The association between naloxone claims and proportion of independent vs. chain pharmacies: A longitudinal analysis of naloxone claims in the US.

BACKGROUND: Expanding access to naloxone through pharmacies is an important policy goal. Our objective was to characterize national county-level naloxone dispensing of chain versus independent pharmacies. METHODS: The primary exposure in our longitudinal analysis was the proportion of chain pharmacies in a county, identified through the US Department of Homeland Security 2010 Infrastructure Foundation-Level Data. We defined counties as having "higher proportion" of chain pharmacies if at least 50% of pharmacies were large national chains. The primary outcome was quarter-year (2016Q1-2019Q2) rate of pharmacy naloxone claims per 100,000 persons from Symphony Health at the county-level. We compared the naloxone dispensing rate between county types using two-sample t-tests. We estimated the association between county-level chain pharmacy proportion and rate of naloxone claims using a linear model with year-quarter fixed effects. RESULTS: Nearly one third of counties (n=946) were higher proportion. Higher proportion counties had a significantly higher rate of naloxone claims across the study period, in 4 of 6 urban-rural classifications, and in counties with and without naloxone access laws. The linear model confirmed that higher proportion counties had a significantly higher rate of naloxone claims, adjusting for urban/rural designation, income, population characteristics, opioid mortality rate, co-prescribing laws and naloxone access laws. CONCLUSION: In this national study, we found an association between naloxone dispensing rates and the county-level proportion of chain (versus independent) pharmacies. Incentivizing naloxone dispensing through educational, regulatory, or legal efforts may improve naloxone availability and dispensing rates - particularly in counties with proportionately high numbers of independent pharmacies.

Determining the lower limit of detection required for HCV viral load assay for test of cure following direct-acting antiviral-based treatment regimens: Evidence from a global data set.

Achieving global elimination of hepatitis C virus requires a substantial scale-up of testing. Point-of-care HCV viral load assays are available as an alternative to laboratory-based assays to promote access in hard to reach or marginalized populations. The diagnostic performance and lower limit of detection are important attributes of these new assays for both diagnosis and test of cure. Therefore, our objective was to determine an acceptable LLoD for detectable HCV viraemia as a test for cure, 12 weeks post-treatment (SVR12). We assembled a global data set of patients with detectable viraemia at SVR12 from observational databases from 9 countries (Egypt, the United States, United Kingdom, Georgia, Ukraine, Myanmar, Cambodia, Pakistan, Mozambique) and two pharmaceutical-sponsored clinical trial registries. We examined the distribution of HCV viral load at SVR12 and presented the 90th, 95th, 97th and 99th percentiles. We used logistic regression to assess characteristics associated with low-level virological treatment failure (defined as <1000 IU/mL). There were 5973 cases of detectable viraemia at SVR12 from the combined data set. Median detectable HCV RNA at SVR12 was 287,986 IU/mL. The level of detection for the 95th percentile was 227 IU/mL (95% CI 170-276). Females and those with minimal fibrosis were more likely to experience low-level viraemia at SVR12 compared to men (adjusted odds ratio AOR = 1.60 95% confidence interval [CI] 1.30-1.97 and those with cirrhosis (AOR = 1.49 95% CI 1.15-1.93). In conclusion, an assay with a level of detection of 1000 IU/mL or greater may miss a proportion of those with low-level treatment failure.

Variation in Initiation, Engagement, and Retention on Medications for Opioid Use Disorder Based on Health Insurance Plan Design.

BACKGROUND: The association between cost-sharing and receipt of medication for opioid use disorder (MOUD) is unknown. METHODS: We constructed a cohort of 10,513 commercially insured individuals with a new diagnosis of opioid use disorder and information on insurance cost-sharing in a large national deidentified claims database. We examined 4 cost-sharing measures: (1) pharmacy deductible; (2) medical service deductible; (3) pharmacy medication copay; and (4) medical office copay. We measured MOUD (naltrexone, buprenorphine, or methadone) initiation (within 14 d of diagnosis), engagement (second receipt within 34 d of first), and 6-month retention (continuous receipt without 14-d gap). We used multivariable logistic regression to assess the association between cost-sharing and MOUD initiation, engagement, and retention. We calculated total out-of-pocket costs in the 30 days following MOUD initiation for each type of MOUD. RESULTS: Of 10,513 individuals with incident opioid use disorder, 1202 (11%) initiated MOUD, 742 (7%) engaged, and 253 (2%) were retained in MOUD at 6 months. A high ($1000+) medical deductible was associated with a lower odds of initiation compared with no deductible (odds ratio: 0.85, 95% confidence interval: 0.74-0.98). We found no significant associations between other cost-sharing measures for initiation, engagement, or retention. Median initial 30-day out-of-pocket costs ranged from $100 for methadone to $710 for extended-release naltrexone. CONCLUSIONS: Among insurance plan cost-sharing measures, only medical services deductible showed an association with decreased MOUD initiation. Policy and benefit design should consider ways to reduce cost barriers to initiation and retention in MOUD.

