Explore and discuss the current Centers for Medicare & Medicaid Services (CMS) process and policies, payment for digital health technologies, private payer challenges and more.

AdvaMed Payment Policy Forum

May 20, 2025: 8:15 AM – 4:15 PM ET
May 21, 2025: 8:15 AM – 1:00 PM ET

Register now

Overview

1. Overview
2. Agenda
3. Speakers
4. Registration & Location

AdvaMed Payment Policy Forum

May 20, 2025: 8:15 AM – 4:15 PM ET
May 21, 2025: 8:15 AM – 1:00 PM ET

Register now

Join AdvaMed for the Payment Policy Forum hosted in Washington, D.C., May 20-21, 2025! The Payment Forum is the ultimate gathering for veteran medtech professionals seeking insights into the changing payment landscape. This Forum goes beyond the basics, offering in-depth discussions on the most pressing issues facing medtech companies today. Whether it’s navigating complex reimbursement pathways, understanding emerging CMS policies, or preparing for changes in coding and coverage requirements, this dynamic program will help your craft successful strategies for your organization, so secure your spot to join us this Spring.

Known for its exclusive access to top decision-makers, this in-person event is your opportunity to stay ahead in changing medtech payment policies. Sign-up to be among the first to receive programming updates and prepare to elevate your expertise in medtech payment policies!

Who Should Attend

Take a look at the 2024 Forum attendee list to preview the participating companies you can connect with at this outstanding event

• MedTech market access professionals and leaders. This event will dive deeper into key coding, coverage and payment issues.
• MedTech professionals looking to engage CMS staff and other key opinion leaders.

The 2025 agenda has not been released yet, in the meantime view the 2024 agenda below. Join our mailing list to be the first to know when our 2025 program is live!

2024 Schedule

Tuesday, May 21
8:15 am – 9:00 am	Check in & Networking Breakfast
9:00 am – 9:05 am	Welcome Remarks
9:05 am – 11:00 am	Medicare Advantage Bootcamp Jim Mathews, Principal, Health Policy Alternatives  Pierre Poisson, Principal, Health Policy Alternatives   – Contextualize recent and rapid growth of the Medicare Advantage Program and discuss similarities to/differences from Traditional Medicare  – Explore ins-and-outs of Medicare Advantage program administration, including supplemental benefits program  – Discuss ongoing concerns regarding Medicare Advantage plans, including increasing use of prior authorization  – Review recent CMS regulations and guidance on increased oversight of the Medicare Advantage program
11:00 am – 11:15 am	Break
11:15 am – 12:00 pm	Pre-Lunch Keynote: Medicare Technologies Ombudsman TJ Sutphin, New Technology Liaison and Acting Pharmaceutical and Technology Ombudsman, Centers for Medicare & Medicaid Services   Keynote remarks include:    – A review of the role of the new technology ombudsman  – A discussion of opportunities to receive assistance navigating CMS  – An introduction to CMS Guide to Medical Technology Companies
12:00 pm – 1:00 pm	Networking Lunch
1:00 pm – 2:00 pm	Commercial Payor Issues Moderator: Carla Monacelli, Strategic Advisor, JD Lymon Ben Finder, Vice President of Coverage Policy, American Hospital Association  A panel discussion of issues including:   – Current issues with commercial payors, including utilization management and customer service    – Tips on interacting and obtaining coverage with commercial payer plans  – Study design and evidence generation
2:00 pm – 3:00 pm	Medicaid Issues Moderator: Julie Khani, Corporate Vice President, Government Affairs and Corporate Communications, Hologic  Phillip Burrell, Director, Marwood Group Craig Kennedy, President and CEO, Medicaid Health Plans of America  Andrey Ostrovsky, Managing Partner, Social Innovation Ventures; Former US Medicaid Chief Medical Officer  This panel discussion will cover:  – Medicaid unwinding   – Medicaid coverage and payment for pediatric devices  – Impact of Medicaid reimbursement policy on women’s health   – Coding implication for diagnostic tests
3:00 pm – 3:15 pm	Break
3:15 pm – 4:15 pm	Digital Health Tech Payment  Moderator: Kirsten Tullia, Senior Vice President, Payment and Healthcare Delivery Policy, AdvaMed  Richard Frank, Principal, Frank Healthcare Advisors, LLC  Brian Lee, Partner, Alston & Bird  Paul Radensky, Senior Counsel at McDermott, Will & Emery LLP   A panel discussion of issues including:  – Payment for different types of digital health technology, including digital therapeutics and AI-enabled imaging  – Coverage of AI and ML technologies across settings of care  – Opportunities for improvement in CMS’ durable medical equipment pathways to reflect innovative new technologies
4:15 pm	Networking Reception

