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: 

  1. The requested product meets the definition of a Medicare outpatient (Part B) drug; AND 
  2. The proposed use of the requested product has been determined to be a medically accepted indication; AND 
  3. The proposed use of the preferred alternative agent has been determined to be a medically accepted indication; AND 
  4. The dose, frequency and duration of use may not exceed the safety and efficacy data supporting the medically accepted indication; AND 
  5. Patient is considered a new start to the non-preferred product (defined as no use in the previous 365 days) AND 
  6. 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 
  7. 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