Readmissions, costs, and duration to subsequent outpatient visit after hospital discharge among Medicaid beneficiaries utilizing oral versus long-acting injectable antipsychotics in bipolar disorder or schizophrenia.

BACKGROUND: Long-acting injectable antipsychotics (LAIs) may reduce hospitalizations versus oral formulations (OAP) in bipolar disorder (BP) and schizophrenia/schizoaffective disorder (SCZ), but the impact on time to outpatient follow-up is less understood. OBJECTIVES: To assess hospital readmissions and medical costs among Medicaid beneficiaries with BP or SCZ utilizing OAP or LAI SGAs. METHODS: Cross-sectional and longitudinal analyses utilized comprehensive administrative claims of Oklahoma Medicaid beneficiaries (≥18 years) with BP or SCZ between 1 January 2013 and 31 December 2017. Readmissions, total direct medical costs, and psychiatry-related outpatient visits were assessed via generalized linear models and generalized estimating equations, controlling for demographic and clinical covariates. RESULTS: Among 2523 included members, LAI utilization was associated with 1.50 and 1.73 times higher odds of any hospitalization and any readmission, respectively (p < .05). Cases involving both BP and SCZ were associated with a 2.40 times higher odds of any readmission, 2.26 times higher number of readmissions, and 24.5% higher costs (p < .001). Of the 468 members with a subsequent psychiatry-related outpatient visit, LAIs were associated with a 23.9% shorter duration to outpatient visit and 16.4% lower costs (p < .05). CONCLUSION: In contrast to prior studies, this real-world investigation noted higher hospitalizations and readmissions among LAIs relative to OAP medications, but among members with a hospitalization or ED visit, LAIs were associated with shorter durations to outpatient visits and lower costs. Those with diagnoses of both BP with SCZ had higher odds of any readmission, number of readmissions, and costs relative to those with bipolar disorder alone and may be a key target for interventions.

This study compared long-acting antipsychotics that were administered by injection (LAIs) to antipsychotic agents taken orally (OAPs) among Medicaid members with bipolar disorder and/or schizophrenia. Readmission to the emergency department (ED) or hospital (within 30 days of a previous visit) and costs were observed to be similar with LAIs relative to OAPs. Among members who went to the hospital, a shorter time to psychiatric follow-up outpatient visit and lower costs were observed among those taking LAIs relative to OAPs.

Characterization of Chronic Multiclass Psychotropic Polypharmacy and Psychotherapy in Foster Care Youth in a State Medicaid Population.

