CMS confirmed in a national coverage proposal released earlier this month its plans to keep tight controls over the long-term use of transcatheter aortic valves, reflecting what many say is a new reality of stricter evidence demands from the Medicare agency.

The draft policy, issued Feb. 2, tracks closely with last year’s coverage request by the American College of Cardiology and the Society of Thoracic Surgeons. (See Also see "CMS Jumps Out Ahead Of FDA With Transcatheter Valve Coverage Analysis" - Medtech Insight, 3 October, 2011..)

The proposal comes only three months after the approval and launch of Edwards Lifesciences’ Sapien, the first transcatheter aortic valve in the U.S. It restricts coverage to FDA-approved indications, and it includes a coverage-with-evidence-development provision requiring all beneficiaries receiving a valve to be entered into a data registry that tracks outcomes for five years on stroke, all-cause mortality, repeat aortic valve procedures, quality-of-life measures and other endpoints. ACC and STS recently launched the qualifying registry.

It also stipulates that two cardiac surgeons must evaluate a patient for conventional open valve surgery prior to a recommendation for a transcatheter procedure. And it details very specific volume, experience and certification requirements for facilities and operators that perform the nascent procedure, including an emphasis on the “heart team” concept where surgeons, interventional cardiologists and other providers must establish a new type of collaborative approach for treating transcatheter valve candidates. (See Also see "Reimbursement In Brief" - Medtech Insight, 6 February, 2012..)

The proposal includes an element of flexibility recommended by ACC and STS: Rather than explicitly spelling out the current FDA-approved labeling to define the coverage population, CMS words its draft decision so that new FDA-approved indications would automatically be included in the coverage-with-evidence-development policy without the need for a new coverage determination process.

In November, Edwards gained approval for Sapien for use in patients with severe aortic valve stenosis who are deemed to be too sick or frail for the open surgical procedure, and the company is pushing for approval this year in patients who are candidates, but are at high risk, for open surgery. From there, Edwards and other firms developing the technology plan to continue to expand the labeled population to lower-risk patients. (See Also see "The Latest On Transapical: Edwards Talks Up Sapien CAP Data" - Medtech Insight, 6 February, 2012..)

But the proposal also includes some stricter requirements than requested. In particular, the national policy would cover use of transcatheter valves in off-label indications in the context of highly controlled clinical studies, but only in studies that have a statistical superiority, rather than non-inferiority, design. Neither of the two major ongoing FDA pivotal trials for next-generation transcatheter valves – Edwards’ PARTNER II trial and Medtronic’s CoreValve trial – have superiority designs. (See [A#111108g1].)

CMS Evidence Demands On The Rise

Establishing national coverage restrictions so early in the market life of transcatheter valves aligns with a general move by CMS toward more national coverage determinations with stricter evidence requirements, suggested Edward Dougherty, senior health care advisor with Arent Fox, during a Feb. 6 call hosted by Morgan Stanley.

CMS has also recently indicated its plans to revamp its coverage-with-evidence-development policy and potentially increase use of the program as part of its national coverage process. (See Also see "Device Makers Want Say In Medicare 'Coverage-With-Evidence-Development' Policy" - Medtech Insight, 30 January, 2012..)

“CMS is increasingly exercising its authority to make decisions about access to specific technologies for the beneficiaries for whom it has responsibility,” Dougherty said.

“The process of getting a PMA approval for marketing in the U.S. is so rigorous that it’s frankly irritating to many [manufacturers] that there is yet this new hoop that they have to jump through,” he noted, but, “the reality is that will not change.”

ACC and STS issued a statement supporting the proposed national coverage policy. Edwards has yet to specifically weigh in on the proposal, but the company has stated that it is comfortable with a national coverage policy that reflects FDA labeling. (See Also see "Sapien Valve Reimbursement Begins Taking Shape, But Key Questions Remain" - Medtech Insight, 8 August, 2011..)

Meanwhile, other companies developing transcatheter valve devices, including Medtronic and St. Jude Medical, have pressed for CMS to relinquish more control to local Medicare contractors rather than establishing tight restrictions at the national level. (See Also see "Transcatheter Valve Stakeholders Weigh Merits Of Local Vs. National Coverage" - Medtech Insight, 7 November, 2011..)

Dougherty, however, suggests it is highly unlikely that CMS can be swayed much from its current trajectory, at least in the short term.

“There would need to be some published, peer-reviewed or unpublished, clearly analyzed data from prospective trials that demonstrate that these restrictions were no longer necessary,” he noted. “Absent that type of data, I would not expect CMS to be responsive to any requests for change,” he said.

CMS is expected to issue a final national coverage determination by May 2. Comments are due to the agency by March 3.

Transcatheter Valve Coverage Proposal Reflects Stricter Medicare Environment

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