MA Part B Utilization Management in the Absence of NCD or LCD Policy Number M.16

Medical benefit drug policies are a source for Blue Cross and Blue Shield of Nebraska Medicare Advantage medical policy information only. These documents are not to be used to determine benefits or reimbursement. Please reference the appropriate certificate or contract for benefit information. This policy may be updated and therefore subject to change. 
 
Policy Number M.16 
MA Part B Utilization Management in the Absence of NCD or LCD (Preauthorization Required)
Effective 01/01/2025 Version 1

Codes Applied to Policy

Purpose

The purpose of this document is to provide a detailed account of the process for applying utilization management to Medicare Part B-eligible pharmaceutical products in the absence of an LCD or NCD.

Definitions

Policy

CMS Guidance

1. Pub. 100-16, Chapter 4, Sec. 10.2 Basic Rule, Medicare coverage and payment is contingent upon a determination that:
   1. A service is in a covered benefit category;
   2. A service is not specifically excluded from Medicare coverage by the Act; and
   3. The item or service is “reasonable and necessary” for the diagnosis or treatment of an illness or injury, to improve the functioning of a malformed body member, or is a covered preventive service.
2. Pub. 100-16, Chapter 4, Sec. 10.16 Medical Necessity (42 CFR §422.112(a)(6)(ii)); MA organizations must establish written standards for policies and procedures (coverage rules, practice guidelines, payment policies, and utilization management) that allow for individual medical necessity determination.
3. Pub. 100-16, Chapter 4, Sec. 90.1 National and Local Coverage Determination Overview; an item or service classified as an original Medicare benefit must be covered by every MA plan if:
   1. Its coverage is consistent with general coverage guidelines included in original Medicare regulations, manuals, and instructions (unless superseded by written CMS instructions or regulations regarding Part C of the Medicare program)
   2. It is covered by CMS’s national coverage determinations (see sections 90.3 and 90.4, below); or
   3. It is covered by written coverage decisions of local Medicare Administrative Contractors (MACs) with jurisdiction for claims in the geographic area in which services are covered under the MA plan, as described in section 90.2 below.
4. Pub. 100-16, Chapter 4, Sec. 90.5 Creating New Guidance, in coverage situations where there is no NCD, LCD, or guidance on coverage in original Medicare manuals, an MA organization:
   1. May adopt the coverage policies of other MAOs in its service area; OR
   2. Must make its own coverage determination and provide CMS an objective evidence-based rationale relying on authoritative evidence.
5. 2024 Medicare Advantage and Part D Final Rule (CMS-4201-F) specifies that all MA plans establish a Utilization Management Committee to review all utilization management, including prior authorization, policies annually and ensure they are consistent with the coverage requirements, including current, traditional Medicare’s national and local coverage decisions and guidelines. Refer to § 422.137 Medicare Advantage Utilization Management Committee

