Remote Physiologic Monitoring Use Among Medicaid Population Increased, 2019-21.

Remote physiologic monitoring use increased more than 1,300 percent from 2019 to 2021, and use varied by state. This increase was driven by a small number of (predominantly internal medicine) providers. Female beneficiaries, residents of metropolitan areas, and people diagnosed with diabetes or hypertension had the highest rates of use.

Assessing Geographic Variation in Rates of Cervical Cancer and Recurrent or Metastatic Cervical Cancer Among Medicaid Enrollees.

OBJECTIVE: The objective of this study was to evaluate trends in prevalence of cervical cancer (CC) and rates of recurrent or metastatic cervical cancer (r/mCC) treatment initiation at the state and metropolitan statistical area (MSA) levels among Medicaid enrolled females from 2016 to 2019. METHODS: Retrospective analyses of nationwide Medicaid claims data were used to identify adult CC and r/mCC patients from 2016 to 2019. CC prevalence was estimated as the proportion of females diagnosed with CC out of all adult female Medicaid beneficiaries, and r/mCC by the proportion of CC patients who initiated a systemic treatment not associated with surgery or radiation to the number of enrollees with CC diagnosis in each state or MSA. Overall and annual rates were calculated for each state and MSA from 2016 to 2019. RESULTS: The analytic cohort included 70,865 adult female Medicaid beneficiaries with CC from 2016 to 2019, among whom 3375 were identified as r/mCC patients. Nationwide annual prevalence of CC remained relatively stable from 2016 to 2019, while r/mCC decreased slightly over the study period. Several MSAs experienced increasing rates of r/mCC from 2016 to 2019, including Mayaguez, PR, Aguadeilla-Isabela, PR, and Green Bay, WI. CONCLUSIONS: Claims data demonstrate areas in the United States with disproportionately high or increasing CC or r/mCC burden, indicating a potential gap in preventative care for females and an unmet need for education and health care resource allocation. Future research should evaluate associations between community-level factors and r/mCC burden.

Patterns of care and health care resource use among Medicaid-enrolled women with recurrent or metastatic cervical cancer.

BACKGROUND: Cervical cancer is a public health challenge and remains a disease with high unmet need. Previous real-world studies demonstrated significant variability in treatments for patients with recurrent or metastatic cervical cancer (r/mCC). A large proportion of patients with cervical cancer are insured through Medicaid; however, previous studies examining treatment patterns for r/mCC have not included Medicaid patients. As the r/mCC treatment landscape continues to evolve, there is a need to understand current real-world unmet need among patients with r/mCC enrolled in Medicaid. OBJECTIVE: To evaluate treatment patterns and health care resource utilization (HCRU) among Medicaid-enrolled women with r/mCC. METHODS: This is a retrospective analysis of nationwide Medicaid claims to assess patient characteristics, treatment patterns, and HCRU among patients with r/mCC between 2016 and 2019. First-line treatment (1L) for r/mCC was defined by the first administration of systemic therapy without concomitant radiation or surgery. Patient characteristics, treatment patterns, and HCRU were characterized by line of therapy. RESULTS: A total of 3,375 eligible adult female patients initiated systemic treatment for r/mCC between 2016 and 2019. Mean age at treatment initiation was 52.9 (SD ± 12.8) years. Nearly 1,300 (1,294, 38.3%) women had evidence of receiving second-line treatment (2L), with nearly one-third (N = 420) of those also having evidence of third-line treatment. The majority (60.5%) of 1L regimens were doublet chemotherapy ± bevacizumab, consistent with treatment guidelines. In contrast, no clear preferred treatment choice was observed among patients receiving 2L or later (2L+) therapy. Notably, immunotherapy accounted for 21.6% of treatment regimens in 2L/3L overall, with its use increasing substantially over time (<6% in 2016 to 40.8% in 2019). Despite increased use of immunotherapy, however, most patients did not remain on treatment for prolonged durations (immunotherapy median duration 2.2 months vs 2.4 months for nonimmunotherapy; P = 0.5). Across most HCRU measures (inpatient admissions, outpatient visits, emergency department visits, and pharmacy claims), 2L+ patients had significantly less utilization per patient compared with 1L patients in unadjusted analyses. CONCLUSIONS: This analysis found that the majority of Medicaid patients with r/mCC received guideline-recommended standard of care in 1L between 2016 and 2019. However, there was no clear standard of care for patients with 2L+ r/mCC enrolled in Medicaid over this time period. Although immunotherapy use is increasing, short durations of treatment suggest a potential unmet medical need among this population. New therapies should provide meaningful clinical benefit without significant increase in HCRU for Medicaid enrollees needing treatment for r/mCC. DISCLOSURES: Dr Leath has received consulting fees from Seagen Inc. for service on Scientific Advisory Boards, cervical cancer research funding from Agenus, Rubius Therapeutics, and Seagen Inc., and funding from the NCI UG1 CA23330 and P50 CA098252. Dr Ting and Dr Zhang are employees and stock owners of Seagen Inc. Mr Fiori and Dr Pauly are current employees and Ms Nysenbaum is a former employee of Manatt Health Strategies, which received funding from Seagen Inc. to conduct the study described here. Manatt Health Strategies has also previously received consulting fees from other pharmaceutical companies that they are not permitted to publicly disclose. This research was funded by Seagen Inc. Seagen Inc. conceptualized the study approach, methodology, and contributed to article writing and review but was not involved in data acquisition, manipulation, or analysis.

