Federal Register / Vol. 62, No. 225 / Friday, November 21, 1997 / Notices 62325

room 121, 8800 Wisconsin Ave.,

Bethesda, MD. This meeting will be

held by a telephone conference call. A

speaker telephone will be provided in

the conference room to allow public

participation in the meeting.

Contact Person: Nancy T. Cherry or

Denise H. Royster, Center for Biologics

Evaluation and Research (HFM–21),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852,

301–827–0314, or FDA Advisory

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), code 12388.

Please call the Information Line for upto-date information on this meeting.

Agenda: The committee will discuss

the intramural scientific program of the

Laboratory of Enteric and Sexually

Transmitted Diseases.

Procedure: On December 4, 1997,

from 12:30 p.m. to 1:15 p.m., and 2:30

p.m. to 3:30 p.m., the meeting is open

to the public. Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by November 26, 1997. Oral

presentations from the public will be

scheduled between approximately 2:30

p.m. and 3:30 p.m. Time allotted for

each presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before November 26, 1997, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

requested to make their presentation.

Closed Committee Deliberations: On

December 4, 1997, from 1:15 p.m. to

2:30 p.m., the meeting will be closed to

permit discussion where disclosure

would constitute a clearly unwarranted

invasion of personal privacy (5 U.S.C.

552b(c)(6)). The meeting will be closed

to discuss personal information

concerning individuals associated with

the research program.

FDA regrets that it was unable to

publish this notice 15 days prior to the

December 4, 1997, Vaccines and Related

Biological Products Advisory

Committee meeting. Because the agency

believes there is some urgency to bring

this issue to public discussion and

qualified members of the Vaccines and

Related Biological Products Advisory

Committee were available at this time,

the Commissioner concluded that it was

in the public interest to hold this

meeting even if there was not sufficient

time for the customary 15-day public

notice.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: November 17, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–30613 Filed 11-20-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Vaccine and Related Biological

Products Advisory Committee; Notice

of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). At least one portion of the

meeting will be closed to the public.

Name of Committee: Vaccines and

Related Biological Products Advisory

Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on December 11, 1997, 10:30 a.m.

to 5:45 p.m., and December 12, 1997, 8

a.m. to 5 p.m.

Location: Holiday Inn Bethesda,

Versailles Ballrooms I and II, 8120

Wisconsin Ave., Bethesda, MD.

Contact Person: Nancy T. Cherry or

Denise H. Royster, Center for Biologics

Evaluation and Research (HFM–21),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852,

301–827–0314, or FDA Advisory

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), code 12388.

Please call the Information Line for upto-date information on this meeting.

Agenda: On December 11, 1997, the

committee will meet in closed session to

discuss trade secret and/or confidential

commercial information relevant to

pending investigational new drug

applications or pending product

licensing applications. On December 12,

1997, in open session, the committee

will consider the safety and efficacy of

a new vaccine for the prevention of

Rotavirus Diarrhea in children. The

vaccine, RotaShieldTM, is made for

infant indication by Wyeth-Lederle

Vaccines and Pediatrics.

Procedure: On December 12, 1997,

from 9:30 a.m. to 5 p.m., the meeting is

open to the public. Interested persons

may present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by December 3, 1997. Oral

presentations from the public will be

scheduled between approximately 1:30

p.m. and 2:30 p.m. Time allotted for

each presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before December 3, 1997, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

requested to make their presentation.

Closed Committee Deliberations: On

December 11, 1997, from 10:30 a.m. to

5:45 p.m., and on December 12, 1997,

from 8 a.m. to 9:30 a.m., the meeting

will be closed to permit discussion and

review of trade secret and/or

confidential information. These portions

of the meeting will be closed to discuss

pending investigational new drug

applications or pending product

licensing applications (5 U.S.C.

552b(c)(4)).

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: November 17, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–30708 Filed 11–20–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[BPO–151–N]

Medicare and Medicaid Programs;

Quarterly Listing of Program

Issuances—Second Quarter 1997

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 April, May, and June

of 1997 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
62326 Federal Register / Vol. 62, No. 225 / Friday, November 21, 1997 / Notices

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).

Betty Stanton, (410) 786–3247 (For

Medicaid instruction information).

Sharon Hippler, (410) 786–4633 (For

Food and Drug Administrationapproved investigational device

exemption information).

