CurrentCignaPolicy IP0143

Collagenase clostridium histolyticum (Xiaflex) intralesional injection

Cigna coverage policy governing medical necessity and coding for Xiaflex injections for Dupuytren's contracture and Peyronie's disease for members covered by Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyCollagenase clostridium histolyticum (Xiaflex) intralesional injection

Policy CodePolicy IP0143

Change TypeCoding updatesminor formatting revisions

Effective DateFeb 28, 2025

Next Review DateN/A

Key ActionObtain prior authorization demonstrating medical necessity and adherence to dosing and maximum injection limits.

SourceLink

POLICY UPDATE CHANGES

Added CPT code 20527 to coding section.

Removed CPT 26341 from coding.

No criteria changes; minor updates to policy format.

2Indications covered

0.58 mgDose per injection

3Max injections per cord

8Max injections per plaque

20527, J0775Key billing codes

Policy Summary

PayerCigna

PolicyCollagenase clostridium histolyticum (Xiaflex) intralesional injection

Policy CodePolicy IP0143

Change TypeCoding updatesminor formatting revisions

Effective DateFeb 28, 2025

Next Review DateN/A

Key ActionObtain prior authorization demonstrating medical necessity and adherence to dosing and maximum injection limits.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria

Dupuytren's Contracture

Covered when ALL of the following are met:

Dupuytren's Contracture Criteria

Age 18 years or older
B: Treatment of symptomatic Dupuytren's contracture with BOTH presence of a palpable cord AND functional impairment as manifested by an MCP or PIP joint contracture of 20 degrees or greater at baseline (prior to initial injection)MCP/PIP ≥ 20 degrees
C: As part of the current treatment course, the individual will NOT be treated with more than a total of three injections (maximum) per affected cord≤ 3 injections per cord
Subsequent doses for each affected cord are administered no sooner than 4 weeks after the previous injection. A maximum of two cords (up to 1.16 mg) may be injected per treatment visit; additional cords may be treated on a different day.
D: Medication is administered by a healthcare provider experienced in injection procedures of the hand and in the treatment of Dupuytren's contracture
Dose per injection = 0.58 mg into an affected cord.

Peyronie's Disease

Covered when ALL of the following are met:

Peyronie's Disease Criteria

Age 18 years or older
B: Presence of a palpable plaque
C
- Ci: At baseline (prior to initial injection), penile curvature deformity of at least 30 degrees≥ 30 degrees
- Cii: Individual who has received prior treatment with Xiaflex and has a penile curvature deformity of at least 15 degrees

Use of collagenase clostridium histolyticum (Xiaflex) for any indication other than Dupuytren's contracture or Peyronie's disease is considered experimental, investigational, or unproven and is not covered. This includes cosmetic uses such as treatment of cellulite and other non‑approved indications.

Retreatment for Peyronie's disease beyond one treatment course—defined as more than 8 injections per plaque—is considered unproven. The safety of administering more than one treatment course (more than 8 injections per plaque) is unknown and such retreatment is not covered.

Coding

Covered CPT CodesCPTCovered

20527

Injection, enzyme (eg, collagenase), palmar fascial cord (ie, Dupuytren's contracture).

Covered HCPCS CodesHCPCSCovered

J0775

Injection, collagenase clostridium histolyticum, 0.01 mg

inv-07: Dupuytren's contracture joint contracture threshold

ThresholdMCP or PIP joint contracture of 20 degrees or greater at baseline (prior to initial injection)

Maximum injections per affected cordNo more than 3 injections per affected cord during the current treatment course

Age requirementPatient must be 18 years or older

Provider qualificationMedication must be administered by a healthcare provider experienced in injection procedures of the hand and treatment of Dupuytren's contracture

inv-08: Peyronie's disease curvature threshold

Baseline curvature threshold (initial treatment)Penile curvature deformity of at least 30 degrees at baseline prior to initial injection

Provider Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must demonstrate that medical necessity criteria are met for the specific indication (Dupuytren's contracture or Peyronie's disease) and that dosing and maximum injection limits in the policy are followed.

PA must document indication-specific criteria and adherence to dosing/maximum injections

Step Therapy

No step therapy requirements are specified for Xiaflex.

Documentation Required

Required Clinical Documentation

Provide documentation supporting the clinical criteria below at the time of prior authorization: age (≥18 years), evidence of palpable cord (Dupuytren's) or palpable plaque (Peyronie's), baseline objective measurement of contracture/curvature, prior treatment history, and planned dosing schedule consistent with policy limits.

Background

Xiaflex (collagenase clostridium histolyticum) is a combination of bacterial collagenases indicated for adults with Dupuytren's contracture with a palpable cord and for Peyronie's disease with a palpable plaque and sufficient penile curvature. Its mechanism involves enzymatic degradation of collagen in the fibrotic cord or plaque to reduce contracture or curvature; clinical use and trial inclusion criteria inform the policy thresholds for baseline contracture/curvature and dosing limits.

Definitions

inv-14: Palpable cord / plaque

DefinitionA discrete fibrous band in the palm (cord) for Dupuytren's contracture or a fibrotic lesion in the tunica albuginea (plaque) for Peyronie's disease that can be detected on physical exam and targeted for intralesional injection

Clinical detectionDetected by physical examination as a palpable abnormality (cord in the palm; plaque in the penis)

Relevance to coveragePresence of a palpable cord is required for Dupuytren's coverage; presence of a palpable plaque is required for Peyronie's coverage

Target for injectionThese palpable structures are the intended intralesional targets for the 0.58 mg Xiaflex injections

≥ 15 degrees for retreatment

D: Will NOT be treated with more than a total of 8 injections (maximum) per Peyronie's plaque≤ 8 injections per plaque

(Four cycles; each cycle = two 0.58 mg injections given 1–3 days apart; cycles separated by at least 6 weeks). The safety of more than one treatment course (more than 8 injections) is unknown.

E: Medication is administered by a healthcare provider experienced in the treatment of male urological diseases

Dose per injection = 0.58 mg; one treatment course consists of four cycles (up to 8 injections).

Retreatment curvature thresholdIf individual has received prior treatment with Xiaflex, penile curvature deformity of at least 15 degrees for retreatment

Maximum injections per plaqueUp to 8 injections per Peyronie's plaque (four dosing cycles; each cycle = two 0.58 mg injections 1–3 days apart)

Cycle spacingCycles are separated by at least 6 weeks; do not exceed one treatment course (8 injections) as safety beyond that is unknown

Age ≥ 18 documented
For Dupuytren's: presence of a palpable cord; baseline MCP or PIP contracture measurement ≥ 20°
For Peyronie's: presence of a palpable plaque; baseline penile curvature ≥ 30° prior to initial injection (or ≥ 15° if previously treated with Xiaflex)
Planned number of injections and schedule consistent with policy maximums (Dupuytren's: ≤3 injections per affected cord; Peyronie's: ≤8 injections per plaque; dosing intervals as specified)
Provider experience: administering clinician experienced in hand injection procedures (Dupuytren's) or in male urological disease treatment (Peyronie's)

Denial Risk

Not Covered Indications

Use of collagenase clostridium histolyticum (Xiaflex) for indications other than Dupuytren's contracture or Peyronie's disease is considered experimental, investigational, or unproven and is not covered. This includes cosmetic uses (e.g., treatment of cellulite) and retreatment beyond the policy-specified limits for Peyronie's disease.

Cosmetic uses (e.g., cellulite of buttocks) — not covered
Retreatment for Peyronie's disease beyond one treatment course (more than 8 injections per plaque) — not covered