The Drug Enforcement Administration (DEA) recently announced plans to host two public listening sessions on September 12 and 13, 2023. The purpose of these sessions is to gather further input on the practice of telemedicine, with an emphasis on the remote prescribing of controlled substances without an in-person evaluation of patients beforehand. The meetings will…
The week of July 25th to 31st, 2023, was marked with significant developments in telehealth. Various states presented legislative and regulatory developments that greatly impact healthcare providers, telemedicine companies, pharmacies, and digital health. These developments have far-reaching effects on entities delivering and facilitating the delivery of virtual care. Such policies and advancements can shape the…
The USPTO recently published an updated report on Inter Partes Review (IPR) and Post Grant Review (PGR) proceedings, which spotlighted the Orange Book or biologic patents. These findings incorporate data until March 31, 2023, offering a revealing look into this crucial patent litigation realm. Significant for stakeholders navigating this intricate field are marked variances in…
The Centers for Medicare & Medicaid Services (CMS) has recently released the Skilled Nursing Facilities (SNF) and Inpatient Prospective Payment System (IPPS) final rules, signaling new alterations to healthcare regulations. This action by CMS is part of a broader initiative to review and modify health care rules to accommodate evolving health scenarios and market needs….
On July 25, 2023, the U.S. Department of Health and Human Services (HHS), the Department of Labor, and the Department of the Treasury (collectively referred to as “the Departments”) collectively issued a set of proposed rules regarding the compliance of health plans and issuers with mental health parity requirements. The Departments also published a related…
The U.S. Attorney’s Office for New Jersey recently unveiled that Alexander Schleider, a resident of Lakewood, has admitted to wire fraud and conspiracy to commit healthcare fraud. The fraudulent scheme was centered on durable medical equipment (DME). Schleider pleaded guilty to his actions as part of a large-scale kickback plot, which resulted in massive losses…
In a recent development, Texas Clinical Laboratory, BestCare Laboratory Services LLC, and its founder, have agreed to pay $5.7 million to settle a 2018 False Claims Act (FCA) judgement. Arising under the Department of Justice’s ability-to-pay policy, the judgement was imposed based on assertions of fraudulent claims to federal healthcare programs. This resolution seems poised…
Over the past year, the Federal Trade Commission (FTC)’s actions have indicated its increased role in health privacy enforcement. The FTC has strategically led enforcement actions, policy statements, and regulatory changes aimed at scrutinizing the misuse of consumer health data and related types of information by companies. This has positioned the FTC as one of…
In the rapidly evolving era of digital health, many medical practitioners and healthcare providers are turning to artificial intelligence tools to streamline their operations and enhance patient care. Among these AI developments, ChatGPT, an advanced conversational AI developed by OpenAI, has been gaining attention for its potential application in the healthcare sector. ChatGPT’s impressive ability…
In a significant development, a judge has dismissed the second bankruptcy case filed by Johnson & Johnson over its talcum baby powder liabilities. Despite expressing some reservations, U.S. Bankruptcy Judge Michael Kaplan in Trenton, New Jersey, ruled in favor of cancer victims who argued that the new bankruptcy case was devoid of goodwill. Johnson &…
In a somewhat unexpected twist within the law industry, associates at an employment law firm have decided to form a union. This move signals a growing trend among legal professionals who are seeking more control over their working conditions and pay. While it is quite common for employees in sectors such as education, healthcare, and…
In a recent development in the healthcare and life sciences private equity space, WM Partners has completed the acquisition of Allergy Research Group from Kikkoman Corp. This transaction marks a significant venture for WM Partners into the thriving sector of healthcare. As reported by JD Supra, the details of the transaction have not been fully…
