Protecting Your Healthcare Business from Legal Pitfalls
Anti-Kickback Statute
The federal Anti-Kickback Statute makes it a crime to offer, pay, solicit, or receive anything of value to induce or reward referrals of items or services covered by Medicare, Medicaid, or any other federal healthcare program. Both sides of the transaction are potentially liable. And the penalties are serious: up to ten years in prison per count, civil monetary penalties, and permanent exclusion from federal programs.
In fiscal year 2025, the Department of Justice recovered nearly $6.9 billion under the False Claims Act — a single-year record — with healthcare-related recoveries reaching approximately $5.7 billion, or 83% of the total. Pfizer paid $60 million in January 2025 to resolve AKS allegations involving speaker fees. Gilead paid $202 million four months later for similar conduct. A record 1,297 qui tam whistleblower lawsuits were filed that year.
If you’re in healthcare — as a provider, device company, pharmaceutical manufacturer, staffing firm, or investor — this is the enforcement environment you’re operating in right now.
Navigating Anti-Kickback Compliance
Most AKS violations don’t start as obvious bribery. They start as arrangements that made business sense and weren’t carefully reviewed against the statute. Speaker programs that reward high-prescribers rather than medical educators. Consulting arrangements that pay for access, not genuine expertise. Below-market office leases to referral sources. Waiving copays as a patient attraction strategy.
There are regulatory safe harbors — protections for arrangements structured to meet specific requirements. But they’re narrower than most people think. Partial compliance provides no protection. An arrangement that almost fits the rental safe harbor is still an illegal kickback.
The False Claims Act exposure multiplies the risk substantially. Under the FCA, every Medicare or Medicaid claim resulting from an AKS violation is a false claim — even if the service was genuinely delivered and medically necessary. Each claim is independently actionable, with treble damages plus per-claim penalties now exceeding $27,000. For a busy practice, that math can be existential.
What We Offer
- Compliance reviews — Analyze referral arrangements, speaker programs, medical directorship agreements, and compensation structures against the safe harbors and OIG guidance
- Safe harbor structuring — Design or restructure arrangements to qualify for regulatory protection, documented with defensible rationale
- Investigation defense — Represent clients in DOJ and OIG investigations, False Claims Act litigation, and administrative proceedings
- Voluntary disclosure — Guide clients through the OIG and DOJ voluntary self-disclosure programs when proactive resolution is the right move
- Risk assessment — Identify and remediate problematic arrangements before an investigation begins
If you’ve received a subpoena, a civil investigative demand, or a request for voluntary interviews, contact us. The decisions made in the first weeks of a healthcare fraud investigation have consequences that last years. We work in Texas, DC, Colorado, and California, with affiliated counsel wherever an investigation is centered.
Our Services
Related: Stark Law
The Stark Law prohibits physicians from referring Medicare or Medicaid patients to entities with which they have a financial relationship. We help healthcare providers structure their arrangements to stay compliant and avoid severe penalties. Our legal insight safeguards your practice while promoting ethical care delivery.
Let’s Ensure You’re Fully Compliant
The Anti-Kickback Statute intersects with the Stark Law (which separately prohibits certain physician self-referral arrangements) and with state-level anti-kickback statutes, many of which have no safe harbors at all. A compliance program that addresses the federal statute but ignores state law leaves significant exposure unaddressed.
We also represent whistleblowers — employees, former employees, and compliance officers — who have witnessed AKS violations and are considering a qui tam filing. These cases are filed under seal and investigated by the government before anything becomes public. See our Whistleblower Representation page for more on how that process works.