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To examine trends in the direct acting antiviral (DAA) uptake in a multi-state Medicaid population with hepatitis C virus (HCV) prior to and after ledipasvir/sofosbuvir (LDV/SOF) approval and changes in prior authorization (PA) requirements.Analyses utilized enrollment, medical, and pharmacy claims in four states, December 2013-December 2017.An interrupted time series examined trends in uptake (1+ claim for a DAA) before and after two events: LDV/SOV approval (October 2014) and lifting of PA requirements for 40% of members (July 2016). Analyses were also performed in subgroups defined by the number and dates of change in PA requirements in members' Medicaid plans.Members aged 18-64 years with an ICD code for HCV were included in the sample from diagnosis date until treatment initiation or Medicaid disenrollment.The annual sample size ranged from 38,302 to 45,005 with approximately 30% ages 18-34 years and 40% female. In December 2013, 0.08% was treated, rising to 0.74% in December 2017 (p 0.001). Uptake increased from 0.34%/month in October 2014 to 0.70%/month after LDV/SOF approval, (p 0.001), and increased relative to the pre-LDV/SOV trend through June 2016 (p = 0.04). Uptake increased to 1.18%/month after PA change, (p 0.001) and remained flat through 2017 (p = 0.64). Cumulatively, 20.1% were treated by December 2017. In plans with few/no requirements through 2017, uptake increased to 1.19%/month after LDV/SOF approval (p 0.001) and remained flat through 2017 (p = 0.11), with 22.2% cumulatively treated. Among plans that lifted PA requirements from three to zero in mid-2016, uptake did not increase after LDV/SOF approval (p = 0.36) but did increase to 1.41%/month (p 0.001) after PA change, with 18.1% cumulatively treated.HCV Treatment increased through 2017. LDV/SOF approval and lifting PA requirements led to an increase in uptake followed by flat monthly utilization. Cumulative uptake was higher in plans with few/no PA requirements relative to those with three requirements through mid-2016.

To evaluate the cost-benefit of sacubitril/valsartan in adults with heart failure (HF) enrolled in a state Medicaid plan to prevent HF-related hospitalizations and emergency department (ED) visits.Retrospective, claims-based, cost-benefit study.This exploratory cost-benefit study evaluated Massachusetts Medicaid (MassHealth) members with HF who had an initial pharmacy claim for sacubitril/valsartan between July 7, 2015, and August 31, 2018 (index date). Efficacy outcomes, HF-related hospitalizations and ED visits, and cost outcomes for HF-related medical and pharmacy claims were compared 1 year pre- and post index date. Benefit-cost ratio and net benefit were calculated for all members. A subgroup analysis evaluated the outcomes for members who were adherent to sacubitril/valsartan.A total of 22 members were identified for the study. There were fewer hospitalizations and ED visits post sacubitril/valsartan initiation in the overall population (post vs pre-: 23 vs 26) and among 12 members adherent to sacubitril/valsartan (10 vs 12). The median (IQR) cost for hospitalizations and ED visits was lower during the postindex period ($576 [$19,439] vs $132 [$11,692]) whereas the median (IQR) cost for HF pharmacotherapies was greater during the postindex period ($4578 [$3033] vs $270 [$255]). The benefit-cost ratio and net benefit were 0.91 and -$336, respectively, for all members and 1.43 and $2337, respectively, for members adherent to sacubitril/valsartan.The benefit as demonstrated by the cost avoidance of HF-related hospitalizations and ED visits did not outweigh the additional costs of sacubitril/valsartan, but cost-benefit was observed in members who were adherent to sacubitril/valsartan.

Postpartum health care among women with intellectual and developmental disabilities has not been well studied. This study uses administrative claims to compare postpartum outpatient visits among women with and without intellectual and developmental disabilities.Massachusetts All Payers Claims Database 2012-2015 was used to identify women with intellectual and developmental disabilities and a live birth during 2012-2014, matched by infant birth year to 3 women without intellectual and developmental disabilities. Women were followed up for 1 year after delivery. Analyses were conducted in 2019. Poisson regression compared guideline-concordant postpartum and other outpatient visits during the early (21-56 days after delivery) and late (57-365 days after delivery) periods. Types of nonpostpartum care visits were examined.Overall, 962 and 2,886 women with and without intellectual and developmental disabilities, respectively, comprised the sample. Among women with intellectual and developmental disabilities, 23.9% had a postpartum visit in the early and 33.3% in the late postpartum periods, compared with 25.2% and 32.1% of women without intellectual and developmental disabilities who had visits in the early and late postpartum periods, respectively (p=0.49, 0.59). Women with intellectual and developmental disabilities were more likely to have other outpatient visits than those without intellectual and developmental disabilities, both in the early (63.1% vs 40.3%, adjusted RR=1.42, 95% CI=1.28, 1.58, p0.001) and late (94.2% vs 82.3%, RR=1.11, 95% CI=1.08, 1.14, p=0.008) postpartum periods. Ancillary services, home health services, and alcohol/drug-related visits were much more common among women with intellectual and developmental disabilities.Women with intellectual and developmental disabilities are equally likely to receive guideline-concordant postpartum visits and more likely to have other outpatient visits than other women. Further research is needed to evaluate visit quality and identify best practices to support mothers with intellectual and developmental disabilities during the postpartum period.

OBJECTIVES To assess the effectiveness of a proactive provider intervention in prompting prior authorization (PA) submissions or provider response prior to PA expiration for medically complex Medicaid patients. STUDY DESIGN Pre-post outreach study with data from pharmacy claims and provider outreach. METHODS The intervention and historical comparison (control) groups included expired PAs from December 2019 to February 2020 and from December 2018 to February 2019, respectively. Provider outreach, including telephonic and fax attempts, was conducted over a 2-week period prior to PA expiration. Outcomes were classified as positive or negative based on provider conversation coupled with the result (eg, PA submission) for the intervention group and based solely on pharmacy claims for the control group. The primary end point was the percentage of positive outcomes between the groups, analyzed via χ2 test. The time from PA expiration to the new PA submission was evaluated via t test. RESULTS A total of 342 outreach attempts were conducted for 270 PAs representing 193 unique patients. Outreach was more likely to result in positive outcomes in the intervention group vs no outreach in the control group (87% vs 25%; P

