Rate of Timely Follow-up on Positive Stool-based Tests for Colorectal Cancer Detection

Nevada Cancer Coalition would like to provide a comment of support for the proposal to add a measure for timely follow-up colonoscopy to stool based tests to its Merit-based Incentive Payment System (MIPS) with a 180 day timeframe. Nevada Cancer Coalition is dedicated to prevention and early detection of cancer to improve survivorship and quality of life. The addition of this measure is a step in supporting systems for improved early detection, survivorship, and quality of life. We appreciate your consideration. 

December 23, 2025

Dear PRMR Clinician Committee:

Geneoscopy appreciates the opportunity to comment in support of CMS’s proposal to add a measure for timely follow-up colonoscopy after stool-based colorectal cancer screening tests to the Merit-based Incentive Payment System (MIPS), using a 180-day timeframe. As proposed, this measure would be included among the optional measures that Medicare Part B providers may elect to report.

Geneoscopy views this proposal as an important and encouraging acknowledgment of the critical role that follow-up colonoscopy plays in the colorectal cancer screening continuum. Even as a voluntary measure, MIPS reporting can help establish the data foundation needed to set appropriate benchmarks in the future and begin aligning incentives around completion of the full screening pathway.

Geneoscopy fully supports this proposed measure and strongly believes in incentive-based programs that ensure patients who require a follow-up colonoscopy receive the care they need. Measures that effectively track, assess, and incentivize appropriate follow-up are essential to improving outcomes, and this proposal represents a meaningful step toward strengthening accountability across the screening continuum.

As part of this discussion, Geneoscopy would like to highlight a key limitation in the current measurement framework that this proposal has the opportunity to help address. Today, the FDA-approved and guideline included multi-target stool RNA test (ColoSense) does not count toward the colorectal cancer screening measure, and when a ColoSense result is positive, it does not create a recognized open gap in care for follow-up colonoscopy. As a result, patients may be appropriately screened and identified as needing diagnostic follow-up, yet neither the screening nor the need for follow-up is fully captured in existing quality metrics.

With a national goal of achieving 80% colorectal cancer screening in every community, it is essential that quality measures capture the non-invasive screening modality prescribed by the patient’s provider and deemed the most appropriate option for that individual. If screening tests are not counted and positive results do not generate measurable gaps in care, it becomes difficult to accurately assess who has truly been screened and where follow-up is still needed. Measures that meaningfully capture both screening and appropriate follow-up are critical to closing these gaps and driving real-world improvement.

Our support for this proposed measure is grounded not only in principle, but in practice. Geneoscopy has made a deliberate investment in supporting patients beyond the initial screening test because we recognize that follow-up colonoscopy is often the most challenging step in the pathway. Through our ColoSense360 program, we actively help navigate patients with a positive ColoSense result to diagnostic colonoscopy, directly addressing the very follow-up challenges this measure seeks to improve. Programs like this underscore the value of measurement frameworks that reinforce timely follow-up and align incentives with patient-centered care.

We respectfully request that in addition to adding this measure for timely follow-up colonoscopy after stool-based colorectal cancer screening tests, that the ColoSense also be recognized as a qualifying stool-based colorectal cancer screening test within the screening measure framework and that follow-up colonoscopy after a positive result be appropriately captured. Doing so would better align quality measurement, provider incentives, and patient care with the shared goal of improving colorectal cancer screening and outcomes.

Geneoscopy appreciates CMS’s leadership in advancing quality measurement across the colorectal cancer screening continuum and welcomes the opportunity to serve as a resource as this measure evolves.

Sincerely,

Erica Barnell, MD, PhD

Co-Founder and Chief Medical Officer
Geneoscopy

On behalf of Fight Colorectal Cancer (Fight CRC), we appreciate the opportunity to submit comments in response to MUC2025-043, Rate of Timely Follow-up on Positive Stool-based Tests for Colorectal Cancer Detection.

Fight CRC is a national patient advocacy organization dedicated to preventing colorectal cancer, improving early detection, and ensuring that all people diagnosed with colorectal cancer (CRC) receive high quality care. Our community includes patients, survivors, caregivers, clinicians, and researchers who see firsthand the consequences when abnormal non-invasive screening results are not followed by timely colonoscopy.

Fight CRC’s Colorectal Cancer Care Initiative (CRCCI), including the 2024 Colorectal Cancer Care Report, identifies timely colonoscopy following a positive CRC screening test as a top patient priority, and one of the most important system level failures contributing to preventable CRC deaths. Patients repeatedly reported that long waits following a positive test resulted in high emotional distress, prolonged uncertainty, and in some cases progression to later stage disease.

We are strongly supportive of CMS prioritizing a measure on timely follow up after a positive stool-based test for colorectal cancer. At the same time, we urge CMS to refine this measure in two critical ways:

1. Expand the measure to include all covered non-invasive CRC screening tests, not only stool-based tests.
2. Shorten the baseline follow up interval from 180 days to 90 days, with optional reporting at longer intervals.

Expand the measure to include all covered non-invasive CRC screening tests, not only stool-based tests.

Medicare beneficiaries are fortunate to have access to many options when choosing between covered colorectal cancer screening tests, including stool-based and blood based non-invasive options. These non-invasive tests play a vital role in expanding access to CRC screening, particularly in communities with limited access to colonoscopies. A non-invasive test alone however is not enough to confirm a diagnosis. It is medically necessary for patients who receive an abnormal result on any non-invasive test to complete a follow-up colonoscopy for screening to be complete. This includes blood-based tests, and will likely apply to future generations of non-invasive tests not yet on the market. Expanding the measure to include all non-invasive screening options will ensure that this measure can keep up with the rapid innovation in the cancer screening space.

Limiting the measure to stool based tests creates several problems. It would require providers to ensure timely follow up for some non-invasive tests but not others, even though every positive screening test carries the same expectation that a follow-up colonoscopy is needed. It also risks creating perverse incentives to preferentially promote non-covered modalities from the measure perspective in order to avoid accountability for follow up. Fight CRC therefore urges refining the measure to include a positive result from any CMS covered non-invasive CRC screening test.

Shorten the baseline follow up interval from 180 days to 90 days, with optional reporting at longer intervals.

Fight CRC recommends refining the measure to specify colonoscopy completion within 90 days as the primary performance benchmark. In quality measurement, the specified timeframe often becomes the de facto threshold that systems design toward. If CMS sets the measure at 180 days, many organizations may reasonably interpret that to mean it is acceptable for a substantial proportion of patients to wait five or six months for a diagnostic colonoscopy after a positive test that could represent cancer. 

Furthermore, a 180-day window risks masking important variation in how quickly systems move most patients through the full continuum of cancer screening. Two organizations with very different patterns, for example, one completing 80 percent of colonoscopies within 60 days, another completing most at 5 to 6 months, could look identical if both simply cross the 180-day threshold. 

A 180-day delay does not align with the patient-centered standards or with the evidence-based recommendations made through the Colorectal Cancer Care Report[1]. Analyzing real world data, the Care Report demonstrated a sharp drop-off in completion of a follow-up colonoscopy after the 90-day mark indicating that that providers and systems should be striving towards getting patients follow-up colonoscopies in this window while urgency still drives action for patients. Stakeholders across disciplines, including clinicians, researchers, and patient advocates, emphasized that 90 days is the appropriate operational target for achieving both timely care and improved outcomes, while six months should be considered an upper bound. 

