Medicare and Medicaid Programs; Quarterly Listing of Program Issuances and Coverage DecisionsFirst Quarter 1996

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

[BPO-139-N]

Medicare and Medicaid Programs; Quarterly Listing of Program

Issuances and Coverage Decisions--First Quarter 1996

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 January, February, and

March of 1996 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. Generally, we

also provide the content of revisions to the Medicare Coverage Issues

Manual. There were no revisions published during the period January 1

through March 31, 1996. 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 Administration-

approved 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

substantive and interpretive regulations published during January

through March 1996.

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 many of 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

[[Page 40237]]

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 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

[[Page 40238]]

World Wide Web--the Superintendent of Documents home page address is

http://www.access.gpo.gov/su__docs/; (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 [email protected]

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 ``Beneficiary

Address Change,'' use the Superintendent of Documents No. HE 22.8/7 and

the HCFA transmittal number 1538.

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: July 19, 1996.

Carol J. 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 154)

June 26, 1996 (61 FR 33119)

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.

[[Page 40239]]

Addendum III--Medicare and Medicaid Manual Instructions January Through

March 1996

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

Trans. No. Manual/Subject/Publication Number

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

Intermediary Manual

Part 3--Claims Process (HCFA Pub. 13-3)

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

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

1671................... Claims Processing Terminology.

Handling Incomplete or Invalid Claims.

Data Element Requirements Matrix.

1672................... PRO Reporting on Medical Review.

1673................... Guidelines for Review of Claims for

Epoetin.

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

Carriers Manual

Part 3--Claims Process (HCFA Pub. 14-3)

(Superintendent of Documents No. HE 22.8/7)

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

1533................... Nomenclature and Organization of the

List.

Rebundling of CPT Codes.

Added ASC Codes.

1534................... Positron Emission Tomography Scans.

Billing Requirements for PET Scans.

Claims Processing Instructions for PET Scan

Claims.

1535................... Claims Processing Terminology.

Handling Incomplete or Invalid Claims.

Data Element Requirements Matrix.

Conditional Data Element Requirements.

1536................... Reasonableness and Necessity.

1537................... Item 24--Type of Service.

1538................... Beneficiary Address Change.

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

Carriers Manual

Part 4--Professional Relations (HCFA Pub. 14-4)

(Superientendent of Documents No. HE 22.8/7-4)

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

11..................... Items 1-13--Patient and Insured

Information.

Items 14-33--Physician or Supplier

Information.

Place of Service Codes and Definitions.

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

Program Memorandum

Intermediaries/Carriers (HCFA Pub. 60B)

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

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

B-96-1................. Coverage for Occupational Therapists

in Independent Practice.

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

Progam Memorandum

Carriers (HCFA Pub. 60A/B)

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

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

AB-96-1................ New Interest Rate Payable on Clean

Claims Not Paid Timely.

AB-96-2................ Exclusion Process, Sec. 1128(b)(7).

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

Progam Memorandum

Insurance Commissioners (HCFA Pub. 80)

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

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

96-1................... Medigap Bulletin Series (Number Five).

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

Peer Review Organization

(HCFA Pub. 19)

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

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

58..................... Background.

Beneficiary Hotline.

Interaction with Beneficiary Groups.

Other Activities.

59..................... PRO Reporting on Medical Review.

Tracking Adjustments.

PRO/Intermediary/Carrier Coordination

Activities.

Additional PRO/Carrier Coordination

Activities.

60..................... Background.

[[Page 40240]]

PRO Review Responsibilities.

Types of Prohibited Actions That Circumvent

PPS.

Actions to be Taken by PRO.

Authority.

Types of Denial Determinations.

Notification of Denial.

Content of Denial Notice.

Statutory and Regulatory Requirements.

Requests for Reconsideration.

Reconsideration Process.

Circumvention of Prospective Payment System.

Background.

Appeals Council Review.

Judicial Review.

Circumvention of PPS Denial Model Notice.

Circumvention of PPS Reconsideration Model

Notice.

61..................... Training.

Citations and Authority.

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

Hospice Manual

(HCFA Pub. 21)

(Superintendent of Documents No. HE 22.8/18)

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

47..................... Credit Balance Reporting Requirements.

Payment of Amounts Owed Medicare.

Medicare Credit Balance Report Certification.

Medicare Credit Balance Report (HCFA-838)

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

Provider Reimbursement Manual

Part 1--(HCFA Pub.15-1)

(Superintendent of Documents No. HE 22.8/4)

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

389.................... Travel Expense.

