PRESS RELEASE
from the Texas Back Institute

Texas Back Institute’s GRASSROOTS CAMPAIGN HELPS BRING ATTENTION TO ARTIFICIAL DISC COVERAGE  

PLANO, TEXAS – June 14, 2006 – In a grassroots attempt to notify their patients of the Center for Medicare and Medicaid Services’ (CMS) decision to not cover patients who are in need of an artificial disc, the surgeons and physicians of Texas Back Institute provided their patients with form letters to submit during the CMS public response period, protesting their decision.  An overwhelming 492 people responded to Texas Back Institute’s call to action by sending the form letters back to CMS in favor of coverage of the CHARITE Artificial Disc, with many others showing their support by filling out the online response form. 

According to industry consultants, it is important for those concerned with CMS recommendations to answer the call during the response period, as the outside insurance sector often follows their recommendations for their decision making process.

"Non-Medicare payers tend to follow CMS decisions," said industry consultant Barb Peterson in an article for HealthPoint Capital, an organization that focuses exclusively on the orthopedics sector. "So, if CMS does issue a non-coverage decision, device companies will have an uphill battle to get all payers to cover and pay for artificial discs. Overturning a national non-coverage decision requires an enormous effort, published data and years to succeed."

The Center for Spine Arthroplasty at Texas Back Institute had three physicians serving as investigators during the U.S. Food and Drug Administration (FDA) trial phases for Johnson and Johnson’s CHARITE Artificial Disc. Scott L. Blumenthal, M.D., Richard D. Guyer, M.D. and Stephen H. Hochschuler, M.D. of TBI were chief investigators in the trial and they along with their partners are currently working on the FDA trials for several other artificial discs.  The center’s work during the trials helped show that artificial disc replacement, and the CHARITE disc specifically, helps maintain flexibility, improves pain and function and allows patients to leave the hospital sooner than those undergoing traditional fusion surgeries.

“Artificial disc replacement is an improvement in care for our patients, but as with any surgical procedure, patients must be chosen correctly,” said Guyer, who also serves as president of Texas Back Institute.  “We are very gratified that our past CHARITE patients and their families who have benefited from the procedure participated in the letter campaign.  Many more people will be able to benefit from the procedure now, since CMS has reversed their decision.”

CMS’s May 16, 2006 decision to reverse its proposed non-coverage determination for CHARITE will allow access to the patients who need the procedure and can benefit from the technology.  TBI hopes that their attention to the matter and movement to get letters in to reverse the decision will help increase the level of care for patients for many years to come.

In keeping with their commitment of service to patients, TBI was one of the first spine clinics in the country to receive delivery of the second generation CHARITE Artificial Discs.  These discs help maintain stability and offer a wider range of sizing options for the patient.  This new arrival is in addition to the other discs currently being studied at TBI for FDA approval.  The new decision from CMS sets the stage to allow coverage for correctly selected Medicare and Medicaid patients will only help serve more patients as the new artificial discs come to market.

“Currently, the surgeons with TBI have the best chance possible for getting patient’s insurance approved for an artificial disc through the many studies and cases we are involved in,” said Guyer.  “If self pay is the only option for an artificial disc, TBI’s price is competitive with those of Europe, while also offering the satisfaction of local doctor follow-up and ongoing FDA sponsored research.”

Texas Back Institute

Texas Back Institute (TBI) is one of the largest freestanding spine specialty clinics in the United States. The Institute, based in Plano, Texas, was established in 1978 and provides comprehensive medical care for individuals with back and neck pain. TBI is a back care leader specializing in spinal arthroplasty minimally invasive spine surgery, spinal deformation and spinal oncology care. As an academic health care organization, TBI has trained hundreds of physicians, scientists and allied health professionals. Its research institution employs state-of-the-art technology and research to treat patients and is involved in the most clinical trials of artificial discs. TBI’s professional staff includes board-certified spine surgeons, general surgeons, internists, chiropractors, physiatrists, pain specialists, exercise physiologists and a team of physical and occupational therapists. Texas Back Institute’s main office is located in Plano, with offices in Denton, Fort Worth, Greenville, Garland,  Midland, Trophy Club, TX and Phoenix, AZ. For more information, visit www.texasback.com.

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For more information, contact Meredith Falke, (214) 891-7795 meredith_falke@richards.com

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