Category: Stark Law

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...

CMS Stark Law Self Disclosure – New Form and Process for Self Disclosing Stark Law Violations

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The Centers for Medicare and Medicaid Services (CMS) has issued new forms and procedures for provider self-disclosure of Stark Law violations. The new material is intended to streamline the process that permits providers to self-disclose Stark Law violations.  The process is applicable to violat...

Remuneration Under the Stark Law I Stark Regulations Definition

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Remuneration Defined Under the Stark Law Regulations Remuneration means any payment or other benefit made directly or indirectly, overtly or covertly, in cash or in kind, except that the following are not considered remuneration for purposes of this section: (1) The forgiveness of amounts owed fo...

Designated Health Services Definition I Stark Law DHS Defined

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Definition of Designated Health Services under the Stark Law Regulations Designated health services (DHS) means any of the following services (other than those provided as emergency physician services furnished outside of the U.S.), as they are defined in this section: (1)(i) Clinical laboratory ...

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...

Definition of Remuneration Under the Federal Stark Law

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Remuneration Under the Stark Law Under the Stark Law, “remuneration” is defined broadly to include any payment or other benefit provided directly or indirectly, whether overtly or covertly, and whether in cash or in kind. This comprehensive definition is intentionally expansive to capture a wide ...

Medical Director Agreement Payments May Be Source of Stark Law Compliance Concerns

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MEDICAL DIRECTOR PAYMENTS AS STARK LAW VIOLATIONS The relatively recent case serves as a reminder of the potential exposure to Stark Law liability arising from payments to medical directors.  Let me immediately clarify that not all payments to directors who perform legitimate services that are a...

Special Rules on Compensation Stark Law

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Stark Regulations Special Rules On Compensation (d) Special rules on compensation. The following special rules apply only to compensation under section 1877 of the Act and subpart J of this part: (1) Compensation is considered “set in advance” if the aggregate compensation, a time-based or per-un...

Stark Law Regulations – Definition of Financial Arrangment

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Stark Law Definition of Financial Relationship Under Stark Regulations Sec. 411.354 Financial relationship, compensation, and ownership or investment interest. (a) Financial relationships. (1) Financial relationship means– (i) A direct or indirect ownership or investment interest (as defined in p...

Fair Market Value and Physician Compensation – Stark Law

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Fair Market Value Stark Law Regulatory Definition A number of areas of the Stark Law, Stark Regulations and comments to proposed and final rules discuss the concept of fair market value in connection with physician compensation.  I thought it might be useful to post some of the statutory and reg...

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...