Leah Ralph on the Political and Legal Obstacles to 340B Reform

The uncertainty in the political climate, along with the limited authority of the Health Resources and Services Administration (HRSA) within HHS, makes it difficult to predict whether the 340B program will be reformed in coming years, according to Leah Ralph, director of health policy at the Association of Community Cancer Centers.

Transcript (slightly modified)

There are many healthcare programs that rely on funding from 340B. Given this, what hope is there for real reform in 2017/2018?

The current political environment creates a lot of uncertainty around when or if we will see some comprehensive reform on the 340B program. This is something that people have been calling for, for a long time, to really fundamentally revisit the program and understand the reach that it is having, the patients that it’s serving, and the purpose of the program.

We’ve seen HRSA attempt to kind of put some parameters around the program with the mega-guidance that they had recently released. In January, that rule was actually pulled back, largely more so because of the Trump administration’s regulatory review effort, as a new administration does when they come to the White House.

I think it’s a challenging issue, and it’s hard to see a path forward on what policy maker is able to fundamentally make some of those changes. Again, in the mega-guidance we did see this effort to tighten the definition of a patient that would be eligible for discounted 340B drugs. I think in some ways the guidance was trying to please both sides, and in an effort maybe not both sides weren’t entirely happy, and they’re also limited in their authority.

They’ve been really strictly limited in the legal authority that they have to regulate around the program, which is why we’re seeing things like guidance and not regulations, so it’s unclear what the path forward is on that. I think that’s another example of, if the administration is as interested in drug pricing reform as some of the tweets that we’ve seen from the president, that may be part of a broader effort, but I think it’s going to need to be part of a broader vehicle to get anything accomplished.