[Federal Register Volume 62, Number 212 (Monday, November 3, 1997)]
[Notices]
[Pages 59358-59365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-28972]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[BPO-150-N]
Medicare and Medicaid Programs; Quarterly Listing of Program
Issuances--First Quarter 1997
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Notice.
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SUMMARY: This notice lists HCFA manual instructions, substantive and
interpretive regulations, and other Federal Register notices that were
published during January, February, and March of 1997 that relate to
the Medicare and Medicaid programs. It also identifies certain devices
with investigational device exemption numbers approved by the Food and
Drug Administration that may be potentially covered under Medicare.
Section 1871(c) of the Social Security Act requires that we publish
a list of Medicare issuances in the Federal Register at least every 3
months. Although we are not mandated to do so
[[Page 59359]]
by statute, for the sake of completeness of the listing, we are
including all Medicaid issuances and Medicare and Medicaid substantive
and interpretive regulations (proposed and final) published during this
time frame.
FOR FURTHER INFORMATION CONTACT:
Bridget Wilhite, (410) 786-5248 (For Medicare instruction information).
Betty Stanton, (410) 786-3247 (For Medicaid instruction information).
Sharon Hippler, (410) 786-4633 (For Food and Drug Administration-
approved investigational device exemption information).
Cathy Johnson, (410) 786-5241 (For all other information).
SUPPLEMENTARY INFORMATION:
I. Program Issuances
The Health Care Financing Administration (HCFA) is responsible for
administering the Medicare and Medicaid programs, which pay for health
care and related services for 38 million Medicare beneficiaries and 36
million Medicaid recipients. Administration of these programs involves
(1) providing information to Medicare beneficiaries and Medicaid
recipients, health care providers, and the public, and (2) effective
communications with regional offices, State governments, State Medicaid
Agencies, State Survey Agencies, various providers of health care,
fiscal intermediaries and carriers that process claims and pay bills,
and others. To implement the various statutes on which the programs are
based, we issue regulations under the authority granted the Secretary
under sections 1102, 1871, and 1902 and related provisions of the
Social Security Act (the Act) and also issue various manuals,
memoranda, and statements necessary to administer the programs
efficiently.
Section 1871(c)(1) of the Act requires that we publish in the
Federal Register at least every 3 months a list of all Medicare manual
instructions, interpretive rules, and guidelines of general
applicability not issued as regulations. We published our first notice
June 9, 1988 (53 FR 21730). Although we are not mandated to do so by
statute, for the sake of completeness of the listing of operational and
policy statements, we are continuing our practice of including Medicare
substantive and interpretive regulations (proposed and final) published
during the 3-month time frame. Since the publication of our quarterly
listing on June 12, 1992 (57 FR 24797), we decided to add Medicaid
issuances to our quarterly listings. Accordingly, we list in this
notice Medicaid issuances and Medicaid substantive and interpretive
regulations published during January through March 1997.
II. How to Use the Addenda
This notice is organized so that a reader may review the subjects
of all manual issuances, memoranda, substantive and interpretive
regulations, or Food and Drug Administration-approved investigational
device exemptions published during the time frame to determine whether
any are of particular interest. We expect it to be used in concert with
previously published notices. Most notably, those unfamiliar with a
description of our Medicare manuals may wish to review Table I of our
first three notices (53 FR 21730, 53 FR 36891, and 53 FR 50577) and the
notice published March 31, 1993 (58 FR 16837), and those desiring
information on the Medicare Coverage Issues Manual may wish to review
the August 21, 1989 publication (54 FR 34555).
To aid the reader, we have organized and divided this current
listing into five addenda. Addendum I lists the publication dates of
the most recent quarterly listings of program issuances.
Addendum II identifies previous Federal Register documents that
contain a description of all previously published HCFA Medicare and
Medicaid manuals and memoranda.
Addendum III of this notice lists, for each of our manuals or
Program Memoranda, a HCFA transmittal number unique to that instruction
and its subject matter. A transmittal may consist of a single
instruction or many. Often it is necessary to use information in a
transmittal in conjunction with information currently in the manuals.
Addendum IV lists all substantive and interpretive Medicare and
Medicaid regulations and general notices published in the Federal
Register during the quarter covered by this notice. For each item, we
list the date published, the Federal Register citation, the parts of
the Code of Federal Regulations (CFR) that have changed (if
applicable), the agency file code number, the title of the regulation,
the ending date of the comment period (if applicable), and the
effective date (if applicable).
