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 ...
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 ...
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 ...
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) ...
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 ...
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 ...
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 ...
In a recent case involving a health care facility, the NLRB issued a 3-1 decision that significantly changed a successor employer's bargaining obligations before imposing the initial terms and conditions of employment on a unionized workforce. While seemingly favorable to employers, the decision also serves as a reminder to companies that they should act cautiously and consult with counsel before they take over a business with a unionized workforce ...
The U.S. Food and Drug Administration (FDA) recently announced new steps it is taking to determine a framework for lawful marketing of appropriate cannabis and cannabis-derived products.[i] As expressed in the Agriculture Improvement Act of 2018 (the 2018 Farm Bill), the FDA has the authority to regulate products containing cannabis or cannabis-derived compounds ...
The Department of Health and Human Services Office of Civil Rights (OCR) Spring 2019 Cybersecurity Newsletter includes new recommendations regarding how HIPAA covered entities can prepare to defend against cybersecurity attacks such as advanced persistent threats (APTs) and zero-day vulnerabilities ...
On April 1, 2019, the Health Resources and Services Administration (HRSA) launched a secure website that lists the maximum price drug manufacturers may charge 340B-covered entities for 340B-eligible drug purchases (the 340B Ceiling Price Site). Drug manufacturers and 340B-covered entities may access the 340B Ceiling Price Site through their HRSA Office of Pharmacy Affairs information system (the 340B OPAIS) account here: https://340bopais.hrsa ...
A trio of federal statutes often referred to collectively as the P&A Acts, which includes the Protection and Advocacy for Individuals with Mental Illness Act (PAIMI), the Developmental Disabilities Assistance and Bill of Rights Act (PADD), and the Protection and Advocacy of Individual Rights Act (PAIR), authorize the creation and operation of a protection and advocacy system (P&A system) to monitor the care of individuals with mental illness and developmental disabilities ...
Beginning March 19, 2019, naltrexone drug products, including Vivitrol, dispensed pursuant to an outpatient prescription and indicated for the treatment of alcohol dependence or the prevention of relapse to opioid dependence must be reported to the Ohio Automated Rx Reporting System (OARRS) ...
