HHS Qualifying Clinical Trial Attestation Form

[Medicaid] Generic Clearance for Medicaid and CHIP State Plan, Waiver, and Program Submissions (CMS-10398)

REVISED QUALIFYING CLINICAL TRIAL ATTESTATION FORM Clean 3.17.22 - 508

GenIC #74 (Revised): Coverage of Routine Patient Cost for Items & Services in Qualifying Clinical Trials

OMB: 0938-1148

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MEDICAID ATTESTATION FORM ON THE
APPROPRIATENESS OF THE QUALIFIED CLINICAL TRIAL
Participant
Participant Name: ___________________________________
Medicaid I.D.: ___________________________________
Qualified Clinical Trial
National Clinical Trial Number (from clinicaltrials.gov): _______________________________________
Principal Investigator Attestation
Principal Investigator Name: __________________________________________________
 I hereby attest to the appropriateness of the qualified clinical trial in which the individual identified

above is participating.

 The Principal Investigator is also the Health Care Provider and hereby attests to the appropriateness of
the qualified clinical trial in which the individual identified above is participating.
Signature: _________________________________________ Date: _____________________________
(signature of principal investigator)
(month, day, year)

Health Care Provider Attestation
Health Care Provider Name: __________________________________________________
 I hereby attest to the appropriateness of the qualified clinical trial in which the individual identified

above is participating.

Signature: __________________________________________ Date: ___________________________
(signature of health care provider)
(month, day, year)

PRA Disclosure Statement - This information is being collected to assist the Centers for Medicare & Medicaid Services in implementing Section
210 of the Consolidated Appropriations Act of 2021 amending section 1905(a) of the Social Security Act (the Act), by adding a new mandatory
benefit at section 1905(a)(30). Section 210 mandates coverage of routine patient services and costs furnished in connection with participation by
Medicaid beneficiaries in qualifying clinical trials effective January 1, 2022. Section 210 also amended sections 1902(a)(10)(A) and 1937(b)(5) of
the Act to make coverage of this new benefit mandatory under the state plan and any benchmark or benchmark equivalent coverage (also referred
to as alternative benefit plans, or ABPs). Under the Privacy Act of 1974 any personally identifying information obtained will be kept private to
the extent of the law. An agency may notconduct or sponsor, and a person is not required to respond to, a collection of information unlessit displays
a currently valid Office of Management and Budget (OMB) control number. The OMB control number for this project is 0938-0193. Public
burden for all of the collection of information requirements under this control number is estimated to take about 56 hours per response. Send
comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to CMS,
7500 SecurityBoulevard, Attn: Paperwork Reduction Act Reports Clearance Officer, Mail Stop C4-26-05, Baltimore, Maryland 21244-1850.


File Typeapplication/pdf
AuthorFrances Crystal
File Modified2022-03-29
File Created2022-03-29

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