BackgroundAn emerging body of evidence underscores the often-intensive perinatal healthcare needs of women with intellectual and developmental disabilities (IDD). However, population-based research examining postpartum experiences of US women with IDD is sparse. We examined emergency department (ED) use in the postpartum period among Massachusetts mothers with IDD.MethodsWe analysed 2002–2010 Massachusetts Pregnancy to Early Life Longitudinal data to compare any and ≥2 ED visits between mothers with and without IDD: within 1–42 days post partum, 1–90 days post partum and 1–365 days post partum. We also determined whether or not such ED use was non-urgent or primary-care sensitive.ResultsWe identified 776 births in women with IDD and 595 688 births in women without IDD. Across all three postpartum periods, women with IDD were vastly more likely to have any postpartum ED use, to have ≥2 ED visits and to have ED visits for mental health reasons. These findings persisted after controlling for numerous sociodemographic and clinical characteristics. Women with IDD were less likely to have non-urgent ED visits during the three postpartum periods and they were less likely to have primary-care sensitive ED visits during the postpartum period.ConclusionThese findings contribute to the emerging research on perinatal health and healthcare use among women with IDD. Further research examining potential mechanisms behind the observed ED visit use is warranted. High ED use for mental health reasons among women with IDD suggests that their mental health needs are not being adequately met.

Background Over a third of preadolescent children with overweight or obesity. The American Academy of Pediatrics (AAP) recommends pediatric providers help families make changes in eating and activity to improve body mass index (BMI). However, implementation is challenging given limited time and referral sources, and family burden to access in-person weight management programs. Purpose To describe the design of a National Heart Blood and Lung Institute sponsored cluster randomized controlled pediatric-based trial evaluating the effectiveness of the Fitline pediatric practice-based referral program to reduce BMI and improve diet and physical activity in children with overweight or obesity. Comparison will be made between brief provider intervention plus referral to (1) eight weekly nutritionist-delivered coaching calls with workbook to help families make AAP-recommended lifestyle changes (Fitline-Coaching), vs. (2) the same workbook in eight mailings without coaching (Fitline-Workbook). Methods Twenty practices are pair-matched and randomized to one of the two conditions; 494 parents and their children ages 8–12 with a BMI of ≥85th percentile are being recruited. The primary outcome is child BMI; secondary outcomes are child's diet and physical activity at baseline and 6- and 12-months post-baseline. Cost-effectiveness of the two interventions also will be examined. Conclusion This is the first randomized controlled trial to examine use of a centrally located telephonic coaching service to support families of children with overweight and obesity in making AAP-recommended lifestyle changes. If effective, the Fitline program will provide an innovative model for widespread dissemination, setting new standards for weight management care in pediatric practice. Trial registration: The ClinicalTrials.gov registration number is NCT03143660 .

In response to concerns surrounding pediatric behavioral health medication prescribing, the Massachusetts Medicaid Pharmacy Program implemented a Pediatric Behavioral Health Medication Initiative (PBHMI), proactively requiring prior authorization for specific behavioral health medications and combination regimens. A multidisciplinary therapeutic class management (TCM) workgroup retrospectively reviews complex cases and conducts prescriber outreach to encourage evidence-based practices in Massachusetts.To evaluate recommendation outcomes of telephonic peer-to-peer consultations conducted by the PBHMI TCM workgroup by assessing the percentage of accepted, modified accepted, or rejected recommendations, as well as prescriber satisfaction with consultation.This retrospective evaluation reviewed PBHMI TCM workgroup cases with completed peer-to-peer consultations from September 1, 2015, to August 28, 2016. The proportion of medication interventions (e.g., medication changes, dose reductions, and elimination of polypharmacy within or across behavioral health medication classes) accepted, modified accepted, or rejected were assessed based on pharmacy claims data and prior authorization resubmission, following a peer-to-peer consultation. The medication class and prescriber type were categorized in relation to the acceptance, modified acceptance, or rejection outcomes. Satisfaction with the TCM workgroup process was evaluated with an anonymous survey offered to prescribers who participated in prescriber outreach.A total of 70 cases requiring a peer-to-peer consultation by a TCM workgroup child/adolescent psychiatrist had a completed outreach attempt during the evaluation period. Peer-to-peer consultations resulted in a recommendation acceptance rate of 31.4% (22/70), modified acceptance rate of 44.3% (31/70), and a rejection rate of 24.3% (17/70). Recommendations made during a peer-to-peer consultation were rejected by 30% (12/40) of child/adolescent psychiatrists compared with 16.7% (5/30) of nonchild/adolescent psychiatrists with completed peer-to-peer consultations (P = 0.43). Antipsychotics were most frequently recommended for regimen changes. All recommendations pertaining to a benzodiazepine were accepted by the prescriber. Results of an anonymous prescriber survey assessing satisfaction with the peer-to-peer consultation process exhibited variable responses among individual prescribers.The small sample size in this observational evaluation and lack of a defined control group prevented direct associations between the endpoints and outcomes. Further research is required to determine if prescriber specialty and medication class may be influencing factors on recommendation acceptance.No outside funding supported this study. The authors have nothing to disclose. A poster of this project was presented at the AMCP Managed CareSpecialty Pharmacy Annual Meeting 2017; March 27-30, 2017; in Denver, CO.

Background Poor medication adherence has been shown to cause medical complications, death, and increased healthcare costs and may be of particular importance in patients with substance use disorder (SUD). Concerns regarding adherence in this population may influence a healthcare provider’s decision to prescribe a medication requiring high adherence. Guidance defining best practices that promote adherence among individuals with SUD is lacking. Methods A review of English articles in Medline and PsycINFO databases, published between October 1, 1994 and October 31, 2017, was conducted in order to identify studies of interventions intended to improve adherence to oral chronic disease medication regimens among patients with SUD. Randomized controlled trials, quasi-experimental study designs, and case series were included. Article quality was assessed. Results A total of 854 abstracts were retrieved, of which 24 met inclusion criteria. Adherence interventions were categorized as those: 1) addressing the chronic disease state; 2) addressing SUD; or 3) both. Studies varied greatly with respect to intervention length, method of measuring adherence, and quality. Statistically significant improvement in adherence was observed in 12 of 24 studies (50%). Specific interventions that improved adherence included incentive-based interventions, directly observed therapy, and telephonic/home visits. Counseling-based interventions such motivational interviewing and cognitive behavioral therapy presented mixed results. Conclusions While effective interventions were identified, heterogeneity of study designs and study quality preclude determination of optimal interventions to promote adherence in this population. Further evaluation with sound study design may inform the development of best practices for treating chronic disease in patients with SUD.

