Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
For purposes of this part:
(1) Beneficiary complaint reviews;
(2) General quality of care reviews;
(3) Emergency Medical Treatment and Labor Act (EMTALA) reviews;
(4) Medical necessity reviews, including appeals and DRG validation reviews; and
(5) Admission and discharge reviews.
(1) Has an ownership interest of 5 percent or more;
(2) Has an indirect ownership interest equal to 5 percent or more;
(3) 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
(4) 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, a doctor of dental surgery or dental medicine, a doctor of podiatry, a doctor of optometry, or a chiropractor as described in section 1861(r) of the Act;
(2) An intern, resident, or Federal Government employee authorized under State or Federal law to practice as a doctor as described in paragraph (1) of this definition; and
(3) An individual licensed to practice as a doctor as described in paragraph (1) of this definition in any Territory or Commonwealth of the United States of America.
This subpart implements sections 1152 and 1153(b) and (c) of the Social Security Act as amended by section 261 of the Trade Adjustment Assistance Extension Act of 2011. This subpart defines the types of organizations that are eligible to become Quality Improvement Organizations (QIOs) and describes certain steps CMS will take in selecting QIOs.
In order to be eligible for a QIO contract, an organization must meet the following requirements:
(a) Have a governing body that includes at least one individual who is a representative of health care providers and at least one individual who is a representative of consumers.
(b) Demonstrate the ability to perform the functions of a QIO, including—
(1) The ability to meet the eligibility requirements and perform activities as set forth in the QIO Request for Proposal; and
(2) The ability to—
(i) Perform case reviews as described in § 475.102; and/or
(ii) Perform quality improvement initiatives as set forth in § 475.103.
(c) Demonstrate the ability to actively engage beneficiaries, families, and consumers, as applicable, in case reviews as set forth in § 475.102, and/or quality improvement initiatives as set forth in § 475.103.
(d) Demonstrate the ability to perform the functions of a QIO with objectivity and impartiality and in a fair and neutral manner.
(a) In determining whether or not an organization has demonstrated the ability to perform case review, CMS will take into consideration factors such as:
(1) The organization's proposed processes, capabilities, quantitative, and/or qualitative performance objectives and methodology to perform case reviews;
(2) The organization's proposed involvement of and access to physicians and practitioners in the QIO area with the appropriate expertise and specialization in the areas of health care related to case reviews;
(3) The organization's ability to take into consideration urban versus rural, local, and regional characteristics in the health care setting where the care under review was provided;
(4) The organization's ability to take into consideration evidence-based national clinical guidelines and professionally recognized standards of care; and
(5) The organization's access to qualified information technology (IT) expertise.
(b) In making determinations under this section, CMS may consider characteristics such as the organization's geographic location and size. CMS may also consider prior experience in health care quality improvement that CMS considers relevant to performing case reviews; such prior experience may include prior similar case review experience.
(c) A State government that administers a Medicaid program will be considered incapable of performing case
(a) In determining whether or not an organization has demonstrated the ability to perform quality improvement initiatives, CMS will take into consideration factors such as:
(1) The organization's proposed processes, capabilities, quantitative, and/or qualitative performance objectives, and methodology to perform quality improvement initiatives;
(2) The organization's proposed involvement of and access to physicians and practitioners in the QIO area with the appropriate expertise and specialization in the areas of health care concerning the quality improvement initiatives;
(3) The organization's access to professionals with appropriate knowledge of quality improvement methodologies and practices; and
(4) The organization's access to qualified information technology (IT) expertise.
(b) In making determinations under this section, CMS may consider characteristics such as the organization's geographic location and size. CMS may also consider prior experience in health care quality improvement that CMS considers relevant to performing quality improvement initiatives; such prior experience may include prior similar quality improvement initiative experience and whether it achieved successful results.
(c) A State government that administers a Medicaid program will be considered incapable of performing quality improvement initiative functions in an effective manner, unless the State demonstrates to the satisfaction of CMS that the State agency performing the quality improvement initiatives will act with complete objectivity and independence from the Medicaid program.
(a)
(1) A health care facility in the QIO area.
(2) 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 in the QIO area.
(3) A payor organization, unless the Secretary determines that—
(i) There is no other entity available for an area with which the Secretary can enter into a contract under this part; or
(ii) A payor organization is a more qualified entity to perform one or more of the functions of a QIO described in § 475.101(b), meets all other requirements and standards of this part, and demonstrates to the satisfaction of CMS that, in performing QIO activities, the payor organization will act with complete objectivity and independence from its payor program.
