The benefits and costs of U.S. employer COVID-19 vaccine mandates.

In 2021, the Biden Administration issued mandates requiring COVID-19 vaccinations for U.S. federal employees and contractors and for some healthcare and private sector workers. These mandates have been challenged in court; some have been halted or delayed. However, their costs and benefits have not been rigorously appraised. This study helps fill that gap. We estimate the direct costs and health-related benefits that would have accrued if these vaccination requirements had been implemented as intended. Compared with the January 2022 vaccination rates, we find that the mandates could have led to 15 million additional vaccinated individuals, increasing the overall proportion of the fully vaccinated U.S. population from 64% to 68%. The associated net benefits depend on the subsequent evolution of the pandemic-information unavailable ex ante to analysts or policymakers. In scenarios involving the emergence of a novel, more transmissible variant, against which vaccination and previous infection offer moderate protection, the estimated net benefits are potentially large. They reach almost $20,000 per additional vaccinated individual, with more than 20,000 total deaths averted over the 6-month period assessed. In scenarios involving a fading pandemic, existing vaccination-acquired or infection-acquired immunity provides sufficient protection, and the mandates' benefits are unlikely to exceed their costs. Thus, mandates may be most useful when the consequences of inaction are catastrophic. However, we do not compare the effects of mandates with alternative policies for increasing vaccination rates or for promoting other protective measures, which may receive stronger public support and be less likely to be overturned by litigation.

Burden, timing, and relationship of cardiovascular hospitalization to mortality among Medicare beneficiaries with newly diagnosed atrial fibrillation.

BACKGROUND: Limited data exist on the burden and relationship of cardiovascular (CV) hospitalization to mortality after newly diagnosed with atrial fibrillation (AF). METHODS: Using a 20% sample of nationwide Medicare Part A and B claims data, we performed a retrospective cohort study of Medicare beneficiaries with newly diagnosed AF (2004-2008). Cox proportional hazards time-varying exposures were used to determine the risk of death among patients with CV hospitalization after AF diagnosis. RESULTS: Of 228,295 patients (mean age 79.6 ± 7.4 years, 56% female), 57% had a CV hospitalization after diagnosis of AF (41% in the first year). The most common primary CV hospitalization diagnoses were AF/supraventricular arrhythmias (21%), heart failure (19%), myocardial infarction (11%), and stroke/transient ischemic attack (7.7%). Incidence rates per 1,000 person-years among patients with and without CV hospitalization were 114 and 87, respectively, for all-cause mortality. After adjustment for covariates and time to CV hospitalization, the hazard of mortality among newly diagnosed AF patients with CV hospitalization, compared with those without CV hospitalization, was higher (hazard ratio 1.22, 95% CI 1.20-1.24). CONCLUSIONS: Cardiovascular hospitalization is common in the first year after AF diagnosis. Atrial fibrillation, heart failure, myocardial infarction, and stroke/transient ischemic attack account for half of primary hospitalization diagnosis. Cardiovascular hospitalization is independently associated with mortality, irrespective of time from diagnosis to first hospitalization, and represents a critical inflection point in survival trajectory. These findings highlight the importance of CV hospitalization as a marker of disease progression and poor outcomes. Efforts to clarify the determinants of hospitalization could inform interventions to reduce admissions and improve survival.

The Disability burden of COPD.

Affecting an estimated 12.6 million people and causing over 100,000 deaths per year, chronic obstructive pulmonary disease (COPD) exacts a heavy burden on American society. Despite knowledge of the impact of COPD on morbidity, mortality, and health care costs, little is known about the association of the disease with economic outcomes such as employment and the collection of disability. We quantify the impact of COPD on Americans aged 51 and older-in particular, their employment prospects and their likelihood of collecting federal disability benefits-by conducting longitudinal regression analysis using the Health and Retirement Study. Controlling for initial health status and a variety of sociodemographic factors, we find that COPD is associated with a decrease in the likelihood of employment of 8.6 percentage points (OR = 0.58, 95% CI 0.50-0.67), from 44% to 35%. This association rivals that of stroke and is larger than those of heart disease, cancer, hypertension, and diabetes. Furthermore, COPD is associated with a 3.9 percentage point (OR 2.52, 95% CI 2.00-3.17) increase in the likelihood of collecting Social Security Disability Insurance (SSDI), from 3.2% to 7.1%, as well as a 1.7 percentage point (OR 2.87, 95% CI 2.02-4.08) increase in the likelihood of collecting Supplemental Security Income (SSI), from 1.0% to 2.7%. The associations of COPD with SSDI and SSI are the largest of any of the conditions studied. Our results are consistent with the hypothesis that COPD imposes a substantial burden on American society by inhibiting employment and creating disability.

