Compensation for Certain Undiagnosed Illnesses

DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 3

RIN 2900-AH35

Compensation for Certain Undiagnosed Illnesses

AGENCY: Department of Veterans Affairs.

ACTION: Proposed rule.

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SUMMARY: The Department of Veterans Affairs (VA) is proposing to amend

its adjudication regulations to authorize compensation for disabilities

resulting from the undiagnosed illnesses of Persian Gulf veterans. This

amendment would provide the necessary regulatory framework to allow the

Secretary to pay compensation under the authority granted by the

Persian Gulf War Veterans' Benefits Act.

DATES: Comments must be received on or before January 9, 1995.

ADDRESSES: Mail written comments to: Director, Office of Regulations

Management (02D), Department of Veterans Affairs, 810 Vermont Ave, NW.,

Washington, DC 20420, or hand-deliver written comments to: Office of

Regulations Management, Room 1176, 801 Eye Street, NW., Washington, DC

20001. Comments should indicate that they are in response to ``RIN

2900-AH35.'' All written comments received will be available for public

inspection in the Office of Regulations Management, Room 1176, 801 Eye

Street, NW., Washington, DC 20001, between the hours of 8:00 a.m. and

4:30 p.m., Monday through Friday (except holidays).

FOR FURTHER INFORMATION CONTACT: Steven Thornberry, Consultant,

Regulations Staff, Compensation and Pension Service, Veterans Benefits

Administration, 810 Vermont Avenue, NW., Washington, DC 20420,

telephone (202) 273-7210.

SUPPLEMENTARY INFORMATION: Following the return of U.S. forces from the

Persian Gulf region, some Persian Gulf War veterans began exhibiting

symptoms that could not be attributed to known clinical diagnoses. A

National Institutes of Health Technology Assessment Workshop on the

Persian Gulf experience and health, held from April 27-29, 1994, found

that many of these veterans presented combinations of nonspecific

symptoms of fatigue, skin rash, muscle and joint pain, headache, loss

of memory, shortness of breath, and gastrointestinal and respiratory

symptoms, which may not fit readily into a common diagnosis. The panel

reported that it was impossible to establish a single-case definition

of the illnesses suffered by these Persian Gulf veterans, and that, in

fact, a single case-definition might not be sufficient, since more than

one disease category might be present.

Section 1110 of title 38, United States Code, authorizes VA to

compensate for disabilities arising from personal disease or injury

incurred or aggravated in the line of duty during active military,

naval, or air service. However, since many of the symptoms reported by

Persian Gulf veterans cannot be attributed to a known disease or

injury, until now VA has had no authority to compensate for them.

In response to the needs and concerns of Persian Gulf veterans,

Congress enacted the ``Persian Gulf War Veterans' Benefits Act,'' Title

I of the ``Veterans' Benefits Improvements Act of 1994,'' Public Law

103-446. That statute added a new section 1117 to title 38, United

States Code, authorizing the Secretary of Veterans Affairs to

compensate any Persian Gulf veteran suffering from a chronic disability

resulting from an undiagnosed illness or combination of undiagnosed

illnesses that became manifest either during active duty in the

Southwest Asia theater of operations during the Persian Gulf War or to

a degree of 10 percent or more within a presumptive period, as

determined by the Secretary, following service in the Southwest Asia

theater of operations during the Persian Gulf War. The statute directs

that VA's implementing regulations should address: (1) The nature,

period, and geographical areas of military service in connection with

which compensation may be paid; (2) the illnesses for which

compensation may be paid; and (3) any relevant medical characteristic

associated with each such illness. The statute further provides that a

disability for which compensation is payable under Sec. 1117 shall be

considered service connected for the purposes of all laws of the United

States.

To implement these provisions of Public Law 103-446, we propose to

amend title 38, Code of Federal Regulations, by adding a new

Sec. 3.317, to establish eligibility criteria for compensation for

Persian Gulf veterans with chronic disabilities resulting from an

undiagnosed illness or combination of undiagnosed illnesses. We propose

to require that veterans exhibit objective indications of chronic

disabilities resulting from these undiagnosed illnesses. ``Objective

indications'' means both ``signs,'' in the medical sense of objective

evidence perceptible to an examining physician, and other indicators

that are non-medical in nature but capable of independent verification.

