Commercial Coverage Research Articles

Air pollution and the mystery of high household savings in China

Despite consumption being a key measure of residential welfare, the relationship of the residential savings rates, an inverse proxy for household consumption, with air pollution is unclear. This study empirically examines the impact of air pollution on household savings rates, and the underlying mechanism. The results reveal that worsening air pollution significantly increases household savings rates; this finding holds under alternative variable specifications and employing instrumental variables to address endogeneity issues. The mechanism analysis demonstrates that air pollution enhances household savings rates through health risks. Heterogeneity analysis indicates that in developed areas with more comprehensive public medical service systems, the positive effect of air pollution on household savings rates weakens in second-tier cities and above as well as in high-income areas. Furthermore, improvements in commercial insurance coverage mitigates the positive effect of air pollution on household savings rates. Overall, this study explains the high savings phenomenon among Chinese households from an environmental perspective. The Chinese government should encourage the use of renewable energy, improve air pollution control, and reduce the inhibitory effects of air pollution on residential consumption.

Commercial Insurance Coverage Criteria for Autologous Chondrocyte Implantation Poorly Reflect Current Research.

The aim of this study is to both quantify and qualify the way insurance companies justify their coverage policies for autologous chondrocyte implantation (ACI) and determine whether these policies align with recent research on the subject. The top 11 national commercial health insurance payers for ACI were identified. Coverage policy documents were recovered for 8 payers. These documents were examined, and the type of reference and the level of evidence (LOE) were recorded for each applicable reference. Specific coverage criteria for each individual payer were then extracted and assessed for similarities among commercial payers. Finally, all references cited by each payer were examined to determine whether they mentioned the specific payer criteria. This study found that the majority of cited references were primary journal articles (86, 58.1%) and that only 30 (20.2%) references were level I or level II evidence. This study also found significant homogeneity among payer coverage criteria. Cited sources inconsistently mentioned specific payer coverage criteria. In addition, payer criteria tended to be poorly supported by current evidence on ACI. This study demonstrates that commercial insurance payers' coverage policies for ACI poorly cite references, cite a majority of references with low LOE, and cite references which infrequently mention their specific coverage criteria. In addition, payer coverage policies have a high degree of homogeneity and many of their specific criteria are poorly supported by current research on ACI.

State Out-Of-Pocket Caps On Insulin Costs: No Significant Increase In Claims Or Utilization.

Nearly all patients with type 1 diabetes and 20-30percent of patients with type 2 diabetes use insulin to manage glycemic control. Approximately one-quarter of patients who use insulin report underuse because of cost. In response, more than twenty states have implemented monthly caps on insulin out-of-pocket spending, ranging from $25 to $100. Using a difference-in-differences approach, this study evaluated whether state-level caps on insulin out-of-pocket spending change insulin usage among commercially insured enrollees. The study included 33,134 people ages18-64 who had type 1 diabetes or who used insulin to manage type 2 diabetes with commercial insurance coverage that was subject to state-level oversight and was included in the 25percent sample of the IQVIA PharMetrics database during 2018-21. Insulin out-of-pocket caps did not significantly increase quarterly insulin claims for enrollees who had type 1 diabetes or who used insulin to manage type 2 diabetes. State-level caps on insulin out-of-pocket spending for commercial enrollees did not significantly increase insulin use; that may be in part because of out-of-pocket expenses being lower than cap amounts.

