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…
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December 2023
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FDA Extends Comment Period on SIUU Draft Guidance
The United States Food and Drug Administration (FDA) has extended the comment period for comments on the revised draft guidance…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…
Provider Groups and Organizations Respond to Proposed Physician Fee…
In response to the Centers for Medicare and Medicaid Services’ (CMS) proposed 2024 Medicare Physician Fee Schedule, health…
DOJ Reaches $6.5 Million Settlement with Cardiologist Over Kickback…
Recently, the Department of Justice (DOJ) announced a $6.5 million settlement with Klaus Peter Rentrop and his medical practice,…
DOJ Announces Nearly $8.9 Million Self-Reported Stark Law Settlement
The United States Department of Justice (DOJ) recently announced a nearly $8.9 million settlement with Oliver Street Dermatology…
Genomic Health, Inc. Reaches $32.5 Million False Claims Act Settlement
Recently, Genomic Health, Inc., agreed to pay $32.5 million to resolve allegations that the company violated the False Claims Act…