Non-medical indicators include, but are not limited to, such

circumstances or events as time lost from work, evidence that a veteran

has sought medical treatment for his or her symptoms, and evidence

affirming such things as changes in the veteran's appearance, physical

abilities, and mental or emotional attitude. Lay statements from

knowledgeable individuals may be accepted as evidence providing

objective indications if they support the conclusion that a disability

exists. Objective indications will assist us in determining the actual

presence of a disability as well as the extent of impairment caused by

the disability.

Public Law 103-446 requires that our regulations contain a

description of the illnesses for which compensation may be paid.

Therefore, we are proposing that undiagnosed illnesses be manifested by

one or more signs or symptoms, 13 categories of which are specified in

the regulation. The categories listed represent the wide range of signs

and symptoms noted in the over 17,000 completed and analyzed

examinations of participants in VA's Persian Gulf Registry, including

those veterans for whom a known clinical diagnosis has not been

established. Since signs and symptoms not represented by one of the

listed categories could legitimately qualify for consideration under

Sec. 3.317, we propose to provide that the list of 13 illness

categories is not exclusive.

However, we propose to prohibit payment under Sec. 3.317 for

disabilities that, through medical history, physical examination, and

laboratory tests, are determined to result from any known clinical

diagnosis. Once such a diagnosis is established, the condition would

fall outside the scope of this rule, but would certainly receive

consideration for service connection under other sections of the

statute and regulations governing direct incurrence or aggravation of a

disease or injury during active duty or appearance of the condition

following active duty within established presumptive periods.

We are proposing to consider a disability chronic if it has existed

for 6 months or more. In our judgment, this is a reasonable period,

generally accepted within the medical community, for distinguishing

chronic disabilities from those that are acute. Disabilities which are

subject to intermittent episodes of improvement and worsening within a

6-month period would be considered chronic. However, acute and

transitory conditions would not be considered chronic. We further

propose to authorize VA rating boards to evaluate the level of

impairment of chronic disabilities resulting from undiagnosed illnesses

using criteria from the Schedule for Rating Disabilities (38 CFR, part

4) for a disease or injury in which the functions affected, the

anatomical localization, and symptomatology are similar. Because we

cannot predict the course of an undiagnosed illness, we intend to

monitor veterans who receive compensation under Sec. 3.317 and

reexamine them as necessary to ensure that appropriate levels of

compensation are being paid. It is anticipated that in most cases a

reexamination would occur at approximately 24 months after the initial

examination.

We are proposing to establish a 2-year presumptive period following

service in the Southwest Asia theater of operations during the Persian

Gulf War for the undiagnosed illnesses of Persian Gulf veterans. Public

Law 103-446 specifies that the Secretary shall establish a post-Gulf-

service presumptive period after reviewing any credible medical or

scientific evidence, the historical treatment afforded other diseases

for which service connection is presumed, and other pertinent

circumstances regarding the experiences of Persian Gulf veterans.

Congress has for many years authorized a one-year presumptive period

for various chronic diseases, including certain muscular, neurological,

digestive, and musculoskeletal diseases whose characteristic signs and

symptoms may include some of those which this rule would cover. Based

upon our experience with chronic diseases with similar signs and

symptoms, it is our view that most illnesses related to Persian Gulf

service would become manifest within one year after such service.

However, we know of no evidence to suggest that any undiagnosed

illnesses would take longer than 2 years to become manifest.

An additional reason for proposing a 2-year presumptive period,

rather than a one-year period, is that VA did not begin full-scale

operation of its Persian Gulf Registry until November 1992. Many

Persian Gulf veterans first presented their health concerns in

connection with a Registry examination that would not have been

available to them within one year after leaving the Persian Gulf

region. Within 2 years, however, all veterans of the hostilities in the

Persian Gulf would have had this opportunity to document their

illnesses.

Our proposed presumptive period for Persian Gulf veterans would be

measured from when they last performed duty in the Southwest Asia

theater of operations, rather than from the date of separation as in

prior presumptive periods authorized by Congress, for several reasons.

First, the language of Public Law 103-446 indicates that the

presumptive period will be so based. Second, because concerns relating

to Persian Gulf service gave rise to the legislation, it is only

reasonable that the presumptive period be measured from when such

service ended. Third, in other circumstances in which health concerns

have been determined to be related to possibly hazardous exposures

occurring during service, such as exposure to herbicides in Vietnam,

presumptive periods have been measured from the last date on which the

exposure could have occurred. Finally, because many Persian Gulf

veterans left active duty shortly after returning from the Persian Gulf

theater while others continued (and will continue) to serve on active

duty for many years, widely disparate treatment could result if the

presumptive period were measured from the date of a veteran's

separation from service.

