Searching Content indexed under Food, Drugs, Healthcare, Life Sciences by Heather O'Shea ordered by Published Date Descending.
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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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
OIG Cautions Physicians To Consider Compensation Arrangements Carefully
The Department of Health and Human Services, Office of Inspector General recently released a fraud alert cautioning physicians who enter into medical directorships and other compensation arrangements.
United States
18 Jun 2015
Defining The Bounds Of The Public Disclosure Bar And The Scope Of "News Media"
On March 3, 2015, a court in the Southern District of Texas granted a defendant pharmaceutical company's motion for summary judgment on claims brought under the False Claims Act for alleged false claims...
United States
16 Apr 2015
2015 HHS OIG Work Plan Focuses On Payment Accuracy, Privacy Concerns, And Insurance Marketplaces
On October 31, 2014, the Department of Health and Human Services ("HHS"), Office of Inspector General ("OIG") published its Work Plan for Fiscal Year 2015 ("2015 Work Plan") to provide an annual summary of new and ongoing OIG audit activities related to HHS programs.
United States
20 Nov 2014
Time Running Out To File Comments On OIG Proposed Rulemaking That Gives OIG Limitless Time To Exclude Providers
Statutes of limitation serve an essential purpose in ensuring that claims are timely pursued before evidence becomes stale.
United States
1 Jul 2014
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