Monitoring the Pulse of Health Care and Life Sciences
*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…
The Office for Civil Rights of the Department of Health and Human Services (OCR) was busy negotiating and settling enforcement actions in November and early December. Since October 31, 2024, the OCR has settled five separate cases of alleged HIPAA violations. The settlements include resolution agreements and civil monetary penalties.
One of the settlements and…
*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…
*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…
*This post was co-authored by Lily Denslow, legal intern at Robinson+Cole. Lily is not admitted to practice law.
On June 27, 2024, the Department of Justice (DOJ) announced its 2024 National Health Care Fraud Enforcement Action, which resulted in criminal charges against 193 defendants for alleged participation in various health care fraud schemes alleged to…
This post is co-authored by Seth Orkand, co-chair of Robinson+Cole’s Government Enforcement and White-Collar Defense Team.
On April 29, 2024, the Department of Justice (DOJ) announced a $1.3 million settlement (Settlement) with a South Carolina clinical laboratory marketer and his marketing company, and three physicians and their medical practices in North Carolina…
