The Centers for Medicare and Medicaid Services (CMS) has delayed the start date for data collection of payments made to physicians and teaching hospitals by drug and device manufacturers and group purchasing organizations (GPOs). Under the Physician Payment Sunshine Act (the “Sunshine Act”), such payments were to have been recorded beginning on January 1, 2012 ...
Kocián Šolc Balaštík kicked off the new year by helping complete a significant transaction: the sale of UG Air, an operator of duty free and fashion shops at the international airport in Prague, to Aelia Czech Republic s.r.o. KSB has provided legal advice to UNIMEX GROUP, a.s ...
On December 15, 2011 was published in the Official Journal of the Federation the decree by which they renovated and added various articles of the Federal law on protection to the consumer, which entered into force the day after its publication ...
In connection with the recent changes in legislation in the field of health, the Federal Commission for protection against health risks ("Cofepris") has taken various actions against the sale, distribution and advertising of the so-called "miracle products," which are distributed without scientific evidence to demonstrate its therapeutic properties ...
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 ...
Government guidance that suggests parent companies are unlikely to be snared by anti-bribery legislation that catches a subsidiary could lull businesses into a false sense of security. While it is unlikely that a subsidiary or joint venture partner operating independently and caught by the Bribery Act would make its parent liable, there is other legislation ready to catch the owner ...
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 ...
All fire insurance policies which cover a mortgaged immovable contain a clause dealing with the mortgage security (the “mortgage clause”). Financial institutions are familiar with this clause, which is considered as a separate contract from the insurance policy between the insurer and the mortgage creditor (the “creditor”) of the insured immovable ...
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 ...
Laverly follows the evolution of consumer law closely. Its specialized expertise in the fields of retailing and class actions has been confirmed many times by stakeholders in the milieu. Laverly makes it its duty to keep the business community informed about these matters by regularly publishing bulletins that deal with judicial and legislative developments that are likely to leave their mark and influence or even transform practices in the milieu ...
LAVERY follows the evolution of consumer law closely, its specialized expertise in the fields of retailing and class actions has been confirmed many times by stakeholders in the milieu ...
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 ...
