With the signing of a Protocol of Amendments (“PoA”) and the approval by the U.S. House of implementing legislation, the United States, Canada and Mexico are on track for final approval of the US-Canada-Mexico Agreement (the “USMCA”) by the middle of February 2020, which is the anticipated time frame for the vote by the U.S. Senate. If that proceeds as expected, the USMCA would take effect 90 days later, before the end of May ...
Summary of Public Policy and Prior Amendments The Minimum Fuels Storage Public Policy (the “Public Policy”) was released by Mexico’s Ministry of Energy (“SENER”) on December 12, 2017. The objective is to improve energy security in Mexico and ensure adequate energy supply and competitive prices, through the establishment of mandatory minimum fuel inventories and reporting obligations ...
Under a new state law that takes effect January 1, 2020, California health care facilities and other entities must report any written allegations that a physician or other healing arts licensee has sexually abused or engaged in sexual misconduct with respect to a patient. Sexual misconduct is defined as "inappropriate contact or communication of a sexual nature." SB 425 (Hill) amends the Business and Professions Code to add a new provision, Section 805.8 ...
The Danish Regions have proposed a new model for establishing a so-called Treatment Council which is to assess whether the price of treatments and health technology measure up to the effect for the patients. The model will now go out for consultation. The purpose and scope In their proposal, the Danish Regions want to establish a Treatment Council which is to make recommendations regarding the use of medical devices and health technology ...
Starting next year, California residents who don’t have health care coverage could face a state tax penalty. Under the new Minimum Essential Coverage Individual Mandate, California residents who fail to maintain minimum essential coverage for themselves and their dependents could owe a state tax penalty, unless they qualify for an exemption ...
Recently, in Amgen Inc. v. Hospira, Inc.,[1] the Federal Circuit clarified the limits of the Safe Harbor defense in cases involving patented manufacturing methods. In a case brought in the District of Delaware, Amgen alleged that Hospira infringed several patent claims over methods of manufacturing erythropoietin (EPO), a biologic drug used to treat anemia ...
The Committee on Foreign Investment in the United States (“CFIUS”), the interagency panel at the Department of the Treasury that reviews transactions for potential national security risks, recently released the public version of its latest annual report to Congress ...
The Ohio Board of Pharmacy (“Board of Pharmacy”) recently issued a notice to all Board of Pharmacy licensees to be on alert for a scam being perpetrated against Ohio health care providers ...
Will the release of its digital currency be China’s next salvo in its bid for world domination?One of the biggest developments in global finance has recently occurred, but not enough people are talking about it. It features technology, money and a battle between global superpowers ...
Carey partner, Diego Peralta, and associate, Vesna Camelio, contributed to the Q&A section of the Chilean chapter in the first edition of the “Foreign Direct Investment Regimes: A practical cross-border insight into FDI screening regimes”. To read the full article, click here: https://www.carey.cl/download/filebase/noticias/_notes/Chilean-chapter-ICLG-Foreign-Direct-Investment-Regimes ...
On 7 August 2019 the Federal Administrative Court annulled a Federal Office of Public Health (FOPH) order that had limited the price increase of a medicinal product on the list of specialities to two years. The product manufacturer had requested a price increase under Article 67(2) of the Healthcare Insurance Ordinance (SR 832.102), having incurred higher costs following the loss of two suppliers ...
Beginning Dec. 1, 2019, pharmacists licensed by the State of Ohio Board of Pharmacy (“Board”) will have new reporting requirements. The Board enacted similar reporting requirements for pharmacy interns, pharmacy technician trainees, and registered and certified pharmacy technicians. These new reporting requirements add to existing compliance considerations and burdens for licensees, registrants, their employers, and owners and operators of retail and institutional pharmacies ...
The dangers of workers developing silicosis amid the fabrication of engineered stone has become a topic heavily discussed in the news and elsewhere recently. Silicosis is a lung disease that develops from the exposure and inhalation of silica particles. On October 2, National Public Radio (“NPR”) aired a story entitled “Workers Are Falling Ill, Even Dying, After Making Kitchen Countertops ...
