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/ 2002
/ June
/ Tuesday, June 25, 2002
[Federal Register: June 25, 2002 (Volume 67, Number 122)]
[Rules and Regulations]
[Page 42717-42722]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jn02-7]
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DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 199
RIN 0720-AA28
TRICARE; Revisions to Coverage Criteria for Transplants, Cardiac
and Pulmonary Rehabilitation and Ambulance Services
AGENCY: Office of the Secretary, DoD.
ACTION: Final rule.
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SUMMARY: This final rule implements a number of regulatory revisions
relating to TRICARE coverage for transplants and related services,
cardiac and pulmonary rehabilitation and ambulance services. The
revisions are clarification of TRICARE coverage and time limitations on
preauthorizations for solid organ and stem cell transplantation for
beneficiaries whose conditions are considered appropriate
[[Page 42718]]
for transplantation according to guidelines adopted by the Executive
Director, Tricare Management Activity (TMA), or a designee;
clarification of TRICARE coverage for ambulance service for organ and
stem cell transplant candidates; recognition of certain transplant
centers as authorized TRICARE institutional providers according to
provisions adopted by the Executive Director, TMA, or a designee;
clarification of pediatric consortium programs for organ
transplantation according to provisions adopted by the Executive
Director, TMA, or a designee; extension of coverage for cardiac
rehabilitation for those patients who have had heart valve surgery,
heart or heart-lung transplantation; establishment of coverage for
pulmonary rehabilitation for beneficiaries whose conditions are
considered appropriate for pulmonary rehabilitation according to
guidelines adopted by the Executive Director, TMA, or a designee; and
elimination of payment restrictions for MTF ordered ambulance
transfers.
DATES: This final rule is effective July 25, 2002, except 199.4
(e)(18)(i)(F) and (e)(18)(i)(G) are effective December 1, 1991.
ADDRESSES: TRICARE Management Activity (TMA), Medical Benefits and
Reimbursement Systems, 16401 East Centretech Parkway, Aurora, CO 80011-
9066.
FOR FURTHER INFORMATION CONTACT: Marty Maxey, Medical Benefits and
Reimbursement Systems, telephone (303) 676-3627.
SUPPLEMENTARY INFORMATION:
I. Introduction and Background
In the Federal Register of March 17, 1995 (60 FR 14403), the Office
of the Secretary of Defense published for public comment a proposed
rule regarding a number of changes relating to organ transplants. We
received comments from government agencies that by law CHAMPUS is
required to consult with during the rule making process. Following is a
summary of the changes included in the proposed rule, an analysis of
the comments received and provisions of the final rule.
II. Provisions of the Rule
A. Proposed Changes to Organ Transplantation
1. Coverage for Heart-Lung, Single or Double Lung, and Combined Liver-
Kidney Transplantation
Provisions of the Proposed Rule. The proposed rule established
coverage for heart-lung, single or double lung and combined liver-
kidney transplantation. Section 199.4, paragraph (e)(5) of 32 CFR
allows Basic Program benefits to be extended for otherwise covered
services or supplies in connection with an organ transplant procedure,
provided such transplant procedure generally is in accordance with
accepted professional medical standards and is not considered to be
experimental or investigational. Based on recommendations from the
National Heart Lung and Blood Institute (NHLBI) on heart-lung, single
and double lung transplantation and technology assessments from the
Agency for Health Care Policy and Research (AHCPR) on heart-lung,
single and double lung transplantation and combined liver-kidney
transplantation, TRICARE determined it could no longer deny coverage
for these transplant procedures as investigational since safety,
efficacy and superiority to conventional treatments had been
established.
Analysis of Major Public Comments. Several commentors brought to
our attention that we incorrectly stated HCFA, renamed the Centers for
Medicare and Medicaid Services (CMS), requested the Agency for Health
Care Policy and Research (AHCPR) to perform assessments on lung and
heart-lung transplantation when it was the Office of Civilian Health
and Medical Program of the Uniformed Services (OCHAMPUS), renamed
TRICARE Management Activity, who initiated the requests.
Response: It is hereby noted the commentor's statements are
correct.
