For the first time ever, a judge has ruled that the qui tam provision of the False Claims Act (FCA), which whistleblowers have used to recover $52 billion on behalf of the government since 1986, is unconstitutional....more
Mifepristone is safe for now. On June 13, 2024, the Supreme Court unanimously held that the plaintiffs — doctors and medical associations alike — lacked standing to challenge 2000 and 2019 FDA approvals of mifepristone (brand...more
6/18/2024
/ Abortion ,
Alliance for Hippocratic Medicine v Food and Drug Administration ,
Article III ,
Dobbs v. Jackson Women’s Health Organization ,
EMTALA ,
Equal Protection ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Human Rights ,
Life Sciences ,
Medical Necessity ,
Patient Access ,
Pregnancy ,
Prescription Drugs ,
Reproductive Healthcare Issues ,
Roe v Wade ,
SCOTUS ,
Standing ,
Women's Rights
By maintaining a robust compliance program, healthcare companies are better able to identify potential red flags early and to prevent violations of fraud and abuse laws. A failure to maintain an effective compliance program...more
1/30/2024
/ Compliance Management Systems ,
Corporate Sales Transactions ,
Department of Justice (DOJ) ,
Federal Trade Commission (FTC) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Hospital Mergers ,
OIG ,
Safe Harbors
How could alleged kickbacks threaten to render insolvent a publicly traded company with assets (taken from its latest SEC filing) in excess of $43 billion? The answer stems from a recent decision by the United States District...more
8/10/2023
/ Anti-Kickback Statute ,
Co-payments ,
False Claims Act (FCA) ,
False Statements ,
Health Insurance ,
Healthcare ,
Kickbacks ,
Medicare ,
Patient Assistance Programs ,
Pharmaceutical Industry ,
Publicly-Traded Companies ,
Securities and Exchange Commission (SEC) ,
Teva Pharmaceuticals
For the second time this month, the United States Supreme Court addressed a circuit split involving the False Claims Act (FCA, 31 U.S.C. §§ 3729 – 3733). Earlier, in the SuperValu decision (discussed in a recent Health Law Rx...more
Yesterday, the United States Supreme Court held that a False Claims Act (FCA) defendant cannot rely on an objectively reasonable interpretation of a law, regulation, or rule to negate the scienter element of the FCA. In...more
6/2/2023
/ Drug Pricing ,
False Claims Act (FCA) ,
Healthcare ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Reasonable Interpretations ,
Safeco ,
Safeco Insurance Co of America v Burr ,
Scienter ,
SCOTUS ,
US ex rel Thomas Proctor v Safeway Inc ,
US ex rel Tracy Schutte et al v SuperValu Inc et al
The U.S. government continued to earn its longstanding reputation for its vigorous enforcement of the False Claims Act (FCA) in 2022, either directly or through relator proxies. The Department of Justice (DOJ) recorded the...more
4/18/2023
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Fraud ,
Popular ,
Stark Law
There are multiple components to the risk defendants must consider when faced with going to trial for a matter involving the False Claims Act (FCA). Setting aside the incalculable impact that litigation can have on business...more
3/30/2023
/ Anti-Kickback Statute ,
Damages ,
Department of Justice (DOJ) ,
Eighth Amendment ,
Enforcement Actions ,
Excessive Fines Clause ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Fraud ,
Kickbacks ,
Medicaid ,
Medicare ,
Statutory Violations
Are State Attorneys General expanding their reach in this Post-Dobbs world? On February 1, 2023, twenty state Attorneys General signed letters to both CVS and Walgreens warning the giant retail pharmacies against mailing...more
2/13/2023
/ Abortion ,
CVS ,
Dobbs v. Jackson Women’s Health Organization ,
Enforcement Guidance ,
Healthcare ,
Patient Access ,
Pharmaceutical Industry ,
Pharmacies ,
Racketeering ,
Reproductive Healthcare Issues ,
RICO ,
Roe v Wade ,
State and Local Government ,
State Attorneys General ,
Statutory Violations ,
Walgreens ,
Warning Letters
What does it mean to “knowingly” or “recklessly” violate the law when that law consists of highly complex and ever-changing regulations, which may be open to interpretation? The U.S. Supreme Court recently agreed to review...more
2/1/2023
/ Case Consolidation ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Relators ,
Scienter ,
SCOTUS ,
US ex rel Thomas Proctor v Safeway Inc ,
US ex rel Tracy Schutte et al v SuperValu Inc et al ,
Whistleblowers
Ruling on the State of Georgia’s November 18, 2022 Emergency Petition for Supersedeas, this past Wednesday (November 23, 2022) the Georgia Supreme Court enjoined the lower court’s decision thereby reinstating the prohibitions...more
11/30/2022
/ Abortion ,
Dobbs v. Jackson Women’s Health Organization ,
Equal Protection ,
GA Supreme Court ,
Georgia ,
Healthcare ,
Motion To Enjoin ,
Patient Access ,
Pregnancy ,
Reproductive Healthcare Issues ,
Roe v Wade ,
SCOTUS ,
State Constitutions
On June 24, 2022, the United States Supreme Court issued its seminal decision on abortion, Dobbs v. Jackson Women’s Health Organization, overturning Roe v. Wade and the right to terminate a pregnancy before viability, which...more
11/18/2022
/ Abortion ,
Constitutional Challenges ,
Dobbs v. Jackson Women’s Health Organization ,
Georgia ,
Healthcare ,
Patient Access ,
Pregnancy ,
Reproductive Healthcare Issues ,
Roe v Wade ,
State Constitutions ,
Women's Rights
Two recent multi-million dollar False Claims Act (“FCA”) settlements demonstrate the vigor with which the Department of Justice (“DOJ”) is investigating and prosecuting allegedly fraudulent health care billing practices....more
The Supreme Court’s landmark decision in Dobbs v. Jackson Women’s Health Organization represents a sea-change in Constitutional law that has already impacted our country in multiple ways. By overruling Roe v. Wade (1973)...more
8/19/2022
/ Abortion ,
Dobbs v. Jackson Women’s Health Organization ,
EMTALA ,
Health Care Providers ,
Healthcare ,
New Guidance ,
Patient Access ,
Popular ,
Pregnancy ,
Reproductive Healthcare Issues ,
Roe v Wade ,
SCOTUS