[Federal Register Volume 62, Number 189 (Tuesday, September 30, 1997)]
[Rules and Regulations]
[Pages 51281-51286]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25664]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AI65


Provision of Health Care to Vietnam Veterans' Children With Spina 
Bifida

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

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SUMMARY: This document establishes regulations regarding Vietnam 
veterans' children with spina bifida. The regulations concern the 
provision of health care needed for the spina bifida or any disability 
that is associated with such condition. This action is necessary to 
establish a mechanism for providing health care to such children in 
accordance with recently enacted legislation.

DATES: Effective Date: October 1, 1997.

FOR FURTHER INFORMATION CONTACT: Robert De Vesty, Health Systems 
Specialist, Office of Public Health and Environmental Hazards (13), 
Department of Veterans Affairs, 810 Vermont Avenue, NW, Washington DC, 
20420, telephone (202) 273-8575.

SUPPLEMENTARY INFORMATION: In a document published in the Federal 
Register on May 1, 1997 (62 FR 23731), we proposed to amend the 
``Medical'' regulations (38 CFR part 17) by setting forth new 
Secs. 17.900-17.905 regarding the provision of health care to Vietnam 
veterans' children with spina bifida. Spina bifida is a congenital 
birth defect, characterized by defective closure of the bones 
surrounding the spinal cord. The spinal cord and its covering (the 
meninges) may protrude through the defect.
    The provisions of 38 U.S.C. Chapter 18 (Pub. L. 104-204, section 
421, September 26, 1996) provide for three separate types of benefits 
for Vietnam veterans' children who suffer from spina bifida: (1) 
Monthly monetary allowances, (2) provision of health care needed for 
the spina bifida or any disability that is associated with such 
condition, and (3) provision of vocational training and rehabilitation.
    This document establishes a final rule to set forth a mechanism 
regarding provision of health care to Vietnam veterans' children with 
spina bifida.
    We requested that comments to the proposed rule be submitted on or 
before June 30, 1997. We received 33 comments. Based on the rationale 
set forth in the proposed rule and this document, the proposed rule is 
adopted as a final rule with changes explained below.

[[Page 51282]]

