Rob DeConti on the Latest Guidance and Insights from the OIG at HHS
Susan Roberts on Creating a Compliance Program Book
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Although most health care lawyers and compliance officers who review and analyze physician compensation understand that fair market value (FMV) is important, the nuances around FMV are sometimes missed....more
The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more
Medical Supplier Agrees to Pay $29 Million for FCA Violations - Earlier this month, the US Department of Justice (DOJ) and medical supplier Lincare Holdings Inc. reached an agreement to settle claims that Lincare violated...more
Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more
For a healthcare or life sciences company settling a government enforcement action, the prospect of being subject to an independent monitor, independent review organization (IRO), or other government-mandated compliance...more
On March 2, 2023 and March 3, 2023, in a pair of speeches by Deputy Attorney General (DAG) Lisa Monaco and Criminal Division Assistant Attorney General (AAG) Kenneth Polite, the U.S. Department of Justice (DOJ) announced...more
In recent years, there have been only a handful of corporate integrity agreements (“CIAs”) and integrity agreements (“IAs”) that have included a “conditional exclusion release” of the Office of the Inspector General for the...more
The Office of Inspector General of the U.S. Department of the Health and Human Services (OIG) recently changed the language describing a compliance officer’s role in relation to other responsibilities he or she may have...more
The Department of Justice (“DOJ”) recently announced two settlement agreements, both involving durable medical equipment (“DME”) companies, following allegations that the companies had violated the Anti-Kickback...more
Physician Partners of America Agrees To Pay $24.5 Million To Resolve False Claims Act Allegations - Physician Partners of America LLC (PPOA), its founder, and its former chief medical officer agreed to pay $24.5 million to...more
The U.S. Department of Justice (DOJ) announced that Flower Mound Hospital Partners LLC, a partially physician-owned hospital in Flower Mound, Texas, agreed to pay $18.2 million to settle its alleged violations of the False...more
For the first time since April 2013, the Department of Health and Human Services’ Office of Inspector General (OIG) revised the Provider Self-Disclosure Protocol (SDP) on November 8, 2021. The SDP allows providers and other...more
On November 8, 2021, the Department of Health & Human Services (HHS) Office of Inspector General (OIG) released a revised and renamed Provider Self-Disclosure Protocol: the OIG “Health Care Fraud Self-Disclosure” protocol...more
Report on Medicare Compliance 30, no. 32 (September 13, 2021) - John Peter Smith (JPS) Hospital in Fort Worth, Texas, agreed to pay $3.3 million to settle false claims allegations in a case with a hot risk area, a...more
On November 16, 2020, the Office of the Inspector General of the Department of Health and Human Services (HHS-OIG) issued a Special Fraud Alert regarding the inherent fraud and abuse risks associated with...more
Exploring the Implications of HHS-OIG’s Special Fraud Alert and Groundbreaking Novartis CIA Requirements on Compliance Program Policies and Controls that Govern Speaker Programs - A Special Fraud Alert issued by the U.S....more
Novartis Pharmaceuticals Corporation (Novartis) recently entered into a civil settlement agreement with the Department of Justice (DOJ) to resolve allegations that the company paid health care practitioners (HCPs) who spoke...more
Corporate integrity agreements (CIAs) continued to be an important tool for the Office of Inspector General, U.S. Department of Health and Human Services (HHS-OIG) in 2019. Notably, pharmaceutical and device manufacturers saw...more
Report on Medicare Compliance 28, no. 44 (December 16, 2019) - One way to find out whether compliance and integrity have seeped into the bones of an organization is asking people who would know. There may be a compliance...more
Over the last two years, much of the healthcare world has been watching the government’s prosecution of Insys Therapeutics for its sales and marketing practices related to its Subsys spray. Subsys is powerful and highly...more
As reflected in recent remarks by Deputy Attorney General Rod Rosenstein, the United States Department of Justice (DOJ) is “reinforcing its relationship with good corporate citizens” by coordinating with, and considering, the...more
In 2018, even more than in recent years, federal lawmakers and regulators continued the push toward modernizing the existing legal framework to support and encourage digital health adoption in the context of care coordination...more
The Situation: The total number of Corporate Integrity Agreements ("CIAs") between the Office of Inspector General ("OIG") and health care entities has been decreasing, and the OIG recently decided it would spotlight entities...more
The Department of Justice (DOJ) recently announced that Montana’s Kalispell Regional Healthcare System (KRH) and six subsidiaries and related entities agreed to pay $24 million to resolve allegations that they violated the...more
On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more