Medicaid Implements Waivers for Some Clinical Trial Coverage

Jan. 4, 2022 / David Raths

Effective Jan. 1, 2022, Clinical Treatment Act expands clinical trial access to more than 41.6 million Medicaid beneficiaries

A federal law that went into effect on Jan. 1, 2022, requires all states and territories to cover and reimburse for the routine costs of care for services associated with Medicaid enrollee participation in a qualifying clinical trial.

Medicaid insures nearly one-fifth of the U.S. population, yet it was the only major payer not required by federal law to provide coverage for routine costs of participation in a clinical trial.

Cancer advocacy organizations have stressed that access to clinical trials provide individuals with cancer with their best clinical option, and in addition, increasing diversity in clinical trials participation improves the validity of research results.

In 2020, Congress passed the Clinical Treatment Act. At the time, the Association for Clinical Oncology (ASCO) called it a giant step forward to reduce health disparities by expanding clinical trial access to more than 41.6 million Medicaid beneficiaries. “We commend Congress for passing this commonsense fix to increase the diversity of participants in clinical trials, improve the validity of clinical research, and help reduce disparities in treatment outcomes for people with life-threatening diseases—disparities that have only been magnified by the COVID-19 pandemic,” ASCO wrote.

In December 2021, the Center for Medicaid and CHIP Services (CMCS) issued a State Medicaid Director Letter outlining new Medicaid state plan requirements, including what is and is not a covered service, definition of a qualifying clinical trial, coverage determinations, and state exceptions for compliance.

CMCS is instructing states to submit a state plan amendment (SPA) outlining the state’s coverage and benefit policies and another to describe payment methodologies that will be used to pay service providers. Because some states may need to act legislatively to implement the new requirements, the guidance also includes language describing the timing of state legislative sessions and applications for delay.

ASCO said it is working closely with its State Affiliates to ensure consistent, transparent, and equitable access to routine care across all states and territories.