[Federal Register Volume 68, Number 5 (Wednesday, January 8, 2003)]
[Rules and Regulations]
[Pages 1009-1013]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-101]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AK88


Health Care for Certain Children of Vietnam Veterans--Covered 
Birth Defects and Spina Bifida

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

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SUMMARY: This document amends the regulations regarding health care for 
Vietnam veterans' children suffering from spina bifida to also 
encompass health care for women Vietnam veterans' children with certain 
other birth defects. This is necessary to provide health care for such 
children in accordance with recently enacted legislation. The 
amendments also reduce the requirements for preauthorization, reflect 
changes in organizational and personnel titles, revise contact 
information for the VHA Health Administration Center, and make 
nonsubstantive changes for purposes of clarity.

DATES: Effective Date: January 8, 2003.
    Applicability Dates: This rule is applicable retroactively to 
December 1, 2001, for benefits added by Public Law 106-419. For more 
information concerning the dates of applicability, see the 
SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Susan Schmetzer, Chief, Policy & 
Compliance Division, Health Administration Center, Department of 
Veterans Affairs, PO Box 65020, Denver, CO 80206, telephone (303) 331-
7552.

SUPPLEMENTARY INFORMATION: In a document published in the Federal 
Register on January 2, 2002 (67 FR 209), we proposed to amend VA health 
care regulations to provide benefits for women Vietnam veterans' 
children with covered birth defects, reduce the requirements for 
preauthorization, reflect changes in organizational and personnel 
titles, revise contact information for the VHA Health Administration 
Center, and make nonsubstantive changes for purposes of clarity. Prior 
to the enactment of Public Law 106-419 on November 1, 2000, the 
provisions of 38 U.S.C. chapter 18 only concerned benefits for children 
with spina bifida who were born to Vietnam veterans. Effective December 
1, 2001, section 401 of Public Law 106-419 amended 38 U.S.C. chapter 18 
to add benefits for women Vietnam veterans' children with certain birth 
defects (referred to as ``covered birth defects'').
    Two companion proposed rule documents concerning the provision of 
benefits under that legislation were also set forth in the January 2, 
2002, issue of the Federal Register. One concerned monetary allowances 
and the identification of covered birth defects (RIN: 2900-AK67) (67 FR 
200). The other concerned the provision of vocational training benefits 
(RIN: 2900-AK90) (67 FR 215). With respect to the first document, we 
published a final rule entitled ``Monetary Allowances for Certain 
Children of Vietnam Veterans; Identification of Covered Birth Defects'' 
in the July 31, 2002, issue of the Federal Register (67 FR 49585).
    For the proposed rule on health care, we provided, except for the 
information collection provisions, a thirty-day period for public 
comments, which ended on February 1, 2002. Pursuant to the Paperwork 
Reduction Act, we provided for the information collections in the 
document a 60-day comment period, which ended on March 4, 2002. We 
received comments from one organization and two individuals. None of 
the comments concerned the information collections.
    One commenter, an individual, felt that the U.S. government is 
displaying a bias in favor of women veterans in this regulation and 
that the hidden effect of Agent Orange may also have remained dormant 
in men's systems and produced chromosomal disorders in their children. 
No changes are made based on this comment. Public Law 106-419, which 
was based on a comprehensive health study conducted by VA of 8,280 
women Vietnam-era veterans, provides benefits specifically for women 
Vietnam veterans' children with certain birth defects. We have no legal 
authority to award the new health care benefits to children of male 
Vietnam veterans.
    Another individual commented about payment of transportation 
expenses for medical care and treatment, and suggested two changes to 
the regulations. First, he suggested a change that he said would 
clarify Sec.  17.902(a), which in the first sentence requires 
preauthorization for certain travel and other benefits. In our view, 
his suggested change would not be merely a clarification but rather 
would be a substantive change to the benefits paid for travel of 
beneficiaries and any necessary attendants. The proposed rule contained 
the same language concerning travel as in the current regulations in 38 
CFR part 17 for health care for Vietnam veterans' children with spina 
bifida. We believe that a substantive change to travel benefits is 
beyond the scope of this rulemaking.
    Second, this commenter suggested that Sec.  17.903, concerning 
payment, be amended to contain specific provisions about travel 
benefits. The commenter's suggested language would, in part, 
unnecessarily restate statutory provisions that are already reflected 
in the language in proposed Sec.  17.900, which defines ``health care'' 
as including ``direct transportation costs to and from approved health 
care providers (including any necessary costs for meals and lodging en 
route, and accompaniment by an attendant or attendants).'' Also, his 
suggested language would add substantive

