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BACKGROUND AND AIMS: In a United States randomized-effectiveness trial comparing extended-release naltrexone (XR-NTX) with buprenorphine-naloxone (BUP-NX) for the prevention of opioid relapse among participants recruited during inpatient detoxification (CTN-0051), the requirement to complete opioid detoxification prior to initiating XR-NTX resulted in lower rates of initiation of XR-NTX (72%-XR-NTX vs. 94%-BUP-NX). This led to higher relapse rates and average healthcare costs among XR-NTX participants. This study estimated the extent to which a more efficient model of XR-NTX induction would improve the economic value of XR-NTX relative to BUP-NX. DESIGN: This was a retrospective secondary analysis of CTN-0051 trial data, including follow up data over 24–36 weeks. SETTING: Eight community-based, inpatient-detoxification and follow-up outpatient treatment facilities in the USA. PARTICIPANTS: 283 participants randomized to receive XR-NTX. MEASUREMENTS: Efficiency was estimated using a multivariable generalized-structural-equation model to explore simultaneous determinants of XR-NTX induction and induction duration (detoxification + residential days). Cost-effectiveness was estimated from the healthcare sector perspective and included expected costs and quality-adjusted life-years (QALYs). FINDINGS: Treatment site was the only modifiable factor that simultaneously increased the likelihood of XR-NTX induction and decreased induction duration. Incorporating the higher predicted probability of XR-NTX induction, and fewer predicted days of detoxification and subsequent residential treatment into the cost-effectiveness framework, reduced the incremental average 24-week total cost of XR-NTX treatment from $5,317 more than that of BUP-NX (p=0.01) to a non-statistically-significant difference of $1,016 (p=0.63). QALYs gained remained similar across arms. CONCLUSION: Adopting an efficient model of extended-release naltrexone initiation could result in extended-release naltrexone and buprenorphine-naloxone being of comparable economic value from the healthcare sector perspective over 24–36 weeks for patients seeking treatment for opioid use disorder at an inpatient detoxification facility.

BACKGROUND Since early 2016, an increasing number of states passed legislations that limit the duration and/or dosage of initial opioid prescriptions or opioids for acute pain. OBJECTIVE The objective of this study was to assess changes in the number of opioid prescriptions covered by Medicaid and received by Medicaid patients associated with state implementation of legislative limits on initial opioid prescriptions. RESEARCH DESIGN We explored the natural experiment resulting from the staggered implementation of state legislative limits. The analysis adopted a Difference-in-Differences framework and controlled for other major state policies bearing implications for prescription opioid use. The main analysis included 26 states that implemented limits from early 2016 to late 2018. A secondary analysis included all 50 states and the District of Columbia. MEASURES Population-adjusted state-quarter level counts of Schedule II and III opioid prescriptions received by Medicaid patients, based on data from the Medicaid State Drug Utilization Data and state Medicaid enrollment reports for 2013-2018. RESULTS Implementation of legislative limits on initial opioid prescriptions was associated with a 7% reduction in the number of opioid prescriptions per 100 Medicaid enrollees. Such reduction was largely attributable to a reduction in Schedule II opioid prescriptions. Secondary analysis by including all jurisdictions and sensitivity checks supported the robustness of results. CONCLUSION The recent implementation of state legislative limits on initial opioid prescriptions was associated with meaningful reductions in the volume of Schedule II opioid prescriptions received by Medicaid patients.

Background State policies to optimize prescriber use of Prescription Drug Monitoring Programs (PDMPs) have proliferated in recent years. Prominent policies include comprehensive mandates for prescriber use of PDMP, laws allowing delegation of PDMP access to office staff, and interstate PDMP data sharing. Evidence is limited regarding the effects of these policies on adverse opioid-related hospital events. Objective The objective of this study was to assess the effects of 3 PDMP policies on adverse opioid-related hospital events among patients with prescription opioid use. Research design We examined 2011-2015 data from a large national commercial insurance database of privately insured and Medicare Advantage patients from 28 states with fully operating PDMPs by the end of 2010. We used a difference-in-differences framework to assess the probabilities of opioid-related hospital events and association with the implementation of PDMP policies. The analysis was conducted for adult patients with any prescription opioid use, a subsample of patients with long-term prescription opioid use, and stratified by older (65+) versus younger patients. Results Comprehensive use mandates were associated with a relative reduction in the probability of opioid-related hospital events by 28% among patients with any opioid and 21% among patients with long-term opioid use. Such reduction was greater (in relative terms) among older patients despite the lower rate of these events among older than younger patients. Delegate laws and interstate data sharing were associated with limited change in the outcome. Conclusion Comprehensive PDMP use mandates were associated with meaningful reductions in opioid-related hospital events among privately insured and Medicare Advantage adults with prescription opioid use.

