Knowledge Base Article

In a June 30th Press Release, CMS proposed to update National Coverage Determination (NCD) 20.33 noting that currently the NCD covers the transcatheter procedure for patients with symptomatic degenerative mitral regurgitation (MR). Before we take an in depth look at the changes in the Proposed Decision Memo (CAG-00438R), I want to provide relevant background information about the Transcatheter Mitral Valve Repair (TMVR) procedure.

Background

August 2014

The current NCD has been effective since August 7, 2014. Per the related 2014 Decision Memo, the FDA approved the first TMVR device.

Abbott Vascular’s MitraClip® was approved “for the percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.”

Abbott Vascular’s MitraClip® is currently the only FDA-approved TMVR device. The procedure involves clipping together a portion of the mitral valve leaflets as a treatment for reducing MR to improve recovery of the heart from overwork, improve function and potentially halt the progression of heart failure.

August 2019

At the request of the Society of Thoracic Surgeons (STS), the American College of Cardiology (ACC), the American Association for Thoracic Surgery (AATS), and the Society for Cardiovascular Angiography & Interventions (SCAI), CMS opened a National Coverage Analysis (NCA) Tracking Sheet for Transcatheter Mitral Valve Repair (TMVR) (CAG-00438R). The expected release of a Proposed Decision Memo was to have been February 14, 2020.

National Coverage Analysis Issue

 TMVR is used in the treatment of mitral regurgitation (MR). There are two types of MR.

• Primary (degenerative) MR results from structural failure of mitral valve, and
• Secondary (functional) MR results from left ventricular (LV) dysfunction with a largely preserved mitral valve.

Currently, the NCD establishes coverage for the treatment of significant symptomatic Primary MR. The national tracking analysis focused on TMVR for the treatment of significant symptomatic Secondary MR.

June 30, 2020 Proposed Decision Memo for TMVR (CAG-00438R)

TMVR to TEER

CMS opens the Decision Summary by indicating they are replacing the acronym TMVR with TEER (Transcatheter Edge-to-Edge Repair) “to more precisely define the treatment addressed in this proposed NCD, which is applicable to TEER for the treatment of functional mitral regurgitation (MR) and degenerative MR.”

From Coverage for Primary (Degenerative) MR to Coverage for Secondary (Functional) MR

CMS notes that “Cardiac surgery for secondary MR has been shown to improve symptoms but not survival…However, recent evidence reviewed here demonstrates that TEER may improve symptoms, quality of life, and survival of appropriately selected patients with secondary MR.”

CMS has removed Primary (degenerative) MR as an indication for the TEER procedure noting that coverage determinations for on-labeled uses of FDA approved devices for this group of patients will be made by Medicare Administrative Contractors (MACs).

The NCD will now provide coverage indications for the TEER procedure for patients with Secondary (functional) MR.

Coverage with Evidence Development (CED) Requirement Removed from NCD

Currently TMVR is non-covered for the treatment of MR when not furnished under CED. This is no longer a requirement in the Proposed Decision Memo.

Shared-Decision Making

“CMS recognizes the importance of shared decision-making (SDM) in many clinical scenarios and has required SDM in other NCDs (for example, implantable cardiac defibrillators: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=110). 

CMS supports patient SDM in TEER but there is no fully developed tool available at this time.  CMS strongly encourages standardized decision aids or tools [the National Quality Forum (NQF) has published standards for decision aids (www.qualityforum.org/Projects/c-d/Decision_Aids/Final_Report.aspx)] to facilitate the decision making process between a patient and physician and will be monitoring this space closely. 

Tools are in development for other conditions and procedures.  For example, the Patient-Centered Outcomes Research Institute (PCORI) funded research (CER-1306-04350/ NCT02266251), to create and assess a personalized decision assistance tool designed to evaluate important health outcomes between SAVR to TAVR for operable patients with aortic valve disease considering aortic valve replacement.  The work also aims to develop and assess a personalized risk assessment tool designed to evaluate expected health outcomes with TAVR for inoperable patients considering aortic valve replacement.”

Proposed Coverage Requirements for TEER Procedure

1. TEER for mitral valve would be covered as follows:
2. When performed to treat symptomatic moderate-to-severe or severe Functional MR when the patient remains symptomatic despite stable doses of maximally tolerated guideline-directed medical therapy (GDMT).

Guideline Directed Medical Treatment (GDMT)

“The specialty societies publish detailed guidelines for the diagnosis and management of heart failure.  The most recent full guideline was published in 2013, with a focused update in 2016. In addition to lifestyle changes, cornerstones of pharmacologic treatment of systolic heart failure include angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARB), angiotensin receptor-neprilysin inhibitors (ARNI), beta-blockers, mineralocorticoid antagonists (MRA), and diuretics.  For eligible patients, implantable cardiac defibrillators (ICD) can improve survival, while cardiac resynchronization therapy (CRT) can improve symptoms, reduce MR, reduce hospitalizations, and increase survival.”