Predictive Modeling of Future Trends in US Healthcare Data and Outcomes

Predictive modeling has great potential to help guide healthcare policymaking and planning through forecasting future trends in domains such as disease prevalence, resource utilization, and costs. However, past research in this area has been limited by mostly examining small, narrow datasets that only captured specific illnesses or geographic regions. This study aimed to leverage more sophisticated predictive analytics to generate informed estimations of the most consequential healthcare trends anticipated in the United States throughout the next decade. The analysis drew upon an extensive collection of over 50 million longitudinal electronic health records spanning a 5-year timeframe, comprehensive national public health statistics from the same period, and Medicare claims encompassing 72 million beneficiaries. Advanced machine learning techniques, including neural networks and Bayesian additive regression trees, were applied to identify nonlinear relationships and temporal patterns across 500 variables related to patient demographics, medical diagnoses, therapeutic procedures, reimbursement amounts, and clinical outcomes. Models were trained using data from 2010 to 2015 then utilized to project trends and forecasts for the years 2020 to 2025. Five-fold cross-validation testing was conducted to evaluate the accuracy and generalizability of the predictive models. The model projections indicate that chronic disease prevalence nationwide will rise by approximately 40% by the conclusion of 2025, primarily fueled by growing epidemics of obesity and an increasingly aging American population. Additionally, heart disease and stroke are estimated to maintain their positioning as leading causes of death, but cases of dementia and Alzheimer's disease specifically are projected to climb even more sharply at over a 50% increase. Healthcare costs on the whole are anticipated to rise on average between 4-6% annually, and costs may potentially double for elderly patients presenting with multiple morbidities. As outpatient and home-based care options expand further, inpatient hospital facility utilization may drop marginally between 10-15%. Improved management of chronic medical conditions within local community settings could reduce preventable hospital readmissions from 25-30%. Primary care, nursing, and mental healthcare roles are likely to face looming staffing shortages as well. Telehealth adoption is forecasted to surge by approximately 45% as virtual visit formats help address access obstacles. By 2025, biologics and gene therapies could account for over 25% of total drug spending pertaining to oncology and rare disease treatment. Larger Medicaid, Medicare, and ACA commercial coverage markets may motivate higher rates of health insurance enrollment over the next few years.

HPR84 Variation in Commercial Coverage of Accelerated Approval Drugs

HPR84 Variation in Commercial Coverage of Accelerated Approval Drugs

Characteristics of a transgender and gender-diverse patient population in Utah: Use of electronic health records to advance clinical and health equity research.

Transgender and gender-diverse (TGD) people, individuals whose gender identity differs from their sex assigned at birth, face unique challenges in accessing gender-affirming care and often experience disparities in a variety of health outcomes. Clinical research on TGD health is limited by a lack of standardization on how to best identify these individuals. The objective of this retrospective cohort analysis was to accurately identify and describe TGD adults and their use of gender-affirming care from 2003-2023 in a healthcare system in Utah, United States. International Classification of Disease (ICD)-9 and 10 codes and surgical procedure codes, along with sexual orientation and gender identity data were used to develop a dataset of 4,587 TGD adults. During this time frame, 2,985 adults received gender-affirming hormone therapy (GAHT) and/or gender-affirming surgery (GAS) within one healthcare system. There was no significant difference in race or ethnicity between TGD adults who received GAHT and/or GAS compared to TGD adults who did not receive such care. TGD adults who received GAHT and/or GAS were more likely to have commercial insurance coverage, and adults from rural communities were underrepresented. Patients seeking estradiol-based GAHT tended to be older than those seeking testosterone-based GAHT. The first GAS occurred in 2013, and uptake of GAS have doubled since 2018. This study provides a methodology to identify and examine TGD patients in other health systems and offers insights into emerging trends and access to gender-affirming care.

Association of Very Low Birth Weight Infants With Parental and Sibling Mental Health Care Usage.

Parents and siblings of very low birth weight, premature infants are at risk for poor mental health outcomes with increased mental health care usage. Knowledge regarding mental health care use patterns could guide interventions. This retrospective cohort study included US families with commercial insurance coverage from a single carrier. Neonates born at ≤30 weeks' gestational age or with a birth weight <1500 g were identified by insurance claim data between July 1, 2015, and June 30, 2016. Each case neonate family was matched with up to 4 control families. The study included 1209 case and 1884 control neonates (with 134 deaths among only the case neonates [11.1% of cases]); 2003 case and 3336 control parents (mean [SD] age, 34.6 [5.4] years; 2858 [53.5%] female); and 884 case and 1878 control siblings (mean [SD] age, 6.8 [5.5] years; 1375 [49.8%] female). Compared with controls, more case parents used mental health care over the first year after birth hospitalization discharge. Higher usage was observed for bereaved case parents soon after their child's death. A smaller proportion of bereaved case siblings received mental health care compared with controls. Although nonbereaved case parents returned toward the proportion of use observed in controls, nonbereaved case female siblings, bereaved case female and male siblings, and bereaved male parents experienced continued differences. Understanding and meeting the mental health care needs of parents and siblings of very low birth weight premature neonates can be guided by these findings, including elevated and prolonged needs of bereaved parents and siblings.

Anatomic Total Shoulder: Predictors of Excellent Outcomes at Five Years after Arthroplasty.

