ModifiedFlorida BluePolicy N/A

Updated Categories for Medicare Advantage Part B Step Therapy

Updates to Florida Blue Medicare Part B Step Therapy program effective 2025-07-15: one category removed and three categories added/updated (Drug Alternatives, Cancer and Supportive Therapy, Complement Inhibitors, Ophthalmic Agents). Identifies preferred and non-preferred products and associated HCPCS/J-codes; medical necessity reviews still apply.

Policy Summary

PayerFlorida Blue

PolicyUpdated Categories for Medicare Advantage Part B Step Therapy

Policy CodePolicy N/A

Change TypeCategories added/updated

Effective DateJul 15, 2025

Next Review Date

Key ActionPrior authorization may be required for preferred alternatives or non-preferred Part B drugs per Step Therapy program; medical necessity reviews continue to apply for each drug.

SourceLink

POLICY UPDATE CHANGES

One category removed and three categories added/updated to the Part B Step Therapy program effective July 15, 2025.

Preferred and non-preferred product lists updated for multiple categories including ESA, antiemetics, NK1 agents, and complement inhibitors.

Step Therapy does not apply for other orphan indications; only medical necessity criteria for Soliris per CMS guidance.

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Summary of changes and impact

Florida Blue Medicare updated its Part B Step Therapy program categories for BlueMedicare Medicare Advantage plans effective 2025-07-15. The update refines preferred and non-preferred Part B drugs and associated billing codes across multiple categories (Drug Alternatives; Erythropoiesis-Stimulating Agents; Cancer and Supportive Therapy; Complement Inhibitors; Ophthalmic Agents). The change emphasizes that medical necessity reviews will still apply and that prior authorization may be required for preferred alternatives or non-preferred drugs under the Step Therapy program.

Part B Step Therapy — Quick summary

Effective date2025-07-15

Categories updated/added4

HCPCS/J-codes referencedmultiple

ScopeUpdates to Florida Blue Medicare Part B Step Therapy program: one category removed and three categories added/updated (Drug Alternatives, Cancer and Supportive Therapy, Complement Inhibitors, Ophthalmic Agents); identifies preferred and non-preferred products and associated HCPCS/J-codes; medical necessity reviews still apply.

Material changes in this bulletin

Material changes: One category was removed and three categories were added/updated to the Part B Step Therapy program effective July 15, 2025 (document-level summary).

Updated preferred/non-preferred lists include erythropoiesis-stimulating agents where Retacrit (Q5106) is preferred and Procrit/Epogen/Aranesp/Mircera (J0885, J0881, J0888) are non-preferred.

Cancer and supportive therapy lists were revised: preferred injectable antiemetics include J1626, J2405, J2469 (granisetron, ondansetron, palonosetron) and fosaprepitant (J1453); non-preferred entries include Sustol, Posfrea and codes such as J1627, J2468, J1434 (with a transcription-like entry 'JO185' adjacent in the source).

Complement inhibitor mappings were updated: preferred products include J1303 (Ultomiris), J9332/J9334/J9333 (Vyvgart, Vyvgart Hytrulot, Rystiggo); non-preferred listings include Soliris and related products mapped to codes including J1300, J1299, J1307, Q5152, Q5151, J3490, J3590, C9399. The document clarifies that Step Therapy does not apply for other orphan indications and that only medical necessity criteria apply for Soliris per CMS guidance.

Updated HCPCS / J-code groupings

Erythropoiesis-Stimulating Agents - PreferredHCPCS|CPT|mixedCovered

Q5106

Retacrit

Erythropoiesis-Stimulating Agents - Non-PreferredHCPCS|mixedNot Covered

J0885	Procrit/Epogen (listed)
J0881	Aranesp (listed)
J0888	Mircera (listed)

Cancer and Supportive Therapy - PreferredHCPCSCovered

J1626	granisetron
J2405	ondansetron (injectable)
J2469	palonosetron
J1453	fosaprepitant

Cancer and Supportive Therapy - Non-PreferredHCPCSNot Covered

J1627	Sustol (granisetron) listed as non-preferred
J2468	Posfrea (listed as non-preferred)
J1434	Focinvez / Cinvanti (listed)
JO185	Document lists 'JO185' adjacent to J1434 (appears to be a transcription in the source)