Wednesday, May 22
8:15 am – 9:00 am	Networking Breakfast
9:00 am – 9:05 am	Welcome Remarks
9:05 am – 10:00 am	AMA CPT Session: Coding Change Application Process and Challenges Moderator: Tara Burke, Vice President, Payment and Healthcare Delivery Policy, AdvaMed   Zach Hochstetler, Vice President, Coding and Payment, American Medical Association  Josh Makower, Professor of Medicine & Bioengineering, Director & Co-Founder, Stanford Byers Center for Biodesign at Stanford University School of Medicine; Founder & Exec Chairman, ExploraMed   – Review code change application criteria (CCA) and process  – Overview of preliminary findings from Stanford Biodesign stakeholder survey on CPT application process  – Discuss CPT CCA process challenges
10:00 am – 10:50 am	CMS Session #1: Medicare FFS  Moderator: Kirsten Tullia, Senior Vice President, Payment and Healthcare Delivery Policy, AdvaMed Jason Bennett, Director, Technology, Coding, and Pricing Group, Center for Medicare, Centers for Medicare & Medicaid Services  Ryan Howe, Director, Hospital & Ambulatory Policy Group, Centers for Medicare & Medicaid Services  TJ Sutphin, New Technology Liaison and Acting Pharmaceutical and Technology Ombudsman, Centers for Medicare & Medicaid Services CMS leaders will provide an overview of their roles within Medicare Fee for Service and their policy priorities, highlighting opportunities for medtech engagement in policy development. Robust question-and-answer session to follow.
10:50 am – 11:10 am	Networking Break
11:10 am – 12:00 pm	CMS Session #2: Medicare Coverage  Moderator: Amber Stock, Vice President, Payment and Healthcare Delivery Policy, AdvaMed  Tamara Syrek-Jensen, Director, Coverage and Analysis Group, Center for Clinical Standards and Quality, Centers for Medicare & Medicaid Services  Elizabeth Truong, Director, Division of Policy Coordination & Implementation, Centers for Medicare & Medicaid Services CMS leaders will provide an overview of their roles in Medicare and Medicaid coverage policymaking, including the National Coverage Determination and Local Coverage Determination development processes, and their policy priorities. Robust question-and-answer session to follow.
12:00 pm	Program Concludes

View the 2024 Forum speaker lineup of CMS, industry, and academic speakers to preview who you can expect to see in 2025.

2024 Speakers

Jason Bennett, Director of the Technology, Coding, and Pricing Group, Centers for Medicare & Medicaid Service

Jason Bennett is the Director of the Technology, Coding, and Pricing Group at the Centers for Medicare & Medicaid Services (CMS). This Group serves as a focal point for manufacturers to engage with Medicare fee-for-service on coding and payment for new products that Medicare beneficiaries and their clinicians may choose when making their health care decisions. Since joining CMS in 2017, Jason has served in leadership and senior advisor roles on Medicare policy and program issues. Prior to joining CMS, Jason served in a series of progressive management and analytical roles across the Department of Health and Human Services since 2005. His prior roles include serving in the Office of the Secretary, the Health Resources and Services Administration (HRSA), and as the first-ever chief of staff at the Administration for Community Living (ACL), working on aging and disability policies and programs. His broad range of operational and policy experience includes the response to the COVID-19 pandemic, 340B drug discount program, organ transplantation, workforce development and shortage issues, rural health, food and drug regulation, post-acute care and long-term services and supports, end-stage renal disease, the launch of the Medicare Part D program in 2005-2006, and budget formulation and execution.

Ben Finder, Vice President of Coverage Policy, American Hospital Association

Benjamin Finder, M.P.H., is Vice President of Coverage Policy at the American Hospital Association (AHA). He provides policy and data analysis to support the Association in its advocacy efforts and in the development of well-informed policy positions.