The U.S. Department of Homeland Security (DHS) published a final rule on January 11, 2019, introducing electronic registration requirement for employers seeking to file H-1B cap-subject petitions. The final rule went into effect on April 1, 2019, though the electronic registration requirement was suspended Fiscal Year 2020 (October 1, 2019 – September 30, 2020) to allow USCIS to complete user testing and ensure the system and process are fully functional ...
The U.S. District Court in Portland, Oregon, issued a 28-day temporary restraining order (TRO) in an unusual weekend session just before the “Presidential Proclamation on Suspension of Entry of Immigrants Who Will Financially Burden the United States Healthcare System” was to go into effect on November 3, 2019. Judge Michael H. Simon agreed to “freeze things the way they are” so a determination can be made on the merits of the case ...
This fall, an outbreak of lung illnesses allegedly related to vaping ignited public hysteria and legislative reactions in many states. The vaping and cannabis industries are already paying, and will continue to pay, high reputational and policy costs associated with these events, and the industries should also be aware that the widespread nature of reported injuries could lead to a substantial amount of costly mass tort litigation ...
Almost at the same time as the much-noticed and controversially discussed Directive on Copyright in the Digital Single Market (see Update IP No. 12: Agreement on the Reform of the Digital Copyright Law) and barely noticed by the public, another European Directive on copyright law was adopted ...
The U.S.-China trade dispute continues to simmer with multiple significant developments in the past several weeks: The Office of the U.S. Trade Representative (USTR) announced the exclusion process for Chinese imports subject to List 4A Section 301 tariffs will open on Oct. 31, 2019 and conclude on Jan. 31, 2020. List 4A and 4B tariffs on an estimated $300 billion of goods imported from China, effective Sept. 1, 2019 and Dec ...
With the recent proliferation of mass shootings and other deadly incidents, several states have taken on the issue of allowing mental and/or emotional impairments caused by post-traumatic stress disorder (PTSD) to be a compensable workers’ compensation condition for first responders without the requirement of a physical injury. In June 2019, House Bill 80, the budget bill for the Ohio Bureau of Workers’ Compensation, included such a proposal ...
In the False Claims Act (FCA) case of Feinwachs v. Minnesota Hospital Association, the district court recently upheld relator David Feinwachs’ claim of work-product privilege over emails sent to his work email account. No. 11-cv-0008, 2019 U.S. Dist. LEXIS 155027 (D. Minn. Sept. 11, 2019). Feinwachs was formerly general counsel of the Minnesota Hospital Association (MHA), a trade association of Minnesota hospitals and health care systems ...
Acting Food and Drug Administration (FDA) Commissioner Norman Sharpless has issued a statement warning Americans to stop using vaping products that emit THC until further testing can be done. Federal and state public health agencies, including the FDA, have been investigating an unprecedented wave of 1,000-plus cases of severe lung injuries and deaths among consumers who claimed they used vaping products containing THC, nicotine, or both ...
On Sept. 30, 2019, the IRS issued proposed regulations regarding how the employer-shared-responsibility provisions of the Affordable Care Act (ACA) and certain nondiscrimination rules under the Internal Revenue Code (Code) will apply to individual coverage health reimbursement accounts (HRAs). The proposed regulations aim to facilitate the adoption of individual coverage HRAs by employers on or after Jan. 1, 2020. Background On Oct ...
The Federal 340B Drug Discount Program (the “340B Program”) is a budget-neutral drug-pricing program that allows certain hospitals and clinics (“Covered Entities”) to buy discounted medication from drug manufacturers ...
Effective Oct. 17, 2019, hospital outpatient departments (HOPDs) and other facilities which previously were exempt from the Ambulatory Surgical Facility (ASF) licensure requirement may now meet the criteria of an ASF. Governor Mike DeWine’s budget bill contained provisions which modified the definition of an ASF and will expand the number of facilities subject to regulation under Ohio law as an ASF ...
