ARTICLE SUMMARY:
CMS awards a record number of new technology add-on payments for medical devices. Excerpted from Pathways’ Picks August 7: Medicare Picks, FDA Fee Hike, EU Orphan Pilot, and More.
CMS granted new-technology add-on payments (NTAPs) to a record 11 medical devices (including one drug-device combination product) starting October 1. That is the highest single-year total since the program launched in 2021, according to tracking by Market Pathways. The Medicare agency affirmed the bonus reimbursement awards in its FY 2025 hospital inpatient prospective payment system (IPPS) final rule published August 1.
Ten of the NTAPs were awarded to FDA Breakthrough Devices, which benefit from a streamlined CMS review. The other one, for the HEPZATO drug/device combo product for treating liver cancer, cleared the agency’s traditional review process to earn the payment. The record haul (the previous high was nine device NTAPs awarded in FY 2024) came even as CMS has recently taken steps to restrict NTAP eligibility, by requiring devices to be FDA-authorized earlier in order to qualify and by establishing new requirements for a company to show it has a “complete and active” submission under review by FDA. (See “CMS Pushes Back on New-Tech Pay Applications, But Activity Remains Strong,” Market Pathways, August 6, 2024.)
In addition to awarding the new NTAPs in the FY 2025 final rule, CMS also followed through with some NTAP policy updates. In particular it loosened the “complete and active” requirement by specifying that FDA placing a “hold” on an application doesn’t disqualify the device from an NTAP. It also updated a cut-off date in a manner likely to expand the number of devices that can qualify for one extra year of NTAP payments. Under the NTAP program, hospitals receive an extra, targeted reimbursement to cover the costs of new technologies for two to three years while CMS works out the proper long-term payment policy for the products.