This post was co-authored with Ivy Miller, legal intern at Robinson+Cole. Ivy is admitted to practice in Massachusetts.
On December 29, 2025—just three days before the 340B Rebate Model Pilot Program (the Rebate Program) was set to begin—the U.S. District Court for the District of Maine issued an order granting a preliminary injunction to block
This post was co-authored with Antitrust + Trade Regulation lawyer Jennifer Driscoll and Ivy Miller, legal intern at Robinson+Cole. Ivy is admitted to practice in Massachusetts.
On August 6, 2025, the U.S. Court of Appeals for the Second Circuit issued an opinion allowing a case challenging drug pricing changes to proceed. The case, an antitrust
This post was co-authored with Ivy Miller, legal intern at Robinson+Cole. Ivy is admitted to practice in Massachusetts.
As previously discussed in our prior blog post, on August 1, 2025, the Department of Health and Human Services (HHS) issued a Notice announcing a much-anticipated 340B Rebate Model Pilot Program (Pilot Program). Subsequently, the Health
This post was co-authored by Paul Palma, legal intern at Robinson+Cole. Paul is not admitted to practice law.
On July 31, 2025, the Department of Health and Human Services (HHS) announced a much-anticipated 340B Rebate Model Pilot Program (Pilot Program) via guidance (Guidance) that will be formally published on August 1, 2025. The Pilot Program
This post was co-authored with Ivy Miller, legal intern at Robinson+Cole. Ivy is admitted to practice law in Massachusetts.
The Department of Justice has launched a number of enforcement actions targeting pharmacies for alleged violations of the False Claims Act (FCA). Recently, Walgreens has been the subject of two noteworthy government settlements related to alleged
This post is co-authored by Seth Orkand, co-chair of Robinson+Cole’s Government Enforcement and White-Collar Defense Team.
Massachusetts has expanded regulatory oversight of health care transactions by imposing False Claims Act liability on health care owners and investors for changes including failure to disclose violations. On January 8, 2025, Governor Maura Healey signed
State Law Permitting Dispensation of Emergency Contraception by Vending Machines
Legislation passed in 2022 in Massachusetts and in 2023 in Connecticut removes barriers for college students trying to obtain emergency contraception pills like Plan B One-Step. In light of uncertainty around abortion protections following the Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health
Below is an excerpt of an article published in American Health Law Association’s Regulation, Accreditation, and Payment Practice Group on March 21, 2024.
The 340B program, as established under Section 340B to the Public Health Service Act (PHSA), Pub. L. No. 78-410, 58 Stat. 682 (1944) (“340B Statute”),[1] has experienced significant legal challenges
On February 8, 2024, the U.S. Department of Health and Human Services (HHS) issued a final rule (Final Rule) updating federal “Part 2” regulations to more closely align the requirements applicable to substance use disorder (SUD) treatment records with the HIPAA privacy rule, and to make certain other changes. The regulations at 42
On September 27, 2023, the Health Resources and Services Administration (HRSA) issued a Notice in the Federal Register applicable to all 340B Program hospitals that formally ends a COVID-era waiver of the long-standing HRSA requirement that off-site, outpatient facilities be (1) listed as reimbursable on the hospital’s Medicare Cost Report (MCR) prior to participating in the 340B Program; and (2) registered and listed in the Office of Pharmacy Affairs Information System (OPAIS) prior to participating in the 340B Program.Continue Reading HRSA Confirms End of COVID Waiver of Advance Registration Requirement for Provider-Based Clinics