In the preamble of the proposed rule, we stated the findings of the
AHCPR assessment indicated that combined liver-kidney transplantation
is an effective intervention in improving survival in patients with
end-stage renal and hepatic disease. A commentor from AHCPR indicated
the language should be changed to read: ``The findings of the AHCPR
assessment indicated that the combined liver-kidney transplantation may
be an effective intervention in improving survival in patients with
end-stage renal and hepatic disease, but also discussed that factors
related to patient selection and institutional criteria must be
considered.''
Response: Although the preamble language of the proposed rule is
not included in the final rule, we concur with the comment and note it
accordingly.
One commentor felt the proposed rule language regarding liver
transplantation coverage for primary liver tumors should be more
explicit.
Response: As stated below in the Provisions of the Final Rule, all
covered transplant procedures and the patient selection criteria has
more appropriately been placed in the TRICARE/CHAMPUS Policy Manual.
The information in the TRICARE/CHAMPUS Policy Manual is more explicit
than that contained in 32 CFR part 199. The TRICARE/CHAMPUS Policy
Manual can be accessed through TRICARE's Web site at
www.tricare.osd.mil.
A commentor suggested we ask CMS, formerly HCFA, to describe its
method of calculating and charging acquisition costs for kidneys
because the proposed rule incorrectly states that all kidney recipients
pay the ``same standard'' costs.
Response: We contacted CMS, formerly HCFA, and were advised the
information regarding kidney acquisition costs is correct. The proposed
regulatory language did state standard acquisition costs for live
donors is different than that of cadavers.
A commentor believed the transportation cost of a living donor
should be considered a TRICARE benefit.
Response: Transportation except by ambulance is specifically
excluded under paragraph 199.4(g)(67).
One commentor questioned whether the effective date of July 1,
1983, for liver transplantation is correct.
Response: The July 1, 1983, date is correct.
Another commentor asked whether denying coverage for liver
transplantation for those patients with ``active alcohol and other
substance abuse'' preclude paying for a liver transplantation for
someone with alcoholic cirrhosis? The same question was applied to
combined liver-kidney transplantation.
Response: Coverage may be allowed if the patient has documented
abstinence prior to transplantation and there is no evidence of other
major organ debility. In addition, there must be evidence of ongoing
participation in a social support group such as Alcoholics Anonymous;
and evidence of a supportive family/social environment. These criteria
are detailed in the TRICARE/CHAMPUS Policy Manual and can be accessed
through TRICARE's Web site at www.tricare.osd.mil.
Several commentors suggested changing the phrase ``medically
necessary and generally accepted practice . . .'' to terms such as
``medically necessary because it represents generally accepted practice
. . .'' or ``reasonable and necessary.'' It was also suggested the term
``non-investigational,'' was confusing and should not be used.
[[Page 42719]]
Response: The phrase ``medically necessary and generally accepted
practice . . .'' has been changed to read ``. . . medically necessary
for the treatment of the condition for which it is administered,
according to accepted standards of medical practice.'' The term ``non-
investigational'' has been removed.
Provisions of the Final Rule. When the CHAMPUS final rules on Liver
and Heart Transplants were published in 1986, the science of solid
organ transplants was relatively new, therefore, detailed guidelines
for these transplants were published in paragraph 199.4 (e)(5). The
purpose of the Code of Federal Regulations is to provide broad
guidelines and policies; the publishing of detailed guidelines in
paragraphs 199.4 (e)(5)(v) and (e)(5)(vi) for liver and heart
transplants has proved difficult to maintain. For example, one of the
contraindications listed in paragraph 199.4 (e)(5)(v)(B) for liver
transplants is viral-induced liver disease when viremia is still
present. Recent studies show liver transplants for patients with end-
stage liver failure resulting from hepatitis B and C is safe, effective
and comparable to standard treatment.
Many transplant procedures are no longer considered unproven and
are covered under TRICARE. To assist our beneficiaries in obtaining
coverage for new transplant procedures in a timely manner, detailed
policy and patient selection criteria for each covered transplant has
more appropriately been placed in the TRICARE/CHAMPUS Policy Manual.
The TRICARE/CHAMPUS Policy Manual contains operational policy necessary
to efficiently implement 32 CFR part 199. The TRICARE/CHAMPUS Policy
Manual augments 32 CFR part 199 and must be used in conjunction with
the CFR for complete policy information. The TRICARE/CHAMPUS Policy
Manual can be accessed through TRICARE's Web site at
www.tricare.osd.mil.
