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Ethel S Siris,1 Jingbo Yu,2 Katalin Bognar,3 Mitch DeKoven,4 Anshu Shrestha,3 John A Romley,5 Ankita Modi2 1Toni Stabile Osteoporosis Center, Columbia University Medical Center, NY Presbyterian Hospital, New York, NY, 2Merck & Co., Inc., Kenilworth, NJ, 3Precision Health Economics, Los Angeles, CA, 4Real-World Evidence Solutions, IMS Health, Fairfax, VA, 5Leonard D. Schaeffer Center for Health Policy and Economics, University of Southern California, Los Angeles, CA, USA Objectives: To examine the rate of osteoporosis (OP) undertreatment and the association between gastrointestinal (GI) events and OP treatment initiation among elderly osteoporotic women with Medicare Part D drug coverage.Methods: This retrospective cohort study utilized a 20% random sample of Medicare beneficiaries. Included were women ≥66 years old with Medicare Part D drug coverage, newly diagnosed with OP in 2007–2008 (first diagnosis date as the index date), and with no prior OP treatment. GI event was defined as a diagnosis or procedure for a GI condition between OP diagnosis and treatment initiation or at the end of a 12-month follow-up, whichever occurred first. OP treatment initiation was defined as the use of any bisphosphonate (BIS) or non-BIS within 1 year postindex. Logistic regression, adjusted for patient characteristics, was used to model the association between 1) GI events and OP treatment initiation (treated versus nontreated); and 2) GI events and type of initial therapy (BIS versus non-BIS) among treated patients only.Results: A total of 126,188 women met the inclusion criteria: 72.1% did not receive OP medication within 1 year of diagnosis and 27.9% had GI events. Patients with a GI event were 75.7% less likely to start OP treatment (odds ratio [OR]=0.243; P

Introduction: Previous observational studies assessing β2-agonist/-antagonist use on PD risk have yielded conflicting results. We evaluated the relationship between β2-agonist use and the incidence of Parkinson's disease in patients with chronic lung disease., Methods: We performed a retrospective cohort analysis on a 20% random sample abstracted from a traditional (fee-for-service) Medicare program in the United States. Inclusion criteria were individuals over 65 years old diagnosed with asthma, COPD, and/or bronchiectasis who were enrolled in a prescription drug (standalone Part D) plan over 2007-2010 and alive through 2014. The main outcome measure was a diagnosis of Parkinson's disease over the period 2011-2014, in relation to the number of 30-day-equivalent drug claims over 2007-2010. Logistic regression analysis was performed on a sample including 236,201 Medicare beneficiaries., Results: The sample was 68% female, 80% white, and on average 77 years old as of 2010. Compared to non-users, β2-agonist users were more likely to be younger (76.3y versus 78.0y), smokers (40.4% versus 31.1%) and asthmatic (62.4% versus 28.3%). The odds ratio for a β2-agonist claim on PD development was 0.986 (95% CI 0.977-0.995) after adjusting for demographics, smoking history, respiratory exacerbations, comorbidities, and other drug use. Risk reductions were larger for males than females (0.974 versus 0.994, P = 0.032), and for individuals with COPD compared to those with asthma (0.968 versus 0.998, P = 0.049). Reverse causality was addressed with a Cox analysis that allowed β2-agonist use to vary from medication initiation to disease onset. By the end of the follow-up period, β2-agonist use was shown to be associated with a true protective effect against PD onset., Discussion: β2-agonist use is associated with decreased risk of PD incidence. Further investigation, possibly including clinical trials, is warranted to strengthen the evidence base supporting clinical decision-makers looking to repurpose pharmaceuticals to prevent neurodegenerative disease onset., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: During the past three years, Dana Goldman (DG) has received research support, speaker fees, travel assistance, or consulting income from the following sources: Amgen, Blue Cross Blue Shield of Arizona, Bristol Myers Squibb, Cedars-Sinai Health System, Edwards Lifesciences, Gates Ventures, Genentech, Gilead Sciences, Johnson & Johnson, Kaiser Family Foundation, National Institutes of Health, Novartis, Pfizer, Roche, and Walgreens Boots Alliance. DG holds equity in EntityRisk. DG reports personal fees from Biogen and GRAIL as a scientific advisor. Until November 2019, DG served on the Scientific Advisory Board of ACADIA Pharmaceuticals. Until March 2020, DG served as a scientific advisor to Precision Medicine Group. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2022 Nadeem et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objectives: This study documents trends in risk-adjusted quality and cost for a variety of inpatient surgical procedures among Medicare beneficiaries from 2002 through 2015, which can provide valuable insight on future strategies to improve public health and health care., Methods: We focused on 11 classes of inpatient surgery, defined by the Agency for Health Research and Quality's (AHRQ's) Clinical Classification System. The surgical classes studied included a wide range of surgeries, including tracheostomy, heart valve procedures, colorectal resection, and wound debridement, among others. For each surgical class, we assessed trends in treatment costs and quality outcomes, as defined by 30-day survival without unplanned readmissions, among Medicare beneficiaries receiving these procedures during hospital stays. Quality and costs were adjusted for patient severity based on demographics, comorbidities, and community context. We also explored surgical innovations of these 11 classes of inpatient surgery from 2002-2015., Results: We found significant improvements in quality for 7 surgical classes, ranging from 0.08% (percutaneous transluminal coronary angioplasty) to 0.74% (heart valve procedures) per year. Changes in cost varied by surgery, the significant decrease in cost ranged from -2.59% (tracheostomy) to -0.34% (colorectal resection) per year. Treatment innovation occurred with respect to surgical procedures utilized for heart valve procedures and colorectal resection, which may be associated with the decrease in surgical cost., Conclusions: Our results suggest that there was significant quality improvement for 7 surgery categories over the 14-year study period. Costs decreased significantly for 6 surgery categories, and increased significantly for 3 other categories., Competing Interests: The authors have declared that no competing interests exist.

