Knowledge Base Article

Background

Last June CMS released a Final Decision Memo (CAG-00430R) for Transcatheter Aortic Valve Replacement (TAVR) Procedures. This procedure 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.

Final Decision Memo: What Did Not Change

Coverage under Evidence Development

The requirement that a procedure be performed under Coverage with Evidence Development (CED) did not change in the Final Decision Memo. CED means that the service is only covered in the context of a clinical trial (such as a national registry or a clinical study). This allows limited coverage for Medicare beneficiaries in a controlled environment while determining the efficacy, risks, and outcomes of the procedure. Once a new technology or procedure is proven to be safe and effective, CMS may remove the CED requirement and cover the procedure outright within set criteria.

• TAVR is covered according to CMS criteria when the procedure is furnished with a complete aortic valve and implantation system that has received FDA premarket approval (PMA) for that system’s FDA approved indication and the heart team and hospital are participating in a prospective, national, audited registry.
• TAVR is covered for uses that are not expressly listed as an FDA-approved indication when performed within a clinical study that fulfills criteria set forth in the decision memo.

Link to CMS TAVR CED webpage: https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/TAVR

The Heart Team

• The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multi-disciplinary, team of medical professionals:
• The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TAVR; and
• TAVR must be furnished in a hospital with the appropriate infrastructure.

Final Decision Memo: What Did Change

Pre-Procedure Patient Evaluation Requirements

Historically, the TAVR National Coverage Determination (NCD) 20.32 required a face-to-face evaluation of a patient’s suitability for TAVR surgery by two cardiac surgeons. The most recent Final Decision Memo changed the requirement from two cardiac surgeons to a cardiac surgeon and an interventional cardiologist. This change is in line with the requirement of the heart team’s interventional cardiologist(s) and cardiac surgeon(s) jointly participating in the intra-operative technical aspects of TAVR. Following is specific guidance from the Final Decision Memo:

• “The heart team includes the following:
• Cardiac surgeon and an interventional cardiologist experienced in the care and treatment of aortic stenosis who have:
• Independently examined the patient face-to-face, evaluated the patient’s suitability for surgical aortic valve replacement (SAVR), TAVR or medical or palliative therapy;
• Documented and made available to the other team members the rationale for their clinical judgement.
• Providers from other physician groups as well as advanced patient practitioners, nurses, research personnel and administrators.”

Note, in general, I have seen most denials from Medicare Contractors for this procedure being due to a lack of documentation of a face-to-face encounter by two surgeons. What I have found in performing claim reviews for MMP clients is that often there was documentation from a surgeon and an interventional cardiologist which now meets the face-to-face requirement.

Hospital Specific Procedure Volumes

The prior version of the NCD and Final Decision memo both required certain volumes of procedures for the hospital and the heart team based on whether they had previous TAVR experience or not.

For example, hospitals with no previous TAVR experience, the volume of Aortic Valve Replacements has decreased while a specific volume of open heart surgeries and having at least one physician with interventional cardiology privileges has been added to the NCD. Whether or not you currently perform TAVR procedures or are in the planning phase of performing these procedures, I encourage you to review the new requirements in NCD 20.32.

August 16, 2019 FDA Announcement:  FDA Expands Indication for Several Transcatheter Heart Valves to Patients at Low Risk for Death or Major Complications Associated with Open-Heart Surgery

Last August, “the U.S. Food and Drug Administration today approved an expanded indication for several transcatheter heart valves to include patients with severe aortic valve stenosis (a narrowing of the heart’s aortic valve that restricts blood flow to aorta, the body’s main artery) who are at low risk for death or major complications associated with open-heart surgery to replace the damaged valves. These transcatheter valves – Sapien 3, Sapien 3 Ultra, CoreValve Evolut R and CoreValve Evolut PRO – were previously indicated only for patients at intermediate or higher risk for death or major complications during open-heart surgery.

In low risk patients, open-heart surgery has been the standard-of-care for aortic valve replacement. However, the procedure to insert a transcatheter heart valve is less invasive, and involves a smaller incision and shorter recovery time than open-heart surgery. The FDA is the first medical products regulatory body in the world to expand the indication for these devices to patients at low risk for death or major complications associated with open-heart surgery.”

Final Decision Memo Changes are Now Effective

• Effective Date: June 21, 2019
• Implementation Date: June 12, 2020.

As always, with Decision Memos, the requirements are not effective until the NCD is updated and implemented. However, NCD revisions generally revert to the effective date of the Decision Memo, which is in this case June 21, 2019.

On Friday March 13th CMS published Change Request (CR) 11660  informing Medicare Administrative Contractors (MACs) that effective June 21, 2019, CMS will continue to cover TAVR under CED when the procedure is furnished for the treatment of symptomatic aortic stenosis and according to an FDA approved indication for use with an approved device, in addition to the coverage criteria outlined in the NCD manual. The Implementation date is June 12, 2020.

On Tuesday 3/24/2020 CMS published related MLN Matters Article MM11660.

TAVR Hospital “To Do” List

• Read the updated NCD carefully, making sure you are following all of Medicare’s requirements.
• Ensure your medical record contains 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) evaluated the patient’s suitability for SAVR, TAVR or medical or palliative therapy;
• Ensure your hospital has the appropriate infrastructure for the procedure;
• Assess your hospital and heart team volumes to be sure you meet the requirements for performing the procedure under the new Decision Memo; and
• Ensure the patient is 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.