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 ...
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 ...
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 ...
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 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 ...
The home health industry could see its profit margins shrink further as a result of proposed updates to the Home Health Prospective Payment System (HH PPS) released by the Centers for Medicare & Medicaid Services (CMS) earlier this week. This is the fourth and final year of payment reductions mandated by the Affordable Care Act in response to perceived Medicare overpayments to home health agencies. Profit margins are estimated to average 17.2% for the home health industry, and $17 ...
For the past several years, the healthcare industry has been targeted by union organizers hoping to add nurses, physical therapists and others to their ranks. In the first half of 2015, there were more than 150 union elections in the healthcare industry, with unions winning more than three-quarters of these elections ...
On May 10, 2016, the Québec Court of Appeal1 confirmed a Superior Court decision allowing an application for authorization of treatment and placement to a patient. The application had been brought by the Douglas Mental Health University Institute, commonly known as the Douglas, or the Douglas hospital ...
In a unanimous decision rendered on May 16, 2016,1 the Québec Court of Appeal confirmed that the delivery of ophthalmic lenses purchased online from suppliers who are not members of the Ordre des optométristes (Order of Optometrists) (?Order?), or the Ordre des opticiens d?ordonnances (Order of Dispensing Opticians), does not violate the Optometry Act 2(?OA?) or, by necessary extension, the Dispensing Opticians Act ...
Yesterday, the Supreme Court decided Universal Health Services, Inc. v. United States ex rel. Escobar, a case that many hoped would provide much-needed clarity on the viability of the implied certification theory of liability in False Claims Act cases. While the Court held the implied certification theory as a viable basis to impose liability, the ruling did little to provide the hoped-for clarity ...
As the overall level of convergence between industries in the business world keeps increasing, it is only logical for the related legal aspects to follow suit every step of the way ...
Last week, Waller co-hosted a roundtable discussion on interoperability with Brentwood Capital Advisors and were joined by healthcare IT companies, investors, providers and payors. Will Morrow, VP of HCA’s Health Insight Capital, and Hal Andrews, President of Healthcare for Digital Reasoning, kicked off the discussion with a case study on HCA’s work to achieve data interoperability and how HCA’s strategy led to its recent investment in Digital Reasoning ...
Following up on the passage of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), the Department of Health and Human Services (HHS) recently issued a proposed rule to replace the Medicare sustainable growth rate (SGR) methodology which was repealed by MACRA. The proposed rule would implement the Merit-based Incentive Payment System (MIPS) to replace SGR and establish incentives for participation in Advanced Alternative Payment Models (Advanced APMs) ...
The U.S. International Trade Commission (“ITC”) recently issued a Final Determination concluding that certain dental implants imported by Instradent USA, Inc. and by JJGC Industria e Comercio de Materiais Dentarios S/A of Brazil (“Respondents”) infringe U.S. Patent Numbers 8,714,977 and 8,764,443 and should be blocked from entry into the United States ...
