BACKGROUND: Opioid use disorder (OUD) affects millions of individuals each year in the United States. Patient retention in medications for opioid use disorder (MOUD) treatment is suboptimal. This study examines and quantifies the associations between each additional month of buprenorphine or methadone use and nonprescribed opioid use. METHODS: Data were obtained from an 18-month longitudinal, observational cohort study of patients (age ≥ 18 years) treated for OUD. Patients completed a baseline self-reported questionnaire between March 2018 and December 2019 and were asked to complete follow-up questionnaires at approximately 3-, 6-, 12-, and 18-months post-baseline until May 2021. Patients treated with buprenorphine or methadone, without taking other MOUD at least 12 months prior to baseline, were included. Outcomes included past 30-day use of prescription opioids nonmedically, heroin, or illegally made fentanyl. A multivariable, multilevel regression model with a binomial distribution and a logit link was used to estimate adjusted odds ratios (aORs) and 95% confidence intervals (CIs). RESULTS: This study included 353 patients taking buprenorphine (mean [standard deviation, SD] age 39 [11] years; 226 [64%] female), and 785 patients taking methadone (mean [SD] age 42 [12] years; 392 [50%] female). Each additional month of MOUD treatment was associated with a 25% decrease in the odds of past 30-day nonprescribed opioid use for patients taking buprenorphine (aOR [95% CI] = 0.75 [0.68-0.83]), and a 17% decrease for patients taking methadone (aOR = 0.83 [0.79-0.87]). The COVID-19 pandemic (aOR = 9.29 [2.96-29.17]; aOR = 3.19 [1.74-5.86]) and MOUD adverse reaction experiences (aOR = 3.07 [1.11-8.48]; aOR = 2.51 [1.01-6.22]) were significantly associated with higher odds of nonprescribed opioid use among buprenorphine and methadone groups. CONCLUSION: Among patients treated with buprenorphine or methadone, with each additional treatment month since baseline, those who continued with treatment appeared to be more likely to report 17% to 25% decreased odds of past 30-day nonprescribed opioid use. Our findings can be used by clinicians in the shared decision-making process with patients, emphasizing the value of sustained retention in MOUD.

IMPORTANCE: Recognizing and providing services to individuals at highest risk for drug overdose are paramount to addressing the drug overdose crisis. OBJECTIVE: To examine receipt of medications for opioid use disorder (MOUD), naloxone, and behavioral health services in the 12 months after an index nonfatal drug overdose and the association between receipt of these interventions and fatal drug overdose. DESIGN, SETTING, AND PARTICIPANTS: This cohort study was conducted in the US from January 2020 to December 2021 using claims, demographic, mortality, and other data from the Centers for Medicare & Medicaid Services, the Centers for Disease Control and Prevention, and other sources. The cohort comprised Medicare fee-for-service beneficiaries aged 18 years or older with International Statistical Classification of Diseases, Tenth Revision, Clinical Modification codes for a nonfatal drug overdose. Data analysis was performed from February to November 2023. EXPOSURES: Demographic and clinical characteristics, substance use disorder, and psychiatric comorbidities. MAIN OUTCOMES AND MEASURES: Receipt of MOUD, naloxone, and behavioral health services as well as subsequent nonfatal and fatal drug overdoses. RESULTS: The cohort consisted of 136 762 Medicare beneficiaries (80 140 females [58.6%]; mean (SD) age of 68.2 [15.0] years) who experienced an index nonfatal drug overdose in 2020. The majority of individuals had Hispanic (5.8%), non-Hispanic Black (10.9%), and non-Hispanic White (78.8%) race and ethnicity and lived in metropolitan areas (78.9%). In the 12 months after their index nonfatal drug overdose, 23 815 beneficiaries (17.4%) experienced at least 1 subsequent nonfatal drug overdose and 1323 (1.0%) died of a fatal drug overdose. Opioids were involved in 72.2% of fatal drug overdoses. Among the cohort, 5556 (4.1%) received any MOUD and 8530 (6.2%) filled a naloxone prescription in the 12 months after the index nonfatal drug overdose. Filling a naloxone prescription (adjusted odds ratio [AOR], 0.70; 95% CI, 0.56-0.89), each percentage of days receiving methadone (AOR, 0.98; 95% CI, 0.98-0.99) or buprenorphine (AOR, 0.99; 95% CI, 0.98-0.99), and receiving behavioral health assessment or crisis services (AOR, 0.25; 95% CI, 0.22-0.28) were all associated with reduced adjusted odds of fatal drug overdose in the 12 months after the index nonfatal drug overdose. CONCLUSIONS AND RELEVANCE: This cohort study found that, despite their known association with reduced risk of a fatal drug overdose, only a small percentage of Medicare beneficiaries received MOUD or filled a naloxone prescription in the 12 months after a nonfatal drug overdose. Efforts to improve access to behavioral health services; MOUD; and overdose-prevention strategies, such as prescribing naloxone and linking individuals to community-based health care settings for ongoing care, are needed.

IMPORTANCE: Given the high number of opioid overdose deaths in the US and the complex epidemiology of opioid use disorder (OUD), systems models can serve as a tool to identify opportunities for public health interventions. OBJECTIVE: To estimate the projected 3-year association between public health interventions and opioid overdose-related outcomes among persons with OUD. DESIGN, SETTING, AND PARTICIPANTS: This decision analytical model used a simulation model of the estimated US population aged 12 years and older with OUD that was developed and analyzed between January 2019 and December 2023. The model was parameterized and calibrated using 2019 to 2020 data and used to estimate the relative change in outcomes associated with simulated public health interventions implemented between 2021 and 2023. MAIN OUTCOMES AND MEASURES: Projected OUD and medications for OUD (MOUD) prevalence in 2023 and number of nonfatal and fatal opioid-involved overdoses among persons with OUD between 2021 and 2023. RESULTS: In a baseline scenario assuming parameters calibrated using 2019 to 2020 data remained constant, the model projected more than 16 million persons with OUD not receiving MOUD treatment and nearly 1.7 million persons receiving MOUD treatment in 2023. Additionally, the model projected over 5 million nonfatal and over 145 000 fatal opioid-involved overdoses among persons with OUD between 2021 and 2023. When simulating combinations of interventions that involved reducing overdose rates by 50%, the model projected decreases of up to 35.2% in nonfatal and 36.6% in fatal opioid-involved overdoses among persons with OUD. Interventions specific to persons with OUD not currently receiving MOUD treatment demonstrated the greatest reduction in numbers of nonfatal and fatal overdoses. Combinations of interventions that increased MOUD initiation and decreased OUD recurrence were projected to reduce OUD prevalence by up to 23.4%, increase MOUD prevalence by up to 137.1%, and reduce nonfatal and fatal opioid-involved overdoses among persons with OUD by 6.7% and 3.5%, respectively. CONCLUSIONS AND RELEVANCE: In this decision analytical model study of persons with OUD, findings suggested that expansion of evidence-based interventions that directly reduce the risk of overdose fatality among persons with OUD, such as through harm reduction efforts, could engender the highest reductions in fatal overdoses in the short-term. Interventions aimed at increasing MOUD initiation and retention of persons in treatment projected considerable improvement in MOUD and OUD prevalence but could require a longer time horizon for substantial reductions in opioid-involved overdoses.

