On Jun. 22, CMS issued notice on transitional coverage for technology.
CMS issued Notice CMS-3421-NC on transitional coverage for emerging technologies.
Proposed procedural notice outlining a new coverage pathway to achieve more timely and predictable access to new medical technologies for people with Medicare.
Medicare Coverage
The new Transitional coverage for emerging technologies (TCET) pathway for breakthrough devices is intended to support improved patient care and innovation.
Uses current national coverage determination (NCD) and coverage with evidence development (CED) processes to expedite Medicare coverage of breakthrough devices.
TCET is voluntary and aims to reduce uncertainty about coverage options through a pre-market evaluation of potential harms and benefits while identifying evidence gaps.
Also, TCET pathway will help benefit category determination, coding, payment reviews.
Consultation
The public will have 60 days after publication in federal register to provide comment.
Aug. 2024 CMS Final Notice
On Aug. 7, 2024, CMS issued Notice CMS-3421-FN, with changes based on comments.
Allowed manufacturers to submit a non-binding letter of intent to nominate potentially eligible device 18 to 24 months before anticipated FDA marketing authorization.
If CMS is aware that manufacturers will pursue TCET pathway, CMS will conduct clinical endpoints’ review and convene a MEDCAC panel, but letter of intent will prevent delay.
Also revised the timeframe for reviewing TCET nominations and will review quarterly.
If an NCD is opened, an evidence summary, including a disclosure of which contractor completed review, will be posted with tracking sheet on website for public comment.
Evidence Development Plans should incorporate interim reporting to ensure adequate progress and timely completion, and disclose meaningful changes to study protocols.
CMS will disclose proposed factors it will use to prioritize TCET nominations, and until then, will use the language from Aug. 7, 2013, federal register notice (78 FR 48164).
If interested in the TCET pathway, manufacturers need to notify CMS of their interest.
Nominations for first quarterly review must be sent by Oct. 31, 2024, and deadlines for the next three quarterly reviews are Jan. 31, 2025, Apr. 30, 2025, Jul. 31, 2025.
Aug. 12, 2024 Fed Reg Final Notice
On Aug. 12, 2024, CMS published final notice CMS-3421-FN, in the federal register.
Regulators
CMS
Entity Types
Ins
Reference
89 FR 65724, 8/12/2024; Nt CMS-3421-FN, 8/7/2024; PR, Nt CMS-3421-NC, 6/22/2023; Citation: 78 FR 48164;
