# Medicare and Medicaid Programs; Quarterly Listing of Program IssuancesFirst Quarter, 1998

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/fr%3A98-24804

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** September 16, 1998
- **Citation:** 63 FR 49598

## Text

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration
[HCFA-9879-N]

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

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 January, February, and March 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: Bridget Wilhite, (410) 786-5248 (For
Medicare instruction information);
Betty Stanton, (410) 786-3247 (For Medicaid instruction
information);
Sharon Hippler, (410) 786-4633 (For Food and Drug Administration-
approved investigational device exemption information);
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. Most notably, those unfamiliar with a
description of our Medicare manuals may wish to review Table I of our
first three notices (53 FR 21730, 53 FR 36891, and 53 FR 50577) and the
notice published March 31, 1993 (58 FR 16837), and those desiring
information on the Medicare Coverage Issues Manual may wish to review
the August 21, 1989 publication (54 FR 34555).
To aid the reader, we have organized and divided this current
listing into five addenda. Addendum I lists the publication dates of
the most recent quarterly listings of program issuances.
Addendum II identifies previous Federal Register documents that
contain a description of all previously

[[Page 49599]]

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. 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 Home Health Agency Manual,
(HCFA Pub. 11) transmittal entitled ``Treatment Codes for Home Health
Services,'' use the

[[Page 49600]]

Superintendent of Documents No. HE 22.8/5 and the HCFA transmittal
number 286.

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 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: September 8, 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.

May 12, 1997 (62 FR 25957)
November 3, 1997 (62 FR 59358)
November 21, 1997 (62 FR 62325)
June 4, 1998 (63 FR 30499)
August 11, 1998 (63 FR 42857)

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
[January 1998 Through March 1998]
------------------------------------------------------------------------
Trans. No. Manual/Subject/Publication No.
------------------------------------------------------------------------
Intermediary Manual
Part 3--Claims Process
(HCFA Pub. 13-3)
(Superintendent of Documents No. HE 22.8/6)
------------------------------------------------------------------------
1731 <bulle Reporting Outpatient Surgery and Other
t Services.
Use of Modifiers in Reporting Hospital
Outpatient Services.
1732 <bulle Medicare Secondary Payment Modules.
t
Payment Calculation for Inpatient Bills.
Payment Calculation for Outpatient Bills.
1733 <bulle Definition of Medicare Secondary Payer/Common
t Working File Terms.
1734 <bulle Medical Review of Home Health Services.
t
Home Health Certification and Plan of Care
Data Elements.
Treatment Codes for Home Health Services.
Plan of Care.
Medical Review of Skilled Nursing and Home
Health Aide Hours for Determining Part-Time
or Intermittent.
Treatment Codes for Professional Services
Required.
Acceptable V Codes.
1735 <bulle Pneumococcal Pneumonia, Influenza Virus and
t Hepatitis B Vaccines.
Mammography Screening.
1736 <bulle Eligibility Data Available
t
Part A Eligibility Data Security
Requirements.
------------------------------------------------------------------------
Carriers Manual
Part 3--Claims Process
(HCFA Pub. 14-3)
(Superintendent of Documents No. HE 22.8/7)
------------------------------------------------------------------------
1584 <bulle Medicare Participating Physicians/Suppliers
t Directory.
1585 <bulle Application of Foot Care Exclusions to
t Physicians' Services.
1586 <bulle Medicare Secondary Payment Modules.
t
Payment Calculation for Physician/Supplier
Claims.
1587 <bulle Identifying a Screening Mammography Claim.
t
Medicare Summary Notice and Explanation of
Medicare Benefits Messages.
Remittance Advice Messages.
1588 <bulle Chiropractic Services.
t

[[Page 49601]]

