[Federal Register Volume 67, Number 1 (Wednesday, January 2, 2002)]
[Proposed Rules]
[Pages 209-214]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-31674]


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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: Proposed rule.

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SUMMARY: This document proposes to establish regulations regarding 
health care benefits for women Vietnam veterans' children with covered 
birth defects. It would revise the current 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 revisions 
would 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. Companion documents 
entitled ``Monetary Allowances for Certain Children of Vietnam 
Veterans; Identification of Covered Birth Defects'' (RIN 2900-AK67) and 
``Vocational Training for Certain Children of Vietnam Veterans--Covered 
Birth Defects and Spina Bifida'' (RIN 2900-AK90) are set forth in the 
Proposed Rules section of this issue of the Federal Register.

DATES: Comments must be received by VA on or before February 1, 2002, 
except that comments on the information collection provisions in this 
document must be received on or before March 4, 2002.

ADDRESSES: Mail or hand deliver written comments to: Director, Office 
of Regulations Management (02D), Room 1154, 810 Vermont Ave., NW, 
Washington, DC 20420; or fax comments to (202) 273-9289; or e-mail 
comments to <a href="/cdn-cgi/l/email-protection#91ded6d2c3f4f6e4fdf0e5f8feffe2d1fcf0f8fdbfe7f0bff6fee7"><span class="__cf_email__" data-cfemail="29666e6a7b4c4e5c45485d4046475a6944484045075f48074e465f">[email protected]</span></a>. Comments should indicate that 
they are submitted in response to ``RIN 2900-AK88.'' All comments 
received will be available for public inspection in the Office of 
Regulations Management, Room 1158, between the hours of 8 a.m. and 4:30 
p.m., Monday through Friday (except holidays). In addition, see the 
Paperwork Reduction Act heading under the SUPPLEMENTARY INFORMATION 
section of this preamble regarding submission of comments on the 
information collection provisions.

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

SUPPLEMENTARY INFORMATION: 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 amends 38 U.S.C. chapter 18 to add benefits for women Vietnam 
veterans' children with certain birth defects (referred to below as 
``covered birth defects'').
    As amended, 38 U.S.C. chapter 18 provides for three separate types 
of benefits for women Vietnam veterans' children who suffer from 
covered birth defects as well as for Vietnam veterans' children who 
suffer from spina bifida: (1) Monthly monetary allowances for various 
disability levels; (2) provision of health care needed for the child's 
spina bifida or covered birth defects; and (3) provision of vocational 
training and rehabilitation.
    This document proposes to amend VA's ``Medical'' regulations (38 
CFR part 17) by revising the regulations in Secs. 17.900 through 17.905 
concerning the provision of health care. These regulations currently 
only concern the provision of health care for Vietnam veterans' 
children with spina bifida. This document proposes to revise the 
regulations by adding women Vietnam veterans' children with covered 
birth defects to the existing regulatory framework. The revisions would 
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. As the proposed rule provides, the mailing address 
for the VHA Health Administration Center for spina bifida is P.O. Box 
65025, Denver, CO 80206-9025 and for covered birth defects is P.O. Box 
469027, Denver, CO 80246-9027.
    As a condition of eligibility for the provision of health care for 
women Vietnam veterans' children with covered birth defects, it is 
proposed that the child must be an individual determined to have a 
covered birth defect under 38 CFR 3.815. (Definitions of the terms 
individual and covered birth defect and provisions concerning

[[Page 210]]

