This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2025, including a new Centers for Medicare & Medicaid Services (CMS) innovation model; proposed rules with significant...more
7/28/2025
/ Affordable Care Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
DMEPOS ,
EMTALA ,
Enforcement Actions ,
Enforcement Priorities ,
False Claims Act (FCA) ,
Healthcare ,
Healthcare Reform ,
Medical Devices ,
OIG
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for October 2024. We discuss several enforcement actions pertaining to healthcare fraud, including alleged violations under the False...more
11/21/2024
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Criminal Convictions ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Fraud ,
Healthcare Reform ,
Legislative Agendas ,
Medicaid ,
Medicare ,
Regulatory Agenda
The US Drug Enforcement Administration (DEA) further extended flexibilities that allow providers to prescribe controlled substances via telemedicine without first performing an in-person visit. The flexibilities were...more
11/19/2024
/ Controlled Substances ,
Coronavirus/COVID-19 ,
DEA ,
Department of Health and Human Services (HHS) ,
Extensions ,
Healthcare ,
Prescription Drugs ,
Public Health Emergency ,
Regulatory Agenda ,
Telehealth ,
Telemedicine ,
Temporary Regulations
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for February 2024. We discuss various regulatory developments, including guidance on the use of AI in coverage decisions and texting...more
3/15/2024
/ Anti-Kickback Statute ,
Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Confidential Information ,
Department of Health and Human Services (HHS) ,
Enforcement ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Healthcare Facilities ,
Healthcare Reform ,
Hospitals ,
Machine Learning ,
Opioid ,
Patient Confidentiality Breaches ,
Substance Abuse ,
Telehealth ,
Texting
On October 18, 2023, the Office for Civil Rights (OCR) of the US Department of Health and Human Services (HHS) issued two resource documents to help explain the privacy and security risks to patients’ protected health...more
10/25/2023
/ Cybersecurity ,
Data Privacy ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
HIPAA Privacy Rule ,
OCR ,
Patient Privacy Rights ,
PHI ,
Telehealth
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for May 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act (FCA)...more
6/23/2023
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Employer Mandates ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Healthcare Reform ,
Medicare ,
Nursing Homes ,
OIG ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Physicians ,
Public Health Emergency ,
Regulatory Agenda ,
Telehealth ,
Telemedicine ,
Vaccinations
On April 20, 2023, the United States Department of Health and Human Services Office of the Inspector General (HHS OIG) released a new toolkit designed to help analyze telehealth claims to assess federal healthcare program...more
The US Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) are extending telehealth flexibilities that allow providers to prescribe controlled substances. While the...more
5/11/2023
/ Controlled Substances ,
Controlled Substances Act ,
DEA ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
OIG ,
Public Health Emergency ,
Rulemaking Process ,
SAMHSA ,
Substance Abuse ,
Telehealth ,
Telemedicine
Digital health is one of the fast-growing segments of the healthcare market, with patients, clinicians and regulators increasingly aligned behind the opportunities that digitization presents.
Over the last three years,...more
3/21/2023
/ Controlled Substances Act ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Digital Health ,
Dobbs v. Jackson Women’s Health Organization ,
Healthcare Fraud ,
Medicare ,
New Legislation ,
New Regulations ,
OIG ,
Proposed Legislation ,
Proposed Regulation ,
Public Health Emergency ,
Roe v Wade ,
State and Local Government ,
State Legislatures ,
Telehealth ,
Telemedicine
In a fourth amendment to the March 17, 2020, Public Readiness and Emergency Preparedness Act (PREP Act), the US Department of Health and Human Services (HHS) has expanded access to COVID-19 Covered Countermeasures through...more
12/9/2020
/ Coronavirus/COVID-19 ,
Countermeasures ,
Department of Health and Human Services (HHS) ,
Fourth Amendment ,
Health Care Providers ,
Immunity ,
Licenses ,
Medical Licensure Compact ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
State and Local Government ,
Telehealth
On March 24, 2020, the US Department of Health and Humans Services Office of Inspector General (OIG) issued guidance regarding OIG’s March 17, 2020, policy statement on reductions or waivers of cost-sharing obligations owed...more
In 2018, even more than in recent years, federal lawmakers and regulators continued the push toward modernizing the existing legal framework to support and encourage digital health adoption in the context of care coordination...more
2/6/2019
/ ACOs ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Corporate Integrity Agreement ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Digital Health ,
Electronic Health Record Incentives ,
Enforcement Actions ,
Health Care Providers ,
Medical Devices ,
Medicare ,
Medicare Advantage ,
OIG ,
Popular ,
Regulatory Reform ,
Request For Information ,
Telehealth ,
Telemedicine
The US Department of Health and Humans Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) have launched the Regulatory Sprint to Coordinated Care, a reform effort that will address several key health care...more
On April 24, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a Health Insurance Portability and Accountability Act of 1996 (HIPAA) settlement in the amount of $2.5 million based on...more
In its tenth OCR Cyber Awareness Newsletter of the year (Newsletter), the Office for Civil Rights (OCR) reminded HIPAA-covered entities and business associates of the importance of selecting an appropriate authentication...more
The US Department of Health and Human Services Office for Civil Rights recently posted guidance clarifying that a business associate such as an information technology vendor generally may not block or terminate access by a...more
10/27/2016
/ Anti-Kickback Statute ,
Business Associates ,
Corporate Counsel ,
Covered Entities ,
Data Blocking ,
Department of Health and Human Services (HHS) ,
EHR ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
OIG ,
PHI ,
Privacy Rule ,
Vendors
On April 27, 2015, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a resolution agreement with Cornell Prescription Pharmacy (CPP) pursuant to which CPP paid a $125,000...more
7/8/2015
/ Change Management ,
Compliance ,
Data Security ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Health Care Providers ,
Health Insurance ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospitals ,
OCR ,
Pharmacies ,
Physicians ,
Policies and Procedures ,
Risk Management ,
Security Risk Assessments
During 2014, the Office for Civil Rights (OCR) of the U.S. Department of Health & Human Services initiated six enforcement actions in response to security breaches reported by entities covered by the Health Insurance...more