From a patient perspective, a six month wait after a positive cancer screening result is deeply distressing. For patients in the CRC community, protracted delays are often experienced as a breakdown of the health system rather than a neutral operational choice.

Professional societies also emphasize the importance of timely follow up. The American Gastroenterological Association recommends that at least 80 percent of patients with a positive non-invasive screening test should receive a colonoscopy date within 3 months, and that colonoscopy should be completed within 6 months in all appropriate cases.[2] For these reasons, we recommend refinement of the measure by specifying colonoscopy completion within 90 days as the primary performance benchmark. 

Conclusion

Fight CRC appreciates CMS leadership in elevating timely follow up after abnormal CRC screening as a national quality priority. Ensuring timely colonoscopy after a positive non-invasive test will save lives and improve the quality of care for Medicare beneficiaries. 

We strongly support implementation of a measure in this space. We respectfully urge strengthening of the measure by including all CMS covered noninvasive CRC screening tests, and by shortening the core follow up window to 90 days, with additional reporting at 180 and 365 days. These refinements better reflect the evidence, clinical consensus, and patient centered priorities documented in Fight CRC’s Colorectal Cancer Care Initiative. 

Thank you for considering our comments. We welcome continued engagement as this important measure is refined.

Sincerely,

Anjee Davis, MPPA

CEO

Fight Colorectal Cancer

[1] Fight CRC. 2024 CARE Report. https://fightcolorectalcancer.org/resources/care-report/

[2] American Gastroenterological Association, Clinical Practice Guidance on the Use of Noninvasive CRC Screening Options. https://gastro.org/clinical-guidance/approach-to-the-use-of-noninvasive…

To Whom It May Concern:

The Society of Gastroenterology Nurses and Associates (SGNA) appreciates the opportunity to provide feedback on CMS’s proposal to add a measure for timely follow-up colonoscopy after stool-based tests to the Merit-based Incentive Payment System (MIPS).

SGNA strongly supports the inclusion of this measure. Timely follow-up colonoscopy is a critical component of the colorectal cancer screening continuum. Failure to complete follow-up after a positive stool-based test significantly increases the risk of delayed diagnosis and poorer patient outcomes. By incorporating this measure into MIPS, CMS acknowledges the importance of closing this gap in care and advancing quality improvement efforts.

We believe this measure will:

• Promote accountability for comprehensive screening processes.
• Align with value-based care principles and improve patient safety.
• Facilitate data collection to establish realistic benchmarks for future mandatory reporting.

While we recognize potential challenges—such as interoperability and coordination across care settings—these are surmountable and should not delay implementation. This measure represents an essential step toward ensuring patients receive timely, appropriate care following initial screening.

SGNA will continue to advocate for measures that improve colorectal cancer screening and follow-up. We appreciate CMS’s leadership in prioritizing this issue and look forward to collaborating with stakeholders to support successful adoption

BCBSA supports this measure.

The California Colorectal Cancer Coalition (C4) Board of Directors strongly supports CMS’ effort to implement a novel measure to ensure timely follow up on positive non-invasive tests for colorectal cancer detection required to confirm or exclude the presence of colorectal cancer. To optimize the reach and effectiveness of the novel measures, we recommend modifications to the proposed quality measure, including modification of the title to be more inclusive of all currently approved non-invasive testing modalities, modify the inclusion and exclusion criteria for the denominator, modify the denominator exception details, and update the rationale to be inclusive of the newest blood-based tests, such as Shield.

January 5, 2026, 

Thank you for the opportunity to submit comments in response to MUC2025-043: Rate of Timely Follow-up on Positive Stool-based Tests for Colorectal Cancer Detection.

I am a gastroenterologist and Professor of Medicine at UC San Diego. My research and clinical practice includes a focus on optimizing colorectal cancer screening and prevention. As such, I strongly support CMS’ effort to implement a novel measure to ensure timely follow up on positive non-invasive tests for colorectal cancer detection required to confirm or exclude the presence of colorectal cancer. Improving accountability for colonoscopy completion will provide a critical incentive to improve timely access to care for patients.

To optimize the reach and effectiveness of the novel measures, I recommend the following modifications: 

1. Modify the title to: “Timely follow-up on non-invasive tests for colorectal cancer detection”. 

Rationale: The Food and Drug Administration (FDA) has recently approved both novel stool and blood-based noninvasive tests for CRC detection, and Medicare has issued a coverage decision that is in favor of coverage of one of the novel blood-based tests, Shield. To optimize impact, we recommend that the measure cover all non-invasive tests for CRC detection, and that throughout the measure description, reference is made to both stool and blood-based noninvasive tests for CRC detection.

2. Modify the denominator to reflect inclusion of FDA approved non-invasive tests as follows: Identify all stool-based colorectal cancer screening tests (i.e., high-sensitivity guaiac fecal occult blood test, fecal immunochemical test, ColoSense or Cologuard) and all blood-based colorectal cancer screening tests (Shield) with result dates in the measurement period (i.e., calendar year) [value set “Colorectal Screening” OID 2.16.840.1.113762.1.4.1206.57].

3. Modify the denominator exclusions to remove the exclusion of inpatient and emergency department tests. Rationale: some patients with positive non-invasive tests done in inpatient and emergency department tests may have increased risk for CRC. Further, inclusion of inpatient and emergency department tests will encourage test stewardship to limit use within inpatient and emergency settings. Reference: Arjun Gupta, Zhouwen Tang, Deepak Agrawal, Eliminating in-Hospital Fecal Occult Blood Testing: Our Experience with Disinvestment, The American Journal of Medicine (2018), https://doi.org/10.1016/j.amjmed.2018.03.002.

4. Modify the denominator exception details to exclude people with colonoscopy within 1 year prior, rather than 3 years prior to the abnormal non-invasive result. Rationale: An abnormal stool test result still confers increased risk for colorectal cancer in people with a prior colonoscopy. 

5. Modify the rationale section to note that the FDA has recently approved a blood-based test for screening, as well as to note recently published data on suboptimal rates of colonoscopy follow up after an abnormal blood-based CRC detection test. Rationale: FDA has approved a blood-based test (Shield) for colorectal cancer screening followed by colonoscopy for an abnormal result, and Medicare has granted Advanced Diagnostic Laboratory Test status for coverage of the test under the Medicare Clinical Laboratory Fee Schedule. A recent study of 6068 individuals who had a blood-based Shield test, reported that just 49% of the 228 individuals with a positive result completed colonoscopy within 6 months, and that individuals with Medicare Advantage insurance were less likely to complete colonoscopy compared with privately insured individuals (odds ratio 0.26, 95% CI 0.11–0.67; Zaki Gastroenterology 2025;169:1301–1303). 

Suggested Modifications

Title: Timely follow-up on non-invasive tests for colorectal cancer detection.

