Robert E. Wanerman, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Medtech Dive, in “CMS Floats New Add-On Payment Route for Breakthrough Devices,” by David Lim.

Following is an excerpt:

On a call with reporters, CMS Administrator Seema Verma said technology has the potential to save the healthcare system money, but Medicare’s current payment system provides limited access to new technologies.

“CMS requires evidence that devices represent a substantial clinical improvement for the devices to qualify for a new technology add-on payment. However, for new devices granted this expedited FDA approval real-world data regarding outcomes for the devices in different patient populations is often limited, often making it hard for innovators to meet the requirements,” Verma said.

In the proposed rule, CMS seeks feedback on the whether the new pathway will “facilitate beneficiary access to transformative new medical devices, including the benefits of mitigating potential delayed access to innovation and adoption, against any potential risks, such as the risk of adverse events or negative outcomes that might come to light later.” …

Verma emphasized​ that under the new proposal after the two-year period expires, to continue receiving add-on payments devices would have to show evidence of substantial clinical improvement. At the same time, the agency is considering updating what it considers a substantial improvement. …

Robert Wanerman, an attorney at Epstein Becker Green, told MedTech Dive that most private payers will probably not alter their reimbursement behavior significantly if the new policy goes into effect. But the proposal could benefit hospitals who often face challenges when deciding to utilize new technology to treat patients.

“This is not a radical shift for CMS, but it loosens up the program a bit. It makes it a little easier if you are a certain category of device for hospitals to adopt the new technology. The problem with the Medicare program for some time is that payment lags behind innovation,” Wanerman said.

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