Hear from AdvaMed’s data privacy expert, Terry Chang, on the critical exemptions we seek in comprehensive data privacy laws across the country.

For those who couldn’t attend live or wish to revisit key highlights, you can access the recording below.

Webinar Recording

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AdvaMed’s digital health policy expert, Geeta Pamidimukkala, and payment and health care delivery policy expert, Kirsten Tullia, break down how artificial intelligence and machine learning (AI/ML) technologies are transforming patient care and the FDA’s crucial role in overseeing AI-powered medical devices.

For those who couldn’t attend live or wish to revisit key highlights, you can access the recording below.

Webinar Recording

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State Advocacy Resources

Advocacy in Action

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Washington, D.C. – AdvaMed, the Medtech Association, today welcomed introduction in the U.S. Senate of bipartisan legislation to expedite Medicare coverage of FDA-“breakthrough”-designated medical technologies and diagnostic tests. The legislation, the Ensuring Patient Access to Critical Breakthrough Products Act, introduced by Sen. Todd Young (R-IN) and Sen. Alex Padilla (D-CA), is similar to H.R. 1691, which the U.S. House of Representatives Ways and Means Committee passed on a bipartisan basis in June.  

“The message is clear: With bipartisan legislation now introduced in both houses of Congress, it is time for Medicare to cover the breakthrough technologies to which so many patients are in need of access,” said AdvaMed President and CEO Scott Whitaker. “These medical technologies and diagnostic tests, by definition, are approved by FDA for patients who literally have no other options available to them currently. We can all agree that these patients deserve the best medical technology has to offer, so we urge Congress to pass this bipartisan legislation before the end of the year.” 

The FDA’s Breakthrough Devices Program is intended to provide patients and health care providers with timely access to emerging medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The FDA invites medtech innovators to seek the designation if their device meets the criteria. The accepted devices will receive prioritized FDA review. As of Sept. 30, 2024, 1,029 devices have received the designation, and 124 devices have received marketing authorization.

However, the Centers for Medicare and Medicaid Services (CMS) was slow to finalize an option for Medicare coverage of the procedures enabled through breakthrough devices. When CMS finally offered an option, the proposal was lacking, excluding diagnostics and providing for only a handful of devices to receive approval each year. In a recent op-ed for RealClear Health, Whitaker urged congressional approval of comprehensive legislation as the best solution for Medicare beneficiaries and suggested Congress provide CMS more resources if the agency lacks the capacity to consider more than only a few of the many devices that could help Medicare beneficiaries.  

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In July, five patient leaders traveled to Capitol Hill to share their personal stories and speak to their lawmakers about the need to expand access to artificial intelligence technologies for medical imaging. The fly-in was held by Right Scan Right Time, a patient platform supported by AdvaMed Imaging.

The patient constituents were welcomed into 16 lawmaker offices from 5 different states, where they discussed the potential for AI imaging technologies and advocated for increased access to these innovations. The advocates described how the lack of Medicare reimbursements for most AI medical imaging technologies prevents patients from benefitting from diagnostic AI. A few advocates even shared that they previously had misinterpreted scans, which may have been prevented if today’s AI technologies had been available to their care teams. Advocates urged their lawmakers to work with Medicare to promote patient access and establish a formalized payment pathway for these revolutionary technologies.

Through personal testimonies and bringing together the unique perspectives of cancer survivors and advocates, RSRT’s fly-in not only enabled legislators to hear real-life stories from their constituents but also helped formulate ongoing collaboration among policymakers and patients.

To help support access to innovative AI medical imaging technologies, click here.

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AdvaMed recently hosted an “AI Demo Day” on Capitol Hill, where a number of medical imaging innovators had the opportunity to showcase some of the latest artificial intelligence (AI) technologies to members of Congress and their staff.

Featuring imaging technologies from companies such as Siemens Healthineers and Philips, the event served to drive home the enormous potential that AI medical imaging has for the future of patient care and the need for the Centers for Medicare and Medicaid Services (CMS) to ensure patient access by implementing a payment pathway for AI-enabled medical technology.

AdvaMed’s AI Demo Day follows a letter sent by Senate AI Caucus Chairs, Senators Martin Heinrich (NM) and Mike Rounds (SD), along with Senators Marsha Blackburn (TN) and Todd Young (IN), urging CMS to develop a formal payment pathway for AI-enabled medical devices, linked here.

Only about 10 AI/ML medical device technologies are currently reimbursed by Medicare. With patients, providers, and lawmakers embracing AI-enabled medical devices, RSRT hopes that these cutting-edge, innovations will be accessible to all patients. This will only happen if federal policymakers establish Medicare reimbursement pathways for these technologies.

To read AdvaMed’s press release on AI Demo Day, click here.

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WASHINGTON – This week, AdvaMed, the Medtech Association, hosted an Artificial Intelligence (AI) Demonstration Day event on Capitol Hill showcasing AI-enabled medical devices and technologies from leading health care companies. The event was honorarily co-hosted by Senators Martin Heinrich (D-NM) and Mike Rounds (R-SD), co-chairs of the Senate AI Caucus.

During the event, leading health care companies educated policymakers and staff about the value of AI to patient care and highlighted the need for the Centers for Medicare and Medicaid Services (CMS) to formalize a payment pathway for AI-enabled medical technology to ensure patient access is seamless.

