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Background: Given the continued rise in opioid-related overdoses, many states have expanded access to the opioid antagonist naloxone. We sought to provide comprehensive data on one such strategy: the authority of providers at different emergency medical services (EMS) licensure levels to administer naloxone., Methods: We conducted a systematic legal review of state laws and protocols governing the authority of different EMS licensure levels to administer naloxone. We used Westlaw, state government websites and scope of practice protocols. We coded relevant policies regarding which, if any, administration routes and dosages of naloxone are permitted for each licensure level: emergency medical responder (EMR), emergency medical technician (EMT), advanced emergency medical technician (AEMT), and paramedic., Results: As of July 2020, all states with relevant laws or protocols authorize paramedics, AEMTs, and EMTs to administer naloxone. Thirty-nine states with an EMR licensure level and statewide protocol authorize naloxone administration by EMRs, up from only two in 2013. Permissible routes of administration have increased across all EMS provider levels, providing advanced life support providers (i.e., paramedics and AEMTs) with expanded discretion; however, authorization for intravenous and intramuscular administration remains relatively uncommon for basic life support (BLS) providers. When specified, maximum doses authorized ranged widely, from 2.0 to 12.0 milligrams., Conclusions: Naloxone administration authority is now widely granted to EMS providers. Most states allow all licensed EMS provider levels to administer naloxone, a substantial increase for EMRs and EMTs since 2013. Paramedics and AEMTs have the greatest authority to select the dosage and route of administration., (Copyright © 2022. Published by Elsevier B.V.)

Background: Medications for opioid use disorder (MOUDs), including methadone, buprenorphine, and naltrexone, decrease mortality and morbidity for people with opioid use disorder (OUD). Buprenorphine and methadone have the strongest evidence base among MOUDs. Unlike methadone, buprenorphine may be prescribed in office-based settings in the U.S., including by nurse practitioners (NPs) and physician assistants (PAs) who have a federal waiver and adhere to federal patient limits. Buprenorphine is underutilized nationally, particularly in rural areas, and NPs/PAs could help address this gap. Therefore, we sought to identify perceptions of buprenorphine efficacy and perceptions of prescribing barriers among NPs/PAs. We also sought to compare perceived buprenorphine efficacy and perceived prescribing barriers between waivered and non-waivered NPs/PAs, as well as to compare perceived buprenorphine efficacy to perceived naltrexone and methadone efficacy., Methods: We disseminated an online survey to a random national sample of NPs/PAs. We used Mann-Whitney U tests to compare between waivered and non-waivered respondents. We used non-parametric Friedman tests and post-hoc Wilcoxon signed-rank tests to compare perceptions of medication types., Results: 240 respondents participated (6.5% response rate). Most respondents agreed buprenorphine is efficacious and believed counseling and peer support should complement buprenorphine. Buprenorphine was generally perceived as more efficacious than both naltrexone and methadone. Perceived buprenorphine efficacy and prescribing barriers differed by waiver status. Non-waivered practitioners were more likely than waivered practitioners to have concerns about buprenorphine affecting patient mix. Among waivered NPs/PAs, key buprenorphine prescribing barriers were insurance prior authorization and detoxification access., Conclusions: Our results suggest that different policies should target perceived barriers affecting waivered versus non-waivered NPs/PAs. Concerns about patient mix suggest stigmatization of patients with OUD. NP/PA education is needed about comparative medication efficaciousness, particularly regarding methadone. Even though many buprenorphine treatment patients benefits from counseling and/or peer support groups, NPs/PAs should be informed that such psychosocial treatment methods are not necessary for all buprenorphine patients., (© 2022. The Author(s).)

Background: Cannabis policy liberalization has increased cannabis availability for medical or recreational purposes. Up-to-date trends in medical cannabis licensure can inform clinical policy and care., Objective: To describe recent trends in medical cannabis licensure in the United States., Design: Ecological study with repeated measures., Setting: State registry data via state reports and data requests on medical cannabis licensure from 2016 to 2020., Participants: Medical cannabis patients (persons with medical cannabis licenses) in the United States., Measurements: Total patient volume, patients per 10 000 of total population, and patient-reported qualifying conditions (that is, symptoms or conditions qualifying patients for licensure)-including whether these symptoms align with current therapeutic evidence of cannabis-cannabinoid efficacy., Results: In 2020, 26 states and Washington, DC reported patient numbers, and 19 states reported patient-reported qualifying conditions. Total enrolled patients increased approximately 4.5-fold from 678 408 in 2016 to 2 974 433 in 2020. Patients per 10 000 total population generally increased from 2016 to 2020, most dramatically in Oklahoma (927.1 patients per 10 000 population). However, enrollment increased in states without recreational legalization (that is, medical-only states), whereas enrollment decreased in 5 of 7 with recreational legalization (that is, recreational states). In 2020, 68.2% of patient-reported qualifying conditions had substantial or conclusive evidence of therapeutic value versus 84.6% in 2016. Chronic pain was the most common patient-reported qualifying condition in 2020 (60.6%), followed by posttraumatic stress disorder (10.6%)., Limitation: Missing state data; lack of rationale for discontinuing medical cannabis licensure., Conclusion: Enrollment in medical cannabis programs approximately increased 4.5-fold from 2016 to 2020, although enrollment decreased in recreational states. Use for conditions or symptoms without a strong evidence basis increased from 15.4% (2016) to 31.8% (2020). Thoughtful regulatory and clinical strategies are needed to effectively manage this rapidly changing landscape., Primary Funding Source: National Institute on Drug Abuse of the National Institutes of Health.

