Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more
8/12/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Healthcare Reform ,
HRSA ,
Inflation Reduction Act (IRA) ,
Life Sciences ,
Medicaid Drug Rebate Program ,
Medicare Advantage ,
Pharmaceutical Industry ,
Section 340B ,
Trump Administration
On July 4, 2025, President Trump signed into law the One Big Beautiful Bill Act, his signature policy legislation. Two aspects of this legislation are particularly relevant for drug pricing....more
7/15/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
HRSA ,
Inflation Reduction Act (IRA) ,
Medicare ,
Orphan Drugs ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B ,
Trump Administration
The executive order shifts policy on enforcement of criminal regulatory offenses, steering away from criminal enforcement of strict liability offenses in regulatory matters....more
6/10/2025
/ Controlled Substances Act ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Guidance ,
Executive Orders ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Non-Enforcement ,
Regulatory Requirements ,
Strict Liability ,
Trump Administration
Recent developments include leadership changes, workforce reductions, and policy shifts at HHS and FDA, reshaping agency operations under President Trump’s administration....more
5/16/2025
/ Department of Health and Human Services (HHS) ,
Deregulation ,
Enforcement Priorities ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Life Sciences ,
Reduction of Force ,
Regulatory Agenda ,
Reorganizations ,
Rulemaking Process ,
Trump Administration
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more
5/6/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Congressional Committees ,
Drug Pricing ,
Executive Orders ,
Federal Budget ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Information Reports ,
Medicaid ,
Medicare ,
Most-Favored Nations ,
Pending Litigation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Rebates ,
Section 340B ,
Trump Administration
On April 15, 2025, President Trump signed an executive order titled “Lowering Drug Prices by Once Again Putting Americans First.” The order includes various provisions that are relevant to the pharmaceutical industry,...more
4/22/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Inflation Reduction Act (IRA) ,
Life Sciences ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
Regulatory Reform ,
Tariffs ,
Trump Administration
The Latham drug pricing and market access team invites you to read this digest of recent developments on healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more
4/8/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Government Agencies ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Manufacturers ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Tariffs ,
Trump Administration
FDA enforcement activities range from administrative actions like conducting establishment inspections and issuing warning letters to judicial enforcement through the Department of Justice, which can take the shape of civil...more