A Randomized Trial Evaluating Acceptance and Commitment Therapy and Smart Phone Care Management Application to Augment Buprenorphine Therapy for Opioid Use and Chronic Pain.

There is high comorbidity of opioid use disorder (OUD) and chronic pain (CP), which is often addressed by prescribing buprenorphine (BUP). While BUP is effective in preventing overdose, it does not address the psychological aspects of OUD and CP comorbidity and treatment retention rates are as low as 50%. The Virtual Opioid use disorder Integrated Chronic Pain Treatment (VOICE) study (NCT05039554) is a novel effectiveness-implementation trial to test a 12-week virtual group Acceptance and Commitment Therapy (ACT) protocol and a care management smartphone application (app; Valera Health) on pain and opioid use in patients with OUD and CP receiving BUP. Using a 2 × 2 factorial design, participants (expected N = 280) are randomized into: ACT, Valera app, ACT + Valera, or Treatment as Usual arm. This study is taking place in the Bronx, NY, a racially/ethnically diverse community that faces numerous socioeconomic stressors and is one of the nation's epicenters of the opioid epidemic. We created a culturally responsive ACT group protocol, and Valera psychoeducational material. Outcome measures include NIH HEAL Common Data Elements and ACT and Valera-specific measures. We are conducting a novel 2 × 2 trial investigating augmenting BUP treatment with ACT and Valera, with the goal that improved mental health and access to care will result in decreased and opioid use and pain interference.

Yoga and Physical Therapy for Chronic Pain and Opioid Use Disorder Onsite in an Opioid Treatment Program: A Randomized Controlled Trial.

BACKGROUND: There is a lack of integrated treatment for chronic pain and opioid use disorder (OUD). Yoga and physical therapy (PT) may improve pain and physical function of people living with (PLW) chronic low back pain (CLBP) and may also reduce opioid craving and use, but PLW with OUD face barriers to accessing these interventions. We hypothesize that compared to treatment as usual (TAU), providing yoga and PT onsite at opioid treatment programs (OTPs) will be effective at improving pain, opioid use, and quality of life among people with CLBP and OUD, and will be cost-effective. METHODS: In this hybrid type-1 effectiveness-implementation study, we will randomly assign 345 PLW CLBP and OUD from OTPs in the Bronx, NY, to 12 weeks of onsite yoga, onsite PT, or TAU. Primary outcomes are pain intensity, opioid use, and cost-effectiveness. Secondary outcomes include physical function and overall well-being. DISCUSSION: This trial tests an innovative, patient-centered approach to combined management for pain and OUD in real-world settings. We rigorously examine the efficacy of yoga and PT onsite at OTPs as nonpharmacologic, cost-effective treatments among people with CLBP and OUD who face barriers to integrated care.

Low-Dose Buprenorphine Initiation for Hospitalized Patients With Chronic Pain and Opioid Use Disorder or Opioid Misuse: Protocol for an Open-Label, Parallel-Group, Effectiveness-Implementation Randomized Controlled Trial.

Buprenorphine is an effective medication for both opioid use disorder (OUD) and chronic pain (CP), but transitioning from full opioid agonists to buprenorphine, a partial opioid agonist, can be challenging. Preliminary studies suggest that low-dose buprenorphine initiation can overcome some challenges in starting treatment, but no randomized controlled trials have compared low-dose and standard buprenorphine initiation approaches regarding effectiveness and safety or examined implementation in hospital settings. In a pragmatic open-label hybrid type I effectiveness-implementation trial based in a single urban health system, 270 hospitalized patients with (a) CP and (b) OUD or opioid misuse are being randomized to buprenorphine treatment initiation using 5-day low-dose or standard initiation protocols. Outcomes include buprenorphine treatment uptake (primary), defined as receiving buprenorphine treatment 7 days after enrollment, and other OUD and pain outcomes at 1-, 3-, and 6-month follow-up (secondary). Data collection will also include safety measures, implementation of low-dose initiation protocols, patient acceptability, and cost-effectiveness. Comparing strategies in a randomized clinical trial will provide the most definitive data to date regarding the effectiveness and safety of low-dose buprenorphine initiation. The study will also provide important data on treating CP at a time that clinical guidelines are evolving to center buprenorphine as a preferred opioid for CP.

