{"entity":{"id":"f-regulation-reimbursement","kind":"section","name":"Regulation & reimbursement","aka":[],"tldr":"Getting one of these radioactive medicines approved and then actually paid for is its own specialised process, separate from ordinary drugs, and the rules for who pays what changed again for 2026 in the US.","summary":"Radiopharmaceuticals are regulated as a distinct drug category. In the US, the FDA reviews and approves them under the same statutory framework as other drugs but with radiopharmaceutical-specific guidance on chemistry, manufacturing and controls; in the EU the EMA's guideline on the quality of radiopharmaceuticals is being revised (draft revision 2, public consultation closed 30 April 2026) to update how manufacturing dossiers describe the process from radionuclide production onward and how radionuclidic/radiochemical impurities are controlled. The UK's MHRA updated its clinical-trials GMP guidance for radiopharmaceutical investigational medicinal products, effective 28 April 2026, clarifying which manufacturing and QP-certification steps can be split between licensed facilities.\n\nPayment is a separate and increasingly consequential fight, especially in the US Medicare system. Under the CY2026 Hospital Outpatient Prospective Payment System final rule, CMS raised the per-day cost threshold above which diagnostic radiopharmaceuticals are paid separately (using hospital-claims-derived mean unit cost) from $630 to $655, continuing a policy that packages lower-cost diagnostic tracers into the payment for the imaging procedure itself rather than paying for them separately — a policy nuclear medicine societies have long argued undervalues newer, higher-cost diagnostic agents. CMS also created a new $10-per-dose add-on payment, effective 1 January 2026, for technetium-99m doses derived from domestically produced molybdenum-99 (HCPCS code C9176, requiring at least 50% of the Mo-99 to have been both irradiated and processed in the US), replacing an earlier add-on that had rewarded non-highly-enriched-uranium production regardless of country of origin. Separately payable therapeutic radiopharmaceuticals without pass-through status continue to be paid at ASP+6%, falling back to WAC+3% or 95% of AWP when ASP or WAC data are unavailable.\n\nWhat remains unresolved: ASP (average sales price) reporting for diagnostic radiopharmaceuticals is still voluntary under CMS rules for 2026, which limits how accurately the mean-unit-cost proxy reflects true market prices, and CMS says it \"intends to explore\" updated ASP-reporting guidance without having committed to a firm change. Medicare's coverage-with-evidence-development pathway continues to gate access to some newer radiopharmaceuticals pending real-world outcomes data, and reimbursement policy differs enough between the US, the EU (EMA/national payers) and other regulators (Japan's PMDA, the UK's MHRA) that global access to a newly approved agent can lag its first approval by years.","asOf":"2026-09-22","links":[{"label":"CMS: Hospital Outpatient Prospective Payment System, January 2026 update (MM14361)","url":"https://www.cms.gov/files/document/mm14361-hospital-outpatient-prospective-payment-system-january-2026-update.pdf"},{"label":"Sidley: Medicare payment policy final rule for outpatient setting addresses radiopharmaceuticals (Dec 2025)","url":"https://www.sidley.com/en/insights/newsupdates/2025/12/medicare-payment-policy-final-rule-for-outpatient-setting-addresses-radiopharmaceuticals"},{"label":"EMA: draft guideline on the quality of radiopharmaceuticals, revision 2","url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-radiopharmaceuticals-revision-2_en.pdf"},{"label":"MHRA: clinical trials GMP and radiopharmaceutical IMPs guidance (updated 28 April 2026)","url":"https://www.gov.uk/guidance/clinical-trials-for-medicines-good-manufacturing-practice-and-radiopharmaceutical-investigational-medicinal-products"}],"tags":[],"related":["f-radiochemistry","f-dosimetry","f-isotope-supply","tc-99m","mo-99"],"indications":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["ema","mhra","pmda","snmmi","eanm"],"pathways":[],"terms":["medicare-ced"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["ASP reporting for diagnostic radiopharmaceuticals remains voluntary under the CY2026 OPPS rule; CMS says it intends to explore updated guidance but has not mandated reporting.","The $10 domestic-Mo-99 add-on payment (HCPCS C9176, effective 1 Jan 2026) replaced an earlier add-on tied to non-HEU production rather than country of origin — a policy shift toward reshoring rather than just proliferation-resistant production methods.","Regulatory and reimbursement timelines are not synchronised across the US, EU, UK and Japan, so global patient access to a newly approved radiopharmaceutical can lag its first approval by a substantial margin."],"order":12},"route":"/fronts/f-regulation-reimbursement/","neighbours":{"section":[{"id":"f-dosimetry","kind":"section","name":"Dosimetry","route":"/fronts/f-dosimetry/"},{"id":"f-isotope-supply","kind":"section","name":"Isotope supply","route":"/fronts/f-isotope-supply/"},{"id":"f-radiochemistry","kind":"section","name":"Radiochemistry & manufacturing","route":"/fronts/f-radiochemistry/"}],"isotope":[{"id":"mo-99","kind":"isotope","name":"Molybdenum-99","route":"/isotopes/mo-99/"},{"id":"tc-99m","kind":"isotope","name":"Technetium-99m","route":"/isotopes/tc-99m/"}],"institution":[{"id":"eanm","kind":"institution","name":"European Association of Nuclear Medicine","route":"/institutions/eanm/"},{"id":"ema","kind":"institution","name":"European Medicines Agency","route":"/institutions/ema/"},{"id":"mhra","kind":"institution","name":"Medicines and Healthcare products Regulatory Agency","route":"/institutions/mhra/"},{"id":"pmda","kind":"institution","name":"Pharmaceuticals and Medical Devices Agency","route":"/institutions/pmda/"},{"id":"snmmi","kind":"institution","name":"Society of Nuclear Medicine and Molecular Imaging","route":"/institutions/snmmi/"}],"term":[{"id":"medicare-ced","kind":"term","name":"Medicare coverage with evidence development","route":"/terms/medicare-ced/"}]}}