Denial Of Coverage Research Articles

A descriptive survey of patient experiences and access to specialty medicines with alternative funding programs.

Alternative funding programs (AFPs) seek to reduce health plan sponsor costs, for example by excluding specialty drugs from a beneficiary's plan coverage and requiring patients to obtain medications through alternative sources (typically, the manufacturer's patient assistance programs) via an AFP vendor as a third-party. To describe patients' experiences and specialty medication access with AFPs. A survey method consisting of 26 optional single-choice and multiple-choice questions with branching logic divided across 5 sections (related to patient challenges with AFPs) was administered to patients recruited from an experienced AFP online patient panel and a patient advocacy group. The survey assessed patients' awareness of AFPs from their employers, experience with the patient assistance program application process via the AFP vendor, timeliness of medication access (if granted), and/or the health impact of delay in access. All descriptive and exploratory subgroup analyses were conducted by disease area and reported income levels; statistical analyses were carried out for the exploratory analyses. The final sample included 227 patients. Most patients (61% [136/223]) first heard of the AFP as part of their health benefit when trying to obtain their medication. Of 198 patients, 88% reported being stressed because of the medication coverage denial and the uncertainty of obtaining their medication. More than half of patients (54% [115/213]) reported being uncomfortable with the benefits manager from the AFP vendor. On average, patients reported waiting to receive their medication for 68.2 days (approximately 2 months); 24% (51/215) reported the wait for the medication worsened their condition and 64% (138/215) reported the wait led to stress and/or anxiety. Patients who indicated the wait time negatively affected them had considered a job change or left their job at a 3-5-fold higher rate than those who reported no impact from wait time. A significantly higher proportion of patients with hemophilia and other bleeding disorders reported receiving their prescribed medication less often than patients with other conditions (63% [19/30] vs 81% [52/64]; P = 0.022), whereas more patients with lower incomes (<$50,000 vs >$50,000) reported not receiving any medication (12% [7/57] vs 5% [7/129]; P = 0.657), although these differences were not significant. Most patients who obtain their specialty medicines via AFPs reported being uncomfortable with the process and experiencing treatment delays, which may have been linked to disease progression, worsened mental well-being, and consideration of a job change. Employers should be aware of the potential downstream impacts on employee health, retention, and the employee-employer relationship when considering implementing an AFP into their health plan.

Rationing by Inconvenience: How Insurance Denials Induce Administrative Burdens

Context: How do health coverage denials keep care out of reach for American patients by imposing unevenly distributed administrative burdens? This article argues that the process of appealing insurers’ denials imposes administrative burdens on patients inequitably, deepening the divide between those with meaningful access to health coverage and those for whom benefits are out of reach. Methods: The author conducted a nationwide survey of 1,340 US adults on their experiences with coverage denials; this was supplemented with 110 semistructured interviews with patients, physicians, and former health insurance executives. Findings: Those who were less affluent were significantly less likely than their wealthier counterparts to appeal denials of coverage. Patients who underestimated the rate at which patients prevail in insurance appeals were less likely to appeal their own denials. Black Medicaid patients and those who were in worse health were significantly less likely to prevail in the appeals they pursued. Many unappealed denials were attributable to the significant administrative burdens associated with appeal, including learning and psychological costs. Conclusions: Administrative burdens associated with appealing denials of coverage can deepen health inequities along class and race lines, suggesting a need for policy interventions to make it easier to navigate the health insurance bureaucracy.

Cross-Sectional Analysis of Exome Sequencing Diagnosis in Patients With Neurologic Phenotypes Facing Barriers to Clinical Testing.