On September 19, 1995, we published a final rule (60 FR 48417)
establishing in regulations at 42 CFR 405.201 et seq. that certain
devices with an investigational device exemption approved by the Food
and Drug Administration and certain services related to those devices
may be covered under Medicare. That final rule states that we will
announce in this quarterly notice all investigational device exemption
categorizations, using the investigational device exemption numbers the
Food and Drug Administration assigns. Addendum V includes listings of
the Food and Drug Administration-approved investigational device
exemption numbers that have been approved or revised during the quarter
covered by this notice. The listings are organized according to the
categories to which the device numbers are assigned (that is, Category
A or Category B) and identified by the investigational device exemption
number.
III. How To Obtain Listed Material
A. Manuals
An individual or organization interested in routinely receiving any
manual and revisions to it may purchase a subscription to that manual.
Those wishing to subscribe should contact either the Government
Printing Office (GPO) or the National Technical Information Service
(NTIS) at the following addresses:
Superintendent of Documents, Government Printing Office, ATTN: New
Orders, PO Box 371954, Pittsburgh, PA 15250-7954, Telephone (202) 512-
1800, Fax number (202) 512-2250 (for credit card orders).
National Technical Information Service, Department of Commerce, 5825
Port Royal Road, Springfield, VA 22161, Telephone (703) 487-4630.
In addition, individual manual transmittals and Program Memoranda
listed in this notice can be purchased from NTIS. Interested parties
should identify the transmittal(s) they want. GPO or NTIS can give
complete details on how to obtain the publications they sell.
Additionally, all manuals are available at the following Internet
address: http//www.hcfa.gov/pubforms/progman.htm.
B. Regulations and Notices
Regulations and notices are published in the daily Federal
Register. Interested individuals may purchase individual copies or
subscribe to the Federal Register by contacting the GPO at the address
given above. When ordering individual copies, it is necessary to cite
either the date of publication or the volume number and page number.
The Federal Register is also available on 24x microfiche and as an
online database through GPO Access. The online database is updated by 6
a.m. each day the Federal Register is published. The database includes
both
[[Page 59360]]
text and graphics from Volume 59, Number 1 (January 2, 1994) forward.
Free public access is available on a Wide Area Information Server
(WAIS) through the Internet and via asynchronous dial-in. Internet
users can access the database by using the World Wide Web; the
Superintendent of Documents home page address is http://
www.access.gpo.gov/su__docs/, by using local WAIS client software, or
by telnet to swais.access.gpo.gov, then log in as guest (no password
required). Dial-in users should use communications software and modem
to call (202) 512-1661; type swais, then log in as guest (no password
required).
C. Rulings
We publish Rulings on an infrequent basis. Interested individuals
can obtain copies from the nearest HCFA Regional Office or review them
at the nearest regional depository library. We have, on occasion,
published Rulings in the Federal Register. In addition, Rulings,
beginning with those released in 1995, are available online, through
the HCFA Home Page. The Internet address is http://www.hcfa.gov/regs/
rulings.htm.
D. HCFA's Compact Disk-Read Only Memory (CD-ROM)
Our laws, regulations, and manuals are also available on CD-ROM,
which may be purchased from GPO or NTIS on a subscription or single
copy basis. The Superintendent of Documents list ID is HCLRM, and the
stock number is 717-139-00000-3. The following material is on the CD-
ROM disk:
Titles XI, XVIII, and XIX of the Social Security Act.
HCFA-related regulations.
HCFA manuals and monthly revisions.
HCFA program memoranda.
The titles of the Compilation of the Social Security Act are
current as of January 1, 1995. The remaining portions of CD-ROM are
updated on a monthly basis.
Because of complaints about the unreadability of the Appendices
(Interpretive Guidelines) in the State Operations Manual (SOM), as of
March 1995, we deleted these appendices from CD-ROM. We intend to re-
visit this issue in the near future, and, with the aid of newer
technology, we may again be able to include the appendices on CD-ROM.
Any cost report forms incorporated in the manuals are included on
the CD-ROM disk as LOTUS files. LOTUS software is needed to view the
reports once the files have been copied to a personal computer disk.