Recent developments in Pennsylvania law place a new layer of responsibility on medical providers and facilities in relation to voluntary inpatient examination and treatment. These entities could potentially face legal liability if they refuse to render requested healthcare services to a person who willingly presents themselves for examination and treatment, particularly when such refusal amounts…
In its August 4, 2023 report, McDermottPlus Consulting updated on a variety of regulatory developments. Among the highlights, we see initiatives from Centers for Medicare & Medicaid Services (CMS) including the final FY 2024 Inpatient Prospective Payment System (IPPS) rule, a newly proposed Medicare Dementia Care Model, as well as the latest 2024 Medicare Part…
Artificial intelligence (AI) is closely watched by stakeholders in healthcare and life sciences. The ongoing development of AI-enabled solutions is bringing radical transformations in these sectors – impacting drug discovery, disease diagnosis, clinical trials, and precision medicine. Consequently, life science firms are increasingly investing in AI tools, as reported by Law360. When life sciences and…
The Federal Trade Commission (FTC) has submitted a notice of proposed rulemaking, with the objective of expanding the Health Breach Notification Rule (HBNR) to include most health apps and similar technologies that are not governed by HIPAA (Health Insurance Portability and Accountability Act). The HBNR amendment proposition follows an effort to formalize the FTC’s Statement…
The Joint Commission, a nationally recognized body providing accreditation for healthcare organizations, has recently taken significant steps to reduce burdensome regulations. In its latest modifications, the commission will eliminate or consolidate over 200 accreditation standards across many of its programs. This marks the second major tranche of standards reduction employed by The Joint Commission. This…
The Centers for Medicare and Medicaid Services (CMS) has issued a final rule that introduces revisions to Medicare policies and rates intended for the Inpatient Psychiatric Facility (IPF) Prospective Payment System (PPS) for fiscal year (FY) 2024. This decision comes in light of an increasing demand for changes in healthcare policies amidst shifting societal needs….
In a recent legal development, the United States Court of Appeals for the Second Circuit has affirmed the exclusion of purported autism science, aiming to discredit its usage in lawsuits connected to this neurological disorder. The case in question, Daniels-Feasel v. Forest Pharms., Inc., 2023 U.S. App. LEXIS 19448 (2d Cir. July 28, 2023), seems…
Law firms are typically owned by lawyers – a fact I found myself grateful for after hearing a recent podcast discussing the influence that private equity ownership has begun to wield over the healthcare profession. As it turns out, private equity firms have been increasingly buying up healthcare practices, resulting in a drastic shift in…
On July 3, 2023, the Office of Inspector General (OIG), a part of the US Department of Health and Human Services, put into motion a final rule outlining the use of Civil Monetary Penalties (CMP) against unlawful acts of information blocking. Implemented under the OIG’s jurisdiction, this rule authorizes CMPs of up to $1 million…
On August 1, 2023, the Centers for Medicare & Medicaid Services (CMS) announced the fiscal year 2024 Inpatient Prospective Payment System (IPPS) final rule. This ruling represents essential adjustments to Medicare payment policies. In addition, it extends vital enhancements to quality reporting programs relevant to inpatient hospital services. This latest ruling is consistent with key…
In exploring the future of healthcare, Thomas Fox, a Compliance Evangelist, has conducted a series of podcast interviews with Dr. Ben Locwin and Scott Endicott. Throughout his five-part series, Fox has addressed diverse themes such as gene and cell therapy, proper use and misuse of statistics, the evolution of healthcare from the times of Hippocrates…
In a notable development, the U.S. Departments of the Treasury, Labor, and Health and Human Services have recently put forth anticipated proposed regulations under the Mental Health Parity and Addiction Equity Act (MHPAEA). This regulatory proposal aims to secure parity for the accessibility of mental health or substance use disorder (MH/SUD) benefits with those of…
Earlier this year, we reported on the establishment of California’s new Office of Health Care Affordability (OHCA). In keeping with its mission, OHCA has recently introduced proposals in the form of regulations that provide detailed insights into their authority over various transactions in the healthcare space. These regulations are available for public viewing on the…