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Importance: Recent discussion has focused on questions related to the repeal and replacement of portions of the Affordable Care Act (ACA). However, issues central to the future of health and health care in the United States transcend the ACA provisions receiving the greatest attention. Initiatives directed to certain strategic and infrastructure priorities are vital to achieve better health at lower cost.Objectives: To review the most salient health challenges and opportunities facing the United States, to identify practical and achievable priorities essential to health progress, and to present policy initiatives critical to the nation's health and fiscal integrity.Evidence Review: Qualitative synthesis of 19 National Academy of Medicine-commissioned white papers, with supplemental review and analysis of publicly available data and published research findings.Findings: The US health system faces major challenges. Health care costs remain high at $3.2 trillion spent annually, of which an estimated 30% is related to waste, inefficiencies, and excessive prices; health disparities are persistent and worsening; and the health and financial burdens of chronic illness and disability are straining families and communities. Concurrently, promising opportunities and knowledge to achieve change exist. Across the 19 discussion papers examined, 8 crosscutting policy directions were identified as vital to the nation's health and fiscal future, including 4 action priorities and 4 essential infrastructure needs. The action priorities-pay for value, empower people, activate communities, and connect care-recurred across the articles as direct and strategic opportunities to advance a more efficient, equitable, and patient- and community-focused health system. The essential infrastructure needs-measure what matters most, modernize skills, accelerate real-world evidence, and advance science-were the most commonly cited foundational elements to ensure progress.Conclusions and Relevance: The action priorities and essential infrastructure needs represent major opportunities to improve health outcomes and increase efficiency and value in the health system. As the new US administration and Congress chart the future of health and health care for the United States, and as health leaders across the country contemplate future directions for their programs and initiatives, their leadership and strategic investment in these priorities will be essential for achieving significant progress. [ABSTRACT FROM AUTHOR]

Context: Notifiable disease surveillance is essential to rapidly identify and respond to outbreaks so that further illness can be prevented. Automating reports from clinical laboratories has been proposed to reduce underreporting and delays.Objective: To compare the timeliness and completeness of a prototypal electronic reporting system with that of conventional laboratory reporting.Design: Laboratory-based reports for 5 conditions received at a state health department between July 1 and December 31, 1998, were reviewed. Completeness of coverage for each reporting system was estimated using capture-recapture methods.Setting: Three statewide private clinical laboratories in Hawaii.Main Outcome Measures: The number and date of reports received, by reporting system, laboratory, and pathogen; completeness of data fields.Results: A total of 357 unique reports of illness were identified; 201 (56%) were received solely through the automated electronic system, 32 (9%) through the conventional system only, and 124 (35%) through both. Thus, electronic reporting resulted in a 2.3-fold (95% confidence interval [CI], 2.0-2.6) increase in reports. Electronic reports arrived an average of 3.8 (95% CI, 2.6-5.0) days earlier than conventional reports. Of 21 data fields common to paper and electronic formats, electronic reports were significantly more likely to be complete for 12 and for 1 field with the conventional system. The estimated completeness of coverage for electronic reporting was 80% (95% CI, 75%-85%) [corrected] compared with 38% (95% CI, 36%-41%) [corrected] for the conventional system.Conclusions: In this evaluation, electronic reporting more than doubled the total number of laboratory-based reports received. On average, the electronic reports were more timely and more complete, suggesting that electronic reporting may ultimately facilitate more rapid and comprehensive institution of disease control measures. [ABSTRACT FROM AUTHOR]

Importance: Prescription drug spending is a topic of increased interest to the public and policymakers. However, prior assessments have been limited by focusing on retail spending (Part D-covered drugs), omitting clinician-administered (Part B-covered) drug spending, or focusing on all fee-for-service Medicare beneficiaries, regardless of their enrollment into prescription drug coverage.Objective: To estimate the proportion of health care spending contributed by prescription drugs and to assess spending for retail and clinician-administered prescriptions.Design, Setting, and Participants: Descriptive, serial, cross-sectional analysis of a 20% random sample of fee-for-service Medicare beneficiaries in the United States from 2008 to 2019 who were continuously enrolled in Parts A (hospital), B (medical), and D (prescription drug) benefits, and not in Medicare Advantage.Exposure: Calendar year.Main Outcomes and Measures: Net spending on retail (Part D-covered) and clinician-administered (Part B-covered) prescription drugs; prescription drug spending (spending on Part B-covered and Part D-covered drugs) as a percentage of total per-capita health care spending. Measures were adjusted for inflation and for postsale rebates (for Part D-covered drugs).Results: There were 3 201 284 beneficiaries enrolled in Parts A, B, and D in 2008 and 4 502 718 in 2019. In 2019, beneficiaries had a mean (SD) age of 71.7 (12.0) years, documented sex was female for 57.7%, and 69.5% had no low-income subsidies. Total per-capita spending was $16 345 in 2008 and $20 117 in 2019. Comparing 2008 with 2019, per-capita Part A spending was $7106 (95% CI, $7084-$7128) vs $7120 (95% CI, $7098-$7141), Part B drug spending was $720 (95% CI, $713-$728) vs $1641 (95% CI, $1629-$1653), Part B nondrug spending was $5113 (95% CI, $5105-$5122) vs $6702 (95% CI, $6692-$6712), and Part D net spending was $3122 (95% CI, $3117-$3127) vs $3477 (95% CI, $3466-$3489). The proportion of total annual spending attributed to prescription drugs increased from 24.0% in 2008 to 27.2% in 2019, net of estimated rebates and discounts.Conclusions and Relevance: In 2019, spending on prescription drugs represented approximately 27% of total spending among fee-for-service Medicare beneficiaries enrolled in Part D, even after accounting for postsale rebates. [ABSTRACT FROM AUTHOR]