Underscreening, overscreening, and guideline-adherent cervical cancer screening in a national cohort.

OBJECTIVE: To explore rates of under- and overscreening for cervical cancer among a national cohort. METHODS: The MarketScan database, a national administrative database of employee-sponsored insurance, was queried for elements relevant to cervical cancer screening among women aged 21-65 with 6 years of continuous enrollment (2015-2019). Average-risk women were defined as those without high-risk medical conditions or abnormal screening histories, and without evidence of hysterectomy with removal of the cervix for benign indications. Average-risk women were considered adequately screened if they had Pap tests alone at 2.5-3.5 year intervals, or HPV tests or co-tests at 4.5-5.5 year intervals. Logistic regressions were used to predict the odds of receiving guideline-adherent screening, underscreening, and overscreening. RESULTS: Among 1,872,809 eligible patients, 1,471,063 (78.5%) qualified for routine screening. Of these, only 18.1% received guideline-adherent screening, and 25.4% were unscreened during the 6-year period. Younger women (aged 21-39) were more likely to be overscreened [OR 1.46]. Older women (aged 50-64) were more likely to be underscreened or unscreened during the study period [OR 2.54]. Guideline-adherent screening was highest with HPV testing alone (80%) followed by co-testing (44%), and lowest with cytology alone (15%). A total of 329,062 women in this general population sample (18%) met high-risk criteria that required increased frequency of screening. CONCLUSIONS: High rates of both underscreening and overscreening indicate a need for additional strategies to improve guideline-adherent care. CLINICAL TRIAL REGISTRATION: N/A.

Outcomes Associated With Medications for Opioid Use Disorder Among Persons Hospitalized for Infective Endocarditis.

BACKGROUND: Endocarditis, once predominately found in older adults, is increasingly common among younger persons who inject drugs. Untreated opioid use disorder (OUD) complicates endocarditis management. We aimed to determine if rates of overdose and rehospitalization differ between persons with OUD with endocarditis who are initiated on medications for OUD (MOUDs) within 30 days of hospital discharge and those who are not. METHODS: We performed a retrospective cohort study using a large commercial health insurance claims database of persons ≥18 years between July 1, 2010, and June 30, 2016. Primary outcomes included opioid-related overdoses and 1-year all-cause rehospitalization. We calculated incidence rates for the primary outcomes and developed Cox hazards models to predict time from discharge to each primary outcome as a function of receipt of MOUDs. RESULTS: The cohort included 768 individuals (mean age 39 years, 51% male). Only 5.7% of people received MOUDs in the 30 days following hospitalization. The opioid-related overdose rate among those who did receive MOUDs in the 30 days following hospitalization was lower than among those who did not (5.8 per 100 person-years [95% confidence interval [CI], 5.1-6.4] vs 7.3 per 100-person years [95% CI, 7.1-7.5], respectively). The rate of 1-year rehospitalization among those who received MOUDs was also lower than those who did not (162.0 per 100 person-years [95% CI, 157.4-166.6] vs 255.4 per 100 person-years [95% CI, 254.0-256.8], respectively). In the Cox hazards models, the receipt of MOUDs was not associated with either of the outcomes. CONCLUSIONS: MOUD receipt following endocarditis may improve important health-related outcomes in commercially insured persons with OUD.

Eligibility for cervical cancer screening exit: Comparison of a national and safety net cohort.

