Vesicoureteral Reflux Treatment by Endoscopic Injection of Bulking Agents
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Defines Aetna's coverage and medical necessity criteria for endoscopic injection of FDA‑approved bulking agents (e.g., Deflux, Macroplastique, Teflon) to treat primary or secondary VUR in pediatric and other members, and lists agents considered experimental/investigational.
No material clinical or coverage changes in this revision.
Coverage Criteria for Endoscopic Injection of Bulking Agents
Medical Necessity Indications
Covered when ANY of the following are met and conservative treatments have failed:
Conservative treatments include prophylactic antibiotics and clean intermittent catheterization.
Treatment Failure Criterion
Failure definition:
General coverage considerations
Evidence-based considerations influencing choice of endoscopic injection versus open repair:
Supported by comparative studies and reviews (prospective and retrospective series).
Agent-specific safety consideration
When considering PPC (Vantris):
Monitor for obstruction 1–3 years post-injection; balance higher single‑injection success against obstruction risk.
Efficacy by agent and VUR grade
Efficacy evidence to inform coverage decisions:
Evidence from cohort studies, prospective comparisons and meta-analyses; higher‑grade VUR tends to have lower endoscopic success compared with re-implantation.
Coverage considerations and clinical criteria
Coverage considerations and clinical signals from the cited literature:
Effectiveness varies by agent and patient population (transplant vs primary pediatric).
Meta-analyses report pooled odds ratios favoring PPC for resolution but also report higher UVJO in some cohorts.
Studies of pediatric primary VUR and transplant populations show differing radiologic versus clinical outcomes and should inform patient selection.
Multiple studies report imaging at ~3 months and longer‑term follow‑up; obstruction after injection has led to re‑implantation in some cases.
Aetna considers endoscopic injections of the following materials experimental and investigational for treatment of vesicoureteral reflux because their effectiveness has not been established: autologous blood; calcium hydroxyapatite; chondrocytes; Durasphere (DEXP); fat; glutaraldehyde cross‑linked bovine dermal collagen (Contigen/Zyplast); myoblasts; polyacrylamide hydrogel (Bulkamid); and polyacrylate‑polyalcohol copolymer (Vantris).
Durasphere (DEXP) has been reported in a small, preliminary pediatric series with short‑term radiologic success (84.2% at first VCUG) but declining durability at 1 year (69.4%); the authors concluded these are early findings that require validation in well‑designed studies, and UpToDate does not list Durasphere as a management option, indicating limited endorsement in current reviews.
Case series and a systematic review report high rates of ureteral obstruction and suboptimal radiologic resolution after endoscopic injection in pediatric renal transplant ureters; the transplanted ureter’s non‑orthotopic anatomy and lack of a submucosal tunnel may contribute to poor outcomes and a greater likelihood of needing stenting or open ureteroneocystostomy when injection fails.
Members whose condition does not improve after 3 treatment sessions of endoscopic injection are considered treatment failures; if there is no clinical or radiologic improvement within 3 sessions, additional endoscopic injections are not medically necessary.
Comparative studies report that endoscopic injection with dextranomer/hyaluronic acid (Dx/HA) generally achieves lower radiologic resolution than open ureteral re‑implantation for higher‑grade VUR (grades IV–V); therefore, for high‑grade VUR where maximal radiologic correction is the clinical priority, open re‑implantation may be the preferred definitive treatment over Dx/HA injection.
A systematic review of Deflux (Dx/HA) for pediatric post‑transplant VUR found a mean success rate of 36.8% and ureteral obstruction in 10.4% (7/67) of cases; because of these low success rates and notable obstruction risk, endoscopic injection alone with Deflux may be insufficient and is not routinely the preferred definitive therapy in many pediatric transplant patients.
Coding and Billing
| 52327 | Cystourethroscopy (including ureteral catheterization); with subureteric injection of implant material. |
| 51715 | Endoscopic injection of implant material into the submucosal tissue of the urethra and/or bladder neck. |
| 74420 | Urography, retrograde, with or without KUB. |
| 74450 | Urethrocystography, retrograde, radiological supervision and interpretation. |
| 74455 | Urethrocystography, voiding, radiological supervision and interpretation. |
| 78740 | Ureteral reflux study (radiopharmaceutical voiding cystogram). |
| N13.70 - N13.9 | Vesicoureteral-reflux |
| No codes listed |
Provider Requirements, Prior Authorization, and Documentation
Authorization notes: pre-procedure grading and post-op imaging
Prior authorization may be required and is tied to medical necessity. Document the pre-procedure VUR grade and the planned bulking agent (e.g., Deflux, Macroplastique, PPC) when requesting authorization. Post-operative imaging plans should be specified (voiding cystourethrogram [VCUG] at approximately 3 months is standard; renal ultrasound often at 3 months and 1 year).
