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Articles Posted in Stark and Anti-Kickback

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OIG Updates the Self-Disclosure Protocol: Key Changes

On November 8, 2021, the Office of Inspector General (“OIG”) issued multiple updates to the Health Care Fraud Self-Disclosure Protocol (“SDP”), incorporating legal changes made since the previous SDP revision in 2013. The OIG’s updated SDP may be accessed here. Below is an overview of the updates. By way of…

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CMS Issues Blanket Waivers Under Stark Law

On March 30, 2020, the Centers for Medicare and Medicaid Services (CMS) announced that it will issue blanket waivers from sanctions imposed under section 1877 of the Social Security Act (SSA), often referred to as the Physician Self-Referral (Stark) Law, to healthcare providers responding to the COVID-19 pandemic. By way…

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Stark, AKS, and CMP Reforms on the Horizon with New HHS Proposed Rules

“We serve patients poorly when government regulations gather dust in the attic: they become even more stale and liable to wreak havoc throughout the health care system. Administrative costs are driving up the cost of health care in America – to the tune of hundreds of billions of dollars. The…

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Per CMS, Stark Law Modifications Around the Corner

In her Federation of American Hospitals’ 2019 Public Policy Conference speech, CMS Administrator Seema Verma indicated the Stark Law would be receiving a major overhaul sometime in 2019. This update, according to Verma, will “represent the most significant changes to the Stark Law since its [1989] inception.” One of the…

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CMS Seeks Additional Public Input on the Impact and Burden of the Stark Law

June 2018 – On June 19, 2018, the Centers for Medicare & Medicaid Services (“CMS”) issued a Request for Information (“RFI”) seeking public input on how to address any undue impact and burden of the physician self-referral law, 42 U.S.C. § 1395nn (the “Stark Law”). By way of background, the…

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OIG Gives Green Light to Pharmacy Discount Program Under CMP and AKS

In its recent Advisory Opinion No. 17-05, OIG stated that the Proposed Arrangement (“Arrangement”) would not violate the anti-kickback statute (“AKS”) nor would it prompt administrative sanctions under the Civil Monetary Penalties (“CMP”) provision of the Social Security Act, prohibiting inducements to beneficiaries. The Proposed Arrangement discussed in the Opinion…

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OIG Finalizes New Transportation Safe Harbor

On December 7, 2016, the Department of Health and Human Services Office of Inspector General (“OIG”) released a final rule (“Final Rule”) codifying new safe harbors to the Anti-Kickback Statute (“AKS”) and new exceptions to the beneficiary inducement provisions of the Civil Monetary Penalties law (“CMP”). The Final Rule will…

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U.S. Senate Committee Considering Reform of Stark Law

The U.S. Senate Committee on Finance released a whitepaper, which addresses proposed reforms of the Stark law (which prohibits physicians from referring Medicare beneficiaries to an entity in which they have a financial relationship for designated health services). The whitepaper asserts that support for reform of the Stark Law has…

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South Carolina Medical Center Owes $17 Million for Violations of Stark Law and False Claims Act

On July 28th, 2016, the Department of Justice released a report stating that the Lexington County Health Services District will pay $17 million for violations of the Physician Self-Referral Law (the Stark Law) and the False Claims Act. The Department alleged that Lexington Medical Center (“LMC”) violated the Stark Law…

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Spikes in Fraud Penalties under the False Claims Act and the Anti-Kickback Act

New rules published on June 30th, 2016 in the Federal Register could dramatically change the regulatory enforcement landscape for healthcare providers, with fraud penalties nearly doubling under the False Claims Act and the Anti-Kickback Act. The False Claims Act (which in pertinent part imposes penalties on healthcare providers for submitting…