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OREGON HEALTH AUTHORITY, HEALTH POLICY AND ANALYTICS




 

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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