Two recent federal court cases signal new significant developments with respect to the 340B Drug Pricing Program. Specifically: (1) new federal district court litigation challenging a recent HRSA Notice involving 340B Program...more
In October 2021, we reported on an uptick in the passage of state drug price transparency legislation. As an update to that report, as of October 2023, approximately 22 states have now passed drug price transparency laws...more
On February 14, 2023, the U.S. Department of Health and Human Services (HHS) published a report identifying three models that the Center for Medicare & Medicaid Services’ (CMS) Center for Medicare & Medicaid Innovation (CMMI)...more
The 340B Drug Pricing Program is a government program, administered by the Health Resources and Services Administration (HRSA), that allows qualifying hospitals and clinics that treat low-income and uninsured patients to buy...more
On January 30, 2023, the Court of Appeals for the Third Circuit issued a precedential decision rejecting a policy of the Department of Health and Human Services (HHS) in implementing the 340B Program. Under that policy, HHS...more
The Inflation Reduction Act’s (“IRA”) drug price negotiation provisions have captured the pharmaceutical and biotech industry’s attention. In part, the IRA allows the Centers for Medicare & Medicaid Services (“CMS”) to...more
1/27/2023
/ Biologics ,
Biotechnology ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Drug Pricing ,
Inflation Reduction Act (IRA) ,
Medicare Part B ,
Medicare Part D ,
Negotiations ,
OMB ,
Prescription Drugs ,
Public Comment
On August 7, 2022, the U.S. Senate passed the Inflation Reduction Act of 2022, which includes some of the most significant drug pricing-related changes since the passage of the Medicare Prescription Drug Improvement...more
8/10/2022
/ Civil Monetary Penalty ,
Drug Pricing ,
Enforcement ,
Food and Drug Administration (FDA) ,
Medicaid ,
Medicaid Drug Rebate Program ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Pending Legislation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Rebates ,
Secretary of HHS
Litigation involving drug price reporting under the Medicaid Drug Rebate Program (MDRP) has been very active in 2022. Most recently, on August 3, 2022, an Illinois federal jury levied a $61 million verdict against Eli...more
8/5/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Funding ,
Medicaid ,
Medicaid Drug Rebate Program ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reporting Requirements ,
Section 340B
In 2016, states began passing pharmaceutical price reporting laws. These laws are designed to bring transparency to a pharmaceutical manufacturer’s drug pricing process by requiring drug manufacturers to report pricing and...more
In 2016, states began passing pharmaceutical price reporting laws. These laws are designed to bring transparency to a pharmaceutical manufacturer’s drug pricing process by requiring drug manufacturers to report pricing and...more