BACKGROUND: Foster youth have higher rates of psychotropic medication use and concurrent multiclass psychotropic polypharmacy compared with nonfoster youth. However, less is known about the extent of multiclass psychotropic polypharmacy after adjusting for patient factors associated with psychotropic medication use OBJECTIVES: To (a) compare psychotropic medication use and psychotherapy use by youth in foster care to those not in foster care in the Oklahoma Medicaid population across various sociodemographic and clinical factors, and (b) determine if patient-related characteristics are associated with high levels of concurrent multiclass psychotropic polypharmacy. METHODS: This cross-sectional, retrospective analysis was conducted using paid prescription, outpatient, and inpatient Oklahoma Medicaid administrative claims from calendar year 2016. Foster youth and adolescents aged 20 years or younger were identified (n = 9,325) and compared with the general Oklahoma Medicaid population of the same age (n = 639,868). Descriptive statistics highlight baseline demographic and clinical differences between the 2 groups. Multivariable logistic regression was used to determine if covariates were associated with concurrent multiclass psychotropic polypharmacy. A subgroup analysis of foster youth taking at least 1 psychotropic medication was also performed to determine factors associated with the highest level of concurrent multiclass psychotropic polypharmacy. RESULTS: Foster care was associated with higher odds of concurrent multiclass psychotropic polypharmacy regardless of presence of psychotherapy. Among the subgroup of foster youth taking at least 1 psychotropic medication, attention deficit hyperactivity disorder medications were the most commonly prescribed medication class, followed by antidepressants and anxiolytics when use was not chronic. However, at the highest level of chronic multiclass psychotropic polypharmacy (4-5 chronic concurrent medications), antipsychotics rose to the top, and anxiolytics were the least likely to be prescribed. Overall, the foster care population had the highest proportion of individuals with concurrent multiclass psychotropic polypharmacy (9.2% vs. 1.9%, P < 0.0001). The highest level of chronic multiclass psychotropic polypharmacy was more likely to occur in males (OR = 1.66, 95% CI = 1.40-1.96) and patients living in group homes (OR = 4.13, 95% CI = 2.02-8.44) or foster homes (OR = 1.66, 95% CI = 1.25-2.19). Being overweight or obese was associated with an 83% higher odds of being at the highest level of concurrent multiclass psychotropic polypharmacy (95% CI = 1.27-2.64). CONCLUSIONS: Despite higher psychotherapy use, high rates of psychotropic medication use and concurrent multiclass psychotropic polypharmacy in foster youth remain a concern for policymakers. Patterns observed at different levels of concurrent multiclass psychotropic polypharmacy may be key to identifying youth who require additional monitoring. Future research exploring factors associated with higher levels of psychotropic concurrent multiclass psychotropic polypharmacy in foster youth can lead to actionable interventions and important policy changes. DISCLOSURES: This project was funded through the CHIP Health Services Initiative. Keast, Tidmore, and Lambert report contractual employment for the Oklahoma Health Care Authority. Nesser is an employee of the Oklahoma Health Care Authority, and Shropshire is an employee of the Oklahoma Department of Human Services. Keast discloses unrelated research grant funding from AbbVie, Amgen, Otsuka, and Purdue Pharma. Tidmore discloses unrelated research grant funding from Amgen and Otsuka. The remaining authors have no relevant disclosures or conflicts of interest to declare. Posters based on this study were presented at AMCP Nexus 2017; October 16-19, 2017; Grapevine, TX, and at the AMCP Annual Meeting 2018; April 23-26, 2018; Boston, MA.

Hepatitis C Direct-Acting Antiviral Treatment Selection, Treatment Failure, and Use of Drug-Drug Interactions in a State Medicaid Program.

BACKGROUND: Newer hepatitis C virus (HCV) treatments often provide high success rates with fewer adverse events, although the extent of all potential drug interactions is not fully known. OBJECTIVE: To assess outcomes of receiving HCV treatment and subsequent sustained virologic response (SVR) based on patient and clinical characteristics, including direct-acting antiviral (DAA) drug-drug interactions (DDIs), in Medicaid members with chronic HCV. METHODS: Comprehensive medical and pharmacy claims and prior authorization data were collected for HCV patients requesting treatment between January 2014 and June 2015. Outcomes of receiving treatment with DAAs and treatment failure based on SVR were analyzed according to demographics, prior/current HCV treatment, severity of DDIs, advancing liver disease, and comorbidities. Multivariable generalized linear models were employed, including a Bayesian sensitivity analysis. RESULTS: Among 3,412 Medicaid members with HCV, 13.6% received DAAs (n = 464), averaging 53.6 ± 10.0 years, with 52.8% female. Multivariable analyses indicated that higher odds of DAA treatment initiation were associated with older age, prior HCV treatment, and advancing liver disease. Some 4.8% of treatment failures occurred among 168 patients with reported SVRs, wherein a 3.218 times higher adjusted odds of treatment failure was associated with concomitant use of medications with DDIs classified as significant or potentially clinically significant by the University of Liverpool HEP Drug Interactions resource (P = 0.001). CONCLUSIONS: In a cohort of state Medicaid members with chronic HCV, a markedly higher adjusted odds of treatment failure was independently associated with DDIs classified as significant or potentially clinically significant, warranting continued inquiry and potential alternate treatments concerning conditions that require their use. DISCLOSURES: This research was funded by an unrestricted research grant by Gilead Sciences. During the course of this study, all authors were either employed by the Oklahoma HealthCare Authority or engaged in contractual work for this employer. Keast, Holderread, and Skrepnek report unrelated research grants from AbbVie, Otsuka, and Amgen. Keast and Skrepnek acknowledge funding from Purdue Pharma for an unrelated research fellowship grant. Posters based on this work were presented at HepDart 2015 on December 6-10, 2015, in Grand Wailea, HI, and at Academy of Managed Care Nexus 2015 on October 26-29, 2015, in Orlando, FL.

