CurrentFlorida BluePolicy N/A

Medicare Advantage Part B Step Therapy updates

Defines updates to Florida Blue Medicare Advantage Part B Step Therapy categories, preferred and non-preferred Part B drugs, and related coding for prescribing and prior authorization effective for affected BlueMedicare plans.

Policy Summary

PayerFlorida Blue

PolicyMedicare Advantage Part B Step Therapy updates

Policy CodePolicy N/A

Change TypeNew category + revisions to existing categories

Effective DateMay 1, 2025

Next Review DateN/A

Key ActionPrescribe preferred alternatives or meet Step Therapy and medical necessity requirements before using non-preferred Part B medications; prior authorization may apply.

SourceLink

POLICY UPDATE CHANGES

A new category and revisions to four categories are included in the Part B Step Therapy program effective May 1, 2025.

Saphnelo (and J0491) listed as non-preferred for Systemic Lupus Erythematosus agents; Benlysta (IV/SC) listed as preferred.

Updates to Cardiovascular/Cholesterol Lowering Agents category with preferred and non-preferred products and related J-codes.

Complement inhibitors category updated: multiple agents listed as preferred or non-preferred by indication (gMG, PNH, aHUS, NMOSD) and orphan-indication exceptions for Soliris noted.

Ophthalmic agents category updated with bevacizumab coding and lists of preferred/non-preferred ophthalmic products and viscosupplements with HCPCS/J-codes.

May 1, 2025effective date for updates

1new category added

>=4

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Coverage and Step Therapy Criteria

General Step Therapy Coverage Criteria

Covered when drug selection and Step Therapy requirements are met according to category-specific preferences and indications.

Step Therapy Requirement: Provider must meet Step Therapy requirements and medical necessity definitions for non-preferred Part B medications; preferred alternatives are encouraged and may require prior authorization.

Based on policy categories and codes (SLE agents, cardiovascular/cholesterol lowering agents, complement inhibitors, ophthalmic agents, viscosupplements).

Per CMS guidance, Step Therapy does not apply for other orphan indications for Soliris. For these orphan uses—listed in the source document as dermatomyositis, shiga-toxin producing E. coli HUS, idiopathic membranous glomerular nephropathy, and prevention of delayed graft rejection in renal transplant—coverage is determined solely by medical necessity criteria rather than Step Therapy requirements.

Coding and HCPCS/J-Code Designations

Systemic Lupus Erythematosus (SLE) AgentsHCPCS

J0490	Benlysta (IV) / billing code listed as preferred
C9399	Benlysta (SC) / billing code listed as preferred
J3590	Benlysta (SC) / alternative billing
J0491	Saphnelo / non-preferred

Cardiovascular/Cholesterol Lowering AgentsHCPCS

J3590	Cardiovascular agents coding
C9399	Cardiovascular agents coding
J1306	Leqvio or related product code
J1305	Evkeeza or related product code

Complement InhibitorsHCPCS

J1303	Ultomiris / preferred for several complement inhibitor indications
J9332	Vyvgart / listed among preferred product codes
J9334	Vyvgart Hytrulo related code
J9333	Vyvgart related code
J1300	Soliris / listed as non-preferred product code
J1299	Soliris / alternate non-preferred code
J1307	Empaveli / non-preferred code listed
Q5152	Complement inhibitor code
Q5151	Complement inhibitor code
J3490	Empaveli / alternative billing

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1/2

Ophthalmic AgentsHCPCS

J3490	Bevacizumab (compounded/billed) codes
C9257	Bevacizumab HCPCS
J0179	Ophthalmic agent code
Q5124	Ophthalmic agent code
Q5128	Ophthalmic agent code
J0178	Ophthalmic agent code
J0177	Ophthalmic agent code
J2778	Ophthalmic agent code
J2503	Ophthalmic agent code
J2779	Ophthalmic agent code

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ViscosupplementsHCPCS

J7325	Synvisc/Synvisc One viscosupplement
J7324	Orthovisc viscosupplement
J7318	Viscosupplement code
J7323	Viscosupplement code
J7326	Viscosupplement code
J7328	Viscosupplement code
J7320	Viscosupplement code
J7321	Viscosupplement code (multiple appearances)
J7322	Viscosupplement code
J7327	Viscosupplement code

1–10 of 13

1/2

Orphan indication exception applicability — Soliris

ApplicabilityStep Therapy does NOT apply to Soliris for specified orphan indications; only medical necessity criteria apply per CMS guidance.

Named orphan indicationsDermatomyositis; shiga-toxin producing E. coli HUS; idiopathic membranous glomerular nephropathy; prevention of delayed graft rejection in renal transplant.

Impacted product codesSoliris listed with HCPCS codes J1300 and J1299 as non-preferred but exempt from Step Therapy for the orphan indications noted.

ScopeApplies within the Complement Inhibitors category where Soliris would otherwise be non-preferred; exemption follows CMS guidance.

Provider Requirements, Prior Authorization & Billing Guidance

Prior Authorization

Part B medications requiring prior authorization or step therapy

Step Therapy is required for specified non-preferred Medicare Part B medications. Prescribers should consider using preferred alternatives when clinically appropriate; prior authorization may still be required for preferred products in some categories.

Affected categories include: Cardiovascular/Cholesterol Lowering Agents; Complement Inhibitors (e.g., Soliris, Ultomiris, Empaveli, Enspryng, Uplizna, Vyvgart, Vyvgart Hytrulo, Rystiggo); Ophthalmic Agents (e.g., Bevacizumab vs other intravitreal agents); Viscosupplements.

