On December 17, 2024, the House Task Force on Artificial Intelligence (Task Force) released a highly-anticipated report titled, “Bipartisan House Task Force Report on Artificial Intelligence,” (the Report) which establishes guiding principles and issues recommendations to guide U.S. innovation in
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 2
FDA releases final guidance on 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review
On November 21st, the Food and Drug Administration (FDA) released final guidance for the 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review processes, which clarifies how the FDA will use third party review organizations (ROs)…
FDA Clarifies Enforcement Policy Around Communications of Scientific Information on Unapproved Uses of Drugs and Medical Devices
FDA approved drugs and medical devices are often studied further by sponsors and other firms to generate additional scientific information around other potential benefits and uses of those products. Providing the results of this additional scientific activity to health care…
FDA Proposes Framework to Assess AI Model Output Credibility to Support Regulatory Decision-Making
On January 7, 2025, in the last weeks of the Biden Administration and before President Trump returned to the White House, the Food and Drug Administration (FDA) issued draft guidance, entitled “Considerations for the Use of Artificial Intelligence To…
AMA’s CPT Editorial Panel Approves New Codes Covering Remote Patient Monitoring Services
By Allison Kwon & Sarah Cheney
On October 18, 2024, the American Medical Association’s (AMA’s) Current Procedural Terminology (CPT) Editorial Panel released a Summary of Panel Actions from its September 2024 Panel Meeting, which includes six new remote physiologic monitoring (RPM) and remote therapeutic monitoring (RTM)…
End of Year Regulations on Interoperability
Federal policy efforts to advance health data exchange and interoperability are continuing to change rapidly. The latest changes are the publication of two final rules by the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology…
RCE Issues Technical Guidance Governing TEFCA Exchange
By Allison Kwon
Federal policy efforts to advance health data exchange and interoperability through the Trusted Exchange Framework and Common Agreement (TEFCA) have advanced rapidly in the past several months. Since TEFCA became operational in December 2023, the seven designated Qualified Health Information…
HHS Releases Final Guidance for the Second Cycle of the Medicare Drug Price Negotiation Program
On October 2, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS) released final guidance outlining the process for the second cycle of negotiations through the Medicare Drug Price Negotiation Program.…
Stringent Requirements for Pleading Fraud Under Rule 9(b).
Dr. John Pepe and Dr. Richard Sherman (“Relators”), acting as whistleblowers, brought a qui tam action against Fresenius Medical Care Holdings, Fresenius Vascular Care, Inc., and Dr. Gregg Miller (“Defendants”). Relators’ complaint alleged that the Defendants engaged in fraudulent billing…
General Allegations Without Representative Examples Are Insufficient to Survive a Motion to Dismiss
The United States District Court for the Northern District of Indiana recently dismissed a case involving allegations of fraudulent Medicaid claims and self-referrals. The case, United States of America and State of Indiana ex rel. Bradley A. Stephens v. Nuclear…