Outcomes and Costs in Patients with Immune Thrombotic Thrombocytopenic Purpura Receiving Front-Line Versus Delayed Caplacizumab: A US Hospital Database Study.

European real-world data indicate that front-line treatment with caplacizumab is associated with improved clinical outcomes compared with delayed caplacizumab treatment. The objective of the study was to describe the characteristics, treatment patterns, and outcomes in hospitalized patients with an immune-mediated thrombotic thrombocytopenic purpura (iTTP) episode treated with front-line versus delayed caplacizumab in the US. This retrospective cohort analysis of a US hospital database included adult patients (≥18 years) with an acute iTTP episode (a diagnosis of thrombotic microangiopathy and ≥1 therapeutic plasma exchange [TPE] procedure) from January 21, 2019, to February 28, 2021. Unadjusted baseline characteristics, treatment patterns, healthcare resource utilization, and costs were compared between patients who received front-line versus delayed (<2 vs ≥2 days after TPE initiation) caplacizumab treatment. Out of 39 patients, 16 (41.0%) received front-line and 23 (59.0%) received delayed treatment with caplacizumab. Baseline characteristics and symptoms were similar between the two groups. Patients who received front-line caplacizumab treatment had significantly fewer TPE administrations (median: 5.0 vs 12.0); and a significantly shorter hospital stay (median: 9.0 days vs 16.0 days) than patients receiving delayed caplacizumab therapy. Both of these were significantly lower in comparison of means (t-test P < .01). Median inpatient costs (inclusive of caplacizumab costs) were 54% higher in the delayed treated patients than in the front-line treated patients (median: $112 711 vs $73 318). TPE-specific cost was lower in the front-line treated cohort (median: $6 989 vs $10 917). In conclusion, front-line treatment with caplacizumab had shorter hospitalizations, lower healthcare resource utilization, and lower costs than delayed caplacizumab treatment after TPE therapy.

Buprenorphine Out-of-Pocket Costs and Discontinuation in Privately Insured Adults With Opioid Use Disorder.

This cohort study examined the association between out-of-pocket costs for an initial buprenorphine prescription and its discontinuation among commercially insured US adults with opioid use disorder.

Many Medicare Beneficiaries Do Not Fill High-Price Specialty Drug Prescriptions.

For high-price drugs, Medicare Part D beneficiaries who do not receive a low-income subsidy must pay a percentage of the drug's price for each medication fill. Without that subsidy, which lowers out-of-pocket spending, beneficiaries typically pay hundreds or thousands of dollars for a single fill. We estimated the proportion of Part D beneficiaries in fee-for-service Medicare, with and without a subsidy, who do not initiate treatment (that is, do not fill a new prescription) with high-price Part D drugs newly prescribed for four conditions. Examining 17,076 new prescriptions issued between 2012 and 2018 for Part D beneficiaries from eleven geographically diverse health systems, we found that beneficiaries receiving subsidies were nearly twice as likely to obtain the prescribed drug within ninety days as those without subsidies. Among beneficiaries without subsidies, we observed noninitiation for 30 percent of prescriptions written for anticancer drugs, 22 percent for hepatitis C treatments, and more than 50 percent for disease-modifying therapies for either immune system disorders or hypercholesterolemia. Our findings support current legislative efforts to increase the accessibility of high-price medications by reducing out-of-pocket expenses under Medicare Part D, particularly for beneficiaries without low-income subsidies.

Geographic differences in community oncology provider and practice location characteristics in the central United States.

PURPOSE: How care delivery influences urban-rural disparities in cancer outcomes is unclear. We sought to understand community oncologists' practice settings to inform cancer care delivery interventions. METHODS: We conducted secondary analysis of a national dataset of providers billing Medicare from June 1, 2019 to May 31, 2020 in 13 states in the central United States. We used Kruskal-Wallis rank and Fisher's exact tests to compare physician characteristics and practice settings among rural and urban community oncologists. FINDINGS: We identified 1,963 oncologists practicing in 1,492 community locations; 67.5% practiced in exclusively urban locations, 11.3% in exclusively rural locations, and 21.1% in both rural and urban locations. Rural-only, urban-only, and urban-rural spanning oncologists practice in an average of 1.6, 2.4, and 5.1 different locations, respectively. A higher proportion of rural community sites were solo practices (11.7% vs 4.0%, P<.001) or single specialty practices (16.4% vs 9.4%, P<.001); and had less diversity in training environments (86.5% vs 67.8% with <2 medical schools represented, P<.001) than urban community sites. Rural multispecialty group sites were less likely to include other cancer specialists. CONCLUSIONS: We identified 2 potentially distinct styles of care delivery in rural communities, which may require distinct interventions: (1) innovation-isolated rural oncologists, who are more likely to be solo providers, provide care at few locations, and practice with doctors with similar training experiences; and (2) urban-rural spanning oncologists who provide care at a high number of locations and have potential to spread innovation, but may face high complexity and limited opportunity for care standardization.