Clinical preventive service recommendations from the US Preventive Services Task Force (USPSTF) are based on transparent, systematic, and rigorous methods that consider the certainty of the evidence and magnitude of net benefit. These guidelines aim to address the needs of diverse populations. Biological sex and gender identity are sources of diversity that are not often considered in studies of clinical preventive services that inform the recommendations, resulting in challenges when evaluating the evidence and communicating recommendations for persons in specific gender identification categories (man/woman/gender nonbinary/gender nonconforming/transgender). To advance its methods, the USPSTF reviewed its past recommendations that included the use of sex and gender terms, reviewed the approaches of other guideline-making bodies, and pilot tested strategies to address sex and gender diversity. Based on the findings, the USPSTF intends to use an inclusive approach to identify issues related to sex and gender at the start of the guideline development process; assess the applicability, variability, and quality of evidence as a function of sex and gender; ensure clarity in the use of language regarding sex and gender; and identify evidence gaps related to sex and gender. Evidence reviews will identify the limitations of applying findings to diverse groups from underlying studies that used unclear terminology regarding sex and gender. The USPSTF will use gender-neutral language when appropriate to communicate that recommendations are inclusive of people of any gender and will clearly state when recommendations apply to individuals with specific anatomy associated with biological sex (male/female) or to specific categories of gender identity. The USPSTF recognizes limited evidence to inform the preventive care of populations based on gender identity. [ABSTRACT FROM AUTHOR]

Context: The professional integrity of scientists is important to society as a whole and particularly to disciplines such as medicine that depend heavily on scientific advances for their progress.Objective: To characterize the professional norms of active scientists and compare them with those of individuals with institutional responsibility for the conduct of research.Design: A mailed survey consisting of 12 scenarios in 4 domains of research ethics. Respondents were asked whether an act was unethical and, if so, the degree to which they considered it unethical and to select responses and punishments for the act.Participants: A total of 924 National Science Foundation research grantees in 1993 or 1994 in molecular or cellular biology and 140 representatives from the researchers' institutions to the US Department of Health and Human Services Office of Research Integrity.Main Outcome Measures: Percentage of respondents considering an act unethical and the mean malfeasance rating on a scale of 1 to 10.Results: A total of 606 research grantees and 91 institutional representatives responded to the survey (response rate of 69% of those who could be contacted). Respondents reported a hierarchy of unethical research behaviors. The mean malfeasance rating was unrelated to the characteristics of the investigator performing the hypothetical act or to its consequences. Fabrication, falsification, and plagiarism received malfeasance ratings higher than 8.6, and virtually all thought they were unethical. Deliberately misleading statements about a paper or failure to give proper attribution received ratings between 7 and 8. Sloppiness, oversights, conflicts of interest, and failure to share were less serious still, receiving malfeasance ratings between 5 and 6. Institutional representatives proposed more and different interventions and punishments than the scientists.Conclusions: Surveyed scientists and institutional representatives had strong and similar norms of professional behavior, but differed in their approaches to an unethical act. INSET: Scenario. [ABSTRACT FROM AUTHOR]

Importance: Convalescent plasma is a potential therapeutic option for patients with coronavirus disease 2019 (COVID-19), but further data from randomized clinical trials are needed.Objective: To evaluate the efficacy and adverse effects of convalescent plasma therapy for patients with COVID-19.Design, Setting, and Participants: Open-label, multicenter, randomized clinical trial performed in 7 medical centers in Wuhan, China, from February 14, 2020, to April 1, 2020, with final follow-up April 28, 2020. The trial included 103 participants with laboratory-confirmed COVID-19 that was severe (respiratory distress and/or hypoxemia) or life-threatening (shock, organ failure, or requiring mechanical ventilation). The trial was terminated early after 103 of a planned 200 patients were enrolled.Intervention: Convalescent plasma in addition to standard treatment (n = 52) vs standard treatment alone (control) (n = 51), stratified by disease severity.Main Outcomes and Measures: Primary outcome was time to clinical improvement within 28 days, defined as patient discharged alive or reduction of 2 points on a 6-point disease severity scale (ranging from 1 [discharge] to 6 [death]). Secondary outcomes included 28-day mortality, time to discharge, and the rate of viral polymerase chain reaction (PCR) results turned from positive at baseline to negative at up to 72 hours.Results: Of 103 patients who were randomized (median age, 70 years; 60 [58.3%] male), 101 (98.1%) completed the trial. Clinical improvement occurred within 28 days in 51.9% (27/52) of the convalescent plasma group vs 43.1% (22/51) in the control group (difference, 8.8% [95% CI, -10.4% to 28.0%]; hazard ratio [HR], 1.40 [95% CI, 0.79-2.49]; P = .26). Among those with severe disease, the primary outcome occurred in 91.3% (21/23) of the convalescent plasma group vs 68.2% (15/22) of the control group (HR, 2.15 [95% CI, 1.07-4.32]; P = .03); among those with life-threatening disease the primary outcome occurred in 20.7% (6/29) of the convalescent plasma group vs 24.1% (7/29) of the control group (HR, 0.88 [95% CI, 0.30-2.63]; P = .83) (P for interaction = .17). There was no significant difference in 28-day mortality (15.7% vs 24.0%; OR, 0.59 [95% CI, 0.22-1.59]; P = .30) or time from randomization to discharge (51.0% vs 36.0% discharged by day 28; HR, 1.61 [95% CI, 0.88-2.95]; P = .12). Convalescent plasma treatment was associated with a negative conversion rate of viral PCR at 72 hours in 87.2% of the convalescent plasma group vs 37.5% of the control group (OR, 11.39 [95% CI, 3.91-33.18]; P < .001). Two patients in the convalescent plasma group experienced adverse events within hours after transfusion that improved with supportive care.Conclusion and Relevance: Among patients with severe or life-threatening COVID-19, convalescent plasma therapy added to standard treatment, compared with standard treatment alone, did not result in a statistically significant improvement in time to clinical improvement within 28 days. Interpretation is limited by early termination of the trial, which may have been underpowered to detect a clinically important difference.Trial Registration: Chinese Clinical Trial Registry: ChiCTR2000029757. [ABSTRACT FROM AUTHOR]

