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The DFRR represents a significant change in CMS’s enforcement policy under the Stark law and increases the risk of scrutiny for both hospitals and physicians. It creates potentially new liabilities based on a hospital’s late submission of the DFRR and incomplete or inaccurate statements. If a hospital has not yet done so, it should examine all contracts or investment arrangements with physicians and evaluate its contract management systems to ensure compliance with Stark II requirements. If a hospital’s compliance plan does not already require collecting and reviewing this information through a legal audit of its physician agreements, then the hospital is strongly urged to do so in anticipation of CMS’s future adoption of an industry-wide mandatory disclosure program for hospitals.
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