Exome sequencing (ES) demonstrates a 20-50 percent diagnostic yield for patients with a suspected monogenic neurologic disease. Despite the proven efficacy in achieving a diagnosis for such patients, multiple barriers for obtaining exome sequencing remain. This study set out to assess the efficacy of ES in patients with primary neurologic phenotypes who were appropriate candidates for testing but had been unable to pursue clinical testing. A total of 297 patients were identified from the UCLA Clinical Neurogenomics Research Center Biobank, and ES was performed, including bioinformatic assessment of copy number variation and repeat expansions. Information regarding demographics, clinical indication for ES, and reason for not pursuing ES clinically were recorded. To assess diagnostic efficacy, variants were interpreted by a multidisciplinary team of clinicians, bioinformaticians, and genetic counselors in accordance with the American College of Medical Genetics and Genomics variant classification guidelines. We next examined the specific barriers to testing for these patients, including how frequently insurance-related barriers such as coverage denials and inadequate coverage of cost were obstacles to pursuing exome sequencing. The cohort primarily consisted of patients with sporadic conditions (n = 126, 42.4%) of adult-onset (n = 239, 80.5%). Cerebellar ataxia (n = 225, 75.8%) was the most common presenting neurologic phenotype. Our study found that in this population of mostly adult patients with primary neurologic phenotypes that were unable to pursue exome sequencing clinically, 47 (15.8%) had diagnostic results while an additional 24 patients (8.1%) had uncertain results. Of the 297 patients, 206 were initially recommended for clinical exome but 88 (42.7%) could not pursue ES because of insurance barriers, of whom 14 (15.9%) had diagnostic findings, representing 29.8% of all patients with diagnostic findings. In addition, the incorporation of bioinformatic repeat expansion testing was valuable, identifying a total of 8 pathogenic repeat expansions (17.0% of all diagnostic findings) including 3 of the common spinocerebellar ataxias and 2 patients with Huntington disease. These findings underscore the importance and value of clinical ES as a diagnostic tool for neurogenetic disease and highlight key barriers that prevent patients from receiving important clinical information with potential treatment and psychosocial implications for patients and family members.

The Implications of the Public’s Preexisting Condition—Amnesia

This JAMA Forum discusses how the Affordable Care Act (ACA) ended the denial of coverage to people with preexisting conditions and the potential ramifications if the ACA is repealed or replaced in the future.

Coverage Denials in Medicare Advantage—Balancing Access and Efficiency

This essay compares Medicare Advantage’s claim denials and reversals with traditional Medicare and questions whether coverage obligations are being met.

Coverage for evidence-based cancer survivorship care services

PurposeThe American Society of Clinical Oncology Cancer Survivorship Committee established a task force to determine which survivorship care services were being denied by public and private payers for coverage and reimbursement.MethodsA quantitative survey instrument was developed to determine the clinical practice-reported rates of coverage denials for evidence-based cancer survivorship care services. Additionally, qualitative interviews were conducted to understand whether coverage denials were based on payer policies, cost-sharing, or prior authorization.ResultsOf 122 respondents from 50 states, respondents reported that coverage denials were common (“always,” “most of the time,” or “some of the time”) for maintenance therapies, screening for new primary cancers or cancer recurrence. Respondents reported that denials in coverage for maintenance therapies were highest for immunotherapy (41.74%) and maintenance chemotherapy (40.17%). Coverage denials for new primary cancer screenings were highest for Hodgkin lymphoma survivors needing a PET/CT scan (49.04%) and breast cancer survivors at a high risk of recurrence who needed an MRI (63.46%), respectively. More than half of survey respondents reported denials for symptom management and supportive care services. Fertility services, dental services when indicated, and mental health services were denied “always” or “most of the time” 23.1%, 22.5%, and 12.8%, respectively. Respondents reported they often had a process in place to automatically appeal denials for evidence-based services. The denial process, however, resulted in greater stress for the patient and provider.ConclusionOur study demonstrates that additional advocacy with payers is needed to ensure that reimbursement policies are consistent with evidence-based survivorship care services.

Disparities in Health Insurance and the Intersection of Race/Ethnicity, Sexuality, and Gender Identity

Abstract: Status characteristics including race, sexuality, and gender identity play a significant role in people's access to health and healthcare coverage. Despite documented disadvantages across these individual statuses (e.g., race), little research has investigated how the intersection of statuses affect health coverage. Drawing on an intersectional framework, this study uses data from the 2021 Behavioral Risk Factor Surveillance System to examine the association between health insurance and the intersections of race-ethnicity, sexual orientation, and gender identity (n=206,338). This study offers three important contributions to the research literature. First, this study represents one of the first to examine the intersection of important social status characteristics and health insurance status. Second, this study examines three indicators of healthcare coverage including status (i.e., insured or not), type (i.e., public, private, employer-based, or none), and denial of coverage (i.e., insurance refused to pay for cancer treatment). Third, we investigate healthcare disparities using data representative of thirty-two states that more holistically assess people's healthcare status and allow for greater generalizability. Findings show that Hispanic straight cismen are the least likely group to have insurance. White trans adults appear to be more likely to have insurance than many other groups. Trans adults are more likely to have public insurance if they are ethnoracially marginalized. Straight Black women have high likelihoods of their insurance denying coverage. These findings highlight critical gaps in access to healthcare and myriad disadvantages in coverage. Efforts to improve population health would benefit from an intersectional lens that focuses on how multiple status characteristics shape people's access to healthcare across the life course.

