The unintended consequences of the 340B safety-net drug discount program.
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SUBMITTER: Thomas S
PROVIDER: S-EPMC7080379 | biostudies-literature |
REPOSITORIES: biostudies-literature
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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.).
| S-EPMC6073067 | biostudies-literature
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.
| S-EPMC6824218 | biostudies-literature
Project description:OBJECTIVE:The 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 SOURCES:340B participation data, Medicare hospital cost reports, American Hospital Association Survey, and Schedule 990 nonprofit hospital tax returns. STUDY DESIGN:Quasi-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 EXTRACTION:We 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 FINDINGS:New 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. CONCLUSIONS:Alternative 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.
| S-EPMC7080377 | biostudies-literature
Project description:OBJECTIVE:To examine the impact of the 340B drug discount program on the site of cancer drug administration and cancer care spending in Medicare. DATA SOURCES/STUDY SETTING:2010-2013 Medicare claims data for a random sample of Medicare Fee-for-Service beneficiaries with cancer. STUDY DESIGN:We identified the 340B effect using variation in the availability of 340B hospitals across markets. We considered beneficiaries from markets that newly gained a 340B hospital during the study period (new 340B markets) as the treatment group. Beneficiaries in markets with no 340B hospital were the control group. We used a difference-in-differences approach with market fixed effects. DATA COLLECTION:Secondary data analysis. PRINCIPAL FINDINGS:The probability of a patient receiving cancer drug administration in hospital outpatient departments (HOPDs) versus physician offices increased 7.8 percentage points more in new 340B markets than in markets with no 340B hospital. Per-patient spending on other cancer care increased $1,162 more in new 340B markets than in markets with no 340B hospital. CONCLUSIONS:The 340B program shifted the site of cancer drug administration to HOPDs and increased spending on other cancer care. As the program expands, continuing assessment of its impact on service utilization and spending would be needed.
| S-EPMC6153182 | biostudies-literature
Project description:ObjectiveTo explore the impact of the Hospital Readmissions Reduction Program (HRRP) on hospitals serving vulnerable populations.Data sources/study settingMedicare inpatient claims to calculate condition-specific readmission rates. Medicare cost reports and other sources to determine a hospital's share of duals, profit margin, and characteristics.Study designRegression analyses and projections were used to estimate risk-adjusted readmission rates and financial penalties under the HRRP. Findings were compared across groups of hospitals, determined based on their share of duals, to assess differential impacts of the HRRP.Principal findingsBoth patient dual-eligible status and a hospital's dual-eligible share of Medicare discharges have a positive impact on risk-adjusted hospital readmission rates. Under current Centers for Medicare and Medicaid Service methodology, which does not adjust for socioeconomic status, high-dual hospitals are more likely to have excess readmissions than low-dual hospitals. As a result, HRRP penalties will disproportionately fall on high-dual hospitals, which are more likely to have negative all-payer margins, raising concerns of unintended consequences of the program for vulnerable populations.ConclusionsPolicies to reduce hospital readmissions must balance the need to ensure continued access to quality care for vulnerable populations.
| S-EPMC4231573 | biostudies-literature
Project description:ImportanceAlthough readmission rates are declining under Medicare's Hospital Readmissions Reduction Program (HRRP), concerns remain that the HRRP will harm quality at safety-net hospitals because they are penalized more often. Disparities between white and black patients might widen because more black patients receive care at safety-net hospitals. Disparities may be particularly worse for clinical conditions not targeted by the HRRP because hospitals might reallocate resources toward targeted conditions (acute myocardial infarction, pneumonia, and heart failure) at the expense of nontargeted conditions.ObjectiveTo examine disparities in readmission rates between white and black patients discharged from safety-net or non-safety-net hospitals after the HRRP began, evaluating discharges for any clinical condition and the subsets of targeted and nontargeted conditions.Design, setting, and participantsCohort study conducting quasi-experimental analyses of patient hospital discharges for any clinical condition among fee-for-service Medicare beneficiaries from 2007 to 2015 after controlling for patient and hospital characteristics. Changes in disparities were measured within safety-net and non-safety-net hospitals after the HRRP penalties were enforced and compared with prior trends. These analyses were then stratified by targeted and nontargeted conditions. Analyses were conducted from October 1, 2017, through August 31, 2018.Main outcomes and measuresTrends in 30-day readmission rates among white and black patients by quarter and differences in trends across periods.ResultsThe study sample included 58 237 056 patient discharges (black patients, 9.8%; female, 57.7%; mean age [SD] age, 78.8 [7.9] years; nontargeted conditions, 50 372 806 [86.5%]). Within safety-net hospitals, disparities in readmission rates for all clinical conditions widened between black and white patients by 0.04 percentage point per quarter in the HRRP penalty period (95% CI, 0.01 to 0.07; P = .01). This widening was driven by nontargeted conditions (0.05 percentage point per quarter [95% CI, 0.01 to 0.08]; P = .006), whereas disparities for the HRRP-targeted conditions did not change (with an increase of 0.01 percentage point per quarter [95% CI, -0.07 to 0.10]; P = .74). Within non-safety-net hospitals, racial disparities remained stable in the HRRP penalty period across all conditions, whether the conditions were HRRP-targeted or nontargeted.Conclusions and relevanceFindings from this study suggest that disparities are widening within safety-net hospitals, specifically for non-HRRP-targeted conditions. Although increases in racial disparities for nontargeted conditions were modest, they represent 6 times more discharges in our cohort than targeted conditions.
