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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
