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Practice Industry: Crossborder Trade & Investment, Healthcare & Pharmaceuticals, Life Sciences
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Last week, a federal jury in South Carolina found that Tuomey Healthcare System, Inc. violated the Stark Law and the False Claims Act by submitting false claims for reimbursement to the United States, resulting in $39 million in damages to the government. United States ex rel. Drakeford v. Tuomey Healthcare Sys., Inc., No. 3:05-2858-MBS (D.S.C. May 8, 2013) ...

Waller | May 2013

Following a month-long retrial, a South Carolina jury has concluded that Tuomey Healthcare System, Inc. (Tuomey) violated the Stark Law and the False Claims Act by illegally paying referring physicians. The jury found that Tuomey’s compensation arrangements with referring physicians were impermissible under the Stark Law, resulting in almost 22,000 false claims and more than $39 million in overpayments ...

Waller | May 2013

Today the HHS Office of Inspector General (OIG) issued an Updated Special Advisory Opinion addressing the recommended scope and frequency of exclusion checks of employees and contractors. The Advisory Opinion provides important and practical guidance to assist healthcare providers seeking to protect their businesses against the risk of employing or contracting with excluded individuals and entities ...

PLMJ | May 2013

Increase in the Registration of Patents, Trademarks and Property Protected by Copyright - The various plans and the range of measures included in them that have been described have produced practical results, particularly an increase in the applications for registration of patents, trademarks and protection by copyright, specifically for property such as software. In terms of applications for patents registered in 2011, China came in first place above the USA and Japan ...

Haynes and Boone, LLP | April 2013

On April 17, 2013, the Health and Human Services Office of Inspector General (OIG) released an Updated Provider Self-Disclosure Protocol (SDP), which replaces the original SDP published in 1998. The SDP is used by providers and suppliers to voluntarily disclose violations of the fraud and abuse laws. According to the OIG, it has received more than 800 disclosures since the SDP’s inception, resulting in more than $280 million in recoveries ...

ENSafrica | April 2013

EN-GB" lang=EN-GB>It was reported recently that bikers had protested outside Parliament about proposed measures which would have the effect of making life verydifficult for those businesses who are involved in the parallel importation of motorbikes ...

ENSafrica | April 2013

The decision of the Indian Supreme Court to deny Novartis’s application for patent protection for an improved version of its patented Glivec drug – the culmination of a seven-year battle - has certainly made the headlines. There are a number of reasons for this. First, Glivec is a well-known drug – described by some as a ‘wonder drug’ – that’s used to combat cancer, including  leukaemia and gastro-intestinal cancer ...

Veirano Advogados | April 2013

Mobilizing the Money: A New Investment Program President Dilma Rousseff has launched an ambitious investment program in infrastructure, transport, logistics, and energy that will cost US$ 235 billion. The president and the entire government have been mobilized in the search for these investments, from domestic, foreign, public, and private sources ...

Waller | April 2013

In a significant victory for healthcare providers, the Sixth Circuit Court of Appeals on Monday overturned an $11.1 million False Claims Act (FCA) judgment against Atlanta-based medical imaging company MedQuest Associates, Inc. and three of its Nashville, Tennessee-area imaging facilities. The Court held that the company did not violate the FCA by failing to comply with Medicare supervising-physician regulations or Medicare enrollment regulations following a change of ownership ...

Haynes and Boone, LLP | April 2013

The Obama Administration has announced its intention of entering into negotiations with the European Union (“EU”) for a Transatlantic Trade and Investment Partnership (“TTIP”) aimed at achieving a substantial increase in transatlantic trade and investment between the world’s two largest economies. In the Federal Register of April 1, the United States Trade Representative solicited comments from the public with respect to U.S. negotiating objectives ...

PLMJ | April 2013

On 28 January 2013 the «Diário da República» (official gazette) published a set of measures1 - that came into force the following day - to improve and streamline the special scheme2 for granting a Portuguese ‘investment residence permit’ (“IRP”) to foreign nationals to enable them to make certain investments in the country ...

Waller | March 2013

Over the past decade, the Office of Inspector General for the Department of Health and Human Services (OIG) has repeatedly emphasized the important role that Boards of Directors play in ensuring that their organizations have robust and effective compliance programs. At the same time, state and federal law enforcement agencies have shown a growing interest in the role of healthcare Boards when they investigate organizations for suspected healthcare fraud ...

