Lantheus Announces CMS Grants Transitional Pass-Through Status for PYLARIFY® TruVu (piflufolastat F 18)
Lantheus (NASDAQ: LNTH) announced CMS granted Transitional Pass-Through payment status for PYLARIFY® TruVu (piflufolastat F 18), effective October 1, 2026. This designation enables separate reimbursement in hospital outpatient settings, supporting access to the diagnostic radiopharmaceutical for Medicare beneficiaries. PYLARIFY TruVu is a new formulation of Lantheus’ PSMA-targeted PET imaging agent for prostate cancer, with a permanent HCPCS code assigned for billing and reimbursement.
How this was made
The 30-second read
Why it matters
The regulatory approval removes a reimbursement barrier, likely expanding sales and improving margins for the company's imaging portfolio.
Market read
First-report of CMS TPT status for a leading PSMA PET agent, a material regulatory development for LNTH.
What to watch
Potential supply constraints, payer policy changes, and the pace of geographic rollout could affect the realized benefit.
Background
Lantheus Holdings (NASDAQ: LNTH) announced CMS reimbursement status for its new PSMA PET imaging agent, PYLARIFY® TruVu.
Ticker impact
CMS granted Transitional Pass-Through payment status for Lantheus' PYLARIFY® TruVu, enabling separate reimbursement starting Oct 1, 2026.
likely upside as market prices in higher reimbursement potential
Reimbursement status directly improves revenue outlook for the company's PSMA PET product line.
Market effects
strengthens the US radiopharmaceutical and diagnostic imaging sector by setting a reimbursement precedent.
boosts US healthcare providers' adoption of advanced PSMA PET imaging.
may encourage global regulators to consider similar reimbursement pathways for PSMA agents.
Counterpoint
If CMS limits the scope of TPT usage or if competing agents gain market share, the price impact could be muted.
Key entities
- CompanyLantheus Holdings, Inc.
US-listed radiopharmaceutical developer.
- RegulatorCenters for Medicare & Medicaid Services (CMS)
U.S. federal agency granting reimbursement status.