Denominator: Patients aged 45 to 75 years with at least one positive stool or blood-based colorectal cancer screening test result date during the measurement period (i.e., calendar year). Only the first positive stool or blood-based test result (i.e., index screening test) is included in the measure calculation. No changes

• Denominator Details:

1. Identify all stool-based colorectal cancer screening tests (i.e., high-sensitivity guaiac fecal occult blood test, fecal immunochemical test, or Cologuard) with result dates in the measurement period (i.e., calendar year) [http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1206.56].

1. Modify to include blood-based tests and other FDA approved tests: Identify all stool-based colorectal cancer screening tests (i.e., high-sensitivity guaiac fecal occult blood test, fecal immunochemical test, ColoSense or Cologuard) and all blood-based colorectal cancer screening tests (Shield) with result dates in the measurement period (i.e., calendar year) [value set “Colorectal Screening” OID 2.16.840.1.113762.1.4.1206.57].

• Retain stool or blood tests with positive results.

   

• Retain stool or blood tests where patients were aged between 45 and 75 years on the positive stool test result date [value set "Birth Date" OID 2.16.840.1.113883.3.560.100.4].

• The Patients with at least one positive stool or blood test result are included in the target population.

• Denominator exclusions

Rationale: Exclude positive stool or blood-based colorectal cancer screening tests that were not an index test within the calendar year. Exclude index positive stool or blood tests from the denominator population where patients had a history of colorectal cancer or total colectomy, or recently received hospice or palliative care.

• Denominator Exclusions Details:

• Identify the first positive stool- or blood-based colorectal cancer screening test result in the measurement period (i.e., calendar year) for each patient to define the index positive stool or blood tests and index test result dates [value set “Colorectal Screening” OID 2.16.840.1.113762.1.4.1206.57].

• [value sets: “Encounter Inpatient” OID 2.16.840.1.113883.3.666.5.307; “Emergency Department Evaluation and Management Visit” OID 2.16.840.1.113883.3.464.1003.101.12.1010].

• Exclude index positive stool or blood tests where the patient had a prior positive stool test result less than 1 year before the index positive stool or blood test result date.

• Exclude index positive stool or blood tests where patients had a documented history of colorectal cancer before the index positive stool test result date [value set: “Malignant Neoplasm of Colon” OID 2.16.840.1.113883.3.464.1003.108.12.1001].

• Exclude index positive stool or blood tests where patients had a documented history of total colectomy before the index positive stool test result date [value set: “Total Colectomy” OID 2.16.840.1.113883.3.464.1003.198.12.1019].

• Exclude index positive stool or blood tests where patients received hospice or palliative care within 1 year before or 180 days after the index positive stool test result date [value sets: “Hospice Care Ambulatory” OID 2.16.840.1.113883.3.526.3.1584; "Hospice Diagnosis" OID 2.16.840.1.113883.3.464.1003.1165; "Hospice Encounter" OID 2.16.840.1.113883.3.464.1003.1003; “Palliative Care Encounter” OID 2.16.840.1.113883.3.600.1.1575; "Palliative Care Diagnosis" OID 2.16.840.1.113883.3.464.1003.1167; "Palliative Care Intervention" OID 2.16.840.1.113883.3.464.1003.198.12.1135].

• Denominator exceptions

   

• Exclude index positive stool or blood tests from the denominator population only if the patients are not in the numerator population in cases where the patients completed a prior recent colonoscopy or died during the 180-day follow-up period.

• Denominator Exceptions Details:

• Exclude index positive stool or blood tests (only if patient not in the numerator population) where patients completed a colonoscopy within 1 year before the index positive stool or blood test result date [value set: “Colonoscopy” OID 2.16.840.1.113883.3.464.1003.108.12.1020].

• Exclude index positive stool or blood tests (only if patient not in the numerator population) where patients were deceased within 180 days after the index positive stool test result date [value set "Expired" OID 2.16.840.1.113762.1.4.1047.438].

Overall Rationale 

In 2023, colorectal cancer was the fourth leading cause of cancer mortality in the United States for men and women combined [1]. In 2025, around 107,320 patients will be diagnosed with colorectal cancer and 52,900 are expected to die from it. Early detection and removal of colorectal polyps and early-stage cancers prevents disease progression and improves the odds of survival [2]. Noninvasive screening tests (e.g., stool- and blood-based tests) are available to detect markers of abnormal growths. However, delays in follow-up colonoscopy reduce the benefits of screening by leading to missed opportunities for timely intervention.

Multiple guidelines recommend using stool-based tests (i.e., high-sensitivity gFOBT, FIT, FIT-DNA, FIT-RNA) as noninvasive screening options, and colonoscopy as the reference standard for follow-up in patients with a positive stool-based test result [3, 4, 5]. Further, FDA has approved a blood-based test (Shield) for colorectal cancer screening followed by colonoscopy for an abnormal result. An American Gastroenterological Association (AGA) Clinical Practice Update commentary recommended that at least 95% of patients receive a colonoscopy within 6 months of a positive noninvasive test result to complete the full screening process [6]. Existing literature supports this timeframe as patients who received their colonoscopies after the 6-month mark had a significantly higher risk of being diagnosed with more advanced stages of cancer [7]. 

Rates of timely follow-up in the U.S. are far below the benchmark recommended by the AGA. A 2023 study examining 39 U.S. health care organizations reported follow-up colonoscopy rates around 50% within 180 days of a positive stool-based test [8]. A follow-up study in 2024 reported rates of around 56.1% within the same timeframe [9]. A recent study of 6068 individuals who had a blood-based Shield test, reported that just 49% of the 228 individuals with a positive result completed colonoscopy within 6 months, and that individuals with Medicare Advantage insurance were less likely to complete colonoscopy compared with privately insured individuals (odds ratio 0.26, 95% CI 0.11–0.67; Zaki Gastroenterology 2025;169:1301–1303). 

Existing endorsed clinical quality measures report on the percentage of patients who received initial screening for colorectal cancer [10, 11]. This eCQM can be used to measure rates of timely completion of the full screening process after positive non-invasive colorectal cancer screening stool and blood-based test results to help improve health care delivery and quality in medical facilities and health systems across the U.S.

I greatly appreciate your efforts to add this important quality measure but hope these recommended modifications are taken into consideration as the measure is finalized.

Sincerely, 

Samir Gupta, MD, MSCS

Professor of Medicine

University of California San Diego

We recommend credit for documented outreach and navigation efforts and alignment with payer prior authorization timelines to avoid penalizing providers for delays outside their control. 

MUC2025-043: Rate of Timely Follow-up on Positive Stool-based Tests for Colorectal Cancer Detection (MIPS)

Merck supports the proposed “Timely Follow-up on Positive Stool-based Tests for Colorectal Cancer Detection” measure (MUC2025-043), recognizing its potential to enhance the quality of care in colorectal cancer. Colorectal cancer is the fourth leading cause of cancer mortality in the U.S. for men and women combined in 2023.^[1] Early detection and removal of colorectal polyps and early-stage cancers prevents disease progression and improves the odds of survival.^[2]

This measure, aligned with established clinical guidelines, emphasizes the importance of prompt diagnostic evaluation and can enable the initiation of effective therapies at a stage when they can have the greatest impact. Delays in ongoing evaluation and appropriate actions for patients with colorectal cancer may lead to later-stage diagnosis, resulting in limited treatment options and poorer outcomes.^[3],[4] Early detection and linkage to treatment are critical to improving survival rates and quality of life for patients.^[5] However, gaps in timely follow-up on positive stool-based tests are significant, with follow-up rates being reported near 50% in the literature.^[6] This quality measure can be used to measure rates of timely completion of the full screening process after positive non-invasive colorectal cancer screening stool-based test results to help improve the quality of health care delivery and patient outcomes. 

