U.S. Anal Fistula Repair Procedures: Epidemiology, Utilization & Reimbursement Trends, 2021 - 2025

Table of Contents

Chapter 1 Methodology & Scope
                   1.1 Segmentation Definition
                   1.2 List of Secondary Sources
                   1.3 List of Abbreviations
                   1.4 Key Report Note
                   1.5 Gvr Internal Database: U.S. Healthcare Facility Mapping & Intelligence Platform
Chapter 2 U.S. Anorectal Fistula - Disease & Patient Landscape
                   2.1 Estimated U.S. Anorectal Fistula Prevalence and Incidence, 2021 - 2025
                       2.1.1 Data Sourced for Estimation
                       2.1.2 Assumptions and Considerations
                       2.1.3 Calculation Framework
                       2.1.4 Sources Considered
                       2.1.5 Validation Factors and Rationale
                   2.2 Crohn's Disease-Associated Fistula Vs. Cryptoglandular (Non-Crohn's) Patient Split, 2025 (%)
                       2.2.1 Data Sourced for Estimation
                       2.2.2 Assumptions and Considerations
                       2.2.3 Calculation Framework
                   2.3 Patient Demographics, 2025
                       2.3.1 Age Group
                           2.3.1.1 Data Sourced for Estimation
                           2.3.1.2 Assumptions and Considerations
                           2.3.1.3 Calculation Framework
                       2.3.2 Sex
                           2.3.2.1 Data Sourced for Estimation
                           2.3.2.2 Assumptions and Considerations
                           2.3.2.3 Calculation Framework
                       2.3.3 Comorbidity Burden (Charlson Comorbidity Index)
                           2.3.3.1 Data Sourced for Estimation
                           2.3.3.2 Assumptions and Considerations
                           2.3.3.3 Calculation Framework
                   2.4 Time From Diagnosis to First Procedure (Patient Journey Analysis)
                       2.4.1 Estimation Logic
                   2.5 Fistula Complexity Classification: Simple Vs. Complex (Inter, Trans, Supra-Sphincteric)
                       2.5.1 Simple Anal Fistulas:
                       2.5.2 Complex Anal Fistula
                       2.5.3 Case Study Published In March 2023: Review of Surgical Techniques for Optimal Outcomes In Simple and Complex Anal Fistula Treatment
