59358 Federal Register / Vol. 62, No. 212 / Monday, November 3, 1997 / Notices

ANNUAL BURDEN ESTIMATES—Continued

Instrument Number of

respondents

Number of responses per

respondent

Average burden

hours per

response

Total burden

hours

Federal Tax Offset contact ......................................................................... 54 1 2 minutes .......... 1.8 hours.

Update Spec ............................................................................................... 54 1 2 minutes .......... 1.8 hours.

Issuance of pre-offset notice ...................................................................... 54 1 2 minutes .......... 1.8 hours.

Contact point for OCSE Pre-offset notice .................................................. 30 1 1 minute ........... 0.9 hours.

Non-TANF Tax Refund Offset Information ................................................. 1,744 40,735 10 minutes ........ 6,789.2 hours.

Offset notice address/phone number change ............................................ 54 1 10 minutes ........ 9.0 hours.

Personal computer data ............................................................................. 54 1 5 minutes .......... 4.5 hours.

Notice of intention ....................................................................................... 25 1 2 minutes .......... 0.8 hours.

Estimated Total Annual Burden

Hours: 31,816.3.

Additional Information: Copies of the

proposed collection may be obtained by

writing to The Administration for

Children and Families, Office of

Information Services, Division of

Information Resource Management

Services, 370 L’Enfant Promenade, SW.,

Washington, DC 20447, Attn: ACF

Reports Clearance Officer. OMB Comment: OMB is required to

make a decision concerning the

collection of information between 30

and 60 days after publication of this

document in the Federal Register.

Therefore, a comment is best assured of

having its full effect if OMB receives it

within 30 days of publication. Written

comments and recommendations for the

proposed information collection should

be sent directly to the following: Office

of Management and Budget, Paperwork

Reduction Project, 725 17th Street, NW.,

Washington, DC 20503, Attn: Ms.

Wendy Taylor.

Dated: October 28, 1997.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 97–28965 Filed 10–31–97; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Current Topics in Immunohematologic

Testing; Public Workshop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

The Food and Drug Administration

(FDA) is announcing a public workshop

entitled ‘‘Current Topics in

Immunohematologic Testing.’’ The

topics to be discussed include

specificity and sensitivity of Anti-D

Blood Grouping Reagents; the

development of performance standards

for antiglobulin control cells and blood

bank saline; user interpretation of

labeling information; and the validation

and use of blood grouping

instrumentation.

Date and Time: The workshop will be

held on December 10, 1997, 8 a.m. to 5

p.m.

Location: The workshop will be held

at Natcher Auditorium, National

Institutes of Health, 9000 Rockville

Pike, Bldg. 45, Bethesda, MD.

Contact Person: Joseph Wilczek,

Center for Biologics Evaluation and

Research (HFM–350), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–827–

3514, FAX 301–827–2843.

SUPPLEMENTARY INFORMATION: The goals

of the workshop are specific to each

topic and include the following: (1)

Distinguish between those issues that

are medically important and those

issues that are primarily of scientific

interest with respect to Anti-D

specificity and sensitivity; (2) present

examples of significant problems

attributable to the variability seen

within two types of product,

antiglobulin control cells and blood

bank saline, due to the lack of

standards; (3) identify areas of

immunohematologic product labeling

which need to be modified to provide

the user with a better understanding of

its uses and limitations; and (4) discuss

user validation of complete systems as

well as partial or site-assembled systems

regarding blood grouping

instrumentation. The information

obtained from these presentations and

discussions will assist FDA in taking the

necessary steps for assuring the safety

and effectiveness of these medical

devices.

Registration and Requests for Oral

Presentations: Send or fax registration

information (including name, title, firm

name, address, telephone, and fax

number), written material, and requests

to make oral presentations by November

28, 1997, to Cody Bridges, 14504

Greenview Dr., suite 500, Laurel, MD

20708, 301–490–5500, FAX 301–490–

7260, e-mail CBRIDGES@lcgnet.com.

Registration at the site will be done on

a space available basis on the day of the

workshop beginning at 7:30 a.m. There

is no registration fee for the workshop.

