:
(i) At the request of the participant, or participant's representative, if applicable, for any reason.
(ii) When the State has determined the participant, or participant's representative, if applicable, is not effectively managing the services identified in the service plan or budget.
(4) The State may mandate the use of additional assistance, including the use of a financial management entity, or may initiate an involuntary disenrollment in accordance with § 441.458, if, after additional information, counseling, training or assistance is provided to a participant (or participant's representative, if applicable), the participant (or participant's representative, if applicable) has continued to demonstrate an inability to effectively manage the services and budget.
(e)
(f)
States must conduct an assessment of the participant's needs, strengths, and preferences in accordance with the following:
(a) States may use one or more processes and techniques to obtain information about an individual, including health condition, personal goals and preferences for the provision of services, functional limitations, age, school, employment, household, and other factors that are relevant to the need for and authorization and provision of services.
(b) Assessment information supports the determination that an individual requires PAS and also supports the development of the service plan and budget.
(a) The service plan must include at least the following:
(1) The scope, amount, frequency, and duration of each service.
(2) The type of provider to furnish each service.
(3) Location of the service provision.
(4) The identification of risks that may pose harm to the participant along with a written individualized backup plan for mitigating those risks.
(b) A State must develop a service plan for each program participant using a person-centered and directed planning process to ensure the following:
(1) The identification of each program participant's preferences, choices, and abilities, and strategies to address those preferences, choices, and abilities.
(2) The option for the program participant, or participant's representative, if applicable, to exercise choice and
(3) Assessment of, and planning for avoiding, risks that may pose harm to a participant.
(c) All of the State's applicable policies and procedures associated with service plan development must be carried out and include, but are not limited to, the following:
(1) Allow the participant, or participant's representative, if applicable, the opportunity to engage in, and direct, the process to the extent desired.
(2) Allow the participant, or participant's representative, if applicable, the opportunity to involve family, friends, and professionals (as desired or required) in the development and implementation of the service plan.
(3) Ensure the planning process is timely.
(4) Ensure the participant's needs are assessed and that the services meet the participant's needs.
(5) Ensure the responsibilities for service plan development are identified.
(6) Ensure the qualifications of the individuals who are responsible for service plan development reflect the nature of the program's target population(s).
(7) Ensure the State reviews the service plan annually, or whenever necessary due to a change in the participant's needs or health status.
(8) Ensure that a participant may request revisions to a service plan, based on a change in needs or health status.
(d) When an entity that is permitted to provide other State plan services is responsible for service plan development, the State must describe the safeguards that are in place to ensure that the service provider's role in the planning process is fully disclosed to the participant, or participant's representative, if applicable, and controls are in place to avoid any possible conflict of interest.
(e) An approved self-directed service plan conveys authority to the participant, or participant's representative, if applicable, to perform, at a minimum, the following tasks:
(1) Recruit and hire workers to provide self-directed services, including specifying worker qualifications.
(2) Fire workers.
(3) Supervise workers in the provision of self-directed services.
(4) Manage workers in the provision of self-directed services, which includes the following functions:
(i) Determining worker duties.
(ii) Scheduling workers.
(iii) Training workers in assigned tasks.
(iv) Evaluating workers performance.
(5) Determine the amount paid for a service, support, or item.
(6) Review and approve provider invoices.
A service budget must be developed and approved by the State based on the assessment of need and service plan and must include the following:
(a) The specific dollar amount a participant may utilize for services and supports.
(b) How the participant is informed of the amount of the service budget before the service plan is finalized.
(c) The procedures for how the participant, or participant's representative, if applicable, may adjust the budget, including the following:
(1) How the participant, or participant's representative, if applicable, may freely make changes to the budget.
(2) The circumstances, if any, that may require prior approval before a budget adjustment is made.
(3) The circumstances, if any, that may require a change in the service plan.
(d) The procedure(s) that governs how a person, at the election of the State, may reserve funds to purchase items that increase independence or substitute for human assistance, to the extent that expenditures would otherwise be made for the human assistance, including additional goods, supports, services or supplies.
(e) The procedure(s) that governs how a person may use a discretionary amount, if applicable, to purchase items not otherwise delineated in the budget or reserved for permissible purchases.
(f) How participants, or their representative, if applicable, are afforded
(a) The State shall set forth a budget methodology that ensures service authorization resides with the State and meets the following criteria:
(1) The State's method of determining the budget allocation is objective and evidence based utilizing valid, reliable cost data.
(2) The State's method is applied consistently to participants.
(3) The State's method is open for public inspection.
(4) The State's method includes a calculation of the expected cost of the self-directed PAS and supports, if those services and supports were not self-directed.
(5) The State has a process in place that describes the following:
(i) Any limits it places on self-directed services and supports, and the basis for the limits.
(ii) Any adjustments that will be allowed and the basis for the adjustments.
(b) The State must have procedures to safeguard participants when the budgeted service amount is insufficient to meet a participant's needs.
(c) The State must have a method of notifying participants, or their representative, if applicable, of the amount of any limit that applies to a participant's self-directed PAS and supports.
(d) The budget may not restrict access to other medically necessary care and services furnished under the plan and approved by the State but not included in the budget.
(e) The State must have a procedure to adjust a budget when a reassessment indicates a change in a participant's medical condition, functional status or living situation.
(a) The State must provide a quality assurance and improvement plan that describes the State's system of how it will perform activities of discovery, remediation and quality improvement in order to learn of critical incidents or events that affect participants, correct shortcomings, and pursue opportunities for system improvement.
(b) The quality assurance and improvement plan shall also describe the system performance measures, outcome measures, and satisfaction measures that the State must use to monitor and evaluate the self-directed State plan option. Quality of care measures must be made available to CMS upon request and include indicators approved or prescribed by the Secretary.
(a) The State must specify the risk assessment methods it uses to identify potential risks to the participant.
(b) The State must specify any tools or instruments it uses to mitigate identified risks.
(c) The State must ensure that each service plan includes the risks that an individual is willing and able to assume, and the plan for how identified risks will be mitigated.
(d) The State must ensure that the risk management plan is the result of discussion and negotiation among the persons designated by the State to develop the service plan, the participant, the participant's representative, if any, and others from whom the participant may seek guidance.
(a) States have the option to permit participants, or their representatives, if applicable, to hire any individual capable of providing the assigned tasks, including legally liable relatives, as paid providers of the PAS identified in the service plan and budget.
(b) Participants, or their representatives, if applicable, retain the right to train their workers in the specific areas of personal assistance needed by the participant and to perform the needed assistance in a manner that comports with the participant's personal, cultural, and/or religious preferences. Participants, or their representatives, if applicable, also have
(c) Participants, or their representatives, if applicable, retain the right to establish additional staff qualifications based on participants' needs and preferences.
(a) States may permit participants to appoint a representative to direct the provision of self-directed PAS on their behalf. The following types of representatives are permissible:
(1) A minor child's parent or guardian.
(2) An individual recognized under State law to act on behalf of an incapacitated adult.
(3) A State-mandated representative, after approval by CMS of the State criteria, if the participant has demonstrated, after additional counseling, information, training or assistance, the inability to self-direct PAS.
(b) A person acting as a representative for a participant receiving self-directed PAS is prohibited from acting as a provider of self-directed PAS to the participant.
(a) Participants, or their representatives, if applicable, may, at the State's option, use their service budgets to pay for items that increase a participant's independence or substitute (such as a microwave oven or an accessibility ramp) for human assistance, to the extent that expenditures would otherwise be made for the human assistance.
(b) The services, supports and items that are purchased with a service budget must be linked to an assessed participant need or goal established in the service plan.
(a) States may choose to provide financial management services to participants, or their representatives, as applicable, self-directing PAS, with the exception of those participants utilizing the cash option who directly perform those functions, utilizing a financial management entity, through the following arrangements:
(1) States may use a reporting or subagent through its fiscal intermediary in accordance with section 3504 of the IRS Code and Revenue Procedure 80-4 and Notice 2003-70; or
(2) States may use a vendor organization that has the capabilities to perform the required tasks in accordance with Section 3504 of the IRS Code and Revenue Procedure 70-6. When private entities furnish financial management services, the procurement method must meet the requirements set forth in 45 CFR 74.40 through 74.48.
(b) States must provide oversight of financial management services by performing the following functions:
(1) Monitoring and assessing the performance of financial management entity, including assuring the integrity of financial transactions they perform.
(2) Designating a State entity or entities responsible for this monitoring.
(3) Determining how frequently financial management entity performance will be assessed.
(c) A financial management entity must provide functions including, but not limited to, the following:
(1) Collect and process timesheets of the participant's workers.
(2) Process payroll, withholding, filing and payment of applicable Federal, State and local employment-related taxes and insurance.
(3) Maintain a separate account for each participant's budget.
(4) Track and report disbursements and balances of participant funds.
(5) Process and pay invoices for goods and services approved in the service plan.
(6) Provide to participants periodic reports of expenditures and the status of the approved service budget.
(d) States not utilizing a financial management entity must perform the functions listed in paragraph (c) of this section on behalf of participants self-directing PAS, with the exception of those participants utilizing the cash option who directly perform those functions.
(e) States will be reimbursed for the cost of financial management services, either provided directly or through a
Sec. 1102 of the Social Security Act (42 U.S.C. 1302), unless otherwise noted.
(a) This part states requirements for provider agreements for facility certification relating to the provision of services furnished by nursing facilities and intermediate care facilities for the mentally retarded. This part is based on the following sections of the Act:
(b) Section 431.610 of this subchapter contains requirements for designating the State licensing agency to survey these facilities and for certain survey agency responsibilities.
In this part—
(a) Individuals who were in the facility before the effective date of denial of payment for new admissions, even if they become eligible for Medicaid after that date.
(b) If the approved State plan includes payments for reserved beds, individuals who, after a temporary absence from the facility, are readmitted to beds reserved for them in accordance with § 447.40(a) of this chapter.
A State plan must provide that requirements of this subpart are met.
(a)
(b)
(c)
(d)
(2) A provider agreement is not a valid agreement for purposes of this part even though certified by the State survey agency, if the facility fails to meet the civil rights requirements set forth in 45 CFR parts 80, 84, and 90.
The effective date of a provider agreement with an NF or ICF/MR is determined in accordance with the rules set forth in § 431.108.
(a)
(b)
(1) Any existing plan of correction.
(2) Any expiration date for ICFs/MR.
(3) Compliance with applicable health and safety requirements.
(4) Compliance with the ownership and financial interest disclosure requirements of §§ 455.104 and 455.105 of this chapter.
(5) Compliance with civil rights requirements set forth in 45 CFR parts 80, 84, and 90.
(6) Compliance with any additional requirements imposed by the Medicaid agency.
(a) Except as specified under § 442.16, the duration of an agreement may not exceed 12 months.
(b) The agreement must be for the same duration as the certification period set by the survey agency. However, if the Medicaid agency has adequate documentation showing good cause, it may make an agreement for less than this period.
(c) FFP is available for services provided by a facility for up to 30 days after its agreement expires or terminates under the conditions specified in § 441.11 of this subchapter.
A Medicaid agency may extend a provider agreement for a single period of up to 2 months beyond the original expiration date specified in the agreement if it receives written notice from the survey agency, before the expiration date of the agreement, that extension will not jeopardize the patients' health and safety, and—
(a) Is needed to prevent irreparable harm to the facility or hardship to the recipients in the facility; or
(b) Is needed because it is impracticable to determine, before the expiration date, whether the facility meets certification requirements.
(a) Under §§ 440.40(a) and 440.150 of this chapter, FFP is available in expenditures for NF and ICF/MR services only if the facility has been certified as meeting the requirements for Medicaid participation, as evidenced by a provider agreement executed under this part. An agreement is not valid evidence that a facility has met those requirements if CMS determines that—
(1) The survey agency failed to apply the applicable requirements under subpart B of part 483 of this chapter for NFs or subpart I of part 483 of this chapter, which set forth the conditions of participation for ICFs/MR.
(2) The survey agency failed to follow the rules and procedures for certification set forth in subpart C of this part, subpart E of part 488, and § 431.610 of this subchapter;
(3) The survey agency failed to perform any of the functions specified in § 431.610(g) of this subchapter relating to evaluating and acting on information about the facility and inspecting the facility;
(4) The agency failed to use the Federal standards, and the forms, methods and procedures prescribed by CMS as required under § 431.610(f)(1) or § 488.318(b) of this chapter, for determining the qualifications of providers; or
(5) The survey agency failed to adhere to the following principles in determining compliance:
(i) The survey process is the means to assess compliance with Federal health, safety and quality standards;
(ii) The survey process uses resident outcomes as the primary means to establish the compliance status of facilities. Specifically, surveyors will directly observe the actual provision of care and services to residents, and the effects of that care, to assess whether the care provided meets the needs of individual residents;
(iii) Surveyors are professionals who use their judgment, in concert with Federal forms and procedures, to determine compliance;
(iv) Federal procedures are used by all surveyors to ensure uniform and consistent application and interpretation of Federal requirements;
(v) Federal forms are used by all surveyors to ensure proper recording of findings and to document the basis for the findings.
(6) The survey agency failed to assess in a systematic manner a facility's actual provision of care and services to residents and effects of that care on residents.
(7) Required elements of the NF survey process fails to include all of the following:
(i) An entrance conference;
(ii) A resident-centered tour of facility;
(iii) An in-depth review of a sample of residents including observation, interview and record review;
(iv) Observation of the preparation and administration of drugs for a sample of residents;
(v) Evaluation of a facility's meals, dining areas and eating assistance procedures;
(vi) Formulation of a deficiency statement based on the incorporation of all appropriate findings onto the survey report form;
(vii) An exit conference; and
(viii) Follow-up surveys as appropriate.
(8) The agreement's terms and conditions do not meet the requirements of this subpart.
(b) The Administrator will make the determination under paragraph (a) of this section through onsite surveys, other Federal reviews, State certification records, or reports he may require from the Medicaid or survey agency.
(c) If the Administrator disallows a State's claim for FFP because of a determination under paragraph (a) of this section, the State is entitled upon request to reconsideration of the disallowance under 45 CFR part 16.
(a)
(b)
(2)
(ii) When the State acts under instructions from CMS, FFP ends on the date specified by CMS (CMS instructs the State to terminate the Medicaid provider agreement when CMS in validating a State survey agency certification, determines that an ICF/MR does not meet the requirements for participation.)
(3)
(c)
(2) If State law, or a Federal or State court order or injunction, requires the agency to extend the provider agreement or continue payments to a facility after the dates specified in paragraph (d) of this section, FFP is not available in those payments.
(d)
(i) The evidentiary hearing required under § 431.153 of this chapter is provided by the State agency after the effective date of termination or expiration (or, if begun before termination or expiration, is not completed until after that date); and
(ii) Termination or nonrenewal action is based on a survey agency certification that there is no jeopardy to recipients' health and safety.
(2)
(i) The date of issuance of an administrative hearing decision that upholds the agency's termination or nonrenewal action.
(ii) The 120th day after the effective date of termination of the facility's provider agreement or, if the agreement is not terminated, the 120th day after the effective date of expiration. (If a hearing decision that upholds the facility is issued after the end of the 120-day period, when FFP has already been discontinued, the rules of § 442.42 on retroactive agreements apply).
(e)
(a)
(b)
A State plan must provide that the requirements of this subpart and part 483 are met.
(a) This section states the requirements for obtaining notice of an ICF/MR's certification before a Medicaid agency executes a provider agreement under § 442.12.
(b) The agency must obtain notice of certification from the Secretary for an ICF/MR located on an Indian reservation.
(c) The agency must obtain notice of certification from the survey agency for all other ICFs/MR.
(d) The notice must indicate that one of the following provisions pertains to the ICF/MR:
(1) An ICF/MR meets the conditions of participation set forth in subpart I of part 483 of this chapter.
(2) The ICF/MR has been granted a waiver or variance by CMS or the survey agency under subpart I of part 483 of this chapter.
(3) An ICF/MR has been certified with standard-level deficiencies and
(i) All conditions of participation are found met; and
(ii) The facility submits an acceptable plan of correction covering the remaining deficiencies, subject to other limitations specified in § 442.105.
(e) The failure to meet one or more of the applicable conditions of participation is cause for termination or non-renewal of the ICF/MR provider agreement.
If a survey agency finds a facility deficient in meeting the standards for ICFs/MR, as specified under subpart I of part 483 of this chapter, the agency may certify the facility for Medicaid purposes under the following conditions:
(a) The agency finds that the facility's deficiencies, individually or in combination, do not jeopardize the patient's health and safety, nor seriously limit the facility's capacity to give adequate care.
(b) The agency finds acceptable the facility's written plan for correcting the deficiencies.
(c) If a facility was previously certified with a deficiency and has a different deficiency at the time of the next survey, the agency documents that the facility—
(1) Was unable to stay in compliance with the standard for ICFs/MR for reasons beyond its control, or despite intensive efforts to comply; and
(2) Is making the best use of its resources to furnish adequate care.
(d) If a facility has the same deficiency it had under the prior certification, the agency documents that the facility—
(1) Did achieve compliance with the standard for ICFs/MR at some time during the prior certification period;
(2) Made a good faith effort, as judged by the survey agency, to stay in compliance; and
(3) Again became out of compliance for reasons beyond its control.
(a) A survey agency may certify a facility that fully meets applicable requirements for up to 12 months.
(b) The survey agency may notify the Medicaid agency that the term of a provider agreement may be extended up to 2 months after the expiration date of the agreement under the conditions specified in § 442.16.
(a) Facilities with deficiencies may be certified under § 442.105 for the period specified in either paragraph (b) or (c) of this section.
(b) The survey agency may certify a facility for a period that ends no later than 60 days after the last day specified in the plan for correcting deficiencies. The certification period must not exceed 12 months, including the period allowed for corrections.
(c) The survey agency may certify a facility for up to 12 months with a condition that the certification will be automatically canceled on a specified date within the certification period unless—
(1) The survey agency finds that all deficiencies have been satisfactorily corrected; or
(2) The survey agency finds and notifies the Medicaid agency that the facility has made substantial progress in correcting the deficiencies and has a new plan for correction that is acceptable.
(a) A survey agency must terminate a facility's certification if it determines that—
(1) The facility no longer meets conditions of participation for ICFs/MR as specified in subpart I of part 483 of this chapter.
(2) The facility's deficiencies pose immediate jeopardy to residents' health and safety.
(b) Subsequent to a certification of a facility's noncompliance, the Medicaid agency must, in terminating the provider agreement, follow the appeals process specified in part 431, subpart D of this chapter.
(a)
(b)
(1) Provide the facility up to 60 days to correct the cited deficiencies and comply with conditions of participation for ICFs/MR.
(2) If at the end of the specified period the facility has not achieved compliance, give the facility notice of intent to deny payment for new admissions, and opportunity for an informal hearing.
(3) If the facility requests a hearing, provide an informal hearing that includes—
(i) The opportunity for the facility to present, before a State Medicaid official who was not involved in making the initial determination, evidence or documentation, in writing or in person, to refute the decision that the facility is out of compliance with the conditions of participation for ICFs/MR.
(ii) A written decision setting forth the factual and legal bases pertinent to a resolution of the dispute.
(4) If the decision of the informal hearing is to deny payments for new admissions, provide the facility and the public, at least 15 days before the effective date of the sanction, with a notice that includes the effective date and the reasons for the denial of payments.
(a)
(1) The facility has corrected the deficiencies or is making a good faith effort to achieve compliance with the conditions of participation for ICFs/MR; or
(2) The deficiencies are such that it is necessary to terminate the facility's provider agreement.
(b)
(1) Upon the agency's finding that the facility has been unable to achieve compliance with the conditions of participation for ICFs/MR during the period that payments for new admissions have been denied;
(2) Effective the day following the last day of the denial of payments period; and
(3) In accordance with the procedures for appeal of terminations set forth in subpart D of part 431 of this chapter.
Sec. 1102 of the Social Security Act (42 U.S.C. 1302).
This subpart prescribes State plan requirements, FFP limitations and procedures concerning payments made by State Medicaid agencies for Medicaid services.
(a)
(b)
(c)
(d)
(1) To the provider; or
(2) To the recipient if he is a noncash recipient eligible to receive the payment under § 447.25; or
(3) In accordance with paragraphs (e), (f), and (g) of this section.
(e)
(f)
(1) Related to the cost of processing the billing;
(2) Not related on a percentage or other basis to the amount that is billed or collected; and
(3) Not dependent upon the collection of the payment.
(g)
(1) The employer of the practitioner, if the practitioner is required as a condition of employment to turn over his fees to the employer;
(2) The facility in which the service is provided, if the practitioner has a contract under which the facility submits the claim; or
(3) A foundation, plan, or similar organization operating an organized health care delivery system, if the practitioner has a contract under which the organization submits the claim.
(h)
A State plan must provide that the Medicaid agency must limit participation in the Medicaid program to providers who accept, as payment in full, the amounts paid by the agency plus any deductible, coinsurance or copayment required by the plan to be paid by the individual. However, the provider may not deny services to any eligible individual on account of the individual's inability to pay the cost sharing amount imposed by the plan in accordance with § 431.55(g) or § 447.53. The previous sentence does not apply to an individual who is able to pay. An individual's inability to pay does not eliminate his or her liability for the cost sharing charge.
A State plan must provide for the following:
(a) In the case of an individual who is eligible for medical assistance under the plan for service(s) for which a third party or parties is liable for payment, if the total amount of the established liability of the third party or parties for the service is—
(1) Equal to or greater than the amount payable under the State plan (which includes, when applicable, cost-sharing payments provided for in §§ 447.53 through 447.56), the provider furnishing the service to the individual may not seek to collect from the individual (or any financially responsible relative or representative of that individual) any payment amount for that service; or
(2) Less than the amount payable under the State plan (including cost sharing payments set forth in §§ 447.53 through 447.56), the provider furnishing the service to that individual may collect from the individual (or any financially responsible relative or representative of the individual) an amount which is the lesser of—
(i) Any cost-sharing payment amount imposed upon the individual under §§ 447.53 through 447.56; or
(ii) An amount which represents the difference between the amount payable under the State plan (which includes, where applicable, cost-sharing payments provided for in §§ 447.53 through 447.56) and the total of the established third party liability for the services.
(b) A provider may not refuse to furnish services covered under the plan to an individual who is eligible for medical assistance under the plan on account of a third party's potential liability for the service(s).
If a provider seeks to collect from an individual (or any financially responsible relative or representative of that individual) an amount that exceeds an amount specified under § 447.20(a)—
(a) The Medicaid agency may provide for a reduction of any payment amount otherwise due to the provider in addition to any other sanction available to the agency; and
(b) The reduction may be equal to up to three times the amount that the provider sought to collect in violation of § 447.20(a).
(a)
(b)
(1) Provide for direct payments; and
(2) Specify the conditions under which payments are made.
(c)
(1) Who is receiving assistance under the State's approved plan under title I, IV-A, X, XIV or XVI (AABD) of the Act; or
(2) To whom supplemental security benefits are being paid under title XVI of the Act; or
(3) Who is receiving or eligible for a State supplementary payment or would be eligible if he were not in a medical institution, and who is eligible for Medicaid as a categorically needy recipient.
(d)
(2) Direct payments must be supported by providers' bills for services.
(a)
(b)
(1) The provider has not made arrangements satisfactory to CMS to repay the Medicare overpayment; or
(2) CMS has been unable to collect information from the provider to determine the existence or amount of Medicare overpayment.
(c) The Federal share of Medicaid payments may be withheld with respect to the following providers:
(1) An institutional provider that has or previously had in effect a Medicare provider agreement under section 1866 of the Act; and
(2) A Medicaid provider who has previously accepted Medicare payment on the basis of an assignment under section 1842(b)(3)(B)(ii) of the Act; and during the 12 month period preceding the quarter in which the Federal share is to be withheld for a Medicare overpayment, submitted no claims under Medicare or submitted claims which total less than the amount of overpayment.
(d)
(2) The order to reduce payment to the provider will remain in effect until—
(i) The Medicaid agency determines that the overpayment has been completely recovered; or
(ii) CMS terminates the order.
(3) CMS may withhold FFP from any State that does not comply with the order specified in paragraph (d)(1) of this section to reduce payment to the provider and claims FFP for the expenditure on its quarterly expenditure report.
(e)
(2) The notice will include the instruction to reduce State payments, as provided under paragraph (d) of this section.
(3) CMS will send the notice referred to in paragraph (e)(1) by certified mail, return receipt requested.
(4) Each Medicaid agency must identify the amount of payment due the
(5) The Medicaid agency may appeal any disallowance of FFP resulting from the withholding decision to the Grant Appeals Board, in accordance with 45 CFR part 16.
(f) Amount to be withheld. CMS may require the Medicaid agency to reduce the Federal share of its payment to the provider by the lesser of the following amounts.
(1) The Federal matching share of payments to the provider, or
(2) The total Medicare overpayment to the provider.
(g)
(h)
(i)
(i) The Medicare overpayment is completely recovered:
(ii) The institution or person makes an agreement satisfactory to CMS to repay the overpayment; or
(iii) CMS determines that there is no overpayment based on newly acquired evidence or a subsequent audit.
(2) CMS will notify each State that previously received a notice ordering the withholding that the withholding has been terminated.
(j)
(k)
(a)
(b)
(i) Notice that—
(A) There has been an overpayment;
(B) Repayment is required; and
(C) The overpayment determination is subject to agency appeal procedures, but we may withhold Medicare payments while an appeal is in progress.
(ii) Notice that—
(A) Information is needed to determine the amount of overpayment if any; and
(B) The provider has at least 30 days in which to supply the information to the agency.
(2) Notice that, 30 days or later from the date of the notice, the agency intends to refer the case to CMS for withholding of Medicare payments.
(3) The agency must send all notices to providers by certified mail, return receipt requested.
(c)
(1) A statement of the reason that withholding is requested.
(2) The amount of overpayment, type of overpayment, date the overpayment was determined, and the closing date of the pertinent cost reporting period (if applicable).
(3) The quarter in which the overpayment was reported on the quarterly expenditure report (Form CMS 64).
(4) As needed, and upon request from CMS, the names and addresses of the provider's officers and owners for each period that there is an outstanding overpayment.
(5) A statement of assurance that the State agency has met the notice requirements under paragraph (b) of this section.
(6) As needed, and upon request for CMS, copies of notices (under paragraph (b) of this section), and reports of contact or attempted contact with the provider concerning the overpayment, including any reduction or suspension of Medicaid payments made with respect to that overpayment.
(7) A copy of the provider's agreement with the agency under § 431.107 of this chapter.
(d)
(i) The Medicaid provider makes an agreement satisfactory to the agency to repay the overpayment;
(ii) The Medicaid overpayment is completely recovered; or
(iii) The agency determines that there is no overpayment, based on newly acquired evidence or subsequent audit.
(2) Upon receipt of notification from the State agency, CMS will terminate withholding.
(e)
(f)
(a) The Medicaid agency may make payments to reserve a bed during a recipient's temporary absence from an inpatient facility, if—
(1) The State plan provides for such payments and specifies any limitations on the policy; and
(2) Absences for purposes other than required hospitalization (which cannot be anticipated and planned) are included in the patient's plan of care.
(b) An agency that pays for reserved beds in an inpatient facility may pay less for a reserved bed than an occupied bed if there is a cost differential between the two beds. (Section 1102 of the Act.)
(a)
(1) State plan requirements for—
(i) Timely processing of claims for payment;
(ii) Prepayment and postpayment claims reviews; and
(2) Conditions under which the Administrator may grant waivers of the time requirements.
(b)
A
(1) Two or more health care practitioners practice their professions at a common physical location;
(2) The practitioners share common waiting areas, examining rooms, treatment rooms, or other space, the services of supporting staff, or equipment;
(3) The practitioners have a person (who may himself be a practitioner)—
(i) Who is in charge of, controls, manages, or supervises substantial aspects of the arrangement or operation for the delivery of health or medical services at the common physical location other than the direct furnishing of professional health care services by the practitioners to their patients; or
(ii) Who makes available to the practitioners the services of supporting staff who are not employees of the practitioners; and
(iii) Who is compensated in whole or in part, for the use of the common physical location or related support services, on a basis related to amounts charged or collected for the services rendered or ordered at the location or on any basis clearly unrelated to the value of the services provided by the person; and
(4) At least one of the practitioners received payments on a fee-for-service basis under titles V, XVIII, and XIX in an amount exceeding $5,000 for any one month during the preceding 12 months or in an aggregate amount exceeding $40,000 during the preceding 12 months.
(c)
(2) Specify the definition of a claim, as provided in paragraph (b) of this section, to be used in meeting the requirements for timely claims payment. The definition may vary by type of service (e.g., physician service, hospital service).
(d)
(2) The agency must pay 90 percent of all clean claims from practitioners, who are in individual or group practice or who practice in shared health facilities, within 30 days of the date of receipt.
(3) The agency must pay 99 percent of all clean claims from practitioners, who are in individual or group practice or who practice in shared health facilities, within 90 days of the date of receipt.
(4) The agency must pay all other claims within 12 months of the date of receipt, except in the following circumstances:
(i) This time limitation does not apply to retroactive adjustments paid to providers who are reimbursed under a retrospective payment system, as defined in § 447.272 of this part.
(ii) If a claim for payment under Medicare has been filed in a timely manner, the agency may pay a Medicaid claim relating to the same services within 6 months after the agency or the provider receives notice of the disposition of the Medicare claim.
(iii) The time limitation does not apply to claims from providers under investigation for fraud or abuse.
(iv) The agency may make payments at any time in accordance with a court order, to carry out hearing decisions or agency corrective actions taken to resolve a dispute, or to extend the benefits of a hearing decision, corrective action, or court order to others in the same situation as those directly affected by it.
(5) The date of receipt is the date the agency receives the claim, as indicated by its date stamp on the claim.
(6) The date of payment is the date of the check or other form of payment.
(e)
(2) The agency's request for a waiver must contain a written plan of correction specifying all steps it will take to meet the requirements of this section.
(3) The Administrator will review each case and if he approves a waiver, will specify its expiration date, based on the State's capability and efforts to meet the requirements of this section.
(f)
(i) Verification that the recipient was included in the eligibility file and that the provider was authorized to furnish the service at the time the service was furnished;
(ii) Checks that the number of visits and services delivered are logically consistent with the recipient's characteristics and circumstances, such as type of illness, age, sex, service location;
(iii) Verification that the claim does not duplicate or conflict with one reviewed previously or currently being reviewed;
(iv) Verification that a payment does not exceed any reimbursement rates or limits in the State plan; and
(v) Checks for third party liability within the requirements of § 433.137 of this chapter.
(2) The agency must conduct post-payment claims review that meets the requirements of parts 455 and 456 of this chapter, dealing with fraud and utilization control.
(g)
(a)
(b)
(c)
(2)
(3)
(a) Section 1902(a)(14) of the Act permits States to require certain recipients to share some of the costs of Medicaid by imposing upon them such payments as enrollment fees, premiums, deductibles, coinsurance, co-payments, or similar cost sharing charges. For States that impose cost sharing payments, §§ 447.51 through 447.59 prescribe State plan requirements and options for cost sharing, specify the standards and conditions under which States may impose cost sharing, set forth minimum amounts and the methods for determining maximum amounts, and prescribe conditions for FFP that relate to cost sharing requirements.
(a) The plan must provide that the Medicaid agency does not impose any enrollment fee, premium, or similar charge upon categorically needy individuals, as defined in §§ 435.4 and 436.3 of this subchapter, for any services available under the plan.
(b) The plan may impose an enrollment fee, premium, or similar charge on medically needy individuals, as defined in §§ 435.4 and 436.3 of this subchapter, for any services available under the plan.
(c) For each charge imposed under paragraph (b) of this section, the plan must specify—
(1) The amount of the charge;
(2) The period of liability for the charge; and
(3) The consequences for an individual who does not pay.
(d) The plan must provide that any charge imposed under paragraph (b) of this section is related to total gross family income as set forth under § 447.52.
For the purpose of relating the amount of an enrollment fee, premium, or similar charge to total gross family income, as required under § 447.51(d), the following rules apply:
(a)
(1) One- or two-person family with monthly gross income of $150 or less;
(2) Three- or four-person family with monthly gross income of $300 or less; and
(3) Five- or more-person family with monthly gross income of $350 or less.
(b)
(c)
(a)
(b)
(1)
(2)
(3)
(4)
(i) Placing the patient's health in serious jeopardy;
(ii) Serious impairment to bodily functions; or
(iii) Serious dysfunction of any bodily organ or part.
(5)
(c)
(d)
(1) The service for which the charge is made;
(2) The amount of the charge;
(3) The basis for determining the charge;
(4) The basis for determining whether an individual is unable to pay the charge and the means by which such an individual will be identified to providers; and
(5) The procedures for implementing and enforcing the exclusions from cost sharing found in paragraph (b) of this section.
(e) No provider may deny services, to an individual who is eligible for the services, on account of the individual's inability to pay the cost sharing.
(a)
(1) Any deductible it imposes does not exceed $2.00 per month per family for each period of Medicaid eligibility. For example, if Medicaid eligibility is certified for a 3-month period, the maximum deductible which may be imposed on a family for that period of eligibility is $6.00;
(2) Any coinsurance rate it imposes does not exceed 5 percent of the payment the agency makes for the services; and
(3) Any co-payments it imposes do not exceed the amounts shown in the following table:
(b)
(c)
(d)
At 73 FR 71851, Nov. 25, 2008, § 447.54 was amended by revising the section heading, (a) introductory text, (1) and (3), adding a new introductory text and (a)(4), effective March 27, 2009. At 74 FR 4888, March 27, 2009, the effective date was delayed until Dec. 31, 2009. For the convenience of the user, the added and revised text is set forth as follows:
Except as provided at §§ 447.62 through 447.82 of this part, the following requirements must be met:
(a)
(1) For Federal FY 2009, any deductible it imposes does not exceed $2.30 per month per family for each period of Medicaid eligibility. For example, if Medicaid eligibility is certified for a 3-month period, the maximum deductible which may be imposed on a family is $6.90. Thereafter, any deductible should not exceed these amounts as updated each October 1 by the percentage increase in the medical care component of the CPI-U for the period of September to September ending in the preceding calendar year, and then rounded to the next higher 5-cent increment.
(3)(i) For Federal FY 2009, any co-payments it imposes under a fee-for-service delivery system do not exceed the amounts shown in the following table:
(ii) Thereafter, any copayments should not exceed these amounts as updated each October 1 by the percentage increase in the medical care component of the CPI-U for the period of September to September ending in the preceding calendar year and then rounded to the next higher 5-cent increment.
(4) For Federal FY 2009, any copayment for services provided by an MCO may not exceed the copayment permitted under paragraph (a)(3)(i) of this section for comparable services under a fee-for-service delivery system, except as provided in this paragraph. When there is no fee-for-service delivery system, the copayment may not exceed $3.40 per visit or for individuals referenced in an approved State child health plan under title XXI pursuant to § 457.70(c), $5.70 per visit. In succeeding years, any copayment should not exceed these amounts as updated each October 1 by the percentage increase in the medical care component of the CPI-U for the period of September to September ending in the preceding calendar year and then rounded to the next higher 5-cent increment.
(a) The plan may provide for a standard, or fixed, co-payment amount for any service.
(b) This standard copayment amount for any service may be determined by applying the maximum co-payment amounts specified in § 447.55 (a) and (b) to the agency's average or typical payment for that service. For example, if the agency's typical payment for prescribed drugs is $4 to $5 per prescription, the agency might set a standard copayment of $0.50 per prescription.
At 73 FR 71851, Nov. 25, 2008, § 447.55 was amended by revising paragraph (b), effective March 27, 2009. At 74 FR 4888, March 27, 2009, the effective date was delayed until Dec. 31, 2009. For the convenience of the user, the revised text is set forth as follows:
(b) This standard copayment amount for any service may be determined by applying the maximum copayment amounts specified in § 447.54(a) and (b) to the agency's average or typical payment for that service. For example, if the agency's typical payment for prescribed drugs is $4 to $5 per prescription, the agency might set a standard copayment of $.60 per prescription. This standard copayment may be adjusted based on updated copayments as permitted under § 447.54(a)(3).
Subject to the maximum allowable charges specified in § 447.54 (a) and (b), the plan may provide for income-related deductible, coinsurance or co-payment charges. For example, an agency may impose a higher charge on
(a) The plan must provide that the agency does not increase the payment it makes to any provider to offset uncollected amounts for deductibles, coinsurance, copayments or similar charges that the provider has waived or are uncollectable, except as permitted under paragraph (b) of this section.
(b) For those providers that the agency reimburses under Medicare reasonable cost reimbursement principles, in accordance with subpart B of this part, an agency may increase its payment to offset uncollected deductible, coinsurance, copayment, or similar charges that are bad debts of providers.
If the agency contracts with a prepaid capitation organization that does not impose the agency's deductibles, coinsurance, co-payments or similar charges on its recipient members, the plan must provide that the agency calculates its payments to the organization as if those cost sharing charges were collected.
No FFP in the State's expenditures for services is available for—
(a) Any cost sharing amounts that recipients should have paid as enrollment fees, premiums, deductibles, coinsurance, copayments, or similar charges under §§ 447.50 through 447.58 (except for amounts that the agency pays as bad debts of providers under § 447.57); and
(b) Any amounts paid by the agency on behalf of ineligible individuals, whether or not the individual had paid any required premium or enrollment fee.
Contracts with MCOs must provide that any cost-sharing charges the MCO imposes on Medicaid enrollees are in accordance with the requirements set forth in §§ 447.50 and 447.53 through 447.58 for cost-sharing charges imposed by the State agency.
At 73 FR 71851, Nov. 25, 2008, subject group “Alternative Premiums and Cost Sharing Under Section 1916A” was added, effective March 27, 2009. At 74 FR 4888, March 27, 2009, the effective date was delayed until Dec. 31, 2009.
(a) Section 1916A of the Act sets forth options for alternative premiums and cost sharing, which are premiums and cost sharing that are not subject to the limitations under section 1916 of the Act as described in §§ 447.51 through 447.56. For States that impose alternative premiums, §§ 447.64 through 447.66, 447.72, 447.74, 447.78, and 447.80 prescribe State plan requirements and options for alternative premiums and the standards and conditions under which States may impose them. For States that impose alternative cost sharing, §§ 447.68 through 447.72, 447.74, 447.78, and 447.80 prescribe State plan requirements and options for alternative cost sharing and the standards and conditions under which States may impose alternative cost sharing. For other individuals, premiums and cost sharing must comply with the requirements described in §§ 447.50 through 447.60.
(b) Neither section 1916A of the Act nor the regulations referenced in paragraph (a) of this section affect the following:
(1) The Secretary's authority to waive limitations on premiums and cost sharing under this subpart.
(2) Existing waivers with regard to the imposition of premiums and cost sharing.
When a State imposes alternative premiums, enrollment fees, or similar fees on individuals, the State plan must describe the following:
(a) The group or groups of individuals that may be subject to the premiums, enrollment fees, or similar charges.
(b) The schedule of the premiums, enrollment fees, or similar fees imposed.
(c) The methodology used to determine family income for purposes of the limitations related to family income level that are described below, including the period and periodicity of those determinations.
(d) The methodology used to ensure compliance with the requirements of § 447.78 that the aggregate amount of premiums and cost sharing imposed for all individuals in the family do not exceed 5 percent of the family income of the family involved.
(e) The process for informing the recipients, applicants, providers, and the public of the schedule of premiums, enrollment fees, or similar fees for a group or groups of individuals in accordance with § 447.76.
(f) The notice of, time frame for, and manner of required premium payments for a group or groups of individuals and the consequences for an individual who does not pay.
(a) States may not impose alternative premiums upon the following individuals:
(1) Individuals under 18 years of age that are required to be provided medical assistance under section 1902(a)(10)(A)(i) of the Act, and including individuals with respect to whom child welfare services are made available under Part B of title IV of the Act on the basis of being a child in foster care and individuals with respect to whom adoption or foster care assistance is made available under Part E of that title, without regard to age.
(2) Pregnant women.
(3) Any terminally ill individual receiving hospice care, as defined in section 1905(o) of the Act.
(4) Any individual who is an inpatient in a hospital, nursing facility, intermediate care facility, or other medical institution, if the individual is required, as a condition of receiving services in that institution under the State plan, to spend for costs of medical care all but a minimal amount of the individual's income required for personal needs.
(5) Women who are receiving Medicaid on the basis of the breast or cervical cancer eligibility group under sections 1902(a)(10)(A)(ii)(XVIII) and 1902(aa) of the Act.
(6) Disabled children who are receiving medical assistance by virtue of the application of sections 1902(a)(10)(A)(ii)(XIX) and 1902(cc) of the Act.
(b) States may exempt additional classes of individuals from premiums.
When a State imposes alternative copayments, coinsurance, deductibles, or similar cost sharing charges on individuals, the State plan must describe the following:
(a) The group or groups of individuals that may be subject to the cost sharing charge.
(b) The methodology used to determine family income, for purposes of the limitations on cost sharing related to family income that are described below, including the period and periodicity of those determinations.
(c) The item or service for which the charge is imposed.
(d) The methods, such as the use of integrated automated systems, for tracking cost sharing charges, informing recipients and providers of their liability, and notifying recipients and providers when individual recipients have paid the maximum cost sharing charges permitted for the period of time.
(e) The process for informing recipients, applicants, providers, and the public of the schedule of cost sharing charges for specific items and services
(f) The methodology used to ensure that:
(1) The aggregate amount of premiums and cost sharing imposed under section 1916 or section 1916A of the Act for individuals with family income above 100 percent of the FPL does not exceed 5 percent of the family income of the family involved.
(2) The aggregate amount of cost sharing under sections 1916, 1916A(c), and/or 1916A(e) of the Act for individuals with family income at or below 100 percent of the FPL does not exceed 5 percent of the family income of the family involved.
(g) The notice of, time frame for, and manner of required cost sharing and the consequences for failure to
(a)(1) States may not impose alternative cost sharing for the following items or services. Except as indicated, these limits do not apply to alternative cost sharing for non-preferred prescription drugs within a class of such drugs or non-emergency use of the emergency room.
(i) Services furnished to individuals under 18 years of age who are required to be provided Medicaid under section 1902(a)(10)(A)(i) of the Act, and including services furnished to individuals with respect to whom child welfare services are made available under Part B of title IV of the Act on the basis of being a child in foster care and individuals with respect to whom adoption or foster care assistance is made available under Part E of that title, without regard to age.
(ii) Preventive services (for example, well baby and well child care and immunizations) provided to children under 18 years of age regardless of family income.
(iii) Services furnished to pregnant women, if those services relate to pregnancy or to any other medical condition which may complicate the pregnancy.
(iv) Services furnished to a terminally ill individual who is receiving hospice care (as defined in section 1905(o) of the Act).
(v) Services furnished to any individual who is an inpatient in a hospital, nursing facility, intermediate care facility for the mentally retarded, or other medical institution, if the individual is required, as a condition of receiving services in that institution under the State plan, to spend for costs of medical care all but a minimal amount of the individual's income required for personal needs.
(vi) Emergency services as defined at § 447.53(b)(4), except charges for services furnished after the hospital has determined, based on the screening and any other services required under § 489.24 of this chapter, that the individual does not have an emergency medical condition consistent with the requirements of paragraph (a)(2) of this section and § 447.80(b)(1).
(vii) Family planning services and supplies described in section 1905(a)(4)(C) of the Act.
(viii) Services furnished to women who are receiving medical assistance by virtue of the application of sections 1902(a)(10)(A)(ii)(XVIII) and 1902(aa) of the Act (breast or cervical cancer provisions).
(ix) Services furnished to disabled children who are receiving medical assistance by virtue of the application of sections 1902(a)(10)(A)(ii)(XIX) and 1902(cc) of the Act.
(x) Preferred drugs within a class for individuals for whom cost sharing may not otherwise be imposed as described in paragraphs (a)(1)(i) through (ix) of this section.
(2) A State may impose nominal cost sharing as defined in § 447.54 for services furnished in a hospital emergency department, other than those required under § 489.24 of this chapter, if the hospital has determined based on the screening required under § 489.24 that the individual does not have an emergency medical condition, the requirements of § 447.80(b)(1) are met, and no cost sharing is imposed to receive the care through an outpatient department or another alternative health care provider in the geographic area of the hospital emergency department involved.
(b) In the case of a drug that is a preferred drug within a class, cost sharing may not exceed the levels permitted under section 1916 of the Act. Cost
(c) In the case of a drug that is not a preferred drug, the cost sharing is limited to the amount imposed for a preferred drug if the following conditions are met:
(1) The prescribing physician determines that the preferred drug would be less effective or would have adverse effects for the individual or both.
(2) State criteria for prior authorization, if any, are met.
(d) States may exempt additional individuals, items, or services from cost sharing.
(a) The State may not impose premiums under the State plan on individuals whose family income is at or below 100 percent of the FPL.
(b) The State may not impose cost sharing under the State plan on individuals whose family income is at or below 100 percent of the FPL, with the following exceptions:
(1) The State may impose cost sharing under the State plan on individuals whose family income is at or below 100 percent of the FPL under authority provided under section 1916 of the Act and consistent with the levels described in such section and § 447.54.
(2) The State may impose cost sharing for non-preferred drugs that does not exceed the nominal amount as defined in § 447.54.
(3) The State may impose cost sharing for non-emergency services furnished in a hospital emergency department that does not exceed the nominal amount as defined in § 447.54 as long as no cost sharing is imposed to receive such care through an outpatient department or other alternative non-emergency services provider in the geographic area of the hospital emergency department involved.
(c) Aggregate cost sharing of the family under sections 1916, 1916A(c), and/or 1916A(e) of the Act may not exceed the maximum permitted under § 447.78(b).
(a) The State may not impose premiums under the State plan on individuals whose family income exceeds 100 percent, but does not exceed 150 percent, of the FPL.
(b) Cost sharing may not exceed 10 percent of the payment the agency makes for the item or service, with the following exceptions:
(1) Cost sharing for non-preferred drugs cannot exceed the nominal amount as defined in § 447.54.
