High burden and unmet patient needs in chronic kidney disease.

Chronic kidney disease (CKD) is a complex debilitating condition affecting more than 70 million people worldwide. With the increased prevalence in risk factors such as diabetes, hypertension, and cardiovascular disease in an aging population, CKD prevalence is also expected to increase. Increased awareness and understanding of the overall CKD burden by health care teams (patients, clinicians, and payers) is warranted so that overall care and treatment management may improve. This review of the burden of CKD summarizes available evidence of the clinical, humanistic, and economic burden of CKD and the current unmet need for new treatments and serves as a resource on the overall burden. Across countries, CKD prevalence varies considerably and is dependent upon patient characteristics. The prevalence of risk factors including diabetes, hypertension, cardiovascular disease, and congestive heart failure is noticeably higher in patients with lower estimated glomerular filtration rates (eGFRs) and results in highly complex CKD patient populations. As CKD severity worsens, there is a subsequent decline in patient health-related quality of life and an increased use of health care resources as well as burgeoning costs. With current treatment, nearly half of patients progress to unfavorable renal and cardiovascular outcomes. Although curative treatment that will arrest kidney deterioration is desired, innovative agents under investigation for CKD to slow kidney deterioration, such as atrasentan, bardoxolone methyl, and spherical carbon adsorbent, may offer patients healthier and more productive lives.

Growth hormone is effective in treatment of short stature associated with short stature homeobox-containing gene deficiency: Two-year results of a randomized, controlled, multicenter trial.

BACKGROUND: The short stature homeobox-containing gene, SHOX, located on the distal ends of the X and Y chromosomes, encodes a homeodomain transcription factor responsible for a significant proportion of long-bone growth. Patients with mutations or deletions of SHOX, including those with Turner syndrome (TS) who are haplo-insufficient for SHOX, have variable degrees of growth impairment, with or without a spectrum of skeletal anomalies consistent with dyschondrosteosis. OBJECTIVE: Our objective was to determine the efficacy of GH in treating short stature associated with short stature homeobox-containing gene deficiency (SHOX-D). DESIGN AND METHODS: Fifty-two prepubertal subjects (24 male, 28 female; age, 3.0-12.3 yr) with a molecularly proven SHOX gene defect and height below the third percentile for age and gender (or height below the 10th percentile and height velocity below the 25th percentile) were randomized to either a GH-treatment group (n = 27) or an untreated control group (n = 25) for 2 yr. To compare the GH treatment effect between subjects with SHOX-D and those with TS, a third study group, 26 patients with TS aged 4.5-11.8 yr, also received GH. Between-group comparisons of first-year and second-year height velocity, height sd score, and height gain (cm) were performed using analysis of covariance accounting for diagnosis, sex, and baseline age. RESULTS: The GH-treated SHOX-D group had a significantly greater first-year height velocity than the untreated control group (mean +/- se, 8.7 +/- 0.3 vs. 5.2 +/- 0.2 cm/yr; P < 0.001) and similar first-year height velocity to GH-treated subjects with TS (8.9 +/- 0.4 cm/yr; P = 0.592). GH-treated subjects also had significantly greater second-year height velocity (7.3 +/- 0.2 vs. 5.4 +/- 0.2 cm/yr; P < 0.001), second-year height sd score (-2.1 +/- 0.2 vs.-3.0 +/- 0.2; P < 0.001) and second-year height gain (16.4 +/- 0.4 vs. 10.5 +/- 0.4 cm; P < 0.001) than untreated subjects. CONCLUSIONS: This large-scale, randomized, multicenter clinical trial in subjects with SHOX-D demonstrates marked, highly significant, GH-stimulated increases in height velocity and height SDS during the 2-yr study period. The efficacy of GH treatment in subjects with SHOX-D was equivalent to that seen in subjects with TS. We conclude that GH is effective in improving the linear growth of patients with various forms of SHOX-D.

Impact of HIV/AIDS on care and outcomes of severe sepsis.

INTRODUCTION: There has been dramatic improvement in survival for patients with HIV/AIDS; however, some studies on patients with HIV/AIDS and serious illness have reported continued low rates of intensive care. The purpose of this study was to examine patterns of care and outcomes for patients with severe sepsis and HIV/AIDS and compare them with those of patients with severe sepsis without HIV/AIDS. METHODS: We assessed data from all 1999 discharge abstracts from all non-federal hospitals in six US states. Patient demographic characteristics, discharge diagnoses, resource use, and outcomes were extracted. Analyses were performed using chi-square, Wilcoxon rank sum, or regression techniques, as appropriate. RESULTS: We identified 74,020 patients with severe sepsis (7,638 (10.3%) had HIV/AIDS) using ICD-9-CM codes. Patients with severe sepsis and HIV/AIDS had a similar mean length of stay (16.9 days versus 17.7 days; p = 0.0669), had lower mean hospitalization cost (24,382 dollars versus 30,537 dollars; p < 0.0001), were less likely to be admitted to the intensive care unit (37% versus 56%; p < 0.0001), and had a greater mortality (29% versus 20%; p < 0.0001) than those without HIV/AIDS. After adjustment for cohort differences, patients with severe sepsis and HIV/AIDS had increased likelihood of death (OR (95% CI) = 2.41 (2.23-2.61)) and were substantially less likely to be admitted to the intensive care unit (OR (95% CI) = 0.54 (0.51-0.59)). When compared with those with severe sepsis and HIV/AIDS, patients with severe sepsis without HIV/AIDS were universally more likely to be admitted to the intensive care unit, even when they had comorbid illnesses with equal or worse expected in-hospital mortality (e.g., metastatic cancer). CONCLUSION: For patients with severe sepsis, there are differences in care and outcomes for those with HIV/AIDS. Further research is needed to examine the delivery of care for patients with severe sepsis and HIV/AIDS.

