Best Practices: Appropriateness Documentation and Coding for Prostate Artery Embolization (PAE)

Purpose

This statement aims to provide clear guidelines for the appropriate use and coding of Prostate Artery Embolization (PAE) to ensure adherence to clinical best practices, accurate billing, and compliance with regulatory standards. Developed by the Outpatient Endovascular Interventional Society (“OEIS”) Economics & Health Policy Committee, this document reflects the commitment to advancing minimally invasive interventional radiology procedures with transparency and accountability.

This document includes official policies and recommendations of the OEIS.  The policy and recommendations herein reflect the current thinking of OEIS and are based on the documents reviewed by the OEIS, all of which are included in the bibliography.  Should additional information become available, the policies and recommendations could be out of date; therefore, this policy will be updated biannually.

This policy notwithstanding, it is the responsibility of physicians to know payer coding, coverage and reimbursement policies and to submit claims that comply with those policies (e.g., that contain, among other things, accurate and correct coding).  It is important to understand that OEIS does not guarantee or warrant that following the policies and recommendations in this document will result in coverage or reimbursement for PAE.  Therefore, it is important for all physicians to consider consulting with lawyers and/or professional coders to maximize the chance of having PAE covered and reimbursed. This document has been developed with consideration of Medicare audits and third-party independent coding reviews to ensure adherence to compliance standards and accuracy in billing practices.

Scope

This document is intended for use by interventional physicians, medical coders, billing teams, and affiliated healthcare professionals. It addresses:

• Clinical indications and appropriateness for PAE.
• Coding standards and compliance.
• Evidence-based practices to support reimbursement claims.
• Collaboration with payors to standardize coding practices.

Guiding Principles

1. Patient-Centered Care: Ensure that PAE is performed employing evidence-based clinical guidelines for the treatment of benign prostatic hyperplasia (BPH) and related conditions.
2. Accuracy in Documentation: Maintain thorough and detailed procedural documentation to benefit the patient’s healthcare and to support coding and billing.
3. Compliance with Regulations: Align coding practices with the guidelines set forth by the American Medical Association (AMA), the Centers for Medicare & Medicaid Services (CMS), and other governing bodies.
4. Education and Advocacy: Promote awareness among clinicians, coders, and payors about the clinical benefits and coding nuances of PAE.

Policy Framework

1. Clinical Indications for PAE

Prostate Artery Embolization (PAE) is a minimally invasive procedure increasingly supported by robust clinical evidence as a viable treatment for benign prostatic hyperplasia (BPH). Over the past decade, numerous randomized controlled trials (RCTs) and meta-analyses have demonstrated its efficacy, safety, and cost-effectiveness compared to traditional surgical options such as transurethral resection of the prostate (TURP).

Background and History

Historically, BPH has been treated surgically through procedures like TURP and simple prostatectomy, which, while effective, are associated with significant morbidity

[1]^,[2],[3],[4].These include risks of ejaculatory dysfunction, erectile dysfunction, urethral strictures, and urinary incontinence. To mitigate these complications, minimally invasive treatments such as PAE have emerged as alternatives.

The United Kingdom’s National Institute for Health and Care Excellence (NICE) endorsed PAE in 2018 for BPH treatment based on clinical outcomes and safety[5]. The Society of Interventional Radiology and an international multi-society panel reviewed available data in 2019, concluding that PAE is supported by Level 1 evidence and should be offered as a treatment option for BPH-related lower urinary tract symptoms (LUTS)[6]. In 2023, the American Urological Association (AUA) updated its guidelines to include Prostate Artery Embolization (PAE) as a treatment option that should be offered to patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) [7]. This inclusion reflects the growing body of evidence supporting PAE’s efficacy and safety.

The AUA’s endorsement signifies a significant shift in the management of BPH, offering patients a minimally invasive alternative to traditional surgical procedures. Healthcare providers should consider PAE as a viable option, particularly for patients seeking less invasive treatments with favorable outcomes.

 

Data Supporting PAE

As stated previously, the American Urological Association (AUA) updated its guidelines regarding treatment option for patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) in 2023, to include Prostate Artery Embolization (PAE). This inclusion reflects the growing body of evidence supporting PAE’s efficacy and safety.

