[Federal Register Volume 65, Number 104 (Tuesday, May 30, 2000)]
[Notices]
[Pages 34481-34489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-13347]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

[HCFA-9001-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--Third Quarter, 1999

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice lists HCFA manual instructions, substantive and 
interpretive regulations, and other Federal Register notices that were 
published during July, August, and September of 1999, relating to the 
Medicare and Medicaid programs. This notice also identifies certain 
devices with investigational device exemption numbers approved by the 
Food and Drug Administration that potentially may be 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 by statute, for the sake 
of completeness of the listing, we are also including all Medicaid 
issuances and Medicare and Medicaid substantive and interpretive 
regulations (proposed and final) published during this timeframe.

FOR FURTHER INFORMATION CONTACT: 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.
    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, C5-16-03, 7500 Security Boulevard, Baltimore, MD 21244-
1850, (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, S2-26-13, 7500 Security Boulevard, Baltimore, MD 21244-
1850, (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 and Analysis Group, 
Health Care Financing Administration, C4-11-04, 7500 Security 
Boulevard, Baltimore, MD 21244-1850, (410) 786-4633.
    Questions concerning all other information may be addressed to 
Trenesha Fultz, Office of Communications and Operations Support, 
Division of Regulations and Issuances, Health Care Financing 
Administration, C5-12-08, 7500 Security Boulevard, Baltimore, MD 21244-
1850, (410) 786-3822.

SUPPLEMENTARY INFORMATION:  

I. Program Issuances

    The Health Care Financing Administration (HCFA) is responsible for 
administering the Medicare and Medicaid programs. These programs pay 
for health care and related services for 39 million Medicare 
beneficiaries and 35 million Medicaid recipients. Administration of 
these programs involves (1) furnishing 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 to the Secretary of the Department of Health and 
Human Services under sections 1102, 1871, 1902, and related provisions 
of the Social Security Act (the Act). We also issue various manuals, 
memoranda, and statements necessary to administer the programs 
efficiently.
    Section 1871(c)(1) of the Act requires that we publish a list of 
all Medicare manual instructions, interpretive rules, and guidelines of 
general applicability not issued as regulations at least every 3 months 
in the Federal Register. 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.

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-

[[Page 34482]]

approved investigational device exemptions published during the 
timeframe to determine whether any are of particular interest. We 
expect it to be used in concert with previously published notices. 
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) published in 1988, and the notice published March 31, 
1993 (58 FR 16837). 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:
    <bullet> Addendum I lists the publication dates of the most recent 
quarterly listings of program issuances.
    <bullet> Addendum II identifies previous Federal Register documents 
that contain a description of all previously published HCFA Medicare 
and Medicaid manuals and memoranda.
    <bullet> Addendum III lists a unique HCFA transmittal number for 
each instruction in our manuals or Program Memoranda 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.
    <bullet> 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;
    + Federal Register citation;
    + Parts of the Code of Federal Regulations (CFR) that have changed 
(if applicable);
    + Agency file code number;
    + Title of the regulation;
    + Ending date of the comment period (if applicable); and
    + Effective date (if applicable).
    <bullet> 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. 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. It is our practice to announce all 
investigational device exemption categorizations, using the 
investigational device exemption numbers the Food and Drug 
Administration assigns. 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

    Those wishing to subscribe to program manuals 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, P.O. Box 
371954, Pittsburgh, PA 15250-7954, Telephone (202) 512-1800, Fax number 
(202) 512-2250 (for credit card orders); or
    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 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/nara/index.html, 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. 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 and 
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:
    <bullet> Titles XI, XVIII, and XIX of the Act.
    <bullet> HCFA-related regulations.
    <bullet> HCFA manuals and monthly revisions.
    <bullet> HCFA program memoranda.
    The titles of the Compilation of the Social Security Laws are 
current as of January 1, 1995. (Updated titles of the Social Security 
Laws are available on the Internet at http://www.ssa.gov/OP__Home/
ssact/comp-toc.htm.) 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 1,400 designated libraries 
throughout the United States. Some FDLs may have arrangements to 
transfer material to a local library not designated as an FDL. Contact 
any library to locate the nearest FDL.

[[Page 34483]]

    In addition, individuals may contact regional depository libraries 
that 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 materials, 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 ``Outpatient Therapeutic Services,'' use the 
Superintendent of Documents No. HE 22.8/6 and the HCFA transmittal 
number 1778.