Overall, Merck encourages CMS to implement the “Timely Follow-up on Positive Stool-based Tests for Colorectal Cancer Detection” measure in the MIPS program. We are encouraged that CMS is continuing to prioritize care improvements for patients at risk of, or living with, cancer.

References

[1] U.S. Cancer Statistics Working Group. United States Cancer Cases and Death Statistics At a Glance. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention and National Cancer Institute. Published June 2025. Accessed December 16, 2025. https://gis.cdc.gov/Cancer/USCS/. 

[2] Corley DA, Jensen CD, Quinn VP, et al. Association between time to colonoscopy after a positive fecal test result and risk of colorectal cancer and cancer stage at diagnosis. JAMA. 2017 Apr 25;317(16):1631-41.

[3] Waddell O, Keenan J, Frizelle F. Challenges around diagnosis of early onset colorectal cancer, and the case for screening. ANZ J Surg. 2024 Oct;94(10):1687-92.

[4] Murchie P, Raja EA, Brewster DH, et al. Time from first presentation in primary care to treatment of symptomatic colorectal cancer: effect on disease stage and survival. Br J Cancer. 2014 Jul;111(3):461-9.

[5] Bresalier RS, Grady WM, Markowitz SD, et al. Biomarkers for early detection of colorectal cancer: the early detection research network, a framework for clinical translation. Cancer Epidemiol Biomarkers Prev. 2020 Dec 1;29(12):2431-40.

[6] Mohl JT, Ciemins EL, Miller-Wilson LA, et al. Rates of follow-up colonoscopy after a positive stool-based screening test result for colorectal cancer among health care organizations in the US, 2017-2020. JAMA Netw Open. 2023 Jan 3;6(1):e2251384.

January 5, 2026, 

Thank you for the opportunity to submit comments in response to MUC2025-043: Rate of Timely Follow-up on Positive Stool-based Tests for Colorectal Cancer Detection.

I am a gastroenterologist and Professor of Medicine at UC San Diego. My research and clinical practice includes a focus on optimizing colorectal cancer screening and prevention. This comment reflects my views and is not meant to represent the views of my employer. I strongly support CMS’ effort to implement a novel measure to ensure timely follow up on positive non-invasive tests for colorectal cancer detection required to confirm or exclude the presence of colorectal cancer. Improving accountability for colonoscopy completion will provide a critical incentive to improve timely access to care for patients.

To optimize the reach and effectiveness of the novel measures, I recommend the following modifications: 

1. Modify the title to: “Timely follow-up on non-invasive tests for colorectal cancer detection”. 

Rationale: The Food and Drug Administration (FDA) has recently approved both novel stool and blood-based noninvasive tests for CRC detection, and Medicare has issued a coverage decision that is in favor of coverage of one of the novel blood-based tests, Shield. To optimize impact, we recommend that the measure cover all non-invasive tests for CRC detection, and that throughout the measure description, reference is made to both stool and blood-based noninvasive tests for CRC detection.

2. Modify the denominator to reflect inclusion of FDA approved non-invasive tests as follows: Identify all stool-based colorectal cancer screening tests (i.e., high-sensitivity guaiac fecal occult blood test, fecal immunochemical test, ColoSense or Cologuard) and all blood-based colorectal cancer screening tests (Shield) with result dates in the measurement period (i.e., calendar year) [value set “Colorectal Screening” OID 2.16.840.1.113762.1.4.1206.57].

3. Modify the denominator exclusions to remove the exclusion of inpatient and emergency department tests. Rationale: some patients with positive non-invasive tests done in inpatient and emergency department tests may have increased risk for CRC. Further, inclusion of inpatient and emergency department tests will encourage test stewardship to limit use within inpatient and emergency settings. Reference: Arjun Gupta, Zhouwen Tang, Deepak Agrawal, Eliminating in-Hospital Fecal Occult Blood Testing: Our Experience with Disinvestment, The American Journal of Medicine (2018), https://doi.org/10.1016/j.amjmed.2018.03.002.

4. Modify the denominator exception details to exclude people with colonoscopy within 1 year prior, rather than 3 years prior to the abnormal non-invasive result. Rationale: An abnormal stool test result still confers increased risk for colorectal cancer in people with a prior colonoscopy. 

5. Modify the rationale section to note that the FDA has recently approved a blood-based test for screening, as well as to note recently published data on suboptimal rates of colonoscopy follow up after an abnormal blood-based CRC detection test. Rationale: FDA has approved a blood-based test (Shield) for colorectal cancer screening followed by colonoscopy for an abnormal result, and Medicare has granted Advanced Diagnostic Laboratory Test status for coverage of the test under the Medicare Clinical Laboratory Fee Schedule. A recent study of 6068 individuals who had a blood-based Shield test, reported that just 49% of the 228 individuals with a positive result completed colonoscopy within 6 months, and that individuals with Medicare Advantage insurance were less likely to complete colonoscopy compared with privately insured individuals (odds ratio 0.26, 95% CI 0.11–0.67; Zaki Gastroenterology 2025;169:1301–1303). 

Suggested Modifications

Title: Timely follow-up on non-invasive tests for colorectal cancer detection.

Denominator: Patients aged 45 to 75 years with at least one positive stool or blood-based colorectal cancer screening test result date during the measurement period (i.e., calendar year). Only the first positive stool or blood-based test result (i.e., index screening test) is included in the measure calculation. No changes

• Denominator Details:

1. Identify all stool-based colorectal cancer screening tests (i.e., high-sensitivity guaiac fecal occult blood test, fecal immunochemical test, or Cologuard) with result dates in the measurement period (i.e., calendar year) [http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1206.56].

1. Modify to include blood-based tests and other FDA approved tests: Identify all stool-based colorectal cancer screening tests (i.e., high-sensitivity guaiac fecal occult blood test, fecal immunochemical test, ColoSense or Cologuard) and all blood-based colorectal cancer screening tests (Shield) with result dates in the measurement period (i.e., calendar year) [value set “Colorectal Screening” OID 2.16.840.1.113762.1.4.1206.57].

• Retain stool or blood tests with positive results.

   

• Retain stool or blood tests where patients were aged between 45 and 75 years on the positive stool test result date [value set "Birth Date" OID 2.16.840.1.113883.3.560.100.4].

• The Patients with at least one positive stool or blood test result are included in the target population.

• Denominator exclusions

Rationale: Exclude positive stool or blood-based colorectal cancer screening tests that were not an index test within the calendar year. Exclude index positive stool or blood tests from the denominator population where patients had a history of colorectal cancer or total colectomy, or recently received hospice or palliative care.

• Denominator Exclusions Details:

• Identify the first positive stool- or blood-based colorectal cancer screening test result in the measurement period (i.e., calendar year) for each patient to define the index positive stool or blood tests and index test result dates [value set “Colorectal Screening” OID 2.16.840.1.113762.1.4.1206.57].

