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.
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
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
10/5/2022
/ Biden Administration ,
CBO Report ,
Centers for Medicare & Medicaid Services (CMS) ,
Commercial Insurance Policies ,
Continuing Resolution ,
FDA Approval ,
Federal Budget ,
FEMA ,
Food and Drug Administration (FDA) ,
Government Shutdown ,
Health Clinics ,
Medicaid ,
Medicare Part A ,
Medicare Part B ,
Premiums ,
Prescription Drugs ,
Public Health ,
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
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
8/3/2022
/ Appropriations Bill ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Final Rules ,
Health Care Providers ,
Medicaid ,
Medicare Part D ,
Nursing Homes ,
Proposed Legislation ,
Public Health Emergency ,
Telehealth
As Congress reconvenes, it faces a packed agenda in a legislative year that will be shortened by the upcoming midterm elections and remains buffeted by the persistent coronavirus pandemic. The list of healthcare priorities is...more
1/7/2022
/ Affordable Care Act ,
Appropriations Bill ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Coronavirus/COVID-19 ,
Data Collection ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Federal Budget ,
Graduate Medical Education ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Industry Consolidation ,
Legislative Agendas ,
Medicaid ,
Medicare ,
National Institute of Health (NIH) ,
NDAA ,
Proposed Legislation ,
Public Health ,
Public Health Emergency ,
Surprise Medical Bills ,
Telehealth ,
Water Resources Development Act
The Centers for Medicare & Medicaid Services (CMS) has released the Final Rule with a comment period for the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; Changes to Medicare Graduate Medical...more
12/21/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Consolidated Appropriations Act (CAA) ,
Final Rules ,
FTEs ,
Graduate Medical Education ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
HRSA ,
Inpatient Prospective Payment System (IPPS) ,
Medicaid ,
Medicare ,
Organ Donation ,
Rural Health Care Providers
The Centers for Medicare & Medicaid Services (CMS) on Nov. 4, 2021, issued a long-anticipated Interim Final Rule with comment (IFC) requiring COVID-19 vaccination for most healthcare workers at certain healthcare facilities...more
11/9/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Covered Employer ,
Enforcement ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Workers ,
Interim Final Rules (IFR) ,
Medicaid ,
Medicare ,
OSHA ,
Preemption ,
Supremacy Clause ,
Vaccinations
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
The Centers for Medicare & Medicaid Services (CMS) on April 27, 2021, released the Fiscal Year (FY) 2022 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH) Prospective Payment...more
5/5/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Graduate Medical Education ,
Health Care Providers ,
Hospitals ,
Inpatient Prospective Payment System (IPPS) ,
Long Term Care Facilities ,
Medicaid ,
Medicare ,
Medicare Shared Savings Program ,
Proposed Rules ,
Quality of Care Standards ,
Reporting Requirements ,
Rural Health Care Providers
The U.S. House of Representatives on March 10, 2021, passed the Senate-amended H.R. 1319, the American Rescue Plan (ARP). The ARP provides $1.9 trillion in additional relief to respond to the novel coronavirus (COVID-19)....more
3/11/2021
/ Agricultural Sector ,
American Rescue Plan Act of 2021 ,
Biden Administration ,
Broadband ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Defense Production Act ,
Economic Injury Disaster Loans ,
Economic Stimulus ,
Medicaid ,
Medicare ,
Native American Issues ,
Paycheck Protection Program (PPP) ,
Pending Legislation ,
Popular ,
Public Health ,
Public Schools ,
Relief Measures ,
Residential Leases ,
Residential Property Owners ,
Restaurant Industry ,
Rural Health Care Providers ,
Small Business ,
SNAP Program ,
State and Local Government ,
Tax Credits ,
Transportation Industry ,
Unemployment Benefits ,
Vaccinations ,
Virus Testing
On his first days in office, President Joe Biden is expected to sign a flurry of executive actions, some of which will reverse decisions made by his predecessor, President Donald Trump. The first few Biden Administration...more
1/26/2021
/ Affordable Care Act ,
Biden Administration ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Emergency Management Plans ,
Executive Orders ,
Federal Contractors ,
Federal Land ,
Masks ,
Medicaid ,
Race Relations ,
Regulatory Requirements ,
World Health Organization
The victories by Democrats Raphael Warnock and Jon Ossoff in the Georgia elections mean that incoming majority leader Chuck Schumer (D-N.Y.) will preside over the narrowest possible majority in the U.S. Senate under which...more
1/20/2021
/ Administrative Procedure Act ,
Affordable Care Act ,
Antitrust Provisions ,
Biden Administration ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Legislative Agendas ,
Medicaid ,
Medicare ,
Most-Favored Nations ,
Physician Fee Schedule ,
Political Parties ,
Regulatory Agenda ,
Tax Cuts and Jobs Act
The Centers for Medicare & Medicaid Services (CMS) has published the Calendar Year (CY) 2021 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule. Note that the...more
12/9/2020
/ Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratories ,
Coronavirus/COVID-19 ,
Final Rules ,
Health Care Providers ,
Hospitals ,
Medicaid ,
Medicare ,
Outpatient Prospective Payment System (OPPS) ,
Physician-Owned Hospitals ,
Prescription Drugs
On March 6, Congress passed the Coronavirus Supplemental Appropriations Act (H.R. 6074), which included a $500 million authorization to enhance telehealth services. The legislation gives the U.S. Department of Health and...more
3/25/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Emergency Response ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicaid ,
Medicare ,
OIG ,
Relief Measures ,
Telehealth ,
Telemedicine
The Centers for Medicare & Medicaid Services (CMS) released a State Medicaid Director (SMD) letter and fact sheet on Jan. 30, 2020, that encouraged states to pursue block grant or per capita cap funding through their Medicaid...more
On August 2, 2019, the Centers for Medicare and Medicaid Services (CMS) released the Fiscal Year (FY) 2020 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital Prospective Payment System...more
8/9/2019
/ Applications ,
Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
Health Care Providers ,
Hospitals ,
Inpatient Prospective Payment System (IPPS) ,
Inpatient Quality Reporting ,
Long Term Care Facilities ,
Medicaid ,
Medicare ,
Payment Systems ,
Proposed Rules ,
Public Comment ,
Rulemaking Process ,
Value-Based Purchasing ,
Wage Index
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
Enforcement -
OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor -
On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more
5/30/2018
/ Adverse Action ,
Advisory Opinions ,
Affordable Care Act ,
Anti-Kickback Statute ,
Antitrust Litigation ,
Beneficiaries ,
Biosimilars ,
CMMI ,
Competition ,
Constructive Discharge ,
Department of Health and Human Services (HHS) ,
Distributors ,
Drug Pricing ,
Employer Liability Issues ,
Enforcement ,
Failure To State A Claim ,
False Claims Act (FCA) ,
FDCPA ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Fraud ,
Hospitals ,
Kickbacks ,
Manufacturers ,
Medicaid ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
OIG ,
Patients ,
Pharmaceutical Industry ,
Pharmacies ,
Request For Information ,
Section 340B ,
Sherman Act ,
Statute of Limitations
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
The Centers for Medicare & Medicaid Services (CMS) on Nov. 1, 2017, released the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) Payment System Final Rule for...more
11/13/2017
/ ADLT ,
Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
Hospitals ,
Laboratories ,
Medicaid ,
Medicare ,
Medicare Access and CHIP Reauthorization (MACRA) ,
Medicare Part B ,
MPFS ,
Outpatient Prospective Payment System (OPPS) ,
Payment Rates ,
Physicians ,
Policies and Procedures ,
Prescription Drugs ,
Quality Payment Program (QPP)