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 Coverage

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