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 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 ...
A divided Supreme Court held that the Environmental Protection Agency (EPA) exceeded its authority under the Clean Air Act (CAA) when it required certain sources emitting greenhouse gases (GHG) to obtain permits under the Prevention of Significant Deterioration (PSD) and Title V Operating Permits (Title V) programs. The decision in Utility Air Regulatory Group v. EPA (No. 12-1146) on Monday, June 23, reversed the decision of the D.C. Circuit Court of Appeal that upheld EPA’s rules ...
Consistent with President Obama’s Climate Action Plan, EPA today published two sets of proposed rules, which it refers to as “carbon pollution standards,” relating to greenhouse gas emissions from fossil fuel-fired electric generating units - for existing stationary sources (79 Fed. Reg. 3480) and for modified and reconstructed sources (79 Fed. Reg. 34980). The publication of these proposals starts the clock running on comments, which are due on or before October 16, 2014 ...
After 115 years under the old regime, the new Water Sustainability Act received Royal Assent on Friday May 20, 2014: an historic occasion to celebrate? Not quite yet, perhaps. The fact is the vast majority of the new statute will not have the force of law until authorized by the Lieutenant Governor in Council at an unspecified future date (section 219). With new water regulations not expected until the spring of 2015, it seems that the new Act will not be binding until that time ...
The Comprehensive Environmental Response, Compensation and Liability Act, commonly referred to as CERCLA or Superfund, does not contain any provision for a private cause of action for personal injury or property damage relating to the release of hazardous substances ...
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 ...
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 ...
Quebec regulations create numerous obligations in connection with equipment that poses a risk to the environment. Replacing PCB-containing transformers, for example, or having high-risk oil and gas equipment inspected. Regulatees may be required to file reports, maintain registers or hold permits. From a regulatory perspective, the management of ozone depleting substances is a big file ...
On April 1, 2014, the Superior Court issued an interesting decision respecting consent to care1. The Quebec City CHU petitioned the Superior Court in order to be authorized to provide care for a 60‑day period to a patient despite the refusal of her parents. On March 14, the 22 years old patient suffered cardiac arrest following an intravenous drug overdose ...
On March 28, 2014, the White House released its Climate Action Plan Strategy to Reduce Methane Emissions. The oil and natural gas sectors are clearly in the cross-hairs for reductions. The report indicates the oil and natural gas sector was responsible for 28 percent of man-made methane emissions in 2012—second only to the agricultural sector, which accounts for 36 percent of emissions ...
The Constitutional Court has confirmed a decision of the Western Cape High Court that section 44 of the Land Use Planning Ordinance is unconstitutional and invalid, thereby closing off the ability of developers and objectors to appeal to province to overturn and replace unfavourable rezoning, subdivision and departure decisions made by local authorities ...
When the National Environmental Management: Waste Act, 59 of 2008 (“NEMWA”) came into operation, in July 2009, the operation Part 8 of Chapter 4 (the “Contaminated Land Provisions”) was deferred to a later date. In terms of a recent government gazette, [1] the Contaminated Land Provisions will now come into operation on 2 May 2014 ...
This paper is a virtual, international roundtable discussion of recent developments in environmental law, including developments pertaining to sustainability and energy development. The questions and answers include a discussion of recent greenhouse gas permitting developments in Texas, the role of sustainability in project development, measures for a corporation to take to become sustainable, hot issues in the environmental area, and the environmental impact of fracking. 4 ...
The U.S. Environmental Protection Agency and the U.S. Army Corps of Engineers recently released a proposed rule on the definition of “waters of the United States” under the Clean Water Act. If enacted, the rule could create significant new hurdles for real estate development projects that are near streams or wetlands by effectively removing permitting authority from state agencies and establishing federal oversight by the EPA and the Corps ...
The release of the second installment of the Intergovernmental Panel on Climate Change’s Fifth Assessment Report on March 31, 2014, provoked the usual calls for urgent and immediate action in response to climate change, including in particular at the international level in the form of a new climate treaty built upon domestic regulatory regimes.1 Irrespective of whether these calls for action are overly strident or carefully measured, the law plays a central role ...
In terms of section 29 of the National Environmental Management: Air Quality Act 39 of 2004 (“NEMAQA”), which provides for pollution prevention plans: “(1) the Minister of Environmental Affairs (the “Minister”) may: (a) declare any substance contributing to air pollution as a priority air pollutant; and (b) require persons falling within a category specified in the notice to prepare, submit to the Minister or MEC1 for approval, and implement pollut
As you no doubt already know, the Pharmaceutical Industry in Argentina is a strictly controlled industry. Said control is held by the ANMAT Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) and it spreads from the first authorisation of a laboratory to act as such in the country, moving through the authorisations to commercialise products, up to pharmacovigilance of products that have already been commercialised ...
In one of the few decisions of its kind, the UK High Court recently assessed the damages to be paid to a generic pharmaceutical company under a cross-undertaking in damages. While some aspects of the decision are specific to the UK pharmaceutical reimbursement scheme, the judgment will be a useful reference point for parties involved in similar litigation in Australia ...
CMS recently announced yet another delay to the full implementation of “two midnight rule,” which revises its longstanding guidance to hospitals and physicians relating to when hospital inpatient admissions are deemed to be reasonable and necessary for payment under Medicare Part A. Specifically, this latest “delay” is the result of CMS’s extension of the “Probe & Educate Period,” a period of partial non-enforcement for the two midnight rule requirements, until September 30, 2014 ...
Administrative fines and increased fees for exploitation of the environment are increasingly included in environmental regulations as sanctions. Lawmakers in Poland more and more often provide for administrative financial sanctions for environmental violations because they are more convenient to enforce than criminal sanctions, which require proof of fault on the part of a specific perpetrator. Moreover, criminal liability may be imposed solely on individuals ...