Statistical analyses to determine the factors associated with early age at marriage or union among married South African women

Abstract: Status characteristics including race, sexuality, and gender identity play a significant role in people's access to health and healthcare coverage. Despite documented disadvantages across these individual statuses (e.g., race), little research has investigated how the intersection of statuses affect health coverage. Drawing on an intersectional framework, this study uses data from the 2021 Behavioral Risk Factor Surveillance System to examine the association between health insurance and the intersections of race-ethnicity, sexual orientation, and gender identity (n=206,338). This study offers three important contributions to the research literature. First, this study represents one of the first to examine the intersection of important social status characteristics and health insurance status. Second, this study examines three indicators of healthcare coverage including status (i.e., insured or not), type (i.e., public, private, employer-based, or none), and denial of coverage (i.e., insurance refused to pay for cancer treatment). Third, we investigate healthcare disparities using data representative of thirty-two states that more holistically assess people's healthcare status and allow for greater generalizability. Findings show that Hispanic straight cismen are the least likely group to have insurance. White trans adults appear to be more likely to have insurance than many other groups. Trans adults are more likely to have public insurance if they are ethnoracially marginalized. Straight Black women have high likelihoods of their insurance denying coverage. These findings highlight critical gaps in access to healthcare and myriad disadvantages in coverage. Efforts to improve population health would benefit from an intersectional lens that focuses on how multiple status characteristics shape people's access to healthcare across the life course.

Impact of Illness Severity Tools on Adolescent Psychiatric Managed Care in California.

Youth with mental illness struggle to receive essential behavioral health care. One obstacle is denial of coverage by insurance. In California, managed care consumers may apply for independent medical review (IMR) which potentially overturns an insurance denial through the California Department of Managed Healthcare (CDMHC). The authors aim to analyze IMR appeals for psychiatric treatment among adolescents and elucidate factors associated with obtaining coverage of care. We performed an analysis to identify factors that are associated with depression and substance use disorder (SUD) treatment claim denials in 11-20-year-olds from 2001 to 2022 using CDMHC data. Logistic regression modeling was used to identify specific factors related to claim characteristics and medical society instruments that are significantly associated with overturning a denial by IMR.Behavioral health IMRs are overturned at a higher rate than non-behavioral health claims. 54.5% of those with depression and 36.3% of those with SUD initially denied care coverage were overturned by IMR. For those seeking depression treatment, we found a significantly greater odds of overturn by IMR if there was a reference of CALOCUS [1.64, 95%CI (1.06-2.5)]. The odds of a SUD treatment denial being overturned was significantly greater if referencing CALOCUS [3.85 (1.54-9.62)] or ASAM [2.47, [4.3 (1.77-10.47)]. After the standardized implementation of illness severity tools in IMRs, the odds of a medically necessary claim being overturned was 2.5 times higher than before the standards.With a high percentage of claims being overturned after IMR, the findings suggest that health plans inappropriately deny medically necessary behavioral health treatment. The use of medical society instruments was associated with higher odds of overturning a denial. The recent decision of CDMHC to implement standard use of CALOCUS and similar illness severity criteria is supported by our findings and may facilitate more equitable care.

“I felt super lucky:” Luck and administrative burden in cancer-related financial hardship.

198 Background: Financial hardship after cancer diagnosis is common and leads to earlier mortality and worse quality of life. This qualitative study sought to identify causal and protective factors for financial hardship as part of a larger study to refine a theoretical model and measure of financial hardship. Methods: We recruited female breast cancer survivors at a large comprehensive cancer center. Participants completed a semi-structured interview focused on their reflections of cancer diagnosis and active treatment. Interviews assessed multiple dimensions of financial hardship (coping, impacts, worry/anxiety, depression) and contributing, protective, and contextual factors. We conducted framework qualitative analysis of interview transcripts. Results: We interviewed eighteen women with breast cancer (100% early or regional stage; 77% White; mean age 57; time since diagnosis 3-24 years). Participants reported varying levels of financial hardship during diagnosis and treatment. Financial coping behaviors ranged from minor rebudgeting, to skipping or delaying healthcare, to major decisions about family structure (e.g. having children; marriage or divorce). Even successful financial coping induced stress (“it was just really painful”) because of administrative and time burden: hypervigilance to bills and finances; waiting in phone queues; negotiating with insurance companies and employers; liaising between employer, insurance company, and care team; and learning about, gathering documents, and applying for benefits (e.g. FMLA; disability). Employment and generous health insurance were protective, but out-of-network care and coverage denials tempered this protection and introduced stress. Worry about employment or insurance loss and the administrative burdens required to financially cope also created stress. Other protective factors were largely described as good luck, such as understanding bosses, flexible work arrangements, multiple household incomes, assistance from family and friends, or avoidance of more severe hardship (“we were fortunate we didn't lose our home"). Easily accessible health insurance was also described as good luck. Conclusions: Administrative and time burden required for financial coping behaviors can induce distress for women with breast cancer, even if successful in mitigating financial hardship. Luck emerged as a prominent protective factor. Luck and its relationship to structural factors that generate inequity may have ethical and policy implications for addressing cancer-related financial hardship and is worthy of further study.

