When the measure returns for maintenance (3 years), the measure developer should have:
- Conducted additional validity testing (data element in additional EHR); and
- Continued to monitor (e.g., qualitative assessments, empirical analyses) for unintended consequences (e.g., reduced access to colonoscopies) during implementation.
This electronic Clinical Quality Measure (eCQM) reports the percentage of patients aged 45 to 75 years with at least one positive stool-based colorectal cancer screening test (i.e., high-sensitivity guaiac fecal occult blood test, fecal immunochemical test, or Cologuard) during the measurement period (i.e., calendar year) who completed a colonoscopy within 180 days after their index (i.e., first) positive stool-based test result date.
Measure Specs
- General Information(active tab)
- Numerator
- Denominator
- Exclusions
- Measure Calculation
- Supplemental Attachment
- Measure Record
- Point of Contact
General Information
Colorectal cancer is the second leading cause of cancer mortality in the United States for men and women combined [1]. In 2024, around 152,810 patients will be diagnosed with colorectal cancer and 53,010 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-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) as noninvasive screening options, and colonoscopy as the gold standard for follow-up in patients with a positive stool-based test result [3, 4, 5]. The American Gastroenterological Association (AGA) recommends 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 established 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].
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-based test results to help improve health care delivery and quality in medical facilities and health systems across the U.S.
- Key Statistics for Colorectal Cancer. American Cancer Society. Accessed October 31, 2024. https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html.
- 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;317(16):1631-1641. doi:10.1001/jama.2017.3634. PMID: 28444278.
- Rex DK, Boland CR, Dominitz JA, et al. Colorectal Cancer Screening: Recommendations for Physicians and Patients from the U.S. Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol. 2017;112(7):1016-1030. doi:10.1038/ajg.2017.174. PMID: 28555630.
- Lopes G, Stern MC, Temin S, et al. Early Detection for Colorectal Cancer: ASCO Resource-Stratified Guideline [published correction appears in JCO Oncol Pract. 2022 Nov;18(11):775-778. doi: 10.1200/OP.22.00580]. J Glob Oncol. 2019;5:1-22. doi:10.1200/JGO.18.00213. PMID: 30802159.
- US Preventive Services Task Force, Davidson KW, Barry MJ, et al. Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement [published correction appears in JAMA. 2021 Aug 24;326(8):773. doi: 10.1001/jama.2021.12404]. JAMA. 2021;325(19):1965-1977. doi:10.1001/jama.2021.6238. PMID: 34003218.
- Burke CA, Lieberman D, Feuerstein JD. AGA Clinical Practice Update on Approach to the Use of Noninvasive Colorectal Cancer Screening Options: Commentary. Gastroenterology. 2022;162(3):952-956. doi:10.1053/j.gastro.2021.09.075. PMID: 35094786.
- Mutneja HR, Bhurwal A, Arora S, Vohra I, Attar BM. A delay in colonoscopy after positive fecal tests leads to higher incidence of colorectal cancer: A systematic review and meta-analysis. J Gastroenterol Hepatol. 2021;36(6):1479-1486. doi:10.1111/jgh.15381. PMID: 33351959.
- Mohl JT, Ciemins EL, Miller-Wilson LA, Gillen A, Luo R, Colangelo F. 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;6(1):e2251384. Published 2023 Jan 3. doi:10.1001/jamanetworkopen.2022.51384. PMID: 36652246.
- Ciemins EL, Mohl JT, Moreno CA, Colangelo F, Smith RA, Barton M. Development of a Follow-Up Measure to Ensure Complete Screening for Colorectal Cancer. JAMA Netw Open. 2024;7(3):e242693. Published 2024 Mar 4. doi:10.1001/jamanetworkopen.2024.2693. PMID: 38526494.
- #0034 Colorectal Cancer Screening (COL). NQF: Quality Positioning System. Updated March 26. 2023. Accessed May 24, 2024. https://www.qualityforum.org/Qps/QpsTool.aspx#qpsPageState=%7B%22TabType%22%3A1.
- Quality ID #113 (NQF 0034). Centers for Medicare & Medicaid Services. Accessed October 31, 2024. https://qpp.cms.gov/docs/QPP_quality_measure_specifications/CQM-Measures/2023_Measure_113_MIPSCQM.pdf.
Health System 1 data were used to calculate the eCQM rates, assess feasibility, and conduct reliability and validity testing. All analyses were conducted using data routinely collected and documented in the Epic EHR and reported for six years (2018 to 2023). Six facility groups were included in the analyses.
Health System 2 data were used to calculate eCQM rates and assess feasibility. All analyses were conducted using data routinely collected and documented in the Cerner (now Oracle Health) EHR and reported for eight years (2016 to 2023). One facility group was included in the analyses.
Health System 3 data were used to assess feasibility using the Allscripts EHR. eCQM rates are forthcoming.
Numerator
Patients in the denominator population who completed a colonoscopy within 180 days after their index (i.e., first) positive stool-based colorectal cancer screening test result date.
- If documented, extract the first colonoscopy occurring within 180 days after the index positive stool test result date for each patient [value set: “Colonoscopy” OID 2.16.840.1.113883.3.464.1003.108.12.1020].
- Patients that completed a colonoscopy within 180 days are included in the numerator population.
Denominator
Patients aged 45 to 75 years with at least one positive stool-based colorectal cancer screening test result date during the measurement period (i.e., calendar year). Only the first positive stool test result (i.e., index screening test) is included in the measure calculation.
- 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) [value set “Colorectal Screening” OID 2.16.840.1.113762.1.4.1206.57].
- Retain stool tests with positive results.
- Retain stool tests where patients were aged between 45 and 75 years on the positive stool test result date [value set "BirthDate" OID 2.16.840.1.113883.3.560.100.4].
- Patients with at least one positive stool test result are included in the target population.
Exclusions
Exclude positive stool-based colorectal cancer screening tests that were not an index test or were conducted in the inpatient or emergency department setting. Exclude index positive stool tests from the denominator population where patients had a history of colorectal cancer or total colectomy, or recently received hospice or palliative care. Exclude index positive stool 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.
- Identify the first positive stool-based colorectal cancer screening test result in the measurement period (i.e., calendar year) for each patient to define the index positive stool tests and index test result dates [value set “Colorectal Screening” OID 2.16.840.1.113762.1.4.1206.57].
- Exclude index positive stool tests conducted in inpatient or emergency department settings [value sets: “Inpatient Stay” OID 2.16.840.1.113762.1.4.1182.285; “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 tests where the patient had a prior positive stool test result less than 1 year before the index positive stool test result date.
- Exclude index positive stool 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 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 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; “Palliative Care Encounter” OID 2.16.840.1.113883.3.600.1.1575].
- Exclude index positive stool tests (only if patient not in the numerator population) where patients completed a colonoscopy within 3 years before the index positive stool test result date [value set: “Colonoscopy” OID 2.16.840.1.113883.3.464.1003.108.12.1020].
- Exclude index positive stool 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].
Measure Calculation
- 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) [value set “Colorectal Screening” OID 2.16.840.1.113762.1.4.1206.57].
- Retain stool tests with positive results.
- Retain stool tests where patients were aged between 45 and 75 years on the positive stool test result date [value set "BirthDate" OID 2.16.840.1.113883.3.560.100.4].
- Patients with at least one positive stool test result are included in the target population.
- Identify the first positive stool-based colorectal cancer screening test result in the measurement period (i.e., calendar year) for each patient to define the index positive stool tests and index test result dates.
- Exclude index positive stool tests conducted in inpatient or emergency department settings [value sets: “Inpatient Stay” OID 2.16.840.1.113762.1.4.1182.285; “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 tests where the patient had a prior positive stool test result less than 1 year before the index positive stool test result date.
- Exclude index positive stool 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 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 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; “Palliative Care Encounter” OID 2.16.840.1.113883.3.600.1.1575].
- If documented, extract the first colonoscopy occurring within 180 days after the index positive stool test result date for each patient [value set: “Colonoscopy” OID 2.16.840.1.113883.3.464.1003.108.12.1020].
- Patients that completed a colonoscopy within 180 days are included in the numerator population.
- Exclude index positive stool tests from the denominator population (only if patient not in the numerator population) where patients completed a colonoscopy within 3 years before the index positive stool test result date [value set: “Colonoscopy” OID 2.16.840.1.113883.3.464.1003.108.12.1020].
- Exclude index positive stool tests from the denominator population (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].
Once numerator and denominator populations are defined: - Calculate rate: Numerator population divided by denominator population and multiplied by 100 to calculate the percentage.
The measure is not stratified.
No minimum sample size specified.
Supplemental Attachment
Measure Record
Point of Contact
This electronic Clinical Quality Measure (eCQM) and related data specifications are owned and stewarded by the Brigham and Women's Hospital (BWH). BWH is not responsible for any use of the Measure. BWH makes no representations, warranties, or endorsement about the quality of any organization or physician that uses or reports performance measures and BWH has no liability to anyone who relies on such measures or specifications.
