00-13347. Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-Third 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 July, August, and September of 1999, relating to the Medicare and Medicaid programs. This notice 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, [phone].

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, [phone].

Questions concerning Food and Drug Administration-approved investigational device exemptions may be addressed to Sharon Hippler, Office of Clinical Standards and Quality, Coverage and Analysis Group, Health Care Financing Administration, C4-11-04, 7500 Security Boulevard, Baltimore, MD 21244-1850, [phone].

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, [phone].

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 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 Food and Drug Administration 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 [phone], Fax number [phone] (for credit card orders); or

National Technical Information Service, Department of Commerce, 5825 Port Royal Road, Springfield, VA 22161, Telephone [phone].

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/​nara/​index.html,, 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 [phone]; 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. 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 (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 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, Part 3-Claims Process, (HCFA Pub. 13-3) transmittal entitled “Outpatient Therapeutic Services,” use the Superintendent of Documents No. HE 22.8/6 and the HCFA transmittal number 1778.

(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: May 22, 2000.

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)

December 7, 1999 (64 FR 68357)

January 10, 2000 (65 FR 1400)

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

[July 1999 through September 1999]

Trans. No.		Manual/Subject/Publication No.
Intermediary Manual
Part 3—Claims Process (HCFA Pub.13-3)
(Superintendent of Documents No. HE 22.8/6)
1778	•	Outpatient Therapeutic Services
		Oral Anti-Nausea Drugs as Full Therapeutic Replacements for Intravenous Dosage Forms as Part of Cancer Chemotherapeutic Regimen
1779	•	Requirements-General
		Election Procedures
		Election, Revocation, and Change of Hospice
		Covered Services
		Special Coverage Requirements
1780	•	Electronic Media Claims
		Requirements for Submission of Electronic Media Claims Data
		File Specifications, Records Specifications, and Data Element Definitions for Electronic Media Claims Bills
		Medicare Intermediary Standard Paper Remittance
		Electronic UB-92 Change Request Procedures
		Medicare Standard Electronic Remittance
		Support of Non-Millennium Electronic Formats
		National Standard Electronic Remittance Advice
1781	•	Prospective Payment System PRICER Program
		Provider—Specific Payment Data
		Provider Specific Data Record Layout and Description
		Intermediary Responsibilities
Carriers Manual
Part 3—Claims Process (HCFA Pub. 14-3)
(Superintendent of Documents No. HE 22.8/7)
1642	•	Self-Administered Drugs and Biologicals
		Payment for Oral Anti-emetic Drugs When Used as Full Replacement for Intravenous Anti-emetic Drugs as Part of a Cancer Chemotherapeutic Regimen
1643	•	Claims Involving Beneficiaries Who Have Elected Hospice Coverage
1644	•	Reimbursement for Physician's Visits to Nursing Home Patients
		Physicians' Services Paid Under Fee Schedule
		Entities/Suppliers Whose Physicians' Services Are Paid for Under Fee Schedule
		Payment at Medically Directed Payment Rate
		Specific Hematology, Cytopathology, and Blood Banking Services
		Payment Conditions for Radiology Services
		Payment for Physicians Services Furnished to Dialysis Inpatients
		Payment for Initial Hospital Care Services
		Consultations
		Reporting of Visit When Patient is Seen in Emergency Department and Emergency Department Physician Requests Another Physician to See the Patient in Emergency Department or Office/Outpatient Setting
		Home Services
1645	•	Reassignment
		Payment to Employer of Physician
		Payment to Facility in Which Services Are Performed
		Payment to Health Care Delivery System
		Payment to Physician for Purchased Diagnostic Tests
		Payment to Supplier of Diagnostic Tests for Purchased Interpretations
