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January 2023 Issue

MDCSCO Insights

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CALL TO ACTION: Clinical Treatment Act Implementation

Beginning on January 1, 2022, all states and territories will be required to cover and reimburse for the routine costs of care for services associated with Medicaid enrollee participation in a qualifying clinical trial. The Center for Medicaid and CHIP Services (CMCS) issued a State Medicaid Director Letter outlining new Medicaid state plan requirements, including what is/is not a covered service, definition of a qualifying clinical trial, coverage determinations, and state exceptions for compliance as presented in the legislation.

CMCS is instructing states to submit a state plan amendment (SPA) describing coverage, benefits, and payment methodology used to pay service providers for routine costs associated with clinical trials in each state. The SPA should be issued at least one day prior to the effective date of the proposed changes. To ensure equitable, transparent, consistent, and comprehensive coverage requirements across all states, ASCO drafted a SPA offering specific and technical coverage and reimbursement recommendations. The SPA is intended to serve as a model submission from state Medicaid agencies to CMCS. We have also attached an accompanying "challenges" document which provides the rationale for the provisions included in the SPA and other implementation considerations.

We urge State Affiliates to send the attached SPA and challenges document to your State Medicaid Agency requesting they consider our recommendations as they draft their own. With the CLINICAL TREATMENT Act effective in less than two weeks, we recommend sending this as soon as possible. Please contact Gina Hoxie at [email protected] with any questions or for additional information.

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