Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Notices 33119

Board of Governors of the Federal Reserve

System, June 20, 1996.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 96–16264 Filed 6–25–96; 8:45 am]

BILLING CODE 6210–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

The National Center for Infectious

Diseases (NCID), of the Centers for

Disease Control and Prevention (CDC)

Announces the Following Meeting

Name: Pre-Application Workshop for

Program Announcement Number 620:

Prevention of the Complications of

Hemophilia through Hemophilia Treatment

Centers (HTCs).

Time and Date: 11 a.m.–5 p.m., July 2,

1996.

Place: CDC, Building 16, Room 1107A

1600 Clifton Road, Atlanta, Georgia 30333.

Status: Open to the public, limited only by

the space available. The meeting room

accommodates approximately 35 people.

Purpose: The purpose of this meeting is to

provide an opportunity for programmatic and

business management technical assistance

regarding the cooperative agreement,

‘‘Prevention of the Complications of

Hemophilia through HTCs.’’ An important

component of the workshop will be a

question and answer session. A summary of

the answers will be made available to all

eligible applicants upon request.

CONTACT PERSON FOR ADDITIONAL

INFORMATION: Sarah Wiley, Project

Officer, Hematologic Diseases Branch,

Division of AIDS, STD, and TB

Laboratory Research, NCID, CDC, 1600

Clifton Road, M/S E64, Atlanta, Georgia

30333, telephone 404/639–4026.

Dated: June 20, 1996.

John C. Burckhardt,

Acting Director, Management Analysis and

Services Office, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 96–16288 Filed 6–25–96; 8:45 am]

BILLING CODE 4163–18–M

Agency for Toxic Substances and

Disease Registry; Citizens Advisory

Committee on Public Health Service

Activities and Research at Department

of Energy Sites: Hanford Health Effects

Subcommittee Meeting: Date Change

Federal Register Citation of Previous

Announcement: 61 FR 17304—dated

April 19, 1996.

SUMMARY: Notice is given that one of the

meeting dates for the Citizens Advisory

Committee on Public Health Service

Activities and Research at Department

of Energy Sites: Hanford Health Effects

Subcommittee, of the Agency for Toxic

Substances and Disease Registry

(ATSDR), has changed. The meeting

place, time, status, purpose, and matters

to be discussed, announced in the

original notice remain unchanged.

ORIGINAL DATES: September 19–20, 1996.

NEW DATES: September 12–13, 1996.

CONTACT PERSON FOR MORE INFORMATION:

Linda A. Carnes, Health Council

Advisor, ATSDR, M/S E–28, 1600

Clifton Road, NE, Atlanta, Georgia

30333, telephone 404/639–0730, FAX

404/639–0759.

Dated: June 20, 1996.

John C. Burckhardt,

Acting Director, Management Analysis and

Services Office, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 96–16287 Filed 6–25–96; 8:45 am]

BILLING CODE 4163–70–M

Health Care Financing Administration

[BPO–137–N]

Medicare and Medicaid Programs;

Quarterly Listing of Program

Issuances and Coverage Decisions—

Fourth Quarter 1995

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, and statements

of policy that were published during

October, November, and December of

1995 that relate to the Medicare and

Medicaid programs. It also identifies

certain devices with investigational

device exemption numbers approved by

the Food and Drug Administration that

may be potentially covered under

Medicare.

Section 1871(c) of the Social Security

Act requires that we publish a list of

Medicare issuances in the Federal

Register at least every 3 months.

Although we are not mandated to do so

by statute, for the sake of completeness

of the listing, we are including all

Medicaid issuances and Medicare and

Medicaid substantive and interpretive

regulations (proposed and final)

published during this time frame. We

are also providing the content of

revisions to the Medicare Coverage

Issues Manual published during the

period October 1 through December 31,

1995. On August 21, 1989, we published

the content of the Manual (54 FR 34555)

and indicated that we will publish

quarterly any updates. Adding to this

listing the complete text of the changes

to the Medicare Coverage Issues Manual

fulfills this requirement in a manner

that facilitates identification of coverage

and other changes in our manuals.

FOR FURTHER INFORMATION CONTACT:

Margaret Cotton, (410) 786–5255 (For

Medicare instruction information).

Pat Prete, (410) 786–3246 (For Medicaid

instruction information).

Sharon Hippler, (410) 786–4633 (For

Food and Drug Administrationapproved investigational device

exemption information).

Cathy Johnson, (410) 786–5241 (For all

other information).

SUPPLEMENTARY INFORMATION:

I. Program Issuances

The Health Care Financing

Administration (HCFA) is responsible

for administering the Medicare and

Medicaid programs, which pay for

health care and related services for 38

million Medicare beneficiaries and 36

million Medicaid recipients.

Administration of these programs

involves (1) providing information to

Medicare beneficiaries and Medicaid

recipients, health care providers, and

the public, and (2) effective

communications with regional offices,

State governments, State Medicaid

Agencies, State Survey Agencies,

various providers of health care, fiscal

intermediaries and carriers that process

claims and pay bills, and others. To

implement the various statutes on

which the programs are based, we issue

regulations under the authority granted

the Secretary under sections 1102, 1871,

and 1902 and related provisions of the

Social Security Act (the Act) and also

issue various manuals, memoranda, and

statements necessary to administer the

programs efficiently.

Section 1871(c)(1) of the Act requires

that we publish in the Federal Register

at least every 3 months a list of all

Medicare manual instructions,

interpretive rules, statements of policy,

and guidelines of general applicability

not issued as regulations. We published

our first notice June 9, 1988 (53 FR

21730). Although we are not mandated

to do so by statute, for the sake of

completeness of the listing of

operational and policy statements, we

are continuing our practice of including

Medicare substantive and interpretive

regulations (proposed and final)

published during the 3-month time

frame. Since the publication of our

quarterly listing on June 12, 1992 (57 FR

24797), we decided to add Medicaid

issuances to our quarterly listings.

Accordingly, we list in this notice

Medicaid issuances and Medicaid
33120 Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Notices

substantive and interpretive regulations

published during October through

December 1995.

II. Medicare Coverage Issues

We receive numerous inquiries from

the general public about whether

specific items or services are covered

under Medicare. Providers, carriers, and

intermediaries have copies of the

Medicare Coverage Issues Manual,

which identifies those medical items,

services, technologies, or treatment

procedures that can be paid for under

Medicare. On August 21, 1989, we

published a notice in the Federal

Register (54 FR 34555) that contained

all the Medicare coverage decisions

issued in that manual.

In that notice, we indicated that

revisions to the Coverage Issues Manual

will be published at least quarterly in

the Federal Register. We also sometimes

issue proposed or final national

coverage decision changes in separate

Federal Register notices. Readers

should find this an easy way to identify

both issuance changes to all our

manuals and the text of changes to the

Coverage Issues Manual.