[[Page 1010]]

provisions on travel. As discussed above, a substantive change to 
travel benefits is beyond the scope of this rulemaking.
    A comment was received from the Spina Bifida Association of America 
requesting that the regulations be changed to reflect VA as a primary 
payer rather than the exclusive payer for covered services. The 
commenter asserted that as an unintended consequence of the ``exclusive 
payer'' language (in the current 38 CFR 17.900 and in the proposed rule 
in Sec.  17.901), health care providers are sometimes unwilling to 
provide care covered by the regulations because coordination of 
benefits with other health insurers (and resulting additional payments 
to the providers for their services) is not allowed. Because the 
requested change is significant and substantive in nature, it is beyond 
the scope of this rulemaking. However, the Department is considering 
the need for such a change.
    Based on the rationale set forth in the proposed rule and in this 
document, we are adopting the provisions of the proposed rule as a 
final rule without change except that we are making nonsubstantive 
changes for purposes of clarity and we are adding a statement following 
each of the sections in the rule with information collection 
requirements to reflect the approval by the Office of Management and 
Budget (OMB) of the information collection requirements contained in 
those sections.

Administrative Procedure Act

    This rule provides for new benefits and otherwise merely removes 
restrictions on benefits and makes nonsubstantive changes. To avoid 
delay in furnishing the new benefits, we find that there is good cause 
to make this final rule effective without a 30-day delay of its 
effective date. Accordingly, under 5 U.S.C. 553, there is no need for 
delay in this rule's effective date.

Applicability Dates

    This rule is applicable retroactively to the statutory effective 
date of December 1, 2001, for benefits added by section 401 of Public 
Law 106-419. This rule is otherwise applicable on the rule's effective 
date, January 8, 2003, for the already existing program of health care 
furnished for Vietnam veterans' children determined under 38 CFR 3.814 
to suffer from spina bifida.

Paperwork Reduction Act

    Information collection requirements associated with this final rule 
(in 38 CFR 17.902 through 17.904) have been approved by OMB under the 
provisions of the Paperwork Reduction Act (44 U.S.C. 3501-3521) and 
have been assigned OMB control number 2900-0578. The information 
collection requirements of Sec.  17.902 concern requests for 
preauthorization for certain health care services or benefits. The 
information collection requirements of Sec.  17.903 concern the 
submission of claims from approved health care providers for health 
care provided under Sec. Sec.  17.900 through 17.905. The information 
collection requirements of Sec.  17.904 concern the review and appeal 
process regarding provision of health care, or payment relating to 
provision of health care, under Sec. Sec.  17.900 through 17.905.
    OMB assigns a control number for each collection of information it 
approves. VA may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number.

Executive Order 12866

    This document has been reviewed by the Office of Management and 
Budget under Executive Order 12866.

Regulatory Flexibility Act

    The Secretary hereby certifies that the adoption of the rule will 
not have a significant impact on a substantial number of small entities 
as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-
612. It is estimated that there are only a total of 1200 Vietnam 
veterans' children who suffer from spina bifida and women Vietnam 
veterans' children who suffer from covered birth defects. They are 
widely geographically diverse and the health care provided to them 
would not have a significant impact on any small businesses. Therefore, 
pursuant to 5 U.S.C. 605(b), this document is exempt from the initial 
and final regulatory flexibility analysis requirements of sections 603 
and 604.

