• Laxmaiah Manchikanti and Erin Brisbay McMahon.
• Pain Management Center of Paducah, KY, USA. drm@asipp.org
• Pain Physician. 2007 Nov 1;10(6):725-41.

AbstractThe United States spends more of its wealth on healthcare than any other developed country, and that share is rising. Supporters of the free market system point to the regulatory burden on the healthcare industry. Estimates of the regulatory costs of US healthcare range from dollars 58 billion to dollars 339 billion. A recent report indicates that approximately dollars 8 billion of the US healthcare budget of dollars 1.9 trillion is spent on physicians' extra income derived from their ownership in outpatient facilities, such as ambulatory surgery centers, diagnostic imaging centers, and diagnostic testing and procedure laboratories. It is essential for an interventionalist to understand fraud and abuse, self-referrals, and the implications of the Stark law and anti-kickback statutes, among a maze of other regulations. It is important for interventionalists to understand and also be able to invest in protected and approved investments and also be involved in business dealings which are within the law. Various reasons include: decreasing reimbursements by Medicare, Medicaid, managed care, and all other third-party payors; increased competition in providing interventional pain management; increasing costs of overhead and doing business; the popularity of interventional pain management, leading each and every pain physician to want to provide the service; concerns in multiple settings, including offices, ambulatory surgery centers (ASCs), hospitals, private practices, and academic settings; and finally, the failure to develop strategies to remove oneself from questionable investments and business associations. Self-referrals occur when physicians refer to medical facilities in which they have financial interest. Multiple concerns related to self-referral, including conflict of interest and increased costs to the Medicare program, resulted in a ban on self-referral arrangements for clinical laboratory services under the Medicare program in 1989 known as Stark I. In 1993, the Stark I prohibition on self-referrals by physicians expanded to include 10 additional healthcare services known as designated health services or DHS. The 1993 expansion of Stark I was enacted in 1995 as Stark II. In 2007, CMS adopted Phase III of the regulations interpreting Stark II. Phase III made multiple changes and clarified many previous issues, and it becomes effective December 4, 2007. While it is mandatory to obtain expert legal advice and this manuscript in no way provides the extensive navigation required through the maze of Stark laws and other anti-kickback statutes, it is incumbent on interventionalists in all settings of practice to have appropriate knowledge of the Stark laws and exceptions and of the anti-kickback statute and safe harbors. Penalties for violating the Stark laws are severe, including fines of up to dollars 15,000 per service and the economic threat of exclusion from participation in federal healthcare programs, which may result in exclusion of any type of healthcare program and loss of privileges at hospitals and surgery centers. This manuscript reviews physician practices in general, physician payments, and self-referral patterns in particular, the evolution of the Stark law and regulations and its implications for physician practices. This article is not, and should not be, construed as legal advice or an opinion on specific situations.

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