Healthcare Compliance Blog

FEBRUARY 15, 2022

This is the second largest annual total in False Claims Act history, and the largest since 2014. Congress strengthened the False Claims Act by increasing incentives for whistleblowers to file lawsuits alleging false claims on behalf of the government. More than $5.6 Total recovery now totals more than $70 billion.

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Healthcare Law Today

JANUARY 11, 2023

The government alleged that, between April 2014 and April 2019, Jet Medical introduced devices into interstate commerce that were misbranded under the Federal Food, Drug and Cosmetic Act (FDCA) because Jet Medical did not obtain approval or clearance from the U.S. Food and Drug Administration (FDA) prior to distribution.

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Healthcare Compliance Blog

MARCH 31, 2022

The agencies received millions of dollars in funding from Medicaid, which is funded in part by the federal government, and much of that money was meant to pay the wages and benefits of their aides. million to New York State for conduct between 2014–2017. million to New York State for conduct between 2014–2017.

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Med-Net Compliance

JULY 20, 2022

Specifically, between January 2014 and February 2018, the doctor billed Medicare and Medicaid approximately $585,000 and was paid approximately $191,000. Self-disclosure gives providers the opportunity to avoid the costs and disruptions associated with a government-directed investigation and civil or administrative litigation.

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Health Law Advisor

FEBRUARY 3, 2022

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.

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Verisys

MARCH 23, 2023

This is the largest amount recovered under the False Claims Act since 2014. Abuse of government healthcare programs is a federal offense with severe penalties. government or a government contractor. These referrals include any service or item payable by a government healthcare program.

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McGuire Wood

OCTOBER 12, 2023

This guidance outlines the FDA’s recommendations on improving the cybersecurity safety and effectiveness of medical devices in the premarket phase, replacing its 2014 “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” guidance.

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Provider Trust

JULY 26, 2022

District Attorney alleges that Pickering was hired in 2019 as a licensed physician’s assistant at a family practice in Norcross, Georgia but had not been a licensed physician’s assistant in Georgia, or any state, since March 2014. Chief Compliance Officer, ProviderTrust. According to the U.S. Donna Thiel. Linkedin.

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Compliancy Group

JANUARY 20, 2022

The breaches affected federal, state, local, tribal, and territorial government organizations as well as private industry organizations in the medical, legal, telecommunications, finance, and energy fields around the world. . Let’s Simplify Compliance Learn how to protect your business from breaches in our upcoming webinar!

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Med-Net Compliance

AUGUST 16, 2022

The co-defendants allegedly engaged in these acts in whole or in part, to avoid government sanctions, including a denial of payments for new admissions, additional monitoring, the imposition of civil monetary penalties, and other potential penalties.

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Hall Render

FEBRUARY 27, 2023

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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Healthcare Compliance Blog

MARCH 16, 2022

It is alleged that between January 2011 and November 2014, the Georgia nursing home submitted claims to Medicare for unreasonable, unnecessary, and unskilled services for rehabilitation therapy. The Georgia nursing home agreed to pay $400,000 to resolve the allegations. This amount was based on the nursing home’s ability to pay.

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Healthcare Law Blog

FEBRUARY 13, 2023

Inside and outside healthcare counsel should know that the way they guide clients through legal and business issues may need to change based on a recent Ninth Circuit case governing the protections afforded to attorney-client communications, In re Grand Jury. [1] 2014), the D.C. For example, consider physician compensation.

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HIT Consultant

SEPTEMBER 19, 2021

According to CRICO’s national CBS Database, 66% of malpractice cases in telemedicine from 2014 to 2018 were connected to misdiagnosis. Government cooperation. Cooperation between federal and state governments is crucial to ensure multistate licensing, payment parity, and expansion of telehealth services. Misdiagnoses.

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SQA

JUNE 10, 2021

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). Backgrounder – Government of Canada Investments in Biomanufacturing, Development of COVID-19 Vaccines and Therapeutics, and Research, 18 May 2021.

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Healthcare Law Blog

MAY 16, 2022

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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Compliancy Group

AUGUST 23, 2023

Deceiving MassHealth: The Disturbing Truth Behind Dental Services From 2014 to 2018, a shocking scheme unfolded within the realm of dental services. The sentencing of Robin Cronin serves as a reminder that those who seek to defraud government programs will be held accountable for their actions.

