The agency addressed industry stakeholder's concerns about its proposed diagnostic regulatory framework at the American Clinical Laboratory Association's annual meeting.
Industry organizations like ACLA are seeking changes to the bill, which appears to outlaw standard business practices such as paying sales staff on commission.
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.
