Federal Register / Vol. 66, No. 124 / Wednesday, June 27, 2001 / Notices 34223

minimize the information collection

burden.

Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: CLIA Budget

Workload Reports and Supporting

Regulations in 42 CFR 493.1–.2001;

Form No.: HCFA–102/105 (OMB#0938–

0599); Use: This information will be

used by HCFA to determine the amount

of Federal reimbursement for

compliance surveys. In addition, the

HCFA 102/105 is used for program

evaluation, budget formulation and

budget approval.; Frequency: Quarterly

and Annually; Affected Public: State,

local or tribal government; Number of

Respondents: 50; Total Annual

Responses: 50; Total Annual Hours:

4,500.

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, OMB number, and HCFA

document identifier, 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 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following

address:HCFA, Office of Information

Services, Information Technology

Investment Management Group,

Division of HCFA Enterprise

Standards,Attention: Julie Brown,

HCFA–102/105,Room N2–14–26,7500

Security BoulevardBaltimore, Maryland

21244–1850.

Dated: June 18, 2001.

John P. Burke, III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services,Information

Technology Investment Management Group,

Division of HCFA Enterprise Standards.

[FR Doc. 01–16140 Filed 6–26–01; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–10035]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

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, has submitted to the

Office of Management and Budget

(OMB) the following proposal for the

collection of information. Interested

persons are invited to send comments

regarding the 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.

Type of Information Collection

Request: New Collection;

Title of Information Collection:

Collection of Data on Quality Indicators

for Congestive Heart Failure Submitted

by Medicare+Choice Organizations

Requesting Extra Payments in CY2002

and CY2003 and Supporting

Regulations in 42 CFR, 422.152(b)(2);

Form No.: HCFA–10035 (OMB# 0938–

NEW);

Use: HCFA requires Congestive Heart

Failure (CHF) quality indicator

performance data from qualifying

Medicare+Choice organizations opting

to receive extra payments for CY2002

and CY2003. This collection will collect

the necessary data to assess the need for

extra payments.;

Frequency: Annually;

Affected Public: Business or other forprofit, and Not-for-profit institutions;

Number of Respondents: 125;

Total Annual Responses: 125;

Total Annual Hours: 11.

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, DC 20503.

Dated: June 5, 2001.

John P. Burke, III,

HCFA Reports Clearance Officer, HCFA,

Office of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 01–16138 Filed 6–26–01; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–3072–PN]

Medicare Program; Application by the

American Diabetes Association (ADA)

for Recognition as a National

Accreditation Program for Accrediting

Entities to Furnish Outpatient Diabetes

Self-Management Training

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Proposed notice.

SUMMARY: In this proposed notice, we

announce the receipt of an application

from the American Diabetes Association

(ADA) for recognition as a national

accreditation program for accrediting

entities that wish to furnish outpatient

diabetes self-management training to

Medicare beneficiaries. Section

1865(b)(3) of the Social Security Act

requires that the Secretary publish a

notice identifying the national

accreditation body making the request,

describing the nature of the request, and

providing at least a 30-day public

comment period.

DATES: We will consider comments if

we receive them at the appropriate

address, as provided below, no later

than 5 p.m. on July 27, 2001.

ADDRESSES: In commenting, please refer

to file code HCFA–3072–PN. Because of

staff and resource limitations, we cannot

accept comments by facsimile (FAX)

transmission. Mail written comments

(one original and three copies) to the

following address ONLY: Health Care

Financing Administration, Department

of Health and Human Services,

Attention: HCFA–3072–PN, P.O. Box

8016, Baltimore, MD 21244–8016.

Please allow sufficient time for mailed

comments to be timely received in the

event of delivery delays.

If you prefer, you may deliver (by

hand or courier) your written comments

(one original and three copies) to one of

the following addresses: Room 443–G,

Hubert H. Humphrey Building, 200

Independence Avenue, SW.,

Washington, DC 20201, or Room C5–16–

03, 7500 Security Boulevard, Baltimore,

MD 21244–1850.

