[Federal Register Volume 67, Number 163 (Thursday, August 22, 2002)]
[Proposed Rules]
[Pages 54394-54397]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-21366]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 4

RIN 2900-AL26


Schedule for Rating Disabilities; Guidelines for Application of 
Evaluation Criteria for Certain Respiratory and Cardiovascular 
Conditions; Evaluation of Hypertension With Heart Disease

AGENCY: Department of Veterans Affairs.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: This document proposes to amend the Department of Veterans 
Affairs (VA) Schedule for Rating Disabilities, in order to provide 
guidance in the evaluation of certain respiratory and cardiovascular 
conditions, and to explain that hypertension will be evaluated 
separately from hypertensive and other types of heart diseases. The 
intended effect of this amendment is to clarify the use of the current 
criteria for evaluating respiratory and cardiovascular conditions, 
particularly in cases where alternative criteria are provided, in order 
to ensure that veterans receive consistent evaluations and are not 
required to undergo unnecessary tests.

DATES: Comments must be received on or before October 21, 2002.

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 [email protected]. 
Comments should indicate that they are submitted in response to ``RIN 
2900-AL26.'' 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).

FOR FURTHER INFORMATION CONTACT: Caroll McBrine, M.D., Consultant, 
Regulations Staff (211A), Compensation and Pension Service, Veterans 
Benefits Administration, Department of Veterans Affairs, 810 Vermont 
Ave., NW., Washington, DC 20420, (202) 273-7210.

SUPPLEMENTARY INFORMATION:

Evaluation of Certain Respiratory Conditions

    Since revised evaluation criteria for respiratory conditions were 
established in 1996, the evaluation of most respiratory conditions has 
been based primarily on the results of specific pulmonary function 
tests (PFT's). Conditions evaluated on that basis include chronic 
bronchitis (diagnostic code 6600), pulmonary emphysema (diagnostic code 
6603), chronic obstructive pulmonary disease (diagnostic code 6604), 
interstitial lung disease (diagnostic codes 6825-6833), and restrictive 
lung disease (diagnostic codes 6840-6845). In some cases, the rating 
schedule provides alternative evaluation criteria that may be used 
instead of PFT's. These include measures of the maximum exercise 
capacity; the presence of pulmonary hypertension (documented by 
echocardiogram or cardiac catheterization), cor pulmonale, or right 
ventricular hypertrophy; episode(s) of respiratory failure; and a 
requirement for outpatient oxygen therapy. Alternative criteria were 
established in order to provide more than one route to reach a 
particular level of evaluation and, at the same time, avoid requiring 
that veterans undergo additional invasive, risky, costly, or time-
consuming tests when one or more objective and reliable tests or 
findings suitable for evaluation purposes are already of record.
    Applying the PFT results can be difficult in some cases. We 
therefore propose to add provisions that would clarify the use of PFT's 
in evaluating respiratory conditions to 38 CFR 4.96 as paragraph (d), 
titled ``Special provisions for the application of evaluation criteria 
for diagnostic codes 6600, 6603, 6604, 6825-6833, and 6840-6845.'' We 
developed these provisions after consultation with the Pulmonary/
Critical Care Advisory Committee of the Veterans Health Administration.
    Chronic bronchitis (diagnostic code 6600) is an example of a 
respiratory condition that is evaluated primarily on the basis of PFT's 
but also has alternative evaluation criteria. The criteria for a 100-
percent evaluation are FEV-1 (Forced Expiratory Volume in one second) 
less than 40 percent of predicted value, the ratio of FEV-1 to FVC 
(Forced Vital Capacity) less than 40 percent, DLCO (SB) (Diffusion 
Capacity of the Lung for Carbon Monoxide by the Single Breath Method) 
less than 40-percent predicted, maximum exercise capacity less than 15 
ml/kg/min oxygen consumption (with cardiac or respiratory limitation), 
cor pulmonale (right heart failure), right ventricular hypertrophy, 
pulmonary hypertension (shown by echocardiogram or cardiac 
catheterization), episode(s) of acute respiratory failure, or a 
requirement for outpatient oxygen therapy. The criteria for a 60-
percent evaluation are FEV-1 of 40- to 55-percent predicted, FEV-1/FVC 
of 40 to 55 percent, DLCO (SB) of 40- to 55-percent predicted, or 
maximum oxygen consumption of 15 to 20 ml/kg/min (with 
cardiorespiratory limit). The criteria for a 30-percent evaluation are 
FEV-1 of 56- to 70-percent predicted, FEV-1/FVC of 56 to 70 percent, or 
DLCO (SB) 56- to 65-percent predicted. The criteria for a 10-percent 
evaluation are FEV-1 of 71- to 80-percent predicted, FEV-1/FVC of 71 to 
80 percent, or DLCO (SB) 66- to 80-percent predicted.
    For the first provision, we propose to state when pulmonary 
function testing is not needed for disability evaluation purposes. The 
first instance would be when there is a maximum exercise capacity of 
record that is 20 ml/kg/min or less (which would result in a 60- or 
100-percent evaluation). Although this test is not routinely done, and 
not all facilities have the necessary equipment to conduct the test, if 
available, it is a reliable and precise way to assess respiratory 
disability, so it may be used to evaluate when it is available and is 
reported at levels that would warrant a 60- or 100-percent evaluation. 
If not of record, however, evaluation will be based on alternative 
criteria. The second instance would be when pulmonary hypertension 
(documented by an echocardiogram or cardiac catheterization), cor 
pulmonale, or right ventricular hypertrophy has been diagnosed. Any of 
these would result in a 100-percent evaluation. The third instance 
would be when there is a history of one or more episodes of acute 
respiratory failure, and the fourth instance would be when there is a 
requirement for outpatient oxygen therapy, because either of these also 
establishes entitlement to a 100-percent evaluation.
    Routine pulmonary function testing may or may not include a 
measurement of DLCO (SB) (Diffusion Capacity of the Lung for Carbon 
Monoxide by the Single Breath Method). The DLCO (SB) is not useful or 
valid in assessing every respiratory condition (for example, it is not 
valid in cases where the lung volume is decreased), so it is up to the 
examiner to assess whether it would provide useful information in a 
particular case. We therefore propose to add a second provision that 
would state that if the DLCO (SB) is not of record, evaluation will be 
based on alternative

