17538 Federal Register / Vol. 60, No. 66 / Thursday, April 6, 1995 / Notices

conditions and thereby have the potential to

affect product safety, purity, or potency:

(a) Use of a previously unapproved

manufacturing area or facility;

(b) Change in air quality, water quality,

material, or personnel flow for licensed

product manufacturing areas.

(c) Change from single product

manufacturing to multiple product

manufacturing using same equipment

and/or personnel.

(d) Renovation to physical structure that

alters product, material, and/or

personnel flow.

xix. Addition to or replacement of an FDAapproved manufacturing step performed

under contract to a second facility.

D. Categorization of Proposed Changes

Before implementing a change which is not

identified above or does not clearly fit into

one of the defined categories, manufacturers

should discuss the proposed change with

CBER. If guidance is not sought, the change

should be reported in the form of a Category

III supplement, subject to CBER approval

prior to implementation.

Requests for information regarding

categorization of proposed changes not

included in the above categories may be

addressed to the Director of the appropriate

applications Division within the Office with

assigned product, or establishment,

responsibility at the Center for Biologics

Evaluation and Research (HFM–99), Food

and Drug Administration, 1401 Rockville

Pike, suite 200N, Rockville, MD 20852–1448.

E. Information Requested for Category I

Periodic Reports

FDA requests that manufacturers submit

the following information for each Category

I change in the order shown: (1) Name of the

manufacturer; (2) the establishment license

number; (3) the report dates (time period

covered by the report); (4) the product(s)

affected (list each one); (5) the change

implemented, including: (a) A brief

description and reason for the change and/or

modification, (b) the establishment location

involved, (c) the date the change was

implemented, and (d) a cross-reference to the

Approved Validation Protocol or Standard

Operating Procedure, if applicable; and (6)

the signature of the Responsible Head and

the date signed.

Dated: March 31, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–8382 Filed 4–5–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 93F–0201]

Asahi Denka Kogyo K. K.; Withdrawal

of Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

withdrawal, without prejudice to a

future filing, of a food additive petition

(FAP 3B4378) proposing that the food

additive regulations be amended to

provide for the safe use of sodium 2,2′-

methylenebis(4,6-di-tert-butylphenyl)

phosphate as a clarifying agent in

polypropylene articles intended for

contact with food to include the use at

temperatures up to and including retort

conditions.

FOR FURTHER INFORMATION CONTACT:

Helen R. Thorsheim, Center for Food

Safety and Applied Nutrition (HFS–

216), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3092.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

July 29, 1993 (58 FR 40656), FDA

announced that a food additive petition

(FAP 3B4378) had been filed by Asahi

Denka Kogyo K. K., c/o Japan Technical

Information Center, Inc., 1002

Pennsylvania Ave. SE., Washington, DC

20003. The petition proposed to amend

the food additive regulations in

§ 178.3295 Clarifying agents for

polymers (21 CFR 178.3295) to provide

for the safe use of sodium 2,2′-

methylenebis(4,6-di-tert-butylphenyl)

phosphate as a clarifying agent in

polypropylene articles

intended for contact with food to

include the use at temperatures up to

and including retort conditions. Asahi

Denka Kogyo K. K. has now withdrawn

the petition without prejudice to a

future filing (21 CFR 171.7)

Dated: March 22, 1995.

Eugene C. Coleman,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 95–8515 Filed 4–5–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 94F–0121]

BASF Corp.; Withdrawal of Food

Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

withdrawal, without prejudice to a

future filing, of a food additive petition

(FAP 3B4384) proposing that the food

additive regulations be amended to

provide for the safe use of

hydroxypropyl acrylate and butanediol

diacrylate as monomers in the

production of acrylic polymers intended

for use in food packaging adhesives.

FOR FURTHER INFORMATION CONTACT:

Diane E. Robertson, Center for Food

Safety and Applied Nutrition (HFS–

216), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3089.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

April 25, 1994 (59 FR 19730), FDA

announced that a food additive petition

(FAP 3B4384) had been filed by BASF

Corp., 9401 Arrow Point Blvd., suite

200, Charlotte, NC 28273. The petition

proposed to amend the food additive

regulations in § 175.105 Adhesives (21

CFR 175.105) to provide for the safe use

of hydroxypropyl acrylate and

butanediol diacrylate as monomers in

the production of acrylic polymers

intended for use in food packaging

adhesives. BASF Corp. has now

withdrawn the petition without

prejudice to a future filing (21 CFR

171.7).

Dated: March 22, 1995.

Eugene C. Coleman,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 95–8516 Filed 4–5–95; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[BPO–130–N]

Medicare and Medicaid Programs;

Quarterly Listing of Program

Issuances and Coverage Decisions—

Fourth Quarter 1994

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

SUMMARY: This notice lists HCFA

manual instructions, substantive and

interpretive regulations and other

Federal Register notices, and statements

of policy that were published during

October, November, and December of

1994 that relate to the Medicare and

Medicaid programs. 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.

We are also providing the content of

revisions to the Medicare Coverage

Issues Manual published between

October 1 and December 31, 1994. On

August 21, 1989, we published the

content of the Manual (54 FR 34555)

and indicated that we will publish
Federal Register / Vol. 60, No. 66 / Thursday, April 6, 1995 / Notices 17539

quarterly any updates. Adding to this

listing the complete text of the changes

to the Medicare Coverage Issues Manual

allows us to fulfill this requirement in

a manner that facilitates identification

of coverage and other changes in our

manuals.