Valuing COVID-19 Morbidity Risk Reductions.

Many economic analyses, including those that address the COVID-19 pandemic, focus on the value of averting deaths and do not include the value of averting nonfatal illnesses. Yet incorporating the value of averting nonfatal cases may change conclusions about the desirability of the policy. While per case values may be small, the number of nonfatal cases is often large, far outstripping the number of fatal cases. The value of averting nonfatal cases is also increasingly important in evaluating COVID-19 policy options as vaccine- and infection-related immunity and treatments reduce the case-fatality rate. Unfortunately, little valuation research is available that explicitly addresses COVID-19 morbidity. We describe and implement an approach for approximating the value of averting nonfatal illnesses or injuries and apply it to COVID-19 in the United States. We estimate gains from averting COVID-19 morbidity of about 0.01 quality-adjusted life year (QALY) per mild case averted, 0.02 QALY per severe case, and 3.15 QALYs per critical case. These gains translate into monetary values of about $5,300 per mild case, $11,000 per severe case, and $1.8 million per critical case. While these estimates are imprecise, they suggest the magnitude of the effects.

The Modest Effects of Fact Boxes on Cancer Screening.

As health care becomes increasingly personalized to the needs and values of individual patients, informational interventions that aim to inform and debias consumer decision-making are likely to become important tools. In a randomized controlled experiment, we explore the effects of providing participants with published fact boxes on the benefits and harms of common cancer screening procedures. Female participants were surveyed about breast cancer screening by mammography, while male participants were surveyed about prostate cancer screening by prostate-specific antigen (PSA) testing. For these screening procedures, we expect consumers to have overly optimistic prior beliefs about the benefits and harms. We find that participants update their beliefs about the net benefits of screening modestly, but we observe little change in their stated preferences to seek screening. Participants who scored higher on a numeracy test updated their beliefs about screening benefits more in response to the fact boxes than did participants who scored lower on the numeracy test.

Clinical evidence inputs to comparative effectiveness research could impact the development of novel treatments.

AIM: This study aims to analyze the impacts of a range of clinical evidence generation scenarios associated with comparative effectiveness research (CER) on pharmaceutical innovation. MATERIALS & METHODS: We used the Global Pharmaceutical Policy Model to project the effect of changes in pharmaceutical producer costs, revenues and timings on drug innovation and health for the age 55+ populations in the USA and Europe through year 2060 using three clinical scenarios. RESULTS: Changes in producer incentives from widespread CER evidence generation and use had varied but often large predicted impacts on simulated outcomes in 2060. Effect on the number of new drug introductions ranged from a 81.1% reduction to a 45.5% increase, and the effect on population-level life expectancy ranged from a 15.6% reduction to a 11.4% increase compared to baseline estimates. CONCLUSION: The uncertainty surrounding the consequences of increased clinical evidence generation and use on innovation calls for a carefully measured approach to CER implementation, balancing near-term benefits to spending and health with long-term implications for innovation.

Trends in resistance to carbapenems and third-generation cephalosporins among clinical isolates of Klebsiella pneumoniae in the United States, 1999-2010.