If you need special accommodations

due to a disability, please contact Cody

Bridges at least 7 days in advance.

Transcripts: Transcripts of the

workshop may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, 5600 Fishers Lane, rm.

12A–16, Rockville, MD 20857,

approximately 15 working days after the

workshop at a cost of 10 cents per page.

Dated: October 24, 1997.

William K. Hubbard.

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–29049 Filed 10–31–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[BPO–150–N]

Medicare and Medicaid Programs;

Quarterly Listing of Program

Issuances—First 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 January, February, and

March 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
Federal Register / Vol. 62, No. 212 / Monday, November 3, 1997 / Notices 59359

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).

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

other information).

SUPPLEMENTARY INFORMATION:

I. Program Issuances

The Health Care Financing

Administration (HCFA) is responsible

for administering the Medicare and

Medicaid programs, which pay for

health care and related services for 38

million Medicare beneficiaries and 36

million Medicaid recipients.

Administration of these programs

involves (1) providing information to

Medicare beneficiaries and Medicaid

recipients, health care providers, and

the public, and (2) effective

communications with regional offices,

State governments, State Medicaid

Agencies, State Survey Agencies,

various providers of health care, fiscal

intermediaries and carriers that process

claims and pay bills, and others. To

implement the various statutes on

which the programs are based, we issue

regulations under the authority granted

the Secretary under sections 1102, 1871,

and 1902 and related provisions of the

Social Security Act (the Act) and also

issue various manuals, memoranda, and

statements necessary to administer the

programs efficiently.

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

that we publish in the Federal Register

at least every 3 months a list of all

Medicare manual instructions,

interpretive rules, and guidelines of

general applicability not issued as

regulations. We published our first

notice June 9, 1988 (53 FR 21730).

Although we are not mandated to do so

by statute, for the sake of completeness

of the listing of operational and policy

statements, we are continuing our

practice of including Medicare

substantive and interpretive regulations

(proposed and final) published during

the 3-month time frame. Since the

publication of our quarterly listing on

June 12, 1992 (57 FR 24797), we

decided to add Medicaid issuances to

our quarterly listings. Accordingly, we

list in this notice Medicaid issuances

and Medicaid substantive and

interpretive regulations published

during January through March 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. 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 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, ATTN:

New Orders, PO Box 371954,

Pittsburgh, PA 15250–7954,

Telephone (202) 512–1800, Fax

number (202) 512–2250 (for credit

card orders).

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
59360 Federal Register / Vol. 62, No. 212 / Monday, November 3, 1997 / Notices

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

Social Security Act.

• HCFA-related regulations.

• HCFA manuals and monthly

revisions.

• HCFA program memoranda.

The titles of the Compilation of the

Social Security Act 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 3—Claims Process (HCFA

Pub 13–3) transmittal entitled ‘‘Oral

Cancer Drugs,’’ use the Superintendent

of Documents No. HE 22.8/6 and the

HCFA transmittal number 1700.

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 Cathy

Johnson, Office of Communications and

Operations Support, Division of

Regulations and Issuances, 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: October 10, 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)

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.
Federal Register / Vol. 62, No. 212 / Monday, November 3, 1997 / Notices 59361

ADDENDUM III.—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS

[January 1997 through March 1997]

Trans.

No. Manual/Subject/Publication No.

Intermediary Manual Part 3—Claims Process (HCFA Pub. 13–3) (Superintendent of Documents No. HE 22.8/6)

1696 Æ Review of Form HCFA–1450 for Inpatient and Outpatient Bills.

Bill Review for Partial Hospitalization Services Provided in Community Mental Health Centers.

Pneumoccocal Pneumonia Influenza Virus and Hepatitis B Vaccines.

1697 Æ Laboratory Tests for Hemodialysis, Intermittent Peritoneal Dialysis and Continuous Cycling Peritoneal Dialysis Included in

Composite Rate.

Laboratory Tests for CAPD Covered Routinely and Separately Billable.

