The landscape of nuclear medicine and molecular imaging is undergoing significant transformation due to recent changes in reimbursement policies by the Centers for Medicare & Medicaid Services (CMS). These changes specifically target how advanced diagnostic radiopharmaceuticals or radiotracers are paid for, aiming to address long-standing issues with the payments for higher cost radiotracers.
Background
Before January 1, 2025, most diagnostic radiopharmaceuticals were “bundled” into the overall payment for nuclear medicine procedures, thus high-cost radiotracers weren’t separately reimbursed. Therefore, for the newly approved radiotracers after the initial “pass-through” period, they were financially unsustainable for healthcare providers to offer. The bundling of payment created a barrier to access for patients who could benefit from these advanced diagnostics. It also restricted the development of new radiotracers crucial for theranostic applications.
Changes
Effective January 1, 2025, CMS “unbundled” the payment package for outpatient procedures and now separately pays for diagnostic radiopharmaceuticals with a per-day cost exceeding $630. Healthcare providers now receive separate payments for high-cost radiotracers. CMS acknowledges that other thresholds are possible and will adjust the threshold annually, starting in 2026.
Impact of Change
This change is expected to have a multi-faceted positive impact:
- Increased Patient Access: By separately reimbursing for higher-cost diagnostic radiotracers, CMS reduces financial barriers for healthcare providers that would otherwise limit access to these potentially life-changing scans. Patients are therefore to benefit from the appropriate diagnosis.
- Stimulated Innovation: The new policy creates a predictable market for reimbursement of advanced radiopharmaceuticals, encouraging investment in research, development, and production of new diagnostic and therapeutic agents.
- Improved treatment decisions: Better access to diagnostic radiopharmaceuticals leads to more accurate and timely diagnoses, enabling more informed treatment decisions. This is particularly important for identifying suitable candidates for targeted radioligand therapy.
- Market Growth: The policy will increase the overall market for the diagnostic radiotracers as well as radiotherapeutics.
Current Medications Affected
The change specifically impacts a range of targeted PET radiotracers. The list of included radiotracers may evolve as the threshold is adjusted annually.
Conclusion
The CMS reimbursement changes for diagnostic radiopharmaceuticals represent a significant step forward for nuclear medicine and theranostics. By addressing the financial barriers associated with these advanced agents, CMS is improving patient access to potentially life-saving diagnostic scans and paving the way for increased innovation and expanded applications of theranostics. The overall impact of this change is expected to be positive and is welcomed by nuclear medicine companies.
