Shellie L. Keast

Strategies aimed at controlling misuse and abuse of opioid prescription medications in a state Medicaid program: a policymaker's perspective

Abstract Society in America, like many others, continues to wrestle with the problem of misuse and abuse of prescription opioids. The implications of this struggle are widespread and involve many individuals and institutions including healthcare policymakers. State Medicaid pharmacy programs, in particular, undergo significant scrutiny of their programs to curtail this problem. While recent efforts have been made by government agencies to both quantify and offer methods for curbing this issue, it still falls to each state’s policymakers to protect its resources and the population it serves from the consequences of misuse and abuse. This paper details the history of one state Medicaid’s management of this issue at the pharmacy benefit level. Examples of various methods employed and the results are outlined and commentary is provided for each method. Regardless of the methods used to address this issue, the problem must still be a priority at all levels, not just for payers.

Evaluation of Abuse-Deterrent or Tamper-Resistant Opioid Formulations on Overall Health Care Expenditures in a State Medicaid Program

BACKGROUND The development of abuse-deterrent opioid prescription medications is a priority at the national level. Pharmaceutical manufacturers have begun marketing new formulations of currently available opioids that meet higher abuse resistance standards. Little information is available regarding the impact of these formulations on overall health care expenditures. OBJECTIVES To (a) examine the relationship between health care expenditures and use of brand abuse-deterrent or tamper-resistant (ADTR) extended-release opioids versus standard dosage form (SDF) extended-release opioids in a state Medicaid population, and (b) determine whether this relationship was influenced by member-specific characteristics. METHODS The study is a cross-sectional review of Oklahoma Medicaid members (aged ≥ 21 years) with at least 1 paid pharmacy claim for long-acting opioids between September 2013 and August 2014. Members who were adherent to extended-release opioid products were classified into ADTR and SDF opioid groups. The relationship between health care expenditures (prescription, medical, and overall) and opioid groups was examined using multiple linear regression models. The impact of member-specific characteristics (age, sex, race, urban classifications, and various comorbidities) on this relationship was examined. RESULTS Prescription spending (

Using prescription monitoring program data to characterize out‐of‐pocket payments for opioid prescriptions in a state Medicaid program

9,265,554) accounted for 35% of overall health care expenditures (

Future economic outlook of Nebraska rural community pharmacies based on break-even analysis of community operational costs and county population

26,304,693) among 938 members during the 12-month reference period. Total prescription expenditures were higher among ADTR than SDF user groups, and the difference in median expenditures between these 2 groups was larger among members with more comorbidities, as measured by the Charlson Comorbidity Index score. Overall, ADTR users had higher median total health care and medical expenditures, and the difference in median expenditures was dependent on whether a member had comorbidities of addiction or not (higher expenditures were observed among members with comorbidities of addiction). CONCLUSIONS The abuse and misuse of medically prescribed opioid products is a growing health epidemic. A variety of attempts have been made to reduce the potential of abuse and misuse of these products, including changes to product formulations. The results of this study indicate that both prescription spending and physician and pharmacy spending combined may be increased with the use of these new products because of higher pricing. Study findings also suggest that the use of ADTR opioids among members with comorbidities of addiction may be related to slightly lower overall health care and medical expenditures than those among members without comorbidities of addiction. Further research is required to answer questions regarding the comparative effectiveness of existing opioid prescription formulations. DISCLOSURES No outside funding supported this research. Nesser is employed by the Oklahoma Health Care Authority, and Keast is a contractual employee for the Oklahoma Health Care Authority. The authors declare no other conflicts of interest. Study design was primarily contributed by Keast, along with Nesser and Farmer. Keast took the lead in data collection, while data interpretation was primarily performed by Owora, along with Keast and assisted by Nesser and Farmer. The manuscript was written and revised by all authors equally.

Prior authorization policies in Medicaid programs: The importance of study design and analysis on findings and outcomes from research

Out‐of‐pocket payment for prescription opioids is believed to be an indicator of abuse or diversion, but few studies describe its epidemiology. Prescription drug monitoring programs (PDMPs) collect controlled substance prescription fill data regardless of payment source and thus can be used to study this phenomenon.