1698 Æ Review of Form HCFA–1450 for Inpatient and Outpatient Bills.

Review of Hospice Bills.

1699 Æ Medical—Subject to Waiver.

1700 Æ Oral Cancer Drugs.

Self-Administered Antiemetic Drugs

Mammography Quality Standards Act.

1701 Æ Hospital Outpatient Partial Hospitalization Services.

1702 Æ Billing for Durable Medical Equipment Orthotic/Prosthetic Devices and Surgical Dressings.

1703 Æ Applicability of Limitation on Liability to Items or Services Furnished by Providers of Services Payable Under Part A

When to Make Limitation on Liability Decisions.

1704 Æ Contractor Data Security and Confidentiality Requirements.

File Specifications, Records Specifications, and Data Element Definitions for EMC Bills.

Electronic Media Claims.

Requirements for Submission of EMC Data.

Claims Processing Timeliness.

1705 Æ Federal BL Program Address.

1706 Æ Ambulance Services.

1707 Æ Review of Form HCFA–1450 for Inpatient and Outpatient Bills.

EMC Flat File Record for ESRD Medical Documentation—Record Type (RT) 76.

Flat File Requirements for RT 76, ESRD Medical Documentation.

Provider Electronic Billing File and Record Format.

Alphabetic Listing of Data Elements.

Medical Review Attachment Data Definitions and Codes.

1708 Æ Routine Services and Appliances.

Carriers Manual Part 2—Program Administration (HCFA Pub. 14–2) (Superintendent of Documents No. HE 22.8/7–3)

13 Æ Claims Processing Timeliness.

Functional Standards for Claims Processing Operations.

Carriers Manual Part 3—Claims Process (HCFA Pub. 14–3) (Superintendent of Documents No. HE 22.8/7)

1555 Æ Reasonableness and Necessity.

1556 Æ Beneficiary Address Change.

1557 Æ Laboratory Tests.

Separately Billable Tests Furnished to Patients of Independent Dialysis Facilities.

1558 Æ Type of Service.

1559 Æ Reasonableness and Necessity.

1560 Æ Contractor Data Security and Confidentiality Requirements.

EMC Testing and Verification.

Data Sets and Formats for EMC and Electronic Remittance Advice.

Requirements for Processing EMC.

Technical Requirements.

Requirements for Processing EMC.

1561 Æ Federal Black Lung Program Address.

Charges by Relative or Member of Immediate Household.

Duplicate and/or Overlapping Bills With Discrepant Charges.

Evidence of Medical Necessity for Parenteral and Enteral Nutrition.

TPP Pays Primary Benefits When Not Required.

Federal Government’s Right to Sue and Collect Double Damages.

Documentation of Conformance.

When Medicare Secondary Benefits are Payable.

When Medicare Secondary Benefits are Not Payable.

Calculating Medicare Secondary Payments for Services Reimbursed on Reasonable Charge or Other Basis Under Part B.

Effect of Failure to File Proper Claim.

Effect of Primary Payments on Deductibles and Coinsurance.

Right of Physician or Supplier to Charge Beneficiary.

Charging Expenses Against Annual Limit on Incurred Expenses for Services of Independently Practicing Physical Therapist.

Nondiscrimination.

Medicare Secondary Payment for Managed Care Organization Copayments.

Individuals Receiving Delayed Compensation Payments Subject to FICA Taxes.

Referral to Internal Revenue Services.

Primary Payer is Bankrupt or Insolvent.
59362 Federal Register / Vol. 62, No. 212 / Monday, November 3, 1997 / Notices

ADDENDUM III.—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS—Continued

[January 1997 through March 1997]

Trans.

No. Manual/Subject/Publication No.

Determining Size of Employers.

Current Employment Status.

Limitation on Payment for Services to Individuals Entitled to Benefits on the Basis of ESRD Who are Covered by GHPs.

Prohibition Against Taking into Account, Medicare Eligibility or Entitlement and Benefit Differentiation During Coordination Period.

Determining Period During Which Medicare May Be Secondary Payer.

Dual Eligibility/Entitlement Situations.

