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

Federal RegisterJan 10, 2000

Ask Donna

What actually matters in this document.

Text

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

[HCFA-9005-N]

Medicare and Medicaid Programs; Quarterly Listing of Program

Issuances--Second Quarter, 1999

AGENCY: Health Care Financing Administration (HCFA), HHS.

[[Page 1401]]

ACTION: Notice.

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SUMMARY: This notice lists HCFA manual instructions, substantive and

interpretive regulations, and other Federal Register notices that were

published during April, May, and June 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, (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 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 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

[[Page 1402]]

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/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 (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. 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 1-Fiscal Administration (HCFA Pub.

13-1) transmittal entitled ``General,'' use the Superintendent of

Documents No. HE 22.8/6-3 and the HCFA transmittal number 129.

(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: December 21, 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)

December 7, 1999 (64 FR 68357)

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).

[[Page 1403]]

Addendum III.--Medicare and Medicaid Manual Instructions

[April 1999 through June 1999]

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Trans. No. Manual/Subject/Publication No.

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Intermediary Manual

Part 1--Fiscal Administration

(HCFA Pub. 13-1)

(Superintendent of Documents No. HE 22.8/6-3)

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

129 <bulle General.

t

Instructions for Completing the HCFA-750A/B,

Contractor Financial Reports.

Due Date.

Certification.

Instructions for Completing the HCFA-751A/B,

Status of Accounts Receivable.

Line Item Instructions.

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Intermediary Manual

Part 2--Audits-Reimbursements Program Administration

(HCFA Pub. 13-2)

(Superintendent of Documents No. HE 22.8/6-2)

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

412 <bulle List of Medical Review Codes, Categories, and

t Conversion Factors.

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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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1773 <bulle Screening Pap Smears and Screening Pelvic

t Examinations.

1774 <bulle Prostate Cancer Screening Tests and

t Procedures.

1775 <bulle Transmittal 1775 was omitted from the

t sequence and will never be released.

1776 <bulle HCFA Common Procedure Coding System for

t Hospital Outpatient Radiology Services and

Other Diagnostic Procedures.

1777 <bulle Payment for Blood Clotting Factor

t Administered to Hemophilia Inpatients.

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Carriers Manual

Part 1--Fiscal Administration

(HCFA Pub. 14-1)

(Superintendent of Documents No. HE 22.8/7-2)

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

123 <bulle General.

t

Instructions for Completing the HCFA-750B,

Contractor Financial Reports.

Due Date.

Certification.

Instructions for Completing the HCFA-751A/B,

Status of Accounts Receivable.

Line Item Instructions.

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Carriers Manual

Part 3--Claims Process

(HCFA Pub. 14-3)

(Superintendent of Documents No. HE 22.8/7)

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

1631 <bulle Area Carrier-Supplier's Services.

t

1632 <bulle Correct Coding Initiative.

t

1633 <bulle Positron Emission Tomography Scans.

t

...... Conditions of Coverage of Positron Emission

Tomography Scans for Recurrence of

Colorectal Cancer, Staging and

Characterization of Lymphoma, and Recurrence

of Melanoma.

Billing Requirements for Positron Emission

Tomography Scans.

...... HCFA Common Procedure Coding System and

Modifiers for Positron Emission Tomography

Scans.

Claims Processing Instructions for Positron

Emission Tomography Scan Claims.

1634 <bulle Pancreas Transplants.

t

Billing for Pancreas Transplants.

1635 <bulle Transmittal number 1635 was omitted from the

t sequence and will never be released.

1636 <bulle Chiropractors.

t

1637 <bulle Prostate Cancer Screening Tests and

t Procedures.

1638 <bulle Colorectal Cancer Screening.

t

1639 <bulle Private Contracts Between Beneficiaries and

t Physician/Practitioners.

General Rules of Private Contracts.

Effective Date of the Opt Out Provision.

Definition of Physician/Practitioners.

When a Physician or Practitioner Opts Out of

Medicare.

Definition of a Private Contract.

Physician or Practitioner Who Has Never

Enrolled in Medicare.

The Relationship Between This Provision and

Medicare Participation Agreements.

Participating Physicians and Practitioners.

Physicians or Practitioners Who Choose to Opt

Out of Medicare.