IV. How to Review Listed Material
Transmittals or Program Memoranda can be reviewed at a local
Federal Depository Library (FDL). Under the FDL program, government
publications are sent to approximately 1400 designated libraries
throughout the United States. Interested parties may examine the
documents at any one of the FDLs. Some may have arrangements to
transfer material to a local library not designated as an FDL. To
locate the nearest FDL, contact any library.
In addition, individuals may contact regional depository libraries,
which receive and retain at least one copy of most Federal government
publications, either in printed or microfilm form, for use by the
general public. These libraries provide reference services and
interlibrary loans; however, they are not sales outlets. Individuals
may obtain information about the location of the nearest regional
depository library from any library. Superintendent of Documents
numbers for each HCFA publication are shown in Addendum III, along with
the HCFA publication and transmittal numbers. To help FDLs locate the
instruction, use the Superintendent of Documents number, plus the HCFA
transmittal number. For example, to find the Intermediary Manual, Part
3--Claims Process (HCFA Pub 13-3) transmittal entitled ``Oral Cancer
Drugs,'' use the Superintendent of Documents No. HE 22.8/6 and the HCFA
transmittal number 1700.
V. General Information
It is possible that an interested party may have a specific
information need and not be able to determine from the listed
information whether the issuance or regulation would fulfill that need.
Consequently, we are providing information contact persons to answer
general questions concerning these items. Copies are not available
through the contact persons. Copies can be purchased or reviewed as
noted above.
Questions concerning Medicare items in Addendum III may be
addressed to Bridget Wilhite, Office of Communications and Operations
Support, Division of Regulations and Issuances, Health Care Financing
Administration, Telephone (410) 786-5248.
Questions concerning Medicaid items in Addendum III may be
addressed to Betty Stanton, Center for Medicaid State Operations,
Policy Coordination and Planning Group, Health Care Financing
Administration, C4-25-02, 7500 Security Boulevard, Baltimore, MD 21244-
1850, Telephone (410) 786-3247.
Questions concerning Food and Drug Administration-approved
investigational device exemptions may be addressed to Sharon Hippler,
Office of Clinical Standards and Quality, Coverage Analysis Group,
Health Care Financing Administration, C4-11-04, 7500 Security
Boulevard, Baltimore, MD 21244-1850, Telephone (410) 786-4633.
Questions concerning all other information may be addressed to
Cathy Johnson, Office of Communications and Operations Support,
Division of Regulations and Issuances, Health Care Financing
Administration, C5-12-16, 7500 Security Boulevard, Baltimore, MD 21244-
1850, Telephone (410) 786-5241.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance, Program No. 93.774, Medicare--
Supplementary Medical Insurance Program, and Program No. 93.714,
Medical Assistance Program)
Dated: October 10, 1997.
Pamela J. Gentry,
Director, Office of Communications and Operations Support.
Addendum I
This addendum lists the publication dates of the most recent
quarterly listings of program issuances.
June 26, 1996 (61 FR 33119)
December 18, 1996 (61 FR 66676)
April 21, 1997 (62 FR 19328)
May 12, 1997 (62 FR 25957)
Addendum II--Description of Manuals, Memoranda, and HCFA Rulings
An extensive descriptive listing of Medicare manuals and memoranda
was published on June 9, 1988, at 53 FR 21730 and supplemented on
September 22, 1988, at 53 FR 36891 and December 16, 1988, at 53 FR
50577. Also, a complete description of the Medicare Coverage Issues
Manual was published on August 21, 1989, at 54 FR 34555. A brief
description of the various Medicaid manuals and memoranda that we
maintain was published on October 16, 1992, at 57 FR 47468.
[[Page 59361]]
Addendum III.--Medicare and Medicaid Manual Instructions
[January 1997 through March 1997]
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Trans. No. Manual/Subject/Publication No.
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Intermediary Manual Part 3--Claims Process (HCFA Pub. 13-3)
(Superintendent of Documents No. HE 22.8/6)
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1696 Review of Form HCFA-1450 for Inpatient and
Outpatient Bills.
Bill Review for Partial Hospitalization
Services Provided in Community Mental Health
Centers.
Pneumoccocal Pneumonia Influenza Virus and
Hepatitis B Vaccines.
1697 Laboratory Tests for Hemodialysis,
Intermittent Peritoneal Dialysis and
Continuous Cycling Peritoneal Dialysis
Included in Composite Rate.
Laboratory Tests for CAPD Covered Routinely
and Separately Billable.
