Overview of Qui Tam Activity -
..We identified 56 health care related qui tam cases that were unsealed in October and November 2017.
..The intervention rate for those unsealed cases was 20%, which is consistent with...more
The U.S. Department of Health and Human Services Office for Civil Rights (OCR) recently announced a $100,000 settlement with a company that is no longer in business. Filefax, Inc. (Filefax) was an Illinois company that...more
As we look back on 2017, one message is clear: don’t be a Scrooge when it comes to HIPAA compliance. With ever-evolving security threats and unrelenting enforcement, regulated entities must maintain a spirit of compliance...more
The U.S. Court of Appeals for the Fifth Circuit recently decided a case that could have a substantial impact on False Claims Act (“FCA”) jurisprudence with respect to the element of “materiality.” In U.S. ex rel. Joshua...more
11/30/2017
/ Attorney's Fees ,
Department of Justice (DOJ) ,
Department of Transportation (DOT) ,
Disclosure Requirements ,
False Claims Act (FCA) ,
False-Certification of Conformance ,
Federal Highway Administration ,
Federal Rule 12(b)(6) ,
Material Misstatements ,
Materiality ,
Qui Tam ,
Reimbursements ,
Universal Health Services Inc v United States ex rel Escobar ,
Whistleblowers ,
Writ of Mandamus
As Texas, Florida, and the Caribbean rebuild after the latest string of deadly hurricanes and prepare for the possibility of future storms, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR)...more
9/19/2017
/ Cybersecurity ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospitals ,
Hurricane Harvey ,
Hurricane Irma ,
Natural Disasters ,
OCR ,
Personally Identifiable Information ,
Waivers
A court in the Southern District of New York (“SDNY” or the “Court”) recently released an important decision applying the Supreme Court’s landmark Escobar ruling to a qui tam action involving percentage fee arrangements for...more
Continuing its annual tradition, the U.S. Department of Justice (“DOJ”) and the U.S. Department of Health and Human Services (“HHS”) announced last week the largest ever health care fraud enforcement action by the Medicare...more
OCR released a simple checklist and infographic last week to assist Covered Entities and Business Associates with responding to potential cyber attacks. As cybersecurity remains a pressing concern for health care entities,...more
6/14/2017
/ Business Associates ,
Covered Entities ,
Cyber Attacks ,
Cybersecurity ,
Data Breach ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Federal Breach Notification Standard ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
ISAOs ,
OCR ,
PHI ,
Popular
The U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced another large HIPAA-related settlement last week with Memorial Hermann Health System (Memorial Hermann), the largest not-for-profit...more
On May 11, 2017, the Senate Health, Education, Labor and Pension (HELP) Committee voted in support of the FDA Reauthorization Act of 2017, or FDARA, now formally moving through the legislative process as S. 934. The committee...more
We recently updated our chart that tracks state biosimilar substitution laws to include new laws in Iowa and Montana. These new laws bring the total number of states with biosimilar substitution laws to 27, plus Puerto Rico....more
4/20/2017
/ Biologics ,
Biosimilars ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Medicaid ,
Medicare ,
New Legislation ,
Pharmaceutical Industry ,
Pharmacist ,
Prescription Drugs ,
Sandoz v Amgen
Trends & Analysis -
..This issue looks at 18 health care–related qui tam cases that were unsealed in whole or in part in late October through November 2016.
..The cases identified were filed in federal district courts...more
Featured Unsealed Cases
United States ex rel. Thomas v. Best Choice Home Health Care Agency, Inc., No. 2:13-cv-02209 (D. Kan.) -
Complaint Filed: May 6, 2013 -
Complaint Unsealed: October 24, 2016...more
3/17/2017
/ Anti-Retaliation Provisions ,
Civil Penalty Fund ,
Co-Conspirators ,
Corporate Integrity Agreement ,
Criminal Penalties ,
Dismissals ,
False Billing ,
False Claims Act (FCA) ,
False-Certification of Conformance ,
Former Employee ,
Guilty Pleas ,
Home Health Care ,
Intervenors ,
Kickbacks ,
Medicaid ,
Medicare ,
Qui Tam ,
Relators ,
Stark Law ,
State False Claims Acts ,
Whistleblowers
As we’ve previously discussed on Health Law and Policy Matters, agencies within the Department of Health and Human Services (DHHS) pushed through several final rules towards the end of the Obama Administration. However, since...more
The U.S. Department of Health and Human Services, Office for Civil Rights (OCR) recently announced the first ever settlement related to a Covered Entity’s untimely breach notification in violation of HIPAA. Presence Health,...more
On Tuesday, President Obama signed the 21st Century Cures Act (the “Act”) into law. The Act is a massive piece of legislation that has implications for many different aspects of the interconnected medical research, product...more
In non-election news, the Office for Civil Rights (OCR) at the Department of Health and Human Services recently released its November Cyber Awareness Newsletter. This month’s newsletter focuses on the topic of...more
Although National Cyber Security Month isn’t until October, September has brought plenty of privacy and security updates that health care companies need to be aware of. In this post, we review guidance from the Office for...more
As we predicted in a previous post, FDA approved a new biosimilar product, Sandoz’s Erelzi (etanercept-szzs), which is a biosimilar to Amgen’s Enbrel (etanercept), on August 30th. FDA’s decision comes shortly after its...more
In a sign of growing scientific acceptance and understanding of the biosimilar regulatory pathway, FDA’s Arthritis Advisory Committee (AAC) voted unanimously last month in favor of approving two new biosimilar products –...more
Last week, the Centers for Medicare and Medicaid Services (CMS) released its proposed rule for the Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) Payment System for 2017. CMS...more
Earlier this month, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced the release of three YouTube videos and an infographic on individuals’ rights to access health information. In...more