Interpace Expects to Stop Offering PancraGEN® Test Due to CMS Decision to End Reimbursement as of July 17, 2023
PARSIPPANY, NJ, June 05, 2023 (GLOBE NEWSWIRE) — Interpace Biosciences, Inc. (“Interpace” or the “Company”) (OTCQX: IDXG) today announced that the Centers for Medicare & Medicaid Services (CMS) issued the final Local Coverage Determination (LCD) of Genetic Testing for Oncology (L39365) which establishes non-coverage for the Company’s widely used PancraGEN® test effective July 17, 2023. Commercially available in its current form since 2013, PancraGEN is a DNA-based molecular diagnostic test that uniquely assesses the risk of pancreatic cancer posed by pancreatic cysts and is used to rule-in and rule-out (risk-stratify) the disease. The important information provided by PancraGEN helps support the differential diagnosis of pancreatic cancer by integrating the results of first-line tests and procedures with molecular test results. This insight aids physicians in their diagnosis of pancreatic cancer and helps inform the optimal management of patients, including through the reduction of unnecessary surgeries.
According to Tom Burnell, President and CEO of Interpace, “Pancreatic cancer, which primarily strikes Americans over the age of 65, has the highest mortality rate of all major cancers and is currently the 3rd leading cause of cancer-related deaths in the US. For the past decade, CMS has provided reimbursement for PancraGEN, and over that time nearly 70,000 patients have been tested on orders from physicians across the country. We are extremely disappointed that CMS, through its Medicare Administrative Contractor (MAC), Novitas, is ending coverage for PancraGEN—an important and widely utilized test. Because PancraGEN is primarily ordered for Medicare patients, Interpace will not be able to continue offering this test without Medicare reimbursement.”
Because of the high mortality rate of pancreatic cancer, surgery is often performed as a cautious approach to treat suspicious pancreatic cysts. Yet, studies have shown that 60% to 80% of surgeries reveal indolent cysts that did not necessarily require surgery. The surgery is also high-cost and subject to mortality and significant morbidity. First-line diagnostic tests and procedures—imaging, fluid chemistry (CEA, glucose, amylase), cytology, and patient risk factors— do not always provide a complete picture of malignancy risk. According to Interpace, the integrated molecular pathology approach provided by PancraGEN is an important tool that has helped to reduce the number of unnecessary surgeries for suspicious cysts.
Mr. Burnell added, “The Company will pursue every available option to reverse this decision prior to it becoming effective for dates of service beginning July 17, 2023.” He points out the test is currently still available and will remain in place until it is no longer economically feasible to offer following the elimination of reimbursement.
About Interpace Biosciences
Interpace Biosciences is an emerging leader in enabling personalized medicine, offering specialized services along the therapeutic value chain from early diagnosis and prognostic planning to targeted therapeutic applications.
Clinical services, through Interpace Diagnostics, provide clinically useful molecular diagnostic tests and bioinformatics and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for improved patient diagnosis and management. Interpace has five commercialized molecular tests and one test in a clinical evaluation program (CEP) PancraGEN® for the diagnosis and prognosis of pancreatic cancer from pancreatic cysts; PanDNA®, a “molecular only” version of PancraGEN that provides physicians a snapshot of a limited number of factors; ThyGeNEXT® for the diagnosis of thyroid cancer from thyroid nodules utilizing a next-generation sequencing assay; ThyraMIR®v2, used in combination with ThyGeNEXT®, for the diagnosis of thyroid cancer utilizing a proprietary microRNA pairwise expression profiler along with algorithmic classification; and RespriDX®, that differentiates lung cancer of primary versus metastatic origin. In addition, BarreGEN®, a molecular-based assay that helps resolve the risk of progression of Barrett’s Esophagus to esophageal cancer, is currently in a CEP, whereby we gather information from physicians using BarreGEN to assist us in gathering clinical evidence relative to the safety and performance of the test and also providing data that will potentially support payer reimbursement.
For more information, please visit Interpace Biosciences’ website at www.interpace.com.
PancraGEN® is a molecular cancer risk classifier for pancreatic cysts, solid lesions, and biliary strictures that have potential for pancreatic or bile duct cancer. The test uses a small sample of pancreatic cyst fluid or a duct brushing and aids cancer risk assessment. PancraGEN is 90% accurate according to clinical studies, enabling effective risk stratification of patients with pancreatic cysts and has been used in nearly 70,000 cysts since its commercial launch. PancraGEN utilizes integrated molecular pathology (IMP) which incorporates clinical and imaging data, fluid chemistry (carcinoembryonic antigen (CEA), glucose, and amylase), and multiple molecular markers evaluated using DNA sequencing. All elements are reviewed by molecular pathologists who assign each case a clinical risk stratification ranging from benign to malignant depending on the aggregate assessment encompassing all of these factors. The Company also offers a ‘molecular only’ version of PancraGEN called PanDNA® that only reports the molecular results, enabling physicians to conduct their own comprehensive clinical risk assessment.
Interpace Biosciences, Inc.