MIR-2006-7A, July 2006

Local Coverage Determinations (LCD) Summary

Providers: If you wish to obtain the full text of the LCDs (and articles) described in this section, they are available on the Empire Medicare Services Web site at: http://www.empiremedicare.com/PartA/parta_lcd.cfm.

Read and accept the CPT License for Use, then click on the “Policies in Notice Period” link, or write to:

Empire Medicare Services
P.O. Box 4846
Syracuse, NY 13221-4846
Attention: Coordination Department

Or call the Empire Medicare Services Provider Inquiries Department at 1-888-855-4356.

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Click on the appropriate “subscribe to mailing list” link and fill in the requested information.

Local Coverage Determination

The Local Coverage Determination (LCD) Title: Human Skin Equivalent

Medicare Coverage Database Contractor’s Determination Number: L22620

Notice Period: June 7, 2006 through July 21, 2006

Effective Date: July 22, 2006

LCD Description:
Dermal-epidermal tissue (DET) substitute (e.g., Apilgraf®) is a bi-layered skin product approved for use in the treatment of noninfected partial and full-thickness skin ulcers due to venous insufficiency, i.e., venous stasis ulcers (VSU) and full-thickness neuropathic diabetic foot ulcers (DFU). DET is manufactured from a living neonatal male foreskin and it consists of two (2) primary layers; the epidermal layer is formed by human keratinocytes and has a well-differentiated stratum corneum; the dermal layer is composed of human fibroblasts in a bovine Type I collagen lattice.

Dermal tissue (DT) substitute (e.g., Dermagraft®) is a single layered skin product derived from cryo-preserved human fibroblast. DT is also manufactured from a living newborn male foreskin and is composed of fibroblasts, extra-cellular matrix, and a bioabsorbable scaffold. It is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than six (6)-weeks duration which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure.

A partial-thickness skin ulcer is one in which the wound base is visible and the ulcer does not extend through the dermis. A full-thickness skin ulcer is one in which the base is visible and the ulcer extends through the dermis but not into the subcutaneous tissue to fascia, muscle, or bone.

For the purpose of this policy, reapplication is referring to an additional application of skin substitutes to the same ulcer within the same treatment period. Retreatment is referencing a new treatment period where the same ulcer is being treated again because the initial treatment has most likely failed.

This policy sets forth the criteria for coverage and instructions for claim submission for both dermal-epidermal tissue (DET) and dermal tissue (DT) skin substitutes. The brand named products, Apligraf® and Dermagraft®, are examples of these tissue substitutes, but this policy will apply to any Food and Drug Administration (FDA)-approved skin substitute products meeting the criteria of this policy.