65318 Federal Register / Vol. 65, No. 212 / Wednesday, November 1, 2000 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Agency for Healthcare Research and

Quality

Public Meeting on Medicare Coverage

of Clinical Trials

AGENCY: Agency for Healthcare Research

and Quality (AHRQ), formerly AHCPR,

DHHS.

ACTION: Notice of public meeting.

SUMMARY: On October 20, 2000, AHRQ

held a public meeting to hear comments

from the public on specific qualifying

criteria for identifying clinical trials

appropriate for Medicare coverage. To

provide additional time for

organizations and institutions interested

in presenting and/or submitting their

comments, AHRQ is holding a second

public meeting on November 20, from 9

a.m. to 1 p.m.

In the past, Medicare has not paid for

health care services provided as part of

clinical trials because of their

experimental nature. To carry out an

executive memorandum from the

President of the United States to the

Secretary of Health and Human

Services, received on June 7, 2000

directing Medicare to promptly provide

for payment of routine patient care costs

incurred by Medicare beneficiaries in

connection with participation in clinical

trials, the Health Care Financing

Administration (HCFA) has issued a

National Coverage Decision. The text of

the NCD is available on the HCFA

website: (http://www.hcfa.gov/quality/

8d2.htm). In order to implement this

new coverage policy for routine costs in

clinical trials, HCFA must define the

clinical trials for which payment of

routine costs would be appropriate.

Therefore, HCFA requested AHRQ to

convene a multi-agency Federal Panel

(the ‘‘Panel’’) to develop readily

verifiable criteria by which to identify

trials that meet an appropriate standard

of quality. The qualifying criteria will be

developed under the authority to

support health care research in § 1142 of

the Social Security Act (Act).

This notice announces a public

meeting for the purpose of receiving oral

and written comments on easily

verifiable qualifying criteria for

identifying clinical trials appropriate for

Medicare coverage. The criteria should

be objective (dichotomous yes/no

answers) and should not require a

detailed and technical expert

assessment of each trial.

DATES: The second public meeting will

take place on November 20, from 9 a.m.

to 1 p.m.

ADDRESSES: The meeting will be held at

the Agency for Healthcare Research and

Quality Conference Center, 6010

Executive Blvd., 4th Floor, Rockville,

MD 20852.

FOR FURTHER INFORMATION CONTACT:

Nilam Patel, M.P.H., Center for Practice

and Technology Assessment, AHRQ,

6010 Executive Blvd., Suite 300,

Rockville, MD 20852; phone: (301) 594–

0236; Fax: (301) 594–4027; E-mail:

npatel@ahrq.gov.

Arrangements for the Public Meeting:

All representatives of organizations and

other individuals who wish to attend,

provide relevant written comments and

information to AHRQ, and/or make a

brief (10 minutes or less) oral statement

at the meeting, must register with Nilam

Patel, AHRQ, at the above address no

later than three days prior to the date of

the meeting. A copy of written materials

should also be submitted to Ms. Patel.

On the day of the meeting, presenters

are requested to bring 25 copies of their

written materials for distribution.

If sign language interpretation or other

reasonable accommodations for a

disability is needed, please contact

Linda Reeves, Assistant Administrator

for Equal Opportunity, AHRQ, at (301)

594–6662 no later than three days before

the meeting date.

SUPPLEMENTARY INFORMATION:

1. Background

In June, 2000, the President of the

United States issued an executive

memorandum directing the Secretary of

Health and Human Resources to

‘‘explicitly authorize Medicare payment

for routine patient care costs * * * and

costs due to medical complications

associated with participation in clinical

trials.’’ In keeping with the President’s

directive, HCFA has developed and

added a new section in the Medicare

Coverage Issues Manual that will

implement national coverage of routine

costs of qualified clinical trials. For the

purposes of this national coverage

decision, routine costs of clinical trials

include all items and services that are

otherwise generally available to

Medicare beneficiaries (conventional

care); for example, hospital services,

physician services, and diagnostic tests

that are not statutorily excluded from

coverage. Certain costs, such as the

investigational item or service, itself,

items and services provided solely to

satisfy data collection and analysis

needs and that are not used in the direct

clinical management of the patient (e.g.,

monthly CT scans for a condition

usually requiring only a single scan),

and items and services customarily

provided by the research sponsors free

of charge for any enrollee in the trial

will not be covered.

