CurrentMassachusetts Executive Office of Health and Human ServicesPolicy N/A

Guidelines for Medical Necessity Determination for Skin Substitutes

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This guideline explains the clinical information MassHealth uses to determine medical necessity for specified skin-substitute products for adults with diabetic foot ulcers and venous leg ulcers. It identifies products that do and do not require prior authorization, coverage criteria, non-coverage circumstances, documentation requirements, and submission procedures.

Policy Summary

PayerMassachusetts Executive Office of Health and Human Services

PolicyGuidelines for Medical Necessity Determination for Skin Substitutes

Policy CodePolicy N/A

Change TypeNo material change

Effective DateFebruary 7, 2024

Next Review DateN/A

Key ActionSubmit prior-authorization requests and supporting documentation electronically through the Provider Online Service Center (POSC).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

16 weeksMaximum PA therapy period

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CurrentMassachusetts Executive Office of Health and Human ServicesPolicy N/A

Guidelines for Medical Necessity Determination for Skin Substitutes

Customize your policy alerts

Sign up for all Massachusetts Executive Office of Health and Human Services policy alerts

Know when Massachusetts Executive Office of Health and Human Services releases new policies or updates existing guidance.

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Policy Summary

PayerMassachusetts Executive Office of Health and Human Services

PolicyGuidelines for Medical Necessity Determination for Skin Substitutes

Policy CodePolicy N/A

Change TypeNo material change

Effective DateFebruary 7, 2024

Next Review DateN/A

Key ActionSubmit prior-authorization requests and supporting documentation electronically through the Provider Online Service Center (POSC).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

16 weeksMaximum PA therapy period

Maximum product frequency

4 weeksStandard-of-care treatment before graft

18+ yearsMinimum member age

1–25 cm²Required wound area

104 weeksMaximum wound duration

Clinical Coverage Criteria and Exclusions

Initial and continuing clinical coverage

Covered when all applicable criteria are met.

Eligible wound and prior treatment: Member has a chronic, noninfected diabetic foot ulcer or venous leg ulcer that failed documented standard-of-care treatment for at least four weeks (30 days), with documented compliance. Failure requires increased size or depth, no change from baseline, and no sign that improvement is likely. Measurements must be documented initially, after at least four weeks of standard care, and immediately before graft placement.minimum 4 weeks / 30 days

General member and wound criteria: Member is at least 18 years old, has a wound index of 1 to 25 cm², has no ulcer within 3 cm of the index ulcer, and has an ABI between 0.7 and 1.2.age 18+; wound 1-25 cm²; ABI 0.7-1.2

DFU-specific criteria: For a DFU, the member has been assessed for type 1 versus type 2 diabetes and management history, including relevant comorbidities; HbA1c is less than 12% within 90 days of PA submission; serum creatinine is less than 3.0 mg/dL; diet, nutrition, activity level, off-loading device use, and appropriate footwear have been assessed.HbA1c <12% within 90 days; creatinine <3.0 mg/dL

Apply only when the wound is a DFU.

VLU-specific criteria: For a VLU, the member has clinical-history and physical-exam assessment, diagnostic testing or clinical evidence addressing venous reflux, perforator incompetence, thrombosis, or characteristic venous disease, and standard-of-care treatment continues for at least four weeks with ongoing compression therapy.at least 4 weeks with ongoing compression

Apply only when the wound is a VLU.

Implemented wound treatment: Treatment includes debridement as appropriate, off-loading for DFUs, compression for VLUs, infection control, exudate management and maintenance of a moist environment, and evaluation by an experienced wound clinician.all listed treatment components as applicable

Off-loading applies to DFUs; compression applies to VLUs.

Smoking status or cessation: Member is a nonsmoker, has refrained from smoking for at least six weeks before treatment, or is undergoing smoking-cessation treatment.6 weeks abstinence when applicable

Smoking history and counseling must be documented.

Treatment adherence and response: Member is able to follow the treatment plan, and the ulcer improves significantly over six weeks of skin-substitute treatment. Continued significant improvement is required every six weeks for ongoing applications.significant improvement every 6 weeks

Pregnancy precaution

Pregnancy requires additional informed consent.