Impacts of a Medicaid "lock-in" program on opioid use disorder treatment and services and naloxone dispensing.

BACKGROUND: "Lock-in" programs are used by health insurers to reduce the risk of adverse outcomes that can result from overutilization of opioids and other controlled substances. We estimated the association between North Carolina's Medicaid lock-in program and use of opioid use disorder treatment-related services and naloxone dispensing. METHODS: A cohort study of individuals who became eligible for a Medicaid lock-in program between December 2016 and December 2019 (n = 21,220). We compared those enrolled in the program to those eligible but not enrolled. Outcomes included rate of medication for opioid use disorder (MOUD); rate of other substance use disorder treatment (e.g., detoxification); and naloxone dispensing. RESULTS: The majority of beneficiaries enrolled in the program had recently received MOUD or other treatment prior to enrollment (59%). After controlling for several potential confounders, the program was associated with slight increases in MOUD use, compared to those eligible but not enrolled (adjusted rate ratio: 1.09, 95% CI: 1.04,1.14). Those enrolled in the program received, on average, 5.4 more days of MOUD per person per year than those eligible but not enrolled (adjusted risk difference: 5.43, 95% CI: 2.49,8.36). Naloxone dispensing was similar and low among those enrolled and not enrolled in the program (7-8%). CONCLUSIONS: Enrollment in a Medicaid lock-in program was associated with a small increase in the number of days with substance use disorder treatment. However, given the high prevalence of opioid use disorder among beneficiaries in the program, findings highlighted considerable opportunity for improvement in treatment utilization and retention and a need for increased naloxone dispensing.

Health costs of women with chronic overlapping pain conditions by opioid and complementary and integrative health use.

OBJECTIVE: To estimate differences in average annual health care expenditures of adult women with chronic overlapping pain conditions (COPCs) by pain treatment modality as follows: (1) no long-term opioid or complementary and integrative health (CIH) use; (2) CIH only use; (3) long-term opioid only use; and (4) long-term opioid and CIH use. DATA SOURCE: Cross-sectional Medical Expenditure Panel Survey data (2012-2016). STUDY DESIGN: We estimated differences between average annual expenditures of adult women with COPCs by their use of long-term opioids and CIH modalities. Generalized linear regression with a log link function was used to estimate adjusted marginal effects in annual expenditures. The distribution family was chosen based on Modified Park Tests. We controlled for pain severity, patient demographic characteristics, physical limitations, comorbidities, mental health, insurance status, physical therapy use, and census region. We also employed propensity-score based marginal mean weighting through stratification to balance our treatment groups on observed covariates. DATA COLLECTION/EXTRACTION METHODS: We identified adult women (>17 years) with one or more self-reported COPC using 3-digit International Classification of Diseases (ICD)-9/10-Clinical Modification (CM) codes (N = 9169) and categorized their use of CIH and long-term opioids. PRINCIPAL FINDINGS: Compared to women without long-term opioid or CIH use, CIH only use was significantly associated with lower inpatient expenditures (-$947 [-$1699, -$196]; p-value < 0.01), higher office-based expenditures ($1345 [$944, $1746]; p-value < 0.001), and higher patient out-of-pocket expenditures ($628 [$409, $848]; p-value < 0.001). Long-term opioid use, alone or in combination with CIH, was significantly associated with higher expenditures (p-value < 0.05) in total and across all utilization categories compared to women without any long-term opioid or CIH use. CONCLUSIONS: Our results indicate that CIH treatment approaches for chronic pain have the potential to be utilized without increasing overall costs. Future research should further examine the role of CIH modalities in achieving cost-effective pain management that reduces avoidable opioid use.

Trends in Medicare Part D coverage of generics with equivalent brand-name drugs.

