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
In early August, the National Association of Attorneys General, led by its 2025 President, New Hampshire Attorney General John Formella, hosted the Presidential Initiative Summit in Portsmouth, New Hampshire. General...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
Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •Democratic AGs Oppose Washing Away Appliance Efficiency...more
Virginia AG Jason Miyares, along with a bipartisan coalition of eight other AGs, announced a $720 million settlement with eight opioid drug manufacturers to resolve allegations that they contributed to the opioid epidemic....more
PA’s Lottery Allowed to Allocate More Money to Player Payouts- Lawmakers passed legislation last week aimed at raising millions of more dollars for senior citizens by allowing the Pennsylvania Lottery to funnel more funds...more
The Department of Justice (DOJ) recently issued its annual Health Care Fraud Takedown results, announcing a record-breaking 324 defendants, including 96 doctors and licensed professionals, as well as more than $14.6 billion...more
The DOJ announced on June 30 an unprecedented Health Care Fraud Takedown resulting in criminal charges against 324 defendants (including 96 doctors, nurse practitioners, pharmacists and other licensed providers), with an...more
The Fourth Circuit Court of Appeals recently concluded that the U.S. Supreme Court’s decision in Coinbase Inc. v. Bielski is not limited to interlocutory appeals involving arbitration....more
Those waiting anxiously for the rules expanding the prescribing of buprenorphine via telemedicine and the controlled substance prescribing for patients at the Department of Veterans Affairs to officially go into effect will...more
On January 30, the U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. It is the first new type...more
On January 17, the Drug Enforcement Administration (DEA) and the U.S. Department of Health and Human Services (HHS) jointly published two final rules addressing the prescription of controlled substances via telemedicine in...more
New York AG Letitia James, along with a bipartisan coalition of 15 other state AGs and additional parties, has reached a settlement in principle with members of the Sackler family and Purdue Pharma, Inc., to resolve...more
The U.S. Drug Enforcement Agency (DEA) announced on Jan. 16, 2025, three new rules intended to implement patient protections and permanently extend certain COVID-era telemedicine prescription flexibilities. These new rules...more
On January 16, 2025, the Drug Enforcement Administration (DEA) announced two final rules and a proposed rule for telemedicine flexibilities. In 2024, the DEA issued a one-year extension of the COVID-era telemedicine...more
The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...more
The landscape of telemedicine in the United States is undergoing a profound transformation. On January 16, 2025, the Drug Enforcement Administration (DEA) unveiled a series of regulatory changes designed to expand and...more
McKinsey & Company, Inc., has entered into a deferred prosecution agreement (DPA) to resolve a federal criminal investigation into its advice to Purdue Pharma L.P. (Purdue) on how to increase sales of OxyContin, and a civil...more
A national class action on behalf of multiple Canadian governments to recover opioid epidemic healthcare costs simplifies the aggregation, prosecution, and determination of claims that span geographic boundaries. That is what...more
On November 1, 2024, CMS issued a rule finalizing changes to Medicare payments under the Physician Fee Schedule (PFS) and other Medicare Part B policies effective on or after January 1, 2025 (the Final Rule). Section 1848 of...more
Teva Pharmaceuticals Agrees to Pay $450 Million to Resolve FCA Claims - On October 10, the US Department of Justice (DOJ) announced that Teva Pharmaceuticals USA Inc. and Teva Neuroscience Inc. will pay $450 million to...more
On July 10, 2024, CMS issued a proposed rule that identifies and seeks public comments on a broad array of proposed changes to the Medicare Physician Fee Schedule (PFS) and Medicare Part B payments (the Proposed Rule) for...more
DOJ Announces Agreement With Rite Aid to Settle Allegations of Violating the FCA and CSA in Relation to Opioid Dispensing - On July 10, the US Department of Justice (DOJ) announced that Rite Aid Corporation and 10 of its...more
The Department of Justice announced one if its most aggressive and wide-ranging enforcement actions to date, a coordinated two-week operation spanning 32 federal districts. The orchestrated effort involved the FBI, HHS-OIG,...more
On June 20, 2024, the California Occupational Safety and Health Standards Board partially adopted Petition 602—a proposal to require employers to provide opioid overdose reversal medications (e.g., naloxone) at all worksites...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more