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Widespread noncompliance with federal cost-sharing rules exists, particularly impacting Medicare beneficiaries and patient-preferred prep options, study finds.
Although the Affordable Care Act (ACA) mandates no-cost coverage for colorectal cancer (CRC) screenings—including required bowel preparation—more than half of patients with commercial insurance and 83% of Medicare beneficiaries are still paying out-of-pocket, a new analysis shows.1
The findings from this cross-sectional analysis are published in Gastroenterology.
“This study aimed to evaluate out-of-pocket costs for bowel preparations among patients enrolled in commercial and Medicare Part D plans undergoing screening colonoscopy, focusing on differences across bowel preparation volume categories (high-volume vs low-volume),” wrote the researchers of the study.
The ACA mandates that both private insurers and Medicare fully cover all CRC screening tests recommended by the US Preventive Services Task Force (USPSTF), without any out-of-pocket costs to patients.2 However, what qualifies as a “screening” test can be unclear in practice, leading to inconsistent coverage. Currently, the USPSTF recommends that individuals at average risk begin CRC screening at age 45 years.
The study analyzed prescription drug claims for bowel preparation products linked to screening colonoscopies using IQVIA medical and pharmacy claims data from May 2022 to April 2023.1 Researchers identified eligible claims from commercial, Medicare Part D, and Medicaid payers using colonoscopy procedure codes associated with corresponding bowel prep prescriptions. Bowel preparations were categorized as high-volume or low-volume, with both branded and generic products included. Over-the-counter preparations, such as polyethylene glycol mixed with sports drinks (PEG-SD), were noted as commonly used but excluded due to the absence of prescription claims data.
For each payer type, the study calculated the percentage of claims with zero out-of-pocket costs and reported median out-of-pocket costs for non-zero claims, stratified by bowel prep volume.
More than 2.5 million bowel preparation prescription claims were included, with 52.9% from commercial plans, 35.0% from Medicare Part D, and 8.3% from Medicaid. Overall, most claims involved patient cost-sharing: 53% for commercial, 83% for Medicare Part D, and 27% for Medicaid.
Low-volume preparations were consistently more likely to incur out-of-pocket costs than high-volume products across all payer types. Among commercial claims, 61% of low-volume and 35% of high-volume preparations had out-of-pocket costs. In Medicare, 90% of low-volume and 75% of high-volume claims involved cost-sharing. Medicaid showed the narrowest gap, with 30% of low-volume and 27% of high-volume claims having out-of-pocket costs. Among claims with non-zero cost-sharing, median out-of-pocket amounts were higher for low-volume products across all payers—reaching $60 for both commercial and Medicaid and $55.99 for Medicare—compared with $10, $1, and $8, respectively, for high-volume options.
However, the researchers noted several limitations. First, it relied solely on claims data, which do not capture patient characteristics, clinical factors influencing bowel prep selection, or actual completion of colonoscopies. Over-the-counter bowel preparations, such as PEG mixed with sports drinks, were not included in the analysis, potentially underestimating true patient costs. Additionally, variations in plan-specific benefits and pharmacy pricing were not assessed, and the study could not distinguish between Medicare Advantage and standalone Part D plans.
Despite these limitations, the researchers believe the study suggests that unexpected costs disproportionately affect access for underserved groups and discourage use of low-volume prep solutions that are easier to tolerate, threatening progress toward national screening goals and equity in preventive care.
“Study findings emphasize the need for consistent enforcement of ACA compliance in health plans and for payer practices to align with evidence-based bowel preparation guidelines in order to support effective screening,” wrote the researchers. “It is crucial for CMS to reaffirm its 2016 guidance, stating that colonoscopy preparations must be covered at no cost to patients. Strengthening adherence to this mandate would improve access, increase CRC screening rates, and promote equitable preventive care.”
References
1. Shah ED, Calderwood AH, McBride K, et al. Out-of-pocket costs for colonoscopy prep persist despite ACA mandate: Insights from a large real-world dataset. Gastroenterology. Published online June 20, 2025. doi:10.1053/j.gastro.2025.05.025
2. Insurance coverage for colorectal cancer screening. American Cancer Society. Updated February 27, 2025. Accessed June 20, 2025. https://www.cancer.org/cancer/types/colon-rectal-cancer/detection-diagnosis-staging/screening-coverage-laws.html
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