Medicare and Medicaid Programs; Quarterly Listing of Program IssuancesFirst Quarter, 1999

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.

-----------------------------------------------------------------------

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