ARTICLE SUMMARY:
In this week’s Pathways Picks: CMS launches the Transitional Coverage for Emerging Technologies (TCET) pathway and awards a record number of new technology add-on payments for medical devices; FDA user fee rates jump, including a “performance improvement” adjustment; CDRH plans its first Digital Health Advisory Committee meeting; the European Medicines Agency launches an orphan device pilot; China publishes a guidance on quality inspections; and more global medtech policy updates.
Top Picks: Medicare News
TCET finalized. Device manufactures can now start notifying CMS of their interest in participating in the new Transitional Coverage for Emerging Technologies program. The agency published a final notice launching TCET August 7 and set October 31 as the first quarterly deadline for nominating devices to access the streamlined pathway for national Medicare coverage. TCET is a voluntary program directed at making the path from regulatory authorization to national coverage more timely and predictable for select FDA-designated Breakthrough Devices. It will leverage earlier CMS evidence reviews and interactions between the agency and manufacturers, and clearer clinical guidance from the Medicare agency. The pathway described in the August 7 notice is very similar to what CMS proposed last June, where a manufacture would initiate contact with CMS during FDA review of a candidate device and the Medicare agency would assess available and outstanding evidence to support coverage.. For qualifying devices, CMS’ goal will be to issue a final National Coverage Determination with evidence development requirements within six months of FDA authorization. CMS made several tweaks from its original proposal, in particular allowing companies to submit a “non-binding letter of intent” to nominate its device to TCET 18-24 months before FDA authorization is expected. But the final plan still incorporates several fundamental limitations that have been highlighted by industry groups, including:
- TCET leverages the existing NCD process, rather than a new pathway
- CMS expects to cap the number of devices accepted into TCET annually at five
- The agency doesn’t anticipate IVDs will leverage TCET in most cases
In conjunction with publishing the final TCET notice, CMS also finalized three relevant guidance documents on: coverage with evidence development, evidence review for national coverage analysis, and a clinical endpoints guidance addressing knee osteoarthritis. CMS says it will soon issue a document outlining proposed factors that the agency will use to prioritize TCET nominations.
Record year for NTAPs. CMS granted new-technology add-on payments (NTAPs) to a record 11 medical devices (including one drug-device combination product) starting October 1. That is the highest single-year total since the program launched in 2021, according to tracking by Market Pathways. The Medicare agency affirmed the bonus reimbursement awards in its FY 2025 hospital inpatient prospective payment system (IPPS) final rule published August 1.
