Medicare now covers transcatheter edge-to-edge repair (TEER)* in functional MITRAL REGURGITATION (FMR) patients
*TEER is also known as TMVr (transcatheter mitral valve repair)
Coverage Criteria Effective January 19, 2021
The new, finalized Medicare National Coverage Determination (NCD)1 for the treatment of functional mitral regurgitation (MR) is effective for all hospital discharges from January 19th onward. For additional questions, please reach out to the Reimbursement Hotline at ReimbursementHelp@Abbott.com.
Functional/Secondary MR Coverage
The tables below provide a summary of coverage for FMR patients. For a complete coverage criterion, please refer to NCD 20.33.
| Item | NCD 20.33 Criteria/Requirements1 |
|---|---|
| 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. |
| Coverage Pathway | TEER with MitraClip™ is covered under Coverage with Evidence Development (CED) and Registry participation is required. |
| 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. |
| Volume Requirements1 | All TEER Sites |
|---|---|
| Hospitals |
|
| Interventional Cardiologists |
|
| Cardiac Surgeons |
|
| Imagers |
|
Degenerative/Primary MR Coverage
For the treatment of degenerative MR, coverage for TEER of the mitral valve for on-labeled uses of FDA-approved devices is determined by Medicare Administrative Contractors (MACs). MACs may publish local coverage decisions for TEER; however, such activities would require a development process as outlined in the Medicare Program Integrity Manual, Chapter 13. Check with your local MAC for any preauthorization or coverage requirements.
MitraClip Transcatheter Mitral Valve Repair (TMVr): Private Payer and Medicare Advantage Information
Private Payers
Private payer plans vary significantly in coverage and compliance requirements for TMVr with the MitraClip therapy.
- Commercial payers should be consulted in advance of the procedure to verify terms and conditions of coverage
- Please check with your payer regarding appropriate coding and payment information
- Commercial payer payment methods for reimbursing inpatient services, including case rates, percent of billed charges, DRGs, and device carve-outs
- Commercial payer policies vary on details such as:
- Prior authorization requirements
- Co-surgeon requirements
- Covered disease etiology (primary/secondary MR)
- Individual case consideration/appeals process
Please consult the commercial payer directly to ensure complete understanding of any relevant coverage policies and billing requirements.
Medicare Advantage
Medicare Advantage plans must cover TMVr with the MitraClip therapy consistent with the NCD.
- Medicare Advantage plans may not impose more restrictive coverage criteria than detailed in the NCD
- Medicare Advantage plans may use prior authorization/pre-certification to ensure compliance with the NCD
Please reach out directly to Medicare Advantage plan administrators to understand any specific prior authorization/pre-certification requirements that may apply.
Contact Information
Abbott is committed to supporting appropriate patient access to the MitraClip therapy and educating providers on the latest coverage, coding, and payment policy.
For additional questions, please contact:
Reimbursement Hotline: 800-354-9997
ReimbursementHelp@Abbott.com
MAT-2106016 V2.0 | Item approved for U.S. use only
- National Coverage Determination 20.33: www.cms.gov/medicare-coverage-database/details/ncd-details.aspx.
- Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program. www.cms.gov/files/document/covid-medicare-and-medicaid-ifc2.pdf.
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MITRACLIP DELIVERY SYSTEMS
INDICATION FOR USE
- 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 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.
- 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.
CONTRAINDICATIONS
The MitraClip™ G4 System is contraindicated in patients with the following conditions:
- Patients who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or post procedural anti-platelet regimen
- Patients with known hypersensitivity to clip components (nickel / titanium, cobalt, chromium, polyester), or with contrast sensitivity
- Active endocarditis of the mitral valve
- Rheumatic mitral valve disease
- Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus
WARNINGS
- DO NOT use MitraClip™ outside of the labeled indication.
- The MitraClip™ G4 Implant should be implanted with sterile techniques using fluoroscopy and echocardiography (e.g. transesophageal [TEE] and transthoracic [TTE]) in a facility with on-site cardiac surgery and immediate access to a cardiac operating room.
- Read all instructions carefully. Use universal precautions for biohazards and sharps while handling the MitraClip™ G4 System to avoid user injury. Failure to follow these instructions, warnings and precautions may lead to device damage, user injury or patient injury including:
- MitraClip™ G4 Implant erosion, migration or malposition
- Failure to deliver MitraClip™ G4 Implant to the intended site
- Difficulty or failure to retrieve MitraClip™ G4 system components
- Use caution when treating patients with hemodynamic instability requiring inotropic support or mechanical heart assistance due to the increased risk of mortality in this patient population. The safety and effectiveness of MitraClip™ in these patients has not been evaluated.
- Patients with a rotated heart due to prior cardiac surgery in whom the System is used may have a potential risk of experiencing adverse events such as atrial perforation, cardiac tamponade, tissue damage, and embolism which may be avoided with preoperative evaluation and proper device usage.
- For the Steerable Guide Catheter and Delivery Catheter only:
- The Guide Catheter: the distal 65 cm of the Steerable Guide Catheter with the exception of the distal soft tip, is coated with a hydrophilic coating.
