Impact of a targeted monitoring on data-quality and data-management workload of randomized controlled trials: A prospective comparative study.

AIMS: Monitoring risk-based approaches in clinical trials are encouraged by regulatory guidance. However, the impact of a targeted source data verification (SDV) on data-management (DM) workload and on final data quality needs to be addressed. METHODS: MONITORING was a prospective study aiming at comparing full SDV (100% of data verified for all patients) and targeted SDV (only key data verified for all patients) followed by the same DM program (detecting missing data and checking consistency) on final data quality, global workload and staffing costs. RESULTS: In all, 137 008 data including 18 124 key data were collected for 126 patients from 6 clinical trials. Compared to the final database obtained using the full SDV monitoring process, the final database obtained using the targeted SDV monitoring process had a residual error rate of 1.47% (95% confidence interval, 1.41-1.53%) on overall data and 0.78% (95% confidence interval, 0.65-0.91%) on key data. There were nearly 4 times more queries per study with targeted SDV than with full SDV (mean ± standard deviation: 132 ± 101 vs 34 ± 26; P = .03). For a handling time of 15 minutes per query, the global workload of the targeted SDV monitoring strategy remained below that of the full SDV monitoring strategy. From 25 minutes per query it was above, increasing progressively to represent a 50% increase for 45 minutes per query. CONCLUSION: Targeted SDV monitoring is accompanied by increased workload for DM, which allows to obtain a small proportion of remaining errors on key data (<1%), but may substantially increase trial costs.

The form, the permit and the photograph: an archive of mobility between South Africa and India.

Inspired by recent scholarship that calls for a more critical engagement with archives and knowledge production, this article plots the biography of an archive in Cape Town. Unravelling the layers of paperwork, it locates the origins of the archive in a repressive state project of excluding Indian immigrants and controlling those within the borders of the Cape Colony. The paper trail reveals documents of identity and the state's attempts to verify identity. In seeking to answer the question as to how the historian should approach such an archive of control and surveillance, it concludes that a social history and gendered approach to migration is possible and the real treasures are those documents that enter the archive beyond the limits of state intentions.

How Should Home-Based Maternal and Child Health Records Be Implemented? A Global Framework Analysis.

BACKGROUND: A home-based record (HBR) is a health document kept by the patient or their caregivers, rather than by the health care facility. HBRs are used in 163 countries, but they have not been implemented universally or consistently. Effective implementation maximizes both health impacts and cost-effectiveness. We sought to examine this research-to-practice gap and delineate the facilitators and barriers to the effective implementation and use of maternal and child health HBRs especially in low- and middle-income countries (LMICs). METHODS: Using a framework analysis approach, we created a framework of implementation categories in advance using subject expert inputs. We collected information through 2 streams. First, we screened 69 gray literature documents, of which 18 were included for analysis. Second, we conducted semi-structured interviews with 12 key informants, each of whom had extensive experience with HBR implementation. We abstracted the relevant data from the documents and interviews into an analytic matrix. The matrix was based on the initial framework and adjusted according to emergent categories from the data. RESULTS: We identified 8 contributors to successful HBR implementation. These include establishing high-level support from the government and ensuring clear communication between all ministries and nongovernmental organizations involved. Choice of appropriate contents within the record was noted as important for alignment with the health system and for end user acceptance, as were the design, its physical durability, and timely redesigns. Logistical considerations, such as covering costs sustainably and arranging printing and distribution, could be potential bottlenecks. Finally, end users' engagement with HBRs depended on how the record was initially introduced to them and how its importance was reinforced over time by those in leadership positions. CONCLUSIONS: This framework analysis is the first study to take a more comprehensive and broad approach to the HBR implementation process in LMICs. The findings provide guidance for policy makers, donors, and health care practitioners regarding best implementation practice and effective HBR use, as well as where further research is required.

A cost-benefit analysis of endoscopy reporting methods: handwritten, dictated and computerized.

BACKGROUND AND STUDY AIMS: Gastrointestinal endoscopy investigations are frequently requested by gastroenterologists, general practitioners and other physicians. In addition to the classic methods of report writing, several electronic endoscopic report systems are currently available. The aim of the study was to evaluate the costs of three different ways of producing reports; by hand, by dictation, or by computer. METHODS: Three methods of report writing were compared, with special attention to costs. The endoscopy process was analyzed, from arrival of the patient to sending the report to the referring doctor, and including production of endoscopic images or video, logging of used endoscopes and their disinfection, and storage costs for endoscopy data. RESULTS: During the first 5 years, the mean costs per procedure were Euro 4.78 for handwritten, Euro 6.39 for dictated and Euro 8.90 for computerized reports. Due to depreciation, after this initial period, the respective costs declined to Euro 4.37, Euro 5.20 and Euro 5.13, respectively. Despite high initial costs, a cost-benefit analysis already revealed a financial benefit from a computerized system after 3 years. CONCLUSIONS: The electronic production of an endoscopic report turned out to be the most expensive way of report writing during the first 5 years, due to high initial costs. After 5 years the costs of the different systems were comparable with each other. Cost-benefit analysis showed a positive financial benefit for computerized reports after 3 years.