• [value sets: “Encounter Inpatient” OID 2.16.840.1.113883.3.666.5.307; “Emergency Department Evaluation and Management Visit” OID 2.16.840.1.113883.3.464.1003.101.12.1010].

• Exclude index positive stool or blood tests where the patient had a prior positive stool test result less than 1 year before the index positive stool or blood test result date.

• Exclude index positive stool or blood tests where patients had a documented history of colorectal cancer before the index positive stool test result date [value set: “Malignant Neoplasm of Colon” OID 2.16.840.1.113883.3.464.1003.108.12.1001].

• Exclude index positive stool or blood tests where patients had a documented history of total colectomy before the index positive stool test result date [value set: “Total Colectomy” OID 2.16.840.1.113883.3.464.1003.198.12.1019].

• Exclude index positive stool or blood tests where patients received hospice or palliative care within 1 year before or 180 days after the index positive stool test result date [value sets: “Hospice Care Ambulatory” OID 2.16.840.1.113883.3.526.3.1584; "Hospice Diagnosis" OID 2.16.840.1.113883.3.464.1003.1165; "Hospice Encounter" OID 2.16.840.1.113883.3.464.1003.1003; “Palliative Care Encounter” OID 2.16.840.1.113883.3.600.1.1575; "Palliative Care Diagnosis" OID 2.16.840.1.113883.3.464.1003.1167; "Palliative Care Intervention" OID 2.16.840.1.113883.3.464.1003.198.12.1135].

• Denominator exceptions

   

• Exclude index positive stool or blood tests from the denominator population only if the patients are not in the numerator population in cases where the patients completed a prior recent colonoscopy or died during the 180-day follow-up period.

• Denominator Exceptions Details:

• Exclude index positive stool or blood tests (only if patient not in the numerator population) where patients completed a colonoscopy within 1 year before the index positive stool or blood test result date [value set: “Colonoscopy” OID 2.16.840.1.113883.3.464.1003.108.12.1020].

• Exclude index positive stool or blood tests (only if patient not in the numerator population) where patients were deceased within 180 days after the index positive stool test result date [value set "Expired" OID 2.16.840.1.113762.1.4.1047.438].

Overall Rationale 

In 2023, colorectal cancer was the fourth leading cause of cancer mortality in the United States for men and women combined [1]. In 2025, around 107,320 patients will be diagnosed with colorectal cancer and 52,900 are expected to die from it. Early detection and removal of colorectal polyps and early-stage cancers prevents disease progression and improves the odds of survival [2]. Noninvasive screening tests (e.g., stool- and blood-based tests) are available to detect markers of abnormal growths. However, delays in follow-up colonoscopy reduce the benefits of screening by leading to missed opportunities for timely intervention.

Multiple guidelines recommend using stool-based tests (i.e., high-sensitivity gFOBT, FIT, FIT-DNA, FIT-RNA) as noninvasive screening options, and colonoscopy as the reference standard for follow-up in patients with a positive stool-based test result [3, 4, 5]. Further, FDA has approved a blood-based test (Shield) for colorectal cancer screening followed by colonoscopy for an abnormal result. An American Gastroenterological Association (AGA) Clinical Practice Update commentary recommended that at least 95% of patients receive a colonoscopy within 6 months of a positive noninvasive test result to complete the full screening process [6]. Existing literature supports this timeframe as patients who received their colonoscopies after the 6-month mark had a significantly higher risk of being diagnosed with more advanced stages of cancer [7]. 

Rates of timely follow-up in the U.S. are far below the benchmark recommended by the AGA. A 2023 study examining 39 U.S. health care organizations reported follow-up colonoscopy rates around 50% within 180 days of a positive stool-based test [8]. A follow-up study in 2024 reported rates of around 56.1% within the same timeframe [9]. A recent study of 6068 individuals who had a blood-based Shield test, reported that just 49% of the 228 individuals with a positive result completed colonoscopy within 6 months, and that individuals with Medicare Advantage insurance were less likely to complete colonoscopy compared with privately insured individuals (odds ratio 0.26, 95% CI 0.11–0.67; Zaki Gastroenterology 2025;169:1301–1303). 

Existing endorsed clinical quality measures report on the percentage of patients who received initial screening for colorectal cancer [10, 11]. This eCQM can be used to measure rates of timely completion of the full screening process after positive non-invasive colorectal cancer screening stool and blood-based test results to help improve health care delivery and quality in medical facilities and health systems across the U.S.

I greatly appreciate your efforts to add this important quality measure but hope these recommended modifications are taken into consideration as the measure is finalized.

Sincerely, 

Samir Gupta, MD, MSCS

Professor of Medicine

University of California San Diego

January 6, 2026

Dear PRMR Clinician Committee:

On behalf of American College of Gastroenterology (ACG) and American Society for Gastrointestinal Endoscopy (ASGE), we appreciate the opportunity to submit comments in response to MUC2025-043, Rate of Timely Follow-up on Positive Stool-based Tests for Colorectal Cancer Detection.

Our societies support the intent of this measure; positive noninvasive tests for colorectal cancer detection require timely follow up to confirm or exclude the presence of colorectal cancer. However, for measurement to be meaningful and actionable it must be conducted at the appropriate level. We have many concerns with considering this measure for inclusion in the Merit-based Incentive Payment System (MIPS). The preliminary assessment bases its evaluation on the measure’s endorsement; however, it was endorsed at the facility and integrated delivery system level using hospital outpatient and integrated delivery system data. On review of the additional testing provided at the individual clinician and group level, we do not believe that this measure should be considered appropriate for inclusion in MIPS for the following reasons:

• The submission does not address whether any of the gap in performance could be due to individuals receiving their follow-up colonoscopy with a different clinician or group. There are potential factors that are outside of the control of the clinician or group such as the possibility that patients receive their follow-up at another facility. Recognizing those who report all payer data via qualified clinical data registries, further complicating consistent evaluation of performance on this measure is patients receiving stool-based test kits directly from insurers without the knowledge of those clinicians who may be evaluated on the measure. These apparent measure failures are reflections of factors that are outside of the control of a given clinician or group and would unfairly impact performance results. A measure that does not account for all scenarios and does not reflect true performance should not be included in an accountability program. 

   

• This measure will likely not achieve acceptable reliability rates at the individual clinician and group levels. Currently, the measure steward does not recommend that this measure be used at the individual clinician level due to very low sample sizes and while some of the signal-to-noise ratio (SNR) results at the facility group level were acceptable (>0.7), the minimum SNRs were very low and two years of the data (2022 and 2023) had “substantially larger sample sizes accounting for 56% of the data used for the analysis.” It is not clear whether any of the individual clinicians and/or facility groups successfully met a minimum sample size of 20 patients, which is what MIPS requires to set a benchmark and it is very likely that denominator counts could vary significantly from year to year based on the rate of patients who choose to use a noninvasive screening test and subsequently test positive. We do not believe that this measure will be able to produce performance scores that could be considered reliable at the individual clinician and group levels as a result.

