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					                                         Gamma Graft
                                      Sample Appeals Letter

Date:                                                                 Patient
                                                                      Policy Holder
                                                                      ID/Social Security #
                                                                      Contract #

Insurance Company
City, State, Zip
Attention: (Name)

Dear _________:

I am writing to request reconsideration of your decision to deny payment for the application of
Gamma Graft used for the treatment of (Patient Name)’s (type of wound) on (insert date of
service here), who is insured by your company.

Paragraph #2:

   Describe the patient’s condition
   Document current findings/status
   Document chronological history

(Patient name) clearly benefited from the use of GammaGraft.

   Describe how the patient benefited from the use of GammaGraft: (ex. Wound has
   Recommend considerations for use of GammaGraft

The use of allograft skin obtained from human cadavers is considered to be the gold standard
treatment to provide temporary wound closure when the patient’s own skin is not available.
Allograft is self-adhering, renders the wound site pain free, and acts as a vapor barrier that limits
fluid and protein loss from the wound while preventing infection. Use of cadaver skin has been
limited to use in the hospital setting due to handling requirements.

GammaGraft is human skin allograft acquired from cadaveric donors that has been irradiated to
allow for storage at room temperature. GammaGraft has both the epidermal and the dermal
layers of human skin which makes it more durable and effective as a vapor barrier than most
wound covers, especially some artificial skins, which lack a keratinocyte layer (found in the
epidermis). Its main applications are as a temporary graft for treating burns, chronic wounds,
and partial and full thickness wounds.

The irradiation process that GammaGraft undergoes produces two key advantages. The
irradiation acts as a preservation and sterilization agent significantly reducing any risk of viral
transmission of disease and allowing it to be stored at room temperature for up to two years.
This is an added precaution to eliminate viruses beyond the extensive serological testing done
by the tissue banks to ensure virus-free skin. In fact GammaGraft has been treated so as to
greatly reduce the threat of CMV (cytomegalovirus). It is therefore ideal for use in transplant
patients, HIV positive patients, and other people with compromised immune systems who could
be adversely affected by CMV.

It is important to draw the distinction between GammaGraft and other tissue engineered skin
substitute such as Apligraf. Unlike Apligraf and the other skin substitutes which are regulated
as devices by the FDA, GammaGraft is regulated by the FDA as human tissue because it is
donated human skin and not an engineered product. Furthermore, the Centers for Medicare and
Medicaid Services recently published their intent to establish a unique billing code for
GammaGraft in recognition of the fact that the existing codes describing tissue engineered skin
substitutes do not apply to GammaGraft as is the case with fresh or frozen cadaver skin as well.
This new code will become available January 1, 2009 until which time it is necessary to bill for
the product using the unlisted biologic code J3590.

Insert the following if standard cadaver grafts are covered by the plan:

Since GammaGraft is actually human cadaver skin and is regulated similarly by the FDA, it
should be covered just as non-irradiated cadaver skin is under your policy.

Insert the following if unsure about coverage status of cadaver grafts:

The use of human allograft skin is considered to be the standard of care when there is a need
for temporary wound closure. GammaGraft is human cadaver skin; but, with the additional
advantages offered by the irradiation process. As such, it should be considered for coverage by
(insert insurance company name).

I have included some information about GammaGraft as well as the patient’s medical records
for your review. I think that once you learn more about the product, you will agree that this claim
should in fact be paid. I would like the opportunity to discuss this matter with you further. I will
contact you on (Date) to schedule a time for us to discuss this appeal. In the meantime, if you
have any questions, please contact me.


____, M.D.


Summary of relevant clinical articles
Product Information
Patient Medical Records

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