In order to implement the coverage

policy, a system must be in place to

help identify trials that meet an

appropriate standard of quality and for

which it is appropriate for Medicare to

pay the associated routine costs. HCFA

requested AHRQ to form a multi-agency

Federal Panel to develop qualifying

criteria that would indicate a high

probability that a trial has the following

desirable characteristics of a

scientifically sound clinical trial:

(1) The principal purpose of the trial

is to test whether the intervention

potentially improves the participants’

health outcomes;

(2) The trial is well-supported by

available scientific and medical

information or it is intended to clarify

to establish the health outcomes of

interventions already in common

clinical use;

(3) The trial does not unjustifiably

duplicate existing studies;

(4) The trial design is appropriate to

answer the research question being

asked in the trial;

(5) The trial is sponsored by a credible

organization or conducted by an

individual capable of executing the

proposed trial successfully;

(6) The trial is in compliance with

Federal regulations relating to the

protection of human subjects; and

(7) The trial is conducted according to

appropriate standards of scientific

integrity.

Certain trials are presumed by AHRQ,

and the other members of the Panel that

it has convened, to be of sound quality

and to have these desirable

characteristics. Guided by the

assumptions of the Panel and

discussions with AHRQ, HCFA

announced both long term and short

term types of automatic qualification for

Medicare coverage of the routine costs

of clinical trials in its related NCD.

‘‘Effective September 19, 2000,

clinical trials that are deemed to be

automatically qualified are:

1. Trials funded by NIH, CDC, AHRQ,

HCFA, DOD, and VA;

2. Trials supported by centers or

cooperative groups that are funded by

the NIH, CDC, AHRQ, HCFA, DOD and

VA;

3. Trials conducted under an

investigational new drug application

(IND) reviewed by the FDA; and

4. Drug trials that are exempt from

having an IND under 21 CFR 312.2(b)(1)

will be deemed automatically qualified

until the qualifying criteria are

developed and the certification process

is in place. At that time the principal

investigators of these trials must certify

Federal Register / Vol. 65, No. 212 / Wednesday, November 1, 2000 / Notices 65319

that the trials meet the qualifying

criteria in order to maintain Medicare

coverage of routine costs. This

certification process will only affect the

future status of a trial and will not be

used to retroactively change the earlier

deemed status.’’

The Panel will be developing criteria

for identifying other trials that are likely

to have the seven desirable

characteristics of clinical trials. (From

HCFA’s Final National Coverage

Decision posted on HCFA’s website

(http://www.hcfa.gov/quality/8d2.htm).

2. Purpose

AHRQ is holding this second meeting

to ensure that all interested parties have

adequate time to provide comments and

pertinent information that would

contribute to defining specific and

unambiguous qualifying criteria for

identifying clinical trials appropriate for

Medicare coverage. We are soliciting

comments about what specific

qualifying criteria might be used to

select trials that are likely to have the

desirable characteristics of scientifically

sound clinical trials identified by

HCFA. The criteria should be easily

verifiable, should not require a detailed

and expert trial by trial review, and,

where possible, be dichotomous (that is,

objective yes/no responses). Some

examples might be:

Is the trial approved by an

investigational review board (IRB)?

Does the trial have a written protocol?

Has the trial been approved by a Federal

agency?

Has the trial received and external, nonFederal funding?

Has the trial been reviewed by any

external, non-Federal group?

Does a data safety and monitoring board

provide independent oversight of the

trial?

AGRQ is also interested in receiving

information on the availability of

relevant literature (citations or copies if

possible) that might assist the Panel in

its formation of the qualifying criteria.

Agenda

The meeting will begin at 9 a.m. and

continue through 1 p.m. If more

requests to make oral statements are

received than can be accommodated at

this meeting, the chair person will

allocate speaking time in a manner that

attempts, to the extent possible, to have

a range of information, findings, and

views presented orally. Those who

cannot be granted speaking time

because of time constraints are assured

that their written comments will be

considered along with other evidence

during the course of further discussions

and report preparation.

Dated: October 26, 2000.

