With over one million knee and hip replacements being performed every year in the United States and no system in place to track their success, U.S. Rep. Bill Pascrell, Jr. (D-NJ-08) and U.S. Rep. Lloyd Doggett (D-TX-25), both members of the House Ways and Means Health Subcommittee, today introduced legislation to create a knee and hip replacement registry.

“The Knee and Hip Replacement Act would help ensure that only the best and most effective medical devices are made available to American patients,” stated Pascrell.  “It would reduce the number of costly and complicated do-over surgeries and save taxpayers billions of dollars.  It is outrageous that medical devices are being made available in America that are so lousy they have been withdrawn in markets overseas.  As Congress seeks to reform healthcare and reduce Medicare costs, bringing higher standards to the medical device industry would be a good place to start.”

“The simple, practical step of registering knee and hip replacement devices ensures not only that patients get the high quality care they deserve, but also that financial gain never stands in the way of healthy outcomes and patient safety,” said Congressman Doggett, an original co-sponsor of the legislation.  “By registering these devices, we can detect problems much sooner than we previously were able.  This in turn will give patients the peace of mind to know that their knee or hip replacement procedure will not become part of the estimated $700 billion Americans spend every year on procedures that don’t result in better health outcomes.” 

The Knee and Hip Replacement Act of 2009 would establish a national registry to collect and analyze data on patients with hip and knee replacements.  The registry would be established within the Agency for Healthcare Research and Quality (AHRQ) at the Department of Health and Human Services (HHS) and require the collection of data begin no later than five years after enactment. 

AHRQ would work in consultation with the Center for Medicare and Medicaid Services (CMS) the Food and Drug Administration (FDA), the National Institutes of Health (NIH) and the Office of the National Coordinator for Health IT (ONCHIT) to develop policies and procedures for the Registry.  In order for Congress to adequately oversee the Registry’s progress, the Government Accountability Office (GAO) would be required to submit a report on the Registry to Congress every other year.

With as many as 18% of hip and knee replacements requiring costly revision surgeries to repair or replace failed devices, Pascrell addressed burdensome Medicare costs and touted the legislation’s ability to act as a cost saving alternative.  

“Creating a knee and hip registry is a common sense way to reduce wasteful Medicare spending,” stated Pascrell.  “With half of all knee and hip replacements occurring right here in the United States where billions of dollars are lost every year on faulty medical procedures and treatments, it is time that the medical device industry be held accountable for the expensive products they implant in patients.  Creating a registry would put a premium on performance and help patients make an educated decision before they enter into a major medical procedure.”     

Since Pascrell began drafting the Knee and Hip Replacement Act in the summer of 2008, leaders in the orthopedic surgery industry have made strides towards creating a registry. 

Noting the orthopedic surgeons’ intentions, Pascrell stated, “I am pleased that the orthopedic surgeons recognize a need to monitor the products they use to do their work, but am doubtful they will be able to collect the level of data called for in my legislation.  Registering knee and hip replacements will give surgeons the tools they need to make evidence-based decisions on the products they purchase and procedures they employ.”

“If America is to be a leader in the medical technology field, it is critical that we take a hard, honest look at how patients are faring and identify any issues that may affect future patients.  The baby boomers aren’t getting any younger and there is no doubt that the number of orthopedic surgeries will only climb in the coming years.  The time to act is now and I am fighting to include a knee and hip registry in any healthcare reform initiative,” concluded Pascrell.

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