Recognized as one of the top lobbyists and negotiators for the medtech sector, Mark Leahey, president and CEO of MDMA and Fogarty Innovation’s board member, continues to make an unparalleled impact on our industry.
Over the course of his career, he has championed efforts to create more reasonable and predictable regulatory pathways for innovators, led initiatives to ensure a more timely and equitable reimbursement process, fostered broader access in the hospital marketplace for all medical devices and spearheaded efforts to repeal the medical device tax.
We had the privilege of sitting down with Leahey to glean the biggest policy takeaways for 2023 and his predictions for what lies ahead in 2024.
Q. What was one of the most significant policy developments for the industry in 2023 that will carry into 2024?
A. In 2023, MDMA continued our proud tradition of being the eyes and ears for medical technology innovators in Washington DC. During the year, there were several hearings in Congress that examined accelerated coverage pathways to improve patient access to medical technologies, and MDMA members had the opportunity to share their views about why advancing this bipartisan goal is essential to innovators.
MDMA has a long and constructive working relationship with both Congress and the Centers for Medicare and Medicaid Services (CMS) focused on advancing policies and initiatives aimed at reducing the time between FDA market authorization and the implementation of coverage, coding and payment changes that support patient access. Last year, we continued our advocacy for accelerated CMS coverage for novel medical technologies. CMS is expected to finalize the draft guidance for Transitional Coverage for Emerging Technologies (TCET) early in 2024. The final guidance is expected to provide more transparency and collaboration within the Coverage with Evidence Development (CED) program. In addition, we continued to work with a broad, bipartisan coalition in Congress to advance H.R. 1691, the “Ensuring Patient Access to Critical Breakthrough Products Act,” a legislative proposal that is designed to build upon the expected TCET reforms.
It was disappointing that a broad and robust TCET program was not instituted in 2023, but there remains substantial support in Congress to accelerate patient access to novel medical technologies in 2024.
Q. For 2024, what are some of the key trends you are seeing?
A. As you know, 2023 was the first full year of the implementation of the MDUFA V user fee agreement. The MDUFA V agreement is intended to drive more capacity, consistency and transparency with the premarket review program. Fortunately, FDA has moved beyond the COVID workload surge and they are meeting many of the various MDUFA V performance goals and milestones that are included in the agreement. We expect this trend to continue in 2024 and beyond.
Additionally, MDMA continues to seek other ways to make the premarket review process more predictable and transparent. Over the past few years, our members have shared increasing concerns regarding unreasonable questions and data requests around biocompatibility and human factors that are ultimately causing delays for patient access. MDMA is working closely with the FDA to address these concerns, and create more reasonable and efficient interactions with medical technology innovators.
Q. What is one of the biggest issues you are working on for 2024 and, based on your insights, what advice would you give startups to help them navigate this landscape?
A. Ethylene oxide (EtO) sterilization of medical devices remains a critical issue that MDMA is working on with various stakeholders. As FDA has noted, 20 billion medical devices are sterilized via EtO annually and for most, it is the only validated method. The EPA is expected to issue a final commercial sterilization rule on EtO sometime before March 1, 2024, and MDMA is engaged with various agencies and stakeholders as the EPA is also looking to update registration requirements for EtO facilities by the end of 2024. If either one of these two rules are not issued responsibly, there will be a reduction of EtO sterilization capacity and that will adversely impact the supply chain and patient access. As FDA noted after the EPA began looking into this issue in 2019, without an adequate availability of EtO sterilization capacity in the United States, the impact to patient care could be “catastrophic.”
MDMA is also working closely with our members and many others to help ensure that the powerful story of medical technology innovation is being told to policy makers as they work on various proposals. As always, we strongly encourage startups to remain engaged with their supporters, trade groups, investors and other stakeholders who are working on key policy issues while they are busy developing the cures and therapies of tomorrow. It is critical to recognize how quickly the landscape can change, especially at a time where there is unfortunately more partisanship in Congress.
The good news is that our ecosystem continues to have broad, bipartisan support because of all the important work that is being done to improve patient outcomes and save lives. I strongly encourage all startups to leverage the resources, advocacy and support that MDMA and many others provide as they continue to pursue their goals.