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DOJ Releases FY 2021 False Claims Act Recoveries: A Record-Shattering Year for Health Care and Life Sciences Enforcement, with Over $5 Billion Collected

Health Law Advisor

billion, FY 2021 marks DOJ’s largest annual total FCA recovery since FY 2014, and more than twice the $2.3 According to DOJ’s statistics, the government paid out $238 million to relators in FY 2021, the lowest number since FY 2008. With collections amounting to $5.6 billion received in FY 2020. KEY TAKEAWAYS.

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DOJ Recouped $2.2 Billion Under FCA in 2022

Hall Render

Whistleblowers continue to be one of the federal government’s greatest assets in FCA cases, as whistleblowers filed 652 qui tam suits in 2022 with recovery totaling $1.9 The government initiated 296 FCA cases on its own last year without input of a relator, which is the highest volume of DOJ initiated cases since the 1986 FCA amendments.

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SQA Regulatory Surveillance Summary 4 | Monthly Update 2021

SQA

Due to the COVID-19 pandemic, there was an increase of 39.2% Commission in March 2015 after the publication, in December 2014, of the Q3D Guideline on Elemental Impurities (EI) by the International Council for Harmonization (ICH). The Government of Canada’s number one priority is to protect the health of Canadians.

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CMS Issues Contract Year 2023 Final Rule for Medicare Advantage Organizations and Prescription Drug Sponsors

Healthcare Law Blog

Enrollee Participation in Dual Eligible Special Needs Plan (“D-SNP”) Governance (§ 422.107). CMS believes its proposals would improve Federal and State oversight of D-SNPs (and their affiliated MCOs) through greater information-sharing among government regulators. A warning letter = 3 points. A notice of noncompliance = 1 point.

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CMS’ Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs

Healthcare Law Blog

Enrollee Participation in Plan Governance (§ 422.107). CMS believes its proposals would improve Federal and State oversight of certain D-SNPs (and their affiliated MCOs) through greater information-sharing among government regulators. Key provisions of the Proposed Rule are summarized below. Comments are due by March 7, 2022.

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SQA Regulatory Surveillance Summary 3 | Monthly Update 2021

SQA

Commission Extends Transparency and Authorization Mechanism for Exports of COVID-19 Vaccines, 11 March 2021. The EC has extended until the end of June 2021 the transparency and authorization mechanism for COVID-19 vaccine exports. The mechanism provides for authorizations of exports of COVID-19 vaccines outside the EU.

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SQA Regulatory Surveillance Summary 5 | Monthly Update 2021

SQA

COVID-19 Response: Freely Available ISO Standards, 18 June 2021. A number of ISO standards have been made available to support global efforts to address the COVID-19 crisis. government agencies and the private sector to collaborate in providing Americans with timely access to pharmaceuticals.

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