Ayres Sensory Integration Therapy for a Child With Rett Syndrome: A Case Report.

Rett syndrome (RTT) is a neurodevelopmental disorder characterized by severe dyspraxia, hand stereotypies, and sensory processing issues for which there is no known treatment. This case describes a child with classic RTT and the child's responses to an Ayres Sensory Integration (ASI) treatment intervention (36 one-hour sessions, 3 per week). We coded and analyzed 36 detailed treatment notes to answer the following questions: What strategies and factors facilitated or interfered with participation in the intervention? What critical elements of treatment documentation might detect small changes in praxis and participation? How do patterns of motor or praxis milestones that emerge over time relate to this child's level of participation? We observed an increase in participation when the therapist incorporated elements of neurodevelopmental treatment (NDT) and motor learning theory- treatment strategies commonly used with children who have neuromotor conditions. This increase in participation in the ASI intervention emerged at approximately the same time that the therapist documented acquisition of new motor and praxis skills. We observed the importance of using: lateral movement activities to develop weight-shifting and bilateral coordination, rotary play to increase trunk rotation and improve postural transitions, and rhythm to promote continuing or initiating actions. The documentation of the specific amounts of assistance and prompting needed during treatment sessions was an important tool for tracking small yet meaningful responses to treatment. This case illustrates a novel use of ASI intervention supplemented with strategies that developed foundational skills, and the emergence of praxis and participation in the therapeutic intervention. We suggest further research is needed to determine efficacy of ASI for other children with this rare disorder.

High-Deductible Health Plans Paired With Health Savings Accounts Increased Medication Cost Burden Among Individuals With Bipolar Disorder.

Objective: High-deductible health plans paired with health savings accounts (HSA-HDHPs) require substantial out-of-pocket spending for most services, including medications. We examined effects of HSA-HDHPs on medication out-of-pocket spending and use among people with bipolar disorder.Methods: This quasi-experimental study used claims data for January 2003 through December 2014. We studied a national sample of 348 members with bipolar disorder (defined based on International Classification of Diseases, 9th Revision), aged 12 to 64 years, who were continuously enrolled for 1 year in a low-deductible plan (≤ $500) then 1 year in an HSA-HDHP (≥ $1,000) after an employer-mandated switch. HSA-HDHP members were matched to 4,087 contemporaneous controls who remained in low-deductible plans. Outcome measures included out-of-pocket spending and use of bipolar disorder medications, non-bipolar psychotropics, and all other medications.Results: Mean pre-to-post out-of-pocket spending per person for bipolar disorder medications increased by 149.7% among HSA-HDHP versus control members (95% confidence interval [CI], 109.9% to 189.5%). Specifically, out-of-pocket spending increased for antipsychotics (220.9% [95% CI, 150.0% to 291.8%]) and anticonvulsants (109.6% [95% CI, 67.3% to 152.0%]). Both higher-income and lower-income HSA-HDHP members experienced increases in out-of-pocket spending for bipolar disorder medications (135.2% [95% CI, 86.4% to 184.0%] and 164.5% [95% CI, 100.9% to 228.1%], respectively). We did not detect statistically significant changes in use of bipolar disorder medications, non-bipolar psychotropics, or all other medications in this study population of HSA-HDHP members.Conclusions: HSA-HDHP members with bipolar disorder experienced substantial increases in out-of-pocket burdens for medications essential for their functioning and well-being. Although HSA-HDHPs were not associated with detectable reductions in medication use, high out-of-pocket costs could cause financial strain for lower-income enrollees.

Impact of High-Deductible Health Plans on Medication Use Among Individuals With Bipolar Disorder.