- Pre-procedure: record VUR grade and intended agent
- Post-op imaging: VCUG ~3 months; renal ultrasound commonly at ~3 months and ~1 year
Prior authorization recommended for post-transplant and pediatric VUR injections
Prior authorization is recommended for endoscopic injection procedures in special populations (e.g., post-renal-transplant patients and pediatric post-transplant VUR cases) due to variable success rates and higher risk of complications such as ureteral obstruction.
- Post-transplant VUR: variable radiologic and clinical success; higher obstruction risk reported
- Pediatric transplant recipients: lower pooled success and notable obstruction rates — consider prior review
Treatment failure after 3 sessions
If a member does not improve after three treatment sessions, they are considered a treatment failure and further endoscopic injections are not considered medically necessary.
- Limit: no additional injections beyond 3 unsuccessful sessions
Potential denial trigger: poor documented radiologic/clinical response
Claims may be denied or require further review when there is poor or absent documented radiologic or clinical response to prior injections (e.g., lack of documented VUR resolution on VCUG or continued symptomatic/recurrent febrile UTIs). Ensure clear documentation of clinical benefit.
- Missing or negative post-op VCUG documenting persistent VUR
- Ongoing febrile UTIs without documented treatment response
Obstruction risk may trigger denial or further review
Document and monitor for uretero-vesical junction obstruction (UVJO) or other obstruction after certain agents (notably PPC/Vantris); presence or high risk of obstruction may prompt denial, request for additional interventions, or further clinical review.
- Late UVJO has been reported after PPC with requirement for re-implantation in some cases
- Document plans for long-term follow-up and management of suspected obstruction
Authorization/Denial notes
Authorization and denial decisions are based on the documented clinical indications, imaging results, prior therapies, and policy criteria. Providers should reference the Clinical Policy Bulletin and recent policy history when submitting requests.
- Reference Clinical Policy Bulletin for full documentation requirements and CPT/HCPCS lists
- Policy effective date and review history may be considered during review
Required documentation: post-op VCUG and ultrasound
Required documentation includes radiologic evidence of VUR pre-procedure (e.g., VCUG), records of symptomatic UTIs, prior conservative therapy attempts, and post-operative imaging. Specifically, a post-operative VCUG at about 3 months and renal ultrasound follow-up (often at ~3 months and ~1 year) should be provided.
- Pre-procedure: VCUG documenting VUR grade; clinical history of febrile UTIs
- Post-procedure: VCUG ~3 months showing resolution or persistent reflux
- Renal ultrasound: commonly at ~3 months and ~1 year as applicable
Required clinical documentation
Clinical documentation should include radiologic confirmation of VUR and grading, history and frequency of symptomatic or febrile UTIs, details of prior conservative management and responses, and operative notes describing injected agent and volumes.
- VCUG reports with VUR grade
- UTI episode documentation (dates, cultures, treatments)
- Evidence of failed conservative therapy (antibiotic prophylaxis, CIC)
- Operative note: agent, volume, technique, laterality
Documentation and policy history
Providers should consult the policy history and Clinical Policy Bulletin for the complete set of documentation, coding lists, and any updates; review dates and past revisions are relevant to authorization decisions.
- See Clinical Policy Bulletin for full documentation checklist and code lists
- Check policy review dates (Effective 08/21/2001; last review noted) for current criteria
Conservative therapy first in many pediatric cases
Conservative therapy (e.g., prophylactic antibiotics, observation, clean intermittent catheterization) should generally be attempted first in many pediatric cases; endoscopic injection is appropriate when conservative measures have failed or per listed indications (and may be first-line for select low-grade cases per clinician judgment and policy criteria).
- Conservative measures must be documented as tried and failed unless policy-listed exceptions apply
- Endoscopic injection may be considered first-line for lower-grade VUR in select situations
Step therapy
The policy does not specify additional formal step-therapy requirements beyond the expectation that conservative treatments be attempted and documented; include prior therapy details in requests to expedite review.
- No other step-therapy protocols specified in these policy excerpts
- Document prior conservative therapy to demonstrate medical necessity
Background and Rationale
Vesicoureteral reflux (VUR) is predominantly a childhood disorder in which urine refluxes from the bladder to the kidneys, increasing risk of urinary tract infections and renal scarring. Reflux is graded I–V by voiding cystourethrogram (Grades I–V), and treatment selection balances spontaneous resolution (more likely with lower grades), infection risk, renal function considerations, and the tradeoffs between minimally invasive endoscopic injection and open ureteral re‑implantation.
Definitions and Key Terms
Policy Revision History
Policy last reviewed on 08/08/2023; status recorded as current with next scheduled review on 06/13/2024.
Policy originally became effective on 08/21/2001.
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