OBJECTIVES: To evaluate whether increased placement of generic drugs on higher cost-sharing tiers in Medicare Part D is associated with coverage of multisource brand-name drugs, plan type, or product characteristics. STUDY DESIGN: Descriptive study of Medicare Prescription Drug Formulary Files. METHODS: We analyzed plan coverage and tiering of brand-name drugs and matched generics from 2013-2019. We compared tiering changes and estimated out-of-pocket spending by tier for all Part D plans and by plan type (Medicare Advantage prescription drug [MA-PD] vs stand-alone prescription drug plan [PDP]) for covered generic drugs. Finally, we identified the generic products commonly placed on higher tiers in 2019 and categorized them based on clinical characteristics. RESULTS: Across 5,220,488 plan-product combinations in 2019, 76.4% of generic drug observations reflected coverage on Part D plan formularies, compared with only 12.1% of brand-name drugs. Between 2013 and 2019, the share of observations reflecting covered generics on lower tiers decreased from 76.8% to 53.9%, whereas the share on higher tiers increased from 7.5% to 28.0%. MA-PD plans were more likely than PDPs to place generic drugs on lower tiers, even among plan sponsors offering both plan types. Despite these trends, higher tier placement does not appear to be related to more generous coverage of brand-name products. Instead, in 2019, 70% of high-tier generics had multiple formulations, required heightened clinical monitoring, or had head-to-head treatment options available. CONCLUSIONS: Although Part D plans have increasingly placed covered generic drugs on higher formulary tiers over time, this may be partly explained by a drug's clinical profile and availability of substitutes rather than preferred brand-name drug coverage.

Medicaid prescription limits and their implications for naloxone accessibility.

BACKGROUND: Expanding access to and utilization of naloxone is a vitally important harm reduction strategy for preventing opioid overdose deaths, particularly in vulnerable populations like Medicaid beneficiaries. The objective of this study was to characterize the landscape of monthly prescription fill limit policies in Medicaid programs and their potential implications for expanding naloxone use for opioid overdose harm reduction. METHODS: A cross-sectional, multi-modal online and telephonic data collection strategy was used to identify and describe the presence and characteristics of monthly prescription fill limit policies across state Medicaid programs. Contextual characteristics were described regarding each state's Medicaid enrollment, opioid prescribing rates, and overdose death rates. Data collection and analysis occurred between February and May 2020. RESULTS: Medicaid-covered naloxone fills are currently subject to monthly prescription fill limit policies in 10 state Medicaid programs, which cover 20 % of the Medicaid population nationwide. Seven of these programs are located in states ranking in the top 10 highest per-capita opioid prescribing rates in the country. However, 8 of these programs are located in states with opioid overdose death rates below the national average. CONCLUSIONS: Medicaid beneficiaries at high risk of opioid overdose living in states with monthly prescription fill limits may experience significant barriers to obtaining naloxone. Exempting naloxone from Medicaid prescription limit restrictions may help spur broader adoption of naloxone for opioid overdose mortality prevention, especially in states with high opioid prescribing rates. Achieving unfettered naloxone coverage in Medicaid is critical as opioid overdoses and Medicaid enrollment increase amid the COVID-19 pandemic.

Opioid Use Disorder and Overdose in Older Adults With Breast, Colorectal, or Prostate Cancer.

BACKGROUND: Despite high rates of opioid therapy, evidence about the risk of preventable opioid harms among cancer survivors is underdeveloped. Our objective was to estimate the odds of opioid use disorder (OUD) and overdose following breast, colorectal, or prostate cancer diagnosis among Medicare beneficiaries. METHODS: We conducted a retrospective cohort study using 2007-2014 Surveillance, Epidemiology, and End Results-Medicare data for cancer survivors with a first cancer diagnosis of stage 0-III breast, colorectal, or prostate cancer at age 66-89 years between 2008 and 2013. Cancer survivors were matched to up to 2 noncancer controls on age, sex, and Surveillance, Epidemiology, and End Results region. Using Firth logistic regression, we estimated adjusted 1-year odds of OUD or nonfatal opioid overdose associated with a cancer diagnosis. We also estimated adjusted odds of OUD and overdose separately and by cancer stage, prior opioid use, and follow-up time. RESULTS: Among 69 889 cancer survivors and 125 007 controls, the unadjusted rates of OUD or nonfatal overdose were 25.2, 27.1, 38.9, and 12.4 events per 10 000 patients in the noncancer, breast, colorectal, and prostate samples, respectively. There was no association between cancer and OUD. Colorectal survivors had 2.3 times higher odds of opioid overdose compared with matched controls (adjusted odds ratio = 2.33, 95% confidence interval = 1.49 to 3.67). Additionally, overdose risk was greater in those with more advanced disease, no prior opioid use, and preexisting mental health conditions. CONCLUSIONS: Opioid overdose was a rare, but statistically significant, outcome following stage II-III colorectal cancer diagnosis, particularly among previously opioid-naïve patients. These patients may require heightened screening and intervention to prevent inadvertent adverse opioid harms.