Unfunded Mandates

    The Unfunded Mandates Reform Act requires, at 2 U.S.C. 1532, that 
agencies prepare an assessment of anticipated costs and benefits before 
developing any rule that may result in an expenditure by State, local, 
or tribal governments, in the aggregate, or by the private sector, of 
$100 million or more in any given year. This rule will have no 
consequential effect on State, local, or tribal governments.

Catalog of Federal Domestic Assistance

    There are no Catalog of Federal Domestic Assistance program numbers 
for the programs affected by this document.

List of Subjects in 38 CFR Part 17

    Administrative practice and procedure, Alcohol abuse, Alcoholism, 
Claims, Day care, Dental health, Drug abuse, Foreign relations, 
Government contracts, Grant programs-health, Grant programs-veterans, 
Health care, Health facilities, Health professions, Health records, 
Homeless, Medical and dental schools, Medical devices, Medical 
research, Mental health programs, Nursing homes, Philippines, Reporting 
and record keeping requirements, Scholarships and fellowships, Travel 
and transportation expenses, Veterans.

    Approved: September 25, 2002.
Anthony J. Principi,
Secretary of Veterans Affairs.

    For the reasons set forth in the preamble, 38 CFR part 17 is 
amended as follows:

PART 17--MEDICAL

    1. The authority citation for part 17 continues to read as follows:

    Authority: 38 U.S.C. 501(a), 1721, unless otherwise noted.

    2. In part 17, the undesignated center heading immediately 
preceding Sec.  17.900 and Sec. Sec.  17.900 through 17.905 are revised 
to read as follows:

Health Care Benefits for Certain Children of Vietnam Veterans--Spina 
Bifida and Covered Birth Defects


Sec.  17.900  Definitions.

    For purposes of Sec. Sec.  17.900 through 17.905--
    Approved health care provider means a health care provider 
currently approved by the Center for Medicare and Medicaid Services 
(CMS), Department of Defense TRICARE Program, Civilian Health and 
Medical Program of the Department of Veterans Affairs (CHAMPVA), Joint 
Commission on Accreditation of Health Care Organizations (JCAHO), or 
currently approved for providing health care under a license or 
certificate issued by a governmental entity with jurisdiction. An 
entity or individual will be deemed to be an approved health care 
provider only when acting within the scope of the approval, license, or 
certificate.
    Child for purposes of spina bifida means the same as individual as 
defined at Sec.  3.814(c)(2) or Sec.  3.815(c)(2) of this title and for 
purposes of covered birth defects means the same as individual as 
defined at Sec.  3.815(c)(2) of this title.
    Covered birth defect means the same as defined at Sec.  3.815(c)(3) 
of this title and also includes complications or

[[Page 1011]]

medical conditions that are associated with the covered birth defect(s) 
according to the scientific literature.
    Habilitative and rehabilitative care means such professional, 
counseling, and guidance services and such treatment programs (other 
than vocational training under 38 U.S.C. 1804 or 1814) as are necessary 
to develop, maintain, or restore, to the maximum extent practicable, 
the functioning of a disabled person.
    Health care means home care, hospital care, nursing home care, 
outpatient care, preventive care, habilitative and rehabilitative care, 
case management, and respite care; and includes the training of 
appropriate members of a child's family or household in the care of the 
child; and the provision of such pharmaceuticals, supplies (including 
continence-related supplies such as catheters, pads, and diapers), 
equipment (including durable medical equipment), devices, appliances, 
assistive technology, direct transportation costs to and from approved 
health care providers (including any necessary costs for meals and 
lodging en route, and accompaniment by an attendant or attendants), and 
other materials as the Secretary determines necessary.
    Health care provider means any entity or individual that furnishes 
health care, including specialized clinics, health care plans, 
insurers, organizations, and institutions.
    Home care means medical care, habilitative and rehabilitative care, 
preventive health services, and health-related services furnished to a 
child in the child's home or other place of residence.
    Hospital care means care and treatment furnished to a child who has 
been admitted to a hospital as a patient.
    Nursing home care means care and treatment furnished to a child who 
has been admitted to a nursing home as a resident.
    Outpatient care means care and treatment, including preventive 
health services, furnished to a child other than hospital care or 
nursing home care.
    Preventive care means care and treatment furnished to prevent 
disability or illness, including periodic examinations, immunizations, 
patient health education, and such other services as the Secretary 
determines necessary to provide effective and economical preventive 
health care.
    Respite care means care furnished by an approved health care 
provider on an intermittent basis for a limited period to an individual 
who resides primarily in a private residence when such care will help 
the individual continue residing in such private residence.
    Spina bifida means all forms and manifestations of spina bifida 
except spina bifida occulta (this includes complications or medical 
conditions that are associated with spina bifida according to the 
scientific literature).
    Vietnam veteran for purposes of spina bifida means the same as 
defined at Sec.  3.814(c)(1) or Sec.  3.815(c)(1) of this title and for 
purposes of covered birth defects means the same as defined at Sec.  
3.815(c)(1) of this title.

