Qualifying Clinical Trial Attestation Form

APPROPRIATENESS OF THE QUALIFYING CLINICAL TRIAL
Section 210 of the Consolidated Appropriations Act of 2021 amended section 1905(a) of the
Social Security Act (the Act), by adding a new mandatory benefit at section 1905(a)(30):
coverage of routine patient services and costs furnished in connection with participation by
Medicaid beneficiaries in qualifying clinical trials. In addition, section 1902(a)(10)(A) of the
Act was amended to add coverage of services and costs provided in connection with qualified
clinical trials to the list of required services. Section 1937(b)(5) of the Act was also amended to
make it mandatory for benchmark benefit plans and benchmark equivalent plans, also known as
Alternative Benefit Plans, to cover routine patient services and costs furnished in connection
with Medicaid beneficiaries who are participating in qualifying clinical trials.
A “qualifying clinical trial” is a clinical trial in any clinical phase of development that is
conducted in relation to the prevention, detection, or treatment of any serious or life-threatening
disease or condition as described in section 1905(a)(30)(i) of the Act, and the study or
investigation is approved, conducted or supported by one or more of the following:
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The National Institutes of Health (NIH);
The Centers for Disease Control and Prevention (CDC);
The Agency for Health Care Research and Quality (AHRQ);
The Centers for Medicare & Medicaid Services (CMS);
A cooperative group or center of any of the entities described above or the Department of
Defense or the Department of Veterans Affairs;
A qualified non-governmental research entity identified in the guidelines issued by the
NIH for center support grants; or
If comparable to the system of peer review studies and investigations used by the
National Institute of Health, and assures unbiased review of the highest scientific
standards by qualified individuals with no interest in the outcome of the review:
o The Department of Energy
o The Department of Veterans Affairs
o The Department of Defense

Also considered qualified is a clinical trial conducted on an investigational new drug that is
exempted under section 505(i) of the Federal Food, Drug, and Cosmetic Act, a biological
product undergoing investigation under section 351(a)(3) of the Public Health Service Act, or a
drug trial that is exempt from being required to have an exemption in section 505(i) of the
Federal Food, Drug and Cosmetic Act or section 351(a)(3) of the Public Health Service Act.
Information regarding qualifying clinical trials is publicly available on a website maintained by
the Secretary, at clinicaltrials.gov and/or can be accessed at (principle investigator provides
link).
In order for a Medicaid beneficiary to receive coverage of routine patient services and costs

furnished in connection with participation in qualifying clinical trials, the principle investigator
of the clinical trial and the participant’s health care provider must attest that the clinical trial

meets the requirements of a federally sponsored clinical trial and is appropriate for the Medicaid
beneficiary.
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PRINCIPLE INVESTIGATOR ATTESTATION

I, __________________________________________________ principle investigator of the qualifying
clinical trial _____________________________________________________________________
(name/subject of qualified clinical trial),
do hereby attest to the appropriateness of the clinical trial in which
_________________________________________________ _____________________________
(name of Medicaid beneficiary)
(participant Medicaid I.D.)
is participating, and that the clinical trial meets the requirements of a federally sponsored clinical trial.
This qualifying clinical trial may be accessed at___________________________________________
(link to the qualified clinical trial)
Signature: _________________________________________ Date: _____________________________
(signature of principle investigator)
(month, day, year)
Physician NPI: _______________________
(if applicable)
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HEALTH CARE PROVIDER ATTESTATION

I, __________________________________________________ health care provider for the clinical trial
participant, _________________________________________________ _______________________
(name of participant),
(participant Medicaid I.D.)
do hereby attest that it is appropriate for __________________________________________________
(name of participant),
a Medicaid beneficiary, to participate in the above named qualified clinical trial and that in accordance
with section 1905(a)(30) of the Act, the beneficiary is entitled to receive coverage of routine patient
services and costs furnished in connection with participation in a qualifying clinical trial.
Signature: __________________________________________ Date: ___________________________
(name of health care provider)
(month, day, year)
Physician NPI: _______________________
Information regarding this qualifying clinical trial that is publicly available on a website maintained by
the Secretary of the Department of Health and Human Services may optionally be provided as an
attachment to this form; however, coverage determinations shall not require submission of the protocols
of the qualifying clinical trial or any other documentation that may be proprietary or determined by the
Secretary to be burdensome.