regulatory
confidence high
sentiment negative
materiality 0.75
CMS final LCD denies coverage for Interpace's PancraGEN test; company to discontinue after Feb 7, 2025
INTERPACE BIOSCIENCES, INC.
- CMS issued final LCD L39365 establishing non-coverage for PancraGEN, a DNA-based test assessing pancreatic cyst cancer risk.
- Interpace will stop accepting PancraGEN specimens after February 7, 2025; test primarily ordered for Medicare patients.
- PancraGEN has helped over 80,000 patients since 2013; CEO calls decision inconsistent with advancing patient care.
- Company plans restructuring but expects to remain profitable with ThyGeNEXT + ThyraMIR v2 thyroid tests.
- Interpace will consider all remedies against CMS/Novitas regarding the non-coverage decision.