Medicare Part B Step Therapy for outpatient drugs
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Defines step therapy requirements for Medicare outpatient (Part B) medications administered to Capital Blue Cross enrollees, specifying required prior/ preferred agents and conditions for approval. Affects providers requesting coverage for listed Part B drugs for Medicare members.
Multiple drug entries and preferred alternative agents were added with an effective date of 1/1/2026.
Hyaluronic acid derivatives preferred products were updated to Euflexxa (J7323) and Synvisc/Synvisc One (J7325) with effective date 5/1/2026.
Additional step therapy updates (Jobevne, Ryzneuta, Nucala preferences) scheduled effective 5/1/2026.
Step Therapy Coverage Criteria
General step therapy coverage criteria
Covered when ALL of the following are met:
Defined as no use of the non-preferred product in the previous 365 days
When multiple preferred drugs exist, only one is required unless otherwise specified
Non-oncology indications for Avastin (J9035) are exempt from the step therapy prerequisite agent requirement. For Avastin uses outside of oncology (as noted in the policy table), providers do not need to document prior trial and failure or intolerance to the listed preferred alternatives before requesting coverage.
Use of a non-preferred product without meeting the step therapy requirements (for example, when a required trial of the specified preferred alternative has not been completed) does not satisfy the coverage criteria. The policy requires that the requested product meet the Part B drug definition, the proposed use be a medically accepted indication, dose/frequency/duration be consistent with supporting data, the patient be a new start to the non-preferred product (no use in the prior 365 days), and documentation that the preferred agent(s) were ineffective or not tolerated before the non-preferred product will be approved.
Coding and HCPCS / J-code Groups
Prior Authorization, Documentation, and Denials
Prior authorization: document trial and failure/intolerance to preferred agent(s)
Prior authorization is required per the step therapy table. The provider must document a trial and failure or intolerance to the required preferred agent(s) listed for the requested non-preferred Part B drug before approval of the non-preferred product, unless special comments or exceptions apply.
- PA required for drugs listed in the step therapy table (see codes in brief).
- Document trial and failure or intolerance to the specified preferred alternative(s).
Step therapy rule: trial preferred agent(s); patient must be a new start
Step therapy requires a trial of the specified preferred alternative agent(s) for the listed Medicare Part B drugs; the patient must be a new start to the non-preferred product, defined as no use in the prior 365 days. When multiple preferred drugs exist, only one is required unless otherwise specified.
- New start = no use of the non-preferred product in the previous 365 days.
- If multiple preferred alternatives are listed, only one needs to be tried unless the entry states otherwise.
Required clinical documentation: Part B status, accepted indication, and trial rationale
Include clinical documentation that the requested product meets the Medicare outpatient (Part B) drug definition, that the proposed use is a medically accepted indication, and clinical rationale showing preferred alternative(s) were tried and were less effective or caused adverse effects; also document dose, frequency, and duration consistent with supporting safety/efficacy data.
- Evidence the drug is a Part B outpatient medication.
- Clinical indication is medically accepted for the requested and preferred agent(s).
- Notes describing trials of preferred agents and reasons for failure/intolerance, plus dose/frequency/duration.
Denial triggers: Part B status, indication, missing trials, dosing, prior use
Requests may be denied if the requested product does not meet the Part B drug definition, the proposed use is not a medically accepted indication, the preferred alternative has not been tried (unless an exception applies), dose/frequency/duration exceed the supporting safety/efficacy data, or the member used the non‑preferred product within the prior 365 days.
- Denial triggers include failure to establish Part B status or medically accepted indication.
- Denial if required preferred agent(s) were not tried and documented, or if dosing exceeds supported parameters.
- Denial if member used the non-preferred product within the previous 365 days (not a new start).
Policy Background
Step therapy is applied to Medicare Part B outpatient medications to encourage use of preferred alternatives that have established efficacy and safety before covering non-preferred products. Approval under step therapy requires that the requested product qualify as a Medicare outpatient (Part B) drug, that the proposed use is a medically accepted indication for both the requested and preferred agents, and that the patient be a new start to the non-preferred product (defined as no use in the previous 365 days). When multiple preferred drugs are listed, only one must be tried unless the policy specifies otherwise.
Definitions
Initial Therapy Requirements
Initial therapy requirements
Initial authorization requires trial of the listed preferred alternative agent(s) for the specific non-preferred product unless an exception applies.
When multiple preferred agents exist, only one is required unless otherwise specified
Continuation Therapy
Continuation therapy
Continuation of therapy generally requires meeting initial step criteria and documentation of benefit.