Assessment of the effect of an enhanced prior authorization and management program in a United States Medicaid program on chronic hepatitis C treatment adherence and cost.

OBJECTIVES: The market for chronic hepatitis C (HCV) treatment has changed rapidly. New treatments offer high cure rates, fewer adverse effects, and shorter treatments-but also increased costs per therapy. The objective of this study was to compare adherence and cost between HCV patients included in an enhanced prior authorization and management program (PAMP) versus no intervention in Medicaid members undergoing treatment. DESIGN: A retrospective study using longitudinal panel data assessed differences in adherence and costs associated with implementation of the PAMP from the payer perspective. The PAMP included case management, patient education, pharmacy counseling, and medication adherence. Multivariable generalized estimating equations were used to assess associations between program and outcomes. SETTING AND PARTICIPANTS: Patients with HCV enrolled in a state Medicaid program receiving or requesting HCV treatment from January 2014 to November 2015. OUTCOME MEASURES: Outcomes included medication adherence, treatment gaps, and pharmacy and total direct costs after controlling for demographic and clinical factors between those in the PAMP and those in the preintervention period. RESULTS: There were 384 Medicaid members included (156 pre-PAMP, 228 post-PAMP). Overall adherence was high regardless of PAMP intervention, although an adjusted 1.086-fold increase in medication possession ratio (MPR) was observed with the program and a 2.732-fold higher odds of adherence above 80% (P < 0.05). Members in the program had 0.358 times lower adjusted odds of a greater than 3-day treatment gap, and pharmacy-related costs were 0.940 times lower (P < 0.05); no difference was observed in total medical costs (P = 0.333). CONCLUSION: This enhanced Medicaid program was associated with increased adherence to HCV therapy, decreased treatment gaps, and decreased pharmacy-related costs compared with the preintervention period. Because challenges exist if patients fail HCV treatment or if viral resistance emerges, ensuring high adherence and persistence remains key. Continued work is needed to develop and assess enhanced management programs for this population.

Overview of Prescription Opioid Deaths in the Oklahoma State Medicaid Population, 2012-2016.

BACKGROUND: Medicaid members are predisposed to unintentional prescription opioid overdose. However, little is known about their individual risk factors. OBJECTIVES: To describe demographic and clinical characteristics, medical utilization, opioid use, concurrent use of benzodiazepines, risk factors, and substances involved in death for Oklahoma's Medicaid members who died of unintentional prescription opioid poisoning. SUBJECTS: Decedents who were Medicaid eligible in Oklahoma during the year of death, had an opioid recorded in cause of death, and had ≥1 opioid prescription claim between January 1, 2011 and June 30, 2016 were cases. Controls were living Medicaid members and were matched 3:1 to cases through propensity score matching. MEASURES: Demographics, clinical characteristics, and medical/pharmacy utilization were examined in the 12 months before the index date. RESULTS: Of 639 members with fatal unintentional prescription opioid overdoses, 321 had ≥1 opioid prescription claim in the year before death; these were matched to 963 controls. Compared with controls, decedents had significantly greater proportions of nonopioid substance use disorders, opioid abuse/dependence, hepatitis, gastrointestinal bleeding, trauma not involving motor vehicle accidents, nonopioid poisonings, and mental illness disorders. Decedents had significantly higher daily morphine milligram equivalent doses (67.2±74.4 vs. 47.2±50.9 mg) and greater opioid/benzodiazepine overlap (70.4% vs. 35.9%). Benzodiazepines were involved in 29.3% of deaths. CONCLUSIONS: Several comorbidities indicative of opioid use disorder and greater exposure to opioids and concomitant benzodiazepines were associated with unintentional prescription opioid overdose fatalities. Prescribers and state agencies should be aware of these addressable patient-level factors among the Medicaid population. Targeting these factors with appropriate policy interventions and education may prevent future deaths.

