CMS suggests it is not satisfied with data supporting two highly anticipated new cardiac technologies, signaling potential reimbursement challenges ahead for both devices.

Boston Scientific’s Watchman left atrial appendage closure device for stroke and CardioMEMS’ Inc.’s CardioMEMS implantable heart failure monitoring system are both candidates for a new-technology add-on payment in the Medicare hospital inpatient system in fiscal year 2015. (See Also see "CMS Announces FY 2015 New-Tech Add-On Payment Applicants" - Medtech Insight, 6 January, 2014..)

The extra reimbursement would help hospitals cover the costs of the devices while CMS collects data to determine an appropriate long-term reimbursement level. But in its FY 2015 hospital inpatient prospective payment system proposed rule, CMS questions whether either device can meet the “substantial clinical improvement” threshold to qualify for an add-on payment.

Watchman Really Superior?

Watchman gained strong support from an FDA advisory panel last December as an alternative to the drug warfarin to prevent stroke in patients with non-valvular atrial fibrillation. (See Also see "Advisory Panel Endorses Boston Scientific’s Watchman Left Atrial Appendage Closure Device" - Medtech Insight, 13 December, 2013..) Boston Scientific hopes the agency will approve it in the coming months, but the device has traveled a long road so far. Watchman underwent its first FDA panel meeting in 2009, where it received only measured support. FDA subsequently asked the company to follow up on its initial PROTECT AF pivotal trial with a new study, PREVAIL, to collect more data on device safety issues.

Even after the second trial, however, CMS remains unconvinced. “We are concerned that the evidence presented by the applicant demonstrating the superiority of the Watchman System compared to warfarin therapy is insufficient,” the Medicare agency writes in the proposed rule.

The agency points out that the original primary endpoint of the PROTECT AF trial only proves non-inferiority to warfarin, even though the company argues that longer term data from the trial shows superior efficacy for the device. But CMS says the long-term data “remains sparse.”

CardioMEMS Clinical Value Questioned

CardioMEMS and St. Jude Medical, which has a 19 percent stake in the company, are hoping for approval in the first half of the year for the CardioMEMS monitor. CardioMEMS measures and remotely transmits data on pulmonary artery pressure as a means to help manage a patient’s heart failure to reduce hospitalization.

Like Watchman, the device has followed a tortuous regulatory development pathway. The device had its second FDA panel meeting last October following an unsuccessful panel in 2011. In October, the agency’s advisors provided a mixed judgment on the device, but a majority said its benefits outweighed its risks. (See Also see "CardioMEMS Has Better Luck With FDA Advisory Panel Second Time Around" - Medtech Insight, 11 October, 2013..)

CMS still sees some significant questions that need answering. For one, the agency says that the add-on payment application did not discuss long-term mortality outcomes. “We believe additional long-term outcome information and how the technology changes long-term outcomes would further assist in our determination of whether the technology represents a substantial clinical improvement,” CMS writes.

The proposed rule also pointedly notes that while CardioMEMS’ data support a reduction in total hospitalizations with the device, “the rate of hospitalization in each group does not appear to be clinically meaningful.” For instance, CMS observes that the “total days alive out of the hospital” is virtually identical with and without the device.

Decisions By August

CMS does not explicitly propose an up or down decision on any new-tech add-on requests in the proposed rule, which it uses as a vehicle for collecting comments on the add-on applications. But the serious questions included in the proposal probably reduce the chances for both Watchman and CardioMEMS.

In addition to substantial clinical improvement, to qualify for the add-on payment, devices also need to be certifiably new and have a cost that exceeds the standard Medicare payment for its procedure category. Also, to be eligible for the payment in FY 2015, Watchman and CardioMEMS will need FDA approval by July 1.

CMS is also critical of the new-tech add-on credentials of Abbott Laboratories’ MitraClip transcatheter mitral valve repair device in the proposed inpatient rule. (See Also see "TAVR Gets Love, MitraClip Gets None In Medicare Inpatient Proposal" - Medtech Insight, 1 May, 2014..)

CMS will collect comments on the proposed rule through June 30. A final rule including decisions on the new-tech add-on payment requests will be issued by Aug. 1, taking effect on Oct. 1

CMS Skeptical Of Watchman, CardioMEMS Data For New-Tech Add-Ons

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