The Stage 2 Meaningful Use requirements proposed last week by CMS as part of the Medicare and Medicaid incentive programs to expand the use of Electronic Health Record (EHRs) maintain the same core and menu structure as the Stage 1 criteria. The proposed rule, however, gives providers an additional year, until 2014, to implement Stage 2 criteria ...
Decree-Law no. 50/2012, of 2 March is the most recent legislative measure on maritime insurance in Portugal. This legislation, that transposes into the Portuguese legal system from the Directive 2009/20/EC dated 23 April 2009 of the European Parliament and of the Council, regarding the insurance of ship owners for maritime claims (the «Directive»), has entered into force on last 3 March ...
Law no.11/2012 of 8 March establishes new rules for prescription and dispensing of medicines. Prescriptions for medicines must now include the International Nonproprietary Name (INN) of the active substance,its pharmaceutical form, the dosage, the presentation and the posology. The prescription may also include a trade name by brand or indication of the name of the holder of the marketing authorisation ...
After three days of historic oral arguments before the U.S. Supreme Court, the fate of the Affordable Care Act (ACA), the momentous 2010 health reform law, is uncertain, given robust questioning of the ability of Congress to force individuals to purchase health insurance ...
The U.S. Fourth Circuit Court of Appeals has reversed a $44 million judgment against Tuomey Hospital in Sumter, South Carolina that arose from Tuomey’s employment arrangements with physicians that allegedly violated the federal Stark Law.1 The Stark Law prohibits hospitals from submitting claims to Medicare for designated health services that were referred by physicians with whom the hospital has a financial relationship, unless the relationship fits within an exception ...
In Greek mythology, Prometheus stole fire from Zeus to give to mankind. It seems that Zeus is now reclaiming some of that fire in the guise of Mayo Collaborative Servs. v. Prometheus Labs., Inc., No. 10-1150 (U.S. Mar. 20, 2012), the Supreme Court’s latest decision addressing patent-eligible subject matter. But a practical analysis of Prometheus reveals strategies one can use in drafting patent claims to keep those claims burning ...
Three recent decisions bolster a generic manufacturer’s ability to challenge Orange Book listings and obtain ANDA approval through section viii “carve-outs.” In Caraco v. Novo Nordisk1 the U.S. Supreme Court unanimously held Caraco could use the Hatch-Waxman’s counterclaim provision to correct Novo’s overbroad use code. In AstraZeneca v. Apotex, the U.S ...
The notion of insurable interest is funa mental to insurance law as it is at the very heart of the validity of this contract. The lack of insurable interest leads to the nillity of the insurance policy and justifies the insurer's refusal to indemnify its insured1. In a decision rendered on March 2, 2012, the Court of Appeal upheld a judgment of the Superior Court2, where an insurer refused to indemnify the insured, raising its lack of interest in the property3 ...
New amendments to the Regulation on Health Conformity of Dietetic Products have entered into force on 28 May 2012. Here are some of the most significant changes that are prescribed by these amendments to the Regulation. As a reminder, this is a regulation that introduced the obligation of the registration of dietetic products (including supplements) in July 2010, and is a regulation that regulates the issues of labelling and the composition of these products in details ...
The provision of gifts and hospitality to public officials has recently been the subject of a number of news stories in the Serbian media, covering not only the official reports on the variety of protocol gifts received by the high ranking officials from the leaders of other countries, but also the alleged corruption affairs involving the potential bribing of various lower-level officials by companies and individuals seeking an unfair advantage in the market ...
On January 24, 2011 the Attorney General of the Federal Republic of Brazil signed a document restricting the powers of ANVISA (Brazil’s regulatorybody) in the examination of pharmaceutical applications, giving the rights to the Brazilian PTO to do so without any interference of ANVISA. The dispute between ANVISA and the Brazilian PTO in the examination of pharmaceutical applications had apparently been solved ...
The LA CAPITALE Ruling has been expected since 2009, when the Superior Court authorized a Class Action against an insureer who had unilateraly modified the Waiver of Premiums Clause in a group insurance contract in 2001 ...