Background Women with disabilities are at risk for poor birth outcomes. Little is known about specific potentially disabling health conditions and their effects on pregnancies. Using hospital claims, we identified women at risk for disability and evaluated the relationship between disability risk and demographic characteristics, pregnancy risks, and infant and maternal outcomes. Methods The 2006 through 2009 Massachusetts Pregnancy to Early Life Longitudinal data system linked birth certificate and hospital claims one year pre-pregnancy through delivery. Access Risk Classification System categorized International Classification of Diseases, Ninth Revision, Clinical Modification /Current Procedural Terminology codes into disability risk groups (no/limited vs. medium/high). Generalized estimating equations evaluated the association between disability risk and infant and maternal outcomes. Results Of 221,867 women, 14,701 (6.6%) were at medium or high risk of disability. Health conditions were classified as circulatory (23%), musculoskeletal (10%), nervous system/sensory (13%), other physical (19%), two or more physical (5%), mental illness (24%), and comorbid mental/physical (6%). Women at risk of disability were more likely than others to have socioeconomic and pregnancy risks, and adverse infant and maternal outcomes. Socioeconomic and risk profile varied by health condition category. Adjusted risk ratios for preterm birth ranged from 1.2 (95% confidence interval [CI], 1.1–1.4) for women with nervous system/sensory diagnoses to 1.6 (95% CI, 1.4–1.9) for women with two or more physical diagnoses; risk ratios for maternal delivery hospitalization for more than 5 days ranged from 1.5 (95% CI, 1.2–1.9) for women with musculoskeletal diagnoses to 3.0 (95% CI, 2.5–3.6) for women with comorbid mental/physical diagnoses. Conclusions Disability risk identified through claims is associated with poor infant and maternal outcomes. Risk profiles vary by underlying health condition.

BACKGROUND: Women with disabilities are at risk for poor birth outcomes. Little is known about longer-term health and healthcare utilization of infants of women with disabilities. OBJECTIVES: We identified women at risk for disability and evaluated their infants’ emergency department (ED) utilization during the first year of life. STUDY DESIGN: This population-based cohort study used Massachusetts 2007–2009 birth certificates linked to 2007–2010 hospital discharge data. Access Risk Classification System categorized ICD-9 CM/CPT codes into disability risk categories. Infant ED visits were evaluated overall and by severity (emergent/intermediate vs. non-emergent). Cox proportional hazards models provided adjusted estimates. Results were stratified by gestational age (preterm, < 37 weeks, term, 37+ weeks). RESULTS: Of 218,599 women, 6.7% were at risk of disability. Infants born to women at risk had a higher rate of ED visits in their first year than infants born to women not at risk: 0.85 visits/person-year (95% CI 0.84–0.87) vs. 0.55 (0.55–0.55) for term, 0.74 (0.70–0.77) vs. 0.55 (0.54–0.56) for preterm. Utilization varied by maternal diagnosis. Emergent/intermediate and non-emergent visits were both elevated among infants born to women at risk for disability. In adjusted analyses, term infants of women with musculoskeletal diagnoses (HR=1.3, 95% CI 1.2–1.4) and preterm infants of women with circulatory diagnoses (HR=1.2, 1.0–1.3) had the highest hazards of ED visit vs. infants of women not at risk of disability. CONCLUSION: Maternal disability risk is associated with postnatal infant ED utilization; utilization varies by maternal diagnosis. Interventions to improve health of infants born to women with disabilities are warranted.

Policies that address opioid dose limits may help to decrease high-risk opioid prescribing. We evaluated 3 sequential and progressive decreases in high-dose (HD) opioid limits implemented by Massachusetts Medicaid over 15 years. The study population included members ages 18 to 64 years with ≥1 claim for a schedule II opioid between January 2002 and March 2017. The 3 interventions consisted of prior authorization requirements for prescriptions exceeding the morphine equivalent dose (MED) HD dose limits:360 mg (intervention 1a and 1b),240 mg (intervention 2), and120 mg (intervention 3). A segmented regression evaluated the change in natural log of the average daily MED (AD_MED). The natural log of the AD_MED decreased during the 6 quarters after intervention 1a (P.001), immediately after intervention 1b (P = .0002), and continued to decrease over the following 8 quarters (P = .023). The natural log of the AD_MED decreased immediately after intervention 2 (P = .002) and again after intervention 3 (P.001). The percentage of users exceeding the HD limits of 360 mg, 240 mg, and 120 mg MED decreased by 87.3%, 79.8%, and 75.2% from baseline, respectively. The natural log of the AD_MED decreased among members after implementation of 3 sequential and progressive HD prior authorization limits, as did the percentage of members exceeding each of the HD limits. PERSPECTIVE: This study demonstrates the longitudinal impact of a prior authorization policy-based HD limit in a Medicaid population. This study contributes to options for policymakers and other Medicaid programs as a potential strategy to assist in addressing the opioid epidemic.

