Another Setback for 340B Pharmacies

In the latest challenge to hospitals’ rights to use contract pharmacies, drug manufacturers targeted a Maryland law that barred them from restricting shipments of 340B drugs to contract pharmacies. In a disappointing turn for hospitals, the Fourth Circuit sided with the manufacturers and overturned a lower court ruling that had favored the state, clearing the way for the manufacturer’s unilateral restrictions to potentially move forward. This ruling contrasts earlier decisions issued by other courts, which had generally favored states who had issued laws similar to that enacted by Maryland.

AstraZeneca Joins Industry Shift to 340B Claims Data Reporting

In yet another escalation of data transparency requirements, AstraZeneca has joined the ranks of Eli Lilly and Novo Nordisk and announced that effective May 1, 2026, covered entities must submit pharmacy and medical claims data for all 340B purchases, including in-house pharmacy dispensations, as a condition of accessing 340B pricing.

OIG Allows Subsidies for Clinical Trials

The U.S. Department of Health and Human Services, Office of Inspector General recently issued a favorable advisory opinion (26-05) in which it approved a medical device company’s proposal to subsidize certain Federal health care program cost-sharing obligations for a clinical trial that evaluated Company’s U.S. Food & Drug Administration-approved device in a new patient population with heart failure. Company proposed to pay in full the cost-sharing obligations that eligible participating patients would owe to Medicare for reimbursable items and services furnished during the trial.

A Tool Used Against NY Providers

No-fault insurers have increasingly relied on Examinations Under Oath as a tool to investigate claims submitted by medical providers. EUOs were originally intended as a tool for insurers to verify information related to a specific claim and to ensure that treatment billed was related to the underlying accident.

OIG Approves Discounts to ASCs

The U.S. Department of Health and Human Services, Office of Inspector General recently issued a favorable advisory opinion (26-03) in which it approved a Manufacturer’s proposal to give discounts on its conventional intraocular lenses and other surgical supplies used in cataract surgeries to ambulatory surgery centers if the ophthalmological practices that used the ASCs paid a one-time set up fee and a monthly subscription fee at full price for Manufacturer’s web-based software platform.