Ania Syrowatka
Boston, MA
United States
United States
Importance
Evidence
Colorectal cancer is the second most expensive cancer to treat after breast cancer, costing about $24.3 billion for both medical services and prescription drugs combined [1]. Colorectal cancer is easier to treat when caught in its earlier stages [2]. Around 89% of patients with early-stage colorectal cancer live for five years or more compared to only 16% with later-stage cancer [2]. Increasing screening rates to 80% can reduce colorectal cancer mortality by 33% by 2030 [3]. Increasing rates to 70% for adults aged 50-64 can reduce Medicare spending by over $10 billion by 2050 [4]. Therefore, screening via inexpensive noninvasive stool tests, like the high-sensitivity gFOBT, FIT, and FIT-DNA, are more cost-effective and cost-saving compared to no screening [5]. Screening strategies that use a combination of stool-based testing and follow-up colonoscopy lead to greater reductions in costs and gains in quality-adjusted life years (QALYs) than single-test strategies [5, 6, 7].
Patients with a positive stool test who do not receive follow-up colonoscopy within 180 days are at a significantly increased risk of being diagnosed with late-staged cancer [9]. In a 2017 study, facilities had follow-up rates as low as 28% within 365 days [10]. A 2023 retrospective analysis showed follow-up rates of 56% within a year of a positive stool-based test across 39 health care organizations [11]. Timely follow-up within 180 days was 51%, highlighting an urgent need for implementing interventions to reach the American Gastroenterological Association (AGA) 95% benchmark [11, 12].
Rates of timely follow-up were lower among historically disadvantaged and medically underserved communities, further emphasizing the necessity of tailored interventions to increase colonoscopy uptake for all patient populations. Black, Asian, and Hispanic/Latino patients, older individuals, non-English speakers, male patients, Medicare and Medicaid beneficiaries, those with no recent history of stool test use, and patients with one or more comorbidities were more likely to have a delayed follow-up [10, 11, 13, 14, 15, 16, 17].
Medical facilities and health systems face common challenges in increasing their rates of timely follow-up colonoscopy [10, 13, 14, 15, 16, 18, 19]. A 2022 study observed that site-level factors had a greater impact on follow-up colonoscopy rates than patient demographic factors [16]. Patients who did not have a referral for colonoscopy were more likely to miss opportunities for screening completion [10, 13, 14, 18]. Failure to provide adequate bowel preparation instruction to patients may further delay colonoscopy completion in patients with suboptimal bowel preparation [16, 20, 21]. Although some safety-net systems shared an electronic health record, inadequate documentation of patient data prevented tracking of follow-up [10, 18, 19]. Additionally, a lack of standard protocols for appropriate clinical workflows to coordinate care from the positive stool-based test to the colonoscopy have contributed to loss of follow-up [10, 13, 14, 15, 19].
Interventions for improving rates of timely colonoscopy uptake after positive stool-based tests have been outlined in the literature. Strategies like the timely transmission of referrals to GI specialists, patient navigation and case management, patient education on colorectal cancer screening and adequate bowel preparation, active patient outreach by the care coordination team, and electronic health record (EHR) reminders [19, 21, 22, 23, 24, 25]. EHR-based trigger algorithms have also been shown to be effective in reducing time to follow-up for colorectal cancer detection [18, 26]. These evidence-based approaches can be integrated into protocols to ensure the timeliness of care.
Timely follow-up rates were higher for patients with a positive FIT-DNA (i.e., multitarget stool DNA panel [mt-sDNA], Cologuard) than for positive FITs, suggesting that the FIT-DNA may increase adherence to the completion of screening [11].
In 2023, the United States Preventive Services Task Force (USPSTF) issued a call to action to increase the rates of follow-up colonoscopy after positive stool-based screening tests, stipulating that considerable out-of-pocket costs for follow-up colonoscopies may reduce rates of screening completion [27 ,28]. As of January 2023, commercial insurance and Medicare providers are federally obligated to cover the costs of follow-up colonoscopies to lower the impact of this financial disparity [17, 27, 28, 29].
Therefore, increases in the rates of timely follow-up colonoscopy will require the engagement of various stakeholders, including patients, health care providers, medical facilities, health systems, and regulatory bodies to dictate policies that can help prevent delayed follow-ups and improve colorectal cancer care outcomes for all patients. Furthermore, a 2023 study found that out of the clinicians representing over 30 health care sites in qualitative interviews, 100% were not aware of the low rates of follow-up colonoscopy within their organizations [11]. There are currently no standard tools and systems in place requiring medical facilities to track the rates of timely colonoscopy after a positive stool-based screening test.
This eCQM can be used to measure rates of timely follow-up colonoscopy within 180 days after positive stool-based testing for colorectal cancer detection. The development of this measure was informed by current clinical practice guidelines for colorectal cancer screening, recent published literature, and existing endorsed quality measures. The results of this measure can help facilities identify areas of improvement that may be specific to their particular setting and the communities being served. Facilities, health systems, and other stakeholders may also use this measure to develop targeted interventions to increase colonoscopy uptake in populations with lower rates of timely follow-up.
- National Cancer Institute. Financial burden of cancer care. Cancer Trends Progress Report. Reviewed March 2024. Accessed October 2024. https://progressreport.cancer.gov/after/economic_burden.
- Cancer Statistics Working Group. U.S. Cancer Statistics Data Visualizations Tool, based on 2021 submission data (1999–2021). U.S. Department of Health and Human Services, Centers for Disease Control and Prevention and National Cancer Institute. Updated June 2024. Accessed October 2024. www.cdc.gov/cancer/dataviz.
- U.S. Preventive Services Task Force; Davidson KW, Barry MJ, Mangione CM, et al. Screening for colorectal cancer: US Preventive Services Task Force recommendation statement. JAMA. 2021;325(19):1965–1977. doi:10.1001/jama.2021.6238. PMID: 34003218.
- Goede SL, Kuntz KM, van Ballegooijen M, et al. Cost-savings to Medicare from pre-Medicare colorectal cancer screening. Medical Care. 2015;53(7):630–638. PMID: 26067885.
- Ramos MC, Passone JAL, Lopes ACF, Safatle-Ribeiro AV, Ribeiro Júnior U, de Soárez PC. Economic evaluations of colorectal cancer screening: A systematic review and quality assessment. Clinics (Sao Paulo). 2023;78:100203. Published 2023 Apr 24. doi:10.1016/j.clinsp.2023.100203. PMID: 37099816.
- Dan YY, Chuah BY, Koh DC, Yeoh KG. Screening based on risk for colorectal cancer is the most cost-effective approach. Clin Gastroenterol Hepatol. 2012;10(3):266-71.e716. doi:10.1016/j.cgh.2011.11.011. PMID: 22100624.
- Dinh T, Ladabaum U, Alperin P, Caldwell C, Smith R, Levin TR. Health benefits and cost-effectiveness of a hybrid screening strategy for colorectal cancer. Clin Gastroenterol Hepatol. 2013;11(9):1158-1166. doi:10.1016/j.cgh.2013.03.013. PMID: 23542330.
- Burke CA, Lieberman D, Feuerstein JD. AGA Clinical Practice Update on Approach to the Use of Noninvasive Colorectal Cancer Screening Options: Commentary. Gastroenterology. 2022;162(3):952-956. doi:10.1053/j.gastro.2021.09.075. PMID: 35094786.
- Mutneja HR, Bhurwal A, Arora S, Vohra I, Attar BM. A delay in colonoscopy after positive fecal tests leads to higher incidence of colorectal cancer: A systematic review and meta-analysis. J Gastroenterol Hepatol. 2021;36(6):1479-1486. doi:10.1111/jgh.15381. PMID: 33351959.
- Issaka RB, Singh MH, Oshima SM, et al. Inadequate Utilization of Diagnostic Colonoscopy Following Abnormal FIT Results in an Integrated Safety-Net System. Am J Gastroenterol. 2017;112(2):375-382. doi:10.1038/ajg.2016.555. PMID: 28154400.
- Mohl JT, Ciemins EL, Miller-Wilson LA, Gillen A, Luo R, Colangelo F. 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;6(1):e2251384. Published 2023 Jan 3. doi:10.1001/jamanetworkopen.2022.51384. PMID: 36652246.
- Burke CA, Lieberman D, Feuerstein JD. AGA Clinical Practice Update on Approach to the Use of Noninvasive Colorectal Cancer Screening Options: Commentary. Gastroenterology. 2022;162(3):952-956. doi:10.1053/j.gastro.2021.09.075. PMID: 35094786.
- Chubak J, Garcia MP, Burnett-Hartman AN, et al. Time to Colonoscopy after Positive Fecal Blood Test in Four U.S. Health Care Systems. Cancer Epidemiol Biomarkers Prev. 2016;25(2):344-350. doi:10.1158/1055-9965.EPI-15-0470. PMID: 26843520.
- Llovet D, Serenity M, Conn LG, et al. Reasons For Lack of Follow-up Colonoscopy Among Persons With A Positive Fecal Occult Blood Test Result: A Qualitative Study. Am J Gastroenterol. 2018;113(12):1872-1880. doi:10.1038/s41395-018-0381-4. PMID: 30361625.
- May FP, Yano EM, Provenzale D, et al. Barriers to Follow-up Colonoscopies for Patients With Positive Results From Fecal Immunochemical Tests During Colorectal Cancer Screening. Clin Gastroenterol Hepatol. 2019;17(3):469-476. doi:10.1016/j.cgh.2018.05.022. PMID: 29857147.