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

BACKGROUND: Outcomes involving newer direct-acting antiviral (DAA) hepatitis C virus (HCV) regimens have not been studied extensively among the Medicaid population. OBJECTIVE: To assess clinical (treatment failure) and economic outcomes for chronic HCV-infected Oklahoma Medicaid members following treatment with DAAs and to measure associations with patient, treatment, and clinical characteristics. METHODS: This cross-sectional study used Oklahoma Medicaid pharmacy and medical claims data for adult members who used a newer DAA agent and had reported a successful or failed sustained virological response rate 12 weeks after therapy completion (SVR12) from January 1, 2014, to June 30, 2016. Multivariable logistic and gamma regressions assessed predictors of SVR12 failure and costs controlling for member demographics (i.e., age, sex, race, rural residence); type of DAA and adherence; clinical characteristics (e.g., comorbid conditions, advanced liver disease); and the implementation of changes to a prior authorization program. RESULTS: Of 934 Medicaid members eligible for treatment with DAAs between January 1, 2014, and June 30, 2016, 906 received DAA treatment, 40.6% (368/906) had reported SVR12 outcomes, and 59.4% (n = 538) did not have a reported SVR recorded. Of those with reported SVR12 outcomes, patients were 53.1 ± 9.7 years of age, 51.1% were male, 8.4% had SVR12 failure, and each member had mean costs of $140,283 ± $52,779. Multivariable analyses indicated higher odds of SVR12 failure was independently associated with cirrhosis (OR [decompensated] = 6.69 and OR [compensated] = 3.52, P < 0.001), while males had higher odds of failure than females (OR = 3.34, P < 0.010). No significant difference in SVR12 failure was noted, according to DAA type or a medication adherence threshold of > 95%. Ledipasvir/sofosbuvir was independently associated with lower costs (exp[b] = 0.81; P < 0.001) compared with sofosbuvir, while higher costs were associated with decompensated cirrhosis (exp[b] = 1.22; P < 0.001) and treatment failure (exp[b] = 1.18, P < 0.010). In an analysis including members without reported SVR12 outcomes, decompensated and compensated cirrhosis had lower odds (P < 0.001) of no reported SVR12 from ambulatory clinic settings. CONCLUSIONS: Almost 60% of Medicaid members receiving DAA treatment did not have a final reported SVR12 outcome. Among those with viral load measurements, treatment success was high and both decompensated and compensated cirrhosis were independently associated with significantly higher odds of treatment failure. Addressing a loss to follow-up among HCV patients and curtailing the development of cirrhosis to improve treatment success may warrant interventions that improve access to care and remove barriers that impede treatment initiation and completion. DISCLOSURES: No outside funding supported this study. Pham, Keast, Holderread, Nesser, and Skrepnek disclose either employment by the Oklahoma Health Care Authority or contractual work for this employer. Pham discloses fellowship funding from Purdue Pharma unrelated to this study. Keast and Skrepnek disclose research grant funding from Gilead Sciences and Abbvie. Holderread also reports grant funding from Gilead Sciences and fees from PRIME Education. Thompson, Farmer, and Rathbun have nothing to disclose.

Resource Use Evaluation of Tobramycin Formulations in a State Medicaid Program.

