CurrentHealthy Blue LouisianaPolicy BLAPEC-2837-21

Skin Substitutes for Chronic Diabetic Lower Extremity Ulcers

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Healthy Blue Louisiana Medicaid coverage and prior authorization for skin substitutes used to treat partial- and full-thickness diabetic lower extremity ulcers when clinical eligibility, treatment limitations, and documentation requirements are met.

Policy Summary

PayerHealthy Blue Louisiana

PolicySkin Substitutes for Chronic Diabetic Lower Extremity Ulcers

Policy CodePolicy BLAPEC-2837-21

Change TypeAdded coverage and prior authorization requirements

Effective DateDecember 16, 2021

Next Review DateN/A

Key ActionObtain prior authorization before providing skin substitute treatment.

SourceLink

POLICY UPDATE CHANGES

Healthy Blue will cover skin substitutes as medically necessary for partial- and full-thickness diabetic lower extremity ulcers when the stated eligibility criteria are met.

Prior authorization is required for skin substitute treatment for chronic diabetic lower extremity ulcers.

≥1.0 cm²Minimum ulcer size

≥4 weeksMinimum ulcer persistence

≤9%HbA1c threshold

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CurrentHealthy Blue LouisianaPolicy BLAPEC-2837-21

Skin Substitutes for Chronic Diabetic Lower Extremity Ulcers

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Sign up for healthybluelouisiana Policy BLAPEC-2837-21 alerts

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Policy Summary

PayerHealthy Blue Louisiana

PolicySkin Substitutes for Chronic Diabetic Lower Extremity Ulcers

Policy CodePolicy BLAPEC-2837-21

Change TypeAdded coverage and prior authorization requirements

Effective DateDecember 16, 2021

Next Review DateN/A

Key ActionObtain prior authorization before providing skin substitute treatment.

SourceLink

POLICY UPDATE CHANGES

Healthy Blue will cover skin substitutes as medically necessary for partial- and full-thickness diabetic lower extremity ulcers when the stated eligibility criteria are met.

Prior authorization is required for skin substitute treatment for chronic diabetic lower extremity ulcers.

≥1.0 cm²Minimum ulcer size

≥4 weeksMinimum ulcer persistence

≤9%HbA1c threshold

Maximum treatments per 12 weeks

5Applications without measurable healing

Eligibility and Treatment Limits

Treatment limitations and continuation

Covered treatment remains subject to all of the following limitations.

Treatment limitations

Frequency limit: Coverage is limited to a maximum of 10 treatments within a 12-week period.≤10 treatments per 12 weeks
Response requirement: After five applications, further applications require a measurable decrease in ulcer surface area or depth.Measurable decrease after five applications
Comprehensive plan: The treatment plan includes weight offloading, smoking cessation counseling and/or medications if applicable, edema control, improvement in diabetes control and nutritional status, and identification and treatment of wound-healing comorbidities such as infection monitoring.
Product and modality use: Providers may change products, but more than one product may not be used simultaneously for the diabetic lower extremity ulcers, and hyperbaric oxygen therapy may not be used at the same time as skin substitute treatment.No simultaneous multiple products or concurrent hyperbaric oxygen therapy

Coverage excludes treatment when the ulcer is on a foot with active Charcot deformity or a major structural abnormality. Coverage is also excluded for active and untreated autoimmune connective tissue disease, known or suspected ulcer malignancy, concurrent radiation therapy or chemotherapy, or retreatment of the same ulcer within one year.

Providers may change the product used, but simultaneous use of more than one skin substitute product for diabetic lower extremity ulcers is not covered. Hyperbaric oxygen therapy is also not covered when administered at the same time as skin substitute treatment.

If there is no measurable decrease in ulcer surface area or depth after five applications, further applications are not covered, even when the treatment was previously authorized.

Clinical Thresholds

Ulcer size

Minimum ulcer sizeAt least 1.0 square centimeter (cm²)

Ulcer duration

Minimum persistenceAt least four weeks

HbA1c

HbA1c requirement≤9% within the last 90 days, or a documented plan to improve HbA1c to 9% or below as soon as possible

Ankle-brachial index

Minimum ABI

Authorization, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required before skin substitute treatment. Submit medical documentation demonstrating that the enrollee meets all applicable eligibility requirements. Prior authorization does not override the five-application measurable-healing limit.

Documentation Required

Clinical Eligibility Documentation

Document that every clinical eligibility requirement is satisfied before treatment, including the qualifying ulcer, diabetes diagnosis and glycemic status, adequate circulation, comprehensive wound therapy, absence of infection or disqualifying depth, and no applicable exclusion.

Lower-extremity ulcer is at least 1.0 cm² and has persisted at least four weeks.
No measurable healing despite comprehensive therapy, including moist dressings, debridement when indicated, and weight offloading.
Type 1 or type 2 diabetes and HbA1c ≤9% within the last 90 days, or a documented plan to reach ≤9% as soon as possible.

Policy Context

This policy addresses the use of skin substitutes for partial- and full-thickness diabetic lower extremity ulcers that remain refractory despite comprehensive wound care. Eligibility requires appropriate wound management, including moist wound dressings, debridement of necrotic tissue when present, and weight offloading, together with adequate circulation, glycemic management, infection control, and documentation of a comprehensive treatment plan. Treatment is subject to prior authorization, response-based continuation limits, and restrictions on concurrent products and hyperbaric oxygen therapy.

