Policy Center Archives - Heart Valve Voice US https://www.heartvalvevoice-us.org/category/policy-center/ Giving a voice to people with heart valve disease Thu, 16 Oct 2025 18:45:43 +0000 en-US hourly 1 https://wordpress.org/?v=6.9.1 https://www.heartvalvevoice-us.org/wp-content/uploads/2019/02/cropped-Favicon-32x32.png Policy Center Archives - Heart Valve Voice US https://www.heartvalvevoice-us.org/category/policy-center/ 32 32 HVD Policy Task Force Comments on Section 232 Investigation on Imports of Personal Protective Equipment (PPE), Medical Consumables and Medical Equipment https://www.heartvalvevoice-us.org/hvd-policy-task-force-comments-on-section-232-investigation-on-imports-of-personal-protective-equipment-ppe-medical-consumables-and-medical-equipment/ Thu, 16 Oct 2025 18:45:43 +0000 https://www.heartvalvevoice-us.org/?p=12036 Dear Secretary Lutnick and Members of the Bureau of Industry and Security: As members of the Heart Valve Disease Policy Task Force, a national group of 30 leaders including clinician and patient advocates, we appreciate the opportunity to comment on the Department’s investigation into the national security implications of medical product imports under Section 232 […]

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]]> HVD Policy Task Force Comments on CMS’s Proposed National Coverage Decision for T-TEER https://www.heartvalvevoice-us.org/hvd-policy-task-force-comments-on-cmss-proposed-national-coverage-decision-for-t-teer/ Mon, 12 May 2025 19:54:40 +0000 https://www.heartvalvevoice-us.org/?p=11949 Dear Administrator Oz, As members of the Heart Valve Disease Policy Task Force, a national group of 30 leaders including clinician and patient advocacy organizations, we appreciate the opportunity to comment on CMS’s proposed NCD regarding Tricuspid Valve Transcatheter Edge-to-Edge Repair (T-TEER), also known as the TriClip G4 System. We wish to emphasize the critical […]

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]]> HVV Disease Policy Task Force Paper https://www.heartvalvevoice-us.org/hvv-disease-policy-task-force-paper/ Sun, 12 Jan 2025 20:18:27 +0000 https://www.heartvalvevoice-us.org/?p=11955 Dear Administrator Brooks-LaSure, As members of the Heart Valve Disease Policy Task Force, a national group of 30 leaders including clinician and patient advocates, we appreciate the opportunity to comment on the proposed decision memo for national coverage for Transcatheter Tricuspid Valve Replacement (TTVR). In particular, we wish to emphasize the critical importance of establishing […]

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]]> Heart Valve Disease Policy Task Force Submitted Letter to CMS Thanking the Opportunity to Comment on the NCA Tracking Sheet About the TriClip https://www.heartvalvevoice-us.org/heart-valve-disease-policy-task-force-submitted-letter-to-cms-thanking-the-opportunity-to-comment-on-the-nca-tracking-sheet-about-the-triclip/ Tue, 12 Nov 2024 20:06:04 +0000 https://www.heartvalvevoice-us.org/?p=11953 Dear Administrator Brooks-LaSure, As members of the Heart Valve Disease Policy Task Force, a national group of 30 leaders including clinician and patient advocacy organizations, we appreciate the opportunity to respond to the CMS NCD Tracking Sheet regarding Tricuspid Valve Transcatheter Edge-to-Edge Repair (T-TEER), also known as the TriClip G4 System. Expanding Medicare coverage to […]

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]]> Comment on CMS Coverage Policy for Transcatheter Tricuspid Valve Repair – TTVR https://www.heartvalvevoice-us.org/comment-on-cms-coverage-policy-for-transcatheter-tricuspid-valve-repair-ttvr/ Wed, 24 Jul 2024 17:28:31 +0000 https://www.heartvalvevoice-us.org/?p=11683 Dear Administrator Brooks-LaSure, As members of the Heart Valve Disease Policy Task Force, a national group of 30 leaders including clinician and patient advocates, we appreciate the opportunity to comment on the NCD Tracking Sheet regarding the Transcatheter Tricuspid Valve Replacement (TTVR) and want to emphasize the critical importance of establishing a comprehensive Medicare coverage […]

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]]> HVV-US Joins 28 Organizations on Letter to Administration about CED Language in White House Initiative https://www.heartvalvevoice-us.org/hvv-us-signs-on-letter-to-administration-about-ced-language-in-white-house-initiative/ Fri, 14 Jun 2024 22:37:22 +0000 https://www.heartvalvevoice-us.org/?p=11575 Heart Valve Voice US joined Society for Women’s Health Research and 27 organizations on letter to the Centers for Medicare & Medicaid Services Administrator Brooks-LaSure and White House Initiative on Women’s Health Research Chair Dr. Carolyn Mazure sharing concerns with CMS’ commitment, as outlined in the March 18 Executive Order on Advancing Women’s Health Research […]

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]]> HVD Policy Task Force Comments on FDA’s Review of the PMA for the TriClip G4 System https://www.heartvalvevoice-us.org/hvd-policy-task-force-comments-on-fdas-review-of-the-pma-for-the-triclip-g4-system/ Wed, 07 Feb 2024 22:38:43 +0000 https://www.heartvalvevoice-us.org/?p=11503 Dear Dr. Awojope and members of the Circulatory System Devices Panel of the Medical Devices Advisory Committee, While signatories to this public comment letter do not take a position on the merits of the premarket approval application (PMA) for the TriClip G4 System, we write to urge the Advisory Committee to consider the perspectives of […]

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]]> HVD Policy Task Force Comments on MCIT Repeal https://www.heartvalvevoice-us.org/medicare-coverage-of-innovative-technology-rule/ Mon, 18 Oct 2021 17:59:09 +0000 https://www.heartvalvevoice-us.org/?p=11018 Dear Administrator Brooks-LaSure: Heart Valve Voice US is submitting these comments on behalf of the Heart Valve Disease PolicyTask Force, which we chair. One in eight people over age 75 suffers from moderate to severeheart valve disease, placing a serious health burden on older Americans. As advocatesfor thesepatients, we are dismayed and disappointed in the […]

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]]> Comments on Cures 2.0 Discussion Draft https://www.heartvalvevoice-us.org/comments-on-cures-2-0-discussion-draft/ Mon, 26 Jul 2021 18:54:06 +0000 https://www.heartvalvevoice-us.org/?p=10971 Honorable Diana DeGetteHonorable Fred Upton Comments on Cures 2.0 Discussion Draft Dear Representatives DeGette and Upton: Thank you for your continued bi-partisan efforts to advance medical innovation benefittingpatients. Heart Valve Voice US is a nonprofit patient advocacy organization providing a unitedvoice for people living with heart valve disease. We advocate for early detection, meaningfulsupport, and […]

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]]> Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”; Delay of Effective Date (Docket No. CMS-2021-05490) https://www.heartvalvevoice-us.org/medicare-program-medicare-coverage-of-innovative-technology-mcit-and-definition-of-reasonable-and-necessary-delay-of-effective-date-docket-no-cms-2021-05490/ Tue, 20 Apr 2021 21:12:00 +0000 https://www.heartvalvevoice-us.org/?p=10886 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 patientshave access to safe, innovative new technologies – “Breakthrough Devices” – as soonas possible after receiving market authorization from the Food and Drug Administration. While we understand the rationale behind delaying […]

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