Association of polysubstance use disorder with treatment quality among Medicaid beneficiaries with opioid use disorder.

INTRODUCTION: The opioid crisis is transitioning to a polydrug crisis, and individuals with co-occurring substance use disorder (SUDs) often have unique clinical characteristics and contextual barriers that influence treatment needs, engagement in treatment, complexity of treatment planning, and treatment retention. METHODS: Using Medicaid data for 2017-2018 from four states participating in a distributed research network, this retrospective cohort study documents the prevalence of specific types of co-occurring SUD among Medicaid enrollees with an opioid use disorder (OUD) diagnosis, and assesses the extent to which different SUD presentations are associated with differential patterns of MOUD and psychosocial treatments. RESULTS: We find that more than half of enrollees with OUD had a co-occurring SUD, and the most prevalent co-occurring SUD was for "other psychoactive substances", indicated among about one-quarter of enrollees with OUD in each state. We also find some substantial gaps in MOUD treatment receipt and engagement for individuals with OUD and a co-occurring SUD, a group representing more than half of individuals with OUD. In most states, enrollees with OUD and alcohol, cannabis, or amphetamine use disorder are significantly less likely to receive MOUD compared to enrollees with OUD only. In contrast, enrollees with OUD and other psychoactive SUD were significantly more likely to receive MOUD treatment. Conditional on MOUD receipt, enrollees with co-occurring SUDs had 10 % to 50 % lower odds of having a 180-day period of continuous MOUD treatment, an important predictor of better patient outcomes. Associations with concurrent receipt of MOUD and behavioral counseling were mixed across states and varied depending on co-occurring SUD type. CONCLUSIONS: Overall, ongoing progress toward increasing access to and quality of evidence-based treatment for OUD requires further efforts to ensure that individuals with co-occurring SUDs are engaged and retained in effective treatment. As the opioid crisis evolves, continued changes in drug use patterns and populations experiencing harms may necessitate new policy approaches that more fully address the complex needs of a growing population of individuals with OUD and other types of SUD.

Drive Times to Methadone Treatment among Medicaid Patients.

OBJECTIVE: To describe round-trip drive times and travel distance to methadone clinics among Medicaid enrollees in West Virginia, testing for differences between those in rural versus urban areas. FINDINGS: In this cross-sectional analysis of West Virginia Medicaid enrollees' claims from 2018-2019, methadone recipients on average traveled almost an hour round-trip to receive their daily treatment. The travel burden was substantially higher among those in more rural areas. Meaning. These findings indicate that it may be difficult for patients to adhere to their methadone treatment regimen, perhaps leading to suboptimal treatment rates and outcomes.

The SNAP Cycle and Diabetes Management During a One-Time Change in Disbursement Schedule.

OBJECTIVE: The 2018-2019 federal government partial shutdown resulted in a one-time disruption to the usual disbursement schedule of Supplemental Nutrition Assistance Program (SNAP) benefits nationwide. We assessed the relationship between this disruption and hyperglycemia and hypoglycemia medical encounters among beneficiaries with diabetes. RESEARCH DESIGN AND METHODS: To estimate whether the one-time change in benefit disbursement affected the monthly cycle of hyperglycemia or hypoglycemia encounter rates, we used linked administrative Medicaid claims and SNAP disbursement data from West Virginia in a fixed-effects model with interactions between week of the month and the two months of interest-January and February 2019. We controlled for week, month, year, and county effects as well as individual characteristics, and we clustered SEs by individual. RESULTS: We found that the early disbursement of SNAP benefits in January 2019 resulted in a spike in hyperglycemia four times the rate in a typical month. Further, we found a decrease in both hyperglycemia and hypoglycemia in late February. CONCLUSIONS: Our findings suggest that the early distribution of benefits led to a temporary increase in food consumption among West Virginia Medicaid beneficiaries with diabetes. Findings from late February also imply that individuals may have a way to prepare for reduced food resources. These results shed new light on the effects of unexpected changes to the timing of safety net payments as well as an understanding of unintended consequences of government shutdowns.

