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Waller | July 2016

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 ...

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 ...

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 ...

Karanovic & Partners | June 2016

An encouraging news update comes from Croatia, as some of the recent reports claim that the Croatian IT market reached a value of EUR 950 million in 2015. According to IDC Adriatic – a regional branch of the global market intelligence provider – this shows an increase of 10.8% when compared to the previous year.IDC Adriatic added that a continuation of the IT market's recovery is expected in 2016 as well. More precisely, further strengthening of the market at an average annual rate of 6 ...

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 ...

Heuking | June 2016

The Hamburg data protection authority has imposed fines against the companies Adobe, Punica and Unilever, stating that they have continued to transfer personal data to the USA contrary to the stipulations of the Safe Harbor judgment. 1. The Safe Harbor judgment of the ECJ dated October 6, 2015 (legal matter C-362/14) makes it clear that European companies can no longer simply transfer personal data to the USA as a "non-secure third country" ...

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) ...

Lavery Lawyers | May 2016

In 20141, major retailers Best Buy Canada Ltd., Costco Wholesale Canada Ltd., Gap (Canada) Inc., Old Navy (Canada) Inc., Guess? Canada Corporation, Wal-Mart Canada Corp., Toys ?R? Us Canada Ltd. and Curves International Inc ...

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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Waller | April 2016

On April 27, 2016, Waller hosted the Middle Tennessee InfraGard Members Alliance’s Incident Response Briefing. The presenters highlighted increasing cybersecurity risks and the need for a proactive, coordinated approach to limit the impact of cybersecurity compromises. InfraGard is a partnership between the FBI and the private sector dedicated to sharing information and intelligence to prevent hostile acts against the United States ...

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 ...

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 ...

Karanovic & Partners | April 2016

The world is moving at a break neck pace, and a crucial element at the root of these changes are technological developments. As the global business landscape has been irrevocably altered by these developments, it was only a matter of time before each comprising industry would have had to adapt and – to a certain degree – reinvent itself as a consequence ...

Karanovic & Partners | April 2016

​There is encouraging news for those with plans of getting involved in a start-up project in Slovenia, as theSlovenian Enterprise Fundhas announced almost EUR 5 million to support innovative start-ups this year ...

Shearn Delamore & Co. | April 2016

The Copy Right Act 1987 provides a framework for the protection of copy right and enforcement through civil redress, as well as outlines the powers granted to state authorities for the enforcement of copy right and prosecution of copy right offences. The Copy Right Amendment Act 2012 (“2012 Amendment Act”) came into operation on 1st March 2012. The following is a summary of some of the amendmentspursuant to the 2012 Amendment Act ...