Health Letter, October 2023
By Robert Steinbrook, M.D.
If you’re not outraged,
you’re not paying attention!
Read what Public Citizen has to say about the biggest blunders and outrageous offenses in the world of public health, published monthly in Health Letter.
Medicare national coverage determinations are made through an evidence-based process that includes public participation. Coverage is limited to items and services that are within the scope of a Medicare benefit category and are “reasonable and necessary for the diagnosis or treatment of an illness or injury.” Typically, the process includes a formal evidence review, a public comment period, a draft coverage proposal and another public comment period before the determination is finalized. Public comments are encouraged; the Centers for Medicare & Medicaid Services (CMS) must consider and respond to the comments that are submitted.
Given the valuable aspects of Medicare’s national coverage determination process, it was very discouraging to learn, from an August 2023 research letter in JAMA, how frequently “public commenters” have financial conflicts of interest with companies potentially affected by the national coverage determination they are commenting on, and that these financial conflicts of interest are “rarely disclosed.” The study examined all public comments for four Medicare national coverage determinations for therapeutic medical devices finalized between June 2019 and June 2022. The medical devices were for pulmonary embolectomy, transcatheter mitral valve repair, artificial hearts and transcatheter aortic valve replacement.
Of the 681 public comments submitted for the four national coverage determinations, 427 (63%) were from individual physicians or groups of multiple physicians and 49 (7%) were from patients or family members. For the three national coverage determinations where coverage expansions were being contemplated, 424 of 428 comments (99%) supported coverage expansion.
Open Payments is a CMS database with information about the financial relationships drug and medical device companies have with doctors and others who provide health care. Using Open Payments data, the researchers found that 338 of 444 physician commenters (76%) that were identified in the database had received at least one financial payment from one or more device manufacturers potentially affected by the national coverage determination. Remarkably, only one of these physicians disclosed their financial conflict of interest. Of 66 organizations (excluding device manufacturers and trade organizations) that submitted public comments, 52 (79%) had financial conflicts of interest, only one of which was disclosed. The findings of this study are consistent with studies of the characteristics and conflicts of public speakers at meetings of the Oncologic Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) and of the FDA’s Anesthetic and Analgesic Drug Product Advisory Committee.
Although CMS, not public commenters, decides the final national coverage determination, the only way for the agency to consider the comments in a knowledgeable manner is with transparency. At a minimum, as the authors of the study state, CMS could require “standardized disclosure of financial [conflicts of interest] and linkage to the agency’s Open Payments database,” as well as proactively seek public comments from more individuals and organizations without financial conflicts of interest.