- Khoong EC, Rivadeneira NA, Pacca L, et al. Extent of Follow-Up on Abnormal Cancer Screening in Multiple California Public Hospital Systems: A Retrospective Review. J Gen Intern Med. 2023;38(1):21-29. doi:10.1007/s11606-022-07657-4. PMID: 35641722.
- Breen N, Skinner CS, Zheng Y, et al. Time to Follow-up After Colorectal Cancer Screening by Health Insurance Type. Am J Prev Med. 2019;56(5):e143-e152. doi:10.1016/j.amepre.2019.01.005. PMID: 31003603.
- Murphy DR, Wu L, Thomas EJ, Forjuoh SN, Meyer AN, Singh H. Electronic Trigger-Based Intervention to Reduce Delays in Diagnostic Evaluation for Cancer: A Cluster Randomized Controlled Trial. J Clin Oncol. 2015;33(31):3560-3567. doi:10.1200/JCO.2015.61.1301. PMID: 26304875.
- Haas JS, Atlas SJ, Wright A, et al. Multilevel Follow-up of Cancer Screening (mFOCUS): Protocol for a multilevel intervention to improve the follow-up of abnormal cancer screening test results. Contemp Clin Trials. 2021;109:106533. doi:10.1016/j.cct.2021.106533. PMID: 34375748.
- Mahmood S, Farooqui SM, Madhoun MF. Predictors of inadequate bowel preparation for colonoscopy: a systematic review and meta-analysis. Eur J Gastroenterol Hepatol. 2018;30(8):819-826. doi:10.1097/MEG.0000000000001175. PMID: 29847488.
- Chen G, Zhao Y, Xie F, et al. Educating Outpatients for Bowel Preparation Before Colonoscopy Using Conventional Methods vs Virtual Reality Videos Plus Conventional Methods: A Randomized Clinical Trial. JAMA Netw Open. 2021;4(11):e2135576. Published 2021 Nov 1. doi:10.1001/jamanetworkopen.2021.35576. PMID: 34807255.
- Atlas SJ, Tosteson ANA, Wright A, et al. A Multilevel Primary Care Intervention to Improve Follow-Up of Overdue Abnormal Cancer Screening Test Results: A Cluster Randomized Clinical Trial. JAMA. 2023;330(14):1348-1358. doi:10.1001/jama.2023.18755. PMID: 37815566.
- Coronado GD, Ferrari RM, Barnes A, et al. Characteristics of patient navigation programs in the Cancer Moonshot ACCSIS colorectal cancer screening initiative. J Natl Cancer Inst. 2023;115(6):680-694. doi:10.1093/jnci/djad032. PMID: 36810931.
- Escoffery C, Fernandez ME, Vernon SW, et al. Patient Navigation in a Colorectal Cancer Screening Program. J Public Health Manag Pract. 2015;21(5):433-440. doi:10.1097/PHH.0000000000000132. PMID: 25140407.
- Janahiraman S, Tay CY, Lee JM, et al. Effect of an intensive patient educational programme on the quality of bowel preparation for colonoscopy: a single-blind randomised controlled trial. BMJ Open Gastroenterol. 2020;7(1):e000376. doi:10.1136/bmjgast-2020-000376. PMID: 32371502.
- Murphy DR, Meyer AND, Vaghani V, et al. Development and Validation of Trigger Algorithms to Identify Delays in Diagnostic Evaluation of Gastroenterological Cancer [published correction appears in Clin Gastroenterol Hepatol. 2019 May;17(6):1218. doi: 10.1016/j.cgh.2019.03.039]. Clin Gastroenterol Hepatol. 2018;16(1):90-98. doi:10.1016/j.cgh.2017.08.007. PMID: 28804030.
- Fendrick AM, Kisiel JB, Brooks D, et al. A Call to Action to Increase Uptake of Follow-Up Colonoscopy After Initial Positive Stool-Based Colorectal Cancer Screening. Popul Health Manag. 2023;26(6):448-450. doi:10.1089/pop.2023.0199. PMID: 37930304.
- Fendrick AM, Princic N, Miller-Wilson LA, et al. . Out-of-pocket costs for colonoscopy after noninvasive colorectal cancer screening among US adults with commercial and Medicare insurance. JAMA Netw Open 2021;4:e2136798. PMID: 34854909.
- Insurance Coverage for Colorectal Cancer Screening. American Cancer Society. Updated January 29, 2024. Accessed October 31, 2024. https://www.cancer.org/cancer/types/colon-rectal-cancer/detection-diagnosis-staging/screening-coverage-laws.html.
Measure Impact
The anticipated impact has been described in the Evidence of Measure Importance, above. The benefits of adhering to universal colorectal cancer screening recommendations outweighs any potential unintended consequences related to screening.
There is currently one endorsed quality measure related to colorectal cancer screening:
- Colorectal Cancer Screening (Higher rate = better): “Percentage of patients aged 45-75 years who had appropriate screening for colorectal cancer” (NQF #0034, Quality ID #113)
This clinical quality measure quantifies the initial step of the colorectal cancer screening process; the eCQM submitted for endorsement complements this measure by reporting the percentage of patients that completed the multi-step diagnostic process after an initial positive stool-based test result.
Three provider interviews have been conducted to date. More interviews are underway with a target of 5-10 provider and 5-10 patient interviews. Feedback was also obtained at Technical Expert Panel (TEP) meetings and through a Public Comment period.
Provider Interviews:
Providers agreed with using stool-based tests for the measure as they are widely used and applicable to lower resource environments. Similarly, there was agreement with the measure exclusion and exception criteria. Following an index positive stool-based test, the provider will recommend the patient undergo a diagnostic colonoscopy. After communication of results with the patient, one provider stated, “you will coordinate with GI, or you'll put in the order for that patient.” Delays in follow-up colonoscopies can be attributed to barriers on the patient side such as hesitancy, work obligations, or transportation but one provider identified health system capacity as a significant barrier, “GI is so backlogged, it is hard to get them done.” One provider stated, “there is some value to [measuring] at a system level because you need processes in place for diagnostic colonoscopy to be finished.” The provider suggested “having navigators to help patients find an appointment. There are other structural things but I don't think for me as a PCP would change anything.” The providers’ perspectives suggested utility of the eCQM to drive quality improvement at the hospital and health system levels.
Patient Perspective on the TEP:
One patient stated that "you can get lost in the system" when trying to schedule a colonoscopy, and expressed that it is unclear who can help navigate patients through this process. They reported barriers around scheduling, "one of the things that I’m concerned about is the ability to schedule things because it seems to be somewhat of a barrier at times," and encouraged identifying additional barriers to colonoscopy to inform interventions aimed at increasing timely follow-up.
Public Comment Feedback:
The eCQM specifications and preliminary rates were posted for Public Comment on the Centers for Medicare & Medicaid Services (CMS) Measures Management System (MMS) for 15 days. The posting was shared via email with CMS listserv members for wider distribution of the commenting opportunity.
Comments were received from the following organizations expressing support for the eCQM and providing feedback on the specifications: American College of Gastroenterology (ACG), American Medical Association (AMA), American Society for Gastrointestinal Endoscopy (ASGE), Guardant Health, HealthHIV & the National Coalition for LGBTQ Health, and Merck. Comments and feedback were used to revise measure specifications and select benchmarks as described in the supplemental attachment "4705e_Supplemental_Information.docx." Comments around meaningfulness included:
“We agree with the importance of this measure and find it well specified… This measure is appropriate for measurement at the facility level within an integrated health system, as supported by the level of analysis.” – American College of Gastroenterology (ACG) and American Society for Gastrointestinal Endoscopy (ASGE)
“The American Medical Association appreciates the opportunity to comment on the two measures addressing timely follow-up after an abnormal screening result and supports their intent… We agree that measurement should be at the facility level, assuming that testing demonstrates that the results are reliable and valid, and subsequently selected for those programs for which that level is appropriate.” – American Medical Association (AMA)
“We write to you in support of the development process for the proposed electronic Clinical Quality Measure (eCQM) on Timely Follow-up on Positive Stool-based Screening Tests for Colorectal Cancer Detection. We agree that timely completion of a follow-up colonoscopy after an abnormal noninvasive colorectal cancer (CRC) screening test is an integral part of the screening process.” – Guardant Health
“Merck strongly supports the proposed quality measure for timely follow-up on positive screening tests for colorectal cancer. This measure, aligned with established clinical guidelines, emphasizes the importance of prompt diagnostic evaluation and enables the initiation of effective therapies at a stage when they can have the greatest impact. Early detection and linkage to treatment are critical in improving survival rates and quality of life for patients and this measure provides a structured approach to achieving these goals. Moreover, it opens opportunities for personalized treatment plans, enhancing patient outcomes and supporting long-term health.” – Merck
Performance Gap
Table 1 (in attachment "4705e_PerformanceGap") presents eCQM performance rates for Health System 1 at the integrated delivery system level by year. Table 2 (in attachment "4705e_PerformanceGap") shows the eCQM rates at Health System 1 by hospital-affiliated facility group and by year. Table 3 (in attachment "4705e_PerformanceGap") presents eCQM performance rates for Health System 2 at the integrated delivery system level by year.
