Effective with date of service Jan 5, 2021, the Medicaid and NC Health Choice programs cover rituximab-arrx injection, for intravenous use (Riabni™) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J3590 - Unclassified biologics.
Strength/Package Sizes: Injection: 100 mg/10 mL (10 mg/mL) and 500 mg/50 mL (10 mg/mL) solution in single-dose vials
Indicated for the treatment of:
- Adult patients with non-Hodgkin’s Lymphoma (NHL).
- Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.
- Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.
- Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
- Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or other anthracycline-based chemotherapy regimens.
- Adult patients with Chronic Lymphocytic Leukemia (CLL).
- Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC).
- Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids
Recommended Dose (see full prescribing information for further detail):
- The dose for NHL is 375 mg/m2 according to the following schedules:
- Relapsed or Refractory, Low-Grade or Follicular, CD20-Positive, B-Cell NHL: Administer once weekly for 4 or 8 doses.
- Retreatment for Relapsed or Refractory, Low-Grade or Follicular, CD20-Positive, B-Cell NHL: Administer once weekly for 4 doses.
- Previously Untreated, Follicular, CD20-Positive, B-Cell NHL: Administer on Day 1 of each cycle of chemotherapy, for up to 8 doses. In patients with complete or partial response, initiate Riabni™ maintenance eight weeks following completion of a rituximab product in combination with chemotherapy. Administer Riabni™ as a single-agent every 8 weeks for 12 doses.
- Non-progressing, Low-Grade, CD20-Positive, B-Cell NHL, after first-line CVP chemotherapy: Following completion of 6-8 cycles of CVP chemotherapy, administer once weekly for 4 doses at 6-month intervals to a maximum of 16 doses.
- Diffuse Large B-Cell NHL: Administer on Day 1 of each cycle of chemotherapy for up to 8 infusions.
- The dose for CLL is 375 mg/m2 in the first cycle and 500 mg/m2 in cycles 2-6, in combination with FC, administered every 28 days.
- The dose as a component of Zevalin (ibritumomab tiuxetan) Therapeutic Regimen is 250 mg/m2.
- The induction dose for adult patients with active GPA and MPA in combination with glucocorticoids is 375 mg/m2 once weekly for 4 weeks. The follow up dose for adult patients with GPA and MPA who have achieved disease control with induction treatment, in combination with glucocorticoids is two 500 mg intravenous infusions separated by two weeks, followed by a 500 mg intravenous infusion every 6 months thereafter based on clinical evaluation.
For Medicaid and NC Health Choice Billing
- The ICD-10-CM diagnosis codes required for billing are:
- NHL: C82.00 - Follicular lymphoma grade I, unspecified site; C82.01 - Follicular lymphoma grade I, lymph nodes of head, face, and neck; C82.02 - Follicular lymphoma grade I, intrathoracic lymph nodes; C82.03 - Follicular lymphoma grade I, intra-abdominal lymph nodes; C82.04 - Follicular lymphoma grade I, lymph nodes of axilla and upper limb; C82.05 - Follicular lymphoma grade I, lymph nodes of inguinal region and lower limb; C82.06 - Follicular lymphoma grade I, intrapelvic lymph nodes; C82.07 - Follicular lymphoma grade I, spleen; C82.08 - Follicular lymphoma grade I, lymph nodes of multiple sites; C82.09 - Follicular lymphoma grade I, extranodal and solid organ sites; C82.10 - Follicular lymphoma grade II, unspecified site; C82.11 - Follicular lymphoma grade II, lymph nodes of head, face, and neck; C82.12 - Follicular lymphoma grade II, intrathoracic lymph nodes; C82.13 - Follicular lymphoma grade II, intra-abdominal lymph nodes; C82.14 - Follicular lymphoma grade II, lymph nodes of axilla and upper limb; C82.15 - Follicular lymphoma grade II, lymph nodes of inguinal region and lower limb; C82.16 - Follicular lymphoma grade II, intrapelvic lymph nodes; C82.17 - Follicular lymphoma grade II, spleen; C82.18 - Follicular lymphoma grade II, lymph nodes of multiple sites; C82.19 - Follicular lymphoma grade II, extranodal and solid organ sites; C82.20 - Follicular lymphoma grade III, unspecified, unspecified site; C82.21 - Follicular lymphoma grade III, unspecified, lymph nodes of head, face, and neck; C82.22 - Follicular lymphoma grade III, unspecified, intrathoracic lymph nodes; C82.23 - Follicular lymphoma grade III, unspecified, intra-abdominal lymph nodes; C82.24 - Follicular lymphoma grade III, unspecified, lymph nodes of axilla and upper limb; C82.25 - Follicular lymphoma grade III, unspecified, lymph nodes of inguinal region and lower limb; C82.26 - Follicular lymphoma grade III, unspecified, intrapelvic lymph nodes; C82.27 - Follicular lymphoma grade III, unspecified, spleen; C82.28 - Follicular lymphoma grade III, unspecified, lymph nodes of multiple sites; C82.29 - Follicular lymphoma grade III, unspecified, extranodal and solid organ sites; C82.30 - Follicular lymphoma grade IIIa, unspecified site; C82.31 - Follicular lymphoma grade IIIa, lymph nodes of head, face, and neck; C82.32 - Follicular lymphoma grade IIIa, intrathoracic lymph nodes; C82.33 - Follicular lymphoma grade IIIa, intra-abdominal lymph nodes; C82.34 - Follicular lymphoma grade IIIa, lymph nodes of axilla and upper limb; C82.35 - Follicular lymphoma grade IIIa, lymph nodes of inguinal region and lower limb; C82.36 - Follicular lymphoma grade IIIa, intrapelvic lymph nodes; C82.37 - Follicular lymphoma grade IIIa, spleen; C82.38 - Follicular lymphoma grade IIIa, lymph nodes of multiple sites; C82.39 - Follicular lymphoma grade IIIa, extranodal and soli organ sites; C82.40 - Follicular lymphoma grade IIIb, unspecified site; C82.41 - Follicular lymphoma grade IIIb, lymph nodes of head, face, and neck; C82.42 - Follicular lymphoma grade IIIb, intrathoracic lymph nodes; C82.43 - Follicular lymphoma grade IIIb, intra-abdominal lymph nodes; C82.44 - Follicular lymphoma grade IIIb, lymph nodes of axilla and upper limb; C82.45 - Follicular lymphoma grade IIIb, lymph nodes of inguinal region and lower limb; C82.46 - Follicular lymphoma grade IIIb, intrapelvic lymph nodes; C82.47 - Follicular lymphoma grade IIIb, spleen; C82.48 - Follicular lymphoma grade IIIb, lymph nodes of multiple sites; C82.49 - Follicular lymphoma grade IIIb, extranodal and solid organ sites; C82.50 - Diffuse follicle center lymphoma, unspecified site; C82.51 - Diffuse follicle center lymphoma, lymph nodes of head, face, and neck; C82.52 - Diffuse follicle center lymphoma, intrathoracic lymph nodes; C82.53 - Diffuse follicle center lymphoma, intra-abdominal lymph nodes; C82.54 - Diffuse follicle center lymphoma, lymph nodes of axilla and upper limb; C82.55 - Diffuse follicle center lymphoma, lymph nodes of inguinal region and lower limb; C82.56 - Diffuse follicle center lymphoma, intrapelvic lymph nodes; C82.57 - Diffuse follicle center lymphoma, spleen; C82.58 - Diffuse follicle center lymphoma, lymph nodes of multiple sites; C82.59 - Diffuse follicle center lymphoma, extranodal and solid organ sites; C82.60 - Cutaneous follicle center lymphoma, unspecified site; C82.61 - Cutaneous follicle center lymphoma, lymph nodes of head, face, and neck; C82.62 - Cutaneous follicle center lymphoma, intrathoracic lymph nodes; C82.63 - Cutaneous follicle center lymphoma, intra-abdominal lymph nodes; C82.64 - Cutaneous follicle center