[[Page 1404]]

Maintaining Information on Opt Out

Physicians.

Informing Managed Care Plans Who the Opt Out

Physicians or Practitioners Are.

Informing the National Supplier Clearinghouse

Who the Opt Out Physicians or Practitioners

Are.

Organizations that Furnish Physician or

Practitioner Services.

Private Contracting Rules When Medicare is

the Secondary Payer.

System Identification.

Emergency and Urgent Care Situations.

Denial of Payment to Employers of Opt Out

Physicians and Practitioners.

Denial of Payment to Beneficiaries and

Others.

Payment of Medically Necessary Services

Ordered or Prescribed By an Opt Out

Physician or Practitioner.

Mandatory Claims Submission.

Claims Denial Notices to Opt Out Physicians

and Practitioners.

Claims Denial Notices to Beneficiaries.

Effect of Beneficiary Agreements Not to Use

Medicare Coverage.

When Payment May Be Made to a Beneficiary for

Service of an Opt Out Physician or

Practitioner.

Requirements of a Private Contract.

Requirements of the Opt Out Affidavit.

Failure to Properly Opt Out.

Failure to Maintain Opt Out.

Actions to be Taken in Cases of Failure to

Maintain Opt Out.

Non-Participating Physicians or Practitioners

Who Opt Out of Medicare.

Excluded Physicians and Practitioners.

Relationship to Non-Covered Services.

The Difference Between Advance Beneficiary

Notices.

Registration and Identification of Physicians

or Practitioners Who Opt Out.

Definition of Emergency and Urgent Care

Situations.

Renewal of Opt Out.

Early Termination of Opt Out.

Appeals.

Application to Medicare+Choice Contracts.

Reporting.

1640 <bulle Bone Mass Measurements.

t

1641 <bulle Medicare Participating Physician or Supplier

t Agreement.

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Carriers Manual

Part 4--Professional Relations

(HCFA Pub. 14-4)

(Superintendent of Documents No. HE 22.8/7)

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

21 <bulle Appeals.

t

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Program Memorandum

Intermediaries (HCFA Pub. 60A)

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

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A-99-13 <bulle Reopenings for Sole Community Hospital and

t Medicare Dependent Hospital Cost Reports Due

to the Change to the Cost Report

Instructions in Calculating the Hospital-

Specific Amount on Form HCFA-2552-96 and

Form HCFA-2552-92.

A-99-14 <bulle Positron Emission Tomography Scans.

t

A-99-15 <bulle Cryosurgery of the Prostate Gland.

t

A-99-16 <bulle Claims Processing Instructions for Pancreas

t Transplantation.

A-99-17 <bulle Claims Processing Instructions for Cost

t Outlier Bills With Benefits Exhausted.

A-99-18 <bulle Clarification of Provider Cost Report Filing

t Requirements.

A-99-19 <bulle Removal of Edits Requiring Providers to

t Submit Home Health Claims in Sequence.

A-99-20 <bulle Payment Safeguard Review of Skilled Nursing

t Facility Prospective Payment Bills.

A-99-21 <bulle Claims Processing Instructions for Hospice

t Claims Received Out of Sequence.

A-99-22 <bulle Intermediary Review of Hospital Admission

t Questionnaires.

A-99-23 <bulle Managed Care Electronic Data Interchange

t Enrollment Form.

A-99-24 <bulle Policy Clarifications: Provider-Based

t Designation.

A-99-25 <bulle Extended Repayment Schedules for Home Health

t Agencies Affected by the Interim Payment

System.

A-99-26 <bulle Extension of Due Date for Filing Provider

t Cost Reports.

A-99-27 <bulle Home Health Agency Surety Bond Requirements.

t

A-99-28 <bulle Surety Bonds From Home Health Agencies.

t

A-99-29 <bulle Provider Education Information for Home

t Health Agencies--Regional Home Health

Intermediaries Only.

A-99-30 <bulle Provider Education Information for Home

t Health Agencies--Regional Home Health

Intermediaries Only.

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Program Memorandum

Carriers

(HCFA Pub. 60B)

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

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

B-99-13 <bulle Changes to Correct Coding Edits, Version 5.2,

t Effective July 1, 1999.

[[Page 1405]]

B-99-14 <bulle Reviewing Reassignment Agreements of Five or

t More.

