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…
In recent developments around the 340B Drug Discount Program, a key prescription drug initiative in the United States, 23 attorneys general (AGs) from across party lines have raised pertinent concerns and recommendations. The cohort, comprising 21 Democrats and 2 Republicans, issued a letter in response to a request for information relayed by a bipartisan group…
The legal world continues to be a dynamic landscape, wherein corporations, as much as their individual employees, are called out into court for settlement of various disputes. As such, there are significant developments that may be of interest to legal professionals in the corporate sector. Consider the case of President Trump, who continues to assert…
Healthcare organizations today often grapple with a significant snafu of the digital age: online reviews. These public testimonials, for better or for worse, have a massive influence on a healthcare organization’s reputation. Even a small number of dissatisfied patients can cause substantial harm with negative comments posted on social media and customer review platforms like…
Envision Healthcare Corp., along with its wholly-owned subsidiaries, has recently filed for voluntary Chapter 11 petitions at the U.S. Bankruptcy Court for the Southern District of Texas. This information is detailed in the case documented under In re: Envision Healthcare Corp., Docket No. 4:23-bk-90342 (Bankr. S.D. Tex. May 15, 2023). Envision is known for being…
The California Applicants’ Attorneys Association (CAAA) consistently holds its conferences twice a year, an engaging event where important discussions take place concerning adjustments in Workers’ Compensation Law and the development of new strategies to enhance recovery for client interests. Not straying from the tradition, the 2023 Winter CAAA and Summer conferences proffered insightful discussions on…
On July 25, 2023, Sens. Chuck Grassley (R-IA), Dick Durbin (D-IL), John Kennedy (R-LA), and Roger Wicker (R-MS) introduced the False Claims Amendments Act of 2023. This development was reported by the reputable law firm, Arnall Golden Gregory LLP. The proposed amendment to the False Claims Act does not eliminate the requirement that the alleged…
As we approach the start of a new academic year, many parents of recent high school graduates find themselves overwhelmed with the preparations for sending their child off to college. Often, these preparations are focused on gathering dorm room essentials and emotionally coping with the temporary loss of a household member. However, another crucial aspect…
The Department of Health and Human Services (HHS), Office of Inspector General (OIG), announced on June 27, 2023, an amendment to the civil money penalty (CMP) regulations under the Information Blocking Rule. This significant development, lodged on the OIG’s official website, incorporates new CMP authority and elevates the maximum penalties associated with specific CMP violations….
In a recent ruling by the U.S. Court of Appeals for the Federal Circuit, it has been determined that a claim to a treatment method for pulmonary hypertension cannot be invalidated for lacking enablement or written description. The case at hand is United Therapeutics Corporation v. Liquidia Technologies, Inc. The court declared that the claims,…
Compliance with the Mental Health Parity and Addiction Equity Act (MHPAEA) remains a pivotal focus for several US Federal Agencies. This comes to light following the annual report recently presented to the U.S. Congress by the U.S. Department of Labor (DOL), the U.S. Department of Health and Human Services (HHS), and the U.S. Department of…
In a world where businesses generate and handle enormous volumes of data, privacy law compliance has become more critical than ever. This is especially true for companies operating in heavily regulated sectors such as financial services and healthcare. An ever-increasing complexity within the patchwork of state privacy laws has added another layer to this burgeoning…
The US Department of Health and Human Services Office of Inspector General (HHS-OIG) recently issued a final ruling implementing its mandate under the 21st Century Cures Act to investigate allegations of information blocking among health IT developers and health information networks/exchanges (HIN/HIEs). Violations of this prohibition can lead to penalties as steep as $1 million…
On July 13, NextGen Healthcare Inc., a renowned electronic health record (EHR) software vendor, settled its issues with the Department of Justice (DOJ), and the Office of Inspector General of the Department of Health and Human Services (HHS) in quite a remarkable manner. The agreement, covering the resolve of alleged False Claims Act and Anti-Kickback…
As the landscape of health care continues to evolve rapidly, the future of healthcare is arriving sooner than we imagined. Based on a podcast series featuring conversations with Dr. Ben Locwin and Scott Endicott, significant current trends are emerging that are fundamentally shifting the industry. The series dives into a range of critical topics including…
As legal practitioners in the global business arena, the analysis of Fair Market Value (FMV) is often an area demanding utmost attention and precision. FMV, predominantly an issue of significance in regulatory compliance and compensation agreements concerning the healthcare sector, prompts a meticulous investigation of its defensibility. The following discussion draws on Health Care Compliance…