Intent is positive, but proposal has drawbacks

A bill to create a government-run joint registry program has been introduced in the U.S. House of Representatives. The “National Knee and Hip Replacement Registry Act of 2009,” sponsored by Reps. William Pascrell Jr. (D-N.J.) and Lloyd Doggett (D-Texas), would establish the registry within the Agency for Healthcare Research and Quality.

According to the legislation, the joint registry would collect, store, and analyze data to achieve the following goals:

• identify predictors that may lead to poor outcomes in knee and hip replacement surgeries to assist health care providers in medical and surgical decision-making
• improve patient care and outcomes generally
• detect poorly performing prostheses and surgical techniques
• reduce the number of knee and hip replacement revision surgeries required nationwide

Data for the registry would be collected through “existing federal reporting requirements” and voluntary submission of Medicare and non-Medicare patient data by practitioners and providers.

“The AAOS strongly supports the intent of this legislation. We could fully support it if it established an independent joint registry with the same legal protections for orthopaedic surgeons that it has proposed for patients and implant manufacturers,” he continued.

“As we understand the bill, it calls for a government-run entity,” Dr. Berry said. “As such, it would analyze only the information pertaining to patients who have had surgeries paid for by the government. This would provide a great deal of data but would exclude a huge number of the patients who have joint replacements every year.”

Approximately 60 percent of all joint replacements are now paid for by Medicare or a government entity. That percentage is expected to decline, however, as the number joint replacements for younger patients—those in their 40s and 50s who do not participate in Medicare—increases.

According to Dr. Berry, these younger patients are also at highest risk for failure of their implants, over the lifetime of the device, because they are more active—putting greater stress on their implants. “Not including that group of patients is a real drawback of a government-run registry,” he noted.

The participation challenge
Crucial to the success of a registry is the ability to capture data on 90 percent or more of all joint replacements.

This requires a high level of participation from a number of stakeholders—hospitals, patient advocates, payors, industry, government agencies, and orthopaedic surgeons.

“To increase the probability that all the stakeholders will participate, each one needs to have a seat at the table,” said Dr. Berry.

“When all of the stakeholders actively participate in the registry, the credibility of registry will increase among those participants. If the stakeholders find the data credible, they are more likely to use the data to improve the care of patients,” he explained.

Joint registries are also most effective when they function over decades—not parts of a decade, according to Dr. Berry. “To understand the subtleties of how implants are working, it’s important that a registry follow patients for their lifetimes, not just for a very short period of time.”

The legislation proposes funding for the government joint registry for 9 years.

AJRR is within striking distance
“The AAOS believes that a national joint registry will be most effective as an independent, not-for-profit organization that includes all patients,” said Dr. Berry. “We believe a successful joint registry should have a long-term strategy that includes privacy, monitoring, and funding guidelines.

“This year, AAOS has made great strides in bringing the American Joint Replacement Registry (AJRR) to reality.”

The AJRR will be an independent registry developed, implemented, and operated by various stakeholders, including orthopaedic surgeons with expertise in joint replacement, patient advocates, implant manufacturers, hospitals, and government agencies.

It is designed to have an estimated 90 percent capture rate and will include younger patients, which will provide more comprehensive orthopaedic data and an early warning system for various problems.

Earlier this year, the AAOS authorized $300,000 in start-up funding for AJRR. This is in addition to the nearly $500,000 that the Academy has allocated to this project over the last 5 years. The Hip Society, The Knee Society, and the American Association of Hip and Knee Surgeons have each recently contributed $50,000 in start-up funding.

The registry project team has engaged consultants to assist in this endeavor. They are currently working with interested stakeholders to devise a long-term source of funding for the AJRR as well as developing a data network for the registry.

“We have also formed project work groups to tackle data, governance, and oversight issues. We have defined the core data sets for the registry and will be talking to the device manufacturers and to some of the other user groups to capture their data question requirements,” Dr. Berry explained.

The AJRR has been incorporated in Illinois as a not-for-profit corporation. It is sited in Illinois in part because the scope of privilege under the Illinois Medical Studies Act will help protect collected information. The AJRR is now seeking 501(c)(3) status from the Internal Revenue Service.

Based on the progress that has been made to date, data collection for AJRR could begin in 18 to 24 months.

“We are very passionate about this effort and care deeply that this is implemented in a manner that benefits patients and orthopaedic science,” Dr. Berry concluded.

Dr. Berry reports the following disclosures: DePuy, A Johnson & Johnson Company; Wolters Kluwer Health - Lippincott Williams & Wilkins; Stryker; and Zimmer.

Annie Hayashi is the senior science writer for AAOS Now. She can be reached at hayashi@aaos.org.

For more information on the AAOS American Joint Registry Replacement Project, visit www.aaos.org/registry

Provisions of HR 2813
Under the “National Knee and Hip Replacement Registry Act of 2009,” the joint registry is to be established not later than 3 years after the enactment of the bill.

• Data collection would commence no more than 5 years after passage of the legislation.
• Feedback from the public would be sought 2 years after data collection efforts had begun and public reports would be available 6 years after the bill had been approved.
• Health care providers would receive data 6 years after the legislation had passed and device manufacturers would get data after 7 years to “evaluate the safety and performance of their products relative to similar products available on the market.”

All groups would receive reports on an annual basis after the initial release of the data.

The legislation seeks financial appropriations for the period from 2010 to 2019. The joint registry is estimated to cost between $18 million and $20 million a year.