Practitioner Contributions

Drug and device manufacturers now have two procedural options when seeking formal approval and coverage for their products under Medicare. Under the traditional framework, the manufacturer first submits a new drug application to the Food & Drug Administration (FDA) for approval, then seeks a Medicare coverage determination from the Centers for Medicare & Medicaid Services [...]

On December 16, 2011, the Center for Consumer Information and Insurance Oversight (CCIIO) within the U.S. Department of Health and Human Services (HHS) issued an informal bulletin in which CCIIO outlined the approach that HHS plans to take in future federal regulations on the scope of the “essential health benefits.” Under the Affordable Care Act [...]

Over the last decade, the Supreme Court has shown an increased interest in patent law, taking up cases to answer fundamental questions such as the types of inventions eligible for patents in Bilski v. Kappos,1 the international reach of U.S. patents in Microsoft v. AT&T,2 and the deference that should be accorded issued patents at [...]

A fresh wave of legislation designed to foster and promote what its backers alternatively describe as responsible corporate citizenship or corporate social responsibility is cresting on U.S. businesses’ shores—and this time the aim is to combat the world’s most serious forms of labor exploitation. But unlike, say, the Foreign Corrupt Practices Act1 or the Dodd-Frank [...]

In November of last year, CAlifornians for Renewable Energy (CARE), a self-described “advocate for environmentally- and community-sensitive energy projects,” filed a lawsuit in Washington, D.C. federal court against the U.S. Department of Energy (DOE).1 They allege that up to $13.76 billion in alternative energy loan guarantees issued under Section 1705 (the Section 1705 Guarantees) of the Energy [...]

In its January 27, 2012 decision in Auriga Capital Corp. et al v. Gatz Properties LLC et al,1 the Delaware Court of Chancery reiterated well established law to the effect that, absent disclaimer or agreement to the contrary, limited liability company managers, officers and directors are charged with the equitable fiduciary duties of care and [...]

We are now two years out from the Supreme Court’s landmark decision, Citizens United v. Federal Election Comm’n,1 and well into the 2012 Presidential campaign. With two full years of experience, we now have a sense of what a world with unlimited personal and corporate giving looks like. We first provide brief background on the [...]

The Health Information Technology for Economic and Clinical Health Act (the HITECH Act) requires the U.S. Department of Health and Human Services (HHS) to provide for periodic audits to ensure that covered entities (health care providers, health plans and health care clearinghouses) and business associates are complying with the Health Insurance Portability and Accountability Act [...]

By the close of 2011, the Securities and Exchange Commission (SEC or Commission) was to have announced its decision regarding the adoption of international accounting standards for public company financial recordkeeping and reporting. But in December, it punted; SEC staff needed “a few additional months.”1 Someday, maybe soon, we’ll find out if the nearly decade-long [...]

Whistleblowers are “often the best source of information about waste, fraud, and abuse….” –President Barack Obama1 On December 15, 2011, the Consumer Financial Protection Bureau (Bureau or CFPB) issued a bulletin announcing its program to collect whistleblower information and law enforcement tips, stating that it “welcomes information from current or former employees of potential violators, [...]

On January 19, 2012, the IRS released temporary regulations (Temporary Regulations)1 and proposed regulations (Proposed Regulations)2 addressing the treatment of dividend equivalent payments for purposes of Section 871(m) of the Internal Revenue Code of 1986, as amended. These rules were highly anticipated by taxpayers who expected much needed guidance in the area of financial instruments, [...]

Securities, such as equity securities and debt securities, are usually held in book-entry form rather than traditional paper certificates. Securities in book-entry form are transferred through accounts kept by account providers (or a number of account providers) who act on behalf of an ultimate beneficial owner. The European Commission calls this the “holding chain,” and [...]

Well-publicized fraud scandals, including Bernie Madoff’s $20-billion Ponzi scheme and the Bayou Capital case, to mention only a few, have led to increased regulation of hedge funds.1 But hedge funds are more likely to have been the victims than the perpetrators of fraudulent schemes. Indeed, some of the largest creditors in the Madoff bankruptcy are [...]

College football has been riddled over the past year with scandals, rule violations, and the movement of teams from one conference to another. Media coverage has been quite negative, and the National Collegiate Athletic Association (NCAA) often is cast as the villain. Well-regarded economist Andy Schwarz has attacked the NCAA’s amateurism model.1 Taylor Branch, a [...]

In its decision in Ricci v. DeStefano, 129 S. Ct. 2658 (2009), the Supreme Court sought to resolve a conflict between the “twin pillars of Title VII,” the Act’s disparate-impact and disparate-treatment provisions. Ricci involved a promotional examination administered by the City of New Haven. After candidates took the examination, the City refused to certify [...]

A common and justifiable refrain met the Securities & Exchange Commission (SEC)’s new whistleblower rules providing significant incentives for employees to disclose Foreign Corrupt Practices Act (FCPA), among other, violations to the SEC—that the rules would challenge internal corporate compliance programs to prevent, detect, and remediate FCPA and other violations. The resulting advice has been [...]

The drumbeat of concern about cybersecurity is almost deafening today. And it should be. Many companies have been robbed blind, losing most of their competitive secrets to unseen intruders on their networks. Political leaders are demanding greater corporate disclosure of cyber-risks, and the Securities and Exchange Commission has released guidance1 that will force more detailed [...]

The perceived necessity of patent counsel opinions has plummeted ever since the Federal Circuit’s 2004 decision in Knorr-Bremse Systeme Fuer Nutzfahrzeuge GmbH v. Dana Corp.,1 which held that no adverse inference of willful infringement of a patent may be drawn either from the failure to obtain legal advice or the invocation of the attorney-client privilege [...]

The growing disagreement among federal courts over the timing for proving materiality in securities-fraud class actions highlights how unworkable the fraud-on-the-market (FOTM) inquiry currently is. In Basic Inc. v. Levinson,1 the U.S. Supreme Court held that a purported class of shareholders may take advantage of the FOTM presumption of reliance if it can make certain [...]

The America Invents Act (“AIA”), signed into law on September 16, 2011, presents new challenges and strategy considerations for inventors, and biotechnology and pharmaceutical companies that seek to obtain ― or preclude others from obtaining ― patents in the United States. Notably, beginning with patent applications having an effective filing date (“EFD”) on or after [...]