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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
Ukraine is a civil law country with the Constitution being a principal source of law. The main sources of civil and commercial law are acts promulgated by the legislative and executive branches of the state. International treaties ratified by Parliament become part of national law and prevail in a conflict with domestic law ...
The Centers for Medicare and Medicaid Services (CMS) on February 16, 2012 proposed rules1 implementing Section 6402(a) of the Affordable Care Act,2 requiring persons to report and return Medicare overpayments by the later of 60 days after an overpayment is identified or the date any corresponding cost report is due. Twice in the past, CMS had proposed rules requiring the return of Medicare overpayments, but did not finalize the regulations ...
The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services has begun the pilot phase of HIPAA privacy and security audits of health care providers, health insurers and health care clearinghouses (“covered entities”) to assess HIPAA compliance efforts. Up to 150 covered entities will be subject to the initial audits, to be conducted by KPMG, LLP, the OCR audit contractor ...
In its judgment of 19 January 2012 (case no. 08332/11), the Southern Central Administrative Court, decided that INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P. (the national authority for medicines and healthcare products), is obliged to issue a certificate of subsidisation of the price of a medicine even when the person requesting the issue of the certificate was not the person who applied for the subsidy ...
In connection with the recent changes in legislation in the field of health, the Federal Commission for protection against health risks ("Cofepris") has taken various actions against the sale, distribution and advertising of the so-called "miracle products," which are distributed without scientific evidence to demonstrate its therapeutic properties ...
Within the scope of the measures intended to promote the competition and liberalization of the business activities approved by the Council of Ministers on January 20, 2012, are included, among other things, special provisions concerning the performance of insurance services which introduce relevant amendmentsto the Legislative Decree No. 209 of September 7, 2005 (“Insurance Code”) ...
The honourable justice Louis-Paul Cullen of the Superior Court rendered a judgment on September 23, 2011 which dismissed a motion for authorization to exercise a class action instituted by Mr. Kerfalla Toure (hereinafter "Toure") against Brault & Martineau (hereinafter "B & M) . (1) In order for a class action to be authorized by the Superior Court, the Code of Civil Procedure sets out the four conditions which must be fulfilled ...
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The Centers for Medicare and Medicaid Services (CMS) has delayed the start date for data collection of payments made to physicians and teaching hospitals by drug and device manufacturers and group purchasing organizations (GPOs). Under the Physician Payment Sunshine Act (the “Sunshine Act”), such payments were to have been recorded beginning on January 1, 2012 ...
After being reviewed four times in three years, the Social Insurance Law of the People’s Republic of China (the “Social Insurance Law”) was finally adopted by the Standing Committee of the National People’s Congress of China on 28 October 2010. Its implementation rules (the “Implementation Rules”) were subsequently released by the Ministry of Human Resource and Social Security (“MHRSS”) on 29 June 2011. Both the Social Insurance Law and the Implementation Rules came into force on 1 July 2011 ...
The advent of social networks such as Myspace, Facebook, Diaspora, Photobucket, Twitter, You Tube, and others has brought significant changes to social relationships. In Quebec alone, more than 3,250,000 persons 1 have a profile on Facebook. In 2012, the use of social media intensified in Quebec; indeed, more than three quarters of netsurfers in Quebec visited at lease one social medium or contributed to its content ...
Imagine the effect on the privatization effort and the stability of the workers’ compensation insurance market in West Virginia if the standard workers’ compensation insurance policy1 was held to give an insured employer coverage for “deliberate intent” claims even though the insured employer did not inquire about, request, or pay for such coverage.2 Imagine the risk management implications and the effect on premiums for workers’ compensation insurers ...
Given the ongoing worldwide economic concerns and discussion of another recession, it is hard to believe that major provisions of the 2009 Stimulus Act impacting employers have yet to be fully implemented ...
Medicaid providers will be subject to new audits by Medicaid Recovery Audit Contractors (RACs), beginning in January 2012. These new audits will be in addition to existing audits being conducted by Medicare RACs, Medicaid Integrity Contractors (MICs) and Zone Program Integrity Contractors (ZPICs), among others.1 The Medicaid RAC audits, mandated as part of the 2010 Patient Protection and Affordable Care Act (the Health Reform Act), are expected to result in the recovery of $2 ...
Under final rules issued by the Centers for Medicare and Medicaid Services (CMS), Accountable Care Organizations (ACOs) will continue to face large start-up costs and uncertain savings, despite a decreased regulatory scheme and increased financial incentives ...
The Federal Circuit recently resolved two issues of first impression as to how patent reexamination proceedings affect related patent infringement litigation. These two cases, Marine Polymer1 and Bettcher Industries,2 are likely to have a significant impact on both litigation and reexamination-proceeding practices, as well as the strategic interplay between them ...
The Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) for the U.S. Department of Health & Human Services (HHS) have responded to the U.S. Senate’s request for information on physician-owned distributorships (PODs). Earlier this summer, a bi-partisan U.S. Senate committee asked CMS and the OIG to study the proliferation of PODs, citing a lack of regulatory guidance on how these arrangements square with existing federal law ...
