On February 17, 2026, the Health Resources and Services Administration (HRSA) issued a Request for Information (RFI) regarding the use of rebates within the 340B Program. After an unsuccessful first attempt at deploying a rebate model late last year (as we previously wrote about here and here), HRSA is now seeking “input from interested
Pharmacy Law
Government Withdraws Appeal in 340B Rebate Pilot Program Litigation, Signaling Shift
The recent litigation concerning the government’s 340B Rebate Model Pilot Program (the Rebate Program), as further described below, took an unexpected turn as the federal government recently signaled that it intended to revise its approach to the Rebate Program. This change in strategy was previewed by the government in a letter filed with the Court…
DEA Extends Tele-Prescribing Flexibilities Yet Again – Now Through December 31, 2026 – to Avoid Telemedicine Cliff
On December 31, 2025, the federal Drug Enforcement Administration (DEA) extended current regulatory flexibilities related to tele-prescribing of controlled substances for another year. The DEA issued a fourth temporary extension (2026 Extension) of its pandemic-era telehealth flexibilities, which are now scheduled to end on December 31, 2026. The DEA explained that another extension…
Court Issues Nationwide Preliminary Injunction of the 340B Rebate Model Pilot Program
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 the government’s implementation of the Rebate Program on January 1, 2026, after determining that the Health Resources and…
Appeals Dropped of Decision Vacating HIPAA Reproductive Health Privacy Rule, Confirming Apparent End of the Rule and Attestation Requirement
By Conor Duffy & Ivy Miller on
On September 10, 2025, the U.S. Court of Appeals for the Fifth Circuit dismissed an appeal of the federal court ruling vacating key provisions of the HIPAA reproductive health care regulations, which appears to signal the end of the Purl case (previously discussed here) and to confirm the end of provisions of the HIPAA…
Appellate Court Gives Go-Ahead for 340B Contract Pharmacy Insulin Pricing Suit to Proceed
By Yelena Greenberg, Guest Contributor & Ivy Miller on
This post was co-authored with Antitrust + Trade Regulation lawyer Jennifer Driscoll.
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 action brought by health centers against certain insulin manufacturers, arises from alleged anticompetitive…
HRSA Publishes 340B Rebate Pilot Program FAQs
By Yelena Greenberg & Ivy Miller on
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 Resources and Services Administration (HRSA), which administers the 340B program, issued a set of FAQs providing additional guidance…
HHS Publishes 340B Guidance Proposing Rebate Pilot Program
By Yelena Greenberg & Guest Contributor on
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…
CMS Finalizes Standard for Identifying Overpayments and Grace Period for Investigations of Related Overpayments
By Conor Duffy & Leslie Levinson on
Posted in Academic Medical Centers, Ambulatory Surgical Centers (ASC), Department of Justice, False Claims Act, Fraud and Abuse, Government Enforcement, Health Policy, Home Health/ Home Care, Hospice, Hospitals and Health Systems, Laboratories, Long Term Care and Nursing Homes, Pharmaceuticals and Biologics, Pharmacy Law, Physicians and Allied Health Professionals, Private Equity, Reimbursement, Stark Law, Telehealth, Telemedicine
As part of its 2025 Physician Fee Schedule Final Rule (PFS Rule), the Centers for Medicare & Medicaid Services (CMS) finalized two crucial updates to federal Medicare overpayments regulations (sometimes referred to as the “60-Day Rule”) that (1) align the standard for when an overpayment is identified with the applicable standard under the…
DEA Extends Telehealth Lifeline for Patients
By Conor Duffy & Guest Contributor on
*This post was co-authored by Paul Palma, legal intern at Robinson+Cole. Paul is not admitted to practice law.
On November 15, 2024, the Drug Enforcement Administration (DEA) and the Department of Health & Human Services (HHS) jointly announced an extension of current COVID-era tele-prescribing flexibilities for another year – through December 31, 2025 – via…