CMS will reimburse for TAVR, with restrictions

Sapien transcatheter aortic valve. Source: Edwards Lifesciences

The Center for Medicare & Medicaid Services (CMS) ruled May 1 that it would cover transcatheter aortic valve replacement (TAVR) under its Coverage with Evidence Development, but the agency included a series of conditions that must be met to receive reimbursement.

The stipulations are, in part, that:

• The complete aortic valve and implantation system has received FDA premarket approval (PMA) for that system’s FDA approved indication.
• Independently, two cardiac surgeons have examined and evaluated the patient for suitability for open aortic valve replacement (AVR) surgery, with documented rationale for their clinical judgment that is made available to the heart team.
• The patient (preoperatively and postoperatively) is under the care of a heart team.
• The heart team’s interventional cardiologist or cardiologists and cardiac surgeon or surgeons must jointly participate in the intra-operative technical aspects of TAVR.
• The heart team and hospital participate in a prospective, national, audited registry that consecutively enrolls TAVR patients, accepts all manufactured devices, follows the patient for at least one year and complies with regulations for protecting human research subjects.

American College of Cardiology (ACC) President  William A. Zoghbi, MD, praised the decision, calling TAVR a transformative technology and saying the ACC supports requirements such as the use of a heart team and registry to ensure quality care. “The ACC hopes this NCD [National Coverage Decision] proves to be a successful model for providing rapid access to promising new technologies for Medicare beneficiaries while focusing on patient safety, quality care and outcome,” Zoghbi said in a statement.

The CMS added that TAVR is covered for uses not expressly listed as an FDA approved indication when performed within a clinical study but that it is not covered for patients whose existing co-morbidities would preclude the expected benefit from the procedure.

Under the benefit category, CMS provided this guidance: “For an item or service to be covered by the Medicare program, it must fall within one of the statutorily defined benefit categories outlined in the Social Security Act. TAVR falls under the benefit categories set forth in section §1861(b)(3) (inpatient hospital services), a Part A benefit under §1812(a)(1) and §1861(s)(1) (physician services), a Part B benefit. This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.”

The decision documents are available here.