Federal Register / Vol. 67, No. 1 / Wednesday, January 2, 2002 / Proposed Rules 209

(h) Referrals. If a regional office is 

unclear in any case as to whether a 

condition is a covered birth defect, it 

may refer the issue to the Director of the 

Compensation and Pension Service for 

determination. 

(i) Effective dates. Except as provided 

in § 3.114(a) or paragraph (i)(1) or (2) of 

this section, VA will award the 

monetary allowance under subchapter II 

of 38 U.S.C. chapter 18, for an 

individual with disability resulting from 

one or more covered birth defects, based 

on an original claim, a claim reopened 

after final disallowance, or a claim for 

increase, as of the date VA received the 

claim (or the date of birth if the claim 

is received within one year of that date), 

the date entitlement arose, or December 

1, 2001, whichever is later. Subject to 

the condition that no benefits may be 

paid for any period prior to December 

1, 2001: 

(1) VA will increase benefits as of the 

earliest date the evidence establishes 

that the level of severity increased, but 

only if the beneficiary applies for an 

increase within one year of that date. 

(2) If a claimant reopens a previously 

disallowed claim based on corrected 

military records, VA will award the 

benefit from the latest of the following 

dates: the date the veteran or beneficiary 

applied for a correction of the military 

records; the date the disallowed claim 

was filed; or, the date one year before 

the date of receipt of the reopened 

claim. 

(j) Reductions and discontinuances.

VA will generally reduce or discontinue 

awards under subchapter II of 38 U.S.C. 

chapter 18 according to the facts found 

except as provided in §§ 3.105 and 

3.114(b). 

(1) If benefits were paid erroneously 

because of beneficiary error, VA will 

reduce or discontinue benefits as of the 

effective date of the erroneous award. 

(2) If benefits were paid erroneously 

because of administrative error, VA will 

reduce or discontinue benefits as of the 

date of last payment.

(Authority: 38 U.S.C. 501, 1811, 1812, 1813, 

1814, 1815, 1816, 1821, 1822, 1823, 1824, 

5101, 5110, 5111, 5112)

[FR Doc. 01–31673 Filed 12–31–01; 8:45 am] 

BILLING CODE 8320–01–P

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.

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 OGCRegulations@mail.va.gov.

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 

§§ 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 

210 Federal Register / Vol. 67, No. 1 / Wednesday, January 2, 2002 / Proposed Rules 

identification of covered birth defects 

are included in proposed § 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 § 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 

Federal Register / Vol. 67, No. 1 / Wednesday, January 2, 2002 / Proposed Rules 211

§§ 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 

OGCRegulations@mail.va.gov. 

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 × 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 × 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 

212 Federal Register / Vol. 67, No. 1 / Wednesday, January 2, 2002 / Proposed Rules 

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 § 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 × 20 minutes). 

The Department considers comments 

by the public on proposed collections of 

information in— 

• 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; 

• 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; 

• Enhancing the quality, usefulness, 

and clarity of the information to be 

collected; and 

• 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 § 17.900 

and §§ 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

§ 17.900 Definitions. 

For purposes of §§ 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 § 3.814(c)(2) or § 3.815(c)(2) of this 

title and for purposes of covered birth 

defects means the same as individual as 

defined at § 3.815(c)(2) of this title. 

Covered birth defects means the same 

as defined at § 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, 

Federal Register / Vol. 67, No. 1 / Wednesday, January 2, 2002 / Proposed Rules 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 healthrelated 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 

§ 3.814(c)(1) or § 3.815(c)(1) of this title 

and for purposes of covered birth 

defects means the same as defined at 

§ 3.815(c)(1) of this title.

(Authority: 38 U.S.C. 101(2), 1802–1803, 

1811–1813, 1821)

§ 17.901 Provision of health care. 

(a) Spina bifida. VA will provide a 

Vietnam veteran’s child who has been 

determined under § 3.814 or § 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 notfor-profit charitable entities. 

(b) Covered birth defects. VA will 

provide a woman Vietnam veteran’s 

child who has been determined under 

§ 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 § 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 §§ 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 § 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 §§ 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 thirdparty 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.

§ 17.902 Preauthorization. 

(a) Preauthorization from a benefits 

advisor of the VHA Health 

Administration Center is required for 

the following services or benefits under 

§§ 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)

§ 17.903 Payment. 

(a)(1) Payment for services or benefits 

under §§ 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 § 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 § 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 § 3.815 of this title. 

(3) Claims from approved health care 

providers must be filed with the VHA 

Health Administration Center in writing 

214 Federal Register / Vol. 67, No. 1 / Wednesday, January 2, 2002 / Proposed Rules 

(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 §§ 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 §§ 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 §§ 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 

§§ 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)

§ 17.904 Review and appeal process. 

For purposes of §§ 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 § 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)

§ 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 §§ 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