Knowledge Base Article

On March 26, 2019 CMS published a Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R). In a related CMS Press Release CMS noted they would continue to cover TAVR under Coverage with Evidence Development (CED) when furnished according to an FDA-approved indication.

TAVR Background

CMS first released National Coverage Determination (NCD) 20.32 Transcatheter Aortic Valve Replacement (TAVR) with an effective date of May 1, 2012. At that time, TAVR was considered a new technology for use in treating patients with aortic stenosis where a biprosthetic valve is inserted percutaneously using a catheter and implanted in the orifice of the native aortic valve.

TAVRs are performed in a cardiac catheterization lab or a hybrid operating room/cardiac catheterization lab with advanced quality imaging and with the ability to safely accommodate complicated cases that may require conversion to an open surgical procedure. The interventional cardiologist and cardiothoracic surgeon jointly participate in the intra-operative technical aspects of TAVR.

NCD 20.32 allows for coverage of the TAVR Procedure under Coverage with Evidence Development (CED) with specific conditions being met, appropriate volume requirements and a heart team and hospitals participation in a prospective, national, audited registry. For indications not approved by the FDA, CMS covers TAVR under CED when a patient is enrolled in a qualifying clinical study.

Registry and Clinical Study Approvals by CMS can be found on the CMS Coverage with Evidence Development TAVR webpage. https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/TAVR.html

TAVR Hospital Volumes

TAVR procedures are on the Medicare Inpatient Only Procedure List and sequence to the MS-DRG Pair 266 and 267 (Endovascular Cardiac Valve Replacement with MCC and without MCC respectively). In CMS Fiscal Year (FY) 2015 through 2017, this MS-DRG pair also included ICD-10-PCS codes for replacement of pulmonary valves. In FY 2018 an additional 4 mitral valve codes and 8 new tricuspid valve codes were also added to this MS-DRG pair.

To provide you with a glimpse into these types of procedures, I utilized Medicare Fee-for-Service paid claims data from our sister company RealTime Medicare Data (RTMD) for CMS FY 2015 through 2018. The following table highlights an increase in volumes and average charges and a decrease in actual average payment and average length of stay (ALOS) for Medicare Fee-for-Service paid claims in Alabama, Georgia and Tennessee.

‍Proposed Decision Memo: Changes and CMS’ Request for Comments

The Decision Memo proposes to update “the coverage criteria for hospitals and physicians to begin or maintain a TAVR program. The proposed decision provides more flexibility in how providers can meet the requirements performing TAVR, while continuing to ensure good health outcomes for patients receiving the procedure.”

The CMS Press Release notes they are also seeking to gather additional information and specifically proposed “a question regarding the relationship between other metrics and patient health outcomes, which could inform a future change to replace the volume criteria with a different metric.”

Key stakeholders at your hospital should take the time to read the Proposed Decision Memo and provide public comments. There is a 30-day public comment period ending April 25th and a final decision will be issued no later than 60 days after the conclusion of the 30-day public comment period. All public comments may be submitted at https://www.cms.gov/medicare-coverage-database/indexes/nca-open-for-public-comment-index.aspx.

Link to NCD 20.32: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=355&ncdver=1&bc=AAAAgAAAAAAAAA%3d%3d&