Objective To estimate the own-price elasticity of demand for naloxone, a prescription medication that can counter the effects of an opioid overdose, and predict the change in pharmacy sales following a conversion to over-the-counter status. Data sources/study setting The primary data source was a nationwide prescription claims dataset for 2010-2017. The data cover 80 percent of US retail pharmacies and account for roughly 90 percent of prescriptions filled. Additional covariates were obtained from various secondary data sources. Study design We estimated a longitudinal, simultaneous equation model of naloxone supply and demand. Our primary variables of interest were the quantity of naloxone sold, measured as total milligrams sold at pharmacies, and the out-of-pocket price paid per milligram, both measured per ZIP Code and quarter-year. Data collection/extraction methods Primary data came directly from payers and processors of prescription drug claims. Principal findings We found that, on average, a 1 percent increase in the out-of-pocket price paid for naloxone would result in a 0.27 percent decrease in pharmacy sales. We predict that the total quantity of naloxone sold in pharmacies would increase 15 percent to 179 percent following conversion to over-the-counter status. Conclusions Naloxone is own-price inelastic, and conversion to over-the-counter status is likely to lead to a substantial increase in total pharmacy sales.

Health care providers may play an important role in detection of elder mistreatment, which is common but underrecognized. We used the Health Care Cost Institute insurance claims database to describe elder mistreatment diagnosis among Medicare Advantage (MA) and private insurance patients in the United States from 2011 to 2017. We used International Classification of Diseases (ICD) coding to identify cases, examining the impact of transition from ICD-9 (Ninth Revision) to ICD-10 (Tenth Revision), which occurred in October 2015 and added 14 new codes for “suspected” mistreatment. 8,127 patients (0.051% of all aged ≥ 65), including 6,304 with MA (0.058%) and 1,823 with private insurance (0.026%) received elder mistreatment diagnosis. Transition from ICD-9 to ICD-10 was associated with a small increase in diagnosis rate, with “suspected” codes used in 45.3% of ICD-10 versus 9.7% of ICD-9 cases. Overall rates remained low. Rates, settings, and types of diagnosis differed between MA and private insurance patients.

IntroductionPhysical elder abuse is common and has serious health consequences but is under-recognised and under-reported. As assessment by healthcare providers may represent the only contact outside family for many older adults, clinicians have a unique opportunity to identify suspected abuse and initiate intervention. Preliminary research suggests elder abuse victims may have different patterns of healthcare utilisation than other older adults, with increased rates of emergency department use, hospitalisation and nursing home placement. Little is known, however, about the patterns of this increased utilisation and associated costs. To help fill this gap, we describe here the protocol for a study exploring patterns of healthcare utilisation and associated costs for known physical elder abuse victims compared with non-victims.Methods and analysisWe hypothesise that various aspects of healthcare utilisation are differentially affected by physical elder abuse victimisation, increasing ED/hospital utilisation and reducing outpatient/primary care utilisation. We will obtain Medicare claims data for a series of well-characterised, legally adjudicated cases of physical elder abuse to examine victims’ healthcare utilisation before and after the date of abuse detection. We will also compare these physical elder abuse victims to a matched comparison group of non-victimised older adults using Medicare claims. We will use machine learning approaches to extend our ability to identify patterns suggestive of potential physical elder abuse exposure. Describing unique patterns and associated costs of healthcare utilisation among elder abuse victims may improve the ability of healthcare providers to identify and, ultimately, intervene and prevent victimisation.Ethics and disseminationThis project has been reviewed and approved by the Weill Cornell Medicine Institutional Review Board, protocol #1807019417, with initial approval on 1 August 2018. We aim to disseminate our results in peer-reviewed journals at national and international conferences and among interested patient groups and the public.

