Introduction: The Centers of Medicare & Medicaid Services (CMS) relies on public comments
to assist in determining the coverage of services and products for its beneficiaries. The
characteristics of those submitting comments, their possible financial relationships, and the
evidence submitted to support their positions for national coverage determinations (NCDs) is
unknown.
Question: What is the extent of possible financial influences on commenters and the evidence
they submit in public comments about the Centers of Medicare & Medicaid Services’ proposed
national coverage determinations (NCDs)?
Aims: To describe characteristics of public commenters and possible financial ties as well as the
submitted supporting evidence and its financial support.
Methods: This was a cross-sectional study of all public comments for all NCDs about
therapeutic medical devices from June 2019 through August 2022. We assessed the proportion of
comments from physicians and teaching hospitals with financial ties to device manufacturer(s)
that would benefit from expanded coverage, measured by total payment amounts on Open
Payments, and their rates of disclosures. We also measured the proportion of comments from
non-hospital and non-device manufacturer organizations with financial ties to the device
manufacturer(s), found through a structured web search, and their rates of disclosure. The
proportion of evidence submitted by commenters that had direct funding from device
manufacturer(s) or authors with financial relationships was also evaluated.
Results: A total of 681 total comments were manually reviewed. Of the 444 identifiable
physicians contributing comments , 338 (76%) had financial conflicts; only a single physician
disclosed the conflict. Of 45 teaching hospitals/health systems submitting comments, 39 (87%)
had financial conflicts; none were disclosed. The median payment to physicians and teaching
hospitals from relevant device manufacturer(s) was $2,624 (interquartile range [IQR]: $51 - $
51,226) and $49,262 (IQR: $5,211- $339,330), respectively. Of the 66 organizations that
submitted comments, 52 (79%) had financial conflicts; a single organization disclosed. Of the
170 research publications cited that had funding and/or author disclosure sections, 96 (56%)
either had funding and/or an author with financial ties from manufacturers benefiting from
expanded device coverage.
Discussion: Most physicians and organizations submitting comments about CMS NCDs had
financial relationships with manufacturer(s) that would benefit from expanded CMS coverage,
and most of their submitted evidence had direct funding or author(s) with financial relationships
to the relevant manufacturer(s). CMS could minimize potential bias influencing CMS NCDs by
requiring financial disclosures and supporting participation of those without financial conflicts.