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Assessing the reimbursement challenges facing radiopharmaceuticals

Gus Iversen, Editor in Chief | June 25, 2021
Molecular Imaging
From the June 2021 issue of HealthCare Business News magazine

The GAO Report also included information from the New IDEAS Study organizers highlighting the challenges now faced with recruitment. Those challenges are due to a change in CMS policy from paying separately for the radiopharmaceuticals to packaging them into procedural bundles, resulting in significant losses to hospitals in the Medicare outpatient setting. Additionally, at the CMS Advisory Panel on Hospital Outpatient Payment meeting on August 31, 2020, the panel recommended that “CMS pay separately for all diagnostic radiopharmaceuticals.”

HCB News: In your opinion, what are some of the prerequisites for bringing meaningful change to the reimbursement landscape?
MG: Having policy makers understand the issues is extremely important for bringing meaningful change. As you may imagine, nuclear medicine and radiopharmaceuticals are not easy to explain to a lay audience. To begin, diagnostic radiopharmaceuticals are essential to scans for diagnosis of cancer, Alzheimer’s disease and Parkinson’s disease. Lack of awareness of reimbursement issues causes a ripple effect, impeding patient access to this safe, innovative technology. For example, although diagnostic radiopharmaceuticals are classified as “drugs” according to the Food and Drug Administration (FDA), CMS classifies them as “supplies” in the Hospital Outpatient Prospective Payment System (HOPPS). Hence, they are policy-packaged (bundled) and treated the same way one would treat ancillary supplies (like gauze or syringes) used for the scan.

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SNMMI and our coalition partners have been educating our regulators and legislators about how bundling newer precision diagnostic radiopharmaceuticals with their respective scans actually impedes their use for patients. This is due to the fact that the diagnostic radiopharmaceutical costs vary significantly, and the HOPPS average reimbursement amount, applied to the radiopharmaceutical drug portion of the scan, provides an average of only 10% of the actual cost of precision diagnostic radiopharmaceuticals.

HCB News: What are some of the biggest reimbursement hurdles you've been focused on over the last year?
MG: Separate payment of diagnostic radiopharmaceuticals in the HOPPS setting has been the biggest hurdle. The FIND Act’s predecessor, H.R. 3772 (the Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019), was introduced in July 2019. While this effort was gathering steam, the world was afflicted by the COVID-19 pandemic, and most non-COVID legislative efforts in 2020 went dormant. Still, we wrapped up the year with 24 cosponsors. Now that the U.S. is reopening and healing from the impact of COVID-19, we are confident that the bill will soon be introduced.

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