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Part B Step Therapy Criteria for Approval

Medicare Policy
Policy Effective: 03/03/2025

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.

Table 1: Part B Step Therapy

IL-5 Inhibitors

HCPCSMedicationPreferred Medication(s)**Length of ApprovalNCD/LCD
J2786CinqairFor severe asthma aged 18 years and older with eosinophilic phenotype: Part D formulary inhaled corticosteroid12 monthsN/A
J0517FasenraFor severe asthma aged 18 years and older with eosinophilic phenotype: Part D formulary inhaled corticosteroid12 monthsN/A
J2182NucalaFor severe asthma aged 18 years and older with eosinophilic phenotype: Part D formulary inhaled corticosteroid12 monthsN/A

Xolair

HCPCSMedicationPreferred Medication(s)**Length of ApprovalNCD/LCD
J2357XolairFor moderate to severe persistent asthma aged 18 years and older: Part D formulary inhaled corticosteroid12 monthsN/A

Tezspire

HCPCSMedicationPreferred Medication(s)**Length of ApprovalNCD/LCD
J2356Tezspire Part D formulary inhaled corticosteroid12 monthsN/A

Ocular Angiogenesis Inhibitors

HCPCSMedication

Preferred Medication(s)** 

Step 1

Non-Preferred Medication(s)**

Step 2

Length of ApprovalNCD/LCD
J0179Beovu(Part B) AvastinByooviz, Cimerli, Lucentis, Vabysmo, Eylea, Eylea HD12 monthsN/A
Q5124Byooviz(Part B) Avastin 12 monthsN/A
Q5128Cimerli(Part B) Avastin 12 monthsN/A
J0178Eylea(Part B) Avastin 12 monthsN/A
J0177Eylea HD(Part B) Avastin 12 monthsN/A
J2778Lucentis(Part B) Avastin 12 monthsN/A
J2779Susvimo(Part B) AvastinByooviz, Cimerli, Lucentis, Vabysmo, Eylea, Eylea HD12 monthsN/A
J2777Vabysmo(Part B) Avastin 12 monthsN/A

Healthcare Administered MS Agents

HCPCSMedicationPreferred Medication(s)**Length of ApprovalNCD/LCD
J0202LemtradaTWO of the following: (Part D) Avonex, Betaseron, dimethyl fumarate, fingolimod, glatiramer (brand names Copaxone and Glatopa), Mayzent, Plegridy, Vumerity12 monthsN/A
J2350OcrevusTWO of the following: (Part D) Avonex, Betaseron, dimethyl fumarate, fingolimod, glatiramer (brand names Copaxone and Glatopa), Mayzent, Plegridy, Vumerity12 monthsN/A
J2323TysabriFor MS, TWO of the following: (Part D) Avonex, Betaseron, dimethyl fumarate, fingolimod, glatiramer (brand names Copaxone and Glatopa), Mayzent, Plegridy, Vumerity;
For Crohn's Disease ONE of the following: (Part D) Corticosteroids, methotrexate, and immunomodulators such as azathioprine or 6-mercaptopurine
12 monthsN/A

Intra-articular Hyaluronan Injections

HCPCSMedicationPreferred Medication(s)**Length of ApprovalNCD/LCD
J7318Durolane(Part B) Orthovisc, Synvisc/Synvisc One6 monthsL39260
J7323Euflexxa(Part B) Orthovisc, Synvisc/Synvisc One6 monthsL39260
J7326Gel-One(Part B) Orthovisc, Synvisc/Synvisc One6 monthsL39260
J7328Gelsyn-3(Part B) Orthovisc, Synvisc/Synvisc One6 monthsL39260
J7320GenVisc 850(Part B) Orthovisc, Synvisc/Synvisc One6 monthsL39260
J7321Hyalgan(Part B) Orthovisc, Synvisc/Synvisc One6 monthsL39260
J7322Hymovis(Part B) Orthovisc, Synvisc/Synvisc One6 monthsL39260
J7327Monovisc(Part B) Orthovisc, Synvisc/Synvisc One6 monthsL39260
J7321Supartz FX(Part B) Orthovisc, Synvisc/Synvisc One6 monthsL39260
J7332Triluron(Part B) Orthovisc, Synvisc/Synvisc One6 monthsL39260
J7329TriVisc(Part B) Orthovisc, Synvisc/Synvisc One6 monthsL39260
J7321Visco-3(Part B) Orthovisc, Synvisc/Synvisc One6 monthsL39260