(b) [Reserved]
(c)
Subject to the provisions of § 475.105, CMS will—
(a) Ensure that all awardees meet the requirements of §§ 475.101 through 475.103, as applicable; and
(b) Award the contract to the selected organization for a specific QIO area for a period of 5 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:
(1) Has an ownership interest of 5 percent or more;
(2) Has an indirect ownership interest equal to 5 percent or more;
(3) 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
(4) 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.
(1) A doctor or medicine or osteopathy, a doctor of dental surgery or dental medicine, a doctor of podiatry, a doctor of optometry, or a chiropractor, as described in section 1861(r) of the Act;
(2) An intern, resident, or Federal Government employee authorized under State or Federal law to practice as a doctor as described in paragraph (1) of this definition; and
(3) An individual licensed to practice as a doctor as described in paragraph (1) of this definition in any Territory or Commonwealth of the United States of America.
(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, as determined through the resolution of oral beneficiary complaints as specified in § 476.110, written beneficiary complaints as specified in § 476.120, or the completion of general quality of care reviews as specified in § 476.160.
(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)
(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 § 476.78(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
(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 administrative contractor, 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 administrative contractors, 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 § 411.402 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 § 476.71.
(b)
(1) Providers must allocate adequate space to the QIO for its conduct of review at the times the QIO is conducting review.
(2) Providers and practitioners must 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. When the QIO does postadmission, preprocedure review, the provider must provide the necessary information before the procedure is performed, unless it must be performed on an emergency basis. Providers and practitioners must—
(i) Except as provided under §§ 476.130(b) and 476.160(b), relating to beneficiary complaint reviews and general quality of care reviews, photocopy and deliver to the QIO all required information within 14 calendar days of a request. A QIO is authorized to require the receipt of the medical information earlier than the 14-day timeframe if the QIO makes a preliminary determination that the review involves a potential gross and flagrant or substantial violation as specified in part 1004
(ii) Send secure transmission of an electronic version of medical information, if available, subject to the QIO's ability to support receipt and transmission of the electronic version. Providers and practitioners must deliver electronic versions of medical information within 14 calendar days of the request. A QIO is authorized to require the receipt of the medical information earlier than the 14-day timeframe if the QIO makes a preliminary determination that the review involves a potential gross and flagrant or substantial violation as specified in part 1004 of this title and circumstances warrant earlier receipt of the medical information. A practitioner's or provider's failure to comply with the request for medical information within the established timeframe may result in the QIO taking action in accordance with § 476.90.
(3) Providers must 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 § 411.402(a) of this chapter, that can support a finding that the beneficiary knew the services were not covered.
(4) When the provider has issued a written determination in accordance with § 412.42(c)(3) of this chapter that a beneficiary no longer requires inpatient hospital care, it must submit a copy of its determination to the QIO within 3 working days.
(5) Providers must assure, in accordance with the provisions of their agreements 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) Providers must 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 provider, 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) Hospitals must 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 Medicare administrative contractor, 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 Medicare administrative contractor, fiscal intermediary, or carrier and obtain approval from CMS, before it makes conclusive determinations for the Medicare program, unless CMS finds that the Medicare administrative contractor, 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 administrative contractors, 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 Medicare administrative contractor, fiscal intermediary, or carrier to revise its agreements or procedures.
(d)
(1) Through a revised agreement with the Medicare administrative contractor, fiscal intermediary, or carrier, or
(2) In the case of procedures, by the QIO, after providing opportunity for comment by the Medicare administrative contractor, fiscal intermediary, or carrier.
(e)
(2) A QIO's determination that an admission is medically necessary is not a guarantee of payment by the Medicare administrative contractor or 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 performed in the manner and to the extent otherwise provided for under the Act or in regulations.
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 § 411.15(g) or § 411.15(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 administrative contractors, fiscal intermediaries, and 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 Medicare administrative contractor, fiscal intermediary, or carrier must use a QIO to make a determination on those issues if a QIO is conducting review in the area and must abide by the QIO's determination.
(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 provider 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 provider or practitioner has failed to comply with the requirements of 42 CFR 1004.10(c) 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 provider or practitioner, and may report the matter to the HHS Inspector General.
(b) If a QIO gives a provider or practitioner sufficient notice and a reasonable amount of time to respond to a request for information about a claim, and if the provider or practitioner does not respond in a timely manner, the QIO will deny the claim. A provider or practitioner may request that the QIO reconsider its decision to deny the claim. No further appeal rights are available.
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 Medicare administrative contractor, 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 478, 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 in the health care facility as described in § 466.98(d).
(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 administrative contractors, fiscal intermediaries, and carriers.
(b) Other QIOs; and
(c) Other public or private review organizations as may be appropriate.
