Industry Leadership Reasserts Commitment to Innovation

A packed meeting agenda and enthusiasm for maintaining the momentum of the past 15 years generated robust attendance at the MDMA Annual Meeting in Washington DC on May 17-18.

MDMA Chair Nancy Briefs (Smoothshapes, Inc.) kicked off the meeting May 17 by praising the "constant and determined efforts of a small group of dedicated individuals" who collectively "did what at one time seemed impossible: create a respected, influential voice of advocacy for smaller, entrepreneurial medical innovators that must be listened to by the government policymakers and legislators."

Highlights of this year’s program include:

MDMA Alumni Reminisce
Briefs and MDMA Executive Director Mark Leahey reviewed the entrepreneurial innovative medical technology community’s advancements in facilitating and streamlining FDA approval of life-saving technologies, its dramatic progress in forcing open the hospital supply market to small, entrepreneurial technology innovators, and its forward momentum in securing Medicare reimbursement for critical new technologies.

The association celebrated its 15th anniversary at the meeting by inviting a group of former MDMA Chairs and senior staff to reminisce about the association’s early days and achievements.

Founding MDMA Board Member and first Chairman, Tommy Thompson (NRG, Inc) said: "I never would have believed possible what we have been able to accomplish over the past 15 years."

Chris Chavez (Advanced Neuromodulation Systems) reminded MDMA members of the importance of maintaining relationships with legislators and policymakers. "When I first joined MDMA, I had no idea just how influential the leaders on Capitol Hill are to our daily ability to do our jobs, to run our companies." Chavez said that he now is committed to keeping in touch with congressional staff, "building trust and a reputation – even if I don’t happen to need anything right this minute."

Jeff Kimble, the organization’s first executive director, said that the challenges and opportunities facing the fledgling industry in 1992 offered him "the greatest job I’ve ever had in my life."

Mary Lacey Ruther, MDMA’s longest-tenured employee who held senior positions at FDA and CMS, congratulated MDMA’s "thoughtfulness and clarity in expressing its positions on the issues."

HHS Seeks MDMA Input on Gainsharing, User Fees
MDMA annual meeting attendees were exhorted to remain involved in the continuing legislative debate over funding for FDA’s regulatory activity under the Medical Device User Fee and Modernization Act (MDUFMA).

Craig Burton, Deputy Assistant Secretary for Legislation with the Department of Health and Human Services, said "the time is now" for the medical device industry to make its voice heard on the reauthorization of MDUFMA. "Congress must act to keep this program going, and time is short," he said. Congress needs to hear from you.

Burton also welcomed MDMA members’ continued input into the ongoing gainsharing demonstrations.

MDMA Executive Director, Mark Leahey, thanked Burton for HHS’ leadership in recognizing that current language being considered by Congress might limit innovation on promising technologies for pediatric use. "FDA already has sufficient authority to protect patients and ensure safety and effectiveness," Leahey said.

MDUFMA, FDA Issues Update
MDMA meeting attendees heard a discussion of pending FDA legislation and regulatory activities by David Dorsey, senior fellow of the Senate Health, Education, Labor and Pensions Committee, and Larry Kessler, ScD, director of FDA’s CDRH Office of Science and Engineering Laboratories.

Kessler told MDMA attendees that FDA is developing metrics and methods for tracing device post-marketing issues. “We also are committed to the development and implementation of a risk-communication strategy” and wants to streamline the agency’s inspection practices, including forging a cooperative agreement with Canadian compliance authorities.

Keynote Luncheon
CDRH Director Daniel Schultz, M.D., provided an update on the Center’s priorities for 2007 and beyond including the reauthorization of MDUFMA II and additional activities to promote the public health.


MDMA’s Efforts to Promote a Fair and Open Marketplace
MDMA annual meeting attendees were told that the association intends to work to "ensure that patients and physicians have access to the best products at the best price."
Executive Director Mark Leahey reminded attendees that as a result of the association’s tireless efforts, four congressional hearings have been held on GPO abuse of their safe harbor from the Medicare anti-kickback statute. Leahey expressed concerns with the supplier funded GPO model and called for an end to the legalization of kickbacks between suppliers and GPOs.

Seth Bloom, majority senior counsel of the Senate Judiciary Antitrust Subcommittee briefed MDMA members during a May 17th panel discussion.

MDMA also expressed concerns over certain gainsharing schemes that would provide incentives to physicians for utilizing particular brands or models of devices. Lisa Waters, Project Officer, Medicare Demonstrations/ Payment Policy Division with the Centers for Medicare and Medicaid Services (CMS), provided attendees with an update on the two gainsharing demonstrations under development.

The issue of health care representative vendor credentialing by hospitals was discussed by John Tara, Director, Corporate Strategic Marketing, Boston Scientific Corporation. This is an increasingly important issue to our members who are concerned about the costs and variation among programs.

