DRUG AGENDA - May 2015

AmnioGen-A

       Request to establish two new Level II HCPCS codes to identify injectable liquid placental tissue
matrix:  one to identify a cryopreserved version of the product, AmnioGen – C; and another to identify an ambient version, AmnioGen-A.

Background/Discussion:
       US Biologix, LLC submitted a request to establish two separate HCPCS codes to identify
AmnioGen-C and AmnioGen-A injectable liquid placental tissue Matrix.  According to the requester, both are amniotic membrane product in particulate form obtained fromd onated human placental tissue.  Both are intended to facilitate replacement or supplement damaged or inadequate integumental tissue.  They are intended to be used as a physical wound covering, a foundation for regeneration, modulate correct tissue reconstruction, and to regulate inflammation and pain. Amniotic membranes are a rich source of ExtraCellular Matrix proteins that provide the foundation for the body’s tissues and organs. 

     Both products are prepared by the physician as a suspension with normal saline for injection.  Both are products are supplied as a single-dose vial, and are available in three different doses:  0.5cc, 1.0cc and 2.0cc.  AmnioGen-C is cryopreserved.  AmnioGen-A is ambient.  The requester comments that new codes are warranted because there are no existing codes that describe these products.

Preliminary Decision:
  Establish QXXXX, AmnioGen-C and AmnioGen-A, 0.5cc.

AmnioGen-45

Request to establish two new Level II HCPCS codes to identify an amniotic membrane allograft:
one to identify a 45 micron thick version, AmnioGen-45; and another to identify a 200 micron
thick version, AmnioGen-200.


Background/Discussion:
 US Biologix, LLC submitted a request to establish two separate HCPCS codes to identify AmnioGen-45 and AmnioGen-200 amniotic membrane allografts. Both products are amniotic membrane allografts derived from electively donated placental tissue.  Both grafts are intended to be used as a physical wound covering, a foundation for regeneration, modulate correct tissue reconstruction, and to regulate inflammation and pain.Both are preserved through a proprietary, patented method.  Both are supplied as a single-use biologic available in six different sizes:  1x1 cm, 2x2 cm, 2x4 cm, 4x4 cm, 4x6 cm and 4x8 cm.  AmnioGen membrane comes in two sizes, a thin membrane (45 microns) and a thicker membrane (200 microns). The requester comments that new codes are warranted because there are no existing codes to describe these products. 

Preliminary Decision:
     A national program operating need was not identified by Medicare, Medicaid or the Private
Insurance sector to establish HCPCS code(s) to separately identify these products, which are 
included as part of the surgical procedure.

MiroDerm

Request to establish a unique Level II HCPCS code to identify a porcine-derived, non-crosslinked  acellular wound matrix, Trade Name: MIRODERM. Applicant's suggested language: Q41XX - MIRODERM, per square centimeter


Background/Discussion:
      A request was submitted on behalf of Miromatrix Medical, Inc. to establish a new code to
identify MIRODERM.  According to the requester, MIRODERM, an extracellular matrix wound
care product.  It is a bioengineered skin substitute derived from porcine liver, processed and stored in a phosphate buffered aqueous solution. MIRODERM is indicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, drainage wounds, trauma wounds and surgical wounds. It provides a scaffold to maintain and support a healing environment through constrictive remodeling. MIRODERM is supplied in 17 varying sizes, ranging from 4 sq. cm to 200 sq. cm. According to the requester, a new for MORODERM is warranted in order for payers to accurately and efficiently administer claims and coverage policy.


Preliminary Decision:
       A national program operating need was not identified by Medicare, Medicaid or the Private
insurance sector to identify MIRODERM, which is included in the procedure.

Plurivest

Request to establish a unique Level II HCPCS code to identify a human placental connective
tissue matrix, Trade Name Plurivest.  Applicant's suggested language: Plurivest™, per square
centimeter.

Background/Discussion:
   Aedicell, Inc. submitted a request to establish a new code to identify Plurivest.  According to the requester, Plurivest is a human placental connective tissue matrix, available in sizes: 2x3 and 4x4 cm. Plurivest is intended to replace or supplement damaged or inadequate integument.Plurivest may be clinically indicated for patients with partial and full thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds, drainage wounds and surgical wounds. The attachment protein, growth factor and structural aspects of the placental connective tissue matrix act as a scaffold for cell infiltration and proliferation.

The requester comments that a new HCPCS code is warranted to identify Plurivest because
there is no existing code that describes it.

Preliminary Decision:
    Revise existing code Q4153 which currently reads:  “Dermavest, per square centimeter”, to instead
read:  “Dermavest and Plurivest, per square centimeter”.  The revised code adequately describes the
product that is the subject of this request.