By Kurt Woock
On the one hand, the final decision from the Centers for Medicare and Medicaid Services (CMS) regarding reimbursement for beta-amyloid positron emission tomography (PET) for potential Alzheimer’s patients confirms that CMS sees that the emerging technology does hold promise. On the other hand, the final rule moves forward cautiously, citing a lack of evidence that demonstrates the test yields demonstrable improved patient outcomes. Two imaging organizations, the Medical Imaging & Technology Alliance (MITA) and the Society of Nuclear Medicine and Molecular Imaging (SNMMI), have released statements on the final rule, expressing optimism that the rule does moves the technology ahead but disappointment about the narrow confines under which the test can be reimbursed.
Under the final rule, CMS will cover one scan per patient in projects that fall under coverage with evidence development (CED). The only other way for patients to access the test, other than out-of-pocket, is through clinical trials. The difference between the final rule issued by CMS and the ideas put forward by outside groups lies in the definition of the subset of patients who can benefit from the test.
Neither plan prescribes that all patients with Alzheimer’s disease would receive the test. “The number of patients suffering from Alzheimer’s disease and dementia is a large population, and this is not an inexpensive technology,” said Satoshi Minoshima, MD, PhD, professor, vice chair, and research director in the neuroimaging and biotechnology laboratory, department of radiology at the University of Washington. Minoshima is also an SNMMI member and coauthor of SNMMI’s appropriate use criteria. “That’s one of the reasons the group developed appropriate use criteria with imaging and dementia experts. The test can help patients with atypical symptoms, where standard clinical diagnostics can’t bring a clear diagnoses.”
The percentage of patients who have dementia with atypical symptoms might be limited, said Minoshima, but nevertheless it is a population that SNMMI believes could benefit from the test. “A portion of the patients might be developing signs of the disease early on—those with mild cognitive impairment (MCI)—and SNMMI also wanted to include those with unexplained symptoms,” he said. The plan issued by CMS does not cover those cases. Minoshima added that a benefit of having access to the exam includes the possibility that it would help the patient avoid or stop taking drugs prescribed under a false diagnosis of AD, something the test can rule out. The prolonged use of non-effective drugs can be costly.
Because both the technology and the limited CMS coverage are new, Minoshima said it is difficult to estimate just how many people will receive the exam as well as how many more might have received it if it were available to additional people, such as those with MCI. The rules that will govern which studies meet the requirements for CED have not yet been issued.
Despite the technology’s rollout taking place at a slower pace than what SNMMI would have preferred, Minoshima said he expects CMS will eventually get the evidence it needs to make the test available for more patients. One change made in the final CMS decision that could bolster the test’s chances is the allowance of evidence of short-term outcomes. Because patients with Alzheimer’s disease often live for many years, proving long-term benefits can be more difficult compared to, for example, some types of cancer, where the data collection could occur in a shorter timeframe. “If we can do short-term outcome studies in the United States, we may be able to show the definitive value of the benefits in patient care sooner,” Minoshima said.
