Amidst the cavalcade of regulatory and policy changes from federal and state governments intended to help health care providers confront the COVID-19 pandemic, on April 21, 2020 the Centers for Medicare & Medicaid Services...more
5/6/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Physicians ,
Self-Referral ,
Stark Law ,
Waivers
Connecticut Governor Ned Lamont recently issued four new executive orders to address the COVID-19 state of emergency (Executive Orders 7CC – 7FF) that contain provisions relevant to health care providers and facilities in the...more
On April 9, 2020 the Department of Health & Human Services Office for Civil Rights (OCR) issued another Notification that it will exercise its enforcement discretion and not impose penalties for HIPAA violations in connection...more
Governor Lamont issued two new executive orders designed to expand the health care workforce, immunize providers from COVID-19-related liability, and protect patients from out-of-network bills for COVID-19 treatment. On April...more
On March 30th, the Centers for Medicare and Medicaid Services (CMS) issued blanket waivers (Blanket Waivers) of sanctions under the federal physician self-referral law (Stark Law) to relax regulatory requirements related to...more
The Connecticut Department of Consumer Protection Drug Control Division (DCP) has issued guidance for health care providers regarding refills and reissuances of controlled substance prescriptions for patients without an...more
The Connecticut Office of Health Strategy (OHS) issued its third guidance document related to CON requirements related to the COVID-19 pandemic on March 25, in which OHS waives CON approval requirements for hospitals seeking...more
On March 27, Congress enacted the Coronavirus Aid, Relief, and Economic Security Act (CARES Act, or the Act), Public Law 116-136, a trillion-dollar stimulus bill intended to provide financial assistance to individuals and...more
On March 24, 2020, the U.S. Department of Health & Human Services (HHS) Office for Civil Rights (OCR) issued new HIPAA guidance to help providers and first responders in efforts to combat the COVID-19 pandemic....more
On March 20, the Connecticut Office of Health Strategy (OHS) issued new guidance (Guidance) on the process for requesting a certificate of need (CON) waiver for projects related to the COVID-19 response. See our analysis of...more
On March 19, Connecticut Governor Ned Lamont issued Executive Order No. 7G, which is intended to expand access to telehealth services for Connecticut residents amidst the COVID-19 pandemic....more
As part of Executive Order No. 7F issued on March 18, Connecticut Governor Ned Lamont authorized the Commissioner of the Department Social Services (DSS) to “temporarily waive any requirements” set forth in state law,...more
On March 17 the Trump Administration announced expanded reimbursement for clinicians providing telehealth services for Medicare beneficiaries during the COVID-19 Public Health Emergency. The Centers for Medicare and Medicaid...more
3/19/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Emergency Management Plans ,
Health Care Providers ,
Medicaid ,
Medical Reimbursement ,
Medicare ,
OIG ,
Public Health ,
Relief Measures ,
Telehealth ,
Telemedicine ,
Trump Administration
On March 16, Connecticut agencies released two important guidance documents for state health care providers and organizations confronting the COVID-19 pandemic...more
3/18/2020
/ Certificate of Need ,
China ,
Coronavirus/COVID-19 ,
Deregulation ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Infectious Diseases ,
Public Health ,
Relief Measures ,
Reviewability Determinations ,
State and Local Government
Following the President’s proclamation on March 13 that the COVID-19 outbreak constitutes a national emergency, Secretary of the Department of Health and Human Services (HHS) Alex Azar issued a Waiver or Modification of...more
3/17/2020
/ Acute Facilities ,
Centers for Medicare & Medicaid Services (CMS) ,
China ,
Coronavirus/COVID-19 ,
Crisis Management ,
Department of Health and Human Services (HHS) ,
Emergency Management Plans ,
Health Care Providers ,
HIPAA Privacy Rule ,
Infectious Diseases ,
Public Health ,
Relief Measures ,
Secretary of HHS ,
Skilled Nursing Facility ,
Social Security Act ,
Waivers
Over the weekend, Connecticut Governor Ned Lamont issued a new Executive Order 7C, which has significant implications for facilities in Connecticut that provide mental health treatment amidst the COVID-19 outbreak....more
3/17/2020
/ China ,
Confidential Communications ,
Coronavirus/COVID-19 ,
Crisis Management ,
Emergency Management Plans ,
Executive Orders ,
Health Care Providers ,
Healthcare Facilities ,
Infectious Diseases ,
Mental Health ,
Public Health ,
State and Local Government
On February 27, 2020, the Federal Trade Commission (FTC) announced an action to block a proposed transaction between Thomas Jefferson University d/b/a Jefferson Health (Jefferson) and Albert Einstein Healthcare Network...more
3/6/2020
/ Anti-Competitive ,
Antitrust Provisions ,
Antitrust Violations ,
Competition ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
FTC Act ,
Health Care Providers ,
Horizontal Mergers ,
Hospital Mergers ,
Hospitals ,
Merger Agreements
On January 27, 2020, the Department of Justice (DOJ) announced a $145 million settlement with Practice Fusion Inc., an electronic health records (EHR) software company, that resolves parallel criminal and civil investigations...more
1/31/2020
/ Anti-Kickback Statute ,
Criminal Prosecution ,
Deferred Prosecution Agreements ,
Department of Justice (DOJ) ,
EHR ,
Electronic Medical Records ,
Enforcement Actions ,
Failure to Comply ,
False Claims Act (FCA) ,
Fines ,
Forfeiture ,
Health Care Providers ,
Opioid ,
Patients ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs
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