North America

Tenth Circuit Holds That the False Claims Act Does Not Protect Post-Employment Retaliation

On November 6, 2018, the U.S. Court of Appeals for the Tenth Circuit handed down a decision that impacts employers across all industries, including the financial services industry. In a “win” for employers, the Tenth Circuit ruled that “…the False Claims Act’s anti-retaliation provision unambiguously excludes relief for retaliatory acts which occur after the employee has left employment.” Potts v. Center for Excellence in Higher Education, Inc., No. 17-1143 (10th Cir. Nov. 6, 2018).

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Can I Bring Cannabis from Canada Home?

Cannabis has been legalized in Canada as of October 17, 2018. What does this mean for employers with employees traveling to and from Canada? Can travelers from Canada to the United States with legally purchased cannabis simply drive to a state where recreational or medical use of cannabis is legal? The bottom line: Employers should remind employees that they cannot cross into the United States with Canadian cannabis under any circumstances.

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The Pursuit of Truth in Advertising: Regulatory

As mentioned in my previous blog post, I gave a presentation at the 40th Annual Association of National Advertisers/Brand Activation Association Marketing Law Conference titled “The Pursuit of ‘Truth’ in Advertising.” It explored how consumers view the truth in this era of fake news and alternative facts, and how this changing understanding of the truth has affected the advertising ecosystem and the practice of advertising law. Today, I will share the second installment in my series of highlights from my presentation.

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No presumption of lessor’s liability in case of fire

In 9192-2401 Québec inc. (Fabricaon Pro-Fab) c. Villeneuve (Immeubles Jolika), 2018 QCCA 1143, the Court of Appeal underlined that in a claim by a lessee against a lessor, in virtue of arcle 1854 CCQ, the lessee must prove that the damages were caused by either a defect, a default or a failure of the leased property.

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New York’s High Court Strikes Down Governor Cuomo’s “Soft Cap” on Executive Compensation for Health Care Providers Receiving State Funds, Yet Upholds Limitations

Last month, the New York State Court of Appeals invalidated a state Department of Health (DOH) regulation that restricted certain health care providers contracting with the state from paying executives more than $199,000 annually, regardless of whether the funds came from the state or not. However, the Court upheld two other DOH regulations; one that limits providers from using public tax-payer money directly to pay executives in excess of $199,000 annually, and another that limits the amount of public funds used for administrative costs.

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Sales and Marketing Compliance: New Federal Anti-Kickback Law May Alter How Clinical Laboratories Compensate Sales Personnel

Clinical laboratories need to review how they compensate sales personnel following the passage of the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”) (Section 8122 of the SUPPORT Act) which is effective as of October 24, 2018.  The SUPPORT Act is a combination of more than 70 bills aimed at fighting the opioid epidemic, with EKRA intended to address patient brokering in exchange for kickbacks of individuals with substance abuse disorders.  However, as written, EKRA is far more expansive.

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Top Five Takeaways from MedPAC’s Meeting on Medicare Issues and Policy Developments – November 2018

The Medicare Payment Advisory Commission (“MedPAC”) held its monthly public meetings in Washington, D.C., on November 1-2, 2018. The purpose of this and other MedPAC public meetings is for the commissioners to analyze existing challenges and issues within the Medicare program and to provide future policy recommendations to Congress. MedPAC issues these recommendations in two annual reports, one in March and another in June. These meetings offer a comprehensive perspective on the current state of Medicare as well as future outlooks for the program.

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FDA Loosens the Reins on Informed Consent Requirements for Certain Clinical Studies

Following up on its July 2017 guidance on the same topic (discussed in a previous blog post), FDA issued a proposed rule on November 15, 2018 to amend Agency regulations to allow Institutional Review Boards (“IRBs”) to waive or alter certain informed consent elements (or in some cases, waive the informed consent requirement altogether) for FDA-regulated, minimal risk clinical investigations (“Proposed Rule”).

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Hospitals Need to Be Aware of CMS Changes to PAMA

The Centers for Medicare & Medicaid Services (CMS) issued a final rule on November 1, 2018 that updates physician fee schedule (PFS) payments for calendar year (CY) 2019 and finalizes several policies. The final rule includes amendments to the regulations promulgated under Section 216 of the Protecting Access to Medicare Act of 2014 (“PAMA”) intended to increase the number of clinical laboratories that qualify as an “applicable laboratory” for reporting purposes; specifically (1) removal of payments received from Medicare Advantage (MA) Plans for determining applicable laboratory status and (2) the use of the Form CMS-1450 14x Type of Bill (TOB) to define an applicable laboratory.

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Dental Practice and Related Management Company Settle Medicaid Fraud Claims, Become the First Entities on the OIG’s New “High Risk – Heightened Scrutiny” List

A dental practice and related dental management company have become the first two entities to make their way on to the newly created “High Risk – Heightened Scrutiny” list from the Office of Inspector General for the United States Department of Health and Human Services (the “OIG”).[1]

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