Comment Letter

COGR's Letter to CMS on COI Procedures

The Council on Governmental Relations (COGR), representing major research institutions, communicated concerns to the Centers for Medicare and Medicaid Services (CMS) regarding the agency's conflict of interest (COI) procedures for research award and contract applications. COGR noted that the current CMS requirements are significantly more burdensome compared to those of other federal funding agencies, both in terms of the volume of information required at the proposal stage and the breadth of individuals and financial relationships subject to disclosure. Among the key concerns highlighted are the need for extensive disclosures for both organizational and personal conflicts at the time of proposal (despite low funding probabilities), unclear regulatory justifications for duplicative financial interest reporting, ambiguous instructions for subcontractors, overly broad definitions of both covered individuals and types of financial interests, and onerous audit and oversight program requirements, particularly for larger contracts.

COGR further observed that many individuals required to disclose information, such as trustees or board members, have no operational role in research activities, rendering much of the disclosure irrelevant. The letter emphasized that existing COI management frameworks under agencies like the Public Health Service (PHS) and the National Science Foundation (NSF) already provide robust protections while focusing disclosure requirements primarily on investigators directly involved in research. The organization advocated for harmonization of CMS policies with those established by other federal agencies, stressing that alignment would reduce unnecessary administrative burden while maintaining appropriate safeguards. COGR expressed willingness to collaborate further with CMS to achieve more practical and clearly defined COI procedures.

This summary was generated with AI. Report Issue
Posted October 6, 2016