Financial Conflicts of Interest in Public Comments on Medicare National Coverage Determinations of Medical Devices

The Centers for Medicare & Medicaid Services (CMS) issues National Coverage Determinations (NCDs) for services or products with questions regarding effectiveness or newly available evidence, among other reasons.¹ NCDs are binding decisions affecting 64 million Medicare beneficiaries and often influence coverage decisions of other payers. The NCD process generally includes a formal evidence review, public comment period, draft CMS coverage proposal, and another public comment period before finalization.¹ CMS encourages public comments during this process and must consider and respond to all those submitted.^1,2 However, the characteristics of public commenters and whether they have financial conflicts of interest (COIs) with industry are unknown.

We conducted a cross-sectional study of all public comments for all therapeutic medical device NCDs finalized between June 2019 and June 2022: pulmonary embolectomy; transcatheter mitral valve repair; artificial hearts and related devices, including ventricular assist devices; and transcatheter aortic valve replacement.

We manually reviewed all comments and classified commenters by affiliation (eMethods in Supplement 1). We determined whether commenters supported or opposed expanding coverage, except for the transcatheter aortic valve replacement NCD, which focused on hospital volume requirements. For physicians, teaching hospitals, and organizations, we determined whether financial COIs, defined as payments from manufacturers potentially affected by the NCD because of their Food and Drug Administration–authorized device(s) or device(s) at a late stage of development during public comment periods, were disclosed within the public comment; disclosure is not required.

For physicians and teaching hospitals, we identified all payments from these manufacturers using the Open Payments database.³ We distinguished general (eg, consultant fees, travel and meal expenses) from research payments, counting those between 2015 and the public comment year.³ For other organizations, excluding device manufacturers and their trade organizations, we determined potential financial COIs by sequentially examining the organization’s website sponsor section, annual disclosures, and an online search. Data were summarized with descriptive statistics using Microsoft Excel and R. In accordance with 45 CFR §46, this study of publicly available information involving no patient records did not require institutional review board approval or informed consent.

Overall, 681 public comments were submitted to the 4 NCDs, including 421 (62%) from individual physicians, 6 (1%) from groups of multiple physicians, 49 (7%) from patients or family members, and 50 (7%) from teaching hospitals or health systems (Table 1). Among the 3 NCDs in which CMS was considering expanding coverage, 424 of 428 comments (99%) supported coverage expansion.

Of the 444 physician commenters (including individual physicians and those from groups of multiple physicians) identified on Open Payments, 338 (76%) had received at least 1 financial payment (337 [76%] general and 138 [31%] research related) from device manufacturer(s) potentially affected by the NCD (Table 2), 1 (0.3%) of whom disclosed the financial COI. Physicians’ median total value of general payments was $5041 (IQR, $1824-$22 743). Of the 53 unique teaching hospitals (including teaching hospitals under health systems), 44 (83%) received at least 1 general payment (median, $28 567; IQR, $5830-$120 717) from device manufacturer(s), but none disclosed the financial COI. Of the 66 organizations (excluding device manufacturers and trade organizations) that submitted public comments, 52 (79%) had financial COIs, 1 (2%) of which disclosed.

For CMS NCDs of medical devices, nearly all physicians, teaching hospitals, and organizations that submitted public comments supported expanding coverage. More than three-quarters of these public commenters had financial COIs with device manufacturer(s) potentially affected by the NCD that would benefit from coverage, and although industry has a legitimate interest in engaging in CMS’ public comment solicitation process, these financial COIs were rarely disclosed.

This study is limited to therapeutic medical devices, which are among the most common NCDs. Ultimately, CMS retains decision-making authority for the final NCD.¹ Given the known association between financial COIs and decisions that favor industry,⁴ policies to promote transparency of public commenters are needed to ensure CMS can consider all viewpoints in an informed manner. These could include requirements for standardized disclosure of financial COIs and linkage to the agency’s Open Payments database. CMS could also encourage participation of commenters without financial COIs.

Accepted for Publication: July 13, 2023.

Published Online: August 17, 2023. doi:10.1001/jama.2023.14414

Corresponding Author: Sanket S. Dhruva, MD, MHS, University of California, San Francisco, 4150 Clement St, Bldg 203, 111C, San Francisco, CA 94121 (sanket.dhruva@ucsf.edu).

Author Contributions: Dr Lu had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Lu, Ross, Redberg, Dhruva.

Acquisition, analysis, or interpretation of data: Lu, Ji, Ge, Ross, Ramachandran, Dhruva.

Drafting of the manuscript: Lu, Ji, Ge, Dhruva.

Critical review of the manuscript for important intellectual content: All authors.

Statistical analysis: Lu.

Obtained funding: Redberg.

Administrative, technical, or material support: Ramachandran, Dhruva.

Supervision: Lu, Dhruva.

Conflict of Interest Disclosures: Ms Ji reported receiving funding from Arnold Ventures during the conduct of the study. Dr Ross reported receiving grants from the Food and Drug Administration, Johnson and Johnson, Medical Devices Innovation Consortium, Agency for Healthcare Research and Quality, National Institutes of Health/National Heart, Lung, and Blood Institute, and Arnold Ventures outside the submitted work; serving as an expert witness at the request of relator's attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc that was settled September 2022; and serving as the current chair (unpaid) of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) for the Centers for Medicare & Medicaid Services. Dr Ramachandran reported receiving grants from Arnold Ventures for a research and policy program titled Yale Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT), the Stavros Niarchos Foundation for a research project on public research and development, and the Food and Drug Administration (FDA) for a research project on clinical trial diversity; receiving consultant fees from the ReAct-Action on Antibiotic Resistance Strategy Policy Program outside the submitted work; serving as chair (unpaid) of the FDA Task Force for Doctors for America; and serving as board president (unpaid) for Universities Allied for Essential Medicines. Dr Redberg reported receiving research support from Arnold Ventures and serving on the Institute for Clinical and Economic Review California Technology Assessment Forum. Dr Dhruva reported receiving research support from Arnold Ventures and the Department of Veterans Affairs and serving on the Medicare Evidence Development and Coverage Advisory Committee and Institute for Clinical and Economic Review California Technology Assessment Forum. No other disclosures were reported.

Funding/Support: This study was supported by Arnold Ventures. Dr Dhruva was supported by the Department of Veterans Affairs Health Services Research and Development (1IK2HX003357).

Role of the Funder/Sponsor: Arnold Ventures and the Department of Veterans Affairs had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Disclaimer: The views expressed in this article are those of the authors and do not reflect those of the US Department of Veterans Affairs or the US government. Dr Ross is a Deputy Editor at JAMA and Dr Redberg was recently the Editor of JAMA Internal Medicine but they were not involved in the review of or any decisions regarding this article.

Data Sharing Statement: See Supplement 2.

Additional Contributions: We thank Audrey D. Zhang, MD (Duke University School of Medicine), for her assistance in manuscript reviews and Marley P.D. Magee (University of California, Los Angeles) and Michelle Gomez (Berkeley High School) for their assistance in data collection. Dr Zhang, Ms Magee, and Ms Gomez were not compensated for their contributions.