1589 <bulle Medicare Secondary Payer Claims Processing
t Under Common Working File.
1590 <bulle The Carrier Advisory Committee.
t
1591 <bulle Payment for Oral Anti-Emetic Drugs When Used
t as Full Replacement for Intravenous Anti-
Emetic Drugs as Part of a Cancer
Chemotherapeutic Regimen.
1592 <bulle Requirements for Processing Electronic Media
t Claims.
1593 <bulle Definition of a Claim.
t
Splitting Claims for Processing.
1594 <bulle Durable Medical Equipment, Prosthetic, and
t Orthotic Supplies.
Safeguards in Making Monthly Payments.
Evidence of Medical Necessity--Oxygen Claim.
1595 <bulle Claims Review for Global Surgeries.
t
1596 <bulle Positron Emission Tomography Scans.
t
Conditions for Medicare Coverage of Positron
Emission Tomography Scans for Noninvasive
Imaging of the Perfusion of the Heart.
Conditions of Coverage of Positron Emission
Tomography Scans for Characterization of
Solitary Pulmonary Nodules and Positron
Emission Tomography Scans Using FDG to
Initially Stage Lung Cancer.
Billing requirements for Positron Emission
Tomography Scans.
HCFA Common Procedures Coding System and
Modifiers for Positron Emission Tomography
Scans.
Claims Processing Instructions for Positron
Emission Tomography Scan Claims.
------------------------------------------------------------------------
Program Memorandum
Intermediaries (HCFA Pub. 60A)
(Superintendent of Documents No. HE 22.8/6-5)
------------------------------------------------------------------------
A-97-22 <bulle Claims Processing for the Restructured
t Hospice Benefit Periods and Billing
Clarification for Place of Service.
A-98-1 <bulle Processing Claims for the Home Health Part A
t and Part B Shift.
A-98-2 <bulle Developing Medicare Ambulance Rates.
t
A-98-3 <bulle Medicare Home Health Benefit--Section 4615 of
t the Balanced Budget Act of 1997--
Clarification That No Home Health Benefits
are Authorized Based Solely On Drawing
Blood.
A-98-4 <bulle Implementation of Surety Bond Requirement for
t Home Health Agencies.
A-98-5 <bulle Billing Requirements for Claims with Dates of
t Service on or After April 1, 1998 for Oral
Anti-Nausea Drugs as Full Therapeutic
Replacements for Intravenous Dosage Forms As
Part of a Cancer Chemotherapeutic Regimen.
A-98-6 <bulle Screening Pap Smear and Pelvic Examinations--
t The Balanced Budget Act of 1997.
A-98-7 <bulle Extension of Due Date for Filing Provider
t 2552-96 Cost Reports.
A-98-8 <bulle Reporting Outpatient Rehabilitation Services
t and All Comprehensive Outpatient
Rehabilitation Facility Services Using HCFA
Common Procedure Coding System.
A-98-9 <bulle Positron Emission Tomography Scans.
t
------------------------------------------------------------------------
Program Memorandum
Carriers
(HCFA Pub. 60B)
(Superintendent of Documents No. HE 22.8/6-5)
------------------------------------------------------------------------
B-97-14 <bulle Maintenance Process for the 1998 Medicare
t Physician Fee Schedule Database.
B-97-15 <bulle Screening Pap Smear and Pelvic Examinations--
t The Balanced Budget Act of 1997.
B-97-16 <bulle Changes to Correct Coding Edits, Version 4.1.
t
B-97-17 <bulle Private Contracts Between Beneficiaries and
t Physicians/Practitioners.
B-98-1 <bulle Evaluating the Medical Necessity for
t Laboratory Panel Current Procedural
Terminology Codes.
B-98-2 <bulle Payment for the Services of a Certified
t Registered Nurse Anesthetist and a
Anesthesiologist in a Single Anesthesia
Procedure.
B-98-3 <bulle Resolution of Problems in the Initial
t National Provider Identifier Enumeration
Effort from the Unique Physician
Identification Number Registry.
B-98-4 <bulle Instructions to Implement the New Medicare
t Summary Notice.
B-98-5 <bulle Provider Material to be Published in Carrier
t Bulletins.
B-98-6 <bulle Durable Medical Equipment Regional Carrier
t Instructions for Denying Claims and
Recovering Overpayments for Prescription
Drugs Billed and/or Paid to Suppliers Not
Licensed to Dispense Prescriptions Drugs.
B-98-7 <bulle Ongoing Maintenance Process for the 1998
t Durable Medical Equipment, Prosthetics,
Orthotics, and Supplies Fee Schedule.
B-98-8 <bulle Changes to the 1998 Medicare Physician Fee
t Schedule Database.
B-98-9 <bulle Millennium Changes for Forms HCFA-1491,
t 1490S, and 1490U.
B-98-10 <bulle Corrections to Correct Coding Edits, Version
t 4.0.
B-98-11 <bulle Provider Material to be Published in Carrier
t Bulletin.
------------------------------------------------------------------------
Program Memorandum
Intermediaries/Carriers
(HCFA Pub. 60AB)
(Superintendent of Documents No. HE 22.8/6-5)
------------------------------------------------------------------------
AB-97-25 <bulle Implementation of the New Payment Limit for
t Drugs and Biologicals.
AB-97-26 <bulle Coverage and Interim Billing Instructions of
t Oral Anti-Nausea Drugs as Full Therapeutic
Replacements for Intravenous Dosage Forms as
Part of a Cancer Chemotherapeutic Regimen.

