Now that revolutionary cancer therapy, Chimeric Antigen Receptor T-cell (CAR T-cell), is covered, let’s take a look coding CAR T. Last month the Centers for Medicare & Medicaid Services (CMS) finalized the long-sought rules for coverage of CAR-T, novel cutting-edge, often curative treatments that utilize the patients’ own genetically modified immune cells to fight cancer.

The article posted earlier this month, Innovative CAR T-Cell Cancer Therapy Now Available to Medicare Beneficiaries, broke down Gilead Sciences’ Yescarta (axicabtagene ciloleucel) for acute lymphoblastic leukemia and Novartis’ Kymriah (tisagenlecleucel), approved for non-Hodgkin lymphoma, and how this decision will impact Medicare patients. Coders need to understand these newly covered procedures and the codes surrounding their use, so let’s delve into coverage and proper code assignment for CAR T-cell therapy.

CAR T-cell Therapy – Background and Coverage 

CAR T-cell therapy is a cell-based gene therapy where a patient’s own T lymphocytes (T-cells) are extracted and chemically reengineered in a laboratory to produce chimeric antigen receptors (CARs) on their surface that bind to a specific protein expressed on a patient’s cancerous cells. The genetically modified CAR T-cells are then infused back into the patient, now able to recognize and kill cancer cells that have the targeted antigen on their surface.The therapies, despite being revolutionary for certain types of cancers, have experienced difficulty gaining traction. This has been primarily due to confusion over CMS’s rules and reluctance on the part of payers to pay for this expensive intervention.

Under the new policy, Medicare will cover CAR-T therapies provided that are administered in healthcare facilities that follow the Food and Drug Administration’s (FDA) special safety rules, known as risk evaluation and mitigation strategies (REMS).  Medicare will provide coverage of CAR T-cell therapies for FDA-approved indications as well as for off-label uses that are recommended by CMS-approved compendia, which are used to determine medically accepted uses of drugs and biologics. See the proposed decision memo for details surrounding coverage requirements.

Coding CAR T-cell Therapy 

Yescarta, coded with HCPCS Level II code Q2041, has a list price of $373,000. Yescarta’s sole challenger Kymriah (tisagenlecleucel), coded with Q2042, lists for $475,000. CMS has assigned ICD-10-PCS codes XW033C3 and XW043C3 to the use of these immunotherapies in the inpatient setting for fiscal year 2019. You will find the codes for reporting CAR T therapy administration below.

While CMS recognizes the need to cover these transformative life-saving treatments, no one is sure what the overall cost to the Medicare program will be or how the system will pay for this in the years to come. CMS Administrator Seema Verma has declined to give any estimates of how much this new coverage will cost hospitals or how CMS plans to address the enormous expense of these novel therapies.

The administration of CAR-T therapy involves the following codes:     

See The American Society for Transplantation and Cellular Therapy’s coding guidance charts for more information.