Medical policy

Topic: Medical Policy Development and Review Process
Section: Introduction
Policy no: 01
Date of origin: January 1996
Last reviewed date: February 2024
Next review date: September 2024
Effective date: March 1, 2024

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. The same process is used to evaluate medical and behavioral health technologies. 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 care.

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:

1. Technology assessments publicly 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);
2. Peer-reviewed publications;
3. Evidence-based clinical practice guidelines developed by national organizations and other recognized authorities;
4. Generally accepted standards of medical practice;
5. External practicing physician review; and
6. Government approval status.

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 are:

a. In accordance with generally accepted standards of medical practice;
b. Clinically appropriate, in terms of type, frequency, extent, site and duration, and considered effective for the patient’s illness, injury or disease; and
c. 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 are 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.

"Investigational" means 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.

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 met.

1. The technology must have final approval from the appropriate government regulatory bodies.
   • 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.
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes.
   • 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 outcomes.
   • 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 and rationale.
3. The technology must improve the net health outcome.
   The technology’s beneficial effects on health outcomes should outweigh any harmful effects on health outcomes.
4. The technology must be as beneficial as any established alternatives.
   The technology should improve the net health outcome as much as or more than established alternatives.
5. The improvement must be attainable outside the investigational settings.
   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 devices):

1. Technical feasibility is demonstrated, including reproducibility and precision. For comparison among studies, a common standardized protocol for the new diagnostic technology is established.
2. For accurate interpretation of study results, sensitivities, specificities, and positive and negative predictive values compared to standards are established.
3. 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.

Regence medical policies are submitted for review to external practicing physicians. Physicians who wish to participate in this process may contact Medical Policy at: regence.com/provider/library/forms/contact-medical-policy-staff. Policies scheduled for upcoming review may be found at: regence.com/provider/library/policies-guidelines/medical-policy/upcoming-reviews.

All policy drafts, including analyses of the scientific evidence and summaries of the external expert opinion are presented to the Medical and Behavioral Health Policy Governance for final approval. The Governance body consists of professional medical policy staff and a diverse group of physician medical directors from Idaho, Oregon, Utah and Washington, and other key stakeholders from teams involved in the review and application of medical policies.

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 criteria.

Medical policies are published on-line and available to members, providers and the general public at regence.com/provider/library/policy-guidelines/medical-policy/introduction. Significant policy changes are communicated through provider newsletters and are noted on-line at regence.com/provider/library/policies-guidelines/medical-policy/recent-updates.