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
The Inflation Reduction Act (IRA) changed how drugs are covered and reimbursed in Medicare. It is anticipated that this may lead to more restrictive formularies in drug plans....more
This is the third article in a series of summaries of insurance legislation from the 95th Arkansas General Assembly....more
News Briefs - High Court to Hear Case Challenging ACA Free Preventive Care - The Supreme Court is set to hear arguments in a case challenging a provision of the Affordable Care Act that requires private insurers to cover...more
Arkansas has become the first state in the nation to enact legislation, effective starting in 2026, prohibiting pharmacy benefit managers (PBM’s) from owning or operating actual pharmacies within the state. We take a look at...more
No legislation has garnered more attention in the life sciences industry in recent past than the so-called Drug Price Negotiation Program of the Inflation Reduction Act (the "Program"). ...more
Reconciliation Watch - Reports indicate that the Senate will move as soon as Wednesday to begin advancing a unified budget plan. The Senate hopes to be able to advance the budget resolution by having the two chambers...more
Evaluating current formulary access for the 25 drugs selected for Drug Price Negotiation in Medicare Part D shows several selected drugs have higher co-pays in 2025 relative to 2024 - Introduction - The Inflation Reduction...more
Update: The Government of Canada announced an agreement with the Yukon ($9.5 million over four years). The agreement text is available in the updated National pharmacare bilateral agreements resource....more
On February 27, 2025, the Government of Canada and Manitoba signed the first national pharmacare agreements under Canada’s Bill C-64, An Act respecting pharmacare (the “Pharmacare Act”), which received royal assent on October...more
Last year was a pivotal year for the pharmaceutical industry. Under the IRA’s Medicare Drug Price Negotiation Program (the Negotiation Program), the US government negotiated the prices of 10 selected high-expenditure,...more
A recent federal policy update and Quebec legislative changes are changing the healthcare landscape in Quebec, and may impact a variety of businesses operating in this sector....more
First Official Week of Trump 2.0 - President Trump officially began his second term yesterday. He briefly discussed healthcare in his first inaugural speech, committing to tackle chronic disease and keep children safe,...more
The rising cost of prescription drugs under Medicare continues to pose significant challenges for seniors, a population that relies heavily on consistent and affordable access to medications. This issue underscores broader...more
On December 10, 2024, the Centers for Medicare and Medicaid Services (CMS) released a Proposed Rule for revisions to the regulations governing the Medicare Advantage (MA) program, Medicare Prescription Benefit (Part D),...more
Congress Begins Disaster Relief Efforts, Continues Organizing for 119th Congress. In the aftermath of Hurricanes Helene and Milton, lawmakers are focused on funding an emergency supplemental disaster relief package. President...more
Updated November 18, 2024 – The Consolidated Appropriations Act (CAA), 2023 (Public Law 117-328), signed into law on December 29, 2022, extended certain key telehealth flexibilities instituted during the COVID-19 public...more
Welcome to our sixth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we take a look at the impact of AI when it comes to diverse health data, the FDA and AI medical devices, Virginia's...more
The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more
Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more
The Florida Regular Legislative Session began on January 9, 2024, and ended on March 8, 2024. Below is a summary of relevant health care laws that will be effective July 1, 2024, if they are approved by Governor DeSantis....more
Last week, McDermott+Consulting launched an election 2024 resource page, where you can find a 2024 health policy outlook and other insights into the November election. While regulations aren’t necessarily top-of-mind when...more
Pharmacy Benefit Managers (PBMs) take note! Under Florida’s new Prescription Drug Reform Act, PBMs must be licensed as an insurance administrator (also known as a third-party administrator, or TPA). Under this new law, any...more
In 2024, Medicare will, for the first time, have authority under the Inflation Reduction Act passed in 2022 to negotiate drug prices with pharmaceutical manufacturers. On August 29, the Centers for Medicare and Medicaid...more
On August 29, 2023, the Centers for Medicare & Medicaid Services (CMS) announced the ten (10) Medicare Part D drugs selected for the first round of negotiations of the Medicare Drug Price Negotiation Program (Program)—a few...more
This week marks the one-year anniversary since the enactment of the Inflation Reduction Act (IRA), which included sweeping reforms empowering the Secretary of Health and Human Services (HHS) to set prices for certain...more