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Sweeping changes to the federal anti-self-referral rules, approved more than a year ago, will take effect Oct. 1, potentially causing many physician-hospital arrangements to fall out of compliance if doctors are not prepared. Being unaware of the Stark law revisions or the structure of a particular deal will not excuse physicians from liability, legal experts say.

"What the changes did was make it much more difficult for physicians and other entities providing designated health services, primarily hospitals, to do joint ventures around hospital services," said Boston attorney Lawrence W. Vernaglia, co-chair of Foley & Lardner LLP's national health care payments, fraud and abuse, and compliance work group. "Stark is a strict-liability statute. So even if you have the most innocent of intentions, you are still subject to the grossest of penalties, as if you meant to violate the law."

The Stark law generally prohibits physicians from referring patients to entities in which they have a financial stake, with certain exceptions. The Centers for Medicare & Medicaid Services in an August 2008 final rule instituted broad revisions to the Medicare hospital inpatient prospective payment system that will restrict: