Removing Barriers to Clinical Trial Access for Patients with Medicaid

ASCO in Action Podcast

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Dr. Melissa Dillmon, the Chair of ASCO's Government Relations Committee, joins ASCO CEO Clifford A. Hudis to discuss improving access to clinical trials for patients with Medicaid. Medicaid covers 20% of Americans, however unlike Medicare or private insurers, Medicaid is not federally required to cover the routine care costs associated with clinical trials.

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Transcription Shannon McKernin: Hi. My name is Shannon McKernin, and I am the host of the ASCO Guidelines Podcast series. When a new ASCO guideline publishes, we release a podcast episode featuring an interview with one or more expert panel members. Each episode highlights the key recommendations and the implications for patients and providers.

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Clifford Hudis: Welcome to this ASCO in Action podcast. This is ASCO's monthly podcast series where we explore policy and practice issues that impact oncologists, the entire cancer care delivery team, and most importantly, the individuals who care for-- people with cancer. My name is Clifford Hudis, and I'm the CEO of ASCO, as well as the host of this ASCO in Action podcast series.

For today's podcast, I am really delighted to be joined by Dr. Melissa Dillmon-- Missy-- the chair of ASCO's Government Relations Committee, and a longtime dedicated ASCO volunteer.

Now, regular ASCO in Action podcast listeners may remember that just a few months ago, I spoke with one of our colleagues, Dr. Beverly Moy, the issue of financial barriers to clinical trial participation, and we focused on ASCO's work to address those barriers to try to make it easier for patients to enroll in clinical research studies.

Today, we're going to follow up on that. Dr. Dillmon is going to join me as we drill down deeper into one of the barriers that we've touched on previously-- in this case, the lack of coverage of routine care costs that are associated with clinical trials, but very specifically, the challenges that are faced by patients who have Medicaid.

Dr. Dillmon, welcome, and thank you for joining us today.

Melissa Dillmon: Thank you, Cliff, for having me and discussing what I think is a very timely and important issue.

Clifford Hudis: Since it's something I know you care deeply about, maybe you could start off at a high level and give us a little bit of background. What is it exactly that we're talking about here, when we talk about clinical research and coverage for patients with Medicaid?

Melissa Dillmon: So Cliff, you know that in many cases, clinical trials provide the best or sometimes the only treatment option for our patients with cancer. And we live in a time when there is an incredibly rapid pace of development, with new investigational treatments that are dramatically altering the course of cancer for the better. Patients with Medicaid have a unique barrier to accessing clinical trials because Medicaid is the only payer that is not federally required to cover the routine cost of clinical trial participation.

So Medicare and major commercial payers are required to have coverage for routine costs of clinical trial participation. Medicare provided this coverage beginning in the year 2000 after the Medicare National Coverage Determination Act protected their beneficiaries. The Affordable Care Act also requires insurers to cover routine patient care costs for trials participation. But Medicaid was not specifically called out or included in this requirement.

So today, commercial payers and Medicare are paying for the routine cost of clinical trial participation, but Medicaid is not required in any of the states by the federal government to cover these costs. And we know that these patients have financial barriers to accessing basic medical care and preventative services anyway. So this lack of mandated coverage makes it even harder for some Medicaid patients to participate in potentially life-saving treatment trials.

Clifford Hudis: I remember from, obviously in my days of doing clinical studies, there was often a lot of discussion about what was a routine cost of clinical care and what was a research cost. Can you expand a little bit on which parts of this are covered, or are they all covered, by these requirements?

Melissa Dillmon: So routine care costs are the regular doctor's appointment or E&M charge, radiology exams, drugs to manage side effects, supportive care medications, laboratory tests. It is not the cost of the drug or anything specifically related to that, it's just the routine care costs that go along with cancer treatment care, whether that patient was on a trial or on a regular, on-label drug.

Clifford Hudis: And in an ideal world, when this is working efficiently, this dovetails neatly with the fact that the non-routine care costs-- those things that are being required only because the participants involved in a very specific research study-- those costs are generally borne by a sponsor, right?

Melissa Dillmon: Correct. So perhaps if there is a genomic sequencing that was required, or a special laboratory test to assess a response in a marker that was not a routine care cost, that's usually covered by the sponsor of the clinical trial.

