On May 28, 2013, the US Food and Drug Administration (FDA) published a draft guidance entitled "Contract Manufacturing Arrangements for Drugs: Quality Agreements."1 The draft guidance describes FDA’s views on defining, establishing and documenting the responsibilities of parties that are involved in the contract manufacturing of drugs that are subject to current good manufacturing practice (cGMP) requirements ...
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 ...
Battered women who fear for their safety, mothers unable to support their children, dysfunctional families in need. A reality for many women is the presence of domestic violence in their lives. This situation, although occurring in all social and economic levels, is much more obvious and has more serious consequences in low-income communities ...
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 ...
The Office of the Civil Registrar General of the National Statistics Office promulgated Administrative Order No. 1 series of 2012 (AO 1) on October 24, 2012. The AO implements the provisions of Republic Act 10172, the amendatory law to Republic Act 9048, and supplements Administrative Order 1 series of 2001, which, in turn, implements RA 9048. Both statutes provide a means of correcting erroneous entries in the civil registry without need of judicial action ...
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 ...
Traditional knowledge (TK), for example folklore, is a controversial issue and we’ve written about it before. The government feels that TK should be legally protected, and that this should be achieved through amendments to the intellectual property (IP) statutes. The IP community has no issue with TK being protected, but it’s not very comfortable with this being done through IP legislation ...
The New Amparo Law-On April 2, 2013, the Amparo Law, Regulatory of Articles 103 and 107 of the Constitution of the United Mexican Estates, was published in the Official Gazette of the Federation. This new law broadens the constitutional defense of rights, since more individuals can have access to the amparo actions ...
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 ...
On March 22, 2013, the Department of Homeland Security ("DHS") announced that it will submit to the Office of Management and Budget ("OMB") a new Information Collection Request ("ICR") related to the implementation of the Chemical Facility Anti-Terrorism Standards ("CFATS") Personnel Surety Program ("PSP"). DHS is soliciting comments during a 60-day public comment period (which ends May 21, 2013) prior to the submission of the ICR to OMB ...
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 ...
In 2008 the government introduced important intellectual property (IP) legislation. The Intellectual Property Rights from Publicly Financed Research and Development Act 51 of 2008 - which only came into force on 2 August 2010 – governs the ownership and exploitation of IP which flows from publicly financed research and development (R&D) ...
On March 8, 2013, U.S. Citizenship and Immigration Services released a new version of Form I-9 with a revision date of 03/08/2013. Employers are required to use the new Form I-9 no later than May 7, 2013, for all new hires and rehires, as well as to re-verify an employee’s identity and continued employment eligibility. Employers are not required to replace prior I-9 forms that were used before May 7, 2013 ...
In 2008 the government introduced important intellectual property (IP) legislation. The Intellectual Property Rights from Publicly Financed Research and DevelopmentAct 51 of 2008 - which only came into force on 2 August 2010– governs the ownership and exploitation of IP which flows from publicly financed research and development (R&D) ...
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) ...
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 ...
The Comelec promulgated Resolution No. 9615 on 15 January 2013. This Resolution implements the provisions of Republic Act No. 9006, more popularly known as the Fair Election Act, for purposes of the 2013 national and local mid-term elections ...
