Medicare coverage for amyloid brain imaging should be severely limited, according to a proposed decision released on July 8. The federal health program proposes to cover one scan per patient only as part of a clinical study or to rule out Alzheimer's disease in narrowly defined and clinically difficult differential diagnoses. The procedure is not “reasonable and necessary” otherwise, according to Medicare, because data are insufficient to support the conclusion that beta-amyloid imaging with PET improves outcomes for patients with Alzheimer’s disease.
The Centers for Medicare and Medicaid Services (CMS) proposes to cover the procedure under its Coverage with Evidence Development (CED) program, which provides coverage while collecting additional data on outcomes. Coverage under CED contributes to a new technology’s developmental pathway by encouraging more studies that use it, according to CMS.
Under the draft proposal, PET amyloid imaging would be covered only in CMS-approved, prospective, randomized trials that include subjects from appropriate populations and, when appropriate, use the gold standard of postmortem Alzheimer’s diagnosis. Study populations must include Medicare beneficiaries with cognitive impairment suggestive of Alzheimer’s disease or individuals who may be at risk for the disease.
Furthermore, studies must address at least one of a group of specified questions. One of these questions is whether PET amyloid imaging leads to improved health outcomes, including the avoidance of futile treatment or tests, improvement in or slowed decline of quality of life, and survival. A second question is whether treatment guided by PET amyloid imaging identifies specific subpopulations, patient characteristics, or differential diagnoses that predict improved health outcomes. Investigators also may assess whether PET amyloid imaging enriches the patient populations of Alzheimer’s trials by selecting patients on the basis of biologic as well as clinical and epidemiologic factors, and whether this enrichment leads to improved health outcomes.
The payment structure will be reconsidered after another evidence review at an unspecified future time, according to CMS.
Patient Advocates and Drug Companies Respond
The draft decision is a disappointment for patients and drug companies that are developing amyloid imaging agents. Past CED programs have taken as long as seven years to gather enough evidence for a federal payment reevaluation, according to a statement issued by the Alzheimer’s Association.
“Neither families directly impacted by the disease nor our federal government can afford to wait as much as seven years for a final decision about national coverage, as was the case with the National Oncology Patient Registry and the evaluation by CMS of FDG PET coverage,” stated the association. “The timeframe at which CMS has conducted CED processes is wholly unsuited and unacceptable to both the pace of scientific and technologic innovation in the Alzheimer’s field and, more importantly, the rapidly increasing needs posed by the escalating Alzheimer’s epidemic. If the federal government follows this example and timeline, it will hinder coverage of a badly needed, already FDA-approved diagnostic tool in limited populations in which sufficient evidence indicates this technology has meaningful impact.”
Avid Radiopharmaceuticals, which manufactures the imaging agent florbetapir F-18 injection, agreed. “CMS appears to be challenging the value of an adjunctive tool that can assist physicians in making a more informed diagnosis for patients with cognitive impairment,” said Daniel Skovronsky, MD, PhD, the company’s founder and CEO. “Restricting coverage could hinder a timely and accurate diagnosis, which is in conflict with the advice of Alzheimer’s disease experts and with the administration’s National Alzheimer’s Project Act.”
Revised Appropriate Use Criteria May Help Additional Patients
Last January, the Alzheimer’s Association and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) issued revised appropriate use criteria for imaging agents. Imaging should be reserved for patients with persistent or progressive unexplained mild cognitive impairment (MCI), MCI that has an atypical presentation, and MCI that develops at an atypically young age, according to the criteria. Imaging is not appropriate for asymptomatic patients, for patients with typical-onset dementia, as a substitute for risk genotyping in patients with a family history, or to determine dementia severity, according to the criteria.
The SNMMI criteria address a small but important patient population not included under the CMS proposed payment scheme, said Richard J. Caselli, MD, Professor of Neurology at the Mayo Clinic in Scottsdale, Arizona. “While I can understand the rationale for not reimbursing this [test] in the typical elderly dementia patient, there is another population, albeit smaller, that would clearly benefit: the working patient,” he said in an interview. “Imagine a 52-year-old man with no family history [of dementia] who starts developing memory loss, has trouble on the job as a result, and seeks help. In this case, a diagnosis of Alzheimer’s is unexpected, and will result in disability.”