Various organizations have applauded the decision by the CMS to remove National Coverage Determination (NCD) limitations to coverage for amyloid PET scans, including the limitation of Medicare or Medicaid coverage to one PET scan per a patient’s lifetime. It remains to be seen, however, how coverage decisions will be made by local Medicare Administrative Contractors (MACs).
The Society of Nuclear Medicine and Molecular Imaging (SNMMI), the Medical Imaging and Technology Alliance (MITA) and the Alzheimer’s Association have all praised the decision of the Centers for Medicare and Medicaid Services (CMS) to remove National Coverage Determination (NCD) coverage limitations for amyloid positron emission tomography (PET).
As a result of the CMS decision to remove limitations such as limiting Medicare/Medicaid coverage of amyloid PET scans to one per a patient’s lifetime, CMS noted that coverage decisions of this imaging for Medicare and Medicaid beneficiaries will now reside with local Medicare Administrative Contractors (MACs).
In a July 2023 interview, Jacob G. Dubroff, M.D. Ph.D., suggested there may be a degree of variability with coverage decisions being made by local MACs.
“It’s going to be very heterogeneous because it’s going to be by region. It’s not going to happen all at once. There may be differences if you live in California versus if you live in New York based on what those administrators decide,” noted Dr. Dubroff, the modality chief of nuclear medicine and therapy, and associate professor of radiology at the Hospital of the University of Pennsylvania.
In a statement on the CMS decision, MITA also acknowledged “concern among providers and patient stakeholders that the decision may lead to uncertainty on coverage and possible claim delays following the end (of the NCD for amyloid PET).” However, MITA also noted the CMS suggestion that “there will be consistent coverage across regions for appropriate Medicare patients.”
While Dr. Dubroff noted the viability of amyloid PET imaging as an “elegant, well-tolerated safe test” for detecting abnormal protein accumulation and monitoring the efficacy of anti-amyloid treatments, he said the expanded use of amyloid PET imaging will also be a daunting economic proposition.
“If you open the floodgates and allow all the testing and all the treatment, that is going to be a lot of money. How do we do this in a way that makes sense where we get the most benefit out of imaging and the drug?” posited Dr. Dubroff.
That said, Helen Nadel, M.D., FRCPC, FSNMMI, praised the CMS decision for increasing access to emerging anti-amyloid treatments for the management of patients with Alzheimer’s disease and other neurodegenerative conditions.
“SNMMI applauds CMS for recognizing the pivotal role of amyloid PET scans in effectively managing Alzheimer's and other dementias,” said Nadel, the president of SNMMI. "This decision ensures increased accessibility to this crucial nuclear medicine test for eligible patients and facilitates the targeted use of new treatments for those who can benefit."
Maria C. Carrillo, Ph.D., concurred, noting that the expanded access to amyloid PET imaging may facilitate earlier detection and intervention for patients with Alzheimer’s disease.
“Amyloid PET scans are a proven tool and can be an important part of Alzheimer’s diagnosis and treatment,” said Dr. Carrillo, the chief science officer of the Alzheimer’s Association, in a statement. “Broader access to amyloid PET scans will enable earlier and more accurate diagnosis, and better care management. Their use can lead to better health outcomes for people living with Alzheimer’s or another dementia. This decision reflects the FDA’s confidence in this technology after many years of evaluation.”