Just weeks into the new Administration, perhaps the only certain thing is that there will be uncertainty as the Administration makes its mark and works to fulfill campaign promises. Meanwhile, restaurant chains and food companies are trying to allocate resources to best address business priorities and hot legal issues ...
The Affordable Care Act (ACA) has been one of the most sweeping, and most divisive, pieces of legislation related to healthcare in a generation. More ink has been spilled over enactment, constitutionality, and repeal than any other government healthcare program. With the election of Donald Trump, and a Republican-controlled Congress, the repeal of the ACA is all but assured ...
The current EU regulations for medical devices and in vitro diagnostics are from the 1990s. The rapid technical developments in the health care system in recent years as well as the increased cross-border trade urgently require a modernization of the current legal framework. Now the adoption of new EU legislation is imminent. This article provides a brief overview of the planned content and the likely entry into force of the Regulations ...
As the American press focuses on the dismantling of the Affordable Care Act, the wheels have been set in motion to implement new health care legislation that enjoys strong bipartisan support. The 21st Century Cures Act (the “Act”), signed by President Obama on December 13, addresses a broad range of health care priorities, including drug innovation, biomedical research, and mental health reform ...
Under the Affordable Care Act (“ACA”), large employers (generally those with 50 or more full-time employees or full-time equivalents) must report annually to the IRS information about the health coverage offered to their full-time employees during the prior year. Employers also must provide copies of the reports to their full-time employees ...
Karanovic & Nikolic provided complete legal support to Affidea, a largest European medical service provider with respect to opening the first foreign hospital located in Belgrade. Our services consisted of extensive regulatory and corporate advice related to formation and start of operations of Affidea&s first hospital in Serbia. Affidea is one of the largest healthcare investors and operates over 180 Diagnostic and Cancer Treatment Centers in 15 countries across Europe ...
The recent Supreme Court of Appeal (“SCA”) case of Transnet v Total is important not only for those in the petroleum industry, but also, more generally, when it comes to aspects of competition and discrimination, as well as the impact of changes in the law on existing contracts and vested rights ...
The European Commission has opened an in-depth merger investigation into the planned acquisition of Cemex Croatia by Duna-Drava Cement ('DDC'). Registered in Hungary, DDC is jointly controlled by German construction material producers HeidelbergCement and Schwenk. DDC inter alia operates a cement plant in Kakanj, Bosnia and Herzegovina. Cemex Croatia, an arm of the international cement heavyweight Cemex, controls three cement plants in the Croatian coastal city of Split ...
The Internal Revenue Service (IRS) is ratcheting up surveillance of non-profit hospitals regarding their levels of community benefits and patient financial assistance. The IRS reviewed 692 hospitals in fiscal 2016, which ended late last month, Bloomberg BNA has reported. Of those, 166 were referred for a closer “field examination ...
1. Pharmaceutical market players mostly deal with two regulators These are the Ministry of Healthcare of Ukraine (MOH) and the State Administration of Ukraine on Medicinal Products and Narcotic Drugs Control (SAUMP). The MOH is responsible for state registration of medicines, while the SAUMP deals with licensing, evaluation of good manufacturing practice (GMP) compliance, control over quality of medicines, and regulation of medical devices. 2 ...
On May 5, 2016, the White House issued a report citing a variety of issues with the use of non-compete agreements advocating for non-compete reform at the state and federal level.1 According to the White House report, with respect to healthcare services (i.e., physicians, nurses, psychologists, social workers and other medical professionals), noncompetes have the potential to interfere with the quality of care by restricting consumer choice ...
Media reports are letting us know that the "Serbia - A Strategic Crossroads between Western and Eastern Europe," conference was held in Paris on 15 September, where the French companies were presented with the political and economic environment in Serbia, as well as with the ensuing investment opportunities and the possibility of financing economic projects ...
The contemporary business world has become fundamentally tied in with the progress of globalisation, and for anyone involved in it, that is no secret. Anybody would be hard pressed to find an industry that can exist and sustain itself in a purely national context, without – at least in some regard – relying on either a piece of legislation or a practice trend that is related to whatever kind of international functioning ...