(2) Cost sharing for non-emergency services furnished in the hospital emergency department cannot exceed twice the nominal amount as defined in § 447.54. A hospital must meet the requirements described at § 447.80 before the cost sharing can be imposed.
(3) In the case of States that do not have fee-for-service payment rates, any copayment that the State imposes for services provided by an MCO may not exceed $3.40 per visit for Federal FY 2009 or for individuals referenced in an approved State child health plan under title XXI of the Act pursuant to § 457.70(c), $5.70 per visit for Federal FY 2009. Thereafter, any copayment may not exceed this amount as updated each October 1 by the percentage increase in the medical care component of the CPI-U for the period of September to September ending in the preceding calendar year and then rounded to the next highest 5-cent increment.
(c) Aggregate cost sharing of the family may not exceed the maximum permitted under § 447.78(a).
(a) States may impose premiums consistent with the aggregate limits set forth in § 447.78(a).
(b) Cost sharing may not exceed 20 percent of the payment the agency makes for the item (including a non-preferred drug) or service, with the following exception: In the case of States
(c) Aggregate premiums and cost sharing of the family may not exceed the maximum permitted under § 447.78(a).
(a) The State must make available to the groups in paragraph (b) of this section a public schedule that contains the following information:
(1) Current premiums, enrollment fees, or similar fees.
(2) Current cost sharing charges.
(3) The aggregate limit on premiums and cost sharing or just cost sharing.
(4) Mechanisms for making payments for required premiums and charges.
(5) The consequences for an applicant or recipient who does not pay a premium or charge.
(6) A list of hospitals charging alternative cost sharing for non-emergency use of the emergency department.
(7) Either a list of preferred drugs or a method to obtain such a list upon request.
(b) The State must make the public schedule available to the following:
(1) Recipients, at the time of their enrollment and reenrollment after a redetermination of eligibility, and when premiums, cost sharing charges, and the aggregate limits are revised.
(2) Applicants, at the time of application.
(3) All participating providers.
(4) The general public.
(a) If a State imposes alternative premiums or cost sharing, the total aggregate amount of premiums and cost sharing under section 1916, 1916A(a), 1916A(c) or 1916A(e) of the Act for individuals with family income above 100 percent of the FPL may not exceed 5 percent of the family's income for the monthly or quarterly period, as specified by the State in the State plan.
(b) The total aggregate amount of cost sharing under sections 1916, 1916A(c), and/or 1916A(e) of the Act for individuals with family income at or below 100 percent of the FPL may not exceed 5 percent of the family's income for the monthly or quarterly period, as specified in the State plan.
(c) Family income shall be determined in a manner and for that period as specified by the State in the State plan including the use of such disregards as the State may provide.
(1) States may use gross income or any other methodology.
(2) States may use a different methodology for determining the aggregate limits than they do for determining income eligibility.
(a) With respect to alternative premiums, a State may do the following:
(1) Require a group or groups of individuals to prepay.
(2) Terminate an individual from medical assistance on the basis of failure to pay for 60 days or more.
(3) Waive payment of a premium in any case where it determines that requiring the payment would create an undue hardship.
(b) With respect to alternative cost sharing, a State may permit a provider, including a pharmacy to require an individual, as a condition for receiving the item or service, to pay the cost sharing charge, except as specified in paragraphs (b)(1) through (3) of this section.
(1) A provider, including a pharmacy and a hospital, may not require an individual whose family income is at or below 100 percent of the FPL to pay the cost sharing charge as a condition of receiving the service.
(2) A hospital that has determined after an appropriate medical screening pursuant to § 489.24, that an individual does not have an emergency medical condition, before imposing cost sharing
(3) The provider is not prohibited by this authority from choosing to reduce or waive cost sharing on a case-by-case basis.
The plan must provide that the agency reduces the payment it makes to any provider by the amount of a recipient's cost sharing obligation, regardless of whether the provider successfully collects the cost sharing.
(a) The FMAP rate for medical assistance payments made available to a child during a presumptive eligibility period under section 1920A of the Act is the regular FMAP under title XIX, based on the category of medical assistance; that is, the enhanced FMAP is not available for section 1920A presumptive eligibility expenditures.
(b) States have the following 3 options for identifying Medicaid section 1920A presumptive eligibility expenditures and the application of payments for those expenditures:
(1) A State may identify Medicaid section 1920A presumptive eligibility expenditures in the quarter expended with no further adjustment based on the results of a subsequent actual eligibility determination (if any).
(2) A State may identify Medicaid section 1920A presumptive eligibility expenditures in the quarter expended but may adjust reported expenditures based on results of the actual eligibility determination (if any) to reflect the actual eligibility status of the individual, if other than presumptively eligible.
(3) A State may elect to delay submission of claims for payments of section 1920A presumptive eligibility expenditures until after the actual eligibility determination (if any) is made and, at that time identify such expenditures based on the actual eligibility status of individuals if other than presumptively eligible. At that time, the State would, as appropriate, recategorize the medical assistance expenditures made during the section 1920A presumptive eligibility period based on the results of the actual eligibility determination, and claim them appropriately.
This subpart prescribes State plan requirements for setting payment rates to implement, in part, section 1902(a)(30) of the Act, which requires that payments for services be consistent with efficiency, economy, and quality of care.
(a) A State plan must provide that the requirements in this subpart are met.
(b) The plan must describe the policy and the methods to be used in setting payment rates for each type of service included in the State's Medicaid program.
The Medicaid agency must assure appropriate audit of records if payment is based on costs of services or on a fee plus cost of materials.
(a) The agency must maintain documentation of payment rates and make it available to HHS upon request.
(b) The agency must record, in State manuals or other official files, the following information for increases in
(1) An estimate of the percentile of the range of customary charges to which the revised payment structure equates and a description of the methods used to make the estimate.
(2) An estimate of the composite average percentage increase of the revised payment rates over the preceding rates.
The agency's payments must be sufficient to enlist enough providers so that services under the plan are available to recipients at least to the extent that those services are available to the general population.
(a)
(b)
(1) The change is being made to conform to Medicare methods or levels of reimbursement;
(2) The change is required by court order; or
(3) The change is based on changes in wholesalers' or manufacturers' prices of drugs or materials, if the agency's reimbursement system is based on material cost plus a professional fee.
(c)
(1) Describe the proposed change in methods and standards;
(2) Give an estimate of any expected increase or decrease in annual aggregate expenditures;
(3) Explain why the agency is changing its methods and standards;
(4) Identify a local agency in each county (such as the social services agency or health department) where copies of the proposed changes are available for public review;
(5) Give an address where written comments may be sent and reviewed by the public; and
(6) If there are public hearings, give the location, date and time for hearings or tell how this information may be obtained.
(d)
(1) Be published before the proposed effective date of the change; and
(2) Appear as a public announcement in one of the following publications:
(i) A State register similar to the
(ii) The newspaper of widest circulation in each city with a population of 50,000 or more.
(iii) The newspaper of widest circulation in the State, if there is no city with a population of 50,000 or more.
(a)
(b)
(1) Indian Health Services facilities and tribal facilities that are funded through the Indian Self-Determination and Education Assistance Act (Pub. L. 93-638);
(2) Managed Care Organizations (MCOs), Prepaid Inpatient
Health Plans (PIHPs), and Prepaid Ambulatory Health Plans (PAHPs) which are organized and operating in accordance with the provisions of 42 CFR 438;
(3) Federally Qualified Health Centers (FQHCs) and Rural
Health Clinics (RHCs) reimbursed in accordance with Section 1902(bb) of the Act; and
(4)
(i) The aggregate DSH limit using the Federal share of the DSH limit under section 1923(f) of the Act.
(ii) The hospital-specific DSH limit in section 1923(g) of the Act.
(iii) The aggregate DSH limit for institutions for mental disease (IMDs) under section 1923(h) of the Act.
(a)
(2) Reasonable methods of identifying and allocating costs to Medicaid will be determined by the Secretary in accordance with sections 1902, 1903, and 1905 of the Act, as well as 45 CFR 92.22 and Medicare cost principles when applicable.
(3) Institutional governmentally-operated health care providers (i.e., hospitals, nursing facilities, and ICFs/MR) are required to provide the State with data extracted from primary source documents as well as copies of the source documents. These source documents would include the health care provider's Medicare cost report (or Medicaid cost report for intermediate nursing facility care and ICFs/MR consistent with Medicare cost reporting principles, and audited financial statements that will be used in conjunction with information provided by the States' Medicaid Management Information System (MMIS).
(4) Medicaid costs for non-institutional governmentally-operated health care providers must be supported by auditable documentation in a form approved by the Secretary that is consistent with § 433.51(b)(1) through (b)(4) of this chapter.
(d)
(1) In accordance with paragraph (c) of this section, each provider must submit annually a cost report to the Medicaid agency that reflects the individual provider's cost of serving Medicaid recipients during the year.
(2) States may utilize most recently filed cost reports to develop interim rates and may trend those interim rates by an applicable health care-related index. Interim reconciliations must be performed by reconciling the interim Medicaid payment rates to the filed cost report for the spending year in which interim payment rates were made.
(3) Final reconciliation must be performed annually by reconciling any interim payments to the finalized cost report for the spending year in which any interim payment rates were made.
(4) Non-institutional governmentally-operated health care providers must utilize a cost report, approved by the Secretary, beginning in their Medicaid State plan rate year 2009. Interim rates set by States for purposes of Medicaid payments funded by certified public expenditures in Medicaid State plan rate year 2009 must be calculated based on cost data from at least one quarter of their Medicaid State plan rate year 2008 documented in accordance with the cost report approved by the Secretary. Existing certified public expenditure methodologies can be used to make Medicaid payments during Medicaid State plan rate year 2008.
(e)
(f)
(g)
(1)
(2)
(3)
(i) For any cost reports that are not finalized at the time the State performs the review of Medicaid payments to institutional governmentally-operated health care providers, the State should use the “as filed” cost report and indicate such in the summary report to CMS. The State should then submit a corrected summary report to CMS within 30 days of the finalization of the cost report.
(a) Payment methodologies must permit the provider to receive and retain the full amount of the total computable payment for services furnished under the approved State plan (or the approved provisions of a waiver or demonstration if applicable). The Secretary will determine compliance with this provision by examining any associated transactions that are related to the provider's total computable payment to ensure that the State's claimed expenditure, which serves as the basis for Federal Financial Participation, is equal to the State's net expenditure, and that the full amount of the non-Federal share of the payment has been satisfied.
(b)
(1) Use of Medicaid revenues to fund payments that are normal operating expenses of conducting business, such as payments related to taxes (including permissible health-care related taxes), fees, or business relationships with governments unrelated to Medicaid in which there is no connection to Medicaid payment.
(2) Payments authorized by Sections 701(d) and 705 of the Benefits Improvement Act of 2000 (BIPA).
(a) This subpart implements section 1902(a)(13)(A) of the Act, which requires that the State plan provide for payment for hospital and long-term care facility services through the use of rates that the State finds, and makes assurances satisfactory to the Secretary, are reasonable and adequate to meet the costs that must be incurred by efficiently and economically operated facilities to provide services in conformity with State and Federal laws, regulations, and quality and safety standards.
(b) Section 447.253(a)(2) implements section 1902(a)(30) of the Act, which requires that payments be consistent with efficiency, economy, and quality of care;
(c) Sections 447.253 (c) and (d) implement sections 1902(a)(13)(B) and 1902(a)(13)(C) of the Act, which require a State Medicaid agency to make certain assurances to the Secretary regarding increases in payments resulting solely from changes in ownerships of hospitals, NFs, and ICFs/MR.
(d) Section 447.271 implements section 1903(i)(3) of the Act, which requires that payments for inpatient hospital services not exceed the hospital's customary charges.
(e) Section 447.280 implements section 1913(b) of the Act, which concerns reimbursement for long-term care services furnished by swing-bed hospitals.
For the purposes of this subpart—
(a) The plan must provide that the requirements of this subpart are met.
(b) The plan must specify comprehensively the methods and standards used by the agency to set payment rates in a manner consistent with § 430.10 of this chapter.
(c) If the agency chooses to apply the cost limits established under Medicare (see § 413.30 of this chapter) on an individual provider basis, the plan must specify this requirement.
(a)
(b)
(1)
(ii) With respect to inpatient hospital services—
(A) The methods and standards used to determine payment rates take into account the situation of hospitals which serve a disproportionate number of low income patients with special needs;
(B) If a State elects in its State plan to cover inappropriate level of care services (that is, services furnished to hospital inpatients who require a lower covered level of care such as skilled nursing or intermediate care services) under conditions similar to those described in section 1861(v)(1)(G) of the Act, the methods and standards used to determine payment rates must specify that the payments for this type of care must be made at rates lower than those for inpatient hospital level of care services, reflecting the level of care actually received, in a manner consistent with section 1861(v)(1)(G) of the Act; and
(C) The payment rates are adequate to assure that recipients have reasonable access, taking into account geographic location and reasonable travel time, to inpatient hospital services of adequate quality.
(iii) With respect to nursing facility services—
(A) Except for preadmission screening for individuals with mental illness and mental retardation under § 483.20(f) of this Chapter, the methods and standards used to determine payment rates take into account the costs of complying with the requirements of part 483 subpart B of this chapter;
(B) The methods and standards used to determine payment rates provide for an appropriate reduction to take into account the lower costs (if any) of the facility for nursing care under a waiver of the requirement in § 483.30(c) of this Chapter to provide licensed nurses on a 24-hour basis;
(C) The State establishes procedures under which the data and methodology used in establishing payment rates are made available to the public.
(2)
(c)
(d)
(1) For transfers on or after July 18, 1984 but before October 1, 1985, the State's methods and standards must provide that payment rates can reasonably be expected not to increase in the aggregate, solely as the result of a change in ownership, more than payments would increase under Medicare under §§ 413.130, 413.134, 413.153 and 413.157 of this chapter, insofar as these sections affect payment for depreciation, interest on capital indebtedness, return on equity capital (if applicable), acquisition costs for which payments were previously made to prior owners, and the recapture of depreciation.
(2) For transfers on or after October 1, 1985, the State's methods and standards must provide that the valuation of capital assets for purposes of determining payment rates for NFs and ICFs/MR is not to increase (as measured from the date of acquisition by the seller to the date of the change of
(i) One-half of the percentage increase (as measured from the date of acquisition by the seller to the date of the change of ownership, or, if necessary, as extrapolated retrospectively by the Secretary) in the Dodge construction index applied in the aggregate with respect to those facilities that have undergone a change of ownership during the fiscal year; or
(ii) One-half of the percentage increase (as measured from the date of acquisition by the seller to the date of the change of ownership) in the Consumer Price Index for All Urban Consumers (CPI-U) (United States city average) applied in the aggregate with respect to those facilities that have undergone a change of ownership during the fiscal year.
(e)
(f)
(g)
(h)
(i)
The Medicaid agency must submit, with the assurances described in § 447.253(a), the following information:
(a) The amount of the estimated average proposed payment rate for each type of provider (hospital, ICF/MR, or nursing facility), and the amount by which that estimated average rate increased or decreased relative to the average payment rate in effect for each type or provider for the immediately preceding rate period;
(b) An estimate of the short-term and, to the extent feasible, long-term effect the change in the estimated average rate will have on—
(1) The availability of services on a Statewide and geographic area basis;
(2) The type of care furnished;
(3) The extent of provider participation; and
(4) The degree to which costs are covered in hospitals that serve a disproportionate number of low income patients with special needs.
(a)
(2) In the case of State plan and plan amendment changes in payment methods and standards, CMS bases its approval on the acceptability of the Medicaid agency's assurances that the requirements of § 447.253 have been met, and the State's compliance with the other requirements of this subpart.
(b)
(c)
FFP is not available for a State's expenditures for hospital inpatient or long-term care facility services that are in excess of the amounts allowable under this subpart.
(a) The agency may not pay a provider more for inpatient hospital services under Medicaid than the provider's customary charges to the general public for the services.
(b) [Reserved]
(a)
(1) State government operated facilities (that is, all facilities that are operated by the State) as defined at § 433.50(a) of this chapter.
(2) Non-State government operated facilities (that is, all governmentally operated facilities that are not operated by the State) as defined at § 433.50(a) of this chapter.
(3) Privately operated facilities, that is, all facilities that are not operated by a unit of government as defined at § 433.50(a) of this chapter.
(b)
(2) For State government operated facilities and for non-State government operated facilities, upper payment limit refers to the individual health care provider's Medicaid cost as defined at § 447.206.
(3) Except as provided in paragraph (c) of this section, aggregate Medicaid payments to the group of privately operated facilities described in paragraph (a) of this section may not exceed the upper payment limit described in paragraph (b)(1) of this section.
(4) Except as provided in paragraph (c) of this section, Medicaid payments to State government operated facilities and non-State government operated facilities must not exceed the individual health care provider's Medicaid cost as documented in accordance with § 447.206.
(c)
(2)
(i) The aggregate DSH limit using the Federal share of the DSH limit under section 1923(f) of the Act.
(ii) The hospital-specific DSH limit in section 1923(g) of the Act.
(iii) The aggregate DSH limit for institutions for mental disease (IMDs) under section 1923(h) of the Act.
(3) The limitation in paragraph (b) of this section does not apply to payments authorized by Sections 701(d) and 705 of the Benefits Improvement Protection Act of 2000 (BIPA).
(d)
(1) For State government operated and non-State government operated hospitals, nursing facilities and ICFs/MR “ Medicaid State plan rate year 2008.
(2) For all other facilities—March 13, 2001.
(e)
(i)
(ii)
(iii)
(2)
(ii) A State with an approved State plan amendment payment provision effective on one of the following dates and that makes payments that exceed the upper payment limit described in paragraph (b) of this section to providers described in paragraphs (a)(2) and (a)(3) of this section may follow the respective transition schedule:
(A) For State plan provisions that are effective after September 30, 1999 and were approved before January 22, 2001, payments may exceed the upper payment limit in paragraph (b) of this section until September 30, 2002.
(B) For approved plan provisions that are effective after October 1, 1992 and before October 1, 1999, payments during the transition period may not exceed the following—
(
(
(
(
(C) For approved plan provisions that are effective on or before October 1, 1992, payments during the transition period may not exceed the following:
(
(
(
(
(
(
(
(D) For State plan provisions that were effective after September 30, 1999, submitted to CMS before March 13, 2001, and approved by CMS after January 21, 2001, payments may exceed the limit in paragraph (b) of this section until the later of November 5, 2001, or 1 year from the approved effective date of the State plan provision.
(iii) When State FY 2003 begins after September 30, 2002, the reduction schedule in paragraphs (e)(2)(ii)(C)(
(iv) If a State meets the criteria in paragraph (e)(2)(ii) of this section and its State plan amendment expires before the end of the applicable transition period, the State may continue making payments that exceed the UPL described in paragraph (b) of this section in accordance with the applicable transition schedule described in paragraph (e)(2)(ii) of this section.
(v) A State with an approved State plan amendment payment provision that makes payments up to 150 percent of the UPL described in paragraph (b)(1) of this section to providers described in paragraph (a)(2) of this section does not qualify for a transition period.
(f)
(1) The total Medicaid payments made to each facility for services furnished during the entire State fiscal year.
(2) A reasonable estimate of the amount that would be paid for the services furnished by the facility under Medicare payment principles.
(a)
(1) Provide for payment at the average rate per patient day paid to NFs, as applicable, for routine services furnished during the previous calendar year; or
(2) Meet the State plan and payment requirements described in this subpart, as applicable.
(b)
(a) The provisions of this section apply to the 50 States and the District of Columbia, but not to any State whose entire Medicaid program is operated under a waiver granted under section 1115 of the Act.
(b) For the period January 1, 1992 through September 30, 1992, FFP is available for aggregate payments to hospitals that serve a disproprotionate number of low-income patients with special needs only if the payments are made in accordance with sections 1902(a)(13)(A) and 1923 of the Act, and with one of the following:
(1) An approved State plan in effect as of September 30, 1991.
(2) A State plan amendment submitted to CMS by September 30, 1991.
(3) A State plan amendment, or modification thereof, submitted to CMS between October 1, 1991 and November 26, 1991, if the amendment, or modification thereof, was intended to limit the State's definition of disproportionate share hospitals to those hospitals with Medicaid inpatient utilization rates or low-income utilization rates (as defined in section 1923 (b) of the Act) at or above the statewide arithmetic mean.
(4) A methodology for disproportionate share hospital payments that was established and in effect as of September 30, 1991, or in accordance with a State law enacted or State regulation adopted as of September 30, 1991.
(5) A State plan amendment submitted to CMS by September 30, 1992 that increases aggregate disproportionate share hospitals payments in order to meet the minimum payment adjustments required by section 1923(c)(1) of the Act. The minimum payment adjustment is the amount required by the Medicare methodology described in section 1923(c)(1) of the Act for those hospitals that satisfy the minimum Federal definition of a disproportionate share hospital in section 1923(b) of the Act.
(6) A State plan amendment submitted to CMS by September 30, 1992 that provides for a redistribution of
(7) A State plan amendment submitted to CMS by September 30, 1992 that provides for a reduction in disproportionate share hospital payments.
(a)
(b)
(c)
(d)
(2) If CMS determines that at any time a State has exceeded its final DSH allotment for a Federal fiscal year, FFP attributable to the excess DSH expenditures will be disallowed.
(3) If a State's actual DSH expenditures applicable to a Federal fiscal year are less than its final State DSH allotment for that Federal fiscal year, the State is permitted, to the extent allowed by its approved State plan, to make additional DSH expenditures applicable to that Federal fiscal year up to the amount of its final DSH allotment for that Federal fiscal year.
(e)
(i) A preliminary national DSH expenditure target for the Federal fiscal year; and
(ii) A preliminary DSH allotment for each State for the Federal fiscal year.
(2) The final national DSH expenditure target and State DSH allotments will be published in the
(a)
(i) The total amount of the State's projected DSH payments for Federal fiscal year 1992 under the State plan applicable to Federal fiscal year 1992, calculated in accordance with paragraph (a)(2) of this section; or
(ii) $1,000,000.
(2) In calculating the State's DSH payments applicable to Federal fiscal year 1992, CMS will derive amounts from payments applicable to the period of October 1, 1991, through September 30, 1992, under State plans or plan amendments that meet the requirements specified in § 447.296(b). The calculation will not include—
(i) DSH payment adjustments made by the State applicable to the period October 1, 1991 through December 31, 1991 under State plans or plan amendments that do not meet the criteria described in § 447.296; and
(ii) Retroactive DSH payments made in 1992 that are not applicable to Federal fiscal year 1992.
(3) CMS will calculate a percentage for each State by dividing the DSH base allotment by the total unadjusted medical assistance expenditures, excluding administrative costs, made during Federal fiscal year 1992. On the basis of this percentage, CMS will classify each State as a “high-DSH” or “low-DSH” State.
(i) If the State's base allotment exceeded 12 percent of its total unadjusted medical assistance expenditures made under the State plan in Federal fiscal year 1992, CMS will classify the State as a “high-DSH” State.
(ii) If the State's base allotment was 12 percent or less of its total unadjusted medical assistance expenditures made under the State plan in Federal fiscal year 1992, CMS will classify the State as a “low-DSH” State.
(b)
(2) For high-DSH States, the dollar amount of DSH payments in Federal fiscal year 1993 may not exceed the dollar amount of DSH payments applicable to Federal fiscal year 1992 (that is, the State base allotment).
(c)
(1) For low-DSH States, CMS will calculate the DSH allotment for each Federal fiscal year by increasing the prior year's State DSHs allotment by—
(i) State growth, as specified in paragraph (d) of this section; and
(ii) A supplemental amount, if applicable, as described in paragraph (e) of this section.
(2) For high-DSH States, the dollar amount of DSH payments applicable to any Federal fiscal year may not exceed the dollar amount of payments applicable to Federal fiscal year 1992 (that is, the State base allotment). This payment limitation will apply until the Federal fiscal year in which the State's DSH payments applicable to that Federal fiscal year, expressed as a percentage of the State's total unadjusted medical assistance expenditures in that Federal fiscal year, equal 12 percent or less. When a high-DSH State's percentage equals 12 percent or less, the State will be reclassified as a low-DSH State.
(d)
(i) The growth factor that is CMS's projected percentage increase in the State's total unadjusted medical assistance expenditures (including administrative costs) relative to the corresponding amount in the previous year; and
(ii) The State's prior year DSH allotment.
(2) If the growth factor is zero or is negative, the State growth is zero.
(3) If a low-DSH State experiences a level of negative growth to the extent that its previous Federal fiscal year's DSH allotment would be more than 12 percent of its current Federal fiscal year's total unadjusted medical assistance expenditures (excluding administrative costs), the low-DSH State's previous year's DSH allotment will be reduced to the extent necessary to maintain the individual low-DSH State's 12-
(e)
(1) A supplemental amount is the State's share of a pool of money (referred to as a redistribution pool).
(2) CMS will calculate the redistribution pool for the appropriate Federal fiscal year by subtracting from the projected national DSH expenditure target the following:
(i) The total of the State DSH base allotments for all high-DSH States;
(ii) The total of the previous year's State DSH allotments for all low-DSH States;
(iii) The State growth amount for all low-DSH States; and
(iv) The total amount of additional DSH payment adjustments made in order to meet the minimum payment adjustments required under section 1923(c)(l) of the Act, which are made in accordance with § 447.296(b)(5).
(3) CMS will determine the percent of the redistribution pool for each low-DSH State on the basis of each State's relative share of the total unadjusted medical assistance expenditures for the Federal fiscal year compared to the total unadjusted medical assistance expenditures for the Federal fiscal year projected to be made by all low-DSH States. The percent of the redistribution pool that each State will receive is equal to the State's total unadjusted medical assistance expenditures divided by the total unadjusted medical assistance expenditures for all low-DSH States.
(4) CMS will not provide any low-DSH State a supplemental amount that would result in the State's total DSH allotment exceeding 12 percent of its projected total unadjusted medical assistance expenditures. CMS will reallocate any supplemental amounts not allocated to States because of this 12-percent limitation to other low-DSH States in accordance with the percentage determined in paragraph (e)(3) of this section.
(5) CMS will not reallocate to low-DSH States the difference between any State's actual DSH expenditures applicable to a Federal fiscal year and its State DSH allotment applicable to that Federal fiscal year. Thus, any unspent DSH allotment may not be reallocated.
(f)
(a) Beginning with the first quarter of Federal fiscal year 1993, each State must submit to CMS the quarterly aggregate amount of its disproportionate share hospital payments made to each individual public and private provider or facility. States' reports must present a complete, accurate, and full disclosure of all of their DSH programs and expenditures.
(b) Each State must report the aggregate information specified under paragraph (a) of this section on a quarterly basis in accordance with procedures established by CMS.
(c) Beginning with each State's Medicaid State plan rate year 2005, for each Medicaid State plan rate year, the State must submit to CMS, at the same time as it submits the completed audit required under § 455.204, the following information for each DSH hospital to which the State made a DSH payment in order to permit verification of the appropriateness of such payments:
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
(13)
(14)
(15)
(16)
(17)
(18) States must report DSH payments made to all hospitals under the authority of the approved Medicaid State plan. This includes both in-State and out-of-State hospitals. For out-of-State hospitals, States must report, at a minimum, the information identified in § 447.299(c)(1) through (c)(6), (c)(8), (c)(9) and (c)(17).
(d) Each State must maintain, in readily reviewable form, supporting documentation that provides a detailed description of each DSH program, the legal basis of each DSH program, and the amount of DSH payments made to each individual public and private provider or facility each quarter. This information must be made available to Federal reviewers upon request.
(e) If a State fails to comply with the reporting requirements contained in this section, future grant awards will be reduced by the amount of FFP CMS estimates is attributable to the expenditures made to the disproportionate share hospitals as to which the State has not reported properly, until such time as the State complies with the reporting requirements. Deferrals and/or disallowances of equivalent amounts may also be imposed with respect to quarters for which the State has failed to report properly. Unless otherwise prohibited by law, FFP for those expenditures will be released when the State complies with all reporting requirements.
In this subpart, § 447.302 through § 447.325 and § 447.361 implement section 1902(a)(30) of the Act, which requires that payments be consistent with efficiency, economy and quality of care. Section 447.371 implements section 1902(a)(15) of the Act, which requires that the State plan provide for payment for rural health clinic services in accordance with regulations prescribed by the Secretary.
A State plan must provide that the requirements of this subpart are met.
(a) The Medicaid agency must not pay more than the upper limits described in this subpart.
(b) In the case of payments made under the plan for deductibles and coinsurance payable on an assigned Medicare claim for noninstitutional services, those payments may be made only up to the reasonable charge under Medicare.
(c) FFP is not available for a State's expenditures for services that are in excess of the amounts allowable under this subpart.
The Secretary may waive any limitation on reimbursement imposed by subpart F of this part for experiments conducted under section 402 of Pub. L. 90-428, Incentives
(a)
(1) State government operated facilities (that is, all facilities that are operated by the State) as defined at § 433.50(a) of this chapter.
(2) Non-State government operated facilities (that is, all governmentally operated facilities that are not operated by the State) as defined at § 433.50(a) of this chapter.
(3) Privately operated facilities that is, all facilities that are not operated by a unit of government as defined at § 433.50(a) of this chapter.
(b)
(2) For State government operated facilities and for non-State government operated facilities, upper payment limit refers to the individual health care provider's Medicaid cost as defined at § 447.206.
(3) Except as provided in paragraph (c) of this section, aggregate Medicaid payments to the group of privately operated facilities within one of the categories described in paragraph (a) of this section may not exceed the upper payment limit described in paragraph (b)(1) of this section.
(4) Except as provided in paragraph (c) of this section, Medicaid payments to State government operated facilities and non-State government operated facilities must not exceed the individual health care provider's Medicaid cost as documented in accordance with § 447.206.
(c)
(2)
(i) The aggregate DSH limit using the Federal share of the DSH limit under section 1923(f) of the Act.
(ii) The hospital-specific DSH limit in section 1923(g) of the Act.
(iii) The aggregate DSH limit for institutions for mental disease (IMDs) under section 1923(h) of the Act.
(3) The limitation in paragraph (b) of this section does not apply to payments authorized by Sections 701(d) and 705 of the Benefits Improvement Protection Act of 2000 (BIPA).
(d)
(1) For State government operated and non-State government operated hospitals—Medicaid State plan rate year 2008.
(2) For State government operated and non-State government operated clinics—Medicaid State plan rate year 2009.
(3) For all other facilities—March 13, 2001.
(e)
(i)
(ii)
(iii)
(2)
(ii) A State with an approved State plan amendment payment provision effective on one of the following dates and that makes payments that exceed the upper payment limit described in paragraph (b) of this section to providers described in paragraph (a) of this section may follow the respective transition schedule:
(A) For State plan provisions that are effective after September 30, 1999 and were approved before January 22, 2001, payments may exceed the upper payment limit in paragraph (b) of this section until September 30, 2002.
(B)
(
(
(
(
(C)
(
(
(
(
(
(
(
(D) For State plan provisions that were effective after September 30, 1999, submitted to CMS before March 13, 2001, and approved by CMS after January 21, 2001, payments may exceed the limit in paragraph (b) of this section until the later of November 5, 2001, or 1 year from the approved effective date of the State plan provision.
(iii) When State FY 2003 begins after September 30, 2002, the reduction schedule in paragraphs (e)(2)(ii)(C)(1) through (e)(2)(ii)(C)(7) will begin on State FY 2003.
(iv) If a State meets the criteria in paragraph (e)(2)(ii) of this section and its State plan amendment expires before the end of the applicable transition period, the State may continue making payments that exceed the UPL described in paragraph (b) of this section in accordance with the applicable transition schedule described in paragraph (e)(2)(ii) of this section.
(v) A State with an approved State plan amendment payment provision that makes payments up to 150 percent of the UPL described in paragraph (b)(1) of this section to providers described in paragraph (a)(2) of this section does not qualify for a transition period.
(f)
(1) The total Medicaid payments made to each facility for services furnished during the entire State fiscal year.
(2) A reasonable estimate of the amount that would be paid for the services furnished by the facility under Medicare payment principles.
The agency may pay the customary charges of the provider but must not pay more than the prevailing charges in the locality for comparable services under comparable circumstances.
Under a nonrisk contract, Medicaid payments to the contractor may not exceed—
(a) What Medicaid would have paid, on a fee-for-service basis, for the services actually furnished to recipients: plus
(b) The net savings of administrative costs the Medicaid agency achieves by contracting with the plan instead of purchasing the services on a fee-for-service basis.
The agency must pay for rural health clinic services, as defined in § 440.20(b) of this subchapter, and for other ambulatory services furnished by a rural health clinic, as defined in § 440.20(c) of this subchapter, as follows:
(a) For provider clinics, the agency must pay the reasonable cost of rural health clinic services and other ambulatory services on the basis of the cost reimbursement principles in part 413 of this chapter. For purposes of this section, a provider clinic is an integral part of a hospital, skilled nursing facility, or home health agency that is participating in Medicare and is licensed, governed, and supervised with other departments of the facility.
(b) For clinics other than provider clinics that do not offer any ambulatory services other than rural health clinic services, the agency must pay for rural health clinic services at the reasonable cost rate per visit determined by a Medicare carrier under §§ 405.2426 through 405.2429 of this chapter.
(c) For clinics other than provider clinics that do offer ambulatory services other than rural health clinic services, the agency must pay for the other ambulatory services by one of the following methods:
(1) The agency may pay for other ambulatory services and rural health clinic services at a single rate per visit that is based on the cost of all services furnished by the clinic. The rate must be determined by a Medicare carrier under §§ 405.2426 through 405.2429 of this chapter.
(2) The agency may pay for other ambulatory services at a rate set for each service by the agency. The rate must not exceed the upper limits in this subpart. The agency must pay for rural health clinic services at the Medicare reimbursement rate per visit, as specified in § 405.2426 of this chapter.
(3) The agency may pay for dental services at a rate per visit that is based on the cost of dental services furnished by the clinic. The rate must be determined by a Medicare carrier under §§ 405.2426 through 405.2429 of this chapter. The agency must pay for ambulatory services other than dental services under paragraph (c) (1) or (2) of this section.
(d) For purposes of paragraph (c) (1) and (3) of this section, “visit” means a face-to-face encounter between a clinic patient and any health professional whose services are reimbursed under the State plan. Encounters with more than one health professional, and multiple encounters with the same health professional, that take place on the same day and at a single location constitute a single visit, except when the patient, after the first encounter, suffers illness or injury requiring additional diagnosis or treatment.
(a)
(1) Interprets those provisions of section 1927 of the Act that set forth requirements for drug manufacturers' calculating and reporting average manufacturer prices (AMPs) and that set upper payment limits for covered outpatient drugs.
(2) Implements section 1903(i)(10) of the Act with regard to the denial of Federal financial participation (FFP) in expenditures for certain physician-administered drugs.
(3) Implements section 1902(a)(54) of the Act with regard to a State plan that provides covered outpatient drugs.
(b)
(1) Is incurred at the point of sale or service and pays for costs in excess of the ingredient cost of a covered outpatient drug each time a covered outpatient drug is dispensed;
(2) Includes only pharmacy costs associated with ensuring that possession of the appropriate covered outpatient drug is transferred to a Medicaid recipient. Pharmacy costs include, but are not limited to, reasonable costs associated with a pharmacist's time in checking the computer for information about an individual's coverage, performing drug utilization review and preferred drug list review activities, measurement or mixing of the covered outpatient drug, filling the container, beneficiary counseling, physically providing the completed prescription to the Medicaid beneficiary, delivery, special packaging, and overhead associated with maintaining the facility and equipment necessary to operate the pharmacy; and
(3) Does not include administrative costs incurred by the State in the operation of the covered outpatient drug benefit including systems costs for interfacing with pharmacies.
(1) Is engaged in the production, preparation, propagation, compounding, conversion, or processing of covered outpatient drug products, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis; or
(2) Is engaged in the packaging, repackaging, labeling, relabeling, or distribution of covered outpatient drug products and is not a wholesale distributor of drugs or a retail pharmacy licensed under State law.
(3) With respect to authorized generic products, the term “manufacturer” will also include the original holder of the NDA.
(4) With respect to drugs subject to private labeling arrangements, the term “manufacturer” will also include the entity that does not possess legal title to the NDC.
(1) Is rated as therapeutically equivalent. For the list of drug products rated as therapeutically equivalent, see the FDA's most recent publication of “Approved Drug Products with Therapeutic Equivalence Evaluations” which is available at
(2) Is pharmaceutically equivalent and bioequivalent, as determined by the FDA; and
(3) Is sold or marketed in the State during the rebate period as follows:
(i) A drug product is considered sold or marketed in a State if it appears in a published national listing of average wholesale prices, selected by the Secretary, provided that the listed product is generally available to the public through retail pharmacies in that State.
(ii) A covered outpatient drug is not subject to the FUL for a rebate period if it is not a multiple source drug in the State for that rebate period.
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(1) Sales to wholesalers, except for those sales that can be identified with adequate documentation as being subsequently sold to any of the excluded entities as specified in paragraph (h) of this section;
(2) Sales to other manufacturers who act as wholesalers and do not repackage/relabel under the purchaser's NDC, including private labeling agreements;
(3) Direct and indirect sales to hospitals, where the drug is used in the outpatient pharmacy, except those sales that cannot be identified with adequate documentation as being used in the outpatient pharmacy for outpatient use (for example hospital outpatient department, clinic, or affiliated entity);
(4) Sales at nominal prices to any entity except a covered entity described in section 340B(a)(4) of the Public Health Service Act (PHSA), an intermediate care facility for the mentally retarded (ICF/MR) providing services as set forth in § 440.150 of this chapter, or a State-owned or operated nursing facility providing services as set forth in § 440.155 of this chapter;
(5) Sales to retail pharmacies including discounts or other price concessions that adjust prices either directly or indirectly on sales of drugs to the retail pharmacy class of trade;
(6) Sales including discounts, rebates, or other price concessions provided to pharmacy benefit managers (PBMs) for their mail order pharmacy purchases;
(7) Sales directly to patients;
(8) Sales to outpatient facilities (for example, clinics, surgical centers, ambulatory care centers, dialysis centers, and mental health centers);
(9) Sales to mail order pharmacies;
(10) Sales to home infusion providers;
(11) Sales to specialty pharmacies;
(12) Sales to home health care providers;
(13) Sales to physicians;
(14) Rebates, discounts, or other price concessions (other than rebates under section 1927 of the Act or as otherwise specified in the statute or regulations) associated with sales of drugs provided to the retail pharmacy class of trade; and
(15) Sales of drugs reimbursed by third party payers including the Medicare Part D Program, a Medicare Advantage prescription drug plan (MA-PD), a Qualified Retiree Prescription Drug Plan under section 1860D-22(a)(2) of the Act, State Children's Health Insurance Program (SCHIP), State pharmaceutical assistance programs (SPAPs), health maintenance organizations (HMOs) (including managed care organizations (MCOs)) that do not purchase or take possession of drugs, TRICARE Retail Pharmacy Program (TRRx), and Medicaid Programs that are associated with sales of drugs provided to the retail pharmacy class of trade (except for rebates under section 1927 of the Act or as otherwise specified in the statute or regulations).
(h)
(1) Any prices on or after October 1, 1992, to the Indian Health Service (IHS), the Department of Veterans Affairs (DVA), a State home receiving funds under 38 U.S.C. 1741, the Department of Defense (DoD), the Public Health Service (PHS), or a covered entity described in section 1927(a)(5)(B) of the Act (including inpatient prices charged to hospitals described in section 340B(a)(4)(L) of the PHSA);
(2) Any prices charged under the Federal Supply Schedule (FSS) of the General Services Administration (GSA);
(3) Any depot prices (including TRICARE) and single award contract prices, as defined by the Secretary, of any agency of the Federal Government;
(4) Direct and indirect sales to hospitals, where the drug is used in the inpatient setting or in the outpatient pharmacy for outpatient use where the sales cannot be identified with adequate documentation;
(5) Sales to HMOs (including MCOs, and HMO/MCO-operated pharmacies) that purchase or take possession of drugs;
(6) Sales to long-term care facilities, including nursing facility pharmacies, contract pharmacies for the nursing facility where these sales can be identified with adequate documentation, and other entities where the drugs are dispensed through a nursing facility pharmacy, such as assisted living facilities;
(7) Sales to hospices (inpatient and outpatient);
(8) Sales to veterinarians;
(9) Sales to prisons;
(10) Sales outside the 50 States and the District of Columbia;
(11) Sales to State, county, and municipal entities;
(12) Sales to patient assistance programs;
(13) Sales to wholesalers where the drug is distributed to the non-retail pharmacy class of trade;
(14) Sales to wholesalers or distributors where the drug is relabeled under the wholesalers' or distributors' NDC number;
(15) Manufacturer coupons redeemed by a consumer, agent, pharmacy or another entity acting on behalf of the manufacturer, but only to the extent that the full value of the coupon is passed on to the consumer and the pharmacy, agent, or other entity does not receive any price concession;
(16) Manufacturer vouchers;
(17) Manufacturer-sponsored drug discount card programs;
(18) Free goods, not contingent upon any purchase requirement;
(19) Bona fide service fees;
(20) Customary prompt pay discounts extended to wholesalers;
(21) Returned or replaced goods when accepted or replaced in good faith;
(22) Discounts, rebates, or other price concessions to PBMs, except for their mail order pharmacy's purchases.
(23) Associated rebates, discounts, or other price concessions to third party payers including the Medicare Part D Program, an MA-PD, Qualified Retiree Prescription Drug Plan under section 1860D-22(a)(2) of the Act, SCHIP, SPAPs, HMOs (including MCOs that do not take possession of drugs) the TRICARE Retail Pharmacy Program, and Medicaid Programs; and
(24) Rebates under the national rebate agreement or a CMS-authorized State supplemental rebate agreement paid to State Medicaid Agencies under section 1927 of the Act.
(i)
(2) Quarterly AMP is calculated as a weighted average of monthly AMPs in the quarter.
(3) The manufacturer must adjust the AMP for a rebate period if cumulative discounts, rebates, or other arrangements subsequently adjust the prices actually realized.
(a)
(b) For purposes of this section,
(c)
(1) Prices to wholesalers;
(2) Prices to any retailer, including rebates, discounts or other price concessions that adjust prices either directly or indirectly on sales of drugs;
(3) Prices to providers (for example, hospitals, HMOs/MCOs, physicians, nursing facilities, and home health agencies);
(4) Prices available to non-profit entities;
(5) Prices available to governmental entities within the United States;
(6) Prices of authorized generic drugs, sold by the primary manufacturer in accordance with § 447.506(d) of this subpart;
(7) Prices of sales directly to patients;
(8) Prices available to mail order pharmacies;
(9) Prices available to outpatient clinics;
(10) Prices to other manufacturers who act as wholesalers and do not repackage/relabel under the purchaser's NDC, including private labeling agreements; and
(11) Prices to entities that repackage/relabel under the purchaser's NDC, including private labeling agreements, if that entity also is an HMO or other non-excluded entity.
(d)
(1) Any prices on or after October 1, 1992, charged to the IHS, the DVA, a State home receiving funds under 38 U.S.C. 1741, the DoD, the PHS, or a covered entity described in section 1927(a)(5)(B) of the Act (including inpatient prices charged to hospitals described in section 340B(a)(4)(L) of the PHSA);
(2) Any prices charged under the FSS of the GSA;
(3) Any prices provided to a designated SPAP;
(4) Any depot prices and single award contract prices, as defined by the Secretary, of any agency of the Federal Government;
(5) Any prices charged which are negotiated by a prescription drug plan under Part D of title XVIII, by any MA-PD plan under Part C of such title with respect to covered Part D drugs, or by a Qualified Retiree Prescription Drug Plan (as defined in section 1860D-22(a)(2) of the Act) with respect to such drugs on behalf of individuals entitled to benefits under Part A or enrolled under Part B of Medicare;
(6) Rebates under the national rebate agreement or a CMS-authorized supplemental rebate agreement paid to State Medicaid Agencies under section 1927 of the Act;
(7) Prices negotiated under a manufacturer-sponsored drug discount card program;
(8) Manufacturer coupons redeemed by a consumer, agent, pharmacy or another entity acting on behalf of the manufacturer; but only to the extent that the full value of the coupon is passed on to the consumer and the pharmacy, agent, or other entity does not receive any price concession;
(9) Goods provided free of charge under a manufacturer's patient assistance programs;
(10) Free goods, not contingent upon any purchase requirement;
(11) Nominal prices to certain entities as set forth in § 447.508 of this subpart;
(12) Bona fide service fees; and
(13) PBM rebates, discounts, or other price concessions except their mail order pharmacy's purchases or where such rebates, discounts, or other price concessions are designed to adjust prices at the retail or provider level.
(e)
(2) Best price must be determined on a unit basis without regard to package size, special packaging, labeling or identifiers on the dosage form or product or package, and must not take into account prices that are nominal in amount as described in § 447.508 of this subpart.
(3) The manufacturer must adjust the best price for a rebate period if cumulative discounts, rebates, or other arrangements subsequently adjust the prices available from the manufacturer.
(a)
(b)
(c)
(a)
(1) A covered entity described in section 340B(a)(4) of the PHSA;
(2) An ICF/MR providing services as set forth in § 440.150 of this chapter; or
(3) A State-owned or operated nursing facility providing services as set forth in § 440.155 of this chapter.
(b)
(a)
(1) AMP, calculated in accordance with § 447.504 of this subpart;
(2) Best price, calculated in accordance with § 447.505 of this subpart;
(3) Customary prompt pay discounts, which shall be reported as an aggregate dollar amount for each covered outpatient drug at the nine-digit NDC level, provided to all wholesalers in the rebate period; and
(4) Prices that fall within the nominal price exclusion, which shall be reported as an aggregate dollar amount and shall include all sales of single source and innovator multiple source drugs to the entities listed in § 447.508(a) of this subpart for the rebate period.
(b)
(2) A manufacturer must report revisions to AMP, except when the revision would be solely as a result of data pertaining to lagged price concessions.
(c)
(2)
(ii) A manufacturer may choose to recalculate base date AMP on a product-by-product basis.
(iii) A manufacturer must use actual and verifiable pricing records in recalculating base date AMP.
