CurrentConnectiCarePolicy C15159-C

Santyl (collagenase) Coverage Criteria

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Coverage and prior authorization requirements for topical Santyl (collagenase) used to debride chronic dermal ulcers and severely burned areas under the applicable pharmacy or medical benefit.

Policy Summary

PayerConnectiCare

PolicySantyl (collagenase) Coverage Criteria

Policy CodePolicy C15159-C

Change TypeNo material change

Effective DateMay 30, 2026

Next Review DateApril 1, 2027

Key ActionSubmit documentation of the covered diagnosis, wound characteristics, Santyl use for debridement, and appropriate wound care for prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

30g/30 daysStandard quantity limit

>30g/30 daysSpecialist threshold

2 monthsInitial authorization

Up to 2 monthsContinuation authorization

Contraindicated

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CurrentConnectiCarePolicy C15159-C

Santyl (collagenase) Coverage Criteria

Customize your policy alerts

Sign up for ConnectiCare Policy C15159-C alerts

Get alerted when Policy C15159-C changes without checking for updates manually.

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Coverage and prior authorization requirements for topical Santyl (collagenase) used to debride chronic dermal ulcers and severely burned areas under the applicable pharmacy or medical benefit.

Policy Summary

PayerConnectiCare

PolicySantyl (collagenase) Coverage Criteria

Policy CodePolicy C15159-C

Change TypeNo material change

Effective DateMay 30, 2026

Next Review DateApril 1, 2027

Key ActionSubmit documentation of the covered diagnosis, wound characteristics, Santyl use for debridement, and appropriate wound care for prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

30g/30 daysStandard quantity limit

>30g/30 daysSpecialist threshold

2 monthsInitial authorization

Up to 2 monthsContinuation authorization

Contraindicated

Collagenase hypersensitivity

Coverage Criteria

Initial Therapy

Covered for all indications when all of the following are met:

Initial therapy criteria: The member has a documented diagnosis of chronic dermal ulcers or severely burned areas; the wound description includes size, location, and tissue content, such as the percentage of necrotic versus granulation tissue; Santyl is being used for wound debridement; and appropriate general wound-care measures are being taken.

The wound should be cleansed of debris and digested material before Santyl application. When infection is present, an appropriate topical antibiotic powder should be used before Santyl application.

Continuation Therapy

Continuation of therapy requires all of the following:

Continuation criteria: Documentation shows wound improvement and wound debridement remains incomplete.

Incomplete debridement may be demonstrated by continued presence of necrotic tissue without well-established granulation tissue.

All other uses of Santyl (collagenase) are considered experimental or investigational and are subject to the payer’s applicable Off-Label policy.

Santyl is excluded for patients with local or systemic hypersensitivity to collagenase.

Billing and Coding

HCPCS CODEHCPCS

Authorization and Documentation Requirements

Prior Authorization

Clinical Prior Authorization Criteria

Submit clinical documentation supporting the covered diagnosis, wound characteristics, use of Santyl for wound debridement, and appropriate general wound-care measures.

Documented diagnosis of a chronic dermal ulcer or severely burned area.
Wound description, including size, location, and tissue content.
Santyl is being used for wound debridement.
Appropriate wound-care measures are being taken, including cleansing debris and digested material before application and, when infection is present, use of an appropriate topical antibiotic powder before Santyl.

Prior Authorization

Specialist Requirement for Higher Quantities

Requests for quantities greater than 30g per 30 days must be prescribed by or made in consultation with a wound care specialist, infectious disease specialist, or dermatologist.

Applies only to requests exceeding 30g per 30 days.

Santyl Overview

Santyl (collagenase) is a topical enzymatic debriding agent used to remove devitalized tissue from chronic dermal ulcers and severely burned areas.

Initial Authorization

Initial Therapy

Initial authorization is for 2 months when all required medical information is documented:

Initial therapy: The member has a documented diagnosis of chronic dermal ulcers or severely burned areas; the wound description includes size, location, and tissue content, such as the percentage of necrotic versus granulation tissue; Santyl is being used for wound debridement; and appropriate general wound-care measures are being taken.

The wound should be cleansed of debris and digested material before Santyl application. When infection is present, an appropriate topical antibiotic powder should be used before Santyl application.

Continuation Authorization

Continuation of Therapy

Continuation therapy is authorized for up to 2 months when all criteria are met:

Continuation therapy: Documentation shows that the wound is improving and wound debridement remains incomplete.

Incomplete debridement may be demonstrated by continued presence of necrotic tissue without well-established granulation tissue.

Quantity and Dosing Limits

Quantity Limits

Standard quantity limit30g (1 tube) every 30 days

Quantity Limits

Larger quantity requestsUse the Santyl dosing calculator for requests for larger quantities

Applicable Site of Care

Billing Rule

Administer topical therapy under the applicable benefit

Topical medication may be covered under the pharmacy or medical benefit and may be self-administered by the patient or administered as a topical product in a non-hospital facility-based location.

Billing Rule

Use a non-hospital facility-based location

Topical Santyl may be administered as a topical product in a non-hospital facility-based location.

Policy Summary

PayerConnectiCare

PolicySantyl (collagenase) Coverage Criteria

Policy CodePolicy C15159-C

Change TypeNo material change

Effective DateMay 30, 2026

Next Review DateApril 1, 2027

Key ActionSubmit documentation of the covered diagnosis, wound characteristics, Santyl use for debridement, and appropriate wound care for prior authorization.

SourceLink

On This Page

Documentation Required

General Records and Provider Documentation

The payer may require additional documentation for coverage determination, quality improvement, and fraud, waste, and abuse prevention.

Patient records and test results.
Credentials of the provider ordering or performing the drug or service.

Documentation Required

Initial Clinical Documentation

For initial requests, document the covered diagnosis and complete wound characteristics, along with the clinical rationale for Santyl and the wound-care plan.

Chronic dermal ulcers or severely burned areas.
Wound size and location.
Tissue content, including the percentage of necrotic versus granulation tissue.
Santyl use for wound debridement.
Other appropriate general wound-care measures.

Documentation Required

Continuation Documentation

For continuation of therapy, submit evidence that the wound is improving and that debridement remains incomplete.

Document wound improvement.
Document persistent incomplete debridement, such as continued necrotic tissue without well-established granulation tissue.

Unsupported block type: documentation

Denial Risk

Insufficient Supporting Documentation

Coverage or reimbursement may be denied when submitted documentation does not support medical necessity, a covered use, or non-investigational use within the member's benefits.

The payer may take additional appropriate action when documentation is insufficient or billing or other practices are inappropriate or excessive.

Denial Risk

Incomplete Clinical Documentation

Requests may be denied or require additional review when the diagnosis, wound characteristics, Santyl debridement use, or wound-care documentation is incomplete.

Include the diagnosis and wound size, location, and tissue content.
Document Santyl use for debridement and appropriate general wound-care measures.

Denial Risk

Other Uses Are Experimental or Investigational

Uses of Santyl other than the covered indications are considered experimental or investigational and are subject to the payer's applicable off-label policy.

Denial Risk

Collagenase Hypersensitivity

Do not use Santyl in patients with local or systemic hypersensitivity to collagenase.

Note

Discontinue When Infection Persists or Wound Goals Are Met

If an infection does not respond to appropriate treatment, discontinue Santyl until the infection is in remission. Terminate therapy when debridement of necrotic tissue is complete and granulation tissue is well established.

Use an appropriate topical antibiotic powder before Santyl when infection is present, as appropriate.