Severe sepsis in managed care: analysis of incidence, one-year mortality, and associated costs of care.

OBJECTIVE: To determine severe sepsis (SS) incidence, hospital mortality, 1-year mortality, and costs associated with care in a sample of enrollees in a nationally representative individual practice association (IPA)-network managed care organization (MCO). METHODS: This was a retrospective analysis of administrative claims data for commercial (not managed Medicare) members. We identified MCO members hospitalized for SS between July 1995 and December 1998. SS cases were identified by a combination of ICD-9-CM codes for infection and organ dysfunction. Enrollment information, physician, facility, and pharmacy claims were analyzed. Subjects with continuous enrollment were followed for 1 full year of observation. Costs were health plan payments to providers, after subtraction of member cost-share amounts. RESULTS: The incidence rate was 0.91 cases of SS per 1,000 enrollees, increasing with age. The mean age of SS patients was 50 years, and 53% were male. Approximately 63% received surgical intervention. Mortality was 21% during the first hospitalization and 36.1% at 1 year. During follow-up, 47.1% of survivors were rehospitalized. Mean index hospitalization length of stay and costs were 16 days and 26,820 dollars, with 1-year inpatient and outpatient costs totaling 48,996 dollars. Mean outpatient costs per survivor were 8,363 dollars, and mean per-patient-per-month (PPPM) outpatient costs were 906 dollars. Total follow-up costs including rehospitalization were similar for nonsurvivors compared with survivors (7,710 dollars versus 8,522 dollars, P=0.274), but PPPM costs were higher for nonsurvivors (1,760 dollars versus 699 dollars, P<0.001). CONCLUSIONS: Incidence, hospital, and 1-year mortality rates were lower in this population compared with literature reports and were associated with a lower average age in this managed care population. Mean SS hospitalization costs were high, and nearly one half of survivors required rehospitalization within 1 year. Study results suggest the need to evaluate SS interventions for improvement in health outcomes and cost outcomes, particularly in postsurgical patients.

Components of Medicare reimbursement.

The history of the Medicare reimbursement system, how it works, and issues related to fraud and abuse are discussed. The statutory charge of Medicare is to ensure adequate reimbursement through a Prospective Payment System (PPS) to cover the costs for providing a given service to Medicare beneficiaries. The PPS was introduced as a way to change hospital behavior through financial incentives that encourage cost-efficient management of resources. The system utilizes a rate of payment in which a hospital is paid a fixed amount that is expected to cover the costs of care while treating a typical patient in a particular diagnosis-related group (DRG). The PPS uses DRGs as payment categories and Major Diagnostic Categories (MDCs) for classifying the DRGs into similar groupings. One of the first steps in DRG assignment is identification of the principal diagnosis represented by an International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) code. The secondary diagnoses (referred to as complications or comorbidities), presence or absence of surgery, age of the patient, and discharge status are the other pieces of information making up assignment of a specific DRG to a patient. A basic knowledge of the Medicare program will help in the understanding of how hospitals will be reimbursed for patient care, as well as how changes in Medicare payment may affect reimbursement. Medicare is one of the largest health insurance providers in the United States. A basic understanding of the Medicare system will provide valuable insights into Medicare reimbursement and the influence it has on a hospital's bottom line.

Billing for inpatient hospital care.

Pharmacy personnel billing patients for services rendered is discussed. Billing for services is a critical function for maintaining the financial viability of health care institutions. Poor understanding of the system can lead to incorrect documentation, which can result in a claim rejection. The UB-92 provides hospitals with the proper format to request reimbursement for services provided. To ensure proper reimbursement, appropriate coding of International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) codes for diagnosis, procedures, and services provided is necessary. Ancillary services, such as pharmacy, play a crucial role in the completion of the bill by ensuring that the charge-master accurately represents the service provided. This information includes identification, charge, cost, and revenue codes. Hospital billing agents must also account for any outpatient visits that may have occurred within three days of admission, since these charges may need to be included on the hospital bill. In order for the billing process to be effective, it is important that all personnel have a thorough understanding of the billing process and be able to effectively communicate with each other.

The relation of body mass index, cardiorespiratory fitness, and all-cause mortality in women.

OBJECTIVE: To examine the relation of body mass index (BMI), cardiorespiratory fitness (CRF), and all-cause mortality in women. RESEARCH METHODS AND PROCEDURES: A cohort of women (42.9 +/- 10.4 years) was assessed for CRF, height, and weight. Participants were divided into three BMI categories (normal, overweight, and obese) and three CRF categories (low, moderate, and high). After adjustment for age, smoking, and baseline health status, the relative risk (RR) of all-cause mortality was determined for each group. Further multivariate analyses were performed to examine the contribution of each predictor (e.g., age, BMI, CRF, smoking status, and baseline health status) on all-cause mortality while controlling for all other predictors. RESULTS: During follow-up (113,145 woman-years), 195 deaths from all causes occurred. Compared with normal weight (RR = 1.0), overweight (RR = 0.92) and obesity (RR = 1.58) did not significantly increase all-cause mortality risk. Compared with low CRF (RR = 1.0), moderate (RR = 0.48) and high (RR = 0.57) CRF were associated significantly with lower mortality risk (p = 0.002). In multivariate analyses, moderate (RR = 0.49) and high (RR = 0.57) CRF were strongly associated with decreased mortality relative to low CRF (p = 0.003). Compared with normal weight (RR = 1.0), overweight (RR = 0.84) and obesity (RR = 1.21) were not significantly associated with all-cause mortality. DISCUSSION: Low CRF in women was an important predictor of all-cause mortality. BMI, as a predictor of all-cause mortality risk in women, may be misleading unless CRF is also considered.