♪♪[music]♪♪ You are listening to ‘The Operative Word,’ a podcast brought to you by the Journal of the American College of Surgeons. I'm Dr. Jamie Coleman. And throughout this series, Dr. Dante Yeh and I will speak with recently published authors about the motivation behind their latest research and the clinical implications it has for the practicing surgeon.
♪♪[music]♪♪ The opinions expressed in this podcast are those of the participants and not necessarily that of the American College of Surgeons. ♪♪[music]♪♪ Welcome to the Operative Word, a podcast from the Journal of the American College of Surgeons. I'm Dr. Dante Yeh.
One of your co-hosts for the series. In this episode we’ll be taking an in-depth look into the current article ‘Comprehensive Cost Implications of Commercially Available Noninvasive Colorectal Cancer Screening Modalities.’ I'm honored to be joined today by the first author, Dr. Casey Allen, M.D., from the Allegheny Health Network in Pittsburgh, Pennsylvania. Dr. Allen, thank you for joining me today. Before we begin, do you have any potential conflicts of interest to disclose?
Good evening, Dr. Yeh. Happy to be here. No conflicts of interest on my side. All right, well, let's start with can you give us a brief summary of your study design and describe to us your main findings? So in light of the rising trend towards noninvasive colorectal cancer screening, our research focused on understanding the long term cost implications of two common modalities the Fecal Immunochemical Test or FIT and Cologuard.
We analyzed over 119,000 patients using a national insurer based administrative data set and integrated it in with our own granular clinical data set. We found over $13 million are spent annually on these two noninvasive modalities within our payor network alone. However, by exclusively using FIT, we found that health care systems could potentially save millions of dollars annually, reducing our own $13 million spend to about half saving nearly $6 million a year within our own system alone.
Moreover, early stage detection rates were comparably high for both tests, ensuring equal efficacy of these modalities. But honestly, it's not so much about those important findings and the potential value implications to a large health system. It's also about our novel analytic approach. In today's era of value based health care decisions are heavily influenced by insurance companies.
What sets our research apart is the unique collaboration between clinician researchers and experts from the payer sector. And by combining their data analytic strengths through our academic lens, we created a resource that stands to benefit many in the medical community. These partnerships where payers, providers, patients, other stakeholders collectively steer the trajectory of care delivery, can provide novel value based insights All right, great.
So I'm not going to tell you my age, but I'm staring down the barrel of my first colonoscopy. So I'm very, very interested in these noninvasive screening modalities. I'm not really familiar with some of these newer, noninvasive screening modalities. So I was hoping you could describe to me, how does the fecal immunochemical test and the Cologuard work?
So the fecal Immunochemical test or the FIT test and Cologuard are both noninvasive colorectal cancer screening modalities, but they function quite differently. FIT works by detecting occult blood in the stool. It specifically targets human hemoglobin in the lower intestines of a colon. The test is done by taking a small stool sample and then using antibodies that are sensitive to the blood Proteins present.
The major advantage of FIT over other stool based tests is that it does not react with red meat or vitamin C, so there are fewer dietary restrictions and thus fewer false positives from the diet. Cologuard, on the other hand, is a multi target stool DNA test. It combines both the detection of occult blood, much like FIT with the identification of certain DNA mutations such as KRAS that are shed into the stool from precancerous polyps or cancers.
When we talk about accuracy, both FIT and Cologuard have a similar positive and negative predictive value. And so is it safe to say also that the accuracy is similar between the FIT and the Cologuard? Yes, essentially the accuracy is very comparable between the two testing modalities. And I think I remember that if you have a negative screening colonoscopy, you're good to go for ten years, right? That's right. That's right. How often do you have to do the FIT or the Cologuard?
Is it also once every ten years? No, the FIT test is an annual test. And the Cologuard is every three years. So that basically is what determines some of the cost implications. So you might be having a cheaper test with the FIT or Cologuard less intervals, but a higher price. But it's not every ten years like the colonoscopy. And how much stool do I have to collect and do I have to store it in my fridge next to all my food?
It's a small amount of stool, and I don't think you have to store it next to your food, but it is a relatively small sample. Yeah. Okay, good. Good to know. Good enough. All right. And you briefly mentioned this in your study, but I know it wasn't the focus of your study, but how did these two noninvasive modalities compare to other noninvasive modalities such as CT colonography?