“A clear Medicare reimbursement pathway is critical to realize the promise of FDA-cleared, AI-enabled clinical technology to improve patient care,” said Scott Whitaker, AdvaMed President and CEO. “Because medtech is constantly evolving, giving clinicians enhanced options for patient diagnoses and treatments, it’s important that reimbursement policies keep pace. AdvaMed applauds the Senate AI Caucus for its leadership and support of policies to expand patient access to AI-enabled medical technologies. We look forward to continuing to work with Congress and CMS to ensure that Medicare beneficiaries can benefit from remarkable, proven medical technology as soon as it is authorized and available, not years after the fact.”

The event follows a letter sent last month by Senate AI Caucus Chairs, Sens. Heinrich and Rounds, and also signed by U.S. Senators Marsha Blackburn (R-TN) and Todd Young (R-IN), which urged CMS to develop a formal payment pathway for AI-enabled medical devices.

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The recent House Departments of Labor and Health and Human Services Appropriations report has important news highlighting continued momentum in Congress to improve patient access to innovative medical imaging technologies and evidencing that AdvaMed’s messaging and advocacy initiatives are resonating in Congress.

Let’s dig into the report.

Algorithm Based Health Services (ABHS)

On page 143, the House Committee highlights Algorithm Based Health Services (ABHS), stating, “algorithm-based healthcare services are provided through medical devices cleared by the FDA that rely on artificial intelligence, machine learning, or other similar software to produce quantitative and/or qualitative clinical information for use in the diagnosis or treatment of a patient’s condition.” The Committee encouraged CMS to ensure a stable and consistent payment pathway to support patient access to these services.

The Committee’s report follows a recent bipartisan Senate letter and a patient sign-on letter to Congress advocating that CMS consider policies that will create predictability for ABHS in the Hospital Outpatient Prospective Payment System (HOPPS). Unfortunately, CMS’ proposed HOPPS rule was silent on an ABHS payment pathway. AdvaMed will continue working with lawmakers to urge CMS to heed Congress’ advice and begin their work to create payment pathway for ABHS that offers patients access to AI-enabled medical devices.

Focused Ultrasound

The Labor-HHS appropriations report also contains good news for patients and innovators of focused ultrasound medical devices. Focused ultrasound is noninvasive, non-pharmacological, therapeutic technology to treat serious medical disorders including prostate cancer, essential tremor, Parkinson’s, Alzheimer’s, and pain.

On page 116 of the report, the Committee requests coordination across the National Institutes of Health (NIH) to drive further research into focused ultrasound applications. The report comes as AdvaMed recently brought together patients, physicians, and innovators, including the Focused Ultrasound Foundation, Profound Medical and Acoustic, for a day of educational meetings on Capitol Hill with lawmakers and staff to further educate Congress about the value of focused ultrasound technologies. AdvaMed extends our gratitude to our colleagues at Insightec, Sonoblate, and FocalOne for their support in making this patient fly-in a success. We especially thank Congresswoman Debbie Wasserman-Shultz (FL-25) for her leadership in Congress supporting patient access to focused ultrasound technologies.

It is vital Congress continues to hear directly for those whose lives are changed by the profound value focused ultrasound, and other medical technologies, bring to patient care.

AdvaMed also thanks the House Labor-HHS Appropriations subcommittee for its work and commitment to improve patient access to innovative medical devices.

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WASHINGTON – Today, the House Ways and Means Committee voted to pass the bipartisan H.R. 1691, Ensuring Patient Access to Critical Breakthrough Products Act, during a markup meeting. The legislation, introduced by Representatives Brad Wenstrup (OH-02), Suzan DelBene (WA-01), Gus Bilirakis (FL-12), Tony Cárdenas (CA-29), Blake Moore (UT-01), Terri Sewell (AL-07), Brett Guthrie (KY-02), and Anna Eshoo (CA-16), would ensure FDA-designated breakthrough technologies are covered for four years by Medicare, and during this period CMS would be required to make permanent coverage determinations for the devices.
 
“This is a major step forward on a policy that will make a big difference in the lives of Medicare beneficiaries. But it is really important that all medical technologies, including diagnostic tests, are included. We look forward to working further with Congress to ensure breakthrough diagnostics, such as those that would detect cancer and other major diseases earlier, are in the final legislation that passes Congress. This would not only save lives—it would reduce costs to our health care system as well. Although during the markup a formal, public acknowledgement was made that the intent was to include diagnostics in the legislation, we will aggressively work with the committee to ensure the change is made before the legislation moves to the House floor. We know this legislation is also a priority for the Energy & Commerce Committee and look forward to progress there,” Scott Whitaker, AdvaMed President and CEO said.

 “As we continue to wait for CMS to finalize TCET, which was repealed 1,215 days ago, it is reassuring to see Congress step up and take action on behalf of Medicare beneficiaries. We thank Reps. Wenstrup and Del Bene and all the bill’s cosponsors for their leadership, and Chairman Smith and the Ways & Means Committee for today’s markup of this important legislation.”

Earlier this year, Whitaker sent a letter to CMS Administrator Chiquita Brooks-LaSure outlining the medtech industry’s disappointment in the lack of a finalized TCET rule. 

From the letter: “CMS’s delay in finalizing TCET is puzzling. The ability to establish a workable policy to ensure Medicare coverage of safe, effective, FDA-designated and market-authorized breakthrough devices should be easily within the agency’s grasp.   

“Medicare beneficiaries have waited long enough—too long—for coverage of breakthrough medical technologies to prevent, diagnose, and treat the chronic conditions from which they are suffering unnecessarily.” 

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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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