The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more
4/25/2024
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Review Act ,
Department of Health and Human Services (HHS) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
GAO ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
HRSA ,
Laboratory Developed Tests ,
Medicaid ,
Medicare ,
NIST ,
Nursing Homes ,
OIG ,
OIRA ,
OMB ,
Payment Systems ,
PHI ,
Policies and Procedures ,
Prescription Drugs ,
Presidential Elections ,
Proposed Guidance ,
Regulatory Agenda ,
Regulatory Standards ,
Rulemaking Process
Congress is taking a closer look at business practices in the health care sector and considering bipartisan reforms in light of increasing consolidation and its perceived affects on patient access and affordability. Various...more
The Inflation Reduction Act (IRA), P.L. 117-169, which became law on August 16th, included some of the most consequential prescription drug pricing reforms ever passed by Congress. This week marked a pivotal milestone in the...more
As has been widely reported, earlier this summer, President Biden issued Executive Order (EO) 14036, “Promoting Competition in the American Economy.” The EO provides insight into how the Biden-Harris administration plans to...more
9/10/2021
/ Biden Administration ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Competition ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Healthcare Reform ,
Hospitals ,
Life Sciences ,
Pharmaceutical Industry
President-elect Biden’s agenda and approach for his first 100 days in office will depend to a large degree on which party controls the United States Senate. Many of the incoming President’s major campaign promises—such as...more
11/24/2020
/ Affordable Care Act ,
Biden Administration ,
Cole Memorandum ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Healthcare Reform ,
Legislative Agendas ,
Medicaid ,
Medicare ,
Opioid ,
Public Policy ,
Regulatory Agenda