(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: May 22, 2000.
Elizabeth Cusick,
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 4, 1998 (63 FR 30499)
August 11, 1998 (63 FR 42857)
September 16, 1998 (63 FR 49598)
December 9, 1998 (63 FR 67899)
May 11, 1999 (64 FR 25351)
November 2, 1999 (64 FR 59185)
December 7, 1999 (64 FR 68357)
January 10, 2000 (65 FR 1400)

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 (57 FR 
47468).

                            Addendum III.--Medicare and Medicaid Manual Instructions
                                       [July 1999 through September 1999]
----------------------------------------------------------------------------------------------------------------
                 Trans. No.                                         Manual/Subject/Publication No.
----------------------------------------------------------------------------------------------------------------
                                               Intermediary Manual
                                     Part 3--Claims Process (HCFA Pub.13-3)
                                   (Superintendent of Documents No. HE 22.8/6)
----------------------------------------------------------------------------------------------------------------
1778                                          <bulle  Outpatient Therapeutic Services
                                                t
                                                      Oral Anti-Nausea Drugs as Full Therapeutic Replacements
                                                       for Intravenous Dosage Forms as Part of Cancer
                                                       Chemotherapeutic Regimen
1779                                          <bulle  Requirements-General
                                                t
                                                      Election Procedures
                                                      Election, Revocation, and Change of Hospice
                                                      Covered Services
                                                      Special Coverage Requirements
1780                                          <bulle  Electronic Media Claims
                                                t
                                                      Requirements for Submission of Electronic Media Claims
                                                       Data
                                                      File Specifications, Records Specifications, and Data
                                                       Element Definitions for Electronic Media Claims Bills
                                                      Medicare Intermediary Standard Paper Remittance
                                                      Electronic UB-92 Change Request Procedures
                                                      Medicare Standard Electronic Remittance
                                                      Support of Non-Millennium Electronic Formats
                                                      National Standard Electronic Remittance Advice
1781                                          <bulle  Prospective Payment System PRICER Program
                                                t
                                                      Provider--Specific Payment Data
                                                      Provider Specific Data Record Layout and Description
                                                      Intermediary Responsibilities
----------------------------------------------------------------------------------------------------------------
                                                 Carriers Manual
                                     Part 3--Claims Process (HCFA Pub. 14-3)
                                   (Superintendent of Documents No. HE 22.8/7)
----------------------------------------------------------------------------------------------------------------
1642                                          <bulle  Self-Administered Drugs and Biologicals
                                                t
                                                      Payment for Oral Anti-emetic Drugs When Used as Full
                                                       Replacement for Intravenous Anti-emetic Drugs as Part of
                                                       a Cancer Chemotherapeutic Regimen
1643                                          <bulle  Claims Involving Beneficiaries Who Have Elected Hospice
                                                t      Coverage
1644                                          <bulle  Reimbursement for Physician's Visits to Nursing Home
                                                t      Patients
                                                      Physicians' Services Paid Under Fee Schedule
                                                      Entities/Suppliers Whose Physicians' Services Are Paid for
                                                       Under Fee Schedule
                                                      Payment at Medically Directed Payment Rate
                                                      Specific Hematology, Cytopathology, and Blood Banking
                                                       Services
                                                      Payment Conditions for Radiology Services
                                                      Payment for Physicians Services Furnished to Dialysis
                                                       Inpatients
                                                      Payment for Initial Hospital Care Services
                                                      Consultations
                                                      Reporting of Visit When Patient is Seen in Emergency
                                                       Department and Emergency Department Physician Requests
                                                       Another Physician to See the Patient in Emergency
                                                       Department or Office/Outpatient Setting
                                                      Home Services
1645                                          <bulle  Reassignment
                                                t

[[Page 34484]]

