Stark Definition: Immediate Family Member - Spouse, natural or adoptive parent, children or
siblings, step-siblings, in-laws, grandparents/grandchildren.
Anti-Kickback Statute (AKS) - Prohibits anyone from purposefully offering, soliciting, or receiving
anything f value to generate referrals for items or services payable by any federal health program
(Medicare, Medicaid, Tri-Care). 42 states and D.C. have their own AKS.
After discovering Stark Law non-compliance... - put a bill-hold immediately.
AKS Definition: Remuneration - 1. anything of value
2. "in-cash or in-kind"
3. Paid directly or indirectly
ex: cash, free goods, discounts, below market rent, relief of financial obligations
AKS Elements - 1. Remuneration
2. Intent + Offered, paid, solicited or received
3. Knowingly and willfully
4. To induce or in exchange for federal program referrals
AKS Exceptions/Safe Harbors - 24 exceptions created by OIG. Must meet all conditions to qualify.
Ex: investment interests, space rental, equipment rental, sale of practices, referral services, discounts,
warranties, employees, etc.
AKS Fines/Penalties - Administrative - Monetary penalty up to $50,000 per violation and
assessment of up to 3 times remuneration. Discretionary exclusion. Brought by OIG.
AKS Fines/Penalties - Criminal - Felony, imprisonment up to 5 years and fine up to $25,000.
Mandatory exclusion for participating federal health care programs. Brought by the DOJ