B-99-15 <bulle Returns From Year 2000 Mailing.

t

B-99-16 <bulle Discontinuing the Use of Modifiers for

t Processing of Claims for Nurse

Practitioners, Physician Assistants, and

Clinical Nurse Specialists.

B-99-17 <bulle Establishment of Temporary National Modifiers

t to Allow Monitored Anesthesia Care for

Complex, Complicated, or Markedly Invasive

Surgical Procedures and for At Risk

Patients.

B-99-18 <bulle Adjustment in Payment Amounts for New

t Technology Intraocular Lenses Furnished by

Medicare Approved Ambulatory Surgical

Centers.

B-99-19 <bulle Extraction of HCFA Form-484 Certificate of

t Medical Necessity Data.

B-99-20 <bulle Durable Medical Equipment Regional Carriers

t Processing Claims When a Chiropractor is the

Supplier.

B-99-21 <bulle Establishment of Four Temporary National

t ``K'' Codes as Part of Planned Changes to

the Durable Medical Equipment Regional

Carriers Medical Review Policy on

Respiratory Assist Devices.

B-99-22 <bulle Correction of the Published National Standard

t Format Mapping for Remittance Advice.

B-99-23 <bulle Issues Involving Certificates of Medical

t Necessity and Cover Letters for Certificates

of Medical Necessity.

B-99-24 <bulle Changes to the 1999 Medicare Physician Fee

t Schedule Database.

B-99-25 <bulle Billing for Mammography Screening: Delay in

t Carrier Implementation and Coding

Clarification--Implementation of the GH

Modifier.

B-99-26 <bulle Claims Processing Instructions for

t Cryosurgery of the Prostate Gland.

B-99-27 <bulle Consent Settlement for Medical Review Audits.

t

B-99-28 <bulle Correction to Change Request 888 to Provide

t Changes to the 1999 Medicare Physician Fee

Schedule Database.

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Program Memorandum

Intermediaries/Carriers

(HCFA Pub. 60A/B)

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

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

AB-99-12 <bulle Coverage of Testing for Hepatitis C in

t Patients Exposed to Infected Blood.

AB-99-13 <bulle Notification to Medicare Providers and

t Suppliers of Beneficiary Right to an

Itemized Statement.

AB-99-14 <bulle New Waived Tests.

t

AB-99-15 <bulle Medicare Coverage of Abortion Services.

t

AB-99-16 <bulle Changes to the FY 1999 Hospital Inpatient

t Operating Prospective Payment System Wage

Index Geographic and Standardized Amounts,

and Capital Prospective Payment System

Adjustment Factors and Federal Rates.

AB-99-17 <bulle Extension of the Limitation on Payment for

t Services to Individuals Entitled to Benefits

on the Basis of End Stage Renal Disease Who

Are Covered by Group Health Plans.

AB-99-18 <bulle Promoting Influenza and Pneumococcal

t Vaccinations.

AB-99-19 <bulle Expanded Implementation of the Office of the

t Inspector General's Fraud Hotline Number on

Medicare Beneficiary Notices, Effective July

1, 1999.

AB-99-20 <bulle Limited Medicare Coverage and Billing

t Instructions for Enhanced External

Counterpulsation.

AB-99-21 <bulle Claims Processing Instructions for Hyperbaric

t Oxygen Therapy.

AB-99-22 <bulle Transmyocardial Revascularization for

t Treatment of Severe Angina.

AB-99-23 <bulle Reimbursement for Ambulance Services to Non-

t hospital-Based Dialysis Facilities.

AB-99-24 <bulle Y2K--Data Match/MPARTS Mailout Record Layout.

t

AB-99-25 <bulle Beneficiary Right to Itemized Statement.

t

AB-99-26 <bulle Procedures for Write-Off and Adjustment/

t Reclassification of Medicare Contractor NON-

Medicare Secondary Payer Accounts

Receivable.

AB-99-27 <bulle Implementation of Calendar Year 2000 Fee

t Schedules and Pricing Updates.

AB-99-28 <bulle HCFA-1522, Monthly Contractor Financial

t Report, Reconciliation.

AB-99-29 <bulle Notice of New Interest Rate for Medicare

t Overpayments and Underpayments.

