In what may prove to be the most substantial fraud and abuse rulemaking in over a decade, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) and Centers for Medicare & Medicaid Services (“CMS”) published on
Stark Law
COVID-19 Update: CMS Issues Wide Ranging Blanket Waivers to Assist Providers
On Monday, March 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued wide ranging blanket waivers and published an interim final rule intended to “equip the American healthcare system with maximum flexibility” to respond to COVID-19. The waivers…
HHS Memorandum Addresses Implications of Allina Decision
On November 21, an internal HHS memorandum addressed to Centers for Medicare & Medicaid Services (CMS) Principal Deputy Administrator Demetrios Kouzoukas entitled “Impact of Allina on Medicare Payment Rules” became publicly available. The memorandum addresses the HHS Office of the…
CMS and OIG release sweeping proposals to modernize Stark Law and AKS regulations
On Thursday, October 17, 2019, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) will publish in the Federal Register two proposals to implement major changes to…
US regulators to align key health care regulations with transformation to value-based care system; CMS and OIG propose major overhaul of Stark Law and AKS regulations
On October 9, 2019, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued two sweeping proposals aimed at revising the Stark Law and Anti-Kickback Statute (AKS)…
CMS further crystalizes Stark liberalizations
On July 12, 2018, CMS included within the CY 2019 Physician Fee Schedule (the “Proposed Rule”) two revisions to Stark Law regulations aimed at further clarifying any actual or perceived differences between current regulations and the recently enacted Bipartisan Budget…
CMS solicits comments for easing Stark Law burdens
Last week, the U.S. Centers for Medicare & Medicaid Services (“CMS”) released a Request for Information (“RFI”) that seeks feedback from stakeholders in the healthcare industry on possible regulatory changes to the Stark Law. CMS has expressed concern that the…
Budget Act codifies Stark liberalizations
As we previously reported, on February 9, the U.S. Senate and House of Representatives approved the Bipartisan Budget Act of 2018 (the “Act”) and President Trump subsequently signed the bill into law. Section 50404 of the Act includes several…
Deregulatory wave prompts renewed examination of Stark Law application
In another sign that the Trump administration’s penchant for regulatory flexibility may apply to the federal fraud-and-abuse regulatory regimes, CMS administrator Seema Verma announced during an AHA Town Hall webcast on January 17 that CMS is convening an interagency group…
Judge doubles down on finding of materiality in FCA case
Federal courts continue to grapple with applying the “materiality” standard that is needed to cause a Stark Law violation or other underlying compliance matter to trigger False Claims Act liability. Although we have recently begun to gain a clearer view…