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. Food and Drug Administration (FDA) recently announced its plan to provide medical device manufacturers 180 days to secure marketing authorization or clearance for medical devices that have been marketed under special...more
The Centers for Disease Control and Prevention (CDC) reports that as of Jan. 8, 2021, about 6.7 million people have received at least one dose of a COVID-19 vaccine, far short of the prediction by the Trump Administration of...more
1/12/2021
/ Biden Administration ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Emergency Response ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
Moderna Inc. ,
National Institute of Health (NIH) ,
Operation Warp Speed ,
Pfizer ,
Public Health Emergency ,
State and Local Government ,
Vaccinations
Since March 2020, and in some cases before, the U.S. government, Congress and external entities have worked to design plans to reduce the impact of COVID-19 and ultimately prepare for the development and distribution of a...more
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
In struggling to address the evolving COVID-19 pandemic, the United States and many other countries continue to face major shortages of Personal Protective Equipment (PPE), such as N95 masks, gowns and other vital materials...more
8/3/2020
/ Bank Secrecy Act ,
Coronavirus/COVID-19 ,
Customs and Border Protection ,
Department of Justice (DOJ) ,
Enforcement Actions ,
FinCEN ,
Fraud ,
Imports ,
Medical Devices ,
Medical Supplies ,
Personal Protective Equipment ,
Price Gouging ,
Scams ,
Supply Chain
Issues relating to liability for pharmaceutical, personal protective equipment (PPE) and diagnostic test businesses as well as for physicians and healthcare personnel in the coronavirus (COVID-19) context remains a salient...more
In response to the COVID-19 pandemic and the need for more diagnostic testing, the U.S. Food and Drug Administration (FDA) has developed several pathways for manufacturers and developers of COVID-19 diagnostic tests to...more
The COVID-19 crisis has revealed the extent to which the United States and other countries are dependent upon a well-functioning global supply chain of critical medical supplies, including ventilators and Personal Protective...more
The widely reported shortages of Personal Protective Equipment (PPE), including masks and gowns, across the United States have led to the importation, distribution and use of PPE manufactured overseas. In particular, many...more
The U.S. Food and Drug Administration (FDA) has issued several final guidance documents to assist manufacturers developing medical products in response to the coronavirus (COVID-19) pandemic. While some are published as...more
The U.S. Food and Drug Administration (FDA) has issued a new guidance for novel coronavirus (COVID-19) molecular diagnostics tests developed and used in certain laboratories. The guidance, issued on Feb. 29, 2020, is designed...more