Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 226: Orlando Health’s Expansions and Research with Amy Allen and Thibaut Van Marke of Orlando Health
Hospice Insights Podcast - Psychedelics and End of Life Care: Understanding the Legal Landscape
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 225: Cancer Care Access & Treatments with Dr. Sengar of Alabama Cancer Care
AGG Talks: Home Health & Hospice Podcast - Episode 9: The Impact of AI and Prior Authorizations on Home Health and Hospice
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 224: Healthcare Practice Operations with Steve McPheeters of HighFive Healthcare
Navigating Disputes Within Your Health Care Practice
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 223: Cybersecurity and Privacy Risks with Healthcare Vendors with Brandon Robinson of Maynard Nexsen
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Colorado AI Act — The Good Bot Podcast
Hospice Insights Podcast - Controlling the Narrative: A New Tactic for Auditors and ALJs
2025 Outlook: The Department of Health and Human Services Under the Second Trump Administration – Diagnosing Health Care
AGG Talks: Home Health & Hospice Podcast - Episode 8: Hospice Special Focus Program: Pumping the Brakes
RICO's Person/Enterprise Distinction - RICO Report Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 222: Hospital Response to Hurricane Helene with Jay Kirby of UNC Health Pardee
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
Compliance and Value-Based Care
AGG Talks: Healthcare Insights Podcast - Episode 8: What Healthcare Companies Need to Know When the Government Comes Knocking
Beyond the Bylaws: The Medical Staff Show - Medical Staff 101
Building a Solid HR Foundation in Healthcare Practices
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 221: Healthcare Investment Banking with Scott Davis of Provident Healthcare Partners
On February 25, 2025, President Trump signed an Executive Order directing federal agencies to “rapidly implement and enforce” federal healthcare price transparency regulations....more
On March 3, 2025, the U.S. Department of Health and Human Services (“HHS”) announced a new policy to reverse course on certain public notice and comment procedures. This marks a significant change to a process in place for...more
Now that the shortage of semaglutide injection products has been resolved, the Food and Drug Administration (FDA) will restrict third parties from compounding the drug. Our FDA/Food, Drug & Device and Health Care Groups have...more
Last week, the contract year (CY) 2026 Medicare Advantage (MA) and Part D final reg entered the clearance process at the Office of Management and Budget (OMB). As mentioned in a previous Regs & Eggs blog post, OMB’s review is...more
The litigator’s adage “it’s easy to plead, it’s hard to prove” once again came true in the long-running False Claims Act (FCA) case targeting Medicare Advantage (“MA”) plans operated by UnitedHealth (United). Eight years...more
The US Court of Appeals for the Federal Circuit affirmed a district court decision rejecting claims of a patent application directed to a dosing regimen for a cancer treatment, finding the claims to be obvious where the...more
On March 10, 2025, Health Secretary Robert F. Kennedy Jr. initiated a significant shift in the regulation of ultra-processed foods by directing the Food and Drug Administration (FDA) to revise the GRAS (Generally Recognized...more
On January 6, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) released a joint draft guidance document: Considerations for...more
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
On March 7, 2025, the FTC filed a complaint in federal court seeking to block GTCR BC Holdings, LLC, a Chicago private equity firm, from acquiring Surmodics, Inc. The FTC alleges that Surmodics is the leading provider of a...more
In a move with potentially significant implications for entities subject to the Affordable Care Act, the Department of Health and Human Services (HHS) has reversed course and now contends that Section 1557 of the Affordable...more
On February 25, 2025, President Donald Trump signed an executive order titled “Making America Healthy Again by Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information” (the “Order”), which...more
In connection with Royal Assent of the Pharmacare Act, we previously reported that the Minister of Health intended to negotiate bilateral agreements with provinces and territories to provide universal, single-payer,...more
United States Department of Health and Human Services (HHS) Secretary Kennedy recently directed the U.S. Food and Drug Administration (FDA) to consider rulemaking to revise its longstanding regulations and guidance governing...more
Yesterday, the U.S. Food and Drug Administration (FDA) updated its website to provide new information on data integrity concerns relating to medical devices. Over a year ago, FDA’s device center, the Center for Devices and...more
Completing a recent jurisprudential "hat trick,"* the Federal Circuit affirmed a District Court grant of a preliminary injunction against a biosimilar applicant for Regeneron's EYLEA biologic drug in Regeneron...more
On February 21, 2025, the Internal Revenue Service (“IRS”) released Notice 2025-15, providing guidance to employers and insurers regarding the alternative manner of furnishing certain health insurance coverage statements to...more
On episode 226, we welcome Thibaut van Marke and Amy Allen of Orlando Health, an award-winning network of community and specialty hospitals that recently expanded into Alabama. Thibaut and Amy discuss Orlando Health’s...more
On March 7, 2025, the FDA approved Celltrion’s Omlyclo® (omalizumab-igec), the first interchangeable biosimilar of Genentech’s Xolair® (omalizumab). Omlyclo® was approved for all of Xolair®’s approved indications, including...more
There are still several unsettled legal issues regarding the standards applicable to a False Claims Act (FCA) claim, such as the standard to prove causation when an FCA claim is based on a violation of the Anti-Kickback...more
For early-stage life sciences and health tech companies, raising capital is about more than demonstrating scientific promise. Investors are increasingly focused on regulatory preparedness, reimbursement strategy, and risk...more
In a precedential opinion issued on March 6, the Federal Circuit affirmed the US District Court for the Eastern District of Virginia that the claims in ImmunoGen’s US patent application 14/509,809 (“the ’809 application,”...more
GLP-1 receptor agonists (GLP-1RAs) were initially approved for diabetes treatment (e.g., Ozempic®) but have revolutionized weight management (e.g., Wegovy®) and are now being explored for treating a wide range of health...more
On March 3, 2025, the United States Department of Health and Human Services (“HHS”) issued a policy statement rescinding the Richardson Waiver, a policy in place since 1971 that required notice-and-comment rulemaking for...more
On March 5, 2025, one U.S. District Court ruled unequivocally in the Food & Drug Administration’s (FDA) favor in the case, Outsourcing Facilities Ass’n, et. al. v. U.S. Food and Drug Admin., et. al., 4:24-cv-0953-P, slip op.,...more