Key Takeaways -
- CMS is expected to issue the 2026 final rate notice for Medicare Advantage (MA) and Part D plans by April 7, 2025.
- The January 2025 advance notice proposed policies that would increase payments to MA...more
Republicans hold a trifecta of control after winning the White House, US Senate, and US House of Representatives for the 119th Congress. They will aim to pass an agenda backed by President Trump that is focused on tax cuts,...more
1/31/2025
/ Byrd Amendment ,
Congressional Budget Act of 1974 ,
Energy Sector ,
Federal Budget ,
Healthcare ,
Healthcare Reform ,
Immigration ,
Legislative Agendas ,
Reconciliation ,
Senate Committees ,
Tax Reform ,
Trump Administration ,
U.S. House
The Trump Administration and 119th Congress will likely be targeting trillions of dollars in savings in the year ahead. Healthcare makes up a significant portion of mandatory spending and therefore likely will be a large part...more
1/24/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Federal Budget ,
Healthcare ,
Healthcare Reform ,
Medicaid ,
Medicare ,
Medicare Advantage ,
Medicare Payment Reform ,
MedPAC ,
Section 340B ,
Trump Administration
On January 15, 2025, the US Drug Enforcement Administration (DEA) released a proposed rule entitled Special Registrations for Telemedicine and Limited State Telemedicine Registrations. This proposed rule would establish three...more
1/20/2025
/ Controlled Substances ,
Coronavirus/COVID-19 ,
DEA ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Life Sciences ,
Prescription Drugs ,
Proposed Rules ,
Public Health Emergency ,
Regulatory Agenda ,
Technology Sector ,
Telehealth ,
Telemedicine ,
Trump Administration
At the close of 2024, US Congress passed a short-term extension of Medicare telehealth flexibilities as part of the American Relief Act, 2025 (ARA). The Medicare telehealth waivers, originally enacted as part of the COVID-19...more
On December 3, 2024, the US Food and Drug Administration (FDA) published final guidance titled, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software...more
On October 10, 2024, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced its agenda of proposed guidance documents to be published or developed in the 2025 fiscal year (FY)....more
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
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
On October 29, 2024, the US Department of Justice (DOJ) issued a proposed rule to implement US President Joe Biden’s Executive Order (EO) 14117 aimed at preventing access to Americans’ sensitive personal data and...more
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
On November 1, 2024, the Centers for Medicare & Medicaid Services (CMS) released the calendar year (CY) 2025 Revisions to Payment Policies Under the Physician Fee Schedule (PFS) and Other Revisions to Medicare Part B...more
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
On September 9, 2024, the US Departments of Health and Human Services (HHS), Labor, and the Treasury (collectively, the Departments) finalized a rule titled Requirements Related to the Mental Health Parity and Addiction...more
The Centers for Medicare & Medicaid Services (CMS) issued the final procedural notice on Transitional Coverage for Emerging Technologies (TCET), effective as of August 12, 2024. TCET is a new pathway that uses existing...more
Last week, the Centers for Medicare & Medicaid Services (CMS) issued a final procedural notice for the new Transitional Coverage for Emerging Technologies (TCET) pathway for certain US Food & Drug Administration (FDA)...more
Legislative Uncertainty on Telehealth Waivers Slows Down, But Doesn’t Halt, Regulatory Action on Virtual Care McDermott+ is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey Davis. Click here to...more
On July 10, 2024, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2025 Revisions to Payment Policies Under the Physician Fee Schedule (PFS) and Other Revisions to Medicare Part B...more
On July 10, 2024, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2025 Revisions to Payment Policies Under the Physician Fee Schedule (PFS) and Other Revisions to Medicare Part B...more
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
Where has the time gone? We have hit the one-year mark since the end of the COVID-19 public health emergency (PHE). Yes, you read that correctly. One year!
One of the long-term consequences of the PHE was the shift in when...more
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
On April 29, 2024, the US Food and Drug Administration (FDA) issued the long-awaited final rule around the regulation of laboratory developed tests (LDTs), which are in vitro diagnostic products (IVDs) that FDA describes as...more
During this election year, McDermottPlus is actively monitoring annual regulations that federal agencies are expected to release, as well as “ad hoc” regulations that will be released at the discretion of federal agencies. ...more
4/26/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
DEA ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Department of Veterans Affairs ,
Employee Benefits ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health and Welfare Plans ,
Healthcare ,
Healthcare Reform ,
New Regulations ,
OCR ,
OIG ,
OSHA ,
Proposed Regulation ,
Regulatory Agenda ,
Regulatory Reform