In this episode, Dr Dante Yeh is joined by Casey Allen, MD, from the Institute of Surgery, Division of Surgical Oncology, Allegheny Health Network, Pittsburgh, Pennsylvania. They discuss Dr Allen’s recent study, which found that widespread adoption of the fecal immunochemical test for noninvasive colorectal cancer screening could lead to substantial cost savings. This carries major value implications for a large population health system.
Disclosure Information: Dr Allen has nothing to disclose. Dr Yeh receives author royalties from UpToDate, advisory panel/training honoraria from Takeda Pharmaceuticals, and advisory panel honoraria from Baxter, Eli Lilly, and Fresenius Kabi.
To earn 0.25 AMA PRA Category 1 Credits™ for this episode of the JACS Operative Word Podcast, click here to register for the course and complete the evaluation. Listeners can earn CME credit for this podcast for up to 2 years after the original air date. Learn more about the Journal of the American College of Surgeons, a monthly peer-reviewed journal publishing original contributions on all aspects of surgery, including scientific articles, collective reviews, experimental investigations, and more.
#JACSOperativeWord
Mark as Played
Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
(00:00):
♪♪[music]♪♪
You are listening to ‘The Operative Word,’
a podcast brought to you by the Journalof the American College of Surgeons.
I'm Dr. Jamie Coleman.
And throughout this series,
Dr. Dante Yeh and I will speak with recentlypublished authors about the motivation
behind their latest researchand the clinical implications
(00:21):
it has for the practicing surgeon.
♪♪[music]♪♪
The opinions expressed in this podcastare those of the participants
and not necessarilythat of the American College of Surgeons.
♪♪[music]♪♪
Welcome to the Operative Word,
a podcast from the Journalof the American College of Surgeons.
I'm Dr. Dante Yeh.
(00:41):
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 NoninvasiveColorectal Cancer Screening Modalities.’
I'm honored to be joined todayby the first author,
Dr. Casey Allen, M.D.,
from the Allegheny Health Networkin Pittsburgh, Pennsylvania.
(01:02):
Dr. Allen, thank you for joining me today.
Before we begin, do you have any potentialconflicts 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 withcan you give us a brief summary
of your study designand describe to us your main findings?
So in light of the rising trend towardsnoninvasive colorectal cancer screening,
(01:24):
our research focused onunderstanding the long term cost
implications of two common modalities
the Fecal Immunochemical Testor FIT and Cologuard.
We analyzed over 119,000 patients
using a national insurerbased administrative data set
and integrated it inwith our own granular clinical data set.
(01:46):
We found over $13 million are spentannually
on these two noninvasive modalitieswithin our payor network alone.
However,by exclusively using FIT,
we found that health care systemscould potentially save millions of dollars
annually,reducing our own $13 million spend
to about half saving nearly $6 million
(02:07):
a year within our own system alone.
Moreover, early stagedetection rates were comparably high
for both tests, ensuring equal efficacyof these modalities.
But honestly, it'snot so much about those important findings
and the potential value implicationsto a large health system.
(02:28):
It's also about our novelanalytic approach.
In today's era of value based health care
decisions are heavilyinfluenced by insurance companies.
What sets our researchapart is the unique collaboration
between clinician researchersand experts from the payer sector.
And by combining their dataanalytic strengths
through our academic lens,we created a resource
(02:49):
that stands to benefitmany in the medical community.
These partnerships where payers,providers, patients,
other stakeholders collectively steerthe trajectory of care delivery,
can provide novel value based insightsAll right, great.
So I'm not going to tell you my age,but I'm staring down the barrel
of my first colonoscopy.
(03:10):
So I'm very, very interestedin 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 testand the Cologuard work?
So the fecal Immunochemical test
(03:31):
or the FIT testand Cologuard are both noninvasive
colorectal cancer screening modalities,but they function quite differently.
FIT worksby detecting occult blood in the stool.
It specifically targets human hemoglobinin the lower intestines of a colon.
The testis done by taking a small stool sample
and then using antibodies that aresensitive to the blood Proteins present.
(03:55):
The major advantage of FIT overother stool based tests is that it
does not react with red meat or vitaminC, so there are fewer
dietary restrictions and thus fewerfalse positives from the diet.
Cologuard, on the otherhand, is a multi target stool DNA test.
It combines both the detectionof occult blood, much like FIT
with the identification of certainDNA mutations such as KRAS
(04:18):
that are shed into the stoolfrom precancerous polyps or cancers.
When we talk about accuracy,both FIT and Cologuard
have a similar positiveand negative predictive value.
And so is it safe to sayalso that the accuracy
is similarbetween the FIT and the Cologuard?
(04:39):
Yes, essentiallythe 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 dothe FIT or the Cologuard?
