Knowledge Base Category -

Transcatheter Aortic Valve Replacement (TAVR - also known as TAVI or Transcatheter Aortic Valve Implantation) is a new technology for use in treating certain patients with aortic stenosis. A bioprosthetic valve is inserted percutaneously using a catheter and implanted in the orifice of the native aortic valve.

Effective for dates of service on or after May 1, 2012, Medicare will cover TAVR under Coverage with Evidence Development (CED) when specific requirements are met.

1. CMS covers TAVR for the treatment of symptomatic aortic valve stenosis under CED with the following conditions:
2. there is FDA approval of the indication and corresponding system,
3. two cardiac surgeons are involved,
4. the patient is under the care of a heart team, and
5. the hospital and heart team meet certain requirements including participation in a prospective, national, audited registry.
6. For indications that are not approved by the FDA, CMS covers TAVR under CED when patients are enrolled in qualifying clinical studies.

Currently, CMS has approved only one registry and two clinical studies. The approved registry is the Transcatheter Valve Therapy Registry operated by the Society of Thoracic Surgeons and the American College of Cardiology. Approved registries and qualifying clinical studies can be viewed at TAVR CED.

Inpatient Hospital Claims Coding/Billing Requirements

Note that the TAVR procedures are all on the Medicare inpatient-only list and therefore should only be performed on patients formally admitted as inpatients.

• Type of Bill (TOB): 11X
• Effective date: for discharges on or after May 1,2012
• ICD-9 procedure codes: 35.05(Endovascular replacement of aortic valve) or 35.06(Transapical replacement of aortic valve)
• Secondary diagnosis code: V70.7(Examination of participant in clinical trial)
• Condition code: 30 (qualifying clinical trial).

There are numerous, detailed requirements for coverage for this procedure. For complete information regarding the NCD requirements and Claims Processing instructions please refer to MLN Matters Article MM7897.