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
State laws seeking to regulate pharmacy benefit managers (PBMs) have increased significantly over the past few years. As it stands, all 50 states have laws that regulate PBMs in some way, but all are unique. However, most of...more
A recent wave of cases has attempted to apply the theory of liability for retirement plan excessive fee cases to health plans – specifically, arrangements with pharmacy benefit managers. Though the cases thus far have...more
Our Employee Benefits & Executive Compensation Group discusses what health plan sponsors need to know about the final rule on nonquantitative treatment limitations (NQTLs) and NQTL comparative analysis under the Mental Health...more
Effective January 1, 2025, Kentucky has new law regulating pharmacy benefit managers (“PBMs”). Earlier this year, the Governor of Kentucky signed SB 188 into law, making Kentucky the latest state to pass legislation...more
Does your company's health plan provide prescription drug coverage? If so, you have until October 15, 2024 to send a notice to individuals who are enrolled in Medicare Part A or Part B and are eligible for the company's...more
The Inflation Reduction Act of 2022 made significant design changes to Medicare Part D effective January 1, 2025. The changes will cause an increase in the actuarial value of Medicare Part D coverage, which will impact...more
I read the Lewandowski v. Johnson & Johnson class action complaint and couldn’t help but wonder – are plans and participants doomed, or can employers take proactive steps to satisfy their fiduciary duties and potentially...more
Many plan sponsors have read about the lawsuit filed against Johnson & Johnson alleging that it breached its fiduciary duties with regard to the prescription drug component of its group health plan, causing participants to...more
The February Monthly Minute discusses a class action suit alleging a breach of fiduciary duties in connection with ERISA benefit plan prescription drug pricing and the latest IRS guidance on defined contribution plan...more
A novel proposed class action lawsuit was filed against Johnson & Johnson (J&J) earlier this month by a current employee for mismanagement of prescription drug prices. The lawsuit alleges, among other things, that J&J...more
As employers look back at 2023 and ahead to 2024, there are so many compliance-related items to consider relating to their employee benefit plans. The rules employers are supposed to be complying with keep growing and...more
Summary - Employers taking advantage of copay accumulator programs now face unexpected administrative complications following a recent federal court decision....more
The time may have come to add a welfare plan committee to your company’s governance of employee benefit plans. New legal obligations and other developments impose fiduciary risks for welfare plans similar to what already...more
On March 3, 2023, federal agencies released revised Prescription Drug Data Collection (RxDC) Reporting Instructions applicable to the 2022 reference year. RxDC reporting for the 2022 reference year is due on or before June 1,...more
In a move akin to last-minute gift-giving, the Departments of Labor, Health and Human Services, and the Treasury (the “Departments”) released FAQ 56 on December 23, 2022, which provides relief regarding the Prescription Drug...more
Employers have a reprieve from the challenging December 27, 2022, deadline for reporting 2020 and 2021 prescription drug cost information to the U.S. Department of Health and Human Services (HHS). ...more
On December 23, 2022, FAQs were released outlining late-breaking RxDC Reporting Relief. Of note - 1. For the 2020 and 2021 data submissions that are due by December 27, 2022, the Departments will not take enforcement...more
The 2021 Consolidated Appropriations Act (CAA) established new transparency requirements for group health plans to report specific information about prescription drugs and health care spending to the Centers of Medicaid and...more
Does your company's health plan provide prescription drug coverage? If so, you have until October 15, 2022 to send a notice to individuals who are enrolled in Medicare Part A or Part B and are eligible for the company's...more
Employers and their benefit administrators have more detail and a more convenient way to submit “top 50” lists and other data - but no more time to comply with - daunting prescription drug cost reporting requirements in the...more
On this episode of Williams Mullen's Benefits Companion, host Brydon DeWitt discusses the Biden administration’s interim final rule that requires health plans to report prescription drug and health coverage costs and its...more
Most employers who offer plans that include prescription drug coverage are acutely aware of the requirement to notify individuals as to the creditable status of that coverage before October 15 each year. However, many are...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
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
Welcome to Goodwin’s ERISA Litigation Update. Litigation involving ERISA-governed benefits plans has exploded in recent years. Lawyers in our award-winning ERISA Litigation practice have extensive experience litigating these...more