History of MDMA
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.
Today, MDMA is the leading voice representing the interests of innovative and entrepreneurial medical technology companies. We provide educational and advocacy assistance to more than 270 members. MDMA members all share a common goal: to provide patients and clinicians with timely access to safe and effective medical technologies that improve the quality of life.
This is accomplished by maintaining relationships with key Members of Congress, senior staff at FDA and CMS, and through the grassroots support of our members.
In 2011, MDMA will focus its advocacy efforts on improving the legislative and regulatory environment for medical technology innovators. The four primary platforms of MDMA’s 2011 Public Policy Agenda include: ensuring that a reasonable and predictable regulatory pathway exists for innovative devices and technologies to gain access to the market; work on addressing the most problematic elements of the Accountable Care Act, including the repeal of the medical device tax; preserving strong intellectual property laws which promote innovation; and improving the Medicare coverage, coding and payment processes to promote timely and adequate reimbursement for innovative technology.
Led the fight to oppose the medical device tax from the outset, and though unsuccessful in eliminating it, cut the tax in half and continued to work for a full repeal; worked to shape comparative effectiveness research to focus on "clinical effectiveness", not "cost-effectiveness"; engaged FDA leadership, Congress and the IOM on the need for a more predictable, reasonable and transparent premarket review process for medical devices; created an alliance with more than a dozen state and regional based groups throughout the country to harness the collective efforts of the med-tech community; and organized powerful studies and surveys that are being used to educate elected officials and policy makers, as well as the public on key issues.
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.
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.
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.
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.
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.
The Medical Device Competition Act of 2004 introduced to reform GPO industry; Successfully lobbied for passage of The American Jobs Creation Act.
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.
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).
MDMA lobbied to assure that new and innovative medical devices can be separately reimbursed through “Pass-Through” and “New Technology” vehicles in the OPPS.
Played a leading role in the development and passage of The FDA Modernization Act (FDAMA); MDMA hosts First Annual Coverage and Reimbursement Conference.
Testified before Congress and led industry effort to convince Congress to abandon The Medical Device User Fee Act of 1994
Founded by a group of medical device manufacturers who realized the interests of small companies were not represented in Washington.