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CMS Proposes Coverage With Evidence Development for CAR T-Cell Therapy for Cancers

Kristi Rosa
Published: Monday, Feb 18, 2019

Efrem Castillo, MD

Efrem Castillo, MD

The Centers for Medicare & Medicaid Services (CMS) has proposed to cover chimeric antigen receptor (CAR) T-cell therapies approved by the FDA, under “Coverage with Evidence Development,” according to a recent press release issued by the agency.1

The proposal has been issued in response to a formal request made by Efrem Castillo, MD, Medicare & Retirement chief medical officer, at UnitedHealthcare (UHC), who asked for clarification of the circumstances under which FDA-approved CAR T-cell therapies will be covered in order to create consistent patient access to this treatment nationwide as well as financial sustainability in the Medicare Advantage program.


“As UHC anticipates emerging clinical advances, including these CAR T[-cell] therapies, UHC has several concerns that while promising clinically, CAR T[-cell] therapies could create significant financial risks for CMS, both Original Medicare FFS and Medicare Advantage plans,” Castillo wrote in his letter.2

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