In recent months, six different lawsuits have been filed challenging the Inflation Reduction Act (IRA)’s Drug Price Negotiation Program (the “Program”), with a flurry of activity likely in the coming months before the...more
7/25/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Excise Tax ,
Fifth Amendment ,
First Amendment ,
Inflation Reduction Act (IRA) ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Prescription Drugs ,
Unconstitutional Condition
On June 16, 2023, the Supreme Court issued a decision in United States ex rel. Polansky v. Executive Health Resources, Inc., giving the United States government broad power to dismiss qui tam FCA lawsuits even when it has...more
On June 1, 2023, the Supreme Court issued a decision in United States ex rel. Schutte v. SuperValu, Inc., clarifying when a defendant “knowingly” submits a false claim for payment under the False Claims Act (FCA). The Court...more
6/6/2023
/ Drug Pricing ,
False Claims Act (FCA) ,
Healthcare ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Scienter ,
SCOTUS ,
US ex rel Tracy Schutte et al v SuperValu Inc et al
On May 9, 2023, President Biden issued a highly anticipated Executive Order formally revoking the federal contractor COVID-19 vaccine mandate (Executive Order 14042) and the federal employee COVID-19 vaccine mandate...more
On April 19, 2023, the U.S. Court of Appeals for the Ninth Circuit deviated from its sister circuits and reversed the Arizona district court’s preliminary injunction of the contractor COVID-19 vaccine mandate issued pursuant...more
Appeals for the Sixth Circuit joined the Fifth and Eleventh Circuits in upholding a preliminary injunction against the enforcement of the Biden Administration’s effort to impose on federal contractors a variety of COVID-19...more
On Friday, January 13, the Supreme Court agreed to consider whether the False Claims Act (“FCA”) covers compliance lapses tied to regulatory interpretations that are incorrect but “objectively reasonable.” The Supreme Court...more
1/18/2023
/ Billing ,
Certiorari ,
False Claims Act (FCA) ,
Fraud ,
Medicare ,
Misrepresentation ,
Oral Argument ,
Reckless Disregard ,
Scienter ,
SCOTUS ,
Statutory Interpretation
The Supreme Court just agreed to review an important question at the intersection of arbitration law and appellate practice. Its ultimate decision in the case could provide a major boost to defendants seeking to enforce...more
On October 14, 2022, the Safer Federal Workforce Task Force (“Task Force”) published yet another update for Federal contractors regarding the Federal Government’s approach to enforcing Executive Order 14042 (“EO 14042”) in...more
In a long-awaited decision, on August 26, 2022, the United States Court of Appeals for the Eleventh Circuit significantly narrowed the scope of a nationwide preliminary injunction of the vaccine mandate in Executive Order...more
In a long-awaited decision, on August 26, 2022, the United States Court of Appeals for the Eleventh Circuit significantly narrowed the scope of a nationwide preliminary injunction of the vaccine mandate in Executive Order...more
The Ninth Circuit gets more requests to appeal class-certification decisions under Rule 23(f) than any other court. How do those requests fare? We take a look below, drawing from this invaluable nationwide study by...more
Lawyers for the U.S. government and challengers to the federal contractor vaccine mandate both faced tough questions from an Eleventh Circuit panel in Atlanta, Georgia on Friday, April 8, 2022....more
It has been more than two months since the U.S. District Court for the Southern District of Georgia issued a nationwide preliminary injunction of Executive Order 14042, the Biden Administration’s effort to impose a vaccine...more
On January 27, 2022, the U.S. District Court for the District of Arizona joined the growing list of courts that have preliminarily enjoined Executive Order 14042 (which imposes COVID safety protocols on government...more
As a result of the U.S. District Court for the Southern District of Georgia’s latest order, which confirms the nationwide preliminary injunction of Executive Order 14042 (“EO” or “EO 14042”) applies only to the “vaccine...more
On Friday afternoon, the U.S. District Court for the Southern District of Georgia, which had earlier issued a nationwide preliminary injunction against Executive Order 14042’s vaccine mandate, made clear that the injunction...more
What happens when two courts of appeal each think the other has exclusive jurisdiction over an appeal? Confusion and inter-circuit criticism. The latest chapter in such a dispute between the Federal and Fifth Circuits on the...more
The Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) is looking alive and well after last week’s Supreme Court oral argument on the Affordable Care Act (“ACA”).
If you didn’t realize the BPCIA was at issue...more
11/18/2020
/ Affordable Care Act ,
Amicus Briefs ,
Biologics ,
Biosimilars ,
BPCIA ,
California v Texas ,
Individual Mandate ,
Oral Argument ,
Preexisting Conditions ,
SCOTUS ,
Severability Doctrine
How well do Federal Circuit decisions hold up at the Supreme Court? And which Federal Circuit judges have their votes most often affirmed? With the new Supreme Court term around the corner, we dove into a decade’s worth of...more
Is it just us or does March 4 — the date of our last issue — feel like a million years ago? Like you, and not necessarily in this order, we have been: doing our work; keeping up with COVID-19-related laws, guidance, and...more
7/15/2020
/ Advanced Notice of Proposed Rulemaking (ANPRM) ,
Arbitration ,
Auto-Dialed Calls ,
BSA/AML ,
CARES Act ,
Consent Order ,
Consumer Financial Protection Bureau (CFPB) ,
Coronavirus/COVID-19 ,
CRA ,
Dodd-Frank ,
E-SIGN ,
Fair Lending ,
FASB ,
FDIC ,
Federal Reserve ,
FinCEN ,
FinTech ,
HMDA ,
Interim Final Rules (IFR) ,
Money Market Mutual Fund Liquidity Facility (MMLF) ,
OCC ,
Paycheck Protection Program Lending Facility (PPPLF) ,
Popular ,
Remittance Transfer Rule ,
Request For Information ,
RESPA ,
SPVs ,
TCPA ,
Volcker Rule
On June 29, 2020, the U.S. Supreme Court issued its ruling in Seila Law LLC v. Consumer Financial Protection Bureau, holding that the CFPB’s leadership structure—with a single director removable only for inefficiency,...more
BID PROTESTS, LATEST DEVELOPMENTS & TWISTS -
Bid Protests: Agenda -
1. LOGCAP V and Task/Delivery Order Protest Jurisdiction
2. SpaceX and Other Transaction Authority Protest Jurisdiction
3. Potential Impact of New...more
On September 17, 2019, two developments took place with respect to the constitutionality of the structure of the Consumer Financial Protection Bureau (CFPB or Bureau), an issue that has been litigated for several years....more
EDITOR’S NOTE -
So much for the lazy days of summer. It’s been a busy couple of months on both coasts. In a case of déjà vu all over again, a New York federal court found that the CFPB structure is unconstitutional and that...more
9/12/2018
/ Arbitration ,
BSA/AML ,
Consent Order ,
Consumer Financial Protection Bureau (CFPB) ,
Fair Credit Reporting Act (FCRA) ,
Fair Lending ,
Financial Services Industry ,
FinTech ,
Fixing America’s Surface Transportation Act (FAST Act) ,
Mortgages ,
OCC ,
RMBS ,
TCPA ,
U.S. Treasury ,
Volcker Rule