Effect of ESRD MSP on Consolidated Omnibus Budget Reconciliation Act Continuation Coverage.

Medicare Secondary Payer Provision for Disabled Beneficiaries

Items and Services Furnished on or After August 10, 1993 and Before October 1, 1998.

Individuals Not Subject to MSP Provision.

The 100-or-More Employees Requirement.

Disabled Individuals Who Return to Work.

Dually-Entitled Individuals.

Items and Services Furnished on or After January 1, 1987 and Before August 10, 1993.

Prohibition Against Financial and Other Incentives.

Federal Government’s Right to Sue and Collect Double Damages.

Excise Tax Penalties for Contributors to Nonconforming Group Health Plans.

1563 Æ Paper Remittance Notice Requirements.

Program Memorandum Intermediaries (HCFA Pub. 60A) (Superintendent of Documents No. HE 22.8/6–5)

A–97–1 Æ Extension of Due Date for Filing Provider 2552–96 Cost Reports.

A–97–2 Æ Hospital Outpatient Procedures: Medicare Changes for Radiology and Other Diagnostic Coding Due to the 1997 HCPCS Update and New Dermatology HCPCS Codes.

A–97–3 Æ Cost Report Filing Requirements for Hospitals with Multiple Skilled Nursing Facilities.

Program Memorandum Intermediaries/Carriers (HCFA Pub. 60A/B) (Superintendent of Documents No. HE 22.8/6–5)

AB–96–

12

Æ Sterile Intravitreal Implant with Cytovene (Trade Name: Vitrasert).

AB–96–

13

Æ Revaccination of Beneficiaries Who Received Recalled Influenza Virus Vaccine.

AB–97–

1

Æ New Interest Rate Payable on Clean Claims Not Paid Timely.

AB–97–

2

Æ Calculation Methodology for Hematocrit Levels Used to Determine the Applicability of Payment for EPO Provided to ESRD Patients.

AB–97–

3

Æ Binding Contractor Hearing Officers to L/RMRP.

AB–97–

4

Æ Common Working File (CWF) Crossover Edits in Release 97.1.

AB–97–

5

Æ New Panels Approved by CPT.

State Operations Manual Provider Certification (HCFA Pub. 7) (Superintendent of Documents No. HE 22.8/12)

279 Æ Model Letter to Provider (Send with Form HCFA–2567) (Immediate Jeopardy Does Not Exist) Model Letter Notifying Provider

Acceptance of Allegation of Compliance.

Model Letter Notifying Provider of Results of Revisit.

Notice Requirements.

Timing of CMPs.

Procedures for Recommending Enforcement Remedies When Immediate Jeopardy Does Not Exist.

Response to Allegation of Compliance.

Basis for Imposing CMPs.

280 Æ Updates of Interpretive Guidelines and Survey Procedures for Hospitals.

Hospital Manual (HCFA Pub. 10) (Superintendent of Documents No. HE 22.8/2)

704 Æ Outpatient Therapeutic Services.

705 Æ Pneumococcal Pneumonia Influenza Virus and Hepatitis B Vaccines.

706 Æ Laboratory Tests for Hemodialysis, Intermittent Peritoneal Dialysis (IPD) and Continuous Cycling Peritoneal Dialysis (CCPD)

Included in Composite Rate.

Laboratory Tests for CAPD Covered Routinely and Separately Billable.

707 Æ Oral Cancer Drugs.

Self-Administered Antiemetic Drugs.

708 Æ Billing for Hospital Outpatient Partial Hospitalization Services.

709 Æ Billing for DME, Orthotic/Prosthetic Devices and Surgical Dressings.

710 Æ Ambulance Service Claims.

711 Æ Outpatient Therapeutic Services.
Federal Register / Vol. 62, No. 212 / Monday, November 3, 1997 / Notices 59363

ADDENDUM III.—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS—Continued

[January 1997 through March 1997]

Trans.

No. Manual/Subject/Publication No.

