Telehealth Clinical Appropriateness and Quality.

Contrary to common perception, telehealth is not simply a substitute for in-person care. With an array of modalities-live audio-video, asynchronous patient communication, and remote patient monitoring, to name a few-telehealth creates entirely new avenues of care delivery (Table 1). Although our current care model is reactive-relying on episodic visits to an office or hospital-telehealth allows us to be proactive, filling in the gaps to provide a continuum of care. Widespread uptake of telehealth has created fertile ground for long-overdue health system reform. In this study, we describe essential next steps: redefine telehealth clinical appropriateness, evolve payment models, provide necessary training, and reimagine the patient-physician interaction.

Assessment of Unmet Health-Related Social Needs Among Patients With Mental Illness Enrolled in Medicare Advantage.

Importance: A large body of literature has found associations between unmet health-related social needs (HRSNs) and adverse mental health outcomes. A comparative analysis of the risks associated with HRSNs among patients with varying severity of mental illness and an assessment of how these risks compare with those of individuals without mental illness are needed. Objective: To examine the prevalence and risks of HRSNs among patients with serious and persistent mental illness (SPMI), patients with mental health diagnoses but no serious and persistent mental illness (non-SPMI), and patients with both SPMI and non-SPMI compared with individuals without mental illness. Design, Setting, and Participants: This retrospective cohort study used data from the Accountable Health Communities HRSN Screening Tool surveys, which target a nationally representative sample of Medicare Advantage members of a large payer (Humana Inc). The surveys were conducted between October 16, 2019, and February 29, 2020. Of the initial 329 008 eligible Medicare Advantage enrollees, 70 273 responded to the survey (21.4% response rate). Of those, 56 081 respondents (79.8%) had complete survey responses and were included in the final analytic sample. Main Outcomes and Measures: Outcomes of interest included 7 HRSNs (financial strain, food insecurity, housing instability, housing quality, severe loneliness, transportation problems, and utility affordability) based on responses to the survey. The major independent variable was the presence of mental illness up to 12 months preceding the date of survey completion. Codes indicating mental illness listed as the primary, principal, or secondary diagnoses of a patient's inpatient or outpatient medical claims data were identified, and participants were grouped into 4 cohorts: SPMI, non-SPMI, SPMI plus non-SPMI, and no mental illness. Results: Among 56 081 older adults, the mean (SD) age was 71.31 (8.59) years; 32 717 participants (58.3%) were female, and 43 498 (77.6%) were White. A total of 21 644 participants (38.6%) had at least 1 mental illness diagnosis in the past year, 30 262 (54.0%) had an HRSN, and 14 163 (25.3%) had both mental illness and an HRSN. Across all specific HRSNs, the odds of experiencing the respective HRSN was most substantial for those with SPMI plus non-SPMI vs those with only non-SPMI or SPMI. The HRSN with the largest risk differences among the study cohorts was severe loneliness; compared with the cohort without mental illness, the non-SPMI cohort had 2.07 times higher odds (95% CI, 1.84-2.32; P < .001), the SPMI cohort had 3.35 times higher odds (95% CI, 3.03-3.71; P < .001), and the SPMI plus non-SPMI cohort had 5.13 times higher odds (95% CI, 4.68-5.61; P < .001) of severe loneliness. Conclusions and Relevance: In this study, the increased risk of having HRSNs associated with SPMI, alone or in combination with non-SPMI, emphasizes the need for more targeted interventions to address social needs in this vulnerable population.

Remote Care Management for Older Adult Populations With Elevated Prevalence of Depression or Anxiety and Comorbid Chronic Medical Illness: A Systematic Review.

