USA District of Columbia Healthcare: Pharmaceutical/Medical Products Regulatory

Healthcare covers a wide range of work, including transactional, advisory, and contentious matters. Transactional work is primarily the sale and purchase, of some or all of a health system or health insurance company. Law firms advise on antitrust issues and assorted regulatory matters for clients such as hospitals, health systems and insurance companies. Litigation includes matters like qui tam (whistleblower) suits and the defence of parties involved in federal investigations. Advisory and regulatory compliance matters include Medicare Part D, the subsidizing of drugs through the federally-run Medicare program. Also covers Stark Law, which governs referrals of physicians accepting Medicare and Medicaid funds, and the False Claims Act (FCA). This chapter also features advice on pharmaceutical and medical products regulatory issues covering the drugs and devices approved by the FDA.