Stark Self-Referral Laws and Regulations

In 1989, Representative Fortney “Pete” Stark of California authored H.R. 5198, a bill that proposed to prohibit physician “self-referral” for certain clinical laboratory services. The statutory provisions that passed related to clinical laboratory services became known as “Stark I.” These basic provisions were amended in 1993 in the Omnibus Budget Reconciliation Act of 1993. The amendments extended the referral ban to more physician services. These amendments related to other physician services became known as “Stark II.”

Stark generally prohibits a physician (or an immediate family member of such physician) who has a direct or indirect  financial relationship with an entity that provides a designated health service from making a referral for that service for which Medicare or Medicaid would otherwise pay. This very broad prohibition is mitigated by a large number of exceptions.  These exceptions must be met exactly. Failure to meet a Stark exception will result in a violation where the other requisites for a prohibited referral are met.  

For more information, see these publications in the TMA Education Center:      



NOTICE:  This information is provided as a commentary on legal issues and is not intended to provide advice on any specific legal matter.  This information should NOT be considered legal advice and receipt of it does not create an attorney-client relationship. This is not a substitute for the advice of an attorney.  The Office of the General Counsel of the Texas Medical Association provides this information with the express understanding that 1) no attorney-client relationship exists, 2) neither TMA nor its attorneys are engaged in providing legal advice and 3) that the information is of a general character. Although TMA has attempted to present materials that are accurate and useful, some material may be outdated and TMA shall not be liable to anyone for any inaccuracy, error or omission, regardless of cause, or for any damages resulting therefrom.   Any legal forms are only provided for the use of physicians in consultation with their attorneys.  You should not rely on this information when dealing with personal legal matters; rather legal advice from retained legal counsel should be sought.

Last Updated On

October 07, 2022

Originally Published On

March 23, 2010