Prior to joining the AHA, he was a senior analyst at the Medicaid and CHIP Payment and Access Commission, a legislative advisory commission that provides policy analysis and makes recommendations to Congress. He has also served as an associate director at the District of Columbia’s Medicaid agency, the Department of Health Care Finance, and as a policy analyst at the Kaiser Family Foundation, where he performed data analysis of health expenditures, and trends in employer-sponsored health insurance.

Mr. Finder holds a Master of Public Health from The George Washington University, where he concentrated in health policy and health economics. He received his bachelor’s degree from Washington University in St. Louis.

Richard A. Frank, MD, PhD, Principal, Frank Healthcare Advisors, LLC

Zach Hochstetler, Vice President, Coding and Payment, American Medical Association

Zach Hochstetler is the director of CPT Editorial and Regulatory Affairs in the American Medical Association’s Health Solutions business unit. Zach’s work focuses on several key areas that include leading and setting strategic direction for the CPT Editorial Panel and directing the communication of health care policies, through identification and resolution of national payment and reporting problems. He is also the secretary of the CPT Editorial Panel, ensuring that the process remains open and transparent.

Ryan Howe, PhD, Director, CMS/Hospital & Ambulatory Policy Group

Ryan Howe is the Director of the Hospital and Ambulatory Policy Group in the CMS Center for Medicare. He has previously served in several leadership positions within the Center for Medicare and focused expertise on a wide range of payment issues, including for professional and other ambulatory services, hospital services, telehealth services and Part B drugs.

Julie Khani, Corporate Vice President, Government Affairs and Corporate Communications, Hologic

Julie Khani leads Hologic’s internal and external communications and government affairs strategies, enhancing and protecting the company’s reputation and brand with policymakers, the media, key stakeholders and the general public. She was president of the American Clinical Laboratory Association prior to joining Hologic in 2021. Previously, she served in senior roles at the National Association of Chain Drug Stores, Ford Motor Company and Planned Parenthood Pennsylvania Advocates. She holds a Bachelor of Arts from New York University and a Master of Public Administration from George Washington University.

Brian Lee, JD, MPH, Partner, Alston & Bird LLP

Brian Lee is a partner with Alston & Bird’s Health Care Group and focuses his practice on regulatory and legislative issues concerning federal reimbursement for and regulation of physicians, hospitals, post-acute care providers, insurers, and manufacturers. Brian assists clients in navigating Medicare coverage and reimbursement requirements and Medicare payment policies and provides counsel on the development and implementation of strategic initiatives in response to congressional and administrative coverage and reimbursement changes.

Brian currently serves as legislative and regulatory counsel for state and national health care trade associations, innovative technology manufacturers, and providers and suppliers participating in alternative payment models and delivery system reform initiatives.

Before joining Alston & Bird, Brian served as a consultant for a health care policy research and management consulting firm, where he advised government entities on congressional action and their impact on Medicare, counseled on Medicare reimbursement issues, and developed methods to assess, review, and evaluate alternative payment models, including changes that waive the Anti-Kickback Statute and Stark Law.

Chris Lyle, Partner, JD Lymon 

Josh Makower, MD, MBA, Director, Stanford Biodesign

Josh Makower is the Yock Family Professor of Medicine and Bioengineering at the Stanford University Schools of Medicine and Engineering, and is the Director and Co-Founder of the Stanford Byers Center for Biodesign. Josh is the Founder and Executive Chairman of ExploraMed, a medical device incubator that has created 10 companies over the past 20 years. Lastly, Josh is also a Senior Advisor to Patient Square Capital, and an Advisory Venture Partner with Sofinnova Partners. Josh currently serves on the boards of Elevage, Revelle Aesthetics, ExploraMed, Moximed, Willow, X9 and Coravin.

Josh holds over 300 patents and patent applications for various medical devices in the fields of cardiology, ENT, general surgery, drug delivery, plastic surgery, dermatology, aesthetics, obesity, orthopedics, women’s health, and urology. He received an MBA from Columbia University, an MD from the NYU School of Medicine, and a Bachelor’s degree in Mechanical Engineering from MIT. Josh is a Member of the National Academy of Engineering, a Fellow of The National Academy of Inventors and The American Institute for Medical and Biological Engineering and was awarded the Coulter Award for Healthcare Innovation by the Biomedical Engineering Society in 2018.

