Require prior authorization; standard initial validity 6 months

Prior authorization is required. Initial approvals are typically provided for 6 months (180 days) for both oncology and non‑oncology indications unless otherwise specified; some non‑oncology indications (Pemphigus Vulgaris, Systemic Lupus Erythematosus, Lupus Nephritis) receive an initial PA of 12 months. Oncology PAs may be renewed every 6 months up to 2 years unless otherwise stated; certain pediatric oncology and other listed indications are not renewable per the policy.

• Standard initial PA: 6 months (180 days) for oncology and non‑oncology unless specified [[see cited chunks]]
• Select non‑oncology: initial 12 months for PV, SLE, LN
• Oncology renewals: every 6 months up to 2 years unless specified; some oncology indications non‑renewable

Must trial specified biosimilars before other rituximab products

Providers must document that the member has had a contraindication, intolerance, or therapeutic failure to each of the three named rituximab biosimilars—Riabni, Ruxience, AND Truxima—before another rituximab product will be considered.

• Member must have contraindication, intolerance, or failure to Riabni®, Ruxience®, AND Truxima® prior to consideration of another rituximab product

Include prior therapy history, objective severity, and combination rationale

Prior authorization requests must include documentation of prior therapy trials/failures, objective measures of disease severity, and rationale for any combination therapy (e.g., RA requires methotrexate unless contraindicated).

• Document prior treatment trials and failures (e.g., csDMARD trial for RA, prior corticosteroid/immunosuppressive trials for SLE/LN)
• Provide objective disease severity assessments (e.g., PDAI for pemphigus, MRI for MS)
• If requesting combination therapy, include rationale and supporting evidence per prescribing information

Renew only if criteria, duration limits, and safety are satisfied

Renewal of prior authorization is allowed only if the member continues to meet the universal and indication‑specific criteria, duration limits have not been exceeded, and there is absence of unacceptable toxicity.

• Member must continue to meet universal and indication‑specific criteria
• Duration limits per Section I must not be exceeded
• No unacceptable toxicity (examples listed in policy) should be present

Specify indication‑specific dosing regimen on the PA

The prior authorization must specify the indication‑specific dosing regimen requested (examples include 375 mg/m² IV weekly x4–8 for many indications); PA approvals should match the indicated regimen and schedule.

• State the exact regimen (e.g., 375 mg/m² IV weekly x4–8; intra‑CSF dosing where applicable)
• Systemic IV dosing options and renewal schedules (e.g., 375 mg/m² IV once weekly for 4 doses per 6 months) should be reflected in the PA

Include HCPCS J9312, biosimilar Q‑codes, and relevant NDCs

Use the listed billing codes and product identifiers when requesting authorization and for claims: HCPCS J9312 and biosimilar Q‑codes Q5115, Q5119, Q5123, and include the appropriate NDC for the product supplied.

• HCPCS: J9312; Q5115; Q5119; Q5123
• Include NDC for the specific product vial (examples shown in policy Appendix)

References (no PA rules in this excerpt)

This section is reference material only and does not impose prior authorization rules by itself.

CMS local coverage articles cited — may affect billing & PA

CMS Local Coverage Articles relevant to rituximab billing, coding, and off‑label use are cited and may inform prior authorization and reimbursement determinations; providers should follow those LCAs where applicable.

• Local Coverage Articles cited include A59101, A55639, A56380 (see policy references)

PA may be applied based on NQTL factors (indication, safety, cost)

The NQTL checklist indicates prior authorization may be applied because of indication, safety/efficacy, and cost considerations; PA may therefore be required for certain uses.

• Factors considered for PA: indication, safety/efficacy, and drug cost (per NQTL checklist)

Cite a covered ICD‑10 diagnosis from Appendix 1 on PA requests

Prior authorization requests must include an eligible ICD‑10 diagnosis from the policy’s covered‑diagnosis list to establish medical necessity for rituximab.

• Cite one of the Appendix 1 ICD‑10 codes that corresponds to the covered indication when submitting PA and claims

Use Appendix 1 diagnosis codes to support authorization/claims

Appendix 1 lists the covered ICD‑10 diagnosis codes; include one of these codes on the authorization and claim to support coverage.

• Use the specific ICD‑10‑CM code from Appendix 1 that matches the member’s diagnosis

Comply with Medicare Part B NCDs/LCDs and CMS guidance

For Medicare Part B claims, follow CMS guidance and applicable NCDs/LCDs; compliance with local coverage determinations and articles is required where applicable.

• Medicare Part B coverage must follow the Medicare Benefit Policy Manual and applicable NCDs/LCDs/LCAs

Step requirement: trial/intolerance/failure of Riabni, Ruxience, and Truxima

Step therapy requires that the member trial and have contraindication/intolerance or failure to the three named biosimilars—Riabni, Ruxience, and Truxima—before coverage of another rituximab product will be considered.

