Washington, D.C. is currently focused on a September continuing resolution (CR) to keep the federal government funded, but it is worth looking ahead to the broader health care horizon and the key Medicare issues that await...more
9/19/2022
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Health Care Providers ,
Inflation Reduction Act (IRA) ,
Lame Duck Session ,
Legislative Agendas ,
Medicare ,
Mental Health ,
Substance Abuse ,
Telehealth ,
Telemedicine
For the past two years, the United States government has had to deal with most major legislative and regulatory actions against the backdrop of the COVID-19 pandemic. In making policy, the federal government has been forced,...more
For several years, policy-makers and commentators have expressed concern about the resilience of the United States’ pharmaceutical supply chain. Current U.S.-based manufacturing capabilities have been at the forefront of...more
10/8/2021
/ Biden Administration ,
Biomedical Advanced Research and Development Authority (BARDA) ,
China ,
Competition ,
Coronavirus/COVID-19 ,
Defense Production Act ,
Department of Defense (DOD) ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Manufacturers ,
NDAA ,
Pharmaceutical Industry ,
Supply Chain
Key Points -
The recent announcements around federal contractor requirements for mandatory vaccination and the upcoming OSHA Emergent Temporary Standard have created significant confusion for employers.
It’s important...more
10/1/2021
/ Biden Administration ,
Coronavirus/COVID-19 ,
Department of Labor (DOL) ,
Employer Mandates ,
Executive Orders ,
Federal Contractors ,
Federal Employees ,
Infectious Diseases ,
OSHA ,
Vaccinations ,
Workplace Safety
Background on Cures 2.0 -
The COVID-19 pandemic response demonstrated the tremendous impact innovation can have on a global scale. The unprecedented experiences of the past year and a half have spurred renewed interest in...more
Key Points
- Congress and government watchdogs have conducted considerable work to date investigating the COVID-19 response pertaining to nursing homes.
- Stakeholders should look to previously introduced...more
On February 17, 2021, it was reported that President Biden would nominate Chiquita Brooks-LaSure as Administrator of the Centers for Medicare & Medicaid Services (CMS), the largest operating division of the U.S. Department of...more
On February 12, the U.S. Centers for Disease Control and Prevention (CDC) released highly anticipated guidelines for school reopening during the pandemic. Whereas administrators, teachers and parents were hoping for very...more
On January 28, 2021, President Biden issued an Executive Order on Strengthening Medicaid and the Affordable Care Act, responsive to Democrats’ longstanding commitment to “roll back Trump’s health care sabotage [of the...more
The Biden administration announced on Tuesday, January 26 that it plans to purchase 200 million additional doses of vaccine against COVID-19. Additionally, the administration announced that it plans to increase shipments of...more
On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more
8/13/2020
/ Best Practices ,
Coronavirus/COVID-19 ,
Counterfeiting ,
Department of Defense (DOD) ,
Department of Health and Human Services (HHS) ,
Department of Homeland Security (DHS) ,
E-Commerce ,
Executive Orders ,
Exemptions ,
Food and Drug Administration (FDA) ,
Free Trade Agreements ,
Health and Safety ,
Imports ,
Infectious Diseases ,
Manufacturers ,
Medical Supplies ,
OMB ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Prescription Drugs ,
Procurement Guidelines ,
Public Health ,
Reporting Requirements ,
Section 301 ,
Supply Chain ,
Trump Administration ,
Waivers ,
WTO
- Legislation to bolster the U.S. supply chain for medical equipment becomes an issue of bipartisan focus in Congress.
- Differing proposals included in the House and Senate “Phase 4” COVID-relief proposals as well...more
8/5/2020
/ Acquisitions ,
Coronavirus/COVID-19 ,
Manufacturers ,
Medical Equipment ,
Medical Supplies ,
Onshoring ,
Personal Protective Equipment ,
Proposed Legislation ,
Relief Measures ,
Supply Chain ,
Tax Credits
With Introduction of HEALS Act, Bipartisan Negotiations on Phase 4 Begin in Earnest: An Analysis of the House and Senate Positions -
Senate Republicans on Monday unveiled their next COVID-19 response legislation in the...more
7/29/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Economic Downturn ,
Federal Funding ,
Financial Stimulus ,
Legislative Agendas ,
Paycheck Protection Program (PPP) ,
Proposed Legislation ,
Relief Measures ,
School Districts ,
Unemployment Benefits ,
Virus Testing
Leaders of Small Business Committee Reach Consensus on Bill to Extend PPP Loan Deadline, Senate Fails to Clear Measure by Unanimous Consent as Phase 4 Negotiations Likely to Dominate June -
Bipartisan leaders of the Senate...more
5/26/2020
/ Agricultural Sector ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Department of Agriculture ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Farm Workers ,
Farms ,
Federal Funding ,
Federal Reserve ,
Filing Deadlines ,
Food and Drug Administration (FDA) ,
Health and Safety ,
Infectious Diseases ,
Legislative Agendas ,
Paycheck Protection Program (PPP) ,
Public Health ,
Re-Opening Guidelines ,
Relief Measures ,
SBA ,
Small Business ,
Small Business Loans ,
Supply Chain ,
Trump Administration ,
USDA
House Democrats Unveil Phase 4 Proposal – the HEROES Act -
