Nuclear Medicine in 2026: How Market Access Determines Lifecycle Success

The US offers the most concrete view of how reimbursement design determines treatment capacity. Coding, status indicators, and packaging thresholds are not abstract policy artifacts—they directly translate into whether a center can run a profitable PSMA PET program or accept Lu-177 referrals. This section anchors the strategic discussion that follows of the actual mechanics that govern US payment, with figures drawn from the Center for Medicare and Medicaid Services (CMS) Addendum B for CY2026 (April 2026 update).

Reimbursement Structure and Site-of-Care Economics

Reimbursement in the US varies significantly by site of care, directly impacting margins and adoption. Under Medicare, HOPDs are paid through the OPPS, where the imaging procedure is paid via an Ambulatory Payment Classification (APC) and the radiopharmaceutical may be paid separately or packaged into the procedure payment depending on its OPPS status indicator and applicable policies, e.g., Transitional Pass-Through (TPT) status or the CY2026 diagnostic radiopharmaceutical packaging threshold of $655 per day. Variability across settings—hospital outpatient departments (HOPDs), freestanding imaging centers—and payer policies drives meaningful differences in site-level economics and adoption patterns.

At HOPDs, the PET imaging procedure is paid via APC (e.g., CPT 78815, “PET image w/CT skull-thigh,” APC 5594, paid at $1,460.92 in CY2026), while the radiopharmaceutical payment depends on its Status Indicator (SI):

• SI “K”: separate payment (these products may fall under TPT or qualify for separate payment under the CY2026 $655/day threshold).
• SI “N”: packaged into the procedure payment (no TPT, below the CY2026 $655/day threshold)—illustrating how reimbursement classification can determine whether centers can scale imaging volumes sustainably.

At freestanding imaging centers, imaging is reimbursed under the Physician Fee Schedule (PFS); OPPS status indicators do not apply. Payment depends on PFS rules and payer contracts, and centers typically require either (i) sufficient technical reimbursement to cover radiopharmaceutical costs, or (ii) explicit line-item payment for the radiopharmaceutical to support sustainable use of expensive PET agents.

Key Policy Mechanisms and Reimbursement Thresholds

Two CMS mechanisms determine how a radiopharmaceutical is paid after launch, and particularly for diagnostics if it is paid separately or packaged in the procedure— and both should be embedded in the lifecycle strategy from the outset:

1. TPT applies to both therapeutics and diagnostics, and enables temporary separate payment at launch (for no more than three years), supporting strong initial uptake since it enables a payment that covers both drug acquisition and pharmacy overhead. TPT expiration can create a “reimbursement cliff” that differs by product:
   • Therapeutic radiopharmaceuticals: the product remains separately payable, under SI “K” after TPT expiration, but the payment rate is set under standard OPPS rate-setting for that HCPCS code (e.g., ASP-based, claims-derived approaches, depending on CMS policy and data availability). This transition can create a reimbursement cliff since post-TPT the hospital bears the pharmacy overhead (high for radiopharmaceuticals) which can lead to negotiate harder on therapy acquisition price. A recent example is Pluvicto’s TPT period which ended September 30, 2025; the product transitioned to SI “K” and paid at $259.596/mCi in CY2026—approximately $51,919 for a 200 mCi treatment cycle.
   • Diagnostic radiopharmaceuticals: TPT expiration triggers the packaging threshold payment described below: the product moves either to separate payment (SI “K”) or to packaging (SI “N”) depending on its per-day cost.
2. The CY2026 $655/day diagnostic radiopharmaceutical packaging threshold. CMS introduced the structural rule under which diagnostic radiopharmaceuticals exceeding $655 per day qualify for separate payment, while those below the threshold are packaged into the procedure payment. The threshold was set at $630 in CY2025 and increased to $655 in CY2026. This is the binary diagnostic reimbursement cliff. Higher-cost PSMA-PET tracers (F-18 piflufolastat, Ga-68 gozetotide) sit well above the threshold and are paid separately. Routine, low-cost diagnostics such as F-18 FDG sit below the threshold and are packaged. The risk zone is the band of next-generation diagnostics whose per-day cost lands close to the boundary—where year-on-year payment rate fluctuations or threshold updates can flip the SI classification.

The strategic implications for products operating near the threshold are significant: a binary reimbursement cliff, pricing strategies that must be anchored around CMS threshold behavior, margin risk for products straddling the boundary, and constrained innovation when delivered cost exceeds reimbursable economics.

Theranostic Pathway Misalignment

Bundling dynamics will increasingly constrain theranostic models unless diagnostic and therapeutic pathways remain aligned in payment design. In US theranostic pathways, diagnostics and therapeutics are reimbursed separately, authorization delays occur between imaging and therapy, and incentives across imaging and therapy departments are often misaligned. Reimbursement design—not clinical demand—determines how many patients are ultimately treated.