False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Evolving AI Legislation: Federal Policies, Task Forces, and Proposed Laws — The Good Bot Podcast
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
Podcast — Drug Pricing: What’s in the New CMS Medicaid Final Rule?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 216: Patient Advocacy and Healthcare Policy Change with Melissa Horn of the Arthritis Foundation
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 214: Pharma Manufacturing in North Carolina with Ed Hernandez of Eli Lilly
Podcast — Drug Pricing: Takeaways From the Chicago Medicaid Drug Rebate Program Summit
Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry
Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
The Latest on Healthcare Enforcement
340B Drug Pricing Program Compliance
Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care
For the past several years, physicians and compounding pharmacies have stepped in to address critical patient access gaps during U.S. Food and Drug Administration (FDA) shortage declarations for semaglutide (Ozempic, Wegovy)...more
On January 17, 2025, the Drug Enforcement Administration (DEA) released the proposed rule, “Special Registrations for Telemedicine and Limited State Telemedicine Registrations.” The proposed rule marks a significant first...more
Weight loss clinics, telehealth companies, physicians, and pharmacies that have been prescribing or dispensing compounded GLP-1 medications must prepare for significant changes following the Food and Drug Administration’s...more
On January 9, 2025, the Texas Medical Board (TMB) implemented comprehensive changes to its rules, marking a significant shift in how medical spas, IV hydration clinics, and other healthcare facilities operate in Texas....more
In a significant ruling, the Second Circuit Court of Appeals recently expanded the scope of the Anti-Kickback Statute (AKS).The Court joined other circuit courts across the country in adopting, for the first time, the...more
At the end of December, the Second Circuit joined several other circuit courts in holding that a plaintiff adequately pleads an Anti-Kickback Statute (“AKS”) violation when she states with the requisite particularity that at...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
News Briefs - New FDA Guidelines Aim to Make TV Drug Ads Clearer, More Direct - The ever-present TV drug ads showing patients hiking, biking, or enjoying a day at the beach could soon have a different look, as new rules...more
The Centers for Medicare & Medicaid Services (CMS) on Nov. 1, 2024, released the calendar year (CY) 2025 Revisions to Payment Policies under the Physician Fee Schedule (MPFS) and Other Revisions to Medicare Part B...more
News Briefs - FTC Finalizes Providers' Reporting Rules Prior to M&A - The Federal Trade Commission finalized changes to a rule that will require healthcare companies, including hospitals and providers, to provide more...more
News Briefs - 75% of Hospitals Spending More on Tech to Boost Cybersecurity - Three-quarters of hospitals and health systems spent more on information technology last year and many will continue to do so, with greater focus...more
The House Ways and Means Committee has postponed discussions on several healthcare bills, including those related to physician pay, due to scheduling conflicts and disagreements over legislative language. This delay affects...more
News Briefs - House Committee Approves Telehealth Modernization Act of 2024 - A House committee voted to advance a bill that would extend telehealth flexibilities in Medicare for another two years. The legislation, called the...more
News Briefs - Physicians Responsible for Meeting CMS Information Blocking Rules - The Centers for Medicare & Medicaid Services and Office of the National Coordinator for Health Information Technology issued a final rule that...more
Federal law enforcement agencies, including the U.S. Drug Enforcement Administration (DEA), have amped up their investigations into the drug ketamine in recent years, likely in reaction to some high-profile overdose deaths....more
Knock, knock! If the Drug Enforcement Administration (DEA) is already at your door, it may be too late. Enforcement is on the rise, and the microscope is fixed on controlled substances. What can industry stakeholders do to...more
Healthcare fraud is an ever-growing constant in our economy. It is a battle that presents new and exponential challenges. The U.S. Department of Justice, the HHS-Office of Inspector general and State Attorneys’ General all...more
News Briefs - High Court Ruling on Chevron Doctrine Could Impact Health Credit - When the Supreme Court overturned the Chevron doctrine on June 28, it ended the mandate that federal courts should defer to federal agencies'...more
Healthcare enforcement is never quiet. There’s always something, or many things, going on, and compliance teams need to stay on top of the trends to ensure that their programs are staying ahead of the risks. To find out...more
News Briefs - Lawmakers Mull Lifting Restrictions on Physician-Owned Hospitals - Nearly 15 years ago, the construction of doctor-owned hospitals largely ground to a halt. But federal lawmakers now are considering bills that...more
News Briefs - Medicare Proposal Would Require Hospitals to Report Emissions - Hospitals for the first time could be asked to report their greenhouse gas emissions to the federal health department. A new Medicare proposal to...more
News Briefs - House Subcommittee Considering 15 Bills to Expand Telehealth - A major House subcommittee is considering 15 bills to expand access to telehealth services as the clock ticks on a Dec. 31 deadline on pandemic-era...more
Introduction - Polsinelli proudly introduces the Health Care Fraud and Abuse 2023 Year in Review, a comprehensive examination of the evolving landscape surrounding the False Claims Act (“FCA”) and fraud & abuse enforcement...more