On April 19, 2024, the Health Resources and Services Administration (HRSA) published a final rule (Final Rule) in the Federal Register adopting several changes to the current administrative dispute resolution (ADR) process...more
On November 3, 2023, the U.S. District Court for the District of South Carolina issued a decision granting in large part Genesis Health Care’s (Genesis’s) motion for summary judgment in its litigation against the Health...more
On May 23, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program...more
On November 30, 2022, the Health Resources and Services Administration (HRSA) published a proposed rule (Proposed Rule) in the Federal Register that proposes to introduce several changes to the current administrative dispute...more
On October 13, 2021, the in-person portion of the annual informaconnect Medicaid Drug Rebate Program (MDRP) Conference concluded in New Brunswick, New Jersey. A day earlier, on October 12, 2021, a joint hearing was held in...more
10/19/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Medicaid ,
Medicaid Drug Rebate Program ,
Medicare Part B ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
As we begin the new year, we wanted to highlight two final developments from December 2020:
First, on Dec. 27, 2020, the stimulus legislation H.R. 133, the Consolidated Appropriations Act of 2021 (link), Pub. L. 116‑260...more
1/8/2021
/ Civil Monetary Penalty ,
Consolidated Appropriations Act (CAA) ,
Drug Pricing ,
Financial Stimulus ,
MACPAC ,
MDRP ,
MedPAC ,
New Legislation ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Section 340B
On December 14, 2020, the U.S. Health Resources and Services Administration (HRSA) published a final rule (Final Rule) in the Federal Register defining an administrative dispute resolution (ADR) process for the 340B Drug...more
Yesterday, the Health Resources and Services Administration (HRSA) issued a Final Rule (Final Rule) that accelerates the effective and implementation date of the 340B Ceiling Price and Civil Monetary Penalties final rule...more
This week, the Health Resources and Services Administration (HRSA) issued a Proposed Rule (Proposed Rule) to cease any further delay of the 340B Ceiling Price and Civil Monetary Penalties regulation (CMP Final Rule) and...more
On May 11, 2018, President Trump and Department of Health and Human Services (HHS) Secretary Alex Azar delivered highly anticipated speeches regarding the administration's plan to reduce drug prices.
...more
5/15/2018
/ Biosimilars ,
Comment Period ,
Competition ,
Drug Pricing ,
Life Sciences ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Section 340B ,
Trump Administration
On February 12, 2018, the White House Office of Management and Budget released an overview of the president's Fiscal Year (FY) 2019 Budget (the Budget), which makes, among many others, several proposals regarding drug pricing...more
2/16/2018
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Federal Budget ,
MDRP ,
Medicaid Reimbursements ,
Medical Reimbursement ,
Medicare Part B ,
Medicare Part D ,
Section 340B ,
Trump Administration
Last week, the Health Resources and Services Administration (HRSA) issued a Final Rule delaying the effective date and the enforcement date of the 340B Drug Pricing Program Ceiling Price and Civil Monetary Penalties Rule (the...more
On 20 March 2017, the Health Resources and Services Administration (HRSA) published an Interim Final Rule (IFR) delaying the effective date of the 340B Ceiling Price and Civil Monetary Penalties (CMP) Rule (the Final Rule)...more