Episode summary
In this episode of 340B Pulse, host Muhammad Atif speaks with Joella Roland, counsel at Powers Pyles Sutter & Verville, the firm with the largest 340B practice in the country, representing safety net providers only. Before joining Powers in May 2025, Joella spent more than a decade inside the federal government: first at CMS, reviewing Medicare Part D drug regulations for compliance, then at HRSA as the agency's lead compliance officer and its information collection clearance officer. The conversation, recorded on 1 October 2026, is about how covered entities should read and respond to 340B regulatory changes when they arrive faster than ever and through different channels. Her central advice is to never act on a headline: every development needs to be read, charted, tracked and checked against your own policies, and even one that doesn't apply deserves a written note saying why.
Show notes
- The true definition of keeping up with 340B is a process for reading every development, not a feed of headlines.
- Why most operators falsely assume a proposed rule can wait until it is final.
- The critical difference between a development that needs an operational change and one that only needs a written note.
- How a new federal reporting requirement actually gets approved, from two Federal Register notices to an OMB number.
- Why your comment on the burden of a reporting requirement ends up in a report to Congress.
- How to use the voluntary CMS Part D repository as a practice round.
- What the rebate pilot demands before day one: cash, a TPA, a denial plan and manufacturer tracking.
- Where AI helps a short-staffed 340B team, and why a human still has to check it.
- Key Insights and Takeaways
- Joella Roland is counsel at Powers Pyles Sutter & Verville, which represents safety net providers only.
- She spent more than a decade in government, first at CMS and then at HRSA.
- At HRSA she was the lead compliance officer and the information collection clearance officer.
- We recorded on 1 October 2026, the day 10 manufacturers were approved for the rebate pilot.
- 340B developments now arrive through the Federal Register, litigation and agency websites.
- For every development, check whether it is proposed or final and when it takes effect.
- Chart it, track it and assess it against your current policies and procedures.
- If a development has no impact on your program, write down why.
- Short-staffed entities need one dedicated person, or outside counsel or a consultant, who knows both the entity and 340B.
- Apexus ACE certification is a good way to find people who know the program.
- The CMS newsroom, the 340B Report and law firm alerts often summarize changes before they are fully digested elsewhere.
- Under the Paperwork Reduction Act, a new information collection needs two Federal Register notices, public comment and OMB approval.
- Once OMB approves it, the collection carries an OMB number, and the agency must display it.
- Agencies report the burden of their information collections to Congress every year, so accurate burden comments matter.
- The CMS Part D repository is voluntary today, and CMS has proposed finalizing it.
- Use the voluntary period to practice, because this administration has tended to finalize what it proposes.
- The rebate pilot needs cash on hand, a ready TPA, a plan for denials and tracking of every manufacturer policy.
- Maximum fair price refunds run through a separate CMS process, so track drug pricing alongside the pilot.
- Moving 340B oversight from HRSA to CMS has been discussed since at least 2018.
- AI can help, but a human has to review its output, because AI often tells us what we want to hear.
- Over the next 30 days, prepare for the rebate model, Medicare and Medicaid cuts and manufacturer pressure.
- Some states are passing protections for covered entities, and advocacy at the state level helps.