Randomized Controlled Trials (RCTs): To date, six RCTs[8]^{,[9],[10],[11],[12],[13],[14]} comparing PAE to TURP with follow-up periods of up to two years have consistently demonstrated substantial clinical improvement. These studies reported improvements in International Prostate Symptom Score (IPSS) by 10-16 points, with comparable enhancements in quality of life (QOL) and urinary flow metrics. Notably, PAE preserved erectile function, a key consideration for many patients.

• Meta-Analyses: A meta-analysis of over 1200 patients revealed that PAE provides durable symptomatic relief with a mean IPSS improvement of 16.2 points at one year and sustained benefits over three years. The procedure also reduced prostate volume by 26% on average and maintained significant improvements in post-void residual (PVR) and QOL scores[15].
• Cost Analysis: Compared to TURP, PAE is significantly more cost-effective[16]^{,[17],[18],[19]} often performed on an outpatient basis, and associated with fewer hospital stays and resource utilization.

Indications for PAE

PAE may be considered appropriate when the following criteria are met:

1. Pre-Procedural Evaluation:

• Comprehensive clinical assessment, including International Prostate Symptom Score (IPSS) and relevant urological testing.

1. Patient Profile:

• Moderate to severe LUTS refractory to or intolerant of medical management, or
• Prostate gland size ≥50 grams, or
• Poor surgical candidacy due to advanced age, comorbidities, or anticoagulation therapy.
  1. Specific Conditions:
     1. Acute or chronic urinary retention requiring catheterization, or
     2. Hematuria of prostatic origin unresponsive to standard therapies, or
     3. Patients desiring to preserve erectile and/or ejaculatory function.

Safety and Complications

Technical success rates for PAE approach 100% in experienced centers. Major complications are exceedingly rare, with a reported incidence of less than 0.5%. PAE avoids transurethral access, mitigating risks like urethral stricture and urinary incontinence commonly associated with TURP.

Exclusions

PAE is not recommended as a primary treatment in cases of:

• Bladder dysfunction or neurogenic bladder.
• High-grade prostate cancer.
• Prolonged catheter dependence (>12 months).

2. Coding Guidelines for Prostate Artery Embolization (PAE)

The general principle used during embolization coding is that “only one embolization code should be reported for each surgical field (ie, the area immediately surrounding and directly involved in a treatment/ procedure). Embolization procedures performed at a single setting and including multiple surgical fields (eg, a patient with multiple trauma and bleeding from the pelvis and the spleen) may be reported with multiple embolization codes with the appropriate modifier2¹ (eg, Modifier 59)”.  Coding for PAE is governed by this same principle of treating a “surgical field.” In the case of prostate artery embolization, the target organ is the prostate. As such the code for solid organ infarction, 37243 [vascular embolization or occlusion, inclusive of all radiologic supervision and interpretation, intraprocedural road. mapping, and imaging guidance necessary to complete the intervention; for tumors, organ ischemia or infarction], is the appropriate embolization code to be used. In cases where there are significant arterial shunts or high risk of refluxing into branches supplying structures such as the penis, rectum or bladder, proximal coil embolization may be necessary to prevent particle embolization into these structures. Based on the coding instructions included in the AMA CPT 2023 manual (as quoted above), in these instances it would be appropriate to also code 37242 [vascular embolization or occlusion, inclusive of all radiologic supervision and interpretation, intraprocedural road. mapping, and imaging guidance necessary to complete the intervention; arterial, other than hemorrhage or tumor (eg, congenital or acquired arterial malformations, arterial venous malformations, arteriovenous fistulas, aneurysms, pseudoaneurysm)] as these structures are not part of the target operative field and are not directly involved in the intended treatment.

