The Patient-Centered Outcomes Research Institute (PCORI) released research funding announcements on May 22, 2012 for $96 million in grant funding to support clinical comparative effectiveness research (CER). These PCORI funding announcements (PFAs) will support four of the five areas of focus outlined in PCORI’s National Priorities for Research and Research Agenda, including: Assessing different prevention,… Continue Reading
Monthly Archives: May 2012
FERC Enforcement Staff Presents “State of the Markets” Report
At FERC’s April open meeting, staff from the Office of Enforcement (OE) presented its 2011 State of the Markets Report. The report represents OE’s annual assessment of the natural gas, electric, and other energy markets, but does not necessarily reflect the views of FERC, its Chairman, or individual Commissioners According to OE, 2011 saw reduced… Continue Reading
CFTC’s Rulemaking Schedule Released
CFTC Commissioner Scott D. O’Malia recently released a copy of the agency’s draft rulemaking schedule for 2012 (below and available here).
FERC seeks help on how to treat generator interconnection lines
At its April open meeting, FERC issued a notice of inquiry (NOI) seeking comments on whether, and how, FERC should revise its current policy concerning priority rights and open access with regard to certain generator interconnection facilities. The NOI responds to concerns expressed in conjunction with a March 2011 technical conference on priority rights to… Continue Reading
When a de novo rehearing is not enough
A recent judicial review case against the UK Financial Services Authority (“FSA“) has emphasised that judicial review will be available even where there is a statutory right of appeal or review, if that statutory mechanism does not provide a suitable and adequate remedy. Where the complaint is that the decision-maker has not given adequate reasons,… Continue Reading
Advisory Panel on Hospital Outpatient Payment Meeting Dates Set
The Centers for Medicare & Medicaid Services (CMS) issued a Federal Register notice on May 25, 2012 announcing that the second semi-annual meeting of the Advisory Panel on Hospital Outpatient Payment (Panel) will take place on the following dates: Monday, August 27, 2012, 1 p.m. to 5 p.m. EDT Tuesday, August 28, 2012, 9 a.m…. Continue Reading
DOT Issues Guidance on Use of the Term “Free” in Air Fare Advertisements and Disclosure of Consumer Costs in Award Travel
The U.S. DOT this week issued guidance related to the use of the term “free” in air fare advertising and the disclosure of costs associated with award travel. DOT Guidance Free. The DOT is giving entities covered by this guidance sixty days to modify their promotional material in accordance with this guidance. The DOT announced… Continue Reading
Despite the Fixings and Garnish Atop FDA’s Proposed Risk Classification Scheme, the Obesity Device Industry Appears to Have Been Served a Potentially More Restrictive Diet
FDA recenlty held a general issues advisory panel meeting to present a proposed risk classification scheme designed to allow the agency to stratify medical devices intended to treat obesity into varying risk levels. Each risk level would be tied to a specific efficacy endpoint, with higher endpoints required for higher risk devices and lower efficacy… Continue Reading
Ninth Circuit Suggests Flexibility in Type Size for Food Statements of Identity
While the Ninth Circuit’s recent ruling in POM Wonderful v. Coca-Cola has received attention for its holding on preemption, the decision provides interesting statements in the technical realm of the FDA’s type-size requirements for statements of identity in food labeling. The issue involved the statement of identity for Coca-Cola’s Pomegranate Blueberry Minute Maid drink, “Pomegranate… Continue Reading
Hogan Lovells White Paper on Government Access to Cloud Data Released in Brussels on 23 May Gains Wide Attention
As widely reported yesterday (in Computerworld, CSO Magazine, CIO Magazine, Network World, PC Advisor, Australian Techadvisor, IT World, among others) and as detailed in this article in PC World, Hogan Lovells yesterday released a White Paper at a Brussels conference organized by the Openforum Academy detailing a study about governmental access to data in the cloud. The paper was written… Continue Reading
Hogan Lovells Winnik Forum Panel Examines Challenges of Security and Data Privacy in the Cloud
Leading experts in telecommunications law and policy gathered recently at the Hogan Lovells Winnik International Telecommunications and Internet Forum in Washington, D.C., with privacy and data security issues coming up frequently in all of the discussions. In the final panel of the Forum, Hogan Lovells partner Winston Maxwell convened a panel of corporate practitioners that… Continue Reading
Agencies Focus on Hydraulic Fracturing: DOI Proposes Rule; EPA Publishes Guidance
Last week, the Bureau of Land Management (BLM) in the Department of the Interior (DOI) published a proposed rule that would revise certain regulations related to oil and gas development on public and Indian lands to add requirements for hydraulic fracturing operations. Comments on the proposed rule can be submitted to BLM until July 10,… Continue Reading
HHS and DOL Issue New Guidance on PPACA’s Summary of Benefits Requirements
