MAC LCDs Versus CMS NTAP Payments: Case Study with Procept Aquablation

To encourage the progress of important inpatient technologies, for many years Congress and CMS have allowed New Technology Add-on Payments (NTAPs).  These provide partial payment (50-70%) for the costs of new inpatient technologies, if CMS determines the technology provides a substantial improvement in health outcomes for Medicare patients.   The NTAP payment is temporary - 2-3 years - after which CMS assumes the new costs have been rolled into annual DRG payment rates.

For some entry points, see CMS home page here, CMS policy for NTAP for new antibiotics here, a 2019 summary at the health consultancy Avalere here, and a law firm summary of recent updates here.

• Policy watchers for medical devices will be aware of a few maddening examples where a new technology met "substantial improvement' standards at CMS, but failed to win LCD coverage before an NTAP expired.

New Example: Procept Aquablation Comment Letter to CMS, 7/10/2020

The FY2021 inpatient rule comment period just closed on July 10, and contains a detailed letter on this topic.   See the letter in the cloud here.  

Procept argues that its NTAP period must be extended because, due to LCDs against its "Category III codes," it hasn't been covered by CMS.   I think they have a good point.  Anyone who's dealt with the LCD process in the last couple years is aware of the glacial timelines.

The first 8 pages of the letter hold the policy and legal arguments; the next 185 pages are copies of the relevant LCDs.