Policies Impacting Patients

Third-Party Servicing

The medical imaging equipment we rely on to diagnose and monitor cancer and other life-threatening illnesses must be periodically serviced and maintained to ensure that it is working properly.The individuals servicing these devices should be highly trained and regulated to ensure patients are receiving safe and accurate scans.

Servicing technicians who work for original equipment manufacturers (OEMs) receive extensive and rigorous training, shadow more experienced technicians, and return for continuing education on new or updated devices – all under the close oversight of the Food & Drug Administration (FDA).

Unfortunately, many medical devices are maintained by unregulated third-party servicing businesses that are not required to undergo the same rigorous training program as OEM-employed servicing technicians and do not have to register with the Food and Drug Administration (FDA). As result, their work is done with little to no Federal oversight.

The FDA should hold all servicing businesses to the same quality, safety, and regulatory requirements, including proper training, implementation of quality and safety controls, adverse event reporting, and registration, to ensure that patients are receiving safe and accurate scans.

Resources:

Take Action: Urge the FDA to Ensure Safe Device Servicing to Protect Patients

The FDA should hold all servicers to the same quality, safety, and regulatory requirements; including proper training, adverse event reporting, and registration to ensure that patients are receiving safe and accurate scans.

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

Website:
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.