Step Therapy Requirements for Provider Administered Specialty Medications
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Defines step therapy requirements for provider-administered specialty drugs, including preferred alternative agents and applicable billing codes; affects providers who administer specialty medications for Blue Cross Blue Shield licensees (Minnesota).
No material clinical or coverage changes in this revision.
Coverage and Step Therapy Criteria
inv-01: General coverage prerequisites
Coverage for a provider-administered specialty medication is allowed when ALL of the following are met:
From policy introduction
inv-02: Drug-specific step therapy
For each listed drug, coverage requires following the specific step:
See drug-by-drug table entries
Several table entries identify oncology exceptions where the usual preferred-alternative step is different or does not apply. For example, certain products listed in the table (e.g., some viscosupplement and infliximab entries) include a specific note: “For oncology indications only — = Inflectra” or list alternative oncology-specific products such as Mvasi or Zirabev as the designated option. Providers should follow the table’s row-level oncology notation when the requested use is for an oncology indication.
Use of a provider-administered specialty medication without first meeting the policy’s step therapy requirements (i.e., when a listed preferred alternative or biosimilar has not been tried as required by the table) is not supported by this policy and may be considered not medically necessary. Requests are subject to prior authorization and may be denied if the step therapy prerequisites are not documented.
Initial Therapy Requirements
inv-14: Initial therapy requirement
Initial therapy rules from the table
Drug-specific table entries
Continuation Therapy
inv-15: Continuation therapy
Continuation requires ongoing adherence to indication and dose limits.
Policy general rule
Step Therapy Table and Rules
| Requested Provider‑Administered Specialty Medication | Preferred alternative(s) (member must try one unless noted) | Notes / exceptions |
|---|---|---|
| Aralast NP (J0256) | Prolastin C | |
| Glassia (J0257) | Zemaira | |
| Soliris (J1299) | Ultomiris (J1303) | |
| Actemra IV (J3262) | No preferred alternative listed | |
| Avzivi (J9035 / Q5107 / Q5118) | For oncology indications: Mvasi or Zirabev | Oncology exception — different alternatives specified |
| Hyaluronic acid viscosupplements (J7320, J7321, J7322, J7327) | Preferred alternatives vary; examples include GenVisc 850, Hyalgan, Hymovis; for oncology indications Synvisc/Synvisc One or Euflexxa may be listed | Some entries note oncology-specific alternatives |
| Infliximab products (J1745 and related Q-codes) | Biosimilar alternatives such as Avsola / Inflectra noted where applicable | Oncology indications may have different listed alternatives |
| Stimulating products (e.g., Rolvedon J1449; Nyvepria Q5122; Ryzneuta J9361) | Biosimilar or Rolvedon for certain indications; Neulasta/Neulasta OnPro and similar agents referenced as alternatives | Specific agent-level notes apply (see table) |
| Retinal disorder agents (Eylea J0178/J0177; Lucentis J0179; Eydenzelt/Q5150; Enzeevu/Q5149) | Avastin (J2778) is listed as the initial preferred agent; then one of the listed higher‑cost agents may be trialed | Avastin-first requirement for certain retinal agents; see agent-specific rows |
| Rituximab products (Q5115, Q5119; Riabni Q5155; Riabni J9312) | Preferred rituximab biosimilars/products are listed (e.g., Truxima, Ruxience); trial of designated biosimilar/product required | |
| Trastuzumab products (J9355, J9356; Q5146, Q5113) | Preferred trastuzumab products/biosimilars are listed (e.g., Trazimera, Kanjinti); trial of designated agent is required except as noted | See table for indication‑specific exceptions |
Relevant Billing and Product Codes
What Providers Must Do
Prior Authorization Required
Prior authorization is required per step therapy. Members must have tried the listed preferred alternatives before coverage of the requested provider-administered specialty medication.
- Prior authorization required for provider-administered specialty drugs subject to step therapy
- Coverage contingent on trying designated preferred alternative(s) listed in the step therapy table
Step Therapy Requirement
Providers must follow the step therapy table and the designated preferred alternatives. The member must have tried (and failed, is intolerant to, or has a documented contraindication to) at least one of the listed preferred alternatives prior to approval of the requested specialty drug unless an exception is documented.
- Use the step therapy table to identify required preferred alternative agents for the specific diagnosis and J/Q-code
- If a preferred alternative is not appropriate, document the clinical reason (failure, intolerance, contraindication, or other medical rationale)
Required Documentation
Documentation submitted with the prior authorization request must support the medical indication, dose, frequency, and duration of therapy. Include clinical notes, prior medication trials (dates, doses, responses), laboratory or diagnostic results when applicable, and rationale why preferred alternatives are not appropriate if step therapy was not followed.
- Support indication, dose, frequency, and duration for the requested use
- Provide prior treatment history showing trial(s) of preferred alternative(s) with dates and clinical response
- Include relevant labs, imaging, and clinical notes to justify therapy and to show use does not exceed safety/efficacy limits
Denial for Unmet Step Therapy
Requests that do not meet the step therapy requirements (no documented trial of a required preferred alternative and no documented exception) may be denied.
- Denial may occur if preferred alternative(s) listed in the step therapy table were not tried and no clinical exception is documented
Applicable Site of Care
Policy applies to provider‑administered settings
This policy applies to provider‑administered settings (office/infusion); the document does not impose specific site‑of‑care limitations.
Biosimilar and Retinal Agent Notes
Avastin required as initial preferred retinal agent
For listed retinal agents (Enzeevu, Eydenzelt, Lucentis), Avastin is specified as the initial preferred agent to be tried prior to coverage of higher‑cost agents; the table then allows one of the listed agents after Avastin.
- Enzeevu / Eydenzelt / Lucentis: “Avastin Then one of the following” (table language).
- Retinal agent codes (e.g., J2778 for Avastin) are listed in the table entries referenced.
Key Definitions
Background and Scope
Provider-administered specialty medications span multiple therapeutic areas, including autoimmune disorders, oncology, retinal disorders, and supportive care. The policy requires use of preferred alternatives or biosimilars where specified to align with safety, efficacy, and cost-effective care, and applies when the medication is a provider-administered specialty drug used for a medically accepted indication with appropriate dose, frequency, and duration.
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