Home Health Agency Manual (HCFA Pub. 11) (Superintendent of Documents No. HE 22.8/5)

282 Æ Billing for Oral Cancer Drugs.

Self-Administered Antiemetic Drugs.

Medicare Renal Dialysis Facility Manual (Non-Hospital Operated) (HCFA Pub. 29) (Superintendent of Documents No. HE 22.8/13)

77 Æ Laboratory Tests for Hemodialysis, IPD and CCPD.

Medicare Outpatient Physical Therapy and Comprehensive Outpatient Rehabilitation Facility Manual (HCFA Pub. 9) (Superintendent of

Documents No. HE 22.8/9)

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

Medicare Coverage Issues Manual (HCFA Pub. 6) (Superintendent of Documents No. HE 22.8/14)

91 Æ Laboratory Tests—CRD Patients.

92 Æ Osteogenic Stimulation.

93 Æ Treatment of Motor Function Disorders with Electric Nerve Stimulation.

Transmyocardial Revascularization With Laser—Not Covered.

Intraocular Lenses (IOL).

Partial Ventriculectomy (Also known as Ventricular Reduction, Ventricular Remodeling or Heart Volume Reduction Surgery).

Cryosurgery of Prostate.

Vertebral Axial Decompression (VAX-D).

Infusion Pumps.

Medicare Provider Reimbursement Manual Part 1—(HCFA Pub.15–1) (Superintendent of Documents No. HE 22.8/4)

398 Æ Regional Medicare Swing-Bed SNF Rates.

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

Documents No. HE 22.8/4)

3 Æ Home Health Agency Complex Identification Data.

Adjustments to Expenses.

Cost Allocation—General Service Costs, and

Cost Allocation—Statistical Basis.

4 Æ Home Health Agency Cost Report.

Home Health Agency Complex Identification Data.

Cost Allocation—General Service Costs, and

Cost Allocation—Statistical Basis.

Cost Center Coding.

State Medicaid Manual—Part 3—Eligibility (HCFA Pub. 45–3) (Superintendent of Documents No. HE 22.8/10)

67 Æ Changes Due to Welfare Reform.

Changes in SSI Definition of Disability Due to Welfare Reform.

Citizenship and Alienage.

Aliens.

State Medicaid Manual—Part 4—Services (HCFA Pub. 45–4) (Superintendent of Documents No. HE 22.8/10)

70 Æ Home Respiratory Care for Ventilator-Dependent Individuals.

Home and Community-Based Services—Basis, Scope, and Purpose.

Description of Waiver Participants.

Definition of Services.

Safeguards—Assurances and Documentation.

Evaluations—Assurances and Documentation.

Cost Effectiveness—Assurances and Documentation.

Annual Report—Assurances and Documentations.

Independent Assessment of the Waiver.

Home and Community-Based Services—Model Waiver Request.

Home and Community-Based Services—Procedures to Request Renewal of Approved Waivers.

Home and Community-Based Services—Amendments.

State Medicaid Manual—Part 6 Payment for Services (HCFA Pub. 45–6) (Superintendent of Documents No. HE 22.8/10)

33 Æ Physician Services to Children Under 21.

Physician Services to Pregnant Women.

Medicare/Medicaid Sanction—Reinstatement Report (HCFA Pub. 69)

97–1 Æ Report of Physicians/Practitioners, Providers and/or Other Health Care Suppliers Excluded/Reinstated—December 1996.
59364 Federal Register / Vol. 62, No. 212 / Monday, November 3, 1997 / Notices

ADDENDUM III.—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS—Continued

[January 1997 through March 1997]

Trans.

No. Manual/Subject/Publication No.

97–2 Æ Cumulative Report of Physicians/Practitioners, Providers and/or Other Health Care Suppliers Sanctioned/Reinstated.

97–3 Æ Report of Physicians/Practitioners, Providers and/or Other Health Care Suppliers Excluded/Reinstated—January 1997.

97–4 Æ Report of Physicians/Practitioners, Providers and/or Other Health Care Suppliers Excluded/Reinstated—February 1997.

