Sean Fenske, Editor-in-Chief03.04.21
The medical device industry is often identified by the silo in which it functions. For example, cardiovascular devices, surgical tools and instrumentation, orthopedic implants, and many others. With such a segmented landscape, it can often be difficult to coordinate efforts to benefit all the sectors. Fortunately, the medical device manufacturing industry has two such associations that try to put the best foot of the entire industry forward and bring awareness to issues affecting us all.
As such, MPO took time to speak with the leaders of each organization. Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), and Scott Whitaker, president and CEO of AdvaMed, took time to address a number of concerns and issues on the minds of many in the medtech community. With a new administration in the White House, a Congress under new party control, and an array of potential changes coming, it seemed like a perfect time to catch up with these two pillars of the community to get their feedback.
[Note: These interviews took place in February 2021 and may not address recent action by the President, Congress, or any other actions that could have occurred after they were conducted.]
Sean Fenske: With a new administration (and political party) coming into the White House, what are some of the priorities you would expect will impact medtech?
Mark Leahey: The top priorities for Congress and the Biden Administration are, of course, to continue confronting the COVID-19 pandemic, and medical technology innovators remain committed to helping them in this critical work. As you know, when this pandemic first arose, our dynamic industry rose to the challenge by developing innovative diagnostics, monitoring devices, ventilators, PPE, and much more. This has truly been an “all hands on deck” approach, and there is more work to be done. President Biden has been a strong supporter of the innovation ecosystem, and was one of the leaders in developing the “CURES Act” during the Obama Administration, which resulted in new policies to support the development of innovative cures and therapies. His support of the “Cancer Moonshot” and other initiatives show his appreciation of our industry and the life sciences community, and we look forward to working with him and the new Congress to continue this important journey.
Scott Whitaker: Without question, the top priority of our industry, the Biden administration, and Congress has been and will continue to be winning the fight against COVID-19. Our industry ramped-up practically overnight to 24/7 operations to ensure patients and frontline healthcare workers would have the PPE, ventilators, tests, and vaccine supplies necessary to meet the demands of the crisis. We reached out early to our federal and state government partners to ensure the best and most efficient distribution of these much-needed medical products, and that work has continued seamlessly with the new administration. Also, with MDUFA V (which refers to the user-fee arrangement our industry has with FDA to fund the device review process) coming up, we’ll be working to ensure the process remains consistent, predictable, and efficient.
Fenske: With Biden having served as VP to President Obama, do you expect an emphasis on Obamacare?
Whitaker: President Biden campaigned on the expansion of the Affordable Care Act to cover more patients in need. Clearly, we support expanding patient access to life-saving care, but the key question always is: What is the best federal policy or set of policies to achieve that? We look forward to working with the administration to answer that important question.
The expansion of access to and affordability of health care to as many Americans as possible is one of our primary goals as an industry. Our No. 1 priority is the patients we serve, so we look forward to working with the Biden administration and Congress on the policies best suited to achieve that mutually shared goal.
Fenske: What have been your thoughts on President Biden based on his short time in office?
Leahey: President Biden took numerous steps to assess the legislative activities of the previous administration immediately following his inauguration. White House Chief of Staff Ron Klain issued a memorandum to heads of executive departments and agencies ordering a freeze on all rules currently pending until the administration has the opportunity to review all new or pending regulations. These regulatory pauses are a common practice when a new administration begins. MDMA is working with Congress and the Biden Administration to move forward with the implementation of the MCIT final rule, which provides accelerated coverage for FDA designated “breakthrough” devices. This policy has bipartisan support in Congress, and is also supported by the career staff at the Centers for Medicare and Medicaid Services.
In addition, President Biden issued several executive orders (EOs) to confront the COVID-19 pandemic, and various other issues on his first day in office. These are the first of what is expected to be a series of steps that include reversing numerous Trump administration policies. Notably, President Biden signed an EO that requires relevant federal agencies to take an immediate inventory of pandemic response supplies, review the market’s ability to meet demand, identify gaps in available supply, and recommend use of the Defense Protection Act (DPA) to address them. The EO requires the same agencies in coordination with the COVID-19 Response Coordinator to develop a strategy “to design, build, and sustain a long-term capability in the United States to manufacture supplies for future pandemics and biological threats.”
MDMA is working closely with the new administration on issues that would impact our industry, and to help ensure that policies that have broad, bipartisan support are not reversed.
Fenske: Speaking of executive orders, can you speak to the one President Biden issued designed to bolster U.S. manufacturing?