OBJECTIVE: Patients with cystic fibrosis (CF) often suffer from chronic infection with Pseudomonas aeruginosa. For patients with CF, 6 years of age and older, with P aeruginosa persistently present in cultures of the airways, the Cystic Fibrosis Foundation recommends the chronic use of inhaled tobramycin to reduce exacerbations. To ease treatment burden, a new dry powder formulation was developed. The objective of this research was to compare resource utilization between tobramycin inhaled solution (TIS) and a new tobramycin dry powder (TIP) formulation in a state Medicaid program. METHODS: Members that switched from TIS to TIP were matched to TIS-only beneficiaries via propensity score based on age, sex, race, and residence location. The outcomes (tobramycin reimbursement, inpatient hospital reimbursement, additional antibiotic therapy reimbursement, length of inpatient stays, odds of adherence, odds of inpatient hospital stay, and additional mean days of antibiotic therapy) were assessed by using multivariable regression and included baseline clinical surrogates. RESULTS: No difference was found between 54 matched members for tobramycin reimbursement, length of inpatient stays, odds of adherence, or odds of hospital stay. Cost of additional antibiotic therapy was higher for TIP (+$518, p < 0.001) and inpatient reimbursement was higher for TIS (+$503, p = 0.031). Additional mean days of antibiotic therapy were lower for TIP (8.6 vs. 10.1, p = 0.374), but was not statistically significant. CONCLUSIONS: In patients that switched from TIS to TIP, an increase in cost of additional antibiotic therapy was observed, while inpatient costs were lower. Research should be considered in larger populations to fully determine the impact of the new dry powder formulation on overall resource use and outcomes.

Effects of a prior authorization policy for extended-release/long-acting opioids on utilization and outcomes in a state Medicaid program.

BACKGROUND AND AIMS: In response to the opioid overdose epidemic, US state Medicaid programs have adopted restrictive policies for opioid analgesics, yet effects on prescribing patterns and health outcomes are uncertain. This study aimed to examine effects of a prior authorization policy for extended-release/long-acting (ER/LA) opioids on opioid use in the Oklahoma, USA state Medicaid program. DESIGN: Retrospective difference-in-differences design study comparing changes in opioid use in Oklahoma Medicaid to control (Oregon Medicaid). SETTING: Oklahoma and Oregon, USA. PARTICIPANTS: Medicaid beneficiaries in the Oklahoma and Oregon fee-for-service Medicaid programs between July 2007 and June 2009 (33 724 in Oklahoma and 13 520 in Oregon) MEASUREMENTS: The primary outcome was incident opioid-naive ER/LA opioid use. Secondary outcomes included other opioid and non-opioid pain medication use. We also examined indicators of high-risk prescribing (e.g. high-dosage opioid use) and opioid-related hospitalizations or emergency department (ED) visits. FINDINGS: The prior authorization policy was associated with a 0.7 percentage point reduction in the likelihood of incident opioid-naive ER/LA opioid use [95% confidence interval (CI) = -1.16 to -0.33 percentage points; 70% pre-policy mean reduction, a 1.4 percentage point decrease in likelihood of any new ER/LA opioid prescriptions (95% CI = -2.1 to -0.7 percentage points; 33% pre-policy mean reduction) and a decline of 0.16 in total ER/LA opioid prescriptions per enrollee (PPE) (95% CI = -0.29 to -0.04 PPE)]. There was a significant increase in the number of short-acting opioids filled after the policy (0.36; 95% CI = 0.22-0.50 PPE), increases in likelihood of having overlapping opioids and benzodiazepines, but significant reductions in likelihood of having overlapping opioids. No significant changes in opioid-related hospitalizations or ED visits were observed. CONCLUSIONS: In Oklahoma, USA's July 2008 prior authorization policy for extended-release/long-acting opioids appears to have reduced the number of opioid-naive patients initiating extended-release/long-acting opioid use by more than half, but may also have increased short-acting opioid prescriptions by 7%.

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

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.

Community pharmacists' beliefs regarding improvement of Star Ratings scores using the Theory of Planned Behavior.