Paragraph (e)(5) continues to allow Basic Program benefits to be
extended for otherwise covered services or supplies in connection with
an organ or stem cell transplant procedure, provided such transplant
procedure generally is in accordance with accepted professional medical
standards and is not considered unproven.
Since publication of the proposed rule, a final rule clarifying the
exclusion of unproven drugs, devices and medical treatments and
procedures was published in the Federal Register on January 6, 1997 (62
FR 625). The final rule adopted the use of the term ``unproven''
instead of investigational or experimental, therefore, we have replaced
the terms investigational and experimental with the term unproven.
2. Time Limit on Preauthorization for Transplants
Provisions of the Proposed Rule: Wishing to protect beneficiaries
and providers from significant financial risks as a result of
noncovered care related to organ transplantation and to ensure the
prudent expenditure of public funds, the proposed rule established
preauthorization requirements for: (1) High dose chemotherapy and stem
cell transplantation; (2) all initial and retransplanted solid organs,
except kidney and cornea; and (3) advanced life support air ambulance
and certified advanced life support attendant for lung or heart-lung
candidates.
Analysis of Major Public Comments. One commentor expressed concern
regarding the proposed preauthorization time requirement for organ
transplants occur ``not fewer than two business days prior to the
planned admission.''
Response: The reference to ``not fewer than two business days prior
to the planned admission'' was removed prior to publication of the
proposed rule in the Federal Register.
Provisions of the Final Rule: The paragraph on preauthorization
requirements at Paragraph (e)(5)(ii) has been removed from the final
rule, as preauthorization procedures are outlined in Sec. 199.7
(f)(1)(ii) and Sec. 199.15 (b)(4)(ii)(C).
3. Coverage of Cardiac Rehabilitation for Those Patients who have had
Heart-Valve Surgery, Heart or Heart-Lung Transplantation
Provisions of the Proposed Rule. TRICARE coverage of cardiac
rehabilitation for those patients who have had heart-valve surgery,
heart or heart-lung transplantation is based on an assessment conducted
by the AHCPR on ``Cardiac Rehabilitation Programs: Heart Transplant,
Percutaneous Transluminal Coronary Angioplasty, and Heart Valve Surgery
Patient'', establishing cardiac rehabilitation programs as safe and
effective for these patients.
Analysis of Major Public Comments. One commentor suggested we make
reference to AHCPR's assessment on cardiac rehabilitation programs if
TMA, formerly OCHAMPUS, used the assessment in arriving at the decision
to expand the cardiac rehabilitation benefit.
Response: It is hereby noted that TMA, formerly OCHAMPUS, did use
the AHCPR's assessment in arriving at the decision to expand the
cardiac rehabilitation benefit to include those patients who have had
heart-valve surgery, heart or heart-lung transplantation.
Provisions of the Final Rule. The final rule is consistent with the
proposed rule.
4. Recognizing Certain Transplant Centers as Authorized TRICARE
Institutional Providers
Provisions of the Proposed Rule. The proposed rule outlined
specific requirements for those institutional providers who wish to be
certified as a TRICARE approved organ transplant center for heart-lung
and single or double lung transplantation.
Analysis of Major Public Comments. One commentor questioned if
there is a time period for which the liver transplant center should
``have at least a 70 percent one year actuarial survival rate . . .?'
Response: The transplant center should have a 70 percent actuarial
survival rate based on the preceding 12-month period.
