Medicare and Medicaid Programs; Hospital Conditions of Participation: Clarification of the Regulatory Flexibility Analysis for Patients' Rights

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On July 2, 1999, we published an interim final rule with comment period introducing a new Patients' Rights Condition of Participation (CoP) that hospitals must meet to be approved for, or to continue participation in, the Medicare and Medicaid programs. Several aspects of that interim final rule with comment period were challenged, including its regulatory flexibility analysis (RFA). As a result of this action, a Federal court, without enjoining continued enforcement of the rule, ordered the Secretary of the Department Health and Human Services (DHHS) to complete a compliant RFA to accompany the interim final rule with comment period. This document addresses the court's order.