President Donald Trump on May 12, 2025, issued an executive order (EO) titled "Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients" and an accompanying Fact Sheet, "President Donald J. Trump...more
5/15/2025
/ Commerce Clause ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Imports ,
Inflation Reduction Act (IRA) ,
Medicaid ,
Medicare ,
Most-Favored Nations ,
Pharmaceutical Industry ,
Trump Administration ,
U.S. Commerce Department ,
USTR
The Centers for Medicare & Medicaid Services (CMS) on April 11, 2025, issued the proposed fiscal year (FY) 2026 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Acute Care Hospital (LTCH) Rule...more
4/25/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Deregulation ,
Executive Orders ,
Healthcare Facilities ,
Hospitals ,
Inpatient Prospective Payment System (IPPS) ,
Long Term Care Facilities ,
Medicare ,
Proposed Rules ,
Regulatory Requirements ,
Reimbursements ,
Request For Information ,
Rulemaking Process ,
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
The Center for Medicare and Medicaid Innovation (CMMI) has released a statement on plans to unveil a new strategy focused on "improving the health of Americans through disease prevention via evidence-based practices,...more
3/19/2025
/ ACOs ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Medicaid ,
Medicare ,
Trump Administration ,
Value-Based Care
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 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
The Centers for Medicare & Medicaid Services (CMS) released the Final Rule implementing the Increasing Organ Transplant Access Model (IOTA Model) on Nov. 26, 2024. This mandatory payment model introduces financial incentives...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
The U.S. Supreme Court on June 17, 2021, ruled 7-2 that Republican states, led by Texas, lack standing to challenge the Affordable Care Act (ACA). In the case of California et al. v. Texas et al., Justice Stephen Breyer wrote...more
On June 24, 2019, President Trump signed a long-awaited executive order that he said would "fundamentally" change the healthcare market. The order builds upon current regulations that require hospitals to make available a...more
6/26/2019
/ Data Reporting ,
Disclosure Requirements ,
Executive Orders ,
Health Care Providers ,
Health Insurance ,
Health Savings Accounts ,
Healthcare Costs ,
Hospitals ,
Out-of-Pocket Expenses ,
Outpatient Prospective Payment System (OPPS) ,
Price Transparency ,
Proposed Rules ,
Surprise Medical Bills ,
Trump Administration
President Trump's budget was released yesterday as the fiscal year (FY) 2020 appropriations process ramps up. The FY 2020 budget requests $87.1 billion in discretionary funding for the Health and Human Services (HHS)...more
3/14/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Emergency Rooms ,
Federal Budget ,
FQHC ,
Health Care Providers ,
Medicaid ,
Medicare ,
Public Health ,
Trump Administration ,
Veterans Administration
On Jan. 31, 2019, the Department of Health and Human Services' (HHS) Office of the Inspector General (OIG) issued a long-awaited proposed rule that would, if finalized, remove the existing legal "safe harbor" that protects...more
2/5/2019
/ Comment Period ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Exemptions ,
Health Care Providers ,
Health Plan Sponsors ,
Manufacturers ,
MCOs ,
Medicaid ,
Medicare ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Rebates ,
Safe Harbors ,
Trump Administration
Healthcare was a top voter priority in the 2018 midterm elections, with 41 percent of national voters stating that healthcare was their "most important" issue. Accordingly, the Democratic strategy to focus on healthcare...more
11/13/2018
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance ,
Healthcare Reform ,
Legislative Agendas ,
Medicaid ,
Medicaid Expansion ,
Medicare ,
Trump Administration