- The Delivery Catheter: coated with a hydrophilic coating for a length of approximately 131 cm.
- Failure to prepare the device as stated in these instructions and failure to handle the device with care could lead to additional intervention or serious adverse event.
- The Clip Delivery System is provided sterile and designed for single use only. Cleaning, re-sterilization and / or re-use may result in infections, malfunction of the device and other serious injury or death.
- Note the product “Use by“ date specified on the package.
- Inspect all product prior to use. Do not use if the package is open or damaged, or if product is damaged.
PRECAUTIONS
- Prohibitive Risk Primary (or degenerative) Mitral Regurgitation
- Prohibitive risk is determined by the clinical judgment of a heart team, including a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, due to the presence of one or more of the following documented surgical risk factors:
- 30-day STS predicted operative mortality risk score of
- ≥8% for patients deemed likely to undergo mitral valve replacement or
- ≥6% for patients deemed likely to undergo mitral valve repair
- 30-day STS predicted operative mortality risk score of
- Porcelain aorta or extensively calcifed ascending aorta.
- Frailty (assessed by in-person cardiac surgeon consultation)
- Hostile chest
- Severe liver disease / cirrhosis (MELD Score > 12)
- Severe pulmonary hypertension (systolic pulmonary artery pressure > 2/3 systemic pressure)
- Unusual extenuating circumstance, such as right ventricular dysfunction with severe tricuspid regurgitation, chemotherapy for malignancy, major bleeding diathesis, immobility, AIDS, severe dementia, high risk of aspiration, internal mammary artery (IMA) at high risk of injury, etc.
- Evaluable data regarding safety or effectiveness is not available for prohibitive risk Primary patients with an LVEF < 20% or an LVESD > 60 mm. MitraClip™ should be used only when criteria for clip suitability for Primary have been met.
- The heart team should include a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease and may also include appropriate physicians to assess the adequacy of heart failure treatment and valvular anatomy.
- Prohibitive risk is determined by the clinical judgment of a heart team, including a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, due to the presence of one or more of the following documented surgical risk factors:
- Secondary Mitral Regurgitation
- Evaluable data regarding safety or effectiveness is not available for secondary MR patients with an LVEF < 20% or an LVESD > 70 mm.
- The multidisciplinary heart team should be experienced in the evaluation and treatment of heart failure and mitral valve disease and determine that symptoms and MR severity persist despite maximally tolerated GDMT.
POTENTIAL COMPLICATIONS AND ADVERSE EVENTS
The following ANTICIPATED EVENTS have been identified as possible complications of the MitraClip™ G4 procedure.
- Allergic reactions or hypersensitivity to latex, contrast agent, anaesthesia, device materials (nickel / titanium, cobalt, chromium, polyester), and drug reactions to anticoagulation, or antiplatelet drugs
- Vascular access complications which may require transfusion or vessel repair including:
- wound dehiscence
- catheter site reactions
- Bleeding (including ecchymosis, oozing, hematoma, hemorrhage, retroperitoneal hemorrhage)
- Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation / rupture, vascular occlusion
- Emboli (air thrombotic material, implant, device component)
- Peripheral Nerve Injury
- Lymphatic complications
- Pericardial complications which may require additional intervention, including:
- Pericardial effusion
- Cardiac tamponade
- Pericarditis
- Cardiac complications which may require additional interventions or emergency cardiac surgery, including:
- Cardiac perforation
- Atrial septal defect
- Mitral valve complications, which may complicate or prevent later surgical repair, including:
- Chordal entanglement / rupture
- Single Leaflet Device Attachment (SLDA)
- Thrombosis
- Dislodgement of previously implanted devices
- Tissue damage
- Mitral valve stenosis
- Persistent or residual mitral regurgitation
- Endocarditis
- Cardiac arrhythmias (including conduction disorders, atrial arrhythmias, ventricular arrhythmias)
- Cardiac ischemic conditions (including myocardial infarction, myocardial ischemia, and unstable / stable angina)
- Venous thromboembolism (including deep vein thrombosis, pulmonary embolism, post procedure pulmonary embolism)
- Stroke / Cerebrovascular accident (CVA) and Transient Ischemic Attack (TIA)
- System organ failure:
- Cardio-respiratory arrest
- Worsening heart failure
- Pulmonary congestion
- Respiratory dysfunction / failure / atelectasis
- Renal insufficiency or failure
- Shock (including cardiogenic and anaphylactic)
- Blood cell disorders (including coagulopathy, hemolysis, and Heparin Induced Thrombocytopenia (HIT))
- Hypotension / hypertension
- Infection including:
- Urinary Tract Infection (UTI)
- Pneumonia
- Septicemia
- Nausea / vomiting
- Chest pain
- Dyspnea
- Edema
- Fever or hyperthermia
- Pain
- Death
- Fluoroscopy, Transesophageal echocardiogram (TEE) and Transthoracic echocardiogram (TTE) -related complications:
- Skin injury or tissue changes due to exposure to ionizing radiation
- Esophageal irritation
- Esophageal perforation
- Gastrointestinal bleeding