Coverage Guidance Process
To view the steps of each phase of the Coverage Guidance pro cess, click on the tabs below:
Research & Reporting
- Staff Research
Staff conducts research to identify new topics based on reports from trusted sources. Nominations are also accepted from the public through our nomination survey.
- Scope topics
Staff and the EbGS/HTAS subcommittees define the scope of the coverage guidance, and provide a suggested score for the topic to the HERC. As a part of this process, there is a 7-day public comment period limited to the scope definition.
- Prioritize Topics
HERC prioritizes topics and assigns them to the Evidence-based Guidelines Subcommittee (EbGS) or the Health Technology Assessment Subcommittee (HTAS).
You can follow topic prioritization in HERC meeting materials.
Notice is sent to stakeholders at least 30 days prior to initial review by either the EBGS or HTAS. HERC staff will solicit ad hoc experts if required. Subscribe to receive our public notices.
- Prepare Initial Draft
Staff develops draft coverage guidance, with input from appointed ad hoc experts if necessary. Initial draft is posted to the EbGS or HTAS meetings materials page at least 7 days prior to initial review.
- Initial Review
The subcommittee reviews the initial draft at a public meeting and votes to post the guidance for a public comment period. The subcommittee can also opt to revise the draft, request additional information, or table for additional discussion – in which case the initial draft would require another review before moving to public comment.
Oral comment is accepted at public meetings but may be limited to 5 minutes per topic shared among those who comment.
- Public Comment
The draft guidance approved by the subcommittee is posted online for 30 days of public comment. Policy: HERC Policy on Acceptance of Testimony.
*Written comments can be submitted to HERC.firstname.lastname@example.org. Comments are limited to 1000 words not including any citations or articles.
- Staff Research
Based on public comment, staff research, draft responses and propose revisions to the draft guidance.
- Review Public Comment & Refer to Value-based Benefits Subcommittee
At a public meeting, the subcommittee reviews public comments and staff responses. The subcommittee may approve the coverage guidance and refer it to the Value-based Benefits Subcommittee, revise the coverage guidance, or request additional staff research. If changes are made, the subcommittee may repost the draft coverage guidance for an additional 21-day public comment period, in which case the draft guidance would return to step 3 above.
- VbBS Review
At a public meeting (usually conducted on the same day as HERC will review the coverage guidance), the VbBS reviews staff recommendations for changes to the Prioritized List of Health Services based on the recommendations in the draft guidance. These recommendations usually (but don't always) align with the coverage guidance recommendations. VbBS refers its recommended changes to the Prioritized List to HERC, which will consider them along with the draft coverage guidance.
- HERC Review
At a public meeting, HERC considers the guidance and any associated Prioritized List changes recommended by VbBS for final approval. HERC may approve the recommendations of the subcommittee(s) as submitted, approve an amended version of the coverage guidance and/or Prioritized List changes, or refer the topic back to the subcommittee(s) for further work.
- Staff Monitoring
HERC reviews the need to update each approved guidance once every two years. If a topic is determined to need review, the coverage guidance process begins again, at phase 1, with prioritization. Reviews may be initiated at any time, and may be requested by interested stakeholders. Reviews will be initiated if staff finds new evidence not previously considered, or information indicating misinterpretation of previously available evidence. In order to justify the resources required for an updated review, the evidence in question must be considered likely to alter a recommendation in a way that would significantly impact cost or quality of care for the population in question. Such studies are also typically:
- Randomized controlled trials or systematic reviews of randomized trials demonstrating comparative effectiveness or harm, or large registry or population-based studies demonstrating harm, AND are of
- Moderate or high quality according to HERC criteria
The HERC develops recommendations by using the concepts of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. GRADE is a transparent and structured process for developing and presenting evidence and for carrying out the steps involved in developing recommendations. There are four elements that determine the strength of a recommendation, as listed in the table below. The HERC reviews the evidence and makes an assessment of each element, which in turn is used to develop the recommendations presented in the coverage guidance box. Balance between desirable and undesirable effects, and quality of evidence, are derived from the evidence presented in this document, while estimated relative costs, values and preferences are assessments of the HERC members.
For more about the GRADE methodology, see the GRADE working group web site, and this presentation by HERC member Wiley Chan from the May, 2013 meeting.
Evidence-Based Policy Presentation
This presentation, What Is Evidence-Informed Health Policymaking, by Martha Gerrity from the Center for Evidence-based Policy (CEbP) at Oregon Health and Sciences University (OHSU), discusses the use of evidence for making health policy decisions. Methods of analyzing evidence (e.g., systematic reviews, randomized controlled trials, observational studies) to determine its quality are described. Also discussed are key questions which should be asked when reviewing evidence.
This presentation was made to the Health Technology Assessment Subcommittee of the HERC on March 22, 2012. This video is being posted for use by the HERC and its subcommittees as well others who might benefit from a primer on this topic.