[Federal Register Volume 69, Number 107 (Thursday, June 3, 2004)]
[Notices]
[Pages 31369-31370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-12476]


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DEPARTMENT OF DEFENSE

Office of the Secretary


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.

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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 (303) 676-3401.

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.


[[Page 31370]]


    Dated: May 26, 2004.
L.M. Bynum,
Alternate OSD Federal Register, Liaison Officer, Department of Defense.
[FR Doc. 04-12476 Filed 6-2-04; 8:45 am]
BILLING CODE 5001-06-M