Last June 16, the Superior Court of Québec1 rendered a safeguard order in an injunction proceeding in favour of a health-care institution the purpose of which was to set conditions for the visits of the daughter of a user of the institution who was an incapable person lodged there, as well as her interactions with the user and the staff ...
Recent news reports from Bosnia tell us that the BiH government, represented by the federal prime minister for economic issues and investments, Suvad Osmanagic, paid a visit to Bihac with Ludovico Camozzi, the president and owner of Camozzi – an Italian company that produces industrial automation machinery. The main purpose of this visit was to see Kombiteks, a textile production company that has been in bankruptcy and in and out of operation for the past 15 years ...
In the last several years, Texas has generated significant news stories related to the disagreements between the Texas Medical Board (“TMB”) and Teladoc, a telehealth medical provider. The original dispute centered around the right of telemedicine providers to treat Texas residents without an initial in-person visit, which some would argue circumvents the establishment of the practitioner-patient relationship ...
With healthcare costs expected to soon exceed twenty percent of the United States economy, the healthcare industry represents fertile ground for innovation. From medical devices and pharmaceuticals to methods for managing patient data, new technologies continue to improve patient care and outcomes. Such innovation is vital for ensuring that the healthcare industry continues to meet the demands of aging populations in the 21st century.http://executivenashville ...
Consent to End-of-Life Care Article 11 of the Civil Code of Québec1 states that no one can be made to undergo care without his consent. The Act respecting end-of-life care2 ("the Act"), passed by the National Assembly of Québec, came into force on December 15, 2015. Since that date, a person can give or refuse consent to specific forms of end-of-life care, provided he has given advance medical directives ("AMDs") for that purpose ...
The most recent example of a fashion designer losing the right to use his/her name came about this week. Karen Millen lost her court battle to challenge the agreement reached after the sale of her business to Baugur for £95m in 2004 which stated that she could not use her name in business in the future ...
The Construction (Design and Management) Regulations (Northern Ireland) 2016 ("CDM 2016") come into force on 1 August 2016. The legislation includes transitional provisions, so that, where a project has already started by 1 August 2016, the Client must appoint a Principal Designer before 1 August 2017 (unless the project ends before that date). In the meantime, the existing CDM Co-ordinator must comply with the duties of a Principal Designer ...
On July 25, 2016, China Food and Drug Administration (“CFDA”) published the latest "Measures for the Administration of Drug Registration (revised draft)” (“Latest Revised Draft”) for public comments1 ...
On July 7, 2016, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule intended to prohibit hospitals operating certain off-campus provider-based departments (PBDs) from billing under the Outpatient Prospective Payment System (OPPS). In an effort to implement Section 603 of the Bipartisan Budget Act of 2015, CMS says the proposed rule will save about $500 million a year by refocusing payments on the patient rather than the clinical setting ...
The Health Care Arbitral Tribunal (Arbitral Tribunal) has pronounced a decision on a dispute between an independent medical specialist and a Medical Specialist Company (MSC) for the first time since the introduction of the comprehensive rates on 1 January 2015. Although neither party has terminated the existing (membership) agreement between them, the Arbitral Tribunal is of the opinion that termination of membership and deregistration of the specialist from the members' register are justified ...
Last week, Governor Snyder wrote Michigan's congressional delegation to stress the importance of fully funding upgrades to the Soo Locks. Snyder urged Congress to replace the Davis and Sabin Locks with a single, larger lock that would provide redundancy should the Poe Lock fail. The Poe Lock is currently the only lock capable of handling the 1,000-foot freighters used to transport raw materials like iron ore ...
Late last week, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule intended to prohibit hospitals operating certain off-campus provider-based departments (PBDs) from billing under the Outpatient Prospective Payment System (OPPS). In an effort to implement Section 603 of the Bipartisan Budget Act of 2015, CMS says the proposed rule will save about $500 million a year by refocusing payments on the patient rather than the clinical setting ...