Pam Gulliver, (410) 786–4659 (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, 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 April through June 1997.

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 Administrationapproved 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 five

addenda. Addendum I lists the

publication dates of the most recent

quarterly listings of program issuances.

Addendum II identifies previous

Federal Register documents that

contain a description of all previously

published HCFA Medicare and

Medicaid manuals and memoranda.

Addendum III 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).

On September 19, 1995, we published

a final rule (60 FR 48417) establishing

in regulations at 42 CFR 405.201 et seq.

that certain devices with an

investigational device exemption

approved by the Food and Drug

Administration and certain services

related to those devices may be covered

under Medicare. It is HCFA’s practice to

announce in this quarterly notice all

investigational device exemption

categorizations, using the

investigational device exemption

numbers the Food and Drug

Administration assigns. Addendum V

includes listings of the Food and Drug

Administration-approved

investigational device exemption

numbers that have been approved or

revised during the quarter covered by

this notice. The listings are organized

according to the categories to which the

device numbers are assigned (that is,

Category A or Category B, and identified

by the investigational device exemption

number).

III. How to Obtain Listed Material

A. Manuals

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, 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 24x microfiche and as an online

database through GPO Access. The
Federal Register / Vol. 62, No. 225 / Friday, November 21, 1997 / Notices 62327

online database is updated by 6 a.m.

each day the Federal Register is

published. The database includes both

text and graphics from Volume 59,

Number 1 (January 2, 1994) forward.

Free public access is available on a

Wide Area Information Server (WAIS)

through the Internet and via

asynchronous dial-in. Internet users can

access the database by using the World

Wide Web; the Superintendent of

Documents home page address is http:/

/www.access.gpo.gov/suldocs/, by

using local WAIS client software, or by

telnet to swais.access.gpo.gov, then log

in as guest (no password required). Dialin users should use communications

software and modem to call (202) 512–

1661; type swais, then log in as guest

(no password required).

C. Rulings

We publish Rulings on an infrequent

basis. Interested individuals can obtain

copies from the nearest HCFA Regional

Office or review them at the nearest

regional depository library. We have, on

occasion, published Rulings in the

Federal Register. In addition, Rulings,

beginning with those released in 1995,

are available online, through the HCFA

Home Page. The Internet address is

http://www.hcfa.gov/regs/rulings.htm.

D. HCFA’s Compact Disk-Read Only

Memory (CD–ROM)

Our laws, regulations, and manuals

are also available on CD–ROM, 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 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 Intermediary

Manual, Part 2—Audits, Reimbursement

Program Administration (HCFA Pub.

13–2) transmittal entitled ‘‘Maximum

Payment Per Visit For Rural Health

Clinics,’’ use the Superintendent of

Documents No. HE 22.8/6–2 and the

HCFA transmittal number 409.

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, Office of

Communications and Operations

Support, Division of Regulations and

Issuances, Health Care Financing

Administration, Telephone (410) 786–

5248.

Questions concerning Medicaid items

in Addendum III may be addressed to

Betty Stanton, Center for Medicaid State

Operations, Policy Coordination and

Planning Group, Health Care Financing

Administration, C4–25–02, 7500

Security Boulevard, Baltimore, MD

21244–1850, Telephone (410) 786–3247.

Questions concerning Food and Drug

Administration-approved

investigational device exemptions may

be addressed to Sharon Hippler, Office

of Clinical Standards and Quality,

Coverage Analysis Group, 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 Pam

Gulliver, Office of Communications and

Operations Support, Division of

Regulations and Issuances, Health Care

Financing Administration, C5–09–26,

7500 Security Boulevard, Baltimore, MD

21244–1850, Telephone (410) 786–4659.

(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: October 31, 1997.

Pamela J. Gentry,

Director, Office of Communications and

Operations Support.

Addendum I

This addendum lists the publication

dates of the most recent quarterly

listings of program issuances.

June 26, 1996 (61 FR 33119)

December 18, 1996 (61 FR 66676)

April 21, 1997 (62 FR 19328)

May 12, 1997 (62 FR 25957)

November 3, 1997 (62 FR 59358)

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.
62328 Federal Register / Vol. 62, No. 225 / Friday, November 21, 1997 / Notices

ADDENDUM III—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS

[April 1997 through June 1997]

Trans.