Leahey: Earlier this year, President Biden issued an Executive Order (EO) “Ensuring the Future Is Made in All of America by All of America’s Workers.” The order aims to boost American manufacturing and directs agencies to address loopholes in how domestic content is measured by raising the domestic content threshold and price preferences.
Additionally, the order appoints a new position within the Office of Management and Budget (OMB) to oversee implementation. The order increases oversight of potential waivers to domestic preference laws through the creation of a central review of agency waivers of “Buy American” requirements. This EO instructs agencies to utilize the Manufacturing Extension Partnership, which is a nationwide network that supports small and medium-size manufacturers, to help agencies connect with new domestic suppliers who can make the products they need while employing America’s workers.
This order is one of several steps the Biden Administration is expected to take to strengthen domestic supply chains and modernize international trade regulations. MDMA agrees with President Biden that the United States’ manufacturing sector needs to be robust, and we are committed to help ensure that our nation remains the global leader in medical device innovation. It is also critical to ensure that nothing is done to adversely impact the global supply of critical medical products during the public health emergency.
Fenske: Beyond executive orders, with Democrats also in control of Congress, what parts of the legislative agenda could impact medical device firms?
Whitaker: Right now, it’s too early in the current congressional session to tell. It’s wait and see. But we are ready to respond to a number of issues we anticipate might see some movement, like the VALID Act. With all eyes on diagnostic testing, we think the VALID Act has a good chance of making it through Congress this year. The bipartisan legislation would establish a single predictable regulatory framework tailored to all clinical diagnostic tests. It’s been an AdvaMed priority for a long time.
Fenske: What’s happening with regard to the effort to collect more post-market surveillance data? How could this impact regulatory submissions?
Whitaker: One important MDUFA IV commitment was that FDA would permit the use of real-world evidence as part of the data requirements necessary for a regulatory submission by a medical device company. In other words, FDA would accept real-world evidence data in a premarket regulatory submission. It gives manufacturers more to work with. So, ideally, we could see devices get on the market more quickly, and thus, to patients more quickly, which is always the goal.
Fenske: Dr. Shuren has said they’d like to have 50 percent of all novel medical devices come out in the U.S. first (or at least in parallel). Why is this effort important?
Whitaker: Dr. Shuren is exactly right to have as a goal to provide American patients access to innovative medical technology as soon as possible, and we appreciate his leadership on this front. We strongly support his goal. As we have said often, advances in medical technologies and diagnostics enhance and extend lives. Matter of fact, over the past 30 years, medical advancements have extended U.S. life expectancy by at least five years. That’s incredible progress in such a short period of time, and we at AdvaMed are supportive of policies that increase our industry’s ability to improve and save patients’ lives.
Fenske: Do you anticipate the introduction of the MDR in the EU will help make this goal easier to achieve?
Whitaker: The medical technology industry supported the much-needed improvements in the EU’s regulatory system—including more consistency across Europe in the expertise of the “notified bodies” and additional clinical requirements. However, we have repeatedly expressed our concerns to EU officials since May 2017 (which was when the MDR began its implementation process) that the EU’s regulatory system would not be completely ready by May 2020. Fortunately, the EU finally extended that deadline to May 2021.
We still see implementation problems, including the lack of sufficient capacity in these notified bodies to evaluate the many medical devices in the EU and missing documents to guide medical device companies in completing the conformity assessment process, which is there to ensure products are safe, perform as intended, and are consistent with the new regulations. Large companies can probably navigate through these problems, but smaller ones are likely to encounter major difficulties—such as finding a notified body and the substantially higher cost of completing the MDR’s regulatory process.
Because so much innovation comes from small companies, the EU might fall behind in developing new and innovative products.
Fenske: Another aspect that could help to bolster that effort is the CMS final rule to expedite coverage of innovative technologies. Can you speak to that factor in this effort?
Leahey: Earlier this year, the Centers for Medicare and Medicaid Services (CMS) released the “Medicare Coverage of Innovative Technology (MCIT)” final rule that will expedite patient access to innovative medical technologies. This was the result of a long journey that MDMA has been involved in for six years, and it is a policy that also has strong bipartisan support from Congress as well.
The MCIT pathway provides four years of national Medicare coverage for all medical devices with FDA’s “breakthrough” designation starting on the date of FDA market authorization. The coverage allows these devices four years to build evidence of their value, after which CMS will evaluate the devices based on clinical and real-world evidence of improvement in health outcomes among Medicare beneficiaries before establishing permanent coverage. Additionally, device manufacturers are given the flexibility to decide when they would like for coverage to start to better align with their manufacturing and distribution cycles.