Is it also once every ten years?
(05:02):
No, the FIT test is an annual test.
And the Cologuard is every three years.
So that
basically is what determinessome of the cost implications.
So you might be having a cheaper testwith the FIT
or Cologuard less intervals,but a higher price.
But it's not every ten yearslike the colonoscopy.
(05:24):
And how much stool do I have to collect
and do I have to store it in my fridgenext 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 brieflymentioned this in your study,
(05:46):
but I know it wasn'tthe focus of your study,
but how did these two noninvasivemodalities compare to other
noninvasive modalitiessuch as CT colonography?
Yeah.
So comparing these modalities
to other noninvasive modalities,
as you mentioned,there's the fecal occult blood test.
(06:08):
This test, the positive predictive value
and the negative predictivevalue of the fecal
occult blood testare quite similar to FIT, but
might be a little bit lowerin terms of sensitivity,
especially when considering adenomasor early stage cancers.
And additionally, the fecal occult bloodtests can be influenced
by diet and medications, which can lead tomore false positive results.
(06:32):
The CT colonography,
also known as the virtual colonoscopy,
uses CT scans to produceimages of the colon and rectum.
Its sensitivity is quite high, oftencomparable to traditional colonoscopy,
especially if its detectinga larger polyp or cancer
by the neg-
But the positive and negativepredictive value can vary
(06:56):
greatly, and one major limitation
is that if a polypor a suspicious lesion is detected,
then you’re basically requiredto undergo a traditional colonoscopy.
And that is basicallyan unnecessary test on that,
in that matter.
And you're supposed to undergoa traditional bowel preparation
before you do a CTcolonography, correct?
(07:19):
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 understandingnow of these other modalities
in your paper in the introduction,you state that the United States
(07:40):
Multi Society Task Force or
USMSTF, has issued guidelines on the use
and effectivenessof noninvasive screening modalities,
and that this task force actuallyrecommends FIT as the primary noninvasive
screening method because of its lowercost compared to Cologuard.
But how strong is the evidencesupporting these guidelines?
(08:03):
Is there high level evidenceor is this expert based opinion?
So the United StatesMulti Society Task Force or the USMSTF
is a collaborative effort among severalGI societies in United States.
Their guidelines are developed througha pretty rigorous process involving
systematic reviews of available evidence,consensus building among experts,
(08:25):
and they regularly update their guidelinesbased on new evidence.
So generally, the strength of evidenceis typically very high.
The task force did recognize
fecal occult blood test, as is recommended
as a modality for colorectal cancerscreening for several years.
(08:45):
But they recommend FIT,
as I mentioned,
because there's datasupporting from multiple large studies
that FIT over fecal occult blood test
is better due to its higher sensitivityfor cancer, fewer dietary restrictions
and better patient adherence.Similar to the CT colonography,
(09:09):
It is acknowledged by the task forceas an option for screening
and for certainpatients, it's appropriate.
However, they again, notethat there are potential downsides
include, including the fact
that any significant findingwould require a traditional colonoscopy.
Thus putting the patient at radiation,
unnecessary radiation exposurefrom the CT colonography,
(09:33):
and then also the possibilityof incidental findings
outsidethe colon that may require further testing
that is not cost effectiveor cost indicative.
You've already mentioned a couple of timesthat after a positive CT virtual
colonoscopy, you would need to follow upwith a traditional colonoscopy.
Is that also true for both FIT guardand Cologuard, if it comes back positive
(09:55):
and if both tests have high positivepredictive value, what would you do next?
Yeah, no, absolutely.
Any these are screening modalities.
I think that the thoughtis that with the CT colonography,
it's essentially a, it's a procedure of sorts.
It's a radiologic procedure requiresexposure and it's a high cost test.
(10:20):
So that in
addition as a screening modalityand the potential for acquiring yet
another procedurejust 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 breakdownof the different screening modalities
(10:41):
and the number of membersand also the percentages
it looks like far and awaythe most common modality
in this health systemwas 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%.
(11:03):
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 bitof all the noninvasive modalities.
This is I believethis is probably the most commonly
being done by primary carepractitioners doing screening.
(11:27):
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 providermight provide the risk and benefits
(11:48):
and potential advantages and disadvantages
to any of these modalities?
I think a lot of patients recognizethat 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
(12:08):
for the colonoscopy.
The FIT or Cologuard or fecal occult blood test,
a lot has to do with the capabilitiesof the clinic itself.
So for the FIT,
a lot of the test resultsneed to be interpreted by the physician
or the physician team.
However, Cologuard is more of an internalit's more industry
(12:29):
and it's analyzedmore by the by the company itself.
And that reduces a lot of the overhead
for the patientor excuse me, for the provider itself.
