CurrentFlorida BluePolicy N/A

Medicare Advantage Part B Step Therapy — New and Updated Categories

Defines updates to Florida Blue Medicare Advantage Part B Step Therapy categories and preferred vs non-preferred products for certain infused and specialty drugs; affects prescribers and prior authorization for BlueMedicare members.

Policy Summary

PayerFlorida Blue

PolicyMedicare Advantage Part B Step Therapy — New and Updated Categories

Policy CodePolicy N/A

Change TypeOperational — added and updated categories

Effective DateOct 1, 2024

Next Review DateN/A

Key ActionWhen prescribing non-preferred Part B drugs, document indication and prior trial of preferred alternatives and obtain prior authorization when required.

SourceLink

POLICY UPDATE CHANGES

Two new categories (Drug Alternatives, Immune Globulins) and one updated category (Complement Inhibitors / Iron Supplementation agents listed) were added to the Part B Step Therapy program effective October 1, 2024.

3categories added/updated

14IVIG products listed

10Iron supplementation codes

1Complement inhibitor updates

General Step Therapy coverage criteria

Covered when Step Therapy requirements and medical necessity are met for preferred products; non-preferred products require Step Therapy justification or prior authorization.

Step Therapy requirement: Step Therapy is required and the definition of medical necessity must be met for certain non-preferred medications.

Providers are encouraged to consider preferred alternatives; prior authorization may apply

Drug Alternatives - preferred vs non-preferred

Immune Globulins (IVIG): Preferred IVIG products: Gammagard liquid; Gammaked; Gamunex-C; Privigen; Octagam (HCPCS: J1569, J1561, J1459, J1568). Non-preferred IVIG products: Alyglo; Asceniv; Bivigam; Gammagard SID; Panzyga (HCPCS: J1599, J1554, J1556, J1566, J1576).
Subcutaneous Immune Globulins (SCIG): Preferred SCIG products: Cutaquig; Hizentra; HyQvia (HCPCS: J1551, J1559, J1575). Non-preferred SCIG products: Cuvitru; Xembify (HCPCS: J1555, J1558).
Iron Supplementation Agents: Feraheme (ferumoxytol) preferred (Q0138, Q0139); Injectafer listed as non-preferred (J1439). Ferrlecit (sodium ferric gluconate) preferred (J2916); Monoferric listed non-preferred (J1437). Infed preferred (J1750). Triferic preferred (J1443, J1444, J1445). Venofer preferred (J1756).
Complement Inhibitors: Preferred products for PNH: Empaveli, Ultomiris, PiaSky (HCPCS/CPT: C9399, J3490, J1303, J3590). Non-preferred product: Soliris (J1300).
Indication: Paroxysmal Nocturnal Hemoglobinuria (PNH). No changes to preferred/non-preferred products for other indications in the Complement Inhibitor Step Therapy program.

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No changes have been made to the mapping of preferred versus non-preferred products for indications other than Paroxysmal Nocturnal Hemoglobinuria (PNH) within the Complement Inhibitor Step Therapy program. This means existing preferred/non-preferred designations for other indications remain in effect and are unchanged by this update.

Coding — HCPCS / J-Codes and Mappings

Immune Globulins (IVIG and SCIG) - preferred and non-preferredHCPCS

J1569	IVIG preferred product code
J1561	IVIG preferred product code
J1459	IVIG preferred product code
J1568	IVIG preferred product code
J1599	IVIG non-preferred product code
J1554	IVIG non-preferred product code
J1556	IVIG non-preferred product code
J1566	IVIG non-preferred product code
J1576	IVIG non-preferred product code
J1551	SCIG preferred product code

1–10 of 14

1/2

Iron Supplementation Agents - preferred and non-preferredHCPCS|Q

Q0138	Feraheme preferred product code
Q0139	Feraheme preferred product code
J1439	Feraheme non-preferred product code
J2916	Ferrlecit preferred product code
J1437	Ferrlecit non-preferred product code
J1750	Infed preferred product code
J1443	Triferic preferred product code
J1444	Triferic preferred product code
J1445	Triferic preferred product code
J1756	Venofer preferred product code

Complement Inhibitors (PNH indication referenced)HCPCS

C9399	Empaveli/Ultomiris/PiaSky preferred product code
J3490	Empaveli/Ultomiris/PiaSky preferred product code
J1303	Empaveli/Ultomiris/PiaSky preferred product code
J3590	Empaveli/Ultomiris/PiaSky preferred product code
J1300	Soliris non-preferred product code

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Step Therapy requires prior authorization where applicable and the definition of medical necessity must be met. If Step Therapy is not satisfied, services may be denied or prior authorization will be required.

