Out-of-pocket costs for diagnostic testing following abnormal prostate cancer screening among privately insured men.

OBJECTIVE: Prostate cancer is the most common malignancy among men and following a positive prostate-specific antigen (PSA) screening test, patients may undergo more expensive diagnostic testing. However, testing-related out-of-pocket costs (OOPCs), which may preclude patients from completing the screening process, have not been previously quantified. OOPCs for follow-up diagnostic testing (i.e., prostate biopsy and/or magnetic resonance imaging [MRI]) in patients with private insurance undergoing prostate cancer screening were estimated. METHODS: Men ages 55 to 69 years old who underwent PSA-based prostate cancer screening from 2010 to 2020 from the IBM Marketscan database were identified. The number of patients undergoing follow-up diagnostic testing within 12 months of screening was tabulated, dividing patients into three groups: (1) biopsy only, (2) MRI only, and (3) MRI + biopsy. Over the study period, patients with nonzero cost-sharing and calculated inflation-adjusted OOPCs, adding copayment, coinsurance, and deductible payments, for each group were identified. RESULTS: Among screened patients (n = 3,075,841) from 2010 through 2020, 91,850 had a second PSA test and an elevated PSA level, of which 40,329 (43.9%) underwent subsequent diagnostic testing. More than 75% of these patients experienced cost-sharing, and median OOPCs rose substantially over the study period for patients undergoing biopsy only ($79 to $214), MRI only ($81 to $490), and MRI and biopsy ($353 to $620). CONCLUSIONS: OOPCs from diagnostic testing after prostate cancer screening are common and rising. This work aligns with the recent position statement from the American Cancer Society, that payers should eliminate cost-sharing, which may undermine the screening process, for diagnostic testing following cancer screening.

Availability and Cost of Expensive and Common Generic Prescription Drugs: A Cross-sectional Analysis of Direct-to-Consumer Pharmacies.

BACKGROUND: Direct-to-consumer (DTC) pharmacies sell generic prescription drugs, often at lower prices than traditional retail pharmacies; however, not all drugs are available, and prices vary. OBJECTIVE: To determine the availability and cost of generic drugs at DTC pharmacies. DESIGN: Cross-sectional study. SETTING: Five national DTC pharmacies in April and May 2023. PARTICIPANTS: Each qualifying form of 100 generic drugs with the highest cost-per-patient (expensive) and the 50 generic drugs with the highest number of patients (common) in Medicare Part D in 2020 MAIN MEASURES: Availability of these drugs and the lowest DTC pharmacy price for a standardized drug strength and supply (e.g., 30 pills), compared to GoodRx retail pharmacy prices. KEY RESULTS: Of the 118 expensive generic dosage forms, 94 (80%) were available at 1 or more DTC pharmacies; out of 52 common generic dosage forms, 51 (98%) were available (p < 0.001). Of the 88 expensive generics available in comparable quantities and strengths across pharmacies, 42 (47%) had the lowest cost at Amazon, 23 (26%) at Mark Cuban Cost Plus Drug Company, 13 (14%) at Health Warehouse, and 12 (13%) at Costco; for 51 common generic formulations, 16 (31%) had the lowest cost at Costco, 14 (27%) at Amazon, 10 (20%) at Walmart, 6 (12%) at Health Warehouse, and 5 (10%) at Mark Cuban Cost Plus Drug Company. For the 77 expensive generics with available GoodRx retail pharmacy prices, the median cost savings at DTC pharmacies were $231 (95% CI, $129-$792) or 76% (IQR, 53-91%); for 51 common generics, savings were $19 (95% CI, $10-$34) or 75% (IQR, 67-83%). CONCLUSIONS: Many of the most expensive generic drugs are unavailable at direct-to-consumer pharmacies. Meanwhile, less expensive, commonly used generics are widely available, but drug prices vary by pharmacy and savings are modest, requiring patients to shop around for the lowest cost.

The out-of-pocket expenses of people with tinnitus in Europe.