So a lot of the times it's just logistics.
It's basedon the capabilities of the clinic
and it dependson the preference of the patient.
All right. Got it.
(12:50):
Yeah.
Your study only includedpatients over the age of 50 years old.
Can we extrapolate these same
findings and conclusionsto younger patients or high risk patients
like those with ulcerative colitisor other genetic disorders?
That's a great question.
(13:11):
I think it's important to recognizethat our study specifically focused on
patients greater than 50 years because
this age group
has historically been the targetfor routine colorectal cancer screening.
However, the American Cancer
Society recentlyupdated its guidelines to recommend
routine screening for colorectal cancerstarting at age 45 instead of 50.
(13:34):
Because for those at average risk,because there's data
supporting an uptick in colorectal cancerrates among these younger adults.
Now, while
noninvasive modalities
like FIT and Cologuard can be usedin these younger populations,
it's important to individualize the screening approach.
Some younger individualsmay prefer noninvasive screening,
(13:57):
while others might optfor traditional gold standard colonoscopy,
especially if they have other risk factorsor symptoms.
And in terms of patientsthat are at high risk
for colorectal cancer, such
as those with inflammatory bowel diseaselike ulcerative colitis or other
genetic syndromeslike Lynch syndrome or FAP,
(14:20):
typically a more aggressiveand tailored screening approach is needed.
Routine colonoscopy at younger ageand more frequent intervals
is usually recommendeddue to this significantly elevated risk
of developing colorectal cancerin this population.
It's also important to note that inpatients with inflammatory bowel disease,
in addition to
detecting cancer,there's other important considerations,
(14:42):
such as assessing the extentand severity of their disease,
which isn't assessedwith these noninvasive testing modalities.
Thus, typically noninvasivescreening modalities might not offer
the comprehensivenessof what these high risk patients require.
Yeah, you make a good point about that.
I'd forgotten about that.
(15:02):
All right, great. Great.
Can you describe to methe hierarchical logic structure?
I'm not really familiar with the term,
and I was hoping to geta better explanation about it.
Yeah, honestly, I learned a lotfrom the High Mark analytic team.
They have several actuaries that
assess
(15:25):
how we
determinewhat patients treatments and testing
modalities are actually performedusing claims data
when we don't have the actual directevidence from the EHR.
So the hierarchical logicstructure used in our study
was a structured method to classifypatients based on their screening methods,
(15:45):
ensuring accuracy in
understanding the actual sequenceand reasoning behind their screenings.
So our first step was to distinguishbetween those who underwent a colonoscopy
as their primary evaluationand those and determined
those who had it as a follow upto noninvasive tests.
So we did this by identifying patientswho had a colonoscopy
(16:07):
before a colorectal cancer diagnosis.
In these patients, we reviewed theirhistory over the preceding six months
to check to see if they had undergoneany noninvasive screening modalities.
This included C.T.
colonography,fecal occult blood test, FIT, or Cologuard.
And if a claim for noninvasive testwas discovered in this six month
review priorto their diagnosis of colorectal cancer,
(16:30):
we classify them as those who underwentnoninvasive screening.
If we didn't find any claimfor a noninvasive test in those
that were diagnosedwith colorectal cancer,
we classified themas the colonoscopy group
because no invasive
test, no noninvasive test was performed.
And they and they had to undergoa diagnostic colonoscopy for their
(16:53):
to diagnose their cancer
for the rest of the population that wasnot diagnosed with colorectal cancer.
We basically classified theminto the screening group
based on their most recent screeningmethod 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 whatthat hierarchical logic structure was,
(17:14):
how we derived, what the primary screeningmodality for each patient was.
All right.
Yeah, it sounds pretty straightforwardnow that you explained it that way.
Yeah, I. I think it makes sense.
Um, you mentioned in your manuscriptthat the FIT
has two distinct Medicare codes.
(17:35):
Why are they associatedwith different costs?
Having two distinct Medicare codesis really just more reflective
of the nuances in how medical billing
and coding systems can often categorizeprocedures, test interventions.
So there's different FIT kits.
There's different FIT
kits or procedures that might have varyingmethodologies or materials used.
(17:58):
This can lead to differences in costsassociated 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 interpretationor the technology use to read
the results could differ as well.
(18:19):
So these distinctions can leadto variations in the cost structure.
So one code might encompass
a more comprehensive service,and another might encompass elements
such as patient consultation, datainterpretation, or even follow up care,
while others might simply coverthe cost of the test itself.
I see.
(18:39):
And you mentioned earlier
that the ordering providerhas to interpret the FIT results themselves.
Is that right? Yeah. Yeah.
And I can see how that might be a barrierto implementation
if you have providerswho are uncomfortable
taking on that responsibility,especially for something as serious
as a potential cancer diagnosis.