Background Persons with an opioid use disorder (OUD) who were incarcerated face many challenges to remaining abstinent; concomitantly, opioid-overdose is the leading cause of death among this population, with the initial weeks following release proving especially fatal. Extended-release naltrexone (XR-NTX) is the most widely-accepted, evidence-based OUD pharmacotherapy in criminal justice settings, and ensures approximately 30 days of protection from opioid overdose. The high cost of XR-NTX serves as a barrier to uptake by many prison/jail systems; however, the cost of the medication should not be viewed in isolation. Prison/jail healthcare budgets are ultimately determined by policymakers, and the benefits/cost-offsets associated with effective OUD treatment will directly and indirectly affect their overall budgets, and society as a whole. Methods This protocol describes a study funded by the National Institute of Drug Abuse (NIDA) to: evaluate changes in healthcare utilization, health-related quality-of-life, and other resources associated with different strategies of XR-NTX delivery to persons with OUD being released from incarceration; and estimate the relative “value” of each strategy. Data from two ongoing, publicly-funded, randomized-controlled trials will be used to evaluate these questions. In Study A, (XR-NTX Before vs. After Reentry), participants are randomized to receive their first XR-NTX dose before release, or at a nearby program post-release. In Study B, (enhanced XR-NTX vs. XR-NTX), both arms receive XR-NTX prior to release; the enhanced arm receives mobile medical (place of residence) XR-NTX treatment post-release, and the XR-NTX arm receives referral to a community treatment program post-release. The economic data collection instruments required to evaluate outcomes of interest were incorporated into both studies from baseline. Moreover, because the same instruments are being used in both trials on comparable populations, we have the opportunity to not only assess differences in outcomes between study arms within each trial, but also to merge the data sets and test for differences across trials. Discussion Initiating XR-NTX for OUD prior to release from incarceration may improve patient health and well-being, while also producing downstream cost-offsets. This study offers the unique opportunity to assess the effectiveness and cost-effectiveness of multiple strategies, according to different stakeholder perspectives.

BackgroundThe Los Angeles County (LAC) Division of HIV and STD Programs implemented a medical care coordination (MCC) program to address the medical and psychosocial service needs of people with HIV (PWH) at risk for poor health outcomes.MethodsOur objective was to evaluate the impact and cost-effectiveness of the MCC program. Using the CEPAC-US model populated with clinical characteristics and costs observed from the MCC program, we projected lifetime clinical and economic outcomes for a cohort of high-risk PWH under 2 strategies: (1) No MCC and (2) a 2-year MCC program. The cohort was stratified by acuity using social and clinical characteristics. Baseline viral suppression was 33% in both strategies; 2-year suppression was 33% with No MCC and 57% with MCC. The program cost $2700/person/year. Model outcomes included quality-adjusted life expectancy, lifetime medical costs, and cost-effectiveness. The cost-effectiveness threshold for the incremental cost-effectiveness ratio (ICER) was $100 000/quality-adjusted life-year (QALY).ResultsWith MCC, life expectancy increased from 10.07 to 10.94 QALYs, and costs increased from $311 300 to $335 100 compared with No MCC (ICER, $27 400/QALY). ICERs for high/severe, moderate, and low acuity were $30 500/QALY, $25 200/QALY, and $77 400/QALY. In sensitivity analysis, MCC remained cost-effective if 2-year viral suppression was ≥39% even if MCC costs increased 3-fold.ConclusionsThe LAC MCC program improved survival and was cost-effective. Similar programs should be considered in other settings to improve outcomes for high-risk PWH.

