Tag Archives: covered entities

HHS’ Long-Awaited 340B Alternative Dispute Resolution Rule Is Finalized

In a move long anticipated by 340B Program participants, the Department of Health and Human Services (HHS) recently published its finalized 340B Administrative Dispute Resolution (ADR) rule, establishing formal processes for resolving certain types of disputes between 340B covered entities and drug manufacturers. 340B Program observers are cautiously optimistic that the ADR process will serve as a less … Continue Reading

Notice to Covered Entities: Manufacturer Seeking 340B Claims Data

By Brenda Maloney Shafer and Richard Davis on July 10, 2020 Posted in Compliance, Covered Entities, Guidance, Manufacturers

While we addressed recent wins for 340B covered entities concerning manufacturer transparency in a previous article, Merck Sharpe & Dohme Corp. (“Merck” or “Manufacturer”) now appears to seek its own access to 340B covered entity data in a different fashion. Specifically, over the past few weeks, Merck has sent letters to numerous 340B covered entities … Continue Reading

CMS Publishes 340B Drug Acquisition Cost Survey: Respond by May 15, 2020

By Brenda Maloney Shafer and Richard Davis on April 30, 2020 Posted in Covered Entities

On April 24, 2020, the Centers for Medicare and Medicaid Services (CMS) finalized and published a survey intended to capture the actual amounts paid by 340B covered entities (excluding critical access hospitals) for 340B drugs. CMS then intends to use the data collected from the survey to adjust the Medicare Part B reimbursement rate for 340B … Continue Reading

HRSA Unveils New 340B Flexibilities During COVID-19 Crisis

By Brenda Maloney Shafer and Richard Davis on March 23, 2020 Posted in Covered Entities, Legislation

As the COVID-19 crisis continues to unfold, the Health Resources & Services Administration Office of Pharmacy Affairs (HRSA OPA) has taken unprecedented steps to provide 340B Program participants with additional flexibility to help meet surging patient demand. At the highest level, HRSA OPA acknowledges that “this public health emergency may warrant additional flexibilities, especially to … Continue Reading

CVS Caremark Reverses Planned Payment Cuts to 340B Providers

By Brenda Maloney Shafer and Richard Davis on February 25, 2019 Posted in Covered Entities

CVS Caremark has decided not to implement reimbursement reductions which may have had adverse effects on Covered Entities and their retail pharmacies (including contract pharmacies). This decision, coupled with the recent court decision invalidating certain aspects of the proposed Medicare Part B payment reductions for 340B drugs,[1] provides some positive news for these Covered Entities … Continue Reading

The Omnibus Guidance is Dead!

By Alyce Katayama and Elizabeth Gebarski on February 2, 2017 Posted in Compliance, Covered Entities, Guidance

The proposed 340B Drug Pricing Program Omnibus Guidance that was issued in August 2015 and promised to turn the 340B world on its head was withdrawn on January 30, 2017. Not that most covered entities are upset. The proposed 340B Drug Pricing Program Omnibus Guidance proposed a host of changes to the 340B Drug Pricing … Continue Reading

Key Takeaway from 340B Conferences – Audits

By Alyce Katayama and Elizabeth Gebarski on March 16, 2016 Posted in Audits, Certification/Recertification, Compliance, Contract Pharmacies, Covered Entities, Diversion, Duplicate Discounts

Yep. Audits. They are happening. And, chances are, if your covered entity (“CE”) hasn’t experienced one yet, it is coming to you sometime soon. At both 340B University (hosted by Apexus, the prime vendor for the 340B Drug Pricing Program) and the 340B Coalition Conference (hosted by 340B Health) many CEs we interacted with had already experienced … Continue Reading

PhRMA 2-0 in The Orphan Drug Wars

By Alyce Katayama and Elizabeth Gebarski on October 19, 2015 Posted in Compliance, Covered Entities, Guidance, Manufacturers, Orphan Drugs

U.S. Federal District Court Judge for the District of Columbia, Rudolph Contreras, ruled Wednesday, October 14, 2015 that manufacturers need not offer 340B discounts for orphan drugs sold to a specified group of covered entities (CEs), regardless of how the orphan drug is used. To make a very long story short, in 2010, the Patient Protection … Continue Reading

Breaking Down the Proposed Omnibus Guidance – Child Sites

By Alyce Katayama and Elizabeth Gebarski on October 12, 2015 Posted in Certification/Recertification, Compliance, Contract Pharmacies, Covered Entities, Guidance

It is coming down to the wire – comments are due on the 340B Drug Pricing Program Omnibus Guidance (“Guidance”) in about two weeks! On October 28, 2015 the comment period will be closed and there will be nothing left to do but sit back and wait. This post will focus on an aspect of … Continue Reading