Kelly M. Willenberg (kelly@kellywillenberg.com) is President and CEO of Kelly Willenberg LLC in Greenville, SC.
State Medicaid plans have always had varying language on clinical trial coverage since the passing of the National Coverage Determination for Routine Costs in Clinical Trials (310.1) in 2000. Knowing whether an enrollee is able to participate in a clinical trial in the same way a Medicare enrollee or commercially insured patient is able to do is sometimes a guess. With states controlling the process, implementation of the new Consolidated Appropriations Act,[1] which goes into effect in 2022, requiring state Medicaid plans to cover certain costs during some clinical trials, will be challenging for all of the research enterprise.