POC Testing: More FDA Approved Tests Than Ever, But Will Labs Be Reimbursed?
Revenue cycle management leaders provide their thoughts on how lab leaders may want to proceed when it comes to POC tests

Recently, there have been more point-of-care (POC) and rapid tests approved by regulatory agencies like the U.S. Food and Drug Administration (FDA), but experts have raised concerns about obtaining reimbursement for them.1 Revenue cycle management leaders for clinical laboratories weigh in with their thoughts on the issue, and how lab leaders may want to proceed when it comes to POC tests.
What are POC tests and when are they reimbursed by insurance?
POC tests provide rapid results and can be performed near the patient—at the point of care. Following the COVID-19 pandemic, public awareness of POC tests has significantly increased. Most individuals in the US have since experienced taking an at-home test sometime during the last five years and/or administering one to a family member, for example.
Other familiar POC tests include, but are not limited to, pregnancy, blood glucose, hemoglobin A1C, urine drug screening, and rapid strep tests. Most often, these tests are completed using portable instruments or test kits, and for those not available over the counter (OTC), testing can be done at the bedside by a nurse or in a doctor’s office by a physician. According to Advisory Board, a company that supports healthcare industry leaders, POC testing allows for “prompt and appropriate treatment decisions.” Such decisions lead to better health outcomes when quick treatment plans must be implemented given the potential prognosis with no intervention.2
The challenge for consumers, according to Ann Lambrix, vice president of Payors and Revenues Management at GoPath Diagnostics, is that some POC tests can be bundled into a physician visit but are not covered if purchased OTC. Examples of such tests include pregnancy, rapid COVID-19, and strep tests. If consumers buy such tests over the counter and then submit a claim to obtain reimbursement from their health plan, most would not receive said reimbursement, although that depends on their particular coverage.
Lambrix believes the reason for the disparity in insurance coverage is that there is no physician or healthcare provider managing the results when a consumer purchases and utilizes an OTC POC test.
“We live in a country where insurance plans dictate the rules of coverage and put the medical necessity of the test in the hands of the healthcare provider,” she explains. These same POC tests would likely be reimbursed by insurance if a healthcare provider ordered the tests during a patient encounter where signs and symptoms were present. In that instance, medical necessity for the test is proven by the provider prior to administration of the test, and the provider is available to read and deliver the results so that appropriate treatment planning with the patient can occur.
POC test accuracy and administration
Tami Shaw, lab revenue cycle management consultant, notes that POC testing is not as accurate or reliable as running a test to measure the same thing via validated instrumentation in a laboratory. This is illustrated in a study published in 2023 that investigated the performance of two POC tests for COVID-19, which showed an 84 and 76.5 percent sensitivity and 98.5 and 98.8 percent specificity, respectively, in successfully identifying infection with the SARS-CoV-2 virus that causes COVID-19.3 On the other hand, reverse transcription polymerase chain reaction (RT-PCR), a test performed on validated instrumentation in a laboratory and which is not currently available via portable test kits, was determined to have a 92.7 percent sensitivity, according to a 2022 publication. That study emphasized that RT-PCR is the “gold standard for detecting recent infection” and highlighted that the specificity of RT-PCR is estimated to be close to 100 percent.4 Thus, while POC testing has its place, it also has limitations.
Patients can receive POC testing at a doctor’s office, which may also have an on-site laboratory. However, the POC test would be performed by the nurse or doctor during patient care, according to Shaw, and not necessarily delivered to the lab for resulting or interpretation. As a result, Shaw says it would be “very unusual” for laboratories themselves to conduct POC testing, particularly independent reference labs, which are not usually located at the same site where the patient interaction and treatment takes place. Shaw predicts that, should an independent lab attempt to bill for POC testing, they would likely receive an automatic denial and would need to make a compelling appeal for the medical necessity to have a chance at receiving reimbursement.
Director of revenue cycle management operations at Lighthouse Lab Services Dyana Williams reports that she has never experienced laboratories attempting to bill for POC tests when they are not physically at the site of care. She says she hasn’t been involved in any conversations that support changing how POC tests are currently performed, billed, or reimbursed or heard of any attempts at increasing the coverage to allow laboratories to be reimbursed for said testing.
Should labs offer POC tests given the reimbursement hurdles?
Given this reported lack of movement on allowing reimbursement for POC tests conducted by laboratories, it’s unlikely that labs can expect to regularly obtain reimbursement for completing said tests in the foreseeable future. One exception may be laboratories located at the site of patient care. Even then, it is typically a nurse or physician conducting the POC testing and resulting for the patient, which does not usually occur inside the laboratory. As such, it is not likely a good business decision for labs to attempt to offer POC testing if they are financially reliant on reimbursement of these services. These tests can inform additional testing that may need to be performed, which could be completed by the laboratory and would likely be reimbursed. However, in the current regulatory landscape, said testing would likely need to be ordered by a physician, which would require a patient visit, during which a provider could perform that POC testing themselves.
Reimbursement is a complicated issue that varies widely based on individual health plans and insurance providers. Laboratories forecasting their finances would do themselves a favor to research and understand all aspects of reimbursement ahead of launching new testing to avoid a situation where reimbursement is unlikely to be obtained, as seems to be the case with POC tests.
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