[Federal Register Volume 64, Number 234 (Tuesday, December 7, 1999)]
[Notices]
[Pages 68357-68364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-31601]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration
[HCFA-9004-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--First 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 January, February, and March of 1999, relating to the 
Medicare and Medicaid programs. It 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

[[Page 68358]]

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-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 (FDA) 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 FDA 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/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).

[[Page 68359]]

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, 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.
    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 (HCFA Pub. 13-3) transmittal entitled 
``Mammography Screening,'' use the Superintendent of Documents No. HE 
22.8/6 and the HCFA transmittal number 1754.

(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 18, 1999.
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)

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 (January 
1999 Through March 1999)

Transmittal No. and Manual/Subject/Publication Number

Intermediary Manual Part 3--Claims Process (HCFA Pub. 13-3) 
(Superintendent of Documents No. HE 22.8/6)
1766
     File specifications, Records Specifications, and Data 
Element Definitions for Electronic Media Claims Bills.
1767
     Model Development Letter Questions.
1768
     Bed-Hold Policies for Long-Term Care Facilities.
1769
     Medicare Rural Hospital Flexibility Program.
    Grand fathering Existing Facilities.
    Requirements for Critical Access Hospital Services and Critical 
Access Hospital Long-term Care Services.
    Payment for Services Furnished by a Critical Access Hospital.
    Payment for Post-Hospital Skilled Nursing Facilities Care Furnished 
by a Critical Access Hospital.
    Review of Form HCFA-1450 for the Inpatient.
1770
     Comprehensive Medical Review Procedures Using Statistical 
Sampling for Overpayment Estimation.
1771
     Oral Anti-Nausea Drugs as Full Therapeutic Replacements 
for Intravenous Dosage Forms as Part of a Cancer Chemotherapeutic 
Regimen.
1772
     Coding for Adequacy of Hemodialysis.
Carriers Manual Part 3--Claims Process (HCFA Pub. 14-3) (Superintendent 
of Documents No. HE 22.8/7)
1624
     Self-Administered Drugs and Biologicals.
1625
     Identifying a Screening Mammography Claim.
1626
     Requirements for Processing Electronic Media Claims.
1627
     Requirements for Processing Electronic Media Claims.
1628
     Payment for Oral Anti-Emetic Drugs When Used as Full 
Replacement for Intravenous Anti-Emetic Drugs as Part of a Cancer 
Chemotherapeutic Regimen.
1629
     General Claims Processing Requirements.
1630
     Type of Service.
Carriers Manual Part 4--Professional Relations (HCFA Pub. 14-4) 
(Superintendent of Documents No. HE 22.8/7)
19

[[Page 68360]]

