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Waller | June 2016

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 ...

Waller | June 2016

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 ...

Waller | June 2016

The United States Supreme Court declined yesterday to hear arguments in Home Care Association of America, et al. v. Weil, a case challenging the Department of Labor’s Final Rule that extended overtime and minimum wage protections to previously exempt home care workers ...

Lavery Lawyers | June 2016

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 ...

Garrigues | June 2016

The recent First Chamber Supreme Court’s (SC) case law has been consistent when determining that the granting of clientele compensation in case of unilateral termination of the distribution agreement by the manufacturer could not be made automatically by analogous application of the Agency Contract Act, but by taking into account the particular casuistry ...

Lavery Lawyers | June 2016

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 ...

Waller | June 2016

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 ...

Waller | May 2016

  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 ...

Waller | May 2016

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) ...

Waller | May 2016

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 ...

Asters | May 2016

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;

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ALRUD Law Firm | April 2016

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 ...

Haynes and Boone, LLP | April 2016

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 ...

Waller | April 2016

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 ...

Waller | April 2016

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 ...

Waller | April 2016

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 ...

Karanovic & Partners | April 2016

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 ...

Waller | April 2016

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 ...

ENSafrica | March 2016

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 ...

Karanovic & Partners | March 2016

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 ...

Carey | March 2016

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”) ...

MinterEllison | March 2016

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 ...

Shoosmiths LLP | March 2016

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 ...