    Comments regarding issues concerning monthly monetary allowances 
for Vietnam veterans' children who suffer from spina bifida and the 
provision of vocational training and rehabilitation for such children 
will be addressed in separate final rules that specifically concern 
these issues.
    Some of the suggested changes cannot be made because they would be 
inconsistent with statutory authorities. There is no authority for VA 
to pay for services provided before October 1, 1997, or to pay for 
services prior to the date of receipt of application. There is no 
authority to provide comprehensive health care coverage or insurance 
(health care is limited to care for spina bifida or disabilities 
associated with such condition). There is no authority to provide such 
health care unless the child is a child of a Vietnam veteran who was 
not dishonorably discharged (see Pub. L. 104-204, 38 U.S.C. 101, 1801-
1806).
    Commenters asserted that the final rule should state specifically 
that the provision of health care would cover durable medical equipment 
and medical supplies, including catheters, diapers, pads, etc. Because 
this appeared to be a concern from many of the commenters, the final 
rule is clarified, consistent with the intent of the proposed rule, to 
state specifically that these types of equipment and supplies are 
covered when provided by VA or authorized by an approved health care 
provider (see Sec. 17.900(b) and the definition of ``health care'' in 
Sec. 17.901).
    One commenter questioned what standard would apply for replacing 
durable medical equipment, particularly when a child has outgrown 
medical equipment. In this regard, the provisions of Sec. 17.902 
provide that medical equipment will be covered based on a demonstrated 
medical need.
    Commenters questioned whether the final rule would cover adaptive 
housing and vehicles. VA is authorized to provide health care 
determined to be medically necessary. In our view, coverage for 
adaptive housing and vehicles is outside the scope of this 
authorization.
    One commenter questioned whether treatment of behavioral problems 
such as attention deficit disorder would be covered under the final 
rule. This would have to be determined on a case-by-case basis. Any 
health care determined to be needed for the spina bifida or any 
disability that is associated with such condition would be covered.
    One commenter questioned whether payment would be made for services 
if the child suffering from spina bifida has died. Covered services 
provided for an eligible child prior to death would be paid even if the 
child died after the services were provided.
    One commenter questioned whether complications during pregnancy of 
a Vietnam veterans' child who suffer from spina bifida would be 
covered. Another commenter questioned whether hydrocephalus and Arnold-
Chiari malformation would be covered for such children. Another 
questioned whether other abnormalities would be covered. These 
conditions would be covered insofar as they constitute a disability 
associated with spina bifida.
    One commenter questioned whether care at the Department of Defense 
(DOD) facilities would be paid by VA. Costs for care provided by DOD is 
the responsibility of DOD.
    One commenter asserted that preventive care should be listed 
specifically as a covered benefit. No changes are made based on this 
comment. The definition of ``health care'' in Sec. 17.901 specifically 
states that ``preventive care'' is covered.
    One commenter asserted that payment should be made for experimental 
or investigative care. No changes are made based on this comment. We 
have no way to determine whether such care would be effective and not 
harmful.
    Commenters asserted that payment for respite care and home care 
(including attendant care) and case management services should not be 
limited to approved health care providers and should include health 
care providers that are not certified or licensed. The terms ``health 
care provider'' and ``approved health care provider'' are defined in 
Sec. 17.901. No changes are made based on these comments. This final 
rule does not preclude services from individuals who do not qualify as 
``approved health care providers.'' However, VA will pay only for 
services rendered by ``approved health care providers.'' We believe 
that the utilization of approved health care providers as defined in 
Sec. 17.901 is necessary to ensure appropriate quality standards for 
services paid by VA.
    A number of commenters expressed concern that their ability to 
utilize Medicaid, Medicare, or other health insurance would be limited 
by the spina bifida program. In this regard, the spina bifida 
regulations provide for VA to be the exclusive payer only for services 
paid under the spina bifida regulations. Also, by statute monetary 
benefits are not considered income or resources in determining 
eligibility for or the amount of benefits under any Federal or 
Federally-assisted program, including Medicaid and Medicare. Consistent 
with these concepts, we added language to the final rule to state that 
in the usual case claims for health care for other than covered 
services for spina bifida and disabilities associated with spina bifida 
would be submitted to an insurer, Medicare, Medicaid, health plan, or 
other program providing health care coverage.
    One commenter expressed concern that charges could exceed the 
amount reimbursed by VA and that providers would charge patients for 
the excess. In this regard, the regulations state that VA is the 
exclusive payer for services paid under the spina bifida regulations. 
Accordingly, the amount paid by VA would constitute payment in full.
    Several commenters questioned whether they could have a choice 
regarding their provider. Recipients will be able to choose any 
provider meeting the criteria in Sec. 17.901.
    One commenter suggested that the preauthorization procedures are 
unnecessarily restrictive and burdensome, and that there should be an 
emergency exception for preauthorization. The preauthorization 
procedures apply to that type of care most likely to cause disagreement 
with respect to medical need. These procedures will help avoid 
unexpected liabilities for noncovered services. Further, it would be 
rare that an emergency would arise for the types of care requiring 
preauthorization. Even so, we have added provisions stating that 
preauthorization would not be required for a condition for which 
failure to receive immediate treatment poses a serious threat to life 
or health. A provision also is added stating that such emergency care 
should be reported by telephone within 72 hours of the emergency. These 
provisions would ensure that preauthorization procedures would not 
impede the provisions of emergent health care and would help ensure 
that recipients understand in a timely manner what health care is 
covered under this final rule.
    The preauthorization provisions state that care will be authorized 
only in those cases where there is a demonstrated medical need. One 
commenter asserted that the burden of proof should rest on VA regarding 
whether care is medically necessary. No changes are made based on this 
comment. The statutory provisions of 38 U.S.C. 1803(a) state that the 
Secretary shall provide ``such health care as the Secretary determines 
is needed for the child for the spina bifida or any disability 
associated with such condition.'' Even so, VA will consider any 
evidence from providers or others that might support a claim.

