Coverage Guidance


Coverage Indications, Limitations, and/or Medical Necessity

The provisions of this LCD apply to payment for bioengineered skin substitutes (BSS) for chronic ulcers of the lower extremities secondary to diabetes and venous stasis. This LCD does not address human skin autografts, cadaveric human skin allografts, or dermal xenografts (porcine). Additionally, the provisions of this LCD do not apply to treatment of acute wounds, tendon and/or ligament augmentation/repair, postoperative wounds, burns or pressure ulcers.

Indications

Applied to partial- or full-thickness ulcers of the lower extremities (see individual product information for labeled indications) as adjunctive therapy only after failing treatment with standard wound therapy. Failure to respond to standard wound therapy occurs when there are no documented measurable signs of healing for at least 30 consecutive days. Standard wound therapy includes:

assessment of a patient’s vascular status (e.g. presence of acceptable: lower extremity pulses, Doppler toe signals, Ankle-Brachial Index; evaluation of venous insufficiency; evaluation of edema) and correction of any vascular problems in the affected limb if possible;
optimization of nutritional status;
optimization of glucose control (when applicable);
debridement by any means to remove devitalized tissue;
maintenance of a clean, moist bed of granulation tissue with appropriate moist dressings;
appropriate off-loading; and
necessary treatment to resolve any infection that might be present.

Limitations

During an initial course of treatment, repeat applications of skin substitutes/replacements are not indicated when applications were unsuccessful.

Initiation of retreatment of healed ulcers that have recurred is not indicated.

Coverage will not be provided under this LCD for any ulcer treatment of the lower extremities that does not meet the definition of Q4101, Q4102, Q4106, Q4107, Q4121, Q4127, Q4131, Q4132, Q4133 or Q4158 . Other products of the skin substitute series (Q4100-Q4111, Q4115-Q4120, Q4122-Q4126, Q4128-Q4130, Q4134-Q4138, Q4140-Q4143, Q4146-Q4148, Q4151- Q4161, Q4163-Q4165 and C9363) will be considered to be “biologic wound dressings” which are part of the relevant service provided and not separately payable.

The following modifiers were effective for dates of service on or after 01/01/2009:

JC – Skin substitute used as a graft
JD – Skin substitute not used as a graft

Providers should use the above modifiers in compliance with CPT ® and CMS instructions.

The following indications and limitations to Medicare coverage and payment apply to the specified BSS and their related skin substitute application physician services.

Apligraf ® (Q4101) is approved for diabetic foot ulcer and venous stasis ulcer. Additionally, diabetic ulcers of the ankle and calf are covered. Medicare payment for Apligraf ® is limited to five applications per ulcer.

Oasis ® (Q4102) is approved for diabetic foot ulcer and venous stasis ulcer. Additionally, diabetic ulcers of the ankle and calf are covered. Medicare payment for Oasis ® is limited to 12 weeks of therapy per ulcer.

Dermagraft ® (Q4106) is approved for treatment of full-thickness diabetic foot ulcers. Additionally, diabetic ulcers of the ankle and calf are covered. Frequency is limited to eight applications per ulcer. Medicare does not cover continued reapplication of Dermagraft ® for the same ulcer if satisfactory and reasonable healing progress is not noted after 12 weeks of therapy.

GraftJacket ® (Q4107) is approved for full-thickness diabetic foot ulcers. Additionally, diabetic ulcers of the ankle and calf are covered. Medicare payment for GraftJacket ® is limited to 1 application per ulcer.

TheraSkin® (Q4121) is approved for diabetic foot ulcer and venous stasis ulcer. Additionally, diabetic ulcers of the ankle and calf are covered. Medicare payment for TheraSkin® is limited to five applications per ulcer.

Talymed ® (Q4127) is approved for diabetic foot ulcer and venous stasis ulcer. Additionally, diabetic ulcers of the ankle and calf are covered. Medicare payment for Talymed ® is limited to five applications per ulcer.

Epifix ® (Q4131) is approved for diabetic foot ulcer and venous stasis ulcer. Additionally, diabetic ulcers of the ankle and calf are covered. Medicare payment for Epifix ® is limited to five applications per ulcer.

Grafix® (Q4132 and Q4133) is a covered therapeutic option for the treatment of diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) (but not limited to these). Medicare payment for Grafix® is limited to five applications per ulcer.

Kerecis Omega3 Wound® (Q4158) is approved for diabetic foot ulcer and venous stasis ulcer. Additionally, diabetic ulcers of the ankle and calf are covered. Medicare payment for Kerecis Omega3 Wound® is limited to twelve applications per ulcer.

Surgical Wound Preparation (CPT ® codes 15002–15005)
Medicare does not expect to be billed for CPT ® codes 15002–15005 in conjunction with routine, simple and/or repeat application of skin substitutes/replacements.

Skin Substitute Application Procedures (CPT ® codes 1527X)
BSS application codes should meet the definition of the CPT ®/HCPCS code descriptor.

