Debbi Johnstone (US)

Subscribe to all posts by Debbi Johnstone (US)

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) 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

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

Federal district court endorses Stark liberalization of writing requirement

By Debbi Johnstone (US), Joseph Keillor (US) and Elise LeGros (US) on March 29, 2017 Posted in Enforcement, Regulatory

On March 15, a federal district court in the Western District of Pennsylvania endorsed CMS commentary from November 2015 that dramatically liberalized the “written agreement” requirement of core Stark exceptions, thus providing some new insights as to what may be the outer limits of CMS’s new approach. When ruling on cross motions for summary judgment … Continue reading

CMS proposes Stark Law liberalizations

By Debbi Johnstone (US), Stacey Murphy (US) and Joseph Keillor (US) on July 13, 2015 Posted in Regulatory

On July 8, CMS proposed significant changes to the Stark Law via a far-reaching proposed rule and commentary that would—and in a few cases may already—eliminate numerous technical traps under the current regulatory scheme. From eliminating time limitations in connection with ‘holdovers’ of existing arrangements, to affording greater flexibility in signature timing, to clarifying that … Continue reading