The U.S. CMS has a few changes in mind for the new technology add-on program (NTAP) for fiscal year 2024, including a proposal to allow manufacturers to apply for an NTAP payment only after the sponsor has filed a completed premarket application with the FDA. Perhaps more significantly, the deadline for FDA approval would also be moved up earlier in the calendar year, from July 1 to May 1, a change that could eliminate a year of NTAP eligibility for a significant number of products.
The U.S. Centers for Medicare & Medicaid Services (CMS) has wrapped up its rulemaking for the next Medicare inpatient prospective payment system, and several companies managed to score important rate-setting wins for their devices. Microtransponder Inc., of Dallas, won a new technology add-on payment (NTAP) for its Vivistim device for treatment of stroke, as did W.L. Gore & Associates Inc. for its TAG thoracic branch endoprosthesis (TBE), just two among several winner in the Medicare inpatient final rule for fiscal 2023.
Except for breakthrough devices and qualifying infectious disease drugs, the footwork for getting Medicare's new technology add-on payment (NTAP) can be more challenging than that needed to win FDA approval. It could be even tougher for products that use artificial intelligence (AI) or that follow a subscription model for pricing.
Innovation is being rewarded under Medicare’s proposed fiscal 2021 Inpatient Prospective Payment System (IPPS) that was unveiled Monday. For starters, the Centers for Medicare and Medicaid Services (CMS) is proposing a new Medicare-severity-diagnosis related group (MS-DRG) specifically for CAR T therapies.