Part B Step Therapy Criteria for Approval

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 for an FDA approved indication 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. Information has been provided that indicates the patient has been treated with the requested medication in the past 365 days
      OR
      
   2. There is documentation that the patient has had an ineffective treatment response to the active ingredient(s) of ALL* preferred medications supported for the diagnosis
      OR
      
   3. The patient has a documented intolerance, hypersensitivity, or FDA labeled contraindication to the active ingredient(s) of ALL preferred medications supported for the diagnosis       OR
   4. The prescriber has submitted documentation indicating ALL preferred medications supported for the diagnosis are likely to be ineffective or are likely to cause an adverse reaction or other harm to the patient

Length of Approval: See Table 1 below

*Unless otherwise noted in the preferred medications column of Table 1

NOTES:

• Preferred medication is not required if the indication is not shared by the non-preferred medication in supported compendia or clinical literature.
• Preferred medications may require prior review under Medicare Part D or Medicare Part B. Medicare Part D preferred medications will not be required for Medical Only members.
• Length of approval may be shorter due to provider network participation status.
• Coverage of one Medicare Part B Step Therapy medication could equate to multiple medication authorizations when they share the same Medicare Part B Step Therapy criteria.

**This list is subject to change.

***These products do not require review for patients on dialysis when submitted for reimbursement as part of the End Stage Renal Disease (ESRD) Prospective Payment System (PPS), or “bundled” PPS amount.

Revision History

12/2/2024: 

• Soliris
  • Added Vyvgart Hytrulo as a preferred medication
• Bevacizumab (Oncology)
  • Added HCPCS code Q5129 for Vegzelma
• Long-Acting Colony Stimulating Factors
  • Added HCPCS code Q5130 for Fylnetra
  • Added HCPCS code Q5127 for Stimufend    

12/11/2024

• Changed formulary (Preferred and Nonpreferred medications) for the following drug classes: 
  • Ocular Angiogenesis Inhibitors
    • Added Byooviz, Cimerli, Lucentis, Vabysmo, Eylea, Eylea HD to the Non-Preferred Medication(s) Step 2 column for Beovu and Susvimo
  • Trastuzumab
    • Removed Ogivri from Preferred Medications and added to nonpreferred medications; Added Trazimera to Preferred Medications;
  • Long-Acting Colony Stimulating Factors 
    • Removed Udenyca and Ziextenzo from Preferred Medications and added to nonpreferred medications; Added Fulphila and Nyvepria to Preferred Medications
  • Immune Globulin (SC)
    • Added HCPCS code J1555 for Cuvitru
  • Immune Globulin (IV)
    • Added HCPCS code J1557 for Gammaplex
    • Added HCPCS code J1576 for Panzyga
    • Added HCPCS code J1556 for Bivigam
    • Added HCPCS code J1554 for Asceniv
    • Added HCPCS code J1599 for Alyglo
    • Added HCPCS code J1572 for Flebogamma

3/27/2025

• Soliris
  • Added HCPCS code J1299 effective 4/1/2025; deleted J1300 termed 3/31/2025