CMS-10398 #74 Qualifying Clinical Trial Preprint (Attachment 3.1-B)

ATTACHMENT 3.1-B
Page 1
CMS - 179
State/Territory: _____________
AMOUNT, DURATION AND SCOPE OF SERVICES PROVIDED
MEDICALLY NEEDY GROUP(S)
30. Coverage of Routine Patient Cost in Qualifying Clinical Trials
*The state needs to check each assurance below.
Provided: _______
I.

General Assurances:

Routine Patient Cost – Section 1905(gg)(1)
___Coverage of routine patient cost for items and services as defined in section 1905(gg)(1) that
are furnished in connection with participation in a qualified clinical trial.
Qualifying Clinical Trial – Section 1905(gg)(2)
___A qualified clinical trial is a clinical trial that meets the definition at section 1905(gg)(2).
Coverage Determination – Section 1905(gg)(3)
___A determination with respect to coverage for an individual participating in a qualified clinical
trial will be made in accordance with section 1905(gg)(3).

TN:_________
Supersedes:
TN:__________

_

Approval Date:________

_ Effective Date _______

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
0938-1148 (CMS-10398 #74). 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.

TN:_________
Supersedes:
TN:__________

_

Approval Date:________

_ Effective Date _______