Practitioners who want to prescribe controlled substances via telehealth to patients in Florida must meet the requirements of both federal and state law. The federal Drug Enforcement Administration (DEA) and the Florida...more
The Department of Health and Human Services (HHS) recently rescinded its policy dating back to 1971 to now allow its agencies and offices to quickly alter certain rules and regulations without public notice and comment. The...more
The Department of Justice (DOJ) released its annual False Claims Act (FCA) enforcement statistics on January 15, 2025, announcing that it had recovered in excess of $2.9 billion from FCA resolutions during Fiscal Year (FY)...more
2/3/2025
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Medicare ,
Medicare Advantage ,
Qui Tam ,
Stark Law ,
Whistleblowers
As we anticipated in our October 17, 2024, blog, both the Government and the Relator have appealed the district court’s decision in U.S. ex rel. Zafirov v. Florida Medical Associates, LLC, et al. (Zafirov), the first case to...more
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
The three federal agencies tasked with enforcement of the Mental Health Parity and Addiction Equity Act (MHPAEA) — the Departments of Labor, Health & Human Services (through CMS), and Treasury (the Departments) — issued their...more
9/20/2024
/ Benefit Plan Sponsors ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Employee Benefits ,
Employee Retirement Income Security Act (ERISA) ,
Employer Group Health Plans ,
Health Insurance ,
Mental Health ,
Mental Health Parity Rule ,
MHPAEA ,
Substance Abuse
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
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
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
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
Currently, providers have different risks of potential False Claims Act (“FCA”) liability depending on where they are geographically located due to the difference in the standards required by the U.S. Courts of Appeals...more
6/17/2022
/ Burden of Proof ,
Criminal Liability ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Motion to Dismiss ,
Pleading Standards ,
Relators ,
Rule 9(b) ,
Treble Damages
The Biden Administration’s proposed budget for fiscal year 2023 serves as a warning to all plan issuers and administrators that enforcement of the Mental Health Parity and Addiction Equity Act (MHPAEA) is a top priority for...more
6/15/2022
/ Biden Administration ,
Department of Labor (DOL) ,
Employee Retirement Income Security Act (ERISA) ,
Employer Group Health Plans ,
Enforcement Actions ,
Federal Budget ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Mental Health ,
Mental Health Parity Rule ,
MHPAEA ,
NQTLs
For the first time since 2013, on November 8, 2021, the Department of Health and Human Services Office of Inspector General (“OIG”) updated its Health Care Fraud Self-Disclosure Protocol (“SDP”). The updated SDP makes several...more
The U.S. Department of Justice (“DOJ”) has settled six qui tam lawsuits brought in various jurisdictions by whistleblowers against a private equity firm and its portfolio healthcare companies. ...more
Data collected during the coronavirus pandemic shows a disturbing trend of inequities in testing and treatment for COVID-19 among people of color. On July 20, 2020 the Department of Health and Human Services’ (HHS) Office for...more
8/11/2020
/ Civil Rights Act ,
Coronavirus/COVID-19 ,
Data Collection ,
Department of Health and Human Services (HHS) ,
Disparate Impact ,
Health Care Providers ,
National Origin Discrimination ,
New Guidance ,
OCR ,
Race Discrimination ,
Title VI ,
Virus Testing
Novartis Pharmaceuticals Corporation (Novartis) has started July with significant settlements, putting two different fraud and abuse matters behind them. In what has been identified as the largest settlement of an...more
7/22/2020
/ Anti-Kickback Statute ,
Bribery ,
Compliance ,
Corporate Integrity Agreement ,
Corruption ,
Foreign Corrupt Practices Act (FCPA) ,
Life Sciences ,
Novartis ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Settlement Agreements ,
White Collar Crimes
Despite Congress’ efforts to use riders to neutralize a provision of the Affordable Care Act (ACA or Act), the Federal government (Government) owes certain insurers $12 billion....more
5/4/2020
/ Affordable Care Act ,
Appropriations Bill ,
Court of Federal Claims ,
Damages ,
Government Payments ,
Health Insurance ,
Maine Community Health Options v. United States ,
Moda Health Plan Inc. v. United States ,
Reimbursements ,
Remand ,
Repeal ,
Reversal ,
Risk Corridors Statute ,
SCOTUS ,
Tucker Act
The Eleventh Circuit Court of Appeals, in its ruling in Cochise Consultancy Inc. v. U.S. ex rel. Hunt, created a 3-way circuit split regarding the determination of the applicable statute of limitations period in a False...more