Objective: To evaluate whether pain management clinic laws and prescription drug monitoring program (PDMP) prescriber check mandates, two state opioid policies with relatively rapid adoption across states, reduced opioid dispensing more or less in Black versus White patients., Data Sources: Pharmacy claims data, US sample of commercially insured adults, 2007-2018., Study Design: Stratifying by race, we used generalized estimating equations with an event-study specification to estimate time-varying effects of each policy on opioid dispensing, comparing to the four pre-policy quarters and states without the policy. Outcomes included high-dosage opioids, overlapping opioid prescriptions, concurrent opioid/benzodiazepines, opioids from >3 prescribers, opioids from >3 pharmacies., Data Extraction Methods: We identified all prescription opioid dispensing to Black and White adults aged 18-64 without a palliative care or cancer diagnosis code., Principal Findings: Exactly 7,096,592 White and 1,167,310 Black individuals met inclusion criteria. Pain management clinic laws were associated with reductions in two outcomes; their association with high-dosage receipt was larger among White patients. In contrast, reductions due to PDMP mandates appeared limited to, or larger in, Black patients compared with White patients in four of five outcomes. For example, PDMP mandates reduced high-dosage receipt in Black patients by 0.7 percentage points (95% CI: 0.36-1.08 ppt.) over 4 years: an 8.4% decrease from baseline; there was no apparent effect in White patients. Similarly, while there was limited evidence that mandates reduced overlapping opioid receipt in White patients, they appeared to reduce overlapping opioid receipt in Black patients by 1.3 ppt. (95% CI: -1.66--1.01 ppt.) across post-policy years-a 14.4% decrease from baseline., Conclusions: PDMP prescriber check mandates but not pain management clinic laws appeared to reduce opioid dispensing more in Black patients than White patients. Future research should discern the mechanisms underlying these disparities and their consequences for pain management., (© 2022 Health Research and Educational Trust.)

Context: Opioid prescribing to cancer patients is declining, but it is unknown whether reductions have been tailored to those at highest risk of opioid-related harms., Objectives: Examine whether declines in opioid dispensing to patients receiving active cancer treatment are sharper in patients with substance use disorder (SUD) or mental health diagnoses., Methods: We used 2008-2018 national, commercial healthcare claims data to examine adjusted and unadjusted trends in opioid dispensing (receipt of ≥1 fill; average daily dosage; receipt of high-dose opioids; receipt of concurrent opioids and benzodiazepines) to patients ages ≥18 receiving treatment for one of four cancer types (breast; colorectal; head and neck; sarcoma; N = 324,789 patients). To compare declines across subgroups with varying risk of opioid-related harms, we stratified by SUD and mental health diagnosis. To address potential confounding, we estimated subgroup-specific trends using generalized estimating equations, adjusting for covariates., Results: Across groups, rate of ≥1 opioid fill per quarter fell 32.5% (95% CI: 31.8%-33.2%) from 2008 to 2018; daily dose among those receiving opioids fell 37.6% (95% CI: 36.7%-38.6%). In most cases, these declines were not sharper in subgroups at greater risk of opioid-related harms. For example, patients with opioid use disorder experienced the smallest declines in dispensing frequency, and there was no evidence that declines were sharper in patients with mental health diagnoses., Conclusion: Sharp declines in opioid prescribing during the drug overdose crisis have affected a wide range of patients undergoing cancer treatment and may not have been sufficiently tailored to patient characteristics. Research on implications for opioid-related harms and pain management is needed., (Copyright © 2021 American Academy of Hospice and Palliative Medicine. All rights reserved.)

The Centers for Disease Control and Prevention's 2016 Guideline for Prescribing Opioids for Chronic Pain aimed to reduce unsafe opioid prescribing. It is unknown whether the guideline influenced prescribing in the target population: patients with chronic, noncancer pain, who may be at particular risk for opioid-related harms. To study this question, we used 2014-18 data from a commercial claims database to examine associations between the release of the guideline and opioid dispensing in a national cohort of more than 450,000 patients with four common chronic pain diagnoses. We also examined whether any reductions associated with the guideline were larger for diagnoses for which there existed stronger expert consensus against opioid prescribing. Overall, the guideline was associated with substantial reductions in dispensing opioids, including a reduction in patients' rate of receiving at least one opioid prescription by approximately 20 percentage points by December 2018 compared with the counterfactual, no-guideline scenario. However, the reductions in dispensing did not vary by the strength of expert consensus against opioid prescribing. These findings suggest that although voluntary guidelines can drive changes in prescribing, questions remain about how clinicians are tailoring opioid reductions to best benefit patients.

Background : Limited research has examined how states have changed policies for treatment of substance use disorder (SUD) during the COVID-19 pandemic. Objectives : We aimed to identify themes in state policy responses to the pandemic in the context of SUD treatment. Identifying themes in policy responses provides a framework for subsequent evaluations of the relationship between state policies and health service utilization. Methods : Between May and June 2020, we searched all Single State Agencies for Substance Abuse Services (SSA) websites for statements of SUD treatment policy responses to the pandemic. We conducted Iterative Categorization of policies for outpatient programs, opioid treatment programs, and other treatment settings to identify themes in policy responses. Results : We collected 220 documents from SSA websites from 45 states and Washington D.C. Eight specific themes emerged from our content analysis: delivery of pharmacological and non-pharmacological services, obtaining informed consent and documentation for remote services, conducting health assessments, facility operating procedures and staffing requirements, and permissible telehealth technology and billing protocols. Policy changes often mirrored federal guidance, for instance, by expanding methadone take-home options for opioid treatment programs. The extent and nature of policy changes varied across jurisdictions, including telehealth technology requirements and staffing flexibility. Conclusion : States have made significant policy changes to SUD treatment policies during COVID-19, particularly regarding telehealth and facilitation of remote care. Understanding these changes could help policymakers prioritize guidance during the pandemic and for future health crises. Impacts of policies on disparate treatment populations, including those with limited technological access, should be considered.