1698 Review of Form HCFA-1450 for Inpatient and
Outpatient Bills.
Review of Hospice Bills.
1699 Medical--Subject to Waiver.
1700 Oral Cancer Drugs.
Self-Administered Antiemetic Drugs
Mammography Quality Standards Act.
1701 Hospital Outpatient Partial Hospitalization
Services.
1702 Billing for Durable Medical Equipment Orthotic/
Prosthetic Devices and Surgical Dressings.
1703 Applicability of Limitation on Liability to
Items or Services Furnished by Providers of
Services Payable Under Part A
When to Make Limitation on Liability
Decisions.
1704 Contractor Data Security and Confidentiality
Requirements.
File Specifications, Records Specifications,
and Data Element Definitions for EMC Bills.
Electronic Media Claims.
Requirements for Submission of EMC Data.
Claims Processing Timeliness.
1705 Federal BL Program Address.
1706 Ambulance Services.
1707 Review of Form HCFA-1450 for Inpatient and
Outpatient Bills.
EMC Flat File Record for ESRD Medical
Documentation--Record Type (RT) 76.
Flat File Requirements for RT 76, ESRD Medical
Documentation.
Provider Electronic Billing File and Record
Format.
Alphabetic Listing of Data Elements.
Medical Review Attachment Data Definitions and
Codes.
1708 Routine Services and Appliances.
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Carriers Manual Part 2--Program Administration (HCFA Pub. 14-2)
(Superintendent of Documents No. HE 22.8/7-3)
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13 Claims Processing Timeliness.
Functional Standards for Claims Processing
Operations.
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Carriers Manual Part 3--Claims Process (HCFA Pub. 14-3) (Superintendent
of Documents No. HE 22.8/7)
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1555 Reasonableness and Necessity.
1556 Beneficiary Address Change.
1557 Laboratory Tests.
Separately Billable Tests Furnished to
Patients of Independent Dialysis Facilities.
1558 Type of Service.
1559 Reasonableness and Necessity.
1560 Contractor Data Security and Confidentiality
Requirements.
EMC Testing and Verification.
Data Sets and Formats for EMC and Electronic
Remittance Advice.
Requirements for Processing EMC.
Technical Requirements.
Requirements for Processing EMC.
1561 Federal Black Lung Program Address.
Charges by Relative or Member of Immediate
Household.
Duplicate and/or Overlapping Bills With
Discrepant Charges.
Evidence of Medical Necessity for Parenteral
and Enteral Nutrition.
TPP Pays Primary Benefits When Not Required.
Federal Government's Right to Sue and Collect
Double Damages.
Documentation of Conformance.
When Medicare Secondary Benefits are Payable.
When Medicare Secondary Benefits are Not
Payable.
Calculating Medicare Secondary Payments for
Services Reimbursed on Reasonable Charge or
Other Basis Under Part B.
Effect of Failure to File Proper Claim.
Effect of Primary Payments on Deductibles and
Coinsurance.
Right of Physician or Supplier to Charge
Beneficiary.
Charging Expenses Against Annual Limit on
Incurred Expenses for Services of
Independently Practicing Physical Therapist.
Nondiscrimination.
Medicare Secondary Payment for Managed Care
Organization Copayments.
Individuals Receiving Delayed Compensation
Payments Subject to FICA Taxes.
Referral to Internal Revenue Services.
Primary Payer is Bankrupt or Insolvent.
[[Page 59362]]
Determining Size of Employers.
Current Employment Status.
Limitation on Payment for Services to
Individuals Entitled to Benefits on the Basis
of ESRD Who are Covered by GHPs.
Prohibition Against Taking into Account,
Medicare Eligibility or Entitlement and
Benefit Differentiation During Coordination
Period.
Determining Period During Which Medicare May
Be Secondary Payer.
Dual Eligibility/Entitlement Situations.
Effect of ESRD MSP on Consolidated Omnibus
Budget Reconciliation Act Continuation
Coverage.
Medicare Secondary Payer Provision for
Disabled Beneficiaries
Items and Services Furnished on or After
August 10, 1993 and Before October 1, 1998.
Individuals Not Subject to MSP Provision.
The 100-or-More Employees Requirement.
Disabled Individuals Who Return to Work.
Dually-Entitled Individuals.
Items and Services Furnished on or After
January 1, 1987 and Before August 10, 1993.
Prohibition Against Financial and Other
Incentives.
