Anti-Kickback Statute (AKS)
Last reviewed · By Chad Griffith
The Anti-Kickback Statute at 42 USC 1320a-7b(b) makes it a felony to knowingly and willfully offer, pay, solicit, or receive remuneration to induce or in return for: referring an individual for service or item paid by a federal healthcare program; or purchasing, leasing, or ordering any item or service paid by a federal healthcare program. Penalties include imprisonment up to 10 years, criminal fines up to $100,000 per violation, civil money penalties up to $135,000 per violation under 2026 inflation-adjusted amounts, exclusion from federal healthcare programs, and treble damages under the False Claims Act. OIG-published safe harbors at 42 CFR 1001.952 provide protection from AKS prosecution for arrangements meeting all the safe harbor's requirements.
Frequently Asked Questions
What is the difference between AKS and Stark?
Three key differences: (1) AKS requires intent ('knowingly and willfully'); Stark is strict liability — no intent required. (2) AKS applies broadly to any federal healthcare program (Medicare, Medicaid, Tricare, etc.) and any service or item; Stark applies only to physician referrals for designated health services payable by Medicare. (3) AKS is criminal as well as civil; Stark is civil only. AKS also extends to non-physician parties (manufacturers, vendors, marketers) — Stark applies only to physician referrals.
What are the most-relevant AKS safe harbors?
Common safe harbors at 42 CFR 1001.952: (a) Investment interests; (b) Space rental; (c) Equipment rental; (d) Personal services and management contracts; (e) Sale of practice; (f) Referral services; (h) Discounts; (i) Employees; (j) Group purchasing organizations; (n) Practitioner recruitment; (r) Investment interests in underserved areas; (s) Ambulatory surgical centers; (t) Referral arrangements for specialty services; (z) Employee compensation arrangements. Each safe harbor has detailed requirements that must all be satisfied.
What are 'one purpose' and 'small risk' tests?
Court interpretation of AKS: the 'one purpose' test (United States v. Greber and similar cases) holds that if even one purpose of an arrangement is to induce referrals, AKS is violated, regardless of other legitimate purposes. The 'small risk' test sometimes applied is that arrangements creating only a small risk of inducement may not violate AKS, but courts have not consistently applied this narrowing interpretation. Most arrangements are evaluated under the 'one purpose' standard, making intent analysis critical.
What is an OIG advisory opinion?
The HHS OIG accepts requests for advisory opinions on whether specific proposed arrangements violate AKS. Advisory opinions are binding on OIG only with respect to the requesting party and the specific facts presented. The opinion process takes 60-100 days. Advisory opinions are publicly published and provide useful precedent for similar arrangements. The OIG also publishes Special Fraud Alerts and Special Advisory Bulletins highlighting categories of arrangements that raise compliance concerns. Costs: the OIG advisory opinion process has a filing fee plus the entity's legal costs.
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