(d)
(2)
(3)
(4)
(5)
(e)
(1) The manufacturer's chief executive officer (CEO);
(2) The manufacturer's chief financial officer (CFO);
(3) An individual other than a CEO or CFO, who has authority equivalent to a CEO or a CFO; or
(4) An individual with the directly delegated authority to perform the certification on behalf of an individual described in subsections (1) through (3).
(f)
(2) A manufacturer must retain records beyond the ten-year period if both of the following circumstances exist:
(i) The records are the subject of an audit or of a government investigation related to pricing data that are used in AMP, best price, customary prompt pay discounts, or nominal prices of which the manufacturer is aware.
(ii) The audit findings or investigation related to the AMP, best price, customary prompt pay discounts, or nominal price have not been resolved.
(g)
(a)
(b)
(1) EAC plus reasonable dispensing fees established by the agency; or
(2) Providers' usual and customary charges to the general public.
(c)
(2) The agency must decide what certification form and procedure are used.
(3) A checkoff box on a form is not acceptable but a notation like “brand necessary” is allowable.
(4) The agency may allow providers to keep the certification forms if the forms will be available for inspection by the agency or HHS.
(a)
(i) The FDA has rated two or more drug products as therapeutically and pharmaceutically equivalent in its most current edition of “Approved Drug Products with Therapeutic Equivalence Evaluations” (including supplements or in successor publications), regardless of whether all such formulations are rated as such and only such formulations shall be used when determining any such upper limit.
(ii) At least two suppliers meet the criteria in paragraph (a)(1)(i) of this section.
(2) CMS publishes the list of multiple source drugs for which upper limits have been established and any revisions to the list in Medicaid Program issuances.
(b)
(c)
(1) The AMP of a terminated NDC will not be used to set the Federal upper limit (FUL) beginning with the first day of the month after the actual termination date reported by the manufacturer to CMS.
(2) Except as set forth in paragraph (c)(3) of this section, the AMP of the lowest priced therapeutically and pharmaceutically equivalent drug that is not less than 40 percent of the next highest AMP will be used to establish the FUL.
(3) When the FUL group includes only the brand name drug and the first new generic or authorized generic drug which has entered the market, the criteria in paragraph (c)(2) of this section will not apply.
The upper limits for payment for prescribed drugs in this subpart also apply to payment for drugs provided as part of skilled nursing facility services and intermediate care facility services and under prepaid capitation arrangements.
(a)
(b)
(1)
(i) In the aggregate, its Medicaid expenditures for multiple source drugs, identified and listed in accordance with § 447.514(a) of this subpart, are in accordance with the upper limits specified in § 447.514(b) of this subpart; and
(ii) In the aggregate, its Medicaid expenditures for all other drugs are in accordance with § 447.512 of this subpart.
(2)
(c)
(a) No FFP is available for physician-administered drugs for which a State has not required the submission of claims using codes that identify the drugs sufficiently for the State to bill a manufacturer for rebates.
(1) As of January 1, 2006, a State must require providers to submit claims for single source, physician-administered drugs using Healthcare Common Procedure Coding System codes or NDC numbers in order to secure rebates.
(2) As of January 1, 2008, a State must require providers to submit claims for the 20 multiple source physician-administered drugs identified by the Secretary as having the highest
(b) As of January 1, 2007, a State must require providers to submit claims for physician-administered single source drugs and the 20 multiple source drugs identified by the Secretary using NDC numbers.
(c) A State that requires additional time to comply with the requirements of this section may apply to the Secretary for an extension.
Sec. 1102 of the Social Security Act (42 U.S.C. 1302).
This part sets forth requirements for a State fraud detection and investigation program, and for disclosure of information on ownership and control.
(a) Under the authority of sections 1902(a)(4), 1903(i)(2), and 1909 of the Social Security Act, Subpart A provides State plan requirements for the identification, investigation, and referral of suspected fraud and abuse cases. In addition, the subpart requires that the State—
(1) Report fraud and abuse information to the Department; and
(2) Have a method to verify whether services reimbursed by Medicaid were actually furnished to recipients.
(b) Subpart B implements sections 1124, 1126, 1902(a)(36), 1903(i)(2), and 1903(n) of the Act. It requires that providers and fiscal agents must agree to disclose ownership and control information to the Medicaid State agency.
(c) Subpart C implements section 1936 of the Act. It establishes the Medicaid Integrity Program under which the Secretary will promote the integrity of the program by entering into contracts with eligible entities to carry out the activities of subpart C.
As used in this part unless the context indicates otherwise—
Part 1002 of this title sets forth the following:
(a) State plan requirements for excluding providers for fraud and abuse, and suspending practitioners convicted of program-related crimes.
(b) The limitations on FFP for services furnished by excluded providers or suspended practitioners.
(c) The requirements and procedures for reinstatement after exclusion or suspension.
(d) Requirements for the establishment and operation of State Medicaid fraud control units and the rates of FFP for their fraud control activities.
A State plan must meet the requirements of §§ 455.13 through 455.23.
The Medicaid agency must have—
(a) Methods and criteria for identifying suspected fraud cases;
(b) Methods for investigating these cases that—
(1) Do not infringe on the legal rights of persons involved; and
(2) Afford due process of law; and
(c) Procedures, developed in cooperation with State legal authorities, for referring suspected fraud cases to law enforcement officials.
If the agency receives a complaint of Medicaid fraud or abuse from any source or identifies any questionable practices, it must conduct a preliminary investigation to determine whether there is sufficient basis to warrant a full investigation.
If the findings of a preliminary investigation give the agency reason to believe that an incident of fraud or abuse has occurred in the Medicaid program, the agency must take the following action, as appropriate:
(a) If a provider is suspected of fraud or abuse, the agency must—
(1) In States with a State Medicaid fraud control unit certified under subpart C of part 1002 of this title, refer
(2) In States with no certified Medicaid fraud control unit, or in cases where no referral to the State Medicaid fraud control unit is required under paragraph (a)(1) of this section, conduct a full investigation or refer the case to the appropriate law enforcement agency.
(b) If there is reason to believe that a recipient has defrauded the Medicaid program, the agency must refer the case to an appropriate law enforcement agency.
(c) If there is reason to believe that a recipient has abused the Medicaid program, the agency must conduct a full investigation of the abuse.
A full investigation must continue until—
(a) Appropriate legal action is initiated;
(b) The case is closed or dropped because of insufficient evidence to support the allegations of fraud or abuse; or
(c) The matter is resolved between the agency and the provider or recipient. This resolution may include but is not limited to—
(1) Sending a warning letter to the provider or recipient, giving notice that continuation of the activity in question will result in further action;
(2) Suspending or terminating the provider from participation in the Medicaid program;
(3) Seeking recovery of payments made to the provider; or
(4) Imposing other sanctions provided under the State plan.
The agency must report the following fraud or abuse information to the appropriate Department officials at intervals prescribed in instructions.
(a) The number of complaints of fraud and abuse made to the agency that warrant preliminary investigation.
(b) For each case of suspected provider fraud and abuse that warrants a full investigation—
(1) The provider's name and number;
(2) The source of the complaint;
(3) The type of provider;
(4) The nature of the complaint;
(5) The approximate range of dollars involved; and
(6) The legal and administrative disposition of the case, including actions taken by law enforcement officials to whom the case has been referred.
(a) Except as provided in § 455.19, the agency must provide that all provider claims forms be imprinted in boldface type with the following statements, or with alternate wording that is approved by the Regional CMS Administrator:
(1) “This is to certify that the foregoing information is true, accurate, and complete.”
(2) “I understand that payment of this claim will be from Federal and State funds, and that any falsification, or concealment of a material fact, may be prosecuted under Federal and State laws.”
(b) The statements may be printed above the claimant's signature or, if they are printed on the reverse of the form, a reference to the statements must appear immediately preceding the claimant's signature.
As an alternative to the statements required in § 455.18, the agency may print the following wording above the claimant's endorsement on the reverse of checks or warrants payable to each provider: “I understand in endorsing or depositing this check that payment will be from Federal and State funds and that any falsification, or concealment of a material fact, may be prosecuted under Federal and State laws.”
(a) The agency must have a method for verifying with recipients whether services billed by providers were received.
(b) In States receiving Federal matching funds for a mechanized claims processing and information retrieval system under part 433, subpart C, of this subchapter, the agency must provide prompt written notice as required by § 433.116 (e) and (f).
In a State with a Medicaid fraud control unit established and certified under subpart C of this part,
(a) The agency must—
(1) Refer all cases of suspected provider fraud to the unit;
(2) If the unit determines that it may be useful in carrying out the unit's responsibilities, promptly comply with a request from the unit for—
(i) Access to, and free copies of, any records or information kept by the agency or its contractors;
(ii) Computerized data stored by the agency or its contractors. These data must be supplied without charge and in the form requested by the unit; and
(iii) Access to any information kept by providers to which the agency is authorized access by section 1902(a)(27) of the Act and § 431.107 of this subchapter. In using this information, the unit must protect the privacy rights of recipients; and
(3) On referral from the unit, initiate any available administrative or judicial action to recover improper payments to a provider.
(b) The agency need not comply with specific requirements under this subpart that are the same as the responsibilities placed on the unit under subpart D of this part.
(a)
(b)
(1) State that payments are being withheld in accordance with this provision;
(2) State that the withholding is for a temporary period, as stated in paragraph (c) of this section, and cite the circumstances under which withholding will be terminated;
(3) Specify, when appropriate, to which type or types of Medicaid claims withholding is effective; and
(4) Inform the provider of the right to submit written evidence for consideration by the agency.
(c)
(1) The agency or the prosecuting authorities determine that there is insufficient evidence of fraud or willful misrepresentation by the provider; or
(2) Legal proceedings related to the provider's alleged fraud or willful misrepresentation are completed.
This subpart implements sections 1124, 1126, 1902(a)(38), 1903(i)(2), and 1903(n) of the Social Security Act. It
(a) Disclosure by providers and fiscal agents of ownership and control information; and
(b) Disclosure of information on a provider's owners and other persons convicted of criminal offenses against Medicare, Medicaid, or the title XX services program.
(a) Any hospital, skilled nursing facility, home health agency, independent clinical laboratory, renal disease facility, rural health clinic, or health maintenance organization that participates in Medicare (title XVIII);
(b) Any Medicare intermediary or carrier; and
(c) Any entity (other than an individual practitioner or group of practitioners) that furnishes, or arranges for the furnishing of, health-related services for which it claims payment under any plan or program established under title V or title XX of the Act.
(a) Has an ownership interest totaling 5 percent or more in a disclosing entity;
(b) Has an indirect ownership interest equal to 5 percent or more in a disclosing entity;
(c) Has a combination of direct and indirect ownership interests equal to 5 percent or more in a disclosing entity;
(d) Owns an interest of 5 percent or more in any mortgage, deed of trust, note, or other obligation secured by the disclosing entity if that interest equals at least 5 percent of the value of the property or assets of the disclosing entity;
(e) Is an officer or director of a disclosing entity that is organized as a corporation; or
(f) Is a partner in a disclosing entity that is organized as a partnership.
(a) An individual, agency, or organization to which a disclosing entity has contracted or delegated some of its management functions or responsibilities of providing medical care to its patients; or
(b) An individual, agency, or organization with which a fiscal agent has entered into a contract, agreement, purchase order, or lease (or leases of real property) to obtain space, supplies,
(a)
(b)
A State plan must provide that the requirements of §§ 455.104 through 455.106 are met.
(a)
(1) The name and address of each person with an ownership or control interest in the disclosing entity or in any subcontractor in which the disclosing entity has direct or indirect ownership of 5 percent or more;
(2) Whether any of the persons named, in compliance with paragraph (a)(1) of this section, is related to another as spouse, parent, child, or sibling.
(3) The name of any other disclosing entity in which a person with an ownership or control interest in the disclosing entity also has an ownership or control interest. This requirement applies to the extent that the disclosing entity can obtain this information by requesting it in writing from the person. The disclosing entity must—
(i) Keep copies of all these requests and the responses to them;
(ii) Make them available to the Secretary or the Medicaid agency upon request; and
(iii) Advise the Medicaid agency when there is no response to a request.
(b)
(2) Any disclosing entity that is not subject to periodic survey and certification and has not supplied the information specified in paragraph (a) of this section to the Secretary within the prior 12-month period, must submit the information to the Medicaid agency before entering into a contract or agreement to participate in the program. The Medicaid agency must promptly furnish the information to the Secretary.
(3) Updated information must be furnished to the Secretary or the State
(c)
(d)
(a)
(b)
(1) The ownership of any subcontractor with whom the provider has had business transactions totaling more than $25,000 during the 12-month period ending on the date of the request; and
(2) Any significant business transactions between the provider and any wholly owned supplier, or between the provider and any subcontractor, during the 5-year period ending on the date of the request.
(c)
(2) FFP will be denied in expenditures for services furnished during the period beginning on the day following the date the information was due to the Secretary or the Medicaid agency and ending on the day before the date on which the information was supplied.
(a)
(1) Has ownership or control interest in the provider, or is an agent or managing employee of the provider; and
(2) Has been convicted of a criminal offense related to that person's involvement in any program under Medicare, Medicaid, or the title XX services program since the inception of those programs.
(b)
(2) The agency must also promptly notify the Inspector General of the Department of any action it takes on the provider's application for participation in the program.
(c)
(2) The Medicaid agency may refuse to enter into or may terminate a provider agreement if it determines that the provider did not fully and accurately make any disclosure required under paragraph (a) of this section.
(a)
(b)
(a) A program contractor, a person, or an entity employed by, or having a fiduciary relationship with, or who furnishes professional services to a program contractor will not be held to have violated any criminal law and will not be held liable in any civil action, under any law of the United States or of any State (or political subdivision thereof), by reason of the performance of any duty, function, or activity required or authorized under this subpart or under a valid contract entered into under this subpart, provided due care was exercised in that performance and the contractor has a contract with CMS under this subpart.
(b) CMS pays a contractor, a person, or an entity described in paragraph (a) of this section, or anyone who furnishes legal counsel or services to a contractor or person, a sum equal to the reasonable amount of the expenses, as determined by CMS, incurred in connection with the defense of a suit, action, or proceeding, if the following conditions are met:
(1) The suit, action, or proceeding was brought against the contractor, person or entity by a third party and relates to the contractor's, person's or entity's performance of any duty, function, or activity under a contract entered into with CMS under this subpart.
(2) The funds are available.
(3) The expenses are otherwise allowable under the terms of the contract.
CMS may enter into a contract with an entity to perform the activities described at § 455.232, if it meets the following conditions:
(a) The entity has demonstrated capability to carry out the activities described below.
(b) In carrying out such activities, the entity agrees to cooperate with the Inspector General of the Department of Health and Human Services, the Attorney General, and other law enforcement agencies, as appropriate, in the investigation and deterrence of fraud and abuse in relation to Title XIX of the Social Security Act and in other cases arising out of such activities.
(c) Maintains an appropriate written code of conduct and compliance policies that include, without limitation, an enforced policy on employee conflicts of interest.
(d) The entity complies with such conflict of interest standards as are generally applicable to Federal acquisition and procurement.
(e) The entity meets such other requirements the Secretary may impose.
The contract between CMS and a Medicaid integrity audit program contractor specifies the functions the contractor will perform. The contract may include any or all of the following functions:
(a) Review of the actions of individuals or entities furnishing items or services (whether on a fee-for-service, risk, or other basis) for which payment may be made under a State Plan approved under title XIX of the Act (or under any waiver of such plan approved under section 1115 of the Act) to determine whether fraud, waste, or abuse has occurred, is likely to occur, or whether such actions have the potential for resulting in an expenditure of funds under title XIX in a manner
(b) Auditing of claims for payment for items or services furnished, or administrative services rendered, under a State Plan under title XIX to ensure proper payments were made. This includes: cost reports, consulting contracts, and risk contracts under section 1903(m) of the Act.
(c) Identifying if overpayments have been made to individuals or entities receiving Federal funds under title XIX.
(d) Educating providers of service, managed care entities, beneficiaries, and other individuals with respect to payment integrity and quality of care.
(a) CMS awards and administers Medicaid integrity audit program contracts in accordance with acquisition regulations set forth at 48 CFR chapters 1 and 3, this subpart, and all other applicable laws and regulations. These competitive procedures and requirements for awarding Medicaid integrity audit program contracts are to be used as follows:
(1) When entering into new contracts under this section.
(2) At any other time considered appropriate by the Secretary.
(b) An entity is eligible to be awarded a Medicaid integrity audit program contract only if meets the eligibility requirements established in § 455.202, 48 CFR chapter 3, and all other applicable laws and requirements.
(a) CMS specifies the initial contract term in the Medicaid integrity audit program contract. CMS may, but is not required to, renew a Medicaid integrity audit program contract without regard to any provision of law requiring competition if the contractor has met or exceeded the performance requirements established in the current contract.
(b) CMS may renew a Medicaid integrity audit program contract without competition if all of the following conditions are met:
(1) The Medicaid integrity audit program contractor continues to meet the requirements established in this subpart.
(2) The Medicaid integrity audit program contractor meets or exceeds the performance requirements established in its current contract.
(3) It is in the best interest of the government.
(c) If CMS does not renew a contract, the contract will end in accordance with its terms. The contractor will not have a right to a hearing or judicial review regarding CMS's renewal or non-renewal decision.
(a) Offerors for Medicaid integrity audit program contracts, and Medicaid integrity audit program contractors, are subject to the following requirements:
(1) The conflict of interest standards and requirements of the Federal Acquisition Regulation organizational conflict of interest guidance, found under 48 CFR subpart 9.5.
(2) The standards and requirements that are contained in each individual contract awarded to perform activities described under section 1936 of the Act.
(b) Post-award conflicts of interest: CMS considers that a post-award conflict of interest has developed if, during the term of the contract, one of the following occurs:
(1) The contractor or any of its employees, agents, or subcontractors received, solicited, or arranged to receive any fee, compensation, gift (defined at 5 CFR 2635.203(b)), payment of expenses, offer of employment, or any other thing of value from any entity that is reviewed, audited, investigated, or contacted during the normal course of performing activities under the Medicaid integrity audit program contract.
(2) CMS determines that the contractor's activities are creating a conflict of interest.
(c) If CMS determines that a conflict of interest exists during the term of the contract, among other actions, CMS may:
(1) Not renew the contract for an additional term.
(2) Modify the contract.
(3) Terminate the contract.
(a) Review Board: CMS may establish a Conflicts of Interest Review Board to assist in resolving organizational conflicts of interest.
(b) Resolution: Resolution of an organizational conflict of interest is a determination by the contracting officer that:
(1) The conflict is mitigated.
(2) The conflict precludes award of a contract to the offeror.
(3) The conflict requires that CMS modify an existing contract.
(4) The conflict requires that CMS terminate an existing contract.
(5) It is in the best interest of the government to contract with the offeror or contractor even though the conflict of interest exists and a request for waiver is approved in accordance with 48 CFR 9.503.
This subpart implements Section 1923(j)(2) of the Act.
For the purposes of this subpart—
(a)
(2) FFP is not available in expenditures for DSH payments that are found in the independent certified audit to exceed the hospital-specific eligible uncompensated care cost limit, except as provided in paragraph (e) of this section.
(b)
(c)
(1) Approved Medicaid State plan for the Medicaid State plan rate year under audit.
(2) Payment and utilization information from the State's Medicaid Management Information System.
(3) The Medicare 2552-96 hospital cost report(s) applicable to the Medicaid State plan rate year under audit. If the Medicare 2552-96 is superseded by an alternate Medicare developed cost reporting tool during an audit year, that tool must be used for the Medicaid State plan rate year under audit.
(4) Audited hospital financial statements and hospital accounting records.
(d)
(1)
(2)
(3)
(4)
(5)
(6)
(e)
Sec. 1102 of the Social Security Act (42 U.S.C. 1302), unless otherwise noted.
(a) This part prescribes requirements concerning control of the utilization of Medicaid services including—
(1) A statewide program of control of the utilization of all Medicaid services; and
(2) Specific requirements for the control of the utilization of Medicaid services in institutions.
(3) Specific requirements for an outpatient drug use review program.
(b) The requirements in this part are based on the following sections of the Act. Table 1 shows the relationship between these sections of the Act and the requirements in this part.
(1)
(2)
(i) Under section 1903(g)(1)(A), a physician must certify at admission, and a physician (or physician assistant or nurse practitioner under the supervision of a physician) must periodically recertify, the individual's need for inpatient care.
(ii) Under section 1903(g)(1)(B), services must be furnished under a plan established and periodically evaluated by a physician.
(iii) Under section 1903(g)(1)(C), the State must have in effect a continuous program of review of utilization of care and services under section 1902(a)(30) whereby each admission is reviewed or screened in accordance with criteria established by medical and other professional personnel.
(iv) Under section 1903(g)(1)(D), the State must have an effective program under sections 1902(a) (26) and (31) of review of care in intermediate care facilities and mental hospitals. This must include evaluation at least annually of the professional management of each case.
(3)
(4)
(5)
(6)
(7)
(8)
(a) A State plan must provide that the requirements of this part are met.
(b) These requirements may be met by the agency by:
(1) Assuming direct responsibility for assuring that the requirements of this part are met; or
(2) Deeming of medical and utilization review requirements if the agency contracts with a QIO to perform that review, which in the case of inpatient acute care review will also serve as the initial determination for QIO medical necessity and appropriateness review for patients who are dually entitled to benefits under Medicare and Medicaid.
(c) In accordance with § 431.15 of this subchapter, FFP will be available for expenses incurred in meeting the requirements of this part.
The Medicaid agency must implement a statewide surveillance and utilization control program that—
(a) Safeguards against unnecessary or inappropriate use of Medicaid services and against excess payments;
(b) Assesses the quality of those services;
(c) Provides for the control of the utilization of all services provided under the plan in accordance with subpart B of this part; and
(d) Provides for the control of the utilization of inpatient services in accordance with subparts C through I of this part.
(a) The agency must—
(1) Monitor the statewide utilization control program;
(2) Take all necessary corrective action to ensure the effectiveness of the program;
(3) Establish methods and procedures to implement this section;
(4) Keep copies of these methods and procedures on file; and
(5) Give copies of these methods and procedures to all staff involved in carrying out the utilization control program.
The agency must establish and use written criteria for evaluating the appropriateness and quality of Medicaid services. This section does not apply to services in hospitals and mental hospitals. For these facilities, see the following sections: §§ 456.122 and 456.132 of subpart C; and § 456.232 of subpart D.
(a) The Medicaid agency must have an agreement with the State health agency or other appropriate State medical agency, under which the health or medical agency is responsible for establishing a plan for the review by professional health personnel of the appropriateness and quality of Medicaid services.
(b) The purpose of this review plan is to provide guidance to the Medicaid agency in the administration of the State plan and, where applicable, to the State licensing agency described in § 431.610.
This subpart prescribes utilization control requirements applicable to all services provided under a State plan.
To promote the most effective and appropriate use of available services and facilities the Medicaid agency must have procedures for the on-going evaluation, on a sample basis, of the need for and the quality and timeliness of Medicaid services.
The agency must have a post-payment review process that—
(a) Allows State personnel to develop and review—
(1) Recipient utilization profiles;
(2) Provider service profiles; and
(3) Exceptions criteria; and
(b) Identifies exceptions so that the agency can correct misutilization practices of recipients and providers.
This subpart prescribes requirements for control of utilization of inpatient hospital services, including requirements concerning—
(a) Certification of need for care;
(b) Plan of care; and
(c) Utilization review plans.
As used in this subpart:
(a) Include—
(1) Services provided in an institution other than an institution for mental disease, as defined in § 440.10;
(2) [Reserved]
(3) Services provided in specialty hospitals and
(b) Exclude services provided in mental hospitals. Utilization control requirements for mental hospitals appear in subpart D.
(a)
(2) The certification must be made at the time of admission or, if an individual applies for assistance while in a hospital, before the Medicaid agency authorizes payment.
(b)
(2) Recertifications must be made at least every 60 days after certification.
(a) Before admission to a hospital or before authorization for payment, a physician and other personnel involved in the care of the individual must establish a written plan of care for each applicant or recipient.
(b) The plan of care must include—
(1) Diagnoses, symptoms, complaints, and complications indicating the need for admission;
(2) A description of the functional level of the individual;
(3) Any orders for—
(i) Medications;
(ii) Treatments;
(iii) Restorative and rehabilitative services;
(iv) Activities;
(v) Social services;
(vi) Diet;
(4) Plans for continuing care, as appropriate; and
(5) Plans for discharge, as appropriate.
(c) Orders and activities must be developed in accordance with physician's instructions.
(d) Orders and activities must be reviewed and revised as appropriate by all personnel involved in the care of an individual.
(e) A physician and other personnel involved in the recipient's case must review each plan of care at least every 60 days.
Sections 456.101 through 456.145 of this subpart prescribe requirements for a written utilization review (UR) plan for each hospital providing Medicaid services. Sections 456.105 and 456.106
(a) A State plan must provide that each hospital furnishing inpatient services under the plan has in effect a written UR plan that provides for review of each recipient's need for the services that the hospital furnishes him.
(b) Each written hospital UR plan must meet the requirements under §§ 456.101 through 456.145.
The UR plan must—
(a) Provide for a committee to perform UR required under this subpart;
(b) Describe the organization, composition, and functions of this committee; and
(c) Specify the frequency of meetings of the committee.
(a) For the purpose of this subpart, “UR committee” includes any group organized under paragraphs (b) and (c) of this section.
(b) The UR committee must be composed of two or more physicians, and assisted by other professional personnel.
(c) The UR committee must be constituted as—
(1) A committee of the hospital staff;
(2) A group outside the hospital staff, established by the local medical or osteopathic society and at least some of the hospitals and SNFs in the locality;
(3) A group capable of performing utilization review, established and organized in a manner approved by the Secretary.
(d) The UR committee may not include any individual who—
(1) Is directly responsible for the care of the patient whose care is being reviewed; or
(2) Has a financial interest in any hospital.
The UR plan must provide that each recipient's record includes information needed for the UR committee to perform UR required under this subpart. This information must include, at least, the following:
(a) Identification of the recipient.
(b) The name of the recipient's physician.
(c) Date of admission, and dates of application for and authorization of Medicaid benefits if application is made after admission.
(d) The plan of care required under § 456.70.
(e) Initial and subsequent continued stay review dates described under §§ 456.128 and 456.133.
(f) Date of operating room reservation, if applicable.
(g) Justification of emergency admission, if applicable.
(h) Reasons and plan for continued stay, if the attending physician believes continued stay is necessary.
(i) Other supporting material that the committee believes appropriate to be included in the record.
The UR plan must describe—
(a) The types of records that are kept by the committee; and
(b) The type and frequency of committee reports and arrangements for their distribution to appropriate individuals.
The UR plan must provide that the identities of individual recipients in all UR records and reports are kept confidential.
The UR plan must provide for a review of each recipient's admission to the hospital to decide whether it is needed, in accordance with the requirements of §§ 456.122 through 456.129.
The UR plan must provide that—
(a) The committee develops written medical care criteria to assess the need for admission; and
(b) The committee develops more extensive written criteria for cases that its experience shows are—
(1) Associated with high costs;
(2) Associated with the frequent furnishing of excessive services; or
(3) Attended by physicians whose patterns of care are frequently found to be questionable.
The UR plan must provide that—
(a) Admission review is conducted by—
(1) The UR committee;
(2) A subgroup of the UR committee; or
(3) A designee of the UR committee;
(b) The committee, subgroup, or designee evaluates the admission against the criteria developed under § 456.122 and applies close professional scrutiny to cases selected under § 456.129(b);
(c) If the committee, subgroup, or designee finds that the admission is needed, the committee assigns an initial continued stay review date in accordance with § 456.128;
(d) If the committee, subgroup, or designee finds that the admission does not meet the criteria, the committee or a subgroup that includes at least one physician reviews the case to decide the need for admission;
(e) If the committee or subgroup making the review under paragraph (d) of this section finds that the admission is not needed, it notifies the recipient's attending physician and gives him an opportunity to present his views before it makes a final decision on the need for the continued stay;
(f) If the attending physician does not present additional information or clarification of the need for the admission, the decision of the committee or subgroup is final; and
(g) If the attending physician presents additional information or clarification, at least two physician members of the committee review the need for the admission. If they find that the admission is not needed, their decision if final.
The UR plan must provide that written notice of any adverse final decision on the need for admission under § 456.123 (e) through (g) is sent to—
(a) The hospital administrator;
(b) The attending physician;
(c) The Medicaid agency;
(d) The recipient; and
(e) If possible, the next of kin or sponsor.
Except as required under § 456.127, the UR plan must provide that review of each recipient's admission to the hospital is conducted—
(a) Within one working day after admission, for an individual who is receiving Medicaid at that time; or
(b) Within one working day after the hospital is notified of the application for Medicaid, for an individual who applies while in the hospital.
Except as required under § 456.127, the UR plan must provide that the committee makes a final decision on a recipient's need for admission and gives notice of an adverse final decision—
(a) Within two working days after admission, for an individual who is receiving Medicaid at that time; or
(b) Within two working days after the hospital is notified of the application for Medicaid, for an individual who applies while in the hospital.
The UR plan must provide for review and final decision prior to admission for certain providers or categories of admissions that the UR committee designates under § 456.142(b) (4)(iii) to receive pre-admission review.
The UR plan must provide that—
(a) When a recipient is admitted to the hospital under the admission review requirements of this subpart, the committee assigns a specified date by which the need for his continued stay will be reviewed;
(b) The committee bases its assignment of the initial continued stay review date on—
(1) The methods and criteria required to be described under § 456.129;
(2) The individual's condition; and
(3) The individual's projected discharge date;
(c)(1) The committee uses any available appropriate regional medical care appraisal norms, such as those developed by abstracting services or third party payors, to assign the initial continued stay review date;
(2) These regional norms are based on current and statistically valid data on duration of stay in hospitals for patients whose characteristics, such as age and diagnosis, are similar to those of the individual whose case is being reviewed;
(3) If the committee uses norms to assign the initial continued stay review date, the number of days between the individual's admission and the initial continued stay review date is no greater than the number of days reflected in the 50th percentile of the norms. However, the committee may assign a later review date if it documents that the later date is more appropriate; and
(d) The committee ensures that the initial continued stay review date is recorded in the individual's record.
The UR plan must describe—
(a) The methods and criteria, including norms if used, that the committee uses to assign the initial continued stay review date under § 456.128.
(b) The methods that the committee uses to select categories of admission to receive close professional scrutiny under § 456.123(b); and
(c) The methods that the committee uses to modify an approved length of stay when the recipient's condition or treatment schedule changes.
The UR plan must provide for a review of each recipient's continued stay in the hospital to decide whether it is needed, in accordance with the requirements of §§ 456.132 through 456.137.
The UR plan must provide that—
(a) The committee develops written medical care criteria to assess the need for continued stay.
(b) The committee develops more extensive written criteria for cases that its experience shows are—
(1) Associated with high costs;
(2) Associated with the frequent furnishing of excessive services; or
(3) Attended by physicians whose patterns of care are frequently found to be questionable.
The UR plan must provide that—
(a) The committee assigns subsequent continued stay review dates in accordance with §§ 456.128 and 456.134(a);
(b) The committee assigns a subsequent review date each time it decides under § 456.135 that the continued stay is needed; and
(c) The committee ensures that each continued stay review date it assigns is recorded in the recipient's record.
The UR plan must describe—
(a) The methods and criteria, including norms if used, that the committee uses to assign subsequent continued stay review dates under § 456.133; and
(b) The methods that the committee uses to modify an approved length of stay when the recipient's condition or treatment schedule changes.
The UR plan must provide that—
(a) Review of continued stay cases is conducted by—
(1) The UR committee;
(2) A subgroup of the UR committee; or
(3) A designee of the UR committee;
(b) The committee, subgroup or designee reviews a recipient's continued stay on or before the expiration of each assigned continued stay review date;
(c) For each continued stay of a recipient in the hospital, the committee, subgroup or designee reviews and evaluates the documentation described under § 456.111 against the criteria developed under § 456.132 and applies close professional scrutiny to cases selected under § 456.129(b);
(d) If the committee, subgroup, or designee finds that a recipient's continued stay in the hospital is needed, the committee assigns a new continued stay review date in accordance with § 456.133;
(e) If the committee, subgroup, or designee finds that a continued stay case does not meet the criteria, the committee or a subgroup that includes at least one physician reviews the case to decide the need for continued stay;
(f) If the committee or subgroup making the review under paragraph (e) of this section finds that a continued stay is not needed, it notifies the recipient's attending physician and gives him an opportunity to present his reviews before it makes a final decision on the need for the continued stay;
(g) If the attending physician does not present additional information or clarification of the need for the continued stay, the decision of the committee or subgroup is final; and
(h) If the attending physician presents additional information or clarification, at least two physician members of the committee review the need for the continued stay. If they find that the recipient no longer needs inpatient hospital services, their decision is final.
The UR plan must provide that written notice of any adverse final decision on the need for continued stay under § 456.135 (f) through (h) is sent to—
(a) The hospital administrator;
(b) The attending physician;
(c) The Medicaid agency;
(d) The recipient; and
(e) If possible, the next of kin or sponsor.
The UR plan must provide that—
(a) The committee makes a final decision on a recipient's need for continued stay and gives notice under § 456.136 of an adverse final decision within 2 working days after the assigned continued stay review dates, except as required under paragraph (b) of this section.
(b) If the committee makes an adverse final decision on a recipient's need for continued stay before the assigned review date, the committee gives notice under § 456.136 within 2 working days after the date of the final decision.
(a) The purpose of medical care evaluation studies is to promote the most effective and efficient use of available health facilities and services consistent with patient needs and professionally recognized standards of health care.
(b) Medical care evaluation studies—
(1) Emphasize identification and analysis of patterns of patient care; and
(2) Suggest appropriate changes needed to maintain consistently high quality patient care and effective and efficient use of services.
(a) The UR plan must describe the methods that the committee uses to select and conduct medical care evaluation studies under paragraph (b)(1) of this section.
(b) The UR plan must provide that the UR committee—
(1) Determines the methods to be used in selecting and conducting medical care evaluation studies in the hospital;
(2) Documents for each study—
(i) Its results; and
(ii) How the results have been used to make changes to improve the quality of care and promote more effective and efficient use of facilities and services;
(3) Analyzes its findings for each study; and
(4) Takes action as needed to—
(i) Correct or investigate further any deficiencies or problems in the review process for admissions or continued stay cases;
(ii) Recommend more effective and efficient hospital care procedures; or
(iii) Designate certain providers or categories of admissions for review prior to admission.
Each medical care evaluation study must—
(a) Identify and analyze medical or administrative factors related to the hospital's patient care;
(b) Include analysis of at least the following:
(1) Admissions;
(2) Durations of stay;
(3) Ancillary services furnished, including drugs and biologicals;
(4) Professional services performed in the hospital; and
(c) If indicated, contain recommendations for changes beneficial to patients, staff, the hospital, and the community.
Data that the committee uses to perform studies must be obtained from one or more of the following sources:
(a) Medical records or other appropriate hospital data;
(b) External organizations that compile statistics, design profiles, and produce other comparative data;
(c) Cooperative endeavors with—
(1) QIOs;
(2) Fiscal agents;
(3) Other service providers; or
(4) Other appropriate agencies.
The hospital must, at least, have one study in progress at any time and complete one study each calendar year.
This subpart prescribes requirements for control of utilization of inpatient services in mental hospitals, including requirements concerning—
(a) Certification of need for care;
(b) Medical evaluation and admission review;
(c) Plan of care; and
(d) Utilization review plans.
As used in this subpart:
(a)
(2) The certification must be made at the time of admission or, if an individual applies for assistance while in a mental hospital, before the Medicaid agency authorizes payment.
(b)
(2) Recertification must be made at least every 60 days after certification.
(a) Before admission to a mental hospital or before authorization for payment, the attending physician or staff physician must make a medical evaluation of each applicant's or recipient's need for care in the hospital; and appropriate professional personnel must make a psychiatric and social evaluation.
(b) Each medical evaluation must include—
(1) Diagnoses;
(2) Summary of present medical findings;
(3) Medical history;
(4) Mental and physical functional capacity;
(5) Prognoses; and
(6) A recommendation by a physician concerning—
(i) Admission to the mental hospital; or
(ii) Continued care in the mental hospital for individuals who apply for Medicaid while in the mental hospital.
Medical and other professional personnel of the Medicaid agency or its designees must evaluate each applicant's or recipient's need for admission by reviewing and assessing the evaluations required by § 456.170.
(a) Before admission to a mental hospital or before authorization for payment, the attending physician or staff physician must establish a written plan of care for each applicant or recipient.
(b) The plan of care must include—
(1) Diagnoses, symptoms, complaints, and complications indicating the need for admission;
(2) A description of the functional level of the individual;
(3) Objectives;
(4) Any orders for—
(i) Medications;
(ii) Treatments;
(iii) Restorative and rehabilitative services;
(iv) Activities;
(v) Therapies;
(vi) Social services;
(vii) Diet; and
(viii) Special procedures recommended for the health and safety of the patient;
(5) Plans for continuing care, including review and modification to the plan of care; and
(6) Plans for discharge.
(c) The attending or staff physician and other personnel involved in the recipient's care must review each plan of care at least every 90 days.
A written report of each evaluation and plan of care must be entered in the applicant's or recipient's record—
(a) At the time of admission; or
(b) If the individual is already in the facility, immediately upon completion of the evaluation or plan.
Sections 456.201 through 456.245 of this subpart prescribe requirements for a written utilization review (UR) plan for each mental hospital providing Medicaid services. Sections 456.205 and 456.206 prescribe administrative requirements; §§ 456.211 through 456.213 prescribe informational requirements;
(a) The State plan must provide that each mental hospital furnishing inpatient services under the plan has in effect a written UR plan that provides for review of each recipient's need for the services that the mental hospital furnishes him.
(b) Each written mental hospital UR plan must meet the requirements under §§ 456.201 through 456.245.
The UR plan must—
(a) Provide for a committee to perform UR required under this subpart;
(b) Describe the organization, composition, and functions of this committee; and
(c) Specify the frequency of meetings of the committee.
(a) For the purpose of this subpart, “UR committee” includes any group organized under paragraphs (b) and (c) of this section.
(b) The UR committee must be composed of two or more physicians, one of whom is knowledgeable in the diagnosis and treatment of mental diseases, and assisted by other professional personnel.
(c) The UR committee must be constituted as—
(1) A committee of the mental hospital staff;
(2) A group outside the mental hospital staff, established by the local medical or osteopathic society and at least some of the hospitals and SNFs in the locality; or
(3) A group capable of performing utilization review, established and organized in a manner approved by the Secretary.
(d) The UR committee may not include any individual who—
(1) Is directly responsible for the care of patients whose care is being reviewed; or
(2) Has a financial interest in any mental hospital.
The UR plan must provide that each recipient's record includes information needed to perform UR required under this subpart. This information must include, at least, the following:
(a) Identification of the recipient.
(b) The name of the recipient's physician.
(c) Date of admission, and dates of application for and authorization of Medicaid benefits if application is made after admission.
(d) The plan of care required under § 456.172.
(e) Initial and subsequent continued stay review dates described under §§ 456.233 and 456.234.
(f) Reasons and plan for continued stay, if the attending physician believes continued stay is necessary.
(g) Other supporting material that the committee believes appropriate to be included in the record.
The UR plan must describe—
(a) The types of records that are kept by the committee; and
(b) The type and frequency of committee reports and arrangements for their distribution to appropriate individuals.
The UR plan must provide that the identities of individual recipients in all UR records and reports are kept confidential.
The UR plan must provide for a review of each recipient's continued stay
The UR plan must provide that—
(a) The committee develops written medical care criteria to assess the need for continued stay.
(b) The committee develops more extensive written criteria for cases that its experience shows are—
(1) Associated with high costs;
(2) Associated with the frequent furnishing of excessive services; or
(3) Attended by physicians whose patterns of care are frequently found to be questionable.
The UR plan must provide that—
(a) When a recipient is admitted to the mental hospital under admission review requirements of this subpart, the committee assigns a specified date by which the need for his continued stay will be reviewed;
(b) If an individual applies for Medicaid while in the mental hospital, the committee assigns the initial continued stay review date within 1 working day after the mental hospital is notified of the application for Medicaid;
(c) The committee bases its assignment of the initial continued stay review date on—
(1) The methods and criteria required to be described under § 456.235(a);
(2) The individual's condition; and
(3) The individual's projected discharge date;
(d)(1) The committee uses any available appropriate regional medical care appraisal norms, such as those developed by abstracting services or third party payors, to assign the initial continued stay review date;
(2) These norms are based on current and statistically valid data on duration of stay in mental hospitals for patients whose characteristics, such as age and diagnosis, are similar to those of the individual whose need for continued stay is being reviewed;
(3) If the committee uses norms to assign the initial continued stay review date, the number of days between the individual's admission and the initial continued stay review date is no greater than the number of days reflected in the 50th percentile of the norms. However, the committee may assign a later review date if it documents that the later date is more appropriate;
(e) The initial continued stay review date is not in any case later than 30 days after admission of the individual or notice to the mental hospital of his application for Medicaid; and
(f) The committee insures that the initial continued stay review date is recorded in the individual's record.
The UR plan must provide that—
(a) The committee assigns subsequent continued stay review dates in accordance with §§ 456.235(a) and 456.233;
(b) The committee assigns a subsequent continued stay review date at least every 90 days each time it decides under § 456.236 that the continued stay is needed; and
(c) The committee insures that each continued stay review date it assigns is recorded in the recipient's record.
The UR plan must describe—
(a) The methods and criteria, including norms if used, that the committee uses to assign initial and subsequent continued stay review dates under §§ 456.233 and 456.234 of this subpart; and
(b) The methods that the committee uses to modify an approved length of stay when the recipient's condition or treatment schedule changes.
The UR plan must provide that—
(a) Review of continued stay cases is conducted by—
(1) The UR committee;
(2) A subgroup of the UR committee; or
(3) A designee of the UR committee;
(b) The committee, subgroup or designee reviews a recipient's continued
(c) For each continued stay of a recipient in the mental hospital, the committee, subgroup or designee reviews and evaluates the documentation described under § 456.211 against the criteria developed under § 456.232 and applies close professional scrutiny to cases described under § 456.232(b).
(d) If the committee, subgroup or designee finds that a recipient's continued stay in the mental hospital is needed, the committee assigns a new continued stay review date in accordance with § 456.234;
(e) If the committee, subgroup or designee finds that a continued stay case does not meet the criteria, the committee or a subgroup that includes at least one physician reviews the case to decide the need for continued stay;
(f) If the committee or subgroup making the review under paragraph (e) of this section finds that a continued stay is not needed, it notifies the recipient's attending or staff physician and gives him an opportunity to present his views before it makes a final decision on the need for the continued stay;
(g) If the attending or staff physician does not present additional information or clarification of the need for the continued stay, the decision of the committee or subgroup is final; and
(h) If the attending or staff physician presents additional information or clarification, at least two physician members of the committee, one of whom is knowledgeable in the treatment of mental diseases, review the need for the continued stay. If they find that the recipient no longer needs inpatient mental hospital services, their decision is final.
The UR plan must provide that written notice of any adverse final decision on the need for continued stay under § 456.236 (f) through (h) is sent to—
(a) The hospital administrator;
(b) The attending or staff physician;
(c) The Medicaid agency;
(d) The recipient; and
(e) If possible, the next of kin or sponsor.
The UR plan must provide that—
(a) The committee makes a final decision on a recipient's need for continued stay and gives notice under § 456.237 of an adverse decision within 2 working days after the assigned continued stay review date, except as required under paragraph (b) of this section.
(b) If the committee makes an adverse final decision on a recipient's need for continued stay before the assigned review date, the committee gives notice under § 456.237 within 2 working days after the date of the final decision.
(a) The purpose of medical care evaluation studies is to promote the most effective and efficient use of available health facilities and services consistent with patient needs and professionally recognized standards of health care.
(b) Medical care evaluation studies—
(1) Emphasize identification and analysis of patterns of patient care; and
(2) Suggest appropriate changes needed to maintain consistently high quality patient care and effective and efficient use of services.
(a) The UR plan must describe the methods that the committee uses to select and conduct medical care evaluation studies under paragraph (b)(1) of this section.
(b) The UR plan must provide that the UR committee—
(1) Determines the methods to be used in selecting and conducting medical care evaluation studies in the mental hospital;
(2) Documents for each study—
(i) Its results; and
(ii) How the results have been used to make changes to improve the quality of care and promote more effective and efficient use of facilities and services;
(3) Analyzes its findings for each study; and
(4) Takes action as needed to—
(i) Correct or investigate further any deficiencies or problems in the review process; or
(ii) Recommend more effective and efficient hospital care procedures.
Each medical care evaluation study must—
(a) Identify and analyze medical or administrative factors related to the mental hospital's patient care;
(b) Include analysis of at least the following:
(1) Admissions.
(2) Durations of stay.
(3) Ancillary services furnished, including drugs and biologicals.
(4) Professional services performed in the hospital; and
(c) If indicated, contain recommendations for change beneficial to patients, staff, the hospital, and the community.
Data that the committee uses to perform studies must be obtained from one or more of the following sources:
(a) Medical records or other appropriate hospital data.
(b) External organizations that compile statistics, design profiles, and produce other comparative data.
(c) Cooperative endeavors with—
(1) QIOs;
(2) Fiscal agents;
(3) Other service providers; or
(4) Other appropriate agencies.
The mental hospital must, at least, have one study in progress at any time and complete one study each calendar year.
This subpart prescribes requirements for control of utilization of intermediate care facility (ICF) services including requirements concerning—
(a) Certification of need for care;
(b) Medical evaluation and admission review;
(c) Plan of care; and
(d) Utilization review plans.
As used in this subpart:
(a)
(2) The certification must be made at the time of admission or, if an individual applies for assistance while in an ICF, before the Medicaid agency authorizes payment.
