Richard Wahl, MD, of Mallinckrodt Institute of Radiology at Washington University in St. Louis and past-president of SNMMI, on the CMS proposal to revise its policy on reimbursement of PET scans for Alzheimer’s disease.

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Brain Imaging

CMS May Shake Up PET Payments

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 Takeaway

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.

To Pay or Not to Pay for AI in Radiology

AI-supported digital applications are expected to transform radiology, but providers need motivation and incentives to adopt them. In this article, authors including executives from Bayer propose a framework to guide payers and AI developers in adoption of radiology AI.

A Technologists’ Guide to Cardiac CT Protocols

Interested in learning more on cardiac CT protocols? Hear from Luis Landeras, MD, and technologist Michael Mason from the University of Chicago as they share common challenges, clinical cases, and customized CT protocols they use with cardiac patients on their GE HealthCare Revolution Apex CT scanner.

The Wire

• Leqembi to Get Competition: In related news, the anti-Alzheimer’s therapy Leqembi may get some competition soon. Eli Lilly said it plans to file for FDA approval of its donanemab drug after reporting positive results in the phase 3 TRAILBLAZER-ALZ 2 trial at this week’s AAIC 2023 meeting. Like Leqembi, donanemab targets amyloid buildup in the brain, and will likely lead to increased PET use to identify suitable patients and guide treatment. Eli Lilly said it expects “regulatory action” on donanemab by the end of 2023.

• Medicare Payment Affects CTC Use: Medicare reimbursement policies may be limiting CT colonography (CTC) scans to more affluent individuals who can pay out of pocket. Unlike other colon cancer screening tests, CMS doesn’t pay for CTC, so in AJR researchers analyzed Medicare claims for 785k screening events from 2011 to 2020, finding that people living in wealthier communities had a higher odds ratio for CTC than other tests like optical colonoscopy or fecal tests (OR=5.73 vs. 1.36 vs. 1.50, respectively). 

• ViewRay Files for Chapter 11: Radiation therapy developer ViewRay has filed for Chapter 11 bankruptcy protection and plans to sell all or part of its assets. The company also saw CEO Scott Drake and several board members resign. ViewRay’s flagship product is the MRIdian MRI-guided radiation therapy system, which it believes offers advantages over other forms of image-guided radiation therapy. But ViewRay recorded revenue from only three system sales in its Q1 2023 on its way to posting a $28.9M net loss. 

• Radiologists As AI Vendors: Radiologists who join AI vendors can help spur the adoption of artificial intelligence in the specialty. So says a new paper in JACR co-authored by several AI heavyweights. The article lists the benefits that radiologists bring to AI vendors, such as clinical domain expertise, knowledge of radiology workflow and clinical challenges, and strong customer relationships. It also offers advice for imaging specialists who might be interested in vendor employment.

• Signify Pegs Value of AI Market: Signify Research estimates that the medical imaging AI market was valued at $576M in 2022, an increase of 15% compared to 2021. Signify projects the market to grow to $1.73B by 2027, representing aggregate growth of 25% across the forecast period. Sales of medical imaging AI are in four main segments: cardiology ($192M), neurology ($159M), pulmonology ($88M), and breast imaging ($69M). Despite the growth, Signify notes that AI still faces clinical adoption challenges, and venture capital firms are becoming more discerning. 

• Half-Dose Gadopiclenol Measures Up: MRI scans conducted at a half-dose (0.05 mmol/kg) of the gadopiclenol high-relaxivity gadolinium-based contrast agent were comparable to those using a full dose (0.1 mmol/kg) of gadobutrol. In the PROMISE study published in Radiology, researchers at 33 centers in 11 countries compared image quality in 260 scans with gadopiclenol and gadobutrol. The half-dose gadopiclenol scans were comparable and had a similar safety profile. The FDA approved gadopiclenol in September 2022; it is marketed as Elucirem by Guerbet and Vueway by Bracco. 

• MRI Safety Exam Goes Electronic: The American Board of Magnetic Resonance Safety (ABMRS) is moving to administer its credentialing exam electronically. Starting this summer, exam candidates in the US and Canada will take the test at centers operated by Prometric, which runs 350 testing centers in North America. ABMRS will roll out electronic testing to the UK and other countries shortly thereafter. 

• Does Private Equity Harm Patients? A new study in The BMJ suggests that private equity ownership of healthcare services can have a harmful impact on cost and quality of care. Researchers performed a meta-analysis of 55 studies (47 US-focused) over the past 20 years, most analyzing PE investment in nursing homes. Nine of 12 studies showed higher costs to patients or payers, while of the 27 studies that assessed care quality, 12 found harmful impacts, three found beneficial impacts, nine found mixed impacts, and three were neutral. 

