Revised Criteria for Monetary Allowance for an Individual Born With Spina Bifida Whose Biological Father or Mother is a Vietnam Veteran

AGENCY:

Department of Veterans Affairs.

ACTION:

Proposed rule.

SUMMARY:

This document proposes to amend the evaluation criteria that the Department of Veterans Affairs (VA) uses to determine the amount of the monthly monetary allowance that it pays to an individual born with spina bifida whose biological father or mother is a Vietnam veteran. The intended effect of this proposed amendment is to clarify the criteria to ensure that they are applied consistently and to add a provision allowing the Director of the Compensation and Pension Service to adjust the payment level for individuals with disabling impairments due to spina bifida that are not addressed in the evaluation criteria.

DATES:

Comments must be received on or before May 12, 2000.

ADDRESSES:

Mail or hand-deliver written comments to: Director, Office of Regulations Management (02D), Department of Veterans Affairs, 810 Vermont Ave., NW, Room 1154, 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 in response to “RIN 2900-AJ51.” All comments received will be available for public inspection at the above address in the Office of Regulations Management, Room 1158, between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday (except holidays).

FOR FURTHER INFORMATION CONTACT:

Caroll McBrine, M.D., Consultant, Policy and Regulations Staff (211B), Compensation and Pension Service, Veterans Benefits Administration, Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (202) 273-7230.

SUPPLEMENTARY INFORMATION:

Section 421 of Public Law 104-204 authorized VA to provide certain benefits, including a monthly monetary allowance, to children suffering from spina bifida who are the natural children of Vietnam veterans. To implement the provisions of section 421, VA published final regulations, codified at 38 CFR 3.814, in the Federal Register on September 30, 1997 (62 FR 51274-281).

38 CFR 3.814(d) provides evaluation criteria for determining which of three levels of monthly monetary allowance an eligible individual will receive for disability due to spina bifida. The evaluation criteria are based not only on the presence of medical impairments due to spina bifida, but also on the disabling effects of those impairments on ordinary day-to-day activities, including activities outside the home, such as holding a job, attending school, traveling, etc. The disabling effects vary significantly from person to person depending on the basic severity of the impairment itself and the extent to which the effects of the impairment can be modified or controlled through mechanical means, medication, surgery, etc. In January 1998, VA reviewed a sample of adjudicated spina bifida claims and, based on actual medical evidence used to adjudicate these claims, assessed the effectiveness of the evaluation criteria and the manner in which they were applied. Based on that assessment, a further review of the medical literature, and suggestions from several service organizations, we propose to amend the evaluation criteria as discussed below.

Under current criteria, the effects of lower extremity impairment are evaluated as follows: Level I (the least severe level) if the child is “able to walk without braces or other external support (although gait may be impaired)”; Level II if the child is “ambulatory, but only with braces or other external support”; and Level III if the child is “unable to ambulate.” We found from our review that rating specialists applied the criteria inconsistently to individuals who occasionally use braces or a wheelchair, or who use them only outside the home. We propose to clarify the criteria so that the assessment is based on whichever mode of ambulation represents the individual's primary means of mobility in the community. Although some individuals may be able to move about their homes without braces or wheelchairs, in our view their primary means of mobility outside of the home is the best indicator of the extent to which their ability to engage in ordinary day-to-day activities is impaired. Furthermore, the change would assure that there is a clearly defined and uniform basis for assessing the effects of lower extremity impairment.

The effects of bowel and bladder impairment are currently evaluated as follows: Level I if the child “is continent of urine and feces”; Level II if the child “requires drugs or intermittent catheterization or other mechanical means to maintain proper urinary bladder function, or mechanisms for proper bowel function”; and Level III if the child “has complete urinary or fecal incontinence.” In reviewing adjudicated claims, we noted that the terms “proper urinary bladder function” and “proper bowel function” were interpreted differently by different raters. While many individuals with spina bifida do not have normal bowel or bladder function, neither are they completely incontinent of bowel or bladder. We propose to revise the criteria for evaluating the effects of bowel and bladder impairment to more clearly define the three levels and ensure that the criteria are consistently applied.

We propose to evaluate the extent to which bladder impairment affects the ability of the individual to engage in ordinary day-to-day activities based on the length of time the individual is usually able to remain dry during waking hours, and whether or not the individual requires the use of medication or some other means to achieve that level of control. Specifically, we propose to pay an individual who requires medication or other means to control the effects of urinary bladder impairment, and who, no more than two times per week, is unable to remain dry for at least three hours at a time during waking hours at Level II, and an individual who, despite the use of medication or other means to control the effects of urinary bladder impairment, at least three times per week is unable to remain dry for three hours at a time during waking hours at Level III.