[[Page 49602]]

AB-97-27 <bulle Implementing Instructions--Positron Emission
t Tomography Scans for Characterizing Solitary
Pulmonary Nodules or Staging Lung Cancer
Performed on or After January 1, 1998.
AB-98-1 <bulle Balanced Budget Act Requirement to Furnish
t Diagnostic Information.
AB-98-2 <bulle Suspension of National Coverage Policy on
t Electrostimulation for Wound Healing--
(Clarification of Program Memorandum B-97-
11).
AB-98-3 <bulle Temporary National HCFA Common Procedures
t Coding System Codes.
AB-98-4 <bulle Implementation of the Office of the
t Inspector's General Fraud Hot Line Number on
Medicare Beneficiary Notices.
AB-98-5 <bulle Gap-Filling Fee Schedule Amounts for Durable
t Medical Equipment, Prosthetics, Orthotics,
and Supplies Using Fee Schedule Amounts for
Comparable Items.
AB-98-6 <bulle Identifying Employer in Other-than-Data Match
t Group Health Plan Medicare Secondary Payer
Recovery Situations.
AB-98-7 <bulle Implementation of 1998 Clinical Diagnostic
t Laboratory Fee Schedule and Mapping for 1998
Laboratory Coding Changes.
AB-98-8 <bulle New Interest Rate Payable on Clean Claims Not
t Paid Timely.
AB-98-9 <bulle Revised Inherent Reasonableness Policy for
t Durable Medical Equipment, Prosthetics,
Orthotics, and Supplies.
AB-98-10 <bulle Modification of Medicare Coverage of
t Erythropoietin.
------------------------------------------------------------------------
Program Memorandum
Regional Office General
(HCFA Pub. 51)
(Superintendent of Documents No. HE 22.28/5:90-1)
------------------------------------------------------------------------
98-1 <bulle Surety Bond Regulation.
t
98-2 <bulle Home Health Agency Surety Bond Requirements.
t
------------------------------------------------------------------------
Program Memorandum
Insurance Commissioners/Insurance Issuers
(HCFA Pub. 82)
(Superintendent of Documents No. HE 22.8/6-5)
------------------------------------------------------------------------
98-01 <bulle Agent Commissions and Application Processing
t Delays.
------------------------------------------------------------------------
State Operations Manual
Provider Certification
(HCFA Pub. 7)
(Superintendent of Documents No. HE 22.8/12)
------------------------------------------------------------------------
286 <bulle Survey Procedures and Interpretive Guidelines
t for End-Stage Renal Disease Facilities.
1 <bulle The State Operations Manual Has Been Combined
t With the Material From the Regional Office
Manual, and Will Serve as a Basic Guide to
Policies and Procedures for Certification
Purposes.
------------------------------------------------------------------------
Medicare Hospital Manual
(HCFA Pub. 10)
(Superintendent of Documents No. HE 22.8/2)
------------------------------------------------------------------------
726 <bulle Reporting Outpatient Surgery and Other
t Services.
Use of Modifiers in Reporting Hospital
Outpatient Services.
727 <bulle Billing for Mammography Screening
t
------------------------------------------------------------------------
Home Health Agency Manual
(HCFA Pub. 11)
(Superintendent of Documents No. HE 22.8/5)
------------------------------------------------------------------------
286 <bulle Home Health Certification and Plan of Care.
t
Treatment Codes for Home Health Services.
Plan of Care.
Coverage Compliance Review.
Documentation of Skilled Nursing and Home
Health Aide Hours.
Treatment Codes for Professional Services
Required.
Acceptable V Codes.
------------------------------------------------------------------------
Skilled Nursing Facility
(HCFA Pub. 12)
(Superintendent of Documents No. HE 22.8/3)
------------------------------------------------------------------------
352 <bulle Billing for Mammography Screening.
t
------------------------------------------------------------------------
Rural Health Clinic and
Federally Qualified Health Centers Manual
(HCFA Pub. 27)
(Superintendent of Documents No. HE 22.8/19:985)
------------------------------------------------------------------------
29 <bulle Billing for Mammography Screening by Rural
t Health Clinics and Federally Qualified
Health Centers.
------------------------------------------------------------------------