Public Law 103-446 requires that our regulations contain a

description of the period and geographical area or areas of military

service in connection with which compensation under 38 U.S.C. Sec. 1117

may be paid. Therefore, we are proposing to extend eligibility for

consideration under Sec. 1117 to any veteran who served within the

Southwest Asia theater of operations during the Persian Gulf War, which

by statute extends from August 2, 1990, through a date yet to be

determined by law or Presidential proclamation (38 U.S.C.

Sec. 101(33)). At this time we have no information that indicates that

those serving in specific areas of the theater of operations have

greater risk of developing undiagnosed illnesses and, therefore,

believe it only appropriate that this provision apply to veterans who

served anywhere within that area.

We are proposing that compensation may not be paid under Sec. 3.317

in the following situations:

(1) If there is affirmative evidence that an undiagnosed illness

was not incurred during active military, naval, or air service in the

Southwest Asia theater of operations during the Persian Gulf War. This

is in keeping with Public Law 103-446, which specifies that

compensation may be paid for chronic disability resulting from

undiagnosed illnesses that became manifest during active duty in the

Persian Gulf area during the Persian Gulf War.

(2) If there is affirmative evidence that an undiagnosed illness

was caused by a supervening condition or event that occurred between

the veteran's most recent departure from active duty in the Southwest

Asia theater of operations during the Persian Gulf War and the onset of

the illness. This follows the statutory requirement of 38 U.S.C.

Sec. 1113(a), as amended by Public Law 103-446. In such a situation, if

it is clear that an undiagnosed illness is due to an intervening cause,

it would be inappropriate to presume that it is related to Persian Gulf

service. This provision is consistent with similar provisions applying

to other presumptive conditions, such as those related to exposure to

ionizing radiation, herbicides used in Vietnam, mustard gas, and to the

prisoner-of-war experience.

(3) If there is affirmative evidence that the illness is the result

of the veteran's own willful misconduct or the abuse of alcohol or

drugs. This follows the statutory requirements in 38 U.S.C.

Secs. 105(a), 1110, 1113, and 1131.

We propose to define Southwest Asia theater of operations to

include Iraq, Kuwait, Saudi Arabia, the neutral zone between Iraq and

Saudi Arabia, Bahrain, Qatar, the United Arab Emirates, Oman, the Gulf

of Aden, the Gulf of Oman, the Persian Gulf, the Arabian Sea, the Red

Sea, and the airspace above these locations. This definition follows

Executive Order 12744 of January 21, 1991, in which President Bush

designated the combat zone of the Persian Gulf War.

Situations may arise that will require termination or reduction of

payments previously awarded under Sec. 3.317, for example,

establishment of a known clinical diagnosis as the cause of a veteran's

disabilities. We therefore propose to amend Sec. 3.500 to add a

paragraph providing that reduction or termination of benefits would be

effective the last day of the month in which the 60-day period

following notice to the payee of VA's final rating action expires.

Final rating action would not be taken prior to expiration of a 60-day

predetermination period, during which the payee would have an

opportunity to show why benefits should not be reduced or terminated.

These procedures follow the regulatory requirements in 38 CFR 3.103(b),

which requires a 60-day predetermination period in actions involving

adverse determinations; and in 38 CFR 3.105 (d) and (e), which, where

reduction or severance of service-connected compensation is involved,

require termination no earlier than the last day of the month in which

a 60-day period following notice to the beneficiary of the final rating

action expires. It is reasonable and consistent with VA policy to adopt

the same procedures in regard to benefits payable under Sec. 3.317.

Termination or reduction of benefits paid under Sec. 3.317 would not

preclude continuation of payments if entitlement is established under

other sections of the statute or regulations governing grants of

service connection for diseases or injuries that are incurred or

aggravated during active duty or that first appear after active duty

but within a statutory or regulatory presumptive period.

We are proposing to make these amendments effective November 2,

1994, the effective date of Title I of Public Law 103-446. The comment

period has been shortened from 60 days to 30 days. The 30-day period

would appear to provide adequate time for the submission of comments on

this proposed rulemaking. The shortened comment period would also

expedite establishment of a final rule and thereby allow for quicker

payment of compensation to eligible individuals.

The Secretary hereby certifies that this regulatory amendment will

not have a significant economic impact on a substantial number of small

entities as they are defined in the Regulatory Flexibility Act (RFA), 5

U.S.C. 601-612. The reason for this certification is that this

amendment would not directly affect small entities. Only VA

beneficiaries could be directly affected. Therefore, pursuant to 5

U.S.C. 605(b), this amendment is exempt from the initial and final

regulatory flexibility analysis requirements of Secs. 603 and 604.

