DTC Telehealth Platforms -
Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more
1/31/2025
/ Acquisitions ,
Anti-Kickback Statute ,
Artificial Intelligence ,
Cannabis Products ,
Clinical Trials ,
DEA ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Fraud ,
Hart-Scott-Rodino Act ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Laboratory Developed Tests ,
Life Sciences ,
Marijuana ,
Marketing ,
Medical Devices ,
Medical Marijuana ,
Mergers ,
Non-Compete Agreements ,
Pharmaceutical Industry ,
Prescription Drugs ,
Privacy Laws ,
Regulatory Agenda ,
Regulatory Requirements ,
Section 340B ,
Technology Sector ,
Telehealth ,
Telemedicine
With only two weeks remaining in the year, Congress is considering a government funding deal (the “Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025” or the “Bill”) that includes a...more
12/19/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Consolidated Appropriations Act (CAA) ,
Coronavirus/COVID-19 ,
Extensions ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
Medicare ,
New Legislation ,
Popular ,
Public Health Emergency ,
Technology ,
Telehealth ,
Telemedicine
On July 31, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued its proposed rule (“Proposed Rule”) for the 2025 Medicare Physician Fee Schedule, which includes implications for telehealth services reimbursable...more
This month, the Drug Enforcement Administration (“DEA”), in conjunction with the Substance Abuse and Mental Health Services Administration (“SAMHSA”), issued a Second Temporary Rule further extending the telemedicine waivers...more
10/18/2023
/ Controlled Substances ,
Coronavirus/COVID-19 ,
DEA ,
Electronic Prescribing ,
Health Care Providers ,
Healthcare ,
Life Sciences ,
Mental Health ,
Patient Access ,
Prescription Drugs ,
Public Health Emergency ,
SAMHSA ,
Telehealth ,
Telemedicine
This week, the Drug Enforcement Administration (“DEA”), in conjunction with the Substance Abuse and Mental Health Services Administration (“SAMHSA”), issued a temporary rule extending the telemedicine waivers of the Ryan...more
5/15/2023
/ Controlled Substances ,
Coronavirus/COVID-19 ,
DEA ,
Healthcare ,
Prescription Drugs ,
Public Health Emergency ,
Ryan Haight Act ,
SAMHSA ,
Telehealth ,
Telemedicine ,
Temporary Regulations ,
Waivers
The White House recently announced that the COVID-19 national emergency and public health emergency (PHE) declarations will end on May 11, 2023. These declarations have been in place since the beginning of the COVID-19...more
3/14/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Home Health Care ,
Hospice ,
Hospitals ,
Long Term Care Facilities ,
Medicaid ,
Public Health Emergency ,
Reasonable Expectation of Coverage ,
Regulatory Requirements ,
Rural Health Care Providers ,
Telehealth ,
Vaccinations ,
Virus Testing ,
Waivers
On February 24, 2023, the Drug Enforcement Agency (“DEA”) announced a new proposed rule, which provides some much-anticipated guidance related to the implications of telemedicine prescribing under Ryan Haight Act of 2008...more
3/8/2023
/ Comment Period ,
Controlled Substances ,
Controlled Substances Act ,
Coronavirus/COVID-19 ,
DEA ,
Healthcare ,
Patient Access ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Public Health Emergency ,
Ryan Haight Act ,
Telehealth ,
Telemedicine
The once-novel medium of telehealth surged onto the stage as a common sense solution to the COVID-19 pandemic. This surge was facilitated, in part, by certain flexibilities authorized by the Centers for Medicare & Medicaid...more
On February 13, 2023, the Centers for Medicare and Medicaid Services (CMS) published the revised List of Telehealth Services for Calendar Year (CY) 2023 (List). The List includes the services that are payable under the...more
Digital health services have exploded since the onset of the COVID-19 pandemic, and behavioral health services have seen large increases in utilization. Prior to the pandemic, telehealth visits for mental health or substance...more
Introduction On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023 (the “Act”). The Act provides for nearly $1.7 trillion in funding across a range of domestic initiatives, including certain...more
1/6/2023
/ Consolidated Appropriations Act (CAA) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Healthcare ,
Hospitals ,
Medicaid ,
Medicare ,
New Legislation ,
Physician Medicare Reimbursements ,
Rulemaking Process ,
Telehealth
The COVID-19 Public Health Emergency (“PHE”) led to a rapid expansion in the utilization of telehealth. Now, almost three years later, governmental entities have focused their attention on telehealth services and the...more
12/13/2022
/ Controlled Substances ,
Coronavirus/COVID-19 ,
DEA ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Health Care Providers ,
Healthcare Fraud ,
OIG ,
Prescription Drugs ,
Public Health Emergency ,
Ryan Haight Act ,
Telehealth
This blog is the first in our Digital Health Trends series.
Digital health’s explosion in the last few years has led to the proliferation of new technologies and novel solutions to long-standing health problems. FemTech,...more