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Background The 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. Methods This 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. Results We 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. Conclusions Hospital 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.

The goal of eliminating disparities in health care in the United States remains elusive.Even as quality improves on specific measures, disparities often persist.Addressing these disparities must begin with the fundamental step of bringing the nature of the disparities and the groups at risk for those disparities to light by collecting health.

The Centers for Medicare and Medicaid Services (CMS) Hospital Readmissions Reduction Program has focused attention on ways to reduce thirty-day readmissions and on factors affecting readmission risk. Using inpatient data from an urban teaching hospital, we examined how elements of individual characteristics and neighborhood socioeconomic status influenced the likelihood of readmission under a single fixed organizational and staffing structure. Patients living in high-poverty neighborhoods were 24 percent more likely than others to be readmitted, after demographic characteristics and clinical conditions were adjusted for. Married patients were at significantly reduced risk of readmission, which suggests that they had more social support than unmarried patients. These and previous findings that document socioeconomic disparities in readmission raise the question of whether CMS's readmission measures and associated financial penalties should be adjusted for the effects of factors beyond hospital influence at the individual or neighborhood level, such as poverty and lack of social support. [PUBLICATION ABSTRACT]

Abstract BACKGROUND While consistently recommended, the significance of early ambulation after surgery has not been definitively studied. OBJECTIVE To identify the relationship between ambulation on the day of surgery (postoperative day (POD)#0) and 90-d adverse events after lumbar surgery. METHODS The Michigan Spine Surgery Improvement Collaborative (MSSIC) is a prospective multicenter registry of spine surgery patients. As part of routine postoperative care, patients either ambulated on POD#0 or did not. The 90-d adverse events of length of stay (LOS), urinary retention (UR), urinary tract infection (UTI), ileus, readmission, surgical site infection (SSI), pulmonary embolism/deep vein thrombosis (PE/DVT), and disposition to a rehab facility were measured. RESULTS A total of 23 295 lumbar surgery patients were analyzed. POD#0 ambulation was associated with decreased LOS (relative LOS 0.83, P < .001), rehab discharge (odds ratio [OR] 0.52, P < .001), 30-d (OR 0.85, P = .044) and 90-d (OR 0.86, P = .014) readmission, UR (OR 0.73, P = 10), UTI (OR 73, P = .001), and ileus (OR 0.52, P < .001) for all patients. Significant improvements in LOS, rehab discharge, readmission, UR, UTI, and ileus were observed in subset analysis of single-level decompressions (4698 pts), multilevel decompressions (4079 pts), single-level fusions (4846 pts), and multilevel fusions (4413 pts). No change in rate of SSI or DVT/PE was observed for patients who ambulated POD#0. CONCLUSION POD#0 ambulation is associated with a significantly decreased risk for several key adverse events after lumbar spine surgery. Decreasing the incidence of these outcomes would be associated with significant cost savings. As ambulation POD#0 is a modifiable factor in any patient's postoperative care following most spine surgery, it should be encouraged and incorporated into spine-related, enhanced-recovery-after-surgery programs.

In this trial in patients with lumbar central stenosis and moderate-to-severe leg pain and disability, epidural injection of glucocorticoids plus lidocaine offered minimal or no short-term benefit over epidural injection with lidocaine alone with respect to disability and pain. Lumbar spinal stenosis, a common cause of spine-related disability, is the leading reason for spinal surgery in older adults. 1 , 2 Degenerative changes resulting in narrowing of the spinal canal and nerve-root compression can cause back and leg pain, lower-extremity paresthesias, and weakness. 3 , 4 The treatment of symptomatic lumbar stenosis remains controversial. Symptoms of lumbar stenosis are commonly treated with epidural glucocorticoid injections. These injections typically contain a glucocorticoid and an anesthetic, which are thought to relieve pain by reducing nerve-root inflammation and ischemia. 1 An estimated 25% of all epidural glucocorticoid injections administered in the Medicare population and 74% of those . . .

To examine characteristics of the CMS Overall Hospital Quality Star Ratings related to their use by consumers for choosing hospitals. Observational study using secondary data analyses. Hospital Star Rating data reported in February 2019 and additional quality data from California and New York were used, with a mix of analytical approaches including descriptive statistics, correlational analysis, and Poisson regression models. The distribution of hospitals' Star Rating summary scores was tightly compressed, with no hospitals at or near the scores that would be obtained if a hospital were either best or worst across all quality domains. Hospitals did not consistently perform well or poorly across the range of measures and quality groups included in the Star Ratings. On average, for a given quality measure included in the Star Rating program, 12% of 1-star hospitals received top-quartile scores and 16% of 5-star hospitals received bottom-quartile scores. No significant associations were found between hospitals' overall Star Ratings and their performance on a set of condition-specific quality measures for hospitals in California and New York State. Hospitals' overall scores clustered in the middle of the potential distribution of scores; no hospitals were either best at everything or worst at everything. The Star Ratings did not predict hospital quality scores for separate quality measures related to specific medical conditions or health care needs. These 2 observations suggest that the Star Ratings are of limited value to consumers choosing hospitals for specific care needs.

Risk adjustment of quality measures using clinical risk factors is widely accepted; risk adjustment using social risk factors remains controversial. We argue here that social risk adjustment is appropriate and necessary in defined circumstances and that social risk adjustment should be the default option when there are valid empirical arguments for and against adjustment for a given measure. social risk adjustment is an important way to avoid exacerbating inequity in the health care system.