IMPORTANCE: Evidence suggests that opioid prescribing was reduced nationally following the 2016 release of the Guideline for Prescribing Opioids for Chronic Pain by the US Centers for Diseases Control and Prevention (CDC). State-to-state variability in postguideline changes has not been quantified and could point to further avenues for reducing opioid-related harms. OBJECTIVE: To estimate state-level changes in opioid dispensing following the 2016 CDC Guideline release and explore state-to-state heterogeneity in those changes. DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study included information on opioid prescriptions for US individuals between 2012 and 2018 from an administrative database. Serial cross-sections of monthly opioid dispensing trajectories in each US state and the District of Columbia were analyzed using segmented regression to characterize preguideline dispensing trajectories and to estimate how those trajectories changed following the 2016 guideline release. Data were analyzed January to March 2023. EXPOSURE: The March 2016 CDC Guideline for Prescribing Opioids for Chronic Pain. MAIN OUTCOMES AND MEASURES: Four measures of opioid dispensing: opioid dispensing rate per 100 000 persons, long-acting opioid dispensing rate per 100 000 persons, high-dose (90 or more morphine milligram equivalents [MME] per day) dispensing rate per 100 000 persons, and average per capita MME. All measures were calculated monthly, from January 2012 through December 2018. RESULTS: Data from approximately 58 900 retail pharmacies were included in analysis, representing approximately 92% of US retail prescriptions. The overall monthly dispensing rate in the US in early 2012 was approximately 7000 per 100 000 population. Following the 2016 guideline release, the already-decreasing slope accelerated nationally for the overall dispensing rate (preguideline slope, -23.19; postguideline slope, -48.97; change in slope, 25.97 [95% CI, 18.67-32.95]), long-acting dispensing rate (preguideline slope, -1.03; postguideline slope, -5.94; change in slope, 4.90 [95% CI, 4.26-5.55]), high-dose dispensing (preguideline slope, -3.52; postguideline slope, -7.63; change in slope, 4.11 [95% CI, 3.49-4.73]), and per-capita MME (preguideline slope, -0.22; postguideline slope, -0.58; change in slope, 0.36 [95% CI, 0.30-0.42]). For all outcomes, nearly all states showed analogous acceleration of an already-decreasing slope, but there was substantial state-to-state heterogeneity. Slope changes (preguideline - postguideline slope) ranged from 9.15 (Massachusetts) to 74.75 (Mississippi) for overall dispensing, 1.88 (Rhode Island) to 13.41 (Maine) for long-acting dispensing, 0.71 (District of Columbia) to 13.68 (Maine) for high-dose dispensing, and 0.06 (Hawaii) to 0.91 (Arkansas) for per capita MME. CONCLUSIONS AND RELEVANCE: The 2016 CDC Guideline release was associated with broad reductions in prescription opioid dispensing, and those changes showed substantial geographic variability. Determining the factors associated with these state-level differences may inform further improvements to ensure safe prescribing practices.

OBJECTIVE: To improve patient safety and pain management, the Centers for Disease Control and Prevention (CDC) released the Guideline for Prescribing Opioids for Chronic Pain (CDC Guideline). Recognizing that issuing a guideline alone is insufficient for transforming practice, CDC supported an Opioid Quality Improvement (QI) Collaborative, consisting of 10 health care systems that represented more than 120 practices across the United States. The research team identified factors related to implementation success using domains described by the integrated Promoting Action on Research Implementation in Health Services (iPARIHS) implementation science framework. METHODS: Data from interviews, notes from check-in calls, and documents provided by systems were used. The researchers collected data throughout the project through interviews, meeting notes, and documents. RESULTS: The iPARIHS framework was used to identify factors that affected implementation related to the context, innovation (implementing recommendations from the CDC Guideline), recipient (clinicians), and facilitation (QI team). Contextual characteristics were at the clinic, health system, and broader external context, including staffing and leadership support, previous QI experience, and state laws. Characteristics of the innovation were its adaptability and challenges operationalizing the measures. Recipient characteristics included belief in the importance of the innovation but challenges engaging in the initiative. Finally, facilitation characteristics driving differential outcomes included staffing and available time of the QI team, the ability to make changes, and experience with QI. CONCLUSION: As health care systems continue to implement the CDC Guideline, these insights can advance successful implementation efforts by describing common implementation challenges and identifying strategies to prepare for and overcome them.