FOR FURTHER INFORMATION CONTACT:

Margaret Cotton, (410) 966–5255 (For

Medicare instruction information); Pat

Prete, (410) 966–3246 (For Medicaid

instruction information); Michael

Robinson, (410) 966–5633 (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 who process

claims and pay bills, and others. To

implement the various statutes on

which the programs are based, we issue

regulations under authority granted the

Secretary under sections 1102, 1871,

and 1902 and related provisions of the

Social Security Act (the Act) and also

issue various manuals, memoranda, and

statements necessary to administer the

programs efficiently.

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

that we publish in the Federal Register

at least every 3 months a list of all

Medicare manual instructions,

interpretive rules, statements of policy,

and guidelines of general applicability

not issued as regulations. We published

our first notice June 9, 1988 (53 FR

21730). Although we are not mandated

to do so by statute, for the sake of

completeness of the listing of

operational and policy statements, we

are continuing our practice of including

Medicare substantive and interpretive

regulations (proposed and final)

published during the 3-month

timeframe. 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 are listing in this

notice Medicaid issuances and

Medicaid substantive and interpretive

regulations published from October 1

through December 31, 1994.

II. Medicare Coverage Issues

We receive numerous inquiries from

the general public about whether

specific items or services are covered

under Medicare. Providers, carriers, and

intermediaries have copies of the

Medicare Coverage Issues Manual,

which identifies those medical items,

services, technologies, or treatment

procedures that can be paid for under

Medicare. On August 21, 1989, we

published a notice in the Federal

Register (54 FR 34555) that contained

all the Medicare coverage decisions

issued in that manual.

In that notice, we indicated that

revisions to the Coverage Issues Manual

will be published at least quarterly in

the Federal Register. We also sometimes

issue proposed or final national

coverage decision changes in separate

Federal Register notices. Readers

should find this an easy way to identify

both issuance changes to all our

manuals and the text of changes to the

Coverage Issues Manual.

Revisions to the Coverage Issues

Manual are not published on a regular

basis but on an as-needed basis. We

publish revisions as a result of

technological changes, medical practice

changes, responses to inquiries we

receive seeking clarifications, or the

resolution of coverage issues under

Medicare. If no Coverage Issues Manual

revisions were published during a

particular quarter, our listing will reflect

that fact.

Not all revisions to the Coverage

Issues Manual contain major changes.

As with any instruction, sometimes

minor clarifications or revisions are

made within the text. We have reprinted

manual revisions as transmitted to

manual holders. The new text is shown

in italics. We will not reprint the table

of contents, since the table of contents

serves primarily as a finding aid for the

user of the manual and does not identify

items as covered or not.

III. How to Use the Addenda

This notice is organized so that a

reader may review the subjects of all

manual issuances, memoranda,

substantive and interpretive regulations,

or coverage decisions 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 identifies

updates that changed the Coverage

Issues Manual. We published notices in

the Federal Register that included the

text of changes to the Coverage Issues

Manual. These updates, when added to

material from the manual published on

August 21, 1989 constitute a complete

manual as of December 31, 1994. Parties

interested in obtaining a copy of the

manual and revisions should follow the

instructions in section IV of this notice.

Addendum II identifies previous

Federal Register documents that

contain a description of all previously

published HCFA Medicare and

Medicaid manuals and memoranda.

Addendum III of this notice lists, for

each of our manuals or Program

Memoranda, a HCFA transmittal

number unique to that instruction and

its subject matter. A transmittal may

consist of a single instruction or many.

Often it is necessary to use information

in a transmittal in conjunction with

information currently in the manuals.

Addendum IV sets forth the revisions

to the Medicare Coverage Issues Manual

that were published during the quarter

covered by this notice. For the revisions,

we give a brief synopsis of the revisions

as they appear on the transmittal sheet,

the manual section number, and the title

of the section. We present a complete

copy of the revised material, no matter

how minor the revision, and identify the

revisions by printing in italics the text

that was changed. If the transmittal

includes material unrelated to the

revised section, for example, when the

addition of revised material causes other

sections to be repaginated, we do not

reprint the unrelated material.

Addendum V lists all substantive and

interpretive Medicare and Medicaid

regulations and general notices

published in the Federal Register

during the quarter covered by this

notice. For each item, we list the date

published, the Federal Register citation,

the title of the regulation, the parts of

the Code of Federal Regulations (CFR)

which have changed (if applicable), the

agency file code number, the ending

date of the comment period (if

applicable), and the effective date (if

applicable).
17540 Federal Register / Vol. 60, No. 66 / Thursday, April 6, 1995 / Notices

IV. How to Obtain Listed Material

A. Manuals

An individual or organization

interested in routinely receiving any

manual and revisions to it may purchase

a subscription to that manual. Those

wishing to subscribe should contact

either the Government Printing Office

(GPO) or the National Technical

Information Service (NTIS) at the

following addresses:

Superintendent of Documents,

Government Printing Office, Attn:

New Order, P.O. Box 371954,

Pittsburgh, PA 15250–7954,

Telephone (202) 512–1800, Fax

number (202) 512–2250 (for credit

card orders); or

National Technical Information Service,

Department of Commerce, 5825 Port

Royal Road, Springfield, VA 22161,

Telephone (703) 487–4630.