Underrecognition of sleep-disordered breathing and other common health conditions in the West Virginia Medicaid population: a driver of poor health outcomes.

STUDY OBJECTIVES: To assess the prevalence rates of sleep-disordered breathing (SDB) in a high-risk and rural-dwelling Medicaid population with significant comorbidities. METHODS: Our study analyzed anonymized administrative claims data from West Virginia (WV) Medicaid. Claims data from 2019 were aggregated at the individual level to assess the overall prevalence of SDB and related conditions among adult Medicaid beneficiaries. The prevalence rate of SDB, specifically among individuals who had comorbid congestive heart failure, chronic obstructive pulmonary disease, or obesity, was determined. Finally, we compared our prevalence estimates from this Medicaid database with prevalence rates from national datasets including the Centers for Disease Control and Prevention's Behavioral Risk Factor Surveillance System. RESULTS: Of the total 413,757 Medicaid enrollees ≥ 18 years old analyzed, 36,433 had a diagnosis code of SDB for an overall prevalence of 8.8%. Based on national datasets and our study cohort characteristics, we conservatively estimated the prevalence of SDB in this WV Medicaid population to be 25%. For our secondary analyses, we determined the prevalence of SDB in specific disease cohorts of congestive heart failure (SDB prevalence 45%), chronic obstructive pulmonary disease (SDB prevalence 27%), and obesity (SDB prevalence 14%). CONCLUSIONS: Our analysis of WV Medicaid claims data indicates that SDB and other important medical conditions are underrecognized in this vulnerable, high-risk, primarily rural population. Interestingly, SDB was identified at high rates in the disease cohorts of interest. Our team believes SDB represents an ideal target/model for addressing the growing health disparities in the United States, which is a major concern for all stakeholders in health care. CITATION: Stansbury R, Strollo P, Pauly N, et al. Underrecognition of sleep-disordered breathing and other common health conditions in the West Virginia Medicaid population: a driver of poor health outcomes. J Clin Sleep Med. 2022;18(3):817-824.

Use of Medications for Treatment of Opioid Use Disorder Among US Medicaid Enrollees in 11 States, 2014-2018.

Importance: There is limited information about trends in the treatment of opioid use disorder (OUD) among Medicaid enrollees. Objective: To examine the use of medications for OUD and potential indicators of quality of care in multiple states. Design, Setting, and Participants: Exploratory serial cross-sectional study of 1 024 301 Medicaid enrollees in 11 states aged 12 through 64 years (not eligible for Medicare) with International Classification of Diseases, Ninth Revision (ICD-9 or ICD-10) codes for OUD from 2014 through 2018. Each state used generalized estimating equations to estimate associations between enrollee characteristics and outcome measure prevalence, subsequently pooled to generate global estimates using random effects meta-analyses. Exposures: Calendar year, demographic characteristics, eligibility groups, and comorbidities. Main Outcomes and Measures: Use of medications for OUD (buprenorphine, methadone, or naltrexone); potential indicators of good quality (OUD medication continuity for 180 days, behavioral health counseling, urine drug tests); potential indicators of poor quality (prescribing of opioid analgesics and benzodiazepines). Results: In 2018, 41.7% of Medicaid enrollees with OUD were aged 21 through 34 years, 51.2% were female, 76.1% were non-Hispanic White, 50.7% were eligible through Medicaid expansion, and 50.6% had other substance use disorders. Prevalence of OUD increased in these 11 states from 3.3% (290 628 of 8 737 082) in 2014 to 5.0% (527 983 of 10 585 790) in 2018. The pooled prevalence of enrollees with OUD receiving medication treatment increased from 47.8% in 2014 (range across states, 35.3% to 74.5%) to 57.1% in 2018 (range, 45.7% to 71.7%). The overall prevalence of enrollees receiving 180 days of continuous medications for OUD did not significantly change from the 2014-2015 to 2017-2018 periods (-0.01 prevalence difference, 95% CI, -0.03 to 0.02) with state variability in trend (90% prediction interval, -0.08 to 0.06). Non-Hispanic Black enrollees had lower OUD medication use than White enrollees (prevalence ratio [PR], 0.72; 95% CI, 0.64 to 0.81; P < .001; 90% prediction interval, 0.52 to 1.00). Pregnant women had higher use of OUD medications (PR, 1.18; 95% CI, 1.11-1.25; P < .001; 90% prediction interval, 1.01-1.38) and medication continuity (PR, 1.14; 95% CI, 1.10-1.17, P < .001; 90% prediction interval, 1.06-1.22) than did other eligibility groups. Conclusions and Relevance: Among US Medicaid enrollees in 11 states, the prevalence of medication use for treatment of opioid use disorder increased from 2014 through 2018. The pattern in other states requires further research.