Medicaid-Covered Peer Support Services Used by Enrollees With Opioid Use Disorder.

This cross-sectional study provides a multistate description of utilization of Medicaid-covered peer support services in 2019 by enrollees with opioid use disorder (OUD).

Dangerous Variation or Patient-Centered Care? Palliative Care and Pain Providers' Comfort, Experiences, and Approaches when Treating Cancer Pain With Coexisting Aberrant Behaviors.

BACKGROUND: Patients with cancer-related pain are at high risk for aberrant drug use behaviors (ADB), including self-escalation, diversion and concurrent illicit substance or opioid misuse; however, limited evidence is available to guide opioid prescribing for patients with life-limiting illness and concurrent or suspected ADB. We sought to characterize how specialists evaluate for and manage these high-risk behaviors in patients with cancer-related pain. METHODS: We conducted telephonic semi-structured interviews with palliative care and pain medicine providers. Participants discussed their own comfort and experience level with identifying and managing ADB in patients with life-limiting illness. They were subsequently presented with a series of standardized scenarios and asked to describe their concerns and management strategies. RESULTS: 95 interdisciplinary pain and palliative care specialists were contacted; 37 agreed to participate (38.9%). Analysis of interview contents revealed several central themes: (1) widespread discomfort and anxiety regarding safe and compassionate opioid prescribing for high-risk patients, (2) belief that widely used risk-mitigation tools such as opioid contracts and urine drug screens provided inadequate support for decision-making, and (3) lack of institutional and organizational support and guidance for safe prescribing strategies. Most clinicians reported self-education regarding addiction and alternative prescribing/pain management strategies. Providers varied widely in their willingness to discontinue opioid prescribing in a patient with aberrant behavior and pain associated with life-limiting illness. CONCLUSION: Providers caring for patients demonstrating ADB and cancer-related pain struggle to balance safe prescribing with symptom management. Increased guidance is needed regarding opioid prescribing, monitoring, and discontinuation in high-risk patients.

Association between claims-based setting of diagnosis and treatment initiation among Medicare patients with hepatitis C.

OBJECTIVE: To develop a claims-based algorithm to determine the setting of a disease diagnosis. DATA SOURCES AND STUDY SETTING: Medicare enrollment and claims data from 2014 to 2019. STUDY DESIGN: We developed a claims-based algorithm using facility indicators, revenue center codes, and place of service codes to identify settings where HCV diagnosis first appeared. When the first appearance was in a laboratory, we attempted to associate HCV diagnoses with subsequent clinical visits. Face validity was assessed by examining association of claims-based diagnostic settings with treatment initiation. DATA COLLECTION/EXTRACTION METHODS: Patients newly diagnosed with HCV and continuously enrolled in traditional Medicare Parts A, B, and D (12 months before and 6 months after index diagnosis) were included. PRINCIPAL FINDINGS: Among 104,454 patients aged 18-64 and 66,726 aged ≥65, 70.1% and 69%, respectively, were diagnosed in outpatient settings, and 20.2% and 22.7%, respectively in laboratory or unknown settings. Logistic regression revealed significantly lower odds of treatment initiation after diagnosis in emergency departments/urgent cares, hospitals, laboratories, or unclassified settings, than in outpatient visits. CONCLUSIONS: The algorithm identified the setting of HCV diagnosis in most cases, and found significant associations with treatment initiation, suggesting an approach that can be adapted for future claims-based studies.

Detection of Personal and Family History of Suicidal Thoughts and Behaviors using Deep Learning and Natural Language Processing: A Multi-Site Study.