No. Manual/Subject/Publication No.

Intermediary Manual

Part 2—Audits, Reimbursement Program Administration

(HCFA Pub. 13–2)

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

409 • Maximum Payment Per Visit For Rural Health Clinics.

• Maximum Payment Per Visit For Freestanding Federally Qualified Health Centers.

410 • List of MR Codes, Categories, and Conversion Factors.

Intermediary Manual

Part 3—Claims Process

(HCFA Pub. 13–3)

(Superintendent of Documents No. HE 22.8/6)

1709 • Pneumococcal Pneumonia, Influenza Virus and Hepatitis B Vaccines.

1710 • Review of Form HCFA–1450 For Inpatient and Outpatient Bills.

Self-Administered Drugs and Biologicals.

Oral Cancer Drugs.

Self-Administered Antiemetic Drugs.

Mammography Quality Standards Act.

Self-Administered Drug Administered In An Emergency Situation.

Hospital Outpatient Partial Hospitalization Services.

1711 • Special Consideration When Processing ESRD Bills Under Method I.

Special Consideration When Processing ESRD Bills Under Method II.

Medical—Subject to Waiver.

1712 • Drugs and Biologicals.

1713 • Pneumoccal Pneumonia, Influenza Virus, and Hepatitis B Vaccines.

1714 • Laboratory Test for Hemodialysis, Intermittent Peritoneal Dialysis, Continuous Cycling Peritoneal Dialysis, and Hemofiltration.

Carriers Manual

Part 3—Claims Process (HCFA Pub. 14–3)

(Superintendent of Documents No. HE 22.8/7)

1564 • Coverage of Supplies and Accessories.

New Supplier Effective Billing Date.

1565 • Assignment of a Partially Paid Bill.

1566 • Method for Computing Fee Schedule Amount.

Bundled Services/Supplies.

Supervising Physicians in Teaching Settings.

Anesthesia Claims Modifiers.

Services of Portable X-ray Suppliers.

Special Situations.

Interpretation of Diagnostic Tests.

1567 • Completing Quarterly Report on Provider Enrollment.

1568 • Screening Mammography Examinations.

Identifying a Screening Mammography Claim.

Adjudicating the Claim.

1569 • Bill Review of Laboratory Services.

1570 • Self-Administered Drug and Biologicals.

1571 • Paper Remittance Notice.

1572 • Bill Review of Laboratory Services.

Program Memorandum

Intermediaries (HCFA Pub. 60A)

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

A–97–4 • Two Month Extension for Implementation of Filing Electronically Prepared Cost Reports for Skilled Nursing Facilities and Home

Health Agencies.

Program Memorandum

Intermediaries/Carriers (HCFA Pub. 60A/B)

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

AB–97–

6

• Current Status of Medicare Program Memorandums And Letters Issued Before Calendar Year 1997.

AB–97–

7

• Revision on Program Memorandum Transmittal No. AB–97–5, New Panels Approved by CPT.

AB–97–

8

• Hematocrit Levels for Erythropoietin.
Federal Register / Vol. 62, No. 225 / Friday, November 21, 1997 / Notices 62329

ADDENDUM III—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS—Continued

[April 1997 through June 1997]

Trans.

No. Manual/Subject/Publication No.

AB–97–

9

• New Code for HIV–1 Viral Load Testing.

Program Memorandum

Medicaid State Agencies

(HCFA Pub. 17)

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

97–1 • Current Status of Medicaid Program Memorandums and Action Transmittals Issues Before Calendar Year 1997.

Program Memorandum

Regional Offices

(HCFA Pub. 54)

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

97–1 • Civil Money Penalty Collection Procedures.

State Operations Manual

Provider Certification

(HCFA Pub. 7)

(Superintendent of Documents No. HE 22.8/12)

281 • Interpretive Guidelines—Home Health Agencies.

282 • Model Letter to Provider.

Model Letter Notifying Provider of Results of Revisit.

Model Letter to Provider (Imposition of Remedies).

(Immediate Jeopardy Exists).

Informal Dispute Resolution.

Regional Office Manual

Standards and Certification

(HCFA Pub. 23–4)

(Superintendent of Documents No. HE 22.8/8–3)

63 • OPO Designation Procedures in Service Areas With Competing Applications.

