Radiopharmaceutical Unbundling Included in CMS FY25 HOPPS Proposed Rule

Today, CMS released its FY25 proposed rule on the Hospital Outpatient Prospective Payment System (OPPS), and it included adjustments to an existing packaging policy for diagnostic radiopharmaceuticals established in 2008. 

CMS stated, “We propose to pay separately for diagnostic radiopharmaceuticals with per day costs above a threshold of $630, which is approximately two times the volume weighted average cost amount currently associated with diagnostic radiopharmaceuticals. We also propose to update the $630 threshold in CY 2026 and subsequent years by the Producer Price Index (PPI) for Pharmaceutical Preparations.”

SNMMI enthusiastically supports this change to the current OPPS bundling system. CMS’ reimbursement of higher-priced diagnostic radiopharmaceuticals with per-day costs above a $630 threshold will allow patients access to new, more advanced diagnostic nuclear medicine procedures. The change will also align CMS’ radiopharmaceutical reimbursement policy with those for many other drugs included in the OPPS.

This would replace a system wherein diagnostic radiopharmaceuticals are treated as “supplies” and reimbursed through a packaged payment system. The methodology averages the higher cost of these specialized products with more general and widely used lower-cost radiopharmaceuticals, thus overpaying for the low-cost products and underpaying for the higher-cost products.  This results in healthcare institutions not being able to provide these services. creating a significant barrier to patient access to the newer, more precise generation of diagnostic nuclear imaging drugs.

The proposed rule is published annually and will have a 60-day comment period, which will end on September 9, 2024. The final rule will be issued in early November and will take effect January 1, 2025.

SNMMI continues to analyze the entire proposed rule and will develop a more comprehensive summary in the coming days. The Society plans to send comments to CMS for consideration in the FY25 Final Rule.

We are excited to celebrate this win for patients and the greater nuclear medicine community!