Tag: medical AI

FDA Data Show AI Approval Boom

Posted on by Brian Casey

In the previous issue of The Imaging Wire, we discovered how venture capital investment in AI developers is fueling rapid growth in new AI applications for radiologists (despite a slowdown this year). 

This trend was underscored late last week with new data from the FDA showing strong growth in the number of regulatory authorizations of AI and machine learning-enabled devices in calendar 2023 compared to the year before. The findings show:

  • A resurgence of AI/ML authorizations this year, with over 30% growth compared to 14% in 2022 and 15% in 2021 – The last time authorizations grew this fast was in 2020 (+39%)
  • The FDA authorized 171 AI/ML-enabled devices in the past year. Of the total, 155 had final decision dates between August 1, 2022 to July 30, 2023, while 16 were reclassifications from prior periods 
  • Devices intended for radiology made up 79% of the total (122/155), an impressive number but down slightly compared to 87% in 2022 
  • Other medical specialities include cardiology (9%), neurology (5%), and gastroenterology/urology (4%)

One interesting wrinkle in the report was the fact that despite all the buzz around large language models for generative AI, the FDA has yet to authorize a device that uses generative AI or that is powered by LLMs. 

The Takeaway

The FDA’s new report confirms that radiology AI shows no sign of slowing down, despite a drop in AI investment this year. 

The data also offer perspective on a JACR report last week predicting that by 2035 radiology could be seeing 350 new AI/ML product approvals for the year. Product approvals would only have to grow at about a 10% annual rate to hit that number – a figure that seems perfectly achievable given the new FDA report.

Economic Barriers to AI

Posted on by Brian Casey

A new article in JACR highlights the economic barriers that are limiting wider adoption of AI in healthcare in the US. The study paints a picture of how the complex nature of Medicare reimbursement puts the country at risk of falling behind other nations in the quest to implement healthcare AI on a national scale. 

The success of any new medical technology in the US has always been linked to whether physicians can get reimbursed for using it. But there are a variety of paths to reimbursement in the Medicare system, each one with its own rules and idiosyncrasies. 

The establishment of the NTAP program was thought to be a milestone in paying for AI for inpatients, for example, but the JACR authors note that NTAP payments are time-limited for no more than three years. A variety of other factors are limiting AI reimbursement, including … 

  • All of the AI payments approved under the NTAP program have expired, and as such no AI algorithm is being reimbursed under NTAP 
  • Budget-neutral requirements in the Medicare Physician Fee Schedule mean that AI reimbursement is often a zero-sum game. Payments made for one service (such as AI) must be offset by reductions for something else 
  • Only one imaging AI algorithm has successfully navigated CMS to achieve Category I reimbursement in the Physician Fee Schedule, starting in 2024 for fractional flow reserve (FFR) analysis

Standing in stark contrast to the Medicare system is the NHS in the UK, where regulators see AI as an invaluable tool to address chronic workforce shortages in radiology and are taking aggressive action to promote its adoption. Not only has NHS announced a £21M fund to fuel AI adoption, but it is mulling the implementation of a national platform to enable AI algorithms to be accessed within standard radiology workflow. 

The Takeaway

The JACR article illustrates how Medicare’s Byzantine reimbursement structure puts barriers in the path of wider AI adoption. Although there have been some reimbursement victories such as NTAP, these have been temporary, and the fact that only one radiology AI algorithm has achieved a Category I CPT code must be a sobering thought to AI proponents.

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