AB-99-30 <bulle Implementation of Sec. 4105 of the Balanced

t Budget Act Regarding Coverage of Diabetes

Outpatient Self-Management Training

Services.

AB-99-31 <bulle Assisted Suicide Funding Restriction Act of

t 1997 (P.L. 105-12).

AB-99-32 <bulle Claims Processing Instructions for Hyperbaric

t Oxygen Therapy.

AB-99-33 <bulle Tracking and Reporting Procedures for

t Unsolicited/Voluntary Refund Checks from

Providers/Suppliers-Interim Instructions.

AB-99-34 <bulle Intermediary and Carrier Billing and Claims

t Processing Instructions for Magnetic

Resonance Angiography.

AB-99-35 <bulle Current Status of Medicare Program Memoranda

t Issued Before Calendar Year 1999.

AB-99-36 <bulle Reserved for Y2K Contingency Planning

t Instructions.

AB-99-37 <bulle Reserved for Y2K Contingency Planning

t Instructions.

AB-99-38 <bulle Reserved for Y2K Contingency Planning

t Instructions.

AB-99-39 <bulle Reserved for Y2K Contingency Planning

t Instructions.

AB-99-40 <bulle Reserved for Y2K Contingency Planning

t Instructions.

AB-99-41 <bulle Reserved for Y2K Contingency Planning

t Instructions.

AB-99-42 <bulle Reserved for Y2K Contingency Planning

t Instructions.

AB-99-43 <bulle Reserved for Y2K Contingency Planning

t Instructions.

AB-99-44 <bulle Reserved for Y2K Contingency Planning

t Instructions.

AB-99-45 <bulle Reserved for Y2K Contingency Planning

t Instructions.

AB-99-46 <bulle Coverage of Diabetes Outpatient Self-

t Management Training Services, Effective:

July 1, 1998.

AB-99-47 <bulle New Waived Tests--Effective Date of Receipt.

t

AB-99-48 <bulle Medicare Secondary Payer Denial Indicator and

t the Source Code Changes.

AB-99-49 <bulle Medicare Travel Allowance Fees for Collection

t of Specimens.

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[[Page 1406]]

Program Memorandum

Medicaid State Agencies

(HCFA Pub. 17)

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

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

99-2 <bulle Current Status of Medicaid Program Memoranda

t and Action Transmittals Issued Before

Calendar Year 1999.

99-3 <bulle Title XIX of the Social Security Act,

t Elimination of Waste, Fraud and Abuse.

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

Program Memorandum

Regional Offices--Standards and Certification

(HCFA Pub. 54)

(Superintendent of Documents No. HE 22.28/5:90-1)

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

99-1 <bulle Civil Monetary Penalty Collection Procedures.

t

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

State Operations Manual

Provider Certification

(HCFA Pub. 7)

(Superintendent of Documents No. HE 22.8/12)

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

8 <bulle Resident Assessment in Long Term Care

t Facilities.

9 <bulle Medicare Rural Hospital Flexibility Program.

t

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

Peer Review Organization Manual

(HCFA Pub. 19)

(Superintendent of Documents No. HE 22.8/8-15)

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

71 <bulle Critical Access Hospital Acute Care Inpatient

t Stays Review.

72 <bulle Introduction.

t

Staffing Functions.

Mandatory System Use.

Operations.

Communication.

Confidentiality of System.

Applicable Documentation.

Process for Moving.

Standard Data Processing System Engineering

Review Board Process-Approved Software and

Hardware.

Hardware Maintenance Process.

Standard Data Processing System Data

Management Plan.

73 <bulle Request for Information Model Cover Letter.

t

Request for Information Model Form.

Final Response to Inquirer Model Notice

(Concern Involved Practitioner).

Final Response to Inquirer Model Notice

(Concern Involved Provider (Facility)).

Beneficiary Complaint Timetable for

Retrospective Review (Fee-for-Service and

Managed Care).

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

Beneficiary Complaint Timetable for

Concurrent Review (Fee-for-Service and

Managed Care).

Hospital Manual

(HCFA Pub. 10)

(Superintendent of Documents No. HE 22.8/2)

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

742 <bulle Screening Pap Smears and Screening Pelvic

t Examinations.

743 <bulle Payment for Blood Clotting Factor

t Administered to Hemophilia Inpatients.

