04-12476. Office of the Secretary of Defense (Health Affairs)/TRICARE Management Activity

AGENCY:

Department of Defense.

ACTION:

Notice of extension of the Myelomeningocele Clinical Trial Demonstration Project.

SUMMARY:

This notice is to advise interested parties that the National Institute of Child Health and Human Development (NICHD) demonstration project in which Department of Defense (DoD) is participating will continue. The purpose of this study is to determine whether it is better to close a spina bifida defect before the baby is born or shortly after birth. The demonstration previously scheduled to end April 1, 2004, is now extended until the enrollment reaches 200 nationwide. This demonstration project is being conducted under the authority of 10 U.S.C. 1092.

EFFECTIVE DATE:

April 1, 2004.

FOR FURTHER INFORMATION CONTACT:

Gail L. Jones, Health Care Policy Analyst, Medical Benefits and Reimbursement Systems, TRICARE Management Activity (TMA), 16401 East Centretech Parkway, Aurora, CO 80011-9066, telephone [phone].

SUPPLEMENTARY INFORMATION:

DoD provided a notice in the Federal Register (68 FR 7351-7352) published on Thursday, February 13, 2003, which set forth basic procedures for participation in the myelomeningocele demonstration project sponsored by the NICHD, wherein DoD provides TRICARE reimbursement for all eligible DoD beneficiaries, including active duty service members, to receive prenatal and postnatal surgical intervention for the repair of myelomeningocele.

The NICHD expects a total of two hundred patients (nationwide) whose fetuses have been diagnosed with myelomeningocele at 16 to 25 weeks' gestation and who are over the age of 18 years would be enrolled and referred to the Data and Study Coordinating Center (DSCC) at George Washington University in Rockville, Maryland, to undergo an initial evaluation. Those individuals who remain eligible and interested would be assigned by the DSCC to one of the three centers (Vanderbilt University Medical Center in Nashville, the University of California at San Francisco, or Children's Hospital of Philadelphia) where final evaluation and screening will be performed.

DoD continues to expect six to sixteen TRICARE members each year would have a fetus with a prenatal diagnosis of spina bifida and would be eligible for the NICHD clinical trial and agree to participate.

Participation in this clinical trial will improve access to prenatal and postnatal surgical intervention for the repair of myelomeningocele for active duty members, former members, and their dependents when their condition meets protocol eligibility criteria.

Dated: May 26, 2004.

L.M. Bynum,

Alternate OSD Federal Register, Liaison Officer, Department of Defense.