Revisions to the Coverage Issues

Manual are not published on a regular

basis but on an as-needed basis. We

publish revisions as a result of

technological changes, medical practice

changes, responses to inquiries we

receive seeking clarifications, or the

resolution of coverage issues under

Medicare. If no Coverage Issues Manual

revisions were published during a

particular quarter, our listing will reflect

that fact.

Not all revisions to the Coverage

Issues Manual contain major changes.

As with any instruction, sometimes

minor clarifications or revisions are

made within the text. This notice

contains, as Addendum IV, reprinted

manual revisions as transmitted to

manual holders. The new text is shown

in italics. We have not reprinted the

table of contents, since the table of

contents serves primarily as a finding

aid for the user of the manual and does

not identify items as covered or not.

III. 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,

coverage decisions, or Food and Drug

Administration-approved

investigational device exemptions

published during the time frame to

determine whether any are of particular

interest. We expect it to be used in

concert with previously published

notices. Most notably, those unfamiliar

with a description of our Medicare

manuals may wish to review Table I of

our first three notices (53 FR 21730, 53

FR 36891, and 53 FR 50577) and the

notice published March 31, 1993 (58 FR

16837), and those desiring information

on the Medicare Coverage Issues

Manual may wish to review the August

21, 1989 publication (54 FR 34555).

To aid the reader, we have organized

and divided this current listing into six

addenda. Addendum I identifies

updates that changed the Coverage

Issues Manual. We published notices in

the Federal Register that included the

text of changes to the Coverage Issues

Manual. These updates, when added to

material from the manual published on

August 21, 1989 constitute a complete

manual as of the end of the quarter

covered by this notice. Parties interested

in obtaining a copy of the manual and

revisions should follow the instructions

in section IV of this notice.

Addendum II identifies previous

Federal Register documents that

contain a description of all previously

published HCFA Medicare and

Medicaid manuals and memoranda.

Addendum III of this notice lists, for

each of our manuals or Program

Memoranda, a HCFA transmittal

number unique to that instruction and

its subject matter. A transmittal may

consist of a single instruction or many.

Often it is necessary to use information

in a transmittal in conjunction with

information currently in the manuals.

Addendum IV sets forth the revisions

to the Medicare Coverage Issues Manual

that were published during the quarter

covered by this notice. For the revisions,

we give a brief synopsis of the revisions

as they appear on the transmittal sheet,

the manual section number, and the title

of the section. We present a complete

copy of the revised material, no matter

how minor the revision, and identify the

revisions by printing in italics the text

that was changed. If the transmittal

includes material unrelated to the

revised section, for example, when the

addition of revised material causes other

sections to be repaginated, we do not

reprint the unrelated material.

Addendum V lists all substantive and

interpretive Medicare and Medicaid

regulations and general notices

published in the Federal Register

during the quarter covered by this

notice. For each item, we list the date

published, the Federal Register citation,

the parts of the Code of Federal

Regulations (CFR) that have changed (if

applicable), the agency file code

number, the title of the regulation, the

ending date of the comment period (if

applicable), and the effective date (if

applicable).

On September 19, 1995, we published

a final rule (60 FR 48417) establishing

in regulations 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. That final rule states

that we will announce in this quarterly

notice all investigational device

exemption categorizations, using the

investigational device exemption

numbers the Food and Drug

Administration assigns. Addendum VI

includes listings of the Food and Drug

Administration-approved

investigational device exemption

numbers that have been approved

during the quarter covered by this

notice. The listings are organized

according to the categories to which the

device numbers are assigned (that is,

Category A or Category B, and identified

by the investigational device exemption

number). Future notices will announce

investigational device exemption

categorizations and the numbers

assigned by the Food and Drug

Administration for the quarter for which

the notices cover.

IV. How to Obtain Listed Material

A. Manuals

An individual or organization

interested in routinely receiving any

manual and revisions to it may purchase

a subscription to that manual. Those

wishing to subscribe should contact

either the Government Printing Office

(GPO) or the National Technical

Information Service (NTIS) at the

following addresses:

Superintendent of Documents,

Government Printing Office, ATTN:

New Order, 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.

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
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Notices 33121

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 (1) the

World Wide Web—the Superintendent

of Documents home page address is

http://www.access.gpo.gov/suldocs/;

(2) local WAIS client software, or (3)

telnet—swais.access.gpo.gov, then login

as guest (no password required). Dial-in

users should use communications

software and modem to call (202) 512–

1661; type swais, then login as guest (no

password required). For general

information about GPO Access, contact

the GPO Access User Support Team by

sending Internet e-mail to

help@eids05.eids gpo.gov; by faxing to

(202) 512–1262; or by calling (202) 512–

1530 between 7 a.m. and 5 p.m. Eastern

time, Monday–Friday, except for

Federal holidays.

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 also

sometimes publish Rulings in the

Federal Register.

D. HCFA’s Compact Disk-Read Only

Memory (CD–ROM)

Our laws, regulations, and manuals

are also available on CD–ROM, which

may be purchased from GPO or NTIS on

a subscription or single copy basis. The

Superintendent of Documents list ID is

HCLRM, and the stock number is 717–

139–00000–3. The following material is

on the CD–ROM disk:

• Titles XI, XVIII, and XIX of the Act.

• HCFA-related regulations.

• HCFA manuals and monthly

revisions.

• HCFA program memoranda.

The titles of the Compilation of the

Social Security Laws are current as of

January 1, 1995. The remaining portions

of CD–ROM are updated on a monthly

basis.

Because of complaints about the

unreadability of the Appendices

(Interpretive Guidelines) in the State

Operations Manual (SOM), as of March

1995, we deleted these appendices from

CD–ROM. We intend to re-visit this

issue in the near future, and with the

aid of newer technology, we may again

be able to include the appendices on

CD–ROM.

Any cost report forms incorporated in

the manuals are included on the CD–

ROM disk as LOTUS files. LOTUS

software is needed to view the reports

once the files have been copied to a

personal computer disk.

V. How to Review Listed Material

Transmittals or Program Memoranda

can be reviewed at a local Federal

Depository Library (FDL). Under the

FDL program, government publications

are sent to approximately 1400

designated libraries throughout the

United States. Interested parties may

examine the documents at any one of

the FDLs. Some may have arrangements

to transfer material to a local library not

designated as an FDL. To locate the

nearest FDL, contact any library.

In addition, individuals may contact

regional depository libraries, which

receive and retain at least one copy of

most Federal government publications,

either in printed or microfilm form, for

use by the general public. These

libraries provide reference services and

interlibrary loans; however, they are not

sales outlets. Individuals may obtain

information about the location of the

nearest regional depository library from

any library. Superintendent of

Documents numbers for each HCFA

publication are shown in Addendum III,

along with the HCFA publication and

transmittal numbers. To help FDLs

locate the instruction, use the

Superintendent of Documents number,

plus the HCFA transmittal number. For

example, to find the Carriers Manual,

Part 3—Claims Process (HCFA-Pub. 14–

3) transmittal entitled ‘‘SelfAdministered Drugs and Biologicals,’’

use the Superintendent of Documents

No. HE 22.8/7 and the HCFA transmittal

number 1528.