Comprehensive mandates for prescription drug monitoring programs (PDMPs) require state-licensed prescribers and dispensers both to register with and to use the programs in most clinical circumstances. Such mandates have the potential to improve providers' participation and reduce opioid-related adverse events. Using Medicaid prescription data and hospital utilization data across the US in the period 2011-16, we found that state implementation of comprehensive PDMP mandates was associated with a reduction in the opioid prescription rate from 161.47 to 147.07 per 1,000 enrollees per quarter, a reduction in the opioid-related inpatient stay rate from 97.50 to 93.34 per 100,000 enrollees per quarter, and a reduction in the opioid-related emergency department (ED) visit rate from 74.60 to 61.36 per 100,000 enrollees per quarter. Our estimated annual reductions of approximately 12,000 inpatient stays and 39,000 ED visits could save over $155 million in Medicaid spending, a fact that deserves policy attention when states attempt to strengthen and refine PDMPs to better tackle the opioid crisis.

Objective To examine the health-related quality-of-life (HRQoL) of persons with opioid use disorder (OUD) seeking treatment in an inpatient detoxification or short-term residential setting; continuing treatment as outpatients. Methods We conducted a secondary analysis of data from a clinical trial (N = 508) where participants were randomized to extended-release naltrexone or buprenorphine-naloxone for the prevention of opioid relapse. We used a generalized structural equation regression mixture model to identify associations of HRQoL (EQ-5D) trajectories, including latent characteristics, over the 24-week trial and 36-week follow-up period, among participants who reported HRQoL beyond baseline. This novel framework accounted for baseline and time-varying characteristics, while simultaneously identifying latent classes. Results We identified two subpopulations: HRQoL "pharmacotherapy responsive" (82.3 %) and HRQoL "characteristic sensitive" (17.7 %). The pharmacotherapy responsive subpopulation was characterized by a shortterm HRQoL improvement and then stable HRQoL over time, and by a positive association between HRQoL and receiving pharmacotherapy in the past 30 days. The characteristic sensitive subpopulation was characterized by an initial improvement in HRQoL with a gradual decline over time, and no significant HRQoL response to pharmacotherapy. HRQoL changes over time in this subpopulation were more influenced by baseline demographic, socioeconomic, and psychosocial characteristics. Conclusion Our findings suggest that while HRQoL may be improved and sustained through targeted efforts to promote use of pharmacotherapy for many persons with OUD, an identifiable subpopulation may require additional services that address socioeconomic and psychosocial issues to achieve HRQoL benefits. Our analysis provides insight for improving individualized care for persons with opioid use disorder seeking treatment.

Not enough evidence exists to compare buprenorphine-naloxone with extended-release naltrexone for treating opioid use disorder.To evaluate the cost-effectiveness of buprenorphine-naloxone versus extended-release naltrexone.Cost-effectiveness analysis alongside a previously reported randomized clinical trial of 570 adults in 8 U.S. inpatient or residential treatment programs.Study instruments.Adults with opioid use disorder.24-week intervention with an additional 12 weeks of observation.Health care sector and societal.Buprenorphine-naloxone and extended-release naltrexone.Incremental costs combined with incremental quality-adjusted life-years (QALYs) and incremental time abstinent from opioids.Use of the health care sector perspective and a willingness-to-pay threshold of $100 000 per QALY showed buprenorphine-naloxone to be preferable to extended-release naltrexone in 97% of bootstrap replications at 24 weeks and in 85% at 36 weeks. Similar results were obtained with incremental time abstinent from opioids as an outcome and with use of the societal perspective.The base-case results were sensitive to the cost of the 2 treatments and the success of randomized treatment initiation.Relatively short follow-up for a chronic condition, substantial missing data, no information on patient out-of-pocket and social service costs.Buprenorphine-naloxone is preferred to extended-release naltrexone as first-line treatment when both options are clinically appropriate and patients require detoxification before initiating extended-release naltrexone.National Institute on Drug Abuse, National Institutes of Health.