• Must trial Riabni, Ruxience, AND Truxima (or document contraindication/intolerance/failure) prior to other rituximab products

Step therapy: prior trial/failure of specified conventional therapies

Step therapy also requires prior trial and failure of specified conventional therapies for some indications (e.g., RA requires ≥3 months of one csDMARD unless the member is already on biologic/targeted therapy).

• RA: failed ≥3‑month trial of one csDMARD or already established on biologic/targeted therapy
• SLE: inadequate response/intolerance to hydroxychloroquine plus a corticosteroid or immunosuppressive agent as specified

Require prior trials/failures of standard therapies for non‑oncology uses

For several non‑oncology indications, coverage requires prior trials and failure of standard therapies (e.g., glucocorticoids, azathioprine, mycophenolate, calcineurin inhibitors) unless contraindicated or intolerant.

• Document trials and failures of standard first‑line agents or provide reason for contraindication/intolerance

Document prior first‑line therapy and eGFR stability for membranous nephropathy

For idiopathic membranous nephropathy, document prior first‑line therapy history; rituximab may be considered for resistant disease following first‑line therapy and documentation of stable eGFR and prior treatments is required.

• Confirm secondary causes ruled out and provide prior first‑line therapy details (ACEi/ARB response, calcineurin inhibitor use, prior rituximab exposure)
• Document stable eGFR if considering retreatment

Guideline citations provided to inform sequencing (informational)

Guideline citations (e.g., EULAR, British Society for Rheumatology, NCCN) are provided as informational sources to support sequencing and documentation but do not by themselves create additional PA rules in this excerpt.

• Use referenced guidelines and NCCN order templates for regimen details and documentation as needed

HBV screening required; document results and monitoring plan

Document that the member was screened for hepatitis B (HBsAg and anti‑HBc) prior to initiating rituximab and include a plan for monitoring for HBV reactivation if there is evidence of prior or current infection.

• Include HBsAg and anti‑HBc testing results and monitoring plan for HBV reactivation in the medical record/PA

Confirm no live vaccines within 28 days and document avoidance plan

Confirm and document that the member has not received a live vaccine within 28 days prior to starting treatment and include a plan to avoid live vaccines while on therapy.

• Provider must attest that no live vaccines were given within 28 days prior to initiation and document plan to avoid live vaccines during treatment

Include diagnosis confirmation and objective severity measures

Required documentation varies by indication and includes diagnosis confirmation (e.g., biopsy, MRI), objective disease severity measures (e.g., PDAI for pemphigus), prior treatment history and failures, and supporting laboratory/biopsy reports.

• Provide histopathology/DIF/IIF for pemphigus, MRI reports for MS, kidney biopsy for LN, and other indication‑specific diagnostic tests
• Include prior treatment trials and evidence of failure or intolerance

Document antibody status, baseline measures, prior therapy, and monitoring plans

Providers must document diagnosis‑specific criteria such as antibody positivity (e.g., MuSK, AQP4, antisynthetase antibodies), baseline disease measures (PFTs, chest CT, proteinuria/eGFR), prior therapy trials/failures, and monitoring plans.

• Document antibody test results (MuSK, AQP4, antisynthetase) when applicable
• Provide baseline PFTs, chest CT, UPCR/proteinuria, eGFR, and steroid/immunosuppressive use as indicated

Provide baseline and follow‑up objective response measures for renewal

For renewal requests, include baseline and follow‑up objective measures of disease activity (e.g., platelet counts for ITP, ADAMTS13 activity for TTP, imaging or lab improvements) to demonstrate treatment response.

• ITP: platelet counts showing response (≥30 ×10^9/L and ≥2× baseline)
• TTP: ADAMTS13 activity improvement and reduced thrombotic risk
• MS/ILD/SLE: imaging or pulmonary function test changes as applicable

Require ≥12 months sustained remission/stability to support dose reduction at renewal

If requesting dose reduction or interval extension at renewal, documentation must show ≥12 months sustained remission and stability at the current dose/frequency for adults.

• At least 12 months sustained remission required before considering dose reduction/interval extension
• Specify proposed maintenance goal doses (e.g., RA goal 500 mg IV q6 months; MS goal 500 mg IV q12 months)

NQTL factors considered in PA design

The NQTL checklist documents factors considered (indication, safety/efficacy, misuse/abuse potential, cost) when designing and applying prior authorization to rituximab.

Include Appendix 1 ICD‑10 code with authorization/claim

Submit the applicable ICD‑10 diagnosis code from Appendix 1 with the authorization/claim to support medical necessity for rituximab.

• Ensure the claim/PA contains an Appendix 1 ICD‑10 code that matches the requested indication

Renewal may be denied for exceeded duration or unacceptable toxicity

Renewal may be denied if duration limits are exceeded or if unacceptable toxicity is present (examples include severe infusion reactions, TLS, PML, HBV reactivation, serious infections, cardiac events, renal toxicity, bowel obstruction/perforation).