 
                                                      Payment to Employer of Physician
                                                      Payment to Facility in Which Services Are Performed
                                                      Payment to Health Care Delivery System
                                                      Payment to Physician for Purchased Diagnostic Tests
                                                      Payment to Supplier of Diagnostic Tests for Purchased
                                                       Interpretations
                                                      Payment Under Locum Tenens Arrangements
1646                                          <bulle  Requirements for Electronic Data Interchange
                                                t
                                                      Telecommunications Systems and Methods
                                                      Electronic Data Interchange System
                                                      Electronic Data Interchange Testing and Verification
                                                      Technical Requirements
                                                      Technical Assistance for Electronic Data Interchange
                                                       Trading Partners
                                                      Prohibition of Exclusive Use of Proprietary Software
                                                      Hardware
                                                      Medicare Standard Personal Computer-Print B Software
                                                      Support of Non-Millennium Electronic Formats
                                                      National Standard Format Maintenance Procedures
1647                                          <bulle  Correct Coding Initiative
                                                 t
1648                                          <bulle  Colorectal Cancer Screening
                                                 t
                                                      Bone Mass Measurements.
1649                                          <bulle  Pancreas Transplants
                                                 t
----------------------------------------------------------------------------------------------------------------
                                               Program Memorandum
                                         Intermediaries (HCFA Pub. 60A)
                                  (Superintendent of Documents No. HE 22.8/6-5)
----------------------------------------------------------------------------------------------------------------
A-99-31                                       <bulle  Clarifications to Program Memorandum A-99-6, Dated
                                                 t     February 1999, 15 Minute Increment Reporting for Home
                                                       Health Services
A-99-32                                       <bulle  Medical Review Activities Following the Removal of Home
                                                 t     Health Sequential Billing Edits--Regional Home Health
                                                       Intermediaries Only
A-99-33                                       <bulle  Change in Hospice Payment Rates, Update to the Hospice
                                                 t     Cap, Revised Hospice Wage Index and Hospice PRICER.
A-99-34                                       <bulle  Implementation of Federal Register Notice to be Published
                                                 t     on or About July 30, 1999 of Revised Per-Beneficiary and
                                                       Per Visit Limitations on Home Health Agency Costs for
                                                       Cost Reporting Periods Beginning on or After October 1,
                                                       1999 and Portions of Cost Reporting Periods Beginning
                                                       Before October 1, 2000
A-99-35                                       <bulle  Change to Reporting of Outpatient Rehabilitation Services
                                                 t     and All Comprehensive Outpatient Rehabilitation Agency
                                                       Services Using HCFA Common Procedure Coding System
A-99-36                                       <bulle  Year 2000 Procedures: Develop Modified System for
                                                 t     Beneficiary Requests for Immediate Peer Review
                                                       Organization Review of Hospital Issued Notices of
                                                       Noncoverage
A-99-37                                       <bulle  Home Health Advance Beneficiary Notices Must Be Given to
                                                 t     Beneficiaries by Home Health Agencies and Demand Bills
                                                       Must Be Submitted Promptly
A-99-38                                       <bulle  Home Health Advance Beneficiary Notices Must Be Given to
                                                 t     Beneficiaries by Home Health Agencies and Demand Bills
                                                       Must Be Submitted Promptly
A-99-39                                       <bulle  Payment Safeguard Review Instructions for Psychiatric
                                                 t     Partial Hospitalization Claims
A-99-40                                       <bulle  Deactivation of Inactive Community Mental Health Center
                                                 t     Medicare Numbers
A-99-41                                       <bulle  Clarification of Modifier Usage in Reporting Outpatient
                                                 t     Hospital Services
A-99-42                                       <bulle  The Supplemental Security Income Medicare Beneficiary Data
                                                 t     for Fiscal Year 1998 for Prospective Payment System
                                                       Hospitals
----------------------------------------------------------------------------------------------------------------
                                               Program Memorandum
                                            Carriers (HCFA Pub. 60B)
                                  (Superintendent of Documents No. HE 22.8/6-5)
----------------------------------------------------------------------------------------------------------------
B-99-29                                       <bulle  Returns From Year 2000 Mailing
                                                 t
B-99-30                                       <bulle  Changes to the 1999 Medicare Physician Fee Schedule
                                                 t     Database
B-99-31                                       <bulle  Change to Health Insurance Claim Form HCFA-1500
                                                 t     Instructions for Processing Physician Claims in Global
                                                       Payment Systems
B-99-32                                       <bulle  Durable Medical Equipment Regional Carrier Instructions to
                                                 t     Implement Balanced Budget Act of 1997 Provisions Sec.
                                                       4105 to Provide Expanded Coverage of Blood Glucose
                                                       Monitors and Test Strips for all Diabetics. Implement
                                                       July 1, 1998
B-99-33                                       <bulle  Change to Health Insurance Claim Form HCFA-1500
                                                 t     Instructions for Processing Physician Claims in Global
                                                       Payment Systems
B-99-34                                       <bulle  Site Visits and Enrollment of Independent Diagnostic
                                                 t     Testing Facilities
----------------------------------------------------------------------------------------------------------------

