Improving Access to Point of Care Testing through Sound Science & Regulatory Reform

The Value Proposition of CLIA-Waived POCT in Rural Communities

Nearly 25% of the U.S. population,[1] including 36% of veterans in the Dept. of Veterans Affairs system,[2] live in rural areas. Also, rural areas have a higher percentage of seniors and persons in fair/poor health than urban areas, making access to care crucial. However, the distances between patient and provider in rural areas,[3] and the potentially limited availability of transportation options, can create significant barriers to medical access in rural communities. For example

  • A study of 12 rural counties in Appalachian North Carolina showed that individuals with a driver's license had 2.29 times more health care visits for chronic care and 1.92 times more visits for regular checkup care than those who did not. Further, those persons who had family or friends who could provide transportation had 1.58 times more visits for chronic care than those who did not.[4]
  • A study of veterans living with HIV showed that those living with HIV were more likely to rely on primary care as opposed to specialty care as distances to infectious disease specialists increased. As travel time to ID care increased from less than 15 minutes to over 90 minutes, use of ID care decreased from 88% to 71% (P < .01), while use of primary care increased from 68% to 86% (P < .0001).[5]
  • In a U.S. Department of Veterans Affairs Office of Rural Health survey, patients, providers, and staff, distance to healthcare providers was considered the most important barrier for rural veterans seeking healthcare. In-depth interviews revealed specific examples of barriers to care such as long travel for common diagnostic services, routine specialty care, and emergency services. Providers and staff reported challenges to healthcare delivery due to distance.[6]
  • In a study of diabetes patients in rural Pennsylvania, those residing more than 10 miles from the diabetes management center [odds ratio (OR) = 1.91, p < .0001], being younger (OR = 0.99, p = .00015), and having a longer duration of diabetes (OR = 1.03, p = .0007) were significant contributors to a A1C >7% adjusted for individual- and community-level factors. In addition, those who lived within 10 miles of their center were 2.5 times more likely to have improved their A1C values between their first and last office visit.[7]

Another barrier to medical care is a shortage of medical personnel in rural areas. Only 10% of physicians in the U.S. practice in rural areas (to serve the 25% of Americans living in those areas), and the per capita number of specialists practicing in rural areas is less than one-third of those practicing in urban areas.[8] This leaves much of healthcare in the hands of Rural Health Clinics, physician offices, and similar healthcare provider venues – the kinds of venues that offer point-of-care testing with CLIA waived tests.

In this environment, the need for an additional visit to a healthcare provider presents yet another obstacle that patients must overcome to get the care they need. Delaying diagnostic and treatment decisions to the next scheduled visit creates another opportunity for that patient to be lost-to-follow-up or not otherwise receive the care they need in a timely fashion. Thus, it’s important to make the most of each physician office or clinic visit. Offering expanded, safe & effective CLIA-waived testing options gets more diagnostic information into the hands of a healthcare providers when the patient is in the exam room, increasing the chances that a diagnosis can be made, and treatment can begin, at the first visit.