[[Page 51283]]

    One commenter asserted that Vietnam veterans' children who suffer 
from spina bifida should have the same appeal rights as other VA 
claimants. In this regard, Sec. 17.904 sets forth an appeal process and 
the note to this section states that there are further appellate rights 
for an appeal to the Board of Veterans' Appeals. This is equivalent to 
the appellate process afforded veterans for other matters.
    The proposed regulations provided that ``if a health care provider, 
Vietnam veteran's child or representative disagrees with a 
determination concerning provision of health care or a health care 
provider disagrees with a determination concerning payment, the person 
or entity may request reconsideration.'' The proposed regulations 
further provided that ``such request must be submitted in writing 
within one year of the date of the initial determination to the Chief, 
Administrative Division, Health Administration Center, P.O. Box 65025, 
Denver, CO 80206-9025.'' Moreover, the proposed regulations provided 
that ``if the person or entity seeking reconsideration is still 
dissatisfied, within 30 days of the date of the decision he or she may 
make a written request for review by the Director, Health 
Administration Center, P.O. Box 65025, Denver, CO 80206-9025.'' 
Commenters asserted that the 30-day period for further reconsideration 
should be extended to 90 or 180 days. In this regard, they argued that 
30 days might not be enough time for individuals on travel or who get 
their mail irregularly. The final rule extends the time period from 30 
days to 90 days. This should be adequate to allow sufficient time for 
the preparation of an appeal.
    One commenter asserted that the date for satisfying the period for 
filing an appeal be the date the appeal is postmarked. The provisions 
of Sec. 17.904 are amended to state that an appeal would be filed at 
the time it was delivered to VA or the time it was released for 
submission to VA (postmark would constitute evidence of release for 
submission to VA).
    One commenter asserted that the review appeal decisions should be 
required to include a statement of findings and reasons. The 
regulations are clarified to specifically require inclusion of findings 
and reasons.
    One commenter asserted that ID cards should be issued so that 
children suffering from spina bifida could more easily identify 
themselves to health care providers as eligible for benefits under the 
VA's spina bifida regulations. It is anticipated that ID cards will be 
issued.
    One commenter requested that the comment period for this rule 
making proceeding be extended until the end of the comment period for 
the proposed rule regarding vocational training and rehabilitation for 
Vietnam veterans' children who suffer from spina bifida. Such an 
extension is unwarranted. An understanding of the issues in the rule 
making proceeding regarding vocational training and rehabilitation is 
not necessary to make informed comments regarding this rule making 
proceeding.
    Additional changes are made to the final rule for purposes of 
clarification.

Executive Order 12866

    This final rule has been reviewed by OMB under Executive Order 
12866.

Administrative Procedure Act

    There is good cause for making this final rule effective without 
regard to a 30 day delay. This final rule does not adversely affect 
anyone and the affected children need the benefits from the rule as 
soon as possible.

