Medical Device Legal News with Sam Bernstein: Episode 10
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Investment Management Roundtable Discussion – Regulatory and Enforcement Update
FCPA Compliance and Ethics Report-Episode 131, The FCPA Professor Takes a Look Back at 2014
The United States Environmental Protection Agency (“EPA”) and Los Robles Hospital Medical Center (“ Los Robles”) entered into a March 27th Expedited Settlement Agreement (“ESA”) addressing an alleged violation of the Federal...more
Community Health Network (CHN) in Indiana has agreed to pay $345 million to settle false claims allegations that it paid over-the-top salaries to hundreds of physicians and rewarded them for their referrals in violation of...more
We previously discussed the requirements of the Hospital Price Transparency Rule (“Rule”) on health care providers and health plans, as well as CMS’s proposal to increase penalties for a hospital’s failure to comply with the...more
By letter dated April 13, 2021 (Letter), the Democrat and Republican leadership of the House Committee on Energy and Commerce and its Subcommittee on Health, wrote United States Health and Human Services Secretary, Xavier...more
Will HHS’ approach for imposing penalties in the aftermath of a data breach become a little clearer in 2021? This is a distinct possibility in the wake of a Fifth Circuit decision vacating penalties against MD Anderson Cancer...more
Report on Patient Privacy 19, no. 12 (December 2019) - Sentara Hospitals, a nonprofit group of 12 medical centers in Virginia and North Carolina, will implement a fairly minimal two-year corrective action plan (CAP) and...more
On November 5, 2019, the U.S. Department of Health and Human Services, Office for Civil Rights (“HHS”) announced a $3,000,000 settlement with the University of Rochester Medical Center (“URMC”) for violations of the Health...more
On October 23, 2019, the Office for Civil Rights (OCR) at HHS announced the imposition of a $2,154,000 civil monetary penalty against a Florida hospital system (Hospital System) for alleged violations of the HIPAA Security...more
Report on Medicare Compliance 28, no. 38 (Oct. 28, 2019) - - Doctors Hospital of Augusta in Georgia agreed to pay $180,000 in a civil monetary penalty settlement over alleged violations of the Emergency Medical Treatment...more
DOJ News & Litigation Updates - ITT Cannon to Pay $11 Million to Settle False Claims Allegations - ITT Cannon (ITT), a division of ITT Inc., has agreed to pay $11 million to settle whistleblower claims that it supplied...more
At both the state and federal level, antitrust enforcement agencies continue to pursue successful challenges to physician practice transactions. This article summarizes two recent enforcement actions, as well as a new state...more
Data privacy and security legislation and enforcement saw significant activity in 2018 and early 2019. McDermott’s 2018 Digital Health Year in Review: Focus on Data report – the first in a four-part series – highlights...more
Two recent announcements by the Health Resources and Services Administration (HRSA) highlight the agency's plans for increased oversight in the next year of drug manufacturers under the 340B drug pricing program and...more
In this episode, Mark Rush and John Lawrence discuss the federal government’s expectations related to health care organizations conducting internal investigations and demonstrating a commitment to compliance. The episode also...more
Healthcare Management Associates (HMA) settled criminal and civil charges with the Justice Department for illegal fraud and kickback schemes. HMA billed federal government healthcare programs for inpatient services that...more
On May 16, 2018, the U.S. Attorney’s Office for the Southern District of Georgia announced that it had entered into the “largest hospital drug diversion civil penalty settlement in U.S. History” in the amount of $4.1 million...more
A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more
As the healthcare industry moves towards value-based purchasing, pay-for-performance, and other payment reform models, industry leaders have identified federal fraud and abuse laws as a barrier to full implementation of such...more
Yesterday, the Securities and Exchange Commission (SEC) announced a Foreign Corrupt Practices Act (FCPA) enforcement action against Bristol-Myers Squibb Company (BMS) for the actions of the company’s joint venture (JV) in...more
Are the Circuits A-Splitting? The Ninth Circuit Declines to Follow the Second Circuit's Insider Trading Decision in U.S. v. Newman - Why it matters: On July 6, 2015, the Ninth Circuit in U.S. v. Salman declined to...more
On November 7, 2014, the Antitrust Division of the U.S. Department of Justice (“DOJ”) reached a $5 million settlement with Flakeboard America Limited (“Flakeboard”), its foreign parents, and SierraPine to settle allegations...more
A new report issued October 16, 2014 by the Medicare Parts C & D Oversight and Enforcement Group (MOEG) reveals that civil monetary penalty (CMP) enforcement actions in these two programs more than tripled from 2012 to 2013....more