[[Page 54395]]

criteria as long as the examiner states why the DLCO (SB) would not be 
useful or valid in a particular case.
    The third provision directs that when the PFT's are not consistent 
with the clinical findings, evaluation will be based on the PFT's 
unless the examiner states why they are not a valid indication of 
respiratory functional impairment in a particular case. The rationale 
for this is that PFT's are reliable, objective tests, and the 
respiratory system evaluation criteria have been revised in part to 
remove subjective assessment criteria, such as self-reported symptoms, 
in order to ensure consistent ratings. The PFT-based criteria are 
similar to the method of assessing impairment due to respiratory 
disease used by the American Thoracic Society and the American Medical 
Association Guides to the Evaluation of Permanent Impairment, 5th ed. 
(2001).
    The fourth provision states that post-bronchodilator studies are 
required when PFT's are done for disability evaluation purposes except 
when the results of pre-bronchodilator pulmonary function tests are 
normal or when an examiner determines that post-bronchodilator studies 
should not be done and states why (for example, because the patient is 
allergic to the bronchodilator). The American Lung Association/American 
Thoracic Society Component Committee on Disability Criteria recommends 
testing for pulmonary function after optimum therapy.
    The fifth provision also applies to post-bronchodilator studies and 
states that when evaluating based on PFT's, the post-bronchodilator 
results (rather than pre-bronchodilator results) will be used in 
applying the evaluation criteria in the rating schedule unless the 
post-bronchodilator results were poorer than the pre-bronchodilator 
results. In those cases, the pre-bronchodilator values will be used. 
The American Lung Association/American Thoracic Society Component 
Committee on Disability Criteria recommends testing for pulmonary 
function after optimum therapy. The best possible pulmonary function 
(which is ordinarily post-bronchodilator functioning) is the basis of 
standards for pulmonary function testing. If the bronchodilator has a 
contrary effect, the best pulmonary function would be the pre-
bronchodilator functioning.
    The sixth provision addresses cases in which there is a disparity 
between the results of different PFT's (FEV-1, FVC, etc.), so that the 
level of evaluation would differ depending on which test result is used 
to evaluate. In such cases, the test result that the examiner states 
most accurately reflects the level of disability would be used to 
evaluate.
    The seventh provision states that a decreased FEV-1/FVC ratio will 
be considered normal if the FEV-1 is greater than 100 percent. In that 
case, both the FVC and the FEV-1 would be high (better than normal), so 
a decreased ratio would not indicate pathology.