IV Iron Agents

HCPCSMedication

Preferred

Medication(s)**   

Length of ApprovalNCD/LCD
J1439Injectafer (ferric carboxymaltose)***TWO of the following: (Part B) Venofer (iron sucrose), INFeD (iron dextran), Ferrlecit (sodium ferric gluconate complex), Feraheme (ferumoxytol), ferumoxytol12 monthsN/A
J1437Monoferric (ferric derisomaltose)***TWO of the following: (Part B) Venofer (iron sucrose), INFeD (iron dextran), Ferrlecit (sodium ferric gluconate complex), Feraheme (ferumoxytol), ferumoxytol12 monthsN/A

Bevacizumab (Oncology)

HCPCSMedication

Preferred

Medication(s)**   

Length of ApprovalNCD/LCD
Q5126AlymsysMvasi, Zirabev12 monthsN/A
J9035AvastinMvasi, Zirabev (only for oncology indications)12 monthsN/A
Q5129VegzelmaMvasi, Zirabev12 monthsN/A

Trastuzumab

HCPCSMedicationPreferred Medication(s)**Length of ApprovalNCD/LCD
J9355HerceptinKanjinti, Trazimera12 monthsN/A
J9356Herceptin HylectaKanjinti, Trazimera12 monthsN/A
Q5113HerzumaKanjinti, Trazimera12 monthsN/A
Q5112OntruzantKanjinti, Trazimera12 monthsN/A
Q5114OgivriKanjinti, Trazimera12 monthsN/A

Rituximab

HCPCSMedication

Preferred

Medication(s)**   

Length of ApprovalNCD/LCD
Q5123RiabniRuxience, Truxima12 monthsL35026
J9312RituxanRuxience, Truxima12 monthsL35026
J9311Rituxan HycelaRuxience, Truxima12 monthsL35026

Long-Acting Colony Stimulating Factors

HCPCSMedication

Preferred

Medication(s)**  

Length of ApprovalNCD/LCD
Q5130FylnetraFulphila, Nyvepria12 monthsA56748
J2506Neulasta, Neulasta OnProFulphila, Nyvepria12 monthsL37176
J1449RolvedonFulphila, Nyvepria12 monthsA56748
Q5127StimufendFulphila, Nyvepria12 monthsA56748
Q5111Udenyca/Udenyca OnbodyFulphila, Nyvepria12 monthsA56748
Q5120ZiextenzoFulphila, Nyvepria12 monthsA56748

Short-Acting Colony Stimulating Factors

HCPCSMedication

Preferred

Medication(s)**   

Length of ApprovalNCD/LCD
J1447GranixZarxio, Nivestym12 monthsL37176
Q5125ReleukoZarxio, Nivestym12 monthsL37176
J1442NeupogenZarxio, Nivestym12 monthsL37176

Complement C5 Inhibitors

HCPCSMedication

Preferred

Medication(s)**   

Length of ApprovalNCD/LCD
J1300SolirisFor Paroxysmal nocturnal hemoglobinuria: Ultomiris, Empaveli; For atypical hemolytic uremic syndrome: Ultomiris; For generalized myasthenia gravis: Ultomiris, Vyvgart, Vyvgart Hytrulo; For neuromyelitis optica spectrum disorder: Enspryng, Uplizna12 monthsN/A

Infliximab

HCPCSMedication

Preferred

Medication(s)**   

Length of ApprovalNCD/LCD
J1745Remicade(Part B) Avsola, Inflectra12 monthsL35677
Q5104Renflexis(Part B) Avsola, Inflectra12 monthsL35677

Immune Globulin (SC)

HCPCSMedication

Preferred

Medication(s)**   

Length of ApprovalNCD/LCD
J1555CuvitruHyQvia, Hizentra, Xembify, Cutaquiq12 monthsL33794 

Immune Globulin (IV)

HCPCSMedication

Preferred

Medication(s)**   

Length of ApprovalNCD/LCD
J1599AlygloGammagard, Gammaked, Gamunex-C, Octagam, Privigen12 months

A56718

L34580

J1554AscenivGammagard, Gammaked, Gamunex-C, Octagam, Privigen12 monthsL34580
J1556BivigamGammagard, Gammaked, Gamunex-C, Octagam, Privigen12 monthsL34580
J1572Flebogamma Gammagard, Gammaked, Gamunex-C, Octagam, Privigen12 monthsL34580
J1557GammaplexGammagard, Gammaked, Gamunex-C, Octagam, Privigen12 monthsL34580
J1576PanzygaGammagard, Gammaked, Gamunex-C, Octagam, Privigen12 monthsL34580

**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