In addition, individual manual

transmittals and Program Memoranda

listed in this notice can be purchased

from NTIS. Interested parties should

identify the transmittal(s) they want.

GPO or NTIS can give complete details

on how to obtain the publications they

sell.

B. Regulations and Notices

Regulations and notices are published

in the daily Federal Register. Interested

individuals may purchase individual

copies or subscribe to the Federal

Register by contacting the GPO at the

address indicated above. When ordering

individual copies, it is necessary to cite

either the date of publication or the

volume number and page number.

C. Rulings

Rulings are published on an

infrequent basis by HCFA. Interested

individuals can obtain copies from the

nearest HCFA Regional Office or review

them at the nearest regional depository

library. We also sometimes publish

Rulings in the Federal Register.

D. HCFA’s Compact Disk-Read Only

Memory (CD–ROM)

HCFA’s laws, regulations, and

manuals are now 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 contained 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, 1993. The remaining portions

of CD–ROM are updated on a monthly

basis.

The CD–ROM disk does not contain

Appendix M (Interpretative Guidelines

for Hospices). Copies of this appendix

may be reviewed at a Federal Depository

Library (FDL).

Any cost report forms incorporated in

the manuals are included on the CD–

ROM disk as LOTUS files. LOTUS

software is needed to view the reports

once the files have been copied to a

personal computer disk.

V. How to Review Listed Material

Transmittals or Program Memoranda

can be reviewed at a local 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, individuals should contact

any library.

In addition, individuals may contact

regional depository libraries, which

receive and retain at least one copy of

most Federal government publications,

either in printed or microfilm form, for

use by the general public. These

libraries provide reference services and

interlibrary loans; however, they are not

sales outlets. Individuals may obtain

information about the location of the

nearest regional depository library from

any library. Superintendent of

Documents numbers for each HCFA

publication are shown in Addendum III,

along with the HCFA publication and

transmittal numbers. To help FDLs

locate the instruction, use the

Superintendent of Documents number,

plus the HCFA transmittal number. For

example, to find the Carriers Manual,

Part 2—Program Administration (HCFAPub. 14–2) transmittal entitled ‘‘Files

Maintenance Program General’’, use the

Superintendent of Documents No. HE

22.8/6–2 and the HCFA transmittal

number 127.

VI. General Information

It is possible that an interested party

may have a specific information need

and not be able to determine from the

listed information whether the issuance

or regulation would fulfill that need.

Consequently, we are providing

information contact persons to answer

general questions concerning these

items. Copies are not available through

the contact persons. Copies can be

purchased or reviewed as noted above.

Questions concerning Medicare items

in Addenda III may be addressed to

Margaret Cotton, Issuances Staff, Bureau

of Program Operations, Health Care

Financing Administration, Room 688

East High Rise, 6325 Security Blvd.,

Baltimore, MD 21207, Telephone (410)

966–5255.

Questions concerning Medicaid items

in Addenda III may be addressed to Pat

Prete, Medicaid Bureau, Office of

Medicaid Policy, Health Care Financing

Administration, Room 233 East High

Rise, 6325 Security Blvd., Baltimore,

MD 21207, Telephone (410) 966–3246.

Questions concerning all other

information may be addressed to

Michael Robinson, Office of

Regulations, Health Care Financing

Administration, Room 132 East High

Rise, 6325 Security Blvd., Baltimore,

MD 21207, Telephone (410) 966–5633.

(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: March 23, 1995.

Bruce C. Vladeck,

Administrator, Health Care Financing

Administration.

Addendum I

This addendum lists the publication

dates of the most recent quarterly listing

of program issuances and coverage

decision updates to the Coverage Issues

Manual. For a complete listing, please

refer to the listing in the January 3, 1995

quarterly notice (60 FR 132).

March 17, 1994 (59 FR 12610)

August 5, 1994 (59 FR 40038)

November 14, 1994 (59 FR 56501)

January 3, 1995 (60 FR 132)

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. 60, No. 66 / Thursday, April 6, 1995 / Notices 17541

ADDENDUM III.—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS

[October Through December 1994]

Trans. No. Manual/Subject/Publication Number

Intermediary Manual

Part 2—Audits, Reimbursement

Program Administration (HCFA–Pub. 13–2)

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

400 • Files Maintenance Program—General.

Records Retention and Disposal Schedule.

Retention of Claims Files Materials.

Microfilming of Files Material.

Intermediary—Federal Records Center Relations.

Location of Federal Records Centers.

Procedures for Transfer of Material to Federal Records Centers.

Requesting Forms for Transfer and Return of Material from Federal Records Centers.

Report of Medicare Records—Form HCFA–2556.

Exhibits.

401 • Location of Federal Records Centers.

Intermediary Manual

Part 3—Claims Process (HCFA–13–3)

(Superintendent of Documents No. HE 22.8/6)

1636 • Responsibility for Medicare Secondary Payer Outreach Program.

Quarterly Supplement to Intermediary Workload Report (Form HCFA–1566A) General.

Completing Quarterly Supplement to the Intermediary Workload Report, HCFA–1566A, Pages 1 and 2.

Completing Quarterly Supplement to the Intermediary Workload Report, HCFA–1566A, Page 3.

