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
12/7/2022
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Continuing Resolution ,
Dispute Resolution ,
Health Care Providers ,
Legislative Agendas ,
Medicaid ,
Medicare ,
Mental Health ,
Prescription Drugs ,
Proposed Legislation ,
Section 340B
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
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
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
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 U.S. Departments of Health and Human Services (HHS), Labor and Treasury, along with the Office of Personnel Management, on July 1, 2021, issued a much-anticipated Interim Final Rule with Comment Period (IFC) –...more
7/6/2021
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Consolidated Appropriations Act (CAA) ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Disclosure Requirements ,
Dispute Resolution ,
Emergency Rooms ,
Employee Retirement Income Security Act (ERISA) ,
Employer Group Health Plans ,
Health Care Providers ,
Health Insurance ,
Healthcare Facilities ,
Interim Final Rules (IFR) ,
OPM ,
Out of Network Provider ,
Surprise Medical Bills ,
U.S. Treasury
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 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
A presidential race called by media outlets for former Vice President Joe Biden, coupled with a diminished Democratic majority in the U.S. House of Representatives and a narrowly divided Senate, translates into a federal...more
11/12/2020
/ Affordable Care Act ,
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) ,
Federal Budget ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Judicial Appointments ,
Legislative Agendas ,
Presidential Elections ,
Public Policy ,
Regulatory Agenda
Under Section 1557 of the Affordable Care Act (Section 1557), "covered entities," which were defined as health programs or activities that receive "federal funding" from the U.S. Department of Health and Human Services (HHS)...more
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 Monday, the Centers for Medicare & Medicaid Services (CMS) and the Department of Treasury released guidance relaxing a range of requirements for state waivers submitted under Section 1332 of the Affordable Care Act (ACA)....more
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
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
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
U.S. Senate Republicans on June 22, 2017, unveiled a "discussion draft" of their healthcare plan, the Better Care Reconciliation Act. This memorandum provides highlights of key provisions.
The Congressional Budget Office...more
6/27/2017
/ Affordable Care Act ,
Block Grants ,
Cadillac Tax ,
Congressional Budget Office ,
Disproportionate Share Adjustments ,
Employer Mandates ,
Health Insurance ,
Healthcare Reform ,
Individual Mandate ,
Legislative Agendas ,
Medicaid ,
Medicaid Expansion ,
Popular ,
Proposed Legislation ,
Repeal ,
Stabilization Issues ,
Tax Credits
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
The Centers for Medicare & Medicaid Services (CMS) on Oct. 14, 2016, released the highly anticipated Final Rule implementing the Medicare physician payment reforms enacted as part of the Medicare Access and CHIP...more
10/20/2016
/ ACOs ,
Affordable Care Act ,
Alternative Payment Models (APM) ,
Centers for Medicare & Medicaid Services (CMS) ,
Electronic Health Record Incentives ,
Health Care Providers ,
Healthcare ,
Medicaid ,
Medicare ,
Medicare Access and CHIP Reauthorization (MACRA) ,
MIPS ,
Nurse Practitioners ,
Physician Assistants ,
Physician Medicare Reimbursements ,
Physicians ,
PQRS ,
Quality Payment Program (QPP) ,
Sustainable Growth Rate (SGR) ,
Value-Based Payments
On Nov. 7, 2014, the U.S. Supreme Court announced that it will hear the case of King v. Burwell, one of multiple challenges to the validity of the premium tax credits provided under the Affordable Care Act (ACA) to...more
The U.S. Court of Appeals for the D.C. Circuit ruled, in a 2-to-1 decision, in Halbig v. Burwell that the IRS is not authorized under the Affordable Care Act (ACA) to provide tax credits intended to subsidize the cost of...more