Project description:BackgroundThe 340B Drug Pricing Program entitles qualifying hospitals to discounts on outpatient drugs, increasing the profitability of drug administration. By tying the program eligibility of hospitals to their Disproportionate Share Hospital (DSH) adjustment percentage, which reflects the proportion of hospitalized patients who are low-income, the program is intended to expand resources for underserved populations but provides no direct incentives for hospitals to use financial gains to enhance care for low-income patients.MethodsWe used Medicare claims and a regression-discontinuity design, taking advantage of the threshold for program eligibility among general acute care hospitals (DSH percentage, >11.75%), to isolate the effects of the program on hospital-physician consolidation (i.e., acquisition of physician practices or employment of physicians by hospitals) and on the outpatient administration of parenteral drugs by hospital-owned facilities in three specialties in which parenteral drugs are frequently used. For low-income patients, we also assessed the effects of the program on the provision of care by hospitals and on mortality.ResultsHospital eligibility for the 340B Program was associated with 2.3 more hematologist-oncologists practicing in facilities owned by the hospital, or 230% more hematologist-oncologists than expected in the absence of the program (P=0.02), and with 0.9 (or 900%) more ophthalmologists per hospital (P=0.08) and 0.1 (or 33%) more rheumatologists per hospital (P=0.84). Program eligibility was associated with significantly higher numbers of parenteral drug claims billed by hospitals for Medicare patients in hematology-oncology (90% higher, P=0.001) and ophthalmology (177% higher, P=0.03) but not rheumatology (77% higher, P=0.12). Program eligibility was associated with lower proportions of low-income patients in hematology-oncology and ophthalmology and with no significant differences in hospital provision of safety-net or inpatient care for low-income groups or in mortality among low-income residents of the hospitals' local service areas.ConclusionsThe 340B Program has been associated with hospital-physician consolidation in hematology-oncology and with more hospital-based administration of parenteral drugs in hematology-oncology and ophthalmology. Financial gains for hospitals have not been associated with clear evidence of expanded care or lower mortality among low-income patients. (Funded by the Agency for Healthcare Research and Quality and others.).

Project description:ImportanceThe federal 340B program lowers the acquisition cost of prescription drugs and places no limits on what hospitals charge payers. Congress established the program to allow 340B profits (the difference between payments and acquisition costs) to subsidize other safety-net services. Little is known about the magnitude of revenues and profits from the 340B program among participating hospitals.ObjectiveTo report revenues and estimated profits from the 340B program that hospitals collect from Medicare and Medicare beneficiaries for outpatient clinic administration of prescription drugs covered under Medicare Part B.Design, setting, and participantsThis cross-sectional descriptive study used 100% Medicare outpatient Part B claims from January 1, 2013, to December 31, 2016, from fee-for-service Medicare beneficiaries administered separately payable drugs at general acute care nonprofit or public hospitals without special payment designations. Claims data (N = 11 298 860) were aggregated to the hospital-year level (N = 6000) and linked to hospital finances and 340B participation from Medicare cost reports and the 340B covered entity list.Main outcomes and measuresOutcomes studied were revenue and estimated profits, assuming a 50% discount from 340B-discounted drug administrations to Medicare patients, as well as Medicare 340B profits relative to hospital net operating revenue, uncompensated care, and disproportionate share hospital payments.ResultsDuring the study period, hospitals received approximately $2.1 billion in 340B revenue from Medicare in 2013, increasing to $3.7 billion in 2016. Estimated 340B profits from Medicare in 2016 totaled $1.9 billion, and per-hospital estimated 340B profits were $2.5 million but exhibited variability (median, $0.8 million; interquartile range, $0.1 million-$2.8 million). In 2016, median estimated 340B profits from Medicare were 0.3% (interquartile range, 0.1%-0.7%; mean, 0.4%) of hospital operating budgets and 9.4% (interquartile range, 1.8%-26.5%; mean, 16.6%) of hospital uncompensated care costs.Conclusions and relevanceEstimated profits that hospitals derived from administering 340B-discounted drugs to Medicare patients are small compared with operating budgets yet substantial compared with uncompensated care costs for many hospitals. Revenue and profit estimates from 340B-discounted drugs represent a lower bound because data on revenue from the sale of outpatient retail dispensed drugs by hospital contract pharmacies and commercial insurer claims are not available.