Hospital Manual

(HCFA Pub. 10)

(Superintendent of Documents No. HE 22.8/2)

712 • Self-Administered Drugs and Biologicals.

Oral Cancer Drugs.

Self-Administered Antiemetic Drugs.

Self-Administered Drug Administered In An Emergency Situation.

Billing for Hospital Outpatient Partial Hospitalization Services.

Completion of Form HCFA–1450 For Inpatient And/Or Outpatient Billing.

713 • Review of Hospital Admissions of Patients Who Have Elected Hospice Care.

714 • Outpatient Therapeutic Services.

715 • Laboratory Test for Hemodialysis, Intermittent Peritoneal Dialysis, and Continuous Cycling Peritoneal Dialysis Included in Composite Rate.

Rural Health Clinic Manual and Federally

Qualified Health Centers Manual

(HCFA Pub. 27)

(Superintendent of Documents No. HE 22.8/19:985)

25 • Rural Health Clinics.

Federally Qualified Health Centers.

26 • Billing of Pneumococcal Pneumonia, Influenza Virus and Hepatitis B Vaccines By Rural Health Clinics and Federally Qualified

Health Centers.

Renal Dialysis Facility Manual

(Non-Hospital Operated)

(HCFA Pub. 29)

(Superintendent of Documents No. HE 22.8/13)

78 • Pneumoccal Pneumonia, Influenza Virus, and Hepatitis B Vaccines.

79 • Completion of Form HCFA–1450 by Independent Facilities for Home Dialysis Items and Services Billed Under the Composite

Rate (Method I).

80 • Epoetin.
62330 Federal Register / Vol. 62, No. 225 / Friday, November 21, 1997 / Notices

ADDENDUM III—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS—Continued

[April 1997 through June 1997]

Trans.

No. Manual/Subject/Publication No.

81 • Laboratory Test for Hemodialysis, Intermittent Peritoneal Dialysis, and Continuous Cycling Peritoneal Dialysis.

Coverage Issues Manual

(HCFA Pub. 6)

(Superintendent of Documents No. HE 22.8/14)

94 • Artificial Hearts and Related Devices.

95 • Electrostimulation in the Treatment of Wounds.

Intrapulmonary Percussive Ventilator.

96 • Breast Reconstruction Following Mastectomy Obsolete or Unreliable Diagnostic Test.

97 • Urinary Drainage Bags.

98 • –Electrostimulation in the Treatment of Wounds Intrapulmonary Percussive Ventilator.

99 • Laser Procedures.

Refractive Keratoplasty.

Magnetic Resonance Angiography.

100 • Electrostimulation in the Treatment of Wounds.

Intrapulmonary Percussive Ventilator.

101 • Laboratory Test-CRD Patients.

Provider Reimbursement Manual

Part 1—(HCFA Pub.15–1)

(Superintendent of Documents No. HE 22.8/4)

399 • Regional Medicare Swing-Bed SNF Rates.

Changing Cost Finding Methods.

Changing Bases for Allocating Costs Centers or Order in Which Cost Centers Are Allocated.

Provider Reimbursement Manual

Part 1—(HCFA Pub.15–1–27)

(Superintendent of Documents No. HE 22.8/4)

27 • Separately Billable ESRD Laboratory Services.

28 • Epoetin.

Provider Reimbursement Manual

Part II—Provider Cost Reporting Forms and Instructions (HCFA Pub. 15–II–AF)

(Superintendent of Documents No. HE 22.8/4)

5 • Electronic Reporting Specifications for Form HCFA 1728–94.

Medicare Provider Reimbursement Manual

Part II—Provider Cost Reporting Forms and Instructions (HCFA Pub. 15–11–AI)

(Superintendent of Documents No. HE 22. 8/4)

2 • Cost Center Coding.

Electronic Reporting Specifications for Form HCFA 2540–96.

Medicare/Medicaid

Sanction—Reinstatement Report

(HCFA Pub. 69)

97–5 • Report of Physicians/Practitioners, Providers and/or Other Health Care Suppliers Excluded/Reinstated—March 1997.

97–6 • Report of Physicians/Practitioners, Providers and/or Other Health Care Suppliers Excluded/Reinstated—April 1997.

