How The ACA Subsidy Lapse Could Hurt Clinical Trial Enrollment

By Devra Densmore, CEO and principal, Elevate Advocacy

It's been 60 days since the Affordable Care Act (ACA) enhanced premium subsidies expired. In those 60 days, 1.5 million people discontinued their marketplace insurance plans, and an estimated 3.5 million to 5 million people may become uninsured if the subsidies are not reinstated. This means that potentially one in 10 people in the United States could be without insurance in the coming months.

Beyond the moral and social implications, it means that 10% fewer people will be available to participate in a clinical study, and that should concern us all.

However, the relationship between the ACA enhanced premium subsidies and clinical research isn’t widely understood, and the implications of one on the other may not be fully appreciated. So, let’s get clear on:

• what the expanded subsidies do
• why a lapse in these subsidies will impact insurance coverage
• why fewer insured people could mean fewer clinical trial participants
• what clinical teams can do to mitigate this risk.

What The Expanded Subsidies Do

In the U.S., there are two types of insurance, public and private. When a person does not qualify for public insurance (Medicaid or Medicare) or cannot access private insurance (typically through an employer), then they seek insurance coverage from the Affordable Care Act marketplace. Policy analysts often describe it as “a last resort,” although nearly 7% of the U.S. population relied on the marketplace to access affordable health insurance.

Until December 31, 2025, the ACA had expanded subsidies (also known as an enhanced premium tax credit or ePTC) that lowered the cost of insurance premiums by removing the upper income limit for eligibility of the tax credit that allowed uninsured individuals and households to ostensibly afford the premiums of marketplace health insurance.

According to Kaiser Family Foundation, the average premium rose $888 in 2025 to $1,904 in 2026. For context, that’s more than

• a 100% increase
• the average rent for a two-bedroom apartment
• the average mortgage payment in December 2021.

Why A Lapse In These Subsidies Will Impact Insurance Coverage

When insurance premiums skyrocketed, 1.5 million people had to make the difficult choice to drop their health insurance. Millions more downgraded their plans to lower their premiums, resulting in less coverage and higher out-of-pocket costs. For people living with health conditions and who might be eligible to participate in a clinical trial, this means that the cost of care burden falls more to them.

Why Fewer Insured People Could Mean Fewer Clinical Trial Participants

Health insurance, whether private or public, covers certain costs associated with a clinical trial. Most clinical operations professionals or principal investigators know this from the Medicare Coverage Analysis they must apply to their clinical trials prior to going to the IRB.

According to Sachit Verma, MD, MBA, FAPCR, Medicare Coverage Analysis (MCA) "is a uniform methodology of analyzing the items and services provided in a clinical research study, i.e., a comprehensive review of protocol documents that helps identify the appropriate payor (sponsor or third party) for each study service, assessment of the protocol driven items and procedures that can be billed to either insurance, as routine cost, or as costs billable to the study sponsors."

It is important to note that the Centers for Medicare and Medicaid Services’ (CMS), National Coverage Determination (NCD) on routine costs in clinical trials applies to Medicare beneficiaries. Private insurance coverage is governed separately, primarily under ACA clinical trial coverage provisions and individual payer policies. Although CMS does detail in the NCD which protocol-required routine costs are covered, there is nothing explicit stating if a person will consistently receive coverage on anything required outside that list or who will cover those costs.

What may be misunderstood is that CMS does not consider routine costs and standard of care to be the same thing and, therefore, does not cover both equally — or in the case of standard of care — may not cover it all unless deemed “medically necessary” and meets certain scientific and ethical standards. While CMS covers routine costs in qualifying clinical trials, including many services that would otherwise be considered standard-of-care treatment outside the trial, when it does not, that cost falls to the sponsor or the site.

Therefore, if you as a sponsor are conducting a multi-arm study, and one of those arms requires standard of care to be administered, and all or part of the standard of care is not considered “medically necessary” those costs will be passed along to the site or to the study participant. If those costs are not part of what the sponsor provides to the site to conduct the study, study participants who do not have private insurance to cover those costs could be disqualified from the study so that the site does not have to absorb those costs.

As the sponsor, you may or may not be aware of the rationale behind screen fails, but it is possible that some may be attributable to patients being uninsured or underinsured. This means that some of the delays in your trial’s recruitment efforts may be due to a lack of insurance coverage. In fact, a leading oncology center of excellence — one that conducts more than 1,250 trials and enrolls more than 10,800 study participants in a year — has a policy that standard of care costs will not be absorbed by that institution. Therefore, if a study participant does not have insurance coverage, they may be deemed ineligible for the study due to issues around “financial feasibility.”

As trial sponsors seek to have more representative studies that include rural, lower income, or other marginalized populations, lack of insurance coverage might be a key barrier for those individuals to opt into a clinical trial.

What Can Clinical Teams Do To Mitigate This Risk?

First, a development team must understand how this policy may impact them. Clinical teams, particularly those in smaller biotech companies that do not have the market access or government affairs function, should invest in a policy expert to help identify policies that could have an impact on their program’s success — positive or negative.

Second, when creating an MCA, the sponsor must understand what in the protocol will be classified by CMS as routine versus standard of care. If you are not sure what is covered, CMS provides a list of "routine costs" in clinical trials.

Third, if you as a sponsor outsource the MCA or do not have a direct role in completing one, it would benefit you to become familiar with it. An excellent article and guide for clinical program teams can be found on the Society of Clinical Research Associates' (SOCRA) website: Medicare Coverage Analysis - A Billing Compliance Perspectives - SOCRA Blog.

Fourth, if many procedures or elements of your protocol will not be covered by CMS, you must understand the policies of your sites. Will any or all your sites disqualify otherwise eligible participants from the study? Are you willing to lose those potential subjects? What will the costs be for delayed recruitment or lack of representation? These questions are essential to determine how much risk you may assume in the process.

Fifth, determine if you cover any part of the protocol that might expose you to recruitment or retention risk in your clinical development plans. Remember, although 1.5 million Americans no longer have ACA insurance, in the coming months and years, up to 5 million may have to forgo coverage, thus increasing the uninsured to 15% of the U.S. population. This may lead to retention efforts if a participant loses or drops coverage partway through the trial.

Sixth, explore with patient advocates, patients, and caregivers the essential parts of a trial to cover — just as you would in your minimum and target product profiles, exploring with your end user (i.e., study participant) what they are willing to accept or make trade-offs on helps you understand where risks might lie that are not obvious to you or others designing the study. From there, you can clearly identify what you may wish to invest in and assess how those costs might save potential downstream costs related to delayed recruitment or other issues in successful trial execution.

Improving The Potential For Success

Strategic planning in clinical research includes looking beyond your most immediate needs and incorporating key information that may help accelerate your plans in the near and long term. Although public policy may seem like it’s important to functions outside of R&D, the impacts of those policies on the success of clinical research can be profound. It’s up to clinical development leaders to zoom out beyond the program team to identify potential risks and barriers that could negatively impact the future of their trials, assets, or company’s future.

About The Author:

Devra Densmore is CEO and principal consultant at Elevate Advocacy. Over her 20 years of patient advocacy and engagement experience, Devra has driven patient-focused drug development globally by assessing, operationalizing and measuring patient insights to optimize clinical trials in rare and common disorders. She and the team at Elevate Advocacy have also influenced treatment algorithms in hospitals and clinics to decrease rehospitalization and improve outcomes and advocated for community-led health programs and policies affecting millions of people.