On October 9, the Centers for Medicare & Medicaid Services (CMS) Innovation Center, issued a Request for Information (RFI) about the Innovation Center’s proposed Medicare $2 Drug List Model (the M2DL Model), which aims to test whether offering low-cost, clinically
Health Law
Analysis, commentary, and the latest developments in health care law and policy
The Health Law blog published by Crowell & Moring LLP focuses on legal developments and regulatory issues affecting the healthcare sector. It covers topics such as federal and state healthcare legislation, Medicaid funding restrictions, the Anti-Kickback Statute, information blocking under the 21st Century Cures Act, and disputes related to healthcare payment and reimbursement. The blog also addresses litigation trends, administrative rulemaking by health agencies, and compliance challenges faced by healthcare providers, insurers, and related entities. It provides analysis of court decisions, regulatory changes, and policy shifts impacting healthcare law and practice.
Latest from Health Law - Page 3
FDA Calls Out a Migraine TV Ad for Misleading Viewers
The FDA recently provided its opinion on a pharmaceutical television ad that should help other pharmaceutical companies in their own advertisements. The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) informed pharmaceutical company AbbVie…
The Anatomy of a Failed Qui Tam Case: Lessons from U.S v. Radiation Therapy Services
In the world of False Claims Act (“FCA”) litigation, the recent case United States ex rel. Robert C. O’Laughlin, M.D. v. Radiation Therapy Services, P.S.C., et al. serves as an important reminder of the need for concrete evidence when asserting…
Future Promises of Compliance with Federal Laws Cannot Form the Basis of a False Claims Act Violation
The United States District Court for the Eastern District of Michigan recently dismissed a False Claims Act (“FCA”) lawsuit brought against the City of Detroit. The core issue in United States ex rel. Lynn v. City of Detroit revolved around…
How much (information) is too much? Caselaw shines a light on avoiding privilege waiver.
United States of America v. Sutter Health is exemplary of the delicate balance courts must strike when dealing with attorney-client privilege. Here, the United States District Court for the Northern District of California denied the relator’s motion for determination as…
CMS Releases CY 2025 Medicare Physician Fee Schedule Proposed Rule
On July 10, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2025 Medicare Physician Fee Schedule Proposed Rule (2025 PFS Proposed Rule), which contains proposals to update PFS payment rates, improve payment for and access…
CMS Innovation Center Outlines Data Sharing Principles
By Allison Kwon
The Centers for Medicare & Medicaid Services (CMS) Innovation Center (the Innovation Center) published its data-sharing strategy, which seeks to further enable data sharing while ensuring proper security, risk management, and privacy obligations. The strategy outlines the Innovation Center’s approach…
The Intricacies of Qui Tam Actions and the Role of Government Dismissals
In the world of legal battles, few are as complex and as fraught with procedural intricacies as qui tam actions brought under the False Claims Act (“FCA”). The qui tam provision of the FCA allows private individuals, known as relators,…
CMS Notice of Funding Opportunity for the Innovation in Behavioral Health Model Open Until September 9, 2024
In January 2024, the Centers for Medicare and Medicaid Services (CMS) announced a new innovation care delivery model that seeks to bridge the gap between behavioral and physical health. The Innovation in Behavioral Health (IBH) Model aims to improve the…
FDA Publishes FAQs Around Its Recent Laboratory Developed Tests Final Rule
By Linda Malek & Jason Johnson
Linda Malek and Jason Johnson are partners in Crowell’s Health Care and Privacy & Cybersecurity Groups, and have a particular focus on advising clients on compliance issues related to clinical research and clinical trials. Stephen Holland is Senior Counsel in…