     Registry of Physicians/Health Care Practitioners/Group 
Practices.
    Ongoing Data Collection on Physicians/Health Care Practitioners/
Group Practices Applications.
    Physician/Health Care Practitioners/Group Practices Record-Required 
Information and Format.
    Maintaining Physician/Health Care and Practitioner/Group Practices 
Memberships.
    Update Records.
    Batching Procedures.
    Privacy Act Requirements.
    Physician Opted Out.
    Carrier Record Requirements.
    Unique Physician Identification Number Carrier Record Layout.
20
     Enrollment Instructions.
    HCFA-855 R, Individual Reassignment of Benefits.
    Enrolling Certified Providers/Suppliers Who Enroll with Carriers.
Program Memorandum Intermediaries (HCFA Pub. 60A) (Superintendent of 
Documents No. HE 22.8/6-5)
A-99-1
     Clarification of the Implementation of Sec. 510(a)(3) of 
the Omnibus Consolidated and Emergency Supplemental Appropriation Act, 
Fiscal Year 1999 Enacted on October 21, 1998 and the Wage Indices 
Applicable to Guam and the Virgin Islands.
A-99-2
     Hospital Outpatient Procedures: Billing for Contrast 
Material (Clarification).
A-99-3
     Hospital Outpatient Procedures: Medicare Changes for 
Radiology and Other Diagnostic Coding Due to the 1998 HCFA Common 
Procedures Coding System Update; Miscellaneous Changes.
A-99-4
     Hepatitis C Virus Look Back.
A-99-5
     Claims Processing Instructions for the National Institutes 
of Health National Emphysema Treatment.
A-99-6
     Information Requirements for Home Health Services--15 
Minute Increment Reporting.
A-99-7
     Extension of Due Date for Filing Provider Cost Reports.
A-99-8
     Policy Clarification and Guidance for Services Furnished 
by Rural Health Clinics and Federally Qualified Health Centers and 
Announcement of Medicare Federally Qualified Health Centers and Rural 
Health Clinics Payment Rate Increases.
A-99-9
     Interim Rate Changes Due to the Elimination of the Formula 
Driven Overpayment.
A-99-10
     Rural Health Clinics and Federally Qualified Health 
Centers Provisions Enacted by Sec. 4205 of the Balanced Budget Act of 
1997.
A-99-11
     Clarification of Provider Cost Report Filing Requirements.
A-99-12
     Medicare Home Health Benefit--Sec. 4615 of the Balanced 
Budget Act of 1997; Clarification That No Home Health Benefits are 
Authorized Based Solely on Drawing Blood.
Program Memorandum Carriers (HCFA Pub. 60B) (Superintendent of 
Documents No. HE 22.8/6-5)
B-99-1
     Evaluating the Medical Necessity for Laboratory Panel 
Current Procedural Terminology Codes.
B-99-2
     Payment for Teleconsultations in Rural Health Professional 
Shortage Areas.
B-99-3
     Revisions to Transmittal No. AB-98-14 Dated April 1998 
``Claims Processing Instructions for the National Institutes of Health 
National Emphysema Treatment Trial.''
B-99-4
     Standard System Acceptance of Primary Payer Information at 
the Line Level.
B-99-5
     Changes to the 1999 Medicare Physician Fee Schedule 
Database.
B-99-6
     Matrix to Complete Provider/Supplier Enrollment 
Application (Form HCFA-855).
B-99-7
     Millennium Changes for Forms HCFA-1491, 1490S, and 1490U.
B-99-8
     Health Professional Shortage Area Bonus Payment 
Clarification.
B-99-9
     Change to Health Insurance Claim Form HCFA-1500 
Instructions for Processing Physician Claims in Global Payment Systems.
B-99-10
     Durable Medical Equipment Carrier Billing Procedures.
B-99-11
     Modifications to Form HCFA-1500 Instructions.
B-99-12
     Paramedic Intercept Provisions of the Balanced Budget Act 
of 1997.
Program Memorandum Intermediaries/Carriers (HCFA Pub. 60A/B) 
(Superintendent of Documents No. HE 22.8/6-5)
AB-99-1
     Activating Y2K ``Return as Unprocessable'' Edits for Paper 
and Electronic Media Claims.
AB-99-2
     Updates to the Mammography Quality Standards Act Record 
File Layout for Y2K Compliance.
AB-99-3
     Ending Suppression of Explanation of Medicare Benefits and 
Medicare Summary Notices for All Claim Types Except: Laboratory, 
Demonstrations, Exact Duplicates, and Statistical Adjustments.
AB-99-4
     Interim Claims Processing Instructions for Payment for 
Oral Anti-Emetic Drugs When Used as Full Replacement for Intravenous 
Anti-Emetic Drugs as Part of a Cancer Chemotherapeutic Regimen.
AB-99-5
     Instructions for Implementing and Tracking the Medicare 
Fraud and Abuse Incentive Reward Program.
AB-99-6
     Notice of New Interest Rates for Medicare Overpayments and 
Underpayments.
AB-99-7
     Notification to Medicare Providers and Suppliers of 
Beneficiary Right to an Itemized Statement.
AB-99-8
     Provider Outreach Activities Specific to Y2K Awareness.
AB-99-9
     Implementation of the Office of the Inspector General's 
Fraud Hot Line Number on Medicare Beneficiary Notices.
AB-99-10
     Provider Overpayment Recovery Physicians Supplier 
Overpayment Recovery Systems Overpayments Transferred to the Debt 
Collection Center for Cross Servicing.
AB-99-11
     Consolidated Billing for Skilled Nursing Facilities.
Program Memorandum Medicaid State Agencies (HCFA Pub. 17) 
(Superintendent of Documents No. HE 22.8/6-5)
99-1
     Title XIX of the Social Security Act, Post-Eligibility 
Treatment of Income.

