For seventeen years, diagnostic radiotracers were invisible in Medicare payment. That changed in 2025, and the rules are still moving. Our new whitepaper breaks down what manufacturers need to do before the CY2027 comment window closes.
FCMS now pays separately for high-cost diagnostic radiopharmaceuticals, but the payment basis, the coding requirements, and the coverage landscape remain in motion, and the CY2027 proposed rule closes for comment August 31, 2026.
This white paper traces how the current framework developed, identifies who actually controls coverage decisions (hint: it’s not just CMS), and lays out a twelve-to-thirty-six-month action plan for developers of diagnostic radiopharmaceuticals.
What’s Inside:
- Why mean unit cost payment breaks down for low-volume, high-cost tracers
- The coding mismatch fueling prior authorization denials
- Why commercial payer policy, not CMS, often sets the real coverage bar
- The 340B proposal that could hit your highest-volume sites
- A 12-to-36 month action roadmap for manufacturers
Authors
SVP, Market Access & Reimbursement, Avania
Eric Lam, PhD
SVP, Advisory Services, Avania
Angela Johnson, PhD, RAC, PMP
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