The Court unanimously held that a defendant’s subjective belief is relevant to scienter under the False Claims Act, even when a defendant’s conduct is consistent with an objectively reasonable interpretation of the law....more
With the new administration poised to take office, public and private companies will need to consider how President Biden’s regulatory, enforcement, and legislative priorities will affect their businesses. During this...more
2/17/2021
/ Administrative Law Judge (ALJ) ,
Antitrust Provisions ,
Biden Administration ,
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CFIUS ,
Climate Change ,
Commodities ,
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FCC ,
Health Care Providers ,
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The Seventh Circuit has created a third standard for evaluating motions to dismiss pursuant to the government’s FCA dismissal authority.
The US Court of Appeals for the Seventh Circuit’s August 17, 2020, opinion in United...more
The 11th Circuit’s long-awaited AseraCare opinion requires more than mere disagreement regarding clinical judgment to prove falsity under the False Claims Act.
The 11th Circuit rejected the government’s theory of falsity...more
HHS proposes to remove rebates from the Anti-Kickback Statute’s “discount” safe harbor and add new safe harbor for point-of-sale discounts.
On January 31, 2019, the Department of Health and Human Services (HHS) announced a...more
2/6/2019
/ Anti-Kickback Statute ,
Congressional Investigations & Hearings ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Medicaid ,
Medicare ,
OIG ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Safe Harbors
Following a number of drug pricing reforms implemented or proposed in 2018, 2019 likely will bring more action from HHS and Congress to reduce drug prices.
Key Points:
..In 2018, the Administration implemented and...more
1/8/2019
/ Advertising ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Medicare ,
Medicare Part D ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Regulation ,
Regulatory Agenda ,
Reimbursements ,
Section 340B
Despite expected Senate revisions, the American Health Care Act poses potentially vast implications across the health care industry.
Key Points:
..The bill passed by the House would be expected to have the greatest...more
Court of Appeals panel rules use of statistical sampling is inappropriate for interlocutory appeal, leaving FCA litigants without any direct appellate court guidance.
In the closely watched case United States ex rel....more
The act creates faster, more flexible FDA drug and biologic review, new drug and device approval pathways, increases FDA funding, and reduces EHR administrative burdens.
On December 13, 2016, President Obama signed into...more
The decision in Universal Health upholds implied certification but strengthens False Claims Act defendants’ ability to mount a materiality defense.
On June 16, 2016 the U.S. Supreme Court issued a unanimous decision in...more
Oral argument in Universal Health indicates Justices disinclined to categorically reject False Claims Act implied certification theory, though may limit its scope.
On April 19, 2016, the United States Supreme Court heard...more
4/22/2016
/ Conditions of Payment ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Federal Contractors ,
Implied Certification ,
Materiality ,
Medicaid ,
Oral Argument ,
Reimbursements ,
SCOTUS ,
Split of Authority ,
Universal Health Services Inc v United States ex rel Escobar ,
Unlicensed Medical Providers
The Amarin settlement represents another important development in the FDA’s enforcement of off-label promotion.
On March 8, 2016, US District Court Judge Paul A. Engelmayer entered a Stipulation & Order of Settlement in...more
Court has the opportunity to assess the use of statistical sampling/extrapolation as a method to prove FCA liability or damages.
Courts require that plaintiffs prove each element of a legal claim with evidence — mere...more