On January 21, 2026, the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) submitted its Fall 2025 Semiannual Report to Congress, identifying investigative outcomes relating to HHS program administration and operations during the six‑month period from April 1, 2025 through September 30, 2025. Similar to
Regulatory Compliance
Sign‑On Bonuses to Employees: OIG Warns of Heightened Risk
The Office of Inspector General (“OIG”) recently issued advisory opinion 25‑12 (“the Opinion”), which addresses a home care agency’s plan to advertise and pay sign‑on bonuses to prospective attendant‑employees, many of whom are family members of Medicaid beneficiaries who would also select the agency for their relative’s Medicaid‑covered services. OIG…
DOJ Begins Issuing Demand Letters to Contractors Under New Civil Rights Fraud Initiative
[This blog post was originally published on Proskauer’s Government Contractor Compliance & Regulatory Update blog here.]
The U.S. Department of Justice (the “DOJ”), Civil Division, has started issuing Civil Investigative Demands (“CIDs”) to federal contractors and grant recipients, seeking detailed information about their diversity, equity, and inclusion (“DEI”) practices. This move is part…
DOJ Targets Gender‑Affirming Care under FDCA and FCA: Scrutinizes Off‑Label Drug Use and False Diagnosis Codes
Last month, the United States Department of Justice (“DOJ”) issued its “Civil Division Enforcement Priorities” memorandum, memorializing a shift from its predecessor administration’s policy on gender‑affirming healthcare (“DOJ Memo”). The DOJ Memo portends a significant rise in government investigations and False Claim Act (“FCA”) liability for suppliers and providers…
CMS to Immediately Begin Auditing Medicare Advantage Plans in Significant Expansion of Enforcement Efforts
On May 21, 2025, the Centers for Medicare and Medicaid Services (“CMS”) announced a significant expansion of its auditing efforts with respect to Medicare Advantage (“MA”) plans.
For newly initiated audits of MA plans, CMS will audit all eligible MA contracts for each payment year. Additionally, for audits already initiated…
NY DOH Publishes Electronic Material Health Care Transaction Reporting Form, Increasing Disclosure Requirements to Include Potentially Sensitive Business Information
By David Manko, Jason S. Madden & Jonian Rafti on
On May 15, 2025, the New York State Department of Health (“DOH”) announced the launch of the electronic Material Transaction Reporting Form for health care transactions (“Electronic Form”). To assist reporting entities in preparing their submissions, the DOH has also released a list of all questions included in the Electronic…
Post‑Chevron Spotlight: Federal Court Nixes FDA Rule Reclassifying Laboratory Services as Medical Devices
In another rebuke to federal regulatory overreach, the U.S. District Court for the Eastern District of Texas (“District Court”) has vacated the Food and Drug Administration’s (“FDA”) 2024 final rule that sought to bring laboratory‑developed test services (“LDTs”) within the scope of the agency’s medical device regulatory framework. The case…
DOH Issues Guidance on New York’s Material Health Care Transaction Law
Nearly two years ago, and as previously discussed in a Proskauer alert, New York enacted Public Health Law Article 45-A (the “Material Transactions Law”), which requires reporting of certain material health care transactions. Last month, the New York State (“NYS”) Department of Health (“DOH”) published long-awaited guidance concerning the…
DEI and Government Contractors: A High-Stakes Shift
By Guy Brenner & Olympia Karageorgiou on
[This post has been re-published from Proskauer’s “Government Contractor Compliance & Regulatory Update” blog: DEI and Government Contractors: A High-Stakes Shift | Government Contractor Compliance & Regulatory Update.]
While much of the focus on President Trump’s recent Executive Order on Ending Illegal Discrimination and Restoring Merit-Based Opportunity (the “EO”)…
CMS Publishes Final Rule, Effective January 1, 2025, Addressing the Requirements for Reporting and Returning Overpayments
By Matthew J. Westbrook, Vinay Kohli & David Manko on
The standard for an “identified overpayment” under Medicare Parts A–D now aligns with section 1128J(d)(4)(A) of the Social Security Act, which incorporates by reference the Federal False Claim Act’s (the “FCA”) “knowledge” standard. The previous “reasonable diligence” standard, which, as it related to Part C, had been…