MDMA Members Hit the Hill in Force
Attendees at the MDMA Annual Meeting took time May 17th to meet with congressional representatives, Senators and staff on a variety of issues confronting the entrepreneurial medical technology industry.

During the "Hill visits," MDMA members explored a number of issues, including:

• Repealing the GPO "safe harbor" from the Medicare anti-kickback statute;
  
• Ensuring that any patent reform legislation does not weaken IP for life science companies; and
  
• Swift passage of the MDUFMA II reauthorization
  

MDMA Focus on Compliance Issues
A panel of experts discussed recent trends in sales and marketing enforcement activities as well as discussed the MDMA Guidelines. Michael Bell, Of Counsel at Mintz Levin, provided an overview of the current compliance environment for MDMA Members. Jason Hannon, Senior Vice President and General Counsel at Nuvasive, discussed his company’s experience implementing the MDMA Guidelines. Don Zarin, Partner at Holland + Knight LLP, discussed recent activity in the Foreign Corrupt Practices Act (FCPA) arena.

MDMA attendees also heard from James Ravitz, Partner at Arent Fox LLP, on variety of compliance issues, including FDA.

Patent Issues
Les Bookoff, Partner at Finnegan Henderson Farabow Garrett & Dunner L.L.P, discussed strategies that medical technology companies can protect their IP.
Steve Jensen, Partner at Knobbe Martens Olson & Bear LLP talked about concerns with certain provisions on the Patent Reform Act of 2007 currently being considered by Congress, including post-grant review, apportionment of damages and expanding USPTO’s rule making authority.

Coverage and Payment Issues
MDMA concluded the meeting with a panel on coverage and payment issues and a keynote address from Herb Kuhn, CMS' Acting Deputy Administrator, who discussed CMS increasing its role as an "active purchaser" of health care.

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PHOTOS

Thursday 5.17.07

8:00-9:00 am

Registration and Continental Breakfast
Constitution CDE

9:00-9:15 am

Welcome and Opening Remarks
Constitution CDE

Mark B. Leahey, Esq., Executive Director, MDMA

Nancy Briefs, Chair, MDMA, President and CEO, SmoothShapes Inc.

Celebrating 15 Years of Achievement
Constitution CDE

Former MDMA Chairmen discuss the Association's impact in Washington

10:00-10:45 am

HHS Update
Constitution CDE

10:45-11:00 am

Break

11:00-12:15 pm

MDUFMA II, Unique Device Identification and Other FDA Issues
Constitution CDE

Panelists:

Larry Kessler, Sc.D., Director, Office of Science and Engineering Laboratories, CDRH, FDA

John Manthei, Partner, Latham and Watkins LLP

12:15-1:30 pm

Luncheon Keynote: CDRH Update
Constitution B

1:30-2:45 pm

Market Access: Ensuring Patient Access to Innovative Technologies, Update on GPO Reform, Gainsharing Demonstrations and Vendor Credentialing
Constitution CDE

GPO Reform
Seth Bloom, Majority Senior Counsel, Senate Judiciary Antitrust Subcommittee

Joe Kiani, Vice-Chair, MDMA, Chairman and CEO, Masimo Corporation

Gainsharing Demonstrations
Lisa R. Waters, Project Officer, Medicare Demonstrations/ Payment Policy Division, CMS

Vendor Credentialing
John Tara, Director, Corporate Strategic Marketing, Boston Scientific Corporation

2:45-3:00 pm

Preparing To Hit the Hill
Constitution CDE

3:30-5:30 pm

Congressional Fly-in
House and Senate Office Buildings

Conference participants attend Hill meetings with their respective Senators and Representative to discuss issues affecting the innovative medical technology industry.

5:30-7:00 pm

MDMA Chairman's Reception Honoring U.S. Representative Anna Eshoo (D-CA-14th)
Grand Hyatt, Independence H & I

MDMA will present Congresswoman Eshoo with the 2007 MDMA Chairman’s Award at a reception at the Grand Hyatt hotel. MDMA is honoring the Congresswoman for her long-time support of innovative entrepreneurial medical technology companies.

8:00-8:30 am

Registration and Continental Breakfast
Constitution CDE

MDMAGuidelines and Other Compliance Issues
Constitution CDE

Michael Bell, Esq., Of Counsel, Mintz Levin

10:00-11:30 am

A Comprehensive Look at Critical Business Issues Impacting Medical Technology Companies
Constitution CDE

Les Bookoff, Partner, Finnegan Henderson Farabow Garrett & Dunner L.L.P

James Ravitz, Esq., Partner, Arent Fox LLP

11:30-12:30 pm

Coverage and Payment Issues
Constitution CDE

12:30-1:45 pm

Luncheon Keynote: CMS Update
Constitution B

Herb Kuhn, Acting Deputy Administrator, CMS

1:45 pm

Closing Remarks
Constitution B

Mark B. Leahey, Esq., Executive Director, MDMA

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