EpiPen RICO Ruling Opens Door for Private AKS Enforcement
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
Drug Pricing Initiatives During the Trump Presidency
As prescription drug costs remains a significant, and largely bipartisan, issue for state and federal legislators, we continue to see activity focused on pharmacy benefit managers (PBMs) as we approach the last quarter of...more
House Education & the Workforce Health, Employment, Labor, and Pensions Subcommittee Holds Hearing on ERISA’s 50th Anniversary. Members and witnesses assessed how the Employee Retirement Income Security Act of 1974 (ERISA)...more
On June 17, 2024, the final rule for Medicare Part D introduced new health IT standards, mandating the adoption of NCPDP SCRIPT Standard version 2023011 by January 1, 2028, while the NCPDP Formulary and Benefit (F&B) Standard...more
To date, 2024 has not yet seen the type of mega-merger (Pfizer/Seagen) or level of agency enforcement (Sanofi/Maze or Amgen/Horizon) as 2023. But two notable investigations — one still active — show the Federal Trade...more
Congress is back from a long August recess. However, it is only back for a few weeks. During this window, there is only one major thing Congress must do: extend government funding past the September 30 deadline through a...more
DOJ recently formed the Antitrust Division’s (the “Division”) Task Force on Health Care Monopolies and Collusion (“HCMC”), signaling anticompetitive activity in health care markets as an enforcement priority....more
A new litigation trend is emerging regarding fiduciaries of health plans and their duties to prudently evaluate fees being charged by pharmacy benefit managers (“PBM”). Two Fortune 50 employers, Johnson & Johnson and Wells...more
Welcome to our fourth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we address a variety of topics including a recent SCOTUS ruling and the potential impact on CMS, issues of patient...more
On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug...more
At an Open Commission Meeting on August 1, 2024, the Federal Trade Commission (FTC) presented a report prepared by its staff entitled Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main...more
Investment and administrative committees for employer-sponsored retirement plans have long been the gold standard for a company to carry out its fiduciary obligations to plan participants as required by the Employee...more
This week marks the second anniversary of the enactment of the Inflation Reduction Act, a partisan law that ushered in sweeping Medicare price setting reforms. The Biden-Harris Administration is poised to announce the first...more
Last week, former Wells Fargo employees filed a class action lawsuit against Wells Fargo and its health plan fiduciaries alleging that Wells Fargo’s self-funded health plan violated ERISA by paying its pharmacy benefits...more
In this blog and the webinar linked below, we offer a comprehensive analysis of three critical areas transforming the sector: GLP-1 medications, biosimilars, and PBM transparency. Our analysis covers diabetes and weight loss...more
It has been a busy year for issues related to drug pricing, and with the election around the corner, litigation issues that have been developing over the last few years are likely to be a key focus for the second half of...more
A bipartisan group of attorneys general from 31 states and the District of Columbia filed an amicus brief in support of a petition for certiorari by Oklahoma’s insurance commissioner to review a decision by the U.S....more
This overview is excerpted from Manatt on Health, Manatt’s subscription service that provides in-depth insights and analysis focused on the legal, policy and market developments....more
Federal Circuit Allows Teva Patents to Remain in Orange Book. - The Federal Circuit recently granted Teva Pharmaceutical’s motion for a stay of removal of its patents from the Orange Book in its ongoing dispute with...more
Mintz’s PBM practice is pleased to present a 2024 year-to-date PBM Policy and Legislative Update. This edition builds upon prior issues and summarizes activity from January through June that impacts the PBM industry. It...more
The July Monthly Minute considers the impact of the Supreme Court’s Loper decision in overturning the longstanding Chevron deference standard, along with a district court case awarding penalties for failing to produce plan...more
House Oversight and Accountability Committee Holds Hearing on PBMs. Republicans and Democrats shared concerns about the role and practices of PBMs. While generally supportive of free market principles, Republicans criticized...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
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 Cozen Lens - While it’s becoming ever clearer Vice President Harris is likely to be the Democratic nominee following President Biden’s decision to step aside, it’s less clear what the impact will be on the presidential...more
Exactly two weeks after issuing an interim staff report on Pharmaceutical Benefit Managers (PBMs) pursuant to its Section 6(b) authority to study markets, the Federal Trade Commission (FTC) has initiated another 6(b) study...more