• Eligible patients must also meet the following criteria:
• Ischemic or non-ischemic cardiomyopathy; and
• Left ventricular ejection fraction of 20 to 50%; and
• New Your Heart Association Functional Class II, III, or Iva (ambulatory); and
• Left ventricular end-systolic dimension ≤ 70mm; and
• Local heart team has determined that mitral valve surgery will not be offered as a treatment option.

FDA Expansion of Approved Indications for MitraClipNote™

 The FDA expanded the approved indications for MitraClip™ on March 14, 2019. The proposed coverage requirements above align with the FDA’s expanded indications.

• Procedure must be furnished according to FDA-approved indication and meet the following conditions:
• All requirements set for in 2a through 2c; and
• The patient is under the care of a heart failure specialist experienced in the care and treatment of mitral valve disease; and
• The heart team also included a heart failure physician specialist experienced in the care and treatment of mitral valve disease; and
• The heart team cardiac surgeon and interventional cardiologist have:
• Independently examined the patient face-to-face, evaluated the patient’s suitability for surgical mitral valve repair, TEER, maximally tolerated GDMT, or palliative therapy; and
• Documented and made available to the other heart team members the rationale for their clinical judgment.

Face-to-Face Examination during COVID-19 Public Health Emergency (PHE)

Per the Proposed Decision Memo, “In the interim final rule with comment period [CMS-1744-IFC], CMS finalized that to the extent an NCD or LCD would otherwise require a face-to-face or in-person encounter for evaluations, assessments, certifications or other implied face-to-face services those requirements would not apply during the public health emergency (PHE) for the COVID-19 pandemic.  This would include the proposed face-to-face examination by the heart team cardiac surgeon and interventional cardiologist.”

2. Requirements in this section apply to TEER for Functional MR as specific in section 1.
3. The patient (pre-op and post-op) is under the care of a heart team that must include:
4. Cardiac surgeon; and
5. Interventional cardiologist; and
6. Interventional echocardiographer; and
7. Providers from other physician groups as well as advanced patient practitioners, nurses, research personal and administrators.
8. The interventional cardiologist or cardiac surgeon must perform the mitral valve TEER. They may jointly participate in the intra-operative technical aspects of TEER as appropriate.
9. Mitral valve TEERs must be performed in hospitals with appropriate infrastructure including but not limited to:
10. On-site heart valve surgery and interventional cardiology programs,
11. Post-procedure intensive care facility with personnel experienced in managing patients who have undergone open-heart valve procedures,
12. Appropriate volume requirements.

Appropriate Volume Requirements

There are two sets of qualifications for appropriate volume requirements (qualifications to begin a mitral valve TEER program and qualifications for mitral valve TEER experience). CMS is proposing “to modify this requirement consistent with the same requirement for the interventional cardiologist as set forth in the June 2019 TAVR NCD Decision Memo. While clinically appropriate, this modification also establishes consistency across valve program areas.”

Proposed Reasons for TEER to Not Be Covered for the treatment of functional MR

1. Coexisting aortic or tricuspid valve disease requiring surgery or transcatheter intervention; or
2. COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use; or
3. ACC/AHA Stage D heart failure; or
4. Estimated pulmonary artery systolic pressure (PASP) > 70 mmHg as assessed by echocardiography or right heart catheterization, unless active vasodilator therapy in the catheterization laboratory is able to reduce the pulmonary vascular resistance (PVR) to < 3 Wood Units or between 3 and 4.5 Wood Units with a v wave less than twice the mean of the pulmonary capillary wedge pressure (PCWP); or
5. Hemodynamic instability requiring inotropic support or mechanical heart assistance; or
6. Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction; or
7. Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.

TEER of the mitral valve for the treatment of functional MR is not covered for patients in whom existing co-morbidities would preclude the expected benefit from correction of the mitral valve.

Optimal Patient Selection for TEER

CMS acknowledges that there are limitations in the trial/study evidence available to assist the heart team in optimal patient selection for TEER. They note in the proposed Decision Memo that they will carefully monitor treated patients for adherence to the criteria and will assess patient outcomes over the next four years through evidence published in the peer reviewed literature. At that time, contingent upon real-world demonstration of outcomes consistent with those achieved in the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (The COAPT Trial), they will consider modifying criteria.

CMS is seeking comments on the proposed national coverage determination. A final decision will be issued no later than 60 days after the conclusion of the 30-day public comment period. I strongly encourage those involved in providing this service to read the proposed decision.