lymphoma, lymph nodes of axilla and upper limb; C82.65 - Cutaneous follicle center lymphoma, lymph nodes of inguinal region and lower limb; C82.66 - Cutaneous follicle center lymphoma, intrapelvic lymph nodes; C82.67 - Cutaneous follicle center lymphoma, spleen; C82.68 - Cutaneous follicle center lymphoma, lymph nodes of multiple sites; C82.69 - Cutaneous follicle center lymphoma, extranodal and solid organ sites; C82.80 - Other types of follicular lymphoma, unspecified site; C82.81 - Other types of follicular lymphoma, lymph nodes of head, face, and neck; C82.82 - Other types of follicular lymphoma, intrathoracic lymph nodes; C82.83 - Other types of follicular lymphoma, intra-abdominal lymph nodes; C82.84 - Other types of follicular lymphoma, lymph nodes of axilla and upper limb; C82.85 - Other types of follicular lymphoma, lymph nodes of inguinal region and lower limb; C82.86 - Other types of follicular lymphoma, intrapelvic lymph nodes; C82.87 - Other types of follicular lymphoma, spleen; C82.88 - Other types of follicular lymphoma, lymph nodes of multiple sites; C82.89 - Other types of follicular lymphoma, extranodal and solid organ sites; C82.90 - Follicular lymphoma, unspecified, unspecified site; C82.91 - Follicular lymphoma, unspecified, lymph nodes of head, face, and neck; C82.92 - Follicular lymphoma, unspecified, intrathoracic lymph nodes; C82.93 - Follicular lymphoma, unspecified, intra-abdominal lymph nodes; C82.94 - Follicular lymphoma, unspecified, lymph nodes of axilla and upper limb; C82.95 - Follicular lymphoma, unspecified, lymph nodes of inguinal region and lower limb; C82.96 - Follicular lymphoma, unspecified, intrapelvic lymph nodes; C82.97 - Follicular lymphoma, unspecified, spleen; C82.98 - Follicular lymphoma, unspecified, lymph nodes of multiple sites; C82.99 - Follicular lymphoma, unspecified, extranodal and solid organ sites; C83.00 - Small cell B-cell lymphoma, unspecified site; C83.01 - Small cell B-cell lymphoma, lymph nodes of head, face, and neck; C83.02 - Small cell B-cell lymphoma, intrathoracic lymph nodes; C83.03 - Small cell B-cell lymphoma, intra-abdominal lymph nodes; C83.04 - Small cell B-cell lymphoma, lymph nodes of axilla and upper limb; C83.05 - Small cell B-cell lymphoma, lymph nodes of inguinal region and lower limb; C83.06 - Small cell B-cell lymphoma, intrapelvic lymph nodes; C83.07 - Small cell B-cell lymphoma, spleen; C83.08 - Small cell B-cell lymphoma, lymph nodes of multiple sites; C83.09 - Small cell B-cell lymphoma, extranodal and solid organ sites; C83.30 - Diffuse large B-cell lymphoma, unspecified site; C83.31 - Diffuse large B-cell lymphoma, lymph nodes of head, face, and neck; C83.32 - Diffuse large B-cell lymphoma, intrathoracic lymph nodes; C83.33 - Diffuse large B-cell lymphoma, intra-abdominal lymph nodes; C83.34 - Diffuse large B-cell lymphoma, lymph nodes of axilla and upper limb; C83.35 - Diffuse large B-cell lymphoma, lymph nodes of inguinal region and lower limb; C83.36 - Diffuse large B-cell lymphoma, intrapelvic lymph nodes; C83.37 - Diffuse large B-cell lymphoma, spleen; C83.38 - Diffuse large B-cell lymphoma, lymph nodes of multiple sites; C83.39 - Diffuse large B-cell lymphoma, extranodal and solid organ sites; C83.80 - Other non-follicular lymphoma, unspecified site; C83.81 - Other non-follicular lymphoma, lymph nodes of head, face, and neck; C83.82 - Other non-follicular lymphoma, intrathoracic lymph nodes; C83.83 - Other non-follicular lymphoma, intra-abdominal lymph nodes; C83.84 - Other non-follicular lymphoma, lymph nodes of axilla and upper limb; C83.85 - Other non-follicular lymphoma, lymph nodes of inguinal region and lower limb; C83.86 - Other