The primary goal of therapy for patients with chronic hepatitis C virus (HCV) infection is eradication of HCV ribonucleic acid, which is predicted by achievement of sustained virologic response at 12 weeks (SVR12). Ledipasvir/sofosbuvir was approved by the FDA in 2014 and 2015 as a once-daily regimen for the treatment of HCV genotype 1 and HCV genotypes 4, 5, and 6, respectively. Although its efficacy has been demonstrated in randomized controlled trials, there is an unmet need for real-world effectiveness data and studies that assess the association of rates of SVR12 with specific clinical and demographic factors in the Medicaid population.To (a) evaluate the effectiveness of HCV genotype 1 treatment with ledipasvir/sofosbuvir as measured by the rate of SVR12 overall and within the subgroups of 8-, 12-, and 24-week regimens and (b) identify predictors of treatment failure in the Massachusetts Medicaid (MassHealth) population.This retrospective cohort study evaluated the rate of SVR12 among 796 MassHealth Primary Care Clinician and fee-for-service plan members who completed treatment with at least one 8-, 12-, or 24-week treatment with ledipasvir/sofosbuvir for HCV genotype 1 infection between October 10, 2014, and November 1, 2016. The following variables were evaluated to identify predictors of treatment failure: sex, history of treatment failure, cirrhosis, substance use disorder, human immunodeficiency virus coinfection, and concomitant use of interacting medications. The proportion of members who achieved SVR12 was calculated for the entire study population and stratified by treatment regimen. Chi-square tests were used to compare the proportion of members who achieved SVR12, stratified by clinical and demographic variables.SVR12 was achieved in 95% (756/796) of members. High proportions of members who received 8 weeks of treatment or 12 weeks of treatment without concomitant ribavirin achieved SVR12 (96.0% [285/297] and 95.7% [382/399], respectively). A slightly lower proportion of members who received 12 weeks of treatment with concomitant ribavirin or 24 weeks of treatment achieved SVR12 (89.9% [62/69] and 87.1% [27/31], respectively). The proportion of members who achieved SVR12 with each treatment regimen was consistent when stratified by clinical and demographic variables. None of the included variables were found to be associated with statistically significant differences in odds of treatment failure.In the Medicaid population of 1 state, treatment of HCV genotype 1 infection with ledipasvir/sofosbuvir was associated with a high rate of SVR12. The outcomes of treatment of HCV genotype 1 infection with ledipasvir/sofosbuvir in the Medicaid population are comparable with outcomes observed in other patient populations.No outside funding supported this study. The authors have no financial disclosures. A poster of this manuscript was presented at the Academy of Managed Care Pharmacy 2017 Annual Meeting, March 27-30, 2017, in Denver, Colorado.

Background: Little is known about the effect of potentially disabling health conditions on healthcare utilization during pregnancy. Using hospital discharge data, we identified women at risk for disability and evaluated antenatal hospital utilization, including emergency department (ED), observational stay (OS), and inpatient (IP) visits, by underlying health condition. Materials and Methods: Massachusetts Pregnancy to Early Life Longitudinal data system linked 2007–2009 birth certificates to 2006–2009 discharges. Access Risk Classification System categorized ICD-9-CM/Current Procedural Terminology codes recorded at delivery into disability risk groups (no/low vs. medium/high). Women were further categorized based on delivery diagnoses. Cox models evaluated the association between disability risk and utilization. Utilization by prenatal care and visit reason was examined. Results: Of 221,867 women, 4.0% were at medium/high risk of disability. Mental illness (26.9%) and circulatory system (25.2%) diagnoses were most common. More than 2% had comorbid mental/physical conditions. Women at risk for disability were more likely than women not at risk to have an antenatal ED (37.1% vs. 25.0%), OS (19.1% vs. 13.1%), or nondelivery IP visit (11.5% vs. 4.0%) (p ≤ 0.001 for each). Utilization varied by diagnosis. In adjusted analyses, women with two or more physical conditions had highest rate of ED visit (hazard ratio [HR] = 2.3, 95% confidence interval 1.8–2.8) and OS/IP visit (HR = 2.9, 95% 2.3–3.6) compared with women not at risk. Inadequate prenatal care was associated with increased utilization across all disability risk groups. ED visits for mental illness were high across groups. Conclusions: Disability risk identified in discharge data is associated with elevated antenatal hospital utilization. Utilization varies by underlying diagnosis.

Objectives The objective of this study is to describe the maternal characteristics, pregnancy complications, and birth outcomes among a representative sample of Rhode Island women with disabilities who recently gave birth. Methods Data from the 2002-2011 Rhode Island Pregnancy Risk Assessment Monitoring System survey were analyzed. Results Approximately 7% of women in Rhode Island reported a disability. Women with disabilities reported significant disparities in their health care utilization, health behaviors, and health status before and during pregnancy and during the postpartum period. Compared with nondisabled women, they were significantly more likely to report stressful life events and medical complications during their most recent pregnancy, were less likely to receive prenatal care in the first trimester, and more likely to have preterm births (13.4%; 95% CI, 11.6-15.6 compared with 8.9%; 95% CI, 8.5-9.3 for women without disabilities) and low-birth-weight babies (10.3%; 95% CI, 9.4-11.2 compared with 6.8%; 95% CI, 6.8-6.9). There was no difference in the rates of cesarean section between women with and without disabilities. Conclusions These findings support the need for clinicians providing care to pregnant women with disabilities to be aware of the increased risk for medical problems during pregnancy and factors that increase the risk for poor infant outcomes.

Objective The objective of this study was to compare the prevalence of select preconception health indicators among women with and without disabilities. Methods 2010 Behavioral Risk Factor Surveillance System data were used to estimate the prevalence of health behaviors, health status indicators, and preventive health care among non-pregnant women ages 18–44 years with (N = 8370) and without (N = 48,036) disabilities. Crude percentages were compared with Chi square statistics. Multivariable logistic regressions adjusted for socio-demographic factors. Results Women with disabilities were more likely than women without disabilities to currently smoke (30.5 vs. 14.5 %, p