CMS’ final rule to accelerate coverage for breakthrough technologies will allow our nation’s seniors to benefit from innovative solutions to their healthcare needs. MDMA continues to advocate for updated coverage policies that would allow innovative therapies and technologies to get into the hands of patients and physicians in an expedited manner, and the MCIT final rule is a major step towards achieving this goal.
We were pleased that CMS acknowledged much of the feedback that we shared in our comments to the proposed rule, which was created with the input from numerous MDMA members. As always, we will continue to work with CMS and other stakeholders to improve the environment for coding, coverage, and payment, and do so driven by the collective input of our members. Again, we will be working very closely with the Biden Administration to help ensure this final rule is implemented as soon as possible.
Fenske: Another priority from CDRH is a new system that enables the tracking of submissions. Is this a welcome addition for communication with the agency?
Whitaker: Establishment of the “submission tracker” is a MDUFA IV commitment and we welcome the program. The system will enable a submitter to track the status of their submission throughout the review process. Think of it like the pizza tracker when you order delivery: a device manufacturer knows exactly which stage their submission is at and where it’s headed next. And maybe more than just awareness, it will facilitate better collaboration between FDA and device manufacturers.
Fenske: What’s the intent or purpose of the FDA forming a “Digital Center of Excellence”?
Whitaker: FDA’s Digital Health Center of Excellence will further move the agency toward a consistent approach to the regulatory oversight of digital health tools and technologies, not just within CDRH but across the entire FDA. AdvaMed, and its Center for Digital Health, supports FDA’s commitment to ensuring that safe and effective digital health products are available to patients in a timely and predictable manner. FDA’s Digital Health Center of Excellence will support this objective by establishing a strong, centralized coordinating structure, and provide FDA and stakeholders with access to specialized experts and tools during the review process.
Fenske: What other priorities have been outlined by the CDRH in the past that you anticipate being put into the spotlight in 2021?
Whitaker: One initiative that CDRH introduced is the voluntary safety-and-performance pathway for a 510(k) submission. Think of it like a cookbook approach: FDA considers a well-known device type and develops product-specific guidance that specifies in great detail the types of data and criteria that are necessary for approval. It gives manufacturers better clarity—they know exactly what needs to be in their submission. And so, it should streamline and quicken the path to market, which means patients ultimately benefit.
Fenske: Have there been lessons learned during the pandemic that could be implemented going forward that would represent an improvement?
Whitaker: AdvaMed responded to HHS for a request for information regarding pandemic policies that should remain in effect post-pandemic. (This is a public document since it was a response to a docket.) There are a few things we’d like to see stick around:
CMS waived a slew of statutory and regulatory requirements that limit patients’ access to telehealth—they also relaxed certain coverage criteria for services that would usually require in-person visits to a physician’s office, so they can now be conducted via telehealth. We know telehealth is here to stay even after the pandemic is over. And patients should be able to communicate with their doctors via telehealth, regardless of where they live or what kind of technologies they’re using. In that vein, similarly, we’d welcome a study into the current Hospitals-without-Walls program, so we can better understand if it should be made permanent. That program allows ASCs and other non-hospital settings to serve as hospitals for patients in need.
The pandemic highlighted the need for better alignment within our healthcare system. To move toward that goal, we need to modernize the AKS [Anti-Kickback Statute]. We need to remove outdated barriers to collaboration. We need to encourage value-based arrangements that would free innovation and foster a more coordinated response to patient care.
It’s crucial we don’t lose the progress we’ve made during the pandemic. That means, for example, we need to keep coverage structures for COVID-19 diagnostic testing in place. And we need FDA to make sure that devices that received an EUA from FDA have a clear, smooth transition to clearance or approval.
Fenske: Before we wrap, do you have any other thoughts or comments you’d like to share?
Leahey: MDMA has a proud history of grassroots engagement, and we are encouraging medical technology innovators to introduce yourselves to your members of Congress over the coming weeks for a “virtual” meeting and/or possible visit to your offices to learn about the innovations you and your team are working on.
With over 60 new members of Congress and countless new administration officials leading various federal agencies that will drive health policy, now is the time to reach out. While the ongoing challenges and restrictions presented by the COVID-19 pandemic make it difficult for in-person events, it is all the more critical that our industry continues to build relationships with Congress as they embark on a very busy legislative year.