(19:00):
Yeah.
In its initial overhead costs,someone has to interpret
it and communicate the findingswith the patient.
So that's a little bitof the point of our study. Were there
the cost savings of, the potential costsavings
of having the Cologuard testand all that is built in with that test,
is that enough to overcomethe major cost implications
(19:22):
of the savings of a FIT testthroughout our network?
Mm hmm.
Any time I read a studyabout health care economics,
I always want to find out the distinction
between cost versus charge.
It seems like the twoare almost completely unlinked.
(19:42):
Right.
In your particular study,did you look at the acquisition costs,
like what we actually paid outto 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.
(20:04):
This is all
the reimbursement rates were utilized.
We used Medicare, Medicaid reimbursementrates for these noninvasive tests.
So what was paid out by the payer,because this is the costs,
but the cost from the perspectiveof the payer of that being Highmark Health.
Mm hmm. Okay. Got it.
And when you calculated the yearly cost
(20:24):
of colorectal cancer,you looked at cancer treatment
in the first year following diagnosisand sort of multiply that out
so it isn't in the first year, oftenthe most expensive.
Like aren't they getting the most cancer care
and their surgical care,like in the first year after.
(20:45):
So wouldn't this kind of overestimateyour estimated cost of colorectal cancer?
Yes. No, that's a very importantobservation.
Our study focused on the number of new
incidences of colorectal cancerfor a specific subset of patients,
namely those who are screenedwithin a designated calendar year.
(21:05):
And this approach was purposeful.
To understand the economic implicationsof a missed
diagnosis within a similar numberof patients for that particular year.
So essentially, we're providing a snapshot
of the financial implicationswithin the confines of that single year.
So this is not to say that
these costs are the sum totalof the entire colorectal cancer burden.
(21:28):
In fact, as you rightly pointed out,there are likely
significant additional costsfollowing the first year of treatment.
And given that many of these patientswill have ongoing treatment,
follow up visits, potentially facecomplications or recurrences,
the financial impact will likely extendwell beyond that one year window.
However, for the purposes of this study,
as the cost of cancer
(21:51):
was not different between the groups
because there was a similar stagedistribution
based on that time of diagnosisbetween the groups.
The cost saving implications would notchange 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 institutionand in my organization
(22:16):
regarding the choice of noninvasivescreening modality.
But I don't meanto 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 groupand your institution?
(22:39):
So a lot of it is education. So
there are obviously profound cost implications.
And this is directly in linewith the task force, the United States
task force that we mentionedfor delivering cost effective screening,
noninvasivescreening modalities for patients.
We use this as an as an education
and to develop a campaignacross our network to promote
(23:04):
the use of this testing modalityamongst the primary care physicians.
That's what we're at this point in time.
It's essentially educational.
And there are going to be additionalincentives to the primary care practices
based on certain reimbursement modelsfor how they perform
their screening tests.
(23:25):
But at this point in time,it's purely educational.
But there is a campaign andthere is a shift within our network to push
and incentivizethe utilization of FIT over Cologuard
throughout the network.
Great. Well, thank you.
What else have I missed?
What question haven't I asked or whatwhat additional
(23:46):
final thoughtsdo 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 cancerspecialist.
I'm a surgical oncologist.
And while the specificsof this study are important,
I think the very interestingaspect of this study
(24:08):
is the analytic approach.
So as we in the United States
are increasingly shifting towardsa value based paradigm in health care,
much of our care delivery is going to beinfluenced by insurance companies.
I think what makes this study,
especially intriguingis its collaborative nature.
(24:29):
So clinician researchers teamed upwith analysts and actuaries from the payer
side, and this allowed us to harness
their robust data analytic capabilities
while subjecting thedata to academic scrutiny.
We feel that
introducing not only the findingsof this study, but also the research
(24:49):
and analytic approach, the researchapproach to the academic world.
We provided a new resource, a new insightfor others to learn and benefit from.
So we will continue to collaborate,both payers and providers,
especially at Allegheny Health Networkand Highmark Health.
And we feel that the future of health careis going to be in these collaborations
(25:11):
where different stakeholders,including patients, providers, payers,
sort of collaborate to enhance ourunderstanding and delivery of cancer care.
We've been talking today with
Dr. Casey Allen, MD from Allegheny Health Network.
I encourage everyone to read thisexcellent paper which is available now
in the September 2023 issue of the Journalof the American College of Surgeons.
(25:34):
Thank you for listeningto The Operative Word.
Please send us any feedbackat postmaster@facs.org.
♪♪[music]♪♪
Thank you for listening to
the Journal of the American Collegeof Surgeons Operative Word podcast.
If you've enjoyed today's episode,spread the word on social media
by using the hashtag, #JACSOperativeWord.