744 <bulle Coding for Adequacy of Hemodialysis.

t

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

End Stage Renal Disease

Network Organizations Manual

(HCFA Pub. 81)

(Superintendent of Documents No. HE 22.9/4)

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

9 <bulle Background.

t

Definition.

Requirements.

Disagreements.

HCFA Office of Clinical Standards and Quality

Requirements.

Statutory and Regulatory Requirements.

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.

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

[[Page 1407]]

Coverage Issues Manual

(HCFA Pub. 6)

(Superintendent of Documents No. HE 22.8/14)

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

109 <bulle Cardiac Output Monitoring by Electrical

t Bioimpedance.

Prostate Cancer Screening Tests.

110 <bulle Transmyocardial Revascularization for

t Treatment of Severe Angina.

Cryosurgery of the Prostate.

111 <bulle Enhanced External Counterpulsation.

t

112 <bulle Hyberbaric Oxygen Therapy.

t

113 <bulle Positron Emission Tomography Scans.

t

114 <bulle Vagus Nerve Stimulation for the Treatment of

t Seizures.

115 <bulle Pancreas Transplants.

t

Implantation of Automatic Defibrillators.

116 <bulle Home Use of Oxygen.

t

117 <bulle Magnetic Resonance Angiography.

t

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

Provider Reimbursement Manual--Part 2

Provider Cost Reporting Forms and Instructions

Chapter 36--Form HCFA-2552-96

(HCFA Pub. 15-2-36)

(Superintendent of Documents No. HE 22.8/4)

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

5 <bulle Hospital and Hospital Health Care Complex

t Cost Reporting Form.

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

Provider Reimbursement Manual--Part 2

Provider Cost Reporting Forms and Instructions

Chapter 38--Form HCFA-1984-99

(HCFA Pub. 15-2-38)

(Superintendent of Documents No. HE 22.8/4)

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

1 <bulle Hospice Cost Reporting Form.

t

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

Medicare/Medicaid

Sanction--Reinstatement Report

(HCFA Pub. 69)

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

99-3 <bulle Report of Physicians/Practitioners, Providers

t and/or Other Health Care Suppliers Excluded/

Reinstated-February 1999.

99-4 <bulle Report of Physicians/Practitioners, Providers

t and/or Other Health Care Suppliers Excluded/

Reinstated-March 1999.

99-5 <bulle Report of Physicians/Practitioners, Providers

t and/or Other Health Care Suppliers Excluded/

Reinstated-April 1999.

99-6 <bulle Report of Physicians/Practitioners, Providers

t and/or Other Health Care Suppliers Excluded/

Reinstated-May 1999.

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

Addendum IV.--Regulation Documents Published in the Federal Register

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

FR Vol. 64 End of comment

Publication Date Page CFR \1\ Part(s) File Code \2\ Regulation title period Effective date

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

04/08/99 17184-17185 .................... HCFA-1071-N......... Medicare Program; April .................... ....................

23, 1999, Open Town Hall

Meeting to Discuss the

Skilled Nursing Facility

Prospective Payment

System (SNF/PPS) and

Quality of Care in

Nursing Facilities.

04/26/99 21196-21301 21 CFR Ch. 1; 42 CFR .................... Unified Agenda of Federal .................... ....................

Chs. I-V; and 45 Regulatory and

CFR Subtitle A, Deregulatory Actions.

Chs. II, III, and

XIII.

04/27/99 22619-22626 .................... HCFA-3432-GN........ Medicare Program; .................... 06/28/99

Procedures for Making

National Coverage

Decisions.

05/03/99 23653-23654 .................... HCFA-1101-N2........ Medicare Program; .................... ....................

Meetings of the

Competitive Pricing

Demonstration Area

Advisory Committee,

Maricopa County, AZ.

[[Page 1408]]

05/07/99 24550-24551 42 CFR Part 405..... HCFA-1002-N......... Medicare Program; .................... ....................

Meetings of the

Negotiated Rulemaking

Committee on Ambulance

Fee Schedule.

05/07/99 24716-24864 412, 413, 483, and HCFA-1053-N......... Medicare Program; Changes 07/06/99............

485. to the Hospital

Inpatient Prospective

Payment System and

Fiscal Year 2000 Rates.

