Header graphic for print
Focus on Regulation

Monthly Archives: June 2012

EU State aid rules: Tax measures can and must be assessed under the market investor principle

On June 5, 2012, the EU Court of Justice ruled that tax measures may avoid the qualification of State aid if the State acts as a private investor, i.e. if the State’s decision is based on economic evaluations comparable to those which, in the circumstances, a rational private investor in a situation as close as… Continue Reading

Supreme Court Issues Long-Awaited Health Reform Decision: Upholds Entire Law, but Imposes Certain Restrictions on Medicaid Expansion

In the most closely-watched decision of its 2012 term, Chief Justice Roberts delivered the opinion for a majority of a divided Supreme Court today upholding the individual mandate in the Affordable Care Act (ACA).  The vote was 5-to-4.  While the Court also upheld the Medicaid expansion, it narrowly read the federal government’s power to terminate… Continue Reading

Congress Clarifies the Custom Device Exemption, But Questions Remain

Congress has passed The Food and Drug Administration Safety and Innovation Act (FDASIA) reauthorizing existing FDA user fee programs and extending these programs to generic drugs and biosimilars, which is now headed to the President’s desk to be signed into law. In addition to authorizing user fee programs that are expected to cover 60% of the agency’s 2013‒2017… Continue Reading

EU Agrees to First Energy Efficiency Directive

 Authored by Christopher Norton and Camilla Shires, Hogan Lovells London Office Against a background of growing dependency on energy imports and the recognition that the EU is currently not on track to meet its 20% energy saving target by 2020, European policymakers have finally reached agreement on the first-ever Energy Efficiency Directive.  The Directive is… Continue Reading

Wanted: Organizations Willing to test ACO Advanced Payment Model

It’s not too late for organizations interested in becoming an Advanced Payment Model Accountable Care Organization (ACO).  The Centers for Medicare and Medicaid Services (CMS) has announced it will accept a third round of applications to test the Advanced Payment Model for ACOs participating in the Medicare Shared Savings Program. As part of CMS’s larger… Continue Reading

Is Inherent Reasonableness Coming Back to CMS?

Six and a half years after CMS promulgated regulations for the use of “inherent reasonableness” authority to alter a payment rate, CMS is considering applying this little used authority to Medicare payment levels for non-mail order diabetic testing supplies. In 2011, a competitive bidding process for the mail order equivalent of such supplies resulted in an… Continue Reading

The IRS Proposes Additional Requirements for Charitable Hospitals

The Internal Revenue Service (IRS) issued a Notice of Proposed Rulemaking (NPRM) setting forth proposed regulations regarding the requirements for charitable hospital organizations implemented under section 501(r) of the Internal Revenue Code (IRC), added by the Patient Protection and Affordable Care Act (PPACA).  This NPRM, published in the Federal Register on June 26, 2012, builds… Continue Reading

Eleventh Circuit Sides With Artist In Dispute Over the Depiction of the University of Alabama’s Uniforms

Does a university have the right to stop an artist from selling paintings and other expressive items that depict the school’s football uniforms?  In a recent case involving the University of Alabama, the Eleventh Circuit Court of Appeals’ answer was no.  The court held that a painter’s First Amendment right of expression outweighed the university’s… Continue Reading

Hogan Lovells Hosts Roundtable on India Women and Water

Hogan Lovells recently hosted a roundtable discussion entitled, “Water and Women: Village Development in Rural India”, which brought together non-governmental organizations, federal agencies, and corporations to exchange ideas and experiences in improving access to water in rural India. The roundtable was initiated by the Institute of Rural Research and Development (IRRAD) and the Seghal Family… Continue Reading

CMS Proposes New Standards for Medicaid and CHIP Income Eligibility

CMS released a solicitation for public input on June 21, 2012, seeking comments on two potential methodologies for converting current state Medicaid and Children’s Health Insurance Program (CHIP) net income eligibility standards to equivalent modified adjusted gross income (MAGI) standards in accordance with section 2002 of the Patient Protection and Affordable Care Act (PPACA). Starting… Continue Reading

NET Power announces pressurized CO2 power generation system

A revolutionary new power generation system, developed by NET Power LLC, continues to draw top-notch partners and investors including Toshiba Corp, The Shaw Group Inc., and Exelon Corp.  The technology NET Power developed utilizes a pressurized stream of carbon dioxide (CO2) to drive a turbine to generate electricity. After the electricity is generated, the CO2… Continue Reading

Supreme Court Rules Agencies Must Honor Contract Obligations Even if “Subject to the Availability of Appropriations”

