Since the declaration of the public health emergency due to the COVID-19 epidemic, Drug Enforcement Administration (DEA) registered practitioners have been able to prescribe controlled substances, without a prior in-person...more
5/19/2023
/ Comment Period ,
Controlled Substances ,
Controlled Substances Act ,
Coronavirus/COVID-19 ,
DEA ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
NPRM ,
Pharmacies ,
Prescription Drugs ,
Public Health Emergency ,
SAMHSA ,
Telehealth ,
Telemedicine
The Controlled Substances Act, as amended by the Ryan Haight Act, generally prohibits prescribing controlled substances via telehealth without a prior in-person examination, subject to certain very limited exceptions. Those...more
Less than one month after the Biden administration’s announcement on January 20, 2023, declaring the end of the public health emergency (PHE) on May 11, 2023, the US Drug Enforcement Administration (DEA) has announced...more
3/24/2023
/ Comment Period ,
Controlled Substances ,
Controlled Substances Act ,
Coronavirus/COVID-19 ,
DEA ,
Health Care Providers ,
Prescription Drugs ,
Public Health Emergency ,
Ryan Haight Act ,
Telehealth ,
Telemedicine
During the COVID-19 pandemic, telehealth utilization exploded. Globally, the telehealth market is valued at $83.5 billion and is expected to grow by 24% between 2023 and 2030. As services delivered via telehealth became more...more
2/7/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Controlled Substances ,
Coronavirus/COVID-19 ,
DEA ,
Health Care Providers ,
Prescription Drugs ,
Public Health Emergency ,
Relief Measures ,
State and Local Government ,
Telehealth ,
Telemedicine ,
Waivers
Providers and platforms should know that healthcare in the metaverse — which may involve telepresence, digital twinning, and blockchain — is subject to ‘real life’ regulations.
The metaverse uses technologies such as...more
1/27/2023
/ Artificial Intelligence ,
Blockchain ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Corporate Practice of Medicine ,
Digital Health ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Health Technology ,
Licensing Rules ,
Life Sciences ,
Metaverse ,
Popular ,
Regulatory Requirements ,
Regulatory Standards ,
Telehealth ,
Telemedicine ,
Virtual Reality
The off-label use of ketamine to treat anxiety, depression, and other behavioral health disorders —coupled with the COVID-19 telehealth era—has spurred the opening of virtual ketamine clinics nationwide. Some clinics offer a...more
11/17/2022
/ Controlled Substances Act ,
Corporate Practice of Medicine ,
DEA ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Clinics ,
Informed Consent ,
Licensing Rules ,
Mental Health ,
Mental Illness ,
Prescription Drugs ,
Public Health Emergency ,
Regulatory Requirements ,
Telehealth
On March 15, 2022, President Biden signed into law the $1.5 trillion Consolidated Appropriations Act of 2022 (the “Omnibus Bill”). Included in the 2,700+ page Omnibus Bill is an extension of Medicare coverage of professional...more
The U.S. Department of Justice (“DOJ”) recently announced that over $5.6 billion in False Claims Act (“FCA”) settlements and judgments had been reached during the 2021 fiscal year, with over $5 billion of those settlements...more
3/8/2022
/ Anti-Kickback Statute ,
Clinical Laboratories ,
Department of Justice (DOJ) ,
Digital Health ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Technology ,
Healthcare Fraud ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Private Equity ,
Telehealth
The COVID-19 Public Health Emergency (“PHE”) fundamentally changed the healthcare industry, forcing healthcare providers and patients onto their computers and phones to enable continuation of care when patients were mandated...more
2/23/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Digital Health ,
Health Care Providers ,
Medicare ,
Medicare Beneficiaries ,
Mental Health ,
Physicians ,
Public Health Emergency ,
Reimbursements ,
Telehealth ,
Telemedicine
Telehealth’s exponential growth –in part due to the COVID-19 pandemic – has highlighted both its value in increasing access to care and the potential for misuse. The U.S. Department of Health and Human Services’ Office of...more
The use of telehealth continues to grow rapidly across the U.S. Given legislative proposals and the Centers for Medicare & Medicaid Services efforts to expand access to telehealth, we can only anticipate that remotely...more
9/13/2021
/ Artificial Intelligence ,
Business Associates ,
Business Associates Agreement (BAA) ,
Corporate Practice of Medicine ,
Data Privacy ,
Data Protection ,
Data Security ,
Disparate Impact ,
Electronic Protected Health Information (ePHI) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Machine Learning ,
Medical Malpractice ,
PHI ,
Physicians ,
Professional Liability ,
Telehealth