Removing Barriers to Clinical Trial Access for Patients With Medicaid: A Conversation With Dr. Melissa Dillmon

Removing Barriers to Clinical Trial Access for Patients With Medicaid: A Conversation With Dr. Melissa Dillmon

Clifford A. Hudis, MD, FACP, FASCO

@CliffordHudis
Oct 04, 2019

Editor’s note: Dr. Hudis hosts the ASCO in Action Podcast, which focuses on policy and practice issues affecting providers and patients. An excerpt of a recent episode is shared below; it has been edited for length and clarity. Listen to the full podcast online or through iTunes or Google Play.

I am delighted to be joined by Dr. Melissa Dillmon, the chair of ASCO's Government Relations Committee, and a longtime dedicated ASCO volunteer. We are going to discuss a barrier to clinical trials for patients who have Medicaid, which is the lack of coverage of routine care costs that are associated with clinical trials. This is a topic that we've touched on previously, but today we are going to dive deeper into the issue and explore ways in which we can advocate for better coverage for those who have Medicaid.

CH: Since it's something I know you care deeply about, could you start off at a high level and give us a little bit of background: what are we talking about when we say clinical research and coverage for patients with Medicaid?

MD: Clinical trials provide the best, or sometimes the only, treatment option for our patients with cancer. We live in a time when there is an incredibly rapid pace of development, with new 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.

We know that these patients have financial barriers to accessing basic medical care and preventative services, so this lack of mandated coverage makes it even harder for some Medicaid patients to participate in potentially life-saving treatment trials.

CH: There is often a lot of discussion about what is a routine cost of clinical care and what is a research cost. Can you expand a little bit on which parts of this are covered—or are they all covered—by these requirements?

MD: 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.

CH: The non-routine care costs, which are required only because the participants are involved in a very specific research study, are generally borne by a sponsor, right?

MD: Correct. So perhaps if there is a genomic sequencing, or a special laboratory test that’s required, that's usually covered by the sponsor of the clinical trial because it’s not a routine care cost.

CH: This issue is a little bit of a paradox because it doesn't cost the insurer any more money for a person to be on a clinical trial and to be covered for routine care. The research study is typically covering the non-standard research components of care, right?

MD: 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 saving the insurer that money.

CH: Medicaid is the only major payer not federally required to cover their costs. Yet at the state level, some states have taken half steps or full steps to require Medicaid to cover the costs of clinical trial participation for patients, right?

MD: 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 the guaranteed ability to participate in clinical trials.

CH: I think some listeners may be surprised that you get that big number—42 million. That raises some basic questions about the reach, 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?

MD: 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. 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.

CH: How does this translate into an increased burden for this special population, as opposed to everybody else?

MD: 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.

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.

CH: One of the things that is frequently stated is that if you can't participate in a clinical trial, then you might be missing out on life-extending or life-saving therapy. But there are also more subtle ways that clinical trial participation can benefit the individual. They may enjoy a higher quality of life with some experimental therapies.

The other thing is that we all, as a society, benefit when 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 we all pay, right?

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

Learn more about the CLINICAL TREATMENT Act and clinical trial coverage under Medicaid. Download an infographic about the bill.

Listen to the full podcast online or through iTunes or Google Play.

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