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AdvaMed Supports Key Changes to Disclosure Legislation
Date:2/26/2008

Key Changes Recommended to S. 2029 to Ensure Information is Meaningful and in Appropriate Context

WASHINGTON, Feb. 26 /PRNewswire-USNewswire/ -- The Advanced Medical Technology Association (AdvaMed) today expressed support for the appropriate disclosure of financial relationships with physicians by putting forth key changes to proposed legislation that would help ensure patients receive useful, meaningful information that puts such payments in full context.

"Continued innovation in medical technology relies on direct interaction with physicians who have first-hand clinical experience with advanced medical treatments in their practice of patient care. Our industry works closely with physicians to invent new medical devices, improve existing technologies and provide training to physicians to ensure they can use devices safely and effectively," said Stephen J. Ubl, president and CEO of AdvaMed.

"The importance of the relationship between physicians and medical technology innovators cannot be understated -- it is a critical component of the engine that drives the next wave of medical advancements. In an effort to underscore the importance of physician/medical innovator collaboration, and to ensure openness with those relationships, AdvaMed would support S. 2029 (the Physician Payment Sunshine Act), provided that key changes are made to the bill," said Ubl.

"Our goal in putting forth these important changes is to ensure that disclosure of industry relationships with physicians is fair and meaningful, that the compliance burdens imposed on our member companies are reasonable, and that the legislation allows clinicians and technology innovators to continue to improve patient care," said Ubl.

AdvaMed believes that S. 2029 could be improved significantly by:

-- Expressly preempting state disclosure laws to ensure consistency in application and patient understanding;

-- Applying the requirements to all companies that make a significant amount of aggregate payments to physicians, while excluding those that do not;

-- Requiring compliance by physician-owned manufacturers, distributors and group purchasing organizations (GPOs); and

-- Displaying disclosure information in a meaningful and easily-understood format that provides the appropriate context for patient education.

AdvaMed also recommends other changes to assure that the program is workable and provides meaningful information. Examples include:

-- Protecting manufacturer's proprietary information for technologies under development by ensuring that disclosure of consulting arrangements for clinical trials and product development agreements are required only after a product is approved or cleared by the FDA;

-- Exempting reporting of medical textbooks, anatomical models, or items having a fair market value of less than $100 that benefit patients, relate to physicians' work, or serve an educational function; and

-- Exempting certain items, such as demonstration units and models for physician and patient evaluation.

"The medical technology community is committed to preserving patients' faith and trust in our products and devices. We look forward to working with Senators Grassley and Kohl and other Members of Congress on this important matter," said Ubl.

AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming healthcare through earlier disease detection, less invasive procedures and more effective treatments. Our members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent purchased annually around the world. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit http://www.advamed.org.


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