Physician Electronic Health Record Use After Changes in US Centers for Medicare & Medicaid Services Documentation Requirements.

This cohort study examines changes in physician electronic health record (EHR) documentation time before and after changes in Centers for Medicare & Medicaid evaluation and management requirements.

One-Year Adverse Outcomes Among US Adults With Post-COVID-19 Condition vs Those Without COVID-19 in a Large Commercial Insurance Database.

Importance: Many individuals experience ongoing symptoms following the onset of COVID-19, characterized as postacute sequelae of SARS-CoV-2 or post-COVID-19 condition (PCC). Less is known about the long-term outcomes for these individuals. Objective: To quantify 1-year outcomes among individuals meeting a PCC definition compared with a control group of individuals without COVID-19. Design, Setting, and Participants: This case-control study with a propensity score-matched control group included members of commercial health plans and used national insurance claims data enhanced with laboratory results and mortality data from the Social Security Administration's Death Master File and Datavant Flatiron data. The study sample consisted of adults meeting a claims-based definition for PCC with a 2:1 matched control cohort of individuals with no evidence of COVID-19 during the time period of April 1, 2020, to July 31, 2021. Exposures: Individuals experiencing postacute sequelae of SARS-CoV-2 using a Centers for Disease Control and Prevention-based definition. Main Outcomes and Measures: Adverse outcomes, including cardiovascular and respiratory outcomes and mortality, for individuals with PCC and controls assessed over a 12-month period. Results: The study population included 13 435 individuals with PCC and 26 870 individuals with no evidence of COVID-19 (mean [SD] age, 51 [15.1] years; 58.4% female). During follow-up, the PCC cohort experienced increased health care utilization for a wide range of adverse outcomes: cardiac arrhythmias (relative risk [RR], 2.35; 95% CI, 2.26-2.45), pulmonary embolism (RR, 3.64; 95% CI, 3.23-3.92), ischemic stroke (RR, 2.17; 95% CI, 1.98-2.52), coronary artery disease (RR, 1.78; 95% CI, 1.70-1.88), heart failure (RR, 1.97; 95% CI, 1.84-2.10), chronic obstructive pulmonary disease (RR, 1.94; 95% CI, 1.88-2.00), and asthma (RR, 1.95; 95% CI, 1.86-2.03). The PCC cohort also experienced increased mortality, as 2.8% of individuals with PCC vs 1.2% of controls died, implying an excess death rate of 16.4 per 1000 individuals. Conclusions and Relevance: This case-control study leveraged a large commercial insurance database and found increased rates of adverse outcomes over a 1-year period for a PCC cohort surviving the acute phase of illness. The results indicate a need for continued monitoring for at-risk individuals, particularly in the area of cardiovascular and pulmonary management.

Assessment of structured data elements for social risk factors.

OBJECTIVES: Computable social risk factor phenotypes derived from routinely collected structured electronic health record (EHR) or health information exchange (HIE) data may represent a feasible and robust approach to measuring social factors. This study convened an expert panel to identify and assess the quality of individual EHR and HIE structured data elements that could be used as components in future computable social risk factor phenotypes. STUDY DESIGN: Technical expert panel. METHODS: A 2-round Delphi technique included 17 experts with an in-depth knowledge of available EHR and/or HIE data. The first-round identification sessions followed a nominal group approach to generate candidate data elements that may relate to socioeconomics, cultural context, social relationships, and community context. In the second-round survey, panelists rated each data element according to overall data quality and likelihood of systematic differences in quality across populations (ie, bias). RESULTS: Panelists identified a total of 89 structured data elements. About half of the data elements (n = 45) were related to socioeconomic characteristics. The panelists identified a diverse set of data elements. Elements used in reimbursement-related processes were generally rated as higher quality. Panelists noted that several data elements may be subject to implicit bias or reflect biased systems of care, which may limit their utility in measuring social factors. CONCLUSIONS: Routinely collected structured data within EHR and HIE systems may reflect patient social risk factors. Identifying and assessing available data elements serves as a foundational step toward developing future computable social factor phenotypes.

