The United States Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) have further extended flexibilities that allow providers to prescribe controlled substances...more
10/9/2023
/ Controlled Substances ,
Coronavirus/COVID-19 ,
DEA ,
Extensions ,
Healthcare ,
Prescription Drugs ,
Public Health Emergency ,
SAMHSA ,
Telehealth ,
Telemedicine ,
Temporary Regulations
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
Trending in Telehealth is a series from the McDermott digital health team in which we highlight state legislative and regulatory developments that impact healthcare providers, telehealth and digital health companies,...more
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
On February 24, 2023, the US Drug Enforcement Administration (DEA) issued two proposed rules (the Telemedicine Controlled Substance Proposed Rule and the Telemedicine Buprenorphine Proposed Rule) that would establish...more
On December 23, 2022, US Congress approved a year-end omnibus legislative package, Consolidated Appropriations Act, 2023 (CAA 2023), which consists of all 12 fiscal year 2023 appropriations bills and numerous other...more
Telehealth has become an integral part of care delivery, particularly in light of the waivers instituted during COVID-19. However, these flexibilities remain in flux and at the same time, government scrutiny and enforcement...more
4/19/2021
/ Compliance ,
Continuing Legal Education ,
Coronavirus/COVID-19 ,
Criminal Prosecution ,
Enforcement Actions ,
Health Care Providers ,
Health Technology ,
Healthcare Facilities ,
Hospitals ,
Patients ,
Physicians ,
Public Health Emergency ,
Regulatory Oversight ,
Risk Mitigation ,
Telehealth ,
Telemedicine ,
Waivers ,
Webinars
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
The US Drug Enforcement Administration (DEA) stated in an FAQ on its website that prescribers may issue prescriptions for controlled substances based on a telemedicine encounter in the absence of an in-person medical...more