Importance: Suicide deaths are a leading cause of maternal mortality in the US, yet the prevalence and trends in suicidality (suicidal ideation and/or intentional self-harm) among childbearing individuals remain poorly described., Objective: To characterize trends in suicidality among childbearing individuals., Design, Setting, and Participants: This serial cross-sectional study analyzed data from a medical claims database for a large commercially insured population in the US from January 2006 to December 2017. There were 2714 diagnoses of suicidality 1 year before or after 698 239 deliveries among 595 237 individuals aged 15 to 44 years who were continuously enrolled in a single commercial health insurance plan. Data were analyzed from October 2019 to September 2020., Main Outcomes and Measures: The primary outcome was diagnosis of suicidality in childbearing individuals 1 year before or after birth based on the identification of relevant International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) and ICD-10-CM diagnosis codes during at least 1 inpatient or 2 outpatient visits., Results: Of 595 237 included childbearing individuals, the mean (SD) age at delivery was 31.9 (6.4) years. A total of 40 568 individuals (6.8%) were Asian, 52 613 (8.6%) were Black, 73 172 (12.1%) were Hispanic, 369 501 (63.1%) were White, and 59 383 (9.5%) had unknown or missing race/ethnicity data. A total of 2683 individuals were diagnosed with suicidality 1 year before or after giving birth for a total of 2714 diagnoses. The prevalence of suicidal ideation increased from 0.1% per 100 individuals in 2006 to 0.5% per 100 individuals in 2017 (difference, 0.4%; SE, 0.03; P < .001). Intentional self-harm prevalence increased from 0.1% per 100 individuals in 2006 to 0.2% per 100 individuals in 2017 (difference, 0.1%; SE, 0.02; P < .001). Suicidality prevalence increased from 0.2% per 100 individuals in 2006 to 0.6% per 100 individuals in 2017 (difference, 0.4%; SE, 0.04; P < .001). Diagnoses of suicidality with comorbid depression or anxiety increased from 1.2% per 100 individuals in 2006 to 2.6% per 100 individuals in 2017 (difference, 1.4%; SE, 0.2; P < .001). Diagnoses of suicidality with comorbid bipolar or psychotic disorders increased from 6.9% per 100 individuals in 2006 to 16.9% per 100 individuals in 2017 (difference, 10.1%; SE, 0.2; P < .001). Non-Hispanic Black individuals, individuals with lower income, and younger individuals experienced larger increases in suicidality over the study period., Conclusions and Relevance: In this cross-sectional study of US childbearing individuals, the prevalence of suicidal ideation and intentional self-harm occurring in the year preceding or following birth increased substantially over a 12-year period. Policy makers, health plans, and clinicians should ensure access to universal suicidality screening and appropriate treatment for pregnant and postpartum individuals and seek health system and policy avenues to mitigate this growing public health crisis, particularly for high-risk groups.

Background: Evidence demonstrates that medications for treating opioid use disorder (MOUD) -namely buprenorphine, methadone, and extended-release naltrexone-are effective at treating opioid use disorder (OUD) and reducing associated harms. However, MOUDs are heavily underutilized, largely due to the under-supply of providers trained and willing to prescribe the medications., Methods: To understand comparative beliefs about MOUD and barriers to MOUD, we conducted a mixed-methods study that involved focus group interviews and an online survey disseminated to a random group of licensed U.S. physicians, which oversampled physicians with a preexisting waiver to prescribe buprenorphine. Focus group results were analyzed using thematic analysis. Survey results were analyzed using descriptive and inferential statistical methods., Results: Study findings suggest that physicians have higher perceptions of efficacy for methadone and buprenorphine than for extended-release naltrexone, including for patients with co-occurring mental health disorders. Insurance obstacles, such as prior authorization requirements, were the most commonly cited barrier to prescribing buprenorphine and extended-release naltrexone. Regulatory barriers, such as the training required to obtain a federal waiver to prescribe buprenorphine, were not considered significant barriers by many physicians to prescribing buprenorphine and naltrexone in office-based settings. Nor did physicians perceive diversion to be a prominent barrier to prescribing buprenorphine. In focus groups, physicians identified financial, logistical, and workforce barriers-such as a lack of addiction treatment specialists-as additional barriers to prescribing medications to treat OUD., Conclusions: Additional education is needed for physicians regarding the comparative efficacy of different OUD medications. Governmental policies should mandate full insurance coverage of and prohibit prior authorization requirements for OUD medications.

Over the past decades, anti-cancer treatments have evolved rapidly from cytotoxic chemotherapies to targeted therapies including oral targeted medications and injectable immuno-oncology and cell therapies. New anti-cancer medications come to markets at increasingly high prices, and health insurance coverage is crucial for patient access to these therapies. State laws are intended to facilitate insurance coverage of anti-cancer therapies.Using Massachusetts as a case study, we identified five current cancer coverage state laws and interviewed experts on their perceptions of the relevance of the laws and how well they meet the current needs of cancer care given rapid changes in therapies. Interviewees emphasized that cancer therapies, as compared to many other therapeutic areas, are unique because insurance legislation targets their coverage. They identified the oral chemotherapy parity law as contributing to increasing treatment costs in commercial insurance. For commercial insurers, coverage mandates combined with the realities of new cancer medications - including high prices and often limited evidence of efficacy at approval - compound a difficult situation. Respondents recommended policy approaches to address this challenging coverage environment, including the implementation of closed formularies, the use of cost-effectiveness studies to guide coverage decisions, and the application of value-based pricing concepts. Given the evolution of cancer therapeutics, it may be time to evaluate the benefits and challenges of cancer coverage mandates.

