We have previously reported on the ongoing cybersecurity issues with St. Jude defibrillators [view related posts here, here, and here]. On June 29, 2018, the Food and Drug Administration (FDA) classified the required firmware...more
7/16/2018
/ Adidas ,
Computer Fraud and Abuse Act (CFAA) ,
Constitutional Challenges ,
Cyber Attacks ,
Cybersecurity ,
Data Breach ,
Drones ,
Emergency Management Plans ,
Emergency Response ,
EU-US Privacy Shield ,
Federal Aviation Administration (FAA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Hackers ,
Healthcare ,
Healthcare Facilities ,
HIPAA Breach ,
Medical Devices ,
Mobile Apps ,
Popular ,
Ransomware ,
Regulatory Requirements ,
Regulatory Violations ,
St Jude Medical Center ,
Wildfires
On July 9, 2018, Cass Regional Medical Center (CRMC) in Harrisonville, Missouri was hit with a ransomware attack that led to a complete shutdown of its electronic health record (EHR) and the diversion of trauma and stroke...more
“Orangeworm” Targeting Health Care Industry -
In what is being called a systematic targeting of large health care organizations, pharmaceutical companies, and IT companies and equipment manufacturers that service the...more
4/27/2018
/ Blue Shield ,
Criminal Investigations ,
Cyber Attacks ,
Cyber Insurance ,
Data Breach ,
Digital Currency ,
Drones ,
Enforcement Actions ,
Extraterritoriality Rules ,
Hackers ,
Health Care Providers ,
Healthcare ,
Medical Devices ,
Personal Data ,
PHI ,
Risk Management ,
Scams ,
September 11th Victim Compensation Fund ,
SunTrust ,
Unmanned Aircraft Systems ,
US v Microsoft ,
Virtual Currency
On February 13, 2018, the HHS Office for Civil Rights (OCR) announced a $100,000 settlement with a court-appointed receiver representing Filefax, Inc. (Filefax) arising from the 2015 discovery of medical records that...more
The Office of Inspector General (OIG) recently issued a favorable advisory opinion (Advisory Opinion) to a university health system (Requestor) regarding two arrangements: (1) a proposal to waive cost-sharing obligations of...more
On December 7, 2016, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited final rule (Final Rule) that expands the safe harbor regulations under the Anti-Kickback Statute (AKS)...more
12/20/2016
/ Ambulance Providers ,
Anti-Kickback Statute ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Healthcare ,
Medicaid ,
Medicare ,
OIG ,
Remuneration ,
Rural Areas ,
Safe Harbors
On November 30, 2016, the U.S. House of Representatives voted strongly in favor of the 21st Century Cures Act (the Act), an expansive health bill that addresses the discovery and development of new medical therapies as well...more
12/6/2016
/ Disclosure ,
Electronic Medical Records ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Mental Health ,
OIG ,
Pending Legislation ,
PHI ,
Privacy Rule ,
Substance Abuse
On October 14, 2016, the Centers for Medicare and Medicaid Services (CMS) released a final rule with comment period (Final Rule) implementing the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The Final Rule...more
10/28/2016
/ Alternative Payment Models (APM) ,
CEHRT ,
Centers for Medicare & Medicaid Services (CMS) ,
Health Care Providers ,
Healthcare ,
Medicare ,
Medicare Access and CHIP Reauthorization (MACRA) ,
MIPS ,
Physician Medicare Reimbursements ,
Physicians ,
PQRS ,
Quality Payment Program (QPP) ,
Rural Health Care Providers ,
Value-Based Payments
On September 27, 2016, the U.S. Court of Appeals for the Third Circuit handed the Federal Trade Commission (FTC) a significant antitrust victory by granting its request for a preliminary injunction to stay the pending merger...more
DOJ, NY AG REACH SETTLEMENT WITH HOSPITALS IN LANDMARK 60 - DAY RULE CASE -
On August 24, 2016, the U.S. attorney for the Southern District of New York and the New York State attorney general announced a $2.95 million...more
9/7/2016
/ 60-Day Rule ,
Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Medicare Part A ,
Medicare Part B ,
Overpayment ,
Overpayment Recovery Time Limits ,
Physician Assistants ,
Settlement ,
Vaccinations
The Centers for Medicare & Medicaid Services (CMS) recently issued a final rule (Final Rule) that implements the Comprehensive Care for Joint Replacement model (CJR Model), a new bundled payment program covering certain...more
On January 7, 2015, HHS issued new guidance (Guidance) regarding an individual’s right to access his or her health information under HIPAA’s Privacy Rule. The Guidance emphasizes that HIPAA, while protecting the privacy and...more
CHANGES TO STARK LAW, NEW ADVANCE CARE PAYMENTS INCLUDED IN 2016 PHYSICIAN
FEE SCHEDULE -
The Centers for Medicare & Medicaid Services (CMS) recently published a final rule (Final Rule) regarding physician payment...more