Effect of a High Dosage Opioid Prior Authorization Policy on Prescription Opioid Use, Misuse, and Overdose Outcomes

BACKGROUND There is growing concern over increasingly limited access to local health care, including pharmacies, for rural citizens of the United States. Although geographically distant from most competitors, rural pharmacies may still struggle to generate an acceptable profit to remain economically viable. Therefore, a method for calculating the economic viability for a community pharmacy to recruit a potential new owner to assume the entrepreneurial risk is an important issue to consider when evaluating rural pharmacy access. OBJECTIVES The primary objective of this study was to use a modified break-even analysis to predict the future financial potential of the current pharmacy business to attract a new owner. The secondary objective was to forecast a risk level for a Nebraska county to sustain the number of pharmacies in the country beyond current ownership. METHODS This research used data provided by pharmacies that responded to a Nebraska Medicaid cost of dispensing (COD) survey in addition to data from the US Census Bureau, US Office of Management and Budget, and the Nebraska State Board of Pharmacy. Break-even analysis was used to determine the point where the prescription volume of the pharmacy not only covered the variable and fixed costs but also maintained a reasonable profit to attract new ownership. Counties were classified into 3 risk levels based on the projected available prescription volume and the number of pharmacies in each county. Sensitivity analysis was performed on the risk levels to determine the impact of variance in projected available prescription volume on the projected future outlook for the pharmacies in each county. RESULTS Regression analysis of responses to the COD survey indicated that the annual break-even prescription volume ranged from 44,790 to 49,246 prescriptions per pharmacy per annum. The number of rural Nebraska pharmacies was projected to decline from 126 to 78. The number of counties in Nebraska without a single pharmacy was projected to increase from 19 to 26, and the number of counties with just one pharmacy was projected to increase from 17 to 31. Thus, the number of counties with 1 or no pharmacy was projected to increase to 57 out of the total 93 Nebraska counties. CONCLUSIONS The forecasted closure of pharmacies in rural areas will cause significant portions of the state to be without a pharmacy. Low county populations will be unable to sustain a local prescription volume large enough to remove them from the high risk of pharmacy closure.

The use of think-aloud protocols to identify a decision-making process of community pharmacists aimed at improving CMS Star Ratings scores

U.S. State Medicaid programs for the medically indigent strive to deliver quality health care services with limited budgets. An often used cost management strategy is prior authorization of services or prescription medications. The goal of this strategy is to shape the pharmaceutical market share in the most efficient manner for the particular state Medicaid program, much like commercial managed care organizations. These policies are often scrutinized due to the population Medicaid serves, which in the past was largely composed of individuals with vulnerable health status. Unintended consequences can occur if these policies are not carried out in an appropriate manner or if they greatly restrict services. The data used for policy implementation research is prone to certain problems such as skewness and multimodality. Previous guidelines have been published regarding the best practices when analyzing these data. These guidelines were used to review the current body of literature regarding prior authorization in Medicaid. Further discussed are additional characteristics such as therapeutic areas researched and the outcomes identified. Finally, the importance of considering state-specific characteristics when reviewing individual policies and the usefulness of these results for other programs are also considered.

Does the use of atypical antipsychotics as adjunctive therapy in depression result in cost savings? Comparing healthcare costs and utilization between second-line treatment options

ABSTRACT Background: High dosage opioid use is a risk factor for opioid-related overdose commonly cited in guidelines, recommendations, and policies. In 2012, the Oregon Medicaid program developed a prior authorization policy for opioid prescriptions above 120 mg per day morphine equivalent dose (MED). This study aimed to evaluate the effects of that policy on utilization, prescribing patterns, and health outcomes. Methods: Using administrative claims data from Oregon and a control state (Colorado) between 2011 and 2013, we used difference-in-differences analyses to examine changes in utilization, measures of high risk opioid use, and overdose after introduction of the policy. We also evaluated opioid utilization in a cohort of individuals who were high dosage opioid users before the policy. Results: Following implementation of Oregons high dosage policy, the monthly probability of an opioid fill over 120 mg MED declined significantly by 1.7 percentage points (95% confidence interval [CI]; -2.0% to -1.4%), whereas it increased significantly by 1.0 percentage points (95% CI 0.4% to 1.7%) for opioid fills < 61 mg MED. Fills of medications used to treat neuropathic pain also increased by 1.2 percentage points (95% CI 0.7% to 1.8%). The monthly probability of multiple pharmacy use declined by 0.1 percentage points (-0.2% to -0.0) following the prior authorization, but there were no significant changes in ED encounters or hospitalizations for opioid overdose. Among individuals who were using a high dosage opioid before the policy, there was a 20.3 percentage point (95% CI -15.3% to -25.3%) decline in estimated probability of having a high dosage fill after the policy. Conclusions: Oregons prior authorization policy was effective at reducing high dosage opioid prescriptions. While multiple pharmacy use also declined, we found no impact on opioid overdose were observed.

