Compliance Program Effectiveness: Keep it Streamlined and Strategic
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 228: Designing & Manufacturing Auto-Injectors with Kimberlee Steele of SHL Medical
DOJ Addresses AI in Corporate Compliance Programs — The Good Bot Podcast
Beyond the Bylaws: The Medical Staff Show - The Role of Bylaws in Medical Staff Governance, Part I
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 227: What’s Next for America’s Life Sciences Industry with Arda Ural of EY
Taking the Pulse, A Health Care and Life Sciences Video Podcast | SCbio 2025 Preview with President & CEO James Chappell
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
On March 26, 2025, the FDA approved Fresenius Kabi’s denosumab biosimilars, CONEXXENCE® (denosumab-bnht) and BOMYNTRA® (denosumab-bnht), referencing Amgen’s PROLIA® and XGEVA®, respectively. These approvals make Fresenius...more
Three months into 2025, there appears to be no slowdown in the flood of privacy legislation being considered and enacted by both Congress and state legislatures. Since the California Consumer Privacy Protection Act was passed...more
As digital health companies blossom from ideas into reality, navigating state regulations on the corporate practice of medicine (CPOM) is typically one of the first and most crucial legal hurdles to clear if the digital...more
The Massachusetts Health Policy Commission (the HPC), an independent state agency that works to improve affordability of health care for residents of the Commonwealth, released Advance Guidance (before finalization of new...more
On March 27, the US Department of Health and Human Services (HHS) announced a significant restructuring initiative in accordance with President Trump’s Executive Order, “Implementing the President’s Department of Government...more
Vast changes are swiftly approaching regarding the efforts Workers’ Compensation practitioners must make in protecting Medicare’s interests in future medical settlements. The Centers for Medicare/Medicaid Services (CMS) has...more
Women who were diagnosed with meningioma brain tumors after using Depo-Provera birth control shots may be eligible to file a lawsuit and receive compensation for their illness....more
On Tuesday 11 March 2025, the European Commission published a legislative proposal for a Critical Medicines Act. The objective of this Act is to ensure stable supply and continuous availability of critical medicinal products,...more
Game On! 2026 Medicare Fee-for-Service Rulemaking Is About to Tip Off - It’s March, which means one thing for sports fans: the madness of the NCAA men’s and women’s basketball tournaments. However, to folks in the...more
The US Court of Appeals for the Federal Circuit found a Jepson claim unpatentable where the specification did not provide adequate written description for the portion of the claim purporting to recite what was already well...more
Dr. Martin Makary has been confirmed by the Senate as the next commissioner of the Food and Drug Administration (FDA). Dr. Makary is taking the helm at FDA during an unprecedented time for the agency, which has been subject...more
Addressing the calculation of patent term extensions (PTEs) under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit affirmed a district court decision that under the act the issue date of the original...more
At the 2025 American Bar Association (“ABA”) White Collar Crime Institute in Miami, industry veterans forecasted the new Trump Administration’s white collar objectives by examining trends during the first Trump presidency. In...more
Do plaintiffs’ experts get to put junk science before juries more often than their opinions are excluded? The answer is a resounding “probably.” Even in light of the December 2023 amendment to Federal Rule of Evidence and its...more
Trial lawyers, especially defense lawyers in the pharmaceutical and medical device arena, strive to ensure that “junk science” stays out of the courtroom. Unfortunately, that is often wishful thinking. When I spoke with an...more
March 26, 2025, marked a pivotal moment in the EU with the European Health Data Space Regulation, (EU) 2025/327 (“EHDS Regulation”), coming into force. The EHDS represents a transformative initiative by the European Union...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
In a significant development for fiscal intermediaries (FIs) and the Consumer Directed Personal Assistance Program (CDPAP), a New York Supreme Court Justice ruled on March 20, 2025, that the New York State Department of...more
KISS takes on a new meaning in this podcast: Keep it Streamlined & Strategic. Keeping it streamlined and strategic is also the topic of a session at the 2025 HCCA Compliance Institute...more
Drug development programs face unique challenges in demonstrating the safety and effectiveness of drugs for treating rare diseases. The FDA’s Accelerating Rare disease Cures (ARC) Program started the Learning and Education to...more
On March 17, 2025, a bipartisan group of senators introduced two bills intended to decrease the cost of prescription drugs. The sponsors include Chuck Grassley (R-Iowa), John Cornyn (R-Texas), Richard Blumenthal (D-Conn.),...more
On March 6, 2025, the National Institutes of Health (NIH) announced plans to centralize peer review of all applications for grants, cooperative agreements and research and development contracts within its Center for...more
Republican senators have introduced a Congressional Review Act resolution to nullify the rule that bans banks and credit unions from including medical debt on credit reports and generally prohibits the use of medical...more
On February 20, 2025, the ERISA Industry Committee (ERIC) announced that its legal counsel submitted a letter to the U.S. Departments of Labor (DOL), Health and Human Services (HHS) and Treasury, requesting a stay of...more
The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services has renewed its focus on two critical areas of HIPAA compliance: risk analysis and individual right of access. These enforcement...more