Abstract
This investigation of public reports and websites examines public comments submitted to state health technology assessment programs and evaluates whether they promote expansion of coverage or recommend restriction of coverage.
State Medicaid agencies have various approaches to determine what drugs, devices, procedures, and systems of care are adopted for coverage. Oregon and Washington have created transparent public processes as part of an evidence-based approach. During the development of coverage guidance, public comments are accepted, and every written comment is addressed in a disposition document. Coverage may change in response, but the characteristics of the commenters who engage in this process remain unknown.
We sought to examine the type, source, and tone of public comments submitted to state health technology assessment programs: whether they tend to promote expansion of coverage or recommend restrictive coverage.
Methods
We examined all coverage guidance reports in Oregon and Washington from January 1, 2017, to December 3,1 2018, from the Oregon Health Authority and Washington State Health Care Authority websites.1,2 We included coverage guidance reports in which members of the public provided input on draft reports.
For each final coverage guidance report (after public comment), we reviewed the draft (before public comment), if available, and recorded similarities and differences between final coverage recommendations and draft reports. We collected information on the affiliation of public commenters and the content of their comment. Individuals with multiple affiliations were assigned a single affiliation based on a hierarchy: industry, physician, organization, nonphysician health care professional, government, patient or family member, or other. We rated the enthusiasm for the overall message of each public comment on 4 categories: enthusiasm for health service, neutrality, criticism of health service, and unrelated.
We searched for financial ties among commenters. Financial ties were limited to the company that manufactured the product relevant to the report. We defined a financial tie as compensation of a public commenter in the form of employee relationships, honoraria, speaker’s fees, and/or travel or meals. We searched the Centers for Medicare & Medicaid Services Open Payments3 website for physician public commenters. Financial ties were imputed for individuals who spoke on behalf of an organization; we searched the corporate sponsor section in organizations’ websites to identify financial ties. We did not search for financial ties among nonphysician health professionals, government workers, and patients or family members. We limited the search for financial ties to the 2 years before the publication of the final guidance report.
This study was an investigation of published reports and public websites and therefore was not subject to institutional review board approval according to federal regulations. Descriptive statistics were provided and tabulated with spreadsheet software (Microsoft Excel).
Results
A total of 25 guidance reports (13 from Oregon and 12 from Washington) met our inclusion criteria. Table 1 shows the affiliation and recommendations of 195 public commenters for these reports with a mean 10.3 (range, 0-92) commenters per report. Among the 165 public commenters for whom we could search financial ties, 77 (46.7%) had financial ties with the manufacturers of products associated with coverage guidance reports.
Table 1. Characteristics of 195 Public Commenters on 25 Medicaid Coverage Guidance Reports.
| Public Commenter Status | No. (%) (Total No. = 195) | No. (%) With Financial Ties |
|---|---|---|
| Affiliation | ||
| Industry | 25 (12.8) | 24 (96.0) |
| Physician | 79 (40.5) | 32 (40.5) |
| Organizations | 61 (31.2) | 21 (34.4) |
| Nonphysician health care professional | 19 (9.7) | NA |
| Government | 3 (1.5) | NA |
| Patient or family member | 4 (2.0) | NA |
| Other | 4 (2.0) | NA |
| Recommendation | ||
| Enthusiastic for health service | 171 (87.7) | NA |
| Neutral for health service | 1 (0.5) | NA |
| Critical of health service | 2 (1.0) | NA |
| Unrelated or tangentially related to health service | 21 (10.8) | NA |
Abbreviation: NA, not applicable.
Of all public commenters who expressed an opinion (174 of 195 [89.2%]), 171 (98%) were enthusiastic about the health service and 3 (2.0%) were neutral or critical of the health service. Among the 3 people with neutral or critical views, none had financial ties.
A total of 41 (21.0%) public commenters cited 641 references in support of their testimony, of which 193 references (30.1%) were observational studies, 197 (30.7%) were randomized clinical trials, and 56 (8.7%) randomized trials with more than 200 participants (Table 2).
Table 2. Characteristics of References in Support of Commenter Testimony.
| Characteristic | No. (%) |
|---|---|
| Totala | 641 |
| Observational, noninterventional study | 193 (30.1) |
| Randomized clinical trial, No. of participants | |
| <50 | 30 (4.7) |
| 50-99 | 54 (8.4) |
| 100-199 | 57 (8.9) |
| ≥200 | 56 (8.7) |
| Nonrandomized interventional trial, No. of participants | |
| <50 | 2 (0.3) |
| 50-99 | 1 (0.2) |
| 100-200 | 3 (0.5) |
| ≥200 | 2 (0.3) |
| Guideline | 35 (5.4) |
| Cost-effectiveness study | 25 (3.9) |
| Opinion | 8 (1.2) |
| Systematic review or meta-analysis | 58 (9.0) |
| US Food and Drug Administration documents | 6 (0.9) |
| Other | 105 (16.4) |
| Non-English | 4 (0.6) |
| Unknown (article not found) | 2 (0.3) |
A total of 641 references cited by 41 of 195 public commenters (21.0%).
Among 13 reports in which changes could be assessed between draft and final coverage reports, 13 (85%) were unchanged and 4 had changes (15%). In those 2 in which coverage guidance changed between draft and final coverage, the coverage expanded in scope.
Discussion
Most public comments to these state health technology assessments were enthusiastic or favor expanding coverage. Approximately half of the commenters documented financial ties to the manufacturers of products affected by guidelines, and additional conflicts may exist. Neutral and negative comments were rare (<2%), and made by commenters without financial ties. When commenters provided references to support their views, evidence submitted was predominantly from the lower levels of the hierarchy of evidence. Limitations include the analysis of just 2 states and potential underestimation of financial ties. Public comment periods do not appear to enhance evidence-based approaches to state health technology assessment programs.
References
- 1.Oregon Health Authority Coverage Guidances & Reports on Multisector Interventions. https://www.oregon.gov/oha/HPA/DSI-HERC/Pages/Evidence-based-Reports.aspx.
- 2.Washington State Health Care Authority Health Technology Reviews. https://www.hca.wa.gov/about-hca/health-technology-assessment/health-technology-reviews.
- 3.Centers for Medicare & Medicaid Services. Open payments. https://www.cms.gov/openpayments/. Accessed October 7, 2019.