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The Oregon Administrative Rules contain OARs filed through October 15, 2014
 
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OREGON HEALTH AUTHORITY, OFFICE FOR OREGON HEALTH POLICY AND RESEARCH

 

DIVISION 60

HEALTH EVIDENCE REVIEW COMMISSION

Evidence-based Reports

409-060-0100

Scope

(1) These rules (OAR 409-060-0100 to 409-060-0150) define criteria and processes that the Health Evidence Review Commission shall use to develop evidence-based reports, including medical technology assessments, evidence-based guidelines and coverage guidances. These rules apply to evidence-based reports and revisions to approved evidence-based reports whose development commences on or after February 1, 2013.

(2) The Commission may consider evidence relating to prescription drugs that is relevant to an evidence-based report but may not conduct a drug class evidence review or evidence-based report solely of a prescription drug.

Stat. Auth.: ORS 414.695 & 413.042
Stats. Implemented: 414.695 & 414.698
Hist.: OHP 4-2013, f. & cert. ef. 2-1-13

409-060-0110

Definitions

The following definitions apply to OAR 409-060-0100 to 409-060-0150:

(1) “Ad hoc expert” means an individual identified by the Commission as having particular expertise in a technology or its application.

(2) “Commission” means the Health Evidence Review Commission.

(3) “Coverage guidance” means a report approved by the Commission on a health service or technology which makes coverage recommendations for insurers and health care purchasers in furthering the use of evidence-based healthcare.

(4) “Evidence-based guideline” means an evidence-based report on a health service or technology, for use by health care providers in encouraging the use of the safest and most effective care possible.

(5) “Evidence-based report” means a medical technology assessment, evidence-based guideline or coverage guidance which includes conclusions and recommendations based on the information in the source documents, and which incorporates the clinical context necessary for the information to be properly interpreted by policymakers.

(6) “EbGS” means the Evidence-based Guidelines Subcommittee.

(7) “HTAS” means the Health Technology Assessment Subcommittee

(8) “Medical technology” or “technology” means medical equipment and devices, medical or surgical procedures and other techniques used or prescribed by health care providers in delivering health care to individuals, and the organizational or supportive systems within which health care is delivered.

(9) “Medical technology assessment” means an evidence-based report on the use, clinical effectiveness and risks, and cost of a technology in comparison with its alternatives.

(10) “OHPR” means the Office for Oregon Health Policy and Research.

(11) “Subcommittee” means a subcommittee established by the Commission.

(12) “Trusted source” means a source designated by the Commission for use in developing an evidence-based report.

Stat. Auth.: ORS 414.695 & 413.042
Stats. Implemented: 414.695 & 414.698
Hist.: OHP 4-2013, f. & cert. ef. 2-1-13

409-060-0120

Health Evidence Review Commission Process for Evidence-based Reports

(1) The Commission shall develop evidence-based reports or may direct a Subcommittee to prepare these reports. The Commission shall identify reports from trusted sources to serve as the basis for these reports. 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 30 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, 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 30 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 OHPR Administrator 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 for a period of at least 14 days. 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 becomes available or if the findings of one or more of the source reports change. The Commission or its Subcommittees may initiate a review at the request of interested parties who provide information or interpretations not considered in developing an existing evidence-based report. At a minimum, the HERC or one of its Subcommittees shall review the need to update each report within two years after its adoption or most recent revision.

Stat. Auth.: ORS 414.695 & 413.042
Stats. Implemented: 414.695 & 414.698
Hist.: OHP 4-2013, f. & cert. ef. 2-1-13

409-060-0130

Medical Technology Assessments

Medical technology assessments undertaken by the Commission shall be developed by HTAS and may include any technologies listed in the definition in ORS 414.695 and 414.698(1). Medical technology assessments shall be performed in cases where technology assessments from trusted sources do not exist or require the consideration of additional evidence. Medical Technology Assessments shall include a new search of the current peer-reviewed research on the topic. Assessments shall be developed according to the process described in OAR 409-060-0120 except as described in this section.

Stat. Auth.: ORS 414.695 & 413.042
Stats. Implemented: 414.695 & 414.698
Hist.: OHP 4-2013, f. & cert. ef. 2-1-13

409-060-0140

Evidence-based Guidelines

The EbGS shall develop evidence based guidelines based on one or more existing guideline from trusted sources, which may involve the consideration of additional research. Evidence-based guidelines shall be developed according to the process described in OAR 409-060-0120 except as described in this section.

Stat. Auth.: ORS 414.695 & 413.042
Stats. Implemented: 414.695 & 414.698
Hist.: OHP 4-2013, f. & cert. ef. 2-1-13

409-060-0150

Coverage Guidances

(1) A Subcommittee shall develop coverage guidances which shall be based on reports developed by trusted sources, and may cite supplemental evidence which is more recent or beyond the scope of the report. Coverage Guidances shall be developed according to the process described in OAR 409-060-0120 except as described in this section.

(2) OAR 409-060-0120(3) does not apply to this section. Instead, if the Subcommittee responsible for development of the report determines that it lacks sufficient expertise in the relevant field, or a request is received from an interested outside party, the Subcommittee shall solicit an ad hoc expert to provide additional information. Requests from interested parties to appoint ad hoc experts must be submitted within fourteen days after the public notice announcing the subcommittee’s first review of the initial draft coverage guidance. The subcommittee may solicit ad hoc experts at any time thereafter if the committee determines such expertise is necessary. Candidates wishing to serve as ad hoc experts shall disclose conflicts of interest according to HERC bylaws. Ad hoc experts, if needed, shall be appointed by the OHPR Administrator. The OHPR administrator shall select 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. Ad hoc experts shall answer technical questions and provide clinical context during the review of the evidence.

Stat. Auth.: ORS 414.695 & 413.042
Stats. Implemented: 414.695 & 414.698
Hist.: OHP 4-2013, f. & cert. ef. 2-1-13

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