BackgroundFollowing much anticipation on the part of health care industry members, CMS released its long-awaited final rule on the Physician Payment Sunshine Act in February 2013, supplying clarification and guidance on new financial disclosure requirements governing pharmaceutical and medical device manufacturers. The rule includes extensive and potentially time-consuming mandates for drug and device companies, including reporting of annual payments to physicians and teaching hospitals ...
On 13 June 2013, the Supreme Court of the United States handed down its unanimous decision in the ongoing case of Association for Molecular Pathology et al v Myriad Genetics, Inc. et al 12-398, 569 US __ (2013). This case is the first brought in the US directly challenging the patentability of human genes and for that reason is extremely important to any entity involved in the biotechnology industry which relies on human genetics research as part of innovation strategy ...
Never has there been a more controversial law in the past decade than the Reproductive Health Law (“RH Law”). After a long and contentious battle in Congress, the law was finally passed. But the fervent opposition by the so-called Pro-life groups (chief among them the Catholic Church) endures. Four days after the approval of the law’s Implementing Rules and Regulations (“IRR”), the Supreme Court on March 19, 2013, halted its implementation, issuing a 120-day status quo ante order ...
Denmark has a large life science sector, including a number of biotech and pharmaceutical companies and research activities. The sector is highly regulated and covered by extensive and complicated statutory requirements, executive orders and ethical standards. Denmark has incorporated most of the EU regulation and Danish law is thus to a large extent in conformity with the general EU regulation and practice of, for example, the European Medicines Agency (‘EMA’) ...
Physicians in Texas can receive up to $160,000 for the repayment of medical school loan debt through a state program that received a significant increase in funding earlier this year. To be eligible, physicians need to apply by Nov. 30, 2013 and agree to provide four consecutive years of service in a federally designated Health Professional Shortage Area ...
In the innovativeness of its economy, Poland ranks 4th from last in the European Union, but greater support is planned for highly innovative projects that show promise for implementation and commercialisation in Poland. At a session of the Polish Parliament’s Innovation and New Technology Committee on 19 June 2013, the Ministry of Regional Development presented the guidelines for operational programmes Smart Growth 2014–2020 and IT & Telecommunications 2014–2020 ...
In a statement issued by the National Regulatory Agency, Control and Surveillance (ARCSA), drugs that are sold in Ecuador must have labels stating the words 'generic', otherwise it can not be marketed as of January 24, 2014 ...
On October 18, 2013, the Centers for Medicare & Medicaid Services (CMS) published Survey & Certification Letter 14-01-NM, which clarified the obligations of a skilled nursing facility (SNF) or nursing facility (NF) (collectively “nursing homes”) to provide cardiopulmonary resuscitation, or CPR, to its residents ...
Starting in January 2014, everyone will be required to purchase health insurance. If you are someone whose company already provides you with insurance, you can probably skip this article. But if you are elderly, purchase your insurance privately, or are one of the 24.2 percent of Texans without health insurance, you might want to read on ...
The 83rd Texas Legislature passed legislation to simplify the process by which physicians supervise and delegate to Physician Assistants (PAs) and Advance Practice Registered Nurses (APRNs). This article summarizes the rules recently adopted by the Texas Medical Board (TMB) to implement SB 406 (83R) ...
On Thursday, November 7, 2013, the United States Food and Drug Administration (FDA) announced measures to definitively eliminate all the artificial trans fats from processed products in the United States. The purpose of the proposal, which is released for public comments for a 60-day period, is to remove trans fats from the “generally recognized as safe” (“GRAS”) category, which would allow these products to be commonly used in food products ...
Physician-owned distributorships (PODs) and other physician-owned entities (POEs) have emerged as a favored vehicle to reduce costs, but the popularity of PODs and POEs has led to increased scrutiny by federal regulators. In June 2011, the United States Senate called on the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) and Centers for Medicare & Medicaid Services to investigate the proliferation of PODs and corresponding utilization practices ...
The boom days of the 1990s were driven by the relentless rise of our burgeoning services sector. The conspicuous consumption of the day was fuelled by a belief that Britain was at the forefront of the post industrial revolution. The demise of UK manufacturing was little more than collateral damage. Yet wind forward to today and how different the picture looks as UK manufacturing leads us towards a long awaited recovery ...
As in past years, chemical, pharmaceutical and biotechnology patent cases in 2013 offered a combination of the predictable and the unpredictable. On the predictable end of the spectrum, the US Supreme Court offered no surprises ...
St. Luke’s Health System’s 2012 acquisition of Saltzer Medical Group, Idaho’s largest independent multi-specialty physician practice group, violated federal and state antitrust laws according to a U.S. District Court holding issued on Friday, January 24, 2014. The Court ordered divestiture of the practice. The FTC and the Idaho Attorney General filed the Complaint seeking to block the sale on March 12, 2013. In response, St ...
The Affordable Care Act, in a largely overlooked provision, bestowed broad powers on the Centers for Medicare and Medicaid Services (CMS) to impose a moratorium on the enrollment of new Medicare or Medicaid providers, including whole categories of providers in certain geographic locations ...
CMS recently announced yet another delay to the full implementation of “two midnight rule,” which revises its longstanding guidance to hospitals and physicians relating to when hospital inpatient admissions are deemed to be reasonable and necessary for payment under Medicare Part A. Specifically, this latest “delay” is the result of CMS’s extension of the “Probe & Educate Period,” a period of partial non-enforcement for the two midnight rule requirements, until September 30, 2014 ...
Horizon 2020 is the new EU Framework Programme offering more than €70bn funding for Research and Innovation initiatives over the period 2014 to 2020 and covering every stage of the innovation process from research to market uptake. Ivan Waide and Kate Keith, IP & Technology lawyers at A&L Goodbody, take a closer look at the programme, including opportunities available to Northern Ireland businesses and research organisations ...
In one of the few decisions of its kind, the UK High Court recently assessed the damages to be paid to a generic pharmaceutical company under a cross-undertaking in damages. While some aspects of the decision are specific to the UK pharmaceutical reimbursement scheme, the judgment will be a useful reference point for parties involved in similar litigation in Australia ...
As you no doubt already know, the Pharmaceutical Industry in Argentina is a strictly controlled industry. Said control is held by the ANMAT Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) and it spreads from the first authorisation of a laboratory to act as such in the country, moving through the authorisations to commercialise products, up to pharmacovigilance of products that have already been commercialised ...
On April 1, 2014, the Superior Court issued an interesting decision respecting consent to care1. The Quebec City CHU petitioned the Superior Court in order to be authorized to provide care for a 60‑day period to a patient despite the refusal of her parents. On March 14, the 22 years old patient suffered cardiac arrest following an intravenous drug overdose ...
Regional governments in Sweden are increasingly looking to leverage their purchasing power in order to secure discounts and rebates on the list prices of branded drugs. However, as noted by Elizabeth Eklund, Partner at leading commercial law firm Delphi, such agreements risk running foul of both Swedish and European Union (EU) law ...
The healthcare industry will have to wait for a court to answer the question of whether the United States Federal Trade Commission (the “FTC”) has authority to regulate data security practices of entities covered by the Health Insurance Portability and Accountability Act (“HIPAA”). On Monday, a federal district judge dismissed LabMD, Inc.’s case without reaching the merits, declining to disrupt the underlying administrative proceeding ...