Completing Quarterly Periodic Interim Payment Report, HCFA–1566C—General.

1637 • Reporting Outpatient Surgery and Other Services.

PPS Pricer Program.

Provider-Specific Data Record Layout and Description.

1638 • Mammography Screening.

Mammography Quality Standards Act.

1639 • Disallowance Form Letters HCFA–1954 and HCFA–1955.

Explanation of Medicare Benefits Notice Specifications.

1640 • General Effect of Liability Insurance on Medicare Payment.

Appeals Procedures for MSP Liability Overpayments.

1641 • Mammography Screening.

Carriers Manual

Part 2—Program Administration (HCFA–14–2)

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

127 • Files Maintenance Program—General.

Records Retention and Disposal Schedule.

Retention of Claims Files Materials.

Microfilming of Files Materials.

Report of Medicare Records—Form HCFA–2556.

Location of Federal Records Centers.

Procedures for Transfer of Material to Federal Records Centers.

Requesting Forms for Transfer and Return of Material from Federal Records Centers.

Exhibits.

128 • Location of Federal Records Centers.

Carriers Manual

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

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

9 • Responsibility in the Medicare Secondary Payer Outreach Program.

10 • National Registry of Physicians/Health Care Practitioners/Group Practices-Medicare Provider Identifier (UPIN).

Ongoing Data Collection On Physicians/Health Care Practitioners/Group Applications.

Physicians/Health Care Practitioners/Group Practices Record-Required Information and Format.

Maintaining Physicians/Health Care Practitioner/Group Practice Membership.

Validation of Physicians/Health Care Practitioners/Group Practices Credentials, Certifications, Sanction and License Information for Prior Practice.

• UPIN Cross Referral Requirement.

Maintenance of The Registry.

Update Records.

Rejections.

Exceptions.

Carrier Record Requirements.

UPIN Carrier Record Layout.
17542 Federal Register / Vol. 60, No. 66 / Thursday, April 6, 1995 / Notices

ADDENDUM III.—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS—Continued

[October Through December 1994]

Trans. No. Manual/Subject/Publication Number

List of Medical School Codes.

Carriers Manual

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

(Superintendent of Documents No. HE 22.8/7)

1501 • Quarterly Supplements to the Carrier Performance Report (Forms HCFA–1565A, HCFA–1565B, HCFA–1565C, and HCFA–

1565D)—General.

Completing Form HCFA–1565A.

Completion of Items on Form HCFA–1565A.

Completing Medicare Fraud Unit Quarterly Workload Status Report, HCFA–1565B—General.

Completing Form HCFA–1565C.

Completion of Items on Form HCFA–1565C.

Completing Comprehensive Limiting Charge Compliance Program Quarterly Report HCFA–1565D—General.

Completing Medicare Fraud Unit Quarterly Status Report, Form HCFA–1565B.

Completing Carrier Limiting Charge Compliance Program Quarterly Report, Form HCFA–1565D.

1502 • Chiropractors.

Manual Manipulation.

Verification of Chiropractor’s Qualifications.

1503 • Part B Provider Access to Limited Eligibility Data.

Eligibility Data Available.

Contractor Implementation.

Data Format.

Part B Eligibility Data Security Requirements.

HCFA Standard Part B Eligibility Data Security Requirements.

HCFA Standard Part B Eligibility Inquiry Flat File Specifications.

HCFA Standard Part B Eligibility Response Flat File Specifications.

1504 • Type of Service.

1505 • Self-Administering of Drug or Biological.

1506 • List of Covered Surgical Procedures.

1507 • Rebundling of CPT–4 Codes.

Program Memorandum

Intermediaries (HCFA–Pub. 60A)

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

A–94–8 • Revised Wages Indexes for Ambulatory Surgical Centers—Pricer for 7.0 and 8.0.

A–94–9 • FY 1995 Prospective Payment System and Other Bill Processing Changes.

A–94–10 • Ambulatory Surgical Center—Pricer 9.0.

Program Memorandum

Carriers (HCFA–Pub. 60B)

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

B–94–6 • 1995 Physician, Practitioner and Supplier Participation Enrollment and Fee Schedule Disclosure.

B–94–7 • 1995 Physician, Practitioner and Supplier Participation Enrollment and Fee Schedule Disclosure.

B–94–8 • Split Billing for Professional and Technical Components of Services.

Program Memorandum

Intermediaries/Carriers (HCFA–Pub. 60AB)

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

AB–94–8 • Revised Codes for Part B Ground Ambulance Services.

Program Memorandum

Medicaid State Agencies (HCFA–Pub. 17)

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

94–8 • Title XIX, Social Security Act, Vaccines for Children Program.

94–9 • Title XIX, Social Security Act, Personal Care Services Provided in a Home or Other Location.

Regional Office Manual

Standards and Certification (HCFA–Pub. 23–4)

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

55 • Developing the Budget Approval.

Submittal of Budget Approval.

Distribution of Approved Funds.

Disbursement of Authorized Funds.
Federal Register / Vol. 60, No. 66 / Thursday, April 6, 1995 / Notices 17543

ADDENDUM III.—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS—Continued

[October Through December 1994]

Trans. No. Manual/Subject/Publication Number

The Budget Call.

Monitoring State Agency Fiscal Budgets.