[[Page 49603]]

Coverage Issues Manual
(HCFA Pub. 6)
(Superintendent of Documents No. HE 22.8/14)
------------------------------------------------------------------------
103 <bulle Screening Pap Smears and Pelvic Examinations
t for Early Detection of Cervical or Vaginal
Cancer.
------------------------------------------------------------------------
Provider Reimbursement Manual
Part I
(HCFA Pub. 15-I)
(Superintendent of Documents No. HE 22.8/4)
------------------------------------------------------------------------
401 <bulle Regional Medicare Swing-Bed Skilled Nursing
t Facility Rates.
402 <bulle Acquisitions.
t
Betterments and Improvements.
------------------------------------------------------------------------
Provider Reimbursement Manual
Part II--Provider Cost Reporting Forms and Instructions
(HCFA Pub. 15-II-AH)
(Superintendent of Documents No. HE 22.8/4)
------------------------------------------------------------------------
5 <bulle Independent Renal Dialysis Facility
t Statistical Data.
------------------------------------------------------------------------
State Medicaid Manual
Part III--Eligibility
(HCFA Pub. 45-3)
(Superintendent of Documents No. HE 22.8/10)
------------------------------------------------------------------------
69 <bulle Medicaid Payment for Recipients Under Group
t Health Plans.
------------------------------------------------------------------------
Medicare/Medicaid
Sanction--Reinstatement Report
(HCFA Pub. 69)
------------------------------------------------------------------------
98-1 <bulle Report of Physicians/Practitioners, Providers
t and/or Other Health Care Suppliers Excluded/
Reinstated--December 1997.
97-2 <bulle Report of Physicians/Practitioners, Providers
t and/or Other Health Care Suppliers Excluded/
Reinstated--January 1998.
97-3 <bulle Report of Physicians/Practitioners, Providers
t and/or Other Health Care Suppliers Excluded/
Reinstated--February 1998.
------------------------------------------------------------------------

Addendum IV.--Regulation Documents Published in the Federal Register
--------------------------------------------------------------------------------------------------------------------------------------------------------
End of
Publication date FR Vol. 63 CFR part(s) File code* Regulation title comment Effective
page period date
--------------------------------------------------------------------------------------------------------------------------------------------------------
01/02/98........... 89-105 ...................................... HCFA-1904-NC Medicare Program; 03/03/98 10/01/97
Schedule of Limits on
Home Health Agency Costs
Per Visit for Cost
Reporting Periods
Beginning on or After
October 1, 1997.
01/05/98........... 292-355 413, 440, 441, 489.................... HCFA-1152-FC Medicare and Medicaid 03/06/98 01/01/98
Programs; Surety Bond
and Capitalization
Requirements for Home
Health Agencies.
01/07/98........... 687-690 405................................... HCFA-1908-IFC Medicare Program; 03/09/98 03/09/98
Application of Inherent
Reasonableness to All
Medicare Part B Services
(Other than Physician
Services).
01/09/98........... 1659-1728 411, 424, 435, 455.................... HCFA-1809-P Medicare and Medicaid 03/10/98 01/09/98
Programs; Physicians'
Referrals to Health Care
Entities With Which They
Have Financial
Relationships.
01/09/98........... 1646-1658 411................................... HCFA-1902-IFC Medicare Program; 03/10/98 01/09/98
Physicians' Referrals;
Issuance of Advisory
Opinions.
01/09/98........... 1379-1383 413................................... HCFA-1004-FC Medicare Program; Limit 03/10/98 01/09/98
on the Valuation of a
Depreciable Asset
Recognized as an
Allowance for
Depreciation and
Interest on Capital
Indebtedness After a
Change of Ownership.

