Part B Step Therapy Criteria for Approval
Part B Step Therapy Criteria for Approval
The requested Part B medication will be approved when BOTH of the following are met:
- ONE of the following:
- 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
- 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
- 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
- ONE of the following:
- Information has been provided that indicates the patient has been treated with the requested medication in the past 365 days
OR
- 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
- 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
- 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
- Information has been provided that indicates the patient has been treated with the requested medication in the past 365 days
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
HCPCS | Medication | Preferred Medication(s)** | Length of Approval | NCD/LCD |
---|---|---|---|---|
J2786 | Cinqair | For severe asthma aged 18 years and older with eosinophilic phenotype: Part D formulary inhaled corticosteroid | 12 months | N/A |
J0517 | Fasenra | For severe asthma aged 18 years and older with eosinophilic phenotype: Part D formulary inhaled corticosteroid | 12 months | N/A |
J2182 | Nucala | For severe asthma aged 18 years and older with eosinophilic phenotype: Part D formulary inhaled corticosteroid | 12 months | N/A |
Xolair
HCPCS | Medication | Preferred Medication(s)** | Length of Approval | NCD/LCD |
---|---|---|---|---|
J2357 | Xolair | For moderate to severe persistent asthma aged 18 years and older: Part D formulary inhaled corticosteroid | 12 months | N/A |
Tezspire
HCPCS | Medication | Preferred Medication(s)** | Length of Approval | NCD/LCD |
---|---|---|---|---|
J2356 | Tezspire | Part D formulary inhaled corticosteroid | 12 months | N/A |
Ocular Angiogenesis Inhibitors
HCPCS | Medication | Preferred Medication(s)** Step 1 | Non-Preferred Medication(s)** Step 2 | Length of Approval | NCD/LCD |
---|---|---|---|---|---|
J0179 | Beovu | (Part B) Avastin | Byooviz, Cimerli, Lucentis, Vabysmo, Eylea, Eylea HD | 12 months | N/A |
Q5124 | Byooviz | (Part B) Avastin | 12 months | N/A | |
Q5128 | Cimerli | (Part B) Avastin | 12 months | N/A | |
J0178 | Eylea | (Part B) Avastin | 12 months | N/A | |
J0177 | Eylea HD | (Part B) Avastin | 12 months | N/A | |
J2778 | Lucentis | (Part B) Avastin | 12 months | N/A | |
J2779 | Susvimo | (Part B) Avastin | Byooviz, Cimerli, Lucentis, Vabysmo, Eylea, Eylea HD | 12 months | N/A |
J2777 | Vabysmo | (Part B) Avastin | 12 months | N/A |
Healthcare Administered MS Agents
HCPCS | Medication | Preferred Medication(s)** | Length of Approval | NCD/LCD |
---|---|---|---|---|
J0202 | Lemtrada | TWO of the following: (Part D) Avonex, Betaseron, dimethyl fumarate, fingolimod, glatiramer (brand names Copaxone and Glatopa), Mayzent, Plegridy, Vumerity | 12 months | N/A |
J2350 | Ocrevus | TWO of the following: (Part D) Avonex, Betaseron, dimethyl fumarate, fingolimod, glatiramer (brand names Copaxone and Glatopa), Mayzent, Plegridy, Vumerity | 12 months | N/A |
J2323 | Tysabri | For 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 months | N/A |
Intra-articular Hyaluronan Injections
HCPCS | Medication | Preferred Medication(s)** | Length of Approval | NCD/LCD |
---|---|---|---|---|
J7318 | Durolane | (Part B) Orthovisc, Synvisc/Synvisc One | 6 months | L39260 |
J7323 | Euflexxa | (Part B) Orthovisc, Synvisc/Synvisc One | 6 months | L39260 |
J7326 | Gel-One | (Part B) Orthovisc, Synvisc/Synvisc One | 6 months | L39260 |
J7328 | Gelsyn-3 | (Part B) Orthovisc, Synvisc/Synvisc One | 6 months | L39260 |
J7320 | GenVisc 850 | (Part B) Orthovisc, Synvisc/Synvisc One | 6 months | L39260 |
J7321 | Hyalgan | (Part B) Orthovisc, Synvisc/Synvisc One | 6 months | L39260 |
J7322 | Hymovis | (Part B) Orthovisc, Synvisc/Synvisc One | 6 months | L39260 |
J7327 | Monovisc | (Part B) Orthovisc, Synvisc/Synvisc One | 6 months | L39260 |
J7321 | Supartz FX | (Part B) Orthovisc, Synvisc/Synvisc One | 6 months | L39260 |
J7332 | Triluron | (Part B) Orthovisc, Synvisc/Synvisc One | 6 months | L39260 |
