The National Law Review is pleased to bring you information about the upcoming ABA Winter CLE Institutes:
ABA National Institutes
Learn and network at these live in-person seminars that draw lawyers from across the nation. January National Institutes include the 2013 E-Discovery and Information Governance, January 23-25 in Tampa, FL. February National Institutes include the 2013 Gaming Law Minefield, February 14-15 in Las Vegas, NV.
The National Law Review recently published an article by Robert B. Meyer and David L. Woodard of Poyner Spruill LLP, regarding Discrimination:
The U.S. Equal Employment Opportunity Commission has announced on its website that it continues to focus on what it considers to be ongoing religious and national origin discrimination in the workplace, especially against Muslim, Sikh, Arab, Middle Eastern, and South Asian Communities. The EEOC reports that in the initial months after the September 11, 2001 terrorist attacks, the Commission saw a 250% increase in the number of religion-based charges involving Muslims. Since that time, the EEOC states that it has continued to track an increase in such charges, as well as those alleging national origin discrimination against those with Middle Eastern background. While the Commission does not specify how many of those charges were found to have merit, it does report that it has filed nearly 90 lawsuits against employers, many of which involve alleged harassment on the basis of religion and national origin. Thus, it is apparent that the EEOC is aggressively pursuing investigation and enforcement activities in this area.
Title VII of the Civil Rights Act of 1964 prohibits employers from discriminating against employees or job applicants on the basis of religion or national origin. The harassment of individuals because of their religion or national origin is also prohibited. Through its interpretations of Title VII, The EEOC has recognized a wide range of actions and conduct that may be potentially unlawful, including: disparate treatment, teasing or insults because of a person’s appearance, customs, language, or accent; requiring employees to speak English in the workplace; disparate treatment, jokes, or insults toward an employee because of the national origin or religion of that person’s spouse; and adverse actions based on perceptions of an employee or applicant’s national origin or religion.
It is important to note that in addition to these prohibitions against discrimination and harassment, Title VII also requires employers to reasonably accommodate the religious practices of an employee or applicant, unless doing so would cause an “undue hardship” for the employer. The EEOC has suggested that reasonable accommodation may include, for example, providing employees with leave to attend religious observances, providing time and/or a place to pray, and permitting employees to wear religious attire in the workplace. However, the issue of accommodation requires the employer to consider each request for accommodation on a case-by-case basis in order to determine whether accommodation is possible and reasonable under the circumstances.
The EEOC also states that it has “intensified its outreach” to educate employees in this area of the law by issuing fact sheets on immigrant employee rights, employment discrimination based on religion and national origin, and employer responsibilities under Title VII with respect to the employment of Muslims, Arabs, South Asians, and Sikhs. These fact sheets provide specific examples of prohibited conduct in the workplace, and also offer instructions on how employees may file charges with the EEOC. Therefore, and in view of the EEOC’s emphasis on this particular form of discrimination, employers should review carefully these fact sheets as a part of their proactive compliance and training measures. Employers should also remember that retaliation against anyone who files a charge or otherwise opposes unlawful discrimination is expressly prohibited under Title VII.
© 2012 Poyner Spruill LLP
The National Law Review is pleased to bring you information about the upcoming 8th Annual General Counsel Insitute:
Success Strategies: Defining Success and Adding Value as In-House Counsel in the 21st Century.
November 8-9, 2012
Intercontinental Hotel
300 West 44th Street
New York, New York
Adding value as an in-house lawyer in the 21st century requires the ability to define and realize success for yourself, your department and your company. As General Counsel – or as someone reporting to the General Counsel – you need to be an insightful lawyer, thought leader and talent manager who understands your own strengths and “opportunity areas,” commits to grow and develop personally and professionally, and brings innovative change to your organization. Learn new strategies for success at NAWL’s 8th Annual General Counsel Institute.
In a concerted effort to enhance its ability to monitor energy markets for possible anti-competitive or manipulative conduct, FERC has undertaken a number of separate initiatives to strengthen its market surveillance capabilities over electric power and natural gas markets. Among the areas of focus, FERC has been especially keen on obtaining data and market information on a real-time, or near real-time, basis, which is in contrast to FERC’s traditional collection of data through quarterly or annual reports submitted well after-the-fact. FERC has also been intent on gathering data outside of organized wholesale electric markets.
These initiatives include:
Taken as a whole, these efforts show an agency intent on gaining a deeper and more granular perspective on energy markets and a better understanding of how those markets function day-to-day.
