The Centers for Medicare & Medicaid Services (CMS) is seeking public comments in June on two initiatives that have important ramifications for CAR T-cell therapies.
New Technology Add-On Payment Proposal
In rare cases, CMS may provide hospitals with additional payment in the form of a New Technology Add-On Payment or NTAP, for a period of two to three years for new, high-cost technologies used in the inpatient setting.
CMS is considering whether to approve NTAP payments to hospitals for administering a CAR T-cell therapy in the inpatient setting, effective October 1, 2018, and is currently seeking stakeholder input. Stakeholders can weigh in by submitting a comment letter to CMS by June 25, 2018.
Comment letters should reference the “CAR T-cell Therapy NTAP Application” and the CMS proposed rule that discusses these payments: “Medicare Inpatient Prospective Payment System Proposed Rule for FY2019 (CMS-1694-P).” Comment letters may include provider feedback on the importance of CAR T-cell therapies and the potential access barriers for Medicare beneficiaries. Letters can be submitted and uploaded in PDF format online here.
Click here to view the CAR T-cell Therapy NTAP discussion from the proposed rule.
National Coverage Analysis
CMS recently issued a national coverage analysis (NCA) tracking sheet for CAR T-cell Therapy, indicating that the agency plans to convene a Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) meeting on August 22, 2018, to review the available clinical evidence on this therapy. CMS announced that the NCA is expected to be completed by May 17, 2019. As part of the NCA, CMS may issue a National Coverage Determination (NCD) describing the circumstances for Medicare coverage nationwide for CAR T-cell Therapy.
The agency is currently seeking public comment on clinical studies and other scientific information relevant to CAR T-cell Therapy. Providers can also comment on patient access concerns by submitting a letter to CMS by June 15, 2018. Comments can be submitted online here.