OBJECTIVE: High-deductible health plans (HDHPs) require substantial out-of-pocket spending for most services, although medications may be subject to traditional copayment arrangements. This study examined effects of HDHPs on medication out-of-pocket spending and use and quality of care among individuals with bipolar disorder. METHODS: This quasi-experimental study used claims data (2003-2014) for a national sample of 3,532 members with bipolar disorder, ages 12-64, continuously enrolled for 1 year in a low-deductible plan (≤$500) and then for 1 year in an HDHP (≥$1,000) after an employer-mandated switch. HDHP members were matched to 18,923 contemporaneous individuals in low-deductible plans (control group). Outcome measures were out-of-pocket spending and use of bipolar disorder medications, psychotropics for other disorders, and all other medications and appropriate laboratory monitoring for psychotropics. RESULTS: Relative to the control group, annual out-of-pocket spending per person for bipolar disorder medications increased 20.8% among HDHP members (95% confidence interval [CI]=14.9%-26.7%), and the absolute increase was $36 (95% CI=$25.9-$45.2). Specifically, out-of-pocket spending increased for antipsychotics (27.1%; 95% CI=17.4%-36.7%) and anticonvulsants (19.2%; 95% CI=11.9%-26.6%) but remained stable for lithium (-3.7%; 95% CI=-12.2% to 4.8%). No statistically significant changes were detected in use of bipolar disorder medications, other psychotropics, or all other medications or in appropriate laboratory monitoring for bipolar disorder medications. CONCLUSIONS: HDHP members with bipolar disorder experienced a moderate increase in out-of-pocket spending for medications but preserved bipolar disorder medication use. Findings may reflect individuals' perceptions of the importance of these medications for their functioning and well-being.

Affordability of Medical Care Among Medicare Enrollees.

Importance: Cost-sharing requirements can discourage patients from seeking care and impose financial hardship. The Medicare program serves many older and disabled individuals with multimorbidity and limited resources, but little has been known about the affordability of care in this population. Objective: To examine the affordability of medical care among Medicare enrollees, in terms of the prevalence of delaying medical care because of costs and having problems paying medical bills, and risk factors for these outcomes. Design Setting and Participants: Cross-sectional analyses conducted from November 1, 2019, to October 15, 2021, used logistic regression to compare the probability of outcomes by demographic and health characteristics. Data were obtained from the 2017 nationally representative Medicare Current Beneficiary Survey (response rate, 61.7%), with respondents representing 53 million community-dwelling Medicare enrollees. Main Outcomes and Measures: New questions about medical care affordability were included in the 2017 Medicare Current Beneficiary Survey: difficulty paying medical bills, ongoing medical debt, and contact by collection agencies. A companion survey question asked whether individuals had delayed seeking medical care because of worries about costs. Results: Respondents included 10 974 adults aged 65 years or older and 2197 aged 18 to 64 years; 54.2% of all respondents were women. The weighted proportions of Medicare enrollees with annual incomes below $25 000K were 30.7% in the older population and 67.4% in the younger group. Self-reported prevalence of delaying care because of cost was 8.3% (95% CI, 7.4%-9.1%) among enrollees aged 65 years or older, 25.2% (95% CI, 21.8%-28.6%) among enrollees younger than 65 years, and 10.9% (95% CI, 9.9%-11.9%) overall. Similarly, 7.4% (95% CI, 6.6%-8.2%) of older enrollees had problems paying medical bills, compared with 29.8% (95% CI, 25.6%-34.1%) among those younger than 65 years and 10.8% (95% CI, 9.8%-11.9%) overall. Regarding specific payment problems, 7.9% (95% CI, 7.0%-8.9%) of enrollees overall experienced ongoing medical debt, contact by a collection agency, or both. In adjusted analyses, older adults with incomes $15 000 to $25 000 per year had odds of delaying care more than twice as high as those with incomes greater than $50 000 (odds ratio, 2.47; 95% CI, 1.82-3.39), and their odds of problems paying medical bills were more than 3 times as high (odds ratio, 3.37; 95% CI, 2.81-5.21). Older adults with 4 to 10 chronic conditions were more than twice as likely to have problems paying medical bills as those with 0 or 1 condition. Conclusions and Relevance: The findings of this study suggest that unaffordability of medical care is common among Medicare enrollees, especially those with lower incomes, or worse health, or who qualify for Medicare based on disability. Policy reforms, such as caps on patient spending, are needed to reduce Medical cost burdens on the most vulnerable enrollees.

Cost-related Medication Nonadherence and Its Risk Factors Among Medicare Beneficiaries.