• This measure will miss a portion of the population at risk because it currently only includes positive stool-based tests but does not capture other noninvasive tests, such as blood-based colorectal cancer screening (CRC) tests or Computed Tomography Colonography.
  • The U.S. Food and Drug Administration recently approved two blood-based tests.(1) Further, the Centers for Medicare and Medicaid Services (CMS) covers a blood-based biomarker screening test for colorectal cancer once every 3 years(2) and expanded its approach to a “Complete CRC Screening” by adding that either a positive Medicare-covered blood-based biomarker test or noninvasive stool-based test is part of the CRC screening continuum and the follow-on colonoscopy would not incur beneficiary cost-sharing.(3) While the U.S. Preventive Services Task Force does not currently include blood-based tests among its recommendations for methods for Screening for Colorectal Cancer, patients with positive blood-based CRC screening tests should be included in the measure as they require a follow-up colonoscopy.
  • Effective January 1, 2025, CMS expanded coverage for CRC screening to include Computed Tomography Colonography (CTC).(4)

Our societies support providing patients with multiple CRC screening options and agree that improving accountability for colonoscopy completion is critical to providing patients with timely access to care. Given the concerns noted above, we do not support inclusion of this measure as specified in MIPS. 

Sincerely,

William D. Chey, MD, MACG

President 

American College of Gastroenterology

Amitabh Chak, MD, MASGE

ASGE President

American Society for Gastrointestinal Endoscopy

(1) https://www.cancer.org/cancer/types/colon-rectal-cancer/detection-diagn….

(2) https://www.medicare.gov/coverage/colorectal-cancer-blood-based-biomark…)%20once%20every%203%20years.

(3) https://www.federalregister.gov/d/2024-25382

(4) chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.cms.gov/files/document/r13248cp.pdf

Please see attached comments.

As a patient partner who 'failed' a stool based test years ago, and due to financial constraints did not go forward with the colonoscopy at that time, I now better understand the benefits of having an earlier colonoscopy than one years later. When I finally had my colonoscopy it was found I had a large mass and subsequently had a foot of my colon removed along with 15 nodes. The earlier someone is able have a colonoscopy rather than later can be beneficial as well as life saving. 6 months is a reasonable time frame for measurement as many people might have to save money to even have the colonoscopy or plan ahead to have time off work, there could be multiple reasons that that a colonoscopy is delayed by a few months as well as workforce shortages including available gastrologists. I believe this is a worthwhile measure. 

The American Medical Association (AMA) supports the intent of this measure; however, we have many concerns with considering this measure for inclusion in the Merit-based Incentive Payment System (MIPS). The preliminary assessment bases its evaluation on the measure’s endorsement; however, it was endorsed at the facility and integrated delivery system level using hospital outpatient and integrated delivery system data. On review of the additional testing provided at the individual clinician and group level, we do not believe that this measure should be considered appropriate for inclusion in MIPS for the following reasons:

• This measure will miss a portion of the population at risk because it currently includes positive stool-based tests but does not capture blood-based colorectal cancer screening (CRC) tests. The U.S. Food and Drug Administration recently approved two blood-based tests.[1] Further, the Centers for Medicare and Medicaid Services (CMS) covers a blood-based biomarker screening test for colorectal cancer once every 3 years[2] and expanded its approach to a “Complete CRC Screening” by adding that either a positive Medicare-covered blood-based biomarker test or non-invasive stool-based test is part of the CRC screening continuum and the follow-on colonoscopy would not incur beneficiary cost-sharing.[3] While the U.S. Preventive Services Task Force does not currently include blood-based tests among its recommendations for methods for Screening for Colorectal Cancer, patients with positive blood-based CRC screening tests should be included in the measure as they require a follow-up colonoscopy.
• The submission does not address whether any of the gap in performance could be due to individuals receiving their follow-up colonoscopy with a different clinician or group. There are the potential factors that are outside of the control of the clinician or group such as the possibility that patients receive their follow-up at another facility. These apparent measure failures are reflections of factors that are outside of the control of a given clinician or group, and this measure currently does not adequately address those scenarios.
• This measure will likely not achieve acceptable reliability rates at the individual clinician and group levels. Currently, the measure steward does not recommend that this measure be used at the individual clinician level due to very low sample sizes and while some of the signal-to-noise ratio results at the facility group level were acceptable (>0.7), the minimum SNRs were very low and two years of the data (2022 and 2023) had “substantially larger sample sizes accounting for 56% of the data used for the analysis.” It is not clear whether any of the individual clinicians and/or facility groups successfully met a minimum sample size of 20 patients, which is what MIPS requires to set a benchmark and it is very likely that denominator counts could vary significantly from year to year based on the rate of patients who choose to use a non-invasive screening test and subsequently test positive. We do not believe that this measure will be able to produce performance scores that could be considered reliable at the individual clinician and group levels as a result.   

Given these concerns, the AMA does not support inclusion of this measure in MIPS. 
 

[1] https://www.cancer.org/cancer/types/colon-rectal-cancer/detection-diagn…-

used.html#:~:text=The%202%20FDA%2Dapproved%2C%20blood,be%20different%20for%20each%20test.

[2] https://www.medicare.gov/coverage/colorectal-cancer-blood-based-biomark…-

tests#:~:text=Medicare%20covers%20a%20blood%2Dbased,available)%20once%20every%203%20years.

[3] https://www.federalregister.gov/d/2024-25382

The Colon Cancer Coalition appreciates the opportunity to submit comments in response to MUC2025-043, Rate of Timely Follow-up on Positive Stool-based Tests for Colorectal Cancer Detection. We support the proposal to add timely follow-up colonoscopy after a non-invasive colorectal cancer screening to the Merit-based Incentive Payment System (MIPS). 

The Colon Cancer Coalition works with communities across the United States to promote screening, provide education, and support those affected by colorectal cancer. Our primary goal is to reduce the incidence of this disease and eliminate death from colorectal cancer through widespread on-time screening through increased patient screening choice for all average risk adults 45 and older.

We know that colorectal cancer, when detected early, is highly treatable, boasting a 5-year survival rate of 91%. Access to noninvasive CRC screening options can increase screening rates and provide cancer detection before the disease has a chance to develop, but only if additional action is taken through colonoscopy following a positive result from an available non-invasive screening.

We are strongly supportive of this measure to promote timely follow up after a positive stool-based test for colorectal cancer. And at the same time, we echo our patient advocacy peers and urge CMS to refine this measure in two ways:

• Expanding the measure to include all non-invasive CRC screening tests, including blood-based screening and novel stool-based screening options.
• Shortening the follow up interval from 180 days to 90 days (with optional reporting at longer intervals).

We know non-invasive colorectal cancer screening options, including all covered stool-based and blood-based screening, are important to expanding access to CRC screening for all Americans, particularly areas where access to colonoscopies may be limited. Including all non-invasive screening options (not just existing stool-based methods) will help ensure this measure keeps up with the innovation happening in colorectal cancer screening and provides the most opportunities for patients to select the appropriate screening method for their situation.

Additionally, a 90 day follow-up interval is considered an appropriate target by many clinicians, researchers, and patient advocates for achieving both timely care and improved outcomes for colorectal cancer patients. Six months (180 days) should be considered the upper threshold. 