		Payment Under Locum Tenens Arrangements
1646	•	Requirements for Electronic Data Interchange
		Telecommunications Systems and Methods
		Electronic Data Interchange System
		Electronic Data Interchange Testing and Verification
		Technical Requirements
		Technical Assistance for Electronic Data Interchange Trading Partners
		Prohibition of Exclusive Use of Proprietary Software
		Hardware
		Medicare Standard Personal Computer-Print B Software
		Support of Non-Millennium Electronic Formats
		National Standard Format Maintenance Procedures
1647	•	Correct Coding Initiative
1648	•	Colorectal Cancer Screening
		Bone Mass Measurements.
1649	•	Pancreas Transplants
Program Memorandum
Intermediaries (HCFA Pub. 60A)
(Superintendent of Documents No. HE 22.8/6-5)
A-99-31	•	Clarifications to Program Memorandum A-99-6, Dated February 1999, 15 Minute Increment Reporting for Home Health Services
A-99-32	•	Medical Review Activities Following the Removal of Home Health Sequential Billing Edits—Regional Home Health Intermediaries Only
A-99-33	•	Change in Hospice Payment Rates, Update to the Hospice Cap, Revised Hospice Wage Index and Hospice PRICER.
A-99-34	•	Implementation of Federal Register Notice to be Published on or About July 30, 1999 of Revised Per-Beneficiary and Per Visit Limitations on Home Health Agency Costs for Cost Reporting Periods Beginning on or After October 1, 1999 and Portions of Cost Reporting Periods Beginning Before October 1, 2000
A-99-35	•	Change to Reporting of Outpatient Rehabilitation Services and All Comprehensive Outpatient Rehabilitation Agency Services Using HCFA Common Procedure Coding System
A-99-36	•	Year 2000 Procedures: Develop Modified System for Beneficiary Requests for Immediate Peer Review Organization Review of Hospital Issued Notices of Noncoverage
A-99-37	•	Home Health Advance Beneficiary Notices Must Be Given to Beneficiaries by Home Health Agencies and Demand Bills Must Be Submitted Promptly
A-99-38	•	Home Health Advance Beneficiary Notices Must Be Given to Beneficiaries by Home Health Agencies and Demand Bills Must Be Submitted Promptly
A-99-39	•	Payment Safeguard Review Instructions for Psychiatric Partial Hospitalization Claims
A-99-40	•	Deactivation of Inactive Community Mental Health Center Medicare Numbers
A-99-41	•	Clarification of Modifier Usage in Reporting Outpatient Hospital Services
A-99-42	•	The Supplemental Security Income Medicare Beneficiary Data for Fiscal Year 1998 for Prospective Payment System Hospitals
Program Memorandum
Carriers (HCFA Pub. 60B)
(Superintendent of Documents No. HE 22.8/6-5)
B-99-29	•	Returns From Year 2000 Mailing
B-99-30	•	Changes to the 1999 Medicare Physician Fee Schedule Database
B-99-31	•	Change to Health Insurance Claim Form HCFA-1500 Instructions for Processing Physician Claims in Global Payment Systems
B-99-32	•	Durable Medical Equipment Regional Carrier Instructions to Implement Balanced Budget Act of 1997 Provisions § 4105 to Provide Expanded Coverage of Blood Glucose Monitors and Test Strips for all Diabetics. Implement July 1, 1998
B-99-33	•	Change to Health Insurance Claim Form HCFA-1500 Instructions for Processing Physician Claims in Global Payment Systems
B-99-34	•	Site Visits and Enrollment of Independent Diagnostic Testing Facilities
Program Memorandum
Intermediaries/Carriers (HCFA Pub. 60A/B)
(Superintendent of Documents No. HE 22.8/6-5)
AB-99-50	•	Further Delay of Change Request 796 (Coverage Issues Manual § 35-10 Hyperbaric Oxygen Therapy)
AB-99-51	•	Limited Medicare Coverage and Billing Instructions for Enhanced External Counterpulsation
AB-99-52	•	Suspension of National Coverage Policy on Electrostimulation for Wound Healing
AB-99-53	•	Final Rule Revising and Updating Medicare Policies Concerning Ambulance Services
AB-99-54	•	Clarification of Program Memorandum AB-99-27—Implementation of Calendar Year 2000 Fee Schedules and Pricing Updates
AB-99-55	•	Transmittal Number AB-99-55 has been rescinded and will not be released
AB-99-56	•	Biomedical Equipment Year 2000 Compliance
AB-99-57	•	October 1, 1999 Payment and Coding Updates
AB-99-58	•	Modified Procedures for Sharing HCFA Data with the Department of Justice
AB-99-59	•	Medicare Coverage of Epoetin Alfa (Procrit) for Preoperative Use
AB-99-60	•	Notice of New Interest Rate for Medicare Overpayments and Underpayments