Evaluation of Certain Cardiovascular Conditions

    In 38 CFR 4.104 (Schedule of ratings--cardiovascular system), 
diagnostic codes 7000 (valvular heart disease), 7001 (endocarditis), 
7002 (pericarditis), 7003 (pericardial adhesions), 7004 (syphilitic 
heart disease), 7005 (arteriosclerotic heart disease), 7006 (myocardial 
infarction), 7007 (hypertensive heart disease), 7011 (ventricular 
arrhythmias (sustained)), 7015 (atrioventricular block), 7016 (heart 
valve replacement), 7017 (coronary bypass surgery), 7018 (implantable 
cardiac pacemakers), 7019 (cardiac transplantation), and 7020 
(cardiomyopathy) have almost identical evaluation criteria. As in the 
case of respiratory conditions, there are alternative criteria for 
evaluation at some levels, and some criteria are based on the results 
of special tests. For example, the evaluation criteria for diagnostic 
code 7000, valvular heart disease, are, in part, as follows: for a 100-
percent evaluation, chronic congestive heart failure, workload of 3 
METs (metabolic equivalents) or less results in dyspnea, fatigue, 
angina, dizziness, or syncope, or left ventricular dysfunction with an 
ejection fraction of less than 30 percent; for a 60-percent evaluation, 
more than one episode of acute congestive heart failure in the past 
year, workload of greater than 3 METs but not greater than 5 METs 
results in dyspnea, fatigue, angina, dizziness, or syncope, or left 
ventricular dysfunction with an ejection fraction of 30 to 50 percent; 
for a 30--percent evaluation, workload of greater than 5 METs but not 
greater than 7 METs results in dyspnea, fatigue, angina, dizziness, or 
syncope, or evidence of cardiac hypertrophy or dilatation on electro-
cardiogram, echocardiogram, or X-ray; and for a 10-percent evaluation, 
workload of greater than 7 METs but not greater than 10 METs results in 
dyspnea, fatigue, angina, dizziness, or syncope, or continuous 
medication required.
    There are many tests that can assess cardiac function, as the 
presence of alternative criteria at various levels indicates. Which 
ones are done in a clinical situation for a particular patient, 
however, depends on many criteria, such as the type of heart disease, 
the clinical status of the patient, the clinician's preference, the 
local availability of certain tests, etc. The alternative criteria we 
provide at a particular level of evaluation are meant to closely 
approximate one another in the degree of cardiac disability they 
represent. For example, a National Institutes of Health publication 
titled ``Heart Failure: Evaluation and Care of Patients With Left-
Ventricular Systolic Dysfunction'' (http://text.nlm.nih.gov/ahcpr/lvd/www/lvdctxt.html) states that the majority of patients with heart 
failure have moderate-to-severe left-ventricular systolic dysfunction 
and ejection fractions of less than 35-40 percent. Therefore, if 
congestive heart failure is present, the condition can be evaluated on 
that basis, with no need for a ventricular ejection fraction study to 
be conducted for rating purposes. The rating schedule requires that a 
diagnosis of cardiac enlargement or hypertrophy be supported by either 
X-ray, EKG, or echocardiogram, but it does not require that all 3 tests 
be done in every case simply for rating purposes. Our intent in 
providing alternative criteria was to avoid the need for a veteran to 
undergo additional tests that might be invasive, risky, costly, or 
time-consuming, if one or more objective and reliable tests or findings 
suitable for evaluation purposes are already of record. Although it was 
not our intent to require that a veteran undergo every test listed in 
the criteria, some individuals have interpreted the regulation as 
requiring that every veteran undergoing evaluation for one of these 
heart conditions have X-rays, an echocardiogram, a ventricular ejection 
fraction test (which can be done either by means of echocardiography or 
radionuclide ventriculography (MUGA scan)), and METs measurement (by 
exercise stress testing), in order to be certain that a higher 
evaluation based on one of the alternative criteria is not warranted. 
This regulation is proposed in order to clarify the application of 
these criteria.
    We propose to add a new Sec. 4.100, to be titled ``Application of 
the evaluation criteria for diagnostic codes 7000-7007, 7011, and 7015-
7020,'' to VA's Schedule for Rating Disabilities. This section would 
contain three provisions guiding the evaluation of specified 
cardiovascular conditions. The first provision would require the 
evaluator to ascertain in all cases whether or not cardiac hypertrophy 
or dilatation (documented by electrocardiogram, echocardiogram, or X-
ray) is present and whether or not there is a need for

