2014

AAHC Praises Move to Clarify Medicare Payment Guidelines for Clinical Trials

Action Needed to Resolve Compliance Risks and Improve Research Participation

WASHINGTON, Aug. 10, 2011 /PRNewswire-USNewswire/ -- The Association of Academic Health Centers (AAHC) is pleased to learn that the Department of Health and Human Services (HHS), in a coordinated effort that includes the Centers for Medicare & Medicaid Services (CMS), the National Institutes of Health (NIH), and the Food and Drug Administration (FDA), is taking steps towards resolving inconsistent, and often conflicting, guidance and payment policies for routine clinical services performed in the course of clinical trials.

In response to the AAHC's continued efforts to underscore the risks and consequences of conflicting government payment policies and guidelines, HHS Secretary Kathleen Sebelius notified the AAHC in a July 2011 letter that HHS has "begun several initiatives to address these inconsistencies."

Academic health centers and their researchers conduct clinical trials in order to find cures and treatments for diseases and conditions that afflict populations worldwide. "In this vital pursuit they have been in a precarious position of determining which policy or guideline takes precedence and facing the risk of federal enforcement action for following the 'wrong' guidance," said Dr. Steven A. Wartman, AAHC President and CEO. "The AAHC and the academic health center community are encouraged that HHS has acknowledged the importance of addressing, coordinating, and harmonizing the existing payment policies and guidelines."

In 2000 a National Coverage Decision (NCD) was issued, guaranteeing coverage for routine care when beneficiaries participated in a clinical trial.  The intent of the NCD was to significantly improve research outcomes by increasing participation in clinical trials.  Inconsistent application of payment policies by various government agencies and Medicare contractors, and the resulting confusion, diminished the potentially positive impact of the NCD.

"The AAHC supports and looks forward to working with HHS and the CMS towards the mutual goal of resolving this important issue and improving the nation's health and well-being," said Dr. Wartman.  

The AAHC is a national non-profit association representing more than 100 academic health centers, with a mission to improve the nation's health care system by mobilizing and enhancing the strengths and resources of the academic health center enterprise in health professions education, patient care, and research.

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SOURCE Association of Academic Health Centers



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