It’s no secret that insurance reimbursement drives adoption of new medical technology. But a new analysis in NEJM AI shows exactly how reimbursement is affecting the diffusion into clinical practice of perhaps the newest medical technology – artificial intelligence.
Researchers analyzed a database of over 11B CPT claims from January 2018 to June 2023 to find out how often reimbursement claims are being submitted for the use of the over 500 AI devices that had been approved by the FDA at the time the paper was finalized.
- The authors chose to focus on CPT claims rather than claims under the NTAP program for new technologies because CPT codes are used by both public and private payors in inpatient and outpatient settings, while NTAP only applies to Medicare inpatient payments.
They found 16 medical AI procedures billable under CPT codes; of these, 15 codes were created since 2021 and the median age of a CPT code was about 374 days, indicating the novelty of medical AI.
- Also, only four of the 16 had more than 1k claims submitted, leading the authors to state “overall utilization of medical AI products is still limited and focused on a few leading procedures,” such as coronary artery disease and diabetic retinopathy.
The top 10 AI products and number of CPT claims submitted are as follows:
- HeartFlow Analysis for coronary artery disease (67,306)
- LumineticsCore for diabetic retinopathy (15,097)
- Cleerly for coronary atherosclerosis (4,459)
- Perspectum LiverMultiScan for liver MRI (2,428)
- Perspectum CoverScan for multiorgan MRI (591)
- Koios DS for breast ultrasound (552)
- Anumana for ECG cardiac dysfunction (435)
- CADScor for cardiac acoustic waveform recording (331)
- Perspectum MRCP for quantitative MR cholangiopancreatography (237)
- CompuFlo for epidural infusion (67)
While radiology may rule in terms of the sheer number of FDA-approved AI products (79% in a recent analysis), the list shows that cardiology is king when it comes to paying the bills.
Amid the breathless hype around medical AI, the NEJM AI study comes as a bit of a wake-up call, showing how the cold reality of healthcare economics can limit technology diffusion – a finding also indicated in other studies of economic barriers to AI.
On the positive side, it shows that a rosy future lies ahead for those AI algorithms – like HeartFlow Analysis – that can make the leap.
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 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.
In a major victory for PET advocates, CMS this week said it was opening a review of its reimbursement policy on PET scans for Alzheimer’s disease. The review could lead to more generous Medicare and Medicaid payments for PET to detect amyloid buildup in the brain, long known as a link to the debilitating – and inevitably fatal – disease.
Medicare’s current policy on PET for Alzheimer’s has been in place since 2013 and is based on its coverage with evidence (CED) framework; it restricts reimbursement to a single scan per lifetime for patients who must be participating in clinical trials. The CED policy reflects not only CMS’ cautious approach to new technology, but also the fact that for years there have been no effective treatments for Alzheimer’s disease.
That’s all changed within the last year. A new class of drugs that target amyloid buildup in the brain has begun to receive FDA approval, the most recent being Leqembi from Esai/Biogen in January 2023. And this week, Eli Lilly reported positive results for its amyloid-targeting treatment donanemab (see below), with approval expected by the end of 2023.
The new drugs have changed the game when it comes to diagnosis and treatment of Alzheimer’s disease:
- PET can now be used to identify eligible patients and monitor their treatment
- Thanks to PET, patients won’t continue to be given expensive drugs after amyloid buildup has been eliminated
- Expanded PET reimbursement could boost the use of PET diagnostic tracers for identifying amyloid buildup
CMS is taking comments on its proposal through August 16. If the agency eliminates the CED policy in favor of a national coverage decision, then decisions on PET reimbursement will be made by local Medicare Administrative Contractors (MACs).
This week’s news could be a Pyrrhic victory if PET reimbursement levels are set too low. One positive sign is that CMS has said it also plans to review its policy that bundles radiotracer payments together with scan payments, which tends to depress reimbursement.
The nuclear medicine and molecular imaging community has chafed for years under CMS’ restrictive policies on PET for Alzheimer’s disease, with groups like SNMMI lobbying for the change. This week’s news should have wide-ranging benefits not only for the PET business sector, but also for patients who are facing the scourge of Alzheimer’s disease.