Q&A with Mark Leahey, MDMA CEO and Fogarty Institute Board Member

As the Medical Device Manufacturers Association (MDMA) continues to take the lead in representing the interest of medtech companies, we wanted to sit down and talk with president and CEO, and Fogarty Institute board member, Mark Leahey, about the current landscape. MDMA is an incredibly nimble and effective organization – just like its constituents – and has been a beacon during the COVID-19 crisis, working closely with the members of Congress, the White House, the FDA and other key stakeholders to represent the needs of its members. The organization is also taking a strong stand on increasing diversity in our industry.

Mark has spearheaded MDMA since 2001, growing the organization from 80 to nearly 300 member companies, including many of the most innovative, research-driven medtech startups in the nation. Throughout these years, he has worked relentlessly to advance the healthcare industry.

Read on for the Q&A with Mark that captures his thoughts on the latest developments in our nation, MDMA’s recent virtual annual meeting and what the organization is doing to address COVID-19.

Q. What are MDMA’s views and efforts towards racial diversity in our industry?

A. While the world continues to confront the damage and pain inflicted by the COVID-19 pandemic, especially the disproportionate impact on minority communities, our nation is also being reminded of the pain caused by an ongoing legacy of racism and racial disparities. The images that we have all seen on television, and that many of us are experiencing in our neighborhoods, are a powerful call to the United States to confront the inequalities caused by hatred, divisiveness, and intolerance.

We are all horrified by the tragic death of George Floyd, and our hearts go out to his family, his loved ones, and all those who have suffered at the hands of violence.

NO American should ever have to confront the ugly face of racism, while EVERY American should be permitted to peaceably and passionately protest, to have their voice heard, and their First Amendment rights protected.

Medical technology innovation is built on the successes of the past, and a desire to fix and improve what is not working in the health care delivery system and patient care. We must all be equally committed to make the United States a stronger, more compassionate, more inclusive and more just nation, while confronting the mistakes of our collective past, and working together to make the changes needed to provide a safe and equitable community for all Americans.

We can do better, and we must do better.

We have never been more proud to be a part of our amazing ecosystem as we confront the COVID-19 pandemic and work with the tremendous men and women in our industry who commit themselves to the passionate mission of improving patient care, saving lives and improving the quality of life. We know that we will also help to confront the systemic crisis of racial inequality and work together to make the United States a more fair and tolerant place.

Q. What are the key takeaways from the MDMA annual meeting?

A. Due to the challenging times that everyone is facing, MDMA hosted our first ever “virtual” annual meeting to accommodate our attendees and speakers, and it was a great success. During the meeting we heard from Jeff Shuren, MD, JD, director of the Center for Devices and Radiological Health (CDRH); three members of Congress; Adam Boehler, White House COVID-19 Task Force Advisor; and Stephen Hahn, FDA Commissioner. Commissioner Hahn and Director Shuren updated attendees on what the FDA is doing at this time to address the COVID-19 crisis, while still continuing to approve life-changing medical devices.

The annual meeting consisted of four hours of productive and interactive conversation with top policy makers directly answering our members’ questions. During this time of uncertainty due to the pandemic, speakers provided clarity on the path going forward for the health care system, our economy and the nation. Dr. Shuren provided an overview of the tremendous collaboration between innovators and regulators to enhance patient care. With each member of Congress, MDMA addressed the need to accelerate patient access to deferred procedures, provide liquidity to companies impacted and urged them to continue working in a bipartisan manner to address the pandemic. Policy makers praised our industry for powering through and ramping up production of many supplies needed to address COVID-19.

It was a unique opportunity for our members and attendees to share their concerns directly with policy makers, and it was clear from their remarks that it is critical our industry continues to share our insights and policy proposals as everyone works to confront the current pandemic.

Q. What were some of the key initiatives undertaken by MDMA to help medtech companies during COVID-19?

A. MDMA continues to be engaged on many fronts with members of Congress, the administration and various states to address the numerous issues confronting our members caused by the COVID-19 pandemic. Starting in March, we have been holding a weekly member-wide webinar to hear directly from them on the mission-critical issues they are seeing on the ground, and share the latest from policy makers and regulators in DC.

