Powers Pulse with Joella Roland
Could recent developments affect STD clinics’ access to 340B drug pricing?
As 340B access challenges continue, recent developments could have important implications for STD clinics participating in the 340B Drug Pricing Program—and may warrant action now.
In this Powers Pulse video, Joella Roland, Counsel in Powers’ Drug Pricing and 340B Program Practice, highlights recent actions by drug manufacturers and federal agencies that are restricting access to 340B pricing and outlines steps STD clinics can consider to protect their 340B access and eligibility.
This video is not to be construed or relied upon as legal advice.
Related: Watch Powers Counsel Greg Doggett explain how 340B covered entities can navigate evolving manufacturer data requests in Responding to Manufacturer 340B Data Mandates.
Connect with Joella at the 340B Grantees Fall Conference
Joella will also be presenting at the Fall 2026 340B Grantees Conference in Milwaukee, September 26–28. See her sessions in the link below.
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Read Video Transcript
Joella Roland: Hi, I’m Joella Roland, Counsel at Powers Pyles Sutter and Verville, or Powers Law for short. We have the largest and one of the longest-standing 340B practices in the country. We represent covered entities and pharmacies exclusively, never drug manufacturers.
I want to clarify that this presentation is for informational purposes only. It should not be construed or relied upon as legal advice.
Increasing Challenges for STD Clinics
Today, I want to talk about a rapidly developing trend in the 340B space: intensifying efforts by drug manufacturers and the federal government to discontinue 340B pricing to STD clinics.
Powers has been closely involved in these developments.
Most recently, we represented an STD clinic that intervened in litigation by four major drug manufacturers challenging HRSA’s certification of STD clinics and the in-kind model to confer 340B eligibility.
Litigation isn’t the only tool that manufacturers and the federal government are using.
We’ve recently heard of two major drug manufacturers, Amgen and Novartis, refusing to honor 340B pricing for STD clinics and delivering this notice to the clinics directly.
At the same time, HRSA has imposed additional certification and recertification requirements on STD clinics and post-audit documentation requests at an unprecedented rate and CDC has also forecasted changes to STD prevention funding that could affect the number of jurisdictions eligible to receive federal funding.
So what Can a STD Clinic Do?
There are steps covered entities can take now to protect their eligibility and prepare for what comes next.
First, get your documentation in order. Ensure that you have the CDC Notice of Award, subrecipient agreement, and other documentation that confers your eligibility for the 340B Program.
Second, understand your eligibility pathway. Review your CDC funding requirements and see whether changes to CDC funding could affect your eligibility and if you rely on in-kind contributions to qualify, consider whether you could rely on direct funding from your state or local jurisdiction.
Third, be prepared for increased scrutiny. Develop responses to common HRSA post-audit documentation requests and certification and recertification questions before they arise.
Fourth, document manufacturer restrictions. If a manufacturer refuses to honor 340B pricing, preserve all correspondence and records on their affected drugs, and work with counsel to evaluate whether the alternative dispute resolution process or another remedy may be appropriate.
If your organization is navigating these issues, consider consulting experienced 340B legal counsel.