OBJECTIVES: The Centers for Medicare and Medicaid Services (CMS) is moving toward a value-based model, which includes the Five-Star Quality Rating System (Star Ratings). Prescription Drug Plans include multiple pharmacy measures associated with adherence and patient safety that contribute to CMS Star Ratings scores. This study, using the Theory of Planned Behavior (TPB), explored factors associated with community pharmacists' beliefs to improve Star Ratings scores. DESIGN: Exploratory, qualitative, use of focus groups, and the TPB. SETTING AND PARTICIPANTS: Focus groups were performed in conference rooms at the College of Pharmacy main and satellite campuses. Participants were community retail pharmacists with an active Oklahoma license and 1 year of work experience. MAIN OUTCOME MEASURES: Each focus group was audio recorded and the recording transcribed to documents and analyzed with the use of a hybrid deductive and inductive qualitative approach rooted in a constant comparative framework. Coding of the data back to the TPB constitutes a deductive approach. The generation of themes and subthemes from other coded nodes constitutes an inductive approach. Analysts agreed on common themes, differences in findings, and saturation of the data gathered. RESULTS: Four focus groups were conducted with 26 participants in 2 categories: pharmacists with and without experience improving Star Ratings. Pharmacists shared and contrasted in salient, normative, and control beliefs about patient outcomes, data, financial implications, staff, technology, and other stakeholders associated with performance of improving Star Ratings. Themes regarding medication adherence, patient safety, and intention were also found. CONCLUSION: The TPB was used to explore beliefs of community pharmacists about improving Star Ratings scores. Themes that were identified will assist in future research for measuring intention to improve CMS Star Ratings scores and the development of training and education programs.

Incremental Effect of the Addition of Prescriber Restrictions on a State Medicaid's Pharmacy-Only Patient Review and Restriction Program.

BACKGROUND: Patient review and restriction programs (PRRPs), used by state Medicaid programs to limit potential abuse and misuse of opioids and related controlled medications, often restrict members to a single pharmacy for controlled medications. While most states use a restricted pharmacy access model, not all states include restricted prescriber access. Oklahoma Medicaid (MOK) added a restricted prescriber access feature to its PRRP in July 2014. OBJECTIVE: To evaluate the incremental effect that the addition of a prescriber restriction to MOK's pharmacy-only PRRP had on the pharmacy and resource utilization of the enrolled members. METHODS: MOK members with at least 6 months of enrollment in the pharmacy-only PRRP were restricted to a maximum of 3 prescribers for controlled substances in July 2014 and were identified as "cases." Using a propensity score method, cases were matched to controls from the MOK non-PRRP enrolled population based on demographics and baseline health care utilization. Data from January 1, 2014, through December 31, 2014, were evaluated. Each member's monthly health care resource utilization, defined in terms of medical and pharmacy costs, prescription counts, and opioid use per member per month (PMPM), was analyzed. A difference-indifferences (DID) regression estimated the change in resource utilization following the July 2014 policy change. RESULTS: This study included 378 controls and 126 cases after propensity matching. No differences were noted for daily morphine equivalents, benzodiazepine prescriptions, or maintenance prescriptions. There were decreases in mean PMPM use for both groups for short-acting opioid (SAO) claims (P < 0.001), overall opioid claims (P = 0.007 for controls and P < 0.001 for cases), prescribers (P = 0.01 for controls and P < 0.001 for cases), and number of pharmacies for cases (P < 0.001). DID analyses indicated that cases had a larger decrease in mean SAO claims (difference: -0.15, 95% CI: -0.25 to -0.04, P = 0.008); prescribers (difference: -0.25, 95% CI: -0.36 to -0.15, P < 0.001); and pharmacies (difference: -0.20, 95% CI: -0.28 to -0.13, P < 0.001) relative to controls. The difference for overall opioid claims was greater for cases than controls but did not reach statistical significance (difference: -0.12, 95% CI: -0.25 to 0.00, P = 0.050). CONCLUSIONS: Although there was no evidence that overall opioid claims were affected, the addition of prescriber restrictions may have resulted in an incremental change to SAO, prescriber, and pharmacy use in the PRPP population. Use of PRRPs may be an effective tool in reducing inappropriate use of prescription opioids within payer systems. The question remains whether these changes result in long-term changes to behavior outside the payer system. Future research into the effects of PRRPs on patient behavior beyond the payer system is needed. DISCLOSURES: No outside funding supported this research. All authors disclose either employment by the Oklahoma Health Care Authority or contractual work for this employer. In addition, Keast discloses unrelated funding through unrestricted research grants from Gilead Sciences and Purdue Pharma. Study concept and design were contributed by Keast and Pham, along with Teel and Nesser. Keast and Pham collected the data, along with Teel, and data interpretation was provided by Keast and Pham, with assistance from Teel and Nesser. The manuscript was written primarily by Keast, along with Pham and Teel, and revised by all the authors.

