The Medical Imaging & Technology Alliance (MITA) today said that the Centers for Medicare & Medicaid Services’ (CMS) draft decision proposing Coverage with Evidence Development (CED) for the use of beta amyloid positron emission tomography (PET) imaging falls short of providing Medicare beneficiaries with suspected dementia or Alzheimer’s Disease (AD) appropriate access to this ground-breaking diagnostic technology.
“We are encouraged by CMS’ acknowledgement that beta amyloid PET can exclude the possibility of Alzheimer’s disease”, said Gail Rodriguez, Executive Director of MITA. “However, we are concerned that CMS considers the existing evidence inadequate for coverage for all Medicare beneficiaries.”
CMS proposes to cover one PET beta amyloid scan per patient and only if the patient is enrolled in a CMS-approved clinical trial. Though CMS cites sufficient evidence that the use of beta amyloid PET imaging has the potential to exclude AD, the coverage decision limits this population to “narrowly defined and clinically difficult differential diagnoses” to develop treatment or prevention strategies for AD.
Beta amyloid PET imaging can detect the presence of plaques which are indicative of AD and help physicians diagnose patients earlier. Additionally, the ability to rule out AD could help physicians avoid inappropriate and unnecessary treatments. Beta amyloid PET imaging is the only alternative to autopsy to confirm the presence or absence of beta amyloid in the brain.
“CMS’ proposed rule states that more evidence is required to conclude that the imaging procedure is appropriate,” said Rodriguez. “We believe the Appropriate Use Criteria, and the clinical evidence used to support them, are sufficient. These criteria were developed by a taskforce of experts from the Alzheimer’s Association and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) to aid in the diagnosis of people with suspected AD.
“We are hopeful CMS will continue to evaluate the vigorous evidence that supports the use of beta amyloid PET and adopt the Appropriate Use Criteria to guide physician utilization of amyloid PET imaging,” said Rodriguez. “MITA has long supported Medicare coverage decisions that facilitate access to PET imaging, which has revolutionized the diagnosis, treatment and monitoring of a wide range of diseases. We are concerned about the unintended consequence of this decision impacting both referring physicians and Medicare beneficiary access to this diagnostic technology.”
The Medical Imaging & Technology Alliance (MITA)