Follow-up colonoscopies after a non-invasive CRC screening play a critical role in finding cancer in the earliest stages when it is easiest to treat, saving lives and treatment costs in the process. Therefore, we respectfully request that CMS adds timely follow-up colonoscopy after all non-invasive colorectal cancer screening tests to MIPS.

Sincerely, 

Chris Evans

President

Colon Cancer Coalition 

Advocate Health appreciates the opportunity to provide feedback on MUC 2025-043, Rate of Timely Follow Up of Abnormal Positive Stool-Based Tests for Colorectal Cancer Detection. We ask for clarification regarding the lookback period. The measure should specify whether the lookback period is any time in the patient’s history, or during the measurement period. 

Dear PQM Development Staff: 

The American Cancer Society Cancer Action Network (ACS CAN) appreciates the opportunity to comment on the new quality measure related to the rate of timely follow-up on positive stool-based tests for colorectal cancer detection. ACS CAN is making cancer a top priority for public officials and candidates at the federal, state, and local levels. ACS CAN empowers advocates across the country to make their voices heard and influence evidence-based public policy change, as well as legislative and regulatory solutions that will reduce the cancer burden. As the American Cancer Society’s (ACS) nonprofit, nonpartisan advocacy affiliate, ACS CAN is more determined than ever to end cancer as we know it, for everyone.

ACS CAN strongly supports the proposal from the Centers for Medicare and Medicaid Services to add a measure for timely follow-up colonoscopy to stool-based tests to its Merit-based Incentive Payment System (MIPS). This proposal is also consistent with the position of ACS, which has asserted for many years, and stated in its screening guidelines,[1] that cancer screening should be understood as a continuum of testing rather than a single recommended screening test and should include all follow-up tests judged to be integral and necessary to resolve the question of whether an adult undergoing screening has cancer.[2] In a recent study conducted in a large health system, failure to follow-up a positive screening test accounted for 8% of all colorectal cancer deaths.

ACS has estimated that in 2025, 107,3020 cases of colon cancer would be diagnosed in the United States and an estimated 52,900 people would die from the disease.[3] Colorectal cancer remains one of the deadliest forms of cancer.[4] Colorectal cancer is the third most commonly diagnosed cancer and the third most common cause of cancer-related death in both men and women in the United States.[5] Furthermore, Alaska Natives have the highest colorectal cancer incidence rates in the world, nearly twice as high as American Indian individuals, who rank second in the U.S.[6]

Regular screening is the most effective way of detecting precancerous growths and early colorectal cancer. Removal of precancerous lesions can prevent colorectal cancer and cancers found at an early stage can be treated more easily, and lead to greater survival.[7] For colorectal cancer, the five-year survival rate is approximately 90 percent for patients aged 65 and older whose cancer is discovered and treated early.[8] In contrast, individuals aged 65 and older whose colorectal cancer is found at a later stage, after the cancer has metastasized, have a 10 percent five-year survival rate.[9] 

Conclusion

Thank you for the opportunity to comment on the proposed measure on the rate of timely follow-up on positive stool-based tests for colorectal cancer detection. If you have any questions, please feel free to contact me or have your staff contact Anna Schwamlein Howard, Policy Principal, Access and Quality of Care at [email protected].

Sincerely,

Marissa Brown

Senior Vice President, State and Local Advocacy

American Cancer Society Cancer Action Network

[1] Fontham ETH, Wolf AMD, Church TR, Etzioni R, et al. Cervical Cancer Screening for Individuals at Average Risk: 2020 Guideline Update From the American Cancer Society. CA Cancer J Clin. 2020; 321-346. doi:10.3322/caac.21628.

[2] American Cancer Society. American Cancer Society position statement on the elimination of patient cost-sharing associated with cancer screening and follow-up testing. Feb 26, 2023. Available from https://www.cancer.org/health-care-professionals/american-cancer-society-prevention-early-detection-guidelines/overview/acs-position-on-cost-sharing-for-screening-and-follow-up.html.

[3] American Cancer Society. Cancer Facts & Figures 2025. Atlanta: American Cancer Society; 2025.

[4] Siegal RL, Miller KD, Fuchs HE Jemal A. Cancer statistics, 2021. Cancer. 2021; 71:7-33, doi 10.3322/caac.21654.

[5] American Cancer Society. Colorectal Cancer Facts & Figures 2023-2025. Atlanta: American Cancer Society; 2024.

[6] Siegel, R. L., Wagle, N. S., Cercek, A., Smith, R. A., & Jemal, A. (2023). Colorectal cancer statistics, 2023. CA: A Cancer Journal for Clinicians, 73(3), 233-254. https://doi.org/10.3322/caac.21772.

[7] American Cancer Society. Cancer Prevention & Early Detection Facts & Figures 2023-2024. Atlanta: American Cancer Society; 2024. 

[8] Colorectal Cancer Facts & Figures 2023-2025. 

[9] Id.

January 6, 2026

Dear PRMR Clinician Committee:

On behalf of American College of Gastroenterology (ACG) and American Society for Gastrointestinal Endoscopy (ASGE), we appreciate the opportunity to submit comments in response to MUC2025-043, Rate of Timely Follow-up on Positive Stool-based Tests for Colorectal Cancer Detection.

Our societies support the intent of this measure; positive noninvasive tests for colorectal cancer detection require timely follow up to confirm or exclude the presence of colorectal cancer. However, for measurement to be meaningful and actionable it must be conducted at the appropriate level. We have many concerns with considering this measure for inclusion in the Merit-based Incentive Payment System (MIPS). The preliminary assessment bases its evaluation on the measure’s endorsement; however, it was endorsed at the facility and integrated delivery system level using hospital outpatient and integrated delivery system data. On review of the additional testing provided at the individual clinician and group level, we do not believe that this measure should be considered appropriate for inclusion in MIPS for the following reasons:

• The submission does not address whether any of the gap in performance could be due to individuals receiving their follow-up colonoscopy with a different clinician or group. There are potential factors that are outside of the control of the clinician or group such as the possibility that patients receive their follow-up at another facility. Recognizing those who report all payer data via qualified clinical data registries, further complicating consistent evaluation of performance on this measure is patients receiving stool-based test kits directly from insurers without the knowledge of those clinicians who may be evaluated on the measure. These apparent measure failures are reflections of factors that are outside of the control of a given clinician or group and would unfairly impact performance results. A measure that does not account for all scenarios and does not reflect true performance should not be included in an accountability program. 

   

• This measure will likely not achieve acceptable reliability rates at the individual clinician and group levels. Currently, the measure steward does not recommend that this measure be used at the individual clinician level due to very low sample sizes and while some of the signal-to-noise ratio (SNR) results at the facility group level were acceptable (>0.7), the minimum SNRs were very low and two years of the data (2022 and 2023) had “substantially larger sample sizes accounting for 56% of the data used for the analysis.” It is not clear whether any of the individual clinicians and/or facility groups successfully met a minimum sample size of 20 patients, which is what MIPS requires to set a benchmark and it is very likely that denominator counts could vary significantly from year to year based on the rate of patients who choose to use a noninvasive screening test and subsequently test positive. We do not believe that this measure will be able to produce performance scores that could be considered reliable at the individual clinician and group levels as a result.

