On the fence result for initial CMS vote about TAVI volume requirements

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A Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) panel of the Centers for Medicare & Medicaid Services (CMS), according to Medscape, has not made a firm decision about whether or not specific volume requirements are required for new or continuing transcatheter aortic valve implantation (TAVI) programmes. The panel convened as a part of a CMS national coverage analysis to review the 2012 national coverage determination (NCD) for TAVI.

Medscape reports that, after “hours of data that elicited starkly different conclusions about procedural volume and quality”, the panel votes fell “squarely in the middle” on nine questions about surgical aortic valve replacement, TAVI and percutaneous coronary implantation (PCI) volume requirements for starting or continuing a TAVI programme. The panel had to vote on the level of confidence they had for volume requirements, with “one” being the lowest level of confidence and “five” being the highest level of confidence.

For hospitals with and without a TAVI programme, all of the scores were in the “three” range.  For example, for hospitals starting a new TAVI programme, there was an average score of 3.78 in support of there being sufficient evidence that a specific threshold for surgical aortic valve replacement was required. Similarly, for hospitals with an existing TAVI programme, the average score was 3.56. The average scores for the need for a PCI volume requirement were 3.44 and 3.44 respectively.

In terms of the volume requirements of an individual operator starting a TAVI programme, the panel seemed slightly more confident—the average score for there being sufficient evidence that a certain procedural volume, with either TAVI or surgery, was required for the principal cardiothoracic surgeon was 4.33 and was 4.22 for the principal interventional cardiologist. These scores were 3.33 and 4.11 (and 3.78 for the combined experience of a cardiothoracic surgeon an an interventional cardiologist) for TAVI volume requirements at centres with an existing TAVI programme.

The vote is just part of the CMS’ review of the 2012 NCD for TAVI (or transcatheter aortic valve replacement, TAVR, as it is called in the USA). The 2012 document established specific requirements for coverage for TAVI procedures, which included procedural volume requirements that hospitals must meet if they are to start or continue performing TAVI and receive coverage. It states that for a hospital to begin a TAVI programme, it has to have performed more than 50 aortic valve replacements in the past year and these procedures have to include more than 10 high-risk procedures. It also has to have performed more than 1,000 catheterisations, of which more than 400 have to be for PCI. To continue having a TAVI programme, a hospital had to perform more than 20 aortic valve replacements per year and, again, perform 1,000 catheterisations. The 2012 NCD requirements also set out who should be in the heart team and how much experience the principal operators in these team should have. An interventional cardiologist of a heart team at a hospital planning to start a TAVI programme, for instance, has to have professional experience with 100 structural heart disease procedures or 30 left-sided structural procedures per year (of which, 60% should be balloon aortic valvuloplasty).

After the CMS announced, at the end of June, that it would be holding the MEDCAC panel, the American Academy of Thoracic Surgery (AATS), the American College of Cardiology (ACC), the Society of Cardiovascular Angiography and Interventions (SCAI), and the Society for Thoracic Surgeons (STS) published a joint expert consensus statement of operator and institutional volume requirements for TAVI.

Satya Shreenivas

Writing in the Journal of the American College of Cardiology (JACC),* Joseph E Bavaria (D Department of Cardiovascular Surgery, University of Pennsylvania, Philadelphia, USA) and colleagues report that “case-volume requirements ensure foundational data minimums for measurement of quality outcomes”. However, they say risk-adjusted direct outcome measures should be developed, validated, and introduced for TAVI to replace volume as a measure of quality. Furthermore, they state that they do not recommend that sites failing to meet TAVI or surgery volume requirements should close their programmes. “Rather, the committee recommends that all sites review their quarterly outcome reports and assess if they are within national [US] benchmarks of an acceptable quality of care. An accreditation process is one means to help ensure quality and also provide external review of programmes,” Bavaria et al write. They add that in the USA many regions have a low population density with long distances to tertiary medical care, noting: “TAVI sites have opened in many of these regions and it is important that they remain active if they can document acceptable quality even if they should fall below volume thresholds to maintain patient access to care.”

At the panel, the societies gave a joint presentation about their views on volume requirements. During this presentation, SCAI highlighted the importance of focusing on patient-centred care for aortic stenosis through consideration of the patient experience and pathway to care. According to a SCAI press release, SCAI spokesperson Ted Feldman (NorthShore University Health System, Evaston, USA) told the panel that determination of treatment should always be “the right treatment for the right patient at the right time”.

Edwards Lifesciences, who make the Sapien 3 TAVI device, seemed to be equally concerned about ensuring the right treatment was available for the right patient. Responding to CMS’ announcement that they would be convening a panel, the company said in a press statement: “Our priority will be assuring that the NCD provides all people with heart valve disease with access to all treatment options, enabling patients to choose the right treatment at the right time. We look forward to continuing to engage with the CMS and other stakeholders in the finalisation of this important policy, which will define the future of heart valve patients’ access to this life-saving care.”

However, Medtronic (who produce CoreValve) had a slightly different take on the review. In press statement, the chief medical officer of Medtronic’ structural heart business Pieter Kappetein said that the company had not seen “sufficient evidence to support significant modifications to the current operator and facility volume requirements in the TAVI NCR at this time”. He added that, similar to Edwards, they were committed to collaborating with key stakeholders as the NCD process moves forward and were also committed to “delivering meaningful, evidence-based solutions across the care continuum that provide excellent outcomes for heart valve patients across the globe.”

Operator and procedural volume requirements is not the only aspects of the 2012 NCD being called into question. Writing in Catheterizations and Cardiovascular Interventions, Satya Shreenivas (The Christ Hospital Heart and Vascular Center/The Carl and Edyth Linder Center for Research and Education, Christ Church Hospital, Cincinnati, USA), Scott Lilly (Department of Medicine, Division of Cardiology, Ohio State University, Wexner Medical Center, Columbus, USA) and others claim that the current requirement for two surgeons to independently examine (face-to-face) the patient’s suitability for surgical aortic valve replacement before a patient can be considered for TAVI is a barrier to the efficiency of care, increases unwanted demands, and unnecessary costs for healthcare systems, and “may adversely affect clinical outcomes by delaying care to a broad population of patients for whom aortic valve replacement is indicated”. Shreenivas and Lilly told Cardiovascular News: “The two surgeon rule is a greater impediment to patient access than the volume requirement. If the goal is to get access to rural communities (where two cardiac surgeons are not frequently found), the best way to achieve this goal is to get rid of the two surgeon rule—something that is not backed by any clinical evidence. It is possible that one cardiac surgeon who is providing high quality, high volume care is better than two surgeons providing low volume care.”

* = The document was also published in Catheterizations and Cardiovascular Interventions, The Journal of Thoracic and Cardiovascular Surgery, and The Annals of Thoracic Surgery.

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