by Eric E. Kinder President Bush signed the ADA Amendments Act into law. The ADAAA significantly increases the scope of the Americans with Disabilities Act of 1990 as it has been interpreted by federal courts by overturning several United States Supreme Court decisions regarding the Act. According to the Congressional Committees that oversaw the passage of the ADAAA, these amendments will restore the original Congressional intent behind the ADA ...
In one of the first concrete developments related to the Affordable Care Act (ACA) changes following Dr Thomas E Price’s approval as Secretary of the Department of Health and Human Services (HHS), a Notice of Proposed Rule making was recently released by HHS. The recent release by HHS stated a goal of helping to stabilize the individual and small group marketplaces established by the ACA ...
External pressures, such as lower reimbursement rates and an overall shift in policy by the Centers for Medicare and Medicaid Services (CMS) and state Medicaid agencies have put significant financial and operational pressure on skilled nursing and other senior living operators in the United States ...
View the February 2017 Health Law Vitals Newsletter PDF. Final Guidance Sheds Light on Medical Device Reporting Requirements In November 2016, the U.S. Food and Drug Administration issued a final guidance on medical device reporting for manufacturers ("Final MDR Guidance") ...
Membership substitution transactions are the most common form of business combination transaction in the nonprofit hospital industry. They are also widely misunderstood and the source of many mistakes. Many large 501(c)(3)s have become more acquisitive as a result of economic pressures of the ACA. Nonprofit health systems have been getting much better at participating in and winning competitive sale processes, resulting in an increased use of this business combination form. http://www ...
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 ...
2016 proved eventful on both the political stage and in the world of media and entertainment law, and sometimes the two worlds even collided. The year saw its share of high profile media lawsuits, favorable Congressional actions, and, of course, a presidential election like none other. Here are ten stories that made an impact in 2016 and will likely continue to impact media and entertainment law for years to come ...
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 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 ...
It is not unusual for companies to choose famous and prestigious events, such as entertainment awards and sporting championships, as platforms to promote their products and services. The Olympic Games are no different. As the world´s most important sporting event, drawing the attention from individuals all over the world for more than two weeks, the Olympic Games are the perfect scenario for marketing actions ...
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 ...
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 ...
Recognising the great potential for film production and post production in South East Europe, a group of legal experts have gathered to develop industry expertise and work with organisations and Governments supporting this fledgling sector ...
An important piece of regulation has been introduced in Montenegro recently, through the reduction of VAT on catering services in four stars hotels (in the north of the country) and five-star hotels (on the seaside), which will be effective from 2018 ...
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 ...
