Dive Brief:

• CMS has proposed a mixed bag of changes to its coverage policy for transcatheter aortic valve replacement, lessening some restrictions while strengthening others.

• The draft policy retains volume-based restrictions on which hospitals can perform TAVR but seeks to give providers more flexibility in how they meet the criteria.

• Edwards Lifesciences argued CMS should adopt a quality-based model for establishing which hospitals can do TAVR but the agency, echoing the position of Medtronic, thinks more data are needed before abandoning the volume-based approach.

Dive Insight:

CMS brought its current national coverage determination for TAVR into force in 2012. Since then, the sector has grown rapidly, emboldening Edwards, one of two players in the U.S. market, to predict total TAVR sales will hit $7 billion by 2024.

Increasing experience in performing TAVR led some physicians to push back against a CMS policy that limits the procedure to high-volume facilities. In response, CMS agreed to reassess its policy and asked an advisory panel to rule whether the volume-based restrictions improved patient outcomes. The panel was unable to reach a consensus, leaving scope for doubt about how CMS would proceed.

Now, CMS has published its draft policy. The document sets out slightly revised volume criteria that hospitals with and without TAVR experience must meet to perform the procedure. Overall, the proposed rules will make it easier for hospitals to start performing TAVR but harder to keep doing so. That tradeoff was well received by analysts at Jefferies. 

"On balance, the proposed memo looks positive for TAVR adoption. By lessening the requirements for hospitals and clinicians to begin programs, there could be a faster increase in the number of sites offering TAVR in the U.S.," the analysts wrote in a note to investors.  

The greater flexibility touted by CMS comes, in part, from a change in what procedures contribute toward the volume requirements. Under the current rules, hospitals must perform more than 50 open aortic valve replacement surgeries in the year preceding the start of TAVR. The new rules require a site performs 50 open heart procedures of any type in the preceding year, plus 20 aortic valve related procedures over the preceding two years.

However, CMS plans to increase the volume requirements hospitals must meet to maintain TAVR programs. The number of aortic valve replacement procedures a facility must perform each year is set to rise from 20 to 50, creating the possibility that some hospitals with active TAVR programs will need to stop performing the procedure.

The trend elsewhere is toward lighter restrictions. CMS wants to end some requirements altogether. The agency plans to eliminate the need for hospitals to do more than 1,000 catheterizations per year, although it is retaining a volume requirement on percutaneous coronary interventions. CMS also plans to end volume requirements on heart teams with TAVR experience and certain rules on the infrastructure hospitals must possess.  

Other tweaks include the decision to allow hospitals to perform TAVR after one cardiac surgeon has examined the patient. The current rules require two surgeons to look at the patient.

CMS said the proposed policy gives hospitals more flexibility in how they meet requirements while ensuring TAVR only takes place at the sort of high-volume sites it contends deliver the best outcomes. The link between volume and health outcomes was questioned during the consultation, notably by Edwards, but CMS thinks the number of procedures a hospital does remains a relevant indicator.

That position is partly a reflection of the lack of other good predictors of outcomes. Medtronic has argued there is a lack of evidence to justify significant changes to the volume requirements. The new CMS policy seeks to address that evidence gap by calling for the collection of data on variables other than volume that may influence safety and efficacy.  

Those metrics could inform future revisions to the policy but for now CMS plans to retain volume restrictions. The draft policy is open for comment for 30 days. CMS will then take up to 60 days to finalize the document.