Updated November 18, 2024 – The Consolidated Appropriations Act (CAA), 2023 (Public Law 117-328), signed into law on December 29, 2022, extended certain key telehealth flexibilities instituted during the COVID-19 public...more
11/19/2024
/ Acute Facilities ,
Consolidated Appropriations Act (CAA) ,
Controlled Substances Act ,
DEA ,
Health Care Providers ,
Health Insurance ,
Health Savings Accounts ,
Healthcare ,
Healthcare Reform ,
Home Health Care ,
Lame Duck Session ,
Legislative Agendas ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health Emergency ,
Regulatory Agenda ,
Telehealth ,
Telemedicine
The Consolidated Appropriations Act (CAA), 2023 (Public Law 117-328), signed into law on December 29, 2022, extended certain key virtual care flexibilities instituted during the COVID-19 public health emergency (PHE) through...more
11/12/2024
/ Consolidated Appropriations Act (CAA) ,
Controlled Substances ,
DEA ,
HDHP ,
Health Insurance ,
Health Savings Accounts ,
Healthcare ,
Healthcare Reform ,
Lame Duck Session ,
Legislative Agendas ,
Medicare ,
Pharmaceutical Industry ,
Public Health Emergency ,
Regulatory Agenda ,
Telehealth ,
Telemedicine
A new rule posted on the Office of Management and Budget (OMB) registry suggests that the Drug Enforcement Administration (DEA) is planning an additional extension of COVID-19 flexibilities for telemedicine prescribing of...more
10/14/2024
/ Controlled Substances ,
Controlled Substances Act ,
Coronavirus/COVID-19 ,
DEA ,
Healthcare ,
OMB ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health Emergency ,
Telehealth ,
Telemedicine
The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more
6/20/2024
/ Artificial Intelligence ,
Biologics ,
Cannabis Products ,
Clinical Trials ,
Food and Drug Administration (FDA) ,
Healthcare ,
Laboratory Developed Tests ,
Legislative Agendas ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Medical Marijuana ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Requirements ,
Technology
May 11, 2024, marked one year since the end of the COVID-19 public health emergency (PHE), and not much has changed in Medicare telehealth policy. We are still operating under temporary waivers and flexibilities and, as a...more
5/15/2024
/ Controlled Substances ,
Coronavirus/COVID-19 ,
DEA ,
Electronic Prescribing ,
Health Care Providers ,
Health Savings Accounts ,
Healthcare ,
Legislative Agendas ,
Life Sciences ,
Mental Health ,
Patient Access ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health Emergency ,
Telehealth ,
Telemedicine
Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more
5/9/2024
/ Affordable Care Act ,
American Health Care Act (AHCA) ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratory Testing ,
DACA ,
Federal Trade Commission (FTC) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Laboratory Developed Tests ,
Life Sciences ,
Managed Care Contracts ,
Medicaid ,
Non-Compete Agreements ,
Non-Discrimination Rules ,
Nursing Homes ,
Pharmaceutical Industry ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Requirements ,
Senate Committees ,
U.S. House
The price of prescription drugs has brought scrutiny to the entire drug supply chain. Congress and other policymakers continue to seek opportunities to lower costs for patients and the federal government.
Pharmacy benefit...more
9/6/2023
/ Drug Pricing ,
MCOs ,
Medicare ,
Medicare Advantage ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drug Coverage ,
Prescription Drugs ,
Supply Chain
August 31, 2023 – When it comes to prescription drug costs, policymakers have set their focus on the consumer:
“Let’s lower drug prices for the consumer.”
“Let’s give consumers more options in paying their out-of-pocket...more
8/31/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Negotiations ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Rebates ,
Transparency
McDermott’s digital health team continually monitors legal developments affecting all aspects of the remote delivery of care. This inaugural issue of our Of Digital Interest Quarterly Roundup highlights key issues and trends...more
4/28/2023
/ Banking Sector ,
Controlled Substances ,
DEA ,
Digital Health ,
Financial Crisis ,
Health Care Providers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Agenda ,
Rulemaking Process ,
Silicon Valley ,
State and Local Government ,
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