© 2012 Bracewell & Giuliani LLP
The National Law Review is pleased to bring you information about the upcoming Global Financial Markets – Operational and Technical Changes for FACTA Compliance:
FATCA is amongst the biggest topics of debate in financial institutions across the globe. The effect that it will have on these institutions cannot be underestimated and its operational impact on the existing systems is set to be both time consuming and costly. The ability to successfully align all key stakeholders, including operations, technology, risk, legal and tax, will determine the ultimate cost of FATCA compliance. Moving on from mere interpretive matters, this GFMI conference will not only address key FATCA requirements but also discuss the practical impacts of IGAs and strategies for achieving operational and infrastructural efficiency.
The Operational and Technical Changes for FATCA Compliance Conference will be a two and half day, industry focused event, specific to Senior Executives working in Banks, Insurance and Asset Management Companies. Attendees will address key FATCA requirements, while discussing the practical implications of IGAs and strategies for achieving operational and infrastructural efficiency.
Key Themes of the Operational and Technical Changes for FATCA Compliance Conference Include:
1. Challenges of FATCA regulations and prospects for the final regulation
2. Achieving operational and infrastructural efficiency
3. Coordinating existing AML/KYC procedures with FATCA compliance
4. FATCA from the FFI’s perspective 5. Beyond banking: the challenges of FATCA implementation
6. Coping with the withholding obligation under FATCA
This is not a trade show; our conference series is targeted at a focused group of senior level executives to maintain an intimate atmosphere for the delegates and speakers. Since we are not a vendor driven conference, the higher level focus allows delegates to network with their industry peers.
New England Compounding Center (NECC) distributed contaminated syringes that caused a meningitis outbreak – killing fifteen people in fifteen states. Officials estimate that as many as 14,000 patients may have received injections of steroids compounded by NECC from contaminated syringes.
The tragedy raises key questions with imprecise answers.
Linda Bentley, our colleague who advises clients on FDA regulatory issues, explained to WebMD Health News that the traditional role of compounding pharmacies is to make drugs prescribed by doctors for patients with specific needs that a commercially available drug cannot meet. Bentley offered two examples:
Compounding pharmacies generally cannot produce compounded drugs prior to receiving a prescription from a provider, provide compounded drugs for general distribution, or conduct other activities that may qualify them as drug manufacturers. But, as Bentley noted to USA Today, Food and Drug Administration(FDA) guidance can be confusing, and “there’s no bright line standard” for distinguishing between traditional compounding and manufacturing activities.
The FDA and individual state Boards of Pharmacy regulate compounding pharmacies, but the extent of each agency’s enforcement authority is unclear. The U.S. Drug Enforcement Agency also regulates compounding pharmacies when they handle controlled substances.
Compounded drugs are exempt from the FDA’s standard drug approval requirements under the Food, Drug, and Cosmetic Act, so the FDA has less authority over compounding pharmacies than over traditional drug manufacturers. A compounding pharmacy’s activities can cross the line that triggers FDA oversight, but when is not always clear. As Bentley describes in another article, “[i]t’s a gray area because there’s no clear standard as to when the pharmacy crosses the line and looks more like a manufacturer than a compounding pharmacy . . . I mean, that’s a big hole. The problem is that it’s hard to know where the edges are.”
Although state Boards of Pharmacy generally license and survey all pharmacies, including compounding pharmacies, the state may or may not have separate, more rigorous, regulations or license requirements in place for compounding pharmacies.
State and federal lawmakers will likely propose a variety of legislation aimed to increase oversight of compounding pharmacies and their practices. One possibility is that Congress and the FDA could define the activities compounding pharmacies must avoid to prevent being subject to regulation as a drug manufacturer more clearly. Alternatively, the NECC incident may bring about a new oversight regime for compounding pharmacies completely distinct from that applicable to drug manufacturers. States could also amend their pharmacy laws to create separate, more rigorous licensing and inspection standards for compounding pharmacies.
Additionally, state and/or federal law may require a compounding pharmacy to be accredited as other provider types are in the health care industry. Compounding pharmacies can currently seek accreditation by the Pharmacy Compounding Accreditation Board (PCAB), but few have. Of the thousands of compounding pharmacies that operate in the United States, less than 200 hold PCAB accreditation. PCAB-accredited pharmacies are located in only 38 states, and only 5 are located in Massachusetts, NECC’s home state.
*Copyright 2012 American Health Lawyers Association, Washington, D.C. Reprint permission granted.
