On November 4, 2014, voters in Denton made that city the first in Texas to ban hydraulic fracturing within city limits. Within a day, lawsuits were filed by the Texas General Land Office and the Texas Oil and Gas Association, and state lawmakers and regulators voiced strong opposition to the ballot measure ...
In an opinion published on November 11, 2014, Connecticut joined a growing number of jurisdictions that have found that state law causes of action based on a health care provider’s unauthorized disclosure of a patient’s medical records are not preempted by the Health Insurance Portability and Accountability Act (“HIPAA”) ...
The Fifth Circuit Court of Appeals has held that a contractor’s breach of an express warranty to repair does not constitute an “assumption of liability in a contract or agreement” for purposes of the “contractual liability” exclusion found in most general liability policies ...
With the recent announcement to extend the waivers of certain fraud and abuse laws for accountable care organizations (ACOs) participating in the Medicare Shared Savings Program (MSSP), ACOs can continue using the waivers in their current form - at least for now ...
On September 9, 2014, the U.S. Food and Drug Administration (FDA) published the inaugural “Purple Book,” a list of approved or “licensed” biological products, including all biosimilar and interchangeable biological products. The Purple Book is more formally known as “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.” The Purple Book is meant, at a fundamental level, to be the biological equivalent of the “Orange Book ...
I. Intact, compagnie d’assurances v. Théberge & Belley (1985) inc. and l’Union canadienne compagnie d’assurance and EBC inc.1In this case, the Court of Appeal held that an insurer who indemnified its insured pursuant to “contractors’ equipment” coverage cannot exercise its subrogation rights against the subcontractor who committed a fault.FACTSEBC was the general contractor for the construction of a deep water wharf ...
On October 3, 2014 the Department of Health and Human Services, Office of Inspector General (“OIG”), released a proposed rule to add new safe harbors to the Anti-Kickback Statute (“AKS”) and to amend the definition of “remuneration” in the Civil Monetary Penalties (“CMP”) regulations. The OIG additionally solicited comments on same which must be submitted no later than 5 pm EST on December 2, 2014 ...
On October 3, 2014, the Supreme Court of Canada, by a majority decision of 5 to 4,1 confirmed that a disposition ordering the treatment of an accused who is found unfit to stand trial requires the prior consent of the designated hospital to all the terms of the disposition order, inclusive of the date on which the treatment is to begin ...
You are in charge of finances for a small business and are on vacation at the beach. Suddenly, you remember you have forgotten to pay a company bill. All is not lost, you think. You run to you room, grab a laptop, and bring it down to the Tiki Bar. There, you order a drink and connect to the hotel's wireless system. Then you call up your company's bank's Web page, click the "log-in" button, enter your password, and order a check issued to the creditor ...
In an unanimous decision dated September 4, 20141 , the Court of Appeal confirmed that the 45-day time limit under the Act Respecting Health Services and Social Services2 (ARHSSS) to allow the medical examiner and the local service quality and complaints commissioner to process a user complaint is not mandatory but rather serves to indicate that the Legislator intends the complaint to be diligently processed ...
The draft regulations for OTC derivatives have been released, which means that change is in the air. The government is stepping forward into unchartered territory and is set to regulate an area which has never been regulated before. Following our recent breaking news on the draft regulations, ENSafrica will, over the coming weeks and months, unpack the regulations for you, highlighting all the essentials. What follows is a sneak peak at affected areas and a snapshot of the bigger picture ...
As noted in numerous recent publications, captives have been receiving an increased amount of regulatory attention, not just from the domicile states which regulate them, but, more significantly, from national or international bodies. The NAIC Captives and Special Purpose Vehicles Working Group completed its examination of captives and now two captive related proposals are being considered at the NAIC ...