                       2.5.4 Role of Mri and Imaging In Complexity Classification
                       2.5.5 Recent Developments and Technology Trends
                           2.5.5.1 Growing Adoption of Sphincter-Sparing Procedures
                               2.5.5.1.1 First U.S. Procedure Using Biohealx Device for Complex Anal Fistulas
                           2.5.5.2 Rising Use of Staged Repair Approaches
                           2.5.5.3 Increasing Patient Awareness and Online Communities
                               2.5.5.3.1 Updated U.S. Clinical Guidelines Increasing Awareness of Anorectal Fistula Management
                       2.5.6 Strategic Importance for the Market
                       2.5.7 Data Sourced for Estimation
                       2.5.8 Assumptions and Considerations
                       2.5.9 Calculation Framework
                   2.6 Prior Non-Surgical Management (Seton Placement, Antibiotics, Anti-Tnf Biologics) Before CPT Procedure
                   2.7 Hospitalizations Attributed to Anorectal Fistula (Primary and Secondary Diagnosis)
                       2.7.1 Case Study: Hospitalizations Attributed to Anorectal Fistula In Patients With Fistulizing Crohn’s Disease In U.S.
                       2.7.2 Role of Emergency Admissions
                           2.7.2.1 Case Study Published In April 2024: Evaluation of Surgical Treatment Outcomes for Anal Fistula Management
                   2.8 Readmission Rates Within 30 Days, 90 Days Post-Procedure, 2025
                       2.8.1 Estimation Sssumptions and Logic
                       2.8.2 Primary Market Intelligence
                       2.8.3 Estimation Framework
Chapter 3 CPT Volume Analysis - total Procedure Counts
                   3.1 total Annual Procedure Volume Across CPT Codes (Combined and Individual), 2021 - 2025
                       3.1.1 Data Sourced for Estimation
                       3.1.2 Assumptions and Considerations
                       3.1.3 Calculation Framework
                   3.2 Year-Over-Year Volume Change (Absolute and %), 2021 - 2025
                       3.2.1 Estimation Logic
                       3.2.2 Calculation Framework
                   3.3 Volume by Procedure Category
                       3.3.1 Data Sourced for Estimation
                       3.3.2 Assumptions and Considerations
                       3.3.3 Estimation Framework
                   3.4 Share of Surgical (46280+46275+46288) Vs. Biologic/Minimally Invasive (46707+46706) Procedures - Trend Over Study Period
                       3.4.1 Calculation Framework
                   3.5 CAGR Analysis Across Study Period by CPT Code (2026 - 2030)
                       3.5.1 Historical Volume Trend Analysis
                       3.5.2 CPT-Level Procedure Maturity
                       3.5.3 Clinical Complexity and Procedure-Mix Shift
                       3.5.4 Site-of-Service and Access Factors
                       3.5.5 Healthcare Access and Reimbursement Factors
                   3.6 Procedure Volume by Patient Age Group (<18, 18-44, 45-64, 65+), 2021 - 2025
                   3.7 Procedure Volume by Patient Sex, 2021 - 2025
                   3.8 Crohn's-Associated Vs. Non-Crohn’s Procedure Volume Per CPT Code, 2021 - 2025
                       3.8.1 Data Inputs Used
                       3.8.2 CPT-Level Attribution Logic
                       3.8.3 Calculation Framework
Chapter 4 Geographic Distribution of Procedures, 2021 - 2025
                   4.1 U.S. National-Level Procedure Volume, 2021 - 2025
                   4.2 top 10 States by total Fistula Repair Volume, 2021 - 2025
                       4.2.1 Calculation Framework
                   4.3 U.S. Census Regional Analysis: Northeast, Midwest, South, and West, 2021 - 2025
                       4.3.1 Calculation Framework
                   4.4 Metro Area / Cbsa-Level top Markets, 2021 - 2025
                       4.4.1 Methodology Approach
                       4.4.2 Alocation Logic by Metro Area
                       4.4.3 Estimation Framework
                   4.5 State-Level Crohn’s Vs. Non-Crohn’s Procedure Distribution, 2021 - 2025
                       4.5.1 Data Sourced for Estimation
                       4.5.2 Assumptions and Considerations
                       4.5.3 Calculation Framework
                   4.6 Heat Map-Style Data Output for Procedures Per 100,000 Population
Chapter 5 Geographic Distribution of Procedures, 2021 - 2025
                   5.1 Site of Service Analysis, 2021 - 2025
                   5.2 Site of Service Split by CPT Code, 2021 - 2025
                       5.2.1 46280
                       5.2.2 46275
                       5.2.3 46288
                       5.2.4 46707
                       5.2.5 46706
                           5.2.5.1 Estimation Assumptions and Logic
                           5.2.5.2 Estimation Framework
                   5.3 Site of Service Split by Payer Type: Commercial Vs. Medicare, 2021 - 2025
                       5.3.1 Asc
                       5.3.2 Hopd
                       5.3.3 Non-Facility (Private office)
                       5.3.4 Inpatient
                           5.3.4.1 Estimation Assumptions and Logic
                           5.3.4.2 Estimation Framework
                   5.4 Site of Service Distribution by Geography, 2021 - 2025
                       5.4.1 Asc
                       5.4.2 Hopd
                       5.4.3 Non-Facility (Private office)
                       5.4.4 Inpatient
                       5.4.5 Regional Allocation Approach
                       5.4.6 Computation Method
                   5.5 Site of Service Distribution by Crohn’s Vs. Non-Crohn’s Diagnosis, 2021 - 2025
                       5.5.1 Asc
                       5.5.2 Hopd
                       5.5.3 Non-Facility (Private office)
                       5.5.4 Inpatient
