See update adding CRC Screening (bottom of this page)
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Recently, CMS released its final verson of TCET - transitional coverage for emerging technologies.
They say they plan to do up to five TCET NCDs per year. These are uniquely for FDA breakthrough devices, which will work with CMS up to a year in advance, and which should receive an NCD with CED (coverage with evidence development) within 6 months of FDA approval.
Is it practical? CED or pragmatic trials are among the hardest types to design well, and few at CMS have clinical trial experience (e.g. working in leadership roles on large clinical trials recently at major universities, or working in pharma as a clinical trial medical director). In addition, the output of NCDs in the last twelve months was only 4, and one of those was merely deleting an existing NCD (amyloid PET).
The NCD Backlist at CMS.gov
CMS publishes a backlist of NCD requests at CMS.gov - here.
https://www.cms.gov/files/document/ncd-dashboard.pdf
The most recent is from May 15, 2024, and shows 2 NCDs in process, 4 completed in 12 months, and 8 on backlog (request on backlog).
I submitted a FOIA request for NCD requests comprises the backlog, on October 15, 2023. It arrived today (August 26, 2024).
First, let's compare the August 2023 backlog and the May 2024 backlog (click to enlarge):
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Of 7 NCD requests backlogged in August 2023, one was opened (pulmonary pressure sensor; "status open May 2024"). Two NCDs were added to backlog, raising the total from 7 to 8.
Now let's see some statistics from the 276-page PDF of requests I got from FOIA:
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The NCD requests were from 2 to 91 pages long. Some had a lengthy journal article attachments; others went on with many, many pages of their own original text.
Some topics (like HPV screening or HCV screening) had multiple requests from different stakeholders over 2 years.
NCD Backlist vs TCET
If CMS has a capacity of 4-6 NCDs per year (including simple ones) and a backlog of five to ten 3-year-old requests, could it add 5 complex CED NCDs per year via the TCET process? Would they displace most of the non-TCET NCDs? Or will it all work out OK?
Update: CMS updated the list on 8/15/2024 by adding Colorectal Screening to the top of the list.