Objective: Personal and family history of suicidal thoughts and behaviors (PSH and FSH, respectively) are significant risk factors associated with future suicide events. These are often captured in narrative clinical notes in electronic health records (EHRs). Collaboratively, Weill Cornell Medicine (WCM), Northwestern Medicine (NM), and the University of Florida (UF) developed and validated deep learning (DL)-based natural language processing (NLP) tools to detect PSH and FSH from such notes. The tool's performance was further benchmarked against a method relying exclusively on ICD-9/10 diagnosis codes. Materials and Methods: We developed DL-based NLP tools utilizing pre-trained transformer models Bio_ClinicalBERT and GatorTron, and compared them with expert-informed, rule-based methods. The tools were initially developed and validated using manually annotated clinical notes at WCM. Their portability and performance were further evaluated using clinical notes at NM and UF. Results: The DL tools outperformed the rule-based NLP tool in identifying PSH and FHS. For detecting PSH, the rule-based system obtained an F1-score of 0.75 ± 0.07, while the Bio_ClinicalBERT and GatorTron DL tools scored 0.83 ± 0.09 and 0.84 ± 0.07, respectively. For detecting FSH, the rule-based NLP tool's F1-score was 0.69 ± 0.11, compared to 0.89 ± 0.10 for Bio_ClinicalBERT and 0.92 ± 0.07 for GatorTron. For the gold standard corpora across the three sites, only 2.2% (WCM), 9.3% (NM), and 7.8% (UF) of patients reported to have an ICD-9/10 diagnosis code for suicidal thoughts and behaviors prior to the clinical notes report date. The best performing GatorTron DL tool identified 93.0% (WCM), 80.4% (NM), and 89.0% (UF) of patients with documented PSH, and 85.0%(WCM), 89.5%(NM), and 100%(UF) of patients with documented FSH in their notes. Discussion: While PSH and FSH are significant risk factors for future suicide events, little effort has been made previously to identify individuals with these history. To address this, we developed a transformer based DL method and compared with conventional rule-based NLP approach. The varying effectiveness of the rule-based tools across sites suggests a need for improvement in its dictionary-based approach. In contrast, the performances of the DL tools were higher and comparable across sites. Furthermore, DL tools were fine-tuned using only small number of annotated notes at each site, underscores its greater adaptability to local documentation practices and lexical variations. Conclusion: Variations in local documentation practices across health care systems pose challenges to rule-based NLP tools. In contrast, the developed DL tools can effectively extract PSH and FSH information from unstructured clinical notes. These tools will provide clinicians with crucial information for assessing and treating patients at elevated risk for suicide who are rarely been diagnosed.

Healthcare costs for legally adjudicated elder mistreatment victims in comparison to non-mistreated older adults.

BACKGROUND: Elder mistreatment (EM) is associated with adverse health outcomes and healthcare utilization patterns that differ from other older adults. However, the association of EM with healthcare costs has not been examined. Our goal was to compare healthcare costs between legally adjudicated EM victims and controls. METHODS: We used Medicare insurance claims to examine healthcare costs of EM victims in the 2 years surrounding initial mistreatment identification in comparison to matched controls. We adjusted costs using the Centers for Medicare and Medicaid Services Hierarchical Condition Categories (CMS-HCC) risk score. RESULTS: We examined healthcare costs in 114 individuals who experienced EM and 410 matched controls. Total Medicare Parts A and B healthcare costs were similar between cases and controls in the 12 months prior to initial EM detection ($11,673 vs. $11,402, p = 0.92), but cases had significantly higher total healthcare costs during the 12 months after initial mistreatment identification ($15,927 vs. $10,805, p = 0.04). Adjusting for CMS-HCC scores, cases had, in the 12 months after initial EM identification, $5084 of additional total healthcare costs (95% confidence interval [$92, $10,077], p = 0.046) and $5817 of additional acute/subacute/post-acute costs (95% confidence interval [$1271, $10,362], p = 0.012) compared with controls. The significantly higher total costs and acute/sub-acute/post-acute costs among EM victims in the post-year were concentrated in the 120 days after EM detection. CONCLUSIONS: Older adults experiencing EM had substantially higher total costs during the 12 months after mistreatment identification, driven by an increase in acute/sub-acute/post-acute costs and focused on the period immediately after initial EM detection.

Medicare coverage of buprenorphine-naloxone film surrounding generic entry.