[[Page 34485]]

 
                                               Program Memorandum
                                    Intermediaries/Carriers (HCFA Pub. 60A/B)
                                  (Superintendent of Documents No. HE 22.8/6-5)
----------------------------------------------------------------------------------------------------------------
AB-99-50                                      <bulle  Further Delay of Change Request 796 (Coverage Issues
                                                 t     Manual Sec.  35-10 Hyperbaric Oxygen Therapy)
AB-99-51                                      <bulle  Limited Medicare Coverage and Billing Instructions for
                                                 t     Enhanced External Counterpulsation
AB-99-52                                      <bulle  Suspension of National Coverage Policy on
                                                 t     Electrostimulation for Wound Healing
AB-99-53                                      <bulle  Final Rule Revising and Updating Medicare Policies
                                                 t     Concerning Ambulance Services
AB-99-54                                      <bulle  Clarification of Program Memorandum AB-99-27--
                                                 t     Implementation of Calendar Year 2000 Fee Schedules and
                                                       Pricing Updates
AB-99-55                                      <bulle  Transmittal Number AB-99-55 has been rescinded and will
                                                 t     not be released
AB-99-56                                      <bulle  Biomedical Equipment Year 2000 Compliance
                                                 t
AB-99-57                                      <bulle  October 1, 1999 Payment and Coding Updates
                                                 t
AB-99-58                                      <bulle  Modified Procedures for Sharing HCFA Data with the
                                                 t     Department of Justice
AB-99-59                                      <bulle  Medicare Coverage of Epoetin Alfa (Procrit) for
                                                 t     Preoperative Use
AB-99-60                                      <bulle  Notice of New Interest Rate for Medicare Overpayments and
                                                 t     Underpayments
AB-99-61                                      <bulle  Mandatory Submission of Social Security Account Numbers
                                                 t     and Employer Identification Numbers
AB-99-62                                      <bulle  Quarterly Update for 1999 Durable Medical Equipment,
                                                 t     Prosthetics, Orthotics, and Supplies Fee Schedule
AB-99-63                                      <bulle  Implementation of the New Payment Limit for Drugs and
                                                 t     Biologicals.
AB-99-64                                      <bulle  Education of Medicare Providers on the Adoption of
                                                  t    Standard Electronic Health Care Transaction Formats in
                                                       the United States
AB-99-65                                      <bulle  Implementing Coordination of Benefits Contractor Numbers
                                                  t
AB-99-66                                      <bulle  Provider Education Article: Submitting, Processing, and
                                                  t    Paying Year 2000 Medicare Claims
AB-99-67                                      <bulle  Update of Rates and Wage Index for Ambulatory Surgical
                                                  t    Center Payments Effective October 1, 1999
AB-99-68                                      <bulle  Provider Education Article: National Provider Education
                                                  t    and Training Program
AB-99-69                                      <bulle  Instruction Implementation Reporting
                                                  t
AB-99-70                                      <bulle  Provider Education Article: Submitting, Processing, and
                                                  t    Paying Year 2000 Medicare Claims
AB-99-71                                      <bulle  Year 2000 HCFA Common Procedure Coding System Update
                                                  t
----------------------------------------------------------------------------------------------------------------
                                               Program Memorandum
                                      State Survey Agencies (HCFA Pub. 65)
                                  (Superintendent of Documents No. HE 22.8/6-5)
----------------------------------------------------------------------------------------------------------------
99-1                                          <bulle  Policy Clarification: Home Health Agency Parent, Branch
                                                  t    and Subunit Criteria
----------------------------------------------------------------------------------------------------------------
                                 State Operations Manual Provider Certification
                                                  (HCFA Pub. 7)
                                  (Superintendent of Documents No. HE 22.8/12)
----------------------------------------------------------------------------------------------------------------
10                                            <bulle  Roster/Sample Matrix
                                                  t
                                                      Roster/Sample Matrix Provider Instructions
                                                      Roster/Sample Matrix Surveyor Instructions
                                                      Facility Characteristics
                                                      Facility Quality Indicator Profile
                                                      Resident Level Summary
                                                      Quality Indicator Matrix
                                                      Survey Procedures for Long Term Care Facilities
                                                      Guidance to Surveyors
----------------------------------------------------------------------------------------------------------------
                                         Peer Review Organization Manual
                                                  (HCFA Pub 19)
                                  (Superintendent of Documents No HE 22 8/8-15)
----------------------------------------------------------------------------------------------------------------
74                                            <bulle  Purpose of Peer Review Organization Review
                                                  t
                                                      Peer Review Organization Responsibilities
                                                      Health Care Financing Administration's Role
                                                      Health Care Quality Improvement Program
                                                      Payment Error Prevention Program
75                                            <bulle  Objectives of the Internal Quality Control Program
                                                  t
                                                      Internal Quality Control Program Requirements
                                                      Internal Quality Control Process
                                                      Analysis and Reporting Requirements
                                                      Peer Review Organization Review Documentation
                                                      Reporting Requirements
                                                      Peer Review Organization Intermediary Data Exchange
                                                       Reports
76                                            <bulle  Authority
                                                  t
                                                      Scope of Review
                                                      Complaints That Do Not Meet Statutory Requirements
                                                      Referrals
                                              ......  Review Process
                                              ......  Notice of Disclosure