Estimated Medicaid Costs Associated with Hepatitis A During an Outbreak - West Virginia, 2018-2019.

Hepatitis A is a vaccine-preventable disease caused by the hepatitis A virus (HAV). Transmission of the virus most commonly occurs through the fecal-oral route after close contact with an infected person. Widespread outbreaks of hepatitis A among persons who use illicit drugs (injection and noninjection drugs) have increased in recent years (1). The Advisory Committee on Immunization Practices (ACIP) recommends routine hepatitis A vaccination for children and persons at increased risk for infection or severe disease, and, since 1996, has recommended hepatitis A vaccination for persons who use illicit drugs (2). Vaccinating persons who are at-risk for HAV infection is a mainstay of the public health response for stopping ongoing person-to-person transmission and preventing future outbreaks (1). In response to a large hepatitis A outbreak in West Virginia, an analysis was conducted to assess total hepatitis A-related medical costs during January 1, 2018-July 31, 2019, among West Virginia Medicaid beneficiaries with a confirmed diagnosis of HAV infection. Among the analysis population, direct clinical costs ranged from an estimated $1.4 million to $5.6 million. Direct clinical costs among a subset of the Medicaid population with a diagnosis of a comorbid substance use disorder ranged from an estimated $1.0 million to $4.4 million during the study period. In addition to insight on preventing illness, hospitalization, and death, the results from this study highlight the potential financial cost jurisdictions might incur when ACIP recommendations for hepatitis A vaccination, especially among persons who use illicit drugs, are not followed (2).

Healthcare Patterns of Pregnant Women and Children Affected by OUD in 9 State Medicaid Populations.

OBJECTIVES: State Medicaid programs are the largest single provider of healthcare for pregnant persons with opioid use disorder (OUD). Our objective was to provide comparable, multistate measures estimating the burden of OUD in pregnancy, medication for OUD (MOUD) in pregnancy, and related neonatal and child outcomes. METHODS: Drawing on the Medicaid Outcomes Distributed Research Network (MODRN), we accessed administrative healthcare data for 1.6 million pregnancies and 1.3 million live births in 9 state Medicaid populations from 2014 to 2017. We analyzed within- and between-state prevalences and time trends in the following outcomes: diagnosis of OUD in pregnancy, initiation, and continuity of MOUD in pregnancy, Neonatal Opioid Withdrawal Syndrome (NOWS), and well-child visit utilization among children with NOWS. RESULTS: OUD diagnosis increased from 49.6 per 1000 to 54.1 per 1000 pregnancies, and the percentage of those with any MOUD in pregnancy increased from 53.4% to 57.9%, during our study time period. State-specific percentages of 180-day continuity of MOUD ranged from 41.2% to 84.5%. The rate of neonates diagnosed with NOWS increased from 32.7 to 37.0 per 1000 live births. State-specific percentages of children diagnosed with NOWS who had the recommended well-child visits in the first 15 months ranged from 39.3% to 62.5%. CONCLUSIONS: Medicaid data, which allow for longitudinal surveillance of care across different settings, can be used to monitor OUD and related pregnancy and child health outcomes. Findings highlight the need for public health efforts to improve care for pregnant persons and children affected by OUD.

Advances in prescription drug monitoring program research: a literature synthesis (June 2018 to December 2019).

