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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsFlorida Blue Medicare Part B Step Therapy Policy U…
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    CurrentFlorida BluePolicy N/A

    Medicare Part B Step Therapy — Pharmacy & Specialty Drugs coverage criteria

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    Updates to Florida Blue Medicare Part B Step Therapy categories, adding three new categories and revising preferred and non-preferred product lists; applies to Florida Blue Medicare plans and providers prescribing Part B drugs.

    Policy Summary
    PayerFlorida Blue
    PolicyMedicare Part B Step Therapy — Pharmacy & Specialty Drugs coverage criteria
    Policy CodePolicy N/A
    Change TypeAdded categoriesupdated product lists
    Effective DateJan 1, 2025
    Next Review Date
    Key ActionPrescribers must follow Part B Step Therapy and consider preferred alternatives (obtain prior authorization when required).
    SourceLink
    POLICY UPDATE CHANGES

    Three new categories were added to the Part B Step Therapy program effective January 1, 2025.

    Multiple preferred and non-preferred product lists were updated across categories (Asthma Therapy, Autoimmune Therapy, Immune Globulin agents, Colony Stimulating Factors, Complement Inhibitors, IVIG, Ophthalmic Agents).

    3new Part B Step Therapy categories added
    5categories updated
    multipleproduct lists changed

    Coverage Criteria

    General Part B Step Therapy criteria

    Covered when ALL of the following are met:

    Step Therapy general requirement: Step Therapy is required and the payer's definition of medical necessity must be met; preferred alternatives should be considered and prior authorization may apply.

    Applies across Part B Step Therapy categories

    Coding and HCPCS/CPT/NDC Lists

    Asthma TherapyHCPCS
    J0517Preferred Product (Asthma Therapy)
    J2182Preferred Product (Asthma Therapy)
    J2786Non-Preferred Product (Asthma Therapy)
    Autoimmune Therapy / Infliximab groupHCPCS
    Q5135Preferred Product (Autoimmune Therapy)
    J3262Non-Preferred Product (Autoimmune Therapy)
    Q5133Non-Preferred Product (Autoimmune Therapy)
    Q5121Preferred Product (Avsola/Inflectra/Infliximab/Remicade group)
    Q5103Preferred Product (Avsola/Inflectra/Infliximab/Remicade group)
    J1745Preferred Product (Avsola/Inflectra/Infliximab/Remicade group)
    Q5104Non-Preferred Product (Avsola/Inflectra/Infliximab/Remicade group)
    J1748Non-Preferred Product (Avsola/Inflectra/Infliximab/Remicade group)
    Policy Summary
    PayerFlorida Blue
    PolicyMedicare Part B Step Therapy — Pharmacy & Specialty Drugs coverage criteria
    Policy CodePolicy N/A
    Change TypeAdded categoriesupdated product lists
    Effective DateJan 1, 2025
    Next Review Date
    Key ActionPrescribers must follow Part B Step Therapy and consider preferred alternatives (obtain prior authorization when required).
    SourceLink
    On This Page
    Coverage CriteriaCoding and HCPCS/CPT/NDC ListsWhat Providers Must DoBackgroundDefinitionsStep Therapy Product Preference TablesBiosimilar / Infliximab Notes
    Immune Globulin / IVIGHCPCS
    J1561Preferred Product (Immune Globulin agents / IG)
    J1459Preferred Product (Immune Globulin agents / IG)
    J1559Preferred Product (Immune Globulin agents / IG)
    J1568Preferred Product (IVIG)
    J9332Non-Preferred Product (Immune Globulin agents)
    J1599Non-Preferred Product (IVIG)
    J1554Non-Preferred Product (IVIG)
    J1556Non-Preferred Product (IVIG)
    J1566Non-Preferred Product (IVIG)
    J1576Non-Preferred Product (IVIG)
    1–10 of 11
    1/2
    Multiple categories (Colony Stimulating Factors, Complement Inhibitors, Ophthalmic Agents)HCPCS
    Q5112Preferred product code (used across several categories)
    Q5116Preferred product code (used across several categories)
    Q5117Preferred product code (used across several categories)
    J9355Non-Preferred Product code (multiple categories)
    J9356Non-Preferred Product code (multiple categories)
    Q5146Non-Preferred Product code
    Q5113Non-Preferred Product code
    Q5114Non-Preferred Product code
    J2506Non-Preferred Product (Colony Stimulating Factors list)
    Q5130Non-Preferred Product
    1–10 of 27
    1/3
    inv-06: Effective Date
    Effective dateJanuary 1, 2025
    Applies toFlorida Blue Medicare plans
    ScopeUpdates to Part B Step Therapy categories including three new categories

    What Providers Must Do

    Step Therapy

    Part B Step Therapy Required

    Step Therapy is required for certain Part B medications. Providers should follow the Step Therapy pathway and consider prescribing preferred alternatives when appropriate. Prior authorization may still be required for preferred products; ensure the definition of medical necessity is met and submit supporting documentation with any authorization request.