Pregnancy counseling: If the member is pregnant, provide informed consent because these products have largely not been tested in pregnancy.informed consent

Coverage is not provided when the member is younger than 18.

Coverage is not provided when the ulcer penetrates into muscle, tendon, or bone.

Coverage is not provided when there are signs of ulcer infection, bone infection, active Charcot arthropathy, or active vasculitis of the ulcer extremity.

Coverage is not provided when the ulcer is located on the dorsum of the foot.

Coverage is not provided when more than 50% of the ulcer is below the malleolus.

Coverage is not provided when the member received negative-pressure wound therapy or hyperbaric oxygen therapy within the last 7 days, or treatment with another advanced wound-care product within the past 30 days.

Coverage is not provided for an uncontrolled infection, including bacteremia or osteomyelitis.

Coverage is not provided when the member is receiving immunosuppressants or corticosteroids.

Coverage is not provided when the member is taking COX-2 inhibitors.

Coverage is not provided for wounds with severity greater than Wagner II, including ulcers with deep bone involvement or gangrene.

Coverage is not provided when more than the manufacturer's recommended application procedures have been performed during the episode of skin replacement surgery.

Coverage is not provided for repeat skin-substitute graft applications when a previous application was unsuccessful. Unsuccessful treatment means the ulcer has increased in size or depth, had no change from baseline size or depth, and shown no sign of improvement or indication that improvement is likely, such as granulation, epithelialization, or progress toward closing.

Coverage is not provided when wound duration is beyond 104 weeks (2 years).

Covered Products, Prior Authorization, and Clinical Thresholds

DFU products not requiring prior authorizationHCPCSCovered

Q4101	Apligraf
Q4186	Epifix
Q4106	Dermagraft

DFU products requiring prior authorizationHCPCSCovered

Q4133	Grafix prime or Grafixpl prime
Q4151	Amnioband
Q4159	Affinity
Q4196	Puraply

VLU products not requiring prior authorizationHCPCSCovered

Q4186	Epifix
Q4191	Apligraf

VLU products requiring prior authorizationHCPCSCovered

Q4133	Grafix prime or Grafixpl prime
Q4151	Amnioband
Q4159	Affinity
Q4196	Puraply

PA treatment duration

Authorization periodPrior authorization is granted for 16 weeks from the date of approval.

Product limitCoverage is limited to a maximum of one unit per week.

Additional unitsA new prior-authorization request must be submitted if additional units are needed.

Product frequency

Maximum frequencyOne unit per week.

Applicable productsThe one-unit-per-week limit applies to products covered under the diabetic foot ulcer and venous leg ulcer guidelines.

Prior Authorization, Documentation, and Denial Risks

Prior Authorization

DFU Products Requiring Prior Authorization

For adults with diabetic foot ulcers, prior authorization is required before treatment with the following skin substitutes. Each approved product is limited to one unit per week.

Grafix prime or Grafixpl prime (Q4133)
Amnioband (Q4151)
Affinity (Q4159)
Puraply (Q4196)

Prior Authorization

VLU Products Requiring Prior Authorization

For adults with venous leg ulcers, prior authorization is required before treatment with the following skin substitutes. Each approved product is limited to one unit per week.

Grafix prime or Grafixpl prime (Q4133)
Amnioband (Q4151)
Affinity (Q4159)
Puraply (Q4196)

Policy Background

Skin substitutes are cellular- and tissue-based products derived from human tissue, nonhuman tissue, synthetic materials, or combinations of these sources. They replicate functional and structural characteristics of normal skin and may provide temporary or permanent coverage for partial- or full-thickness wounds. Under this guideline, they are used as an adjunct to standard care for chronic neuropathic diabetic foot ulcers and venous leg ulcers, with appropriate wound-care measures such as debridement, off-loading for diabetic foot ulcers, compression for venous leg ulcers, infection control, exudate management, and maintenance of a moist wound environment.