State Medicaid Programs Bring Managed Care Tenets to Fee for Service.

Rising numbers of enrollees in state Medicaid programs have resulted in the increased use of commercial managed care organizations by the states. Research shows that the implementation of these programs has produced mixed results. While many states have implemented managed care principles and have seen reductions in costs, some basic managed care tenets may not apply to a Medicaid population because of limited financial risk and responsibility. The application of commercial managed care organizations to these populations may not result in additional savings for those states already actively engaged in managed care. As such, the purpose of this article is to provide a synopsis of key managed care principles as applied to state Medicaid programs and discuss issues regarding the optimization of cost, access, and quality for this population.

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

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.

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

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.

Impact of a prior authorization policy for montelukast on clinical outcomes for asthma and allergic rhinitis among children and adolescents in a state Medicaid program.

BACKGROUND: Public policymakers often struggle with increased membership and limited budgets. Restrictions, commonly in the form of prior authorizations, are often placed on more costly pharmaceuticals, especially when lower cost or more effective products are available. Restrictions placed on products for difficult-to-manage disease states must be reviewed in order to ensure that unintended clinical consequences do not occur. OBJECTIVE: To assess the impact of a prior authorization policy for montelukast on clinical outcomes for asthma and allergic rhinitis among children and adolescent members of Oklahoma Medicaid (MOK) from 2007 through 2010. METHODS: Monthly individual-level utilization data were collected from MOK paid pharmacy and medical claims from January 1, 2007, through December 31, 2010, for members with asthma and/or allergic rhinitis. Members who were continuously eligible for the entire 48-month review period were included. The effect of a prior authorization policy for montelukast on emergency room (ER) utilization, disease-related physician office visits (DRV), and antibiotic prescription utilization (ABX) was analyzed using segmented logistic regression. RESULTS: For all 3 outcomes, decreases in mean number of claims per member per month were detected when comparing the pre-implementation and post-implementation prior authorization periods for all 3 disease states of asthma, allergic rhinitis, or both. Odds of having an ER event at the point of prior authorization implementation were 0.71 (P less than 0.001) and were 1.29 (P less than 0.001) and 1.26 (P less than 0.001) for DRV and ABX, respectively. Overall trend in odds was 1.02 (P less than 0.001), 0.93 (P less than 0.001), and 0.95 (P less than 0.001) for ER, DRV, and ABX, but during the post-implementation period, the odds were 0.92 (P less than 0.001) for ER and 1.03 (P less than 0.001) for both DRV and ABX. The final result was an increasing trend prior to implementation for ER, a decrease at implementation, and a continued decrease in odds of an event in the post-implementation period. However, for DRV and ABX, there was an overall decrease in trend regardless of period, with a small increase in odds at the point of implementation. CONCLUSIONS: While there was a point increase at implementation for DRV and ABX, the overall trend remained negative, indicating that no unexpected adverse clinical outcomes occurred. Additionally, no signal was found in ER use after implementation to indicate that unintended consequences occurred, particularly for those patients with asthma.

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

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.