The Centers for Medicare and Medicaid Services (CMS) on February 16, 2012 proposed rules1 implementing Section 6402(a) of the Affordable Care Act,2 requiring persons to report and return Medicare overpayments by the later of 60 days after an overpayment is identified or the date any corresponding cost report is due. Twice in the past, CMS had proposed rules requiring the return of Medicare overpayments, but did not finalize the regulations ...
Healthcare providers and other HIPAA covered entities have until Wednesday, February 29, 2012 to submit notice of breaches of unsecured Protected Health Information which affected fewer than 500 individuals during 2011. Notice must be submitted electronically to the Secretary of Health & Human Services, and separate forms are required for each data breach occurring in the course of the calendar year ...
On February 24, 2012, two years after oral argument, the Texas Supreme Court issued its watershed decision in Edwards Aquifer Authority (the “Authority”) v. Day. The Court’s long-awaited decision included two significant pronouncements on groundwater that are likely to have ripple effects throughout the water community and could open the flood gates to a wave of litigation ...
The Stage 2 Meaningful Use requirements proposed last week by CMS as part of the Medicare and Medicaid incentive programs to expand the use of Electronic Health Record (EHRs) maintain the same core and menu structure as the Stage 1 criteria. The proposed rule, however, gives providers an additional year, until 2014, to implement Stage 2 criteria ...
On March 21, 2012, the United States Supreme Court issued a unanimous decision in the much-publicized case of Sackett v. EPA (No. 10-1062), less than three months after oral argument, holding that the Sacketts were not precluded from judicially challenging EPA’s issuance of an administrative compliance order ...
On March 13, 2012, the Standing Committee on Environment and Sustainable Development issued recommendations for improving the Canadian Environmental Assessment Act (CEAA) process (click on Print Format for the complete report). The recommendations focus on: improving timeliness; decreasing duplication with provincial processes; improving aboriginal consultation processes; and improving outcomes ...
Law no.11/2012 of 8 March establishes new rules for prescription and dispensing of medicines. Prescriptions for medicines must now include the International Nonproprietary Name (INN) of the active substance,its pharmaceutical form, the dosage, the presentation and the posology. The prescription may also include a trade name by brand or indication of the name of the holder of the marketing authorisation ...
On Wednesday, March 22, the United States Supreme Court ruled that a compliance order issued under EPA’s Clean Water Act enforcement authority to individuals for allegedly filling part of their property without the necessary “dredge and fill” permit could be challenged in federal district court. The ruling marks a major loss for EPA’s enforcement practices under the Clean Water Act ...
On March 26, 2012, the Fifth Circuit Court of Appeals (“the Court”) vacated and remanded EPA’s disapproval of Texas’s request for approval of the minor source standard permit for pollution control projects (“PCP”) as part of its air quality state implementation plan (“SIP”). The Court’s reasoning may also affect other pending disputes between EPA and Texas regarding air quality permitting and other issues ...
In response to a court order, EPA has announced proposed rules that would establish new source performance standards (“NSPS”) applicable to greenhouse gas emissions from new, fossil fuel-fired power plants (“power plants”). The proposal is a highly controversial one, which will effectively prohibit the construction of coal-fired power plants that do not capture carbon ...
After three days of historic oral arguments before the U.S. Supreme Court, the fate of the Affordable Care Act (ACA), the momentous 2010 health reform law, is uncertain, given robust questioning of the ability of Congress to force individuals to purchase health insurance ...
The U.S. Fourth Circuit Court of Appeals has reversed a $44 million judgment against Tuomey Hospital in Sumter, South Carolina that arose from Tuomey’s employment arrangements with physicians that allegedly violated the federal Stark Law.1 The Stark Law prohibits hospitals from submitting claims to Medicare for designated health services that were referred by physicians with whom the hospital has a financial relationship, unless the relationship fits within an exception ...
In Greek mythology, Prometheus stole fire from Zeus to give to mankind. It seems that Zeus is now reclaiming some of that fire in the guise of Mayo Collaborative Servs. v. Prometheus Labs., Inc., No. 10-1150 (U.S. Mar. 20, 2012), the Supreme Court’s latest decision addressing patent-eligible subject matter. But a practical analysis of Prometheus reveals strategies one can use in drafting patent claims to keep those claims burning ...
