Our study explored which FITs were being used by primary care practices across Oregon and what the cost was for the practices to purchase FIT tests. While 87% of the respondents knew the type of FIT in use, only 40% could report on the costs; 32% of those reporting costs received their FITs for free. This lack of cost information is an interesting finding because it raises the possibility that either that the FIT purchasing decision is not made by the primary care practice manager or quality improvement lead, or that the cost of the test is not typically a criteria for FIT selection. Of the practices that did know the cost of their FITs, we found no cost patterns by type of FIT or rurality.
Our analysis, however, identified an interesting relationship between cost and the source of the FIT. If a FIT was supplied by a laboratory or health system, it was more likely to be free of cost to the practices, while FITs procured from a vendor were more likely to have a cost associated with it. Our findings indicate that most practices without lab or health system supplied kits are spending more for their FIT tests. There is a highly statistically significant difference between costs of FITs that are vendor-supplied as opposed to lab- or health plan-supplied FITs. While many practices didn't know the cost, it seems that in general, the labs and health plans are providing FITs for free or low cost while vendors are charging practices a higher rate per FIT.
Responding practices used a wide variety of tests, and only 43% of the practices surveyed were using FIT tests with strong evidence of clinical effectiveness (both high sensitivity and specificity: OC Auto®, OC Light®, and Insure®) in the literature (31). More than 10 different FITs were used across the 84 practices, and 75% of respondents used one of five tests: Hemosure®, OC Auto®, Insure®, Hemoccult-ICT®, and OC-Light® iFOBT. Of the 160 tests approved by FDA, the American Cancer Society recommends only about 10 of them (16) and the USPSTF evidence review identified only OC Auto® and OC Light® as having adequate data demonstrating high sensitivity and specificity (3).
These key findings must be considered within the larger context of clinical provision of CRC screening. Over half our survey respondents were located in rural or frontier regions of Oregon, and the majority had fewer than 10 providers. Rural areas are home to about 60 million people in the US, and Medicaid covers nearly 1 in 4 rural residents under age 65 (24%)(32), but rural and frontier residents have lower rates of cancer screening (33). Differences in the FIT quality and ability to obtain FITs in a cost-effective manner could have far reaching consequences for addressing CRC screening disparities in these small community practices.
Our survey findings might indicate that organizational constraints drive FIT selection more than either cost or test quality. Cost structures can vary greatly depending on who is purchasing FITs, where lab processing occurs, and who receives reimbursement for it, as well as external incentives for screening, such as state or federal incentive metrics. In addition, we found that some practices used 2–3 different FIT types simultaneously; clarifying information from these practices suggest that FIT type depended on insurance coverage or whether the clinic was part of a health plan partnered mailed screening outreach initiative. One feature of interventions to implement FIT outreach programs should likely include working with practices to evaluate if changes are needed in their current FIT, and to advocate for tests that have clinical and patient preferred characteristics (17).
Cost of FIT may impact the willingness of practices to distribute FIT kits through effective strategies like mailed FIT. Mailed FIT programs are known to increase CRC screening rates, in a range of anywhere from 15–28% (34, 35) and they are especially effective at reaching patient groups at higher risk for being unscreened(36, 37). However, the structure of a mailed FIT program (20–22) makes it more susceptible to cost of FIT variations. First, patients generally have a higher chance of completing a FIT given to them by their provider in-person (38, 39) and clinics may have concerns regarding costs associated with distributing FITs that are not completed. If a larger percentage of the FITs mailed to patients might not be processed compared to in-clinic distribution, primary care practices might be more reluctant to purchase and mail FIT kits to the entire population overdue for CRC screening. A small difference in the cost of FIT is magnified in this approach, such that FITs procured at the minimum cost reported here of $0.83 versus the maximum of $6.41 could lead to an almost 8-fold difference ($83 vs $641) if mailed FITs were distributed to 100 patients in a clinic. Second, clinics serving a smaller patient population may be more likely to be impacted by FIT costs when implementing a mail out program. The Center for Disease Control and Prevention (40) found that, in cost data from 124 screening programs, those that screened a larger volume of people achieved a lower cost per person screened than those screening a smaller population and attributed the finding to economies of scale.
By knowing the cost of the FIT tests themselves, primary care practices can better evalutate the return on investment of FIT outreach programs, and also whether investments in activities that increase rates of return would help offset the costs of unreturned FIT tests. A population-based FIT testing approach is even more effective when paired with interventions to decrease barriers to CRC screening, such as patient reminders, patient or provider incentives, education, or FIT mailing programs (25, 41). Our results might make it easier for primary care practices to assess the cost-benefit of implementing these programs to increase rates of FIT returns.
Limitations
Our study does have certain limitations. First, this was a cross-sectional survey of primary care practices within one state and there may be different cost patterns in the non-responding practices. However, our response rate of 33% is similar to prior surveys (42). Second, our findings must be interpreted cautiously because a large number of respondents could not tell us the cost of their FITs, therefore we are not able to do regression analysis by clinical characteristics of the full sample. We cannot determine if the practices with unknown FIT costs have same distribution as known costs. For example, it is possible that the practices who did not know the cost of their FITs were mostly practices who had the FITs provided for free or at a low cost. Third, many of the FITs in use lack evidence of clinical effectiveness; yet they were clearly the preferred test for these clinical sites. Qualitative work, for example, could explore the relationships between practices, vendor, lab, and FIT selection to determine the driving factors as well as to explore why practices may still utilize poorer quality FIT/FOBTs. Finally, purchase of a certain type of FIT does not equate to the full costs of using FIT to screen patients, since it excludes lab processing costs and implemention of any labor or staffing for outreach programs. Our survey data does not let us explore when the purchase of the FITs are offset by lab processing reimbursements of those tests. In other words, there might be broader system-level cost considerations that a health care practice takes into account. Despite these limitations, primary care clinics could use these data to examine return on investment of various CRC screening outreach approaches (cost per test/cost per completed test) and to negotiate for FITs at a better price.