CurrentMassachusetts Executive Office of Health and Human ServicesPolicy N/A

Guidelines for Medical Necessity Determination for Skin Substitutes

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This guideline governs MassHealth medical-necessity review and prior authorization requirements for skin-substitute grafts used primarily for adult diabetic foot ulcers and venous leg ulcers. It applies to MassHealth providers and members, with payment also subject to eligibility, other-insurance, program, and managed-care plan requirements.

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 DateFeb 7, 2024

Next Review DateN/A

Key ActionSubmit prior authorization requests electronically through the Provider Online Service Center for products requiring authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

16 weeksMaximum PA therapy duration

1 unit/week

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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 DateFeb 7, 2024

Next Review DateN/A

Key ActionSubmit prior authorization requests electronically through the Provider Online Service Center for products requiring authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

16 weeksMaximum PA therapy duration

1 unit/week

Application frequency

≥4 weeksStandard-of-care treatment

1–25 cm²Wound index area

0.7–1.2Ankle Brachial Index

Medical Necessity and Coverage Criteria

Initial Therapy

Covered for initial therapy when ALL of the following criteria are met, including the applicable condition-specific criteria.

ALL of the following

Member has a chronic, noninfected diabetic foot ulcer (DFU) or chronic, noninfected venous leg ulcer (VLU) that has failed to respond to documented standard-of-care treatment for at least four weeks (30 days), with documented compliance to prescribed treatment. Failure to respond means the ulcer has increased in size or depth, had no change in baseline size or depth, or shown no sign of improvement or indication that improvement is likely, such as granulation, epithelialization, or progress toward closing.
Document the initial ulcer measurements, measurements at completion of at least four weeks of standard-of-care treatment, and measurements immediately before placement of the skin-substitute graft.
Member has a wound index of 1 to 25 cm².
Member has no ulcer within 3 cm of the index ulcer.
Member has an Ankle Brachial Index (ABI) level between 0.7 and 1.2.
Applicable condition-specific criteria
- For a DFU
  - Member has been assessed for Type 1 versus Type 2 diabetes and management history, with attention to comorbidities such as vascular disease, neuropathy, and osteomyelitis.
  - Member has an HbA1c level of less than 12% within 90 days of prior authorization submission.
  - Member has a serum creatinine level of less than 3.0 mg/dL.
  - Member’s diet, nutritional status, and activity level have been assessed.
  - Member’s use of an off-loading device or appropriate footwear has been assessed.
- For a VLU

Treatment Implementation and Continuation

Treatment implementation and continued applications are covered when ALL of the following requirements are met.

ALL of the following

The implemented treatment includes debridement as appropriate.
For a DFU, the implemented treatment includes a form of off-loading.
For a VLU, the implemented treatment includes a form of compression.
The implemented treatment includes infection control.
The implemented treatment includes management of exudate and maintenance of a moist environment, such as moist saline gauze, other classic dressings, or a bioactive dressing, and evaluation by an experienced wound clinician.

Skin-substitute grafts are not medically necessary for members younger than 18 years.

Skin-substitute grafts are not medically necessary when the ulcer penetrates into muscle, tendon, or bone; is located on the dorsum of the foot; or has more than 50% of its area below the malleolus.

Skin-substitute grafts are not medically necessary when the member shows signs of ulcer infection, bone infection, active Charcot arthropathy, or active vasculitis of the ulcer extremity, or has an uncontrolled infection such as bacteremia or osteomyelitis.

Skin-substitute grafts are not medically necessary when the member has received negative-pressure wound therapy or hyperbaric oxygen therapy within the last seven days, or treatment with other advanced wound-care products within the past 30 days.

Skin-substitute grafts are not medically necessary when the member is receiving immunosuppressants or corticosteroids, or is taking COX-2 inhibitors.

Skin-substitute grafts are not medically necessary when the number of applications exceeds the manufacturer’s recommended application procedures within the episode of skin-replacement surgery.