Importance: Understanding the profitability of pharmaceutical companies is essential to formulating evidence-based policies to reduce drug costs while maintaining the industry's ability to innovate and provide essential medicines.Objective: To compare the profitability of large pharmaceutical companies with other large companies.Design, Setting, and Participants: This cross-sectional study compared the annual profits of 35 large pharmaceutical companies with 357 companies in the S&P 500 Index from 2000 to 2018 using information from annual financial reports. A statistically significant differential profit margin favoring pharmaceutical companies was evidence of greater profitability.Exposures: Large pharmaceutical vs nonpharmaceutical companies.Main Outcomes and Measures: The main outcomes were revenue and 3 measures of annual profit: gross profit (revenue minus the cost of goods sold); earnings before interest, taxes, depreciation, and amortization (EBITDA; pretax profit from core business activities); and net income, also referred to as earnings (difference between all revenues and expenses). Profit measures are described as cumulative for all companies from 2000 to 2018 or annual profit as a fraction of revenue (margin).Results: From 2000 to 2018, 35 large pharmaceutical companies reported cumulative revenue of $11.5 trillion, gross profit of $8.6 trillion, EBITDA of $3.7 trillion, and net income of $1.9 trillion, while 357 S&P 500 companies reported cumulative revenue of $130.5 trillion, gross profit of $42.1 trillion, EBITDA of $22.8 trillion, and net income of $9.4 trillion. In bivariable regression models, the median annual profit margins of pharmaceutical companies were significantly greater than those of S&P 500 companies (gross profit margin: 76.5% vs 37.4%; difference, 39.1% [95% CI, 32.5%-45.7%]; P < .001; EBITDA margin: 29.4% vs 19%; difference, 10.4% [95% CI, 7.1%-13.7%]; P < .001; net income margin: 13.8% vs 7.7%; difference, 6.1% [95% CI, 2.5%-9.7%]; P < .001). The differences were smaller in regression models controlling for company size and year and when considering only companies reporting research and development expense (gross profit margin: difference, 30.5% [95% CI, 20.9%-40.1%]; P < .001; EBITDA margin: difference, 9.2% [95% CI, 5.2%-13.2%]; P < .001; net income margin: difference, 3.6% [95% CI, 0.011%-7.2%]; P = .05).Conclusions and Relevance: From 2000 to 2018, the profitability of large pharmaceutical companies was significantly greater than other large, public companies, but the difference was less pronounced when considering company size, year, or research and development expense. Data on the profitability of large pharmaceutical companies may be relevant to formulating evidence-based policies to make medicines more affordable. [ABSTRACT FROM AUTHOR]

Importance: The relationship between use of powder in the genital area and ovarian cancer is not established. Positive associations reported in case-control studies have not been confirmed in cohort studies.Objective: To estimate the association between use of powder in the genital area and ovarian cancer using prospective observational data.Design, Setting, and Participants: Data were pooled from 4 large, US-based cohorts: Nurses' Health Study (enrollment 1976; follow-up 1982-2016; n = 81 869), Nurses' Health Study II (enrollment 1989; follow-up 2013-2017; n = 61 261), Sister Study (enrollment 2003-2009; follow-up 2003-2017; n = 40 647), and Women's Health Initiative Observational Study (enrollment 1993-1998; follow-up 1993-2017; n = 73 267).Exposures: Ever, long-term (≥20 years), and frequent (≥1/week) use of powder in the genital area.Main Outcomes and Measures: The primary analysis examined the association between ever use of powder in the genital area and self-reported incident ovarian cancer. Covariate-adjusted hazard ratios (HRs) and 95% CIs were estimated using Cox proportional hazards models.Results: The pooled sample included 252 745 women (median age at baseline, 57 years) with 38% self-reporting use of powder in the genital area. Ten percent reported long-term use, and 22% reported frequent use. During a median of 11.2 years of follow-up (3.8 million person-years at risk), 2168 women developed ovarian cancer (58 cases/100 000 person-years). Ovarian cancer incidence was 61 cases/100 000 person-years among ever users and 55 cases/100 000 person-years among never users (estimated risk difference at age 70 years, 0.09% [95% CI, -0.02% to 0.19%]; estimated HR, 1.08 [95% CI, 0.99 to 1.17]). The estimated HR for frequent vs never use was 1.09 (95% CI, 0.97 to 1.23) and for long-term vs never use, the HR was 1.01 (95% CI, 0.82 to 1.25). Subgroup analyses were conducted for 10 variables; the tests for heterogeneity were not statistically significant for any of these comparisons. While the estimated HR for the association between ever use of powder in the genital area and ovarian cancer risk among women with a patent reproductive tract was 1.13 (95% CI, 1.01 to 1.26), the P value for interaction comparing women with vs without patent reproductive tracts was .15.Conclusions and Relevance: In this analysis of pooled data from women in 4 US cohorts, there was not a statistically significant association between use of powder in the genital area and incident ovarian cancer. However, the study may have been underpowered to identify a small increase in risk. [ABSTRACT FROM AUTHOR]