Background: Since 2010, heroin-related overdoses have risen sharply, coinciding with policies to restrict access to prescription opioids. It is unknown if patients tapered or discontinued off prescription opioids transitioned to riskier heroin use. This study examined opioid prescribing, including long-term opioid therapy (LTOT) and discontinuation, prior to heroin overdose., Methods: We used retrospective longitudinal data from a national claims database to identify adults with an emergency or inpatient claim for heroin overdose between January 2010 and June 2017. Receipt of opioid prescription, LTOT episodes, and discontinuation of LTOT were measured for the period of one year prior to heroin overdose., Results: We identified 3183 individuals (53.2% age 18-25; 70.0% male) with a heroin overdose (incidence rate 4.20 per 100k person years). Nearly half (42.3%) received an opioid prescription in the prior 12 months, and 10.9% had an active opioid prescription in the week prior to overdose. LTOT at any time in the 12 months prior to overdose was uncommon (12.8%) among those with heroin overdoses, especially among individuals 18-25 years old (3.5%, P < 0.001). LTOT discontinuation prior to overdose was also relatively uncommon, experienced by 6.7% of individuals aged 46 and over and 2.5% of individuals aged 18-25 years (P < 0.001)., Conclusions: Prior to heroin overdose, prescription opioid use was common, but LTOT discontinuation was uncommon and observed primarily in older individuals with the lowest heroin overdose rates. Further study is needed to determine if these prescribing patterns are associated with increased heroin overdose., Competing Interests: Declaration of competing interest An author who is a CDC employee (KZ) was involved in the design and analysis. Experts on CDC subject matter provided feedback for accuracy and clarity but were not otherwise involved in the study., (Published by Elsevier B.V.)

Introduction: Prescription opioid use and driving is a public health concern given the risks associated with drugged driving, but the issue remains under-studied. We examined the prevalence and correlates of driving after taking prescription opioids (DAPO) among adults seeking emergency department (ED) treatment., Methods: Participants (aged 25-60) seeking ED care at a Level I trauma center completed a computerized survey. Validated instruments measured prescription opioid use, driving behaviors, and risky driving. Patients who reported past three-month prescription opioid use and drove at least twice weekly were administered an extended study survey measuring DAPO, depression, pain, and substance use., Results: Among participants completing the screening survey (n = 756; mean age = 42.8 [standard deviation {SD} =10.4]), 37.8% reported past three-month prescription opioid use (30.8% of whom used daily), and 14.7% reported past three-month DAPO. Of screened participants, 22.5% (n = 170) were eligible for the extended study survey. Unadjusted analyses demonstrated that participants reporting DAPO were more likely to use opioids daily (51.1% vs 15.9%) and had higher rates of opioid misuse (mean Current Opioid Misuse Measure score 3.4 [SD = 3.8] vs 1.1 [SD = 2.1]) chronic pain (80.7% vs 42.7%), and driving after marijuana or alcohol use (mean intoxicated driving score 2.1 [SD = 1.3] vs 0.3 [SD = 0.8]) compared to patients not reporting DAPO (all p<0.001). Adjusting for age, gender, employment, and insurance in a logistic regression model, participants reporting DAPO were more likely to report a chronic pain diagnosis (odds ratio [OR] = 3.77, 95% confidence interval [CI], 1.55-9.17), daily opioid use (OR = 3.81, 95% CI, 1.64-8.85), and higher levels of intoxicated driving (OR = 1.62, 95% CI, 1.07-2.45). Alcohol and marijuana use, depression, and opioid misuse were not associated with DAPO in adjusted analyses., Conclusion: Nearly one in six adult patients seeking ED care reported DAPO. The ED may be an important site for interventions addressing opioid-related drugged driving.

Opioid litigation continues a growing public health litigation trend in which governments seek to hold companies responsible for population harms related to their products. The litigation can serve to address gaps in regulatory and legislative policymaking and in market self-regulation pervasive in the prescription opioid domain. Moreover, prior opioid settlements have satisfied civil tort litigation objectives of obtaining compensation for injured parties, deterring harmful behavior, and holding certain opioid manufacturers, distributors and pharmacies accountable for their actions. In this way, opioid litigation represents progress over prior public health litigation campaigns involving tobacco, lead paint, and asbestos, which had more limited tort litigation effects. Although opioid litigation is not a comprehensive solution to the opioid crisis, it can complement other strategies and infuse much needed money, behavior changes, and public accountability for prescription opioid and related harms.

Importance: Benzodiazepines, which are associated with safety-related harms for older adults, were not covered when the US Medicare Part D prescription drug benefit began. Coverage was extended to benzodiazepines in 2013., Objective: To examine whether the expansion of benzodiazepine coverage among Medicare Advantage (MA) beneficiaries was associated with increases in fall-related injuries or overdoses among older adults., Design, Setting, and Participants: This ecological study used interrupted time-series with comparison-series analyses of MA claims data from 4 635 312 age-eligible MA beneficiaries and 940 629 commercially insured individuals (comparison group) stratified by age (65-69, 70-74, 75-79, and ≥80 years) to separately compare trends in fall-related injury and overdose before (January 1, 2010, to December 31, 2012) and after (January 1, 2013, to December 31, 2015) coverage expansion for benzodiazepines. Data analysis was performed from September 1, 2018, to August 31, 2019., Exposures: Expansion of benzodiazepine coverage in Medicare Part D in 2013., Main Outcomes and Measures: Monthly rate of fall-related injury and overdose., Results: In 2012 (the year before the policy change), women constituted 57.5% of the MA group and 47.4% of the comparison group. A total of 25.8% of individuals in the MA group were aged 65 to 69 years, and 29.3% were 80 years or older (mean [SD], 75.1 [6.4] years); 56.7% of individuals in the comparison group were aged 65 to 69 years, and 15.1% were 80 years or older (mean [SD] age, 70.9 [6.5] years). In the MA group, 4 635 312 individuals contributed 156 754 749 person-months from 2010 through 2015; in the comparison group, 940 629 individuals contributed 25 104 534 person-months. After coverage of benzodiazepines began, the rate (ie, slope) of fall-related injury among MA beneficiaries increased from before to after coverage among all age groups. Compared with the comparison group, the increase in rate was statistically significant for those 80 years or older (rate changes for the MA vs comparison groups: 0.12 [95% CI, 0.07 to 0.17] vs -0.01 [95% CI, -0.11 to 0.10]; P = .04 for interaction). The overdose trend changed from decreasing to increasing among MA beneficiaries after coverage for all age groups, with a statistically significant increase compared with the comparison group among those aged 65 to 69 years (rate changes for the MA vs comparison groups: 0.23 [95% CI, 0.17 to 0.30] vs 0.02 [95% CI, -0.06 to 0.11]; P < .001 for interaction) and among those 80 years or older (rate changes for the MA vs comparison groups: 0.07 [95% CI, 0.00 to 0.14] vs -0.20 [95% CI, -0.35 to -0.05]; P = .002 for interaction). Results among MA beneficiaries were consistent when stratified by sex and when limited to those prescribed opioids., Conclusions and Relevance: Medicare's expansion of benzodiazepine coverage may have been associated with increases in the rates of overdose among adults ages 65 to 69 years and in the rates of overdose and fall-related injury among those 80 years or older.

