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
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
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
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
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
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
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
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
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
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
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
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
+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