IMPORTANCE: Federal emergency authorities were invoked during the COVID-19 pandemic to expand clinical telehealth for opioid use disorder (OUD). OBJECTIVE: To examine the association of the receipt of telehealth services and medications for OUD (MOUD) with fatal drug overdoses before and during the pandemic. DESIGN, SETTING, AND PARTICIPANTS: This cohort study used exploratory longitudinal data from 2 cohorts (prepandemic cohort: September 1, 2018, to February 29, 2020; pandemic cohort: September 1, 2019, to February 28, 2021) of Medicare Fee-for-Service beneficiaries aged 18 years or older initiating an episode of OUD-related care using Medicare Fee-for-Service data from the Centers for Medicare & Medicaid Services and National Death Index data from the Centers for Disease Control and Prevention. Data analysis was performed from September 19 to October 17, 2022. EXPOSURES: Prepandemic vs pandemic cohort demographic, medical, substance use, and psychiatric characteristics. MAIN OUTCOMES AND MEASURES: Receipt of OUD-related telehealth services, receipt of MOUD, and fatal drug overdose. RESULTS: The prepandemic cohort comprised 105 162 beneficiaries (58.1% female; 67.6% aged 45-74 years). The pandemic cohort comprised 70 479 beneficiaries (57.1% female; 66.3% aged 45-74 years). The rate of all-cause mortality was higher in the pandemic cohort (99.9 per 1000 beneficiaries; 7041 deaths) than in the prepandemic cohort (76.8 per 1000; 8076 deaths) (P < .001). The rate of fatal drug overdoses was higher in the pandemic cohort (5.1 per 1000 beneficiaries; n = 358) than in the prepandemic cohort (3.7 per 1000; n = 391) (P < .001). The percentage of deaths due to a fatal drug overdose was similar in the prepandemic (4.8%) and pandemic (5.1%) cohorts (P = .49). In multivariable analysis of the pandemic cohort, receipt of OUD-related telehealth was associated with a significantly lower adjusted odds ratio (aOR) for fatal drug overdose (aOR, 0.67; 95% CI, 0.48-0.92) as was receipt of MOUD from opioid treatment programs (aOR, 0.41; 95% CI, 0.25-0.68) and receipt of buprenorphine in office-based settings (aOR, 0.62; 95% CI, 0.43-0.91) compared with those not receiving MOUD; receipt of extended-release naltrexone in office-based settings was not associated with lower odds for fatal drug overdose (aOR, 1.16; 95% CI, 0.41-3.26). CONCLUSIONS AND RELEVANCE: This cohort study found that, among Medicare beneficiaries initiating OUD-related care during the COVID-19 pandemic, receipt of OUD-related telehealth services was associated with reduced risk for fatal drug overdose, as was receipt of MOUD from opioid treatment programs and receipt of buprenorphine in office-based settings. Strategies to expand provision of MOUD, increase retention in care, and address co-occurring physical and behavioral health conditions are needed.

IMPORTANCE: Federal emergency authorities were invoked during the COVID-19 pandemic to expand use of telehealth for new and continued care, including provision of medications for opioid use disorder (MOUD). OBJECTIVE: To examine receipt of telehealth services, MOUD (methadone, buprenorphine, and extended-release [ER] naltrexone) receipt and retention, and medically treated overdose before and during the COVID-19 pandemic. DESIGN, SETTING, AND PARTICIPANTS: This exploratory longitudinal cohort study used data from the US Centers for Medicare & Medicaid Services from September 2018 to February 2021. Two cohorts (before COVID-19 pandemic from September 2018 to February 2020 and during COVID-19 pandemic from September 2019 to February 2021) of Medicare fee-for-service beneficiaries 18 years and older with an International Statistical Classification of Diseases, Tenth Revision, Clinical Modification OUD diagnosis. EXPOSURES: Pre-COVID-19 pandemic vs COVID-19 pandemic cohort demographic characteristics, medical and substance use, and psychiatric comorbidities. MAIN OUTCOMES AND MEASURES: Receipt and retention of MOUD, receipt of OUD and behavioral health-related telehealth services, and experiencing medically treated overdose. RESULTS: The pre-COVID-19 pandemic cohort comprised 105 240 beneficiaries; of these, 61 152 (58.1%) were female, 71 152 (67.6%) were aged 45 to 74 years, and 82 822 (79.5%) non-Hispanic White. The COVID-19 pandemic cohort comprised 70 538 beneficiaries; of these, 40 257 (57.1%) were female, 46 793 (66.3%) were aged 45 to 74 years, and 55 510 (79.7%) were non-Hispanic White. During the study period, a larger percentage of beneficiaries in the pandemic cohort compared with the prepandemic cohort received OUD-related telehealth services (13 829 [19.6%] vs 593 [0.6%]; P < .001), behavioral health-related telehealth services (28 902 [41.0%] vs 1967 [1.9%]; P < .001), and MOUD (8854 [12.6%] vs 11 360 [10.8%]; P < .001). The percentage experiencing a medically treated overdose during the study period was similar (18.5% [19 491 of 105 240] in the prepandemic cohort vs 18.4% [13 004 of 70 538] in the pandemic cohort; P = .65). Receipt of OUD-related telehealth services in the pandemic cohort was associated with increased odds of MOUD retention (adjusted odds ratio [aOR], 1.27; 95% CI, 1.14-1.41) and lower odds of medically treated overdose (aOR, 0.67; 95% CI, 0.63-0.71). Among beneficiaries in the pandemic cohort, those receiving MOUD from opioid treatment programs only (aOR, 0.54; 95% CI, 0.47-0.63) and those receiving buprenorphine from pharmacies only (aOR, 0.91; 95% CI, 0.84-0.98) had lower odds of medically treated overdose compared with beneficiaries who did not receive MOUD. CONCLUSIONS AND RELEVANCE: Emergency authorities to expand use of telehealth and provide flexibilities for MOUD provision during the pandemic were used by Medicare beneficiaries initiating an episode of OUD-related care and were associated with improved retention in care and reduced odds of medically treated overdose. Strategies to expand provision of MOUD and increase retention in care are urgently needed.

IMPORTANCE: In 2016, the Centers for Disease Control and Prevention (CDC) released the evidence-based Guideline for Prescribing Opioids for Chronic Pain. How the release of this guideline coincided with changes in nonopioid pain medication prescribing rates remains unknown. OBJECTIVE: To evaluate changes in nonopioid pain medication prescribing after the 2016 CDC guideline release and to assess the heterogeneity in these changes as a function of patient demographic and clinical characteristics. DESIGN, SETTING, AND PARTICIPANTS: This cohort study constructed 7 (4 preguideline and 3 postguideline) annual cohorts using claims data from the national Optum Clinformatics Data Mart Database for the period January 1, 2011, through December 31, 2018. The cohorts included adults with commercial insurance, no cancer or palliative care claims, and 2 years of continuous insurance enrollment. Individuals could qualify for inclusion in multiple cohorts. Each cohort covered a 2-year period, with year 1 as the baseline period used to calculate opioid exposure and other clinical characteristics and year 2 as the follow-up period used to calculate prescribing outcomes. Data were analyzed in March 2022. EXPOSURES: The CDC guideline, which was released in March 2016. MAIN OUTCOMES AND MEASURES: The primary outcome was receipt of any nonopioid pain medication prescriptions (analgesics or antipyretics, anticonvulsants, antidepressants, and nonsteroidal anti-inflammatory drugs) during the follow-up period. This postguideline prescribing pattern was compared with estimates based on the preguideline prescribing pattern, and then the differences were stratified by patient clinical characteristics (chronic pain, recent opioid exposure, substance use disorder, anxiety disorder, and mood disorder). RESULTS: A total of 15 879 241 individuals (2015 mean [SD] age, 50.2 [18.6] years; 8 298 271 female patients [52.3%]) qualified for inclusion in 1 or more cohorts. Logistic regression models showed that nonopioid pain medication prescribing odds were higher by 3.0% (95% CI, 2.6%-3.3%) in postguideline year 1, by 8.7% (95% CI, 8.3%-9.2%) in postguideline year 2, and by 9.7% (95% CI, 9.2%-10.3%) in postguideline year 3 than the preguideline pattern-based estimates. The magnitude of the postguideline departures from the preguideline pattern varied by several clinical characteristics (chronic pain, recent opioid exposure, anxiety disorder, and mood disorder). The largest departure was found among those with chronic pain, with postguideline prescribing being higher than estimated in postguideline year 2 (13.6%; 95% CI, 12.7%-14.6%) and postguideline year 3 (14.9%; 95% CI, 13.8%-16.0%). CONCLUSIONS AND RELEVANCE: Results of this study showed increases in nonopioid pain medication prescribing after the release of the 2016 CDC guideline, suggesting that the guideline may be associated with an increase in guideline-concordant care, but additional studies are needed to understand the role of other secular changes in the opioid policy landscape and other sources of nonopioid medication use.