VI. General Information

It is possible that an interested party

may have a specific information need

and not be able to determine from the

listed information whether the issuance

or regulation would fulfill that need.

Consequently, we are providing

information contact persons to answer

general questions concerning these

items. Copies are not available through

the contact persons. Copies can be

purchased or reviewed as noted above.

Questions concerning Medicare items

in Addenda III may be addressed to

Margaret Cotton, Bureau of Program

Operations, Issuances Staff, Health Care

Financing Administration, S3–01–27,

7500 Security Blvd., Baltimore, MD

21244–1850, Telephone (410) 786–5255.

Questions concerning Medicaid items

in Addenda III may be addressed to Pat

Prete, Medicaid Bureau, Office of

Medicaid Policy, Health Care Financing

Administration, C4–25–02, 7500

Security Boulevard, Baltimore, MD

21244–1850, Telephone (410) 786–3246.

Questions concerning Food and Drug

Administration- approved

investigational device exemptions may

be addressed to Sharon Hippler, Bureau

of Policy Development, Office of

Chronic Care and Insurance Policy,

Health Care Financing Administration,

C4–11–04, 7500 Security Blvd.,

Baltimore, MD 21244–1850, Telephone

(410) 786–4633.

Questions concerning all other

information may be addressed to Cathy

Johnson, Bureau of Policy Development,

Office of Regulations, Health Care

Financing Administration, C5–09–05,

7500 Security Blvd., Baltimore, MD

21244–1850, Telephone (410) 786–5241.

(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: June 6, 1996.

Carol Walton,

Director, Bureau of Program Operations.

Addendum I

This addendum lists the publication

dates of the most recent quarterly listing

of program issuances and coverage

decision updates to the Coverage Issues

Manual. For a complete listing of the

quarterly updates to the Coverage Issues

Manual published during March 20,

1990 through November 14, 1994,

please refer to the January 3, 1995

update (60 FR 134).

January 3, 1995 (60 FR 132)

April 6, 1995 (60 FR 17538)

July 26, 1995 (60 FR 38344)

November 15, 1995 (60 FR 57435)

April 8, 1996 (61 FR 15491)

Addendum II—Description of Manuals,

Memoranda, and HCFA Rulings

An extensive descriptive listing of

Medicare manuals and memoranda was

published on June 9, 1988, at 53 FR

21730 and supplemented on September

22, 1988, at 53 FR 36891 and December

16, 1988, at 53 FR 50577. Also, a

complete description of the Medicare

Coverage Issues Manual was published

on August 21, 1989, at 54 FR 34555. A

brief description of the various

Medicaid manuals and memoranda that

we maintain was published on October

16, 1992, at 57 FR 47468.
33122 Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Notices

ADDENDUM III.—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS

[October through December 1995]

Trans.

No. Manual/Subject/Publication No.

Intermediary Manual

Part 3—Claims Process (HCFA—Pub. 13–3)

(Superintendent of Documents No. HE 22.8/6–1)

1662 • Rural Health Clinics—General

1663 • Medicare Fraud and Abuse

1664 • Accessibility Criteria

Designated Intermediaries

Designated Carriers

1665 • Review of Form HCFA–1450 for Inpatient and Outpatient Bills

Bill Review for Partial Hospitalization Services Provided In Community Mental Health Centers

Hospital Outpatient Partial Hospitalization Services

1666 • Requirements by Record Type and Field (Data Element) for Outpatient Rehabilitative Services

1667 • Diagnostic Services and Radiological Therapy

Application of Fee Schedule

1668 • HCPCS for Hospital Outpatient Radiology Services and Other Diagnostic Procedures

PPS Pricer Program

Provider-Specific Data Record Layout and Description

1669 • Provider Electronic Billing File and Record Formats

1670 • Mammography Screening

Carriers Manual—Part 3

Claims Process (HCFA—Pub. 14–3)

(Superintendent of Documents No. HE 22.8/7)

1527 • Payment for Outpatient Clinical Diagnostic Laboratory Tests Using Fee Schedules and for Specimen Collection

1528 • Self-Administered Drugs and Biologicals

1529 • Quarterly Supplements to Carrier Performance Report Forms HCFA–1565A, HCFA–1565B, HCFA–1565C, HCFA–1565D, and

HCFA–1565E)—General

Checking Form A Prior to Submittal to HCFA

Completing Health Professional Shortage Area Quarterly Report, Form HCFA–1565E—General

1530 • Payment for Outpatient Clinical Diagnostic Laboratory Tests Using Fee Schedules and For Specimen Collection

Review of Laboratory Results by Physicians

Payment for Outpatient Clinical Diagnostic Laboratory Tests Using Fee Schedules and For Specimen Collection

Laboratory Claims

Documentation for Nonphysician Claims

1531 • Report on Number of Participating Physician and Suppliers

1532 • Medicare Fraud and Abuse

Program Memorandum

Intermediaries (HCFA—Pub. 60A)

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

A–95–

11

• Hospital Waivers for Organ Procurement Service Areas

A–95–

12

• FY 1996 Prospective Payment System and Other Bill Processing Changes

A–95–

13

• Recision of Requirement for Monthly Billing for Part A Home Health, Hospice, and Rural Health Clinic Providers

A–95–

14

• Extension of Due Date for Filing Provider Cost Reports

A–95–

15

• Hospital Outpatient Procedures: 1996 Update to List of Radiology Procedures and Other Diagnostic Services Subject to Payment Limitation and New Instructions on Grossing Up

Program Memorandum

Intermediaries/Carriers (HCFA—Pub. 60AB)

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

AB–95–

11

• Standard Rates for Transmitting Claims Information Between Medicare Contractors and Complementary Insurers for FY 96

Program Memorandum

Medicaid State Agencies (HCFA—Pub. 17)

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

95–7 • Title XIX, Social Security Act, Tuberculosis—Infected Individuals
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Notices 33123

ADDENDUM III.—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS—Continued

[October through December 1995]

Trans.

No. Manual/Subject/Publication No.

