Diagnostics Policy & Legislation

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

The registry from the American Society for Clinical Pathology aims to eventually collect metrics on how lab services impact patient outcomes.

Lab industry groups hope to change CMS's controversial 2016 decision allowing nurses to perform complex lab tests.

The FDA's draft document noted that it is providing additional clarity to help itself and manufacturers better apply the concepts in a 2003 guidance document.

Lipid panel prices and prices for tests formerly bundled together as automated testing profiles are expected to rise in 2018, but fall in 2019.

Project would be managed by the US Centers for Disease Control and Prevention and would require tests from different manufacturers produce the same results.