The Centers for Medicare and Medicaid Services have updated the criteria for hospitals and physicians to begin or continue providing transcatheter aortic valve replacement surgery. The decision gives hospitals and providers more flexibility to meet the CMS requirements for performing TAVR, the agency said Friday.
The original National Coverage Determination (NCD) for TAVR procedures was cleared in 2012, when the technology and associated procedure were still new. The new policy updates requirements based on new information about the safety and viability of the procedures. CMS released its proposal to update TAVR coverage in March.
CMS raised the volume requirements for existing TAVR programs at hospitals looking to receive CMS reimbursement. Previously, hospitals were only required to perform 20 aortic valve replacements per year or 40 per two years – that requirement has been more than doubled to either 50 AVRs per year or 100 AVRs per two years.
For hospitals looking to begin TAVR programs, the volume requirements stayed mostly the same, but language was shifted from 50 total AVRs per year to 50 open heart surgeries in the year prior to the program launch and at least 20 aortic valve related procedures in the two years prior to launch.
CMS said it 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 reflects current evidence and strikes 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, according to the agency.
“Today’s decision to update and streamline the TAVR coverage parameters demonstrates CMS’ ongoing commitment to our beneficiaries,” CMS administrator Seema Verma said in a news release. “The modification to the TAVR 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.”
CMS said it will continue to follow efforts by medical societies to develop TAVR-specific outcome measures, and that it will encourage continued progress toward establishing these measures as potential replacements for its requirements for certain numbers of procedures.
TAVR-makers Edwards Lifesciences (NYSE:EW) and Medtronic (NYSE:MDT) hailed the agency’s decision, although Edwards and Medtronic both said they are not changing their financial guidance.
“Often, the primary risk facing severe aortic stenosis patients is not treatment complications, but the risk of not receiving treatment at all,” Edwards said in a news release. “Many of the core elements of the updated NCD better reflect today’s practices in the treatment of patients with severe AS (aortic stenosis), the needs of those patients and the robust evidence and technology enhancements that have occurred in the last several years. We believe the modernized requirements and more streamlined patient evaluation process are meaningful enhancements that may help ensure equitable access for more patients suffering from severe AS.”
Edwards also said it is encouraged that CMS is open to moving toward a quality measure focused on patient outcomes, not procedural volume, in evaluating hospitals eligible to provide TAVR in the U.S.
“Medtronic supports the updated TAVR NCD and believes the new coverage policy allows for appropriate patient access to TAVR — especially for patients in rural communities — while still maintaining rigorous requirements for centers and operators providing the therapy,” the company said in a news release. “Medtronic has been an active participant over the past year during the National Coverage Analysis (NCA) and its public commenting periods and provided several recommendations to support patients continuing to have sufficient access to TAVR therapy. We are pleased to see that today’s decision is consistent with our position.”
