Biden’s First 100 Days in Healthcare: Handling the COVID-19 Pandemic, Prospects for Drug Pricing Reform, and the Notable Lack of an FDA Commissioner

Marc Samuels, J.D., M.P.H.

Marc Samuels, J.D., M.P.H., CEO spoke recently with Senior Editor Peter Wehrwein about the Biden administration’s healthcare accomplishments during its first 100 days — and also prospects for future action on drug pricing and other healthcare-related matters. ADVI is a strategic advisory services firm in Washington, D.C. Prior to founding ADVI and its predecessor company, HillCo HEALTH, Marc served in President George H.W. Bush’s administration and worked for President George W Bush when he was governor of Texas.

Here are excerpts from a transcript of their conversation that has been edited for clarity and length:

On the biggest wins — and any missteps

The biggest win has to be the handling of the COVID-19 pandemic, especially in regards to the vaccine distribution and elevation of the issue as a public health imperative. It is maybe also the one bright moment in the transition from the former Trump administration to this administration. And, you know, the Biden team working well with the inner workings of Operation Warp Speed and HHS to really double down on those efforts, expand the public health piece, in terms of testing and overall treating the COVID-19 as a public health imperative and then working with the states to operationalize now, 200-plus million individuals being vaccinated. Huge, huge, win. The Biden team a lot of experience from their previous lives in terms of the president himself and Ron Klain [Biden’s chief of staff] dealing with Ebola and other issues.

You know you asked is there a misstep. I think in very general terms that the blanket treatment of all Trump regulations in the healthcare space is bad. Stopping them or overturning them could potentially lead to letting good policy go to waste.

There's one provision, especially, I think, worth noting, the Medicaid value-based arrangement rule that's sort of sitting in languishing with the potential for being stopped like many of the other Trump era rules and that that would be a loss.

By the same token, the reorganization, the picks that that the president has made for CMS and for CMMI (the Center for Medicare and Medicaid Innovation) have been great. In a way I think that’s another of the big wins. He has picked some people that I think are widely well regarded and that will take action and not only move his agenda but, you know, the good public health and good policy forward, especially at CMMI, which is an agency that has had some fits and missteps along the way.

More on the value-based Medicaid arrangement rule

The rule has applied does one thing and accomplishes another. So it what it does is allow a new contracting template between states and manufacturers who want to put forward a value-based payment arrangement between the parties. And what it really accomplishes is a way to do that, without affecting contracts that are in place with, you know, in the Medicare space, in commercial, and changes to Medicaid best-price, which is another federal rule that underlies the Medicaid program.

For a group as yet to be defined initiatives like the Netflix pay arrangement in Washington and Louisiana for hepatitis C, like the value-based contracting arrangements in Oklahoma, Arkansas, and other states — New York, Massachusetts, all have passed state law and rules in this area — it would allow all that to occur without going through the time consuming sometimes the onerous state plan amendment process, basically saying, hey, if we've approved a model that you the state, like, you can move move forward with it without a great deal of administrative red tape.

The rule right now is in limbo. Our best guess is that it does suffer the fate of other Trump era rules.

The other thing that would be nice if Congress included something on value-based arrangements as they debate drug-pricing reform. If you had legislative certainty that these flexibilities exist, then that would eliminate worries over a new HHS or CMS leadership or any new administration.

On prospects for drug pricing law or regulation

I think that the President's plans for drug pricing will hinge a lot on what gets done legislatively first in the infrastructure bill. If there’s change, then the Biden team will focus on implementation. If instead Congress punts and decides not to worry or put anything on drug pricing in in that legislation, then the Biden team will be more aggressive with administrative power, which is his greatest ability to do anything in Medicare. And most of that will occur within CMMI. Things like government negotiation, international reference pricing, looking at merging parts or all of Medicare Part B and D.

The other thing that's interesting, I never thought the President's plans would be limiting as compared to H.R. 3, but H.R. 3 is bad policy that applies across payers, including commercial plans and would cause dramatic change, not necessarily for the better.