(Authority: 38 U.S.C. 101(2), 1802-1803, 1811-1813, 1821)


Sec.  17.901  Provision of health care.

    (a) Spina bifida. VA will provide a Vietnam veteran's child who has 
been determined under Sec.  3.814 or Sec.  3.815 of this title to 
suffer from spina bifida with such health care as the Secretary 
determines is needed by the child for spina bifida. VA may inform spina 
bifida patients, parents, or guardians that health care may be 
available at not-for-profit charitable entities.
    (b) Covered birth defects. VA will provide a woman Vietnam 
veteran's child who has been determined under Sec.  3.815 of this title 
to suffer from spina bifida or other covered birth defects with such 
health care as the Secretary determines is needed by the child for the 
covered birth defects. However, if VA has determined for a particular 
covered birth defect that Sec.  3.815(a)(2) of this title applies 
(concerning affirmative evidence of cause other than the mother's 
service during the Vietnam era), no benefits or assistance will be 
provided under this section with respect to that particular birth 
defect.
    (c) Providers of care. Health care provided under this section will 
be provided directly by VA, by contract with an approved health care 
provider, or by other arrangement with an approved health care 
provider.
    (d) Submission of information. For purposes of Sec. Sec.  17.900 
through 17.905:
    (1) The telephone number of the Health Administration Center is 
(888) 820-1756;
    (2) The facsimile number of the Health Administration Center is 
(303) 331-7807;
    (3) The hand-delivery address of the Health Administration Center 
is 300 S. Jackson Street, Denver, CO 80209; and
    (4) The mailing address of the Health Administration Center--
    (i) For spina bifida is P.O. Box 65025, Denver, CO 80206-9025; and
    (ii) For covered birth defects is P.O. Box 469027, Denver, CO 
80246-0027.

(Authority: 38 U.S.C. 101(2), 1802-1803, 1811-1813, 1821)

    Note to Sec.  17.901: This is not intended to be a comprehensive 
insurance plan and does not cover health care unrelated to spina 
bifida or unrelated to covered birth defects. VA is the exclusive 
payer for services paid under Sec. Sec.  17.900 through 17.905 
regardless of any third party insurer, Medicare, Medicaid, health 
plan, or any other plan or program providing health care coverage. 
Any third-party insurer, Medicare, Medicaid, health plan, or any 
other plan or program providing health care coverage would be 
responsible according to its provisions for payment for health care 
not relating to spina bifida or covered birth defects.

Sec.  17.902  Preauthorization.

