CurrentCapital BluecrossPolicy N/A

Medicare Part B Step Therapy for outpatient medications

Defines step therapy requirements for Medicare outpatient (Part B) drugs, specifying preferred alternatives and prerequisite agents for non-preferred drugs; affects providers prescribing these Part B medications for enrollees.

Policy Summary

PayerCapital Bluecross

PolicyMedicare Part B Step Therapy for outpatient medications

Policy CodePolicy N/A

Change TypeMultiple product groups updated with new preferred agents and effective dates (1/1/2026 and 5/1/2026).

Effective Dateas written

Next Review DateN/A

Key ActionObtain and document prior authorization showing the patient is a new start and trial/failure of the listed preferred alternative agent(s).

SourceLink

POLICY UPDATE CHANGES

Multiple biologic and biosimilar products listed with preferred alternative agents and effective dates of 1/1/2026 for many entries.

Hyaluronic acid derivatives preferred products updated to Euflexxa (J7323) and Synvisc/Synvisc One (J7325) with effective date 5/1/2026.

Jobevne (Q5160) requires trial/failure of Mvasi (Q5107) or Zirabev (Q5118) effective 5/1/2026.

Ryzneuta (J9361) requires trial/failure of Neulasta (J2506) or Udenyca (Q5111) effective 5/1/2026.

multipleproducts with preferred alternative(s) noted

1/1/2026effective date shown for many product groups

5/1/2026

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Coverage and Step Therapy Criteria

General Step Therapy Criteria

Covered when ALL of the following are met

General requirements: The requested product is a Medicare outpatient (Part B) drug; the proposed use of the requested product is a medically accepted indication; the proposed use of the preferred alternative agent is a medically accepted indication; dose, frequency, and duration do not exceed evidence-supported safety/efficacy; the patient is a new start to the non-preferred product (no use in the previous 365 days); and the requested product is necessary because the preferred drug(s) have been or are likely to be less effective or have adverse effects.

When multiple preferred drugs exist, unless specified, only one is required prior to approval.

Product-specific Criteria

Product-specific prerequisites or preferred alternatives

Avastin biosimilars: For Alymsys (Q5126), Avastin (J9035), Vegzelma (Q5129), and Avzivi (J9999) the preferred alternatives listed include Mvasi (Q5107) and Zirabev (Q5118).

Non-oncology indications for Avastin will not require prerequisite agents; effective date = 1/1/2026.

Filgrastim (filgrastim) group: For Neupogen (J1442), Releuko (Q5125), and Nypozi (Q5148) preferred alternatives include Granix (J1447), Nivestym (Q5110), and Zarxio (Q5101).

Effective date = 1/1/2026.

Pegfilgrastim (pegfilgrastim) group: For Fulphila (Q5108), Fylnetra (Q5130), Nyvepria (Q5122), and Rolvedon (J1449) preferred alternatives include Neulasta (J2506) and Udenyca (Q5111).

Effective date = 1/1/2026.

Hyaluronic acid derivatives: Multiple hyaluronic acid derivative products (e.g., Gel-One, Gelsyn-3, Genvisc 850, Hyalgan, Hymovis, Monovisc, Orthovisc, Supartx FX, Synojoynt, Triluron) list Euflexxa (J7323) AND Synvisc/Synvisc One (J7325) as the preferred products.

Preferred products updated; effective date = 5/1/2026.

Ophthalmic anti-VEGF group: For ophthalmic anti-VEGF products (e.g., Eylea, Lucentis, Beovu, Byooviz, Susvimo, Vabysmo, Cimerli, Eylea HD, Visco-3), Avastin ophthalmic use only (C9257) is listed as a required prior agent for applicable entries.

Effective date = 1/1/2026 for listed entries.

For the Avastin product group (Alymsys Q5126; Avastin J9035; Vegzelma Q5129; Avzivi J9999), the policy lists Mvasi (Q5107) and Zirabev (Q5118) as the preferred alternative agents. However, the policy explicitly notes that non-oncology indications for Avastin will not require prerequisite agents, meaning step therapy prerequisites do not apply when Avastin is used for non-oncology (e.g., certain ophthalmic) indications.

Coverage under this step therapy policy is conditional: a requested Medicare outpatient (Part B) drug is covered only when all specified step criteria are met. The general requirements include that the requested product and any preferred alternative(s) are being used for a medically accepted indication, dosing/frequency/duration are within evidence-supported limits, and the patient is a new start to the non-preferred product (no use in the previous 365 days). Product-specific table entries list required prerequisite agent(s) and effective dates; unless a product-specific exception is stated, trial of the listed preferred agent(s) is required prior to coverage of the non-preferred product.

HCPCS / Drug Codes and New-Start Definition

Step Therapy Part B drug codes listedmixed

Q5126	Alymsys
J9035	Avastin
Q5129	Vegzelma
J9999	Avzivi (placeholder J9999 in table)
Q5107	Mvasi
Q5118	Zirabev
J1442	Neupogen
Q5125	Releuko
Q5148	Nypozi
J1447	Granix

1–10 of 80

1/8

inv-06: New start — no use in previous 365 days

DefinitionNew start = no use of the requested non-preferred product in the previous 365 days.

Applies toPatient must be a new start to the non-preferred product to meet step therapy criteria.