Paperwork Reduction Act

    Information collection and recordkeeping requirements associated 
with this final rule (38 CFR 17.902, 17.903, 17.904) have been approved 
by the Office of Management and Budget (OMB) under the provisions of 
the Paperwork Reduction Act (44 U.S.C. 3501-3520) and have been 
assigned OMB control number 2900-0577.
    The provisions of 38 CFR 17.902 will require individuals to submit 
to a preauthorization specialist of the Health Administration Center a 
preauthorization application for health care consisting of case 
management, durable medical equipment, home care, professional 
counseling, mental health services, respite care, 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 application will 
contain the child'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. Such 
information is necessary to make preauthorization determinations in 
accordance with Sec. 17.902.
    The provisions of 38 CFR 17.903 will require that, as a condition 
of payment, claims from ``approved health care providers'' for health 
care provided under 38 CFR 17.900 must include the following 
information, as appropriate: with respect to patient identification 
information: the veteran's and patient's full name, social security 
numbers, patient's address, and date of birth; with respect to patient 
treatment information (inpatient and outpatient services): full name 
and address (such as hospital or physician), remittance address, 
physical location 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 (SSN); with 
respect to patient treatment information (inpatient 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. 
Such information will be necessary to make payment determinations in 
accordance with 38 CFR 17.903.
    The provisions of 38 CFR 17.904 will 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 will be required to submit such request to the Chief, 
Administrative Division, Health Administration Center, 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 advisor will 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 will be 
permitted to make a written request for review by the

[[Page 51284]]

Director, Health Administration Center. The information to be collected 
under Sec. 17.904 is necessary to make review and appeal 
determinations.
    Interested parties were invited to submit comments on the 
collection of information. However, no comments were received.
    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. The valid OMB control number 
assigned to the collections of information in this final rule is 
displayed at the end of each of the affected sections of the 
regulations.

Regulatory Flexibility Act

    The Secretary hereby certifies that this final 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 between 600 and 2,000 Vietnam veterans' 
children who suffer from spina bifida. 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), the final rule is exempt from the initial and final 
regulatory flexibility analysis requirements of Secs. 603 and 604.
    There are no Catalog of Federal Domestic Assistance numbers for 
this final rule.

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: September 11, 1997.
Hershel W. Gober,
Acting 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, an undesignated center heading and new Secs. 17.900 
through 17.905 are added to read as follows:

Health Care for a Vietnam Veteran's Child With Spina Bifida

Sec.
17.900  Spina bifida--provision of health care.
17.901  Definitions.
17.902  Preauthorization.
17.903  Payment.
17.904  Review and appeal process.
17.905  Medical records.

Health Care for a Vietnam Veteran's Child With Spina Bifida


Sec. 17.900  Spina bifida--provision of health care.

    (a) VA shall provide a Vietnam veteran's child who has been 
determined under Sec. 3.814 of this title to suffer from spina bifida 
with such health care as the Secretary determines is needed by the 
child for the spina bifida or any disability that is associated with 
such condition. This is not intended to be a comprehensive insurance 
plan and does not cover health care unrelated to spina bifida.
    (b) Health care provided under this section shall be provided 
directly by VA, by contract with an approved health care provider, or 
by other arrangement with an approved health care provider. VA may 
inform spina bifida patients, parents, or guardians that health care 
may be available at not-for-profit charitable entities.

(Authority: 38 U.S.C. 101(2), 1801-1806)

    Note to Sec. 17.900: VA provides payment under this section only 
for health care relating to spina bifida or a disability that is 
associated with such condition. VA is the exclusive payer for 
services paid under this section 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 
and not constituting a disability that is associated with such 
condition (accordingly, in the usual case claims for health care for 
other than covered services for spina bifida and disabilities 
associated with spinal bifida would be submitted to an insurer, 
Medicare, Medicaid, health plan, or other program providing health 
care coverage).


Sec. 17.901  Definitions.

    For purposes of Secs. 17.900 through 17.905--
    Approved health care provider means a health care provider approved 
by the Health Care Financing Administration (HCFA), Department of 
Defense Civilian Health and Medical Program of the Uniformed Services 
(CHAMPUS), Civilian Health and Medical Program of the Department of 
Veterans Affairs (CHAMPVA), Joint Commission on Accreditation of Health 
Care Organizations (JCAHO), or any health care provider approved for 
providing health care pursuant to a state license or certificate. An 
entity or individual shall be deemed to be an approved health care 
provider only when acting within the scope of the approval, license, or 
certificate.
    Child means the same as defined at Sec. 3.814(c) of this title.
    Habilitative and rehabilitative care means such professional 
counseling, guidance services and treatment programs (other than 
vocational training under 38 U.S.C. 1804) 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 who furnishes 
health care, including specialized spina bifida 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 an 
individual in the individual's home or other place of residence.
    Hospital care means care and treatment furnished to an individual 
who has been admitted to a hospital as a patient.
    Nursing home care means care and treatment furnished to an 
individual who has been admitted to a nursing home as a resident.
    Outpatient care means care and treatment, including preventive 
health services, furnished to an individual other than hospital care or 
nursing home care.

