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…