SNMMI President Helen Nadel, MD, on the decision by CMS to end restrictions on PET reimbursement for Alzheimer’s disease patients.

Lung pathologies are commonplace and have a growing burden on society. Meanwhile, medical imaging technologies that rely on structural images have shortcomings in diagnosing lung diseases. In this episode of the Imaging Wire Show, we talked to Andreas Fouras, PhD, and Greg Mogel, MD, of 4DMedical about their technology for functional lung imaging.

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Brain Imaging

PET’s Milestone Moment

In a milestone moment for PET, CMS has ended its policy of only paying for PET scans of dementia patients if they are enrolled in a clinical trial. The move paves the way for broader use of PET for conditions like Alzheimer’s disease as new diagnostic and therapeutic agents become available. 

CMS said it was rescinding its coverage with evidence development (CED) requirement for PET payments within Medicare and Medicaid. 

• Advocates for PET have chafed at the policy since it was established in 2013, claiming that it restricted use of PET to detect buildup of amyloid and tau in the brain – widely considered to be precursors to Alzheimer’s disease. The policy limits PET payments to one scan per lifetime for patients enrolled in clinical trials. 

But the landscape began changing with the arrival of new Alzheimer’s treatments like Leqembi, approved in January 2023. CMS telegraphed its changing position in July, when it announced a review of the CED policy, and followed through with the change on October 13. The new policy…

• Eliminates the requirement that patients be enrolled in clinical trials
• Ends the limit of one PET scan per Alzheimer’s patient per lifetime
• Allows Medicare Administrative Contractors (MACs) to make coverage decisions on Alzheimer’s PET
• Rejects requests to have the policy applied retroactively, such as to when Leqembi was approved

CMS specifically cited the introduction of new anti-amyloid treatments as one of the reasons behind its change in policy. 

• The lifetime limit is “outdated” and “not clinically appropriate” given the need for PET for both patient selection and to potentially discontinue treatment if it’s ineffective or if it’s worked to clear amyloid from the brain – a key need for such expensive therapies. 

The news was quickly applauded by groups like SNMMI and MITA, which have long advocated for looser reimbursement rules.

The Takeaway

The CMS decision is great news for the PET community as well as for patients facing a diagnosis of Alzheimer’s disease. The question remains as to what sort of reimbursement rates providers will see from the various MACs around the US, and whether commercial payers will follow suit.

AI and Change Management in Radiology

Join industry experts in this October 18 webinar from Bayer as they provide insight on streamlining radiology’s transition to AI, including addressing resistance to change and optimizing AI’s potential to impact patient care.

Real patients. Real stories.

Meet the women who inspire GE HealthCare to keep pushing for progress and pioneering mammography technology that improves health and can save lives. Hear their stories in these videos.

The Wire

• Gadopiclenol Advances in Europe: Guerbet and Bracco have received positive opinions from European regulatory authorities for their formulations of gadopiclenol, a new high-relaxivity MRI contrast agent. Studies have shown that gadopiclenol can be used at half the dose of conventional MRI contrast with the same image quality. Guerbet and Bracco co-developed gadopiclenol, with each company marketing it under their own branding, Guerbet as Elucirem and Bracco as Vueway. The companies won US approvals in September 2022; final European approvals should come by the end of 2023. 

• Autonomous AI for Radiology: What is autonomous AI, and is radiology ready for this new technology? A new article from Oxipit explores autonomous AI and some of the exciting applications that are becoming available to radiologists, such as reviewing large volumes of chest X-rays to screen out exams that have a high likelihood of being normal. This enables radiologists to focus on studies most likely to have abnormalities, saving time in an era of workforce shortages.  

• Vuno Gets First FDA Clearance: South Korean AI developer Vuno has received its first FDA clearance, for its Vuno Med-DeepBrain algorithm. The solution analyzes brain MRI scans to produce quantitative measurements of brain atrophy, which can help diagnose degenerative brain diseases like Alzheimer’s. The algorithm will be the centerpiece of Vuno’s entry into the US, which the company sees as timely given recent approvals of Alzheimer’s drugs. In addition to neuroimaging, Vuno has partnered with Mayo Clinic to jointly develop and evaluate AI-based cancer biomarkers.

• 3T MRI Predicts Stroke Recurrence: In a study from China, researchers found that 3T MRI can be used to predict stroke recurrence by measuring the enhancement of atherosclerotic plaques. In a study of 78 patients in Journal of Stroke and Cerebrovascular Diseases, researchers found that those with high plaque enhancement on 3T MRI had over 10 times the risk of an ischemic event within 12 months of discharge (hazard ratio=10.5). The degree of plaque enhancement correlated with the degree of stenosis. 

• MRI+US for Non-Mass Breast Lesions: Is breast MRI or ultrasound better for working up non-mass-like lesions detected on breast ultrasound? How about both together? In Ultrasound in Medicine & Biology, researchers from China compared both modalities independently and together in a validation set of 61 women from 2017 to 2021. They found that US+MRI yielded higher performance as measured by AUC (0.90) compared to ultrasound (0.73) or MRI (0.84). Better differentiation of these lesions on imaging could help avoid unnecessary biopsies. 

• $44M Contract for AI-Based POCUS: GE HealthCare has won a $44M contract from the US government’s Biomedical Advanced Research and Development Authority (BARDA) to develop next-generation POCUS scanners with new AI-based applications. GE will build on its existing POCUS technology to develop an advanced probe and scanner that will use AI guidance to make it easier for users to acquire exams, particularly for trauma triage and treatment. GE recently added Caption Guidance for cardiac imaging to its Venue family of POCUS scanners. 