All eCQM performance rates were statistically significantly lower than the 95% benchmark set by the American Gastroenterological Association (AGA) above. This eCQM provides an assessment of integrated delivery system and hospital affiliated facility group capacity to complete timely diagnostic evaluation with colonoscopy. Literature estimates that 10-15% of colonoscopies are completed outside of the health system where the positive stool-based test was performed and resulted. Therefore, it may be appropriate to apply a benchmark accommodating out-of-system follow-ups, such as 80% benchmark for in-system follow-up.
Even with a reduced 80% benchmark, neither Health System 1 nor 2 met this level of performance over the period of reporting. There were substantial (non-significant) increases in the eCQM rates for two hospital-affiliated facility groups in 2023, with the Facility Group 6 eCQM performance rate of 71.7 (59.5, 83.9) not being statistically different from the 80% benchmark, indicating that performance at this level is achievable.
Please note that it was not possible to provide the performance scores by decile. This is a new eCQM that was tested at two health systems to-date with a total of 2 integrated delivery system eCQM performance rates reported (Health systems 1 and 2) and 6 facility-group eCQM performance rates reported (Health System 1).
Equity
Equity
The eCQM performance rates were calculated stratified by age at index positive stool-based test, sex, race, ethnic group, primary insurance at index positive stool-based test, primary language, and type of stool-based test (Table 15 in supplemental attachment "4705e_SupplementalInformation.docx"). A model was used to calculate the rates and 95% CIs while clustering by facility group. P-values were used to assess for significant differences in rates.
There were significant differences by primary insurance (p<.01) and type of stool-based test (p<.0001). Notably, there was substantial missing data for primary insurance at index positive stool-based test (31.9%) and the majority (~90%) with missing insurance data were Cologuard tests. Additional work is underway to accurately extract the insurance data for Cologuard tests.
Patients who completed Cologuard tests were significantly more likely to receive a timely Colonoscopy (59.9%), as compared with patients that completed Guaiac (51.8%) or Fecal Immunochemical Tests (49.5%). These findings align with the published literature.
Similar analyses were conducted for each of the 6 facility groups (Table 16 in supplemental attachment "4700e_SupplementalInformation.docx"). Facility Group 3 showed significant differences in rates by ethnic group and primary language; patients with unreported ethnic group and patients with a primary language other than English or Spanish had significantly lower rates of timely colonoscopy.
Feasibility
Feasibility
Table 8 (in supplemental attachment "4705e_SupplementalInformation.docx") presents the frequency of data elements by Health System. Table 9 (in supplemental attachment "4705e_SupplementalInformation.docx") presents the frequency of data elements for the 6 facility groups at Health System 1. All required data elements are routinely collected during patient care.
All facilities within health systems had the same feasibility scores (Scorecards 1, 2 and 3 in attachment "4705e_FeasibilityScorecard.xlsx").
Feasibility assessments did not impact final measure specifications. All data required to calculate the measure were available in routinely collected structured fields.
Proprietary Information
Scientific Acceptability
Testing Data
Health System 1 data were used for reliability and validity testing. The analyses were conducted using data routinely collected and documented in the Epic EHR and reported for six years (2018 to 2023).
None.
Table 10 (in supplemental attachment "4705e_SupplementalInformation.docx") presents health system characteristics and overall eCQM rates. In Health System 1, one hospital-affiliated facility group had 4 facilities, two groups had 3 facilities, two groups had 2 facilities, and one group had 1 facility.
Tables 11 and 13 (in supplemental attachment "4705e_SupplementalInformation.docx") show the patient and test characteristics for the included and excluded samples by health system, respectively. Tables 12 and 14 (in supplemental attachment "4705e_SupplementalInformation.docx") show the patient and test characteristics for the included and excluded samples for the 6 facility groups at health system 1, respectively.
Reliability
Patient-level Data Element Percentage Agreement and Kappa: Chart reviews were conducted on a random sample of 100 patients to calculate inter-abstractor reliability for data elements of the numerator, denominator, and excluded populations. Manual chart review was considered the gold standard. Chart reviewers were blinded to the eCQM data extractions. Percentage agreement and Kappa were calculated for the gold-standard manual chart review abstractions and the eCQM automated data extractions. For the denominator data elements, inter-abstractor agreement required agreement on three elements: whether an eligible stool-based test was resulted, result date, and whether result was positive. For the numerator data elements, inter-abstractor agreement required agreement on two elements: whether a colonoscopy was performed and colonoscopy date. For denominator exclusion and exception data elements, inter-abstractor agreement required agreement on at least one element indicating that the patient met an exclusion criterion.
Accountable Entity-level Signal-to-Noise Analysis: Signal-to-Noise Ratios (SNR) were calculated for the six hospital-affiliated facility groups at Health System 1. The signal-to-noise analysis estimated the proportion of overall variability explained by the differences between measured entities (i.e., hospital-affiliated facility groups). A minimum sample size of 10 patients was required for the signal-to-noise analysis. The results are reported overall and by year from 2018 to 2023, since the measure is intended to be reported annually. This analysis was only conducted at the facility group level given that this is a new eCQM and only two performance rates were available at the integrated delivery system level.
Patient-level Data Element Percentage Agreement and Kappa: From the random sample of 100 patients, 8 were excluded from the denominator, 92 were included in the denominator, and 56 were included in the numerator. The percentage agreements between the gold-standard manual chart review abstractions and the eCQM automated data extractions were 100% with Kappas of 1.0 for each level of analysis (i.e., denominator data elements, numerator data elements, and denominator exclusion and exception data elements).
Accountable Entity-level Signal-to-Noise Analysis: The SNRs are provided in Table 4 (in attachment "4705e_ReliabilityTestingResults.docx"). Overall, the median SNR was 0.715 (95% CI: 0.662, 0.763) for the six hospital-affiliated facility groups at Health System 1. The minimum SNR was 0.076 and the maximum SNR was 0.976. The SNRs increased over time from 2018 to 2023. The median SNR for 2023, which is most reflective of current performance, was 0.911 (95% CI: 0.860, 0.971) for the six hospital-affiliated facility groups. The minimum SNR was 0.859 and the maximum SNR was 0.971 in 2023.
Please note that it was not possible to provide the performance scores by decile. This is a new eCQM that was tested at two health systems to-date with a total of 2 integrated delivery system eCQM performance rates reported (Health systems 1 and 2) and 6 facility-group eCQM performance rates reported (Health System 1).
Patient-level Data Element Percentage Agreement and Kappa: The 100% agreements and Kappas of 1.0 demonstrated excellent reliability between the gold-standard manual chart review abstractions and the eCQM automated data extractions. These results indicate that the eCQM reliably abstracted data to define the numerator, denominator, and excluded populations.
Accountable Entity-level Signal-to-Noise Analysis: The median SNR of 0.911 (95% CI: 0.860, 0.971) in 2023 indicated that a high proportion of overall variability was explained by the differences between measured entities (i.e., hospital-affiliated facility groups) that year. The increased median SNR and narrower confidence intervals can be attributed to larger sample sizes and increased variability between hospital-affiliated facility groups in 2023.
Validity
Patient-level Data Element Validity Percentage Agreement, Kappa, and Positive Predictive Value: Chart reviews were conducted on a random sample of 100 patients to assess whether the eCQM appropriately allocated patients into the numerator, denominator only, or excluded to calculate the eCQM rates. Manual chart review was considered the gold standard. Chart reviewers were blinded to the eCQM automated allocations and reviewed the full chart to assess whether each patient should be included in the numerator or denominator only, or excluded from the measure. Percentage agreement and Kappa were calculated between the gold-standard manual chart review allocations and the eCQM automated allocations. The Positive Predictive Value (PPV) of the denominator was also calculated to quantify the proportion of patients included in the denominator that required short-term follow-up with a colonoscopy. Health Systems 2 and 3 are in the process of conducting chart reviews.
Accountable Entity-level Face Validity: The objective of face validity testing was to demonstrate that this measure would be meaningful and beneficial to providers, patients, and informatics professionals, from the perspective of experts in the field. As a part of the validity testing process, we provided the Technical Expert Panel (TEP) with several opportunities throughout the measure development process to suggest improvements and refinements to the measure. The TEP consisted of six members, representing the patient experience and expertise in medicine, measure development, quality and safety of care, cancer screening, health services research, and EHRs. During a July 2024 meeting, the TEP was presented with final measure specifications and revised rate calculations at the integrated health system level and the hospital (i.e., hospital-affiliated facility group level). The TEP also had an opportunity to discuss questions and provide feedback to the measure development team at this time. A formal face validity vote was conducted using the polling function in Zoom. The TEP was asked to agree (vote YES) or disagree (vote NO) on the following two statements:
- The Timely Follow-up on Positive Stool-based Screening Tests for Colorectal Cancer Detection – eCQM, as specified at the integrated health system level, can be used to distinguish good from poor quality care.
- The Timely Follow-up on Positive Stool-based Screening Tests for Colorectal Cancer Detection – eCQM, as specified at the hospital level, can be used to distinguish good from poor quality care.
TEP members were blinded to individual member responses but were told the final face validity vote results after eligible members had voted.