OBJECTIVE: Multidrug-resistant Enterobacteriaceae pose a serious infection control challenge and have emerged as a public health threat. We examined national trends in the proportion of Klebsiella pneumoniae isolates resistant to carbapenems (CRKP) and third-generation cephalosporins (G3CRKP). DESIGN AND SETTING: Retrospective analysis of approximately 500,000 K. pneumoniae isolates cultured between January 1999 and July 2010 at 287 clinical laboratories throughout the United States. METHODS: Isolates were defined as CRKP if they were nonsusceptible to 1 or more carbapenems and were defined as G3CRKP if they were nonsusceptible to ceftazidime, ceftriaxone, or related antibiotics. A multivariable analysis examined trends in the proportion of resistant isolates, adjusting for age, sex, isolate source, patient location, and geographic region. RESULTS: The crude proportion of CRKP increased from less than 0.1% to 4.5% between 2002 and 2010; the frequency of G3CRKP increased from 5.3% to 11.5% between 1999 and 2010. G3CRKP and CRKP were more common among elderly patients (those greater than 65 years of age); the adjusted odds ratio (aOR) relative to pediatric patients (those less than 18 years of age) was 1.2 for G3CRKP (95% confidence interval [CI], 1.2-1.3) and 3.3 for CRKP (95% CI, 2.6-4.2). G3CRKP and CRKP were also more common among patients from the northeastern United States (aOR, 2.9 [95% CI, 2.8-3.0] and 9.0 [95% CI, 7.9-10.4]) than among those from the western United States. The prevalence of outpatient CRKP isolates increased after 2006, reaching 1.9% of isolates in our sample in 2010 (95% CI, 1.6%-2.1%). CONCLUSIONS: The frequency of G3CRKP and CRKP is increasing in all regions of the United States, and resistance is emerging among isolates recovered in the outpatient setting. This underscores the need for enhanced laboratory capacity and coordinated surveillance strategies to contain the further spread of these emerging pathogens.

Optimizing antimicrobial prescribing: Are clinicians following national trends in methicillin-resistant staphylococcus aureus (MRSA) infections rather than local data when treating MRSA wound infections.

BACKGROUND: Clinicians often prescribe antimicrobials for outpatient wound infections before culture results are known. Local or national MRSA rates may be considered when prescribing antimicrobials. If clinicians prescribe in response to national rather than local MRSA trends, prescribing may be improved by making local data accessible. We aimed to assess the correlation between outpatient trends in antimicrobial prescribing and the prevalence of MRSA wound infections across local and national levels. METHODS: Monthly MRSA positive wound culture counts were obtained from The Surveillance Network, a database of antimicrobial susceptibilities from clinical laboratories across 278 zip codes from 1999-2007. Monthly outpatient retail sales of linezolid, clindamycin, trimethoprim-sulfamethoxazole and cephalexin from 1999-2007 were obtained from the IMS Health XponentTM database. Rates were created using census populations. The proportion of variance in prescribing that could be explained by MRSA rates was assessed by the coefficient of determination (R2), using population weighted linear regression. RESULTS: 107,215 MRSA positive wound cultures and 106,641,604 antimicrobial prescriptions were assessed. The R2 was low when zip code-level antimicrobial prescription rates were compared to MRSA rates at all levels. State-level prescriptions of clindamycin and linezolid were not correlated with state MRSA rates. The variance in state-level prescribing of clindamycin and linezolid was correlated with national MRSA rates (clindamycin R2 = 0.17, linezolid R2 = 0.22). CONCLUSIONS: Clinicians may rely on national, not local MRSA data when prescribing clindamycin and linezolid for wound infections. Providing local resistance data to prescribing clinicians may improve antimicrobial prescribing and would be a possible target for future interventions.

Cost-sharing and initiation of disease-modifying therapy for multiple sclerosis.

OBJECTIVES: To assess the effects of patient cost sharing on initiation of disease-modifying therapies (DMTs) in multiple sclerosis (MS). STUDY DESIGN: Retrospective claims database study of privately insured patients newly diagnosed with MS between 2004 and 2008 from 33 large employers. METHODS: We assessed the effects of plan-level cost-sharing on DMT initiation during a 2-year follow-up period after diagnosis. Incident cases were identified by 2 or more claims with ICD-9 codes for MS within a year, subsequent to a year with no such claims. Covariates for adjustment included age, gender, relationship to primary beneficiary, comorbid conditions, and calendar year, as well as unobserved factors that did not vary within plans over time. RESULTS: Out of a sample of 3460 patients meeting criteria for inclusion, only 17% initiated a DMT within 2 years of diagnosis. An increase in the cost-sharing rate from zero to the 95th percentile (17.8%) was predicted to decrease initiation within 2 years of diagnosis by 2.9 percentage points, or 12.7% (P = .019). CONCLUSIONS: High cost-sharing is associated with delayed initiation of effective MS therapies.

