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.
The Medicare inpatient draft for fiscal 2022 reflects the effects of the COVID-19 pandemic on claims data for a large number of devices, including those that received additional reimbursement under the new technology add-on payment (NTAP) program. Device makers are urging CMS to add a second year of extension to those NTAP payments, however, a proposal which if adopted would give the affected device makers additional time to recoup their investments.
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.