Federal Government's Right to Sue and Collect
Double Damages.
Excise Tax Penalties for Contributors to
Nonconforming Group Health Plans.
1563 Paper Remittance Notice Requirements.
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Program Memorandum Intermediaries (HCFA Pub. 60A) (Superintendent of
Documents No. HE 22.8/6-5)
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A-97-1 Extension of Due Date for Filing Provider 2552-
96 Cost Reports.
A-97-2 Hospital Outpatient Procedures: Medicare
Changes for Radiology and Other Diagnostic
Coding Due to the 1997 HCPCS Update and New
Dermatology HCPCS Codes.
A-97-3 Cost Report Filing Requirements for Hospitals
with Multiple Skilled Nursing Facilities.
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Program Memorandum Intermediaries/Carriers (HCFA Pub. 60A/B)
(Superintendent of Documents No. HE 22.8/6-5)
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AB-96-12 Sterile Intravitreal Implant with Cytovene
(Trade Name: Vitrasert).
AB-96-13 Revaccination of Beneficiaries Who Received
Recalled Influenza Virus Vaccine.
AB-97-1 New Interest Rate Payable on Clean Claims Not
Paid Timely.
AB-97-2 Calculation Methodology for Hematocrit Levels
Used to Determine the Applicability of
Payment for EPO Provided to ESRD Patients.
AB-97-3 Binding Contractor Hearing Officers to L/RMRP.
AB-97-4 Common Working File (CWF) Crossover Edits in
Release 97.1.
AB-97-5 New Panels Approved by CPT.
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State Operations Manual Provider Certification (HCFA Pub. 7)
(Superintendent of Documents No. HE 22.8/12)
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279 Model Letter to Provider (Send with Form HCFA-
2567) (Immediate Jeopardy Does Not Exist)
Model Letter Notifying Provider Acceptance of
Allegation of Compliance.
Model Letter Notifying Provider of Results of
Revisit.
Notice Requirements.
Timing of CMPs.
Procedures for Recommending Enforcement
Remedies When Immediate Jeopardy Does Not
Exist.
Response to Allegation of Compliance.
Basis for Imposing CMPs.
280 Updates of Interpretive Guidelines and Survey
Procedures for Hospitals.
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Hospital Manual (HCFA Pub. 10) (Superintendent of Documents No. HE 22.8/
2)
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704 Outpatient Therapeutic Services.
705 Pneumococcal Pneumonia Influenza Virus and
Hepatitis B Vaccines.
706 Laboratory Tests for Hemodialysis,
Intermittent Peritoneal Dialysis (IPD) and
Continuous Cycling Peritoneal Dialysis (CCPD)
Included in Composite Rate.
Laboratory Tests for CAPD Covered Routinely
and Separately Billable.
707 Oral Cancer Drugs.
Self-Administered Antiemetic Drugs.
708 Billing for Hospital Outpatient Partial
Hospitalization Services.
709 Billing for DME, Orthotic/Prosthetic Devices
and Surgical Dressings.
710 Ambulance Service Claims.
711 Outpatient Therapeutic Services.
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[[Page 59363]]
Home Health Agency Manual (HCFA Pub. 11) (Superintendent of Documents
No. HE 22.8/5)
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282 Billing for Oral Cancer Drugs.
Self-Administered Antiemetic Drugs.
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Medicare Renal Dialysis Facility Manual (Non-Hospital Operated) (HCFA
Pub. 29) (Superintendent of Documents No. HE 22.8/13)
------------------------------------------------------------------------
77 Laboratory Tests for Hemodialysis, IPD and
CCPD.
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Medicare Outpatient Physical Therapy and Comprehensive Outpatient
Rehabilitation Facility Manual (HCFA Pub. 9) (Superintendent of
Documents No. HE 22.8/9)
------------------------------------------------------------------------
129 Billing Instructions for Partial
Hospitalization Services Provided in
Community Mental Health Centers.
------------------------------------------------------------------------
Medicare Coverage Issues Manual (HCFA Pub. 6) (Superintendent of
Documents No. HE 22.8/14)
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91 Laboratory Tests--CRD Patients.
92 Osteogenic Stimulation.
93 Treatment of Motor Function Disorders with
Electric Nerve Stimulation.
Transmyocardial Revascularization With Laser--
Not Covered.
Intraocular Lenses (IOL).