[[Page 54396]]

continuous medication. Either of these would establish entitlement to a 
minimum evaluation level, and it is therefore essential to know whether 
either is present.
    A second provision would indicate that even if the requirement for 
a 10% (based on the need for continuous medication) or 30% (based on 
the presence of cardiac hypertrophy or dilatation) evaluation is met, 
METs testing is always required except in the following cases: (1) When 
there is a medical contraindication, (2) when the left ventricular 
ejection fraction has been measured and is 50% or less, (3) when 
chronic congestive heart failure is present or there has been more than 
one episode of congestive heart failure within the past year, or (4) 
when a 100% evaluation can be assigned on another basis (such as during 
the three-month period following myocardial infarction). The rationale 
for this provision is that cardiac disability may warrant a higher 
evaluation on some other basis, such as the METs level, than the 
minimum evaluations assigned for continuous medication, or cardiac 
enlargement or hypertrophy. For example, even if a veteran with 
disability due to arteriosclerotic heart disease with angina requires 
continuous medication warranting a 10-percent evaluation, the METs 
level might warrant a higher evaluation.
    The left ventricular ejection fraction (LVEF) is an objective 
measure of left ventricular function, that is, of the heart's ability 
to pump blood throughout the body. Decreased left ventricular function 
is a good indicator of the level of severity, prognosis, response to 
treatment, etc., of many heart problems. It has no value for rating 
purposes, however, unless it is decreased, because serious cardiac 
disability may be present even though the left ventricular function is 
normal. Whether an LVEF study is needed must be determined in a 
clinical setting. For rating purposes, the LVEF test is not necessary 
if there is a clinical diagnosis of either chronic congestive heart 
failure or a history of more than one episode of congestive heart 
failure within the past year because congestive heart failure of this 
degree establishes eligibility for a total (100-percent) evaluation. 
The LVEF test is also not usually necessary if METs testing, another 
very good indicator of the overall cardiovascular functional capacity, 
is available. We therefore propose that a third provision state that if 
LVEF testing is not of record, evaluation will be based on alternative 
criteria unless the examiner states that the LVEF test is needed in a 
particular case because the available medical information does not 
sufficiently reflect the severity of the veteran's cardiovascular 
disability.
    These provisions will clarify the method of evaluation of these 
heart conditions.

Evaluation of Hypertension and Hypertensive Heart Disease

    Before the cardiovascular system was revised in 1997, the 
evaluation criteria for hypertensive heart disease (diagnostic code 
7007 in Sec. 4.104 of 38 CFR), a condition that means the heart is 
enlarged or hypertrophied due to hypertension, were based in part on 
blood pressure readings. Hypertension itself was also evaluated 
primarily on the basis of blood pressure readings. Separately 
evaluating hypertension and hypertensive heart disease at that time was 
therefore prohibited because it would have meant evaluating two 
different conditions based on the same findings (or evaluating the same 
disability under two diagnoses), a process prohibited by 38 CFR 4.14, 
Avoidance of pyramiding. Since 1997, hypertensive heart disease has 
been evaluated on the same basis as most other types of heart disease, 
namely, the results of exercise testing expressed in METs, the presence 
of congestive heart failure, the ventricular ejection fraction, etc. It 
is no longer evaluated on the basis of blood pressure readings. 
Therefore, hypertension and hypertensive heart disease may now be 
separately evaluated because each has separate and independent 
evaluation criteria that do not overlap. There is therefore no conflict 
with Sec. 4.14. The rating schedule changes left some confused about 
whether or not separate evaluations for hypertension and hypertensive 
heart disease are now appropriate. To eliminate the confusion, we 
propose to add a new note (3) under diagnostic code 7101, hypertensive 
vascular disease, in Sec. 4.104, stating that hypertension will be 
separately evaluated from hypertensive heart disease and other types of 
heart disease.

