AdvaMedDx: Inclusion Of LDTs In Cures Bill Uncertain, Depends On Stakeholder Engagement

The head of the Advanced Medical Technology Association's diagnostic arm says it is uncertain whether the House will broach FDA's role in laboratory-developed tests as part of its Cures bill, telling Inside Health Policy that lawmakers could end up sidestepping the issue if key stakeholders do not engage in discussions. The official from AdvaMed, which generally supports FDA's plan to oversee LDTs, points to signals that Energy and Commerce health panel Chair Joe Pitts (R-PA) believes there are public...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.