Implementation of CLINICAL TREATMENT Act Advances, Increasing Access to Cancer Clinical Trials

Nine states still need to submit coverage and benefit plan to CMCS
June 21, 2022

After direct advocacy from the Association for Clinical Oncology (ASCO) and its members, in December 2019 Congress enacted the CLINICAL TREATMENT Act, which requires all states and territories to cover and reimburse routine costs of care for treating a Medicaid enrollee who is participating in a qualifying clinical trial. Routine costs of care include any item or service provided to prevent, diagnose, monitor, or treat complications resulting from participation in the qualifying clinical trial, such as the cost of physician visits or laboratory tests. The cost of any investigative device or drug will continue to be covered by the trial sponsor. The law, which went into effect on January 1, 2022, brings much needed coverage and access to clinical trials to more than 42 million Medicaid patients.

ASCO is continuing to collaborate with State Affiliates and outside stakeholders to raise awareness and facilitate implementation of this new coverage requirement.

Earlier this year, the Center for Medicaid and CHIP Services (CMCS) issued a State Medicaid Director Letter (SMDL) outlining new Medicaid state plan requirements. The letter requires all states – even those that previously covered routine costs – to submit a state plan amendment (SPA) to CMCS for approval. The SPA must outline each state’s coverage and benefit policies and must comply with the SMDL. 

As of June 29, 2022, 41 states and the District of Columbia have an approved SPA. States without an approved SPA include: Arkansas, Delaware, Kentucky, New York, South Carolina, Wyoming, California, Colorado, and Minnesota. ASCO members in states without an approved SPA should contact their State Medicaid Director. ASCO is also reaching out to states that have not yet submitted a SPA to CMCS and is encouraging them to do so.

Bookmark ASCO in Action to stay up-to-date on implementation of the CLINICAL TREATMENT Act and ASCO’s work to improve access to clinical trials.