56 • Approval Procedures for Hospitals in the 50–99 Bed Category.

Peer Review Organization Manual

(HCFA–Pub. 19)

(Superintendent of Documents No. HE 22.8/15)

40 • Introduction.

MOA with State Agencies Responsible for Licensing/Certification of Providers/Practitioners.

Model Memorandum of Agreement.

41 • Complaints to be Reviewed.

Disposition of Complaints.

Disclosing Information.

Monitoring Hospital-Issued Notices of Noncoverage.

Beneficiary Liability.

Model Hospital-Issued Notice of Noncoverage Continued Stay—Swing Bed Only.

42 • DRG Validation Review.

43 • Training.

Hospital Manual

(HCFA–Pub. 10)

(Superintendent of Documents No. HE 22.8/2)

673 • Billing for Mammography Screening.

Mammography Quality Standards Act.

674 • Billing for Mammography Screening.

Skilled Nursing Facility

(HCFA–Pub. 12)

(Superintendent of Documents No. HE 22.8/3)

332 • Billing for Mammography Screening.

Mammography Quality Standards Act.

333 • Billing for Mammography Screening.

State Medicaid Manual

Part 3—Eligibility (HCFA–Pub. 45–3)

(Superintendent of Documents No. HE 22.8/10)

64 • Transfers of Assets for Less Than Fair Market Value.

Treatment of Trusts.

State Medicaid Manual

Part 6—Payment for Services (HCFA–Pub. 45–6)

(Superintendent of Documents No. HE 22.8/10)

26 • Listing of Multiple Source Drugs.

State Medicaid Manual

Part 7—Quality Control (HCFA–Pub. 45–7)

(Superintendent of Documents No. HE 22.8/10)

52 • Computations of Financial Eligibility.

Verification Guide—Coverage Code 02 for OASDI Recipients.

Verification Guide—Coverage Code 01 or 03.

Verification Guide—Coverage Code 18 for QDWI Individuals.

Verification Guide—Coverage Code 25 for Individuals Whose Eligibility for Medicaid Has Otherwise Ceased.

Verification Guide—Coverage Code 26 for Individuals Whose Eligibility for Medicaid Has Otherwise Ceased.

Verification Guide—Coverage Code 29 for Individuals Receiving Home and Community-Based Services and Other Waiver

Services.

Verification Guide—Coverage Code 31.

Verification Guide—Coverage Code 40 for AFDC Families.

Coverage Issues Manual

(HCFA–Pub. 6)

(Superintendent of Documents No. HE 22.8/14)

72 • Blood Transfusions.
17544 Federal Register / Vol. 60, No. 66 / Thursday, April 6, 1995 / Notices

ADDENDUM III.—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS—Continued

[October Through December 1994]

Trans. No. Manual/Subject/Publication Number

73 • Hydrophilic Contact Lens for Corneal Bandage.

Home Health Agency Manual

(HCFA–Pub. 11)

(Superintendent of Documents No. HE 22.8/5)

273 • Home Health Certification and Plan of Care.

State Operations Manual

Provider Certification (HCFA–Pub. 7)

(Superintendent of Documents No. HE 22.8/12)

265 • Hospice Regulations and Non-Medicare Patients.

Operation of a Hospice Across State Lines.

Compliance with Advance Directives.

Hospice—Citations and Description.

Hospice Multiple Locations.

Election of Hospice Benefit by Resident of a Skilled Nursing Facility, Nursing Facility, Intermediate Care Facility for the Mentally Retarded, or Non-Certified Facility.

Hospice Inpatient Services Furnished Directly or Furnished Under Arrangements.

Hospice Home Visit Procedures.

Model Consent for Hospice Home Visit Form.

Hospice Survey and Deficiencies Report.

Interpretive Guidelines—Hospices.

Rural Health Clinic and Federally

Qualified Health Centers Manual (HCFA–Pub. 27)

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

16 • Billing for Mammography Screening by Rural Health Clinic and Federally Qualified Health Centers.

Mammography Qualified Standards Act.

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

Medicare/Medicaid

Sanction—Reinstatement Report

94–13 • Report of Physician/Practitioners, Providers and/or Other Health Care Suppliers Excluded/Reinstated.

94–14 • Report of Physician/Practitioners, Providers and/or Other Health Care Suppliers Excluded/Reinstated.

Addendum IV—Medicare Coverage

Issues Manual

(For the reader’s convenience, new

material and changes to previously

published material are in italics. If any

part of a sentence in the manual

instruction has changed, the entire line

is shown in italics. The transmittal

includes material unrelated to revised

sections. We are not reprinting the

unrelated material.)

Transmittal No. 72; section 45–27

Blood Transfusions NEW

INPLEMENTING INSTRUCTIONS—

EFFECTIVE DATE: For services

performed on or after 12–08–94.

Section 45–27, Blood Transfusions.—

This section has been added to clarify

the coverage and payment policies for

blood transfusions.

45–27 BLOOD TRANSFUSIONS

Blood transfusions are used to restore

blood volume after hemorrhage, to

improve the oxygen carrying capacity of

blood in severe anemia, and to combat

shock in acute hemolytic anemia.

A. Definitions.—

1. Homologous Blood Transfusion.—

Homologous blood transfusion is the

infusion of blood or blood components

that have been collected from the

general public.

