Article | October 16, 2020

Developing A Clinical Trial Budget Following Medicare's Clinical Trial Policy And Device Regulations

Source: Advarra

By Lisa R. Pitler, JD, MS, RN, CHRC, Managing Director, Regulatory Consulting

Healthcare Software For Financials

Medicare and Clinical Trials

There are three regulations addressing Medicare coverage in clinical trials:

  • Medicare Coverage Related to Investigational Device Exemption (IDE) Studies
  • Clinical Trial Policy: National Coverage Determination (NCD) for Routine Costs in Clinical Trials (310.1)
  • Coverage with evidence development (CED): Centers for Medicare & Medicaid Services (CMS), as part of the national coverage determination (NCD), may determine coverage of an item or service only in the context of a clinical study, which typically also involves a registry. The NCDs requiring CED are listed here.

All three of the regulations allow Medicare beneficiaries to participate in clinical trials, as Medicare payment (coverage) is no longer precluded. However, rules must be followed to prevent triggering the False Claims Act and other fraud and abuse laws arising from noncompliance. In this blog, we’ll discuss these challenges, and suggest strategies to assist with this process.

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