The requested Part B medication will be approved when BOTH of the following are met:

1. ONE of the following:
   1. There is an applicable national coverage determination (NCD) or local coverage determination (LCD) from the Medicare Administrative Contractor (MAC) for the jurisdiction and the patient meets all of the requirements listed within the NCD or LCD
      OR
   2. There is NOT an applicable NCD or LCD and the requested medication is being used according to FDA labeling or in accordance with a CMS supported compendia (i.e., NCCN, Clinical Pharmacology, Lexicomp Lexi-Drugs, Merative Micromedex, & AHFS-DI) or published peer-reviewed literature
      AND
2. ONE of the following:
   1. The requested medication is being evaluated for approval for the first time
      OR
   2. The request is for continuation of therapy and the patient has shown beneficial response to therapy

Length of Approval: See Table 1 below

Notes:

• Length of approval may be shorter due to provider network participation status.

*See separate medical drug policies for the following drugs: Amvuttra, Onpattro and Oxlumo.

August 2024: Coding change: Added HCPCS codes J1599 for Alyglo effective 8/1/24;

Added HCPCS codes G2082/G2083 for Spravato effective 8/1/24;

Added HCPCS code J9333 for Rystiggo effective 8/1/24.

Added Udenyca Onbody to HCPCS code Q5111 effective 8/1/24.

Removed HCPCS code J1566 for Carimune NF effective 8/26/24.