Accountable Entity-level Spearman’s Rank Correlation Coefficients and Interclass Correlation Coefficients: A random half split correlation was conducted at the hospital-affiliated facility group level at Health System 1, with six facility groups included in the analysis. To perform a random half split correlation analysis, we required a minimum of 20 patients for each facility group per year (10 patients in each split sample). Patients in each clinician group were randomly split by facility group and year into a test group or a validation group, with ~50% of patients in each group. The descriptive statistics and p-values for each group were calculated. Spearman’s rank correlation coefficients and Interclass Correlation Coefficients (ICC) were calculated with 95% confidence intervals. The ICCs were calculated to describe how much variation in the facility group level scores was due to facility group level signal variation. The Spearman’s rank correlation coefficients were calculated to compare the relative rankings of facility groups in the test and validation samples. The Spearman’s rank correlation coefficients were reported overall and by year, since the measure is intended to be reported annually. These analyses were only conducted at the facility group level given that this is a new eCQM and only two performance rates were available at the integrated delivery system level.
Patient-level Data Element Validity Percentage Agreement, Kappa, and Positive Predictive Value: From the random sample of 100 patients, 8 were excluded from the denominator, 36 were included in the denominator only, and 56 were included in the numerator. The percentage agreement between the gold-standard manual chart review allocations and the eCQM automated allocations was 100% with a Kappa of 1.0. The PPV of the denominator was 100%.
Accountable Entity-level Face Validity: At the July 2024 TEP meeting, members were asked to agree (vote YES) or disagree (vote NO) on the following two statements:
- The Timely Follow-up on Positive Stool-based Screening Tests for Colorectal Cancer Detection – eCQM, as specified at the integrated health system level, can be used to distinguish good from poor quality care.
- The Timely Follow-up on Positive Stool-based Screening Tests for Colorectal Cancer Detection – eCQM, as specified at the hospital level, can be used to distinguish good from poor quality care.
The final vote for #1 was 6/6 members (100%) in agreement with the statement at the integrated health system level.
The final vote for #2 was 5/6 members (83.3%) in agreement with the statement at the hospital level. Additional data to address feedback and concerns was provided to two TEP members that did not initially agree with the statement for review. The data showed that 88% to 100% of patients received both screening and follow-up within the same hospital-affiliated facility group for 4 facility groups in 2023. Based on this evaluation the two facility groups with lower coverage (47% and 78%) could consider reporting together given their high level of collaboration, which would result in 93% of patients receiving both screening and follow-up within the same hospital-affiliated facility group. One TEP member changed their vote to agree with the statement and no response has been received from the other TEP member yet.
Accountable Entity-level Spearman’s Rank Correlation Coefficients and Interclass Correlation Coefficients: The six facility groups from Health System 1 were included for years 2018 to 2023. 2,398 patients were included in the test sample, and 2,414 patients were included in the validation sample (Tables 5a-g in attachment "4705e_ValidityTestingResults.docx"). The eCQM rate of timely colonoscopy was 56.3% and 56.2% in the test and validation samples, respectively. P-values were calculated for patient-level demographic characteristics and type of stool-based test received; there were no significant differences between test and validation samples. The overall Spearman’s rank correlation coefficient was 0.36 (95% CI: 0.04, 0.62) (Table 6 in attachment "4705e_ValidityTestingResults.docx"). The correlations were very low in 2020-2021 and improved for 2022-2023. The Spearman’s rank correlation coefficient for 2023, which is most reflective of current performance, was 0.83 (95% CI: -0.03, 0.98). The overall ICC was 0.025 (95% CI: 0.008, 0.243) in the test sample and 0.037 (95% CI: 0.013-0.302) in the validation sample (Table 7 in attachment "4705e_ValidityTestingResults.docx"). There were no apparent trends over time.
Patient-level Data Element Validity Percentage Agreement, Kappa, and Positive Predictive Value: The 100% agreement, Kappa of 1.0, and PPV of 100% demonstrated strong validity of the eCQM automated allocations and ability to calculate accurate eCQM rates.
Accountable Entity-level Face Validity: Face validity was established by a panel of experts who agreed that the measure can be used to distinguish good from poor quality care at the integrated health system level. The majority of TEP members agreed that the measure can be used to distinguish good from poor quality care at the hospital (i.e., facility group) level. Additional data has been shared with TEP members to address feedback and concerns. No responses have been received yet.
Accountable Entity-level Spearman’s Rank Correlation Coefficients and Interclass Correlation Coefficients: The Spearman’s rank correlation coefficient of 0.83 (95% CI: -0.03, 0.98) indicated a strong positive correlation between the test and validation samples. The increased correlation can be attributed to increased variability between hospital-affiliated facility groups in 2023. However, the 95% CI is very wide given that only six facility groups were included in the analysis. Additional facility group data is required to generate narrower confidence intervals. The overall ICCs were low at 0.025 (95% CI: 0.008, 0.243) in the test sample and 0.037 (95% CI: 0.013-0.302) in the validation sample, indicating that a low proportion of variation in the facility group level scores was due to facility group level signal variation. Notably, the 95% CIs were very wide given that only six facility groups were included in the analysis. Additional facility group data is required to generate narrower confidence intervals.
Risk Adjustment
Use & Usability
Use
Usability
Rates of timely follow-up colonoscopy within 180 days of a positive stool-based test can improve with reductions in site-related barriers to timely follow-up [1, 2]. Facilities and organizations that are collecting measurement data can take steps to implement standard protocols directing clinical workflow for effective coordination of care in patients needing follow-up [3]. Evidence-based interventions that have had an observable impact on decreasing time to follow-up include patient navigation and case management, patient education on adequate bowel preparation to prevent further delays in colonoscopy, timely communication of screening and follow-up results to avoid prolonged initiation of any necessary treatment, and electronic health record (EHR) reminders to primary care providers and care coordinators [3, 4, 5, 6, 7, 8]. EHR-based trigger algorithms have also accurately identified screening eligible patients needing timely follow-up and reduced delays in colonoscopy uptake [9, 10].
Furthermore, there are no standard requirements in place to track the rates of timely follow-up colonoscopy after positive stool-based testing [3, 9, 11, 12, 13, 14, 15]. Therefore, data quality and reporting may vary among facilities seeking to report their measurements. Some facilities lack interoperable EHRs that allow for the exchange of patient data to track follow-up between facilities and health care systems [16]. Measurement entities must promote improvements in interoperability between EHRs to increase the accuracy of data used to report the rates of timely follow-up colonoscopy since data quality may ultimately influence the implementation of tailored interventions for demographics that are more likely to miss opportunities for timely follow-up [16].
- Burke CA, Lieberman D, Feuerstein JD. AGA Clinical Practice Update on Approach to the Use of Noninvasive Colorectal Cancer Screening Options: Commentary. Gastroenterology. 2022;162(3):952-956. doi:10.1053/j.gastro.2021.09.075. PMID: 35094786.
- Khoong EC, Rivadeneira NA, Pacca L, et al. Extent of Follow-Up on Abnormal Cancer Screening in Multiple California Public Hospital Systems: A Retrospective Review. J Gen Intern Med. 2023;38(1):21-29. doi:10.1007/s11606-022-07657-4. PMID: 35641722.
- Haas JS, Atlas SJ, Wright A, et al. Multilevel Follow-up of Cancer Screening (mFOCUS): Protocol for a multilevel intervention to improve the follow-up of abnormal cancer screening test results. Contemp Clin Trials. 2021;109:106533. doi:10.1016/j.cct.2021.106533. PMID: 34375748.
- Chen G, Zhao Y, Xie F, et al. Educating Outpatients for Bowel Preparation Before Colonoscopy Using Conventional Methods vs Virtual Reality Videos Plus Conventional Methods: A Randomized Clinical Trial. JAMA Netw Open. 2021;4(11):e2135576. Published 2021 Nov 1. doi:10.1001/jamanetworkopen.2021.35576. PMID: 34807255.
- Atlas SJ, Tosteson ANA, Wright A, et al. A Multilevel Primary Care Intervention to Improve Follow-Up of Overdue Abnormal Cancer Screening Test Results: A Cluster Randomized Clinical Trial. JAMA. 2023;330(14):1348-1358. doi:10.1001/jama.2023.18755. PMID: 37815566.
- Coronado GD, Ferrari RM, Barnes A, et al. Characteristics of patient navigation programs in the Cancer Moonshot ACCSIS colorectal cancer screening initiative. J Natl Cancer Inst. 2023;115(6):680-694. doi:10.1093/jnci/djad032. PMID: 36810931.
- Escoffery C, Fernandez ME, Vernon SW, et al. Patient Navigation in a Colorectal Cancer Screening Program. J Public Health Manag Pract. 2015;21(5):433-440. doi:10.1097/PHH.0000000000000132. PMID: 25140407.
- Janahiraman S, Tay CY, Lee JM, et al. Effect of an intensive patient educational programme on the quality of bowel preparation for colonoscopy: a single-blind randomised controlled trial. BMJ Open Gastroenterol. 2020;7(1):e000376. doi:10.1136/bmjgast-2020-000376. PMID: 32371502.
- Murphy DR, Wu L, Thomas EJ, Forjuoh SN, Meyer AN, Singh H. Electronic Trigger-Based Intervention to Reduce Delays in Diagnostic Evaluation for Cancer: A Cluster Randomized Controlled Trial. J Clin Oncol. 2015;33(31):3560-3567. doi:10.1200/JCO.2015.61.1301. PMID: 26304875.
