http://www.fulbright.com/publications Publications from the International Law Firm of Fulbright & Jaworski L.L.P. 30 http://www.fulbright.com/img/logos/logo_RSS.gif http://www.fulbright.com/publications 144 48 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6154&site_id=494&detail=yes On March 21, Health and Human Services Secretary Kathleen Sebelius announced that Medicare-enrolled seniors have saved over $6.1 billion on prescription drugs since 2010 due to the Affordable Care Act (ACA).  The ACA includes a provision for gradually closing the donut hole (the gap period in Medicare coverage during which beneficiaries must pay the full cost of the prescriptions out of pocket).  This process began in 2010, with Medicare providing beneficiaries who reached the donut hole a one-time check for $250.  Starting in 2011, CMS has begun phasing in discounts and ... Fri, 29 Mar 2013 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6154&site_id=494 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6155&site_id=494&detail=yes On March 27, 2013, the U.S. Supreme Court issued its long-awaited opinion in Comcast Corp. v. Behrend , addressing the quality of proof needed to satisfy Federal Rule of Civil Procedure 23's rigorous requirements for certifying a class.  The federal circuit courts have taken diverse approaches as to whether and under what circumstances an expert's testimony can be used to satisfy the requirement that common issues predominate.  Some have refused to consider expert challenges at the certification stage, others have permitted such challenges, while still others have ... Thu, 28 Mar 2013 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6155&site_id=494 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6153&site_id=494&detail=yes On March 18, Senators Thune (D-S.D.) and Klobuchar (D.Minn.) re-introduced a bipartisan bill that would expand the use of home health care telehealth technology by Medicare.  The hope is that this technology can help reduce hospital readmissions, particularly in rural and underserved communities.  Additionally, the technology may be used to help individuals with declining help stay in their homes longer, potentially reducing costs associated with nursing homes and long-term care facilities. Non-invasive telehealth technology can be used to monitor a patient's ... Thu, 28 Mar 2013 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6153&site_id=494 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6152&site_id=494&detail=yes The Department of Health and Human Services Office of Inspector General (OIG) has issued updated guidelines to evaluate state false claims act legislation based on amendments to the federal False Claims Act (FCA).  To keep financial incentives, states will need to update their laws to reflect changes in the FCA, which would create expanded liability for providers and more opportunities for whistleblowers to allege violations of state false claims acts.  Effective March 15, the updated guidelines apply 2009 and 2010 amendments to the False Claims Act made by (1) the Fraud ... Wed, 27 Mar 2013 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6152&site_id=494 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6151&site_id=494&detail=yes This week, members of the House Energy and Commerce Committee criticized the Food and Drug Administration ("FDA") for failing to finalize regulations and guidance governing the use of mobile healthcare applications.  Specifically, congressmen and members of industry said that by failing to issue these regulations, the FDA has left medical professionals and developers of mobile applications  uncertain as to how to legally proceed with technology. In July 2011, the FDA released draft guidance and requested public comments on how the agency should regulate ... Tue, 26 Mar 2013 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6151&site_id=494 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6150&site_id=494&detail=yes On March 20, 2013, Richard Gilfillan, MD, Director of the Center for Medicare and Medicaid Innovation ("CMMI") appeared before the Senate Committee on Finance to discuss the status of various CMMI healthcare transformation initiatives.  Ranking Member Orrin Hatch (R –UT) expressed a concern that CMMI initiatives lack focus and that "more work needs to be done to make coordination more systemic. . . . CMMI would function best if it would pick a few initiatives – such as accountable care organizations . . . or bundled ... Mon, 25 Mar 2013 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6150&site_id=494 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6148&site_id=494&detail=yes The UK Competition Commission (the "CC") has recently published an annotated issues statement as part of its market investigation into the UK private healthcare market. The investigation was begun in April 2012 after the UK Office of Fair Trading raised concerns that a number of features of the market for privately funded healthcare services in the UK prevent, restrict or distort competition. The CC's annotated issues statement sets out seven theories of harm to frame the investigation: Market power of hospital operators in certain local areas: The CC ... Fri, 22 Mar 2013 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6148&site_id=494 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6131&site_id=494&detail=yes FDA says sequester means fewer inspections and increased risk to consumers FDA releases