Searching Content indexed under Healthcare by Ropes & Gray LLP's Government Enforcement/White Collar Crime Practice ordered by Published Date Descending.
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MedPAC Takes Anti-POD Stance In Report To Congress, Echoing An Increasingly Uniform Consensus
On June 15, 2017, the Medicare Payment Advisory Commission, a non-partisan group that advises Congress on Medicare policy, released its annual Report to the Congress on Medicare and the Health Care Delivery System.
United States
26 Jun 2017
Managing Sanctions And Export Control Risks In The Health Care Industry
Over the past 15 years, pharmaceutical manufacturers, medical device companies, and other participants in the health care industry have been regular targets of FCPA enforcement actions brought by the U.S. government.
United States
15 May 2017
A Judicial Reinterpretation of the Brazilian Constitution's Right to Health Care
In recent years, there has been a spike in right-to-health litigation in Brazil wherein citizens seek court orders mandating that certain medications be dispensed through the public health system (Sistema Único de Saúde—"SUS").
31 Mar 2017
FDA Issues Three Key Documents Relating To Medical Product Manufacturer Communications
These documents represent a final attempt by the outgoing Administration to impact the agency's regulatory approach going forward.
United States
2 Feb 2017
European Health Care Compliance Challenges (And Solutions)
Future alerts will address these topics in greater detail.
European Union
20 Oct 2016
Donations And Grants In China: Compliance Controls Beyond T&E
Additionally, it may be worthwhile to understand the level of compliance controls employed by the intermediary to assess third-party compliance risks.
30 Sep 2016
FDA Announces Public Hearing On Manufacturer Communications Regarding Off-Label Uses
On August 31, 2016, FDA announced that it will hold a two-day public hearing on November 9 and 10, 2016 to obtain input on issues related to manufacturer communications regarding drugs and medical devices.
United States
7 Sep 2016
Supreme Court Endorses Implied Certification Theory Under False Claims Act —"At Least In Some Circumstances"
On June 16, 2016, the Supreme Court of the United States issued a unanimous opinion addressing the scope and reach of the False Claims Act ("FCA").
United States
23 Jun 2016
Medicare, Medicaid, And Enforcement Implications Of The 21st Century Cures Act Recently Passed By The House
The bill aims to bring new drugs to market faster by encouraging medical innovation, and grants additional funding to the NIH and Food and Drug Administration.
United States
24 Jul 2015
U.S. District Court Issues False Claims Act Judgment For Defendants In Case Challenging Competitive Bidding For DME Contract
After a fourteen-day bench trial, a Mississippi federal court in United States ex rel. Jamison v. McKesson Corp., et al., Civ. A. No. 2:08-cv-214-SA-JMV (N.D. Miss. Sept. 28, 2012), rendered a complete verdict for the defense, holding that in this federal False Claims Act case based on the Anti-Kickback Statute ("AKS") , the United States had failed to carry its burden to prove that illegal remuneration had been offered or accepted, or that any defendant had acted with the scienter required by t
United States
2 Nov 2012
D.C. Circuit Confirms Broader Applicability Of Net Loss Approach To FCA Damages Calculations
Last week, the D.C. Circuit held in "United States of America, ex rel. Davis v. District of Columbia", that in suits under the False Claims Act ("FCA") alleging false claims for Medicaid reimbursement, the calculation of damages must take into account the value of the medical services actually received.
United States
9 Jun 2012
First Circuit’s Oral Argument In "Rost" Revisits Prior Case Law Expanding False Claims Act Liability
On May 8, 2012, the United States Court of Appeals for the First Circuit heard oral arguments in "United States ex rel. Rost v. Pfizer, Inc." (10-2215).
United States
23 May 2012
The 60 Day Rule: CMS Issues Proposed Rule On Reporting & Return Of Overpayments
The February 16, 2012 Federal Register published a proposed rule from the Centers for Medicare & Medicaid Services ("CMS") that attempts to clarify providers’ and suppliers’ obligation under Section 6402 of the Patient Protection and Affordable Care Act of 2010 ("ACA") to report and return Medicare overpayments within sixty days of their identification.
United States
22 Feb 2012
The OIG Backs Off Intended Exclusion Of Forest Laboratories’ CEO
On August 5, 2011, the Office of the Inspector General, U.S. Department of Health and Human Services (the "OIG"), notified Howard Solomon, the CEO of Forest Laboratories, that the OIG would take no action against him under the permissive exclusion authority accorded the OIG by Section 1128(b)(15) of the Social Security Act ("SSA").
United States
16 Aug 2011
Sorrell v. IMS Health Inc. — Supreme Court Strikes Down Law Restricting Pharmaceutical Manufacturers’ Speech
On Thursday, the Supreme Court issued its decision in Sorrell v. IMS Health Inc., a case testing the constitutional limits of governmental restrictions on the speech of pharmaceutical manufacturers. By a vote of 6-3, the Court held that the law at issue — a Vermont statute that prohibits pharmaceutical manufacturers from obtaining or using "prescriber-identifiable information" collected from pharmacists for the purposes of "marketing or promoting a prescription drug" — is a "speaker- and content
United States
30 Jun 2011
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