[[Page 34486]]

 
                                              ......  Disclosure of Quality Review Information to Complaints
----------------------------------------------------------------------------------------------------------------
                                                 Hospice Manual
                                                 (HCFA Pub. 21)
                                  (Superintendent of Documents No. HE 22.8/18)
----------------------------------------------------------------------------------------------------------------
55                                            <bulle  Eligibility and Coverage
                                                  t
                                                      Eligibility Requirements
                                                      Use of Election Periods
                                                      Election, Revocation and Change of Hospice
                                                      Covered Services
                                                      Core Services
                                                      Special Coverage Requirements
                                                      Notice of Election
                                                      Hospice Payment Rates
                                                      Local Adjustment of Payment Rates
                                                      Cap on Overall Reimbursement
                                                      Adjustments to Cap Amount
----------------------------------------------------------------------------------------------------------------
                                             Coverage Issues Manual
                                                  (HCFA Pub. 6)
                                  (Superintendent of Documents No. HE 22.8/14)
----------------------------------------------------------------------------------------------------------------
118                                           <bulle  Enhanced External Counterpulsation for Severe Angina
                                                  t
119                                           <bulle  Pancreas Transplants
                                                  t
----------------------------------------------------------------------------------------------------------------
                                      Provider Reimbursement Manual--Part 1
                                                (HCFA Pub. 15-1)
                                   (Superintendent of Documents No. HE 22.8/4)
----------------------------------------------------------------------------------------------------------------
409                                           <bulle  Travel Expense
                                                  t
----------------------------------------------------------------------------------------------------------------
                                      Provider Reimbursement Manual--Part 2
                                 Provider Cost Reporting Forms and Instructions
                                          Chapter 18--Form HCFA-2088-92
                                               (HCFA Pub. 15-2-18)
                                   (Superintendent of Documents No. HE 22.8/4)
----------------------------------------------------------------------------------------------------------------
3                                             <bulle  Outpatient Rehabilitation Provider Cost Reporting Form
                                                  t
----------------------------------------------------------------------------------------------------------------
                                      Provider Reimbursement Manual--Part 2
                                 Provider Cost Reporting Forms and Instructions
                                          Chapter 32--Form HCFA-1728-94
                                               (HCFA Pub. 15-2-32)
                                   (Superintendent of Documents No. HE 22.8/4)
----------------------------------------------------------------------------------------------------------------
7                                             <bulle  Home Health Agency Cost Reporting Form
                                                  t
                                                      Electronic Reporting Specifications
----------------------------------------------------------------------------------------------------------------
                                      Provider Reimbursement Manual--Part 2
                                 Provider Cost Reporting Forms and Instructions
                                          Chapter 35--Form HCFA-2540-96
                                               (HCFA Pub. 15-2-35)
                                   (Superintendent of Documents No. HE 22.8/4)
----------------------------------------------------------------------------------------------------------------
5                                             <bulle  Skilled Nursing Facility Cost Reporting Form
                                                  t
                                                      Skilled Nursing Facility Complex Cost Reporting Form
----------------------------------------------------------------------------------------------------------------
                                                Medicare/Medicaid
                                         Sanction--Reinstatement Report
                                                 (HCFA Pub. 69)
----------------------------------------------------------------------------------------------------------------
99-7                                          <bulle  Report of Physicians/Practitioners, Providers and/or Other
                                                  t    Health Care Suppliers Excluded/Reinstated--June 1999
99-8                                          <bulle  Report of Physicians/Practitioners, Providers and/or Other
                                                  t    Health Care Suppliers Excluded/Reinstated--July 1999
99-9                                          <bulle  Report of Physicians/Practitioners, Providers and/or Other
                                                  t    Health Care Suppliers Excluded/Reinstated--August 1999
----------------------------------------------------------------------------------------------------------------


