Joseph Keillor (US)

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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

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

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

CMS rings in the new year with overhaul of MSSP ACOs

On December 21, 2018, CMS issued a mammoth 957 page “Pathways to Success” final rule, which overhauls shared savings/losses tracks for Medicare Shared Savings Program Accountable Care Organizations (MSSP ACOs) to push ACOs into shared risk models more quickly, among other program changes. Largely consistent with the proposed rule as we summarized here, the final … Continue reading

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

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 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

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

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)

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

Federal district court endorses Stark liberalization of writing requirement

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

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

Joint venture developments in chinese hospital market

Two recent joint ventures demonstrate potential opportunities for health care providers to expand into the Chinese market. The first venture involves Raffles Medical Group, a large Singapore-based health care provider, collaborating with Shanghai LuJiaZui (Group) Co, Ltd., a China real estate developer, to build a 400-bed, full-service hospital in the New Bund International Business District … Continue reading

OIG publishes compliance oversight guidance for health care governing boards

On April 20, 2015, the HHS Office of Inspector General (OIG) published guidance for health care governing boards, articulating general features of effective compliance oversight and highlighting specific practical approaches available to boards. The guidance encourages organizations to draw functional boundaries in organizational documents between the compliance, legal, and internal audit functions, while also “setting … Continue reading
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