MA Part B Utilization Management Review with NCD or LCD Policy Number M.17

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Policy Number M.17
MA Part B Utilization Management Review with NCD or LCD (Preauthorization required)
Effective 01/01/2025

Codes Applied to Policy

Purpose

The purpose of this document is to provide a step-by-step process of the Utilization Management review for Medicare Part B.

Definitions

Policy

For 2024, a minimum 90-day transition period shall be provided when an enrollee who is currently undergoing an active course of treatment switches to a new Medicare Advantage (MA) plan.

Utilization management review for Medicare Part B occurs via a stepwise approach as follows:

1. Determination of “reasonable and necessary”
   1. Refer to the Medicare Coverage Database (MCD) for a national coverage determination (NCD) or local coverage determination (LCD) from the Medicare Administrative Contractor (MAC) for the jurisdiction
   2. In the absence of an NCD or LCD, the FDA-approved product label is referenced for ALL of the following:
      1. Indication (including age restrictions)
      2. Dose and frequency
      3. Duration of therapy (if limited)
      4. Boxed warnings
      5. Contraindications (with the exception of hypersensitivity to the requested product)
      6. Warnings and Precautions (with the exception of those which would only become apparent/applicable upon receipt of the product as this occurs subsequent to the pre-service determination)
   3. Off-label use (inclusive of dose, frequency, and duration) reference the following:
      1. Oncology
         1. CMS-supported compendia (i.e., NCCN, Clinical Pharmacology, Lexicomp Lexi-Drugs, Micromedex DrugDex (Merative Micromedex), & AHFS-DI) or published peer-reviewed literature
      2. Non-Oncology
         1. CMS-supported compendia (i.e., NCCN, Clinical Pharmacology, Lexicomp Lexi-Drugs, Micromedex DrugDex (Merative Micromedex), & AHFS-DI), authoritative medical literature and/or accepted standards of medical practice
2. Once “reasonable and necessary” has been determined, refer to the Medicare Part B Step Therapy document for preferred agents (as applicable).
   1. Exceptions to step therapy include any of the following:
      1. Use of the non-preferred product in the preceding 365 days.
      2. Documented failure, contraindication, or intolerance to [CLIENT- specific: all, one, two, etc.] preferred products.
      3. Documentation that all preferred products are likely to be ineffective or cause an adverse reaction.
      4. The medically accepted indication for use is not shared amongst products by either FDA labeling or CMS-recognized compendia or clinical literature.
3. The authorization validity period for 2024 must conform to that specified by CMS or the MAC. In the absence of such, it shall be determined based upon the prescriber’s anticipated course of therapy, unless there is a superseding limitation to the duration in the source used to determine reasonable and necessary (refer to 1.b. and 1.c. above). Prior to 2024, the validity period is at the discretion of the MAO (Medicare Advantage Organization).
4. Requests for continuation of therapy shall assess beneficial response to therapy and the absence of unacceptable toxicities for a medically accepted indication.
5. The clinician reviewer considers all relevant aspects of the case and patient-specifics when making the determination. The clinician reviewer may exercise clinical judgment and apply it to the pre-service determination. Such applications will be clearly documented in the case file notes.

Related Policies

Related Procedures

• MA Part B Utilization Management in the Absence of NCD or LCD (MUM-97)