On June 11, 2025, the Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-03 (the Advisory Opinion), in which OIG approved of a proposed arrangement under which a management support organization and a physician-owned professional corporation (the Requestors) would enter into an arrangement involving the leasing of clinical employees
Medicare and Medicaid
False Claims Act Enforcement of Pharmacy Pricing & Prescribing Practices: The Walgreens Cases
By Danielle Tangorre, Robinson+Cole's Health Law Group & Ivy Miller on
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 FCA violations.
Allegations Related to Medicaid Billing for Generic Medications
In the first, on March 27, 2025, the U.S.
CMS Issues Guidance and Requests Information to Promote Hospital Price Transparency Compliance and Enforcement Efforts
By Conor Duffy on
On May 22, 2025, the Centers for Medicare & Medicaid Services (CMS) took a series of actions to promote enhanced price transparency compliance by hospitals and identify challenges thereto, in order to inform future price transparency enforcement activities and policies. These actions were taken in furtherance of the President’s February 2025 Executive Order No. 14221…
U.S. Supreme Court Denies DSH Hospitals’ Attempts to Seek Higher Medicare Payments
On April 29, 2025, the U.S. Supreme Court issued an opinion upholding the formula the U.S. Department of Health and Human Services (HHS) utilized to calculate Medicare hospitals’ disproportionate share hospital (DSH) payment adjustments, denying a challenge brought by hospitals seeking higher DSH reimbursement. In Advocate Christ Medical Center v. Kennedy, No. 23-715 (S.
Middle District of Florida Judge Finds False Claims Act’s Qui Tam Provision Unconstitutional
By Danielle Tangorre, Michael Lisitano & Guest Contributor on
*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…
DOJ Announces $1.3 Million Settlement Involving a Laboratory Marketer, Physicians, and the Physicians’ Medical Practices
By Danielle Tangorre & Robinson+Cole's Health Law Group on
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…
Key Second Circuit Decision Defines AKS Willfulness Standard
By Conor Duffy & Leslie Levinson on
Posted in Academic Medical Centers, Ambulance, Ambulatory Surgical Centers (ASC), Department of Justice, False Claims Act, Fraud and Abuse, Government Enforcement, Home Health/ Home Care, Hospice, Hospitals and Health Systems, Medicare and Medicaid, Office of Inspector General, Physicians and Allied Health Professionals
On March 12, 2024, the U.S. Court of Appeals for the Second Circuit issued an important decision interpreting the “willfulness” standard necessary to find a violation of the federal Anti-Kickback Statute (AKS). The decision provides important guidance for health care and pharmaceutical organizations on what constitutes a knowing violation of the AKS and for counsel…
Status of 340B Payment Remediation and Manufacturer Litigation
By Robinson+Cole's Health Law Group on
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…
HHS Finalizes Updates to “Part 2” Regulations to Align Disclosure Rules with HIPAA and Promote More Coordinated Substance Use Disorder Care
By Conor Duffy & Robinson+Cole's Health Law Group on
Posted in Academic Medical Centers, Accountable Care Organizations, Department of Justice, Government Enforcement, Health Information Exchanges and Electronic Medical Records (EMRs), Health Policy, HIPAA, Hospitals and Health Systems, Legislation, Medicare and Medicaid, Physicians and Allied Health Professionals, Privacy and Security
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…
HHS Proposes Disincentives for Providers that Commit Information Blocking
By Nathaniel Arden & Michael Lisitano on
On November 1, 2023, the U.S. Department of Health and Human Services (HHS) published a proposed rule titled “21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking” (the Proposed Rule). The Proposed Rule, if finalized, would create disincentives for health care providers that the HHS Office of Inspector General (OIG) determines have committed “information blocking” (as defined at 45 C.F.R. § 171.103).
Continue Reading HHS Proposes Disincentives for Providers that Commit Information Blocking