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Notice of Qualifying Clinical Trials Update

In accordance with public notice requirements established at 42 CFR 447.205, the Indiana Family and Social Services Administration (FSSA), Office of Medicaid Policy and Planning (OMPP) publishes this notice of proposed changes to methods and standards governing coordination of benefits cost avoidance policies related to special treatment of certain types of care and payment. The public notice period will run 05/11/2022 through 06/10/2022.

FSSA – OMPP proposes to modify coverage requirements for coverage of routine patient costs associated with participation in qualifying clinical trials.

OMPP is making these changes to comply with Division CC, Title II, Section 210 of the Consolidated Appropriations Act, 2021 (Public Law 116-260) (section 210) amended section 1905(a) of the Social Security Act, by adding to the definition of medical assistance a new benefit at section 1905(a)(30) for routine patient costs for items and services furnished in connection with participation by Medicaid beneficiaries. It is estimated that there will be no fiscal impact of these changes. This change will be effective 6/1/2022.

A copy of this notice is now on file at the Indiana Government Center South, 402 West Washington Street, Room W451 and is open for public inspection. Also, a copy of this notice is now available and may be inspected by contacting the local county Division of Family Resources (DFR) office, except in Marion County, where public inspection may be made at 402 West Washington Street, Room W374, Indianapolis, Indiana.

There will be no public hearing. Written comments may be directed to, FSSA, Office of Medicaid Policy and Planning, Attention: Madison May-Gruthusen, 402 West Washington Street, Room W382, P.O. Box 7083, Indianapolis, IN 46207-7083 or by email to spacomments@fssa.in.gov. Correspondence should be identified in the following manner: COMMENT RE: QUALIFYING CLINICAL TRIALS. Written comments will be made available for public inspection at the address herein of the OMPP.

Daniel Rusyniak, MD
Family and Social Services Administration

Posted: 05/11/2022 by Legislative Services Agency

DIN: 20220511-IR-405220147ONA
Composed: Dec 04,2022 8:01:58PM EST
A PDF version of this document.