BACKGROUND: Despite the high frequency of tinnitus and its impact on wellbeing, little is known about its economic burden and no data to our knowledge are available on out-of-pocket (OOP) expenses. METHODS: In 2022 a survey was conducted on OOP costs of tinnitus. We enrolled 679 participants with slight, moderate and severe tinnitus in Italy, United Kingdom, Netherlands, Germany and Spain. We estimated annual OOP expenses for tinnitus-related healthcare visits, treatments, medications and alternative medicine practices. Prevalence of tinnitus in the general population, obtained from a representative survey we conducted in Europe in 2017-2018, was used to generalise costs for people with any tinnitus at the national level. RESULTS: OOP expenses were 368€ (95% confidence intervals (CI), 78€-690€), 728€ (95% CI, 316€-1,288€), and 1,492€ (95% CI, 760€-2,688€) for slight, moderate, and severe tinnitus, respectively, with annual expenditure of 565€ for people with any tinnitus: 209€ for healthcare visits, 93€ for treatments, 16€ for drugs, 64€ for hearing supporting systems and 183€ for acupuncture, homeopathy and osteopathy. Individuals with slight, moderate, and severe tinnitus expressed a willingness to invest 1.6, 4.3, and 7.0 times their monthly income, respectively, to achieve complete relief from tinnitus. CONCLUSIONS: This study offers for the first time insights into the OOP expenses incurred by individuals with tinnitus. OOP expenses exhibited substantial variations based on severity status, accounting for more than 17 thousand million€ in the countries considered. In terms of financial burden, these findings align tinnitus to the recognised leading disabilities, including back pain and migraine.

Trends in Costs and Professional Reimbursements for Revision Total Hip and Knee Arthroplasty.

BACKGROUND: With increasing numbers of revision total hip and total knee arthroplasties (rTHAs and rTKAs), understanding trends in related out-of-pocket (OOP) costs, overall costs, and provider reimbursements is critical to improve patient access to care. METHODS: A large database was used to identify 92,116 patients who underwent rTHA or rTKA between 2009 and 2018. The OOP costs associated with the surgery and related inpatient care were calculated as the sum of copayment, coinsurance, and deductible payments. Professional reimbursement was calculated as total payments to the principal physician. All monetary data were adjusted to 2018 dollars. Multivariate regressions evaluated the associations between costs and procedure type, insurance type, and region of service. RESULTS: From 2009 to 2018, overall costs for rTHA significantly increased by 35.0% and overall costs for rTKA significantly increased by 32.3%. The OOP costs for rTHA had no significant changes, while OOP costs for rTKA increased by 20.1%, with patients on Medicare plans having the lowest OOP costs. Professional reimbursements, when measured as a percentage of overall costs, decreased significantly by 4.4% for rTHA and 4.0% for rTKA, with the lowest reimbursements from Medicare plans. CONCLUSION: From 2009 to 2018, total costs related to rTHA and rTKA significantly increased. The OOP costs significantly increased for rTKA, and professional reimbursements for both rTHA and rTKA decreased relative to total costs. Overall, these trends may combine to create greater financial burden to patients and the healthcare system, as well as further limit patients' access to revision arthroplasty care.

Comparison of the out-of-pocket costs of Medicare-funded telepsychiatry and face-to-face consultations: A descriptive study.

OBJECTIVE: Telepsychiatry items in the Australian Medicare Benefits Schedule (MBS) were expanded following the COVID-19 pandemic. However, their out-of-pocket costs have not been examined. We describe and compare patient out-of-pocket payments for face-to-face and telepsychiatry (videoconferencing and telephone) MBS items for outpatient psychiatric services to understand the differential out-of-pocket cost burden for patients across these modalities. METHODS: out-of-pocket cost information was obtained from the Medical Costs Finder website, which extracted data from Services Australia's Medicare claims data in 2021-2022. Cost information for corresponding face-to-face, video, and telephone MBS items for outpatient psychiatric services was compared, including (1) Median specialist fees; (2) Median out-of-pocket payments; (3) Medicare reimbursement amounts; and (4) Proportions of patients subject to out-of-pocket fees. RESULTS: Medicare reimbursements are identical for all comparable face-to-face and telepsychiatry items. Specialist fees for comparable items varied across face-to-face to telehealth options, with resulting differences in out-of-pocket costs. For video items, higher proportions of patients were not bulk-billed, with greater out-of-pocket costs than face-to-face items. However, the opposite was true for telephone items compared with face-to-face items. CONCLUSIONS: Initial cost analyses of MBS telepsychiatry items indicate that telephone consultations incur the lowest out-of-pocket costs, followed by face-to-face and video consultations.

Public drug insurance, moral hazard and children's use of mental health medication: Latent mental health risk-specific responses to lower out-of-pocket treatment costs.

Studies have shown that reducing out-of-pocket costs can lead to higher medication initiation rates in childhood. Whether the cost of such initiatives is inflated by moral hazard issues remains a question of concern. This paper looks to the implementation of a public drug insurance program in Québec, Canada, to investigate potential low-benefit consumption in children. Using a nationally representative longitudinal sample, we harness machine learning techniques to predict a child's risk of developing a mental health disorder. Using difference-in-differences analyses, we then assess the impact of the drug program on children's mental health medication uptake across the distribution of predicted mental health risk. Beyond showing that eliminating out-of-pocket costs led to a 3 percentage point increase in mental health drug uptake, we show that demand responses are concentrated in the top two deciles of risk for developing mental health disorders. These higher-risk children increase take-up of mental health drugs by 7-8 percentage points. We find even stronger effects for stimulants (8-11 percentage point increases among the highest risk children). Our results suggest that reductions in out-of-pocket costs could achieve better uptake of mental health medications, without inducing substantial low-benefit care among lower-risk children.

Financial toxicity experienced by rural Australian families with chronic kidney disease.

AIM: Chronic kidney disease (CKD) and its treatment places a financial burden on healthcare systems and households worldwide, yet little is known of its financial impact, on those who reside in rural settings. We aimed to quantify the financial impacts and out-of-pocket expenditure experienced by adult rural patients with CKD in Australia. METHODS: A web based structured survey was completed between November 2020 and January 2021. English speaking participants over 18 years of age, diagnosed with CKD stages 3-5, those receiving dialysis or with a kidney transplant, who lived in a rural location in Australia. RESULTS: In total 77 (69% completion rate) participated. The mean out of pocket expenses were 5056 AUD annually (excluding private health insurance costs), 78% of households experienced financial hardship with 54% classified as experiencing financial catastrophe (out-of-pocket expenditure greater than 10% of household income). Mean distances to access health services for all rural and remote classifications was greater than 50 kilometres for specialist nephrology services and greater than 300 kilometres for transplanting centres. Relocation for a period greater than 3 months to access care was experienced by 24% of participants. CONCLUSION: Rural households experience considerable financial hardship due to out-of-pocket costs in accessing treatment for CKD and other health-related care, raising concerns about equity in Australia, a high-income country with universal healthcare.

Is there an association between out-of-pocket hospital costs, quality and care outcomes? A systematic review of contemporary evidence.

BACKGROUND: Out of pocket (OOP) costs vary substantially by health condition, procedure, provider, and service location. Evidence of whether this variation is associated with indicators of healthcare quality and/or health outcomes is lacking. METHODS: The current review aimed to explore whether higher OOP costs translate into better healthcare quality and outcomes for patients in inpatient settings. The review also aimed to identify the population and contextual-level determinants of inpatient out-of-pocket costs. A systematic electronic search of five databases: Scopus, Medline, Psych Info, CINAHL and Embase was conducted between January 2000 to October 2022. Study procedures and reporting complied with PRISMA guidelines. The protocol is available at PROSPERO (CRD42022320763). FINDINGS: A total of nine studies were included in the final review. A variety of quality and health outcomes were examined in the included studies across a range of patient groups and specialities. The scant evidence available and substantial heterogeneity created challenges in establishing the nature of association between OOP costs and healthcare quality and outcomes. Nonetheless, the most consistent finding was no significant association between OOP cost and inpatient quality of care and outcomes. INTERPRETATION: The review findings overall suggest no beneficial effect of higher OOP costs on inpatient quality of care and health outcomes. Further work is needed to elucidate the determinants of OOP hospital costs. FUNDING: This study was funded by Medibank Better Health Foundation.

The Inflation Reduction Act: How Will Medicare Negotiating Drug Prices Impact Patients with Heart Disease?

PURPOSE OF REVIEW: Cardiovascular medications improve health and prevent early death. However, high drug prices reduce the use of these medications and strain the health system. The Inflation Reduction Act (IRA) of 2022 allows Medicare to negotiate drug prices with manufacturers and reduces out-of-pocket drug costs for Medicare beneficiaries. This article explores the potential impact that the IRA will have on the treatment of cardiovascular disease. RECENT FINDINGS: Cardiovascular disease medications are likely to be selected for price negotiations under the IRA, leading to savings for patients and for Medicare. Recent work suggests that the IRA's reforms to the Medicare Part D drug benefit will meaningfully reduce out-of-pocket costs for important cardiovascular medications. The IRA is expected to impact cardiovascular disease treatments via price negotiations and through the broader access to medications afforded by improvements to Part D coverage design.