AB-99-61	•	Mandatory Submission of Social Security Account Numbers and Employer Identification Numbers
AB-99-62	•	Quarterly Update for 1999 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Fee Schedule
AB-99-63	•	Implementation of the New Payment Limit for Drugs and Biologicals.
AB-99-64	•	Education of Medicare Providers on the Adoption of Standard Electronic Health Care Transaction Formats in the United States
AB-99-65	•	Implementing Coordination of Benefits Contractor Numbers
AB-99-66	•	Provider Education Article: Submitting, Processing, and Paying Year 2000 Medicare Claims
AB-99-67	•	Update of Rates and Wage Index for Ambulatory Surgical Center Payments Effective October 1, 1999
AB-99-68	•	Provider Education Article: National Provider Education and Training Program
AB-99-69	•	Instruction Implementation Reporting
AB-99-70	•	Provider Education Article: Submitting, Processing, and Paying Year 2000 Medicare Claims
AB-99-71	•	Year 2000 HCFA Common Procedure Coding System Update
Program Memorandum
State Survey Agencies (HCFA Pub. 65)
(Superintendent of Documents No. HE 22.8/6-5)
99-1	•	Policy Clarification: Home Health Agency Parent, Branch and Subunit Criteria
State Operations Manual Provider Certification
(HCFA Pub. 7)
(Superintendent of Documents No. HE 22.8/12)
10	•	Roster/Sample Matrix
		Roster/Sample Matrix Provider Instructions
		Roster/Sample Matrix Surveyor Instructions
		Facility Characteristics
		Facility Quality Indicator Profile
		Resident Level Summary
		Quality Indicator Matrix
		Survey Procedures for Long Term Care Facilities
		Guidance to Surveyors
Peer Review Organization Manual
(HCFA Pub 19)
(Superintendent of Documents No HE 22 8/8-15)
74	•	Purpose of Peer Review Organization Review
		Peer Review Organization Responsibilities
		Health Care Financing Administration's Role
		Health Care Quality Improvement Program
		Payment Error Prevention Program
75	•	Objectives of the Internal Quality Control Program
		Internal Quality Control Program Requirements
		Internal Quality Control Process
		Analysis and Reporting Requirements
		Peer Review Organization Review Documentation
		Reporting Requirements
		Peer Review Organization Intermediary Data Exchange Reports
76	•	Authority
		Scope of Review
		Complaints That Do Not Meet Statutory Requirements
		Referrals
		Review Process
		Notice of Disclosure
		Disclosure of Quality Review Information to Complaints
Hospice Manual
(HCFA Pub. 21)
(Superintendent of Documents No. HE 22.8/18)
55	•	Eligibility and Coverage
		Eligibility Requirements
		Use of Election Periods
		Election, Revocation and Change of Hospice
		Covered Services
		Core Services
		Special Coverage Requirements
		Notice of Election
		Hospice Payment Rates
		Local Adjustment of Payment Rates
		Cap on Overall Reimbursement
		Adjustments to Cap Amount
Coverage Issues Manual
(HCFA Pub. 6)
(Superintendent of Documents No. HE 22.8/14)
118	•	Enhanced External Counterpulsation for Severe Angina
119	•	Pancreas Transplants
Provider Reimbursement Manual—Part 1
(HCFA Pub. 15-1)
(Superintendent of Documents No. HE 22.8/4)
409	•	Travel Expense
Provider Reimbursement Manual—Part 2
Provider Cost Reporting Forms and Instructions
Chapter 18—Form HCFA-2088-92
(HCFA Pub. 15-2-18)
(Superintendent of Documents No. HE 22.8/4)
3	•	Outpatient Rehabilitation Provider Cost Reporting Form
Provider Reimbursement Manual—Part 2
Provider Cost Reporting Forms and Instructions
Chapter 32—Form HCFA-1728-94
(HCFA Pub. 15-2-32)
(Superintendent of Documents No. HE 22.8/4)
7	•	Home Health Agency Cost Reporting Form
		Electronic Reporting Specifications
Provider Reimbursement Manual—Part 2
Provider Cost Reporting Forms and Instructions
Chapter 35—Form HCFA-2540-96
(HCFA Pub. 15-2-35)
(Superintendent of Documents No. HE 22.8/4)
5	•	Skilled Nursing Facility Cost Reporting Form
		Skilled Nursing Facility Complex Cost Reporting Form
Medicare/Medicaid
Sanction—Reinstatement Report
(HCFA Pub. 69)
99-7	•	Report of Physicians/Practitioners, Providers and/or Other Health Care Suppliers Excluded/Reinstated—June 1999
99-8	•	Report of Physicians/Practitioners, Providers and/or Other Health Care Suppliers Excluded/Reinstated—July 1999
99-9	•	Report of Physicians/Practitioners, Providers and/or Other Health Care Suppliers Excluded/Reinstated—August 1999

