The Orphan Drug Imbroglio
The controversy over HRSA’s authority emerged late last year, when the agency published a legislative rule that sought to provide coverage for some uses of orphan drugs.
Federal prosecutors earlier this week filed a complaint against the Memphis Methodist health system, taking over a qui tam action initially filed by private whistleblowers, who alleged that Methodist’s six-year arrangement with West Clinic, an oncology private practice, violated the Anti-Kickback Statute and the False Claims Act.
