Clinical Trials Won’t Cause Financial Harm for Practices in Medicare Payment Models, Study Finds

Multiple barriers can prevent patients with cancer from enrolling in clinical trials. One can be the concern that putting a patient on study costs more money; if a physician-owned practice is taking part in an alternative payment model (APM), there may be a fear among those making the decision to refer patients to clinical trials that doing so will undermine a model’s savings targets.

To examine these concerns, investigators with Sarah Cannon Research Institute (SCRI) Oncology Partners and The US Oncology Network used data developed during the years of the Oncology Care Model (OCM) to study the effects of trial participation on hospitalization, drug spending, hospice stays, and overall costs within the context of the OCM, CMS’ model for Medicare patients with cancer than ran from July 2016 through June 2022.¹

In 2 abstracts presented during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, investigators led by Ishwaria Subbiah, MD, executive director of Supportive Care Oncology, Health Equity and Professional Well-being at SCRI Oncology Partners presented results based on data from 121,171 patients with cancer who were treated in practices across The US Oncology Network under the OCM from July 1, 2017, to June 30, 2022.^2,3 Data came from 323 practice sites in 11 states.

Ishwaria Subbiah, MD, is executive director of Supportive Care Oncology, Health Equity and Professional Well-being at SCRI Oncology Partners | Image: SCRI Oncology Partners

Findings in both abstracts are described by “episodes,” which were the 6-month periods of care the OCM used to measure spending and quality. The episode framework is retained under the Enhancing Oncology Model (EOM), the successor APM that launched July 1, 2023, and was scheduled to reopen for new applicants July 1, 2024, with key reimbursement changes.⁴

Across the 2 abstracts that SCRI Oncology Partners and The US Oncology Network presented at ASCO, investigators found the following:

• Over 5 years, spending for Medicare beneficiaries with cancer in clinical trials was higher than usual care by $2341 per episode (P < .0001); however, savings when measured against OCM benchmarks were significantly greater among patients in clinical trials than for usual care patients, $4816 vs $826, respectively (P < .0001).2
• Hospital use was greater among patients on clinical trials,2 but observation visits and trips to the emergency department (ED) were no different among patients receiving usual care.2 Drug expenditures were about the same for both groups.3
• Patients on trials were no less likely to enroll in hospice less than 3 days before death, compared with those in usual care (56.8% vs 52.6%), and duration of days on hospice for trials (8 days) vs usual care (9 days). Neither difference was significant.³

For insights on the findings, Evidence-Based Oncology (EBO) spoke with Subbiah during an interview at ASCO. This interview is lightly edited for length and clarity.

EBO: Can you discuss the value of having such a large data set for this research?

Subbiah: It was very important that we have the full picture, that we not look only at any individual slice of data. For this particular initiative, we looked at our OCM data, or practices that were participating in model. The denominator was that every person who had [participated in the OCM] would fall under that model. So by virtue of being something driven by CMS, we were able to capture a critically important and vulnerable population, which is the older adults aged 65 years and above, their experience with cancer and their cancer journey, and how clinical trial participation factored in with other important anchoring elements of the cancer journey. That’s really what brought these particular projects together. We have such a complete, robust view of an older adult’s journey. Let’s understand what’s happening in a data-driven way.

EBO: It’s a very, very big group.

Subbiah: It’s a big group that allowed us to not be as preoccupied with any outliers.

EBO: When it comes to considering a referral to a clinical trial, is there a perception from some community oncologists: What’s going to happen if I add all these costs to my practice? Is that something physicians worry about?

Subbiah: The practices are all independent, so for those who are leading those practices, there’s a level of investment in the health and well-being of the practice as much as it is about taking care of patients and taking great care of their people. So in that way, the work that we do on my team does center on how we can be facilitators to bring clinical trials into the community.

We focus heavily on the administrative burden of clinical trials. We ask: What does it take for the well-intentioned practice to be able to offer studies? Looking at that administrative burden on practices is a very [important] area of work because we know that in order to have that research infrastructure, it requires a substantial investment.

How does offering trials actually impact the elements of care that we think it impacts? It was important to quantify the costs of care; it’s just 1 element where you can take out that perception, put in the data, and then put in the reality. Across both areas of the work from this data set that we presented at ASCO, that’s one of the common threads: 1 abstract was about cost—and getting clarity on the cost of care—and the second project was about perceptions of end-of-life care and the quality of end-of-life care by comparing those who would have participated in a trial vs usual care. So allow us to take out that perception pin and put in the actual data.

EBO: You’ve started with OCM data, because that’s the model The US Oncology Network practices were in for so many years. Now that CMS is going to reopen the EOM, increase the financial incentives, and favorably change 1 risk factor, it could affect whether practices decide to give the EOM another look.4 What can we assume about clinical trials in the EOM based on these findings? Is there applicability of these findings for practices considering the EOM?