Project description:ObjectiveThe 340B program allows safety-net hospitals to acquire discounted outpatient drugs and charge payers full price. We examined whether 340B participation increases safety-net engagement.Data sources340B participation data, Medicare hospital cost reports, American Hospital Association Survey, and Schedule 990 nonprofit hospital tax returns.Study designQuasi-experimental difference-in-differences design comparing 340B hospitals (the "treatment" group) before and after participating to changes over time to three alternative "control" groups: all other nonprofit and public hospitals, hospitals that are not participating during our study, and hospitals that were not-yet-participating but started after 2015. Outcome measures include a range of safety-net care measures that are alternatives to the standard uncompensated care: charity care, community benefit spending, charity care policies, and low-profit service-line provision.Data extractionWe extracted data on all nonprofit and public hospitals from 2011 to 2015. We linked 340B participation data to Medicare hospital cost reports and American Hospital Association data using Medicare hospital identifiers. 990 Data was linked on name and address.Principal findingsNew 340B participation was not associated with a change in uncompensated care, but was associated with a 28.9 percent increase in charity care spending (SE = 8.8), or about $880,000 per hospital. However, total community benefit spending (including charity care) did not change. 340B was associated with an increase in the probability of offering discounted care (4.3 percentage points, SE = 1.6) from 84 to 88 percent and an increase in the income eligibility limit for discounted care (18.9 percentage points, SE = 5.6) from 294 to 313 percent. Participation was not associated with the probability of offering low-profit medical care services.ConclusionsAlternative measures show that newly participating hospitals may increase charity care, potentially through offering more patients discounted care. However, increases appear to be fully offset by reductions in other community benefit programs.

Project description:ImportanceThe 340B program provides discounts on outpatient drugs to certain hospitals and federally supported clinics (covered entities) that can be used to generate revenue to fund safety net care. While numerous studies have found no association between 340B and safety net care provision for most hospital covered entities, less is known about whether federally qualified health centers (FQHCs), the largest group of covered entities after hospitals, use the program to enhance safety net care.ObjectiveTo assess whether a proxy for 340B revenue was associated with increased safety net care provision among FQHCs.Design and settingThis descriptive, retrospective cohort study examined care provided from 2005 to 2022 by 1468 FQHCs that submitted to the Health Resources and Services Administration Uniform Data System. FQHC and year-level fixed effects were included, as well as a control for differential Medicaid expansion over time. The data were analyzed between March and December 2023.ExposureOne-year lagged number of locations registered to dispense or administer 340B-discounted drugs (registered locations), which included child sites, in-house pharmacies, and contract pharmacies in the 340B Outpatient Pharmacy Affairs Database.Main outcomesNatural logarithm of patient volume by payer, low-income status, and use of enabling services. Natural logarithm of visits in which low-profit preventive services were provided.ResultsAn additional registered location was associated with increased patient volume, especially for uninsured (0.4%; 95% CI, 0.3%-0.5%) and privately insured (0.4%; 95% CI, 0.2%-0.5%) patients and low-income (0.4%; 95% CI, 0.2%-0.6%), unhoused (0.3%; 95% CI, 0.1%-0.5%), and non-English-speaking (0.3%; 95% CI, 0.1%-0.5%) patients. An additional registered location was associated with increased visits with an HIV test (0.7%; 95% CI, 0.4%-0.9%), serum lead test (0.8%; 95% CI, 0.6%-1.1%), seasonal influenza shot (0.4%; 95% CI, 0.3%-0.5%), Papanicolaou smear (0.5%; 95% CI, 0.4%-0.7%), and tobacco cessation counseling (1.0%; 95% CI, 0.5%-1.4%). Across the study period, the average annual increase in locations was 1.5.Conclusions and relevanceThe results of this cohort study suggest that there are statistically significant increases in the provision of low-profit but high-value preventive services and care to safety net populations (those who lack insurance, have a low income, or require enabling services) and that, like public hospitals, FQHCs might use 340B revenues to enhance safety net care. This finding may inform debates on the 340B program by supporting differential 340B reforms across hospital and nonhospital covered entities.

Project description:ImportanceThe 340B Drug Pricing Program requires manufacturers to offer discounted drug prices to support safety net hospitals and clinics (covered entities) providing care to low-income populations. Amid expansion, the program has received criticism and calls for reform.ObjectiveTo assess the literature on the foundations of and outcomes associated with the 340B program.Evidence reviewThe databases searched in this scoping review included PubMed, Embase, EconLit, National Bureau of Economic Research (NBER), Westlaw, the Department of Health and Human Services Office of the Inspector General (HHS-OIG) website, the Government Accountability Office (GAO) website, and Google in February 2023 for peer-reviewed literature, legal publications, opinion pieces, and government agency and committee reports related to the 340B program.FindingsAmong a collected 900 documents, 289 met inclusion criteria: 83 articles from PubMed, 12 articles from Embase, 2 articles from EconLit, 1 article from NBER, 28 articles from Westlaw, 23 legislative history documents, 103 documents from Google, 11 GAO reports, and 26 HHS-OIG reports. Included literature pertained to 4 stakeholders in the 340B program: covered entities, pharmacies, pharmaceutical manufacturers, and patients. This literature showed that hospitals, clinics, and pharmacies generated revenue and manufacturers have forgone revenue from 340B discounted drugs. Audits of covered entities found low rates of compliance with 340B program requirements, whereas mixed evidence was uncovered on how covered entities used their 340B revenue, with some studies suggesting use to expand health care services for low-income populations and others to acquire physician practices and open sites in higher-income neighborhoods. These studies were hampered by a lack of transparency and reporting on the use of 340B revenue. Studies revealed patient benefits from access to expanded health care services, but there was mixed evidence on patient cost savings. Although the review identified considerable research on 340B hospitals, pharmacies, and patients, less research was found evaluating the 340B program's effect on nonhospital covered entities, drug pricing, and racial and ethnic minority groups.Conclusions and relevanceIn this scoping review of the 340B program, we found that the 340B program was associated with financial benefits for hospitals, clinics, and pharmacies; improved access to health care services for patients; and substantial costs to manufacturers. Increased transparency regarding the use of 340B program revenue and strengthened rulemaking and enforcement authority for the Health Resources and Services Administration would support compliance and help ensure the 340B program achieves its intended purposes.

