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
Welcome to the sixth issue of Health Headlines, a newsletter created by lawyers in our Healthcare practice....more
With the One Big Beautiful Bill Act (OBBB) passed by U.S. Congress and signed into law, Congress now has less than three weeks that it will be in session before government funding expires on Sept. 30, 2025. Appropriators will...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
This is part five in a series of executive orders related to health care. Trump Recission of Biden Administration Executive Orders - Medicaid and the Affordable Care Act (ACA)...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
Senate Committees Continue Nomination Hearings. The Senate VA Committee held a hearing for VA secretary nominee Doug Collins and subsequently voted for his confirmation with broad bipartisan support. His confirmation vote...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
The U.S. Court of Appeals for the Fifth Circuit has ruled in favor of Christian-owned businesses and individuals who sued over the Affordable Care Act (ACA) preventive care mandates. The appellate Court agreed with the...more
Disputes between 340B Drug Pricing Program-covered entities and the drug manufacturers required to sell outpatient drugs to those entities at discounted prices will be governed by an alternative dispute resolution (ADR)...more
The Cozen Lens- • Regardless of which candidate is victorious in November’s presidential election, populism will be sure to shape the next administration’s policies. • In an age of populism, Big Tech has increasingly...more
The United States Department of Health and Human Services (HHS) has filed court pleadings stating that it does not intend to initiate enforcement actions against plans that maintain copay accumulator programs....more
As we wrote about in our prior blog post, on September 29, 2023, John D. Bates of the U.S. District Court for the District of Columbia struck down a federal rule that permitted health plans and pharmacy benefit managers...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
Summary - Employers taking advantage of copay accumulator programs now face unexpected administrative complications following a recent federal court decision....more
Although President Biden’s budget is almost always dead on arrival on Capitol Hill, it serves as an outline of the administration’s priorities. In the budget process, the House and Senate are to work separately on budget...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
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
The federal government will delay for six months its enforcement of key portions of the Transparency in Coverage (TiC) final rule that goes into effect on January 1, 2022. The change was announced in guidance issued jointly...more
The U.S. Department of Labor, U.S. Department of Health and Human Services, and U.S. Department of the Treasury recently issued regulatory guidance on the requirement that health plans cover pre-exposure prophylaxis (PrEP)...more
Health plans and issuers racing to implement overlapping price transparency and disclosure requirements in response to the Transparency in Coverage final rule (TiC Final Rule) and the Consolidated Appropriations Act, 2021...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
On June 30, 2021, the Centers for Medicare & Medicaid (CMS) released Open Payments data for the past year, 2020. This new data publication comes amid heightened government scrutiny of payments by drug and medical device...more
Hughes v. Northwestern University, No. 19-1401: Whether allegations that a defined-contribution retirement plan paid or charged its participants fees that substantially exceeded fees for alternative available investment...more