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
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
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
The Department of Homeland Security (DHS) issued a warning on April 15, 2019 entitled “VPN Applications Insecurely Store Session Cookies” (Vulnerability Note VU#192371) stating that “[M]ultiple Virtual Private Network (VPN)...more
4/19/2019
/ Cookies ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Email ,
Hackers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Incident Response Plans ,
Information Technology ,
Personally Identifiable Information ,
Phishing Scams
On April 8, 2019, The University of Texas MD Anderson Cancer Center (MDA) filed a petition with the U.S. Court of Appeals for the Fifth Circuit seeking review of a decision by the Department of Health & Human Services’s (HHS)...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
The Office of Inspector General (OIG) recently announced the creation of a cybersecurity team focused on combating threats within the Department of Health & Human Services (HHS), and within the health care industry. ...more
On September 17, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services published a favorable Advisory Opinion allowing a manufacturer of surgical devices and wound care products to offer a...more
9/20/2018
/ Advisory Opinions ,
Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Hospitals ,
Manufacturers ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
Product Defects ,
Warranties ,
Written Agreements
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 May 24, 2016, the Department of Health & Human Services (HHS) issued guidance (Guidance) to health care providers and patient safety organizations (PSOs) in an attempt to clarify the definition of patient safety work...more
The U.S. Department of Health & Human Services (HHS) Office of Inspector General (OIG) recently released a compendium (Compendium) of its top unimplemented recommendations. The Compendium comprises 25 unimplemented past OIG...more
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 January 23, 2015, the United States Department of Labor (DOL) filed a notice of appeal with the United States Court of Appeals for the District of Columbia (District Court) challenging two rulings in the case of Home Care...more
2/23/2015
/ Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Fair Labor Standards Act (FLSA) ,
Fee-for-Service ,
Final Rules ,
Healthcare ,
Home Health Agencies ,
Home Health Care ,
Home Healthcare Workers ,
Meaningful Use ,
Medicare ,
Quality of Care Standards ,
Wage and Hour
Earlier this year, Connecticut enacted P.A. 14 - 168, which requires hospitals, hospital systems, and physician group practices composed of 30 or more physicians to report to the attorney general and the Department of Public...more
In This Issue:
- OIG Releases Proposed Rule Revising the Anti-Kickback Statute Safe Harbors and Civil Monetary Penalty Rules
..AKS Safe Harbors
..Revisions to the Civil Monetary Penalty...more