On January 1, 2022, the new Medicaid research coverage regulation went into effect. The rule is part of the H.R. 133 - The Consolidated Appropriations Act. The Medicaid research coverage information is found in SEC. 210. PROMOTING ACCESS TO LIFE-SAVING THERAPIES FOR MEDICAID ENROLLEES BY ENSURING COVERAGE OF ROUTINE PATIENT COSTS FOR ITEMS AND SERVICES FURNISHED IN CONNECTION WITH PARTICIPATION IN QUALIFYING CLINICAL TRIALS. The rule requires each state Medicaid to cover certain costs associated with certain clinical trials. See for a more detailed overview of the specific requirements and potential operational challenges. The New Medicaid Clinical Research Coverage Regulation: What you Need to Know and Do Now, Sarah Couture (ankura.com) for a more detailed overview of the specific requirements and potential operational challenges.

While most states have now amended their state plans to cover required clinical research services, very few state Medicaid plans have provided guidance to provider organizations regarding operationalizing the rule, including instructions for submitting the required attestation form (medicaid-attest-form.docx (live.com)). Other questions abound from providers related to the rule itself. In their State Plan Amendments (SPA), states could have clarified certain terms or coverage approaches, but most have adopted the language of the rule itself which poses significant questions:

• What constitutes a “serious or life-threatening” disease or condition?
• Is conventional care covered similar to Medicare coverage (per NCD 310.1)?
• How is the rule applied to device studies?

As states finalize their SPAs and state Medicaids develop their specific approaches for the attestation and other compliance expectations, provider organizations continue to struggle with the lack of clarity and subsequent challenges in operationalizing the requirements. We continue to recommend the following:

• Stay informed as state Medicaid plans develop and roll out their approaches, including reaching out to those plans for advice on the process
• Advocate with state legislatures regarding challenges and concerns that may be impacting patients or the organization
• Continue doing a Medicare-based coverage analysis, then overlay Medicaid specifics
• Continue requiring indigency clauses in sponsor contracts as not all studies will be qualifying, and not all services within a qualifying study will be billable

This article was co-authored with Cassie Cruz-Montez, MHA, YCCI Research Billing Compliance Analyst, Yale School of Medicine, Yale Center for Clinical Investigation.