(b)
(2) Recertification must be made at least—
(i) Every 12 months after certification in an institution for the mentally retarded or persons with related conditions; and
(ii) Every 60 days after certification in an ICF other than an institution for
(a) Before admission to an ICF or before authorization for payment, an interdisciplinary team of health professionals must make a comprehensive medical and social evaluation and, where appropriate, a psychological evaluation of each applicant's or recipient's need for care in the ICF.
(b) In an institution for the mentally retarded or persons with related conditions, the team must also make a psychological evaluation of need for care. The psychological evaluation must be made before admission or authorization of payment, but not more than three months before admission.
(c) Each evaluation must include—
(1) Diagnoses;
(2) Summary of present medical, social, and where appropriate, developmental findings;
(3) Medical and social family history;
(4) Mental and physical functional capacity;
(5) Prognoses;
(6) Kinds of services needed;
(7) Evaluation by an agency worker of the resources available in the home, family and community; and
(8) A recommendation concerning—
(i) Admission to the ICF; or
(ii) Continued care in the ICF for individuals who apply for Medicaid while in the ICF.
If the comprehensive evaluation recommends ICF services for an applicant or recipient whose needs could be met by alternative services that are currently unavailable, the facility must enter this fact in the recipient's record and begin to look for alternative services.
Medical and other professional personnel of the Medicaid agency or its designees must evaluate each applicant's or recipient's need for admission by reviewing and assessing the evaluations required by § 456.370.
(a) Before admission to an ICF or before authorization for payment, a physician must establish a written plan of care for each applicant or recipient.
(b) The plan of care must include—
(1) Diagnoses, symptoms, complaints, and complications indicating the need for admission;
(2) A description of the functional level of the individual;
(3) Objectives;
(4) Any orders for—
(i) Medications;
(ii) Treatments;
(iii) Restorative and rehabilitative services;
(iv) Activities;
(v) Therapies;
(vi) Social services;
(vii) Diet; and
(viii) Special procedures designed to meet the objectives of the plan of care;
(5) Plans for continuing care, including review and modification of the plan of care; and
(6) Plans for discharge.
(c) The team must review each plan of care at least every 90 days.
A written report of each evaluation and plan of care must be entered in the applicant's or recipient's record—
(a) At the time of admission; or
(b) If the individual is already in the ICF, immediately upon completion of the evaluation or plan.
Sections 456.401 through 456.438 of this subpart prescribe requirements for a written utilization review (UR) plan
(a) The State plan must provide that—
(1) UR is performed for each ICF that furnishes inpatient services under the plan;
(2) Each ICF has on file a written UR plan that provides for review of each recipient's need for the services that the ICF furnishes him; and
(3) Each written ICF UR plan meets requirements under §§ 456.401 through 456.438.
(b) The State plan must specify the method used to perform UR, which may be—
(1) Review conducted by the facility;
(2) Direct review in the facility by individuals—
(i) Employed by the medical assistance unit of the Medicaid agency; or
(ii) Under contract to the Medicaid agency; or
(3) Any other method.
The UR plan must include a written description of—
(a) How UR is performed in the ICF; and
(b) When UR is performed.
(a) The UR plan must include a written description of who performs UR in the ICF.
(b) UR must be performed using a method specified under § 456.401(b) by a group of professional personnel that includes—
(1) At least one physician;
(2) In an ICF that cares primarily for mental patients, at least one individual knowledgeable in the treatment of mental diseases; and
(3) In an institution for the mentally retarded, a least one individual knowledgeable in the treatment of mental retardation.
(c) The group performing UR may not include any individual who—
(1) Is directly responsible for the care of the recipient whose care is being reviewed;
(2) Is employed by the ICF; or
(3) Has a financial interest in any ICF.
The UR plan must describe—
(a) The UR support responsibilities of the ICF's administrative staff; and
(b) Procedures used by the staff for taking needed corrective action.
The UR plan must provide that each recipient's record include information needed to perform UR required under this subpart. This information must include, at least, the following:
(a) Identification of the recipient.
(b) The name of the recipient's physician.
(c) The name of the qualified mental retardation professional (as defined under § 442.401 of this subchapter), if applicable.
(d) Date of admission, and dates of application for and authorization of Medicaid benefits if application is made after admission.
(e) The plan of care required under § 456.372;
(f) Initial and subsequent continued stay review dates described under §§ 456.433 and 456.434.
(g) Reasons and plan for continued stay, if the attending physician or qualified mental retardation professional believes continued stay is necessary.
(h) Other supporting material that the UR group believes appropriate to be included in the record.
The UR plan must describe—
(a) The types of records that are kept by the group performing UR; and
(b) The type and frequency of reports made by the UR group, and arrangements for distribution of the reports to appropriate individuals.
The UR plan must provide that the identities of individual recipients in all UR records and reports are kept confidential.
(a) The UR plan must provide for a review of each recipients continued stay in the ICF at least every 6 months to decide whether it is needed.
(b) The UR plan requirement for continued stay review may be met by—
(1) Reviews that are performed in accordance with the requirements of §§ 456.432 through 456.437; or
(2) Reviews that meet on-site inspection requirements under subpart I if—
(i) The composition of the independent professional review team under subpart I meets the requirements of § 456.406; and
(ii) Reviews are conducted as frequently as required under §§ 456.433 and 456.434.
The UR plan must provide that—
(a) The group performing UR develops written criteria to assess the need for continued stay.
(b) The group develops more extensive written criteria for cases that its experience shows are—
(1) Associated with high costs;
(2) Associated with the frequent furnishing of excessive services; or
(3) Attended by physicians whose patterns of care are frequently found to be questionable.
The UR plan must provide that—
(a) When a recipient is admitted to the ICF under admission review requirements of this subpart, the group performing UR assigns a specified date by which the need for his continued stay will be reviewed;
(b) The group performing UR bases its assignment of the initial continued stay review date on the methods and criteria required to be described under § 456.435(a);
(c) The initial continued stay review date is—
(1) Not later than 6 months after admission; or
(2) Earlier than 6 months after admission, if indicated at the time of admission; and
(d) The group performing UR insures that the initial continued stay review date is recorded in the recipient's record.
The UR plan must provide that—
(a) The group performing UR assigns subsequent continued stay review dates in accordance with § 456.435.
(b) The group assigns a subsequent continued stay review date each time it decides under § 456.436 that the continued stay is needed—
(1) At least every 6 months; or
(2) More frequently than every six months if indicated at the time of continued stay review; and
(c) The group insures that each continued stay review date it assigns is recorded in the recipient's record.
The UR plan must describe the methods and criteria that the group performing UR uses to assign initial and subsequent continued stay review dates under §§ 456.433 and 456.434.
The UR plan must provide that—
(a) Review of continued stay cases is conducted by—
(1) The group performing UR; or
(2) A designee of the UR group;
(b) The group or its designee reviews a recipient's continued stay on or before the expiration of each assigned continued stay review date.
(c) For each continued stay of a recipient in the ICF, the group or its designee reviews and evaluates the documentation described under § 456.411 against the criteria developed under § 456.432 and applies close professional scrutiny to cases described under § 456.432(b);
(d) If the group or its designee finds that a recipient's continued stay in the ICF is needed, the group assigns a new continued stay review date in accordance with § 456.434;
(e) If the group or its designee finds that a continued stay case does not meet the criteria, the group or a subgroup that includes at least one physician reviews the case to decide the need for continued stay;
(f) If the group or subgroup making the review under paragraph (e) of this section finds that a continued stay is not needed, it notifies the recipient's attending physician or, in institutions for the mentally retarded, the recipient's qualified mental retardation professional, within 1 working day of its decision, and gives him 2 working days from the notification date to present his views before it makes a final decision on the need for the continued stay;
(g) If the attending physician or qualified mental retardation professional does not present additional information or clarification of the need for the continued stay, the decision of the UR group is final;
(h) If the attending physician or qualified mental retardation professional presents additional information or clarification, the need for continued stay is reviewed by—
(1) The physician member(s) of the UR group, in cases involving a medical determination; or
(2) The UR group, in cases not involving a medical determination; and
(i) If the individuals performing the review under paragraph (h) of this section find that the recipient no longer needs ICF services, their decision is final.
The UR plan must provide that written notice of any adverse final decision on the need for continued stay under § 456.436 (g) through (i) is sent to—
(a) The ICF administrator;
(b) The attending physician;
(c) The qualified mental retardation professional, if applicable;
(d) The Medicaid agency;
(e) The recipient; and
(f) If possible, the next of kin or sponsor.
The UR plan must provide that the group gives notice under § 456.437 of an adverse decision not later than 2 days after the date of the final decision.
This subpart concerns admission and plan of care requirements that apply to inpatient psychiatric services for individuals under age 21 in hospitals, mental hospitals, and intermediate care facilities.
If a facility provides inpatient psychiatric services to a recipient under age 21—
(a) The admission certification by the review team required in § 441.152 satisfies the requirement for physician certification of need for care in §§ 456.60, 456.160, and 456.360; and
(b) The development and review of the plan of care required in § 441.154 satisfies the requirement for physician recertification of need for care in the sections cited in paragraph (a) and the requirement for establishment and periodic review of the plan of care in §§ 456.80, 456.180, and 456.380.
(c) The plan of care must be established by the team described in § 441.156.
If a facility provides inpatient psychiatric services to a recipient under age 21, the medical, psychiatric, and social evaluations required by §§ 456.170, and 456.370 must be made by the team described in § 441.153.
For hospitals and mental hospitals, this subpart—
(a) Prescribes conditions for the availability of FFP relating to UR plans;
(b) Prescribes conditions for granting a waiver of UR plan requirements; and
(c) Prescribes conditions for granting a variance in UR plan requirements for remote facilities.
(a) Except when waived under §§ 456.505 through 456.508, FFP is not available in expenditures for Medicaid services furnished by a hospital or mental hospital unless the facility has in effect a UR plan that meets the utilization review requirements for Medicare under section 1861(k) of the Act.
(b) A facility that participates in Medicare and Medicaid must use the same UR standards and procedures and review committee for Medicaid as it uses for Medicare.
(c) A facility that does not participate in Medicare must meet the UR plan requirements in subpart C or D of this part, which are equivalent to the Medicare UR plan requirements in §§ 405.1137, 482.30, and 482.60 of this chapter.
The Administrator may waive the UR plan requirements of subparts C or D of this part, except for provisions relating to disqualification of UR committee members under § 456.106 of subpart C, and § 456.206 of subpart D, if the Medicaid agency—
(a) Applies for a waiver; and
(b) Demonstrates to the Administrator's satisfaction that it has in operation specific UR procedures that are superior in their effectiveness to the UR plan requirements under subpart C or D of this part.
(a) The agency may apply for a waiver at any time it has the procedures referred to under § 456.505(b) in operation at least—
(1) On a demonstration basis; or
(2) In any part of the State.
(b) Any hospital or mental hospital participating under the plan that is not covered by a waiver must continue to meet all the UR plan requirements under subpart C or D of this part.
(a) When the agency applies for a waiver, the Administrator will assess the agency's UR procedures and grant the waiver if he determines that the procedures meet criteria he establishes.
(b) The Administrator will review and evaluate each waiver between 1 and 2 years after he has granted it and between 1 and 2 years periodically thereafter.
(a) The Administrator will withdraw a waiver if he determines that State procedures are no longer superior in their effectiveness to the procedures required for UR plans under subpart C or D of this part.
(b) If a waiver is withdrawn by the Administrator, each hospital or mental hospital covered by the waiver must meet all the UR plan requirements under subpart C or D of this part.
As used in §§ 456.521 through 456.525 of this subpart:
(a) Is professionally qualified;
(b) Is not precluded from participating in UR under § 456.107 of subpart C; or § 456.207 of subpart D; and
(c) Is not precluded from effective participation in UR because he requires more than approximately 1 hour to travel between the remote facility and his place of work.
(a) Except as described under paragraph (b) of this section, the administrator may grant a variance for a specific remote facility if the agency submits concurrently—
(1) A request for the variance that documents to his satisfaction that the facility is unable to meet the time requirements for which the variance is requested; and
(2) A revised UR plan for the facility.
(b) The Administrator will not grant a variance if the remote facility is operating under a UR plan waiver that the Secretary has granted or is considering under §§ 456.505 through 456.508.
The agency's request for a variance must include—
(a) The name, location, and type of the remote facility;
(b) The number of total patient admissions and the average daily patient census at the facility in the 6 months preceding the request;
(c) The number of Medicare and Medicaid patient admissions and the average daily Medicare and Medicaid patient census at the facility in the 6 months preceding the request;
(d) The name and location of each hospital, mental hospital, and ICF located within a 50-mile radius of the facility;
(e) The distance and average travel time between the remote facility and each facility listed in paragraph (e) of this section;
(f) Documentation by the facility of its attempts to obtain the services of available physicians or other professional personnel, or both;
(g) The names of all physicians on the active staff, and the names of all other professional personnel on the staff whose availability is relevant to the request;
(h) The practice locations of available physicians and the estimated number of available professional personnel whose availability is relevant to the request;
(i) Documentation by the facility of its inability to perform UR within the time requirements for which the variance is requested and its good faith efforts to comply with the UR plan requirements of subpart C or D of this part;
(j) An assurance by the facility that it will continue its good faith efforts to meet the UR plan requirements of subpart C or D of this part; and
(k) A statement of whether a planning or conditional PSRO exists in the area where the facility is located.
(a) The revised UR plan for the remote facility must specify the methods and procedures that the facility will use if a variance is granted to insure that it—
(1) Maintains effective and timely control over the utilization of services; and
(2) Conducts reviews in a way that improves the quality of care provided to patients.
(b) The revised UR plan for the remote facility is the basis for validation of UR under sec. 1903(g)(2) of the Act for the period when a variance is in effect.
(a) The Administrator—
(1) Will notify the agency of the action he takes on its request for a variance; and
(2) Will specify the period of time, not to exceed 1 year, for which the variance may be granted.
(b) When it receives the Administrator's notification, the agency must promptly notify the remote facility of his action.
(a) The agency must submit a request for renewal of a variance to the Administrator at least 30 days before the variance expires.
(b) The renewal request must contain the information required under § 456.522.
(c) The renewal request must show, to the Administrator's satisfaction, that the remote facility continues to meet the requirements of §§ 456.521 through 456.523.
This subpart prescribes requirements for periodic inspections of care and services intermediate care facilities (ICF's), and institutions for mental diseases (IMD's).
For purposes of this subpart—
(a) A team, as described in this section and § 456.603 must periodically inspect the care and services provided to recipients in each facility.
(b) Each team conducting periodic inspections must have a least one member who is at physician or registered nurse and other appropriate health and social service personnel.
(c) For an IMD other than an ICF, each team must have a psychiatrist or physician knowledgeable about mental institutions and other appropriate mental health and social service personnel.
(d) For an ICF that primarily cares for mental patients, each team must have at least one member who knows
(e) For an institution for the mentally retarded or persons with related conditions, each team must have at least one member who knows the problems and needs of mentally retarded individuals.
(f) For ICFs primarily serving individuals 65 years of age or older, each team must have at least one member who knows the problems and needs of those individuals.
(g) If there is no physician on the team, the Medicaid agency must insure that a physician is available to provide consultation to the team.
(h) If a team has one or more physicians, it must be supervised by a physician.
(a) Except as provided in paragraph (b) of this section—
(1) [Reserved]
(2) No member of a team that reviews care in an ICF may have a financial interest in or be employed by any ICF.
(b) A member of a team that reviews care in an IMD or an institution for the mentally retarded or persons with related conditions—
(1) May not have a financial interest in any institution of that same type but may have a financial interest in other facilities or institutions; and
(2) May not review care in an institution where he is employed but may review care in any other facility or institution.
No physician member of a team may inspect the care of a recipient for whom he is the attending physician.
There must be a sufficient number of teams so located within the State that onsite inspections can be made at appropriate intervals in each facility caring for recipients.
The team and the agency must determine, based on the quality of care and services being provided in a facility and the condition of recipients in the facility, at what intervals inspections will be made. However, the team must inspect the care and services provided to each recipient in the facility at least annually.
No facility may be notified of the time of inspection more than 48 hours before the scheduled arrival of the team.
(a) For recipients under age 21 in psychiatric facilities and recipients in ICFs, other than those described in paragraph (b) of this section, the team's inspection must include—
(1) Personal contact with and observation of each recipient; and
(2) Review of each recipient's medical record.
(b) For recipients age 65 or older in IMDs, the team's inspection must include—
(1) Review of each recipient's medical record; and
(2) If the record does not contain complete reports of periodic assessments required by § 441.102 of this subchapter or, if such reports are inadequate, personal contact with and observation of each recipient
The team must determine in its inspection whether—
(a) The services available in the facility are adequate to—
(1) Meet the health needs of each recipient, and the rehabilitative and social needs of each recipient in an ICF; and
(2) Promote his maximum physical, mental, and psychosocial functioning.
(b) It is necessary and desirable for the recipient to remain in the facility;
(c) It is feasible to meet the recipient's health needs and, in an ICF, the recipient's rehabilitative needs, through alternative institutional or noninstitutional services; and
(d) Each recipient under age 21 in a psychiatric facility and each recipient in an institution for the mentally retarded or persons with related conditions is receiving active treatment as defined in § 441.154 of this subchapter.
In making the determinations on adequacy of services and related matters under § 456.609 for each recipient, the team may consider such items as whether—
(a) The medical evaluation, any required social and psychological evaluations, and the plan of care are complete and current; the plan of care and, where required, the plan of rehabilitation are followed; and all ordered services, including dietary orders, are provided and properly recorded;
(b) The attending physician reviews prescribed medications—
(1) At least every 30 days in psychiatric facilities, and mental hospitals; and
(2) At least quarterly in ICFs;
(c) Tests or observations of each recipient indicated by his medication regimen are made at appropriate times and properly recorded;
(d) Physician, nurse, and other professional progress notes are made as required and appear to be consistent with the observed condition of the recipient;
(e) The recipient receives adequate services, based on such observations as—
(1) Cleanliness;
(2) Absence of bedsores;
(3) Absence of signs of malnutrition or dehydration; and
(4) Apparent maintenance of maximum physical, mental, and psychosocial funtion;
(f) In an ICF, the recipient receives adequate rehabilitative services, as evidenced by—
(1) A planned program of activities to prevent regression; and
(2) Progress toward meeting objectives of the plan of care;
(g) The recipient needs any service that is not furnished by the facility or through arrangements with others; and
(h) The recipient needs continued placement in the facility or there is an appropriate plan to transfer the recipient to an alternate method of care.
(a) The team must submit a report promptly to the agency on each inspection.
(b) The report must contain the observations, conclusions, and recommendations of the team concerning—
(1) The adequacy, appropriateness, and quality of all services provided in the facility or through other arrangements, including physician services to recipients; and
(2) Specific findings about individual recipients in the facility.
(c) The report must include the dates of the inspection and the names and qualifications of the members of the team.
The agency must send a copy of each inspection report to—
(a) The facility inspected;
(b) The facility's utilization review committee;
(c) The agency responsible for licensing, certification, or approval of the facility for purposes of Medicare and Medicaid; and
(d) Other State agencies that use the information in the reports to perform their official function, including, if inspection reports concern IMD's, the appropriate State mental health authorities.
The agency must take corrective action as needed based on the report and recommendations of the team submitted under this subpart.
A utilization review committee under subparts C through F of this part may conduct the periodic inspections required by this subpart if—
(a) The committee is not based in the facility being reviewed; and
(b) The composition of the committee meets the requirements of this subpart.
Secs. 1102 and 1903(g) of the Social Security Act (42 U.S.C. 1302 and 1396 b(g)).
(a)
(b)
(1) What States must do to make a satisfactory showing;
(2) How the Administrator will determine whether reductions will be imposed; and
(3) How the required reductions will be implemented.
(c)
(1) Services provided under a contract with a health maintenance organization; or
(2) Facilities in which a QIO is performing medical and utilization reviews under contract with the Medicaid agency in accordance with § 431.630 of this chapter.
For purposes of this subpart—
(a)
(1) Certification and recertification of the need for inpatient care, as specified in §§ 456.60, 456.160, 456.360 and 456.481.
(2) A plan of care established and periodically reviewed and evaluated by a physician, as specified in §§ 456.80, 456.180, and 456.481.
(3) A continuous program of utilization review under which the admission of each recipient is reviewed or screened in accordance with section 1903(g)(1)(C) of the Act; and
(4) A regular program of reviews, including medical evaluations, and annual on-site reviews of the care of each recipient, as specified in §§ 456.170, and 456.482 and subpart I of this part.
(b)
(2) An on-site review is required in a facility by the end of a quarter if the facility entered the Medicaid program during the same calendar quarter 1 year earlier or has not been reviewed since the same calendar quarter 1 year
(3) If a facility is not reviewed in the quarter in which it is required to be reviewed under paragraph (b)(2) of this section, it will continue to require a review in each subsequent quarter until the review is performed.
(4) The requirement for an on-site review in a given quarter is not affected by the addition or deletion of a level of care in a facility's provider agreement.
(c)
The Administrator will find an agency's showing satisfactory, even if it failed to meet the annual review requirements of § 456.652(a)(4), if—
(a) The agency demonstrates that—
(1) It completed reviews by the end of the quarter in at least 98 percent of all facilities requiring review by the end of the quarter;
(2) It completed reviews by the end of the quarter in all facilities with 200 or more certified Medicaid beds requiring review by the end of the quarter; and
(3) With respect to all unreviewed facilities, the agency exercised good faith and due diligence by attempting to review those facilities and would have succeeded but for events beyond its control which it could not have reasonably anticipated; or
(b) The agency demonstrates that it failed to meet the standard in paragraph (a) (1) and (2) of this section by the close of the quarter for technical reasons, but met the standard within 30 days after the close of the quarter. Technical reasons are circumstances within the agency's control.
(c) Facilities that are reviewed under paragraph (b) of this section, after the quarter in which they were due for review, retain their original anniversary quarter due date for purposes of subsequent reviews.
(a) An agency's showing for a quarter must—
(1) Include a certification by the agency that the requirements of § 456.652(a) (1) through (4) were met during the quarter for each level of care or, if applicable, a certification of the reasons the annual on-site review requirements of § 456.652(a)(4) were not met in any facilities;
(2) For all mental hospitals, intermediate care facilities, and facilities providing inpatient psychiatric services for individuals under 21, participating in Medicaid any time during the 12-month period ending on the last day of the quarter, list each facility by level of care, name, address and provider number;
(3) For each facility entering or leaving the program during the 12-month period ending on the last day of the quarter, list the beginning or ending dates of the provider agreement and supply a copy of the provider agreement;
(4) If review has been contracted to a QIO under § 431.630 of this chapter, list the date the QIO contracted for review.
(5) List all dates of on-site reviews completed by review teams anytime during the 12-month period ending on the last day of the quarter;
(6) For all facilities in which an on-site review was required but not conducted, list the facility by name, address and provider number;
(7) For each on-site review in a mental hospital, intermediate care facility that primarily cares for mental patients, or inpatient psychiatric facility, list the name and qualifications of one team member who is a physician; and
(8) For each on-site review in an intermediate care facility that does not primarily care for mental patients, list the name and qualifications of one team member who is either a physician or registered nurse.
(b) The quarterly showing must be in the form prescribed by the Administrator.
(c) The quarterly showing must be postmarked or received within 30 days after the close of the quarter for which it is made, unless the agency demonstrates good cause for later submittal and the showing is postmarked or received within 45 days after the close of the quarter. Good cause means unanticipated circumstances beyond the agency's control.
(a) The Administrator will periodically validate showings submitted under § 456.654. Validation procedures will include on-site sample surveys of institutions and surveys at the Medicaid agencies.
(b) The Administrator will not find an agency's showing satisfactory if the information obtained through his validation procedures demonstrates, that any of the requirements of § 456.652(a) (1) through (4) were not met during the quarter for which the showing was made.
(a) If the Administrator determines an agency's showing does not meet each of the requirements of this sub-part, he will give the agency 30 days notice before making the required reduction.
(b) If the Administrator determines that a showing for any quarter is unsatisfactory on its face, he will make the required reduction in the grant award based on the Quarterly Medicaid Statement of Expenditures for the Medical Assistance Program for that quarter. (This form CMS-64 is described in § 430.30(c) of this chapter.)
(c) If the Administrator finds a showing satisfactory on its face, but after validation determines the showing to be unsatisfactory, he will notify the agency of any required reduction in FFP no later than the first day of the fourth calendar quarter following the calendar quarter for which the showing was made. Any required reduction will be made by amending or adjusting the agency's grant award.
(d) The agency may request reconsideration of a reduction in accordance with the procedures specified in 45 CFR part 16.
(a) For each level of care specified in a provider agreement, and for each quarter for which a satisfactory showing is not made, the amount of the reduction in FFP is computed as follows:
(1) For each level of care, the number of recipients who received services in facilities that did not meet the requirements of this subpart is divided by the total number of recipients who received services in facilities for which a showing was required under this subpart. If any of the requirements specified in § 456.652(a)(1) through (4) were not met for any recipient in a facility, the reduction will be computed on the total number of recipients in that facility at the level of care in question.
(2) The fraction obtained in paragraph (a)(1) of this section is multiplied by one-third.
(3) The product obtained in paragraph (a)(2) of this section is multiplied by the Federal Medical Assistance Percentage (FMAP).
(4) The product obtained in paragraph (a)(3) of this section is multiplied by the agency payments for longstay services furnished during the quarter at that level of care.
(b) If any of the data required to compute the amount of the reduction in FFP are unavailable, the Administrator will substitute an estimate. If the agency determines the exact data to the satisfaction of the Administrator, the estimate may later be adjusted. If the number of recipients in individual facilities is not available, the fraction specified in paragraph (a)(1) of this section will be estimated, for each level of care, by dividing the number of facilities in which the requirements were not met by the total number of facilities for which a showing is required under this subpart.
This subpart prescribes requirements for—
(a) An outpatient DUR program that includes prospective drug review, retrospective drug use review, and an educational program;
(b) The establishment, composition, and functions of a State DUR Board; and
(c) An optional point-of-sale electronic claims management system for processing claims for covered outpatient drugs.
For purposes of this subpart—
(a)
(b)
(c)
(2) The State plan must provide that covered outpatient drugs dispensed by health maintenance organizations are not subject to the requirements of this subpart.
(d)
(e)
(1) Developed directly by the State or its contractor;
(2) Obtained by the State through contracts with commercial vendors of DUR services;
(3) Obtained by the State from independent organizations, such as the United States Pharmacopeial Convention, or entities receiving funding from the Public Health Service, CMS, or State agencies; or
(4) Any combination of paragraphs (e)(1) through (e)(3) of this section.
(f)
(1) The source materials for their development are consistent with peer-reviewed medical literature (that is, scientific, medical, and pharmaceutical publications in which original manuscripts are published only after having been critically reviewed by unbiased independent experts) and the following compendia:
(i) American Hospital Formulary Service Drug Information;
(ii) United States Pharmacopeia-Drug Information;
(iii) American Medical Association Drug Evaluations.
(2) Differences between source materials were resolved by physicians and pharmacists developing consensus solutions. The consensus process means the reliance, by the criteria developers, on the expertise of physicians and pharmacists to evaluate differences in criteria source materials and to come to agreement on how differences should be resolved.
(3) They are non-proprietary and readily available to providers of services. Systems and algorithms using the predetermined standards may remain proprietary.
(4) They are clinically-based and scientifically valid.
(5) The review based on clinical criteria uses predetermined standards to determine the population at risk of a clinically significant adverse medical result and applies standards, appropriate to this population, across providers and patients to determine the provider outliers whose prescribing, dispensing, or consumption practices may not conform to accepted standards of care. Various statistical measures (including mean, range, or other measures at the discretion of the State) may be applied to these data. Standards may be considered in deciding if an in-depth review is needed to determine whether to intervene once the potential therapeutic problems have been identified through the use of clinical criteria.
(6) They have been tested against claims data prior to adoption in order to validate the level of possibly significant therapeutic problems without undue levels of false positives.
(7) The predetermined standards for prospective and retrospective DUR are compatible.
(8) They are subjected to ongoing evaluation and modification either as a result of actions by their developer or as a result of recommendations by the DUR Board.
(g)
(h)
(a)
(b)
(1) Therapeutic duplication, that is, the prescribing and dispensing of two or more drugs from the same therapeutic class such that the combined daily dose puts the recipient at risk of an adverse medical result or incurs additional program costs without additional therapeutic benefit.
(2) Drug-disease contraindication, that is, the potential for, or the occurrence of—
(i) An undesirable alteration of the therapeutic effect of a given drug because of the presence, in the patient for whom it is prescribed, of a disease condition; or
(ii) An adverse effect of the drug on the patient's disease condition.
(3) Adverse drug-drug interaction, that is, the potential for, or occurrence of, a clinically significant adverse medical effect as a result of the recipient using two or more drugs together.
(4) Incorrect drug dosage, that is, the dosage lies outside the daily dosage specified in predetermined standards as necessary to achieve therapeutic benefit. Dosage is the strength multiplied by the quantity dispensed divided by day's supply.
(5) Incorrect duration of drug treatment, that is, the number of days of prescribed therapy exceeds or falls short of the recommendations contained in the predetermined standards.
(6) Drug-allergy interactions, that is, the significant potential for, or the occurrence of, an allergic reaction as a result of drug therapy.
(7) Clinical abuse/misuse, that is, the occurrence of situations referred to in the definitions of abuse, gross overuse, overutilization, and underutilization, as defined in § 456.702, and incorrect dosage and incorrect duration, as defined in paragraphs (b)(4) and (b)(5) of this section, respectively.
(c)
(i) Whether the offer to counsel is required for new prescriptions only, or for both new and refill prescriptions;
(ii) Whether pharmacists must make the offer to counsel or auxiliary personnel are authorized to make the offer;
(iii) Whether only a patient's refusal of the offer to counsel must be documented, or whether documentation of all offers is required;
(iv) Whether documentation of counseling is required; and
(v) Whether counseling is required in situations where the patient's representative is not readily available to receive a counseling offer or the counseling itself.
(2) The standards must meet the following requirements:
(i) They must require pharmacists to offer to counsel (in person, whenever practicable, or through access to a telephone service that is toll-free for long-distance calls) each recipient or recipient's caregiver who presents a prescription. A pharmacist whose primary patient population is accessible through a local measured or toll-free exchange need not be required to offer toll-free service. Mail order pharmacies are required to provide toll-free telephone service for long distance calls.
(ii) They need not require a pharmacist to provide consultation when a Medicaid recipient or the recipient's caregiver refuses that consultation.
(iii) They must specify what documentation by the pharmacy of refusal of the offer of counseling is required.
(3) The standards must specify that the counseling include those matters listed in paragraphs (c)(3)(i) through (c)(3)(viii) of this section that, in the exercise of his or her professional judgement (consistent with State law regarding the provision of such information), the pharmacist considers significant as well as other matters the pharmacist considers significant.
(i) The name and description of the medication;
(ii) The dosage form, dosage, route of administration, and duration of drug therapy;
(iii) Special directions and precautions for preparation, administration, and use by the patient;
(iv) Common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;
(v) Techniques for self-monitoring drug therapy;
(vi) Proper storage;
(vii) Prescription refill information; and
(viii) Action to be taken in the event of a missed dose.
(d)
(1) Name, address, telephone number, date of birth (or age), and gender of the patient;
(2) Individual history, if significant, including disease state or states, known allergies and drug reactions, and a comprehensive list of medications and relevant devices; and
(3) Pharmacist's comments relevant to the individual's drug therapy.
(a)
(b)
(1) Therapeutic appropriateness, that is, drug prescribing and dispensing that is in conformity with the predetermined standards.
(2) Overutilization and underutilization, as defined in § 456.702.
(3) Appropriate use of generic products, that is, use of such products in conformity with State product selection laws.
(4) Therapeutic duplication as described in § 456.705(b)(1).
(5) Drug-disease contraindication as described in § 456.705(b)(2).
(6) Drug-drug interaction as described in § 456.705(b)(3).
(7) Incorrect drug dosage as described in § 456.705(b)(4).
(8) Incorrect duration of drug treatment as described in § 456.705(b)(5).
(9) Clinical abuse or misuse as described in § 456.705(b)(7).
The State plan must provide for ongoing educational outreach programs that, using DUR Board data on common drug therapy problems, educate practitioners on common drug therapy problems with the aim of improving prescribing and dispensing practices. The program may be established directly by the DUR Board or through contracts with accredited health care educational institutions, State medical societies or State pharmacists associations/societies, or other organizations. The program must include the interventions listed in paragraphs (a) through (d) of this section. The DUR Board determines the content of education regarding common therapy problems and the circumstances in which each of the interventions is to be used.
(a) Dissemination of information to physicians and pharmacists in the State concerning the duties and powers of the DUR Board and the basis for the standards required by § 456.705(c) for use in assessing drug use.
(b) Written, oral, or electronic reminders containing patient-specific or drug-specific information (or both) and suggested changes in prescribing or dispensing practices. These reminders must be conveyed in a manner designed to ensure the privacy of patient-related information.
(c) Face-to-face discussions, with follow up discussions when necessary, between health care professionals expert in appropriate drug therapy and selected prescribers and pharmacists who have been targeted for educational intervention on optimal prescribing, dispensing, or pharmacy care practices.
(d) Intensified review or monitoring of selected prescribers or dispensers.
(a)
(b)
(1) A description of the nature and scope of the prospective drug review program.
(2) A description of how pharmacies performing prospective DUR without computers are expected to comply with the statutory requirement for written criteria.
(3) Detailed information on the specific criteria and standards in use. After the first annual report, information regarding only new or changed criteria must be provided and deleted criteria must be identified.
(4) A description of the steps taken by the State to include in the prospective and retrospective DUR program drugs dispensed to residents of a nursing facility that is not in compliance with the drug regimen review procedures set forth in part 483 of this chapter. After the first annual report, only changes must be reported.
(5) A description of the actions taken by the State Medicaid agency and the DUR Board to ensure compliance with the requirements for predetermined standards at § 456.703(f) and with the access to the predetermined standards requirement at § 456.703(g). After the first annual report, only changes must be reported.
(6) A description of the nature and scope of the retrospective DUR program.
(7) A summary of the educational interventions used and an assessment of the effect of these educational interventions on the quality of care.
(8) A description of the steps taken by the State Agency to monitor compliance by pharmacies with the prospective DUR counseling requirements contained in Federal and State laws and regulations. After the first annual report, only changes must be reported.
(9) Clear statements of purpose that delineate the respective goals, objectives, and scopes of responsibility of the DUR and surveillance and utilization (SUR) functions. These statements must clarify the working relationships between DUR and SUR functions and other entities such as the Medicaid Fraud Control Unit and State Board of Pharmacy. The annual report also must include a statement delineating how functional separation will be maintained between the fraud and abuse activities and the educational activities. After the first annual report, only changes must be reported.
(10) An estimate of the cost savings generated as a result of the DUR program. This report must identify costs of DUR and savings to the Medicaid drug program attributable to prospective and retrospective DUR.
(a) The retrospective DUR requirements in this subpart parallel a portion of the surveillance and utilization review (SUR) requirements in subpart A of this part and in part 455 of this chapter.
(b) A State agency may direct DUR staffs to limit review activities to those that focus on what constitutes appropriate and medically necessary care to avoid duplication of activities relating to fraud and abuse under the SUR program.
(a)
(1) Clinically appropriate prescribing of covered outpatient drugs.
(2) Clinically appropriate dispensing and monitoring of covered outpatient drugs.
(3) Drug use review, evaluation, and intervention.
(4) Medical quality assurance.
(b)
(c)
(d)
(1)
(i) Review and make recommendations on predetermined standards submitted to it by the Medicaid agency or the agency's contractor.
(ii) Evaluate the use of the predetermined standards, including assessing the operational effect of the predetermined standards in use, and make recommendations to the Medicaid agency or the agency's contractor concerning modification or elimination of existing predetermined standards or the addition of new ones.
(iii) Recommend guidelines governing written predetermined standards that pharmacies not using approved software must use in conducting prospective DUR.
(2)
(i) Submit predetermined standards to the DUR Board for its review and recommendations before the Medicaid agency applies them to drug claims data.
(ii) If prospective DUR is conducted using an electronic claims management (ECM) system, apply software approved by the Board.
(iii) If prospective DUR is not conducted through an ECM system, as part of general compliance monitoring, ensure that Medicaid participating pharmacies conduct prospective drug review that screens for the potential drug therapy problems listed in section 1927(g)(2)(A) of the Act.
(3)
(i) Review and make recommendations on predetermined standards submitted to it by the Medicaid agency or the agency's contractor.
(ii) Make recommendations to the Medicaid agency or the agency's contractor concerning modification or elimination of existing predetermined standards or the addition of new ones.
(4)
(5)
(i) Identify and develop educational topics if education of practitioners on common drug therapy problems is needed to improve prescribing or dispensing practices.
(ii) Make recommendations as to which mix of the interventions set forth in §§ 456.711 (a) through (d) would most effectively lead to improvement in the quality of drug therapy. The DUR board recommendations must be based upon an in-depth review of the results of the application of predetermined standards against claims data reports, must be appropriate based upon program experience, and must match the educational program with the drug therapy problems identified.
(iii) Periodically re-evaluate and, if necessary, modify the interventions.
(6)
(i) Apply predetermined standards to drug claims data to generate reports that provide the basis for retrospective education and interventions and furnish those reports to the Board.
(ii) Carry out the educational programs and interventions specified by the Board.
(e)
(1) If the requirements for skilled professional medical personnel at § 432.50 of this chapter are met, at the rate of 75 percent.
(2) If the requirements for skilled professional medical personnel at § 432.50 of this chapter are not met, at the rate specified in § 456.719.
FFP is available for sums that the Secretary determines are attributable to the Statewide adoption of a DUR program as described in this subpart, and payment is made under procedures established in part 433 of this chapter as follows:
(a) For funds expended by the State during calendar years 1991 through 1993, at the rate of 75 percent.
(b) For funds expended by the State after December 31, 1993, at the rate of 50 percent.
(a)
(b)
(1) Eligibility verification, including identification of the following:
(i) Third-party payers.
(ii) Recipients in managed care programs.
(iii) Recipients and providers in restricted service programs (for example, lock-in and lock-out).
(iv) Properly enrolled providers.
(2) Claims data capture, including the following:
(i) Transfer of claims information from the pharmacy to the Medicaid agency or the Medicaid agency's contractor.
(ii) Identification of prescriber.
(iii) Minimum data set (as defined in Part 11 of the State Medicaid Manual).
(3) Claims adjudication, including the following:
(i) Performing all edits and audits contained in the State's Medicaid Management Information System (MMIS) applicable to prescription drugs.
(ii) Notifying the pharmacist (or other authorized person, such as the dispensing physician) about the claim status.
(iii) Taking steps up to, but not including, payment of the claim.
(c)
(1) The ECM system must be acquired through applicable competitive procurement process in the State and must be the most cost-effective telecommunications network and automatic data processing services and equipment. The procurement must meet the procurement requirements set forth in 45 CFR part 74, subpart P, and appendix G-O of OMB circular A-102. The request for proposal (RFP) may be substituted for the advance planning and implementation documents otherwise required by part 433 of this chapter, 45 CFR 95.205, and 45 CFR part 307. A cost-benefit analysis must accompany the RFP. If in its advance planning document, a State establishes that a separate procurement is not cost-effective, modification of an existing fiscal agent contract will be acceptable. In this case, procurement of network services and equipment (but not software modifications) must be competitively procured.
(2) States wishing to do prospective DUR as part of their ECM must do the following:
(i) Submit a cost benefit analysis showing the cost-effectiveness of such a system. A State's decisions as to who must participate in the ECM system and who may decline to do so must be included in the cost-benefit analysis.
(ii) Establish a central State-wide electronic repository for capturing, storing, and updating data for all prescriptions dispensed and for providing access to such data by all authorized participants.
(iii) Design the system to assess data for a review of drug therapy before each prescription is filled or delivered to a Medicaid recipient. The type of review conducted must meet the requirements for prospective drug review set forth in § 456.705.
(3) ECM is considered a subsystem and must be fully integrated with the remainder of the State's MMIS. In addition, information about ECM claims must be part of the single comprehensive utilization and management reporting system used by the DUR program.
(a) For funds expended during calendar quarters in fiscal years 1991 and 1992 and attributable to the design, development, and implementation of an on-line, real-time claims management
(b) FFP is available at a matching rate of 75 percent for funds expended for the following:
(1) Telecommunications equipment and other equipment to directly access MMIS files.
(2) Telecommunications equipment (such as modems and point of sale terminals) furnished to providers.
(3) Operational costs including telecommunications network costs, provided that the ECM system includes eligibility verification systems, electronic claims capture, claims adjudication (except for payment), and a claims data process that is integrated into a single comprehensive utilization and information reporting system.
Section 1102 of the Social Security Act (42 U.S.C. 1302).
Title XXI of the Social Security Act, enacted in 1997 by the Balanced Budget Act, authorizes Federal grants to States for provision of child health assistance to uninsured, low-income children. The program is jointly financed by the Federal and State governments and administered by the States. Within broad Federal rules, each State decides eligible groups, types and ranges of services, payment levels for benefit coverage, and administrative and operating procedures.
(a)
(b)
For purposes of this part the following definitions apply:
(1) A member of a Federally recognized Indian tribe, band, or group;
(2) An Eskimo or Aleut or other Alaska Native enrolled by the Secretary of the Interior pursuant to the Alaska Native Claims Settlement Act, 43 U.S.C. 1601 et. seq.; or
(3) A person who is considered by the Secretary of the Interior to be an Indian for any purpose.
(1) Serious jeopardy to the health of the individual or, in the case of a pregnant woman, the health of a woman or her unborn child;
(2) Serious impairment of bodily function; or
(3) Serious dysfunction of any bodily organ or part.
(1) Furnished by any provider qualified to furnish such services; and (2) Needed to evaluate, treat, or stabilize an emergency medical condition.
(a)
(1) Section 2101(b), which requires that the State submit a State plan.
(2) Section 2102(a), which sets forth requirements regarding the contents of the State plan.
(3) Section 2102(b), which relates to eligibility standards and methodologies.
(4) Section 2102(c), which requires that the State plan include a description of the procedures to be used by the State to accomplish outreach and coordination with other health insurance programs.
(5) Section 2106, which specifies the process for submission, approval, and amendment of State plans.
(6) Section 2107(c), which requires that the State plan include a description of the process used to involve the public in the design and implementation of the plan.
(7) Section 2107(d), which requires that the State plan include a description of the budget for the plan.
(8) Section 2107(e), which provides that certain provisions of title XIX and title XI of the Act apply under title XXI in the same manner that they apply under title XIX.
(b)
(c)
(a)
(b)
(c)
(d)
The State plan is a comprehensive written statement, submitted by the State to CMS for approval, that describes the purpose, nature, and scope of the State's SCHIP and gives an assurance that the program is administered in conformity with the specific requirements of title XXI, title XIX (as appropriate), and the regulations in this chapter. The State plan contains all information necessary for CMS to determine whether the plan can be approved to serve as a basis for Federal financial participation (FFP) in the State program.
A State may seek to amend its approved State plan in whole or in part at any time through the submission of an amendment to CMS. When the State plan amendment has a significant impact on the approved budget, the amendment must include an amended budget that describes the State's planned expenditures for a 1-year period. A State must amend its State plan whenever necessary to reflect—
(a) Changes in Federal law, regulations, policy interpretations, or court decisions that affect provisions in the approved State plan;
(b) Changes in State law, organization, policy, or operation of the program that affect the following program elements described in the State plan:
(1) Eligibility standards, enrollment caps, and disenrollment policies as described in § 457.305.
(2) Procedures to prevent substitution of private coverage as described in § 457.805, and in § 457.810 for premium assistance programs.
(3) The type of health benefits coverage offered, consistent with the options described in § 457.410.
(4) Addition or deletion of specific categories of benefits covered under the State plan.
(5) Basic delivery system approach as described in § 457.490.
(6) Cost-sharing as described in § 457.505.
(7) Screen and enroll procedures, and other Medicaid coordination procedures as described in § 457.350.
(8) Review procedures as described in § 457.1120.
(9) Other comparable required program elements.
(c) Changes in the source of the State share of funding, except for changes in the type of non-health care related revenues used to generate general revenue.
(a)
(1) A State plan or plan amendment takes effect on the day specified in the plan or plan amendment, but no earlier than October 1, 1997.
(2) The effective date may be no earlier than the date on which the State begins to incur costs to implement its State plan or plan amendment.
(3) A State plan amendment that takes effect prior to submission of the amendment to CMS may remain in effect only until the end of the State fiscal year in which the State makes it effective, or, if later, the end of the 90-day period following the date on which the State makes it effective, unless the State submits the amendment to CMS for approval before the end of that State fiscal year or that 90-day period.
(b)
(1) The State certifies that it has provided prior public notice of the proposed change in a form and manner provided under applicable State law; and
(2) The public notice was published before the requested effective date of the change.
(c)
(d)
(e)
(f)
(1) The State adopts a new plan by obtaining approval under § 457.60 of an amendment to the State plan;
(2) Withdraws its plan in accordance with § 457.170(b); or
(3) The Secretary finds substantial noncompliance of the plan with the requirements of the statute or regulations.
(a)
(1) A separate child health program;
(2) A Medicaid expansion program; or
(3) A combination program.
(b)
(c)
(1) Meet the requirements of—
(i) Subpart A;
(ii) Subpart B (to the extent that the State claims administrative costs under title XXI);
(iii) Subpart F (with respect to determination of the allotment for purposes of the enhanced matching rate, determination of the enhanced matching rate, and payment of any claims for administrative costs under title XXI only);
(iv) Subpart G; and
(v) Subpart J (if the State claims administrative costs under title XXI and seeks a waiver of limitations on such claims based on a community based health delivery system).
(2) Be consistent with the State's Medicaid State plan, or an approvable amendment to that plan, as required under title XIX.
