Proskauer's perspective on health care law and business
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…
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…
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…
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…
[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”)…
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…
SB 1120 (the “Bill”), which takes effect on January 1, 2025, amends existing California law to adopt guardrails around the use of artificial intelligence tools for the purpose of utilization management.[1] As discussed in a prior Proskauer alert, the Bill represents one of the latest attempts by the…
On December 11, 2024, the Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) issued a special fraud alert warning about certain marketing schemes that involve questionable payments and referrals between Medicare Advantage (“MA”) health plans, health care professionals, and third-party marketers (e.g., agents and…
This week, the U.S. Attorney’s Office for the District of Colorado (“USAO”) announced that it entered into a series of interrelated settlement agreements with companies that provide intraoperative neuromonitoring (“IONM”) services, the companies’ founder, a neurosurgeon, and a businessman affiliated with the companies. IONM services involve the use of electrodes…
The health care industry is anxiously awaiting the First Circuit’s ruling on the standard of causation for actions brought under the False Claims Act (FCA) predicated on a federal Anti-Kickback Statute (AKS) violation. The First Circuit will decide whether the FCA “result[s] from” a kickback if that claim would not…
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