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
Direct-to-consumer health and wellness applications are forewarned: the Federal Trade Commission (FTC) is proposing changes to the Health Breach Notification Rule (HBNR), 16 C.F.R. part 318, that, if finalized, would cement...more
6/9/2023
/ Breach Notification Rule ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Federal Trade Commission (FTC) ,
Health Information Technologies ,
Healthcare ,
Mobile Health Apps ,
Patient Privacy Rights ,
Policy Statement ,
Popular ,
Regulatory Agenda ,
Regulatory Reform
The Department of Health and Human Services Office for Civil Rights (OCR) issued a proposed rule on April 17, 2023, to amend provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to strengthen...more
5/26/2023
/ Abortion ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Dobbs v. Jackson Women’s Health Organization ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Healthcare Reform ,
OCR ,
Patient Privacy Rights ,
PHI ,
Pregnancy ,
Proposed Rules ,
Regulatory Agenda ,
Reproductive Healthcare Issues ,
Women's Rights
On April 11, 2023, the Department of Health and Human Services’ Office for Civil Rights (OCR) confirmed that four notifications of enforcement discretion regarding enforcement of the HIPAA Privacy, Security, and Breach...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
The Federal Trade Commission (FTC) continues to prioritize the protection of consumers’ digital health information. The agency has demonstrated this commitment through enforcement actions against GoodRx and BetterHelp for...more
4/5/2023
/ Breach Notification Rule ,
Data Collection ,
Digital Health ,
Electronic Protected Health Information (ePHI) ,
Federal Trade Commission (FTC) ,
FTC Act ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach Notification Rule ,
HIPAA Privacy Rule ,
HIPAA Security Rule ,
Life Sciences ,
New Guidance ,
Personal Information ,
Tracking Systems
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
Following its February settlement with GoodRx, the Federal Trade Commission (FTC) has fired another shot across the bow in its ongoing campaign to protect consumers’ digital health information. Earlier this month the FTC...more
3/27/2023
/ Advertising ,
Data Collection ,
Data Management ,
Data Privacy ,
Data-Sharing ,
Electronic Medical Records ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
FTC Act ,
Health Care Providers ,
Healthcare ,
Patient Privacy Rights ,
PHI ,
Unfair or Deceptive Trade Practices
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
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 Office for Civil Rights (“OCR”) at the U.S. Department of Health and Human Services (“HHS”) announced on July 15, 2022, that it has resolved 11 investigations conducted under the Health Insurance Portability and...more
Employers who are conducting automatic COVID-19 testing of employees or gathering test results of employees’ families should beware: the Equal Employment Opportunity Commission (“EEOC”) has issued new guidance limiting the...more
7/25/2022
/ Americans with Disabilities Act (ADA) ,
Anti-Discrimination Policies ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Employer Liability Issues ,
Employer Responsibilities ,
Equal Employment Opportunity Commission (EEOC) ,
GINA ,
Popular ,
Screening Procedures ,
Virus Testing ,
Workplace Safety
The U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) recently released new guidance (the “Guidance”) to help ensure that individuals may continue to benefit from audio-only telehealth...more
6/28/2022
/ Coronavirus/COVID-19 ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Healthcare Reform ,
HIPAA Security Rule ,
Infectious Diseases ,
New Guidance ,
OCR ,
Patient Access ,
Relief Measures ,
Remote Proceedings ,
Telehealth ,
Telemedicine
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