OBJECTIVES: To investigate trends in Medicare coverage of buprenorphine-naloxone film before and after the FDA approval of its first generic versions. STUDY DESIGN: This study used data from the Part D Prescription Drug Plan Formulary, Pharmacy Network, and Pricing Information Files from 2015 to 2022, which provide information on all stand-alone Medicare/Medicare Advantage Prescription Drug Plans. METHODS: We examined the percentage of plans that provided coverage of brand-name and generic buprenorphine-naloxone films with strength 8 mg/2 mg during 2015-2022. Median out-of-pocket (OOP) cost for a 30-day supply was estimated among all plans that provided coverage. RESULTS: Generic buprenorphine-naloxone film was covered by 82% of Medicare Part D plans in 2020, 2 years after market entry. Coverage of brand-name Suboxone film decreased from 76% in 2019 to 42% in 2020. The median OOP cost of buprenorphine-naloxone films faced by Medicare enrollees decreased from $99 in 2019 to $42 in 2020, driven by the lower price of generic films. In contrast, the OOP cost for brand-name buprenorphine-naloxone film increased gradually from $85 in 2015 to $100 in 2022. CONCLUSIONS: Medicare Part D plan formularies replaced brand-name buprenorphine-naloxone films with the newly approved generic versions. This was accompanied by a substantial decrease in estimated OOP cost faced by Part D enrollees. These changes could potentially increase access to buprenorphine among Medicare enrollees with opioid use disorder.

Hepatitis C Treatment Initiation Among US Medicaid Enrollees.

Importance: Direct-acting antiviral (DAA) treatment for hepatitis C virus (HCV) infection is highly effective but remains underused. Understanding disparities in the delivery of DAAs is important for HCV elimination planning and designing interventions to promote equitable treatment. Objective: To examine variations in the receipt of DAA in the 6 months following a new HCV diagnosis. Design, Setting, and Participants: This retrospective cohort study used national Medicaid claims from 2017 to 2019 from 50 states, Washington DC, and Puerto Rico. Individuals aged 18 to 64 years with a new diagnosis of HCV in 2018 were included. A new diagnosis was defined as a claim for an HCV RNA test followed by an International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) diagnosis code, after a 1-year lookback period. Main Outcomes and Measures: Outcome was receipt of a DAA prescription within 6 months of diagnosis. Logistic regression was used to examine demographic factors and ICD-10-identified comorbidities associated with treatment initiation. Results: Among 87 652 individuals, 43 078 (49%) were females, 12 355 (14%) were age 18 to 29 years, 35 181 (40%) age 30 to 49, 51 282 (46%) were non-Hispanic White, and 48 840 (49%) had an injection drug use diagnosis. Of these individuals, 17 927 (20%) received DAAs within 6 months of their first HCV diagnosis. In the regression analyses, male sex was associated with increased treatment initiation (OR, 1.24; 95% CI, 1.16-1.33). Being age 18 to 29 years (OR, 0.65; 95% CI, 0.50-0.85) and injection drug use (OR, 0.84; 95% CI, 0.75-0.94) were associated with decreased treatment initiation. After adjustment for state fixed effects, Asian race (OR, 0.50; 95% CI, 0.40-0.64), American Indian or Alaska Native race (OR, 0.68; 95% CI, 0.55-0.84), and Hispanic ethnicity (OR, 0.81; 95% CI, 0.71-0.93) were associated with decreased treatment initiation. Adjustment for state Medicaid policy did not attenuate the racial or ethnic disparities. Conclusions: In this retrospective cohort study, HCV treatment initiation was low among Medicaid beneficiaries and varied by demographic characteristics and comorbidities. Interventions are needed to increase HCV treatment uptake among Medicaid beneficiaries and to address disparities in treatment among key populations, including younger individuals, females, individuals from minoritized racial and ethnic groups, and people who inject drugs.

Racial, Ethnic, and Sex Differences in Methadone-Involved Overdose Deaths Before and After the US Federal Policy Change Expanding Take-home Methadone Doses.