©1994-2012 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
The National Law Review is pleased to bring you information regarding the upcoming ABA Conference on Business Acquisition Negotiations:
When
November 01 – 02, 2012
Where
The National Law Review recently published an article regarding CON Applications written by Pamela A. Scott of Poyner Spruill LLP:
The North Carolina Court of Appeals recently made crystal clear that a certificate-of-need (CON) applicant’s submission of additional information after its application has been filed does not constitute a forbidden amendment, unless it materially changes the proposal set forth in the application. The CON regulation prohibiting amendments of applications has been around for more than 30 years, but it has rarely been interpreted by our appellate courts. The no-amendment rule is often a basis for attack against CON applicants that submit any supplemental information after their applications have been filed and deemed complete by the CON Section. In a recent opinion in WakeMed v. N.C. DHHS (COA11-1558), the Court of Appeals rejected the notion that the CON Section’s consideration of any additional information submitted by an applicant after an application is deemed complete constitutes a prohibited amendment requiring disapproval of the application. Instead, the court held that the proper test is whether the additional information materially changed representations made in the application.
At issue in the WakeMed appeal were competitive applications for operating rooms in Wake County and the Division of Health Service Regulation’s decision to award a CON for three ambulatory ORs to Holly Springs Surgery Center (HSSC), a subsidiary of Novant Health, Inc. Rex Hospital, Inc. d/b/a Rex Healthcare (Rex), whose competing application was denied, argued that HSSC’s application should not have been approved because it was impermissibly amended after being filed and deemed complete. Rex’s argument hinged on HSSC’s submission of several subsections of the application and a letter of support from an orthopedic physician practice as attachments to its responsive comments during the CON review approximately two months after the application was deemed complete by the CON Section. Both the subsections and support letter were inadvertently omitted from the application when it was originally filed.
The Court of Appeals disagreed with Rex’s theory that the test for whether a CON application has been amended should be whether the agency “considered” information provided after the application was filed. Instead, the court harkened to the single case in which the court previously held that an application had been impermissibly amended. In that 1996 Presbyterian-Orthopedic Hospital v. N.C. DHHS case, the Court of Appeals had concluded that the CON applicant made a material amendment to its application when it changed the management company that would oversee the operations of its proposed facility, because all the applicant’s logistical and financial data was based upon using the original management company. Consistent with this prior decision, in WakeMed the court ruled that because the answers to the questions in the missing application subsections were found elsewhere in the HSSC application as originally submitted, and because the physician letter of support was specifically referenced in the original application — including identification of the surgeons who signed the letter – the additional information submitted by HSSC did not materially amend the application. The court also noted the testimony of the CON Section chief and project analyst that the approval of the HSSC application was not based upon the additional materials filed.
It is always the best practice to ensure a CON application is complete and contains all necessary information before it is filed with the CON Section. However, inadvertent omissions and other mistakes in the content of applications do happen. The Court of Appeals’ recent analysis of this issue sheds light for long term care providers on the type of additional information that can be submitted regarding a CON application under review, without crossing the amendment line. It should also help CON applicants ward off specious and hyper technical challenges by opponents that are grounded in nothing other than the mere submission of supplemental or clarifying information after an application is filed.
© 2012 Poyner Spruill LLP
The National Law Review‘s media partner, Retail Industry Leaders Association‘s Deborah R. White, recently submitted this article for your review:
The Retail Industry Leaders Association (RILA) and Retail Litigation Center (RLC) are hosting their 3rd annual Retail Law Conference from November 7-9, 2012 at the Westin Galleria in Dallas, Texas. The Retail Law Conference is an educational event for retail legal executives to discuss the latest issues affecting the retail industry. More than 125 retail corporate lawyers and compliance executives have already registered to attend the event, which includes sessions covering the broad range of issues that retail corporate counsel face every day.
This year’s conference includes a special focus on compliance, providing retail executives with the opportunity to network, collaborate, and learn how to build stronger compliance programs and how to utilize them in an increasingly global context. The conference will feature compliance-oriented general and breakout sessions that are led by a variety of professionals including government regulators, corporate retail compliance officers, and outside legal experts. Compliance session topics include:
In addition to the conference sessions on compliance, retail Chief Compliance Officers and compliance specialists are invited to attend a pre-conference meeting to discuss trends and meet colleagues who are grappling with the same issues. We will also discuss the unique needs of the retail compliance community and vehicles that RILA can develop to serve them.
Attendees at this year’s Retail Law Conference will be able to earn up to 14 hours of Continuing Legal Education (CLE) credits, including at least 1 hour in legal ethics.
