Integrated renal care: are nephrologists ready for change in renal care delivery models?

The Affordable Care Act is the most visible element of health care reform. However, both before the Affordable Care Act and now with the acceleration since its passage, the Centers for Medicare and Medicaid have been and are testing integrated care models in medicine in general as well as nephrology. The pressures to do so come from the well known increasing costs of health care in the face of a number of clear gaps in quality. The future will likely be more and more integrated care with less and less fee for service. More measurement of quality and the linking of quality measures to payments are also all but certain future elements of the health care economy. Nephrologists need to educate themselves on these trends and be prepared to engage them for the good of the profession and the improvement in care for patients.

Considering an integrated nephrology care delivery model: six principles for quality.

In 2012, 27 organizations will initiate participation in the Medicare Shared Savings Program as Accountable Care Organizations. This level of participation reflects the response of Centers for Medicare and Medicaid Services to criticism that the program as outlined in the proposed rule was overly burdensome, prescriptive, and too risky. Centers for Medicare and Medicaid Service made significant changes in the final rule, making the Accountable Care Organization program more attractive to these participants. However, none of these changes addressed the serious concerns raised by subspecialty societies-including the American Society of Nephrology-regarding care of patients with multiple chronic comorbidities and complex and end stage conditions. Virtually all of these concerns remain unaddressed, and consequently, Accountable Care Organizations will require guidance and partnership from the nephrology community to ensure that these patients are identified and receive the individualized care that they require. Although the final rule fell short of addressing the needs of patients with kidney disease, the Centers for Medicare and Medicaid Innovation presents an opportunity to test the potentially beneficial concepts of the Accountable Care Organization program within this patient population. The American Society of Nephrology Accountable Care Organization Task Force developed a set of principles that must be reflected in a possible pilot program or demonstration project of an integrated nephrology care delivery model. These principles include preserving a leadership role for nephrologists, encompassing care for patients with later-stage CKD and kidney transplants as well as ESRD, enabling the participation of a diversity of dialysis provider sizes and types, facilitating research, and establishing monitoring systems to identify and address preferential patient selection or changes in outcomes.

Serum alkaline phosphatase and phosphate and risk of mortality and hospitalization.

BACKGROUND AND OBJECTIVES: Elevated alkaline phosphatase (AlkPhos) and phosphate levels are associated with cardiovascular morbidity and mortality in patients receiving dialysis. A retrospective cohort study was conducted to test these associations in outpatients with an estimated GFR > or =60 ml/min/1.73 m(2). DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Patients with serum AlkPhos and phosphate levels measured between 2000 and 2002 (n = 10,743) at Montefiore Medical Center (MMC) clinics were followed through September 11, 2008 (median 6.8 years). Mortality data were obtained via Social Security Administration records (n = 949 deaths). Hospitalization data were obtained from MMC records. RESULTS: The mean age was 51 years, 64% were women, 22% were white, 26% were non-Hispanic black, 16% were Hispanic, 13% had a diagnosis of hypertension, 9% had diabetes mellitus, and 8% had cardiovascular disease at baseline. AlkPhos and phosphate were independently associated with mortality and cardiovascular-related hospitalization after multivariable adjustment. Comparing patients in the highest (> or =104 U/L) versus lowest quartile of AlkPhos (< or =66 U/L), the adjusted hazard ratio (HR) for mortality was 1.65 (P trend across quartiles <0.001). For the highest compared with the lowest quartile of serum phosphate (> or =3.8 mg/dl versus < or =3.0 mg/dl), the adjusted HR for mortality was 1.29 (P trend across quartiles = 0.008). High AlkPhos but not phosphate levels were also associated with all-cause, infection-related, and fracture-related hospitalization. CONCLUSIONS: Higher levels of serum AlkPhos and phosphate were associated with increased mortality and cardiovascular-related hospitalization in an inner-city clinic population. Further studies are needed to elucidate mechanisms underlying these associations.

Proteinuria as a surrogate outcome in CKD: report of a scientific workshop sponsored by the National Kidney Foundation and the US Food and Drug Administration.

Changes in proteinuria have been suggested as a surrogate outcome for kidney disease progression to facilitate the conduct of clinical trials. This report summarizes a workshop sponsored by the National Kidney Foundation and US Food and Drug Administration (FDA) with the following goals: (1) to evaluate the strengths and limitations of criteria for assessment of proteinuria as a potential surrogate end point for clinical trials in chronic kidney disease (CKD), (2) to explore the strengths and limitations of available data for proteinuria as a potential surrogate end point, and (3) to delineate what more needs to be done to evaluate proteinuria as a potential surrogate end point. We review the importance of proteinuria in CKD, including the conceptual model for CKD, measurement of proteinuria and albuminuria, and epidemiological characteristics of albuminuria in the United States. We discuss surrogate end points in clinical trials of drug therapy, including criteria for drug approval, the definition of a surrogate end point, and criteria for evaluation of surrogacy based on biological plausibility, epidemiological characteristics, and clinical trials. Next, the report summarizes data for proteinuria as a potential surrogate outcome in 3 broad clinical areas: early diabetic kidney disease, nephrotic syndrome, and diseases with mild to moderate proteinuria. We conclude with a synthesis of data and recommendations for further research. At the present time, there appears to be sufficient evidence to recommend changes in proteinuria as a surrogate for kidney disease progression in only selected circumstances. Further research is needed to define additional contexts in which changes in proteinuria can be expected to predict treatment effect. We recommend collaboration among many groups, including academia, industry, the FDA, and the National Institutes of Health, to share data from past and future studies.

Detection of chronic kidney disease in patients with or at increased risk of cardiovascular disease: a science advisory from the American Heart Association Kidney And Cardiovascular Disease Council; the Councils on High Blood Pressure Research, Cardiovascular Disease in the Young, and Epidemiology and Prevention; and the Quality of Care and Outcomes Research Interdisciplinary Working Group: developed in collaboration with the National Kidney Foundation.

Chronic kidney disease (CKD) occurs commonly in patients with cardiovascular disease. In addition, CKD is a risk factor for the development and progression of cardiovascular disease. In this advisory, we present recommendations for the detection of CKD in patients with cardiovascular disease. CKD can be reliably detected with the combined use of the Modification of Diet in Renal Disease equation to estimate glomerular filtration rate and a sensitive test to detect microalbuminuria. All patients with cardiovascular disease should be screened for evidence of kidney disease with these two determinations.

Chronic kidney disease: a public health problem that needs a public health action plan.

For a health problem or condition to be considered a public health issue, four criteria must be met: 1) the health condition must place a large burden on society, a burden that is getting larger despite existing control efforts; 2) the burden must be distributed unfairly (i.e., certain segments of the population are unequally affected); 3) there must be evidence that upstream preventive strategies could substantially reduce the burden of the condition; and 4) such preventive strategies are not yet in place. Chronic kidney disease meets these criteria for a public health issue. Therefore, as a complement to clinical approaches to controlling it, a broad and coordinated public health approach will be necessary to meet the burgeoning health, economic, and societal challenges of chronic kidney disease.