Importance: Effective prevention strategies for HIV infection are an important public health priority. Preexposure prophylaxis (PrEP) involves use of antiretroviral therapy (ART) daily or before and after sex to decrease risk of acquiring HIV infection.Objective: To synthesize the evidence on the benefits and harms of PrEP, instruments for predicting incident HIV infection, and PrEP adherence to inform the US Preventive Services Task Force.Data Sources: Ovid MEDLINE, the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, and EMBASE through June 2018, with surveillance through January 2019.Study Selection: English-language placebo-controlled randomized clinical trials of oral PrEP with tenofovir disoproxil fumarate/emtricitabine or tenofovir disoproxil fumarate monotherapy; studies on the diagnostic accuracy of instruments for predicting incident HIV infection; and studies on PrEP adherence.Data Extraction and Synthesis: Dual review of titles and abstracts, full-text articles, study quality, and data abstraction. Data were pooled using the Dersimonian and Laird random-effects model for effects of PrEP on HIV infection, mortality, and harms.Main Outcomes and Measures: HIV acquisition, mortality, and harms; adherence to PrEP; and diagnostic test accuracy and discrimination.Results: Fourteen RCTs (N = 18 837), 8 observational studies (N = 3884), and 7 studies of diagnostic accuracy (N = 32 279) were included. PrEP was associated with decreased risk of HIV infection vs placebo or no PrEP after 4 months to 4 years (11 trials; relative risk [RR], 0.46 [95% CI, 0.33-0.66]; I2 = 67%; absolute risk reduction [ARD], -2.0% [95% CI, -2.8% to -1.2%]). Greater adherence was associated with greater efficacy (RR with adherence ≥70%, 0.27 [95% CI, 0.19-0.39]; I2 = 0%) in 6 trials. PrEP was associated with an increased risk of renal adverse events (12 trials; RR, 1.43 [95% CI, 1.18-1.75]; I2 = 0%; ARD, 0.56% [95% CI, 0.09%-1.04%]) and gastrointestinal adverse events (12 trials; RR, 1.63 [95% CI, 1.26-2.11]; I2 = 43%; ARD, 1.95% [95% CI, 0.48%-3.43%]); most adverse events were mild and reversible. Instruments for predicting incident HIV infection had moderate discrimination (area under the receiver operating characteristic curve, 0.49-0.72) and require further validation. Adherence to PrEP in the United States in men who have sex with men varied widely (22%-90%).Conclusions and Relevance: In adults at increased risk of HIV infection, PrEP with oral tenofovir disoproxil fumarate monotherapy or tenofovir disoproxil fumarate/emtricitabine was associated with decreased risk of acquiring HIV infection compared with placebo or no PrEP, although effectiveness decreased with suboptimal adherence. [ABSTRACT FROM AUTHOR]

Importance: Employers have increasingly invested in workplace wellness programs to improve employee health and decrease health care costs. However, there is little experimental evidence on the effects of these programs.Objective: To evaluate a multicomponent workplace wellness program resembling programs offered by US employers.Design, Setting, and Participants: This clustered randomized trial was implemented at 160 worksites from January 2015 through June 2016. Administrative claims and employment data were gathered continuously through June 30, 2016; data from surveys and biometrics were collected from July 1, 2016, through August 31, 2016.Interventions: There were 20 randomly selected treatment worksites (4037 employees) and 140 randomly selected control worksites (28 937 employees, including 20 primary control worksites [4106 employees]). Control worksites received no wellness programming. The program comprised 8 modules focused on nutrition, physical activity, stress reduction, and related topics implemented by registered dietitians at the treatment worksites.Main Outcomes and Measures: Four outcome domains were assessed. Self-reported health and behaviors via surveys (29 outcomes) and clinical measures of health via screenings (10 outcomes) were compared among 20 intervention and 20 primary control sites; health care spending and utilization (38 outcomes) and employment outcomes (3 outcomes) from administrative data were compared among 20 intervention and 140 control sites.Results: Among 32 974 employees (mean [SD] age, 38.6 [15.2] years; 15 272 [45.9%] women), the mean participation rate in surveys and screenings at intervention sites was 36.2% to 44.6% (n = 4037 employees) and at primary control sites was 34.4% to 43.0% (n = 4106 employees) (mean of 1.3 program modules completed). After 18 months, the rates for 2 self-reported outcomes were higher in the intervention group than in the control group: for engaging in regular exercise (69.8% vs 61.9%; adjusted difference, 8.3 percentage points [95% CI, 3.9-12.8]; adjusted P = .03) and for actively managing weight (69.2% vs 54.7%; adjusted difference, 13.6 percentage points [95% CI, 7.1-20.2]; adjusted P = .02). The program had no significant effects on other prespecified outcomes: 27 self-reported health outcomes and behaviors (including self-reported health, sleep quality, and food choices), 10 clinical markers of health (including cholesterol, blood pressure, and body mass index), 38 medical and pharmaceutical spending and utilization measures, and 3 employment outcomes (absenteeism, job tenure, and job performance).Conclusions and Relevance: Among employees of a large US warehouse retail company, a workplace wellness program resulted in significantly greater rates of some positive self-reported health behaviors among those exposed compared with employees who were not exposed, but there were no significant differences in clinical measures of health, health care spending and utilization, and employment outcomes after 18 months. Although limited by incomplete data on some outcomes, these findings may temper expectations about the financial return on investment that wellness programs can deliver in the short term.Trial Registration: ClinicalTrials.gov Identifier: NCT03167658. [ABSTRACT FROM AUTHOR]