(25:56):
Subscribe to The Operative Wordwherever podcasts are available
or listen on the American Collegeof Surgeons website at facs.org/podcast.
♪♪[music]♪♪
♪♪[music]♪♪
You are listening to ‘The Operative Word,’
a podcast brought to you by the Journalof the American College of Surgeons.
I'm Dr. Jamie Coleman.
And throughout this series,
Dr. Dante Yeh and I will speak with recentlypublished authors about the motivation
behind their latest researchand the clinical implications
(00:21):
it has for the practicing surgeon.
♪♪[music]♪♪
The opinions expressed in this podcastare those of the participants
and not necessarilythat of the American College of Surgeons.
♪♪[music]♪♪
Welcome to the Operative Word,
a podcast from the Journalof the American College of Surgeons.
I'm Dr. Dante Yeh.
(00:41):
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 NoninvasiveColorectal Cancer Screening Modalities.’
I'm honored to be joined todayby the first author,
Dr. Casey Allen, M.D.,
from the Allegheny Health Networkin Pittsburgh, Pennsylvania.
(01:02):
Dr. Allen, thank you for joining me today.
Before we begin, do you have any potentialconflicts 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 withcan you give us a brief summary
of your study designand describe to us your main findings?
So in light of the rising trend towardsnoninvasive colorectal cancer screening,
(01:24):
our research focused onunderstanding the long term cost
implications of two common modalities
the Fecal Immunochemical Testor FIT and Cologuard.
We analyzed over 119,000 patients
using a national insurerbased administrative data set
and integrated it inwith our own granular clinical data set.
(01:46):
We found over $13 million are spentannually
on these two noninvasive modalitieswithin our payor network alone.
However,by exclusively using FIT,
we found that health care systemscould potentially save millions of dollars
annually,reducing our own $13 million spend
to about half saving nearly $6 million
(02:07):
a year within our own system alone.
Moreover, early stagedetection rates were comparably high
for both tests, ensuring equal efficacyof these modalities.
But honestly, it'snot so much about those important findings
and the potential value implicationsto a large health system.
(02:28):
It's also about our novelanalytic approach.
In today's era of value based health care
decisions are heavilyinfluenced by insurance companies.
What sets our researchapart is the unique collaboration
between clinician researchersand experts from the payer sector.
And by combining their dataanalytic strengths
through our academic lens,we created a resource
(02:49):
that stands to benefitmany in the medical community.
These partnerships where payers,providers, patients,
other stakeholders collectively steerthe trajectory of care delivery,
can provide novel value based insightsAll right, great.
So I'm not going to tell you my age,but I'm staring down the barrel
of my first colonoscopy.
(03:10):
So I'm very, very interestedin 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 testand the Cologuard work?
So the fecal Immunochemical test
(03:31):
or the FIT testand Cologuard are both noninvasive
colorectal cancer screening modalities,but they function quite differently.
FIT worksby detecting occult blood in the stool.
It specifically targets human hemoglobinin the lower intestines of a colon.
The testis done by taking a small stool sample
and then using antibodies that aresensitive to the blood Proteins present.
(03:55):
The major advantage of FIT overother stool based tests is that it
does not react with red meat or vitaminC, so there are fewer
dietary restrictions and thus fewerfalse positives from the diet.
Cologuard, on the otherhand, is a multi target stool DNA test.
It combines both the detectionof occult blood, much like FIT
with the identification of certainDNA mutations such as KRAS
(04:18):
that are shed into the stoolfrom precancerous polyps or cancers.
When we talk about accuracy,both FIT and Cologuard
have a similar positiveand negative predictive value.
And so is it safe to sayalso that the accuracy
is similarbetween the FIT and the Cologuard?
(04:39):
Yes, essentiallythe 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 dothe FIT or the Cologuard?
Is it also once every ten years?
(05:02):
No, the FIT test is an annual test.
And the Cologuard is every three years.
So that
basically is what determinessome of the cost implications.
So you might be having a cheaper testwith the FIT
or Cologuard less intervals,but a higher price.
But it's not every ten yearslike the colonoscopy.
(05:24):
And how much stool do I have to collect
and do I have to store it in my fridgenext 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 brieflymentioned this in your study,
(05:46):
but I know it wasn'tthe focus of your study,
but how did these two noninvasivemodalities compare to other
noninvasive modalitiessuch as CT colonography?
Yeah.
So comparing these modalities
to other noninvasive modalities,
as you mentioned,there's the fecal occult blood test.
(06:08):
This test, the positive predictive value
and the negative predictivevalue of the fecal
occult blood testare quite similar to FIT, but
might be a little bit lowerin terms of sensitivity,
especially when considering adenomasor early stage cancers.