Step Therapy applies to specified non-preferred medications; prescribing a preferred alternative may avoid prior authorization.
Prior authorization and medical necessity documentation are required for non-preferred Part B drugs when Step Therapy is not met.

Step Therapy

Step Therapy Requirement

When a non-preferred drug is requested, prescribers are encouraged to trial one of the listed preferred alternatives first. Non-preferred Part B drugs are subject to the Step Therapy requirement and may be denied without an appropriate trial of preferred agents.

Examples of preferred alternatives include select IVIG, SCIG, iron, and complement inhibitor products listed in the policy.
If a preferred agent is clinically inappropriate, document the reason and submit supporting clinical information with the prior authorization request.

Documentation Required

Documentation and Coding

Document the clinical indication, prior therapeutic trials (drug name, dose, dates, and response or intolerance), and rationale for using a non-preferred Part B drug. Include applicable HCPCS/J‑codes on the request and claim to expedite review.

For IVIG preferred products use codes: J1569, J1561, J1459, J1568. Non-preferred IVIG codes include: J1599, J1554, J1556, J1566, J1576.
For SCIG preferred products use codes: J1551, J1559, J1575. Non-preferred SCIG codes include: J1555, J1558.
For ferumoxytol (Feraheme) preferred codes: Q0138, Q0139; non-preferred example: J1439 (Injectafer).
For sodium ferric gluconate (Ferrlecit) preferred: J2916; non-preferred example: J1437 (Monoferric).
For other injectable iron products use the appropriate J‑code (e.g., J1750, J1756, J1443/J1444/J1445) and document product-specific details.
For complement inhibitors, note preferred product coding (e.g., C9399, J3490, J1303, J3590) and non-preferred coding (e.g., J1300 for Soliris) and indicate the treated indication (e.g., PNH).

Denial Risk

Denial Risk if Step Therapy Not Met

Failure to meet Step Therapy prerequisites or to provide required documentation and coding information increases the risk of denial or the need for retroactive prior authorization.

Claims for non-preferred products submitted without prior authorization or supporting clinical rationale may be denied.
If denied, appeals should include the missing documentation showing medical necessity and prior trials of preferred agents.

Definitions

Step Therapy — definition and key points

DefinitionStep Therapy: a program requiring trial of preferred alternative(s) before coverage of certain non‑preferred medications; the definition of medical necessity must be met.

Provider expectationProviders are encouraged to prescribe listed preferred alternatives for relevant Part B categories instead of non‑preferred products.

Prior authorizationPrior authorization may apply for non‑preferred medications when Step Therapy requirements are not met.

Coverage conditionCoverage is available when Step Therapy requirements and medical necessity criteria are satisfied for the preferred product(s).

Consequence of noncomplianceUse of non‑preferred medications without meeting Step Therapy requirements may lead to denial or require prior authorization.

Step Therapy — Operational Guidance

Provider Guidance	Coverage
Providers are encouraged to prescribe preferred products listed for each category (for example, preferred IVIG/SCIG, iron supplementation agents, and complement inhibitors) when clinically appropriate.
Covered when Step Therapy requirements and the definition of medical necessity are met for preferred products; non-preferred products are subject to Step Therapy and may require prior authorization.
When prescribing a non-preferred Part B medication, document the indication and prior trial(s) of preferred alternatives; include the applicable HCPCS/J- codes for billing and prior authorization requests.
Use of non-preferred medications without meeting Step Therapy requirements and medical necessity criteria may require prior authorization and could be denied.

OpenPayer

Medicare Advantage Part B Step Therapy — New and Updated Categories

Coverage Criteria

Coding — HCPCS / J-Codes and Mappings

Provider Actions and Requirements

Definitions

Background

Step Therapy — Operational Guidance