A ruling from a judge in the US District Court in the Northern District of Texas has raised questions about one of the most popular elements of the 2010 Affordable Care Act (ACA), which requires most private health plans to cover preventive services without cost sharing from members. On March 30, 2023, Judge Reed O’Connor, ruling in Braidwood Management v. Becerra, found that the ACA’s use of the US Preventive Services Task Force (USPSTF) to determine whether services merit an “A” or “B” rating—and are thus eligible for coverage without cost sharing—violates the Constitution’s appointments clause.1 The US Department of Justice has requested a stay on the ruling while it is being appealed, but the episode nonetheless creates uncertainty around the availability of services such as lung cancer and colorectal cancer screening that have expanded since 2010.2
In this interview, we speak with 2 University of Michigan faculty members: Professor of Law Nicholas Bagley, JD, with the Institute for Healthcare Policy and Innovation; and Professor of Internal Medicine and Professor of Health Management and Policy A. Mark Fendrick, MD, who is director of the University of Michigan Center for Value-Based Insurance Design. Fendrick is co-editor in chief of The American Journal of Managed Care®. Bagley addresses the legal and Fendrick addresses the clinical implications of the ruling. This interview with Evidence-Based Oncology™ (EBO) has been edited for length and clarity.
EBO: Professor Bagley, can you give us some background on the Braidwood case?
Bagley: The lawsuit arose as part of a challenge to a really important feature of the Affordable Care Act. The United States thought it was important to make preventive services available to people with $0 cost sharing, meaning they don’t pay anything out of pocket…. The way the ACA was structured handed off to a series of independent bodies the authority to designate certain preventive services that insurers and employers would have to cover with $0 of cost sharing. The challengers in the case that is now known as Braidwood filed suit in Texas in federal court and argued that the scheme that Congress established is unconstitutional. They have a several different arguments, including a religious liberty claim. The one that I think poses the biggest threat to this feature of the ACA is…something called the Appointments Clause. The Appointments Clause is a pretty obscure provision of the US Constitution; simplifying a bit, the Appointments Clause says that legally significant decisions have to be made by federal officers who are appointed by the president, or by the head of a department. And the reason for this is [to establish] a very clear chain of command when the executive branch is making important decisions for people’s lives: you want to make sure that the people making those decisions are answerable in some way or form to the president. You don’t want Congress to be able to delegate power to some random person on the street and have them make important decisions for the rest of us. It’s a way to maintain accountability. And the challengers said that with several of these bodies, the people who stacked them weren’t appointed in the right way.
EBO: What did the judge say about the Appointments Clause?
Bagley: The judge in Texas said that the appointment of the individual personnel to 2 of those bodies was generally proper. And so, provisions of the ACA that require coverage of certain vaccines [Advisory Committee on Immunization Practices] and health care for adolescents and for women [Women’s Preventive Services Initiative]—those are going to be OK.3 But [the judge found] that members of the US Preventive Services Task Force, or USPSTF were not appointed in the right way. Constitutionally, they can’t make decisions; thus, the USPSTF recommendations that employers and insurers are supposed to follow in providing $0 coverage for preventive care—those USPSTF decisions are unconstitutional. And the judge extended that ruling across the entire country; he said that it doesn’t just apply to the plaintiffs who filed a lawsuit, but it applies to everybody. And that, of course, set off an effort to pause his decision, while appeals could work their way to the US Supreme Court.
EBO: So, what happens now? Will we see changes right away?
Bagley: The decision isn’t going to have an immediate automatic impact, and that’s for a couple of reasons. First, and most importantly, I think most employers and insurers are…in a watching and waiting mood; they’re looking to see what’s going to happen with this case on appeal. Very few, if any, are making sweeping changes to their coverage…. Even if the plaintiffs win, there will be a relatively small number of employers that [significantly] change up what they’re doing. But there’s a fair amount of uncertainty around that…. The government has already appealed the judge’s decision and asked the US Court of Appeals for the Fifth Circuit to put a hold on his decision while the Fifth Circuit considers it. That effort to get a stay pending appeal has been opposed by the plaintiffs, who are also going to take an appeal of their own. But in the meantime, right now, we are mostly in a waiting mode. The longer this drags on, the more employers and insurers may decide that they want to try to change their offerings. But for now, it seems that their response has been pretty modest.
EBO: Is there anything Congress can do?
Bagley: [Regarding] the scheme that Congress devised here, the judge said that arrangement of having USPSTF make the important decisions contravenes the Appointments Clause of the US Constitution. But, of course, Congress is free to change up how it delegates authority to make these appointments. So it’s perfectly within Congress’s power to fix the statute. And what it could say is something like, “Subject to approval by the Secretary of Health and Human Services, the USPSTF makes certain recommendations about which guidelines have to be covered.” And if Congress were to make that change, which would be quite modest, it would eliminate the basis for the plaintiffs’ case, and end the case long before we had to deal with the inevitable.
