Grid Code amended In December of last year, the Serbian Transmission System Operator amended the Grid Code. These amendments did not substantially change the code, but did introduce changes in: - technical conditions for connecting to the grid, including specific conditions for connecting generating units, and - access to the grid. The amendments are published in the Official Gazette of the Republic of Serbia no. 02/12 ...
If you have ever had a project on land on which wetlands or other “waters of the U.S.” were present, you know that project was more expensive because of the costs of permitting and mitigation for wetland losses, or the presence of wetlands may have resulted in abandonment or significant revision of the project to minimize losses of wetlands or other waters of the U.S. In their prior two “waters of the U.S.” decisions, Solid Waste Agency of Northern Cook Cty. v. Army Corps of Engineers, 531 U ...
The wait is over. On January 17, 2013, the Department of Health and Human Services’ ("HHS’") Office for Civil Rights ("OCR") released its long-anticipated megarule ("Omnibus Rule") amending the HIPAA Privacy, Security, Breach Notification and Enforcement Rules. These amendments implement and expand on the requirements of the Health Information Technology for Economic and Clinical Health ("HITECH") Act and the Genetic Information Nondiscrimination Act of 2008 ...
The long awaited Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Regulation amendments (the “Changes”) to incorporate the changes made by Health Information Technologyfor Economic and Clinical Health (HITECH) in 2009 as part of the American Recovery and Reinvestment Act and by the Genetic Information Nondiscrimination Act (“GINA”) were recently released ...
On December 5, 2012, EPA issued revised enforcement guidance to assist agency personnel in exercising enforcement discretion regarding the treatment of tenants under Superfund’s bona fide prospective purchaser (BFPP) defense. (See here.) The revised guidance supersedes guidance the agency had issued on January 14, 2009 and expands some of the protections ...
Total Maximum Daily Loads, or TMDLs, serve a profoundly important function under the federal Clean Water Act. They provide regulators with a systematic and comprehensive mechanism for identifying all sources and causes of water quality impairment, and then calculating the reductions needed to address the impairment in an equitable manner. But for TMDLs to be effective, they must be derived in a legally and technically defensible manner ...
Under the Patient Protection and Affordable Care Act (“PPACA”), an employer that employs an average of at least 50 full-time and full-time equivalent employees (a “Large Employer”) during 2013 may be subject to a penalty in 2014 if the Large Employer fails to offer “minimum essential coverage” to all but 5 percent (or, if greater, five) of its full-time employees (“No Coverage Penalty”) ...
Sixteen years since the enactment of Law No. 7 of 1996 regarding Food (“the 1996 Food Law”), the Government issued the new Food Law (ie Law No. 18 of 2012) (“Food Law”) on 18 October 2012, two days after World Food Day. The Food Law replaces The 1996 Food Law. The Food Law covers three significant areas which were not governed by the 1996 Food Law, ie imports of food; the halal requirement; and the establishment of a new non-ministerial agency in-charge of food matters ...
On January 16, 2013, the Environmental Protection Agency (EPA) submitted the final 2013 Vessel General Permit (VGP) to the White House Office of Management and Budget (OMB) for review. The 2013 VGP, which will be issued under the Clean Water Act (CWA), will replace the 2008 VGP and will regulate discharges incidental to the normal operation of commercial vessels greater than or equal to 79 feet in length. See 76 Fed. Reg. 76,716 (Dec. 8, 2011) ...
The new Waste Act of 14 December 2012 went into force on 23 January 2013. It introduces major changes in the waste management system in Poland. The prior Waste Act of 27 April 2001 will continue to apply in certain areas, however. The new Waste Act was enacted primarily in order to implement the Waste Framework Directive (2008/98/EC) into Polish law. The deadline for transposing the directive was 12 December 2010 ...
One of the provisions of the West Virginia Horizontal Well Control Act passed in December 2011 increased the permit fees for horizontal wells from $400 to $10,000. At the time this legislation was under consideration, West Virginia Department of Environmental Protection Secretary Randy Huffman told the legislature that the increased permit fee would allow him to nearly double the Inspection and Enforcement staff within the Office of Oil and Gas, which at that time numbered 17 ...
It took thirteen years, four months, and five days of heated debates and passionate protests before the country’s first reproductive health law was passed. Four days shy of Christmas last year, President Aquino finally signed the 24-page bill into law. It is now Republic Act No. 10354 or The Responsible Parenthood and Reproductive Health Act of 2012 (RH Law). The passing of the RH Law, however, does by no means close this chapter of Philippine history ...