Andrey Ostrovsky, MD, Managing Partner, Social Innovation Ventures; Former US Medicaid Chief Medical Officer 

TJ Sutphin, Acting Pharmaceutical & Technology Ombudsman, Centers for Medicare & Medicaid Services

Anthony (TJ) Sutphin serves as the acting Medicare Pharmaceutical and Technology Ombudsman (PTO) within the Centers for Medicare & Medicaid Services (CMS) Offices of Hearings & Inquiries (OHI). In this capacity, he also serves as a new technology liaison working closely with colleagues in the Technology, Coding and Pricing Group and other CMS Groups to support engagement with medical device, pharmaceutical, and biotechnology manufacturers and other stakeholders. He has experience with and works to assist medical technology innovators with engaging CMS and addressing coding, payment, and coverage matters/concerns and inquiries. Prior to taking on this role, TJ worked as an Associate Ombudsman providing key support to the Medicare Beneficiary Ombudsman (MBO), Competitive Acquisition Ombudsman (CAO), and PTO in assisting Medicare beneficiaries and other stakeholders.

Tamara Syrek Jensen, JD, Director, Coverage and Analysis Group, Centers for Medicare & Medicaid Services

Tamara is the Director of the Coverage and Analysis Group in the Centers for Clinical Standards and Quality at the Centers for Medicare & Medicaid Services (CMS). CAG is responsible for developing evidence based polices such as national coverage determinations (NCDs) and overseeing the local coverage determination process. Tamara leads the CMS collaboration with FDA, including the CMS-FDA parallel review program and the investigational device exemption (IDE) program. To assist in generating evidence for the Medicare population, Tamara is one of the principal authors in creating and implementing coverage with evidence development (CED), an initiative that allows for Medicare coverage while developing evidence through clinical studies, including registries. Tamara was recently awarded the 2022 CMS Executive of the Year.

Elizabeth Truong, MHS, Director of the Division of Policy Coordination and Implementation at the Centers for Medicare & Medicaid Services

Elizabeth Truong is the Director of the Division of Policy Coordination and Implementation at the Centers for Medicare & Medicaid Services (CMS). This Division is primarily responsible for providing oversight of Medicare’s local coverage determinations, implementation of national coverage determinations, and rulemaking for national coverage policies. Ms. Truong’s 20 years at CMS includes experience in developing Medicare payment policies to reimburse hospitals and clinicians (the Inpatient Prospective Payment System, the Long-Term Care Hospital Prospective Payment System, and the Physician Fee Schedule) as well as leading the development and implementation of innovative payment models that bundled hospital and physician reimbursement to better align payment incentives. She also served as the Director for the Budget and Audit Division at CMS’ Innovation Center.

Registration Pricing

Check to see if your company is an AdvaMed member here.

AdvaMed Accel Member Companies: $765

AdvaMed Member Companies: $1,075

Non-Members: $1,575

Government/Academic: $765

Location

Hogan Lovells | 555 13th St NW, Washington, DC 20004

The 2025 Payment Forum will be hosted in the Hogan Lovells office located in the heart of Washington, DC.

The post AdvaMed Payment Policy Forum appeared first on AdvaMed.

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.  

The post AdvaMed Welcomes Bipartisan Senate Bill to Expedite Medicare Coverage of Breakthrough Medical Technologies, Diagnostic Tests appeared first on AdvaMed.

Washington, D.C. –  AdvaMed, the Medtech Association, today said two new final payment rules from the Centers for Medicare and Medicaid Services (CMS) for 2025 contain several important provisions that will improve access to care and improve outcomes for millions of Medicare beneficiaries. The measures include longstanding priorities for patient groups, providers, and medtech innovators. 

“CMS made welcome, much-needed changes that will improve the diagnosis and treatment for Medicare beneficiaries in important ways next year,” said Scott Whitaker, president and CEO of AdvaMed. “I commend the agency for listening to patient groups, providers, and medtech innovators and expanding access to exciting medical technologies created to help as many patients as possible enjoy their best health. Medicare beneficiaries and their health care providers will appreciate these valuable new options.” 

The Calendar Year 2025 Hospital Outpatient Prospective Payment System (HOPPS) and Ambulatory Surgical Center Payment System final rule and the Calendar Year 2025 Medicare Physician Fee Schedule final rule include: 

• Separate reimbursement to hospitals for certain diagnostic radiopharmaceuticals to expand patient access to innovative imaging exams. The provision will help millions of patients benefit from this technology, used to diagnose illnesses including Alzheimer’s, Parkinson’s, heart disease, and certain types of cancer.  

