Court denies review of oncology genetic testing

The US District Court for the Middle District of Pennsylvania has ruled that it does not have jurisdiction to conduct a judicial review of the Local Coverage Determination (LCD) for genetic testing in oncology.

This judgement means that the court cannot consider the merits of Pacific Edge's legal complaint filed in February 2025.

The company has now said that the only remaining avenue for the LCD not to become effective on April 24, 2025, in the US is a policy action by the Centers for Medicare and Medicaid Services (CMS).

CMS has the authority to unilaterally extend the effective date of the LCD, independent of the court's ruling.

Pacific Edge said it has made the case for the retirement of the LCD or extension of the effective date to the incoming political appointees within CMS, the Department of Health and Human Services, and the Office of the General Counsel.

The company said it is now monitoring the situation closely and will provide updates as it receives further information.