In the past few weeks, AdvaMed has published several important examples of policy thought capital for CMS.
AdvaMed and TCET
First, on August 1, they released an 8 page memo to CMS on how it could implement a new "TCET" or transitional coverage pathway.
Among other things, they suggest a process that resembles the Medicare process for "Investigational Device Exemption" or IDE trials. CMS pays for medical devices in IDE FDA trials if the basic health outcomes are understood. For example, a new variant of a heart valve, or a prosthetic knee, or a pacemaker. The original FDA-CMS rulemaking goes back to 1995 and was very well written. Basically, the patient is getting one pacemaker, and CMS pays for it, whether it's approved model 101 or an updated model 101B in a clinical trial. See back-references inside a 2017 FDA update here.
IDE trial coverage is now an accelerated and fairly straightforward process managed by CMS coverage staff. See the CMS IDE web page here. Basically, a TCET version would be similar except without the FDA IDE trial starting point.
AdvaMed and Software as a Service
Within its general comment to CMS on the OPPS rule for Summer 2022, CY2023, Advamed has some instructive comments on how CMS is handling, could handle, and should handle software reimbursement. AdvaMed notes this needs to be extended to AI and Machine Learning and that CMS should hold an open call for comments on this topic. See the SAAS section inside this document, page 19-22:
If of interest: See my new 5 minute video "mini course" on CMS, MCIT, TCET, CED policy alphabet:
