News | Heart Valve Technology | January 20, 2021

Medicare Expands Coverage for MitraClip in Heart Failure Patients

New national reimbursement significantly expand access to transcatheter mitral valve repair procedures for secondary mitral regurgitation

A new CMS national coverage determination for reimbursement for MitraClip significantly expand access to transcatheter mitral valve repair procedures for secondary mitral regurgitation.

January 20, 2021 — The U.S. Centers for Medicare and Medicaid Services (CMS) revised its National Coverage Determination (NCD) to expand coverage for the Abbott MitraClip to include patients with secondary (or functional) mitral regurgitation (MR) resulting from heart failure.

The procedure is known as transcatheter edge-to-edge repair (TEER), but is also referred to as transcatheter mitral valve repair (TMVR).

The CMS decision significantly increases the number of people eligible for insurance coverage for mitral valve repair with MitraClip, enabling broader access to the device. As the first TEER device approved by the U.S. Food and Drug Administration (FDA) and reimbursed by Medicare for primary mitral regurgitation, physicians have increasingly relied on the therapy to improve survival and quality of life for their patients. Today's decision improves insurance coverage for people with secondary MR who need treatment with MitraClip.

"Secondary mitral regurgitation generally impacts older individuals suffering from heart failure who rely on Medicare for their healthcare coverage," said Neil Moat, M.D., chief medical officer of Abbott's structural heart business. "CMS' decision to expand coverage for MitraClip marks a pivotal moment for people seeking a minimally invasive option that reduces mitral regurgitation and significantly improves their quality of life and chances of survival."

Following MitraClip's original approval by the FDA in late 2013, CMS provided coverage for Medicare patients with primary (degenerative) mitral regurgitation who needed treatment with MitraClip. Similarly, this revised NCD comes after the FDA's 2019 expanded indication for MitraClip to treat people with secondary MR. 

Read the CMS NCD

MitraClip Clinical Data Continues To Improve

The decision also follows the highest MR reduction data for MitraClip reported to date. Recent 2020 data demonstrated MR reduction was consistently achieved with MitraClip in patients with either primary MR (to ≤1+ in 87.1%) or secondary MR (to ≤1+ in 90.1%) at 30 days.[1]

Abbott said the device is supported by more than 17 years of clinical trial data demonstrating safety and efficacy, and it is now on the fourth generation of product innovations. MitraClip is a first-of-its-kind device that clips together the mitral valve leaflets to reduce the backflow of blood and restore the heart's ability to pump oxygenated blood efficiently. The device provides symptom relief for both primary and secondary MR, with most patients being released from the hospital, on average, two days post-procedure.[2]

Heart Failure Causes Enlargement of the Heart Leading to MR

People with heart failure are at risk of developing significant secondary MR, a serious and progressive heart disease in which the two chambers of the left side of the heart become enlarged. This causes thus preventing the mitral leaflets from closing normally and allowing blood to flow backwards through the heart. This can lead to reduced quality of life, recurrent hospitalizations and decreased survival.[3,4,5] Most heart failure patients with clinically significant secondary MR are treated with medication only, but data shows that these patients can benefit from reduction in MR with MitraClip. 

Abbott said this NCD revision is critically important to secondary MR patients, as most of those impacted by MR are older, with one in 10 adults age 75 or older experiencing MR,[6]  and therefore relying on Medicare for their health insurance. Medicare coverage is limited to treatments, procedures and other healthcare items or services that CMS considers reasonable and necessary. National Coverage Determinations mandate coverage at the national level for all Medicare beneficiaries, including those participating in Medicare Advantage plans. 

Had CMS not revised the NCD to include the new secondary MR indication, Medicare patients with the secondary form of the disease would have continued to be ineligible for coverage and required to pay out of pocket for the procedure, creating a barrier to therapy access for patients.

 

About the MitraClip Device

MitraClip is now approved in more than 75 countries worldwide.

The MitraClip system has been commercially available in Europe since 2008 and was approved in the U.S. in 2013 for primary MR patients. In March 2019, the FDA approved MitraClip for secondary MR patients based on results from the landmark COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) Trial,[7] which investigated MitraClip for treating secondary MR. COAPT showed a 47 percent relative reduction in hospitalizations and a 38 percent relative reduction in mortality for secondary MR patients. Both primary and secondary MR patients may benefit from MitraClip therapy based on this expanded indication for MitraClip.

For more information on MitraClip: www.MitraClip.com

For U.S. safety information on MitraClip: http://abbo.tt/MitraClipG4ISI

 

  
References:

1. Rottbauer W. D. Contemporary Clinical Outcomes with MitraClip (NTR/XTR) System: Core-lab Echo Results from +1000 Patient the Global EXPAND Study. Data presented at PCR 2020.

2. Sorajja, P, et al. Outcomes with Transcatheter Mitral Valve Repair in the United States. J Am Coll Cardiol. 2017;70(19):2315-2327. DOI: 10.1016/j.jacc.2017.09.015.

3. Asgar AW, Mack MJ, Stone GW. Secondary mitral regurgitation in heart failure: pathophysiology, prognosis, and therapeutic considerations. J Am Coll Cardiol 2015;65:1231-48.

4. Sannino A, Smith II RL, Schiattarrella GG, et al. Survival and cardiovascular outcomes of patients with secondary mitral regurgitation: a meta-analysis of 53 studies. JAMA Cardiology 2017; 2:1130-39.

