In 2025, CMS will begin unbundling and separately reimbursing high-cost diagnostic radiopharmaceuticals.
Cindy Yuan, MD, PhD, ACR Commission on Economics Nuclear Medicine Committee contributed as guest columnist for this piece.
Since 2008, payment for diagnostic radiopharmaceuticals in the hospital outpatient setting has been packaged or bundled into the payment for the underlying imaging exam. Though this practice was tolerable for relatively simple, straightforward exams (i.e., those that typically utilize only one type of radiopharmaceutical such as a whole-body bone scan), this practice is no longer practical for many reasons.
Almost all PET exams are reported and reimbursed for with generic CPT® codes that are only differentiated by their field of view (e.g., 78816: PET with concurrently acquired CT for attenuation correction and anatomical localization imaging; whole body). Similarly, many nuclear medicine exams do not have a dedicated CPT code, such as dopamine transporter single-photon emission CT (SPECT) imaging. When exams are reported using relatively generic CPT codes for imaging, based solely on field of view and technology type, they are reimbursed at a uniform level regardless of tracer type.
However, imaging providers pay vastly different prices for different types of tracers (e.g., fluorodeoxyglucose versus DOTA-TATE) despite receiving the same reimbursement for the overall exam. This can make some imaging agents — and related services — simply too expensive for practices to offer because the reimbursement for the entire exam does not even cover the cost of the tracer.
Novel diagnostic radiopharmaceuticals typically have a two- to three-year pass-through period, during which time a radiopharmaceutical’s cost is fully reimbursed by CMS, in addition to the reimbursement for the imaging exam. However, after that pass-through period, the additional radiopharmaceutical reimbursement drops to zero, which often translates to significantly decreased access for patients and referring providers. This has recently been seen with amyloid PET imaging, which has relatively limited availability due to these adverse financial dynamics.
When exams are reported using relatively generic CPT codes for imaging, based solely on field of view and technology type, they are reimbursed at a uniform level regardless of tracer type.
After many years of educational and lobbying efforts by many national societies, CMS is recognizing these flaws and, in 2025, will unbundle and separately pay for high-cost diagnostic radiopharmaceuticals as part of the 2025 Hospital Outpatient Prospective Payment System (HOPPS) Rule. Initially set at $630, the “high cost” threshold is double the weighted average offset amount (i.e., cost) across all the nuclear medicine ambulatory payment classifications.
CMS acknowledged that many different thresholds are possible, but it applied a “two-times rule,” which is also utilized in other realms of threshold-setting, as the initial boundary. Starting in 2026, CMS plans to annually adjust this threshold based on the Producer Price Index (PPI) for Pharmaceuticals for Human Use (Prescription). For 2025, twenty-six diagnostic radiopharmaceuticals reached this threshold for unpackaging, and more than half are PET tracers.
For the diagnostic radiopharmaceuticals that exceed the cost threshold, the separate additional payment will be based on the mean unit cost (MUC) as derived from HOPPS claims. Typically, CMS sets payment levels based on average sales price (ASP) data, but radiopharmaceutical manufacturers are not mandated to report per patient, per day costs, so few manufacturers do. Therefore, CMS is using MUC as the next best proxy for average price. Unfortunately, MUC has many flaws, most obviously that it is a calculated/imputed cost. Fortunately, CMS has left the door open to using ASP in the future if appropriate data were reported by manufacturers.
Since this pricing and reimbursement scheme is based on national average costs, we will inevitably have some institutions where high-cost diagnostic radiopharmaceuticals remain unavailable due to local contracting conditions. However, this new reimbursement scheme should significantly enhance the ability to deliver standard-of-care imaging exams in a wider geographic and socioeconomic range. As the new rules play out, please continue to report reimbursement challenges to the ACR for the College to continue advocating for greater access to these important specialized services.
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