34224 Federal Register / Vol. 66, No. 124 / Wednesday, June 27, 2001 / Notices

Comments mailed to the above

addresses may be delayed and received

too later for us to consider them.

For information on viewing public

comments, see the beginning of the

SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Joan

A. Brooks, (410) 786–5526.

SUPPLEMENTARY INFORMATION:

Inspection of Public Comments:

Comments received timely will be

available for public inspection as they

are received, generally beginning

approximately 3 weeks after publication

of a document, at the headquarters of

the Health Care Financing

Administration, 7500 Security

Boulevard, Baltimore, Maryland 21244,

Monday through Friday of each week

from 8:30 a.m. to 4 p.m. To schedule an

appointment to view public comments,

phone (410) 786–7195 or (410) 786–

5241.

I. Background

Under the Medicare program, eligible

beneficiaries may receive outpatient

diabetes self-management training when

ordered by the physician (or qualified

nonphysician practitioner) treating the

beneficiary’s diabetes, provided certain

requirements are met. We sometimes

use national accrediting organizations to

determine whether an entity meets some

or all of the requirements that are

necessary to provide a service for which

Medicare payment can be made.

Accreditation is authorized by section

1865 of the Social Security Act (the Act)

and our regulations in 42 CFR part 410,

subpart H.

Under section 1865(b)(1) of the Act, a

national accreditation organization must

have an agreement in effect with the

Secretary and meet the standards and

requirements specified by the Secretary

in part 410, subpart H. The regulations

pertaining to application procedures for

national accreditation organizations for

diabetes self-management training

services are at § 410.142 (HCFA process

for approving national accreditation

organizations). A national accreditation

organization applying for deeming

authority must provide us with

reasonable assurance that the

accrediting organization requires

accredited entities to meet requirements

that are at least as stringent as HCFA’s.

We may approve and recognize a

nonprofit or not-for-profit organization

with demonstrated experience in

representing the interests of individuals

with diabetes to accredit entities to

furnish training. The accreditation

organization, after being approved and

recognized by HCFA, may accredit an

entity to meet one of the sets of quality

standards in § 410.144 (Quality

standards for deemed entities).

Section 1865(b)(1) of the Act,

provides that if the Secretary finds that

accreditation of an entity by a national

accreditation body demonstrates that all

of the applicable conditions and

requirements are met or exceeded, the

Secretary shall deem those entities as

meeting the applicable Medicare

requirements. Section 1865(b)(2) of the

Act further requires that the Secretary’s

findings consider the applying

accreditation organization’s

requirements for accreditation, its

survey procedures, its ability to provide

adequate resources for conducting

required surveys and its ability to

supply information for use in

enforcement activities, its monitoring

procedures for entities found out of

compliance with the conditions or

requirements, and its ability to provide

the Secretary with necessary data for

validation. The Secretary then examines

the national accreditation organization’s

accreditation requirements to determine

if they meet or exceed the Medicare

conditions as we would have applied

them. Section 1865(b)(3)(A) of the Act

requires that the Secretary publish

within 60 days of receipt of a completed

application, a notice identifying the

national accreditation body making the

request, describing the nature of the

request, and providing at least a 30-day

public comment period. In addition, the

Secretary has 210 days from receipt of

the request to publish a finding of

approval or denial of the application. If

the Secretary recognizes an

accreditation organization in this

manner, any entity accredited by the

national accreditation body’s HCFAapproved program for that service will

be ‘‘deemed’’ to meet the Medicare

conditions of coverage.

II. Purpose

The purpose of this notice is to notify

the public of the American Diabetes

Association’s (ADA’s) request for the

Secretary’s approval of its accreditation

program for outpatient diabetes selfmanagement training services. This

notice also solicits public comments on

the ability of the ADA to develop and

apply its standards to entities furnishing

outpatient diabetes self-management

training services that meet or exceed the

Medicare conditions for coverage.

