The Centers for Medicare & Medicaid Services (CMS) recently issued a long-awaited Notice with Comment Period outlining a proposed Transitional Coverage for Emerging Technologies (TCET) pathway under Medicare that would be...more
7/14/2023
/ Administrative Procedure ,
Centers for Medicare & Medicaid Services (CMS) ,
Emerging Technologies ,
Expedited Approval Process ,
Food and Drug Administration (FDA) ,
MACs ,
Medical Devices ,
Medicare ,
New Guidance ,
Notice and Comment ,
Rulemaking Process
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
7/12/2023
/ 21st Century Cures Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Consumer Financial Protection Bureau (CFPB) ,
Department of Health and Human Services (HHS) ,
Guidance Update ,
Health Care Providers ,
Home Health Care ,
Inflation Reduction Act (IRA) ,
Information Blocking Rules ,
Legislative Agendas ,
Medical Bills ,
Medicare ,
No Surprises Act (NSA) ,
OIG ,
Physician Fee Schedule ,
Request For Information ,
Surprise Medical Bills
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
6/22/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Congressional Committees ,
Congressional Investigations & Hearings ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
MACPAC ,
Medicare ,
Medicare Part D ,
MedPAC ,
Pharmacy Benefit Manager (PBM) ,
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....more
6/16/2023
/ American Academy of Pediatrics ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Investigations & Hearings ,
Coronavirus/COVID-19 ,
Corporate Practice of Medicine ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Industry Consolidation ,
Physicians ,
Prescription Drugs ,
Request For Information ,
Supply Chain ,
Telehealth
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
6/7/2023
/ Biden Administration ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Congressional Investigations & Hearings ,
Coronavirus/COVID-19 ,
Health Care Providers ,
Healthcare Facilities ,
MedPAC ,
Prescription Drugs ,
Presidential Nominations ,
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.
...more
6/5/2023
/ CBO Report ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Congressional Investigations & Hearings ,
Health Care Providers ,
Health Insurance ,
Medicaid ,
Medicaid Drug Rebate Program ,
Pharmacy Benefit Manager (PBM) ,
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.
This week's topics include...more
5/25/2023
/ Biden Administration ,
Comment Period ,
Congressional Committees ,
Debt Ceiling ,
Federal Budget ,
Federal Trade Commission (FTC) ,
GAO ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach Notification Rule ,
Medicaid ,
Mental Health ,
PHI ,
Proposed Legislation ,
Section 340B ,
Telehealth
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
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
The Biden Administration announced on Jan. 30, 2023, its intent to end the COVID-19 Public Health Emergency (PHE) on May 11, 2023. Fortunately, the 2023 Consolidated Appropriations Act (CAA) extends certain key telehealth...more
5/2/2023
/ Biden Administration ,
CARES Act ,
Consolidated Appropriations Act (CAA) ,
Coronavirus/COVID-19 ,
DEA ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
HDHP ,
Health Care Providers ,
Health Insurance ,
Health Savings Accounts ,
Medicaid ,
Medicare ,
Public Health Emergency ,
Rural Health Care Providers ,
Telehealth
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
The Centers for Medicare & Medicaid Services (CMS or Agency) on April 10, 2023, published its annual proposed rule for the federal fiscal year (FY) 2024 Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital...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
3/30/2023
/ 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
3/9/2023
/ Biden Administration ,
Congressional Committees ,
Congressional Intent ,
Congressional Investigations & Hearings ,
Controlled Substances ,
DEA ,
Federal Budget ,
Health Care Providers ,
Healthcare Workers ,
Pharmacy Benefit Manager (PBM) ,
Proposed Rules ,
Public Meetings ,
Telehealth
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
3/1/2023
/ ACOs ,
BPCI ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Investigations & Hearings ,
Coronavirus/COVID-19 ,
DEA ,
Federal Budget ,
Health Care Providers ,
Healthcare Facilities ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Public Health Emergency ,
Telehealth
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
2/9/2023
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Investigations & Hearings ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Federal Budget ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medicaid ,
Medicare ,
New Guidance ,
Pending Legislation ,
Pharmacies ,
Public Health Emergency ,
Section 340B ,
State of the Union
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
Lawmakers unveiled their long-awaited $1.7 trillion government funding package on Dec. 20, 2022. As of publishing, it seems likely that a vote on final passage in the U.S. Senate will occur at some point on Dec. 22, with a...more
12/22/2022
/ Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Infectious Diseases ,
Medicare ,
Mental Health ,
National Institute of Health (NIH) ,
Prescription Drugs ,
Public Health ,
SAMHSA