The Impact of Censoring Drug Switching in Medication Adherence Measures of Chronic Single Ingredient Oral Drugs.

We explored how drug switching impacts adherence measures for common chronic oral medications. Switching between ingredients with the same indication was detected within a 30-day grace period. The proportion of days covered (PDC) and adherent status (cutoff 0.8) for each ingredient was calculated and compared between different censoring approaches: censoring drug switching (PDCswitch), censoring the end of dispensing (PDCend), and fixed 365-day period (PDC365). Overall, 854,380 (15.9%) patients in the Optum ClinFormatics (Optum) and 150,785 (22.0%) patients in the MarketScan Multi-state Medicaid (MDCD) had at least one switch within one year. Compared with PDC365 in Optum, PDCswitch means were higher: 0.85 vs. 0.41 for antihypertensive, 0.82 vs. 0.46 for antihyperglycemics, and 0.84 vs. 0.33 for antihyerlipidemia. Further, the percentages of adherent patients were higher: 95.8% vs. 17.9% for antihypertensive, 85.5% vs. 18.9% for antihyperglycemics, and 72.1% vs. 5.3% for antihyerlipidemia. Significant and modest changes were observed between PDCswitch and PDCend.

A Comparison of Data Driven-based Measures of Adherence to Oral Hypoglycemic Agents in Medicaid Patients.

We evaluated and compared different methods for measuring adherence to Oral Antihyperglycemic Agents (OHA), based on the correlation between these measures and glycated hemoglobin A1C (HbA1c) levels in Medicaid patients with Type 2 diabetes. An observational sample of 831 Medicaid patients with Type 2 diabetes who had HbA1c test results recorded between January 1, 2001 and December 31, 2005 was identified in the Indiana Network of Patient Care (INPC). OHA adherence was measured by medication possession ratio (MPR), proportion of days covered (PDC), and the number of gaps (GAP) for 3, 6, and 12-month intervals prior to the HbA1c test date. All three OHA adherence measurements showed consistent and significant correlation with HbA1c level. The 6-month PDC showed the strongest association with HbA1c levels in both unadjusted (-1.07, P<0.0001) and adjusted (-1.12, P<0.0001) models.

Empirical assessment of methods for risk identification in healthcare data: results from the experiments of the Observational Medical Outcomes Partnership.

BACKGROUND: Expanded availability of observational healthcare data (both administrative claims and electronic health records) has prompted the development of statistical methods for identifying adverse events associated with medical products, but the operating characteristics of these methods when applied to the real-world data are unknown. METHODS: We studied the performance of eight analytic methods for estimating of the strength of association-relative risk (RR) and associated standard error of 53 drug-adverse event outcome pairs, both positive and negative controls. The methods were applied to a network of ten observational healthcare databases, comprising over 130 million lives. Performance measures included sensitivity, specificity, and positive predictive value of methods at RR thresholds achieving statistical significance of p < 0.05 or p < 0.001 and with absolute threshold RR > 1.5, as well as threshold-free measures such as area under receiver operating characteristic curve (AUC). RESULTS: Although no specific method demonstrated superior performance, the aggregate results provide a benchmark and baseline expectation for risk identification method performance. At traditional levels of statistical significance (RR > 1, p < 0.05), all methods have a false positive rate >18%, with positive predictive value <38%. The best predictive model, high-dimensional propensity score, achieved an AUC = 0.77. At 50% sensitivity, false positive rate ranged from 16% to 30%. At 10% false positive rate, sensitivity of the methods ranged from 9% to 33%. CONCLUSIONS: Systematic processes for risk identification can provide useful information to supplement an overall safety assessment, but assessment of methods performance suggests a substantial chance of identifying false positive associations.

Data for drugs available through low-cost prescription drug programs are available through pharmacy benefit manager and claims data.

