American Heart Association (AHA)
March 4, 2020
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244
To whom it may concern,
On behalf of the American Heart Association (AHA), including the
American Stroke Association (ASA) and more than 40 million
volunteers and supporters, we appreciate the opportunity to submit
our comments in response to the National Coverage Analysis (NCA)
for Artificial Hearts and related devices, including
Ventricular Assist Devices (VAD) for Bridge-to-Transplant (BTT) and
Destination Therapy (DT).
Due to the limited number of donor hearts and the long waiting
times, cardiac transplantation is only available to a very small
percentage of patients, and medical therapy alone does not suffice
for many patients. The AHA has long recognized that implantation
of mechanical circulatory support (MCS) is an important
therapeutic option for individuals with life]threatening advanced
heart failure despite optimal medical and device therapy. In the
appropriate patient population, MCS implantation has been shown
to improve survival, quality-of]life and functional status.
Recognizing the importance of MCS, the AHA supports these
reconsideration requests and offers the following in response to the
request for comments:
Total Artificial Heart (TAH) for Use as a Bridge-To-Transplant
Under existing rules, artificial hearts are covered under the Coverage with
Evidence Development (CED) designation on the condition that they are
furnished in the context of approved clinical studies or with the collection
of additional clinical data. Patients with biventricular failure,
unrepairable ventricular septal defects, infiltrative or hypertrophic
cardiomyopathy phenotypes, etc., have inordinately poor survival and no
conventional MCS options other than a TAH. There is currently only one
device available that can save the lives of these patients.
There is an extensive body of evidence presented in the reconsideration
request that shows that the TAH is a safe and effective therapeutic option.
Furthermore, there is currently no other viable alternative in existence
that has been approved by the US Food and Drug Administration (FDA).
Therefore, the AHA agrees that TAH availability should not be restricted to
clinical trial settings, and the CED stipulation should be removed so that
the device may be implanted by experienced centers with the purpose of
bridging patients to potential cardiac transplantation.
Ventricular Assist Devices (VAD)
Currently, there are 2 accepted indications for implantation of a durable
LVAD that are recognized by the FDA and for which there are
reimbursement criteria set by the Centers for Medicare & Medicaid
Services (CMS); BTT and DT. The intention of the patientfs LVAD
treatment, whether it be BTT or DT, currently plays into coverage
determinations and is often assigned prior to device implantation.
However, there is significant clinical uncertainty as to which patients will
ultimately become eligible for cardiac transplantation as compared to
those who will not. Despite the requirement that intent to treat be
considered in coverage determinations, outcomes show, and it is clear
from the literature (including MOMENTUM 3), that LVAD therapy
demonstrates that both cohorts benefit from long-term VAD support with
excellent survival, low complication rates and acceptable cost-effectiveness.
As such, the stipulation of differentiating BTT and DT prior to implantation
is clinically irrelevant, practically obsolete and creates an administrative
burden for clinicians as well as CMS that should be eliminated.
Accordingly, the AHA supports this reconsideration request and urges
CMS to remove the intent to treat criteria from patient coverage
Thank you for consideration of our comments. If you have any questions
or require any additional information, please contact Tyler Hoblitzell of
AHA staff at (202) 785-7901 or Tyler.Hoblitzell@heart.org.
Robert A. Harrington, M.D., FAHA