Physician Self-Referral Law
The Physician Self-Referral Law (42 U.S.C. § 1395nn), commonly referred to as the Stark law, prohibits physicians from referring patients to receive “designated health services” payable by Medicare or Medicaid from entities with which the physician or an immediate family member has a financial relationship, unless an exception applies. Financial relationships include both ownership/investment interests and compensation arrangements. A partial list of “designated health services” includes services related to clinical laboratory, physical therapy, radiology, parenteral and enteral supplies, prosthetic devices and supplies, home health care outpatient prescription drugs, and inpatient and outpatient hospital services. This list is not meant to be an exhaustive one.
Stark is a strict liability statute, which means proof of specific intent to violate the law is not required. The law prohibits the submission, or causing the submission, of claims in violation of the law’s restrictions on referrals. Penalties for physicians who violate the Stark law include fines, as well as exclusion from participation in federal health care programs. Like AKS, Stark law features its own safe harbors.
Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some materials may have been discussed in earlier columns. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. HHS Office of Inspector General. About OIG. https://oig.hhs.gov/about-oig/about-us/index.asp
2. HHS Office of Inspector General. OIG most wanted fugitives.
3. HHS Office of Inspector General. “Physician education training materials.” A roadmap for new physicians: Avoiding Medicare and Medicaid fraud and abuse.
4. HHS Office of Inspector General. Safe harbor regulations.