WASHINGTON – Today, AdvaMed released a statement in support of the bipartisan PREVENT DIABETES Act, which was marked up today in the House Energy and Commerce Health Subcommittee. The legislation, introduced by Reps. Diana DeGette (D-CO), Gus Bilirakis (R-FL), and Jason Crow (D-CO). It was also introduced in the U.S. Senate by Senators Mark Warner (D-VA) and Tim Scott (R-SC).

The Promoting Responsible and Effective Virtual Experiences through Novel Technology to Deliver Improved Access and Better Engagement with Tested and Evidence-based Strategies (PREVENT DIABETES) Act, would make virtual care a permanent option for the Medicare Diabetes Prevention Program.

“Medical technology has been at the forefront of diabetes management and treatment for decades, and rapid innovation by our members now enables patients to better detect prediabetes and prevent the onset of Type 2,” said Scott Whitaker, AdvaMed President and CEO. “It is critical that these life-changing and lifesaving medical technologies are available to patients in even the most remote communities. Telehealth is an essential tool in our fight against this condition, not to mention countless others, which is why we support the bipartisan PREVENT DIABETES Act to ensure rural Medicare beneficiaries who rely on virtual care have full access to the Diabetes Prevention Program. We thank Reps. DeGette, Bilirakis, and Crow for introducing this bipartisan House legislation, as well as the Energy and Commerce Health Subcommittee for moving this bipartisan legislation forward.”

Over 38 million Americans have diabetes, and nearly 100 million Americans aged 18 and older have prediabetes. Diabetes was the 8^th leading cause of death in the United States in recent years. This disease costs our country $412.9 billion every year in direct and indirect costs.

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WASHINGTON, D.C. – Today, diabetes was front and center during a Senate HELP Committee hearing, prompting AdvaMed President and CEO Scott Whitaker to release the following statement on the ways life-saving medical technology is critical in diabetes management:

“On behalf of the dozens of medical technology companies who work alongside providers, patients, and families to diagnose and treat diabetes, I want to commend the Committee for its continued interest in diabetes management and saving lives.  

“While it’s important to take a comprehensive look at this disease, its causes, and risk factors created by it, it is equally important to recognize the existing, proven solutions that are helping patients live fuller, healthier lives. Nowhere is that clearer than in the role medical technology has played in improving and saving millions of lives. Diabetes care and treatment has come so far in recent years thanks to the innovation of medtech companies AdvaMed represents. Tests and treatments are becoming less invasive and easier to use, putting power into the hands of people living with the disease and enabling them to manage their health directly. There are no more one-size-fits-all treatments for diabetes, and that is due largely to medtech. There is simply no diabetes care of any kind without medtech.

“I join the vast majority of Americans in supporting a stronger federal focus on finding better treatments for diabetes, and AdvaMed stands ready to work with our partners to achieve this goal.”

AdvaMed members are at the forefront of innovation in diabetes treatment and care, including:

• Needles and syringes
• Continuous Glucose Monitors
• Blood Glucose Monitors
• Insulin Pump and Automatic Insulin Delivery Systems
• Software and mobile apps
• A1c analyzers for laboratory and point of care

In a national poll conducted by Morning Consult on behalf AdvaMed earlier this year:

• 91% of adults say it should be a priority for the government to invest in research to treat and cure diabetes, including 65% who say it should be a top or important priority.
• Four-in-five adults (87% ) say medical technology plays a significant role in diabetes management.
• Half of adults say they have been screened for prediabetes before.
• Three-in-five adults (60%) say it is difficult for someone to manage their diabetes diagnosis.
• Of those adults who have been diagnosed with diabetes, 73% say it is difficult to manage their diagnosis.

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Medicare is the single biggest health care insurer in the United States. When Medicare covers products or services, millions of Americans benefit. 

Unfortunately, because Medicare is so big, the coverage policies are so complex, and medical technology evolves so fast, coverage often lags behind what’s available on the market. The gaps mean Medicare beneficiaries often have to wait for access to technology that would improve their health. Private insurers tend to follow Medicare’s lead, so the lag times ripple throughout the health care system. 

Diabetes technology is among what’s caught in the gap. This is a major challenge.

As many as one-third of the 66 million Medicare beneficiaries have diabetes.

Medicare enrollment and diabetes diagnoses are projected to grow as the Baby Boom generation ages into Medicare. Baby Boomers will live longer than the previous generation, smoking much less, for example, but with higher diabetes rates. 

Medicare tries to keep up with technology and demands but accomplishes only so much.  

