|Topic: Medical Policy
Development and Review Process
||Date of Origin: January 1996
|Policy No: 01
||Last Reviewed Date: November 2021
|Next Review Date: September 2022
||Effective Date: December 1, 2021
Purpose of the Manual
The purpose of a medical policy is to provide
guidelines for determining coverage criteria for specific
medical and behavioral health technologies, including
procedures, equipment, and services. In order
to be eligible for coverage, all services must be medically
necessary (unless otherwise provided in the member's
benefits contract). To the extent there are any
conflicts between medical policy guidelines
and applicable contract language, the contract language takes precedence. Medical policy is not intended
to override the health insurance contract that defines
the insured’s benefits, nor is it intended to
dictate to providers how to practice medicine. Physicians
and other health care providers are expected to exercise
their medical judgment in providing the most appropriate
Selection of Technologies for Policy Development
Issues are selected for medical policy development
through referrals from staff, physicians, provider communities, and members. Priority may
be given to the following:
- New diagnostic tests, therapeutic procedures, or medical devices for which no other good alternatives exist;
- Medical technologies that may have a safety concern;
- Medical technologies that are considered life-saving;
- Medical technologies that are controversial with respect to their clinical utility;
- Medical technologies that have generated a high level of interest; and
- New information published in the peer-reviewed scientific literature that may change the status of a technology from investigational to medically necessary.
The following sources are considered in the development
and revision of medical policy:
- Technology assessments publically published and based on a systematic review of the evidence (e.g., BlueCross BlueShield Association, BlueCross BlueShield Center for Clinical Effectiveness, Agency for Healthcare Research and Quality);
- Evidence-based clinical practice guidelines developed by national
organizations and other recognized authorities;
- Generally accepted standards of medical practice;
- External practicing physician review; and
- Government approval status.
Definition of Medical Necessity
Medically necessary or medical necessity means health
care services that a physician, exercising prudent
clinical judgment, would provide to a patient for the
purpose of preventing, evaluating, diagnosing or treating
illness, injury, disease or its symptoms, and that
- In accordance with generally accepted standards
of medical practice;
- Clinically appropriate, in terms of type, frequency,
extent, site and duration, and considered effective
for the patient’s illness, injury or disease;
- Not primarily for the convenience of the
patient, physician, or other health care provider,
and not more costly than an alternative service or
sequence of services at least as likely to produce
equivalent therapeutic or diagnostic results as to
the diagnosis or treatment of that patient’s
illness, injury or disease.
Generally Accepted Standards of Medical Practice
Generally accepted standards of medical practice means
standards that are based on credible scientific evidence
published in peer-reviewed medical literature generally
recognized by the relevant medical community, physician
specialty society recommendations and the views of
physicians practicing in relevant clinical areas and
any other relevant factors.
Definition of Investigational Services
that the medical technology does not meet the
technology assessment criteria outlined
below. If any of the criteria are not met,
the technology is determined to be investigational.
In addition, all services specifically associated with
the investigational technology, including but
not limited to associated procedures, treatments, supplies,
devices, equipment, facilities or drugs, will also
be considered investigational.
Technology Assessment Process
The technology assessment process is applied to both
the development of new medical policies and existing policies. In order to determine whether
a medical technology may be considered medically necessary,
literature searches are conducted and the published
scientific evidence related to each technology is reviewed
against five technology assessment criteria. The technology is considered investigational
if any one or more of the criteria below are not
- The technology must have final approval from the
appropriate government regulatory bodies.
The scientific evidence must permit conclusions
concerning the effect of the technology on health
- This criterion applies to drugs, biological products, devices and any other product or procedure that must have final approval to market from the U.S. Food and Drug Administration or any other federal governmental body with authority to regulate the technology.
- Any approval that is granted as an interim step (i.e., Treatment IND) in the FDA or any other federal governmental body’s regulatory process is not sufficient.
The technology must improve the net health outcome.
- The evidence should consist of well-designed and well-conducted investigations published in peer-reviewed journals. The quality of the body of studies and the consistency of the results are considered in evaluating the evidence.
- The evidence should demonstrate that the technology
can measure or alter the physiological changes
related to a disease, injury, illness or condition.
In addition, there should be evidence or a convincing
argument based on established medical facts that
such measurement or alteration affects the health
- Opinions and evaluations by national medical
associations, consensus panels or other technology
evaluation bodies are evaluated according to
the scientific quality of the supporting evidence
The technology’s beneficial effects on
health outcomes should outweigh any harmful effects
on health outcomes.
The technology must be as beneficial as any established
The technology should improve the net health
outcome as much as or more than established alternatives.
The improvement must be attainable outside the
When used under the usual conditions of medical practice, the technology should be reasonably expected to satisfy technology evaluation criteria #3 and #4.
In addition to the above criteria, the following additional
criteria apply to new diagnostic technologies (e.g.,
imaging studies, laboratory procedures, home monitoring
- Technical feasibility is demonstrated, including
reproducibility and precision. For comparison among
studies, a common standardized protocol for the new
diagnostic technology is established.
- For accurate interpretation of study results, sensitivities,
specificities, and positive and negative predictive
values compared to standards are established.
- The clinical
utility of a diagnostic technique, i.e., how the
results of the study can be used to benefit patient
management, is established. The clinical utility
of both positive and negative tests must be established.
External Physician Review
Regence medical policies are submitted for review to external practicing physicians. Physicians who wish to participate in this process may contact Medical Policy at: https://www.assets.regence.com/trg/contact/index.html. Policies scheduled for upcoming review may be found at: http://blue.regence.com/trgmedpol/uprev/index.html.
All policy drafts, including analyses of the
scientific evidence and summaries of the external expert
opinion are presented to the Medical
Policy Workgroup for final approval. The Workgroup
consists of professional medical policy staff and physician
medical directors from Idaho, Oregon, Utah and Washington.
Medical Policy Updates
Medical policies are re-evaluated and updated annually. Policies
may be reviewed prior to their scheduled annual review date
if new scientific evidence becomes available that would change the policy
Medical Policy Dissemination
Medical policies are published on-line and available
to members, providers and the general public at http://blue.regence.com/trgmedpol/.
Significant policy changes are communicated through
provider newsletters and are noted on-line at http://blue.regence.com/trgmedpol/update/