INCONVERTIBILITY LOSS AND MURABAHA: A RECOVERY OPTION FOR ISLAMIC POLITICAL RISK INSURERS

This paper attempts to illustrate the primacy of the Shari’a-compliant murabaha transaction as a means of inconvertibility loss recovery by Islamic political risk insurers. In practical terms, the risk most likely to occur in an underdeveloped Muslim country is the risk of the local currency becoming inconvertible because of a certain action or inaction by the authorities of the host country which is the destination of an export trade transaction, or a foreign direct investment covered under a political risk insurance policy. The political risk insurance (PRI) operator most concerned with the subject of this paper is the Islamic Corporation for the Insurance of Investment and Export Credit (ICIEC), a member of the Islamic Development Bank (IsDB) Group. Where the PRI operator is established within the auspices of a lending agency which lends in local currency, and provided that the necessary legal arrangements are in place, the PRI’s local currency holdings could be passed on to the lending agency in the host country and the foreign currency equivalent thereof paid over to the PRI operator at its head office. In countries where a lender is not extending local currency financing and a speedy economic recovery is not expected, an attractive alternative for a PRI operator, as the authors argue, is the utilization of the local currency in murabaha transactions. PRI operators’ apprehension about the risk of inconvertibility finds expression in denial of the inconvertibility coverage altogether. Where this is not the case, a PRI operator may impose recovery ceilings, demand the expiry of extended waiting periods, as well as compliance with a variety of other conditions prior to recovery. This paper argues that such measures are self-defeating. A Shari’a-compliant PRI operator is necessarily established to provide coverage against commercial and non-commercial risks in poor Muslim countries. To deny or restrict inconvertibility risk coverage in such countries is unacceptable. Murabaha is a panacea for currency inconvertibility: it is the most popular form of Islamic financing in the world, it is easy to structure, and its profits are almost certainly rewarding. While the risk of non-payment of the price by overseas buyers of Muslim country exports is minimal, risks associated with murabahacould be further minimized by means of export credit insurance coverage by local export promotion agencies.

Beyond Being Insured: Insurance Coverage Denial as a Major Barrier to Accessing Care During Pregnancy and Postpartum.

This study investigates the association between insurance coverage denial and delays in care during pregnancy and postpartum. An online survey was administered in March and April 2022 to women who were either pregnant or within 1 year postpartum (n = 1,113). The outcome was delayed care, measured at four time points: during pregnancy and 1 week, 2 to 6 weeks, and after 7 weeks postpartum. The key covariate was insurance coverage denial by providers during pregnancy. Delayed care due to having an unaccepted insurance and being "out-of-network" was more pronounced at 1 week postpartum with 3.37 times and 3.47 times greater odds and in 2 to 6 weeks postpartum with 5.74 times and 2.97 times greater odds, respectively. The association between insurance denial and delays in care encapsulated transportation, rural residency, time issues, and financial constraints. The findings suggest that coverage denial is associated with significant delays in care, providing practical implications for effective perinatal care.