- Murphy DR, Meyer AND, Vaghani V, et al. Development and Validation of Trigger Algorithms to Identify Delays in Diagnostic Evaluation of Gastroenterological Cancer [published correction appears in Clin Gastroenterol Hepatol. 2019 May;17(6):1218. doi: 10.1016/j.cgh.2019.03.039]. Clin Gastroenterol Hepatol. 2018;16(1):90-98. doi:10.1016/j.cgh.2017.08.007. PMID: 28804030.
- Issaka RB, Singh MH, Oshima SM, et al. Inadequate Utilization of Diagnostic Colonoscopy Following Abnormal FIT Results in an Integrated Safety-Net System. Am J Gastroenterol. 2017;112(2):375-382. doi:10.1038/ajg.2016.555. PMID: 28154400.
- Chubak J, Garcia MP, Burnett-Hartman AN, et al. Time to Colonoscopy after Positive Fecal Blood Test in Four U.S. Health Care Systems. Cancer Epidemiol Biomarkers Prev. 2016;25(2):344-350. doi:10.1158/1055-9965.EPI-15-0470. PMID: 26843520.
- Llovet D, Serenity M, Conn LG, et al. Reasons For Lack of Follow-up Colonoscopy Among Persons With A Positive Fecal Occult Blood Test Result: A Qualitative Study. Am J Gastroenterol. 2018;113(12):1872-1880. doi:10.1038/s41395-018-0381-4. PMID: 30361625.
- May FP, Yano EM, Provenzale D, et al. Barriers to Follow-up Colonoscopies for Patients With Positive Results From Fecal Immunochemical Tests During Colorectal Cancer Screening. Clin Gastroenterol Hepatol. 2019;17(3):469-476. doi:10.1016/j.cgh.2018.05.022. PMID: 29857147.
- Khoong EC, Rivadeneira NA, Pacca L, et al. Extent of Follow-Up on Abnormal Cancer Screening in Multiple California Public Hospital Systems: A Retrospective Review. J Gen Intern Med. 2023;38(1):21-29. doi:10.1007/s11606-022-07657-4. PMID: 35641722.
- Kaushal R. The Role of Health Information Technology in Improving Quality and Safety in Pediatric Health Care. Agency for Healthcare Research and Quality; 2012. Available from: https://digital.ahrq.gov/sites/default/files/docs/page/final-kaushal-story-7-6-12.pdf. Accessed October 31, 2024.
Comments
Staff Preliminary Assessment
4705e Staff Assessment
Importance
Strengths:
- Colorectal cancer is the second leading cause of cancer mortality in the U.S., with over 150,000 projected diagnoses in 2024. Despite guidelines recommending timely follow-up colonoscopies after positive stool-based tests, actual follow-up rates are low, around 50-56%, indicating a significant gap in the screening process.
- The developer cites evidence that despite the availability of cost-effective noninvasive stool tests, follow-up colonoscopy rates within 180 days post-positive test are low, around 51-56%. Patients without timely follow-ups are at a higher risk of late-stage cancer diagnosis.
- The American Gastroenterological Association recommends a 95% follow-up rate within six months, yet actual rates are significantly lower, especially among disadvantaged and medically underserved communities. Furthermore, the U.S. Preventive Services Task Force has called for increased follow-up rates.
- This new eCQM process measure is designed to monitor and enhance timely follow-up colonoscopies after positive non-invasive tests. The develop cites a meta-analysis noting that with a positive stool test who do not receive follow-up colonoscopy within 180 days are at a significantly increased risk of being diagnosed with late-staged cancer.
- The developer’s logic model reflects this, indicating that this measure can lead to early detection and even prevention of colorectal cancer.
- The developer states that providers encounter numerous challenges in improving timely follow-up rates, including inadequate referrals, poor patient education on bowel preparation, and insufficient EHR documentation.
- Effective interventions outlined include timely referrals to GI specialists, patient navigation, education, active outreach, and EHR-based trigger algorithms to ensure timely care and improve adherence to screening completion.
- The developer notes that current endorsed quality measure, CBE #0034, tracks initial colorectal cancer screenings for patients aged 45-75, while the proposed eCQM measures follow-up completion after a positive stool test.
- The developer notes that a gap analysis across entities couldn't be conducted due to the minimal number of entities involved; however, data from Health Systems 1 and 2 show that all eCQM performance rates were significantly below the 95% AGA benchmark. Even with a reduced 80% benchmark for in-system follow-ups, neither health system met this target, although Facility Group 6 in 2023 came close with a rate of 71.7%, indicating potential achievability.
- The developer conducted three provider interviews to date. More interviews are underway with a target of 5-10 provider and 5-10 patient interviews. Feedback was also obtained from a Technical Expert Panel (TEP) and through a public comment period.
- Within the TEP, patients expressed concerns about getting "lost in the system" when scheduling colonoscopies, pointing out scheduling difficulties as a significant barrier. They advocated for identifying and addressing additional barriers to increase timely follow-up, underscoring the need for better navigation and support throughout the process.
Limitations:
- The 180 days is supported by a recommendation from the American Gastroenterological Association, but grading was not provided in the submission for this recommendation. The developer may be able to speak to this.
- The logic model depicts the development and testing of this measure, rather than identifying the inputs and actions accountable entities should do to achieve the measure.
- However, the developer does note in Usability, section 6.2.1 that timely follow-up colonoscopy rates within 180 days of a positive stool-based test can be improved by reducing site-related barriers and implementing standard protocols for clinical workflow to effectively coordinate care. Evidence-based interventions such as patient navigation, case management, patient education on bowel preparation, timely communication of results, and EHR reminders have shown to decrease time to follow-up.
Rationale:
- This eCQM process measure for colorectal cancer screening is designed to address significant gaps in the screening process by enabling facilities to monitor and enhance the timeliness of follow-up colonoscopies after positive stool-based tests. The developer provides evidence of effective interventions that can overcome the challenges to improving follow-up rates. The 180-day follow-up period for colonoscopies, recommended by the American Gastroenterological Association, lacks grading in the submission, and the logic model focuses more on measure development than on specifying necessary actions for entities to achieve this measure.
Feasibility Acceptance
Strengths:
- As an eCQM, all data elements are in electronic format.
- All required data elements for the measure are routinely collected, ensuring consistency in data availability.
- Feasibility assessments across all facilities within the health systems resulted in uniform feasibility scores, indicating that the availability of data in structured fields did not impact the final specifications of the measure.
- Accurate and comprehensive data collection for quality measurement The measure is not a proprietary measure and no proprietary components.
Limitations:
- None.
Rationale:
- For this eCQM all necessary data elements are consistently collected in electronic format. The feasibility assessments conducted across these facilities yielded consistent feasibility scores, demonstrating that the structured data fields used did not influence the final specifications of the measure. The measure's non-proprietary nature ensures broad accessibility.
Scientific Acceptability
Strengths:
- Data Sources and Dates: Data used for testing were sourced from EHRs during the years 2018 to 2023.
- Patient/Encounter Level Reliability: The developer conducted inter-abstractor reliability testing at the person- or encounter-level for all critical data elements. The developer reported 100% agreement between the gold-standard manual chart review abstractions and the eCQM automated data extractions with Kappas of 1.0 for each level of analysis, which meets the expected threshold of 0.4.
- Accountable Entity Level Reliability: The developer conducted signal-to-noise reliability testing at the accountable entity-level. 100% of accountable entities exceeded the expected threshold of 0.6 in 2023 with a minimum reliability of 0.859. For the six-year period (2018-2023), at least half of the entities had a signal-to-noise reliability >0.60 with a minimum of 0.076. In 2022, at least 50% of entities had reliability >0.60. In the validity testing section, the developer conducted a random half split correlation analysis at the hospital-affiliated facility group level in Health System 1, involving six facility groups and splitting patients into test and validation groups. This analysis should have been reported in the reliaibity section. The eCQM rate for timely colonoscopy was similar between the test (56.3%) and validation (56.2%) samples, with no significant demographic differences, and the Spearman’s rank correlation coefficient improved to 0.83 in 2023, indicating a strong positive correlation. However, the wide confidence intervals and low ICCs suggest that more facility group data is needed to improve the precision of these estimates.
Limitations:
- Data Sources and Dates: The developer conducted signal-to-noise reliability testing at the accountable entity-level on six facility groups.
- Accountable Entity Level Reliability: For each year from 2018 to 2021, <50% of entities had a reliability >0.60.
Rationale:
- The results demonstrate sufficient reliability at the accountable entity level.
Strengths:
- For patient-/episode-level (data element) validity for the numerator, denominator, and exclusions the developer reports a percentage agreement between the gold-standard manual chart review allocations and the eCQM automated allocations was 100% (on a sample of 100 cases). The PPV of the denominator was also 100%. The developer also reports 100% TEP agreement with the statement that the measure cab be used at the integrated health system level to distinguish good from poor quality of care, and slightly less agreement (83.3%) that the measure might be used at the hospital level. The developer did not conduct empirical validity testing (ICC is considered a test for reliability).
Limitations
- As a new measure submission the patient-/episode-level (data element) validity testing is sufficient. However, only one EHR was used for data element testing. The accountable entity level testing, while not required, was not sufficient. For face validity, a larger TEP of at least 12 members including patient representatives and broad representation from potential measure users is preferred. In addition, a Likert scale of at least five responses is preferred to demonstrate consensus. The ICC should be reported under reliability, not validity. Further testing with additional sites is necessary for the future. The measure may only be valid within the same hospital-affiliated facility group.