For example, although continuous glucose monitors entered the marketplace in the mid-2000s and patients used them extensively, Medicare didn’t cover the devices until 2017, despite strong evidence supporting coverage. Even now, the coverage policy doesn’t fully address the way patients use the technology on their smart phones. 

Another example is the automated insulin delivery system. 

The FDA approved this technology and defined it as having three components: a continuous glucose monitor, an insulin pump, and a digital algorithm. The algorithm allows the monitor and insulin pump to talk to each other and automatically adjust the patient’s glucose levels. Medicare now covers and pays for each of the first two components as durable medical equipment, but regulations don’t say how the algorithm could be covered and paid for separately.  

Medicare should cover the algorithm as a supply necessary for the functioning of the technologies that do qualify for coverage, the same way Medicare covers test strips used with blood glucose monitors and oxygen used in canisters.  

The medtech industry is working with federal agencies and Congress to close these gaps. There’s a lot of work to do. The Centers for Medicare and Medicaid Services’ Transitional Coverage for Emerging Technologies (TCET) notice is a step in this direction, but it should be much stronger to ensure a predictable pathway to national Medicare coverage for new medical devices and diagnostics, including diabetes technology. 

Patients tell us all the time how the latest technology to monitor and manage diabetes is life-changing for them. I see that myself as the father of a daughter with Type 1 diabetes. As we recognize National Diabetes Month, I urge faster coverage of diabetes medtech for the millions of Medicare beneficiaries who deserve their best quality of life today, not tomorrow.  

For more, please see these resources:

• AdvaMed’s formal comments on the Centers for Medicare and Medicaid Services (CMS) Transitional Coverage for Emerging Technologies Notice 

• AdvaMed Center for Digital Health/CapView Strategies report, “Modernizing Medicare Coverage of Digital Health Technologies”  

The post Medicare and Diabetes Technology Coverage: Closing the Gaps appeared first on AdvaMed.

Diabetes

National Diabetes Month 2024

This November, AdvaMed is partnering with member companies to raise awareness and highlight medtech’s role in helping patients manage their diabetes and live fuller and better lives.

Diabetes

Medtech’s Role in Improving Diabetes Care

November is National Diabetes Awareness Month, a time to shine a spotlight on one of the most prevalent and pressing health issues of our time: diabetes. This month serves as a critical reminder of the importance of understanding, preventing, and managing diabetes, which affects millions of Americans and their families. Through education, advocacy, and community support, Advamed, our member companies, and our partners aim to raise awareness about diabetes, its risk factors, and the steps individuals can take to live healthier, more fulfilling lives.

Join us in this month-long campaign, #BeatDiabetes, to make a positive impact and promote a brighter, healthier future for all those affected by diabetes.

AdvaMed Members and Partners Recognize National Diabetes Month

Diabetes Patient Stories

Patient

Married by Medtech: Natalie’s and James’ Story

Chronic illness hasn’t stopped Natalie and James from pursuing their fairytale, and medtech has ensured as smooth a pursuit as possible.

Patient

Living Fearlessly in the Face of Diabetes

Hannah’s journey with type one diabetes started when she was ten years old. Now she uses a continuous glucose monitoring system, which records blood sugar levels constantly.

The post National Diabetes Month 2024 appeared first on AdvaMed.

Diabetes is a serious health problem in the United States and worldwide. The consequences of unchecked diabetes are dire. 

But there’s good news to celebrate during National Diabetes Month and on World Diabetes Day November 14. 

The technology to monitor and manage diabetes has evolved rapidly in recent years, dramatically changing the quality of life for patients. 

Only a few years ago, parents of children with diabetes had to wake up their kids every two hours to check their insulin levels, with constant finger pricks and injections. Now, many of those kids can use a continuous glucose monitor and an iPhone app – no more constant finger pricks and injections.  

Continuous glucose monitors are the size of only two stacked pennies. Diabetes management is much easier than ever before. 

At the same time, inequitable access to the best diabetes products is a problem. Coverage policies, whether in government programs or in private insurance, should ensure broad access to the latest diabetes technology and the continuum of care to ensure the strongest possible patient outcomes.  

Patients need not only the technology, which is key, but also information on how to use it, good nutrition, and access to the ophthalmologists, cardiologists, endocrinologists, and podiatrists who can prevent and treat the worst outcomes of poorly managed diabetes. 

This month, let’s take a step forward in our own circles of influence to help someone get screened, promote access to health care covering diabetes management and treatment, and advance policies to increase access to the latest medtech enabling a good quality of life for those with diabetes.  

