Healthcare Industry News:  lumbar spinal stenosis 

Devices Reimbursement Neurosurgery Orthopaedic

 News Release - November 7, 2006

CMS Approves Pass-Through Payment for the X STOP Procedure, Allowing Coverage for Patients Who Are Treated in a Hospital Outpatient Setting

SAN FRANCISCO--(HSMN NewsFeed)--St. Francis Medical Technologies, Inc.® announced today that the Centers for Medicare and Medicaid Services (CMS) approved a pass-through payment that will provide additional device payments when the X STOP® Interspinous Process Decompression (IPD®) System ("X STOP") is implanted in a hospital outpatient setting.

"CMS' decision to approve the X STOP pass-through application provides Medicare and Medicaid beneficiaries improved access to the X STOP device without the need for a hospital stay," said Kevin Sidow, president and chief executive officer of St. Francis Medical Technologies.

Effective January 1, 2007, the new device pass-through code, C1821, will include device costs for single- and double-level treatments, and is applicable nationally. Non-device related costs will be reimbursed under newly assigned APC 0050, valued at $1,455.67 per treated level.

The supplemental payments are intended to provide additional funding for new technologies that meet a cost threshold and demonstrate a substantial clinical improvement over existing treatment options.

lumbar spinal stenosis is a common spinal problem involving a narrowing or constriction of the spinal canal, which causes impingement on the spinal cord and nerve roots that extend to the legs. The impinged nerves commonly cause pain, weakness and numbness in the lower back, buttocks and legs. Industry sources estimate that there are currently approximately 1.4 million individuals in the United States with a primary or secondary diagnosis of lumbar spinal stenosis.

About the X STOP:

The X STOP® Interspinous Process Decompression (IPD®) System ("X STOP") is a less invasive implant designed to treat lumbar spinal stenosis. Inserted through a small incision, the X STOP is placed between two bones called spinous processes in the low back. The X STOP is designed to limit extension of the lumbar spine and keep open the canal in the lower spine that carries nerves to the legs, thereby relieving symptoms.

The device is surgically implanted in a minimally invasive procedure that can be typically performed with local anesthesia in less than an hour. As it is not fixed to any bony structures, the X STOP procedure does not result in fusion and is completely reversible without compromising any therapeutic alternatives, including laminectomy.

The X STOP was approved by the FDA for U.S. commercial sales in November 2005 and has been commercially available in Europe since 2002. Since introduction of the X STOP, more than 11,000 X STOP devices have been sold worldwide.

About St. Francis Medical Technologies:

St. Francis Medical Technologies is a privately held medical device company based in Alameda, California focused on the design, development and marketing of motion-preserving technologies and procedures for orthopedic and neurological spine surgery. The X STOP is the company's initial product. For more information, please visit:

Source: St. Francis Medical Technologies

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