Articles and Blogs

Year: 2017

Courts Return to Real Particularity to Meet Rule 9(b)’s “Fraud with Particularity” Requirement

[02/02/17]

Posted on February 2, 2017 in False Claims Act Defense

Published by: Hall Render

The courts appear to be walking back their trend toward loosening False Claims Act (“FCA”) pleading requirements. The FCA is a fraud statute, and lawsuits alleging FCA violations must be pled under Rule 9(b) of the Federal Rules of Civil Procedure: Fraud or Mistake; Conditions of Mind. In alleging fraud or mistake, a party must state... READ MORE

Statistical Evidence and the False Claims Act

[02/02/17]

Posted on February 2, 2017 in False Claims Act Defense

Published by: Hall Render

The False Claims Act¹ is a fraud statute; therefore, False Claims Act complaints must be pled with particularity,² identifying “the who, what, when, where, and how of an actual false claim” submitted to the government.³ Whistleblowers without evidence of specific claims have tried to circumvent the rule with statistics, showing a likelihood that false... READ MORE

CMS Finalizes New Conditions of Participation for Home Health: Part 5

[02/01/17]

Posted on February 1, 2017 in Health Law News, Long-Term Care, Home Health & Hospice

Published by: Hall Render

Review of the New Home Health Conditions of Participation – Patient Rights (part 2). This is the fifth article in a series discussing CMS’s Final Revised Home Health Conditions of Participation (“Final CoPs”). With the release of the Final CoPs, CMS is finalizing the significant changes they proposed to make to the home health... READ MORE

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340B “Mega-Guidance” Withdrawn – Next Steps Unclear

[02/01/17]

Posted on February 1, 2017 in Health Law News

Published by: Hall Render

On Monday, January 30, 2017, the Department of Health and Human Services Health Resources and Services Administration (“HRSA”) withdrew its 340B Program Omnibus Guidance, also referred to as the “Mega-Guidance.” The guidance would have addressed questions and provided clarifications for enrolled covered entities, drug manufacturers and contract pharmacies participating in the 340B Program. The... READ MORE

Third Immigration Executive Order Signed

[01/30/17]

Posted on January 30, 2017 in Health Law News

Published by: Hall Render

On Friday, January 27, 2017, President Trump signed a third executive order dealing with immigration titled, “Protecting the Nation from Foreign Terrorist Entry into the United States.” The provisions contained in the order impose a 90-day ban on entry for all nationals of seven named countries. The order also imposes a halt for all... READ MORE

CMS Finalizes New Conditions of Participation for Home Health: Part 4

[01/30/17]

Posted on January 30, 2017 in Health Law News, Long-Term Care, Home Health & Hospice

Published by: Hall Render

Review of the New Home Health Conditions of Participation – Patient Rights. This is the fourth article in a series discussing CMS’s Final Revised Home Health Conditions of Participation (“Final CoPs”). With the release of the Final CoPs, CMS is finalizing the significant changes they proposed to make to the home health CoPs in... READ MORE

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Proposed Michigan Legislation Expands Protections to Health Care Workers

[01/30/17]

Posted on January 30, 2017 in Health Law News

Published by: Hall Render

On January 18, 2017, Senate Bill 33 (“SB 33”) was introduced in the Michigan Senate by Senator Kenneth Horn (R – Frankenmuth). SB 33 would amend the Michigan penal code by imposing felony charges against any individual who assaults, batters, wounds, resists, obstructs, opposes or endangers emergency room personnel performing their duties. The current... READ MORE

Hall Render’s This Week in Washington – January 27, 2017

[01/27/17]

Posted on January 27, 2017 in Federal Advocacy

Published by: Hall Render

Trump Signs Executive Order Intended to Expedite ACA Repeal Process Hours after being sworn in as the 45th President of the United States, Donald Trump  signed an executive order that marks his administration’s first step towards unraveling the Affordable Care Act (“ACA”). The order instructs all agencies in the executive branch to “waive, defer, grant... READ MORE

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U.S. District Court Blocks $37 Billion Aetna/Humana Merger; Decision Looming in Anthem/Cigna

[01/27/17]

Posted on January 27, 2017 in Health Law News

Published by: Hall Render

On January 23, 2017, following a 13-day trial, the U.S. District Court for the District of Columbia (the “Court”) ruled in favor of the U.S. Department of Justice (“DOJ”) in the government’s suit to block the $37 billion insurance mega merger between Aetna Inc. (“Aetna”) and Humana Inc. (“Humana”). It is expected that a... READ MORE

President Trump Issues Executive Orders on Immigration Policies

[01/26/17]

Posted on January 26, 2017 in Health Law News

Published by: Hall Render

As you may know, President Trump signed a pair of executive orders recently regarding immigration policies and enforcement. While his orders may have a sweeping effect on immigration as a whole, employment-based immigration processes are not overtly changed. Below is a brief summary of provisions of the executive orders and the draft order that... READ MORE

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