As complex life-saving instruments, medical imaging devices require regular servicing to ensure they function correctly. This may include routine maintenance, moving a device, or switching out a worn-out part with an exact replacement.
However, if this servicing is done improperly, it may constitute remanufacturing. Remanufacturing is an activity in which a medical device is altered in such a way that there is significant risk that the device will no longer function as intended and thus is rightfully regulated by the Food & Drug Administration (FDA).
Remanufacturing encompasses activities that result in changes to any of the following: sterilization methods, reprocessing instructions, control mechanisms, operating principle, energy input or output, or design.
When unregulated remanufacturing occurs, it can put technicians and patients at risk for serious injury or result in poor image quality, leading to a delayed or missed diagnosis or repeated imaging procedures, and increased healthcare costs.
Fortunately, Congress is considering action to protect the health and safety of patients and healthcare providers by addressing this issue.
New legislation, The Clarifying Remanufacturing to Protect Patient Safety Act (H.R. 7253), would better protect patients by:
- Defining remanufacturing in statute and clarifying the activities that require registration, reporting, and oversight.
- Educating those who service these complex medical devices about remanufacturing activities and ensure they fall under proper FDA oversight.
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.
A New Hope: Advancements in Diagnostic Imaging and Alzheimer’s
Innovative Imaging: Radiopharmaceuticals Save Lives
Patient Spotlight: Betsy De Parry
Advocate Spotlight: Geri & Jim Taylor
MITA PET Imaging Resources
Focused Ultrasound Technology Coverage
By guiding care pathways and allowing clinicians to screen, evaluate, stage, manage, and effectively treat patients with cancer, heart disease, neurological degeneration, and numerous other medical conditions, medical imaging technologies and image-guided therapies are a vital pillar of the nation’s healthcare infrastructure. One particularly promising technology is focused ultrasound (FUS). An early-stage, non-invasive therapeutic technology, FUS has the potential to transform the treatment of many medical disorders by using ultrasound energy to target tissue deep in the body without incisions or radiation.
But policymakers can and should do more to advance patient access to innovative therapeutic technologies like FUS. The current state of development and innovation within the healthcare sector, all with the goal of supporting public health via improved patient access, calls for public policy to change apace, especially to new technologies approved by the Food and Drug Administration (FDA).
Unfortunately, there is often a multiple-year delay between FDA clearance or approval of a new technology and coverage by the Centers for Medicare & Medicaid Services (CMS). This inefficient lag postpones timely access to new medical products and services. Progress has been made to accelerate regulatory approval of modern and innovative technologies through programs like the Breakthrough Devices and Safer Technologies Programs and the Medicare Coverage of Innovative Technology (MCIT) rule. But more can be done to facilitate structural collaboration among CMS, FDA, industry, and others to accelerate clearance/approval, and coverage. This would lead to quicker adoption of medically indicated products and services.
We encourage the adoption and the expansion of approval and coverage pathways that allow more patients more access to innovative technologies, like focused ultrasound.