[[Page 68361]]

State Operations Manual Provider Certification (HCFA Pub. 7) 
(Superintendent of Documents No. HE 22.8/12)
5
     Conducting Initial Surveys and Scheduled Resurveys.
    Unannounced Surveys.
    Survey Protocol for Long Term Care Facilities.
6
     Sanctions for Intermediate Care Facilities/Mental 
Retardation for Non-Immediate Jeopardy.
    Directed Plan of Correction.
    Directed In-Service Training.
    State Monitoring.
    Achieving Continuous Substantial Compliance.
    Criteria for Review of State Plans for Approval or Disapproval of 
Alternative Sanctions.
7
     Survey Procedures and Interpretive Guidelines for 
Laboratories and Laboratory Services.
Peer Review Organization Manual (HCFA Pub. 19) (Superintendent of 
Documents No. HE 22.8/8-15)
69
     Introduction.
    HCFA/Office of Clinical Standards and Quality Requirements.
    Statutory and Regulatory Requirements.
    Definitions.
    Office of Management and Budget Clearance.
    Items Not Subject to Office of Management and Budget Clearance.
    Request for Exception from Office of Management and Budget Review.
    Survey Justification and Methods.
    Additional Considerations.
    Documentation for HCFA.
70
     Introduction.
    Anti-Dumping Violations.
    Assistants at Cataract Surgery.
    Beneficiary Complaints.
    Hospital and Managed Care Plan Notices of Noncoverage.
    Hospital-Requested Higher-Weighted Diagnostic Related Group 
Assignments.
    Potential Concerns Identified During Project Data Collection.
    Referrals.
    Quality Review.
    Admission Review.
    Invasive Procedure Review.
    Length-of-Stay Review.
    Coverage Review.
    Diagnostic Related Group Validation Review.
    Discharge Review.
    Day and Cost Outlier Review.
    Ambulatory Surgery Review.
    Limitation on Liability Determinations.
    Readmission Review.
    Transfer Review.
    Non-physician Review.
    First Level Physician Review.
    Action Following Opportunity for Discussion.
    Second Level Physician Review.
    Third Level Physician Review.
    Use of the Physician Reviewer Assessment Format.
    Review of Medicare Services.
    Review Settings.
    Using Screening Criteria.
    Requesting Medical Records/Reviewing Documentation.
    Providing Opportunity for Discussion.
    Adhering to Review Time Frames.
    Profiling Case Review Results.
    Maintaining Memoranda of Agreements.
    Monitoring an Important Message from Medicare.
    Monitoring Hospitals' Physician Acknowledgment Statements.
    Non-physician Reviewers.
    Physician Reviews.
    Health Care Practitioners Other Than Physicians.
    Conflict of Interest.
    Training.
71
     Quality Review--Overview.
    Determination of Source of Concerns.
    Notification of Quality Concerns to Affected Parties.
    Peer Review Organization Quality Improvement Activities.
    Peer Review Organization Review Reporting Requirements.
    Scope of Review.
    Complaints That Do Not Meet Statutory Requirements.
    Referrals.
    Review Process.
    Notice of Disclosure.
    Disclosure of Quality Review Information to Complainants.
    Data Analysis and Reporting Requirements.
    Peer Review Organization Review Responsibilities.
    Actions to be Taken by Peer Review Organizations.
Hospital Manual (HCFA Pub. 10) (Superintendent of Documents No. HE 
22.8/2)
739
     Identifying Other Primary Payers During the Admission 
Process.
    Admission Questions to Ask Medicare Beneficiaries.
740
     Medicare Rural Hospital Flexibility Program.
    Grandfathering Existing Facilities.
    Requirements for Critical Access Hospital Services and Critical 
Access Hospital Long-term Care Services.
    Payment for Services Furnished by a Critical Access Hospital.
    Payment for Post-Hospital Skilled Nursing Facilities Care. 
Furnished by a Critical Access Hospital.
    Review of Form HCFA-1450 for the Inpatient.
741
     Coding for Adequacy of Hemodialysis.
Religious Nonmedical Health Care Institutions (Hospital Manual 
Supplement) (HCFA Pub. 32) (Superintendent of Documents No. HE 22.8/2-
2)
41
     Claims Processing Timeliness.
Home Health Agency Manual (HCFA Pub. 11) (Superintendent of Documents 
No. HE 22.8/5)
290
     Claims Processing Timeliness.
Skilled Nursing Facility Manual (HCFA Pub. 12) (Superintendent of 
Documents No. HE 22.8/3)
358
     Completion of Form HCFA-1450 for Inpatient and/or 
Outpatient Billing.
    Provider Electronic Billing File and Record Formats.
    Alphabetic Listing of Data Elements.
359
     Claims Processing Timeliness.
Rural Health Clinic and Federally Qualified Health Centers Manual (HCFA 
Pub. 27) (Superintendent of Documents No. HE 22.8/19:985)
33
     Claims Processing Timeliness.
Renal Dialysis Facility Manual (Non-Hospital Operated) (HCFA Pub. 29) 
(Superintendent of Documents No. HE 22.8/13)
84
     Completion of Form HCFA-1450 by Independent Facilities for 
Home Dialysis Items and Services Billed Under the Composite Rate Method 
I.
85
     Claims Processing Timeliness.
86
     Coding for Adequacy of Hemodialysis.
Hospice Manual (HCFA Pub. 21) (Superintendent of Documents No. HE 22.8/
18)
54

