Thursday, September 25, 2008

Steve E. Phurrough, M.D.
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard – Room C1-13-18
Baltimore, Maryland 21244-1850

Re: Potential NCD Topic – Biological
therapies for the treatment of chronic wounds

Dear Dr. Phurrough:

Thank you for the opportunity to comment on the
Potential National Coverage Determination [NCD]
Topics for the third quarter of 2008 as posted
Wednesday, July 30, 2008, on the Centers for
Medicare and Medicaid Services [CMS] Medicare
Coverage Database webpage.

LifeCell Corporation has prepared the following
comments in response to the potential NCD topic -
Biological therapies for treatment of chronic
wounds.

Since 1994, LifeCell’s patented regenerative
tissue matrices allow surgeons to restore many
types of soft tissue damaged through disease or
injury. LifeCell develops and markets tissue
repair products for use in reconstructive,
urogynecologic and orthopedic surgical
procedures. LifeCell''s current products include:

 AlloDerm® - for plastic reconstructive,
general surgical, burn and periodontal
procedures;
 AlloDerm GBR® 1 - for periodontal
procedures;
 Strattice® - for reconstructive and
general surgical procedures;
 Cymetra® - a particulate form of AlloDerm
suitable for injection;
 Repliform® 2 - for urogynecologic
surgical procedures;
 GRAFTJACKET® 3 - for orthopedic surgical
procedures and lower extremity wounds;
 GRAFTJACKET® Xpress3 - for repair of
damaged or inadequate integumental tissue; and,
 AlloCraft™DBM 4 - for bone grafting
procedures.

Currently, the majority of these biological
technologies are used for acute procedures.

At this time, LifeCell does not believe a NCD for
biological therapies for the treatment of chronic
wounds is necessary. Currently, there is general
consistency among the contractors and their
various Local Coverage Determinations [LCDs],
particularly for biological tissue/skin
substitute products. Additionally, there does
not appear to be uncertainty or confusion on the
part of providers treating patients with chronic
wounds with biologicals. Finally, when these
products are used according to their Instructions
or Directions for Use the effectiveness, patient
outcomes and safety are well documented and
positive.

If in the future CMS considers a NCD for
biologicals for the treatment of chronic wounds
necessary, we suggest CMS select biologicals for
evaluation based on the following factors and
considerations:

 Specifically select the type of
biological to evaluate [e.g., skin or tissue
matrices, growth factor products; topical gel;
human or xenogeneic based products] - the AMA
CPT® definitions may be a helpful guide.

 Chronic wound types [arterial, diabetic
foot, pressure and venous leg ulcers], clinical
application and usage [physician surgically
implanted or patient administered], and care
setting. For instance, biologicals indicated for
acute use should not be evaluated for chronic
uses.


At this time, and until the NCD topic can be more
specifically defined, we recommend CMS not move
forward with a NCD for biological therapies for
the treatment of chronic wounds.

Thank you for the opportunity for LifeCell
Corporation to express our views on the potential
NCD topic - Biological therapies for treatment of
chronic wounds.

Best regards,


Mary E. Hayter
Vice President, Government Affairs and Health
Economics


___________________________________

1 AlloDerm GBR® is distributed by BioHorizons,
Inc.
2 Repliform® is distributed by Boston Scientific
Corporation.
3 GRAFTJACKET® and GRAFTJACKET® Xpress are
distributed by Wright Medical Technology, Inc.
4 AlloCraft™ DBM is distributed by Stryker
Corporation.