Step Therapy

Step Therapy requirement overview

Step Therapy requires trial of one or more preferred Part B products before coverage of specified non-preferred agents. The number and identity of required step agents vary by drug category and indication; some categories list HCPCS/J‑codes for preferred versus non-preferred products.

Cardiovascular/Cholesterol Lowering Agents: preferred biologics (e.g., Repatha, Praluent) vs non-preferred listed J‑codes (e.g., J3590, C9399, J1306, J1305).

Policy Background

This document summarizes the Part B Step Therapy program for BlueMedicare Medicare Advantage plans, listing affected Part B drug categories and identifying preferred and non-preferred products by category and indication to guide prescribing and prior authorization decisions.

Definitions and Exceptions

Orphan-indication exception — definition

DefinitionAn orphan-indication exception means Step Therapy requirements do not apply for Soliris when used to treat specified orphan indications; coverage is evaluated using standard medical necessity criteria per CMS guidance.

Examples of orphan indicationsDermatomyositis; shiga-toxin producing E. coli HUS; idiopathic membranous glomerular nephropathy; prevention of delayed graft rejection in renal transplant.

Policy effectAlthough Soliris is listed as non-preferred (J1300, J1299) in the Complement Inhibitors category, the orphan-indication exception overrides Step Therapy for the listed indications.

Initial Therapy Guidance

Initial therapy guidance

Preferred alternatives recommended before non-preferred agents.

Initial Therapy: Consider prescribing preferred alternatives listed for each category prior to non-preferred agents; Step Therapy is required for specified non-preferred Part B drugs and medical necessity must be documented.

Prior authorization may apply for preferred alternatives or non-preferred products.

Step Therapy Table and Category Exceptions

Drug category / indication	Preferred product(s) / codes	Non‑preferred product(s) / codes	Step therapy requirement
Systemic Lupus Erythematosus (SLE) agents	Benlysta (IV) - J0490; Benlysta (SC) - C9399; alternative billing J3590	Saphnelo - J0491 (listed as non‑preferred)	Step Therapy required for non‑preferred SLE agents; preferred alternatives are encouraged (prior authorization may apply).
Cardiovascular / Cholesterol Lowering Agents	Preferred products: Repatha, Praluent; codes include J3590, C9399	Non‑preferred products: Leqvio, Evkeeza; codes include J1306, J1305	Step Therapy required for non‑preferred cardiovascular agents; consider preferred alternatives first (prior authorization may apply).
Complement inhibitors — Myasthenia gravis (gMG)	Preferred products/codes: Ultomiris - J1303; Vyvgart - J9332/J9334/J9333	Non‑preferred products/codes: Soliris - J1300/J1299 (and PiaSky, Bkemv, Epysqli)	Step Therapy required for non‑preferred products for gMG; providers should use preferred agents when appropriate (prior authorization may apply).
Complement inhibitors — Paroxysmal nocturnal hemoglobinuria (PNH)	Preferred products/codes: Empaveli - C9399/J3490; Ultomiris - J1303	Non‑preferred products/codes: Soliris - J1300/J1299 (and PiaSky, Bkemv, Epysqli) / J1307, Q5152, Q5151	Step Therapy required for non‑preferred products for PNH; exception: step therapy does not apply to certain Soliris orphan indications (see policy).
Complement inhibitors — Atypical HUS (aHUS)	Preferred product/code: Ultomiris - J1303	Non‑preferred products/codes: Soliris - J1300/J1299 (and PiaSky, Bkemv, Epysqli) / J1307, Q5152, Q5151	Step Therapy required for non‑preferred products for aHUS; note orphan‑indication exceptions for Soliris per CMS guidance.
Complement inhibitors — Neuromyelitis optica spectrum disorder (NMOSD)	Preferred products/codes: Enspryng, Uplizna, Ultomiris - C9399, J1823, J1303	Non‑preferred products/codes: Soliris - J1300/J1299 (and PiaSky, Bkemv, Epysqli) / J1307, Q5152, Q5151	Step Therapy required for non‑preferred products for NMOSD; Soliris orphan‑indication exceptions apply where specified.
Ophthalmic agents (bevacizumab vs retinal biologics)	Preferred product(s) / bevacizumab coding: Bevacizumab - J3490, C9257	Non‑preferred products: Beovu, Byooviz, Cimerli, Eylea, Eylea HD, Lucentis, Macugen, Susvimo, Vabysmo, Visudyne, Pavblu, Enzeevu, Ahzantive; associated codes listed in policy (J0179, Q5124, Q5128, J0178, J0177, J2778, J2503, J2779, J2777, J3396, Q5147, Q5149, Q5150)	Step Therapy required for non‑preferred ophthalmic biologics; providers are encouraged to consider bevacizumab alternatives first (prior authorization may apply).
Viscosupplements	Preferred products: Synvisc / Synvisc One, Orthovisc; example codes J7325, J7324	Non‑preferred products: Durolane, Euflexxa, Gel‑One, Gelsyn‑3, Genvisc‑850, Hyalgan, Hymovis, Monovisc, Supartz, Supartz FX, Synojoynt, Triluron, Trivisc, Visco‑3; codes include J7318, J7323, J7326, J7328, J7320, J7321, J7322, J7327, J7331, J7332, J7329	Step Therapy applies according to category listing; viscosupplement coding identifies preferred vs non‑preferred products per policy.