D46. US Insurance Coverage of Lymphatic Microsurgical Preventing Healing Approach: A Critical Review

PURPOSE: Breast-cancer-related lymphedema (BCRL) is a chronic, debilitating condition that is associated with patients who have undergone axillary lymph node dissection (ALND). Recently, Lymphatic Microsurgical Healing Approach (LYMPHA), a prophylactic microsurgical lymphovenous bypass technique, has been developed to prevent BCRL with promising results. However, insurance coverage is often denied. We investigated current coverage policies for LYMPHA among the top insurance providers in the United States. METHODS: Insurers were selected by identifying 50 companies with the largest market share and cross-referencing them with companies with greatest enrollment per state. Cross-sectional evaluation was performed on publicly available LYMPHA policies through a web-based search or phone call. Coverage status, coverage criteria, and exclusion rationale were collected and analyzed using descriptive statistics. RESULTS: Of the 63 insurers queried, 42.9% (n=27) do not have any public policies regarding LYMPHA coverage. Of those that do have a coverage policy (57.1%; n=36), 75.0% (n=27) deny coverage and 25.0% review claims on a case-by-case basis. In 21 of the coverage denials, LYMPHA was considered investigational, not standard practice, or to have insufficient published evidence. CONCLUSION: LYMPHA is known to significantly decrease the rates of BCRL following mastectomy and ALND, yet over half of the major insurance providers in the United States currently deny coverage. Focus should shift towards sharing high-level evidence at the legislative level to increase insurance coverage and therefore access to lymphedema prevention for breast cancer patients.

315 A patient survey to identify atopic dermatitis prescription treatment access barriers

Abstract Atopic dermatitis (AD) is the most prevalent form of eczema and is a chronic disease with a relapsing-remitting nature. Multiple treatment options exist, yet little is known about patients’ ability to obtain recommended prescription treatments. The aim of this web-based survey was to ascertain the frequency, causes and patient impact of insurance delays and denials for AD prescription treatments. Adult AD patients (18 + years) or caregivers of pediatric AD patients were recruited to complete a survey about experiences with prescription treatment access in the last 12 months. Responses from 1234 AD patients (42.0 ± 16.7 years) and 248 caregivers (8.5 ± 4.7 years) were included in the analysis; 55.4% (n = 680) reported moderate or severe AD. Overall, there were 789 insurance delays or denials for AD prescriptions, with 37.0% (457/1234) of respondents experiencing at least one in the past 12 months. Overall, the majority of delays/denials were for topical steroids (38.3%; 302/789), which is likely due to the high number of patients using one or more topical steroid prescriptions (82.5%; 1018/1234). However, the highest individual drug class burden was on biologics, for which 38.7% of all prescriptions (122/315) faced a delay or denial. Coverage denials were caused primarily by step therapy (25.5%), and delays by prior authorization (61.1%), and only 62.0% of respondents said they would know what to do if they faced an issue getting a prescription covered by their insurer. Patient-reported impacts of prescription denials and delays included: AD flares (85.0%; n = 255), needing alternate medications (72.3%; n = 217), emergency care (49.0%; n = 147) and giving up on treatment altogether (59.0%; n = 177). Patients with AD and their families frequently experience issues obtaining recommended therapies which can result in detrimental health and quality of life impacts. As many as one-third of patients may not know how to respond if their prescriptions are met with insurance delays or denials, further exacerbating those impacts. These data may help identify strategies to improve timely and beneficial therapeutic access.

Ropegiterferon Alfa-2b-Njft for Treatment Myeloproliferative Neoplasms: A Single Institution Experience