(a)
(1) The complaint is received not later than 6 months from the date on which the care giving rise to the complaint occurred.
(2) After initial screening of the complaint, the QIO makes a preliminary determination that—
(i) The complaint is unrelated to the clinical quality of health care itself but relates to items or services that accompany or are incidental to the medical care and are provided by a practitioner and/or provider; or
(ii) The complaint, while related to the clinical quality of health care received by the beneficiary, does not rise to the level of being a gross and flagrant, substantial, or significant quality of care concern.
(3) The beneficiary agrees to the disclosure of his or her name to the involved provider and/or practitioner.
(4) All parties orally consent to the use of immediate advocacy.
(5) All parties agree to the limitations on redisclosure set forth in § 480.107 of this subchapter.
(b)
(1) The QIO must inform the parties that immediate advocacy will be discontinued; and
(2) The beneficiary must be informed of his or her right to submit a written complaint in accordance with the procedures in § 476.120.
(c)
(d)
(1) Inform the parties that immediate advocacy will be discontinued; and
(2) Inform the Medicare beneficiary of his or her right to submit a written complaint in accordance with the procedures in § 476.120.
(a)
(1) A written complaint includes a complaint submitted electronically to the QIO.
(2) In those instances where a Medicare beneficiary contacts the QIO regarding a complaint but declines to submit the complaint in writing and immediate advocacy has not been offered, the QIO may complete a general quality of care review in accordance with § 476.160 if the QIO makes a preliminary determination that the complaint involves a potential gross and flagrant, substantial or significant quality of care concern.
(b)
(a)
(1) The QIO's review will focus on the episode of care from which the complaint arose and address the specific concerns identified by the beneficiary and any additional concerns identified by the QIO. The QIO may separate concerns into different complaints if the QIO determine that the concerns relate to different episodes of care.
(2) The QIO will use evidence-based standards of care to the maximum extent practicable. If no standard of care exists, the QIO will use available norms, best practices and established guidelines to establish the standard that will be used in completing the review. The QIO's determination regarding the standard used is not subject to appeal.
(b)
(2) In requesting medical information in response to a Medicare beneficiary complaint, the QIO must notify the practitioner and/or provider that the medical record is being requested in response to a beneficiary complaint, explain the practitioner's and/or provider's right to discuss the QIO's interim initial determination, and request the name of a contact person in order to ensure timely completion of the discussion.
(c)
(1) A practitioner and provider will be notified by telephone of the opportunity to discuss the QIO's interim initial determination with the QIO in those situations where the peer reviewer determines that the quality of services does not meet professionally recognized standards of care for any concern in the complaint. The discussion must be held no later than 7 calendar days from the date of the initial offer.
(2) The interim initial determination becomes the final initial determination if the discussion is not completed timely as a result of the practitioner's and/or provider's failure to respond.
(3) Written statements in lieu of a discussion must be received no later than 7 calendar days from the date of the initial offer.
(4) In rare circumstances, the QIO may grant additional time to complete the discussion or submission of a written statement in lieu of a discussion.
(d)
(1) No later than 3 business days after completion of its review, or for cases in which the standard was not met, no later than 3 business days after the discussion or receipt of the provider's and/or practitioner's written statement, the QIO will notify (by telephone) the beneficiary and the provider/practitioner of its final initial determination and of the right to request a reconsideration of the QIO's final initial determination.
(2) Written notice of the QIO's final initial determination will be forwarded to all parties within 5 calendar days after completion of its review, and must include:
(i) A statement for each concern that care did or did not meet the standard of care;
(ii) The standard identified by the QIO for each of the concerns; and
(iii) A summary of the specific facts that the QIO determines are pertinent to its findings, including references to medical information and, if held, the discussion with the involved practitioner and/or provider.
(a)
(1) The reconsideration request must be received by the QIO, in writing or by telephone, no later than 3 calendar days following initial notification of the QIO's determination. If the QIO is unable to accept a request, the request must be submitted by noon of the next day the QIO is available to accept a request.
(2) The Medicare beneficiary, or his or her representative, and the practitioner and/or provider must be available to answer any questions or supply any information that the QIO requests in order to conduct its reconsideration.
(3) The QIO must offer the Medicare beneficiary and the practitioner and/or
(b)
(1) The QIO's initial notification may be done by telephone, followed by the mailing of a written notice by noon of the next calendar day that includes—
(i) A statement for each concern that care did or did not meet the standard of care;
(ii) The standard identified by the QIO for each of the concerns;
(iii) A summary of the specific facts that the QIO determines are pertinent to its findings; and
(iv) A statement that the letter represents the QIO's final determination and that there is no right to further appeal.
