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 Michael Ward at [email protected]
TMVR/TEER National Coverage Determination
The Centers for Medicare and Medicaid Services (CMS) released the original National Coverage Determination (NCD) for transcatheter mitral valve repair (TMVR) in 2014. The original NCD 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. Following FDA’s revised list of indications for TMVR, CMS initiated a national coverage analysis (NCA) (TMVR) in August 2019. A public comment period on the NCA was open from August 14, 2019 to September 13, 2019.
CMS finalized the updated NCD for TMVR on January 19, 2021 and specified that the NCD applies to the transcatheter edge-to-edge repair (TEER) procedure. The updated NCD included several advances in coverage requested by the HVD Task Force, including coverage for TEER to patients with either degenerative and functional mitral regurgitation, standardized care team requirements, and support for ongoing registry data on TEER outcomes.
Resources on CMS National Coverage Analysis:
- CMS TMVR National Coverage Analysis homepage
- HVD Task Force comment letter
- Alliance press statement on HVD Task Force NCA comment letter
- Morning Consult op-ed on NCA from Sue Peschin, Alliance President and CEO
CMS released a proposed Medicare national coverage decision memo (NCD) on June 30, 2020. A public comment period on the NCD was open through July 30, 2020.
Resources on CMS TMVR proposed National Coverage Decision:
- CMS TMVR National Coverage Decision homepage
- HVD Task Force comment letter
- Alliance for Aging Research press statement on HVD Task Force proposed NCD comment letter
- Alliance for Aging Research statement on CMS’s release of proposed NCD
- Alliance for Aging Research press statement on finalized TEER National Coverage Decision
Learn more about TMVR by watching 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 TAVR NCD page to learn more about our advocacy actions on 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.