On February 5, 2013, the United States District Court for the Middle District of Pennsylvania granted Tennessee Gas Pipeline Co. LLC’s (“TGPC”) motion for an emergency preliminary injunction preventing Pennsylvania’s Environmental Hearing Board (“EHB”) from reviewing permits issued by Pennsylvania’s Department of Environmental Protection (“DEP”) to TGPC associated with its Northeast Upgrade Project (“Project”) ...
A federal court jury in Illinois found that nursing home operator Momence Meadows fraudulently billed Medicare and Medicaid for “worthless services” and falsely certified compliance with health care laws and regulations, resulting in $28 million in damages to the government. United States ex rel. Absher v. Momence Meadows Nursing Ctr., Inc., No. 2:04-cv-02289 (C.D. Ill. Feb. 8, 2013) ...
An interview with Weronika Pelc, the partner in charge of the Energy Law Practice at Wardynski & Partners, and Michal Barlowski, the partner in charge of the Bankruptcy and Restructuring practices at Wardynski & Partners, about shale gas projects in Poland. You recently visited Houston at the invitation of the law firm of Haynes and Boone for a seminar on shale gas mining in Poland ...
Just as it seemed that the South African Government’s appetitefor introducing the carbon tax was waning we were informed by the Minister of Finance that the long awaited carbon tax policy paper will be released by the end of March 2013. The carbon tax policy paper is expected to be an update of the carbon tax discussion paper that was published for comment in December 2010 ...
On March 28, 2013, the Environmental Protection Agency (EPA) issued the final National Pollutant Discharge Elimination System (NPDES) Vessel General Permit (VGP). The 2013 VGP, issued under the Clean Water Act (CWA), replaces the 2008 VGP and regulates discharges incidental to the normal operation of commercial vessels greater than or equal to 79 feet in length.1 The 2013 VGP will be effective on December 19, 2013, when the current 2008 VGP expires ...
The decision of the Indian Supreme Court to deny Novartis’s application for patent protection for an improved version of its patented Glivec drug – the culmination of a seven-year battle - has certainly made the headlines. There are a number of reasons for this. First, Glivec is a well-known drug – described by some as a ‘wonder drug’ – that’s used to combat cancer, including leukaemia and gastro-intestinal cancer ...
On April 17, 2013, the Health and Human Services Office of Inspector General (OIG) released an Updated Provider Self-Disclosure Protocol (SDP), which replaces the original SDP published in 1998. The SDP is used by providers and suppliers to voluntarily disclose violations of the fraud and abuse laws. According to the OIG, it has received more than 800 disclosures since the SDP’s inception, resulting in more than $280 million in recoveries ...
Last week, a federal jury in South Carolina found that Tuomey Healthcare System, Inc. violated the Stark Law and the False Claims Act by submitting false claims for reimbursement to the United States, resulting in $39 million in damages to the government. United States ex rel. Drakeford v. Tuomey Healthcare Sys., Inc., No. 3:05-2858-MBS (D.S.C. May 8, 2013) ...
After the Netherlands, Slovakia, and the UK, it is now France’s turn to impose Sunshine-like obligations on the pharmaceutical industry. Soon, similar obligations will apply to all EU countries, after EFPIA, the European trade association for the pharmaceutical industry, adopts a code of conduct on disclosure of transfers of value between pharmaceutical companies and health care professionals or institutions ...
On May 28, 2013, the US Food and Drug Administration (FDA) published a draft guidance entitled "Contract Manufacturing Arrangements for Drugs: Quality Agreements."1 The draft guidance describes FDA’s views on defining, establishing and documenting the responsibilities of parties that are involved in the contract manufacturing of drugs that are subject to current good manufacturing practice (cGMP) requirements ...
As discussed in our previous Alert, the French government has imposed Sunshine-like obligations on the pharmaceutical industry. Article 2 of Law No 2011-2012 of 29 December 2011 on the Strengthening of Health Protection for Medicinal and Health Products ("loi relative au renforcement de la sécurité sanitaire du médicament et des produits de santé" or "Loi Bertrand") inserted Articles L. 1453-1 in the French Code of Public Health ("Code de la santé publique" or "CSP"). Article L ...