The objective of this study was to examine the association between surgeon characteristics, procedural volume, and short-term outcomes of hemodialysis vascular access. A retrospective cohort study was performed using Medicare Part A and B data from 2007 through 2014 merged with American Medical Association Physician Masterfile surgeon data. A total of 29,034 procedures met the inclusion criteria: 22,541 (78%) arteriovenous fistula (AVF) and 6,493 (22%) arteriovenous graft (AVG). Of these, 13,110 (45.2%) were performed by vascular surgeons, 9,398 (32.3%) by general surgeons, 2,313 (8%) by thoracic surgeons, 1,517 (5.2%) by other specialties, and 2,696 (9.3%) were unknown. Every 10-year increase in years in practice was associated with a 6.9 per cent decrease in the odds of creating AVF versus AVG ( P = 0.02). Surgeon characteristics were not associated with the likelihood of vascular access failure. Every 10-procedure increase in cumulative procedure volume was associated with a 5 per cent decrease in the odds of vascular access failure ( P = 0.007). There was no association of provider characteristics or procedure volume with survival free of repeat AVF/AVG or TC placement at 12 months. A significant portion of the variability in likelihood of creating AVF versus AVG is attributable to the provider-level variation. Increase in procedure volume is associated with decreased odds of vascular access failure.

Background: Health care is believed to be suffered from a "cost disease," in which a heavy reliance on labor limits opportunities for efficiencies stemming from technological improvement. Although recent evidence shows that U.S. hospitals have experienced a positive trend of productivity growth, skilled nursing facilities are relatively "low-tech" compared to hospitals, leading some to worry that productivity at skilled nursing facilities will lag behind the rest of the economy., Objective: To assess productivity growth among skilled nursing facilities (SNFs) in the treatment of conditions which frequently involve substantial post-acute care after hospital discharge., Methods: We constructed an analytic file with the records of Medicare beneficiaries that were discharged from acute-care hospitals to SNFs with stroke, hip fracture, or lower extremity joint replacement (LEJR) between 2006 and 2014. We populated each record for 90 days starting at the time of SNF admission, detailing for each day the treatment site and all associated costs. We used ordinary least square regression to estimate growth in SNF productivity, measured by the ratio of "high-quality SNF stays" to total treatment costs. The primary definition of a high-quality stay was a stay that ended with the return of the patient to the community within 90 days after SNF admission. We controlled for patient demographics and comorbidities in the regression analyses., Results: Our sample included 1,076,066 patient stays at 14,394 SNFs with LEJR, 315,546 patient stays at 14,154 SNFs with stroke, and 739,608 patient stays at 14,588 SNFs with hip fracture. SNFs improved their productivity in the treatment of patients with LEJR, stroke, and hip fracture by 1.1%, 2.2%, and 2.0% per year, respectively. That pattern was robust to a number of alternative specifications. Regressions on year dummies showed that the productivity first decreased and then increased, with a lowest point in 2011. Over the study period, quality continued to rise, but dominated by higher costs at first. Costs then started to decrease, driving productivity to grow., Conclusion: There has been substantial productivity growth in recent years among SNFs in the U.S. in the treatment of post-acute-care-intensive conditions., Competing Interests: The authors have declared that no competing interests exist.

