According to CMS, they've begun promoting town halls in February and March that will discuss, "Transitional Coverage for Emerging Technologies." (?"TCET")Early in January, this was reported a rulemaking in progress (see blog January 7, 2022.) This could be, in effect, a replacement or reboot for the canceled plan for MCIT, "Medicare Coverage for Innovative Technologies." The MCIT would have provided 4 years of coverage for FDA-endorsed Breakthrough Devices. A program similar to MCIT has been included within drafts of a new, 2022-vintage "21st Century Cures" bill that is in progress.
CMS has promised to produce a new version of a breakthrough device program in CY2022 (see for example Modern Healthcare, 12/2021).
According to staff at the office of communications, CMS will hold teleconferences on February 17 and March 31 on the topic. Look for further social media from CMS on the topic. Details below the break.
See a two minute video version of this blog:
Following the repeal of the January 2021 Medicare Coverage of Innovative Technologies and Reasonable and Necessary (MCIT/R&N) Final Rule, CMS remains committed to establishing an alternative expedited coverage pathway and other coverage process improvements.
Please join Principal Deputy Administrator Jonathan Blum and the Center for Clinical Standards and Quality for the first of two distinct listening sessions. As CMS Administrator Chiquita Brooks-LaSure outlined, (fn1) CMS is working “with the FDA, Agency for Healthcare Research and Quality (AHRQ), medical device manufacturers, and other stakeholders to develop an expeditious process to cover innovative devices that benefit Medicare patients, and intends to hold at least two stakeholder public meetings in CY 2022 to inform our future policy-making in this space.”
These meetings are part of several steps CMS is taking to help better achieve the goals of timely and predictable Medicare coverage of devices while ensuring that Medicare covers items and services on the basis of scientifically sound clinical evidence and with appropriate safeguards. We appreciate all of the valuable stakeholder feedback received to date as we engaged in several iterations of rulemaking on this topic. The second listening session on March 31 at 3:00 PM ET will build on information gathered in the first session. We encourage stakeholders to attend both meetings. You’ll be able to register for the series by following the link below.
What: CMS Listening Sessions on Transitional Coverage for Emerging Technologies
For the initial meeting, we are particularly interested in having stakeholders communicate any new and innovative approaches and ideas for us to consider as we move forward.
When: February 17, 2022 3:00 - 4:00 PM ET with a subsequent session on March 31, 2022.
Who should attend: This listening session series is designed for all Medicare and Healthcare Partners.
Please RSVP by Wednesday, February 16, 2022.
For policy wonks, I've provided an informal listing of some MCIT policy links here.
CMS has been holding more listening sessions in addition to comment periods. For example, during the consideration period of a recent draft NCD on aducanumab for Alzheimer's disease, CMS held two listening sessions with 360 attendees, in addition to the standard written public comment period.