identification of covered birth defects are included in proposed 
Sec. 3.815 set forth in the companion document concerning monetary 
allowances and identification of covered birth defects (RIN 2900-AK67) 
published in the Proposed Rules section of this issue of the Federal 
Register.)
    Consistent with the authorizing legislation, a note to the proposed 
rule explains that the proposed provisions are not intended to be a 
comprehensive insurance plan and do not cover health care unrelated to 
spina bifida and covered birth defects.
    The statutory provisions state that the Secretary may provide 
health care directly or by contract or other arrangement with any 
health care provider. VA proposes to contract or arrange for provision 
of covered health care only through approved health care providers. In 
this regard, it is proposed that such health care providers be only 
those currently approved, for the services provided, by the Center for 
Medicare and Medicaid Services (CMS), Department of Defense (DoD) 
TRICARE program, Civilian Health and Medical Program of the Department 
of Veterans Affairs (CHAMPVA), or Joint Commission on Accreditation of 
Healthcare Organizations (JCAHO), or currently approved under a license 
or certificate issued by a governmental entity with jurisdiction. This 
appears to provide reasonable assurance that individuals providing 
health care for these children under this authority are qualified to do 
so. These provisions already apply to the regulations concerning the 
provision of health care for Vietnam veterans' children with spina 
bifida, except that they reflect a title change in the Department of 
Defense program; clarify that approved health care providers include 
those issued a license or certificate by a governmental entity with 
jurisdiction; and clarify the definition of respite care by stating 
that the care must be furnished by an approved health care provider.
    The proposal includes a note clarifying when VA is the exclusive 
payer for health care provided. The note states that VA would provide 
payment under the proposal only for health care relating to spina 
bifida or covered birth defects (under the definitions of spina bifida 
and covered birth defects in proposed Sec. 17.900, this includes 
complications or medical conditions that according to the scientific 
literature are associated with spina bifida or with the covered birth 
defects). The note also states that VA is the exclusive payer for 
services authorized under this proposal regardless of any third-party 
insurer, Medicare, Medicaid, health plan, or any other plan or program 
providing health care coverage. The note further states that 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.
    It is proposed as a condition of payment that preauthorization from 
a benefits advisor of the VHA Health Administration Center be required, 
in accordance with prescribed procedures, for 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 (including any necessary costs for meals and lodging en route, 
and accompaniment by an attendant or attendants) other than mileage at 
the General Services Administration rate for privately owned 
automobiles. This will help VA provide necessary care under its 
statutory authority. Except for the following changes these 
preauthorization provisions already apply to children with spina 
bifida. The proposal would remove the requirement for preauthorization 
related to case management, home care, and respite care. The VHA Health 
Administration Center's experience has found that case management, home 
care, and respite care are approved in the vast majority of cases and 
review of these services prior to their provision has not resulted in a 
change to the overall outcome of care or expenses. Preauthorization 
would continue to be required for the rental or purchase of durable 
medical equipment, however, it is proposed that it not be required for 
the rental or purchase of equipment with a total rental or purchase 
price of $300 or less, respectively. The VHA Health Administration 
Center's experience has shown that requiring preauthorization for 
durable medical equipment with a rental or purchase price of $300 or 
less is not cost-effective for the government. The proposal also 
reflects a change in title of VHA Health Administration Center 
personnel.
    Under the proposal, payment to approved health care providers would 
be made using the methodology already established for the Civilian 
Health and Medical Program of the Department of Veterans Affairs 
(CHAMPVA) (see 38 CFR 17.270 et seq.). We believe this methodology 
based on Medicare and DoD principles would result in fair payments and 
allow VA to utilize a payment mechanism already in place. Use of the 
CHAMPVA payment methodology is currently a requirement under the 
regulations for spina bifida health care.
    It is proposed that claims from approved health care providers be 
submitted to the VHA Health Administration Center for payment and that 
the claims contain specified information. The Center already provides 
claims processing services for eligible veterans' dependents under 
CHAMPVA and the spina bifida program. The specified information is 
necessary to make determinations concerning authorization for payment.
    The proposal also includes time frames for submission of claims to 
ensure an orderly and efficient payment system. It is proposed that 
claims must be filed no later than one year after the date of service; 
or in the case of inpatient care, one year after the date of discharge; 
or in the case of retroactive approval for health care, 180 days 
following beneficiary notification of eligibility. Further, it is 
proposed that in response to a request for payment, VA will provide an 
explanation of benefits to ensure that VA determinations of payments 
would be understood by claimants. This already applies to spina bifida 
health care and is consistent with other VA health care programs for 
veterans' dependents.
    The proposal sets forth a review and appeal process concerning 
determinations relating to the provision of health care or payment. A 
note states that the final decision of the VHA Health Administration 
Center Director, concerning provision of health care or payment, will 
inform the claimant of further appellate rights for an appeal to the 
Board of Veterans' Appeals. This already applies to spina bifida health 
care, except that the review and appeal process reflects a change in 
title of an organizational unit.
    Consistent with the statutory scheme, we propose that payments made 
will constitute payment in full. Accordingly, providers will not be 
permitted to bill the patient for charges in excess of the VA-
determined allowable amount. The proposed rule also includes a specific 
list of items that would be excluded from payment since we believe they 
were not intended to be subject to payment. This already applies to 
spina bifida health care.
    The proposal includes provisions concerning medical records. It is 
proposed that 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

[[Page 211]]

Sec. Sec. 17.900 through 17.905 must be provided to VA at no charge 
when requested by VA. This already applies to spina bifida health care.

Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), 
this proposed rule contains information collections in proposed 38 CFR 
17.902 through 17.904. These sections concern the provision of certain 
health care for Vietnam veterans' children with spina bifida or 
children born with certain other birth defects to women Vietnam 
veterans. VA is proposing to revise the information collection 
currently approved by the Office of Management and Budget (OMB) under 
control number 2900-0578 to substitute the information collections in 
proposed 38 CFR 17.902 through 17.904 for the information collections 
currently approved for those sections of the regulations. Accordingly, 
under section 3507(d) of the Act VA has submitted a copy of this 
rulemaking action to OMB for its review.
    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.
    Comments on the collections of information contained in this 
proposed rule should be submitted to the Office of Management and 
Budget, Attention Desk Officer for the Department of Veterans Affairs, 
Office of Information and Regulatory Affairs, Washington, DC 20503, 
with copies sent by mail or hand delivery to the Director, Office of 
Regulations Management (02D), Department of Veterans Affairs, 810 
Vermont Ave. NW, Room 1154, Washington, DC 20420; by fax to (202) 273-
9289; or by e-mail to <a href="/cdn-cgi/l/email-protection#49060e0a1b2c2e3c25283d2026273a0924282025673f28672e263f"><span class="__cf_email__" data-cfemail="a0efe7e3f2c5c7d5ccc1d4c9cfced3e0cdc1c9cc8ed6c18ec7cfd6">[email protected]</span></a>. Comments should 
indicate that they are submitted in response to ``RIN 2900-AK88.'' All 
written comments to VA will be available for public inspection in the 
Office of Regulations Management, Room 1158, between the hours of 8 
a.m. and 4:30 p.m., Monday through Friday (except holidays).

Preauthorization--Section 17.902

    Title: Preauthorization for Provision of Health Care for Certain 
Children of Vietnam Veterans.
    Summary of collection of information: The provisions of proposed 38 
CFR 17.902 would require individuals to submit to a benefits advisor of 
the VHA Health Administration Center a preauthorization request for 
health care consisting of rental or purchase of durable medical 
equipment with a rental or purchase price in excess of $300, 
respectively; mental health services; training; substance abuse 
treatment; dental services; transplantation services; or travel (other 
than mileage at the General Services Administration rate for privately 
owned automobiles). The preauthorization request would contain the 
child's name and Social Security number; the veteran's name and Social 
Security number; the type of service requested; the medical 
justification; the estimated cost; and the name, address, and telephone 
number of the provider.
    Type of review: Revision of currently approved collection.
    Description of need for information and proposed use of 
information: Such information would be necessary to make 
preauthorization determinations in accordance with proposed 38 CFR 
17.902.
    Description of likely respondents: Individuals seeking provision of 
health care to certain children of Vietnam veterans.
    Estimated number of respondents: 400.
    Estimated frequency of responses: Occasionally.
    Estimated total annual reporting and recordkeeping burden: 200 
hours.
    Estimated burden per respondent: 30 minutes (2  x  15 minutes).

Payment of Claims--Section 17.903

    Title: Payment of Claims for Provision of Health Care for Certain 
Children of Vietnam Veterans.
    Summary of collection of information: The provisions of proposed 38 
CFR 17.903 would require that, as a condition of payment, claims from 
``approved health care providers'' for health care provided under 38 
CFR 17.900 through 17.905 must include the following information, as 
appropriate: with respect to patient identification information: the 
patient's full name, Social Security number, address, and date of 
birth; with respect to provider identification information (inpatient 
and outpatient services): full name and address (such as hospital or 
physician), remittance address, address where services were rendered, 
individual provider's professional status (M.D., Ph.D., R.N., etc.), 
and provider tax identification number (TIN) or Social Security number; 
with respect to patient treatment information (longterm care or 
institutional services): dates of service (specific and inclusive); 
summary level itemization (by revenue code); dates of service for all 
absences from a hospital or other approved institution during a period 
for which inpatient benefits are being claimed; principal diagnosis 
established, after study, to be chiefly responsible for causing the 
patient's hospitalization; all secondary diagnoses; all procedures 
performed; discharge status of the patient; and institution's Medicare 
provider number; with respect to patient treatment information for all 
other health care providers and ancillary outpatient services: 
diagnosis, procedure code for each procedure, service, or supply for 
each date of service, and individual billed charge for each procedure, 
service, or supply for each date of service; with respect to 
prescription drugs and medicines: name and address of pharmacy where 
drug was dispensed, name of drug, National Drug Code (NDC) for drug 
provided, strength, quantity, date dispensed, and pharmacy receipt for 
each drug dispensed.
    Type of review: Revision of currently approved collection.
    Description of need for information and proposed use of 
information: Such information would be necessary to make payment 
determinations in accordance with proposed 38 CFR 17.903.
    Description of likely respondents: Individuals seeking payment for 
provision of health care for certain children of Vietnam veterans.
    Estimated number of respondents: 3,000.
    Estimated frequency of responses: 10.
    Estimated total annual reporting and recordkeeping burden: 3,000 
hours.
    Estimated burden per respondent: 60 minutes (10  x  6 minutes).

