Category Archives: Contract Pharmacies

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

By Michael Glen, Richard Davis, Michael French, Brenda Maloney Shafer and Madison Hartman on Posted in Contract Pharmacies, Legislation, Manufacturers
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

Continuing Changes in the 340B Space: New Restrictions and Shifting Alliances

By Brenda Maloney Shafer, Richard Davis, Michael French and Madison Hartman on Posted in Compliance, Contract Pharmacies, Covered Entities, Legislation
As detailed further in our article on the current state of the 340B Program and what to expect in 2023, a growing list of manufacturers have taken the step of significantly restricting 340B pricing for fills completed by contract pharmacies. Over the last few weeks, the number and scope of these restrictions have only continued to grow. … Continue Reading

Brenda Shafer, Michael French and Richard Davis Author Law360 Article on Questions Related to Section 340B Drug Pricing

By Brenda Maloney Shafer, Michael French and Richard Davis on Posted in Contract Pharmacies, Legislation, Litigation
Quarles Health & Life Sciences attorneys Brenda Shafer, Michael French and Richard Davis recently wrote an article for Law360 about questions surrounding the ability of the Health Resources and Services Administration’s ability to enforce key requirements related to the Section 340B drug pricing program. In the article, Shafer, French and Davis address aspects of the 340B program … Continue Reading

The End of a Wild Year for 340B: HHS Issues Advisory Opinion and New GAO Report Sheds Light on HRSA’s Enforcement Pullback

By Brenda Maloney Shafer, Richard Davis and David Blank on Posted in Contract Pharmacies, Covered Entities, Guidance, Manufacturers
2020 was a tumultuous year for virtually everyone and everything, and the 340B Program was no exception. As we outlined in previous articles, many drug manufacturers have decided that the Health Resources and Services Administration’s Office of Pharmacy Affairs (“HRSA OPA”) guidance on contract pharmacy[1] arrangements is no longer binding. Accordingly, many drug manufacturers have … Continue Reading

Key Takeaway from 340B Conferences – Audits

By Alyce Katayama and Elizabeth Gebarski on 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

Comparing 340B University and the 340B Coalition Conference

By Alyce Katayama and Elizabeth Gebarski on Posted in Audits, Contract Pharmacies, Covered Entities, Guidance, Manufacturers
Maybe it is just us, but we wanted to know whether we would get a different experience at 340B University versus the 340B Coalition Conference.  In some ways, these conferences could not have been more different. But, at the heart of it all, each had the same underlying education of stakeholders so that covered entities … Continue Reading

Top Takeaway from 340B University and 340B Coalition Conference

By Alyce Katayama and Elizabeth Gebarski on Posted in Compliance, Contract Pharmacies, Covered Entities, Guidance, Manufacturers
This year we once again had boots on the ground for 340B University and the 340B Winter Coalition Conference for a four-day 340B Drug Pricing Program (340B Program) adventure. 340B University is free of charge and is put on by the 340B Prime Vendor, Apexus. The 340B Coalition Conference, on the other hand, charges a fee … Continue Reading

Site Neutral Payments Put 340B Child Sites in Jeopardy

By Alyce Katayama and Elizabeth Gebarski on Posted in Certification/Recertification, Compliance, Contract Pharmacies, Legislation
Just when you thought you understood all the threats facing the 340B Drug Pricing Program (“340B Program”), along comes the Bipartisan Budget Act of 2015 (“BBA 2015). BBA 2015 changes the way in which new off-campus hospital outpatient departments (“HOPDs”) will be paid come January 1, 2017. This change could have a substantial impact on … Continue Reading

Breaking Down the Proposed Omnibus Guidance – Child Sites

By Alyce Katayama and Elizabeth Gebarski on 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

The Proposed 340B Drug Pricing Program Omnibus Guidelines Have Landed

By Alyce Katayama and Elizabeth Gebarski on Posted in Audits, Certification/Recertification, Compliance, Contract Pharmacies, Covered Entities, Diversion, Duplicate Discounts, Legislation, Manufacturers
It is official: The Health Resources and Services Administration (“HRSA”) has published the long-awaited “Mega Guidance.” The Proposed 340B Drug Pricing Program Omnibus Guidelines (“Guidelines”) were published in the Federal Register on August 28, 2015. Any comments must be submitted on or before October 27, 2015. The proposed Guidelines aim to “add clarity in the marketplace for all … Continue Reading

Near Miss on Congressional Overhaul of 340B Program

By Alyce Katayama and Elizabeth Gebarski on Posted in Audits, Compliance, Contract Pharmacies, Covered Entities, Legislation, Manufacturers, Orphan Drugs
In just a matter of days, changes to the 340B Program were proposed and then withdrawn from H.R. 6, The 21st Century Cures Act. Had hospitals, health systems, and related lobbying groups not been closely watching the Act, the changes might have quietly gone through when the 21st Century Cures Act was unanimously passed out of Committee on May 21, 2015. The 21st Century Cures initiative, advanced by the House Energy … Continue Reading

340B Program Covered Entities: Some Items for Your Worry List

By Alyce Katayama on Posted in Contract Pharmacies, Covered Entities, Manufacturers, Orphan Drugs
When 340B covered entities contemplate the future, they can find a number of issues to worry about. Here is a thumbnail on some of them. Orphan Drugs There is a possibility that the orphan drug issue will be resolved unfavorably to covered entities. That issue arises out of a 2014  court decision, Pharmaceutical Research and Manufacturers … Continue Reading

The Message Is Clear from OPA Director Pedley

By Alyce Katayama on Posted in Audits, Compliance, Contract Pharmacies, Covered Entities, Duplicate Discounts, Manufacturers, Orphan Drugs
Covered entities should be constantly preparing for  audit.  That  was the message, loud and clear, from Office of Pharmacy Affairs Director, Cmdr. Krista Pedly, who spoke by webcast  at the recent Winter Conference of the 340B Coalition in San Francisco.  That preparation, she said, should include making use of the compliance tools available through Apexus … Continue Reading
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