Federal Register / Vol. 63, No. 107 /Thursday, June 4, 1998 / Notices 30499

trade secret and/or confidential

commercial information (5 U.S.C.

552b(c)(4)) regarding pending issues and

applications.

FDA regrets that it was unable to

publish this notice 15 days prior to the

Neurological Devices Panel of the

Medical Devices Advisory Committee

meeting. Because the agency believes

there is some urgency to bring these

issues to public discussion and

qualified members of the Neurological

Devices Panel of the Medical Devices

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: May 27, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–14913 Filed 6–2–98; 9:28 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–9152–N]

Medicare and Medicaid Programs;

Quarterly Listing of Program

Issuances—Third 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 July, August, and

September 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

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 timeframe.

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).

Pamela 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 July through September 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

timeframe 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
30500 Federal Register / Vol. 63, No. 107 /Thursday, June 4, 1998 / Notices

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, ATTN:

New Orders, P.O. Box 371954,

Pittsburgh, PA 15250–7954,

Telephone (202) 512–1800, Fax

number (202) 512–2250 (for credit

card orders); or

National Technical Information Service,

Department of Commerce, 5825 Port

Royal Road, Springfield, VA 22161,

Telephone (703) 487–4630.

In addition, individual manual

transmittals and Program Memoranda

listed in this notice can be purchased

from NTIS. Interested parties should

identify the transmittal(s) they want.

GPO or NTIS can give complete details

on how to obtain the publications they

sell. Additionally, all manuals are

available at the following Internet

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

progman.htm.

B. Regulations and Notices

Regulations and notices are published

in the daily Federal Register. Interested

individuals may purchase individual

copies or subscribe to the Federal

Register by contacting the GPO at the

address given above. When ordering

individual copies, it is necessary to cite

either the date of publication or the

volume number and page number.

The Federal Register is also available

on 24x microfiche and as an online

database through GPO Access. The

online database is updated by 6 a.m.

each day the Federal Register is

published. The database includes both

text and graphics from Volume 59,

Number 1 (January 2, 1994) forward.

Free public access is available on a

Wide Area Information Server (WAIS)

through the Internet and via

asynchronous dial-in. Internet users can

access the database by using the World

Wide Web; the Superintendent of

Documents home page address is http:/

/www.access.gpo.gov/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 Home Health

Agency Manual, (HCFA Pub. 11)

transmittal entitled ‘‘Billing for Durable

Medical Equipment, Orthotic/Prosthetic

Devices,’’ use the Superintendent of

Documents No. HE 22.8/5 and the

HCFA transmittal number 283.

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 Pamela

Gulliver, Office of Communications and
Federal Register / Vol. 63, No. 107 /Thursday, June 4, 1998 / Notices 30501

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: May 5, 1998.

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.

December 18, 1996 (61 FR 66676)

April 21, 1997 (62 FR 19328)

May 12, 1997 (62 FR 25957)

November 3, 1997 (62 FR 59358)

November 21, 1997 (62 FR 62325)

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.

Addendum III—Medicare and Medicaid Manual Instructions July 1997 Through September 1997

Trans. Manual/Subject/Publication No,

Intermediary Manual

Part 1—Fiscal Administration

(HCFA Pub. 13–1)

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

128 ............... • Coordination of Medicare and Complementary Insurance Programs.

Coordination of Medicare With the Federal Grants in Aid Program (Medicaid).

Intermediary Manual

Part 3—Claims Process

(HCFA Pub. 13–3)

(Superintendent of Documents No. HE 22.8/6)

1715 ............. • Self-Administered Drug Administered In An Emergency Situation.

1716 ............. • Mammography Screening.

1717 ............. • HCPCS for Hospital Outpatient Radiology Services and Other Diagnostic Procedures.

1718 ............. • Billing for Durable Medical Equipment, Orthotic/Prosthetic Devices and Surgical Dressings.

1719 ............. • CFA Common Procedure Coding System.

1720 ............. • Completing Quarterly Report on Provider Enrollment.

1721 ............. • Laboratory Tests for Hemodialysis, Intermittent Peritoneal Dialysis, Continuous Cycling Peritoneal Dialysis and Hemofiltration.

