The Centers for Medicare & Medicaid Services (CMS) Center for Medicare and Medicaid Innovation (CMMI) (Innovation Center) has unveiled a series of new models related to the administration’s focus on improving the health of...more
Healthcare workforce shortages are critically impacting multiple healthcare professions and geographies, threatening access to care and straining existing providers. Pipeline challenges are being increasingly affected by...more
Health care is a consistently active area for policymakers on Capitol Hill. This alert highlights five health policy issues to watch as Congress returns from August recess. While the fiscal year 2026 (FY26) appropriations...more
In March 2020, Congress enacted the first Over-the-Counter (OTC) Monograph Drug User Fee program (OMUFA) as part of the CARES Act (P.L. 116 – 136) to modernize the Food and Drug Administration’s regulation of OTC monograph...more
Over 35 health care provisions were included in the One Big Beautiful Bill Act of 2025. These provisions span Medicaid, the Children’s Health Insurance Program (CHIP), the Affordable Care Act (ACA) marketplaces, Medicare and...more
On June 16, 2025, Senate Finance Committee Chairman Mike Crapo released text and a section-by-section summary of the Senate’s proposed One Big Beautiful Bill Act. The Senate passed a revised version of this measure on July 1,...more
7/7/2025
/ Budget Reconciliation ,
Congressional Budget Office ,
Federal Funding ,
Healthcare Reform ,
Medicaid ,
Medicare ,
Popular ,
Prescription Drugs ,
Senate Finance Committee ,
Tax Cuts and Jobs Act ,
Tax Reform ,
Trump Administration
In the final stretch of the Biden administration, the Food and Drug Administration (FDA) laid the groundwork for continued engagement with the public on two challenging areas of product development, each of which is of high...more
On January 6, the FDA announced the availability of draft guidance on accelerated approval for drugs and biological products, and consideration for determining whether a confirmatory trial is underway. Under the Consolidated...more
As the new year begins, change is afoot inside the Beltway as the 119th Congress gets underway and Washington prepares for President Trump’s second administration. While change is bringing uncertainty on some fronts, health...more
1/6/2025
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Consolidated Appropriations Act (CAA) ,
DEA ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Federal Funding ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Medicaid ,
Medicare ,
Over The Counter Drugs (OTC) ,
Pharmacy Benefit Manager (PBM) ,
Policies and Procedures ,
Trump Administration
With a historic election now behind us, the 118th Congress will return to work for a Lame Duck session to address must-pass items and for Senate Democrats to pass as many final judicial appointments as time and political will...more