US Medicare Confirms Reimbursement Price for PromarkerD
Perth, Nov 22, 2023 AEST (ABN Newswire) - Proteomics International Laboratories Ltd (ASX:PIQ) is pleased to announce that the US Centers for Medicare & Medicaid Services (CMS) has published its final determination of the national reimbursement price in the United States for the PromarkerD predictive test for diabetic kidney disease.
The CMS is the federal agency in the United States that is responsible for providing health coverage to more than 100 million Americans through Medicare and Medicaid. The reimbursement rate set by CMS applies to all patients accessing government-funded healthcare in the United States. Medicare covers health care costs for people over the age of 65, while Medicaid covers eligible low-income Americans. CMS is the single largest payer for health care in the United States, with Medicare and Medicaid collectively responsible for 42 per cent of healthcare spending. CMS has assigned a payment rate of US$390.75 for PromarkerD [ASX 29 September], which is to be delivered through Sonic Healthcare USA [ASX 10 May]. The rate, set by the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests, follows a period of public comment and will become effective from 1 January 2024.
Proteomics International Managing Director Dr Richard Lipscombe said, "As we prepare for the US launch of PromarkerD, the CMS price is an essential component of the roll-out strategy, both because of the number of people it covers, and because many private payers follow CMS pricing."
The reimbursement price comes after the American Medical Association (AMA) approved a unique CPT(R) Proprietary Laboratory Analyses (PLA) code 0385U for PromarkerD earlier this year [ASX 3 January].
Globally there are 537 million adults living with diabetes. In the United States an estimated 32 million people-or 11 per cent of the adult population-live with diabetes and in Europe 61 million (7%) live with diabetes. The total cost of diabetic kidney disease (DKD) is US$130 billion per year in the US alone, according to the US Renal Data System.
The PromarkerD predictive test can identify kidney function decline in type 2 diabetes patients up to four years before clinical symptoms appear. Patients identified as at high-risk of DKD by PromarkerD could then be prescribed early therapeutic interventions such as SGLT2-inhibitors or potentially GLP-1 agonists to slow or stop the onset of disease; SGLT2-inhibitors are widely used diabetes drugs, now also indicated for the treatment of DKD, and recently the GLP-1 agonist, semaglutide (Ozempic(R)) was also found to be renal protective [ASX PIQ September Quarterly, 26 October]. Published research shows early intervention with an SGLT2-inhibitor class drug leads to a significant reduction in the PromarkerD risk scores for developing DKD [ASX 3 May].
PromarkerD has the potential to be used a complementary diagnostic test. Early diagnosis of DKD using PromarkerD could help inform doctors' treatment decisions to improve clinical outcomes for patients by increasing adoption of renal-protective interventions in patients at high risk for kidney decline, whilst lowering the likelihood of aggressive treatment in those at low risk [ASX 2 August 2022]. Reducing or delaying the progression of the disease would reduce the incidence of dialysis and kidney transplant, improving quality of life for patients and saving healthcare systems millions of dollars.
About Proteomics International Laboratories Ltd
Proteomics International Laboratories (ASX:PIQ) is a wholly owned subsidiary and trading name of PILL, a medical technology company at the forefront of predictive diagnostics and bioanalytical services. The Company specialises in the area of proteomics - the industrial scale study of the structure and function of proteins. Proteomics International's mission is to improve the quality of lives by the creation and application of innovative tools that enable the improved treatment of disease.