FDA Seeks ‘Remanufacturing’ Feedback from Biomeds

A little more than a month ago, the FDA released the draft guidance “Remanufacturing of Medical Devices” and asked healthcare technology management professionals, original equipment manufacturers, third-party repair organizations and more to submit comments.

United Imaging Goes “All-in” for Nashville

United Imaging makes its debut at HealthTrust University and its in-person debut at AHRA in Nashville over the next two weeks. At both events, the company will focus on several unique aspects of how it solves pervasive pain points in procuring and owning medical imaging equipment.

TechNation Asks Biomeds to Share Right to Repair Issues

TechNation is proud to support and be an advocate for the Right to Repair movement in the healthcare technology management and health care community. A new web form specifically allows biomeds everywhere to report incidents when an original equipment manufacturer...

Delivering precision solutions for a changing world

Change has been the one constant in nuclear medicine from the beginning, with the steady arrival of new radiopharmaceuticals, new technologies and an evolving regulatory environment. Today, as nuclear medicine expands rapidly beyond diagnostics and into novel...

MITA Reacts to FDA Approval of Aducanumab for Alzheimer’s

The Medical Imaging & Technology Alliance (MITA)

The Medical Imaging & Technology Alliance (MITA) commended the U.S. Food and Drug Administration (FDA) following its decision to grant approval of aducanumab, a move that will give patients access to the first-ever disease-modifying treatment for Alzheimer’s. In light of today’s decision, MITA also called attention to additional barriers in diagnosing and treating this devastating disease.

“The action taken today by the FDA will give patients and caregivers access to the first-ever Alzheimer’s disease-modifying treatment,” said Patrick Hope, executive director of MITA. “Now, the Centers for Medicare & Medicaid Services (CMS) needs to act to update its outdated coverage and payment policies and provide patients with access to amyloid PET diagnostic drugs.”

According to the Alzheimer’s Association, more than 6 million Americans are estimated to be living with Alzheimer’s, about half of whom have not yet been diagnosed. But patients cannot get treated without confirming their diagnosis. Though the FDA approved amyloid PET scans in 2012 to allow physicians access to reliable and accurate diagnostic information to inform the care of patients living with Alzheimer’s disease, Medicare does not appropriately cover amyloid PET imaging – which is the most accurate and least invasive way to detect amyloid, a hallmark of Alzheimer’s disease.

CMS only provided access to amyloid imaging from 2016-2019 via the lengthy CMS Coverage with Evidence (CED) process. The resulting IDEAS study was the largest Alzheimer’s disease study ever conducted and resulted in a change in a patient’s disease management over 60 percent of the time. In 36 percent of cases, there was a change in diagnosis. Despite these findings, amyloid imaging agents are still not covered unless under an approved CED study.

Patients also face a second barrier to diagnosis due to Medicare’s packaged payment policy for precision radiopharmaceuticals, including amyloid PET, which results in significant losses to hospitals with each diagnostic test performed. According to a recent GAO Report, the organizers of the New IDEAS Study highlighted the challenges they are facing recruiting hospitals given the financial barriers.

It is important to note that both the current coverage and payment policies for amyloid tracers will pose significant barriers to patient access to this important diagnostic tool. CMS should act immediately to ensure patients have access to amyloid diagnostic testing that assists clinicians in diagnosing Alzheimer’s disease. Knowing this information, patients will receive a more accurate diagnosis, leading to better treatment pathways and outcomes. Importantly, future clinical trials will be assured the most appropriate patients will be included.

“CMS should revise the legacy coverage and payment policies that will hinder access to this life-changing treatment,” noted Hope. “Specifically, MITA calls on CMS to expeditiously open the amyloid PET reconsideration request that has been pending before the agency since September 2020 to ensure appropriate Medicare access.”



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