ACR urges radiologists to speak up as Medicare considers covering imaging AI software

The American College of Radiology is asking the specialty to speak up as the Centers for Medicare & Medicaid Services considers whether to cover an imaging artificial intelligence solution.

New York-based vendor Cleerly recently petitioned CMS to pay for its primary CT software, which assesses scans for signs of coronary artery disease. Five of the seven Medicare Administrative Contractors have now launched local coverage determinations and are accepting feedback from the public until mid-July.

“ACR urges members who perform this procedure to engage with the MACs during the public comment period,” the college said in a June 5 news update. “Physicians and subject matter experts have an opportunity to help improve the clinical indications section and related ICD-10-CM diagnosis codes.”

The proposed local coverage determination pertains to AI-enabled, CT-based quantitative coronary tomography/coronary plaque analysis. Providers have the potential to earn Medicare payment when the software is deployed in medically appropriate scenarios. These could include when an individual is eligible for coronary CT angiography, presents with a acute chest pain and no known coronary artery disease, and is classified as intermediate risk. They also must have produced a negative or inconclusive screening test for acute coronary syndrome, ACR noted.

“Ideally, the LCD would include language stating that patients not only with acute chest pain but also stable chest pain are eligible for AI-QCT/AI-CPA,” Pamela Woodard, MD, ACR president, said in the same announcement. “Patients with stable angina would most benefit from this technology and the lack of inclusion of stable angina patients may have been an oversight.”

Potential coverage comes with other caveats. Supervision, interpretation and reporting must be performed by a physician with advanced training in CCTA and related radiological exams. The AI tool is not meant to replace the assessment of a qualified provider, ACR emphasized.

In its April 2023 request to CMS, Cleerly noted that— when applying its CT AI in referral management to avoid invasive coronary angiography—it produced considerable savings. Doing so in patients with less than 50% stenosis (i.e., nonobstructive disease), costs were reduced by 26%. This impact was calculated using the Cleerly list price of $1,500. When using the newly assigned ambulatory payment classification at $950, the cost savings would grow to 46%.

“Overall, the evidence detailed above demonstrates not only the accuracy, sensitivity and specificity of AI-QCT compared to [quantitative coronary angiography] as a reference of care, but also its advantages over CCTA alone, over stress [myocardial perfusion imaging], and its potential to reduce downstream unnecessary invasive procedures when sequenced appropriately,” noted Lance Thrash, RN, VP of market access and reimbursement at Cleerly Labs.

You can find further details about how to submit feedback in ACR’s news post. MACs considering coverage include WPS, Palmetto, Noridian, National Government Services Inc. and CGS Administrators. The potential policy change also would apply to Plaque Analysis software from imaging vendor HeartFlow. Leaders at the Mountain View, California-based company called the initiation of this review process a "milestone towards Medicare coverage." 

“This recognition by the MACs in the draft policies is a testament to the clinical value of Plaque Analysis and its potential to revolutionize how cardiovascular disease is diagnosed and treated, for all," CEO John Farquhar said in a June 3 announcement

Editor's Note: This story has been updated to include a comment from HeartFlow.

Marty Stempniak

Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic. 

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