On June 31, 2024, the Department of Health and Human Services (“HHS”) published a final rule establishing penalties for healthcare providers who violate the information blocking rules implemented under the 21st Century Cures...more
Earlier this year, the Federal Trade Commission (FTC) approved a final rule that invalidates most post-engagement non-compete covenants in all agreements. This rule prohibits use and enforcement of non-compete covenants and...more
8/19/2024
/ Compliance ,
Confidential Information ,
Employer Responsibilities ,
Employment Contract ,
Federal Bans ,
Federal Trade Commission (FTC) ,
Final Rules ,
Health Care Providers ,
Healthcare Workers ,
Non-Compete Agreements ,
Notice Requirements ,
Restrictive Covenants
On October 30, 2023, the Department of Health and Human Services (HHS) released a proposed rule establishing penalties for healthcare providers who violate the information blocking rules implemented under the 21st Century...more
12/28/2023
/ 21st Century Cures Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Electronic Medical Records ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Information Technologies ,
Healthcare ,
Healthcare Reform ,
Information Blocking Rules ,
MIPS ,
OIG ,
Penalties ,
Proposed Rules ,
Regulatory Agenda
Two False Claims Act (“FCA”) cases have recently been decided by the United State Supreme Court, further clarifying one aspect of the FCA. In the recent decisions in U.S. ex rel Proctor v. Safeway, Inc. and U.S. ex rel....more
7/21/2023
/ Drug Pricing ,
False Claims Act (FCA) ,
Healthcare ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Reasonable Interpretations ,
Scienter ,
SCOTUS ,
US ex rel Thomas Proctor v Safeway Inc ,
US ex rel Tracy Schutte et al v SuperValu Inc et al ,
Whistleblowers
On April 12, 2023, the Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced proposed changes to HIPAA’s Privacy Rule with regard to reproductive health information. The proposed changes are set out in a...more
6/6/2023
/ Abortion ,
Department of Health and Human Services (HHS) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Healthcare Reform ,
HIPAA Privacy Rule ,
NPRM ,
OCR ,
Patient Privacy Rights ,
PHI ,
Pregnancy ,
Regulatory Agenda ,
Reproductive Healthcare Issues ,
Roe v Wade ,
Women's Rights
There have been several recent governmental actions which highlight the balance between securing electronic patient information and the need for interoperability and appropriate exchange of such information. This article will...more
HHS Releases Cybersecurity Guide -
On March 8, 2023 the Department of Health and Human Services released a cybersecurity implementation guide for the health care industry—the HPH Sector Cybersecurity Framework...more
The Biden Administration recently announced its intent to end the national emergency and public health emergency declarations on May 11, 2023, over three years since the COVID-19 pandemic began. While there have certainly...more
3/7/2023
/ Biden Administration ,
Coronavirus/COVID-19 ,
Critical Infrastructure Sectors ,
Cybersecurity ,
Emergency Management Plans ,
Health Care Providers ,
Healthcare ,
Infectious Diseases ,
Popular ,
Public Health Emergency ,
Telehealth ,
Telemedicine
Providers oftentimes ask how long they need to retain certain types of medical information. While there are some general rules regarding the timeframes for retaining medical information, the specific answer varies depending...more
10/18/2022
/ Data Retention ,
Document Destruction ,
Electronically Stored Information ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
OCR ,
Personal Information ,
PHI ,
Policies and Procedures ,
Record Retention ,
Regulatory Requirements
Cyber-attacks on health care entities are becoming increasingly frequent, and the resulting data breaches are often complex. In the event of a cyber-attack, health care entities and their business associates must adhere to...more
Getting in to see your doctor is not always as easy as picking up the phone. Often, there is a several-week-long wait for an opening, and the doctor your insurer covered last year may no longer be in-network this year. That...more
OCR Public Comment on Security Practices and Civil Monetary Penalties -
The Office for Civil Rights (“OCR”) is seeking information from stakeholders on two aspects of the Health Information Technology for Economic and...more
HELPFUL HINTS -
The Federal No Surprises Act The Federal No Surprises Act (the “Act”) became fully effective on January 1, 2022. The Act protects enrollees in group and individual market plans (including ERISA plans) and...more
