Permanently Implanted Prostatic Devices for Benign Prostatic Hyperplasia
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This policy governs coverage for permanently implanted prostatic stent devices (e.g., ProVee System, Zenflow Spring Implant) used to treat lower urinary tract symptoms from benign prostatic hyperplasia for members of Blue Cross and Blue Shield of Louisiana.
No material clinical or coverage changes in this revision.
Coverage Criteria
Investigational / Not Covered
Covered when ALL of the following are met
Services determined to be investigational are not covered per policy.
Policy cites FDA approval but emphasizes need for long-term safety data.
These evidentiary limitations underpin the investigational determination.
Insufficient evidence / Not established as improving net health outcome
Coverage stance based on evidence summary
FDA approvals were granted with required 60-month postapproval studies; systematic review of legacy stents showed high rates of encrustation, failure requiring removal or repositioning, and urinary tract infection; no trials directly compare these devices to active surgical alternatives.
The Company considers the use of permanently implanted prostatic stent devices (for example, the ProVee System or the Zenflow Spring Implant) for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia to be investigational. Coverage is not available for investigational medical treatments, devices, or procedures.
Available evidence does not include direct comparisons of permanently implanted prostatic stent devices with active treatments such as transurethral resection of the prostate or prostatic urethral lift; no studies have directly compared these implanted stents to standard procedural alternatives.
Because these permanently implanted prostatic stent devices are designated investigational under this policy, their use is considered not medically necessary for purposes of coverage determinations.
The investigational designation reflects insufficient evidence of net health benefit and safety concerns. The evidence summary notes historically high complication rates with legacy permanent stents (including encrustation, device failure requiring removal or repositioning, and urinary tract infection) and that FDA approvals for recently reviewed devices require 60-month postapproval studies. Given these unresolved effectiveness and safety issues, permanently implanted prostatic stents are considered investigational.
Coding and Device Parameters
| P250011 | PMA identifier for ProVee System (product code MER) |
| P250007 | PMA identifier for Zenflow Spring Implant (product code MER) |
| MER | FDA product code for permanent prostatic implant |
| N40.1 |
| N40.1 |
Provider Actions and Authorization
Prior authorization expectation — investigational services not covered
Services determined to be investigational are not covered under the Company's benefits. Providers should obtain prior authorization when required by the member's product contract to verify coverage determinations before scheduling or performing these services.
- Investigational or experimental services are excluded from coverage.
- Obtain prior authorization when required by product contracts to confirm coverage.
Prior authorization and investigational review — applies to listed CPT/HCPCS/ICD-10 codes
Prior authorization considerations apply to the services and codes identified in this policy; investigational interventions may require review and can be denied if determined investigational.
Medical therapy before procedural options — expectation of prior medical therapy trial
Patients are generally expected to have tried and had insufficient response to, or intolerable side effects from, appropriate medical therapies before procedural options are considered.
- Medical therapies include α-adrenergic blockers, 5α-reductase inhibitors, combination therapy, antimuscarinics, PDE5 inhibitors, and beta-3 agonists.
- Refer patients for surgical or ablative therapies only if medical therapy is inadequate or not tolerated.
Device labeling parameters — note device-specific indications
Device-specific labeling specifies required anatomic parameters for use: ProVee requires prostatic urethral length ≥3.75 cm and prostate volume 30–80 cc; Zenflow requires prostatic urethral length 25–45 mm and prostate volume 25–80 cc.
- ProVee System (PMA P250011): urethral length ≥3.75 cm; prostate volume 30–80 cc.
- Zenflow Spring Implant (PMA P250007): urethral length 25–45 mm; prostate volume 25–80 cc.
Transition authorization documentation — documentation requirement if prior authorization exists from previous plan
If an authorization for an ongoing course of treatment was provided by a previous health plan, documentation of that prior authorization must be submitted for potential 90-day transition acceptance by Louisiana Blue.
- Provide the previous plan's authorization documentation to Louisiana Blue for the same service and in-network benefit.
- This transition provision does not apply to medications covered under the pharmacy benefit.
Investigational devices denied — claims for investigational devices will be denied
Claims for services determined to be investigational—specifically use of permanently implanted prostatic stent devices for BPH—will be denied because coverage is not available for investigational treatments.
- Use of permanently implanted prostatic stent devices (e.g., ProVee System, Zenflow Spring Implant) for LUTS due to BPH is considered investigational and excluded from coverage.
Investigational designation may trigger denial — investigational status can lead to denial
Treatments or devices designated investigational may be denied based on insufficient evidence of effectiveness or safety per the policy's investigational criteria.
- Interventions judged investigational due to insufficient evidence (including legacy stents with high complication rates) are considered not established and can be denied.
- FDA PMA approvals exist for two devices, but the policy cites insufficient evidence of net health benefit and required postapproval studies.
Background
Benign prostatic hyperplasia (BPH) is a common condition in men that can cause lower urinary tract symptoms (LUTS) such as urinary frequency, urgency, weak stream, nocturia, and incomplete emptying. Symptoms may progress to urinary retention, urinary tract infection, or renal compromise. Symptom severity is commonly assessed with AUASI/IPSS scores, and treatment selection considers symptom bother, prior response to medical therapy, and the risk profile of available procedural options.
Definitions
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