Include Payers in Your Product Development and Clinical Use Processes.

Wound/ulcer management scientists, researchers, manufacturers, professionals, and providers cannot assume that clearance or approval by the Food and Drug Administration (FDA) will guarantee reimbursement for medical devices they develop or wish to use in their practices. Even if a relative code and a published payment rate for the code exist, if the payers do not provide coverage for the technology, the devices may not be able to be sold and used in all settings throughout the continuum of care. Unfortunately, reimbursement (particularly coverage) is often an after-thought once FDA clearance or approval is achieved. This article describes two new Medicare coverage processes that should encourage all stakeholders to educate payers early and often why important medical devices should be covered for their patients with wounds/ulcers.