[Federal Register Volume 65, Number 197 (Wednesday, October 11, 2000)]
[Notices]
[Pages 60442-60443]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25993]


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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 
known as the Agency for Health Care Policy and Research (AHCPR).

ACTION: Notice of public meeting.

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SUMMARY: 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 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. 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 group 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 Sec. 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 sound clinical trials appropriate 
for Medicare coverage.

DATES: The meeting will take place on October 20, 2000, from 9 a.m.-12 
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-

[[Page 60443]]

0236; Fax: (301) 594-4027; E-mail: [email protected].
    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 costs 
for the investigational item or service itself, data collection-related 
costs, and items and services provided free of charge by the sponsor 
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 group 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 or 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 
multi-agency panel that it has convened, to be of sound quality and to 
have these desirable characteristics. Guided by the assumptions of the 
multi-agency group and discussions with AHRQ, HFCA 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 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 the trial and will not be used to retroactively 
change the earlier deemed status.''
    The Federal multi-agency group 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 Decisions posted on HCFA's website (http://www.hcfa.gov/quality/8d.htm).

2. Purpose

    To gather pertinent information and views that would contribute to 
defining the qualifying criteria used to identify sound clinical trials 
appropriate for Medicare coverage, AHRQ is holding this meeting. We are 
soliciting comments about what qualifying criteria might be appropriate 
and adequate to capture the desirable characteristics of sound clinical 
trials. The criteria should be easily verifiable and, where possible, 
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 any external, non-Federal 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?
    AHRQ is also interested in receiving information on the 
availability of relevant literature (citations or copies if possible) 
that might assist the panel in its formulation of the qualifying 
criteria.

Agenda

    The meeting will begin at 9 a.m. and continue through 12 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.
    Due to time constraints, this Notice is published within the 
recommended 15 days prior to holding this public meeting.

    Dated: October 4, 2000.
John M. Eisenberg,
Director.
[FR Doc. 00-25993 Filed 10-10-00; 8:45 am]
BILLING CODE 4160-90-M