| CONFERENCE RECAP |
MDMA hosted its 12th Annual Meeting on June 14th and 15th at the Mandarin Oriental hotel in Washington, D.C. With more than 140 attendees and a host of distinguished speakers, it was MDMA’s most successful annual meeting to date. MDMA Chair Nancy Briefs, CEO of Percardia, Inc., reminded attendees of MDMA’s advocacy successes. “This organization began with just a small handful of entrepreneurial companies and a common mission: to advocate for innovation to improve patient care,” she said. “Today, we are a strong voice in Washington.”
Highlights of this year’s program included:
A new study unveiled during the meeting showed how the nation’s hospitals collectively could save nearly five billion dollars if hospital Group Purchasing Organizations (GPOs) lost their safe harbor protection under the Medicare anti-kickback statute. Hal Singer, Ph.D., president of the economic consulting firm Criterion Economics, developed the study. He told MDMA that if GPOs – which purport to save the health care system money through volume purchasing on behalf of groups of hospitals – no longer were permitted to collect fees from dominant suppliers in exchange for market exclusivity, Medicare could save $2.5 billion annually.
The safe harbor, which was enacted by Congress in the 1980s, exempts GPOs from criminal penalties for accepting kickbacks from health care suppliers. The Senate Judiciary Antitrust Subcommittee has been investigating allegations of anticompetitive conduct and conflicts of interest by GPOs and is contemplating legislation, including repeal of the safe harbor.
MDMA Executive Director Mark Leahey commented: “The study demonstrates that GPOs cannot serve two masters. If the GPOs are to save money for hospitals and the health care system, and help assure delivery of high quality medical technologies to patients, they cannot be compensated by their suppliers.”
FDA Acting Commissioner Andrew von Eschenbach, M.D., pledged that the agency will “facilitate, not simply regulate” medical innovation. The FDA chief told MDMA attendees the agency is “strategically placed between the world of discovery and the world of delivery -- to not simply alleviate disease but also to improve overall health.”
FDA Center for Devices and Radiological Health Director Daniel Schultz, M.D., told conference attendees that publishing FDA’s long-awaited guidance on premarket approval supplements is “first on my to-do list.” He also said the agency wants to “work with our foreign counterparts to advance joint inspections and streamline standards.”
Senior staff members of the Senate Health, Education Labor and Pensions Committee explored the implications of funding shortages on FDA’s ability to reliably implement the Medical Device User Fee & Modernization Act (MDUFMA). A Democratic staffer and a Republican staffer both cautioned MDMA attendees that budget constraints likely preclude additional funding for MDUFMA.
The Centers for Medicare and Medicaid Services previewed its emerging pilot program to examine the impact of gainsharing, in which hospitals and physicians share the savings generated by reducing the costs of delivering health care. Mark Wynn, Ph.D., director of CMS’ Payment Policy Demonstrations Division told MDMA that his agency will soon issue “requests for proposals” to conduct the pilot program. Andrew Imparato, president of the American Association of People with Disabilities, warned of gainsharing’s potentially serious consequences for disabled patients and urged CMS to “proceed cautiously.”
MDMA’s Leahey said the association strongly will oppose any CMS pilot that encourages the standardization of products. “There is no such thing as a one-size-fits-all approach to medicine,” Leahey said. In response, Wynn assured the MDMA audience that the agency’s focus is not on a gainsharing structure that offers incentives to physicians in exchange for using a specific brand or product.
In addition to the host of high-level speakers and informative presentations on Wednesday, association members voted unanimously to approve two new members to the MDMA Board of Directors: Alex Lukianov, Chairman and CEO of NuVasive, San Diego, CA and Jo Ellen Slurzburg, Vice President, Reimbursement and Health Policy for Almyra Inc., in Boxborough, MA.
During the meeting, MDMA members also visited their respective Members of Congress to discuss important issues.
During a reception on Capitol Hill on Wednesday evening, MDMA presented its annual Chairman’s Award for dedication to improved health care through innovation to U.S. Senator Michael B. Enzi (R-WY). Enzi, Chairman of the Senate Health, Education, Labor and Pensions Committee, received the award for his long-time support of innovative entrepreneurial medical technology companies and his help with passage of the Medical Device User Fee Stabilization Act of 2005. Enzi thanked MDMA and the device industry – particularly small businesses – for their dedication to the American patient, and for helping to advance science and technology while creating jobs.
On Thursday, in a discussion of Medicare payment issues, Tom Gustafson, Deputy Director of the CMS Center for Medicare Management, reviewed the agency’s proposal to update the Inpatient Prospective Payment System. MDMA Board Member Jo Ellen Slurzberg (Vice President for Reimbursement & Health Policy, Almyra, Inc.) urged CMS to delay implementation of the rule until 2010. Speaking on behalf of MDMA, Slurzberg said the CMS rule “doesn’t seem to recognize the complexity of procedures that use advanced medical devices,” and asserted that the agency is relying on outdated cost report data in making assumptions.” MDMA has recommended that CMS maintain a charge-based system and delay implementation of the proposed shift to cost-based weights and severity-adjusted diagnosis-related groups (DRGs) that incorporate the complexity of care, particularly for device-dependent DRGs until 2010.