In order to comply with a court-ordered schedule, EPA Administrator Lisa Jackson on April 17, signed final rules that subject additional oil and gas operations, including hydraulic fracturing, to air quality regulation under the New Source Performance Standards (NSPS) and National Emission Standards for Hazardous Air Pollutants (NESHAPs) programs, and impose new and amended requirements under both programs ...
On April 17, 2012 the federal government announced its Plan For Responsible Resource Development, setting out further details on steps to implement proposals for streamlining the federal environmental assessment (“EA”) process. This Plan follows on the heels of the federal budget and the Statutory Review of the Canadian Environmental Assessment Act,[1] which both suggested that these streamlining reforms would be forthcoming ...
Energy security is ability of the State to choose how and under what conditions local consumers are to be provided with energy and energy resources. This ability is mainly determined by alternatives for usage of local energy sources, diversified imports, integrity of energy systems, and market-based formation of energy prices ...
For the past two years so-called 'monster rain' has hit Copenhagen in summer. The rain has flooded large areas in Copenhagen and neighbouring towns, and caused substantial damage to properties in the flooded areas, as well as closing major radial routes into Copenhagen. This update examines the ways in which the authorities intend to prevent damage caused by monster rain in future ...
On 23 February 2012, Government Regulation No. 27 of 2012 on Environmental Licenses (“GR 27/2012”) was issued to regulate AMDAL, UPL & UKL, and the contamination and destruction of the environment. GR 27/2012 is the implementing regulation for Articles 33, 41, and 56 of Law No. 32 of 2009 on Environmental Protection and Management which replaced Government Regulation No. 27 of 1999 on Environmental Impact Analysis ...
Three recent decisions bolster a generic manufacturer’s ability to challenge Orange Book listings and obtain ANDA approval through section viii “carve-outs.” In Caraco v. Novo Nordisk1 the U.S. Supreme Court unanimously held Caraco could use the Hatch-Waxman’s counterclaim provision to correct Novo’s overbroad use code. In AstraZeneca v. Apotex, the U.S ...
New amendments to the Regulation on Health Conformity of Dietetic Products have entered into force on 28 May 2012. Here are some of the most significant changes that are prescribed by these amendments to the Regulation. As a reminder, this is a regulation that introduced the obligation of the registration of dietetic products (including supplements) in July 2010, and is a regulation that regulates the issues of labelling and the composition of these products in details ...
The provision of gifts and hospitality to public officials has recently been the subject of a number of news stories in the Serbian media, covering not only the official reports on the variety of protocol gifts received by the high ranking officials from the leaders of other countries, but also the alleged corruption affairs involving the potential bribing of various lower-level officials by companies and individuals seeking an unfair advantage in the market ...
If you are in the oil and gas industry and you’ve experienced the recent onslaught of enforcement actions, particularly in the Appalachian basin, by the U. S. Environmental Protection Agency (“EPA”) you may take comfort in the aphorism: “You’re not paranoid if they really are out to get you!” A simple Google search of “EPA III Enforcement” and a click on the “Natural Gas Extraction/Marcellus Shale” link at the EPA Region III website should cause any company concern ...
The Supreme Court makes clear that a party that has started to clean up contamination caused by another party is also deemed to be a business operator. This gives rise to joint and several liability for the original contamination. The fact that remedial work was intended to reduce the environmental impact is of no importance. Background A company which was later incorporated into JM Värmdöstrand (“JM”) operated a casting works from the 1940s to the 1980s on a site in Oxelösund ...
The D.C. Circuit Court of Appeals has rejected the petitions of numerous states and industry groups that challenged several rules EPA issued to control greenhouse gas emissions from stationary and mobile sources.1 Following the United States Supreme Court’s decision in Massachusetts v ...
On January 24, 2011 the Attorney General of the Federal Republic of Brazil signed a document restricting the powers of ANVISA (Brazil’s regulatorybody) in the examination of pharmaceutical applications, giving the rights to the Brazilian PTO to do so without any interference of ANVISA. The dispute between ANVISA and the Brazilian PTO in the examination of pharmaceutical applications had apparently been solved ...