Fintech and medical expenses: What social workers should know.

Individuals who cannot afford out of pocket medical expenses may reduce health care use, resulting in poorer health outcomes. To ease the situation, employers turn to financial technology ("fintech") health care credit applications. We examine whether an employer-sponsored credit fintech application (MedPut) helps employees manage medical expenses. Results of the analysis of variance (ANOVA) and probit regression models reveal MedPut users did worse financially and delayed health care due to cost more often than employees who did not use MedPut. Results may inform social work policy and direct practice perspectives on fin-tech and medical expenses.

Perceived financial decline related to breast reconstruction following mastectomy in a diverse population-based cohort.

BACKGROUND: Despite mandated insurance coverage for breast reconstruction following mastectomy, health care costs are increasingly passed on to women through cost-sharing arrangements and high-deductible health plans. In this population-based study, the authors assessed perceived financial and employment declines related to breast reconstruction following mastectomy. METHODS: Women with early-stage breast cancer (stages 0-II) diagnosed between July 2013 and May 2015 who underwent mastectomy were identified through the Surveillance, Epidemiology, and End Results registries of Georgia and Los Angeles and were surveyed. Primary outcome measures included patients' appraisal of their financial and employment status after cancer treatment. Multivariable models evaluated the association between breast reconstruction and primary outcomes. RESULTS: Among 883 patients with breast cancer who underwent mastectomy, 44.2% did not undergo breast reconstruction, and 55.8% underwent reconstruction. Overall, 21.9% of the cohort reported being worse off financially since their diagnosis (25.8% with reconstruction vs 16.6% without reconstruction; P = .002). Women who underwent reconstruction reported higher out-of-pocket medical expenses (32.1% vs 15.6% with expenses greater than $5000; P < .001). Reconstruction was independently associated with a perceived decline in financial status (odds ratio, 1.92; 95% confidence interval, 1.15-3.22; P = .013). Among women who were employed at the time of their diagnosis, there was no association between reconstruction and a perceived decline in employment status (P = .927). CONCLUSIONS: In this diverse cohort of women who underwent mastectomy, those who elected to undergo reconstruction experienced higher out-of-pocket medical expenses and self-reported financial decline. Patients, providers, and policymakers should be aware of the potential financial implications related to reconstruction despite mandatory insurance coverage.

Subjective Financial Hardship due to Medical Bills Among Patients With Heart Failure in the United States: The 2014-2018 Medical Expenditure Panel Survey.

BACKGROUND: Heart failure (HF) poses a substantial economic burden on the United States (US) health care system. In contrast, little is known about the financial challenges faced by patients with HF. In this study, we examined the scope and sociodemographic predictors of subjective financial hardship due to medical bills incurred by patients with HF. METHODS: In the Medical Expenditure Panel Survey (MEPS; years 2014--2018), a US nationally representative database, we identified all patients who reported having HF. Any subjective financial hardship due to medical bills was assessed based on patients' reporting either themselves or their families (1) having difficulties paying medical bills in the past 12 months, (2) paying bills late or (3) being unable to pay bills at all. Logistic regression was used to evaluate independent predictors of financial hardship among patients with HF. All analyses took into consideration the survey's complex design. RESULTS: A total of 116,563 MEPS participants were included in the analysis, of whom 858 (0.7%) had diagnoses of HF, representing 1.8 million (95% CI 1.6-2.0) patients annually. Overall, 33% (95% CI 29%-38%) reported any financial hardship due to medical bills, and 13.2% were not able to pay bills at all. Age ≤ 65 years and lower educational attainment were independently associated with higher odds of subjective financial hardship due to medical bills. CONCLUSION: Subjective financial hardship is a prevalent issue for patients with HF in the US, particularly those who are younger and have lower educational attainment. There is a need for policies that reduce out-of-pocket costs for the care of HF, an enhanced identification of this phenomenon in the clinical setting, and approaches to help minimize financial toxicity in patients with HF while ensuring optimal quality of care.

Out-of-network bills among privately insured patients undergoing hysterectomy.