Objectives: To measure value in the delivery of inpatient care and to quantify its variation across U.S. regions., Data Sources / Study Setting: A random (20%) sample of 33,713 elderly fee-for-service Medicare beneficiaries treated in 2,232 hospitals for a heart attack in 2013., Study Design: We estimate a production function for inpatient care, defining output as stays with favorable patient outcomes in terms of survival and readmission. The regression model includes hospital inputs measured by treatment costs, as well as patient characteristics. Region-level effects in the production function are used to estimate the productivity and value of the care delivered by hospitals within regions., Data Collection / Extraction Methods: Medicare claims and enrollment files, linked to the Dartmouth Atlas of Health Care and Inpatient Prospective Payment System Impact Files., Principal Findings: Hospitals in the hospital referral region at the 90th percentile of the value distribution delivered 54% more high-quality stays than hospitals at the 10th percentile could have delivered, after adjusting for treatment costs and patient severity., Conclusions: Variation in the delivery of high-value inpatient care points to opportunities for better quality and lower costs., Competing Interests: The authors have declared that no competing interests exist.

Objectives: To model the impacts of restrictive formulary designs on outcomes for patients with HIV and to demonstrate the costs of restricting access to novel HIV regimens with better safety and efficacy profiles., Study Design: We modified an epidemiological model of HIV incidence, progression, and treatment to simulate the effects of 5 formulary scenarios on patient outcomes in the United States., Methods: Using a cohort of HIV-susceptible individuals, we followed patients through HIV infection, disease progression, and death. Patients transitioned in and out of treatment states once infected. Treatment discontinuation, efficacy, and the rate of adverse events (AEs; renal failure and bone fracture) in each formulary scenario depended on the treatment path and regimens included. Outcomes of interest included all-cause cumulative deaths, annual rates of AEs, and costs associated with treating those AEs., Results: All outcomes of interest were more favorable in less restrictive formulary scenarios that provided fewer barriers to appropriate treatments. By 2025, more restrictive formularies would have resulted in 171,500 more cumulative bone and renal events among treated patients with HIV compared with an open formulary. This corresponds to AE treatment costs of $3.65 billion in more restrictive formularies compared with $1.43 billion in an open formulary. Finally, compared with an open formulary, there would be an additional 16,200 cumulative deaths in more restrictive formularies., Conclusions: Less restrictive formulary designs, which allow patients with HIV to initiate potentially safer and more efficacious regimens based on their proclivity to AEs, yield better outcomes and reduce costs.

Background: Previous research has found that patients with acute cardiovascular conditions treated in teaching hospitals have lower 30-day mortality during dates of national cardiology meetings., Methods and Results: We analyzed 30-day mortality among Medicare beneficiaries hospitalized with acute myocardial infarction (overall, ST-segment-elevation myocardial infarction, and non-ST-segment-elevation myocardial infarction) from January 1, 2007, to November 31, 2012, in major teaching hospitals during dates of a major annual interventional cardiology meeting (Transcatheter Cardiovascular Therapeutics) compared with identical nonmeeting days in the ±5 weeks. Treatment differences were assessed. We used a database of US physicians to compare interventional cardiologists who practiced and did not practice during meeting dates ("stayers" and "attendees," respectively) in terms of demographic characteristics and clinical and research productivity. Unadjusted and adjusted 30-day mortality rates were lower among patients admitted during meeting versus nonmeeting dates (unadjusted, 15.3% [482/3153] versus 16.7% [5208/31 556] [ P =0.04]; adjusted, 15.4% versus 16.7%; difference -1.3% [95% confidence interval, -2.7% to -0.1%] [ P =0.05]). Rates of interventional cardiologist involvement were similar between dates (59.5% versus 59.8% of hospitalizations; P =0.88), as were percutaneous coronary intervention rates (30.2% versus 29.1%; P =0.20). Mortality reductions were largest among patients with non-ST-segment-elevation myocardial infarction not receiving percutaneous coronary intervention (16.9% versus 19.5% adjusted 30-day mortality; P =0.008). Compared with stayers, attendees were of similar age and sex, but had greater publications (18.9 versus 6.3; P <0.001), probability of National Institutes of Health funding (5.3% versus 0.4%; P <0.001), and clinical trial leadership (10.3% versus 3.9%; P <0.001), and they performed more percutaneous coronary interventions annually (85.6 versus 63.3; P <0.001)., Conclusions: Hospitalization with acute myocardial infarction during Transcatheter Cardiovascular Therapeutics meeting dates was associated with lower 30-day mortality, predominantly among patients with non-ST-segment-elevation myocardial infarction who were medically managed., (© 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)