BACKGROUND: Collaborative Care (CoCM) is an evidence-based model for treating depression in primary care. Little is known about its implementation “learning curve” in non-research settings. METHODS: The authors used eight years of observational data from Washington State’s Mental Health Integration Program (MHIP) to describe organization-level changes in clinical and process-of-care outcomes over time. RESULTS: The authors analyzed data from 13,362 unique patients within eight Community Health Centers (CHCs) in Washington State. On average, clinical outcomes improved for the first two years before improvement slowed, peaking at year five. Significant organization-level variation was noted in outcomes. Improvements in clinical outcomes tended to track process-of-care measures. CONCLUSIONS: Findings suggest that it may take two years post-implementation of CoCM to fully observe organization-level clinical outcome improvement. Substantial between-organization variation in outcomes over time suggests that sustained attention to processes-of-care and quality may be necessary to maintain initially achieved gains.

Policies and practices have proliferated to optimize prescribers' use of their states' prescription drug monitoring programs, which are statewide databases of controlled substances dispensed at retail pharmacies. Our study assessed the effectiveness of three such policies: comprehensive legislative mandates to use the program, laws that allow prescribers to delegate its use to office staff, and state participation in interstate data sharing. Our analysis of information from a large commercial insurance database indicated that comprehensive use mandates implemented during 2011-15 were associated with a 6-9 percent reduction in opioid prescriptions with high risk for misuse and overdose. We also found delegate laws to be associated with reductions of a similar magnitude for selected outcomes. In general, the effects of all three policies strengthened over time, especially beginning in the second year after implementation. Our findings support comprehensive use mandates and delegate laws to optimize prescribers' use of drug monitoring programs, but the results will need updates in the context of evolving state opioid policies-including the increasing integration of drug monitoring data with electronic health records.

BACKGROUND: National guidelines make recommendations regarding the initial opioid prescriptions, but most of the supporting evidence is from the initial episode of care, not the first prescription. OBJECTIVE: To examine associations between features of the first opioid prescription and high-risk opioid use in the 18 months following the first prescription. DESIGN: Retrospective cohort study using data from a large commercial insurance claims database for 2011–2014 to identify individuals with no recent use of opioids and follow them for 18 months after the first opioid prescription. PARTICIPANTS: Privately insured patients aged 18–64 and Medicare Advantage patients aged 65 or older who filled a first opioid prescription between 07/01/2011 and 06/30/2013. MAIN OUTCOMES AND MEASURES: High-risk opioid use was measured by having (1) opioid prescriptions overlapping for 7 days or more, (2) opioid and benzodiazepine prescriptions overlapping for 7 days or more, (3) three or more prescribers of opioids, and (4) a daily dosage exceeding 120 morphine milligram equivalents, in each of the six quarters following the first prescription. KEY RESULTS: All three features of the first prescription were strongly associated with high-risk use. For example, among privately insured patients, receiving a long- (vs. short-) acting first opioid was associated with a 16.9-percentage-point increase (95% CI, 14.3–19.5), a daily MME of 50 or more (vs. less than 30) was associated with a 12.5-percentage-point increase (95% CI, 12.1–12.9), and a supply exceeding 7 days (vs. 3 or fewer days) was associated with a 4.8-percentage-point increase (95% CI, 4.5–5.2), in the probability of having a daily dosage of 120 MMEs or more in the long term, compared to a sample mean of 4.2%. Results for the Medicare Advantage patients were similar. CONCLUSIONS: Long-acting formulation, high daily dosage, and longer duration of the first opioid prescription were each associated with increased high-risk use of opioids in the long term. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s11606-018-4628-y) contains supplementary material, which is available to authorized users.

OBJECTIVE: This study aims to examine whether, in a large implementation program of collaborative care in safety net primary care clinics, psychiatric case review is associated with depression medication modification. METHODS: Registry data were examined from an implementation of the collaborative care model (CCM) in Washington State and included adults from 178 primary care clinics with baseline Patient Health Questionnaire-9 (PHQ-9) scores ≥10 (n = 14,960). Psychiatric case reviews and depression medications were extracted from the registry. Rates of new depression medications and psychiatric case reviews were calculated for all patients and in the subset of patients not improving by 8 weeks of treatment (defined as not achieving a PHQ-9 score of

Medicaid program criteria for accessing hepatitis C treatment are changing. Medicaid drug utilization data from 2014 to 2016 show that programs that have relaxed their criteria have seen significant increases in treatment utilization, as have states with Medicaid expansions.