Provisions of the Final Rule: When the CHAMPUS final rules on Liver
and Heart Transplants were published in 1986, there were not very many
institutional providers performing these transplants, therefore,
detailed procedures for qualifying as a CHAMPUS-approved heart or liver
transplant center were published in 32 CFR, Section Sec. 199.6
(b)(4)(ii) and (b)(4)(iii). As stated above, the purpose of the Code of
Federal Regulations is to provide broad guidelines and policies; the
publishing of detailed guidelines in Sec. 199.6 (b)(4)(ii) and
(b)(4)(iii) for heart and liver transplant centers has proved difficult
to maintain. For example, the one year actuarial survival rate for
liver transplants is currently over 70 percent, whereas Sec. 199.6
(b)(4)(ii)(A)(3) states a liver transplant center must have at least a
50 percent one-year survival rate for ten cases. Publishing the
required actuarial survival rates in the CFR does not allow the
flexibility of easily updating the survival percentages as they
improve, thus assuring our beneficiaries receive transplants at centers
meeting the current actuarial survival rates. The certification
requirements for transplant centers have more appropriately been placed
in the TRICARE/CHAMPUS Policy Manual. The TRICARE/CHAMPUS Policy Manual
contains operational policy necessary to efficiently implement the 32
CFR part 199. The TRICARE/CHAMPUS Policy Manual augments the 32 CFR
part 199 and must be used in conjunction with the CFR for complete
[[Page 42720]]
policy information. The TRICARE/CHAMPUS Policy Manual can be accessed
through TRICARE's Web site at www.tricare.osd.mil. Sec. 199.6
(b)(4)(ii) provides broad policy guidelines for approving organ
transplant centers.
5. Pediatric Consortium Program for Organ Transplantation
Provisions of the Proposed Rule: The proposed rule allows TRICARE
to recognize pediatric facilities as authorized transplant centers when
they belong to a pediatric consortium program whose combined experience
and survival data meet the TRICARE criteria for qualifying as a
certified TRICARE organ transplant center.
Analysis of Major Public Comment: Several commentors expressed
concern about TRICARE's approach to consortium programs. One commentor
asked us to explain the basis for differences between TRICARE and CMS,
formerly HCFA, in our decision to certify as an authorized
institutional provider those individual facilities that qualify only on
the basis of combined experience and survival rates of a consortium.
The commentor explained CMS, formerly HCFA, requires the individual
facilities of a consortia meet these criteria separately.
Response: We failed to make clear in the language of the proposed
rule that the consortium concept is being advocated on the part of
pediatric transplantation centers. Our rationale for certifying
individual pediatric facilities on the basis of combined experience and
survival rates of a consortium is because pediatric facilities
performing organ transplants are generally not able to meet TRICARE
standards for certification as an authorized transplant center because
of the number of transplants performed. Since TRICARE's beneficiary
population is younger than Medicare's we needed to develop a process to
recognize pediatric facilities as TRICARE authorized transplant
centers.
Provisions of the Final Rule: As stated above, the certification
requirements for transplant centers, including pediatric organ
transplant centers have more appropriately been placed in the TRICARE/
CHAMPUS Policy Manual. Sec. 199.6 (b)(4)(iii) provides broad policy
guidelines for approving individual pediatric organ transplant centers.
6. Exception to the Ambulance Benefit
Provisions of the Proposed Rule. The proposed rule allows an
exception to the requirement that patients be transported to the
closest appropriate facility when the patient is an organ
transplantation candidate to be transported to a certified TRICARE
organ transplant center.
Provisions of the Final Rule. Since publication of the proposed
rule, military health care has undergone major reforms from a dual
delivery system consisting of direct military treatment and civilian
health care, to a fully integrated managed health care system; it is no
longer appropriate to restrict coverage/payment of MTF ordered
ambulance transfers. Based on this, the payment restrictions for MTF
ordered ambulance transfers is being eliminated from the final rule
language.
7. Coverage of Pulmonary Rehabilitation
Provisions of the Proposed Rule. The proposed rule extends coverage
for pulmonary rehabilitation for beneficiaries whose conditions are
considered appropriate according to guidelines adopted by the Executive
Director, TMA, or a designee.
Provisions of the Final Rule. The final rule is consistent with the
proposed rule.
8. Miscellaneous Provisions
Analysis of Major Comment: One commentor states CHAMPUS is not
exempt from the Paperwork Reduction Act on the grounds that hospitals
would not find the reporting intrusive. The commentor informs us the
law allows no such exception.
Response: The commentor is correct. The TMA is aware of the
Paperwork Reduction Act requirements. The Paperwork Reduction Act
requirements do not apply in this case as the collection of information
is standardized and will affect less than nine entities per year.
III. Regulatory Procedures
Executive Order 12866 requires that a regulatory impact analysis be
performed on any major rule. A ``major rule'' is defined as one that
would result in the annual effect on the national economy of $100
million or more, or have other substantial impact. The Regulatory
Flexibility Act (RFA) requires that each Federal Agency prepare, and
make available for public comment, a regulatory flexibility analysis
when the agency issues regulations which would have a significant
impact on a substantial number of small entities.