The objectives of this study were to: report minimum 5-year outcomes in patients undergoing TSA and determine characteristics predictive of patients achieving an excellent functional outcome. Pre-operative demographic variables and Simple Shoulder Test (SST) scores were obtained pre-operatively and at a minimum of fiveyears after surgery. A final SST ≥ 10 and percentage of maximal possible improvement (% MPI) of ≥ 66.7% were determined to be the thresholds for excellent outcomes. Univariate and multivariate analysis were performed to identify factors associated with excellent fiveyear clinical outcomes. Of 233 eligible patients, 188 (81%) had adequate follow-up for inclusion in this study. Mean SST scores improved from 3.4 ± 2.4 to 9.7 ± 2.2 (p < 0.001). Male sex was an independent predictor of both SST ≥ 10 (OR 3.46, 95% CI 1.70-7.31; p < 0.001) and %MPI ≥ 66.7 (OR 2.27, 95% CI 1.11-4.81, p = 0.027). Workers' Compensation insurance was predictive of not obtaining SST ≥ 10 (OR 0.12, 95% 0.02-0.60; p = 0.016) or %MPI ≥ 66.7 (OR 0.16, 95% CI 0.03-0.77, p = 0.025). MCID was passed by the vast majority (95%) of patients undergoing TSA and did not necessarily indicate an excellent, satisfactory outcome. Male sex and commercial insurance coverage were significantly associated with these excellent outcomes, while Workers' Compensation insurance was associated with failure to achieve this result. Thresholds for excellent outcomes, such as final SST ≥ 10 and %MPI ≥ 66.7, may be useful in identifying the characteristics of patients who benefit most from TSA.

Incidence of pneumococcal disease in children ≤48 months old in the United States: 1998–2019

BackgroundPneumococcal disease (PD) is a major cause of morbidity and mortality among children, particularly in the youngest age groups. This study aimed to assess the incidence of PD over time by age group in young children with commercial or Medicaid coverage in the US. MethodsEpisodes of invasive pneumococcal disease (IPD), all-cause pneumonia (ACP), and acute otitis media (AOM) were identified in the MarketScan® Commercial and Medicaid claims databases using diagnosis codes among children aged ≤ 48 months with confirmed date of birth (DoB), at any time during the study period (1998–2019). DoB was assigned using diagnosis codes for birth or delivery using the child’s or mother’s medical claims to ensure accurate age determination. Annual incidence rates (IRs) were calculated as number of disease episodes/100,000 person-years (PY) for IPD and ACP and episodes/1,000 PY for AOM, for children aged 0–6, 7–12, 12–24, and 25–48 months. ResultsAnnual IPD IRs declined from 53 to 7 episodes/100,000 PY between 1998 and 2019 in commercially-insured and 58 to 9 episodes/100,000 PY between 2001 and 2019 in Medicaid-insured children. Annual ACP IRs declined from 5,600 to 3,952 episodes/100,000 PY, and from 6,706 to 4,521 episodes/100,000 PY, respectively, over these periods. In both populations, children aged 0–6 months had the highest incidence of IPD and inpatient ACP. Annual AOM IRs declined from 1,177 to 738 episodes/1,000 PY (commercially-insured) and 633 to 624 episodes/1,000 PY (Medicaid-insured), over these periods. IRs were higher in rural vs. urban areas for all disease manifestations. ConclusionsIncidence rates of IPD, ACP, and AOM decreased in children with commercial insurance and Medicaid coverage from 1998 to 2019. However, burden of disease remained substantial, with higher annual IRs for IPD and ACP for Medicaid-insured vs. commercially-insured children. IPD and inpatient ACP were most common in the youngest children 0–6 months old, followed by the 7–12-month age group.

Continuous Medicaid Eligibility During the COVID-19 Pandemic and Postpartum Coverage, Health Care, and Outcomes

