In a trend that sees increased regulation and scrutiny over healthcare-related mergers and acquisitions, the states of California, Illinois, and Minnesota have recently passed laws that require parties involved in such deals to notify state agencies and observe set waiting periods prior to closing. These sequences of regulations, akin to ‘Mini-HSR Acts’, are setting a…
Healthcare insurance provider Blue Cross Blue Shield of Arizona (AZ Blue) has recently disclosed that a security breach occurred at TMG Health, one of its vendors. This breach has affected the personal data of over 47,000 AZ Blue customers. The incident was discovered and first reported to the U.S. Department of Health and Human Services…
On August 29, 2023, the Health and Human Services (HHS) made a groundbreaking announcement as it selected the first set of drugs to be covered by the Medicare Part D for negotiation under President Biden’s Inflation Reduction Act of 2022 (IRA). This initiative is an integral part of the law signed into existence back in…
The Office of Patented Medicines and Liaison of Health Canada recently released its Statistical Report for the fiscal year ending March 31, 2023. It encompasses information related to Patented Medicines (Notice of Compliance) Regulations, Data Protection (C.08.004.1 of the Food and Drug Regulations), and Certificates of Supplementary Protection. This document, released on June 23, 2023,…
The U.S. state of California is currently navigating a crucial juncture in its legal and economic landscape, considering a set of proposed regulations that stand to significantly impact Mergers and Acquisitions (M&A) transactions within its jurisdiction. Five years from now, on or after April 1, 2024 to be precise, health care entities considering mergers or…
The Attorney General (AG) and federal regulators play pivotal roles in shaping legal landscapes across the U.S., making significant decisions that impact various sectors in significant ways. Here, we delve into several key stories highlighting areas where the influence of state and federal regulators is particularly salient. In Montana, the AG is playing a key…
Recently, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued an unfavorable advisory opinion. In this opinion, OIG declined to endorse a proposed arrangement involving an intraoperative neuromonitoring (“IONM”) company, hereafter named “the Requestor,” and various surgeons who perform procedures for which IONM is used. The Requestor and the surgeons planned…
In a fast-paced, technology-driven world, cybersecurity has emerged as an indispensable tool in every industry, and healthcare is no exception. The looming threat of potentially debilitating cyber attacks on health care systems highlights the need for strong cybersecurity measures. Not only do these attacks threaten national security, but they also pose a critical danger to…
The complexities of mental health law have increased exponentially in the wake of the COVID-19 pandemic, accentuating the pertinence of the Mental Health Parity and Addiction Equity Act (MHPAEA). MHPAEA, as you may be aware, mandates health care plans to offer mental health benefits, including coverage for substance use disorders (SUDs), in “parity” with medical…
Holland & Knight has recently extended its roster with the addition of Zubin Khambatta. In his new role as a partner, Khambatta will be a part of the healthcare regulatory and enforcement practice group, primarily serving from their Austin, Texas office, as outlined in the firm’s press release issued on Monday. Prior to joining Holland…
Blue Cross and Blue Shield of Illinois (BCBSIL) recently reported a data breach that occurred at HCSC Insurance Services Company. The incident took place on August 14, 2023, which BCBSIL then informed the Attorney General of Maine about it according to JD Supra. According to BCBSIL’s notice, the breach resulted in unauthorised access to consumers’…
On August 8, 2023, the Connecticut Supreme Court issued two significant opinions concerning the scope of immunity for health care workers and facilities in context of the COVID-19 pandemic. The cases in question were Mills v. Hartford HealthCare Corp. and Manginelli v. Regency House of Wallingford, Inc. Both suits examined Governor Ned Lamont’s Executive Order…
In a significant development for businesses operating within the medical and legal sectors in Florida, the Third District Court of Appeals has just affirmed a trial court’s decision in Mercury Indem. Co. of Am. v. Pan Am Diagnostic of Orlando, No. 3D22-161. The case concerns the allowance of a fully completed and executed CMS Form…
We live in a world that is increasingly dominated by Artificial Intelligence (AI), the technology expected to revolutionize almost every field, including the corporate legal sector. AI’s powerful predictive abilities have the potential to be a great boon, but ambiguity about how these algorithms operate (often referred to as the ‘black box’ conundrum) has stirred…
In an intriguing shift away from conventional thinking, there has been recent discussion concerning product liability lawsuits pertaining to surgical robots. While it’s common to envision liability suits from patients after unsuccessful operations, it’s considerably less common to consider potential claims from healthcare providers over injuries sustained while operating these technological wonders. Shook, Hardy &…
As telehealth continues to revolutionize the way healthcare is delivered, keeping pace with legal developments in this sector is imperative for legal professionals navigating the sector. Between August 15 to August 21, 2023, several significant legal advancements concerning telehealth were observed. A detailed review of these occurrences was provided by McDermott Will & Emery, which…
As reported on the JD Supra website, the North Carolina General Assembly did not convene for official business this week. The lack of action stems from ongoing budget negotiations among members of the Republican leadership and issues surrounding other bills currently on the docket. Lawmakers have publicly announced their intention to return for votes, possibly…
In a significant move for those working in the insurance, healthcare and legal industries, the U.S. federal government introduced new regulations and guidance on July 25, 2023. These changes are aimed at improving adherence to regulations outlined in the Mental Health Parity and Addiction Equity Act (MHPAEA). The requirements of the MHPAEA mandate insurance companies…
The impending open enrollment season for employee benefits in 2024, assisted by the recently published IRS guidance, signals a caution for employers worldwide. They are advised to ensure that the health plan offered to their employees is deemed affordable. As stated in the IRS Rev. Proc. 2023-29, there is a decrease in the new affordability…
As we approach a new academic year, parents across Pennsylvania are beginning to prepare for the upcoming school year. Shared legal custody, however, introduces another layer of considerations as reported by Obermayer Rebmann Maxwell & Hippel LLP. Shared legal custody refers to the joint responsibility of running a child’s life. Parents are tasked with agreeing…
In a recent legal event, a physician has been found guilty in a relatively unusual criminal Evaluation and Management (E/M) fraud trial. This case adds another layer of complexity in understanding E/M services, often described as “the core” of healthcare billing systems. The verdict has broader implications for medical and legal professionals worldwide, emphasizing the…
On Thursday, September 14, a notable meet-and-greet event is slated to take place at the SoFi Stadium in Inglewood, California. Lathrop GPM, a prominent full-service law firm, is hosting this event dubbed ‘LA Community Connections’ from 6:00 p.m. to 9:00 p.m. The event features a significant opportunity for legal professionals to network and familiarize themselves…
On August 18, the Office of Inspector General in the Department of Health and Human Services (“OIG”) issued Advisory Opinion 23-05. In it, the OIG expressed concern that a suggested arrangement falling under the purview of surgeries requiring intraoperative neuromonitoring (“IONM”) might be in violation of the Federal anti-kickback statute. This proposed arrangement involved the…
The New York State Office of the Medicaid Inspector General (OMIG) has recently proposed sweeping adjustments to the regulatory regulations presiding over compliance programs. These changes are set to impact entities receiving substantial Medicaid revenue. The modifications suggest an increase from a threshold of $500,000 to $1 million. As a refresher, every Medicaid provider in…
Next Monday marks the start of strike authorization votes by the 85,000 members of the Coalition of Kaiser Permanente Unions. Voting is expected to continue until September 13. The coalition, which accounts for half of Kaiser Permanente’s workforce, has raised concerns over the healthcare system’s unhurried attitude in addressing their grievances and offering an acceptable…