Background: The continued toll of opioid-related overdoses has motivated efforts to expand availability of naloxone to persons at high risk of overdose, with 2016 federal guidance encouraging clinicians to co-prescribe naloxone to patients with increased overdose risk. Some states have pursued analogous or stricter legal requirements that could more heavily influence prescriber behavior., Methods: We conducted a systematic legal review of state laws that mandate or recommend that healthcare providers prescribe naloxone to patients with indicators for opioid overdose risk. We coded relevant statutes and regulations for: applicable populations, patient criteria, educational requirements, and exemptions., Results: As of September 2019, 17 states had enacted naloxone co-prescribing laws, the earliest of which was implemented by Louisiana in January 2016. If patient overdose risk criteria are met, over half of these states mandate that providers prescribe naloxone (7 states, 41.1 %) or offer a naloxone prescription (2 states, 11.8 %); the remainder encourage prescribers to consider prescribing naloxone (8 states). Most states (58.8 %) define patient overdose risk based on opioid dosages prescribed, although the threshold varies substantially; other common overdose risk criteria include concomitant opioid and benzodiazepine prescriptions and patient history of substance use disorder or mental illness., Conclusions: A growing minority of states has adopted a naloxone prescribing law, although these policies remain less prevalent than other naloxone access laws. By targeting higher-risk patients during clinical encounters, naloxone prescribing requirements could increase naloxone prescribed, destigmatize naloxone use, and reduce overdose harms. Further investigation into policy effectiveness, unintended consequences, and appropriate parameters is warranted., Competing Interests: Declaration of Competing Interest None., (Published by Elsevier B.V.)

Policy Points This scoping review reveals a growing literature on the effects of certain state opioid misuse prevention policies, but persistent gaps in evidence on other prevalent state policies remain. Policymakers interested in reducing the volume and dosage of opioids prescribed and dispensed can consider adopting robust prescription drug monitoring programs with mandatory access provisions and drug supply management policies, such as prior authorization policies for high-risk prescription opioids. Further research should concentrate on potential unintended consequences of opioid misuse prevention policies, differential policy effects across populations, interventions that have not received sufficient evaluation (eg, Good Samaritan laws, naloxone access laws), and patient-related outcomes., Context: In the midst of an opioid crisis in the United States, an influx of state opioid misuse prevention policies has provided new opportunities to generate evidence of policy effectiveness that can inform policy decisions. We conducted a scoping review to synthesize the available evidence on the effectiveness of US state interventions to improve patient and provider outcomes related to opioid misuse and addiction., Methods: We searched six online databases to identify evaluations of state opioid policies. Eligible studies examined legislative and administrative policy interventions that evaluated (a) prescribing and dispensing, (b) patient behavior, or (c) patient health., Findings: Seventy-one articles met our inclusion criteria, including 41 studies published between 2016 and 2018. These articles evaluated nine types of state policies targeting opioid misuse. While prescription drug monitoring programs (PDMPs) have received considerable attention in the literature, far fewer studies addressed other types of state policy. Overall, evidence quality is very low for the majority of policies due to a small number of evaluations. Of interventions that have been the subject of considerable research, promising means of reducing the volume and dosages of opioids prescribed and dispensed include drug supply management policies and robust PDMPs. Due to low study number and quality, evidence is insufficient to draw conclusions regarding interventions targeting patient behavior and health outcomes, including naloxone access laws and Good Samaritan laws., Conclusions: Recent research has improved the evidence base on several state interventions targeting opioid misuse. Specifically, moderate evidence suggests that drug supply management policies and robust PDMPs reduce opioid prescribing. Despite the increase in rigorous evaluations, evidence remains limited for the majority of policies, particularly those targeting patient health-related outcomes., (© 2019 Milbank Memorial Fund.)

