Many allied health professionals are subject to state-level licensing requirements that can vary from jurisdiction-to-jurisdiction. What may be required in New York to hold a medical professional license may differ dramatically from what is required in Illinois or Texas, for
Life Sciences Perspectives
Life Sciences Perspectives, published by Goodwin Procter, focuses on legal and regulatory developments affecting the life sciences sector. The blog covers topics such as pharmaceutical and biotechnology transactions, regulatory compliance for drugs, biologics, medical devices, diagnostics, and laboratory testing. It also addresses antitrust issues, healthcare fraud enforcement, data privacy regulations like the EU Data Act, and FDA programs impacting drug development and approval. The blog provides updates on policy changes, enforcement trends, and strategic considerations for companies and investors operating in the life sciences and medtech industries.
Latest from Life Sciences Perspectives - Page 19
HHS, Labor, and Treasury Departments Defer Enforcement of Transparency in Coverage and No Surprises Act Requirements
The No Surprises Act and Transparency in Coverage final rules go into effect January 1, 2022. Implemented as Titles I and II of Division BB of the Consolidated Appropriations Act, these rules are intended to protect patients from surprise medical…
DOJ Recoups a total of $1.8 Billion from Health Care Fraud in 2020, Laboratory Recoupments Alone Account for Hundreds of Millions
By Anne Brendel
The Department of Justice (“DOJ”) has reported that in 2020, the government prosecuted dozens of laboratory owners and operators for anti-kickback related offenses responsible for hundreds of millions in alleged federal health care program loses. DOJ recouped a total of…
Alere Pays $198.75 Million to Settle False Claims for Allegedly Billing Medicare for Defective POC Devices, Not Charging Copays, and Sending Supplies to Deceased Patients
Alere Inc. and Alere San Diego Inc. (collectively “Alere”) have come under fire recently by the U.S. Department of Justice (“DOJ”) and other government agencies, agreeing to settle several rounds of accusations of False Claims Act violations for a total…
Patient Stakeholder Group Zeroes in on Medical Device Industry
By Matt Wetzel
In recent months, the Kaiser Health Network (part of the Kaiser Family Foundation) has issued three reports scrutinizing the orthopedic industry and its practices. Each report articulates the stakeholder group’s concerns over relationships among orthopedic and spinal surgeons, orthopedic implant…
SEC Approves NASDAQ Board Diversity Rules
On August 6, 2021, the U.S. Securities and Exchange Commission approved Nasdaq’s Board Diversity Rules (the “Rules”). The Rules require Nasdaq-listed companies to have or explain why they do not have at least two diverse directors. Companies are also required…
PhRMA Issues Updates to Longstanding Code, Addresses OIG’s Speaker Program Guidance
PhRMA, the pharmaceutical manufacturer trade association, announced on Fri. August 6 that it has revised its longstanding Code on Interactions with Health Care Professionals. The revisions, which relate to the Code’s treatment of speaker programs, track concerns in a…
Common GCP Bioresearch Monitoring Violations
The U.S. Food and Drug Administration’s (FDA’s) Office of Bioresearch Monitoring Operations (OBIMO) oversees domestic and foreign agency field inspections for clinical and non-clinical research. In particular, OBIMO manages the Bioresearch Monitoring (BIMO) Program which conducts onsite field inspections and…
Biden Executive Order Calls for Heightened Antitrust Scrutiny
On July 9, 2021, President Joe Biden announced a broad executive order (the “Order”). The Order is intended to boost what it characterizes as stagnant competition across the U.S. economy. The Order encourages federal antitrust agencies to “fairly and vigorously”…