    (a) Preauthorization from a benefits advisor of the Health 
Administration Center is required for the following services or 
benefits under Sec. Sec.  17.900 through 17.905: rental or purchase of 
durable medical equipment with a total rental or purchase price in 
excess of $300, respectively; transplantation services; mental health 
services; training; substance abuse treatment; dental services; and 
travel (other than mileage at the General Services Administration rate 
for privately owned automobiles). Authorization will only be given in 
those cases where there is a demonstrated medical need related to the 
spina bifida or covered birth defects. Requests for provision of health 
care requiring preauthorization shall be made to the Health 
Administration Center and may be made by telephone, facsimile, mail, or 
hand delivery. The application must contain the following:
    (1) Name of child,
    (2) Child's Social Security number,
    (3) Name of veteran,
    (4) Veteran's Social Security number,
    (5) Type of service requested,
    (6) Medical justification,
    (7) Estimated cost, and
    (8) Name, address, and telephone number of provider.
    (b) Notwithstanding the provisions of paragraph (a) of this 
section, preauthorization is not required for a condition for which 
failure to receive immediate treatment poses a serious threat to life 
or health. Such emergency care should be reported by telephone to the 
Health Administration Center within 72 hours of the emergency.

(Authority: 38 U.S.C. 101(2), 1802-1803, 1811-1813, 1821)

(The Office of Management and Budget has approved the information 
collection requirements in this section under control number 2900-
0578.)


Sec.  17.903  Payment.

    (a)(1) Payment for services or benefits under Sec. Sec.  17.900 
through 17.905 will be determined utilizing the same payment 
methodologies as provided for under the

[[Page 1012]]

Civilian Health and Medical Program of the Department of Veterans 
Affairs (CHAMPVA) (see Sec.  17.270).
    (2) As a condition of payment, the services must have occurred:
    (i) For spina bifida, on or after October 1, 1997, and must have 
occurred on or after the date the child was determined eligible for 
benefits under Sec.  3.814 of this title.
    (ii) For covered birth defects, on or after December 1, 2001, and 
must have occurred on or after the date the child was determined 
eligible for benefits under Sec.  3.815 of this title.
    (3) Claims from approved health care providers must be filed with 
the Health Administration Center in writing (facsimile, mail, hand 
delivery, or electronically) no later than:
    (i) One year after the date of service; or
    (ii) In the case of inpatient care, one year after the date of 
discharge; or
    (iii) In the case of retroactive approval for health care, 180 days 
following beneficiary notification of eligibility.
    (4) Claims for health care provided under the provisions of 
Sec. Sec.  17.900 through 17.905 must contain, as appropriate, the 
information set forth in paragraphs (a)(4)(i) through (a)(4)(v) of this 
section.
    (i) Patient identification information:
    (A) Full name,
    (B) Address,
    (C) Date of birth, and
    (D) Social Security number.
    (ii) Provider identification information (inpatient and outpatient 
services):
    (A) Full name and address (such as hospital or physician),
    (B) Remittance address,
    (C) Address where services were rendered,
    (D) Individual provider's professional status (M.D., Ph.D., R.N., 
etc.), and
    (E) Provider tax identification number (TIN) or Social Security 
number.
    (iii) Patient treatment information (long-term care or 
institutional services):
    (A) Dates of service (specific and inclusive),
    (B) Summary level itemization (by revenue code),
    (C) Dates of service for all absences from a hospital or other 
approved institution during a period for which inpatient benefits are 
being claimed,
    (D) Principal diagnosis established, after study, to be chiefly 
responsible for causing the patient's hospitalization,
    (E) All secondary diagnoses,
    (F) All procedures performed,
    (G) Discharge status of the patient, and
    (H) Institution's Medicare provider number.
    (iv) Patient treatment information for all other health care 
providers and ancillary outpatient services such as durable medical 
equipment, medical requisites, and independent laboratories:
    (A) Diagnosis,
    (B) Procedure code for each procedure, service, or supply for each 
date of service, and
    (C) Individual billed charge for each procedure, service, or supply 
for each date of service.
    (v) Prescription drugs and medicines and pharmacy supplies:
    (A) Name and address of pharmacy where drug was dispensed,
    (B) Name of drug,
    (C) National Drug Code (NDC) for drug provided,
    (D) Strength,
    (E) Quantity,
    (F) Date dispensed,
    (G) Pharmacy receipt for each drug dispensed (including billed 
charge), and
    (H) Diagnosis for which each drug is prescribed.
    (b) Health care payment will be provided in accordance with the 
provisions of Sec. Sec.  17.900 through 17.905. However, the following 
are specifically excluded from payment:
    (1) Care as part of a grant study or research program,
    (2) Care considered experimental or investigational,
    (3) Drugs not approved by the U.S. Food and Drug Administration for 
commercial marketing,
    (4) Services, procedures, or supplies for which the beneficiary has 
no legal obligation to pay, such as services obtained at a health fair,
    (5) Services provided outside the scope of the provider's license 
or certification, and
    (6) Services rendered by providers suspended or sanctioned by a 
Federal agency.
    (c) Payments made in accordance with the provisions of Sec. Sec.  
17.900 through 17.905 shall constitute payment in full. Accordingly, 
the health care provider or agent for the health care provider may not 
impose any additional charge for any services for which payment is made 
by VA.
    (d) Explanation of benefits (EOB).--(1) When a claim under the 
provisions of Sec. Sec.  17.900 through 17.905 is adjudicated, an EOB 
will be sent to the beneficiary or guardian and the provider. The EOB 
provides, at a minimum, the following information:
    (i) Name and address of recipient,
    (ii) Description of services and/or supplies provided,
    (iii) Dates of services or supplies provided,
    (iv) Amount billed,
    (v) Determined allowable amount,
    (vi) To whom payment, if any, was made, and
    (vii) Reasons for denial (if applicable).
    (2) [Reserved]