5. Goliasch G, Bartko PE, Pavo N, et al. Refining the prognosis impact of functional mitral regurgitation in chronic heart failure. Eur Heart J 2018;39:39-46.

6. Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006;368(9540):1005-1011.

7. Stone GW, Lindenfeld JA, Abraham WT, et al., on behalf of the COAPT Investigators. Transcatheter Mitral-Valve Repair in Patients With Heart Failure. N Engl J Med 2018;379:2307-18.

Related Content

Medtronic is recalling its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology, which are transcatheter devices used to seal brain aneurysms. The company said there is a risk of the delivery system’s wire and tubes fracturing and breaking off when the system is being used to place, retrieve, or move the stent inside a patient.
News | Cath Lab | September 21, 2021
September 21, 2021 — Medtronic is recalling its Pipeline Flex Embolization Device and Pipeline Flex Embolization Devi
Feature | Cath Lab | September 14, 2021 | By Aaron Detate and Lars Thording
In the electrophysiology (EP) lab, hundreds
An example of the Medis QCA angiography imaging derived fractional flow reserve (FFR) assessment. This technology removes the need for pressure wires and adenosine used in traditional FFR assessments of the coronary arteries.

An example of the Medis QCA angiography imaging derived fractional flow reserve (FFR) assessment. This technology removes the need for pressure wires and adenosine used in traditional FFR assessments of the coronary arteries.

News | Cath Lab | July 22, 2021
July 22, 2021 — Medis Medical Imaging is partnering with CORRIB Core Lab and Sinomed in randomized clinical trial of
ast End Medical announced it received U.S. Food and Drug Administration (FDA) clearance for the company's SafeCross Transseptal Radiofrequency (RF) Puncture and Steerable Balloon Introducer System. The 3-in-1 system, which includes a steerable introducer sheath with an ultra-visible positioning balloon and radiofrequency (RF) puncture dilator, aims to provide a predictable and safe solution for electrophysiology (EP) and structural heart interventions requiring left atrial access.
News | Cath Lab | July 14, 2021
July 13, 2021 — East End Medical announced it received U.S.
There is a trend in interventional cardiology that is now being called “renalism,” where patients with poor renal function are being excluded from interventional procedures because they are automatically considered too high risk. However, some hospitals are also creating cardio-renal care teams so these patients can be cared for by a team of experts rather than interventional cardiologists going it alone. #SCAI21 #SCAI2021 Creating a card0-renal program.

There is a trend in interventional cardiology that is now being called “renalism,” where patients with poor renal function are being excluded from interventional procedures because they are automatically considered too high risk. However, some hospitals are also creating cardio-renal care teams so these patients can be cared for by a team of experts rather than interventional cardiologists going it alone.

Feature | Cath Lab | May 14, 2021 | By Dave Fornell, Editor
There is a trend in interventional cardiology that is now being called “renalism,” where patients with poor renal fun
Abbott recently announced its new interventional imaging platform powered by Ultreon 1.0 Software, has gained European CE marked. This first-of-its-kind imaging software merges optical coherence tomography (OCT) intravascular imaging with the power of artificial intelligence (AI) for enhanced visualization. The new Ultreon Software can automatically detect the severity of calcium-based blockages and measure vessel diameter to enhance the precision of physicians’ decision-making during coronary stenting proc

Abbott recently announced its new interventional imaging platform powered by Ultreon 1.0 Software, has gained European CE marked. This first-of-its-kind imaging software merges optical coherence tomography (OCT) intravascular imaging with the power of artificial intelligence (AI) for enhanced visualization. The new Ultreon Software can automatically detect the severity of calcium-based blockages and measure vessel diameter to enhance the precision of physicians’ decision-making during coronary stenting procedures.

News | Cath Lab | May 12, 2021
May 12, 2021 — Abbott recently announced its new interventional imaging platform powered by Ultreon 1.0 Software, has
SCAI 2021 late-breaking presentations included the data on the Medtronic Harmony transcatheter pulmonary valve, cutting radial access hemostasis time by 50 percent, improving cardiogenic shock survival to 71 percent, and data showing very high mortality in COVID patients who suffer a STEMI heart attack. #SCAI21 #SCAI2021

SCAI 2021 late-breaking presentations included the data on the Medtronic Harmony transcatheter pulmonary valve, cutting radial access hemostasis time by 50 percent, improving cardiogenic shock survival to 71 percent, and data showing very high mortality in COVID patients who suffer a STEMI.

Feature | Cath Lab | May 06, 2021 | By Dave Fornell, Editor
April 29, 2021 — Here is the list of late-breaking study presentations and links to articles about each of them from
Most Stable Ischemic Heart Disease Patients Did Not Meet ISCHEMIA Trial Enrollment Criteria, raising questions about its application in real-world practice. #SCAI2021 Getty Images

Getty Images

News | Cath Lab | May 03, 2021
May 3, 2021 – Results from a new study find a broad range of patients who typically undergo revascularization for sta
New study demonstrates depression, HIV, mental health, obesity, alcohol and drug abuse are risk factors on most common type of heart disease in young black patients. Photo by Dave Fornell
News | Cath Lab | April 29, 2021
April 29, 2021 – A retrospective analysis of risk factors for coronary artery disease (CAD) in young African American