The lock-in loophole: Using mixed methods to explain patient circumvention of a Medicaid opioid restriction program.

Lock-in programs are proliferating among private and public payers to restrict access to controlled substance prescriptions and enhance care coordination for patients exhibiting high-risk use of, primarily, opioids. Patients enrolled in lock-in programs are required to seek opioids from a designated provider and pharmacy for insurance coverage of their opioid and benzodiazepine prescriptions. Lock-in program restrictions are often circumvented by patients through out-of-pocket cash purchases of opioid prescriptions, undermining the program's intended function. This study sought to construct and explain trajectories of Medicaid-covered and cash pay opioid prescription fills among adults enrolled in an opioid lock-in program. : We used sequential explanatory mixed methods, which involved a quantitative retrospective cohort analysis of opioid fill trajectories using North Carolina Medicaid administrative claims data linked with state prescription drug monitoring program data, followed by qualitative semi-structured interviews with North Carolina pharmacists. The quantitative component included adults enrolled in the North Carolina Medicaid lock-in program between 10/1/2010-3/31/2012. The qualitative component included a maximum variation sample of community pharmacists in North Carolina delivering care to lock-in patients. Quantitative outcomes included group-based trajectories of monthly Medicaid-covered and cash pay opioid prescription fills six months before and after LIP enrollment, and qualitative analyses generated themes explaining observed trajectories. : Two-thirds of subjects exhibited reduced Medicaid-covered opioid prescription fills and no increase in cash pay fills after lock-in enrollment, with one-third exhibiting increased cash pay fills after lock-in. Pharmacists attributed increases in cash pay fills primarily to illicit behaviors, while some cash pay behavior likely reflected new unintended barriers to care. : Lock-in programs appear to reduce prescription opioid use for most enrolled patients. However, lock-in programs may have limited capacity to deter illicit behaviors among patients intent on abusing, misusing, or diverting these medications and may introduce new access barriers to necessary care for some.