Yeah. So comparing these modalities to other noninvasive modalities, as you mentioned, there's the fecal occult blood test. This test, the positive predictive value and the negative predictive value of the fecal occult blood test are quite similar to FIT, but might be a little bit lower in terms of sensitivity, especially when considering adenomas or early stage cancers.
And additionally, the fecal occult blood tests can be influenced by diet and medications, which can lead to more false positive results. The CT colonography, also known as the virtual colonoscopy, uses CT scans to produce images of the colon and rectum.
Its sensitivity is quite high, often comparable to traditional colonoscopy, especially if its detecting a larger polyp or cancer by the neg- But the positive and negative predictive value can vary greatly, and one major limitation is that if a polyp or a suspicious lesion is detected, then you’re basically required to undergo a traditional colonoscopy. And that is basically an unnecessary test on that, in that matter.
And you're supposed to undergo a traditional bowel preparation before you do a CT colonography, correct? Yeah. Do you have to also do a bowel prep, using the FIT or the Cologuard? No, no, those don't require a bowel prep.
Got it. Okay. I think I have an understanding now of these other modalities in your paper in the introduction, you state that the United States Multi Society Task Force or USMSTF, has issued guidelines on the use and effectiveness of noninvasive screening modalities, and that this task force actually recommends FIT as the primary noninvasive screening method because of its lower cost compared to Cologuard. But how strong is the evidence supporting these guidelines?
Is there high level evidence or is this expert based opinion? So the United States Multi Society Task Force or the USMSTF is a collaborative effort among several GI societies in United States. Their guidelines are developed through a pretty rigorous process involving systematic reviews of available evidence, consensus building among experts, and they regularly update their guidelines based on new evidence. So generally, the strength of evidence is typically very high.
The task force did recognize fecal occult blood test, as is recommended as a modality for colorectal cancer screening for several years. But they recommend FIT, as I mentioned, because there's data supporting from multiple large studies that FIT over fecal occult blood test is better due to its higher sensitivity for cancer, fewer dietary restrictions
and better patient adherence. Similar to the CT colonography, It is acknowledged by the task force as an option for screening and for certain patients, it's appropriate. However, they again, note that there are potential downsides include, including the fact that any significant finding would require a traditional colonoscopy.
Thus putting the patient at radiation, unnecessary radiation exposure from the CT colonography, and then also the possibility of incidental findings outside the colon that may require further testing that is not cost effective or cost indicative. You've already mentioned a couple of times that after a positive CT virtual colonoscopy, you would need to follow up with a traditional colonoscopy.
Is that also true for both FIT guard and Cologuard, if it comes back positive and if both tests have high positive predictive value, what would you do next? Yeah, no, absolutely. Any these are screening modalities. I think that the thought is that with the CT colonography, it's essentially a, it's a procedure of sorts. It's a radiologic procedure requires exposure and it's a high cost test.
So that in addition as a screening modality and the potential for acquiring yet another procedure just to confirm potential findings makes it less preferable against other modalities. All right. So let's take a look. So in table 1, you give a breakdown of the different screening modalities and the number of members and also the percentages it looks like far and away the most common modality in this health system was traditional colonoscopy at 89.6%. I see a fecal occult blood test was 1.9%.
Flexible sigmoidoscopy was 0.9%, and CT colonography was only 0.1%. FIT was 3.6%. And Cologuard was about the same at 3.8%. So there are, the task force guidelines out there. But it seems like there's a little bit of all the noninvasive modalities. This is I believe this is probably the most commonly being done by primary care practitioners doing screening. What would in your opinion, why would a PCP choose one noninvasive screening modality over another?
So a lot will depend on the patient, depend on what their comfort level is. Though the primary care provider might provide the risk and benefits and potential advantages and disadvantages to any of these modalities? I think a lot of patients recognize that colonoscopy is the gold standard, and any test that requires that, any test that ends up becoming positive, it would require colonoscopy anyway. A lot of patients simply go straight for the colonoscopy.
The FIT or Cologuard or fecal occult blood test, a lot has to do with the capabilities of the clinic itself. So for the FIT, a lot of the test results need to be interpreted by the physician or the physician team. However, Cologuard is more of an internal it's more industry and it's analyzed more by the by the company itself. And that reduces a lot of the overhead for the patient or excuse me, for the provider itself. So a lot of the times it's just logistics.
It's based on the capabilities of the clinic and it depends on the preference of the patient. All right. Got it. Yeah. Your study only included patients over the age of 50 years old. Can we extrapolate these same findings and conclusions to younger patients or high risk patients like those with ulcerative colitis or other genetic disorders? That's a great question.
