CurrentAetnaPolicy 0534

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.

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CurrentAetnaPolicy 0534

Vesicoureteral Reflux Treatment by Endoscopic Injection of Bulking Agents

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Policy Summary

PayerAetna

PolicyVesicoureteral Reflux Treatment by Endoscopic Injection of Bulking Agents

Policy CodePolicy 0534

Change TypeAnnual review

Effective DateAug 21, 2001

Last ReviewAug 8, 2023

Next Review DateJun 13, 2024

Key ActionDocument preoperative VUR grade, prior conservative therapy failure, and planned bulking agent; obtain postoperative VCUG at ~3 months to confirm radiologic success.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3treatment failure threshold

I–VVUR grades

L8604 / 52327Representative HCPCS/CPT

~75 refsbibliography

78%infection reduction (transplant)

Coverage Criteria for Endoscopic Injection of Bulking Agents

Medical Necessity Indications

Covered when ANY of the following are met and conservative treatments have failed:

Medical necessity indications: 1) Children who have had a previously unsuccessful ureteral re-implantation; OR 2) Children who have stopped taking their medication as a result of drug intolerance or parental non-compliance; OR 3) Children whose reflux is associated with a thick-walled neuropathic bladder; OR 4) Deterioration of renal parameters regardless of reflux severity; OR 5) Lower grades of reflux (grades I to III); OR 6) Persistent reflux in post-pubertal female members; OR 7) Recurrent, poorly controlled febrile urinary tract infections; OR 8) Symptomatic VUR after renal transplantation.conservative therapy failure required

Conservative treatments include prophylactic antibiotics and clean intermittent catheterization.

Treatment Failure Criterion

Failure definition:

Treatment failure: Members whose condition does not improve after 3 treatment sessions are considered treatment failures and further treatments are not considered medically necessary.3 sessions

General coverage considerations

Evidence-based considerations influencing choice of endoscopic injection versus open repair:

Coverage considerations: Endoscopic injection can be effective (success varies by agent and VUR grade); it may be considered first-line surgical option for lower-grade VUR and for patients where a minimally invasive approach is preferred; open ureteral re-implantation has higher resolution rates for higher-grade VUR or after failed endoscopic injection.

Supported by comparative studies and reviews (prospective and retrospective series).

Agent-specific safety consideration

When considering PPC (Vantris):

PPC safety: PPC (polyacrylate‑polyalcohol copolymer; Vantris) demonstrates high initial resolution rates in several series but is associated with a measurable risk of late uretero‑vesical junction obstruction (reported e.g., ~6.2% of renal refluxing units or ~8% of children in cohorts), requiring long-term follow-up and in some cases ureteral re-implantation or stenting.

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:

Efficacy highlights: Dextranomer/hyaluronic acid (Dx/HA; Deflux) demonstrates variable radiologic and clinical success (e.g., ~81.5% radiologic success after first injection in one cohort) with some relapse over time; polydimethylsiloxane (Macroplastique) showed higher correction in a prospective comparison (90% vs 81% for Dx/HA); PPC/PCP shows higher single‑injection success in meta-analyses (e.g., 86% vs 69% for Dx/HA) but with differing complication profiles. Choice of agent and patient selection (VUR grade, age, transplant status) materially influences success and durability.

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:

Use cases with supportive evidence: Endoscopic injection has reported clinical success as a minimally invasive option for symptomatic VUR after renal transplantation and in pediatric patients, with clinical and radiologic success rates varying widely by study and population (examples include clinical success ~56% in a mixed transplant series, reduced infections post‑injection in transplant cohorts, and single‑injection success for PCP reported near 86% in pooled analyses).

Effectiveness varies by agent and patient population (transplant vs primary pediatric).

Agent-specific tradeoffs: Dx/HA (Deflux) generally has lower obstruction risk but may have lower durability/long‑term radiologic success in some settings (notably pediatric post‑transplant); PPC/PCP and polydimethylsiloxane may have higher single‑injection resolution but higher reported rates of uretero‑vesical junction obstruction (UVJO) or late obstruction that can necessitate re‑implantation.

Meta-analyses report pooled odds ratios favoring PPC for resolution but also report higher UVJO in some cohorts.

Patient selection considerations: Appropriate candidates typically have documented VUR by VCUG or retrograde cystography and symptomatic disease (e.g., recurrent febrile UTI or graft pyelonephritis); endoscopic injection is often considered after failure of conservative therapy or when a minimally invasive approach is preferred; open re‑implantation may be preferred for high‑grade VUR or when higher radiologic resolution is required.

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

Covered CPT Codes (if selection criteria met)CPTCovered

52327

Cystourethroscopy (including ureteral catheterization); with subureteric injection of implant material.

Other CPT codes related to the policyCPT

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).

Covered HCPCS CodesHCPCSCovered

L8604	Injectable bulking agent, dextranomer / hyaluronic acid copolymer implant, urinary tract, 1 ml, includes shipping and necessary supplies.
L8606	Injectable bulking agent, synthetic implant, urinary tract, 1 ml syringe, includes shipping and necessary supplies.

HCPCS Codes Not Covered / Related to Experimental AgentsHCPCSNot Covered

Q3031	Collagen skin test.
L8603	Injectable bulking agent, collagen implant, urinary tract, 2.5 ml syringe, includes shipping and necessary supplies.
Q2026	Injection, Radiesse, 0.1 ml.