(Authority: 38 U.S.C. 101(2), 1802-1803, 1811-1813, 1821)

(The Office of Management and Budget has approved the information 
collection requirements in this section under control number 2900-
0578.)

Sec.  17.904  Review and appeal process.

    For purposes of Sec. Sec.  17.900 through 17.905, if a health care 
provider, child, or representative disagrees with a determination 
concerning provision of health care or with a determination concerning 
payment, the person or entity may request reconsideration. Such request 
must be submitted in writing (by facsimile, mail, or hand delivery) 
within one year of the date of the initial determination to the Health 
Administration Center (Attention: Chief, Benefit and Provider 
Services). The request must state why it is believed that the decision 
is in error and must include any new and relevant information not 
previously considered. Any request for reconsideration that does not 
identify the reason for dispute will be returned to the sender without 
further consideration. After reviewing the matter, including any 
relevant supporting documentation, a benefits advisor will issue a 
written determination (with a statement of findings and reasons) to the 
person or entity seeking reconsideration that affirms, reverses, or 
modifies the previous decision. If the person or entity seeking 
reconsideration is still dissatisfied, within 90 days of the date of 
the decision he or she may submit in writing (by facsimile, mail, or 
hand delivery) to the Health Administration Center (Attention: 
Director) a request for review by the Director, Health Administration 
Center. The Director will review the claim and any relevant supporting 
documentation and issue a decision in writing (with a statement of 
findings and reasons) that affirms, reverses, or modifies the previous 
decision. An appeal under this section would be considered as filed at 
the time it was delivered to the VA or at the time it was released for 
submission to the VA (for example, this could be evidenced by the 
postmark, if mailed).

    Note to Sec.  17.904: The final decision of the Director will 
inform the claimant of further appellate rights for an appeal to the 
Board of Veterans' Appeals.

(Authority: 38 U.S.C. 101(2), 1802-1803, 1811-1813, 1821)


[[Page 1013]]


(The Office of Management and Budget has approved the information 
collection requirements in this section under control number 2900-
0578.)

Sec.  17.905  Medical records.

    Copies of medical records generated outside VA that relate to 
activities for which VA is asked to provide payment or that VA 
determines are necessary to adjudicate claims under Sec. Sec.  17.900 
through 17.905 must be provided to VA at no cost.

(Authority: 38 U.S.C. 101(2), 1802-1803, 1811-1813, 1821)

[FR Doc. 03-101 Filed 1-7-03; 8:45 am]
BILLING CODE 8320-01-P