National Veterinary Associates (NVA), a large network of veterinary hospitals and clinics, has reportedly been the victim of a ransomware attack. According to the reports, NVA employs more than 2,600 veterinarians, with over...more
12/11/2019
/ Aviation Industry ,
Beneficiaries ,
Biometric Information ,
Bitcoin ,
Cyber Attacks ,
Cyber Crimes ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Drones ,
Hackers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicare ,
Personally Identifiable Information ,
Popular ,
Ransomware ,
Restaurant Industry ,
Settlement Agreements ,
Virtual Currency
On November 27, 2019 the U.S. Department of Health & Human Services Office for Civil Rights (OCR) announced a $2.175 million dollar settlement with a hospital system to resolve alleged violations of HIPAA’s Breach...more
12/4/2019
/ Billing ,
Breach Notification Rule ,
Corrective Actions ,
Data Breach ,
Enforcement Actions ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach ,
HIPAA Privacy Rule ,
Hospitals ,
OCR ,
Personally Identifiable Information ,
PHI ,
Risk Management ,
Settlement
On October 17, 2019, the Centers for Medicare & Medicaid Services (CMS) formally published its proposed rule (the PSR Rule) to update exceptions to the Physician Self-Referral Law (PSR Law, also known as the Stark Law). For...more
10/31/2019
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Commercial Reasonableness ,
Fair Market Value ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Healthcare Reform ,
Patient Referrals ,
Physicians ,
Proposed Rules ,
Rulemaking Process ,
Self-Referral ,
Stark Law ,
Value-Based Care
On October 9, 2019, the Department of Health and Human Services (HHS) released its long-awaited proposals (the Proposed Rules) to update regulatory exceptions to the federal Physician Self-Referral Law (the Stark Law), the...more
On September 4, 2019 the Department of Justice (DOJ) announced a $15.4 million settlement with pharmaceutical company Mallinckrodt ARD LLC (Mallinckrodt) to resolve alleged violations of the Anti-Kickback Statute (AKS) in two...more
9/18/2019
/ Anti-Kickback Statute ,
Co-payments ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud ,
Health Care Providers ,
Marketing ,
Meals-Gifts-and Entertainment Rules ,
Medicare ,
Patient Assistance Programs ,
Pharmaceutical Industry ,
Prescription Drugs ,
Qui Tam ,
Remuneration ,
Settlement Agreements ,
Whistleblowers
In a 3-0 decision issued September 9, 2019, the U.S. Court of Appeals for the Eleventh Circuit affirmed a three-year-old district court ruling in United States v. AseraCare, Inc. that a Medicare claim for hospice services...more
9/17/2019
/ Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraudulent Charges ,
Health Care Providers ,
Healthcare Facilities ,
Hospice ,
Medicare ,
Medicare Beneficiaries ,
Objective Falsity ,
Reversal
The Wolcott school system in Wolcott, Connecticut has been recovering for four months from a ransomware attack that hit its system at the end of the school year. Last week, it was hit with a second attack. According to...more
9/13/2019
/ Consumer Privacy Rights ,
Cyber Attacks ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Debt Collectors ,
Digital Assets ,
Educational Institutions ,
Enforcement Actions ,
Financial Services Industry ,
Hackers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Medical Records ,
Municipalities ,
NIST ,
Personally Identifiable Information ,
Ransomware ,
TCPA
On September 9, 2019, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that it had settled its first ever HIPAA enforcement action arising from alleged violations of the individual...more
9/11/2019
/ Corrective Actions ,
Data Management ,
Electronic Medical Records ,
Enforcement Actions ,
Failure to Comply ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach ,
OCR ,
Personally Identifiable Information ,
PHI ,
Regulatory Standards ,
Regulatory Violations ,
Right of Access
On September 9, 2019, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that it had settled its first ever HIPAA enforcement action arising from alleged violations of the individual...more
On August 26, 2019, the Department of Health and Human Services Substance Abuse and Mental Health Services Administration (SAMHSA) published a notice of proposed rulemaking (NPRM) to “better align” its substance use disorder...more
9/4/2019
/ Comment Period ,
Confidentiality Policies ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Medical Monitoring ,
NPRM ,
Opioid ,
Pain Management ,
Patients ,
Prescription Drugs ,
Public Comment ,
Regulatory Oversight ,
Regulatory Requirements ,
Rulemaking Process ,
SAMHSA ,
Substance Abuse
The Massachusetts Board of Registration in Medicine (BORM) recently approved significant changes to regulations governing the licensure and practice of medicine. The new regulations became effective on August 9, 2019. ...more
In a complaint filed on July 22, 2019, the U.S. Attorney’s Office for the Southern District of New York (DOJ) intervened in a qui tam False Claims Act (FCA) suit against Life Spine Inc. (Life Spine), and senior executives of...more
On July 15, 2019, Rhode Island Governor Gina Raimondo signed into law “An Act Relating To Businesses and Professions – Physician Assistants” (H5572/S0443), which significantly revises the supervision requirements and expands...more
