History of MDMA

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

2008

Worked with stakeholders to stop enactment of dangerous patent reform provisions on apportionment of damages and post-grant review; successfully advocated CMS to address charge compression in the IPPS and OPPS

2009

Urged Congress to examine practices of group purchasing organizations; Advocated Congress to minimize impact of health care reform on the medical device industry; Created working group focused on international issues

Future Direction

In 2010, MDMA will focus its advocacy efforts on improving the legislative and regulatory environment for medical technology innovators.  The four primary platforms of MDMA’s 2010 Public Policy Agenda include: minimizing the impact of the health care reform and advocating for the removal of the medical device tax; preserving strong intellectual property laws which promote innovation; ensuring patients and caregivers have open access to innovative technologies that are safe and effective through a predictable FDA process; and improving the Medicare coverage, coding and payment processes to promote timely and adequate reimbursement for innovative technology.