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Searching Content indexed under Food, Drugs, Healthcare, Life Sciences by T. Reed Stephens ordered by Published Date Descending.
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1
First Of Its Kind: Drug Wholesaler Accepts DPA And Two Executives Face Criminal Charges In SDNY For Illegal Distribution Of Opioids
On April 23, 2019, the US Department of Justice (DOJ) announced it has entered into a deferred prosecution agreement with Rochester Drug Co-Operative, Inc. (RDC),
United States
22 May 2019
2
Health Care Enforcement Quarterly Roundup | Q4 2018
This latest installment of the Health Care Enforcement Quarterly Roundup reflects on trends that persisted in 2018 and those emerging trends that will carry us into 2019 and beyond.
United States
8 Feb 2019
3
Health Care Enforcement Quarterly Roundup | Q3 | September 2018
In the latest installment of Health Care Enforcement Quarterly Roundup, we examine key enforcement trends in the health care industry that we have observed over the past few months. In this issue,
United States
9 Oct 2018
4
Health Care Enforcement Quarterly Roundup Q3 | September 2018
In the latest installment of Health Care Enforcement Quarterly Roundup, we examine key enforcement trends in the health care industry that we have observed over the past few months.
United States
9 Oct 2018
5
Health Care Enforcement Quarterly Roundup (October 2018)
In the latest installment of Health Care Enforcement Quarterly Roundup, we examine key enforcement trends in the health care industry ...
United States
9 Oct 2018
6
Health Care Enforcement Quarterly Roundup - July 2018
Over the past 18 months, we have closely monitored the Trump administration's approach to health care enforcement issues, with a particular focus on whether prosecution of the False Claims Act (FCA) ...
United States
25 Apr 2018
7
DOJ Continues Action Against Medicare Advantage Plans, Showing Increased Focus On Intersection Of The FCA And Managed Care
Last year, DOJ intervened in United States ex rel. Poehling v. UnitedHealth Group., Inc. (C.D. Cal.). In this case, DOJ alleged FCA violations relating to Medicare Advantage ....
United States
23 Apr 2018
8
Private Equity Sponsor Named As FCA Defendant
DOJ also made news in February 2018 when it named a private equity firm as a co-defendant in United States ex rel. Medrano and Lopez v. Diabetic Care Rx, LLC d/b/a Patient Care America, e ...
United States
23 Apr 2018
9
DOJ Leadership Reaffirms Expanded Enforcement Of The FCA To Combat Opioid Epidemic
In his March 2018 confirmation hearing, President Trump's nominee to head DOJ's Civil Division, Joseph "Jody" Hunt, signaled that DOJ would continue with its aggressive enforcement of the FCA.
United States
23 Apr 2018
10
DOJ Announces Significant Shift Towards Affirmative Dismissal Of "Frivolous" Qui Tam Complaints: A New Exit Strategy For Defendants?
Attendees at the Health Care Compliance Association's Health Care Enforcement Compliance Institute are reporting that, Michael Granston, Director, Civil Frauds, Commercial Litigation Branch...
United States
17 Nov 2017
11
A Hospital's Deserving Stark And AKS Victory—But At What Cost?
Bingham is a serial relator who practices as a certified real estate appraiser in Tennessee and was unaffiliated with BayCare.
United States
12 Jun 2017
12
DOJ's "Yates Memorandum" Calls For Increased Focus On Individuals In Investigating Allegations Of Both Criminal And Civil Corporate Wrongdoing
On September 9, 2015, the U.S. Department of Justice released a memorandum to prosecutors nationwide regarding "Individual Accountability for Corporate Wrongdoing," authored by Deputy Attorney General Sally Q. Yates.
United States
28 Sep 2015
13
Huge Stark Law Hospital Settlements And Physician Culpability - The New Normal Post-Tuomey?
After the federal government's victory against Tuomey Hospital, we have seen an increasing number of large False Claims Act (FCA) settlements with hospitals involving Stark Law allegations.
United States
28 Sep 2015
14
Can Satisfying A Regulatory Requirement Now Equate To Providing Illegal Remuneration?
The disposal of weak cases by the government through the intervention decision making process has always been a critical safety valve for non-culpable defendants.
United States
15 Sep 2015
15
Amarin Ruling Solidifies Off-Label Marketing Options But Raises Questions About False Claims Act Enforcement Action
While the Amarin decision is welcome news for the industry, drug manufacturers must still take care to analyze promotional statements to ensure that the content can be successfully defended as "truthful" and "non-misleading" speech.
United States
20 Aug 2015
16
Tuomey's Appeal Of $237M False Claims Act Judgment Denied By The Fourth Circuit
Judge Wynn's analysis in this case is timely, as Stark Law cases are on the rise, and questions regarding the proportionality and fairness of Stark Law liability grow ever more pressing.
United States
14 Jul 2015
17
Fourth Circuit Upholds Judgment Of Over $237 Million Against Tuomey Healthcare System
On July 2, 2015, the U.S. Court of Appeals for the Fourth Circuit affirmed the U.S. District Court for the District of South Carolina's judgment of $237,454.195 in damages and penalties against Tuomey Healthcare System.
United States
8 Jul 2015
18
Use Of Statistical Sampling To Establish Damages In FCA Cases Still Controversial
The defendants responded that, among other things, the court's ratification of Relator's statistical sampling methodology was premature.
United States
20 May 2015
19
FDA Issues Draft Guidance, Requests Public Comments On Communication Of Off-Label Information
The U.S. Food and Drug Administration is evaluating its policies regarding the communication of off-label information for drugs, biologics and devices, with the issuance of a draft guidance and the opening of a docket for public comments.
United States
10 Jan 2012
20
Qualifying Health-Sciences Companies Should Act Quickly to Secure Available Tax Credits and Grants for Investments in Therapeutic Discovery Projects
The Patient Protection and Affordable Care Act of 2010 has added a section to the Internal Revenue Code, providing a 50 percent tax credit for eligible taxpayers who invest in qualified therapeutic discovery projects in 2009 and 2010.
United States
9 Jun 2010
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