Laboratory Tests.

1722 ............. • HCPCS Codes for Diagnostic Services and Medical Services (Correction to Transmittal Number 1719, dated July 1997).

1723 ............. • Claims Processing Timeliness.

1724 ............. • HCPCS Codes for Diagnostic Services and Medical Services—Correction to Transmittal Number 1722, Dated August 1997.

1725 ............. • Mammography Screening.

Focused Medical Review.

Focused Medical Review Activity Report.

1726 ............. • Review of Form HCFA–1450 for Inpatient and Outpatient Bills.

Provider Electronic Billing File and Record Formats.

Alphabetic Listing of Data Elements.

Intermediary Manual.

Part 4—Audit Procedures

(HCFA Pub. 13–4)

(Superintendent of Documents No. HE 22.8/6–4)

33 ................. • Home Office Uniform Desk Review.

Carriers Manual

Part 1—Fiscal Administration (HCFA Pub. 14–1)

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

122 ............... • Coordination of Medicare and Complementary Insurance Programs.

• Coordination of Medicare With the Federal Grants in Aid Program (Medicaid).

Carriers Manual

Part 2—Claims Process (HCFA Pub. 14–2)

(Superintendent of Documents No. HE 22.8/7–3)

136 ............... • Functional Standards for Claims Processing Operations.
30502 Federal Register / Vol. 63, No. 107 /Thursday, June 4, 1998 / Notices

Trans. Manual/Subject/Publication No,

Carriers Manual

Part 3—Claims Process

(HCFA Pub. 14–3)

(Superintendent of Documents No. HE 22.8/7)

1573 ............. • Evidence of Medical Necessity for Durable Medical Equipment.

General Claims Processing Requirements.

Billing Requirements.

Simplified Roster Bills.

Health Insurance Maintenance Organization Processing Requirements.

Speciality Code/Place of Service Processing Requirements.

Suppression of EOMBs.

Billing Requirements for Global Surgeries.

Claims Review for Global Surgeries.

Payment for Return Trips to the Operating Room for Treatment of Complications.

EOMB and Remittance Messages.

Payment for Eyeglasses, Contact Lenses, and Related Services.

Interpretation of Diagnostic Tests.

1574 ............. • Identifying a Screening Mammography Claim.

1575 ............. • Claims Processing Terminology.

Handling Incomplete or Invalid Claims.

Conditional Data Element Requirements.

Data Element Requirements Matrix.

Data Element Requirements.

Incomplete or Invalid Claims.

1576 ............. • Exception to § 7560 A and B When Physician, Other Practitioner, or Supplier Is Excluded From Participation in Medicare Program.

Authority to Exclude Practitioners, Providers, and Suppliers of Services.

1577 ............. • Evidence of Medicaid Necessity for Durable Medical Equipment (Correction to Transmittal Number 1573, dated July 1997).

1578 ............. • Assistant at Surgery Services.

Purchased Diagnostic Tests.

Inpatient Dialysis On Same Date As Evaluation and Management.

Consultations.

Threshold Times For Codes 99354 and 99355.

1579 ............. • Services Eligible for HPSA Bonus Payments.

Remittance Messages.

1580 ............. • Doctor of Medicine and Osteopathy.

Carriers Manual

Part 4—Professional Relations

(HCFA Pub. 14–4)

(Superintendent of Documents No. HE 22.8/7–4)

14 ................. • Patient and Insured Information.

Provider of Service or Supplier Information.

Place of Service Codes and Definitions.

Program Memorandum

Intermediaries (HCFA Pub. 60A)

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

A–97–5 ......... • Application of Medicare Reasonable Cost Reimbursement Principles to Rural Health Clinics.

A–97–6 ......... • Extension of Due Date for Filing Form HCFA–2540–96 and Form HCFA–1728–94 Cost Reports.

A–97–7 ......... • Home Health Agency Requests to Intermediaries to Change Cost Center Allocation Sequence or Statistical Allocation Basis.

A–97–8 ......... • Instructions to Implement the New Medicare Summary Notice.