(d)
(e)
A State plan must include a description of—
(a) The extent to which, and manner in which, children in the State, including targeted low-income children and other classes of children, by income level and other relevant factors, currently have creditable health coverage (as defined in § 457.10) and, if sufficient information is available, whether the creditable health coverage they have is under public health insurance programs or health insurance programs that involve public-private partnerships;
(b) Current State efforts to provide or obtain creditable health coverage for uncovered children, including the steps the State is taking to identify and enroll all uncovered children who are eligible to participate in public health insurance programs and health insurance programs that involve public-private partnerships; and
(c) Procedures the State uses to accomplish coordination of SCHIP with other public and private health insurance programs, sources of health benefits coverage for children, and relevant child health programs, such as title V, that provide health care services for low-income children. Such procedures include those designed to—
(1) Increase the number of children with creditable health coverage;
(2) Assist in the enrollment in SCHIP of children determined ineligible for Medicaid; and
(3) Ensure that only eligible targeted low-income children are covered under SCHIP, such as those procedures required under §§ 457.350 and 457.353, as applicable.
(a)
(b)
(1) Education and awareness campaigns, including targeted mailings and information distribution through various organizations.
(2) Enrollment simplification, such as simplified or joint application forms.
(3) Application assistance, including opportunities to apply for child health assistance under the plan through community-based organizations and in combination with other benefits and services available to children.
(a)
(b)
(1) Types of benefits, and amount, duration and scope of benefits available under the program.
(2) Cost-sharing requirements as described in § 457.525.
(3) Names and locations of current participating providers.
(4) If an enrollment cap is in effect or the State is using a waiting list, a description of the procedures relating to the cap or waiting list, including the process for deciding which children will be given priority for enrollment, how children will be informed of their status on a waiting list and the circumstances under which enrollment will reopen.
(5) Information on physician incentive plans as required by § 457.985.
(6) Review processes available to applicants and enrollees as described in the State plan pursuant to § 457.1120.
A State plan must include a description of the method the State uses to—
(a) Involve the public in both the design and initial implementation of the program;
(b) Ensure ongoing public involvement once the State plan has been implemented; and
(c) Ensure interaction with Indian Tribes and organizations in the State on the development and implementation of the procedures required at § 457.125.
(a)
(b)
The State plan must include an assurance that the State will comply with all applicable civil rights requirements, including title VI of the Civil Rights Act of 1964, title II of the Americans with Disabilities Act of 1990, section 504 of the Rehabilitation Act of 1973, the Age Discrimination Act of 1975, 45 CFR part 80, part 84, and part 91, and 28 CFR part 35.
The State plan must include an assurance that the State will comply, under title XXI, with the following provisions of titles XIX and XI of the Social Security Act:
(a) Section 1902(a)(4)(C) (relating to conflict of interest standards).
(b) Paragraphs (2), (16) and (17) of section 1903(i) (relating to limitations on payment).
(c) Section 1903(w) (relating to limitations on provider donations and taxes).
(d) Section 1132 (relating to periods within which claims must be filed).
The State plan, or plan amendment that has a significant impact on the approved budget, must include a budget that describes the State's planned expenditures for a 1-year period. The budget must describe—
(a) Planned use of funds, including—
(1) Projected amount to be spent on health services;
(2) Projected amount to be spent on administrative costs, such as outreach, child health initiatives, and evaluation; and
(3) Assumptions on which the budget is based, including cost per child and expected enrollment; and
(b) Projected sources of non-Federal plan expenditures, including any requirements for cost sharing by enrollees.
(a)
(b)
(c)
(d)
(e)
(2) CMS notifies the State of the identity of the designated individual in the first correspondence relating to that plan, and at any time there is a change in the designated individual.
(3) In the temporary absence of the designated individual during regular business hours, an alternate individual will act in place of the designated individual.
(a)
(b)
(i) Written notice of disapproval; or
(ii) Written notice of additional information it needs in order to make a final determination.
(2) A State plan or plan amendment is considered received when the designated official or individual, as determined in § 457.150(d) and (e), receives an electronic, fax or paper copy of the complete material.
(3) If CMS requests additional information, the 90-day review period for CMS action on the State plan or plan amendment—
(i) Stops on the day CMS sends a written request for additional information or the next business day if the request is sent on a Federal holiday or weekend; and
(ii) Resumes on the next calendar day after the CMS designated individual receives an electronic, fax, or hard copy from the State of all the requested additional information, unless the information is received after 5 p.m. eastern standard time on a day prior to a non-business day or any time on a non-business day, in which case the review period resumes on the following business day.
(4) The 90-day review period cannot stop or end on a non-business day. If the 90th calendar day falls on a non-business day, CMS will consider the 90th day to be the next business day.
(5) CMS may send written notice of its need for additional information as many times as necessary to obtain the complete information necessary to review the State plan or plan amendment.
(a)
(b)
(a)
(b)
(a)
(1) The program is being operated in a cost-efficient manner; and
(2) Funds are being properly expended for the purposes for which they were appropriated under Federal and State law and regulations.
(b)
(2) The reports set forth OIG opinion and recommendations regarding the practices it reviewed, and the allowability of the costs it audited.
(3) Cognizant officials of the Department make final determinations on all audit findings.
(c)
(2)
(3)
(a)
(b)
(c)
(d)
(a)
(1) That the plan is in substantial noncompliance with the requirements of title XXI of the Act; or
(2) That the State is conducting its program in substantial noncompliance with either the State plan or the requirements of title XXI of the Act. (Hearings are generally not called until a reasonable effort has been made to resolve the issues through conferences and discussions. These efforts may be continued even if a date and place have been set for the hearing.)
(b)
(c)
(d)
(1)
(i) Of the findings of noncompliance;
(ii) The proposed enforcement actions to withhold payments; and
(iii) If enforcement action is proposed, that the State has a reasonable opportunity for correction, described in paragraph (d)(2) of this section, before the Administrator takes final action.
(2)
(3)
(i) Of the final determination on the findings of noncompliance;
(ii) If enforcement action is appropriate—
(A) No further payments will be made to the State (or that payments will be made only for those portions or aspects of the programs that are not affected by the noncompliance); and
(B) The total or partial withholding will continue until the Administrator is satisfied that the State's plan and practice are, and will continue to be, in compliance with Federal requirements.
(4)
(5) Withholding. CMS withholds payments, in whole or in part, until the Administrator is satisfied regarding the State's compliance.
Three distinct types of determinations are subject to Departmental reconsideration upon request by a State.
(a)
(b)
(c)
(a)
(b)
(2) After the clerk of the court files a copy of the petition with the Administrator, the Administrator files in the court the record of the proceedings on which the determination was based.
(c)
(2) The court has jurisdiction to affirm the Administrator's decision, to set it aside in whole or in part, or, for good cause, to remand the case for additional evidence.
(d)
(2) The Administrator certifies to the court the transcript and record of the further proceedings.
(e)
(a)
(1) The Regional Administrator or the Administrator questions its allowability and needs additional information in order to resolve the question; and
(2) CMS takes action to defer the claim (by excluding the claimed amount from the grant award) within 60 days after the receipt of a Quarterly Statement of Expenditures (prepared in accordance with CMS instructions) that includes that claim.
(b)
(i) Identifies the type and amount of the deferred claim and specifies the reason for deferral; and
(ii) Requests the State to make available all the documents and materials the CMS regional office believes are necessary to determine the allowability of the claim.
(2) It is the responsibility of the State to establish the allowability of a deferred claim.
(c)
(2) CMS regional office staff initiates review within 30 days after receipt of the documents and materials.
(3) If the Regional Administrator finds that the materials are not in readily reviewable form or that additional information is needed, he or she promptly notifies the State that it has 15 days to submit the readily reviewable or additional materials.
(4) If the State does not provide the necessary materials within 15 days, the
(5) The Regional Administrator has 90 days, after all documentation is available in readily reviewable form, to determine the allowability of the claim.
(6) If the Regional Administrator cannot complete review of the material within 90 days, CMS pays the claim, subject to a later determination of allowability.
(d)
(e)
(2) If the decision is to disallow, the notice informs the State of its right to reconsideration in accordance with 45 CFR part 16.
(a)
(1) The date or dates on which the State's claim for FFP was made.
(2) The time period during which the expenditures in question were made or claimed to have been made.
(3) The date and amount of any payment or notice of deferral.
(4) A statement of the amount of FFP claimed, allowed, and disallowed and the manner in which these amounts were computed.
(5) Findings of fact on which the disallowance determination is based or a reference to other documents previously furnished to the State or included with the notice (such as a report of a financial review or audit) that contain the findings of fact on which the disallowance determination is based.
(6) Pertinent citations to the law, regulations, guides and instructions supporting the action taken.
(7) A request that the State make appropriate adjustment in a subsequent expenditure report.
(8) Notice of the State's right to request reconsideration of the disallowance and the time allowed to make the request.
(9) A statement indicating that the disallowance letter is the Department's final decision unless the State requests reconsideration under paragraph (b)(2) of this section.
(b)
(2) A State may request reconsideration with a request to the Chair, Departmental Appeals Board, within 30 days after receipt of the disallowance letter, which must include—
(i) A copy of the disallowance letter;
(ii) A statement of the amount in dispute; and
(iii) A brief statement of why the disallowance is wrong.
(c)
(d)
(a)
(b)
(c)
(2)
(3) If the State does not refund the appropriate amount as specified in paragraph (c)(2) of this section, the amount will be disallowed.
(d)
(2)
(3) If the State does not refund the appropriate amount as specified in paragraph (d)(2) of this section, the amount will be disallowed.
(a)
(1) The amount to be repaid exceeds 2
(2) The State has given the Regional Administrator written notice, before total repayment was due, of its intent to repay by installments.
(b)
(1) If the State SCHIP program is ongoing, CMS uses the annual estimated State share of State SCHIP expenditures. This is the sum of the estimated State shares for four consecutive quarters, beginning with the quarter in which the first installment is to be paid, as shown on the State's latest CMS-21B form.
(2) If the State SCHIP program has been terminated by Federal law or by the State, CMS uses the actual State share. The actual State share is that shown on the State's Quarterly Statement of Expenditures reports for the last four quarters before the program was terminated.
(c)
(2)
(3)
(4)
(5)
(6)
(A) Suspend payments until the retroactive claim due the State has, in fact, been offset; or
(B) Continue payments until the reduced amount of its debt (remaining after the offset), has been paid in full. This second option would result in a shorter payment period.
(ii) A retroactive claim for the purpose of this regulation is a claim applicable to any period ending 12 months or more before the beginning of the quarter in which CMS would pay that claim.
(a) Funds from units of government may be considered as the State's share in claiming FFP if they meet the conditions specified in paragraphs (b) and (c) of this section.
(b) The funds from units of government are appropriated directly to the State or local Medicaid agency, or are transferred from other units of government (including Indian tribes) to the State or local agency and are under its administrative control, or are certified by the contributing unit of government as representing expenditures eligible for FFP under this section. Certified public expenditures must be expenditures within the meaning of 45 CFR 95.13 that are supported by auditable documentation in a form approved by the Secretary that, at a minimum—
(1) Identifies the relevant category of expenditures under the State plan;
(2) Explains whether the contributing unit of government is within the scope of the exception to limitations on provider-related taxes and donations;
(3) Demonstrates the actual expenditures incurred by the contributing unit of government in providing services to eligible individuals receiving medical assistance or in administration of the State plan; and
(4) Is subject to periodic State audit and review.
(c) The funds from units of government are not Federal funds, or are Federal funds authorized by Federal law to be used to match other Federal funds.
Claims for Federal financial participation in the cost of equipment under SCHIP are determined in accordance with subpart G of 45 CFR part 95. Requirements concerning the management and disposition of equipment under SCHIP are also prescribed in subpart G of 45 CFR part 95.
(a) No FFP is available for the following amounts, even when related to services or benefit coverage which is or could be provided under a State SCHIP program—
(1) Any cost sharing amounts that beneficiaries should have paid as enrollment fees, premiums, deductibles, coinsurance, copayments, or similar charges.
(2) Any amounts paid by the agency for health benefits coverage or services furnished to individuals who would not be eligible for that coverage or those services under the approved State child health plan, whether or not the individual paid any required premium or enrollment fee.
(b) The amount of expenditures under the State child health plan must be reduced by the amount of any premiums and other cost-sharing received by the State.
A State plan must provide that the SCHIP agency and, where applicable, local agencies administering the plan will—
(a) Maintain an accounting system and supporting fiscal records to assure that claims for Federal funds are in accord with applicable Federal requirements;
(b) Retain records for 3 years from date of submission of a final expenditure report;
(c) Retain records beyond the 3-year period if audit findings have not been resolved; and
(d) Retain records for nonexpendable property acquired under a Federal grant for 3 years from the date of final disposition of that property.
A State plan must provide that the single or appropriate SCHIP Agency will have an approved cost allocation plan on file with the Department in accordance with the requirements contained in subpart E of 45 CFR part 95. Subpart E also sets forth the effect on FFP if the requirements contained in that subpart are not met.
FFP is available for State ADP expenditures for the design, development, or installation of mechanized claims processing and information retrieval systems and for the operation of certain systems. Additional HHS regulations and CMS procedures regarding the availability of FFP for ADP expenditures are in 45 CFR part 74, 45 CFR part 95, subpart F, and part 11, State Medicaid Manual.
(a) Quarterly Federal payments to the States under title XXI (SCHIP) of the Act are to be reduced or increased to make adjustment for prior overpayments or underpayments that the Secretary determines have been made.
(b) The Secretary will consider the pro rata Federal share of the net amount recovered by a State during any quarter to be an overpayment.
(c) Allegations or indications of waste fraud and abuse with respect to the SCHIP program shall be referred promptly to the Office of Inspector General.
The SCHIP agency must assure appropriate audit of records on costs of provider services.
The SCHIP agency must maintain documentation of payment rates and make it available to HHS upon request.
(a)
(1) Section 2102 of the Act, which relates to eligibility standards and methodologies, coordination with other health insurance programs, and outreach and enrollment efforts to identify and enroll children who are eligible to participate in other public health insurance programs;
(2) Section 2105(c)(6)(B) of the Act, which relates to the prohibition against expenditures for child health assistance provided to children eligible for coverage under other Federal health care programs other than programs operated or financed by the Indian Health Service; and
(3) Section 2110(b) of the Act, which provides a definition of targeted low-income child.
(b)
(c)
As used in this subpart—
(1) In the case of a child on whose behalf a separate child health program application has been filed, the day on which a decision is made on that application; or
(2) In the case of a child on whose behalf an application for the separate child health program has not been filed, the last day of the month following the month in which the determination of presumptive eligibility was made.
(1) Furnishes health care items and services covered under the approved plan and is eligible to receive payments under the approved plan;
(2) Is authorized to determine eligibility of a child to participate in a Head Start program under the Head Start Act;
(3) Is authorized to determine eligibility of a child to receive child care services for which financial assistance is provided under the Child Care and Development Block Grant Act of 1990;
(4) Is authorized to determine eligibility of an infant or child to receive assistance under the special nutrition program for women, infants, and children (WIC) under section 17 of the Child Nutrition Act of 1966;
(5) Is authorized to determine eligibility of a child for medical assistance
(6) Is an elementary or secondary school, as defined in section 14101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 8801);
(7) Is an elementary or secondary school operated or supported by the Bureau of Indian Affairs;
(8) Is a State or Tribal child support enforcement agency;
(9) Is an organization that—
(i) Provides emergency food and shelter under a grant under the Stewart B. McKinney Homeless Assistance Act;
(ii) Is a State or Tribal office or entity involved in enrollment in the program under this title, Part A of title IV, or title XXI; or
(iii) Determines eligibility for any assistance or benefits provided under any program of public or assisted housing that receives Federal funds, including the program under section 8 or any other section of the United States Housing Act of 1937 (42 U.S.C. 1437) or under the Native American Housing Assistance and Self Determination Act of 1996 (25 U.S.C. 4101 et seq.); and
(10) Any other entity the State so deems, as approved by the Secretary.
The State plan must include a description of—
(a) The standards, consistent with §§ 457.310 and 457.320, used to determine the eligibility of children for coverage under the State plan.
(b) The State's policies governing enrollment and disenrollment; processes for screening applicant children for and, if eligible, facilitating their enrollment in Medicaid; and processes for implementing waiting lists and enrollment caps (if any).
(a)
(b)
(1)
(i) Has a family income at or below 200 percent of the Federal poverty line for a family of the size involved;
(ii) Resides in a State with no Medicaid applicable income level or;
(iii) Resides in a State that has a Medicaid applicable income level and has family income that either—
(A) Exceeds the Medicaid applicable income level for the age of such child, but not by more than 50 percentage points; or
(B) Does not exceed the income level specified for such child to be eligible for medical assistance under policies of the State plan under title XIX on June 1, 1997.
(2)
(i) Found eligible or potentially eligible for Medicaid under policies of the State plan (determined through either the Medicaid application process or the screening process described at § 457.350); or
(ii) Covered under a group health plan or under health insurance coverage, as defined in section 2791 of the Public Health Service Act, unless the plan or health insurance coverage program has been in operation since before July 1, 1997 and is administered by a State that receives no Federal funds for the program's operation. A child is not considered covered under a group health plan or health insurance coverage if the child does not have reasonable geographic access to care under that plan.
(3) For purposes of this section, policies of the State plan under title XIX plan include policies under a Statewide demonstration project under section
(i) Did not provide inpatient hospital coverage; or
(ii) Limited eligibility to children previously enrolled in Medicaid, imposed premiums as a condition of initial or continued enrollment, and did not impose a general time limit on eligibility.
(c)
(1)
(ii) A child is considered eligible for health benefits coverage under a State health benefits plan if a more than nominal contribution to the cost of health benefits coverage under a State health benefits plan is available from the State or public agency with respect to the child or would have been available from those sources on November 8, 1999. A contribution is considered more than nominal if the State or public agency makes a contribution toward the cost of an employee's dependent(s) that is $10 per family, per month, more than the State or public agency's contribution toward the cost of covering the employee only.
(2)
(i) An inmate of a public institution as defined at § 435.1010 of this chapter; or
(ii) A patient in an institution for mental diseases, as defined at § 435.1010 of this chapter, at the time of initial application or any redetermination of eligibility.
(a)
(1) Geographic area(s) served by the plan;
(2) Age (up to, but not including, age 19);
(3) Income;
(4) Resources;
(5) Spenddowns;
(6) Disposition of resources;
(7) Residency, in accordance with paragraph (d) of this section;
(8) Disability status, provided that such standards do not restrict eligibility;
(9) Access to, or coverage under, other health coverage; and
(10) Duration of eligibility, in accordance with paragraph (e) of this section.
(b)
(1) Cover children with a higher family income without covering children with a lower family income within any defined group of covered targeted low-income children;
(2) Deny eligibility based on a preexisting medical condition;
(3) Discriminate on the basis of diagnosis;
(4) Require any family member who is not requesting services to provide a social security number (including those family members whose income or resources might be used in making the child's eligibility determination);
(5) Exclude American Indian or Alaska Native children based on eligibility for, or access to, medical care funded by the Indian Health Service;
(6) Exclude individuals based on citizenship or nationality, to the extent that the children are U.S. citizens, U.S. nationals or qualified aliens, (as defined at section 431 of the Personal Responsibility and Work Opportunity Reconciliation Act (PRWORA) of 1996, as amended by the BBA of 1997, except to the extent that section 403 of PRWORA precludes them from receiving Federal means-tested public benefits); or
(7) Violate any other Federal laws or regulations pertaining to eligibility for a separate child health program under title XXI.
(c)
(d)
(1) Impose a durational residency requirement;
(2) Preclude the following individuals from declaring residence in a State—
(i) A non-institutionalized child who is not a ward of the State, if the child is physically located in that State, including as a result of the parent's or caretaker's employment in that State;
(ii) An institutionalized child who is not a ward of a State, if the State is the State of residence of the child's custodial parent's or caretaker at the time of placement;
(iii) A child who is a ward of a State, regardless of the child's physical location; or
(iv) A child whose custodial parent or caretaker is involved in work of a transient nature, if the State is the parent's or caretaker's home State.
(e)
(2) Eligibility must be redetermined at least every 12 months.
(a)
(b)
(c)
(d)
(2) A State must establish time standards for determining eligibility. These standards may not exceed forty-five calendar days (excluding days during which the application has been suspended, pursuant to § 457.350(f)(1)).
(3) In applying the time standards, the State must define “date of application” and must count each calendar day from the date of application to the day the agency mails or otherwise provides notice of its eligibility decision.
(e)
(1) If eligibility is approved, the notice must include information on the enrollee's rights and responsibilities under the program, including the opportunity for review of matters described in § 457.1130.
(2) If eligibility is denied, suspended or terminated, the State must provide notice in accordance with § 457.1180. In the case of a suspension or termination of eligibility, the State must provide sufficient notice to enable the child's parent or caretaker to take any appropriate actions that may be required to allow coverage to continue without interruption.
(f)
(a)
(1) The screening procedures that the State will use, at intake and any follow-up eligibility determination, including any periodic redetermination, to ensure that only targeted low-income children are furnished child health assistance under the plan; and
(2) The procedures that the State will use to ensure that the Medicaid application and enrollment process is initiated and that Medicaid enrollment is facilitated for children found, through the screening process, to be potentially eligible for Medicaid.
(b)
(2) Screening procedures must also identify any applicant or enrollee who would be potentially eligible for Medicaid services based on the eligibility of his or her mother under one of the poverty level groups described in section 1902(l) of the Act, section 1931 of the Act, or a Medicaid demonstration project approved under section 1115 of the Act.
(c)
(1)
(2)
(d)
(2) In conducting the screening, the State must apply Medicaid standards and methodologies related to resources for the particular Medicaid eligibility group, including all resource exclusions and disregards, except those that apply only in very limited circumstances.
(e)
(1) A statement that based on a limited review, the child does not appear eligible for Medicaid, but Medicaid eligibility can only be determined based on a full review of a Medicaid application under all Medicaid eligibility groups;
(2) Information about Medicaid eligibility and benefits; and
(3) Information about how and where to apply for Medicaid under all eligibility groups.
(4) The State will determine the written format and timing of the information regarding Medicaid eligibility,
(f)
(1) Except as provided in § 457.355, find the child ineligible, provisionally ineligible, or suspend the child's application for the separate child health program unless and until a completed Medicaid application for that child is denied, or the child's circumstances change, and promptly transmit the separate child health application to the Medicaid agency as provided in paragraph (f)(3)(ii) of this section; and
(2) If a State uses a joint application for its Medicaid and separate child health programs, promptly transmit the application, or the information obtained through the application, and all relevant documentation to the Medicaid agency; or
(3) If a State does not use a joint application for its Medicaid and separate child health programs:
(i) Promptly inform the child's parent or caretaker in writing and, if appropriate, orally that the child has been found likely to be eligible for Medicaid; provide the family with a Medicaid application and offer information about what, if any, further information, documentation, or other steps are needed to complete the Medicaid application process; and offer assistance in completing the application process;
(ii) Promptly transmit the separate child health program application; or the information obtained through the application, and all other relevant information and documentation, including the results of the screening process, to the Medicaid agency for a final determination of Medicaid eligibility in accordance with the requirements of §§ 431.636 and 457.1110 of this chapter; or
(4) Establish other effective and efficient procedures, in coordination with the Medicaid agency, as described and approved in the State plan that ensure that children who are screened as potentially eligible for Medicaid are able to apply for Medicaid without delay and, if eligible, are enrolled in Medicaid in a timely manner; and
(5) Determine or redetermine eligibility for the separate child health program, if—
(i) The State is notified pursuant to § 431.636 of this chapter that the child has been found ineligible for Medicaid, consistent with the time standards established pursuant to § 457.340(c); or
(ii) The State is notified prior to the final Medicaid eligibility determination that the child's circumstances have changed and another screening shows that the child is not likely to be eligible for Medicaid.
(g)
(1) The State's Medicaid program, including the benefits covered, and restrictions on cost sharing; and
(2) Eligibility rules that prohibit children who have been screened eligible for Medicaid from being enrolled in a separate child health program, other than provisional temporary enrollment while a final Medicaid eligibility determination is being made.
(3) The State will determine the written format and timing of the information regarding Medicaid eligibility, benefits, and the application process required under this paragraph (g).
(h)
(1) The procedures developed in accordance with this section have been followed for each child applying for a separate child health program before placing the child on a waiting list or otherwise deferring action on the child's application for the separate child health program; and
(2) Families are informed that a child may be eligible for Medicaid if circumstances change while the child is on a waiting list for separate child health program.
States must monitor and establish a mechanism to evaluate the screen and enroll process described at § 457.350 to ensure that children who are screened potentially eligible for Medicaid are enrolled in Medicaid, if eligible, and that children who are found ineligible for Medicaid are enrolled in the separate child health program, if eligible.
(a)
(b)
(a) The State must establish procedures to ensure the integrity of the eligibility determination process.
(b) A State may establish reasonable eligibility verification mechanisms to promote enrollment of eligible children and may permit applicants and enrollees to demonstrate that they meet eligibility requirements through self-declaration or affirmation except that a State may permit self-declaration of citizenship only if the State has effective, fair and non-discriminatory procedures to ensure the integrity of the application process in accordance with § 457.320(c).
(a)
(1) Section 2102(a)(7) of the Act, which requires that States make assurances relating to, the quality and appropriateness of care, and access to covered services;
(2) Section 2103 of the Act, which outlines coverage requirements for children's health insurance;
(3) Section 2109 of the Act, which describes the relation of the SCHIP program to other laws;
(4) Section 2110(a) of the Act, which describes child health assistance; and
(5) Section 2110(c) of the Act, which contains definitions applicable to this subpart.
(b)
(c)
For the purpose of this subpart, the term “child health assistance” means payment for part or all of the cost of health benefits coverage provided to targeted low-income children for the following services:
(a) Inpatient hospital services.
(b) Outpatient hospital services.
(c) Physician services.
(d) Surgical services.
(e) Clinic services (including health center services) and other ambulatory health care services.
(f) Prescription drugs and biologicals and the administration of these drugs and biologicals, only if these drugs and biologicals are not furnished for the purpose of causing, or assisting in causing, the death, suicide, euthanasia, or mercy killing of a person.
(g) Over-the-counter medications.
(h) Laboratory and radiological services.
(i) Prenatal care and pre-pregnancy family planning services and supplies.
(j) Inpatient mental health services, other than services described in paragraph (r) of this section but including services furnished in a State-operated mental hospital and including residential or other 24-hour therapeutically planned structured services.
(k) Outpatient mental health services, other than services described in paragraph (s) of this section but including services furnished in a State-operated mental hospital and including community-based services.
(l) Durable medical equipment and other medically-related or remedial devices (such as prosthetic devices, implants, eyeglasses, hearing aids, dental devices and adaptive devices).
(m) Disposable medical supplies.
(n) Home and community-based health care services and related supportive services (such as home health nursing services, personal care, assistance with activities of daily living, chore services, day care services, respite care services, training for family members and minor modification to the home.)
(o) Nursing care services (such as nurse practitioner services, nurse midwife services, advanced practice nurse services, private duty nursing, pediatric nurse services and respiratory care services) in a home, school, or other setting.
(p) Abortion only if necessary to save the life of the mother or if the pregnancy is the result of rape or incest.
(q) Dental services.
(r) Inpatient substance abuse treatment services and residential substance abuse treatment services.
(s) Outpatient substance abuse treatment services.
(t) Case management services.
(u) Care coordination services.
(v) Physical therapy, occupational therapy, and services for individuals with speech, hearing and language disorders.
(w) Hospice care.
(x) Any other medical, diagnostic, screening, preventive, restorative, remedial, therapeutic, or rehabilitative services (whether in a facility, home, school, or other setting) if recognized by State law and only if the service is—
(1) Prescribed by or furnished by a physician or other licensed or registered practitioner within the scope of practice as defined by State law;
(2) Performed under the general supervision or at the direction of a physician; or
(3) Furnished by a health care facility that is operated by a State or local government or is licensed under State law and operating within the scope of the license.
(y) Premiums for private health care insurance coverage.
(z) Medical transportation.
(aa) Enabling services (such as transportation, translation, and outreach services) only if designed to increase the accessibility of primary and preventive health care services for eligible low-income individuals.
(bb) Any other health care services or items specified by the Secretary and not excluded under this subchapter.
(a)
(1) Benchmark coverage in accordance with § 457.420.
(2) Benchmark-equivalent coverage in accordance with § 457.430.
(3) Existing comprehensive State-based coverage in accordance with § 457.440.
(4) Secretary-approved coverage in accordance with § 457.450.
(b)
(1) Well-baby and well-child care services as defined by the State;
(2) Age-appropriate immunizations in accordance with the recommendations of the Advisory Committee on Immunization Practices (ACIP); and
(3) Emergency services as defined in § 457.10.
Benchmark coverage is health benefits coverage that is substantially equal to the health benefits coverage in one of the following benefit plans:
(a)
(b)
(c)
(a)
(b)
(1) Inpatient and outpatient hospital services.
(2) Physicians' surgical and medical services.
(3) Laboratory and x-ray services.
(c)
(2) If the benchmark coverage package used by the State for purposes of comparison in establishing the aggregate actuarial value of the benchmark-equivalent coverage package includes coverage for prescription drugs, mental health services, vision services or hearing services, then the actuarial value of the coverage for each of these categories of service in the benchmark-equivalent coverage package must be at least 75 percent of the value of the coverage for such a category or service in the benchmark plan used for comparison by the State.
(3) If the benchmark coverage package does not cover one of the categories of services in paragraph (c)(2) of this section, then the benchmark-equivalent coverage package may, but is not required to, include coverage for that category of service.
(a) To obtain approval for benchmark-equivalent health benefits coverage described under § 457.430, the State must submit to CMS an actuarial report that contains an actuarial opinion that the health benefits coverage meets the actuarial requirements under § 457.430. The report must also specify the benchmark coverage used for comparison.
(b) The actuarial report must state that it was prepared—
(1) By an individual who is a member of the American Academy of Actuaries;
(2) Using generally accepted actuarial principles and methodologies of the American Academy of Actuaries;
(3) Using a standardized set of utilization and price factors;
(4) Using a standardized population that is representative of privately insured children of the age of those expected to be covered under the State plan;
(5) Applying the same principles and factors in comparing the value of different coverage (or categories of services);
(6) Without taking into account any differences in coverage based on the method of delivery or means of cost control or utilization used; and
(7) Taking into account the ability of a State to reduce benefits by considering the increase in actuarial value of health benefits coverage offered under the State plan that results from the limitations on cost sharing (with the exception of premiums) under that coverage.
(c) The actuary who prepares the opinion must select and specify the standardized set and population to be
(d) The State must provide sufficient detail to explain the basis of the methodologies used to estimate the actuarial value or, if requested by CMS, to replicate the State's result.
(a)
(1) Includes coverage of a range of benefits;
(2) Is administered or overseen by the State and receives funds from the State;
(3) Is offered in the State of New York, Florida or Pennsylvania; and
(4) Was offered as of August 5, 1997.
(b)
(1) The program continues to include a range of benefits;
(2) The State submits an actuarial report demonstrating that the modification does not reduce the actuarial value of the coverage under the program below the lower of either—
(i) The actuarial value of the coverage under the program as of August 5, 1997; or
(ii) The actuarial value of a benchmark benefit package as described in § 457.430 evaluated at the time the modification is requested.
Secretary-approved coverage is health benefits coverage that, in the determination of the Secretary, provides appropriate coverage for the population of targeted low-income children covered under the program. Secretary-approved coverage, for which no actuarial analysis is required, may include, but is not limited to the following:
(a) Coverage that is the same as the coverage provided to children under the Medicaid State plan.
(b) Comprehensive coverage for children offered by the State under a Medicaid demonstration project approved by the Secretary under section 1115 of the Act.
(c) Coverage that either includes the full Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) benefit or that the State has extended to the entire Medicaid population in the State.
(d) Coverage that includes benchmark health benefits coverage, as specified in § 457.420, plus any additional coverage.
(e) Coverage that is the same as the coverage provided under § 457.440.
(f) Coverage, including coverage under a group health plan purchased by the State, that the State demonstrates to be substantially equivalent to or greater than coverage under a benchmark health benefits plan, as specified in § 457.420, through use of a benefit-by-benefit comparison which demonstrates that coverage for each benefit meets or exceeds the corresponding coverage under the benchmark health benefits plan.
A State is not required to provide health benefits coverage under the plan for an item or service for which payment is prohibited under title XXI even if any benchmark health benefits plan includes coverage for that item or service.
(a)
(b)
(2)
(c)
(2) If a State wishes to have managed care entities provide abortions in addition to those specified in paragraph (b) of this section, those abortions must be provided under a separate contract using non-Federal funds. A State may not set aside a portion of the capitated rate paid to a managed care entity to be paid with State-only funds, or append riders, attachments or addenda to existing contracts with managed care entities to separate the additional abortion services from the other services covered by the contract.
(3) Nothing in this section affects the expenditure by a State, locality, or private person or entity of State, local, or private funds (other than those expended under the State plan) for any abortion services or for health benefits coverage that includes coverage of abortion services.
(a)
(2) If the State obtains health benefits coverage through payment or a contract for health benefits coverage under a group health plan or group health insurance coverage, the State may permit the imposition of a pre-existing condition exclusion but only to the extent that the exclusion is permitted under the applicable provisions of part 7 of subtitle B of title I of the Employee Retirement Income Security Act of 1974 (ERISA) and title XXVII of the Public Health Service Act.
(b)
(2)
(3)
(4)
A State that elects to obtain health benefits coverage through a separate child health program must include in its State plan a description of the child health assistance provided under the plan for targeted low-income children, including a description of the proposed methods of delivery and utilization control systems. A State must—
(a) Describe the methods of delivery of child health assistance including the choice of financing and the methods for assuring delivery of the insurance products and delivery of health care services covered by such products to the enrollees, including any variations; and
(b) Describe utilization control systems designed to ensure that enrollees receiving health care services under the State plan receive only appropriate and medically necessary health care consistent with the benefit package described in the approved State plan.
A State plan must include a description of the methods that a State uses for assuring the quality and appropriateness of care provided under the
(a) Access to well-baby care, well-child care, well-adolescent care and childhood and adolescent immunizations.
(b) Access to covered services, including emergency services as defined at § 457.10.
(c) Appropriate and timely procedures to monitor and treat enrollees with chronic, complex, or serious medical conditions, including access to an adequate number of visits to specialists experienced in treating the specific medical condition and access to out-of-network providers when the network is not adequate for the enrollee's medical condition.
(d) That decisions related to the prior authorization of health services are completed as follows:
(1) In accordance with the medical needs of the patient, within 14 days after receipt of a request for services. A possible extension of up to 14 days may be permitted if the enrollee requests the extension or if the physician or health plan determines that additional information is needed; or
(2) In accordance with existing State law regarding prior authorization of health services.
(a)
(1) Section 2101(a) of the Act, which provides that the purpose of title XXI is to provide funds to States to enable them to initiate and expand the provision of child health assistance to uninsured, low-income children in an effective and efficient manner; and
(2) Section 2103(e) of the Act, which sets forth provisions regarding State plan requirements and options for cost sharing.
(b)
(c)
The State plan must include a description of—
(a) The amount of premiums, deductibles, coinsurance, copayments, and other cost sharing imposed;
(b) The methods, including the public schedule, the State uses to inform enrollees, applicants, providers and the general public of the cost-sharing charges, the cumulative cost-sharing maximum, and any changes to these amounts;
(c) The disenrollment protections as required under § 457.570;
(d) In the case of coverage obtained through premium assistance for group health plans—
(1) The procedures the State uses to ensure that eligible children are not charged copayments, coinsurance, deductibles or similar fees on well-baby and well-child care services described at § 457.520, and that any cost sharing complies with the requirements of this subpart;
(2) The procedures to ensure that American Indian and Alaska Native children are not charged premiums, copayments, coinsurance, deductibles, or similar fees in accordance with § 457.535;
(3) The procedures to ensure that eligible children are not charged cost sharing in excess of the cumulative cost-sharing maximum specified in § 457.560.
(e) Procedures that do not primarily rely on a refund given by the State for overpayment on behalf of an eligible child to ensure compliance with this subpart.
When a State imposes premiums, enrollment fees, or similar fees on enrollees, the State plan must describe—
(a) The amount of the premium, enrollment fee or similar fee imposed on enrollees;
(b) The time period for which the charge is imposed;
(c) The group or groups that are subject to the premiums, enrollment fees, or similar charges;
(d) The consequences for an enrollee or applicant who does not pay a charge, and the disenrollment protections adopted by the State in accordance with § 457.570; and
(e) The methodology used to ensure that total cost-sharing liability for a family does not exceed the cumulative cost-sharing maximum specified in § 457.560.
To impose copayments, coinsurance, deductibles or similar charges on enrollees, the State plan must describe—
(a) The service for which the charge is imposed;
(b) The amount of the charge;
(c) The group or groups of enrollees that may be subject to the cost-sharing charge;
(d) The consequences for an enrollee who does not pay a charge, and the disenrollment protections adopted by the State in accordance with § 457.570;
(e) The methodology used to ensure that total cost-sharing liability for a family does not exceed the cumulative cost-sharing maximum specified in § 457.560; and
(f) An assurance that enrollees will not be held liable for cost-sharing amounts for emergency services that are provided at a facility that does not participate in the enrollee's managed care network beyond the copayment amounts specified in the State plan for emergency services as defined in § 457.10.
(a) A State may not impose copayments, deductibles, coinsurance or other cost sharing with respect to the well-baby and well-child care services covered under the State plan in either the managed care delivery setting or the fee-for-service delivery setting.
(b) For the purposes of this subpart, at a minimum, any of the following services covered under the State plan will be considered well-baby and well-child care services:
(1) All healthy newborn physician visits, including routine screening, whether provided on an inpatient or outpatient basis.
(2) Routine physical examinations as recommended and updated by the American Academy of Pediatrics (AAP) “Guidelines for Health Supervision III” and described in “Bright Futures: Guidelines for Health Supervision of Infants, Children and Adolescents.”
(3) Laboratory tests associated with the well-baby and well-child routine physical examinations as described in paragraph (b)(2) of this section.
(4) Immunizations and related office visits as recommended and updated by the Advisory Committee on Immunization Practices (ACIP).
(5) Routine preventive and diagnostic dental services (such as oral examinations, prophylaxis and topical fluoride applications, sealants, and x-rays) as described in the most recent guidelines issued by the American Academy of Pediatric Dentistry (AAPD).
(a) The State must make available to the groups in paragraph (b) of this section a public schedule that contains the following information:
(1) Current cost-sharing charges.
(2) Enrollee groups subject to the charges.
(3) Cumulative cost-sharing maximums.
(4) Mechanisms for making payments for required charges.
(5) The consequences for an applicant or an enrollee who does not pay a charge, including the disenrollment protections required by § 457.570.
(b) The State must make the public schedule available to the following groups:
(1) Enrollees, at the time of enrollment and reenrollment after a redetermination of eligibility, and when cost-sharing charges and cumulative cost-sharing maximums are revised.
(2) Applicants, at the time of application.
(3) All participating providers.
(4) The general public.
The State may vary premiums, deductibles, coinsurance, copayments or any other cost sharing based on family income only in a manner that does not favor children from families with higher income over children from families with lower income.
States may not impose premiums, deductibles, coinsurance, copayments or any other cost-sharing charges on children who are American Indians or Alaska Natives, as defined in § 457.10.
The State may impose premiums, enrollment fees, deductibles, copayments, coinsurance, cost sharing and other similar charges for children whose family income is at or below 150 percent of the FPL as long as—
(a) Aggregate monthly enrollment fees, premiums, or similar charges imposed on a family are less than or equal to the maximum amounts permitted under § 447.52 of this chapter for a Medicaid eligible family of the same size and income;
(b) Any copayments, coinsurance, deductibles or similar charges for children whose family income is at or below 100 percent of the FPL are equal to or less than the amounts permitted under § 447.54 of this chapter;
(c) For children whose family income is from 101 percent to 150 percent of the FPL, any copayments, coinsurance, deductibles or similar charges are equal to or less than the maximum amounts permitted under § 457.555;
(d) The State does not impose more than one type of cost-sharing charge (deductible, copayment, or coinsurance) on a service;
(e) The State only imposes one copayment based on the total cost of services furnished during one office visit; and
(f) Aggregate annual cost sharing of all types, with respect to all targeted low-income children in a family, does not exceed the maximum permitted under § 457.560(a).
(a)
(1) Any copayment or similar charge the State imposes under a fee-for-service delivery system does not exceed the following amounts:
(2) Any copayment that the State imposes for services provided by a managed care organization may not exceed $5.00 per visit;
(3) Any coinsurance rate the State imposes may not exceed 5 percent of the payment the State directly or through contract makes for the service; and
(4) Any deductible the State imposes may not exceed $3.00 per month, per family for each period of eligibility.
(b)
(c)
(d)
(e)
At 73 FR 71854, Nov. 25, 2008, § 457.555 was amended by revising (a) introductory text, and (1), (2), (4), (c) and (d), effective March 27, 2009. At 74 FR 4888, March 27, 2009, the effective date was delayed until Dec. 31, 2009. For the convenience of the user, the revised text is set forth as follows:
(a)
(1)(i) For Federal FY 2009, any co-payment or similar charge the State imposes under a fee-for-service delivery system may not exceed the following amounts:
(ii) Thereafter, any copayments may not exceed these amounts as updated each October 1 by the percentage increase in the medical care component of the CPI-U for the period of September to September ending in the preceding calendar year and then rounded to the next higher 5-cent increment.
(2) For Federal FY 2009, any co-payment that the State imposes for services provided by a managed care organization may not exceed $5.70 per visit. Thereafter, any copayment may not exceed this amount as updated each October 1 by the percentage increase in the medical care component of the CPI-U for the period of September to September ending in the preceding calendar year and then rounded to the next higher 5-cent increment.
(4) For Federal FY 2009, any deductible the State imposes may not exceed $3.40 per month, per family for each period of eligibility. Thereafter, any deductible may not exceed this amount as updated each October 1 by the percentage increase in the medical care component of the CPI-U for the period of September to September ending in the preceding calendar year and then rounded to the next higher 5-cent increment.
(c)
(d)
(a) A State may not impose premiums, enrollment fees, copayments, coinsurance, deductibles, or similar
(b) The State must inform the enrollee's family in writing and orally if appropriate of their individual cumulative cost-sharing maximum amount at the time of enrollment and reenrollment.
(a) The State must give enrollees reasonable notice of and an opportunity to pay past due premiums, copayments, coinsurance, deductibles or similar fees prior to disenrollment.
(b) The disenrollment process must afford the enrollee an opportunity to show that the enrollee's family income has declined prior to disenrollment for non payment of cost-sharing charges, and in the event that such a showing indicates that the enrollee may have become eligible for Medicaid or for a lower level of cost sharing, the State must facilitate enrolling the child in Medicaid or adjust the child's cost-sharing category as appropriate.
(c) The State must provide the enrollee with an opportunity for an impartial review to address disenrollment from the program in accordance with § 457.1130(a)(3).
This subpart interprets and implements—
(a) Section 2104 of the Act which specifies the total allotment amount available for allotment to each State for child health assistance for fiscal years 1998 through 2007, the formula for determining each State allotment for a fiscal year, including the Commonwealth and Territories, and the amounts of payments for expenditures that are applied to reduce the State allotments.
(b) Section 2105 of the Act which specifies the provisions for making payment to States, the limitations and conditions on such payments, and the calculation of the enhanced Federal medical assistance percentage.
The provisions of this subpart apply to the 50 States and the District of Columbia, and the Commonwealths and Territories.
(a)
(1) For fiscal years 1998 and 1999, the State child health plan must be approved before October 1, 1999;
(2) For fiscal years after 1999, the State child health plan must be approved by the end of the fiscal year;
(3) An allotment for a fiscal year is not available to a State prior to the beginning of the fiscal year; and
(4) Federal payments out of an allotment are based on State expenditures which are allowable under the approved State child health plan.
(b) Federal payments for States' Children's Health Insurance Program (SCHIP) expenditures under an approved State child health plan are—
(1) Limited to the amount of available funds remaining in State allotments calculated in accordance with the allotment process and formula specified in §§ 457.608 and 457.610, and payment process in §§ 457.614 and 457.616.
(2) Available based on a percentage of State SCHIP expenditures, at a rate equal to the enhanced Federal medical assistance percentage (FMAP) for each fiscal year, calculated in accordance with § 457.622.
(3) Available through the grants process specified in § 457.630.
(a)
(2) In order to determine each State allotment, CMS determines the national total allotment amount for each fiscal year available to the 50 States and the District of Columbia, as described in paragraph (c) of this section, and the total allotment amount available for each fiscal year for allotment to the Commonwealths and Territories, as described in paragraph (d) of this section.
(3) The amount of allotments redistributed under section 2104(f) of the Act will not be applied or taken into account in determining the amounts of a fiscal year allotment for a State and the District of Columbia under this section.
(b)
(c)
(i) The total allotment amount available for allotment for each fiscal year to the Commonwealths and Territories, as determined in paragraph (d)(1) of this section;
(ii) The total amount of the grant for the fiscal year for children with Type I Diabetes under Section 4921 of Public Law 105-33. This is $30,000,000 for each of the fiscal years 1998 through 2002; and
(iii) The total amount of the grant for the fiscal year for diabetes programs for Indians under Section 4922 of Public Law 105-33. This is $30,000,000 for each of the fiscal years 1998 through 2002.
(2) The following formula illustrates the calculation of the national total allotment amount available for allotment to the 50 States and the District of Columbia for a fiscal year:
(d)
(2)
(e)
(i) The proportion for the State or the District of Columbia for the fiscal year, as defined in paragraph (b) of this
(ii)(A) The national total allotment amount available for allotment for the fiscal year, as specified in paragraph (c) of this section. The State and the District of Columbia's allotment for a fiscal year is determined in accordance with the following general formula:
(B) There are two steps for determining the proportion for a State and the District of Columbia. The first step determines the preadjusted proportions, and is described under paragraph (e)(2) of this section. The first step applies in determining the proportion for all fiscal years. The second step applies floors and ceilings and, if necessary, applies a reconciliation to the preadjusted proportion. The second step is described in paragraph (e)(3) of this section. The second step applies in determining the proportion only for FY 2000 and subsequent fiscal years. For FY 1998 and FY 1999, the preadjusted proportion is the State or District of Columbia's proportion for the fiscal year.
