After the Netherlands, Slovakia, and the UK, it is now France’s turn to impose Sunshine-like obligations on the pharmaceutical industry. Soon, similar obligations will apply to all EU countries, after EFPIA, the European trade association for the pharmaceutical industry, adopts a code of conduct on disclosure of transfers of value between pharmaceutical companies and health care professionals or institutions ...
The Budget. The 83rd Texas Legislative Session convened on January 8th with news of a better-than-anticipated revenue estimate, an unusually high number of new and second-term legislators, and less controversy and fanfare than observers have come to expect at the start of the biennial, 140-day process. In mid-March, only days before the bill became due, lawmakers passed and the Governor signed legislation to fill the $4 ...
Earlier this month, the United States Department of Justice (“DOJ”) filed a suit against Vitas Hospice Services, L.L.C. and its subsidiary entities (“Vitas”) alleging that Vitas submitted false claims for hospice services which were excessive, unnecessary, or not provided, and also alleging that Vitas admitted patients to hospice who were not terminally ill ...
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) ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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) ...
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 ...
Shipment in Indonesia is regulated by the Indonesian Commercial Code (“ICC”) and Law No. 17 of 2008 (the “Shipping Act”), which spawned a variety of implementing regulations. After 2008 a package of new implementing regulations to the Shipping Act sought to regulate a broad spectrum of water transportation aspects, including: • Port Affairs (Government Regulation No ...
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 ...
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 ...
As you may well be aware of, the Manta Multipurpose Deepwater Terminal Concession project was awarded to Hutchison by November 17, 2006. I personally assisted Hutchison in the process, from the time immediately after tendering its offer to the time the concession agreement was executed. then, Hutchison took its own path and, eventually, the relationship between the Port Authority and Hutchison was over ...
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”) ...
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 ...
The wait is over. On January 17, 2013, the Department of Health and Human Services’ ("HHS’") Office for Civil Rights ("OCR") released its long-anticipated megarule ("Omnibus Rule") amending the HIPAA Privacy, Security, Breach Notification and Enforcement Rules. These amendments implement and expand on the requirements of the Health Information Technology for Economic and Clinical Health ("HITECH") Act and the Genetic Information Nondiscrimination Act of 2008 ...
Legislators filed bills before the official start date of the 83rd Texas Legislative Session; many of the bills already filed address healthcare issues. 1. The Budget. Texas legislative leaders recently approved a self-imposed budget cap for the 2014-2015 biennium based on a conservative estimate of growth in the state’s economy, holding lawmakers to not more than a 10 ...
Omnibus HIPAA Rule, Including Significant Breach Notification Rule Changes, Released by HHS - The long-awaited final rule modifying the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules (the Rule) was released on January 17, 2013 by the Department of Health and Human Services (HHS) ...
A small nonprofit hospice in Idaho became the first healthcare provider to settle a potential violation of the HIPAA Security Rule affecting fewer than 500 individuals. On January 2, 2013, Hospice of North Idaho agreed to a settlement in the amount of $50,000 with the Department of Health and Human Services, Office of Civil Rights (OCR) following an investigation relating to a 2010 breach involving a stolen, unencrypted laptop containing patient information ...
The U.S. District Court for the Eastern District of Virginia recently overturned the United States Patent & Trademark Office ("USPTO") interpretation of the patent term adjustment ("PTA") statute in Exelixis, Inc. v. Kappos. Similar to Wyeth v. Kappos, where a previous USPTO interpretation of the PTA statute was overturned, the Exelixis decision promises to add months and even years to the patent term of many patents ...