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
The Centers for Medicare & Medicaid Services (CMS) released the calendar year 2026 Physician Fee Schedule (PFS) proposed rule, which was published in the Federal Register on July 16, 2025. The comment period ends on September...more
7/29/2025
/ Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Drug Pricing ,
Federal Register ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Life Sciences ,
Medicare ,
Medicare Part D ,
Outpatient Prospective Payment System (OPPS) ,
Pending Litigation ,
Pharmaceutical Industry ,
Pharmacies ,
Physician Fee Schedule ,
Prescription Drugs ,
Proposed Rules ,
Section 340B ,
Vouchers
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
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
Welcome to the latest edition of our Healthcare & Life Sciences Market Update, in which we explore the evolving landscape of investment trends, regulatory challenges, and strategic opportunities shaping the global market....more
The final guidance describes FDA’s enforcement discretion policy for sharing scientific information on unapproved uses of approved products and suggests a safe harbor for sharing off-label information consistent with the...more
1/16/2025
/ Compliance ,
Data-Sharing ,
Enforcement ,
Final Guidance ,
Final Rules ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Off-Label Use ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Authority ,
Regulatory Requirements ,
Risk Management ,
Safe Harbors