Association of Current Opioid Use With Serious Adverse Events Among Older Adult Survivors of Breast Cancer.

Importance: National efforts to improve safe opioid prescribing focus on preventing misuse, overdose, and opioid use disorder. This approach overlooks opportunities to better prevent other serious opioid-related harms in complex populations, such as older adult survivors of cancer. Little is known about the rates and risk factors for comprehensive opioid-related harms in this population. Objective: To determine rates of multiple opioid-related adverse drug events among older adults who survived breast cancer and estimate the risk of these events associated with opioid use in the year after completing cancer treatment. Design, Setting, and Participants: This retrospective cohort study used 2007 to 2016 Surveillance, Epidemiology and End Results-Medicare data from fee-for-service Medicare beneficiaries with first cancer diagnosis of stage 0 to III breast cancer at age 66 to 90 years from January 1, 2008, through December 31, 2015, who completed active breast cancer treatment. Data were analyzed from October 31, 2019, to June 10, 2020. Exposures: Repeated daily measure indicating possession of any prescription opioid supply in Medicare Part D prescription claims. Main Outcomes and Measures: Adjusted risk ratios (aRRs), estimated using modified Poisson generalized estimating equation models, for adverse drug events related to substance misuse (ie, diagnosed opioid abuse, dependence, or poisoning), other adverse drug events associated with opioid use (ie, gastrointestinal events, infections, falls and fractures, or cardiovascular events), and all-cause hospitalization associated with opioid supply the prior day, controlling for patient characteristics. Results: Among 38 310 women included in the study (mean [SD] age, 74.3 [6.3] years), there were 0.010 (95% CI, 0.008-0.011) adverse drug events related to substance misuse per 1000 person-days, 0.237 (95% CI, 0.229-0.245) other adverse drug events associated with opioid use per 1000 person-days, and 0.675 (95% CI, 0.662-0.689) all-cause hospitalizations per 1000 person-days. Opioid use was associated with increased risk of adverse drug events related to substance misuse (aRR, 14.62; 95% CI, 9.69-22.05; P < .001), other adverse drug events related to opioid use (aRR, 2.50; 95% CI, 2.11-2.96; P < .001), and all-cause hospitalization (aRR, 2.77; 95% CI, 2.55-3.02; P < .001). In a dose-response effect, individuals with high daily opioid doses had consistently higher risks of all study outcomes compared with individuals who had low opioid doses. Compared with days with no opioid exposure, the risk of any adverse drug event related to substance misuse was 3.4-fold higher for individuals with a current opioid supply ≥50 mg morphine equivalent dose per day (aRR, 3.40; 95% CI, 2.47-4.68; P < .001), while the risk was 2.3-fold higher for individuals with 1 to 49 mg morphine equivalent dose per day (aRR, 2.29; 95% CI, 1.89-2.77; P < .001). Conclusions and Relevance: These findings suggest that among older adults who survived breast cancer, continued prescription opioid use in the year after completing active cancer treatment was associated with an immediate increased risk of a broad range of serious adverse drug events related to substance misuse and other adverse drug events associated with opioid use. Clinicians should consider the comprehensive risks of managing cancer pain with long-term opioid therapy.

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

BACKGROUND: 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. Methods: 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. Results: 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. Conclusions: 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.

New-onset persistent opioid use following breast cancer treatment in older adult women.

