bottlenecksBottleneck

Reimbursement and coding for radiopharmaceuticals

In the US, insurance pays extra for a new radioactive scan for a couple of years, then that extra payment can suddenly stop, even though the drug still costs the same to make. That cliff has already made at least one scan much harder for patients to get.

US Medicare has historically packaged diagnostic radiopharmaceuticals into the payment for the imaging test itself, treating them as a 'supply' rather than reimbursing their actual cost. New diagnostic radiopharmaceuticals typically get two to three years of transitional 'pass-through' status, during which their cost is separately and fully reimbursed; once pass-through expires, additional payment can drop to zero, which the American College of Radiology cites as the reason amyloid PET imaging has had persistently limited availability.

After years of lobbying by SNMMI, ACR and others, CMS's CY2025 Hospital Outpatient Prospective Payment System (HOPPS) final rule, released 1 November 2024 and effective 1 January 2025, created a new middle tier: any diagnostic radiopharmaceutical without pass-through status, whose per-day cost exceeds a $630 threshold (set at twice the average $314 CMS assumed was already bundled into existing payments), now receives ongoing separate payment based on Mean Unit Cost (MUC) derived from hospital claims data. Twenty-six products qualified for 2025, more than half of them PET tracers; the threshold is indexed to the Producer Price Index for Pharmaceuticals from 2026 onward.

A parallel change took effect for the isotope supply chain itself: from 1 January 2026, CMS pays a $10-per-dose add-on for technetium-99m derived from domestically produced (non-highly-enriched-uranium) molybdenum-99, intended to reward and de-risk the US reshoring effort described under the Mo-99 supply bottleneck. Therapeutic radiopharmaceuticals remain reimbursed at ASP+6% where average sales price data exists, but manufacturers are not mandated to report ASP, so many still fall back to the same claims-based MUC methodology CMS uses for diagnostics.

moderatefunding incentives0 ideas to fix it

Scale of the problem

$630 per day (2x the $314 CMS assumed was already packaged)

CY2025 HOPPS separate-payment threshold for diagnostic radiopharmaceuticals

source

26 products, >half PET tracers

Diagnostic radiopharmaceuticals qualifying for separate payment in 2025

source

$10 per dose

New Mo-99 domestic-sourcing add-on payment, effective 1 January 2026

source

2–3 years

Typical pass-through period before reimbursement can drop to zero

source

Root causes

Diagnostic radiopharmaceuticals were historically bundled into HOPPS payment for the imaging test as a 'supply', which undervalued high-cost tracers relative to their actual acquisition cost.
Transitional pass-through payment periods expire after 2–3 years, creating a reimbursement cliff exactly when a product is scaling into routine use.
Manufacturers are not required to report average sales price (ASP) data, so CMS has had to rely on claims-derived Mean Unit Cost as a proxy, which lags real-world pricing.
Reimbursement policy has historically been set per-product rather than for the radiopharmaceutical drug class as a whole, so each new tracer or therapy faces the same fight from scratch.

Current efforts

SNMMI and ACR multi-year advocacy that led directly to the CY2025 HOPPS separate-payment policy for diagnostic radiopharmaceuticals.
CMS commitment to index the $630 threshold annually to the Producer Price Index for Pharmaceuticals from 2026, rather than leaving it fixed.
CMS's new domestic Mo-99 sourcing add-on payment, aligning reimbursement incentives with the isotope-supply-chain resilience goals described elsewhere in this graph.

Success criteria

Radiopharmaceutical reimbursement that follows the product's real cost continuously from launch through the life of the pass-through period and beyond, so no approved, clinically useful tracer or therapy loses access because of a coding cliff.