This final rule is not major rule under the Congressional Review
Act. The changes set forth in this final rule are minor revisions to
existing regulation. The changes made in this final rule involve an
expansion of TRICARE benefits. In addition, this final rule will have
minor impact and will not significantly affect a substantial number of
small entities. In light of the above, no regulatory impact analysis is
required.
The rule has been designated as significant and has been reviewed
by the Office of Management and Budget as required under the provisions
of Executive Order 12866.
The final rule will not impose additional information collection
requirements on the public under the Paperwork Reduction Act of 1995
(44 U.S.C. Chapter 55).
List of Subjects in 32 CFR Part 199
Claims, Health insurance, Individuals with disabilities, Military
personnel.
Accordingly, 32 CFR Part 199 is amended as follows:
PART 199--[AMENDED]
1. The authority citation for part 199 continues to read as
follows:
Authority: 5 U.S.C. 301; 10 U.S.C. chapter 55.
2. Section 199.4 is amended as follows:
a. Revise paragraph (d)(3)(v) introductory text preceding the Note;
b. Remove paragraph (d)(3)(v)(A);
c. Redesignate paragraphs (d)(3)(v)(B) and (d)(3)(v)(D) as
(d)(3)(v)(A) through (d)(3)(v)(C);
d. Revise newly designated paragraphs (d)(3)(v)(A) and
(d)(3)(v)(C);
e. Revise paragraph (e)(5); and
f. Add paragraphs (e)(18)(i)(F), (e)(18)(i)(G) and (e)(21).
The additions and revisions read as follows:
Sec. 199.4 Basic program benefits.
* * * * *
(d) * * *
(3) * * *
(v) Ambulance. Civilian ambulance service is covered when medically
necessary in connection with otherwise covered services and supplies
and a covered medical condition. For the purpose of TRICARE payment,
ambulance service is an outpatient service (including in connection
with maternity care) with the exception of otherwise covered transfers
between hospitals which are cost-shared on an inpatient basis.
Ambulance transfers from a hospital based emergency room to another
hospital more capable of providing the required care will also be cost-
shared on an inpatient basis.
* * * * *
(A) Ambulance service cannot be used instead of taxi service and is
not payable when the patient's condition would have permitted use of
regular private transportation; nor is it payable when
[[Page 42721]]
transport or transfer of a patient is primarily for the purpose of
having the patient nearer to home, family, friends, or personal
physician. Except as described in paragraph (d)(3)(v)(C)(1) of this
section transport must be to the closest appropriate facility by the
least costly means.
* * * * *
(C) Except as described in paragraph (d)(3)(v)(C)(1)(1) of this
section, ambulance services by other than land vehicles (such as a boat
or airplane) may be considered only when the pickup point is
inaccessible by a land vehicle, or when great distance or other
obstacles are involved in transporting the patient to the nearest
hospital with appropriate facilities and the patient's medical
condition warrants speedy admission or is such that transfer by other
means is contraindicated.
(1) Advanced life support air ambulance and certified advanced life
support attendant are covered services for solid organ and stem cell
transplant candidates.
(2) Advanced life support air ambulance and certified advanced life
support attendant shall be reimbursed subject to standard reimbursement
methodologies.
* * * * *
(e) * * *
(5) Transplants. (i) Organ transplants. Basic Program benefits are
available for otherwise covered services or supplies in connection with
an organ transplant procedure, provided such transplant procedure is in
accordance with accepted professional medical standards and is not
considered unproven.
(A) General. (1) Benefits may be allowed for medically necessary
services and supplies related to an organ transplant for:
(i) Evaluation of potential candidate's suitability for an organ
transplant, whether or not the patient is ultimately accepted as a
candidate for transplant.
(ii) Pre- and post-transplant inpatient hospital and outpatient
services.
(iii) Pre- and post-operative services of the transplant team.
(iv) Blood and blood products.
(v) FDA approved immunosuppression drugs to include off-label uses
when determined to be medically necessary for the treatment of the
condition for which it is administered, according to accepted standards
of medical practice.
(vi) Complications of the transplant procedure, including inpatient
care, management of infection and rejection episodes.