international food safety capacity-building plan Court strikes down New York soda ban – appeal to be heard in June USDA publishes new COOL rule in Federal Register Due to new studies, FDA reopens comment period for rule on BSE FDA releases materials from public meetings regarding proposed rules under the FSMA FDA releases corrections to proposed rules Monster reclassifies its products as beverages FDA ... Fri, 22 Mar 2013 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6131&site_id=494 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6132&site_id=494&detail=yes Although efforts to prepare for Sunshine Act reporting often focus on payments and transfers of value, physician ownership and investment interests and the interests of their family members (including a physician's granddaughter's husband) must also be tracked and reported.  Both applicable manufacturers and applicable group purchasing organizations (GPOs) must report both direct and indirect ownership or investment interests.  The Centers for Medicare & Medicaid Services (CMS) has limited some aspects of reporting through its final rule, 78 Fed. Reg. 9458 ... Thu, 21 Mar 2013 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6132&site_id=494 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6137&site_id=494&detail=yes In a unanimous decision issued on March 19, 2013, the Supreme Court held that class action plaintiffs cannot avoid federal jurisdiction under the Class Action Fairness Act ("CAFA") by stipulating that the total class damages will be less than $5 million. The decision is styled Standard Fire Insurance Co. v. Knowles , No. 11-1450, and is a victory for defendants that have struggled to remove large-scale class actions that Congress intended to be heard in federal court. A number of plaintiffs have avoided removal to federal court by promising to limit damages for all the ... Thu, 21 Mar 2013 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6137&site_id=494 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6138&site_id=494&detail=yes Who Owns Global IP: Securing IP Ownership Rights Around the World Your client generates intellectual property domestically and perhaps in different parts of the world. Regardless of where it's created, your client wants to own the rights to that intellectual property everywhere it does business throughout the world. How do you ensure your client actually owns its IP around the globe, especially when rules and requirements for proving ownership vary? Download the presentation materials in the attached PDF Thu, 21 Mar 2013 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6138&site_id=494 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6140&site_id=494&detail=yes In a landmark ruling on March 19th, the Supreme Court held in Kirtsaeng v. John Wiley & Sons, Inc., No. 11-697, that the "first sale" doctrine – which permits lawfully acquired copies of copyrighted works to be resold by their owners – also applies to works manufactured overseas. By holding that the first sale doctrine applies to goods manufactured abroad as well as those manufactured in the United States, the Court reversed a Second Circuit decision upholding a jury determination that Petitioner Supap Kirtsaeng was liable for willful copyright ... Thu, 21 Mar 2013 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6140&site_id=494 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6149&site_id=494&detail=yes California landlords and property owners have an important date to highlight on their calendars: July 1. That's when new disclosure requirements for ADA surveys and some buildings' energy usage histories go into effect. The coincidental date arises out of two separate laws. Under the first, Senate Bill 1186, landlords of commercial property must state in their leases whether the premises have been inspected for handicapped accessibility by a Certified Access Specialist (commonly abbreviated as "CASp") and if so, those findings. The second, Assembly Bill 1103 ... Thu, 21 Mar 2013 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6149&site_id=494 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6146&site_id=494&detail=yes In 1988, Hill Dermaceuticals filed a successful new drug application with the FDA for a corticosteroid.  The approval was for three separate products – body oil, scalp oil, and ear oil drops.  In 2011, the FDA approved three abbreviated new drug applications ("ANDAs") for generic version of Hill's three products.  Hill subsequently sued the FDA, "arguing that the FDA's approval of [the generic] products was arbitrary and capricious" under the Administrative Procedure Act ("APA").  The district court granted summary judgment ... Thu, 21 Mar 2013 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6146&site_id=494 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6147&site_id=494&detail=yes While the Supreme Court upheld the Patient Protection and Affordable Care Act ("PPACA") individual mandate in a decision this past June, various groups have attempted to challenge the controversial provision on other grounds and these challenges are now making their way through the federal courts.  Plaintiffs before both the U.S. District Court for the District of Columbia and the U.S. Court of Appeals for the Fourth Circuit recently argued that both the individual mandate and the employer mandate are unconstitutional under the Origination Clause of the U.S. Constitution ... Thu, 21 Mar 2013 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6147&site_id=494 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6145&site_id=494&detail=yes On Wednesday, March 13, 2013, the Senate voted to reject an amendment that would have defunded President Obama's Affordable Care Act in a 45-52 vote.  