Importance: Since the Centers for Disease Control and Prevention published opioid prescribing guidelines in March 2016, 31 states have implemented legislation to restrict the duration of opioid prescriptions for acute pain. However, the association of these policies with the amount of opioid prescribed following surgery remains unknown., Objective: To examine the association of opioid prescribing duration limits with postoperative opioid prescribing in Massachusetts and Connecticut, the first 2 states to implement limits after March 2016., Design, Setting, and Participants: This interrupted time series analysis and cross-sectional study examined immediate level and slope changes in monthly outcomes after prescribing limit implementation in Massachusetts and Connecticut. These states implemented 7-day limits on initial opioid prescriptions on March 14, 2016, and July 1, 2016, respectively. Using the 2014 to 2017 IBM MarketScan Research Database, 16 281 opioid-naive adults in these states who filled a prescription within 3 days of surgery between July 1, 2014, and November 30, 2017, were identified. Data were analyzed from December 2018 to June 2019., Main Outcomes and Measures: The primary outcome was the prescription size in oral morphine equivalents (OMEs) for the initial postoperative opioid prescription (one 5/325 mg hydrocodone-acetaminophen pill = 5 OMEs). Secondary outcomes included days supplied in the initial prescription and the proportion of initial prescriptions exceeding a 7-day supply., Results: In total, 16 281 opioid-naive patients (9708 [59.6%] female; median [interquartile range] age range, 45-54 [35-44 to 55-64] years) undergoing surgical procedures were included. In Massachusetts, there were 5340 and 5435 patients in the preimplementation and postimplementation periods, respectively. In Connecticut, there were 2869 and 2637 patients in the preimplementation and postimplementation periods, respectively. Limit implementation in Massachusetts was associated with an immediate mean level decrease in prescription size (-38 OMEs [95% CI, -44 to -32 OMEs]) and with a mean decrease in slope (-1.5 OMEs/mo [95% CI, -2.1 to -0.9 OMEs/mo]). Implementation was also associated with an immediate mean level decrease in days supplied (-0.4 days [95% CI, -0.6 to -0.2 days]) and the proportion of prescriptions exceeding a 7-day supply (-5.9 percentage points [95% CI, -7.9 to -3.9 percentage points]). In contrast, limit implementation in Connecticut was not associated with level or slope changes in any outcome., Conclusions and Relevance: Opioid prescribing duration limits had a variable association with postoperative opioid prescribing in Massachusetts and Connecticut. The mean opioid prescription size filled, days supplied, and prescribing exceeding a 7-day supply decreased after limit implementation in Massachusetts only. Given the potential differences in policy dissemination and uptake, efforts to reduce opioid prescribing should also include surgeon education and evidence-based prescribing recommendations.

Stakeholders have implemented a multitude of system-level policies to address the U.S. opioid overdose epidemic. Because opioid prescribing partly fueled the crisis and because prescribing of medications for opioid addiction treatment is a key prevention strategy, it is critical to understand prescriber perceptions of policies in these domains. This article reviews prescriber awareness and opinions of the following system-level policies: opioid prescribing guidelines, prescription drug monitoring programs (PDMPs), medications for addiction treatment, and naloxone distribution programs. Most providers are aware of these policies, especially PDMPs, albeit a smaller proportion actively participate in their implementation. Low engagement in certain system-level policies is concerning and deserves attention, given that prescribers play an integral role in achieving optimal impact and mitigating the crisis., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Despite some improvements in access to evidence-based medications for opioid use disorder, treatment rates remain low at under a quarter of those with need. High costs for brand name products in these medication markets have limited the volume of drugs purchased, particularly through public health insurance and grant programs. Brand firm anti-competitive practices around the leading buprenorphine product Suboxone - including product hops, citizen petitions and Risk Evaluation and Mitigation Strategy abuses - helped to maintain high prices by extending brand exclusivity periods and hindering generic drug entry. Remedies to address costly anti-competitive activities include adoption of the proposed CREATES Act and modernization of the Hatch-Waxman Act by the Congress, and implementation of substantive modifications to the Food and Drug Administration citizen petition filing procedures. Given the persistence of these abuses, prescriptive changes are favorable to the procedural and clarifying steps thus far favored by the federal government. Extrapolating from the 37% price declines attributable to generic entry for buprenorphine tablets in 2011, our calculations suggest that implementing these remedies to facilitate generic competition with Suboxone film would have resulted in savings of approximately $703 million overall and $203 million to Medicaid in 2017.

Background: Any opioid-related hospitalization is an indicator of opioid-related harm and should ideally trigger carefully monitored decreases in opioid prescribing after inpatient stays in many, if not most, cases. However, past studies on opioid prescribing after hospitalizations have largely been limited to overdose related visits. It is unclear whether prescribing is different for other opioid-related indications such as opioid dependence and abuse and how that may compare with hospitalizations for overdose., Objective: To examine opioid-prescribing patterns before and after opioid-related hospitalizations for all opioid-related indications, not limited to overdose., Research Design: Retrospective cohort analysis of Veterans Health Administration (VHA) administrative claims from 2011 to 2014., Subjects: VHA patients who were hospitalized between fiscal years 2011 and 2014 and had at least 1 prescription opioid medication filled through the VHA pharmacy before their hospitalization., Measures: Opioid dispensing trajectories after hospitalization by opioid-related indication (ie, opioid dependence and/or abuse vs. overdose) compared with prescribing patterns for non-opioid-related hospitalizations., Results: Overall, opioid dosage dropped significantly (66% for dependence/abuse, 42% for overdose, and 3% for nonopioid diagnoses; P<0.001) across all 3 categories when comparing dose 57-63 days after admission to 57-63 days before hospitalization. However, 47% of the patients remained on the same dose or increased their opioid dose at 60 days after an opioid-related hospitalization. After adjusting for covariates, patients with a primary diagnosis of dependence/abuse had higher odds of having their dose discontinued compared with those with overdose: odds ratio (OR) 2.17 (1.19-3.96). Patients with admissions for opioid dependence and/or abuse had a statistically significant higher prevalence of depression, posttraumatic stress disorder, anxiety, and substance use disorders compared with those with an opioid overdose hospitalization., Conclusions: Opioid prescribing and patient risk factors before and after opioid-related hospitalizations vary by indication for hospitalization. To reduce costs and morbidity associated with opioid-related hospitalizations, opioid deintensification efforts need to be tailored to indication for hospitalization.