BACKGROUND: Unaffordability of medications is a barrier to effective treatment. Cost-related nonadherence (CRN) is a crucial, widely used measure of medications access. OBJECTIVES: Our study examines the current national prevalence of and risk factors for CRN (eg, not filling, skipping or reducing doses) and companion measures in the US Medicare population. RESEARCH DESIGN: Survey-weighted analyses included logistic regression and trends 2006-2016. SUBJECTS: Main analyses used the 2016 Medicare Current Beneficiary Survey. Our study sample of 12,625 represented 56 million community-dwelling beneficiaries. MEASURES: Additional outcome measures were spending less on other necessities in order to pay for medicines and use of drug cost reduction strategies such as requesting generics. RESULTS: In 2016, 34.5% of enrollees under 65 years with disability and 14.4% of those 65 years and older did not take their medications as prescribed due to high costs; 19.4% and 4.7%, respectively, experienced going without other essentials to pay for medicines. Near-poor older beneficiaries with incomes $15-25K had 50% higher odds of CRN (vs. >$50K), but beneficiaries with incomes <$15K, more likely to be eligible for the Part D Low-Income Subsidy, did not have significantly higher risk. Three indicators of worse health (general health status, functional limits, and count of conditions) were all independently associated with higher risk of CRN. CONCLUSIONS: Changes in the risk profile for CRN since Part D reflect the effectiveness of targeted policies. The persistent prevalence of CRN and associated risks for sicker people in Medicare demonstrate the consequences of high cost-sharing for prescription fills.

Experiences of health care costs among people with employer-sponsored insurance and bipolar disorder.

BACKGROUND: Cost-sharing disproportionately affects people with chronic illnesses needing more care. Our qualitative study examined lived experiences navigating insurance benefits and treatment for bipolar disorder, which requires ongoing access to behavioral specialists and psychotropic medications. METHODS: Forty semi-structured telephone interviews with individuals with bipolar disorder and employer-sponsored health insurance, or their family caregivers, explored health care needs, coverage details, out-of-pocket (OOP) costs, and perspectives on value. An iterative analytic approach identified salient themes. RESULTS: Most individuals in our sample faced an annual insurance deductible, from $350-$10,000. OOP costs for specialist visits ranged from $0-$450 and for monthly psychotropic medications from $0-$1650. Acute episodes and care for comorbidities, including medication side effects, added to cost burdens. Medication nonadherence due to OOP costs was rare; respondents frequently pointed to the necessity of medications: "whatever it takes to get those"; "it's a life or death situation." Respondents also prioritized visits to psychiatrist prescribers, though visits were maximally spaced because of cost. Psychotherapy was often deemed unaffordable and forgone, despite perceived need. Interviewees cited limited networks and high out-of-network costs as barriers to specialists. Cost-sharing sometimes led to debt, skimping on nonbehavioral care or other necessities, exacerbated or prolonged mood symptoms, and stress at home. LIMITATIONS: Volunteer respondents may not fully represent the target population. CONCLUSIONS: Many people with bipolar disorder in US employer-sponsored plans experience undertreatment, hardship, and adverse health consequences due to high cost-sharing. More nuanced insurance benefit designs should accommodate the needs of individuals with complex conditions.

Reduced Cost-sharing for Preventive Drugs Preferentially Benefits Low-income Patients With Diabetes in High Deductible Health Plans With Health Savings Accounts.