So the Biden team really has their work cut out for them if Congress doesn’t do something — and maybe if they do. Implementation will take time.

On prospects of the infrastructure bill drug having provisions that include the infrastructure bill

Sen. Robert Menendez

Democrats themselves within the Senate and House have mixed reaction. For example, Bob Menendez, the Democratic senator from New Jersey, has been, so far, against putting aspects of the international price index-most favored nation in law.

Certainly everybody supports the inflationary caps. That seems to have broad Republican and Democratic support.

What I would like to see is Congress having an honest debate about the role played by everyone in the prescription drug supply chain. We need to be talking about the differences in gross-to-net price, hospital markups, rebates paid to middlemen.

We have come a long way in recent years with these discussions around roles. Now the Trump administration didn't enact much; they talked a lot but didn't enact much there. What they did enact are some of those rules that have been put on hold for comment or quashed by the Biden folks.

I think the Biden folks are ready to have that discussion in a more deliberate way. And I would hope Congress has that idea as well.

It'd be a shame to give up on progress and push through government price setting policy that is being called negotiation, but isn't.

On prospects of international price indexing

I think the best means for it to occur currently given the mix of personalities, issues and positions is through some sort of CMMI demo. We forget sometimes that [CMMI] is really a research entity. So you would be testing the effect of implementing the international price index on some number of products in some part of the country.

[The Trump administration] wanted it to be more broad reaching — mandatory.

The one thing that I think the Biden administration may do better is the Trump administration's approach — and maybe it was an oversight, but it affected providers, so he got to drug pricing through through a change in provider reimbursement.

I think the Biden team in a demo would potentially look at doing something different. So keeping this spirit of, you know, international price index, but doing it in a way that wouldn't hurt providers, and ultimately, patients. I think that's the opportunity here.

On lack of a pick for FDA administrator

I think that the Biden administration has analysis paralysis when it comes to appointments. All sides of their party like to weigh in and to their credit, but also detriment, they listen to all sides. And so they let perfect be the enemy of the good.

In the case of Chiquita Brooks-LaSure [Biden’s CMS administrator nominee] and Liz Fowler [Biden’s pick for to head CMMI, a position that does not need Senate confirmation], that process work, those are excellent choices, revered by all, across party, across life science industry, etcetera. FDA is a pivotal role. I'd recommend not overthinking it, you know.

On the ACA and Medicare for all

I think the administration is interested in three things: expansion, expansion and expansion. The nomenclature is simple, right? Government subsidized health care is government subsidized health care whether through Medicare for all or generous exchanges. If you make the exchanges more generous, they begin to look the same.

Medicaid is no exception. I think the president wants to expand coverage there as well.

And none of that is necessarily bad. I think the one issue that that we get asked about a lot as a firm, and that personally, I'm interested is an issue that we've been dealing with since the start of the ACA in 2014 and that is the underinsured. The expanded exchange provides more healthcare than this group needs at a cost they can't afford. And that's something that we have to continue to address even as we're, you know, allowing expansion for other groups.

I think we have to listen and look at this group of who makes up the underinsured, and then make sure that we have a product that that meets their needs, and not one that is so slim, even though the cost is low, it's so slim that it doesn't meet their needs if they have an emergency or a chronic condition or so generous, that the cost is too much.

On an overall letter grade

I think in meeting the needs of the country at this point in time, especially around COVID, and secondarily, his meeting his objectives for expansion [of health insurance coverage], and then third, his ideas around reinstating things that worked and were widely regarded, like the Cancer Moonshot, or this idea that's still nascent, but a DARPA-like effort related to cancer and rare diseases and diseases like Alzheimer's and Parkinson's, I would say, a B+, A-.

In terms of sort of overall looking at the needs of, of stakeholders on some of the rest, like we talked about Medicaid VBA. I think, you know, a B, B+.