The show must go on, especially when it is something as important to the industry as the MDMA’s Medical Technology Executive Forum, now in its 13th year. Hosted by MDMA president and CEO Mark Leahey, the virtual event was extremely successful, highlighting how nimble and effective the organization is in serving its members during this critical time, as the industry deals with uncertainty stemming from COVID-19 and the upcoming election.
The event began with a keynote “fireside chat,” between Mark and Seema Verma, administrator of the Centers for Medicare & Medicaid Services (CMS), who discussed key CMS priorities. Another much-anticipated session later in the day featured Tamara Syrek Jensen, director of the coverage and analysis group for the Centers for Medicare & Medicaid Services, who explored several new proposed rules and regulations that CMS has issued designed to expedite patient access to innovative medical technologies.
The lively bipartisan duo of Josh Holmes, president and founding partner of Cavalry, LLC, and Andrew Rosenberg, partner at Thorn Run Partners, held a spirited discussion about the 2020 election, with their predictions and impacts. Later in the day Jeffery Shuren, MD, director of the Center for Devices and Radiological Health (CDRH) within the FDA, discussed the latest policies and strategies the FDA is developing to confront the COVID-19 pandemic; Leslie Trigg, CEO of Outset Medical shared perspectives from the C-suite on what it took to thrive while confronting the challenges posed by COVID-19 and how to plan for the future; Russell Robbins, MD, AVP clinical informatics and medical director for Blue Health Intelligence discussed how big data can change your investment strategy; and the final session featured Hussein Akhavannik, a partner at BakerHostetler, who co-chairs the medical life sciences group, discussing patent strategy and associated costs during medical device development. Here are some of the highlights:
CMS supports innovation
As part of its effort to “put patients over paperwork,” CMS has been taking action from day one of the pandemic, quickly changing reporting guidelines and expanding opportunities in telehealth. There has been a lot of innovation that was spurred by COVID-19, creating potentially a banner year on approvals, along with a healthy pipeline for other technologies.
A lot of the efforts have been tailored around making sure that Medicare patients have ready access to the latest technology and treatment, which included easing the process and eliminating some regulatory barriers that can also help lower costs. Most notably, Medicare proposes providing immediate coverage for four years when the FDA has cleared a technology with a breakthrough designation, as part of the proposed “Medicare Coverage of Innovative Technology.” The agency aims to be closely aligned with the FDA so there aren’t any hiccups: Once a device is FDA approved, it will also be eligible for coverage, coding and payment on that day.
By making it easier for innovators, the agency seeks to help more patients and lower the cost of care.
The election is a wild card
With a knowledgeable deep dive into various races that are bound to have an impact, Josh and Andrew shared their view on which states will be most pivotal.
In general, it appears that former Vice President Biden has a durable, although not huge, lead in many states that matter. The work is cut out for President Trump to figure out how to win over one or two states where the electoral votes were the muscle behind his 2016 victory. As has been forecast, many don’t expect the results to be finalized on election night, due to the unprecedented nature of this election. As they shared, it’s more important to get the “right” answer, than rush to an answer that night.
Important decisions that hang in the balance include the potential for a filibuster rule change, a possible reengineering of the Affordable Care Act and the Supreme Court battle. But the mandate is clear for whomever becomes president: while it will be a challenge, it is critical for the president to bring the country together. And Josh and Andrew themselves demonstrated how it’s done—showing the utmost political civility during their presentation.
FDA’s Center for Devices and Radiological Health (CDRH) learns valuable lessons from pandemic
As with every agency, the CDRH made the pandemic its top priority, with more than half the center involved in COVID-19-related support. That included proactively using its emergency use authorization (EUA) and developing templates with recommendations for how to validate diagnostic tests. They also provided greater regulatory flexibility through a variety of policies in 23 guidance documents and 10 EUA templates to allow manufacturers of products already on the market to make low-risk modifications without going back to the FDA. In addition, they held 39 webinars, received over 330,000 inquiries for the 1-800-HOTLINE email boxes and responded with almost 14 million emails.
They also brought together the offices for compliance, pre-market review and post-market surveillance into a single office—the Office of Product Evaluation and Quality—thus moving from siloed offices to integrated teams, which will promote faster, more efficient and better- informed decisions. In addition, they created a “smart template” for reviewers and to make it easier to put a submission together, among other developments.
He concluded by sharing three lessons learned during COVID-19 that the center can apply to their day-to-day work: the value of being able to use emergency use authorization authorities for more regulatory flexibility, the importance of increased engagement and the benefits of a total product lifecycle approach.
As Mark Leahey said as he closed out the Forum, “We really appreciate the commitment that all of you have to advancing innovation patient care. While these are challenging times, we’ll get through this.”