Blue Cross Blue Shield of Minnesota Medical Policy

 
 
Medical Policy:
XI-01-004
Topic:
Investigative Indications for Medical Technologies Which Are Not Addressed by a Specific Medical Policy
Section:
Miscellaneous
Effective Date:
September 30, 2019
Issued Date:
August 30, 2021
Last Revision Date:
September 2019
Annual Review:
August 2021
 
 

This policy version was replaced August 29, 2022. To find the newest version, go to https://www.bluecrossmn.com/providers/medical-policy-and-utilization-management, read and accept the Blue Cross Medical Policy Statement, then select “Blue Cross and Blue Shield of Minnesota Medical Policies.” This will bring up the Medical Policy search screen. Enter the policy number without the version number (last 3 digits).

NOTE: This policy does not apply to the following:

  • Medical technologies addressed by a specific medical policy utilized by Blue Cross and Blue Shield of Minnesota (Blue Cross).
  • Medical drugs that are not addressed in a specific policy (see Medical Policy II-173, Accepted Indications for Medical Drugs Which are not Addressed by a Specific Medical Policy).
  • New FDA-approved medical drugs or medical drug indications on Blue Cross’ Medical Drug Evaluation Process List (see Medical Policy II-174, Evaluation Process for New FDA-Approved Medical Drugs or Medical Drug Indications).

This policy describes criteria by which Blue Cross determines whether a medical technology being used is investigative in the absence of a specific medical policy. These criteria are also used in the development and updating of medical policies.

The following is generally considered in evaluating the quality and strength of the scientific evidence:

  • Published in peer reviewed publications that are recognized as reputable by clinicians in the practice specialty;
  • Clinical trials or studies that are controlled and randomized, when possible; Inclusion of an adequate number of subjects to achieve a statistically significant and clinically meaningful outcome for the research question under study;
  • Study participants representative of the population for which the technology is intended;
  • Duration of the study or trial, including follow-up, is sufficient to establish safety and clinical efficacy;
  • Evaluations by nationally recognized technology assessment organizations;
  • Freedom from bias that may affect results because of weakness in study design, analysis or reporting.

Definitions:

FDA-approved indication: The specific use for which a technology has been approved by the FDA.

Medical technology: A device, medical treatment, supplies or procedure provided to a member by a medical provider for the purpose of preventing, evaluating, diagnosing or treating an Illness, injury, disease or its symptoms.

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

A medical technology is considered EXPERIMENTAL/INVESTIGATIVE when ANY of the following criteria are met:

  • No Food and Drug Administration (FDA) approval, if required; OR
  • Available scientific evidence does not permit conclusions concerning the effect of the intervention on health outcomes; OR
  • Not proven to be as safe and as effective in achieving an outcome equal to or exceeding the outcome of alternative therapies; OR
  • Does not improve health outcomes; OR
  • Consensus opinions or recommendations from relevant professional societies or national or local providers in the applicable specialty do not recommend the technology; OR
  • Not proven to be applicable outside the research setting. NOTE:  For more information on research participation see Medical Policy II-19, Coverage of Routine Care Related to Clinical Trials.


Denial Statements

No additional statements.



Links




Blue Cross and Blue Shield of Minnesota medical policies apply generally to all Blue Cross and Blue Plus plans and products. Benefit plans vary in coverage and some plans may not provide coverage for certain services addressed in the medical policies. When determining coverage, reference the member’s specific benefit plan, including exclusions and limitations.

Medicaid products may provide different coverage for certain services, which may be addressed in different policies. For Minnesota Health Care Program (MHCP) policies, please consult the MHCP Provider Manual website.

Medicare products may provide different coverage for certain services, which may be addressed in different policies. For Medicare National Coverage Determinations (NCD), Local Coverage Determinations (LCD), and/or Local Coverage Articles, please consult CMS, National Government Services, or CGS websites. 

Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met.

Blue Cross and Blue Shield of Minnesota reserves the right to revise, update and/or add to its medical policies at any time without notice. Codes listed on this policy are included for informational purposes only and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. 

These guidelines are the proprietary information of Blue Cross and Blue Shield of Minnesota. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Acknowledgements:

CPT® codes copyright American Medical Association® 2022. All rights reserved.

CDT codes copyright American Dental Association® 2022. All rights reserved.