Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 246: The Next Generation of Treatment for Alzheimer's and Parkinson’s with Neal Goodwin and Pawel Krysiak of Jaya Bio
AI Today in 5: August 11, 2025, The ACHILLES Project Episode
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Key Discovery Points: BYOD Case Law Covering Subpoenas and Employee Handbooks
Daily Compliance News: June 23, 2025, The Is Walmart Cool Edition
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Unexpected Paths to IP Law with Dan Young and Colin White
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle O’Connell of MassBio
Compliance Program Effectiveness: Keep it Streamlined and Strategic
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
Podcast — The Growth Rocketship: How BridgeBio’s Hub and Spoke Portfolio Strategy Set the Market for the Future of Biotech — Then, Now, and What’s Next?
On August 6, 2025, the U.S. Court of Appeals for the Second Circuit issued an opinion allowing a case challenging drug pricing changes to proceed. The case, an antitrust action brought by health centers against certain...more
Grounded in the OIG’s General Compliance Program Guidance and DOJ’s Evaluation of Corporate Compliance Programs, our immersive, three-and-a-half-day, classroom-style Healthcare Basic Compliance Academy equips compliance...more
Heath care fraud remains a top priority for the DOJ. This year’s National Health Care Fraud Takedown was the biggest in United States history, resulting in the prosecution of 324 defendants in connection with over $14.6...more
We have seen plainly what happens when disasters interrupt domestic healthcare supply chains: from N-95 masks to saline, our healthcare system has struggled in the face of hurricanes and a pandemic, as just two recent...more
News Briefs - Physician Productivity Rising, But Reimbursement Isn't -Physicians are working more than ever, but reimbursement isn't rising in tandem. It's a worrying mismatch that could translate into access problems for...more
As previously discussed in our prior blog post, on August 1, 2025, the Department of Health and Human Services (HHS) issued a Notice announcing a much-anticipated 340B Rebate Model Pilot Program (Pilot Program). Subsequently,...more
News Briefs - Over 75% of Health Organizations Targeted by Ransomware Over Year - More than three-quarters of healthcare survey respondents said their organizations were targeted by ransomware in the past 12 months, and 53...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
Structure & Timing of the Pilot Program - On August 1, 2025, the Health Resources and Services Administration (HRSA), administrator of the 340B Drug Pricing Program, announced its voluntary 340B Rebate Model Pilot Program in...more
On July 31, 2025, the U.S. Department of Health and Human Services (HHS) announced that it will conduct a pilot program testing out a rebate model for 340B drug purchases. Under the program, drug manufacturers will be allowed...more
On July 16, 2025, the U.S. Department of Health and Human Services’ (HHS) Centers for Medicare & Medicaid Services (CMS) published its CY 2026 Medicare Physician Fee Schedule (PFS) Proposed Rule, which includes a sweeping...more
On July 31, 2025, notice was published in the Federal Register by the Health Resources and Services Administration (“HRSA”) of a “340B Rebate Model Pilot Program” (“340B Pilot Program”). The 340B Pilot Program’s stated...more
On July 16, 49 attorneys general (AGs) announced that they joined a $202 million settlement with Gilead Sciences, Inc. (Gilead). Previously announced by the Department of Justice in April, the settlement resolved allegations...more
The healthcare mergers and acquisitions (M&A) market remained active in Q2 2025, with several sectors including physician practice management (PPM), clinical research, and digital health experiencing continued investment and...more
Overview - The Centers for Medicare & Medicaid Services (“CMS”) has finalized and proposed several significant changes affecting both site neutrality in Medicare payments and the 340B Drug Pricing Program. These changes...more
Trending in Telehealth highlights monthly state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and...more
While federal funding for addiction treatment programs and research is being cut, more than $50 billion is being distributed to state and local programs from opioid-related lawsuits. There is great debate on the use of these...more
The U.S. Department of Health and Human Services (HHS) and the Department of Justice (DOJ) have jointly announced the launch of a reinvigorated DOJ-HHS False Claims Act Working Group aimed at enhancing interagency...more
The Department of Justice and the Department of Health and Human Services announced the reinvigoration of a False Claims Act (“FCA”) Working Group, a joint effort between the two agencies. ...more
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more
Pioneer Construction Company, Inc., Eastern Alliance Insurance Company, and employers Alliance, Inc. v. Insight Pharmaceuticals, LLC d/b/a Insight Pharmacy; No. 867 C.D. 2022; filed May 12, 2025; Judge Covey - A workers’...more
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 June 11, 2025, Assistant Attorney General Brett A. Shumate issued an internal memorandum (the “Shumate memo”) to all Civil Division employees of the U.S. Department of Justice (“DOJ”), describing the Division’s enforcement...more