    • Step Therapy requirement applies to multiple Part B drug categories listed below.
    • When a non-preferred product is requested, consider a preferred alternative first; prior authorization policies still apply.
    Step Therapy

    Step Therapy Requirement — Affected Categories

    Step Therapy applies across multiple drug categories. The following lists indicate preferred and non-preferred products by HCPCS/CPT codes — prescribers should use preferred agents when clinically appropriate and follow any PA requirements.

    • Applies to Asthma Therapy, Autoimmune Therapy, Immune Globulin/IVIG, Colony Stimulating Factors, Complement Inhibitors, Ophthalmic Agents, and other updated Part B categories.
    • Preferred and non-preferred products are identified below by product name and HCPCS/CPT codes.
    Documentation Required

    Documentation and Prior Authorization

    Providers must document clinical rationale in the medical record when requesting non-preferred Part B drugs. Submit all relevant clinical documentation with any prior authorization request to demonstrate medical necessity and why preferred alternatives are not appropriate.

    • Include diagnosis, prior treatment history, reason preferred agents are unsuitable, and supporting labs/imaging where applicable.
    • Use Florida Blue prior authorization processes and forms; incomplete documentation may delay review.
    Denial Risk

    Denial Risk for Non-Preferred Part B Drugs

    Requests for non-preferred Part B drugs that do not meet Step Therapy and prior authorization requirements are at risk for denial. Prescribers should ensure Step Therapy has been followed or provide adequate justification and documentation for exceptions.

    • Denial may occur when a required trial of preferred therapy is not documented.
    • Denial risk increases if prior authorization is missing or medical necessity criteria are not met.
    Step Therapy

    Asthma Therapy — Preferred vs Non-Preferred

    Asthma Therapy: Preferred products include J0517 and J2182 (e.g., Fasenra, Nucala). Non-preferred products include Cinqair and J2786. Consider preferred agents first and attach supporting documentation if requesting a non-preferred product.

    • Preferred: J0517, J2182
    • Non-Preferred: Cinqair, J2786
    Step Therapy

    Autoimmune Therapy — Preferred vs Non-Preferred

    Autoimmune Therapy: Preferred products include Q5135 and biosimilars Q5121/Q5103 (e.g., Avsola/Inflectra/unbranded infliximab/Remicade). Non-preferred products include Actemra, Tofidence, J3262, Q5133, Renflexis, Zymfentra, Q5104, and J1748. Use preferred biosimilars when clinically appropriate and follow PA rules.

    • Preferred: Q5135; Q5121, Q5103, J1745
    • Non-Preferred: Actemra, Tofidence, J3262, Q5133, Renflexis, Zymfentra, Q5104, J1748
    Step Therapy

    Immune Globulin / IVIG — Preferred vs Non-Preferred

    Immune Globulin/IVIG and related agents: Preferred products include J1561, J1459, J1559 (e.g., Gammaked, Gamunex, Privigen, Hizentra) and listed IVIG preferred products (Gammagard liquid, Gammaked, Gamunex-C, Privigen, Octagam). Non-preferred products include Vyvgart, Hytrulo, and a range of other IVIG/immune globulin products and codes listed below. Ensure indication (e.g., CIDP) is documented and preferred agents are trialed where indicated.

    • Preferred (IG/IVIG): J1561, J1459, J1559; Gammagard liquid, Gammaked, Gamunex-C, Privigen, Octagam
    • Non-Preferred: Vyvgart, Hytrulo; codes J9332 and other IVIG/immune globulin product codes (e.g., J1599, J1554, J1556, J1566, J1576, J3590)

    Background

    This policy describes Florida Blue Medicare’s utilization management Step Therapy program for Medicare Part B–covered biologic and injectable medications. The program groups Part B biologics and injectables into therapeutic categories (for example, Asthma biologics, Autoimmune biologics, Immune globulins/IVIG, Colony Stimulating Factors, Complement inhibitors, and Ophthalmic agents) and designates preferred and non‑preferred products within each category to guide prescribing and claims adjudication. Changes to category membership and preferred/non‑preferred listings — including addition of three new categories — are effective 2025‑01‑01 for Florida Blue Medicare plans.