(2) The QIO may provide information to the beneficiary, practitioner, and provider regarding opportunities for improving the care given to patients based on the specific findings of its review and the development of quality improvement initiatives.
(a)
(1) Inform the parties that its complaint review will be discontinued; and
(2) Inform the beneficiary of his or her right to resubmit a written complaint in accordance with the procedures in § 476.120.
(b)
(a)
(1) A QIO may conduct general quality of care reviews based on—
(i) Concerns identified during the course of other QIO review activities;
(ii) Referrals from other sources, including but not limited to individuals, contractors, other Federal or State agencies; or
(iii) Analysis of data.
(2) The QIO's review will focus on all concerns identified by the QIO and/or identified by those who have referred or reported the concerns, with consideration being given to the episode of care related to the concerns.
(3) The QIO will use evidence-based standards of care to the maximum extent practicable. If no standard of care exists, the QIO must use available norms, best practices, and established guidelines to establish the standard that will be used in completing the review. The QIO's determination regarding the standard used is not subject to appeal.
(b)
(c)
(a)
(1) The reconsideration request must be received by the QIO, in writing or by telephone, by no later than 3 calendar days following receipt of the QIO's initial determination. If the QIO is unable to accept the request, the request must be submitted by noon of the next day the QIO is available to accept a request.
(2) The practitioner or provider must be available to answer any questions or supply any information that the QIO requests in order to conduct its reconsideration.
(3) The QIO must offer the practitioner or provider an opportunity to provide further information. A practitioner or provider may, but is not required to, submit evidence to be considered by the QIO in making its reconsideration decision.
(b)
(1) The QIO's initial notification may be done by telephone, followed by the mailing of a written notice by noon the next calendar day that includes:
(i) A statement for each concern that care did or did not meet the standard of care;
(ii) The standard identified by the QIO for each of the concerns;
(iii) A summary of the specific facts that the QIO determines are pertinent to its findings; and
(iv) A statement that the letter represents the QIO's final determination and that there is no right to further appeal.
(2) The QIO may provide information regarding opportunities for improving the care given to patients based on the specific findings of its review.
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 I of this chapter for determinations under Medicare Part A and 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
(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 § 478.14 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, the QIO must provide an opportunity for examination of the material upon which the initial denial determination was based. The QIO may not furnish a provider, practitioner or beneficiary with—
(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 § 476.98 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 § 478.40 and a final decision rendered; or
(b) The reconsidered determination is later reopened and revised in accordance with § 478.48.
(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)
(2) The following part 405 regulations, and any references thereto, specifically do not apply under this subpart:
(i) Section 405.950 (time frames for making a redetermination).
(ii) Section 405.970 (time frames for making a reconsideration following a contractor redetermination, including the option to escalate an appeal to the OMHA level).
(iii) Section 405.1016 (time frames for deciding an appeal of a QIC reconsideration, or escalated request for a QIC reconsideration, including the option to escalate an appeal to the Council).
(iv) The option to request that an appeal be escalated from the OMHA level to the Council as provided in § 405.1100(b), and time frames for the Council to decide an appeal of an ALJ's or attorney adjudicator's decision or an appeal that is escalated from the OMHA level to the Council as provided in § 405.1100(c) and (d).
(v) Section 405.1132 (request for escalation to Federal court).
(vi) Sections 405.956(b)(8), 405.966(a)(2), 405.976(b)(5)(ii), 405.1018(c), 405.1028(a), and 405.1122(c), and any other reference to requiring a determination of good cause for the introduction of new evidence by a provider, supplier, or a beneficiary represented by a provider or supplier.
(a)
(b)
(2) The date of receipt of the notice of the reconsidered determination is presumed to be 5 calendar days after the date on the notice, unless there is evidence to the contrary.
(3) A request is considered filed on the date it is received by OMHA.
(a) After an individual appellant has submitted a request for a hearing, the ALJ or attorney adjudicator determines the amount in controversy in accordance with § 405.1006(d) and (e) of this chapter. When two or more appellants submit a request for hearing, the ALJ or attorney adjudicator determines the amount in controversy in accordance with § 405.1006(d) and (e) of this chapter.
(b) If the ALJ or attorney adjudicator determines that the amount in controversy is less than $200, the ALJ,
(c) At the end of the 15-day period, if an 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 and the QIO that the QIO reconsidered determination is conclusive for Medicare payment purposes.
(a) The circumstances under which the Medicare Appeals Council (Council) will review an ALJ's or attorney adjudicator's decision or dismissal are the same as those set forth at §§ 405.1102 (“Request for Council review when ALJ or attorney adjudicator issues decision or dismissal”) and 405.1110 (“Council reviews on its own motion”) of this chapter.
