Knowledge Base Article

Did You Know?

CAR T-cell Therapy entails the use of CAR T-cells that have been genetically altered to improve the ability of the T-cells to fight cancer. The genetic modification creating a CAR can enhance the ability of the T-cell to recognize and attach to a specific protein, called an antigen, on the surface of a cancer cell.

In 2017, the FDA gave approval to two CAR T-cell therapies (Kymriah® and Yescarta®). Effective October 1, 2018, both therapies were approved for new-technology add-on payments with a maximum add-on payment of $186,500.

Effective for claims with dates of service on or after August 7, 2019, Medicare began covering autologous treatment for cancer with T-cells expressing at least 1 Chimeric Antigen Receptor (CAR) when the treatment is:

• Administered at healthcare facilities enrolled in the FDA Risk Evaluation and Mitigation Strategies (REMS), and
• Is used for a medically accepted indication as defined at section 1861(t)(2)-i.e., or
• Is used for either an FDA-approved indication (according to the FDA-approved label for that product, or for other uses when the product has been FDA-approved and the use is supported in one or more CMS-approved compendia.

Not surprisingly, CAR T-cell therapy is expensive. So much so that CMS clinical advisors noted in the Fiscal Year (FY) 2021 IPPS proposed rule that they had found a vast discrepancy in resource consumption and clinical differences warranting the creation of new MS-DRG. Effective October 1, 2020, CAR T-cell therapy had its own MS-DRG 018 (Chimeric Antigen Receptor (CAR) T-cell immunotherapy).

In the current CMS FY 2022, MS-DRG 018 has a relative weight of 37.4501. On the October 1, 2022, start date of the CMS 2023 FY, MS-DRG 018 will once again have the highest relative weight at 36.1452.

Since 2017, the FDA has approved additional CAR T-cell therapies. Three of these are eligible for a New Technology Add-On Payment (NTAP) in Fiscal Year 2023:

• ABECMA® and CARVYKTI ™ to treat patients with relapsed or refractory multiple myeloma with a maximum add-on payment of $289,532.75, and
• TECARTUS® to treat relapsed or refractory mantle cell lymphoma with a maximum add-on payment of $259,350.00.

Why it Matters?

In addition to CMS guidance, several of the Medicare Administrative Contractors (MACs) have published guidance regarding CAR T-cell therapy. If your hospital provides this service, I encourage you to become familiar with both CMS and the MACs guidance.

CMS Guidance

• National Coverage Determination Chimeric Antigen Receptor (CAR) T-cell Therapy (NCD 110.24): (link)
• MLN Matters Article National Coverage Determination (NCD 110.24): Chimeric Antigen Receptor (CAR) T-cell therapy – This CR Rescinds and Fully Replaces CR 11783 (MM12177): (link)
• MLN Matters Article Chimeric Antigen Receptor (CAR) T-Cell Therapy Revenue Code and HCPCS Setup Revisions (SE19009): (link)
• MLN Matters Article International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs) – January 2023 Update: link)
• Note: Revisions to NCD 110.24 include updated codes and coding guidance for all currently available CAR T-cell therapies.

MAC Specific Guidance

• CGS J15 (KY and OH) Article (link)
• NGS JK (CT, NY, ME, MA, NH, RI, VT) FAQs (link)
• Novitas JH (AR, CO, LA, MS, MN, OK, TX) Article (link)