BACKGROUND: In recent years, the issue of out-of-network billing for privately insured patients has been highlighted as a source of unexpected out-of-pocket charges for patients, even in the setting of an in-network primary surgeon. The Congress recently passed the No Surprises Act to curtail these practices. However, the new law contains exceptions, and its regulatory system has yet to be established. As one of the most frequently performed major surgical procedures, hysterectomy represents a significant exposure to out-of-network bills among nonelderly females in the United States. OBJECTIVE: To describe the extent and nature of out-of-network bills at the time of hysterectomy among privately insured patients in the context of the recently passed No Surprises Act. STUDY DESIGN: We performed a retrospective cohort study of women aged 18 to 64 years who underwent simple hysterectomy from 2008 to 2018 with an in-network primary surgeon in the IBM Watson Marketscan claims database, which includes data from over 350 different payers. We identified out-of-network claims for facility or professional services and analyzed the frequency, size, and source of the payments. We used multivariable logistic regression to assess for patient, procedure, and facility characteristics associated with the risk of out-of-network claims. RESULTS: We identified 585,223 hysterectomy cases meeting all the inclusion criteria, and they were evenly split between inpatient (49.6%) and outpatient (50.4%) procedures. Overall, 8.8% of cases included at least 1 out-of-network claim, with median out-of-network expenditures of $553 for inpatient procedures and $438 for outpatient procedures. Compared with professional out-of-network claims, facility out-of-network claims were less common (2.3% vs 7.4%) but far greater in the amount billed (median $8,307 vs $400 inpatient, $3,281 vs $407 outpatient). Among the professional claims, those from midlevel surgical assistants were most frequently out-of-network when present (13.8% inpatient; 20.0% outpatient), whereas out-of-network claims from anesthesia were most common overall and largest (median $890 inpatient, $1,021 outpatient) when present. In a multivariable model, older age, increasing comorbidity, and complications during the stay were associated with higher odds of any out-of-network claim. In contrast, the risk of facility out-of-network claims was more strongly associated with the facility region and the surgical approach, with the highest odds for cases in the North Central region and those using robotic approach. CONCLUSION: Out-of-network bills for privately insured patients at the time of hysterectomy occurred in 8.8% of cases. Approximately one-quarter of these included out-of-network facility claims tended to have higher payments than out-of-network professional claims and may not be prevented by the No Surprises Act. Gynecologic surgeons should be aware of the potential out-of-network charges for ancillary services at the time of surgery, particularly the network status of the facility, to provide maximal transparency and financial protection to our patients.

Time Costs and Out-of-Pocket Costs in Patients With Chronic Hepatitis C in a Publicly Funded Health System.

OBJECTIVES: Chronic hepatitis C (CHC) infection affects more than 70 million people worldwide and imposes considerable health and economic burdens on patients and society. This study estimated 2 understudied components of the economic burden, patient out-of-pocket (OOP) costs and time costs, in patients with CHC in a tertiary hospital clinic setting and a community clinic setting. METHODS: This was a multicenter, cross-sectional study with hospital-based (n = 174) and community-based (n = 101) cohorts. We used a standardized instrument to collect healthcare resource use, time, and OOP costs. OOP costs included patient-borne costs for medical services, nonprescription drugs, and nonmedical expenses related to healthcare visits. Patient and caregiver time costs were estimated using an hourly wage value derived from patient-reported employment income and, where missing, derived from the Canadian census. Sensitivity analysis explored alternative methods of valuing time. Costs were reported in 2020 Canadian dollars. RESULTS: The mean 3-month OOP cost was $55 (95% confidence interval [CI] $21-$89) and $299 (95% CI $170-$427) for the community and hospital cohorts, respectively. The mean 3-month patient time cost was $743 (95% CI $485-$1002) (community) and $465 (95% CI $248-$682) (hospital). The mean 3-month caregiver time cost was $31 (95% CI $0-$63) (community) and $277 (95% CI $174-$380) (hospital). Patients with decompensated cirrhosis bore the highest costs. CONCLUSIONS: OOP costs and patient and caregiver time costs represent a considerable economic burden to patient with CHC, equivalent to 14% and 21% of the reported total 3-month income for the hospital-based and community-based cohorts, respectively.

Cancer treatment-related financial toxicity experienced by patients in low- and middle-income countries: a scoping review.

