Common themes in early state policy responses to substance use disorder treatment during COVID-19.

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.

Trends in Suicidality 1 Year Before and After Birth Among Commercially Insured Childbearing Individuals in the United States, 2006-2017.

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.

The Complex Cancer Care Coverage Environment - What is the Role of Legislation? A Case Study from Massachusetts.

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.

A mixed-method comparison of physician-reported beliefs about and barriers to treatment with medications for opioid use disorder.

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.

The Public Health Value of Opioid Litigation.

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.

Opioid prescribing history prior to heroin overdose among commercially insured adults.

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.

Association of Medicare Part D Benzodiazepine Coverage Expansion With Changes in Fall-Related Injuries and Overdoses Among Medicare Advantage Beneficiaries.

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.

Legal requirements and recommendations to prescribe naloxone.

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.

The Association of State Opioid Misuse Prevention Policies With Patient- and Provider-Related Outcomes: A Scoping Review.

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.

Assessment of Prescriber and Pharmacy Shopping Among the Family Members of Patients Prescribed Opioids.

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.

Provider perceptions of system-level opioid prescribing and addiction treatment policies.

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.

Association of Federal Mental Health Parity Legislation With Health Care Use and Spending Among High Utilizers of Services.

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.

Generic Drug Policy and Suboxone to Treat Opioid Use Disorder.

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.

Federal Parity and Spending for Mental Illness.

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.

Four States With Robust Prescription Drug Monitoring Programs Reduced Opioid Dosages.

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.