Review and Appeal Process--Section 17.904

    Title: Review and Appeal Process Regarding Provision of Health Care 
or Payment Relating to Provision of Health Care for Certain Children of 
Vietnam Veterans.
    Summary of collection of information: The provisions of proposed 38 
CFR 17.904 would establish a review process regarding disagreements by 
a Vietnam veteran's child or representative with a determination 
concerning authorization of health care or a health care provider's 
disagreement with a determination regarding payment. The person or 
entity requesting reconsideration of such determination would be 
required to submit such request to the VHA Health Administration Center 
(Attention: Chief, Benefit and Provider Services), in writing within 
one year of the date of initial determination. The request must state 
why the decision is in error and include any new and relevant 
information not previously considered. After reviewing the matter, a 
benefits

[[Page 212]]

advisor would issue a written determination to the person or entity 
seeking reconsideration. If such person or entity remains dissatisfied 
with the determination, the person or entity would be permitted to make 
a written request for review by the Director, VHA Health Administration 
Center.
    Type of review: Revision of currently approved collection.
    Description of need for information and proposed use of 
information: The information proposed to be collected under Sec. 17.904 
appears to be necessary to make review and appeal determinations.
    Description of likely respondents: Beneficiaries and providers 
disagreeing with determinations regarding covered services and 
benefits.
    Estimated number of respondents: 200.
    Estimated frequency of responses: 3.
    Estimated total annual reporting and recordkeeping burden: 200 
hours.
    Estimated burden per respondent: 60 minutes (3  x  20 minutes).
    The Department considers comments by the public on proposed 
collections of information in--
    <bullet> Evaluating whether the proposed collections of information 
are necessary for the proper performance of the functions of the 
Department, including whether the information will have practical 
utility;
    <bullet> Evaluating the accuracy of the Department's estimate of 
the burden of the proposed collections of information, including the 
validity of the methodology and assumptions used;
    <bullet> Enhancing the quality, usefulness, and clarity of the 
information to be collected; and
    <bullet> Minimizing the burden of the collections of information on 
those who are to respond, including responses through the use of 
appropriate automated, electronic, mechanical, or other technological 
collection techniques or other forms of information technology, e.g., 
permitting electronic submission of responses.
    OMB is required to make a decision concerning the collection of 
information contained in this proposed rule between 30 and 60 days 
after publication of this document in the Federal Register. Therefore, 
a comment to OMB is best assured of having its full effect if OMB 
receives it within 30 days of publication. This does not affect the 
deadline for the public to comment on the proposed regulations.

Comment Period

    We are providing, except for comments on the information collection 
provisions, a comment period of 30 days for this proposed rule due to 
the December 1, 2001, effective date of the new benefit programs 
enacted by section 401 of Public Law 106-419, the statutory requirement 
for a final rule prior to that date, and the need to have a final rule 
as soon as possible in order to avoid delay in the commencement of 
those benefits. We are providing for the information collections in 
this document a 60-day comment period pursuant to the Paperwork 
Reduction Act.

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 would 
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 would 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 recordkeeping requirements, Scholarships and fellowships, Travel 
and transportation expenses, Veterans.

    Approved: October 26, 2001.
Anthony J. Principi,
Secretary of Veterans Affairs.

    For the reasons set forth in the preamble, 38 CFR part 17 is 
proposed to be 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 Secs. 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 Secs. 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 defects means the same as defined at Sec. 3.815(c)(3) 
of this title and also includes complications or medical conditions 
that are associated with the covered birth defects 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,

[[Page 213]]

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 Secs. 17.900 through 
17.905:
    (1) The telephone number of the VHA Health Administration Center is 
(888) 820-1756;
    (2) The facsimile number of the VHA Health Administration Center is 
(303) 331-7807;
    (3) The hand-delivery address of the VHA Health Administration 
Center is 300 S. Jackson Street, Denver, CO 80209; and
    (4) The mailing address of the VHA 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 
80246-9027.

(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 Secs. 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 VHA Health 
Administration Center is required for the following services or 
benefits under Secs. 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 VHA 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 
VHA Health Administration Center within 72 hours of the emergency.

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


Sec. 17.903  Payment.

    (a)(1) Payment for services or benefits under Secs. 17.900 through 
17.905 will be determined utilizing the same payment methodologies as 
provided for under the 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 VHA Health Administration Center in writing

[[Page 214]]

(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 
Secs. 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 Secs. 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 Secs. 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). When a claim under the 
provisions of Secs. 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:
    (1) Name and address of recipient,
    (2) Description of services and/or supplies provided,
    (3) Dates of services or supplies provided,
    (4) Amount billed,
    (5) Determined allowable amount,
    (6) To whom payment, if any, was made, and
    (7) Reasons for denial (if applicable).

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


Sec. 17.904  Review and appeal process.

    For purposes of Secs. 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 VHA 
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 VHA Health Administration Center (Attention: 
Director) a request for review by the Director, VHA 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)


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 Secs. 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. 01-31674 Filed 12-31-01; 8:45 am]
BILLING CODE 8320-01-P


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