7/19/2019
/ Deregulation ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Reform ,
Hospitals ,
New Legislation ,
Physician Assistants ,
Policies and Procedures ,
Scope of Work ,
State and Local Government ,
Supervision
On June 13, 2019, the U.S. Court of Appeals for the Eighth Circuit affirmed a preliminary injunction granted to the Federal Trade Commission (FTC) and North Dakota Attorney General (NDAG) blocking the proposed acquisition of...more
7/1/2019
/ Anti-Competitive ,
Antitrust Provisions ,
Appeals ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Health Clinics ,
Physicians ,
Preliminary Injunctions ,
State Attorneys General ,
The Clayton Act
On June 5, 2019, the Department of Justice (DOJ) announced a global settlement with Insys Therapeutics (Insys) that preliminarily resolves criminal and civil cases against the opioid manufacturer in a number of jurisdictions....more
6/26/2019
/ Chapter 11 ,
Commercial Bankruptcy ,
Criminal Investigations ,
Department of Justice (DOJ) ,
Drug & Alcohol Abuse ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Kickbacks ,
Mail Fraud ,
Manufacturers ,
Marketing ,
Opioid ,
Pain Management ,
Pharmaceutical Industry ,
Prescription Drugs ,
Settlement Agreements
Vicious malware continues to be deployed by China-based attackers. A new strain of malware, dubbed “HiddenWasp,” which has the ability to remotely infect computers, has been discovered by a security researcher at Intezar. The...more
6/7/2019
/ California Consumer Privacy Act (CCPA) ,
China ,
Cyber Attacks ,
Cybersecurity ,
Data Breach ,
Data Protection ,
Exploitation ,
Extortion ,
FBI ,
Genetic Materials ,
Genetic Testing ,
Hackers ,
Information Technology ,
Malware ,
OIG ,
Online Safety for Children ,
Personal Data ,
Personally Identifiable Information ,
Popular ,
Quest Diagnostics ,
Vulnerable Victims
In a 7-1 decision released June 3, 2019, the U.S. Supreme Court vacated a proposal of the U.S. Department of Health and Human Services (HHS) that would have had the effect of significantly reducing Disproportionate Share...more
6/6/2019
/ Administrative Procedure Act ,
Azar v Allina Health Services ,
Department of Health and Human Services (HHS) ,
Hospitals ,
Low-Income Issues ,
Medicare ,
Medicare Advantage ,
Medicare Part A ,
Medicare Part C ,
Notice and Comment ,
Pay Reductions ,
Provider Payments ,
Reaffirmation ,
Retroactive Application ,
SCOTUS ,
Substantive Rule ,
Vacated
On June 3, 2019, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a fraud alert to notify consumers about genetic testing fraud schemes (the Alert)....more
Although many thought that WannaCry was in the rear view mirror, a recent report by Artemis, based on client experience, found that health care organizations and manufacturing companies are still being hit with the ransomware...more
5/31/2019
/ Cyber Crimes ,
Cyber Insurance ,
Cybersecurity ,
Data Privacy ,
Enforcement Actions ,
Hackers ,
Health Care Providers ,
HIPAA Breach ,
Malware ,
Manufacturers ,
OCR ,
Personally Identifiable Information ,
Ransomware ,
Robocalling ,
Telemarketing
In a development that may – understandably – have been overlooked by many heading into Memorial Day weekend, on May 24, 2019, the Health and Human Service’s (HHS) Office for Civil Rights (OCR) issued a Fact Sheet on Direct...more
On May 7, 2019, the U.S. Department of Justice (DOJ) provided important new guidance addressing cooperation credit that may be available to defendants in False Claims Act (FCA) investigations (Guidance)....more
On April 30, 2019, the Office of the Attorney General of Massachusetts (AG) announced that it had entered into two settlements totaling over $10 million with home health care companies to resolve allegations of submission of...more
According to a recent survey of cybersecurity professionals by AT&T Cybersecurity entitled “Confidence: the perception and reality of cybersecurity threats,” phishing and cloud security threats are keeping them up at...more
5/3/2019
/ Best Practices ,
Cyber Attacks ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
Drones ,
Federal Aviation Administration (FAA) ,
Hackers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HITECH Act ,
Limitation of Liability Clause ,
Phishing Scams ,
Popular ,
Unmanned Aircraft Systems
On April 26, 2019, the U.S. Department of Health and Human Services (HHS) issued a Notification of Enforcement Discretion (Notice) regarding imposition of Civil Money Penalties (CMPs) under HIPAA. ...more
4/30/2019
/ Civil Monetary Penalty ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Electronic Medical Records ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach ,
HITECH Act ,
Personally Identifiable Information ,
PHI ,
Security Standards
According to Hiscox’s Third Cyber Readiness Report, which surveyed 5,400 firms in the U.S. and the E.U., cyber threats have “become the unavoidable cost of doing business today.” The Report notes that for the first time, “a...more
4/29/2019
/ Charitable Donations ,
Cyber Attacks ,
Cybersecurity ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Hackers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
Personally Identifiable Information ,
Popular ,
Scams ,
Vulnerability Assessments