[[Page 34487]]


                                          Addendum IV.--Regulation Documents Published in the Federal Register
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                              End of
    Publication date        FR Vol. 64          CFR* part(s)                File code**              Regulation title         comment     Effective date
                               page                                                                                           period
--------------------------------------------------------------------------------------------------------------------------------------------------------
07/02/99................     36069-36089  482....................  HCFA-3018-IFC                 Medicare and Medicaid          08/31/99        08/02/99
                                                                                                  Programs; Hospital
                                                                                                  Conditions of
                                                                                                  Participation:
                                                                                                  Patients' Rights.
07/06/99................     36320-36321  409, 410, 411, 412,      HCFA-1005-4N                  Medicare Program;              07/30/99
                                           413, 419, 489, 498,                                    Prospective Payment
                                           and 1003.                                              System for Hospital
                                                                                                  Outpatient Services;
                                                                                                  Extension of Comment
                                                                                                  Period.
07/06/99................     36321-36322  416 and 488............  HCFA-1885-6N                  Medicare Program;              07/30/99
                                                                                                  Update of Ratesetting
                                                                                                  Methodology, Payment
                                                                                                  Rates, Payment
                                                                                                  Policies, and the List
                                                                                                  of Covered Procedures
                                                                                                  for Ambulatory
                                                                                                  Surgical Centers
                                                                                                  Effective October 1,
                                                                                                  1998; Extension of
                                                                                                  Comment Period.
07/07/99................     36695-36696  .......................  HCFA-1082-N                   Medicare Program; July
                                                                                                  22, 1999, Meeting of
                                                                                                  the Competitive
                                                                                                  Pricing Advisory
                                                                                                  Committee and the Area
                                                                                                  Advisory Committee for
                                                                                                  the Kansas City
                                                                                                  Metropolitan.
07/16/99................     38395-38396  405....................  HCFA-1083-N                   Medicare Program;
                                                                                                  Meetings of the
                                                                                                  Negotiated Rulemaking
                                                                                                  Committee on Ambulance
                                                                                                  Fee Schedule.
07/22/99................     39608-39771  410, 411, 414, and 415.  HCFA-1065-P                   Medicare Program;              09/20/99
                                                                                                  Revisions to Payment
                                                                                                  Policies Under the
                                                                                                  Physician Fee Schedule
                                                                                                  for Calendar Year 2000.
07/23/99................     39934-39938  431 and 498............  HCFA-2054-IFC                 Medicare and Medicaid          09/21/99        07/23/99
                                                                                                  Program; Appeal of the
                                                                                                  Loss of Nurse Aide
                                                                                                  Training Programs.
07/27/99................     40534-40539  414....................  HCFA-1010-P                   Medicare Program;              09/27/99
                                                                                                  Replacement of
                                                                                                  Reasonable Charge
                                                                                                  Methodology by Fee
                                                                                                  Schedules.
07/30/99................     41489-41641  412, 413, 483, and 485.  HCFA-1053-F                   Medicare Program;              10/01/99
                                                                                                  Changes to the
                                                                                                  Hospital Inpatient
                                                                                                  Prospective Payment
                                                                                                  Systems and Fiscal
                                                                                                  Year 2000 Rates.
07/30/99................     41684-41701  .......................  HCFA-1056-N                   Medicare Program;        ..............        10/01/99
                                                                                                  Prospective Payment
                                                                                                  System and
                                                                                                  Consolidated Billing
                                                                                                  for Skilled Nursing
                                                                                                  Facilities--Update.
07/30/99................     41643-41683  409, 411, 413, and 489.  HCFA-1913-F                   Medicare Program;        ..............        09/28/99
                                                                                                  Prospective Payment
                                                                                                  System and
                                                                                                  Consolidated Billing
                                                                                                  for Skilled Nursing
                                                                                                  Facilities.
08/03/99................     42139-42140  .......................  HCFA-3021-N                   Medicare Program;
                                                                                                  August 31, 1999 Open
                                                                                                  Town Hall Meeting To
                                                                                                  Discuss the End Stage
                                                                                                  Renal Disease Network
                                                                                                  Organizations (ESRD
                                                                                                  Networks) Activities.
08/04/99................     42393-42402  .......................  HCFA-1054-N                   Medicare Program;        ..............        10/01/99
                                                                                                  Hospice Wage Index.
08/04/99................     42403-42406  .......................  HCFA-0002-N                   Medicare Program; Year
                                                                                                  2000 Readiness Letters.
08/05/99................     42610-42614  413....................  HCFA-1883-F                   Medicare Program;        ..............        09/07/99
                                                                                                  Revision of the
                                                                                                  Procedures for
                                                                                                  Requesting Exceptions
                                                                                                  to Cost Limits for
                                                                                                  Skilled Nursing
                                                                                                  Facilities and
                                                                                                  Elimination of
                                                                                                  Reclassifications.

