American Society of Hirudotherapy

Clinical Practice

Practical guidance for implementing hirudotherapy in clinical settings

Last Updated: March 1, 2026Reviewed by: Andrei Dokukin, MD

This section provides practical, compliance-oriented guidance for healthcare professionals considering or currently practicing hirudotherapy in the United States. Content covers the FDA regulatory framework, state scope-of-practice requirements, clinical protocols, safety standards, and practice management.

Legal Notice

Information in this section is for educational reference only and does not constitute legal or medical advice. Practitioners must verify current state regulations, institutional policies, and FDA guidance applicable to their specific practice setting.

Practice Topics

FDA Reference

Regulatory Framework

FDA 510(k) clearances, CBER transfer, state medical practice laws, and international regulatory landscape.

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State-Dependent

Scope of Practice

State-by-state scope guide: MD/DO, NP, PA, ND, RN — who can legally perform hirudotherapy.

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Protocol

Clinical Protocols

Treatment protocols, application sites, dosing guidance, and session management.

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Essential

Safety & Infection Control

Aeromonas prophylaxis, bleeding management, waste disposal, and universal precautions.

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Reference

Insurance & Coding

CPT codes, ICD-10, Aetna CPB 0556, Medicare/Medicaid coverage, and reimbursement strategies.

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Education

Practitioner Training

Education pathways, CME requirements, and credentialing considerations.

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Business

Building a Practice

Business models, equipment, compliance requirements, and financial considerations.

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Protocol

Nursing Protocols

RN delegation, standing orders, and nursing-specific procedural guidelines.

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Related Resources

Safety Protocols

Comprehensive safety framework including Aeromonas management.

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Clinical Specialties

Evidence by medical discipline.

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Resources

Consent forms, checklists, and templates.

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This website provides educational information and does not constitute medical advice, diagnosis, or treatment recommendations. Medicinal leech therapy carries clinically meaningful risks and should be performed only by qualified clinicians under institutionally approved protocols. FDA 510(k) clearance for medicinal leeches is limited to specific indications; investigational and off-label discussions are labeled accordingly. For patient-specific guidance, consult a qualified healthcare provider.