• This measure will miss a portion of the population at risk because it currently only includes positive stool-based tests but does not capture other noninvasive tests, such as blood-based colorectal cancer screening (CRC) tests or Computed Tomography Colonography.
  • The U.S. Food and Drug Administration recently approved two blood-based tests.(1) Further, the Centers for Medicare and Medicaid Services (CMS) covers a blood-based biomarker screening test for colorectal cancer once every 3 years(2) and expanded its approach to a “Complete CRC Screening” by adding that either a positive Medicare-covered blood-based biomarker test or noninvasive stool-based test is part of the CRC screening continuum and the follow-on colonoscopy would not incur beneficiary cost-sharing.(3) While the U.S. Preventive Services Task Force does not currently include blood-based tests among its recommendations for methods for Screening for Colorectal Cancer, patients with positive blood-based CRC screening tests should be included in the measure as they require a follow-up colonoscopy.
  • Effective January 1, 2025, CMS expanded coverage for CRC screening to include Computed Tomography Colonography (CTC).(4)

Our societies support providing patients with multiple CRC screening options and agree that improving accountability for colonoscopy completion is critical to providing patients with timely access to care. Given the concerns noted above, we do not support inclusion of this measure as specified in MIPS. 

Sincerely,

William D. Chey, MD, MACG

President 

American College of Gastroenterology

Amitabh Chak, MD, MASGE

ASGE President

American Society for Gastrointestinal Endoscopy

(1) https://www.cancer.org/cancer/types/colon-rectal-cancer/detection-diagn….

(2) https://www.medicare.gov/coverage/colorectal-cancer-blood-based-biomark…)%20once%20every%203%20years.

(3) https://www.federalregister.gov/d/2024-25382

(4) chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.cms.gov/files/document/r13248cp.pdf

ECRI, a global nonprofit advancing evidence-based healthcare, has submitted the attached comments on the MUC with an emphasis on measures most relevant to patient safety and diagnostic excellence. 

ECRI supports the CMS Measures Under Consideration (MUC) List and its role in advancing meaningful, high-value measurement. Of particular significance are the measures focused on chronic disease management and diagnostic safety. Strengthening measurements in these domains supports more efficient, timely, and coordinated care across the healthcare system to better serve patients. 

The attached comments from ECRI include recommendations on the importance of patient-reported outcomes, minimizing unnecessary reporting burdens, and feedback in support of the following measures: 

• Timely Follow-up on Abnormal Screening Mammograms for Breast Cancer Detection (MUC2025-042)
• Timely Follow-up on Positive Stool-based Tests for Colorectal Cancer Detection (MUC2025-043)
• Adult Community-Onset (CO) Sepsis Standardized Mortality Ratio (MUC2025-045)
• Hospital Sepsis Program Core Elements Score (MUC2025-047)
• Hospital 30-Day, All-Cause, Risk-Standardized Readmission Rate Following Sepsis Hospitalization (MUC2025-055)
• Hospital Harm - Postoperative Venous Thromboembolism (MUC2025-067)

The AAFP recognizes the importance of timely follow-up on positive stool-based tests for colorectal cancer detection as a critical component of high-quality care. The measure has meaningful intent and potential to improve patient outcomes. However, its implementation in Medicare payment programs, particularly the CMS MIPS program, requires careful consideration of feasibility, equity, and clinical realities. We strongly encourage CMS to consider the challenges outlined below and work to resolve these issues.

Meaningfulness

• Assessment: The measure is meaningful and tailored to the needs of the target population. There is evidence that timely follow-up after a positive stool-based test is associated with improved patient outcomes and reduced costs. The measure highlights the importance of closing the loop on abnormal colorectal cancer (CRC) screening results, which is a critical gap in current practice.
• Implementation Considerations: Adoption may require updates to outpatient EMRs to distinguish between initial stool-based screening, subsequent colonoscopy, and screening colonoscopy. Obstacles such as scheduling and navigation challenges are important considerations. 

2. Appropriateness of Scale

• Assessment:  The measure is appropriate for the goals of some Medicare payment programs. However, as the measure developer noted in their submission: “based on these data and supported by stakeholder consultations, this eCQM is not recommended for use at the individual clinician level.”

3. Time to Value Realization

• Assessment: The proposed 6-month deadline for follow-up is reasonable and aligns with clinical guidelines. The measure is expected to yield both short- and long-term positive impacts on quality of care as it matures. It supports the collection of evidence for future improvements in CRC screening and follow-up. 

4. Additional Considerations

• Cost Implications: There is concern about the potential cost impact for patients. If the follow-up colonoscopy after a positive stool-based test is classified as "diagnostic," patients may face higher out-of-pocket costs. The measure should clarify and standardize language regarding the classification and cost implications of follow-up colonoscopies to ensure transparency and avoid unintended financial consequences.
  • If this measure is implemented and there comes a time when insurance companies are no longer required to cover USPSTF recommendations or a related recommendation is blocked by HHS, then this measure should be retired immediately from all payment programs. It would not be appropriate to hold clinicians accountable for services that insurance companies will not cover.
• Workforce Capacity: Expansion of gastroenterology fellowships and/or increasing the pool of qualified specialists may be necessary to ensure timely access to follow-up colonoscopies, especially as demand increases with broader adoption of stool-based screening.
• Market-based Forces: Because of the pressures of the Medicare Advantage Star Rating program, health plans are increasingly ordering these tests for their beneficiaries. Some of these patients are likely attributed to a PCP. Others do not have a PCP or may have been auto-attributed to a PCP but have never established care with them. Positive results may or may not be communicated to the attributed physician in a consistent and reliable way.  Some physicians or facilities may never receive these results but may still be held accountable to the performance measure even though the test was ordered by the health insurance company and completed outside of their care. In these increasingly common situations, the health plans need to be held accountable for ensuring the colonscopy is completed, or they should not be able to order the tests. The engagement of health insurance companies in the delivery of health care screenings and services fragments care and makes it difficult for clinicians to perform well on this measure.

Recommendation

Based on the above analysis, the AAFP has concerns about the inclusion of the "Rate of Timely Follow-up on Positive Stool-based Tests for Colorectal Cancer Detection" quality measure in the CMS MIPS program at this time. The following should be addressed first:

• Ensure EMR systems can accurately capture and report the required data elements.
• Address and clarify the cost implications for patients to prevent financial barriers.
• Monitor and support workforce capacity to meet increased demand for follow-up colonoscopies.
• Continue to evaluate the measure’s impact on health equity, especially in underserved populations. 

We appreciate the opportunity to provide the important family physician perspective on this and other measures under consideration. We encourage CMS to carefully consider our insight and suggestions outlined above.

Rationale: This measure reports the percentage of patients aged 45 to 75 years with at least one positive stool-based colorectal cancer screening test who completed a colonoscopy within 180 days after their positive stool-based test result date. Colorectal cancer is the second leading cause of cancer mortality in the United States for men and women combined. In 2025, around 107,320 patients will be diagnosed with colorectal cancer, and 53,010 are expected to die from it. We KNOW that early detection and removal of colorectal polyps and early-stage cancers prevent disease progression and improve the odds of survival. Yet, currently, there are no related measures that examine timely follow-up for positive stool-based colorectal screening tests; therefore, this measure fills a critical gap.