(2)
(ii) For each of the fiscal years 1998 and 1999, the number of children is equal to the number of low-income children in the State for the fiscal year with no health insurance coverage. For fiscal year 2000, the number of children is equal to the sum of 75 percent of the number of low-income children in the State for the fiscal year with no health insurance coverage and 25 percent of the number of low-income children in the State for the fiscal year. For fiscal years 2001 and thereafter, the number of children is equal to the sum of 50 percent of the number of low-income children in the State for the fiscal year with no health insurance coverage and 50 percent of the number of low-income children in the State for the fiscal year. (section 2104(b)(2)(A) of the Act).
(3)
(A) The proportion floors, or minimum proportions, that apply in determining a State's proportion for the fiscal year are:
(
(
(
(B) The proportion ceiling, or maximum proportion, for a fiscal year that applies in determining the State's fiscal year proportion is 145 percent of the State's proportion for FY 1999.
(ii)
(A) If, after the application of the floors and ceilings under paragraphs (e)(3)(i)(A) and (B) of this section, the sum of the States' proportions is greater than one, the Secretary will establish a maximum percentage increase in States' proportions, such that when applied to the States' proportions, the sum of the proportions is exactly equal to one.
(B) If, after the application of the floors and ceilings under paragraphs (e)(3)(i)(A) and (B), the sum of the proportions is less than one, the Secretary will increase States' proportions (as computed before the application of the floors under paragraph (e)(3)(i)(A)) in a pro rata manner (but not to exceed the 145 percent ceiling computed under paragraph (e)(3)(i)(B)), such that when applied to the States' proportions, the sum of the proportions is exactly equal to one.
(4)
(5)
(f)
(g)
(2) For FY 1998 and FY 1999, CMS determined and published the State reserved allotments using the available data described in paragraphs (e)(4) and (e)(5) of this section, respectively, on the basis of the statutory allotment formula as it existed prior to the enactment of Public Law 106-113.
(3) If all States, the District of Columbia, and the Commonwealths and Territories have approved State child health plans in place prior to the beginning of the fiscal year, as appropriate, CMS may publish the allotments as final in the
(h)
(2) Final State allotments for a fiscal year after FY 1999 for each State, the District of Columbia, and the Commonwealths and Territories are determined by CMS based only on those States, the District of Columbia, and the Commonwealths and Territories that have approved State child health plans by the end of the fiscal year, in accordance with the formula and methodology specified in paragraphs (a) through (g) of this section.
(3) CMS determines and publishes the States' final fiscal year allotments in the
The amount of a final allotment for a fiscal year, as determined under § 457.608(h) and reduced to reflect certain Medicaid expenditures in accordance with § 457.616, remains available until expended for Federal payments based on expenditures claimed during a 3-year period of availability, beginning with the fiscal year of the final allotment and ending with the end of the second fiscal year following the fiscal year.
(a) A State may make claims for Federal payment based on expenditures incurred by the State prior to or during the period of availability related to that fiscal year.
(b) In order to receive Federal financial participation (FFP) for a State's claims for payment for the State's expenditures, a State must—
(1) Submit budget estimates of quarterly funding requirements for Medicaid and the State Children's Health Insurance Programs; and
(2) Submit an expenditure report.
(c) Based on the State's quarterly budget estimates, CMS—
(1) Issues an advance grant to a State as described in § 457.630;
(2) Tracks and applies Federal payments claimed quarterly by each State, the District of Columbia, and each Commonwealth and Territory to ensure that payments do not exceed the applicable allotments for the fiscal year; and
(3) Track and apply relevant State, District of Columbia, Commonwealth and Territory expenditures reported each quarter against the 10 percent limit on expenditures other than child health assistance for standard benefit package, on a fiscal year basis as specified in § 457.618.
(a)
(1) Payments made to the State for expenditures claimed during the fiscal year under its title XIX Medicaid program, to the extent the payments were made on the basis of the enhanced FMAP described in sections 1905(b) and 2105(b) of the Act for expenditures attributable to children described in section 1905(u)(2) of the Act.
(2) Payments made to the State for expenditures claimed during the fiscal year under its title XIX Medicaid program, to the extent the payments were made on the basis of the enhanced FMAP described in sections 1905(b) and 2105(b) of the Act for expenditures attributable to children described in section 1905(u)(3) of the Act.
(3) Payments made to a State under section 1903(a) of the Act for expenditures claimed by the State during a fiscal year that are attributable to the provision of medical assistance to a child during a presumptive eligibility period under section 1920A of the Act.
(4) Payments made to a State under its title XXI State Children's Health Insurance Program with respect to section 2105(a) of the Act for expenditures claimed by the State during a fiscal year.
(b)
(1) Coordinate the application of the payments made to a State for the State's expenditures claimed under the Medicaid and State Children's Health Insurance programs against the State allotment for a fiscal year;
(2) Determine the order of these payments in that application; and
(3) Determine the application of payments against multiple State Child Health Insurance Program fiscal year allotments.
(c)
(1) Applies the payments attributable to Medicaid expenditures specified in paragraphs (a)(1) through (a)(3) of this section, against the State child health plan allotment for a fiscal year before State child health plan expenditures specified in paragraph (a)(4) of this section are applied.
(2) Applies the payments attributable to Medicaid and State child health plan expenditures specified in paragraph (a) of this section against the applicable allotments for a fiscal year based on the quarter in which the expenditures are claimed by the State.
(3) Applies payments against the State allotments for a fiscal year in a manner that is consistent for all States.
(4) Applies payments attributable to Medicaid expenditures specified in paragraphs (a)(1) through (a)(3) of this section, in an order that maximizes Federal reimbursement for States. Expenditures for which the enhanced FMAP is available are applied before expenditures for which the regular FMAP is available.
(5) Applies payments for expenditures against State Child Health Insurance Program fiscal year allotments in the least administratively burdensome, and most effective and efficient manner; payments are applied on a quarterly basis as they are claimed by the State, and are applied to reduce the earliest fiscal year State allotments before the payments are applied to reduce later fiscal year allotments.
(6) Subject to paragraphs (c)(6)(i) and (ii) of this section, applies payments for expenditures for a fiscal year's allotment against a subsequent fiscal year's allotment; however, the subsequent fiscal year's allotment must be available at the time of application. For example, if the allotment for fiscal year 1998 has been fully expended, payments for expenditures claimed in fiscal year 1998 are carried over for application against the fiscal year 1999 allotment when it becomes available.
(i) In accordance with § 457.618, the amount of non-primary expenditures that are within the 10 percent limit for the fiscal year for which they are claimed may be applied against a fiscal year allotment or allotments available in a subsequent fiscal year.
(ii) In accordance with § 457.618, the amounts of non-primary expenditures that exceed the 10 percent limit for the fiscal year for which they are claimed may not be applied against a fiscal
(7) Carries over unexpended amounts of a State's allotment for a fiscal year for use in subsequent fiscal years through the end of the 3-year period of availability. For example, if the amounts of the fiscal year 1998 allotment are not fully expended by the end of fiscal year 1998, these amounts are carried over to fiscal year 1999 and are available to provide FFP for expenditures claimed by the State for that fiscal year.
(d)
(a)
(2)
(i) Administrative expenditures;
(ii) Outreach;
(iii) Health initiatives; and
(iv) Certain other child health assistance.
(b)
(c)
(1) Applied on an annual fiscal year basis;
(2) Calculated based on the total computable expenditures claimed by the State on quarterly expenditure reports submitted for a fiscal year. Expenditures claimed on a quarterly report for a different fiscal year may not be used in the calculation; and
(3) Calculated using the following formula:
(d) The expenditures under section 2105(a)(2) of the Act that are subject to the 10 percent limit are applied—
(1) On an annual fiscal year basis; and
(2) Against the 10 percent limit in the fiscal year for which the State submitted a quarterly expenditure report including the expenditures. Expenditures claimed on a quarterly report for one fiscal year may not be applied against the 10 percent limit for any other fiscal year.
(e)(1) The 10 percent limit for a fiscal year, as calculated under paragraph (c)(3) of this section, may be no greater than 10 percent of the total computable amount (determined under paragraph
(2) As used in paragraph (e)(1) of this section, the total computable amount of a State's allotment for a fiscal year is determined by dividing the State's allotment for the fiscal year by the State's enhanced FMAP for the year. For example, if a State allotment for a fiscal year is $65 million and the enhanced FMAP rate for the fiscal year is 65 percent, the total computable amount of the allotment for the fiscal year is $100 million ($65 million/.65). In this example, the 10 percent limit may be no greater than a total computable amount of $10 million (10 percent of $100 million).
(a)
(b)
(1) 70 percent of the regular FMAP determined under section 1905(b) of the Act, plus 30 percentage points; or
(2) 85 percent.
(c)
(1) The State has an approved title XXI State child health plan;
(2) The expenditures are allowable under the State's approved title XXI State child health plan;
(3) State allotment amounts are available in the fiscal year, that is, the State's allotment or allotments (as reduced in accordance with § 457.616) remain available for a fiscal year and have not been fully expended.
(4) Expenditures claimed against the 10 percent limit are within the State's 10 percent limit for the fiscal year.
(5) For States that elect to extend eligibility to unborn children under the approved Child Health Plan, the State does not adopt eligibility standards and methodologies for purposes of determining a child's eligibility under the Medicaid State plan that were more restrictive than those applied under policies of the State plan in effect on June 1, 1997. This limitation applies also to more restrictive standards and methodologies for determining eligibility for services for a child based on the eligibility of a pregnant woman.
(d)
(1) Child health assistance under the plan for targeted low-income children in the form of providing health benefits coverage that meets the requirements of section 2103 of the Act; and
(2) Subject to the 10 percent limit provisions under § 457.618(a)(2), the following expenditures:
(i) Payment for other child health assistance for targeted low-income children;
(ii) Expenditures for health services initiatives under the State child health assistance plan for improving the health of children (including targeted low-income children);
(iii) Expenditures for outreach activities; and
(iv) Other reasonable costs incurred by the State to administer the State child health assistance plan.
(e)
(2)
(3) FFP is not available in expenditures for administrative activities for items or services included within the scope of another claimed expenditure.
(4) FFP is available in expenditures for activities defined in sections 2102(c)(1) and 2105(a)(2)(C) of the Act as outreach to families of children likely to be eligible for child health assistance under the plan or under other public or private health coverage programs to inform these families of the availability of, and to assist them in enrolling their children in such a program.
(5) FFP is available in administrative expenditures for activities specified in sections 2102(c)(2) of the Act as coordination of the administration of the State Children's Health Insurance Program with other public and private health insurance programs. FFP would not be available for the costs of administering the other public and private health insurance programs. Coordination activities must be distinguished from other administrative activities common among different programs.
(a)
(1) A non-governmental health insurer would have been obligated to pay for those services but for a provision of its insurance contract that has the effect of limiting or excluding those obligations based on the actual or potential eligibility of the individual for child health assistance under the State child health insurance plan.
(2) Payment has been made or can reasonably be expected to be made promptly under any other Federally operated or financed health insurance or benefits program, other than a program operated or financed by the Indian Health Service.
(3) Services are for an unborn child and are payable under Medicaid as a service to an eligible pregnant woman under that program.
(b)
Other regulations applicable to SCHIP programs include the following:
(a) HHS regulations in § 433.50 through § 433.74 of this chapter (sources of non-Federal share and Health Care-Related Taxes and Provider-Related Donations) and § 447.207 of this chapter (Retention of payments) apply to States' SCHIP programs in the same manner as they apply to States' Medicaid programs.
(b) HHS Regulations in 45 CFR subtitle A:
(a)
(1) For fiscal year 1998, a State must submit a budget request in an appropriate format for the 4 quarters of the fiscal year. CMS bases the grant awards for the 4 quarters of fiscal year 1998 based on the State's budget requests for those quarters.
(2) For fiscal years after 1998, a State must submit a budget request in an appropriate format for the first 3 quarters of the fiscal year. CMS bases the grant awards for the first 3 quarters of the fiscal year on the State's budget requests for those quarters.
(3) For fiscal years after 1998, a State must also submit a budget request for the fourth quarter of the fiscal year. The amount of this quarter's grant award is based on the difference between a State's final allotment for the fiscal year, and the total of the grants for the first 3 quarters that were already issued in order to ensure that the total of all grant awards for the fiscal year are equal to the State's final allotment for that fiscal year.
(4) The amount of the quarterly grant is determined on the basis of information submitted by the State (in quarterly estimate and quarterly expenditure reports) and other pertinent information. This information must be submitted by the State through the Medicaid Budget and Expenditure System (MBES) for the Medicaid program, and through the Child Health Budget and Expenditure System (CBES) for the title XXI program.
(b)
(c)
(2) This report is the State's accounting of actual recorded expenditures. This disposition of Federal funds may not be reported on the basis of estimates.
(d)
(1) Name and address of the State Agency/organization administering the program;
(2) The employer identification number (EIN); and
(3) A State official contact name and telephone number.
(e)
(2)
(i) Penalty reductions imposed by law.
(ii) Deferrals or disallowances.
(iii) Interest assessments.
(iv) Mandated adjustments such as those required by Section 1914 of the Act.
(3)
(4)
(f)
(1) Subpart G—Matching and Cost Sharing; and
(2) Subpart I—Financial Report Requirement.
(a)
(1) Sections 2107(a), (b) and (d) of the Act, which set forth requirements for strategic planning, reports, and program budgets; and
(2) Section 2108 of the Act, which sets forth provisions regarding annual reports and evaluation.
(b)
(c)
(a)
(1) The strategic objectives as described in paragraph (b) of this section;
(2) The performance goals as described in paragraph (c) of this section; and
(3) The performance measurements, as described in paragraph (d) of this section, that the State has established for providing child health assistance to targeted low-income children under the plan and otherwise for maximizing health benefits coverage for other low-income children and children generally in the State.
(b)
(c)
(d)
(1) Measured through objective, independently verifiable means; and
(2) Compared against performance goals.
(e)
A State plan must include an assurance that the State collects data, maintains records, and furnishes reports to the Secretary, at the times and in the standardized format the Secretary may require to enable the Secretary to monitor State program administration and compliance and to evaluate and compare the effectiveness of State plans under Title XXI of the Act. This includes collection of data
(a)
(1) Program expenditures;
(2) The number of children enrolled in the title XIX Medicaid program, the separate child health program, and the Medicaid expansion program, as applicable, as of the last day of each quarter of the Federal fiscal year; and
(3) The number of children under 19 years of age who are enrolled in the title XIX Medicaid program, the separate child health program, and in the Medicaid expansion program, as appropriate, by the following categories:
(i) Age (under 1 year of age, 1 through 5 years of age, 6 through 12 years of age, and 13 through 18 years of age).
(ii) Gender, race, and ethnicity.
(iii) Service delivery system (managed care, fee-for-service, and primary care case management).
(iv) Family income as a percentage of the Federal poverty level as described in paragraph (b) of this section.
(b)
(i) At or below 150 percent of FPL.
(ii) Over 150 percent of FPL.
(2) A State that imposes a different level or percentage of cost sharing at different poverty levels must report by poverty level categories that match the poverty level categories used for purposes of cost sharing.
(c)
(a)
(b)
(1) Describe the State's progress in reducing the number of uncovered, low-income children and; in meeting other strategic objectives and performance goals identified in the State plan; and provide information related to a core set of national performance goals and measures as developed by the Secretary;
(2) Report on the effectiveness of the State's policies for discouraging the substitution of public coverage for private coverage;
(3) Identify successes and barriers in State plan design and implementation, and the approaches the State is considering to overcome these barriers;
(4) Describe the State's progress in addressing any specific issues (such as outreach) that the State plan proposed to periodically monitor and assess;
(5) Provide an updated budget for a 3-year period that describes those elements required in § 457.140, including any changes in the sources of the non-Federal share of State plan expenditures;
(6) Identify the total State expenditures for family coverage and total number of children and adults, respectively, covered by family coverage during the preceding Federal fiscal year;
(7) Describe the State's current income standards and methodologies for its Medicaid expansion program, separate child health program, and title XIX Medicaid program, as appropriate.
(c)
(i) A State may base the estimate on data from—
(A) The March supplement to the Current Population Survey (CPS);
(B) A State-specific survey;
(C) A statistically adjusted CPS; or
(D) Another appropriate source.
(ii) If the State does not base the estimate on data from the March supplement to the CPS, the State must submit a description of the methodology used to develop the initial baseline estimate and the rationale for its use.
(2) The State must provide an annual estimate of changes in the number of uninsured in the State using—
(i) The same methodology used in establishing the initial baseline; or
(ii) Another methodology based on new information that enables the State to establish a new baseline.
(3) If a new methodology is used, the State must also provide annual estimates based on either the March supplement to the CPS or the methodology used to develop the initial baseline.
(a)
(b)
(c)
The State plan must include a description of reasonable procedures to ensure that health benefits coverage provided under the State plan does not substitute for coverage provided under group health plans as defined at § 457.10.
A State that operates a premium assistance program, as defined at § 457.10, must provide the protections against substitution of SCHIP coverage for coverage under group health plans specified in this section. The State must describe these protections in the State plan; and report on results of monitoring of substitution in its annual reports.
(a)
(1) An enrollee must not have had coverage under a group health plan for a period of at least 6 months prior to enrollment in a premium assistance program. A State may not require a minimum period without coverage under a group health plan that exceeds 12 months.
(2) States may permit reasonable exceptions to the requirement for a minimum period without coverage under a group health plan for—
(i) Involuntary loss of coverage under a group health plan, due to employer termination of coverage for all employees and dependents;
(ii) Economic hardship;
(iii) Change to employment that does not offer dependent coverage; or
(iv) Other reasons proposed by the State and approved as part of the State plan.
(3) The requirement for a minimum period without coverage under a group health plan does not apply to a child who, within the previous 6 months, has received coverage under a group health plan through Medicaid under section 1906 of the Act.
(4) The Secretary may waive the 6-month waiting period requirement described in this section at her discretion.
(b)
(c)
(1) The State's cost for coverage for children under premium assistance programs must not be greater than the cost of other SCHIP coverage for these children; and
(2) The State may base its demonstration of cost effectiveness on an assessment of the cost of coverage for children under premium assistance programs to the cost of other SCHIP coverage for these children, done on a case-by-case basis, or on the cost of premium assisted coverage in the aggregate.
(d)
(a)
(1) Section 2101(a) of the Act, which provides that the purpose of title XXI is to provide funds to States to enable them to initiate and expand the provision of child health assistance to uninsured, low-income children in an effective and efficient manner; and
(2) Section 2107(e) of the Act, which provides that certain title XIX and title XI provisions, including the following, apply to States under title XXI in the same manner as they apply to a State under title XIX:
(i) Section 1902(a)(4)(C) of the Act, relating to conflict of interest standards.
(ii) Paragraphs (2), (16), and (17), of section 1903(i) of the Act, relating to limitations on payment.
(iii) Section 1903(w) of the Act, relating to limitations on provider taxes and donations.
(iv) Section 1124 of the Act, relating to disclosure of ownership and related information.
(v) Section 1126 of the Act, relating to disclosure of information about certain convicted individuals.
(vi) Section 1128 of the Act, relating to exclusions.
(vii) Section 1128A of the Act, relating to civil monetary penalties.
(viii) Section 1128B(d) of the Act, relating to criminal penalties for certain additional charges.
(ix) Section 1132 of the Act, relating to periods within which claims must be filed.
(b)
(c)
As used in this subpart—
The State's child health program must include—
(a) Methods of administration that the Secretary finds necessary for the proper and efficient operation of the separate child health program; and
(b) Safeguards necessary to ensure that—
(1) Eligibility will be determined appropriately in accordance with subpart C of this part; and
(2) Services will be provided in a manner consistent with administrative simplification and with the provisions of subpart D of this part.
(a)
(1) Methods and criteria for identifying suspected fraud and abuse cases.
(2) Methods for investigating fraud and abuse cases that—
(i) Do not infringe on legal rights of persons involved; and
(ii) Afford due process of law.
(b)
(c)
(1) U.S. Department of Health and Human Services Office of Inspector General (OIG);
(2) U.S. Attorney's Office, Department of Justice (DOJ);
(3) Federal Bureau of Investigation (FBI); and
(4) State Attorney General's office.
If the State agency receives a complaint of fraud or abuse from any source or identifies questionable practices, the State agency must conduct a preliminary investigation or take otherwise appropriate action within a reasonable period of time to determine whether there is sufficient basis to warrant a full investigation.
The State must establish and implement effective procedures for investigating and resolving suspected and apparent instances of fraud and abuse. Once the State determines that a full investigation is warranted, the State must implement procedures including, but not limited to the following:
(a) Cooperate with and refer potential fraud and abuse cases to the State program integrity unit, if such a unit exists.
(b) Conduct a full investigation.
(c) Refer the fraud and abuse case to appropriate law enforcement officials.
(a) A State may not make payments for any item or service furnished, ordered, or prescribed under a separate child health program to any provider who has been excluded from participating in the Medicare and Medicaid programs.
(b) The following provisions and their corresponding regulations apply to a State under title XXI, in the same manner as these provisions and regulations apply to a State under title XIX:
(1) Part 455, subpart B of this chapter.
(2) Section 1124 of the Act pertaining to disclosure of ownership and related information.
(3) Section 1126 of the Act pertaining to disclosure by institutions, organizations, and agencies of owners and certain other individuals who have been convicted of certain offenses.
(4) Section 1128 of the Act pertaining to exclusions.
(5) Section 1128A of the Act pertaining to civil monetary penalties.
(6) Section 1128B of the Act pertaining to criminal penalties for acts involving Federal health care programs.
(7) Section 1128E of the Act pertaining to the reporting of final adverse actions on liability findings made
(a) A State must submit to CMS a written assurance that title XXI services will be provided in an effective and efficient manner. The State must submit the assurance—
(1) With the initial State plan; or
(2) For States with approved plans, with the first request to amend the approved plan.
(b) A State must—
(1) Provide for free and open competition, to the maximum extent practical, in the bidding of all procurement contracts for coverage or other services in accordance with the procurement requirements of 45 CFR 74.43 or 45 CFR 92.36, as applicable; or
(2) Use payment rates based on public or private payment rates for comparable services for comparable populations, consistent with principles of actuarial soundness as defined at § 457.902.
(c) A State may establish higher rates than permitted under paragraph (b) of this section if such rates are necessary to ensure sufficient provider participation, provider access, or to enroll providers who demonstrate exceptional efficiency or quality in the provision of services.
(d) All contracts under this part must include provisions that define a sound and complete procurement contract, as required by 45 CFR part 74 or 45 CFR part 92, as applicable.
(e) The State must provide to CMS, if requested, a description of the manner in which rates were developed in accordance with the requirements of paragraphs (b) or (c) of this section.
Entities that contract with the State under a separate child health program must certify the accuracy, completeness, and truthfulness of information in contracts and proposals, including information on subcontractors, and other related documents, as specified by the State.
(a)
(1) Enrollment information and other information required by the State;
(2) An attestation to the accuracy, completeness, and truthfulness of claims and payment data, under penalty of perjury;
(3) Access for the State, CMS, and the HHS Office of the Inspector General to enrollee health claims data and payment data, in conformance with the appropriate privacy protections in the State; and
(4) A guarantee that the MCE will not avoid costs for services covered in its contract by referring enrollees to publicly supported health care resources.
(b)
(1) Establish procedures to ensure that the entity certifies and attests that information on claim forms is truthful, accurate, and complete;
(2) Ensure that fee-for-service entities understand that payment and satisfaction of the claims will be from Federal and State funds, and that any false claims may be prosecuted under applicable Federal or State laws; and
(3) Require, as a condition of participation, that fee-for-service entities provide the State, CMS and/or the HHS Office of the Inspector General with access to enrollee health claims data, claims payment data and related records.
(a) The State must assure that any entity seeking to contract as an MCE under a separate child health program has administrative and management
(b) The State must ensure that the arrangements or procedures required in paragraph (a) of this section—
(1) Enforce MCE compliance with all applicable Federal and State standards;
(2) Prohibit MCEs from conducting any unsolicited personal contact with a potential enrollee by an employee or agent of a managed care entity for the purpose of influencing the individual to enroll with the entity; and
(3) Include a mechanism for the MCE to report to the State, to CMS, or to the Office of Inspector General (OIG) as appropriate, information on violations of law by subcontractors or enrollees of an MCE and other individuals.
(c) With respect to enrollees, the reporting requirement in paragraph (b)(3) of this section applies only to information on violations of law that pertain to enrollment in the plan, or the provision of, or payment for, health services.
(d) The State may inspect, evaluate, and audit MCEs at any time, as necessary, in instances where the State determines that there is a reasonable possibility of fraudulent and abusive activity.
If the State requires reporting of changes in circumstances that may affect the enrollee's eligibility for child health assistance, the State must:
(a) Establish procedures to ensure that enrollees make timely and accurate reports of any such change; and
(b) Promptly redetermine eligibility when the State has information about these changes.
The State must include in each applicant's record facts to support the State's determination of the applicant's eligibility for SCHIP.
The State must establish and maintain systems to identify, report, and verify the accuracy of claims for those enrolled children who meet requirements of section 2105(a) of the Act, where enhanced Federal medical assistance percentage computations apply.
The State must ensure through its contracts for coverage and services that its contractors comply with—
(a) Section 422.206(a) of this chapter, which prohibits interference with health care professionals' advice to enrollees and requires that professionals provide information about treatment in an appropriate manner; and
(b) Sections 422.208 and 422.210 of this chapter, which place limitations on physician incentive plans, and information disclosure requirements related to those physician incentive plans, respectively.
(a)
(1) Section 2105(c)(2)(B) of the Act, which sets forth the requirements to permit a State to exceed the 10 percent cost limit on expenditures other than benefit expenditures; and
(2) Section 2105(c)(3) of the Act, which permits the purchase of family coverage.
(b)
(c)
CMS will review the waiver requests under this subpart using the same time frames used for State plan amendments, as specified in § 457.160.
(a)
(b)
(1) The coverage meets all of the requirements of this part, including subpart D and subpart E.
(2) The cost of such coverage, on an average per child basis, does not exceed the cost of coverage under the State plan.
(c)
(d)
(1) Other child health assistance, health services initiatives, or outreach; or
(2) Any reasonable costs necessary to administer the State's program.
A State may purchase family coverage that includes coverage for targeted low-income children if the State establishes that—
(a) Purchase of family coverage is cost-effective under the standards described in § 457.1015;
(b) The State does not purchase the coverage if it would otherwise substitute for health insurance coverage that would be provided to targeted, low-income children but for the purchase of family coverage; and
(c) The coverage for the family otherwise meets the requirements of this part.
(a)
(b)
(c)
(2) The State must assess cost-effectiveness in its initial request for a waiver and then annually.
(3) For any State that chooses the aggregate cost method, if an annual assessment of the cost-effectiveness of family coverage in the aggregate reveals that it is not cost-effective, the State must assess cost-effectiveness on a case-by-case basis.
(d)
(a)
(1) Section 2101(a) of the Act, which states that the purpose of title XXI of the Act is to provide funds to States to enable them to initiate and expand the provision of child health assistance to uninsured, low-income children in an effective and efficient manner;
(2) Section 2102(a)(7)(B) of the Act, which requires that the State plan include a description of the methods used to assure access to covered services, including emergency services;
(3) Section 2102(b)(2) of the Act, which requires that the State plan include a description of methods of establishing and continuing eligibility and enrollment; and
(4) Section 2103 of the Act, which outlines coverage requirements for a State that provides child health assistance through a separate child health program.
(b)
(c)
The State must ensure that, for individual medical records and any other health and enrollment information maintained with respect to enrollees, that identifies particular enrollees (in any form), the State establishes and implements procedures to—
(a) Abide by all applicable Federal and State laws regarding confidentiality and disclosure, including those laws addressing the confidentiality of information about minors and the privacy of minors, and privacy of individually identifiable health information;
(b) Comply with subpart F of part 431 of this chapter;
(c) Maintain the records and information in a timely and accurate manner;
(d) Specify and make available to any enrollee requesting it—
(1) The purposes for which information is maintained or used; and
(2) To whom and for what purposes the information will be disclosed outside the State;
(e) Except as provided by Federal and State law, ensure that each enrollee may request and receive a copy of records and information pertaining to the enrollee in a timely manner and that an enrollee may request that such records or information be supplemented or corrected.
(a) The State must have one of the following review processes:
(1)
(2)
(b) The State plan must include a description of the State's review process.
(a)
(1) Denial of eligibility;
(2) Failure to make a timely determination of eligibility; and
(3) Suspension or termination of enrollment, including disenrollment for failure to pay cost sharing.
(b)
(1) Delay, denial, reduction, suspension, or termination of health services,
(2) Failure to approve, furnish, or provide payment for health services in a timely manner.
(c)
In adopting the procedures for review of matters described in § 457.1130, a State must ensure that—
(a) Reviews are conducted by an impartial person or entity in accordance with § 457.1150;
(b) Review decisions are timely in accordance with § 457.1160;
(c) Review decisions are written; and
(d) Applicants and enrollees have an opportunity to—
(1) Represent themselves or have representatives of their choosing in the review process;
(2) Timely review their files and other applicable information relevant to the review of the decision;
(3) Fully participate in the review process, whether the review is conducted in person or in writing, including by presenting supplemental information during the review process; and
(4) Receive continued enrollment in accordance with § 457.1170.
(a)
(b)
(a)
(b)
(1)
(2)
A State must ensure the opportunity for continuation of enrollment pending
A State must provide enrollees and applicants timely written notice of any determinations required to be subject to review under § 457.1130 that includes the reasons for the determination, an explanation of applicable rights to review of that determination, the standard and expedited time frames for review, the manner in which a review can be requested, and the circumstances under which enrollment may continue pending review.
A State that has a premium assistance program through which it provides coverage under a group health plan that does not meet the requirements of a program specific review or a Statewide standard review, as described in § 457.1120, must give applicants and enrollees the option to obtain health benefits coverage other than through that group health plan. The State must provide this option at initial enrollment and at each redetermination of eligibility.
Secs. 1102, 1871, 1894(f), and 1934(f) of the Social Security Act (42 U.S.C. 1302, 1395, 1395eee(f), and 1396u-4(f)).
Nomenclature changes to part 460 appear at 67 FR 61504, Oct. 1, 2002.
This part implements sections 1894, 1905(a), and 1934 of the Act, which authorize the following:
(a) Medicare payments to, and coverage of benefits under, PACE.
(b) The establishment of PACE as a State option under Medicaid to provide for Medicaid payments to, and coverage of benefits under, PACE.
(a)
(1) The requirements that an entity must meet to be approved as a PACE organization that operates a PACE program under Medicare and Medicaid.
(2) How individuals may qualify to enroll in a PACE program.
(3) How Medicare and Medicaid payments will be made for PACE services.
(4) Provisions for Federal and State monitoring of PACE programs.
(5) Procedures for sanctions and terminations.
(b)
(1) Enhance the quality of life and autonomy for frail, older adults.
(2) Maximize dignity of, and respect for, older adults.
(3) Enable frail, older adults to live in the community as long as medically and socially feasible.
(4) Preserve and support the older adult's family unit.
As used in this part, unless the context indicates otherwise, the following definitions apply:
This subpart sets forth the application requirements for an entity that seeks approval from CMS as a PACE organization and the process by which a PACE organization may request waiver of certain regulatory requirements. The purpose of the waivers is to provide for reasonable flexibility in adapting the PACE model to the needs of particular organizations (such as those in rural areas).
(a)
(2) CMS accepts applications from entities that seek approval as PACE organizations beginning on February 22, 2000 except for the following:
(i) Beginning on November 24, 1999, CMS accepts applications from entities that meet the requirements for priority consideration in processing of applications.
(ii) Beginning on January 10, 2000, CMS accepts applications from entities that meet the requirements for special consideration in processing applications.
(b)
(1) Considers the entity to be qualified to be a PACE organization; and
(2) Is willing to enter into a PACE program agreement with the entity.
CMS evaluates an application for approval as a PACE organization on the basis of the following information:
(a) Information contained in the application.
(b) Information obtained through onsite visits conducted by CMS or the State administering agency.
(c) Information obtained by the State administering agency.
(a)
(1) Approves the application.
(2) Denies the application and notifies the entity in writing of the basis for the denial and the process for requesting reconsideration of the denial.
(3) Requests additional information needed to make a final determination.
(b)
(1) Approves the application.
(2) Denies the application and notifies the entity in writing of the basis
(c)
(1) The date the application is submitted by the organization.
(2) The date CMS receives all requested additional information.
(d)
(a) An entity must state in its application the service area it proposes for its program.
(b) CMS, in consultation with the State administering agency, may exclude from designation an area that is already covered under another PACE program agreement to avoid unnecessary duplication of services and avoid impairing the financial and service viability of an existing program.
(a)
(1) As of August 5, 1997—40.
(2) As of each succeeding August 5, the numerical limit for the preceding year plus 20, without regard to the actual number of agreements in effect on a previous anniversary date. (For example, the limit is 60 on August 5, 1998 and 80 on August 5, 1999.)
(b)
(1) Is operating under a demonstration project waiver under section 1894(h) and 1934(h) of the Act.
(2) Was operating under a waiver and subsequently qualifies for PACE organization status in accordance with sections 1894(a)(3)(B)(ii) and 1934(a)(3)(B)(ii) of the Act.
(a)(1) A PACE organization must submit its waiver request through the State administering agency for initial review. The State administering agency forwards waiver requests to CMS along with any concerns or conditions regarding the waiver.
(2) Entities submitting an application to become a PACE organization may submit a waiver request. The entity must submit its waiver request through the State administering agency for initial review. The State administering agency forwards the waiver requests to CMS along with any concerns or conditions regarding the waiver. The waiver request is submitted as a document separate from the application but may be submitted in conjunction with and at the same time as the application.
(b) CMS evaluates a waiver request from a PACE organization on the basis of the following information:
(1) The adequacy of the description and rationale for the waiver provided by the PACE organization or PACE applicant, including any additional information requested by CMS.
(2) Information obtained by CMS and the State administering agency in on-site reviews and monitoring of the PACE organization.
(c) Requirements related to the following principles may not be waived:
(1) A focus on frail elderly qualifying individuals who require the level of care provided in a nursing facility.
(2) The delivery of comprehensive, integrated acute and long-term care services.
(3) An interdisciplinary team approach to care management and service delivery.
(4) Capitated, integrated financing that allows the provider to pool payments received from public and private programs and individuals.
(5) The assumption by the provider of full financial risk.
(a)
(1) Approves the request.
(2) Denies the request and notifies the PACE organization or PACE applicant in writing of the basis of the denial.
(b)
(c)
(2) CMS may withdraw approval of a waiver for good cause.
(a) A PACE organization must have an agreement with CMS and the State administering agency for the operation of a PACE program by the PACE organization under Medicare and Medicaid.
(b) The agreement must be signed by an authorized official of CMS, the PACE organization and the State administering agency.
(c) CMS may only sign program agreements with PACE organizations that are located in States with approved State plan amendments electing PACE as an optional benefit under their Medicaid State plan.
(a)
(1) A designation of the service area of the organization's program. The area may be identified by county, zip code, street boundaries, census tract, block, or tribal jurisdictional area, as applicable. CMS and the State administering agency must approve any change in the designated service area.
(2) The organization's commitment to meet all applicable requirements under Federal, State, and local laws and regulations, including provisions of the Civil Rights Act, the Age Discrimination Act, and the Americans With Disabilities Act.
(3) The effective date and term of the agreement.
(4) A description of the organizational structure of the PACE organization and information on administrative contacts, including the following:
(i) Name and phone number of the program director.
(ii) Name of all governing body members.
(iii) Name and phone number of a contact person for the governing body.
(5) A participant bill of rights approved by CMS and an assurance that the rights and protections will be provided.
(6) A description of the process for handling participant grievances and appeals.
(7) A statement of the organization's policies on eligibility, enrollment, voluntary disenrollment, and involuntary disenrollment.
(8) A description of services available to participants.
(9) A description of the organization's quality assessment and performance improvement program.
(10) A statement of the levels of performance required by CMS on standard quality measures.
(11) A statement of the data and information required by CMS and the State administering agency to be collected on participant care.
(12) The Medicaid capitation rate and the methodology used to calculate the Medicare capitation rate.
(13) A description of procedures that the organization will follow if the PACE program agreement is terminated.
(b)
(2) An agreement may contain any additional terms and conditions agreed to by the parties if the terms and conditions are consistent with sections 1894 and 1934 of the Act and regulations in this part.
An agreement is effective for a contract year, but may be extended for additional contract years in the absence of a notice by a party to terminate.
In addition to other remedies authorized by law, CMS may impose any of the sanctions specified in §§ 460.42 and 460.46 if CMS determines that a PACE organization commits any of the following violations:
(a) Fails substantially to provide to a participant medically necessary items and services that are covered PACE services, if the failure has adversely affected (or has substantial likelihood of adversely affecting) the participant.
(b) Involuntarily disenrolls a participant in violation of § 460.164.
(c) Discriminates in enrollment or disenrollment among Medicare beneficiaries or Medicaid recipients, or both, who are eligible to enroll in a PACE program, on the basis of an individual's health status or need for health care services.
(d) Engages in any practice that would reasonably be expected to have the effect of denying or discouraging enrollment, except as permitted by § 460.150, by Medicare beneficiaries or Medicaid recipients whose medical condition or history indicates a need for substantial future medical services.
(e) Imposes charges on participants enrolled under Medicare or Medicaid for premiums in excess of the premiums permitted.
(f) Misrepresents or falsifies information that is furnished—
(1) To CMS or the State under this part; or
(2) To an individual or any other entity under this part.
(g) Prohibits or otherwise restricts a covered health care professional from advising a participant who is a patient of the professional about the participant's health status, medical care, or treatment for the participant's condition or disease, regardless of whether the PACE program provides benefits for that care or treatment, if the professional is acting within his or her lawful scope of practice.
(h) Operates a physician incentive plan that does not meet the requirements of section 1876(i)(8) of the Act.
(i) Employs or contracts with any individual who is excluded from participation in Medicare or Medicaid under section 1128 or section 1128A of the Act (or with any entity that employs or contracts with that individual) for the provision of health care, utilization review, medical social work, or administrative services.
(a)
(b)
(1) Suspend Medicare payment to the PACE organization.
(2) Deny payment to the State for medical assistance for services furnished under the PACE program agreement.
(c)
(1) The PACE organization has corrected the cause of the violation.
(2) The violation is not likely to recur.
(a) CMS may impose civil money penalties up to the following maximum amounts:
(1) For each violation regarding enrollment or disenrollment specified in § 460.40 (c) or (d), $100,000 plus $15,000 for each individual not enrolled as a result of the PACE organization's discrimination in enrollment or disenrollment or practice that would deny or discourage enrollment.
(2) For each violation regarding excessive premiums specified in § 460.40(e), $25,000 plus double the excess amount above the permitted premium charged a participant by the PACE organization. (The excess amount charged is deducted from the penalty and returned to the participant).
(3) For each misrepresentation or falsification of information, specified in § 460.40(f)(1), $100,000.
(4) For any other violation specified in § 460.40, $25,000.
(b) The provisions of section 1128A of the Act (other than subsections (a) and (b)) apply to a civil money penalty under this section in the same manner as they apply to a civil money penalty or proceeding under section 1128A(a).
After consultation with the State administering agency, if CMS determines that the PACE organization is not in substantial compliance with requirements in this part, CMS or the State administering agency may take one or more of the following actions:
(a) Condition the continuation of the PACE program agreement upon timely execution of a corrective action plan.
(b) Withhold some or all payments under the PACE program agreement until the organization corrects the deficiency.
(c) Terminate the PACE program agreement.
(a)
(b)
(1) Either—
(i) There are significant deficiencies in the quality of care furnished to participants; or
(ii) The PACE organization failed to comply substantially with conditions for a PACE program or PACE organization under this part, or with terms of its PACE program agreement.
(2) Within 30 days of the date of the receipt of written notice of a determination made under paragraph (b)(1) of this section, the PACE organization failed to develop and successfully initiate a plan to correct the deficiencies, or failed to continue implementation of the plan of correction.
(c)
(d)
(1) To CMS and the State administering agency, 90 days before termination.
(2) To participants, 60 days before termination.
(a) The PACE organization must develop a detailed written plan for phase-down in the event of termination, which describes how the organization plans to take the following actions:
(1) Inform participants, the community, CMS and the State administering
(2) Assist participants to obtain reinstatement of conventional Medicare and Medicaid benefits.
(3) Transition participants' care to other providers.
(4) Terminate marketing and enrollment activities.
(b) An entity whose PACE program agreement is in the process of being terminated must provide assistance to each participant in obtaining necessary transitional care through appropriate referrals and making the participant's medical records available to new providers.
(a) Except as provided in paragraph (b) of this section, if CMS terminates an agreement with a PACE organization, it furnishes the PACE organization with the following:
(1) A reasonable opportunity to develop and implement a corrective action plan to correct the deficiencies that were the basis of CMS's determination that cause exists for termination.
(2) Reasonable notice and opportunity for hearing (including the right to appeal an initial determination) before terminating the agreement.
(b) CMS may terminate an agreement without invoking the procedures described in paragraph (a) of this section if CMS determines that a delay in termination, resulting from compliance with these procedures before termination, would pose an imminent and serious risk to the health of participants enrolled with the organization.
(a) A PACE organization must be, or be a distinct part of, one of the following:
(1) An entity of city, county, State, or Tribal government.
(2) A private not-for-profit entity organized for charitable purposes under section 501(c)(3) of the Internal Revenue Code of 1986. The entity may be a corporation, a subsidiary of a larger corporation, or a department of a corporation.
(b)
(c)
(d)
(2) The chart for a corporate entity must indicate the PACE organization's relationship to the corporate board and to any parent, affiliate, or subsidiary corporate entities.
(3) A PACE organization planning a change in organizational structure must notify CMS and the State administering agency, in writing, at least 14 days before the change takes effect.
(a)
(1) Governance and operation of the organization.
(2) Development of policies consistent with the mission.
(3) Management and provision of all services, including the management of contractors.
(4) Establishment of personnel policies that address adequate notice of termination by employees or contractors with direct patient care responsibilities.
(5) Fiscal operations.
(6) Development of policies on participant health and safety, including a
(7) Quality assessment and performance improvement program.
(b)
(2) The participant advisory committee must provide the liaison to the governing body with meeting minutes that include participant issues.
(c)
(2) The participant representative is a liaison of the participant advisory committee to the PACE organization governing body.
(3)
(a)
(1) Be legally authorized (for example, currently licensed, registered or certified if applicable) to practice in the State in which he or she performs the function or action;
(2) Only act within the scope of his or her authority to practice;
(3) Have 1 year of experience with a frail or elderly population;
(4) Meet a standardized set of competencies for the specific position description established by the PACE organization and approved by CMS before working independently.
(5) Be medically cleared for communicable diseases and have all immunizations up-to-date before engaging in direct participant contact.
(b)
(a) The PACE organization must provide training to maintain and improve the skills and knowledge of each staff member with respect to the individual's specific duties that results in his or her continued ability to demonstrate the skills necessary for the performance of the position.
(b) The PACE organization must develop a training program for each personal care attendant to establish the individual's competency in furnishing personal care services and specialized skills associated with specific care needs of individual participants.
(c) Personal care attendants must exhibit competency before performing personal care services independently.
(a)
(1) Who have been excluded from participation in the Medicare or Medicaid programs;
(2) Who have been convicted of criminal offenses related to their involvement in Medicaid, Medicare, other health insurance or health care programs, or social service programs under title XX of the Act; or
(3) In any capacity where an individual's contact with participants would pose a potential risk because the individual has been convicted of physical, sexual, drug, or alcohol abuse.
(b)
(1) PACE organizations must develop policies and procedures for handling any direct or indirect conflict of interest by a member of the governing body or by the member's immediate family.
(2) In the event of a direct or indirect conflict of interest by a member of the PACE organization's governing body or his or her immediate family member, the board member must—
(i) Fully disclose the exact nature of the conflict to the board of directors and have the disclosure documented; and
(ii) Recuse himself or herself from discussing, negotiating, or voting on any issue or contract that could result in an inappropriate conflict.
(c)
(a)
(b)
(1) The PACE organization must contract only with an entity that meets all applicable Federal and State requirements, including, but not limited to, the following:
(i) An institutional contractor, such as a hospital or skilled nursing facility, must meet Medicare or Medicaid participation requirements.
(ii) A practitioner or supplier must meet Medicare or Medicaid requirements applicable to the services it furnishes.
(iii) A contractor must comply with the requirements of this part with respect to service delivery, participant rights, and quality assessment and performance improvement activities.
(2) A contractor must be accessible to participants, located either within or near the PACE organization's service area.
(3) A PACE organization must designate an official liaison to coordinate activities between contractors and the organization.
(c)
(d)
(1) Name of contractor.
(2) Services furnished (including work schedule if appropriate).
(3) Payment rate and method.
(4) Terms of the contract, including beginning and ending dates, methods of extension, renegotiation, and termination.
(5) Contractor agreement to do the following:
(i) Furnish only those services authorized by the PACE interdisciplinary team.
(ii) Accept payment from the PACE organization as payment in full, and not bill participants, CMS, the State administering agency, or private insurers.
(iii) Hold harmless CMS, the State, and PACE participants if the PACE organization does not pay for services performed by the contractor in accordance with the contract.
(iv) Not assign the contract or delegate duties under the contract unless it obtains prior written approval from the PACE organization.
(v) Submit reports required by the PACE organization.
(vi) Agree to perform all the duties related to its position as specified in this part.
(vii) Participate in interdisciplinary team meeting as required.
(viii) Agree to be accountable to the PACE organization.
(ix) Cooperate with the competency evaluation program and direct participant care requirements specified in § 460.71.
(e)
(2) The PACE organization retains responsibility for all participants and may only contract for the PACE Center services identified in § 460.98(d).
(a) The PACE organization must ensure that all employees and contracted staff furnishing care directly to participants demonstrate the skills necessary for performance of their position.