In response to the opioid overdose crisis, the Centers for Disease Control and Prevention (CDC) released the Guideline for Prescribing Opioids for Chronic Pain (CDC Guideline) in 2016, which included recommendations to initiate opioids carefully and only when expected benefits outweigh risks.1 Although opioid prescriptions have decreased in recent years,2 an estimated 9.4 million people misused opioids in 2020.3 Little is known about how prescriptions dispensed to opioid-naive individuals (i.e., those new to opioid therapy) have changed in recent years; previous research focused on commercially insured individuals from 2012 to 2017.4 Understanding these patterns is important given the association between initial opioid-prescribing characteristics, such as prescription duration, and the likelihood of long-term use.5 This study examines previous opioid prescription history and initial prescription characteristics among individuals with dispensed opioid prescriptions from 2017 through 2020 using a large all-payer pharmaceutical claims database.

BACKGROUND: While reduced exposure to prescription opioids may decrease risks, including overdose and opioid use disorder, abrupt tapering or discontinuation may pose new risks. OBJECTIVES: To examine potentially unsafe tapering and discontinuation among dosage changes in opioid prescriptions dispensed to US patients on high-dose long-term opioid therapy. DESIGN: Longitudinal observational study of adults (18 years) on stable high-dose (50 oral morphine milligram equivalents [MME] daily dosage) long-term opioid therapy during a 180-day baseline and a 360-day follow-up using all-payer pharmaceutical claims data, 2017-2019. MEASURES: Dosage tapering, increases, and/or stability during follow-up; sustained dosage stability, reductions, or discontinuation at the end of follow-up; and tapering rate. Patients could experience more than one outcome during follow-up. RESULTS: Among 595,078 patients receiving high-dose long-term opioid therapy in the sample, 26.7% experienced sustained dosage reductions and 9.3% experienced discontinuation. Among patients experiencing tapering, 62.0% experienced maximum taper rates between >10-40% reductions per month and 36.1% experienced monthly rates 40%. Among patients with mean baseline daily dosages 150 MME, 47.7% experienced a maximum taper rate 40% per month. Relative to baseline, 19.7% of patients experiencing tapering had long-term dosage reductions 40% per month at the end of follow-up. IMPLICATIONS: Dosage changes for patients on high-dose long-term opioid therapy may warrant special attention, particularly over shorter intervals, to understand how potentially sudden tapering and discontinuation can be reduced while emphasizing patient safety and shared decision-making. Rapid discontinuation of opioids can increase risk of adverse outcomes including opioid withdrawal.

IMPORTANCE: The Centers for Disease Control and Prevention (CDC) released the "Guideline For Prescribing Opioids For Chronic Pain" (hereafter, CDC guideline) in 2016, but its association with prescribing practices for patients who are opioid naive is unknown. OBJECTIVE: To estimate changes in initial prescribing rates, duration, and dosage practices to patients who are opioid naive after the release of the CDC guideline. DESIGN, SETTING, AND PARTICIPANTS: This cohort study used 6 sequential cohorts to estimate preguideline trends in prescribing among patients who were opioid naive, project that trend forward, and compare it with postguideline prescribing practices. Participants included commercially insured adults without current cancer or hospice care diagnoses and with no past-year opioid claims in the US from 2011 to 2017. All adjusted models were controlled for patient demographics and state-fixed effects. Data were analyzed from January 2020 to May 2021. EXPOSURES: The release of the CDC guideline. MAIN OUTCOMES AND MEASURES: Indicators of any opioid prescription fills during a 9-month period, the number of days' supply of the initial prescription, and the binary indicator of whether the initial prescription was for 50 or more morphine milligram equivalents (MMEs) per day. RESULTS: There were 12 870 612 eligible unique patients across cohorts (mean [SD] age in 2016, 51.2 [18.7] years; 6 553 458 [50.9%] women); and the mean (SD) age of the cohorts increased annually, from 48.7 (17.9) years in the April 2011 to December 2012 cohort to 51.9 (19.2) years in the April 2016 to December 2017 cohort. The postguideline prescribing prevalence was 532 962 of 5 834 088 individuals (9.1%), which exceeded that projected from the preguideline trend, estimated at 9.0% (95% CI, 9.0%-9.1%). Among patients receiving prescriptions during follow-up, adjusted mean days' supply was 4.7% (95% CI, 4.3%-5.1%) lower in the first year after release of the guideline and 9.8% (95% CI, 9.3%-10.3%) lower in the second year after release, compared with the expected rate from the preguideline trend. The adjusted odds of receiving a high-dose (ie, ≥50 MME/d) initial prescription were lower in the first year (odds ratio, 0.97; 95% CI, 0.96-0.98) and in the second year (odds ratio, 0.94; 95% CI, 0.93-0.96) after the release of the CDC guideline compared with the odds expected from the preguideline trend. CONCLUSIONS AND RELEVANCE: This cohort study found that patients who were opioid naive continued to initiate opioid therapy after the release of opioid prescribing guidelines by the CDC, but trends in prescribing duration reversed and decreased, after increasing in each of 4 preguideline cohorts examined. High-dose prescribing rates were already decreasing, but those trends accelerated after the CDC guideline release. These results suggest that nonmandatory, evidence-based guidelines from trusted sources were associated with prescribing practices. Guideline-concordant care has potential to improve pain management and reduce opioid-related harms.

