Oncology & Hematology Coding Alert

Keep documentation for patient selection and any prior treatment.

Have you been coding accurately for venetoclax? On April 11, 2016, the FDA approved venetoclax (Venclexta; Janssen) tablets for the treatment of patients of chronic lymphocytic leukemia (CLL) with depletion of 17p chromosome.

When to use venetoclax: Your physician will prescribe venetoclax when:

1. The detection of chromosome 17p deletion is established by an FDA-approved test (Vysis CLL FISH Probe Kit).
2. Patient has received at least one previous therapy.

You can access the prescribing information on: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208573s000lbl.pdf

No dedicated code for venetoclax: When your physician prescribes venetoclax, you should submit code J8499 (Prescription drug, oral, non-chemotherapeutic, not otherwise specified), as there isn’t a specific code for this new non chemotherapeutic oral drug. The code J8499 code applies to a nonchemotherapeutic prescription drug administered orally, not described by another code. According to the 2016 Coder’s Desk Reference, J8499 is used “to represent an oral prescription drug that is not a form of chemotherapy and is not represented by any other Level I or Level II HCPCS code.”

“Once this code is assigned for a medication, a more specific code can be used to report it. Be on the lookout for HCPCS code updates from the Centers of Medicare and Medicaid Services (CMS),” says Kelly C. Loya, CPC-I, CHC, CPhT, CRMA, Managing Director of Pinnacle Enterprise Risk Consulting Services (“PERCS”), a division of Pinnacle Healthcare Consulting.

Payer policies: Make sure you have listed all essentials on the claim. “As with any unlisted code, payers will want the name, strength National Drug Code and number of units listed on the claim to understand and reimburse the provider for the specific substance supplied to the patient,” Loya says. “Check with your payer to determine whether this medication may be dispensed by the physician office. It appears from the packaging label, this would likely be through their pharmacy benefit.”

Dosage of venetoclax: Your physician will prescribe venetoclax once daily until the disease progresses or unacceptable toxicity is observed. Venetoclax is available in strengths of 10 mg, 50 mg, and 100 mg. Your physician will develop a plan for daily dosing for the patient.

Venetoclax is a non-chemotherapeutic agent: Venetoclax is a selective small-molecule inhibitor of BCL-2. An anti-apoptotic protein, BCL-2 is over expressed in the tumor cells in CLL cells where it mediates tumor cell survival and has been associated with resistance to chemotherapeutics. Venetoclax directly binds to BCL-2 and helps to restore the process of apoptosis.

Venetoclax offers a new targeted option in CLL: Based on the data for overall response rate, the FDA granted approval for venetoclax under the accelerated approval process. Venetoclax monotherapy has been proven to be active and well tolerated in a phase 2, single-arm, multicentre study for relapsed or refractory del(17p) CLL. You can read details of the clinical study on: http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(16)30019-5/abstract. However, continued approval of venetoclax for relapsed refractory CLL may rest upon verification of the established clinical benefit in a confirmatory trial.

“These patients now have a new, targeted therapy that inhibits a protein involved in keeping tumor cells alive,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “For certain patients with CLL who have not had favorable outcomes with other therapies, Venclexta may provide a new option for their specific condition.”

You can read the FDA press release on: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm495253.htm.