Repeat applications of skin-substitute grafts are not medically necessary when a previous application was unsuccessful. Unsuccessful treatment means the ulcer increased in size or depth, had no change in baseline size or depth, or showed no sign of improvement or indication that improvement was likely, such as granulation, epithelialization, or progress toward closing.

Skin-substitute grafts are not medically necessary when wound duration exceeds 104 weeks (two years).

MassHealth does not consider skin-substitute grafts medically necessary when the member has wounds of greater severity than Wagner II. In other words, these products are not covered for ulcers with deep bone involvement or gangrene.

Covered Products, Authorization, and Clinical Thresholds

Adult diabetic foot ulcer products not requiring prior authorizationHCPCSCovered

Q4101	Apligraf
Q4186	Epifix
Q4106	Dermagraft

Adult diabetic foot ulcer products requiring prior authorizationHCPCSCovered

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

Adult venous leg ulcer products not requiring prior authorizationHCPCSCovered

Q4186	Epifix
Q4191	Apligraf

Adult venous leg ulcer products requiring prior authorizationHCPCSCovered

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

Prior-authorization therapy duration

Authorization durationMaximum 16 weeks of therapy

Authorization periodBegins on the date of approval

Additional unitsSubmit a new prior-authorization request if additional units are needed

Application frequency

Application frequencyOne unit per week

Frequency applies toListed skin-substitute products for adult diabetic foot ulcers and venous leg ulcers

Prior Authorization and Documentation Requirements

Prior Authorization

Obtain PA for designated products

Prior authorization is required for Grafix prime or Grafixpl prime (Q4133), Amnioband (Q4151), Affinity (Q4159), and Puraply (Q4196). Authorization covers a maximum of 16 weeks of therapy at one unit per week for the listed adult diabetic foot ulcer and venous leg ulcer indications.

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

Billing Rule

Use PA-exempt products within frequency limits

Prior authorization is not required for the listed products when used at one unit per week for the specified adult ulcer indication.

Skin-Substitute Therapy Overview

Skin substitutes are cellular- and tissue-based products derived from human tissue, nonhuman sources, synthetic materials, or combinations of these sources. They replicate functional and structural features of skin and may provide temporary or permanent coverage for acute or chronic wounds, including diabetic foot ulcers, venous leg ulcers, pressure injuries, burns, and other injuries. These guidelines address listed products for adult diabetic foot ulcers and venous leg ulcers, with product selection based on wound type, etiology, tissue-replacement needs, product indications, and desired outcomes.

Key Terms

Skin substitute

Source typesHuman tissue, nonhuman tissue, synthetic materials, or combinations of these sources

Product functionReplicates the functional and structural characteristics of normal skin

Clinical useUsed as an adjunct in managing acute and chronic wounds, including diabetic foot ulcers and chronic venous ulcers

Failure to respond

Size or depthThe ulcer has increased in size or depth, or has had no change in baseline size or depth

Healing progressThe ulcer shows no sign of improvement or indication that improvement is likely

Examples of improvement

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 DateFeb 7, 2024

Next Review DateN/A

Key ActionSubmit prior authorization requests electronically through the Provider Online Service Center for products requiring authorization.

SourceLink

On This Page

Member’s clinical history, including prior ulcers and thrombosis risks, and physical examinations, including edema and skin changes, have been assessed.

Member has had diagnostic testing to verify superficial or deep venous reflux, perforator incompetence, and chronic or acute venous thrombosis, or has evidence of varicosities, lipodermatosclerosis, venous dermatitis, or other clinical signs of a VLU.

Member’s standard-of-care treatment has continued for no less than four weeks and includes ongoing compression therapy.

Member’s smoking history is documented and the member has received counseling on smoking’s effect on surgical outcomes and treatment for smoking cessation.

The member must be a nonsmoker, or must have refrained from smoking for at least six weeks before treatment, or must be undergoing treatment for smoking cessation.

Member is able to follow the treatment plan.

The ulcer improves significantly over six weeks of treatment with skin substitutes; continued significant improvement every six weeks is required for coverage of ongoing applications.

If the member is pregnant, informed consent is provided because these products have largely not been tested in this population.

