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DESCRIPTIONVesicoureteral reflux (VUR) is the retrograde flow of urine from the bladder upward toward the kidney and is most commonly seen in children. The primary management strategies have been prophylactic antibiotics to reduce urinary tract infections and, for higher grade disease, surgical correction of the underlying reflux. Injection of periureteral bulking agents is proposed as an alternative to surgical intervention.
Treatment of vesicoureteral reflux (VUR) is based on the assumption that VUR predisposes patients to urinary tract infections (UTIs) and renal infection (pyelonephritis) by facilitating the transport of bacteria from the bladder to the upper urinary tract. Pyelonephritis causes renal scarring in as many as 40% of children, and extensive scarring may lead to renal insufficiency and hypertension. The period between first renal scarring from pyelonephritis and the development of hypertension or end-stage renal disease can be 30–40 years.
In most cases, VUR is diagnosed during evaluation of UTIs. About one third of children with UTIs are found to have VUR. The average age for the onset of UTI is 2–3 years, corresponding to the age when toilet training occurs. There also appears to be a genetic predisposition to VUR, and siblings may also be examined. The criterion standard for diagnosis is voiding cystourography, a procedure which involves catheterization of the bladder. The severity of reflux is described by a grade, typically with the International Reflux Study Group grading system, which grades severity from I (reflux partway up the ureter) to V (massive reflux of urine up the ureter with marked tortuosity and dilation of the ureter and calyces). Determination of VUR grade is not exact, however, due to factors such as bladder pressure, which may vary at the time of measurement. In general, more severe reflux is associated with higher rates of renal injury, and less severe reflux (i.e., grade I and II) is associated with higher rates of spontaneous resolution and treatment success. Other factors that have been found to be associated with the likelihood of spontaneous resolution of VUR and/or renal injury include age, sex, laterality, presence of renal scars, presence of voiding dysfunction, and history of urinary tract infection.
Treatment strategies for VUR include bladder training, antibiotic prophylaxis, and surgical modification of the ureter to correct the underlying reflux. VUR is likely to resolve spontaneously over a period of 1- 5 years; lower grades of reflux (i.e., grades I and II) are associated with a higher probability of spontaneous resolution. The decision to administer prophylactic antibiotic treatment includes the consideration of potential adverse effects of long-term antibiotic treatment, which can include allergic reactions and development of treatment-resistant bacteria resulting in breakthrough UTIs.
Open surgical treatment is typically reserved for patients with high-grade reflux (grades III and IV) or as salvage therapy for those who are noncompliant with antibiotic therapy or have breakthrough UTIs while receiving prophylactic therapy. Surgical management involves lengthening the intramural ureter by modification of the ureterovesical attachment with reimplantation of the ureter. Success rates for open surgery are reported to be above 95%, and nearly 100% for patients with lower grades of reflux. In recent years, there have been advances in surgical technique, including use of a lower abdominal transverse incision that leaves a smaller scar. Combined with a reduction in the use of ureteral stents and prolonged catheterization; the changes have led to shorter hospital stays and reduced surgery-related morbidity. Moreover, surgeries can now be done on an outpatient basis. Surgery, however, still involves risks associated with anesthesia and potential complications such as ureteral obstruction, infection, and bleeding. Some centers have reported using laparoscopic antireflux surgery, but this is technically difficult and has not become widespread. Robotic-assisted laparoscopic methods are being developed to overcome some of the technical difficulties.
Treatment of VUR remains controversial. There is a lack of good evidence that VUR actually increases the risk of pyelonephritis and renal scarring, and the long period of time before renal scarring, hypertension, and end-stage renal disease makes these serious conditions difficult to study. Moreover, VUR has a relatively high rate of spontaneous resolution, more than 60% over 5 years, so many children may not benefit from treatment. An important challenge is to identify the subset of children most likely to benefit from VUR treatment. At present, in the absence of definitive answers on the utility of treating VUR or the best treatment option, antibiotic prophylaxis to prevent recurrent UTIs and surgery to treat the underlying reflux remain accepted management strategies.
The use of bulking agents in the treatment of VUR has been reported for over 20 years and has been suggested as an alternative to either antibiotic or surgical therapy. Bulking agents can be injected into tissue around the ureteral orifices to minimize reflux. The STING procedure (subureteral trans-urethral injection) involves the endoscopic injection of a bulking agent into the submucosal bladder wall just below the ureteral opening. In the more recently used modified STING procedure, the needle is placed in the ureteral tunnel, and the bulking agent is injected into the submucosal intraureteral space. When successfully injected, the compound tracks along the length of the detrusor tunnel and establishes a coapted ureteral tunnel. This endoscopic procedure can be performed in an outpatient setting.
A variety of bulking agents have been tested for biocompatibility and absence of migration. Some of the compounds used in clinical studies are collagen (Contigen®, Zyderm®, Zyplast®), polytetrafluoroethylene paste (Teflon), polydimethylsiloxane (Macroplastique®), calcium hydroxyapatite (Coaptite®), dextranomer/hyaluronic acid copolymer (Deflux® or Dx/HA), and polyacrylamide hydrogel (Bulkamid®).
In 2001, Deflux® received pre-market approval from the U.S. Food and Drug Administration (FDA) for the “treatment of children with vesicoureteral reflux (VUR) grades II-IV.” Contraindications include patients with non-functioning kidney(s), active voiding dysfunction, and ongoing urinary tract infection. Duplicated ureters were initially considered a contraindication to Deflux treatment, but this was changed to a precaution in 2007.
Note: Polytetrafluoroethylene may migrate, causing serious adverse events; this agent is not FDA-approved. Coaptite®, Macroplastique®, and Tegress® are categorized by the FDA as “Agent, Bulking, Injectable For Gastro-Urology Use.” Tegress was voluntarily withdrawn from the market by CR Bard on January 31, 2007. These are currently indicated for the treatment of stress urinary incontinence and are discussed in the Periurethral Bulking Agents for the Treatment of Urinary Incontinence.
POLICYPeriureteral bulking agents may be considered medically necessary as a treatment of vesicoureteral reflux grades II–IV when medical therapy has failed and surgical intervention is otherwise indicated.
The use of bulking agents as a treatment of vesicoureteral reflux in other clinical situations is considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
The use of bulking agents is contraindicated in patients with non-functioning kidney(s), hutch diverticuli, active voiding dysfunction, and ongoing urinary tract infection.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY5/8/2008: Policy added
07/30/2010: Policy description updated regarding new treatment approaches. Medically necessary policy statement revised to add “when medical therapy has failed" and to delete the word “open” before surgical intervention. FEP verbiage added to the Policy Exceptions section. Added definition of investigative services to the policy guidelines. Added bulking agent HCPCS codes L8603, L8604, and L8606.
12/30/2010: Policy reviewed; no changes.
12/01/2011: Policy reviewed; no changes.
12/13/2013: Policy reviewed; no changes to policy statement. Deleted duplicated ureter as a contraindication in the policy guidelines.
12/05/2014: Policy reviewed; description updated. Policy statements unchanged.
08/31/2015: Medical policy revised to add ICD-10 codes.
12/01/2015: Policy description updated regarding bulking agents. Policy statements unchanged. Policy guidelines updated to add medically necessary and investigative definitions.
05/31/2016: Policy number added.
SOURCE(S)Blue Cross & Blue Shield Association Policy # 7.01.102
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.