Proposed Rule Issued that Would Alter the No Surprises Act
Earlier this year, the United States Departments of Health and Human Services, Labor, and the Treasury (the Departments) together…
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HHS OIG Issues Advisory Opinion with Anti-Kickback Statute Reminders
Recently the United States Department of Health and Human Services Office of Inspector General (HHS OIG) issued an advisory…
HHS OIG Releases General Compliance Program Guidance
Recently, the United States Department of Health and Human Services Office of Inspector General (HHS OIG) published General…
Policy and Medicine Compliance Update December 2023 Issue:
Welcome to the December 2023 issue of Policy and Medicine Compliance Update, a monthly subscription-based publication tailored for…
Biden Administration Outlines Plan to Effectively Remove Patent Rights from…
The Biden Administration recently published a draft proposal to exercise “march-in” rights regarding generic options for patented…
Court Rules HRSA’s Proposed “Patient’ Definition Under the 340B Program is…
The United States District Court of South Carolina recently ruled that the proposed definition of “patient” under the 340B Drug…
FTC Challenges More than 100 Patents in the FDA Orange Book
Recently, the United States Federal Trade Commission (FTC) sent letters to medical device companies and drugmakers disputing the…
FDA Extends Comment Period on SIUU Draft Guidance
The United States Food and Drug Administration (FDA) has extended the comment period for comments on the revised draft guidance…
HHS OIG Starts to Enforce Information Blocking Penalties
On September 1, 2023, the United States Department of Health and Human Services Office of Inspector General (HHS OIG) started to…
Navigating the New Landscape: An Insight into the MATE Act DEA Requirements
The Medication Access and Training Expansion (MATE) Act, a pivotal legislation in the realm of opioid crisis management, was…