BACKGROUND: High deductible health plans linked to Health Savings Accounts (HSA-HDHPs) must include all care under the deductible except for select preventive services. Some employers and insurers have adopted Preventive Drug Lists (PDLs) that exempt specific classes of medications from deductibles. OBJECTIVE: The objective of this study was to examine the association between shifts to PDL coverage and medication utilization among patients with diabetes in HSA-HDHPs. RESEARCH DESIGN: A natural experiment comparing pre-post changes in monthly and annual outcomes in matched study groups. SUBJECTS: The intervention group included 1744 commercially-insured HSA-HDHP patients with diabetes age 12-64 years switched by employers to PDL coverage; the control group included 3349 propensity-matched HSA-HDHP patients whose employers offered no PDL. MEASURES: Outcomes were out-of-pocket (OOP) costs for medications and the number of pharmacy fills converted to 30-day equivalents. RESULTS: Transition to the PDL was associated with a relative pre-post decrease of $612 (-35%, P<0.001) per member OOP medication expenditures; OOP reductions were higher for key classes of antidiabetic and cardiovascular medicines listed on the PDL; the policy did not affect unlisted classes. The PDL group experienced relative increases in medication use of 6.0 30-day fills per person during the year (+11.2%, P<0.001); the increase was more than twice as large for lower-income (+6.6 fills, +12.6%, P<0.001) than higher-income (+3.0 fills, +5.1%, P=0.024) patients. CONCLUSION: Transition to a PDL which covers important classes of medication to manage diabetes and cardiovascular conditions is associated with substantial annual OOP cost savings for patients with diabetes and increased utilization of important classes of medications, especially for lower-income patients.

Increases in Suicide Deaths Among Adolescents and Young Adults Following US Food and Drug Administration Antidepressant Boxed Warnings and Declines in Depression Care.

Objective: Studies show decreased depression diagnosis, psychotherapy, and medications and increased suicide attempts following US Food and Drug Administration antidepressant warnings regarding suicidality risk among youth. Effects on care spilled over to older adults. This study investigated whether suicide deaths increased following the warnings and declines in depression care. Methods: We conducted an interrupted time series study of validated death data (1990-2017) to estimate changes in trends of US suicide deaths per 100,000 adolescents (ages 10-19) and young adults (ages 20-24) after the warnings, controlling for baseline trends. Results: Before the warnings (1990-2002), suicide deaths decreased markedly. After the warnings (2005-2017) and abrupt declines in treatment, this downward trend reversed. There was an immediate increase of 0.49 suicides per 100,000 adolescents, 95% confidence interval [CI]: 0.12, 0.86) and a trend increase of 0.03 suicides per 100,000 adolescents per year (95% CI: 0.026, 0.031). Similarly, there was an immediate increase of 2.07 suicides per 100,000 young adults (95% CI: 1.04, 3.10) and a trend increase of 0.05 suicides per 100,000 young adults per year (95% CI: 0.04, 0.06). Assuming baseline trends continued, there may have been 5958 excess suicides nationally by 2010 among yearly cohorts of 43 million adolescents and 21 million young adults. Conclusions: We observed increases in suicide deaths among youth following the warnings and declines in depression care. Alternative explanations were explored, including substance use, economic recessions, smart phone use, and unintentional injury deaths. Additional factors may have contributed to continued increases in youth suicide during the last decade. Combined with previous research on declining treatment, these results call for re-evaluation of the antidepressant warnings.

Sensory Integration and Functional Reaching in Children With Rett Syndrome/Rett-Related Disorders.

BACKGROUND: The loss of functional hand skills is a primary characteristic of Rett syndrome. Stereotypies, dyspraxia, and other sensory processing issues severely limit the individual's ability to reach toward and sustain grasp on objects. This loss of functional reach and grasp severely limits their ability to participate in self-help, play, and school-related activities. We proposed that Ayres Sensory Integration (ASI) treatment would improve sensory processing and motor planning, which would lay the sensory-motor groundwork for improving grasp of objects, an important first step in developing functional hand use. OBJECTIVE: We examined effects of ASI treatment on rate of reaching and grasping for children with Rett syndrome/Rett-related disorders. METHODS: We used an interrupted time series design to measure changes in outcome variables occurring after intervention initiation and cessation. We analyzed daily video observations during baseline, intervention, and post-intervention periods, over a span of 7 months. RESULTS: During baseline, rate of grasping declined moderately. There was a 15% increase in grasping from the end of baseline to end of the post-intervention period. There was no significant change in rate of reaching. CONCLUSIONS: This study provides preliminary data showing very small improvements in hand grasp of children with Rett syndrome following ASI treatment; larger studies in diverse settings are needed to establish the effectiveness of this approach. This study shows that an interrupted time series research design provides a valid template for evaluating interventions for children with rare disorders.