In 2019, 49,860 drug overdose deaths in the USA involved opioids.1 Naloxone can reverse the effects of an opioid overdose. While the CDC Guideline for Prescribing Opioids for Chronic Pain recommends that clinicians consider prescribing naloxone when factors that increase risk for opioid overdose are present, such as higher opioid dosages and the use of both opioid and benzodiazepines,2 the extent of concurrent naloxone dispensing among this population is unknown. Previous research, limited to Medicare beneficiaries, indicated that very few patients received concurrent naloxone prescriptions.3 Similarly, naloxone prescriptions dispensed from retail pharmacies remain low.4 We examine concurrent naloxone dispensing among individuals with high-risk opioid prescriptions in the USA from 2015 to 2019.

Importance: Although opioids can be effective medications in certain situations, they are associated with harms, including opioid use disorder and overdose. Studies have revealed unexplained prescribing variation and prescribing mismatched with patient-reported pain for many indications. Objective: To summarize opioid prescribing frequency, dosages, and durations, stratified across numerous painful medical indications. Design, Setting, and Participants: Retrospective cross-sectional analysis of 2017 US administrative claims data among outpatient clinical settings, including postsurgical discharge. Participants had any of 41 different indications associated with nonsurgical acute or chronic pain or postsurgical pain or pain associated with sickle cell disease or active cancer and were enrolled in either private insurance (including Medicare Advantage) in the OptumLabs Data Warehouse data set (n = 18016259) or Medicaid in the IBM MarketScan Multi-State Medicaid Database (n = 11453392). OptumLabs data were analyzed from October 2018 to March 2019; MarketScan data were analyzed from January to April 2019. Exposures: Nonsurgical acute or chronic pain or postsurgical pain; pain related to sickle cell disease or active cancer. Main Outcomes and Measures: Indication-specific opioid prescribing rates; days' supply per prescription; daily opioid dosage in morphine milligram equivalents; and for chronic pain indications, the number of opioid prescriptions. Results: During the study period, of 18016259 eligible patients with private insurance, the mean (95% CI) age was 42.7 (42.7-42.7) years, and 50.3% were female; of 11453392 eligible Medicaid enrollees, the mean (95% CI) age was 20.4 (20.4-20.4) years, and 56.1% were female. A pain-related indication under study occurred in at least 1 visit among 6380694 patients with private insurance (35.4%) and 3169831 Medicaid enrollees (27.7%); 2270596 (35.6% of 6380694) privately insured patients and 1126508 (35.5% of 3169831) Medicaid enrollees had 1 or more opioid prescriptions. Nonsurgical acute pain opioid prescribing rates were lowest for acute migraines (privately insured, 4.6% of visits; Medicaid, 6.6%) and highest for rib fractures (privately insured, 44.8% of visits; Medicaid, 56.3%), with variable days' supply but similar daily dosage across most indications. Opioid prescribing for a given chronic pain indication varied depending on a patient's opioid use history. Days' supply for postoperative prescriptions was longest for combined spinal decompression and fusion (privately insured, 9.5 days [95% CI, 9.4-9.7 days]) or spinal fusion (Medicaid, 9.1 days [95% CI, 8.9-9.2 days]) and was shortest for vaginal delivery (privately insured, 4.1 days [95% CI, 4.1-4.1 days] vs Medicaid, 4.2 days [95% CI, 4.2-4.2 days]). Conclusions and Relevance: Indication-specific opioid prescribing rates were not always aligned with existing guidelines. Potential inconsistencies between prescribing practice and clinical recommendations, such as for acute and chronic back pain, highlight opportunities to enhance pain management and patient safety.

In 2017, prescription opioids were involved in 36% of opioid-involved overdose deaths in the United States (1). Prescription opioids can be obtained by prescription or through diversion (the channeling of regulated drugs from legal to illegal sources) (2). Among new heroin users, 66%-83% reported that their opioid use began with the misuse of a prescription opioid (3). "Misuse" is generally defined as drugs taken for a purpose other than that directed by the prescribing physician, in greater amounts, more often, or for a longer duration than prescribed (2). Exposure to prescription opioids can be lessened by ensuring recommended prescribing, thereby potentially reducing the risk for misuse, opioid use disorder, and overdose (4). Sex and age groups with high exposure to prescription opioids are not well defined. Using a retail pharmaceutical database from IQVIA,* nationwide trends in opioid prescription fill rates for adult outpatients by age and sex were examined during 2008-2018. Opioid prescription fill rates were disproportionately higher among men and women aged >/=65 years and women of all ages. For reasons not well understood, these disparities persisted over 11 years even as the opioid fill rate declined for each age group and sex. Interventions to improve prescribing practices by following evidence-based guidelines that include weighing the benefits and risks for using prescription opioids for each patient and adopting a multimodal approach to pain management could improve patient safety while ameliorating pain. These efforts might need to consider the unique needs of women and older adults, who have the highest opioid prescription fill rates.

BACKGROUND: The CDC Guideline for Prescribing Opioids for Chronic Pain recommends considering prescribing naloxone when factors that increase risk for overdose are present (e.g., history of overdose or substance use disorder, opioid dosages >/=50 morphine milligram equivalents per day [high-dose], and concurrent use of benzodiazepines). In light of the high numbers of drug overdose deaths involving opioids, 36% of which in 2017 involved prescription opioids, improving access to naloxone is a public health priority. CDC examined trends and characteristics of naloxone dispensing from retail pharmacies at the national and county levels in the United States. METHODS: CDC analyzed 2012-2018 retail pharmacy data from IQVIA, a health care, data science, and technology company, to assess U.S. naloxone dispensing by U.S. Census region, urban/rural status, prescriber specialty, and recipient characteristics, including age group, sex, out-of-pocket costs, and method of payment. Factors associated with naloxone dispensing at the county level also were examined. RESULTS: The number of naloxone prescriptions dispensed from retail pharmacies increased substantially from 2012 to 2018, including a 106% increase from 2017 to 2018 alone. Nationally, in 2018, one naloxone prescription was dispensed for every 69 high-dose opioid prescriptions. Substantial regional variation in naloxone dispensing was found, including a twenty-fivefold variation across counties, with lowest rates in the most rural counties. A wide variation was also noted by prescriber specialty. Compared with naloxone prescriptions paid for with Medicaid and commercial insurance, a larger percentage of prescriptions paid for with Medicare required out-of-pocket costs. CONCLUSION: Despite substantial increases in naloxone dispensing, the rate of naloxone prescriptions dispensed per high-dose opioid prescription remains low, and overall naloxone dispensing varies substantially across the country. Naloxone distribution is an important component of the public health response to the opioid overdose epidemic. Health care providers can prescribe or dispense naloxone when overdose risk factors are present and counsel patients on how to use it. Efforts to improve naloxone access and distribution work most effectively with efforts to improve opioid prescribing, implement other harm-reduction strategies, promote linkage to medications for opioid use disorder treatment, and enhance public health and public safety partnerships.