[[Page 49604]]

01/20/98........... 2920-2926 ...................................... HCFA-1014-NC Medicare Program; Request 02/19/98 01/20/98
for Public Comments on
Implementation of the
Medicare+Choice Program,
and Notice of Timeframes
for Submission of
Applications for
Contracts.
1/20/98............ 2926-2939 424................................... HCFA-1864-P Medicare Program; 03/23/98 01/20/98
Additional Supplier
Standards.
01/26/98........... 3752-3756 ...................................... HCFA-2005-NC Medicare Program; State 03/27/98 01/01/98
Allotments for Payment
of Medicare Part B
Premiums for Qualifying
Individuals: Federal
Fiscal Year 1998.
01/30/98........... 5106-5139 413................................... HCFA-1808-F Medicare and Medicaid ........... 04/01/98
Programs; Salary
Equivalency Guidelines
for Physical Therapy,
Respiratory Therapy,
Speech Language
Pathology, and
Occupational Therapy
Services.
01/30/98........... 4595-4597 400, 405, 410, 411, 414............... HCFA-1884-CN Medicare Program; ........... 10/31/97
Revisions to Payment
Policies and Adjustments
to the Relative Value
Units Under the
Physician Fee Schedule,
Other Part B Payment
Policies, and
Establishment of the
Clinical Psychologist
Fee Schedule for
Calendar Year 1998;
Correction.
02/04/98........... 5809-5811 ...................................... HCFA-2011-N New and Pending ........... 02/04/98
Demonstration Project
Proposals Submitted
Pursuant to Section
1115(a) of the Social
Security Act: July,
August, September,
October, and November
1997.
02/11/98........... 6864-6869 412, 413.............................. HCFA-1731-F Medicare Program; Payment ........... 03/13/98
for Preadmission
Services.
02/13/98........... 7359-7360 ...................................... HCFA-1037-N Medicare Program; Meeting ........... 02/13/98
of the Negotiated
Rulemaking Committee on
the Provider-Sponsored
Organization Solvency
Standards.
02/17/98........... 7743 416, 482, 485, 489.................... HCFA-3745-N Medicare and Medicaid 03/03/98 02/17/98
Programs; Hospital 04/20/98
Conditions of
Participation; Provider
Agreements and Supplier
Approval; Extension of
Comment Period.
02/19/98........... 8462-8465 ...................................... HCFA-1897-N Medicare Program; Update ........... 10/01/97
of Ambulatory Surgical
Center Payment Rates
Effective for Services
on or After October 1,
1997.
03/04/98........... 10732-10733 ...................................... HCFA-1038-N Medicare and Medicaid ........... 03/04/98
Programs; Surety Bond
Requirements for Home
Health Agencies.
03/04/98........... 10730-10731 441, 489.............................. HCFA-1152-F Medicare and Medicaid ........... 03/04/98
Programs; Surety Bond
Requirements for Home
Health Agencies.
03/04/98........... 10641-10642 ...................................... HCFA-1036-N Medicare Program; March ........... 03/04/98
16-17, 1998, Meeting of
the Practicing
Physicians Advisory
Council.
03/05/98........... 10921-10927 ...................................... HCFA-1103-GN Medicare Program; HCFA 05/04/98 03/04/98
Market Research for
Providers and Other
Partners.
03/06/98........... 11147-11159 400, 409, 410, 411, 412, 413, 424, BPD-878-CN Medicare Program; Changes ........... 10/01/97
440, 485, 488, 489, 498. to the Hospital
Inpatient Prospective
Payment Systems and
Fiscal Year 1998 Rates;
Corrections.
03/10/98........... 11687-11688 ...................................... HCFA-1013-NC Medicare and Medicaid 05/11/98 03/10/98
Programs; Announcement
of Additional
Application From
Hospital Requesting
Waiver for Organ
Procurement Service Area.

