Study identifies potentially influential financial interests among many commenters.


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In determining what drugs, products, or procedures are eligible for Medicaid coverage, many state agencies seek public comments on proposed guidelines. But how useful are these comments? A recent study in JAMA Internal Medicine sought to answer this question by examining comments submitted over a two-year period to the health technology assessment programs in Oregon and Washington.


The study focused on the commenters themselves: who were they, and what, if any, ties did they have to the products or companies on which they were commenting? The researchers examined 25 guidance reports from the state agencies that met the criteria for inclusion in the study and a total of 195 public commenters on these reports. They found that of 165 commenters for whom information about financial ties could be ascertained, 77 (46.7%) had financial ties to the manufacturers of products associated with the guidance reports.


Of all 195 commenters, 25 (12.8%) were affiliated with the product industry and 79 (40.5%) were physicians. Some 174 commenters expressed an opinion about the product in question and of these, 98% commented favorably about either the product or the prospect of Medicaid coverage. Forty-one commentators (21%) provided a total of 641 references in support of their positions. Of these references, 8.7% were randomized clinical trials involving more than 200 people; the others were smaller randomized or observational studies.


Ultimately, the comments appear to have had little influence on state officials shaping Medicaid coverage. Most agency coverage guidance was unchanged between the draft proposal and the final report. Of the two reports in which changes were found, the final recommendation was to expand coverage. Though their study was limited to only two states, the researchers concluded that "public comment periods do not appear to enhance evidence-based approaches to state health technology assessment programs."-Frank Brodhead


Ahn R, et al JAMA Intern Med 2019 Nov 11 [Epub ahead of print].