| S-EPMC6324411 | biostudies-literature
Project description:Since the early 2000s, China has carried out extensive "grain-for-green" and grazing exclusion practices to combat desertification in the desertification-prone region (DPR). However, the environmental and socioeconomic impacts of these practices remain unclear. We quantify and compare the changes in fractional vegetation cover (FVC) with economic and population data in the DPR before and after the implementation of these environmental programmes. Here we show that climatic change and CO2 fertilization are relatively strong drivers of vegetation rehabilitation from 2001-2020 in the DPR, and the declines in the direct incomes of farmers and herders caused by ecological practices exceed the subsidies provided by governments. To minimize economic hardship, enhance food security, and improve the returns on policy investments in the DPR, China needs to adapt its environmental programmes to address the potential impacts of future climate change and create positive synergies to combat desertification and improve the economy in this region.
| S-EPMC9975221 | biostudies-literature
Project description:Prior to 2010, Medicare payments for consultations (commonly billed by specialists) were substantially higher than for office visits of similar complexity (commonly billed by primary care physicians). In January 2010, Medicare eliminated consultation payments from the Part B Physician Fee Schedule and increased fees for office visits. This change was intended to be budget neutral and to decrease payments to specialists while increasing payments to primary care physicians. We assessed the impact of this policy on spending, volume, and complexity for outpatient office encounters in 2010.We examined outpatient claims from 2007 through 2010 for 2 247 810 Medicare beneficiaries with Medicare Supplemental (Medigap) coverage through large employers in the Thomson Reuters MarketScan Database. We used segmented regression analysis to study changes in spending, volume, and complexity of office encounters adjusted for age, sex, health status, secular trends, seasonality, and hospital referral region."New" office visits largely replaced consultations in 2010. An average of $10.20 more was spent per beneficiary per quarter on physician encounters after the policy (6.5% increase). The total volume of physician encounters did not change significantly. The increase in spending was largely explained by higher office-visit fees from the policy and a shift toward higher-complexity visits to both specialists and primary care physicians.The elimination of consultations led to a net increase in spending on visits to both primary care physicians and specialists. Higher prices, partially owing to the subjectivity of codes in the physician fee schedule, explained the spending increase, rather than higher volumes.
| S-EPMC3547540 | biostudies-literature
Project description:BackgroundThe Open Biomedical Ontologies (OBO) Foundry is a collection of freely available ontologically structured controlled vocabularies in the biomedical domain. Most of them are disseminated via both the OBO Flatfile Format and the semantic web format Web Ontology Language (OWL), which draws upon formal logic. Based on the interpretations underlying OWL description logics (OWL-DL) semantics, we scrutinize the OWL-DL releases of OBO ontologies to assess whether their logical axioms correspond to the meaning intended by their authors.ResultsWe analyzed ontologies and ontology cross products available via the OBO Foundry site http://www.obofoundry.org for existential restrictions (someValuesFrom), from which we examined a random sample of 2,836 clauses.According to a rating done by four experts, 23% of all existential restrictions in OBO Foundry candidate ontologies are suspicious (Cohens' ? = 0.78). We found a smaller proportion of existential restrictions in OBO Foundry cross products are suspicious, but in this case an accurate quantitative judgment is not possible due to a low inter-rater agreement (? = 0.07). We identified several typical modeling problems, for which satisfactory ontology design patterns based on OWL-DL were proposed. We further describe several usability issues with OBO ontologies, including the lack of ontological commitment for several common terms, and the proliferation of domain-specific relations.ConclusionsThe current OWL releases of OBO Foundry (and Foundry candidate) ontologies contain numerous assertions which do not properly describe the underlying biological reality, or are ambiguous and difficult to interpret. The solution is a better anchoring in upper ontologies and a restriction to relatively few, well defined relation types with given domain and range constraints.
| S-EPMC3280341 | biostudies-literature
Project description:Controlling the spread of COVID-19 - even after a licensed vaccine is available - requires the effective use of non-pharmaceutical interventions, e.g., physical distancing, limits on group sizes, mask wearing, etc1-7. To date, such interventions have not been uniformly and/or systematically implemented across the United States of America (US)8. For example, even when under strict stay-at-home orders, numerous jurisdictions in the US granted exceptions and/or were in close proximity to locations with entirely different regulations in place. Here, we investigate the impact of such geographic inconsistencies in epidemic control policies by coupling high-resolution mobility, search, and COVID case data to a mathematical model of SARS-CoV-2 transmission. Our results show that while stay-at-home orders decrease contacts in most areas of the US, some specific activities and venues often see an increase in attendance. As an example, over the month of March 2020, between 10 and 30% of churches in the US saw increases in attendance; even as the total number of visits to churches declined nationally. This heterogeneity, where certain venues see substantial increases in attendance while others close, suggests that closure can cause individuals to find an open venue, even if that requires longer-distance travel. And, indeed, the average distance travelled to churches in the US rose by 13% over the same period, and over the summer, churches with more than 50 average weekly visitors saw an increase of 81% in distance visitors had to travel to attend. Strikingly, our mathematical model reveals that, across a broad range of model parameters, partial measures can often be worse than no measures at all. In the most severe cases, individuals not complying with policies by traveling to neighboring jurisdictions can create epidemics when the outbreak would otherwise have been contained. Indeed, using county-level COVID-19 data, we show that mobility from high-incidence to low-incidence associated with travel for venues like churches, parks, and gyms consistently precedes rising case numbers in the low-incidence counties. Taken together, our data analysis of nearly 120 million church visitors across 184,677 churches, 14 million grocery visitors across 7,662 grocery stores, 13.5 million gym visitors across 5,483 gyms, 7.7 million cases across 3,195 counties, and modeling results highlight the potential unintended consequences of inconsistent epidemic control policies and stress the importance of balancing the societal needs of a population with the risk of an outbreak growing into a large epidemic, and the urgent need for centralized implementation and enforcement of non-pharmaceutical interventions.
| S-EPMC7457624 | biostudies-literature