1/25/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Biden v Missouri ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Employer Mandates ,
Healthcare ,
Healthcare Fraud ,
Healthcare Reform ,
Healthcare Workers ,
Infectious Diseases ,
Mental Health ,
National Federation of Independent Business v Department of Labor and OSHA ,
New Legislation ,
OIG ,
OSHA ,
Surprise Medical Bills ,
Vaccinations
Resources -
Safer Federal Workforce Task Force Updates Guidance for Federal Contractors -
On November 10, 2021, the Safer Federal Workforce Task Force updated its Guidance for Federal Contractors (“Guidance”). As...more
11/17/2021
/ Biden Administration ,
Coronavirus/COVID-19 ,
Emergency Management Plans ,
Employer Mandates ,
Equal Employment Opportunity Commission (EEOC) ,
Executive Orders ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
Federal Employees ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Infectious Diseases ,
Marijuana ,
Model Contract Clauses ,
OSHA ,
Public Health Emergency ,
Regulatory Requirements ,
Religious Exemption ,
Vaccinations ,
Workplace Safety
Helpful hints -
OIG Updates Health Care Fraud Self-Disclosure Protocol (“SDP”) -
On November 8, 2021, the OIG issued an updated SDP to providers, which included clarifications of existing guidance and increased the minimum...more
11/16/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Disproportionate Share Adjustments ,
Employer Mandates ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Healthcare Fraud ,
Medicaid ,
Medicare ,
OIG ,
Outpatient Prospective Payment System (OPPS) ,
Physician Fee Schedule ,
Self-Disclosure Requirements ,
Vaccinations
Helpful Hints -
ADPH Says Vaccine Administration is Limited at this Time The Alabama Department of Public Health issued a press release on January 11, 2021, urging Alabamians to have patience in receiving the COVID-19...more
1/29/2021
/ 1135 Waivers ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
Infectious Diseases ,
OCR ,
Right of Access ,
Stark Law ,
Vaccinations
On December 2, 2020, the Centers for Medicare and Medicaid Services (“CMS”) finalized sweeping changes to the federal Physician Self-Referral Law, commonly known as the Stark Law. Many of the changes reflect CMS’ intent to...more
Providers can apply for Phase 3 funds between October 5, 2020 and November 6, 2020.
On October 1, 2020, the Department of Health and Human Services (“HHS”) announced an additional $20 billion in funding for healthcare...more
WHAT MATTERS -
Department of Health and Human Services Office for Civil Rights announces the resolution of two major discrimination complaints against healthcare providers.
Originally Published in the Birmingham Medical...more
The Office for Civil Rights (“OCR”), the entity responsible for HIPAA compliance and enforcement, has issued a series of guidance documents regarding the interplay of HIPAA and the COVID-19 pandemic. The most recent guidance...more
Over the past several months, the Office for Civil Rights (“OCR”), the entity responsible for compliance with and enforcement of the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations...more
The Centers for Medicare & Medicaid Services (CMS) recently issued a 29-page summary of the numerous blanket waivers issued to provide flexibilities to health care providers combating the COVID-19 pandemic....more
Over the past several weeks, the Office for Civil Rights (“OCR”), the entity responsible for compliance with and enforcement of the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations...more
Health care providers operate in one of the most highly regulated industries in terms of compliance and governmental oversight. As a result, providers face a number of regulatory and compliance challenges each year....more
10/25/2019
/ Anti-Kickback Statute ,
Cyber Attacks ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Electronic Medical Records ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
HIPAA Breach ,
PHI ,
Popular ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Standards ,
Rulemaking Process ,
Stark Law
What have you done for me lately? Now that the tune is stuck in your head, specifically, have you recently conducted a thorough and up to date risk assessment in accordance with the requirements of the Health Insurance...more
8/15/2019
/ Cybersecurity ,
Data Privacy ,
Data Protection ,
Electronic Medical Records ,
Failure to Comply ,
Hackers ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach ,
Medical Records ,
OCR ,
PHI ,
Risk Assessment