The Department of Justice’s (“DOJ”) May 19, 2025 “Civil Rights Fraud Initiative” memorandum, issued by Deputy Attorney General Todd Blanche (the “Initiative”), marks a consequential policy shift for False Claims Act (“FCA”) enforcement. The Initiative instructs every U.S. Attorney’s Office to “aggressively pursue” compliance with federal civil rights laws, as those laws have been interpreted by the Supreme Court under the 2023 Harvard admissions decision. The effect of this order is to treat a recipient’s knowing violation of federal civil rights laws as a “false claim” whenever that recipient has certified, impliedly or expressly, that it would comply with those laws as a condition of receiving federal dollars.
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…
Disproportionate Impact: Supreme Court Narrows Disproportionate Share Hospital Reimbursement to Supplemental Security Income Cash Recipients
The U.S. Supreme Court has issued a significant ruling affecting hospitals that serve low-income Medicare beneficiaries, narrowing the interpretation of the Disproportionate Share Hospital (“DSH”) payment formula. In Advocate Christ Medical Center v. Kennedy, the Court determined that only Medicare patients who were eligible to receive a cash Supplemental…
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…
HHS Scraps Richardson Waiver, Clearing Way for Faster Rulemaking
On March 3, 2025, the United States Department of Health and Human Services (“HHS”) issued a policy statement rescinding the Richardson Waiver, a policy in place since 1971 that required notice-and-comment rulemaking for regulations on public property, loans, grants, benefits, or contracts. Under the new framework, HHS and its…
First Circuit Clarifies FCA Liability Standard for AKS Violations, Deepening Circuit Split
The First Circuit has issued its long-anticipated opinion in United States v. Regeneron Pharmaceuticals, Inc., clarifying the standard for establishing False Claims Act (“FCA”) liability based on Anti-Kickback Statute (“AKS”) violations. The First Circuit held that an AKS violation must be the “but-for” cause of a claim for it…
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”)…
Spurred on by the Steward Health Care Bankruptcy, Massachusetts Adopts Bill Regulating Private Equity and REITs in Health Care, Continuing a National Trend
By David Manko, Jason S. Madden & Jonian Rafti on
On January 8, 2025, Massachusetts Governor Maura Healey signed into law House Bill 5159 (the “Bill”). The Bill grants the state new regulatory powers to oversee and review health care transactions involving private equity firms, real estate investment trusts (“REITs”), and management services organizations (“MSOs…