In its judgment of 19 January 2012 (case no. 08332/11), the Southern Central Administrative Court, decided that INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P. (the national authority for medicines and healthcare products), is obliged to issue a certificate of subsidisation of the price of a medicine even when the person requesting the issue of the certificate was not the person who applied for the subsidy ...
The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services has begun the pilot phase of HIPAA privacy and security audits of health care providers, health insurers and health care clearinghouses (“covered entities”) to assess HIPAA compliance efforts. Up to 150 covered entities will be subject to the initial audits, to be conducted by KPMG, LLP, the OCR audit contractor ...
Only two days after the government’s announcement that it recovered a record-breaking $4.1 billion from its healthcare fraud enforcement efforts in 2011, the Centers for Medicare and Medicaid Services (CMS) published a draft regulation in today’s Federal Register implementing the Affordable Care Act’s (ACA) 60-day overpayment report and return provision ...
The Centers for Medicare and Medicaid Services (CMS) on February 16, 2012 proposed rules1 implementing Section 6402(a) of the Affordable Care Act,2 requiring persons to report and return Medicare overpayments by the later of 60 days after an overpayment is identified or the date any corresponding cost report is due. Twice in the past, CMS had proposed rules requiring the return of Medicare overpayments, but did not finalize the regulations ...
Healthcare providers and other HIPAA covered entities have until Wednesday, February 29, 2012 to submit notice of breaches of unsecured Protected Health Information which affected fewer than 500 individuals during 2011. Notice must be submitted electronically to the Secretary of Health & Human Services, and separate forms are required for each data breach occurring in the course of the calendar year ...
The Stage 2 Meaningful Use requirements proposed last week by CMS as part of the Medicare and Medicaid incentive programs to expand the use of Electronic Health Record (EHRs) maintain the same core and menu structure as the Stage 1 criteria. The proposed rule, however, gives providers an additional year, until 2014, to implement Stage 2 criteria ...
Law no.11/2012 of 8 March establishes new rules for prescription and dispensing of medicines. Prescriptions for medicines must now include the International Nonproprietary Name (INN) of the active substance,its pharmaceutical form, the dosage, the presentation and the posology. The prescription may also include a trade name by brand or indication of the name of the holder of the marketing authorisation ...
After three days of historic oral arguments before the U.S. Supreme Court, the fate of the Affordable Care Act (ACA), the momentous 2010 health reform law, is uncertain, given robust questioning of the ability of Congress to force individuals to purchase health insurance ...
The U.S. Fourth Circuit Court of Appeals has reversed a $44 million judgment against Tuomey Hospital in Sumter, South Carolina that arose from Tuomey’s employment arrangements with physicians that allegedly violated the federal Stark Law.1 The Stark Law prohibits hospitals from submitting claims to Medicare for designated health services that were referred by physicians with whom the hospital has a financial relationship, unless the relationship fits within an exception ...
In Greek mythology, Prometheus stole fire from Zeus to give to mankind. It seems that Zeus is now reclaiming some of that fire in the guise of Mayo Collaborative Servs. v. Prometheus Labs., Inc., No. 10-1150 (U.S. Mar. 20, 2012), the Supreme Court’s latest decision addressing patent-eligible subject matter. But a practical analysis of Prometheus reveals strategies one can use in drafting patent claims to keep those claims burning ...
Three recent decisions bolster a generic manufacturer’s ability to challenge Orange Book listings and obtain ANDA approval through section viii “carve-outs.” In Caraco v. Novo Nordisk1 the U.S. Supreme Court unanimously held Caraco could use the Hatch-Waxman’s counterclaim provision to correct Novo’s overbroad use code. In AstraZeneca v. Apotex, the U.S ...
New amendments to the Regulation on Health Conformity of Dietetic Products have entered into force on 28 May 2012. Here are some of the most significant changes that are prescribed by these amendments to the Regulation. As a reminder, this is a regulation that introduced the obligation of the registration of dietetic products (including supplements) in July 2010, and is a regulation that regulates the issues of labelling and the composition of these products in details ...