Miscoding: a threat to the hospital care system. How to detect it?

BACKGROUND: Artificially influencing the case mix of hospitals may have several deleterious consequences for the hospital care system. One distinguishes over-evaluation (up-coding) and under-evaluation (under-coding) of the case mix. Apart from its financial consequences, miscoding may cause a fracture in epidemiological time series and, by increasing artificially the severity of illness, may affect the assessment of the quality of hospital care, based on administrative data. METHODS: Fixed effects models were used to assess deviant coding behavior at the hospital level. To do so, we examined the linear evolution over time of characteristics such as length of stay and of 21 "triggering" conditions susceptible to increase the case mix of a stay. In case of deviant coding, these triggering conditions were checked to direct the audit towards fraud-suspected discharge abstracts. Hereto, a method consisting in comparing a single hospital's linear evolution over time with the national linear evolution over time was developed, using an interaction term between linear evolution over time and hospitals. To test this methodology, fraud-directed audits were carried out in addition to the usual, at random audits. RESULTS: Important inter-hospital differences in the linear evolution over time of several characteristics of Belgian hospitals were identified, as well as evidence not only of improving coding practices, but also of up-coding, fraudulent under-coding and of numerous coding errors without financial impact. The coding errors, ascertained in the at random audit, resulted in a wrongful gain for the faulty hospitals of 28.23 days in 258 stays, whereas in case of fraud-directed audits these figures amounted up to 642.68 days in 334 stays. CONCLUSION: Fraud-directed audit may constitute a valuable tool in the quality assurance of administrative databases, improving their use in epidemiology and assessment of the quality of care.

Extracorporeal membrane oxygenation: current clinical practice, coding, and reimbursement.

Extracorporeal membrane oxygenation (ECMO) is a technique for providing life support for patients experiencing both pulmonary and cardiac failure by maintaining oxygenation and perfusion until native organ function is restored. ECMO is used routinely at many specialized hospitals for infants and less commonly for children with respiratory or cardiac failure from a variety of causes. Its usage is more controversial in adults, but select medical centers have reported favorable findings in patients with ARDS and other causes of severe pulmonary failure. ECMO is also rarely used as a rescue therapy in a small subset of adult patients with cardiac failure. This article will review the current uses and techniques of ECMO in the critical care setting as well as the evidence supporting its usage. In addition, current practice management related to coding and reimbursement for this intensive therapy will be discussed.

Burden of concomitant asthma and COPD in a Medicaid population.

BACKGROUND: Asthma and COPD can significantly affect patients and pose a substantial economic burden for both patients and managed-care plans. This study compares utilization outcomes in patients with asthma, COPD, or co-occurring asthma and COPD in a Medicaid population, and assesses the incremental burden of COPD in patients with asthma. METHODS: We queried medical claims of Medicaid patients aged 40 to 64 years with asthma and/or COPD filed between January 1, 2001, and December 31, 2003, from encounter data. COPD patients were identified based on at least one claim with International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9) codes 491, 492, 496; and asthma patients were identified on the basis of ICD-9 code 493 as diagnosis. We analyzed annual utilization and cost of hospitalizations, physician, and outpatient services attributable to asthma and/or COPD. RESULTS: The analysis included a total of 3,072 asthma, 3,455 COPD, and 2,604 COPD/asthma patients. COPD/asthma co-occurring disease has higher utilization of any service type than either disease alone. Compared with asthma patients, COPD patients were 16% and 51% more likely to use physician (odds ratio [OR], 1.16; 95% confidence interval [CI], 1.01 to 1.34) and inpatient services (OR, 1.51; 95% CI, 1.31 to 1.74), respectively; and 60% less likely to use outpatient services (OR, 0.40; 95% CI, 0.35 to 0.46). Compared with asthma patients, COPD patients and COPD/asthma co-occurring patients cost 50% (OR, 1.50; 95% CI, 1.3 to 1.74) and five times (OR, 5.25; 95% CI, 4.59 to 6.02) more for total medical services, respectively. CONCLUSION: Our data suggest that patients with COPD and co-occurring COPD/asthma were sicker and used more medical services than asthma patients. The incremental burden of COPD to patients with asthma is significant.

[The German diagnosis-related groups in urology: reproducibility and quality of coding]. / G-DRG-System für die Urologie : Reproduzierbarkeit und Kodierqualität.

BACKGROUND: The German diagnosis-related group (G-DRG) system is based on the belief that there is only one specific coding for each case. The aim of this study was to compare coding results of identical cases coded by different coding specialists. MATERIAL AND METHODS: Charts of six anonymous cases -- except final letter and coding -- were sent to 20 German departments of urology. They were asked to let their coding specialists do a DRG coding of these cases. The response rate was 90%. RESULTS: Each case was coded in a different way by each coding specialist. The DRG refunding varied by 6-23%. The coding differences were caused by different interpretations of definitions in the DRG system and also by inaccurate chart analysis. CONCLUSION: The present DRG system allows a wide range of interpretation, leading to aggravation of the ongoing disputes between hospitals and insurance companies.