Importance: Opioid overdose deaths in the United States continue to increase, reflecting a growing need to treat those with opioid use disorder (OUD). Little is known about counties with high rates of opioid overdose mortality but low availability of OUD treatment., Objective: To identify characteristics of US counties with persistently high rates of opioid overdose mortality and low capacity to deliver OUD medications., Design, Setting, and Participants: In this cross-sectional study of data from 3142 US counties from January 1, 2015, to December 31, 2017, rates of opioid overdose mortality were compared with availability in 2017 of OUD medication providers (24 851 buprenorphine-waivered clinicians [physicians, nurse practitioners, and physician assistants], 1517 opioid treatment programs [providing methadone], and 5222 health care professionals who could prescribe extended-release naltrexone). Statistical analysis was performed from April 20, 2018, to May 8, 2019., Exposures: Demographic, workforce, lack of insurance, road density, urbanicity, opioid prescribing, and regional division county-level characteristics., Main Outcome and Measures: The outcome variable, "opioid high-risk county," was a binary indicator of a high (above national) rate of opioid overdose mortality with a low (below national) rate of provider availability to deliver OUD medication. Spatial logistic regression models were used to determine associations with being an opioid high-risk county., Results: Of 3142 counties, 751 (23.9%) had high rates of opioid overdose mortality. A total of 1457 counties (46.4%), and 946 of 1328 rural counties (71.2%), lacked a publicly available OUD medication provider in 2017. In adjusted models, compared with the West North Central division, counties in the East North Central, Mountain, and South Atlantic divisions had increased odds of being opioid high-risk counties (East North Central: odds ratio [OR], 2.21; 95% CI, 1.19-4.12; Mountain: OR, 4.15; 95% CI, 1.34-12.89; and South Atlantic: OR, 2.99; 95% CI, 1.26-7.11). A 1% increase in unemployment was associated with increased odds (OR, 1.09; 95% CI, 1.03-1.15) of a county being an opioid high-risk county. Counties with an additional 10 primary care clinicians per 100 000 population had a reduced risk of being opioid high-risk counties (OR, 0.89; 95% CI, 0.85-0.93), as did counties that were micropolitan (vs metropolitan) (OR, 0.67; 95% CI, 0.50-0.90) and those that had an additional 1% of the population younger than 25 years (OR, 0.95; 95% CI, 0.92-0.98)., Conclusions and Relevance: Counties with low availability of OUD medication providers and high rates of opioid overdose mortality were less likely to be micropolitan and have lower primary care clinician density, but were more likely to be in the East North Central, South Atlantic, or Mountain division and have higher rates of unemployment. Strategies to increase medication treatment must account for these factors.

Importance: Most prescription opioid misuse involves opioids prescribed to others-a form of opioid diversion. However, few indicators of diversion risk exist. Because family members can often access patients' opioids, one such indicator may be the frequency with which opioid prescriptions are filled by patients when their family members are engaged in opioid prescriber and pharmacy shopping ("doctor and pharmacy shopping"). To date, this frequency has not been estimated., Objective: To estimate the proportion of opioid prescription fills for which family members meet prescriber and pharmacy shopping criteria., Design, Setting, and Participants: A cross-sectional analysis of 2015-2016 claims from a national commercial insurer was conducted from August to October, 2018. The sample included patients without cancer who were covered by family insurance plans and had 1 or more opioid prescription fill in 2016, as measured by prescription drug claims. Fills were the unit of analysis., Main Outcomes and Measures: For each fill in 2016 by the patient and each family member enrolled in the same plan (eg, spouse or child), the number of prescribers and number of pharmacies in the prior 12 months were counted. Prescriber and pharmacy shopping was defined as 4 or more prescribers and 4 or more pharmacies, following a National Quality Forum-endorsed measure. The proportion of fills for which 1 or more family member met criteria and the proportion for which the patient met criteria were calculated., Results: Among 554 417 patients in the sample, 301 297 (54.3%) were female and 48 047 (8.7%) were children. Mean (SD) age was 41.4 (16.4) years. Patients were enrolled in 469 913 plans and, after exclusions, filled 1 471 971 opioid prescriptions in 2016. For 8485 fills (0.6%), 1 or more family member met prescriber and pharmacy shopping criteria. For 44 547 fills (3.0%), the patient met criteria. For 6947 of the 8485 fills (81.9%) for which 1 or more family member met criteria, patients did not meet criteria. When criteria were 3 or more prescribers at 3 or more pharmacies, the proportion of fills for which 1 or more family member met criteria increased to 1.9%., Conclusions and Relevance: In this national study of US patients with private family insurance plans, 0.6% of opioid prescription fills occurred when at least 1 of the patient's family members met prescriber and pharmacy shopping criteria. For most of these fills, patients did not meet criteria. Findings suggest the potential for opioid diversion within families.

Background: Decades-long efforts to require parity between behavioral and physical health insurance coverage culminated in the comprehensive federal Mental Health Parity and Addiction Equity Act., Objectives: To determine the association between federal parity and changes in mental health care utilization and spending, particularly among high utilizers., Research Design: Difference-in-differences analyses compared changes before and after exposure to federal parity versus a comparison group., Subjects: Commercially insured enrollees aged 18-64 with a mental health disorder drawn from 24 states where self-insured employers were newly subject to federal parity in 2010 (exposure group), but small employers were exempt before-and-after parity (comparison group). A total of 11,226 exposure group members were propensity score matched (1:1) to comparison group members, all of whom were continuously enrolled from 1 year prepolicy to 1-2 years postpolicy., Measures: Mental health outpatient visits, out-of-pocket spending for these visits, emergency department visits, and hospitalizations., Results: Relative to comparison group members, mean out-of-pocket spending per outpatient mental health visit declined among exposure enrollees by $0.74 (1.40, 0.07) and $2.03 (3.17, 0.89) in years 1 and 2 after the policy, respectively. Corresponding annual mental health visits increased by 0.31 (0.12, 0.51) and 0.59 (0.37, 0.81) per enrollee. Difference-in-difference changes were larger for the highest baseline quartile mental health care utilizers [year 2: 0.76 visits per enrollee (0.14, 1.38); relative increase 10.07%] and spenders [year 2: $-2.28 (-3.76, -0.79); relative reduction 5.91%]. There were no significant difference-in-differences changes in emergency department visits or hospitalizations., Conclusions: In 24 states, commercially insured high utilizers of mental health services experienced modest increases in outpatient mental health visits 2 years postparity.

