[Federal Register Volume 68, Number 30 (Thursday, February 13, 2003)]
[Notices]
[Pages 7351-7352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-3512]


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DEPARTMENT OF DEFENSE

Office of the Secretary


TRICARE: In-Utero Surgical Repair of Myelomeningocele Randomized 
Clinical Trial

AGENCY: Office of the Secretary, DoD.

ACTION: Notice.

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SUMMARY: This notice is to advise interested parties of a demonstration 
project in which the Department of Defense (DoD) will participate in a 
clinical trial for prenatal and postnatal myelomeningocele repair 
approved by the National Institute of Child Health and Human 
Development (NICHD). The study is being done to find out whether it is 
better to close a spina bifida defect before the baby is born or 
shortly after birth. 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. 
DoD financing of this procedure will assist in meeting clinical trial 
goals and arrival at conclusions regarding the safety and efficacy of 
intrauterine repair of fetal myelomeningocele. It is anticipated that 
new enrollments into the clinical trial will end in April 2004, with 
those enrolled having periodic examinations during a three-year follow-
up period. This demonstration project is being conducted under the 
authority of 10 U.S.C. 1092.

EFFECTIVE DATES: March 17, 2003.

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:

A. Background

    Myelomeningocele is the most severe form of spina bifida. In a 
fetus with myelomeningocele, there is evidence that neurologic function 
deteriorates during gestation. While myelomeningocele is not 
necessarily life threatening, it is the most common debilitating birth 
defect. Those who survive are likely to experience significant life-
long disabilities. Approximately 2,000 fetuses annually are affected 
with some kind of open neural tube defect in the United States, half of 
which are open spina bifida. The surgical repair of myelomeningocele in 
utero is the technique that may provide early intervention in 
preserving the neurologic integrity of these children. To date, 
clinical results of fetal surgery for myelomeningocele are based on 
comparisons with past controls and addresses efficacy rather than 
safety. A randomized clinical trial for myelomeningocele is necessary 
to determine whether fetal repair of myelomeningocele, with its 
attendant maternal and neonatal morbidity, is warranted.
    The Department of Defense (DoD) provides and maintains readiness to 
provide medical services and support to the Armed Forces during 
military operations, and to provide health services and support to 
members of the uniformed forces, their family members, and to others 
entitled to DoD medical care. The services offered to TRICARE 
beneficiaries other than active duty members must be medically 
necessary, appropriate, and proven care and are governed by 10 U.S.C. 
1079(a)(13).

[[Page 7352]]

    Active duty service members are authorized civilian medical care 
under 10 U.S.C. 1074(c), and may be referred for unproven therapy when 
controlled in a formal clinical research trial. The trial must be 
operating under the structure of an institutional review board process, 
which conforms to the requirements of DoD Directive 3216.2, Protection 
of Human Subjects and Adherence of Ethical Standards in DoD Supported 
Research, the requirements of 32 CFR part 219, Protection of Human 
Subjects, as well as Service specific human experimentation 
regulations.
    DoD has the authority to waive the statutory limitation for all 
other DoD beneficiaries that health care services must be medically 
necessary, appropriate, and proven care, as long as these services are 
provided within the context of an interagency agreement with the 
National Institutes of Health (NIH) for beneficiary participation in 
NIH-sponsored or approved clinical trials. The Secretary of Defense 
must also determine that such waiver will promote access by covered 
beneficiaries to promising new treatments and contribute to the 
development of such treatments.

B. Caseload, Costs

    Each year approximately 60,000 TRICARE births occur at the Military 
Treatment Facilities (MTFs). Approximately 40,000 TRICARE births occur 
in civilian hospitals. According to the Center of Disease Control, in 
2001 there were 20.09 cases of spina bifida per 100,000 births. Based 
on various studies, we estimate that 95 percent of these reported cases 
are related to myelomeningocele. We then interpret that approximately 
19 cases would occur annually in TRICARE. We expect six to sixteen 
TRICARE members each year would have a fetus with a prenatal diagnosis 
of spina bifida that would be eligible for the NICHD clinical trial and 
would agree to participate.
    Treatment protocol costs are estimated between $300,000 and $1.3 
million over Fiscal Years 2003 through 2006 for TRICARE participation 
in the NICHD clinical trial of myelomeningocele fetal repair.

C. Operation of the Demonstration

    The National Institute of Child Health and Human Development 
(NICHD) will fund an unblinded randomized controlled clinical trial 
conducted by three participating centers. The NICHD will provide 
administrative support, all NICHD enrollments, and study monitoring 
activities. DoD will provide a Project Officer who will coordinate DoD 
activities.
    The DoD will develop initiatives to educate military healthcare 
providers and civilian TRICARE network providers about this initiative 
and the processes that are available for referral and pre-authorization 
of individuals with affected fetuses. DoD will require pre-
authorization for any clinical services necessary or resultant from 
participation in an NICHD sponsored clinical trail before reimbursement 
by TRICARE. A pre-authorization for enrollment in the trial will 
suffice to cover each incidental expense or claim related to 
participation in the clinical trial extending through the duration of 
the clinical trial. The pre-authorization process will include 
verification with the NICHD that the patient has been enrolled in the 
study.
    The TRICARE contractor(s) would not be involved in clinical issues 
or in directing patients to a particular institution.

D. Requirements for Participation

    Active duty members, former members, and their dependents eligible 
for TRICARE who meet the clinical trial protocol would be eligible to 
participate in the demonstration. NICHD anticipates a total of two 
hundred patients whose fetuses have been diagnosed with 
myelomeningocele at 16 to 25 weeks' gestation 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, and 
Children's Hospital of Philadelphia) where final evaluation and 
screening will be performed. Patient selection to the three Management 
of Myelomeningocele Study (MOMS) Centers would be based on convenience 
to the individual as well as the need to divide evenly the participants 
among the three centers.

E. Costs

    Patients who choose to participate in the clinical trial will have 
no additional costs for prenatal care beyond what is normally paid by 
the beneficiary. If TRICARE beneficiaries have other health insurance, 
the other health insurance is required to pay first before TRICARE to 
the extent the health care is a benefit under the other plan as stated 
under 10 U.S.C. 1079(j)(1). If patients are in a prenatal surgery 
group, the travel, meal and lodging costs for the patient and a 
relative or friend will be covered by NICHD grant support or the 
grantee institution until delivery and after delivery, until the 
patient and baby go home.
    If patients are in a postnatal surgery group, travel back to the 
center for the patient and a support person will be covered by NICHD 
grant support or the grantee institution, as well as meals and lodging 
before and after delivery, until the baby and patient are able to go 
home. The cost of the study follow up, returning at one year and two 
and a half years of age will also be covered. Meals and lodging will be 
covered for those visits as well.

    Dated: February 5, 2003.
Patricia L. Toppings,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 03-3512 Filed 2-12-03; 8:45 am]
BILLING CODE 5001-08-M