Key Definitions

Skin substitute

Source materialsCellular- and tissue-based products may be derived from human tissue, nonhuman tissue, synthetic materials, or a composite of these sources.

Functional purposeThe products replicate the functional and structural characteristics of normal skin.

Clinical useSkin substitutes are used as adjuncts in managing partial- and full-thickness wounds, including diabetic and chronic venous ulcers.

Unsuccessful treatment

Wound changeUnsuccessful treatment includes an ulcer that has increased in size or depth after a prior skin-substitute application.

No baseline changeIt also includes an ulcer with no change in baseline size or depth.

Policy Summary

PayerMassachusetts Executive Office of Health and Human Services

PolicyGuidelines for Medical Necessity Determination for Skin Substitutes

Policy CodePolicy N/A

Change TypeNo material change

Effective DateFebruary 7, 2024

Next Review DateN/A

Key ActionSubmit prior-authorization requests and supporting documentation electronically through the Provider Online Service Center (POSC).

SourceLink

On This Page

Additional unitsAdditional units require a new prior-authorization request.

Standard-of-care treatment before graft

Minimum treatment periodThe ulcer must fail documented standard-of-care treatment for a minimum of four weeks.

Defined durationFour weeks is defined as 30 days.

Required measurementsDocument measurements initially, after at least four weeks of standard-of-care treatment, and immediately before graft placement.

Member age

Minimum ageThe member must be 18 years of age or older.

Coverage exclusionMembers younger than 18 are not eligible for coverage.

ApplicabilityThe age requirement applies to skin-substitute graft coverage for diabetic foot ulcers and venous leg ulcers.

Wound index area

Required wound areaThe wound index must measure from 1 to 25 cm².

Nearby-ulcer requirementThere must be no ulcer within 3 cm of the index ulcer.

Coverage criterionThe wound index requirement applies to the member receiving the skin-substitute graft.

Ankle Brachial Index

Required ABI rangeThe Ankle Brachial Index must be between 0.7 and 1.2.

MeasurementThe ABI level must be documented as part of the clinical coverage assessment.

Coverage criterionThe ABI range is a required member and wound criterion for skin-substitute graft coverage.

DFU HbA1c

HbA1c thresholdFor a diabetic foot ulcer, HbA1c must be less than 12%.

TimingThe HbA1c result must be from within 90 days of prior-authorization submission.

ApplicabilityThis requirement applies specifically to members with diabetic foot ulcers.

DFU serum creatinine

Creatinine thresholdFor a diabetic foot ulcer, serum creatinine must be less than 3.0 mg/dL.

ApplicabilityThe serum-creatinine requirement applies specifically to members with diabetic foot ulcers.

Clinical assessmentSerum creatinine is one of the disease-specific assessments required for DFU coverage.

Smoking abstinence

Required abstinenceA member who previously smoked should refrain from smoking for at least six weeks before treatment.

Alternative statusThe member may qualify as a nonsmoker.

Smoking-cessation treatmentThe member may alternatively be undergoing treatment for smoking cessation; smoking history and counseling must be documented.

Wound duration exclusion

Duration limitCoverage is excluded when wound duration is beyond 104 weeks.

Equivalent period104 weeks is two years.

Coverage statusA wound beyond this duration is a non-coverage circumstance for a skin-substitute graft.

Unsupported block type: billing_rule

Documentation Required

Required Clinical Documentation

Submit clinical information showing that the member meets the coverage criteria. The documentation must be submitted by the MassHealth-enrolled surgeon performing the procedure and must support medical necessity.

Include the primary diagnosis name and condition-specific HCPCS code.
Document the diagnosis date, past treatment course, and current plan of care.
Include relevant diagnostic studies and laboratory tests from the last year; medications received during the last three to six months; current comorbidities, surgeries, procedures, and functional status; substance-use and tobacco history; and clinical photographs with measurements for each subsequent submission, including prior photographs.
Document compliance with prescribed treatment and all clinical criteria supporting the intended procedure.