OBJECTIVE: To determine eligibility for discontinuation of cervical cancer screening. METHODS: Women aged 64 with employer-sponsored insurance enrolled in a national database between 2016 and 2018, and those aged 64-66 receiving primary care at a safety net health center in 2019 were included. Patients were evaluated for screening exit eligibility by current guidelines: no evidence of cervical cancer or HIV-positive status and no evidence of cervical precancer in the past 25 years, and had evidence of either hysterectomy with removal of the cervix or evidence of fulfilling screening exit criteria, defined as two HPV screening tests or HPV plus Pap co-tests or three Pap tests within the past 10 years without evidence of an abnormal result. RESULTS: Of the 590,901 women in the national claims database, 131,059 (22.2%) were eligible to exit due to hysterectomy (1.6%) or negative screening (20.6%). Of the 1544 women from the safety net health center, 528 (34.2%) were eligible to exit due to hysterectomy (9.3%) or negative screening (24.9%). Most women did not have sufficient data available to fulfill exit criteria: 382,509 (64.7%) in the national database and 875 (56.7%) in the safety net hospital system. Even among women with 10 years of insurance claims data, only 41.5% qualified to discontinue screening. CONCLUSIONS: Examining insurance claims in a national database and electronic medical records at a safety net institution led to remarkably similar findings: two thirds of women fail to qualify for screening exit. Additional steps to ensure eligibility prior to screening exit may be necessary to decrease preventable cervical cancers among women aged >65. CLINICAL TRIAL REGISTRATION: N/A.

Cost-effectiveness of Hepatitis C Virus Treatment Models for People Who Inject Drugs in Opioid Agonist Treatment Programs.

BACKGROUND: Many people who inject drugs in the United States have chronic hepatitis C virus (HCV). On-site treatment in opiate agonist treatment (OAT) programs addresses HCV treatment barriers, but few evidence-based models exist. METHODS: We evaluated the cost-effectiveness of HCV treatment models for OAT patients using data from a randomized trial conducted in Bronx, New York. We used a decision analytic model to compare self-administered individual treatment (SIT), group treatment (GT), directly observed therapy (DOT), and no intervention for a simulated cohort with the same demographic characteristics of trial participants. We projected long-term outcomes using an established model of HCV disease progression and treatment (hepatitis C cost-effectiveness model: HEP-CE). Incremental cost-effectiveness ratios (ICERs) are reported in 2016 US$/quality-adjusted life years (QALY), discounted 3% annually, from the healthcare sector and societal perspectives. RESULTS: For those assigned to SIT, we projected 89% would ever achieve a sustained viral response (SVR), with 7.21 QALYs and a $245 500 lifetime cost, compared to 22% achieving SVR, with 5.49 QALYs and a $161 300 lifetime cost, with no intervention. GT was more efficient than SIT, resulting in 0.33 additional QALYs and a $14 100 lower lifetime cost per person, with an ICER of $34 300/QALY, compared to no intervention. DOT was slightly more effective and costly than GT, with an ICER > $100 000/QALY, compared to GT. In probabilistic sensitivity analyses, GT and DOT were preferred in 91% of simulations at a threshold of <$100 000/QALY; conclusions were similar from the societal perspective. CONCLUSIONS: All models were associated with high rates of achieving SVR, compared to standard care. GT and DOT treatment models should be considered as cost-effective alternatives to SIT.

Patient Outcomes Following Total Joint Replacement Surgery: A Comparison of Hospitals and Ambulatory Surgery Centers.

BACKGROUND: For several years, many orthopedic surgeons have been performing total joint replacements in hospital outpatient departments (HOPDs) and more recently in ambulatory surgery centers (ASCs). In a recent shift, the Centers for Medicare and Medicaid Services began reimbursing for total knee replacement surgery in HOPDs. Some observers have expressed concerns over patient safety for the Medicare population particularly if Centers for Medicare and Medicaid Services extends the policy to include total hip replacement surgery and coverage in ASCs. METHODS: This study used a large claims database of non-Medicare patients to examine inpatient and outpatient total knee replacement and total hip replacement surgery performed on a near-elderly population during 2014-2016. We applied propensity score methods to match inpatients with ASC patients and HOPD patients with ASC patients adjusting for risk using the HHS Hierarchical Condition Categories risk adjustment model. We conducted statistical tests comparing clinical outcomes across the 3 settings and examined relative costs. RESULTS: Readmissions, postsurgical complications, and payments were lower for outpatients than for inpatients. Within outpatient settings, readmissions and postsurgical complications were lower in ASCs than in HOPDs but payments for ASC patients were higher than payments for HOPD patients. CONCLUSION: Our findings support the argument that outpatient total joint replacement is appropriate for select patients treated in both HOPDs and ASCs, although in the commercially insured population, the latter services may come at a cost. Until further study of outpatient total joint replacement in the Medicare population becomes available, how this will extrapolate to the Medicare population is unknown.