(1) The PACE organization must provide each employee and all contracted staff with an orientation. The orientation must include at a minimum the organization's mission, philosophy, policies on participant rights, emergency plan, ethics, the PACE benefit, and any policies related to the job duties of specific staff.
(2) The PACE organization must develop a competency evaluation program that identifies those skills, knowledge, and abilities that must be demonstrated by direct participant care staff (employees and contractors).
(3) The competency program must be evidenced as completed before performing participant care and on an ongoing basis by qualified professionals.
(4) The PACE organization must designate a staff member to oversee these activities for employees and work with the PACE contractor liaison to ensure compliance by contracted staff.
(b) The PACE organization must develop a program to ensure that all staff furnishing direct participant care services meet the following requirements:
(1) Comply with any State or Federal requirements for direct patient care staff in their respective settings.
(2) Comply with the requirements of § 460.68(a) regarding persons with criminal convictions.
(3) Have verified current certifications or licenses for their respective positions.
(4) Are free of communicable diseases and are up to date with immunizations before performing direct patient care.
(5) Have been oriented to the PACE program.
(6) Agree to abide by the philosophy, practices, and protocols of the PACE organization.
(a)
(i) Be designed, constructed, equipped, and maintained to provide for the physical safety of participants, personnel, and visitors.
(ii) Ensure a safe, sanitary, functional, accessible, and comfortable environment for the delivery of services that protects the dignity and privacy of the participant.
(2)
(3)
(ii) A PACE organization must perform the manufacturer's recommended maintenance on all equipment as indicated in the organization's written plan.
(b)
(i) A PACE center must meet the applicable provisions of the 2000 edition of the Life Safety Code (LSC) of the National Fire Protection Association
(ii) Chapter 19.3.6.3.2, exception number 2 of the adopted edition of the LSC does not apply to PACE centers.
(2)
(ii) CMS may waive specific provisions of the Life Safety Code that, if rigidly applied, would result in unreasonable hardship on the Pace center, but only if the waiver does not adversely affect the health and safety of the participants and staff.
(3) Beginning March 13, 2006, a PACE center must be in compliance with Chapter 9.2.9, Emergency Lighting.
(4) Beginning March 13, 2006, Chapter 19.3.6.3.2, exception number 2 does not apply to PACE centers.
(5) Notwithstanding any provisions of the 2000 edition of the Life Safety Code to the contrary, a PACE center may install alcohol-based hand rub dispensers in its facility if—
(i) Use of alcohol-based hand rub dispensers does not conflict with any State or local codes that prohibit or otherwise restrict the placement of alcohol-based hand rub dispensers in health care facilities;
(ii) The dispensers are installed in a manner that minimizes leaks and spills that could lead to falls;
(iii) The dispensers are installed in a manner that adequately protects against inappropriate access;
(iv) The dispensers are installed in accordance with chapter 18.3.2.7 or chapter 19.3.2.7 of the 2000 edition of the Life Safety Code, as amended by NFPA Temporary Interim Amendment 00-1(101), issued by the Standards Council of the National Fire Protection Association on April 15, 2004. The Director of the Office of the Federal Register has approved NFPA Temporary Interim Amendment 00-1(101) for incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy of the amendment is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD and at the Office of the Federal Register, 800 North Capitol Street NW., Suite 700, Washington, DC. Copies may be obtained from the National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269; and
(v) The dispensers are maintained in accordance with dispenser manufacturer guidelines.
(c)
(2)
(i) Fire.
(ii) Equipment, water, or power failure.
(iii) Care-related emergencies.
(iv) Natural disasters likely to occur in the organization's geographic area. (An organization is not required to develop emergency plans for natural disasters that typically do not affect its geographic location.)
(3)
(4)
(5)
(a)
(b)
(1) Ensures a safe and sanitary environment.
(2) Prevents and controls the transmission of disease and infection.
(c)
(1) Procedures to identify, investigate, control, and prevent infections in every Pace center and in each participant's place of residence.
(2) Procedures to record any incidents of infection.
(3) Procedures to analyze the incidents of infection to identify trends and develop corrective actions related to the reduction of future incidents.
(a)
(b)
(2) If a contractor provides transportation services, the PACE organization must ensure that the vehicles are maintained in accordance with the manufacturer's recommendations.
(c)
(d)
(1) Managing the special needs of participants.
(2) Handling emergency situations.
(e)
(a)
(i) Be prepared by methods that conserve nutritive value, flavor, and appearance.
(ii) Be prepared in a form designed to meet individual needs.
(iii) Be prepared and served at the proper temperature.
(2) The PACE organization must provide substitute foods or nutritional
(i) Refuses the food served.
(ii) Cannot tolerate the food served.
(iii) Does not eat adequately.
(3) The PACE organization must provide nutrition support to meet the daily nutritional needs of a participant, if indicated by his or her medical condition or diagnosis. Nutrition support consists of tube feedings, total parenteral nutrition, or peripheral parenteral nutrition.
(b)
(1) Procure foods (including nutritional supplements and nutrition support items) from sources approved, or considered satisfactory, by Federal, State, Tribal, or local authorities with jurisdiction over the service area of the organization.
(2) Store, prepare, distribute, and serve foods (including nutritional supplements and nutrition support items) under sanitary conditions.
(3) Dispose of garbage and refuse properly.
(a)
(1) Total assets greater than total unsubordinated liabilities.
(2) Sufficient cash flow and adequate liquidity to meet obligations as they become due.
(3) A net operating surplus or a financial plan for maintaining solvency that is satisfactory to CMS and the State administering agency.
(b)
(1) Continuation of benefits for the duration of the period for which capitation payment has been made.
(2) Continuation of benefits to participants who are confined in a hospital on the date of insolvency until their discharge.
(3) Protection of participants from liability for payment of fees that are the legal obligation of the PACE organization.
(c)
(i) One month's total capitation revenue to cover expenses the month before insolvency.
(ii) One month's average payment to all contractors, based on the prior quarter's average payment, to cover expenses the month after the date it declares insolvency or ceases operations.
(2) Arrangements to cover expenses may include, but are not limited to, the following:
(i) Insolvency insurance or reinsurance.
(ii) Hold harmless arrangement.
(iii) Letters of credit, guarantees, net worth, restricted State reserves, or State law provisions.
(a)
(i) An adequate description of the PACE organization's enrollment and disenrollment policies and requirements.
(ii) PACE enrollment procedures.
(iii) Description of benefits and services.
(iv) Premiums.
(v) Other information necessary for prospective participants to make an informed decision about enrollment.
(2) Marketing information must be free of material inaccuracies, misleading information, or misrepresentations.
(b)
(2) CMS reviews initial marketing information as part of an entity's application for approval as a PACE organization, and approval of the application includes approval of marketing information.
(3) Once a PACE organization is under a PACE program agreement, any revisions to existing marketing information and new information are subject to the following:
(i)
(ii)
(c)
(1) In English and in any other principal languages of the community.
(2) In Braille, if necessary.
(d)
(2) All marketing materials must state clearly that PACE participants may be fully and personally liable for the costs of unauthorized or out-of-PACE program agreement services.
(e)
(1) Discrimination of any kind, except that marketing may be directed to individuals eligible for PACE by reason of their age.
(2) Activities that could mislead or confuse potential participants, or misrepresent the PACE organization, CMS, or the State administering agency.
(3) Gifts or payments to induce enrollment.
(4) Contracting outreach efforts to individuals or organizations whose sole responsibility involves direct contact with the elderly to solicit enrollment.
(5) Unsolicited door-to-door marketing.
(f)
If a Medicare beneficiary or Medicaid recipient chooses to enroll in a PACE program, the following conditions apply:
(a) Medicare and Medicaid benefit limitations and conditions relating to amount, duration, scope of services, deductibles, copayments, coinsurance, or other cost-sharing do not apply.
(b) The participant, while enrolled in a PACE program, must receive Medicare and Medicaid benefits solely through the PACE organization.
The PACE benefit package for all participants, regardless of the source of payment, must include the following:
(a) All Medicare-covered items and services.
(b) All Medicaid-covered items and services, as specified in the State's approved Medicaid plan.
(c) Other services determined necessary by the interdisciplinary team to improve and maintain the participant's overall health status.
(a) Except for Medicare requirements that are waived for the PACE program, as specified in paragraph (b) of this section, the PACE benefit package for Medicare participants must include the following services:
(1) The scope of hospital insurance benefits described in part 409 of this chapter.
(2) The scope of supplemental medical insurance benefits described in part 410 of this chapter.
(b)
(1) The provisions of subpart F of part 409 of this chapter that limit coverage of institutional services.
(2) The provisions of subparts G and H of part 409 of this chapter, and parts 412 through 414 of this chapter that relate to payment for benefits.
(3) The provisions of subparts D and E of part 409 of this chapter that limit coverage of extended care services or home health services.
(4) The provisions of subpart D of part 409 of this chapter that impose a 3-day prior hospitalization requirement for coverage of extended care services.
(5) Section 411.15(g) and § 411.15(k) of this chapter that may prevent payment for PACE program services that are provided to PACE participants.
The following services are excluded from coverage under PACE:
(a) Any service that is not authorized by the interdisciplinary team, even if it is a required service, unless it is an emergency service.
(b) In an inpatient facility, private room and private duty nursing services (unless medically necessary), and nonmedical items for personal convenience such as telephone charges and radio or television rental (unless specifically authorized by the interdisciplinary team as part of the participant's plan of care).
(c) Cosmetic surgery, which does not include surgery that is required for improved functioning of a malformed part of the body resulting from an accidental injury or for reconstruction following mastectomy.
(d) Experimental medical, surgical, or other health procedures.
(e) Services furnished outside of the United States, except as follows:
(1) In accordance with § 424.122 and § 424.124 of this chapter.
(2) As permitted under the State's approved Medicaid plan.
(a)
(b)
(2) These services must be furnished in at least the PACE center, the home, and inpatient facilities.
(3) The PACE organization may not discriminate against any participant in the delivery of required PACE services based on race, ethnicity, national origin, religion, sex, age, sexual orientation, mental or physical disability, or source of payment.
(c)
(1) Primary care, including physician and nursing services.
(2) Social services.
(3) Restorative therapies, including physical therapy and occupational therapy.
(4) Personal care and supportive services.
(5) Nutritional counseling.
(6) Recreational therapy.
(7) Meals.
(d)
(2) A PACE organization must ensure accessible and adequate services to meet the needs of its participants. If necessary, a PACE organization must increase the number of PACE centers, staff, or other PACE services.
(3) If a PACE organization operates more than one center, each Pace center must offer the full range of services and have sufficient staff to meet the needs of participants.
(e)
(a)
(b)
(1) Are furnished by a qualified emergency services provider, other than the PACE organization or one of its contract providers, either in or out of the PACE organization's service area.
(2) Are needed to evaluate or stabilize an emergency medical condition.
(c) An emergency medical condition means a condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that a prudent layperson, with an average knowledge of health and medicine, could reasonably expect the absence of immediate medical attention to result in the following:
(1) Serious jeopardy to the health of the participant.
(2) Serious impairment to bodily functions.
(3) Serious dysfunction of any bodily organ or part.
(d)
(e)
(1) An on-call provider, available 24-hours per day to address participant questions about emergency services and respond to requests for authorization of urgently needed out-of-network services and post stabilization care services following emergency services.
(2) Coverage of urgently needed out-of-network and post-stabilization care services when either of the following conditions are met:
(i) The services are preapproved by the PACE organization.
(ii) The services are not preapproved by the PACE organization because the PACE organization did not respond to a request for approval within 1 hour after being contacted or cannot be contacted for approval.
(3)
(i) Post stabilization care means services provided subsequent to an emergency that a treating physician views as medically necessary after an emergency medical condition has been stabilized. They are not emergency services, which POs are obligated to cover. Rather, they are non-emergency services that the PO should approve before they are provided outside the service area.
(ii) Urgent care means the care provided to a PACE participant who is out of the PACE service area, and who believes their illness or injury is too severe to postpone treatment until they return to the service area, but their life or function is not in severe jeopardy.
(a)
(1) Establish an interdisciplinary team at each Pace center to comprehensively assess and meet the individual needs of each participant.
(2) Assign each participant to an interdisciplinary team functioning at the PACE center that the participant attends.
(b)
(1) Primary care physician.
(2) Registered nurse.
(3) Master's-level social worker.
(4) Physical therapist.
(5) Occupational therapist.
(6) Recreational therapist or activity coordinator.
(7) Dietitian.
(8) PACE center manager.
(9) Home care coordinator.
(10) Personal care attendant or his or her representative.
(11) Driver or his or her representative.
(c)
(2) Each primary care physician is responsible for the following:
(i) Managing a participant's medical situations.
(ii) Overseeing a participant's use of medical specialists and inpatient care.
(d)
(2) Each team member is responsible for the following:
(i) Regularly informing the interdisciplinary team of the medical, functional, and psychosocial condition of each participant.
(ii) Remaining alert to pertinent input from other team members, participants, and caregivers.
(iii) Documenting changes of a participant's condition in the participant's medical record consistent with documentation polices established by the medical director.
(3) The members of the interdisciplinary team must serve primarily PACE participants.
(e)
(a)
(2) As part of the initial comprehensive assessment, each of the following members of the interdisciplinary team must evaluate the participant in person, at appropriate intervals, and develop a discipline-specific assessment of the participant's health and social status:
(i) Primary care physician.
(ii) Registered nurse.
(iii) Master's-level social worker.
(iv) Physical therapist.
(v) Occupational therapist.
(vi) Recreational therapist or activity coordinator.
(vii) Dietitian.
(viii) Home care coordinator.
(3) At the recommendation of individual team members, other professional disciplines (for example, speech-language pathology, dentistry, or audiology) may be included in the comprehensive assessment process.
(4)
(i) Physical and cognitive function and ability.
(ii) Medication use.
(iii) Participant and caregiver preferences for care.
(iv) Socialization and availability of family support.
(v) Current health status and treatment needs.
(vi) Nutritional status.
(vii) Home environment, including home access and egress.
(viii) Participant behavior.
(ix) Psychosocial status.
(x) Medical and dental status.
(xi) Participant language.
(b)
(c)
(i) Primary care physician.
(ii) Registered nurse.
(iii) Master's-level social worker.
(iv) Recreational therapist or activity coordinator.
(v) Other team members actively involved in the development or implementation of the participant's plan of care, for example, home care coordinator, physical therapist, occupational therapist, or dietitian.
(2)
(i) Physical therapist.
(ii) Occupational therapist.
(iii) Dietitian.
(iv) Home care coordinator.
(d)
(1)
(2)
(i) The PACE organization must have explicit procedures for timely resolution of requests by a participant or his or her designated representative to initiate, eliminate, or continue a particular service.
(ii) Except as provided in paragraph (d)(2)(iii) of this section, the interdisciplinary team must notify the participant or designated representative of its decision to approve or deny the request from the participant or designated representative as expeditiously as the participant's condition requires, but no later than 72 hours after the date the interdisciplinary team receives the request for reassessment.
(iii) The interdisciplinary team may extend the 72-hour timeframe for notifying the participant or designated representative of its decision to approve or deny the request by no more than 5 additional days for either of the following reasons:
(A) The participant or designated representative requests the extension.
(B) The team documents its need for additional information and how the delay is in the interest of the participant.
(iv) The PACE organization must explain any denial of a request to the participant or the participant's designated representative orally and in writing. The PACE organization must provide the specific reasons for the denial in understandable language. The PACE organization is responsible for the following:
(A) Informing the participant or designated representative of his or her right to appeal the decision as specified in § 460.122.
(B) Describing both the standard and expedited appeals processes, including the right to, and conditions for, obtaining expedited consideration of an appeal of a denial of services as specified in § 460.122.
(C) Describing the right to, and conditions for, continuation of appealed services through the period of an appeal as specified in § 460.122(e).
(v) If the interdisciplinary team fails to provide the participant with timely notice of the resolution of the request or does not furnish the services required by the revised plan of care, this failure constitutes an adverse decision, and the participant's request must be automatically processed by the PACE organization as an appeal in accordance with § 460.122.
(e)
(1) Reevaluate the participant's plan of care.
(2) Discuss any changes in the plan with the interdisciplinary team.
(3) Obtain approval of the revised plan from the interdisciplinary team and the participant (or designated representative).
(4) Furnish any services included in the revised plan of care as a result of a reassessment to the participant as expeditiously as the participant's health condition requires.
(f)
(a)
(b)
(1) Specify the care needed to meet the participant's medical, physical, emotional, and social needs, as identified in the initial comprehensive assessment.
(2) Identify measurable outcomes to be achieved.
(c)
(2) The team must continuously monitor the participant's health and psychosocial status, as well as the effectiveness of the plan of care, through the provision of services, informal observation, input from participants or caregivers, and communications among members of the interdisciplinary team and other providers.
(d)
(e)
(f)
(a)
(b)
(c)
(a)
(1) To receive comprehensive health care in a safe and clean environment and in an accessible manner.
(2) To be treated with dignity and respect, be afforded privacy and confidentiality in all aspects of care, and be provided humane care.
(3) Not to be required to perform services for the PACE organization.
(4) To have reasonable access to a telephone.
(5) To be free from harm, including physical or mental abuse, neglect, corporal punishment, involuntary seclusion, excessive medication, and any physical or chemical restraint imposed for purposes of discipline or convenience and not required to treat the participant's medical symptoms.
(6) To be encouraged and assisted to exercise rights as a participant, including the Medicare and Medicaid appeals processes as well as civil and other legal rights.
(7) To be encouraged and assisted to recommend changes in policies and services to PACE staff.
(b)
(1) To be fully informed in writing of the services available from the PACE organization, including identification of all services that are delivered through contracts, rather than furnished directly by the PACE organization at the following times:
(i) Before enrollment.
(ii) At enrollment.
(iii) At the time a participant's needs necessitate the disclosure and delivery of such information in order to allow the participant to make an informed choice.
(2) To have the enrollment agreement, described in § 460.154, fully explained in a manner understood by the participant.
(3) To examine, or upon reasonable request, to be assisted to examine the results of the most recent review of the PACE organization conducted by CMS or the State administering agency and any plan of correction in effect.
(c)
(1) To choose his or her primary care physician and specialists from within the PACE network.
(2) To request that a qualified specialist for women's health services furnish routine or preventive women's health services.
(3) To disenroll from the program at any time.
(d)
(e)
(1) To have all treatment options explained in a culturally competent manner and to make health care decisions, including the right to refuse treatment, and be informed of the consequences of the decisions.
(2) To have the PACE organization explain advance directives and to establish them, if the participant so desires, in accordance with §§ 489.100 and 489.102 of this chapter.
(3) To be fully informed of his or her health and functional status by the interdisciplinary team.
(4) To participate in the development and implementation of the plan of care.
(5) To request a reassessment by the interdisciplinary team.
(6) To be given reasonable advance notice, in writing, of any transfer to another treatment setting and the justification for the transfer (that is, due to medical reasons or for the participant's welfare, or that of other participants). The PACE organization must document the justification in the participant's medical record.
(f)
(1) To be assured of confidential treatment of all information contained in the health record, including information contained in an automated data bank.
(2) To be assured that his or her written consent will be obtained for the release of information to persons not otherwise authorized under law to receive it.
(3) To provide written consent that limits the degree of information and the persons to whom information may be given.
(g)
(1) To be encouraged and assisted to voice complaints to PACE staff and outside representatives of his or her choice, free of any restraint, interference, coercion, discrimination, or reprisal by the PACE staff.
(2) To appeal any treatment decision of the PACE organization, its employees, or contractors through the process described in § 460.122.
(a) The PACE organization must limit use of restraints to the least restrictive and most effective method available. The term restraint includes either a physical restraint or a chemical restraint.
(1) A physical restraint is any manual method or physical or mechanical device, materials, or equipment attached or adjacent to the participant's body that he or she cannot easily remove that restricts freedom of movement or normal access to one's body.
(2) A chemical restraint is a medication used to control behavior or to restrict the participant's freedom of movement and is not a standard treatment for the participant's medical or psychiatric condition.
(b) If the interdisciplinary team determines that a restraint is needed to ensure the participant's physical safety or the safety of others, the use must meet the following conditions:
(1) Be imposed for a defined, limited period of time, based upon the assessed needs of the participant.
(2) Be imposed in accordance with safe and appropriate restraining techniques.
(3) Be imposed only when other less restrictive measures have been found to be ineffective to protect the participant or others from harm.
(4) Be removed or ended at the earliest possible time.
(c) The condition of the restrained participant must be continually assessed, monitored, and reevaluated.
(a)
(b)
(c)
(1) Write the participant rights in English and in any other principal languages of the community.
(2) Display the participant rights in a prominent place in the PACE center.
The PACE organization must have established documented procedures to respond to and rectify a violation of a participant's rights.
For purposes of this part, a grievance is a complaint, either written or oral, expressing dissatisfaction with service delivery or the quality of care furnished.
(a)
(b)
(c)
(1) How a participant files a grievance.
(2) Documentation of a participant's grievance.
(3) Response to, and resolution of, grievances in a timely manner.
(4) Maintenance of confidentiality of a participant's grievance.
(d)
(e)
(f)
For purposes of this section, an appeal is a participant's action taken with respect to the PACE organization's noncoverage of, or nonpayment for, a service including denials, reductions, or termination of services.
(a)
(b)
(c)
(1) Timely preparation and processing of a written denial of coverage or payment as provided in § 460.104(c)(3).
(2) How a participant files an appeal.
(3) Documentation of a participant's appeal.
(4) Appointment of an appropriately credentialed and impartial third party who was not involved in the original action and who does not have a stake in the outcome of the appeal to review the participant's appeal.
(5) Responses to, and resolution of, appeals as expeditiously as the participant's health condition requires, but no later than 30 calendar days after the organization receives an appeal.
(6) Maintenance of confidentiality of appeals.
(d)
(1) Appropriate written notification.
(2) A reasonable opportunity to present evidence related to the dispute, in person, as well as in writing.
(e)
(1) For a Medicaid participant, continue to furnish the disputed services until issuance of the final determination if the following conditions are met:
(i) The PACE organization is proposing to terminate or reduce services currently being furnished to the participant.
(ii) The participant requests continuation with the understanding that he or she may be liable for the costs of the contested services if the determination is not made in his or her favor.
(2) Continue to furnish to the participant all other required services, as specified in subpart F of this part.
(f)
(2) Except as provided in paragraph (f)(3) of this section, the PACE organization must respond to the appeal as expeditiously as the participant's health condition requires, but no later than 72 hours after it receives the appeal.
(3) The PACE organization may extend the 72-hour timeframe by up to 14 calendar days for either of the following reasons:
(i) The participant requests the extension.
(ii) The organization justifies to the State administering agency the need for additional information and how the delay is in the interest of the participant.
(g) Determination in favor of participant. A PACE organization must furnish the disputed service as expeditiously as the participant's health condition requires if a determination is made in favor of the participant on appeal.
(h) Determination adverse to participant. For a determination that is wholly or partially adverse to a participant, at the same time the decision is made, the PACE organization must notify the following:
(1) CMS.
(2) The State administering agency.
(3) The participant.
(i)
A PACE organization must inform a participant in writing of his or her appeal rights under Medicare or Medicaid managed care, or both, assist the participant in choosing which to pursue if both are applicable, and forward the appeal to the appropriate external entity.
(a) A PACE organization must develop, implement, maintain, and evaluate an effective, data-driven quality assessment and performance improvement program.
(b) The program must reflect the full range of services furnished by the PACE organization.
(c) A PACE organization must take actions that result in improvements in its performance in all types of care.
(a)
(b)
(c)
(1) Identify areas to improve or maintain the delivery of services and patient care.
(2) Develop and implement plans of action to improve or maintain quality of care.
(3) Document and disseminate to PACE staff and contractors the results from the quality assessment and performance improvement activities.
(a)
(1) Utilization of PACE services, such as decreased inpatient hospitalizations and emergency room visits.
(2) Caregiver and participant satisfaction.
(3) Outcome measures that are derived from data collected during assessments, including data on the following:
(i) Physiological well being.
(ii) Functional status.
(iii) Cognitive ability.
(iv) Social/behavioral functioning.
(v) Quality of life of participants.
(4) Effectiveness and safety of staff-provided and contracted services, including the following:
(i) Competency of clinical staff.
(ii) Promptness of service delivery.
(iii) Achievement of treatment goals and measurable outcomes.
(5) Nonclinical areas, such as grievances and appeals, transportation services, meals, life safety, and environmental issues.
(b)
(c)
(d)
(a)
(1) Use a set of outcome measures to identify areas of good or problematic performance.
(2) Take actions targeted at maintaining or improving care based on outcome measures.
(3) Incorporate actions resulting in performance improvement into standards of practice for the delivery of care and periodically track performance to ensure that any performance improvements are sustained over time.
(4) Set priorities for performance improvement, considering prevalence and severity of identified problems, and give priority to improvement activities that affect clinical outcomes.
(5) Immediately correct any identified problem that directly or potentially threatens the health and safety of a PACE participant.
(b)
(c)
(2) The quality improvement coordinator must encourage a PACE participant and his or her caregivers to be involved in quality assessment and performance improvement activities, including providing information about their satisfaction with services.
A PACE organization must establish one or more committees, with community input, to do the following:
(a) Evaluate data collected pertaining to quality outcome measures.
(b) Address the implementation of, and results from, the quality assessment and performance improvement plan.
(c) Provide input related to ethical decisionmaking, including end-of-life issues and implementation of the Patient Self-Determination Act.
A PACE organization must meet external quality assessment and reporting requirements, as specified by CMS or the State administering agency, in accordance with § 460.202.
(a)
(b)
(1) Be 55 years of age or older.
(2) Be determined by the State administering agency to need the level of care required under the State Medicaid plan for coverage of nursing facility services, which indicates that the individual's health status is comparable to the health status of individuals who have participated in the PACE demonstration waiver programs.
(3) Reside in the service area of the PACE organization.
(4) Meet any additional program specific eligibility conditions imposed under the PACE program agreement. These additional conditions may not modify the requirements of paragraph (b)(1) through (b)(3) of this section.
(c)
(2) The criteria used to determine if an individual's health or safety would be jeopardized by living in a community setting must be specified in the program agreement.
(d)
(1) Entitled to Medicare Part A.
(2) Enrolled under Medicare Part B.
(3) Eligible for Medicaid.
(a)
(1) The PACE staff must explain to the potential participant and his or her representative or caregiver the following information:
(i) The PACE program, using a copy of the enrollment agreement described in § 460.154, specifically references the elements of the agreement including but not limited to § 460.154(e), (i) through (m), and (r).
(ii) The requirement that the PACE organization would be the participant's sole service provider and clarification that the PACE organization guarantees access to services, but not to a specific provider.
(iii) A list of the employees of the PACE organization who furnish care and the most current list of contracted health care providers under § 460.70(c).
(iv) Monthly premiums, if any.
(v) Any Medicaid spenddown obligations.
(vi) Post-eligibility treatment of income.
(2) The potential participant must sign a release to allow the PACE organization to obtain his or her medical and financial information and eligibility status for Medicare and Medicaid.
(3) The State administering agency must assess the potential participant, including any individual who is not eligible for Medicaid, to ensure that he or she needs the level of care required under the State Medicaid plan for coverage of nursing facility services, which indicates that the individual's health status is comparable to the health status of individuals who have participated in the PACE demonstration waiver programs.
(4) PACE staff must assess the potential participant to ensure that he or she can be cared for appropriately in a community setting and that he or she meets all requirements for PACE eligibility specified in this part.
(b)
(1) Notify the individual in writing of the reason for the denial.
(2) Refer the individual to alternative services, as appropriate.
(3) Maintain supporting documentation of the reason for the denial.
(4) Notify CMS and the State administering agency and make the documentation available for review.
If the potential participant meets the eligibility requirements and wants to enroll, he or she must sign an enrollment agreement which contains, at a minimum, the following information:
(a) Applicant's name, sex, and date of birth.
(b) Medicare beneficiary status (Part A, Part B, or both) and number, if applicable.
(c) Medicaid recipient status and number, if applicable.
(d) Other health insurance information, if applicable.
(e) Conditions for enrollment and disenrollment in PACE.
(f) Description of participant premiums, if any, and procedures for payment of premiums.
(g) Notification that a Medicaid participant and a participant who is eligible for both Medicare and Medicaid are not liable for any premiums, but may be liable for any applicable spenddown liability under §§ 435.121 and 435.831 of this chapter and any amounts due under the post-eligibility treatment of income process under § 460.184.
(h) Notification that a Medicare participant may not enroll or disenroll at a Social Security office.
(i) Notification that enrollment in PACE results in disenrollment from any other Medicare or Medicaid prepayment plan or optional benefit. Electing enrollment in any other Medicare or Medicaid prepayment plan or optional benefit, including the hospice benefit, after enrolling as a PACE participant is considered a voluntary disenrollment from PACE.
(j) Information on the consequences of subsequent enrollment in other optional Medicare or Medicaid programs following disenrollment from PACE.
(k) Description of PACE services available, including all Medicare and Medicaid covered services, and how services are obtained from the PACE organization.
(l) Description of the procedures for obtaining emergency and urgently needed out-of-network services.
(m) The participant bill of rights.
(n) Information on the process for grievances and appeals and Medicare/Medicaid phone numbers for use in appeals.
(o) Notification of a participant's obligation to inform the PACE organization of a move or lengthy absence from the organization's service area.
(p) An acknowledgment by the applicant or representative that he or she understands the requirement that the PACE organization must be the applicant's sole service provider.
(q) A statement that the PACE organization has an agreement with CMS and the State administering agency that is subject to renewal on a periodic basis and, if the agreement is not renewed, the program will be terminated.
(r) The applicant's authorization for disclosure and exchange of personal information between CMS, its agents, the State administering agency, and the PACE organization.
(s) The effective date of enrollment.
(t) The signature of the applicant or his or her designated representative and the date.
(a)
(1) A copy of the enrollment agreement.
(2) A PACE membership card.
(3) Emergency information to be posted in his or her home identifying the individual as a PACE participant and explaining how to access emergency services.
(4) Stickers for the participant's Medicare and Medicaid cards, as applicable, which indicate that he or she is a PACE participant and include the phone number of the PACE organization.
(b)
(c)
(1) Give an updated copy of the information to the participant.
(2) Explain the changes to the participant and his or her representative or caregiver in a manner they understand.
A participant's enrollment in the program is effective on the first day of the calendar month following the date the PACE organization receives the signed enrollment agreement.
(a)
(1) The participant voluntarily disenrolls.
(2) The participant is involuntarily disenrolled, as described in § 460.164.
(b)
(1)
(ii) The PACE organization must retain in the participant's medical record the documentation of the reason for waiving the annual recertification requirement.
(2)
(3)
(ii) The criteria used to make the determination of continued eligibility must be specified in the program agreement.
A PACE participant may voluntarily disenroll from the program without cause at any time.
(a)
(1) The participant fails to pay, or to make satisfactory arrangements to pay, any premium due the PACE organization after a 30-day grace period.
(2) The participant engages in disruptive or threatening behavior, as described in paragraph (b) of this section.
(3) The participant moves out of the PACE program service area or is out of the service area for more than 30 consecutive days, unless the PACE organization agrees to a longer absence due to extenuating circumstances.
(4) The participant is determined to no longer meet the State Medicaid nursing facility level of care requirements and is not deemed eligible.
(5) The PACE program agreement with CMS and the State administering agency is not renewed or is terminated.
(6) The PACE organization is unable to offer health care services due to the loss of State licenses or contracts with outside providers.
(b)
(1) A participant whose behavior jeopardizes his or her health or safety, or the safety of others; or
(2) A participant with decision-making capacity who consistently refuses to comply with his or her individual plan of care or the terms of the PACE enrollment agreement.
(c)
(1) The reasons for proposing to disenroll the participant.
(2) All efforts to remedy the situation.
(d)
(2) For purposes of this section, noncompliant behavior includes repeated noncompliance with medical advice and repeated failure to keep appointments.
(e)
(a) In disenrolling a participant, the PACE organization must take the following actions:
(1) Use the most expedient process allowed under Medicare and Medicaid procedures, as set forth in the PACE program agreement.
(2) Coordinate the disenrollment date between Medicare and Medicaid (for a participant who is eligible for both Medicare and Medicaid).
(3) Give reasonable advance notice to the participant.
(b) Until the date enrollment is terminated, the following requirements must be met:
(1) PACE participants must continue to use PACE organization services and remain liable for any premiums.
(2) The PACE organization must continue to furnish all needed services.
To facilitate a participant's reinstatement in other Medicare and Medicaid programs after disenrollment, the PACE organization must do the following:
(a) Make appropriate referrals and ensure medical records are made available to new providers in a timely manner.
(b) Work with CMS and the State administering agency to reinstate the participant in other Medicare and Medicaid programs for which the participant is eligible.
(a) A previously disenrolled participant may be reinstated in a PACE program.
(b) If the reason for disenrollment is failure to pay the premium and the participant pays the premium before the effective date of disenrollment, the participant is reinstated in the PACE program with no break in coverage.
A PACE organization must meet the following requirements:
(a) Have a procedure in place to document the reasons for all voluntary and involuntary disenrollments.
(b) Make documentation available for review by CMS and the State administering agency.
(c) Use the information on voluntary disenrollments in the PACE organization's internal quality assessment and performance improvement program.
(a)
(b)
(2) Except as specified in paragraph (b)(4) of this section, the monthly capitation amount is based on the Part A and Part B payment rates established for purposes of payment to Medicare Advantage organizations. As used in this section, “Medicare Advantage rates” means the Part A and Part B rates calculated by CMS for making payment to Medicare Advantage organizations under section 1853(c) of the Act.
(3) CMS will adjust the monthly capitation payment amount derived under paragraph (b)(2) of this section based on a risk adjustment that reflects the individual's health status. CMS will ensure that payments take into account the comparative frailty of PACE enrollees relative to the general Medicare population.
(4) For Medicare participants who require ESRD services, the monthly capitation amount is based on the Medicare Advantage ESRD risk adjustment model.
(5) CMS may adjust the monthly capitation amount to take into account other factors CMS determines to be appropriate.
(6) The monthly capitation payment is a fixed amount, regardless of changes in the participant's health status.
(7) The monthly capitation payment amount is an all-inclusive payment for Medicare benefits provided to participants. A PACE organization must not seek any additional payment from Medicare. The only additional payment that a PACE organization may collect from, or on behalf of, a Medicare participant for PACE services is the following:
(i) Any applicable premium amount specified in § 460.186.
(ii) Any charge permitted under paragraph (d) of this section when Medicare is not the primary payer.
(iii) Any payment from the State, as specified in § 460.182, for a participant who is eligible for both Medicare and Medicaid.
(iv) Payment with respect to any applicable spenddown liability under §§ 435.121 and 435.831 of this chapter and any amount due under the post-eligibility treatment of income process under § 460.184 for a participant who is eligible for both Medicare and Medicaid.
(8) CMS computes the Medicare monthly capitation payment amount under a PACE program agreement so that the total payment level for all participants is less than the projected payment under Medicare for a comparable population not enrolled under a PACE program.
(c)
(d)
(2)
(i) Identify payers that are primary to Medicare under part 411 of this chapter.
(ii) Determine the amounts payable by those payers.
(iii) Coordinate benefits to Medicare participants with the benefits of the primary payers.
(3)
(4)
(i) The insurance carrier, the employer, or any other entity that is liable for payment for the services under part 411 of this chapter.
(ii) The Medicare participant, to the extent that he or she has been paid by the carrier, employer, or other entity.
(5)
(i) GHP or LGHP for those services.
(ii) Medicare participant to the extent that he or she has been paid by the GHP or LGHP for those services.
(a) Under a PACE program agreement, the State administering agency makes a prospective monthly payment to the PACE organization of a capitation amount for each Medicaid participant.
(b) The monthly capitation payment amount is negotiated between the PACE organization and the State administering agency, and specified in the PACE program agreement. The amount represents the following:
(1) Is less than the amount that would otherwise have been paid under the State plan if the participants were not enrolled under the PACE program.
(2) Takes into account the comparative frailty of PACE participants.
(3) Is a fixed amount regardless of changes in the participant's health status.
(4) Can be renegotiated on an annual basis.
(c) The PACE organization must accept the capitation payment amount as payment in full for Medicaid participants and may not bill, charge, collect, or receive any other form of payment from the State administering agency or from, or on behalf of, the participant, except as follows:
(1) Payment with respect to any applicable spenddown liability under §§ 435.121 and 435.831 of this chapter and any amounts due under the post-eligibility treatment of income process under § 460.184.
(2) Medicare payment received from CMS or from other payers, in accordance with § 460.180(d).
(d) State procedures for the enrollment and disenrollment of participants in the State's system, including procedures for any adjustment to account for the difference between the estimated number of participants on which the prospective monthly payment was based and the actual number of participants in that month, are included in the PACE program agreement.
(a) A State may provide for post-eligibility treatment of income for Medicaid participants in the same manner as a State treats post-eligibility income for individuals receiving services under a waiver under section 1915(c) of the Act.
(b) Post-eligibility treatment of income is applied as it is under a waiver of section 1915(c) of the Act, as specified in §§ 435.726 and 435.735 of this chapter, and section 1924 of the Act.
The amount that a PACE organization can charge a participant as a monthly premium depends on the participant's eligibility under Medicare and Medicaid, as follows:
(a)
(b)
(c)
(d)
(a)
(b)
(1) An onsite visit to the PACE organization, which may include, but is not limited to, the following:
(i) Review of participants' charts.
(ii) Interviews with staff.
(iii) Interviews with participants and caregivers.
(iv) Interviews with contractors.
(v) Observation of program operations, including marketing, participant services, enrollment and disenrollment procedures, grievances, and appeals.
(2) A comprehensive assessment of an organization's fiscal soundness.
(3) A comprehensive assessment of the organization's capacity to furnish all PACE services to all participants.
(4) Any other elements that CMS or the State administering agency find necessary.
(a) At the conclusion of the trial period, CMS, in cooperation with the State administering agency, continues to conduct reviews of a PACE organization, as appropriate, taking into account the quality of care furnished and the organization's compliance with all of the requirements of this part.
(b) Reviews include an on-site visit at least every 2 years.
(a) A PACE organization must take action to correct deficiencies identified during reviews.
(b) CMS or the State administering agency monitors the effectiveness of corrective actions.
(c) Failure to correct deficiencies may result in sanctions or termination, as specified in subpart D of this part.
(a) CMS and the State administering agency promptly report the results of reviews under §§ 460.190 and 460.192 to the PACE organization, along with any recommendations for changes to the organization's program.
(b) CMS and the State administering agency make the results of reviews available to the public upon request.
(c) The PACE organization must post a notice of the availability of the results of the most recent review and any plans of correction or responses related to the most recent review.
(d) The PACE organization must make the review results available for examination in a place readily accessible to participants.
(a)
(b)
(1) Participant health outcomes data.
(2) Financial books and records.
(3) Medical records.
(4) Personnel records.
(c)
(d)
(e)
(1) Safeguard the privacy of any information that identifies a particular participant. Information from, or copies of, records may be released only to authorized individuals. Original medical records are released only in accordance with Federal or State laws, court orders, or subpoenas.
(2) Maintain complete records and relevant information in an accurate and timely manner.
(3) Grant each participant timely access, upon request, to review and copy his or her own medical records and to request amendments to those records.
(4) Abide by all Federal and State laws regarding confidentiality and disclosure for mental health records, medical records, and other participant health information.
(f)
(i) The period of time specified in State law.
(ii) Six years from the last entry date.
(iii) For medical records of disenrolled participants, 6 years after the date of disenrollment.
(2) If litigation, a claim, a financial management review, or an audit arising from the operation of the PACE program is started before the expiration of the retention period, specified in paragraph (f)(1) of this section, the PACE organization must retain the records until the completion of the litigation, or resolution of the claims or audit findings.
(a) A PACE organization must establish and maintain a health information system that collects, analyzes, integrates, and reports data necessary to measure the organization's performance, including outcomes of care furnished to participants.
(b) A PACE organization must furnish data and information pertaining to its provision of participant care in the manner, and at the time intervals, specified by CMS and the State administering agency. The items collected are specified in the PACE program agreement.
(a)
(1) Prepared using an accrual basis of accounting; and
(2) Verifiable by qualified auditors.
(b)
(1) Accurately documents all financial transactions.
(2) Provides an audit trail to source documents.
(3) Generates financial statements.
(c)
(d)
(1) Any aspect of services furnished.
(2) Reconciliation of participants' benefit liabilities.
(3) Determination of Medicare and Medicaid amounts payable.
(a)
(2) The financial statement must be certified by an independent certified public accountant.
(b)
(1) A certification statement.
(2) A balance sheet.
(3) A statement of revenues and expenses.
(4) A source and use of funds statement.
(c)
(2)
(a)
(2) The medical record for each participant must meet the following requirements:
(i) Be complete.
(ii) Accurately documented.
(iii) Readily accessible.
(iv) Systematically organized.
(v) Available to all staff.
(vi) Maintained and housed at the PACE center where the participant receives services.
(b)
(1) Appropriate identifying information.
(2) Documentation of all services furnished, including the following:
(i) A summary of emergency care and other inpatient or long-term care services.
(ii) Services furnished by employees of the PACE center.
(iii) Services furnished by contractors and their reports.
(3) Interdisciplinary assessments, reassessments, plans of care, treatment, and progress notes that include the participant's response to treatment.
(4) Laboratory, radiological and other test reports.
(5) Medication records.
(6) Hospital discharge summaries, if applicable.
(7) Reports of contact with informal support (for example, caregiver, legal guardian, or next of kin).
(8) Enrollment Agreement.
(9) Physician orders.
(10) Discharge summary and disenrollment justification, if applicable.
(11) Advance directives, if applicable.
(12) A signed release permitting disclosure of personal information.
(c)
(d)
(2) Authentication must include signatures or a secured computer entry by a unique identifier of the primary author who has reviewed and approved the entry.
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
For purposes of this part:
(a) Has an ownership interest of 5 percent or more;
(b) Has an indirect ownership interest equal to 5 percent or more;
(c) Has a combination of direct and indirect ownership interests (the possession of equity in the capital, the stock, or the profits of an entity) equal to 5 percent or more; or
(d) Is the owner of an interest of 5 percent or more in any obligation secured by an entity, if the interest equals at least 5 percent of the value of the property or assets of the entity.
(1) A doctor of medicine or osteopathy licensed under State law to practice medicine, surgery, or osteopathy in the State in which the QIO is located;
(2) An intern, resident, or Federal Government employee authorized under State or Federal law to practice medicine, surgery, or osteopathy in the QIO area; and
(3) An individual licensed to practice medicine in American Samoa, the Northern Mariana Islands, and the Trust Territory of the Pacific Islands.
This subpart implements sections 1152 and 1153(b) of the Social Security Act as amended by the Peer Review Improvement Act of 1982 (Pub. L. 97-248). It defines the types of organizations eligible to become QIOs and establishes certain limitations and priorities regarding QIO contracting.
In order to be eligible for a QIO contract an organization must—
(a) Be either a physician-sponsored organization as described in § 462.102; or a physician-access organization as described in § 462.103; and
(b) Demonstrate its ability to perform review as set forth in § 462.104.
(a) In order to be eligible for designation as a physician-sponsored QIO, an organization must meet the following conditions:
(1) Be composed of a substantial number of the licensed doctors of medicine and osteopathy practicing medicine or surgery in the review area and who are representative of the physicians practicing in the area.
(2) Not be a health care facility, health care facility association, or health care facility affiliate, as specified in § 462.105.
(b) In order to meet the requirements of paragraph (a)(1) of this section, an organization must state and have documentation in its files showing that it is composed of at least 10 percent of the licensed doctors of medicine and osteopathy practicing medicine or surgery in the review area.
(c) In order to meet the requirements or paragraph (a)(2) of this section, an organization must—
(1) State and have documentation in its files demonstrating that it is composed of at least 20 percent of the licensed doctors of medicine and osteopathy practicing medicine or surgery in the review area; or
(2) If the organization is not composed of at least 20 percent of the licensed doctors of medicine and osteopathy practicing medicine or surgery in the review area, then the organization must demonstrate in its contract proposal, through letters of support from physicians or physician organizations, or through other means, that it is representative of the area physicians.
(d) Organizations that meet the requirements in paragraph (a) of this section will receive, during the contract evaluation process, a set number of bonus points.
(a) In order to be eligible for designation as a physician-access QIO, an organization must meet the following conditions:
(1) Have available to it, by arrangement or otherwise, the services of a sufficient number of licensed doctors of medicine or osteopathy practicing medicine or surgery in the review area to assure adequate peer review of the services provided by the various medical specialties and subspecialties.
(2) Not be a health care facility, health care facility association, or health care facility affiliate, as specified in § 462.105.
(b) An organization meets the requirements of paragraph (a)(1) of this section if it demonstrates—
(1) That it has available to it at least one physician in every generally recognized specialty; and
(2) The existence of an arrangement or arrangements with physicians under which the physicians would conduct review for the organization.
(a) A physician-sponsored or physician-access organization will be found capable of conducting review if CMS determines that the organization is able to set quantifiable performance objectives and perform the utilization and quality review functions established under section 1154 of the Social Security Act in an efficient and effective manner.
(b) CMS will determine that the organization is capable of conducting utilization and quality review if—
(1) The organization's proposed review system is adequate; and
(2) The organization has available sufficient resources (including access to medical review skills) to implement that system; and
(3) The organization's quantifiable objectives are acceptable.
(c) CMS may consider prior similar review experience in making determinations under paragraph (b) of this section.
(d) A State government that operates a Medicaid program will be considered incapable of performing utilization and quality review functions in an effective manner, unless the State demonstrates to the satisfaction of CMS that it will act with complete independence and objectivity.
(a)
(1) A health care facility in the QIO area.
(2) An association of health care facilities in the QIO area.
(3) A health care facility affiliate; that is, an organization in which more than 20 percent of the members of the governing body are also either a governing body member, officer, partner, five percent or more owner, or managing employee in a health care facility or association of health care facilities in the QIO area.
(b)
(c)
Payor organizations are not eligible to become QIOs for the area in which they make payments until November 15, 1984. If no QIO contract for an area is awarded before November 15, 1984, a payor organization will be determined eligible by CMS, if an eligible organization that is not a payor organization is unavailable at that time. CMS may determine the unavailability of nonpayor organizations based on the lack of response to an appropriate Request for Proposal.
