Formally established under CMS rule CMS-1834-FC (the CY 2026 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center final rule), the mechanism has been active since January 1, 2026. The Centers for Medicare and Medicaid Services codified the definition of domestically produced molybdenum-99, established the billing code, and set the qualifying domestic content share, having charged the Department of Energy and the National Nuclear Security Administration with setting the underlying criteria. Providers carry the documentation and supplier verification burden, so procurement teams, not policy teams, own day-to-day compliance.
Reimbursement Mechanics Have Become Product Strategy
The broader reimbursement architecture is just as critical. CMS pays separately for diagnostic radiopharmaceuticals whose per-day cost exceeds an annually adjusted packaging threshold and packages everything below it. A product’s position relative to that line determines whether a treatment site recovers its cost or absorbs it. CMS raised the threshold for 2026, declined requests to freeze it, and acknowledged that pricing could cluster around the new line, saying it would monitor for unintended effects. It also reaffirmed its decision to keep separately payable diagnostic radiopharmaceuticals on mean unit cost based on hospital claims rather than moving to average sales price. The Society of Nuclear Medicine and Molecular Imaging has opposed this approach, arguing that mean unit cost relies on cost-to-charge ratios and outdated cost-report data. Average sales price is product-specific and updated quarterly.
The next revision is already in motion. CMS released the Calendar Year 2027 proposed rule, CMS-1850-P, on July 2, 2026, with comments due by August 31, 2026. It proposes a further increase to the packaging threshold and, more consequentially, would pay new diagnostic radiopharmaceuticals that exceed the threshold and lack claims data at average sales price plus a margin until a mean unit cost exists. This is a proposal, not a final rule, so any launch model treating the 2027 position as settled is premature.
Trade Policy and Licensing Reform Are Now Access Levers
A Section 232 proclamation issued on April 2, 2026, introduced steep duties on imports of patented pharmaceuticals and their ingredients, while conditionally exempting nuclear medicines, orphan drugs, and several other specialty categories. The duties took effect on July 31, 2026, for the large manufacturers listed in Annex III of the proclamation and will apply to other importers from September 29, 2026. The exemption is therefore being tested in practice, making eligibility a commercial consideration for programs dependent on imported isotopes, precursors, or finished products.
Licensing reform runs alongside. Executive Order 14300, signed on May 23, 2025, directed the US Nuclear Regulatory Commission to revise its regulations wholesale, with proposed rules due by February 23, 2026, and final rules by November 23, 2026. Two proposals bear directly on this sector. Modernizing NRC Regulations for Byproduct Material Use, published in the Federal Register on May 18, 2026, would amend eight parts of Title 10 of the Code of Federal Regulations, including relief from decommissioning financial assurance for short-lived therapeutic isotopes. Reducing Barriers to Medical Use Licensing, addressing training and experience requirements under 10 CFR Part 35, was published on July 27, 2026, and the Advisory Committee on the Medical Uses of Isotopes is scheduled to consider subcommittee recommendations in September 2026. Both measures remain at the proposal stage, with neither yet finalized, and the NRC’s published schedule indicates that the byproduct material rule may not be finalized until 2027.
Payment mechanics, tariff eligibility, and licensing burden now determine which programs reach patients as decisively as clinical data. Radiopharmaceuticals USA 2027 gives market access, regulatory affairs, and health economics teams a single forum for all three, covering CMS payment reform and the 2027 rulemaking cycle, Section 232 exemption strategy, NRC licensing modernization, and the coverage and coding decisions that determine viability at the treatment site.
