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 ...
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”) ...
The Environmental Protection Agency (“EPA”) is embarking on a compliance initiative to ensure that sources that handle hazardous waste are complying with the Resource Conservation and Recovery Act (“RCRA”) requirements, particularly that sources are operating within their correct generator status, disclosing certain hazardous waste activities, and submitting required reports ...
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 ...
Environmental groups are attempting to enlist the U.S. Department of Commerce in their fight against fracking operations and climate change by petitioning DOC to ban natural gas exports under the Energy Policy and Conservation Act of 1975 (EPCA).To read the full alert, click here ...
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 ...
On Monday, the Environmental Protection Agency (“EPA”) released its Clean Power Plan (“CPP”), the cornerstone of the Obama Administration’s multi-faceted regulatory approach to address climate change.1 The final rule is centered on reducing CO2 emissions from fossil fuel-fired power plants by 32 percent from 2005 levels by 2030 ...
Ahead of the recent election it was no secret that the Conservatives wanted to see a cut in taxpayer support for the development of wind farms. What did come as a surprise was the recent announcement by the Westminster Department of Energy and Climate Change (DECC) that the main form of subsidy for wind farms would suddenly be closed in March 2016 ...
In June 2015, the Superior Court of Québec sided with a real estate developer who applied for an order requiring the Quebec Ministry of Transport (MOT) to fix a highway interchange whose construction in 2007 caused the developer’s land to be flooded1. This article summarizes the court’s principal findings. The ruling has been appealed by the Quebec Ministry of Sustainable development, Environment and the Fight against climate change (MSDEF) ...
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% ...
Michigan vs. EPA, the Supreme Court continues to curtail EPA’s ability to regulate emissions from power plants by limiting the deference the Court will grant EPA on issues of statutory construction. In the 5 to 4 decision, authored by Justice Scalia and joined by Chief Justice Roberts and Justices Kennedy, Thomas, and Alito, the Court held that EPA’s air toxic standards for regulating mercury emissions from coal fired power plants were “unreasonable ...
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 ...
On May 23rd, Governor Abbott signed SB 709, fundamentally changing Texas’s contested hearing process for environmental permits. Effective September 1, SB 709 requires the Texas Commission on Environmental Quality to adopt rules implementing its changes by no later than January 1, 2016 and to provide notice before then that these changes apply to applications filed after September 1 ...
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 ...
On what grounds may a landowner who discovers soil contamination caused by an old heating oil tank sue the former owner of the property? In this bulletin we examine whether the warranty against latent defects found at Article 1726 of theCivil Code of Québeccan be invoked to have the sale annulled or to obtain a reimbursement of part of the purchase price. The recent decision of the Superior Court inDe La Ov.Sasson1is instructive in two respects ...
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 ...
“Waters of the United States” or “WOTUS” in the esoteric taxonomy of the Clean Water Act (“CWA”), is a term with which many are becoming increasingly familiar. This deceptively simple phrase is anything but simple in its application. The oil and gas industry is increasingly experiencing the U.S. Environmental Protection Agency’s (“EPA”) proclivity finding CWA jurisdiction through WOTUS interpretation. New proposed regulatory language issued by the EPA and the U.S ...
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 ...