Eventually, medtech innovation may contribute to a cure. Thank you to the innovators working hard to create the breakthrough technology advancing diabetes care to the futuristic level we experience today. I can’t wait to see what’s next. 

On a personal note, my wife, Michelle, and I just spent a wonderful evening with friends, family, and colleagues at the JDRF Mid-Atlantic Chapter Gala as we celebrated the courage and resilience of those living with Type One Diabetes, especially our daughter, Eva. While we continue to search for a cure, we are grateful for all the medtech community has done to innovate and transform the management for this disease. 

Resources

For policymakers, please see more about medtech’s role in managing diabetes, including a downloadable fact sheet and patient stories. 

A Morning Consult poll found an overwhelming number of Americans believe medical technology plays a significant role in treating and improving the health and well-being of those living with diabetes, but those diagnosed with the disease struggle to manage their condition. The poll also found broad, bipartisan support for government investment in researching treatments and cures for diabetes. 

My Medtech POV podcast conversation with Lisa Earnhardt of Abbott Laboratories addresses how innovative technology is helping patients manage diabetes, allowing them to live fuller and better lives. 

For parents and patients, JDRF has resources for children, teens, and adults. 

For health educators, please see the diabetes ABCs resources – A for the A1C blood glucose test, B for blood pressure, C for cholesterol – from the National Institute of Diabetes. 

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WASHINGTON, D.C. –  A new national poll conducted by Morning Consult on behalf of AdvaMed, the medtech association, found that an overwhelming number of Americans believe medical technology plays a significant role in treating and improving the health and wellbeing of those living with diabetes, but those diagnosed with the disease struggle to manage their condition. The poll also found broad, bipartisan support for government investment in researching treatments and cures for diabetes.

“With more than 37 million Americans living with diabetes, expanding access to life-saving medical technologies that will help them better manage their illness is essential. The American people clearly see the tremendous value the medtech industry provides to those with diabetes and their families. There is also strong support for federal policies and investments that drive further innovation and lower costs for patients,” said Scott Whitaker, AdvaMed President and CEO. “America’s medtech companies have led the way to a new era of innovation in diabetes management and care, developing advanced insulin pumps and CGMs that, when paired with connected devices, will one day make the artificial pancreas a reality. Ensuring every patient has access to these life-saving breakthrough technologies is a top priority for AdvaMed and the medtech industry. Clearly, there is strong, bipartisan consensus among Americans that Congress and the Administration must do more to make this a reality.”

“Living with diabetes today is much different than 10 years ago, in large part due to people having more access to new technology. Our innovative CGM technology, for example, is now used by more than 4.5 million people because it’s simple, effective and affordable,” said Jared Watkin, senior vice president for Abbott’s diabetes care business, and chair of AdvaMed’s Diabetes Executive Leadership Group. “We hear every day the vital role technology plays in helping people living with diabetes manage their condition.  That’s why Abbott remains focused on working with AdvaMed, our industry peers, health systems and government agencies to push hard for expanded access.”

The poll, conducted last month by Morning Consult, surveyed 2,200 adults with a margin of error of ±2%. Key findings include:

• Four-in-five adults (87% ) say medical technology plays a significant role in diabetes management.
• 91% of adults say it should be a priority for the government to invest in research to treat and cure diabetes, including 65% who say it should be a top or important priority.
• Half of adults say they have been screened for prediabetes before.
• Three-in-five adults (60%) say it is difficult for someone to manage their diabetes diagnosis.
• Of those adults who have been diagnosed with diabetes, 73% say it is difficult to manage their diagnosis.

According to the CDC, more than 37 million Americans have Type 1 or Type 2 diabetes. The disease can damage the heart, blood vessels, eyes, kidneys, and nerves, increasing the risk of stroke and heart disease, kidney failure, and severe infection. More and more patients are relying on innovative advanced diabetes medical technologies such as  continuous glucose monitors and insulin pumps to manage their disease seamlessly and more effectively to prevent serious adverse effects.

# # #

The post New Poll Shows Americans See Benefit of Medtech in Diabetes Management, Support Government Investment in Research and Cures appeared first on AdvaMed.

Sectors

Diabetes

The sector dedicated to enhancing the care and treatment of individuals with diabetes using the latest methods and technology.

Sectors

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Understanding Diabetes

Type 1 diabetes (T1D) develops when the immune system attacks the cells in the pancreas that make insulin. T1D most commonly develops in children or young adults, and there is no way to prevent or cure T1D. Type 2 diabetes (T2D) occurs when the pancreas cannot create insulin in the proper amount for blood sugar management or when the body may not use the insulin it has correctly. As a result, blood sugar levels increase to unsafe levels.

