Robert E. Wanerman, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Bloomberg News, in “Trump Might Pay for Some Devices Before Medicare Approval: Industry,” by Jacquie Lee.

Following is an excerpt:

The Trump administration appears willing to temporarily pay medical device companies for novel devices while they collect the necessary data to get approval for Medicare coverage, industry group AdvaMed’s CEO said.

Companies have to prove their devices are effective to be placed on the Centers for Medicare & Medicaid Services’ reimbursement list, but getting those data takes time and money. Delays in reimbursement are the primary reason companies delay or decline to invest in breakthrough medical devices, Scott Whitaker, the head of AdvaMed, told reporters Sept. 24 at the MedTech conference in Philadelphia. …

AdvaMed was behind a bill introduced in June (H.R. 5997) by Rep. Suzan DelBene (D-Wash.) that would automatically transfer devices classified by the FDA as breakthrough into a program where the CMS would temporarily cover the product for up to three years. Reimbursement would depend on the type of technology, but devices that cost more to produce would theoretically get a higher reimbursement rate, Don May, AdvaMed’s executive vice present of payment and health-care delivery policy, told Bloomberg Law. That bill was referred to a House health subcommittee in June. …

Whitaker’s proposal sounds like an expansion of the CMS’s coverage with evidence development program, which helps companies cover some costs related to clinical trials, Robert Wanerman, a partner at Epstein Becker & Green in Washington, told Bloomberg Law.

For example, a person enrolled in a clinical trial might need to have surgery to have the new device that’s being tested implanted. The CMS would cover the cost of that surgery under the coverage with evidence program.

Whitaker’s expansion “sounds good at first blush,” Wanerman said, but getting the CMS involved in a device’s early data-gathering process has substantial risks for companies.

“If the data isn’t good then it’s disastrous for that product and company,” said Wanerman, who specializes in CMS regulatory issues, particularly for medical devices. Companies are aware a negative decision from the CMS “is bad for their Medicare business, but can ripple through it’s other businesses as well,” like with private insurance plans, he said.

Wanerman anticipates device makers with lower-risk devices—those that require minor surgery to implant or small health risks—would be more likely to utilize the proposed reimbursement program.

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