Local Coverage Determination (LCD): Surgery: Bioengineered ...

Local Coverage Determination (LCD):
Surgery: Bioengineered Skin Substitutes (BSS) for the
Treatment of Diabetic and Venous Stasis Ulcers of the Lower
Extremities (L31428)

Contractor Name
Cahaba Government Benefit
Administrators®, LLC

LCD Information

Document Information

LCD ID
L31428

LCD Title Original Effective Date
Surgery: Bioengineered Skin Substitutes (BSS) for For services performed on or after 04/01/2011
the Treatment of Diabetic and Venous Stasis Ulcers
of the Lower Extremities Revision Effective Date
For services performed on or after 01/01/2014
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recommending their use. The AMA does not directly 02/14/2011
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CMS National Coverage Policy
 Title XVIII of the Social Security Act, Section 1833 (e). This section prohibits Medicare payment for any claim

that lacks the necessary information to process the claim.
 Title XVIII of the Social Security Act, Section(s) 1861(s) and (t). These sections outline coverage for drugs and

biologicals and services and supplies.
 Title XVIII of the Social Security Act, Section 1862 (a)(1)(A). This section allows coverage and payment for only

those services that are considered to be medically reasonable and necessary.
 Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.
 Medicare Benefit Policy Manual (Pub.100-02), Chapter 15, Section 50 and Section 100.
 Medicare Claims Processing Manual (Pub. 100-04), Chapter 17, Section 20 and Section 40.
 Medicare Program Integrity Manual (Pub. 100-08), Chapter 13, Local Coverage Determinations.

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

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

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

3. 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, or Q4131. Other products of the skin substitute
series (Q4100 through Q4111, Q4115-Q4130, Q4132-Q4138, Q4140-Q4143, Q4146-Q4148, 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:

A. JC – Skin substitute used as a graft
B. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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

10. 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.

Coding Information

Bill Type Codes:
Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this
service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete
absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be
assumed to apply equally to all claims.
N/A

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.

N/A

CPT/HCPCS Codes

Group 1 Paragraph: N/A

Group 1 Codes:

Q4101 Apligraf
Q4102 Oasis wound matrix
Q4106 Dermagraft
Q4107 Graftjacket
Q4131 Epifix
Group 2 Paragraph: Not Separately Payable

Group 2 Codes:

C9363 Integra Meshed Bil Wound Mat

Q4100 Skin substitute, NOS

Q4103 - Q4105 Oasis burn matrix - Integra DRT

Q4108 - Q4111 Integra matrix - Gammagraft

Q4115 - Q4130 Alloskin - Strattice TM

Q4132 - Q4138 Grafix core - BioDfence dryflex, 1cm

Q4140 - Q4143 Biodfence 1cm - Repriza, 1cm

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

Group 3 Paragraph: Other CPT/HCPCS Codes addressed in this LCD

Group 3 Codes:

15002 - 15005 Wound prep trk/arm/leg - Wnd prep f/n/hf/g addl cm
15271 - 15278 Skin sub graft trnk/arm/leg - Skn sub grft f/n/hf/g ch add

ICD-9 Codes that Support Medical Necessity

Group 1 Paragraph: The correct use of an ICD-9-CM code listed in the "ICD-9 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-9 codes must be coded to the highest level of specificity. Consult the ‘Official ICD-9-CM Guidelines for
Coding and Reporting’ in the current ICD-9-CM book for correct coding guidelines. This LCD does not take

precedence over the Correct Coding Initiative (CCI).

The recommended ICD-9 codes applicable to the indications in the LCD are as follows:
Q4101 used to report Apligraf®, Q4102 used to report Oasis®, and Q4131 used to report Epifix®:

Group 1 Codes:

250.80 - DIABETES WITH OTHER SPECIFIED MANIFESTATIONS, TYPE II OR UNSPECIFIED TYPE, NOT
250.83 STATED AS UNCONTROLLED - DIABETES WITH OTHER SPECIFIED MANIFESTATIONS, TYPE
I [JUVENILE TYPE], UNCONTROLLED

454.0 VARICOSE VEINS OF LOWER EXTREMITIES WITH ULCER

454.2 VARICOSE VEINS OF LOWER EXTREMITIES WITH ULCER AND INFLAMMATION

459.31 CHRONIC VENOUS HYPERTENSION WITH ULCER

459.33 CHRONIC VENOUS HYPERTENSION WITH ULCER AND INFLAMMATION

707.12 -
ULCER OF CALF - ULCER OF OTHER PART OF FOOT

707.15

Group 2 Paragraph: Q4106 used to report Dermagraft® and Q4107 used to report GraftJacket®

Group 2 Codes:

250.80 - DIABETES WITH OTHER SPECIFIED MANIFESTATIONS, TYPE II OR UNSPECIFIED TYPE, NOT
250.83 STATED AS UNCONTROLLED - DIABETES WITH OTHER SPECIFIED MANIFESTATIONS, TYPE
I [JUVENILE TYPE], UNCONTROLLED

707.12 -
ULCER OF CALF - ULCER OF OTHER PART OF FOOT

707.15

ICD-9 Codes that DO NOT Support Medical Necessity
Paragraph: N/A

Codes:
XX000* Not Applicable

General Information

Associated Information

Documentation Requirements

1. This LCD supports the electronic health record (EHR) initiative. The initial application of the BSS should be
documented in the medical record with at least one color photograph.