Importance: In March 2020, the Substance Abuse and Mental Health Services Administration (SAMHSA) permitted states to relax restrictions on take-home methadone doses for treatment-adherent patients to minimize COVID-19 exposures. Objective: To assess whether the methadone take-home policy change was associated with drug overdose deaths among different racial, ethnic, and sex groups. Design, Setting, and Participants: Interrupted time series analysis from January 1, 2018, to June 30, 2022. Data analysis was conducted from February 18, 2023, to February 28, 2023. In this population-based cohort study of drug overdose mortality including 14 529 methadone-involved deaths, monthly counts of methadone-involved drug overdose deaths were obtained for 6 demographic groups: Hispanic men and women, non-Hispanic Black men and women, and non-Hispanic White men and women. Exposure: On March 16, 2020, in response to the first wave of the COVID-19 pandemic, SAMHSA issued an exemption to the states that permitted up to 28 days of take-home methadone for stable patients and 14 days for less stable patients. Main Outcome Measures: Monthly methadone-involved overdose deaths. Results: From January 1, 2018, to June 30, 2022 (54 months), there were 14 529 methadone-involved deaths in the United States; 14 112 (97.1%) occurred in the study's 6 demographic groups (Black men, 1234; Black women, 754; Hispanic men, 1061; Hispanic women, 520; White men, 5991; and White women, 4552). Among Black men, there was a decrease in monthly methadone deaths associated with the March 2020 policy change (change of slope from the preintervention period, -0.55 [95% CI, -0.95 to -0.15]). Hispanic men also experienced a decrease in monthly methadone deaths associated with the policy change (-0.42 [95% CI, -0.68 to -0.17]). Among Black women, Hispanic women, White men, and White women, the policy change was not associated with a change in monthly methadone deaths (Black women, -0.27 [95% CI, -1.13 to 0.59]; Hispanic women, 0.29 [95% CI, -0.46 to 1.04]; White men, -0.08 [95% CI, -1.05 to 0.88]; and White women, -0.43 [95% CI, -1.26 to 0.40]). Conclusions and Relevance: In this interrupted time series study of monthly methadone-involved overdose deaths, the take-home policy may have helped reduce deaths for Black and Hispanic men but had no association with deaths of Black or Hispanic women or White men or women.

Clinics Optimizing MEthadone Take-homes for opioid use disorder (COMET): Protocol for a stepped-wedge randomized trial to facilitate clinic level changes.

INTRODUCTION: Regulatory changes made during the COVID-19 public health emergency (PHE) that relaxed criteria for take-home dosing (THD) of methadone offer an opportunity to improve quality of care with a lifesaving treatment. There is a pressing need for research to study the long-term effects of the new PHE THD rules and to test data-driven interventions to promote more effective adoption by opioid treatment programs (OTPs). We propose a two-phase project to develop and test a multidimensional intervention for OTPs that leverages information from large State administrative data. METHODS AND ANALYSIS: We propose a two-phased project to develop then test a multidimensional OTP intervention to address clinical decision making, regulatory confusion, legal liability concerns, capacity for clinical practice change, and financial barriers to THD. The intervention will include OTP THD specific dashboards drawn from multiple State databases. The approach will be informed by the Health Equity Implementation Framework (HEIF). In phase 1, we will employ an explanatory sequential mixed methods design to combine analysis of large state administrative databases-Medicaid, treatment registry, THD reporting-with qualitative interviews to develop and refine the intervention. In phase 2, we will conduct a stepped-wedge trial over three years with 36 OTPs randomized to 6 cohorts of a six-month clinic-level intervention. The trial will test intervention effects on OTP-level implementation outcomes and patient outcomes (1) THD use; 2) retention in care; and 3) adverse healthcare events). We will specifically examine intervention effects for Black and Latinx clients. A concurrent triangulation mixed methods design will be used: quantitative and qualitative data collection will occur concurrently and results will be integrated after analysis of each. We will employ generalized linear mixed models (GLMMs) in the analysis of stepped-wedge trials. The primary outcome will be weekly or greater THD. The semi-structured interviews will be transcribed and analyzed with Dedoose to identify key facilitators, barriers, and experiences according to HEIF constructs using directed content analysis. DISCUSSION: This multi-phase, embedded mixed methods project addresses a critical need to support long-term practice changes in methadone treatment for opioid use disorder following systemic changes emerging from the PHE-particularly for Black and Latinx individuals with opioid use disorder. By combining findings from analyses of large administrative data with lessons gleaned from qualitative interviews of OTPs that were flexible with THD and those that were not, we will build and test the intervention to coach clinics to increase flexibility with THD. The findings will inform policy at the local and national level.

Emergency Department and Hospital Utilization Among Older Adults Before and After Identification of Elder Mistreatment.