BACKGROUND: Patients with cancer-related pain are underrepresented in the opioid literature despite high opioid exposure and numerous risk factors for adverse opioid outcomes, including unnecessary persistent opioid use. The objective of this study was to determine the extent, historical trends, and predictors of new-onset persistent opioid use among older adult women after active breast cancer treatment. METHODS: Using Surveillance, Epidemiology, and End Results-Medicare data for opioid-naive women diagnosed with stage 0 to III breast cancer at the age of 66 to 90 years between 2008 and 2013, this study estimated overall and quarterly adjusted probabilities of new-onset persistent opioid use, which was defined as receiving ≥90 days' supply of opioids in the year after active breast cancer treatment. Sensitivity analyses were conducted with an alternative definition of persistent opioid use: any opioid fill 90 to 180 days after active cancer treatment. RESULTS: Nearly two-thirds of the subjects received prescription opioid therapy during cancer treatment. Quarterly probabilities of new-onset persistent opioid use after active treatment ranged from 2% to 4%; in sensitivity analyses, the alternative outcome definition resulted in predicted probabilities ranging from 11.4% to 14.7%. Subjects with more advanced disease, a higher comorbidity burden, a low-income status, and greater opioid exposure during active cancer treatment were more likely to develop persistent opioid use. CONCLUSIONS: Persistent opioid use was an infrequent occurrence among older adult patients with breast cancer completing cancer treatment between 2008 and 2013. This finding was encouraging because of the concerning opioid trends seen in noncancer populations. However, opportunities to further mitigate unsafe opioid use as a complication of cancer care, including standardization of persistent opioid use definitions, should be explored.

Characteristics of New Opioid Use Among Medicare Beneficiaries: Identifying High-Risk Patterns.

BACKGROUND: Opioid prescription patterns, including long-term use, multiple prescribers, and high opioid doses, increase the risk for adverse outcomes; however, previous research in older adult populations has primarily described opioid dose patterns using average daily dose measures or using very high thresholds (i.e., > 100 morphine milligram equivalents [MME] per day). OBJECTIVE: To describe prescription patterns by peak dose among older adults who have newly initiated opioid use in 2014 and describe long-term opioid use and the use of multiple pharmacies and prescribers among those with peak opioid doses over 50 and over 90 MME per day. METHODS: This was a retrospective cohort study of Medicare Part D prescription claims data (5% sample) for beneficiaries aged 65 years and older who were prescribed ≥ 1 opioid prescription in 2014 and did not have an opioid prescription in the preceding 180 days. Within a 1-year period of follow-up, we used prescription claims to characterize individuals' opioid exposure, measuring long-term opioid use (≥ 90 days of continuous opioid supply), unique opioid prescribers, and unique opioid-dispensing pharmacies. Peak MME was defined as the maximum daily MME received across all overlapping opioid prescriptions in the observation period. RESULTS: 144,127 beneficiaries without an opioid prescription in the previous 6 months filled ≥ 1 opioid prescription in 2014. During the 1-year follow-up period, 6.5% of beneficiaries transitioned to long-term opioid use; 39.5% received opioid prescriptions from > 1 prescriber; 18.1% filled opioid prescriptions from > 1 pharmacy; and 21.8% had a peak MME of 50-89. Among the 28.1% of beneficiaries exposed to a peak MME > 50, 8.6% developed long-term opioid use; 7.0% had 3 or more opioid dispensing pharmacies; and 28.0% had 3 or more opioid prescribers. Among the 6.2% of beneficiaries exposed to a peak MME ≥ 90, 18.5% developed long-term opioid use; 13.0% had 3 or more opioid dispensing pharmacies; and 39.6% had 3 or more opioid prescribers. CONCLUSIONS: High doses of opioids were prescribed for about one quarter (28%) of Medicare beneficiaries with new opioid use in 2014. Having multiple opioid prescribers or multiple opioid dispensing pharmacies was common, especially among those prescribed higher doses. These prescription patterns can be particularly helpful to identify older adults with increased opioid-related risk. DISCLOSURES: No funding supported this study. Raman reports research grants from GlaxoSmithKline not related to this study. Roberts was supported by a CTSA grant from NCATS awarded to the University of Kansas Medical Center for Frontiers: The Heartland Institute for Clinical and Translational Research (#KL2TR000119). The other authors have no potential conflicts to report.

Evaluation of a Medicaid Lock-in Program: Increased Use of Opioid Use Disorder Treatment but No Impact on Opioid Overdose Risk.