A–97–9 ......... • Hospital Outpatient Procedures: Medicare Changes Due to 1997 HCPCS Update—New Dermatology Codes (Clarification).

A–97–10 ....... • Change in Hospice Payment Rates.

A–97–11 ....... • Hospice Provisions Enacted by the Balanced Budget Act of 1997.

A–97–12 ....... • Medicare Home Health Benefit—The Balanced Budget Act of 1997 Clarification of Part-Time or Intermittent Skilled Nursing

Care.

A–97–13 ....... • FY 1998 Prospective Payment System, TEFRA Hospital and Other Bill Processing Changes.

A–97–14 ....... • Hospital Outpatient Procedures: Billing for Contrast Material (Clarification).

Program Memorandum

Carriers

(HCFA Pub. 60B)

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

B–97–2 ......... • Changes to Correct Coding Edits, Version 4.0.

B–97–3 ......... • Instructions for CLIA Compliance for Part B Laboratory Claims Submitted to Carriers.

B–97–4 ......... • Instructions for CLIA Compliance for Part B Laboratory Claims Submitted to Carriers— Correction to Transmittal Number B–

97–3, dated September 1997.

B–97–5 ......... • Update of Rates and Wage Index for Ambulatory Surgical Center Payments Effective October 1, 1997.
Federal Register / Vol. 63, No. 107 /Thursday, June 4, 1998 / Notices 30503

Trans. Manual/Subject/Publication No,

Program Memorandum

Intermediaries/Carriers

(HCFA Pub. 60A/B)

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

AB–97–10 ..... • Claims for Separately Billable End Stage Renal Disease Laboratory Services Performed by Certified Independent Dialysis Facilities.

AB–97–11 ..... • Counting of Non-Medicare Home Health Visits and the Reporting of the Associated Costs in Determining the Average Cost

Per Visit for Home Health Services.

AB–97–12 ..... • New Implementation Date for Hematocrit Levels for Erythropoietin.

AB–97–13 ..... • Extension of the Limitation on Payment for Services to Individuals Entitled to Benefits on the Basis of End Stage Renal Disease Who are Covered by Group Health Plans.

AB–97–14 ..... • Extension of the Limitation on Payment for Services to Individuals Entitled to Benefits on the Basis of End Stage Renal Disease Who are Covered by Group Health Plans (GHP)— Correction to Program Memorandum Number AB–97–13, dated September 1997.

AB–97–15 ..... • Update to the Hospice Wage Index.

AB–97–16 ..... • Balanced Budget Act of 1997, P.L. 105–33 (H.R. 2015)—Home Health Payment Provisions.

AB–97–17 ..... • New Panels Approved by Common Procedural Terminology—Clarification of Program Memorandum AB–97–5.

AB–97–18 ..... • Balanced Budget Act of 1997, P.L. 105–33 (H.R.)-Home Health Payment Provisions.

State Operations Manual

Provider Certification

(HCFA Pub. 7)

(Superintendent of Documents No. HE 22.8/12)

283 ............... • Interpretive Guidelines and Survey Procedures.

Peer Review Organization Manual

(HCFA Pub. 19)

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

64 ................. • Opportunity to Discuss.

Authority.

Scope of Review.

Complaints That Do Not Meet Statutory Requirements.

Referrals.

Review Process.

Hospital Manual

(HCFA Pub. 10)

(Superintendent of Documents No. HE 22.8/2)

716 ............... • Self-Administered Drug Administered In An Emergency Situation.

717 ............... • Billing for Mammography Screening.

718 ............... • HCPCS for Hospital Outpatient Radiology Services and Other Diagnostic Procedures.

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

720 ............... • HCFA Common Procedure Coding System.

721 ............... • HCPCS Codes for Diagnostic Services and Medical Services.

722 ............... • Billing for Mammography Screening.

Home Health Agency Manual

(HCFA Pub. 11)

(Superintendent of Documents No. HE 22.8/5)

283 ............... • Billing for Durable Medical Equipment, Orthotic/Prosthetic Devices.

Skilled Nursing Facility Manual

(HCFA Pub. 12)

(Superintendent of Documents No. HE 22.8/3)

348 ............... • Billing for Mammography Screening.