I think it's important to recognize that our study specifically focused on patients greater than 50 years because this age group has historically been the target for routine colorectal cancer screening. However, the American Cancer Society recently updated its guidelines to recommend routine screening for colorectal cancer starting at age 45 instead of 50. Because for those at average risk, because there's data supporting an uptick in colorectal cancer rates among these younger adults.
Now, while noninvasive modalities like FIT and Cologuard can be used in these younger populations, it's important to individualize the screening approach. Some younger individuals may prefer noninvasive screening, while others might opt for traditional gold standard colonoscopy, especially if they have other risk factors or symptoms.
And in terms of patients that are at high risk for colorectal cancer, such as those with inflammatory bowel disease like ulcerative colitis or other genetic syndromes like Lynch syndrome or FAP, typically a more aggressive and tailored screening approach is needed. Routine colonoscopy at younger age and more frequent intervals is usually recommended due to this significantly elevated risk of developing colorectal cancer in this population.
It's also important to note that in patients with inflammatory bowel disease, in addition to detecting cancer, there's other important considerations, such as assessing the extent and severity of their disease, which isn't assessed with these noninvasive testing modalities. Thus, typically noninvasive screening modalities might not offer the comprehensiveness of what these high risk patients require. Yeah, you make a good point about that. I'd forgotten about that. All right, great. Great.
Can you describe to me the hierarchical logic structure? I'm not really familiar with the term, and I was hoping to get a better explanation about it. Yeah, honestly, I learned a lot from the High Mark analytic team. They have several actuaries that assess how we determine what patients treatments and testing modalities are actually performed using claims data when we don't have the actual direct evidence from the EHR.
So the hierarchical logic structure used in our study was a structured method to classify patients based on their screening methods, ensuring accuracy in understanding the actual sequence and reasoning behind their screenings. So our first step was to distinguish between those who underwent a colonoscopy as their primary evaluation and those and determined those who had it as a follow up to noninvasive tests.
So we did this by identifying patients who had a colonoscopy before a colorectal cancer diagnosis. In these patients, we reviewed their history over the preceding six months to check to see if they had undergone any noninvasive screening modalities. This included C.T. colonography, fecal occult blood test, FIT, or Cologuard.
And if a claim for noninvasive test was discovered in this six month review prior to their diagnosis of colorectal cancer, we classify them as those who underwent noninvasive screening. If we didn't find any claim for a noninvasive test in those that were diagnosed with colorectal cancer, we classified them as the colonoscopy group because no invasive test, no noninvasive test was performed.
And they and they had to undergo a diagnostic colonoscopy for their to diagnose their cancer for the rest of the population that was not diagnosed with colorectal cancer. We basically classified them into the screening group based on their most recent screening method that they had undergone. So colonoscopy, fecal occult blood test, FIT, or Cologuard.
So it's a little complicated, but that's how we derived what that hierarchical logic structure was, how we derived, what the primary screening modality for each patient was. All right. Yeah, it sounds pretty straightforward now that you explained it that way. Yeah, I. I think it makes sense. Um, you mentioned in your manuscript that the FIT has two distinct Medicare codes. Why are they associated with different costs?
Having two distinct Medicare codes is really just more reflective of the nuances in how medical billing and coding systems can often categorize procedures, test interventions. So there's different FIT kits. There's different FIT kits or procedures that might have varying methodologies or materials used. This can lead to differences in costs associated with the test, but it's due to the complexity of the methodology, the reagents used, or other factors.
Some FIT tests, however, might require samples from multiple days, while others might just need one. And moreover, the manner of interpretation or the technology use to read the results could differ as well. So these distinctions can lead to variations in the cost structure.
So one code might encompass a more comprehensive service, and another might encompass elements such as patient consultation, data interpretation, or even follow up care, while others might simply cover the cost of the test itself. I see. And you mentioned earlier that the ordering provider has to interpret the FIT results themselves.
Is that right? Yeah. Yeah. And I can see how that might be a barrier to implementation if you have providers who are uncomfortable taking on that responsibility, especially for something as serious as a potential cancer diagnosis. Yeah. In its initial overhead costs, someone has to interpret it and communicate the findings with the patient.