Whether it was a repeal of the medical device tax or numerous other legislative milestones that the medical technology industry has achieved, they were driven by our collective grassroots activities. We strongly encourage medical technology innovators to get involved and share the powerful stories of the lifesaving and life-changing cures and therapies you are working on.
As such, MPO took time to speak with the leaders of each organization. Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), and Scott Whitaker, president and CEO of AdvaMed, took time to address a number of concerns and issues on the minds of many in the medtech community. With a new administration in the White House, a Congress under new party control, and an array of potential changes coming, it seemed like a perfect time to catch up with these two pillars of the community to get their feedback.
[Note: These interviews took place in February 2021 and may not address recent action by the President, Congress, or any other actions that could have occurred after they were conducted.]
Sean Fenske: With a new administration (and political party) coming into the White House, what are some of the priorities you would expect will impact medtech?
Mark Leahey: The top priorities for Congress and the Biden Administration are, of course, to continue confronting the COVID-19 pandemic, and medical technology innovators remain committed to helping them in this critical work. As you know, when this pandemic first arose, our dynamic industry rose to the challenge by developing innovative diagnostics, monitoring devices, ventilators, PPE, and much more. This has truly been an “all hands on deck” approach, and there is more work to be done. President Biden has been a strong supporter of the innovation ecosystem, and was one of the leaders in developing the “CURES Act” during the Obama Administration, which resulted in new policies to support the development of innovative cures and therapies. His support of the “Cancer Moonshot” and other initiatives show his appreciation of our industry and the life sciences community, and we look forward to working with him and the new Congress to continue this important journey.
Scott Whitaker: Without question, the top priority of our industry, the Biden administration, and Congress has been and will continue to be winning the fight against COVID-19. Our industry ramped-up practically overnight to 24/7 operations to ensure patients and frontline healthcare workers would have the PPE, ventilators, tests, and vaccine supplies necessary to meet the demands of the crisis. We reached out early to our federal and state government partners to ensure the best and most efficient distribution of these much-needed medical products, and that work has continued seamlessly with the new administration. Also, with MDUFA V (which refers to the user-fee arrangement our industry has with FDA to fund the device review process) coming up, we’ll be working to ensure the process remains consistent, predictable, and efficient.
Fenske: With Biden having served as VP to President Obama, do you expect an emphasis on Obamacare?
Whitaker: President Biden campaigned on the expansion of the Affordable Care Act to cover more patients in need. Clearly, we support expanding patient access to life-saving care, but the key question always is: What is the best federal policy or set of policies to achieve that? We look forward to working with the administration to answer that important question.
The expansion of access to and affordability of health care to as many Americans as possible is one of our primary goals as an industry. Our No. 1 priority is the patients we serve, so we look forward to working with the Biden administration and Congress on the policies best suited to achieve that mutually shared goal.
Fenske: What have been your thoughts on President Biden based on his short time in office?
Leahey: President Biden took numerous steps to assess the legislative activities of the previous administration immediately following his inauguration. White House Chief of Staff Ron Klain issued a memorandum to heads of executive departments and agencies ordering a freeze on all rules currently pending until the administration has the opportunity to review all new or pending regulations. These regulatory pauses are a common practice when a new administration begins. MDMA is working with Congress and the Biden Administration to move forward with the implementation of the MCIT final rule, which provides accelerated coverage for FDA designated “breakthrough” devices. This policy has bipartisan support in Congress, and is also supported by the career staff at the Centers for Medicare and Medicaid Services.
In addition, President Biden issued several executive orders (EOs) to confront the COVID-19 pandemic, and various other issues on his first day in office. These are the first of what is expected to be a series of steps that include reversing numerous Trump administration policies. Notably, President Biden signed an EO that requires relevant federal agencies to take an immediate inventory of pandemic response supplies, review the market’s ability to meet demand, identify gaps in available supply, and recommend use of the Defense Protection Act (DPA) to address them. The EO requires the same agencies in coordination with the COVID-19 Response Coordinator to develop a strategy “to design, build, and sustain a long-term capability in the United States to manufacture supplies for future pandemics and biological threats.”
MDMA is working closely with the new administration on issues that would impact our industry, and to help ensure that policies that have broad, bipartisan support are not reversed.
Fenske: Speaking of executive orders, can you speak to the one President Biden issued designed to bolster U.S. manufacturing?
Leahey: Earlier this year, President Biden issued an Executive Order (EO) “Ensuring the Future Is Made in All of America by All of America’s Workers.” The order aims to boost American manufacturing and directs agencies to address loopholes in how domestic content is measured by raising the domestic content threshold and price preferences.