Addendum IV.—Regulation Documents Published in the Federal Register

Publication date	FR Vol. 64 page	CFR* part(s)	File code**	Regulation title	End of comment period	Effective date
07/02/99	36069-36089	482	HCFA-3018-IFC	Medicare and Medicaid Programs; Hospital Conditions of Participation: Patients' Rights	08/31/99	08/02/99
07/06/99	36320-36321	409, 410, 411, 412, 413, 419, 489, 498, and 1003	HCFA-1005-4N	Medicare Program; Prospective Payment System for Hospital Outpatient Services; Extension of Comment Period	07/30/99
07/06/99	36321-36322	416 and 488	HCFA-1885-6N	Medicare Program; 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	07/30/99
07/07/99	36695-36696		HCFA-1082-N	Medicare Program; July 22, 1999, Meeting of the Competitive Pricing Advisory Committee and the Area Advisory Committee for the Kansas City Metropolitan
07/16/99	38395-38396	405	HCFA-1083-N	Medicare Program; Meetings of the Negotiated Rulemaking Committee on Ambulance Fee Schedule
07/22/99	39608-39771	410, 411, 414, and 415	HCFA-1065-P	Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2000	09/20/99
07/23/99	39934-39938	431 and 498	HCFA-2054-IFC	Medicare and Medicaid Program; Appeal of the Loss of Nurse Aide Training Programs	09/21/99	07/23/99
07/27/99	40534-40539	414	HCFA-1010-P	Medicare Program; Replacement of Reasonable Charge Methodology by Fee Schedules	09/27/99
07/30/99	41489-41641	412, 413, 483, and 485	HCFA-1053-F	Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2000 Rates	10/01/99
07/30/99	41684-41701		HCFA-1056-N	Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities—Update		10/01/99
07/30/99	41643-41683	409, 411, 413, and 489	HCFA-1913-F	Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities		09/28/99
08/03/99	42139-42140		HCFA-3021-N	Medicare Program; August 31, 1999 Open Town Hall Meeting To Discuss the End Stage Renal Disease Network Organizations (ESRD Networks) Activities
08/04/99	42393-42402		HCFA-1054-N	Medicare Program; Hospice Wage Index		10/01/99
08/04/99	42403-42406		HCFA-0002-N	Medicare Program; Year 2000 Readiness Letters
08/05/99	42610-42614	413	HCFA-1883-F	Medicare Program; Revision of the Procedures for Requesting Exceptions to Cost Limits for Skilled Nursing Facilities and Elimination of Reclassifications		09/07/99
08/05/99	42766-42789		HCFA-1060-NC	Medicare Program; Schedules of Per-Visit and Per-Beneficiary Limitations on Home Health Agency Costs for Cost Reporting Periods Beginning on or After October 1, 1999 and Portions of Cost Reporting Periods Beginning Before October 1, 2000	10/04/99	10/01/99 and 10/01/00
08/09/99	43198-43200		HCFA-1055-NC	Medicare and Medicaid Programs; Announcement of Additional Applications From Hospitals Requesting Waivers for Organ Procurement Service Areas	10/08/99
08/10/99	43295	498	HCFA-2054-CN	Medicare and Medicaid Program; Appeal of the Loss of Nurse Aide Training Programs; Correction		07/23/99
08/10/99	43338-43339	Chapter IV	HCFA-3250-N3	Medicare Program; Negotiated Rulemaking; Coverage and Administrative Policies for Clinical Diagnostic Laboratory Tests; Announcement of Additional Public Meetings