Estimated Prevalence of Opioid Use Disorder in Massachusetts, 2011-2015: A Capture-Recapture Analysis.

OBJECTIVES: To estimate the annual prevalence of opioid use disorder (OUD) in Massachusetts from 2011 to 2015. METHODS: We performed a multisample stratified capture-recapture analysis to estimate OUD prevalence in Massachusetts. Individuals identified from 6 administrative databases for 2011 to 2012 and 7 databases for 2013 to 2015 were linked at the individual level and included in the analysis. Individuals were stratified by age group, sex, and county of residence. RESULTS: The OUD prevalence in Massachusetts among people aged 11 years or older was 2.72% in 2011 and 2.87% in 2012. Between 2013 and 2015, the prevalence increased from 3.87% to 4.60%. The greatest increase in prevalence was observed among those in the youngest age group (11-25 years), a 76% increase from 2011 to 2012 and a 42% increase from 2013 to 2015. CONCLUSIONS: In Massachusetts, the OUD prevalence was 4.6% among people 11 years or older in 2015. The number of individuals with OUD is likely increasing, particularly among young people.

Implementation of a nationwide health economic consultation service to assist substance use researchers: Lessons learned.

BACKGROUND: Health economic evaluation findings assist stakeholders in improving the quality, availability, scalability, and sustainability of evidence-based services, and in maximizing the efficiency of service delivery. The Center for Health Economics of Treatment Interventions for Substance Use Disorders, HCV, and HIV (CHERISH) is a NIDA-funded multi-institutional center of excellence whose mission is to develop and disseminate health-economic research on healthcare utilization, health outcomes, and health-related behaviors that informs substance use disorder treatment policy, and HCV and HIV care of people who use substances. METHODS: We designed a consultation service that is free to researchers whose work aligns with CHERISH's mission. The service includes up to six hours of consulting time. After prospective consultees submit their request online, they receive a screening call from the consultation service director, who connects them with a consultant with relevant expertise. Consultees and consultants complete web-based evaluations following the consultation; consultees also complete a six-month follow-up. We report on the status of the service from its inception in July 2015 through June 2017. RESULTS: We have received 28 consultation requests (54% Early Stage Investigators, 57% MD or equivalent, 28% PhD, 61% women) on projects typically related to planning a study or grant application (93%); 71% were HIV/AIDS-related. Leading topics included cost-effectiveness (43%), statistical-analysis/econometrics (36%), cost (32%), cost-benefit (21%), and quality-of-life (18%). All consultees were satisfied with their overall experience, and felt that consultation expectations and objectives were clearly defined and the consultant's expertise was matched appropriately with their needs. Results were similar for consultants, who spent a median of 3 hours on consultations. CONCLUSIONS: There is a need for health-economic methodological guidance among substance use, HCV, and HIV researchers. Lessons learned pertain to the feasibility of service provision, the need to implement systems to measure and improve service value, and strategies for service promotion.

Economic evaluation of HCV testing approaches in low and middle income countries.