Additional unitsA new prior-authorization request is required if additional units are needed

Standard-of-care duration

Minimum durationAt least four weeks

Defined periodFour weeks is defined as 30 days

DocumentationDocument compliance with prescribed treatment and ulcer measurements before and after standard-of-care treatment

Member age

Minimum age18 years

EligibilityThe member must be 18 years of age or older

Noncoverage thresholdMembers younger than 18 years are not eligible under the guideline

Wound index

Wound index area1 to 25 cm²

Additional ulcer requirementThere must be no ulcer within 3 cm of the index ulcer

ApplicabilityThe wound-index requirement applies to chronic diabetic foot ulcers and venous leg ulcers

Ankle Brachial Index

Required ABI rangeBetween 0.7 and 1.2

AssessmentAn Ankle Brachial Index level must be documented

ApplicabilityThe ABI requirement applies to the shared clinical coverage criteria

HbA1c for diabetic foot ulcers

HbA1c thresholdLess than 12%

TimingResult must be within 90 days of prior-authorization submission

ApplicabilityRequired for members with diabetic foot ulcers

Serum creatinine for diabetic foot ulcers

Serum creatinine thresholdLess than 3.0 mg/dL

ApplicabilityRequired for members with diabetic foot ulcers

Related assessmentDiabetes type, management history, and relevant comorbidities must also be assessed

Continuation response

Initial responseThe ulcer must improve significantly over six weeks of skin-substitute treatment

Ongoing responseSignificant improvement is required during every subsequent six-week period

Coverage impactOngoing applications require continued significant improvement

Recent negative-pressure or hyperbaric therapy

Negative-pressure therapyMust not have been received within the last 7 days

Hyperbaric oxygen therapyMust not have been received within the last 7 days

Coverage implicationRecent receipt of either therapy is a noncoverage circumstance

Recent advanced wound-care products

Advanced wound-care productsMust not have been used within the past 30 days

Covered timingThe 30-day period is measured before the requested skin-substitute treatment

Coverage implicationUse of another advanced wound-care product within 30 days is a noncoverage circumstance

Maximum wound duration

Maximum wound duration104 weeks

Equivalent duration2 years

Coverage implicationWounds beyond 104 weeks or 2 years are not covered under the guideline

Apligraf (Q4101): adult diabetic foot ulcers
Epifix (Q4186): adult diabetic foot ulcers or venous leg ulcers
Dermagraft (Q4106): adult diabetic foot ulcers
Apligraf (Q4191): adult venous leg ulcers

Prior Authorization

Submit PA through the correct channel

For products requiring authorization, the MassHealth-enrolled surgeon performing the procedure must submit the clinical information and supporting documentation electronically through the Provider Online Service Center. Providers with an approved electronic claims waiver must submit the PA-1 Form with all supporting documentation.

Submit documentation demonstrating that the member meets the clinical coverage criteria.
Include the medical-history summary, recent clinical evaluations, and wound documentation required by the guideline.

Step Therapy

Document the required standard-of-care trial

Before skin-substitute placement, the chronic noninfected diabetic foot ulcer or venous leg ulcer must fail to respond to at least four weeks, defined as 30 days, of documented standard-of-care treatment with documented compliance.

Include applicable debridement and infection control.
Use off-loading for diabetic foot ulcers and compression for venous leg ulcers.
Manage exudate while maintaining a moist environment and document evaluation by an experienced wound clinician.

Step Therapy

Continue compression for VLUs

For venous leg ulcers, standard-of-care treatment must continue for no less than four weeks and include ongoing compression therapy.

Document the duration of compression therapy.
Continue compression as part of treatment for ongoing applications.

Documentation Required

Include the medical history and treatment plan

The MassHealth-enrolled surgeon performing the procedure must submit a medical-history summary identifying the primary diagnosis and condition-specific HCPCS code, diagnosis date, past treatment course, and current plan of care.

Primary diagnosis name and HCPCS code specific to the condition requiring the procedure
Date of diagnosis
Past treatment course
Current plan of care

Documentation Required

Provide a recent clinical evaluation

Submit relevant diagnostic studies and laboratory results from the last year, the member’s prescription and over-the-counter medication regimen from the last three to six months, current medical and functional risk factors, surgeries and procedures, and past and present substance misuse.