Document dose, frequency, and duration consistent with safety/efficacy data
Step Therapy Table and Product Lists
| Non‑preferred Part B drug (examples) | Required preferred alternative(s) (trial and failure/intolerance required) | New‑start lookback / notes |
|---|---|---|
| Alymsys (Q5126) / Avastin (J9035) / Vegzelma (Q5129) / Avzivi (J9999) | Mvasi (Q5107) or Zirabev (Q5118) | Patient must be a new start to the non‑preferred product (no use in prior 365 days). Non‑oncology Avastin indications are exempt from prerequisite agents. |
| Neupogen (J1442) / Releuko (Q5125) / Nypozi (Q5148) | Granix (J1447) or Nivestym (Q5110) or Zarxio (Q5101) | Patient must be a new start to the non‑preferred product (no use in prior 365 days). |
| Fulphila (Q5108) / Fylnetra (Q5130) / Nyvepria (Q5122) / Rolvedon (J1449) | Neulasta (J2506) or Udenyca (Q5111) | Patient must be a new start to the non‑preferred product (no use in prior 365 days). |
| Stimufend (Q5127) / Ziextenzo (Q5120) / Ryzneuta (J9361) | When specified: Neulasta (J2506) or Udenyca (Q5111) for Ryzneuta per updates; otherwise preferred alternative(s) listed in table. | Patient must be a new start to the non‑preferred product (no use in prior 365 days). Effective dates: many entries 1/1/2026; some updates 5/1/2026. |
| Treanda (J9033) / Vivimusta (J9056) | Belrapzo (J9036) or Bendeka (J9034) | Patient must be a new start to the non‑preferred product (no use in prior 365 days). |
| Avsola (Q5121) / Renflexis (Q5104) | Inflectra (Q5103) or Infliximab unbranded (J1745) | Patient must be a new start to the non‑preferred product (no use in prior 365 days). |
| Feraheme (Q0138) / Injectafer (J1439) / Monoferric (J1437) | Ferrlecit (J2916) or InFed (J1750) or Venofer (J1756) | Patient must be a new start to the non‑preferred product (no use in prior 365 days). |
| Fusilev (J0641) / Khapzory (J0642) | Leucovorin (J0640) | Patient must be a new start to the non‑preferred product (no use in prior 365 days). |
| Riabni (Q5123) / Rituxan (J9312) | Ruxience (Q5119) or Truxima (Q5115) | Patient must be a new start to the non‑preferred product (no use in prior 365 days). |
| Complement inhibitors: Soliris (J1299) / Bkemv (Q5152) / Epysqli (Q5151) | Ultomiris (J1303) | Patient must be a new start to the non‑preferred product (no use in prior 365 days). |
| Trastuzumab group: Hercessi (Q5146) / Herceptin (J9355) / Herceptin Hylecta (J9356) / Herzuma (Q5113) / Ogivri (Q5114) | Kanjinti (Q5117) or Trazimera (Q5116) | Patient must be a new start to the non‑preferred product (no use in prior 365 days). |
| Hyaluronic acid derivatives (e.g., Gel‑One J7326, Gelsyn‑3 J7328, Genvisc 850 J7320, Hyalgan J7328, Hymovis J7322, Monovisc J7327, Orthovisc J7324, Supartx FX J7321, Synojoynt J7331, Triluron J7332) | Preferred products updated to Euflexxa (J7323) AND Synvisc/Synvisc One (J7325) | Patient must be a new start to the non‑preferred product (no use in prior 365 days). Preferred product update effective date noted (see references). |
| Ophthalmic biologics: Visco‑3 (J7321) / Eylea (J0178) / Lucentis (J2778) / Beovu (J0179) / Byooviz (Q5124) / Susvimo (J2779) / Vabysmo (J2777) / Cimerli (Q5128) / Eylea HD (J0177) | Avastin — ophthalmic use only (C9257) is listed as a preferred alternative where indicated | Patient must be a new start to the non‑preferred product (no use in prior 365 days). |
| Asthma/respiratory biologics: Ahzantive (Q5150) / Pavblu (Q5147) / Enzeevu (Q5149) / Cinqair (J2786) | Cinqair preferred alternatives include Fasenra (J0517) or Nucala (J2182) | Patient must be a new start to the non‑preferred product (no use in prior 365 days). |
Biosimilar Specific Notes
Avastin (J9035): trial preferred biosimilars first; non‑oncology uses exempt
For Avastin (J9035) and listed related products, providers must first use the preferred alternatives Mvasi (Q5107) or Zirabev (Q5118) per the step therapy table; note that non-oncology indications for Avastin are exempt from prerequisite agents.
Avsola (Q5121) / Renflexis (Q5104): trial preferred infliximab products first
For Avsola (Q5121) and Renflexis (Q5104), providers must document trial of the preferred infliximab products Inflectra (Q5103) or the infliximab unbranded/Remicade (J1745) before the non-preferred product is approved.
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