And additionally, the fecal occult bloodtests can be influenced
by diet and medications, which can lead tomore false positive results.
(06:32):
The CT colonography,
also known as the virtual colonoscopy,
uses CT scans to produceimages of the colon and rectum.
Its sensitivity is quite high, oftencomparable to traditional colonoscopy,
especially if its detectinga larger polyp or cancer
by the neg-
But the positive and negativepredictive value can vary
(06:56):
greatly, and one major limitation
is that if a polypor a suspicious lesion is detected,
then you’re basically requiredto undergo a traditional colonoscopy.
And that is basicallyan unnecessary test on that,
in that matter.
And you're supposed to undergoa traditional bowel preparation
before you do a CTcolonography, correct?
(07:19):
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 understandingnow of these other modalities
in your paper in the introduction,you state that the United States
(07:40):
Multi Society Task Force or
USMSTF, has issued guidelines on the use
and effectivenessof noninvasive screening modalities,
and that this task force actuallyrecommends FIT as the primary noninvasive
screening method because of its lowercost compared to Cologuard.
But how strong is the evidencesupporting these guidelines?
(08:03):
Is there high level evidenceor is this expert based opinion?
So the United StatesMulti Society Task Force or the USMSTF
is a collaborative effort among severalGI societies in United States.
Their guidelines are developed througha pretty rigorous process involving
systematic reviews of available evidence,consensus building among experts,
(08:25):
and they regularly update their guidelinesbased on new evidence.
So generally, the strength of evidenceis typically very high.
The task force did recognize
fecal occult blood test, as is recommended
as a modality for colorectal cancerscreening for several years.
(08:45):
But they recommend FIT,
as I mentioned,
because there's datasupporting from multiple large studies
that FIT over fecal occult blood test
is better due to its higher sensitivityfor cancer, fewer dietary restrictions
and better patient adherence.Similar to the CT colonography,
(09:09):
It is acknowledged by the task forceas an option for screening
and for certainpatients, it's appropriate.
However, they again, notethat there are potential downsides
include, including the fact
that any significant findingwould require a traditional colonoscopy.
Thus putting the patient at radiation,
unnecessary radiation exposurefrom the CT colonography,
(09:33):
and then also the possibilityof incidental findings
outsidethe colon that may require further testing
that is not cost effectiveor cost indicative.
You've already mentioned a couple of timesthat after a positive CT virtual
colonoscopy, you would need to follow upwith a traditional colonoscopy.
Is that also true for both FIT guardand Cologuard, if it comes back positive
(09:55):
and if both tests have high positivepredictive value, what would you do next?
Yeah, no, absolutely.
Any these are screening modalities.
I think that the thoughtis that with the CT colonography,
it's essentially a, it's a procedure of sorts.
It's a radiologic procedure requiresexposure and it's a high cost test.
(10:20):
So that in
addition as a screening modalityand the potential for acquiring yet
another procedurejust 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 breakdownof the different screening modalities
(10:41):
and the number of membersand also the percentages
it looks like far and awaythe most common modality
in this health systemwas 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%.
(11:03):
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 bitof all the noninvasive modalities.
This is I believethis is probably the most commonly
being done by primary carepractitioners doing screening.
(11:27):
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 providermight provide the risk and benefits
(11:48):
and potential advantages and disadvantages
to any of these modalities?
I think a lot of patients recognizethat 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
(12:08):
for the colonoscopy.
The FIT or Cologuard or fecal occult blood test,
a lot has to do with the capabilitiesof the clinic itself.
So for the FIT,
a lot of the test resultsneed to be interpreted by the physician
or the physician team.
However, Cologuard is more of an internalit's more industry
(12:29):
and it's analyzedmore by the by the company itself.
And that reduces a lot of the overhead
for the patientor excuse me, for the provider itself.
So a lot of the times it's just logistics.
It's basedon the capabilities of the clinic
and it dependson the preference of the patient.
All right. Got it.
(12:50):
Yeah.
Your study only includedpatients over the age of 50 years old.
Can we extrapolate these same
findings and conclusionsto younger patients or high risk patients
like those with ulcerative colitisor other genetic disorders?
That's a great question.
(13:11):
I think it's important to recognizethat our study specifically focused on
patients greater than 50 years because
this age group
has historically been the targetfor routine colorectal cancer screening.
However, the American Cancer
Society recentlyupdated its guidelines to recommend
routine screening for colorectal cancerstarting at age 45 instead of 50.
(13:34):
Because for those at average risk,because there's data
supporting an uptick in colorectal cancerrates among these younger adults.
Now, while
noninvasive modalities
like FIT and Cologuard can be usedin these younger populations,
it's important to individualize the screening approach.
