Blue Earth Diagnostics Praises CMS Proposal for Better Access to Diagnostic Radiopharmaceuticals

Bracco and Blue Earth Diagnostics Ltd, a company renowned for its innovative PET radiopharmaceuticals, have welcomed a significant announcement by the Centers for Medicare & Medicaid Services (CMS) on July 10, 2024. The proposed changes in the Hospital Outpatient Prospective Payment System (OPPS) Rule aim to enhance payment structures for diagnostic radiopharmaceuticals for Medicare patients in the U.S., potentially broadening access to novel radiopharmaceuticals that no longer qualify for Transitional Pass-Through payment status. Blue Earth Diagnostics has been instrumental in initiating discussions with CMS to bring about these changes.

Marco Campione, CEO of Blue Earth Diagnostics, expressed enthusiasm about the proposed rule, emphasizing that it would improve patient access to advanced diagnostic imaging products, facilitating better patient management while fostering industry innovation and sustainability. Terri Wilson, President of Blue Earth Diagnostics, Inc., highlighted that the limitations of the previous CMS payment methodology had long impeded the adoption and accessibility of innovative radiopharmaceutical products. The new rule is set to support Blue Earth Diagnostics' entire portfolio of diagnostic imaging agents. For instance, POSLUMA (flotufolastat F 18) will retain its Pass-Through payment status for reimbursement until September 30, 2026. Additionally, Axumin (fluciclovine F 18), which lost its Pass-Through status in January 2020, will regain separate payment upon the rule's passage.

The proposed OPPS rule will undergo further refinement during a 60-day comment period. Blue Earth Diagnostics looks forward to continued collaboration with CMS to finalize the separate payment rates, which will differ from those under the Transitional Pass-Through, develop a model for future adjustments, and ensure the rule's successful implementation. The final rule is expected to be issued in early November 2024, with an effective date of January 1, 2025.

Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is dedicated to advancing innovative diagnostic solutions in molecular imaging. Founded in 2014, the company's growth is propelled by its management expertise and a proven track record in the rapid development and commercialization of PET radiopharmaceuticals. Blue Earth Diagnostics' expanding oncology portfolio includes products for prostate cancer and neuro-oncology, emphasizing the timely development and commercialization of precision radiopharmaceuticals for potential use in imaging and therapy.

Bracco Imaging S.p.A., a part of the Bracco Group and headquartered in Milan, Italy, is a global leader in diagnostic imaging. The company specializes in developing, manufacturing, and marketing diagnostic imaging agents and solutions across various modalities, including X-ray imaging, MRI, Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and PET imaging agents. Bracco Imaging's portfolio is complemented by a range of medical devices, advanced administration systems, and dose-management software. In 2019, Bracco Imaging expanded its oncology nuclear imaging solutions in the urology segment with the acquisition of Blue Earth Diagnostics. Furthering its commitment to innovation, Bracco Imaging established Blue Earth Therapeutics in 2021 as a separate biotechnology entity to develop radiopharmaceutical therapies.

These proposed changes and the continuous efforts of Blue Earth Diagnostics and Bracco Imaging highlight an ongoing commitment to improving diagnostic imaging and patient care, ensuring that innovative radiopharmaceuticals remain accessible and sustainable for the broader medical community.