(vii) Periodic evaluation and assessment of the successfully
transplanted patient.
(viii) The donor acquisition team, including the costs of
transportation to the location of the donor organ and transportation of
the team and the donated organ to the location of the transplant
center.
(ix) The maintenance of the viability of the donor organ after all
existing legal requirements for excision of the donor organ have been
met.
(2) TRICARE benefits are payable for recipient costs when the
recipient of the transplant is a CHAMPUS beneficiary, whether or not
the donor is a CHAMPUS beneficiary.
(3) Donor costs are payable when:
(i) Both the donor and recipient are CHAMPUS beneficiaries.
(ii) The donor is a CHAMPUS beneficiary but the recipient is not.
(iii) The donor is the sponsor and the recipient is a CHAMPUS
beneficiary. (In such an event, donor costs are paid as a part of the
beneficiary and recipient costs.)
(iv) The donor is neither a CHAMPUS beneficiary nor a sponsor, if
the recipient is a CHAMPUS beneficiary. (Again, in such an event, donor
costs are paid as a part of the beneficiary and recipient costs.)
(4) If the donor is not a CHAMPUS beneficiary, TRICARE benefits for
donor costs are limited to those directly related to the transplant
procedure itself and do not include any medical care costs related to
other treatment of the donor, including complications.
(5) TRICARE benefits will not be allowed for transportation of an
organ donor.
(B) [Reserved]
(ii) Stem cell transplants. TRICARE benefits are payable for
beneficiaries whose conditions are considered appropriate for stem cell
transplant according to guidelines adopted by the Executive Director,
TMA, or a designee.
* * * * *
(18) * * *
(i) * * *
(F) Heart valve surgery.
(G) Heart or Heart-lung Transplantation.
* * * * *
(21) Pulmonary rehabilitation. TRICARE benefits are payable for
beneficiaries whose conditions are considered appropriate for pulmonary
rehabilitation according to guidelines adopted by the Executive
Director, TMA, or a designee.
* * * * *
3. Section 199.6 is amended by revising paragraphs (b)(4)(ii) and
(b)(4)(iii) to read as follows:
Sec. 199.6 Authorized providers.
* * * * *
(b) * * *
(4) * * *
(ii) Organ transplant centers. To obtain TRICARE approval as an
organ transplant center, the center must be a Medicare approved
transplant center or meet the criteria as established by the Executive
Director, TMA, or a designee.
(iii) Organ transplant consortia. TRICARE shall approve individual
pediatric organ transplant centers that meet the criteria established
by the Executive Director, TMA, or a designee.
* * * * *
4. Section 199.7 is amended by revising paragraph (f)(1)(ii) to
read as follows:
Sec. 199.7 Claims submission, review, and payment.
* * * * *
(f) * * *
(1) * * *
(ii) Time limit on preauthorization. Approved preauthorizations are
valid for specific periods of time, appropriate for the circumstances
presented and specified at the time the preauthorization is approved.
In general, preauthorizations are valid for 30 days. If the
preauthorized service or supplies are not obtained or commenced within
the specified time limit, a new preauthorization is required before
benefits may be extended. For organ and stem cell transplants, the
preauthorization shall remain in effect as long as the beneficiary
continues to meet the specific transplant criteria set forth in the
TRICARE/CHAMPUS Policy Manual, or until the approved transplant occurs.
* * * * *
5. Section 199.15 is amended by revising paragraph (b)(4)(ii)(C) to
read as follows:
Sec. 199.15 Quality and utilization review peer review organization
program.
* * * * *
(b) * * *
(4) * * *
(ii) * * *
(C) An approved preauthorization shall state the number of days,
appropriate for the type of care involved, for which it is valid. In
general, preauthorizations will be valid for 30 days. If the services
or supplies are not obtained within the number of days specified, a new
preauthorization request is required. For organ and stem cell
transplants, the preauthorization shall remain in effect as long as the
beneficiary continues to meet the specific transplant criteria set
forth in the TRICARE/CHAMPUS Policy
[[Page 42722]]
Manual, or until the approved transplant occurs.
* * * * *
Dated: June 11, 2002.
L.M. Bynum,
Alternate Federal Register Liaison Officer, Department of Defense.
[FR Doc. 02-15220 Filed 6-24-02; 8:45 am]
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