Purpose of the Manual

The purpose of Regence medical policy is to provide guidelines for determining coverage criteria for specific medical 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 Regence medical policy guidelines and applicable contract language, the contract language prevails.  Regence 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.

Policy Development

Selection of Technologies for Policy Development

Issues are selected for medical policy development through referrals from Regence staff, the physician and provider community, and members.  Priority may be given to the following:

• New diagnostic tests, therapeutic procedures or medical devices for which other good alternatives do not exist
• 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 for members and/or providers
• New information is available in the peer-reviewed scientific literature that may change the status of a technology from investigational to medically necessary

Research Sources

The following sources are considered in the development and revision of Regence medical policy:

1. Policies and technology assessments published by the BlueCross BlueShield Association and the BlueCross BlueShield Association Technology Evaluation Center (TEC)
2. Current published medical literature from peer-reviewed publications
3. Evidence-based guidelines developed by national organizations and recognized authorities
4. Generally accepted standards of medical practice
5. External practicing physician review
6. 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 are:

1. In accordance with generally accepted standards of medical practice;
2. Clinically appropriate, in terms of type, frequency, extent, site and duration, and considered effective for the patient’s illness, injury or disease; and
3. 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

In this manual, the term "investigational" means that the medical technology does not meet Regence's technology assessment criteria, as defined below. If any one or more of the criteria are not met, the technology will be 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 the updating of 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.  In order for a technology to be considered medically necessary, all five criteria must be met.  As noted above, if any one or more of the following criteria are not met, then the technology is considered investigational:

1. The technology must have final approval from the appropriate government regulatory bodies.
• A device must have final approval from the Food and Drug Administration (FDA) for those specific indications and methods of use that The Regence Group is evaluating.
• Any approval that is granted as an interim step (i.e., Treatment IND) in the FDA 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. Scientific evidence and expert opinion provide the basis for summarizing the potential net health outcome.
   • 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.

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.

External Physician Review

All new and revised TRG medical policies are sent for review in draft form to external practicing physicians.  Physicians who wish to participate in this process may contact Regence Medical Policy at: www.regence.com/trg/contact/

Approval Process

All policy drafts, including analyses of the scientific evidence and summaries of the external expert opinion, are presented to Regence 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 regularly.  Policies may be reviewed prior to their scheduled review date if new scientific evidence that would alter the policy criteria becomes available sooner.

Medical Policy Dissemination

Medical policies are published on-line and available to members, providers and the general public at www.regence.com/trgmedpol.  Significant policy changes are communicated through provider newsletters and are noted on-line at:  http://blue.regence.com/trgmedpol/update/