BACKGROUND: Comorbidity of psychiatric and medical illnesses among older adult populations is highly prevalent and associated with adverse outcomes. Care management is a common form of outpatient support for both psychiatric and medical conditions in which assessment, care planning, and care coordination are provided. Although care management is often remote and delivered by telephone, the evidence supporting this model of care is uncertain. OBJECTIVE: To perform a systematic review of the literature on remote care management programs for older adult populations with elevated prevalence of depression or anxiety and comorbid chronic medical illness. METHODS: A systematic review was performed in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A multidatabase search was performed. Articles were included for review if they studied fully remote care management for older adult populations with elevated prevalence of depression or anxiety and chronic medical illness or poor physical health. A narrative synthesis was performed. RESULTS: A total of 6 articles representing 6 unique studies met inclusion criteria. The 6 studies included 4 randomized controlled trials, 1 case-matched retrospective cohort study, and 1 pre-post analysis. Two studies focused on specific medical conditions. All interventions were entirely telephonic. Five of 6 studies involved an intervention that was 3 to 6 months in duration. Across the 6 studies, care management demonstrated mixed results in terms of impact on psychiatric outcomes and limited impact on medical outcomes. No studies demonstrated a statistically significant impact on health care utilization or cost. CONCLUSIONS: Among older adult populations with elevated prevalence of depression or anxiety and comorbid chronic medical illness, remote care management may have favorable impact on psychiatric symptoms, but impact on physical health and health care utilization is uncertain. Future research should focus on identifying effective models and elements of remote care management for this population, with a particular focus on optimizing medical outcomes.

Diagnostic accuracy of the repeatable battery of the assessment of neuropsychological status update, Spanish version, in predicting Alzheimer's disease among Hispanic older adults in the United States reporting memory problems.

OBJECTIVES: There are few standardized, Spanish-language diagnostic tools to help identify Hispanic persons at early stages of Alzheimer's disease (AD). This study evaluated the accuracy of the Spanish version of the Repeatable Battery for the Assessment of Neuropsychological Status-Update (RBANS) in predicting AD in older Hispanic adults in the United States reporting memory problems. METHODS: We analyzed data from age, sex, and education level propensity score-matched Hispanic memory clinic patients with (n = 38) and without (n = 38) a clinical diagnosis of AD. Estimates of diagnostic accuracy included sensitivity, specificity, predictive value, and receiver operating characteristic analysis. RESULTS: After controlling for sex and matched pairs, the Total Scale score [area under curve (AUC) = 0.7417] and the Immediate (AUC = 0.7258) and Delayed (AUC = 0.7735) Memory index scores provided better estimates of diagnostic accuracy than Language, Attention, and Visuospatial/Constructional index scores. A minus 2-standard deviation (SD) cut point enhanced the predictive probability of the Delayed Memory index score. A cut point of -1.5 SD optimized the predictive probability of the Total Scale score. CONCLUSIONS: These results suggest that optimal cutoff values for the RBANS Delayed Memory index and Total Scale scores that may help identify Hispanic patients with AD as part of a comprehensive diagnostic AD assessment.

Characteristics of Parkinson's Disease in Patients with and without Cognitive Impairment.

BACKGROUND: Characterizing patients with Parkinson's disease (PD) and cognitive impairment is important toward understanding their natural history. OBJECTIVE: Understand clinical, treatment, and cost characteristics of patients with PD pre- and post-cognitive impairment (memory loss/mild cognitive impairment/dementia or dementia treatment) recognition. METHODS: 2,711 patients with PD newly diagnosed with cognitive impairment (index) were identified using administrative claims data. They were matched (1:1) on age and gender to patients with PD and no cognitive impairment (controls). These two cohorts were compared on patient characteristics, healthcare resource utilization, and total median costs for 3 years pre- and post-index using Chi-square tests, t-tests, and Wilcoxon rank-sum tests. Logistic regression was used to identify factors predicting cognitive impairment. RESULTS: Comorbidity indices for patients with cognitive impairment increased during the 6-year study period, especially after the index. Enrollment in Medicare Advantage Prescription Drug plans vs. commercial (OR = 1.60), dual Medicare/Medicaid eligibility (OR = 1.36), cerebrovascular disease (OR = 1.24), and PD medication use (OR = 1.46) were associated with a new cognitive impairment diagnosis (all p < 0.05). A greater proportion of patients with cognitive impairment had hospitalizations and emergency department visits and higher median total healthcare costs than controls for each year pre- and post-index. CONCLUSION: In patients with PD newly diagnosed with cognitive impairment, comorbidity burden, hospitalizations, emergency department visits, and total costs peaked 1-year pre- and post-identification. These data coupled with recommendations for annual screening for cognitive impairment in PD support the early diagnosis and management of cognitive impairment in order to optimize care for patients and their caregivers.

Spontaneous Spinal Epidural Hematoma: An Atypical Clinical Presentation and Discussion of Management.

