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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 ...

Gianni & Origoni | March 2016

1. Introduction  On 21st January 2016, the Italian Cabinet gave the green light for the “Reorganization, rationalization and simplification of Port Authorities” decree (the “Ports Decree”), which reviews a system which has been in place for over 20 years. The Ports Decree is part of the re-launch of ports and logistics in Italy promoted by the Ministry for Infrastructure and Transport (“MIT”) ...

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 ...

Haynes and Boone, LLP | February 2016

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”) ...

Lavery Lawyers | February 2016

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 ...

Haynes and Boone, LLP | November 2015

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”) ...

Makarim & Taira S. | October 2015

Under Minister of Transportation of the Republic of Indonesia Regulation No. PM 3 of 2015 dated 7 January 2015 on the Implementation of One-Stop Integrated Services in the field of Transportation at the Indonesia Investment Coordinating Board (BKPM) (“Regulation 3/2015”), the Minister of Transportation has now delegated its authority to issue transportation business licenses for capital investment to the Head of BKPM. The Business Licenses which have been delegated are: 1 ...

Haynes and Boone, LLP | September 2015

On September 25, 2015, the Texas Board of Pharmacy (“TBP”) issued proposed rules that will allow pharmacists to substitute interchangeable biological products for brand name drugs. Currently, Texas regulations only allow for the substitution of lower-priced, generically equivalent drugs instead of certain brand name drugs. In contrast, the proposed rules allow pharmacists to dispense interchangeable biological products ...

Haynes and Boone, LLP | September 2015

In a short three-week period, the U.S. Department of Justice announced three large, multi-million dollar False Claims Act settlements involving Stark Law violations. Each of the three cases alleged that health systems compensated physicians in excess of fair market value, and in excess of collections for services personally performed by those physicians, in order to induce referrals ...

Lavery Lawyers | September 2015

On August 18, 2015, the Tribunal administratif du Québec (TAQ) confirmed the decision of a health institution to not renew the status and privileges of one of its physicians after he refused to undergo refresher training to acquire skills that were necessary to perform his new duties.1 The physician in question, a hematology specialist, had been hired as a researcher several years ago ...

Lavery Lawyers | September 2015

After eight years of operation, the International Registry established pursuant to the Cape Town Convention and the Aircraft Protocol (in force in Quebec since April 1, 2013) has undergone a significant update. The Registry’s website has undergone a complete overhaul in two phases, the first of which was launched in September 2013 ...

Haynes and Boone, LLP | August 2015

The FDA recently issued final guidance regarding the size, shape, and other physical characteristics of generic-manufactured tablet and capsule dosage forms. The guidance noted that differences in physical characteristics of a dosage form could affect patient compliance and acceptability of medication regimens, or could lead to medication errors. The main reason for the FDA’s guidance appears to be that many patients can experience difficulty swallowing tablets and capsules ...

DFDL | July 2015

Despite the apparent opening of the door for foreigners to engage directly in retail trading in Myanmar under the Myanmar Investment Commission (MIC) Notification No 49 of 2014, in practice this door was still closed to foreigners in the new car sales sector.  With limited exceptions (discussed below), foreigners could not, even on the basis of Notification 49: (i) import new cars (ii) register new cars in their name (iii) sell those cars or (iv) own and operate a new car showroom ...

Lavery Lawyers | July 2015

In a decision rendered on April 30, 20151, the Administrative Tribunal of Québec (the "ATQ") upheld a decision of the board of directors of a university hospital centre that refused to renew the status and privileges of a physician who failed to fulfill the obligations associated with the enjoyment of these privileges. Firstly, it should be noted that the applicant's clinical competence was not questioned in this case ...

Carey | June 2015

On June 6th, 2015, Law No. 20,850, which creates the Financial Protection System for Diagnostics and Treatment of High Costs, and pays posthumous tribute to Luis Ricarte Soto Gallegos, has been published. This law creates a financial protection system for diagnostics and high cost treatments which will be defined by the Ministry of Health by means of a Supreme Decree ...

Haynes and Boone, LLP | June 2015

There have been recent interesting developments in Latin American aviation. Set forth below is a discussion of some of them. Topics include: General Outlook Key Mexican Reforms U.S. and European Expansion Mexico: Dynamic Aviation Sector The Venezuela Crisis Excerpted from Latinvex. To read the full article, click here ...

Lavery Lawyers | April 2015

In a judgment handed down on January 30, 2015, the Court of Québec held that the failure to respect the prescribed time limits or the violation of a patient’s fundamental rights and freedoms does not lead to the automatic exclusion of a psychiatric examination report concluding that the patient should be confined ...

Haynes and Boone, LLP | April 2015

On April 10, 2015, the Texas Medical Board (“TMB”) voted in favor of adopting amendments to the rules governing telemedicine. The revised rules, which will significantly limit the ability to treat patients via telephone and video consultation, take effect June 3, 2015. TMB took its first steps to curb telemedicine in January 2015 by passing an emergency measure that prohibited prescribing drugs without an initial in-person visit ...

Asters | March 2015

Registration of an aircraft: Civil aircraft are registered in the Civil Aircraft Register maintained by the State Aviation Administration of Ukraine (SAAU). Application for an aircraft's registration may be submitted by the owner of an aircraft or a person authorised by the owner. Record of person's ownership in the Civil Aircraft Register does not evidence title to an aircraft. Information recorded in the Civil Aircraft Register is published on the SAAU's website ...

ENSafrica | March 2015

In the recent judgment of “The Owners of the mv “Silver Star” v Hilane Limited”*, several important principles were established, namely: Full effect must be given to the right to proceed against an associated ship of a charterer in respect of a maritime claim that arises in the course of the Charter ...

Haynes and Boone, LLP | March 2015

In recent remarks to a compliance conference for the pharmaceutical industry, the SEC’s Director of Enforcement, Andrew Ceresney, addressed FCPA issues that commonly arise in the industry. According to Ceresney, the SEC is continuing to focus on pharmaceutical companies because their operations typically pose a high risk for FCPA violations ...

Haynes and Boone, LLP | March 2015

Understanding the Texas Attorney General’s efforts on enforcement of healthcare fraud and abuse matters often is challenging. Recent activities, however, give physicians and other providers insight into the agency’s priorities ...

Haynes and Boone, LLP | March 2015

On March 10, 2015, the Centers for Medicare & Medicaid Services (CMS) Innovation Center released its newest model in alternative care delivery: the Next Generation ACO Model. This new version of accountable care organization (ACO) builds upon the experiences from the Pioneer ACO Model and the Medicare Shared Savings Program (MSSP) to set more predictable financial targets, enable providers and beneficiaries to better coordinate care, and provide overall high quality care ...

Haynes and Boone, LLP | March 2015

In an opinion that will certainly cause Texas hospitals, physicians, nursing home operators and other healthcare providers to consider whether they should insert standard arbitration clauses into their pre-treatment agreements, the Texas Supreme Court held last week that the Federal Arbitration Act (“FAA”) preempts the more stringent arbitration requirements set forth in the Texas Medical Liability Act (“TMLA”).The Fredericksburg Care Co., L.P. v. Juanita Perez et al, No. 13-0573, 2015 Tex ...

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