In 2012, hydrocodone combination products (HCPs) were the most prescribed medications in the United States. Under the Controlled Substance Act of 1970, hydrocodone alone was classified as a Schedule II drug, while HCPs were classified as Schedule III, indicating a lower risk for abuse and misuse. However, according to a Drug Enforcement Agency analysis, the addition of nonopioids has not been shown to diminish abuse potential of hydrocodone. In response to concerns for drug abuse and overdose, the Drug Enforcement Agency rescheduled HCPs to Schedule II in October 2014, with the intent of limiting overprescribing and increasing awareness of their abuse potential. However, it is unknown whether this has affected the overall claims for HCPs in a Medicaid population.To (a) compare the trend in HCP prescription claims with select non-HCP (opioid and nonopioid) analgesic claims before and after the HCP schedule change in the Massachusetts Medicaid fee-for-service/Primary Care Clinician plan population and (b) identify if there was a change in HCP new start member and claim characteristics before and after the HCP schedule change.This quasi-experimental, retrospective study used enrollment and pharmacy claims data to evaluate all members in the study population 1 year before and after the HCP schedule change. The number of claims for HCPs and select non-HCP analgesics was reported as the monthly rate per total population, and an interrupted time series analysis compared the change in the monthly rate of claims across groups. Members with 1 or more pharmacy claims for a new HCP prescription during a 5-month period before or after the HCP schedule change were analyzed to determine member demographics (age, gender, and number of claims) and claim characteristics (average daily dose, average quantity per claim, and days supply).The rate of HCP claims increased before and decreased after the HCP schedule change. Controlling for the trend during the period before the HCP schedule change, the rate of HCP claims per 1,000 members per month decreased at a greater rate than non-HCP analgesics in the period after the HCP schedule change (P0.001). The percentage of HCP claims for new start members decreased after the HCP schedule change (44.9% vs. 34.1% of all HCP claims pre- to post-schedule change; P0.001). In the group of new starts, there was not a significant difference in the average daily dose (26.3 mg vs. 26.4 mg; P = 0.69), while there was a decrease in average number of tablets dispensed per claim (from 37.1 to 20.3 tablets; P0.001) and an increase in the percentage of claims for a shorter days supply (from 57.7% to 81.6%; P0.001).The findings of this study suggest that the HCP schedule change may have contributed to the decrease in claims for HCPs in a Medicaid population. After the HCP schedule change, there was a trend towards decreased HCP use among new starts.No outside funding supported this study. The authors have nothing to disclose. Study concept and design were contributed by all authors except for Arnold and Clements. Tran, Arnold, and Clements took the lead in data collection, along with Peristere, and data interpretation was performed by all the authors, except Arnold. The manuscript was written primarily by Tran, along with Lavitas, Stevens, and Greenwood, and revised by all the authors except Arnold and Peristere. A poster of this research project was presented at the Academy of Managed Care Pharmacy's 2016 Annual Meeting in San Francisco, California, April 2016.

OBJECTIVE: We examined trends in autism spectrum disorder diagnoses by age 36 months (early diagnoses) and identified characteristics associated with early diagnoses. METHODS: Massachusetts birth certificate and early-intervention program data were linked to identify infants born between 2001 and 2005 who were enrolled in early intervention and receiving autism-related services before age 36 months (through December 31, 2008). Trends in early autism spectrum disorders were examined using Cochran-Armitage trend tests. χ2 Statistics were used to compare distributions of selected characteristics for children with and without autism spectrum disorders. Multivariate logistic regression analyses were conducted to identify independent predictors of early diagnoses. RESULTS: A total of 3013 children (77.5 per 10 000 study population births) were enrolled in early intervention for autism spectrum disorder by age 36 months. Autism spectrum disorder incidence increased from 56 per 10 000 infants among the 2001 birth cohort to 93 per 10 000 infants in 2005. Infants of mothers younger than 24 years of age, whose primary language was not English or who were foreign-born had lower odds of an early autism spectrum disorder diagnosis. Maternal age older than 30 years was associated with increased odds of an early autism spectrum disorder diagnosis. Odds of early autism spectrum disorders were 4.5 (95% confidence interval: 4.1–5.0) times higher for boys than girls. CONCLUSIONS: Early autism spectrum disorder diagnoses are increasing in Massachusetts, reflecting the national trend observed among older children. Linkage of early-intervention program data with population-based vital statistics is valuable for monitoring autism spectrum disorder trends and planning developmental and educational service needs.

Objectives To evaluate whether Massachusetts Early Intervention (EI) serves children at risk of developmental delay due to social factors, we identified socio-demographic characteristics associated with program enrollment and examined predictors of participation at each stage from referral to enrollment. Methods The Pregnancy to Early Life Longitudinal (PELL) data system linked birth certificate, hospital discharge, and EI data for all Massachusetts births, 1998–2000. We identified predictors of enrollment among births and predictors of referral, eligibility evaluation among those referred, and enrollment among eligible children using multivariate modified Poisson models to adjust for medical risks. Results Overall, 29,950 children (13.7% of births) enrolled in EI. Most social risk indicators predicted enrollment, including maternal government insurance (RR = 1.32, 95% CI 1.29–1.36) and maternal education ≤10 years (RR = 1.36, 95% CI 1.30–1.42). Having a foreign-born (RR = 0.77, 95% CI 0.74–0.80), non-English speaking (RR = 0.93, 95% CI 0.89–0.97) or Asian (RR = 0.88, 95% CI 0.82–0.94) mother was negatively associated with enrollment. Of births, 18.6% were referred to EI. Similar socio-demographic variables predicted referral as predicted enrollment. Among referrals, 87.7% received an evaluation. Evaluation was negatively associated with young maternal age, black maternal race, and high poverty level. Of eligible children, 93.0% enrolled. Enrollment among eligible children was negatively associated with young maternal age and high poverty level. Conclusion In Massachusetts, children born with social risk factors have high EI participation. Nevertheless, children in immigrant communities may face barriers to initial contact with EI, while children from low socioeconomic environments may be at risk for not enrolling after EI referral.

OBJECTIVES. Characterizing the cost of preterm birth is important in assessing the impact of increasing prematurity rates and evaluating the cost-effectiveness of therapies to prevent preterm delivery. To assess early intervention costs that are associated with preterm births, we estimated the program cost of early intervention services for children who were born in Massachusetts, by gestational age at birth. METHODS. Using the Pregnancy to Early Life Longitudinal Data Set, birth certificates for infants who were born in Massachusetts between July 1999 and June 2000 were linked to early intervention claims through 2003. We determined total program costs, in 2003 dollars, of early intervention and mean cost per surviving infant by gestational age. Costs by plurality, eligibility criteria, provider discipline, and annual costs for children's first 3 years also were examined. RESULTS. Overall, 14033 of 76901 surviving infants received early intervention services. Program costs totaled almost $66 million, with mean cost per surviving infant of $857. Mean cost per infant was highest for children who were 24 to 31 weeks' gestational age ($5393) and higher for infants who were 32 to 36 weeks' gestational age ($1578) compared with those who were born at term ($725). Cost per surviving infant generally decreased with increasing gestational age. Among children in early intervention, mean cost per child was higher for preterm infants than for term infants. At each gestational age, mean cost per surviving infant was higher for multiples than for singletons, and annual early intervention costs were higher for toddlers than for infants. CONCLUSIONS. Compared with their term counterparts, preterm infants incurred higher early intervention costs. This information along with data on birth trends will inform budget forecasting for early intervention programs. Costs that are associated with early childhood developmental services must be included when considering the long-term costs of prematurity.

