12 Business and Legal Considerations for Successfully Developing a “Hybrid” Office-Based Laboratory—Ambulatory Surgery Center

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In recent years, changes to Centers for Medicare and Medicaid Services’ (CMS) reimbursement policies for outpatient interventional procedures has both expanded the scope of surgical services that may safely be performed in outpatient non-hospital based settings (such as a Medicare-certified ambulatory surgery centers (ASC) and officebased laboratories), while simultaneously adjusting reimbursement in these settings to align with CMS “site-neutral” payment policies that reimburse providers the same amount for the same clinical services regardless of the setting in which the services are provided. The transition to site neutrality has been a slow and uneven process as CMS considers the appropriateness of select reimbursement adjustments for services, and as providers push back against reimbursement cuts intended to achieve site-neutrality.

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