The Centers for Medicare and Medicaid Services (CMS) recently released its fiscal year 2020 Inpatient Prospective Payment System (IPPS) final rule. Among the changes announced in this final rule is an increase in the Medicare reimbursement rate for the product cost of chimeric antigen receptor T-cell (CAR-T) therapy from 50% to 65%.1

CAR-T therapy is a multistep process that involves genetically manipulating harvested T cells to improve their ability to recognize and kill cancer cells followed by the reintroduction of the manipulated T cells into the patient after immunodepletion. The therapy is often a last option for patients with relapsed/refractory blood cancer who have not had success in managing their disease with other treatments. To date, 2 CAR-T therapy products are approved by the US Food and Drug Administration (FDA): tisagenlecleucel (Kymriah®) and axicabtagene ciloleucel (Yescarta®).

The American Society of Hematology (ASH) previously submitted comments on the IPPS for Acute Care Hospitals, calling on the CMS to increase the new technology add-on payment (NTAP) to 80% and suggesting a payment structure for fiscal year 2020 and fiscal year 2021 and beyond.2 The IPPS applies to more than 3000 hospitals in the United States. ASH’s NTAP proposal would also apply to other and future new technologies.

The average sales price for these products is $373,000.2 With this increase, CMS would cover $242,450 of the product cost for institutions that can offer CAR-T therapy.

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“Increasing the amount institutions will be reimbursed for the product cost of CAR-T is a positive step toward making this potentially life-saving therapy more accessible to the patients whose lives it can save,” 2019 ASH President Roy Silverstein, MD, of the Medical College of Wisconsin in Milwaukee, said in a statement issued regarding CMS’ announcement. “However, we are disappointed that CMS did not take additional steps to address the barriers faced by institutions in recouping the cost of the product as well as the cost of additional medical care these patients require.

“Some centers are unable to offer CAR-T to Medicare beneficiaries because the overall cost of paying for the treatment and caring for patients, who often must receive care in the intensive care unit, is unsustainable,” Dr Silverstein explained in his statement.

Had CMS accepted the suggestions from ASH, the agency would cover $298,400 of the product cost for all institutions.2 Although this would still leave a high product cost for many institutions, the higher reimbursement could alleviate more of the overall cost of providing this treatment.

References

1. Statement from ASH President Roy Silverstein, MD, on Medicare Reimbursement for CAR T-Cell Therapy [press release]. American Society of Hematology; August 6, 2019. https://www.hematology.org/Newsroom/Press-Releases/2019/9840.aspx. Accessed August 7, 2019.

2. ASH Comments on IPPS Final. Letter submitted electronically via regulations.gov; June 24, 2019.