Skilled Nursing Facility Manual

(HCFA—Pub. 12)

(Superintendent of Documents No. HE 22.8/3)

340 • Other Services

341 • Skilled Nursing Facility Defined

Transfer Agreements

Medical and Other Health Services Furnished to Patients of Participating SNFs

Diagnostic X-ray and Clinical Laboratory Tests

Providing Services Under Arrangement

Billing for Durable Medical Equipment, Orthotic/Prosthetic Devices and Surgical Dressings

Billing for Laboratory Tests

342 • Billing for Mammography Screening

Coverage Issues Manual

(HCFA—Pub. 6)

(Superintendent of Documents No. HE 22.8/14)

80 • Magnetic Resonance Angiography

81 • Pneumatic Compression Devices (Used for Lymphedema)

82 • Artificial Hearts And Related Devices

83 • Lung Volume Reduction Surgery (Reduction Pneumoplasty, also called Lung Shaving, or Lung Contouring) Unilateral or Bilateral by Open or Thoracoscopic Approach for Treatment of Emphysema and Chronic Obstructive Pulmonary Disease-Not

Covered

Peer Review Organization

(HCFA—Pub. 19)

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

54 • PRO Quality Improvement Activities

Purpose of Data Exchange Reports

Reporting Requirements

PRO/Intermediary Data Exchange Reports

55 • Conducting PDC

56 • 60-Day PRO Review: Opportunity for Discussion

57 • Transfers

Hospital-Requested Higher-Weighted DRG Adjustments

Hospital Manual

(HCFA—Pub. 10)

(Superintendent of Documents No. HE 22.8/2)

685 • Payment for Services Received in Nonparticipating Providers

Designated Intermediaries

Designated Carriers

686 • Billing for Hospital Outpatient Partial Hospitalization Services

Completion of Form HCFA–1450 for Inpatient and/or Outpatient Billing

687 • Billing for Mammography Screening

Provider Reimbursement Manual—Part 1

(HCFA—Pub. 15–1)

(Superintendent of Documents No. HE 22.8/4)

384 • Regional Medicare Swing-Bed SNF Rates

385 • Reasonable Costs

Factors To Be Considered in Determining Reasonable Cost of Purchased Management and Administrative Support Services

Insurance Purchased From a Limited Purpose Insurance Company

Legal Fees and Other Related Costs

386 • Inpatient Routine Nursing Salary Cost Differential

Requirements to Fund Plan

Allowability of Payments

Exception to 1-Year Time Limit

Limitation on Federal Participation for Capital Expenditures

Designated Planning Agencies

Intermediary Responsibility

Record of Capital Expenditures

Appeals

387 • Political and Lobbying Activities

Provider Political Activities

Provider Lobbying Activities
33124 Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Notices

ADDENDUM III.—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS—Continued

[October through December 1995]

Trans.

No. Manual/Subject/Publication No.

Professional, Technical, or Business Related Organizations

Civic Organizations

Organization Dues Related to Lobbying and Political Activities

388 • Reorganization Costs

Provider Reimbursement Manual

Part II—Provider Cost Reporting Forms and Instructions Chapter 11—Form HCFA–339

(HCFA—Pub. 15–IIK)

(Superintendent of Documents No. HE 22.8/4)

4 • Changes to Form HCFA–339

State Medicaid Manual

Part 15—Income and Eligibility Verification System

(HCFA—Pub. 45–15)

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

5 • This transmittal deletes Chapters 1–5

Medicare Outpatient Physical Therapy and Comprehensive Outpatient Rehabilitation

Facility Manual (HCFA—Pub. 9)

(Superintendent of Documents No. HE 22.8/9)

123 • Completion of Form HCFA–1450 for Billing CORF, Outpatient Physical Therapy, Occupational Therapy or Speech Pathology

Services

Billing Instructions for Partial Hospitalization Services Provided in Community Mental Health Centers

Rural Health Clinic and Federally Qualified Health Centers Manual

(HCFA—Pub. 27)

(Superintendent of Documents No. HE 222.8/19:985)

21 • Billing for Mammography Screening by Rural Health Clinics and Federally Qualified Health Centers

State Medicaid Manual

Part 6—Payment for Services (HCFA—Pub. 45–6)

(Superintendent of Documents No. HE 22.8/10)

29 • Drug Ingredient Prices

Medicare/Medicaid

Sanction—Reinstatement Report (HCFA—Pub. 69)

95–11 • Report of Physicians/Practitioners, Providers and/or Other Health Care Suppliers Excluded/Reinstated—August 1995

95–12 • Report of Physicians/Practitioners, Providers and/or Other Health Care Suppliers Excluded/Reinstated—September 1995

95–13 • Report of Physicians/Practitioners, Providers and/or Other Health Care Suppliers Excluded/Reinstated—October 1995

95–14 • Report of Physicians/Practitioners, Providers and/or Other Health Care Suppliers Excluded/Reinstated—November 1995

Addendum IV—Medicare Coverage

Issues Manual

(For the reader’s convenience, new material

and changes to previously published material

are in italics. If any part of a sentence in the

manual instruction has changed, the entire

line is shown in italics. The transmittal

includes material unrelated to revised

sections. In this addendum we do not reprint

the unrelated material.)

Transmittal No. 80; section 50–13.

50–13 Magnetic Resonance Imaging

(Effective for services performed on or

after 11–22–85.)

Magnetic resonance imaging (MRI),

formerly called nuclear magnetic

resonance (NMR), is covered under

Medicare when furnished as described

below for the types of covered

conditions described in this instruction.

A. General

1. Method of Operation.—Magnetic

resonance imaging is a noninvasive

method of graphically representing the

distribution of water and other

hydrogen-rich molecules in the human

body. In contrast to conventional

radiographs or CT scans, in which the

image is produced by X-ray beam

attenuation by an object, MRI is capable

of producing images by several

techniques. In fact, various

combinations of MR image production

methods may be employed to emphasize

particular characteristics of the tissue or

body part being examined. The basic

elements by which MRI produces an

image are the density of hydrogen

nuclei in the object being examined,

their motion, and the relaxation times,

the period of time required for the

nuclei to return to their original states

in the main, static magnetic field after

being subjected to a brief additional

magnetic field. These relaxation times

reflect the physical-chemical properties

of tissue and the molecular environment

of its hydrogen nuclei. Only hydrogen

atoms are present in human tissues in

sufficient concentration for current use

in clinical MRI.

2. General Clinical Utility.—Overall,

MRI is a useful diagnostic imaging

modality that is capable of

demonstrating a wide variety of soft-
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Notices 33125

tissue lesions with contrast resolution

equal or superior to CT scanning in

various parts of the body. Among the

advantages of MRI are the absence of

ionizing radiation and the ability to

achieve high levels of tissue contrast

resolution without injected iodinated

radiological contrast agents. Recent

advances in technology have resulted in

development and FDA approval of new

paramagnetic contrast agents for MRI

which allow even better visualization in

some instances. Multislice imaging and

the ability to image in multiple planes,

especially sagittal and coronal, have

provided a flexibility not easily

available with other modalities. Because

cortical (outer layer) bone and metallic

prostheses do not cause distortion of

MR images, it has been possible to

visualize certain lesions and body

regions with greater certainty than has

been possible with CT. The use of MRI

on certain soft tissue structures for the

purpose of detecting disruptive,

neoplastic, degenerative, or

inflammatory lesions has now become

established in medical practice.

