The American Society of Clinical Oncology (ASCO)
appreciates the opportunity to comment on medical
literature that could appropriately support
contractor decisions to reimburse under Medicare
for medically appropriate off-label uses of
cancer drugs. The decision by the Centers for
Medicare & Medicaid Services (CMS) to seek input
on this question is timely and necessary to
fulfill Congressional intent that contractors
have access to reliable medical literature when
making decisions about coverage of off-label uses
for cancer drugs.

We have reviewed the comments submitted on this
matter and believe that some of them identify
other reasonable candidates for inclusion in the
list of peer-reviewed journals that might offer
guidance to contractors. ASCO is particularly
interested in the supportive care journals that
several commenters referenced, as we agree that
supportive care has been an overlooked but very
important segment of cancer care in this
country. CMS should give careful consideration
to inclusion of one or more supportive care
publications.

While we endorse some of the additional
suggestions for included medical journals, ASCO
is concerned about the restrictive impulse
reflected in other comments that would seek to
limit the journals upon which contractors could
rely in covering off-label uses of cancer drugs.
In particular, the comments submitted by the
Center for Science in the Public Interest (CPSI)
seem not to appreciate the context in which § 1861
(t)(2) of the Social Security Act was enacted.

In the 1993 legislation, Congress sought to
address a pervasive problem of denials of
reimbursement by Medicare for off-label (or
unapproved) uses of cancer drugs when those uses
in fact represented the standard of care for many
cancers. Accordingly, Congress created a
mechanism under which the coverage decision was
taken away from Medicare and its contractors in
favor of reliance of independent medical
compendia referenced in the statute. At the same
time, Congress sought a system that would be
flexible and forward-looking so that coverage
decisions could be based on reliable evidence-
based information even before the compendia had
acted. Medicare contractors were thus authorized
to extend coverage to off-label uses of cancer
drugs where such uses were supported by clinical
trials as reported in high-quality peer-reviewed
medical journals.

In light of the expansive spirit of the 1993
legislation, the best way to identify those
journals is through the considered opinion of the
physician specialists who treat patients with
cancer. It is for that reason that the existing
list of journals was developed by CMS in
conjunction with input of expert opinion from
ASCO members. That list has served the system
well but is now in need of expansion, as
reflected in ASCO's communications with CMS in
2003 and 2006.

CSPI has urged that the list of medical journals
be limited in two respects—first, that no journal
be included that has not subscribed to a
requirement of clinical trial registration; and
second, that no journal be included that does not
disclose conflicts of interest. In the abstract,
ASCO agrees that these two criteria are among the
appropriate indicia of quality in scientific or
medical journals, but they are not the only
significant criteria, and they should not be
utilized to foreclose otherwise appropriate
coverage. For purposes of the Medicare law,
which sought to expand patient access to off-
label uses of cancer drugs, use of these narrow
criteria to restrict patient access to
potentially life-extending therapies is
inconsistent with Congressional intent.

The criteria urged by CSPI involve important, but
still evolving, guidelines for medical
publications. The requirement of registration of
clinical trials as a precondition for publication
surfaced several years ago, and most medical
journals are moving toward acceptance of this
requirement. The details of compliance remain to
be resolved, however, and it is by no means clear
what the final contours will entail, probably
several years hence. Significantly, several
legislative proposals—with different criteria for
compliance—have been introduced, with the outcome
to be determined in the next Congress, if then.
It would be imprudent to draw bright lines for
compliance with clinical trial registration
requirements at this premature stage in the
development of this policy.

The same is true for disclosure of conflicts of
interest. As with clinical trial registration,
disclosure of conflicts of interest is viewed
extremely favorably by ASCO, and in fact ASCO has
long required such disclosure in its publications
and other activities. It is important to
recognize, however, that different journals are
in varied stages of development in incorporating
these standards, and patient access to life-
extending therapies should not be jeopardized
because some journals have not yet brought their
practices into line with the latest thinking on
these matters.

ASCO also disagrees with the suggestion from
Trailblazer's Medical Director that Journal
Impact Factor (JIF) be a decisive consideration
in selecting journals for coverage purposes.
Such a consideration would work well for journals
like ASCO's Journal of Clinical Oncology, but
would not be appropriate for journals dealing
with orphan diseases like various blood cancers
or with other relatively targeted sub-specialty
interests that might be cited less frequently
simply because of the smaller numbers of patients
and treating physicians. The impact of medical
journals cannot be measured solely in the numbers
of citations they accumulate. Like the
suggestion of CSPI, Trailblazer's recommendation
is too formulaic to take into account the quality
of the peer review and the nature of the clinical
research being reported in the journal's pages.

In general, ASCO believes that the historic
approach by CMS, relying on the judgment of
physician thought leaders, has worked well. The
application of external criteria not directly
related to the quality of the clinical research—
registration requirements, strong conflicts rules
or journal impact factor—is off the point of the
1993 legislation, which was to expand and ensure
patient access to medically appropriate cancer
therapies, regardless of whether they are
explicitly approved by the Food and Drug
Administration. We urge CMS to adhere to the
spirit as well as the letter of the 1993
legislation and allow science, medicine and
clinical judgment to guide the development of the
list of medical journals for the purpose of
implementing § 1861(t)(2).