Proteomics International Laboratories (ASX: PIQ) has announced that the US Centres for Medicare & Medicaid Services (CMS) has set a US$390.75 reimbursement price for its ++PromarkerD++ predictive test for diabetic kidney disease.
The news follows American Medical Association (AMA) approval of a unique CPT Proprietary Laboratory Analyses (PLA) code, providing a dedicated billing pathway for the ground-breaking blood test.
The CMS price will take effect from 1 January 2026 for patients accessing government-funded healthcare through the US Medicare program.
Key Reimbursement Rate
The CMS reimbursement rate is important, as the agency is the single largest payer of healthcare in the US, with Medicare and Medicaid collectively responsible for approximately 42% of total healthcare expenditure.
Private health insurers frequently reference CMS pricing when setting their own reimbursement rates, further amplifying the commercial reach of the determination.
Proteomics expects CMS pricing is to strengthen discussions with private payers and strategic partners and promote broad clinical access to ProMarkerD.
PromarkerD is currently available in California through Proteomics International's
Clinical Laboratory Improvement Amendment (CLIA)-certified Reference Laboratory.
ProMarkerD Rollout
Proteomics managing director Dr Richard Lipscombe said the CMS determination represented a major milestone as the company ramps up the US rollout of ProMarkerD in the new year.
“The new CMS pricing and PLA code are pivotal to our next phase of commercialisation in the US, as they validate the clinical and economic value of our predictive test and ensure a clear reimbursement pathway for healthcare providers,” he said.
“We expect it will drive adoption, patient access, and commercial partnerships for ProMarkerD in the US.”
Dr Lipscombe said the company would now seek to obtain private health insurer coverage via the molecular diagnostic services program and a local coverage determination to establish the US regions that will receive Medicare rebates for ProMarkerD.
Early Identification
PromarkerD aims to identify patients with Type 2 diabetes at risk of developing diabetic kidney disease up to four years before clinical symptoms appear.
Early identification allows physicians to prescribe treatments such as renal-protective therapies, which have been shown to slow or prevent kidney function decline.
By delaying or preventing disease progression, PromarkerD has the potential to reduce the incidence of dialysis and kidney transplant, delivering substantial cost savings to healthcare systems and improving quality of life for an estimated 537 million adults worldwide.
The total annual cost burden of diabetic kidney disease in the US exceeds US$130 billion and highlights an urgent need for predictive diagnostics such as PromarkerD to support early intervention and preventive care.
