It is the position of the American Cancer Society (ACS) that cancer screening should be understood as a continuum of testing rather than a single recommended screening test, and that irrespective of individual risk, screening is a process that includes a recommended screening test and all follow-up tests described as diagnostic and judged to be integral and necessary to resolve the question of whether an adult undergoing screening has cancer. These tests should be covered without any patient cost-sharing consistent with the 2022 FAQ specifying no patient cost-sharing for follow-up colonoscopy after a positive non-colonoscopy colorectal cancer screening examination, and in accordance with the requirements of PHS Act section 2713 and its implementing regulations.1 This principle also applies to asymptomatic adults who have been designated as higher risk based on risk factors or prior screening examination findings, and thus have faced cost-sharing for regular interval screening, more frequent screening, supplemental imaging, or surveillance examinations. Insurers must cover and should not impose cost-sharing for these recommended examinations, regardless of the patient’s designated risk.
Death from cancer is the leading cause of premature mortality in the US, with an estimated 9.3 million person-years of life were lost in 2018 due to deaths from cancer; 45% of this premature mortality was due to deaths from lung and bronchus cancer (2,114,000 yrs.), colorectal cancer (827,000 yrs.), breast cancer (781,000 yrs.), and cervical cancer (108,000 yrs.), for which cancer screening is recommended by the ACS and the USPSTF, and prostate cancer (319,000 yrs.), for which men are advised to make individualized decisions.28 In addition to the enormity of these estimates of premature mortality, many years of diminished quality of life experienced by patients who are diagnosed with advanced cancer must be included in considering the burden of this disease.
The goal of cancer screening is to reduce the incidence rate of advanced cancer through the detection of occult disease in asymptomatic adults. When cancers of the breast, cervix, colon & rectum, lung, and prostate are diagnosed early, treatment is more successful, less debilitating, often less costly, and associated with substantial reductions in cancer-related disability and death.2, 3
There is a common misconception about cancer screening, i.e., that cancer screening is a single test with a positive or negative finding. In fact, it should be viewed as a process that begins with a screening test. If the test is positive, it simply means that additional testing is needed. This cascade of testing should be considered as integral to screening, i.e., as part of the continuum of screening rather than conceptualized as two distinct clinical activities (screening vs. diagnostic). The screening continuum is the process during which a patient with a positive screening test continues testing until they can be told they do, or do not, have cancer. Most patients will be told they do not have cancer, a smaller number will be told that they do, but failure to follow up a positive screening test leaves the patient without an answer to that key question, and with the full potential of cancer screening unfulfilled, or lost altogether.
For many years, the ACS expressed concerns that patients undergoing stool testing for colorectal cancer who had a positive screening test result faced cost barriers to follow-up colonoscopy. Given the difference between a stool test and colonoscopy, which is a direct visual exam of the entire colon, the ACS made the argument that a patient with a positive stool test had not completed the process of screening until they had a colonoscopy, and the colonoscopy should be covered with no out-of-pocket-costs in keeping with the objective of the Patient Protection and Affordable Care Act (ACA) to remove cost barriers to screening.4 In 2018, the ACS published A blueprint for cancer screening and early detection: Advancing screening's contribution to cancer control, and summarized the provisions in the ACA that eliminated cost-sharing for USPSTF recommended A and B rated screening tests, but added: “the recent ACA provision has been criticized for not fully addressing circumstances that allow the imposition of cost sharing on screening and diagnostic procedures.”5 One common circumstance that affects the costs of screening is that abnormal findings on initial screens almost always generate the need for additional evaluation, which may include immediate imaging studies of the suspicious area after an abnormal mammogram; follow-up colonoscopy after an abnormal non-colonoscopic screening exam; colposcopy after abnormal cervical cancer screening; short-term follow-up imaging and biopsy for an individual with an elevated PSA; and immediate follow up or short-term follow up for an individual with an abnormal finding on lung cancer screening; etc. These supplemental tests are often treated by insurers as diagnostic tests, and not part of the screening continuum, and thus are subject to cost-sharing. In addition, a history of nonmalignant abnormalities on imaging, a history of colorectal polyps, a family history of cancer, or a condition, such as significant mammographic breast density, etc., or simply a clinician’s judgment that a patient is higher-than-average risk, may result in an asymptomatic patient receiving regular screening or more frequent screening or surveillance tests that are coded as diagnostic and thus is not eligible for full coverage free of cost-sharing under the ACA.5
In the 2018 update of the ACS colorectal cancer screening guideline, the section on Patient considerations of cost and reimbursement also addressed the issue of cost-sharing imposed on patients undergoing screening. The ACS noted that: (1) patients covered by Medicare currently incur costs if a polyp is removed; (2) patients with commercial insurance may still be charged inappropriately for polyp removal during a screening exam; (3) if a patient is first screened with a stool test or any other noncolonoscopy examination, then most insurers interpret a colonoscopy performed to follow up a positive initial screen as a diagnostic procedure subject to cost-sharing; and (4) some insurers have judged a personal history of cancer, polyps, or a family history as defining all colorectal cancer screening as diagnostic and subject to cost-sharing, especially if these screening exams are performed at shorter intervals than were recommended by the USPSTF for average-risk adults. Specific to the imposition of cost-sharing on patients with a positive finding on a stool test, the guideline update stated, “This ACS guideline update strongly recommends that follow-up colonoscopy should be regarded as a part of the continuum of the screening process rather than a diagnostic procedure.”6