Importance: Elder mistreatment is common and has serious health consequences. Little is known, however, about patterns of health care utilization among older adults experiencing elder mistreatment. Objective: To examine emergency department (ED) and hospital utilization of older adults experiencing elder mistreatment in the period surrounding initial mistreatment identification compared with other older adults. Design, Setting, and Participants: This retrospective case-control study used Medicare insurance claims to examine older adults experiencing elder mistreatment initially identified between January 1, 2003, and December 31, 2012, and control participants matched on age, sex, race and ethnicity, and zip code. Statistical analysis was performed in April 2022. Main Outcomes and Measures: We used multiple measures of ED and hospital utilization patterns (eg, new and return visits, frequency, urgency, and hospitalizations) in the 12 months before and after mistreatment identification. Data were adjusted using US Centers for Medicare and Medicaid Services Hierarchical Condition Categories risk scores. Chi-squared tests and conditional logistic regression models were used for data analyses. Results: This study included 114 case patients and 410 control participants. Their median age was 72 years (IQR, 68-78 years), and 340 (64.9%) were women. Race and ethnicity were reported as racial or ethnic minority (114 [21.8%]), White (408 [77.9%]), or unknown (2 [0.4%]). During the 24 months surrounding identification of elder mistreatment, older adults experiencing mistreatment were more likely to have had an ED visit (77 [67.5%] vs 179 [43.7%]; adjusted odds ratio [AOR], 2.95 [95% CI, 1.78-4.91]; P < .001) and a hospitalization (44 [38.6%] vs 108 [26.3%]; AOR, 1.90 [95% CI, 1.13-3.21]; P = .02) compared with other older adults. In addition, multiple ED visits, at least 1 ED visit for injury, visits to multiple EDs, high-frequency ED use, return ED visits within 7 days, ED visits for low-urgency issues, multiple hospitalizations, at least 1 hospitalization for injury, hospitalization at multiple hospitals, and hospitalization for ambulatory care sensitive conditions were substantially more likely for individuals experiencing elder mistreatment. The rate of ED and hospital utilization for older adults experiencing elder mistreatment was much higher in the 12 months after identification than before, leading to more pronounced differences between case patients and control participants in postidentification utilization. During the 12 months after identification of elder mistreatment, older adults experiencing mistreatment were particularly more likely to have had high-frequency ED use (12 [10.5%] vs 8 [2.0%]; AOR, 8.23 [95% CI, 2.56-26.49]; P < .001) and to have visited the ED for low-urgency issues (12 [10.5%] vs 8 [2.0%]; AOR, 7.33 [95% CI, 2.54-21.18]; P < .001). Conclusions and Relevance: In this case-control study of health care utilization, older adults experiencing mistreatment used EDs and hospitals more frequently and with different patterns during the period surrounding mistreatment identification than other older adults. Additional research is needed to better characterize these patterns, which may be helpful in informing early identification, intervention, and prevention of elder mistreatment.

Medical Marijuana Legalization and Opioid- and Pain-Related Outcomes Among Patients Newly Diagnosed With Cancer Receiving Anticancer Treatment.