[[Page 34488]]

 
08/05/99................     42766-42789  .......................  HCFA-1060-NC                  Medicare Program;              10/04/99    10/01/99 and
                                                                                                  Schedules of Per-Visit                        10/01/00
                                                                                                  and Per-Beneficiary
                                                                                                  Limitations on Home
                                                                                                  Health Agency Costs
                                                                                                  for Cost Reporting
                                                                                                  Periods Beginning on
                                                                                                  or After October 1,
                                                                                                  1999 and Portions of
                                                                                                  Cost Reporting Periods
                                                                                                  Beginning Before
                                                                                                  October 1, 2000.
08/09/99................     43198-43200  .......................  HCFA-1055-NC                  Medicare and Medicaid          10/08/99
                                                                                                  Programs; Announcement
                                                                                                  of Additional
                                                                                                  Applications From
                                                                                                  Hospitals Requesting
                                                                                                  Waivers for Organ
                                                                                                  Procurement Service
                                                                                                  Areas.
08/10/99................           43295  498....................  HCFA-2054-CN                  Medicare and Medicaid    ..............        07/23/99
                                                                                                  Program; Appeal of the
                                                                                                  Loss of Nurse Aide
                                                                                                  Training Programs;
                                                                                                  Correction.
08/10/99................     43338-43339  Chapter IV.............  HCFA-3250-N3                  Medicare Program;
                                                                                                  Negotiated Rulemaking;
                                                                                                  Coverage and
                                                                                                  Administrative
                                                                                                  Policies for Clinical
                                                                                                  Diagnostic Laboratory
                                                                                                  Tests; Announcement of
                                                                                                  Additional Public
                                                                                                  Meetings.
08/18/99................     44841-44856  413....................  HCFA-1001-IFC                 Medicare Program;              10/18/99        09/17/99
                                                                                                  Graduate Medical
                                                                                                  Education (GME):
                                                                                                  Incentive Payments
                                                                                                  Under Plans for
                                                                                                  Voluntary Reduction in
                                                                                                  the Number of
                                                                                                  Residents.
08/20/99................     45785-45807  45 CFR 144, 146, 148,    HCFA-2019-IFC                 Federal Enforcement in         10/19/99        09/20/99
                                           and 150.                                               Group and Individual
                                                                                                  Health Insurance
                                                                                                  Markets.
08/24/99................     46205-46206  .......................  HCFA-1076-N                   Medicare Program;
                                                                                                  September 16, 1999,
                                                                                                  Meeting of the
                                                                                                  Competitive Pricing
                                                                                                  Advisory Committee.
08/27/99................           46920  .......................  HCFA-1077-N                   Medicare Program;
                                                                                                  September 23, 1999,
                                                                                                  Meeting of the
                                                                                                  Competitive Pricing
                                                                                                  Demonstration Area
                                                                                                  Advisory Committee,
                                                                                                  Maricopa County.
09/07/99................           48661  .......................  HCFA-1078-N                   Medicare Program;
                                                                                                  September 27 and 28,
                                                                                                  1999, Meeting of the
                                                                                                  Practicing Physicians
                                                                                                  Advisory Council.
09/09/99................     49020-49021  .......................  HCFA-1087-N                   Medicare Program; Open
                                                                                                  Public Meeting To
                                                                                                  Discuss the Conduct of
                                                                                                  a Second Competitive
                                                                                                  Bidding Demonstration.
09/10/99................     49199-49201  .......................  HCFA-2057-PN                  Medicare and Medicaid          10/12/99
                                                                                                  Programs;
                                                                                                  Reapplication of the
                                                                                                  American Osteopathic
                                                                                                  Association (AOA) for
                                                                                                  Continued Approval of
                                                                                                  Deeming Authority for
                                                                                                  Hospitals.
09/10/99................     49197-49198  .......................  HCFA-2058-PN                  Medicare and Medicaid          10/12/99
                                                                                                  Programs; Application
                                                                                                  of the Joint
                                                                                                  Commission for
                                                                                                  Accreditation of
                                                                                                  Healthcare
                                                                                                  Organizations (JCAHO)
                                                                                                  for Continued Approval
                                                                                                  of Deeming Authority
                                                                                                  for Home Health
                                                                                                  Agencies.
09/10/99................     49121-49128  435, 436, and 440......  HCFA-2082-N                   Medicaid Program;              11/09/99
                                                                                                  Optional Coverage of
                                                                                                  Certain Tuberculosis-
                                                                                                  Related Services to TB-
                                                                                                  Infected Individuals.