Importance: Bundled payments are an increasingly common alternative payment model for Medicare, yet there is limited evidence regarding their effectiveness.Objective: To report interim outcomes from the first year of implementation of a bundled payment model for lower extremity joint replacement (LEJR).Design, Setting, and Participants: As part of a 5-year, mandatory-participation randomized trial by the Centers for Medicare & Medicaid Services, eligible metropolitan statistical areas (MSAs) were randomized to the Comprehensive Care for Joint Replacement (CJR) bundled payment model for LEJR episodes or to a control group. In the first performance year, hospitals received bonus payments if Medicare spending for LEJR episodes was below the target price and hospitals met quality standards. This interim analysis reports first-year data on LEJR episodes starting April 1, 2016, with data collection through December 31, 2016.Exposure: Randomization of MSAs into the CJR bundled payment model group (75 assigned; 67 included) or to the control group without the CJR model (121 assigned; 121 included). Instrumental variable analysis was used to evaluate the relationship between inclusion of MSAs in the CJR model and outcomes.Main Outcomes and Measures: The primary outcome was share of LEJR admissions discharged to institutional postacute care. Secondary outcomes included the number of days in institutional postacute care, discharges to other locations, Medicare spending during the episode (overall and for institutional postacute care), net Medicare spending during the episode, LEJR patient volume and patient case mix, and quality-of-care measures.Results: Among the 196 MSAs and 1633 hospitals, 131 285 eligible LEJR procedures were performed during the study period (mean volume, 110 LEJR episodes per hospital) among 130 343 patients (mean age, 72.5 [SD, 0.91] years; 65% women; 90% white). The mean percentage of LEJR admissions discharged to institutional postacute care was 33.7% (SD, 11.2%) in the control group and was 2.9 percentage points lower (95% CI, -4.95 to -0.90 percentage points) in the CJR group. Mean Medicare spending for institutional postacute care per LEJR episode was $3871 (SD, $1394) in the control group and was $307 lower (95% CI, -$587 to -$27) in the CJR group. Mean overall Medicare spending per LEJR episode was $22 872 (SD, $3619) in the control group and was $453 lower (95% CI, -$909 to $3) in the CJR group, a statistically nonsignificant difference. None of the other secondary outcomes differed significantly between groups.Conclusions and Relevance: In this interim analysis of the first year of the CJR bundled payment model for LEJR among Medicare beneficiaries, MSAs covered by CJR, compared with those that were not, had a significantly lower percentage of discharges to institutional postacute care but no significant difference in total Medicare spending per LEJR episode. Further evaluation is needed as the program is more fully implemented.Trial Registration: ClinicalTrials.gov Identifier: NCT03407885; American Economic Association Registry Identifier: AEARCTR-0002521. [ABSTRACT FROM AUTHOR]

Importance: Use of locum tenens physicians has increased in the United States, but information about their quality and costs of care is lacking.Objective: To evaluate quality and costs of care among hospitalized Medicare beneficiaries treated by locum tenens vs non-locum tenens physicians.Design, Setting, and Participants: A random sample of Medicare fee-for-service beneficiaries hospitalized during 2009-2014 was used to compare quality and costs of hospital care delivered by locum tenens and non-locum tenens internal medicine physicians.Exposures: Treatment by locum tenens general internal medicine physicians.Main Outcomes and Measures: The primary outcome was 30-day mortality. Secondary outcomes included inpatient Medicare Part B spending, length of stay, and 30-day readmissions. Differences between locum tenens and non-locum tenens physicians were estimated using multivariable logistic regression models adjusted for beneficiary clinical and demographic characteristics and hospital fixed effects, which enabled comparisons of clinical outcomes between physicians practicing within the same hospital. In prespecified subgroup analyses, outcomes were reevaluated among hospitals with different levels of intensity of locum tenens physician use.Results: Of 1 818 873 Medicare admissions treated by general internists, 38 475 (2.1%) received care from a locum tenens physician; 9.3% (4123/44 520) of general internists were temporarily covered by a locum tenens physician at some point. Differences in patient characteristics, demographics, comorbidities, and reason for admission between locum tenens and non-locum tenens physicians were not clinically relevant. Treatment by locum tenens physicians, compared with treatment by non-locum tenens physicians (n = 44 520 physicians), was not associated with a significant difference in 30-day mortality (8.83% vs 8.70%; adjusted difference, 0.14%; 95% CI, -0.18% to 0.45%). Patients treated by locum tenens physicians had significantly higher Part B spending ($1836 vs $1712; adjusted difference, $124; 95% CI, $93 to $154), significantly longer mean length of stay (5.64 days vs 5.21 days; adjusted difference, 0.43 days; 95% CI, 0.34 to 0.52), and significantly lower 30-day readmissions (22.80% vs 23.83%; adjusted difference, -1.00%; 95% CI -1.57% to -0.54%).Conclusions and Relevance: Among hospitalized Medicare beneficiaries treated by a general internist, there were no significant differences in overall 30-day mortality rates among patients treated by locum tenens compared with non-locum tenens physicians. Additional research may help determine hospital-level factors associated with the quality and costs of care related to locum tenens physicians. [ABSTRACT FROM AUTHOR]

Importance: The Affordable Care Act expanded Medicaid eligibility for millions of low-income adults. The choice for states to expand Medicaid could affect the financial health of hospitals by decreasing the proportion of patient volume and unreimbursed expenses attributable to uninsured patients while increasing revenue from newly covered patients.Objective: To estimate the association between the Medicaid expansion in 2014 and hospital finances by assessing differences between hospitals in states that expanded Medicaid and in those states that did not expand Medicaid.Design and Setting: Observational study with analysis of data for nonfederal general medical or surgical hospitals in fiscal years 2011 through 2014, using data from the American Hospital Association Annual Survey and the Health Care Cost Report Information System from the US Centers for Medicare & Medicaid Services. Multivariable difference-in-difference regression analyses were used to compare states with Medicaid expansion with states without Medicaid expansion. Hospitals in states that expanded Medicaid eligibility before January 2014 were excluded.Exposures: Medicaid expansion in 2014, accounting for variation in fiscal year start dates.Main Outcomes and Measures: Hospital-reported information on uncompensated care, uncompensated care as a percentage of total hospital expenses, Medicaid revenue, Medicaid as a percentage of total revenue, operating margins, and excess margins.Results: The sample included between 1200 and 1400 hospitals per fiscal year in 19 states with Medicaid expansion and between 2200 and 2400 hospitals per fiscal year in 25 states without Medicaid expansion (with sample size varying depending on the outcome measured). Expansion of Medicaid was associated with a decline of $2.8 million (95% CI, -$4.1 to -$1.6 million; P < .001) in mean annual uncompensated care costs per hospital. Hospitals in states with Medicaid expansion experienced a $3.2 million increase (95% CI, $0.9 to $5.6 million; P = .008) in mean annual Medicaid revenue per hospital, relative to hospitals in states without Medicaid expansion. Medicaid expansion was also significantly associated with improved excess margins (1.1 percentage points [95% CI, 0.1 to 2.0 percentage points]; P = .04), but not improved operating margins (1.1 percentage points [95% CI, -0.1 to 2.3 percentage points]; P = .06).Conclusions and Relevance: The hospitals located in the 19 states that implemented the Medicaid expansion had significantly increased Medicaid revenue, decreased uncompensated care costs, and improvements in profit margins compared with hospitals located in the 25 states that did not expand Medicaid. Further study is needed to assess longer-term implications of this policy change on hospitals' overall finances. [ABSTRACT FROM AUTHOR]