Overview of Relevant CPT Codes

• 37243 Vascular embolization; for tumors, organ ischemia, or infarction: Utilized for embolization procedures targeting tumors or organs, including the prostate for benign prostatic hyperplasia (BPH). Medicare’s National Coverage Determination (NCD) generally supports the use of this code for PAE when clinically appropriate (Manual Section Number 20.28 Publication Number 100-3 Manual Section Number 20.28 Manual Section Title: Therapeutic Embolization, Version Number 1. Effective Date of this Version12/15/1978cms.gov)[20].
  Note: While 37243 is generally recommended, physicians performing the procedure should familiarize themselves with commercial carrier policies that may reference other embolization codes, such as 37242, for use in specific scenarios.
• 37242 vascular embolization; arterial, other than hemorrhage or tumor: Applied for embolization procedures not specifically tumor-related, such as treating collateral vessels or other conditions identified during angiography. It should be utilized in PAE when it is deemed medically necessary to embolize shunts, collateral vessels or adjacent arterial branches to reasonably avoid non-target particle embolization into adjacent structures. Its use and MUE (medically unlikely edit) applicability may vary based on commercial carrier policies.
• Within the introductory language in the CPT code book, “embolization codes include all associated radiological supervision and interpretation, intraprocedural guidance and road mapping, and imaging necessary to document completion of the procedure. They do not include diagnostic angiography and all necessary catheter placements. Codes for catheter placement may be separately reported using selective catheter placement codes if used consistent with guidelines.” [21] As such, the following selective catheter placement codes may be used in addition to the embolization codes reported.
• 36247 (selective catheter placement, arterial system; Initial 3rd order or more selective abdominal, pelvic, or lower extremity artery branch, within a vascular family): Represents catheter placement in a third order vessel. For less selective catheter placements (first or second order) use 36245 and/or 36246.
• 36248 (selective catheter placement, arterial system; Additional 2nd order, 3rd order, and beyond, abdominal, pelvic, or lower extremity branch, within a vascular family (list in addition to code for initial second or third order vessel as appropriate): Represents catheter placement in additional 2^nd and third order branches of a vascular family, as required for accessing specific vascular anatomy.

Documentation Requirements for Coding Accuracy

1. Pre-Procedural Requirements

• Clinical Justification:
  • Document patient history and symptoms, including International Prostate Symptom Score (IPSS) assessment.
  • Include urological testing and imaging studies (e.g., CT angiography, MRI) that demonstrate eligibility for PAE.
• Imaging and Planning:
  • Provide detailed pre-procedural imaging findings that support the vascular approach and the necessity of embolization.

1. Procedural Notes

• Procedure Description:
  • Outline catheter placement, vessels accessed, and embolization performed.
  • Identify embolization agents used, such as microspheres, and their specific application.
• Use of CPT 37242:
  • Explain collateral embolization, if performed, including rationale (e.g., rectal collateral management).
  • Document the separate arterial supply treated and its impact on clinical outcomes.
• Use of CPT 37243:
  • Clearly identify the target organ (e.g., prostate) treated and summarize the embolization process.
• Compliance with NCCI Edits:
  • Ensure detailed procedural notes differentiate distinct embolization procedures.
  • Avoid unsupported dual reporting of 37242 and 37243 unless justified by distinct anatomical targets or surgical fields.

1. Post-Procedural Documentation

• Immediate Outcomes:
  • Record patient status, any complications, and the immediate efficacy of the procedure.
• Follow-Up:
  • Document scheduled imaging or clinical assessments to confirm long-term success and absence of complications.

Dual Code Reporting

According to the CMS “Proper Use of Modifiers” guidance document (MLN1783722)[22], dual reporting of embolization codes such as 37242 and 37243 is permissible under the following conditions:

• “Separate Territories: A “separate territory” is defined as involving:
  • Different organs.
  • Different anatomic regions.
  • In limited situations, different non-contiguous lesions in different anatomic regions of the same organ”

For example, if embolization of the prostatic artery is performed for BPH (37243), and collateral embolization is required to protect the rectum or bladder (37242), these can be reported as separate procedures. Such cases must document:

• Distinct arterial supplies for each targeted organ or region.
• Medical necessity for each embolization performed.
• Justification for the use of modifier XS to indicate a separate structure.

Including these details ensures compliance with NCCI edits and minimizes the risk of claim denial.

Call to Action

The OEIS Economics & Health Policy Committee encourages interventional practices to adopt this policy as a framework for ensuring consistency and compliance in PAE procedures and coding. Stakeholders are invited to provide feedback and collaborate in refining these guidelines to better serve patients and healthcare providers.

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[4] Serretta V, Morgia G, Fondacaro L, et al. Open prostatectomy for benign prostatic enlargement in southern Europe in the late 1990s: a contemporary series of 1800 interventions. Urology 2002; 60:623–627

 

[5] National Institute for Health and Care Excellence. Prostate artery embolization for lower urinary tract symptoms caused by benign prostatic hyperplasia. IPG611. Published 25 April 2018

 

[6] McWilliams JP, Bilhim, TA, Carnevale, FC, et al. Society of interventional radiology multisociety consensus position statement on prostatic artery embolization for treatment of lower urinary tract symptoms attributed to benign prostatic hyperplasia: from the society of interventional radiology, the cardiovascular and interventional radiological society of Europe, societe Francaise de radiologie, and the British society of interventional radiology. J Vasc Interv Radiol 2019; 30:627-637

 

[7] American Urological Association. (Published 2021; Amended 2023). Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA Guideline. www.auanet.org.