On July 16, 2014, the Sixth Circuit Court of Appeals confirmed that a “health care provider can bring the Medicare Secondary Payer Act’s (“MSP’s”) private cause of action against a non-group health plan that denies coverage for a reason besides Medicare eligibility.” In Michigan Spine & Brain Surgeons, PLLC v. State Farm Mutual Automobile Insurance Co., the Court clarified a key holding in its prior decision in Bio-Medical Applications of Tennessee, Inc. v ...
This past June marks nine years since the data breach at CardSystems Solutions, which involved the disclosure of names, account numbers and verification codes for some 40 million cardholders. Next month, we will pass the eight-year anniversary of the data breach at Monster.com, which involved the disclosure of contact information for some 1.3 million users ...
New technology is most often associated with telecommunications, IT or robotics. Food is seen as a group of products in which innovation is little important, because it is believed that consumers are mostly concerned with prices and quality, but not innovations. However, the dynamic growth in market share of functional foods calls for a critical review of myths that have arisen around R&D projects in the food sector ...
This year marks the 30th anniversary of the passage of the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act (FD&C Act). Considered to be one of the most successful pieces of legislation ever enacted, the Hatch-Waxman Amendments created the modern generic drug industry, which is responsible for dramatically increasing the availabilty of low-cost generic drugs and saving the U.S. healthcare system billions of dollars ...
In a win for policyholders relying on multiple coverage layers, the Fifth Circuit held on June 23, 2014 that an excess liability insurance policy could be triggered by exhaustion of a “retained limit” - equal to the limits of underlying insurance - even if the amounts paid to meet the “retained limit” were not covered by the excess policy. Indemnity Insurance Co. of N. Am., et. al. v. W & T Offshore Inc., -- F.3d --, No. 13-20512 (5th Cir. June 23, 2014) ...
An employer faces a difficult situation when a temporarily disabled employee who cannot perform his or her essential job functions requests an accommodation. This situation becomes significantly more complicated when the employee receives the “accommodation,” but never recovers enough to resume performing the essential job functions ...
LabMD, Inc. renewed its argument that the FTC lacks authority to regulate the data security practices of HIPAA covered entities by appealing the dismissal of its case for lack of jurisdiction (see our coverage here) to the Eleventh Circuit. LabMD also filed an emergency motion seeking expedited briefing and requesting an order enjoining the administrative proceedings until the appellate court rules on the merits of its argument ...
On 1 April 2014 amendments to the Contributions Act increasing the general rate for health insurance contributions from 13% to 15% came into force. The new contribution rate will be applied to salaries beginning in April 2014. Receipts related to previous periods will be grandfathered in at the previous applicable rate. Unused vacation for 2013 will be calculated at the 13% contribution rate and the new rate will apply to unused vacation in 2014 ...
The healthcare industry will have to wait for a court to answer the question of whether the United States Federal Trade Commission (the “FTC”) has authority to regulate data security practices of entities covered by the Health Insurance Portability and Accountability Act (“HIPAA”). On Monday, a federal district judge dismissed LabMD, Inc.’s case without reaching the merits, declining to disrupt the underlying administrative proceeding ...
Regional governments in Sweden are increasingly looking to leverage their purchasing power in order to secure discounts and rebates on the list prices of branded drugs. However, as noted by Elizabeth Eklund, Partner at leading commercial law firm Delphi, such agreements risk running foul of both Swedish and European Union (EU) law ...
It seems every week, there is a new story about a company being impacted by a major data breach and the consequences that follow from such breach, including the inevitable lawsuits, public relations nightmare, and governmental investigations. These breach stories are then followed by articles about the high costs to deal with these breach events, including costs to notify consumers, to identify the source of the breach, to pay for credit monitoring, among many other costs ...
Texas operators and service companies need to carefully consider how a recent trend in Texas law affects the availability of insurance coverage - for themselves and their counterparties - for contractual liability. Most general liability policies, which insure claims for bodily injury and property damage, exclude coverage for liability assumed under a contract, unless the liability either exists in the absence of the contract or was assumed in a defined “insured contract ...
