CurrentCapital BluecrossPolicy N/A

Medicare Part B Step Therapy requirements for outpatient medications

Defines step therapy requirements for Capital Blue Cross Medicare outpatient (Part B) medications, listing non-preferred products, their preferred alternatives, special comments, and effective dates. Affects providers submitting Part B drug requests for Capital Blue Cross members.

Policy Summary

PayerCapital Bluecross

PolicyMedicare Part B Step Therapy requirements for outpatient medications

Policy CodePolicy N/A

Change TypeAdded multiple Step Therapy table entries (effective 1/1/2026)

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization showing trial of a listed preferred alternative (or documented exemption) for Part B drugs when the patient is a new start.

SourceLink

POLICY UPDATE CHANGES

Multiple biologic and injectable products (with HCPCS/Q-codes/J-codes) were added to the Step Therapy table with preferred alternatives and effective date 1/1/2026.

~30listed drug/code entries

1/1/2026common effective date

365new start definition (days)

Coverage Criteria

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General Step Therapy coverage criteria

Covered when ALL of the following are met

Step Therapy applicability: (1) Requested product meets the definition of a Medicare outpatient (Part B) drug; (2) Proposed use of the requested product is a medically accepted indication; (3) Proposed use of the preferred alternative agent is a medically accepted indication; (4) Dose, frequency, and duration do not exceed the safety and efficacy data supporting the medically accepted indication; (5) Patient is a new start (no use in the previous 365 days); (6) Requested product is necessary because the preferred drug(s) have been or are likely to be less effective or cause adverse effects; (7) When multiple preferred drugs exist, unless otherwise specified, only one is required prior to approval of the non-preferred drug.

General gatekeeping criteria for prior authorization and coverage

Coding / Step Therapy Entries

Step Therapy entries (group 1)mixed

Q5126	Alymsys
19035	Avastin
Q5129	Vegzelma
J9999	Avzivi
Q5107	Mvasi (preferred alternative)
Q5118	Zirabev (preferred alternative)
J1442	Neupogen
Q5125	Releuko
05148	Nypozi
J1447	Granix (preferred alternative)

1–10 of 20

1/2

Step Therapy entries (group 2)mixed

Q5121	Avsola
Q5104	Renflexis
J9036	Belrapzo
J9034	Bendeka
Q5103	Inflectra
J1745	Infliximab / Remicade
Q0138	Feraheme
J1439	Injectafer
J1437	Monoferric
J2916	Ferrlecit (preferred alternative)

1–10 of 12

1/2

Step Therapy entries (group 3)mixed

J0641	Fusilev
J0642	Khapzory
J0640	Leucovorin (preferred alternative)
Q5123	Riabni
J9312	Rituxan
J9311	Rituxan Hycela
Q5119	Ruxience (preferred alternative)
Q5115	Truxima (preferred alternative)
J1299	Soliris
Q5152	Bkemv

1–10 of 11

1/2

Step Therapy entries (group 4)mixed

Q5146	Hercessi
J9355	Herceptin
19356	Herceptin Hylecta
Q5113	Herzuma
Q5114	Ogivri
Q5117	Kanjinti (preferred alternative)
Q5116	Trazimera (preferred alternative)
17326	Gel-One
J7328	Gelsyn-3
J7320	Genvisc 850

1–10 of 19

1/2

Ophthalmic and other entriesmixed

J0178	Eylea
12778	Lucentis
J0179	Beovu
Q5124	Byooviz
J2779	Susvimo
02777	Vabysmo
Q5128	Cimerli
J0177	Eylea HD
J3590	Yesafili
Q5150	Ahzantive

1–10 of 15

1/2

inv-09: New start definition — No use in the previous 365 days

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

Applies toInitiation of a non-preferred Medicare outpatient (Part B) drug when Step Therapy prerequisites are assessed.

Documentation neededProvider must attest to and document that the patient has not used the non-preferred product in the prior 365 days.

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization Required — Prior authorization is required per the Step Therapy table for Medicare Part B (outpatient) medications. Providers must document that the requested product meets the definition of a Medicare outpatient (Part B) drug and that the proposed use is a medically accepted indication. Prior authorization will only be approved when Step Therapy requirements (trial of preferred alternative agent(s)) are met unless an exception is documented and supported.

Providers must confirm patient is a new start to the non‑preferred product (no use in the previous 365 days).
Dose, frequency, and duration must not exceed evidence-based safety and efficacy for the indicated use.
When multiple preferred drugs are listed, trial of only one listed preferred agent is required unless otherwise specified.
Special comments in the Step Therapy table (e.g., non‑oncology Avastin indications) may waive prerequisite agent requirements per the table.