Background: While interferon alfa has been used for decades as a cytoreductive agent in myeloproliferative neoplasms (MPNs), tolerability and need for frequent parenteral administration have limited its widespread adoption. Ropeginterferon Alfa-2b-njft (ropeg) is monopegylated extended half-life interferon alpha product that received FDA approval for treatment of polycythemia vera (PV) in November 2021. A phase III clinical trial has demonstrated efficacy and tolerability of this novel agent as compared to hydroxyurea (HU) in PV patients with indication for cytoreductive therapy. Real-world experience (RWE) assessment of a newly available pharmaceutical can yield important insights regarding barriers to access, clinical feasibility, and usage in populations not yet evaluated in clinical trial. In this single institution cohort, we report the first RWE using ropeg for patients with MPNs, including essential thrombocythemia (ET), in the United States. Methods: Patients presenting to an MPN clinic at an academic medical center were evaluated for initiation of ropeg based individualized assessment, with patients engaged in shared decision-making regarding risks and benefits. Patients were screened for autoimmune, neuropsychiatric, or endocrine disorder on basis of history and limited laboratory investigation as appropriate, including thyroid stimulating hormone, triglycerides, and anti-nuclear antibody testing. The treating physician and pharmacist provided pre-treatment counseling including review of potential toxicities, administration teaching, and financial considerations. Patients on HU were started on a dose 50mcg every 2 weeks via subcutaneous injection with subsequent HU tapering; patients not on HU were started 100mcg every 2 weeks. Ropeg dosing was increased to target hematologic response. Complete blood counts and comprehensive metabolic panels were ordered every 2 weeks until hematologic response achieved, with less frequent monitoring thereafter. Results: Between December 2021 to June 2022, 13 patients with JAK2 V617F positive MPNs have been started on ropeg. Four patients were unable to start ropeg due to payor denial of coverage and ineligibility for manufacturer patient assistance programs. Patients were predominantly female (10/13, 77%) with average age of 60.9 years (range 36-73 years). Seven patients had PV (transformed from ET in 2 cases), 5 patients had ET, and 1 patient had post-ET myelofibrosis. Mean pre-treatment hematocrit, platelet count, and WBC were 42.5% (range 34.3% - 51.5%), 630 *109/L (range 127-2065*109/L), and 7.0*109/L (range 2.5 - 13*109/L) respectively. At treatment start, 7 patients were on HU (either alone or in combination with therapeutic phlebotomy (TP)), 1 was on TP alone, 1 was on ruxolitinib, 1 was on peginterferon alfa-2a, and 3 were on no cytoreductive treatment. Reasons for switching to ropeg included poor tolerance or efficacy of prior therapy (6/13, 46%), patient interest in potential disease modifying properties of interferon (6/13, 46%), and, in the case of patient on peginterferon alfa-2a, ease of administration (1/13, 7.6%). Patients received medication through insurance approval with copay assistance (11/13, 85%) or through the manufacturer patient assistance program (2/13, 15%). Average time to receipt of medication from prescription submission was 25 days. At mean follow-up time of 12.9 weeks, all patients remain on treatment. One patient required treatment interruption due to severe fatigue, two patients deferred scheduled doses due to cold-like symptoms. While efficacy data is immature, one patient with PV and 2 patients with ET obtained a hematologic response (hematocrit <45% without phlebotomy in 3 months and platelet count <450), with mean response time 6.9 weeks (range 5.7 -7.7). Two patients experienced rebound in hematocrit after HU stop and are requiring TP as bridging therapy. Conclusions: Medication access, patient counseling, and symptom and laboratory monitoring must be addressed in translating clinical trial findings to clinical practice with ongoing evaluation of drug efficacy and safety. In a single institution analysis, 13 patients with MPNs, including 5 patients with ET, were started on ropeg with good initial tolerance at mean follow-up of 12.9 weeks. Lengthy insurance approval process and payor coverage denials limit medication access.

Health care disparities in surgical treatment of rotator cuff disease.

Health care disparities have been well-documented in literature to affect care and recovery after surgery. Insurance type is regularly cited by orthopedic surgeons to play a role in the incongruences faced by patients in the perioperative period. Recent trends highlight an increased reluctance by some insurance companies to approve indicated surgery. Our primary objective was to assess insurance type and how it affects approval rates for rotator cuff débridement and rotator cuff repair. A retrospective review of 999 patients who underwent arthroscopic rotator cuff débridement or repair was conducted. Data abstraction included demographics, prior surgical or nonsurgical interventions, radiologic imaging, insurance type, and denial of insurance coverage. Patients were grouped by insurance type-Medicaid, Medicare, workers' compensation, and private insurance. Univariable and multivariable logistic regression models were developed to estimate odds ratios (ORs) for insurance type associated with the denial of insurance coverage. Nine hundred ninety-seven patients were included in our final analysis. Those with private insurance were more likely to be non-Hispanic white (71%), whereas the proportion of Hispanics was highest among those with workers' compensation (27%) and Medicaid (20%). There were no significant differences by insurance type for prior nonsurgical interventions and radiologic imaging. For previous surgical interventions (13%), however, rates were higher for Medicaid (18%) and workers' compensation (17%) than those for Medicare (12%) and private insurance (9%) (P=.003). Compared with private insurance, the odds of insurance denial were significantly higher for those with Medicaid at 54% (OR: 7.91, 95% confidence interval: 5.27-11.88, P<.001) and workers' compensation at 19% (OR: 1.71, 95% confidence interval: 1.04-2.81, P=.04). One in 2 patients with Medicaid coverage faces insurance denial compared with any other insurance type. Workers' compensation follows with the second highest rates. Almost half the Hispanic population are insured by either Medicaid or workers' compensation and may face barriers to care that can negatively impact outcomes and complication rates.

