[Federal Register Volume 63, Number 236 (Wednesday, December 9, 1998)]
[Notices]
[Pages 67899-67908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32590]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration
[HCFA-9002-N]
RIN 0938-AI13


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--Second Quarter, 1998

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 April, May, and June of 1998 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 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 timeframe.

FOR FURTHER INFORMATION CONTACT:

Bridgett 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).
Kristy Nishimoto, (410) 786-8517 (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.

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 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) 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

[[Page 67900]]

published HCFA Medicare and Medicaid manuals and memoranda.
    Addendum III 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. It is HCFA's practice to 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, 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/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 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 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 Hospital Manual,

[[Page 67901]]

(HCFA Pub. 10) transmittal entitled ``Claims Processing Timeliness 
Requirements,'' use the Superintendent of Documents No. HE 22.8/2 and 
the HCFA transmittal number 729.

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, S2-26-13, 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 and 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 
Kristy Nishimoto, Office of Communications and Operations Support, 
Division of Regulations and Issuances, Health Care Financing 
Administration, C5-13-07, 7500 Security Boulevard, Baltimore, MD 21244-
1850, Telephone (410) 786-8517.

(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: November 24, 1998.
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.

November 3, 1997 (62 FR 59358)
November 21, 1997 (62 FR 62325)
June 4, 1998 (63 FR 30499)
August 11, 1998 (63 FR 42857)
September 16, 1998 (63 CFR 49598)

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.

        Addendum III.--Medicare and Medicaid Manual Instructions
                     [April 1998 through June 1998]
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    Trans. No.                     Manual/subject/publication No.
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                           Intermediary Manual
          Part 2--Audits, Reimbursement Program Administration
                            (HCFA Pub. 13-2)
             (Superintendent of Documents No. HE 22.8/6-2)
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411