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
To assist with gaining a better understanding of solutions for addressing challenges and aid in development of best practices, Jane Hohn and Sarah Couture at Ankura Consulting, in collaboration with Cassie Cruz-Montes at Yale University, have developed a Medicaid clinical research billing regulation survey. The survey allows participants to share approaches, solutions, and challenges, and also gain access to survey results. The survey can be answered anonymously, but to receive results an email address must be provided. Please feel free to share the link with others that may be interested in this shared information. The survey must be completed by March 31, 2023. We may elect to re-release the survey in the coming months as the implementation evolves, and those who have participated in past surveys will be invited to participate again.
This article was co-authored with Cassie Cruz-Montez, MHA, YCCI Research Billing Compliance Analyst, Yale School of Medicine, Yale Center for Clinical Investigation.
Please send questions to firstname.lastname@example.org.
© Copyright 2023. The views expressed herein are those of the author(s) and not necessarily the views of Ankura Consulting Group, LLC., its management, its subsidiaries, its affiliates, or its other professionals. Ankura is not a law firm and cannot provide legal advice.