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SQA

JULY 8, 2022

It is not intended to provide information on the terms and procedures directly associated with regulatory requirements governing cell-based products. 536/2014 on Clinical Trials, which will replace EU Annex 13. 536/2014 on Clinical Trials replacing EU Annex 13. PIC/S Annex 13 has been revised based on EC Regulation No.

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Healthcare Law Blog

JANUARY 10, 2022

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

MAY 24, 2023

The vote occurred on 16 February 2023 following a plenary meeting of the European Parliament, and represents a significant step towards a formal extension of MDR and IVDR compliance deadlines for some device manufacturers.

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SQA

APRIL 30, 2021

The European Medical Device Coordination Group (MDCG) has issued a new document covering key questions and considerations regarding custom-made medical devices in the context of Medical Devices Regulation (MDR) compliance. These missions will allow the Commission to identify, and, if necessary, correct any non-compliance or weaknesses.

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Redox

DECEMBER 4, 2020

Immunization information systems (IIS) have received special focus as part of government health initiatives (Meaningful Use 1 and 2), so every state has one or more: More accurate information about the number of distinct IIS in the US: [link] — Lisa Bari (she/her/hers) (@lisabari) November 17, 2020. The government thought the same.

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SQA

AUGUST 2, 2021

ISO 18082:2014, Anesthetic and respiratory equipment – Dimensions of non-interchangeable screw-threaded (NIST) low pressure connectors for medical gases. government agencies and the private sector to collaborate in providing Americans with timely access to pharmaceuticals. Leveraging data to improve supply chain resilience.

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Health Law Advisor

MAY 20, 2022

FDA’s approach changed in 2014 when it issued draft guidance describing a plan to phase out FDA enforcement discretion and regulate LDTs. Laboratory compliance functions will certainly need to evolve and grow to navigate the addition of FDA requirements.

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Health Law Advisor

AUGUST 10, 2023

5] But that Interstate Commerce Clause needs to be viewed also in balance with the 10th Amendment of the Constitution, which reserves to the states any powers not delegated to the federal government. 12] FDA Draft Guidance, “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” (October 2014), available at [link]. [13]

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SQA

FEBRUARY 26, 2024

The reported irregularities and the manufacturing conditions of the products, that is, compliance with Good Manufacturing Practices, were verified on the spot. The glossary was originally published in 2014 and has been used to define excipient terms and acronyms commonly found in IPEC guides.

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Drug & Device Law

JULY 31, 2023

Since digital files were not “articles” under the statute, the government could not rely on this statute to prevent their importation. 2014 WL 46696, at *5 (C.D. 3, 2014) (claim dismissed absent any “facts to support that Defendant’s software includes physical items or is a tangible product”); Windsor Auctions, Inc. at 1291-92.

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Drug & Device Law

MARCH 29, 2022

2228 (2014), and since we do not want to suggest that POM Wonderful had any effect on preemption, we restate the distinction here. When two federal statutes are at issue, the question is one of preclusion rather than preemption. Coca-Cola Co.,

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Drug & Device Law

JANUARY 15, 2024

That is significant because, unlike (now) every other state in the country, since 1987 Pennsylvania precedent prohibited defendants from introducing evidence of their compliance with government and/or industry standards (“standards compliance” or “compliance” evidence, for short) in strict liability design defect cases – generally.

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Drug & Device Law

MARCH 13, 2023

That attempt disregards seven Pennsylvania Supreme Court decisions between 1948 ( Henderson ) and 2014 ( Lance ), as well as the Pennsylvania Superior Court (an intermediate appellate court in Pennsylvania) ( Creazzo ), all rejecting application of strict liability principles to prescription medical products. E.g. , Lewis v. 3d 357 (3d Cir.

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Drug & Device Law

MARCH 19, 2024

Plaintiff had surgery in 2014 in which the clips were used. The court also disagreed with defendants’ argument that plaintiff’s claims should be time barred because she alleges that she began experiencing symptoms soon after her surgery in 2014 and therefore, she should have discovered her injury before the statute of limitations ran in 2017.

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