Safe Harbors and Healthcare Compliance
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Safe Harbors Explained
In healthcare, a safe harbor is a recognized exception to the Anti-Kickback Statute. While the Anti-Kickback Statute prohibits financial relationships between referral sources and business partners in general, safe harbors offer avenues to structure the exchange of remuneration in a legal fashion. Safe harbors are regulations issued in intervals since 1991 by the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS). Safe harbors are regulated in 42 C.F.R. Sect. 1001.952 and include the following concepts:
- Investment interests in publicly traded companies and small private entities
- Renting and leasing of space
- Renting and leasing of equipment
- Personal services and management agreements
- Employee compensation arrangements
- Sale of physician practice with separate standards for sales of practices from physician to physician or from physician to hospital and other entities
- Referral services such as vendor agreements
- Discounts for buyers, sellers, and offerors not acting as sellers
- Group purchasing organization that receives payment from a vendor for goods or services
- Practitioner recruitment
- Investments in group practices and solo practices
- Referral arrangements for specialty services
- Certain price reductions
- Electronic health records items and services involving non-monetary goods and services
Advantage and Use of Safe Harbors
Safe harbor compliance protects from federal civil and criminal prosecutions as well as from civil money penalties and possible exclusion from participation in Medicare, Medicaid, and other federally funded health programs. While a failure to comply with all elements and criteria of an applicable safe harbor does not automatically render the arrangement illegal, deviations from safe harbors do provide law enforcement greater prosecutorial discretion to investigate and possibly prosecute the participants. Of critical importance in such an analysis is the intent that the parties had or displayed surrounding and executing the arrangement. Because the safe harbor originates as an exception to the Anti-Kickback Statute, which is a criminal statute based on intent, the intent of the involved parties can become the decisive factor in determining the lawfulness of the venture.
In case an arrangement violates the Anti-Kickback Statute and falls outside a safe harbor, the case can quickly turn into a criminal investigation. Violations of the Anti-Kickback Statute constitute felonies, and, as such, can result in severe monetary fines as well as incarceration. Furthermore, anyone convicted of violating the Anti-Kickback Statute will be excluded from reimbursement for serving federally funded patients.
Healthcare entrepreneurs and medical professionals interested in learning more about making strategic use of safe harbors in a clean and compliant fashion should contact one of our experienced attorneys for a free and confidential consultation. Our firm serves clients throughout the United States.
- Nick Oberheiden represents clients on both corporate compliance and in federal healthcare investigations. Dr. Oberheiden’s profound healthcare law understanding has allowed him to achieve no civil and no criminal liability results for physicians and healthcare executives in proceedings before the Office of Inspector General (OIG), the Department of Health and Human Services (HHS), the Department of Justice (DOJ), and the Department of Labor (DOL), and he has defended Stark Law, False Claims Act, and Anti-Kickback cases across the country.