CMS' Amyloid PET imaging coverage denial
September 16, 2013
By Gary Dillehay, Peter Herscovitch, and Satoshi Minoshima
In June, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule regarding coverage for the use of beta-amyloid positron emission tomography (PET) imaging agents. CMS agreed to cover one PET scan to exclude Alzheimer’s disease under a coverage with evidence development (CED) program — which grants conditional reimbursement upon collection of specific data — but only for patients participating in specific clinical studies.
The specific clinical trials that fall under the CMS requirements are long-term studies designed to develop better treatments or prevention strategies for Alzheimer’s disease, to identify subpopulations at risk, or to resolve clinically difficult differential diagnoses. It is proposed that patients enrolled in these studies continue until death, at which time autopsy is possibly performed. Given the length of these clinical trials and a significant burden on participating patients, it will take many years for researchers to collect data on the effect of brain amyloid imaging on health outcomes. Should this proposed rule be finalized, it will be a substantial amount of time before CMS would likely provide coverage for brain amyloid imaging.
The Society of Nuclear Medicine and Molecular Imaging (SNMMI) believes that sufficient benefits and evidence exist to support immediate coverage, which would change patient management, leading to better health outcomes for patients and assisting families making care decisions. The current standard of care for Alzheimer’s disease and related dementing disorders is not necessary to attempt fundamental treatments or prevention alone. It is a quality of care and care arrangement based on best diagnosis available to patients. SNMMI believes that the proposed CED is not appropriate for the test and patient population, which the U.S. Food and Drug Administration has already approved, noting its clinical utility.
Earlier this year the Alzheimer’s Association and SNMMI jointly developed appropriate use criteria (AUC) to demonstrate that adequate evidence exists for Medicare to cover brain amyloid imaging without additional onerous steps. The criteria stated that for amyloid imaging to be considered appropriate, individuals must exhibit several characteristics. These include: (1) a cognitive complaint with objectively confirmed impairment; (2) Alzheimer’s disease as a possible diagnosis, but when the diagnosis is uncertain after a comprehensive evaluation by a dementia expert; and (3) knowledge of the presence or absence of amyloid-beta pathology is expected to increase diagnostic certainty and alter management.
Should all of these criteria be met, amyloid PET imaging is appropriate in the following scenarios:
An additional seven scenarios were determined as inappropriate for amyloid PET imaging. These include patients with core clinical criteria for probable Alzheimer’s disease with typical age of onset; to determine dementia severity; solely based on a positive family history of dementia or presence of APOE4 which is a risk factor for AD; patients with a cognitive complaint that is unconfirmed on clinical examination; in lieu of genotyping for suspected autosomal mutation carriers; in asymptomatic individuals; and for non-medical usage (e.g. legal, insurance coverage, or employment screening). SNMMI is developing technical procedure guidelines for ensuring quality in the performance of the procedures. Additionally, SNMMI will soon be releasing a comprehensive education program for physicians who will be referring patients and those who will be reading the scans.
SNMMI will be joining with other groups, including the Alzheimer’s Association, to advocate for a change in this proposed rule before the final one is released later this fall. By sharing information and perspectives from the scientific and patient communities, it is our hope that we will be able to better help patients suffering from dementia now, and CMS will change their ruling.
About the authors: Gary Dillehay, MD, FACR, FACNM, is president of SNMMI and professor of radiology at the Northwestern University Feinberg School of Medicine. Peter Herscovitch, MD, is president elect of SNMMI. Satoshi Minoshima, MD, PhD, is chair of SNMMI Scientific Program Committee and Wil B. Nelp Professor and Vice Chair for Research in the Department of Radiology at the University of Washington in Seattle.
In June, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule regarding coverage for the use of beta-amyloid positron emission tomography (PET) imaging agents. CMS agreed to cover one PET scan to exclude Alzheimer’s disease under a coverage with evidence development (CED) program — which grants conditional reimbursement upon collection of specific data — but only for patients participating in specific clinical studies.
The specific clinical trials that fall under the CMS requirements are long-term studies designed to develop better treatments or prevention strategies for Alzheimer’s disease, to identify subpopulations at risk, or to resolve clinically difficult differential diagnoses. It is proposed that patients enrolled in these studies continue until death, at which time autopsy is possibly performed. Given the length of these clinical trials and a significant burden on participating patients, it will take many years for researchers to collect data on the effect of brain amyloid imaging on health outcomes. Should this proposed rule be finalized, it will be a substantial amount of time before CMS would likely provide coverage for brain amyloid imaging.
The Society of Nuclear Medicine and Molecular Imaging (SNMMI) believes that sufficient benefits and evidence exist to support immediate coverage, which would change patient management, leading to better health outcomes for patients and assisting families making care decisions. The current standard of care for Alzheimer’s disease and related dementing disorders is not necessary to attempt fundamental treatments or prevention alone. It is a quality of care and care arrangement based on best diagnosis available to patients. SNMMI believes that the proposed CED is not appropriate for the test and patient population, which the U.S. Food and Drug Administration has already approved, noting its clinical utility.
Earlier this year the Alzheimer’s Association and SNMMI jointly developed appropriate use criteria (AUC) to demonstrate that adequate evidence exists for Medicare to cover brain amyloid imaging without additional onerous steps. The criteria stated that for amyloid imaging to be considered appropriate, individuals must exhibit several characteristics. These include: (1) a cognitive complaint with objectively confirmed impairment; (2) Alzheimer’s disease as a possible diagnosis, but when the diagnosis is uncertain after a comprehensive evaluation by a dementia expert; and (3) knowledge of the presence or absence of amyloid-beta pathology is expected to increase diagnostic certainty and alter management.
Should all of these criteria be met, amyloid PET imaging is appropriate in the following scenarios:
- Patients with persistent or progressive unexplained mild cognitive impairment.
- Patients satisfying core clinical criteria for possible Alzheimer’s disease because of unclear clinical presentation, either atypical clinical course or etiologically mixed presentation.
- Patients with progressive dementia and atypically early age of onset (usually defined as 65 years or less in age).
An additional seven scenarios were determined as inappropriate for amyloid PET imaging. These include patients with core clinical criteria for probable Alzheimer’s disease with typical age of onset; to determine dementia severity; solely based on a positive family history of dementia or presence of APOE4 which is a risk factor for AD; patients with a cognitive complaint that is unconfirmed on clinical examination; in lieu of genotyping for suspected autosomal mutation carriers; in asymptomatic individuals; and for non-medical usage (e.g. legal, insurance coverage, or employment screening). SNMMI is developing technical procedure guidelines for ensuring quality in the performance of the procedures. Additionally, SNMMI will soon be releasing a comprehensive education program for physicians who will be referring patients and those who will be reading the scans.
SNMMI will be joining with other groups, including the Alzheimer’s Association, to advocate for a change in this proposed rule before the final one is released later this fall. By sharing information and perspectives from the scientific and patient communities, it is our hope that we will be able to better help patients suffering from dementia now, and CMS will change their ruling.
About the authors: Gary Dillehay, MD, FACR, FACNM, is president of SNMMI and professor of radiology at the Northwestern University Feinberg School of Medicine. Peter Herscovitch, MD, is president elect of SNMMI. Satoshi Minoshima, MD, PhD, is chair of SNMMI Scientific Program Committee and Wil B. Nelp Professor and Vice Chair for Research in the Department of Radiology at the University of Washington in Seattle.