February 3rd, 2012

CMS Releases Details of Proposed National Coverage for TAVR

On Thursday the Centers for Medicare & Medicaid Services (CMS) released a memo containing details of its proposed Medicare coverage for transcatheter aortic valve replacement (TAVR). The memo is a response to a formal request for national coverage determination (NCD) from the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC). The memo will be open for public comment until March 3, after which a final determination will be made.

In the memo CMS proposes coverage for TAVR only if 5 conditions are met, including

  1. The use of an FDA-approved device for an FDA-approved indication,
  2. Evaluation of the patient by 2 cardiac surgeons,
  3. Performance of the procedure at an institution with sufficient surgical and interventional cardiology experience and expertise, including participation in a prospective national TAVR study and a commitment to the Heart Team concept,
  4. Performance by physicians with sufficient experience and expertise,
  5. The patient must be enrolled in, and the physician must participate in, a national TAVR registry that will track outcomes for at least five years after the procedure.

CMS also said it would provide coverage for patients enrolled in clinical trials that meet a long list of criteria. CMS recommended that coverage be denied for indications other than those specifically mentioned in the memo.

One Response to “CMS Releases Details of Proposed National Coverage for TAVR”

  1. Take note of the CMS proposed rule on TAVR. Let’s look at the details. This is your chance to comment to CMS – and to your colleagues here. Do you agree with these thresholds? I commend the group for fairly tough requirements, including participation in a national registry… what do you think?

    The procedure is furnished in a facility that meets the following institutional requirements:

    For centers without previous PMA clinical trial TAVR experience
    Surgical program requirements:
    ≥ 50 total aortic valve replacement (AVR) procedures/year, including ≥ 10 patients with STS (Society of Thoracic Surgeons) Score ≥ 6;
    ≥ 2 institutionally based cardiac surgeons.

    Interventional program requirements:
    ≥ 400 caths/150 PCI’s (percutaneous interventions) per year;
    ≥ 15 left-sided structural (EVAR [endovascular aneurysm repair], TEVAR [thoracic endovascular aortic repair], etc.) interventions per year.

    For centers with previous PMA clinical trial TAVR experience
    Participation in ongoing TAVR programs, either randomized controlled trials (RCTs) or post-approval study (PAS);
    Experience with ≥ 30 TAVR procedures and ≥ 20/year;
    TAVR program requirements:
    ≥ 20 procedures/year OR ≥ 40 procedures/2 years;
    30 day all-cause mortality ≤ 15%;
    30 day neurologic events ≤ 15%;
    ≥ 90% institutional follow-up of patients;
    ≥ 60% one year survival for non-operable patients.

    For all centers, with or without previous PMA clinical trial TAVR experience:
    Participation in a prospective national TAVR study for ongoing enrollment and follow up of all TAVR patients;
    Commitment to Heart Team concept.