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CMS policy shouldn’t penalize those with rare disease

In 2007, I had just finished celebrating my 46th birthday when I received a diagnosis that would irrevocably shape my life for years to come. Doctors had identified a mass in my pancreas and diagnosed it as a neuroendocrine tumor. The cancer had metastasized throughout my liver and the doctors determined it was inoperable. Rather than “watch and wait,” I changed my paradigm to “watch and learn” and dove deep into research to learn about my disease. That’s how I learned about the Gallium 68 DOTA imaging– a type of positron-emission tomography (PET) diagnostic procedure. The technology was being pioneered in Europe and would, when combined with new therapeutic options, ultimately extend the length and quality of my life.

Over the last decade, I have worked tirelessly with physicians, researchers, medical societies, regulators and the industry to help bring this technology and other advanced radiopharmaceuticals to the United States and around the world. PET diagnostics have changed the way that neuroendocrine tumors are diagnosed and treated and will, I believe, improve the lives of countless patients now and for the foreseeable future.

Unfortunately, the Centers for Medicare & Medicaid Services (CMS) currently bundles innovative diagnostic tools and their procedural cost into one specific payment package after a short period of paying for them separately. The result is after a three-year period providers need to make choices about using more advanced precision diagnostic imaging and take a financial loss or stop offering the advanced imaging diagnostic and use less effective alternatives. This, in turn, impacts the diagnosis and care of those that could be imaged with advanced imaging tracers, requiring them to travel farther or perhaps skip imaging procedures that are vital for monitoring and maintaining their health.

Although I was lucky to have the means to travel to Europe and pay for my imaging exams, this isn’t the case for most Americans. At the end of this year, when the PET imaging agent separate payment period end, patients who need the diagnostic test used in neuroendocrine cancer may be at risk for not getting access to the right test. Hospitals using this groundbreaking imaging approach will be paid a “packaged” rate for the test procedure that fails to cover the cost of the radiopharmaceutical. Providers must then take a financial hit since they are unable to receive appropriate reimbursement, which requires them to decide between the patients and physicians who have come to depend on these tests and the bottom line. This applies not only to Neuroendocrine tumors but several other imaging agents whose separate imaging payment ends.

When it comes at the expense of patients like me who face life-threatening diseases, we have a problem that needs to be fixed. Diagnostic tests that are less accurate can lead to less optimal treatment decisions. 

America’s patients deserve a health care system that supports and encourages access to innovative imaging techniques. That’s why Congress should pass the Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 (H.R. 3772). This bipartisan bill would direct the Department of Health and Human Services (HHS) to pay separately for all diagnostic radiopharmaceuticals that cost over $500 per use in order to incentivize more hospitals to continue to offer these innovative and more efficient tools while adding a negligible amount to what Medicare currently pays for imaging. By ensuring patients can receive the most accurate diagnosis, Congress has a unique opportunity to improve clinical outcomes, save lives, and support the next generation of precision medicine.

I’m grateful to be here today, thanks to the advances in nuclear medicine and molecular imaging. Today, I spend my time advocating for greater access, availability, affordability and awareness of advanced imaging technology to bring hope to the millions of Americans who need it. I hope Congress will join me in doing the same.

Josh Mailman is President of NorCal CarciNET Community and a Board Member of the Neuroendocrine Tumor Research Foundation. He was the Inaugural Chair of the Patient Advocacy Advisory Board for the Society of Nuclear Medicine and continues to be on their Advisory Board.