Historically, non–small‐cell lung cancer (NSCLC) patients who are non‐white, have low incomes, low educational attainment, and non‐private insurance have worse survival. We assessed whether differences in survival were attributable to sociodemographic factors, clinical characteristics at diagnosis, or treatments received. We surveyed a multiregional cohort of patients diagnosed with NSCLC from 2003 to 2005 and followed through 2012. We used Cox proportional hazard analyses to estimate the risk of death associated with race/ethnicity, annual income, educational attainment, and insurance status, unadjusted and sequentially adjusting for sociodemographic factors, clinical characteristics, and receipt of surgery, chemotherapy, and radiotherapy. Of 3250 patients, 64% were white, 16% black, 7% Hispanic, and 7% Asian; 36% of patients had incomes < $20 000/y; 23% had not completed high school; and 74% had non‐private insurance. In unadjusted analyses, black race, Hispanic ethnicity, income <$ 60 000/y, not attending college, and not having private insurance were all associated with an increased risk of mortality. Black‐white differences were not statistically significant after adjustment for sociodemographic factors, although patients with patients without a high school diploma and patients with incomes <$40 000/y continued to have an increased risk of mortality. Differences by educational attainment were not statistically significant after adjustment for clinical characteristics. Differences by income were not statistically significant after adjustment for clinical characteristics and treatments. Clinical characteristics and treatments received primarily contributed to mortality disparities by race/ethnicity and socioeconomic status in patients with NSCLC. Additional efforts are needed to assure timely diagnosis and use of effective treatment to lessen these disparities. Using data from the Cancer Care Outcomes Research and Surveillance (CanCORS) consortium, a large, multi‐regional observational study of newly diagnosed cancer patients, we documented higher unadjusted mortality for NSCLC among patients who were black, have lower income, less well‐educated, and with non‐private insurance. We used a series of Cox proportional hazards model to estimate the increased risk of death associated with sociodemographic factors, clinical characteristics, and treatments received to determine what accounted for the disparities. We found that patients’ clinical characteristics and treatments received primarily contributed to the mortality disparities that we observed in patients with NSCLC.

Background By participating in priority-setting activities in research, patients and members of the public help ensure that important questions are incorporated into future research agendas. Surveys, focus groups, and online crowdsourcing are increasingly used to obtain input, yet little is known about how they compare for prioritizing research topics. To address this gap, the Study of Methods for Assessing Research Topic Elicitation and pRioritization (SMARTER) evaluated participant satisfaction with the engagement experience across three prioritization activities. Methods Respondents from Back pain Outcomes using Longitudinal Data (BOLD), a registry of patients 65 years and older with low back pain (LBP), were randomly assigned to one of three interactive prioritization activities: online crowd-voting, in-person focus groups using nominal group technique, and two rounds of a mailed survey (Delphi). To assess quality of experience, participants completed a brief survey; a subset were subsequently interviewed. We used descriptive statistics to characterize participants, and we analyzed responses to the evaluation using a mixed-methods approach, tabulating responses to Likert-scale questions and using thematic analysis of interviews to explore participant understanding of the activity and perceptions of experience. Results The crowd-voting activity had 38 participants, focus groups 39, and the Delphi survey 74. Women outnumbered men in the focus groups and Delphi survey; otherwise, demographics among groups were similar, with participants being predominantly white, non-Hispanic, and college educated. Activities generated similar lists of research priorities, including causes of LBP, improving physician-patient communication, and self-care strategies. The evaluation survey was completed by 123 participants. Of these, 31 across all activities were interviewed about motivations to participate, understanding of activity goals, logistics, clarity of instructions, and the role of patients in research. Focus group participants rated their experience highest, in both the evaluation and interviews. Conclusion Common methods for research prioritization yielded similar priorities but differing perceptions of experience. Such comparative studies are rare but important in understanding methods to involve patients and the public in research. Preferences for different methods may vary across stakeholder groups; this warrants future study. Trial registration NICHSR, HSRP20152274 . Registered 19 February 2015.

Background. Little is known about viral hepatitis testing and infection prevalence among persons in private healthcare organizations (HCOs) in the United States. Methods. To determine the frequency of and characteristics associated with viral hepatitis testing and infection prevalence among adults with access to care, we conducted an observational cohort study among 1.25 million adults from 4 US HCOs and included persons with ≥1 clinical encounter during 2006–2008 and ≥12 months of continuous follow-up before 2009. We compared the number of infections identified with the number expected based on adjusted data from the National Health and Nutrition Examination Survey (NHANES). Results. Of 866 886 persons without a previous hepatitis B virus (HBV) diagnosis, 18.8% were tested for HBV infection, of whom 1.4% tested positive; among 865 659 without a previous hepatitis C virus (HCV) diagnosis, 12.7% were tested, of whom 5.5% tested positive. Less than half of those with ≥2 abnormal alanine aminotransferase (ALT) levels were subsequently tested for HBV or HCV. When tested, Asians (adjusted odds ratio [aOR] 6.33 relative to whites) were most likely HBV infected, whereas those aged 50–59 years were most likely HCV infected (aOR 6.04, relative to age <30 years). Based on estimates from NHANES, nearly one-half of HCV and one-fifth of HBV infections in this population were not identified. Conclusions. Even in this population with access to care and lengthy follow-up, only a fraction of expected viral hepatitis infections were identified. Abnormal ALT levels often but not consistently triggered testing. These findings have implications for the identification and care of 4–5 million US residents with HBV and HCV infection.