In recent remarks to a compliance conference for the pharmaceutical industry, the SEC’s Director of Enforcement, Andrew Ceresney, addressed FCPA issues that commonly arise in the industry. According to Ceresney, the SEC is continuing to focus on pharmaceutical companies because their operations typically pose a high risk for FCPA violations ...
Understanding the Texas Attorney General’s efforts on enforcement of healthcare fraud and abuse matters often is challenging. Recent activities, however, give physicians and other providers insight into the agency’s priorities ...
On March 10, 2015, the Centers for Medicare & Medicaid Services (CMS) Innovation Center released its newest model in alternative care delivery: the Next Generation ACO Model. This new version of accountable care organization (ACO) builds upon the experiences from the Pioneer ACO Model and the Medicare Shared Savings Program (MSSP) to set more predictable financial targets, enable providers and beneficiaries to better coordinate care, and provide overall high quality care ...
In an opinion that will certainly cause Texas hospitals, physicians, nursing home operators and other healthcare providers to consider whether they should insert standard arbitration clauses into their pre-treatment agreements, the Texas Supreme Court held last week that the Federal Arbitration Act (“FAA”) preempts the more stringent arbitration requirements set forth in the Texas Medical Liability Act (“TMLA”).The Fredericksburg Care Co., L.P. v. Juanita Perez et al, No. 13-0573, 2015 Tex ...
On February 26, 2015, the Supreme Court of Canada dismissed Dr. Gilbert Liu's application for leave to appeal a Court of Appeal decision concerning the time limit for handling complaints from users of health institutions ...
Download a free copy of the Philippine section of Getting the Deal Through: Life Sciences 2015, which was contributed by SyCipLaw partners Rose Marie M. King-Dominguez and Carlos Roberto Z. Lopez with senior associate John Paul V. de Leon and associate Mark Xavier D. Oyales.This chapter is reproduced with permission from Law Business Research Ltd ...
The phrase ‘Je suis Charlie’ became one of the most popular twitter hashtags in history following the attacks on the offices of Charlie Hebdo, a French satirical magazine. Nearly 6,500 tweets were sent per minute containing the phrase first coined by artist Joachim Roncin and which has come to symbolise freedom of speech and freedom of the press. However, there have also been several attempts to register the phrase as a trademark ...
Just before Americans sat down to enjoy the Thanksgiving holiday with family and friends, with many of them probably choosing to overlook the total calorie count of those meals, the FDA released the long awaited rule on nutritional labeling applicable to chain restaurants and other venues serving restaurant type food (79 FR 71156). The FDA’s final menu labeling rule implements certain amendments to the Food, Drug & Cosmetic Act ("FD&C Act") that were part of the Affordable Care Act of 2010 ...
On December 1, 2014, the Department of Health and Human Services Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule that included numerous changes for accountable care organizations (“ACOs”) participating in the Medicare Shared Savings Program (“MSSP”) in light of the experience CMS gained during the first two years of the program ...
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”) ...
Finding that the taking of photography is entitled to the same First Amendment protection as photographs themselves, the Texas Court of Criminal Appeals struck down the state's "improper photography or visual recording" statute, a statute that made it a crime to photograph or record someone in a place other than a bathroom or private dressing room without their consent and "with the intent to arouse or gratify the sexual desire of any person." Ex Parte Thompson (Tex. Ct. Crim. App. Sept. 17 ...
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 ...
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 ...
On August 29, 2014, Normative Resolution N. 112 was published, amending Article 4 of Normative Resolution N. 98 of November 14, 2012. Normative Resolution 112/2014 provides that the temporary visa item V can be granted to foreign nationals who will enter Brazil to work exclusively in the preparation, organization, planning and execution of the 2016 Rio Olympic and Paralympic Games and who do not have a Brazilian sponsoring company or any employment relationship with a Brazilian company ...
In Belgium, although a sportsman is deemed to accept the normal risks linked to the exercise of his sport, he can claim damages for injuries inflicted on him by another player, to the extent that the perpetrator failed to meet the standard of general due diligence.1 The action of the player causing the injury is measured against the behaviour that would have been displayed by another reasonable sportsman placed under the same conditions ...
Last month a USA court found that a hit song performed and co-written by Shakira was in fact copied from an earlier work. So what happened? Shakira had previously collaborated with Dominican rapper El Cata on the song 'Loca'. The song, which sold over 5,000,000 copies worldwide, also featured on her album 'The Sun Comes Out' ...
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 ...
Who knows why Luis Suarez bit Giorgio Chiellini at the FIFA World Cup 2014. Perhaps it’s a compliment to great Italian defending? Or something to do with the increasing demands of the modern game? Whatever the answer may be, none of us truly believe that this sort of thing is acceptable. But precisely what are the rules that regulate this sort of conduct? Most of us were told not to bite when we were very young - so that we know ...
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 ...
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 ...
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 ...
