DRUG AGENDA - May 2015

Bio-ConneKt Wound Matrix.

      Request to establish a new Level II HCPCS code to identify bio-ConneKt Wound Matrix.
Applicant's suggested language: Q41XX -Bio-ConneKt Wound Matrix, per square centimeter

Background/Discussion:
      MLM Biologics submitted a request to establish a new HCPCS code to identify Bio-ConneKt
Wound Matrix.  According to the requester,Bio-ConneKt is a bioengineered skin substitute derived from equine Type I collagen. Bio-ConneKt is intended for management of moderately to heavily exuding wounds, including partial and full thickness wounds, draining & tunneling wounds, pressure sores/ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds, and surgical wounds.

The product is placed directly into the wound site and incorporates into the wound, as the wound heals. Bio-ConneKt is supplied in 4 different sizes: 6 cm x 7 cm, 5 cm x 5 cm, 3 cm x 3 cm, and 2 cm x 2 cm.  It comes in a double pouch package and in a final outer cardboard envelope.  The product is trimmed to a size slightly larger than the outline of the wound, then affixed to the wound and covered with a standard, non-adherent surgical dressing. The requester comments that a brand-specific code is needed to identify Bio-ConneKT in order for the payers to accurately and efficiently administer claims and benefits.


Preliminary Decision:
    Establish QXXXX, Bio-Connekt Wound Matrix, per square centimeter.

EpiFix

Request to expand the Q41XX code series in order to distinguish coded products based on size
and other product characteristics.  Specifically, to create a coding distinction between Epifix
products that measure more than 20 square centimeters vs. all other (smaller) sizes. 

Applicant’s suggested language:  Revise existing code Q4131 which currently reads “EpiFix, per square centimeter”; to instead read “Human dehydrated amniotic membrane allograft, EpiFIx®,
for sizes up to 20 square centimeters, per square centimeter”; and Establish a new code: QXXXX - Human dehydrated amniotic membrane allograft, EpiFix® for sizes 20 square centimeters and above, per square centimeter.


Background/Discussion:
      MiMedx Group, Inc. submitted a request to revise existing Epifix code Q4131, by adding
language that would limit its application to only product sizes up to 20 square centimeters. 
MiMedx Group also requests the establishment of a new code in the same series to identify Epifix in
sizes 20 square centimeters and above.EpiFix is a multi-layer biologic dehydrated human amnion/chorion membrane allograft comprised of an epithelial layer and two fibrous connective
tissue layers processed from human placenta. 

The processed allograft contains collagen types IV, V and VII that promote cellular differentiation and adhesion. EpiFix is used in wound care where it is necessary to repair or replace lost or damaged human collagen tissue. The actions of EpiFix for wound repair include: providing a matrix for cellular migration/proliferation, promoting increased healing, it is non-immunogenic, natural biological barrier, contains essential growth factors, reduces inflammation, reduces scar tissue, has antibacterial properties and reduces the pain at the site.EpiFix allografts are placed on the wound site and hydrated as necessary. The size needed is determined based upon the size of the wound defect.

The requester claims that existing code Q4131 does is insufficient to accurately describe EpiFix,
because of the wide range and variety of sizes offered, and that coding distinctions based on size
will “facilitate the establishment of a lower payment rate, thus affording medical providers a
more cost effective way to provide the best care to patients with larger wounds.” 


Preliminary Decision:
      Existing code Q4131 "Epifix, per square centimeter" adequately describes the product that is the
subject of your request, and permits reporting of the number of units administered, to accommodate all sizes.

CartiForm

Request to establish a unique Level II HCPCS code to identify an osteochondral allograft, Trade
Name:  Cartiform®.  Applicant's suggested language: JXXXX -1 centimeter squared, Cryopreserved Viable Osteochondral Allograft.


Background/Discussion:
   Osiris Therapeutics submitted a request to establish a HCPCS code to identify Cartiform®. 
According to the requester, Cartiform is a cryopreserved viable osteochondral allograft, processed from donated human osteochondral tissue. Cartiform contains all necessary components for cartilage reconstruction and tissue repair, and is the only cartilage repair product with viable chondrocytes within an intact native cartilage architecture that can be stored frozen for immediate, point-of-care use.It is used to treat articular cartilage defects for a patient population similar to those that would undergo a micro fracture, fresh-stored osteochondral allografting and/or ACI/ Carticel procedures.  Cartiform is safe for patients 55 and younger with at least 6 months of symptoms, radiographic evidence of normal joint space, no evidence of inflammation or osteoarthritis, stable ligaments, adequate meniscus, no malalignment with focal, full thickness Grade 3-4 isolated lesions up to 10 cm caused by acute or repetitive trauma. The surgical technique depends on the defect location, size and physician preference.

Cartiform can be implanted arthroscopically or following an arthrotomy or mini-arthrotomy to expose cartilage defect. The quantity used will vary based upon articular cartilage lesion size and physician recommendation. Cartiform is packaged as a circular disc, stored frozen, and is available in 2 sizes: 20 mm diameter disc and 10 mm diameter disc.

The requester comments that a new code is warranted for Cartiform because there are no HCPCS
codes that accurately describe it.


Preliminary Decision:
      A national program operating need was not identified by Medicare, Medicaid or the Private Insurance sector to establish a HCPCS code to separately identify Cartiform, which is included as part of the surgical procedure.