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The Stark Act is implicated when a hospital or health system has a financial arrangement, which can be either an ownership or compensation arrangement, with a referring physician. The Stark Act has become a major weapon in the government’s arsenal with respect to Medicare fraud and abuse investigations and litigation. Violations of the Stark Act can produce draconian results as all of the Medicare reimbursement received from the applicable physician’s referrals during the period of non-compliance are possibly subject to repayment. Krieg DeVault has assisted many hospitals and health systems nationwide in developing, implementing, auditing, and monitoring financial arrangements with referring physicians to assist with Stark Act compliance. If a hospital has a financial arrangement that implicates this Stark Act, Krieg DeVault works with the hospital to conform with an applicable statutory or regulatory exception. In addition to assisting hospitals and health systems in being proactive with respect to Stark Act compliance, Krieg DeVault has assisted many hospitals and health systems in investigating financial arrangements for Stark Act compliance and making self disclosures, if Stark Act violations are discovered, through the Centers for Medicare & Medicaid Service’s Self Referral Disclosure Protocol.