Corporate Administrative/Medical Policy Guidelines (Medical Necessity, Investigational/Experimental) - CAM 138

Description:
Corporate Administrative/Medical Guideline consists of medical guidelines and payment guidelines. Benefits and eligibility are determined before medical guidelines and payment guidelines are applied. Medical guideline is not an authorization, certification, explanation of benefits or a contract. Benefits are determined by the contract of benefits that is in effect at the time the services are rendered.

Guideline Statement
Medical Guidelines describe situations in which medical services are medically necessary and whether they are investigational/experimental. Medical guidelines are written to address the most frequently occurring clinical situations for the majority of people. Because of the infinite variety of clinical circumstances, some cases may be appropriate for additional review with individual consideration. Medical guidelines are based on the most appropriate medical information available at the time they are written. Because of the changing nature of medical science, this health plan reserves the right to review and update these policies periodically. 

Payment Guidelines provide (claims payment) editing logic for CPT, HCPCS and ICD-CM coding. Payment guidelines are developed by the clinical staff, and include yearly coding updates; periodic reviews of specialty areas based on input from specialty societies and physician committees; and updated logic on current coding conventions. Listed below are such services and definitions:

Medical Necessity: This health plan will provide coverage for medically necessary services when it is determined that the medical criteria and guidelines below are met:


General:

  • Service is medically appropriate for the symptoms and diagnosis, treatment of the condition, illness, disease or injury.
  • Service is provided for the diagnosis or the direct care and treatment of the member’s condition, illness, disease or injury.
  • Service is in accordance with generally accepted practice standards of good medical practice in the community. 
  • Service is not primarily for the convenience of the patient, the patient’s family or the patient’s provider.
  • Service or supply must not be experimental, investigational or cosmetic in purpose.

**Only the member’s medical condition is considered when deciding medical necessity. The fact that a physician ordered, prescribed, recommended or approved a service or supply does not, in itself, make the services medically necessary.

***For Federal Employee Program (FEP) members, please refer to the FEP Service Benefit Plan at www.fepblue.org for the plan-specific definitions for medical necessity and experimental/investigational for this contract.

Least Costly Setting
If there is precertification on file with documentation supportive of the medical necessity for the setting being requested, reimbursement will be allowed.

If there is precertification on file for a service that is medically necessary, however, does not have the appropriate documentation to support the least costly setting (ASC), the professional fee will be reimbursed and the facility charge will be denied.

**Only the member’s medical condition is considered when deciding least costly setting. The fact that a physician ordered, prescribed, recommended or approved a specific place of service or supply does not, in itself, make the place of service medically necessary.

Investigational/Experimental: These are terms used to define the use of a service or supply that is not recognized by the Plan as standard medical care for the condition, disease, illness or injury being treated. This means that the procedure, treatment, supply, device, equipment, facility or drug (all services) falls into one of these categories:

  • It does not have final unrestricted market approval from the Food and Drug Administration (FDA) or final approval from any other governmental regulatory body for the use in treatment of a specified condition.
  • It does not have scientific evidence that permits conclusions concerning the effect of the technology on health outcomes.
  • It does not improve the net health outcome.
  • It has not been found to be as beneficial as any established alternatives.
  • It does not show improvement outside the investigational settings.

Over the Counter: Services that are available over the counter, that are available direct to the consumer, that do not require physician prescription and/or that do not require continuous ongoing physician oversight and management in order to be safely and effectively administered are not eligible for benefit coverage.

Bundling Guidelines: Applies to claims reviewed for determination of whether services are considered to be mutually exclusive, incidental or integral to the primary services rendered. Services considered to be one of the above are not typically allowed additional reimbursement. Participating providers are contracted not to balance bill members when these instances occur. There are instances, however, when an edit is reviewed for appropriateness or change in status. If the edit is opened to allow separate reimbursement, payment will be allowed from the date of change. There will be NO retroactive claims adjudication for services rendered prior to date of change. Only those claims that have a specific request from the provider/subscriber will be re-evaluated for payment of the opened edit. **Please see CAM 564 for Surgical Guidelines.**

Mutually Exclusive: Two or more procedures that are not typically performed during the same patient encounter on the same date of service. Mutually exclusive rules may also include different procedure code descriptions for the same type of procedures in which the physician should be submitting only one of the procedure codes.

Incidental Procedure:  A procedure that is carried out at the same time as a more complex primary procedure, with the incidental procedures requiring little additional physician resource and/or clinically integral to the performance of the primary procedure. An incidental procedure should not be reimbursed separately on a claim.

**Integral procedures are those that occur in multiple surgery situations when one or more of the procedures are considered to be an integral part of the major or principle procedures. These are procedures that are commonly carried out as part of a total service, which do not meet all the criteria under the Surgery Guidelines and according to the CPT manual need not be listed separately.**

**Claims for services considered to be directly related to a procedure’s global allowance will be considered integral to that service and will not be reimbursed separately.**

**This guideline does not reflect the sole opinion of the Plan or Plan medical director. Although the final decision rests with the carrier, this guideline was developed in cooperation with the Quality Medical Advisory Panel.**

This medical guideline was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

History From 2014 Forward     

07/20/2022

Annual review, no change to policy intent. 

07/01/2021 

Annual review, no change to policy intent. 

07/01/2020 

Annual review, no change to policy intent. 

07/01/2019 

Annual review, no change to policy intent. 

07/09/2018 

Annual review, no change to policy intent. 

07/03/2017 

Annual review, no change to policy intent. 

03/20/2017 

Corrected a typo. 

07/01/2016 

Annual review, no change to guideline intent. 

07/06/2015 

Annual review, no change to policy. 

07/15/2014

Added the following policy verbiage: Services that are available over the counter, that are available direct.

 

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