[[Page 49605]]

03/10/98........... 11649 411, 424, 435, 455.................... HCFA-1809-N Medicare and Medicaid 05/11/98 03/10/98
Programs; Physicians'
Referrals to Health Care
Entities With Which They
Have Financial
Relationships; Extension
of Comment Period.
03/10/98........... 11686-11687 ...................................... HCFA-2021-N New and Pending ........... 03/10/98
Demonstration Project
Proposals Submitted
Pursuant to Section
1115(a) of the Social
Security Act: December
1997 and January 1998.
03/18/98........... 13260-13262 ...................................... HCFA-3000-N Medicare Programs; 04/17/98 03/10/98
Solicitation of
Proposals for a
Demonstration Project
for the Use of
Informatics,
Telemedicine, and
Education in the
Treatment of Diabetes
Mellitus in the Rural
and Inner-City Medicare
Populations.
03/20/98........... 13590-13608 400, 421.............................. HCFA-7020-P Medicare Program; 05/19/98 03/20/98
Medicare Integrity
Program, Intermediary
and Carrier Functions,
and Conflict of Interest
Requirements.
03/25/98........... 14506-14526 401, 403, 405, 410, 411, 413, 447, HCFA-1719-P Medicare Program; 05/26/98 03/25/98
466, 473, 493. ``Without Fault'' and
Waiver of Recovery from
an Individual as it
Applies to Medicare
Overpayment Liability.
03/31/98........... 15315 413................................... HCFA-1808-CN Medicare and Medicaid ........... 04/10/98
Programs; Salary
Equivalency Guidelines
for Physical Therapy,
Respiratory Therapy,
Speech Language
Pathology, and
Occupational Therapy
Services; Revised
Effective Date and
Technical Correction.
03/31/98........... 15718-15738 413................................... HCFA-1905-FC Medicare Program; 06/01/98 10/01/98
Schedule of Per-
Beneficiary Limitations
on Home Health Agency
Costs for Cost Reporting
Periods Beginning on or
After October 1, 1997.
--------------------------------------------------------------------------------------------------------------------------------------------------------

Categorization of Food and Drug Administration-Approved
Investigational Device Exemptions

Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360c), devices
fall into one of three classes. Also, under the new categorization
process to assist HCFA, the Food and Drug Administration assigns each
device with a Food and Drug Administration-approved investigational
device exemption to one of two categories. To obtain more information
about the classes or categories, please refer to the Federal Register
notice published on April 21, 1997 (62 FR 19328).
The following information presents the device number, category (in
this case, A), and criterion code.

G970106 A1
G970124 A1
G970252 A2
G970281 A2
G970311 A2
G980018 A2
G980020 A1
G980025 A2
G980040 A2

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

G970219 B1
G970230 B4
G970250 B1
G970264 B1
G970285 B2
G970286 B4
G970294 B4
G970302 B4
G970307 B2
G970308 B1
G970310 B2
G970316 B2
G970317 B2
G970321 B4
G970322 B2
G980001 B2
G980002 B4
G980003 B4
G980006 B3
G980007 B2
G980009 B3
G980010 B2
G980014 B4
G980015 B2
G980016 B4
G980019 B1
G980021 B1
G980023 B2
G980027 B3
G980028 B1
G980029 B4
G980030 B1
G980031 B3
G980034 B2
G980036 B4
G980037 B4
G980038 B4
G980039 B2
G980041 B1

[FR Doc. 98-24804 Filed 9-15-98; 8:45 am]
BILLING CODE 4120-01-P

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A98-24804. Public record. Not legal advice.