349 ............... • Billing for Durable Medical Equipment (DME), Orthotic/Prosthetic Devices, and Surgical Dressings.

350 ............... • Billing for Mammography Screening.

Outpatient Physical Therapy and Comprehensive Outpatient Rehabilitation Facility Manual

(HCFA Pub. 9)

(Superintendent of Documents No. HE 22.8/9)

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

Coverage Issues Manual

(HCFA Pub. 6)

(Superintendent of Documents No. HE 22.8/18)

102 ............... • Hyperbaric Oxygen Therapy
30504 Federal Register / Vol. 63, No. 107 /Thursday, June 4, 1998 / Notices

Trans. Manual/Subject/Publication No,

Lung Volume Reduction Surgery (Reduction Pneumoplasty, Also Called Lung Shaving or Lung Contouring) Unilateral or Bilateral

by Open or Thoracoscopic Approach for Treatment of Emphysema or Chronic Obstructive Pulmonary Disease.

Provider Reimbursement Manual—Part 1

(HCFA Pub. 15–1)

(Superintendent of Documents No. 22.8/4)

400 ............... • Provider Requests Regarding Applicability of Cost Limits.

Request for Exemption From Skilled Nursing Facility Cost Limits.

Provider Reimbursement Manual—Part I

Chapter 27—Reimbursement for ESRD and Transplant Services

(HCFA Pub. 15–1–27)

(Superintendent of Documents No. 22.8/4)

29 ................. • Allowable Compensation for Physician Owners and Medical Directors

Allowable Compensation for Owners, Administrators, and Assistant Administrators.

Submission of Documentation.

Provider Reimbursement Manual—Part II

Provider Cost Reporting Forms and Instructions

(HCFA Pub. 15–II–A)

(Superintendent of Documents No. 22.8/4)

19 ................. • Electronic Submission of Cost Reports.

Electronic Submission of Hospital Cost Reports.

Electronic Submission of SNF and HHA Cost Reports.

Provider Reimbursement Manual—Part II

Provider Cost Reporting Forms and Instructions

(HCFA Pub. 15–II–A)

(Superintendent of Documents No. 22.8/4)

3 ................... • Hospital and Hospital Health Care Complex Cost Report, Form HCFA–2552–96.

State Medicaid Manual—Part 2

State Organization and General Administration

(HCFA Pub. 45–2)

(Superintendent of Documents No. HE22.8/10)

89 ................. • Statistical Report on Medical Care: Eligibles, Recipients, Payments, and Services (Form HCFA–2082).

Requirements for State Participation in the Medicaid Statistical Information System.

State Medicaid Manual—Part 3

Eligibility

(HCFA Pub. 45–3)

(Superintendent of Documents No. HE22.8/10)

68 ................. • Retroactive Medicaid Coverage.

State Medicaid Manual—Part 6

Payment for Services

(HCFA Pub. 45–6)

(Superintendent of Documents No. HE22.8/10)

34 ................. • Ingredient Prices Used by States to Establish Upper Limits for Prescription Drugs.

Rural Health Clinic Manual and Federally

Qualified Health Centers Manual

(HCFA Pub. 27)

(Superintendent of Documents No. HE22.8/19:985)

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

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

Program Memorandum

State Survey Agencies

(HCFA Pub. 65)

97–1 ............. • Policy Clarification: Home Health Agency Parent, Branch, and Subunit Criteria.

Medicare/Medicaid

Sanction—Reinstatement Report

(HCFA Pub. 69)

97–7 ............. • Report of Physicians/Practitioners, Providers and/or Other Health Care Suppliers Excluded/Reinstated—May 1997.
Federal Register / Vol. 63, No. 107 /Thursday, June 4, 1998 / Notices 30505

Trans. Manual/Subject/Publication No,

97–8 ............. • Report of Physicians/Practitioners, Providers and/or Other Health Care Suppliers Excluded/Reinstated—June 1997.

97–9 ............. • Report of Physicians/Practitioners, Providers and/or Other Health Care Suppliers Excluded/Reinstated—July 1997.

