Diagnostics Policy & Legislation

News on government policy and legislation impacting life science and diagnostics.

The amicus briefs challenge the method in which HHS collected data to establish market-based Medicare prices and found flaws in a district court decision dismissing the case.

The discussion draft includes the regulatory proposals, including precertification, the FDA provided to legislators in a technical assistance document.

Factors that may have led to the explosion in testing include more consultations between patients and general practitioners, and a fear among GPs of being sued.

At the Personalized Medicine Conference this week, stakeholders historically at odds over lab test regulation said it is up to Congress to resolve the issue.

A tick-borne disease working group recommends the federal government explore using new technologies and repurposing existing ones to improve diagnosis.