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
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
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
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
On July 9, 2024, the Federal Trade Commission (“FTC”) released an interim report describing their ongoing study of pharmacy benefit managers (“PBMs”) and their impact on access to and affordability of medicines....more
The West Virginia Office of the Insurance Commissioner (“WV OIC”) recently took regulatory actions against four unaffiliated Pharmacy Benefit Managers (“PBMs”) that were operating in West Virginia without a PBM license. These...more
Under the Consolidated Appropriations Act of 2021 (“CAA”), employer-sponsored group health plans, including medical-only plans, must submit information about their prescription drugs and health care spending. This submission...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
News Briefs - U.S. to Accelerate Medicare Payments in Wake of Cyberattack - The U.S. government said it will accelerate Medicare and Medicaid payments to some hospitals hurt by a hack at insurer UnitedHealth's technology unit...more
On February 21, 2024, Change Healthcare, a platform that provides certain technology solutions for the health care industry, experienced a nationwide network interruption related to a cybersecurity issue (cyber incident) and...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
An employer health plan is the latest target of class action litigation seeking redress for the alleged conduct of the plan's pharmacy benefit manager ("PBM")....more
The first complaint was filed in what is expected to be a wave of litigation alleging breach of fiduciary duty in selecting and monitoring welfare plan vendors. While the facts of this particular case may make it somewhat...more
The Louisiana Insurance Department (“Department”) recently fined Express Scripts Administrators, LLC (“ESA”) $275,000 and MedImpact Healthcare Systems, Inc. (“MedImpact”) $250,000 for allegedly failing to pay electronically...more
On September 18, 2023, the Florida Office of Insurance Regulation (“OIR”) published proposed rules to implement provisions of the Prescription Drug Reform Act (Florida Senate Bill 1550) governing Pharmacy Benefit Managers...more
This WSJ story highlights the challenges faced by patients as they navigate the “convoluted” ways in which drug prices are set between manufacturers and the pharmacy benefit managers (PBMs) who negotiate on behalf of health...more
In the final days of October, the New York Department of Financial Services (“DFS) published new regulations regarding assessing, licensing, and recordkeeping for pharmacy benefit managers (“PBM”) while revising existing...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
On August 15, 2023, the U.S. Court of Appeals for the Tenth Circuit (the “Tenth Circuit”) issued its decision in Pharmaceutical Care Management Association (PCMA) v. Mulready, one of the first major opinions to further define...more
On August 15, 2023, the U.S. Court of Appeals for the Tenth Circuit issued an opinion in Pharmaceutical Care Management Association v. Glen Mulready, in his official capacity as Insurance Commissioner of Oklahoma, Oklahoma...more
In a win for self-funded (i.e., self-insured) health plans subject to the Employee Retirement Income Security Act of 1974, as amended (ERISA), the Tenth Circuit recently ruled that ERISA preempts provisions of an Oklahoma law...more
ERISA’s notorious preemption clause is no more than a few lines of text. But it has a dramatic effect on the trillions of dollars flowing through ERISA pension and health plans in any given year. The U.S. Supreme Court has...more
January 1, 2024 is rapidly approaching, which is when California’s new Office of Health Care Affordability (OHCA) is set to begin advance regulatory review of certain health care mergers, acquisitions, affiliations, and other...more
Florida OIR Issues Informational Memorandum OIR-23-04M to PBMs - On July 19, 2023, the Florida Office of Insurance Regulation (“OIR”) issued Informational Memorandum OIR-23-04M (“Memorandum”) to Pharmacy Benefit Managers...more
Insurance regulators and examiners (“Insurance Regulators”) are increasing their efforts to scrutinize pharmacy benefit managers (“PBMs”), including conducting examinations of their business operations and initiating...more
In November of 2022, we predicted a fertile post-election congressional landscape for Pharmacy Benefit Manager (PBM) practice reform. Six months into the 118th Congress, we can confirm that PBM reform has, as expected, risen...more