Enrollment Lessons from a Biological Assignment Study of Marrow Transplantation versus Standard Care for Adolescents and Young Adults with Sickle Cell Disease: Considerations for Future Gene and Cellular Therapy Trials

We previously conducted a single-arm feasibility study (STRIDE1) of myeloablative bone marrow transplantation (BMT) in adolescents and young adults with sickle cell disease (SCD). The trial identified donors before entry, enrolled well, and found no unexpected regimen-related toxicity. Although many single-arm studies have been published, there are no controlled trials of either BMT or gene therapy in SCD. Therefore, we designed a comparative trial by biological assignment (available donor versus no donor). This multicenter National Institutes of Health-funded study (Blood and Marrow Transplant Clinical Trials Network 1503; STRIDE2) enrolled patients between 2016 and 2021 at 35 sites. Lagging recruitment led to study closure, and here we report the impediments to accrual. The BMT regimen and entry criteria were from STRIDE1, and 2-year survival was the primary endpoint. To minimize selection bias from prior HLA typing, STRIDE2 excluded individuals with previously identified donors. Accrual was stopped at 69% of target (138 enrolled; assigned 28 with donor, 96 with no donor). Barriers to enrollment included lower than expected frequency of HLA-matched related and unrelated donors; loss of enrollees owing to previously identified donors; conventional care arm dissuading some seeking BMT; challenging short-term endpoints in SCD, including incomplete documentation of sickle pain episodes; state Medicaid (primary insurers of SCD) denial of BMT coverage for adult SCD despite the study having secured Coverage with Evidence Development from the Center for Medicare & Medicaid Services; slowed accrual in 2019 to 2021 during the Coronavirus disease 2019 pandemic; and restriction of BMT resourcing for nonmalignant diseases by academic medical (cancer) centers. Social obstacles and access to BMT centers also limited entry, as did practitioner and participant concerns over suitability, cost, and toxicity. Planning for future controlled trials of curative therapy in SCD and other nonmalignant diseases likely will meet these enrollment challenges. Lessons from this trial may aid the development of future comparative studies.

A pilot intervention to improve health insurance literacy and financial toxicity among recently diagnosed adolescents and young adults with cancer.

218 Background: Adolescents and young adults (AYAs; ages 18-39) with cancer report worries about costs and feeling uninformed about their insurance, which may impair their ability to navigate the health care system, use their insurance, and manage costs. We conducted a pilot randomized controlled trial (RCT) to assess a virtually delivered health insurance navigation intervention (“CHAT”) to improve health insurance literacy (HIL) and knowledge, increase awareness of insurance protections in the Affordable Care Act (ACA), and reduce financial toxicity and stress. Methods: CHAT is a 4-session program delivered by a patient navigator. Session content included learning about insurance, navigating your plan, insurance-related laws, &amp; managing care costs. Eligible participants had access to a wireless device, were within their first year of cancer diagnosis, and were treated at oncology sites from the University of Utah Healthcare and Intermountain Healthcare systems. We assessed feasibility and preliminary efficacy of CHAT compared to usual navigation care, including HIL (9 items on confidence using insurance), insurance knowledge (13 items on terms such as deductible &amp; copay), ACA protections (8 items), Perceived Stress Scale (PSS; 4 items), and COmprehensive Score for financial Toxicity (COST; 11 items) using t-tests. Results: From November 2020 to January 2022, 86 AYAs enrolled (46.2% approached consented); 68.6% were female, 72.1% white, 18.6% Hispanic, 34.9% age 18-25, 65.1% age 26-39, 83.7% had private insurance, and 10.5% public. Mean baseline HIL scores were 22.6 (range = 9-33, SD = 5.5). At baseline, 65.1% of participants were unaware of the ACA provision allowing appeals for coverage denials. 64.4% of intervention participants completed all 4 sessions; 86.0% completed the 5-month follow-up survey with data collection ongoing (74/86). At follow-up, compared to usual navigation care, CHAT participants had improvements in HIL, knowledge of insurance, and knowledge of ACA provisions (Table). While PSS improved more for CHAT than usual care, COST did not differ. Conclusions: Results support the feasibility and preliminary efficacy of CHAT with related improvements in HIL and knowledge of the ACA. Clinical trial information: NCT04448678. [Table: see text]

Cancer health disparities in the state of Georgia: African American oncology care.