[[Page 51285]]

    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 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 associated 
medical conditions which are adjunct to spina bifida according to the 
scientific literature).
    Vietnam veteran means the same as defined at Sec. 3.814(c) of this 
title.

(Authority: 38 U.S.C. 101(2), 1801-1806)


Sec. 17.902  Preauthorization.

    (a) Preauthorization from a preauthorization specialist of the 
Health Administration Center is required for health care consisting of 
case management, durable medical equipment, home care, professional 
counseling, mental health services, respite care, training, substance 
abuse treatment, dental services, transplantation services, or travel 
(other than mileage at the General Services Administration rate for 
privately owned automobiles). This care will be authorized only in 
those cases where there is a demonstrated medical need. Applications 
for provision of health care requiring preauthorization shall either be 
made by telephone at (800) 733-8387, or in writing to Health 
Administration Center, P.O. Box 65025, Denver, CO 80206-9025. The 
application shall 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 shall not be 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 at 
(800) 733-8387 to the Health Administration Center, Denver, CO within 
72 hours of the emergency.

(Paperwork requirements were approved by the Office of Management 
and Budget under control number 2900-0577.)

(Authority: 38 U.S.C. 101(2), 1801-1806)


Sec. 17.903  Payment.

    (a)(1) Payment under this section 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 38 CFR 17.84).
    (2) As a condition of payment, the services must have occurred 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. Also, as a condition of payment, claims from approved health 
care providers for health care provided under this section must be 
filed with the Health Administration Center, P.O. Box 65025, Denver, CO 
80206-9025, 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 authorization.
    (3) Claims for health care provided under the provisions of 
Secs. 17.900 through 17.905 shall contain, as appropriate, the 
information set forth in paragraphs (a)(3)(i) through (a)(3)(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) Drug Code for drug provided,
    (D) Strength,
    (E) Quantity,
    (F) Date dispensed,
    (G) Pharmacy receipt for each drug dispensed (including billed 
charge), and
    (H) Diagnosis.
    (b) Health care payment shall 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,

[[Page 51286]]

    (4) Amount billed,
    (5) Determined allowable amount,
    (6) To whom payment, if any, was made, and
    (7) Reasons for denial (if applicable).

(Paperwork requirements were approved by the Office of Management 
and Budget under control number 2900-0577.)

(Authority: 38 U.S.C. 101(2), 1801-1806)


Sec. 17.904  Review and appeal process.

    If a health care provider, Vietnam veteran's child or 
representative disagrees with a determination concerning provision of 
health care or a health care provider disagrees with a determination 
concerning payment, the person or entity may request reconsideration. 
Such request must be submitted in writing within one year of the date 
of the initial determination to the Chief, Administrative Division, 
Health Administration Center, P.O. Box 65025, Denver, CO 80206-9025. 
The request must state why it is concluded 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 make a written request for review by the Director, Health 
Administration Center, P.O. Box 65025, Denver, CO 80206-9025. 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 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.

(Paperwork requirements were approved by the Office of Management 
and Budget under control number 2900-0577.)

(Authority: 38 U.S.C. 101(2), 1801-1806)


Sec. 17.905  Medical records.

    Copies of medical records generated outside VA that relate to 
activities for which VA is asked to provide payment, and 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), 1801-1806)

[FR Doc. 97-25664 Filed 9-29-97; 8:45 am]
BILLING CODE 8320-01-P