More than 37 million Americans have diabetes.

5-10% of diagnosed cases have Type 1 diabetes.

90-95% of diagnosed cases have Type 2 diabetes.

When diabetes is not controlled, patients’ high glucose levels can lead to serious health complications and even death. In fact, diabetes is the 7th-leading cause of death in the United States. There are 96 million U.S. adults – more than 1/3 of the population – who are living with prediabetes, and more than 80% of these adults do not know they have it.

How Diabetes Impacts Health

Over time, diabetes can damage the heart, blood vessels, eyes, kidneys, and nerves.

Adults with diabetes have an increased risk (2x-4x) of strokes and heart disease.

Combined with reduced blood flow, nerve damage in the feet increases the chance of foot ulcers, infection, and amputation. In fact, more than 60% of non-traumatic lower-limb amputations are in patients with diabetes.

Diabetic retinopathy is a cause of blindness as a result of long-term accumulated damage to the small blood vessels in the retina.

Diabetes is among the leading causes of kidney failure.

People with diabetes are more likely to have poor outcomes for several infectious diseases, including COVID-19.

Medtech’s Role in Improving Diabetes Care

Early diagnosis and treatment of diabetes can lead to improvements in long-term health outcomes of patients. AdvaMed members are developing new devices and technologies that make day-to-day life healthier and easier for those living with diabetes – and allow patients to manage their diabetes more effectively, improving their care outcomes in the process. These include continuous glucose monitors (CGMs), which automatically track glucose levels day and night, allowing persons with diabetes to see where their glucose values have been, where they are now, and where they are going, with fewer or no finger sticks compared to the older traditional blood glucose monitors.

The most common alternative to CGMs, a method called blood glucose monitoring (BGM), only provides point-in-time data and often misses important high or low blood glucose level episodes. Thanks to advancements in medical technology, CGMs can fill in important data gaps and even alert the patient in real time of a high or low glucose episode so they can immediately bring their glucose back into an optimal range. CGMs generally consist of a sensor/transmitter that is worn on the body to measure glucose data and a reader or smartphone that allows users to view current and past glucose readings.

CGMs are often used with insulin pumps, which are small, computerized devices that deliver insulin in small doses or a bolus dose close to mealtime to control the rise of blood sugar after a meal, mimicking the body’s normal release of insulin.

The next generation of these advanced diabetes technologies will link CGM and insulin pump use together through an algorithm to create an artificial pancreas, so that patients will be able to count on their CGM to let the insulin pump know when insulin is needed. It will be crucial in the near future for private health plans and public programs like Medicare to bring clarity to their coverage and payment policies for technologies like the artificial pancreas.

Diabetes Patient Stories

Patient

Living Fearlessly in the Face of Diabetes

Hannah’s journey with type one diabetes started when she was ten years old. Now she uses a continuous glucose monitoring system, which records blood sugar levels constantly.

Patient

Married by Medtech: Natalie’s and James’ Story

Chronic illness hasn’t stopped Natalie and James from pursuing their fairytale, and medtech has ensured as smooth a pursuit as possible.

The post Diabetes appeared first on AdvaMed.

On May 27, AdvaMed submitted a letter to Medicare Administrative Contractors (MACs), Novitas and First Coast Service Options, regarding proposed local coverage determinations (LCD) entitled “Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcer.” AdvaMed’s input focused on a number of issues within the LCD and the corresponding billing and coding guidelines including the classification of skin substitutes; the general scope of the policy; the limitation of no more than two applications of a skin substitute graft product; and billing and coding guidelines.

For more information on AdvaMed’s efforts around skin substitute products, please contact Tara Burke.

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Medtech POV was excited to welcome Lisa Earnhardt, who leads many of Abbott’s initiatives addressing diabetes. On the podcast, which was recorded during Diabetes Awareness month in November, Earnhardt, who now serves as Executive Vice President of Medical Devices at Abbott, discussed her decades-long career in medtech and vision for the future of innovation.

Addressing Diabetes Care and Inequities

During the interview, Earnhardt described how she and her team are helping patients manage diabetes, which she calls “one of the most pressing healthcare issues of our time.” She continued: “In fact, we probably would have been talking a lot more about it the last two years if we weren’t talking about COVID, in terms of the almost pandemic level impact of the disease, with over 400 million people around the globe suffering from diabetes.”

Thanks to years of research from the medtech industry, those living with diabetes can wear a small device that constantly monitors their glucose level, rather than pricking their fingers several times a day. Along with developing the technology, Abbott is also working with groups like the American Diabetes Association to ensure equitable access to these treatments around the globe. 