Purpose Monthly dosing with ranibizumab (RBZ) is needed to achieve maximal visual gains in patients with neovascular (‘wet’) age-related macular degeneration (wAMD). In Sweden, dosing is performed as needed (RBZ PRN), resulting in suboptimal efficacy. Intravitreal aflibercept (IVT-AFL) every 2 months after three initial monthly doses was clinically equivalent to RBZ monthly dosing (RBZ q4) in wAMD clinical trials. We assessed the cost-effectiveness of IVT-AFL versus RBZ q4 and RBZ PRN in Sweden. Methods A Markov model compared IVT-AFL to RBZ q4 or RBZ PRN over 2 years. Health states were based on visual acuity in better-seeing eye; a proportion discontinued treatment monthly or upon visual acuity

Objective To validate information on private health insurance coverage in a population-based study. Methods Respondents to the Massachusetts Behavioral Risk Factor Surveillance System were asked the name of their health plan company (affiliation) and specific brand of insurance (product), the duration in which they belonged to the plan, and demographic and health-related data. Information on plan affiliation and product was used to classify individuals on type of coverage. At the end of the survey, respondents with health insurance were asked to retrieve their health plan cards, and to read detailed information from the cards. Self-reported data were compared with information from the cards. Results Self-reported information on health plan affiliation agreed with plan cards for 93 percent of individuals, while agreement was 79 percent for health plan product. Among health maintenance organization (HMO) participants, 93 percent correctly reported being in an HMO (sensitivity), whereas 76 percent of respondents in a non-HMO plan correctly self-reported (specificity). Individuals with higher levels of income, those with a primary care doctor, and those in a health plan for at least 1 year had higher agreement. Higher validity was associated with poor physical health and recent cancer screening. Conclusions Self-reported data on health plan affiliation and product have good validity in a population-based sample of adults. While agreement differs according to specific respondent characteristics, these differences do not appear substantial.

In October 2011, clobazam was FDA-approved for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS), a debilitating childhood epilepsy characterized by drop attacks, for patients 2 years and older.To assess the budget impact of adding clobazam to an antiepileptic drug (AED) portfolio containing topiramate, lamotrigine, and rufinamide in a hypothetical, 100,000-member commercially insured health plan.Patient characteristics and AED efficacy (decrease in drop-seizure frequency) were modeled with clinical data. Medical costs were derived from administrative claims data from a large U.S. managed health plan, with the assumption that 2.3% of drop seizures required medical care. Two-year budget impact was measured. Results were expressed as the overall difference in costs (medical and pharmacy) to a health plan and cost per member per month (PMPM) after addition of clobazam. Analyses of alternative scenarios were performed.With the assumption that 0.04% of the plan population had LGS, adding clobazam to the formulary resulted in cost savings of $98,059 in year 1 and $131,690 in year 2 (savings of $0.08 and $0.11 PMPM, respectively). Analyses of alternative scenarios with lower seizure rates upon discontinuation or greater long-term efficacy for lamotrigine and topiramate did not substantially alter conclusions. The assumption that fewer drop seizures required medical care resulted in a savings of approximately $5,000 per year with clobazam, which suggested that medically attended drop seizures drive costs.Medically attended drop seizures are a major cost driver for LGS patients. Adding clobazam to a health plan formulary can have a positive overall budget impact through decreased medical costs associated with drop seizures.

There is currently no population-based research on the maternal characteristics or birth outcomes of U.S. women with intellectual and developmental disabilities (IDDs). Findings from small-sample studies among non-U.S. women indicate that women with IDDs and their infants are at higher risk of adverse health outcomes.To describe the maternal characteristics and outcomes among deliveries to women with IDDs and compare them to women with diabetes and the general obstetric population.Data from the 1998-2010 Massachusetts Pregnancy to Early Life Longitudinal database were analyzed between November 2013 and May 2014 to identify in-state deliveries to Massachusetts women with IDDs.Of the 916,032 deliveries in Massachusetts between 1998 and 2009, 703 (0.1%) were to women with IDDs. Deliveries to women with IDDs were to those who were younger, less educated, more likely to be black and Hispanic, and less likely to be married. They were less likely to identify the father on the infant's birth certificate, more likely to smoke during pregnancy, and less likely to receive prenatal care during the first trimester compared to deliveries to women in the control groups (p0.01). Deliveries to women with IDDs were associated with an increased risk of adverse outcomes, including preterm delivery, very low and low birth weight babies, and low Apgar scores.Women with IDDs are at a heightened risk for adverse pregnancy outcomes. These findings highlight the need for a systematic investigation of the pregnancy-related risks, complications, costs, and outcomes of women with IDDs.

Background . Pharmacological treatment of depression in geriatric patients is often difficult. Although unsupervised exercise has been shown to benefit younger depressed patients, there is no evidence that unsupervised exercise can be used as a maintenance treatment for depression in elderly patients. Our aim was to test the feasibility and efficacy of un- supervised exercise as a long-term treatment for clinical depression in elderly patients. Methods. We studied 32 subjects (71.3 � 1.2 years of age, meanSE ) in a 20-week, randomized, controlled trial, with follow-up at 26 months. Subjects were community-dwelling patients with major or minor depression or dysthymia. Exercisers engaged in 10 weeks of supervised weight-lifting exercise followed by 10 weeks of unsupervised exercise. Controls attended lectures for 10 weeks. No contact was made with either group after 20 weeks until final follow-up. Blinded assessment was made with the Beck Depression Inventory (BDI), the Philadelphia Geriatric Morale Scale, and Ewart's Self Efficacy Scale at 20 weeks and with the BDI and physical activity questionnaire at 26 months. Results. Patients randomized to the exercise condition completed 18 � 2 sessions of unsupervised exercise during Weeks 10 to 20. The BDI was significantly reduced at both 20 weeks and 26 months of follow-up in exercisers com- pared with controls ( p � .05-.001). At the 26-month follow-up, 33% of the exercisers were still regularly weight lifting, versus 0% of controls ( p � .05). Conclusions. Unsupervised weight-lifting exercise maintains its antidepressant effectiveness at 20 weeks in de- pressed elderly patients. Long-term changes in exercise behavior are possible in some patients even without supervision.

