Coverage Guidelines and Definitions

Number 10.01.511

Effective Date December 22 2014

Revision Date(s) 12/22/14; 04/14/14; 07/08/13; 08/14/12; 08/05/11; 06/08/10; 06/09/09; 01/08/08; 07/10/07; 07/11/2006;07/12/05; 02/08/05; 02/10/04; 08/12/03; 01/01/03

Replaces N/A



The purpose of this document is to provide guidelines and definitions to which Company associates and affiliates may refer when utilizing Medical Policies to make a medical decision related to services proposed for, or provided to, members.

The majority of Company Medical Policies are adopted directly from the Blue Cross Blue Shield Association (BCBSA) Medical Policy Reference Manual. When the Company chooses to amend BCBSA policy because of evidence based medical outcomes, new peer-reviewed medical literature, local medical standards, state/federal mandates or when BCBSA does not address a medical issue, a new or revised policy is developed by the Company.

Note: When using Medical Policies, member contract provisions, restrictions, and exclusions supersede Company Medical Policies.

Related Policies


Technology Review


Noncovered Services and Procedures

Policy Guidelines



Company Medical Policy Development and Approval Process

Medical Policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs, or devices. Sources used in creating and adopting Medical Policies may include the BlueCross BlueShield Association (BCBSA) Medical Policy Reference Manual, Technology Evaluation Center (TEC) Assessments, National Comprehensive Cancer Network (NCCN), UpToDate®, Hayes Inc. Knowledge Center and national recommendations developed by Physician Specialty Organizations. Additional sources of information shall include credible scientific evidence published in peer-reviewed scientific literature generally recognized by the relevant medical community, practicing physician input, Independent Review Organization materials, vendor-supplied information and any other clinically relevant factors.

On occasion, Medical Policies may be developed and revised based solely on legal statute, state or federal mandates in lieu of the resources described above.

Company Medical Policies are developed or reviewed and revised by - Medical Services Administrators (licensed registered nurses or PHD trained scientists) and Pharmacists with the support of Company Medical Directors, who are licensed physicians. Final adoption of Medical Policies is by the Premera Medical Policy Committee, which is composed of licensed health care professionals.

Company Medical Policies are reviewed, updated as necessary and approved at least annually. Any policy may be reviewed more frequently based on significant changes in the scientific literature or clinical practice standards.

The Company Medical Policy Committee meets 9-12 times a year and reports within the Company to the Quality Management Program at least twice per year.

The Medical Services Administrators, Pharmacists and Medical Directors:

  • Review and revise existing Company Medical Policies.
  • Develop Company Medical Policies as needed.
  • Prioritize issues identified as potentially needing a Medical Policy to support benefit adjudication.
  • Ensure input from practicing physicians is obtained during the development and review processes for selected Company-developed polices.
  • Document the use of consistent methodology during review or development of Medical Policies.
  • Collaborate with Operations staff in developing implementation plans for Medical Policies.
  • Communicate policy changes to Company staff and Company-contracted providers and practitioners.
  • Ensure that Medical Policies are available on-line to Company associates, providers and members.

The Medical Policy Committee reviews all new and revised Medical Polices during the Medical Policy Committee meeting or by electronic vote and:

  1. Approves as presented.
  2. Approves with minor changes.
  3. Requests further revision/research with policy returning to a future meeting for adoption by the Committee.
  4. Recommends that a policy is reviewed by an Advisory Panel or individual matched specialty physician and presented again at a future meeting of the Committee.
  5. Approves deletion/archiving of Medical Policies.

Exceptions to the Usual Policy Approval Process

On rare occasions, an issue is identified that may have a significant impact on members, practitioners, providers, and the Company. Development of a new policy or revision of an existing policy in a short-time period may be critical and fall outside of the usual developmental timelines. In this instance, a Medical Policy may be adopted or revised by an alternate process.

The Chair of the Medical Policy Committee may call a special meeting to discuss a specific policy or, may send a written communication to all Medical Policy Committee members, describing the issue and presenting a proposed policy in draft form. The communication will also request a written response to the proposed policy by a specific date. If the members of the Medical Policy Committee agree on the draft policy, the Chair of the Committee will set the effective date of the policy.

In the case of medical policies with updates related to formulary changes, and not on the basis of evidence of new literature, MPC approval is not required.

Policy Publication Process

After adoption of a new or revised Medical Policy, policies will be available in the electronic policy format within 10 working days of the effective date of the policy. Providers and practitioners are notified at least 90 days prior to the effective date of a policy with any changes that may have a significant impact on provider reimbursement.


Experimental or Investigative Definition

Experimental or Investigational services include a treatment, procedure, equipment, drug, drug usage, medical device, or supply that meets one or more of the following criteria as determined by the Company:

  • A drug or device, which cannot be lawfully marketed without the approval of the U. S. Food and Drug
  • Administration (FDA), and has not been granted such approval on the date the service is provided.
  • The service is subject to oversight by an Institutional Review Board.
  • No credible scientific evidence demonstrates that the service is effective in clinical diagnosis, evaluation, management, or treatment of identified condition.
  • The service is the subject of ongoing clinical trials to determine its maximum tolerated dose, toxicity, safety, or efficacy.
  • Evaluation of credible scientific evidence indicates that additional research is necessary before the service can be classified as equally or more effective than conventional therapies.

Credible scientific evidence includes, but is not limited to, reports and articles published in authoritative peer- reviewed medical and scientific literature generally recognized by the relevant medical community, and assessments and coverage recommendations published by the Technology Evaluation Center (TEC).

Medical Necessity/Medically Necessary Definition

Those covered services and supplies that a Physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an 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.

For these purposes, “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.

The fact that services were furnished, prescribed, or approved by a physician or other qualified provider does not in itself mean that services were medically necessary.

NOTE: A small number of member contracts may contain differing definitions of investigational or medically necessary services. The member booklet should be consulted for the definitions of investigational and/or medically necessary for that group.


Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply. This medical policy does not apply to Medicare Advantage.







Policy numbered to allow listing as an Administrative Policy.


Added National Comprehensive Cancer Network to development and approval process section.


Replace Policy. Policy converted to new policy format, policy sections rewritten and reordered to support the new format, electronic voting, Pharmacist involvement in policy updates/development, and ICD-10 codes added to coding section.


Replace Policy. Minor edits made for clarity. No change to the intent of the policy.


Update Coding Section – ICD-10 codes are now effective 10/01/2014.


Replace policy. MCG™ and Up-To-Date® added as resources. Clarification added regarding differing member contract definitions of investigational and medically necessary services. Information on medical policy formatting and sample medical policy format deleted. Other minor edits made.


Annual Review. Clarification added on other sources used in revising or creating medical policy. “On occasion, Medical Policies may be developed and revised based solely on legal statute, state or federal mandates in lieu of the resources described above”.


Update Related Policies. Add 10.01.517.


Interim update. Description section updated by removing MCG™ from the list of sources utilized in developing and adopting medical policies; clarifying statement added that medical policies with updates related to formulary changes, and not on the basis of evidence of new literature, do not require MPC approval.

Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
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