It is being reported that LifeLabs, a Canadian lab company that is the largest provider of laboratory diagnostics and lab testing services in Canada, recently paid an undisclosed ransom to hackers who compromised its computer...more
12/23/2019
/ Biometric Information ,
Clinical Laboratories ,
Connected Cars ,
Connected Items ,
Criminal Conspiracy ,
Cyber Attacks ,
Cybersecurity ,
Data Breach ,
Electronic Medical Records ,
Extradition ,
Hackers ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach ,
Identity Theft ,
Information Technology ,
Malware ,
OCR ,
Personally Identifiable Information ,
PHI ,
Ransomware ,
Settlement
On December 12, 2019, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced its second “HIPAA Right of Access Initiative” settlement of alleged HIPAA violations....more
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
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
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 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
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
On March 6, 2019, the U.S. Department of Health & Human Services Office of Inspector General (OIG) issued a favorable advisory opinion that allows a nonprofit medical center (“Center”) to offer free, in-home follow-up care...more
Since the beginning of 2019, federal and state authorities in Connecticut have announced a number of enforcement actions targeting alleged health care fraud in the state. ...more
On March 26, 2019, the New York Court of Appeals upheld the state Department of Labor’s (the “DOL”) so-called “13-hour rule” governing payment of home health care aides that work 24 hour shifts....more
3/29/2019
/ Department of Labor (DOL) ,
Domestic Workers ,
Employer Liability Issues ,
Health Care Providers ,
Home Health Agencies ,
Home Health Care ,
Home Healthcare Workers ,
Regulatory Requirements ,
Rest and Meal Break ,
State and Local Government ,
State Labor Laws ,
Wage and Hour ,
Work Schedules
On February 25, 2019, the U.S. Department of Justice (DOJ) announced a settlement with a urology group practice to settle allegations of False Claims Act (FCA) violations tied to the alleged submission of improperly unbundled...more
On February 6, 2019, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a proposed rule (Proposed Rule) that would amend the safe harbor regulations under the Federal Anti-Kickback...more
2/7/2019
/ Anti-Kickback Statute ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Rules ,
Rebates ,
Safe Harbors
On December 11, 2018, the U.S. Attorney’s Office for the Eastern District of Pennsylvania (DOJ) announced that it had entered into a $12.5 million dollar settlement with Pennsylvania-based health system Coordinated Health...more
In its 2019 Medicare Physician Fee Schedule Final Rule (PFS Rule), CMS finalized a regulatory change that updates supervision requirements for Registered Radiologist Assistants and Radiology Practitioner Assistants...more
On November 1, 2018, the Centers for Medicare & Medicaid Services (CMS) released its 2019 Physician Fee Schedule Final Rule (PFS Rule), which contains a number of significant substantive changes to Medicare payment practices...more
In late August, the Attorney General of the State of New York announced a $200,000 settlement with a New York-based non-profit organization that provides services to developmentally disabled individuals and their families...more