Industry Pushes CMS For Details On Centralized Coverage Review Of IDE Trials

Whether they support centralized review or not, device manufacturers want CMS to provide more detail on how the process would work – including timelines, the extent of manufacturer interactions with agency staff, and how appeals would be handled.

Some device companies say they generally support CMS’ proposal to centralize coverage review of investigational device exemption studies, while others want to retain the current Medicare Administrative Contractor-based coverage process. But virtually all industry stakeholders providing feedback to CMS say that if the agency does switch to centralized review, it must first offer a lot more detail about how the process would work.

For example, CMS should specify a timeline for its reviews, create a formal appeals process, and ensure that coverage determinations are communicated to MACs, Medtronic and Covidien wrote in separate comments to CMS on the proposal, which appeared in the agency’s 2014 proposed physician fee schedule. (See (Also see "CMS Proposes Centralized Review, New Standards For Reimbursement Of IDE Studies" - Medtech Insight, 9 Jul, 2013.).) Both companies expressed overall support for centralized review.

The two firms, joined by Abbott, AdvaMed and others, suggested a 30-day timeline for the centralized reviews. That timeframe would roughly align with the current performance of MACs, according to Covidien, which wrote that IDE coverage reviews by Medicare contractors typically range from one week to 30 days. Abbott, which urged CMS to retain the current decentralized review process, said that in its latest experience with a large U.S. investigational device exemption trial, the average turnaround time from submission to MAC coverage approval was 20 calendar days.

“A radical change in the coverage decision-making process for IDE trials may not be needed” – AdvaMed

While recommending a 30-day timeline, AdvaMed nevertheless expressed skepticism that CMS can perform the reviews in a timely and efficient manner, worrying that not enough resources and personnel will be allocated to the process. The trade group noted that the device industry conducts 150-250 IDE studies a year.

“Given current constraints on hiring within the federal government, reported CMS staff vacancies that are not being filled, and other budgetary considerations, we have serious concerns that CMS will have the resources to administer a centralized review process in a responsible manner,” AdvaMed said in its comments to CMS. Public comments on the physician fee schedule proposal were due Sept. 6.

Comments Urge CMS To Slow Down

AdvaMed suggested that rather than abruptly shifting to centralized review, CMS should assess whether refinements to the current process could help improve the consistency and efficiency of MAC-based IDE reviews. “A radical change in the coverage decision-making process for IDE trials may not be needed” and may in fact create obstacles that hinder research and reduce Medicare beneficiary access to IDE clinical trial participation, AdvaMed wrote.

CMS’ assessment should include broad consultation with manufacturers and the MACs and should include “a full analysis of the consequences and implementation challenges” of moving to centralized review. During the assessment, CMS should refrain from implementing the proposed shift, AdvaMed added.

In a similar vein, Medtronic recommended that CMS pilot the centralized review process prior to wide-scale implementation, much as the way FDA/CMS parallel review has been piloted. (See (Also see "FDA-CMS Parallel Review Saves Time, Clinical Trial Costs, Participant Says" - Medtech Insight, 1 Apr, 2013.).) Medtronic suggested that a pilot program include volunteer IDE trial applicants and open feedback from all relevant stakeholders.

“Centralizing reviews of IDE trials will require substantial resources and personnel,” Medtronic wrote. “Without piloting the program to identify strengths to leverage and weaknesses to improve on, CMS runs the risk of having to deal with glitches retrospectively.”

In the event that CMS goes ahead with centralized IDE coverage review, device firms asked the agency to explain what sorts of interactions sponsors will be allowed to have with CMS staff during the process. Abbott requested clarification that CMS will be willing to meet with sponsors before and during review to discuss the coverage application, and Medtronic requested a process for sponsors to answer CMS questions before the final coverage decision is made. Medtronic also recommended that CMS specify “an explicit point of contact on the review committee for sponsors to engage with about inquiries regarding trial applications.”

AdvaMed explained why such open lines of communication are essential. “In our experience, the coverage decision-making process for IDE trials demands a level of individual interaction and communication between the research sponsor and the Medicare medical director that does not appear to be built into the proposed new process. Questions might arise with respect to specific matters involving IRB approvals, or patient selection criteria, or the research protocol that demand timely and personal discussion,” the association commented. AdvaMed pointed out that under the current IDE coverage system, MAC medical directors are known to companies, familiar with researchers and research centers in their jurisdictions, and “generally reachable by investigators, sponsors and study center personnel.”

Finally, AdvaMed offered an alternative to CMS’ proposal – what it called a “limited” version of centralized review. Specifically, AdvaMed suggested that CMS explore creating a process whereby study sponsors could request a centralized coverage determination for IDE trials or studies of promising technologies that are noncovered by Medicare.

“This limited application of CMS’ centralized process proposal might permit direct discussions between CMS coverage staff and potential study sponsors apart from the timelines and procedures associated with the national coverage process, and it could serve as an adjunct to CMS evidence generation efforts through coverage with evidence development,” AdvaMed said.

Is MAC-based Process Really Broken?

In issuing its proposal two months ago, CMS justified a move to centralized review by saying that it would produce a more efficient process and “ensure that coverage of items and services in IDE studies and trials is uniform across Medicare administrative regions.”

But in comments, AdvaMed said that the local coverage decision-making process “has generally worked well over the years,” despite some inconsistences in coverage determinations across MACs. Progress toward more uniformity could be achieved “with increased CMS communication and instructions to contractors when problems become apparent, for example, with the conduct of large, multicenter IDE trials that span multiple contractor jurisdictions,” AdvaMed said.

And Abbott said that although the current MAC-based process is “intrinsically inefficient, burdensome and expensive for sponsors,” significant progress has been made over the past year, due in part to improved CMS and FDA staff communication with local Medicare contractors. “Given these recent improvements, we believe the current MAC-based process should be retained,” Abbott wrote.

Meanwhile, the Medical Device Manufacturers’ Association said its members were surprised by CMS’ characterization of the current IDE coverage review process as inefficient. “The overall experience in working with local contractors by the majority of MDMA members has been relatively positive and historically efficient,” the group said in its comments to CMS.

Saying that a centralized review process is not needed and expressing concern that CMS’ proposal contains no details on timelines, appeals or the decision-making process, MDMA stated that it could not support the proposal at this time.

Device firms also gave feedback on CMS’ proposed standards for which IDE studies can be covered. The proposal, also included in the draft physician fee schedule, lists 13 scientific and ethical standards and states that a study that meets all 13 and is also a pivotal trial with a superiority design will be automatically covered. AdvaMed and many individual device companies objected to this preference for superiority designs, saying in comments that CMS was overlooking the importance of other device trial designs and the quality of the evidence they can produce. (See (Also see "Superiority Standard? Groups Bristle At CMS’ Transcatheter Valve Trial Proposal" - Medtech Insight, 12 Mar, 2012.).)