The ever-changing healthcare policy landscape will witness at the federal level regulatory changes driven by the need to transform healthcare delivery, quality and innovation. Looking forward in 2024, this summary examines a number of healthcare innovation topics that have seen
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 6
Monumental Reduction in FCA Damages Based on Excessive Fines Clause
In a recent landmark decision, the United States District Court for the District of Minnesota dramatically reduced the damages and penalties awarded in a major False Claims Act (“FCA”) case. United States of America ex rel. Kipp Fesenmaier v. The…
CMS Innovation Center Announces Sickle Cell Disease Focus under Cell and Gene Therapy Access Model
By Allison Kwon
On January 30, the Centers for Medicare & Medicaid Services’ (CMS’) Innovation Center announced that sickle cell disease (SCD) will be the first focus of the Cell and Gene Therapy (CGT) Access Model, a model for eligible states and pharmaceutical manufacturers…
CMS Finalizes CY 2024 Medicare Physician Fee Schedule Rule
On November 2, 2023, the Centers for Medicare & Medicaid Services (“CMS”) released the calendar year (“CY”) 2024 Physician Fee Schedule (PFS) Final Rule (“CY 2024 PFS Final Rule”). The final rule reflects CMS’ broader strategy to promote…
The Complexities of Assessing Damages in FCA Cases
Calculating and predicting damages in a False Claims Act (“FCA”) case can be a daunting task for the most seasoned FCA practitioners. In fact, even judges presiding over years of litigation and weeks of trial can get it wrong by…
ONC Releases Final Rule on Information Blocking and Health IT Certification Program Updates, Including Requirements Related to AI
On December 13, 2023, the U.S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health Information Technology (ONC) released the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final…
FDA Releases Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles
On October 24, 2023, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the U.K.’s Medicines and Healthcare products Regulatory Agency (“MHRA”) jointly released a publication identifying five guiding principles for predetermined change control plans (“PCCP”) for machine learning-enabled…
FDA Issues Final Guidance on Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring
On October 19, 2023, the U.S. Food and Drug Administration (FDA) issued final guidance entitled, “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring,” (the Final Guidance) to provide clarification on its enforcement policies and premarket review…
FDA Releases Guidance on Digital Health Technologies for Clinical Investigations
On December 22, 2023, FDA issued final guidance–Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. This final guidance is aimed at sponsors and others who may be involved in remote data acquisition for clinical trials to…
OIG Issues Updated General Compliance Program Guidance: Overview of Key Elements & Changes
The Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) published the General Compliance Program Guidance (GCPG) on November 6, 2023. The GCPG provides updated descriptions of the seven elements of an effective…