Pursuant to the Families First Coronavirus Response Act (FFCRA), continuous Medicaid eligibility during the COVID-19 public health emergency (PHE) created a de facto national extension of pregnancy Medicaid eligibility beyond 60 days postpartum. To evaluate the association of continuous Medicaid eligibility with postpartum health insurance, health care use, breastfeeding, and depressive symptoms. This cohort study using a generalized difference-in-differences design included 21 states with continuous prepolicy (2017-2019) and postpolicy (2020-2021) participation in the Pregnancy Risk Assessment Monitoring System (PRAMS). State-level change in Medicaid income eligibility after 60 days postpartum associated with the FFCRA measured as a percent of the federal poverty level (FPL; ie, the difference in 2020 income eligibility thresholds for pregnant people and low-income adults/parents). Health insurance, postpartum visit attendance, contraceptive use (any effective method; long-acting reversible contraceptives), any breastfeeding and depressive symptoms at the time of the PRAMS survey (mean [SD], 4 [1.3] months postpartum). The sample included 47 716 PRAMS respondents (64.4% aged <30 years; 18.9% Hispanic, 26.2% non-Hispanic Black, 36.3% non-Hispanic White, and 18.6% other race or ethnicity) with a Medicaid-paid birth. Based on adjusted estimates, a 100% FPL increase in postpartum Medicaid eligibility was associated with a 5.1 percentage point (pp) increase in reported postpartum Medicaid enrollment, no change in commercial coverage, and a 6.6 pp decline in uninsurance. This represents a 40% reduction in postpartum uninsurance after a Medicaid-paid birth compared with the prepolicy baseline of 16.7%. In subgroup analyses by race and ethnicity, uninsurance reductions were observed only among White and Black non-Hispanic individuals; Hispanic individuals had no change. No policy-associated changes were observed in other outcomes. In this cohort study, continuous Medicaid eligibility during the COVID-19 PHE was associated with significantly reduced postpartum uninsurance for people with Medicaid-paid births, but was not associated with postpartum visit attendance, contraception use, breastfeeding, or depressive symptoms at approximately 4 months postpartum. These findings, though limited to the context of the COVID-19 PHE, may offer preliminary insight regarding the potential impact of post-pandemic postpartum Medicaid eligibility extensions. Collection of longer-term and more comprehensive follow-up data on postpartum health care and health will be critical to evaluating the effect of ongoing postpartum policy interventions.

Implementation of a Pharmacist-Led, Long-Acting, Injectable Cabotegravir/Rilpivirine Program for HIV-1 at Health System-Based Clinics in the New York Metropolitan Area.

Long-acting cabotegravir/rilpivirine (LA-CAB/RPV) is the first complete injectable antiretroviral for patients living with HIV. To facilitate patient access to long-acting injectable treatment, a system-wide, pharmacist-led, LA-CAB/RPV transition program was developed at four health system-based New York clinics. Provider referrals were received across four clinics between January 22nd, 2021, and December 31st, 2022. All referrals were evaluated by a pharmacist for clinical eligibility and medication access. The primary outcome was the treatment retention rate defined as the percentage of patients who remained on LA-CAB/RPV at 3 months post-transition. A total of 171 referrals were received, with 73 patients (43%) initiating LA-CAB/RPV. Baseline demographics included a median age of 38 years, 81% patients were male, 41% were African American, and 49% had commercial insurance coverage. The treatment retention rate was 90% at 3 months post-transition. By the end of the study period, 84% of patients who transitioned remained on LA-CAB/RPV. Treatment was discontinued due to reasons such as viral breakthrough (4%), emergence of mutations (4%), and intolerable side effects (4%). Injection site reactions were commonly reported (51%), but only resulting in treatment discontinuation for one patient. A pharmacist-led program can transition a diverse population of patients living with HIV to LA-CAB/RPV. Results from this study further add to clinical experiences with LA-CAB/RPV, demonstrating real-world treatment retention despite more frequent clinic visits for patients.

Gender dysphoria and gender-affirming surgery: The New York state experience

Transgender and gender nonconforming (TGNC) individuals experience incongruence between their self-identified gender versus their birth-assigned sex. In some cases, TGNC patients undergo gender-affirming surgical (GAS) procedures. Although GAS is an evolving surgical field, there is currently limited literature documenting patient characteristics and procedures. Addressing this knowledge gap, this retrospective cohort analysis described the characteristics of New York State's TGNC residents with gender dysphoria (GD) diagnosis, including patients undergoing at least one gender-affirming surgical procedure. Using the New York Statewide Planning and Research Cooperative System (SPARCS) database from 2002 to 2018, we identified patients' first-time TCNC records and their risk characteristics. Patients who received GAS procedures were sub-classified as top-only, bottom-only, or combined top/bottom procedures and were compared with TGNC patients who did not receive GAS. Of 24,615 records extracted from TGNC SPARCS database, 11,427 (46.4%) were transmasculine (female-to-male) and 13,188 (53.6%) were transfeminine (male-to-female). Overall, 2.73% of transgender patients received at least one GAS procedure. Of these patients, 78.2% had masculinizing and 21.8% had feminizing surgeries. After a diagnosis of GD, the positive predictors for a GAS-based procedure included female birth sex, pediatric age (<18 years) or older age (60+ years), commercial insurance coverage, and Hispanic race. In contrast, negative GAS predictors included male birth sex and government insurance coverage (i.e., Medicare and Medicaid). Compared with transgender women, transgender men were more likely to receive at least one GAS procedure. Because the race, ethnicity, and payor status of TGNC patients can impact GAS treatment rates, additional research is warranted to examine post-diagnosis GAS treatment disparities among TGNC patients.