97–10 ........... • Report of Physicians/Practitioners, Providers and/or Other Health Care Suppliers Excluded/Reinstated—August 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

07/01/97 ....... 35513–

35516

.................... HSQ–243–N ..... Medicare, Medicaid, and CLIA Programs; Clinical

Laboratory Improvement Amendments of 1988

Continuance of Exemption of Laboratories Licensed by the State of Washington.

.................... 07/01/97

07/01/97 ....... 35608–

35634

.................... BPD–889–NC ... Medicare Program; Schedule of Limits on Home

Health Agency Costs Per Visit for Cost Reporting Periods Beginning on or After July 1, 1997.

09/02/97 07/01/97

07/02/97 ....... 35824–

35826

.................... HSQ–207–NC .. Medicare Program; Description of the Health Care

Financing Administration’s Evaluation Methodology for the Peer Review Organization 5th

Scope of Work Contracts.

09/02/97 07/02/97

07/16/97 ....... 38100–

38107

.................... BPD–845–PN ... Medicare Program; Special Payment Limits for

Home Oxygen.

09/15/97 07/16/97

07/17/97 ....... 38314–

38315

.................... ORD–101–N ..... New and Pending Demonstration Project Proposals Submitted Pursuant to Section 1115(a) of

the Social Security Act: May 1997.

.................... 07/17/97

07/29/97 ....... 40568 .................... BPD–889–NC ... Medicare Program; Schedule of Limits on Home

Health Agency Costs Per Visit for Cost Reporting Periods Beginning on or After July 1, 1997;

CORRECTION.

.................... 07/01/97

08/08/97 ....... 42860–

42883

418 BPD–820–F ...... Medicare Program; Hospice Wage Index ............... .................... 10/01/97

08/14/97 ....... 43541–

43542

.................... ORD–102–N ..... New and Pending Demonstration Project Proposals Submitted Pursuant to Section 1115(a) of

the Social Security Act: June 1997.

.................... 08/14/97

08/15/97 ....... 43657–

43674

412 413

414

BPD–763–F ...... Medicare Program; End-Stage Renal Disease

(ESRD) Payment Exception Requests and

Organ Procurement Costs.

.................... 08/15/97

08/18/97 ....... 43962–

43963

400 405

410 414

BPD–884–CN ... 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; CORRECTION.

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

08/18/97 ....... 43931–

43937

431 442

488 489

498

HSQ–139–F ..... Medicare and Medicaid Programs; Effective Dates

of Provider Agreements and Supplier Approvals.

.................... 09/17/97

08/20/97 ....... 44221 488 HSQ–156–CN .. Medicare and Medicaid Programs; Survey, Certification and Enforcement of Skilled Nursing Facilities and Nursing Facilities..................... 07/01/95

08/29/97 ....... 45815–

45821

.................... HSQ–219–GNC CLIA Program; Fee Schedule Revision .................. 10/28/97 01/01/98

08/29/97 ....... 45823 .................... OPL–016–N ...... Medicare Program; September 22, 1997, Meeting

of the Practicing Physician Ad visory Council.

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

08/29/97 ....... 45966–

46140

400 409

410 411

412 413

424 440

485 488

489 498

BPD–878–FC ... Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal

Year 1998 Rates.

10/28/97 10/01/97

09/04/97 ....... 46698–

46707

416 BPD–831–P ...... Medicare Program; Adjustment in Payment

Amounts for New Technology Intraocular

Lenses.

11/03/97 09/04/97

09/08/97 ....... 47237 416 BPD–878–FC ... Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal

Year 1998 Rates; CORRECTION.

09/11/97 ....... 47896–

47903

440 MB–071–F ........ Medicaid Program; Coverage of Personal Care

Services.

.................... 11/10/97

09/12/97 ....... 48098–

48105

.................... MB–115–N ....... State Children’s Health Insurance Program; Reserved Allotments to States for Fiscal Year

1998; Enhanced Federal Medical Assistance

Percentages.

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

09/15/97 ....... 48292–

48297

.................... MB–110–N ....... Medicaid Program; Final Limitations on Aggregate

Payments to Disproportionate Share Hospitals:

Federal Fiscal Year 1997.

