Presidential Decree no. 229/20 of 8 September 2020 has been published and its aim is to reassess the measures imposed by Presidential Decree no. 142/20, considering the evolution of the epidemiological situation. The new decree renews most of the measures already in force, although it also eases some restrictions ...
The Federal Trade Commission’s increased focus on the antitrust implications of healthcare mergers and acquisitions has been widely publicized. While scrutiny has largely been directed toward hospital and health system transactions, a recent case in Nevada indicates that the FTC is now taking an interest in relatively small provider combinations in highly concentrated markets ...
The U.S. Fourth Circuit Court of Appeals has reversed a $44 million judgment against Tuomey Hospital in Sumter, South Carolina that arose from Tuomey’s employment arrangements with physicians that allegedly violated the federal Stark Law.1 The Stark Law prohibits hospitals from submitting claims to Medicare for designated health services that were referred by physicians with whom the hospital has a financial relationship, unless the relationship fits within an exception ...
The National Drug Agency Department of the Institute of Public Health, through exempt resolution No. 01746 of September 6, 2021, approved a guide to provide guidelines regarding the technological transfer of pharmaceutical production processes, necessary to obtain the authorization of a new manufacturer of a medicament, maintaining the previously authorized one ...
We previously reported that on March 30, 2017, Ohio Gov. John Kasich and the executive directors of Ohio’s health care licensing agencies announced new standards for prescribing opiates for acute pain ...
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 ...
Some West Virginia businesses have implemented COVID-19 vaccine mandates for employees. While the West Virginia COVID-19 Jobs Protection Act (W. Va. Code § 55-19-1 through § 55-19-9) protects people, businesses, and entities from some COVID-19 related claims, the Act does not address whether employees who suffer an injury from a COVID-19 vaccine mandated by their employers may bring a workers' compensation claim ...
It has been four months since the changes to 42 CFR Part 2, the confidentiality regulations that apply to all substance abuse treatment records, became effective. Ensure your policies and forms have been updated. The finalized changes to 42 CFR Part 2 by the Substance Abuse and Mental Health Services Administration (SAMHSA), an agency within the U.S. Department of Health and Human Services (HHS), took affect March 21, 2017 ...
On January 1, 2023, the Ohio Board of Nursing joined the multi-state Nurse Licensure Compact (“NLC”), allowing nurses who hold an Ohio nursing license to apply for a multi-state license. Ohio has joined at least 37 other states that participate in the multi-state license ...
On June 28, 2018, Attorney General Jeff Sessions and Department of Health and Human Services (HHS) Secretary Alex M. Azar III announced the ninth year of the national health care fraud takedown. The takedown resulted in the largest government action against health care fraud, which involved more than 600 defendants from over 50 federal districts. The targeted fraud schemes accounted for more than $2 billion in false billings ...
Don Stuart, a partner in Waller’s Tax Practice Group and current Chair of the Tax and Finance Practice Group of the American Health Lawyers Association (AHLA), and Kim Looney, partner in the firm’s Healthcare Compliance and Operations group, are authors on two chapters in the AHLA’s new publication The ACO Handbook: A Guide to Accountable Care Organizations, Second Edition ...
On May 10, 2016, the Québec Court of Appeal1 confirmed a Superior Court decision allowing an application for authorization of treatment and placement to a patient. The application had been brought by the Douglas Mental Health University Institute, commonly known as the Douglas, or the Douglas hospital ...
Sponsored wellness plans that include incentives to employees who voluntarily disclose personal health information as part of disability-related inquiries or medical examinations are in legal limbo after the EEOC removed the underlying rules from the Americans with Disabilities Act (“ADA”) and Genetic Information Nondiscrimination Act (“GINA”) ...
Decree-Law 36/2021, which amends Decree-Law 176/2006 of 30 August ("Medicines Statute"), was published on 19 May. The new Decree-Law introduces a ban on the advertising of discounts on the price of medicines subject to medical prescription that are reimbursed by the National Health Service ("NHS") or that contain narcotic or psychotropic substances ...
IP landscape While the world is in the grip of the deadly COVID-19 pandemic, the patenting of pharmaceutical and biological compositions and the launch of generic products is even more hotly debated than before, particularly in the world's developing and least-developed countries ...
On 17 May 2023, the Belgian Medicines Agency (FAMHP) announced that marketing authorisation holders (MAHs) have three years to comply with the prohibition of “negative formulations” on the packaging of medicinal products for human use. Such negative formulations include “gluten-free”, “lactose-free”, “ethanol-free” or “no colourings” ...
On 22 September 2023, the Royal Decree of 13 September 2023 establishing specific rules on the public procurement of biological medicinal products was published in the Belgian State Gazette (“Royal Decree”) ...
The President characterised this initiative as one necessary to counter "a pandemic of the unvaccinated", stating, "This is not about freedom or personal choice. It’s about protecting yourself and those around you" ...
The tsunami of consolidation activity in the dental services industry has created remarkable financial opportunities for dentists and investors. Primarily, these opportunities play out in the form of Dental Services Organizations formed by entrepreneurial dentists and/or private financial interests through the acquisition of established, profitable practices ...
Following up on the passage of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), the Department of Health and Human Services (HHS) recently issued a proposed rule to replace the Medicare sustainable growth rate (SGR) methodology which was repealed by MACRA. The proposed rule would implement the Merit-based Incentive Payment System (MIPS) to replace SGR and establish incentives for participation in Advanced Alternative Payment Models (Advanced APMs) ...
A number of events have occurred recently involving the Federal Trade Commission and healthcare entities. First, garnering the lead spotlight, the FTC began presenting its case in the U.S. District Court for Northern Illinois to enjoin a merger between Advocate Health and NorthShore University HealthSystem, two large Chicago-area health systems ...
2023 By Jarom B. Phipps, Esq. INTRODUCTION "Does it matter when an attorney completes the certificate of independent review for a gift to a care custodian in relation to when the dependent adult executes the transfer document? Getting the answer correct is important because a certificate that fails to comply with Probate Code section 21384 makes the donative transfer to the care custodian presumptively invalid ...
In the context of the current sanitary alert, several bills of law have been filed with Congress, seeking to regulate certain aspects associated to states of emergency and sanitary crises in particular.To such ends, the bills that stand out are:I. Bill prohibiting and penalizing price increases in the face of epidemics or pandemics:On Tuesday 17 March 2020, a bill was filed with the Lower Chamber (Newsletter 13 ...
Currently a large part of politicians, economists and lawyers are working hard to ensure that a recent Lithuania’s bank bankruptcy story would not repeat itself. Sometimes people still associate the term “bank” with instability, possibility to lose something or lack of transparent governing. Maybe this is the reason why there are no biobanks in Lithuanian which are widespread in the EU and other countries of the world ...
