25738 Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Notices

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, access

HCFA’s web site address at http://

www.hcfa.gov/regs/prdact95.htm, or Email your request, including your

address and phone number, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the OMB Desk Officer designated at the

following address: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, D.C. 20503.

Dated: April 17, 2000.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA,

Office of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 00–11036 Filed 5–2–00; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–246]

Emergency Clearance: Public

Information Collection Requirements

Submitted to the Office of Management

and Budget (OMB)

AGENCY: Health Care Financing

Administration, HHS.

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

We are, however, requesting an

emergency review of the Information

collections referenced below. In

compliance with the requirement of

section 3506(c)(2)(A) of the Paperwork

Reduction Act of 1995, we have

submitted to the Office of Management

and Budget (OMB) the following

requirements for emergency review. Due

to the unanticipated event of the

settlement agreement for the Grijalva

court case requiring HCFA to revise the

current instrument, and because the

collection of this information is needed

prior to the expiration of the normal

time limits under OMB’s regulations at

5 CFR Part 1320, we are requesting

emergency review. The Agency cannot

reasonably comply with the normal

clearance procedures because public

harm is likely to result due to the

possibility of the Medicare program

being unable to provide the necessary

mandated information on whether

Medicare+Choice organizations are

meeting their notice and appeal

requirements. Additional questions

have been added to the survey that

address the following: enrollee

knowledge about appeal rights and the

appeals process; whether the enrollee

ever was denied care; whether the

enrollee was given written notice of the

right to file a formal complaint; and

whether the enrollee ever filed a

complaint with his/her

Medicare+Choice organization.

HCFA is requesting OMB review and

approval of this collection by July 3,

2000, with a 180-day approval period.

Written comments and

recommendations will be accepted from

the public if received by the individuals

designated below by June 28, 2000.

During this 180-day period, we will

publish a separate Federal Register

notice announcing the initiation of an

extensive 60-day agency review and

public comment period on these

requirements. We will submit the

requirements for OMB review and an

extension of this emergency approval.

Type of Information Collection

Request: Revision of a currently

approved collection;

Title of Information Collection: The

Medicare Managed Care CAHPS Survey

and Supporting Regulations in 42 CFR

417.126 and 417.470;

Form No.: HCFA-R–246 (OMB #0938–

0732);

Use: The CAHPS data is necessary to

hold the Medicare managed care

industry accountable for the quality of

care they are delivering. It is critical to

HCFA’s mission that we collect and

disseminate information that will help

beneficiaries choose among plans,

contribute to improved quality of care

through identification of quality

improvement opportunities, and assist

HCFA in carrying out its

responsibilities;

Frequency: On occasion;

Affected Public: Individuals or

households, business or other for-profit,

and not-for-profit institutions;

Number of Respondents: 204,000;

Total Annual Responses: 204,000;

Total Annual Hours: 67,320.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326.

Interested persons are invited to send

comments regarding the burden or any

other aspect of these collections of

Information requirements. However, as

noted above, comments on these

Information collection and

recordkeeping requirements must be

mailed and/or faxed to the designees

referenced below, by June 28, 2000:

Health Care Financing Administration,

Office of Information Services,

Security and Standards Group,

Division of HCFA Enterprise

Standards, Attention: Dawn

Willinghan, Room N2–14–26, 7500

Security Boulevard, Baltimore,

Maryland 21244–1850

and

Office of Information and Regulatory

Affairs, Office of Management and

Budget, Room 10235, New Executive

Office Building, Washington, DC

20503, Fax Number: (202) 395–6974

or (202) 395–5167 Attn: Allison

Herron Eydt, HCFA Desk Officer.

Dated: April 24, 2000.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 00–11038 Filed 5–2–00; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–3030–N]

RIN 0938–AH15

Medicare Program; Lenses Eligible for

an Adjustment in Payment Amount for

New Technology Intraocular Lenses

Furnished by Ambulatory Surgical

Centers

AGENCY: Health Care Financing

Administration (HCFA), HHS.

Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Notices 25739

ACTION: Notice.

SUMMARY: This notice announces the

lenses that we have determined meet

the criteria and definition of a new

technology intraocular lens (NTIOL).

These lenses are eligible for a payment

adjustment of $ 50 when furnished by

an ambulatory surgical center (ASC).

DATES: Effective date of this notice: May

18, 2000.

Expiration date of this notice: May 18,

2005.

FOR FURTHER INFORMATION CONTACT:

Mary Stojak, (410) 786–6939.

SUPPLEMENTARY INFORMATION:

Background

In our regulations at 42 CFR Part 416,

Subpart F, we describe the process an

interested party may use to request that

we review the appropriateness of the

payment amount for NTIOLs furnished

by ASCs. On December 20, 1999, we

published a notice with comment

period (64 FR 71148) listing lenses for

which we had received requests for a

review for payment adjustment. In

accordance with those regulations, we

asked the FDA to review the requests to

determine whether the claims of

specific clinical advantage and

superiority over existing intraocular

lenses had been approved for labeling

and advertising purposes. HCFA uses

only FDA’s labeling review to determine

if lenses meet the NTIOL criteria. FDA

conveyed their analysis of the lenses to

HCFA in a December 22, 1999

memorandum. Based on that

information, HCFA determined that two

of the lenses met the NTIOL criteria, but

four did not. The approved lenses and

model numbers are listed in the ‘‘Lenses

Eligible for the Payment Adjustment’’

section of this notice.