Although disuse of skeletal muscle and undernutrition are often cited as potentially reversible causes of frailty in elderly people, the efficacy of interventions targeted specifically at these deficits has not been carefully studied.We conducted a randomized, placebo-controlled trial comparing progressive resistance exercise training, multinutrient supplementation, both interventions, and neither in 100 frail nursing home residents over a 10-week period.The mean (+/- SE) age of the 63 women and 37 men enrolled in the study was 87.1 +/- 0.6 years (range, 72 to 98); 94 percent of the subjects completed the study. Muscle strength increased by 113 +/- 8 percent in the subjects who underwent exercise training, as compared with 3 +/- 9 percent in the nonexercising subjects (P0.001). Gait velocity increased by 11.8 +/- 3.8 percent in the exercisers but declined by 1.0 +/- 3.8 percent in the nonexercisers (P = 0.02). Stair-climbing power also improved in the exercisers as compared with the nonexercisers (by 28.4 +/- 6.6 percent vs. 3.6 +/- 6.7 percent, P = 0.01), as did the level of spontaneous physical activity. Cross-sectional thigh-muscle area increased by 2.7 +/- 1.8 percent in the exercisers but declined by 1.8 +/- 2.0 percent in the nonexercisers (P = 0.11). The nutritional supplement had no effect on any primary outcome measure. Total energy intake was significantly increased only in the exercising subjects who also received nutritional supplementation.High-intensity resistance exercise training is a feasible and effective means of counteracting muscle weakness and physical frailty in very elderly people. In contrast, multi-nutrient supplementation without concomitant exercise does not reduce muscle weakness or physical frailty.

Access to Early Intervention (EI) services may improve cognitive and behavioral outcomes in very low birth weight infants, but few states have population-based data to evaluate EI outreach efforts. We analyzed Massachusetts (MA) infants born weighing

Objectives: The Individual with Disabilities Education Act mandates Early Intervention (EI) services for infants and toddlers with developmental delay. We assessed the percentage of infants at risk for developmental delay due to characteristics present at birth who were referred to Massachusetts EI within 1 year of birth, evaluated for eligibility, and eligible for services. In addition, we identified birth characteristics that independently predicted 0–1 year program referral, evaluation, and eligibility. Methods: The Pregnancy to Early Life Longitudinal (PELL) data system linked birth certificate, hospital discharge, and EI program data of 219,037 infants born in Massachusetts, 1998–2000. Multivariate logistic regressions identified independent infant predictors of referral, evaluation, and eligibility. Results: Of 219,037 births, 14,852 (6.8%) were referred to EI within 1 year. Birthweight

BackgroundThe authors sought to monitor the impact of widespread varicella vaccination on the epidemiology of varicella and herpes zoster. While varicella incidence would be expected to decrease, mathematical models predict an initial increase in herpes zoster incidence if re-exposure to varicella protects against reactivation of the varicella zoster virus.MethodsIn 1998–2003, as varicella vaccine uptake increased, incidence of varicella and herpes zoster in Massachusetts was monitored using the random-digit-dial Behavioral Risk Factor Surveillance System.ResultsBetween 1998 and 2003, varicella incidence declined from 16.5/1,000 to 3.5/1,000 (79%) overall with ≥66% decreases for all age groups except adults (27% decrease). Age-standardized estimates of overall herpes zoster occurrence increased from 2.77/1,000 to 5.25/1,000 (90%) in the period 1999–2003, and the trend in both crude and adjusted rates was highly significant (p < 0.001). Annual age-specific rates were somewhat unstable, but all increased, and the trend was significant for the 25–44 year and 65+ year age groups.ConclusionAs varicella vaccine coverage in children increased, the incidence of varicella decreased and the occurrence of herpes zoster increased. If the observed increase in herpes zoster incidence is real, widespread vaccination of children is only one of several possible explanations. Further studies are needed to understand secular trends in herpes zoster before and after use of varicella vaccine in the United States and other countries.

A narrow range of food choices may lead to dietary inadequacies, a particular concern in elderly people. We hypothesized that consumption of a more diverse diet would predict better nutritional status in frail elderly persons.Subjects included 98 frail nursing home residents (36 men, 62 women), mean age 87.1+/-5.5 (72 to 98) years.3-day dietary variety scores ranging from 23 to 48 and fruit and vegetable variety scores ranging from 5 to 20 were calculated from weighed 3-day food records as the number of different food or fruit and vegetable choices consumed. A higher score indicates a more varied diet. Nutritional status was assessed by weight, height, body mass index (BMI), skinfold thickness, circumference measures, calculated mean arm muscle area, total body water, computerized tomography of the thigh, and total body potassium, as well as nutritional analysis, biochemical measures, and subject medical history.Univariate regression analyses were performed to investigate the relationship between clinical and nutrition variables. Multiple linear regressions were used to develop models relating dietary variety scores to possible etiologic factors as well as indicators of nutritional status. Models were controlled for age, BMI, and energy intake when appropriate.Mean dietary variety score was 35.2+/-4.5, and mean fruit and vegetable variety score was 11.3+/-3.0. Higher dietary variety score was associated with higher energy intake (beta = 20.5, P.001) and both high dietary variety score and fruit and vegetable variety score were positively associated with intake for many nutrients (Por = .05). High dietary variety score was related to high fruit and vegetable variety score and total intake of fruits and vegetables. In men, higher dietary variety score and fruit and vegetable variety score were associated with higher high-density lipoprotein (beta = 1.02), lower very-low-density lipoprotein (beta = -3.58) and triglycerol (beta = -3.51), and higher blood folate (beta = 4.72) concentrations in women (Por = .05). In women, high dietary variety score was associated with higher BMI (beta = 0.34, P.001) and higher total body potassium (beta = 1.30, P = .02); high fruit and vegetable variety score was associated with higher BMI (beta = 0.41), mid-arm circumference (beta = 0.34), and mid-arm muscle area (beta = 2.94) (Por = .03). Dietary variety score was higher (mean 37.6+/-5.38 vs 34.6+/-4.14) in those who received assistance with feeding (beta = 2 .67, P = .01). History of cancer (beta = -2.04) and gastrointenstinal cancer (beta = -3.54) were associated with low dietary variety score (Por = .05).The results of this study suggest that a highly varied diet in elderly nursing home residents is associated with better nutritional status as assessed by nutrient intake, biochemical measures, and body composition measures. Dietary variety score is a straightforward tool for screening and identifying people at nutritional risk, as well as a mechanism for monitoring response to nutritional, medical, and environmental interventions. Preventive measures to improve dietary variety, as measured by the dietary variety score, should be evaluated and introduced before nutrition and health complications arise.

