Trademark law in Canada is undergoing a major change this year that will go into effect on June 17, 2019. We have compiled the three things you need to know and important steps you may want to take before the June 17, 2019 date passes. 1 ...
Dinsmore’s Government Relations team was involved in several significant legislative initiatives affecting the health care sector during the 2019 regular session of the West Virginia legislature. Most notably, Dinsmore was involved in the passage of HB 2010, relating to foster care ...
On May 24, 2019, the U.S. Department of Health and Human Services (HHS) proposed revisions to regulations issued under Section 1557 of the Affordable Care Act (ACA) (the Proposed Rule). The Proposed Rule would revise certain provisions of the current Section 1557 rule that federal courts have ruled as likely unlawful, and eliminate the requirement that covered entities publish non-discrimination notices and include taglines in foreign languages on all significant publications ...
On May 24, 2019, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a new fact sheet providing a compilation of all provisions through which a business associate may be held directly liable with the HIPAA Privacy, Security, Breach Notification, and Enforcement regulations (collectively the HIPAA Rules) ...
Environmental Protection Agency (EPA) has issued a new rule that will impact the operations of a wide-range of health care facilities and the manner in which those facilities manage hazardous waste pharmaceuticals ...
On May 10, 2019, the Centers for Medicare & Medicaid Services (CMS) published its final rule, 42 CFR 403, requiring drug manufacturers to disclose the price of prescription drugs in direct to consumer (DTC) advertisements. Publication of the final rule was preceded by a lively comment period that commenced on October 18, 2018 ...
Brenna K. Legaard is a registered patent attorney with Schwabe, Williamson & Wyatt. Legaard wrote the following op-ed on the use of blockchain technology in health care. When health care professionals and consumers think of blockchain, their minds very likely go to famous cryptocurrencies like Bitcoin. But blockchain technology can be applied to so much more, including to the field of health care ...
On April 2, 2019, the United States Environmental Protection Agency (EPA) published its proposed “Modernizing Ignitable Liquids Determinations” rule in the Federal Register.[1] Ostensibly, the rule is, as described in its title, an effort to “modernize” – i.e., update – certain aspects of the regulations relating to determining whether a waste is a hazardous waste based on the characteristic of ignitability, which are found in 40 C.F.R. 261 ...
The Ohio Bureau of Workers’ Compensation will no longer offer coverage for OxyContin by the end of 2019. The agency announced this change, given the drug’s potential for abuse, misuse, addiction, and dependence. The BWC will no longer pay for OxyContin or generic forms of the medication for workers who suffer an industrial injury on or after June 1, 2019. Injured workers who are currently on OxyContin will have until Dec ...
This article was written by Igor Angelovski and was originally published in Issue 6.2 of the CEE Legal Matters Magazine. “If you are a company conducting business in the automotive industry with intentions of expanding on the European market, where do you look? The answer may be the Central European country of Slovenia ...
On June 13, 2019, the Mine Safety and Health Administration (MSHA) announced it had completed its upgrade of its Mine Data Retrieval System (MDRS). Under the new system, mine operators will have new tools to help review compliance with MSHA regulations as well as assessing employment and production records. The upgraded system will also enable mine operators to track accidents, inspections, violation history, and health sampling data ...
Beginning July 1, 2019, the Ohio Department of Medicaid (ODM) is requiring all Ohio managed care plans to make room and board payments directly to hospice providers when hospice services are provided to individuals residing at skilled nursing facilities (SNF) ...
After nine years of deliberation, the Pennsylvania Board of Pharmacy (Board) issued final regulations (effective June 22, 2019) setting new standards for pharmacist compounding of drug products. While the final regulations are substantially less onerous than as originally proposed, the regulations represent the Board’s commitment to ensuring compounding is performed in a safe and reliable manner in Pennsylvania ...
