The AACI-endorsed CLINICAL TREATMENT Act, which took effect January 1, 2022, 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. While the law brings needed coverage and access to clinical trials to more than 42 million Medicaid patients, some states have yet to finalize implementation plans.
The routine care costs included are 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. Trial sponsors will continue to cover the costs of any investigative device or drug.
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.
According to ASCO, as of June 29, 2022, nine states are still without an approved SPA: Arkansas, Delaware, Kentucky, New York, South Carolina, California, Colorado, and Minnesota. AACI encourages centers in those states or who have patients in the catchment areas of those states to urge their State Medicaid Director to finalize their plan.