non-follicular lymphoma, intrapelvic lymph nodes; C83.87 - Other non-follicular lymphoma, spleen; C83.88 - Other non-follicular lymphoma, lymph nodes of multiple sites; C83.89 - Other non-follicular lymphoma, extranodal and solid organ sites; C85.10 - Unspecified B-cell lymphoma, unspecified site; C85.11 - Unspecified B-cell lymphoma, lymph nodes of head, face, and neck; C85.12 - Unspecified B-cell lymphoma, intrathoracic lymph nodes; C85.13 - Unspecified B-cell lymphoma, intra-abdominal lymph nodes; C85.14 - Unspecified B-cell lymphoma, lymph nodes of axilla and upper limb; C85.15 - Unspecified B-cell lymphoma, lymph nodes of inguinal region and lower limb; C85.16 - Unspecified B-cell lymphoma, intrapelvic lymph nodes; C85.17 - Unspecified B-cell lymphoma, spleen; C85.18 - Unspecified B-cell lymphoma, lymph nodes of multiple sites; C85.19 - Unspecified B-cell lymphoma, extranodal and solid organ sites; C85.80 - Other specified types of non-Hodgkin lymphoma, unspecified site; C85.81 - Other specified types of non-Hodgkin lymphoma, lymph nodes of head, face, and neck; C85.82 - Other specified types of non-Hodgkin lymphoma, intrathoracic lymph nodes; C85.83 - Other specified types of non-Hodgkin lymphoma, intra-abdominal lymph nodes; C85.84 - Other specified types of non-Hodgkin lymphoma, lymph nodes of axilla and upper limb; C85.85 - Other specified types of non-Hodgkin lymphoma, lymph nodes of inguinal region and lower limb; C85.86 - Other specified types of non-Hodgkin lymphoma, intrapelvic lymph nodes; C85.87 - Other specified types of non-Hodgkin lymphoma, spleen; C85.88 - Other specified types of non-Hodgkin lymphoma, lymph nodes of multiple sites; C85.89 - Other specified types of non-Hodgkin lymphoma, extranodal and solid organ sites; C85.90 - Non-Hodgkin lymphoma, unspecified, unspecified site; C85.91 - Non-Hodgkin lymphoma, unspecified, lymph nodes of head, face, and neck; C85.92 - Non-Hodgkin lymphoma, unspecified, intrathoracic lymph nodes; C85.93 - Non-Hodgkin lymphoma, unspecified, intra-abdominal lymph nodes; C85.94 - Non-Hodgkin lymphoma, unspecified, lymph nodes of axilla and upper limb; C85.95 - Non-Hodgkin lymphoma, unspecified, lymph nodes of inguinal region and lower limb; C85.96 - Non-Hodgkin lymphoma, unspecified, intrapelvic lymph nodes; C85.97 - Non-Hodgkin lymphoma, unspecified, spleen; C85.98 - Non-Hodgkin lymphoma, unspecified, lymph nodes of multiple sites; C85.99 - Non-Hodgkin lymphoma, unspecified, extranodal and solid organ site;
- CLL:
- C91.10 - Chronic lymphocytic leukemia of B-cell type not having achieved remission;
- C91.12 - Chronic lymphocytic leukemia of B-cell type in relapse;
- GPA (Wegener’s Granulomatosis):
- M31.30 - Wegener's granulomatosis without renal involvement,
- M31.31 - Wegener's granulomatosis with renal involvement;
- MPA: M31.7 - Microscopic polyangiitis
- Providers must bill with HCPCS code: J3590 - Unclassified biologics
- One Medicaid and NC Health Choice unit of coverage is: 10 mg
- The maximum reimbursement rate per unit is: $77.41
- Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs are:55513-0224-01, 55513-0326-01
- 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 PADP, refer to the PADP Clinical Coverage Policy 1B, Attachment A, H.7 on Medicaid's website
- Providers shall bill their usual and customary charge for non-340B drugs
- PADP reimburses for drugs billed for Medicaid and Health Choice beneficiaries by 340B 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 340B purchasing agreement by appending the “UD” modifier on the drug detail.
- The fee schedule for the PADP is available on Medicaid's PADP web page
Contact
NCTracks Contact Center: 800-688-6696