IMPACT OF PATIENT DEMOGRAPHICS, CLINICAL CHARACTERISTICS, AND SOCIAL DETERMINANTS OF HEALTH ON ADVANCED THERAPY MEDICATION ADHERENCE AND PERSISTENCE IN ULCERATIVE COLITIS ACROSS UNITED STATES PAYER TYPES

Abstract INTRODUCTION Social determinants of health (SDOH) factors such as insurance status, race, ethnicity, and socioeconomic status have been associated with clinical outcomes in ulcerative colitis (UC). We assessed the impact of demographic, clinical, and SDOH factors on advanced therapy medication adherence and persistence in patients (pts) with UC. METHODS Pts with UC who initiated an advanced therapy (Janus kinase inhibitor, sphingosine-1-phosphate receptor agonist, or biologic) were identified using Commercial and Medicaid Managed Care (MMC) claims data from the MORE2 Registry (2017–2022) and Medicare Fee-for-Service (FFS) (2017–2021) claims. Community-level SDOH variables were linked using pt ZIP codes at index date (first advanced UC therapy prescription date from May 01, 2018 up to Jun 30, 2021). Adherence (proportion of days covered [PDC]) and persistence (duration) of treatment were assessed for 1 year post-index. Logistic regression analyses evaluated the associations between demographic, clinical, and SDOH factors and adherence/persistence. RESULTS The number of pts included in the Medicare FFS, Commercial, and MMC plan types were 9,158, 6,706, and 3,170, respectively. Mean PDC were 69%, 72%, and 64% (Fig. a), respectively, and the corresponding proportions of pts with 1-year persistence were 53%, 43%, and 31%, respectively (Fig. b). PDC by percentile is shown in Fig. c. Female pts had lower odds of adherence vs male pts in the Medicare FFS plan only (odds ratio [OR] 0.89; Table). A higher Charlson Comorbidity Index Score was associated with lower odds of adherence in the Medicare FFS and Commercial plans only (OR for both: 0.94; Table). In the 1 year post-index period, a corticosteroid prescription was associated with lower odds of adherence across plan types (OR 0.57–0.66; Table); a 5-aminosalicylic acid prescription was associated with higher odds of adherence in the Medicare FFS and Commercial plans only (OR 1.12–1.15; Table). A mental health condition diagnosis in the 1 year prior to and post-index was associated with lower adherence vs those without among pts with Medicare FFS and Commercial coverage (OR 0.85–0.87; Table). Community-level SDOH variables assessed had no association with adherence (Table); persistence model results were similar (data not shown). CONCLUSION For pts initiating an advanced therapy, there are still unmet treatment needs as demonstrated by mean PDC &amp;lt;80% and full persistence ≤53% across plan types. Adherence and persistence were lower among pts on MMC vs Medicare FFS or Commercial plans. The impact of demographic variables on adherence varied depending on plan type. Higher comorbidity burden, mental health diagnosis, and concomitant steroid use were generally associated with lower adherence to advanced UC therapies. Community-level SDOH variables were not associated with adherence in these populations.

Ketamine for Adults With Treatment-Resistant Depression or Posttraumatic Stress Disorder: A 2023 Update