• Document absence of unacceptable toxicities when requesting renewal
• Be aware listed toxicities can trigger denial

Risk of denial for insufficient demonstrated treatment response

A renewal or continuation request may be denied if there is insufficient documentation of adequate treatment response or adherence (e.g., for MS, inadequate response is defined as ≥1 relapse, ≥2 new MRI lesions, or increased disability over one year).

• Provide documentation of adherence and objective response before renewal
• For MS, document absence of the inadequate response criteria if requesting continued therapy

Dose reduction/interval extension only after ≥12 months sustained remission

Dose reduction or interval extension is allowed only on renewal after at least 12 months of sustained remission and documented stability at current dose and frequency for adults; failure to meet these renewal conditions may affect coverage.

• Do not request dose reduction/interval extension without ≥12 months documented remission and stability

Billing/coding reference risks from cited CMS LCAs

Billing and coding local coverage articles for rituximab and off‑label uses are referenced; incorrect billing/coding that does not follow those articles may affect reimbursement or trigger denials.

• See CMS LCAs (A59101, A55639, A56380) cited in references for billing/coding guidance

Risk of denial for diagnosis code mismatch (use Appendix 1 codes)

Claims lacking a supported ICD‑10 diagnosis from the covered‑diagnosis appendix (Appendix 1) may be denied; ensure the claim/authorization includes an applicable covered code.

• Verify the submitted ICD‑10 code is listed in Appendix 1 for the requested indication

Medicare claims must follow NCDs/LCDs/LCAs

Where Medicare Part B applies, claims must comply with applicable Medicare NCDs, LCDs, and LCAs; noncompliance may affect Medicare coverage determinations.

• Medicare claims must follow the Medicare Benefit Policy Manual and applicable NCD/LCD/LCA guidance

Intrathecal/intraventricular routes: interchangeability not established

For leptomeningeal disease requiring intrathecal or intraventricular administration, note that interchangeability of rituximab products for these routes has not been established; the requested product may be approved without substitution.

• Intrathecal/intraventricular administration may be required for leptomeningeal disease
• Interchangeability for intra‑CSF routes is not established—product substitution may not occur

Specify administration route (IV vs intra‑CSF) and site on PA

Administration routes include systemic IV and intra‑CSF (intrathecal/intraventricular) depending on indication; follow the regimen protocol and document the planned site/route in the PA.

• Specify systemic IV vs intra‑CSF route and planned dosing schedule when requesting PA
• Site‑of‑care (infusion center vs hospital outpatient) should be documented as clinically indicated

Use correct HCPCS/NDC for billed product; site‑of‑care may affect billing

Billing code and HCPCS guidance are provided in the policy; ensure the correct HCPCS and NDC are used for the product administered—site‑of‑care is not restricted by these chunks but may affect billing rules.

• Confirm HCPCS and NDC on claim match the administered product and vial size
• Site‑of‑care billing considerations may vary by payer/Medicare rules

Covered rituximab brands listed

Rituximab brands covered in the policy include Riabni, Rituxan, Ruxience, and Truxima; coverage applies across the listed products subject to step/PA rules.

• Covered brands: Riabni®, Rituxan®, Ruxience®, Truxima®

Document contraindication/intolerance/failure to all three named biosimilars before other products

Providers must document that the member has a contraindication, intolerance, or failure to Riabni, Ruxience, AND Truxima prior to consideration of another rituximab product; this requirement is explicit in the policy.

• Explicit three‑biosimilar trial/failure requirement before other rituximab products are considered

HCPCS Q‑codes and NDCs for biosimilars and reference product

HCPCS Q‑codes Q5115, Q5119, Q5123 are listed for biosimilars alongside J9312 for reference rituximab; NDC listings for each product and vial size are provided and should be used for product identification in PA and claims.

• HCPCS: J9312 (reference), Q5115 (Truxima), Q5119 (Ruxience), Q5123 (Riabni)
• NDC examples provided for 100 mg and 500 mg vials of each product

Use listed biosimilar HCPCS Q‑codes and NDCs for claims

Additional HCPCS Q‑codes and NDC entries for the biosimilars are listed in the policy Appendix; use these for accurate product identification on authorizations and claims.

Biosimilar comparison studies cited; no explicit substitution rule in excerpt

The policy cites analytical and clinical comparisons of biosimilars to the rituximab reference product but does not state an explicit payer substitution or preference rule in this excerpt.

• Biosimilar comparability studies are referenced; no explicit automatic substitution policy noted here

References only (no PA rules)

This references list segment contains citations and does not impose provider actions beyond using the references to support documentation where appropriate.

Reference‑only section

Placeholder reference-only callout; no provider actions specified in this excerpt.