Documentation Required

Evidence Supporting Clinical Criteria

Demonstrate that the wound is a chronic, noninfected DFU or VLU that failed documented standard-of-care treatment for at least four weeks (30 days), with documented compliance. Failure means the ulcer increased in size or depth, remained unchanged from baseline, or showed no sign that improvement was likely.

Provide baseline measurements of the ulcer.
Provide measurements after at least four weeks of standard-of-care treatment.
Provide measurements immediately before placement of the skin-substitute graft.
Document applicable standard care, including debridement, DFU off-loading, VLU compression, infection control, exudate management and maintenance of a moist environment, and evaluation by an experienced wound clinician.
For VLUs, document ongoing compression therapy and the relevant venous history, examination, and diagnostic testing.
For DFUs, document diabetes type and management, relevant comorbidities, recent HbA1c and serum creatinine, nutritional and activity status, and off-loading or appropriate footwear.
Document smoking status and cessation counseling, and the member's ability to follow the treatment plan.

Documentation Required

Submit Through the POSC

Clinical information and all supporting documentation must be submitted electronically by the MassHealth-enrolled surgeon performing the procedure through the Provider Online Service Center (POSC).

Providers with a currently approved electronic claims waiver must instead submit the MassHealth PA-1 Form and all supporting documentation.
For POSC access questions, contact MassHealth at (800) 841-2900 or TDD/TTY 711.

Denial Risk

Ineligible Wound or Member

A skin-substitute graft is not medically necessary when the member or wound has an exclusionary clinical condition, including age, excessive depth, infection, or related disease activity.

Member is younger than 18.
Ulcer penetrates muscle, tendon, or bone; is deeper than Wagner II; involves deep bone or gangrene; or has active Charcot arthropathy.
Ulcer shows infection, bone infection, uncontrolled infection such as bacteremia or osteomyelitis, or active vasculitis of the ulcer extremity.
Member is receiving immunosuppressants or corticosteroids or is taking COX-2 inhibitors.
The member cannot follow the treatment plan.

Denial Risk

Location, Duration, and Prior-Treatment Exclusions

Review the wound's location and history before requesting or continuing coverage. These characteristics can independently result in non-coverage.

Ulcer is located on the dorsum of the foot.
More than 50% of the ulcer is below the malleolus.
Wound duration exceeds 104 weeks (two years).
More than the manufacturer's recommended number of applications has been used during the episode of skin-replacement surgery.
Repeat application is requested after a previous skin-substitute application was unsuccessful; unsuccessful treatment means the ulcer increased in size or depth, remained unchanged from baseline, or showed no sign that improvement was likely.

Denial Risk

Recent or Incompatible Treatment

Do not request coverage when the member has received incompatible advanced wound treatment within the policy's restricted look-back periods.

Negative-pressure wound therapy within the last seven days.
Hyperbaric oxygen therapy within the last seven days.
Other advanced wound-care products within the past 30 days.

Denial Risk

Insufficient Medical-Necessity Evidence

A request may be denied when the record does not establish failure of documented standard-of-care treatment. Medical-necessity documentation must show at least four weeks (30 days) of prescribed treatment with documented compliance and objective wound measurements.

Document baseline wound size and depth, measurements after at least four weeks of standard care, and measurements immediately before graft placement.
Explain the lack of response: increased size or depth, no change from baseline, or no granulation, epithelialization, progress toward closure, or other indication that improvement is likely.
Document the required care components, including appropriate debridement, DFU off-loading, VLU compression, infection control, moist-environment and exudate management, and wound-clinician evaluation.
Include clinical photographs with measurements and the relevant history, examination, laboratory, diagnostic, medication, comorbidity, and tobacco information.

Denial Risk

Continuing-Application Response Requirement

For continuing applications, the ulcer must improve significantly over each six-week treatment interval. If significant improvement is not documented during an interval, further applications may be denied.

Measure and document the wound during each six-week interval.
Demonstrate significant improvement before requesting ongoing applications.
Continued coverage requires continued significant improvement every six weeks.

No improvementThe ulcer shows no sign of improvement or indication that improvement is likely, such as granulation, epithelialization, or progress toward closure.