Define Terms Carefully to Avoid Medicare as Secondary Payer Rule

Medicare can provide coverage for injuries that occur during clinical trials, but sponsors should be careful about the language they use in informed consent documents to avoid triggering the Medicare as Second Payer (MSP) provisions, according to Ryan Meade, a partner with the law firm Meade and Roach. “As long as there’s not someone else out there, [Medicare will] pay for services during clinical trials, even nonqualified clinical trials,” Meade said. However, a variety of factors affecting clinical trials can trigger the MSP rule, leaving sponsors holding the bag for the cost of injuries and complications associated with a study.
Clinical Trials Advisor