PURPOSE OF REVIEW: Nearly every U.S. state operates a prescription drug monitoring program (PDMP) to monitor dispensing of controlled substances. These programs are often considered key policy levers in the ongoing polydrug epidemic. Recent years have seen rapid growth of peer-reviewed literature examining PDMP consultation and the impacts of these programs on diverse patient populations and health outcomes. This literature synthesis presents a review of studies published from June 2018 to December 2019 and provides relevant updates from the perspective of three researchers in this field. RECENT FINDINGS: The analyzed studies were primarily distributed across three overarching research focus areas: outcome evaluations (n = 29 studies), user surveys (n = 23), and surveillance (n = 22). Identified themes included growing awareness of the unintended consequences of PDMPs on access to opioids, effects on benzodiazepines and stimulant prescribing, challenges with workflow integration across multiple specialties, and new opportunities for applied data science. SUMMARY: There is a critical gap in existing PDMP literature assessing how these programs have impacted psychiatrists, their prescribing behaviors, and their patients. Although PDMPs have improved population-level monitoring of controlled substances from medical sources, their role in responding to a drug epidemic shifting to illicitly manufactured drugs is under scrutiny.

Trends in Gabapentin Prescribing in a Commercially Insured U.S. Adult Population, 2009-2016.

BACKGROUND: Gabapentin is prescribed for a variety of conditions and is often used off label. It is important to understand the prevalence of gabapentin prescribing and the characteristics of individuals who are prescribed gabapentin, given increasing concern regarding its potential for misuse. OBJECTIVES: To (a) examine state- and region-level prevalence and trends in gabapentin prescribing from 2009 to 2016 and (b) characterize demographic and clinical characteristics of individuals prescribed gabapentin in a nationwide population of commercially insured adults. METHODS: This retrospective, longitudinal study examined trends in gabapentin prescribing from 2009 to 2016. The study population included individuals aged 18-64 years who were enrolled in a commercial insurance plan at any point from 2009 to 2016. Individuals who were prescribed gabapentin were defined as beneficiaries with at least 1 gabapentin prescription claim in a calendar year (CY). A cross-sectional descriptive analysis was performed to examine differences in demographic and clinical characteristics of individuals prescribed or not prescribed gabapentin in CY 2016. RESULTS: The prevalence of gabapentin prescribing nearly doubled from 2009 to 2016. During this time, gabapentin prescribing increased in every state (range: 44%-179%). State-specific prevalence rates in 2016 varied from 12.7 to 43.9 per 1,000 beneficiaries. Overall, 2.7% of beneficiaries filled ≥ 1 gabapentin prescription in 2016. Individuals prescribed gabapentin were more likely to fill opioid prescriptions (60.8% vs. 16.5%, P < 0.01); reside in the South (53.7% vs. 47%, P < 0.01); be female (62.5% vs. 52.3%, P < 0.01); and be aged 55-64 years (41.7% vs. 21.2%, P < 0.01) compared with the comparator. Individuals who were prescribed gabapentin also had significantly higher rates of seizure disorders, neuropathic pain, mental health disorders, substance use disorders, and diabetes. CONCLUSIONS: The prevalence of gabapentin prescribing among a U.S. privately insured population has increased steadily in recent years. Additional research should examine coprescribing of gabapentin in the context of the opioid epidemic. DISCLOSURES: The project described in this study was supported by the NIH National Center for Advancing Translational Sciences through grant number UL1TR001998. This study was also partially supported by grant number 2017-PM-BX-K026 (Data-Driven Responses to Prescription Drug Misuse in Kentucky) awarded by the Bureau of Justice Assistance. Viewpoints or opinions in this document are those of the authors and do not necessarily represent the official position or policies of the U.S. Department of Justice or the official views of the NIH. The authors do not have any conflicts of interest to report. Portions of this study have been previously presented in poster presentations at the 2019 Academy Health Annual Research Meeting; June 2-4, 2019; Washington, DC, and the 2019 University of Kentucky Substance Use Research Day; March 3, 2019; Lexington, KY.

Innovative Solutions for State Medicaid Programs to Leverage Their Data, Build Their Analytic Capacity, and Create Evidence-Based Policy.

As states have embraced additional flexibility to change coverage of and payment for Medicaid services, they have also faced heightened expectations for delivering high-value care. Efforts to meet these new expectations have increased the need for rigorous, evidence-based policy, but states may face challenges finding the resources, capacity, and expertise to meet this need. By describing state-university partnerships in more than 20 states, this commentary describes innovative solutions for states that want to leverage their own data, build their analytic capacity, and create evidence-based policy. From an integrated web-based system to improve long-term care to evaluating the impact of permanent supportive housing placements on Medicaid utilization and spending, these state partnerships provide significant support to their state Medicaid programs. In 2017, these partnerships came together to create a distributed research network that supports multi-state analyses. The Medicaid Outcomes Distributed Research Network (MODRN) uses a common data model to examine Medicaid data across states, thereby increasing the analytic rigor of policy evaluations in Medicaid, and contributing to the development of a fully functioning Medicaid innovation laboratory.