• Expanded access to colorectal cancer screening, including covering computed tomography colonography (CTC), also known as a virtual colonoscopy, to provide Medicare beneficiaries access to a minimally invasive colorectal cancer screening tool that can detect pre-cancerous polyps and does not require anesthesia. Medicare also will cover blood-based biomarker screening tests as part of the screening continuum. Given the rate of colorectal cancer in the United States and higher rates of colorectal cancer in African Americans, providing additional options for screening is critical to earlier diagnosis and treatment.   

• Medicare payment for digital mental health treatment devices, a subset of FDA-regulated digital therapeutics, furnished incident to or integral to professional behavioral health care treatment under a behavioral health treatment plan of care. This new coverage policy is a good start to the conversation and reflects a narrow, but clear, subcategory of digital therapeutics for mental health disorders. FDA-regulated digital therapeutics stand to expand beneficiary access to evidence-based treatment for a wide range of mental and behavioral health conditions, and AdvaMed looks forward to continuing to engage with CMS to provide coverage for safe, effective medical devices.  

• Establishing a process for extending temporary additional payments for certain non-opioid treatments for pain relief. This implementation process outlines evidence requirements for medical devices to demonstrate the ability to replace, reduce, or avoid intraoperative or postoperative opioid use or the quantity of opioids prescribed. There are many ways to treat pain, and extending additional payment for medical devices in this space will help further combat the ongoing opioid epidemic. 

The post AdvaMed: Final CMS Payment Rules Contain Significant Victories for Patients appeared first on AdvaMed.

In letter to CMS: Gap in Coverage is an “Unacceptable Barrier” to Millions of Women with “Dense Breast Tissue”

Washington, D.C. –  AdvaMed, the Medtech Association, called on Medicare in a letter sent Friday to cover supplemental imaging for women with heterogeneously and extremely dense breast tissue, noting the life-saving value of the additional screening and the pressing health equity needs Medicare coverage of these critical services would address.   

“While supplemental imaging increases the effectiveness of detecting breast cancer in women with dense breast tissue, cost, availability, and insurance coverage limit its use,” Scott Whitaker, AdvaMed President and CEO, wrote to leaders at the Centers for Medicare & Medicaid Services. “As a result, beneficiaries may either forgo supplemental imaging or are surprised by bills, especially when those exams were recommended and ordered by their healthcare provider.”   

“Only 23% of Medicare beneficiaries are enrolled in a Medigap plan, leaving most without coverage for these cost-sharing gaps. This is an unacceptable barrier, especially given recently enacted FDA requirements that women be notified about their breast density and the inherent risk of dense breast tissue. AdvaMed urges CMS to cover imaging, in addition to a mammogram, for women with heterogeneously or extremely dense breast tissue,” the letter continues.  

Effective in September, the FDA requires mammographers to notify women when they have dense breast tissue. While traditional mammography is an important screening tool, it is less sensitive in women with dense breasts and more likely to miss cancer, especially at the critical early stages, than other imaging technologies such as ultrasounds, magnetic resonance imaging (MRI), or contrast-enhanced mammography.  

Breast cancer is the most diagnosed cancer among U.S. women. Seven out of ten cases of breast cancer are diagnosed in women aged 55 years and older. Additionally, nearly half of all women 40 and older who get mammograms are found to have dense breast tissue.  

Black women are often diagnosed with breast cancer at more advanced stages when treatment options are more limited, costly, and result in death rates 40 percent higher than white women. Black women may face worse disease progression in part because of their increased likelihood of having dense breast tissue.    

Recognizing these needs, a number of state legislatures have enacted legislation requiring insurers to cover supplemental breast cancer screening for women who need it. An additional number of states are considering such legislation. In Congress, a number of pending bills would require such coverage. Patient advocates have led this advocacy work, with strong support from AdvaMed and its member companies that innovate breast cancer screening technologies. AdvaMed thanked Senators Amy Klobuchar and Dr. Roger Marshall for their continued efforts to expand access to breast cancer screening by introducing the bipartisan Find it Early Act.  

Medicare coverage of supplemental imaging would close coverage gaps for women and save lives in states without laws covering additional imaging. Medicare coverage also would set an important precedent for state Medicaid programs and private health insurance plans, which often follow Medicare, as the nation’s largest insurance provider, in coverage decisions.  

