MA Part B Step Therapy for Outpatient Medications Policy Number M.18
Medicare Advantage
Policy Number: MA-X-076
Last Updated: Dec. 18, 2024
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.18
MA Part B Step Therapy for Outpatient Medications
Effective 01/01/2025
Codes Applied to Policy
HCPCS | Brand Name | Generic Name |
J1552 | Alyglo | intravenous immune globulin |
Q5126 | Alymsys | bevacizumab-maly |
J1554 | Asceniv | intravenous immune globulin |
J9035 | Avastin | bevacizumab |
Q5121 | Avsola | infliximab-axxq |
J9999 | Avzivi | Bevacizumab-tnjn |
J0179 | Beovu | brolucizumab-dbll |
J1556 | Bivigam | intravenous immune globulin |
Q5124 | Byooviz | ranibizumab-nuna |
Q5128 | Cimerli | ranibizumab-eqrn |
J1551 | Cutaquig | subcutaneous immune globulin |
J1555 | Cuvitru | subcutaneous immune globulin |
J7318 | Durolane | hyaluronan or derivative |
J7323 | Euflexxa | hyaluronan or derivative |
J0178 | Eylea | aflibercept |
J0177 | Eylea HD | aflibercept |
Q0138 | Feraheme | |
J2916 | Ferlicit | |
J1572 | Flebogamma | intravenous immune globulin |
Q5108 | Fulphila | pegfilgrastim-cbqv |
Q5130 | Fylnetra | pegfilgrastim-pbbk |
J1569 | Gammagard Liquid | intravenous immune globulin |
J1566 | Gammagard S/D | intravenous immune globulin |
J1561 | Gammaked | intravenous immune globulin |
J1557 | Gammaplex | intravenous immune globulin |
J1561 | Gamunex-C | intravenous immune globulin |
J7326 | Gel-One | hyaluronan or derivative |
J7328 | Gelsyn-3 | hyaluronan or derivative |
J7320 | Genvisc 850 | hyaluronan or derivative |
J9355 | Herceptin | trastuzumab |
J9356 | Herceptin Hylecta | trastuzumab-hyaluronidase-oysk |
Q5146 | Hercessi | trastuzumab-strf |
Q5113 | Herzuma | trastuzumab-pkrb |
J1559 | Hizentra | subcutaneous immune globulin |
J7321 | Hyalgan | hyaluronan or derivative |
J7322 | Hymovis | hyaluronan or derivative |
J1575 | Hyqvia | subcutaneous immune globulin |
J3590 | Imuldosa IV | |
J1750 | Infed | |
Q5103 | Inflectra | infliximab-dyyb |
J1745 | Infliximab unbranded | infliximab |
J1439 | Injectafer | ferric carboxymaltose |
J1599;J1566 | Immune Globulin (Intravenous) | intravenous immune globulin |
J3590 | Immune Globulin (Subcutaneous) | |
Q5117 | Kanjinti | trastuzumab-anns |
J2778 | Lucentis | ranibizumab |
J1437 | Monoferric | ferric derisomaltose |
J7327 | Monovisc | hyaluronan or derivative |
Q5107 | Mvasi | bevacizumab-awwb |
J2506 | Neulasta | pegfilgrastim |
Q5122 | Nyvepria | pegfilgrastim-apgf |
J1568 | Octagam | intravenous immune globulin |
Q5114 | Ogivri | trastuzumab-dkst |
Q5112 | Ontruzant | trastuzumab-dttb |
J7324 | Orthovisc | hyaluronan or derivative |
J3590 | Otulfi IV | |
J1576 | Panzyga | intravenous immune globulin |
J3590 | Pavblu | |
J1307 | Piasky | |
J1459 | Privigen | intravenous immune globulin |
J3590 | Pyzchiva | |
J1745 | Remicade | infliximab |
Q5104 | Renflexis | infliximab-abda |
Q5123 | Riabni | rituximab-arrx |
J9312 | Rituxan | rituximab |
J9311 | Rituxan Hycela | rituximab and hyaluronidase human |
J1449 | Rolvedon | eflapegrastim-xnst |
Q5119 | Ruxience | rituximab-pvvr |
J9333 | Rystiggo | rozanolixizumab-noli |
J1300 | Soliris | |
J3358 | Stelera IV | |
Q5127 | Stimufend | pegfilgrastim-fpgk |
J3590 | Subcutaneous Immune Globulin | subcutaneous immune globulin |
J7321 | Supartz | hyaluronan or derivative |
J2779 | Susvimo | ranibizumab |
J7331 | Synojoynt | hyaluronan or derivative |
J7325 | Synvisc | hyaluronan or derivative |
J7325 | Synvisc-One | hyaluronan or derivative |
Q5116 | Trazimera | trastuzumab-qyyp |
J7332 | Triluron | Sodium Hyaluronate |
J7329 | TriVisc | hyaluronan or derivative |
Q5115 | Truxima | rituximab-abbs |
Q5111 | Udenyca | pegfilgrastim-jmdb |
J1303 | Ultomiris | ravulizumab-cwvz |
J2777 | Vabysmo | faricimab-svoa |
Q5129 | Vegzelma | bevacizumab-adcd |
J1756 | Venofer | |
J7321 | Visco-3 | hyaluronan or derivative |
J9332 | Vyvgart | efgartigimod alfa-fcab |
J9334 | Vyvgart Hytrulo | efgartigimod alfa hyaluronidase-qvfc |
Q5138 | Wezlana IV | |
J1558 | Xembify | subcutaneous immune globulin |
Q5120 | Ziextenzo | pegfilgrastim-bmez |
Q5118 | Zirabev | bevacizumab-bvzr |
Policy
Step Therapy will be required for the medications listed in the table below provided the following are met:
- The requested product meets the definition of a Medicare outpatient (Part B) drug; AND
- The proposed use of the requested product has been determined to be a medically accepted indication; AND
- The proposed use of the preferred alternative agent has been determined to be a medically accepted indication; AND
- The dose, frequency and duration of use may not exceed the safety and efficacy data supporting the medically accepted indication; AND
- Patient is considered a new start to the non-preferred product (defined as no use in the previous 365 days) AND
- The requested product is necessary for treating the enrollee's condition as the preferred drug(s) has(have) been or is(are) likely to be less effective or have adverse effects; AND
- When there are multiple preferred drugs, unless otherwise specified, only one is required prior to approval of the non-preferred drug.