So that's a little bit of the point of our study. Were there the cost savings of, the potential cost savings of having the Cologuard test and all that is built in with that test, is that enough to overcome the major cost implications of the savings of a FIT test throughout our network? Mm hmm. Any time I read a study about health care economics, I always want to find out the distinction between cost versus charge. It seems like the two are almost completely unlinked. Right.
In your particular study, did you look at the acquisition costs, like what we actually paid out to do this study? Or were you looking at charges like, what did we charge the third party payer? Reimbursements. Yeah, we this, this claims data. So there are charges, but this is all the reimbursement rate. This is all the reimbursement rates were utilized. We used Medicare, Medicaid reimbursement rates for these noninvasive tests.
So what was paid out by the payer, because this is the costs, but the cost from the perspective of the payer of that being Highmark Health. Mm hmm. Okay. Got it. And when you calculated the yearly cost of colorectal cancer, you looked at cancer treatment in the first year following diagnosis and sort of multiply that out so it isn't in the first year, often the most expensive. Like aren't they getting the most cancer care and their surgical care, like in the first year after.
So wouldn't this kind of overestimate your estimated cost of colorectal cancer? Yes. No, that's a very important observation. Our study focused on the number of new incidences of colorectal cancer for a specific subset of patients, namely those who are screened within a designated calendar year. And this approach was purposeful. To understand the economic implications of a missed diagnosis within a similar number of patients for that particular year.
So essentially, we're providing a snapshot of the financial implications within the confines of that single year. So this is not to say that these costs are the sum total of the entire colorectal cancer burden. In fact, as you rightly pointed out, there are likely significant additional costs following the first year of treatment.
And given that many of these patients will have ongoing treatment, follow up visits, potentially face complications or recurrences, the financial impact will likely extend well beyond that one year window. However, for the purposes of this study, as the cost of cancer was not different between the groups because there was a similar stage distribution based on that time of diagnosis between the groups. The cost saving implications would not change with a transition to FIT alone.
So, you know, after reading your paper, I think you've convinced me. I have zero power in my institution and in my organization regarding the choice of noninvasive screening modality. But I don't mean to put you on the spot. But what did you, after you did this study came to the conclusions and brought it back to the organization. What are the next steps for you, for your group and your institution? So a lot of it is education. So there are obviously profound cost implications.
And this is directly in line with the task force, the United States task force that we mentioned for delivering cost effective screening, noninvasive screening modalities for patients. We use this as an as an education and to develop a campaign across our network to promote the use of this testing modality amongst the primary care physicians. That's what we're at this point in time. It's essentially educational.
And there are going to be additional incentives to the primary care practices based on certain reimbursement models for how they perform their screening tests. But at this point in time, it's purely educational. But there is a campaign and there is a shift within our network to push and incentivize the utilization of FIT over Cologuard throughout the network. Great. Well, thank you. What else have I missed?
What question haven't I asked or what what additional final thoughts do you have about this, this topic? So to be honest with you, I do. I'm not a primary care physician. I'm not even a dedicated colorectal cancer specialist. I'm a surgical oncologist. And while the specifics of this study are important, I think the very interesting aspect of this study is the analytic approach.
So as we in the United States are increasingly shifting towards a value based paradigm in health care, much of our care delivery is going to be influenced by insurance companies. I think what makes this study, especially intriguing is its collaborative nature. So clinician researchers teamed up with analysts and actuaries from the payer side, and this allowed us to harness their robust data analytic capabilities while subjecting the data to academic scrutiny.
We feel that introducing not only the findings of this study, but also the research and analytic approach, the research approach to the academic world. We provided a new resource, a new insight for others to learn and benefit from. So we will continue to collaborate, both payers and providers, especially at Allegheny Health Network and Highmark Health.
And we feel that the future of health care is going to be in these collaborations where different stakeholders, including patients, providers, payers, sort of collaborate to enhance our understanding and delivery of cancer care. We've been talking today with Dr. Casey Allen, MD from Allegheny Health Network. I encourage everyone to read this excellent paper which is available now in the September 2023 issue of the Journal of the American College of Surgeons.
Thank you for listening to The Operative Word. Please send us any feedback at postmaster@facs.org. ♪♪[music]♪♪ Thank you for listening to the Journal of the American College of Surgeons Operative Word podcast. If you've enjoyed today's episode, spread the word on social media by using the hashtag, #JACSOperativeWord. Subscribe to The Operative Word wherever podcasts are available or listen on the American College of Surgeons website at facs.org/podcast. ♪♪[music]♪♪