Kentucky's Smoking Cessation Quitline: Annual Estimated Return on Investment to Employers.

PURPOSE: State-based smoking cessation telephone quitlines offer a cost-effective method of providing tobacco treatment at no cost to participants. The study objective was to assess the annual return on investment (ROI) to employers if they were to bear the entire responsibility from the Kentucky quitline. DESIGN: A retrospective design was used to estimate the annual ROI to employers from the Kentucky quitline. SETTING: The telephone quitline (1-800-QUIT-NOW) provided intake and follow-up data for all Kentucky participants who enrolled in the program from 2012 to 2014. PARTICIPANTS: All individuals aged 18+ who enrolled in the Kentucky quitline from 2012 to 2014. MEASURES: Successful tobacco cessation was assessed from follow-up surveys that took place after individuals completed the program. Cost savings to employers associated with tobacco cessation were gleaned from a published meta-analysis. The Kentucky quitline provided estimates for annual program expenses. ANALYSIS: The annual ROI was calculated as the difference between estimated annual cost savings due to smoking cessation and annual program expenses. RESULTS: From 2012 to 2014, 5425 individuals were enrolled in the quitline. The annual ROI to employers was estimated to be $998 680, with an ROI ratio of 6.2:1. CONCLUSIONS: Employers may receive a substantial ROI if they were to fund the Kentucky quitline. Study results may be used as evidence to support cost-sharing partnerships between public health agencies and employers to sustain funding for telephone quitlines.

Empirical Assessment of the Impact of Low-Cost Generic Programs on Adherence-Based Quality Measures.

In the United States, federally-funded health plans are mandated to measure the quality of care. Adherence-based medication quality metrics depend on completeness of administrative claims data for accurate measurement. Low-cost generic programs (LCGPs) cause medications fills to be missing from claims data as medications are not adjudicated through a patient's insurance. This study sought to assess the magnitude of the impact of LCGPs on these quality measures. Data from the 2012-2013 Medical Expenditure Panel Survey (MEPS) were used. Medication fills for select medication classes were classified as LCGP fills and individuals were classified as never, sometimes, and always users of LCGPs. Individuals were classified based on insurance type (private, Medicare, Medicaid, dual-eligible). The proportion of days covered (PDC) was calculated for each medication class and the proportion of users with PDC ≥ 0.80 was reported as an observed metric for what would be calculated based on claims data and a true metric which included missing medication fills due to LCGPs. True measures of adherence were higher than the observed measures. The effect's magnitude was highest for private insurance and for medication classes utilized more often through LCGPs. Thus, medication-based quality measures may be underestimated due to LCGPs.

Predictors of Chronic Opioid Use in Newly Diagnosed Crohn's Disease.

BACKGROUND AND AIMS: Patients with Crohn's disease (CD) are often prescribed opioids chronically to manage pain associated with their disease. However, little evidence exists to support this practice. Here, we examine newly diagnosed patients with CD with and without chronic opioid use (COU) and sought to identify predictors and consequences of COU. METHODS: A nationally representative administrative health care claims that data set identified newly diagnosed patients with CD. Their data were examined during the periods 6 months before and 2 years after diagnosis. Multivariable logistic regression was used to assess predictors of COU at diagnosis. RESULTS: The final study cohort consisted of 47,164 patients with CD. Of them, 3.8% were identified with new COU. Chronic opioid users were more likely women, older, and likely who had more surgeries, endoscopies, admissions, and medication usage compared with other patients. Features detected before CD diagnosis that correlated with COU after diagnosis included previous opioid use (odds ratio [OR] = 6.6), chronic pain (OR = 1.36), arthritis (OR = 1.95), and mental disorders (OR = 1.58). Interestingly, emergency department visits before CD Dx increased the risk of COU (OR = 1.11), whereas endoscopy reduced COU risk (OR = 0.88). CONCLUSIONS: This study presents a nationally representative assessment of COU in newly diagnosed patients with CD. The results may be used to determine the impact of COU in this population and to alert clinicians to those patients with CD at high risk of COU. Chronic opioids are consistently associated with indicators of more severe disease; however, additional research is needed to determine whether COU drives disease severity or vice versa.

Low-Cost Generic Program Use by Medicare Beneficiaries: Implications for Medication Exposure Misclassification in Administrative Claims Data.