INTRODUCTION: Spontaneous spinal epidural hematoma (SSEH) is a rare but potentially devastating condition if not appropriately identified and managed. A few case series exist regarding SSEH and certain risk factors have been described; however, much continues to be unknown regarding the pathophysiology and optimal management. CASE PRESENTATION: We present the case of SSEH in a healthy 33-year-old African American woman with no identifiable risk factors who initially presented with significant neurologic compromise. This case reports discusses pertinent clinical presentation, imaging findings, and surgical management. The patient demonstrated near-complete neurologic recovery, highlighting the need for prompt identification and intervention. CONCLUSIONS: We believe this case adds to the limited literature surrounding the topic, particularly in regard to diagnosis and surgical management. It is essential for clinicians to be cognizant of SSEH for timely diagnosis and treatment, even in patients without obvious risk factors.

Metabolic Monitoring Rates of Youth Treated with Second-Generation Antipsychotics in Usual Care: Results of a Large US National Commercial Health Plan.

Objectives: To examine metabolic monitoring rates in commercially insured children and adolescents treated with a second-generation antipsychotic (SGA) during calendar years (CYs) 2016 and 2017. Methods: In this retrospective study, data were collected from a large national commercial health plan for the period covering January 1, 2016 to December 31, 2017. Commercially insured children and adolescents, aged 8-19 years with ≥2 SGA prescription claims during the CY, were identified for the CY2016 and CY2017 cohorts. The primary outcome of interest was the percentage of subjects with any glucose or lipid metabolism parameter monitoring. Other calculated metabolic testing rates included glucose, hemoglobin A1c (HbA1c), low-density lipoprotein cholesterol (LDL-C), other cholesterol (including triglycerides), and combined glucose and lipid metabolism testing (≥1 test for blood glucose or HbA1c and ≥1 test for LDL-C or other cholesterol). Results: In CY2016 and CY2017, 1502 and 1239 subjects, respectively, were identified for this study. The most common psychiatric diagnoses in CY2016 and CY2017 were major depressive disorder (57.1%, 56.5%, respectively), anxiety disorders (42.9%, 47.5%), attention-deficit/hyperactivity disorder (41.6%, 45.8%), and bipolar disorder (24.1%, 25.9%). The rate of any metabolic testing was 53.5% in CY2016 and 51.3% in CY2017. Glucose testing (50.3%, 46.9%, respectively) was most common in both CYs, followed by LDL-C testing (31.2%, 28.5%). Rates of combined glucose and lipid metabolism testing were 30.7% in CY2016 and 26.9% in CY2017. Conclusions: Given the known potential for adverse cardiometabolic effects, rates of metabolic monitoring associated with SGA use in children and adolescents urgently need to be improved. There is a critical need for understanding barriers to routine monitoring, particularly of lipids, and developing interventions to enhance metabolic monitoring.

Current Trends in Clinical Practice for the Direct Anterior Approach Total Hip Arthroplasty.

BACKGROUND: Despite increased popularity of the direct anterior approach (DAA) for total hip arthroplasty (THA), current practice trends and specific driving factors leading to adoption are not well established. METHODS: We conducted an electronic e-mail survey of members of the American Association of Hip and Knee Surgeons inquiring into the choice of THA surgical approach, perceptions of clinical outcomes, and economic implications associated with the DAA. RESULTS: Of 996 total respondents (44.3% American Association of Hip and Knee Surgeons member response rate), 56.2% currently perform the DAA. DAA performers have been in practice for statistically less time than non-performers (17.0 years vs 20.9 years, P < .001). Similarly, high-volume DAA surgeons have been in practice for less time than low-volume surgeons. DAA performers felt that revision case status (79.3%), complex anatomy (65.0%), and body habitus (53.0%) were factors leading to preferential use of the posterior approach. We also provide comprehensive data for perceived outcomes comparing the DAA and posterior approach. For current non-performers, the top reasons for not utilizing the DAA were feelings of worse outcomes, no clinical benefit, and concern for the learning curve. Economically, 76.1% of DAA performers reported increased patient market share by performing the DAA while 65.8% of non-performers endorsed lost patient market share. Only 3.0% of current non-performers plan to adopt the DAA in the future. CONCLUSION: This is the first study of its kind to highlight current trends and clinical practices from a surgeon perspective regarding the DAA. Specifically, it provides comprehensive data regarding perceptions of clinical outcomes, practice economics, and driving factors for choice of surgical approach for surgeons who do and do not perform the DAA.

Intrawound vancomycin in primary hip and knee arthroplasty: a safe and cost-effective means to decrease early periprosthetic joint infection.