 

[8] Abt D, Hechelhammer L, Müllhaupt G, Markart S, Güsewell S, Kessler TM, Schmid HP, Engeler DS, Mordasini L. Comparison of prostatic artery embolisation (PAE) versus transurethral resection of the prostate (TURP) for benign prostatic hyperplasia: randomised, open label, non- inferiority trial. BMJ. 2018 Jun 19;361:k2338. doi: 10.1136/bmj.k2338. PMID: 29921613; PMCID: PMC6006990

 

[9] Gao YA, Huang Y, Zhang R, et al. Benign prostatic hyperplasia: prostatic arterial embolization versus transurethral resection of the prostate–a prospective, randomized, and controlled clinical trial. Radiology 2014; 270: 920–928

 

[10] Carnevale FC, Iscaife A, Yoshinaga EM, et al. Transurethral resection of the prostate (TURP) versus original and PErFecTED prostate artery embolization (PAE) due to benign prostatic hyperplasia (BPH): preliminary results of a single center, prospective, urodynamic-controlled analysis. Cardiovasc Intervent Radiol 2016; 39:44–52

 

[11] Bilhim T, Pisco J, Campos Pinheiro L, Rio Tinto H, Fernandes L, Pereira JA, Duarte M, Oliveira AG. Does polyvinyl alcohol particle size change the outcome of prostatic arterial embolization for benign prostatic hyperplasia? Results from a single center randomized prospective study. J Vasc Interv Radiol. 2013 Nov;24(11):1595-602.e1. doi: 10.1016/j.jvir.2013.06.003. Epub 2013 Aug 3. PMID: 23916874.

 

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[13] Radwan A, Farouk A, Higazy A, Samir YR, Tawfeek AM, Gamal MA. Prostatic artery embolization versus transurethral resection of the prostate in management of benign prostatic hyperplasia. Prostate Int. 2020 Sep;8(3):130- 133. doi: 10.1016/j.prnil.2020.04.001. Epub 2020 Apr 23. PMID: 3310239

 

[14] Abt D, Müllhaupt G, Hechelhammer L, Markart S, Güsewell S, Schmid HP, Mordasini L, Engeler DS. Prostatic Artery Embolisation Versus Transurethral Resection of the Prostate for Benign Prostatic Hyperplasia: 2-yr Outcomes of a Randomised, Open-label, Single- centre Trial. Eur Urol. 2021 Jul;80(1):34-42. doi: 10.1016/j.eururo.2021.02.008. Epub 2021 Feb 19. PMID: 33612376.

 

[15] Malling B, Roder MA, Brasso K, et al. Prostate artery embolisation for benign prostatic hyperplasia: a systematic review and meta-analysis. Eur Radiol 2019; 29:287–298

 

[16] Bagla S, Smirniotopoulos J, Orlando J, Piechowiak R. Cost analysis of prostate artery embolization (PAE) and transurethral resection of the prostate (TURP) in the treatment of benign prostatic hyperplasia. Cardiovasc Intervent Radiol 2017; 40:1694–1697.

 

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[19] Xiao Wu, Alice Zhou, Michael Heller, Thomas Chi, and Ryan Kohlbrenner. Comparison of Minimally Invasive Procedures for Benign Prostatic Hyperplasia: A Cost-effectiveness Analysis. Radiology 2023 309:3

 

[20] Centers for Medicare & Medicaid Services (CMS) Internet-Only Manual (IOM) Publication 100-04, Medicare Claims Processing Manual, Chapter 23, Section 20.9, and Chapter 12, Section 30 https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=52&ncdver=1&bc=0

 

[21] Synovec MS, et al  CPT 2023 Professional Edition   American Medical Association  pg 317-319

[22] CMS Modifier Guidelines Document MLN1783722 – “Proper Use of Modifiers: 59, XE, XP, XS, XU” https://www.cms.gov/files/document/mln1783722-proper-use-modifiers-59-xe-xp-xs-and-xu.pdf