State Medicaid Programs Bring Managed Care Tenets to Fee for Service

Background: The Center for Medicare and Medicaid Services (CMS) created the Star Rating system based on multiple measures that indicate the overall quality of health plans. Community pharmacists can impact certain Star Ratings measure scores through medication adherence and patient safety interventions. Objective: To explore methods, needs, and workflow issues of community pharmacists to improve CMS Star Ratings measures. Methods: Think‐aloud protocols (TAPs) were conducted with active community retail pharmacists in Oklahoma. Each TAP was audio recorded and transcribed to documents for analysis. Analysts agreed on common themes, illuminated differences in findings, and saturation of the data gathered. Methods, needs, and workflow themes of community pharmacists associated with improving Star Ratings measures were compiled and organized to exhibit a decision‐making process. Five TAPs were performed among three independent pharmacy owners, one multi‐store owner, and one chain‐store administrator. Results: A thematically common 4‐step process to monitor and improve CMS Star Ratings scores among participants was identified. To improve Star Ratings measures, pharmacists: 1) used technology to access scores, 2) analyzed data to strategically set goals, 3) assessed individual patient information for comprehensive assessment, and 4) decided on interventions to best impact Star Ratings scores. Participants also shared common needs, workflow issues, and benefits associated with methods used in improving Star Ratings. Conclusion: TAPs were useful in exploring processes of pharmacists who improve CMS Star Ratings scores. Pharmacists demonstrated and verbalized their methods, workflow issues, needs, and benefits related to performing the task. The themes and decision‐making process identified to improving CMS Star Ratings scores will assist in the development of training and education programs for pharmacists in the community setting. HighlightsPharmacy can impact Star Ratings scores by improving medication adherence and patient safety scores.Pharmacists can improve Star Ratings scores but literature lacks descript methods for this task in the community setting.Five community pharmacists were observed via think‐aloud protocols to identify processes, needs, and workflow issues.A decision‐making process to improve Star Ratings measures was identified from a compilation of themes discovered.Thematic analysis revealed other themes associated with needs, workflow issues, and benefits.

Sustained Virologic Response and Costs Associated with Direct-Acting Antivirals for Chronic Hepatitis C Infection in Oklahoma Medicaid

Abstract Background: Several atypical antipsychotics (AAPs) are used as second-line agents for treatment resistant depression. AAPs can be expensive compared to other treatment options and can cause several side effects. Objectives: To estimate healthcare costs and utilization of AAPs compared to other second-line agents. Methods: Observational study using Medicaid claims data (2006–2011). Subjects were depression-diagnosed adult members with at least two prescriptions of antidepressant medications followed by a second-line agent. Gamma generalized linear models (GLM) produced estimates of the difference in mean expenditures among treatment groups after adjusting for individual baseline characteristics using propensity scores. Negative binomial models produced estimates of the difference in number of hospitalizations and emergency department (ED) visits. Results: A total of 3910 members received second-line treatment. Treatment groups were AAPs (n = 2211), augmentation agents other than AAPs (n = 1008), and antidepressant switching (n = 691). AAPs resulted in higher mean adjusted pharmacy costs and higher mean adjusted total mental health-related costs. Mean adjusted total healthcare costs and number of inpatient and ED visits were not different among treatments. Conclusion: The results show no evidence that AAPs used as second-line treatment for depression results in overall cost savings or lower inpatient and ED visits compared to other treatment strategies.