PURPOSE: In the past decade, literature has called attention to financial toxicities experienced by cancer patients. Though studies have addressed research questions in high-income countries, there remains a paucity of in-depth reviews regarding low- and middle-income countries (LMICs). Our scoping review provides an overview of treatment-related financial toxicities experienced by cancer patients in LMICs. METHODS: A systematic search was conducted in MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials. English peer-reviewed articles that (a) explored patients' experience with financial toxicity due to cancer treatment (b) were specific to LMICs as defined by the World Bank and (c) focused on qualitative data were included. Details regarding participants and main findings were extracted and synthesized. RESULTS: The search yielded 6290 citations, and 42 studies across 3 low-income, 9 lower-middle-income and 8 upper-middle-income countries. Main themes identified included cancer patients encountered various material hardships, managed costs with different coping behaviours and experienced negative psychological responses to their financial burden. Higher levels of financial toxicities were associated with patient characteristics such as lower socio-economic status and lack of insurance, as well as patient outcomes such as lower quality of life. CONCLUSION: Cancer patients in LMIC experience deleterious financial toxicities as a result of treatment. This comprehensive characterization of financial toxicities will better allow health systems to adopt evidence-based mitigation strategies to reduce the financial burden on patients.

How does the onset of physical disability or dementia in older adults affect economic wellbeing and co-payments for health care? the impact of gender.

BACKGROUND: Existing studies have illustrated how the onset of physical disability or dementia negatively impacts economic wellbeing and increases out of pocket costs. However, little is known about this relationship in older individuals. Consequently, this study aimed to identify how the onset of physical disability or dementia in older adults affects economic wellbeing and out of pocket costs, and to explore the impact of gender in the context of Australia. METHODS: The data was collected from a large, randomized clinical study, ASPirin in Reducing Events in the Elderly (ASPREE). Two generalized linear models (with and without interaction effects) of total out of pocket costs for those who did and did not develop physical disability or dementia were generated, with adjustment for sociodemographic characteristics at baseline. RESULTS: We included 8,568 older Australian individuals with a mean age of 74.8 years and 53.2% being females. After adjustment for the baseline sociodemographic characteristics, the onset of physical disability did statistically significantly raise out of pocket costs (cost ratio = 1.25) and costs among females were 13.1% higher than males. CONCLUSIONS: This study highlights that classifying different types of health conditions to identify the drivers of out of pocket costs and to explore the gender differences in a long-term follow-up is of importance to examine the financial impact on the older population. These negative financial impacts and gender disparities of physical disability and dementia must be considered by policymakers.

Patient-Reported Out-of-Pocket Costs and Financial Toxicity During Early-Phase Oncology Clinical Trials.

BACKGROUND: Clinical trials are an important therapeutic option for patients with cancer. Although financial burden in cancer treatment is well documented, the financial burden associated with clinical trials is not well understood. PATIENTS AND METHODS: We conducted a survey regarding economic burden and financial toxicity in patients with cancer enrolled in phase I clinical trials for >1 month. Financial toxicity score was assessed using the Comprehensive Score for Financial Toxicity survey. Patients also reported monthly out-of-pocket (OOP) costs. RESULTS: Two hundred and thirteen patients completed the survey (72% non-Hispanic White; 45% with annual income ≤$60,000; 50% lived >300 miles from the clinic; 37% required air travel). Forty-eight percent of patients had monthly OOP costs of at least $1,000. Fifty-five percent and 64% of patients reported unanticipated medical and nonmedical expenses, respectively. Worse financial toxicity was associated with yearly household income <$60,000 (odds ratio [OR]: 2.7; p = .008), having unanticipated medical costs (OR: 3.2; p = .024), and living >100 miles away from the clinical trial hospital (OR: 2.3; p = .043). Non-White or Hispanic patients (OR: 2.5; p = .011) and patients who were unemployed or not working outside the home (OR: 2.5; p = .016) were more likely to report high unanticipated medical costs. CONCLUSION: Among patients with cancer participating in clinical trials, economic burden is high, and most of patients' OOP costs were nonmedical costs. Financial toxicity is disproportionally higher in patients with lower income and those who travel farther, and unexpected medical costs were more common among non-White or Hispanic patients. OOP costs can be substantial and are often unexpected for patients. IMPLICATIONS FOR PRACTICE: The financial burden of cancer treatment is well documented, but there are limited data regarding the financial burden associated with cancer clinical trials. This study surveyed 213 patients enrolled in early-phase clinical trials. Monthly out-of-pocket costs were at least $1000 for nearly half of patients. Worse financial toxicity was associated with income <$60,000 and living farther away from the hospital. Racial/ethnic minorities had higher rates of unanticipated medical costs. These data help to quantify the high financial burden for patients and may reveal a cause of disparities in clinical trial enrollment for underrepresented populations.

