The Centers for Medicare & Medicaid Services (CMS) on Oct. 31, 2025, released the calendar year (CY) 2026 Medicare Physician Fee Schedule (PFS) Final Rule, which includes policies related to Medicare physician payment and the...more
11/12/2025
/ Alternative Payment Models (APM) ,
Ambulance Providers ,
Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
Health Care Providers ,
MCOs ,
Medicare ,
Physician Fee Schedule ,
Physicians ,
Prescription Drugs ,
Regulatory Requirements ,
Reimbursements ,
Rural Health Care Providers ,
SaaS ,
Telehealth ,
Value-Based Care
This week, the government shutdown entered its fifth week and, on Nov. 4, 2025, became the longest in history, beating a 34-day-plus record set during President Donald Trump's first term. Meanwhile, the Open Enrollment Period...more
11/5/2025
/ Affordable Care Act ,
Center for Drug Evaluation and Research (CDER) ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Investigations & Hearings ,
Department of Education ,
Department of Justice (DOJ) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Government Shutdown ,
HRSA ,
International Emergency Economic Powers Act (IEEPA) ,
Medical Devices ,
Open Enrollment ,
Pharmaceutical Industry ,
Pilot Programs ,
Popular ,
Premium Subsidies ,
Prescription Drugs ,
Public Service Loan Forgiveness program (PSLF program) ,
SCOTUS ,
Section 301 ,
State Elections ,
Tariffs ,
Transgender
The federal government shutdown has now entered its fourth week, making it the third longest in U.S. history. Despite mounting pressure from both parties, no agreement has been reached to reopen the government. Lawmakers...more
10/29/2025
/ Affordable Care Act ,
Artificial Intelligence ,
CBO Report ,
Centers for Medicare & Medicaid Services (CMS) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Government Shutdown ,
Pharmaceutical Industry ,
Section 301 ,
Senate Committees ,
Supply Chain
As the government shutdown enters its fourth week, there is no clear end in sight. Democrats continue to insist that any bill to reopen and fund the government include an extension of the advanced premium tax credits (APTCs)...more
10/22/2025
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Congressional Investigations & Hearings ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Government Shutdown ,
Layoffs ,
Medicaid ,
Open Enrollment ,
Pregnancy ,
Premium Subsidies ,
Regulatory Agenda ,
Section 340B ,
Subsidies ,
Tax Credits ,
Vaccinations ,
Voluntary Reduction in Force
The government is a week into the first federal shutdown in seven years. Congressional negotiations remain at an impasse, and lawmakers have repeatedly failed to pass a stopgap spending bill despite the U.S. Senate holding...more
10/8/2025
/ Abortion ,
Affordable Care Act ,
Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Continuing Resolution ,
DEA ,
Department of Health and Human Services (HHS) ,
Department of Veterans Affairs ,
Executive Orders ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Government Shutdown ,
Inflation Reduction Act (IRA) ,
Medical Devices ,
Medicare Advantage ,
Prescription Drugs ,
Senate Committees
Extending funding for the federal government beyond Sept. 30, 2025, will be at the top of the U.S. Congress' agenda this week. Republicans in the U.S. House of Representatives are expected to release the text for a continuing...more
9/17/2025
/ Advertising ,
Affordable Care Act ,
Centers for Disease Control and Prevention (CDC) ,
Congressional Committees ,
Congressional Investigations & Hearings ,
Continuing Resolution ,
Department of Health and Human Services (HHS) ,
Federal Budget ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Government Shutdown ,
MACPAC ,
Medicare ,
New Guidance ,
New Legislation ,
No Surprises Act (NSA) ,
Prescription Drugs ,
SAMHSA ,
Telehealth ,
USDA
Both chambers of the U.S. Congress are in session this week, with the U.S. House of Representatives and U.S. Senate set to resume a packed schedule of hearings and legislative markups. While much of the attention in the House...more
9/10/2025
/ Affordable Care Act ,
Appropriations Bill ,
Artificial Intelligence ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Congressional Investigations & Hearings ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Healthcare ,
Medicare ,
NDAA ,
New Legislation ,
Prior Authorization ,
Senate Committees
U.S. Congress returns from the August 2025 recess for a short session. Both chambers will be forced to address a looming to-do list, namely potentially extending government funding beyond Sept. 30, 2025....more
9/4/2025
/ Appropriations Bill ,
Artificial Intelligence ,
Centers for Disease Control and Prevention (CDC) ,
Congressional Investigations & Hearings ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Government Shutdown ,
National Institute of Health (NIH) ,
Proposed Rules ,
Public Health ,
Tariffs ,
USAID ,
Vaccinations
In this episode of "Counsel That Cares," Public Policy & Regulation attorney John Vaughan, Healthcare attorney Dan Silverboard and Public Affairs Advisor Sarah Starling Crossan discuss the rapidly evolving landscape of...more
8/1/2025
/ Algorithms ,
Artificial Intelligence ,
Bias ,
Compliance ,
Data Privacy ,
Data Protection ,
Digital Health ,
Executive Orders ,
Health Care Providers ,
Health Technology ,
Machine Learning ,
New Legislation ,
New Regulations ,
Popular ,
Regulatory Oversight ,
Regulatory Requirements ,
Transparency
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
The White House released "Winning the Race: America's AI Action Plan" (Plan) on July 23, 2025, in accordance with President Donald Trump's Jan. 23, 2025, executive order on "Removing Barriers to American Leadership in...more
7/28/2025
/ Artificial Intelligence ,
Cybersecurity ,
Data Centers ,
Executive Orders ,
Export Controls ,
Federal Contractors ,
Federal Funding ,
Information Sharing ,
Innovation ,
National Security ,
Public Agencies ,
Semiconductors ,
Trump Administration
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
The Centers for Medicare & Medicaid Services (CMS) on July 15, 2025, issued the Hospital Outpatient Prospective Payment (OPPS) and Ambulatory Surgical Center (ASC) Payment Systems proposed rule, which proposes updates to the...more
7/21/2025
/ Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Drug Pricing ,
Healthcare ,
Hospitals ,
Medicare ,
Notice of Intent ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Price Transparency ,
Proposed Rules ,
Reporting Requirements ,
Request For Information ,
Rural Health Care Providers
The Centers for Medicare & Medicaid Services (CMS) on July 14, 2025, issued the calendar year (CY) 2026 Proposed Rule, which proposes payment policies and other outpatient services covered under Medicare Part B. Comments are...more
7/16/2025
/ Alternative Payment Models (APM) ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Health Care Providers ,
Healthcare Facilities ,
Home Health Care ,
Medicare ,
Medicare Part B ,
Mental Health ,
Physician Fee Schedule ,
Proposed Rules ,
Telehealth
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
President Donald Trump signed H.R. 1, known as the One Big Beautiful Bill Act (OBBB), into law on July 4, 2025. (For a detailed analysis of the bill, see Holland & Knight's previous alert, "Trump Signs the One Big Beautiful...more
7/14/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Federal Funding ,
Health Care Providers ,
Health Information Technologies ,
Healthcare ,
Hospitals ,
Information Technology ,
Mental Health ,
New Legislation ,
Rural Health Care Providers ,
Technology ,
Telehealth
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
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. 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
Looking Ahead: Fiscal Year 2026 Appropriations - This week, the U.S. House of Representatives and U.S. Senate return to Capitol Hill following the Memorial Day recess. The Senate is expected to begin work behind the scenes on...more
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
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