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View Public Comments for Artificial Hearts and related devices, including Ventricular Assist Devices for Bridge-to-Transplant and Destination Therapy (CAG-00453N)

Commenter:
Harrington, M.D., FAHA, Robert A.
Title:
President
Organization:
American Heart Association (AHA)
Date:
03/02/2020
Comment:

March 4, 2020

Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: CAG-00453N

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 patientfs 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 determinations.

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.

Sincerely,

/s/
Robert A. Harrington, M.D., FAHA
President

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