FIRMS SHOULD BUILD REIMBURSEMENT STRATEGIES INTO PRODUCT DEVELOPMENT
Every devicemaker should include a reimbursement strategy in the early stages of device development to ensure the viability of its products, experts said Oct. 18 at the annual Regulatory Affairs Professionals Society conference.
Industry regulatory professionals spend most of their efforts getting products approved by the FDA, but that is only one step, said Gordon Schatz, a partner with the law firm Reed Smith. Without a mechanism in place to make sure they are paid for, devices "can fall into the desert of the dry reimbursement world," he said.
Whether a devicemaker's products fit into the coverage categories of the Centers for Medicare & Medicaid Services (CMS) can affect the company's success, because that agency is the largest single payer in the U.S.
Firms need to understand the difference between the FDA and CMS approval processes, said Steve Phurrough, director of the CMS' coverage and analysis group. The FDA is focused on whether a product is "safe and effective," while the CMS is focused on whether a procedure -- and, therefore, the device used in it -- is "reasonable and necessary," he said.