Tag archives: Stark Law

Healthcare Regulatory Landscape Transformed by Stark, AKS Final Rules

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 November 20, 2020 long-awaited final rules changing the regulations addressing the Anti-Kickback Statute (“AKS”) and … Continue reading

COVID-19 Update: CMS Issues Wide Ranging Blanket Waivers to Assist Providers

By Thomas Dowdell (US), Mark Faccenda (US), Jeff Wurzburg (US), Joseph Keillor (US) and Hayley White (US) on March 31, 2020 Posted in Coronavirus, General, Regulatory

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 will remain in effect until the end of the emergency declaration. CMS issued a summary … Continue reading

HHS Memorandum Addresses Implications of Allina Decision

By Chandra Westergaard (US) and Jeff Wurzburg (US) on November 26, 2019 Posted in News from DC

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 General Counsel’s (OGC) “views on the impact of Azar v. Allina Health Services, 139 S. … Continue reading

CMS and OIG release sweeping proposals to modernize Stark Law and AKS regulations

By Joseph Keillor (US) on October 16, 2019 Posted in General, News from DC, Regulatory

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 Stark Law and Anti-Kickback Statute (AKS) regulations. We have summarized a portion of those proposed … Continue reading

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

By Thomas Dowdell (US), Debbi Johnstone (US), Stacey Murphy (US) and Benjamin Wallfisch (US) on October 14, 2019 Posted in General, News from DC, Regulatory

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) regulations to adapt to and promote the US health care system’s transformation to value-based payment … Continue reading

CMS further crystalizes Stark liberalizations

By Joseph Keillor (US) and Debbi Johnstone (US) on August 21, 2018 Posted in Regulatory

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 Act of 2018 (“2018 BBA”). As we previously reported, Section 50404 of the 2018 BBA … Continue reading

CMS solicits comments for easing Stark Law burdens

By Benjamin Wallfisch (US) on June 25, 2018 Posted in Regulatory

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 Stark Law may have a negative effect on alternative payment models, integrated delivery models, and … Continue reading

Budget Act codifies Stark liberalizations

By Thomas Dowdell (US) and Joseph Keillor (US) on February 20, 2018 Posted in News from DC, Regulatory

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 amendments to the Stark Law. Specifically, Section 50404 endorses recent liberalizations of the Stark Law requirements … Continue reading

Deregulatory wave prompts renewed examination of Stark Law application

By Debbi Johnstone (US), Joseph Keillor (US) and Sarah Jean Kilker (US) on February 2, 2018 Posted in Regulatory

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 to examine possible ways to minimize the regulatory barriers of fraud-and-abuse laws, including the Stark … Continue reading

Judge doubles down on finding of materiality in FCA case

By Joseph Keillor (US) and Sarah Jean Kilker (US) on September 26, 2017 Posted in Enforcement

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 of what contractual requirements will not likely be viewed as material, at least one federal … Continue reading

CMS issues new Self-Referral Disclosure Protocol (SRDP)

By Savannah Wiseman (US) and Joseph Keillor (US) on April 17, 2017 Posted in Regulatory

CMS recently finalized a new Self-Referral Disclosure Protocol (SRDP) that includes forms for healthcare providers to use to disclose actual and potential violations of the federal physician self-referral statute (the “Stark Law”). Use of the new forms is mandatory starting June 1, 2017, but CMS encourages healthcare providers to start using the new forms immediately. … Continue reading