Importance: The past decade saw rapid declines in opioids dispensed to patients with active cancer, with a concurrent increase in marijuana use among cancer survivors possibly associated with state medical marijuana legalization. Objective: To assess the associations between medical marijuana legalization and opioid-related and pain-related outcomes for adult patients receiving cancer treatment. Design, Setting, and Participants: This cross-sectional study used 2012 to 2017 national commercial claims data and a difference-in-differences design to estimate the associations of interest for patients residing in 34 states without medical marijuana legalization by January 1, 2012. Secondary analysis differentiated between medical marijuana legalization with and without legal allowances for retail dispensaries. Data analysis was conducted between December 2021 and August 2022. Study samples included privately insured patients aged 18 to 64 years who received anticancer treatment during the 6 months after a new breast (in women), colorectal, or lung cancer diagnosis. Exposures: State medical marijuana legalization that took effect between 2012 and 2017. Main Outcomes and Measures: Having 1 or more days of opioids, 1 or more days of long-acting opioids, total morphine milligram equivalents of any opioid dispensed to patients with 1 or more opioid days, and 1 or more pain-related emergency department visits or hospitalizations (hereafter, hospital events) during the 6 months after a new cancer diagnosis. Interaction terms were included between each policy indicator and an indicator of recent opioids, defined as having 1 or more opioid prescriptions during the 12 months before the new cancer diagnosis. Logistic models were estimated for dichotomous outcomes, and generalized linear models were estimated for morphine milligram equivalents. Results: The analysis included 38 189 patients newly diagnosed with breast cancer (38 189 women [100%]), 12 816 with colorectal cancer (7100 men [55.4%]), and 7190 with lung cancer (3674 women [51.1%]). Medical marijuana legalization was associated with a reduction in the rate of 1 or more opioid days from 90.1% to 84.4% (difference, 5.6 [95% CI, 2.2-9.0] percentage points; P = .001) among patients with breast cancer with recent opioids, from 89.4% to 84.4% (difference, 4.9 [95% CI, 0.5-9.4] percentage points; P = .03) among patients with colorectal cancer with recent opioids, and from 33.8% to 27.2% (difference, 6.5 [95% CI, 1.2-11.9] percentage points; P = .02) among patients with lung cancer without recent opioids. Medical marijuana legalization was associated with a reduction in the rate of 1 or more pain-related hospital events from 19.3% to 13.0% (difference, 6.3 [95% CI, 0.7-12.0] percentage points; P = .03) among patients with lung cancer with recent opioids. Conclusions and Relevance: Findings of this cross-sectional study suggest that medical marijuana legalization implemented from 2012 to 2017 was associated with a lower rate of opioid dispensing and pain-related hospital events among some adults receiving treatment for newly diagnosed cancer. The nature of these associations and their implications for patient safety and quality of life need to be further investigated.

Predictive Modeling for Suicide-Related Outcomes and Risk Factors among Patients with Pain Conditions: A Systematic Review.

Suicide is a leading cause of death in the US. Patients with pain conditions have higher suicidal risks. In a systematic review searching observational studies from multiple sources (e.g., MEDLINE) from 1 January 2000-12 September 2020, we evaluated existing suicide prediction models' (SPMs) performance and identified risk factors and their derived data sources among patients with pain conditions. The suicide-related outcomes included suicidal ideation, suicide attempts, suicide deaths, and suicide behaviors. Among the 87 studies included (with 8 SPM studies), 107 suicide risk factors (grouped into 27 categories) were identified. The most frequently occurring risk factor category was depression and their severity (33%). Approximately 20% of the risk factor categories would require identification from data sources beyond structured data (e.g., clinical notes). For 8 SPM studies (only 2 performing validation), the reported prediction metrics/performance varied: C-statistics (n = 3 studies) ranged 0.67-0.84, overall accuracy(n = 5): 0.78-0.96, sensitivity(n = 2): 0.65-0.91, and positive predictive values(n = 3): 0.01-0.43. Using the modified Quality in Prognosis Studies tool to assess the risk of biases, four SPM studies had moderate-to-high risk of biases. This systematic review identified a comprehensive list of risk factors that may improve predicting suicidal risks for patients with pain conditions. Future studies need to examine reasons for performance variations and SPM's clinical utility.

Integrating peer support services into primary care-based OUD treatment: Lessons from the Penn integrated model.

Opioid use disorder (OUD) is a major public health emergency in the United States. In 2020, 2.7 million individuals had an OUD. Medication for opioid use disorder is the evidence-based, standard of care for treating OUD in outpatient settings, especially buprenorphine because it is effective and has low toxicity. Buprenorphine is increasingly prescribed in primary care, a setting that provides greater anonymity and convenience than substance use disorder treatment centers. Yet two-thirds of people who begin buprenorphine treatment discontinue within the first six months. Treatment dropout elevates the risks of return to use, infections, higher levels of medical care and related costs, justice system involvement, and death. One promising form of retention support is peer service programs. Peers combine their lived experience of substance use and recovery with formal training to help patients engage and persist in OUD treatment. They provide a range of services, including health education, encouragement and empathy, coping skills, recovery modeling, and concrete assistance in overcoming the situational barriers to retention. However, guidance is needed to define the peer role in primary care, the specific tasks peers should perform, the competencies those tasks require, training and professional development needs, and peer performance standards. Guidance also is needed to integrate peers into the care team, allocate and coordinate responsibilities among care team members, manage peer operations and workflow, and facilitate effective team communication. Here we describe a peer support program in the University of Pennsylvania Health System (UPHS or Penn Medicine) network of primary care practices. This paper details the program's core components, values, and activities. We also report the organizational challenges, unresolved questions, and lessons for the field in administering a peer support program to meet the needs of patients served by a large, urban medical system with an extensive suburban and rural catchment area. CLINICAL TRIALS REGISTRATION: www.clinicaltrials.gov registration: NCT04245423.