Partial Ventriculectomy (Also known as
Ventricular Reduction, Ventricular Remodeling
or Heart Volume Reduction Surgery).
Cryosurgery of Prostate.
Vertebral Axial Decompression (VAX-D).
Infusion Pumps.
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Medicare Provider Reimbursement Manual Part 1--(HCFA Pub.15-1)
(Superintendent of Documents No. HE 22.8/4)
------------------------------------------------------------------------
398 Regional Medicare Swing-Bed SNF Rates.
------------------------------------------------------------------------
Provider Reimbursement Manual Part II--Provider Cost Reporting Forms
and Instructions (HCFA Pub. 15-II-AF) (Superintendent of Documents No.
HE 22.8/4)
------------------------------------------------------------------------
3 Home Health Agency Complex Identification
Data.
Adjustments to Expenses.
Cost Allocation--General Service Costs, and
Cost Allocation--Statistical Basis.
4 Home Health Agency Cost Report.
Home Health Agency Complex Identification
Data.
Cost Allocation--General Service Costs, and
Cost Allocation--Statistical Basis.
Cost Center Coding.
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State Medicaid Manual--Part 3--Eligibility (HCFA Pub. 45-3)
(Superintendent of Documents No. HE 22.8/10)
------------------------------------------------------------------------
67 Changes Due to Welfare Reform.
Changes in SSI Definition of Disability Due to
Welfare Reform.
Citizenship and Alienage.
Aliens.
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State Medicaid Manual--Part 4--Services (HCFA Pub. 45-4)
(Superintendent of Documents No. HE 22.8/10)
------------------------------------------------------------------------
70 Home Respiratory Care for Ventilator-Dependent
Individuals.
Home and Community-Based Services--Basis,
Scope, and Purpose.
Description of Waiver Participants.
Definition of Services.
Safeguards--Assurances and Documentation.
Evaluations--Assurances and Documentation.
Cost Effectiveness--Assurances and
Documentation.
Annual Report--Assurances and Documentations.
Independent Assessment of the Waiver.
Home and Community-Based Services--Model
Waiver Request.
Home and Community-Based Services--Procedures
to Request Renewal of Approved Waivers.
Home and Community-Based Services--Amendments.
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State Medicaid Manual--Part 6 Payment for Services (HCFA Pub. 45-6)
(Superintendent of Documents No. HE 22.8/10)
------------------------------------------------------------------------
33 Physician Services to Children Under 21.
Physician Services to Pregnant Women.
------------------------------------------------------------------------
Medicare/Medicaid Sanction--Reinstatement Report (HCFA Pub. 69)
------------------------------------------------------------------------
97-1 Report of Physicians/Practitioners, Providers
and/or Other Health Care Suppliers Excluded/
Reinstated--December 1996.
[[Page 59364]]
97-2 Cumulative Report of Physicians/Practitioners,
Providers and/or Other Health Care Suppliers
Sanctioned/Reinstated.
97-3 Report of Physicians/Practitioners, Providers
and/or Other Health Care Suppliers Excluded/
Reinstated--January 1997.
97-4 Report of Physicians/Practitioners, Providers
and/or Other Health Care Suppliers Excluded/
Reinstated--February 1997.
------------------------------------------------------------------------
Addendum IV.--Regulation Documents Published in the Federal Register
--------------------------------------------------------------------------------------------------------------------------------------------------------
End of
Publication date FR vol. 61 CFR File code* Regulation title comment Effective
page part(s) period date
--------------------------------------------------------------------------------------------------------------------------------------------------------
01/02/97........................ 26-31 413 BPD-788-F Medicare Program; Electronic ........... 02/01/97
Cost Reporting for Skilled
Nursing Facilities and Home
Health Agencies.
01/13/97........................ 1682-1685 435 MB-105-FC Medicaid Program; 03/14/97 01/13/97
Redeterminations of Medicaid
Eligibility Due to Welfare
Reform.
01/13/97........................ 1768-1776 ......... BPD-882-N Notification Procedures for ........... ...........
States Implementing
``Alternative Mechanisms'' in
the Individual Health
Insurance Market.
01/16/97........................ 2373-2374 ......... ORD-095-N New and Pending Demonstration ........... ...........
Project Proposals Submitted
Pursuant to Section 1115(a) of
the Social Security Act:
November 1996.
01/23/97........................ 3563 ......... BPD-886-N Department of Health and Human ........... ...........
