Ensuring equal access to artificial intelligence-enabled medical devices for everyone

Recent advances in health technology innovation should result in higher standards of care and improved patient outcomes. As medicine advances, so should public policy, especially Medicare reimbursement. Otherwise, many patients will not have access to scientific and medical breakthroughs, perpetuating inequalities in access to care for disadvantaged communities.

Take, for example, artificial intelligence (AI)-enabled medical imaging devices. These tools can improve clinical care and the operation of medical practices.

AI tools can enhance a radiologist’s ability to detect abnormalities in a scan that may have been missed, helping to identify and treat curable cancers more easily and effectively.

AI can also alert radiologists to a scan that requires immediate attention, putting it at the front of the queue. Artificial intelligence-powered medical imaging devices enable radiologists to do their jobs more efficiently. These technologies can also use lower doses of radiation, minimizing the risk to a patient’s health and well-being.

Artificial intelligence-based health technology also helps improve physician efficiency and productivity. This reduces burdensome administrative tasks, allowing providers to focus more on patient care. This helps alleviate one of the leading causes of physician burnout, which is especially common in underserved and often understaffed rural and urban communities.

To date, the Food and Drug Administration (FDA) has approved nearly 700 AI-enabled medical devices, most of which are used in radiology. While this should be a positive development for patient care, the Centers for Medicare and Medicaid Services (CMS) has approved fewer than ten claims for AI-enabled medical devices for reimbursement, with payment paths for other new technologies challenging. Complicated policies and limited reimbursement mean that doctors and hospitals will struggle to adopt and offer many of these revolutionary technologies.

With the increasing use of artificial intelligence in medical imaging and across the healthcare industry, it is time to consider how Medicare will pay doctors and hospitals that invest in breakthrough technologies.

The question of how these advanced technologies should be reimbursed is becoming increasingly important. If payers, led by Medicare, develop better mechanisms to reimburse providers for the use of AI-based technologies that improve patient outcomes and lower costs, patients who cannot afford higher out-of-pocket costs will have the same access to innovative technologies as those who which can. AI-specific payment pathways and separate reimbursement for use of AI clinical tools by payers will likely provide all patients with improved access to care.

Just look at the increase in telehealth use after Medicare began reimbursing doctors for these services. Before the pandemic, physicians were not reimbursed for telehealth and were reluctant to use it. As the pandemic spread, the agency rightly recognized the benefits these technologies provided and created more formal pathways for physician reimbursement. This increased access to care for patients – especially in regions with insufficient access to medical services and for people struggling with health problems that prevent them from visiting a doctor in person.

The same pattern would emerge if Medicare were to follow a similar model and establish a payment system that separately reimburses providers for using FDA-approved AI clinical applications. That’s why CMS—as part of its annual rulemaking process—should publish a formalized payment pathway for AI in FDA-regulated medical imaging devices in its 2025 Potential Outpatient Payment Systems rule.

If Medicare takes action, the potential of AI-based technologies to improve health care outcomes for patients, regardless of their geographic location or socioeconomic status, will come closer to being fully realized. Reimbursing physicians and providers for these increasingly important services is the simplest and most effective way CMS can help ensure that all patients have equal access to clinical innovations that can help improve and save lives.

Photo: zimmytws, Getty Images

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