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.
Medicare and Medicaid
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
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 & Yelena Greenberg 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
OIG Issues Favorable Opinion Regarding Physician Group’s Proposal to Pay Bonuses to its Employed Physicians Based on Net Profits
On October 13, 2023, the Office of Inspector General (OIG) published Advisory Opinion 23-07 (Advisory Opinion), in which the OIG issued a favorable opinion regarding a physician group employer’s proposal to pay bonuses to its employed physicians based on net profits derived from certain procedures performed by the physicians at ambulatory surgery centers.Continue Reading OIG Issues Favorable Opinion Regarding Physician Group’s Proposal to Pay Bonuses to its Employed Physicians Based on Net Profits
New York OMIG Issues 2022 Annual Report
By Danielle Tangorre & Guest Contributor on
On Monday, October 2, 2023, the New York Office of the Medicaid Inspector General (OMIG) published its Annual Report for 2022. The Report details the various efforts that New York’s Medicaid program undertook in 2022 to accrue $3.4 billion in recoveries and cost avoidance.Continue Reading New York OMIG Issues 2022 Annual Report
Two Pathways for Medicaid Self-Disclosures Announced by OMIG
By Danielle Tangorre on
The New York Office of the Medicaid Inspector General (OMIG) recently announced updates to its Self-Disclosure Program in response to feedback from Medicaid stakeholders after its revised posting in January 2023. OMIG revised its disclosure process to have two pathways for healthcare providers to report, explain, and return overpayments by creating an “Abbreviated Self-Disclosure Process” in addition to the existing full disclosure process.Continue Reading Two Pathways for Medicaid Self-Disclosures Announced by OMIG