BACKGROUND: Administrative claims data are used for a wide variety of research and quality assurance purposes; however, they are prone to medication exposure misclassification if medications are purchased without using an insurance benefit. Low-cost generic drug programs (LCGPs) offered at major chain pharmacies are a relatively new and sparsely investigated source of exposure misclassification. LCGP medications are often purchased out of pocket; thus, a pharmacy claim may never be submitted, and the exposure may go unobserved in claims data. As heavy users of medications, Medicare beneficiaries have much to gain from the affordable medications offered through LCGPs. This use may put them at increased risk of exposure misclassification in claims data. Many high-risk medications (HRMs) and medications tracked for adherence and utilization quality metrics are available through LCGPs, and exposure misclassification of these medications may impact the quality assurance efforts reliant on administrative claims data. Presently, there is little information regarding the use of these programs among a geriatric population. OBJECTIVES: To (a) quantify the prevalence of LCGP users in a nationally representative population of Medicare beneficiaries; (b) compare clinical and demographic characteristics of LCGP users and nonusers; (c) assess determinants of LCGP use and medications acquired through these programs; and (d) analyze patterns of LCGP use during the years 2007-2012. METHODS: This study relied on data from the Medical Expenditure Panel Survey (MEPS) from 2007 to 2012. The first 3 objectives were completed with a cohort of individuals in the most recent MEPS panel, while the fourth objective was completed with a separate cohort composed of individuals who participated in MEPS from 2007 to 2012. Inclusion in either study cohort required that individuals were Medicare beneficiaries aged 65 years or greater, used at least 1 prescription drug during their 2-year panel period, and participated in all 5 rounds of data collection during their panel period. MEPS captures medication utilization by surveying individuals on current and previous medication use and verifies this information at the pharmacy level, so prescription fills can be observed irrespective of payment by an insurer or a filed claim. Pharmaceutical utilization was assessed at the individual level for each year of the study period, and LCGP use was recorded as a binary variable for each individual. An LCGP medication fill was identified if the total cost of the drug was paid out of pocket and matched the cost of medications listed on LCGP formularies available from major pharmacy retailers during these years. Cohort demographics and characteristics of interest included age, gender, race, employment status, marital status, family income level, education level, residence in a metropolitan statistical area, geographic region, prescription drug coverage, Medicare type, comorbidities, number of unique medications used, and number of medication fills. Comparisons were made between users and nonusers using chi-square and t-tests. Multivariable logistic regression was used to identify factors associated with LCGP use. RESULTS: From the most recent MEPS panel, 1,861 individuals were included in the study cohort, of which 53.5% were observed to be LCGP users. The 995 LCGP users in this cohort represented over 20 million Medicare beneficiaries who used LCGPs from 2011 to 2012. Significant differences between LCGP users and nonusers existed in terms of race, educational attainment, comorbidity burden, type of Medicare insurance, number of unique medications used, and number of medication fills. Each additional unique medication filled increased the odds of LCGP use by 12% (95% CI = 1.09-1.14). Individuals with insurance in addition to Medicare (i.e., Tricare/Veteran's Affairs or Medicaid) had less than half the odds of using LCGPs compared with those with Medicare or Medicare managed care insurance coverage only. The proportion of LCGP users and the proportion of LCGP fills out of all medications available through LCGPs increased from 2007 to 2012. CONCLUSIONS: There is a high rate of LCGP use among Medicare beneficiaries aged 65 years or greater. Claims-based research and quality assurance programs focusing on the benefits and harms of medications available through these programs are at risk of underestimating the true medication exposure in this population and should account for this possibility in sensitivity analyses. Managed care organizations should incentivize the reporting of LCGP medication use or make adjustments to generic medication benefit structures to more effectively capture true medication exposure. DISCLOSURES: No direct sources of funding were used to conduct this study. Data acquisition was supported by the University of Kentucky Center for Clinical and Translational Science through funding from NIH NCATS grant #UL1TR000117. Brown is the Humana-Pfizer Research Fellow at the Institute for Pharmaceutical Outcomes & Policy at the University of Kentucky College of Pharmacy and is provided salary from these corporations. However, neither company provided any direct funding for the current study nor provided any input or guidance for the design, methods, or drafting of the manuscript. Pauly has no financial disclosures or conflicts of interest. Portions of these results were presented at the 20th International Society for Pharmacoeconomics and Outcomes Research International Meeting; May 16-20, 2015; Philadelphia, Pennsylvania. Study concept and design were primarily contributed by Brown, along with the other authors. Brown took the lead in data collection and interpretation, along with Pauly and Talbert. All authors participated in the writing and revision of the manuscript.

The Prevalence and Predictors of Low-Cost Generic Program Use in a Nationally Representative Uninsured Population.

