Category Archives: 340B Drug Pricing Program

340B Hospitals File Suit in Wake of Hospital Outpatient Cuts

Back in July, my colleague Tom Barker told you about a CMS proposal to institute a fundamental reimbursement methodological change for 340B drugs used in the hospital outpatient setting.  We have noted before the link between the Medicaid prescription drug rebate program and the 340B program.  As a refresher, in order to have its outpatient drugs covered by Medicaid, the manufacturer must agree to three separate requirements.  First,… More

CMS Proposes Fundamental Reimbursement Methodological Change for 340B Drugs Used in Hospital Outpatient Setting

We have noted before the link between the Medicaid prescription drug rebate program and the 340B program.  As a refresher, in order to have its outpatient drugs covered by Medicaid, the manufacturer must agree to three separate requirements.  First, the manufacturer must agree to provide a rebate to Medicaid equal to the greater of 23.1% of the average manufacturer price (AMP) of the drug, or AMP minus the best price of the drug. … More

Summary of the “340B Drug Pricing Administrative Dispute Resolution” Proposed Rule

Overview & Analysis

On August 12, 2016, the Health Resources and Services Administration (HRSA) published a proposed rule entitled “340B Drug Pricing Program; Administrative Dispute Resolution” (Proposed Rule).  The Proposed Rule follows the Advanced Notice of Proposed Rulemaking (APRM) issued by HRSA on September 20, 2010 and aims to establish requirements and procedures for the 340B Program’s administrative dispute resolution (ADR) process.  Interested parties may submit written comments on or before October 11,… More

OIG Says State Methods For Preventing Duplicate Discounts Are Vulnerable

Introduction

The Office of Inspector General (OIG) recently issued a report titled “State Efforts to Exclude 340B Drugs from Medicaid Managed Care Rebates.”  In its report, OIG wanted to study the different methods that states were using to prevent illegal “duplicate discounts” that occur as a result of the interaction between the Medicaid drug rebate program and the 340B drug-discount program.  OIG revealed that the systems a majority of states have for preventing duplicate discounts are actually quite vulnerable,… More