The Centers for Medicare & Medicaid Services (CMS) has finalised its update the US coverage for transcatheter aortic valve implantation (TAVI). It will continue to provide coverage with evidence development when furnished according to an FDA-approved indication. However, it has updated the coverage criteria for hospitals and physicians to begin or maintain a TAVI programme—allowing greater flexibility for hospitals and providers to meet the requirements for performing TAVI.
According to a statement from CMS, the decision comes in response to the continued development of TAVI and streamlines key elements of the original national coverage determination that went into effect in 2012.
In developing the decision, CMS met with numerous stakeholders including medical professional societies, who recommended requirements for hospitals and physicians to perform a certain volume of heart procedures. The decision includes updated volume requirements for hospitals and physicians to begin and maintain TAVI programmes.
The decision aims to reflect the current evidence base and to strike an appropriate balance between ensuring that hospitals have the experience and capabilities to handle complex heart disease cases while limiting the burden and barriers that excessive requirements create for hospitals and patients. CMS states that it will continue to follow efforts by medical societies to develop TAVI-specific outcome measures, and the agency will encourage continued progress toward the establishment of such widely-supported measures as potential replacements for procedural volume criteria.
CMS Administrator Seema Verma says: “[The] decision to update and streamline the TAVI coverage parameters demonstrates CMS’ ongoing commitment to our beneficiaries. The modification to the TAVI hospital and physician requirements is generally consistent with the 2018 Consensus Statement from the American College of Cardiology, the American Association for Thoracic Surgery, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons. The decision ensures improved access to care for beneficiaries while supporting the continued evolution of this important technology in light of emerging evidence.”
The decision was made in response to a formal request and is consistent with recommendations from a meeting of the MEDCAC (Medicare Evidence Development & Coverage Advisory Committee) on July 25, 2018. The MEDCAC provides CMS with an external review of medical literature, technology assessments, public testimony, and other data and information on the benefits, harms, and appropriateness of therapies under review.
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