On October 29, 2015, the Centers for Medicare & Medicaid Services and the Office of Inspector General of the Department of Health & Human Services (jointly, the “Agencies”) issued a final rule (Final Rule) regarding waivers...more
On October 16, 2015, the Centers for Medicare & Medicaid Services (CMS) published a final rule (Final Rule) that streamlines Stage 2 and finalizes Stage 3 of the Medicare and Medicaid electronichealth record (EHR) Incentive...more
11/4/2015
/ CEHRT ,
Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
EHR ,
Electronic Health Record Incentives ,
Final Rules ,
Health Care Providers ,
Healthcare ,
Meaningful Use ,
Medicaid ,
Medicare ,
Reporting Requirements
On September 29, it was revealed that the HHS Office for Civil Rights (OCR) will commence Phase 2 of its HIPAA audit program in “early 2016.” OCR’s revelation regarding the Phase 2 audits, which had been the subject of...more
10/9/2015
/ Audits ,
Compliance ,
Cyber Attacks ,
Cyber Crimes ,
Cybersecurity ,
Data Breach ,
Data Security ,
Department of Health and Human Services (HHS) ,
Hackers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HITECH Act ,
OCR ,
OIG ,
Privacy Rule ,
Regulatory Oversight Committee
On September 2, 2015, the U.S. Department of Health & Human Services (HHS) announced that Cancer Care Group, P.C. (CCG), a physician practice located in Indiana, agreed to pay $750,000 as part of a settlement to resolve...more
9/17/2015
/ Compliance ,
Corrective Actions ,
Cybersecurity ,
Data Breach ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
Electronic Medical Records ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
OCR ,
Personally Identifiable Information ,
PHI ,
Privacy Rule ,
Settlement Agreements
The U.S. Department of Justice (DOJ) recently announced that KMART Corp. (Kmart) has paid $1.4 million to settle a qui tam lawsuit brought by a former Kmart pharmacist under the False Claims Act (FCA). The lawsuit alleged...more
9/9/2015
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Generic Drugs ,
Healthcare ,
HEAT ,
Kickbacks ,
Kmart ,
Medicare ,
Pharmacies ,
Prescription Drugs
On August 21, 2015, the United States Court of Appeals for the District of Columbia Circuit (DC Circuit) reinstated Department of Labor (DOL) regulations that require home care agencies and other third-party employers of...more
On August 3, 2015, the United States District Court in the Southern District of New York issued a long-awaited opinion and order rejecting a motion to dismiss filed by the defendants in U.S. ex rel. Kane v. Continuum Health...more
8/21/2015
/ 60-Day Rule ,
Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Medicaid ,
Medicare ,
Medicare Part A ,
Medicare Part B ,
Overpayment ,
Overpayment Recovery Time Limits ,
Whistleblowers
The Office of the Inspector General (OIG) recently issued a favorable advisory opinion (Advisory Opinion) to a nonprofit health system (System) and a nonprofit psychiatric hospital (Center) regarding a proposal whereby the...more
8/18/2015
/ Advance Directives ,
Affordable Care Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Employees ,
Fair Market Value ,
FQHC ,
Health Care Providers ,
Healthcare ,
Medicaid ,
Medicare ,
Non-Profit Hospitals ,
OIG ,
Physician Fee Schedule ,
Physicians ,
Rural Health Care Providers ,
Stark Law ,
Timeshare
On June 29 and 30, 2015, the Connecticut General Assembly conducted a special legislative session following the close of the 2015 regular session. Among other things, the General Assembly passed a bill to implement the state...more
8/13/2015
/ Audits ,
Certificate of Need ,
DSS ,
FQHC ,
Health Care Providers ,
Healthcare ,
HIV ,
Home Healthcare Workers ,
Hospitals ,
Medicaid ,
Medicaid Reimbursements ,
Medical Reimbursement ,
Municipalities ,
Nurses ,
Nursing Homes ,
Pay-for-Performance ,
Personal Property ,
Prescription Drugs ,
Property Tax ,
Public Health ,
Reporting Requirements ,
Screening Procedures ,
Tax Rates
On July 10, the U.S. House of Representatives approved the 21st Century Cures Act (the Act), a bill intended to support advancements in medical innovation. The Act includes measures aimed at spurring medical research,...more
Effective October 1, 2015, this legislation contains several provisions to encourage the free exchange of patient health information among providers and consumers. Hospitals, health systems, and electronic health record (EHR)...more
Effective October 1, 2015, this legislation requires the Connecticut Health Insurance Exchange (HIX) to establish, by July 1, 2016, a consumer health information website that contains information comparing the quality, price,...more