BACKGROUND: Periprosthetic joint infection (PJI) is a devastating complication after hip and knee arthroplasty. Intrawound vancomycin has been described extensively in the spine literature; however, information regarding use in arthroplasty is limited. We investigate the efficacy and safety of intrawound vancomycin in arthroplasty surgery. METHODS: All primary total hip and knee arthroplasty cases (n = 460) performed by a single surgeon from April 2016 to October 2017 were reviewed. Starting in October 2016, intrawound vancomycin was used in all total joints. Baseline characteristics, infection rates, 90-day readmission, and other complications were compared between untreated subjects and those who received intrawound vancomycin. In addition, cost data were considered. Mean follow-up durations for the control and vancomycin groups were 11.3 and 7.7 months, respectively. RESULTS: Baseline characteristics and comorbidities were similar for the control (n = 112) and vancomycin groups (n = 348). The vancomycin cohort demonstrated decreased both overall infection rate (0.57% vs 2.7%; P = .031) and PJI rate (0.29% vs 2.7%; P = .009) compared with the untreated group. There was no statistical difference in incidence of ototoxicity or acute kidney injury. Although there was no difference in overall 90-day readmission rate, the vancomycin subset demonstrated lower readmission rate due to infection (0.57% vs 2.7%; P = .031). Based on the cost of vancomycin powder and calculated number needed to treat (NNT = 47.5), the cost to prevent 1 infection with the addition of intrawound vancomycin was $816. CONCLUSIONS: These findings suggest that intrawound vancomycin may be a safe, cost-effective means that shows promise in reducing PJI in early follow-up. Future prospective studies are warranted.

Postoperative Thrombotic Thrombocytopenic Purpura after Total Hip Arthroplasty: A Case Report and Review of the Literature.

Thrombotic thrombocytopenic purpura (TTP) is an uncommon and potentially lethal microangiopathy that carries a >90% mortality rate if not treated urgently and appropriately. Postoperative TTP after orthopaedic procedures is particularly rare with only four case reports existing in the literature. We present the case of postoperative TTP in a 57-year-old female who underwent elective total hip arthroplasty. We believe this case adds to the limited literature surrounding the topic. While rare, TTP after orthopaedic procedures poses a real and potentially fatal condition if not managed appropriately. Therefore, it is essential for orthopaedic surgeons to be cognizant of postoperative TTP for timely diagnosis and treatment.

Mobility for All?

Substantial numbers of children and adolescents are treated with second-generation antipsychotic medications (SGAs), and the cardiometabolic adverse effects of this medication class have raised concerns.1 In the October 2017 issue of the Journal, Handen et al.2 published a 16-week open-label extension study of youth 6 to 17 years of age with autism spectrum disorder treated with liquid metformin after a 16-week double-blinded, placebo-controlled clinical efficacy trial. The acute-phase and open-label extension trials demonstrated that liquid metformin was well tolerated, and significant improvements in body mass index z-scores were observed in the metformin-metformin and placebo-metformin groups.2 Handen et al.2 concluded that metformin can be effective for decreasing weight gain associated with SGA use and maintaining prior improvement in children and adolescents with autism spectrum disorder.

Retrospective assessment of patient characteristics and healthcare costs prior to a diagnosis of Alzheimer's disease in an administrative claims database.

BACKGROUND: The objective of this study was to examine patient characteristics and health care resource utilization (HCRU) in the 36 months prior to a confirmatory diagnosis of Alzheimer's disease (AD) compared to a matched cohort without dementia during the same time interval. METHODS: Patients newly diagnosed with AD (with ≥2 claims) were identified between January 1, 2013 to September 31, 2015, and the date of the second claim for AD was defined as the index date. Patients were enrolled for at least 36 months prior to index date. The AD cohort was matched to a cohort with no AD or dementia codes (1:3) on age, gender, race/ethnicity, and enrollment duration prior to the index date. Descriptive analyses were used to summarize patient characteristics, HCRU, and healthcare costs prior to the confirmatory AD diagnosis. The classification and regression tree analysis and logistic regression were used to identify factors associated with the AD diagnosis. RESULTS: The AD cohort (N = 16,494) had significantly higher comorbidity indices and greater odds of comorbid mental and behavioral diagnoses, including mild cognitive impairment, mood and anxiety disorders, behavioral disturbances, and cerebrovascular disease, heart disease, urinary tract infections, and pneumonia than the matched non-AD or dementia cohort (N = 49,482). During the six-month period before the confirmatory AD diagnosis, AD medication use and diagnosis of mild cognitive impairment, Parkinson's disease, or mood disorder were the strongest predictors of a subsequent confirmatory diagnosis of AD. Greater HCRU and healthcare costs were observed for the AD cohort primarily during the six-month period before the confirmatory AD diagnosis. CONCLUSION: The results of this study demonstrated a higher comorbidity burden and higher costs for patients prior to a diagnosis of AD in comparison to the matched cohort. Several comorbidities were associated with a subsequent diagnosis of AD.