An analysis of whether higher health care spending in the United States versus Europe is 'worth it' in the case of cancer.

The United States spends more on health care than other developed countries, but some argue that US patients do not derive sufficient benefit from this extra spending. We studied whether higher US cancer care costs, compared with those of ten European countries, were "worth it" by looking at the survival differences for cancer patients in these countries compared to the relative costs of cancer care. We found that US cancer patients experienced greater survival gains than their European counterparts; even after considering higher US costs, this investment generated $598 billion of additional value for US patients who were diagnosed with cancer between 1983 and 1999. The value of that additional survival gain was highest for prostate cancer patients ($627 billion) and breast cancer patients ($173 billion). These findings do not appear to have been driven solely by earlier diagnosis. Our study suggests that the higher-cost US system of cancer care delivery may be worth it, although further research is required to determine what specific tools or treatments are driving improved cancer survival in the United States.

The large social value resulting from use of statins warrants steps to improve adherence and broaden treatment.

Statins are considered a clinically important breakthrough for the treatment of cardiovascular disease. However, their social value at the US population level has not previously been studied. From an economic perspective, social value measures the quantity of resources--in monetary terms--that society would be willing to give up in order to retain the survival gains resulting from statin therapy. Using combined population and clinical data, this article calculates statins' social value to consumers, or the value of survival benefits above actual payments for the drug, and to producers, or drug revenues, for the period 1987-2008. National survey data suggest that statin therapy reduced low-density lipoprotein levels by 18.8 percent, which translated into roughly 40,000 fewer deaths, 60,000 fewer hospitalizations for heart attacks, and 22,000 fewer hospitalizations for strokes in 2008. For people starting statin therapy in 1987-2008, consumers captured $947.4 billion (76 percent) of the total social value of the survival gains. Even greater consumer benefits could be achieved in the future if statins were prescribed in full compliance with cholesterol guidelines and patients adhered to prescribed regimens. In addition, statin costs are declining because of patent expirations. Policy makers should consider interventions at the patient and provider levels to encourage both therapy for untreated patients with high cholesterol and greater adherence after therapy is initiated.

Seasonal and temperature-associated increases in gram-negative bacterial bloodstream infections among hospitalized patients.

BACKGROUND: Knowledge of seasonal trends in hospital-associated infection incidence may improve surveillance and help guide the design and evaluation of infection prevention interventions. We estimated seasonal variation in the frequencies of inpatient bloodstream infections (BSIs) caused by common bacterial pathogens and examined associations of monthly BSI frequencies with ambient outdoor temperature, precipitation, and humidity levels. METHODS: A database containing blood cultures from 132 U.S. hospitals collected between January 1999 and September 2006 was assembled. The database included monthly counts of inpatient blood cultures positive for several clinically important Gram-negative bacteria (Acinetobacter spp, Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa) and Gram-positive bacteria (Enterococcus spp and Staphylococcus aureus). Monthly mean temperature, total precipitation, and mean relative humidity in the postal ZIP codes of participating hospitals were obtained from national meteorological databases. RESULTS: A total of 211,697 inpatient BSIs were reported during 9,423 hospital-months. Adjusting for long-term trends, BSIs caused by each gram-negative organism examined were more frequent in summer months compared with winter months, with increases ranging from 12.2% for E. coli (95% CI 9.2-15.4) to 51.8% for Acinetobacter (95% CI 41.1-63.2). Summer season was associated with 8.7% fewer Enterococcus BSIs (95% CI 11.0-5.8) and no significant change in S. aureus BSI frequency relative to winter. Independent of season, monthly humidity, monthly precipitation, and long-term trends, each 5.6°C (10°F) rise in mean monthly temperature corresponded to increases in gram-negative bacterial BSI frequencies ranging between 3.5% for E. coli (95% CI 2.1-4.9) to 10.8% for Acinetobacter (95% CI 6.9-14.7). The same rise in mean monthly temperature corresponded to an increase of 2.2% in S. aureus BSI frequency (95% CI 1.3-3.2) but no significant change in Enterococcus BSI frequency. CONCLUSIONS: Summer season and higher mean monthly outdoor temperature are associated with substantially increased frequency of BSIs, particularly among clinically important gram-negative bacteria.

