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”) ...
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 ...
Are you ready to disclose? All Transfers of Value (ToV) from 2015 must be disclosed publicly via the Irish Pharmaceutical Healthcare Association (IPHA) central reporting system by 1 July 2016. This relates to all ToVs that were made by pharmaceutical companies to Healthcare Providers (HCPs) and Healthcare Organisations (HCOs) in connection with the development and sale of prescription only medicinal products for human use ...
On February 1, 2016, the Superior Court of Québec rendered a significant decision in the area of civil liability in the context of the practice of a sport1. The judgment was widely reported in the media due, on the one hand, to the importance of the amount granted by the judge (8 million dollars) and, on the other hand, because it is closely related to the practice of the national sport of Canadians ...
On February 18 last, the Supreme Court of Canada1 denied leave to appeal in the matter of Intact Compagnie d’assurance c. 9221-2133 Québec inc.2, thus confirming the principles applicable to the duty of the insured to collaborate ...
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 ...
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”) ...
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 ...
Winter Storm Jonas has finally departed the mid-Atlantic, leaving behind snow depths best measured with a yardstick and, now, mounting reports of significant damage to property and resulting interruptions to businesses near and far from the path of the storm ...
Real estate professionals, owners, managers, investors and lenders, as well as anyone else involved in today’s real estate market, face a variety of risks of loss. Here are ten ways insurance can help mitigate potential liabilities. 1. Additional Insured Coverages. Real estate transactions are complex, with multiple parties with diverse roles and durations of involvement. This means multiple policies of insurance ...
Over the past weekend, a series of tornadoes and severe storms caused significant injuries and property damage across seven states, including Texas. In Garland and Rowlett, northeast of Dallas, wreckage from businesses and homes, trees, power lines, cars and other debris litter the streets for miles ...
The court of appeal of Quebec recently ruled on a leave to appeal from an interlocutory judgment dismissing a wellington type motion seeking to order an insurer to take up the defence of its insured.The decision of the Court inTechnologies CII inc.v.Société d’assurances générales Northbridge1follows the one issued on April 21, 2015 by the Honourable Michel A ...
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”) ...
Empezaron las eliminatorias al próximo Mundial pero las investigaciones por sobornos de la FIFA continúan – tendrán cobertura bajo pólizas de seguros las compañías y altos ejecutivos siendo investigados?El Comité de Ética de la FIFA anunció el 8 de octubre la suspensión provisional por 90 días de Joseph Blatter, presidente de la FIFA, y de Michel Platini, presidente de UEFA y vicepresidente de FIFA, entre otras suspensiones que fueron anunciadas en ese mismo momento ...
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 ...
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 ...
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 ...
The financial pressures resulting from the “narrow network” phenomenon are well-known to healthcare providers and payers. Many providers have been eliminated from existing networks in order to allow participating providers access to a greater volume of patients. Those remaining providers have seen lower reimbursement rates and other cost containment measures ...
A Texas federal court recently ordered an insurer to reimburse an oil and gas company for costs and expenses incurred while defending against environmental claims. The court found that a duty to defend existed even though the insured failed to immediately notify the insurer of the occurrence, giving rise to the claim as required by the insurance policy, and despite alleged willful miscon- duct that was excluded from coverage under the policy ...
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 ...
This is the age of government regulation. Businesses pay millions of dollars each year to comply with ever-increasing regulatory requirements intended to avoid catastrophic loss to persons and property. While corporate America underwrites the lion’s share of the cost associated with enhanced safety, the benefits are realized primarily by consumers, politicians and insurers. Yes, insurers. A dollar spent on preventing loss is a dollar saved by insurance companies ...
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 ...
What Is the Size of the Market and What Are Current Trends in Switzerland? Life Sciences is one of the most dynamic and most rapidly growing sectors in Switzerland with respect to both the industrial and the academic dimension. In 2013, the total financ-ing volume amassed by Swiss biotech companies more than doubled compared to the previous year’s figure, reaching USD 325 million, which amounts to an increase of 112% ...
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 ...