BACKGROUND: Observational data are increasingly being used for pharmacoepidemiological, health services and clinical effectiveness research. Since pharmacies first introduced low-cost prescription programs (LCPP), researchers have worried that data about the medications provided through these programs might not be available in observational data derived from administrative sources, such as payer claims or pharmacy benefit management (PBM) company transactions. METHOD: We used data from the Indiana Network for Patient Care to estimate the proportion of patients with type 2 diabetes to whom an oral hypoglycemic agent was dispensed. Based on these estimates, we compared the proportions of patients who received medications from chains that do and do not offer an LCPP, the proportion trend over time based on claims data from a single payer, and to proportions estimated from the Medical Expenditure Panel Survey (MEPS). RESULTS: We found that the proportion of patients with type 2 diabetes who received oral hypoglycemic medications did not vary based on whether the chain that dispensed the drug offered an LCPP or over time. Additionally, the rates were comparable to those estimated from MEPS. CONCLUSION: Researchers can be reassured that data for medications available through LCPPs continue to be available through administrative data sources.

Variability in drug formularies and implications in decision support.

Formularies are highly variable, which limits physicians ability to prescribe cost effective medications for their patients. In this study we explore the composition of 3,346 formularies in terms of outpatient prescription coverage, medication class coverage, and cost implications. Our analysis revealed that 42% of formularies are duplicative and that the unique formularies contain variability for medications that contribute little in terms of cost or overall use. These results lead us to believe the number and complexities of formularies can be dramatically reduced leading to more intuitive decision support for physicians when writing prescriptions.

Race and medication adherence and glycemic control: findings from an operational health information exchange.

The Central Indiana Beacon Community leads efforts for improving adherence to oral hypoglycemic agents (OHA) to achieve improvements in glycemic control for patients with type 2 diabetes. In this study, we explored how OHA adherence affected hemoglobin A1C (HbA1c) level in different racial groups. OHA adherence was measured by 6-month proportion of days covered (PDC). Of 3,976 eligible subjects, 12,874 pairs of 6-month PDC and HbA1c levels were formed between 2002 and 2008. The average HbA1c levels were 7.4% for African-Americans and 6.5% for Whites. The average 6-month PDCs were 40% for African-Americans and 50% for Whites. In mixed effect generalized linear regression analyses, OHA adherence was inversely correlated with HbA1c level for both African-Americans (-0.80, p<0.0001) and Whites (-0.53, p<0.0001). The coefficient was -0.26 (p<0.0001) for the interaction of 6-month PDC and African-Americans. Significant risk factors for OHA non-adherence were race, young age, non-commercial insurance, newly-treated status, and polypharmacy.

Advancing the science for active surveillance: rationale and design for the Observational Medical Outcomes Partnership.

The U.S. Food and Drug Administration (FDA) Amendments Act of 2007 mandated that the FDA develop a system for using automated health care data to identify risks of marketed drugs and other medical products. The Observational Medical Outcomes Partnership is a public-private partnership among the FDA, academia, data owners, and the pharmaceutical industry that is responding to the need to advance the science of active medical product safety surveillance by using existing observational databases. The Observational Medical Outcomes Partnership's transparent, open innovation approach is designed to systematically and empirically study critical governance, data resource, and methodological issues and their interrelationships in establishing a viable national program of active drug safety surveillance by using observational data. This article describes the governance structure, data-access model, methods-testing approach, and technology development of this effort, as well as the work that has been initiated.

A Framework for evaluating the costs, effort, and value of nationwide health information exchange.

OBJECTIVE: The nationwide health information network (NHIN) has been proposed to securely link community and state health information exchange (HIE) entities to create a national, interoperable network for sharing healthcare data in the USA. This paper describes a framework for evaluating the costs, effort, and value of nationwide data exchange as the NHIN moves toward a production state. The paper further presents the results of an initial assessment of the framework by those engaged in HIE activities. DESIGN: Using a literature review and knowledge gained from active NHIN technology and policy development, the authors constructed a framework for evaluating the costs, effort, and value of data exchange between an HIE entity and the NHIN. MEASUREMENT: An online survey was used to assess the perceived usefulness of the metrics in the framework among HIE professionals and researchers. RESULTS: The framework is organized into five broad categories: implementation; technology; policy; data; and value. Each category enumerates a variety of measures and measure types. Survey respondents generally indicated the framework contained useful measures for current and future use in HIE and NHIN evaluation. Answers varied slightly based on a respondent's participation in active development of NHIN components. CONCLUSION: The proposed framework supports efforts to measure the costs, effort, and value associated with nationwide data exchange. Collecting longitudinal data along the NHIN's path to production should help with the development of an evidence base that will drive adoption, create value, and stimulate further investment in nationwide data exchange.