Importance: Critical access hospitals are a predominant source of care for many rural populations. Previous reports suggest these centers provide lower quality of care for common medical admissions. Little is known about the outcomes and costs of patients admitted for surgical procedures.Objective: To compare the surgical outcomes and associated Medicare payments at critical access hospitals vs non-critical access hospitals.Design, Setting, and Participants: Cross-sectional retrospective review of 1,631,904 Medicare beneficiary admissions to critical access hospitals (n = 828) and non-critical access hospitals (n = 3676) for 1 of 4 common types of surgical procedures-appendectomy, 3467 for critical access and 151,867 for non-critical access; cholecystectomy, 10,556 for critical access and 573,435 for non-critical access; colectomy, 10,198 for critical access and 577,680 for non-critical access; hernia repair, 4291 for critical access and 300,410 for non-critical access-between 2009 and 2013. We compared risk-adjusted outcomes using a multivariable logistical regression that adjusted for patient factors (age, sex, race, Elixhauser comorbidities), admission type (elective, urgent, emergency), and type of operation.Exposures: Undergoing surgical procedures at critical access vs non-critical access hospitals.Main Outcomes and Measures: Thirty-day mortality, postoperative serious complications (eg, myocardial infarction, pneumonia, or acute renal failure and a length of stay >75th percentile). Hospital costs were assessed using price-standardized Medicare payments during hospitalization.Results: Patients (mean age, 76.5 years; 56.2% women) undergoing surgery at critical access hospitals were less likely to have chronic medical problems, and they had lower rates of heart failure (7.7% vs 10.7%, P < .0001), diabetes (20.2% vs 21.7%, P < .001), obesity (6.5% vs 10.6%, P < .001), or multiple comorbid diseases (% of patients with ≥2 comorbidities; 60.4% vs 70.2%, P < .001). After adjustment for patient factors, critical access and non-critical access hospitals had no statistically significant differences in 30-day mortality rates (5.4% vs 5.6%; adjusted odds ratio [OR], 0.96; 95% confidence interval [CI], 0.89-1.03; P = .28). However, critical access vs non-critical access hospitals had significantly lower rates of serious complications (6.4% vs 13.9%; OR, 0.35; 95% CI, 0.32-0.39; P < .001). Medicare expenditures adjusted for patient factors and procedure type were lower at critical access hospitals than non-critical access hospitals ($14,450 vs $15,845; difference, -$1395, P < .001).Conclusions and Relevance: Among Medicare beneficiaries undergoing common surgical procedures, patients admitted to critical access hospitals compared with non-critical access hospitals had no significant difference in 30-day mortality rates, decreased risk-adjusted serious complication rates, and lower-adjusted Medicare expenditures, but were less medically complex. [ABSTRACT FROM AUTHOR]

Importance: There is increasing interest in using price transparency tools to decrease health care spending.Objective: To measure the association between offering a health care price transparency tool and outpatient spending.Design, Setting, and Participants: Two large employers represented in multiple market areas across the United States offered an online health care price transparency tool to their employees. One introduced it on April 1, 2011, and the other on January 1, 2012. The tool provided users information about what they would pay out of pocket for services from different physicians, hospitals, or other clinical sites. Using a matched difference-in-differences design, outpatient spending among employees offered the tool (n=148,655) was compared with that among employees from other companies not offered the tool (n=295,983) in the year before and after it was introduced.Exposure: Availability of a price transparency tool.Main Outcomes and Measures: Annual outpatient spending, outpatient out-of-pocket spending, use rates of the tool.Results: Mean outpatient spending among employees offered the tool was $2021 in the year before the tool was introduced and $2233 in the year after. In comparison, among controls, mean outpatient spending changed from $1985 to $2138. After adjusting for demographic and health characteristics, being offered the tool was associated with a mean $59 (95% CI, $25-$93) increase in outpatient spending. Mean outpatient out-of-pocket spending among those offered the tool was $507 in the year before introduction of the tool and $555 in the year after. Among the comparison group, mean outpatient out-of-pocket spending changed from $490 to $520. Being offered the price transparency tool was associated with a mean $18 (95% CI, $12-$25) increase in out-of-pocket spending after adjusting for relevant factors. In the first 12 months, 10% of employees who were offered the tool used it at least once.Conclusions and Relevance: Among employees at 2 large companies, offering a price transparency tool was not associated with lower health care spending. The tool was used by only a small percentage of eligible employees. [ABSTRACT FROM AUTHOR]