CMS, in awarding QIO contracts, will take the following actions—
(a) Identify from among all proposals submitted in response to an RFP for a given QIO area all proposals submitted by organizations that meet the requirements of § 462.102 or § 462.103;
(b) Identify from among all proposals identified in paragraph (a) of this section all proposals that set forth minimally acceptable plans in accordance with the requirements of § 462.104 and the RFPs;
(c) Assign bonus points not to exceed 10% of the total points available to all physician-sponsored organizations identified in paragraph (b) of this section, consistent with statute; and
(d) Subject to the limitations established by §§ 462.105 and 462.106, award the contract for the given QIO area to the selected organization for a period of two years.
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
As used in this part, unless the context indicates otherwise:
(a) Has an ownership interest of 5 percent or more;
(b) Has an indirect ownership interest equal to 5 percent or more;
(c) Has a combination of direct and indirect ownership interests (the possession of equity in the capital, the stock, or the profits of an entity) equal to five percent or more; or
(d) Is the owner of an interest of five percent or more in any obligation secured by an entity, if the interest equals at least five percent of the value of the property or assets of the entity.
(a)
(b)
(a)
(1) Whether the services are or were reasonable and medically necessary for the diagnosis and treatment of illness or injury or to improve functioning of a malformed body member, or (with respect to pneumococcal vaccine) for prevention of illness or (in the case of hospice care) for the palliation and management of terminal illness;
(2) Whether the quality of the services meets professionally recognized standards of health care;
(3) Whether those services furnished or proposed to be furnished on an inpatient basis could, consistent with the provisions of appropriate medical care, be effectively furnished more economically on an outpatient basis or in an inpatient health care facility of a different type;
(4) Through DRG validation, the validity of diagnostic and procedural information supplied by the hospital;
(5) The completeness, adequacy and quality of hospital care provided;
(6) The medical necessity, reasonableness and appropriateness of hospital admissions and discharges;
(7) The medical necessity, reasonableness and appropriateness of inpatient hospital care for which additional payment is sought under the outlier provisions of §§ 412.82 and 412.84 of this chapter; and
(8) Whether a hospital has misrepresented admission or discharge information or has taken an action that results in—
(i) The unnecessary admission of an individual entitled to benefits under part A;
(ii) Unnecessary multiple admissions of an individual; or
(iii) Other inappropriate medical or other practices with respect to beneficiaries or billing for services furnished to beneficiaries.
(b)
(c)
(2) As directed by CMS, the QIO must review changes in DRG and LTC-DRG assignments made by the intermediary under the provisions of §§ 412.60(d) and 412.513(c) of this chapter that result in the assignment of a higher-weighted DRG or a different LTC-DRG. The QIO's review must verify that the diagnostic and procedural information supplied by the hospital is substantiated by the information in the medical record.
(d)
(a) (1) For purposes of a review under section 1154(a)(4) of the Act, a QIO must determine whether the quality of services (including both inpatient and outpatient services) provided by an HMO or CMP meets professionally recognized standards of health care, including whether appropriate health care services have not been provided or have been provided in inappropriate settings.
(2) Paragraph (a)(1) of this section will not apply with respect to a contract year if another entity has been awarded a contract to perform those reviews under section 1154(a)(4)(C) of the Act.
(b) For purposes of reviews under this section, non-QIO entities selected to perform these reviews under section 1154(a)(4)(C) of the Act are subject to the requirements of paragraph (a)(1) of this section and—
(1) Part 476 of this chapter regarding acquisition, protection, and disclosure of peer review information; and
(2) Part 1004 of Chapter V regarding a QIO's responsibilities, and sanctions on health care practitioners and providers.
(a)
(b)
(1) Provide, to each health care facility scheduled to come under review, a timely written notice that specifies the date and manner in which the QIO proposes to implement review, and the information to be furnished by the facility to each Medicare beneficiary upon admission as specified in § 466.78(b)(3) of this part.
(2) Publish, in at least one local newspaper of general circulation in the QIO area, a notice that states the date the QIO will assume review responsibilities and lists each area health care facility to be under review. The QIO must indicate that its plan for the review of health care services as approved in its contract with CMS is available for public inspection in the QIO's business office and give the address, telephone number and usual hours of business.
(a) A QIO must assume review responsibility in accordance with the schedule, functions and negotiated objectives specified in its contract with CMS.
(b) A QIO must notify the appropriate Medicare fiscal intermediary or carrier of its assumption of review in specific health care facilities no later than five working days after the day that review is assumed in the facility.
(c) A QIO must maintain and make available for public inspection at its principal business office—
(1) A copy of each agreement with Medicare fiscal intermediaries and carriers;
(2) A copy of its currently approved review plan that includes the QIO's method for implementing review; and
(3) Copies of all subcontracts for the conduct of review.
(d) A QIO must not subcontract with a facility to conduct any review activities except for the review of the quality of care. The QIO may subcontract with a non-facility organization to conduct review in a facility.
(e) If required by CMS, a QIO is responsible for compiling statistics based on the criteria contained in § 405.332 of this chapter and making limitation of liability determinations on excluded coverage of certain services that are made under section 1879 of the Act. If required by CMS, QIOs must also notify a provider of these determinations. These determinations and further appeals are governed by the reconsideration and appeals procedures in part 405, subpart G of this chapter for Medicare Part A related determinations and part 405, subpart H of this chapter for Medicare Part B related determinations.
(f) A QIO must make its responsibilities under its contract with CMS, primary to all other interests and activities that the QIO undertakes.
Before implementation of review, a QIO must make a good faith effort to discuss the QIO's administrative and review procedures with each involved health care facility.
(a) Every hospital seeking payment for services furnished to Medicare beneficiaries must maintain a written agreement with a QIO operating in the area in which the hospital is located. These agreements must provide for the QIO review specified in § 466.71.
(b)
(1) Allocate adequate space to the QIO for its conduct of review at the times the QIO is conducting review.
(2) Provide patient care data and other pertinent data to the QIO at the time the QIO is collecting review information that is required for the QIO to make its determinations. The provider must photocopy and deliver to the QIO all required information within 30 days of a request. QIOs pay providers paid under the prospective payment system for the costs of photocopying records requested by the QIO in accordance with the payment rate determined under the methodology described in paragraph (c) of this section and for first class postage for mailing the records to the QIO. When the QIO does postadmission, preprocedure review, the facility must provide the necessary information before the procedure is performed, unless it must be performed on an emergency basis.
(3) Inform Medicare beneficiaries at the time of admission, in writing, that the care for which Medicare payment is sought will be subject to QIO review and indicate the potential outcomes of that review. Furnishing this information to the patient does not constitute notice, under § 405.332(a) of this chapter, that can support a finding that the beneficiary knew the services were not covered.
(4) When the facility has issued a written determination in accordance with § 412.42(c)(3) of this chapter that a beneficiary no longer requries inpatient hospital care, it must submit a copy of its determination to the QIO within 3 working days.
(5) Assure, in accordance with the provisions of its agreement with the QIO, that each case subject to preadmission review has been reviewed and approved by the QIO before admission to the hospital or a timely request has been made for QIO review.
(6)(i) Agree to accept financial liability for any admission subject to preadmission review that was not reviewed by the QIO and is subsequently determined to be inappropriate or not medically necessary.
(ii) The provisions of paragraph (b)(6)(i) of this section do not apply if a facility, in accordance with its agreement with a QIO, makes a timely request for preadmission review and the QIO does not review the case timely. Cases of this type are subject to retrospective prepayment review under paragraph (b)(7) of this section.
(7) Agree that, if the hospital admits a case subject to preadmission review without certification, the case must receive retrospective prepayment review, according to the review priority established by the QIO.
(c)
(1)
(2)
(3) CMS adds to the per-page labor cost determined in paragraph (c)(2) of this section the per-page costs of supplies.
(4) CMS will periodically review the photocopy reimbursement rate to ensure that it still accurately reflects provider costs. CMS will publish any changes to the rate in a
(d)
(a)
(1) The QIO and the fiscal intermediary or carrier must negotiate in good faith in an effort to reach written agreement. If they cannot reach agreement, CMS will assist them in resolving matters in dispute.
(2) The QIO must incorporate its administrative procedures into an agreement with the fiscal intermediary or carrier and obtain approval from CMS, before it makes conclusive determinations for the Medicare program, unless CMS finds that the fiscal intermediary or carrier has—
(i) Refused to negotiate in good faith or in a timely manner, or
(ii) Insisted on including in the agreement, provisions that are outside the scope of its authority under the Act.
(b)
(1) Informing the appropriate Medicare fiscal intermediaries and carriers of—
(i) Changes as a result of DRG validations and revisions as a result of the review of these changes; and
(ii) Initial denial determinations and revisions of these determinations as a result of reconsideration, or reopening all approvals and denials with respect to cases subject to preadmission review, and outlier claims in hospitals under a prospective payment system for health care services and items;
(2) Exchanging data or information;
(3) Modifying the procedures when additional review responsibility is authorized by CMS; and
(4) Any other matters that are necessary for the coordination of functions.
(c)
(2) If CMS approves the agreement or the administrative procedures (after a finding by CMS as specified in paragraph (a)(2) of this section), the QIO may begin to make determinations under its contract with CMS.
(3) If CMS disapproves the agreement or procedures, it will—
(i) Notify the QIO and the appropriate fiscal agents in writing, stating the reasons for disapproval; and
(ii) Require the QIO and fiscal intermediary or carrier to revise its agreements or procedures.
(d)
(1) Through a revised agreement with the fiscal intermediary or carrier, or
(2) In the case of procedures, by the QIO, after providing opportunity for comment by the fiscal intermediary or carrier.
(e)
(2) A QIO's determination that an admission is medically necessary is not a guarantee of payment by the fiscal intermediary. Medicare coverage requirements must also be applied.
Any of the duties and functions under Part B of Title XI of the Act for which a QIO has not assumed responsibility under its contract with CMS must be
A determination by a QIO that the health care services furnished or proposed to be furnished to a patient are not medically necessary, are not reasonable, or are not at the appropriate level of care, is an initial denial determination and is appealable under part 473 of this chapter.
A provider or practitioner may obtain a review by a QIO under part 473 of this chapter for changes in diagnostic and procedural coding that resulted in a change in DRG assignment as a result of QIO validation activities.
A QIO initial denial determination or change as a result of DRG validation is final and binding unless, in accordance with the procedures in part 473—
(a) The initial denial determination is reconsidered and revised; or
(b) The change as a result of DRG validation is reviewed and revised.
(a)
(i) Whether inpatient care furnished in a psychiatric hospital meets the requirements of § 424.14 of this chapter.
(ii) Whether payment for inpatient hospital or SNF care beyond 20 consecutive days is precluded under § 489.50 of this chapter because of failure to perform review of long-stay cases.
(iii) Whether the care furnished was custodial care or care not reasonable and necessary and, as such, excluded under § 405.310(g) or § 405.310(k) of this chapter.
(iv) Whether the care was appropriately furnished in the inpatient or outpatient setting.
(2) Reviews with respect to determinations listed in paragraph (a)(1) of this section must not be conducted, for purposes of payment, by Medicare fiscal intermediaries or carriers except as outlined in paragraph (c) of this section.
(3) QIOs make determinations as to the appropriateness of the location in which procedures are performed. A procedure may be medically necessary but denied if the QIO determines that it could, consistent with the provision of appropriate medical care, be effectively provided more economically on an outpatient basis or in an inpatient health care facility of a different type.
(4) QIO determinations as to whether the provider and the beneficiary knew or could reasonably be expected to have known that the services described in paragraph (a)(1) of this section were excluded are also conclusive for payment purposes.
(b)
(c)
(1) In the case of items or services not reviewed by a QIO, whether they meet coverage requirements of Title XVIII relating to medical necessity, reasonableness, or appropriateness of placement at an acute level of patient care. However, if a coverage determination pertains to medical necessity, reasonableness, or appropriateness of placement at an acute level of patient care, the fiscal intermediary or carrier
(2) Whether any claim meets coverage requirements of Title XVIII relating to issues other than medical necessity, reasonableness or appropriateness of placement at an acute level of patient care.
(d)
(e)
(f)
(a)
(1) Perform review functions including, but not limited to—
(i) DRG validation;
(ii) Outlier review in facilities under a prospective payment system; and
(iii) Implementation of corrective action and fraud and abuse prevention activities;
(2) Evaluate cases that have been identified as deviating from the QIO norms and criteria, or standards; and
(3) Evaluate the capability of the facility to perform quality review functions under a subcontract with the QIO.
(b)
(1) The records relate to review performed under a non-Medicare QIO contract and if authorized by those patients in accordance with State law; or
(2) The QIO needs the records to perform its quality review responsibilities under the Act and receives authorization from the facility or practitioner.
(c)
(1) Examine only those operations and records (including information on charges) required to fulfill the purposes of paragraph (a) of this section;
(2) Cooperate with agencies responsible for other examination functions under Federal or Federally assisted programs in order to minimize duplication of effort;
(3) Conduct the examinations during reasonable hours; and
(4) Maintain in its principal office written records of the results of the examination of the facility.
(a) If a health care facility or practitioner refuses to allow a QIO to enter and perform the duties and functions required under its contract with CMS, the QIO may—
(1) Determine that the health care facility or practitioner has failed to comply with the requirements of § 474.30(c) of this chapter and report the matter to the HHS Inspector General; or
(2) Issue initial denial determinations for those claims it is unable to review, make the determination that financial liability will be assigned to the health care facility, and report the matter to the HHS Inspector General.
(b) If a QIO provides a facility with sufficient notice and a reasonable amount of time to respond to a request for information about a claim, and if
Before a QIO reaches an initial denial determination or makes a change as a result of a DRG validation, it must—
(a) Promptly notify the provider or supplier and the patient's attending physician (or other attending health care practitioner) of the proposed determination or DRG change; and
(b) Afford an opportunity for the provider or supplier and the physician (or other attending health care practitioner) to discuss the matter with the QIO physician advisor and to explain the nature of the patient's need for health care services, including all factors which preclude treatment of the patient as an outpatient or in an alternative level of inpatient care.
(a)
(i) The patient, or if the patient is expected to be unable to comprehend the notice, the patient's next of kin, guardian or other representative or sponsor;
(ii) The attending physician, or other attending health care practitioner;
(iii) The facility; and
(iv) The fiscal intermediary or carrier.
(2)
(i) For admission, on the first working day after the initial denial determination;
(ii) For continued stay (e.g., outliers in facilities under a prospective payment system), by the first working day after the initial denial determination if the beneficiary is still in the facility, and within 3 working days if the beneficiary has been discharged;
(iii) For preprocedure review, before the procedure is performed;
(iv) For preadmission review, before admission;
(v) If identification as a Medicare program patient has been delayed, within three working days of identification;
(vi) For retrospective review, (excluding DRG validation and post procedure review), within 3 working days of the initial denial determination; and
(vii) For post-procedure review, within 3 working days of the initial denial determination.
(3)
(b)
(c)
(1) The reason for the initial denial determination or change as a result of the DRG validation;
(2) For day outliers in hospitals, the date on which the stay or services in the facility will not be approved as being reasonable and medically necessary or appropriate to the patients' health care needs;
(3) A statement informing each party or his or her representative of the right to request in accordance with the provisions of part 473, subpart B of this chapter—
(i) Review of a change resulting from DRG validation; or
(ii) Reconsideration of the initial denial determination;
(4) The locations for filing a request for reconsideration or review and the time period within which a request must be filed;
(5) A statement about who is liable for payment of the denied services under section 1879 of the Act; and
(6) A statement concerning the duties and functions of the QIO under the Act.
(d)
(e)
(2) The documentary record must include—
(i) The detailed basis for the initial denial determination or changes as a result of a DRG validation; and
(ii) A copy of the determination or change in DRG notices sent to all parties and identification of each party and the date on which the notice was mailed or delivered.
(a)
(1) Within one year of the date of the claim containing the service in question, may review and deny payment; and
(2) Within one year of the date of its decision, may reopen an initial denial determination or a change as a result of a DRG validation.
(b)
(2) A reopening of an initial denial determination or change as a result of a DRG validation may be made after one year but within four years of the date of the QIO's decision if—
(i) Additional information is received on the patient's condition;
(ii) Reviewer error occurred in interpretation or application of Medicare coverage policy or review criteria;
(iii) There is an error apparent on the face of the evidence upon which the initial denial or DRG validation was based; or
(iv) There is a clerical error in the statement of the initial denial determination or change as a result of a DRG validation.
(c)
(2) An initial denial determination or change as a result of a DRG validation may be reopened and revised anytime there is a finding that it was obtained through fraud or a similar abusive practice that does not support a finding of fraud.
(a)
(2) If a QIO determines that peers are not available to make initial denial determinations, a doctor of medicine or osteopathy may make denial determinations for services ordered or performed by a doctor in any of the three specialties.
(3) For purposes of paragraph (a)(1) of this section, individuals authorized to practice medicine in American Samoa, the Northern Mariana Islands, and the Trust Territory of the Pacific Islands as “medical officers” may make determinations on care ordered or furnished by their peers but not on care ordered or furnished by licensed doctors of medicine or osteopathy.
(b)
(c)
(d)
(i) Participated in developing or executing the beneficiary's treatment plan;
(ii) Is a member of the beneficiary's family; or
(iii) Is a governing body member, officer, partner, 5 percent or more owner, or managing employee in the health care facility where the services were or are to be furnished.
(2) A member of a reviewer's family is a spouse (other than a spouse who is legally separated under a decree of divorce or separate maintenance), child (including a legally adopted child), grandchild, parent, or grandparent.
(a)
(b)
(1) The necessity for facility admission and continued stay (in cases of day outliers in hospitals under prospective payment);
(2) The necessity for surgery and other invasive diagnostic and therapeutic procedures; or
(3) The appropriateness of providing services at a particular health care facility or at a particular level of care. The QIO must determine whether the beneficiary requires the level of care received or whether a lower and less costly level of care would be equally effective.
(c)
(1) Establish written criteria based upon typical patterns of practice in the QIO area, or use national criteria where appropriate; and
(2) Establish written criteria and standards to be used in conducting quality review studies.
(d)
(1) The patterns of practice in those locations and facilities are substantially different from patterns in the remainder of the QIO area; and
(2) There is a reasonable basis for the difference which makes the variation appropriate.
(a)
(1) Consult with the peers of the practitioners who furnish the services under review if the QIO reviews care and services delivered by health care practitioners other than physicians.
(2) Assure that in determinations regarding medical necessity of services or the quality of the services they furnish, these practitioners are involved in—
(i) Developing QIO criteria and standards;
(ii) Selecting norms to be used; and
(iii) Developing review mechanisms for care furnished by their peers.
(3) Ensure that an initial denial determination or a change as a result of DRG validation of services provided by a health care practitioner other than a physician is made by a physician only after consultation with a peer of that practitioner. Initial denial determinations and changes as a result of DRG validations must be made only by a physician or dentist.
(b)
(1) The QIO has been unable to obtain a roster of peer practitioners available to perform review; or
(2) The practitioners are precluded from performing review because they participated in the treatment of the patient, the patient is a relative, or the practitioners have a financial interest
(c)
(d)
In order to achieve efficient and economical review, a QIO must coordinate its activities (including information exchanges) with the activities of—
(a) Medicare fiscal intermediaries and carriers;
(b) Other QIOs; and
(c) Other public or private review organizations as may be appropriate.
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
This subpart establishes the requirements and procedures for—
(a) Reconsiderations conducted by a Utilization and Quality Control Quality Improvement Organization (QIO) or its subcontractor of initial denial determinations concerning services furnished or proposed to be furnished under Medicare;
(b) Hearings and judicial review of reconsidered determinations; and
(c) QIO review of a change in diagnostic and procedural coding information.
(a) Under section 1154 of the Act, a QIO may make an initial determination that services furnished or proposed to be furnished are not reasonable, necessary, or delivered in the most appropriate setting.
(b) Under section 1155 of the Act, the following rules apply:
(1) A Medicare beneficiary, a provider, or an attending practitioner who is dissatisfied with an initial denial determination under paragraph (a) of this section is entitled to a reconsideration by the QIO that made that determination.
(2) The beneficiary is also entitled to the following:
(i) A hearing by an administrative law judge if $200 or more is still in controversy after a reconsidered determination.
(ii) Judicial review if $2000 or more is still in controversy after a final determination by the Department.
(c) Under section 1866(a)(1)(F) of the Act, a hospital that is reimbursed by the Medicare program must maintain an agreement with a QIO under which the QIO reviews the validity of diagnostic information furnished by the hospital.
(a)
(1) Reasonableness of services.
(2) Medical necessity of services.
(3) Appropriateness of the inpatient setting in which services were furnished or are proposed to be furnished.
(b)
(c)
(2) Limitation of liability determinations on excluded coverage of certain services are made under section 1879 of the Act. Initial determinations under section 1879 and further appeals are governed by the reconsideration and appeal procedures in part 405, subpart G of this chapter for determinations under Medicare Part A, and part 405, subpart H of this chapter for determinations under Medicare Part B. References in those subparts to initial and reconsidered determinations made by an intermediary, carrier or CMS should be read to mean initial and reconsidered determinations made by a QIO.
(a)
(i) The change caused an assignment of a different DRG; and
(ii) Resulted in a lower payment.
(2) A beneficiary may obtain a review of a QIO DRG coding change only if that change results in noncoverage of a furnished service.
(3) The individual who reviews changes in DRG procedural or diagnostic information must be a physician, and the individual who reviews changes in DRG coding must be qualified through training and experience with ICD-9-CM coding.
(b)
(c)
A beneficiary, provider or practitioner who is dissatisfied with a QIO initial denial determination on one of the issues specified in § 473.14(a) has a right to a reconsideration of that determination by the QIO that made the initial denial determination.
(a)
(1) The QIO or the QIO subcontractor that made the initial determination.
(2) An SSA District Office.
(3) A Railroad Retirement Board Office, if the beneficiary is a railroad retiree.
(b)
(c)
(a)
(2) The date of receipt of the notice of the initial determination is presumed to be five days after the date on the notice, unless there is a reasonable showing to the contrary.
(3) A request is considered filed on the date it is postmarked.
(b)
(c)
(a)
(1) What circumstances kept the party from making the request on time.
(2) Whether an action by the QIO misled the party.
(3) Whether the party understood the requirements of the Act as affected by amendments to the Act, other legislation, or court decisions.
(b)
(1) A party was seriously ill and was prevented from requesting a reconsideration in person, through another person, or in writing.
(2) There was a death or serious illness in a party's immediate family.
(3) Important records were accidentally destroyed or damaged by fire or other cause.
(4) A party made a diligent effort but could not find or obtain necessary relevent information within the appropriate time period.
(5) A party requested additional information to further explain the determination within the time limit, and requested reconsideration within 60 days of receiving the explanation (or within 30 days for a Departmental Appeals Board hearing).
(6) The QIO gave the party incorrect or incomplete information about when and how to request a reconsideration or hearing.
(7) A party sent the request to another Government agency in good faith within the time limit, but the request did not reach an office authorized to receive the request until after the time period had expired.
(8) Other unusual or unavoidable circumstances exist that—
(i) Show that a party could not have known of the need to file timely; or
(ii) Prevented a party from filing timely.
(a) Subject to the rules concerning disclosure of QIO information in section 1160 of the Act, at the request of a provider, practitioner or beneficiary,
(1) A record of the QIO deliberation; or
(2) The identity of the QIO review coordinators, physician advisors, or consultants who assisted in the initial denial determination without their consent.
(b) The QIO may require the requester to pay a reasonable fee for the reproduction of the material requested.
(c) The QIO must provide a party with an opportunity to submit new evidence before the reconsidered determination is made.
A QIO may delegate the authority to reconsider an initial determination to a nonfacility subcontractor, including the organization that made the initial determination as a QIO subcontractor.
A reconsideration reviewer must be someone who is—
(a) Qualified under § 466.98 of this chapter to make an initial determination.
(b) Not the individual who made the initial denial determination.
(c) A specialist in the type of services under review, except where meeting this requirement would compromise the effectiveness or efficiency of QIO review.
A reconsidered determination must be based on—
(a) The information that led to the initial determination;
(b) New information found in the medical records; or
(c) Additional evidence submitted by a party.
(a)
(1) Within three working days after the QIO receives the request for reconsideration if—
(i) The beneficiary is still an inpatient in a hospital for the stay in question when the QIO receives the request for reconsideration; or
(ii) The initial determination relates to institutional services for which admission to the institution is sought, the initial determination was made before the patient was admitted to the institution; and a request was submitted timely for an expedited reconsideration.
(2) Within 10 working days after the QIO receives the request for reconsideration if the beneficiary is still an inpatient in a SNF for the stay in question when the QIO receives the request for reconsideration.
(3) Within 30 working days after the QIO receives the request for reconsideration if—
(i) The initial determination concerns ambulatory or noninstitutional services;
(ii) The beneficiary is no longer an inpatient in a hospital or SNF for the stay in question; or
(iii) The beneficiary does not submit a request for expedited reconsideration timely.
(b)
(a)
(1) The basis for the reconsidered determination.
(2) A detailed rationale for the reconsidered determination.
(3) A statement explaining the Medicare payment consequences of the reconsidered determination.
(4) A statement informing the parties of their appeal rights, including the information concerning what must be included in the request for hearing, the amount in controversy, locations for submitting a request for an administrative hearing and the time period for filing a request.
(b)
(2) This notice must contain adequate information to allow the intermediary or carrier to locate the claim file. This must include the name of the beneficiary, the Health Insurance Claim Number, the name of the provider, date of admission, and dates or services for which Medicare payment will not be made.
(a)
(1) Four years after the date on the notice of the QIO's reconsidered determination.
(2) Completion of litigation and the passage of the time period for filing all appeals.
(b)
(1) The initial determination.
(2) The basis for the initial determination.
(3) Documentation of the date of the receipt of the request for reconsideration.
(4) The detailed basis for the reconsidered determination.
(5) Evidence submitted by the parties.
(6) A copy of the notice of the reconsidered determination that was provided to the parties.
(7) Documentation of the delivery or mailing and, if appropriate, the receipt of the notice of the reconsidered determination by the parties.
(c)
A QIO reconsidered determination is binding upon all parties to the reconsideration unless—
(a) A hearing is requested in accordance with § 473.40 and a final decision rendered; or
(b) The reconsidered determination is later reopened and revised in accordance with § 473.48.
(a)
(b)
(1) Reasonableness of the services.
(2) Medical necessity of the services.
(3) Appropriateness of the setting in which the services were furnished.
(c)
(a)
(1) The office of the QIO or QIO subcontractor that made the initial determination.
(2) A SSA District Office.
(3) An office of the Office of Hearings and Appeals of SSA.
(4) An office of the Railroad Retirement Board, in the case of a beneficiary who is a railroad retiree.
(b)
(2) The date of receipt of the notice of the reconsidered determination is presumed to be five days after the date on the notice, unless there is a reasonable showing to the contrary.
(3) A request is considered filed on the date it is postmarked.
(a) After an individual appellant has submitted a request for a hearing, the ALJ determines the amount in controversy in accordance with § 405.740(a) of this chapter for Part A services or § 405.817(a) of this chapter for Part B services. When two or more appellants submit a request for hearing, the ALJ determines the amount in controversy in accordance with § 405.740(b) of this chapter for Part A services and § 405.817(b) of this chapter for Part B services.
(b) If the ALJ determines that the amount in controversy is less than $200, the ALJ, without holding a hearing, notifies the parties to the hearing that the parties have 15 calendar days to submit additional evidence to prove that the amount in controversy is at least $200.
(c) At the end of the 15-day period, if the ALJ determines that the amount in controversy is less than $200, the ALJ, without holding a hearing, dismisses the request for a hearing without ruling on the substantive issues involved in the appeal and notifies the parties to the hearing and the QIO that the QIO reconsidered determination is conclusive for Medicare payment purposes.
(a) The circumstances under which the DAB will review an ALJ hearing decision or dismissal are the same as those set forth at 20 CFR 404.970, (“Cases the Appeals Council will review”).
(b) If $2,000 or more is in controversy, a party may obtain judicial review of an Departmental Appeals Board decision, or an ALJ hearing decision if a request for review by the Departmental Appeals Board was denied, by filing a civil action under the Federal Rules of Civil Procedure within 60 days after the date the party received notice of the Departmental Appeals Board decision or denial.
(a)
(2)
(i) The QIO receives new material evidence;
(ii) The QIO erred in interpretation or application of Medicare coverage policy;
(iii) There is an error apparent on the face of the evidence upon which the reconsidered determination was based; or
(iv) There is a clerical error in the statement of the reconsidered determination.
(b)
(c)
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
(a)
(1) Disclosure of information collected, acquired or generated by a Utilization and Quality Control Quality Improvement Organization (QIO) (or the review component of a QIO subcontractor) in performance of its responsibilities under the Act and these regulations; and
(2) Acquisition and maintenance of information by a QIO to comply with its responsibilities under the Act.
(b)
(1) Information that explicitly or implicitly identifies an individual patient, practitioner or reviewer.
(2) Sanction reports and recommendations.
(3) Quality review studies which identify patients, practitioners or institutions.
(4) QIO deliberations.
(1) The QIO and its officers, members and employees;
(2) QIO subcontractors;
(3) Health care institutions and practitioners whose services are reviewed;
(4) QIO reviewers and supporting staff; and
(5) Data support organizations.
(a) Section 1154(a)(7)(C) of the Act requires QIOs to the extent necessary and appropriate to examine the pertinent records of any practitioner or provider of health care services for which payment may be made under Title XVIII of the Act.
(b) Section 1154(a)(9) of the Act requires QIOs to collect and maintain information necessary to carry out their responsibilities under the Act.
(c) Section 1156(a)(3) of the Act requires health care practitioners and providers to maintain evidence of the medical necessity and quality of health care services they provide to Medicare patients as required by QIOs.
(a) Section 1154(a)(10) of the Act requires QIOs to exchange information with intermediaries and carriers with contracts under sections 1816 and 1842 of the Act, other QIOs, and other public or private review organizations as appropriate.
(b) Section 1160 of the Act provides that QIO information must be held in confidence and not be disclosed except where—
(1) Necessary to carry out the purpose of Title XI Part B of the Act;
(2) Specifically permitted or required under this subpart;
(3) Necessary, and in the manner prescribed under this subpart, to assist Federal and State agencies recognized by the Secretary as having responsibility for identifying and investigating cases or patterns of fraud or abuse;
(4) Necessary, and in the manner prescribed under the subpart to assist Federal or State agencies recognized by the Secretary as having responsibility for identifying cases or patterns involving risks to the public health;
(5) Necessary, and in the manner prescribed under this subpart, to assist appropriate State agencies having responsibility for licensing or certification of providers or practitioners; or
(6) Necessary, and in the manner prescribed under this subpart to assist Federal or State health planning agencies by furnishing them aggregate statistical data on a geographical, institutional or other basis.
(a)
(2) Disclosure of confidential information made under the authority of this subpart, except as provided in § 480.106, must be accompanied by a written statement informing the recipient that the information may not be redisclosed except as provided under § 480.107 that limits redisclosure.
(b)
(c)
(d)
(e)
(a)
(b)
(2) A QIO must notify a practitioner or institution of the QIO's intent to disclose information on the practitioner or institution to an investigative or licensing agency (§§ 480.137 and 480.138) except for cases specified in § 480.106 involving fraud or abuse or imminent danger to individuals or the public health. The practitioner or institution must be notified and provided a copy of the information to be disclosed at least 30 calendar days before the QIO discloses the identifying information. The QIO must forward with the information any comments submitted by the practitioner or institution in response to the QIO notice if received before disclosure, or forwarded separately if received after disclosure.
(a)
(b)
(1) The disclosure is made in an investigation of fraud or abuse by the Office of the Inspector General or the General Accounting Office; or
(2) The disclosure is made in an investigation of fraud or abuse by any other Federal or State fraud or abuse agency and the investigative agency specifies in writing that the information is related to a potentially prosecutable criminal offense.
(c)
(1) The institution or practitioner has requested, in writing, that the QIO make the disclosure;
(2) The institution or practitioner has provided, in writing, consent for the disclosure; or
(3) The information is public information as defined in § 480.101(b) and specified under § 480.120.
Persons or organizations that obtain confidential QIO information must not further disclose the information to any other person or organization except—
(a) As directed by the QIO to carry out a disclosure permitted or required under a particular provision of this part;
(b) As directed by CMS to carry out specific responsibilities of the Secretary under the Act;
(c) As necessary for CMS to carry out its responsibilities for appeals under section 1155 of the Act or for CMS to process sanctions under section 1156 of the Act;
(d) If the health care services furnished to an individual patient are reimbursed from more than one source, these sources of reimbursement may exchange confidential information as necessary for the payment of claims;
(e) If the information is acquired by the QIO from another source and the receiver of the information is authorized under its own authorities to acquire the information directly from the source, the receiver may disclose the information in accordance with the source's redisclosure rules;
(f) As necessary for the General Accounting Office to carry out its statutory responsibilities;
(g) Information pertaining to a patient or practitioner may be disclosed by that individual provided it does not identify any other patient or practitioner;
(h) An institution may disclose information pertaining to itself provided it does not identify an individual patient or practitioner;
(i) Governmental fraud or abuse agencies and State licensing or certification agencies recognized by CMS may disclose information as necessary in a judicial, administrative or other formal legal proceeding resulting from an investigation conducted by the agency;
(j) State and local public health officials to carry out their responsibilities, as necessary, to protect against a substantial risk to the public health; or
(k) As necessary for the Office of the Inspector General to carry out its statutory responsibilities.
A person who discloses information not authorized under Title XI Part B of the Act or the regulations of this part will, upon conviction, be fined no more than $1,000, or be imprisoned for no more than six months, or both, and will pay the costs of prosecution.
The provisions of 42 U.S.C. 290dd-3 and 290ee-3 governing confidentiality of alcohol and drug abuse patients' records, and the implementing regulations at 42 CFR part 2, are applicable to QIO information.
(a) A QIO is authorized to have access to and obtain records and information pertinent to the health care services furnished to Medicare patients, held by any institution or practitioner in the QIO area. The QIO may require the institution or practitioner to provide copies of such records or information to the QIO.
(b) A QIO may obtain non-Medicare patient records relating to review performed under a non-Medicare QIO contract if authorized by those patients in accordance with State law.
(c) In accordance with its quality review responsibilities under the Act, a QIO may have access to and obtain information from, the records of non-Medicare patients if authorized by the institution or practitioner.
(d) A QIO may reimburse for requested information at the rate of $.10 per page for photocopying plus first class postage. The photocopying amount includes the cost of labor, supplies, equipment, and overhead.
A QIO is authorized to have access to and require copies of Medicare records or information held by intermediaries or carriers if the QIO determines that
(a) Institutions and other entities must disclose to the QIO information collected by them for QIO purposes.
(b) Information collected or generated by institutions or practitioners to carry out quality review studies must be disclosed to the QIO.
A QIO or any agent, organization, or institution acting on its behalf, that is collecting information under authority of this part, must collect only that information which is necessary to accomplish the purposes of Title XI Part B of the Act in accordance with 44 U.S.C. Chapter 35, Coordination of Federal Reporting Services Information Policy.
(a)
(b)
(c)
(d)
(1) Has completed a training program in the handling of QIO information in accordance with paragraph (c) of this section or has received comparable training from another source; and
(2) Has signed a statement indicating that he or she is aware of the legal penalties for unauthorized disclosure.
(e)
(2) The QIO must destroy or return to the facility from which it was collected confidential information generated from computerized information, patient records and other noncomputerized files when the QIO determines that the maintenance of hard copy is no longer necessary to serve the specific purpose for which it was obtained or generated.
(f)
The QIO must establish and implement procedures to provide patients, practitioners, and institutions under review with the following information—
(a) The title and address of the person responsible for maintenance of QIO information;
(b) The types of information that will be collected and maintained;
(c) The general rules governing disclosure of QIO information; and
(d) The procedures whereby patients, practitioners, and institutions may obtain access to information about themselves.
Subject to the procedures for disclosure and notice of disclosure specified in §§ 480.104 and 480.105, the QIO must disclose—
(a) Nonconfidential information to any person upon request, including—
(1) The norms, criteria, and standards it uses for initial screening of cases, and for other review activities;
(2) Winning technical proposals for contracts from the Department, and winning technical proposals for subcontracts under those contracts (except for proprietary or business information);
(3) Copies of documents describing administrative procedures, agreed to between the QIO and institutions or between a QIO and the Medicare intermediary or Medicare carrier;
(4) Routine reports submitted by the QIO to CMS to the extent that they do not contain confidential information.
(5) Summaries of the proceedings of QIO regular and other meetings of the governing body and general membership except for those portions of the summaries involving QIO deliberations, which are confidential information and subject to the provisions of § 480.139;
(6) Public information in its possession;
(7) Aggregate statiscal information that does not implicitly or explicitly identify individual patients, practitioners or reviewers;
(8) Quality review study information including summaries and conclusions from which the identification of patients, practitioners and institutions has been deleted; and
(9) Information describing the characteristics of a quality review study, including a study design and methodology.
(b) Aggregate statistical information that does not implicitly or explicitly identify individual patients, practitioners or reviewers, to Federal or State health planning agencies (including Health Systems Agencies and State Health Planning and Development Agencies) in carrying out their health care planning and related activities.
A QIO may, on its own initiative, subject to the notification requirements in § 480.105, furnish the information available under § 480.120 to any person, agency, or organization.
Except as limited by §§ 480.139(a) and 480.140 of this subpart, QIOs must disclose all information requested by the Department to it in the manner and form required.
CMS or any person, organization or agency authorized by the Department or Federal statute to monitor a QIO will have access to medical records maintained by institutions or health care practitioners on Medicare patients. The monitor can require copies of the records.
(a)
(1) Disclose patient identified information in its possession to the identified patient or the patient's representative if—
(i) The patient or the patient's representative requests the information in writing;
(ii) The request by a patient's representative includes the designation, by the patient, of the representative; and
(iii) All other patient and practitioner identifiers have been removed.
(2) Seek the advice of the attending practitioner that treated the patient regarding the appropriateness of direct disclosure to the patient 15 days before the QIO provides the requested information. If the attending practitioner states that the released information could harm the patient, the QIO must act in accordance with paragraph (c)(2) of this section. The QIO must make disclosure to the patient or patient's representative within 30 calendar days of receipt of the request.
(b)
(i) Need not seek the advice of the practitioner that treated the patient regarding the appropriateness of direct disclosure to the patient; and
(ii) Must provide only the information used to support that determination in accordance with the procedures for disclosure of information relating to determinations under § 473.24.
(2) A QIO must disclose information regarding QIO deliberations only as specified in § 480.139(a).
(3) A QIO must disclose quality review study information only as specified in § 480.140.
(c)
(2) If knowledge of the information could harm the patient, the QIO must disclose the information to the patient's designated representative.
(3) If the patient is mentally, physically or legally unable to designate a representative, the QIO must disclose the information to a person whom the QIO determines is responsible for the patient.
(a)
(1)
(2)
(ii) In accordance with section 1160 of the Act, a QIO must disclose information that displays practice or performance patterns of a practitioner or institution in accordance with the procedures for disclosures specified in §§ 480.137 and 480.138 to—
(A) Federal and State agencies that are responsible for the investigation of fraud and abuse of the Medicare or Medicaid programs, and
(B) Federal and State agencies that are responsible for licensing and certification of practitioners and providers.
(iii) A QIO may disclose to any person, agency, or organization information on a particular practitioner or reviewer at the written request of or with the written consent of that practitioner or reviewer. The recipient of the information has the same redisclosure rights and responsibilities as the requesting or consenting practitioner or reviewer as provided under this Subpart B.
(b)
(2) A QIO must disclose information regarding QIO deliberations only as specified in § 480.139(a).
(3) A QIO must disclose quality review study information only as specified in § 480.140.
(a) A QIO must verify the accuracy of its information concerning patients, practitioners, reviewers, and institutions and must permit the individual or institution to request an amendment of pertinent information that is in the possession of the QIO.
(b) If the QIO agrees with the request for amendment, the QIO must correct the information in its possession. If the information being amended has already been disclosed, the QIO must forward the amended information to the requester where it may affect decisions about a particular provider, practitioner or case under review.
(c) If the QIO disagrees with the request for amendment, a notation of the request, reasons for the request, and the reasons for refusal must be included with the information and attached to any disclosure of the information.
(a)
(b)
(c)
(1) To another QIO, information on patients and practitioners who are subject to review by the other QIO; and
(2) To medical review boards established under section 1881 of the Act, confidential information on patients, practitioners and institutions receiving or furnishing end stage renal disease services.
(a)
(1) Review determinations and claims forms for health care services, furnished in the manner and form agreed to by the QIO and the intermediary or carrier.
(2) Upon request, copies of medical records acquired from practitioners or institutions for review purposes.
(3) QIO information about a particular patient or practitioner if the QIO and the intermediary or carrier (or CMS if the QIO and the intermediary or carrier cannot agree) determine that the information is necessary for the administration of the Medicare program.
(b)
(a)
(1) Identifies the name and title of the individual initiating the request,
(2) Identifies the physician or institution about which information is requested, and
(3) States affirmatively that the institution or practitioner is currently under investigation for fraud or abuse of the Medicare or Medicaid programs and that the information is needed in furtherance of that investigation.
(b)
(a)
(1)
(ii) A QIO may provide the information specified in paragraph (a)(1)(i) of this section to the State or Federal licensing body without request.
(2)
(3)
(b)
(2) A QIO must disclose information regarding QIO deliberations and quality review study information only as specified in §§ 480.139(a) and 480.140.
(a)
(i) CMS, at the QIO office or at a subcontracted organization;
(ii) CMS, to the extent that the deliberations are incorporated in sanction and appeals reports; or
(iii) The Office of the Inspector General, and the General Accounting Office as necessary to carry out statutory responsibilities.
(2) QIO deliberations are not disclosable, either in written form or through oral testimony, in connection with the administrative hearing or review of a beneficiary's claim.
(b)
(2) A QIO must disclose, if requested in connection with the administrative hearing or review of a beneficiary's claim, the reasons for QIO decisions. The QIO must include the detailed facts, findings and conclusions supporting the QIO's determination. The QIO must insure that the opinions or judgements of a particular individual or practitioner cannot be identified through the materials that are disclosed.
(a) A QIO must disclose, onsite, quality review study information with identifiers of patients, practitioners or institutions to—
(1) Representatives of authorized licensure, accreditation or certification agencies as is required by the agencies in carrying out functions which are within the jurisdiction of such agencies under state law; to federal and state agencies responsible for identifying risks to the public health when there is substantial risk to the public health; CMS; or to Federal and State fraud and abuse enforcement agencies;
(2) An institution or practitioner, if the information is limited to health care services furnished by the institution or practitioner; and
(3) A medical review board established under section 1881 of the Act pertaining to end-stage renal disease facilities, if the information is limited to health care services subject to its review.
(b) A QIO must disclose quality review study information with identifiers of patients, practitioners or institutions to the Office of the Inspector General and the General Accounting Office as necessary to carry out statutory responsibilities.
(c) A QIO may disclose information offsite from a particular quality review study to any institution or practitioner involved in that study, provided the disclosed information is limited to that institution or practitioner.
(d) A QIO may disclose quality review study information with identifiers of particular practitioners or institutions, or both, at the written request of, or with the written consent of, the identified practitioner(s) or institution(s).
(1) The consent or request must specify the information that is to be disclosed and the intended recipient of the information.
(2) The recipient of the information has the same redisclosure rights and responsibilities as the requesting or consenting practitioner or institution as provided under this Subpart B.
(e) An institution or group of practitioners may redisclose quality review study information, if the information is limited to health care services they provided.
(f) Quality review study information with patient identifiers is not subject to subpoena or discovery in a civil action, including an administrative, judicial or arbitration proceeding. This restriction does not apply to HHS, including Inspector General, administrative subpoenas issued in the course of audits and investigations of Department programs, in the course of administrative hearings held under the Social Security Act, or to disclosures to the General Accounting Office as necessary to carry out its statutory responsibilities.
Subject to the procedures for disclosure and notice of disclosure specified in §§ 480.104 and 480.105, a QIO may disclose to the public QIO interpretations and generalizations on the quality of health care that identify a particular institution.
(a) The QIO must disclose sanction reports directly to the Office of the Inspector General and, if requested, to CMS.
(b) The QIO must upon request, and may without a request, disclose sanction reports to State and Federal agencies responsible for the identification, investigation or prosecution of cases of fraud or abuse in accordance with § 480.137.
(c) CMS will disclose sanction determinations in accordance with part 474 of this chapter.
(a)
(b)
(c)
(1) The source from which the QIO acquired the information consents to or requests disclosure; or
(2) The QIO requests the disclosure of the information to carry out a disclosure permitted under a provision of this part.
A list of CFR titles, subtitles, chapters, subchapters and parts and an alphabetical list of agencies publishing in the CFR are included in the CFR Index and Finding Aids volume to the Code of Federal Regulations which is published separately and revised annually.
Table of CFR Titles and Chapters
Alphabetical List of Agencies Appearing in the CFR
Table of OMB Control Numbers
List of CFR Sections Affected
The OMB control numbers for chapter IV of title 42 appear in § 400.310. Sections 400.300 and 400.310 are reprinted below for the convenience of the user.
This subpart collects and displays control numbers assigned by the Office of Management and Budget (OMB) to collections of information contained in CMS regulations, in accordance with OMB's regulations for controlling paperwork burdens on the public, 5 CFR part 1320. CMS intends that the subpart comply with the requirements of section 3507(f) of the Paperwork Reduction Act of 1980, 44 U.S.C. chapter 35 which requires that agencies shall not engage in a “collection of information” without obtaining a control number from OMB.
All changes in this volume of the Code of Federal Regulations that were made by documents published in the
For the period before January 1, 2001, see the “List of CFR Sections Affected, 1949-1963, 1964-1972, 1973-1985, and 1986-2000” published in 11 separate volumes.