Clifford Hudis: And so just to make sure every listener is following, the irony here is without this requirement, in a sense, a person with good commercial insurance historically could find themselves not covered for the exact same costs that normally would have been covered solely because they're getting some treatment that is part of a clinical trial. And that seems like a perverse incentive in the wrong direction for all of us across all of society, right?

Melissa Dillmon: Exactly, especially at a time when it's challenging to get enough people on clinical trial, and we're trying to get more people on clinical trials. We're trying to remove those barriers.

Clifford Hudis: Right, and I would go even a step further and say it's a little bit of a paradox because it doesn't actually cost the insurer any more money for a person to be on a clinical trial and be covered for routine care. It's not as if they're getting an increased charge back because the patient's on a clinical trial. The research study is typically covering the non-standard research components of care anyway, right?

Melissa Dillmon: Correct. And then oftentimes, if there's an investigational drug, they're taking the cost of the drug out of the picture. So in some ways, you're actually saving the insurer that money.

Clifford Hudis: So it's funny, as well, a little paradox that Medicaid is the only major payer not federally required to cover their costs. Yet at the state level, I think-- and I just heard about another one today, I'll tell you-- some states have taken half steps or full steps to require Medicaid to cover the costs of clinical trial participation for patients, right?

Melissa Dillmon: That's correct. About a dozen states have taken action, through written statutes, or regulations, or policies, to require their Medicaid plan to cover these costs. But that's only a dozen states. That leaves about 42 million Medicaid patients who do not have guaranteed ability to participate in clinical trials.

Clifford Hudis: You know, I think some listeners may be surprised that you get that big number-- 42 million. And of course, that raises some basic questions about the reach, and scale, and extent of Medicaid. I think we should talk about that for a moment. So who has Medicaid as their primary insurance? That is, who is covered by Medicaid-- what kinds of patient populations and so forth?

Melissa Dillmon: So Medicaid covers about 20% of Americans. Patients on Medicaid are often lower income. It's usually children, older adults, patients with disabilities, and some patients in rural areas are more likely to have Medicaid. So depending on where those dozen states are that have those statutes, those may be states that don't have as large rural populations or lower income patients.

So racial and ethnic minorities are also overrepresented in Medicaid. For example, African-Americans represent about 12% to 13% of Americans, but 21% of patients receiving Medicaid are African-American. Hispanics represent 18% of the American census population, but 25% of patients on Medicaid are Hispanic.

Clifford Hudis: So this is the same old issue, where certain racial features, as it were, are surrogates for lower socioeconomic status, and that's what you're describing, unfortunately. Right?

Melissa Dillmon: Correct.

Clifford Hudis: OK. And so we take this group of patients that are, in general, a little bit disadvantaged-- lower socioeconomic status as an average, perhaps more rural, which itself represents a barrier to care-- and then you add on the limitation in terms of clinical trial participation coverage. So how does this translate into an increased burden for this special population, as opposed to everybody else?

Melissa Dillmon: Well, we already know that cost is a major barrier to participation in clinical trials. Patients who have larger income are more likely to participate in clinical trials, or be offered a clinical trial, or live in an area where there is a clinical trial available for them. Patients who have a lower income-- less than $20,000 per year-- have a much lower participation rate in clinical trials, and we are therefore missing a lot of patients who could be benefiting from those clinical trials and who could be contributing to the science.

And these patients don't have the financial resources to pay for their routine cost of care. They cannot afford to pay the E&M visit, or for a chest x-ray, or a CAT scan on their own. So that would pose a huge barrier for them to even consider participating in a clinical trial.

And one of the things that frequently is stated is, of course, this means that if you can't participate in a clinical trial, that they might be missing out on life-extending or life-saving therapy. And we have to admit that that, of course, is uncommon, but not impossible. But there are also more subtle ways that clinical trial participation can benefit the individual.

Clifford Hudis: They may enjoy a higher quality of life with some experimental therapies sometimes. And the other thing, of course, is that we all, as a society, benefit it clinical research studies are concluded more quickly. We get an answer faster and we can move on to the next big thing or build upon what we've learned. So it isn't as if the cost of this is limited solely to people with Medicaid. It's something, I guess, we all pay, right?

Melissa Dillmon: As a society, I think we suffer when patients are not able to participate in these studies.