05/10/99 24956-24957 498................. HCFA-3139-F......... Medicare Program and .................... 09/17/97

Medicaid Programs;

Effective Dates of

Provider Agreements and

Supplier Approvals;

Correction.

05/11/99 25351-25359 .................... HCFA-9000-N......... Medicare and Medicaid

Programs; Quarterly

Listing of Program

Issuances-Third Quarter,

1998.

05/12/99 25456-25460 405, 410, 413, 414, HCFA-1006-CN........ Medicare Program; .................... 01/01/99

415, 424, and 485. Revisions to Payment

Policies and Adjustments

to the Relative Value

Units Under the

Physician Fee Schedule

for Calendar Year 1999;

Correction.

05/14/99 26426-26427 .................... HCFA-1072-N......... Medicare Program; June

14, 1999, Meeting of the

Practicing Physicians

Advisory Council.

05/28/99 29186-29188 45 CFR Subtitle A... .................... Coverage for Breast 06/28/99............

Reconstruction and

Related Services After a

Mastectomy.

06/04/99 30042-30043 .................... HCFA-1075-N......... Medicare Program; June

25, 1999, Public Meeting

To Discuss the Payment

Classification for

Respiratory Assist

Devices.

06/09/99 31006-31007 .................... HCFA-1080-N......... Medicare Program; Meeting

of the Competitive

Pricing Demonstration

Area Advisory Committee,

Maricopa County, AZ.

06/10/99 31281-31282 .................... HCFA-1081-N......... Medicare Program; June

24, 1999, Meeting of the

Competitive Pricing

Advisory Committee and

the Area Advisory

Committee for the Kansas

City Metropolitan Area.

06/15/99 31995-32021 412, 413, 483, and HCFA-1053-CN........ Medicare Program; Changes

485. to the Hospital

Inpatient Prospective

Payment Systems and

Fiscal Year 2000 Rates;

Correction.

06/16/99 32198-32206 416................. HCFA-3831-F......... Medicare Program; .................... 07/16/99

Adjustment in Payment

Amounts for New

Technology Intraocular

Lenses Furnished by

Ambulatory Surgical

Centers.

06/18/99 32881-32886 .................... HCFA-2039-FN........ Medicare Program; .................... 06/18/99-06/18/03

Recognition of the Joint

Commission for

Accreditation of

Healthcare Organizations

(JCAHO) for Hospices.

06/18/99 32983-32991 .................... HCFA-3020-N......... Medicare and Medicaid .................... 07/19/99

Programs; Mandatory Use,

Collection, Encoding,

and Transmission of

Outcome and As sessment

Information Set (OASIS)

for Home Health Agencies.

[[Page 1409]]

06/18/99 32992-32998 .................... .................... Privacy Act of 1974; .................... 06/18/99 or 07/28/99

Report of New System.

06/22/99 33314-33315 .................... HCFA-1081-2N........ Medicare Program;

Cancellation of the June

24, 1999, Meeting of the

Competitive Pricing

Advisory Committee and

the Area Advisory

Committee for the Kansas

City Metropolitan Area.

06/30/99 35257-35513 409, 410, 411, 412, HCFA-1005-CN........ Medicare Program;

413, 419, 489, 498, Prospective Payment for

and 1003. Hospital Outpatient

Services; Correction;

Proposed Rule.

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

\1\ 42 CFR except where noted.

\2\ 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.

G940094 A1

G940156 A1

G970104 A1

G970204 A1

G980179 A2

G980283 A1

G990056 A1

G990062 A2

G990071 A1

The following information presents the device number, category (in

this case, B), and criterion code.

G980237 B2

G980258 B2

G980317 B1

G980329 B2

G990002 B2

G990013 B2

G990018 B2

G990027 B3

G990059 B3

G990063 B4

G990065 B4

G990072 B1

G990073 B

G990079 B2

G990081 B3

G990082 B2

G990086 B4

G990087 B4

G990088 B2

G990090 B4

G990091 B4

G990093 B2

G990095 B4

G990096 B3

G990098 B4

G990099 B2

G990106 B2

G990109 B4

G990115 B3

G990117 B1

G990119 B4

G990136 B3

[FR Doc. 00-505 Filed 1-7-00; 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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