Legal Updates

CMS Proposes to Withdraw Regulations on Average Manufacturer Price Determination, Multiple Source Drug Definition, and Medicaid Federal Upper Limits

by Wendy C. Goldstein, Kathleen A. Peterson, Benjamin S. Martin, and Constance A. Wilkinson

On September 3, 2010, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule withdrawing regulations governing the determination of “Average Manufacturer Price” (“AMP”), the definition of “Multiple Source Drug,” and the application of federal upper reimbursement limits (“FULs”) for Multiple Source Drugs (the “Proposed Rule”). This withdrawal would impact the applicable regulations finalized by CMS in 2007 and 2008 but would leave intact other sections of the 2007 regulations, including, for example, the “Best Price” provisions and certain “definitions” (including the definition of “bona fide service fee”). Comments may be submitted to CMS until 5:00 p.m. EDT on October 4, 2010. We recommend that organizations consider commenting on the impact of the withdrawn regulations, as well as on the open items that have not been addressed under the recent “health reform” legislation. 

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The ‘Retirement’ of the Default Retirement Age?

The Employment Equality (Age) Regulations were introduced in 2006. One of the most significant changes introduced by the regulations was that of a Default Retirement Age (“DRA”) which made it possible for an employer to fairly dismiss an employee on the ground of retirement once they reached the age of 65. So long as the employer complied with the statutory procedure, any dismissal on the ground of retirement would be fair.

This law has been under constant scrutiny since its introduction, even leading to Age Concern raising a legal action against the UK Government which was pursued all the way to the European Court of Justice. Whilst the (then Labour) Government successfully resisted this action, they did give an indication that the DRA would be reviewed in 2011. This is a nettle which has been firmly grasped by the new coalition Government who have now announced plans to phase out the DRA by 1 October 2011.

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HEALTH REFORM: CMS Proposes to Withdraw Regulations on Average Manufacturer Price Determination, Multiple Source Drug Definition, and Medicaid Federal Upper Limits

On September 3, 2010, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule withdrawing regulations governing the determination of “Average Manufacturer Price” (“AMP”), the definition of “Multiple Source Drug,” and the application of federal upper reimbursement limits (“FULs”) for Multiple Source Drugs (the “Proposed Rule”).[1] This withdrawal would impact the applicable regulations finalized by CMS in 2007 and 2008[2] but would leave intact other sections of the 2007 regulations, including, for example, the “Best Price” provisions and certain “definitions” (including the definition of “bona fide service fee”). Comments may be submitted to CMS until 5:00 p.m. EDT on October 4, 2010. We recommend that organizations consider commenting on the impact of the withdrawn regulations, as well as on the open items that have not been addressed under the recent “health reform” legislation.

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Take Action to Appoint a ‘Human’ Director before 1 October 2010

Is your board made up exclusively of corporate directors?

If so, then you have been making use of the transitional provisions under the Companies Act 2006. Under the Act all companies must have at least one natural person (otherwise, a ‘human’) as a director, although if your company was already incorporated before the new law came into effect then a grace period applies until 1 October 2010.

Failure to appoint a natural person by the end of this month could result in hefty fines being levied against both the company and the defaulting directors of up to £5,000 with the possibility of additional daily fines accruing for continuing default.

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Multi-Million Dollar Trade Secret Heist Results In Federal Criminal Plea

Co-authored by Christie O. Tate.

In the latest example of a significant international trade secret theft resulting in a federal criminal prosecution, chemist David Yen Lee recently pleaded guilty in federal court in Chicago to “knowingly and without authorization” possessing one or more trade secrets of his former employer Valspar Corporation (“Valspar”) with intent to convert them “to the economic benefit of someone other than the owner.” Valspar is an international company with offices in Illinois and elsewhere that manufactures and sells paint and coating products in the United States and internationally. Lee worked for Valspar as a Technical Director from approximately 2006 until March 2009, when he departed for Nippon Paint (“Nippon”), a Valspar competitor.

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New Workshops Help Women Strengthen Their Leadership Skills

If you are in the New York City area and would like to strengthen your leadership skills and network with other women professionals, the Athena Leadership Lab at Barnard College (Columbia University’s Liberal Arts College for Women), in Manhattan is offering hands-on courses designed to “teach women the practical elements of leadership – from the art of negotiation to effective public speaking, from financial fluency to management savvy.” You don’t need to be a current or past student of Barnard College to enroll.

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Immigration Alert: August 2010

Emergency Border Security Supplemental Appropriations Act, Which Includes Targeted Visa Fee Hikes, Becomes Law

Customs and Border Protection Announces Interim Final Rule Increasing ESTA Fee

Department of Homeland Security Amends Rules Governing Electronic Signature/Storage of Forms I-9

State Department Issues Final Rule Regarding J-1 Trainees and Interns

August 13, 2010, H-1B Cap Count

Smartsoft Agrees to Pay $1 Million to Settle H-1B Visa Allegations with Department of Labor

DOS Issues September 2010 Visa Bulletin

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Third Circuit Case Explores Nooks and Crannies of Trade Secret Misappropriation Under Pennsylvania Law

A July 27, 2010 decision by the United States Court of Appeals for the Third Circuit, in Bimbo Bakeries USA, Inc. v. Botticella, No. 10-1510, upheld an injunction preventing a senior executive from commencing employment at Hostess Brands, Inc., a bakery rival to the plaintiff Bimbo. The decision is notable in that the Court enjoined Mr. Botticella’s employment, in the absence of any non-competition agreement, on the basis that there was a “substantial likelihood,” but not an “inevitability,” that Mr. Botticella would disclose or use Bimbo’s trade secrets in the course of his planned employment at Hostess.

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Societies of Limited Responsibilities and Individual Enterprises of Limited Responsibilities

Societies of Limited Responsibilities

The societies of Limited Responsibilities are those formed by two or more persons by contributions of all partners, who don’t respond personally of the social debts. It is our personal believe that this will be the most commonly used form of company.
Particular Characteristics
  • Number of partners: minimum two (2) and maximum of fifty (50)
  • Social denomination: a fantasy name can be used or a trade name that will have to be preceded or followed by the words “Society of Limited Responsibilities” or the initials “SRL”. If this indication is omitted the partners will be jointly responsible in front of third parties.
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Bloomberg Article Examines Whistleblower Awards and Protections under the Dodd-Frank Wall Street Reform and Consumer Protection Act

In the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank), Congress has crafted an array of bounty awards and whistleblower protections broadly affecting securities, commodities and futures, and consumer financial products firms and those associated with them. Although there was an opportunity to create incentives promoting internal reporting in aid of corporate compliance programs and to rationalize whistleblowing with standardized definitions, procedures and remedies, Congress went in different directions. The result is a set of whistleblower inducements that may frustrate attainment of corporate compliance objectives by driving whistleblowers outside the organization and an enigmatic patchwork of whistleblower protections laden with internal variations that must be mastered.

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