Some younger individualsmay prefer noninvasive screening,
(13:57):
while others might optfor traditional gold standard colonoscopy,
especially if they have other risk factorsor symptoms.
And in terms of patientsthat are at high risk
for colorectal cancer, such
as those with inflammatory bowel diseaselike ulcerative colitis or other
genetic syndromeslike Lynch syndrome or FAP,
(14:20):
typically a more aggressiveand tailored screening approach is needed.
Routine colonoscopy at younger ageand more frequent intervals
is usually recommendeddue to this significantly elevated risk
of developing colorectal cancerin this population.
It's also important to note that inpatients with inflammatory bowel disease,
in addition to
detecting cancer,there's other important considerations,
(14:42):
such as assessing the extentand severity of their disease,
which isn't assessedwith these noninvasive testing modalities.
Thus, typically noninvasivescreening modalities might not offer
the comprehensivenessof what these high risk patients require.
Yeah, you make a good point about that.
I'd forgotten about that.
(15:02):
All right, great. Great.
Can you describe to methe hierarchical logic structure?
I'm not really familiar with the term,
and I was hoping to geta better explanation about it.
Yeah, honestly, I learned a lotfrom the High Mark analytic team.
They have several actuaries that
assess
(15:25):
how we
determinewhat patients treatments and testing
modalities are actually performedusing claims data
when we don't have the actual directevidence from the EHR.
So the hierarchical logicstructure used in our study
was a structured method to classifypatients based on their screening methods,
(15:45):
ensuring accuracy in
understanding the actual sequenceand reasoning behind their screenings.
So our first step was to distinguishbetween those who underwent a colonoscopy
as their primary evaluationand those and determined
those who had it as a follow upto noninvasive tests.
So we did this by identifying patientswho had a colonoscopy
(16:07):
before a colorectal cancer diagnosis.
In these patients, we reviewed theirhistory over the preceding six months
to check to see if they had undergoneany noninvasive screening modalities.
This included C.T.
colonography,fecal occult blood test, FIT, or Cologuard.
And if a claim for noninvasive testwas discovered in this six month
review priorto their diagnosis of colorectal cancer,
(16:30):
we classify them as those who underwentnoninvasive screening.
If we didn't find any claimfor a noninvasive test in those
that were diagnosedwith colorectal cancer,
we classified themas the colonoscopy group
because no invasive
test, no noninvasive test was performed.
And they and they had to undergoa diagnostic colonoscopy for their
(16:53):
to diagnose their cancer
for the rest of the population that wasnot diagnosed with colorectal cancer.
We basically classified theminto the screening group
based on their most recent screeningmethod 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 whatthat hierarchical logic structure was,
(17:14):
how we derived, what the primary screeningmodality for each patient was.
All right.
Yeah, it sounds pretty straightforwardnow that you explained it that way.
Yeah, I. I think it makes sense.
Um, you mentioned in your manuscriptthat the FIT
has two distinct Medicare codes.
(17:35):
Why are they associatedwith different costs?
Having two distinct Medicare codesis really just more reflective
of the nuances in how medical billing
and coding systems can often categorizeprocedures, test interventions.
So there's different FIT kits.
There's different FIT
kits or procedures that might have varyingmethodologies or materials used.
(17:58):
This can lead to differences in costsassociated 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 interpretationor the technology use to read
the results could differ as well.
(18:19):
So these distinctions can leadto variations in the cost structure.
So one code might encompass
a more comprehensive service,and another might encompass elements
such as patient consultation, datainterpretation, or even follow up care,
while others might simply coverthe cost of the test itself.
I see.
(18:39):
And you mentioned earlier
that the ordering providerhas to interpret the FIT results themselves.
Is that right? Yeah. Yeah.
And I can see how that might be a barrierto implementation
if you have providerswho are uncomfortable
taking on that responsibility,especially for something as serious
as a potential cancer diagnosis.
(19:00):
Yeah.
In its initial overhead costs,someone has to interpret
it and communicate the findingswith the patient.
So that's a little bitof the point of our study. Were there
the cost savings of, the potential costsavings
of having the Cologuard testand all that is built in with that test,
is that enough to overcomethe major cost implications
(19:22):
of the savings of a FIT testthroughout our network?
Mm hmm.
Any time I read a studyabout health care economics,
I always want to find out the distinction
between cost versus charge.
It seems like the twoare almost completely unlinked.
(19:42):
Right.
In your particular study,did you look at the acquisition costs,
like what we actually paid outto 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.
(20:04):
This is all
the reimbursement rates were utilized.
We used Medicare, Medicaid reimbursementrates for these noninvasive tests.
So what was paid out by the payer,because this is the costs,
but the cost from the perspectiveof the payer of that being Highmark Health.
Mm hmm. Okay. Got it.
