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

Federal RegisterSep 16, 1998

Ask Donna

What actually matters in this document.

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]

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Trans. No. Manual/Subject/Publication No.

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Intermediary Manual

Part 3--Claims Process

(HCFA Pub. 13-3)

(Superintendent of Documents No. HE 22.8/6)

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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.

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Carriers Manual

Part 3--Claims Process

(HCFA Pub. 14-3)

(Superintendent of Documents No. HE 22.8/7)

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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.

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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

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Program Memorandum

Carriers

(HCFA Pub. 60B)

(Superintendent of Documents No. HE 22.8/6-5)

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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.

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Program Memorandum

Intermediaries/Carriers

(HCFA Pub. 60AB)

(Superintendent of Documents No. HE 22.8/6-5)

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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.

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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.

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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.

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[[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.

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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)

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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

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.

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