###  

The post AdvaMed Calls on Medicare to Cover Supplemental Imaging as Part of Breast Cancer Screening appeared first on AdvaMed.

WASHINGTON – AdvaMed, the Medtech Association, today praised The Centers for Medicare and Medicaid Services (CMS) Hospital Outpatient Prospective Payment System (HOPPS) and Ambulatory Surgical Center Payment System rule for CY25 for having significant wins for patient access to care while also urging the agency to “implement policy changes that will ensure beneficiary access to medically necessary” services “delivered through a Food and Drug Administration (FDA) approved or cleared medical device, that utilizes artificial intelligence (AI), machine learning (ML).”

In its letter on the final HOPPS rule AdvaMed highlighted the following topics:

• The need for a formalized payment pathway in the HOPPS for algorithm-based healthcare services;
• Support for CMS’s proposed payment policy for diagnostic radiopharmaceuticals;
• Support for the Centers for Medicare and Medicaid Services’ (CMS) proposal to cover CT colonoscopy (CTC); and
• Appropriate payment for cardiac CT services.

Payment Policies for Algorithm-Based Healthcare Services, Including Software as a Service

In its letter, AdvaMed wrote that “ABHS is a service delivered through a Food and Drug Administration (FDA) approved or cleared medical device, that utilizes artificial intelligence (AI), machine learning (ML), or other similar technology to produce quantitative and/or qualitative clinical information that cannot otherwise be obtained by a health care provider and provides “clinicians with new or additional information that cannot always be discerned from a previously acquired medical image or service.”

AdvaMed cautioned that “the current HOPPS framework does not support access to or adoption of ABHS in all of its forms. Without such a framework, we are deeply concerned that the future of ABHS will overwhelm CMS’s ability to assess reimbursement using existing pathways. We therefore recommend that CMS implement policy changes that will ensure beneficiary access to medically necessary ABHS technologies.”

Separate Payment for Certain Radiopharmaceuticals

AdvaMed praised CMS’s final rule “to separately pay for diagnostic radiopharmaceutical with a per day cost greater than $630” writing it will “reduce financial barriers for providers that limit beneficiary access to such imaging.”

AdvaMed wrote that the agency’s continued engagement with stakeholders results in a final rule with “payment methodology that will pay more appropriately for nuclear imaging using advanced diagnostic radiopharmaceuticals.”

Coverage of CT Colonography

AdvaMed’s letter strongly supports CMS’s proposal to cover computed tomography colonography (CTC) to provide beneficiaries access to a minimally invasive colorectal cancer screening tool that can detect pre-cancerous polyps and does not require anesthesia.

“Given the rate of colorectal cancer in the US and higher rates of colorectal cancer in African Americans, providing an additional option for screening is welcome,” AdvaMed wrote. To ensure that CTC is appropriately adopted, AdvaMed said it agrees with the American College of Radiology and other stakeholders urging CMS to “assign this service to a higher APC to recognize the resources involved in providing this procedure.”

###

The post AdvaMed: Final CMS Hospital Outpatient Payment Rule Contains Significant Improvement for Patient Access to Care appeared first on AdvaMed.

WASHINGTON – AdvaMed, the Medtech Association, released the following statement from President and CEO Scott Whitaker on the final Transitional Coverage for Emerging Technologies (TCET) notice from the Centers for Medicare and Medicaid Services (CMS):

“The final TCET notice is a step toward a stronger, more robust policy, but doesn’t go far enough to help the Medicare seniors depending on breakthrough diagnostics and treatments to alleviate their suffering. The limited number of devices CMS can handle demonstrates clearly to Congress the need for greater resources at CMS. And the exclusion of diagnostics is disappointing, particularly considering the potential for a breakthrough diagnostic technology to save not only lives but costs to the health care system overall through earlier detection. While we appreciate that CMS has released the rule, we call on Congress to finish the job by passing HR 1691, the Ensuring Access to Critical Breakthrough Products Act. Too many patients in need of breakthrough diagnoses and treatments are counting on it.”

The post AdvaMed Statement on Final TCET Notice appeared first on AdvaMed.

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.

###

The post AdvaMed Hosts Showcase on Capitol Hill, Urges Action on Reimbursement Pathway for AI-Enabled Medical Technology appeared first on AdvaMed.

