This browser is not actively supported anymore. For the best passle experience, we strongly recommend you upgrade your browser.

Social Media Links

| 3 minutes read

Understanding the New Medicaid Research Coverage Regulation

On January 1, 2022, the new Medicaid clinical research coverage law became effective requiring states to add clinical research coverage as a mandatory benefit for Medicaid enrollees. In response, research teams, revenue cycle and compliance professionals alike have been tasked with meeting the requirements under the 2021 amended Consolidated Appropriations Act to provide this new mandatory benefit. To prepare, research sites should proactively take steps to address coverage issues, understand the regulation, and anticipate state coverage decisions. 

In a recently published article in the March 2023 edition of the Health Care Compliance Association's (HCCA) monthly periodical Compliance Today, compliance experts Sarah M. Couture, Catherine Cruz-Montes, and David A. Mata contrast Medicare coverage policies with those found in the new Medicaid research rule to inform how Medicaid coverage will impact research sites and what study sites should be doing in response to this legislation.


  • H.R. 133—The Consolidated Appropriations Act, which housed the new Medicaid research coverage rule—was effective January 1, 2022, but is not yet implemented in many states.

  • According to the new regulation, each state will determine what will be covered in their state plans. Depending on coverage decisions, Medicaid coverage could be more restrictive than Medicare coverage.

  • Research sites should continue to require indigency clauses in sponsor contracts. This may help cover costs that result from potential Medicaid coverage issues.

  • Research sites should continue following Medicare rules for coverage analysis and other clinical research billing processes. As you get information on what your state will cover, you can amend your coverage analysis process to include what will be covered under Medicaid.

  • Creation and dissemination of internal education to study teams and revenue cycle of the new Centers for Medicare & Medicaid Services regulation and attestation form should begin if not already in action.

  • Map out a workflow for the complicated operationalization of completing the attestation form, as there are often several teams involved in authorization processes.

  • As there has been little to no communication from state Medicaid plans on how to submit the attestation form, including receipt and response times, we recommend seeking clarification from your state plan(s).


Share Your Valuable Input in the Ankura Medicaid Clinical Research Coverage Survey

Ankura is launching a study designed to uncover best practices and insights surrounding the 2021 amended Consolidated Appropriations Act. 

We are seeking your valuable input by participating in our short survey designed to help research teams, revenue cycle, and compliance professionals like you navigate the new regulation and implement solutions to ensure compliant billing.  

  • Take our brief survey by March 31, 2023, to receive a complimentary report prepared by Ankura compliance experts with best practices and insights derived from the survey results.

  • Your opinion is important to us. All responses will be kept confidential. 

Please find the link to the survey here to get started. Complete the survey any time before March 31.


Know someone in your organization, peer network, or institution who would benefit from this survey? Please contact Sarah Couture to share with them directly or share the survey link.

This article was originally published in Compliance Cosmos. Copyright [March 2023] Compliance Today, a publication of the Health Care Compliance Association (HCCA).

Download a PDF copy of the full article here.

© 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.
To prepare the [new Medicaid research coverage rule], research sites should proactively take steps to address coverage issues, understand the regulation, and anticipate state coverage decisions.


memo, healthcare compliance, healthcare & life sciences, healthcare operations

Let’s Connect

We solve problems by operating as one firm to deliver for our clients. Where others advise, we solve. Where others consult, we partner.

I’m interested in

I need help with