J7329 | TriVisc | (Part B) Orthovisc, Synvisc/Synvisc One | 6 months | L39260 |
J7321 | Visco-3 | (Part B) Orthovisc, Synvisc/Synvisc One | 6 months | L39260 |
IV Iron Agents
HCPCS | Medication | Preferred Medication(s)** | Length of Approval | NCD/LCD |
---|---|---|---|---|
J1439 | Injectafer (ferric carboxymaltose)*** | TWO of the following: (Part B) Venofer (iron sucrose), INFeD (iron dextran), Ferrlecit (sodium ferric gluconate complex), Feraheme (ferumoxytol), ferumoxytol | 12 months | N/A |
J1437 | Monoferric (ferric derisomaltose)*** | TWO of the following: (Part B) Venofer (iron sucrose), INFeD (iron dextran), Ferrlecit (sodium ferric gluconate complex), Feraheme (ferumoxytol), ferumoxytol | 12 months | N/A |
Bevacizumab (Oncology)
HCPCS | Medication | Preferred Medication(s)** | Length of Approval | NCD/LCD |
---|---|---|---|---|
Q5126 | Alymsys | Mvasi, Zirabev | 12 months | N/A |
J9035 | Avastin | Mvasi, Zirabev (only for oncology indications) | 12 months | N/A |
Q5129 | Vegzelma | Mvasi, Zirabev | 12 months | N/A |
Trastuzumab
HCPCS | Medication | Preferred Medication(s)** | Length of Approval | NCD/LCD |
---|---|---|---|---|
J9355 | Herceptin | Kanjinti, Trazimera | 12 months | N/A |
J9356 | Herceptin Hylecta | Kanjinti, Trazimera | 12 months | N/A |
Q5113 | Herzuma | Kanjinti, Trazimera | 12 months | N/A |
Q5112 | Ontruzant | Kanjinti, Trazimera | 12 months | N/A |
Q5114 | Ogivri | Kanjinti, Trazimera | 12 months | N/A |
Rituximab
HCPCS | Medication | Preferred Medication(s)** | Length of Approval | NCD/LCD |
---|---|---|---|---|
Q5123 | Riabni | Ruxience, Truxima | 12 months | L35026 |
J9312 | Rituxan | Ruxience, Truxima | 12 months | L35026 |
J9311 | Rituxan Hycela | Ruxience, Truxima | 12 months | L35026 |
Long-Acting Colony Stimulating Factors
HCPCS | Medication | Preferred Medication(s)** | Length of Approval | NCD/LCD |
---|---|---|---|---|
Q5130 | Fylnetra | Fulphila, Nyvepria | 12 months | A56748 |
J2506 | Neulasta, Neulasta OnPro | Fulphila, Nyvepria | 12 months | L37176 |
J1449 | Rolvedon | Fulphila, Nyvepria | 12 months | A56748 |
Q5127 | Stimufend | Fulphila, Nyvepria | 12 months | A56748 |
Q5111 | Udenyca/Udenyca Onbody | Fulphila, Nyvepria | 12 months | A56748 |
Q5120 | Ziextenzo | Fulphila, Nyvepria | 12 months | A56748 |
Short-Acting Colony Stimulating Factors
HCPCS | Medication | Preferred Medication(s)** | Length of Approval | NCD/LCD |
---|---|---|---|---|
J1447 | Granix | Zarxio, Nivestym | 12 months | L37176 |
Q5125 | Releuko | Zarxio, Nivestym | 12 months | L37176 |
J1442 | Neupogen | Zarxio, Nivestym | 12 months | L37176 |
Complement C5 Inhibitors
HCPCS | Medication | Preferred Medication(s)** | Length of Approval | NCD/LCD |
---|---|---|---|---|
J1300 | Soliris | For 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, Uplizna | 12 months | N/A |
Infliximab
HCPCS | Medication | Preferred Medication(s)** | Length of Approval | NCD/LCD |
---|---|---|---|---|
J1745 | Remicade | (Part B) Avsola, Inflectra | 12 months | L35677 |
Q5104 | Renflexis | (Part B) Avsola, Inflectra | 12 months | L35677 |
Immune Globulin (SC)
HCPCS | Medication | Preferred Medication(s)** | Length of Approval | NCD/LCD |
---|---|---|---|---|
J1555 | Cuvitru | HyQvia, Hizentra, Xembify, Cutaquiq | 12 months | L33794 |
Immune Globulin (IV)
HCPCS | Medication | Preferred Medication(s)** | Length of Approval | NCD/LCD |
---|---|---|---|---|
J1599 | Alyglo | Gammagard, Gammaked, Gamunex-C, Octagam, Privigen | 12 months | A56718 L34580 |
J1554 | Asceniv | Gammagard, Gammaked, Gamunex-C, Octagam, Privigen | 12 months | L34580 |
J1556 | Bivigam | Gammagard, Gammaked, Gamunex-C, Octagam, Privigen | 12 months | L34580 |
J1572 | Flebogamma | Gammagard, Gammaked, Gamunex-C, Octagam, Privigen | 12 months | L34580 |
J1557 | Gammaplex | Gammagard, Gammaked, Gamunex-C, Octagam, Privigen | 12 months | L34580 |
J1576 | Panzyga | Gammagard, Gammaked, Gamunex-C, Octagam, Privigen | 12 months | L34580 |
**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
- Ocular Angiogenesis Inhibitors
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