The uninsured population has much to gain from affordable sources of prescription medications. No prior studies have assessed the prevalence and predictors of low-cost generic drug programs (LCGP) use in the uninsured population in the United States. A cross-sectional study was conducted using data from the Medical Expenditure Panel Survey (MEPS) during 2007-2012 including individuals aged 18 and older who were uninsured for the entire 2-year period they were in MEPS. The proportions of LCGP fills and users was tracked each year and logistic regression was used to assess significant factors associated with LCGP use. A total of 8.3 million uninsured individuals were represented by the sample and 39.9% of these used an LCGP. Differences between users and non-users included higher age, gender, year of participation, and number of medications filled. The proportion of fills and users via LCGPs increased over the 2007-2012 study period. Healthcare providers, especially pharmacists, should make uninsured patients aware of this source of affordable medications.

Prevalence of Low-Cost Generic Program Use in a Nationally Representative Cohort of Privately Insured Adults.

BACKGROUND: Administrative claims data are used for a wide variety of research and quality assurance purposes. Despite their utility, they are prone to medication exposure misclassification if medications are purchased without utilizing an insurance benefit. Low-cost generic programs (LCGPs) offered at major chain pharmacies are a relatively new and sparsely investigated source of exposure misclassification. Since they were implemented in 2006, LCGPs are now available at 8 of the 10 largest pharmacy chains and include a wide variety of medication classes. LCGP medications are often purchased out of pocket; thus, a pharmacy claim may never be submitted and exposure may go unobserved in claims data. There are little data regarding the utilization of these programs, and estimates of their use can provide important insights into the potential impact LCGPs may have on exposure misclassification in claims data. OBJECTIVES: To (a) quantify the prevalence of LCGP users in a privately insured adult population, (b) assess patterns of LCGP use, and (c) compare clinical and demographic characteristics associated with LCGP users and nonusers. METHODS: The study cohort consisted of 19,037 privately insured adults aged 18-64 who participated in the Medical Expenditure Panel Survey (MEPS) from 2007-2011. MEPS captures medication utilization at the pharmacy level, so prescription fills can be observed irrespective of a claim being filed. Pharmaceutical utilization was assessed at the individual level for each year of the study period, and LCGP use was recorded as a binary variable for each individual. An LCGP medication fill was identified if the total cost of the drug was paid out of pocket and matched the cost of medications listed on LCGP formularies available from Target, Walmart, CVS, or other major pharmacy retailers during these years. Cohort demographics and characteristics of interest included age, gender, race, employment status, marital status, family income, education level, residence in a metropolitan statistical area (MSA), prescription drug coverage, geographic region, comorbidities, and number of unique medications and medication fills. Comparisons were made between users and nonusers using chi-square and t-tests. Multivariable logistic regression was used to identify factors associated with LCGP use. RESULTS: Out of the entire study cohort (N = 19,037), 6,921 (36.4%) individuals were identified as LCGP users, representing 34 million LCGP users annually. Users tended to be older, had higher Charlson Comorbidity Index scores, filled more prescriptions per person, and used more unique medications. Proportions of LCGP users and uses nearly doubled from 2007-2011, while total prescription utilization per person remained relatively stable. Over 10% of all prescription fills were filled through LCGPs. Of all LCGP fills, approximately 42% were for cardiovascular medications, 12% for antidiabetics, and 14% for levothyroxine. Greater than 30% of fills for antigout, metronidazole, angiotensin-converting enzyme inhibitors, levothyroxine, metformin, and diuretics were obtained through LCGPs, as were 18.9% of all warfarin fills. Compared with the reference category aged 18-34, adults aged 35-54 had an adjusted odds ratio (AOR) of being an LCGP user of 1.39 (95% CI = 1.29-1.50) and adults aged 55-64 had an AOR of 1.86 (95% CI = 1.70-2.04). Additionally, those with prescription drug coverage were nearly twice as likely to be LCGP users (AOR = 1.96; 95% CI = 1.64-2.35) compared with those without. Gender, income, comorbidity burden, region, year of panel entry, and number of unique medications also significantly predicted LCGP use. CONCLUSIONS: There is a high rate of LCGP use in the privately insured adult population. Users of LCGPs tend to be older, have more chronic comorbidities, and use more medications than nonusers. Claims-based research and quality assurance programs focusing on the benefits and harms of medications available through these programs are at risk of greatly underestimating the true medication exposure in this population and should account for this in sensitivity analyses. Managed care organizations should incentivize the reporting of LCGP medication use or make adjustments to generic medication benefit structures to more effectively capture true medication exposure.