Services, Health Care
Financing Administration;
Department of Labor, Pension
and Welfare Benefits
Administration; and Department
of the Treasury, Office of Tax
Policy and Internal Revenue
Service (the Agencies );
Health Insurance Portability;
Correction.
01/29/97........................ 4305-4311 ......... ORD-089-N Medicare and Medicaid Programs; ........... ...........
Small Business Innovation
Research Grants for Fiscal
Year 1997.
01/31/97........................ 4772-4776 ......... MB-104-N Medicaid Program; Preliminary ........... ...........
Limitations on Aggregate
Payments to Disproportionate
Share Hospitals: Federal
Fiscal Year 1997.
02/05/97........................ 5433-5442 ......... HSQ-244-N CLIA Program; Clinical ........... 10/28/96
Laboratory Improvement
Amendments of 1988--Denial of
Exemption of Laboratories in
the Commonwealth of Puerto
Rico.
02/21/97........................ 7945-7946 410 BPD-852-CN Medicare Program; Revisions to ........... 01/01/97
415 Payment Policies and Five-Year
Review of and Adjustments to
the Relative Value Units Under
the Physician Fee Schedule for
Calendar Year 1997; Correction.
02/25/97........................ 8451-8452 ......... ORD-096-N New and Pending Demonstration ........... ...........
Project Proposals Submitted
Pursuant to Section 1115(a) of
the Social Security Act:
December 1996.
03/06/97........................ 10286 ......... OPL-014-N Medicare Program; March 24, ........... ...........
1997 Meeting of the Practicing
Physicians Advisory Council.
03/10/97........................ 11035-11064 484 HSQ-238-P Medicare and Medicaid Programs; 06/09/97 ...........
Use of the OASIS as Part of
the Conditions of
Participation for Home Health
Agencies.
03/10/97........................ 11005-11035 484 BPD-819-P Medicare and Medicaid Programs; 06/09/97 ...........
Conditions of Participation
for Home Health Agencies.
03/28/97........................ 14851-14878 413 BPD-808-P Medicare and Medicaid Programs; 05/27/97 ...........
Salary Equivalency Guidelines
for Physical Therapy,
Respiratory Therapy, Speech
Language Pathology, and
Occupational Therapy Services.
03/31/97........................ 15187-15191 ......... ORD-097-N New and Pending Demonstration ........... ...........
Project Proposals Submitted
Pursuant to Section 1115(a) of
the Social Security Act:
January 1997 and Supplement to
December 1996 Listing.
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 59365]]
Addendum V--Categorization of Food and Drug Administration-Approved
Investigational Device Exemptions
Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360c), devices
fall into one of three classes. Also, under the new categorization
process to assist HCFA, the Food and Drug Administration assigns each
device with a Food and Drug Administration-approved investigational
device exemption to one of two categories. To obtain more information
about the classes or categories, please refer to the Federal Register
notice published on April 21, 1997 (62 FR 19328).
The following information presents the device number, category (in
this case, A), and criterion code.
G960213 A2
G960218 A1
G960258 A1
G960266 A1
G970004 A1
G970007 A1
G970015 A2
G970016 A2
G970018 A2
G970022 A2
G970035 A2
G970051 A2
G970053 A2
The following information presents the device number category (in
this case, B), and criterion code.
G950115 B1
G956391 B2
G960193 B4
G960199 B2
G960208 B1
G960229 B1
G960230 B2
G960231 B3
G960234 B4
G960235 B3
G960241 B2
G960243 B2
G960245 B2
G960246 B1
G960247 B1
G960248 B4
G960249 B4
G960250 B3
G960252 B2
G960253 B4
G960254 B2
G960255 B2
G960256 B1
G960257 B3
G960259 B4
G960262 B3
G960263 B3
G960264 B3
G960267 B1
G970001 B3
G970002 B4
G970003 B3
G970005 B4
G970011 B2
G970012 B4
G970019 B3
G970023 B4
G970025 B3
G970026 B3
G970028 B3
G970029 B3
G970030 B1
G970031 B3
G970032 B3
G970033 B4
G970034 B4
G970037 B4
G970038 B4
G970039 B4
G970040 B3
G970041 B4
G970046 B1
G970047 B3
G970052 B1
G970054 B4
G970059 B3
[FR Doc. 97-28972 Filed 10-31-97; 8:45 am]
BILLING CODE 4120-03-P