Transcapsular Buttonholing of the Proximal Ulna as a Cause for Irreducible Pediatric Anterior Elbow Dislocation.

Anterior elbow dislocations in the pediatric population represent rare and sometimes difficult injuries to manage. Associated olecranon fractures are even more uncommon with limited literature existing on the topic. We present the case of a six-year-old male with a traumatic transolecranon anterior elbow fracture dislocation in whom closed reduction was prevented by buttonholing of the proximal ulna through the anterior joint capsule. This case of pediatric anterior elbow fracture dislocation provides insight into an uncommon and challenging injury complex.

The Achilles Tendon in Healthy Subjects: An Anthropometric and Ultrasound Mapping Study.

Ultrasonography is an inexpensive, fast, and reliable imaging technique widely used to assess the Achilles tendon. Although significant data exists regarding pathologic tendon changes, ultrasound data from healthy individuals are more limited. We aimed to better characterize ultrasound Achilles tendon measurements in healthy individuals and identify important correlating factors. The information collected included patient demographics, body habitus, activity level, foot dominance, and resting ankle angle. Ultrasound analysis was performed bilaterally on the Achilles tendons of 50 subjects using a high-frequency transducer to measure tendon width, thickness, cross-sectional area, and length. Males had a significantly larger mean tendon length, width, thickness, and cross-sectional area. No statistically significant difference was found in any tendon dimension between the white and black participants. Similarly, no difference was found in any tendon parameter when comparing right versus left leg dominance. Healthy subjects had a mean ankle resting angle of 45.1° ± 24° with no statistically significant difference between right and left ankles. Considering all individuals, each tendon parameter (tendon length, width, thickness, and cross-sectional area) correlated positively with subject height, weight, tibia length, and foot size. Only the Achilles cross-sectional area correlated significantly with the activity level. The resting angle of the ankle correlated positively with both tendon length and thickness. In conclusion, we found significant variations in Achilles tendon anatomy in the healthy adult population. We have thoroughly characterized significant correlations between healthy tendon dimensions and various body habitus, activity levels, and ankle parameters. Greater knowledge of the normal Achilles tendon anatomy and characterization of its variations in the healthy population will potentially allow for better pathologic diagnosis and surgical repair.

Educational intervention for physicians to address the risk of opioid abuse.

OBJECTIVE: To evaluate the impact of a pilot intervention for physicians to support their treatment of patients at risk for opioid abuse. SETTING, DESIGN AND PATIENTS, PARTICIPANTS: Patients at risk for opioid abuse enrolled in Medicare plans were identified from July 1, 2012 to April 30, 2014 (N = 2,391), based on a published predictive model, and linked to 4,353 opioid-prescribing physicians. Patient-physician clusters were randomly assigned to one of four interventions using factorial design. INTERVENTIONS: Physicians received one of the following: Arm 1, patient information; Arm 2, links to educational materials for diagnosis and management of pain; Arm 3, both patient information and links to educational materials; or Arm 4, no communication. MAIN OUTCOME MEASURES: Difference-in-difference analyses compared opioid and pain prescriptions, chronic high-dose opioid use, uncoordinated opioid use, and opioid-related emergency department (ED) visits. Logistic regression compared diagnosis of opioid abuse between cases and controls postindex. RESULTS: Mailings had no significant impact on numbers of opioid or pain medications filled, chronic high-dose opioid use, uncoordinated opioid use, ED visits, or rate of diagnosed opioid abuse. Relative to Arm 4, odds ratios (95% CI) for diagnosed opioid abuse were Arm 1, 0.95(0.63-1.42); Arm 2, 0.83(0.55-1.27); Arm 3, 0.72(0.46-1.13). While 84.7 percent had ≥1 psychiatric diagnoses during preindex (p = 0.89 between arms), only 9.5 percent had ≥1 visit with mental health specialists (p = 0.53 between arms). CONCLUSIONS: Although this intervention did not affect pain-related outcomes, future interventions involving care coordination across primary care and mental health may impact opioid abuse and improve quality of life of patients with pain.

