This Policy version was replaced on March 31, 2025. To find the newest version, go to https://www.bluecrossmn.com/providers/medical-management, select 'See Medical and Behavioral Health Policies', then 'Blue Cross and Blue Shield of Minnesota Medical and Behavioral Health Policies'. This will bring up the Medical Policy search screen. Enter the policy number without the version number (last three digits).
NOTE: This policy does not apply to the following:
This policy addresses Blue Cross’ process for evaluating medical drugs or medical drug indications that are newly approved by the U.S. Food and Drug Administration (FDA). Based upon preliminary assessment, Blue Cross may determine the drug or indication to be investigative until further evaluation is performed.
Definitions:
Medical drugs: Drugs and biologics, including biosimilars, administered by a healthcare professional that process under the medical benefit. These drugs are generally delivered by infusion or injection through intravenous, intramuscular, or other less common routes of administration (e.g., intrathecal; intraocular). Medical drugs do not include drugs that process under the pharmacy benefit, such as self-administered drugs and oral agents.
FDA-approved indication: The specific use for which a drug has been approved by the FDA.
Evaluation period: Up to 6 months from the date a drug is approved by the FDA.
Medical Drug Evaluation Process
Blue Cross’ Medical Drug Evaluation Process involves clinical review of new FDA-approved medical drugs or medical drug indications within 6 months of FDA approval. The clinical review includes evaluation of published data to determine whether the drug or indication is medically necessary or investigative based on evidence of safety, effectiveness, and effect on health outcomes. During the Blue Cross Medical Drug Evaluation Process, new FDA-approved medical drugs or medical drug indications are considered EXPERIMENTAL/INVESTIGATIVE until the evaluation process is completed.
Drugs and Indications Impacted by Blue Cross’ Medical Drug Evaluation Process: New FDA-approved medical drugs or medical drug indications under evaluation by Blue Cross are found on the Medical Drug Evaluation Process List, which can be accessed via the following steps: (1) Go to providers.bluecrossmn.com; (2) Under ‘Tools & Resources’ select ‘See medical policy and prior authorization info’ (3) ‘See Medical and Behavioral Health Policies’ and select ‘Medical drug evaluation list - new FDA-approved drugs under clinical review (PDF).’ This list will be updated, and providers will be notified via a Provider Quick Point as new FDA-approved drugs and indications are added or removed from the list.
NOTE: Blue Cross may determine not to impose a Medical Drug Evaluation Process for certain new FDA-approved medical drugs or medical drug indications. In the absence of a specific medical policy, these drugs and indications may be reviewed according to Medical Policy II-173, Accepted Indications for Medical Drugs Which are not Addressed by a Specific Medical Policy.
No additional statements.
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® 2023. All rights reserved.
CDT codes copyright American Dental Association® 2023. All rights reserved.
