Category Archives: Manufacturers

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

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 January 5, 2021 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

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

Comparing 340B University and the 340B Coalition Conference

By Alyce Katayama and Elizabeth Gebarski on March 9, 2016 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 February 29, 2016 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

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

The Proposed 340B Drug Pricing Program Omnibus Guidelines Have Landed

By Alyce Katayama and Elizabeth Gebarski on August 28, 2015 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

Finally! HRSA Proposes Manufacturer Civil Monetary Penalties

By Alyce Katayama and Elizabeth Gebarski on June 18, 2015 Posted in Compliance, Covered Entities, Legislation, Manufacturers, Orphan Drugs

On June 17, 2015 the Health Resources and Services Administration (“HRSA”) finally published its much anticipated proposed rule, the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation. Comments must be submitted via the online portal, email, or US Mail by August 17, 2015. Keep in mind, all submitted comments will be … Continue Reading

Near Miss on Congressional Overhaul of 340B Program

By Alyce Katayama and Elizabeth Gebarski on May 28, 2015 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

How Much Will You Pay for an Inaccurate 340B Ceiling Price?

By Alyce Katayama and Elizabeth Gebarski on May 14, 2015 Posted in Compliance, Legislation, Manufacturers

Under the authority granted it by the Patient Protection and Affordable Care Act, the Health Resources and Services Administration (HRSA) is moving forward to laying the groundwork for imposing civil monetary penalties on manufacturers that overcharge covered entities under the 340B Program. HRSA has submitted its second Information Collection Request (ICR) regarding calculation and verification … Continue Reading

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

By Alyce Katayama on March 22, 2015 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 February 16, 2015 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