The provision of gifts and hospitality to public officials has recently been the subject of a number of news stories in the Serbian media, covering not only the official reports on the variety of protocol gifts received by the high ranking officials from the leaders of other countries, but also the alleged corruption affairs involving the potential bribing of various lower-level officials by companies and individuals seeking an unfair advantage in the market ...
As a consequence of a number of copyright rulings from the CJEU, the Swedish threshold of originality requirement is being superseded by an EU originality criterion. In this article, Henrik Bengtsson, IP expert at Delphi in Stockholm, reports on the development and the possible impact on the harmonisation of Swedish copyright law ...
On January 24, 2011 the Attorney General of the Federal Republic of Brazil signed a document restricting the powers of ANVISA (Brazil’s regulatorybody) in the examination of pharmaceutical applications, giving the rights to the Brazilian PTO to do so without any interference of ANVISA. The dispute between ANVISA and the Brazilian PTO in the examination of pharmaceutical applications had apparently been solved ...
During the ITMA Asia + CITMA 2012 in Shanghai (12th - 16th June 2012), an exhibition of worldwide fame for textile machinery manufacturers, the Belgian company Picanol NV has at a Shanghai court successfully applied for and enforced interim injunctions to stop design patent infringements against three Chinese manufacturers, Guangdong Fengkai Machinery Co., Ltd., Shandong Liaocheng Youjia Textile Machinery Co., Ltd. and Zhejiang Wanli Textile and Machinery Co ...
The Federal Trade Commission’s increased focus on the antitrust implications of healthcare mergers and acquisitions has been widely publicized. While scrutiny has largely been directed toward hospital and health system transactions, a recent case in Nevada indicates that the FTC is now taking an interest in relatively small provider combinations in highly concentrated markets ...
On September 17, 2012, the Department of Health and Human Services (“HHS”) announced a $1.5 million settlement with the Massachusetts Eye and Ear Infirmary and Massachusetts Eye and Ear Associates Inc. (“MEEI”) for potential violations of the HIPAA Security Rule ...
Currently a large part of politicians, economists and lawyers are working hard to ensure that a recent Lithuania’s bank bankruptcy story would not repeat itself. Sometimes people still associate the term “bank” with instability, possibility to lose something or lack of transparent governing. Maybe this is the reason why there are no biobanks in Lithuanian which are widespread in the EU and other countries of the world ...
On 15 October 2012, the Federal Government announced the appointment of an expert panel to review pharmaceutical patents in Australia (Review). The Review will focus particularly on the extension of term provisions in Chapter 6, Part 3 of the Patents Act 1990 (Cth). Those provisions currently allow the extension of pharmaceutical patents up to five years beyond their standard 20-year term ...
The General Medical Council has issued definitive guidance on doctors' duties when they fear a child in their care is suffering from abuse. The GMC's 2012 Guidance on Child Protection came into effect on 3 September 2012 after a two-year working group - chaired by a senior family court Judge, the Right Honourable Lord Justice Thorpe - listened to evidence given by child protection experts ...
Skilled nursing facilities (SNFs) billed one-quarter of all claims in error in 2009 – resulting in $1.5 billionin inappropriate Medicare payments – according to a report released by the Department of Health and Human Services’ Office of Inspector General (OIG) on November 9, 2012. The OIG noted that the majority of the inappropriate claims were upcoded, and many involved claims for so-called “ultrahigh therapy ...
On November 15, 2012, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) issued a report titled “Personal Care Services: Trends, Vulnerabilities, and Recommendations for Improvement,” which included a response from the Centers for Medicare and Medicaid Services (CMS) ...
The rapid growth of the hospice industry has attracted the attention of Congress and federal and state healthcare regulatory and enforcement agencies. The Patient Protection and Affordable Care Act (the “ACA”), signed into law by President Obama on March 23, 2010, included several provisions aimed at hospice providers ...
On November 26, 2012, the Department of Health and Human Services’ Office of Civil Rights (“OCR”) published guidance on the two methods for de-identifying protected health information (“PHI”) in accordance with the HIPAA Privacy Rule ...
