Dear Administrator Brooks-LaSure:
Heart Valve Voice US is submitting these comments on behalf of the Heart Valve Disease Policy
Task Force, which we chair. One in eight people over age 75 suffers from moderate to severe
heart valve disease, placing a serious health burden on older Americans. As advocatesfor these
patients, we are dismayed and disappointed in the repeal of Medicare Coverage of Innovative
While there are elements of the MCIT rule we would like to see improved, on balance we believe
it would serve the best interests of Medicare beneficiaries in need of innovative treatments for
heart valve disease. For many heart valve disease patients, time is of the essence and waiting 9-
12 months or more for a new technology to work its way through a current coverage pathway
might literally be a matter of life or death.
For many decades, if a heart valve needed to be repaired or replaced, the only option was open
heart surgery. This procedure is highly invasive, traumatic on the body, requires multiple days in
the hospital, and a six-month recovery period. About 10 years ago, we saw the advent of
transcatheter aortic valve replacement procedures, TAVR or TAVI, where the valve is inserted
by a catheter through the patient’s groin or shoulder. The whole procedure may be completed in
45 minutes and during the Covid-19 pandemic we saw these procedures being done on an
outpatient basis. These are truly “breakthrough” technologies and there are many more in the
pipeline. There are no drug therapies for heart valve disease. This is why automatic coverage of
breakthrough technologies upon approval by the Food and Drug Administration is so important.
We would prefer that CMS implement the MCIT rule as scheduled and propose future
modifications to address any deficiencies. This approach, we believe, would be in the best
interest of patients while also supporting continued medical innovation. Short of this, we implore
CMS to propose a new MCIT rule, or a rule meeting the same objective, as soon as practicable.
We understand that CMS is concerned that the clinical trials conducted under the FDA’s
Breakthrough designation might not always provide evidence that is relevant to the Medicare
population. In the case of heart valve disease, however, clinical trials are very representative of
the Medicare population. For example, in the pivotal trial for the first transcatheter aortic valve
replacement (TAVR) device, 80 percent of the patients were over 75 years of age. More than
half of symptomatic patients with severe aortic stenosis die within two years of diagnosis.
More recently, in the pivotal trial for the MitraClip™ mitral valve repair device, the average age
of clinical trial participants was 72. Mitral valve disease affects nearly 10 percent of people over
As such, we believe there would have been sufficient data to support a coverage decision in an
MCIT scenario for these two technologies, and they are representative of additional technologies
in the approval pipeline. Clinical trials for other serious medical conditions may not have a
similar age profile but perhaps CMS should consider the specific evidence used to gain a
Breakthrough approval rather than presuming the evidence to be inadequate. Where a
breakthrough technology demonstrates clear evidence of benefit to a Medicare population, CMS
should act to provide immediate coverage upon FDA approval.
CMS requests comment on whether existing pathways could accommodate MCIT-like objectives
of automatic coverage upon FDA approval. We encourage CMS to work with the FDA to
evaluate pathways to enable CMS’ Coverage and Access Group to begin assessing interventions
that have a high probability of receiving FDA approval, before an approval is formally given.
Coverage delays of one to two years after CMS approval have real impacts on the health of
beneficiaries. Enabling and providing staff capacity to support Parallel Review processeswould
better serve the objective of CMS, FDA, Medicare beneficiaries, and industry.
One of the shortcomings of the MCIT rule is a lack of any mandatory evidence gathering.
Through better coordination, CMS and FDA could work with manufacturers to establish ongoing
evidence collection programs to meet the dual objectives of post-market studies and evidence
development supporting coverage. This would require early and frequent engagement among
CMS, FDA and manufacturers to align on required evidence for approval and coverage. Under
this scenario, compliance would likely increase as well. We believe that the MCIT proposal
combined with some of the elements of the Parallel Review program would allow for greater
access without compromising the mandatory data collection required under existing approval
As patient advocates, we absolutely support ongoing data gathering to ensure technologies are
safe, effective, and serve the best interests of Medicare beneficiaries. This mandatory data
collection should be of real-world evidence through a new or existing data registry, such as the
STS/ACC Transcatheter Valve Therapy (TVT) Registry (in the case of heart valve technologies), electronic health records, patient-reported outcomes, or other similar mechanisms. This reconsideration of MCIT also provides an opportune time for CMS to weigh the incorporation of patient preference studies into coverage decisions as supplemental evidence while real-world
evidence is gathered.
Likewise, we support CMS’ ability to have discretion over removing coverage of a device should
it not meet the needs of Medicare beneficiaries.
Regarding the “Reasonable & Necessary” provisions of the rule, we recommend CMS consider
this issue separately. When the issue is reconsidered, we feelstrongly that any codified definition
of “reasonable and necessary” include consideration of patient preferences. We are in an era of
patient-focused medical product development and patient-centered research and care. The patient
perspective must be incorporated into the coverage paradigm, as well. This would entail CMS
establishing criteria for the consideration of patient perspectives and incorporation into coverage
While we disagree with the decision to repeal the MCIT rule, we appreciate your thoughtful
consideration of these issues and your focus on advancing policies that are in the best interest of
Medicare beneficiaries. Certainty of coverage of innovative technologies is of utmost importance
to the patients we represent, most of whom are of Medicare age. If you would have any
questions, please do not hesitate to contact John Lewis at email@example.com or 202-
285-5726. Thank you for your consideration.
Alliance for Aging Research
Association of Black Cardiologists
Heart Valve Voice US
Read the full comment letter here.