OBJECTIVE: Despite recent decreases in opioid prescribing rates, evidence suggests there is substantial variation in the way opioids are prescribed by providers. This study aims to identify patterns in high-volume opioid prescribing. METHODS: We conducted partitioning-around-medoids cluster analysis using the IQVIA Prescriber Profile dataset, including the number of opioid prescriptions filled at US retail pharmacies aggregated at the prescriber-level from July 2016 through June 2017. Clustering was used to identify prescription patterns within a sample of 10,000 high-volume opioid prescribers (defined as the top 10% of prescribers by number of opioid prescriptions during the 12-month period). Clustering variables included prescription counts by opioid type, and prescriber specialty, age, and region. RESULTS: Family medicine (32%), internal medicine (23%), and orthopedics (11%) were the most common high-volume prescribing specialties. Across specialties, hydrocodone and oxycodone were the most-frequently prescribed opioid types. Thirty-five clusters of prescribers were obtained, consistently comprised of a single majority specialty and region. All majority high-prescribing specialties were represented in Southern clusters, indicating consistently high volume opioid prescribing across specialties in the region. Prescribing patterns varied by drug type and region - across every Northeastern cluster, oxycodone prescribing was higher than hydrocodone. While clusters of pain medicine specialists had the highest median total prescriptions, emergency medicine specialist clusters had some of the lowest. CONCLUSIONS: These results provide a clearer picture of current patterns among high-volume prescribers, who accounted for almost two-thirds of all opioid prescriptions. In light of the ongoing opioid overdose epidemic, this knowledge is critical for prevention activities.

Importance: Despite epidemic rates of addiction and death from prescription opioids in the United States, suggesting the importance of providing alternatives to opioids in the treatment of pain, little is known regarding how payers' coverage policies may facilitate or impede access to such treatments. Objective: To examine coverage policies for 5 nonpharmacologic approaches commonly used to treat acute or chronic low back pain among commercial and Medicare Advantage insurance plans, plus an additional 6 treatments among Medicaid plans. Design, Setting, and Participants: Cross-sectional study of 15 commercial, 15 Medicaid, and 15 Medicare Advantage health plans for the 2017 calendar year in 16 states representing more than half of the US population. Interviews were conducted with 43 senior medical and pharmacy health plan executives from representative plans. Main Outcomes and Measures: Medical necessity and coverage status for the treatments examined, as well as the use of utilization management tools and cost-sharing magnitude and structure. Results: Commercial and Medicare insurers consistently regarded physical and occupational therapy as medically necessary, but policies varied for other therapies examined. Payers most commonly covered physical therapy (98% [44 of 45 plans]), occupational therapy (96% [43 of 45 plans]), and chiropractic care (89% [40 of 45 plans]), while transcutaneous electrical nerve stimulation (67% [10 of 15 plans]) and steroid injections (60% [9 of 15 plans]) were the most commonly covered among the therapies examined for Medicaid plans only. Despite evidence in the literature to support use of acupuncture and psychological interventions, these therapies were either not covered by plans examined (67% of all plans [30 of 45] did not cover acupuncture) or lacked information about coverage (80% of Medicaid plans [12 of 15] lacked information about coverage of psychological interventions). Utilization management tools, such as prior authorization, were common, but criteria varied greatly with respect to which conditions and what quantity and duration of services were covered. Interviewees represented 6 Medicaid managed care organizations, 2 Medicare Advantage or Part D plans, 9 commercial plans, and 3 trade organizations (eg, Blue Cross Blue Shield Association). Interviews with plan executives indicated a low level of integration between the coverage decision-making processes for pharmacologic and nonpharmacologic therapies for chronic pain. Conclusions and Relevance: Wide variation in coverage of nonpharmacologic treatments for low back pain may be driven by the absence of best practices, the administrative complexities of developing and revising coverage policies, and payers' economic incentives. Such variation suggests an important opportunity to improve the accessibility of services, reduce opioid use, and ultimately improve the quality of care for individuals with chronic, noncancer pain while alleviating the burden of opioid addiction and overdose.

Importance: Despite unprecedented injuries and deaths from prescription opioids, little is known regarding medication coverage policies for the treatment of chronic noncancer pain among US insurers. Objective: To assess medication coverage policies for 62 products used to treat low back pain. Design, Setting, and Participants: A cross-sectional study of health plan documents from 15 Medicaid, 15 Medicare Advantage, and 20 commercial health plans in 2017 from 16 US states representing more than half the US population and 20 interviews with more than 43 senior medical and pharmacy health plan executives from representative plans. Data analysis was conducted from April 2017 to January 2018. Main Outcomes and Measures: Formulary coverage, utilization management, and patient out-of-pocket costs. Results: Of the 62 products examined, 30 were prescription opioids and 32 were nonopioid analgesics, including 10 nonsteroidal anti-inflammatory drugs, 10 antidepressants, 6 muscle relaxants, 4 anticonvulsants, and 2 topical analgesics. Medicaid plans covered a median of 19 opioids examined (interquartile range [IQR], 12-27; median, 63%; IQR, 40%-90%) and a median of 22 nonopioids examined (IQR, 21-27; median, 69%; IQR, 66%-83%). Medicare Advantage plans covered similar proportions (median [IQR], opioids: 17 [15-22]; 57% [50%-73%]; nonopioids: 22 [22-26]; 69% [69%-81%]), while commercial plans covered more opioids (median [IQR], 23 [21-25]; 77% [70%-84%]) and nonopioids (median [IQR], 26 [24-27]; 81% [74%-85%]). Utilization management strategies were common for opioids in Medicaid plans (median [IQR], 15 [11-20] opioids; 91% [74%-97%]), Medicare Advantage plans (median [IQR], 15 [9-18] opioids; 100% [100%-100%]), and commercial plans (median [IQR], 16 [11-20] opioids; 74% [53%-94%]), generally relying on 30-day quantity limits rather than prior authorization. Step therapy was especially uncommon. Many of the nonopioids examined also were subject to utilization management, especially quantity limits (24%-32% of products across payers) and prior authorization (median [IQR], commercial plans: 2 [0-3] nonopioids; 9% [0%-11%]; Medicare Advantage plans: 4 [3-5] nonopioids; 19% [10%-23%]; Medicaid plans: 6 [1-13] nonopioids; 38% [2%-52%]). Among commercial plans, the median plan placed 18 opioids (74%) and 20 nonopioids (81%) in tier 1, which was associated with a median out-of-pocket cost of $10 (IQR, $9-$10) per 30-day supply. Key informant interviews revealed an emphasis on increasing opioid utilization management and identifying high-risk prescribers and patients, rather than promoting comprehensive strategies to improve treatment of chronic pain or better integrating pharmacologic and nonpharmacologic alternatives to opioids. Conclusions and Relevance: Given the effect of coverage policies on drug utilization and health outcomes, these findings provide an important opportunity to evaluate how formulary placement, utilization management, copayments, and integration of nonpharmacologic treatments can be optimized to improve pain care while reducing opioid-related injuries and deaths.

