The Medical Imaging & Technology Alliance (MITA)—the trade association representing manufacturers of medical imaging equipment, radiopharmaceuticals, contrast media, and focused ultrasound therapeutic devices—shared initial comments on the Centers for Medicare & Medicaid Services’ (CMS’) proposed decision memorandum on Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease released on January 11. MITA plans to submit public comments on the proposed decision to advance the diagnosis, treatment, and care of patients living with Alzheimer’s disease.   

“With its proposal for only Coverage with Evidence Development (CED) in randomized clinical trials, CMS has severely restricted and delayed beneficiary access to therapeutic treatment options, impacting the entire class of therapies,” says MITA’s executive director Patrick Hope. 

“CMS proposed a CED requirement that will be limited to hospital-based outpatient clinical trial sites,” Hope adds. “These limitations would exacerbate already existing disparities based on geography, ability to travel, and/or race. This coverage decision has long-term access implications for patients, and the CED requirement alone will create real challenges for healthcare providers, patients, families, and communities of color that are disproportionately impacted.”  

MITA believes Medicare’s final decision should allow both coverage of amyloid PET and also ensure that the right patients will have access to amyloid reduction therapies.  “We are pleased that CMS recognizes the key role that amyloid PET plays to support appropriate patient identification for amyloid-targeting therapies, but further modification to the proposed NCD is needed to allow physicians to fully utilize biomarker information to optimize patient care,” Hope adds 

Diagnostic amyloid PET has been extensively studied over the last decade since FDA approval in 2012 and has demonstrated not only effectiveness as the gold standard in identifying amyloid plaque, a hallmark characteristic of Alzheimer’s disease, but also high impact on patient management. The effective utilization of amyloid PET is, furthermore, clinically and fiscally responsible because it will discourage unnecessary drug utilization, MITA officials say.   

“The NCD also spotlights a flaw in Medicare’s payment methodology for PET diagnostic drugs in the hospital outpatient setting which will limit provider involvement and patient access,” Hope says. “The value of diagnostic amyloid PET has been studied through the CMS-sponsored CED studies.  Yet, CMS’s ‘packaged payment’ reimbursement policy has resulted in a decrease in the number of hospital outpatient facilities—from 125 hospital outpatient departments involved in the first IDEAS Study to only 16 in the recent New IDEAS Study. “ 

What’s more, Hope says, “Many of the hospitals which have chosen not to participate in New IDEAS have cited the Medicare outpatient packaged payment policy for diagnostic radiopharmaceuticals as a barrier. This has negatively impacted patient access in this study that is focused on minorities.”

To sum it up, Hope says, “MITA urges CMS to provide beneficiary access to treatment of Alzheimer’s Disease by providing appropriate coverage and payment for amyloid reduction therapies.  To ensure the appropriate patients are placed on available therapies, CMS must also appropriately cover and pay for FDA-approved diagnostic amyloid PET.”