- A drug-eluting stent from Boston Scientific, an implantable fracture reduction system sold by Stryker, and an endoscopic hemostat manufactured by Cook Medical are among the medical devices that secured new technology add-on payments from CMS as laid out in the 2021 Inpatient Prospective Payment System rule published Wednesday afternoon. The rule takes effect Oct. 1.
- Not all applicants for the extra payments, which CMS reserves for hospitals implementing "new and relatively high cost" technologies meeting certain criteria, were successful. A BD device used in creating hemodialysis access and a pneumonia panel from BioFire Diagnostics were among the products the agency said it could not approve without further evidence of substantial clinical improvement.
- Two heart failure devices — the Barostim Neo system from CVRx and Optimizer system from Impulse Dynamics — received add-on payments from an alternative version of the pathway reserved for FDA-designated breakthrough devices. Applicants with the special designation and marketing authorization from FDA that also meet CMS cost criteria could qualify for add-on payments without necessarily demonstrating substantial clinical improvement over existing treatment options.
New technology add-on payments (NTAP) are one of the Medicare agency's tools to support speedier adoption of novel medical devices meeting certain cost and clinical improvement criteria following FDA authorization. The payments are equal to either 65% of the cost of the service or technology, or 65% of the amount by which the costs of the case exceed the base MS-DRG code reimbursement.
When combining the medical device NTAP recipients with others including drug therapies, CMS said a record 24 technologies are eligible to receive add-on payments in the coming year, estimating spending on the payments will total roughly $874 million, a 120% increase over the prior year.
In finalizing Boston Scientific's Eluvia drug-eluting stent as a recipient, CMS acknowledged FDA red flags last year over the safety of paclitaxel-eluting devices. The agency also noted that while Eluvia is included in that class of devices, that particular product was not included in the meta-analysis that signaled potential late mortality among peripheral artery disease treated with the devices.
Viz.ai, a software startup with FDA-cleared products that counts Medtronic as a distribution partner, claimed its successful NTAP application for its stroke detection software, the first time CMS has awarded an add-on payment to artificial intelligence software.
In addition to the BD and BioFire devices missing the CMS cut this year, the agency also found a supersaturated oxygen therapy from Zoll Medical-owned TherOx and a brain tumor therapy from GT Medical to be inadequate for the second year in a row.
Within the alternative pathway for breakthrough devices, AngioDynamics failed to successfully make the case for its NanoKnife treatment for pancreatic cancer, an indication that did not receive FDA authorization by the July 1 deadline laid out by CMS.
As CMS grows its NTAP spending, it's also in the process of easing initial reimbursement decisions for breakthrough devices. The agency issued a proposed rule this week that could automatically award breakthrough devices four years of national coverage immediately upon FDA authorization.