If reimbursement is already available for a predicate device, a 510(k) clearance is most appropriate, because it is faster and more predictable, although it limits the potential for higher payment.
By contrast, a premarket approval could lead to higher reimbursement over the long term, but it requires more robust outcomes and economic data to drive new codes, expanded coverage, and improved payment, said attorney Stephen Terman of Olsson, Frank, Weeda, Terman, & Matz , and Gordon Schatz of Schatz Reimbursement Strategies, in a webinar hosted by FDAnews.
Manufacturers should position a product for reimbursement or seek higher reimbursement well in advance of a 510(k) or PMA submission. As a part of this effort, they should initiate discussions with doctors and other clinical investigators who can become credible “reimbursement champions” for a device with their specialty societies, CMS, and private payers.
Other tips for maximizing reimbursement include:
Terman cautioned that using an incorrect billing code for a procedure could open manufacturers, hospitals, and doctors to liability under the False Claims Act, if the Justice Department determines that the error was an attempt to generate a higher payment.
“It’s very important to stay 100 percent consistent with your FDA-approved labeling when you’re providing coding information,” he said.
Schatz said the Trump administration will seek to streamline the FDA’s approval process, but any changes probably will not result in higher reimbursement. However, now is a good time to ramp up FDA lobbying activities, because FDA employees might be more amenable to industry concerns during a Republican administration.