On September 29, 2008, the Centers for Medicare & Medicaid Services ("CMS") issued Medicare Learning Network ("MLN") Matters Article Number SE0822 ("Article"), providing clarification regarding Medicare payment of routine costs associated with clinical trials as set forth in the Clinical Trial Policy ("CTP") and Chapter 16, Section 40 of the Medicare Benefit Policy Manual (CMS Pub. 100-02). The guidance is in the form of FAQs related to when Medicare may be billed for an item or service that is not reimbursed either by non-Medicare payors or the indigent. Specifically, the Article offers the following information:

  • Medicare payments cannot be made, and a Medicare beneficiary cannot be charged for the routine costs of a clinical trial, if (1) the routine costs are furnished gratuitously, or (2) private insurers deny the routine costs and the provider does not pursue the non-Medicare patients for payment after the denials. (Note: We are considering the impact of this last statement given that CMS is articulating coverage based on claim denials of other payors, which, in fact, may vary by payor. Please look for additional analysis of the issue in a forthcoming Sonnenschein e-Alert.)
  • Medicare payment may be made for Medicare beneficiaries even if the routine costs of a clinical trial are not billed to indigent non-Medicare patients. That is, the provider of routine clinical trial services may waive payment for an indigent patient (if the provider has determined that the patient is indigent due to a valid financial hardship), but bill Medicare for a beneficiary (who is not indigent) and bill the relevant beneficiary for co-payments and his/her deductible.

CMS also responded to a question about the permissibility of waivers of co-payment amounts for clinical trial enrollees. The Article provides:

  • A fraud and abuse problem may arise if a research sponsor offers to pay cost-sharing amounts owed by a Medicare beneficiary in a clinical trial. However, consistent with existing Medicare policy and Office of Inspector General guidance, waiving the collection of charges to uninsured patients of limited means may be permissible, so long as the waiver is not linked in any manner to the generation of business payable by a Federal health care program.

You may view a copy of MLN Matters Number SE0822 on our web site at http://www.sonnenschein.com/practice_areas/healthcare2/ofInterest_detail.aspx?id=47728.