The length of time that an individual is able to remain dry is an objective measure of the extent to which his or her ability to engage in ordinary day-to-day activities, such as working or attending school, is limited. Predictable three-hour intervals during waking hours that the individual can rely on remaining dry represent reasonable periods around which an individual can plan to conduct activities such as working, or attending school or social events, etc. At least one major study used a three-hour period in assessing whether conservative therapy could lessen or control incontinence (“The Chances of a Spina Bifida Patient Becoming Continent/Socially Dry By Conservative Therapy” (M. Knoll and H Madersbacher, Paraplegia, 1993, Jan; 31 (1): 22-27)). We propose to specify the frequency of inability to remain dry for at least three hours at a time during waking hours—no more than two times per week for Level II, and at least three times per week for Level III—to take into account the fact that individuals who are ordinarily able to remain dry for three hours may occasionally have an accidental involuntary release of urine due to reasons such as an acute illness, miscalculations in controlling fluid intake, etc. Basing evaluations on the frequency of inability to remain dry for at least three hours at a time during waking hours will assure that individuals with bladder impairment are consistently evaluated.

One service organization recommended that we evaluate impairment of bowel and bladder function based on whether the individual has voluntary control of those functions. This organization suggested that doing otherwise punishes children with spina bifida for receiving appropriate treatment and rehabilitation because they are still, in fact, incontinent. Rather than punishing individuals who are able to alleviate urinary incontinence by treatment, the criteria recognize that the ability to alleviate incontinence improves the individual’s ability to engage in ordinary day-to-day activities. Thus, we do not propose to adopt this recommendation.

The same organization pointed out that procedures necessary to treat or compensate for loss of voluntary control are intrusive, unpleasant, and time consuming. Although we will continue to evaluate the disabling effects of bowel or bladder impairment by evaluating the ability of an individual to engage in ordinary day-to-day activities, we will provide for special review consideration where treatment procedures for spina bifida result in disability of equivalent severity to the effects specified under Levels II and III.

The same organization has recommended that we use the results of cystometry with urodynamic testing, a method of directly measuring certain bladder functions, such as muscle tone and bladder capacity, when evaluating bladder impairment. The main value of urodynamic testing is to determine the most appropriate treatment and to evaluate the effectiveness of the treatment. Urodynamic testing does not address the individual's ability to engage in ordinary day-to-day activities, which is the basis of the evaluation criteria. Furthermore, requiring claimants to undergo these additional tests if they are not available from their private medical records would be unnecessarily intrusive and would not add to the evaluation process. Accordingly, we do not propose to incorporate urodynamic testing into the criteria.

The effects of bowel impairment may include difficulty emptying the bowel, fecal leakage, or both. We propose to evaluate the effects of bowel impairment based on the extent and frequency of fecal leakage and the degree to which the individual is able to control or modify the effects of impairment through bowel management techniques or other treatment (which would include suppositories, enemas, medication, biofeedback, behavior modification, diet, manual evacuation, etc.). We propose to determine the severity of fecal leakage based partly on whether or not the individual must wear absorbent materials on a daily basis. We propose that an individual who requires bowel management techniques or other treatment to control the effects of bowel impairment, but has only occasional or minimal fecal leakage, and does not need to wear absorbent materials every day, be evaluated at Level II. On the other hand, we propose that an individual who, despite the use of bowel management techniques or other treatment to control the effects of bowel impairment, has fecal leakage of such severity or frequency that he or she must wear absorbent materials every day, be evaluated at Level III. We also propose that an individual who regularly requires manual evacuation or digital stimulation to empty the bowel be evaluated at Level III, since these procedures may significantly interfere with ordinary day-to-day activities. We propose to substitute these criteria for the current requirement at Level III that there be “complete fecal incontinence.” The proposed criteria would take into account the extent to which fecal leakage limits the individual's ability to engage in ordinary day-to-day activities, and would enable raters to consistently and objectively evaluate individuals who, although neither totally continent nor incontinent, have partial control of the effects of bowel or bladder impairment.

One organization has stated that, under VA's Schedule for Rating Disabilities, evaluations of disability of the bowel or bladder are based on the actual loss of function and control without regard to the use of auxiliary means and that it is self-evident that VA should use the same criteria for individuals with spina bifida to avoid rating inconsistencies. Section 1155 of title 38, United States Code, the statutory authority for VA's Schedule for Rating Disabilities, provides that evaluations of disabled veterans be based, as far as practicable, upon average impairment of earning capacity, and be at one of ten grades in 10 percent increments. Section 1805(b) of title 38, United States Code, on the other hand, authorizes VA to pay a monetary allowance to an eligible child with spina bifida at one of three levels based on the degree of disability as determined in accordance with a schedule for rating such disabilities “to be prescribed by the Secretary.” By codifying the requirement elsewhere than 38 U.S.C. 1155, by requiring evaluations at three levels rather than 10, and by not directing that evaluations be based on average impairment of earning capacity or be expressed in percentages, we believe that Congress expected that we would not use the rating schedule for evaluating disabilities resulting from spina bifida.

