[Federal Register Volume 65, Number 212 (Wednesday, November 1, 2000)]
[Notices]
[Pages 65318-65319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-28036]



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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 
AHCPR, DHHS.

ACTION: Notice of public meeting.

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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 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 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: [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 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

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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, 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?

    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