House Democrats today unveiled H.R. 6800, the Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act. The approximately $3 trillion proposal, which...more
5/13/2020
/ Coronavirus/COVID-19 ,
Federal Funding ,
Financial Stimulus ,
Health and Safety ,
Infectious Diseases ,
Legislative Agendas ,
Liability ,
Proposed Legislation ,
Public Health ,
Re-Opening Guidelines ,
Relief Measures ,
Trump Administration ,
Virus Testing
Senate Elevates Bipartisan Calls for Revisions to Paycheck Protection Program -
This week Senate Republicans and Democrats have underscored the need for a number of changes to the Paycheck Protection Program (PPP)...more
5/8/2020
/ CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Federal Reserve ,
Financial Stimulus ,
Health and Safety ,
Infectious Diseases ,
Legislative Agendas ,
Loan Forgiveness ,
Paycheck Protection Program (PPP) ,
Public Health ,
Re-Opening Guidelines ,
Relief Measures ,
SBA ,
Small Business ,
U.S. Treasury
Federal Reserve Board Announces Expanded Scope and Eligibility for the Main Street Lending Program -
The Federal Reserve Board unveiled plans yesterday to expand the scope and eligibility for the Main Street Lending...more
5/1/2020
/ CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Federal Reserve ,
Financial Stimulus ,
Health and Safety ,
Legislative Agendas ,
Main Street Lending Programs ,
New Guidance ,
Re-Opening Guidelines ,
Relief Measures ,
SBA ,
Trump Administration ,
Unemployment Benefits
White House Unveils Testing Blueprint, Senate Slated to Return Monday, House Return Uncertain -
President Trump unveiled the Administration’s blueprint for state testing plans and rapid response programs on Monday,...more
4/29/2020
/ Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Federal Reserve ,
Food and Drug Administration (FDA) ,
Health and Safety ,
Legislative Agendas ,
Paycheck Protection Program (PPP) ,
Public Health ,
Re-Opening Guidelines ,
Relief Measures ,
State of Emergency ,
Trump Administration
House Passes $484 Billion Relief Package -
Today, the House of Representatives passed a $484 billion economic relief package in response to the Coronavirus pandemic, the Paycheck Protection Program and Health Care...more
4/24/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
FDIC ,
Financial Stimulus ,
Health and Safety ,
New Legislation ,
Paycheck Protection Program (PPP) ,
Public Health ,
Relief Measures ,
State and Local Government ,
Trump Administration ,
U.S. Treasury
Congress, Administration Reach $484 Billion Deal for Phase 3.5 -
Yesterday, congressional Democrats and Republicans reached a $484 billion deal with the Trump Administration for “Phase 3.5” of the coronavirus response to,...more
4/22/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Financial Stimulus ,
Food and Drug Administration (FDA) ,
Health and Safety ,
Legislative Agendas ,
Medical Testing ,
Paycheck Protection Program (PPP) ,
Public Health ,
Relief Measures ,
State and Local Government ,
Trump Administration ,
U.S. Treasury
President Trump Unveils Framework for “Opening Up America Again” -
President Trump yesterday provided recommendations to governors for reopening parts of the U.S. economy. The guidance, dubbed “Opening Up America Again,”...more
4/17/2020
/ CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Federal Reserve ,
Food and Drug Administration (FDA) ,
Legislative Agendas ,
Public Health ,
Relief Measures ,
Trump Administration ,
U.S. Treasury
Congress Fails to Reach Agreement on Additional Dollars for Small Business and Hospitals; Agencies Act to Provide CARES Act Funding to Key Sectors -
Congressional negotiators failed to reach agreement yesterday on adding...more
4/14/2020
/ CARES Act ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Federal Loans ,
Federal Reserve ,
Hospitals ,
Main Street Lending Programs ,
Relief Measures ,
Small Business ,
State and Local Government ,
U.S. Treasury
Congress, Administration Call for Additional Emergency Coronavirus Relief – Differences Remain -
In coordination with congressional Republican leadership (and with little advance notice to their Democratic counterparts),...more
4/13/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Economic Injury Disaster Loans ,
Federal Loans ,
Financial Stimulus ,
Paycheck Protection Program (PPP) ,
Relief Measures ,
SBA ,
SBA Lending Programs ,
Small Business ,
Trump Administration
Pelosi and McConnell Both Look to Bipartisan Phase 4 Legislation -
Congress now likely remains adjourned until April 20 for the safety of both members and congressional staff, but discussions have already begun on a Phase...more
4/9/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Department of Energy (DOE) ,
Energy Sector ,
Financial Stimulus ,
Infectious Diseases ,
Interim Final Rules (IFR) ,
Legislative Agendas ,
Oil & Gas ,
Paycheck Protection Program (PPP) ,
Petroleum ,
Public Health ,
Relief Measures ,
SBA ,
Small Business
While the United States now leads the world with the number of reported cases of COVID-19, the Coronavirus Aid, Relief, and Economic Security (CARES) Act (or “the Act”) takes major, though perhaps still incomplete, steps...more
4/1/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Financial Stimulus ,
Health Care Providers ,
Hospitals ,
Medical Devices ,
Medical Supplies ,
Medical Testing ,
Over The Counter Drugs (OTC) ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Relief Measures