Transcatheter Aortic Valve Replacement (TAVR)
Transcatheter aortic valve replacement (TAVR - also known as TAVI or transcatheter aortic valve implantation) is used in the treatment of aortic stenosis. A bioprosthetic valve is inserted percutaneously using a catheter and implanted in the orifice of the aortic valve.
B. Nationally Covered Indications
The Centers for Medicare & Medicaid Services (CMS) covers transcatheter aortic valve replacement (TAVR) under Coverage with Evidence Development (CED) with the following conditions:
There are two sets of qualifications; the first set outlined below is for hospital programs and heart teams without previous TAVR experience and the second set is for those with TAVR experience.
Qualifications to begin a TAVR program for hospitals without TAVR experience:
Qualifications to begin a TAVR program for heart teams without TAVR experience:
Qualifications for hospital programs with TAVR experience:
Qualifications for heart teams with TAVR experience:
The heart team's interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TAVR.
The registry should collect all data necessary and have a written executable analysis plan in place to address the following questions (to appropriately address some questions, Medicare claims or other outside data may be necessary):
Consistent with section 1142 of the Act, the Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies that CMS determines meet the above-listed standards and address the above-listed research questions.
TAVR is covered for uses that are not expressly listed as an FDA-approved indication when performed within a clinical study that fulfills all of the following.
Consistent with section 1142 of the Act, AHRQ supports clinical research studies that CMS determines meet the above-listed standards and address the above-listed research questions.
Director, Coverage and Analysis Group Re: TAVR CED Centers for Medicare & Medicaid Services (CMS) 7500 Security Blvd., Mail Stop S3-02-01 Baltimore, MD 21244-1850
C. Nationally Non-Covered Indications
TAVR is not covered for patients in whom existing co-morbidities would preclude the expected benefit from correction of the aortic stenosis.
Transmittal 145, dated August 3, 2012, is being rescinded and replaced by Transmittal 147, dated September 24, 2012, to include revisions to language in the “Summary of Changes” and clarification to the “Policy Section” of the business requirements for the Pub 100-03 and Pub 100-04 documents. All other information remains the same.
This NCD has been or is currently being reviewed under the National Coverage
Determination process. The following are existing associations with NCAs, from the National
Coverage Analyses database.