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
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 4
CMS opens Notice of Funding Opportunity (NOFO) for the Transforming Maternal Health (TMaH) Model
In December 2023, the Centers for Medicare & Medicaid Services (CMS) announced a new model called the Transforming Maternal Health (TMaH) Model, the first of its kind to focus solely on improving maternal health care for Medicaid and Children’s Health…
CMS Releases CY 2025 Hospital OPPS Rule and ASC Proposed Rule
By Allison Kwon
On July 10, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2025 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) proposed rule (CY 2025 OPPS/ASC Proposed Rule), which contains proposals to update…
New federal guidelines for research security programs at covered institutions
On July 9, 2024, the Office of Science and Technology Policy (OSTP) released new guidance for federal research agencies that require certain research institutions (“covered institutions”) to certify that the institution has established and operates a research security program that…
Navigating the Attorney-Client Privilege Waiver Tightrope
The United States District Court for the District of Rhode Island cast a spotlight on the doctrine of implied waiver of attorney-client privilege in a recent False Claims Act (“FCA”) case. The case, United States of America ex rel. James…
What to Know about Gender-Affirming Care Following the Supreme Court’s Agreement to Review Sixth Circuit Decision
On Monday, June 24, 2024, the U.S. Supreme Court agreed to review last year’s Sixth Circuit decision that allowed Tennessee to keep its ban on gender-affirming care for minors in place. The Supreme Court will determine whether the Tennessee restrictions…
FDA Releases Revised Guidance on Promotional Labeling and Advertising Considerations of Biosimilar Products
By Allison Kwon & Linda Malek
On April 25, 2024, the U.S. Food and Drug Administration (FDA) issued and requested public comment on a revised draft guidance (Draft Guidance) providing recommendations related to promotional labeling and advertising that manufacturers, packers, and distributors (collectively “Firms”) should consider…
Healthcare Providers Who Engage in Information Blocking Will Face Disincentives Described in an HHS Final Rule
By Donna Reuter & Tai Williams
On June 24, 2024, the Department of Health and Human Services (“HHS”) released a final rule (“Disincentives Final Rule”) establishing disincentives for certain healthcare providers that have committed information blocking. The information blocking disincentives directly impact Medicare-enrolled healthcare providers or…
The Trusted Exchange Framework and Common Agreement (TEFCA) and State Data Exchange is Moving Forward in 2024
Health data exchange and interoperability have entered a new chapter in the U.S. In 2016, the 21st Century Cures Act (Cures Act) included a requirement that the Office of the National Coordinator for Health Information Technology (ONC) create a Trusted…
Settling False Claims Act Cases Involves More than Just Cutting a Check to DOJ
In late March 2023, Dr. Paul Koch, the former owner of a chain of Rhode Island ophthalmology practices, agreed to pay $1.1 million to the U.S. Attorney’s Office to settle false claims act allegations. This case arose from a qui tam complaint…