How Innovation is Propelling Medtech Forward

As Lisa Earnhardt noted on the podcast, Abbott’s work in diabetes – and all disease areas – is about getting technology to where and when it’s needed. She believes that in many areas this innovation was accelerated by the pandemic. However, when it comes to what she finds most rewarding, she notes: “I’m just proud that we’re able to make a difference.”

Earnhardt’s work in diabetes is just one part of her expansive career in healthcare technology. Prior to joining Abbott, she successfully ran a medical device startup, giving Earnhardt a unique perspective on leadership. 

“Just one member of the team and their capabilities can make a huge difference; making sure you’re surrounding yourself with the team that will not only help serve your needs of today, but ultimately takes you to where you want to need to go.” 

––Lisa Earnhardt, Executive Vice President of Medical Devices, Abbott

During the conversation, Earnhardt shared some of the most important lessons she’s learned as a leader. For those within the medtech industry, Earnhardt stresses the importance of building the right team, or as she put it, “the importance of people.”

To hear Earnhardt’s perspectives on medtech and innovation, listen to the latest episode, and learn more about the Medtech POV podcast.

The post Abbott’s Executive Vice President of Medical Devices Lisa Earnhardt Sits Down with Medtech POV appeared first on AdvaMed.

WASHINGTON, D.C. – Lisa Earnhardt, Executive Vice President, Medical Devices, at Abbott joined AdvaMed’s Scott Whitaker on the Medtech POV podcast to discuss how innovation and technology are helping patients manage diabetes, allowing them to live fuller and better lives. It is an issue that is particularly important to Whitaker, who is the parent of a child with type 1 diabetes.

During the conversation, Earnhardt laid out the stakes of dealing with diabetes on a global level, saying “there’s no question that diabetes is one of the most pressing healthcare issues of our time. In fact, we probably would have been talking a lot more about it the last two years if we weren’t talking about COVID, in terms of the almost pandemic level impact of the disease, with over 400 million people around the globe suffering from diabetes.”

Earnhardt further shared the many ways Abbott is using technology and innovation to help people manage diabetes and other conditions in ways they couldn’t before, telling Whitaker, “I’m just proud that we’re able to make a difference, whether it be in diabetes or what we’ve done with rapid testing for COVID. There’s a lot of areas where we’ve focused squarely on getting the technology to where and when it’s needed.”

She explained that, for a long time, the only way for people with diabetes to test glucose levels was pricking their finger several times a day. Thanks to years of research by the medtech industry, as well as partnerships with groups such as the American Diabetes Association, numerous technological advances are making it easier to live with and manage the disease. Today, people with diabetes can wear a small device that constantly monitors glucose levels and alerts them when they get too high or too low.

Scott, whose daughter has had diabetes for 10 years, applauded Earnhardt and Abbott for their tireless work in ensuring their technology can be broadly accessible and affordable, around the globe, as well as their partnership with the American Diabetes Association’s Health Equity Now initiative which seeks to address health disparities for people with diabetes.

Working on research and development of technology to help treat and manage medical conditions is nothing new to Earnhardt. Prior to joining Abbott, she successfully ran a medical device startup. That experience gave her a different perspective on leadership and success that she carries with her today.

During the conversation, Earnhardt shared some of the most important lessons she learned from that time. Among them, was the value of building the right team, or as she put it, “the importance of people.” Earnhardt went on to explain how “one member of the team and their capabilities can make a huge difference. Making sure you’re surrounding yourself with the team that will not only help serve your needs of today, but ultimately, take you to where you want to go.”

To listen to the full conversation, including how Abbott accelerated innovation to meet the needs of the coronavirus pandemic, download the Medtech POV podcast on Spotify, Apple Podcasts or wherever podcast streaming is available. Visit AdvaMed’s website for more information on the podcast and past guests.

The Medtech POV podcast is hosted by Scott Whitaker, President and CEO of AdvaMed, the world’s largest medical technology association. It premiered in April 2021 and has featured medtech and health care policy leaders such as Dr. Steven Hahn and General James Mattis. In each episode, guests and host Scott Whitaker cover the intersection of medtech and policy from every perspective, including current issues in business, policy and current events.

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AdvaMed member companies produce the medical devices, diagnostic products and digital health technologies that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.

The post Medtech POV Podcast with Scott Whitaker | Abbott’s Lisa Earnhardt Discusses How Technology and Innovation are Making it Easier and More Affordable to Manage Diabetes appeared first on AdvaMed.