Or. Admin. Code § 409-060-0120 - Health Evidence Review Commission Process for Evidence-based Reports

(1) The Commission shall base its reports on scientific evidence, taking into account the strength of the evidence, including an assessment of any biases present. Meetings shall be public and conducted in a manner consistent with the Commission's policies and procedures.

(2) Topics for review shall be publicly identified at least 28 days prior to the initial Subcommittee meeting at which a draft evidence-based report is reviewed. In this notice, the Subcommittee shall make publicly available the primary evidence source documents to be used in creating the initial draft report, except when source documents are proprietary. If additional sources are added to the initial draft report after this notice, the Subcommittee shall publicly identify them no later than 14 days prior to the Subcommittee meeting where they will be discussed. In lieu of proprietary source documents, the Subcommittee shall make publicly available a citation of the evidence source. In the case of a proprietary evidence source, a full listing of citations from the proprietary source shall be made available when allowed by the source. If providing the citations is not allowed or not otherwise feasible, a summary of the evidence findings will be provided at least 14 days in advance of the meeting at which the initial draft report will be discussed.

(3) When developing an evidence-based report other than a coverage guidance, the Commission or its designated Subcommittee shall consult with two or more ad hoc experts on the subject matter of the evidence-based report. Subcommittee shall publicly solicit ad hoc experts at least 28 days prior to the meeting at which it reviews the initial draft evidence-based report. One of the ad hoc experts must be a provider who manages patients who would potentially receive the treatment, service or device in question. Candidates wishing to serve as ad hoc experts shall disclose conflicts of interest according to HERC bylaws. The Authority shall appoint ad hoc experts that best meet the needs of the state, considering any conflicts of interest, and shall not be limited to those who have volunteered to serve.

(4) After the Subcommittee reviews the initial draft report, the subcommittee may revise the initial draft report. The Subcommittee shall then solicit public comment on this version of the draft report over a 30-day period. Draft reports posted for comment shall include citations for all sources used in developing the report and a summary of evidence findings. The Subcommittee shall publicly disclose written comments received during the 30-day period, draft responses and additional revisions (if any) to the draft report at least seven days before the Subcommittee meeting at which the Subcommittee reviews public comments. After discussing the available evidence and considering public comment, including additional verbal testimony, the Subcommittee shall make conclusions as to the overall importance of beneficial effects versus potential harms and approve its final draft evidence-based report reflecting these conclusions.

(5) Before an evidence-based report is reviewed at a Commission meeting, a final draft report approved by the Subcommittee, along with all written public comments received during the public comment period and the Subcommittee's responses to these public comments shall be made publicly available 14 days prior to the meeting. At the meeting, the Commission shall consider the Subcommittee's approved draft report and accept further public comment.

(6) After evaluating the report and public comments the Commission may take one of three actions:

(a) Accept the report as written.

(b) Make edits to the report and accept as modified.

(c) Return the report to the Subcommittee with recommendations for further work.

(7) The Commission or its Subcommittees may revise evidence-based reports when additional information relevant to the report is presented to the Commission or its Subcommittees. The Commission or its Subcommittees may initiate a review of evidence-based reports at the request of interested parties who provide information or interpretations not considered in developing an existing evidence-based report. The Commission may also elect to retire a coverage guidance based on an assessment of the importance of the coverage guidance and the resources that would be required to update it. HERC shall annually solicit requests to revise its coverage guidances and any requests shall be presented to HERC at a regular meeting along with the results of staff research on the topic and any recommendations related to the request.

Notes

Or. Admin. Code § 409-060-0120

OHP 4-2013, f. & cert. ef. 2-1-13; OHP 5-2016, f. & cert. ef. 4/19/2016; OHP 17-2016, f. & cert. ef. 12/22/2016

Stat. Auth.: ORS 414.695 & 413.042

Stats. Implemented: 414.695 & 414.698