The U.S. Supreme Court issued a significant ruling on June 28, 2024, that changes the respective roles of administrative agencies and the courts in interpreting statutes. In Loper Bright Enterprises v. Raimondo, the court...more
7/5/2024
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Health Care Providers ,
Loper Bright Enterprises v Raimondo ,
OCR ,
Regulatory Authority ,
SCOTUS ,
Statutory Interpretation
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
11/30/2023
/ Artificial Intelligence ,
Biden Administration ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Investigations & Hearings ,
Continuing Resolution ,
Defense Production Act ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Medicare ,
Medicare Advantage ,
NDAA ,
Physician Fee Schedule ,
Physicians ,
Retirement ,
Supply Chain
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
President Joe Biden on Oct. 30, 2023, signed a sweeping executive order (EO) and invoked the Defense Production Act to establish the first set of standards for using artificial intelligence (AI) in healthcare and other...more
11/7/2023
/ Artificial Intelligence ,
Biden Administration ,
Compliance ,
Compliance Dates ,
Defense Production Act ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Federal Funding ,
Health Care Providers ,
Innovation ,
Innovative Technology ,
Legislative Agendas ,
Medical Research ,
NIST ,
Payment Systems ,
Pharmaceutical Industry ,
Popular ,
Regulatory Agenda ,
Regulatory Oversight ,
Risk Management ,
Scientific Research ,
USPTO
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
10/26/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicare ,
Mental Health ,
Outpatient Prospective Payment System (OPPS) ,
Physician Fee Schedule ,
Physician Medicare Reimbursements ,
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
10/18/2023
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Investigations & Hearings ,
Deductibles ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Hospitals ,
Information Reports ,
Medicare ,
Medicare Part A ,
Medicare Part B ,
National Institute of Health (NIH) ,
Nonprofits ,
Outpatient Prospective Payment System (OPPS) ,
Pfizer ,
Physician Fee Schedule ,
Premiums ,
Presidential Nominations ,
Public Policy ,
Section 340B ,
Speaker of the House
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
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
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
6/16/2023
/ 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.
This week's topics include...more
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 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
2/9/2023
/ 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
1/19/2023
/ 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
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
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
12/1/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Dispute Resolution ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Infectious Diseases ,
Medicaid ,
Medicare ,
Pending Legislation ,
Proposed Rules ,
Section 340B ,
Substance Abuse ,
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
11/23/2022
/ Artificial Intelligence ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Election Results ,
Health Care Providers ,
Legislative Agendas ,
Medicaid ,
Medicare ,
Medicare Advantage ,
Public Health Emergency ,
Surprise Medical Bills ,
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.
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.
...more
10/19/2022
/ Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Inflation Reduction Act (IRA) ,
Medicare ,
Prescription Drugs ,
Public Health Emergency ,
Section 340B ,
Vaccinations
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.
This...more
9/26/2022
/ Biden Administration ,
CARES Act ,
Congressional Committees ,
Continuing Resolution ,
Conversion ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Federal Budget ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hurricane Season ,
Medicare ,
Medicare Advantage ,
Mental Health ,
Proposed Legislation ,
Puerto Rico ,
Surprise Medical Bills ,
Telehealth
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