ADDENDUM IV.—REGULATION DOCUMENTS PUBLISHED IN THE FEDERAL REGISTER

Publication date FR vol. 61 page CFR

part(s) File code* Regulation title End of comment period

Effective

date

01/02/97 ............ 26–31 413 BPD–788–F Medicare Program; Electronic Cost Reporting

for Skilled Nursing Facilities and Home

Health Agencies.

.................... 02/01/97

01/13/97 ............ 1682–1685 435 MB–105–FC Medicaid Program; Redeterminations of Medicaid Eligibility Due to Welfare Reform.03/14/97 01/13/97

01/13/97 ............ 1768–1776 ................ BPD–882–N Notification Procedures for States Implementing ‘‘Alternative Mechanisms’’ in the Individual Health Insurance Market..................... ....................

01/16/97 ............ 2373–2374 ................ ORD–095–N New and Pending Demonstration Project Proposals Submitted Pursuant to Section

1115(a) of the Social Security Act: November 1996.

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

01/23/97 ............ 3563 ................ BPD–886–N Department of Health and Human Services,

Health Care Financing Administration; Department of Labor, Pension and Welfare

Benefits Administration; and Department of

the Treasury, Office of Tax Policy and Internal Revenue Service

(the Agencies ); Health Insurance Portability; Correction.

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

01/29/97 ............ 4305–4311 ................ ORD–089–N Medicare and Medicaid Programs; Small Business Innovation Research Grants for Fiscal

Year 1997.

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

01/31/97 ............ 4772–4776 ................ MB–104–N Medicaid Program; Preliminary Limitations on

Aggregate Payments to Disproportionate

Share Hospitals: Federal Fiscal Year 1997.

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

02/05/97 ............ 5433–5442 ................ HSQ–244–N CLIA Program; Clinical Laboratory Improvement Amendments of 1988—Denial of Exemption of Laboratories in the Commonwealth of Puerto Rico..................... 10/28/96

02/21/97 ............ 7945–7946 410

415

BPD–852–CN Medicare Program; Revisions to Payment Policies and Five-Year Review of and Adjustments to the Relative Value Units Under the

Physician Fee Schedule for Calendar Year

1997; Correction.

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

02/25/97 ............ 8451–8452 ................ ORD–096–N New and Pending Demonstration Project Proposals Submitted Pursuant to Section

1115(a) of the Social Security Act: December 1996.

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

03/06/97 ............ 10286 ................ OPL–014–N Medicare Program; March 24, 1997 Meeting of

the Practicing Physicians Advisory Council.

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

03/10/97 ............ 11035–11064 484 HSQ–238–P Medicare and Medicaid Programs; Use of the

OASIS as Part of the Conditions of Participation for Home Health Agencies.

06/09/97 ....................

03/10/97 ............ 11005–11035 484 BPD–819–P Medicare and Medicaid Programs; Conditions

of Participation for Home Health Agencies.

06/09/97 ....................

03/28/97 ............ 14851–14878 413 BPD–808–P Medicare and Medicaid Programs; Salary

Equivalency Guidelines for Physical Therapy, Respiratory Therapy, Speech Language Pathology, and Occupational Therapy

Services.

05/27/97 ....................

03/31/97 ............ 15187–15191 ................ ORD–097–N New and Pending Demonstration Project Proposals Submitted Pursuant to Section

1115(a) of the Social Security Act: January

1997 and Supplement to December 1996

Listing.

.................... ....................
Federal Register / Vol. 62, No. 212 / Monday, November 3, 1997 / Notices 59365

Addendum V—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.

G960213 A2

G960218 A1

G960258 A1

G960266 A1

G970004 A1

G970007 A1

G970015 A2

G970016 A2

G970018 A2

G970022 A2

G970035 A2

G970051 A2

G970053 A2

The following information presents

the device number category (in this

case, B), and criterion code.

