BMTA Newsletter, September 4, 2024

Updates – U.S. Reimbursement for Medical Technologies and Healthcare services

David Barone, Principal of BMTA, will discuss U.S reimbursement during the September 24 meeting of the Life Science Collaborative (Boston). Copy of the presentation, which will include updates on recent developments in this area, will be available following the meeting. To pre-register for a copy please contact BMTA.

Industry News:

TCET Program

The Centers for Medicare & Medicaid Services (CMS) has released the Transitional Coverage for Emerging Technologies (TCET) Pathway final notice to provide early coverage for certain FDA-designated Breakthrough Devices.

As discussed in our blog, CMS will initially accept up to 5 TCET candidates per year, with the goal of providing an expedited path to a National Coverage Determinations (NCD) within six months of FDA market authorization.  CMS is expected to release in the coming weeks the proposed factors it will use to prioritize TCET nominations.

CMS noted several changes in the final notice, including:

• Manufacturers can submit a letter of intent to nominate a device for TCET 18-24 months before the expected FDA marketing authorization.
• Evidence Development Plans submitted by manufacturers of candidate devices must include interim reporting to ensure progress and timely completion.
• CMS may convene a Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) panel to help review planned clinical studies.
• If an NCD is opened, an evidence summary and disclosure of the contractor will be posted for public comment.

Manufacturers should notify CMS by October 31, 2024 of their interest in being considered for the first group of Breakthrough Devices considered for the TCET program. Subsequent deadlines are January 31, April 30, and July 31, 2025. For more information, visit the Federal Register. For assistance in this process or discuss how to integrate FDA Breakthrough Designated Device and TCET into your strategy, please contact BMTA. 

FDA Updates on AI Devices

The FDA has recently approved 61 new artificial intelligence and machine learning (AI/ML)-enabled medical products, bringing the total number of approved AI/ML devices to 952. This ongoing growth in the availability of AI/ML technology within the medical field highlights its increasing adoption. According to the FDA’s AI/ML database, radiology remains the dominant field, accounting for over 75% of products, followed by cardiovascular (10%) and neurology (3%). Despite regulatory approvals, AI/ML medical product adoption by providers is hindered by significant delays in insurance reimbursement as only 11 devices have been assigned payment by CMS.

The FDA’s Digital Health Center of Excellence has recently developed the AI Lifecycle (AILC) as a framework to guide the development of safe and effective AI-powered medical devices. The AILC maps traditional software development processes to the specific requirements of AI, covering planning, data management, model building, testing, deployment, monitoring, and evaluation. By following the AILC, developers can create AI tools that are reliable, ethical, and beneficial for healthcare.

BMTA supports manufacturers to develop plans supporting adoption of new technologies, including AI/ML devices, including optimal regulatory and reimbursement strategies.

FDA 2025 User Fee Rates

The FDA has published its updated user fee rates for fiscal year 2025 (effective October 1, 2024, through September 30, 2025).  The Medical Device User Fee Amendment (MDUFA V) presents a 12% increase for each application type . For a 510(k) application, user fees increased from $21,760 to $24,335 (from $5,440 to $6,084 for a CDRH-certified small business), and for a De Novo application, fees increased from $145,068 to $162,235 ($36,267 to $40,559 for small business).  

For assistance in navigating FDA user fees, please contact BMTA.

About Boston MedTech Advisors (BMTA)

Since 2004, BMTA’s multidisciplinary team has supported over 400 medical technologies and life sciences companies to achieve their business goals. BMTA assists its clients to commercialize new products and services and increase their market adoption by addressing their unique and inter-dependent regulatory, clinical evidence, reimbursement, and marketing plans. BMTA offers results oriented insights that recognize the multi-faceted aspects of today’s healthcare markets and the client’s unique business needs.

For more information, questions, or comments, contact us at info@bmtadvisors.com

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