**Milwaukee Rheumatology Center, SC**

**Daniel H. Rosler,MD Allan L. Goldman, MD Nimali D. Mendis, MD**

**Board Certified Rheumatologists**

**2901 W KK River Prkwy, Suite 301, Milwaukee, WI 53215**

**Phone: (414) 672-8550 Fax: (414) 672-8551**

March 1, 2008

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

RE: Docket No. FDA-2008-D-0053

I am a rheumatologist in private practice, along with two other
associates. Pharmaceutical representatives visit my clinic almost on a
daily basis. I am a strong opponent of the FDA's draft proposal of
giving drug industry reps the right to hand physicians reprints of
journal articles containing the off-label use of their drugs. This
winter my office had a less-than-desirable experience with one of the
products (Rituxan) and the Medicare program. I would like to offer you
the details of such experience.

Rituxan is indicated for the treatment of rheumatoid arthritis in
combination with methotrexate in patients with moderate to severe active
RA who have had an inadequate response to one or more TNF antagonists
therapies (1). The dose is two 1000mg IV infusions separated by two
weeks (1-section 2.4). The safety and efficacy of retreatment have not
been established in controlled clinical trials (1-sections 2.4 and
5.14). As published by Medicare, the approximate allowable reimbursement
for one set of two infusions is **\$10,000.00**, inclusive of the 5
1/2-6 hr IV administration.

During initial and subsequent promotional efforts, representatives were
asked "what happens after the first set?" Their response was left to
"physicians discretion", although, data seemed to suggest retreatment at
6 months. No mention or clarification regarding the retreatment
statement in their FDA-approved package insert (PI) was ever made.

Half a year later my office became aware of another local colleague's
situation, in which a commercial payer (WPS) was denying
authorizations/payments for retreatment based on the "lack of an FDA
indication". My staff and I took a closer look at the product's PI and
it was then we realized the wording on retreatment. We contacted our
Rituxan representatives, since WPS is also our Medicare carrier (WI, IL,
MI, MN) and requested they obtain for us the medical policies addressing
**treatment and retreatment** for certain payers (Medicare included). In
the end, we were basically told that WPS (commercial) and WPS-Medicare
were 'separate entities"; that WPS-commercial was "a small payer"; that
"no other payers were having any issues with payments on retreatment",
and that "no claims have ever been denied by Medicare".

By then my office had gathered some information from visiting the web
site at CMS as well as WPS-Medicare, but it was not very clear. In
addition, and due to the representatives' unsatisfactory response as
stated above, in October 11, 2007 we contacted WPS-Medicare seeking
policy clarification.

In the meantime, my colleagues and I also contacted other
rheumatologists, both in and out of state, and soon realized not too
many of us were aware of the exact retreatment wording, as per PI. We
also became aware that a limited but certainly significant number of
other commercial payers across the nation already had medical policies
in place either not allowing or limiting the number of retreatment,
pending additional well controlled safety and efficacy trials. Once
again, we presented the reps with these findings, and they claimed "not
to be aware of it".

On December 14, 2007, Medicare notified us that retreatment was **NOT**
a covered benefit, and we were thanked for having brought this up to
their attention. Our inquiry was handled by Medicare's "more complex
inquiry department", ultimately reaching our carrier's medical director
(CMD). Medicare's decision was based on extensive research regarding the
existing published peer-to-peer clinical studies (which there were none,
since everything was in abstract form), as well as existing CMS and WPS'
regulations. However, our carrier was willing to revisit this decision
pending the outcome of additional data.

Again, we immediately notified Genentech and its reps, and even directed
our business manager to place a list-serve post in the American College
of Rheumatology web site, coding section, in order to make other
practices aware. We also asked of Medicare why payments continued to be
made for retreatment and were informed it was probably due to **lack
of** **an edit.** Nevertheless the payments were considered
**[improper]{.underline}**, and had the potential of being recovered
either by Medicare or by the RAC's (Recovery Auditing Contractors),
which, although not assigned to our state yet, could potentially do so
in other states. The response we continue to receive from the reps was
astonishing: we were perhaps 'the only" practice in the entire country
having issues w retreatment and Medicare...

Our patients now needed an unreasonable \$10,000.00 retreatment ABN in
file, which no one could afford. Patients also needed an explanation as
to why treatment could be started, but retreatment could not be
provided. The misinformation spread by the Rituxan reps created chaos
and confusion among the medical community; our patients; the payers; and
created the potential for financially collapsing entire practices as
well as improper billing of federal programs. In addition, as a federal
payer, Medicare's decision now affected beneficiaries in the Medicare
Advantage Plans (whose formulary usually covers what Medicare covers),
as well as enrollees in Medicaid, and only being a matter of time for
commercial payers to follow suit.

Fortunately, and shortly thereafter, the abstract information was
published in one of our peer review journals; we faxed it to the CMD and
on January 22, 2008 we received notification that retreatment **WAS** a
covered benefit. This change would require a revision to their LCD
(Local Coverage Determination) and a notification just appeared in this
month's Communiqué (2), positively impacting beneficiaries in the
following FOUR states: WI, IL, MI, and MN.

Letting the manufacturers continue to have an incentive to study their
drugs, as well as potential benefits and side effects, by going through
existing procedures is of great benefit for our patients. Saving
insurance payers, and taxpayers, millions of dollars of potential
improper payments resulting from widespread misinformation is also key.
If we need off-label information, we have always been able to obtain it
from the journals we read; or by requesting a query from the
manufacturer's medical departments; our local medical library; and even
our hospital's Pharm-D. I would like to suggest manufacturer's medical
liaisons be allowed to disseminate and make calls with such information,
upon request, provided their COMPENSATION PLAN IS NOT ATTACHED TO ANY
ALES INCENTIVE PROGRAMS.

Sincerely;

Daniel H. Rosler, MD

Medical Director

Milwaukee Rheumatology Center

<danielrosler@hotmail.com>

Attachments:

1)Rituximab PI

2\) March 2008 Communiqué-decision on rituximab retreatment