Kerry Weems, Acting Administrator

Centers for Medicare and Medicaid Services

Department of Health and Human Services

Attention: CMS-1390-P

P.O. Box 8011

Baltimore, MD 21244-1850

> Re: CMS-1390-P (Medicare Program; Proposed Changes to the Hospital
> Inpatient Prospective Payment Systems and Fiscal Year 2009 Rates)

Dear Administrator Weems:

I appreciate the opportunity to comment on the recent proposed rule
regarding payments for inpatient hospital services, specifically, the
TherOx submission for additional reimbursement under the "New Technology
Add-On Reimbursement" policy. By way of introduction, my name is David
G. Rizik, M.D., Director of Interventional Cardiology at the Scottsdale
Healthcare Hospitals in Scottsdale, Arizona. I would add that I have
worked with Ann Fagan previously and served in a consultant capacity to
her, conducting several clinical presentations on bifurcation coronary
artery treatment.

As it relates to my work in acute myocardial myocardial infarction
(AMI), I have been a principle investigator for numerous AMI studies,
with specific interest on myocardial salvage trials. Specifically, I was
one of the principle investigators and leading enrollers in the COOL MI
study examining endovascular temperature therapy to salvage myocardium
in A.M.I. I was also involved in the AMIHOT I trial, the focus being the
TherOx system in A.M.I. I have numerous publications in peer review
journals on myocardial salvage in general as well as the subject of
Super-Saturated Oxygen.

Because of my experience, I read with keen interest the discussion of
the Downstream System in the proposed rule and wanted to provide you
with my comments on that. The pivotal A.M.I.H.O.T. trials taken in
aggregate provide our patients (for the first time in history) a
reasonable and effective means of salvaging myocardium. These patients
have no other options and therefore, the positive results of these
trials take on added importance.

It is important to review several key data sets regarding the success of
Super-Saturated Oxygen (SSO) delivery and the AMIHOT Trials. First, that
the administration of SSO does not delay the door to balloon time in
these patients distinguishes it from all previous mechanical attempts at
achieving myocardial salvage in AMI. It allows physicians and healthcare
systems to effectively treat patients, while still meeting the need for
90 minute door to balloon time, a treatment parameter mandated by both
CMS and the American College of Cardiology (ACC).

The clinical significance of a 6.5% absolute (26% relative) reduction in
infarct size cannot be underestimated. However, the AMIHOT II data is
even more compelling when looked at in the context of the highest risk
subgroup. In those patients whose initial ejection fraction is less than
40%, there is a reduction in infarct size of nearly 36%. Moreover, there
is a relative reduction in infarct size irrespective of initial TIMI
flow in the culprit vessel (TIMI 0/1: 25% infarct size reduction; TIMI
2: 85.7% reduction in infarct size).

In our world (that is to say, the world of treating physicians who bear
the responsibility of multiple hospitalizations and expensive device
management in post-MI patients due to extensive myocardial damage
acutely), this has the potential to reduce repeat hospitalizations,
reduce cost in the first year following the index event, and improve the
quality of life of these unfortunate individuals.

It would seem logical that the Centers for Medicare and Medicaid
Services view with enthusiasm any device that has the potential to
reduce the cost of medical care and improve quality of life, two
treatment descriptors that often are inexorably linked. For these
reasons, I do believe that the Downstream System will represent a
substantial clinical improvement compared to the existing technologies
and likely "set the standard" for all future devices in this field of
clinical investigation.

In the proposed rule, you indicate that some data showed a higher
incidence of bleeding complications for patients treated with the
Downstream System. As a reminder, the MACE rates of the two AMIHOT
trials, taken in aggregate were well within the target rates for the
study. I think there is also the common sense issue that as this
technology matures ( i.e. growing operator experience and iterative
advances in the administration of SSO), we can expect improvements in
the safety profile of this device. As an example, during the infancy
stages of stent technology 15 years ago, the initial rates of acute and
subacute stent thrombosis approached 10% in some centers; at present,
with greater operator experience the rate of this dreaded complication
is now consistently less than 1%. The same should be expected of
Super-Saturated Oxygen delivery.

If one examines the outcome data of AMIHOT II with specific attention to
overall MACE rates, it is compelling that with the introduction of the
INCA catheter for direct intracoronary infusion of SSO (in
contradistinction to the older Tracker catheter), the access site
complication rates were virtually identical for the two arms of the
study (Control: 12.7%; SSO: 13.3%) with no meaningful statistical
differences noted.

On a very practical level, physicians treating AMI patients have had
only a single weapon in their armamentarium to salvage myocardium; door
to balloon time has been the sole arbiter of left ventricular salvage
acutely over the past several decades. Our all-too-heavy reliance on
this variable mandates newer, more innovative approaches.
Super-Saturated Oxygen delivery and the TherOx system provide an
effective, practical and easy-to-use methodology for accomplishing this
goal.

I hope that you find my views to be helpful. The Downstream System is an
important new technology which I believe does represent a substantial
clinical improvement. For the sake of our patients, I hope that Medicare
also recognizes the importance of the technology. Thank you for your
consideration.

Sincerely,

David G. Rizik, M.D., F.A.C.C., F.S.C.A.I.

Medical Director, Scottsdale Heart Group

Scottsdale, Arizona

Director of Interventional Cardiology

Scottsdale Healthcare Hospitals

Scottsdale, Arizona