And when you calculated the yearly cost
(20:24):
of colorectal cancer,you looked at cancer treatment
in the first year following diagnosisand sort of multiply that out
so it isn't in the first year, oftenthe most expensive.
Like aren't they getting the most cancer care
and their surgical care,like in the first year after.
(20:45):
So wouldn't this kind of overestimateyour estimated cost of colorectal cancer?
Yes. No, that's a very importantobservation.
Our study focused on the number of new
incidences of colorectal cancerfor a specific subset of patients,
namely those who are screenedwithin a designated calendar year.
(21:05):
And this approach was purposeful.
To understand the economic implicationsof a missed
diagnosis within a similar numberof patients for that particular year.
So essentially, we're providing a snapshot
of the financial implicationswithin the confines of that single year.
So this is not to say that
these costs are the sum totalof the entire colorectal cancer burden.
(21:28):
In fact, as you rightly pointed out,there are likely
significant additional costsfollowing the first year of treatment.
And given that many of these patientswill have ongoing treatment,
follow up visits, potentially facecomplications or recurrences,
the financial impact will likely extendwell beyond that one year window.
However, for the purposes of this study,
as the cost of cancer
(21:51):
was not different between the groups
because there was a similar stagedistribution
based on that time of diagnosisbetween the groups.
The cost saving implications would notchange 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 institutionand in my organization
(22:16):
regarding the choice of noninvasivescreening modality.
But I don't meanto 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 groupand your institution?
(22:39):
So a lot of it is education. So
there are obviously profound cost implications.
And this is directly in linewith the task force, the United States
task force that we mentionedfor delivering cost effective screening,
noninvasivescreening modalities for patients.
We use this as an as an education
and to develop a campaignacross our network to promote
(23:04):
the use of this testing modalityamongst the primary care physicians.
That's what we're at this point in time.
It's essentially educational.
And there are going to be additionalincentives to the primary care practices
based on certain reimbursement modelsfor how they perform
their screening tests.
(23:25):
But at this point in time,it's purely educational.
But there is a campaign andthere is a shift within our network to push
and incentivizethe utilization of FIT over Cologuard
throughout the network.
Great. Well, thank you.
What else have I missed?
What question haven't I asked or whatwhat additional
(23:46):
final thoughtsdo 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 cancerspecialist.
I'm a surgical oncologist.
And while the specificsof this study are important,
I think the very interestingaspect of this study
(24:08):
is the analytic approach.
So as we in the United States
are increasingly shifting towardsa value based paradigm in health care,
much of our care delivery is going to beinfluenced by insurance companies.
I think what makes this study,
especially intriguingis its collaborative nature.
(24:29):
So clinician researchers teamed upwith analysts and actuaries from the payer
side, and this allowed us to harness
their robust data analytic capabilities
while subjecting thedata to academic scrutiny.
We feel that
introducing not only the findingsof this study, but also the research
(24:49):
and analytic approach, the researchapproach to the academic world.
We provided a new resource, a new insightfor others to learn and benefit from.
So we will continue to collaborate,both payers and providers,
especially at Allegheny Health Networkand Highmark Health.
And we feel that the future of health careis going to be in these collaborations
(25:11):
where different stakeholders,including patients, providers, payers,
sort of collaborate to enhance ourunderstanding and delivery of cancer care.
We've been talking today with
Dr. Casey Allen, MD from Allegheny Health Network.
I encourage everyone to read thisexcellent paper which is available now
in the September 2023 issue of the Journalof the American College of Surgeons.
(25:34):
Thank you for listeningto The Operative Word.
Please send us any feedbackat postmaster@facs.org.
♪♪[music]♪♪
Thank you for listening to
the Journal of the American Collegeof Surgeons Operative Word podcast.
If you've enjoyed today's episode,spread the word on social media
by using the hashtag, #JACSOperativeWord.
(25:56):
Subscribe to The Operative Wordwherever podcasts are available
or listen on the American Collegeof Surgeons website at facs.org/podcast.
♪♪[music]♪♪
Popular Podcasts
Dateline NBC
Current and classic episodes, featuring compelling true-crime mysteries, powerful documentaries and in-depth investigations. Follow now to get the latest episodes of Dateline NBC completely free, or subscribe to Dateline Premium for ad-free listening and exclusive bonus content: DatelinePremium.com
24/7 News: The Latest
The latest news in 4 minutes updated every hour, every day.
Therapy Gecko
An unlicensed lizard psychologist travels the universe talking to strangers about absolutely nothing. TO CALL THE GECKO: follow me on https://www.twitch.tv/lyleforever to get a notification for when I am taking calls. I am usually live Mondays, Wednesdays, and Fridays but lately a lot of other times too. I am a gecko.