340B Drug Pricing Program: What Regulatory and Legislative Changes Are on the Horizon?

In this clip, Christopher Topoleski, Director of Federal Legislative Affairs for the American Society of Health-System Pharmacists (ASHP), talks about how the legislative landscape of the 340B Drug Pricing Program has evolved and what's to come.

Transcript

"ASHP has long supported the 340B Drug Pricing Program. For the almost 30 years that it has been in place, ASHP has worked to preserve the program, expand access to patients, and to also work with Congress as it may consider any changes and work with HRSA as it implements the program. Last year, ASHP testified in front of a Senate panel providing our view on the program and any potential changes that can happen in the future. So there has not necessarily been a lot of legislative changes over time on the program. A lot of it has evolved naturally. HRSA has put out a number of guidances over the history of the program, but not necessarily a consolidated rule. They tried to do so a few years ago, but it was determined by the courts that they did not have sufficient regulatory ability to do or the authority by the Congress. So that's kind of where this new interest in 340B has happened over the past couple of years.So we think that, what we're looking at, there's some regulations that have been put in place, there was one that put a cut to the 340B drugs under the Medicare outpatient program. That one we vehemently opposed and we were very concerned that that could have some effects on patient access. So going forward, we think that HRSA is not necessarily likely to put out a lot of regulations. There's one that's going to be coming up that's accelerated from next July up to January on ceiling prices. That one's been long overdue and has been kind of kicked down the road for a couple of years. Going forward though, I think if you look at legislation where we're going to see some action. On the Senate side, the Senate Health Committee, which is in charge of the program, held a series of hearing last year which I mentioned ASHP testified. I think that the point they're at right now, they're doing exploratory educational sessions, but I don't necessarily think we're going to see some sweeping legislation. If we see things, it might be to give HRSA some additional authority and maybe some transparency. On the House side, it's a different dynamic. So the Energy and Commerce Committe on the House held a lot of hearings last year, many were critical of the program. Now, however, the House is flipped from a Republican control to a Democratic control. And the Energy and Commerce Committee now will have many more supporters of the program in its leadership role. So I think going forward, we'll see some legislation next year. I don't know if the legislation is going to necessarily expand or contract the program."