On February 5, 2026, the Massachusetts Health Policy Commission (HPC) published proposed amendments to its Material Change regulations at 958 CMR 7.00 (the Proposed Amendments). Among other things, the Proposed Amendments broaden the HPC’s market review authority by subjecting more transactions to the HPC’s Material Change Notice (MCN) process and provide the HPC greater latitude
HRSA Requests Comments on Second Iteration of 340B Rebates
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
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
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
CMS Adds New Requirements to Hospital Price Transparency Reporting
On November 21, 2025, the Centers for Medicare & Medicaid Services (CMS) published the CY 2026 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center Final Rule (the Rule), which includes several significant changes to hospital price transparency regulations. The changes follow from Executive Order 14221, entitled “Making America Healthy Again by Empowering Patients
Appeals Dropped of Decision Vacating HIPAA Reproductive Health Privacy Rule, Confirming Apparent End of the Rule and Attestation Requirement
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
OIG Shines Spotlight on Billing for Remote Patient Monitoring
This post is co-authored by Seth Orkand, co-chair of Robinson+Cole’s Government Enforcement + White-Collar Defense Team.
On August 25, 2025, the Department of Health and Human Services Office of Inspector General (OIG) issued a new report (Report) highlighting trends in remote patient monitoring (RPM) Medicare billing, recommending stronger oversight to ensure compliance in billing
Appellate Court Gives Go-Ahead for 340B Contract Pharmacy Insulin Pricing Suit to Proceed
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
New York Streamlines CON Requirements for Medical Facility Construction Projects
On August 6, 2025, the New York Department of Health finalized and made effective significant changes to the Certificate of Need (CON) review process for health facility construction projects. The changes amend § 710.1 of Title 10 of the New York Codes, Rules, and Regulations (NYCRR), streamlining regulatory review and raising cost thresholds to reflect
HRSA Publishes 340B Rebate Pilot Program FAQs
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