Heart Valve Disease Policy Task Force
The Heart Valve Disease Policy Task Force is a coalition of organizations advocating for policy solutions that improve access, research, and awareness on heart valve disease detection and treatment.
To learn more about the Task Force and to join, contact Lindsay Clarke at [email protected]
TMVR National Coverage Determination
In August 2019, the Centers for Medicare and Medicaid (CMS) initiated a national coverage analysis (NCA) for transcatheter mitral valve repair (TMVR). The original National Coverage Determination from 2014 was established under Coverage with Evidence Development (CED) for treatment of significant symptomatic mitral regurgitation. In March 2019, the Food and Drug Administration expanded the indication for the MitraClip device to include heart failure patients who have moderate-to-severe or severe functional mitral regurgitation despite treatment with optimal medical therapy. A public comment period on the NCA was open from August 14, 2019 to September 13, 2019. A proposed decision memo is due by February 14, 2020, at which time there will be additional opportunities to comment.
- Learn more about the National Coverage Analysis here.
- Read the comments submitted from Heart Valve Disease Policy Task Force members here and a press statement about the comments here.
- Read an op-ed from the Alliance’s Sue Peschin on the coverage decision here.
- Learn more about TMVR watch video from the Capitol Hill Briefing hosted by Heart Valve Voice US.
TAVR National Coverage Determination
On June 27th, 2018 the Centers for Medicare and Medicaid (CMS) announced that they are reconsidering the National Coverage Determination (NCD) for transcatheter aortic valve replacement (TAVR). The current NCD lays out requirements for TAVR procedures used for the treatment of symptomatic aortic stenosis according to an FDA-approved indication. Reopening the NCD means that CMS is reexamining how TAVR will be covered and reimbursed moving forward. The new determination could impact access to TAVR—potentially widening or limiting the ability of patients to get TAVR.
Visit the Task Force NCD page to learn more about our advocacy priorities for the NCD and to access education and outreach materials.
The Heart Valve Disease Policy Task Force recognizes the value of shared decision-making and is invested in advancing models that achieve high-quality shared decision-making. A recent letter to CMS Administrator Seema Verma and CMS Director of the Center for Clinical Standards & Quality, Kate Goodrich, was signed by 42 organizations including some Task Force members. The letter urged CMS to establish clear guidance implementing the program to facilitate shared decision-making that is called for in statute. Read the letter here.
The Task Force is supported by unrestricted educational support from Edwards Lifesciences and Abbott.