NEW YORK – The US Centers for Medicare & Medicaid Services (CMS) on Friday announced that it will separately reimburse for certain high-cost diagnostic radiopharmaceuticals in the outpatient setting.
Under the Hospital Outpatient Prospective Payment System, "the payment for diagnostic radiopharmaceuticals is packaged into the payment for the nuclear medicine tests they are used with," CMS said in a statement last week after releasing its 2025 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System final rule. "While this payment approach generally works appropriately to support efficient care, we recognize that, in some specific circumstances, the payment amount for the nuclear medicine tests may not adequately account for the cost of certain high-cost diagnostic radiopharmaceuticals, even when those agents may be the most clinically appropriate."
In the final rule, CMS said that starting in 2025, it will pay separately for any specialized diagnostic radiopharmaceutical that does not have pass-through payment coverage status and that based on its mean unit cost (MUC), calculated using hospital claims data, has a threshold per day cost greater than $630. Any qualifying high-cost diagnostic radiopharmaceuticals will have to wait until their transitional pass-through payment period expires before they can be reimbursed under the new payment policy.
Any diagnostic radiopharmaceutical with a per-day cost of $630 or lower, however, will continue to be packaged into the payment for nuclear medicine tests. "This update should address challenges for patients in accessing these prescribed nuclear medicine tests with higher-cost radiopharmaceuticals," CMS stated.
Following CMS's announcement, Telix Pharmaceuticals, which markets a high-cost diagnostic radiopharmaceutical, Illuccix (Ga-68 PSMA-11), championed this change in coverage policy. Telix said Monday that the change will ensure consistent coverage for Illuccix for patients covered under Medicare Fee for Service.
Illuccix is approved in the US as a diagnostic imaging agent to identify prostate-specific membrane antigen (PSMA)-expressing metastatic castration resistant prostate cancer patients who are eligible for treatment with Novartis' therapeutic radiopharmaceutical, Pluvicto (lutetium vipivotide tetraxetan). Melbourne, Australia-based Telix also said CMS's move will drive purchasing decisions based on evidence of utility rather than reimbursement structure.
For its part, Illuccix's pass-through payment status is set to expire on July 1, 2025, at which point it will benefit from CMS's new coverage policy. The shift in policy will also apply to other diagnostic radiopharmaceutical agents in Telix's pipeline, should they net US Food and Drug Administration approval and CMS coverage. These would include TLX007-CDx, a new product under development for PSMA imaging in prostate cancer; TLX250-CDx, in development for kidney cancer imaging; and TLX101-CDx, in development for brain cancer imaging.
"Telix welcomes the decision by CMS to unbundle payments for diagnostic radiopharmaceuticals, as it will provide certainty for patients and physicians seeking access to safe and effective diagnostic radiopharmaceuticals," Kevin Richardson, CEO of precision medicine at Telix, said in a statement. He added that the firm also believes the shift in coverage policy will encourage firms to invest in new imagining agents by providing a clearer path to recouping their investment.
Bracco subsidiary Blue Earth Diagnostics also lauded the final rule on Monday, saying that it will increase access to the diagnostic imaging agents in its portfolio, including Posluma (flotufolastat F 18), which has pass-through payment status until Sept. 30, 2026, and Axumin (fluciclovine F 18), which previously had pass-through payment status until January 2020.
Posluma is approved as a diagnostic PET imaging agent for patients with PSMA-expressing prostate cancer, and Axumin is approved as a diagnostic PET imaging agent for patients with suspected prostate cancer based on elevated prostate specific antigen.
"This rule corrects a significant reimbursement gap that previously hampered the adoption of innovative radiopharmaceutical products and patient access," Blue Earth Diagnostics President Terri Wilson said in a statement.