BACKGROUND: "Lock-in" programs (LIPs) identify beneficiaries demonstrating potential overutilization of opioids, and other controlled substances, and restrict their access to these medications. LIPs are expanding to address the opioid crisis and could be an effective tool for connecting people to opioid use disorder treatment. We examined the immediate and sustained effects of a Medicaid LIP on overdose risk and use of medication-assisted treatment (MAT) for opioid use disorder. METHODS: We analyzed North Carolina Medicaid claims from July 2009 through June 2013. We estimated daily risk differences and ratios of MAT use and overdose during lock-in and following release from the program, compared with periods before program enrollment. RESULTS: The daily probability of MAT use during lock-in and following release was greater, when compared with a period just before LIP enrollment [daily risk ratios: 1.50, 95% confidence interval (CI): 1.18-1.91; 2.27, 95% CI: 1.07-4.80; respectively]. Beneficiaries' average overdose risk while enrolled in the program and following release was similar to their risk just before enrollment (daily risk ratios: 1.01, 95% CI: 0.79-1.28; 1.12, 95% CI: 0.82-1.54; respectively). DISCUSSION: North Carolina's Medicaid LIP was associated with increased use of MAT during enrollment, and this increase was sustained in the year following release from the program. However, we did not observe parallel reductions in overdose risk during lock-in and following release. Identifying facilitators of MAT access and use among this population, as well as potential barriers to overdose reduction are important next steps to ensuring effective LIP design.

Buprenorphine Use and Spending for Opioid Use Disorder Treatment: Trends From 2003 to 2015.

OBJECTIVE: This study examined buprenorphine prescription uptake and expenditure trends among privately insured adults from 2003 to 2015 to inform efforts to expand opioid use disorder treatment. METHODS: A study with a repeated cross-sectional design using MarketScan prescription claims data was conducted to describe trends in total and new buprenorphine use and median total, plan, and out-of-pocket expenditures for a 30-day buprenorphine prescription among privately insured adults from 2003 to 2015. RESULTS: New and total buprenorphine users increased dramatically from 2003 to 2013 and plateaued. Total buprenorphine spending was stable from 2003 to 2008, increased from 2009 to 2013, and declined from 2013 to 2015. Out-of-pocket expenditures steadily decreased from $67 in 2003 to $32 in 2015 for a 30-day prescription. CONCLUSIONS: Buprenorphine treatment costs were stable for health plans and declined for privately insured adults since 2003. Identifying remaining barriers to addressing the opioid addiction treatment gap is a priority.

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

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.

Reducing Opioid Misuse: Evaluation of a Medicaid Controlled Substance Lock-In Program.

Opioid misuse, abuse, and overdose are a rapidly growing public health epidemic. Medicaid Lock-In Programs (MLIPs) are designed to prevent overutilization of controlled substances by Medicaid patients. However, despite widespread use, there is little information on their effect. Using North Carolina (NC) Medicaid claims data from October 2008 through June 2013, we examined changes in Medicaid-reimbursed opioid prescriptions by patients enrolled in NC's MLIP. We used mixed effects models to examine the effect of MLIP enrollment on monthly opioid claims, number of pharmacies, total days' supply, total units (ie, pills), and total Medicaid payments for opioids. In our sample of 6,148 MLIP patients, the odds of having any opioid claim in a given month was 84% lower during MLIP enrollment relative to the period before enrollment (odds ratio = .16). MLIP enrollment also corresponded with a reduction in monthly number of opioid prescriptions by 1.13, monthly number of pharmacies by .61, and monthly Medicaid expenditures by $22.78. Although MLIPs may constitute a successful component of comprehensive efforts to reduce the potential overutilization of opioids, care should be taken to ensure that programs such as MLIPs do not constrain patients' legitimate needs for analgesic medications. PERSPECTIVE: Enrollment in NC's MLIP reduced the likelihood that patients would present a claim for an opioid prescription, and the number of opioid prescriptions patients secured each month. MLIPs may constitute a successful strategy for reducing the misuse, abuse, and diversion of prescription opioids. However, further research is needed to examine the program's potential unintended consequences.

Revisiting the washout period in the incident user study design: why 6-12 months may not be sufficient.

AIMS: The purpose of this study was to describe how washout period duration affects the size and accuracy of retrospective incident user cohorts. MATERIALS & METHODS: MarketScan commercial claims data from 2007 to 2010 were used and included adults with an antihyperlipidemic, antidiabetic or antidepressant claim in 2010. Incident user cohorts using 3-, 6-, 12-, 24- and 36-month washouts were created and changes in sample size and incident user misclassification were described. RESULTS & CONCLUSION: The 6- and 12-month washouts excluded 75 and 85% of the samples, respectively. Half of subjects in the 6-month washout cohorts were actually prevalent users, and the 12-month washout period resulted in 30% misclassified. Using common washout periods of 6-12 months may insufficiently address prevalent user bias in large commercial claims databases.