III. Outpatient Diabetes SelfManagement Training Services

Conditions for Coverage and

Requirements

The regulations specifying the

Medicare conditions for coverage for

outpatient diabetes self-management

training services are located in 42 CFR

part 410, subpart H. These conditions

implement section 1861(qq) of the Act,

which provides for Medicare Part B

coverage of outpatient diabetes selfmanagement training services specified

by the Secretary.

Under section 1865(b)(2) of the Act

and our regulations at §§ 410.142 (HCFA

process for approving national

accreditation organizations) and 410.143

(Requirements for approved

accreditation organizations), we review

and evaluate a national accreditation

organization based on (but not

necessarily limited to) the criteria set

forth in § 410.142(b).

We may visit the prospective

organization’s offices to verify

information in the organization’s

application, including, but not limited

to, review of documents, and interviews

with the organization’s staff. We may

conduct onsite inspection of a national

accreditation organization’s operations

and office to verify information and

assess the organization’s compliance

with its own policies and procedures.

The onsite inspection may include, but

is not limited to, reviewing documents,

auditing documentation of meetings

concerning the accreditation process,

evaluating accreditation results or the

accreditation status decisionmaking

process, and interviewing the

organization’s staff.

IV. Notice Upon Completion of

Evaluation

Upon completion of our evaluation,

including evaluation of comments

received as a result of this notice, we

will publish a notice in the Federal

Register announcing the result of our

evaluation.

V. Responses to Public Comments

Because of the large number of

comments we normally receive on

Federal Register documents published

for comment, we are not able to

acknowledge or respond to them

individually. We will consider all

comments we receive by the date and

time specified in the DATES section of

this notice and will respond to them in

a forthcoming rulemaking document.

In accordance with the provisions of

Executive Order 12866, the Office of

Management and Budget did not review

this notice.

Authority: Section 1865 of the Social

Security Act (42 U.S.C. 1395bb).

(Catalog of Federal Domestic Assistance

Program No. 93.773 Medicare-Hospital

Insurance Program; and No. 93.774,

Medicare-Supplementary Medical

Insurance Program)

Federal Register / Vol. 66, No. 124 / Wednesday, June 27, 2001 / Notices 34225

Dated: June 17, 2001.

Thomas A. Scully, Administrator,

Health Care Financing Administration.

[FR Doc. 01–16025 Filed 6–26–01; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Notice of a Cooperative Agreement to

Develop and Manage a Program for

Faculty Leadership in Interdisciplinary

Education to Promote Patient Safety

(FLIEPPS)

The Health Resources and Services

Administration (HRSA) announces that

applications will be accepted for a

Cooperative Agreement for fiscal year

(FY) 2001 to Develop and Manage a

Program for Faculty Leadership in

Interdisciplinary Education to Promote

Patient Safety (FLIEPPS).

The purpose of this Cooperative

Agreement is to develop a ‘‘train the

trainers’’ program to create nurse and

physician faculty leaders in

interdisciplinary education specifically

directed toward enhancing patient

safety. Graduates of the program could

then lead in the training of other faculty

in curricula and techniques in

interdisciplinary education to promote

patient safety. The ultimate goal of this

program is to bridge the separate

cultures of practice in medicine and

nursing by expanding numbers of

professionals who are trained to work

together in teams to improve systems for

safe patient care and to prevent errors.

Authorizing Legislation

This Cooperative Agreement is

solicited under the following authorities

of titles VII and VIII of the Public Health

Service (PHS) Act: (1) Section 747, as

amended, which authorizes grants for

training of physicians who plan to teach

in training programs for primary care

medicine (family medicine, general

internal medicine, general pediatrics,

and/or geriatrics); and (2) section 811, as

amended, which authorizes grants to

strengthen programs that enhance

advanced nurse education and practice.