    Under this utilization management approach, coverage for a requested Part B drug requires that the plan’s Step Therapy rules and the payer’s definition of medical necessity be met. Prescribers are encouraged to consider the listed preferred alternatives (identified by HCPCS/CPT codes in the coding tables) and to obtain prior authorization when required. Prescribing a non‑preferred Part B product without meeting Step Therapy requirements or an approved prior authorization may result in claim denial.

    Definitions

    inv-12: Step Therapy
    DefinitionStep Therapy is a utilization management process requiring trial of preferred alternative drugs and meeting the payer's medical necessity criteria before coverage of non-preferred medications.
    Prescriber actionPrescribers are encouraged to consider preferred alternatives listed by the plan and obtain prior authorization when required.
    ApplicabilityRequired across multiple Part B drug categories covered by Florida Blue Medicare Step Therapy program.
    inv-13: IVIG
    DefinitionIntravenous immune globulin (IVIG) products are grouped under the Immune Globulin/IVIG category with specified preferred and non-preferred products for Step Therapy.
    Preferred examplesGammaked, Gamunex, Privigen, Hizentra (HCPCS: J1561, J1459, J1559)
    Indication notedChronic inflammatory demyelinating polyradiculoneuropathy (CIDP) listed as an indication for certain IVIG products.
    Non-preferred examplesVyvgart Hytrulo and related non-preferred codes (e.g., J9332) are listed as non-preferred within the IVIG group.

    Step Therapy Product Preference Tables

    CategoryPreferred products (HCPCS/CPT)Non‑preferred products (HCPCS/CPT)Prescriber guidance
    Asthma TherapyJ0517, J2182Cinqair, J2786Use preferred products Fasenra/Nucala when appropriate; follow Step Therapy edits and obtain prior authorization if required.
    Autoimmune Therapy — Infliximab groupQ5121, Q5103, J1745Renflexis, Zymfentra, Q5104, J1748Prefer Avsola/Inflectra/Remicade-group products per Step Therapy; document trials of preferred agents before non‑preferred use.
    Autoimmune Therapy — other biologicsQ5135Actemra / related codes J3262, Q5133Prescribe preferred Tyenne (Q5135) when clinically appropriate and follow Step Therapy requirements prior to non‑preferred biologics.
    Immune Globulin / IVIGJ1561, J1459, J1559, J1568Vyvgart / Hytrulo (J9332), and other non‑preferred IVIG codes J1599, J1554, J1556, J1566, J1576, J3590Use preferred IVIG products (Gammaked, Gamunex, Privigen, Hizentra, Gammagard liquid, etc.) per Step Therapy; CIDP indication noted for some preferred agents. Prior authorization may be required.
    Colony Stimulating FactorsQ5112, Q5116, Q5117 (Ontruzant, Trazimera, Kanjinti; Fulphila, Udenyca, Nyvepria, Ziextenzo mappings)Non‑preferred examples include J9355, J9356, Q5146, Q5113, Q5114, J2506, Q5130, J1449, Q5127, J9361, C9399Prefer listed CSF preferred products; document preferred trials or obtain prior authorization before billing non‑preferred agents.
    Complement InhibitorsQ5112, Q5116, Q5117 (preferred mappings to Empaveli, Ultomiris, etc.)Non‑preferred examples include J9355, J9356, Q5146, Q5113, Q5114, J1300, J1307Follow Step Therapy preference for listed complement inhibitors; prior authorization and documentation required for non‑preferred agents.
    Ophthalmic AgentsQ5112, Q5116, Q5117 (preferred mappings include Bevacizumab and related HCPCS)Non‑preferred ophthalmic products include J0179, Q5124, Q5128, J0177, J0178, J2778, J2503, J2779, J2777, J3396, plus branded retinal agents (Beovu, Byooviz, Cimerli, Eylea, Lucentis, etc.)Use preferred ophthalmic products where clinically appropriate and follow Step Therapy edits; obtain prior authorization when required for non‑preferred agents.

    Biosimilar / Infliximab Notes

    Billing Rule

    Remicade (infliximab) preferred vs non-preferred codes

    For infliximab products, the policy lists Avsola/Inflectra/Remicade-group products as preferred (Q5121, Q5103, J1745) and other infliximab products as non-preferred (Q5104, J1748); prescribers should select preferred infliximab products or follow Step Therapy/prior authorization requirements for non-preferred infliximab.

    • Preferred infliximab codes: Q5121, Q5103, J1745.
    • Non-preferred infliximab codes: Q5104, J1748.