BACKGROUND: Hepatitis C virus (HCV) infection represents a major public health burden with diverse epidemics worldwide, but at present, only a minority of infected persons have been tested and are aware of their diagnosis. The advent of highly effective direct acting antiviral (DAA) therapy, which is becoming available at increasingly lower costs in low and middle income countries (LMICs), represents a major opportunity to expand access to testing and treatment. However, there is uncertainty as to the optimal testing approaches and who to prioritize for testing. We undertook a narrative review of the cost-effectiveness literature on different testing approaches for chronic hepatitis C infection to inform decision-making and formulation of recommendations in the 2017 World Health Organization (WHO) viral hepatitis testing guidelines. METHODS: We undertook a focused search and narrative review of the literature for cost effectiveness studies of testing approaches in three main groups:- 1) focused testing of specific high-risk groups (defined as those who are part of a population with higher seroprevalence or who have a history of exposure or high-risk behaviours); 2) "birth cohort" testing among easily identified age groups (i.e. specific birth cohorts) known to have a high prevalence of HCV infection; and 3) routine testing in the general population. Articles included were those published in PubMed, written in English and published after 2000. RESULTS: We identified 26 eligible studies. Twenty-four of them were from Europe (n = 14) or the United States (n = 10). There was only one study from a LMIC (Egypt) and this evaluated general population testing. Thirteen studies evaluated focused testing among specific groups at high risk for HCV infection, including nine in persons who inject drugs (PWID); five among people in prison, and one among HIV-infected men who have sex with men (MSM). Eight studies evaluated birth cohort testing, and five evaluated testing in the general population. Most studies were based on a one-time testing intervention, but in one study testing was undertaken every 5 years and in another among HIV-infected MSM there was more frequent testing. Comparators were generally either: 1) no testing, 2) the status quo, or 3) multiple different strategies. Overall, we found broad agreement that focused testing of high risk groups such as persons who inject drugs and men who have sex with men was cost-effective, as was birth cohort testing. Key drivers of cost-effectiveness were the prevalence of HCV infection in these groups, efficacy and cost of treatment, stage of disease and linkage to care. The evidence for routine population testing was mixed, and the cost-effectiveness depends largely on the prevalence of HCV. CONCLUSIONS: The evidence base for different HCV testing approaches in LMICs is limited, minimizing the contribution of cost-effectiveness data alone to decision-making and recommendations on testing approaches in the 2017 WHO viral hepatitis testing guidelines. Overall, the guidelines recommended focused testing in high risk-groups, particularly PWID, prisoners, and men who have sex with men; with consideration of two other approaches:- birth cohort testing in those countries with epidemiological evidence of a significant birth cohort effect; and routine access to testing across the general population in those countries with a high HCV seroprevalence above 2% - 5% in the general population. Further implementation research on different testing approaches is needed in order to help guide national policy planning.

Getting What You Pay For: The Economics of Quality Care for Sexually Transmitted Infections.

BACKGROUND: Understanding the relationship between charges, reimbursement, and quality for sexually transmitted infection (STI) care is necessary to evaluate consequences of shifting patients from STI specialty to nonspecialty settings and to inform quality improvement efforts in this area. METHODS: Chart reviews were used to evaluate quality of documented STI care among 450 patients across 5 different clinical settings within a large safety net hospital in Massachusetts for patients presenting with penile discharge/dysuria or vaginal discharge. Charges billed and recouped by the hospital for each visit were extracted from billing records. Univariate methods examined unadjusted differences between quality and other patient and practice characteristics, and charges billed and recouped, whereas a multivariable model predicted the effect of quality on charges and reimbursements after adjusting for potential confounders. RESULTS: Higher documented quality of care was associated with higher charges, with each additional quality point predicting a 9% increase in visit charges. However, these charges were not recouped by the institution, as quality was not associated with higher levels of hospital reimbursement. Among sites of care, the STI clinic had the highest average quality score, as well as the lowest average amount billed and recouped. CONCLUSIONS: The relationship we find between documented quality and charges billed may reflect resource use for patient visits. The hospital, however, did not recoup any more on average from higher-quality visits, thus posing an incentive problem for the institution. Our findings suggest that loss of government funds for STI clinics may not be replaced by hospital billing and may lead to lower quality of care.

The cost-effectiveness of sofosbuvir-based regimens for treatment of hepatitis C virus genotype 2 or 3 infection.

