National Coverage Analysis (NCA) Tracking Sheet

Transvenous (Catheter) Pulmonary Embolectomy

CAG-00457R

Issue

Pulmonary embolism (PE) typically occurs when a thrombus (clot) that forms in the body, such as in the deep veins of the legs, breaks loose, travels through the venous system, and gets lodged in one or more pulmonary arteries in the lungs. Patients diagnosed with acute PE are risk-stratified to guide appropriate treatment. Depending on the risk of death, treatment escalates from standard anticoagulation (to prevent future clots from forming), to systemic fibrinolysis (intravenous drugs that break up existing clots), and then to catheter-directed therapies as an alternative to surgical embolectomy. These treatments are often used in combination in certain patients. Transvenous (catheter) pulmonary embolectomy is a procedure to remove the clot by passing a catheter (typically through the fermoral vein) and mechanically extracting the clot.

Transvenous (Catheter) Pulmonary Embolectomy is currently non-covered.

CMS internally generated this NCA reconsideration based upon stakeholder feedback. We received three requests for CMS to remove the NCD using the expedited process established in the August 7, 2013 Federal Register (78 FR 48164). We also received nine comments to the 2021 Medicare Physician Fee Schedule Proposed Rule recommending that CMS consider removing this NCD in the future.

Benefit Category

Physicians' Services

Requestor Information

Requestor NameRequestor Letter
Internal request N/A

Important Dates

Formal Request Accepted and Review Initiated
04/13/2021
Expected NCA Completion Date
11/09/2021
Public Comment Period
04/13/2021 - 05/13/2021
Proposed Decision Memo Released
08/11/2021
Proposed Decision Memo Public Comment Period
08/11/2021 - 09/10/2021
Decision Memo Released
10/28/2021
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
David Dolan
david.dolan@cms.hhs.gov
410-786-3365
Lead Medical Officers
Joseph Dolph Hutter, MD, MA

Actions Taken

April 13, 2021

CMS initiates this national coverage analysis for Transvenous (Catheter) Pulmonary Embolectomy. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the topic under review.

Instructions on submitting comments can be found at: http://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html.

To submit a comment, please use the orange "Comment" button at the top of the page. Enter comments directly into the "Submit A Public Comment" webpage.

August 11, 2021

October 28, 2021