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 ...
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 ...
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 ...
For nearly the last 20 years, states have been legalizing hemp growth, production, and products.[1] While hemp remained illegal federally and was included in the definition of marijuana under the Controlled Substance Act, numerous states began exploring the validity of hemp as a viable product. Marijuana legislation was not far behind ...
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 ...
California Assembly Bill No. 205 was approved by Gov. Gavin Newsom on July 9, 2019. Assembly Member Tom Daly, who represents California’s 69th district of Orange County cities Santa Ana, Anaheim, and Garden Grove, introduced AB-205 to expand the definition of “beer” under Business & Professions Code §23006, which is part of the Alcohol Beverage Control Act. The new law is set to go into effect on Jan. 1, 2020 ...
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 Twenty-first Amendment—which repealed Prohibition—gives states broad authority to regulate alcohol within their borders. But can states impose residency requirements on alcohol retail licensees? The U.S. Supreme Court, by a vote of seven to two in Tennessee Wine and Spirits Retailers Ass’n v. Thomas, answered no. As state alcohol regulators adjust their licensing processes to comply with the ruling, retailers and wholesalers may see changes in the alcohol market ...
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) ...
Beginning next month, used car dealers in West Virginia may sell vehicles directly to consumers without a single warranty that the vehicles are operational or safe to drive. The so-called “As Is” bill – approved last March by the West Virginia Legislature – will allow merchants to make sales on an “as is” basis, effectively eliminating any implied warranties about a vehicle’s merchantability or fitness for a particular purpose ...
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 ...
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 ...
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 ...
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 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 ...
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 ...
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 ...
Whatever your views on Brexit, the deferment of the UK’s leaving date from the EU provided British industry some welcome breathing space to prepare for Brexit. Given the issues that still divide the two main political parties, the UK may yet leave the EU without a deal on 31 October ...
Many employers currently have employees on staff on temporary work visas, and employers likely know that in order to continue to employ employees not born in the U.S., the employer must sponsor the employee for permanent residency in the U.S. (i.e,. a green card). The green card process has multiple steps, which, depending on a variety of factors, may take several years to complete ...
FDA Announces Public Meeting for Responsible Innovation in Dietary Supplements Industry Recently, the Federal Food and Drug Administration (FDA) announced it will hold a full-day public meeting to discuss strategies for responsible innovation in the dietary supplement industry. The meeting will be held May 16, 2019, from 8:30 a.m. EST to 4 p.m. EST at the FDA Center for Food Safety and Applied Nutrition, Wiley Auditorium, located at 5001 Campus Dr., College Park, MD 20740 ...
Coordinating cross-border due diligence is a key skill that more often than not underpins complex, multi-jurisdictional merger and acquisitions (M&A) and private equity (PE)-led transactions. Where due diligence really adds value is in the early stages of the transaction, when local knowledge and expertise are vital to understanding the context of data room information ...
Recent events, including the investigations into Facebook’s handling of its users’ personal data, have highlighted the realization that personal data is, in today’s world, one of the most valuable resources for any business and that businesses not only collect and store their customers’ personal data but also use and even sell it for profit ...