EHR's effect on the revenue cycle management Coding function.

Without administrative terminologies there is no revenue to manage. The use of healthcare IT to capture the codes for administrative and financial support functions will impact the revenue cycle and the management of it. This is presumed to occur because clinical data coded at the point of care becomes the source for claims data. Thus, as electronic health record system applications utilizing terminologies are implemented, healthcare providers need to systematically consider the effect on the coding function and management of the revenue cycle. A key factor is the sequence of events changes, i.e., instead of a health information management professional selecting billing codes at the conclusion of an encounter based on the review of the record, clinical data generates the claims data via mapping. Efficiencies and management challenges result.

The right moves for success with Medicare.

Hospitals can take these steps to meet payment reform challenges: Analyze the financial impact of payment changes. Benchmark performance against peers. Audit and educate physicians. Implement a concurrent documentation program. Focus on length of stay. Get ready for RACs. Take charge of charge capture. Prevent coding duplication. Conduct a pricing review. Validate payment reconciliation processes.

A pilot study to document the return on investment for implementing an ambulatory electronic health record at an academic medical center.

BACKGROUND: Adoption rates for electronic health records (EHRs) have been slow, despite growing enthusiasm. Cost is a frequently cited obstacle to implementing an EHR. The body of literature citing a positive return on investment is largely anecdotal and infrequently published in peer-reviewed journals. STUDY DESIGN: Five ambulatory offices, with a total of 28 providers, within the University of Rochester Medical Center, participated in a pilot project using an EHR to document the return on investment. A staged implementation of the Touchworks EHR (Allscripts) was undertaken from November 2003 to March 2004. Measurements of key financial indicators were made in the third calendar quarters of 2003 and 2005. These indicators included chart pulls, new chart creation, filing time, support staff salary, and transcription costs. In addition, patient cycle time, evaluation and management codes billed, and days in accounts receivable were evaluated to assess impact on office efficiency and billing. The savings realized were compared with the costs of the first 2 years of EHR use to determine return on investment. RESULTS: Total annual savings were $393,662 ($14,055 per provider). Total capital cost was $484,577. First-year operating expenses were $24,539. Total expenses for the first year were $509,539 ($18,182 per provider). Ongoing annual cost for subsequent years is $114,016 ($4,072 per provider). So, initial costs were recaptured within 16 months, with ongoing annual savings of $9,983 per provider. CONCLUSIONS: An EHR can rapidly demonstrate a positive return on investment when implemented in ambulatory offices associated with a university medical center, with a neutral impact on efficiency and billing.

Physician code creep: evidence in Medicaid and State Employee Health Insurance billing.

This study estimates a fixed effects ordered logit model physician office visit billing using claims data from South Carolina Medicaid and the State Employees Health Plan. The results find code creep increasing expenditures on physician office visits at a rate of 2.2 percent annually for both programs, with no significant difference in the rate between the two. The models also indicate that physician billing patterns differ between the programs, with the Medicaid claims averaging 1.3 percent less per visit than comparable State Employees Health Plan claims.

Medicare program; hospital outpatient prospective payment system and CY 2007 payment rates; CY 2007 update to the ambulatory surgical center covered procedures list; Medicare administrative contractors; and reporting hospital quality data for FY 2008 inpatient prospective payment system annual payment update program--HCAHPS survey, SCIP, and mortality. Final rule with comment period and final rule.

This final rule with comment period revises the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system, and to implement certain related provisions of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 and the Deficit Reduction Act (DRA) of 2005. In this final rule with comment period, we describe changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes are applicable to services furnished on or after January 1, 2007. In addition, this final rule with comment period implements future CY 2009 required reporting on quality measures for hospital outpatient services paid under the prospective payment system. This final rule with comment period revises the current list of procedures that are covered when furnished in a Medicare-approved ambulatory surgical center (ASC), which are applicable to services furnished on or after January 1, 2007. This final rule with comment period revises the emergency medical screening requirements for critical access hospitals (CAHs). This final rule with comment period supports implementation of a restructuring of the contracting entities responsibilities and functions that support the adjudication of Medicare fee-for-service (FFS) claims. This restructuring is directed by section 1874A of the Act, as added by section 911 of the MMA. The prior separate Medicare intermediary and Medicare carrier contracting authorities under Title XVIII of the Act have been replaced with the Medicare Administrative Contractor (MAC) authority. This final rule continues to implement the requirements of the DRA that require that we expand the "starter set" of 10 quality measures that we used in FY 2005 and FY 2006 for the hospital inpatient prospective payment system (IPPS) Reporting Hospital Quality Data for the Annual Payment Update (RHQDAPU) program. We began to adopt expanded measures effective for payments beginning in FY 2007. In this rule, we are finalizing additional quality measures for the expanded set of measures for FY 2008 payment purposes. These measures include the HCAHPS survey, as well as Surgical Care Improvement Project (SCIP, formerly Surgical Infection Prevention (SIP)), and Mortality quality measures.