2. The exact location and measurments (depth, width, and length or diameter) of each ulcer treated must be
included in the medical record per visit.

3. The record must document failure of standard wound therapy, as noted in the ‘Indications’.

4. All ‘Indications’ must be clearly documented in the patient’s medical record and made available to Medicare
upon request.

5. Documentation must support CMS 'signature requirements' as described in the Medicare Program Integrity
Manual (Pub. 100-08), Chapter 3.

Utilization Guidelines

1. Medicare expects skin substitutes/replacements to be applied according to the manufacturers’ instructions
listed below:

A. Up to five applications of Apligraf® (Q4101) per ulcer.

B. Up to twelve applications of Oasis® (Q4102) per ulcer.

C. Up to eight applications of Dermagraft® (Q4106) per ulcer.

D. One application of GraftJacket® (Q4107) per ulcer.

E. Up to five applications of Epifix® (Q4131) per ulcer.

Any utilization above these parameters is subject to medical review.

2. A pink, viable, fenestrated BSS can be debrided peripherally and left in place. Medicare would not expect
removal and reapplication more frequently than every ten days. Exceptions with more frequent timing
(every seven days) should be documented with appropriate narrative.

Sources of Information and Basis for Decision
 Consultation with the Carrier Advisory Committee and other Medicare contractors
 Karr, Jeffrey C., DPM. “Retrospective Comparison of Diabetic Foot Ulcer and Venous Stasis Ulcer Healing

Outcome Between a Dermal Repair Scaffold (PriMatrix™) and a Bi-layered Living Cell Therapy (Apligraf®),
Accepted for publication in Advances in Skin & Wound Care: 2011

 Mostow, Eliot N., et al. “Effectiveness of an extracellular matrix graft (OASIS Wound Matrix) in the

treatment of chronic leg ulcers: A randomized clinical trial”, Journal of Vascular Surgery. May 2005: Volume
41: Number 5: 837-843.

 Niezgoda, Jeffrey A., et al. “Randomized Clinical Trial Comparing OASIS Wound Matrix to Regranex Gel for

Diabetic Ulcers”, Advances in Skin & Wound Care: June 2005: Volume 18: Number 5: 258-266.

 Other Medicare Contractor’s Local Coverage Determinations
 Prescribing Information: Apligraf®, Organogenesis, Inc.
 Prescribing Information: Dermagraft®, Advanced Biohealing, Inc.
 Prescribing Information: GraftJacket®, Wright Medical Technology, Inc.
 Prescribing Information: Oasis®, Healthpoint, Ltd.
 Product Information: Epifix®, MiMedx Group, Inc. Available at: www.mimedx.com
 Reyzelman, A., et al. “Clinical effectiveness of an acellular dermal regenerative tissue matrix compared to

standard wound management in healing diabetic foot ulcers: a prospective, randomised, multicentre study,”
(Abstract). International Wound Journal: June 2009: Volume 6: Number 3: 196-208.

 Waugh, Helen V, PhD., Sherrat, Jonathan A, PhD. “Modeling the effects of treating diabetic wounds with

engineered skin substitutes”. Wound Repair and Regeneration: 2007: Vol. 15: 556-565.

 Zaulyanov, Larissa, Kirsner Robert S. “A review of a bi-layered living cell treatment (Apligraf ®) in the

treatment of venous leg ulcers and diabetic foot ulcers”. Clinical Interventions in Aging: 2007:2 (1):93-98.

Revision History Information

Please note: The Revision History information included in this LCD prior to 1/24/2013 will now
display with a Revision History Number of "R1" at the bottom of this table. All new Revision
History information entries completed on or after 1/24/2013 will display as a row in the Revision
History section of the LCD and numbering will begin with "R2".

Revision Revision

History History Revision History Explanation Reason(s) for Change

Date Number

01/01/2014 R4 What’s New Posted: December 2013  Revisions Due To

Effective Date: January 1, 2014 CPT/HCPCS Code

Changes

1. This LCD was updated as a result of the Annual

CPT/HCPCS Update for 2014. These code revisions reflect

services which are currently addressed in the LCDs and do

not establish any new indications within nor restrict the

current coverage. The following revisions were made:

o C9367 is invalid and was removed from the LCD.
o Q4137, Q4138, Q4140-Q4143, Q4146-Q4148 are being

added to the list of HCPCS codes that are ‘Not Separately
Payable’.

