Rituximab (Rituxan) HCPCS code J9310 Rituximab, 100 mg, injection: Billing Guidelines

Effective with the date of service of April 30, 2018, the North Carolina Medicaid and N.C. Health Choice (NCHC) programs will be terminating Clinical Policy 1B-2, Rituximab (Rituxan), within the Physician Drug Program (PDP). Requirements, indications, and all other information of the policy are indicated below. From the perspective of the providers, all things associated with the process of submitting claims regarding the Botulinum agents will remain unchanged.

See prescribing information for details.

Below is information regarding Rituxan.

Medicaid and NCHC cover Rituximab for the following FDA-approved indications:

1. Non-Hodgkin’s Lymphoma (NHL)

1. Rituximab is covered for the treatment of patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-Cell non-Hodgkin’s lymphoma as a single agent.
2. Rituximab is covered for the treatment of patients with previously untreated follicular, CD20-positive, B-Cell NHL in combination with first-line chemotherapy and – in patients achieving a complete or partial response to rituximab in combination with chemotherapy – as a single-agent maintenance therapy.
3. Rituximab is covered for the treatment of patients with previously untreated diffuse large B-Cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicine, vincristine, and prednisone (CHOP) or other anthracycline-based chemotherapy regimens.
4. Rituximab is covered for the treatment of patients with non-progressing (including stable disease) low grade CD20-positive, B-Cell NHL as a single agent after first-line cyclophosphamide, vincristine and prednisolone (CVP) chemotherapy.Rheumatoid Arthritis (RA)

2. Rheumatoid Arthritis (RA)
   Rituximab, in combination with methotrexate, is covered to reduce signs and symptoms in adult patients with moderately to severely active RA who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.
3. Chronic Lymphocytic Leukemia (CLL)
   Rituximab is covered, in combination with fludarabine and cyclophosphamide (FC), for the treatment of patients with previously untreated or previously treated CD20-positive CLL.
4. Wegener’s Granulomatosis
   Rituximab, in combination with glucocorticoids, is covered for the treatment of adult patients with Wegener’s granulomatosis (WG).
5. Microscopic Polyangiitis
   Rituximab, in combination with glucocorticoids, is covered for the treatment of adult patients with microscopic polyangiitis (MPA).

Medicaid and NCHC cover Rituximab for the following off-label indications:

1. Low-Grade Non-Hodgkin’s Lymphoma
   Rituximab is covered as initial treatment of low grade CD20-positive NHL.
2. Waldenstrom’s Macroglobulinemia
3. Systemic Lupus Erythematosis (SLE) and/or Lupus Nephritis
   Rituximab is covered for those patients with SLE or lupus nephritis refractory to usual therapy.
4. Immune or Idiopathic Thrombocytopenic Purpura
   Rituximab is covered for those patients with immune or idiopathic thrombocytopenic purpura (ITP) who have failed conventional treatment (e.g., corticosteroid treatment).
5. Autoimmune Hemolytic Anemia
   Rituximab is covered for those patients with an autoimmune hemolytic anemia condition that is refractory to conventional treatment (e.g., corticosteroid treatment).
6. Thrombotic Thrombocytopenic Purpura
   Rituximab is covered for those patients with persistent inhibitors and who have failed to achieve control with conventional plasma exchange and corticosteroid therapy.
7. Juvenile Chronic Polyarthritis

For Medicaid and NCHC Billing

• The ICD-10-CM diagnosis code required for billing are:

• Providers must bill with HCPCS code J9310 - Rituximab (Rituxin) injection.
• One Medicaid unit of coverage is100 mg. NCHC bills according to Medicaid units.
• The maximum reimbursement rate per unit is $496.85.
• Providers must bill 11-digit National Drug Codes (NDCs) and appropriate NDC units. The NDCs are 50242005121 and 50242005306.
• The NDC units should be reported as “UN1.”
• For additional information, refer to the January 2012, Special Bulletin, National Drug Code Implementation Update.
• For additional information regarding NDC claim requirements related to the PDP, refer to the PDP Clinical Coverage Policy No. 1B<, Physicians Drug Program, Attachment A, H.7 on Medicaid’s website.
• Providers shall bill their usual and customary charge for non-340-B drugs.
• PDP reimburses for drugs billed for Medicaid and NCHC beneficiaries by 340-B participating providers who have registered with the Office of Pharmacy Affairs (OPA). Providers billing for 340B drugs shall bill the cost that is reflective of their acquisition cost. Providers shall indicate that a drug was purchased under a 340-B purchasing agreement by appending the “UD” modifier on the drug detail.
• The fee schedule for the PDP is available on the North Carolina Medicaid PDP web page.

CSRA 1-800-688-6696