390.................... Regional Medicare Swing-Bed SNF Rates.

391.................... Interest.

Necessary.

Accounts Receivable Financing.

Costs Included in Capital-Related Costs.

Capital Related Costs of Related

Organizations.

Debt Issuance Costs, Debt Discounts, and Debt

Redemption Costs.

Costs Excluded From Capital-Related Costs.

Jointly Owned Equipment.

Unpaid Compensation.

392.................... Ambulance Service.

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

Medicare/Medicaid

Sanction--Reinstatement Report

(HCFA Pub. 69)

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

96-1................... Cumulative Report of Physicians/

Practitioners, Providers and/or Other Health

Care Suppliers Sanctioned/Reinstated.

96-2................... Report of Physicians/Practioners,

Providers and/or Other Health Care Suppliers

Excluded/Reinstated--December 1995 and January

1996.

96-3................... Report of Physicians/Practitioners,

Providers and/or Other Health Care Suppliers/

Reinstated--February 1996.

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

Addendum IV

There are no revisions to the Coverage Issues Manual for this

quarter.

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

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

End of

Publication date FR Vol. 61 CFR Part File code * Regulation comment Effective

page title period date

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

01/19/96......... 1389-1390 ................ BPD-854-NC Medicare and 03/19/96 01/19/96

Medicaid

Programs;

Announcement

of

Applications

from Hospitals

Requesting

Waivers for

Organ

Procurement

Service Area.

01/23/96......... 1769-1772 ................ ORD-083-N New and Pending ........... ...........

Demonstration

Project

Proposals

Submitted

Pursuant to

Section

1115(a) of the

Social

Security Act:

November 1995.

[[Page 40241]]

01/26/96......... 2516-2519 ................ BPO-134-NC Medicare 02/26/96 02/01/96

Program;

Revised

Criteria and

Standards for

Evaluating

Durable

Medical

Equipment,

Prosthetics,

Orthotics, and

Supplies

Regional

Carriers'

Performance

Beginning

February 1,

1996.

01/26/96......... 2516 ................ ORD-078-N Medicare ........... ...........

Program;

Announcement

of Funding

Availability

for a

Cooperative

Agreement for

an End-Stage

Renal Disease

(ESRD) Managed

Care

Demonstration.

01/29/96......... 2725-2727 412, 413........ BPD-825-FCN Medicare ........... 10/01/95

Program;

Changes to the

Hospital

Inpatient

Prospective

Payment

Systems and

Fiscal Year

1996 Rates;

Corrections.

02/27/96......... 7266 ................ ORD-084-N New and Pending ........... ...........

Demonstration

Project

Proposals

Submitted

Pursuant to

Section

1115(a) of the

Social

Security Act:

December 1995.

02/29/96......... 7798 ................ ORD-085-N New and Pending ........... ...........

Demonstration

Project

Proposals

Submitted

Pursuant to

Section

1115(a) of the

Social

Security Act:

January 1996.

03/08/96......... 9405-9410 440............. MB-071-P Medicare 05/07/96 ...........

Program;

Coverage of

Personal Care

Services.

03/27/96......... 13430-1345 417,434......... OMC-010-FC Medicare and 05/28/96 04/26/96

0 Medicaid

Programs;

Requirements

for Physician

Incentive

Plans in

Prepaid Health

Care

Organizations.

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

* GN--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.

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

Administration-approved 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 non-experimental/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.

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 Pre-Market Approval (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 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, A), and criterion code. G950168 A2, G950175 A1, G960026 A2,

G960033 A1, G960034 A1, G960055 A2, G960060 A1, G960066 A2

The following information presents the device number, category (in

this case, B), and criterion code. G950194 B1, G950210 B1, G950212 B3,

G950217 B1, G950218 B1, G950229 B3, G950231 B, G960003 B4, G960018 B4,

G960019 B4, G960021 B2, G960022 B4, G960023 B2, G960024 B3, G960025 B2,

G960027 B4, G960028 B1, G960029 B4, G960030 B2, G960031 B2, G960035 B4,

G960037 B4, G960038 B4, G960041 B4, G960043

[[Page 40242]]

B1, G960046 B1, G960051 B3, G960054 B3, G960056 B5, G960057 B2, G960059

B2, G960061 B2, G960062 B2

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. 96-19559 Filed 7-31-96; 8:45 am]

BILLING CODE 4120-01-P