Background: In response to adverse outcomes from prescription opioids, the Centers for Disease Control and Prevention (CDC) released the Guideline for Prescribing Opioids for Chronic Pain in March 2016. Objective: To test the hypothesis that the CDC guideline release corresponded to declines in specific opioid prescribing practices. Design: Interrupted time series analysis of monthly prescribing measures from the IQVIA transactional data warehouse and Real-World Data Longitudinal Prescriptions population-level estimates based on retail pharmacy data. Population size was determined by U.S. Census monthly estimates. Setting: United States, 2012 to 2017. Patients: Persons prescribed opioid analgesics. Measurements: Outcomes included opioid dosage, days supplied, overlapping benzodiazepine prescriptions, and the overall rate of prescribing. Results: The rate of high-dosage prescriptions (>/=90 morphine equivalent milligrams per day) was 683 per 100 000 persons in January 2012 and declined by 3.56 (95% CI, -3.79 to -3.32) per month before March 2016 and by 8.00 (CI, -8.69 to -7.31) afterward. Likewise, the percentage of patients with overlapping opioid and benzodiazepine prescriptions was 21.04% in January 2012 and declined by 0.02% (CI, -0.04% to -0.01%) per month before the CDC guideline release and by 0.08% (CI, -0.08% to -0.07%) per month afterward. The overall opioid prescribing rate was 6577 per 100 000 persons in January 2012 and declined by 23.48 (CI, -26.18 to -20.78) each month before the guideline release and by 56.74 (CI, -65.96 to -47.53) per month afterward. Limitation: No control population; inability to determine the appropriateness of opioid prescribing. Conclusion: Several opioid prescribing practices were decreasing before the CDC guideline, but the time of its release was associated with a greater decline. Guidelines may be effective in changing prescribing practices. Primary Funding Source: CDC.

BACKGROUND: This paper concerns public health crises today-the problem of opioid prescription access and related abuse. Inspired by Case and Deaton's seminal work on increasing mortality among white Americans with lower education, this paper explores the relationship between opioid prescribing and local economic factors. OBJECTIVE: We examined the association between county-level socioeconomic factors (median household income, unemployment rate, Gini index) and opioid prescribing. SUBJECTS: We used the complete 2014 Medicare enrollment and part D drug prescription data from the Center for Medicare and Medicaid Services to study opioid prescriptions of disabled Medicare beneficiaries without record of cancer treatment, palliative care, or end-of-life care. MEASURES AND RESEARCH DESIGN: We summarized the demographic and geographic variation, and investigated how the local economic environment, measured by county median household income, unemployment rate, Gini index, and urban-rural classification correlated with various measures of individual opioid prescriptions. Measures included number of filled opioid prescriptions, total days' supply, average morphine milligram equivalent (MME)/day, and annual total MME dosage. To assess the robustness of the results, we controlled for individual and other county characteristics, used multiple estimation methods including linear least squares, logistic regression, and Tobit regression. RESULTS AND CONCLUSIONS: Lower county median household income, higher unemployment rates, and less income inequality were consistently associated with more and higher MME opioid prescriptions among disabled Medicare beneficiaries. Geographically, we found that the urban-rural divide was not gradual and that beneficiaries in large central metro counties were less likely to have an opioid prescription than those living in other areas.

Understanding the relationship between opioid treatment for acute pain and subsequent long-term use is necessary to inform clinical decisions on pain treatment. Previous research has described long-term opioid use after treatment for acute pain in postoperative and fragility fracture treatment.1 – 3 We carefully examined the association between forearm and lower leg fractures in 2011 and opioid prescription in 2011–2014 among disabled Medicare beneficiaries who did not have opioid prescriptions in 2010. We focused on forearm and lower leg fractures because these injuries to major long bones not directly connected to the torso have limited long-term health consequences and are less likely to cause health complications.

This study uses US National Vital Statistics mortality data to assess change in US life expectancy from 2000 to 2015 attributable to opioid-involved poisonings.

RATIONALE, AIMS, AND OBJECTIVES: The United States is in the midst of a public health epidemic with more than 40 people dying each day from prescription opioid overdoses. Health care systems are taking steps to address the opioid overdose epidemic by implementing policy and practice interventions to mitigate the risks of long-term opioid therapy. Kaiser Permanente Southern California launched a comprehensive initiative to transform the way that chronic pain is viewed and treated. Kaiser Permanente Southern California created prescribing and dispensing policies, monitoring and follow-up processes, and clinical coordination through electronic health record integration. The purpose of this paper is to describe the implementation of these interventions and assess the impact of this set of interventions on opioid prescribing. METHOD: The study used a retrospective pre-post evaluation design to track outcomes before and after the intervention. Kaiser Permanente Southern California members age 18 and older excluding cancer, hospice, and palliative care patients and this sub-population of 3 203 880 was approximately 75% of all Kaiser Permanente Southern California members. All data are from Kaiser Permanente's pharmacy data systems and electronic health record collected on a rolling basis as interventions were implemented from January 2010 to December 2015. RESULTS: There were reductions in all tracked outcomes: a 30% reduction in prescribing opioids at high doses; a 98% reduction in the number of prescriptions with quantities greater than 200 pills; a 90% decrease in the combination of an opioid prescription with benzodiazepines and carisoprodol; a 72% reduction in the prescribing of Long Acting/Extended Release opioids; and a 95% reduction in prescriptions of brand name opioid-acetaminophen products. In addition, methadone prescribing did not increase during this period. CONCLUSIONS: This study adds promising results that a comprehensive system-level strategy has the ability to positively affect opioid prescribing. The basic components of the intervention are generalizable and applicable to other health care settings.

