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Clinical Policy Bulletin:
RenalVysion
Number: 0775


Policy

Aetna considers the RenalVysion test (Nephrocor, Glen Allen, VA) for diagnosing and monitoring kidney disease experimental and investigational because of insufficient evidence of its effectiveness.



Background

An estimated 7 % of adults aged 20 or older (15.5 million adults) have physiological evidence of chronic kidney disease (CKD) as defined by a moderately or severely reduced glomerular filtration rate (GFR) (Coresh et al, 2007).  Patients with kidney disease have a variety of different clinical presentations.  Some have symptoms that are directly referable to the kidney (e.g., gross hematuria, flank pain) or to extra-renal sites of involvement (e.g., edema, hypertensive, signs of uremia).  Many patients, however, lack specific symptoms and are noted on routine examination to have an elevated plasma creatinine concentration or an abnormal urinalysis.

According to the National Institute for Clinical Excellence (NICE, 2008), 30 % of people with advanced kidney disease are referred late to nephrology services causing increased mortality and morbidity.  Strategies aimed at earlier identification and, where possible, prevention of progression to established renal failure are needed.

The National Kidney Foundation practice guidelines on CKD (2002) recommended identifying persons at increased risk for CKD to include persons with diabetes, hypertension, those with a family history of CKD, age greater than 60 years, and those with United States racial or ethnic minority status.  The guidelines stated that kidney damage can be detected by measuring the albumin-creatinine ratio in un-timed ("spot") urine specimens, and estimating the GFR from serum creatinine measurements by using prediction equations.  The estimated GFR comes from a formula that combines the creatinine level with the patient's age, race and gender.  Chronic kidney disease is defined as the presence of kidney damage or level of GFR less than 60 ml/min per 1.73 m2 that is present for 3 or more months.

The indications for performing a renal biopsy varies among nephrologists, being determined in part by the presenting signs and symptoms.  A percutaneous renal biopsy is sometimes performed to obtain a diagnosis, help guide therapy, and ascertain the degree of active and chronic changes.  The routine evaluation of a percutaneous renal biopsy involves examination of the tissue under light, immunofluorescence, and electron microscopy. 

RenalVysion (Nephrocor, Glen Allen, VA), a urine-based test that integrates urine cytopathlogy with urine chemistries (i.e., creatinine, protein, beta-2 microglobulin, microalbumin), is being marketed as a 'liquid biopsy' for the early diagnosis and monitoring of kidney disease.  However, there are no published studies on the use of RenalVysion for kidney disease and no medical professional society recommends RenalVysion testing for diagnosing and monitoring kidney disease.  Chronic kidney disease can be readily detected with tests for proteinuria, hematuria, and estimated GFR.  Randomized controlled studies comparing RenalVysion to these standard methods for diagnosing and monitoring kidney disease are needed.

 
CPT Codes / HCPCS Codes / ICD-9 Codes
There are no specific codes for RenalVysion:
ICD-9 codes not covered for indications listed in the CPB (not all-inclusive):
401.0 - 405.99 Hypertensive disease
585.1 - 585.9 Chronic kidney disease (CKD)
586 Renal failure, unspecified
599.71 Gross hematuria
782.3 Edema
789.00 - 789.09 Abdominal pain


The above policy is based on the following references:
  1. Coresh J, Selvin E, Stevens LA, et al. Prevalence of chronic kidney disease in the United States. JAMA. 2007;298(17):2038-2047.
  2. Post TW, Rose BD. Urinalysis in the diagnosis of renal disease. UpToDate [online serial]. Waltham, MA: UpToDate; 2008.
  3. Stevens L, Perrone RD. Assessment of kidney function: Serum creatinine; BUN; and GFR. UpToDate [online serial]. Waltham, MA: UpToDate; 2008.
  4. Whittier WL, Korbet SM. Indications for and complications of renal biopsy. UpToDate [online serial]. Waltham, MA: UpToDate; 2008.
  5. Nephrocor [website]. RenalVysion. Glen Allen, VA. 2008. Available at: http://www.nephrocor.com/Global/services/laboratory-services/renalvysion.aspx. Accessed October 31, 2008.
  6. National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: Evaluation, classification, and stratification. National Kidney Foundation. New York, NY; 2002. Available at: http://www.kidney.org/PROFESSIONALS/kdoqi/guidelines_ckd/p9_approach.htm. Accessed November 3, 2008.
  7. U.S. Department of Health & Human Services. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). National Kidney Disease Education Program. Chronic kidney disease (CKD) information for health professionals. December 28, 2005. Available at: http://www.nkdep.nih.gov/professionals/chronic_kidney_disease.htm#definition. Accessed November 3, 2008.
  8. National Institute for Clinical Excellence (NICE). Chronic kidney disease: Early identification and management of chronic kidney disease in adults in primary and secondary care. NICE clinical guideline 73. London, UK: NICE; September 2008. Available at: http://www.nice.org.uk/nicemedia/pdf/CG073NICEGuideline.pdf. Accessed November 3, 2008.
  9. Scottish Intercollegiate Guidelines Network (SIGN). Diagnosis and management of chronic kidney disease. A national clinical guideline. Edinburgh, Scotland: Scottish Intercollegiate Guidelines Network (SIGN); 2008.
  10. Joint Specialty Committee on Renal Medicine of the Royal College of Physicians and The Renal Association, and the Royal College of General Practitioners. Identification,management and referral of adults with chronic kidney disease. Guidelines for general physicians and general practitioners. Concise guidance to good practice, No 5. London: RCP, 2006.
  11. Kidney Health Australia. Chronic kidney disease (CKD) management in general practice. Kidney Health Australia, Melbourne, VIC. 2007.
  12. Eknoyan G, Hostetter T, Bakris GL, et al. Proteinuria and other markers of chronic kidney disease: A position statement of the National Kidney Foundation (NKF) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Am J Kidney Dis. 2003;42(4):617-622.
  13. Levey AS, Coresh J, Balk E, et al; National Kidney Foundation. National Kidney Foundation practice guidelines for chronic kidney disease: Evaluation, classification, and stratification. Ann Intern Med. 2003;139(2):137-147.
  14. Canadian Agency for Drugs and Technologies in Health (CADTH). Liquid biopsy for the detection of renal disease. Emerging Issues in Diagnostic Technology. Health Technology Update. Issue 12. Ottawa, ON: CADTH; November 2009.


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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