Articles Posted in Stark and Anti-Kickback

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 brief background, the SDP provides […]

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 of background, the Stark Law […]

“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 Stark proposed rule is an […]

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 primary goals of this update […]

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 Stark Law addresses the concern […]

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 centers around a retail pharmacy […]

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 go into effect on January 6, […]

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 grown tremendously in recent years, […]

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 (which prohibits physicians from referring […]

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 false claims to a government […]

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