HELP Committee Releases 340B Report. Health, Education, Labor, and Pensions (HELP) Chair Cassidy (R-LA) released findings from his investigation and laid out potential reforms to the 340B Drug Pricing Program....more
On April 11, 2025, the Centers for Medicare & Medicaid Services (CMS) issued the fiscal year (FY) 2026 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment...more
THIS WEEK’S DOSE -
House Passes Concurrent Budget Resolution for Reconciliation Process. Passage of the resolution didn’t resolve the policy differences between the House and the Senate. Those still need to be addressed as...more
THIS WEEK’S DOSE -
- Reconciliation Moves Forward with Senate Introduction of Concurrent Budget Resolution. This move initiates the next stage in the reconciliation process, which requires House and Senate passage of a...more
Senate Confirms FDA, NIH Nominations, Advances CMS Nomination. On March 25, 2025, the Senate confirmed Martin Makary, MD, as the next FDA commissioner by a 56 – 44 vote. Sens. Durbin (D-IL), Hassan (D-NH), and Shaheen (D-NH)...more
3/31/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Medicare Advantage ,
National Institute of Health (NIH) ,
New Legislation ,
Presidential Nominations ,
Proposed Legislation ,
Senate Confirmation Hearings ,
Trump Administration
Government Is Funded, Congress at Home for the Week. On March 15, 2025, President Trump signed a continuing resolution (CR) into law that funds the government and provides short-term extensions of certain healthcare programs...more
3/24/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Healthcare ,
Healthcare Reform ,
Medicaid ,
Medicare ,
Regulatory Agenda ,
Technology Sector ,
Telehealth ,
Trump Administration
On January 14, 2025, the US Departments of Labor, Health and Human Services (HHS), and the Treasury (collectively, the Departments), along with the Office of Personnel Management (OPM), jointly issued Part 69 of a series of...more
3/18/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Cost-Sharing ,
Department of Health and Human Services (HHS) ,
Disclosure Requirements ,
Dispute Resolution ,
Final Rules ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Medicaid ,
New Guidance ,
No Surprises Act (NSA) ,
Regulatory Requirements ,
Trump Administration
THIS WEEK’S DOSE -
- Congress Debates Government Funding. A continuing resolution (CR) to fund the government through September passed the House and may pass the Senate today.
- Senate HELP Committee Advances NIH, FDA...more
3/17/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
Medicaid ,
Medicare ,
Proposed Rules ,
Public Health ,
Regulatory Agenda
Government Funding Deadline, Healthcare Program Expirations Approach. Following recent House and Senate passage of their competing budget resolutions, Congress’ attention has now turned to the March 14, 2025, government...more
3/10/2025
/ Continuing Resolution ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
EMTALA ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
Medicaid ,
Medicare ,
Presidential Nominations ,
Senate Finance Committee ,
Trump Administration
On March 5, 2025, the Center for Clinical Standards and Quality (CCSQ) within the Centers for Medicare & Medicaid Services (CMS) released a Quality & Safety Special Alert Memo for hospitals related to President Trump’s...more
House Passes Budget Resolution. On February 25, the House voted 217 – 215 to advance its version of a budget resolution to outline the reconciliation process. In a dramatic display of how quickly things can change, the vote...more
3/3/2025
/ Artificial Intelligence ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
Medicaid ,
Medicare ,
New Legislation ,
Pharmacy Benefit Manager (PBM) ,
Technology Sector ,
Trump Administration
Senate Passes Budget Resolution. Last week, the Senate and House Budget Committees each passed separate, and very different, budget resolutions as their first steps toward negotiating a unified budget resolution that must...more
RFK Jr. Confirmed as HHS Secretary. In a 52 – 48 Senate vote, Robert F. Kennedy (RFK) Jr. was confirmed as the next HHS secretary. All Democrats voted no, and Sen. McConnell (R-KY) was the only Republican to join them. He...more
2/14/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
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Medicaid ,
Medicare ,
National Institute of Health (NIH) ,
Public Health ,
Regulatory Agenda ,
Trump Administration
Key Nominations Move Forward. The Senate Finance Committee advanced Robert F. Kennedy (RFK) Jr.’s nomination to lead the US Department of Health & Human Services (HHS) in a 14 – 13 vote along party lines. The nomination now...more
2/10/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Gender Identity ,
Healthcare ,
Healthcare Reform ,
Medicaid ,
Medicare ,
Opioid ,
Presidential Nominations ,
Public Health ,
Senate Committees ,
Senate Confirmation Hearings ,
Trump Administration ,
U.S. House