This regulatory amendment has been reviewed by the Office of

Management and Budget under the provisions of Executive Order 12866,

Regulatory Planning and Review, dated September 30, 1993.

The Catalog of Federal Domestic Assistance program numbers are

64.109 and 64.110.

List of Subjects in 38 CFR Part 3

Administrative practice and procedure, Claims, Health care,

Individuals with disabilities, Pensions, Veterans.

Approved: December 2, 1994.

Jesse Brown,

Secretary of Veterans Affairs.

For the reasons set forth in the preamble, 38 CFR Part 3 is

proposed to be amended as follows:

PART 3--ADJUDICATION

Subpart A--Pension, Compensation, and Dependency and Indemnity

Compensation

1. The authority citation for part 3, subpart A continues to read

as follows:

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

2. Section 3.317 is added to read as follows:

Sec. 3.317 Compensation for certain disabilities due to undiagnosed

illnesses.

(a)(1) Except as provided in paragraph (c) of this section, VA

shall pay compensation in accordance with chapter 11 of title 38,

United States Code, to a Persian Gulf veteran who exhibits objective

indications of chronic disability resulting from an illness or

combination of illnesses manifested by one or more signs and symptoms

such as those listed in paragraph (b) of this section, provided that

such disability:

(i) Became manifest either during active military, naval, or air

service in the Southwest Asia theater of operations during the Persian

Gulf War, or to a degree of 10 percent or more not later than two years

after the date on which the veteran last performed active military,

naval, or air service in the Southwest Asia theater of operations

during the Persian Gulf War; and

(ii) By history, physical examination, and laboratory tests cannot

be attributed to any known clinical diagnosis.

(2) A disability referred to in this section will be considered

chronic if it has existed for 6 months or more.

(3) The chronic disability resulting from an illness referred to in

this section shall be rated using evaluation criteria from part 4 of

this chapter for a disease or injury in which the functions affected,

anatomical localization, and symptomatology are similar.

(4) A disability referred to in this section shall be considered

service connected for purposes of all laws of the United States.

(b) For the purposes of paragraph (a)(1) of this section, signs or

symptoms which may be manifestations of undiagnosed illness include,

but are not limited to:

(1) Fatigue

(2) Signs or symptoms involving skin

(3) Headache

(4) Muscle pain

(5) Joint pain

(6) Neurologic signs or symptoms

(7) Neuropsychological signs or symptoms

(8) Signs or symptoms involving the respiratory system (upper or

lower)

(9) Sleep disturbances

(10) Gastrointestinal signs or symptoms

(11) Cardiovascular signs or symptoms

(12) Abnormal weight loss

(13) Menstrual disorders.

(c) Compensation shall not be paid under this section:

(1) If there is affirmative evidence that an undiagnosed illness

was not incurred during active military, naval, or air service in the

Southwest Asia theater of operations during the Persian Gulf War; or

(2) If there is affirmative evidence that an undiagnosed illness

was caused by a supervening condition or event that occurred between

the veteran's most recent departure from active duty in the Southwest

Asia theater of operations during the Persian Gulf War and the onset of

the illness; or

(3) If there is affirmative evidence that the illness is the result

of the veteran's own willful misconduct or the abuse of alcohol or

drugs.

(d) For purposes of this section:

(1) The term ``Persian Gulf veteran'' means a veteran who served on

active military, naval, or air service in the Southwest Asia theater of

operations during the Persian Gulf War.

(2) The Southwest Asia theater of operations includes Iraq, Kuwait,

Saudi Arabia, the neutral zone between Iraq and Saudi Arabia, Bahrain,

Qatar, the United Arab Emirates, Oman, the Gulf of Aden, the Gulf of

Oman, the Persian Gulf, the Arabian Sea, the Red Sea, and the airspace

above these locations.

(Authority: Title I, Pub. L. 103-446; 38 U.S.C. 501(a))

3. Section 3.500 is amended by adding paragraph (y) to read as

follows:

Sec. 3.500 General.

* * * * *

(y) Compensation for certain disabilities due to undiagnosed

illnesses (Secs. 3.317 and 3.105). Last day of the month in which the

60-day period following notice to the payee of the final rating action

expires. This applies to both reduced evaluations and severance of

service connection.

(Authority: Public Law 103-446; 38 U.S.C. 501(a))

[FR Doc. 94-30133 Filed 12-7-94; 8:45 am]

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