This week, the U.S. House of Representatives will be out of session, as the chamber has adjourned for the August 2025 district work period. The U.S. Senate remains in session and continues to consider nominations to lead...more
7/30/2025
/ Affordable Care Act ,
Artificial Intelligence ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Investigations & Hearings ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Federal Funding ,
Health Care Providers ,
Health Insurance ,
Medicaid ,
New Legislation ,
Proposed Legislation ,
Senate Confirmation Hearings ,
Trade Agreements
With the One Big Beautiful Bill Act (OBBB) passed by U.S. Congress and signed into law, Congress now has less than three weeks that it will be in session before government funding expires on Sept. 30, 2025. Appropriators will...more
7/22/2025
/ Affordable Care Act ,
Appropriation ,
CBO Report ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Congressional Investigations & Hearings ,
Continuing Resolution ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Healthcare ,
Medicare ,
National Institute of Health (NIH) ,
New Legislation ,
Outpatient Prospective Payment System (OPPS) ,
Physician Fee Schedule ,
Prescription Drugs ,
Proposed Rules
Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and proposed regulatory changes that could dramatically impact the drug, biologics and...more
7/16/2025
/ Biologics ,
Consumer Protection Laws ,
Drug Pricing ,
Enforcement Actions ,
Expedited Approval Process ,
Expedited FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Recalls ,
Proposed Regulation ,
Public Policy ,
Regulatory Agenda ,
Regulatory Reform
The U.S. House of Representatives returns from a district work period. The U.S. Senate is expected to consider the $9.4 billion rescissions package that passed the House last month. If not passed by July 18, 2025, the...more
7/15/2025
/ Centers for Disease Control and Prevention (CDC) ,
Congressional Investigations & Hearings ,
Consumer Financial Protection Bureau (CFPB) ,
Cybersecurity ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Fair Credit Reporting Act (FCRA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Legislative Agendas ,
Medical Debt ,
Pharmacy Benefit Manager (PBM) ,
Proposed Legislation ,
Public Health ,
Public Policy ,
Senate Committees ,
Trump Administration ,
Vaccinations
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. Food and Drug Administration (FDA) is overhauling its approach to post-market oversight of food chemicals, marked by the proposed rollout of a new Post-Market Assessment Prioritization Tool. The FDA first announced...more
7/1/2025
/ Chemicals ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
GRAS ,
Proposed Rules ,
Public Health ,
REACH ,
Regulatory Oversight ,
Regulatory Reform ,
Risk Assessment ,
Rulemaking Process ,
Toxic Chemicals ,
Toxic Substances Control Act (TSCA)
Staff from U.S. Senate committees held meetings with the Senate parliamentarian over the weekend of June 20-22, 2025, to complete the "Byrd bath," a process by which committee staff make their case to the Senate...more
6/25/2025
/ Budget Reconciliation ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Department of Government Efficiency (DOGE) ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Reform ,
Medicaid ,
Medicare ,
Proposed Legislation ,
Senate Committees
The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) announced on June 17, 2025, the creation of a new initiative called the "Commissioner's National Priority Voucher" (CNPV)...more
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 is in session for three days this week while the U.S. House of Representatives is in recess all week. Both chambers will return for a week before breaking for the July 4 recess. Negotiations on the...more
6/18/2025
/ Budget Reconciliation ,
Congressional Committees ,
Congressional Investigations & Hearings ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Reform ,
Medicaid ,
Medical Research ,
Medicare ,
MedPAC ,
National Institute of Health (NIH) ,
Proposed Legislation
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 U.S. Food and Drug Administration (FDA) has announced a new initiative to systematically review the safety of chemicals already in the nation's food supply....more
5/23/2025
/ Chemicals ,
EU ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
FIFRA ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
Proposed Rules ,
Proposition 65 ,
Public Comment ,
Regulatory Oversight ,
Regulatory Reform ,
Toxic Chemicals ,
Toxic Substances Control Act (TSCA)
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
U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced on March 10, 2025, that he directed the acting commissioner of the U.S. Food and Drug Administration (FDA) to explore potential...more
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
3/12/2025
/ Affordable Care Act ,
CBO Report ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Federal Funding ,
Food and Drug Administration (FDA) ,
General Services Administration (GSA) ,
GRAS ,
Health Care Providers ,
Legislative Agendas ,
Medicare ,
Tariffs