At the urging of a number of service organizations, we considered using neurocognitive testing in lieu of standard IQ testing to measure the effects of intellectual impairment. However, we found no medical literature describing or assessing a standard method of neurocognitive screening to assess the effects of spina bifida. Major studies of disability due to spina bifida, such as “Disability in Children with Myelomeningocele” (J.H. Hagelsteen, J. Lagergren, H.R. Lie, F. Rasmussen, M.C. Borjeson, B. Lagerkvist, M. Muttilainen, K. Taudorf, and L. Kohler, Acta Paediatrica Scandinavica, 1989, 78 (5): 721-7), “Long-term Outcome in Surgically Treated Spina Bifida Cystica”; (Isao Date, M.D., Yasunori Yagyu, M.D., Shoji Asari, M.D., and Takshi Ohmoto, M.D., Surg. Neurol. 1993, 40:471-5), and “Open spina bifida: a complete cohort reviewed 25 years after closure” (Urology Department, Addenbrooke's Hospital, Cambridge, UK Dev Med Child Neurol 1995 Jan;37(1):19-29) used IQ test results to measure intellectual impairment. These documents did not mention neurocognitive testing. Furthermore, neurocognitive testing is a complex and time-consuming process, involves many testing variables, and is neither as widely available nor as standardized as IQ testing. Therefore, in our judgment, it is not feasible to use neurocognitive testing to measure the effects of intellectual impairment due to spina bifida.

A number of sources have suggested that verbal and performance IQ subscores are a better measure of impaired intellect than the overall IQ score, but offered no evidence to support that contention. The three studies referred to above relied on the overall IQ score rather than the subscores to measure intellectual impairment in individuals with spina bifida. We conducted a further search of the medical literature, but found no evidence that IQ subscores are a better measure of intellectual impairment than the overall IQ score. We therefore propose to continue using overall IQ scores to evaluate intellectual impairment.

Although the evaluation criteria are based on the disabling effects of the most common, indeed nearly universal, medical impairments that result from spina bifida, individuals may have other disabilities that result from spina bifida. Several organizations have expressed concern that individuals with conditions such as blindness or seizures resulting from spina bifida might be underpaid under the current criteria. We therefore propose to allow the Director of the Compensation and Pension Service to increase the payment level of an individual who would otherwise be paid at Level I or II and has one or more disabilities, such as blindness, uncontrolled seizures, or renal failure that result either from spina bifida or from treatment procedures for spina bifida, to the level that, in his or her judgment, best represents the extent to which the disabilities limit the individual's ability to engage in ordinary day-to-day activities, including activities outside the home. This provision would allow the Director to award an increase in the level of payment to Level II or Level III for any type of disability resulting from spina bifida or treatment procedures for spina bifida, if the effects of a disability are of equivalent severity to the effects specified under Level II or III. Therefore, should the results of neurocognitive testing or other special examinations, for example, be submitted, they could be considered, along with all other medical information, in determining whether the level of payment should be increased.

Since only a very limited number of individuals are eligible for the monthly monetary allowance for spina bifida, reserving the authority to increase payments based on disabilities not addressed in the evaluation criteria to the Director of the Compensation and Pension Service is feasible. Further, this procedure will assure that the Compensation and Pension Service is aware of any conditions occurring frequently enough to warrant further revisions of the criteria.

Although the current regulation uses the terms “child” and “children,” many of those entitled to this benefit are now adolescents or adults. Therefore, we propose to change the words “child” or “children” to “individual” or “individuals” throughout § 3.814. We also propose to define the term “individual” in § 3.814(c)(2). This definition will make it clear that this regulation applies to eligible individuals regardless of age.

We also propose to amend the regulations to provide that, when VA is required to reassess an individual's level of disability for purposes of the monetary allowance, VA will pay the individual at Level I in the absence of evidence adequate to support a higher level of disability or if the individual fails to report, “without good cause” for a scheduled examination, and to provide examples of good cause. This provision is similar to 38 CFR 3.655(a), “Failure to report for Department of Veterans Affairs examination,” as applied to other VA claimants.

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. This amendment would not directly affect any small entities. Only individuals 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 sections 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 64.104 and 64.109.

List of Subjects in 38 CFR Part 3

• Administrative practice and procedure
• Claims
• Disability benefits
• Health care
• Pensions
• Radioactive materials
• Veterans
• Vietnam

For the reasons set out in the preamble, 38 CFR part 3 is proposed to be amended as set forth below:

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. In § 3.814, the heading for the section and paragraphs (a), (c)(2), and (d) are revised to read as follows: