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.