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
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
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
The giant firms that track trends for big businesses have glum news for all of us: Health care costs are spiking anew this year. The rise, one consultancy predicts, will be the highest in 13 years....more
Among the many rescissions of Biden administration Executive Orders, signed by President Trump on his administration’s first day, was a rescission of an Executive Order that encouraged Medicare to lower drug costs and makes...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
House Committees Organize, Senate Committees Begin Nomination Hearings. House healthcare committees held organizing meetings and announced subcommittee assignments, while Senate committees held nomination hearings for...more
Over the last two months, there has been a steady influx of regulatory and legislative efforts regarding drug pricing and the pharmacy industry. To streamline your review, we summarize below a few noteworthy developments that...more
While the sweltering roil of temporary regulatory changes related to the COVID-19 pandemic may have cooled and the initial burst of SECURE 2.0 steam begins to dissipate, sponsors of employee benefit plans should keep their...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
The top legal issues in 2024 for the life sciences field reflect the complex and changing legal landscape that the industry is navigating, encompassing drug pricing, regulatory challenges, and broader societal and governance...more
Last month, in HIV and Hepatitis Policy Institute et al v. HHS, Case No. 1:22-cv-02604-JDB (D.C. Sept. 29, 2034), the U.S. District Court for the District of Columbia struck down a Department of Health and Human Services...more
Today, Thursday, March 9, President Biden unveiled his Fiscal Year (FY) 2024 budget request, the third of his presidency. The $6.1 trillion proposal calls for $1.9 trillion in discretionary spending and $4.2 trillion in...more
After almost a year of negotiations among congressional Democrats and the White House, the Inflation Reduction Act of 2022 (IRA) was signed into law by President Biden on August 16, 2022. It passed in the US Senate by a vote...more
On August 16, President Biden signed into law the Inflation Reduction Act of 2022 (P.L. 117-169; the “Act”). Although the Act differs considerably from the wide-ranging domestic economic package Democrats had initially...more
Congress ended a busy work period after passing the Inflation Reduction Act (IRA) last week. This Holland & Knight alert summarizes the healthcare provisions in the IRA and provides an outlook on health policy issues that may...more
Following 15 hours of debate and votes, the U.S. Senate passed legislation this weekend tackling inflation, climate change, and health care. The Senate approved the Inflation Reduction Act on a 51-50 party-line vote,...more
The U.S. Senate on Aug. 7, 2022, passed the Inflation Reduction Act of 2022 (IRA). This comprehensive legislation is the result of many months of negotiations among Democrats to advance some of President Joe Biden's highest...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
Over the years, we’ve written about the difficulties in challenging the entitlement to Medicaid in the federal courts. In light of a series of Supreme Court decisions dating back to 1990, the pathway for an aggrieved Medicaid...more
On November 19, 2021, the U.S. House of Representatives voted to approve the Build Back Better Act (H.R. 5376, the “BBB Act”), the budget reconciliation bill that includes much of President Biden’s economic and social policy...more
Early Friday morning, the U.S. House of Representatives approved President Biden’s sweeping social and climate spending proposal known as the Build Back Better Framework. Key provisions in the approximately $2 trillion bill...more
This week, the House Energy and Commerce Committee approved sweeping health care legislation as part of the Democratic Congress’ plan to enact a $3.5 trillion legislative package through budget reconciliation. The committee...more
Group health plan sponsors soon will face daunting new disclosure and transparency requirements under multiple laws including the Affordable Care Act (ACA), the No Surprises Act (the Act) and the Consolidated Appropriations...more
On Monday, Aug. 9, 2021, the Senate Budget Committee released its budget resolution for fiscal year 2022. The bill will serve as the foundation for the broad, sweeping spending bill that Democrats and President Biden hope to...more
The courts continue to play an important role in health policy. 2020 saw several notable lawsuits related to the Affordable Care Act (ACA). Several other Trump administration policies were challenged, including Medicare...more