When a pharmaceutical manufacturer experiences a safety problem, negative impacts on profitability can spread to its competitors. Reduced consumer confidence, product recalls, and litigation are limited to the responsible manufacturer only if that manufacturer can be clearly linked to the safety problem. We analyze the impact of "accountability" for safety problems on manufacturer entry decisions and investments to mitigate risk. Consistent with prior research, we find investment levels increase with accountability in a duopoly market, and that accountability can thus enhance market viability and improve consumer welfare. However, we also analyze the impact of accountability on entry of a competitor, after the originator's exclusivity has expired. Accountability promotes the development of a robust market by raising expected profits, particularly for an entrant with a relatively low likelihood of a safety problem. Yet entry need not improve consumer welfare, and may benefit the incumbent in our model. In contrast to the traditional entry deterrence mechanism, when accountability is sufficiently low, increased incumbent investment encourages entry. Our analysis has important implications for biologic drugs, insofar as pathways for entry by "biosimilars" have been established in Europe and the United States, and informs pharmacovigilance and other accountability policies for biologics.

Some models of vaccination behavior imply that an individual's willingness to vaccinate could be negatively correlated with the vaccination rate in her community. The rationale is that a higher community vaccination rate reduces the risk of contracting the vaccine-preventable disease and thus reduces the individual's incentive to vaccinate. At the same time, as for many health-related behaviors, individuals may want to conform to the vaccination behavior of peers, counteracting a reduced incentive to vaccinate due to herd immunity. Currently there is limited empirical evidence on how individual vaccination decisions respond to the vaccination decisions of peers. In the fall of 2014, we used a rapid survey technology to ask a large sample of U.S. adults about their willingness to use a vaccine for Ebola. Respondents expressed a greater inclination to use the vaccine in a hypothetical scenario with a high community vaccination rate. In particular, an increase in the community vaccination rate from 10% to 90% had the same impact on reported utilization as a nearly 50% reduction in out-of-pocket cost. These findings are consistent with a tendency to conform with vaccination among peers, and suggest that policies promoting vaccination could be more effective than has been recognized., Competing Interests: The authors have no competing interests to declare.

Importance: Thousands of physicians attend scientific meetings annually. Although hospital physician staffing and composition may be affected by meetings, patient outcomes and treatment patterns during meeting dates are unknown., Objective: To analyze mortality and treatment differences among patients admitted with acute cardiovascular conditions during dates of national cardiology meetings compared with nonmeeting dates., Design, Setting, and Participants: Retrospective analysis of 30-day mortality among Medicare beneficiaries hospitalized with acute myocardial infarction (AMI), heart failure, or cardiac arrest from 2002 through 2011 during dates of 2 national cardiology meetings compared with identical nonmeeting days in the 3 weeks before and after conferences (AMI, 8570 hospitalizations during 82 meeting days and 57,471 during 492 nonmeeting days; heart failure, 19,282 during meeting days and 11,4591 during nonmeeting days; cardiac arrest, 1564 during meeting days and 9580 during nonmeeting days). Multivariable analyses were conducted separately for major teaching hospitals and nonteaching hospitals and for low- and high-risk patients. Differences in treatment utilization were assessed., Exposures: Hospitalization during cardiology meeting dates., Main Outcomes and Measures: Thirty-day mortality, procedure rates, charges, length of stay., Results: Patient characteristics were similar between meeting and nonmeeting dates. In teaching hospitals, adjusted 30-day mortality was lower among high-risk patients with heart failure or cardiac arrest admitted during meeting vs nonmeeting dates (heart failure, 17.5% [95% CI, 13.7%-21.2%] vs 24.8% [95% CI, 22.9%-26.6%]; P < .001; cardiac arrest, 59.1% [95% CI, 51.4%-66.8%] vs 69.4% [95% CI, 66.2%-72.6%]; P = .01). Adjusted mortality for high-risk AMI in teaching hospitals was similar between meeting and nonmeeting dates (39.2% [95% CI, 31.8%-46.6%] vs 38.5% [95% CI, 35.0%-42.0%]; P = .86), although adjusted percutaneous coronary intervention (PCI) rates were lower during meetings (20.8% vs 28.2%; P = .02). No mortality or utilization differences existed for low-risk patients in teaching hospitals or high- or low-risk patients in nonteaching hospitals. In sensitivity analyses, cardiac mortality was not affected by hospitalization during oncology, gastroenterology, and orthopedics meetings, nor was gastrointestinal hemorrhage or hip fracture mortality affected by hospitalization during cardiology meetings., Conclusions and Relevance: High-risk patients with heart failure and cardiac arrest hospitalized in teaching hospitals had lower 30-day mortality when admitted during dates of national cardiology meetings. High-risk patients with AMI admitted to teaching hospitals during meetings were less likely to receive PCI, without any mortality effect.

