[Federal Register: February 13, 2003 (Volume 68, Number 30)]
[Notices]
[Page 7351-7352]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13fe03-22]
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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