In the 2022 update of the Frequently Asked Questions (FAQs), the Departments of Labor, Health and Human Services (HHS) and the Treasury (Tri-Departments) cited the 2021 final colorectal cancer recommendation statement from the USPSTF, which stated, “When stool-based tests reveal abnormal results, follow-up with colonoscopy is needed for further evaluation….Positive results on stool-based screening tests require follow-up with colonoscopy for the screening benefits to be achieved.” The USPSTF also noted that their recommendation also applied to direct visualization tests, i.e., flexible sigmoidoscopy and computed tomography colonography (CTC), which also require follow up with colonoscopy in the event of abnormal findings. The FAQ quoted from the USPSTF’s supporting evidence section of the recommendation statement, “In addition, in the Supporting Evidence section of the Recommendation Statement, “Several comments requested that colonoscopy to follow up an abnormal noncolonoscopy screening test result be considered part of screening [emphasis added]. The USPSTF recognizes that the benefits of screening can only be fully achieved when follow-up of abnormal screening test results is performed.” In response, the Tri-Departments stated in the FAQ, “A plan or issuer must cover and may not impose cost sharing with respect to a colonoscopy conducted after a positive non-invasive stool-based screening test or direct visualization screening test for colorectal cancer for individuals described in the USPSTF recommendation……in accordance with the requirements of PHS Act section 2713 and its implementing regulations.”1
Why is this important? There are three overarching reasons. First, it is well established that even small out-of-pocket costs are a barrier to receiving recommended essential health care,7 and, in contrast, removing cost barriers results in increased uptake of essential care, especially in low-income populations.8 Although the concept of cost-sharing was intended to be a brake on nonessential care, it has turned out to be indiscriminate, i.e., reducing the quantity of both nonessential and essential care, including preventive care excluded from patient cost-sharing.9, 10. Wharam and colleagues showed that women in high-deductible plans with significant cost-sharing experienced considerable delays in breast cancer diagnostic testing and treatment, and although these delays were longer in lower vs. higher income women, they were evident in both income groups.11 Second, not attending regular screening, or failure to receive timely follow up testing is associated with cancer progression and premature mortality,12, 13 and with worse outcomes due to missed opportunities to detect and treat cancer early in marginalized populations.14-16 Third, patient cost-sharing associated with screening, diagnosis, and subsequent treatment have increased significantly in the last decade,17-19 and can result in enduring financial hardship.20 In the case of colorectal cancer screening, studies have shown longer delays in follow-up testing among Medicaid patients compared with patients with commercial health plans, but significant proportions of patients in both groups fail to be followed up at all.21 In a study of colorectal cancer mortality in a large health plan, failure to follow-up a positive stool test was associated with a seven-fold greater risk of dying from colorectal cancer compared with adults who were up-to-date with screening. 22 Among commercially insured women, colposcopy, which is recommended for women with positive findings on a cervical cancer screening test is not covered without cost-sharing. In a recent analysis of adherence to recommended follow-up after an abnormal cervical cancer screening exam among women in New Mexico from 2015-2019, Perkins, et al. documented that approximately one-third of women were not properly followed up when both cytology and high risk human Papilloma virus (hrHPV) were abnormal, and more than half of women did not receive follow-up when either test was abnormal.23 In an evaluation of commercial plan data, Fendrick, et al. showed that from 2006-2019, 79% of colposcopy episodes were associated with cost-sharing which was described as “nontrivial,” and increased significantly throughout the study period.18 The pattern of increasing patient cost-sharing has also been observed for additional imaging evaluations and procedures for women who were recalled for further evaluation after a screening mammogram.24 Although lung cancer screening uptake in the U.S. has been low, there already is evidence of disparities in access, cost burdens to follow-up care, considerable patient cost-sharing associated with follow-up examinations, and worse outcomes in marginalized populations. 26, 27
In conclusion, the period of time since the implementation of the ACA has seen significant benefit for reducing the number of uninsured; however, cost barriers to completing the continuum of screening are undermining the desired outcomes of increasing access to cancer screening, i.e., the determination of whether the patient has cancer. It is ironic that the intent of the forward-looking ACA provision to remove cost barriers to cancer screening tests would be compromised by the increasing burden of cost-sharing for recommended follow-up care that is part of the screening continuum when the patient has a much higher probability of having cancer.
There is unwavering agreement that we must endeavor to reduce this burden of cancer, and that reducing that burden is within our reach with existing knowledge. In the recent report of the President’s Cancer Panel, Closing the Gap in Cancer Screening, the Panel stated, “The Panel supports efforts—including legislation—to ensure that cost-sharing for cancer screening or additional surveillance and recommended diagnostic services after an abnormal cancer screening test does not deter patients from receiving these services.”29 Given the evidence that patient cost-sharing, whatever the source, diminishes the timely uptake of essential cancer care associated with the full continuum of screening, it is time that strong polices are put in place to eliminate cost-sharing for recommended cancer screening and follow-up testing through the diagnosis of cancer.
Prepared by: Robert A. Smith, PhD, Sr Vice President, Cancer Screening, Early Cancer Detection Science Department, American Cancer Society, Atlanta, GA. Email: email@example.com. February 26, 2023