Senator Ted Cruz (R-Texas) had introduced the amendment as part of the $984 billion spending continuing resolution currently being reviewed by Congress.  The amendment would have eliminated funding for the Affordable Care Act until the economy grew at a minimum rate of 3-4 percent.  The vote represents the 35 th time Republicans in Congress have attempted to repeal or eliminate funding for the Affordable Care Act ... Wed, 20 Mar 2013 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6145&site_id=494 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6130&site_id=494&detail=yes Who Owns Global IP: Securing IP Ownership Rights Around the World Your client generates intellectual property domestically and perhaps in different parts of the world. Regardless of where it's created, your client wants to own the rights to that intellectual property everywhere it does business throughout the world. How do you ensure your client actually owns its IP around the globe, especially when rules and requirements for proving ownership vary? Join us for an informative overview of patent, trademark, copyright and trade secret ownership in the U.S. and ... Wed, 20 Mar 2013 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6130&site_id=494 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6143&site_id=494&detail=yes On March 14, Members Allyson Schwartz (D-PA) and Aaron Schock (R-ILL) introduced in the U.S. House of Representatives the Training Tomorrow's Doctors Today Act, which if enacted into law, would increase graduate medical education funding for 15,000 new medical residency positions over the next five years (3,000 new slots each year).  Hospitals could apply for the new resident slots through one of two pools, with a limit of 75 new slots per hospital under both pools.  According to a press release issued by Members Schwartz and Schock, the 75 new resident limit per hospital ... Tue, 19 Mar 2013 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6143&site_id=494 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6144&site_id=494&detail=yes As we reported last week, the Medicare Payment Advisory Commission ("MedPAC") on March 7 considered the issue of higher Medicare payments for services performed in hospital outpatient departments compared to physician offices.  MedPAC staff presented a report entitled "Addressing Medicare payment differences across settings:  Ambulatory care services."  The staffers described that Medicare spending on evaluation and management services will increase $1.2 billion per year and beneficiary cost sharing will increase by $310 by the year 2021, if the current ... Tue, 19 Mar 2013 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6144&site_id=494 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6141&site_id=494&detail=yes Earlier this month, the U.S. Food and Drug Administration ("FDA") issued final guidance to address financial disclosure by clinical investigators.  The final guidance document, entitled, "Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators," contains nonbinding recommendations to assist clinical investigators, industry, and agency staff in interpreting and complying with the financial disclosure regulation, set forth at 21 C.F.R. part 54, which requires applicants who submit a marketing application for a ... Mon, 18 Mar 2013 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6141&site_id=494 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6142&site_id=494&detail=yes On March 13, 2013, the Centers for Medicare and Medicaid Services ("CMS") issued a proposed rule that would enable hospitals to receive Medicare Part B outpatient payments when Part A payments are denied on the grounds that beneficiaries should have been treated as hospital outpatients rather than admitted as inpatients.  Under the proposed rule, when a Medicare Part A claim for hospital inpatient services is denied because the inpatient admission was deemed not to be reasonable and necessary, or when a hospital determines after a beneficiary is discharged that his/her ... Mon, 18 Mar 2013 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6142&site_id=494 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6092&site_id=494&detail=yes In its October 2012 and November 2012 public meetings, the Medicare Payment Advisory Commission ("MedPAC") debated and eventually recommended making Medicare payment rates for practitioner evaluation and management ("E&M") services equal regardless whether performed in hospital outpatient departments or in freestanding physician clinics.  During a public meeting yesterday, March 7, 2013, MedPAC considered the broader issue of Medicare payments being higher for services provided in hospital outpatient departments and other provider-based entities compared to ... Fri, 15 Mar 2013 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6092&site_id=494 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6093&site_id=494&detail=yes On 5 th March 2013 it was announced that the government would redraft the National Health Service (Procurement, Patient Choice and Competition) Regulations 2013 (SI 2013/257) (the "Regulations") which were due to come into force in England on 1 April 2013.  