In Esso Australia Pty Ltd v The Australian Workers' Union [2015] FCA 758, the Federal Court upheld the validity of some, but not all, orders made by the Fair Work Commission (FWC) against industrial action at Esso's Longford Plant in Victoria ...
It’s no surprise that the National Cybersecurity Center of Excellence (NCCOE) has extended the public comment period for one of its newest guides, “Securing Electronic Health Records on Mobile Devices ...
CMS and OIG Finalize Waivers for ACOs in the Medicare Shared Savings Program Effective October 29, 2015, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) of the Department of Health & Human Services (“HHS” or “the Department”) finalized the waivers of certain fraud and abuse laws to specified arrangements involving accountable care organizations (“ACOs”) in the Medicare Shared Savings Program (“MSSP”) ...
Many healthcare boards believe that they have satisfied the 501(r) community health needs assessment (CHNA) requirements by completing their organization’s CHNA report and adopting an implementation strategy. After doing that, the board may feel ready to focus on other pressing issues until the next three-year CHNA deadline ...
Over the past year, the Tribunal administratif du Québec (TAQ) has issued several rulings dealing with oversight of the medical practice of professionals working in health and social services institutions. Several of these rulings will be of interest to institutions since they set out principles that tend to confirm the existence of a form of management rights over physicians, despite the lack of the traditional relationship of subordination between such institutions and their physicians ...
After a long wait, on February 12, 2016, the Centers for Medicare & Medicaid Services for HHS (“CMS”) issued a final rule that clarified the obligations of Medicare providers and suppliers to report and return overpayments within 60 days (the “Rule”).1 The Rule becomes effective on March 14, 2016. The Rule, which applies only to Medicare Part A and B providers and suppliers, enforces a statutory requirement from 2010 implemented by the Affordable Care Act (“ACA”) ...
The Modern Slavery Act 2015 introduces a new area of compliance for commercial organisations. The Act is amongst the toughest anti-slavery and human trafficking legislation in the world. Although legal penalties are restricted, interest from patients, consumers, investors, NGOs, pressure groups and brand risk is expected to enforce compliance ...
Increased deal activity is likely in Australia's health and aged care sector in 2016, driven by:• investment interest from China• Australian players targeting outbound opportunities through joint ventures and partnerships; and• consolidation in the aged and home care services areas.Rapidly ageing populations across our region are driving demand for high quality health care, especially in countries such as China and Japan ...
On January 4th, 2016, the President of the Republic introduced a series of amendments to the bill of law that, “modifies the Health Code in order to regulate generic bioequivalent pharmaceutical products and prevent the vertical integration of pharmaceutical laboratories and pharmacies”, – Bill No. 9914-11- (“Pharmaceutical Bill II”) ...
Following publication of the Regulation (EU) No. 2015/2424 which is part of the reform legislative package that also replaces the existing Trade Mark Directive, the long awaited reform of the existing Community trade mark will enter into force on 23 March 2016. The most evident change is that the Community trade mark will be renamed the European Union trade mark (EUTM), adopting the terminology of the Lisbon Treaty ...
Special Economic Zones (“SEZs”) are geographically designated areas within a country that are set aside for specifically targeted economic activities, supported through special arrangements (that may include laws) and systems to promote industrial development. An SEZ is meant to be an economic development tool to promote rapid economic growth by using various support measures to attract targeted foreign and domestic investments and technology ...
On March 30, the Department of Justice (DOJ) announced a major new initiative to target quality of care and fraud and abuse in elder care by forming 10 Elder Justice Task Forces throughout the United States. The DOJ intends to build these task forces on interdisciplinary teams – including Health Care Fraud Enforcement Action or HEAT Teams – already at work in several districts across the country. The teams include representatives from the U.S ...
Last week, Greece's biggest tobacco company, "Seke", acquired four hectares of land in the industrial zone of Kruševo, Macedonia. It has been reported that the company's plan is to build a factory for tobacco processing there, and that the honorary investment in this case amounted to EUR 5 million. The main cause of interest in this area for Seke were the region's favourable conditions for tobacco growth, as well as the presence of good-quality, highly professional workers ...
As the delivery of health care continues to evolve and hospitals bear additional pressures to adapt to new payment models, more nonprofit hospitals are partnering with for-profit providers, through a sale, joint venture, or other arrangements. Partnerships between independent nonprofit hospitals and larger health care systems (nonprofit and for-profit) have been growing over the past two decades ...
A number of events have occurred recently involving the Federal Trade Commission and healthcare entities. First, garnering the lead spotlight, the FTC began presenting its case in the U.S. District Court for Northern Illinois to enjoin a merger between Advocate Health and NorthShore University HealthSystem, two large Chicago-area health systems ...
Last month, CMS issued a proposed rule that would drastically expand the agency’s authority to further its program integrity efforts through the provider and supplier enrollment process. This proposed rule, referred to as CMS-6058-P, (located in the Federal Register at 81 Fed. Reg. 40 ...
On April 18, the Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services issued revised guidance regarding exclusions imposed under section 1128(b)(7) of the Social Security Act ...
On April 19, 2016 Association of European Business (hereinafter – “AEB”) and the Russian Federal Antimonopoly Service (hereinafter – the “FAS”) presented the Code of Good Practice in the Pharmaceuticals Industry (hereinafter – the “Code”). The full text of the Code (both in Russian and English) is available at the official web-site of the antimonopoly authority (http://fas.gov.ru/documents/documentdetails.html?id=14513). Below is short outline of the Code. 1 ...
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 ...
1 Which legislation sets out the regulatory framework for the marketing, authorisation and pricing of pharmaceutical products, including generic drugs? Which bodies are entrusted with enforcing these rules? The relevant legislation includes the following: • Law on Medicines 1996;
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) ...
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 ...
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 ...
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 ...
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 ...