To assess muscle remodeling and functional adaptation to exercise and diet interventions, 26 men and women aged 72–98 yr underwent a vastus lateralis biopsy before and after placebo control condition, and progressive resistance training, multinutrient supplementation, or both. Type II atrophy, Z band, and myofibril damage were present at baseline. Combined weight lifting and nutritional supplementation increased strength by 257 ± 62% ( P = 0.0001) and type II fiber area by 10.1 ± 9.0% ( P = 0.033), with a similar trend for type I fiber area (+12.8 ± 22.2%). Exercise was associated with a 2.5-fold increase in neonatal myosin staining ( P = 0.0009) and an increase of 491 ± 137% ( P < 0.0001) in IGF-I staining. Ultrastructural damage increased by 141 ± 59% after exercise training ( P = 0.034). Strength increases were largest in those with the greatest increases in myosin, IGF-I, damage, and caloric intake during the trial. Age-related sarcopenia appears largely confined to type II muscle fibers. Frail elders respond robustly to resistance training with musculoskeletal remodeling, and significant increases in muscle area are possible with resistance training in combination with adequate energy intakes.

We tested the hypothesis that exercise would improve subjective sleep quality and activity in depressed elders. A 10-week randomized controlled trial was utilized. Participants consisted of a volunteer sample, aged > 60 with a diagnosis of major or minor depression or dysthymia. A total of 32 subjects aged 60-84 years with a mean age of 71.3 +/- 1.2 years was used. Intervention consisted of a supervised weight-training program three times a week or an attention-control group. Main outcome measures were Pittsburgh Subjective Sleep Quality Index (PSQI), Likert Scale of Subjective Sleep Quality and Quantity. Paffenbarger Activity Index. Geriatric Depression Scale (GDS). Beck Depression Inventory (BDI), Hamilton Rating Scale of Depression (HRSD), and the Medical Outcomes Survey Short Form 36 (SF-36). Results showed that exercise significantly improved all subjective sleep-quality and depression measures. Depression measures were reduced by approximately twice that of controls. Habitual activity was not significantly increased by exercise. Quality of life subscales significantly improved. In a forward stepwise multiple regression, percent improvement in GDS and percent increase in strength remained significant predictors of the improvement in total PSQI score (r = 0.71, p = 0.0002). In conclusion, weight lifting exercise was effective in improving subjective sleep quality, depression, strength, and quality of life without significantly changing habitual activity.

Background: Depression in elderly people may be contributed to by the multiple losses of aging. Exercise has the potential to positively impact many of these losses simultaneously. We tested the hypothesis that progressive resistance training (PRT) would reduce depression while improving physiologic capacity, quality of life, morale, function and self-efficacy without adverse events in an older, significantly depressed population. Methods: We conducted a 10-week randomized controlled trial of volunteers aged 60 and above with major or minor depression or dysthymia. Subjects were randomized for 10 weeks to either a supervised PRT program three times a week or an attention-control group. Results: A total of 32 subjects aged 60-84, mean age 71.3 +/- 1.2 yr, were randomized and completed the study. No significant adverse events occurred. Median compliance was 95%. PRT significantly reduced all depression measures (Beck Depression Inventory in exercisers 21.3 +/- 1.8 to 9.8 +/- 2.4 versus controls 18.4 +/- 1.7 to 13.8 +/- 2, p = .002; Hamilton Rating Scale of Depression in exercisers 12.3 +/- 0.9 to 5.3 +/- 1.3 versus controls 11.4 +/- 1.0 to 8.9 +/- 1.3, p = .008). Quality of life subscales of bodily pain (p = .001), vitality (p = .002), social functioning (p = .008), and role emotional (p = .02) were all significantly improved by exercise compared to controls. Strength increased a mean of 33% +/- 4% in exercisers and decreased 2% +/- 2% in controls (p < .0001). In a multiple stepwise regression model, intensity of training was a significant independent predictor of decrease in depression scores (r2 = .617, p = .0002). Conclusions: PRT is an effective antidepressant in depressed elders, while also improving strength, morale, and quality of life.

Research indicates that lower extremity muscle weakness in the elderly is consistently related to impaired mobility and fall risk. Reversible components of the muscle weakness of aging include underuse syndromes and undernutrition, both of which are prevalent in nursing home populations. The Boston FICSIT study is a nursing home-based intervention to improve muscle strength through progressive resistance training of the lower extremities and/or multi-nutrient supplementation in chronically institutionalized subjects aged 70-100. Baseline measurements of falls, medical status, psychological variables, functional status, nutritional intake and status, body composition, muscle mass and morphology, muscle function, and gait and balance are taken. The nursing home residents are then randomly assigned to one of four treatment groups for 10 weeks: (1) high intensity progressive resistance training of the hip and knee extensors 3 days per week; (2) multi-nutrient supplementation with a 360-kcal high carbohydrate, low fat liquid supplement every day; (3) a combination of groups (1) and (2); and (4) a control group. Both non-supplemented groups receive a liquid placebo every day, and both non-exercising groups attend three sessions of "leisure activities" every week in order to control for the attentional aspects of the exercise and nutritional interventions. At the end of the 10-week period, all baseline measurements are re-assessed.

An economic model evaluated the costs and outcomes of adjunctive clobazam therapy for Lennox–Gastaut syndrome (LGS) compared with adjunctive lamotrigine, rufinamide, and topiramate. Clinical data were used to estimate baseline frequency and the percentage of drop-seizure reductions over 3months (all comparators) and 2years (rufinamide). Claims data from a large US health care plan were employed to estimate costs. After 3months, 21.5% of those receiving clobazam were drop-seizure–free. Over a 3-month horizon, clobazam was more effective and less expensive than comparators, with the assumption that >0.77% of drop seizures required medical care. Below this threshold, topiramate was less costly than clobazam. With the base-case assumption that 2.3% of drop seizures were medically attended, costs for patients receiving clobazam totaled $30,147 versus $34,223–$35,378 for comparators. Clobazam was more efficacious and less costly than rufinamide over a 2-year horizon. The percentage of medically attended drop seizures was a driver of results. Clobazam treatment may be cost-saving.