                           5.5.4.1 Allocation Approach
                           5.5.4.2 Calculation Framework
                   5.6 Inpatient Vs. Outpatient Volume Trend by CPT Code, 2021 - 2025
                       5.6.1 46280
                       5.6.2 46275
                       5.6.3 46288
                       5.6.4 46707
                       5.6.5 46706
                       5.6.6 Calculation Approach
Chapter 6 Allowed Amounts & Reimbursement Analysis, 2025
                   6.1 Average Allowed Amount Per CPT Code At National Level, 2025
                       6.1.1 Data Sourced for Estimation
                       6.1.2 Assumptions and Considerations
                       6.1.3 Calculation Framework
                       6.1.4 Sources Considered
                       6.1.5 Validation Factors and Rationale
                   6.2 Allowed Amounts by Payer Type
                       6.2.1 Data Sourced for Estimation
                       6.2.2 Calculation Framework
                       6.2.3 Assumptions and Considerations
                   6.3 Allowed Amounts by Site of Service: Asc Vs. Hopd Vs. Inpatient
                       6.3.1 Data Sourced for Estimation
                       6.3.2 Assumptions and Considerations
                       6.3.3 Calculation Framework
                       6.3.4 Validation Rationale
                   6.4 State-Level Allowed Amount Variation, Including top 10 Highest and Lowest Reimbursement States
                       6.4.1 Data Sourced for Estimation
                       6.4.2 Assumptions and Considerations
                       6.4.3 Calculation Framework
                       6.4.4 Validation Rationale
                   6.5 Year-Over-Year Allowed Amount Trend
                       6.5.1 Data Sourced for Estimation
                       6.5.2 Assumptions and Considerations
                       6.5.3 Calculation Framework
                       6.5.4 Validation Rationale
                   6.6 Allowed Amount for Crohn’s Vs. Non-Crohn’s Fistula Procedures, 2025
                       6.6.1 Data Sourced for Estimation
                       6.6.2 Assumptions and Considerations
                       6.6.3 Calculation Framework
                       6.6.4 Validation Rationale
                   6.7 total U.S. Spends Estimate: Volume × Allowed Amount by CPT Code, 2025
                       6.7.1 Data Sourced for Estimation
                       6.7.2 Assumptions and Considerations
                       6.7.3 Calculation Framework
                       6.7.4 Validation Rationale
Chapter 7 Payer Mix Analysis - Commercial Vs. Medicare / TPE, 2025
                   7.1 total Procedure Volume by Payer Type: Commercial, Medicare Ffs, Medicare Advantage / TPT, Medicaid, Self-Pay / Other, 2025
                       7.1.1 Data Sources for Estimation
                       7.1.2 Assumptions and Considerations
                       7.1.3 Calculation Framework
                       7.1.4 Validation Factors and Rationale
                   7.2 Payer Mix Percentage Split by CPT Code
                       7.2.1 Data Sources for Estimation
                       7.2.2 Assumptions and Considerations
                       7.2.3 Calculation Framework
                       7.2.4 Qfd / Factor Model
                       7.2.5 Validation Factors and Rationale
                   7.3 Payer Mix Split by Site of Service, 2025
                       7.3.1 Data Sources for Estimation
                       7.3.2 Assumptions and Considerations
                       7.3.3 Calculation Framework
                       7.3.4 Qfd / Factor Model
                       7.3.5 Validation Factors and Rationale
                   7.4 Payer Mix by Geography, Including top States, 2025
                       7.4.1 Data Sources for Estimation
                       7.4.2 Assumptions and Considerations
                       7.4.3 Calculation Framework
                       7.4.4 Validation Factors and Rationale
                       7.5 Commercial Vs. Medicare Comparison, 2025
                   7.6 Medicare Advantage / Tpt Share Within Medicare-Covered Procedure, 2025
                       7.6.1 Data Sources for Estimation
                       7.6.2 Assumptions and Considerations
                       7.6.3 Calculation Framework
                       7.6.4 Qfd / Factor Model
                       7.6.5 Validation Factors and Rationale
                   7.7 Payer Mix for Crohn’s-Associated Vs. Non-Crohn’s Procedures, 2025
                       7.7.1 Data Sources for Estimation
                       7.7.2 Assumptions and Considerations
                       7.7.3 Calculation Framework
                       7.7.4 Validation Factors and Rationale
                       7.7.5 Medicare, Medicaid, Coding, and Reimbursement Landscape for Anal Fistula Removal Procedures
                           7.7.5.1 Reimbursement Landscape for Traditional Anal Fistula Repair Procedures
                           7.7.5.2 Reimbursement Landscape for Biologic and Advanced Anal Fistula Repair Technologies
                           7.7.5.3 Key CPT Codes Used for Anal Fistula Procedures
                           7.7.5.4 Medicare Reimbursement Rrends
Chapter 8 ICD-10 Diagnosis Code Segmentation - Crohn’s Vs. Non-Crohn’s, 2025
                   8.1 ICD-10 Diagnosis Codes Associated With Selected CPT Codes
                   8.2 Crohn’s-Related Anal Fistula Diagnosis Mapping
                   8.3 Non-Crohn’s / Perianal Fistula Diagnosis Mapping
                   8.4 Crohn’s Vs. Non-Crohn’s Split by CPT Code, 2025
                       8.4.1 Data Sources for Estimation
                       8.4.2 Assumptions and Considerations
                   8.5 Crohn’s Vs. Non-Crohn’s Split by Site of Service, 2025
                       8.5.1 Data Sources for Estimation
                       8.5.2 Assumptions and Considerations
