After direct advocacy from the Association for Clinical Oncology (ASCO) and its members, in December 2020 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.
In early 2022, 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 early 2023, 47 states and the District of Columbia have an approved SPA. States without an approved SPA include Arkansas, Delaware, and Colorado. ASCO is continuing to collaborate with State Affiliates and outside stakeholders to raise awareness and facilitate implementation of this new coverage requirement.
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