Robert E. Wanerman, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in FDA Week, in “Device Makers Praise Bipartisan Device Coverage Bill, But Issues Remain,” by David Roza.

Following is an excerpt:

The medical device lobby praised a newly introduced bipartisan House bill that would require CMS automatically cover for three years breakthrough devices approved through FDA’s expedited review pathway, but an industry lawyer said lingering questions could cause some manufacturers to be wary of the new process were the bill to be passed unchanged. The lawyer said it is unclear whether manufacturers would need to apply for the bill’s transitional coverage, what data CMS would require for a final national coverage determination; and specifically how reimbursement levels would be set for the new technology during the transitional period.

“There are numerous manufacturers that don’t want to gamble on an unfair national coverage determination, so they might stay away from that process or wait a long time,” said Robert Wanerman, a member of the Health Care and Life Sciences practice at Epstein Becker Green. “If you get into this program and get Medicare coverage [for three years] it’s great, but what happens at the end of that period? At the end, CMS could still make a negative national coverage determination.” …

Wanerman said the bipartisan bill is a step forward for device makers but still leaves some key issues unclear.

For example, he said it is unclear whether manufacturers would have to ask CMS to enter the bill’s transitional coverage period or whether CMS would take the initiative on starting the process.

“Reading that part, I’m not sure if this is something CMS does on their own initiative or if the manufacturer has to ask for it,” Wanerman said. “That’s not clear in the bill and that’s an important consideration for manufacturers.”

Wanerman also said it is uncertain what type of data CMS would look for in making its coverage determination.

While the bill does call for new medical services or technology to meet criteria such as reducing hospital stays, improving patient quality of life, or decreasing pain, bleeding or other symptoms, the lawyer said the exact requirements for meeting those criteria remain unknown.

“CMS is going to be looking for evidence of improved outcomes,” he said. “But then is it a question of improved outcomes or improved outcomes over what timeframe? That’s not specified here.”

Wanerman also said manufacturers would have to show particularly good outcomes with older patients in order to win coverage from Medicare. “If you don’t have great numbers with the Medicare population, like over 65, there’s a real risk there and lots of manufacturers know that,” he said. “Some manufacturers might think this is very nice, but they’re still gambling and they would rather go a more traditional route.”

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