September 28, 2008

Submitted electronically

Dr. Barry Straub
Centers for Medicare and Medicaid Services
Coverage and Analysis Group
7500 Security Blvd
Baltimore, Maryland

Dear Dr. Straub;

On behalf of the Alliance of Wound Care
Stakeholders (“Alliance”), I am pleased to
present comments regarding CMS’ request for
comments on a list of potential topics for future
National Coverage Determinations (NCD). The
Alliance is a multidisciplinary consortium of
over 15 physician, clinical, provider,
manufacturer and patient organizations whose
mission is to promote quality care and patient
access to wound care products and services. Many
of the physician and clinical organizations who
participate in the Alliance have many members
that also conduct clinical research in the areas
of wound care. These comments were written with
the advice of the following Alliance
organizations who possess expert knowledge in
complex acute and chronic wounds as well as in
wound care research. These include: Association
for Advancement of Wound Care, American
Professional Wound Care Association, the American
College of Hyperbaric Medicine, American College
of Certified Wound Specialists, and American
Association of Wound Care Management.

On July 30, 2008, the Centers for Medicare &
Medicaid Services (CMS) released a list of
potential topics for future National Coverage
Determinations (NCDs). While many topics were
identified in that document, the Alliance is
particularly interested in the question, “Is the
evidence for any specific modalities adequate to
demonstrate improved health outcomes for selected
wound patients while avoiding side effects seen
with other growth hormones?”

Our comments revolve around these issues:
clarification of the topic, evaluation and the
CMS process for quarterly posting of potential
NCD topics on the coverage website.

Needed Clarification Regarding Issues on This
Topic
In order to submit comments that are relevant to
the questions asked, the Alliance would like
clarification on the following points regarding
this topic:
 Specifically, what types of wound care
patients are CMS referring to?
 What type(s) of biologic therapy are CMS
referring to?
 Is CMS trying to address growth factors
and autologous growth factors? The Alliance
participants are confused by the question, as it
appears CMS is only addressing biologic therapies
that have growth hormones - such as Regranex.
Is this a correct assumption? If not, what
products is the Agency trying to address in this
NCD proposed topic?
The Alliance would like to point out that there
are several components to biological therapies
for the treatment of chronic wounds. There are
biological skin substitutes and there are
biological growth factors. Biological skin
substitutes do not have growth hormone effects
since they are varied by layers of dermis,
epidermis or a cellular matrix that support the
natural scaffolding structures of the body’s own
cells to resurface wounds. The Alliance believes
that the LCD process is working well for
bioengineered skin substitutes.
Since it is unclear what CMS is seeking and more
information needs to be ascertained before
stakeholders can provide adequate, objective
feedback, the Alliance recommends that CMS not
issue an NCD for biologic therapies for the
treatment of chronic wounds at this time.
Furthermore, the Alliance submits that it would
be premature for CMS to consider this issue under
a NCD until clarification has been provided on
these questions to all stakeholders in this
arena.
While the Alliance does not agree with biologic
therapies for the treatment of chronic wounds as
a topic for an NCD at this time, if CMS considers
moving forward, the Alliance recommends that the
Agency consider evaluating biologics as follows:
• Categorize the types (i.e. – skin or
tissue matrix, topical gel, human or xeno, living
or non living) as well as the delivery methods of
biologics used to treat chronic wounds.
• What is the route of administration – is
the biologic administered by the physician or the
patient?
• Focus on the Food and Drug Administration
(FDA) indications for use and chronic wound type.
In addition, the Alliance would like to address
an item the Agency put forward in your topic
question – specifically regarding the safety of
biological therapies. While the Alliance is not
addressing any specific growth hormone products,
the safety record of biological therapies has
been well established through the FDA approval
and clearance process as well as from clinical
practice. Safety should not be an issue.


Concerns Regarding CMS Process for Quarterly
Posting of Potential NCD Topics on its Coverage
Website.

The Alliance also has the following concerns from
a stakeholder perspective regarding this
process:
 Will CMS be updating the list of topics
quarterly?
 Will CMS be collating and responding to
the specific comments received by interested
stakeholders?
 Will CMS be publishing what the next
steps will be?

These aspects are just a few that we have
identified in which CMS needs to address.

Conclusion

The Alliance thus recommends that CMS not move
forward with an NCD for biological therapies for
the treatment of chronic wounds at this time.
CMS must clarify what they are seeking in the
earlier question posed and, once clarified, issue
a revised draft for further discussion and
comment.
The Alliance appreciates the opportunity to
provide our comments and looks forward to working
with the Agency to address the issues discussed
in this letter. We are happy to serve as
resource for you to discuss wound care issues
such as these in the future. Please contact me
directly if you have any questions or concerns.
Sincerely,


Marcia Nusgart R.Ph.
Executive Director