There are differences between the Anti-Kickback Statute and Stark Law, and regulations provide “safe harbors” permitting certain arrangements. Significant experience with the statutes and regulations is often required to understand, analyze, and develop a False Claims Act case based on violations of them. Typically, however, the core analysis looks at a fundamental question: was something of value provided to induce health care referrals?
This “thing of value” can be as simple as cash, or as complex as a carefully constructed physician employment agreement, or the right to invest in a profitable joint venture. Anything of value to a person in a position to refer, such as cheap office space, patients referrals, a free employee, or a fat bonus, can classify as an illegal inducement under the Anti-Kickback and Stark Laws.
Classic examples of violations of Anti-Kickback and Stark Laws include:
- Hospitals, nursing homes, labs, dialysis centers, or drug companies paying kickbacks to doctors through big salaries or “consulting” fees to serve as medical directors, proctors, or “consultants,” where the doctors do little actual, useful work
- Hospitals, nursing homes, labs, dialysis centers, drug or DME companies offering doctors in a position to make referrals the opportunity to buy into surgical centers, distributorships, joint ventures, or other investment opportunities on favorable financial terms—especially if those terms depend on the amount of business the doctor will refer
- Hospitals paying their employed physicians salaries or “performance bonuses” tied directly or indirectly to the number of X-rays, lab tests, or procedures ordered at the hospital
- Hospitals, dialysis companies, or other providers buying physician practices for inflated prices, with a requirement that the physician continue to work at the practice and refer business to the hospital or dialysis company
- Hospitals offering physicians below-market-rate rent for office space, free access to clinical or administrative support staff, or other special deals on overhead expenses
- Drug companies, DME companies, and providers of skilled therapy paying nursing homes for long term contracts to provide services to nursing home patients, or giving the nursing homes free or low-cost access to consulting pharmacists, therapists, or other clinical or support staff to access their patient populations
- Drug companies paying kickbacks to pharmacies (retail or specialty) to get them to switch patients’ prescriptions
- Drug companies paying kickbacks to insurers to get on their formularies
- Payments by specialty pharmacies, DME suppliers, therapy centers, nursing homes, etc. to patient recruiters or patients directly