The goal of creating a predictable, quicker path to reimbursement for so-called breakthrough technologies that address unmet needs is increasingly on the minds of not only industry leaders, but top brass at FDA and the Centers for Medicare & Medicaid Services, as well.

Multiple executives at the AdvaMed 2015 conference in San Diego repeated the statistic that it was 20-times more difficult to get a positive coverage decision for a breakthrough technology now than it was a decade ago. Industry representatives are currently in discussions with CMS to figure out a plan to reverse that trend.

In particular, companies say they are pushing for similar improvements at CMS to what many believe are happening at FDA, citing quicker reviews as a result of the current user fee program and development of the recently launched Expedited Access Pathway (EAP) program, among other reforms.

"We encourage CMS to take a cue from FDA and implement similarly impactful reforms and efficiencies to help support investment, innovation and timely patient access," outgoing AdvaMed CEO Steve Ubl said during an Oct. 5 press conference.

CDRH Director Jeff Shuren floated the concept of a "presumption" of coverage-with-evidence development following approval if a device qualifies for the Expedited Access Pathway and meets other CMS-set standards.

It is clear that FDA and CMS officials are talking with each other about the issue. At an Oct. 6 panel discussion at AdvaMed, FDA device center chief Jeffrey Shuren and CMS' Tamara Syrek Jensen, who leads the Medicare Coverage and Analysis Group, appeared to be improvising a bit to come up with a solution.

Presumption Of CED?

At the panel session, which focused on the challenges of balancing regulatory and reimbursement needs for device firms, Shuren floated a proposal to Jensen and the industry audience: CMS could identify a set of standards that, when met by a sponsor during the FDA premarket development process, would automatically qualify a new technology for a "presumption" of at least a coverage-with-evidence-development policy following FDA approval.

"If you then met those expectations ... that would be enough, and that is a way of providing more predictability by at least getting at minimum a CED," Shuren proposed. Under CED, a service is nationally covered by Medicare under the condition that additional evidence is collected either through a registry or clinical trial.

The standards would likely align closely with the strict entry requirements for the device center's EAP program, but there could be additional standards needed to meet presumed CED status.

To qualify for the EAP program, companies must show that its investigational device addresses a life-threatening or irreversibly debilitating disease, and offers big advantages over alternatives. The firms must also submit a detailed data development plan to support safety and effectiveness. As part of EAP, the sponsor gets early, intensive interaction opportunities with FDA reviewers and the potential to shift some data requirements into the postmarket phase. (See [A#01150413013].)

"We are working with them on a regular basis to try to unlock this and unwind it element by element, and try to find solutions," CVRx's Nadim Yared says.

Shuren emphasized that FDA is not getting into the reimbursement business; rather, it would simply be applying CMS-set standards that "naturally align with things we would otherwise look at" as part of its premarket review process.

CMS would make the final call whether to actually grant CED, or unconditioned coverage, and would determine payment amounts as usual, he said. He said the plan would parallel FDA's current practice for devices being evaluated in investigational device exemption trials where the agency assigns all investigational devices to either Category A (experimental) or Category B (non-experimental), which determines whether the device will be directly covered by Medicare as part of the trial.

CMS' Jensen responded positively to the idea, but cautioned that she had only heard about it for the first time five minutes before the panel began.

"It's not a bad idea," she told "The Gray Sheet," although she noted that it would need to be limited to only technologies that would be expected to have a significant impact on care in a large population.

During the panel discussion, she suggested that products approved via the EAP route would almost always have to be limited to CED rather than unconditioned coverage, particularly if part of the data collection had been shifted to the postmarket side.

Establishing a process that would add more predictability in reimbursement for certain big-ticket devices might be " an appropriate compromise to spur innovation, to put investment in innovation," Jensen said, "knowing that eventually we are going to have to come up with a 'yes' or 'no,' so you will have to follow through with all of that, and you will have to collect the data … or you don’t get paid."

Talks Ongoing

Both Shuren and Jensen emphasized that it was just an idea up for discussion and they hoped to get industry feedback.

One executive that is closely involved in ongoing discussions with CMS on this topic is Nadim Yared, CEO of privately held CVRx and chairman of AdvaMed Accel, which focuses on emerging growth company policy needs.

"We are working with them on a regular basis to try to unlock this and unwind it element by element, and try to find solutions," Yared said in an interview. (See [A#01151012005].)

Right now, AdvaMed is trying to push for a policy where devices that are designated as breakthrough technologies by FDA, such as under the EAP program, would automatically receive Medicare coverage for a period of three years. During that time, companies could collect evidence, Yared said. However, no agreement has been reached.

AdvaMed is pushing a similar plan on Capitol Hill, but was unable to get reimbursement provisions for breakthrough devices into the 21st Century Cures legislation, passed earlier this year in the House. That happened primarily because of jurisdictional challenges – that is, the bill came through the House Energy and Commerce Committee, which does not oversee Medicare. The device trade group has not given up on the legislative option, but leaders say CMS can make adjustments administratively.

One underlying challenge is the significant lack of resources at CMS' coverage office. Shuren's presumption-of-a-CED proposal was presented partially to address that challenge by shifting some analysis efforts away from CMS and into FDA.

Industry leaders also say they are acutely aware of the lack of manpower at CMS, which plays into their proposals as well.

"Knowing that CMS does not have anywhere near the resources that FDA has, why duplicate resources?" CVRx's Yared said. "Why not let CMS use the results of an analysis that FDA has done about whether there is an unmet clinical need or not. And then let CMS define what is reasonable, and how to get there, and get some relief for those companies to develop the evidence."

Overemphasizing National Coverage?

Another complication to the ongoing discussion is an emphasis on, specifically, the national Medicare coverage process.

The idea of directly linking CED policy with FDA approval through the EAP program presumes that the device in question will be subject to a national coverage determination (NCD). But NCDs are not appropriate for all technologies, said Lakshman Ramamurthy, VP, Avalere Health.

It is important to ask: "What is another mechanism that we could create that allows for appropriate data collection without some of the challenges that an NCD brings?" Edwards Lifesciences' Perry Bridger says.

"I think this is really just a slice of the pie," Ramamurthy, who moderated the AdvaMed panel with Shuren and Jensen, said in an interview.

Device firms have long been wary of the national coverage process because it threatens to limit flexibility in early stage adoption of a new technology by blocking local contractors from trying out different coverage policies. (See Also see "Parallel Reviews Should Lead To Local Coverage, Coding Decisions, Firms Say" - Medtech Insight, 3 January, 2011..)

The initiation or suggestion of an NCD by CMS triggers caution among local contractors, affirmed Perry Bridger, VP of reimbursement and public policy for Edwards Lifesciences, during the Oct. 6 panel discussion.

The contractors "may interpret the agency's initiation of an NCD as a signal that they have questions about the reasonable-and-necessary-ness of this technology," Bridger said. The NCD "introduces a level of uncertainty that has caused decisions at the local level that have impeded access."

As part of the process of determining an improved reimbursement pathway for breakthrough devices, "we have to think about this issue of which technologies, services or procedures will be taken up in CED," Bridger said. CED, which comes with proscribed steps and timelines, might not always be the best approach to ensure rigorous data is collected for a reimbursed device, he added.

It is important to ask: "What is another mechanism that we could create that allows for appropriate data collection without some of the challenges that an NCD brings?" Bridger said.

Breakthrough Reimbursement Proposals Percolate From FDA, Industry

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