B. Covered Clinical Applications—

Although several uses of MRI are still

considered investigational and some

uses are clearly contraindicated (see

subsection D), MRI is considered

medically efficacious for a number of

uses. Use the following descriptions as

general guidelines or examples of what

may be considered covered rather than

as a restrictive list of specific coverages.

Coverage is limited to MRI units which

have received FDA premarket approval,

and such units must be operated within

the parameters specified by the

approval. As with all items and services,

the services must be reasonable and

necessary for the diagnosis or treatment

of the specific patient involved.

MRI is useful in examining the head,

central nervous system, and spine.

Multiple sclerosis can be diagnosed

with MRI and the contents of the

posterior fossa are visible. The inherent

tissue contrast resolution of MRI makes

it an appropriate standard diagnostic

modality for general neuroradiology.

MRI can assist in the differential

diagnosis of mediastinal and

retroperitoneal masses, including

abnormalities of the large vessels such

as aneurysms and dissection. When a

clinical need exists to visualize the

parenchyma of solid organs to detect

anatomic disruption or neoplasia, this

can be accomplished in the liver,

urogenital system, adrenals, and pelvic

organs without the use of radiological

contrast materials. When MRI is

considered reasonable and necessary,

the use of paramagnetic contrast

materials may be covered as part of the

study. MRI may also be used to detect

and stage pelvic and retroperitoneal

neoplasms and to evaluate disorders of

cancellous bone and soft tissues. It may

also be used in the detection of

pericardial thickening.

Primary and secondary bone

neoplasm and aseptic necrosis can be

detected at an early stage and monitored

with MRI. Patients with metallic

prostheses, especially of the hip, can be

imaged in order to detect the early

stages of infection of the bone to which

the prothesis is attached.

Effective for services provided on or

after 03/22/94, MRI may also be covered

to diagnose disc disease without regard

to whether radiological imaging has

been tried first to diagnose the problem.

C. Gating Devices and Surface Coils

(Effective for Services On or After 3/04/

91)—Gating devices which eliminate

distorted images caused by cardiac and

respiratory movement cycles are now

considered state of the art techniques

and may be covered. Surface and other

specialty coils may also be covered, as

they are used routinely for high

resolution imaging where small limited

regions of the body are studied. They

produce high signal-to-noise ratios

resulting in images of enhanced

anatomic detail.

D. Contraindications and Noncovered

Uses—1. Contraindications.—MRI is not

covered when the following patientspecific contraindications are present. It

is not covered for patients with cardiac

pacemakers or with metallic clips on

vascular aneurysms. MRI during a

viable pregnancy is also contraindicated

at this time. The danger inherent in

bringing ferromagnetic materials within

range of MRI units generally constrains

the use of MRI on acutely ill patients

requiring life support systems and

monitoring devices which employ

ferromagnetic materials. In addition, the

long imaging time and the enclosed

position of the patient may result in

claustrophobia, making patients who

have a history of claustrophobia

unsuitable candidates for MRI

procedures.

2. Noncovered Uses.—Several uses of

MRI have been identified as

investigational and are not covered.

These include measurement of blood

flow and spectroscopy. In addition, MRI

is not suitable for the imaging of cortical

bone and calcifications and for

procedures involving spatial resolution

of bone or calcifications.

Transmittal No. 80; section 50–14.

New Implementing Instructions—

Effective Date: Services furnished on or

after October 1, 1995.

Section 50–14, Magnetic Resonance

Angiography, is added to provide

limited coverage of magnetic resonance

angiography (M.A.) procedures.

Previously, coverage of the MRA was a

matter of carrier discretion. MRA

procedures are covered for the

evaluation of carotid vessels found in

the head and neck and when performed

on beneficiaries: (1) with vascular

conditions of the head and neck for

which surgery is anticipated; and (2) for

whom conventional catheter

angiography is inappropriate because of

contraindications to contrast media. All

other applications of MRA performed on

or after October 1, 1995 are to be

considered noncovered.

50–14 Magnetic Resonance

Angiography

Magnetic resonance angiography

(MRA) is an application of magnetic

resonance imaging that provides

visualization of blood flow, as well as

images of normal and diseased blood

vessels. MRA techniques typically are

noninvasive because they do not require

the use of contrast media. (While

contrast media may sometimes be used

to enhance the images obtained in MRA,

the use of these agents is not necessary.)

As a result, MRA is an attractive

imaging alternative for patients who

cannot tolerate contrast media.

Although MRA may be performed on

several different anatomical regions,

presently available scientific data and

studies reveal that the most clinically

useful application of MRA is in the

evaluation of blood flow and vessels in

the head and neck. In addition, studies

have proven that MRA is most effective

when evaluating large vessels, such as

the carotids, which are located in the

area of the head and neck. Since the

clinical value of MRA for anatomical

regions other than the head and neck is

not yet proven, Medicare will cover

MRA only on a limited basis. Therefore,

effective for services furnished on or

after October 1, 1995, all of the

following requirements must be fulfilled

before Medicare coverage is available for

MRA:

• The MRA is for the evaluation of

the carotid vessels in the head and neck;

• The MRA is performed on patients

with vascular conditions of the head

and neck, such as carotid stenosis, for

which surgery is anticipated and may be

found to be appropriate based on the

MRA test results; and

• The MRA is performed when

conventional catheter angiography is

inappropriate because the patient has

contraindications to contrast media.

Readily acceptable scientific data are

lacking for other applications of MRA.

Therefore, effective for services
33126 Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Notices

furnished on or after October 1, 1995,

other applications are not covered.

This limited coverage policy will be

assessed and reviewed as new

information becomes available, in order

to determine whether the limited

coverage should be continued,

expanded, or retracted.

Transmittal No. 81; section 60–20.

Changed Procedures—Effective Date:

June 1, 1995.

This revision to the Coverage Issues

Manual was originally issued as

Transmittal #77. It is now being reissued

to indicate an effective date of June 1,

1995. This policy may be applied to

claims with a date of service on or after

June 1, 1995. Do not reopen any claims.

However, if claims come to your

attention, process them applying the

revised policy.

Section 60–16, Pneumatic

Compression Devices (Used for

Lymphedema), is revised to clarify (1)

that the nonsegmented and segmented

pump without manual control of

pressure in each chamber is considered

the least costly alternative that meets

the clinical needs of the individual for

this type of durable medical equipment

(HCPCS codes E0650 and E0651), unless

there is documentation that warrants

payment of the more costly manual

control pump (HCPCS code E0652); (2)

the documentation needed for

determination of the type of pump to be

used for the treatment of lymphedema;

and (3) which pneumatic compression

pump is appropriate for chronic venous

insufficiency.

60–20 Transcutaneous Electrical

Nerve Stimulators (Tens)

TENS is a type of electrical nerve

stimulator that is employed to treat

chronic intractable pain. This

stimulator is attached to the surface of

the patient’s skin over the peripheral

nerve to be stimulated. It may be

applied in a variety of settings (in the

patient’s home, a physician’s office, or

in an outpatient clinic). Payment for

TENS may be made under the durable

medical equipment benefit. (See § 45–25

for an explanation of coverage of

medically necessary supplies for the

effective use of TENS and § 45–19 for an

explanation of coverage of TENS for

acute post-operative pain.)

