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
Heather Hoopes-Matthews and Matthew Roberts welcome Chuck Melendi, a seasoned healthcare consultant and former executive with decades of experience in pharmaceuticals, biotech, and medical devices. Chuck joins us to examine...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
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
The 340B Program has continued to undergo significant upheaval in 2024 that has the potential to bring about impactful changes to how the 340B Program operates moving forward. These developments have left 340B stakeholders in...more
Congress Negotiates Healthcare Extenders, Continues to Plan for 2025. Lawmakers continue negotiations to wrap up the 118th Congress and pass remaining must-do policies, including government funding, likely through a...more
A Quiet Healthcare Week on Capitol Hill. Congress was largely in recess this week, although the Senate returned briefly to complete consideration of a long-awaited foreign aid bill. Both chambers will return to session the...more
Although we are only two and a half months in, 2024 has already seen its fair share of impactful 340B developments on both the litigation and legislative fronts....more
The 340B Drug Pricing Program (the “Program”) allows certain healthcare providers (“covered entities”) to purchase pharmaceuticals from drug manufacturers at discounted rates. Some covered entities do not have an internal...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
340B covered entities may experience expanded access to contrast media, radiopharmaceuticals and other products at 340B prices in the coming months. Buried in the over 1,600 pages of the Consolidated Appropriations Act, 2023...more
Inflation Reduction Act Implementation: On Dec. 1, 2022, the Centers for Medicare & Medicaid Services (CMS) distributed an invitation addressed to “All Drug Manufacturers” announcing that CMS “will host monthly one-hour calls...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. This week's topics include: -...more
The U.S. House of Representatives is expected today to pass legislation passed by the U.S. Senate that will significantly alter the landscape for pharmaceutical pricing and reimbursement under the Medicare program for certain...more
Drug Pricing Initiatives: The Senate is expected to vote on a revised version of H.R. 5376 (the Build Back Better Act, or BBBA), now styled as the Inflation Reduction Act of 2022 (IRA). The House originally passed H.R. 5376...more
Drug Pricing Initiatives: Democrats renewed their efforts to pass drug pricing reform measures in the form of a revised H.R. 5376 (the Build Back Better Act, or BBBA). Democrats intend to adopt the BBBA as part of the budget...more
Drug Pricing Initiatives: Discussion continues regarding pathways to Senate passage of H.R. 5376 (the Build Back Better Act, or BBBA). Potential approaches include a reduced or modified version of the BBBA, although details...more
Among the drug pricing developments to watch in 2022, those at the top include legislation that would allow Medicare price negotiation and alter antitrust rules for the pharmaceutical industry, Federal Trade Commission...more
Drug Pricing Initiatives: The pathway to Senate passage of H.R. 5376 (the Build Back Better Act, or BBBA) is unclear, following Senator Joe Manchin’s withdrawal of his support for the measure. The BBBA is an approximately...more
Drug Pricing Initiatives: President Biden has indicated that a Senate vote on H.R. 5376 (the Build Back Better Act, or BBBA) will likely not occur until 2022. This follows conversations between President Biden and Senator Joe...more
Drug Pricing Initiatives: On Nov. 19, 2021, the House of Representatives passed H.R. 5376 (the Build Back Better Act, or BBBA), the approximately $2.2 trillion social safety net, climate, and tax bill that includes measures...more
Drug Pricing Initiatives: The fate of the reconciliation package that contains many of President Biden’s domestic policy initiatives, including with respect to drug pricing, remains in limbo as Democrats continue to debate...more
Drug Pricing Initiatives: Democrats are continuing to debate the reconciliation package that contains many of President Biden’s domestic policy initiatives, including with respect to drug pricing. The budget reconciliation...more
Drug Pricing Initiatives: On Aug. 24, 2021, the House of Representatives approved a $3.5 trillion budget framework, S. Cons. Res. 14, while also voting to advance the $1 trillion infrastructure bill. The deadline for the...more