(b) If $2,000 or more is in controversy, a party may obtain judicial review of a Council decision, or an ALJ's or attorney adjudicator's decision if a request for review by the Council 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 Council 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;
(5) Data support organizations; and
(6) CMS.
(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 beneficiary 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
(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.
(l) Redisclosures of information that is confidential because it identifies the parties involved in immediate advocacy may occur if all parties have consented to the redisclosure, as provided for under § 476.110(c) of this chapter.
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 the records or information are necessary to carry out QIO review responsibilities.
(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 to the Department all information requested by the Department in the manner and form requested. The information can include confidential and non-confidential information and requests can include those made by any component of the Department, such as CMS.
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) Except as provided under paragraph (b) of this section, all other patient and practitioner identifiers have been removed.
(2) Make disclosure to the patient or the patient's representative within 14 calendar days of receipt of the request.
(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.
(c)
(2) In identifying a representative, the QIO must follow pertinent State law requirements regarding the designation of health care representatives and agents. If the patient is unable to designate a representative and the identity of the representative is not already dictated by State law, 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 beneficiary of the information has the same redisclosure rights and responsibilities as the requesting or consenting practitioner or reviewer as provided under this Subpart B.
(iv) A QIO is not required to obtain the consent of a practitioner or provider prior to the release of information to a beneficiary in connection with an initial denial determination or in providing a beneficiary with the QIO's findings in response to a beneficiary complaint. Information that must be specified in a QIO's final decision in a complaint review is specified in §§ 476.130(d) and 476.140(b) of this subchapter.
(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
(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)(1) A QIO must not disclose its deliberations except to—
(i) CMS; or
(ii) The Office of the Inspector General, and the Government Accountability 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 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
(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 beneficiary of the information.
(2) The beneficiary 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.
(g) A QIO must disclose quality review study information to CMS with identifiers of patients, practitioners or institutions—
(1) For purposes of quality improvement. Activities include, but are not limited to, data validation, measurement, reporting, and evaluation.
(2) As requested by CMS when CMS deems it necessary for purposes of overseeing and planning QIO program activities.
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.
CMS may approve the requests of researchers for access to QIO confidential information not already authorized by other provisions in 42 CFR part 480.
(a) Except as otherwise provided under this part, a QIO may not use or disclose a beneficiary's confidential information without an authorization from the beneficiary. The QIO's use or disclosure must be consistent with the authorization.
(b) A valid authorization is a document that contains the following:
(1) A description of the information to be used or disclosed that identifies the information in a specific and meaningful fashion.
(2) The name or other specific identification of the QIO(s) and QIO point(s) of contact making the request to use or disclose the information.
(3) The name or other specific identification of the person(s), or class of persons, to whom the QIO(s) may disclose the information or allow the requested use.
(4) A description of each purpose of the requested use or disclosure. The statement “at the request of the individual” is a sufficient description of the purpose when an individual initiates the authorization and does not, or elects not to, provide a statement of purpose.
(5) An expiration date or an expiration event that relates to the beneficiary or the purpose of the use or disclosure. The statement “end of the QIO research study,” “none,” or similar language is sufficient if the authorization is for a use or disclosure of confidential information for QIO research, including for the creation and maintenance of a research database or research repository.
(6) Signature of the individual and date. If the authorization is signed by a beneficiary's representative, a description of such representative's authority to act for the beneficiary must also be provided.
(c) In addition to those items contained in paragraph (b) of this section, the authorization must contain statements adequate to place the individual on notice of all of the following:
(1) The individual's right to revoke the authorization in writing; and
(2) Any exceptions to the right to revoke and a description of how the individual may revoke the authorization;
(3) The ability or inability of the QIO to condition its review activities on the authorization, by stating either:
(i) That the QIO may not condition the review of complaints, appeals, or payment determinations, or any other QIO reviews or other tasks within the QIO's responsibility on whether the individual signs the authorization;
(ii) The consequences to the individual of a refusal to sign the authorization when the refusal will render the QIO unable to carry out an activity.
(4) The potential for information disclosed pursuant to the authorization to be subject to either appropriate or inappropriate redisclosure by a beneficiary, after which the information would no longer be protected by this subpart.
(d) The authorization must be written in plain language.
(e) If a QIO seeks an authorization from a beneficiary for a use or disclosure of confidential information, the QIO must provide the beneficiary with a copy of the signed authorization.
(f) A beneficiary may revoke an authorization provided under this section at any time, provided the revocation is in writing, except to the extent that the QIO has taken action in reliance upon the authorization.