Outcomes of ACL Reconstruction With Fixed Versus Variable Loop Button Fixation.

Suspensory femoral fixation of anterior cruciate ligament (ACL) grafts with fixed loop button and variable loop button devices has gained popularity for ACL reconstruction. This study examined these 2 methods of fixation to determine their effect on graft laxity and patient-reported outcome scores. A database search was performed to identify patients who had undergone ACL reconstruction with either a fixed loop or a variable loop button technique performed by the primary surgeon. Lysholm, Tegner, and 12-Item Short Form Health Survey scores were obtained, and KT-1000 knee ligament arthrometer (MEDmetric, San Diego, California) mechanical knee testing was performed. Results were compared with the uninjured knee. Of the 112 patients who were identified, 91 met the study criteria. Of these patients, 57 completed KT-1000 knee testing, 33 in the variable group and 24 in the fixed group. The average KT-1000 value for the variable group was 0.38 mm, and the average for the closed group was 0.92 mm (P=.19; 95% confidence interval, -0.28 to 1.35). Among the 19 patients in the variable group and the 13 in the closed group who completed the subjective outcomes questionnaires, no statistically significant difference was found. Clinically lax knees (KT-1000>3 mm) were found in 6.1% and 12.5% of patients in the variable group and the fixed group, respectively (P=.2). The variable group had a rerupture rate of 4.7%, whereas the fixed group had a rerupture rate of 8.7% (P=.21). The study found no statistical difference in ACL graft laxity or postoperative functional outcomes between grafts fixed with the variable loop or fixed loop button technique. [Orthopedics. 2017; 40(2):e275-e280.].

Medicaid insurance is associated with larger curves in patients who require scoliosis surgery.

Children with Medicaid may have difficulty accessing care for adolescent idiopathic scoliosis (AIS), a condition that may worsen with time. We conducted a study to determine whether patients with Medicaid present with a larger curve magnitude. We reviewed the cases of consecutive AIS patients treated with posterior spinal fusion (PSF) between 2008 and 2012. Children seen for second opinions were excluded. Medical records were evaluated to determine time from evaluation to determination for surgery, time from recommendation for surgery to actual procedure, and insurance status. Radiographs were reviewed to determine Cobb angle at initial presentation. Of the 135 patients who underwent PSF for newly diagnosed AIS, 39% had Medicaid insurance. Compared with private insurance patients, Medicaid patients presented with a larger mean (SD) Cobb angle, 57.2° (15.7°) versus 47.5° (14.3°) (P < .001), and had larger curves at time of surgery, 60.6° (13.9°) versus 54.6° (11.7°) (P = .008). There was no difference in wait time from the decision to undergo surgery to the actual surgery or in mean (SD) number of levels fused, 10.3 (2.2) for Medicaid patients versus 9.7 (2.3) for private insurance patients (P = .16). Compared with private insurance patients, Medicaid patients who underwent PSF for AIS had larger presenting Cobb angles and larger Cobb angles at time of surgery.

Impact of a Step Therapy for Guanfacine Extended-Release on Medication Utilization and Health Care Expenditures Among Individuals Receiving Treatment for ADHD.