The following lenses that were

considered for payment adjustment did

not meet our criteria for NTIOLs:

(1) Alcon, manufacturer of Acrysof

Models MA30BA and MA60BM,

claimed these lenses provide a

reduction in the rate of Nd:YAG

capsulotomy and posterior capsule

opacification. The FDA determined that

these lenses did not demonstrate

clinical advantages over existing lenses

with respect to the claims made by the

manufacturer.

(2) Allergan, manufacturer of AMO

Silicone Posterior Chamber Models

SI40NB and SI55NB, claimed the rate of

Nd:YAG capsulotomy and posterior

capsule opacification were lower after

two years. The FDA determined that

these lenses did not demonstrate

clinical advantages over existing lenses

for the claims made by the

manufacturer.

(3) CIBA Vision Corporation,

manufacturer of MemoryLens Models

U940A and U940S, claimed that these

lenses are the only small incision prerolled hydrophylic acrylic lenses in

today’s global market. They did not

identify any specific clinical

advantages. Based on their labeling

claims, the FDA has determined that

these lenses did not demonstrate any

specific clinical advantages over

existing lenses.

(4) Pharmacia and Upjohn,

manufacturer of CeeOn Heparin Surface

Modified Models 720C, 722C, 726C,

727C, 730C, 734C, 777C, 809C through

815C, and 820C, claimed that the

amount of cellular deposits and the

number of giant cells are reduced with

their lenses. The FDA determined that

these lenses did not demonstrate a

clinical advantage over other approved

IOLs.

We received 110 comments in

response to the notice listing the lenses

requesting a review. Of these, the

majority were from ophthalmologists.

The remainder of the comments were

from professional organizations,

ambulatory surgical centers, and one

manufacturer of intraocular lenses.

Analysis of, and Responses to, Public

Comments on Lenses Requesting

Review for an Adjustment in Payment

Amount

Comment: Over 100 of the comments

received were testimonials in support of

one or more of the lenses announced in

the notice. The support was based on

experience the commenters have had

with a lens or lenses. A summary of

these comments follow: 80 commenters

supported the Alcon Acrysof lens, 29

commenters supported the Allergan

Array Multifocal lens, 3 commenters

supported the Pharmacia & Upjohn

CeeOn lens, 3 commenters supported

the STAAR Surgical Toric Optic lens, 1

commenter supported the Allergan

AMO Silicone Posterior Chamber lens,

and 3 commenters supported all of the

lenses. These commenters suggested

that these lenses be classified as new

technology intraocular lenses, and,

therefore, be eligible for the payment

adjustment.

Response: We appreciate the

commenters’ interests in these lenses,

and are pleased that these lenses have

improved the quality of life of Medicare

beneficiaries. Regulations at 42 CFR

416.180 require the FDA to determine

whether the lens has specific clinical

advantages and superiority over existing

intraocular lenses. Testimonials that

support the claims of an intraocular lens

to be considered an NTIOL cannot

substitute for the FDA’s approval. The

FDA must rely on published clinical

data to decide that a lens has specific

clinical advantages and superiority over

existing lenses in order to be considered

an NTIOL.

Comment: Two commenters made

reference to the payment adjustment for

intraocular lenses and the need to

implement the payment process in a

timely manner.

Response: Payment issues are

outlined in our regulations at 42 CFR

416.185. This section codifies the

payment amount, and describes the time

frame for implementation of the

payment adjustment. The effective date

of the payment adjustment is 30 days

after the publication of this notice,

which must be published within 90

days of the end of the comment period

of the notice listing the lenses

requesting review. Since the Federal

Register notice listing the requests was

published on December 20, 1999 (64 FR

71148), the effective date of the payment

adjustments can be no later than May

18, 2000. Retroactive payment

adjustments will be made, if necessary.

Comment: One commenter suggested

that the manufacturers of the Alcon

Acrysof lens and the Allergan AMO

Posterior Chamber lens should not be

able to claim that their lenses are

superior to existing intraocular lenses in

the rate of Nd:YAG capsulotomy. The

commenter claims that the studies

performed by these manufacturers

showed only that their lenses were

superior to one particular model.

Response: The manufacturers of these

lenses have not demonstrated clinical

advantages and superiority over existing

lenses, as the regulations require.

Lenses Eligible for the Payment

Adjustment

In determining which lenses meet the

criteria and definition of an NTIOL, we

relied on the clinical data and evidence

submitted to the FDA by the various

manufacturers, demonstrating that these

lenses have specific clinical advantages

and superiority over existing lenses.

