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Searching Content by Heather O'Shea ordered by Published Date Descending.
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1
D.C. Circuit Rejects Novel Theory Of Reverse False Claims Liability For Reporting Violations
The prospect of a substantial bounty often motivates enterprising relators to assert novel theories of recovery under the FCA—including, increasingly, under the FCA's reverse false claims provision, ...
United States
24 Jul 2019
2
False Claims Act Update: DOJ Releases Guidelines For Cooperation Credit And Reduced Penalties
The U.S. Department of Justice seeks to use the potential for a reduced penalty amount and damages to encourage self-disclosure of misconduct and cooperation during FCA investigations.
United States
16 May 2019
3
Department Of Justice Moves To Dismiss FCA Cases Involving Patient Support Services
This week, the Department of Justice ("DOJ") moved to dismiss 10 False Claims Act ("FCA") cases around the country that challenged patient support services in the pharmaceutical industry.
United States
4 Jan 2019
4
Public Branding, The OIG's New Method Of Punishing Health Care Entities?
The total number of CIAs between the OIG and health care entities has been decreasing, and the OIG recently decided it would spotlight entities that decline to participate in these agreements.
United States
19 Dec 2018
5
Sunshine Act Reporting Requirements Expanded To Physician Assistants And Advance Practice Nurses
A bill recently signed into law expands the reporting requirements under the Physician Payments Sunshine Act
United States
7 Nov 2018
6
D.C. District Court Vacates 60-Day Medicare Advantage Overpayment Rule
Her opinion vacates, retroactively to its inception, the 2014 overpayment rule and results in a clear win for MA organizations.
United States
7 Nov 2018
7
Pharmaceutical Company Agrees To $625 Million False Claims Act Settlement
The Department of Justice ("DOJ") recently announced that it agreed with AmerisourceBergen Corporation ("ABC") and several of its subsidiaries to resolve a False Claims Act ("FCA") case for $625 million.
United States
18 Oct 2018
8
Ninth Circuit Clarifies Import Of Escobar In False Claims Act Litigation
Courts have disagreed over whether Universal Health Services, Inc. v. Escobar, 136 S. Ct. 1989 (2016), announced a mandatory test for implied certification liability under the False Claims Act.
United States
25 Sep 2018
9
DOJ Pursues PE Firm Based On Portfolio Company's Alleged Payment Of Kickbacks
The Situation: In what may indicate a sea change in terms of who the Department of Justice ("DOJ") is willing to pursue in False Claims Act cases, a private equity firm has been named as a co-defendant in a False Claims Act complaint, along with one of its portfolio companies.
United States
2 Mar 2018
10
2017 Statistics Again Show Massive Recoveries In False Claims Act Cases
Newly released statistics illustrate that 2017 brought continued False Claims Act enforcement.
United States
1 Feb 2018
11
DOJ Should Dismiss Meritless False Claims Act Qui Tam Relator Claims
Despite recently acknowledging the significant burden imposed by frivolous False Claims Act claims and affirming its statutory grant of power to dismiss meritless claims brought by relators...
United States
1 Dec 2017
12
Court Overreaches In Requiring Medical Necessity Determination By Labs
On June 9, 2017, the U.S. District Court for the District of Columbia denied a motion to dismiss brought by a laboratory in U.S. ex rel. Groat v. Boston Heart Diagnostics Corp., 2017 WL 2533341.
United States
7 Jul 2017
13
False Claims Act: Circuit Court Questionably Construes Scienter Requirement
The Eleventh Circuit adopted an approach that could conflict with other courts' treatment of the FCA's intent requirement.
United States
27 Jun 2017
14
Court Creates Circuit Split Regarding The False Claims Act's Intent Requirement
The U.S. Court of Appeals for the Eleventh Circuit held that the False Claims Act's intent requirement can be met even if the underlying regulation that the defendant allegedly violated is ambiguous.
United States
20 Jun 2017
15
What Impact Will The New Trump Administration Have On State Attorney General Activity?
These "rollbacks" are seen as openings where state attorneys general can exert their own agenda to investigate, litigate, and regulate businesses.
United States
11 Jan 2017
16
DOJ Issues Rule Implementing Bipartisan Budget Act And Doubling FCA Civil Penalties
On June 29, 2016, the Department of Justice issued an interim rule—the Civil Monetary Penalties Inflation Adjustment, 81 Fed. Reg. 42,491 (June 30, 2016)—that will nearly double civil penalties for False Claims Act violations.
United States
12 Jul 2016
17
Illinois Creates Health Care Fraud Elimination Task Force
On April 5, 2016, Illinois Governor Bruce Rauner signed Executive Order 16-05, creating a new Health Care Fraud Elimination Task Force to address fraud, abuse, and waste in the state's health care programs.
United States
14 Apr 2016
18
美国阿玛林公司与美国食品药品管理局达成药品标示外推广的和解协议
On March 8, 2016, Amarin Pharma, Inc. reached a noteworthy settlement in its lawsuit against the U.S. Food and Drug Administration ("FDA") to protect its First Amendment right to promote the drug Vascepa for nonapproved, off-label uses.
United States
14 Apr 2016
19
Amarin And FDA Agree To Landmark Settlement On Off-Label Promotion
The FDA approved Vascepa (icosapent ethyl) capsules to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
United States
17 Mar 2016
20
HHS Proposes Revisions To The Common Rule For Protection Of Human Research Subjects
The proposed revisions are intended to promote protections for human subjects while also reducing the administrative burdens and delays for investigators that no longer enhance such protections.
United States
9 Sep 2015
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