Effective Now: Medicare Coverage for Functional MR Patients

On January 19, 2021, the Centers for Medicare and Medicare Services (CMS) released the Final NCD that expands coverage to patients for the treatment of functional/secondary mitral regurgitation (MR) using Transcatheter Edge-to-Edge Repair (TEER). This policy is effective immediately for all hospital discharges from January 19th onward.

Great news! CMS has expanded coverage for patients with significant symptomatic functional MR. To view a webinar that covers the changes in the Final NCD 20.33, please click here.

The current indication for MitraClip™ for functional MR is:

  • The MitraClip™ G4 System, when used with maximally tolerated guideline-directed medical therapy (GDMT), is indicated for the treatment of symptomatic, moderate-to-severe or severe secondary (or functional) mitral regurgitation (MR; MR ≥ Grade III per American Society of Echocardiography criteria) in patients with a left ventricular ejection fraction (LVEF) ≥ 20% and ≤ 50%, and a left ventricular end systolic dimension (LVESD) ≤ 70 mm whose symptoms and MR severity persist despite maximally tolerated GDMT as determined by a multidisciplinary heart team experienced in the evaluation and treatment of heart failure and mitral valve disease.

The table below provides a summary of the coverage criteria and requirements for MR patients. For a complete list of coverage criteria, please click to view the Final NCD.

Item NCD 20.33 Criteria/Requirements1
Coverage Pathway TEER with MitraClip™ is covered under Coverage with Evidence Development (CED) and Registry participation is required.
Covered Population For the treatment of symptomatic moderate-to-severe or severe functional mitral regurgitation (MR) when the patient remains symptomatic despite stable doses of maximally tolerated guideline-directed medical therapy (GDMT) plus cardiac resynchronization therapy, if appropriate, or for the treatment of significant symptomatic degenerative MR when furnished according to an FDA-approved indication.
Required Patient Evaluations For patients with functional MR: Interventional Cardiologist and Heart Failure Cardiologist

For patients with degenerative MR: Interventional Cardiologist and Cardiac Surgeon
Coverage Exclusions Patients in whom existing co-morbidities would preclude the expected benefit from a mitral valve TEER procedure.

In patients with untreated severe aortic stenosis.
Heart Failure Cardiologist on the Heart Team Heart Failure Cardiologist must be experienced in the care and treatment of mitral valve disease. Board certification in Advanced Heart Failure and Transplant Cardiology not required.

The Final NCD has updated volume requirements for hospitals and operators. The tables below provide a summary of the criteria for all TEER sites.

Volume Requirements1 All TEER Sites
Hospitals
  • ≥20 annual mitral valve (MV) surgeries (or ≥40 over two years) (50% repair)
  • ≥300 annual PCIs
Interventional Cardiologists
  • ≥50 SH procedures lifetime OR ≥30 left-sided SH annual
  • ≥20 trans-septal interventions lifetime (10 as primary operator)
  • Board eligible or certified in interventional cardiology
Cardiac Surgeons
  • ≥20 annual mitral valve surgeries (or ≥ 40 over the past two years) including 50% repair
  • Board eligible or certified in cardiothoracic surgery or similar foreign equivalent
Imagers
  • ≥10 trans-septal guidance procedures and ≥30 SH procedures lifetime
  • Board eligible or certified in transesophageal echocardiography with advanced training as required for privileging by the hospital where the TEER is performed.

1 NCD 20.33 and Decision Memo CAG-00438R: Transcatheter Mitral Valve Repair

Note: CMS did not finalize any maintenance volume requirements for transcatheter mitral valve procedures

This policy is effective immediately for all hospital discharges that occur from January 19th onward and will take the place of the previous policy. If there are any questions related to the new Transcatheter Edge-to-Edge Repair NCD, please reach out to your local MitraClip sales representative or by selecting your preferred contact method under the Questions section to the right.

CMS Retains Coverage for Degenerative MR Patients in NCD

For the treatment of degenerative MR, coverage for TEER of the mitral valve on-labeled uses of FDA approved devices is retained in the NCD. The current indication for MitraClip™ in degenerative MR patients is as follows:

  • The MitraClip™ G4 System is indicated 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 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.

Please note, CMS uses the terms “degenerative” and “functional” throughout the NCD. Degenerative is also referred to as primary and functional is also referred to as secondary.