Vulnerable And Less Vulnerable Women In High-Deductible Health Plans Experienced Delayed Breast Cancer Care.

The effects of high-deductible health plans (HDHPs) on breast cancer diagnosis and treatment among vulnerable populations are unknown. We examined time to first breast cancer diagnostic testing, diagnosis, and chemotherapy among a group of women whose employers switched their insurance coverage from health plans with low deductibles ($500 or less) to plans with high deductibles ($1,000 or more) between 2004 and 2014. Primary subgroups of interest comprised 54,403 low-income and 76,776 high-income women continuously enrolled in low-deductible plans for a year and then up to four years in HDHPs. Matched controls had contemporaneous low-deductible enrollment. Low-income women in HDHPs experienced relative delays of 1.6 months to first breast imaging, 2.7 months to first biopsy, 6.6 months to incident early-stage breast cancer diagnosis, and 8.7 months to first chemotherapy. High-income HDHP members had shorter delays that did not differ significantly from those of their low-income counterparts. HDHP members living in metropolitan, nonmetropolitan, predominantly white, and predominantly nonwhite areas also experienced delayed breast cancer care. Policies may be needed to reduce out-of-pocket spending obligations for breast cancer care.

Near Real-time Surveillance for Consequences of Health Policies Using Sequential Analysis.

BACKGROUND: New health policies may have intended and unintended consequences. Active surveillance of population-level data may provide initial signals of policy effects for further rigorous evaluation soon after policy implementation. OBJECTIVE: This study evaluated the utility of sequential analysis for prospectively assessing signals of health policy impacts. As a policy example, we studied the consequences of the widely publicized Food and Drug Administration's warnings cautioning that antidepressant use could increase suicidal risk in youth. METHOD: This was a retrospective, longitudinal study, modeling prospective surveillance, using the maximized sequential probability ratio test. We used historical data (2000-2010) from 11 health systems in the US Mental Health Research Network. The study cohort included adolescents (ages 10-17 y) and young adults (ages 18-29 y), who were targeted by the warnings, and adults (ages 30-64 y) as a comparison group. Outcome measures were observed and expected events of 2 possible unintended policy outcomes: psychotropic drug poisonings (as a proxy for suicide attempts) and completed suicides. RESULTS: We detected statistically significant (P<0.05) signals of excess risk for suicidal behavior in adolescents and young adults within 5-7 quarters of the warnings. The excess risk in psychotropic drug poisonings was consistent with results from a previous, more rigorous interrupted time series analysis but use of the maximized sequential probability ratio test method allows timely detection. While we also detected signals of increased risk of completed suicide in these younger age groups, on its own it should not be taken as conclusive evidence that the policy caused the signal. A statistical signal indicates the need for further scrutiny using rigorous quasi-experimental studies to investigate the possibility of a cause-and-effect relationship. CONCLUSIONS: This was a proof-of-concept study. Prospective, periodic evaluation of administrative health care data using sequential analysis can provide timely population-based signals of effects of health policies. This method may be useful to use as new policies are introduced.

Counter-Point: Early Warning Systems Are Imperfect, but Essential.

Sequential analysis can be used as an early warning system about potential unintended consequences of health policy decisions, generating follow-up investigations, but it should not be used as causal evidence.

Counter-Point: Staying Honest When Policy Changes Backfire.

Despite the good intentions of the Food and Drug Administration (FDA), many drug warnings are ineffective or have unintended consequences, particularly if the media exaggerates the messages and scares the public. The controversial 2003 to 2004 FDA warnings on youth suicidality associated with antidepressant use are a case in point. In a 10-year interrupted time series (ITS) analysis in 11 health plans, we found that the warnings and hyped media coverage led to substantial reductions in antidepressant use (declines in antidepressant use and overall care corroborated in several studies), and small, visible increases in emergency room and inpatient poisonings with psychotropic drugs. In a gross misunderstanding of the method, Dr Stone calls ITS, "an intuition based upon false analogies, fallacious assumptions and analytical error." We demonstrate visually using published studies that the ITS method is one of the oldest (hundreds of years) and strongest quasi-experimental study designs, and that the alternative data analyses proposed by Dr Stone do not have rates (denominators), nor baselines, so the measures of change are invalid.

