DRUG AGENDA - May 2015

Cortiva 

Request to establish a new Level II HCPCS code to identify Cortiva™, 1 mm allograft dermis. 
Applicant's suggested language: QXXXX -Cortiva, 1 mm, per square.

Background/Discussion:
    RTI Surgical, dba RTI Biologic, Inc., submitted a request for a new HCPCS code to identify
Cortiva 1mm (allograft dermis).  Cortiva, 1mm is a sterile, dehydrated dermis from donated
human tissue. It is preserved by the Tutoplast process, whereby low-dose gamma irradiation is
applied terminally to the product to achieve a sterility assurance level of 10-6, while preserving
structural integrity. Cortiva, 1mm is an implant regulated as a 361 human cell and tissue product
(HCT/P) and restricted to homologous use for the repair, replacement, reconstruction or
augmentation of soft tissue, including supplemental support and reinforcement of soft tissue in
hernia repair.The requester claims that there are no existing codes that describe Cortiva, 1mm. 
A code is needed in order to process claims and track costs.  Currently, miscellaneous skin substitute code Q4100 is being used to identify this product on claims.

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 Cortiva, 1mm, which is
included as part of the surgical procedure.

HPTM

Request to establish a new Level II HCPCS code to identify a porcine-derived, non-cross linked,
cellular dermal matrix surgical mesh, Trade Name HPTM.  Applicant's suggested language: Q41XX -
HPTM, per square centimeter.


Background/Discussion:
      LifeCell Corporation requests the creation of a new HCPCS code to identify HPTM, a sterile,
porcine derived, non-cross linked biologic, acellular tissue matrix surgical mesh. HPTM is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes which require the use of reinforcing or bridging material to obtain the desired surgical outcome.  The implant is intended for reinforcement of soft tissue in plastic and reconstructive surgery.  Once applied by a surgeon, HPTM supports revascularization, cell repopulation and white cell migration while providing mechanical support. 

The surgeon determines the most appropriate size and shape of HPTM to use on the patient.
Each package contains one piece of HPTM, an outer carton, an outer foil package containing a
sterile inner foil pouch with HPTM. The requester comments that a new code is necessary in order
to provide for greater coding accuracy and utilization documentation for providers and insurers
when billing for the use of this product.


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 HPTM, which is included as
part of the surgical procedure.

Ologen

Repeat request to establish a unique Level II HCPCS Q-code to identify a porcine-derived
collagen matrix, Trade Name:  Ologen®Applicant's suggested language: QXXXX-Ologen®
Collagen Matrix, per unit.

Background/Discussion:
        A request was submitted on behalf of Aeon Astron Europe BV, for a HCPCS code to identify
Ologen Collagen Matrix. According to the requester, Ologen Collagen Matrix is a medical device made of atellocollagen which is derived from porcine skin. This atelocollagen is cross-linked and lyophilized with glycosaminoglycan to obtain Ologen collaten Matrix.  It is configured to support and mudultate wound healing in connective and epithelial ocular tissue, and is used exclusively in ophthalmic surgery procedures such as glaucoma filtering surgery, primarily in the trabeculectomy surgical procedure.

The requester claims that there is a “significant therapeutic distinction” between Ologen and other collagen matrices, in that none of the other matrices are indicated by the FDA for ophthalmic surgery.


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 Ologen Collagen Matrix,
which is included as part of the surgical procedure.