Calls on CMS to continue work on payment, coverage of AI- and ML-driven medtech

WASHINGTON – Today, the Centers for Medicare and Medicaid Services (CMS) issued the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System proposed rule for CY25, which includes significant wins for patients, including separate payments for diagnostic radiopharmaceuticals, which improves access and ensures better treatment and care. Also of note, CMS’s proposed rule includes coverage for CT Colonography, or virtual colonoscopy, an important tool in detecting colorectal cancer.

“CMS’s proposal to include separate payments for diagnostic pharmaceuticals is an important step forward, particularly for patients suffering from Alzheimer’s, Parkinson’s, heart disease, and certain types of cancer. We thank the agency for listening to us and the patient groups advocating for this much-needed change,” said Scott Whitaker, AdvaMed President and CEO. “There is still more work to be done, especially for coverage of the next generation of medical technologies driven by AI and machine learning. We look forward to working further with CMS, patient groups, and policymakers to ensure CMS is as innovative and nimble in its coverage and payment policies as the medical technologies themselves.”

“CMS’s proposal for separate payment of diagnostic radiopharmaceuticals is welcome news to millions of patients and their family members who will now have better access. With this proposal, CMS is recognizing the value of diagnostic radiopharmaceuticals and the importance of expanding access of these diagnostic imaging agents to more patients so that they might receive better treatment and care,” said Patrick Hope, AdvaMed Medical Imaging Executive Director.“Achieving separate payment for diagnostic radiopharmaceuticals continues to be a top priority for AdvaMed members.  We look forward to working with all stakeholders in support of finalizing this proposal.”

###

The post AdvaMed Praises CMS Draft Rule Improving Patient Access to Alzheimer’s, Cancer Diagnostics appeared first on AdvaMed.

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.” 

###

The post House Committee Advances Bipartisan Bill to Expedite CMS Coverage of Breakthrough Medtech appeared first on AdvaMed.

WASHINGTON – This week, AdvaMed, the Medtech Association, applauded a bipartisan group of Senators for urging the Centers for Medicare & Medicaid Services (CMS) to develop a formalized payment pathway for algorithm-based health care services (ABHS) in the upcoming Hospital Outpatient Prospective Payment Systems (HOPPS) rulemaking cycle. ABHS are FDA-cleared medical devices that rely on artificial intelligence (AI) and machine learning (ML) to produce clinical information to aid in patient diagnosis or treatment.

Scott Whitaker, president and CEO of AdvaMed said: “Ensuring patients have access to innovative AI-enabled clinical technology requires a formalized Medicare reimbursement pathway to provide manufacturers the certainty to deploy technology and providers the ability to invest in it. AdvaMed applauds these Senators for their commitment to ensure seniors benefit from proven medical innovation and looks forward to working with the Congress and CMS to realize the promise that FDA cleared, AI-enabled clinical technology can have to improve patient care.”   

The letter, led by the Senate AI Caucus Chairs, Senators Martin Heinrich (D-NM) and Mike Rounds (R-SD) and also signed by U.S. Senators Marsha Blackburn (R-TN) and Todd Young (R-IN), stated, “To ensure future innovation and to protect access to ABHS for Medicare beneficiaries, we urge CMS to develop a formal payment pathway for ABHS. We urge CMS to codify in regulation its existing Software-as-a-Service (SAAS) payment policy that the agency articulated in the calendar year 2023 Medicare HOPPS Final Rule to provide stability and certainty moving forward.”

The letter also included a note that,“ABHS can improve care delivery by providing clinicians with new or additional information about a patient’s specific clinical presentation. For example, ABHS can identify and qualify cancer, assess signs of liver disease, and measure the caliber of coronary arteries via medical technology not otherwise available to healthcare providers. These devices will improve patient outcomes, and some ABHS are now part of the standard of care for certain conditions.”

The letter continued that without a formalized reimbursement pathway for ABHS: “Manufacturers face an uncertain regulatory landscape, and providers must balance the benefit of ABHS against unpredictable payment policies.” The Senators go on to further write that while CMS provides separate payment for a limited number of ABHS, CMS should adopt a uniform payment policy to increase efficiency and include more of the hundreds of FDA-approved or cleared ABHS medical devices.

The full letter is available here.

The post AdvaMed Applauds Bipartisan Senate Letter Urging CMS to Establish a Reimbursement Pathway for AI-Enabled Medical Devices appeared first on AdvaMed.