Senate Finance, HELP Committees Hold RFK Jr. Nomination Hearings. RFK Jr., nominated for Secretary of Health and Human Services (HHS), testified before the Senate Finance Committee on January 29 and before the Senate Health,...more
1/31/2025
/ Abortion ,
Department of Health and Human Services (HHS) ,
Department of Veterans Affairs ,
Executive Orders ,
Food Safety ,
Healthcare ,
Healthcare Reform ,
HELP ,
Legislative Agendas ,
Medicaid ,
Presidential Nominations ,
Regulatory Agenda ,
Senate Finance Committee ,
Transgender ,
Transparency ,
Trump Administration
One of the Biden Administration’s last healthcare regs was a proposed rule that, if finalized, would make significant changes to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule to...more
1/30/2025
/ Biden Administration ,
Business Associates ,
Comment Period ,
Cybersecurity ,
Data Breach ,
Data Security ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Proposed Rules ,
Risk Management ,
Trump Administration
Senate Committees Continue Nomination Hearings. The Senate VA Committee held a hearing for VA secretary nominee Doug Collins and subsequently voted for his confirmation with broad bipartisan support. His confirmation vote...more
1/27/2025
/ Affordable Care Act ,
Artificial Intelligence ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Executive Orders ,
Federal Budget ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
Medicaid ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Reform ,
Trump Administration ,
World Health Organization
House Committees Organize, Senate Committees Begin Nomination Hearings. House healthcare committees held organizing meetings and announced subcommittee assignments, while Senate committees held nomination hearings for...more
On December 17, 2024, the US Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP) published the Health Data,...more
1/15/2025
/ 21st Century Cures Act ,
Compliance ,
Data Privacy ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
Privacy Laws ,
Reproductive Healthcare Issues
119th Congress Begins. The new Congress began with key membership announcements for relevant healthcare committees. Cures 2.1 White Paper Published. The document outlines the 21st Century Cures 2.1 legislative proposal,...more
118th Congress Continues to Grapple with Contentious CR. With the collapse of Republican support for the negotiated continuing resolution (CR) package, as of the time of publication on Friday at 3:00 PM EST, Congress is still...more
12/23/2024
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Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
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Healthcare ,
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Legislative Agendas ,
Machine Learning ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
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Regulatory Agenda ,
Technology ,
U.S. House
Senate Special Committee on Aging Holds Hearing on People with Disabilities. Senators and witnesses acknowledged the significant barriers that exist for Americans with disabilities and discussed current and proposed federal...more
12/16/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Disabilities ,
Federal Trade Commission (FTC) ,
Final Rules ,
GAO ,
Healthcare ,
Healthcare Reform ,
Home and Community Based Services (HCBS) ,
Legislative Agendas ,
Medicare Advantage Organizations (MAOs) ,
MedPAC ,
NDAA ,
OIG ,
Regulatory Agenda ,
Senate Committees ,
U.S. House ,
Veterans' Benefits
The No Surprises Act, a law that ended the practice of “balance billing” by certain out-of-network providers, was enacted as part of the Consolidated Appropriations Act of 2021 on December 27, 2020. While the law passed...more
12/12/2024
/ Billing ,
Centers for Medicare & Medicaid Services (CMS) ,
Consolidated Appropriations Act (CAA) ,
Department of Health and Human Services (HHS) ,
Dispute Resolution ,
Enforcement Actions ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
No Surprises Act (NSA) ,
Out of Network Provider ,
Regulatory Agenda ,
Surprise Medical Bills ,
Trump Administration
Congress Negotiates Healthcare Extenders, Continues to Plan for 2025. Lawmakers continue negotiations to wrap up the 118th Congress and pass remaining must-do policies, including government funding, likely through a...more
12/9/2024
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Department of Health and Human Services (HHS) ,
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Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
Machine Learning ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
Regulatory Agenda ,
Section 340B ,
Technology ,
U.S. House
Congress Begins Disaster Relief Efforts, Continues Organizing for 119th Congress. In the aftermath of Hurricanes Helene and Milton, lawmakers are focused on funding an emergency supplemental disaster relief package. President...more
11/25/2024
/ Cybersecurity ,
DEA ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Lame Duck Session ,
Legislative Agendas ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Telehealth ,
Telemedicine ,
Trump Administration