Subbiah: I think these findings add another element of “What does the EOM experience mean—implementing it in the real world?” In that way, you have evidence on how the EOM interfaces with a clinical trial being offered in the clinic, and then the patient’s participation in the trial. And that’s an element of real-world cancer care that needed clarity. For APMs, how will they behave in common, real-world care settings? We’re hard-pressed to find an oncology guideline that doesn’t have “consider clinical trial participation” right up there.

Part of these efforts is to make sure that those reading this work and those who work in clinical oncology are thinking about clinical trial participation with the same mindset they have when they are looking at possibly participating in alternative payment models because it shouldn’t be a silo. When you look at it from the patient side, it’s a person, their family, their caregivers, and it’s 1 journey for them. So part of this is taking the holistic view of the patient’s experience and having these dimensions of evidence to help understand the true impact of EOM and [ensuring that] innovation of care delivery, especially in the real-world setting, involves data-driven equity.

EBO: Results for emergency department readmissions always get attention because that has been such a priority for CMS. Can you discuss those findings?

Subbiah: If you call being a trial participant aggressive treatment, that is a perception in and of itself. Except when you pause and reflect on the standard of care alternatives, in the second- and third-line setting, [treatment] may be profoundly toxic compared to the trial. The trial option may actually be toxic, but there’s also the importance of quantifying health care utilization, especially unplanned health care utilization in the context of the different care settings. And so, in that way, what we want to be able to show is this kind of this interplay. Does trial participation actually result in more ED visits? And more importantly, what happens after the ED visits?

This is a population with advanced cancer, and when you’re thinking about unplanned health care utilization, as payers and as regulatory entities, you think of it in the context of end-of-life care or aggressiveness of care toward the end of one’s life. So it was important for us to be able to demonstrate that the answers don’t begin and end with the ED visit; it may be that that touch point with a doctor is what was needed to get plugged in with home hospice or palliative care or other elements of essential care. And in doing so, we were able to show through these findings that hospice utilization and duration of time spent on hospice was no different.

You’re directly countering a perception that trial participation, which is thought of as aggressive, is associated with inferior end-of-life outcomes. The evidence simply doesn’t back that up. In broadening access to clinical trials—getting older adults to be represented on the clinical trials and, frankly, getting all communities represented on trials—we’re going to have to tackle each of the perceptions with evidence. In each case, let’s take a perception and replace it with the evidence from our own backyard. That way, you’re not having to extrapolate findings from a care setting that doesn’t resemble your clinic in any way.

EBO: That’s another benefit of your data set: Not only is it large, but it’s data from the practices that you are working with. Would these findings, then, be more believable?

Subbiah: Exactly. The data are from across multiple practices, parent practices, and multiple locations from 323 clinic locations. By having that footprint, you’re mitigating any biases from just focusing on a single clinic or cancer center. And the data are from across different states as well.

EBO: Now that you have these results, where do you go from here?

Subbiah: As we learn lessons from our own experience, we share that as pearls of wisdom, not a 30-page manifest. You’re talking about clinics with multidisciplinary, expert practitioners in different roles. You want the key points to land as quickly as possible so that the perception is taken out and the data are put back in. And that’s all part of that overarching effort to have broader representation of older adults on clinical trials. It’s about unpacking individual barriers. These individual barriers aren’t just experienced by 1 or 2 people. It is felt across a much broader portion of the population, but these are never barriers that would get a platform on their own. Both within The US Oncology Network and the partnership with Sarah Cannon Research Institute, it’s taking evidence like this that’s generated in the community setting and making the case for streamlining certain elements of study design and implementation. It’s chipping away at the behemoth that is the clinical trial.

References

1. Caffrey M. Amid concerns, will practices take part in the Enhancing Oncology Model? Am J Manag Care. 2023;29(spec no. 4):SP328.
2. Subbiah IM, Indurlal P, Alam N, et al. 5-year multicenter analysis of clinical trial participation and total cost of care for older adults with cancer. J Clin Oncol. 2024;42(suppl 16). Abstract 11013. doi:10.1200/JCO.2024.42.16_suppl.11013
3. Subbiah IM, Indurlal P, Deepak D, et al. Clinical trial participation and end-of-life care among older adults: a multi-center longitudinal observational cohort analysis of 121,717 patients with cancer. J Clin Oncol. 2024;42(suppl 16). Abstract 11181. doi:10.1200/JCO.2024.42.16_suppl.11181
4. Caffrey M. CMS reopens EOM with payment boost, extends model to 2030. AJMC. May 30, 2024. Accessed June 15, 2024. https://www.ajmc.com/view/cms-reopens-eom-with-payment-boost-extends-model-to-2030