1546 Background: Approximately 58,970 new cancer diagnoses are projected for 2022 in Georgia (GA), contributing to 18,750 deaths. African Americans (AA) make up about one-third of Georgia’s population compared to 14% of the national population. Cancer survival rates are lower for AA than non-AA for almost all cancer types. Biological factors do not account for all these differences. We explore the impact of racial disparities on cancer care in Georgia. Methods: We used 2020 behavioral risk factor surveillance system (BRFSS) data to capture patient-reported data on various demographic and health coverage variables. Oncology patients in the stage of Georgia were selected for our analysis. We evaluated the effect of racial disparities on clinical services received. Results: In the state of GA, 9,090 participants responded to the 2020-BRFSS, of which 400 partcipants had a history of cancer diagnosis other than skin cancer. Males and females comprised 37% and 63%, respectively. AA represented 15.8% of the respondents. The majority of the oncology respondents reported having health care coverage (96%) and having insurance coverage for all cancer treatments (96.8%) despite having 81.9% of the participants unemployed. Compared to non-AA, AA participants reported lower rates of health insurance payment for cancer treatment (84% v 99.3%, P = 0.0022) and lower levels of annual incomes (percentage of annual income &lt;50,000$/year was 72.3% vs 51.5%, P = 0.0151). AA participants were four times less likely to have full coverage for cancer-related treatment than non-AA (odds ratio=4.31). There was no statistically significant difference in secondary education rates, health care coverage, the inability to see a physician due to cost, receipt of summary of treatment or written instructions, denial of insurance coverage due to cancer, and clinical trial participation. Participants with at least secondary education were more likely to have full insurance coverage for all cancer treatment expenses (P = 0.0206). Conclusions: Among cancer patients in Georgia, income rates were lower in AA than in non-AA. They were also less likely to have full coverage for cancer-related treatment. Analysis suggests secondary education increases the likelihood of having full insurance coverage. Education and income disparity may have a bearing on the accessibility and quality of cancer care. Addressing these inequities on a societal level will be key in ensuring high-quality oncology care for all. [Table: see text]

A health insurance navigation intervention tool (HINT) for survivors of childhood cancer: Randomized pilot trial results from the Childhood Cancer Survivor Study.

6508 Background: Childhood cancer survivors are vulnerable to being underinsured and health insurance-related financial burden. Low health insurance literacy reduces survivors’ ability to utilize health insurance. We conducted a pilot randomized controlled trial (RCT) to assess a virtually delivered health insurance navigation tool (HINT) intervention to improve health insurance literacy (HIL) and decrease financial burden. Methods: Using a multiphase, mixed methods design, we developed and tested a theoretically-driven 4-session intervention that included: 1) Learning About Survivorship Healthcare Needs, 2) Learning About Your Plan in Relation to Policy, 3) Navigating Your Plan and Obstacles, and 4) Managing Care Costs. Eligible CCSS participants were insured and had wireless device access. We assessed feasibility and preliminary efficacy of HINT versus enhanced usual care (EUC; health insurance booklet) on HIL (16-item instrument assessing knowledge and confidence with health insurance terms and activity, ACA provisions knowledge (8-items), psychological financial burden (7-items assessing worry due to medical costs), and satisfaction with health insurance coverage (1 item) using multivariable linear regression. Results: From 8/20 to 5/2021, 82 participants enrolled (39.7% participation rate); 53.7% female; 82% white, 7% Hispanic, and 7% black; 52.4% &lt;40 years of age; and 57.3% from a Medicaid expansion state. 25.6% reported previously being uninsured. 57.3% were diagnosed &lt;10 years of age, and 40.1% had ≥1 severe chronic health condition. There were gaps in health insurance literacy (HIL mean 28.5, sd=9.0; 16-60 (high-low); 39.0% were not familiar with the Affordable Care Act (ACA), and many lacked ACA provisions knowledge (e.g., appeals for coverage denials (56.1%). 82% completed 4 sessions; 92.6% completed the 5-month follow-up survey. Compared to EUC, HINT significantly improved HIL, ACA provisions knowledge, psychological financial hardship, and health insurance satisfaction (p’s ≤ 0.03). Conclusions: Findings affirm health insurance literacy gaps among a national sample of insured long-term survivors. Results support the feasibility and preliminary efficacy of HINT on improving health insurance literacy, satisfaction, and psychological financial burden. HINT is the first intervention to demonstrate improvements in long-term survivors’ health insurance literacy and psychological financial burden. Clinical trial information: NCT04520061. [Table: see text]