On April 26, 2024, the Federal Trade Commission (“FTC”) announced it had finalized changes to modernize the Health Breach Notification Rule (the “HBNR”) by clarifying its applicability to health and wellness apps and other...more
5/7/2024
/ Breach Notification Rule ,
Data Breach ,
Data Privacy ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Federal Trade Commission (FTC) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Personally Identifiable Information ,
PHI ,
Popular
On April 18, 2024, the Federal Trade Commission (“FTC”), Justice Department (“DOJ”), and the U.S. Department of Health and Human Services (“HHS”) launched an online reporting portal, HealthyCompetition.gov, for the public to...more
Seyfarth Synopsis: The health care sector faces escalating cybersecurity risks given its size, technological dependence and the sensitive nature of data used therein. According to the U.S. Department of Health and Human...more
1/23/2024
/ Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Security ,
Data Theft ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Employer Liability Issues ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Information Technology ,
OCR ,
PHI ,
Policies and Procedures ,
Popular
On March 12, 2021, the US Department of Health and Human Services (“HHS”) amended, its Declaration under the Public Readiness and Emergency Preparedness Act (“PREP Act”) for the seventh time. The Seventh Amendment expands the...more
On January 28, 2021, the U.S. Department of Health and Human Services (“HHS”) issued a Fifth Amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (“PREP Act”), which expands the categories of...more
The US Department of Health and Human Services (“HHS”) issued an Advisory Opinion (“21-01”) Friday, reinforcing how the Public Readiness and Emergency Preparedness Act (“PREP Act” or the “Act”) (1) provides complete...more
On December 3, 2020, the U.S. Department of Health and Human Services (HHS) issued another groundbreaking amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act). ...more
12/8/2020
/ Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Diagnostic Tests ,
Health Care Providers ,
Immunity ,
Infectious Diseases ,
Liability ,
Medical Supplies ,
Personal Protective Equipment ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Telehealth
As mentioned in our earlier report, on November 20, 2020, The Department of Health and Human Services (HHS) Office of Inspector General (OIG) and Centers for Medicare & Medicaid Services (CMS) published two long-awaited final...more
Earlier last Friday, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) of U.S. Department of Health and Human Services (HHS) announced their new, long-awaited rule changes to the...more
The U.S. Department of Health and Human Services (HHS) recently issued two new advisory opinions dramatically illuminating the wide scope of the PREP Act and its immunities for organizations using covered countermeasures in...more
Health care providers looking for long-awaited answers to new proposed rules changes governing physician self-referral arrangements may have to wait a bit longer. ...more
9/10/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Electronic Health Record Incentives ,
Final Rules ,
Health Care Providers ,
OIG ,
Physicians ,
Rulemaking Process ,
Self-Referral ,
Stark Law
To assist in the response of the nation’s health care providers to the COVID-19 pandemic, on August 24, 2020, the Secretary for the U.S. Department of Health and Human Services (HHS) issued a Third Amendment to his March 10,...more
On June 4, 2020, the Secretary for the US Department of Health and Human Services (HHS) issued a Notice of Amendment (Amendment) to his March 10, 2020 Declaration that had applied the federal immunities of the Public...more
The US Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) recently announced its “Strategic Plan: Oversight of COVID-19 Response and Recovery,” a document that sets forth OIG top goals and...more
On May 19, 2020, the US Department of Health and Human Services (HHS) Office of General Counsel (OGC) issued an advisory opinion (Advisory Opinion) finding that the Public Readiness and Emergency Preparedness Act1(PREP Act)...more
To enhance regulatory flexibility necessary to adequately respond to the COVID-19 pandemic, the US Department of Health and Human Services (HHS) Office of the Inspector General (OIG) recently announced that it is accepting...more
On April 27, 2020, the US Supreme Court ruled by an 8-1 decision that the federal government must pay billions of dollars to health insurers who sold consumer policies on exchanges under the Affordable Care Act’s (“ACA”)...more
4/28/2020
/ Affordable Care Act ,
Appropriations Bill ,
CARES Act ,
Corporate Counsel ,
Court of Federal Claims ,
Damages ,
Department of Health and Human Services (HHS) ,
Financial Obligations ,
Government Payments ,
Health Insurance ,
Insurance Industry ,
Reimbursements ,
Remand ,
Repeal ,
Reversal ,
Risk Corridors Statute ,
SCOTUS
To assist hospitals in credentialing physicians during the COVID-19 pandemic, the National Practitioner Data Bank (“NDPB”)—the federal clearinghouse for adverse action reports against physicians—has announced it is waiving...more
4/20/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Eligibility ,
Enrollment ,
Fee Waivers ,
Fees ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Hospitals ,
Medicaid ,
Medicare ,
National Practitioner Data Bank (NPDB) ,
Physicians
With crisis comes uncertainty, and even the best-intentioned regulations can leave those combating the current COVID-19 public-health emergency out in the cold. Many have asked whether the recent Declaration under the...more
4/15/2020
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Eligibility ,
Emergency Response ,
Enrollment ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Hospitals ,
Medicaid ,
Medicaid Expansion ,
Medicare ,
OIG ,
Public Health ,
Regulatory Agencies ,
State and Local Government
A critical aspect of the response to the COVID-19 public-health crisis in the United States is the rapid expansion of testing capabilities across the country. Given that almost all Americans live in close proximity to retail...more
As follow-up to our overview “Emergency Childcare: A Guide for Health Care Providers,” below is a deeper dive on some state-specific considerations. There are some impactful measures that some states have already taken which...more
In an effort to modernize and clarify a statute that looms large in the minds of health care providers across the nation, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) recently...more
11/22/2019
/ ACOs ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Electronic Medical Records ,
Health Care Providers ,
Healthcare Reform ,
Incentives ,
OIG ,
Physicians ,
Proposed Rules ,
Regulatory Requirements ,
Rulemaking Process ,
Safe Harbors ,
Stark Law ,
Telehealth ,
Value-Based Care
As part of a larger “Regulatory Sprint to Coordinated Care” the Centers for Medicare & Medicaid Services (CMS) of the U.S. Department of Health & Human Services (HHS) recently issued a proposed rule aimed at modernizing and...more
11/18/2019
/ Arms Length Transactions ,
Centers for Medicare & Medicaid Services (CMS) ,
Commercial Reasonableness ,
Department of Health and Human Services (HHS) ,
Equipment Rentals ,
Fair Market Value ,
Health Care Providers ,
New Guidance ,
Office Space ,
OIG ,
Physicians ,
Proposed Amendments ,
Public Comment ,
Self-Referral Disclosure Protocol ,
Stark Law ,
Suppliers