The FCA Insider

Insights and updates on False Claims Act Litigation

Category Archives: CMS Guidance

OIG, Stark Law September 10, 2020

HHS Extends Timeline to finalize Stark Law Changes and CMP Inflation Rule

In the last two weeks, the U.S. Department of Health and Human Services (HHS) published two notices in the Federal Register delaying the publication of certain final fraud and abuse rule reforms for up to a full year. First, in the Aug. 27 Federal Register, the Centers for Medicare & Medicaid Services (CMS) delayed the… Continue Reading

CMS Guidance, Stark Law June 22, 2020

Stark Law 2019 Settlements Continue Downward Trend

The number and value of announced settlements with the Centers for Medicare & Medicaid Services (CMS) concerning the physician self-referral law (the Stark Law) continued a downward trend in 2019. This marks the third straight year of such aggregate settlement declines since reaching a peak in 2016. Indeed, as shown on the first chart below,… Continue Reading

CMS Guidance, Regulatory, Stark Law May 2, 2020

CMS Issues Explanatory Guidance on Stark Law Blanket Waivers During COVID-19 Pandemic

On April 21, 2020, the Centers for Medicare & Medicaid Services (CMS) issued guidance on the scope and application of the blanket waivers to the Physician Self-Referral Law (Stark Law) issued by the Department of Health and Human Services (HHS) on March 30, 2020, for use during the 2019 novel coronavirus (COVID-19) public health emergency.… Continue Reading

CMS Guidance, Regulatory, Stark Law April 4, 2020

Stark Law Waivers Issued During COVID-19 Pandemic

On March 30, 2020, Department of Health and Human Services Secretary Alex Azar issued blanket waivers to permit certain financial relationships and referrals that would otherwise be sanctioned by the Physician Self-Referral Law (Stark Law). The blanket waivers protect those financial relationships and referrals (and the claims submitted as a result thereof) specifically enumerated by… Continue Reading

CMS Guidance, Regulatory November 27, 2019

CMS Internal Memorandum Clarifies Impact of Supreme Court Decision on Enforcement Practices

The Deputy General Counsel and Chief Legal Officers at the U.S. Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) recently issued an Internal Memorandum clarifying that a recent Supreme Court ruling may limit HHS’s enforcement practices going forward. Consistent with the Court’s ruling, the Memorandum clarifies that subregulatory guidance… Continue Reading

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