Preparing for an aging population and improving chronic disease management.

New models of health care delivery are inevitable. There is likely to be increasing emphasis on patient self-monitoring, health care delivery at patient homes, interdisciplinary treatment plans, a greater percentage of medical care delivered by non-physician health professionals, targeted health educational materials, and greater involvement and training of informal caregivers. The Information Technologies (IT) infrastructure of health systems will need to adapt. We have begun sorting out the implications of this future within a County public hospital system: defining the desirable features, relevant technologies, necessary modifications to the network, and additional data elements to be captured. We seek to build an infrastructure that will support new patient-focused technologies designed to more efficiently and effectively support older individuals. We hypothesize utility to further exploring the impact that new health care delivery models will have on health systems' IT infrastructures.

Building a production-ready infrastructure to enhance medication management: early lessons from the nationwide health information network.

Poor medication management practices can lead to serious erosion of health care quality and safety. The DHHS Medication Management Use Case outlines methods for the exchange of electronic health information to improve medication management practices. In this case report, the authors describe initial development of Nationwide Health Information Network (NHIN) services to support the Medication Management Use Case. The technical approach and core elements of medication management transactions involved in the NHIN are presented. Early lessons suggest the pathway to improvements in quality and safety are achievable, yet there are challenges for the medical informatics community to address through future research and development activities.

Rural RHIOs: common issues in the development of two state-wide health information networks.

UNLABELLED: Over one hundred Regional Health Information Organizations (RHIOs) are under development in the United States. Many of these will fail but many will become a vital part of the Nationwide Health Information Network (NHIN). METHODS: Documentation was reviewed and summarized and a core group of Vermont Information Technology Leaders (VITL, Inc.) were interviewed to ascertained lessons learned in the development of Vermont's RHIO. RESULTS: Issues were grouped into five major categories: early planning, organization, education and marketing, technology, and financial sustainability. CONCLUSION: There are a number of commonalities about all RHIOs but also a number of differences predicated on location. RHIOs must remain dynamic and learn from others in order to survive.

Arthritis quality indicators for the Veterans Administration: implications for electronic data collection, storage format, quality assessment, and clinical decision support.

The Veterans Administration (VA) uses information technology and performance measures to improve quality and efficiency. The VA stores all patient data electronically. Manual quality assessment audits are performed every three months. They are time consuming and expensive. Automated reviews would be more efficient. But the patient records are neither sufficiently coded nor structured to allow for full machine interpretability. Evidence-based rheumatology quality indicators have been proposed for inclusion in the quality data set. Automated reviews for some conditions would be possible with modification to some VA electronic data entry screens and to the underlying data repository. This effort would risk the imposition of untenable data entry and workflow burdens upon clinicians. This paper outlines some specific considerations for one disease, rheumatoid arthritis.

The cost of adverse drug events in ambulatory care.

BACKGROUND: Many justifications for ePrescribing predict savings achieved by reducing the number of adverse drug events (ADEs) in the ambulatory setting however, there is little evidence from which to estimate the size of these savings. Estimating the cost of ADEs in the ambulatory setting would improve the reliability of these predictions. METHODS: We identified patients with potential ADEs in a primary care practice setting and characterized the patient's age along with charge and utilization indicators for 6 weeks pre- and post-event. We then used linear regression to determine charges attributable to an ADE. RESULTS: Charges were higher for patients following an ambulatory visit who were determined to have ADEs. This occurred in a linear fashion: 2 ADEs ($4,976); 1 ADE ($2,337); and no ADEs ($1,943). The charge attributable to a single ADE is $643 (2001 US dollars) or $926 (cost adjusted to 2006 US dollars). CONCLUSIONS: Patients with ADEs incur greater charges. The charges attributable to an ambulatory ADE are a significant cost to the health care delivery system on the order of $8 billion annually.