[[Page 34489]]

 
09/16/99................           50288  .......................  HCFA-1039-CN2                 Medicare Program;        ..............        10/01/99
                                                                                                  Hospice Wage Index;
                                                                                                  Correction.
09/17/99................     50482-50483  405....................  HCFA-1086-N                   Medicare Program;
                                                                                                  Meetings of the
                                                                                                  Negotiated Rulemaking
                                                                                                  Committee on the
                                                                                                  Ambulance Fee Schedule.
09/17/99................     50523-50524  .......................  HCFA-1090-N                   Medicare Program;
                                                                                                  October 6, 1999 and
                                                                                                  November 15, 1999,
                                                                                                  Meetings of the
                                                                                                  Competitive Pricing
                                                                                                  Demonstration Area
                                                                                                  Advisory Committee,
                                                                                                  Kansas City, MO
                                                                                                  Metropolitan Area.
09/27/99................     51908-51910  413....................  HCFA-1876-F                   Medicare Program;        ..............        11/26/99
                                                                                                  Revision to Accrual
                                                                                                  Basis of Accounting
                                                                                                  Policy.
09/28/99................           52377  .......................  HCFA-1054-N                   Medicare Program;
                                                                                                  Hospice Wage Index.
09/30/99................     52665-52670  405....................  HCFA-4121-FC                  Medicare Program;              11/29/99       02/01/00
                                                                                                  Telephone Requests for
                                                                                                  Review of Part B
                                                                                                  Initial Claim
                                                                                                  Determinations.
--------------------------------------------------------------------------------------------------------------------------------------------------------
*42 CFR except where noted
**N--General Notice; PN--Proposed Notice; NC--Notice with Comment Period; FN--Final Notice; P--Notice of Proposed Rulemaking (NPRM); F--Final Rule; FC--
  Final Rule with Comment Period; CN--Correction Notice; IFC--Interim Final Rule with Comment Period; GNC--General Notice with Comment Period

Addendum V--Categorization of Food and Drug Administration-Allowed 
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.

G 990077--A2
G 990162--A1
G 990169--A2

    The following information presents the device number, category 
(in this case, B), and criterion code.

G 980325--B3
G 990123--B1
G 990124--B4
G 990125--B2
G 990127--B4
G 990131--B3
G 990132--B2
G 990134--B4
G 990137--B1
G 990138--B5
G 990139--B3
G 990142--B4
G 990143--B3
G 990144--B2
G 990146--B2
G 990148--B4
G 990150--B3
G 990151--B2
G 990152--B2
G 990153--B4
G 990155--B2
G 990156--B2
G 990158--B3
G 990164--B4
G 990171--B1
G 990172--B2
G 990174--B4
G 990175--B2
G 990176--B4
G 990177--B4
G 990178--B2
G 990179--B
G 990181--B4
G 990183--B4
G 990185--B3
G 990189--B3
G 990192--B1
G 990194--B4
G 990197--B4
G 990199--B4
G 990207--B2
G 990209--B4

[FR Doc. 00-13347 Filed 5-26-00; 8:45 am]
BILLING CODE 4120-03-U