Hurricane Irene’s path along the Eastern Seaboard has affected millions of people and exposed businesses to property loss, business interruption, and supply network disruption. Those affected by Irene should immediately think about insurance coverage for their loss. Commercial Property Insurance In the event of a loss, a company should take steps to preserve coverage ...
Once their compound patents have expired many blockbuster drugs remain protected by secondary 'method of treatment' patents. The validity and enforceability of these secondary patents can be less certain in many jurisdictions. In Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd (No ...
The Florida Agency for Health Care Administration (“AHCA”) earlier this month fined Humana $3.4 million for failing to promptly report suspected cases of Medicaid fraud and abuse by others, as required by statute and Humana’s Medicaid HMO contract. Though many states have similar laws or regulations, this appears to be the first enforcement action of its kind in the nation ...
The aim of the recent freedom of information (FOI) reforms was to encourage a pro-disclosure culture, and to provide additional assistance and guidance to both the applicant and agencies in processing FOI requests. However, since the commencement of those reforms, maintaining the balance between the philosophy and the practical operation of the FOI Act has presented challenges for agencies in meeting their statutory FOI obligations ...
The Internal Revenue Service has proposed guidelines detailing how tax-exempt hospitals can conduct a Community Health Needs Assessment (CHNA), as required in the 2010 Patient Protection and Affordable Care Act (PPACA). Although this new requirement is not effective until taxable years commencing after March 23, 2012, the IRS issued its guidance now because hospitals may choose to start the process of conducting CHNAs and implement strategies in advance of the effective date ...
Texas health care providers, health insurers and health clearinghouses face new mandates and increased penalties over the use of electronic health records (EHR) as a result of HB300, which was passed in the 2011 Texas legislative session and signed into law by Governor Rick Perry. The Texas legislation expands privacy rights of patients beyond that contained in federal HIPAA legislation ...
On July 1, the Texas Supreme Court handed down an opinion that has the potential to impact any case where medical or health expenses are at issue. In the wake of the Court’s ruling, a plaintiff may not recover medical expenses for amounts that the plaintiff’s health providers bill but have no right to be paid. In addition, the Court held that such bills are inadmissible - including to show pain and suffering. Case Background and Issues Presented Haygood v ...
As you will be aware, 1 January 2012 is the go live date for OHS harmonisation. A new OHS Act, Regulation and Codes of Practice will commence in the Commonwealth and in each State and Territory at this time. The new package of OHS legislation will be based on model legislation, so will be substantially similar in each jurisdiction. For detailed information about the state of play in relation to OHS harmonisation, see our HR&IR Update of 22 June 2011 ...
Following the introduction of the Tertiary Education Quality and Standards Agency Bill 2011 (Bill) and the Tertiary Education Quality and Standards Agency (Consequential Amendments and Transitional Provisions) Bill 2011 (Transitional Bill) into the Commonwealth Parliament (as reported in our news alert of 23 March 2011), the Senate referred the Bill and the Transitional Bill to the Senate Education, Employment and Workplace Relations Legislation Committee (Commi
After more than three years of delays, studies and public consultations, the Canada Consumer Product Safety Act (the “Act”) came into force on June 20, 2011. The Act imposes new obligations on manufacturers, importers and sellers of consumer products and grants significant powers to Health Canada. It will impact this critical sector of our economy ...
During the 2011 legislative session that just ended, Texas Governor Rick Perry signed into law a bill that allows rural hospitals to employ physicians, known as the “corporate practice of medicine,” despite the state’s long-standing ban on such practices. This legislation, along with similar recent legislation, signals that Texas might eventually do away with its ban on corporate employment of physicians altogether ...
FIRE SAFETY ACTThe Fire Safety Act (the “Act”) came into force on September 1, 2000. Its purpose is to implement organizational arrangements pertaining to fire safety within the regional county municipalities (“RCMs”) and major urban centres in Quebec. Section 8 of the Act requires them to establish a fire safety cover plan (a “Plan”) which must then be approved by the Minister of Public Security ...
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 ...
1. International anti-corruption conventions To which international anti-corruption conventions is your country a signatory? Chile is a signatory to and has ratified the Inter-American Convention against Corruption, the OECD Convention on Combating Bribery of Foreign Public Officials in International Business Transactions, and the United Nations Convention against Corruption. 2 ...
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 new Immigration Bill was passed by the Indonesian Parliament on 7 April 2011. It will pass into law on the day it is signed by the President or within 30 days of its passage, whichever occurs earlier.The bill covers a range of basic matters relating to immigration, including entry to and exit from the Indonesian territory, travel documents, visas, stay permits, etc ...
Are donations of counterfeit goods to charities socially acceptable? - Despite calls for seized counterfeit goods to be donated to charity, a number of conditions should be met in order to protect both IP rights holders and those receiving the goods Nobody would dispute that in today’s world, the social and environmental impacts of our actions must be taken into consideration whenever we make a decision ...
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 ...
On April 4, 2011, the U.S. Patent and Trademark Office (USPTO) issued a Final Rule implementing the prioritized examination track (“Track I”) of its new examination timing control procedures.1 Under Track I, patent applicants can accelerate examination of certain patent applications that are filed on or after May 4, 2011 ...
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 ...
