CAR T-Cell Therapy Billing Instructions: Medicare Claims Processing Manual Update

Related CR Release Date: December 23, 2025
MLN Matters Number: MM14247
Effective Date: October 1, 2025 
Related Change Request (CR) Number: CR 14247
Implementation Date: January 26, 2026 
Related CR Transmittal Number: R13460CP

CR 14247 acknowledges:

  • CMS adjusted the payment for claims that group to Medicare Severity Diagnosis-Related Group (MS-DRG) 018 when: 
    • The case involves a clinical trial for CAR T-cell therapy
    • There’s expanded access use of CAR T-cell therapy or another immunotherapy product
    • You don’t purchase the CAR T-cell therapy product in the usual manner, such as obtaining it at no cost
  • CMA won’t apply a payment adjustment to claims that group to MS-DRG 018 when the case involves a clinical trial of a different product

Make sure your billing staff knows about the billing instruction updates and payment requirement scenarios in the Medicare Claims Processing Manual, Chapter 32, section 400.3.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)14247.

Last Updated Jan 08 , 2026