ADDENDUM IV—REGULATION DOCUMENTS PUBLISHED IN THE FEDERAL REGISTER

Publication date FR Vol. 62 page CFR part(s) File code* Regulation title End of comment period

Effective

date

04/08/97 ............ 16894–16976 144, 146, 148 ... BPD–890–IFC Interim Rules for Health Insurance

Portability for Group Health Plans.

07/07/97 06/07/97

04/08/97 ............ 16985–17004 148 ................... BPD–882–IFC Individual Market Health Insurance

Reform: Portability From Group to

Individual Coverage; Federal Rules

for Access in the Individual Market;

State Alternative Mechanisms to

Federal Rules.

07/07/97 04/08/97
Federal Register / Vol. 62, No. 225 / Friday, November 21, 1997 / Notices 62331

ADDENDUM IV—REGULATION DOCUMENTS PUBLISHED IN THE FEDERAL REGISTER—Continued

Publication date FR Vol. 62 page CFR part(s) File code* Regulation title End of comment period

Effective

date

04/08/97 ............ 17004 ........................... BPD–882–CN

BPD–890–CN

Interim Rules for Health Insurance

Portability for Group Health Plans

and Individual Market Health Insurance Reform: Portability from Group

to Individual Coverage; and Federal

Rules for Access in the Individual

Market; State Alternative Mechanisms to Federal Rules; Correction.

.................... 04/08/97

04/17/97 ............ 18776–18777 ........................... ORD–098–N New and Pending Demonstration

Project Proposals Submitted Pursuant to Section 1115(a) of the Social

Security Act: February 1997.

.................... ....................

04/21/97 ............ 19326–19328 ........................... BPD–894–NC Medicare and Medicaid Programs;

Announcement of Additional Applications From Hospitals Requesting

Waivers for Organ Procurement

Service Area.

06/20/97 ....................

04/21/97 ............ 19328–19337 ........................... BPO–141–N Medicare and Medicaid Programs;

Quarterly Listing of Program

Issuances—Third Quarter 1996.

.................... ....................

04/28/97 ............ 22995 413 ................... BPD–808–P Medicare and Medicaid Programs;

Salary Equivalency Guidelines for

Physical Therapy, Respiratory Therapy, Speech Language Pathology,

and Occupational Therapy Services; Correction.

.................... ....................

04/29/97 ............ 23251–23253 ........................... HSQ–232–N Medicare Program; Initiative Involving

Facilities That Furnish Hemodialysis

Treatments.

.................... 10/28/96

04/29/97 ............ 23140 433 ................... MB–112–F Medicaid Program; Third Party Liability (TPL) Cost-Effectiveness Waivers; Correcting Amendment..................... 09/08/95

04/30/97 ............ 23368–23376 417 ................... OMC–025–FC Medicare Program; Establishment of

an Expedited Review Process for

Medicare Beneficiaries Enrolled in

Health Maintenance Organizations,

Competitive Medical Plans, and

Health Care Prepayment Plans.

06/30/97 06/30/97

05/05/97 ............ 24483–24491 ........................... BPD–816–N Medicare Program; Update of the

Reasonable Compensation Equivalent Limits for Services Furnished

by Physicians.

.................... 05/05/97

05/12/97 ............ 25844–25855 405, 417, 473 ... BPD–453–FC Medicare Programs; Medicare Appeals of Individual Claims.07/11/97 07/11/97

05/12/97 ............ 25855–25858 493 ................... HSQ–237–FC Medicare, Medicaid and CLIA Programs; Clinical Laboratory Requirements— Extension of Certain Effective Dates for Clinical Laboratory

Requirements Under CLIA.

07/11/97 05/12/97

05/12/97 ............ 25957 ........................... ORD–099–N New and Pending Demonstration

Project Proposals Submitted Pursuant to Section 1115(a) of the Social

Security Act: March 1997.

.................... ....................

05/12/97 ............ 25957–25964 ........................... BPO–148–N Medicare and Medicaid Programs;

Quarterly Listing of Program

Issuances; Fourth Quarter 1996.

.................... ....................

05/14/97 ............ 26545–26550 ........................... MB–103–NC Medicaid Program; Allocation of Enhanced Federal Matching Funds for

Increased Administrative Costs Resulting From Welfare Reform.

06/13/97 05/14/97

05/19/97 ............ 27262–27265 ........................... HSQ–242–N Approval of the Commission on Office

Laboratory Accreditation for

Immunohematology.