HHS, together with the Department of Labor (DOL) released an FAQ regarding the Summary of Benefits Coverage (SBC) requirement imposed by the Patient Protection and Affordable Care Act (PPACA). This guidance builds on a Final Rule issued by the Departments on February 9, 2012, requiring health insurance issuers and group health plans to provide consumers… Continue Reading
IRS Issues Final Rule Regarding PPACA Tax Credits
Beginning in 2014, the Patient Protection and Affordable Care Act (PPACA) will make available new premium tax credits to help individuals and families afford health insurance coverage purchased through a health insurance exchange. On May 18, 2012, the Internal Revenue Service (IRS) issued final regulations regarding the availability of these tax credits for individuals who… Continue Reading
OSHA’s New Hazard Communication Standard
Chemical manufacturers, importers, and distributors and employers whose employees may be exposed to chemicals, need to be aware of OSHA’s recent revisions to its Hazard Communication Standard (HCS). Generally, the HCS requires that manufacturers and importers evaluate the hazards posed by chemicals they produce or import and then convey that information through labels and material… Continue Reading
Cultural fusion is unique enough for P-3 visa purposes
The U.S. Citizenship and Immigration Services’ (USCIS) Administrative Appeals Office issued a binding precedent decision addressing the term “culturally unique” in the context of visa petitions for performing artists and entertainers. The P-3 nonimmigrant visa classification applies to artists or entertainers who come to the United States temporarily to perform, teach, or coach under a… Continue Reading
Antero Resources Secures First Hydraulic Fracturing Toxic Tort Decision
Last week, in what is believed to be the first hydraulic fracturing tort case in the nation to reach a final decision, a Colorado trial court dismissed a personal injury and property damage lawsuit arising out of the drilling, hydraulic fracturing and development of natural gas wells in western Colorado. The lawsuit, Strudley v. Antero… Continue Reading
U.S. Easing of Burma Sanctions Announced by President Obama
President Obama announced on Thursday, May 17, that “the United States will ease its bans on the exportation of financial services and new investment in Burma.” In a related statement, Secretary of State Clinton indicated that “[t]he United States will issue a general license that will enable American businesses to invest across the economy, allow citizens access to… Continue Reading
FTC Requires Two “Gold-Standard” Studies in Sketchers Consent Decree
For the second time in eight months, the Federal Trade Commission (FTC) has obtained a multi-million dollar settlement as the price paid for alleged deceptive advertising of footwear promoted to help customers lose weight and strengthen muscles. The FTC announced its $40 million settlement with Sketchers earlier this week. According to the FTC, Sketchers incorrectly… Continue Reading
U.S. Department of Education Takes Steps to Curb Student-Aid Fraud
The U.S. Department of Education announced in the Federal Register that it plans to develop new regulations to prevent fraud and promote proper use of federal student financial aid funds awarded to distance education students. The May 1 announcement follows an earlier ED Office of the Inspector General report that described the increase in fraud-related incidents… Continue Reading
Congressional Report Highlights Recent Legislative Efforts Affecting Small Business Contractors, Amid New Proposed Regulations
Highlighting the continuing attention that Congress is giving to small business programs, the Congressional Research Service recently issued a report on “Federal Contracting and Subcontracting with Small Businesses: Issues in the 112th Congress” describing relevant actions taken by Members of the 112th Congress in this area. According to legislative attorneys Kate M. Manuel and Erika… Continue Reading
CMS Limits Reporting Requirements for Plans that Meet Medical Loss Ratio Standard
The Patient Protection and Affordable Care Act (PPACA) restricts the percent of premium dollars that health insurers may spend on administration, marketing and profits, the Medical Loss Ratio (MLR). The Centers for Medicare and Medicaid Services (CMS) has amended its regulations governing MLR standards for health insurers to create notice requirements for insurers who meet… Continue Reading
MEDCAC Discusses Future of Coverage with Evidence Development
The Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) held a day-long meeting on May 16, 2012 to discuss Coverage with Evidence Development (CED). This meeting is part of a larger effort by CMS to reconsider its use of CED, a Medicare policy in which an item or service that would not otherwise be considered… Continue Reading
HHS Releases Guidance on Federally Facilitated Exchanges and a Draft Blueprint for Approval of Exchanges
The Center for Consumer Information and Insurance Oversight (CCIIO) within the Centers for Medicare & Medicaid Services (CMS) released its long-awaited guidance regarding the federally facilitated exchanges (FFEs) on May 16, 2011. The Patient Protection and Affordable Care Act (PPACA) established the state-run health insurance exchange as a marketplace for individuals and small employers to… Continue Reading