Transmittal No. 82; sections 65–14

and 65–15.

Changed Procedures—Effective Date:

01–22–96.

Section 65–15, Artificial Hearts And

Related Devices, amends this section by

removing the words ‘‘not covered’’ from

the title. Also, it revises the statement of

general noncoverage of these devices to

allow exceptions for use of the BVS

5000 for temporary life support and the

addition of coverage of the use of the

HeartMate IP LVAS for use as a bridge

to cardiac transplantation.

65–14 Cochlear Implantation

A cochlear implant device is an

electronic instrument, part of which is

implanted surgically to stimulate

auditory nerve fibers, and part of which

is worn or carried by the individual to

capture and amplify sound. Cochlear

implant devices are available in single

channel and multi-channel models. The

purpose of implanting the device is to

provide an awareness and identification

of sounds and to facilitate

communication for persons who are

profoundly hearing impaired.

Medicare coverage is provided only

for those patients who meet all of the

following selection guidelines.

A. Adults.—

• Diagnosis of total sensorineural

deafness that cannot be mitigated by use

of a hearing aid in patients whose

auditory cranial nerves are stimulable;

• Cognitive ability to use auditory

clues and a willingness to undergo an

extended program of rehabilitation;

• Post-lingual deafness;

• Adulthood (at least 18 years of

age);

• Freedom from middle ear

infection, an accessible cochlear lumen

that is structurally suited to

implantation, and freedom from lesions

in the auditory nerve and acoustic areas

of the central nervous system; and

• No contraindications to surgery.

B. Children (Effective for services

performed on and after 12/31/92)—.The

FDA has approved marketing of a multichannel cochlear implant device for use

in prelingually and postlingually

deafened children 2 through 17 years of

age. (FDA-approved labeling limits use

of the device in adults to those who are

postlingually deafened.) Medicare

coverage is provided for such a device

for children who meet the following

patient selection guidelines. There are

two exceptions to this general

prohibition for two specific devices

which have been approved by the Food

and Drug Administration. These are

described below.

• No contraindications to the

implant, including those described in

the product’s FDA-approved package

insert;

• Diagnosis of bilateral profound

sensorineural deafness with little or no

benefit from a hearing (or vibrotactile)

aid, as demonstrated by the inability to

improve on age appropriate closed-set

word identification tasks;

• Freedom from middle ear

infection, an accessible cochlear lumen

that is structurally suited to

implantation, and freedom from lesions

in the auditory nerve and acoustic areas

of the central nervous system; and

• The device must be used in

accordance with the FDA-approved

labeling.

65–15 Artificial Hearts and Related

Devices

There are several devices either in use

or under development which replace all

or part of the human heart or assist the

heart in performing its pumping

function. Artificial hearts are considered

investigational and not covered under

Medicare either when used as a

permanent replacement for a human

heart or when used as temporary lifesupport systems (i.e., until a human

heart becomes available for transplant).

The FDA-approved ventricular assist

device (known as the B.S. 5000) is

covered when it is used in accordance

with its FDA-approved labeled uses for

postcardiotomy ventricular dysfunction.

The device is intended for short term

use and is not covered when used as a

bridge to cardiac transplantation. The

FDA-approved HeartMate Implantable

Pneumatic Left Ventricular Assist

Systems (HeartMate IP LVAS) is

covered:

A. When it is used in accordance with

its FDA-approved labeled uses as a

temporary mechanical circulatory

support for approved transplant

candidates in nonreversible left

ventricular failure as a bridge to cardiac

transplantation; and

B. Only if all of the following

conditions are met:

1. The patient is an approved heart

transplant candidate, i.e., approved and

listed as a candidate by a Medicareapproved heart transplant center;

2. The implantation of the system is

done in a Medicare-approved heart

transplant center, either on a patient

listed by that center, or, if the patient is

listed by another Medicare-approved

center, with the written permission of

the center listing the patient;

3. The patient is on inotropes;

4. The patient is on an intra-aortic

balloon pump (if possible); and

5. The patient has left atrial pressure

or pulmonary capillary wedge pressure

> 20 mm Hg with either:

a. Systolic blood pressure < 80 mm

Hg; or

b. Cardiac index of < 2.0 1/min/m2.

Coverage of this device is limited to its

FDA-approved use as a bridge to

transplantation. Consequently, centers

implanting such devices should make

every reasonable effort to transplant

patients on such devices as soon as

practicable. Ideally, they should
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Notices 33127

determine patient-specific timetables for

transplantation and should not maintain

such patients on this device if suitable

hearts become available for

transplantation.

Other ventricular assist devices used

as temporary life-support systems are

still considered investigational and are

not covered under the Medicare

program.

Transmittal No. 83; section 35–93.

MANUALIZATION—EFFECTIVE

DATE: NOT APPLICABLE.

Section 35–93, Lung Volume

Reduction Surgery (Reduction

Pneumoplasty, also called Lung

Shaving, or Lung Contouring) Unilateral

or Bilateral by Open or Thoracoscopic

Approach for Treatment of Emphysema

and Chronic Obstructive Pulmonary

Disease-Not Covered.—This instruction

explains Medicare’s position of

noncoverage for lung volume reduction.

The lack of scientific evidence available

at this time concerning the safety and

effectiveness of lung volume reduction

reveals that this procedure cannot be

considered reasonable and necessary

under § 1862(a)(1)(A) of the Social

Security Act.

35–93 Lung Volume Reduction Surgery

(Reduction Pneumoplasty, Also Called

Lung Shaving or Lung Contouring)

Unilateral or Bilateral by Open or

Thoracoscopic Approach for Treatment

of Emphysema and Chronic Obstructive

Pulmonary Disease-Not Covered

Lung volume reduction surgery or

reduction pneumoplasty, also referred

to as lung shaving or lung contouring,

is performed on patients with

emphysema and chronic obstructive

pulmonary disease (OPD) in order to

allow the underlying compressed lung to

expand, and thus, establish improved

respiratory function. The goal of this

procedure is to offer a better quality of

life for patients with emphysema and

OPD. In addition, lung volume

reduction may be offered as a ‘‘bridge to

transplant’’ for patients who otherwise

may not have been considered

candidates for lung transplantation.

Unilateral or bilateral lung volume

reduction surgery by open or

thoracoscopic approach is not covered

because there is little medical evidence

available to base a determination that

this procedure is safe and effective.

Therefore, lung volume reduction

surgery cannot be considered

reasonable and necessary under

§ 1862(a)(1)(A) of the law. When more

scientific evidence becomes available,

this policy will be reevaluated.

