Following the announcement that four Center for Medicare and Medicaid Innovation (CMMI or Innovation Center) models will end in 2025, the Centers for Medicare & Medicaid Services (CMS) has begun signaling what's next for the...more
5/20/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Drug Pricing ,
Healthcare Reform ,
Innovation ,
Medicaid ,
Medicare ,
Medicare Advantage ,
Physicians ,
Risk Management ,
Value-Based Care
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) released on April 4, 2025, the final rule for contract year (CY) 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit...more
4/14/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
ESRD ,
Final Rules ,
Health Care Providers ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Medicare ,
Medicare Advantage ,
Medicare Part D ,
Prescription Drugs ,
Regulatory Requirements
The Centers for Medicare & Medicaid Services (CMS) on Sept. 20, 2024, released the Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program (CMS-2434) Final Rule....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
12/15/2023
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Cybersecurity ,
Drug Pricing ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Interim Final Rules (IFR) ,
Medicaid ,
Medicare ,
Medicare Part B ,
MedPAC ,
OMB ,
Pending Legislation ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Private Equity ,
Private Equity Firms ,
Resignation ,
Transparency
The Centers for Medicare & Medicaid Services (CMS) released a final rule on Nov. 2, 2023, detailing how the agency will remedy underpayments from 2018 to 2022 for drugs acquired via the 340B Drug Pricing Program. The final...more
11/13/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Final Rules ,
Hospitals ,
Medicare ,
MedPAC ,
Outpatient Prospective Payment System (OPPS) ,
Prescription Drugs ,
Section 340B ,
Underpayment
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
10/4/2023
/ Appropriations Bill ,
Biden Administration ,
CBO Report ,
Centers for Disease Control and Prevention (CDC) ,
CMMI ,
Congressional Committees ,
Continuing Resolution ,
Drug Pricing ,
Federal Budget ,
HSA ,
Legislative Agendas ,
Managed Care Contracts ,
Medicaid ,
Medicare ,
National Institute of Health (NIH) ,
Pharmacy Benefit Manager (PBM) ,
Reporting Requirements ,
Request For Information
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
9/14/2023
/ Anti-Discrimination Policies ,
Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Congressional Investigations & Hearings ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Federal Budget ,
Health Care Providers ,
Information Reports ,
Long Term Care Facilities ,
Medicaid ,
Medicare ,
Medicare Part B ,
Nurses ,
Pharmacy Benefit Manager (PBM) ,
PHI ,
Prescription Drugs ,
Proposed Rules ,
Transparency
The Centers for Medicare & Medicaid Services (CMS) released the Hospital Outpatient Prospective Payment System: Remedy for 340B-Acquired Drugs Purchased in Cost Years 2018-2022 Proposed Rule on July 7, 2023. CMS has published...more
7/12/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Hospitals ,
Medicare ,
MedPAC ,
Outpatient Prospective Payment System (OPPS) ,
Prescription Drugs ,
Proposed Rules ,
Public Health Service Act ,
Section 340B
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
5/19/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Congressional Committees ,
Coronavirus/COVID-19 ,
Debt Ceiling ,
Drug Pricing ,
Federal Budget ,
GAO ,
Generic Drugs ,
Medicaid ,
Medicare ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Legislation ,
Public Health Emergency ,
Section 340B
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
5/4/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Congressional Committees ,
Congressional Investigations & Hearings ,
Drug Pricing ,
Health Care Providers ,
Hospitals ,
Inflation Reduction Act (IRA) ,
Medicaid ,
Prescription Drugs ,
Proposed Legislation ,
Tax Exempt Entities ,
Transparency
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...more
4/24/2023
/ Artificial Intelligence ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Inpatient Prospective Payment System (IPPS) ,
National Cancer Moonshot ,
Physician Fee Schedule ,
Prescription Drugs ,
Proposed Legislation ,
Public Health Emergency
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
3/30/2023
/ Biden Administration ,
Center for Biologics Evaluation and Research (CBER) ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Congressional Committees ,
Congressional Investigations & Hearings ,