What Is the Issue?&#x0D; &#x0D; Many drug treatments are available for depression, but 22% of people in Canada with the condition have treatment-resistant depression (TRD). For people with TRD, standard drug treatments do not improve their symptoms or do not work for long, and their depression persists.&#x0D; Posttraumatic stress disorder (PTSD) is a disabling mental health condition that affects about 9% of people in Canada in their lifetime. Few drugs are available for treating PTSD, none of which are considered effective.&#x0D; Ketamine is a hallucinogenic drug used primarily for anesthesia. Ketamine has also been explored for other indications, such as TRD and PTSD, generating questions about whether it could be a treatment option for these conditions.&#x0D; &#x0D; What Did We Do?&#x0D; &#x0D; We conducted a review of the clinical effectiveness, cost-effectiveness, and evidence-based guidelines on the use of ketamine in adults with TRD or PTSD, to help guide decisions on the use of ketamine for managing these conditions.&#x0D; An information specialist conducted a search of peer-reviewed and grey literature sources published in March 2022 or later. One reviewer screened citations and selected and critically appraised the included studies.&#x0D; CADTH engaged a patient with lived experience of TRD who shared their experiences and perspectives on ketamine-assisted psychotherapy. These perspectives helped us to contextualize the literature and appreciate nuances of the experience.&#x0D; &#x0D; What Did We Find?&#x0D; &#x0D; Ketamine could lead to an immediate improvement in depressive symptoms and suicidal ideation compared to placebo or midazolam in adults with TRD. The longest follow-up was 90 days, and the longest lasting effect after a dose was 28 days. Serious side effects of ketamine — such as dissociation — were rare and short-lived, lasting hours, in adults with TRD.&#x0D; It is uncertain if ketamine is an effective and safe treatment for symptoms of PTSD, due to little to no evidence suggesting its effectiveness or safety against placebo, midazolam, or opioids.&#x0D; Most studies evaluated ketamine given intravenously, and we found limited evidence on intramuscular (IM), subcutaneous, and intranasal routes of administration. We found no studies on oral or sublingual administration of ketamine and no studies comparing the different ways that ketamine can be given for TRD or PTSD.&#x0D; An economic evaluation found that IV ketamine was likely to be cost-effective compared to intranasal esketamine in adults with TRD from a health care perspective in the US. However, from a patient perspective, IV ketamine was unlikely to be cost-effective compared to esketamine, due to comparable levels of clinical effectiveness and lower costs of esketamine attributable to commercial insurance coverage and manufacturer assistance programs.&#x0D; A US guideline on TRD suggests ketamine as augmentation to antidepressants. A US guideline on PTSD does not suggest the use of ketamine as therapy.&#x0D; The patient contributor CADTH engaged for this review highlighted the benefits, stigma, and barriers of ketamine therapy, including financial implications.&#x0D; &#x0D; What Does This Mean?&#x0D; &#x0D; There is some clinical effectiveness and cost-effectiveness evidence and a guideline recommendation to support the short-term use of ketamine in adults with TRD.&#x0D; Clinical effectiveness evidence and a guideline recommendation do not support the use of ketamine in adults with PTSD.&#x0D; Future research is necessary to understand the effectiveness and safety of ketamine as therapy for TRD in larger populations over longer periods and for PTSD for any follow-up duration.&#x0D; Decision-makers should consider offering ketamine in an equitable manner.&#x0D;

Healthcare cost and utilization for chimeric antigen receptor (CAR) T-cell therapy in the treatment of pediatric acute lymphoblastic leukemia: A commercial insurance claims database analysis.

B-lineage acute lymphoblastic leukemia (B-ALL) is the most common malignancy of childhood. With the introduction of novel cellular therapies, cost of care is a critical component and the financial burden experienced by patients and society requires evaluation. This study aims to assess the utilization and cost of care for chimeric antigen receptor T-cell (CAR-T) therapy for pediatric ALL patients with commercial insurance coverage in the United States. Using de-identified commercial insurance data from the OptumLabs® Data Warehouse, a cohort of 37 patients, aged 1-25 years, with B-ALL treated with CAR-T therapy between Oct 2016 and Dec 2021 in the United States was identified. Cost was evaluated for a 90 day period encompassing CAR-T infusion and by administration and complication characteristics. Among the 37 identified B-ALL patients that received a CAR-T product infusion, 14 patients were female, median age at administration was 13 years. The median 90-day total cost was $620,500 (Mean: $589,108). Inpatient cost accounted for approximately 71% of the total cost with an average of 28 inpatient days per patient. Although inpatient cost was slightly higher in the older age group (aged 10-25 years) and in patients with a code for cytokine release syndrome (CRS), these differences were not statistically significant. This real-world cost analysis shows for the first time the encompassing cost of CAR-T therapy for pediatric B-ALL patients in the US with commercial insurance. This study provides a valuable benchmark that can be used to analyze the financial implications of CAR-T therapy for pediatric B-ALL therapy on health systems.

