TEST:

PancraGEN®

"Interpace Diagnostics®...today announced that the Genetic Testing for Oncology (L39365) Local Coverage Determination (LCD) issued by the Medicare Administrative Contractor Novitas Solutions will go into effect, ending reimbursement for their PancraGEN® test. The Centers for Medicare & Medicaid Services (CMS) delayed implementation by 60 days earlier in the year and confirmed finalization of the LCD as of today, April 24, 2025."

"Interpace Diagnostics®…today announced notification that the Centers for Medicare & Medicaid Services (CMS) directed its Medicare Administrative Contractors, Novitas and First Coast Service Options, Inc., to delay implementation of the Genetic Testing for Oncology Local Coverage Determination (LCD) (L39365), from February 23, 2025, to April 24, 2025...This change of effective date will allow the incoming Trump administration time to fully review the proposed policy changes, re-evaluate for themselves the supporting clinical evidence for the PancraGEN® assay, and fully assess the negative impact on patient care if the currently proposed LCD comes into effect."

"Interpace Diagnostics®, a subsidiary of Interpace Biosciences...today responded to the final Local Coverage Determination (LCD) of Genetic Testing for Oncology (L39365) issued by the Centers for Medicare & Medicaid Services (CMS). The new LCD establishes non-coverage for the Company’s widely used PancraGEN® test."

"Interpace Diagnostics, a subsidiary of Interpace Biosciences...responded to the undefined extension granted by Centers for Medicare & Medicaid Services (CMS) to Novitas, its Medicare Administrative Contractor (MAC). Novitas announced late last week that CMS granted an extension to the final decision for Local Coverage Determination (LCD) of Genetic Testing for Oncology (L39365) in order for all comments received in response to the proposed changes to be thoroughly considered."

However this study shows the increase in sensitivity in detection of cysts with IPMN/MCN pathology by combining size CEA and DNA analysis. These findings can validate serial surveillance by EUS with FNA as DNA and CEA levels can morph over time and also provide improved guidance on potential premalignant mucinous cysts.

"On July 6, 2023, Novitas Solutions, Inc. announced that it was rescinding implementation of the Genetic Testing for Oncology LCD (L39365) so that it will not become effective on July 17, 2023. As a result, Interpace is able to continue offering PancraGEN..."

"Interpace Biosciences, Inc...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."