CMS proposes issuing separate payment for diagnostic radiopharmaceuticals in 2025

The Centers for Medicare and Medicaid Services is proposing issuing a separate payment for diagnostic radiopharmaceuticals, a change long lobbied for by the imaging industry.

CMS announced the decision as part of the 2025 Hospital Outpatient Prospective Payment System rule released on Wednesday. For years, the agency has packaged together payment for nuclear imaging agents together with the procedure. However, this can create a barrier for those who require pricier new radiopharmaceuticals, advocates note.

Under the proposal, CMS would pay separately for diagnostic imaging agents with per-day costs above a threshold of $630. The Society of Nuclear Medicine & Molecular Imaging—which has for years fought for this change—applauded the proposal Wednesday.

“SNMMI enthusiastically supports this change to the current OPPS bundling system,” the society said in a statement. “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.”

The threshold is about two times the volume-weighted average cost currently associated with diagnostic radiopharmaceuticals. CMS also is proposing to update the $630 threshold in 2026 and subsequent years based on the Producer Price Index for Pharmaceutical Preparations, the American College of Radiology reported in its summary of the OPPS rule. The agency will pay separately for diagnostic radiopharmaceuticals based on the average unit cost derived from claims and is seeking feedback on using average sales price for future reimbursement.

Under the current system, CMS treats diagnostic radiopharmaceuticals as “supplies” packaged together with the imaging exam. This methodology averages the higher cost of these products with more general and widely used lower-cost drugs, “thus overpaying for the low-cost products and underpaying for the higher-cost products,” SNMMI noted.

The Advanced Medical Technology Association, which represents device manufacturers, called the decision an “important step forward,” particularly for patients with Alzheimer’s, Parkinson’s, heart disease and certain cancers. Achieving separate payment for nuclear imaging agents is “top priority” among its members.

“CMS’ proposal for separate payment of diagnostic radiopharmaceuticals is welcome news to millions of patients and their family members who will now have better access,” Patrick Hope, AdvaMed Medical Imaging executive director, said in a statement. “With this proposal, CMS is recognizing the value of diagnostic radiopharmaceuticals and the importance of expanding access of these diagnostic imaging agents to more patients so that they might receive better treatment and care.”  

The OPPS proposal will have a 60-day comment period ending on Sept. 9. Pending any further changes, CMS will issue a final rule in November with it taking effect on Jan. 1.

Marty Stempniak

Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic. 

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