BACKGROUND: Chronic infection with hepatitis C virus (HCV) genotype 2 or 3 can be treated with sofosbuvir without interferon. Because sofosbuvir is costly, its benefits should be compared with the additional resources used. OBJECTIVE: To estimate the cost-effectiveness of sofosbuvir-based treatments for HCV genotype 2 or 3 infection in the United States. DESIGN: Monte Carlo simulation, including deterministic and probabilistic sensitivity analyses. DATA SOURCES: Randomized trials, observational cohorts, and national health care spending surveys. TARGET POPULATION: 8 patient types defined by HCV genotype (2 vs. 3), treatment history (naive vs. experienced), and cirrhosis status (noncirrhotic vs. cirrhotic). TIME HORIZON: Lifetime. PERSPECTIVE: Payer. INTERVENTION: Sofosbuvir-based therapies, pegylated interferon-ribavirin, and no therapy. OUTCOME MEASURES: Discounted quality-adjusted life-years (QALYs), costs, and incremental cost-effectiveness ratios (ICERs). RESULTS OF BASE-CASE ANALYSIS: The ICER of sofosbuvir-based treatment was less than $100,000 per QALY in cirrhotic patients (genotype 2 or 3 and treatment-naive or treatment-experienced) and in treatment-experienced noncirrhotic patients but was greater than $200,000 per QALY in treatment-naive noncirrhotic patients. RESULTS OF SENSITIVITY ANALYSIS: The ICER of sofosbuvir-based therapy for treatment-naive noncirrhotic patients with genotype 2 or 3 infection was less than $100,000 per QALY when the cost of sofosbuvir was reduced by approximately 40% and 60%, respectively. In probabilistic sensitivity analyses, cost-effectiveness conclusions were robust to uncertainty in treatment efficacy. LIMITATION: The analysis did not consider possible benefits of preventing HCV transmission. CONCLUSION: Sofosbuvir provides good value for money for treatment-experienced patients with HCV genotype 2 or 3 infection and those with cirrhosis. At their current cost, sofosbuvir-based regimens for treatment-naive noncirrhotic patients exceed willingness-to-pay thresholds commonly cited in the United States. PRIMARY FUNDING SOURCE: National Institute on Drug Abuse and National Institute of Allergy and Infectious Diseases.

Evaluating Quality of Care for Sexually Transmitted Infections in Different Clinical Settings.

BACKGROUND: We examined quality of care across different clinical settings within a large safety-net hospital in Massachusetts for patients presenting with penile discharge/dysuria or vaginal discharge. METHODS: Using a modified Delphi approach, a list of sex-specific sexually transmitted infection (STI) quality measures, covering 7 domains of clinical care (history, examination, laboratory testing, assessment, treatment, additional screening, counseling), was selected as standard of care by a panel of 5 STI experts representing emergency department (ED), obstetrics/gynecology (Ob/Gyn), family medicine (FM), primary care (PC), and infectious disease. Final measures were piloted with 50 charts per sex from the STI Clinic and age, sex, and visit date-matched charts from PC, FM, ED, and Ob/Gyn. Performance was scored as compliance among individual measures within 7 domains, standardized to add up to one to adjust for variable number of measures per domain, with an overall score of 7 indicating complete adherence to standards. RESULTS: Expert review process took 2 weeks and resulted in 24 and 34 final measures for male and female patients, respectively. Performance on 7 clinical domains ranged from 3.16 to 4.36 for male patients and 3.17 to 4.33 for female patients. Sexually transmitted infection clinic seemed to score higher on laboratory testing, additional screening, and counseling, but lower on examination and assessment, and ED seemed to score higher on examination and treatment, PC and FM on laboratory testing for male patients and on examination and treatment for female patients, and Ob/Gyn on treatment. CONCLUSIONS: An instrument to discern standard of care and identify strengths and weaknesses in specific domains of clinical documentation for patients presenting with STI complaints can be developed and implemented for quality evaluation across care settings. Further research is needed on whether these findings can be integrated into site-specific quality improvement processes and linked to cost analyses.

Characteristics of patients who accept and decline ED rapid HIV testing.

PURPOSE: Understanding differences between patients who accept and decline HIV testing is important for developing methods to reduce decliner rates among patients at risk for undiagnosed HIV. The objectives of this study were to determine the rates of acceptance and reasons for declining, and to determine if differences exist in patient or visit characteristics between those who accept and decline testing. BASIC PROCEDURES: This was a retrospective medical record review of all patients offered an emergency department (ED) HIV test from 11/1/11 to 10/31/12. Patient demographic characteristics, health characteristics, and ED visit characteristics were compared to assess differences between those who accept and those who decline testing. FINDINGS: Of 4510 ED patients offered an HIV test, 3470 accepted for an acceptance rate of 77%. The most common reasons for declining were "no perceived risk" and "tested in the last 3 months." Those who accepted testing were more likely to be unmarried, less than age 35, Hispanic or African American, Spanish speaking, foreign born, have no primary care provider, report no pain at triage, have a daytime ED visit, and be discharged from the ED compared to admitted. Sex, employment status, and ED length of stay did not affect whether patients accepted testing. PRINCIPAL CONCLUSIONS: Acceptance of ED-based rapid HIV testing is not universal, and there are both patient and visit characteristics consistently associated with declining testing. This detracts from the goal of using the ED to screen a large number of at-risk patients who do not have access to testing elsewhere.

