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 ...
The Competition Commission of India (CCI) has conducted India’s first dawn raid. The CCI raided offices of UK-based construction equipment maker JCB, earlier today, in connection with a case of abuse of a dominant position. The Indian Competition Act (Act) accords power to the Director General (DG) to conduct such raids after obtaining a warrant from the chief metropolitan magistrate ...
On August 26, 2014, Judge Robert D. Drain of the Bankruptcy Court for the Southern District of New York issued a bench ruling in In re MPM Silicones, LLC, Case No. 14-22503 (RDD), on several aspects of the plan of reorganization filed by debtor Momentive Performance Materials, Inc., a specialty chemicals manufacturing company, and its affiliated debtors ...
The Draft Report of the Competition Policy Review released yesterday aims to set the pathway for resuscitating productivity growth in Australia, shining a light on areas of the economy in need of reform. It focuses on what is needed to promote productivity enhancing choice, diversity and innovation and focussing on areas such as health, planning laws, power and road transport. The Draft Report recommends changes to key competition laws that apply to all Australian businesses ...
Two top officials of the U.S. Department of Justice Antitrust Division have spoken publicly in the last week about corporate compliance programs. Brent Snyder, Deputy Assistant Attorney General for criminal enforcement entitled his remarks to the International Chamber of Commerce in New York as “Compliance is a Culture, Not Just a Policy ...
On August 15, 2014, the Eleventh Circuit entered a Memorandum Opinion in the Wortley v. Chrispus Venture Capital, LLC case (In re Global Energies, LLC, “Global”)1 unwinding a section 363 sale order entered in 2010 by the Bankruptcy Court for the Southern District of Florida based on a finding of bad faith in the filing of an involuntary bankruptcy case in 2010 ...
On September 3, 2014, the United States Court of Appeals for the Fifth Circuit entered an opinion vacating various orders of the United States Bankruptcy Court and District Court for the Southern District of Texas (the “Bankruptcy Court” and the “District Court”) in the bankruptcy cases of TMT Procurement Corporation and its affiliated debtors (the “Debtors”), including a final order approving the Debtors’ post-petition debtor in possession financing (the “DI
Vice Chancellor Laster of the Delaware Court of Chancery recently applied the business judgment standard of review at the pleading stage to dismiss a complaint challenging a cash-out merger involving a controlling stockholder. This is one of the first decisions applying the Delaware Supreme Court’s recent decision in Kahn v. M&F Worldwide Corp ...
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 Texas Supreme Court denied a petition for review stemming from the Houston Court of Appeals’Barzoukas v. Found. Design, Ltd. decision.1 The case is significant because of its application of the economic loss rule (under Texas law) in the context of an owner-subcontractor dispute ...
On 5 August 2014, the National Assembly of the Republic of Serbia enacted the Law on amendments and additions to the Insolvency Law (“New Law”). The New Law came into force on 13 August 2014. It has been specified that insolvency proceedings that have not been completed on the day the New Law comes into force will be completed in accordance with the previous rules ...
On 5 August 2014, the National Assembly of the Republic of Serbia enacted a new Privatisation Law (“New Law”), which came into force on 13 August 2014. The New Law prescribes for the privatisation process to be completed before 31 December 2015. The four models of privatisation that have been prescribed include sale of capital, sale of assets, transfer of capital without compensation and strategic partnership. It also allows for the possibility to combine these models ...
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 ...
A recent report in Fin24 entitled ‘MTN named SA and Africa’s strongest brand’ listed South Africa’s top 50 brands in terms of brand value. It was based on research done by the brand valuation company, BrandFinance. As the title suggests, MTN came out on top, followed by Sasol, Vodacom, Standard Bank, Absa, Nedbank, FNB, Mediclinic, Investec and Woolworths. Of the top 50 brands, 16 are in the food and beverages sector, 13 in financial services, and five in telecoms ...
The standards for Section 11 liability for statements of opinion in registration statements is the subject of a split between the federal circuit courts. The Tenth Circuit joined the split in the recently issued opinion, MHC Mutual Conversion Fund v. Sandler O’Neill & Partners, et al. The Supreme Court is scheduled to resolve this split next term in the Omnicare1 case, which is currently being briefed before the high court ...
On June 10, 2014, the Public Company Accounting Oversight Board (the “PCAOB”) adopted Auditing Standard No. 18 (“Standard No. 18”), which amends and supplements existing auditing standards regarding related party transactions, significant unusual transactions and financial relationships and transactions with executive officers. Standard No. 18 also expands the required communications that an auditor must make to the audit committee related to these areas ...
On August 1, 2014, certain amendments to the Delaware Limited Liability Company Act, 6 Del. C. §§ 18-101, et seq. (the “LLC Act”), the Delaware Revised Uniform Limited Partnership Act, 6 Del. C. §§ 17-101, et seq. (the “LP Act”), and the Delaware Revised Uniform Partnership Act, 6 Del. C. §§ 15-101, et seq. (the “GP Act”) became effective ...
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 ...
Regulators around the world remain focused on the impact of cartels on business, and the Australian Competition and Consumer Commission (ACCC) is no exception. In 2013 the ACCC received 27 approaches in relation to cartels, resulting in 13 in-depth investigations. International cooperation in this area is increasing, due significantly to the work of the International Competition Network, the global organisation of competition regulators ...
