Telix Supports CMS Proposal for Better Payment of Specialized Diagnostic Radiopharmaceuticals

MELBOURNE, Australia, July 11, 2024 – Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) has expressed strong support for the recent proposed changes by the Centers for Medicare & Medicaid Services (CMS) regarding the Hospital Outpatient Prospective Payment System (OPPS). These changes aim to enhance payments for diagnostic radiopharmaceuticals for Medicare patients in the U.S., ensuring sustained patient access after the current transitional pass-through payment status concludes.

The new proposal indicates that diagnostic radiopharmaceuticals, including Illuccix®, will continue to receive separate payments from CMS for traditional Medicare Fee for Service patients in hospital outpatient settings once the transitional pass-through payment status expires. This policy would also extend to any new diagnostic products developed by Telix, pending approval. Currently, the costs for diagnostic radiopharmaceuticals in the U.S. are bundled into the payment for nuclear medicine tests (scans). The CMS's proposed refinements aim to improve the accuracy of overall payment amounts by providing separate payments for any diagnostic radiopharmaceutical with a per-day cost exceeding US$630.

Kevin Richardson, CEO of Telix Americas, praised the proposed rule, highlighting its potential to provide more equitable and reliable access to advanced imaging for all patients and to support physicians in prescribing the most clinically appropriate solutions. He commended CMS and the coalition, along with patient advocacy groups, for their proactive efforts to reform the payment system to enhance patient outcomes. Richardson emphasized Telix’s dedication to ongoing innovation in radiopharmaceutical diagnostics, aiming to create new solutions to improve patient access, particularly for underserved populations and areas with significant unmet clinical needs.

The proposed OPPS rules are published annually and include a 60-day comment period, concluding on September 9, 2024. The final rule is expected to be issued in early November 2024 and will take effect on January 1, 2025.

Telix Pharmaceuticals Limited is a biopharmaceutical company that focuses on developing and commercializing therapeutic and diagnostic radiopharmaceuticals and associated medical devices. Headquartered in Melbourne, Australia, Telix operates internationally, with branches in the United States, Europe (Belgium and Switzerland), and Japan. The company is working on a portfolio of clinical and commercial stage products aimed at addressing significant unmet medical needs in oncology and rare diseases. Telix is publicly listed on the Australian Securities Exchange (ASX: TLX).

Telix’s leading imaging product, gallium-68 (68Ga) gozetotide injection (marketed as Illuccix®), has received approval from the U.S. Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA), and Health Canada. No other Telix products have obtained marketing authorization in any jurisdiction.

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