Prescription drug spending by payer: Implications for managed care

BackgroundBrand-name prescription drugs are an important driver of prescription drug spending, but different payers may bear these costs differentially necessitating different policy goals for each payer. But little is known about how the top 10 selling drugs in the U.S. impact spending across payers. ObjectiveTo estimate the differential spending burden of top prescription drugs on Medicaid, Medicare, commercial coverage, and out-of-pocket (OOP) spending. MethodsThe percentage of total prescription drug spending, total spending, total prescriptions, and average cost per prescription overall and for each of the following payers – Medicaid, Medicare, private insurance, and OOP – was calculated for each of the top 10 selling prescription drugs using 2017–2019 Medical Expenditure Panel Survey data. ResultsThese 10 prescription drugs accounted for average annual spending of $83.4 billion and 19.0% of all prescription drug spending. Medicare tended to contribute the highest fraction of spending. The average annual cost per prescription ranged from $500 for Advair to $7400 for Tecfidera. Significant variation in the average annual number of prescriptions filled was observed, ranging from 1.4 million for Tecfidera to 13.6 million for Lantus. ConclusionsThe findings highlight the significant impact of the top 10 selling prescription drugs on U.S. prescription drug spending. The wide variation in per prescription cost as well as contribution to each payer's prescription drug burden emphasizes how policies targeting top-selling drugs may differentially impact payers as well as how payer-specific policies may differ substantially even for top selling drugs.

A Multi-State Analysis of the Fiscal Impact of Commercial Insurance Coverage for General-Use &amp; Activity-Specific Prosthetic &amp; Orthotic Devices in the United States

Prosthetic and orthotic devices are assistive devices utilized by individuals with limb loss, limb difference, and mobility impairment. Research has shown these devices improve mobility and functionality, independence, and overall quality of life for individuals with disabilities who depend on them. This report focuses on two use types of prosthetic and orthotic devices: general-use and activity-specific. General-use prostheses and orthoses are designed to achieve the basic needs of ambulation and upper-limb functionality. In contrast, activity-specific devices are designed to support higher-intensity physical activities and recreation. Currently, 29 states do not require insurance coverage for general-use prosthetic and orthotic devices, and 45 states do not require insurance coverage for activity-specific devices, hindering individuals with limb loss, limb difference, and mobility impairment from essential life functions, including regular exercise required to prevent chronic illnesses. This study analyzes proposed legislation in 11 states, aiming to expand state-regulated coverage for prosthetic and orthotic devices for the purpose of improving quality of life and longevity of health, including chronic illness prevention. The methodology includes estimating the per member per month (PMPM) and net cost variations per state based on U.S. Census populations, Center of Medicare and Medicaid Services (CMS) Public Use Data Files and state-specific Medicaid fee schedules. The authors hypothesize that expanded insurance coverage could yield long-term social and fiscal benefits to the patient and healthcare systems. Results show PMPM estimates for states pursuing various levels of coverage, encompassing both general-use and activity-specific devices. The analysis conservatively estimates small PMPM increases based on assumptions related to device coverage costs and utilization. The results further emphasize potential overall healthcare savings from insurance coverage for these devices with the implementation of the 11 legislative initiatives, from improved health outcomes, with minimal fiscal impact.

Association between hospital volume, clinical events, resource utilization, and costs of septal myectomy and alcohol septal ablation procedures in US patients with hypertrophic cardiomyopathy

