Enhancing Medical Imaging Through AI
Artificial intelligence (AI) seems to be everywhere these days, and medical imaging is no exception.
AI has been used for decades in medical imaging, helping physicians swiftly analyze data, detect abnormalities, and make informed diagnoses. AI and machine learning (ML) medical imaging devices must be authorized as safe and effective by the Food and Drug Administration (FDA) before they can be used by clinicians. AI/ML medical imaging devices aid healthcare providers in multiple ways, including:
- Helping to identify potential tumors on mammograms and other scans more accurately and quickly;
- Personalizing treatment plans by identifying an optimal radiation dose and based on a tumor's size and location;
- Automatically detecting potential aneurysms within brain scans; or
- Helping detect abnormalities on imaging that may signal emergent conditions like stroke, pulmonary embolism, or traumatic injuries.
While AI medical devices are proliferating and advancing in their capabilities, without reimbursement, patients will lack access. That’s where Congress can help.
It’s critical that Congress recognize the value that AI in medical imaging brings to patients. To support innovation, adoption, and access to these innovations, we need Congress to work with the Centers for Medicare & Medicaid Services (CMS) to appropriately reimburse doctors who use FDA-authorized AI medical imaging tools.
Radiopharmaceutical Diagnostic Access
Positron Emission Tomography (PET) is a type of molecular medical imaging that uses very small amounts of radioactive materials, called radiopharmaceuticals, to provide detailed pictures of what is happening inside the body at the cellular level. PET imaging aids in the diagnosis and treatment of disease, particularly for various types of cancers, cardiovascular disease and neurological disorders such as Alzheimer’s and Parkinson’s disease.
By offering more precision in the assessment, these procedures support earlier diagnosis and improved treatment decision making in a growing number of disease states.
Despite the enormous value of these procedures in the diagnosis of dangerous diseases, not all Medicare Beneficiaries have access to these advanced diagnostic tools. This is because under the current Medicare payment methodology, many hospitals are unable to cover the cost of newer, targeted diagnostic radiopharmaceuticals due to insufficient reimbursement.
Without equitable reimbursement of radiopharmaceutical diagnostics, many providers instead use comparatively inexpensive but less effective tests, which can undermine patient treatment outcomes. Given the staggering health and economic burden of degenerative neurological diseases such as Parkinson’s and Alzheimer’s, and cancers, including breast, prostate, and neuroendocrine tumors, it’s critical for Congress to move decisively to enact legislation that resolves this payment inequity by affording payment of diagnostic radiopharmaceuticals.
America’s Medicare population deserves access to care that improves health outcomes and reduces downstream medical costs.
Congressional Briefings:
A New Hope: Advancements in Diagnostic Imaging and Alzheimer’s
Innovative Imaging: Radiopharmaceuticals Save Lives
Blog Posts:
Patient Spotlight: Betsy De Parry
Advocate Spotlight: Geri & Jim Taylor
Ensure Patient Safety Through Accountable Medical Device Servicing
Medical imaging devices are highly complex pieces of capital equipment, so even small repairs require extensive expertise and oversight.
Patients and providers depend on the safe and effective operation of these devices, but if imaging systems are improperly serviced, patients and providers could be injured, downtime could result in delayed care, or poor images could be produced, leading to delayed or missed diagnosis or repeated imaging procedures, which increase healthcare costs. Patients deserve to know that medical device servicers don’t cut corners and take responsibility for quality and safety.
Unlike original equipment manufacturers (OEMs), non-manufacturer independent servicing organizations (ISOs) are unregulated by the FDA and largely escape any oversight or accountability. Little is known about how many ISOs are operating or what experience or qualifications ISO servicers typically have. Even the FDA has noted that the precise number of entities that perform servicing of medical devices in the U.S. is not known.
Any service business working on a sophisticated and expensive piece of medical device technology should be well-trained and properly qualified. And they should be required to demonstrate these qualifications in line with FDA requirements.
The FDA should hold all servicers to the same quality, safety and regulatory requirements, including:
- Registration: All servicers of medical devices should be required to register with the FDA.
- Quality Management System: All servicers of medical devices should be required to adopt and maintain a quality management system that ensures devices are returned to safe and effective condition.
- Reporting of Adverse Events: All servicers should be required to report adverse events to the FDA when they encounter death, serious injury, or device malfunction.