The Federal role in the conduct of this

Cooperative Agreement is substantial

and will be maintained by the Bureau of

Health Professions (BHPr) staff through

technical assistance and guidance to the

awardee considerably beyond the

normal stewardship responsibilities in

the administration of grant awards. This

Federal role may include any or all of

the following:

(a) Technical assistance and

participation in the planning,

development, and implementation of all

phases of the program, including

consultation about contracts and

agreements developed during the

implementation of the program, all

curricula developed for the program,

content and staffing of training

workshops, and the development of an

evaluation plan for the project which

would be initiated at its inception;

(b) Assistance with identification of

Federal and other organizations with

whom collaboration is essential in order

to further the Cooperative Agreement

mission and to develop specific

strategies to support the work of these

related activities;

(c) Participation in the development

of funding projections;

(d) Participation in the development

of data collection systems and

procedures;

(e) Participation in appropriate

meetings, committees, subcommittees,

and working groups related to the

Cooperative Agreement and its projects

as well as site visits.

The successful applicants will be

included in the overall program

activities of the Department of Health

and Human Services (HHS) in patient

safety and will participate in the

programs and support services that will

be offered by the Patient Safety Research

Coordinating Center supported under a

contract from the Agency for Healthcare

Research and Quality (AHRQ). The

Cooperative Agreements are part of an

overall HHS funding effort to improve

patient safety research, demonstration

and education through a series of RFAs

and Cooperative Agreements (related

RFAs are listed at www.ahrq.gov,

particularly the AHRQ Patient Safety

Research Dissemination and Education

RFA that was published on April 23,

2001).

Availability of Funds

Up to $400,000 will be available in FY

2001 to fund one award for the first

year. Funding may be continued to

complete a 3-year total project period. It

is expected that the award will be made

on or before September 30, 2001.

Support beyond the first year of the

project period will be based on the

achievement of satisfactory progress and

the availability of funds.

Background

In September 2000, shortly after the

Institute of Medicine (IOM) published

its widely discussed report: ‘‘To Err is

Human: Building a Safer Health

System’’ (Kohn, Corrigan and

Donaldson, National Academy Press,

Washington, DC, 2000), the Council on

Graduate Medical Education (COGME)

and the National Advisory Council on

Nurse Education and Practice

(NACNEP) jointly focused on nursephysician collaboration in a report

entitled, ‘‘Collaborative Education

Models to Ensure Patient Safety.’’

COGME–NACNEP joint

recommendations stressed the need for

changing the norms of professional

education and practice so that

physicians and nurses would function

as part of collaborative teams to improve

patient safety and the overall quality of

care. COGME and NACNEP are charged

with advising and reporting to the

Secretary of HHS and the Congress on

workforce, education, and practice

improvement policies.

These joint Advisory Council

recommendations highlighted the

critical importance of developing

educational leaders in interdisciplinary

education to promote patient safety to

effect positive changes toward

developing systems of care that stress

professional collaboration and

teamwork.

This Cooperative Agreement requests

the planning, development, and

implementation of interdisciplinary

educational and training programs for

the education of physicians and nurses

directed toward improving patient

safety. This will involve the

development of formal curricula in

interdisciplinary leadership and

training in interdisciplinary teamwork

focused on building safer systems of

patient care. Curricula must include

both didactic and experiential learning

(in both simulations and practice

settings) with each team being

supported by a mentor. In particular,

safety issues must target those areas of

care which require physician-nurse

communication, especially recognition

and elimination of situations which

create discontinuities in communication

and apparent responsibilities that may

increase the likelihood of errors.

Curricula must contain elements that

emphasize cultural competency, to

broaden physicians’ and nurses’

understanding of how differences in

race, ethnicity, language, gender, and

sexual orientation may affect

communication between physicians,

nurses, and patients, interpretations of

patients’ histories and responses to

recommendations and, thereby, affect

patient safety.

Educational efforts will be directed at

teams of faculty sponsored by health

care organizations (universities,

teaching hospitals, ambulatory centers

or consortia involved in training). Each

team to be trained must include at least