CMS coverage changes regarding CAR T Therapies
Recently, the Centers for Medicare and Medicaid Services (CMS) posted two announcements which impacts payment and coverage for Chimeric Antigen Receptor T-Cell (CAR T) Therapies. This email will provide a brief summary of the Fiscal Year (FY) 2020 Inpatient Prospective Payment System (IPPS) Final Rule, and the National Coverage Determination (NCD) for CAR T cell therapy for Cancers with a link to both announcements.
Summary of the IPPS Final Rule for FY 2020 and its impact on CAR T
On August 2, 2019, CMS released the IPPS Final Rule for FY 2020. Under this Final Rule, CMS continued the New Technology Add-on Payment (NTAP) for Fiscal Year 2020 for CAR T cell therapies, including Yescarta® (axicabtagene ciloleucel), and increased the NTAP, beginning with discharges on or after October 1, 2019, from 50% to the lesser of 65% of the costs of the new technology or 65% of the amount by which the costs of the case exceeds the standard DRG payment. CMS noted that the increase in the NTAP percentage to 65% represents a 30% increase from the current 50%. CMS declined to implement a new MS-DRG for CAR T-cell therapies noting there isn’t comprehensive clinical and cost data at this time. The link to this rule was posted to the Federal Register on August 16, 2019 and can be accessed at https://federalregister.gov/d/2019-16762.
Summary of National Coverage Determination (NCD) for CAR T
On August 7, 2019, CMS finalized its National Coverage Determination (NCD) for CAR T cell therapy for Cancers which confirmed coverage for Yescarta® As a result of this NCD, coverage will be provided consistently on a national basis for the Medicare fee-for-service population. In their Decision Summary CMS stated:
The Centers for Medicare & Medicaid Services (CMS) covers autologous treatment for cancer with T-cells expressing at least one chimeric antigen receptor (CAR) when administered at healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) and used for a medically accepted indication as defined at Social Security Act section 1861(t)(2) i.e., 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.
The use of non-FDA-approved autologous T-cells expressing at least one CAR is non-covered. Autologous treatment for cancer with T-cells expressing at least one CAR is non-covered when the requirements in Section A are not met.
This policy continues coverage for routine costs in clinical trials that use CAR T-cell therapy as an investigational agent that meet the requirements listed in NCD 310.1.
The link to the CAR T Therapy for Cancers NCD is https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=291&bc=AAAAAAAAACAA&
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