For example, in late March, MDMA worked closely with the administration and governors to ensure that medical technology companies, including partners in the supply chain, were deemed “essential” and could continue to work as states implemented stay-at-home orders. Once these issues were addressed, MDMA was very active in highlighting the critical need to restore “elective” procedures for patients as soon as possible. In mid-April, the Centers for Medicare & Medicaid Services (CMS) updated its guidance to provide a path forward for these procedures.

Given the significant drop in procedure volume, many MDMA members saw revenues drop dramatically and we worked with Congress to establish liquidity programs, such as the Paycheck Protection Program (PPP). Unfortunately, shifting Treasury Department guidance and public scrutiny of some larger companies accessing PPP made this a less-attractive option than Congress intended. As a result, MDMA established a Liquidity Working Group to explore ways to leverage the tax code to provide more capital for medical technology innovators. Currently, we are working with the National Venture Capital Association (NVCA) on proposals to leverage “net operating losses” (NOL) and R&D tax credits into refundable and advanceable tax credits to provide critical liquidity.

In addition, we created a survey to quantify those discussions and share them with Congress and policymakers.

MDMA has also provided numerous comments that have been shared directly with the administration and others about the concerns we had related to the PPP and the proposed Main Street Lending Program, where we were able to secure some improvements to the regulations. We continue to have productive discussions, and while much more needs to be done, we remain committed to being the voice of our industry on these matters.

We also continue to work closely with medical societies and other stakeholders on ways to reasonably and appropriately ramp up “elective” surgeries. A current challenge is the wide variations in healthcare facility policies related to medical device representatives’ access. While the Association of periOperative Registered Nurses (AORN) issues helpful guidance, MDMA has engaged leading healthcare facilities to translate the guidance into reasonable and executable policies that can be implemented. MDMA remains actively engaged with our Reimbursement Working Group to discuss the “roadmap” we are developing for policy makers and other ideas our industry can work towards as we all address the COVID-19 pandemic and its impact on patient care and our ecosystem.

Lastly, as MDMA works with our member companies to navigate the “new normal” under COVID-19, we have received increasing requests to benchmark and share best practices related to “return to work/office” efforts. While our industry is deemed “essential” by the guidelines issued by the Department of Homeland Security and the states, we know that many companies are implementing new operational structures and policies to manage employees’ physical return to work. We are working very closely with our members’ legal, HR and executive teams to address these challenges under our new MDMA “Return to Work” working group.

Countless issues are arising as the nation begins to reopen, and while it is certainly daunting at times, our collective efforts have resulted in concrete improvements on numerous policies and regulations that are impacting the medical technology ecosystem.

Q. What are the latest developments in MDMA’s efforts to work with CMS to speed up the process between FDA clearance and reimbursement?

A. Narrowing the gap between the regulatory and reimbursement decisions for innovative technologies remains a top priority for MDMA, and we continue to focus on working directly with the U.S. Department of Health and Human Services (HHS), CMS, Congress and private payors to advance much-needed changes to the processes. While confronting the COVID-19 pandemic has certainly become the top priority, the work to close the gap between the FDA processes and reimbursement goes on.

As you may know, starting last year, CMS initiated numerous reforms to enhance the Healthcare Common Procedure Coding System (HCPCS) coding process and to require more transparency from local Medicare administrative contractors (MACs) regarding coverage decisions, especially omnibus non-coverage policies for technologies with Category III codes. While these reforms are welcomed, more must be done to allow for faster coverage for innovative medical technologies. MDMA has been advocating for transitional coverage for innovative medical technologies for many years, and we were encouraged that the administration continues to work on a proposed rule that would accelerate coverage. In addition, the Office of Management and Budget (OMB) has had a proposed rule under review for nearly a year, and we are hopeful this will be released for public comment this summer.

Beyond our work with CMS, MDMA remains actively engaged with our members and private payers to explore ways to make the coverage process more transparent and predictable. This included developing a “best practices” document that incorporates elements recognized globally to generate and review evidence for the purpose of coverage decisions.

MDMA remains committed to working with HHS, CMS, Congress and all stakeholders to help improve the reimbursement landscape so that patients throughout the U.S. get timely access to medical technology innovation.

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