Additionally, the order appoints a new position within the Office of Management and Budget (OMB) to oversee implementation. The order increases oversight of potential waivers to domestic preference laws through the creation of a central review of agency waivers of “Buy American” requirements. This EO instructs agencies to utilize the Manufacturing Extension Partnership, which is a nationwide network that supports small and medium-size manufacturers, to help agencies connect with new domestic suppliers who can make the products they need while employing America’s workers.
This order is one of several steps the Biden Administration is expected to take to strengthen domestic supply chains and modernize international trade regulations. MDMA agrees with President Biden that the United States’ manufacturing sector needs to be robust, and we are committed to help ensure that our nation remains the global leader in medical device innovation. It is also critical to ensure that nothing is done to adversely impact the global supply of critical medical products during the public health emergency.
Fenske: Beyond executive orders, with Democrats also in control of Congress, what parts of the legislative agenda could impact medical device firms?
Whitaker: Right now, it’s too early in the current congressional session to tell. It’s wait and see. But we are ready to respond to a number of issues we anticipate might see some movement, like the VALID Act. With all eyes on diagnostic testing, we think the VALID Act has a good chance of making it through Congress this year. The bipartisan legislation would establish a single predictable regulatory framework tailored to all clinical diagnostic tests. It’s been an AdvaMed priority for a long time.
Fenske: What’s happening with regard to the effort to collect more post-market surveillance data? How could this impact regulatory submissions?
Whitaker: One important MDUFA IV commitment was that FDA would permit the use of real-world evidence as part of the data requirements necessary for a regulatory submission by a medical device company. In other words, FDA would accept real-world evidence data in a premarket regulatory submission. It gives manufacturers more to work with. So, ideally, we could see devices get on the market more quickly, and thus, to patients more quickly, which is always the goal.
Fenske: Dr. Shuren has said they’d like to have 50 percent of all novel medical devices come out in the U.S. first (or at least in parallel). Why is this effort important?
Whitaker: Dr. Shuren is exactly right to have as a goal to provide American patients access to innovative medical technology as soon as possible, and we appreciate his leadership on this front. We strongly support his goal. As we have said often, advances in medical technologies and diagnostics enhance and extend lives. Matter of fact, over the past 30 years, medical advancements have extended U.S. life expectancy by at least five years. That’s incredible progress in such a short period of time, and we at AdvaMed are supportive of policies that increase our industry’s ability to improve and save patients’ lives.
Fenske: Do you anticipate the introduction of the MDR in the EU will help make this goal easier to achieve?
Whitaker: The medical technology industry supported the much-needed improvements in the EU’s regulatory system—including more consistency across Europe in the expertise of the “notified bodies” and additional clinical requirements. However, we have repeatedly expressed our concerns to EU officials since May 2017 (which was when the MDR began its implementation process) that the EU’s regulatory system would not be completely ready by May 2020. Fortunately, the EU finally extended that deadline to May 2021.
We still see implementation problems, including the lack of sufficient capacity in these notified bodies to evaluate the many medical devices in the EU and missing documents to guide medical device companies in completing the conformity assessment process, which is there to ensure products are safe, perform as intended, and are consistent with the new regulations. Large companies can probably navigate through these problems, but smaller ones are likely to encounter major difficulties—such as finding a notified body and the substantially higher cost of completing the MDR’s regulatory process.
Because so much innovation comes from small companies, the EU might fall behind in developing new and innovative products.
Fenske: Another aspect that could help to bolster that effort is the CMS final rule to expedite coverage of innovative technologies. Can you speak to that factor in this effort?
Leahey: Earlier this year, the Centers for Medicare and Medicaid Services (CMS) released the “Medicare Coverage of Innovative Technology (MCIT)” final rule that will expedite patient access to innovative medical technologies. This was the result of a long journey that MDMA has been involved in for six years, and it is a policy that also has strong bipartisan support from Congress as well.
The MCIT pathway provides four years of national Medicare coverage for all medical devices with FDA’s “breakthrough” designation starting on the date of FDA market authorization. The coverage allows these devices four years to build evidence of their value, after which CMS will evaluate the devices based on clinical and real-world evidence of improvement in health outcomes among Medicare beneficiaries before establishing permanent coverage. Additionally, device manufacturers are given the flexibility to decide when they would like for coverage to start to better align with their manufacturing and distribution cycles.
