Knowledge Base Article

What is Structural Heart Disease?

In recent years, we have seen several of our clients expand their Cardiology Services into the field of Structural Heart. So, what exactly is structural heart disease? In my quest for understanding, I found several different definitions of structural heart disease, the two most pertinent to the focus of this article are from the Journal of American College of Cardiology and the Cardiovascular Research Foundation.

“The term “structural heart disease” entered the adult cardiology lexicon in 1999 and currently encompasses the base of knowledge and competencies surrounding noncoronary cardiac procedures such as transcatheter aortic valve replacement (TAVR), percutaneous mitral repair, and left atrial appendage exclusion.”

• Structural Heart Disease, Curt J. Daniels, Michael J. Landzberg, Robert H. Beekman ,Journal of the American College of Cardiology May 2015, 65 (20) 2260-2261; DOI: 10.1016/j.jacc.2014.12.075

The Cardiovascular Research Foundation defines structural heart disease as covering “a wide range of cardiac conditions, including valvular heart disease and defects in the muscular structure of the heart. The disease may be congenital, as well as acquired. As the American population ages, acquired disease, such as calcific (senile) aortic stenosis and mitral regurgitation has increased in importance, with 12% of adults over the age of 75 being diagnosed with the disease. The past two decades have seen a revolution in the treatment of structural heart disease with transcatheter therapies being developed for valve repair and replacement, closure of defects such as ASD (atrial septal defects), and isolation of the left atrial appendage to reduce embolic risk in atrial fibrillation. Patients who previously could only undergo high risk surgical aortic valve replacement or were completely inoperable can now be treated with a transcatheter approach, often with only a one night stay in the hospital.”

Structural Heart Procedures

With an understanding of structural heart disease, the rest of this article focuses on Medicare Fee-for-Service documentation requirements for the three procedures described in the Journal of the American College of Cardiology’s definition of structural heart disease, specifically:

• Left Atrial Appendage Closure (LAAC) or WATCHMAN™ Procedure,
• Transcatheter Aortic Valve Replacement (TAVR), and
• Transcathater Mitral Valve Repair (TMVR) or MitraClip Procedure.

In addition to documentation requirements, there are very specific billing requirements for the claims to be paid. You can read about the billing requirements in the related article in this week’s newsletter.

Left Atrial Appendage Closure “WATCHMAN™”

The FDA approved the WATCHMAN™ closure technology in March of 2015. This procedure is indicated to reduce the risk of thromboembolism from the Left Atrial Appendage in patients with non-valvular atrial fibrillation (NVAF). CMS published the National Coverage Determination (NCD) for Percutaneous Left Atrial Appendage Closure (20.34) with an effective date of February 8, 2016.

Checklist for hospitals performing WATCHMAN™ procedure

• This procedure is on the Medicare Inpatient-Only Procedure (IPO) List
• The patient must have non-valvular atrial fibrillation,
• The patient must have a CHADS2 score ≥ 2 OR CHA2DS2-VASc score ≥3,
• The patient must participate in a formal Shared Decision Making Encounter (SDM) with an independent non-interventional physician using an evidence based decision tool on oral anti-coagulation in patients with non-ventricular atrial fibrillation prior to procedure.
• Documentation of the SDM must be in the medical record.
• The patient must be suitable for short-term Warfarin but deemed unable to take long-term anticoagulation following the conclusion of the SDM encounter.
• The patient must be under the care of Multidisciplinary Team (MDT) of medical professionals.
• The procedure must be performed by an interventional cardiologist, electrophysiologist, or cardiovascular surgeon who meets the criteria outlined in the NCD to perform the procedure.
• The patient must be enrolled in, and the MDT must participate in a prospective, national audited registry.
• Read the NCD carefully and make sure you are following all of Medicare’s requirements.

Transcatheter Aortic Valve Replacement (TAVR)

TAVR is for the treatment of symptomatic aortic valve stenosis where a biprosthetic valve is inserted percutaneously using a catheter and implanted in the orifice of the native aortic valve. CMS published the National Coverage Determination (NCD) Transcatheter Aortic Valve Replacement (TAVR) (20.32) in May 2012. In June of this year, CMS published a Final Decision Memo making updates to the NCD. One significant change was to change the requirement that two cardiac surgeon’s document a face-to-face encounter with the patient prior to the procedure to requiring a cardiac surgeon and an interventional cardiologist. You can read more about the new decision memo in a related MMP article by Debbie Rubio in a July 2019 edition of the Wednesday@One. The following excerpt is from that article:

Checklist for hospitals that perform the TAVR procedure:

• This procedure is on the Medicare IPO List.
• The patient must have symptomatic aortic valve stenosis;
• The patient must be under the care of a heart team and the heart team's interventional cardiologist(s) and cardiac surgeon(s) jointly participate in the intra-operative technical aspects of TAVR;
• The hospital must have the appropriate infrastructure for the procedure;
• Your medical record must contain documentation of the face-to-face patient examinations by a cardiac surgeon and an interventional cardiologist (experienced in the care and treatment of aortic stenosis) evaluating the patient’s suitability for surgical aortic valve replacement (SAVR), TAVR or medical or palliative therapy;
• Assess your hospital and heart team volumes to be sure you meet the requirements for performing the procedure under the new Decision Memo; and
• Read the new Decision Memo carefully and make sure you are following all of Medicare’s requirements.

Transcatheter Mitral Valve Repair (TMVR) MitraClip

The FDA approved the first TMVR device on October 24, 2013. 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.” CMS published the National Coverage Determination (NCD) for Transcatheter Mitral Valve Repair (TMVR) (20.33) with an effective date of August 7, 2014.

On August 14, 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 is February 14, 2020.

The issue identified in the NCA is that currently this procedure is covered for the treatment of degenerative (primary) mitral regurgitation (MR) involving a structural abnormality. However, there are two types of MR and currently this procedure is not covered for the treatment of functional (secondary) MR which is a distinct condition that generally results from left ventricular dysfunction.

Checklist for hospitals that perform the TMVR procedure:

• This procedure is on the Medicare IPO list.
• The ICD-10-CM diagnoses supporting medical necessity for service provided both describe a nonrheumatic condition. Documentation in the medical record must specify if the valve insufficiency is Nonrheumatic or rheumatic as the Second Quarter 2019 Coding Clinic guidance advises that ICD-10-CM assumes aortic and mitral valve disease is rheumatic in nature when it is not described as non-rheumatic.
• Currently, the procedure is approved for the treatment of significant symptomatic degenerative MR.
• The patient must have a face-to-face encounter by a cardiothoracic surgeon experienced in mitral valve surgery and a cardiologist in mitral valve disease. The encounter must evaluate the patient’s suitability for mitral valve surgery and determination of prohibitive risk, and both must have documented their rationale for their clinical judgement in the medical record.
• The patient must be under the care MDT of healthcare professionals.
• Assess your hospital infrastructure and heart team volumes to be sure you meet the requirements for performing this procedure.
• The heart team’s interventional cardiologist or a cardiothoracic surgeon must perform the TMVR.
• Read the NCD carefully and make sure you are following all of Medicare’s requirements.

This article is meant to help providers with a structural heart program perform a self-assessment to validate that your claims support the medical necessity requirements outlined in the NCDs. This article is also meant to be a starting point for those providers considering or in the early stages of a structural heart program become knowledgeable about the CMS medical necessity. Additionally, MMP has developed procedure specific tip sheets. Click here to download the tip sheet for Left Atrial Appendage Closure (LAAC), here for Transcatheter Aortic Valve Replacement (TAVR), and here for Transcatheter Mitral Valve Repair (TMVR).