2. The range of products in Limitation #3 considered to be
‘biologic wound dressings’ was corrected to remove Q4131.

01/01/2014 R3 What’s New Posted: December 2013  Other (Clarification of
Effective Date: January 1, 2014 LCD)

This LCD was revised to further clarify that: 1) The
provisions of the LCD apply to payment for bioengineered
skin substitutes (BSS) for chronic ulcers of the lower
extremities secondary to diabetes and venous stasis, and 2)

the provisions of this LCD do not apply to pressure ulcers.

01/01/2013 R2 The 'Indications' section was re-formatted for clarity.  Reconsideration
What’s New Posted: February 2013 Request
Effective Date: January 1, 2013

Epifix (Q4131) is being removed from the list of HCPCS
codes ‘Not Separately Payable’ and is being added to the

CPT/HCPCS codes covered as a skin substitute for the

purposes of this LCD.

(Added CPT Codes 15002-15005, 15271-15278 to

CPT/HCPCS field for tracking)

01/01/2013 R1 Revision 4  HCPCS

What’s New Posted: December 2012 Addition/Deletion
 HCPCS/ICD9 Descriptor

Effective Date: January 1, 2013 Change

This LCD was updated as a result of the Annual
CPT/HCPCS Update for 2013. These code revisions reflect
services which are currently addressed in the LCDs and do
not establish any new indications within nor restrict the
current coverage. The following revision was made:

 Q4131 – Q4136 are being added to the list of HCPCS codes
that are ‘Not Separately Payable’.
Revision 3

What's New Posted Date: December 2011
Effective Date: January 1, 2012

This LCD is being updated as a result of the Annual
CPT/HCPCS Update for 2012. The code revisions reflect
services which are currently addressed in this LCD and do
not establish any new indications within nor restrict the
current coverage.

 Skin substitute application codes 153XX and G044X are
invalid after December 31, 2011 and are replaced with
1527X.

 Q4122 – Q4130 are being added to the list of CPT/HCPCS
codes that are not separately payable.
Revision 2

October 28, 2011:

Updated ‘Documentation Requirements' to standardize
LCDs:
1. Documentation Requirement regarding legibility and access
to records was modified.
2. The reference to the Medicare Program Integrity Manual
(Pub. 100-08)was updated. (Change Request 6560).
No change in effective date or coverage.

NOTE: 10/13/2011 - MCD Article for LCD Comments
attached to LCD.

Revision 1

What's New Posted Date: March 2011
Effective Date: April 1, 2011

The final draft LCD was effective April 1, 2011 following a
forty-five day Notice Period.

Effective April 1, 2011, the LCD is being liberalized with the
following update:

The indications for Apligraf® (Q4101), Oasis® (Q4102),
Dermagraft ® (Q4106) and GraftJacket ® (Q4107) are being
expanded to include coverage of diabetic ulcers of the ankle
and calf. ICD-9 codes 707.12 and 707.13 are currently

included in the list of ‘ICD-9 Codes that Support Medical
Necessity’ for these products.

In addition, the ‘Indications’ section is being updated to
provide further clarification of standard wound evaluation
and therapy.

Template language in 'ICD-9 Codes that Support Medical
Necessity' clarified regarding correct coding guidelines.

What's New Posted Date: February 2011
Newsline Posted Date: February 2011
Notice Period: February 14, 2011 - March 31, 2011
Effective Date: April 1, 2011

This new LCD provides coverage guidance for HCPCS
codes Q4101, Q4102, Q4106 and Q4107.

11/21/2010 - For the following CPT/HCPCS codes either the
short description and/or the long description was changed.
Depending on which description is used in this LCD, there
may not be any change in how the code displays in the
document:
Q4101, Q4102, Q4106, Q4107 descriptor was changed in
Group 1
Q4103, Q4104, Q4105, Q4108, Q4110, Q4111, Q4115,
Q4116 descriptor was changed in Group 2

The following CPT/HCPCS codes were deleted: Q4109 was
deleted from Group 2

11/25/2012 - For the following CPT/HCPCS codes either the
short description and/or the long description was changed.
Depending on which description is used in this LCD, there
may not be any change in how the code displays in the

document:

Q4119 descriptor was changed in Group 2

Q4126 descriptor was changed in Group 2

Q4128 descriptor was changed in Group 2

(LCD approved 12/06/2012 for this update)

Associated Documents

Attachments
N/A
Related Local Coverage Documents
Article(s)
A50634 - (MCD Archive Site)
Related National Coverage Documents
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Public Version(s)
Updated on 12/31/2013 with effective dates 01/01/2014 - N/A
Updated on 12/06/2013 with effective dates 01/01/2014 - N/A
Updated on 02/08/2013 with effective dates 01/01/2013 - 12/31/2013
Updated on 12/06/2012 with effective dates 01/01/2013 - N/A
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.