Haynes and Boone, LLP | March 2013

The Committee on Foreign Investment in the United States The Exon-Florio Amendment to the 1988 U.S. Defense Production Act established the Committee on Foreign Investment in the United States ("CFIUS"). CFIUS is composed of representatives of several U.S. Government agencies, including the Departments of Treasury, State, Defense, Homeland Security, Labor and Commerce ...

A March 7, 2013 piece on Morning Edition, the morning news program from National Public Radio, raised a lot of questions. “In A Grain Of Golden Rice, A World Of Controversy Over GMO Foods” told the story of golden rice, a beautiful yellow rice enhanced with beta-carotene, or Vitamin A. This rice was ostensibly developed to be grown in developing countries, where foods high in Vitamin A either are uncommon or are expensive ...

Haynes and Boone, LLP | March 2013

A federal court jury in Illinois found that nursing home operator Momence Meadows fraudulently billed Medicare and Medicaid for “worthless services” and falsely certified compliance with health care laws and regulations, resulting in $28 million in damages to the government. United States ex rel. Absher v. Momence Meadows Nursing Ctr., Inc., No. 2:04-cv-02289 (C.D. Ill. Feb. 8, 2013) ...

Waller | March 2013

Historically there has been relatively little enforcement focus on the typical physician-ownership model used by many ambulatory surgery centers (ASCs).  A qui tam lawsuit filed recently against an ambulatory surgery center company based in Nashville, however, indicates that qui tam relators are leaving no stone unturned as they look for cases. Although the federal government has declined to intervene in U.S. ex. rel Thomas Reed Simmons v. Meridian Surgical Partners, et ...

It took thirteen years, four months, and five days of heated debates and passionate protests before the country’s first reproductive health law was passed. Four days shy of Christmas last year, President Aquino finally signed the 24-page bill into law. It is now Republic Act No. 10354 or The Responsible Parenthood and Reproductive Health Act of 2012 (RH Law). The passing of the RH Law, however, does by no means close this chapter of Philippine history ...

The Philippine Supreme Court has issued a decision that may have a significant impact on how local nationality requirements (i.e., constitutional and statutory provisions requiring minimum Filipino ownership in certain industries) must be construed and applied. Enterprises such as telecommunications, media, advertising and land ownership are subject to such nationality requirements.The case of Gamboa v. Teves, et al. (G.R. No ...

Waller | February 2013

A new program taking effect in March provides hospitals with a new option to secure funds for financing acquisitions and refinancing debt. On February 5, 2013, the Office of Hospital Facilities published a new rule that will enable qualifying hospitals to finance their acquisitions and/or refinance their existing debt with FHA insurance even if the hospitals do not have FHA-insured mortgages ...

Makarim & Taira S. | February 2013

Sixteen years since the enactment of Law No. 7 of 1996 regarding Food (“the 1996 Food Law”), the Government issued the new Food Law (ie Law No. 18 of 2012) (“Food Law”) on 18 October 2012, two days after World Food Day. The Food Law replaces The 1996 Food Law. The Food Law covers three significant areas which were not governed by the 1996 Food Law, ie imports of food; the halal requirement; and the establishment of a new non-ministerial agency in-charge of food matters ...

Makarim & Taira S. | February 2013

After lengthy discussions among regulators and politicians on ownership of commercial banks, Bank Indonesia issued its Regulation No. 14/8/PBI/2012 regarding Ownership of Shares in Commercial Banks (“BI Regulation No. 14”) which came into effect on 13 July 2012.In general, BI Regulation No. 14 provides rules that restrict ownership of commercial banks by individuals or corporations either on an individual or joint basis. BI Regulation No ...

Haynes and Boone, LLP | January 2013

Under the Patient Protection and Affordable Care Act (“PPACA”), an employer that employs an average of at least 50 full-time and full-time equivalent employees (a “Large Employer”) during 2013 may be subject to a penalty in 2014 if the Large Employer fails to offer “minimum essential coverage” to all but 5 percent (or, if greater, five) of its full-time employees (“No Coverage Penalty”) ...

Haynes and Boone, LLP | January 2013

The long awaited Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Regulation amendments (the “Changes”) to incorporate the changes made by Health Information Technologyfor Economic and Clinical Health (HITECH) in 2009 as part of the American Recovery and Reinvestment Act and by the Genetic Information Nondiscrimination Act (“GINA”) were recently released ...

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