Cost sharing, postpartum contraceptive use, and short interpregnancy interval rates among commercially insured women.

BACKGROUND: Increasing access to effective birth control after childbirth may meet many women's preferences and reduce short interpregnancy interval rates. Eliminating out-of-pocket costs for contraception has been reported to increase the use of the most effective methods among women with employer-based insurance, but the prevalence and effects of patient cost sharing for contraception have not been studied during the postpartum period. OBJECTIVE: This study aimed to examine the association between cost sharing for long-acting reversible contraception and postpartum contraception use patterns and pregnancies in the 12 months after delivery. STUDY DESIGN: We conducted a retrospective cohort analysis of commercially insured women undergoing childbirth from 2014 to 2018 using Optum's (Eden Prairie, MN) de-identified Clinformatics Data Mart database. This large national database includes nonretired employees and their dependents who are enrolled in health insurance plans sponsored by large- or medium-sized US-based employers. Women with 12 months of continuous enrollment postpartum were included. Childbirth, pregnancy, and contraceptive method (female sterilization, long-acting reversible contraceptives, other hormonal methods, and no prescription method observed) were identified using claims data. Contraceptive use patterns were observed at 3, 6, and 12 months postpartum and adjusted for individual and plan characteristics. Median out-of-pocket costs were $0 for sterilization and other hormonal methods but nonzero for long-acting reversible contraception. We therefore used simple and multivariable logistic regressions to examine the association between plan-level cost sharing (no cost sharing, $0; low cost sharing, >$0-<$200; and high cost sharing, ≥$200 out-of-pocket cost) for any long-acting reversible contraceptive insertion and contraceptive use patterns and short interpregnancy interval rates, controlling for age, household income, race and ethnicity, region, and insurance plan type. RESULTS: Among 25,298 plans with cost sharing data, we identified 172,941 women with continuous enrollment for 12 months postpartum, including 82,500 (47.7%) in no cost sharing, 22,595 (13.1%) in low cost sharing, and 67,846 (39.2%) in high cost sharing plans. The percentage of postpartum women in the study sample using any prescription contraceptive method was 39.5% by 3 months, 43.8% by 6 months, and 46.0% by 12 months. At all time points, postpartum women in no cost sharing plans had a higher predicted probability of long-acting reversible contraceptive use (eg, at 12 months: no cost sharing, 22.0%; low cost-sharing, 17.5%; high cost sharing, 18.3%; P<.001) and a lower predicted probability of no prescription method use (eg, at 12 months: no cost sharing, 51.8%; low cost sharing, 55.0%; high cost sharing, 54.9%; P<.001) than those in low or high cost sharing plans. Predicted probabilities of female sterilization and other hormonal method use did not differ substantively by plan cost sharing for long-acting reversible contraception at any time point. The proportion of women experiencing a short interpregnancy interval was low (1.9% by 3 months, 1.9% by 6 months, 2.0% by 12 months) and did not differ by plan cost sharing for long-acting reversible contraception at any time point. CONCLUSION: Out-of-pocket costs for long-acting reversible contraception influence the method of contraception used by postpartum women with employer-based insurance. Eliminating financial barriers to long-acting reversible contraception access after childbirth may help women initiate their preferred method and increase the use of long-acting reversible contraceptives among interested women who otherwise might utilize less effective methods.

Patient cost sharing during poly(adenosine diphosphate-ribose) polymerase inhibitor treatment in ovarian cancer.