The evidence for cannabis's treatment efficacy across different conditions varies widely, and comprehensive data on the conditions for which people use cannabis are lacking. We analyzed state registry data to provide nationwide estimates characterizing the qualifying conditions for which patients are licensed to use cannabis medically. We also compared the prevalence of medical cannabis qualifying conditions to recent evidence from the National Academies of Sciences, Engineering, and Medicine report on cannabis's efficacy in treating each condition. Twenty states and the District of Columbia had available registry data on patient numbers, and fifteen states had data on patient-reported qualifying conditions. Chronic pain is currently and historically the most common qualifying condition reported by medical cannabis patients (64.9 percent in 2016). Of all patient-reported qualifying conditions, 85.5 percent had either substantial or conclusive evidence of therapeutic efficacy. As medical cannabis use continues to increase, creating a nationwide patient registry would facilitate better understanding of trends in use and of its potential effectiveness.

Background: Families of children with mental health conditions face heavy economic burdens. One of the objectives of the Mental Health Parity and Addiction Equity Act (MHPAEA) is to reduce the financial burden for those with intensive mental health service needs. Few researchers to date have examined MHPAEA's effects on children with mental health conditions and those with particularly high mental health expenditures., Methods: A difference-in-differences approach was used to compare commercially insured children ages 3 to 18 years (in 2008) who were continuously enrolled in plans newly subject to parity under MHPAEA to children continuously enrolled in plans never subject to parity. Data included inpatient, outpatient, and pharmaceutical claims for 2008-2012 from 3 national commercial insurers. We examined annual mental health service use and spending outcomes., Results: Among children with mental health conditions who were enrolled in plans subject to parity, parity was associated with $140 (95% confidence interval: -$196 to -$84) lower average annual out-of-pocket (OOP) mental health spending than expected given changes in the comparison group. Among children who were ≥85th percentile in total mental health spending, parity was associated with $234 (-$391 to -$76) lower average annual OOP mental health spending., Conclusions: MHPAEA was associated with increased financial protection on average for children with mental health conditions and among those at the higher end of the spending distribution. However, estimated reductions in OOP spending were likely too modest to have substantially reduced financial burden on families of children with particularly high mental health expenditures., Competing Interests: POTENTIAL CONFLICT OF INTEREST: Dr Epstein is an employee of Medicus Economics, LLC, a consulting firm with clients in the biopharmaceutical industry; the other authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2018 by the American Academy of Pediatrics.)

At least 2.3 million people in the U.S. have an opioid use disorder, less than 40% of whom receive evidence-based treatment. Buprenorphine used as part of medication-assisted treatment has high potential to address this gap because of its approval for use in non-specialty outpatient settings, effectiveness at promoting abstinence, and cost effectiveness. However, less than 4% of licensed physicians are approved to prescribe buprenorphine for opioid use disorder, and approximately 47% of counties lack a buprenorphine-waivered physician. Existing policies contribute to workforce barriers to buprenorphine provision and access. Providers are reticent to prescribe buprenorphine because of workforce barriers, such as (1) insufficient training and education on opioid use disorder treatment, (2) lack of institutional and clinician peer support, (3) poor care coordination, (4) provider stigma, (5) inadequate reimbursement from private and public insurers, and (6) regulatory hurdles to obtain the waiver needed to prescribe buprenorphine in non-addiction specialty treatment settings. Policy pathways to addressing these provider workforce barriers going forward include providing free and easy-to-access education for providers about opioid use disorders and medication-assisted treatment, eliminating buprenorphine waiver requirements for those licensed to prescribe controlled substances, enforcing insurance parity requirements, requiring coverage of evidence-based medication-assisted treatment as essential health benefits, and providing financial incentives for care coordination across healthcare professional types-including behavioral health counselors and other non-physicians in specialty and non-specialty settings., Supplement Information: This article is part of a supplement entitled The Behavioral Health Workforce: Planning, Practice, and Preparation, which is sponsored by the Substance Abuse and Mental Health Services Administration and the Health Resources and Services Administration of the U.S. Department of Health and Human Services., (Copyright © 2018 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.)

State prescription drug monitoring programs (PDMPs) aim to reduce risky controlled-substance prescribing, but early programs had limited impact. Several states implemented robust features in 2012-13, such as mandates that prescribers register with the program and regularly check its registry database. Some states allow prescribers to fulfill the latter requirement by designating delegates to check the registry. The effects of robust PDMP features have not been fully assessed. We used commercial claims data to examine the effects of implementing robust PDMPs in four states on overall and high-risk opioid prescribing, comparing those results to trends in similar states without robust PDMPs. By the end of 2014 the absolute mean morphine-equivalent dosages that providers dispensed declined in a range of 6-77 mg per person per quarter in the four states, relative to comparison states. Only in one of the four states, Kentucky, did the percentage of people who filled opioid prescriptions decline versus its comparator state, with an absolute reduction of 1.6 percent by the end of 2014. Robust PDMPs may be able to significantly reduce opioid dosages dispensed, percentages of patients receiving opioids, and high-risk prescribing.