.................... ....................
30506 Federal Register / Vol. 63, No. 107 /Thursday, June 4, 1998 / 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

09/17/97 ....... 48872–

48873

.................... BPD–898–NC ... Medicare and Medicaid Programs; Announcement

of Additional Applications From Hospitals Requesting Waivers for Organ Procurement Service Area.

11/17/97 ....................

09/18/97 ....... 49049 400 409

410 411

412 413

424 440

485 488

489 498

BPD–878–FC ... Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal

Year 1998 Rates; CORRECTION.

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

09/23/97 ....... 49649–

49654

.................... OMC–029–N .... Medicare Program; Solvency Standards for Provider-Sponsored Organizations; Intent To Form

Negotiated Rulemaking Committee.

10/08/97 ....................

09/23/97 ....... 49726 440 MB–071–F ........ Medicaid Program; Coverage of Personal Care

Services; CORRECTION.

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

09/24/97 ....... 49937–

49938

473 BPD–453–CN ... Medicare Program; Medicare Appeals of Individual

Claims; CORRECTION.

.................... 06/11/97

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.

G960082 A1

G970008 A4

G970044 A2

G970058 A2

G970069 A2

G970073 A2

G970088 A2

G970118 A2

G970121 A2

G970128 A1

G970131 A1

G970136 A2

G970147 A1

G970151 A2

G970169 A2

G970176 A2

The following information presents

the device number, category (in this

case, B), and criterion code.

G910187 B1

G960161 B4

G970014 B2

G970015 B4

G970024 B4

G970045 B4

G970081 B4

G970094 B3

G970096 B1

G970112 B2

G970116 B1

G970117 B4

G970122 B4

G970123 B4

G970129 B2

G970132 B3

G970133 B3

G970134 B4

G970135 B4

G970137 B4

G970138 B4

G970140 B1

G970141 B2

G970142 B1

G970149 B3

G970150 B1

G970157 B4

G970161 B4

G970168 B1

G970178 B2

G970179 B2

G970180 B4

G970183 B1

G970189 B4

G970191 B1

G970193 B2

G970194 B2

[FR Doc. 98–14834 Filed 6–3–98; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Human Genome Research

Institute; Notice of Closed Meetings

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

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

is hereby given of the following

meetings:

Name of Committee: National Human

Genome Research Institute Initial Review

Group, Ethical, Legal, and Social

Implications Subcommittee.

Agenda/Purpose: To review and evaluate

grant applications and/or contract proposals.

Date: June 4, 1998.

Time: 9:00 am–5:00 pm.

Place: Holiday Inn Hotel, Bethesda,

Maryland.

This notice is being published less than

fifteen days prior to the meeting due to the

urgent need to meet timing limitations

imposed by the review and funding cycle.

Name of Committee: National Human

Genome Research Institute, Special Emphasis

Panel 01.

Agenda/Purpose: To review and evaluate

grant applications and/or contract proposals.

Date: June 30, 1998.

Time: 8:30–12 Noon.

Place: Holiday Inn Hotel, Bethesda,

Maryland.

Name of Committee: National Human

Genome Research Institute Initial Review

Group, Genome Research Review

Subcommittee.

Agenda/Purpose: To review and evaluate

grant applications and/or contract proposals.

Date: June 20, 1998.

Time: 1:00–5:00 pm.

Place: Holiday Inn Hotel, Bethesda,

Maryland.

Name of Committee: National Human

Genome Research Institute, Special Emphasis

Panel 02.

Agenda/Purpose: To review and evaluate

grant applications and/or contract proposals.

Date: June 30, 1998.

Time: 8:30 am–5:00 pm.

Place: Holiday Inn Hotel, Bethesda,

Maryland.

Name of Committee: National Human

Genome Research Institute, Special Emphasis

Panel 03.

Agenda/Purpose: To review and evaluate

grant applications and/or contract proposals.

Date: July 1–2, 1998.

Time: 8:30 am–5:00 pm.

Place: Holiday Inn Hotel, Bethesda,

Maryland.