The personalized medicine industry faces particular challenges associated with securing payer coverage and reimbursement. Many payers currently do not support treatments or genetic testing that cannot be demonstrated to be medically necessary for the diagnosis or treatment of existing medical conditions, despite the growing recognition and acceptance that both patient and payer benefit from avoiding expensive medical conditions when possible. For payers that may be able to provide reimbursement, it will be important to establish the clinical benefits (and potentially lessened therapeutic costs) of the particular product. In some cases, payers will require as a condition of coverage that there be adequate demonstrations of favorable results specific to a particular population, dictating that clinical trials are designed to produce the evidence that can subsequently demonstrate clinical efficacy for that population. There are several governmental agencies studying the development of regulatory standards for tests, coverage, and reimbursement. In light of the government’s health care reform efforts, it will be important to monitor and understand these efforts for their ultimate impact on reimbursement.
Our Personalized Medicine Practice includes former assistant U.S. attorneys and federal regulatory attorneys who previously were responsible for the oversight of Medicare and other government program reimbursements for tests and treatments. Drawing on this experience, we can counsel you on the development and implementation of business strategies that can optimize reimbursement opportunities by both government and private payers. In addition, with significant experience in payer coverage and reimbursement rules, including the reimbursement and compliance requirements for clinical trials, we can provide you with seamless services throughout your product life cycle, from product concept to payment.