Reimbursement

RITUXAN HYCELA Sample Coding

This coding information may assist you as you complete the payer forms for RITUXAN HYCELA. These tables are provided for informational purposes only. Please visit CMS.gov or other payers’ websites to obtain additional guidance on their processes related to billing and coding for single-use vials and wastage.

You can generate a PDF of these coding tables by selecting either the "Download All" or the "Download Section" button:

  • "Download All" lets you download or print a coding table for all indications
  • "Download Section" lets you download or print a coding table for a specific indication
TYPE CODE DESCRIPTION
Diagnosis: ICD-10-CM C82.90—C82.99
Follicular lymphoma, unspecified
C82.00—C82.09 Follicular lymphoma grade I
C82.10—C82.19
Follicular lymphoma grade II
C82.20—C82.29
Follicular lymphoma grade III, unspecified
C82.30—C82.39
Follicular lymphoma grade IIIa
C82.40—C82.49
Follicular lymphoma grade IIIb
C82.50—C82.59
Diffuse follicle center lymphoma
C82.60—C82.69
Cutaneous follicle center lymphoma
C82.80—C82.89
Other types of follicular lymphoma
Drug: HCPCS J3590 Unclassified biologics
J3490 Unclassified drugs
J9999 Not otherwise classified, antineoplastic drugs
Hospital Outpatient HCPCS* C9467
Injection, rituximab and hyaluronidase, 10 mg

Drug: NDC
Note: Payer requirements regarding use of a 10-digit or 11-digit NDC may vary. Both formats are listed here for your reference.

10-digit 11-digit  
50242-108-01 50242-0108-01 1,400 mg rituximab and 23,400 Units hyaluronidase human per 11.7 mL
(120 mg/2,000 Units per mL) solution in a single-dose vial
50242-109-01 50242-0109-01 1,600 mg rituximab and 26,800 Units hyaluronidase human per 13.4 mL
(120 mg/2,000 Units per mL) solution in a single-dose vial
Administration procedures: CPT 96401
Chemotherapy administration, subcutaneous or intramuscular; non-hormonal anti-neoplastic

CPT=Current Procedural Terminology.
HCPCS=Healthcare Common Procedure Coding System.
ICD-10-CM=International Classification of Diseases, 10th Revision, Clinical Modification.
NDC=National Drug Code. 

*The C-code is used primarily in the Medicare hospital outpatient setting. However, some payers accept C9467 instead of unclassified J- or C-codes when billing for RITUXAN HYCELA. Please check with your payers to verify codes and special billing requirements.

TYPE CODE DESCRIPTION
Diagnosis: ICD-10-CM C83.30—C83.39
Diffuse large B-cell lymphoma
Drug: HCPCS J3590 Unclassified biologics
J3490 Unclassified drugs
J9999 Not otherwise classified, antineoplastic drugs
Hospital Outpatient HCPCS* C9467
Injection, rituximab and hyaluronidase, 10 mg
Drug: NDC
Note: Payer requirements regarding use of a 10-digit or 11-digit NDC may vary. Both formats are listed here for your reference.
10-digit 11-digit  
50242-108-01
50242-0108-01
1,400 mg rituximab and 23,400 Units hyaluronidase human per 11.7 mL
(120 mg/2,000 Units per mL) solution in a single-dose vial
50242-109-01
50242-0109-01
1,600 mg rituximab and 26,800 Units hyaluronidase human per 13.4 mL
(120 mg/2,000 Units per mL) solution in a single-dose vial
Administration procedures: CPT 96401
Chemotherapy administration, subcutaneous or intramuscular; non-hormonal anti-neoplastic

CPT = Current Procedural Terminology.
HCPCS = Healthcare Common Procedure Coding System.
ICD-10-CM = International Classification of Diseases, 10th Revision, Clinical Modification.
NDC = National Drug Code.

*The C-code is used primarily in the Medicare hospital outpatient setting. However, some payers accept C9467 instead of unclassified J- or C-codes when billing for RITUXAN HYCELA. Please check with your payers to verify codes and special billing requirements.

TYPE CODE DESCRIPTION
Diagnosis: ICD-10-CM C91.10 Chronic lymphocytic leukemia of B-cell type not having achieved remission
C91.12 Chronic lymphocytic leukemia of B-cell type in relapse
Drug: HCPCS J3590 Unclassified biologics
J3490 Unclassified drugs
J9999 Not otherwise classified, antineoplastic drugs
Hospital Outpatient HCPCS* C9467
Injection, rituximab and hyaluronidase, 10 mg
Drug: NDC
Note: Payer requirements regarding use of a 10-digit or 11-digit NDC may vary. Both formats are listed here for your reference.
10-digit 11-digit  
50242-108-01
50242-0108-01
1,400 mg rituximab and 23,400 Units hyaluronidase human per 11.7 mL
(120 mg/2,000 Units per mL) solution in a single-dose vial
50242-109-01
50242-0109-01
1,600 mg rituximab and 26,800 Units hyaluronidase human per 13.4 mL
(120 mg/2,000 Units per mL) solution in a single dose vial
Administration procedures: CPT 96401
Chemotherapy administration, subcutaneous or intramuscular; non-hormonal anti-neoplastic

CPT=Current Procedural Terminology.
HCPCS=Healthcare Common Procedure Coding System.
ICD-10-CM=International Classification of Diseases, 10th Revision, Clinical Modification.
NDC=National Drug Code. 