                       8.5.3 Example Calculation
                       8.5.4 Validation Factors and Rationale
                       8.5.5 Validation Factors and Rationale
                   8.6 Crohn’s Vs. Non-Crohn’s Split by Payer Type, 2025
                       8.6.1 Data Sources for Estimation
                       8.6.2 Assumptions and Considerations
                       8.6.3 Directional Share Breakdown Framework
                       8.6.4 Example Calculation
                       8.6.5 Validation Factors and Rationale
                   8.7 Crohn’s Vs. Non-Crohn’s Split by Geography, 2025
                       8.7.1 Data Sources for Estimation
                       8.7.2 Assumptions and Considerations
                       8.7.3 Example Calculation
                       8.7.4 Validation Factors and Rationale
Chapter 9 Repeat Procedures & Treating Specialty Analysis, 2025
                   9.1 Percentage of Patients Undergoing Repeat Fistula Repair Procedure Within 12 & 24 Months, 2025 (Ball Park Range)
                       9.1.1 Data Sources for Estimation
                       9.1.2 Assumptions and Considerations
                       9.1.3 Calculation Framework
                       9.1.4 Final Estimates
                       9.1.5 Validation Factors and Rationale
                   9.2 Repeat Procedure Rates by CPT Code, 2025 (Ball Park Range)
                       9.2.1 Data Sources for Estimation
                       9.2.2 Repeat Risk Logic by CPT
                       9.2.3 Calculation Framework
                       9.2.4 Validation Factors and Rationale
                   9.3 Repeat Procedure Rates by Crohn’s Vs. Non-Crohn’s Diagnosis, 2025 (Ball Park Range)
                       9.3.1 Data Sources for Estimation
                       9.3.2 Assumptions and Considerations
                       9.3.3 Calculation Framework
                       9.3.4 Validation Factors and Rationale
                   9.4 Repeat Procedure Rates by Site of Service and Payer Type, 2025 (Ball Park Range)
                       9.4.1 Data Sources for Estimation
                       9.4.2 Site-Based Repeat Logic
                       9.4.3 Payer-Based Repeat Logic
                       9.4.4 Calculation Framework
                       9.4.5 Validation Factors and Rationale
                   9.5 Treating Specialties: Colorectal Surgery, General Surgery, Gastroenterology, Proctology, and Other Specialties, 2025
                       9.5.1 Colorectal Surgery
                           9.5.1.1 Case Study: Northwell’s Staten Island University Hospital Performs First U.S. Procedures In August 2025 Using Fda-Approved Biohealx Anal Fistula Device
                       9.5.2 General Surgery
                       9.5.3 Gastroenterology
                           9.5.3.1 Case Study: American Gastroenterological Association (Aga) Highlights Clinical Challenges In Managing Ulcerative Colitis Patients With Anal Fistulas
                       9.5.4 Proctology
                       9.5.5 Other Specialties
                           9.5.5.1 Case Study: Penn State Health Launches Stem Cell Trial for Perianal Fistula Treatment In Crohn’s Disease Patients
                   9.6 Specialty Share by CPT Code, Site of Service, Payer Type, and Geography, 2025 (Ball Park Range)
                       9.6.1 Data Sources for Estimation
                       9.6.2 Assumptions and Considerations
                       9.6.3 Calculation Framework
                       9.6.4 Validation Rationale
                   9.7 Average Number of Fistula Repair Procedures Per Patient Over 12-Month and 24-Month Follow-Up Periods, 2025
                       9.7.1 Data Sources for Estimation
                       9.7.2 Assumptions and Considerations
                       9.7.3 Calculation Framework
                   9.8 Average Time Between Repeat Procedures (Where Multiple Repeat Procedures are Observed)
                       9.8.1 Data Sources for Estimation
                       9.8.2 Assumptions and Considerations
                       9.8.3 Calculation Framework
                       9.8.4 Final Output Validation
                   9.9 Longitudinal Patient Episode Cost Analysis, 2025
                       9.9.1 Directional total Cost Per Patient Episode Over 12 Months and 24 Months, 2025
                       9.9.2 Data Sources for Estimation
                       9.9.3 Assumptions and Considerations
                       9.9.4 Calculation Framework
                       9.9.5 Scenario Analysis for Low / Base / High Episode Cost Based on Repeat Procedure Frequency
                       9.9.5.1 Scenario Structure
Chapter 10 Potential Partner Company Landscape
                   10.1 Identification of Companies Likely to be Interested In Partnering
                   10.2 Medical Device Companies with Fistula Repair, Colorectal Surgery, Biologic Implant, Sealant, or Wound Closure Relevance
                   10.3 Company Profiles
                       10.3.1 Product Benchmarking
                           10.3.1.1 Cook
                           10.3.1.2 Baxter International
                           10.3.1.3 Ethicon
                           10.3.1.4 Medtronic
                           10.3.1.5 Olympus Corporation
                           10.3.1.6 Integra Lifesciences Corporation
                           10.3.1.7 Tela Bio, Inc.
                           10.3.1.8 Mimedx
                           10.3.1.9 Takeda Pharmaceutical Company Limited
                           10.3.1.10 Organogenesis
                           10.3.2 Pipeline Products
                   10.4 Partner Prioritization Matrix
                   10.5 Recent Relevant Partnerships, Licensing, and M&A Activity
                       10.5.1 Partnerships
                       10.5.2 Megers & Acquisitions
                       10.5.3 Licensing