Small Bone Innovations (SBi), Inc. acquired the Scandinavian Total Ankle Replacement System (STAR™ ankle) and utilized MCRA’s US regulatory team in 2009 to secure FDA PMA approval, which occurred on May 27, 2009. SBi challenges just began after PMA approval as at that time in 2009 only 30% of the commercially insured patients in the United States had access to total ankle replacement(1).This negative dynamic was due to poor historical outcomes with previous ankle replacement technologies, and lack of payer education and interests resulting in denial of coverage. MCRA did a wonderful job of utilizing our level-1 clinical data and performing a concerted effort with professional societies, technologies assessment organizations, regional payer-by-payer interactions, and pre-authorization services. MCRA worked closely with surgeons to facilitate changing society position statements, changing technology assessment guidelines, providing patient access, and working with insurance companies in providing coverage. MCRA communicated the cost benefits, clinically proven benefits and comparative effectiveness of STAR™, and expeditiously increased STAR’s™ reimbursement accessibility around the country. Less than two years later, STAR™ became 100% reimbursable around the United States, by both commercial and Government health insurance plans. Without MCRA, SBi would not have the critical access it needed to successfully provide world class products to the US population.
(1) Based on 2008 AHIP published policies.
ARTHREX, INC. CORPORATE COMPLIANCE OFFICER Having a dedicated coding and reimbursement “hotline” helps medical device manufacturers with compliance concerns and challenges by relieving the burden of calls being misdirected internally and provides standardized and up to date replies. The tracking records MCRA provides are much improved over what we were able to develop in-house. The quality of work and expertise MCRA provides is excellent. MCRA is very responsive to our needs and get back to me immediately with responses.
MCRA delivers professional, credentialed coding and reimbursement assistance when our clients need it most and follow-up our instructions when we have specific needs for new products, always remaining within the industry standards. MCRA is exceedingly reliable and responsive to our needs and current issues.