Health Law Diagnosis

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 into law H.5159

This post is co-authored by Seth Orkand, co-chair of Robinson+Cole’s Government Enforcement and White-Collar Defense Team.

Under a new 2025 law, Massachusetts is one of the first in the nation to broaden its state False Claims Act (FCA) to require disclosures by investors and owners of health care entities. On January 8, 2025, Governor Maura

*This post was authored by Nicole Benevento, law intern at Robinson+Cole. Nicole is not admitted to practice law.

The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed Tests (LDTs). The Final Rule requires laboratories to adhere to the same preapproval and post-marketing requirements of mass-produced

*This post was co-authored by Paul Palma, legal intern at Robinson+Cole. Paul is not admitted to practice law.

In November 2024, the Department of Health and Human Services Office of Inspector General (OIG) published the results of its audit assessing hospital compliance with the federal Hospital Price Transparency Rule (HPT Rule). OIG determined that 37

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

In a highly anticipated decision on an issue facing courts across the country, the Massachusetts Supreme Judicial Court held in late October that Massachusetts hospitals’ use of online tracking technologies that collect and transmit browsing activities of website visitors does not violate the Massachusetts Wiretap Law. 

The Court determined that online interactions between visitors and

*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

*This post was co-authored by Paul Palma, legal intern at Robinson+Cole. Paul is not admitted to practice law.

On September 30, 2024, Judge Kathryn Kimball Mizelle of the U.S. District Court for the Middle District of Florida issued an order in United States ex rel. Clarissa Zafirov v. Florida Medical Associates, LLC, holding that the

On September 28, 2024, California Governor Gavin Newsom vetoed California Assembly Bill 3129 (the Bill). The Bill, if enacted, would have imposed new notice and consent requirements for private equity investors involved in healthcare transactions. Governor Newsom’s veto statement clarifies the Bill’s vetoing, stating that the Office of Health Care Affordability (OHCA) “was created as

*This post was co-authored by Paul Palma, legal intern at Robinson+Cole. Paul is not admitted to practice law.

On September 18, 2024, the Department of Justice (DOJ) announced a settlement with Dunes Surgical Hospital and United Surgical Partners International, Inc. (USPI), an entity holding a partial ownership interest in Dunes, in connection with alleged violations of