Project description:ImportanceSafety-net hospitals (SNHs) are ideal sites to deliver addiction treatment to patients with substance use disorders (SUDs), but the availability of these services within SNHs nationwide remains unknown.ObjectiveTo examine differences in the delivery of different SUD programs in SNHs vs non-SNHs across the US and to determine whether these differences are increased in certain types of SNHs depending on ownership.Design, setting, and participantsThis cross-sectional analysis used data from the 2021 American Hospital Association Annual Survey of Hospitals to examine the associations of safety-net status and ownership with the availability of SUD services at acute care hospitals in the US. Data analysis was performed from January to March 2022.Main outcomes and measuresThis study used 2 survey questions from the American Hospital Association survey to determine the delivery of 5 hospital-based SUD services: screening, consultation, inpatient treatment services, outpatient treatment services, and medications for opioid use disorder (MOUD).ResultsA total of 2846 hospitals were included: 409 were SNHs and 2437 were non-SNHs. The lowest proportion of hospitals reported offering inpatient treatment services (791 hospitals [27%]), followed by MOUD (1055 hospitals [37%]), and outpatient treatment services (1087 hospitals [38%]). The majority of hospitals reported offering consultation (1704 hospitals [60%]) and screening (2240 hospitals [79%]). In multivariable models, SNHs were significantly less likely to offer SUD services across all 5 categories of services (screening odds ratio [OR], 0.62 [95% CI, 0.48-0.76]; consultation OR, 0.62 [95% CI, 0.47-0.83]; inpatient services OR, 0.73 [95% CI, 0.55-0.97]; outpatient services OR, 0.76 [95% CI, 0.59-0.99]; MOUD OR, 0.6 [95% CI, 0.46-0.78]). With the exception of MOUD, public or for-profit SNHs did not differ significantly from their non-SNH counterparts. However, nonprofit SNHs were significantly less likely to offer all 5 SUD services compared with their non-SNH counterparts (screening OR, 0.52 [95% CI, 0.41-0.66]; consultation OR, 0.56 [95% CI, 0.44-0.73]; inpatient services OR, 0.45 [95% CI, 0.33-0.61]; outpatient services OR, 0.58 [95% CI, 0.44-0.76]; MOUD OR, 0.61 [95% CI, 0.46-0.79]).Conclusions and relevanceIn this cross-sectional study of SNHs and non-SNHs, SNHs had significantly lower odds of offering the full range of SUD services. These findings add to a growing body of research suggesting that SNHs may face additional barriers to offering SUD programs. Further research is needed to understand these barriers and to identify strategies that support the adoption of evidence-based SUD programs in SNH settings.

Project description:BackgroundThe 340B Drug Pricing Program has been controversial since its inception in 1992, a major criticism being that 340B hospitals use more outpatient drugs, and more expensive drugs, because of financial incentives to "make money" through the program. The goal of this study was to determine whether characteristics of patients treated at 340B hospitals, and affiliation of hospitals with NCI-designated cancer centers, would explain higher Part B drug costs and use of more expensive chemotherapy drugs.MethodsThis is an observational study using data from SEER-Medicare and 340B entity database. Fee-for-service Medicare beneficiaries who were first diagnosed with cancer between 1/1/2013 and 12/31/2015 were included. Hospital, patient, and cancer/clinical characteristics were used as predictors of both overall Part B drug costs and use of expensive chemotherapy drugs. Patient characteristics and cancer conditions were compared between those who were treated at 340B and non-340B hospitals, and between those who used and who did not use any expensive chemotherapy treatment. Independent relationships between overall Part B drug costs and patients' 340B status, and between patients' use of expensive chemotherapy drug and patients' 340B status were evaluated in multivariate analyses, using a "stepwise" generalized estimating equation modeling approach.ResultsWe found that patients at 340B hospitals had a somewhat higher chance of using one of the ten expensive chemotherapy drugs, and somewhat higher overall drug costs, but these relationships became non-significant when patient, cancer/clinical factors, and cancer center status were considered. Compared to the reference patients, patients who were treated in an NCI-designated cancer center or a hospital affiliated with such center, who had certain types of cancers (e.g., B-cell), or had advanced-stage disease had a higher chance to use expensive chemotherapy treatment; patients who were older, survived the first 12 months upon diagnosis, had advanced-stage disease, or had more drug claims had higher drug costs.ConclusionsHospital 340B status was not significantly associated with use of more expensive cancer drugs or drug costs once other relevant factors (e.g., cancer center status, advanced-stage disease) were taken into account.

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The unintended consequences of the 340B safety-net drug discount program.

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The unintended consequences of the 340B safety-net drug discount program.

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