On June 16, 2011, the Supreme Court issued an opinion in Smith v. Bayer allowing a plaintiff to pursue class certification in a state court action after a federal court had denied certification in a substantially similar case. The Court held that it was improper for the federal court to enjoin the state proceeding under the “relitigation exception” of the Anti-Injunction Act because the issues were not identical and the state court plaintiff was not a party to the federal lawsuit ...
A bipartisan U.S. Senate committee has asked both the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services to study the proliferation of physician owned distributorships (PODs), citing a lack of regulatory guidance on how these arrangements square with existing federal law ...
On May 25, 2011, the en banc Federal Circuit announced its decision in Therasense, Inc. v. Becton, Dickinson & Company regarding the appropriate standards for succeeding with an inequitable conduct defense ...
The Office for Civil Rights (OCR) of the Department of Health and Human Services today proposed an expansion of the rights of individuals to obtain reports from health providers and insurers about how their protected health information (PHI) is used.1 The draft regulations will require health providers and insurers (called “Covered Entities”) to provide more data faster and in a variety of formats as requested by individuals ...
The Centers for Medicare and Medicaid Services (CMS) announced the creation of so-called “Pioneer ACOs” on May 17 in an attempt to blunt heavy criticism over the draft regulations on Accountable Care Organizations (ACOs) issued on March 31, 2011 (the “Draft Regulations”).1 The Draft Regulations have been criticized due to their burdensome data collection requirements, large start-up costs, uncertain savings, possible losses and troublesome governance mandates ...
Southwest Health Alliance (“Southwest”), an independent practice association with approximately 900 member-physicians, has agreed to a proposed order recently entered by the Federal Trade Commission (“FTC”) settling charges that it engaged in anticompetitive conduct in its dealings with insurers and other payors for the provision of physician services (collectively, “insurers” or “payors”) ...
A former GlaxoSmithKline attorney, Lauren Stevens, was acquitted on May 10 of all criminal charges stemming from her response to an FDA investigation. The acquittal, ordered by U.S. District Judge Roger W. Titus, is a stunning defeat for the government’s anti-fraud enforcement measures. The judge also severely rebuked the government’s efforts in the matter, stating the case should never have been prosecuted. Had she been convicted, Stevens would have faced a prison term of up to 60 years ...
On April 18, 2011, the Centers for Medicare and Medicaid Services (CMS) began the attestation phase under its $27 billion Medicare EHR Incentive Program. Incentive payments for the meaningful use of electronic health records (EHR) will begin in May 2011 and will continue over the next several years. Eligible professionals (i.e ...
Accountable Care Organizations (ACOs) will face large start-up costs under proposed rules issued on March 31, 2011 by the Centers for Medicare and Medicaid Services (CMS), with an uncertain outlook for savings and even possible losses. An ACO is an organization of health care providers that agrees to be accountable for cost, quality and the overall care of Medicare beneficiaries who are assigned to it ...
How is health care in your jurisdiction organised? The basic principles of the organisation of the health-care system are governed by Act CLIV of 1997 (the Health-care System Act), more specifically by sections 141 et seq. Pursuant to section 141, the state is ultimately responsible for the state of health of the population, and for the creation of a system that protects, promotes and – if necessary – restores it ...
The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services has recently announced two significant enforcement actions against health care providers for violating the HIPAA Privacy Rule. In the first matter, Cignet Health Care of Prince George’s County, MD was fined $4.3 million for failure to provide patients with access to their health records and for failing to cooperate with the ensuing OCR investigation ...
HARMONIZATION OF CLINICAL RESEARCH CONTRACTS IN QUEBEC OLGA FARMAN and MARIE-ÈVE CLAVET [email protected] [email protected] Over the past few decades, a high-quality system of research and innovation has been built in the Province of Quebec. The contractual research conducted by university-affiliated health-care institutions in Quebec has become a fundamental scientific, economic and social activity ...
In Sweden, the directive has been implemented through amendments to the Medical Devices Act (1993:584), and through the regulation which the Medical Products Agency has issued in connection with this Act and the directive. The revised directive contains some clarifications but also some news ...
Hunton & Williams announced today the launch of its new website — the Hunton & Williams Health Care Reform Center, huntonhealthcarereform.com ...
Interest about the relevance of buyer power for competition has been growing in the last decades, as the markets of retail distribution were subject to a process of consolidation, if at different speed, in most European countries ...
The hospital has lost lengthy legal proceedings about the uninsured patients from the governments of the Netherlands Antilles and Curaçao. The governments are not obligated to write a “blank check”, as it were, for the costs Sehos had to incur for uninsured persons that cannot be recovered, according to judge Van Schendel yesterday ...
The U.S. Department of Health and Human Services, the U.S. Department of Labor and the U.S. Department of Treasury have released another set of interim final regulations (the “IFR”) regarding the coverage of preventive care without cost sharing. As with all guidance, the IFR cannot be considered in isolation ...
The answer is that they were both the subject of two recent decisions which shed further light on the ability to register three-dimensional shapes as trade marks. On the face of it, a three dimensional shape may be registered as a trade mark provided it meets the usual criteria (distinctive, non-descriptive, capable of distinguishing goods of one business from another etc) ...
The High Court has ruled that contractual interest will form part of any agreed liability cap, but that statutory interest arising from the exercise of the court's discretion will not. In Markerstudy Insurance Co Ltd and others v Endsleigh Insurance Services Ltd, the claimants alleged widespread breaches by the defendant of a number of agreements, causing the claimant to suffer loss of approximately £14m ...
Referring to Newsletter Issue No. 12 in relation to the Health Bill, the new Health Law No. 36 of 2009 was finally issued on 13 October 2009. Under the Health Law, mothers must breastfeed their babies exclusively from birth until 6 months old. It is expected that family members, the Government, Regional Governments and communities will support lactating mothers by providing time and space for them to breastfeed their babies in work places and public areas ...
Under the Tobacco acT (r.s.Q., c. t-0.01), employers mUst prohibit their employees from smoKing inside their establishments. howeVer, the act is mute on no smoKing oUtside, on the company’s land ...
by Bryan G. Scott and Elizabeth K. Strickland Few areas of law have proven more dynamic over the last few years than the interplay between state tort laws and the federal regulation of pharmaceutical drugs and medical devices ...
The Information Commissioner's Office (ICO) has launched the new Privacy Notices Code of Practice. It is the most recent step in the ICO's continuing battle to ensure consumers are kept informed about how and why their personal data will be processed. Months of ICO research has revealed that over half of consumers do not understand what they are signing up to when they fill in online and paper forms ...
The Bill requires online retailers to take 'all reasonable steps' to avoid selling age-restricted products to those underage. It also requires annual advice from government to retailers setting out what constitutes 'all reasonable steps' ...
Customs has changed, with immediate effect, the way in which they deal with goods suspected of infringing brand owners' intellectual property rights. The changes are bad news for brand owners who now have to initiate court proceedings each and every time they wish Customs to seize a consignment of infringing goods ...
