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Contacts: David Lown, General Manager MUSCULOSKELETAL CLINICAL REGULATORY ADVISERS, LLC MCRA Vice President of Reimbursement, Charles Schneider, said: “After FDA approval, many technologies can face significant challenges from insurance carriers who may deny or restrict coverage for new products. This places significant restrictions on their use and requires complex coding strategies that we are able to mitigate based on our experience in guiding companies through the reimbursement process.” In response to industry demand, MCRA will provide coding, coverage, and payment services to clients by working with physicians, hospitals, payors, regulators and other reimbursement stakeholders. Based in Washington, DC, MCRA’s Reimbursement Management Center will offer services such as client-specific, toll-free telephone numbers, product-specific coding recommendations, distribution of reimbursement guides and coding tools, claims assessments, payment research and related services. “Rising client demand for expert consulting services has naturally led to the development of the Reimbursement Management Center,” Schneider noted. “Our knowledge and experience in both the medical device and insurance payor perspectives, coupled with MCRA’s orthopedic acumen in existing and innovative medical technologies, should provide valuable assistance to manufacturers, care providers and payors by building clearer understanding of correct coding requirements,” he added. MCRA’s General Manager, David Lown, added: “The Reimbursement Management Center is a completely innovative service that, to our knowledge, is unavailable to manufacturers lacking the internal resources to perform the same tasks.” “MCRA’s reimbursement team has over 20 years of experience in deploying the management center business model within both the medical device and health insurance industries, enabling us to help the orthopedic industry more effectively to commercialize innovative technologies. MCRA is now positioned to affect reimbursement pull-through, while most consulting firms merely offer advice,” he said. MCRA support of product commercialization following FDA approval further adds to the integrated consulting strategy offered by the firm. MCRA’s Vice President of Regulatory Affairs, Glenn Stiegman, said; “FDA approval does not guarantee reimbursement for technologies regardless of their efficacy within clinical trials. It is imperative that regulatory, clinical, quality assurance and reimbursement professionals work together to form a unified vision of what it takes to commercialize a technology.”
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