Rituximab and Biosimilars (Rituxan, Ruxience, Truxima, Riabni) — Medical Benefit Prior Authorization
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Defines Aloha Care medical benefit coverage, prior authorization, step therapy, and clinical criteria for rituximab and its biosimilars for Medicare and Medicaid populations.
Moved to a new template.
Added Medicare continuity of care requirement.
Coverage Criteria for Rituximab Products
PA clinical criteria
Covered when ALL of the following diagnosis‑specific and provider criteria are met:
ALL of the following
- Prescribed or recommended by a Rheumatologist
- Diagnosis of Rheumatoid Arthritis (for Rituxan)
- Request is for new therapy AND the member has a documented inadequate trial (minimum 3 months) of methotrexate unless contraindicated, demonstrated by increased tender/swollen joint count, pain, or inflammatory markers (ESR or CRP).
- Rituximab is being used concurrently with methotrexate unless methotrexate is contraindicated.
Medicaid biosimilar requirement (Medicaid only)
- For Medicaid: member has inadequate response to Ruxience and Riabni.
- For Medicaid: member has intolerable adverse event to Ruxience and Riabni.
- For Medicaid: member has a contraindication to Ruxience and Riabni.
ALL of the following
- Diagnosis of NHL or CLL (e.g., ICD C85–C85.99, C91.1) (rituximab approved for this indication).
- Prescribed or recommended by an Oncologist or Hematologist/Oncologist.
- Continuation allowed with previous approved prior authorization on file or claims history.
Medicaid biosimilar requirement (Medicaid only)
- For Medicaid: member has inadequate response to Ruxience and Riabni.
- For Medicaid: member has intolerable adverse event to Ruxience and Riabni.
- For Medicaid: member has a contraindication to Ruxience and Riabni.
ALL of the following
- Diagnosis of GPA (Wegener's) or MPA (for Ruxience or Rituxan).
- Prescribed or recommended by an appropriate specialist (Hematologist, Pulmonologist, ENT/Otolaryngologist, Nephrologist, Rheumatologist or other relevant specialist).
- Continuation of therapy with previous approved prior authorization on file or claims history.
- Rituxan is being used concurrently with glucocorticoids (such as prednisone).
ALL of the following
- Diagnosis of ITP (for Rituxan).
- Prescribed or recommended by a Hematologist or Hematologist/Oncologist.
- Member is at risk of spontaneous bleeding, demonstrated by either platelet count <20,000/mm3 OR platelet count <30,000/mm3 with bleeding symptoms.
- Previously failed first-line corticosteroid therapy (e.g., prednisone 1–2 mg/kg for 2–4 weeks or pulse dexamethasone 40 mg daily for 4 days) unless contraindicated or not tolerated.
Medicaid biosimilar requirement (Medicaid only)
- For Medicaid: member has inadequate response to Ruxience and Riabni.
- For Medicaid: member has intolerable adverse event to Ruxience and Riabni.
- For Medicaid: member has a contraindication to Ruxience and Riabni.
Initial therapy criteria
Initial authorization is considered when the following requirements are met:
Medicaid biosimilar requirement (Medicaid only)
- For Medicaid: documented inadequate response to Ruxience and Riabni.
- For Medicaid: documented intolerable adverse event to Ruxience and Riabni.
- For Medicaid: documented contraindication to Ruxience and Riabni.
Continuation and Reauthorization Requirements
Continuation requirements
Continuation/re‑authorization is allowed when the following are met:
May be requested per medical review.
Billing and Coding for Rituximab Products
Provider Responsibilities, Prior Authorization, and Medicare-specific Actions
Prior authorization required; list of billing codes and approval durations
Medical benefit prior authorization is required for rituximab and its biosimilars; these products are excluded on the pharmacy benefit. Initial prior authorization is issued for 3 months; reauthorization is 12 months. Covered HCPCS/Q-codes include J9312 (rituximab) and biosimilar Q-codes Q5115 (Truxima), Q5119 (Ruxience), and Q5123 (Riabni).
Medicare Part B review rules, Optum Health transition, and 90-day continuity
Medicare Part B requests must be reviewed using the most current LCD, NCD, or LCA applicable to the Hawaii region. Effective 4/1/2026, all chemotherapy indications will be reviewed by Optum Health. For new Medicare Part B starts, step therapy criteria must be met in addition to clinical criteria; however, a 90-day transition period allows new Medicare members already on an active course to continue without meeting Coverage and Step Therapy during the first 90 days of enrollment.
- Use current LCD/NCD/LCA for Hawaii when adjudicating Medicare Part B requests.
- Optum Health will review chemotherapy indications effective 4/1/2026.
- New starts: Medicare Part B step therapy required in addition to coverage criteria.
- 90-day transition: existing active courses for new Medicare members are exempt from Coverage and Step Therapy for the first 90 days of enrollment.
Specialist prescription/recommendation and documentation requirements
Certain indications require the medication to be prescribed or recommended by a specialist; documentation of specialty involvement and relevant clinical data must be provided with the request (e.g., rheumatologist for RA; oncologist/hematologist for NHL/CLL; hematologist for ITP; appropriate specialists for GPA/MPA).
- Rheumatoid arthritis: prescribed or recommended by a Rheumatologist and documentation of prior MTX trial when applicable.
- NHL/CLL: prescribed or recommended by an Oncologist or Hematologist/Oncologist; continuation allowed with prior authorization or claims history.
- GPA/MPA: prescribed or recommended by a Hematologist, Pulmonologist, ENT, Nephrologist, Rheumatologist, or other appropriate specialist.
- ITP: prescribed or recommended by a Hematologist or Hematologist/Oncologist and supporting platelet count and prior therapy failure documentation.
Site of Care and Infusion Setting
Infusions billed under medical benefit; Medicare Part B follows LCD/NCD/LCA
Rituximab products are infused under the medical benefit; outpatient infusions for Medicare Part B must follow applicable LCD/NCD/LCA. Note that chemotherapy indications will be reviewed by Optum Health beginning 4/1/2026.
- Site of care: infusion center; billed as medical benefit (Part B for Medicare outpatient infusion)
- Medicare Part B coverage and coding must align with current LCD/NCD/LCA
Step Therapy Requirements
| Step | Requirement | Notes |
|---|---|---|
| 1 | Medicare Part B step therapy must be met for new starts in addition to coverage criteria | Per policy: For new starts, Medicare Part B Step Therapy Criteria must be met before approval; applies in addition to standard coverage criteria. |
| 2 | For new starts of Rituxan or Truxima: trial and inadequate response, intolerance, or contraindication to preferred biosimilars Ruxience and Riabni required | Policy specifies Rituxan and Truxima new starts require documented inadequate response to, intolerable adverse event to, or contraindication for Ruxience and Riabni. |
| 3 | Step therapy requirement is applied in addition to all other PA coverage criteria (diagnosis, specialist involvement, prior therapy trials) | Coverage criteria include diagnosis-specific requirements, specialist prescribing, and prior therapy trials (e.g., MTX trial for RA); step therapy does not replace these criteria. |
Biosimilar Preference and Substitution Guidance
Preferred biosimilars; Medicaid requires failure/intolerance to preferred agents for Rituxan/Truxima
Ruxience (rituximab-pvvr) and Riabni (rituximab-arrx) are listed as preferred biosimilars. For Medicaid members, use of Rituxan or Truxima requires documentation of inadequate response to, intolerable adverse event from, or contraindication to Ruxience and Riabni.
Definitions and Medicare Transition Notes
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