.................... 05/19/97–

11/1/97

05/19/97 ............ 27210 413 ................... BPD–788-CN Medicare Program; Electronic Cost

Reporting for Skilled Nursing Facilities and Home Health Agencies;

Correction.

.................... 05/19/97

05/30/97 ............ 29355–29356 ........................... OPL–015–N Medicare Program; June 16, 1997,

Meeting of the Practicing Physicians Advisory Council.

.................... ....................
62332 Federal Register / Vol. 62, No. 225 / Friday, November 21, 1997 / Notices

ADDENDUM IV—REGULATION DOCUMENTS PUBLISHED IN THE FEDERAL REGISTER—Continued

Publication date FR Vol. 62 page CFR part(s) File code* Regulation title End of comment period

Effective

date

06/02/97 ............ 29902–30037 412, 413, 489 ... BPD–878–P Medicare Program; Changes to the

Hospital Inpatient Prospective Payment Systems and Fiscal Year

1998 Rates.

08/01/97 ....................

06/04/97 ............ 30604–30605 ........................... ORD–100–N New and Pending Demonstration

Project Proposals Submitted Pursuant to Section 1115(a) of the Social

Security Act: April 1997.

.................... ....................

06/10/97 ............ 31669–31670 144, 146 ........... BPD–890–CN Interim Rules for Health Insurance

Portability for Group Health Plans;

Correction.

.................... ....................

06/17/97 ............ 32715–32733 410, 424 ........... BPD–813–P Medicare Program; Ambulance Services.08/18/97 ....................

06/18/97 ............ 33158–33305 400, 405, 410,

414.

BPD–884–P Medicare Program; Revisions to Payment Policies Under the Physician

Fee Schedule, Other Part B Payment Policies, and Establishment of

the Clinical Psychologist Fee

Schedule for Calendar Year 1998.

08/18/97 ....................

06/19/97 ............ 33459 ........................... MB–103–NC Medicaid Program; Allocation of Enhanced Federal Matching Funds for

Increased Administrative Costs Resulting From Welfare Reform; Correction.

.................... ....................

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. Also, 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. To

obtain more information about the

classes or categories, please refer to the

Federal Register notice published on

April 21, 1997 (62 FR 19328).

The following information presents

the device number, category (in this

case, A), and criterion code.

G960260 A1

G970007 A2

G970015 A2

G970018 A2

G970022 A2

G970068 A2

G970069 A2

G970076 A2

G970093 A2

G970121 A2

The following information presents

the device number, category (in this

case, B), and criterion code.

G960033 B4

G960209 B4

G960222 B2

G960233 B4

G960240 B5

G960261 B2

G970033 B4

G970043 B4

G970049 B3

G970060 B3

G970062 B1

G970063 B4

G970064 B2

G970065 B3

G970066 B4

G970067 B2

G970072 B2

G970077 B1

G970079 B2

G970080 B4

G970083 B4

G970085 B2

G970090 B4

G970091 B3

G970092 B2

G970098 B4

G970104 B2

G970105 B2

G970108 B1

G970109 B3

G970113 B4

G970115 B4

G970117 B4

[FR Doc. 97–30568 Filed 11–20–97; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4263–N–56]

Submission for OMB Review:

Comment Request

AGENCY: Office of Administration, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

has been submitted to the Office of

Management and Budget (OMB) for

review, as required by the Paperwork

Reduction Act. The Department is

soliciting public comments on the

subject proposal.

DATES: Comments due date: December

22, 1997.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments must be

received within thirty (30) days from the

date of this Notice. Comments should

refer to the proposal by name and/or

OMB approval number and should be

sent to: Joseph F. Lackey, Jr., OMB Desk

Officer, Office of Management and

Budget, Room 10235, New Executive

Office Building, Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Kay

F. Weaver, Reports Management Officer,

Department of Housing and Urban

Development, 451 7th Street,

Southwest, Washington, DC 20410,

telephone (202) 708–2374. This is not a

toll-free number. Copies of the proposed

forms and other available documents

submitted to OMB may be obtained

from Ms. Weaver.

SUPPLEMENTARY INFORMATION: The

Department has submitted the proposal

for the collection of information, as

described below, to OMB for review, as

required by the Paperwork Reduction

Act (44 U.S.C. Chapter 35).

The Notice lists the following

information: (1) the title of the