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The Department of Health and Human Services Office of Inspector General (OIG) recently issued a report focused on what it characterized as concerning trends related to Medicare Part B claims submissions for skin substitutes, i.e., skin grafts. Skin substitutes have become a critical part of wound care and tissue regeneration and are increasingly a part of patient treatment plans. In the report, “Medicare Part B Payment Trends for Skin Substitutes Raise Major Concerns About Fraud, Waste, and Abuse,” the OIG highlights several billing and utilization patterns it views as consistent with fraud, waste, and abuse – signaling to the United States health care system that skin substitutes are now being closely scrutinized by the Department of Health and Human Services (HHS) and Department of Justice.Continue Reading “Skyrocketing” Medicare Part B Claims Submissions on Skin Substitutes

Laptop, stethoscope and doctor writing in notebook for research planning or medical tech innovation in hospital office. Healthcare medic worker, research strategy book notes and online communication

On June 9, 2025, Oregon Governor Tina Kotek signed into law Senate Bill 951 (the “2025 Act”).  Unlike California’s AB 3129, which was vetoed by California Governor Gavin Newsom in September 2024, the passage of the 2025 Act is the culmination of the state’s efforts to strengthen controls on health care transactions involving management services organizations (“MSOs”) and private equity investors.  The 2025 Act implements significant changes to Oregon’s existing corporate practice of medicine (“CPOM”) doctrine and materially affects existing arrangements between MSOs and the professional medical entities that they manage.  Significantly, the 2025 Act prohibits several material aspects of health care transactions that are standard in states that restrict CPOM. Continue Reading New Oregon Law Imposes Significant Corporate Practice of Medicine Restrictions

Laptop, stethoscope and doctor writing in notebook for research planning or medical tech innovation in hospital office. Healthcare medic worker, research strategy book notes and online communication

On May 12, 2025, President Donald J. Trump signed an executive order titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients.”  This executive order aims to lower the cost of prescription drugs for U.S. consumers by requiring drug manufacturers to sell their products to consumers at a most-favored-nation price through direct-to-consumer purchasing programs facilitated by the Secretary of Health and Human Services (“HHS”).  Under the proposed most-favored-nation approach, consumers would pay no more than the lowest price for a prescription drug sold by a drug manufacturer to customers in comparably developed nations. 

The executive order directs HHS to take steps to implement a most-favored-nation approach to prescription drug pricing.  This includes communicating most-favored-nation price targets to pharmaceutical manufacturers within 30 days.  If “significant progress” towards implementing the most-favored-nation approach is not made, the executive order directs HHS to, among other things, propose a rulemaking plan to impose most-favored-nation pricing.  The executive order does not specify a timeline for measuring “significant progress.” The executive order states that if drug manufacturers fail to implement most-favored-nation pricing, the Administration will take “additional aggressive action.”Continue Reading Trump Administration Issues Executive Order Aimed At Lowering Prescription Drug Pricing

The American Bar Association held its 40th Annual National Institute on White Collar Crime conference on March 5, 6, and 7, 2025, in Miami, Florida. The conference featured robust panel discussions with the federal and state judiciary, law enforcement officials, defense attorneys, corporate in-house counsel, and members of the academic community on a variety of topics. The conference speakers and panels also provided an update on litigation, judicial, and legislative developments. Notably, this conference differed from years past because most Department of Justice officials withdrew from participation days before the conference began.Continue Reading Government Agencies to Continue Pursuing Core Enforcement Initiatives and Other Highlights from the ABA 40th Annual National Institute on White Collar Crime

On February 25, 2025, President Donald J. Trump signed an executive order titled “Making America Healthy Again by Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information” (the “2025 Order”) aiming to provide increased transparency regarding the pricing of health care services.  This executive order builds upon a prior executive order issued during President Trump’s first term in June 2019 (the “2019 Order”) that required hospitals to disclose to consumers pricing information for certain “shoppable” health care items and services and maintain this pricing information in accessible, consumer-friendly formats.  The 2019 Order also mandated the establishment of rules requiring health care providers, health insurance issuers and self-insured group health plans to facilitate consumer access to information concerning expected out-of-pocket costs for health care items and services prior to receiving care.Continue Reading Trump Administration Issues Executive Order Mandating Implementation and Enforcement of Health Care Pricing Transparency

Laptop, stethoscope and doctor writing in notebook for research planning or medical tech innovation in hospital office. Healthcare medic worker, research strategy book notes and online communication

On September 28, 2024, California governor Gavin Newsom vetoed AB 3129, a bill that, among other things, would have required private equity firms and hedge funds to provide 90 days’ prior written notice to, and for some transactions, obtain consent from, the state attorney general prior to proceeding with certain health care transactions.

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Laptop, stethoscope and doctor writing in notebook for research planning or medical tech innovation in hospital office. Healthcare medic worker, research strategy book notes and online communication

Private equity investments in health care to be subject to increased oversight from federal and state regulators, including antitrust officials

Federal and state governmental regulation of health care transactions continues to increase rapidly.  At the federal level, there is increased focus on the role of private equity in health care and the perceived impact on access to care, quality of care and pricing.  At the same time, a growing number of states have passed and continue to propose legislation that increases state oversight of health care transactions.  As a result of this increase in regulatory scrutiny from federal and state regulators, parties interested in conducting health care transactions must consider various regulatory requirements and the factors regulators take into account when analyzing proposed health care transactions. Continue Reading Health Care Transactions Facing Increased Federal and State Regulatory Scrutiny

On April 26, 2024, the Federal Trade Commission (FTC) announced that it had finalized changes to the Health Breach Notification Rule (HBNR). These changes, which go into effect on June 25, 2024, are intended to modernize aspects of the HBNR such that the HBNR applies to entities not covered under the Health Insurance Portability and Accountability Act (HIPAA). The updated HBNR follows the FTC’s previously stated intention in a 2021 policy statement to broaden the interpretation of the HBNR to address the growing number of digital health applications, websites, and consumer-facing technology that were not subject to HIPAA. The scope of the finalized rule therefore aims to apply the HBNR to health care technology and digital health companies that obtain personal health records (PHR) and PHR identifiable health information.Continue Reading FTC Finalizes Broader Changes to the Health Breach Notification Rule

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On May 9, 2024, the Department of Justice (“DOJ”) announced the formation of the Antitrust Division’s Task Force on Health Care Monopolies and Collusion (“HCMC”). The HCMC “will guide the division’s enforcement strategy and policy approach in health care, including by facilitating policy advocacy, investigations and, where warranted, civil and criminal enforcement in health care markets.” Continue Reading DOJ Focus on Health Care Marches Forward with Formation of Task Force

On June 27, 2023, the Department of Health and Human Services (HHS), Office of Inspector General (OIG), posted a final rule on its website that amends the civil money penalty (CMP) regulations under the Information Blocking Rule. The final rule incorporates new CMP authority and increases the maximum penalties for certain CMP violations. The final rule was published to the Federal Register on July 3, 2023.Continue Reading HHS Final Rule Imposes New Civil Money Penalties for Information Blocking