2. Autologous Blood Transfusion.—

An autologous blood transfusion is the

precollection and subsequent infusion

of a patient’s own blood.

3. Donor Directed Blood

Transfusion.—A donor directed blood

transfusion is the infusion of blood or

blood components that have been

precollected from a specific

individual(s) other than the patient and

subsequently infused into the specific

patient for whom the blood is

designated. For example, patient B’s

brother predeposits his blood for use by

patient B during upcoming surgery.

4. Perioperative Blood Salvage.—

Perioperative blood salvage is the

collection and reinfusion of blood lost

during and immediately after surgery.

B. Policy Governing Transfusions.—

For Medicare coverage purposes, it is

important to distinguish between a

transfusion itself and preoperative

blood services; e.g., collection,

processing, storage. Medically necessary

transfusion of blood, regardless of the

type, may generally be a covered service

under both Part A and Part B of

Medicare. Coverage does not make a

distinction between the transfusion of

homologous, autologous, or donordirected blood. With respect to the

coverage of the services associated with

the preoperative collection, processing,

and storage of autologous and donordirected blood, the following policies

apply.

1. Hospital Part A and B Coverage

and Payment.—Under § 1862(a)(14) of

the Act, nonphysician services

furnished to hospital patients are

covered and paid for as hospital

services. The inclusion of services
Federal Register / Vol. 60, No. 66 / Thursday, April 6, 1995 / Notices 17545

provided to hospital patients by an

outside supplier as part of hospital

services is referred to as ‘‘bundling.’’ In

a situation where a hospital obtains

either autologous or donor-directed

blood from an independent supplier, the

supplier collects, processes, and stores

the blood and, typically, delivers it to

the hospital. The hospital is responsible

for paying the supplier.

Part A payment, as specified in

§ 1814(b) of the Act, and Part B

payment, as specified in § 1833(a) of the

Act, relate to reasonable cost as defined

in § 1861(v) of the Act. Under this

system, when a hospital obtains

autologous or donor-directed blood from

an independent blood bank, Medicare

recognizes only a processing fee charged

to the hospital by the independent blood

bank because the blood has been

replaced, albeit in advance. The

processing fee is recorded by the

hospital in the blood storing, processing,

and transfusion cost center. This cost

center also includes any costs the

hospital itself incurs to process and

administer the blood after it has been

procured. This includes the cost of such

activities as storing, type crossmatching,

and transfusing the blood, as well as the

cost of spoiled or defective blood. The

hospital may generate a charge for these

costs (except for spoiled or defective

blood) and, under cost reimbursement,

Medicare picks up its share of the costs

through cost apportionment. As

provided in § 1886 of the Act, under the

prospective payment system (PPS), the

diagnosis related group (DRG) payment

to the hospital includes all covered

blood and blood processing expenses,

whether or not the blood is eventually

used.

In a situation where the hospital

operates its own blood collection

activities, rather than using an

independent blood supplier, the costs

incurred to collect autologous or donordirected blood are recorded in the whole

blood and packed red blood cells cost

center. Because the blood has been

replaced, Medicare does not recognize a

charge for the blood itself. Therefore,

under cost reimbursement, these costs

are shared by all patients through cost

apportionment. The costs incurred by

the hospital to store, process, and

transfuse the blood, as well as the cost

of spoiled or defective blood, are

recorded in the blood storing,

processing, and transfusion cost center.

The hospital may generate a charge for

these costs (except for the cost of

spoiled or defective blood) and, under

cost reimbursement, Medicare picks up

its share of these costs through cost

apportionment. Under PPS, the DRG

payment is intended to pay for all

covered blood and blood services,

whether or not the blood is eventually

used.

Under its provider agreement, a

hospital is required to furnish or arrange

for all covered services furnished to

hospital patients. Medicare payment is

made to the hospital, under PPS or cost

reimbursement, for covered inpatient

and outpatient services, and it is

intended to reflect payment for all costs

of furnishing those services.

2. Nonhospital Part B Coverage.—

Under Part B, to be eligible for separate

coverage, a service must fit the

definition of one of the services

authorized by § 1832 of the Act. These

services are defined in 42 CFR 410.10

and do not include a separate category

for a supplier’s services associated with

blood donation services, either

autologous or donor-directed. That is,

the collection, processing, and storage

of blood for later transfusion into the

beneficiary is not recognized as a

separate service under Part B.

Therefore, there is no avenue through

which a blood supplier can receive

direct payment under Part B for blood

donation services.

C. Perioperative Blood Salvage.—

When the perioperative blood salvage

process is used in surgery on a hospital

patient, payment made to the hospital

(under PPS or through cost

reimbursement) for the procedure in

which that process is used is intended

to encompass payment for all costs

relating to that process.

Transmittal No. 73; Section 45–7,

Hydrophilic Contact Lens for Corneal

Bandage. CLARIFICATION—

EFFECTIVE DATE: Not Applicable.

Section 45–7, Hydrophilic Contact

Lens for Corneal Bandage.—This section

has been revised to explain how

payment is provided for hydrophilic

contact lenses when they are furnished

incident to a physician’s services.

Payment for the lenses is bundled into

the payment for the physician service to

which it is incident. If the lenses are

covered as other than incident to a

physician’s service, they are not paid

under the physicians’ fee schedule and

would be covered prosthetic devices,

which follow other payment provisions

of the Act.