In terms of what the state governments might do, several states, including my state of Michigan, have moved to require insurers to cover the preventive services that USPSTF has designated at $0 of cost sharing. And here in Michigan, the insurance industry has lined up behind that and said, “Sure, we’re happy to go along with that.” The challenge for states is that those decisions only apply to a small slice of the overall insurance market. If you buy your insurance through the exchanges, you’re going to be covered by the effort on the state’s part to extend preventive coverage. But if you work for an employer that self-insures, which means an employer that pays out of its own pocket, [you are not helped]. States can only protect a quarter to a third of their residents. This is really something that’s the federal government’s mess to clean up.
EBO: What can be gained from engaging with legislators, policy makers, and the general public on this issue?
Bagley: If you’re speaking to Congress, you say, the preventive services mandate is an extremely popular part of the ACA; it’s a part of the ACA that has reached more than 150 million Americans. It is not a controversial provision; it’s not caught up in the hot button battles over whether or not the ACA should have existed. It’s just about providing high-quality preventive care and shouldn’t be a partisan issue. It should be something that we can get agreement on across the aisle for a legislative fix.
In terms of the message to the public, it’s that there could be some changes potentially coming down the pike. It won’t happen right away, but it is a concern. And we should be demanding from our elected representatives that they make good commonsense decisions about coverage of preventive services. Nothing stops Congress from fixing this in my view, so fix it.
EBO: Dr Fendrick, can you discuss the clinical implications of this case? What would happen if patients lost access to preventive screenings without cost sharing?
Fendrick: It’s been very challenging, having been involved with the preventive care mandate of the ACA from the beginning, to see this challenge, given the profound effect it has had on millions of Americans. Our own analyses, and others, have shown that the impact regarding access to these potentially lifesaving preventive services [is] disproportionately benefited by underserved populations, communities of color, low-income individuals, and those who live in rural places.4,5 I think there have been some public health advocates who’ve talked about a specific aspect of this case, in the fact that it’s allowable and actually mandated that any USPSTF recommendation [made] before the signing of the ACA in March of 2010 must stay in place. And I have, as a clinician and someone who’s been following this very closely, some reservations about that, given that there are now 46 services that have an A or B rating by the taskforce; thus, the requirement of zero cost sharing for these services.
Interestingly, 15 of these have been designated an A or B rating since 2010. Some of them, for the first time, such as anxiety screening and preexposure prophylaxis (PrEP) for HIV, have received a lot of attention. But there are also some of these services that have been upgraded from a non–A and B [rating] to an A and B, like lung cancer screening, which is now a very popular and very effective intervention that is covered with zero cost sharing.
I think it’s also important to point out that 17 of these 46 [services] have been changed substantially [since 2010]. This means either the populations that are impacted have changed, or the modality of the preventive service has changed. An example where that has happened in both is colorectal cancer screening. Colorectal cancer screening, and its last iteration [in the USPSTF recommendations], not only included a [recommended] change in age to average-risk people between 45 and 49 [years], which is 20 million Americans who now have access to no-cost colorectal cancer screening, but the updates since 2010 also include new interventions such as stool DNA testing, which is a noninvasive way to screen for colorectal cancer.6,7 So when you see that either populations or modalities have changed, or a new A or B rating has occurred since 2010, that covers almost two-thirds of the 46 services. That leaves 14 of the 46 that have basically remained unchanged. For those who are thinking, ‘Oh, it’s OK,…we’re going to be able to just keep these older recommendations,’ I think those people are underestimating the clinical impact of this Braidwood ruling.
The other thing I want to mention is that one aspect of the way this small section of the ACA that I helped work on is written is that it’s a gift that keeps on giving. So it’s not like this list exists from 2010. It is these 3 organizations that Professor Bagley mentioned, and, most notably, the USPSTF continues to work on well over a dozen different preventive services at one time, 6 of which actually have draft A or B ratings now, including anxiety screening and intimate violence and other types of services that are likely to get an A or B final rating. But if this legal decision were to hold, the services would not be mandated to have zero cost sharing.
While I am confident––and our own research shows that many payers will probably stick with the services that currently have an A or B rating and not change them, although 20% say they may not––I’m particularly worried about the gift that keeps on giving in the fact that I’m less confident that payers will continue to embrace zero cost sharing for new services that have A or B ratings.
And the last point that I think is worth mentioning is that many people do not know that it was actually the preventive care section of the ACA that was amended to allow zero cost sharing for COVID-19 testing, vaccines, and treatments. And [because] we didn’t even know what COVID was until long after 2010, if this lawsuit [were to] be upheld, the current status of zero cost sharing for COVID diagnostics, vaccines, or treatments [would be] likely to go away. So I do have concerns, particularly [as] our own review of the literature of these programs that have eliminated cost sharing has shown disproportionate positive benefit for underserved populations, I do worry about the equity implications of, what I like to say, going back into the future and seeing some of these older recommendations being adopted as opposed to the newer ones, or even worse, having the newer ones being completely eliminated.
I am hopeful to work with a very strong multi-stakeholder coalition to bring the benefits and the merits of restoration of the preventive care provisions of the ACA and have the legal language that Professor Bagley has helped us all with be approved. And we could go back to where we were, such that 150 million Americans at least, not including the COVID[-19] beneficiaries who have benefited from this very tiny section of the ACA, will continue to be able to have unfettered access to evidence-based preventive services moving forward.