Medicare Part D Coverage Restrictions and Patient Cost-Sharing for Opioids Commonly Used for Cancer Pain, 2015-2021.

PURPOSE: Nation-wide rapid declines in prescription opioid dispensing gave rise to concerns regarding restricted access to effective pain management for patients with cancer-related pain. One important mechanism for such restrictions could be through more restrictive insurance coverage for opioids. This study aims to assess recent changes in Medicare Part D formulary designs for opioids commonly used for cancer-related pain. METHODS: We used data from the 2015-2021 Medicare Prescription Drug Plan (PDP) Formulary Files to assess formulary changes for six opioid-dose combinations commonly used for cancer-related pain. We estimated % of PDPs adopting prior authorization, quantity limits (and limits adopted), and a higher cost-sharing tier for each opioid-dose combination. We further estimated median and mean out-of-pocket (OOP) costs across all PDPs for a 30-day supply of the drug. Trends in proportions were tested using the Cochrane-Armitage test; trends in continuous measures were tested using the Jonckheere-Terpstra test. RESULTS: Proportion of PDPs adopting prior authorization increased from close to 0% to about 50% for two long-acting opioids (P < .001). Distribution of quantity limits across PDPs shifted over time to being more restrictive for all opioids considered (P < .001). For four of the six opioids, the proportion of PDPs adopting tier 3 or above increased from below or about 50% to well over 70% (P < .001). For the same four opioids, median OOP costs doubled to quadrupled (P < .001). CONCLUSION: Medicare PDP coverage has become increasingly restrictive for opioids commonly used for cancer-related pain, with multifold increases in patient OOP costs over the past 7 years. These changes pose concerns for patients with cancer needing opioid therapies for pain control and call for strategies to effectively exempt cancer-related pain from insurance and pharmacy rules intended to apply to opioids for noncancer chronic pain.

Medicaid Hepatitis C Virus Treatment Policies: Impact on Testing and Treatment in the Commercially Insured.

INTRODUCTION: A total of 23 state Medicaid programs continue to restrict hepatitis C virus (HCV) medication access by liver disease or substance-use criteria, creating obstacles to HCV elimination and significant care disparities. Because public insurers often set precedents for private insurer coverage and clinician practice patterns, this study sought to analyze whether spillover occurs from state Medicaid HCV treatment restrictions to HCV screening and treatment rates in commercially insured individuals. METHODS: Investigators analyzed 2014‒2017 commercial claims data across 48 U.S. states (721,961,965 person-months) and used an interrupted times series design to compare hepatitis C virus screening and treatment rates before and after state Medicaid HCV treatment policy changes, adjusting for state-level random effects, Medicaid expansion status, and state drug overdose incidence rates, in states that relaxed Medicaid policy over the study period. Analysis occurred during 2019‒2021. RESULTS: Hepatitis C virus screening rates among commercially insured individuals increased after the corresponding state Medicaid program relaxed HCV treatment policy. Among states that changed Medicaid policy, those that reduced fibrosis or both fibrosis and abstinence restrictions experienced increased HCV screening rates by the study end compared with states that changed only abstinence restrictions (rate ratio=1.29; 95% CI=1.15, 1.44; and rate ratio=1.32; 95% CI=1.17, 1.50, respectively). Similar patterns did not occur in HCV treatment rates, which declined after 2015 across groups. CONCLUSIONS: These data show that HCV screening rates increased among commercially insured individuals after the removal of Medicaid HCV treatment restrictions in the same state. This suggests that Medicaid treatment policies can spill over to affect health outcomes among commercially insured populations.