Medicare and Medicaid Programs; Quarterly Listing of Program IssuancesThird Quarter 1996

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

[BPO-141-N]

Medicare and Medicaid Programs; Quarterly Listing of Program

Issuances--Third 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 that were

published during July, August, and September 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.

FOR FURTHER INFORMATION CONTACT:

Bridget Wilhite, (410) 786-5248 (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).

[[Page 19329]]

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, and guidelines of general

applicability not issued as regulations. We published our first notice

June 9, 1988 (53 FR 21730).

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 July

through September 1996.

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 and are initiating the inclusion of HCFA Rulings.

II. How To Use the Addenda

This notice is organized so that a reader may review the subjects

of all manual issuances, memoranda, substantive and interpretive

regulations, or Food and Drug Administration-approved investigational

device exemptions published during the 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 lists the publication dates of the

most recent quarterly listing of program issuances.

Addendum II identifies previous Federal Register documents that

contain a description of all previously published HCFA Medicare and

Medicaid manuals and memoranda.

Addendum III 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 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).

Addendum V lists a HCFA Ruling that was issued during the period

covered by this notice. A HCFA ruling which is a statement of policy or

interpretation that has not been published in the Federal Register as

part of a regulation or of a notice implementing regulations, but which

has been adopted by HCFA as having precedent.

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 covered by the notice.

III. 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, A TTN: New

Orders, P.O. Box 371954, Pittsburgh, PA 15250-7954, Telephone (202)

512-1800, Fax number (202) 512-2250 (for credit card orders); or

National Technical Information Service, Department of Commerce, 5825

Port Royal Road, Springfield, VA 22161, Telephone (703) 487-4630.

In addition, individual manual transmittals and Program Memoranda

listed in this notice can be purchased from NTIS. Interested parties

should identify the transmittal(s) they want. GPO or NTIS can give

complete details on how to obtain the publications they sell.

Additionally, all manuals are available at the following Internet

address: http//www.hcfa.gov/pubforms/progman.htm.

B. Regulations and Notices

Regulations and notices are published in the daily Federal

Register. Interested individuals may purchase individual copies or

subscribe to the Federal Register by contacting the GPO at the address

given above. When ordering individual copies, it is necessary to cite

either the date of publication or the volume number and page number.

The Federal Register is also available on 24 x 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)

[[Page 19330]]

through the Internet and via asynchronous dial-in. Internet users can

access the database by using the World Wide Web; the Superintendent of

Documents home page address is http://www.access.gpo.gov/su__docs/, by

using local WAIS client software, or by telnet to swais.access.gpo.gov,

then log in as guest (no password required). Dial-in users should use

communications software and modem to call (202) 512-1661; type swais,

then log in as guest (no password required).

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.

IV. How To Review Listed Material

Transmittals or Program Memoranda can be reviewed at a local

Federal Depository Library (FDL). Under the FDL program, government

publications are sent to approximately 1,400 designated libraries

throughout the United States. 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 Intermediary Manual, Part

1--Fiscal Administration (HCFA Pub. 13-1) transmittal entitled

``Electronic Remittance Advice,'' use the Superintendent of Documents

No. HE 22.8/6-3 and the HCFA transmittal number 127.

V. 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 Addendum III may be

addressed to Bridget Wilhite, Bureau of Program Operations, Issuances

Staff, Health Care Financing Administration, N2-05-03, 7500 Security

Boulevard, Baltimore, 21244-1850, Telephone (410) 786-5248.

Questions concerning Medicaid items in Addendum 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

Boulevard, 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, C5-12-16, 7500 Security

Boulevard, 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: April 10, 1997.

Gary Kavanagh,

Acting Director, Bureau of Program Operations.

Addendum I

This addendum lists the publication dates of the most recent

quarterly listings of program issuances.

July 26, 1995 (60 FR 38344)

November 15, 1995 (60 FR 57435)

April 8, 1996 (61 FR 15491)

June 26, 1996 (61 FR 33119)

December 18, 1996 (61 FR 66676)

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 19331]]

Addendum III--Medicare and Medicaid Manual Instructions

[July through September 1996]

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

Trans. No. Manual/Subject/Publication Number

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

Intermediary Manual

Part 1--Fiscal Administration (HCFA Pub. 13-1)

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

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

127 http://www.hcfa.gov/pubforms/pub6/

pub6toc.htm.

Transmittal No. 88

Clarification--Effective Date: Not Applicable.