Wrapping up the two-day event was CMS Administrator Dr. Mark McClellan. Dr. McClellan said medical device innovators should be able to rely on a Medicare program environment that is “clear and predictable,” and that “payment for the use of devices should reflect true value.” McClellan also pledged that the agency’s gainsharing demonstration program would focus on a “broad approach to improving the quality of care” rather on specific incentive relationships between hospitals and physicians. MDMA has urged the agency to avoid considering gainsharing schemes that impose or encourage product standardization as a way to reduce health care costs.
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| PHOTOS |
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AGENDA |
WEDNESDAY 6.14.06 |
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8:00-9:00 am |
Registration and Continental Breakfast
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9:00-9:20 am |
Welcome and Opening Remarks
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Mark B. Leahey, Esq., Executive Director, MDMA
Nancy Briefs, Chair, MDMA, President and CEO, Percardia Inc |
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9:20-10:00 am |
FDA Commissioner's Update
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Andrew von Eschenbach, MD, Acting Commissioner, FDA |
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10:00-10:10 am |
Break |
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10:10-10:45 am |
CDRH Director's Briefing
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Daniel G. Schultz, MD, Director, CDRH |
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10:45-11:30 am |
MDUFMA and Other FDA Issues: Insights from FDA, Congress, and Industry
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Panelists:
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David Dorsey, Senior Fellow, Senate Committee on Health, Education, Labor and Pensions |
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Amy Muhlberg, Professional Staff Member, Senate Committee on Health, Education, Labor and Pensions |
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Moderator: |
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John Manthei, Partner, Latham and Watkins LLP |
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11:30-12:30 pm |
Gainsharing: An In-depth Look at this Critical Issue
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Panelists: |
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Mark Wynn, PhD, Director, Division of Payment Policy Demonstrations, CMS |
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Andrew Imparato, President and CEO, American Association of People with Disabilities |
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Mark B. Leahey, Esq., Executive Director, MDMA |
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Moderator: |
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Sarah Walter, Walter Consulting, Inc. |
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12:30-1:45 pm |
MDMA Luncheon
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1:45-2:45 pm |
Market Access: Reforming GPO Practices, Improving Quality, and Reducing Cost
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Speakers: |
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Mark B. Leahey, Esq., Executive Director, MDMA |
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Seth Bloom, Minority Senior Counsel, Senate Judiciary Antitrust Subcommittee |
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Hal J. Singer, PhD, President, Criterion Economics L.L.C. |
2:45-3:00 pm |
Preparing To Hit the Hill
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3:30-5:30 pm |
Congressional Fly-in
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Conference participants attend Hill meetings with their respective Senators and Representative to discuss issues affecting the innovative medical technology industry.
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5:00-7:00 pm |
MDMA Chairman's Reception Honoring U.S. Senator Michael B. EnziI (R-WY), Chairman of the Senate Committee on Health, Education, Labor, & Pensions
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MDMA will present U.S. Senator Michael Enzi (R-WY), Chairman of the Senate Heath, Education, Labor, and Pensions Committee, with the 2006 MDMA Chairman’s Award at a reception in the Dirksen Senate Building, room SD-430. MDMA is honoring Chairman Enzi for his long-time support of innovative entrepreneurial medical technology companies. |
THURSDAY 6.15.06 |
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8:00-8:30 am |
Continental Breakfast
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8:30-9:00 am |
R&D Commercial Strategy and the Role of Innovation
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Jacques Mulder, Principal, Life Sciences, Strategy & Operations, Deloitte Consulting, LLP |
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9:00-10:00 am |
What Lies Ahead? Critical Post Market Issues Facing Medical Technology Companies
This session will explore various regulations concerning manufacturer interactions with healthcare professionals as well as FDA and CMS post market issues.
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W. Andrew H. Gantt III, Partner, Latham & Watkins LLP |
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James Ravitz, Esq., Arent Fox PLLC |
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10:00-10:15 am |
Break |
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10:15-11:30 am |
Effects of Recent Patent Law Developments
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Les Bookoff, Partner, Finnegan Henderson Farabow Garrett & Dunner L.L.P
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Barbara McCurdy, Partner, Finnegan Henderson Farabow Garrett & Dunner L.L.P |
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Steve Jensen, Partner, Knobbe Martens Olson & Bear LLP |
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11:30-12:30 pm |
Medicare Payment Issues
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Panelists: |
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Tom Gustafson, Deputy Director, Center for Medicare Management, CMS |
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Jo Ellen Slurzberg, Vice President, Reimbursement & Health Policy, Almyra Inc. |
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Moderator: |
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Beth Roberts, Partner, Hogan & Hartson L.L.P. |
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12:30-1:45 pm |
Luncheon Keynote: CMS Administrator's Update
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Mark B. McClellan, MD, PhD, Administrator, CMS |
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1:45-2:00 pm |
Closing Remarks
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Mark B. Leahey, Esq., Executive Director, MDMA |
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SPONSORS
Please click on the logos below to learn more about our sponsors. |
PRESENTING SPONSOR |
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SILVER SPONSORS
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BRONZE SPONSORS
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