Many healthcare programs are extended for specific time periods, as short as one or two years or as long as 10, and are usually attached to a larger piece of must-pass legislation. Additionally, while traditional...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
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 The Medicare telehealth waivers, originally enacted as part of the COVID-19...more
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
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
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
A few weeks ago, Regs & Eggs highlighted the major issues that McDermott+Consulting is monitoring this year – and the implementation of the president’s executive order (EO) on artificial intelligence (AI) was definitely part...more
2/1/2024
/ Artificial Intelligence ,
Biden Administration ,
Deadlines ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Health Care Providers ,
Health Information Technologies ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
Machine Learning ,
New Legislation ,
ONC ,
State and Local Government ,
State Legislatures ,
Technology
A few weeks ago, Regs & Eggs discussed the constant give and take between federal agencies and Congress as they both work on overlapping policies and objectives. The major regs released last week provide an excellent example...more
11/9/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
New Legislation ,
Outpatient Prospective Payment System (OPPS) ,
Physician Fee Schedule ,
Price Transparency ,
Proposed Legislation ,
Senate Committees ,
Telehealth ,
U.S. House
On October 30, 2023, the White House released a long-awaited Executive Order (EO) on the “Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence.” The EO acknowledges the transformative potential of AI...more
11/1/2023
/ Artificial Intelligence ,
Biden Administration ,
Data Security ,
Executive Orders ,
Healthcare ,
Healthcare Reform ,
Innovative Technology ,
Legislative Agendas ,
New Legislation ,
New Regulations ,
Privacy Laws ,
Regulatory Agenda ,
Regulatory Requirements ,
Technology
On September 29, 2023, the US Food and Drug Administration (FDA) published a long-awaited proposed rule on laboratory-developed tests (LDTs). If FDA finalizes this rule as proposed, FDA will regulate virtually all LDTs as...more
Congress and federal agencies often engage in a game, each trying to see what the other is willing to do to achieve a particular policy or outcome. While Congress and federal agencies have unique authorities (legislative...more
10/5/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratories ,
Congressional Committees ,
Diagnostic Tests ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Legislative Agendas ,
Life Sciences ,
Medical Devices ,
Medicare Advantage ,
Proposed Rules
In the 118th Congress, the US House of Representatives is keenly interested in price transparency in healthcare. Three House committees—Energy and Commerce, Ways and Means and Education and the Workforce—each approved...more
During this session, panelists offered insights into the regulatory action, rulemaking and legislation shaping the future of digital health, with a particular focus on artificial intelligence (AI), data privacy and the end of...more
6/19/2023
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Data Privacy ,
Digital Health ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
Proposed Legislation ,
Proposed Regulation ,
Public Health Emergency ,
Regulatory Agenda ,
Telehealth
+Dx Forum 2023 is the premier gathering for the laboratory diagnostics community.
Join us for insightful discussion about the latest regulatory and reimbursement developments....more
2/1/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratories ,
Diagnostic Tests ,
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) ,
Events ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Reform ,
Laboratory Developed Tests ,
Legislative Agendas ,
Medicare Administrative Contractors (MAC) ,
Prior Authorization ,
Regulatory Agenda ,
Reimbursements