ADDENDUM V.—REGULATION DOCUMENTS PUBLISHED IN THE FEDERAL REGISTER

Publication

date

FR Vol. 60

page CFR part File code 1 Regulation title

End of

comment

period

Effective

date

10/02/95 ...... 51483–51487 ........................... ORD–079–N ....... New and Pending Demonstration Project Proposals Submitted Pursuant to Section

1115(a) of the Social Security Act: June

1995.

................ 10/02/95

10/06/95 ...... 52396–52403 ........................... BPD–797–PN ...... Medicare Program: Limitations on Medicare

Coverage of Cataract Surgery.

12/05/95 ....................

10/10/95 ...... 52684–52688 ........................... ORD–080–N ....... New and Pending Demonstration Project Proposals Submitted Pursuant to Section

1115(a) of the Social Security Act: July

1995.

................ 10/10/95

10/10/95 ...... 52731 489, 498 ........... HSQ–156–CN ..... Medicare and Medicaid Programs; Survey,

Certification and Enforcement of Skilled

Nursing Facilities and Nursing Facilities;

Correction.

................ 07/01/95

10/13/95 ...... 53456 489 ................... HSQ–156–CN ..... Medicare and Medicaid Programs; Survey,

Certification and Enforcement of Skilled

Nursing Facilities and Nursing Facilities;

Correction.

................ 07/01/95

10/16/95 ...... 53625–53626 ........................... OACT–049–N ..... Medicare Program; Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts for 1996................. 01/01/96

10/16/95 ...... 53626–53631 ........................... OACT–050–N ..... Medicare Program; Monthly Actuarial Rates

and Monthly Supplementary Medical Insurance Premium Rate Beginning January 1,

1996.

................ 01/01/96

10/16/95 ...... 53631–53632 ........................... OACT–051–N ..... Medicare Program; Part A Premium for 1996

for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted

Other Entitlement.

................ 01/01/96

10/18/95 ...... 53876–53877 411 ................... BPD–482–CN ..... Medicare Program; Medicare Secondary

Payer for Individuals Entitled to Medicare

and Also Covered Under Group Health

Plans; Correction.

................ 09/29/95

10/18/95 ...... 53877 414 ................... BPD–830–F ........ Medicare Program; Authority Citations; Technical Amendments................. 09/29/95

10/18/95 ...... 53877 486 ................... BPD–836–F ........ Medicare Program; Suppliers of Specialized

Services; Technical Amendment.

................ 09/29/95

11/15/95 ...... 57435–57448 ........................... BPO–132–N ........ Medicare and Medicaid Programs; Quarterly

Listing of Program Issuances and Coverage

Decisions—Second Quarter 1995.

................ 11/15/95

11/28/95 ...... 58631–58632 ........................... OPL–007–N ........ Medicare Program; December 11, 1995 Meeting of the Practicing Physicians Advisory

Council.

................ 11/28/95
33128 Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Notices

ADDENDUM V.—REGULATION DOCUMENTS PUBLISHED IN THE FEDERAL REGISTER—Continued

Publication

date

FR Vol. 60

page CFR part File code 1 Regulation title

End of

comment

period

Effective

date

11/29/95 ...... 61264–61265 ........................... BPD–820–N ........ Medicare Program; Notice Containing the

Statement Drafted by the Committee Established to Negotiate the Wage Index To Be

Used to Adjust Hospice Payment Rates

Under Medicare.

................ 11/29/95

11/30/95 ...... 61483–61487 ........................... MB–085–F .......... Medicare Program; Nurse-Midwife Services .... ................ 01/02/96

12/01/95 ...... 61704–61705 ........................... OPL–008–N ........ Medicare Program; Request for Nominations

for Members for the Practicing Physicians

Advisory Council.

................ 12/01/95

12/05/95 ...... 62237–62241 413 ................... BPD–788–P ........ Medicare Program; Uniform Electronic Cost

Reporting for Skilled Nursing Facilities and

Home Health Agencies.

02/05/96 ....................

12/08/95 ...... 63124–63357 400, 405, 410,

411, 412, 413,

414, 415, 417,

489.

BPD–827–FC ...... Medicare Program; Revisions to Payment Policies and Adjustments to the Relative Value

Units Under the Physician Fee Schedule for

Calendar Year 1996.

02/06/96 2 01/01/96

12/08/95 ...... 63358–63366 ........................... BPD–828–FN ...... Medicare Program; Physician Fee Schedule

Update for Calendar Year 1996 and Physician Volume Performance Standard Rates

of Increase for Federal Fiscal Year 1996.

................ 3 10/01/95

12/11/95 ...... 63438–63440 411 ................... BPD–850–F ........ Medicare Program; Physician Self-Referral

Regulations: Change in Date for Submission

of Group Attestation Statement.

................ 12/11/95

12/11/95 ...... 63440–63444 424 ................... BPD–838–FC ...... Medicare Program; Additional Supplier Standards.02/09/96 01/01/96

12/11/95 ...... 63532–63536 ........................... ORD–081–N ....... New and Pending Demonstration Project Proposals Submitted Pursuant to Section

1115(a) of the Social Security Act: August

and September 1995.

................ 12/11/95

12/15/95 ...... 64440–64444 ........................... ORD–082–N ....... New and Pending Demonstration Project Proposals Submitted Pursuant to Section

1115(a) of the Social Security Act: October

1995.

................ 12/15/95

1GN—General Notice; PN—Proposed Notice, FN—Final Notice; P—Notice of Proposed Rulemaking (NPRM); F—Final Rule; FC—Final Rule

with Comment Period; CN—Correction Notice; SN—Suspension Notice; WN—Withdrawal Notice; NR—Notice of HCFA Ruling. 2Except CFR Part 415, 07/01/96.

3For Volume Performance Standard Rates of Increase; 01/01/96 for Medicare Physician Fee Schedule Update.

Addendum VI—Categorization of Food

and Drug Administration-Approved

Investigational Device Exemptions

Under the Food, Drug, and Cosmetic

Act (21 U.S.C. 360c), devices fall into

one of three classes:

Class I—Devices for which the general

controls of the Food, Drug, and

Cosmetic Act, such as adherence to

good manufacturing practice

regulations, are sufficient to provide a

reasonable assurance of safety and

effectiveness.

Class II—Devices that, in addition to

general controls, require special

controls, such as performance standards

or postmarket surveillance, to provide a

reasonable assurance of safety and

effectiveness.

Class III—Devices that cannot be

classified into Class I or Class II because

insufficient information exists to

determine that either special or general

controls would provide reasonable

assurance of safety and effectiveness.

Class III devices require premarket

approval.

Under the new categorization process

to assist HCFA, the Food and Drug

Administration assigns each device with

a Food and Drug Administrationapproved investigational device

exemption to one of two categories:

Experimental/Investigational (Category

A) Devices, or Non-Experimental/

Investigational (Category B) Devices.

