Tag Archives: HHS

The 340B Program in 2024: A Tumultuous Year in Review

By Brenda Maloney Shafer, Richard Davis and Michael French on Posted in Contract Pharmacies, Legislation
The 340B Program has continued to undergo significant upheaval in 2024 that has the potential to bring about impactful changes to how the 340B Program operates moving forward. These developments have left 340B stakeholders in a position of increasing uncertainty. This article synthesizes these key developments of 340B Program developments and trends from the past … 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

340B Litigation Updates and Other Program Developments

By Brenda Maloney Shafer and Richard Davis on Posted in Covered Entities, Legislation
340B Medicare Part B Adjustment Litigation Update In the latest development of the ongoing 340B Medicare Part B payment reduction controversy, US District Judge Rudolph Contreras again concluded that the Department of Health and Human Services (HHS) exceeded its statutory authority in implementing a reduced Medicare reimbursement rate for 340B Program drugs for 2019. In … Continue Reading

We’re 340Back! Review of Major Developments to the 340B Program

By Brenda Maloney Shafer and Richard Davis on Posted in Audits, Covered Entities, Legislation
It’s been a roller coaster two years for the 340B Program, and we are now back to review some of the major developments and program changes during this time. On the highest level, despite a flurry of proposed legislative action, the 340B Program remains largely unchanged from where it stood prior to 2017. As covered … 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

Finally! HRSA Proposes Manufacturer Civil Monetary Penalties

By Alyce Katayama and Elizabeth Gebarski on 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

340B Reform Legislation: Is Anything in the Offing?

By Alyce Katayama on Posted in Legislation
As readers of this blog already know, manufacturers and some legislators believe the 340B program has grown too large, suffers from mission creep and needs reform. They argue that the program’s purpose is simply to reduce drug costs for the uninsured and the indigent, nothing more. All three of the federal agencies with program oversight … Continue Reading
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