45–7 HYDROPHILIC CONTACT LENS

FOR CORNEAL BANDAGE

Some hydrophilic contact lenses are

used as moist corneal bandages for the

treatment of acute or chronic corneal

pathology, such as bullous keratopathy,

dry eyes, corneal ulcers and erosion,

keratitis, corneal edema, descemetocele,

corneal ectasis, Mooren’s ulcer, anterior

corneal dystrophy, neurotrophic

keratoconjunctivitis, and for other

therapeutic reasons.

Payment may be made under

§ 1861(s)(2) of the Act for a hydrophilic

contact lens approved by the Food and

Drug Administration (FDA) and used as

a supply incident to a physician’s

service. Payment for the lens is included

in the payment for the physician’s

service to which the lens is incident.

Contractors are authorized to accept an

FDA letter of approval or other FDA

published material as evidence of FDA

approval. (See § 65–1 for coverage of a

hydrophilic contact lens as a prosthetic

device.) See Intermediary Manual,

§ 3112.4 and Carriers Manual, §§ 2050.1

and 15010.

ADDENDUM V.—REGULATION DOCUMENTS PUBLISHED IN THE FEDERAL REGISTER

Publication

date

FR page

numbers CFR part File code* Regulation title End of comment period

Effective

date

10/03/94 ............ 50235–50240 ........................... MB–084–NC Medicaid Program; Charges for

Vaccine Administration Under

the Vaccines for Children (VFC)

Program.

................... 10/01/94

10/03/94 ............ 50246–50253 ........................... ORD–068–N Medicare and Medicaid Programs; Small Business Innovation Research Grants for Fiscal

Year 1995.

................... 10/03/94

10/07/94 ............ 51125–51130 403 OBS–001–FC Medicare Program; Information,

Counseling, and Assistance

Grants Program.

12/06/94 10/07/94
17546 Federal Register / Vol. 60, No. 66 / Thursday, April 6, 1995 / Notices

ADDENDUM V.—REGULATION DOCUMENTS PUBLISHED IN THE FEDERAL REGISTER—Continued

Publication

date

FR page

numbers CFR part File code* Regulation title End of comment period

Effective

date

10/13/94 ............ 51989 ........................... MB–084–CN Medicaid Program; Charges for

Vaccine Administration Under

the Vaccines for Children (VFC)

Program Correction.

12/12/94 10/01/94

10/14/94 ............ 52129–52132 418 BPD–820–N Hospice Services Under Medicare

Program; Intent To Form Negotiated Rulemaking Committee.

11/14/94 10/14/94

10/19/94 ............ 52862 488 489 BPD–393–IFC Medicare Program; Participation

in CHAMPUS and CHAMPVA,

Hospital Admissions for Veterans, Discharge Rights Notice,

and Hospital Responsibility for

Emergency Care OFR Correction.

08/22/94 07/22/94

10/20/94 ............ 52968–52971 ........................... HSQ–220–N CLIA Program; Approval of the

American Society for

Histocompatibility and

Immunogenetics for the Specialty of Histocompatibility.

................... 10/20/94

10/20/94 ............ 52971–52972 ........................... OPL–002–N Medicare Program; Request for

Nominations for Members for

the Practicing Physicians Advisory Council.

................... 10/20/94

10/21/94 ............ 53187–53193 ........................... BPO–124–PN Medicare Program; Data, Standards, and Methodology Used to

Establish Fiscal Year 1995

Budgets for Fiscal

Intermediaries and Carriers.

12/20/94 ...................

11/10/94 ............ 56116–56252 401 431 435

440 441 442

447 483 488

489 498

HSQ–156–F Medicare and Medicaid Programs, Survey, Certification

and Enforcement of Skilled

Nursing Facilities and Nursing

Facilities.

................... 07/01/95

11/14/94 ............ 56501–56510 ........................... BPO–127–N Medicare and Medicaid Programs; Quarterly Listing of Program Issuances and Covered

Decisions-Second Quarter 1994.

................... 11/14/94

11/16/94 ............ 59241–61629 ........................... BPO–128–N Medicare and Medicaid Programs; Delay in Implementation

of the Medicare-Medicaid Coverage Data Bank Requirements.

................... 11/16/94

11/17/94 ............ 59624 ........................... MB–060–P Medicaid Program; Inpatient Psychiatric Services for Individuals

Under Age 21.

01/17/94 ...................

11/21/94 ............ 59933–59943 417 OMC–008–F Medicare Program; Appeal Rights

and Procedures for Beneficiaries Enrolled in Prepaid

Health Care Plans.

................... 12/21/94

11/22/94 ............ 60109–60156 205 MB–092–P Aid to Families With Dependent

Children; National Voter Registration Act of 1993; Implementation.

01/23/95 ...................

11/23/94 ............ 60365 ........................... OPL–003–N Medicare Program; Meeting of the

Practicing Physicians Advisory

Council.

................... 11/23/94

12/01/94 ............ 61629–61628 ........................... OACT–046–N Medicare Program; Part A Premium for 1995 for the Uninsured Aged and for Certain Disabled Individuals Who Have

Exhausted Other Entitlement.

................... 01/01/95

12/01/94 ............ 61629–61633 ........................... OACT–047–N Medicare Program; Monthly Actuarial Rates and Monthly Supplementary Medical Insurance

Premium Rates Beginning January 1, 1995.

