[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]


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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.

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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:
     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 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.
     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).
     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:
     Titles XI, XVIII, and XIX of the Act.
     HCFA-related regulations.
     HCFA manuals and monthly revisions.
     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]
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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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1778