G950115 B1

G956391 B2

G960193 B4

G960199 B2

G960208 B1

G960229 B1

G960230 B2

G960231 B3

G960234 B4

G960235 B3

G960241 B2

G960243 B2

G960245 B2

G960246 B1

G960247 B1

G960248 B4

G960249 B4

G960250 B3

G960252 B2

G960253 B4

G960254 B2

G960255 B2

G960256 B1

G960257 B3

G960259 B4

G960262 B3

G960263 B3

G960264 B3

G960267 B1

G970001 B3

G970002 B4

G970003 B3

G970005 B4

G970011 B2

G970012 B4

G970019 B3

G970023 B4

G970025 B3

G970026 B3

G970028 B3

G970029 B3

G970030 B1

G970031 B3

G970032 B3

G970033 B4

G970034 B4

G970037 B4

G970038 B4

G970039 B4

G970040 B3

G970041 B4

G970046 B1

G970047 B3

G970052 B1

G970054 B4

G970059 B3

[FR Doc. 97–28972 Filed 10–31–97; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[OACT–057–N]

RIN 0938–AI12

Medicare Program; Inpatient Hospital

Deductible and Hospital and Extended

Care Services Coinsurance Amounts

for 1998

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

SUMMARY: This notice announces the

inpatient hospital deductible and the

hospital and extended care services

coinsurance amounts for services

furnished in calendar year 1998 under

Medicare’s hospital insurance program

(Medicare Part A). The Medicare statute

specifies the formulae to be used to

determine these amounts.

The inpatient hospital deductible will

be $764. The daily coinsurance amounts

will be: (a) $191 for the 61st through

90th days of hospitalization in a benefit

period; (b) $382 for lifetime reserve

days; and (c) $95.50 for the 21st through

100th days of extended care services in

a skilled nursing facility in a benefit

period.

EFFECTIVE DATE: This notice is effective

on January 1, 1998.

FOR FURTHER INFORMATION CONTACT: John

Wandishin, (410) 786–6389. For casemix analysis only: Gregory J. Savord,

(410) 786–1521.

SUPPLEMENTARY INFORMATION:

I. Background

Section 1813 of the Social Security

Act (the Act) provides for an inpatient

hospital deductible to be subtracted

from the amount payable by Medicare

for inpatient hospital services furnished

to a beneficiary. It also provides for

certain coinsurance amounts to be

subtracted from the amounts payable by

Medicare for inpatient hospital and

extended care services. Section

1813(b)(2) of the Act requires us to

determine and publish between

September 1 and September 15 of each

year the amount of the inpatient

hospital deductible and the hospital and

extended care services coinsurance

amounts applicable for services

furnished in the following calendar

year.

II. Computing the Inpatient Hospital

Deductible for 1998

Section 1813(b) of the Act prescribes

the method for computing the amount of

the inpatient hospital deductible. The

inpatient hospital deductible is an

amount equal to the inpatient hospital

deductible for the preceding calendar

year, changed by our best estimate of the

payment-weighted average of the

applicable percentage increases (as

defined in section 1886(b)(3)(B) of the

Act). This estimate is used for updating

the payment rates to hospitals for

discharges in the fiscal year that begins

on October 1 of the same preceding

calendar year and adjusted to reflect real

case mix. The adjustment to reflect real

case mix is determined on the basis of

the most recent case mix data available.

The amount determined under this

formula is rounded to the nearest

multiple of $4 (or, if midway between

two multiples of $4, to the next higher

multiple of $4).

Section 4401(a) of the Balanced

Budget Act of 1997 (Public Law 105–33,

enacted on August 5, 1997) amended

section 1886(b)(3)(B)(i) of the Act by

making the percentage increase for

hospitals paid under the prospective

payment system 0 percent for fiscal year

1998. Section 4411(a) of the Balanced

Budget Act of 1997 similarly amended

section 1886(b)(3)(B)(ii) of the Act by

making the percentage increase for

hospitals excluded from the prospective

payment system 0 percent for fiscal year

1998. Therefore, our best estimate of the

payment-weighted average of the

increase in the payment rates for fiscal

year 1998 is 0 percent.

To develop the adjustment for real

case mix, an average case mix was first

calculated for each hospital that reflects

the relative costliness of that hospital’s