*The C-code is used primarily in the Medicare hospital outpatient setting. However, some payers accept C9467 instead of unclassified J- or C-codes when billing for RITUXAN HYCELA. Please check with your payers to verify codes and special billing requirements.

These codes are not all-inclusive; appropriate codes can vary by patient, setting of care and payer. Correct coding is the responsibility of the provider submitting the claim for the item or service. Please check with the payer to verify codes and special billing requirements. Genentech and Biogen do not make any representation or guarantee concerning reimbursement or coverage for any service or item.

Many payers will not accept unspecified codes. If you use an unspecified code, please check with your payer.

Appeals

If your patient’s health insurance plan has issued a denial, your BioOncology Field Reimbursement Manager (BFRM) or Genentech BioOncology® Access Solutions for RITUXAN HYCELA Specialist can provide resources as you prepare an appeal submission, as per your patient’s plan requirements.

If a plan issues a denial:

  1. The denial should be reviewed, along with the health insurance plan’s guidelines to determine what to include in your patient’s appeal submission.
  2. Your BFRM or Genentech BioOncology Access Solutions Specialist has local payer coverage expertise and can help you determine specific requirements for your patient.

A sample appeal letter and additional considerations are available in Forms and Documents.

Appeals cannot be completed or submitted by Genentech BioOncology Access Solutions on your behalf.

Understanding Claims Submission for Office-administered Products Using a Miscellaneous J-code Video

Play Video

PAN=Patient Authorization and Notice of Request for Transmission of Health Information to Genentech Access Solutions and Genentech® Access to Care Foundation.

SMN=Statement of Medical Necessity.

Important Safety Information & Indication

Indication

RITUXAN HYCELA® (rituximab/hyaluronidase human) is indicated for the treatment of adult patients with:

  • Relapsed or refractory, follicular lymphoma (FL) as a single agent.
  • Previously untreated follicular lymphoma in combination with first-line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy.
  • Non-progressing (including stable disease) follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
  • Previously untreated diffuse large B-cell lymphoma (DLBCL) in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline based-chemotherapy regimens.
  • Previously untreated and previously treated chronic lymphocytic leukemia (CLL) in combination with fludarabine and cyclophosphamide (FC).

Initiate treatment with RITUXAN HYCELA only after patients have received at least one full dose of RITUXAN®

RITUXAN HYCELA is not indicated for the treatment of non-malignant conditions.

Important Safety Information

BOXED WARNINGS: SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

  • Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab-containing products, including RITUXAN HYCELA.
  • Hepatitis B Virus (HBV) Reactivation: HBV reactivation can occur in patients treated with rituximab-containing products, including RITUXAN HYCELA, in some cases resulting in fulminant hepatitis, hepatic failure, and Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with RITUXAN HYCELA. Discontinue RITUXAN HYCELA and concomitant medications in the event of HBV reactivation.
  • Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab-containing products, including RITUXAN HYCELA.

Warnings and Precautions

Hypersensitivity and Other Administration Reactions

  • Local cutaneous reactions may occur more than 24 hours after administration. Interrupt injection if severe reaction develops. Premedicate before injection

Tumor Lysis Syndrome (TLS)

  • TLS can occur within 12-24 hours after administration of a rituximab-containing product, including RITUXAN HYCELA. Administer aggressive intravenous hydration, anti-hyperuricemic agents, monitor renal function

Infections

  • Severe, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of therapy with rituximab-containing products, including RITUXAN HYCELA. Withhold and institute appropriate anti-infective therapy.

Cardiovascular Adverse Reactions

  • Discontinue in case of serious or life-threatening events

Renal Toxicity

  • Severe, including fatal, renal toxicity can occur after administration of rituximab-containing products, including RITUXAN HYCELA. Discontinue in patients with rising serum creatinine or oliguria

Bowel Obstruction and Perforation

  • Abdominal pain, bowel obstruction, and perforation, in some cases leading to death, can occur in patients receiving rituximab-containing products, including RITUXAN HYCELA, in combination with chemotherapy. Consider and evaluate for abdominal pain, vomiting, or related symptoms

Immunization

  • Live virus vaccinations prior to or during treatment not recommended

Embryo-Fetal Toxicity

  • Can cause neonatal harm. Advise of potential risk to neonates and use of effective contraception.

Adverse Reactions

  • The most common adverse reactions (≥ 20%) of RITUXAN HYCELA observed in patients with FL in SABRINA were: infections, neutropenia, nausea, constipation, cough, and fatigue.
  • The most common adverse reactions (≥ 20%) of RITUXAN HYCELA observed in patients with DLBCL in MabEASE were: infections, neutropenia, alopecia, nausea, and anemia.
  • The most common adverse reactions (≥ 20%) of RITUXAN HYCELA observed in patients with CLL in part 2 of SAWYER were: infections, neutropenia, nausea, thrombocytopenia, pyrexia, vomiting, and injection site erythema.

Please see the full Prescribing Information, including BOXED WARNINGS and Medication Guide, for additional Important Safety Information.

Attention Healthcare Provider: Provide Medication Guide to patient prior to RITUXAN HYCELA treatment.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.