These claims must be approved by the

FDA for use in advertising and labeling.

The lenses eligible for a payment

adjustment are identified by a

characteristic or subset of an NTIOL.

The payment adjustment is effective for

5 years from the effective date of this

notice. Any subsequent NTIOL with the

same characteristic, and determined to

be eligible for a payment adjustment,

will receive the payment adjustment for

the remainder of the 5 year period.

Based on the FDA’s approval process as

required by our regulations, the

following lenses are eligible for a

payment adjustment of $50 when

25740 Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Notices

furnished by an ambulatory surgical

center:

Manufacturer: Allergan

Lens and Model Number: AMO Array

Multifocal Model SA40N

Characteristic: Multifocal

Procedure Code: Q1001—NTIOL

Category 1

Manufacturer: STAAR Surgical

Company

Lens and Model Numbers: Elastic

Ultraviolet-Absorbing Silicone

Posterior Chamber

Intraocular Lens with Toric Optic

Models AA4203T, AA4203TF, and

AA4203TL

Characteristic: Reduction in Preexisting

Astigmatism

Procedure Code: Q1002— NTIOL

Category 2

Payment Adjustments made to ASCs

Payment adjustments made to ASCs

that provide these lenses will be

effective on May 18, 2000 and continue

until May 18, 2005.

Authority: Sections 1832 (a)(2)(F)(i) and

1833(i)(2)(A) of the Social Security Act (42

U.S.C. 1395k(a)(2)(F)(i) and 1395l(i)(2)(A))

(Catalog of Federal Domestic Assistance

Program No. 93.778, Medical Assistance

Program; No. 93.773 Medicare—Hospital

Insurance Program; and No. 93.774,

Medicare—Supplementary Medical

Insurance Program)

Dated: April 11, 2000.

Nancy-Ann Min DeParle,

Administrator, Health Care Financing

Administration.

[FR Doc. 00–10970 Filed 5–2–00; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

Periodically, the Health Resources

and Services Administration (HRSA)

publishes abstracts of information

collection requests under review by the

Office of Management and Budget, in

compliance with the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35). To request a copy of the

clearance requests submitted to OMB for

review, call the HRSA Reports

Clearance Office on (301) 443–1129.

The following request has been

submitted to the Office of Management

and Budget for review under the

Paperwork Reduction Act of 1995:

Proposed Project: Application for the

National Health Service Corps (NHSC)

Scholarship Program (OMB No. 0915–

0146): Extension

The National Health Service Corps

(NHSC) Scholarship Program was

established to help alleviate the

geographic and specialty

maldistribution of physicians and other

health practitioners in the United States.

Under this program, health professions

students are offered scholarships in

return for service in a federally

designated Health Professional Shortage

Area (HPSA). The Scholarship Program

provides the NHSC with the health

professionals it requires to carry out its

mission of providing primary health

care to HPSA populations in areas of

greatest need. Students are supported

who are well qualified to participate in

the NHSC Scholarship Program and

who want to assist the NHSC in its

mission, both during and after their

period of obligated service. Scholars are

selected for these competitive awards

based on the information provided in

the application and during the

semistructured personal interview that

is conducted by a team of two

interviewers who use a structured

scoring procedure. Awards are made to

applicants that demonstrate a high

potential for providing quality primary

health care services.

The estimated response burden is as

follows:

Form Number of respondents

Responses

per respondents

Hours per

reponse

Total burden

hours

Application ....................................................................................................... 2,000 1 1 2,000

Interview ........................................................................................................... 1,100 1 1 1,100

Total .......................................................................................................... 3,100 ........................ ........................ 3,100

Written comments and

recommendations concerning the

proposed information collection should

be sent within 30 days of this notice to:

Wendy A. Taylor, Human Resources

and Housing Branch, Office of

Management and Budget, New

Executive Office Building, Room 10235,

Washington, D.C. 20503.

Dated: April 26, 2000.

Jane Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 00–10930 Filed 5–2–00; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Federal Set-Aside Program; Special

Projects of Regional and National

Significance; Data Utilization and

Enhancement: Cooperative

Agreements for State Information

Systems

AGENCY: Health Resources and Services

Administration, HHS.

ACTION: Notice of availability of funds.

SUMMARY: The Health Resources and

Services Administration (HRSA)

announces that approximately $428,000

in fiscal year (FY) 2000 funds is

available for 6 to 10 cooperative

agreements to improve maternal and

child health State information systems.

All awards will be made under the

program authority of section 502(a) of

the Social Security Act, the Maternal

and Child Health (MCH) Federal SetAside Program (42 U.S.C. 702(a)). This

Data Utilization and Enhancement

(DUE) Cooperative Agreement Program

(CFDA #93.110 U) will be administered

by the Maternal and Child Health

Bureau (MCHB), HRSA. Projects will be

approved for a 3-year period, with

awards at average yearly amounts

ranging from $30,000 to $80,000. Funds

for DUE cooperative agreements are

appropriated by Public Law 106–113.

The DUE competition announced in

this notice is a successor to a similar