Step Therapy

Step Therapy Requirement

Step Therapy Requirement — Prior to approval of a non‑preferred product, the provider must document a trial and failure, contraindication, or intolerance to the specified preferred alternative agent(s) listed in the Step Therapy table. The patient must meet the definition of a "new start" for the non‑preferred product.

Trial requirement applies only when the requested product is a Medicare Part B outpatient drug and the proposed use is a medically accepted indication.
Effective dates and specific preferred alternatives are listed in the Step Therapy table; follow the table entries for agent substitutions and effective dates (e.g., many entries effective 1/1/2026).

Documentation Required

Documentation Required — Providers must include documentation verifying Medicare Part B outpatient drug status, the medically accepted indication for the requested product, and documentation of prior trials (dates, agents, clinical response, and reason for discontinuation) of preferred alternatives per policy.

If claiming exception due to contraindication or intolerance, include clinical rationale and supporting records.
Include dosing, frequency, and duration information to demonstrate whether prior use falls within the 365‑day new‑start window.

Denial Risk

Triggers for Denial

Triggers for Denial — Requests may be denied when Step Therapy requirements are not met or when documentation is insufficient to support an exception or medical necessity for the non‑preferred product.

Requested product does not qualify as a Medicare Part B outpatient drug for the proposed use.
No documentation of trial (and failure/intolerance/contraindication) to the required preferred alternative(s) as listed in the Step Therapy table.
Patient does not meet the "new start" definition (evidence of use of the non‑preferred product within the previous 365 days).
Dose, frequency, or duration exceeds the safety/efficacy data supporting the medically accepted indication.
Clinical rationale provided for exception is insufficient or unsupported by medical records.

Definitions

inv-15: No use in the previous 365 days — New start

Policy statementA patient is a 'new start' for Step Therapy if there was no use of the requested non-preferred product in the previous 365 days.

Timing threshold365 days (look-back period).

Effect on prior authorizationStep Therapy prerequisites are required for members who meet the 'new start' definition unless a table entry specifically exempts the prerequisite.

Relation to continuation therapyIf the patient used the non-preferred product within 365 days, Step Therapy initiation requirement does not apply (may affect denial risk).

inv-16: Definition — A drug meeting the definition of a Medicare outpatient (Part B) drug as required for Step Therapy applicability

DefinitionA drug meeting the definition of a Medicare outpatient (Part B) drug as required for Step Therapy applicability.

RequirementThe requested product must be a Medicare Part B outpatient drug for Step Therapy rules to apply.

DocumentationProvider must document that the requested product meets the Medicare outpatient (Part B) drug definition when submitting for prior authorization.

Initial Therapy Criteria

Initial therapy requirements

Initial therapy for listed non-preferred products

Initial Step Therapy trial: Patient must be a new start (no use in the prior 365 days) and must have trialed an indicated preferred alternative agent for the listed non-preferred product unless the product-specific entry includes a special comment exempting the prerequisite (for example, non-oncology Avastin indications).No use in the previous 365 days

Applies at initiation of non-preferred product; when multiple preferred agents are listed, trial of one is sufficient unless otherwise specified.

Step Therapy requirement
Try at least one specified preferred alternative agent prior to approval of the non‑preferred product, unless a special comment for that product indicates an exemption (for example, non‑oncology indications for Avastin do not require prerequisite agents).

Biosimilar Preferred Alternatives

Billing Rule

Avastin group — try Mvasi or Zirabev first

For the Avastin group (Alymsys/Avastin/Vegzelma/Avzivi), preferred alternatives that must be tried prior to approval are Mvasi (Q5107) or Zirabev (Q5118); note that non-oncology indications for Avastin are exempt from prerequisite agents.

Alymsys (Q5126), Avastin (19035), Vegzelma (Q5129), Avzivi (J9999) — preferred: Mvasi (Q5107) or Zirabev (Q5118)
Special comment: Non-oncology indications for Avastin will not require prerequisite agents

Billing Rule

Rituximab group — try Ruxience or Truxima first

For the Rituximab group (Riabni/Rituxan/Rituxan Hycela), preferred alternatives that must be tried prior to approval are Ruxience (Q5119) or Truxima (Q5115).

Riabni (Q5123), Rituxan (J9312), Rituxan Hycela (J9311) — preferred: Ruxience (Q5119) or Truxima (Q5115)

OpenPayer