Out-of-pocket spending and health care utilization associated with initiation of different medications for opioid use disorder: Findings from a national commercially insured cohort.

INTRODUCTION: Buprenorphine and naltrexone are effective medications for opioid use disorder (MOUD). Naltrexone requires complete detoxification from opioids before initiation while buprenorphine does not, which leads to a differential clinical induction challenge. Few studies have evaluated economic costs associated with MOUD initiation. METHODS: We conducted a retrospective cohort analysis using the 2014-2019 Merative MarketScan database. We included individuals diagnosed with opioid use, abuse, or dependence from 2014 to 2019 who initiated one of three MOUD types: 1) buprenorphine, 2) extended-release naltrexone, or 3) oral naltrexone. We calculated total and monthly out-of-pocket spending, for overall and MOUD-specific claims, for the three months prior through three months after MOUD initiation. We also calculated utilization of detoxification, inpatient, and outpatient services monthly over this period. RESULTS: Our cohort included 27,133 individuals; 19,536, 1886, and 5711 initiated buprenorphine, extended-release naltrexone, and oral naltrexone, respectively. Individuals who initiated naltrexone had the highest out-of-pocket spending over the study period. MOUD-specific spending did not contribute substantially to total out-of-pocket spending. Difference in overall spending by MOUD type was driven by a subset of individuals who initiated naltrexone and had very high out-of-pocket spending in the month prior to MOUD initiation. In this month, mean monthly out-of-pocket spending for high-spenders (above 90th percentile within MOUD type category) was $5734 (95 % confidence interval [CI]: $5181-$6286) and $4622 (95 % CI: $4161-$5082) for those who initiated oral and extended-release naltrexone, respectively, compared with $1852 (95 % CI: $1754-$1950) for those who initiated buprenorphine. In the month prior to MOUD initiation, those who initiated naltrexone also had higher detoxification, inpatient, and outpatient episode/visit frequency. In the month prior to initiation, 28.8 % (95 % CI: 27.7 %-30.0 %) and 25.5 % (95 % CI: 23.6 %-27.5 %) of individuals who initiated oral and extended-release naltrexone had detoxification episodes, compared with 9.7 % (95 % CI: 9.3 %-10.1 %) of those who initiated buprenorphine. CONCLUSION: Findings suggest that individuals who initiated naltrexone utilized more intensive health services, including detoxification, in the period prior to MOUD initiation, resulting in significantly higher out-of-pocket spending. Out-of-pocket spending is a patient-centered outcome reflecting potential patient burden. Our results should be considered as part of the shared decision-making process between patients and providers when choosing treatment for OUD.

Trends in Attention-Deficit Hyperactivity Disorder Diagnosis and Pharmacotherapy Among Adults With Opioid Use Disorder.

OBJECTIVE: This study aimed to assess nationwide trends in attention-deficit hyperactivity disorder (ADHD) diagnoses and pharmacotherapy among patients with opioid use disorder and ADHD and to examine factors predicting receipt of stimulant medications among patients receiving medications for opioid use disorder (MOUDs). METHODS: A claims-based database of commercially insured patients ages 13-64 was used to conduct two analyses: an annual cross-sectional study of 387,980 patients diagnosed as having opioid use disorder (2007-2017) to estimate the prevalence of ADHD diagnoses and pharmacotherapy, and a retrospective cohort study of 158,591 patients receiving MOUDs to test, with multivariable regression, the association between patient characteristics and receipt of stimulant medication. RESULTS: From 2007 to 2017, the prevalence of ADHD diagnoses increased from 4.6% to 15.1% and the rate of ADHD pharmacotherapy increased from 42.6% to 51.8% among patients with opioid use disorder. Among all patients receiving MOUDs, 10.5% received at least one prescription stimulant during the study period. Female sex; residence in the southern United States; and ADHD, mood, and anxiety disorder diagnoses were associated with increased likelihood of stimulant receipt. Stimulant use disorder and other substance use disorder diagnoses were associated with decreased likelihood of stimulant receipt. CONCLUSIONS: ADHD diagnoses and pharmacotherapy among patients with opioid use disorder have increased. A minority of patients with ADHD and taking MOUDs received a stimulant. Further study is needed of the benefits and risks of ADHD pharmacotherapy for patients with opioid use disorder.

