Reimbursement

POLIVY Sample Coding

This coding information may assist you as you complete the payer forms for POLIVY. 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 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
Drug: HCPCS J3590 Unclassified biologics
J3490 Unclassified drugs
J9999 Not otherwise classified, antineoplastic drugs
Drug: NDC
Note: Payer requirements regarding use of 10-digit or 11-digit NDC may vary. Both formats are listed here for your reference.
10-digit 11-digit 140 mg/20 mL single-dose vial
50242-105-01 50242-0105-01
Administration procedures: CPT 96413 Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug
96415 Chemotherapy administration, intravenous infusion technique; each additional hour (List separately in addition to code for primary procedure)

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. 

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 does 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 POLIVY Access Solutions 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 POLIVY 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 for appeals are available in Forms and Documents.

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

Important Safety Information & Indication

Indication Statement

POLIVY in combination with bendamustine and a rituximab product is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least 2 prior therapies.

Accelerated approval was granted for this indication based on complete response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Warnings and Precautions
Peripheral Neuropathy: Monitor patients for peripheral neuropathy and modify or discontinue dose accordingly.
Infusion-Related Reactions: Premedicate with an antihistamine and an antipyretic. Monitor patients closely during infusions. Interrupt or discontinue infusion if reactions occur.
Myelosuppression: Monitor complete blood counts. Manage using dose delays or reductions and growth factor support. Monitor for signs of infection.
Serious and Opportunistic Infections: Closely monitor patients for signs of bacterial, fungal, or viral infections.
Progressive Multifocal Leukoencephalopathy (PML): Monitor patients for new or worsening neurological, cognitive, or behavioral changes suggestive of PML.
Tumor Lysis Syndrome: Closely monitor patients with high tumor burden or rapidly proliferating tumors.
Hepatotoxicity: Monitor liver enzymes and bilirubin.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 3 months after the last dose.

The Most Common Adverse Reactions
The most common adverse reactions (≥20%) included neutropenia, thrombocytopenia, anemia, peripheral neuropathy, fatigue, diarrhea, nausea, pyrexia, decreased appetite, abdominal pain, and pneumonia.

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.

Please see the full Prescribing Information for additional Important Safety Information.