Health Care Group Teleconference: Medicare Secondary Payer Rules in the Clinical Trial Context: Update on Current Government Interpretation and Guidance on Addressing Financial Consequences

Practices: Health Care

Mark Barnes, a partner in our New York office and a nationally-recognized research compliance expert, will provide an update on the controversial application of Medicare secondary payor (MSP) rules in the clinical trial context.  The update will:

  • review the 2004 communication issued by the Centers for Medicare & Medicaid Services that created the controversy by applying certain general MSP rules (which render Medicare benefits secondary to benefits payable by a third party payer even if the third party payer states that its benefits are secondary to Medicare benefits or otherwise limits its payments to Medicare beneficiaries) to clinical trials in which a sponsor agrees to pay for services not otherwise covered by a third party payer;
  • summarize recent (and potentially contradictory) statements by CMS officials regarding the communication and the position set forth in the communication;
  • examine the impact of the CMS position on the MSP rules on Medicare payment for clinical trial services as well as negotiations between research sponsors and research institutions; and
  • offer practical guidance to research institutions and research sponsors on how to structure clinical trial agreements to define and control financial liability for clinical trial services under the MSP rules.

The update will provide research sponsors and research institutions with a much-needed overview of the MSP rules as currently applied in the clinical trial context as well as  options for addressing the MSP rules when negotiating clinical trial agreements.


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