Requested Product (Non-Preferred) | Preferred Alternative Agent(s) | Special Comments | Effective Date |
Fulphila (Q5108) Fylnetra (Q5130) Rolvedon (J1449) Stimufend (Q5127) Udenyca (Q5111) Ziextenzo (Q5120) |
Nyvepria (Q5122) OR Neulasta (J2506) |
This requirement does not apply to patients using a long active colony-stimulating factor agent for any indication not shared with Nyvepria or Neulasta. | 1/1/2025 |
Herceptin (J9355) Herceptin Hylecta (J9356) Hercessi (Q5146) Herzuma (Q5113) Ogivri (Q5114) Ontruzant (Q5112) |
Kanjinti (Q5117) OR Trazimera (Q5116) |
1/1/2025 | |
Alymsys (Q5126) Avastin (J9035) Avzivi (J9999) Vegzelma (Q5129) |
Mvasi (Q5107) OR Zirabev (Q5118) |
Step Therapy applies for oncology indications only | 1/1/2025 |
Remicade/Infliximab unbranded
(J1745) Renflexis (Q5104) |
Inflectra (Q5103) OR Avsola (Q5121) |
1/1/2025 | |
Durolane (J7318) Euflexxa (J7323) Gel-One (J7326) Gelsyn-3 (J7328) Genvisc 850 (J7320) Hyalgan (J7321) Hymovis (J7322) Monovisc (J7327) Supartz (J7321) Synojoynt (J7331) Triluron (J7332) TriVisc (J7329) Visco-3 (J7321) |
Synvisc/Synvisc-One (J7325) OR Orthovisc (J7324) |
1/1/2025 | |
Alyglo (J1552) Asceniv (J1554) Bivigam (J1556) Flebogamma (J1572) Gammagard S/D (J1566) Gammaplex (J1557) Panzyga (J1459) Yimmugo (J1599) |
Gammagard Liquid (J1569) OR Gammaked (J1561) OR Gamunex-C (J1561) OR Privigen (J1459) OR Octagam (J1568) |
1/1/2025 | |
Cuvitru (J1555) Xembify (J1558) |
Cutaqig (J1551) OR Hizentra (J1559) OR HyQvia (J1575) |
1/1/2025 | |
Injectafer (J1439) Monoferric (J1437) |
Feraheme (Q0138) OR Ferrlecit (J2916) OR Infed (J1750) OR Venofer (J1756) |
1/1/2025 | |
PiaSky (J1307) Soliris (J1300) |
Ultomiris (J1303) | Step Therapy applies for Paroxysmal Nocturnal Hemoglobinuria | 1/1/2025 |
Soliris (J1300) |
Ultomiris (J1303) OR Vyvgart (J9332) OR Vyvgart Hytrulo (J9334) OR Rystiggo (J9333) |
Step Therapy applies for generalized Myasthenia Gravis | 1/1/2025 |
Beovu (J0179) Byooviz (Q5124) Cimerli (Q5128) Eylea (J0178) Eylea HD (J0177) Lucentis (J2778) Pavblu (J3590) Susvimo (J2779) Vabysmo (J2777) |
Bevacizumab (C9257/J9035) | Step Therapy applies for Age Related Macular Degeneration (AMD) | 1/1/2025 |
Riabni (Q5123) Rituxan (J9312) Rituxan Hycela (J9311) |
Ruxience (Q5119) OR Truxima (Q5115) |
1/1/2025 | |
Imuldosa IV (J3590) Otulfi IV (J3590) Pyzchiva (J3590) Wezlana IV (Q5138) |
Stelara IV (J3358) | 1/1/2025 |
References
Centers for Medicare and Medicaid Services, Health Plan Management System (HPMS), MA_Step_Therapy_HPMS_Memo_8_7_18; available at www.cms.gov - last checked Aug. 31, 2018 and found under Medicare > Health Plans > Health Plans - General Information > Downloads.
Published: 2018
Centers for Medicare and Medicaid Services, Medicare Benefit Policy Manual, CMS Pub. 10002, Chapter 15, Sec. 50 (Rev. 241, Feb. 2, 2018); available at www.cms.gov - last checked Aug. 31, 2018 and found under Medicare > Regulations and Guidance > Manuals > InternetOnly Manuals (IOMs).
Published: 2018
Local Coverage Determination (LCD). Centers for Medicare & Medicare Services. www.cms.gov/medicare-coverage-database/search/advanced-search.aspx.
Published: 2024
National Coverage Determination (NCD). Centers for Medicare & Medicare Services. www.cms.gov/medicare-coverage-database/search/advanced-search.aspx
Published: 2024
National Coverage Determination (NCD). Centers for Medicare & Medicare Services. www.cms.gov/medicare-coverage-database/search/advanced-search.aspx
Published: 2024
Revisions
08-07-2024
MA MPC approved policy as written