Product Wastage

Medicare provides payment for the amount of the BSS product that is reasonable and necessary to treat the patient’s ulcer. If the physician has made good faith efforts to minimize the unused portion of the BSS product in how patients are scheduled and how he/she ordered, accepted, stored and used the product, and made good faith efforts to minimize the unused portion of the product in how it is supplied, the program will cover the amount of product discarded along with the amount used to treat the ulcer. Documentation requirements for unused/discarded materials are provided in coverage in interpretive manuals: Internet Only Manual (IOM): Medicare Claims Processing Manual – Pub. 100-04, Chapter 17, Section 40.

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the policy, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

CPT/HCPCS Codes

Group 1 Codes:
Q4101 Apligraf
Q4102 Oasis wound matrix
Q4121 Theraskin
Q4127 Talymed
Q4131 Epifix or epicord
Q4132 Grafix core
Q4133 Grafix prime
Q4106 Dermagraft
Q4107 Graftjacket

Group 3 Paragraph: Not Separately Payable

Group 3 Codes:

C9363 Integra meshed bil wound mat

Q4100 Skin substitute, nos

Q4103 – Q4105 Oasis burn matrix – Integra drt or omnigraft

Q4108 – Q4111 Integra matrix – Gammagraft

Q4115 – Q4118 Alloskin – Matristem micromatrix

Q4122 – Q4126 Dermacell – Memoderm/derma/tranz/integup

Q4128 – Q4130 Flexhd/allopatchhd/matrixhd – Strattice tm

Q4134 – Q4138 Hmatrix – Biodfence dryflex, 1cm

Q4140 – Q4143 Biodfence 1cm – Repriza, 1cm

Q4146 – Q4148 Tensix, 1cm – Neox 1k, 1cm

Q4151 – Q4161 Amnioband, guardian 1 sq cm – Bio-connekt per square cm

Q4163 – Q4165 Amnio bio and woundex sq cm – Keramatrix, per square cm

ICD-10 Codes that Support Medical Necessity

Group 1 Paragraph: The correct use of an ICD-10-CM code listed in the “ICD-10 Codes that Support Medical Necessity” section does not guarantee coverage of a service. The service must be reasonable and necessary in the specific case and must meet the criteria specified in this LCD.

ICD-10 codes must be coded to the highest level of specificity. Consult the ‘Official ICD-10-CM Guidelines for Coding and Reporting’ in the current ICD-10-CM book for correct coding guidelines. This LCD does not take precedence over the Correct Coding Initiative (CCI).

The recommended ICD-10 codes applicable to the indications in the LCD are as follows:

Q4101 used to report Apligraf®, Q4102 used to report Oasis®, Q4121 used to report Theraskin, Q4127 used to report Talymed®, Q4131 used to report Epifix® and Q4132 and Q4133 used to report Grafix®:

ICD-10 CODE DESCRIPTION

E10.621 – E10.622 – Opens in a new window Type 1 diabetes mellitus with foot ulcer – Type 1 diabetes mellitus with other skin ulcer

E11.621 – E11.622 – Opens in a new window Type 2 diabetes mellitus with foot ulcer – Type 2 diabetes mellitus with other skin ulcer

E13.621 – E13.622 – Opens in a new window Other specified diabetes mellitus with foot ulcer – Other specified diabetes mellitus with other skin ulcer

I83.002 – I83.008 – Opens in a new window Varicose veins of unspecified lower extremity with ulcer of calf – Varicose veins of unspecified lower extremity with ulcer other part of lower leg

I83.012 – I83.018 – Opens in a new window Varicose veins of right lower extremity with ulcer of calf – Varicose veins of right lower extremity with ulcer other part of lower leg

I83.022 – I83.028 – Opens in a new window Varicose veins of left lower extremity with ulcer of calf – Varicose veins of left lower extremity with ulcer other part of lower leg

I83.202 – I83.208 – Opens in a new window Varicose veins of unspecified lower extremity with both ulcer of calf and inflammation – Varicose veins of unspecified lower extremity with both ulcer of other part of lower extremity and inflammation

I83.212 – I83.218 – Opens in a new window Varicose veins of right lower extremity with both ulcer of calf and inflammation – Varicose veins of right lower extremity with both ulcer of other part of lower extremity and inflammation

I83.222 – I83.228 – Opens in a new window Varicose veins of left lower extremity with both ulcer of calf and inflammation – Varicose veins of left lower extremity with both ulcer of other part of lower extremity and inflammation

I87.311 – I87.313 – Opens in a new window Chronic venous hypertension (idiopathic) with ulcer of right lower extremity – Chronic venous hypertension (idiopathic) with ulcer of bilateral lower extremity

I87.331 – I87.333 – Opens in a new window Chronic venous hypertension (idiopathic) with ulcer and inflammation of right lower extremity – Chronic venous hypertension (idiopathic) with ulcer and inflammation of bilateral lower extremity

ICD-10 CODE DESCRIPTION

E10.621 – E10.622 – Opens in a new window Type 1 diabetes mellitus with foot ulcer – Type 1 diabetes mellitus with other skin ulcer
E11.621 – E11.622 – Opens in a new window Type 2 diabetes mellitus with foot ulcer – Type 2 diabetes mellitus with other skin ulcer
E13.621 – E13.622 – Opens in a new window Other specified diabetes mellitus with foot ulcer – Other specified diabetes mellitus with other skin ulcer
Showing 1 to 3 of 3 entries in Group 2
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