Importance: Differences in utilization and costs of end-of-life care among developed countries are of considerable policy interest.Objective: To compare site of death, health care utilization, and hospital expenditures in 7 countries: Belgium, Canada, England, Germany, the Netherlands, Norway, and the United States.Design, Setting, and Participants: Retrospective cohort study using administrative and registry data from 2010. Participants were decedents older than 65 years who died with cancer. Secondary analyses included decedents of any age, decedents older than 65 years with lung cancer, and decedents older than 65 years in the United States and Germany from 2012.Main Outcomes and Measures: Deaths in acute care hospitals, 3 inpatient measures (hospitalizations in acute care hospitals, admissions to intensive care units, and emergency department visits), 1 outpatient measure (chemotherapy episodes), and hospital expenditures paid by insurers (commercial or governmental) during the 180-day and 30-day periods before death. Expenditures were derived from country-specific methods for costing inpatient services.Results: The United States (cohort of decedents aged >65 years, N = 211,816) and the Netherlands (N = 7216) had the lowest proportion of decedents die in acute care hospitals (22.2.% and 29.4%, respectively). A higher proportion of decedents died in acute care hospitals in Belgium (N = 21,054; 51.2%), Canada (N = 20,818; 52.1%), England (N = 97,099; 41.7%), Germany (N = 24,434; 38.3%), and Norway (N = 6636; 44.7%). In the last 180 days of life, 40.3% of US decedents had an intensive care unit admission compared with less than 18% in other reporting nations. In the last 180 days of life, mean per capita hospital expenditures were higher in Canada (US $21,840), Norway (US $19,783), and the United States (US $18,500), intermediate in Germany (US $16,221) and Belgium (US $15,699), and lower in the Netherlands (US $10,936) and England (US $9342). Secondary analyses showed similar results.Conclusions and Relevance: Among patients older than 65 years who died with cancer in 7 developed countries in 2010, end-of-life care was more hospital-centric in Belgium, Canada, England, Germany, and Norway than in the Netherlands or the United States. Hospital expenditures near the end of life were higher in the United States, Norway, and Canada, intermediate in Germany and Belgium, and lower in the Netherlands and England. However, intensive care unit admissions were more than twice as common in the United States as in other countries. [ABSTRACT FROM AUTHOR]

Comments on health care in the United States and on the opinion of the Supreme Court in Pegram versus Herdrich, which proclaimed that health care was a matter of national policy. Background on federal law and physician incentives; Details on the Employee Retirement Income Security Act (ERISA); Why actions taken by the Supreme Court proved to be disappointing.

Objective: The American College of Physicians-American Society of Internal Medicine (ACP-ASIM) End-of-Life Care Consensus Panel was convened in 1997 to identify clinical, ethical, and policy problems in end-of-life care, to analyze critically the available evidence and guidelines, and to offer consensus recommendations on how to improve care of the dying. Topic selection and content presentation were carefully debated to maximize the project's focus on providing practical clinical and other guidance to clinicians who are not specialists in palliative care. This statement examines current legal myths, realities, and grains of truth in end-of-life care.Participants: The Consensus Panel comprises 13 medical and bioethics experts, clinicians, and educators in care at the end of life selected by the Ethics and Human Rights Committee, College leadership, and the Center for Ethics and Professionalism at the ACP-ASIM.Evidence: A literature review including a MEDLINE search of articles from 1970-1998 and review of end-of-life care literature and organizational bibliographies was conducted. Unpublished sources were also identified by participants, as was anecdotal clinical experience.Consensus Process: The draft statement was debated by panel members over a series of 3 to 4 meetings. For this statement, the initial draft and subsequent revised drafts were discussed in 1998-1999. The statement then underwent external peer review and revision before panel approval and the journal peer review process.Conclusions: Legal myths about end-of-life care can undermine good care and ethical medical practice. In addition, at times ethics, clinical judgment, and the law conflict. Patients (or families) and physicians can find themselves considering clinical actions that are ethically appropriate, but raise legal concerns. The 7 major legal myths regarding end-of-life care are: (1) forgoing life-sustaining treatment for patients without decision-making capacity requires evidence that this was the patient's actual wish; (2) withholding or withdrawing of artificial fluids and nutrition from terminally ill or permanently unconscious patients is illegal; (3) risk management personnel must be consulted before life-sustaining medical treatment may be terminated; (4) advance directives must comply with specific forms, are not transferable between states, and govern all future treatment decisions; oral advance directives are unenforceable; (5) if a physician prescribes or administers high doses of medication to relieve pain or other discomfort in a terminally ill patient, resulting in death, he/she will be criminally prosecuted; (6) when a terminally ill patient's suffering is overwhelming despite palliative care, and he/she requests a hastened death, there are no legally permissible options to ease suffering; and (7) the 1997 Supreme Court decisions outlawed physician-assisted suicide. Many legal barriers to end-of-life care are more mythical than real, but sometimes there is a grain of truth. Physicians must know the law of the state in which they practice. JAMA. 2000;284:2495-2501. [ABSTRACT FROM AUTHOR]

Objective: Following an outbreak of measles in 1989-1991, a blueprint for change was developed to improve immunization coverage by addressing deficiencies in the immunization delivery system. A review was undertaken by the National Vaccine Advisory Committee (NVAC) to assess progress in improving immunization coverage, decreasing disease incidence, and developing an immunization delivery system to serve children in the United States. Based on this review, strategies were recommended to sustain success in immunization coverage.Participants: A Subcommittee on Immunization Coverage was appointed by the chairman of the NVAC in 1995 and included representatives from federal agencies, professional organizations, vaccine manufacturers, state and regional health departments, and academic centers.Evidence: Presentations on immunization programs, strategies, and financing were made to the subcommittee by representatives from federal, state, and local agencies; professional organizations; insurers; businesses; and public and private health care providers. Evidence from the published literature also was reviewed.Consensus Process: After review and discussion of evidence presented, conclusions and recommendations were crafted and endorsed by members of the subcommittee. The subcommittee's report was submitted to the NVAC for review, comment, and approval.Conclusions: Although incidence rates of traditional vaccine-preventable diseases are at all-time low levels and corresponding vaccination coverage rates are at all-time high levels, a system to ensure timely vaccination of the 11000 US infants born each day that also incorporates newly recommended vaccines is incomplete. Key barriers include lack of financing of vaccination in many insurance programs and the lack of implementation of evidence-based interventions to raise coverage levels. The NVAC makes 15 recommendations to achieve a sustainable childhood immunization delivery system organized around (1) vaccination financing to ensure full insurance coverage of recommended vaccines and to support the Vaccines for Children program; (2) provider practices to ensure the implementation of recall/reminder systems and office-based assessment of coverage levels; (3) information systems for monitoring disease, vaccination coverage, and performance on immunization delivery; and (4) support for communities and families to ensure that the public is aware of the importance of vaccination, that resources are focused to help underserved children, that immunization linkages with WIC (the Special Supplemental Nutrition Program for Women, Infants, and Children) are enhanced, and that citizen coalitions can advocate improvements in the immunization delivery system. [ABSTRACT FROM AUTHOR]