Abstract Background Prior studies have evaluated the relationship between hospital procedural volumes of septal reduction therapies (SRT) for obstructive hypertrophic cardiomyopathy (HCM) and outcomes. Other analyses, including economic outcomes, are needed to support clinical decisions among adult patients diagnosed with HCM. Objective The objective of this study was to reconfirm the relationship between higher SRT procedural volume, including septal myectomy (SM) -with and without mitral valve repair or replacement (MVRR)- and alcohol septal ablation (ASA), and clinical events, healthcare resource utilization, and hospitalization costs using more contemporary hospitalization data. Data &amp; Methods This cross-sectional study utilizes retrospective observational data from the PINC AI™ Healthcare Database (PHD), a US hospital administrative database. The study population consists of adult patients with HCM undergoing ASA or SM procedures between January 1, 2012, and March 31, 2022. Hospital volume was determined by tertiles of total SRT performed for ASA, SM separately during the study period. We compare clinical events (including death, stroke, acute renal failure, and pacemaker implantation), readmission, index length of stay, and hospitalization costs across tertiles. We present p-values between tertiles and within procedure types. Results A total of 3,068 adult HCM patients in 315 US hospitals underwent SRT during the study period, including 1,400 with ASA and 1,668 with SM. Table 1 shows the patient and hospital characteristics by tertiles of hospital volume. The median age of patients was 66 years for ASA and 62 years for SM. Medicare coverage accounted for 59.9% of ASA and 44.9% of SM, followed by commercial coverage (28.5% of ASA and 39% of SM). Most hospitals in the study were teaching hospitals (74% for ASA and 67% for SM). In the highest SRT volume tertile (5% of hospitals performing SRT) the average annual number of procedures was 3.5 ASA and 4.9 SM. Table 2 presents the outcomes by hospital volume (low-, mid-, and high-volume). Recorded in-hospital death rates for ASA were 1.4%, 1.4%, and 1.1%, respectively (not statistically different); for SM, 5.1%, 3.4% and 2.9%, respectively (not statistically different). For ASA and SM, index hospital costs, and 30-day readmission rates had an inverse relationship to hospital volume, with statistically significant differences for both procedures between the low- and high-volume hospitals (p&amp;lt;0.05). Conclusion The annual number of SRT procedures for obstructive HCM remains low, even for higher volume hospitals. This study shows high variability in clinical events, resource utilization, and in-hospital costs by hospital procedure volume and type of SRT. We reconfirmed that higher hospital procedure volume is associated with fewer adverse clinical events and lower costs.

Out-of-pocket cost by cancer stage at diagnosis in commercially insured patients in the United States

AimsOut-of-pocket (OOP) costs may constitute a substantial financial burden to patients diagnosed with cancer. Earlier stage diagnosis and treatment of cancers may promote decreased morbidity and mortality, subsequently also lowering costs. To better understand costs experienced by patients with cancer, OOP costs by stage post-diagnosis were estimated.Materials and methodsA retrospective analysis was conducted using Optum’s de-identified Integrated Claims-Clinical dataset with Enriched Oncology, which includes data from commercially insured members (June 1, 2015–July 31, 2020). Mean annual and cumulative OOP costs (co-pay + co-insurance + deductible) (2020 USD) were reported through a 3-year period post-cancer diagnosis among adult commercially insured members (not including Medicare Advantage members) diagnosed with staged breast, cervical, colorectal, lung, ovarian, or prostate cancer between January 1, 2016 and June 30, 2020 with continuous enrollment for ≥1-month post-diagnosis.ResultsA total of 7,494 eligible members were identified who were diagnosed with breast, cervical, colorectal, lung, ovarian, or prostate cancer. A greater proportion of OOP costs were incurred in year 1 post-diagnosis but remained relatively high through year 3 post-diagnosis. Cumulative mean OOP costs were as high as $35,243 (lung stage IV) per commercially insured patient by year 3 post-diagnosis and were generally higher among those diagnosed at later stages (III/IV) than those diagnosed at earlier stages (I/II) across all cancers.LimitationsGeneralizability of these results is limited to those with commercial health insurance coverage. Additionally, cancer staging was dependent on accuracy of staging as recorded in the electronic medical record and as determined by Optum’s proprietary algorithm using natural language processing.ConclusionCumulative mean OOP costs among commercially insured patients during the 3-year period post-cancer diagnosis were substantial and generally higher among those with later stage cancer diagnoses. Diagnosis of cancer at earlier stages may allow for more timely treatment and lessen patient OOP costs.

Variation in Medicaid and commercial coverage of cell and gene therapies

Growth in the availability of cell and gene therapies (CGTs) promises significant innovation in the treatment of serious diseases, but the high cost and one-time administration of CGTs has also raised concern about strain on health plan budgets and inequity in access. We used coverage information from the Tufts Medical Center Specialty Drug Evidence and Coverage (SPEC) database for 18 large commercial health plans in the US and information from state Medicaid websites to examine variation in coverage of 11 CGTs in August 2021. We found that US commercial and Medicaid health plans imposed restrictions in 53.5 % and 68.3 % of their coverage policies for the 11 included CGTs, respectively. In addition, we identified significant variation in access to CGTs across commercial plans and across Medicaid plans. Coverage restrictions for certain CGTs were more common than others; clinical requirements were often (but not always) consistent with the inclusion criteria for the clinical trial central to the drug’s approval. We conclude that there is variation in access to CGTs, creating differential patient access.