NEW YORK--(BUSINESS WIRE)-- Small Bone Innovations, Inc. (SBi) announced today that the 2.9 million members of EmblemHealth’s Health Insurance Plan of New York (HIP) and Group Health Incorporated plans in the New York tri-state region will gain access to the company’s STAR™ total ankle replacement system. The decision means that 99 percent of all privately insured lives in New York State will have access to total ankle replacement.
The STAR ankle is the only total ankle replacement system cleared through the U.S. Food and Drug Administration’s (FDA) rigorous Premarket Approval (PMA) process.
EmblemHealth’s policy change extends STAR ankle coverage to more than 95 percent or approximately 165 million of all privately insured health plan members in the U.S. This includes major private insurers such as all Blue Cross and Blue Shield Association member companies, Aetna, CIGNA, Coventry, WellPoint, Tufts, Health Net and others.
Almost all of the 100 million eligible individuals covered by governmental insurance programs, such as Medicare, Medicaid and TRICARE, also provide access to the STAR ankle, as well as most individuals covered by state workers' compensation programs.
Since SBi’s reimbursement consultant, Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), launched a program in late 2009 to communicate clinically proven benefits, comparative effectiveness and overall cost benefits of the STAR ankle, most insurers have revised their policies to provide coverage for an aggregate total of 265 million insured lives.
In the PMA process, the STAR ankle’s safety and effectiveness was compared with ankle fusion in a multi-center, multi-year, Investigational Device Exemption (IDE) study. The study results, published in 2009, supported the only PMA approval order ever to be issued by the FDA for a total ankle joint replacement - demonstrating the STAR to be superior in efficacy and comparable in safety to fusion. The IDE and other study results also showed that the STAR ankle had better pain relief, greater clinical success, less blood loss and a shorter operating time than fusion.
Steven C. Sheskier, MD, a foot and ankle specialist in the Department of Orthopaedic Surgery at the NYU Hospital for Joint Diseases, said: “The STAR ankle is a highly desirable alternative to fusing ankles affected by mid to late stage arthritis. It represents a quantum leap in the treatment of the painful arthritic ankle that is being recognized by insurers as an efficient, cost effective way to restore joint function and eliminate pain.”
About Small Bone Innovations, Inc.
Small Bone Innovations, Inc. (SBi) was founded in 2004 by Viscogliosi Brothers, LLC (VB), the New York-based merchant banking firm that specializes in the musculoskeletal/orthopedics sector. SBi was the first company to focus purely on small bones & joints by integrating established companies and professionals in the field. It offers a broad, clinically proven portfolio of products and technologies to treat trauma and diseases in the small bones & joints.
SBi has facilities in New York, NY, Morrisville, PA, Péronnas, France, Donaueschingen, Germany, and Kuala Lumpur, Malaysia and has sold its products in 46 countries. For a notice on Forward Looking Statements and more information about SBi, please visit: http://www.totalsmallbone.com/us/press.php4.
Small Bone Innovations, Inc.
Varun Gandhi, 212-583-0370, ext. 2126
KEYWORDS: United States North America New York
INDUSTRY KEYWORDS: Surgery Health Clinical Trials Hospitals Medical Devices Professional Services Insurance Managed Care