[[Page 68362]]

     Claims Processing Timeliness.
Outpatient Physical Therapy, Comprehensive Outpatient Rehabilitation 
Facility and Community Mental Health Center Manual (HCFA Pub. 9) 
(Superintendent of Documents No. HE 22.8/9)
6
     Claims Processing Timeliness.
Coverage Issues Manual (HCFA Pub. 6) (Superintendent of Documents No. 
HE 22.8/14)
106
     Positron Emission Tomography Scans.
107
     Durable Medical Equipment Reference List.
108
     Abortion.
Provider Reimbursement Manual--Part 1 (HCFA Pub. 15-1) (Superintendent 
of Documents No. HE 22.8/4)
408
     Travel Expense.
    Effective Date of Change in Size of Participating Skilled Nursing 
Facility.
    Effective Date of Change in Size at Beginning of Cost Reporting 
Quarter of Provider Following Approval by Regional Office.
    Exceptions.
409
     Effective Date of Change in Size of Participating Skilled 
Nursing Facility.
    Effective Date of Change in Size at Beginning of Cost Reporting 
Quarter of Provider Following Approval by Regional Office Exceptions.
State Medicaid Manual Part 4--Services (HCFA Pub. 45-4) Superintendent 
of Documents No. HE 22.8/10
72
     Personal Care Services.
Medicare/Medicaid Sanction--Reinstatement Report (HCFA Pub. 69)
99-1
     Report of Physicians/Practitioners, Providers and/or Other 
Health Care Suppliers Excluded/Reinstated-December 1998.
99-2
     Report of Physicians/Practitioners, Providers and/or Other 
Health Care Suppliers Excluded/Reinstated-January 1999.

