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Haynes and Boone | July 2014

On July 16, 2014, the Sixth Circuit Court of Appeals confirmed that a “health care provider can bring the Medicare Secondary Payer Act’s (“MSP’s”) private cause of action against a non-group health plan that denies coverage for a reason besides Medicare eligibility.” In Michigan Spine & Brain Surgeons, PLLC v. State Farm Mutual Automobile Insurance Co., the Court clarified a key holding in its prior decision in Bio-Medical Applications of Tennessee, Inc. v ...

ENSafrica | July 2014

Food labelling in SA was given a much needed overhaul in 2011 with the introduction of new regulations relating to the labelling and advertising of foodstuffs, replacing outdated seventies-era regulations ...

This year marks the 30th anniversary of the passage of the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act (FD&C Act).  Considered to be one of the most successful pieces of legislation ever enacted, the Hatch-Waxman Amendments created the modern generic drug industry, which is responsible for dramatically increasing the availabilty of low-cost generic drugs and saving the U.S. healthcare system billions of dollars ...

Haynes and Boone | June 2014

As more states adopt anti-SLAPP legislation (i.e., Oklahoma’s passage this Spring and Nevada’s expansion of its anti-SLAPP statute last year), more federal courts must decide whether such laws create a substantive right which should be applied by the federal judiciary ...

Haynes and Boone | June 2014

The Supreme Court today ruled that Aereo’s system for transmitting over-the-air television broadcasts through the Internet violates copyright law. In a 6-3 decision, with Justice Breyer writing for the majority, the Court ruled that Aereo both “performs” the television broadcasts at issue and does so “publicly.” With these key issues decided, the Court essentially sounded a death knell for Aereo and a similar but unrelated company, FilmOn X ...

Haynes and Boone | May 2014

LabMD, Inc. renewed its argument that the FTC lacks authority to regulate the data security practices of HIPAA covered entities by appealing the dismissal of its case for lack of jurisdiction (see our coverage here) to the Eleventh Circuit. LabMD also filed an emergency motion seeking expedited briefing and requesting an order enjoining the administrative proceedings until the appellate court rules on the merits of its argument ...

Haynes and Boone | May 2014

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 ...

Delphi | May 2014

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 ...

Krogerus | May 2014

The Nils Svensson v Retriever Sverige AB decision addresses fundamental questions of copyright and Internet use.  In essence, the case addresses the question of whether hyperlinking to freely accessible content requires authorization.  The original plaintiffs of the Svensson case were Swedish journalists who wrote press articles that were published in the Goteborge-Posten newspaper and on its website, where they were freely accessible ...

Lavery Lawyers | April 2014

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 ...

Beccar Varela | March 2014

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 ...

MinterEllison | March 2014

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 ...

Waller | February 2014

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 ...

Waller | February 2014

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 ...

Waller | January 2014

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 ...

Haynes and Boone | December 2013

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 ...

Waller | November 2013

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) ...

Waller | November 2013

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 ...

Dykema | November 2013

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 ...

ALTIUS/Tiberghien | November 2013

Between 2007 and 2009 non-profit association Motor Sports Limes (MSL) hosted motocross races on a piece of land that it owned. It claimed to have taken all necessary safety precautions, including marking and securing circuit, for the races and associated events held there. According to MSL, only accredited photographers had to sign a contract with MSL, which included a clause stating that no commercial use of photos taken at the races could be made without MSL's prior consent ...

Bustamante Fabara | November 2013

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 ...

ALTIUS/Tiberghien | October 2013

SUMMARY: 1. Principles of Belgian Sports justice – 2. The relationship between ordinary justice and Sports justice – 3. The relevant NOC regulations and NOC judicial body – 4. The relevant football regulations and RBFA judicial bodies – 5. Other sports judicial bodies – 6. Clubs’ and players’ rights and obligations – 7. Dispute settlement – 8. ADR and interim relief – Conclusion Abstract:This article aims at providing an overview of sports justice in Belgium ...

PLMJ | October 2013

With the publication of Law no.74/2013 of 6 September a Court of Arbitration for Sport (CAS) was created in Portugal. The law will come into force 90 days after the setting up of the CAS, which will be based at the Portuguese Olympic Committee (POC). In an official communication dated 13 September the POC has already announced that it will respond positively to the mandate conferred on it to set up the CAS ...

Waller | September 2013

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 ...

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