On Aug. 1, 2018, the Departments of Health and Human Services (HHS), Labor and Treasury jointly issued the Short-Term, Limited-Duration Insurance Final Rule. The rule is the second of three regulations resulting from...more
Opioid Funding Overview -
In 2016, through the Comprehensive Addiction and Recovery Act (CARA) and the 21st Century Cures Act, Congress authorized roughly $1.4 billion in spending to combat the opioid crisis....more
4/9/2018
/ Appropriations Bill ,
Bi-Partison Balanced Budget Act (BBA) ,
Bipartisan Budget Act ,
Comprehensive Addiction and Recovery Act of 2016 (CARA) ,
Drug Treatment ,
Federal Funding ,
Grants ,
HELP ,
Legislative Agendas ,
Medicare Part D ,
Opioid ,
Prescription Drugs ,
Proposed Legislation ,
SAMHSA ,
Secretary of HHS ,
Trump Administration
On Feb. 9, 2018, the Trump Administration released a 30-page report analyzing domestic and global factors influencing drug pricing. The report by the Council of Economic Advisers (CEA) is expected to inform the HHS' Fiscal...more
2/13/2018
/ Antitrust Provisions ,
Biosimilars ,
Budget Reconciliation ,
Centers for Medicare & Medicaid Services (CMS) ,
Commodity Exchange Act (CEA) ,
Cross-Border Transactions ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Federal Budget ,
Fixed Price ,
Food and Drug Administration (FDA) ,
GAO ,
Health Care Providers ,
Incentives ,
Manufacturers ,
Medicaid ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
MedPAC ,
OIG ,
Outpatient Services ,
Pharmaceutical Industry ,
Physician Medicare Reimbursements ,
Prescription Drugs ,
Price-Fixing ,
Rebates ,
Secretary of HHS ,
Section 340B ,
Social Security Act ,
Supply Chain ,
Trump Administration
Congress moved one step closer to avoiding a government shutdown on Feb. 6, voting overwhelmingly (245-182) to pass a short-term, GOP-backed government funding bill (text; section-by-section) that would keep the federal...more
2/9/2018
/ 21st Century Cures Act ,
Affordable Care Act ,
Budget Cuts ,
Children's Health Insurance Program (CHIP) ,
Department of Defense (DOD) ,
Federal Budget ,
Federal Funding ,
Government Shutdown ,
Health Care Providers ,
Health Insurance ,
Healthcare Costs ,
Hospitals ,
IPAB ,
Legislative Agendas ,
Medicare ,
Medicare Access and CHIP Reauthorization (MACRA) ,
MIECHV Program ,
National Health Service Corp (NHSC) ,
National Institute of Health (NIH) ,
Offsets ,
Physicians ,
Public Health ,
Tax Extenders ,
Trump Administration
The Senate Health, Education, Labor, & Pensions (HELP) Committee held the first hearing on the confirmation for Secretary of Health and Human Services (HHS) nominee Alex Azar on Wednesday, November 29. Notably, only the...more
Below is a summary of recent U.S. Senate action on healthcare legislation and our outlook regarding coming issues and possible actions. Holland & Knight's Healthcare & Life Sciences Team will follow up as developments...more
8/3/2017
/ Affordable Care Act ,
Cost-Sharing ,
Disproportionate Share Adjustments ,
DSH ,
Health Insurance ,
Health Insurance Exchanges ,
Healthcare Reform ,
HELP ,
Individual Mandate ,
Legislative Agendas ,
Medicaid ,
Repeal ,
Trump Administration ,
Waivers
The U.S. House of Representatives narrowly passed H.R. 1628, the American Health Care Act (AHCA), by a vote of 217-213 on May 4, 2017, with all Democrats and 20 Republicans opposing the bill. The legislation traversed a...more
5/12/2017
/ Affordable Care Act ,
American Health Care Act (AHCA) ,
Employer Mandates ,
Essential Health Benefits ,
Federal Funding ,
Health Insurance ,
Medicaid ,
Medicaid Expansion ,
Planned Parenthood ,
Preexisting Conditions ,
Repeal ,
State Health Insurance Exchanges ,
Tax Credits ,
Trump Administration
Congressional Republican leaders have indicated that they will approach the repeal and replacement of the Affordable Care Act in three steps: 1) repeal and replace through the so-called "budget reconciliation" process; 2)...more
3/9/2017
/ Affordable Care Act ,
Employer Mandates ,
Health Insurance ,
Health Savings Accounts ,
Healthcare Reform ,
Individual Mandate ,
Medicaid ,
Proposed Legislation ,
Repeal ,
Tax Credits ,
Trump Administration