Rationale:
- The validity rating is based on patient-/episode-level (data element) testing only, which is acceptable for a new eCQM. The accountable entity level testing, while not required, was not sufficient. For face validity, a larger TEP of at least 12 members including patient representatives and broad representation from potential measure users is preferred. In addition, a Likert scale of at least five responses is preferred to demonstrate consensus. The ICC should be reported under reliability, not validity. Further testing with additional sites and within at least two EHR vendors is necessary for the future.
Equity
Strengths:
- The eCQM performance rates were stratified by various demographic and clinical factors, including age, sex, race, ethnic group, primary insurance, primary language, and type of stool-based test, revealing significant differences in rates by primary insurance and type of test, with notable data gaps in insurance information for Cologuard tests. A statistical model accounting for clustering by facility group was used to calculate these rates and assess significant differences.
- Patients undergoing Cologuard tests had higher rates of timely colonoscopy (59.9%) compared to those with Guaiac (51.8%) or Fecal Immunochemical Tests (49.5%), with additional analyses across the six facility groups showing significant disparities in timely colonoscopy rates based on ethnic group and primary language, particularly in Facility Group 3.
Limitations:
- The analytic approach was not specified in the submission.
- The developer notes they will continue to monitor disparities for the most affected subgroups, but they do not specifically address unintended consequences or apply an interpretation for the results.
Rationale:
- The eCQM performance rates, stratified by demographic and clinical factors such as age, sex, race, and type of stool-based test, highlighted significant differences by primary insurance and test type, with Cologuard tests showing higher rates of timely colonoscopy (59.9%) compared to Guaiac (51.8%) or Fecal Immunochemical Tests (49.5%). Notable data gaps in insurance information for Cologuard tests were observed, and further analyses across six facility groups revealed significant disparities in timely colonoscopy rates influenced by ethnic group and primary language, especially in Facility Group 3. The developer could also provide additional information in the submission itself describing methods and exploring the interpretation of the disparities findings and how they might be used to improve health care.
Use and Usability
Strengths:
- This new measure is not currently in use, but it has a planned use for public reporting and quality improvement.
- Timely follow-up colonoscopy rates within 180 days of a positive stool-based test can be improved by reducing site-related barriers and implementing standard protocols for clinical workflow to effectively coordinate care. Evidence-based interventions such as patient navigation, case management, patient education on bowel preparation, timely communication of results, and EHR reminders have shown to decrease time to follow-up.
- Despite the effectiveness of these interventions, there is a lack of standard requirements for tracking timely follow-up rates, leading to variability in data quality and reporting among facilities. Enhancing EHR interoperability is crucial for
accurate data exchange and tracking of follow-up across different healthcare systems, which is essential for implementing targeted interventions for demographics at higher risk of delayed follow-up.
Limitations:
- None.
Rationale:
- The new measure, intended for public reporting and quality improvement, aims to improve timely follow-up colonoscopy rates within 180 days of a positive stool-based test by reducing site-related barriers and implementing standard protocols. Evidence-based interventions such as patient navigation, case management, patient education on bowel preparation, timely communication of results, and EHR reminders have shown to decrease time to follow-up
Committee Independent Review
180 days
Importance
This cancer is highly treatable and has good prognosis when caught early. It is an important measure and I even question if 180 days is to long of a time for this measure. We know that early treatment can reduce downstream costs to employers, patients/families, and payers.
Feasibility Acceptance
This is an eCQM measure and will not be burdensome because the data is already being captured.
Scientific Acceptability
Defer to my colleagues with knowledge in this field.
Defer to my colleagues.
Equity
Insurance coverage does impact equity as does permanent housing and having and address.
Use and Usability
I imagine integrated health systems like Kaiser and Geisinger will have an easier time achieving this measure. However, healthcare has to improve their communication and workflow processes and this measure can help with this.
Summary
I think 180 days is too long. If we start at 180 days can this be reduced in subsequent years to say 120, 90, 60, etc.
Comments noted.
Importance
There was only one pilot patient interview for feedback on the measure's meaningfulness. Additional patient perspectives would be helpful.
Feasibility Acceptance
Agree with staff assessment.
Scientific Acceptability
Agree with staff assessment.
The staff assessment noted that data element validity testing should occur in 2+ EHRs, but I don't see that in the guidebook.
The staff assessment also noted the TEP should include 12+ members, but that is not listed in the guidebook.
Equity
Optional.
Use and Usability
Agree with staff assessment.
Summary
Comments noted.
This is a timely measure,…
Importance
It appears that the American Gastroenterological Association recommended the 180-day follow-up. However, the developers may want to discuss and provide more information on the feasibility of decreasing the follow-up time. The main concern is whether patients will be lost to follow-up during this time and what solutions may be available to address this. This is particularly true for rural regions and elderly populations.
Feasibility Acceptance
Although the eCQM used readily and comprehensively available data across health systems, the developer should clarify if this measure involved patient participation.
Scientific Acceptability
My main concerns are the narrative's lack of clarity and the tables' lack of interpretation.
The reporting is challenging to grasp. I downloaded the supplementary file, but the data aren't easy to understand without clarification. For example, in Table 12, what do FG1, FG2, etc. mean?
Please refer to my comments above.
Equity
I commend the developers for stratifying the data by different subgroups. The developers should address how and if patients were involved in the process of developing the measure. More details about how this measure will perform within health systems in rural regions.
Use and Usability
This measure is of great importance and significance in preventing colorectal cancer morbidity and mortality.
Summary
This is a timely measure, but the 180 days is concerning.
Concerns are limited
Importance
Evidence needs grading and would encourage developer to keep exploring what the optimal number of days for f/u is. Other evidence supporting other aspects of the measure seem strong.
Feasibility Acceptance
no concerns
Scientific Acceptability
no additional concerns to staff assessment
no additional concerns to staff assessment. strongly encourage developer to ensure testing data from more diverse sites that implement is available.
Equity
I think folks are having trouble meeting this criteria! Encourage further testing as staff suggest. No additional concerns.
Use and Usability
no concerns
Summary
Agree with staff assessments and no additional concerns. Evidence needs grading and assessment of more diverse sites will help improve validity and equity analyses.
CBE #4705e
Importance
Agree with Staff Preliminary Assessment.
Feasibility Acceptance
Agree with Staff Preliminary Assessment.
Scientific Acceptability
Agree with Staff Preliminary Assessment.
Agree with Staff Preliminary Assessment.
Equity
Agree with Staff Preliminary Assessment.
Use and Usability
Agree with Staff Preliminary Assessment.
Summary
Comments noted
this is on the right track
Importance
Feels close... just needs a little more supporting documentation
Feasibility Acceptance
satisfactory
Scientific Acceptability
staff conclusion makes sense
this seems like if it isn't met then it just barely missed the mark
Equity
more uneven that other parts of the submission
Use and Usability
solid
Summary
There is a lot here to indicate that this is endorseable measure. Maybe a little more info regarding validity and importance
Public Comments
4705e Rate of Timely Follow-up on Positive Stool-based Tests
The American Medical Association appreciates the opportunity to comment on this measure addressing timely follow-up after an abnormal screening result and supports its intent. However, we have several concerns and ask that the committee consider them during their review.
The U.S. Food and Drug Administration recently approved two blood tests for CRC screening.[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.
Specifically, current evaluation criteria require developers to complete validity testing on at least two electronic health record vendor systems (EHRs) and it appears that only one system was used for the data element validity analyses.
In addition, there are the potential factors that are outside of the control of the facility 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 facility, and we believe that this measure currently does not adequately address those scenarios.
[1] https://www.cancer.org/cancer/types/colon-rectal-cancer/detection-diagnosis-staging/screening-tests-
used.html#:~:text=The%202%20FDA%2Dapproved%2C%20blood,be%20different%20for%20each%20test.
[2] https://www.medicare.gov/coverage/colorectal-cancer-blood-based-biomarker-screening-
tests#:~:text=Medicare%20covers%20a%20blood%2Dbased,available)%20once%20every%203%20years.
[3] https://www.federalregister.gov/d/2024-25382
Response to The American Medical Association
Thank you very much for taking the time to review the measure submission and provide comments.
Given recent support for blood-based biomarker screening tests for colorectal cancer screening, we agree that this is an important consideration for the eCQM. For the time periods used for eCQM testing (2018-2023), we did not have the data available to support inclusion of blood-based biomarker screening tests in the eCQM denominator. Additional data will be collected for measurement years 2024 and onwards to inform future updates to the eCQM specifications as these blood tests are adopted as a standard of care in the colorectal cancer screening continuum.
For validity testing using data from other EHRs, we are in the process of conducting formal chart reviews at Health System 2 (Cerner, now Oracle Health) and Health System 3 (Allscripts). We used an iterative process to validate the data extractions for calculation of the eCQM performance rates at these two health systems; however, we have not yet received the quantitative validity testing results.
