The Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Balanced Budget Act of 1997 created new healthcare fraud and abuse laws, increased government penalties for fraud and abuse violations, and instituted many new payment systems for providers under the Medicare and Medicaid Programs. The Office of Inspector General (OIG) of the Department of Health and Human Services has expanded all of these laws and restrictions to cover indirect providers, including drug and device manufacturers. This new regulatory paradigm affects every aspect of marketing, promotion and pricing of drug and device products.
We assist on all of these healthcare regulatory matters, including reimbursement, fraud and abuse, physician self-referral, marketing/promotion and pricing matters. Our role often results in helping our clients implement a compliance program to prevent and detect healthcare fraud and abuse.
In order to reduce the potential of government enforcement action in this area, we regularly advise manufacturers on the risks involved in drug sales and marketing decisions, including drug promotional programs, educational grants, value-added services and volume purchasing arrangements. We also advise on the healthcare regulatory implications of business transactions with Internet companies regulated by state boards of pharmacy and federal/state healthcare programs. We help in developing and implementing compliance programs, highly recommended by OIG, and we provide strategic assistance in connection with business ventures concerning physicians’ groups and other healthcare providers.
On the healthcare reimbursement end, we assist with healthcare regulatory aspects of reimbursement issues for federal and state healthcare programs. We also advise on drug and device coverage issues under Medicare/Medicaid and other federal healthcare programs.