Controlled Substance Lock-In Programs: Examining An Unintended Consequence Of A Prescription Drug Abuse Policy

Abstract

Controlled substance lock-in programs are garnering increased attention from payers and policy makers seeking to combat the epidemic of opioid misuse. These programs require high-risk patients to visit a single prescriber and pharmacy for coverage of controlled substance medication services. Despite high prevalence of the programs in Medicaid, we know little about their effects on patients' behavior and outcomes aside from reducing controlled substance-related claims. Our study was the first rigorous investigation of lock-in programs' effects on out-of-pocket controlled substance prescription fills, which circumvent the programs' restrictions and mitigate their potential public health benefits. We linked claims data and prescription drug monitoring program data for the period 2009-12 for 1,647 enrollees in North Carolina Medicaid's lock-in program and found that enrollment was associated with a roughly fourfold increase in the likelihood and frequency of out-of-pocket controlled substance prescription fills. This finding illuminates weaknesses of lock-in programs and highlights the need for further scrutiny of the appropriate role, optimal design, and potential unintended consequences of the programs as tools to prevent opioid abuse.

Using prescription monitoring program data to characterize out‐of‐pocket payments for opioid prescriptions in a state Medicaid program

“…This may affect the development of programs and policies aimed at reducing high‐risk opioid prescriptions. A recent study of Medicaid recipients in North Carolina found that rates of opioid or benzodiazepine fills lacking a pharmacy claim increased from 16% to 55% following enrollment in the state's lock‐in program, which requires individuals to use the same prescriber and pharmacy for controlled substance prescriptions . This suggests that patients may circumvent utilization management tools aimed at reducing pharmacy shopping by paying cash.…”

“…Out‐of‐pocket payment for prescription opioids is believed to be associated with abuse and diversion, though this is poorly documented. There are few studies examining this behavior because most administrative data from payers or retail pharmacies do not capture out‐of‐pocket payments . Using data submitted directly from retail pharmacies, one study found that opioid pharmacy or prescriber shoppers were significantly more likely to pay out‐of‐pocket for opioids than those who were not opioid shoppers .…”

“…In Washington state, one report found that over 2000 Medicaid beneficiaries had both a Medicaid pharmacy claim of and an out‐of‐pocket paid controlled substance prescription on the same day . Another recent study found that individuals pay out‐of‐pocket for opioids and benzodiazepines to avoid utilization management strategies used by state Medicaid programs …”

“…There are few studies examining this behavior because most administrative data from payers or retail pharmacies do not capture out-of-pocket payments. 5,6 Using data submitted directly from retail pharmacies, one study found that opioid pharmacy or prescriber shoppers were significantly more likely to pay out-of-pocket for opioids than those who were not opioid shoppers. 6 In Washington state, one report found that over 2000 Medicaid beneficiaries had both a Medicaid pharmacy claim of and an out-of-pocket paid controlled substance prescription on the same day.…”

Trajectories of dispensed prescription opioids among beneficiaries enrolled in a Medicaid controlled substance “lock‐in” program

“…As previously described, data included NC Medicaid claims linked to records from the NC Controlled Substance Reporting System (CSRS), NC's Prescription Drug Monitoring Program. Data were deterministically linked for those enrolled in the LIP during the first 2 years of its operation through a Centers for Disease Control and Prevention grant supporting the intensive linkage . NC Medicaid data included beneficiaries' demographic characteristics, periods of Medicaid enrollment, adjudicated pharmacy and medical claims, and assigned LIP enrollment and release dates.…”