The Centers for Medicare & Medicaid Services (CMS) introduced its final rule for CY2025, and its updates carry far-reaching implications for patients, healthcare providers, and, of course, radiopharmaceutical developers and manufacturers.
Here’s what you need to know:
Why the change?
Previously, diagnostic radiopharmaceuticals were reimbursed under a packaged or “bundled” payment system. In this system, generic CPT codes are used for reimbursement because the payment is bundled with the imaging procedure rather than reflecting the actual cost of the radiopharmaceutical itself.
This approach often led to financial challenges, as it failed to account for the significant price differences between various diagnostic agents. Providers received the same reimbursement regardless of the specific radiopharmaceutical used, making it financially difficult to offer more advanced imaging options. As a result, patient access to cutting-edge diagnostic imaging was often limited, forcing providers to make tough choices between costs and clinical effectiveness.
CMS’s updated policy hopes to begin removing these barriers to cutting-edge diagnostics and broaden patient access through a more equitable payment model for providers.
What’s new in this policy?
- Diagnostic radiopharmaceuticals with a per-day cost exceeding $630 will now receive separate reimbursement, allowing providers to better offset the cost of advanced imaging agents.
- The $630 threshold was calculated as double the weighted average cost across nuclear medicine classifications, focusing on high-cost agents that pose the most significant access challenges. CMS plans to adjust this threshold annually starting in 2026, using the Producer Price Index (PPI) for Pharmaceuticals.
- For qualifying radiopharmaceuticals, CMS will determine payment based on mean unit cost (MUC) data derived from claims. While this method isn’t perfect—MUC is a calculated cost rather than a direct measure—it’s a step forward in addressing financial gaps. CMS has left the door open to using average sales price (ASP) data if manufacturers begin reporting it.
Looking ahead
While challenges remain, including local contracting disparities and the need for ongoing advocacy to refine reimbursement methodologies, policies like this highlight CMS’s recognition of radiopharmaceuticals’ critical role in modern medicine.
As reimbursement models become more supportive of high-cost radiopharmaceutical diagnostics, they also lay the groundwork for expanding access to therapeutic applications and removing financial barriers that have historically limited availability.
As an end-to-end CDMO, we’re thrilled to see policies that advance access to targeted radiopharmaceuticals.
How can we help bring your therapy to market? We’d love to talk.