The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Podcast: Direct Access Laboratory Testing - Physician Orders and Specimen Collection - Diagnosing Health Care
Podcast: Direct Access Laboratory Testing: Reimbursement & Compliance – Diagnosing Health Care
COVID Laboratory Testing Investigations
IN THIS ISSUE Home medical tests and health monitors are trendy now. How useful are they? As the saying goes: Let the buyer beware - Shaking up hidebound medicine could be a plus. But will key safeguards also stay?...more
Celebrating its sixth program, McDermott+Consulting’s +Dx Diagnostics Forum is the premier annual program for the laboratory diagnostics community. Gain insight into how the industry addresses regulatory and business...more
Back in the early days of the COVID-19 pandemic, we published a post outlining the different kinds of diagnostic tests that were being marketed and the different roles of the two main federal regulators that oversee the...more
As the U.S. continues to struggle to make COVID-19 tests available for symptomatic and asymptomatic individuals, FDA’s position regarding COVID-19 test standards is evolving. The FDA’s pivot is possibly a response to...more
On June 23, 2020, the US Departments of Labor, Health and Human Services, and Treasury issued tri-agency FAQs (Part 43) that clarify important health and welfare provisions under the Families First Coronavirus Response Act...more
In this week’s episode, Kenneth Kennedy discusses several of FDA’s strategies for helping stakeholders in the drug and medical device industry support health care providers in their fight against the COVID-19 outbreak. In...more
The Food and Drug Administration (FDA) announced a policy shift on March 16, 2020, to allow state health departments to approve COVID-19 (coronavirus) diagnostic tests without FDA involvement during the current public health...more
• The new national Medicare coverage determination covers only FDA-authorized NGS tests with companion diagnostic indications, leaving NGS cancer tests without that specific indication to seek coverage from local Medicare...more