Tag Archives: advisory opinion

New OIG Advisory Opinion Allows Waiver of Cost Sharing in Research Studies

The Office of Inspector General (OIG) recently issued Advisory Opinion 17-02, allowing waivers or reductions of cost-sharing amounts owed by financially needy Medicare beneficiaries in connection with certain clinical research studies conducted at a non-profit medical center.  In the advisory opinion, the OIG reiterated its longstanding concern about routine waivers of Medicare beneficiary cost-sharing amounts in the absence of financial hardship, and noted this can lead to liability under the anti-kickback statute (AKS).  The research studies were conducted utilizing protocols under the Medicare Coverage with Evidence Development (CED) framework …

OIG Issues Favorable Advisory Opinion for Cost-sharing Waivers and Stipends in a Clinical Research Study

On December 13, 2016, the Office of Inspector General (OIG) issued a favorable Advisory Opinion to a university health system (the Requestor) for two arrangements relating to a federally-funded clinical research study designed by a physician-employee (the Study):

  1. a proposal to waive the cost-sharing obligations of Study participants (Participants) for medically necessary health care services received under the Study protocol (the Proposed Arrangement), and
  2. payment of a stipend to Participants for the time and effort required to participate (the Current Arrangement).
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