                      Addendum IV.--Regulation Documents Published in the Federal Register
----------------------------------------------------------------------------------------------------------------
                                                                                           End of
Publication    FR Vol. 64      CFR* part(s)       File code**       Regulation title      comment     Effective
    date          page                                                                     period        date
----------------------------------------------------------------------------------------------------------------
   01/04/99              69  Chapter IV......  HCFA-3250-N2.....  Medicare Program;     ...........  ...........
                                                                   Negotiated
                                                                   Rulemaking;
                                                                   Coverage and
                                                                   Administrative
                                                                   Policies for
                                                                   Clinical Diagnostic
                                                                   Laboratory Tests;
                                                                   Announcement of
                                                                   Additional Public
                                                                   Meetings.
   01/04/99         170-171  ................  HCFA-3889-N......  Medicare Program;     ...........  ...........
                                                                   Open Town Hall
                                                                   Meeting to Discuss
                                                                   the Positron
                                                                   Emission Tomography.
   01/12/99       1784-1785  409, 410, 411,    HCFA-1005-2N.....  Medicare Program;        03/09/99  ...........
                              412, 413, 419,                       Prospective Payment
                              489, 498, and                        System for Hospital
                              1003.                                Outpatient
                                                                   Services; Extension
                                                                   Of Comment Period.
   01/12/99       1785-1786  416 and 488.....  HCFA-1885-4N.....  Medicare Program;        03/09/99  ...........
                                                                   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.
   01/22/99       3474-3478  405.............  HCFA-1002-NOI....  Medicare Program;        02/22/99  ...........
                                                                   Ambulance Fee
                                                                   Schedule; Intent to
                                                                   Form Negotiated
                                                                   Rulemaking
                                                                   Committee.
   01/25/99       3637-3650  409, 410, and     HCFA-1813-FC.....  Medicare Program;        03/26/99     02/24/99
                              424.                                 Coverage of
                                                                   Ambulance Services
                                                                   and Vehicle and
                                                                   Staff Requirements.
   01/25/99       3748-3763  484 and 488.....  HCFA-3006-IFC....  Medicare and             03/26/99     02/24/99
                                                                   Medicaid Programs;
                                                                   Reporting Outcome
                                                                   and Assessment
                                                                   Information Set
                                                                   (OASIS) Data as
                                                                   Part of the
                                                                   Conditions of
                                                                   Participation for
                                                                   Home Health
                                                                   Agencies.
   01/25/99       3764-3784  484.............  HCFA-3007-F......  Medicare and          ...........     02/24/99
                                                                   Medicaid Programs;
                                                                   Comprehensive
                                                                   Assessment and Use
                                                                   of the OASIS as
                                                                   Part of the
                                                                   Conditions of
                                                                   Participation for
                                                                   Home Health
                                                                   Agencies.
   02/04/99       5667-5668  ................  HCFA-0001-N......  Medicare Program;     ...........  ...........
                                                                   Year 2000 Readiness
                                                                   Letter.

[[Page 68363]]

