Category: Safe Harbor Regulations

Compliance Officer Authority and Resource Allocation

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The Department of Justice (DOJ) uses resource allocation as a key measure when evaluating the effectiveness of compliance programs. Allocating sufficient resources to the compliance function is foundational to any systematic compliance initiative and remains central as regulatory expectations evo...

Congress Enacts the Eliminating Kickbacks in Recovery Act of 2018

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Congress has enacted a new Anti-Kickback law, known as the Eliminating Kickbacks in Recovery Act of 2018 (EKRA). This legislation specifically targets arrangements involving recovery homes, clinical treatment facilities, and laboratories. Congressional Intent and Purpose The primary intent behind...

Apply the 60-Day Repayment Rule to Medicaid Overpayments

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Overview of Overpayment Reporting and Repayment The Affordable Care Act (ACA) imposes specific requirements on individuals and entities that receive overpayments from designated government health programs. Under the ACA, any person who has received an overpayment from programs such as Medicare Pa...

Telemedicine IT Donations and the Anti-kickback Statute OIG Opinion 18-03

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Overview of the OIG Advisory Opinion No. 18-03 The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 18-03 regarding an arrangement in which a federally qualified health center look-alike (the “Provider”) proposes to donate informati...

Fair Market Value Definition – Stark Law and Safe Harbor Regulations

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Stark Law Definition of Fair Market Value The term “fair market value” means the value in arm’s-length transactions, consistent with the general market value. ‘‘General market value’’ means the price that an asset would bring, as the result of bona fide bargaining between well-infor...

Ambulatory Surgery Center Structural and Valuation Issues

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ASC Regulatory and Structural Issues   A recent “advanced session” was provided by the American Health Lawyer’s Association covering several of the central legal issues that arise with respect to ASC ownership and structure.  The general issues covered in the webinar included:   1.A...

60 Day Repayment Rule and False Claims Act

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The 60-Day Repayment Rule and False Claims Act Providers Get Another Push Into Proactive Compliance The Patient and Program Protection Act (“PPACA”) added a number of additional tools to the government’s fraud fighting arsenal.  One of those tools is found in PPACA Section 6402 and require...