Establishing a Protocol for Determining the Costs of an Integrated Set of Evidence-based Practices Aimed at Reducing Opioid Overdose Deaths.

OBJECTIVES: In the midst of the opioid overdose crisis, local jurisdictions face a choice of public health interventions. A significant barrier when considering evidence-based practices (EBPs) is the lack of information regarding their implementation cost. This protocol paper provides the methodological foundation for the economic cost evaluations of community-wide strategies on the scale of a national study. It can serve as a resource for other communities, local policymakers, and stakeholders as they consider implementing possible public health strategies in their unique settings. METHODS: We present a protocol that details (1) the process of identifying, reviewing, and analyzing individual strategies for study-funded and non-study-funded costs; (2) prospective costing tool designation, and; (3) data collection. To do this, we set up working groups with community stakeholders, reviewed financial invoices, and surveyed individuals with detailed knowledge of their community implementation. DISCUSSION: There were 3 main challenges/limitations. The first was the lack of a standard structure for documenting nonfunded costs associated with each strategy. The second was the need for timely implementation of cost data. The third was generalizability because our study designed its strategies for selected communities due to their high opioid overdose mortality rates. Future steps include more tailored questions to ask during the categorization/filter process and establishing realistic expectations for organizations regarding documenting. CONCLUSIONS: Data collected will provide a critical methodological foundation for costing large community-based EBP strategies and provide clarity for stakeholders on the cost of implementing EBP strategies to reduce opioid overdose deaths.

Evaluation of Strategies to Enhance Community-Based Naloxone Distribution Supported by an Opioid Settlement.

Importance: Many US states are substantially increasing community-based naloxone distribution, supported in part through settlements from opioid manufacturers and distributors. Objectives: To evaluate the potential impact of increased naloxone availability on opioid overdose deaths (OODs) and explore strategies to enhance this impact by integrating interventions to address solitary drug use. Design, Setting, and Participants: This decision analytical modeling study used PROFOUND (Prevention and Rescue of Fentanyl and Other Opioid Overdoses Using Optimized Naloxone Distribution Strategies), a previously published simulation model, to forecast annual OODs between January 2023 and December 2025. The simulated study population included individuals from Rhode Island who misused opioids and stimulants and were at risk for opioid overdose. Exposures: The study modeled expanded naloxone distribution supported by the state's opioid settlement (50 000 naloxone nasal spray kits each year). Two approaches to expanding naloxone distribution were evaluated: one based on historical spatial patterns of naloxone distribution (supply-based approach) and one based on the spatial distribution of individuals at risk (demand-based approach). In addition, hypothetical interventions to enhance the likelihood of witnessed overdoses in private or semiprivate settings were considered. Main Outcomes and Measures: Annual number of OODs and ratio of fatal to nonfatal opioid overdoses. Results: Modeling results indicated that distributing more naloxone supported by the state's opioid settlement could reduce OODs by 6.3% (95% simulation interval [SI], 0.3%-13.7%) and 8.8% (95% SI, 1.8%-17.5%) in 2025 with the supply-based and demand-based approaches, respectively. However, increasing witnessed overdoses by 20% to 60% demonstrated greater potential for reducing OODs, ranging from 8.5% (95% SI, 0.0%-20.3%) to 24.1% (95% SI, 8.6%-39.3%). Notably, synergistic associations were observed when combining both interventions: increased naloxone distribution with the 2 approaches and a 60% increase in witnessed overdoses could reduce OODs in 2025 by 33.5% (95% SI, 17.1%-50.4%) and 37.4% (95% SI, 19.6%-56.3%), respectively. Conclusions and Relevance: These findings suggest that interventions to address solitary drug use are needed to maximize the impact of continued efforts to increase community-based naloxone distribution, which may be particularly important for jurisdictions that have strong community-based naloxone distribution programs.