On behalf of Johnson & Johnson, I am pleased to
submit comments and recommendations in response
to the Posting of Potential National Coverage
Decision Topics.

Johnson & Johnson (J&J) is the world’s most
comprehensive and broadly-based manufacturer of
health care products for the consumer,
pharmaceutical and medical devices and
diagnostics markets. For 120 years, J&J has
supplied hospitals with a broad range of products
and has led the way in innovation; from the first
antiseptic bandages and sutures to the first drug-
eluting stents. The consistent fundamental
objective of J&J is to provide scientifically
sound, high quality products and services to help
heal, cure disease and improve the quality of
life.

On July 30, 2008, the Centers for Medicare &
Medicaid Services (CMS) posted on its web site a
list of 19 potential NCD topics, and indicated it
was requesting comments on the list by September
28, 2008. The agency committed to posting such a
list in a previous guidance document on the
Medicare coverage process.

We acknowledge and appreciate CMS’ effort to
increase the transparency of its NCD process by
releasing this list prior to initiating formal
national coverage analyses.

Our comments below focus on topics related to the
process for compiling and releasing the list, and
we seek clarification on several questions
related to the process going forward. We also
raise some concerns about preserving the role of
physician judgment at the same time we move
toward more evidence-based medicine. In
addition, several of J&J’s operating companies
are submitting separate comments relating to
individual topics identified on the list.

Identifying Topics to be Included on the List

CMS used the seven circumstances that were
identified in a prior guidance document on the
NCD process to identify topics included on the
list of potential NCD topics. While this is
generally helpful to understand the process to
identify the topics that were included, it would
be helpful to provide more detail into the
questions CMS has about any of the specific
circumstances for each topic.

For example, CMS has included hip resurfacing and
ablation for atrial fibrillation on the list
without discussing any particular concern related
to any of the seven circumstances other than
generally questioning whether there is evidence
of a health benefit from these procedures. While
the seventh circumstance on the list
is “significant uncertainty about the health
benefit,” there is no indication from CMS why it
has significant uncertainties about these
technologies.

As noted above, we support the efforts CMS is
taking to increase the transparency of the NCD
process. By identifying areas of potential
concern prior to initiating a formal NCD, there
will be greater opportunity for collaborative
discussions that should improve the overall
process. We believe this objective would be
served by a more thorough narrative discussion of
the concerns CMS has with each topic than was
provided in this initial list.

We would also urge CMS in the future to identify
for each topic on the list whether it was
recommended internally, or if the request for
review was received from a source external to the
agency. This is important to ensure full
transparency of the process. In some cases,
external sources may have conflicts of interest
related to a particular device or procedure, and
that should be disclosed as well.

A few of the topics on the list are aimed at uses
of a treatment that is under review by the Food
and Drug Administration (FDA). CMS should
clarify that it will await FDA’s decision before
proceeding with an NCD. FDA should make the
determination of safety and efficacy before CMS
opens a national coverage decision to
determine “reasonable and necessary.”

Several of the topics represent procedures that
are not primarily performed in the Medicare
population. We encourage CMS to focus its NCD
process on treatments or procedures that affect a
large number of Medicare beneficiaries.
Particularly where there may be limited data
available for Medicare beneficiaries, overly
restrictive Medicare policies may encourage
subsequent coverage limitations for broader
patient populations more likely to benefit.
While we understand CMS’s primary concern is to
ensure that services received by its
beneficiaries are reasonable and necessary, the
agency also should be cognizant of its influence
on other payers.

Uncertainty Regarding Next Steps

At this time, it is not clear what next steps
there will be relative to the list after the
close of the public comment period, short of
waiting to see whether an NCD is issued.
Especially given the extensive effort that many
of the commenters have undertaken to assimilate
their comments, we would encourage CMS to
establish a formal process for responding to the
information provided. Publishing the agency’s
responses to the comments will provide further
transparency by helping clarify the final
criteria used by CMS in selecting NCD topics.

A recurring question raised about the topics on
the list was whether there is evidence of a
benefit. We recommend that CMS respond whether
it is satisfied with the available evidence after
reviewing the comments, or if unanswered
questions remain. Where CMS has concerns about
continuing or providing coverage, CMS should
indicate in more detail what its concerns are.

The list is described as the First Quarterly
Release, but it is unclear whether CMS intends to
release four lists per year. We recommend CMS
provide additional guidance about its intentions
with regard to the frequency of the list and
whether items will remain on the list until CMS
is satisfied its concerns have been addressed, or
until an NCD is initiated. Also, the agency
should clarify whether future NCDs will be
initiated only after first appearing on this
list. In general, it would be helpful if CMS
could articulate how it will prioritize which
treatments or technologies it considers for NCD
development.

Role of Physician Judgment Should be Preserved

It is important that CMS proceed cautiously in
its consideration of the topics on this list to
avoid any unnecessary disruption in patient care
for Medicare’s beneficiaries. Several of the
topics are well-established procedures that help
patients every day who are facing serious, and
sometimes life-threatening, health problems. It
is clear there is a need for ongoing evidence
generation to continually advance the
understanding of what treatments work and for
which patients. All of us involved in the health
care system owe that to the patients who rely on
us.

But there is also risk that dramatic shifts in
Medicare coverage policies, even when well-
intentioned with the goal of improving the
evidence base for what works, could lead to
restricted access for patients who would benefit
from a treatment. CMS should try to balance its
role in encouraging development of better
evidence to support patient care with allowing
physicians to treat patients using the best
information at their disposal. CMS should
acknowledge that the NCD process, even coverage
with evidence development, is not meant to
eliminate all uncertainty in health care.
Physician decision-making based on the available
evidence for a range of treatment options is a
critical aspect of good patient care, and
coverage policies must take that into account.

J&J appreciates the opportunity to submit our
comments and recommendations to CMS. We look
forward to working with you and your staff on
these issues.

Sincerely,



Kathleen A. Buto