Complement Inhibitors - PreferredHCPCS|CPT|mixedCovered

J1303	Ultomiris (preferred for multiple indications)
J9332	Vyvgart (preferred)
J9334	Vyvgart Hytrulot (preferred listed)
J9333	Rystiggo (preferred)
C9399	Miscellaneous drug code used for certain products (listed as preferred for Empaveli/Enspryng)
J1823	Uplizna (listed)

Complement Inhibitors - Non-PreferredHCPCS|mixedNot Covered

J1300	Soliris (listed as non-preferred)
J1299	Listed non-preferred code
J1307	Listed non-preferred code
Q5152	Non-preferred product code
Q5151	Non-preferred product code
J3490	Unclassified drug code (used for some non-preferred listings)
J3590	Unclassified biologics/other
C9399	Also appears in non-preferred mappings in source

Miscellaneous codes referencedmixed

C9399

Appears both as preferred and non-preferred mapping in document

Step Therapy requirements and clinical criteria

General Step Therapy requirement

Step Therapy is required and the definition of medical necessity must be met; for certain nonpreferred medications consider prescribing preferred alternatives (prior authorization may apply).

Step Therapy applies: Step Therapy requirement applies
Medical necessity: Definition of medical necessity must be met
Encourage preferred alternatives: For certain non-preferred medications, prescribing preferred alternatives is encouraged; prior authorization may apply

Erythropoiesis Stimulating Agents (ESA)

Preferred and non-preferred products and associated codes

What clinicians and billing teams must do

Prior Authorization

Prior authorization may apply

Prior authorization may be required for preferred alternatives or non-preferred Part B drugs per Step Therapy program; medical necessity reviews continue to apply for each drug.

Affected categories: Drug Alternatives; Erythropoiesis-Stimulating Agents; Cancer and Supportive Therapy; Complement Inhibitors; Ophthalmic Agents
Effective date: 2025-07-15
Note: Prior authorization may apply to preferred or non-preferred Part B drugs

Documentation Required

Medical necessity documentation

Medical necessity criteria must be met and documented; for Soliris orphan indications follow CMS guidance for medical necessity.

Soliris (J1300) is listed as non-preferred in Complement Inhibitors

Key definitions

Step Therapy: A program requiring trials of preferred alternatives prior to coverage of non-preferred medications, subject to medical necessity. This requirement applies across the updated categories; medical necessity must be met and prior authorization may apply for preferred or non-preferred Part B drugs.

Document changes and effective date

2025-07-15effective_dateLatest

Updates to Part B Step Therapy categories effective 2025-07-15

2025-07-15category_change

One category removed and three categories added/updated to the Part B Step Therapy program effective July 15, 2025.

2025-07-15category_change

Complement Inhibitors

Preferred and non-preferred complement inhibitor products and HCPCS/CPT/other codes; indications noted

Preferred products (general): Preferred products: Ultomiris, Vyvgart, Vyvgart Hytrulot, Rystiggo
Codes: J1303, J9332, J9334, J9333; Indication: Myasthenia gravis (gMG) for listed preferred products
Non-preferred products (general): Non-preferred products: Soliris, PiaSky, Bkemv, Epysqli, Imaavy
Codes: J1300, J1299, J1307, Q5152, Q5151, J3490, J3590, C9399
PNH: Empaveli and Ultomiris preferred for PNH
Codes: C9399, J3490, J1303; Non-preferred for PNH: Soliris, PiaSky, Bkemv, Epysqli, Imaavy with codes J1300, J1299, J1307, Q5152, Q5151, J3490, J3590, C9399
aHUS: Ultomiris preferred for atypical HUS (aHUS)
Code: J1303; Non-preferred alternatives listed with codes J1300, J1299, J1307, Q5152, Q5151, J3490, J3590, C9399
NMOSD: Enspryng, Uplizna, Ultomiris preferred for NMOSD
Codes: C9399, J1823, J1303; Non-preferred alternatives listed with codes J1300, J1299, J1307, Q5152, Q5151, J3490, J3590, C9399
Orphan indications exempt from Step Therapy: Step Therapy does not apply for other orphan indications
Other orphan indications: dermatomyositis, shiga-toxin producing E. coli HUS, idiopathic membranous glomerular nephropathy, prevention of delayed graft rejection in renal transplant
CIDP and other notes: Vyvgart Hytrulo is non-preferred for CIDP indication; Imaavy is currently indicated for Myasthenia gravis (gMG)