Validity of ICD-9-CM coding for identifying incident methicillin-resistant Staphylococcus aureus (MRSA) infections: is MRSA infection coded as a chronic disease?

BACKGROUND AND OBJECTIVE: Investigators and medical decision makers frequently rely on administrative databases to assess methicillin-resistant Staphylococcus aureus (MRSA) infection rates and outcomes. The validity of this approach remains unclear. We sought to assess the validity of the International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) code for infection with drug-resistant microorganisms (V09) for identifying culture-proven MRSA infection. DESIGN: Retrospective cohort study. METHODS: All adults admitted to 3 geographically distinct hospitals between January 1, 2001, and December 31, 2007, were assessed for presence of incident MRSA infection, defined as an MRSA-positive clinical culture obtained during the index hospitalization, and presence of the V09 ICD-9-CM code. The κ statistic was calculated to measure the agreement between presence of MRSA infection and assignment of the V09 code. Sensitivities, specificities, positive predictive values, and negative predictive values were calculated. RESULTS: There were 466,819 patients discharged during the study period. Of the 4,506 discharged patients (1.0%) who had the V09 code assigned, 31% had an incident MRSA infection, 20% had prior history of MRSA colonization or infection but did not have an incident MRSA infection, and 49% had no record of MRSA infection during the index hospitalization or the previous hospitalization. The V09 code identified MRSA infection with a sensitivity of 24% (range, 21%-34%) and positive predictive value of 31% (range, 22%-53%). The agreement between assignment of the V09 code and presence of MRSA infection had a κ coefficient of 0.26 (95% confidence interval, 0.25-0.27). CONCLUSIONS: In its current state, the ICD-9-CM code V09 is not an accurate predictor of MRSA infection and should not be used to measure rates of MRSA infection.

Clinical and economic outcomes attributable to health care-associated sepsis and pneumonia.

BACKGROUND: Health care-associated infections affect 1.7 million hospitalizations each year, but the clinical and economic costs attributable to these infections are poorly understood. Reliable estimates of these costs are needed to efficiently target limited resources for the greatest public health benefit. METHODS: Hospital discharge records from the Nationwide Inpatient Sample database were used to identify sepsis and pneumonia cases among 69 million discharges from hospitals in 40 US states between 1998 and 2006. Community-acquired infections were excluded using criteria adapted from previous studies. Because these criteria may not exclude all community-acquired infections, outcomes were examined separately for cases associated with invasive procedures, which were unlikely to result from preexisting infections. Attributable hospital length of stay, hospital costs, and crude in-hospital mortality were estimated from discharge records using a multivariate matching analysis and a supplementary regression analysis. These models controlled for patient diagnoses, procedures, comorbidities, demographics, and length of stay before infection. RESULTS: In cases associated with invasive surgery, attributable mean length of stay was 10.9 days, costs were $32 900, and mortality was 19.5% for sepsis; corresponding values for pneumonia were 14.0 days, $46 400, and 11.4%, respectively (P < .001). In cases not associated with invasive surgery, attributable mean length of stay, costs, and mortality were estimated to be 1.9 to 6.0 days, $5800 to $12 700, and 11.7% to 16.0% for sepsis and 3.7 to 9.7 days, $11 100 to $22 300, and 4.6% to 10.3% for pneumonia (P < .001). CONCLUSION: Health care-associated sepsis and pneumonia impose substantial clinical and economic costs.