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.

Takeaways

  • 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).

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.