Last Modified: 4/5/2024
Location: FL, PR, USVI
Business: Part A, Part B
Transcatheter aortic valve replacement (TAVR), also known as transcatheter aortic valve implantation (TAVI), became nationally covered in 2012 under coverage with evidence development (CED). Therefore, the billing and processing of TAVR claims is different from investigational device exemptions (IDEs) that require First Coast or CMS approval prior to billing for associated routine costs.
The process for submitting a clinical research study to Medicare is outlined in the NCD. Sponsors submit their requests to CMS for approval of their TAVR clinical trial. Once CMS approves a TAVR clinical trial, it is added to the
CMS TAVR website . The sponsors determine the sites that will participate in and recruit patients for the approved TAVR study. The approved study sites are also added to the TAVR website.
CMS does not provide specific billing instructions to sponsors to distribute to their approved study locations. It is up to the sponsors to create and distribute their own billing instructions based on CMS guidelines. It is important to note, however, that billing instructions for TAVR are not the same as billing instructions for IDEs.
Prior to claim submission, providers shall access the
Transcatheter Valve Therapy (TVT) Registry to verify their
participation as an approved TAVR study location. The following instructions are provided to assist approved TAVR study locations with claim submissions to First Coast.
Coding requirements - inpatient hospital claims (Part A)
Hospitals must report:
• 11X type of bill
• ICD-10 TAVR procedure codes
• 02RF37H
• 02RF38H
• 02RF3JH
• 02RF3KH
• 02RF37Z
• 02RF38Z
• 02RF3JZ
• 02RF3KZ
• Secondary diagnosis ICD-10 code Z00.6
• Condition code 30 (qualifying clinical trial)
• Value code D4, which indicates you are reporting a National Clinical Trial (NCT) number
• Valid 8-digit NCT number
• Revenue code 0278 (medical/surgical supplies and devices – other transplant), along with the billed charge
Do not report revenue code 0624 or IDE number (i.e., G160022) or other type of IDE description in the description field. This causes our Part A system to incorrectly look at the IDE number and then look for that IDE number and your PTAN in our system.
Report revenue code 0624 and the IDE number in the description field only for IDE Part A claims, not for TAVR claims since it is nationally covered.
Coding requirements - professional claims (Part B)
• Medicare recognizes the following CPT codes when billing for TAVR:
• 33361 - Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; percutaneous femoral artery approach
• 33362 - Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open femoral artery approach
• 33363 - Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open axillary artery approach
• 33364 - Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open iliac artery approach
• 33365 - Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transaortic approach (for example, median sternotomy, mediastinotomy)
• 33366 - Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transapical exposure (e.g., left thoracotomy)
In addition to one of the above CPT codes, you must report:
• Place of service 21 (inpatient hospital)
• Modifier 62 (two surgeons/co-surgeons)
• Modifier Q0 (investigational clinical service provided in a clinical research study that is in an approved clinical research study)
• Valid 8-digit NCT number
• Secondary diagnosis ICD-10 code Z00.6
Note: When a Medicare Advantage (MA) plan participant receives TAVR services, the MA plans are responsible for payment. Medicare coverage for TAVR is not under section 310.1 of the NCD manual (routine costs in qualifying clinical trials) and it is in these trials that the fee-for-service system is responsible for payment.
References
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