DRUG AGENDA - May 2015

Helicoll

Second request to establish a new Level II HCPCS code to identify a bovine collagen acellular dermal matrix,Trade Name: Helicoll™. Applicant's suggested language: Q41XX -Helicoll™ Accellular Dermal Matrix, per square centimeter.


Background/Discussion:
    EnColl Corporation requests a HCPCS code to identify Helicoll, a bovine collagen acellular dermal matrix. Helicoll is a semi-occlusive, self-adhering and sterilized Type-1 collagen sheet for wound treatments, second degree burns, and chronic ulcers.

 It is indicated for use as a topical collagen wound dressing, and topical wound management including partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears, and for surgical wounds, donor sites/grafts, post-Mohs’ surgery, post-laser surgery, podiatric, wound dehiscence).  Biodegradable collagen dressings are derived from animal tissues; they maintain a moist environment that promotes healing and the formation of granulation tissue. Helicoll is individually packaged and intended as a single application for an individual patient. Product should be trimmed to size prior to contact with the patient. It is supplied in a multiple sizes ranging from 2x2 to 6x26 square inches.

The requester comments that prior assignment to codes A6021 and A6023 are inadequate to describe Helicoll, because Encoll revised its description of the product to refer to it as a Bioengineered Acellular Construct, or a Biological Skin Substitute, or as an Acellular Dermal Replacement Matrix, and “the product is not used anymore as a collagen dressing, but as a bioengineered skin substitute,” and is more appropriately coded in the Q41XX code series. 

Preliminary Decision:
   Use existing A6021 "Collagen dressing, sterile, size 16 sq. in. or less, each"; A6022 "Collagen
dressing, sterile, size more than 16 sq. in. but less than or equal to 48 sq. in., each"; or A6023
"Collagen dressing, sterile, size more than 48 sq. in., each,”  based on size,adequately describes the product that is the subject of this request. 

Keramatrix

Request to establish a unique Level II HCPCS Q-code to identify a matrix skin substitute,
Trade Name:  Keramatrix®.  Applicant's suggested language: Q41xx -keramatrix®, per square
centimeter.


Background/Discussion:
   Keraplast Technologies, LLC, submitted a request for a HCPCS code to identify Keramatrix, an open-cell wound dressing comprised of freeze-dried acellular, animal-derived keratin protein.  Keramatrix provides a biocompatible cell-growth substrate or scaffold for growth of new tissue
in three dimensions and is resorbed into the developing tissue.  When a wound occurs, the epithelium
is lost and thus the keratin based skin structure is also lost; keramatrix substitutes the outer layer of the skin by introducing a replacement keratin-based structure. When placed in the wound bed it provides a cell-growth-friendly structure for tissue regeneration and maintains moist wound healing environment.

Through interaction with enzymes in the healing wound, keramatrix is degraded to a gel which is resorbed. Keramatrix is indicated for the patient population with the following types of chronic wounds: pressure ulcers, venous stasis ulcers, ulcers caused by mixed vascular etiologies, diabetic ulcers and donor sites and grafts. It is supplied in various sizes. 

The requester claims a significant therapeutic distinction between Keramatrix and “Standard Care”
wound products, based on Keramatrix’ combination of moist wound healing, growth-friendly structure and resorption into the wound,causing minimal disturbance to developing tissue. 

The requester comments that, because HCPCS identifiers for skin substitutes are brand-specific,
existing codes do not adequately describe Keramatrix. 

Preliminary Decision:
  Establish QXXXX, Keramatrix, per square centimeter.

Integra

Repeat request to establish a unique Level II HCPCS code to identify INTEGRA®Meshed Bilayer Wound Matrix.  Applicant's suggested language: Integra Meshed Bilayer Wound Matrix, per sq cm.

Background/Discussion:
     Integra LifeSciences Corporation submitted a request  to establish a new permanent code to
identify Integra Meshed Bilayer Wound Matrix (Collagen-Glycosaminoglycan Matrix-Meshed),
and to differentiate it from the non-meshed version of the identical product.  According to the
requester, Integra Meshed Bilayer Wound Matrix is an advanced wound care device comprised
of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan with a
polysiloxane (silicone) layer. Integra Meshed Bilayer Wound Matrix is intended for the
management of wounds including: partial and full-thickness wounds, pressure ulcers, venous
ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds, trauma wounds and draining
wounds. The meshed bilayer matrix allows draining of wound exudate and provides a flexible
adherent covering for the wound surface.

Integra Meshed Bilayer Wound Matrix is packaged in sterile, single-use, double peel packages
containing phosphate buffer. It is available in 4 sizes: 500 square centimeters (8”x10” sheets),
250 square centimeters (4”x10” sheets), 125 square centimeters (4”x5” sheets), and 25 square
centimeters (2”x2” sheets).   The product is cut to the size of the wound size and applied
immediately following wound bed preparation. It should be firmly secured using surgical staples,
sutures, or other mechanical means. The requester comments that existing code C9363 is inadequate
for physician office billing, because this code is for use in the Hospital Outpatient setting
(for the purpose of billing Medicare). In order to capture a separate ASP payment the Meshed product
has been assigned to code Q4100 for the purpose of billing Medicare Part B, when used in the physician office setting.  As such, existing code Q4104 has not been assigned for the purpose of billing Medicare


Preliminary Decision:
   Existing code Q4104 "Integra bilayer matrix wound dressing (bmwd), per square centimeter"
adequately describes the product and is available for assignment by insurers, if they deem appropriate, for use in the physician’s office setting.Existing code C9363 “Skin Substitute, Integra Meshed Bilayer Wound Matrix, per square centimeter,” also adequately describes the product, and is available for assignment by insurers, if they deem appropriate, for use in the hospital outpatient setting.  For coding guidance, contact the insurer in whose jurisdiction a claim would be filed.