CMS’ final rule to accelerate coverage for breakthrough technologies will allow our nation’s seniors to benefit from innovative solutions to their healthcare needs. MDMA continues to advocate for updated coverage policies that would allow innovative therapies and technologies to get into the hands of patients and physicians in an expedited manner, and the MCIT final rule is a major step towards achieving this goal.
We were pleased that CMS acknowledged much of the feedback that we shared in our comments to the proposed rule, which was created with the input from numerous MDMA members. As always, we will continue to work with CMS and other stakeholders to improve the environment for coding, coverage, and payment, and do so driven by the collective input of our members. Again, we will be working very closely with the Biden Administration to help ensure this final rule is implemented as soon as possible.
Fenske: Another priority from CDRH is a new system that enables the tracking of submissions. Is this a welcome addition for communication with the agency?
Whitaker: Establishment of the “submission tracker” is a MDUFA IV commitment and we welcome the program. The system will enable a submitter to track the status of their submission throughout the review process. Think of it like the pizza tracker when you order delivery: a device manufacturer knows exactly which stage their submission is at and where it’s headed next. And maybe more than just awareness, it will facilitate better collaboration between FDA and device manufacturers.
Fenske: What’s the intent or purpose of the FDA forming a “Digital Center of Excellence”?
Whitaker: FDA’s Digital Health Center of Excellence will further move the agency toward a consistent approach to the regulatory oversight of digital health tools and technologies, not just within CDRH but across the entire FDA. AdvaMed, and its Center for Digital Health, supports FDA’s commitment to ensuring that safe and effective digital health products are available to patients in a timely and predictable manner. FDA’s Digital Health Center of Excellence will support this objective by establishing a strong, centralized coordinating structure, and provide FDA and stakeholders with access to specialized experts and tools during the review process.
Fenske: What other priorities have been outlined by the CDRH in the past that you anticipate being put into the spotlight in 2021?
Whitaker: One initiative that CDRH introduced is the voluntary safety-and-performance pathway for a 510(k) submission. Think of it like a cookbook approach: FDA considers a well-known device type and develops product-specific guidance that specifies in great detail the types of data and criteria that are necessary for approval. It gives manufacturers better clarity—they know exactly what needs to be in their submission. And so, it should streamline and quicken the path to market, which means patients ultimately benefit.
Fenske: Have there been lessons learned during the pandemic that could be implemented going forward that would represent an improvement?
Whitaker: AdvaMed responded to HHS for a request for information regarding pandemic policies that should remain in effect post-pandemic. (This is a public document since it was a response to a docket.) There are a few things we’d like to see stick around:
CMS waived a slew of statutory and regulatory requirements that limit patients’ access to telehealth—they also relaxed certain coverage criteria for services that would usually require in-person visits to a physician’s office, so they can now be conducted via telehealth. We know telehealth is here to stay even after the pandemic is over. And patients should be able to communicate with their doctors via telehealth, regardless of where they live or what kind of technologies they’re using. In that vein, similarly, we’d welcome a study into the current Hospitals-without-Walls program, so we can better understand if it should be made permanent. That program allows ASCs and other non-hospital settings to serve as hospitals for patients in need.
The pandemic highlighted the need for better alignment within our healthcare system. To move toward that goal, we need to modernize the AKS [Anti-Kickback Statute]. We need to remove outdated barriers to collaboration. We need to encourage value-based arrangements that would free innovation and foster a more coordinated response to patient care.
It’s crucial we don’t lose the progress we’ve made during the pandemic. That means, for example, we need to keep coverage structures for COVID-19 diagnostic testing in place. And we need FDA to make sure that devices that received an EUA from FDA have a clear, smooth transition to clearance or approval.
Fenske: Before we wrap, do you have any other thoughts or comments you’d like to share?
Leahey: MDMA has a proud history of grassroots engagement, and we are encouraging medical technology innovators to introduce yourselves to your members of Congress over the coming weeks for a “virtual” meeting and/or possible visit to your offices to learn about the innovations you and your team are working on.
With over 60 new members of Congress and countless new administration officials leading various federal agencies that will drive health policy, now is the time to reach out. While the ongoing challenges and restrictions presented by the COVID-19 pandemic make it difficult for in-person events, it is all the more critical that our industry continues to build relationships with Congress as they embark on a very busy legislative year.
Whether it was a repeal of the medical device tax or numerous other legislative milestones that the medical technology industry has achieved, they were driven by our collective grassroots activities. We strongly encourage medical technology innovators to get involved and share the powerful stories of the lifesaving and life-changing cures and therapies you are working on.