................... 01/01/95

12/01/94 ............ 61628–61633 ........................... OACT–048–N Medicare Program; Inpatient Hospital Deductible and Hospital

and Extended Care Services

Coinsurance Amounts for 1995.

................... 01/01/95
Federal Register / Vol. 60, No. 66 / Thursday, April 6, 1995 / Notices 17547

ADDENDUM V.—REGULATION DOCUMENTS PUBLISHED IN THE FEDERAL REGISTER—Continued

Publication

date

FR page

numbers CFR part File code* Regulation title End of comment period

Effective

date

12/06/94 ............ 62606–62609 493 HSQ–217–FC Medicare, Medicaid and CLIA

Programs; Extension of Certain

Effective Dates for Clinical Laboratory Requirements and Personnel Requirements for

Cytologists.

02/06/95 12/06/94

12/08/94 ............ 63410–63635 410 414 BPD–789–FC Medicare Program; Refinements

to Geographic Adjustment Factor Values, Revisions to Payment Policies, Adjustments to

the Relative Value Units

(RVUs) Under The Physician

Fee Schedule for Calender

Year 1995, and the 5–Year Refinement of RVUs.

02/06/95 01/01/95

12/08/94 ............ 63638–63646 ........................... BPD–807–FN Physician Fee Schedule Update

for Calendar Year 1995 and

Physician Volume Performance

Standard Rates of Increase for

Federal Fiscal Year 1995.

................... 01/01/95

12/13/94 ............ 64141–64153 405 482 BPD–421–F Medicare and Medicaid Programs; Revisions to Conditions

of Participation for Hospitals.

................... 01/12/95

12/13/94 ............ 64153–64156 412 413 BPD–802–CN Medicare Program; Changes to

the Hospital Inpatient Prospective Systems and Fiscal Year

1995 Rates; Correction.

................... 10/01/94

12/20/94 ............ 64482–65498 409 413 418

484

BPD–469–F Medicare Program; Medicare

Coverage of Home Health

Services, Medicare Conditions

of Participation, and Home

Health Aide Supervision.

................... 02/21/95

12/23/94 ............ 66314–66316 ........................... HSQ–221–N Medicare, Medicaid, and CLIA

Programs; Clinical Laboratory

Improvement Amendments of

1988 Continuance of Exemption of Laboratories Licensed

by the State of Washington.

................... 12/29/94

12/29/94 ............ 67264–67265 ........................... BPD–822–N Medicare Program; Hospice

Wage Index.

................... 12/29/94

12/29/94 ............ 67265 ........................... BPD–823–N Medicare Program; Hospice

Wage Index.

................... 12/29/94

*GN—General Notice; PN—Proposed Notice; FN—Final Notice; P—Notice of Proposed Rulemaking (NPRM); F—Final Rule; FC—Final Rule

with Comment Period; CN—Correction Notice; SN—Suspension Notice; WN—Withdrawal Notice; NR—Notice of HCFA Ruling.

[FR Doc. 95–8398 Filed 4–5–95; 8:45 am]

BILLING CODE 4120–01–P

Health Resources and Services

Administration

Maternal and Child Health Services;

Federal Set-Aside Program; Genetic

Services and Maternal and Child

Improvement Projects for Fiscal Year

(FY) 1995: Cancellation/Changes of

Cycle for Certain Grants and

Cooperative Agreements; Extension of

Certain Application Deadline Dates

Notice of Availability of Funds for

Special Project Grants and Cooperative

Agreements; Maternal and Child Health

Services; Federal Set-Aside Program;

Genetic Services and Maternal and

Child Improvement Projects for fiscal

year (FY) 1995, section 502(a), title V of

the Social Security Act, was published

on February 13, 1995, at 60 FR 8244.

Section 4.1.2.1. of this notice

announced the availability of funds for

4–6 grants in the Maternal, Infant, Child

and Adolescent Health subcategory

priority identified as ‘‘Adolescent

Health Resource Center.’’ Section

4.1.2.3. of this notice announced the

availability of funds for 5 grants in the

Data Utilization subcategory,

Since publication of this notice, it has

been determined that amounts allocated

for grants under Section 4.1.2.1. are

insufficient to permit the award of 4–6

grants in the ‘‘Adolescent Health

Resource Center’’ priority for FY 1995.

As a result, this competition will award

one grant in FY 1995 of $200,000 per

year for up to 5 years. The programmatic

and technical information contact for

this competition is Juanita Evans,

M.S.W., telephone: (301) 443–4026.

Additionally, it has been determined

that amounts allocated for grants under

Section 4.1.2.2. are insufficient to

permit the award of 3 grants in the

‘‘Mental Health Resource Grants’’

priority for FY 1995. As a result, this

competition will award 2 grants in FY

1995 of $500,000 each per year for up

to 5 years. Finally, it has been

determined that amounts allocated for

grants under Section 4.1.2.3. are

insufficient to permit the award of 5

grants in FY 1995 of $100,000 each per

year for 3 years. As a result, this

competition will award up to 5 grants

totalling up to $200,000 in FY 1995,

with awards ranging between $25,000 to

$100,000 each per year for up to 3 years.

Three of the deadline dates

announced in the February 13 Notice of