Coronavirus/COVID-19 ,
Drug Pricing ,
Families First Coronavirus Response Act (FFCRA) ,
Health Care Providers ,
HRSA ,
Medicaid ,
Organ Transplant Centers ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Public Health Emergency ,
Public Policy ,
Secretary of HHS
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
3/22/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Medicare ,
Medicare Advantage ,
MedPAC ,
National Security ,
New Guidance ,
Prescription Drugs
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
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
2/2/2023
/ Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Legislative Agendas ,
MACPAC ,
Medicare ,
Medicare Advantage ,
Prescription Drugs ,
Public Health Emergency
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
1/26/2023
/ ACOs ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Congressional Committees ,
Congressional Oversight ,
Coronavirus/COVID-19 ,
Drug Pricing ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medicare Shared Savings Program ,
National Institute of Health (NIH) ,
Prescription Drugs
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
1/19/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Graduate Medical Education ,
Health Care Providers ,
MACPAC ,
Medicaid ,
Medicare ,
Medicare Part D ,
MedPAC ,
Public Health Emergency
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
10/12/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Drug Pricing ,
Health Care Providers ,
Inflation Reduction Act (IRA) ,
Medicaid ,
Medical Devices ,
Medicare ,
Medicare Part D ,
Physician Fee Schedule ,
Physicians ,
Prescription Drug Coverage ,
Prescription Drugs ,
Proposed Legislation
Congress ended a busy work period after passing the Inflation Reduction Act (IRA) last week. This Holland & Knight alert summarizes the healthcare provisions in the IRA and provides an outlook on health policy issues that may...more
8/17/2022
/ Affordable Care Act ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Infectious Diseases ,
Inflation Reduction Act (IRA) ,
Medicaid ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Mental Health ,
Mental Health Parity Rule ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Public Health Emergency ,
Tax Credits ,
Telehealth ,
Vaccinations
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
8/10/2022
/ Abortion ,
Biden Administration ,
Coronavirus/COVID-19 ,
Drug Pricing ,
Health Care Providers ,
Infectious Diseases ,
Medicare ,
Prescription Drugs ,
Proposed Legislation ,
Public Health Emergency ,
Reproductive Healthcare Issues ,
Veterans ,
Veterans' Benefits
The U.S. Senate on Aug. 7, 2022, passed the Inflation Reduction Act of 2022 (IRA). This comprehensive legislation is the result of many months of negotiations among Democrats to advance some of President Joe Biden's highest...more
8/8/2022
/ Administrative Agencies ,
Administrative Authority ,
Affordable Care Act ,
Biden Administration ,
Budget Reconciliation ,
Clean Energy ,
Climate Change ,
Corporate Counsel ,
Drug Pricing ,
Electric Vehicles ,
Energy Efficiency ,
Energy Sector ,
Environmental Policies ,
Federal Budget ,
Internal Revenue Code (IRC) ,
Medicare ,
Medicare Part D ,
Pending Legislation ,
Popular ,
Prescription Drugs ,
Regulatory Agencies ,
Renewable Energy ,
Superfund ,
Tax Incentives ,
Tax Revenues ,
Zero-Emission Vehicles
The Centers for Medicare & Medicaid Services (CMS) has released the calendar year (CY) 2023 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule (CMS-1772-P),...more
7/21/2022
/ Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Drug Pricing ,
Health Care Providers ,
Hospitals ,
Inpatient Prospective Payment System (IPPS) ,
Medicare ,
Mental Health ,
Opioid ,
Organ Donation ,
Outpatient Prospective Payment System (OPPS) ,
Prescription Drugs ,
Proposed Rules ,
Rural Health Care Providers ,
Section 340B
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
7/20/2022
/ Abortion ,
Affordable Care Act ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Dobbs v. Jackson Women’s Health Organization ,
Drug Pricing ,
Outpatient Prospective Payment System (OPPS) ,
Public Health Emergency ,
Reproductive Healthcare Issues ,
User Fees
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
6/15/2022
/ Department of Health and Human Services (HHS) ,
Drug Pricing ,
Failure To Disclose ,
Federal Trade Commission (FTC) ,
Fines ,
Gun Laws ,
Health Care Providers ,
Hospitals ,
Pending Legislation ,
Pharmacy Benefit Manager (PBM) ,
Price Transparency ,
User Fees