Questions Loom as HHS Appointment Approaches

Lindsay Bealor Greenleaf, JD, MBA, vice president and head, Federal and State Policy, at Advi Health, spoke with The American Journal of Managed Care^®(AJMC®) about the potential appointment of Robert F. Kennedy Jr as HHS secretary and what it could mean for health policy in the next 4 years.

It was just last week that President-elect Donald Trump made the announcement of Kennedy as his choice to lead the public health agency, shining the spotlight on the former independent presidential candidate and his often controversial stances on health policy and the lack of consensus on his potential confirmation, sharply divided along party lines.

This interview has been edited for clarity.

AJMC: How much freedom will Robert F. Kennedy Jr have if he’s confirmed as HHS Secretary?

Greenleaf: It just depends on which agency underneath HHS that we're talking about and which law the agency is implementing. There's a ton of authority that would come with a role like HHS Secretary, but where specifically that discretion lies depends on which law we're talking about that his agencies would be carrying out. I think the FDA is where people are focused the most and how might that look with RFK Jr at the head of HHS. We know that historically, there have not been many examples of significant political pressure being put on the FDA. But the more that we're learning about this, some of that is more just a factor of norms and not necessarily a factor of specific statutory constraints preventing that.

So you could possibly see quite a bit of influence from RFK over the FDA approval process. There's a specific section of the statute, it's 21 USC 393, and that is a part of the US Code that specifies that it's the Secretary, through the commissioner, that is responsible for executing the Food and Drug Cosmetic Act [FDCA]. That's just another way of saying an HHS Secretary does have pretty explicit authority when it comes to what's coming out of the FDA and how they're implementing the FDCA.

Past examples of that include President Obama's HHS Secretary, Kathleen Sebelius, who cited that part of the statute in 2011 when she overruled then FDA Commissioner Margaret Hamburg, MD, denying Teva Pharmaceutical's request for emergency contraception, Plan B, to be made available for nonprescription use. That's 1 example, and another example of political pressure, if you will, on the FDA is a little different.

But more recent is during the pandemic back in 2020. It's reported that then chief of staff to President Trump, Mark Meadows, called up Stephen M. Hahn, MD, FDA commissioner at the time, and told him that Pfizer's vaccine needed to be approved that day or he could submit his resignation the following day. Supposedly, Pfizer's COVID vaccine was given emergency use authorization that night. So, you have these stories, you have examples here and there where political influence and the discretion that an HHS secretary would have over agencies like that. So yeah, it's a big job. It would come with a lot of authority. But of course, that authority is constrained by the laws around it and Congress.

Lindsay Bealor Greenleaf

AJMC: During the first Trump administration, some government officials in his cabinet believed that they were able to do things beyond the scope of their position. Are there any such areas in the HHS that might surprise RFK Jr as not being part of his new role?

Greenleaf: There were several examples during the first Trump term where CMS tried to leverage authority that was reined in by the courts. But the examples that are top of mind for me happen to be more procedural in nature, where the court struck it down for missing some administrative steps along the way. They didn't necessarily strike down the merits of what CMS was trying to do.

One notable example is related to the 340B discount program. The Trump-led CMS, at the time, attempted to reimburse 340B hospitals for Part B physician-administered drugs at a significantly lower rate, given that 340B hospitals are keeping quite a profit off of that drug spread, so they reimbursed the average sales price minus 22.5%. The hospital sued, and that made its way up to the Supreme Court. The Supreme Court struck down that payment cut because it said CMS failed to do a cost acquisition survey before instituting those cuts, and under the law, they were supposed to have done a survey first. Instead, CMS had cited a MedPAC report. Basically, they didn't have the right information on hand before doing that. You could see Trump 2.0 CMS just following the steps of the CMS that the Supreme Court told them to take and they could try again.

Another example is when Trump tried to institute international reference pricing for Part B drugs through the Center for Medicare and Medicaid Innovation. That Most Favored Nation model was enacted as a interim final rule right before Trump was leaving office. That model was blocked by the court because of the use of the interim final rule process; the court didn't rule on the merits of the model. They said, you tried to finalize this through a rulemaking avenue that this policy doesn't fit into.

So, there have been several times that the Trump administration tried to pursue various health care policies that were pushed back on and blocked. But those examples that come to mind for me were more procedural in nature, things that could probably be worked around in a second term. So we'll see.

AJMC: What aspects of RFK Jr’s proposed policy would he be able to enact? What will meet more resistance?

Greenleaf: I don't know the breadth of his authority on regulating food and pesticides, but given the amount of attention he's given to those issues, I would think that's a natural place for him to start and where he would lean pretty heavily into. In terms of implementing other things on the health care front, what's related to the FDA approval process, he's talked at length about his thoughts on vaccines, etc. I think we're all still trying to sort that out. It's really not clear yet what exactly could be changed on day 1.

I gave you those examples of how different folks in this role could influence the FDA process and the authority that I mentioned the HHS Secretary has when it comes to approvals, so you can certainly see RFK Jr pursuing the policies that he wants from that context. I think though generally one big thing that is clear at the moment, just the distraction of relitigating the merits of things like vaccines, having to just even have these conversations that we've never had to have before, that alone could just slow things down and just take up a lot of airtime.

AJMC: How could downsizing parts of the government, including the FDA, affect the agencies he’s overseeing?

Greenleaf: That would certainly slow things down that we're talking about. That would be a lot of disruption and upheaval, although I've seen conflicting quotes from him. So for me, I'm not entirely sure what his plans are from a staffing standpoint. I've seen some quotes that he would be cutting staff. Other reports are saying that he'd be swapping certain people in: some people coming in, some people going out. So to start, I think it's just a bit unclear and we've got a ways to go before we have a better handle on what that's going to look like. If you're cutting a lot of staff, that's really going to slow down implementation of any of these things he's trying to do.

AJMC: What are the chances of RFK Jr being confirmed to HHS Secretary?

Greenleaf: The short answer is, we don't know. I don't know. But we're watching this very closely to see senators' reactions. We're, of course, most closely watching to see what the Republican senators are saying, probably assuming that Democrats would be aligned against this. But you never know. There could be some wild cards on the Democrat side, too, that may be in support of him. So we're tracking these comments closely as we go here. But I think we're not just tracking what's being said about Kennedy. Republican senator reactions to any and all of these appointments is notable and could be telling into how they want to handle the Kennedy confirmation.

That's the kind of dynamic we're kind of watching to see how that plays out. But as of right now, it is definitely too soon to tell. We will have a better idea in the coming weeks.