In a unanimous decision rendered on June 22nd , the Supreme Court of Canada confirms the principles previously established by the Court of Appeal: Quebec’s Automobile Insurance Act1 (“Act”) must be given a large and liberal interpretation. In this case, the Court confirms that the mere use of a vehicle as a means of transportation will be sufficient for the Act to apply even if the vehicle is not the cause of the accident ...
The Securities Act [SA] allows the Autorité des marchés financiers [the “AMF”] to order investigations to ensure compliance with the SA and to repress contraventions which may be committed1. This is the context in which the Court of Appeal handed down a decision2 on June 22, 2012 going to the very heart of the role played by the AMF’s investigators and the scope of their powers during examinations conducted in connection with an investigation ...
The Federal Trade Commission’s increased focus on the antitrust implications of healthcare mergers and acquisitions has been widely publicized. While scrutiny has largely been directed toward hospital and health system transactions, a recent case in Nevada indicates that the FTC is now taking an interest in relatively small provider combinations in highly concentrated markets ...
On August 2, 2012, the Court of Appeal rendered a major decision on professional liability insurance1. As a result of this ruling, insureds and insurers alike should review the wording of such policies, especially gross fault exclusions and the definition of "professional activities". The ruling is also noteworthy for its treatment of apportionment of liability between the professional and the client ...
Managing General Agent (“MGA”) Agreements are unique and can be exceedingly complex. They often include detailed underwriting guidelines and strict limits on an MGA’s authority. After all, an MGA is authorized to bind an insurer on substantial risks often with little direct supervision by the insurer. While no two MGA Agreements are the same, all must incorporate certain required provisions. The NAIC has promulgated the Managing General Agents’ Act (NAIC Model No ...
Parallel debt is a legal concept applied in international financing transactions that involve multiple lenders. In order to simplify the administration of security (for example, to avoid the need for retaking or reregistering security for a fluctuating group of lenders) and to reduce costs, the banks select a single entity from among them to administer the security ...
Insurance allows someone who suffers a loss or accident to be compensated for the effects of their misfortune. It lets you protect yourself against everyday risks to your health, home, business and financial situation. Concepts of insurance have been extended beyond the coverage of tangible assets. Now the risk of losses due to sudden changes in currency exchange rates, political disturbance, negligence and liability for the damages can also be covered ...
On September 17, 2012, the Department of Health and Human Services (“HHS”) announced a $1.5 million settlement with the Massachusetts Eye and Ear Infirmary and Massachusetts Eye and Ear Associates Inc. (“MEEI”) for potential violations of the HIPAA Security Rule ...
Currently a large part of politicians, economists and lawyers are working hard to ensure that a recent Lithuania’s bank bankruptcy story would not repeat itself. Sometimes people still associate the term “bank” with instability, possibility to lose something or lack of transparent governing. Maybe this is the reason why there are no biobanks in Lithuanian which are widespread in the EU and other countries of the world ...
Following the important judgment rendered by the Court of Appeal on August 2, 20121, the Court has ruled once again, on September 27, 20122, on the exclusions for gross fault with respect to professional liability insurance. In addition, the decision confirmed, as provided in the Civil Code, that an intentional fault is never covered ...
Following the important judgment rendered by the Court of Appeal on August 2, 20121, the Court has ruled once again, on September 27, 20122, on the exclusions for gross fault with respect to professional liability insurance. In addition, the decision confirmed, as provided in the Civil Code, that an intentional fault is never covered. THE FACTS After their mother’s death, Pierre Audet and Marie Audet ("the Audet") hired Jacques-André Thibault ("Thibault") to manage their assets ...
On 15 October 2012, the Federal Government announced the appointment of an expert panel to review pharmaceutical patents in Australia (Review). The Review will focus particularly on the extension of term provisions in Chapter 6, Part 3 of the Patents Act 1990 (Cth). Those provisions currently allow the extension of pharmaceutical patents up to five years beyond their standard 20-year term ...
The General Medical Council has issued definitive guidance on doctors' duties when they fear a child in their care is suffering from abuse. The GMC's 2012 Guidance on Child Protection came into effect on 3 September 2012 after a two-year working group - chaired by a senior family court Judge, the Right Honourable Lord Justice Thorpe - listened to evidence given by child protection experts ...
