Fentanyl CLIA Waived Status: A Life-Saving FDA Fix

Some policy changes for help improve access to life-saving, affordable, evidence-based outpatient addictions care are complex. Some are simple.

One super simple fix the FDA could take to increase Fentanyl Screening Access for SUD Care — make Fentanyl tests CLIA waived.

Why Do it?

• Deaths involving fentanyl caused over 30,000 deaths in 2018.

• ⅔ of Opioid-involved deaths involved synthetic opioids, most fentanyl.

• States like Massachusetts have identified it as a key need to promote public health and safety.

• Many substance use disorder clinics and treatment providers have CLIA-waived labs on-site. As CLIA-waived labs, they are restricted to only use FDA-approved CLIA-waived tests and screens or risk loss of their CLIA waiver. Without a CLIA waiver, treatment providers cannot perform necessary clinical screens (i.e. urine drug screens, pregnancy tests).

• The current CLIA-waived urine drug screen options in the marketplace all include opioid screening, but none include fentanyl screening due to FDA rules.

• In order to screen for fentanyl legally, clinics have to send the urine to an external lab for analysis. This creates a time gap in care response, restricting access to life-saving treatment. This also adds a significant additional cost.

• Currently, a significant proportion of outpatient substance use treatment costs are unnecessarily spent in unnecessary external laboratory analysis. However, until fentanyl is CLIA-waived, providers will have to keep partnering with external labs. Issues with this have been noted by the Office of Inspector General with $66.3 million in improper payments and Kaiser Health News. 

Having performed thousands of urine drug screens in my career and having oversight of a CLIA-waiver program for a multi-state behavioral health provider, I am unaware of the FDA justification for not approving Fentanyl testing as a CLIA-waived lab.

Reasons I believe Fentanyl Meets CLIA Waived test Requirements:

Simplicity: CLIA- waived test must test in a way that is simple and makes the likelihood of erroneous results negligible. Fentanyl tests meet this requirement. The tests work exactly like other urine drug screens, pregnancy tests, and other CLIA-waived substance tests.

Specimen Type: CLIA-waived tests must use Unprocessed specimens (whole blood, urine, oral fluid). I promise you that no centrifuge is required! Fentanyl screen meets this requirement, using unprocessed urine samples.

Accuracy: Test must be accurate and reliable. Commercially available point of care fentanyl tests are at 98% accuracy, higher than other CLIA-waived urine drug tests (some of which of 97 or 97% accurate).

Risk: Must pose no reasonable risk of harm to the patient if the test is performed incorrectly. Meets. Fentanyl testing is safe, involves no finger pricks, and can be done with the same sample provided to test other substances.

Cleared by FDA for home use. Does not Meet. FDA’s list of waived analytes does not include Fentanyl.