A tale of three cities--where RHIOS meet the NHIN.

Regional health information exchanges in California, Indiana, and Massachusetts have been collaborating on a prototype for a nationwide health information network, first under the auspices of the Markle Foundation's Connecting for Health program and now under contract to the Department of Health and Human Services' Office of the National Coordinator for Health Information Technology. Since mid-2004, this collaboration has evolved from a collection of regional efforts to a standards-driven cooperative and now to one of four prototype national networks fostered by federal efforts. This development reflects a maturing market for interoperability and integration in healthcare information technology, starting with RHIOs, and suggests one response to the industry's need for the type of plug-and-play information exchange available in other industries. The authors share their experiences and their views of how RHIOs and a Nationwide Health Information Network will further develop to make interoperable electronic health records a reality in coming years. The content of this article is solely the responsibility of the authors and does not necessarily represent the official view of the Office of the National Coordinator for Health Information Technology.

Exchanging health information: local distribution, national coordination.

The fragmentation of our health care system, our need to accommodate the diversity of existing health information exchanges, the lack of consistent implementation of clinical information standards, and the need to protect patients' privacy and maintain trust are all challenges to overcome in achieving broad-scale interoperable health information exchange. We propose several steps to coordinate information sharing among regional and other networks through universal adherence to a basic framework of policies and standards. The critical policy action is the identification of a "common framework" of standards and policies, maintained by a new Standards and Policy Entity that reflects both public- and private-sector participation.

Communities' readiness for health information exchange: the National Landscape in 2004.

BACKGROUND: The Secretary of Health and Human Services recently released a report calling for the nation to create a national health information network (NHIN) that would interconnect Regional Health Information Organizations (RHIOs). These RHIOs, which others have called Local or Regional Health Information Infrastructures (LHII), would in turn interconnect local as well as national health information resources. Little data exist about the activities taking place in communities to create LHIIs. APPROACH: The authors analyzed data that communities submitted in response to a request for capabilities issued by the Foundation for eHealth as part of their Connecting Communities for Better Health program using descriptive statistics and subjective evaluation. IMPRESSION: The authors analyzed data from 134 responses from communities in 42 states and the District of Columbia. Communities are enthusiastic about moving forward with health information exchange to create LHIIs to improve the efficiency, quality, and safety of care. They have identified significant local sources of investment and plan to use some clinical data standards but not as broadly as was expected. The communities have not yet developed the specific technical approaches or the sustainable business models that will be required. Many communities are interested in creating an LHII and are developing the leadership commitment needed to translate that interest into an operational reality. Clinical information standards can be incorporated into a community's plans as often as they need to be. Communities have to overcome funding issues, develop deeper understanding of the technical and organizational issues, and aggressively share their learning to succeed within their community and to help other communities succeed.

A consensus action agenda for achieving the national health information infrastructure.

BACKGROUND: Improving the safety, quality, and efficiency of health care will require immediate and ubiquitous access to complete patient information and decision support provided through a National Health Information Infrastructure (NHII). METHODS: To help define the action steps needed to achieve an NHII, the U.S. Department of Health and Human Services sponsored a national consensus conference in July 2003. RESULTS: Attendees favored a public-private coordination group to guide NHII activities, provide education, share resources, and monitor relevant metrics to mark progress. They identified financial incentives, health information standards, and overcoming a few important legal obstacles as key NHII enablers. Community and regional implementation projects, including consumer access to a personal health record, were seen as necessary to demonstrate comprehensive functional systems that can serve as models for the entire nation. Finally, the participants identified the need for increased funding for research on the impact of health information technology on patient safety and quality of care. Individuals, organizations, and federal agencies are using these consensus recommendations to guide NHII efforts.