Medicare Coverage of Clinical
Trials
The NCD calls for coverage of the “routine costs of
qualifying clinical trials.” Clinical trials that are
eligible for Medicare covered must meet three requirements:
(1) the subject or purpose of the trial must be the evaluation
of an item or service that falls within a Medicare benefit
category and is not statutorily excluded from coverage; (2)
the trial must have therapeutic intent; and (3) trials of
therapeutic interventions must enroll patients with diagnosed
disease rather than healthy volunteers; trials of diagnostic
interventions may enroll healthy patients in order to have
a proper control group.
In addition to these three criteria, a qualifying trial must
have “desirable characteristics.” Trials deemed
to be automatically qualified for coverage are: (1) trials
funded by NIH, CDC, AHRQ, CMS, DOD and VA; (2) trials supported
by centers or cooperative groups funded by the federal agencies
listed in 1.; (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, until other qualifying
criteria rare in place. The Agency for Healthcare Research
and Quality (AHRQ) was charged with developing qualifying
criteria for “non-deemed” trials. Two public meetings
were held in the fall of 2000 to solicit ideas about what
should be included in the criteria. The AAMC provided comments.
No criteria have yet been published.
Coverage for costs related to the use of investigational
devices continues to be governed by the regulation found at
42 CFR §405.201-215.
An April 2001 CMS memorandum from the Office of Inspector
General addressed two questions related to the NCD. The memorandum
raised the possibility that the OIG could find that the waivers
of copayments and deductibles—other than for financial
need—or the provision of free items or services to Medicare
beneficiaries enrolled in clinical trials, violate the antikickback
statute or other laws.
Contact
Ivy Baer, Director & Regulatory Counsel
AAMC Health Care Affairs
ibaer@aamc.orc
(202) 828-0490
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