Medicare Part B Step Therapy — Colony-Stimulating Factors
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This policy governs updated Step Therapy requirements for certain nonpreferred Part B medications (colony-stimulating factors) for Florida Blue Medicare Advantage (BlueMedicare) plans and informs prescribers of preferred alternatives and prior authorization expectations.
One category was updated for the Part B Step Therapy program for BlueMedicare Medicare Advantage plans effective October 1, 2025.
Coverage Criteria
Coverage contingent on Step Therapy and medical necessity
Covered when Step Therapy and medical necessity requirements are met.
Prescribers may need prior authorization for nonpreferred products.
Per policy, Step Therapy is required for certain nonpreferred Part B medications; prior authorization may apply.
Prescribers should document attempts or consideration of preferred alternatives and meet the medical necessity definition when requesting coverage for nonpreferred drugs.
Use of nonpreferred Part B medications without meeting Step Therapy or medical necessity requirements may trigger prior authorization denial.
The policy does not list any explicit clinical exclusions for Part B colony-stimulating factors. Coverage is conditional: benefits are available when Step Therapy requirements are followed and the payer's definition of medical necessity is satisfied. Nonpreferred products may be excluded if the prescriber has not demonstrated compliance with Step Therapy or documented medical necessity.
If a prescriber requests a nonpreferred Part B colony-stimulating factor without meeting the Step Therapy requirements or without documentation that satisfies medical necessity, the request is implied to be not covered and may be subject to prior authorization denial. Prescribers are encouraged to consider preferred alternatives and to document attempts or rationale when seeking coverage for nonpreferred agents.
Coding and Product Lists
| Neulasta | Non-preferred product (brand name) listed |
| Fylnetra | Non-preferred product listed |
| Rolvedon | Non-preferred product listed |
| Stimufend | Non-preferred product listed |
| Ryzneuta | Non-preferred product listed |
| Nypozi | Non-preferred product listed |
| Ziextenzo | Non-preferred product listed |
| J2506 | HCPCS/J-code listed in non-preferred group |
| Q5130 | HCPCS Q-code listed in non-preferred group |
| J1449 | HCPCS/J-code listed in non-preferred group |
| Q5127 | HCPCS Q-code listed in non-preferred group |
| J9361 | HCPCS/J-code listed in non-preferred group |
| Q5148 | HCPCS Q-code listed in non-preferred group |
| Q5120 | HCPCS Q-code listed in non-preferred group |
Provider Actions and Requirements
Step Therapy Required
Step Therapy is required for certain nonpreferred Part B colony-stimulating factor products. Prescribers should consider and attempt preferred alternatives prior to initiating nonpreferred agents; prior authorization may still be required for preferred products.
- Preferred alternatives may be subject to prior authorization.
- Additions to non-preferred products are noted in the policy and must be checked at time of prescribing.
Documentation Expectations
Prescribers must document attempts or clinical consideration of preferred alternatives when requesting a nonpreferred colony-stimulating factor. Requests for nonpreferred agents must meet the plans definition of medical necessity to be approved.
- Document trial of preferred product(s) or rationale why preferred products are not appropriate.
- Include clinical notes, prior medication history, and relevant lab results to support medical necessity.
Prior Authorization and Denial Risk
Prior authorization may be required for nonpreferred colony-stimulating factor products. If Step Therapy requirements or the plans medical necessity criteria are not met, the request may be denied.
- Nonpreferred Part B colony-stimulating factors are subject to denial if Step Therapy or medical necessity is not satisfied.
- Check members benefit and prior authorization status before administering or billing.
Specific Product Guidance
Examples of preferred and non-preferred colony-stimulating factor products are listed in the policy. Prescribers must consider preferred products (listed below) before non-preferred agents.
Initial Therapy Criteria
Preferred alternatives recommended
Preferred-first approach — prescribers should consider listed preferred products before nonpreferred agents.
Prior authorization may apply for preferred or nonpreferred agents.
Preferred products listed in policy.
Additions to non-preferred products are highlighted in the source.
Step Therapy Details
| Step | Requirement | Preferred alternatives (HCPCS/Codes) | Non-preferred products / codes | Provider action |
|---|---|---|---|---|
| 1 | Prescribers must consider and attempt preferred alternatives before initiating non-preferred Part B colony-stimulating factor products. Step Therapy and the payer's medical necessity requirements must be met. | Fulphila (Q5108); Udenyca (Q5111); Nyvepria (Q5122) | Neulasta; Fylnetra; Rolvedon; Stimufend; Ryzneuta; Nypozi; Ziextenzo; and related non-preferred codes: J2506; Q5130; J1449; Q5127; J9361; Q5148; Q5120 | Document attempts or clinical rationale for preferred alternatives; prior authorization may apply for non-preferred agents and coverage is contingent on meeting Step Therapy and medical necessity criteria. |
Biosimilar and Preferred Product Guidance
Preferred products: Fulphila, Udenyca, Nyvepria
Fulphila, Udenyca, and Nyvepria are identified as the preferred colony-stimulating factor products (Q5108, Q5111, Q5122); other listed agents (e.g., Neulasta, Fylnetra, Rolvedon, Stimufend, Ryzneuta, Nypozi, Ziextenzo and related J/Q codes) are non-preferred and subject to Step Therapy.
Definitions
Background
Colony-stimulating factors are agents used to reduce infection risk by stimulating neutrophil production in patients with neutropenia, commonly in the setting of chemotherapy. The Step Therapy program encourages use of preferred agents first when clinically appropriate, with exceptions allowed when medical necessity is documented.
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