The Heart Valve Disease Policy Task Force represents a diverse group of patient,
disease, and research advocacy groups with a shared interest of ensuring that patients
have access to safe, innovative new technologies – “Breakthrough Devices” – as soon
as possible after receiving market authorization from the Food and Drug Administration.
While we understand the rationale behind delaying the effective date of the MCIT final
rule, and appreciate the opportunity to comment, we strongly request that its
implementation be delayed no longer than May 15, 2021. Only swift implementation will
provide Medicare beneficiaries with the certainty of coverage and choice of care they
deserve.
The overall pros of the adoption of MCIT far outweigh whatever cons are contained in
the final rule. We believe any shortcomings of the rule can be addressed subsequently
though the sub-rulemaking process and issuance of guidance documents. This is
clearly a case, to paraphrase Voltaire, where the perfect should not be the enemy of the
good.