BACKGROUND: More patients with ovarian cancer are being treated with poly(adenosine diphosphate-ribose) polymerase inhibitors because regulatory agencies have granted these drugs new approvals for a variety of treatment indications. However, poly(adenosine diphosphate-ribose) polymerase inhibitors are expensive. When administered as a maintenance therapy, these drugs may be administered for months or years. How much of this cost patients experience as out-of-pocket spending is unknown. OBJECTIVE: This study aimed to estimate the out-of-pocket spending that patients experience during poly(adenosine diphosphate-ribose) polymerase inhibitor treatment and to characterize which healthcare services account for that spending. STUDY DESIGN: A retrospective cohort study was performed with a sample of patients with ovarian cancer treated between 2014 and 2017 with olaparib, niraparib, or rucaparib. Patients were identified using MarketScan, a health insurance claims database. All insurance claims during poly(adenosine diphosphate-ribose) polymerase inhibitor treatment were collected. The primary outcome variable was the patients' out-of-pocket spending (copayment, coinsurance, and deductibles) during poly(adenosine diphosphate-ribose) polymerase inhibitor treatment for the medication itself. Other outcomes of interest included out-of-pocket spending for other healthcare services, the types and frequency of other healthcare services used, health plan spending, the estimated proportion of patients' household income used each month for healthcare, and patients' out-of-pocket spending immediately before poly(adenosine diphosphate-ribose) polymerase inhibitor treatment. RESULTS: We identified 503 patients with ovarian cancer with a median age of 55 years (interquartile range, 50-62 years); 83% of those had out-of-pocket spendings during poly(adenosine diphosphate-ribose) polymerase inhibitor treatment. The median treatment duration was 124 days (interquartile range, 66-240 days). The mean out-of-pocket spending for poly(adenosine diphosphate-ribose) polymerase inhibitors was $305 (standard deviation, $2275) per month. On average, this accounted for 44.8% (standard deviation, 34.8%) of the patients' overall monthly out-of-pocket spending. The mean out-of-pocket spending for other healthcare services was $165 (standard deviation, $769) per month. Health plans spent, on average, $12,661 (standard deviation, $15,668) per month for poly(adenosine diphosphate-ribose) polymerase inhibitors and $7108 (standard deviation, $15,254) per month for all other healthcare services. The cost sharing for office visits, laboratory tests, and imaging studies represented the majority of non-poly(adenosine diphosphate-ribose) polymerase inhibitor treatment out-of-pocket spending. The average amount patients paid for all healthcare services per month during poly(adenosine diphosphate-ribose) polymerase inhibitor treatment was $470 (standard deviation, $2407), which was estimated to be 8.7% of the patients' monthly household income. The mean out-of-pocket spending in the 12 months before poly(adenosine diphosphate-ribose) polymerase inhibitor treatment was $3110 (standard deviation, $6987). CONCLUSION: Patients can face high out-of-pocket costs for poly(adenosine diphosphate-ribose) polymerase inhibitors, although the sum of cost sharing for other healthcare services used during poly(adenosine diphosphate-ribose) polymerase inhibitor treatment is often higher. The spending on healthcare costs consumes a large proportion of these patients' household income. Patients with ovarian cancer experience high out-of-pocket costs for healthcare, both before and during poly(adenosine diphosphate-ribose) polymerase inhibitor treatment.

Patient and family financial burden associated with cancer treatment in Canada: a national study.

GOAL: To determine patient-reported financial and family burden associated with treatment of cancer in the previous 28 days across Canada. METHODS: A self-administered questionnaire (P-SAFE v7.2.4) was completed by 901 patients with cancer from twenty cancer centres nationally (344 breast, 183 colorectal, 158 lung, 216 prostate) measuring direct and indirect costs related to cancer treatment and foregone care. Monthly self-reported out-of-pocket-costs (OOPCs) included drugs, homecare, homemaking, complementary/ alternative medicines, vitamins/supplements, family care, accommodations, devices, and "other" costs. Travel and parking costs were captured separately. Patients indicated if OOPC, travel, parking, and lost income were a financial burden. RESULTS: Mean 28-day OOPCs were CA$518 (US Purchase Price Parity [PPP] $416), plus CA$179 (US PPP $144) for travel and CA$84 (US PPP $67) for parking. Patients self-reporting high financial burden had total OOPCs (33%), of CA$961 (US PPP $772), while low-burden participants (66%) had OOPCs of CA$300 (US PPP $241). "Worst burden" respondents spent a mean of 50.7% of their monthly income on OOPCs (median 20.8%). Among the 29.4% who took time off work, patients averaged 18.0 days off. Among the 26.0% of patients whose caregivers took time off work, caregivers averaged 11.5 days off. Lastly, 41% of all patients had to reduce spending. Fifty-two per cent of those who reduced spending were families earning < CA$50,000/year. CONCLUSIONS: In our Canadian sample, high levels of financial burden exist for 33% of patients, and the severity of burden is higher for those with lower household incomes.