MDMA's HISTORY
MDMA was created in 1992 by a group of medical-device company executives who believed that the innovative and entrepreneurial sector of the industry needed a strong and independent voice in the nation's capital. Since its inception, MDMA can claim credit for a number of policy achievements, from the defeat of legislative proposals to foist "user fees" upon the industry in 1993 and 1994 to the development and passage of the landmark FDA Modernization Act of 1997.
1992 Founded by a group of medical device manufacturers who realized the interests of small companies were not represented in Washington
1994 Testified before Congress and led industry effort to convince Congress to abandon The Medical Device User Fee Act of 1994
1997 Played a leading role in the development and passage of The FDA Modernization Act (FDAMA); MDMA hosts First Annual Coverage and Reimbursement Conference
1999 MDMA lobbied to assure that new and innovative medical devices can be separately reimbursed through “Pass-Through” and “New Technology” vehicles in the OPPS
2002 Successfully lobbied for small business discounts and greater oversight of reused single use devices under The Medical Device User Fee and Modernization Act; Testified before Congress on anticompetitive practices of hospital group purchasing organizations (GPOs)
2003 Passage of The Medicare Prescription Drug, Improvement, and Modernization Act (MMA) which provided a mechanism for New Technology Add-on payments for innovative technologies under IPPS
2004 The Medical Device Competition Act of 2004 introduced to reform GPO industry; Successfully lobbied for passage of The American Jobs Creation Act
2005 Passage of legislation which increased the MDUFMA small business threshold to $100M in annual revenues; Successfully prevented the require-ment that CPT code applications be required for applications for New Technology or Pass-Through
2006 Actively lobbied against certain “gainsharing” schemes; Prevented significant reimbursement cuts under IPPS; Advocated for implementation of ICD-10; and testified before Congress calling for an end to GPO kickbacks
2007 Passage of The FDA Amendments Act (FDAAA) provided greater user fee relief and created an interactive premarket review process; lobbied to improve Patent Reform Act provisions which would have weakened the patent
Future Direction
MDMA is currently building on its achievements and reputation by extending the association's influence into new areas and by leveraging the combined resources of its members into new and improved services for member companies.
For instance, MDMA is leading national efforts this year to address the reimbursement issues that vex our membership. We are working with the federal Centers for Medicare & Medicaid Services (CMS, formerly HCFA) toward developing technology-assessment processes and standards for the Medicare program that are open, rational, flexible, and accountable. We are also encouraging CMS, insurance companies, and managed-care organizations to support the process of technological innovation.
MDMA's website is a valuable information resource for members and the general public. MDMA is constantly enhancing its membership services and developing new member benefits. MDMA members will also receive weekly, monthly and quarterly updates and policy analyses. By facilitating interaction with our membership, and between our membership and Washington, MDMA is contributing to its members' productivity and adding value to membership.