The successful launch and sale of a health care product or service depends largely on the availability of adequate Medicare, Medicaid, and third-party payer coverage and reimbursement. Whether a product or service is a state-of-the-art emerging technology or considered an established standard of care, Arent Fox attorneys have the experience to develop and implement local and national strategies to champion new reimbursement and to address existing coverage and payment inequities. We work with clients to ensure that clinical trials are designed to collect data critical to address the safety and efficacy standards for FDA approval as well as the medical necessity standards of payers. We also assist clients determine the most advantageous regulatory approval strategy to position a product for third-party reimbursement.
