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  • The lifetime limit is “outdated” and “not clinically appropriate” given the need for PET for both patient selection and to potentially discontinue treatment if it’s ineffective or if it’s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.

Incidental Evolution

Last week brought a wave of studies that either highlighted how findings in common imaging exams could add value in completely different clinical areas, or showed how incidentals could find a home in established clinical workflows. That might not be welcomed news among the many radiologists who view incidentals as a clinical slippery slope, but it’s another sign that the incidental evolution is gaining momentum.

Left Atrial Dementia Marker – A new JAMA study showed that echocardiographic left atrial function measurements can be used to identify individuals with higher dementia risks, in addition to supporting cardiovascular diagnosis. Analysis of 4,096 participants’ echo exams and 6-year outcomes (75yr avg. age; 531 developed dementia) revealed that lower left atrial function (e.g. reservoir strain, conduit strain, contractile strain, active emptying fraction, emptying fraction) has a statistically significant association with developing dementia (1.43 to 1.98 hazard ratios).

BACs and CVD – A Kaiser Permanente study added more evidence supporting breast arterial calcifications’ value as a cardiovascular disease risk factor. The researchers analyzed 5,059 women’s digital mammography exams (26.5% w/ BACs), finding that women with BACs had a 51% higher risk of developing atherosclerotic CVD and a 23% higher risk of developing any type of CVD over 6.5-years. This is far from the first study to tie BACs to CVD risk, but it came with a high level of credibility (large/observational study, published on Circulation) and generated quite a bit of media attention.

Auto CAC Pathway – A Journal of Digital Imaging study highlighted how coronary artery calcium scores (CAC scores) could be integrated into standard cardiovascular disease (CVD) risk systems, potentially streamlining CAC AI adoption. The researchers used an FDA-cleared AI model (believed to be from Nanox AI) to screen 14,135 patients’ existing CTs (470 who experienced CVD within 5yrs) and then combined their CAC scores with the ACC/AHA’s PCE risk system. The AI-augmented PCE predictions outperformed standard PCE predictions (sensitivity: 57% vs. 53%; specificity: 70% vs. 67%), without requiring additional scans or diagnostic workflows.

Northwestern Follows-Up – A new NEJM study highlighted the impressive results of Northwestern Medicine’s lung nodule follow-up system, which uses NLP to identify suspicious nodules and then initiates a follow-up workflow (prompts physicians, notifies patients, tracks follow-ups). Over 13 months, the system screened over 570k imaging studies, flagging 29k exams for follow-up (77.1% sensitivity, 99.5% specificity, 90.3% PPV), and tracked over 2,400 follow-ups to completion.

The Takeaway
Last week’s batch of studies serve as yet another reminder that common imaging exams could serve broader clinical roles the future, either by creating new risk-based incidental pathways (LA function for dementia; BAC for CVD), catching more undetected incidentals (AI CAC scoring), or by formalizing how incidentals are brought into clinical pathways (e.g. adding CAC to PCEs; leveraging NLP for follow-ups).

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