Tutopatch
Request to establish a new Level II HCPCS code to identify Tutopatch™ bovine pericardium.Applicant's suggested language: QXXXX - Tutopatch, per square centimeter
Background/Discussion:
RTI Surgical dba RTI Biologics, Inc., submitted a request for a new code to identify Tutopatch
(Bovine Pericardium). Tutopatch is indicated for use in general and plastic surgery applications.
It is intended for repair of pericardial structures and for use in surgical repair of soft tissue
deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle
flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias
(including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal and umbilical hernias).
Tutopatch 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. This process retains the original three-dimensional collagen
structure responsible for the multidirectional, mechanical properties of tissue. The typical patient
population is persons over the age of 18 who present with soft tissue repair needs.
The requester claims that there are no existing codes that describe Tutopatch.
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 Tutopatch, which is included
as part of the surgical procedure.
Tutomesh
Request to establish a new Level II HCPCS code to identify Tutomesh™ bovine pericardium.
Applicant's suggested language: QXXXX - Tutomesh, per square centimeter
Background/Discussion:
RTI Surgical, dba RTI Biologics,Inc.,requests a new code to identify Tutomesh, a fenestrated version of bovine pericardium tissue. According to the requester, Tutomesh 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. Tutomesh is used in general and plastic surgery applications.
It is a biological scaffold intended to be replaced by newly formed connective tissue through remodeling.
Tutomesh bovine pericardium is intended for use to reinforce soft tissue where weakness exists
in general and plastic surgery applications and is indicated f or repair of pericardial structures
and for use for surgical repair of soft tissue deficiencies including gastric banding muscle
flap reinforcement, repair of rectal prolapse using an abdominal approach, reconstruction of the
pelvic floor using an abdominal approach, and hernias. The typical patient population is adults
over the age of 18 who present with soft tissue repair needs.
The requester claims that there are no existing codes that describe Tutomesh. 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 Tutomesh, which is included
as part of the surgical procedure.
Cortiva
Request to establish a new Level II HCPCS code to identify Cortiva™, allograft dermis.Applicant's suggested language: QXXXX - Cortiva, per square centimeter
Background/Discussion:
RTI Surgical, dba RTI Biologic, Inc., submitted a request for a new HCPCS code to identify
Cortiva (allograft dermis). Cortiva 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 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. 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, which is included as
part of the surgical procedure
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