Application of Guidance

1. Pursuant to A.3.b. and A.3.c. above, the respective CMS coverage determinations are referenced (if available) in determining A.1.a through A.1.c. above (these may be found at www.cms.gov/medicare-coverage-database/new-search/search.aspx).
   1. Per Pub. 100-16, Chapter 4, Sec. 90.4.2 Multiple A/B MACs with Different Policies, the coverage policy with jurisdiction over the state in which the service is furnished to the enrollee is applied, OR
   2. The MA plan adopts a uniform coverage policy for all enrollees which is subsequently communicated to CMS (CMS approval is required for local, but not regional, MA plans).
      1. Upon plan direction, the specified uniform coverage policy is applied to providers within the plan’s service area.
      2. For providers not within the plan’s service area, local coverage determination based on the provider’s geographic location is used per B.1.a. above; OR
2. Pursuant to A.3.a. above, in the absence of superseding written CMS instructions or regulations regarding Part C of the Medicare program, original Medicare manual Pub. 100-02, Chapter 15, Sec. 50 Drugs and Biologicals is applied.
   1. Pub. 100-02, Chapter 15, Sec. 50.4.1 Approved Use of Drug: Drugs or biologicals approved for marketing by the Food and Drug Administration (FDA) are considered safe and effective for purposes of this requirement when used for indications specified on the labeling. Therefore, the program may pay for the use of an FDA-approved drug or biological, if:
      1. It was injected on or after the date of the FDA’s approval.
      2. It is reasonable and necessary for the individual patient; and
      3. All other applicable coverage requirements are met, OR
   2. Medicare Part B does not cover drugs that are usually self-administered by the patient pursuant to Pub. 100-02, Chapter 15, Sec. 50.2 unless the statute provides for such coverage pursuant to Pub. 100-02, Chapter 15, Sec. 50.5.
      1. Refer to Pub. 100-02, Chapter 15, Sec. 50.5.1 through 50.5.5 for statutorily covered self[1]administered drugs.
      2. Refer to Pub. 100-02, Chapter 15, Sec. 50.2 for determining if a drug or biological meets the requirement under Part B that they are not usually self-administered by the patient.
         1. Additionally, MACs may publish a self-administered drug exclusions list LCA to provide guidance.
   3. Off-label use of drugs and biologicals in an anti-cancer chemotherapeutic regimen is covered pursuant to Pub. 100-02, Chapter 15, Sec. 50.4.5. Off-label, medically accepted indications are supported in either one or more of the compendia or in peer-reviewed medical literature. In general, use is identified by a compendium as medically accepted if:
      1. The indication is a Category 1 or 2A in NCCN, or Class I, Class IIa, or Class IIb in DrugDex (Merative Micromedex); or,
      2. Narrative text in AHFS-DI or Clinical Pharmacology is supportive, or
      3. The indication is listed in Lexi-Drugs as “Use: Off-Label” and rated as “Evidence Level A”
      A use is not medically accepted by a compendium if:
      1. The indication is a Category 3 in NCCN or a Class III in DrugDex (Merative Micromedex); or,
      2. Narrative text in AHFS or Clinical Pharmacology is “not supportive,” or
      3. The indication is listed in Lexi-Drugs as “Use: Unsupported”
   The complete absence of narrative text on a use is considered neither supportive nor non-supportive.
   Note: Requests for NCCN category 2B indications will be evaluated based upon medical necessity on a case-by-case basis; OR
   4. Off-label use of drugs and biologicals NOT in an anti-cancer chemotherapeutic regimen is evaluated according to A.4. above:
      1. Per A.4.a., the MA plan adopts the coverage policies of other MAOs in its service area; OR
      2. Per A.4.b., the MA plan must make its own coverage determination. In this instance, the MAO does one of the following:
         1. Adopts the coverage policies for off-label uses from another MAC: L33394 (NGS; Jurisdiction 6) if within its service area (MAC service areas may be found at:
            www.cms.gov/Medicare/Medicare-Contracting/Medicare-Administrative[1]Contractors/Who-are-the-MACs); OR
         2. Determines coverage for medically accepted use by following the process described for determining coverage under Medicare used by the A/B MAC (B) per Pub. 100-02, Chapter 15, Sec. 50.4.2 Unlabeled Use of Drug, which provides for taking into consideration the major drug compendia, authoritative medical literature and/or accepted standards of medical practice. Support in one or more compendia is defined as follows:
            1. The indication is a Category 1 or 2A in NCCN, or Class I, Class IIa, or Class IIb in DrugDex (Merative Micromedex); OR
            2. Note: Requests for NCCN category 2B indications will be evaluated based upon medical necessity on a case-by-case basis
            3. Narrative text in AHFS-DI or Clinical Pharmacology is supportive, OR
            4. The indication is listed in Lexi-Drugs as “Use: Off-Label” and rated as “Evidence Level A”; OR
         3. Determines coverage for medically accepted use based upon the Plan’s clinical criteria for other non-Medicare lines of business.
3. Pursuant to A.5. above, for 2024, each MA Plan must establish a Utilization Management Committee to review all utilization management, including prior authorization, policies annually and ensure they are consistent with the coverage requirements, including current, traditional Medicare national and local coverage decisions and guidelines.

Procedure for PA Review

Utilization management review and determination of “reasonable and necessary” in the absence of an NCD or local coverage document from the MAC, occurs via the Medicare Part B Utilization Management Review document.

• CMS-4201-F §422.112(b)(8) specifies 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 MA plan.
  • The authorization validity period must conform to that specified by CMS or the MAC. In the absence of such, it shall be determined based upon the anticipated course of therapy, unless there is a superseding limitation to the duration within the FDA prescribing information.

Note:
The above may in whole or in part, at the discretion of MRxM, be incorporated into a decision-support tool to assist in the expedient collection of pertinent information for favorable coverage determination (Note: adverse coverage determination cannot be rendered by a decision-support tool).