John M. Eisenberg,

Director.

[FR Doc. 00–28036 Filed 10–31–00; 8:45 am]

BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention (CDC)

The Advisory Committee to the

Director, National Center for

Environmental Health (NCEH), Centers

for Disease Control and Prevention

(CDC); Meeting.

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Pub.L. 92–463), the Centers for Disease

Control and Prevention (CDC)

announces the following committee

meeting:

Name: Advisory Committee to the Director,

NCEH.

Times and Dates: 9 am–5 pm (EST),

November 20, 2000; 9 am–12 pm (EST),

November 21, 2000.

Place: Swissotel, 3391 Peachtree Road, NE,

Atlanta, GA 30326.

Status: Open to the public for observation

and comment, limited only by the space

available. The meeting room accommodates

approximately 45 people.

Purpose: The Secretary, and by delegation,

the Director, Centers for Disease Control and

Prevention, are authorized under Section

301(42 U.S.C. 241) and Section 311(42 U.S.C.

243) of the Public Health Service Act, as

amended, to (1) conduct, encourage,

cooperate with, and assist other appropriate

public authorities, scientific institutions, and

scientists in the conduct of research,

investigations, experiments, demonstrations,

and studies relating to the causes, diagnosis,

treatment, control, and prevention of

physical and mental diseases, and other

impairments; (2) assist States and their

political subdivisions in the prevention of

infectious diseases and other preventable

conditions, and in the promotion of health

and well being; and (3) train State and local

personnel in health work. The purpose of

this meeting is to provide advice on: (1)

Environmental public health problems that

potentially pose the greatest risks to human

health and may not be receiving adequate

attention; (2) the primary prevention of birth

defects and developmental and other

disabilities; (3) the prevention of secondary

conditions in persons with a primary

disability; and (4) the research agenda

needed to improve the science base relative

to human health effects and environmental

exposures, and that will ultimately provide

sound human health data for policy and

decision-making.

Matters to be Discussed: Agenda items will

include implications of the Child Health Bill,

the National Exposure Report, the Genetics

Assessment Testing Program, and on a shared

vision of environmental health between

NCEH and the Agency for Toxic Substances

and Disease Registry (ATSDR) at CDC.

Agenda items are tentative and subject to

change as priorities dictate.

Contact Person for more Information:

Michael J. Sage, Designated Federal Official,

CDC, 4770 Buford Highway, NE, MS F–29,

Atlanta, Georgia 30341–3724; telephone 770–

488–7020, fax 770–488–7024; e-mail:

mjs6@cdc.gov.

The Director, Management Analysis and

Services Office, has been delegated the

authority to sign Federal Register notices

pertaining to announcements of meetings and

other committee management activities for

both the Centers for Disease Control and

Prevention and the Agency for Toxic

Substances and Disease Registry.

Dated: October 27, 2000.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention.

[FR Doc. 00–27986 Filed 10–31–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

[Program Announcement No. ACF/ACYF–

PA–HS–2001–02B]

Fiscal Year 2001 Discretionary

Announcement for Select Service

Areas of Early Head Start; Availability

of Funds and Request for Applications

AGENCY: Administration on Children,

Youth and Families, ACF, DHHS.

ACTION: Correction.

SUMMARY: This document contains a

correction to the Notice that was

published in the Federal Register on

Wednesday, September 13, 2000.

On page 55256, in the State of Alaska,

in the Funding for the following

counties column, delete ‘‘$797,487’’ and

replace with ‘‘$914,488’’.

On page 55256, in the State of

Arizona, in the County of Maricopa, in

the Funding for the following counties

column, delete ‘‘$895,843’’ and replace

with ‘‘$956,190’’.

On page 55256, in the State of

California, add ‘‘Alameda’’ to the

County column, and next to that add

‘‘$1,254,931’’ in the Funding for the

following counties column, and in the

Current service area column add ‘‘San

Leandro, San Lorenzo, Castro Valley,

Hayward, Union City, Fremont, Newark,

Livermore, Pleasanton, and Dublin’’.

On page 55256, in the State of

California, in the County of El Dorado,

in the Funding for the following

counties column, delete ‘‘884,818’’ and

replace with ‘‘$947,640’’.