The AntiKickback Statute and Marketing（AntiKickback法规和市场营销）.pdf

The Anti-Kickback Statute and Marketing April 2013 Anjana D. Patel, Esq. Vice-Chair, Health Care Practice Group Sills Cummis Gross, P.C. (973) 643-5097 apatel@ Overview • The AKS statute and regulations don’t tell the whole story – Additional Guidance: OIG Opinions Case Law – Very fact-intensive scrutiny • Recent trends: Internet-based marketing 2 2 | AKS and Marketing Beyond The Statute Regulations • Additional guidance/compliance strategies comes from OIG Advisory Opinions OIG compliance guidance, case law, industry guidance (e.g. Phrma Code) • OIG oversees fraud, waste, and abuse of federally funded health care programs (e.g. Medicare, Medicaid) – Providers submit business arrangements to OIG • Analysis of the particular facts presented • Opinions apply only to those facts but they provide general guidance for industry 3 3 | AKS and Marketing OIG Advisory Opinions - Overview • OIG focuses on services “particularly susceptible” to overutilization (e.g. DME). OIG Advisory Opinion No. 10-14 • OIG focuses on marketing activities involving personal contact with beneficiaries (especially when targeted at elderly, Medicaid patients, other vulnerable patients). OIG Advisory Opinion No. 08-20 – door-to-door marketing – telephone solicitations – direct mailings – in-person sales pitches or ‘information’ sessions 4 4 | AKS and Marketing Relevant OIG Opinions • “Per-click” or commission-based compensation – Marketing $ awarded based on successful orders of items / services – OIG Adviso