Breast Cancer Diagnosis and Treatment After High-Deductible Insurance Enrollment.

Purpose High-deductible health plans (HDHPs) require substantial out-of-pocket spending and might delay crucial health services. Breast cancer treatment delays of as little as 2 months are associated with adverse outcomes. Methods We used a controlled prepost design with survival analysis to assess timing of breast cancer care events among 273,499 women age 25 to 64 years without evidence of breast cancer before inclusion. Women were included if continuously enrolled for 1 year in a low-deductible ($0 to $500) plan followed by up to 4 years in a HDHP (at least $1,000 deductible) after an employer-mandated switch. Study inclusion was on a rolling basis, and members were followed between 2003 and 2012. The comparison group comprised 2.4 million contemporaneously matched women whose employers offered only low-deductible plans. Measures were times to first diagnostic breast imaging (diagnostic mammogram, breast ultrasound, or breast magnetic resonance imaging), breast biopsy, incident early-stage breast cancer diagnosis, and breast cancer chemotherapy. Outcomes were analyzed by using Cox models and adjusted for age-group, morbidity score, poverty level, US region, index date, and employer size. Results After the index date, HDHP members experienced delays in receipt of diagnostic imaging (adjusted hazard ratio [aHR], 0.95; 95% CI, 0.94 to 0.96), biopsy (aHR, 0.92; 95% CI, 0.89 to 0.95), early-stage breast cancer diagnosis (aHR, 0.83; 0.78 to 0.90), and chemotherapy initiation (aHR, 0.79; 95% CI, 0.72 to 0.86) compared with the control group. Conclusion Women switched to HDHPs experienced delays in diagnostic breast imaging, breast biopsy, early-stage breast cancer diagnosis, and chemotherapy initiation. Additional research should determine whether such delays cause adverse health outcomes, and policymakers should consider selectively reducing out-of-pocket costs for key breast cancer services.

Effect of High-Deductible Insurance on High-Acuity Outcomes in Diabetes: A Natural Experiment for Translation in Diabetes (NEXT-D) Study.

OBJECTIVE: High-deductible health plans (HDHPs) are now the predominant commercial health insurance benefit in the U.S. We sought to determine the effects of HDHPs on emergency department and hospital care, adverse outcomes, and total health care expenditures among patients with diabetes. RESEARCH DESIGN AND METHODS: We applied a controlled interrupted time-series design to study 23,493 HDHP members with diabetes, aged 12-64, insured through a large national health insurer from 2003 to 2012. HDHP members were enrolled for 1 year in a low-deductible (≤$500) plan, followed by 1 year in an HDHP (≥$1,000 deductible) after an employer-mandated switch. Patients transitioning to HDHPs were matched to 192,842 contemporaneous patients whose employers offered only low-deductible coverage. HDHP members from low-income neighborhoods (n = 8,453) were a subgroup of interest. Utilization measures included emergency department visits, hospitalizations, and total (health plan plus member out-of-pocket) health care expenditures. Proxy health outcome measures comprised high-severity emergency department visit expenditures and high-severity hospitalization days. RESULTS: After the HDHP transition, emergency department visits declined by 4.0% (95% CI -7.8, -0.1), hospitalizations fell by 5.6% (-10.8, -0.5), direct (nonemergency department-based) hospitalizations declined by 11.1% (-16.6, -5.6), and total health care expenditures dropped by 3.8% (-4.3, -3.4). Adverse outcomes did not change in the overall HDHP cohort, but members from low-income neighborhoods experienced 23.5% higher (18.3, 28.7) high-severity emergency department visit expenditures and 27.4% higher (15.5, 39.2) high-severity hospitalization days. CONCLUSIONS: After an HDHP switch, direct hospitalizations declined by 11.1% among patients with diabetes, likely driving 3.8% lower total health care expenditures. Proxy adverse outcomes were unchanged in the overall HDHP population with diabetes, but members from low-income neighborhoods experienced large, concerning increases in high-severity emergency department visit expenditures and hospitalization days.