Include relevant test and study results conducted within the last year.
Describe current medical or comorbid conditions and functional status.
Report substance misuse history, including the date or period since last use.

Documentation Required

Document smoking status and noncoverage factors

Document tobacco use, smoking-cessation counseling and efforts, and testing for abstinence when clinically indicated. Also document any applicable noncoverage circumstances listed in Section II.B.

Record smoking history and counseling on smoking’s effects on surgical outcomes and treatment.
Document cessation efforts and abstinence testing when clinically indicated.
Document relevant substance-use history and other applicable noncoverage factors.

Documentation Required

Submit serial wound photographs

Provide clinical photographs with wound measurements for each subsequent submission, including prior photographs.

Include photographs for every subsequent submission.
Include wound measurements with the photographs.
Retain and submit prior photographs.

Documentation Required

Record serial measurements and clinical criteria

Document initial ulcer measurements, measurements after at least four weeks of standard-of-care treatment, and measurements immediately before graft placement. Also document compliance with prescribed treatment and the required wound, vascular, disease-specific, and treatment assessments.

Record the initial ulcer measurements.
Record measurements at completion of at least four weeks of standard-of-care treatment.
Record measurements immediately before skin-substitute placement.
Document ABI and applicable diabetic foot ulcer or venous leg ulcer assessments.

Denial Risk

Screen for severe, infected, or ineligible wounds

Coverage may be denied when the member is younger than 18 or the ulcer penetrates muscle, tendon, or bone. Denial risks also include ulcer infection, bone infection, active Charcot arthropathy, active vasculitis, uncontrolled infection such as bacteremia or osteomyelitis, deep bone involvement, or gangrene.

Confirm the member is at least 18 years old.
Confirm the ulcer is not infected and does not involve muscle, tendon, or bone.
Confirm the wound is not more severe than Wagner II.

Denial Risk

Check location, severity, and duration exclusions

Coverage may be denied for an ulcer on the dorsum of the foot, more than 50% of the ulcer below the malleolus, a wound more severe than Wagner II, or wound duration beyond 104 weeks or two years.

Verify ulcer location and the proportion below the malleolus.
Confirm wound duration does not exceed 104 weeks or two years.
Confirm the wound does not have deep bone involvement or gangrene.

Denial Risk

Review recent therapies and medications

Coverage may be denied when negative-pressure wound therapy or hyperbaric oxygen therapy was received within the last seven days, another advanced wound-care product was used within the last 30 days, or the member is receiving immunosuppressants or corticosteroids or taking COX-2 inhibitors.

Check for negative-pressure wound therapy or hyperbaric oxygen therapy in the prior seven days.
Check for other advanced wound-care products in the prior 30 days.
Review current immunosuppressants, corticosteroids, and COX-2 inhibitors.

Denial Risk

Avoid excessive or unsuccessful repeat applications

Repeat applications may be denied when the manufacturer-recommended number of procedures has been exceeded or a prior skin-substitute application was unsuccessful. Unsuccessful treatment means the ulcer increased in size or depth, remained unchanged from baseline, and showed no sign of improvement or likely improvement.

Do not exceed the manufacturer’s recommended application procedures during the episode of skin-replacement surgery.
Document the outcome of prior applications before requesting a repeat graft.

Denial Risk

Demonstrate improvement for continuation therapy

Ongoing applications require significant ulcer improvement over six weeks of skin-substitute treatment and continued significant improvement during each subsequent six-week period.

Document the ulcer’s response over each six-week interval.
Support each continued application with evidence of significant improvement.

Granulation, epithelialization, or progress toward closing indicate potential improvement

Unsuccessful treatment

Size or depthThe ulcer increased in size or depth, or had no change in baseline size or depth

Healing progressThe ulcer showed no sign of improvement or indication that improvement is likely

Examples of improvementGranulation, epithelialization, or progress toward closing indicate potential improvement