Section 50-41, Human Tumor Stem Cell Drug Sensitivity Assays,

clarifies that while the fluorescent cytoprint assay (FCA) is not based

upon the same or a similar procedure as the human tumor stem cell drug

sensitivity assay, it is sufficiently alike that it is included under

this subject. The basic difference is that the FCA incorporates the use

of microorgan systems and a fluorescent dye. The test is performed as

an in vitro chemosensitivity test for the effectiveness of drugs for

cancer treatment. Medicare considers the clinical application of this

procedure as experimental and not covered by the program at this time.

Transmittal No. 89

Changed Implementing Instructions--Effective Date: For services

furnished on or after 10/07/96.

[[Page 19335]]

Section 65-9, Incontinence Control Devices, is revised to reflect

that in female patients the Abdominal Leak Point Pressure (ALPP)

measurement is amended from less than 65 cm H20 to an ALPP of less

than 100 cm HH20, if the diagnosis of intrinsic sphincter

deficiency (ISD) is established. HCFA is amending the leak point

pressure measurement in female patients without urethral hypermobility

and with abdominal leak point pressures of 65 cm H20 to 100 cm

H20.

For patients whose incontinence showed no improvement after the

initial five treatments, no further treatments are covered. HCFA is

amending the lifetime limitation of five treatment sessions for

patients who have received successful treatments in the past to allow

latitude for the treating physician to decide whether additional

sessions of collagen injection may be beneficial. For these patients,

medical documentation must accompany claims for additional treatments

beyond five. HCFA is deleting the requirement that patients must have

shown no improvement in their incontinence for at least 12 months prior

to collagen therapy in order to be eligible for coverage.

In addition, the coverage guidelines for pelvic floor stimulators

that were previously in Sec. 65-11 under the bladder stimulators policy

are being moved to Sec. 65-9 since pelvic floor stimulators are more

appropriately identified as incontinence control devices. Section 65-9

is also revised to indicate that pelvic floor stimulators are not

covered for the reason that the effectiveness of these devices is

unproven. The previous policy in Sec. 65-11 indicated that both the

safety and effectiveness of pelvic floor stimulators were unproven.

Section 65-11, Bladder Stimulators, is revised to eliminate the use

of name brand products. HCFA now identifies devices according to a

general categorization of products rather than by specific brand names.

In addition, the coverage guidelines for pelvic floor stimulators have

been moved to Sec. 65-9.

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

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

End of

Publication date FR vol. 61 page CFR part(s) File code* Regulation title comment Effective

period date

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

07/01/96............... 33928-33936 ........................... BPD-847-CN Medicare Program; Changes ........... ...........

to the Hospital Inpatient

Prospective Payment

Systems and Fiscal Year

1997 Rates; Correction.

07/01/96............... 34344-34365 ........................... BPD-867-NC Medicare Program; Schedule 08/30/96 070196

of Limits on Home Health

Agency Costs Per Visit

for Cost Reporting

Periods Beginning on or

After July 1, 1996.

07/02/96............... 34614-34662 405, 410, 415 BPD-852-P Medicare Program; 09/03/96 ...........

Revisions to Payment

Policies Under the

Physician Fee Schedule

for Calendar Year 1997.

07/05/96............... 35307 405, 417, 431, 473, 498 BPD-704-FC Medicare and Medicaid ........... 07/24/96

Programs; Provider

Appeals; Technical

Amendments; Correction.

07/16/96............... 37011-37015 413 BPD-647-F Medicare Program; ........... 08/15/96

Reporting of Interest

From Zero Coupon Bonds.

07/23/96............... 38207-38212 ........................... BPD-849-PN Medicare Program; 08/22/96 ...........

Recognition of the

Ambulatory Surgical

Center Standards of the

Joint Commission on the

Accreditation of

Healthcare Organizations

and the Accreditation

Association for

Ambulatory Health Care.

07/24/96............... 38395-38399 ........................... MB-099-F Medicaid Program; Medicaid ........... 08/23/96

Eligibility Quality

Control, Progressive

Reductions in Federal

Financial Participation

for FYs 1982-1984,

Payment for Physician

Billing for Clinical

Laboratory Services, and

Utilization Control of

Skilled Nursing Facility

Services: Removal of

Obsolete Requirements.

07/24/96............... 38395 417 OMC-009-FC Medicare Program; ........... 10/01/95

Qualified Health

Maintenance

Organizations; Correction.

08/01/96............... 40236-40242 ........................... BPO-139-N Medicare and Medicaid ........... ...........

Programs; Quarterly

Listing of Program

Issuances and Coverage

Decisions-First Quarter

1996.

08/02/96............... 40343-40347 406, 407, 408, 416 BPD-752-FC Medicare Program; Special 10/01/96 09/03/96

Enrollment Periods and

Waiting Period.