ICD-10 Diagnosis Codes (covered if selection criteria met)ICD-10Covered

N13.70 - N13.9

Vesicoureteral-reflux

Codes mentionedmixed

No codes listed

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

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

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

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

VUR grading — Reflux graded I–V based on VCUG appearance

Grading scaleVUR is graded I–V by voiding cystourethrography: Grade I = reflux into non-dilated ureter; Grade II = reflux into renal pelvis and calyces without dilation; Grade III = mild–moderate dilation with minimal blunting of fornices; Grade IV = moderate ureteral tortuosity and dilation; Grade V = gross dilation, loss of papillary impressions, and ureteral tortuosity.

Clinical implicationGrades I–III often have high spontaneous resolution rates; surgical intervention is rarely indicated for these lower grades.

Higher-grade managementGrade IV–V reflux more commonly require surgical correction (open ureteral re-implantation or endoscopic subureteral injection).

Bulking agents considered medically necessary — FDA‑approved agents

FDA‑approved examplesDextranomer/hyaluronic acid copolymer (Deflux); polydimethylsiloxane (Macroplastique); polytetrafluoroethylene (Teflon).

Policy Revision History

2023-08-08policy_reviewLatest

Policy last reviewed on 08/08/2023; status recorded as current with next scheduled review on 06/13/2024.

2001-08-21policy_effective

Policy originally became effective on 08/21/2001.

Policy Summary

PayerAetna

PolicyVesicoureteral Reflux Treatment by Endoscopic Injection of Bulking Agents

Policy CodePolicy 0534

Change TypeAnnual review

Effective DateAug 21, 2001

Last ReviewAug 8, 2023

Next Review DateJun 13, 2024

Key ActionDocument preoperative VUR grade, prior conservative therapy failure, and planned bulking agent; obtain postoperative VCUG at ~3 months to confirm radiologic success.

SourceLink

On This Page

Studies of pediatric primary VUR and transplant populations show differing radiologic versus clinical outcomes and should inform patient selection.

Outcomes and follow-up: Follow‑up imaging (e.g., VCUG at ~3 months) and clinical monitoring for recurrent UTIs and renal function are used to assess radiologic and clinical success; obstruction events have been reported and may necessitate stenting or open surgery.

Multiple studies report imaging at ~3 months and longer‑term follow‑up; obstruction after injection has led to re‑implantation in some cases.

Pediatric transplant recipients: lower pooled success and notable obstruction rates — consider prior review

Denial Risk

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

Denial Risk

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

Denial Risk

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

Note

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

Billing Rule

Coding documentation

Include specific CPT and HCPCS codes on claims and authorization requests; link codes to the medical necessity rationale and documentation. Use CPT 52327 for subureteric injection and applicable HCPCS (e.g., L8604, L8606) for injectable bulking agents when covered.

Covered CPT example: 52327 (cystourethroscopy with subureteric injection)
Relevant HCPCS examples: L8604 (Dx/HA), L8606 (synthetic implant)

Documentation Required

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

Documentation Required

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

Note

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

Step Therapy

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

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

ScopeAetna considers endoscopic injection of FDA‑approved bulking agents medically necessary for specified indications when conservative treatments have failed.

Agent selection noteDeflux is absorbable and has lower obstruction risk but may lose effectiveness over time; non‑absorbable agents (e.g., Vantris) may be more durable but carry higher obstruction risk.

STING/HIT/double-HIT — Endoscopic techniques and brief descriptions

STINGSubureteric transurethral injection (STING): injection of bulking agent beneath the ureteral orifice at the 6 o’clock position to change the intravesical ureter angle and correct reflux.

HITHydrodistention implantation technique (HIT): with the ureter distended by irrigation, injection is made within the ureteral orifice beneath the mucosa (intra-orifice/tunnel injection).

Double‑HITDouble‑HIT: two injections — first more proximal within the ureteral tunnel and second more distal beneath the ureteral orifice to augment the submucosal tunnel.

PPC (Vantris) — definition and note re: resolution and obstruction risk

DefinitionPPC (polyacrylate‑polyalcohol copolymer, Vantris) is a non‑biodegradable tissue‑augmenting bulking agent used for endoscopic correction of VUR.

EfficacySeries report high initial resolution rates (e.g., 86.4% after single injection; increasing to >99% with additional injections in one cohort).

Safety notePPC has a measurable late ureteral obstruction risk (reported ~6.2% of RRUs or ~8% of children in cohorts), requiring long‑term follow‑up and potential ureteral re‑implantation.

STING and HIT — restated technique definitions

STING definitionSubureteric transurethral injection: inject bulking agent into detrusor immediately beneath the ureteral orifice at the 6 o’clock position to bolster the orifice.

HIT definitionHydrodistention implantation technique: distend the ureter with irrigation and inject within the ureteral orifice beneath the mucosa (intra‑orifice/tunnel).

Technique selectionChoice between STING and HIT depends on surgeon preference, anatomy, and may influence success rates; double‑HIT is a two‑injection variant used for additional augmentation.

Bulking agents — list of injectable materials and short descriptors

Examples of injectable materialsDextranomer/hyaluronic acid copolymer (Deflux) — absorbable, lower obstruction risk.

Non‑absorbable optionPolyacrylate‑polyalcohol copolymer (PPC, Vantris) — non‑biodegradable, higher initial resolution but increased obstruction risk.

Other agentsPolydimethylsiloxane (Macroplastique) and polytetrafluoroethylene (Teflon) — historically used bulking agents described in the policy.

Experimental/Not endorsedAgents considered experimental/investigational include autologous blood, calcium hydroxyapatite, chondrocytes, Durasphere, fat, glutaraldehyde cross‑linked bovine dermal collagen, myoblasts, polyacrylamide hydrogel (Bulkamid) in some contexts.