The Regulations are adopted pursuant to section 75 of the Health and Social Care Act 2012, the purpose of which is to ensure that, in commissioning NHS healthcare services, the relevant bodies adhere to good procurement practice; promote and protect patient choice, and do not engage in anti-competitive ... Fri, 15 Mar 2013 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6093&site_id=494 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6089&site_id=494&detail=yes In a notice of extension published in the March 7, 2013 Federal Register, the Centers for Medicare and Medicaid Services described that changes to the payment adjustment for low-volume hospitals and to Medicare dependent hospitals under the hospital inpatient prospective payment are effective for discharges during federal fiscal year 2013 (October 1, 2012 through September 30, 2012).  Congress mandated these payment changes in the American Taxpayer Relief Act of 2012, the so-called "fiscal cliff law," sections 605 and 606.  Low-volume hospitals will have to reapply ... Thu, 14 Mar 2013 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6089&site_id=494 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6091&site_id=494&detail=yes In a decision dated March 5, 2013, the U.S. Court of Appeals for the District of Columbia Circuit held that the plaintiff teaching hospital could properly revise its count of graduate medical education ("GME") full-time equivalent ("FTE") residents for Medicare payment purposes outside the three-year period provided in the Medicare reopening regulations.  In the Balanced Budget Act of 1997, Congress limited the number of FTE residents hospitals can count for Medicare GME and indirect medical education ("IME") payment purposes to 1996 (base period) ... Thu, 14 Mar 2013 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6091&site_id=494 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6097&site_id=494&detail=yes The Texas courts are taking a hard line against obtaining direct and unfettered access to your adversary's computer systems (or images of those systems). If you want such access, be prepared to overcome some significant hurdles.    In its recent In re Pinnacle Engineering decision, the Court of Appeals for the First District of Texas found that the trial court had abused its discretion in ordering access to forensic copies of the Defendants' computers and network server hard drives.  In re Pinnacle Engineering , Inc., 01-12-01105-CV (Tex. App.-Houston [1st ... Thu, 14 Mar 2013 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6097&site_id=494 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6096&site_id=494&detail=yes During President Obama's first term, the Office of Federal Contract Compliance Programs (OFCCP) was extremely active, including initiating aggressive compliance audits resulting in the demand and collection of higher penalties for non-compliance. During President Obama's second term, many anticipate even greater OFCCP activity, including more audits, more regulations, and even stronger enforcement efforts. The panel on this seminar includes a corporate Director of Employment Practices who has significant experience with OFCCP audits, a former Assistant District ... Wed, 13 Mar 2013 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6096&site_id=494 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6087&site_id=494&detail=yes On March 1, 2013, the U.S. Department of Health and Human Services ("HHS") issued a final rule in which HHS will provide assistance to insurers of high-risk individuals in an effort to stabilize premiums in the individual health insurance market.  The final rule establishes risk adjustment methodology to be used in states participating in a federally-run health insurance exchange.  This methodology is intended to reduce health insurer incentives to avoid coverage of high-risk individuals.  "The goal of the Affordable Care Act risk adjustment program is to ... Wed, 13 Mar 2013 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6087&site_id=494 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6088&site_id=494&detail=yes Co-located long-term care hospitals ("LTCHs"), that is, LTCHs that are located in the same building or on the same campus as another hospital-level provider, are required to report their co-located status to their respective claims processing contractors.  Health and Human Services Office of the Inspector General ("OIG") requires this reporting because of concerns that co-location "creates incentives for providers to make decisions about admitting and discharging patients on the basis of maximizing Medicare payments."  As part of an ... Wed, 13 Mar 2013 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6088&site_id=494 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6085&site_id=494&detail=yes This week, the Food and Drug Administration ("FDA") issued food guidance titled "Guidance for Industry:  What You Need to Know About Administrative Detention of Foods Small Entity Compliance Guide."  Section 207 of the Food Safety Modernization Act ("FSMA"), signed into law in January 2011, authorizes the FDA to order the administrative detention of food if the agency has reason to believe that the particular food article is misbranded or adulterated, thus preventing the detained food from reaching consumers.  This guidance provides ... Tue, 12 Mar 2013 http://www.fulbright.com//index.cfm?fuseaction=publications.detail&pub_id=6085&site_id=494