Evidence, particularly practice-based evidence, is needed to guide public health practice. With the goal of contributing to practice-based evidence, the Division for Heart Disease and Stroke Prevention at the Centers for Disease Control and Prevention combined and streamlined aspects of an evaluability assessment and an effectiveness evaluation to create the Enhanced Evaluability Assessment (EEA). This approach offers a viable and less costly alternative to evaluators and practitioners by quickly identifying and evaluating models with evidence of effectiveness that can be replicated and expanded. The EEA can be applied to a range of public health topics, not just cardiovascular health. This article provides a step-by-step description of the EEA.

RATIONALE, AIMS AND OBJECTIVES: In the United States, cardiovascular disease (CVD) is the leading cause of death. The US Centers for Disease Control and Prevention contracted an evaluation of the Aggressively Treating Global Cardiometabolic Risk Factors to Reduce Cardiovascular Events (AT GOAL) programme as part of its effort to identify strategies to address CVD risk factors. METHODS: This study analysed patient-level data from 7527 patients in 43 primary care practices. The researchers assessed average change in control rates for CVD-related measures across practices, and then across patients between baseline and a patient's last visit during the practice's tenure in the programme (referred to as 'end line') using repeated measures analysis of variance and random effects generalized least squares, respectively. RESULTS: Among non-diabetic patients, there were significant increases in control rates for overall blood pressure (74.3% to 78.0%, P = 0.0002), systolic blood pressure (70.3% to 80.6%, P = 0.0099), diastolic blood pressure (90.1% to 92.7%, P = 0.0001) and low-density lipoprotein (LDL; 48.6% to 53.1%, P = 0.0001) between baseline and end line. Among diabetic patients, there was a significant increase in diastolic blood pressure control (59.8% to 61.9%, P = 0.0141). While continuous CVD-related outcomes show an overall trend between baseline and end line, patients with uncontrolled measures at baseline showed a decrease between baseline and end line relative to their counterparts who were controlled at baseline. CONCLUSIONS: Findings from the AT GOAL evaluation support the value of a facilitated quality improvement (QI) initiative on managing CVD risk.

OBJECTIVES: Increasing demands on primary care providers have created a need for systems-level initiatives to improve primary care delivery. The purpose of this paper is to describe and present outcomes for two such initiatives: the Pennsylvania Academy of Family Physicians' Residency Program Collaborative (RPC) and the St. Johnsbury Vermont Community Health Team (CHT). METHODS: Researchers conducted case studies of the initiatives using mixed methods, including: secondary analysis of program and electronic health record data, systematic document review and interviews. RESULTS: RPC is a learning collaborative that teaches quality improvement and patient-centeredness to primary care providers, residents, clinical support staff, and administrative staff in residency programs. Results show that participation in a higher number of live learning sessions resulted in a significant increase in patient centered medical home recognition attainment and significant improvements in performance in diabetic process measures including eye exams (14.3%, p=0.004), eye referrals (13.82%, p=0.013), foot exams (15.73%, p=0.003), smoking cessation (15.83%, p=0.012), and self-management goals (25.45%, p=0.001). As a community-clinical linkages model, CHT involves primary care practices, community health workers (CHWs), and community partners. Results suggest that CHT members successfully work together to coordinate comprehensive care for the individuals they serve. Further, individuals exposed to CHWs experienced increased stability in access to health insurance (p=0.001) and prescription drugs (p=0.000), and the need for health education counseling (p=0.000). CONCLUSION: Findings from this study indicate that these two system-level strategies have the promise to improve primary care delivery. Additional research can determine the extent to which these strategies can improve other health outcomes.

BACKGROUND: Heart failure is a serious health condition that requires a significant amount of informal care. However, informal caregiving costs associated with heart failure are largely unknown. METHODS: We used a study sample of noninstitutionalized US respondents aged ≥50 years from the 2010 HRS (n = 19,762). Heart failure cases were defined by using self-reported information. The weekly informal caregiving hours were derived by a sequence of survey questions assessing (1) whether respondents had any difficulties in activities of daily living or instrumental activities of daily living, (2) whether they had caregivers because of reported difficulties, (3) the relationship between the patient and the caregiver, (4) whether caregivers were paid, and (5) how many hours per week each informal caregiver provided help. We used a 2-part econometric model to estimate the informal caregiving hours associated with heart failure. The first part was a logit model to estimate the likelihood of using informal caregiving, and the second was a generalized linear model to estimate the amount of informal caregiving hours used among those who used informal caregiving. Replacement approach was used to estimate informal caregiving cost. RESULTS: The 943 (3.9%) respondents who self-reported as ever being diagnosed with heart failure used about 1.6 more hours of informal caregiving per week than those who did not have heart failure (P < .001). Informal caregiving hours associated with heart failure were higher among non-Hispanic blacks (3.9 hours/week) than non-Hispanic whites (1.4 hours/week). The estimated annual informal caregiving cost attributable to heart failure was $3 billion in 2010. CONCLUSION: The cost of informal caregiving was substantial and should be included in estimating the economic burden of heart failure. The results should help public health decision makers in understanding the economic burden of heart failure and in setting public health priorities.

This article describes lessons learned from implementing sodium-reduction strategies in programs that provide meals to older adults in 2 New York counties, with one county replicating the approaches of the other. The implemented sodium-reduction strategies were product substitutions, recipe modifications, and cooking from scratch. Both counties were able to achieve modest sodium reductions in prepared meals. Lessons learned to implement sodium reduction strategies include the following: (1) identifying partners with shared experience and common goals; (2) engaging experts; (3) understanding the complexity of the meals system for older adults; (4) conducting sodium nutrient analysis; (5) making gradual and voluntary reductions to sodium content; and (6) working toward sustainable sodium reduction.

Practice-based evidence arises from programs implemented in real-world settings. Program success may be judged on the basis of experience; however, formal evaluation studies of methodological rigor can provide a high level of credible evidence to inform public health practice. Such studies can be lengthy and expensive. Furthermore, even well-designed studies may not reach conclusive findings, for example, when a program lacks full implementation, when data systems do not have capacity to collect evaluation data, or when program implementation has not attained stability. An evaluability assessment is used to determine the capacity and readiness of a program for full-scale effectiveness evaluation. Evaluators at the Centers for Disease Control and Prevention use evaluability assessment as a preevaluation consisting of brief, focused, criteria-based assessments, document review, and a site visit. Evaluability assessment is used to guide investments in subsequent rigorously designed evaluations that yield conclusive findings to build strong and credible practice-based evidence.