Clinical Definitions

Measurable signs of healing

Qualifying healing changeA decrease in wound surface area and depth, or a decreased amount of exudate and necrotic tissue

Adequate circulation

ABIAt least 0.7

TBIAt least 0.5

Dorsum TcPO2At least 30 mm Hg

Doppler waveformTriphasic or biphasic Doppler arterial waveforms at the ankle of the affected leg

Policy Summary

PayerHealthy Blue Louisiana

PolicySkin Substitutes for Chronic Diabetic Lower Extremity Ulcers

Policy CodePolicy BLAPEC-2837-21

Change TypeAdded coverage and prior authorization requirements

Effective DateDecember 16, 2021

Next Review DateN/A

Key ActionObtain prior authorization before providing skin substitute treatment.

SourceLink

On This Page

Toe-brachial index

Minimum TBIAt least 0.5

Dorsum transcutaneous oxygen

Minimum dorsum TcPO2At least 30 mm Hg

No untreated wound infection or underlying bone infection; depth must comply with the product indication.

Document that none of the listed clinical exclusions or same-ulcer retreatment restrictions apply.

Documentation Required

Perfusion Documentation

Document adequate circulation to the affected extremity using at least one accepted measurement or waveform finding.

ABI ≥0.7.
TBI ≥0.5.
Dorsum TcPO2 ≥30 mm Hg.
Triphasic or biphasic Doppler arterial waveforms at the ankle of the affected leg.

Documentation Required

Comprehensive Wound Treatment Plan

Maintain and document a comprehensive treatment plan for every ulcer, addressing wound care and modifiable factors that may affect healing.

Offloading of weight.
Smoking-cessation counseling and/or medications, if applicable.
Edema control.
Improvement in diabetes control and nutritional status.
Identification and treatment of other wound-healing comorbidities, including ongoing monitoring for infection.

Documentation Required

Serial Wound Measurements

Record serial ulcer measurements throughout treatment to establish measurable healing. Documentation must track changes in both surface area and depth over time, along with other clinical healing indicators when applicable.

Document ulcer surface area and depth at baseline and after applications.
Measurable healing may include decreased surface area and depth or decreased exudate and necrotic tissue.
Use the serial measurements to support continued treatment and determine whether further applications remain covered.

Denial Risk

Ulcer Does Not Meet Baseline Criteria

The ulcer is ineligible when baseline size, duration, or healing requirements are not met. Coverage requires a lower-extremity ulcer of at least 1.0 cm² that has persisted for at least four weeks and has not shown measurable healing despite comprehensive therapy.

Deny or consider ineligible ulcers smaller than 1.0 cm².
Deny or consider ineligible ulcers present for less than four weeks.
Deny or consider ineligible treatment when measurable healing is documented or comprehensive therapy has not been provided and documented.

Denial Risk

Diabetes or Perfusion Criteria Are Not Met

Eligibility is not met when the member lacks the required diabetes diagnosis, does not meet the HbA1c requirement or improvement-plan alternative, or lacks documented adequate circulation.

Type 1 or type 2 diabetes mellitus is required.
HbA1c must be ≤9% within the last 90 days, or there must be a documented plan to improve it to ≤9% as soon as possible.
At least one accepted perfusion finding is required: ABI ≥0.7, TBI ≥0.5, dorsum TcPO2 ≥30 mm Hg, or triphasic/biphasic ankle Doppler waveforms.

Denial Risk

Infection or Excessive Wound Depth

Treatment is ineligible when there is an untreated wound infection or underlying bone infection, or when the ulcer extends beyond permitted tissue depth. Follow the individual product indication for ulcers with exposed sinus tracts or involvement of deeper structures.

No untreated wound infection or osteomyelitis/underlying bone infection.
Ulcer must not extend to tendon, muscle, joint capsule, or bone unless the product indication allows that application.
Exposed sinus tracts are not eligible unless allowed by the product indication.

Denial Risk

Clinical Exclusion Conditions

Do not treat when a listed clinical exclusion applies. These exclusions include certain foot deformities, autoimmune disease, malignancy, cancer therapy, or recent treatment of the same ulcer.

Active Charcot deformity or major structural foot abnormality when the ulcer is on the foot.
Active and untreated autoimmune connective tissue disease.
Known or suspected malignancy of the ulcer.
Current radiation therapy or chemotherapy.
Re-treatment of the same ulcer within one year.

Billing Rule

Treatment Limits or Inadequate Response

Coverage is limited to a maximum of 10 treatments within a 12-week period. Further applications are not covered when there is no measurable decrease in ulcer surface area or depth after five applications, even if those applications were prior authorized.

Maximum: 10 treatments in any 12-week period.
After five applications without measurable decrease in surface area or depth, stop further applications for coverage purposes.
Use serial measurements to demonstrate response before continuing treatment.

Billing Rule

Concurrent Treatment Restrictions

Providers may change products used for diabetic lower-extremity ulcers, but simultaneous use of more than one skin substitute product is not covered. Hyperbaric oxygen therapy is also not covered when provided at the same time as skin substitute treatment.

Do not use more than one skin substitute product concurrently for the same diabetic lower-extremity ulcer treatment course.
Do not provide hyperbaric oxygen therapy concurrently with skin substitute treatment.