Co-Authored by Agnes P. Dover, Partner and Director of Hogan Lovells’ Government Contracts Practice In the only government contract case it considered this term, Salazar, Secretary of the Interior, et al. v. Ramah Navajo Chapter et al., the Supreme Court of the United States addressed the question of whether a federal agency is excused from paying… Continue Reading

Mexico Implements “Ventanilla Unica” Paperless Environment for Import and Export Operations

Mexico will no longer allow the filing of import or export documentation or declarations in paper form.   Effective June 1, 2012, Mexican importers, exporters and their brokers are required to use the Single Window for Foreign Trade (“Ventanilla Unica de Comercio Exterior”) to submit shipment information and related supporting documentation (e.g., certificates of origin and permits).  The… Continue Reading

Breaking decisions from the Supreme Court: Term in review

On Tuesday afternoon, three of Hogan Lovells’ Appellate practice partners will provide an analysis of some of the key decisions that will impact businesses as the Supreme Court concludes its current term. Neal Katyal, former Acting Solicitor General of the United States and Appellate practice Co-Director, Cate Stetson, Co-Director of our Appellate practice; and Chris… Continue Reading

NTIA to Focus on Mobile App Transparency in First Privacy Multistakeholder Meeting

The National Telecommunications & Information Administration(NTIA) has announced that it will hold the first meeting in its long-awaited privacy  multistakeholder process on July 12, 2012.  According to NTIA, the goal will be “to develop a code of conduct to provide transparency in how companies providing applications and interactive services for mobile devices handle personal data.” For our analysis and summary of… Continue Reading

EU expands Syria sanctions to luxury products

 The Council of the European Union has adopted Regulation 509-2012 containing implementing rules for sanctions against Syria, effecting a ban on exports of luxury goods and of additional dual-use goods, which came into force on 17 June 2012. The regulation identifies a number of luxury goods, as well as dual-use goods such as chemicals, pathogens and equipment… Continue Reading

Annual Quota of H-1B Visas Reached

USCIS has announced that, as of 11 June 2012, the agency has received enough petitions for H-1B visas that are subject to the annual quota for Fiscal Year 2013 (covering the Oct. 1, 2012–Sept. 30, 2013 period).  The quota was met much earlier than in the last two years.  This will impact all U.S. employers who… Continue Reading

FWS Decides Not to List Dunes Sagebrush Lizard as Endangered Species

In deciding to withdraw a proposed rule to list the dunes sagebrush lizard as an endangered species, the Fish and Wildlife Service (FWS) has signaled yet again its growing preference for landowner cooperation in the development and implementation of conservation strategies. According to state and industry representatives, listing of the three-inch lizard, which occupies a… Continue Reading

GAO Issues Briefing on Delayed Baggage and Options for Compensating Airline Passengers

 The General Accountability Office (“GAO”) issued a briefing late last week on delayed baggage in the airline industry and options for compensating passengers. GAO Briefing.  The FAA Modernization and Reform Act of 2012 required such a briefing from the Comptroller General.  In preparing its briefing, the GAO interviewed DOT officials, airline representatives, and consumer organization representatives, analyzed… Continue Reading

Hogan Lovells Publishes Client Alert on DoD’s Cyber Security Information Sharing Program

On June 13, 2012, Hogan Lovells Partners Thomas L. McGovern and Todd R. Overman, both with our Government Contracts Practice, published a Client Alert entitled, “DOD Voluntary Cyber Security Program Requirements May Limit Participation Opportunities For Some Government Contractors.”  The Client Alert discusses the practical implications for government contractors of the Department of Defense’s interim… Continue Reading

FCC Proposes Changes on How to Pay for Universal Service as Program Shifts to Broadband

How telephone companies and others contribute to the multi-billion dollar Universal Service Fund (“USF”) is going to change, and comments regarding the proposed new rules are due by July 9, 2012.  The FCC proposed changes that could expand the pool of services that have to contribute to USF, which subsidizes communications services for high-cost rural… Continue Reading

FDA’s Changing Culture: What Food Companies Need to Know

The Food and Drug Administration (FDA) is undergoing a major culture change, and nowhere is that impact being felt more than in the food industry.  While visibly preparing new regulations to implement the Food Safety Modernization Act (FSMA), the agency has quietly become much more inspection-oriented and enforcement-minded, even under its historic authorities.  Here is… Continue Reading

D.C. Circuit Addresses Department of Education “Program Integrity” Rules

On June 5 the U.S. Court of Appeals for the District of Columbia Circuit issued a decision that invalidates parts of the Department of Education’s “program integrity” regulations but for the most part upholds them.  The challenged regulations address incentive payments to student recruiters, misrepresentation in marketing and advertising, and state authorization.  Last July, a… Continue Reading