08/15/96............... 42385-42386 417, 473, 498 BPD-704-CN Medicare and Medicaid ........... 07/24/96

Programs: Provider

Appeals; Technical

Amendments; Corrections.

08/15/96............... 42385 415 BPD-827-CN Medicare Program; ........... \1\ 01/01/

Revisions to Payment 96

Policies and Adjustments

to the Relative Value

Units Under the Physician

Fee Schedule for Calendar

Year 1996; Correction.

[[Page 19336]]

08/16/96............... 42637-42638 ........................... ORD-090-N New and Pending ........... ...........

Demonstration Project

Proposals Submitted

Pursuant to Section

1115(a) of the Social

Security Act: June 1996.

08/30/96............... 46166-46328 412, 413, 489 BPD-847-F Medicare Program; Changes ........... 10/01/96

to the Hospital Inpatient

Prospective Payment

Systems and Fiscal Year

1997 Rates.

09/03/96............... 46466-46478 ........................... BPD-842-NC Medicare Program; Schedule 11/04/96 10/01/96

of Prospectively

Determined Payment Rates

for Skilled Nursing

Facility Inpatient

Routine Service Costs.

09/03/96............... 46384-46385 417 OMC-010-FC Medicare and Medicaid 11/04/96 09/03/96

Programs; Requirements

for Physician Incentive

Plans in Prepaid Health

Care Organizations;

Correction.

09/04/96............... 46579-46603 418 BPD-820-P Medicare Program; Hospice 11/04/96 ...........

Wage Index.

09/09/96............... 47423-47434 482 BPD-633-F Medicare and Medicaid ........... 11/08/96

Program; Hospital

Standard for Potentially

HIV Infectious Blood and

Blood Products.

09/11/96............... 47946-47950 ORD-091-N New and Pending .......................... ...........

Demonstration Project

Proposals Submitted

Pursuant to Section

1115(a) of the Social

Security Act

09/11/96............... 47950-47951 ........................... OPL-011-N Medicare Program; ........... ...........

September 30, 1996

Meeting of the Practicing

Physicians Advisory

Council.

09/19/96............... 49269-49271 401, 405 BPD-869-F Medicare Program; Waiver ........... 10/21/96

of Recovery of

Overpayments.

09/19/96............... 49271-49276 421 BPO-105-F Medicare Program; Part B ........... 10/21/96

Advance Payments to

Suppliers Furnishing

Items or Services Under

Medicare Part B.

09/23/96............... 49781-49785 ........................... MB-100-N Medicaid Program; Final ........... ...........

Limitations on Aggregate

Payments to

Disproportionate Share

Hospitals; Federal Fiscal

Year 1996.

09/26/96............... 50493 ........................... ORD-092-N New and Pending

Demonstration Project

Proposals Submitted

Pursuant to Section

1115(a) of the Social

Security Act: August 1996.

09/30/96............... 51021 ........................... BPD-704-CN Medicare and Medicaid ........... 07/24/96

Programs; Provider

Appeals: Technical

Amendments; Correction.

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

\1\ And 07/01/96 (part 415 only).

Addendum V.--HCFA Ruling

HCFAR-96-1 Medicare Program; Medicare Supplementary Medical

Insurance (Part B); Clarification of the Terms ``Orthotics,''

``Braces,'' and ``Durable Medical Equipment'' under Medicare Part B.

Issued September 18, 1996.

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

[[Page 19337]]

(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 modifications 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.

G960032 A1

G960055 A

G960069 A2

G960125 A1

G960140 A2

G960143 A2

G960154 A2

G960169 A2

The following information presents the device number category (in

this case, B), and criterion code.

G940026 B

G950128 B3

G960005 B1

G960022 B2

G960050 B2

G960059 B2

G960077 B3

G960080 B3

G960092 B4

G960114 B4

G960116 B4

G960117 B2

G960120 B1

G960121 B3

G960122 B2

G960123 B1

G960126 B2

G960127 B4

G960128 B1

G960129 B3

G960130 B

G960132 B4

G960133 B2

G960135 B1

G960136 B2

G960139 B4

G960141 B

G960142 B2

G960148 B

G960150 B2

G960151 B4

G960152 B4

G960153 B2

G960155 B1

G960156 B

G960157 B

G960158 B4

G960159 B

G960161 B

G960162 B

G960165 B

G960168 B1

G960170 B4

G960171 B3

G960172 B3

G960173 B

G960175 B2

G960176 B1

G960177 B3

G960179 B1

G960180 B4

G960182 B2

G960221 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. 97-10138 Filed 4-18-97; 8:45 am]

BILLING CODE 4120-01-P