Documentation implicationProvider must document absence of use of the non-preferred product in the last 365 days to support authorization.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization and step therapy are required for the Medicare Part B outpatient drugs listed in the policy table. Providers must document that the requested product meets the Medicare Part B outpatient drug definition and that the proposed use is a medically accepted indication. The patient must be a new start to the non-preferred product (no use in the previous 365 days). When multiple preferred drugs exist, unless otherwise specified, only one preferred agent is required prior to approval of the non-preferred drug.

Prior authorization/step therapy applies only when: the drug is a Medicare Part B outpatient (Part B) medication; the requested and preferred agent uses are medically accepted indications; dosing does not exceed evidence-supported safety/efficacy; patient is a new start (no use in prior 365 days).
If multiple preferred alternatives are listed, a trial of a single preferred agent is sufficient unless the table specifies otherwise.

Step Therapy

Step Therapy Rules

Step therapy requires documentation of a trial and lack of adequate response or intolerance to the specified preferred alternative agent(s) before the non-preferred agent will be approved. The required preferred agent(s) and any special comments or exemptions (for example: non-oncology indications for bevacizumab/Avastin) are listed in the policy table. Effective dates for each requirement are shown in the table; providers must reference the table entry effective date when submitting requests.

Initial Therapy Examples and Requirements

Initial therapy examples

Initial therapy requirements (examples)

Jobevne requirement: Jobevne (Q5160) requires trial and failure (T/F) of Mvasi (Q5107) or Zirabev (Q5118).

Effective date = 5/1/2026.

Ryzneuta requirement: Ryzneuta (J9361) requires trial and failure (T/F) of Neulasta (J2506) or Udenyca (Q5111).

Effective date = 5/1/2026.

Requirement	Details
Step therapy requirement
Trial of the specified preferred agent(s) is required prior to approval of the non-preferred Part B drug listed in the policy table.
New start definition
Patient must be a new start to the requested non-preferred product, defined as no use of the requested product in the previous 365 days.
Preferred alternatives — example: Avastin group
For Alymsys (Q5126), Avastin (J9035), Vegzelma (Q5129), Avzivi (J9999) the preferred alternatives are Mvasi (Q5107) or Zirabev (Q5118). Non‑oncology indications for Avastin do not require prerequisite agents (effective 1/1/2026).
Preferred alternatives — example: pegfilgrastim/filgrastim groups
Examples include: Neupogen/Releuko/Nypozi preferred alternatives Granix (J1447), Nivestym (Q5110), Zarxio (Q5101) (effective 1/1/2026); Fulphila/Fylnetra/Nyvepria/Rolvedon preferred alternatives Neulasta (J2506) or Udenyca (Q5111) (effective 1/1/2026).
Exceptions and special comments
When product-specific notes apply (for example ophthalmic Avastin C9257 or stated non-oncology exemptions), those exceptions supersede the prerequisite requirement for those uses as noted in the table entries.

Biosimilar and Preferred Agent Notes

Billing Rule

Trial of Mvasi or Zirabev required for some Avastin-group products

For Avastin (J9035) group products listed in the table, trial of Mvasi (Q5107) or Zirabev (Q5118) are listed as preferred alternatives and must be documented prior to coverage of some non-preferred Avastin-group products.

Alymsys (Q5126), Avastin (J9035), Vegzelma (Q5129), Avzivi (J9999) list Mvasi (Q5107) and Zirabev (Q5118) as preferred alternatives.
Effective date for these entries shown as 1/1/2026 in the table; Jobevne (Q5160) also requires T/F of Mvasi or Zirabev effective 5/1/2026 as noted in references.

Note

Avastin biosimilars — Mvasi and Zirabev listed as preferred

Mvasi (Q5107) and Zirabev (Q5118) are listed as preferred alternatives for Avastin biosimilars in the table.

Applicable Settings

Note

Policy applies to Medicare Part B outpatient (infusion center) settings

This policy applies to Medicare outpatient (Part B) medications administered in applicable Part B settings (e.g., infusion center); confirm the administration setting qualifies as Medicare Part B outpatient when submitting authorization requests.

Policy applies to Medicare outpatient (Part B) medications administered in applicable Part B settings.
Ensure the claim/authorization indicates the medication is being provided in a Part B outpatient setting.

Key Definitions

inv-12: New start defined as no use in the previous 365 days

Definition (formal)New start defined as no use in the previous 365 days.

ScopeThis definition applies to determination of whether step therapy prerequisites are required for the requested Part B drug.

Timeframe for reviewReview medication administration/claims for the prior 365 days to determine new start status.

inv-13: Proposed use must be a medically accepted indication for both requested and preferred products

RequirementThe proposed use must be a medically accepted indication for both the requested product and the preferred alternative agent.

Evidence standardDose, frequency, and duration must not exceed the safety and efficacy data supporting the medically accepted indication.

Background and Rationale

Step therapy is a utilization management approach applied to Medicare outpatient (Part B) medications in applicable Part B settings that requires a documented trial of preferred agent(s) before a non-preferred Part B drug will be approved. The policy requires providers to show that the patient is a new start (no use in the prior 365 days) and to document trial/failure or contraindication to the preferred alternative(s) listed for the non-preferred product; updates to preferred agent lists and effective dates are noted in the table and references (for example, hyaluronic acid derivative and certain biosimilar updates effective 1/1/2026 or 5/1/2026).