Oncology & Hematology Coding Alert

You can only claim for combination therapy with daratumumab.

Breaking news: daratumumab has received U.S. Food and Drug Administration (FDA) approval. On Nov 21, 2016, the FDA approved daratumumab for combination therapy in multiple myeloma. This means you need to have your codes ready.

More info: For more on FDA approval of daratumumab, you can go to URL: www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm530249.htm

Establish Medical Necessity for Your Claims

Before you can bill for daratumumab, you will need to ensure you have complete documentation to establish the medical necessity for this drug.

When is daratumumab covered? You will be reimbursed for daratumumab only if your provider selects to administer daratumumab to a patient who has relapsed or refractory multiple myeloma. Before you bill for daratumumab, find out which of the following three criteria help establish the necessity for daratumumab.

A. Daratumumab used as a single agent for individuals with relapsed or refractory disease following therapy who have received at least three two prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent;  or

B. Daratumumab used as combination therapy for individuals with relapsed or refractory disease following therapy with at least one prior line of therapy including a PI or an immunomodulatory agent when used with: bortezomib and dexamethasone; or lenalidomide and dexamethasone; and

C. The patient has not received treatment with daratumumab or another anti-CD38 agent.

Use these dug names as guide to scan the clinical report: To be able to identify the above three criteria, you need to be aware of the proteasome inhibitors and immunomodulators. Examples of proteasome inhibitors include:

• bortezomib,
• carfilzomib, or
• ixazomib.

Immunomodualtor agents include:

• thalidomide,
• lenalidomide, or
• pomalidomide.

When is daratumumab not covered? If your provider is not able to define that daratumumab is medically necessary, you cannot claim for daratumumab.

The following are the three criteria where daratumumab disqualifies as the desired treatment:

1. You cannot claim for daratumumab if your provider has used this drug for first-line therapy in multiple myeloma.
2. You can only submit a claim for daratumumab for multiple myeloma. If your provider used this drug in conditions other than multiple myeloma, including plasma-cell leukemia, then you cannot submit a claim.

Check with your payer: The insurance may request medical records. When you receive a request for medical records, letters of support and/or explanation may also be sufficient. Check with your payer if these would suffice. However, make sure you have all documentation to establish the medical necessity for daratumumab.

Prepare for the Code Reform in 2017

The recommended dose of daratumumab is 16mg/kg body weight. Daratumumab is administered as an intravenous infusion with a weekly schedule for weeks 1-8; every two weeks for weeks 9-24; and every four weeks from week 25 onward until disease progression.

Check dose to calculate units of C9476: For every 10 mg of daratumumab, you submit 1 unit of code C9476 (Injection, daratumumab, 10 mg). Example, if your provider administered 800 mg of daratumumab, you submit 80 units of C9476.

Prepare for the change in 2017: HCPCS code C9476 will apply only for dates of administration till Dec 31, 2016. Effective Jan 1, 2017, you will have a new code for daratumumab, J9145 (Injection, daratumumab, 10 mg). “It is important to note, while the HCPCS code will change, the new code in 2017 will have the same per unit strength of 10 mg,” says Kelly C. Loya, CPC-I, CHC, CPhT, CRMA, Managing Director of Pinnacle Enterprise Risk Consulting Services (“PERCS”), a division of Pinnacle Healthcare Consulting.

Consider the J9999 option: If C9475 is not accepted by the payor, you may want to inquire whether the payor prefers the unlisted HCPCS code J9999 (Not otherwise classified, antineoplastic drugs) for daratumumab.

Note: The prescribing information for daratumumab is available online at the following link: https://www.darzalexhcp.com/shared/product/darzalex/darzalex-prescribing-information.pdf.

Don’t Miss the Diagnosis

When submitting a claim for daratumumab, the diagnosis codes C90.00 (Multiple myeloma not having achieved remission) - C90.32 (Solitary plasmacytoma in relapse) for multiple myeloma may be applicable when the documentation supports their use. In addition, you may check if the code Z85.79 (Personal history of other malignant neoplasms of lymphoid, hematopoietic and related tissues) applies for personal history of hematopoietic malignancy.

Brush Up on These Multiple Myeloma Basics

What is multiple myeloma? Multiple myeloma is a type of blood cancer. It develops in the plasma cells, a type of antibody producing white blood cells, found in the bone marrow. In multiple myeloma, the cancerous plasma cells infiltrate the bone marrow and replace the normal cells in the marrow. These cancerous plasma cells produce abnormal  proteins like the M proteins and cause bone damage, resulting in bone pain or fractures.

What is daratumumab? Daratumumab is a human anti-CD38 monoclonal antibody (mAb) used for the treatment of multiple myeloma resistant to other therapies. Daratumumab binds to CD38 and inhibits the growth of CD-38-expressing tumor cells by inducing cell death through direct as well as alternate cytotoxic pathways.