Regarding accounting for factors outside of a facility’s control, it is our understanding that it is not the role of the developer/steward to determine the appropriate benchmark. We applied a benchmark of 80% informed by the literature, current guidelines, preliminary assessments of out-of-system and out-of-facility-group colonoscopy rates at Health System 1, and stakeholder consultations to demonstrate a substantial performance gap. We relied on the 95% benchmark proposed by the American Gastroenterological Association (AGA), and estimates from the literature that 10-15% of colonoscopies are completed outside of the health system where the positive stool-based test was performed and resulted. We also specified that the eCQM provides an assessment of integrated delivery system and hospital-affiliated facility group capacity to complete timely diagnostic evaluation with colonoscopy. Based on this information, we suggested that it may be appropriate to apply a benchmark accommodating for out-of-system/out-of-facility follow-ups, such as an 80% benchmark for in-system/in-facility follow-ups.
Comments on CBE ID: 4705e
Guardant Health appreciates the opportunity to comment on the proposed electronic Clinical Quality Measure (eCQM), Rate of Timely Follow-up on Positive Stool-based Tests for Colorectal Cancer Detection. In July 2024, Shield™ became the first blood-based test approved by the U.S. Food and Drug Administration (FDA) as a primary screening option for colorectal cancer [1] and meets the requirements for Medicare coverage [2].
New modalities of testing, like blood-based testing, have the potential to overcome many of the access barriers associated with current screening methods by incorporating CRC screening into routine medical care. For example, since the introduction of the LDT (laboratory developed test) version in May 2022, Shield™ has demonstrated a 90% adherence rate in the clinical setting [3] which means blood-based testing can be a critical tool for reaching the 50 million individuals who remain unscreened with currently available options. As highlighted by CMS in the CY 2025 Physician Fee Schedule Final Rule, “a blood test may be more accessible to many patients in rural and underserved communities than facilities that furnish screening colonoscopies, flexible sigmoidoscopies and CTC.” [4]
Similar to other non-invasive CRC screening tests, a patient with a positive (i.e., abnormal) Shield™ result should be referred for a colonoscopy evaluation to determine whether CRC is present. The follow-up colonoscopy after an abnormal result from a non-invasive test is an essential part of complete CRC screening, but completion rates are suboptimal. Notably, CMS now includes blood-based testing in the CRC screening continuum, so that Medicare patients will not experience an out-of-pocket cost for a follow-up colonoscopy after a positive blood-based screening test. [4]
Quality measurement can help improve health outcomes by encouraging healthcare providers, systems and plans to ensure patients who elect to use a non-invasive CRC option fully complete their screening. Since stool-based screening tests are no longer the only FDA-approved and Medicare-covered non-invasive CRC screening modality, we believe that the measure should be expanded to capture follow-up colonoscopy after abnormal findings from a blood-based test. This would ensure that healthcare providers are not disincentivized to use FDA-approved and Medicare-covered tests that can help close screening gaps. Furthermore, we recommend the title be revised to “Timely Follow-up on Non-invasive Screening Tests for Colorectal Cancer Detection” to be more open-ended and allow for inclusion of additional non-invasive technologies.
Guardant Health is deeply committed to making more convenient high-quality tools available to detect CRC early when it is more easily treated, and we thank you for the opportunity to comment on this proposed electronic Clinical Quality Measure.
[1] FDA Premarket Approval – Shield™ (P230009) (July 26, 2024), available here: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230009.
[2] National Coverage Determination (NCD). Colorectal Cancer Screening Tests 210.3, available here: https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=281.
[3] Raymond V, Foster G, Hong Y et al. Implementation of Blood-Based Colorectal Cancer Screening: Real-World Clinical Experience. ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.
[4] Medicare and Medicaid Programs; CY 2025 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments, available here: https://www.federalregister.gov/documents/2024/12/09/2024-25382/medicare-and-medicaid-programs-cy-2025-payment-policies-under-the-physician-fee-schedule-and-other.
Response to Guardant Health
Thank you very much for taking the time to review the measure submission and provide comments.
Given recent support for blood-based biomarker screening tests for colorectal cancer screening, we agree that this is an important consideration for the eCQM. For the time periods used for eCQM testing (2018-2023), we did not have the data available to support inclusion of blood-based biomarker screening tests in the eCQM denominator. Additional data will be collected for measurement years 2024 and onwards to inform future updates to the eCQM specifications as these blood tests are adopted as a standard of care in the colorectal cancer screening continuum.
4705e Rate of Timely Follow-up on Positive Stool-based Tests
On behalf of the American College of Gastroenterology (ACG) and American Society for Gastrointestinal Endoscopy (ASGE), thank you for the opportunity to review and provide comment on the electronic Clinical Quality Measure (eCQM) Timely Follow-up on Positive Stool-based Screening Tests for Colorectal Cancer Detection to report rates of timely follow-up after abnormal colorectal cancer (CRC) screening tests. Our societies applaud the developer for addressing this important measure topic to assist health systems and others close the loop on abnormal screening tests and improve diagnostic excellence by reducing delays in cancer diagnosis. GI cancers, including colorectal, esophageal, gastric, pancreatic, and liver cancers, benefit from early detection and intervention.
We agree that this measure is appropriate for measurement at the facility level within an integrated health system, as supported by the level of analysis. However, we do not see within the measure specifications accommodation for when patients receive a follow-up colonoscopy within 180 days outside of the system. We believe that the addition of an exception to address these cases, even if atypical, is appropriate, particularly for accountability uses such as value-based payment programs. A facility or health system’s reimbursement should not be negatively impacted when performance was indeed met.
In addition, further testing of the measure beyond the facilities in one integrated health system is warranted, specifically in integrated health systems with differing characteristics (e.g., electronic health record systems [EHRs], geographic areas), some of which may lack data interoperability and enable the developer to determine the potential to misrepresent a facility’s performance. Specifically, current evaluation criteria require developers to complete validity testing on at least two EHRs and it appears that only one system was used for the data element validity analyses. We believe that this measure must be tested across more vendor systems and facilities to ensure that it can be readily captured and produce reliable and valid results.
The range of performance reflected in the rates of the six sample sites in an integrated health system is consistent with findings by Mohl JT et al.[1], supporting inclusion of a clinical recommendation statement providing a performance target of at least ≥50% and, recognizing the exception noted above, language, which should always be included with the measure, minimizing expectations that performance should always be 100%. While we appreciate that the developer included a performance target, we believe that ≥80% is too high and benchmarks should be set based on evidence when available.
The U.S. Food and Drug Administration recently approved two blood tests for CRC screening.[2] Further, the Centers for Medicare and Medicaid Services (CMS) Medicare covers a blood-based biomarker screening test for colorectal cancer once every 3 years[3] and has proposed to expand 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.[4] 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 and therefore should be recognized in any quality measure.
Thank you for the opportunity to comment.
[1] Mohl JT, Ciemins EL, Miller-Wilson L, Gillen A, Luo R, Colangelo F. 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;6(1):e2251384. doi:10.1001/jamanetworkopen.2022.51384
[2] https://www.cancer.org/cancer/types/colon-rectal-cancer/detection-diagnosis-staging/screening-tests-used.html#:~:text=The%202%20FDA%2Dapproved%2C%20blood,be%20different%20for%20each%20test.
[3] https://www.medicare.gov/coverage/colorectal-cancer-blood-based-biomarker-screening-tests#:~:text=Medicare%20covers%20a%20blood%2Dbased,available)%20once%20every%203%20years.
[4] https://www.federalregister.gov/d/2024-25382
Response to ACG and ASGE
Thank you very much for taking the time to review the measure submission and provide comments.
The 80% benchmark was intended to accommodate for exceptions that may be outside of a facility’s control, and was informed by the literature, current guidelines, preliminary assessments of out-of-system and out-of-facility-group colonoscopy rates at Health System 1, and stakeholder consultations. We relied on the 95% benchmark proposed by the American Gastroenterological Association (AGA), and estimates from the literature that 10-15% of colonoscopies are completed outside of the health system where the positive stool-based test was performed and resulted. We also specified that the eCQM provides an assessment of integrated delivery system and hospital-affiliated facility group capacity to complete timely diagnostic evaluation with colonoscopy. Based on this information, we suggested that it may be appropriate to apply a benchmark accommodating for out-of-system/out-of-facility follow-ups, such as an 80% benchmark for in-system/in-facility follow-ups.
Regarding lowering the benchmark, the purpose of this proposed 80% benchmark was to demonstrate a substantial performance gap and this benchmark may be more appropriate for quality improvement than pay for performance programs which could specify a lower threshold. It is our understanding that it is not the role of the developer/steward to determine appropriate benchmarks for reimbursements.
For validity testing using data from other EHRs, we are in the process of conducting formal chart reviews at Health System 2 (Cerner, now Oracle Health) and Health System 3 (Allscripts), which are located in other regions of the U.S. and serve different patient populations. We used an iterative process to validate the data extractions for calculation of the eCQM performance rates at these two health systems; however, we have not yet received the quantitative validity testing results.
Given recent support for blood-based biomarker screening tests for colorectal cancer screening, we agree that this is an important consideration for the eCQM. For the time periods used for eCQM testing (2018-2023), we did not have the data available to support inclusion of blood-based biomarker screening tests in the eCQM denominator. Additional data will be collected for measurement years 2024 and onwards to inform future updates to the eCQM specifications as these blood tests are adopted as a standard of care in the colorectal cancer screening continuum.