• CAC+CCTA=Better CAD Diagnosis: Adding coronary artery calcium (CAC) scores to CCTA images improves diagnosis of coronary artery disease (CAD). In European Radiology, researchers performed a meta-analysis from 29 studies that compared CCTA alone to CCTA+CAC of 2.3k patients with suspected CAD and stable chest pain. The combined technique had higher accuracy by AUC (87% vs. 80%), and its advantage persisted regardless of age, gender, or type of chest pain. The findings could contribute to better choice of treatment options. 

• Envision to Exit Bankruptcy: National medical group Envision Healthcare is set to exit Chapter 11 bankruptcy proceedings after a judge approved its reorganization plan. The plan will eliminate 70% of the company’s debt, while spinning off its AMSURG ambulatory surgery business into an independent company. Envision filed for bankruptcy in May in a move that some said indicated the downside of private equity’s investment in healthcare. 

• Lung Cancer’s Burden Growing in Women: It’s common knowledge that lung cancer incidence rates have been dropping, but men are seeing a steeper decline than women, such that incidence rates in women are nearly equal to men, says a research letter in JAMA Oncology based on 2000-2019 data. The female-to-male incidence rate ratio grew in people aged 50-54 (0.73 to 1.05) and in those aged 70-74 (0.62 to 0.81). Researchers recommended women be targeted with smoking cessation and lung screening, which has been shown to save women’s lives.

• UK’s Big Total-Body PET Project: The UK has made a huge £32M ($39M) investment to set up two total-body PET centers, in London and Scotland. The National PET Imaging Platform (NPIP) is designed to further both research and clinical care using Siemens Healthineers’ Biograph Vision Quadra PET/CT scanners, which have 40 times the sensitivity of conventional PET scanners. The centers are expected to be operational in April 2024. 

• Paragon Links with Claritas: Software developer Claritas HealthTech and consulting firm Paragon Health IT have inked a global partnership to provide imaging centers with a single unified platform for AI and data services. Claritas will provide its AI and image processing tools like iRAD and iPET with Paragon’s Strings data analytics application, which gives healthcare providers insights into their use of enterprise imaging software. 

• Published Papers Produce Speaker Spam: There can be a downside to being a successful academic researcher. A new study in Current Problems in Diagnostic Radiology shows that more prolific researchers also got more unsolicited invitations to speak at “questionable” medical meetings – invitations that are a new form of phishing. In a study of 188 “inappropriate” speaker invitation emails sent to 45 faculty members, those with more than 10 publications since 2022 had a 5X higher odds of getting more than four invitations.

A Tactical Approach to Leadership Success

Learn new strategies for achieving leadership success in this October 18 RadEqual webinar sponsored by Intelerad and the American Association for Women in Radiology, and featuring Geraldine McGinty, MD, and Melissa Davis, MD.

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.

The Resource Wire

• See how adopting ClearRead CT allowed Michigan’s Regional Medical Imaging’s radiologists to complete their chest CT reads faster and more accurately in this Riverain Technologies case study.

• Trying to decide between public and private cloud? Watch this brief Change Healthcare animation detailing the operational benefits of public cloud hosting for imaging.

• Imaging AI is evolving fast, but radiology leaders’ expectations for their AI technologies might be evolving even faster. In this Imaging Wire Show with Dr. Charlene Liew of SingHealth and Dr. Nina Kottler of Radiology Partners, we explore radiology leaders’ current and future expectations for AI, and the central role platforms play in their AI roadmaps.

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

• Learn how a redesigned enterprise image exchange can enhance patient experiences, improve population health, generate cost savings and increase staff satisfaction in this white paper from PocketHealth.

• Join Merge on October 19 for a conversation on how to provide better patient outcomes and user experiences in mammography. Hear from thought leaders on the development and deployment of breast imaging solutions driven by patient needs.

• How is Clearpath improving the healthcare experience for patients? Learn more about the company and its solutions for ditching the disc when sharing images and records with patients. 

• A major hurdle facing AI orchestration is the lack of standardized data. In this article from Enlitic, learn about the importance of data standardization and how it can revolutionize the way you harness the power of AI.

• How can your imaging facility create a foundation for MRI safety? Learn from MRI safety expert Tobias Gilk on the best practices for creating a safe environment in this podcast with Medality. 

• What’s happening at the intersection of AI and precision medicine? In this Imaging Wire Show, we talked to Chiranjiv Singh, general manager at Tempus Radiology, about their vision for building a 360° view of the patient.

• Learn about the power of the platform to deliver multiple AI solutions in this October 26 webinar sponsored by Nuance. Discover how to optimize your existing data with AI to get more out of routine imaging.

• CloudPACS has finally arrived. Learn more about the benefits that cloud-based PACS can have for your radiology practice and how Visage Imaging’s Visage 7 was built from the ground up to ensure maximum performance, security, and scale. 

• True time-of-flight (TOF) PET/CT based on lutetium oxyorthosilicate (LSO) detectors offers numerous clinical advantages, such as better definition of small lesions and improved uniformity. Learn the other advantages in this article from Siemens Healthineers. 

• Learn about how Us2.ai is bringing simplicity and clarity to the world of echo AI and cardiac ultrasound on the latest episode of The Bleeding Edge of Digital Health featuring Us2.ai’s founders, James Hare and Carolyn Lam, MD. 

• Trying to figure out how your IT resources can handle increased AI adoption? This Blackford paper details how the cloud is helping radiology organizations scale their computing resources to support multiple AI applications or algorithms.