Most people are in favor of medical device innovation. The development and release of new technologies that address disease and medical conditions in novel ways are typically a benefit to healthcare providers and their patients. Unfortunately, the pathway to market (more specifically, the reimbursement pathway) for new technologies is not always received with as much positivity. In fact, truly unique innovations can be stalled as they aren’t immediately supported financially by CMS or private payers. This can result in the end of a fantastic new technology before it even has a chance to make an impact.

This is not an unfamiliar story in the medical device manufacturing industry. Within the last few years, there’s been turmoil over the proposed pathways for gaining reimbursement for devices designated as breakthrough by the FDA. One plan had these devices granted guaranteed reimbursement for four years, but unfortunately, that was scrapped and replaced with the Transitional Coverage for Emerging Technologies (TCET) proposal. Better than nothing at all, but it lacked the comprehensive coverage offered by its predecessor. 

Now, politicians from both sides of the aisle—Senators Mike Rounds (R-SD) and Martin Heinrich (D-NM)—have proposed a bill to address reimbursement for devices that leverage artificial intelligence (AI) and machine learning (ML), also known as algorithm-based healthcare services (ABHS). The fact a Republican and Democrat have co-sponsored the bill offers hope it will gain additional support from representatives of both parties. Additionally, given President Trump’s seemingly positive outlook on AI, he would hopefully support its passage, as well. 

While I’m in favor of the idea for this bill on the surface, I do have a question that I’m not sure I can answer from the current version of the bill. What is the definition of ABHS? The bill attempts to clarify this, but I’m not sure I can interpret the legaleze or Congressional language used. “…a device cleared or approved by the Food and Drug Administration that uses artificial intelligence, machine learning, or other similarly designed software to yield clinical outputs or generate clinical conclusions for use by a physician or practitioner in the screening, detection, diagnosis, or treatment of an individual’s condition or disease, or any such other similar service as the Secretary determines appropriate in consultation with appropriate organizations.”

Who are the appropriate organizations? Is it the FDA? Is it software experts? Is it the developer or medical device company on the label? Also, I’m curious about the portion that identifies “other similarly designed software,” which indicates to me software that isn’t AI- or ML-based would qualify. 

These may be minor imperfections for this bill, and perhaps the value of such a proposal clearly outweighs my inquiries. The industry, thus far, seems to be in support of it. 

“With AI-enabled medical technologies already making remarkable strides in patient care, and with even more incredible strides ahead of us, now is the time to establish a predictable reimbursement pathway. We thank Senators Rounds and Heinrich for their leadership and strongly urge Congress to pass this bipartisan legislation,” stated Scott Whitaker, president and CEO of AdvaMed. “It is critical to advancing the medical progress upon which patients depend and which is being driven by medtech.”

Peter J. Arduini, president and CEO of GE HealthCare (arguably one of the leading medtech firms for AI-enabled devices), and chair of AdvaMed’s Board of Directors, agreed, “Senator Rounds and Senator Heinrich have shown their deep knowledge of how AI is used in healthcare, and we greatly appreciate their leadership. The Health Tech Investment Act would help bring beneficial medical innovation to patient care by ensuring a clear payment pathway for algorithm-based healthcare services. We look forward to working with members of Congress to pass this important legislation and help bring these latest technologies to patients.”

And that’s really the key here. Regardless of the minutiae of a potential problem with phrasing or clarity, it’s more important to get this type of legislation passed so patients don’t have to go without. As was the case with the TCET plan, better to have something than nothing at all that helps pave that pathway to reimbursement for advanced innovation. 

Dave Pacitti, president of Siemens Medical Solutions USA, Head of the Americas, Siemens Healthineers, and chair of the AdvaMed Medical Imaging Division Board of Directors, added, “Introduction of the Health Tech Investment Act is an important step towards expanding patient access to AI solutions in screening, diagnosing, and treating cancer, neurovascular, cardiovascular, and other diseases.”

Sean Fenske, Editor-in-Chief
sfenske@rodmanmedia.com