Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 248: Fighting Addiction and Expanding Access to Treatment with Sara Howe and Morgan Coyner of APNC
False Claims Act Insights - An FCA Perspective on Artificial Intelligence in the Healthcare Industry
Hospice Insights Podcast - Hospice Audit Updates: Hospices Fare Well in Federal Court
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 245: Using AI to Improve Radiology with Angela Adams of Inflo Health
Podcast - Regulating AI in Healthcare: The Road Ahead
Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
What’s in Your Operating Agreement? Legal Tips for Healthcare Providers
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 244: The Future of Independent Physician Practices with Ray Waldrup of The Leaders Rheum
Beyond the Bylaws: The Medical Staff Show - Need to Know: How to Manage Medical Staff Confidentiality and Privilege Protections
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 243: HIPAA Compliance and Potential Changes with Shannon Lipham of Maynard Nexsen
New Virginia "Workplace Violence" Definition and Healthcare Reporting Law: What's the Tea in L&E?
Hospice Insights Podcast - AI in Action: Exploring How AI Is Helping Hospices Do Things in New Ways
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 241: Fighting Nurse Burnout with Data-Driven Innovation with Dr. Ecoee Rooney of Indicator Sciences
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 240: Independent Practice In Dermatology with Dr. Darragh and Dr. Shuler of Carolina Dermatology
Podcast: Addressing Patient Complaints About Privacy Violations
False Claims Act Insights - How Payment Suspensions Can Impact FCA Litigation
Evolving AI Legislation: Federal Policies, Task Forces, and Proposed Laws — The Good Bot Podcast
Podcast - Innovations and Insights in the Palliative Care Space
ADA Compliance for Medical and Dental Practices: Responding to Inquiries and Investigations
False Claims Act Insights - Trump DOJ Sharpens Its Focus on Healthcare Fraud
FDA’s Office of Prescription Drug Promotion (OPDP) is active throughout each year issuing letters challenging promotional labeling they deem noncompliant. Any communication from FDA regarding a promotional claim they disagree...more
When was the last time you thought about “data on file” (“DOF”)? Probably not recently, but last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted an untitled letter (the...more
On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of...more
The U.S. Food and Drug Administration (FDA) has published final guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (SIUU...more
On January 7, 2025, FDA published a final guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products - Questions and Answers...more
Final Guidance Further Expands Scope of Permissible Proactive Off-Label Communications - On January 6, 2025, FDA finalized its guidance entitled Communications From Firms to Health Care Providers Regarding Scientific...more
On December 4, the U.S. Court of Appeals for the Seventh Circuit heard oral arguments in USA v. Mark Sorensen, case number 24-1557, and it is now taking under advisement a case that could have widespread effects as to what...more
U.S. health care attorneys, investors, and industry stakeholders are very familiar with the well-worn mantra that prescription drug and medical device companies are not allowed to “market” or “promote” their...more
Recently, the U.S. Food and Drug Administration (FDA) confirmed that it is investigating allegations that a 60 Minutes segment on the popular body weight loss drug Wegovy was actually an advertisement promoting the...more
Biosimilars are becoming increasingly important in healthcare as they offer a lower-cost alternative to biologic drugs, which can be expensive for patients, governments, and insurers. These biologic medicines, which are...more
Earlier this week, the Office of Inspector General OIG issued a Special Fraud Alert (Alert) on speaker programs by pharmaceutical and medical device companies in connection with the Federal Anti-Kickback Statute. In the...more
Novartis Pharmaceuticals Corporation (Novartis) recently entered into a civil settlement agreement with the Department of Justice (DOJ) to resolve allegations that the company paid health care practitioners (HCPs) who spoke...more
The Department of Justice (DOJ) announced this month that it obtained over $3 billion in settlements and judgments from civil fraud and false claims cases during the fiscal year ending September 30, 2019 (FY 2019). Of this...more
Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more
On September 4, 2019 the Department of Justice (DOJ) announced a $15.4 million settlement with pharmaceutical company Mallinckrodt ARD LLC (Mallinckrodt) to resolve alleged violations of the Anti-Kickback Statute (AKS) in two...more
When reformers look for ways to slash the ever-higher costs of American medical care, one line item should leap from television screens, print pages, and radio broadcasts: How does the nation benefit from medical enterprises...more
Back in late 2015, we blogged about the interesting twist in the $125 million Warner Chilcott settlement that a Massachusetts physician had been criminally charged with violating the Health Insurance Portability and...more
Drug manufacturers are once again facing new state limits on marketing and interactions with healthcare providers. Manufacturers should review the new laws and regulations carefully, consider how they might engage with the...more
As previously discussed, pharmaceutical sales representatives that conduct business in the City of Chicago will need to be licensed as of July 1, 2017. The Commissioner of the Chicago Department of Public Health (CDPH) and...more
Prompt Payment Discounts Not an Anti-Kickback Statute Violation - In United States of Am. et al. ex rel. Ruscher v. Omnicare, No. 15-20629, 2016 WL 6407128 (5th Cir. Oct. 28, 2016), the court of appeals affirmed summary...more
Earlier this week, the Chicago City Council joined other government agencies in imposing licensure and marketing requirements on pharmaceutical representatives when it unanimously approved licensing requirements for...more
Last week, the US Attorney’s Office in Boston announced that drug company Warner Chilcott agreed to plead guilty to health care fraud and pay $125 million to resolve criminal and civil liability arising out of allegations...more
As technology continues to evolve, so do the ways in which patients and healthcare providers obtain information pertaining to medical products regulated by the Food and Drug Administration (FDA). Thomas Abrams, Director of...more