It’s been more than two weeks since the release of the CY 2026 Medicare Physician Fee Schedule (PFS) proposed rule. We’ve had a chance to digest our initial helping and now we’re ready for seconds. We thought we would see...more
7/31/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Digital Health ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Insurance Industry ,
Medical Devices ,
Medicare ,
Medicare Fraud ,
Mental Health ,
Technology ,
Telehealth
The world of health benefits is constantly evolving. Recent policy shifts and legislative developments are expected to impact the economic landscape and have significant implications for employer plan sponsors, insurers,...more
7/28/2025
/ Affordable Care Act ,
Compliance ,
Employee Benefits ,
Employee Retirement Income Security Act (ERISA) ,
Employer Group Health Plans ,
HDHP ,
HDHPs ,
Health Insurance ,
Health Savings Accounts ,
Healthcare ,
Healthcare Reform ,
HSA ,
Insurance Industry ,
Medicaid ,
Mental Health ,
Mental Health Parity Rule ,
Regulatory Requirements ,
Telehealth ,
TPAs
On July 4, 2025, the president signed the One Big Beautiful Bill Act (H.R. 1) into law. Among many other healthcare provisions, the bill permanently extends the telehealth safe harbor for high-deductible health plans (HDHPs)...more
7/21/2025
/ Affordable Care Act ,
Digital Health ,
Employee Benefits ,
Employer Group Health Plans ,
HDHP ,
HDHPs ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
New Legislation ,
Safe Harbors ,
Technology ,
Telehealth ,
Telemedicine
On July 15, 2025, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2026 Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems Proposed Rule [CMS-1834-P],...more
7/18/2025
/ Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Financial Services Industry ,
Healthcare ,
Healthcare Reform ,
Medicare ,
Outpatient Prospective Payment System (OPPS) ,
Payment Systems ,
Proposed Rules ,
Regulatory Requirements ,
Reporting Requirements
On July 14, 2025, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2026 Revisions to Payment Policies Under the Physician Fee Schedule (PFS) and Other Revisions to Medicare Part B [CMS-13271]...more
7/17/2025
/ Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Healthcare ,
Healthcare Reform ,
Insurance Industry ,
Medicare ,
Medicare Part B ,
Medicare Shared Savings Program ,
New Regulations ,
Physician Fee Schedule ,
Proposed Rules ,
Regulatory Agenda ,
Technology ,
Telehealth
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
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
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
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
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
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
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
The Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) final rule, issued by the US Department of Health and Human Services (HHS) Office of...more
4/10/2024
/ Algorithms ,
Artificial Intelligence ,
Certification Requirements ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Health Information Technologies ,
Healthcare ,
Information Technology ,
ONC ,
Risk Management ,
Technology
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
What does December 31, 2024, mean to you? New Year’s Eve? Post-2024 election? Too far away to know?
Our answer: December 31, 2024, is when we will go over a “telehealth cliff” if Congress fails to act before that date,...more
Happy New Year! As we enter 2024, we want to lay out some of the main regulatory issues (both new and old) that McDermott+Consulting will be tracking over the next year. While these may evolve, we think they are still...more
1/4/2024
/ Artificial Intelligence ,
CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Healthcare Reform ,
Laboratory Developed Tests ,
Managed Care Contracts ,
Medicaid ,
Medicare ,
MIPS ,
No Surprises Act (NSA) ,
Physician Fee Schedule ,
Proposed Regulation ,
Regulatory Agenda ,
Regulatory Reform ,
Telehealth ,
Telemedicine
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