Context: Increased competitive pressures on academic health centers may result in reduced discretionary funds from patient care revenues to support the performance of unsponsored research, including institutionally funded and faculty-supported activities.Objective: To measure the amount and distribution of unsponsored research activities and their outcomes.Design and Setting: Survey conducted in academic year 1996-1997 of 2336 research faculty in 117 medical schools. Responses were weighted to provide national estimates.Main Outcome Measures: Institutionally funded research as a proportion of total direct costs of research was compared across stages of market competition. Logistic regression was used to assess the relationship of performing unsponsored research to faculty characteristics and market stage.Results: Overall, 43% of faculty received institutional funding for research. Young faculty were more likely than others to receive institutional support (adjusted odds ratio [OR], 1.4; 95% confidence interval [CI], 1.1-1.9; P = .004). The amount of institutional support as a proportion of total funding was more than twice as high in less competitive markets (6.1%) compared with the most competitive markets (2.5%; P = .05). Most faculty (55%) performed faculty-supported research. Clinical researchers (OR, 1.6; 95% CI, 1.1-2.3), principal investigators (OR, 4.3; 95% CI, 2.8-7.0), faculty with high levels of research effort (OR, 6.2; 95% CI, 4.0-9.5) or institutional funding (OR, 1.9; 95% CI, 1.4-2.6), and faculty in the most competitive markets (OR, 1.9; 95% CI, 1.4-2.5) were more likely than others to conduct faculty-supported research. When undertaken by clinical researchers, these activities were supported by clinical income, extra hours worked, and discretionary funds, and often led to publications (76%) or grant awards (51%).Conclusions: Many academic health center faculty receive institutional support to conduct their research or fund the research themselves. Market pressures may be affecting the level of institutional funding available to faculty. [ABSTRACT FROM AUTHOR]

Examines what Americans think about children's health. Survey data and methods; The most serious health problems facing children; What should be done about children without health insurance; The most important government programs for children; Groups that Americans trust for advice on children's health care policies; Other issues.

Context: Concern about transmission of Mycobacterium tuberculosis on college campuses has prompted some schools to institute tuberculin skin test screening of students, but this screening has never been evaluated.Objective: To describe tuberculin skin test screening practices and results of screening in colleges and universities in the United States.Design and Setting: Self-administered mail and telephone questionnaire in November and December 1995 to a stratified random sample of US 2-year and 4-year colleges and universities.Main Outcome Measures: Type of tuberculin screening required; types of schools requiring screening; number and rate of students with positive skin test results and/or diagnosed as having tuberculosis.Results: Of the 3148 US colleges and universities, 624 (78%) of 796 schools surveyed responded. Overall, 378 schools (61%) required tuberculin screening; it was required for all new students (US residents and international students) in 161 (26%) of 624 schools, all new international students but not new US residents in 53 (8%), and students in specific academic programs in 294 (47%). Required screening was more likely in 4-year vs 2-year schools, schools that belonged to the American College Health Association vs nonmember schools, schools with immunization requirements vs schools without, and schools with a student health clinic vs those without (P<.001 for all). Public and private schools were equally likely to require screening (64% vs 62%; P=.21). In the 378 schools with screening requirements, tine or multiple puncture tests were accepted in 95 (25%); test results were recorded in millimeters of induration in 95 (25%); and 100 (27%) reported collecting results in a centralized registry or database. Of the 168 (27%) of 624 schools accepting only Mantoux skin tests and reporting results for school years 1992-1993 through 1995-1996, 3.1% of the 348 368 students screened had positive skin test results (median percentage positive, 0.8%). International students had a significantly higher case rate for active tuberculosis than US residents (35.2 vs 1.1 per 100000 students screened).Conclusions: Widespread tuberculin screening of students yielded a low prevalence of skin test reactors and few tuberculosis cases. To optimize the use of limited public health resources, tuberculin screening should target students at high risk for infection. [ABSTRACT FROM AUTHOR]

Context: With the public's increasing use of complementary and alternative medicine, medical schools must consider the challenge of educating physicians about these therapies.Objectives: To document the prevalence, scope, and diversity of medical school education in complementary and alternative therapy topics and to obtain information about the organizational and academic features of these courses.Design: Mail survey and follow-up letter and telephone survey conducted in 1997-1998.Participants: Academic or curriculum deans and faculty at each of the 125 US medical schools.Main Outcome Measures: Courses taught at US medical schools and administrative and educational characteristics of these courses.Results: Replies were received from 117 (94%) of the 125 US medical schools. Of schools that replied, 75 (64%) reported offering elective courses in complementary or alternative medicine or including these topics in required courses. Of the 123 courses reported, 84 (68%) were stand-alone electives, 38 (31%) were part of required courses, and one (1%) was part of an elective. Thirty-eight courses (31%) were offered by departments of family practice and 14 (11%) by departments of medicine or internal medicine. Educational formats included lectures, practitioner lecture and/or demonstration, and patient presentations. Common topics included chiropractic, acupuncture, homeopathy, herbal therapies, and mind-body techniques.Conclusions: There is tremendous heterogeneity and diversity in content, format, and requirements among courses in complementary and alternative medicine at US medical schools. [ABSTRACT FROM AUTHOR]

Offers commentary on the change in the environment in which academic health centers exist. How the changes affecting health care and higher education in the United States reflect much of what is happening in the rest of society; The effects of the postmodern society on medical institutions; Influence of technological and scientific development; Challenge for academic health centers to develop a effective union between human values and science-based professional competence.