The Department of Health and Human Services (HHS) and the Department of Justice (DOJ) recently released the Health Care Fraud and Abuse Control Program Annual Report. The 2018 Report highlighted key enforcement areas and policy considerations. The Health Insurance Portability and Accountability Act of 1996 established a national Health Care Fraud and Abuse Control Program (the Program) under the direction of the Attorney General and the Secretary of HHS ...
On July 23, 2019, the Ohio Department of Commerce will conduct a public hearing regarding proposed amendments to several Medical Marijuana Control Program rules. The Medical Marijuana Control Program allows individuals with specified medical conditions, upon the recommendation of an Ohio-licensed physician, to purchase and use medical marijuana. The rules govern the activities of medical marijuana cultivators, processors, and testing laboratories ...
Legislation Aligns State and Federal Laws On July 17, 2019, Ohio lawmakers passed Senate Bill (S.B.) No. 57, which decriminalizes hemp and creates licensure programs for those wanting to cultivate or process hemp and hemp byproducts. Ohio was one of the few states that did not update its statutes to align with federal regulations following the passage of the 2018 Farm Bill, which removed hemp as a controlled substance at the federal level ...
Overview Following the enactment of Law No. 33 of 2014 on Guarantees for Halal Products (“Law 33/2014”), its implementing regulation, Government Regulation No. 31 of 2019 (“GR 31/2019”), was recently issued and came into effect on 3 May 2019. In principle, Law 33/2014 requires that all products imported, distributed or traded in Indonesia be certified halal in accordance with Islamic principles ...
In 2016, the Centers for Medicare and Medicaid Services (CMS) issued regulations that prohibited long-term care facilities from entering into pre-dispute arbitration agreements with residents and their families. Shortly thereafter, those regulations were successfully challenged in federal court, and CMS has not attempted to enforce them. On July 18, 2019, CMS issued a final rule that will formally rescind the ban on pre-dispute arbitration agreements with long-term care residents ...
The Ministry of Health has published a new public consultation process regarding proposed modifications to the Preliminary Titles; II "Food"; XXVII "Of Alcoholic Beverages, Fruit and Vegetable Juices and Bottled Waters"; and XXIX “Of the Food Supplements and Foods for Athletes” of Decree No. 977/1997 that establishes the Sanitary Regulations for Foods (hereinafter, “ RSA ”) ...
On September 9, 2019, the U.S. Court of Appeals for the Eleventh Circuit issued an important decision for health care providers, especially those in the hospice industry. In U.S. v. AseraCare, Inc.,No.16-13004, Slip. Op. (11thCir. September 9, 2019), the Court held that a “reasonable disagreement between medical experts” about prognosis for a terminally ill patient, without more, cannot establish falsity. Slip. Op. at 3 ...
California Health and Safety Code section 1418.8 outlines the requirements a skilled nursing facility (SNF) must follow when a physician prescribes a medical intervention that requires informed consent for an "unfriended" resident, meaning an individual who lacks capacity and does not have a person with legal authority to make health care decisions on their behalf. Section 1418 ...
Two recent opinions of the California Court of Appeal address the enforcement of arbitration agreements in the senior care setting when executed by someone other than the resident. The Court of Appeal's decisions in Valentine v. Plum Healthcare Group, LLC (2019) 37 Cal.App.5th 1076 (Valentine) and Lopez v. Bartlett Care Center LLC (2019) ____ Cal.App ...
FDA announced it will open a public docket and hold an Immunology Devices Panel meeting to deliberate the potential for patients who receive medical device implants that contain select metal or metal alloys to develop immune and inflammatory reactions. The panel may provide input on scientific information the FDA should consider as part of premarket review and postmarket surveillance of metal-containing implants and dental amalgams ...
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 ...
Elite Dental Associates, Dallas (“Elite”) has agreed to pay $10,000 to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services and to adopt a corrective action plan to settle potential violations of the HIPAA Privacy Rule[1]. According to OCR, Elite is a privately owned dental practice in Dallas, Texas, providing general, implant, and cosmetic dentistry ...
