MDMA Celebrates 15 Years: Past Achievements and Looking Ahead
BY LAUREN UZDIENSKI, MAY 21, 2007
Last week's Medical Device Manufacturers Association Annual Meeting in Washington, D.C. gave us an opportunity to applaud the passion and dedication that defined MDMA's past accomplishments and will carry future negotiations on regulatory, reimbusement and marketplace issues for smaller device companies.
We heard from a number of FDA and CMS officials as well as past chairmen of MDMA, consultants, lawyers and manufacturers. Some of the highlights included:
A Visit from Past Chairmen
To kick off the presentations, current Executive Director Mark Leahey interviewed a panel of past chairmen about their experiences with MDUFMA I (a 1994 FDA user fee act was the first principle around which MDMA rallied), reimbursement and GPOs, early experiences that would define the lobby's mission, commitment and expertise. The panel reinforced the value of MDMA and all the work they do amid the complicated, crowded Capitol Hill climate - as candidly summed up by Jeffrey Kimball, former MDMA chairman and President of Jeffrey J. Kimball & Associates, "The number of people [on the Hill] who know the difference between 510(k)s and their 401(k)s is probably five." The importance of MDMA's voice is all the more clear.
Working with FDA
MDUFMA I shaped the early days of MDMA; the lobby also participated in the reauthorization process of MDUFMA II. MDMA's recommendations, which were born out in the proposed legislation, emphasized a predictable fee structure as well as discounted fees for small businesses, transparency in interactions with FDA and performances goals for the agency (including target 510(k) and PMA review times), among other points.
Reimbursement Trends
We've heard it before: evidence, evidence, evidence. Steve Phurrough, CMS's Director of Coverage and Analysis, focused on good data (randomized controlled trials) and generalizable evidence, alluding to the no coverage decision for the Charite disc and its lack of generalizable evidence. Point taken, and a private payer consultant also stood behind the merits of strong evidence in support of coverage. Liz Richter of CMS reviewed proposed changes to the IPPS rule, describing the addition of severity-related DRGs and ongoing research into charge compression. CMS is currently welcoming comments on the proposed rule.
Marketplace Concerns
Two gainsharing demonstrations are in the works at CMS, one small effort comprised of six hospitals (two rural) and a second larger in scope, with 72 hospitals. A timeline for the demos wasn't discussed, but we'll be watching for developments.
Not much has changed on the GPO front, but the discussion had enthusiastic speakers - Joe Kiani of Masimo, a pulse oximeter manufacturer that won $420 million in damages in an antitrust case with Tyco, and Seth Bloom of the Senate Judiciary Antitrust Committee. Mr. Bloom discussed possibilities for reform, but the voice from the audience was clear - repeal the GPO Safe Harbor.
Other talks covered IP law, issues in labeling and promoting devices and developing trends such as unique device identification and industry rep credentialing. The meeting was tremendously informative, and we celebrate with MDMA in their accomplishments over the past 15 years. MDMA's commitment, knowledge and tireless efforts are values we're happy to stand behind.
