With the reconciliation package signed into law, the U.S. House of Representatives is in recess and will return on July 14, 2025. In the interim, the U.S. Senate will focus on the appropriations bills for fiscal year (FY)...more
7/10/2025
/ Affordable Care Act ,
Appointments Clause ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Constitutional Challenges ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
HRSA ,
Medicaid ,
Medicare ,
New Legislation ,
SCOTUS ,
Section 340B ,
Transgender ,
Trump Administration
The U.S. House of Representatives Committee on Energy and Commerce's Subcommittee on Health held a recent hearing titled "Made in America: Strengthening Domestic Manufacturing and the Health Care Supply Chain." The hearing...more
6/19/2025
/ APIs ,
Congressional Committees ,
Congressional Investigations & Hearings ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
New Legislation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Reform ,
Risk Assessment ,
Supply Chain ,
Trump Administration
The U.S. Senate will likely release additional sections of the reconciliation package this week. It is unlikely the Senate Committee on Finance, which has jurisdiction over Medicaid, will hold a markup on its portion of the...more
6/11/2025
/ Abortion ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Congressional Investigations & Hearings ,
Controlled Substances Act ,
DEA ,
Department of Health and Human Services (HHS) ,
EMTALA ,
Federal Budget ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Medicaid ,
Medicare ,
National Institute of Health (NIH) ,
Proposed Legislation ,
Senate Committees ,
Trump Administration
The Make America Healthy Again (MAHA) Commission, as established by President Donald Trump's Feb. 13, 2025, Executive Order (EO) 14212, released its inaugural report on May 22, 2025, titled "The MAHA Report: Making Our...more
5/27/2025
/ Artificial Intelligence ,
Chemicals ,
Clinical Trials ,
Environmental Protection Agency (EPA) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Supply ,
Information Reports ,
Pesticides ,
Prescription Drugs ,
Public Health ,
Regulatory Reform ,
Toxic Chemicals ,
Trump Administration
The budget reconciliation package is expected to be considered by the full U.S. House of Representatives as soon as May 22, 2025. The House Committee on Rules is scheduled to meet on May 21, 2025, at which time additional...more
5/22/2025
/ ACOs ,
Baby Products ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Investigations & Hearings ,
Department of Health and Human Services (HHS) ,
Deregulation ,
Drinking Water ,
Drug Pricing ,
Federal Budget ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Reform ,
HIPAA Privacy Rule ,
MCOs ,
Medicaid ,
Medicare ,
Prescription Drugs ,
Proposed Legislation ,
Request For Information ,
Trump Administration
The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) issued a Request for Information (RFI) on May 13, 2025, titled "Ensuring Lawful Regulation and Unleashing Innovation to...more
U.S. House of Representatives committees are scheduled to begin markups on additional portions of the budget reconciliation package on May 13, 2025. Both the House Committee on Ways and Means and the House Committee on Energy...more
5/14/2025
/ Administrative Appointments ,
Artificial Intelligence ,
Budget Reconciliation ,
Children's Health Insurance Program (CHIP) ,
Congressional Committees ,
Congressional Investigations & Hearings ,
Department of Health and Human Services (HHS) ,
Federal Budget ,
Food and Drug Administration (FDA) ,
Healthcare ,
Legislative Agendas ,
Medicaid ,
Medical Research ,
Medicare ,
Medicare Part D ,
National Institute of Health (NIH) ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Legislation ,
Supply Chain ,
Trump Administration
Reconciliation markups in the U.S. House of Representatives Committee on Energy and Commerce, as well as the House Committee on Ways and Means, were expected to be held this week but have been postponed until next week at the...more
5/7/2025
/ Budget Reconciliation ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Executive Orders ,
Government Agencies ,
Health Insurance ,
Healthcare Reform ,
Medicaid ,
Medicare Advantage ,
National Institute of Health (NIH) ,
OSTP ,
Proposed Legislation ,
Public Comment ,
Restructuring ,
Trump Administration
The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) on April 22, 2025, announced their intent to phase out the use of certain food additives, including petrochemical-based dyes,...more
The U.S. Department of Commerce announced that it has initiated a Trade Expansion Act of 1962 Section 232 investigation to determine whether imports of pharmaceutical products and ingredients pose a national security risk to...more
4/17/2025
/ Comment Period ,
Countermeasures ,
Executive Orders ,
Government Investigations ,
Imports ,
National Security ,
Pharmaceutical Industry ,
Public Comment ,
Section 232 ,
Supply Chain ,
Tariffs ,
Trade Expansion Act of 1962 ,
Trade Policy ,
Trump Administration ,
U.S. Commerce Department ,
US Trade Policies
Looking Ahead: House to Vote on Compromise Budget Resolution On the heels of the U.S. Senate's passage of a compromise budget resolution, the U.S. House of Representatives is expected to consider the budget resolution on the...more
4/9/2025
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Investigations & Hearings ,
Drug Pricing ,
Executive Orders ,
Federal Budget ,
Federal Grants ,
Healthcare ,
Legislative Agendas ,
MACPAC ,
Medicare ,
Medicare Part D ,
MedPAC ,
National Institute of Health (NIH) ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Regulatory Agenda ,
Tariffs ,
Trump Administration
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
4/3/2025
/ Congressional Investigations & Hearings ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Executive Orders ,
Federal Budget ,
Federal Funding ,
Federal Grants ,
Healthcare ,
Involuntary Reduction in Force ,
Legislative Agendas ,
New Legislation ,
Presidential Nominations ,
Regulatory Requirements ,
Senate Confirmation Hearings ,
Trump Administration
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
3/26/2025
/ Centers for Disease Control and Prevention (CDC) ,
Congressional Investigations & Hearings ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Federal Budget ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
Regulatory Agenda ,
Regulatory Requirements ,
Trump Administration
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
3/21/2025
/ Centers for Disease Control and Prevention (CDC) ,
CMMI ,
Continuing Resolution ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Health Information Technologies ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
Office of Personnel Management (OPM) ,
Pending Legislation ,
Policy Updates ,
Public Health ,
Regulatory Agenda ,
Regulatory Requirements ,
Tariffs ,
Trump Administration ,
World Health Organization
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
2/13/2025
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Deregulation ,
Executive Orders ,
Federal Funding ,
Health Insurance ,
Healthcare Reform ,
Legislative Agendas ,
Medicare ,
Regulatory Agenda ,
Regulatory Requirements ,
Trump Administration
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
1/31/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Federal Funding ,
Federal Trade Commission (FTC) ,
Final Rules ,
Health Care Providers ,
Healthcare Reform ,
Legislative Agendas ,
New Legislation ,
OMB ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Requirements ,
Trump Administration
Holland & Knight Health Dose Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
1/23/2025
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Investigations & Hearings ,
Constitutional Challenges ,
Department of Health and Human Services (HHS) ,
Federal Trade Commission (FTC) ,
Health Information Technologies ,
Health Insurance ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
MedPAC ,
New Legislation ,
Public Health ,
Regulatory Agenda ,
SCOTUS ,
Telemedicine ,
Trump Administration
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector.
This week's topics include ...more
1/17/2025
/ Congressional Committees ,
Congressional Intent ,
Department of Health and Human Services (HHS) ,
Federal Funding ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
Medicaid ,
Medicare ,
New Legislation ,
Regulatory Agenda ,
Trump Administration