Objective: To quantify in the context of chronic myeloid leukemia (CML) the additional value patients receive when innovative treatments enable them to survive until the advent of even more effective future treatments (ie, the "option value")., Study Design: Observational study using data from the Surveillance, Epidemiology and End Results (SEER) cancer registry comprising all US patients with CML diagnosed between 2000 and 2008 (N = 9,760)., Methods: We quantified the option value of recent breakthroughs in CML treatment by first conducting retrospective survival analyses on SEER data to assess the effectiveness of TKI treatments, and then forecasting survival from CML and other causes to measure expected future medical progress. We then developed an analytical framework to calculate option value of innovative CML therapies, and used an economic model to value these gains. We calculated the option value created both by future innovations in CML treatment and by medical progress in reducing background mortality., Results: For a recently diagnosed CML patient, the option value of innovative therapies from future medical innovation amounts to 0.76 life-years. This option value is worth $63,000, equivalent to 9% of the average survival gains from existing treatments. Future innovations in CML treatment jointly account for 96% of this benefit., Conclusions: The option value of innovative treatments has significance in the context of CML and, more broadly, in disease areas with rapid innovation. Incorporating option value into traditional valuations of medical innovations is both a feasible and a necessary practice in health technology assessment.

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.

Pharmaceutical companies and generic drug manufacturers have long been at odds over "data exclusivity" regulations. These rules require a waiting period of at least five years before generic drug companies can access valuable clinical trial data necessary to bring less expensive forms of innovative drugs to market. Pharmaceutical companies want the data exclusivity period lengthened to protect their investment. Generic manufacturers want the period shortened so that they can bring less expensive versions of drugs to patients sooner. We examine the long-term effect of extending the data exclusivity period for conventional "small-molecule" drugs to twelve years--the same exclusivity period already extended to large-molecule biologic drugs under the Affordable Care Act. We conclude that Americans would benefit from a longer period of data exclusivity.

Objective: To review and characterize existing health care efficiency measures in order to facilitate a common understanding about the adequacy of these methods., Data Sources: Review of the MedLine and EconLit databases for articles published from 1990 to 2008, as well as search of the "gray" literature for additional measures developed by private organizations., Study Design: We performed a systematic review for existing efficiency measures. We classified the efficiency measures by perspective, outputs, inputs, methods used, and reporting of scientific soundness., Principal Findings: We identified 265 measures in the peer-reviewed literature and eight measures in the gray literature, with little overlap between the two sets of measures. Almost all of the measures did not explicitly consider the quality of care. Thus, if quality varies substantially across groups, which is likely in some cases, the measures reflect only the costs of care, not efficiency. Evidence on the measures' scientific soundness was mostly lacking: evidence on reliability or validity was reported for six measures (2.3 percent) and sensitivity analyses were reported for 67 measures (25.3 percent)., Conclusions: Efficiency measures have been subjected to few rigorous evaluations of reliability and validity, and methods of accounting for quality of care in efficiency measurement are not well developed at this time. Use of these measures without greater understanding of these issues is likely to engender resistance from providers and could lead to unintended consequences.