Blue Earth Diagnostics Praises New CMS Rule for Better Payment of Specialized Diagnostic Radiopharmaceuticals

MONROE TOWNSHIP, N.J., & Oxford, England--(BUSINESS WIRE)--Blue Earth Diagnostics, a company under Bracco, well-known for its pioneering efforts in PET radiopharmaceuticals, expressed its approval of the significant modifications announced by the Centers for Medicare & Medicaid Services (CMS) regarding the Hospital Outpatient Prospective Payment System (OPPS) Rule. These changes, unveiled on November 1, 2024, are set to be implemented from January 1, 2025, aiming to enhance the remuneration for diagnostic radiopharmaceuticals for patients covered by U.S. Medicare. The expected outcome is a broadened and sustained access to innovative radiopharmaceuticals.

Marco Campione, the CEO of Blue Earth Diagnostics, expressed satisfaction with the updates, acknowledging that these changes would enhance patient access to advanced diagnostic imaging solutions, which are crucial for patient management and treatment decisions. Campione underscored that this regulatory adjustment supports the innovation and sustainability of nuclear medicine and molecular imaging, which align with the company’s mission to provide top-tier radiopharmaceutical solutions for improving patient care.

Terri Wilson, President of Blue Earth Diagnostics, highlighted the company's longstanding advocacy for reimbursement reform concerning CMS's payment methods for diagnostic radiopharmaceuticals. She noted that the new rule rectifies a notable reimbursement gap that previously hindered the adoption of innovative radiopharmaceutical products and limited patient access. This adjustment benefits the company’s entire range of diagnostic imaging agents.

Specifically, POSLUMA® (flotufolastat F 18) will retain its current Pass-Through payment status until September 30, 2026. Additionally, Axumin® (fluciclovine F 18), which had lost its Pass-Through status in January 2020, will regain separate payment under the new rule. However, the updated payment methodology differentiates between Pass-Through and non-Pass-Through diagnostic radiopharmaceuticals for separate payment. Blue Earth Diagnostics’ reimbursement team is actively engaging with hospitals to ensure they comprehend the new rule and its impacts.

Regarding Axumin, which is used for PET imaging in men with suspected prostate cancer recurrence indicated by elevated PSA levels post-treatment, the company emphasized the possibility of image interpretation errors. A negative image does not necessarily exclude the recurrence of prostate cancer, and a positive image does not confirm it. PSA levels affect the performance of Axumin, and its uptake may also occur with other cancers and benign prostatic hypertrophy. Clinical correlation, possibly including histopathological evaluation, is advisable.

There are risks associated with Axumin, including hypersensitivity reactions like anaphylaxis, necessitating immediate availability of emergency resuscitation equipment and personnel. Axumin’s use contributes to cumulative radiation exposure, which is linked to an elevated risk of cancer. Safe handling practices are essential to minimize radiation exposure to both patients and healthcare providers. Adverse reactions in clinical studies were rare but included injection site pain, injection site erythema, and dysgeusia.

For POSLUMA, used for PET imaging of PSMA-positive lesions in men with prostate cancer, similar risks of image misinterpretation exist. The performance of POSLUMA is influenced by serum PSA levels and risk grouping. It is not exclusive to prostate cancer and may show uptake in various other cancers, non-malignant conditions, and normal tissues. Clinical correlation, including histopathological evaluation, is recommended to confirm the diagnosis.

POSLUMA also contributes to long-term cumulative radiation exposure, which increases cancer risk. Patients should be advised to stay hydrated and void frequently to mitigate radiation exposure. Safe handling practices are necessary to protect both the patient and healthcare providers.

Blue Earth Diagnostics, a subsidiary of Bracco Imaging, focuses on delivering innovative diagnostic solutions. Since its inception in 2014, the company has achieved notable success in developing and commercializing PET radiopharmaceuticals, particularly in oncology. Bracco Imaging, headquartered in Milan, is a global leader in diagnostic imaging, providing a comprehensive portfolio across various modalities and continually evolving its offerings to meet clinical needs.

This summary captures the essence of the announcements and regulatory changes that Blue Earth Diagnostics and Bracco Imaging are addressing as they continue to innovate and improve diagnostic imaging solutions.