 
   02/08/99       6102-6108  ................  HCFA-2014-N......  State Children's      ...........  ...........
                                                                   Health Insurance
                                                                   Program; Reserved
                                                                   Allotments to
                                                                   States for Fiscal
                                                                   Year 1999 and
                                                                   Revised Reserved
                                                                   Allotments to
                                                                   States for Fiscal
                                                                   Year 1998.
   02/11/99       6827-6852  410, 414, 424,    HCFA-3002-P......  Medicare Program;        04/12/99  ...........
                              476, and 498.                        Expanded Coverage
                                                                   for Outpatient
                                                                   Diabetes Self-
                                                                   Management Training
                                                                   Services.
   02/12/99       7198-7199  ................  HCFA-1064-N......  Medicare Program;     ...........  ...........
                                                                   March 15, 1999,
                                                                   Meeting of the
                                                                   Practicing
                                                                   Physicians Advisory
                                                                   Council.
   02/17/99       7968-7982  422.............  HCFA-1030-F......  Medicare Program;     ...........     03/19/99
                                                                   Changes to the
                                                                   Medicare+Choice
                                                                   Program.
   02/17/99       7899-7900  ................  HCFA-4008-N......  Medicare Program;     ...........  ...........
                                                                   Establishment of
                                                                   the Citizens
                                                                   Advisory Panel on
                                                                   Medicare Education
                                                                   and Requests for
                                                                   Nominations for
                                                                   Members.
   02/25/99       9378-9399  412.............  HCFA-1049-F......  Medicare Program;     ...........     03/01/99
                                                                   Changes to the
                                                                   Fiscal Year 1999
                                                                   Hospital Inpatient
                                                                   Prospective Payment
                                                                   Wage Index and
                                                                   Standardized
                                                                   Amounts Resulting
                                                                   From Approved
                                                                   Requests for Wage
                                                                   Data Revisions.
   03/04/99     10479-10480  ................  HCFA-2041-N......  Medicaid Program;     ...........     02/25/99
                                                                   Decision on Funding
                                                                   for the AIDS
                                                                   Healthcare
                                                                   Foundation START
                                                                   Program.
   03/11/99     12172-12173  ................  CFA-1068-N.......  Medicare Program;     ...........  ...........
                                                                   Meetings of the
                                                                   Competitive Pricing
                                                                   Demonstration Area
                                                                   Advisory Committee,
                                                                   Kansas City
                                                                   Metropolitan Area.
   03/11/99           12173  ................  HCFA-1101-N......  Medicare Program;     ...........  ...........
                                                                   Meetings of the
                                                                   Competitive Pricing
                                                                   Demonstration Area
                                                                   Advisory Committee,
                                                                   Maricopa County, AZ.
   03/12/99     12277-12278  409, 410, 411,    HCFA-1005-3N.....  Medicare Program;        06/30/99  ...........
                              412, 413, 419,                       Prospective Payment
                              489, 498, and                        System for Hospital
                              1003.                                Outpatient
                                                                   Services; Extension
                                                                   of Comment Period.
   03/12/99     12278-12279  416 and 488.....  HCFA-1885-5N.....  Medicare Program;        06/30/99  ...........
                                                                   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.
   03/12/99           12404  ................  HCFA-2014-N......  State Children's      ...........  ...........
                                                                   Health Insurance
                                                                   Program; Reserved
                                                                   Allotments to
                                                                   States for Fiscal
                                                                   Year 1999 and
                                                                   Revised Reserved
                                                                   Allotments to
                                                                   States for Fiscal
                                                                   Year 1998.
   03/18/99     13354-13362  488.............  HCFA-2035-FC.....  Medicare and             05/17/99     05/17/99
                                                                   Medicaid Programs;
                                                                   Civil Money
                                                                   Penalties for
                                                                   Nursing Homes (SNF/
                                                                   NF), Change in
                                                                   Notice
                                                                   Requirements, and
                                                                   Expansion of
                                                                   Discretionary
                                                                   Remedy Delegation.
   03/23/99     13998-13999  ................  HCFA-1100-N......  Medicare Program;        06/21/99  ...........
                                                                   Medicare
                                                                   Coordinated Care
                                                                   Demonstration
                                                                   Project and Request
                                                                   for Information on
                                                                   Potential Best
                                                                   Practices of
                                                                   Coordinated Care.

[[Page 68364]]

 
   03/26/99           14666  405.............  HCFA-1002-N......  Medicare Program;     ...........  ...........
                                                                   Meetings of the
                                                                   Negotiated
                                                                   Rulemaking
                                                                   Committee on
                                                                   Ambulance Fee
                                                                   Schedule.
   03/29/99     14931-14934  ................  HCFA-2032-N......  Medicare Program;     ...........    10/01/98
                                                                   State Allotments
                                                                   for Payment of
                                                                   Medicare Part B
                                                                   Premiums for
                                                                   Qualifying
                                                                   Individuals:
                                                                   Federal Fiscal Year
                                                                   1999.
----------------------------------------------------------------------------------------------------------------
* 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.

G980173  A2
G980257  A1
G980263  A1
G980315  A1
G980320  A1
G980330  A2
G990028  A1
G990037  A1
G990043  A2
G990053  A1

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

G980095  B4
G980139  B4
G980143  B2
G980188  B4
G980243  B4
G980254  B4
G980273  B4
G980281  B3
G980307  B4
G980308  B4
G980310  B
G980312  B3
G980313  B4
G980314  B4
G980318  B2
G980319  B4
G980321  B4
G980322  B
G980323  B2
G980324  B4
G980326  B2
G980328  B3
G990004  B4
G990005  B1
G990006  B4
G990010  B4
G990011  B3
G990014  B3
G990016  B5
G990019  B4
G990020  B4
G990022  B2
G990023  B4
G990024  B3
G990026  B2
G990029  B4
G990031  B3
G990035  B1
G990036  B2
G990041  B4
G990042  B4
G990044  B1
G990046  B4
G990050  B2
G990051  B4

[FR Doc. 99-31601 Filed 12-6-99; 8:45 am]
BILLING CODE 4120-01-P