08/18/99	44841-44856	413	HCFA-1001-IFC	Medicare Program; Graduate Medical Education (GME): Incentive Payments Under Plans for Voluntary Reduction in the Number of Residents	10/18/99	09/17/99
08/20/99	45785-45807	45 CFR 144, 146, 148, and 150	HCFA-2019-IFC	Federal Enforcement in Group and Individual Health Insurance Markets	10/19/99	09/20/99
08/24/99	46205-46206		HCFA-1076-N	Medicare Program; September 16, 1999, Meeting of the Competitive Pricing Advisory Committee
08/27/99	46920		HCFA-1077-N	Medicare Program; September 23, 1999, Meeting of the Competitive Pricing Demonstration Area Advisory Committee, Maricopa County
09/07/99	48661		HCFA-1078-N	Medicare Program; September 27 and 28, 1999, Meeting of the Practicing Physicians Advisory Council
09/09/99	49020-49021		HCFA-1087-N	Medicare Program; Open Public Meeting To Discuss the Conduct of a Second Competitive Bidding Demonstration
09/10/99	49199-49201		HCFA-2057-PN	Medicare and Medicaid Programs; Reapplication of the American Osteopathic Association (AOA) for Continued Approval of Deeming Authority for Hospitals	10/12/99
09/10/99	49197-49198		HCFA-2058-PN	Medicare and Medicaid Programs; Application of the Joint Commission for Accreditation of Healthcare Organizations (JCAHO) for Continued Approval of Deeming Authority for Home Health Agencies	10/12/99
09/10/99	49121-49128	435, 436, and 440	HCFA-2082-N	Medicaid Program; Optional Coverage of Certain Tuberculosis-Related Services to TB-Infected Individuals	11/09/99
09/16/99	50288		HCFA-1039-CN2	Medicare Program; Hospice Wage Index; Correction		10/01/99
09/17/99	50482-50483	405	HCFA-1086-N	Medicare Program; Meetings of the Negotiated Rulemaking Committee on the Ambulance Fee Schedule
09/17/99	50523-50524		HCFA-1090-N	Medicare Program; October 6, 1999 and November 15, 1999, Meetings of the Competitive Pricing Demonstration Area Advisory Committee, Kansas City, MO Metropolitan Area
09/27/99	51908-51910	413	HCFA-1876-F	Medicare Program; Revision to Accrual Basis of Accounting Policy		11/26/99
09/28/99	52377		HCFA-1054-N	Medicare Program; Hospice Wage Index
09/30/99	52665-52670	405	HCFA-4121-FC	Medicare Program; Telephone Requests for Review of Part B Initial Claim Determinations	11/29/99	02/01/00
*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.

G 990077—A2

G 990162—A1

G 990169—A2

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

G 980325—B3

G 990123—B1

G 990124—B4

G 990125—B2

G 990127—B4

G 990131—B3

G 990132—B2

G 990134—B4

G 990137—B1

G 990138—B5

G 990139—B3

G 990142—B4

G 990143—B3

G 990144—B2

G 990146—B2

G 990148—B4

G 990150—B3

G 990151—B2

G 990152—B2

G 990153—B4

G 990155—B2

G 990156—B2

G 990158—B3

G 990164—B4

G 990171—B1

G 990172—B2

G 990174—B4

G 990175—B2

G 990176—B4

G 990177—B4

G 990178—B2

G 990179—B

G 990181—B4

G 990183—B4

G 990185—B3

G 990189—B3

G 990192—B1

G 990194—B4

G 990197—B4

G 990199—B4

G 990207—B2

G 990209—B4