• Riverain Notches H1 Milestones: Riverain Technologies has achieved several milestones in the first half of 2023. The company said its ClearRead solutions with Clear Visual Intelligence (CVI) technology are now being used by radiologists in 15 countries. Riverain also saw revenue grow 263% and its workforce increase 25% compared to the first half of 2022. New customers include UC San Diego (UCSD), Cedar-Sinai Health System, and the University of New Mexico Health System, as well as several VA medical centers.

• FDA Clears MediView Surgical AR: The FDA has cleared MediView XR’s XR90 augmented reality surgical navigation system for guiding minimally invasive procedures for soft tissue and bone. XR90 overlays colorized 3D MRI or CT images of patient anatomy to provide holographic navigation during surgeries. MedView recently raised $15M in a funding round, and also is working with GE HealthCare on the OmnifyXR Interventional Suite to support IR visualization and remote collaboration.

• iCAD Lands Radiology Partners: iCAD has signed a partnership to provide its breast AI technology to Radiology Partners. iCAD applications including its ProFound solution will be offered through the Radiology Partners Cloud; RP offers mammography services across more than 3.2k facilities, including 17 of the 20 largest US health systems. The deal is a shot in the arm for iCAD, which in March implemented a restructuring plan that included laying off 28% of its workforce.

• Medality Renews Kansas Client: Practice development platform Medality has renewed and expanded its partnership with the University of Kansas School of Medicine-Wichita. Medality provides online education and upskilling services to radiology practices, and recently issued a report finding that many radiologists are still reading a wide range of modalities.

What Is CPACS in Cardiology?

What is CPACS in Cardiology? It stands for Cardiovascular Picture Archive and Communication System, and it’s used to store, manage, and share cardiology images. Learn how CPACS can improve patient care in this Intelerad blog post.

Faster PET Scans with SubtlePET

Want to perform PET scans faster, but keep the same image quality? With SubtlePET image enhancement from Subtle Medical, you can conduct PET exams in one-quarter of the original time while preserving image quality. Find out how in this case review.

Annalise.ai’s AI Confidence Bar

Curious how certain your AI is about its own finding? Annalise.ai’s confidence bar displays the likelihood of each finding and the AI model’s level of certainty, helping clinicians perform their interpretations with greater confidence.

The Resource Wire

• The right hanging protocol can dramatically reduce radiologist reporting time. But how can you get the best hanging protocols for your radiologists? Learn how it’s done – and find out how Curie|ENDEX can help – in this white paper from Enlitic. 

• Medical providers and health systems are looking to ditch the disc and modernize their patients’ journey. Learn how Clearpath helps them reduce the cost of retrieving and fulfilling patient requests for imaging and medical records.

• See what UC Davis has to say about United Imaging’s EXPLORER Total Body Scanner, the first whole-body PET.

• What’s the latest news from Merge by Merative? Get an update on the company’s activities in enterprise imaging, VNA and viewers, workflow orchestration, and radiology departmental solutions from General Manager Ashish Sant in this interview from SIIM 2023. 

• After setting ambitious regulatory and commercialization goals, Lunit leveraged CARPL.ai’s platform and operational guidance to complete the clinical trials needed for its INSIGHT CXR and MMG AI tools’ FDA clearances.

• Is your in-office MRI service prepared for the future? See how three macro trends will impact your in-office orthopedic MRI service, and the MRI capabilities you’ll need in the future, in this Siemens Healthineers report.

• Did you know there are four main indicators that show informed patients have better clinical outcomes? Check out this analysis from PocketHealth on why empowered patients make better patients. 

• This Riverain Technologies case study details how the University of Colorado Hospital enhanced its chest X-ray workflow with ClearRead Bone Suppress, which can improve the visibility and detection of focal lung densities, including nodules.

• Radiology faces numerous challenges to more efficient workflow, from the siloed nature of healthcare enterprises to mundane tasks that are ripe for automation. In this Imaging Wire Show, we talked to Matthew Lungren, MD, and Calum Cunningham of Nuance Communications.

• In a new research study in Clinical Imaging, see how Visage Imaging’s PACS-integrated Visage Breast Density application had high accuracy and agreement with radiologist assessments for classifying mammography exams into BI-RADS categories.

• Today’s employment environment in radiology has never been more challenging. But there are tools you can use to keep your radiologists happy and engaged, according to this white paper from Medality. 

• Check out this Imaging Wire Show featuring Us2.ai’s co-founders – James Hare and Dr. Carolyn Lam – for a great discussion about Us2.ai’s continued clinical and commercial expansion, and their efforts to improve echocardiography accuracy, efficiency, and accessibility.

• Creating your AI adoption plan? This Arterys report details what clinical, efficiency, and regulatory factors to look for in radiology AI vendors.

• Despite significant interest, there’s still confusion about the value of imaging AI. This Blackford Analysis white paper explores the key cost considerations and ROI factors that radiology groups can use to figure out how to make AI valuable for them.

• Imaging’s cloud evolution didn’t happen all at once. This Change Healthcare animation details the history of digital imaging architectures, and how cloud-native imaging improves stability and scalability, ease of management, patient data security, and operating costs.