CMS Covers New Technology for Heart Valve Damage

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  • May 11, 2012
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The Centers for Medicare & Medicaid Services (CMS) now covers transcatheter aortic valve replacement (TAVR) for Medicare patients, under certain conditions.
According to CMS, coverage for TAVR is approved under Coverage with Evidence Development (CED) only for the treatment of severe symptomatic aortic valve stenosis when all of the following five conditions are met:

  1. The procedure is furnished with a complete aortic valve and implantation system that has received FDA premarket approval for that system’s FDA-approved indication.
  2. Two cardiac surgeons have independently examined the patient face-to-face and evaluated the patient’s suitability for open aortic valve replacement (AVR) surgery; and both surgeons have documented the rationale for their clinical judgment and the rationale is available to the heart team.
  3. The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multi-disciplinary, team of medical professionals. The heart team concept embodies collaboration and dedication across medical specialties to offer optimal patient-centered care. TAVR must be furnished in a hospital with an appropriate infrastructure as specified in the decision memo.
  4. The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TAVR.
  5. The heart team and hospital are participating in a prospective, national, audited registry that: 1) consecutively enrolls TAVR patients; 2) accepts all manufactured devices; 3) follows the patient for at least one year; and 4) complies with relevant regulations relating to protecting human research subjects, including 45 CFR Part 46 and 21 CFR Parts 50 and 56.

The following outcomes must be tracked by the registry; and the registry must be designed to permit identification and analysis of patient, practitioner and facility level variables that predict each of these outcomes:

  • Stroke
  • All cause mortality
  • Transient Ischemic Attacks (TIAs)
  • Major vascular events
  • Acute kidney injury
  • Repeat aortic valve procedures
  • Quality of Life (QoL)

See the decision memo for further specifications about the registry requirements.
CMS is requesting public comments, specifically about the use of CED, on the proposed determination pursuant to section 1862(l) of the Social Security Act. After considering the public comments, CMS will make a final determination and issue a final decision memorandum.
You can read the tracking sheet, proposed decision memo, decision memo, and view public comments documents on the CMS website.

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