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.
Over one-quarter of patients presenting with a first episode of psychosis had some kind of abnormality on brain MRI scans, and about 6% of all findings were clinically relevant and required a change in patient management. Writing in JAMA Psychiatry, researchers from the UK and Germany say their study suggests that MRI should be used in the clinical workup of all patients presenting with psychosis.
Psychosis caused by another medical condition – called secondary psychosis – can have causes that produce brain abnormalities visible on MRI scans. These are findings like white-matter hyperintensities that – while not themselves a form of pathology – are sometimes associated with more serious conditions like cognitive decline.
MRI scans of people experiencing their first psychotic episode could detect some of these abnormalities before subsequent episodes occur. But at present there is no consensus as to whether MRI should be used in the evaluation of patients presenting with first-episode psychosis.
In a meta-analysis, researchers wanted to investigate the prevalence of intracranial radiological abnormalities on MRI scans of patients with first-episode psychosis. They reviewed 12 independent studies that covered a total of 1,613 patients. Findings across all the studies included:
- A prevalence rate of 26.4% for all radiological abnormalities
- A prevalence rate of 5.9% for clinically relevant abnormalities
- One in 18 patients had a change in management after an MRI scan
- White-matter hyperintensities were the most common abnormality, with a prevalence of 7.9% for all abnormalities and 0.9% among clinically relevant abnormalities
Given the impact of MRI on patient management, the authors suggested that performing routine scans on people after their first psychotic episode could have both clinical and economic benefits. This could be especially true due to the financial costs of failing to identify a clinically relevant abnormality that could lead to a later episode if not treated.
These findings may break the logjam over whether MRI should be routinely used in the evaluation of patients with first-episode psychosis. The authors note that while many of the abnormalities found on MRI in the studies they reviewed did not require a change in patient management, abnormalities could be harbingers of poorer patient outcomes, even if they don’t eventually lead to a diagnosis of secondary psychosis.
A new study in AJR calculates the cost to patients when imaging evaluation is incomplete, finding that people with transient ischemic attack (TIA) who didn’t get full imaging workups were 30% more likely to have a new stroke diagnosis within the next 90 days.
Some 240,000 people experience TIA annually in the US. While TIAs typically last only a few minutes and don’t cause lasting neurological damage, they can be a warning sign of future neurological events to come.
Medical imaging – typically CT and MRI – are key in the neurological workup of TIA patients, and TIA can be treated with antithrombotic therapy, which reduces the likelihood of a stroke 90 days later. Therefore, guidelines call for prompt neuroimaging of the brain and neck in TIA patients, typically within 48 hours, with MRI the primary and CT the secondary options.
But what happens if TIA patients don’t get complete imaging as part of their workup? To answer this question, researchers from Colorado and California analyzed a database of 111,417 people seen at 4,253 hospitals who presented to the ED with TIA symptoms from 2016 to 2017.
They tracked which patients received complete neurovascular imaging within 48 hours as part of their workup, then followed how many received a primary diagnosis of stroke within 90 days of the initial TIA encounter. Findings included:
- 62.7% of patients received brain imaging and complete neurovascular imaging (both head and neck) within 48 hours
- 37.3% received brain imaging but incomplete neurovascular imaging
- There was a higher rate of stroke at 90 days in TIA patients with incomplete imaging workup (7.0% vs. 4.4%)
- Patients with incomplete neurovascular imaging also had a greater chance of stroke at 90 days (OR=1.3)
While the benefits of neuroimaging for stroke have been demonstrated in the literature, imaging’s value for TIA has been less certain – until now. The AJR study shows that neuroimaging is just as vital for TIA workup, and it supports guidelines calling for cross-sectional imaging of the head and neck within 48 hours of TIA.