Under this categorization process, an

experimental/investigational (Category

A) device is an innovative device in

Class III for which ‘‘absolute risk’’ of the

device type has not been established

(that is, initial questions of safety and

effectiveness have not been resolved

and the Food and Drug Administration

is unsure whether the device type can

be safe and effective). A nonexperimental/investigational (Category

B) device is a device believed to be in

Class I or Class II, or a device believed

to be in Class III for which the

incremental risk is the primary risk in

question (that is, underlying questions

of safety and effectiveness of that device

type have been resolved), or it is known

that the device type can be safe and

effective because, for example, other

manufacturers have obtained Food and

Drug Administration approval for that

device type.

There were no new FDA-approved

IDE device numbers in Category A to

report for this quarter.

The criteria the Food and Drug

Administration uses to categorize an

investigational device under Category B

include the following:

(1) Devices, regardless of the

classification, under investigation to

establish substantial equivalence to a

predicate device, that is, to establish

substantial equivalence to a previously/

currently legally marketed device.

(2) Class III devices whose

technological characteristics and

indication for use are comparable to a

PMA-approved device.

(3) Class III devices with

technological advances compared to a

PMA-approved device, that is, a device

with technological changes that

represent advances to a device that has
Federal Register / Vol. 61, No. 124 / Wednesday, June 26, 1996 / Notices 33129

already received PMA-approval

(generational changes).

(4) Class III devices that are

comparable to a PMA-approved device

but are under investigation for a new

indication for use. For purposes of

studying the new indication, no

significant modification to the device

were required.

(5) Pre-amendments Class III devices

that become the subject of an

investigational device exemption after

the Food and Drug Administration

requires premarket approval, that is, no

PMA application was submitted or the

PMA application was denied.

(6) Nonsignificant risk device

investigations for which the Food and

Drug Administration required the

submission of an investigational device

exemption.

The following information presents

the device number, category (in this

case, B), and criterion code.

G950165 B3

G950167 B2

G950169 B3

G950170 B4

G950172 B3

G950173 B1

G950174 B4

G950179 B1

G950180 B1

G950181 B1

G950183 B3

G950184 B1

G950187 B2

G950188 B1

G950189 B1

G950190 B4

G950191 B4

G950192 B6

G950193 B4

G950195 B1

G950196 B4

G950197 B3

G950198 B1

G950201 B1

G950202 B4

G950206 B1

G950208 B3

G950209 B4

Note: Some investigational devices may

exhibit unique characteristics or raise safety

concerns that make additional consideration

necessary. For these devices, HCFA and the

Food and Drug Administration will agree on

the additional criteria to be used. The Food

and Drug Administration will use these

criteria to assign the device(s) to a category.

As experience is gained in the categorization

process, this addendum may be modified.

[FR Doc. 96–16217 Filed 6–25–96; 8:45 am]

BILLING CODE 4120–01–P

[BPD–873–N]

Medicare Program; Announcement of

Collaborative Effort With the National

Institutes of Health to Study the

Effectiveness of Lung Volume

Reduction Surgery

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

We are announcing our participation

in a collaborative effort with the

National Heart, Lung and Blood

Institute of the National Institutes of

Health to study the effectiveness of lung

volume reduction surgery. The purpose

of this multi-centered randomized

study, which will include a prospective

registry examining the role of lung

volume reduction surgery, is to evaluate

the long-term outcome of the procedure

on function, morbidity, and mortality as

well as to define appropriate patient

selection criteria. We are issuing this

announcement so that interested

facilities and providers who monitor the

Federal Register are aware of this

collaborative effort. The National Heart,

Lung and Blood Institute announced in

the May 9 and 10, 1996 issues of the

Commerce Business Daily the

qualifications and experience required

for the clinical centers and the clinical

coordinating center to participate in the

program. It also described the patient

population who will be included in the

study and how the study will be

conducted.

On June 3, 1996, the National Heart,

Lung and Blood Institute made available

a formal request for proposals for

clinical centers and a clinical

coordinating center interested in

participating in the study through the

National Institutes of Health (NIH)

Request for Proposals (RFP) Gopher.

Users have access via the NIH Home

Page (World Wide Web) at http://

www.nih.gov. Once users are at the NIH

Home Page, they should select ‘‘Grants

& Contracts,’’ then select ‘‘R&D Requests

for Proposals (RFP).’’ Offerors that have

access to the NIH Gopher Server but not

the Internet can access the RFP by

pointing their gopher clients to

GOPHER.NIH.GOVPORT70. They

should select ‘‘Grant and Research

Information,’’ then select ‘‘R&D

Requests for Proposals (RFP).’’

FOR FURTHER INFORMATION CONTACT:

Karen McVearry, (410) 786–4643.

Authority: Sections 1102 and 1871 of the

Social Security Act (42 U.S.C. 1302 and

1395hh)

(Catalog of Federal Domestic Assistance

Program No. 93.774, Medicare—

Supplementary Medical Insurance Program)

Dated: June 9, 1996.

Bruce C. Vladeck,

Administrator, Health Care Financing

Administration.

[FR Doc. 96–16216 Filed 6–25–96; 8:45 am]

BILLING CODE 4120–01–P

National Institutes of Health

National Cancer Institute; Notice of

Meeting of the National Cancer

Advisory Board

Pursusant to Section 10(d) of the

Federal Advisory Committee act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the meeting of the

National Cancer Advisory Board,

National Cancer Institute on July 18,

1996. The meeting will be open to the

public and attendance by the public will

be limited to space available.

The Committee Management Office,

National Cancer Institute, National

Institutes of Health, Executive Plaza

North, Room 630E, 9000 Rockville Pike,

Bethesda, Maryland 20892 (301/496–

5708), will provide summaries of the

meetings and rosters of the Board

members, upon request.

Individuals who plan to attend and

need special assistance, such as sign

language interpretation or other

reasonable accommodations, should

contact Ms. Carole Frank, Committee

Management Specialist, at 301/496–

5708 in advance of the meeting.

Name of Committee: National Cancer

Advisory Board.

Contact Person: Dr. Marvin R. Kalt,

Executive Secretary, National Cancer

Institute, NIH, Executive Plaza North,

Room 600A, 6130 Executive Blvd.,

Bethesda, MD 20892–7405; (301) 496–

5147.

Date of Meeting: July 18, 1996.

Place of Meeting: National Cancer

Institute via telephone conference,

National Institutes of Health, Room 640,

6130 Executive Blvd., Rockville, MD

20852.

Open: 1 pm to approximately 2 pm.

Agenda: To discuss the NCAB

resolution for the 25th Anniversity of

the National Cancer Act.

Dated: June 21, 1996.

Susan K. Feldman,

Committtee Management Officer, NIH.

[FR Doc.96–16323 Filed 6–25–96; 8:45 am]

BILLING CODE 4140–01–M

Office of Extramural Research; Notice

of Meeting

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice