Did prescribing laws disproportionately affect opioid dispensing to Black patients?

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.

Has Declining Opioid Dispensing to Cancer Patients Been Tailored to Risk of Opioid Harms?

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.

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.

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.

Association of State Opioid Duration Limits With Postoperative Opioid Prescribing.

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.

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.