BACKGROUND: While step therapy (ST) policies are generally effective at reducing cost through the managed utilization of targeted medications, the clinical implications of ST policies are not clear and may vary across therapeutic areas. Guanfacine extended-release (GXR) is approved by the FDA for the treatment of attention-deficit/hyperactivity disorder (ADHD) as both monotherapy and adjunctive to stimulant treatment. At the introduction of GXR to the market, Humana implemented an ST policy on GXR requiring the documentation of previous treatment, intolerance, or contraindication to generic clonidine or guanfacine. OBJECTIVE: To examine the impact of a GXR ST coverage determination (i.e., approved vs. denied) on medication utilization and health care costs among members of a commercial health plan with an ST policy for GXR.  METHODS: This study was a retrospective cohort study of administrative claims data. Humana commercial members prescribed GXR who had an ST coverage determination review were identified. All members included in this analysis were required to be aged 6-17 years, have a diagnosis of ADHD or be receiving stimulant medication, have an ST coverage determination (index event) between September 1, 2009, and May 30, 2012, and have 6 months of pre- and post-index continuous enrollment. Members were assigned to either the approved or denied group based on the outcome of the ST coverage determination. Medical and pharmacy claims data were used to measure baseline demographic and clinical characteristics and to measure medication utilization and health care costs. Outcomes assessed during follow-up included ADHD medication use, proportion of days covered (PDC) with any ADHD medication treatment, time to first observed post-index ADHD treatment, and all-cause and mental health (MH)-related health care costs. Administrative costs associated with the coverage determination process were also estimated. Bivariate and multivariable adjusted analyses were conducted to compare medication utilization and health care costs between the approved and denied groups. RESULTS: A total of 642 members were included in the analysis (denied group n = 395 [61.5%], approved group n = 247 [38.5%]). The approved and denied groups were similar in terms of baseline demographics, provider characteristics, and baseline MH diagnoses, with the exception of anxiety disorders being more prevalent in the approved group compared with the denied group (18.2% vs. 10.6%, P = 0.006). A denied GXR coverage determination was associated with a greater percentage of members receiving no ADHD treatment post-index (13.9% vs. 3.2%, P less than 0.001), greater mean [SD] number of days between index and first observed post-index ADHD medication claim (44.5 [59.6] vs. 17.6 [33.4], P less than 0.001), and lower mean [SD] PDC with any ADHD medication post-index (0.59 [0.33] vs. 0.75 [0.26], P less than 0.001). These findings remained statistically significant in multivariable regression models. Unadjusted pre-index median total health care costs and MH-related costs were greater among the approved group compared with the denied group (total health care: $1,582 vs. $1,465, P = 0.033; MH-related: $993 vs. $981, P = 0.020). Likewise, post-index median total health care and MH-related costs were greater among the approved group compared with the denied group (total: $2,056 vs. $1,420, P less than 0.001; MH-related: $1,543 vs. $946, P less than 0.001). After adjustment for potentially confounding covariates including pre-index costs, there were no statistically significant differences between the approved and denied groups in all-cause total health care (P = 0.393) or MH-related health care costs (P = 0.054).  CONCLUSIONS: The current study found that GXR coverage denial was associated with lower rate of ADHD medication utilization, greater delay in receiving ADHD medication, and lower PDC with ADHD medication. There were no differences observed between the approved and denied group in terms of all-cause total health care or MH-related total health care costs after controlling for potentially confounding variables. Prior to implementation in the ADHD therapeutic area and others, payers should consider the potentially unintended consequences of ST policies, including delay in treatment and undertreatment.

Relationship of diabetes complications severity to healthcare utilization and costs among Medicare Advantage beneficiaries.

OBJECTIVES: This study evaluated the usefulness of the Diabetes Complications Severity Index (DCSI) in assessing healthcare resource utilization (HRU) and costs among Medicare Advantage plan members diagnosed with type 2 diabetes mellitus (T2DM). STUDY DESIGN: A retrospective cohort study of medical and pharmacy claims of 333,576 Medicare members aged 18 to 89 years with ≥1 medical claim with primary diagnosis or ≥2 medical claims with secondary diagnosis, of T2DM (International Classification of Diseases, Ninth Revision, Clinical Modification code 250.x0 or 250.x2) during the period of January 1, 2010, to December 31, 2011. METHODS: DCSI was assessed concurrently with HRU and healthcare costs (total, medical, and pharmacy). The cohort was subdivided into 6 DCSI groups: DCSI = 0 (no complications) through DCSI = 5+ (≥5). Associations of complication severity with HRU and costs of care were summarized using regression models. RESULTS: A 1-point increase in DCSI was associated with a $2744 increase in total costs (a $2480 increase in medical costs plus a $264 increase in pharmacy costs). Increasing DCSI was associated with greater use of inpatient and emergency department (ED) services. Among the higher complications subgroups, there were greater representations of older patients, men, and cases of depressive disorders and hypoglycemia. CONCLUSIONS: DCSI is useful for identifying Medicare plan members with T2DM who should be targeted for clinical programs. HRU and costs increased with DCSI severity. Increases in high-cost HRU, driven by inpatient and ED visits, suggest that preventing or delaying utilization of these services are essential to driving down costs in the T2DM population. Furthermore, high rates of depression and hypoglycemia warrant early screening and necessary treatment to improve patient outcomes.