The Office of Inspector General of the Department of Health and Human Services (OIG) has published an unfavorable advisory opinion involving a proposal by a Medicare Advantage Organization (MAO) offering Employer Group Waiver Plans (EGWPs) to share a percentage of its savings with certain groups to which it provides coverage.
With this advisory opinion (
The U.S. Department of Health and Human Services (HHS) has published its Plan for Promoting Responsible Use of Artificial Intelligence in Automated and Algorithmic Systems by State, Local, Tribal, and Territorial Governments in the Administration of Public Benefits (AI Plan for State and Local Governments). It shows the agency’s current thinking on managing risk from
The Department of Health and Human Services Office of Inspector General (“OIG”) recently issued a favorable advisory opinion regarding whether a proposed patient assistance program (“PAP”) would run afoul of Federal antifraud statutes.
Under the proposed PAP, a nonprofit organization would subsidize certain cost-sharing obligations for low-income Medicare enrollees who have diabetes and reside in
The use of artificial intelligence (AI) in research and development and the research and development of AI solutions themselves create far reaching legal and policy questions in the clinical research context.
In one of the latest installments of Reed Smith’s video series “AI explained”, Reed Smith attorneys Nancy Bonifant Halstead and Sarah Thompson Schick
The Department of Health and Human Services Office of Inspector General (OIG) recently issued two advisory opinions related to proposed arrangements offering financial assistance to individuals who receive gene therapy treatments. These arrangements were specifically targeted to patients who may suffer from infertility as a result of the treatments’ required chemotherapy-based fully myeloablative conditioning (Conditioning).
In its recently released 2025 proposed Medicare Physician Fee Schedule (“MPFS”), the Centers for Medicare & Medicaid Services (“CMS”) proposed two important modifications to the Medicare 60-day overpayment refund rule—a new “identified overpayment” standard and codification of a 6-month timeframe to investigate and quantify an overpayment.
A product of the Affordable Care Act, the 60-day
The Centers for Medicare & Medicaid Services (“CMS”) and the Office of the National Coordinator for Health Information Technology (“ONC”) have released a final rule establishing “disincentives” (i.e., penalties) for health care providers that participate in certain Medicare payment programs who have engaged in information blocking, as determined by the HHS Office of Inspector General
The fallout from last week’s Loper Bright/Relentless opinion by the U.S. Supreme Court that prospectively eliminated Chevron deference is still not fully clear, but Reed Smith has put together a Chevron Deference Resource Center where we will gather perspectives and events to help guide industry stakeholders through the new post-Chevron world.
The Resource Center will
The Supreme Court’s decision last week in the companion cases of Loper Bright Enterprises v. Raimondo and Relentless, Inc. v. Department of Commerce overturned the Court’s prior precedent in Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., and, in the process, upended 40 years of administrative law practice by requiring a court that is
The Department of Health and Human Services Office of Inspector General (“OIG”) recently issued a favorable advisory opinion that relates to whether two drug assistance programs would run afoul of the Federal anti-kickback statute (“AKS”).
In good news for the entity that requested the opinion, a United States corporate affiliate of a pharmaceutical manufacturer of
