AS SCRUTINY INTENSIFIES, GROUP CALLS FOR OIG GUIDANCE ON PHYSICIANS' FINANCIAL TIES TO INDUSTRY
To help device firms remain in compliance with Medicare and Medicaid regulations, AdvaMed is asking HHS' Office of Inspector General (OIG) for clearer guidance on physician investments in firms that make or distribute devices.
The Sept. 6 letter to the agency from AdvaMed President and CEO Stephen Ubl comes after a slew of regulatory and legal actions aimed at weakening the ties between industry and physicians who act as device consultants.
Interestingly, physicians have equity ownership interests in companies and generate substantial portions of the revenue, noted Ubl. This "raises important legal and policy issues in relation to the potential effect on clinical decisions by physicians."
Ubl has cause for concern. Enforcement actions are on the rise against device firms over their relationships with physicians, some resulting in major settlements such as the $40 million paid by Medtronic in a whistleblower case brought by the Department of Justice.
Furthermore, congressional inquiries into potential conflicts of interest between physicians serving on FDA advisory committees and devicemakers whose products are up for approval compelled the agency to announce an upcoming guidance on the issue.