Searching Content indexed under Healthcare by WilmerHale ordered by Published Date Descending.
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Common Physician Compensation Arrangement May Face Increased Scrutiny Under Stark Law
On September 17, 2019, the Third Circuit Court of Appeals issued a decision with potentially far-reaching implications for healthcare companies and providers facing allegations of violations of the Stark Law.
United States
25 Sep 2019
The Guide To Monitorships: The Healthcare Industry
For nearly 15 years, the Department of Justice (DOJ) has used independent monitors to address compliance issues with companies accused of violations of healthcare fraud statutes and regulations.
United States
8 Jul 2019
The Potential Impacts Of The Nagoya Protocol On Global Public Health Research
This is typically accomplished through negotiation of an ABS agreement between the party seeking access and the provider country.
United States
28 Jun 2019
False Claims Act: 2018 Year-In-Review
Federal False Claims Act recoveries in fiscal year 2018 amounted to $2.88 billion, down by roughly $600 million from the prior year and dropping below $3 billion for the first time in eight years.
United States
9 Jan 2019
False Claims Act: 2017 Year-In-Review
False Claims Act (FCA) recoveries topped $3.7 billion in fiscal year 2017, marking the eighth straight year of annual recoveries in excess of $3 billion.
United States
10 Jan 2018
Health Care Industry Cybersecurity Task Force Report Identifies Imperatives for Reform
Several media organizations this week published a pre-release copy of the report of the Health Care Industry Cybersecurity Task Force established pursuant to the Cybersecurity Act of 2015.
United States
8 May 2017
United States
29 Mar 2017
ConforMIS Inc. Secures $50M In Debt Financing From Oxford Finance
ConforMIS Inc. (CFMS)—a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture, and sell joint replacement implants that are...
United States
17 Jan 2017
False Claims Act: 2015 Year-in-Review
In 2015, the Justice Department (DOJ) continued to give high priority to False Claims Act (FCA) investigations, bringing in nearly $3.6 billion in settlements and judgments.
United States
14 Jan 2016
Inside Views: Learning From Ebola
In 1976, Yambuku village school headmaster Mabalo Lokela felt sick when he returned from a trip to northern Zaire near the Central African Republic border. He had a high fever, diarrhea, and bleeding.
United States
16 Jul 2015
Manufacturing Trouble: Is cGMP the Next Enforcement Frontier?
Current Good Manufacturing Practices (''cGMP'') may mark the next frontier in health care fraud enforcement.
United States
17 Oct 2014
Fourth Circuit Holds cGMP Violations Do Not Create False Claims Under Medicare And Medicaid
In the first appellate decision of its kind, the U.S. Court of Appeals for the Fourth Circuit held on Friday, February 21, that because compliance with the Food and Drug Administration's (FDA) Current Good Manufacturing Practices (cGMP) regulations is not a precondition for reimbursement under Medicare and Medicaid, violations of the cGMP regulations by themselves cannot form the basis for False Claims Act (FCA) claims under those programs.
United States
25 Feb 2014
China’s New Anti-Corruption Policies in the Health Care Industry
On December 26 and 25, 2013, respectively, China’s National Health and Family Planning Commission (NHFPC) promulgated two circulars, Circular [2013] No. 49 (Circular 49) and Circular [2013] No. 50 (Circular 50). Circular 49, issued by NHFPC's Chinese Medicine Management Bureau, provides comprehensive anti-corruption compliance requirements to be observed by hospitals and physicians, and Circular 50 establishes a "blacklist" system on pharmaceutical and medical device providers.
9 Jan 2014
More Breathing Room For Leadership Act Fund Recipients
On June 20, 2013, the U.S. Supreme Court upheld an injunction against enforcement of a provision of the United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003 (Leadership Act) that required any recipient of Leadership Act funds to adopt a policy explicitly opposing prostitution and to refrain from any speech — even privately funded — that the government deemed inconsistent with that policy.
United States
18 Sep 2013
FDA Issues Draft Guidance on Cybersecurity Considerations in Premarket Submissions for Medical Devices
The Food and Drug Administration recently issued draft guidance on the content of premarket submissions for management of cybersecurity in medical devices.
United States
26 Jun 2013
HHS Issues Final Omnibus HIPAA Rule
On January 17, 2013, the Department of Health and Human Services issued long-awaited final regulations.
United States
29 Jan 2013
Second Circuit Invalidates Misbranding Conspiracy Conviction On First Amendment Grounds
In a decision with potentially important implications for the pharmaceutical industry and for government regulation of commercial speech more generally, a divided Second Circuit panel yesterday vacated the conviction of a pharmaceutical sales representative for conspiracy to introduce a misbranded drug into interstate commerce in violation of the Food, Drug and Cosmetics Act (FDCA) on the ground that his conviction rested solely on speech promoting an FDA-approved prescription drug for off-label
United States
5 Dec 2012
The Exclusion Illusion - Fixing A Flawed Health Care Fraud Enforcement System
Judging by the headlines, the federal government’s efforts to prosecute fraud against the government in health care have been a great success.
United States
31 Oct 2012
Affordable Care Act Litigation: The Next Round
On June 28, 2012, the Supreme Court upheld the constitutionality of the individual mandate in the Patient Protection and Affordable Care Act ("ACA"), while invalidating the ACA’s conditioning of federal Medicaid funds on state acceptance of newly expanded Medicaid categories.
United States
19 Oct 2012
Pricing And Reimbursement For Pharmaceuticals In The European Union: European Commission Proposes Revised Transparency Directive
Today, the European Commission adopted its proposal for a new Directive relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of public health insurance systems ("Transparency Directive" or "Directive"), which is set to replace the current Transparency Directive 89/105/EEC in place since 1989.
European Union
14 Mar 2012
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