New Service From Musculoskeletal Clinical Regulatory Advisers, LLC To Facilitate Reimbursement For Orthopedic Devices
Washington, DC - February 1, 2008 - Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), an orthopedic industry services firm, announced the introduction of a Reimbursement Management Center. Technologies recently cleared or approved for marketing by the United States Food and Drug Administration (FDA), that meet resistance from payors, may turn to MCRA for daily reimbursement support services.
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. Clearly, the ability to affect reimbursement pull-through has become an essential ingredient of success to any medical device company,” 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.”
About MCRA, LLC
MCRA (www.mcra.com) was founded in 2003 and provides “first-in-class” service to its clients through its superior knowledge base, global surgeon relationships and deeply experienced management team. The true value of MCRA is the integration of 5 business value creators – regulatory, reimbursement, clinical, intellectual property and quality assurance. MCRA places particular emphasis on working with companies at all stages of development, whether they are single-product companies or companies with several thousand technologies.
Contact:
David Lown, General Manager, MCRA, LLC
(212) 583-0250 ext. 2111
[email protected]




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