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.

Executive Order 12866

    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.

Paperwork Reduction Act

    This document contains no provisions constituting a collection of 
information under the Paperwork Reduction Act (44 U.S.C. 3501-3520).

Regulatory Flexibility Act

    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, 5 
U.S.C. 601-612. The reason for this certification is that this 
amendment would not directly affect any 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 sections 603 and 604.

Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance program numbers are 
64.104 and 64.109.

List of Subjects in 38 CFR Part 4

    Disability benefits, Pensions, Veterans.

    Approved: June 26, 2002.
Anthony J. Principi,
Secretary of Veterans Affairs.
    For the reasons set out in the preamble, 38 CFR part 4 (subpart B) 
is proposed to be amended as set forth below:

PART 4--SCHEDULE FOR RATING DISABILITIES

Subpart B--Disability Ratings

    1. The authority citation for part 4 continues to read as follows:

    Authority: 38 U.S.C. 1155, unless otherwise noted.

    2. Section 4.96 is amended by adding paragraph (d) preceding the 
authority citation at the end of the section to read as follows:


Sec. 4.96  Special provisions regarding evaluation of respiratory 
conditions.

* * * * *
    (d) Special provisions for the application of evaluation criteria 
for diagnostic codes 6600, 6603, 6604, 6825-6833, and 6840-6845. (1) 
Pulmonary function tests (PFT's) are

[[Page 54397]]

required to evaluate these conditions except:
    (i) When the results of a maximum exercise capacity test are of 
record and are 20 ml/kg/min or less. If a maximum exercise capacity 
test is not of record, evaluate based on alternative criteria.
    (ii) When pulmonary hypertension (documented by an echocardiogram 
or cardiac catheterization), cor pulmonale, or right ventricular 
hypertrophy, has been diagnosed.
    (iii) When there have been one or more episodes of acute 
respiratory failure.
    (iv) When outpatient oxygen therapy is required.
    (2) If the DLCO (SB) (Diffusion Capacity of the Lung for Carbon 
Monoxide by the Single Breath Method) test is not of record, evaluate 
based on alternative criteria as long as the examiner states why the 
test would not be useful or valid in a particular case.
    (3) When the PFT's are not consistent with clinical findings, 
evaluate based on the PFT's unless the examiner states why they are not 
a valid indication of respiratory functional impairment in a particular 
case.
    (4) Post-bronchodilator studies are required when PFT's are done 
for disability evaluation purposes except when the results of pre-
bronchodilator pulmonary function tests are normal or when the examiner 
determines that post-bronchodilator studies should not be done and 
states why.
    (5) When evaluating based on PFT's, use post-bronchodilator results 
in applying the evaluation criteria in the rating schedule unless the 
post-bronchodilator results were poorer than the pre-bronchodilator 
results. In those cases, use the pre-bronchodilator values for rating 
purposes.
    (6) When there is a disparity between the results of different 
PFT's (FEV-1 (Forced Expiratory Volume in one second), FVC (Forced 
Vital Capacity), etc.), so that the level of evaluation would differ 
depending on which test result is used, use the test result that the 
examiner states most accurately reflects the level of disability.
    (7) Consider a decreased FEV-1/FVC ratio to be normal if the FEV-1 
is greater than 100 percent.
* * * * *
    3. Section 4.100 is added to read as follows:


Sec. 4.100  Application of the evaluation criteria for diagnostic codes 
7000-7007, 7011, and 7015-7020.

    (a) Whether or not cardiac hypertrophy or dilatation (documented by 
electrocardiogram, echocardiogram, or X-ray) is present and whether or 
not there is a need for continuous medication must be ascertained in 
all cases.
    (b) Even if the requirement for a 10% (based on the need for 
continuous medication) or 30% (based on the presence of cardiac 
hypertrophy or dilatation) evaluation is met, METs testing is required 
in all cases except:
    (1) When there is a medical contraindication.
    (2) When the left ventricular ejection fraction has been measured 
and is 50% or less.
    (3) When chronic congestive heart failure is present or there has 
been more than one episode of congestive heart failure within the past 
year.
    (4) When a 100% evaluation can be assigned on another basis.
    (c) If left ventricular ejection fraction (LVEF) testing is not of 
record, evaluate based on the alternative criteria unless the examiner 
states that the LVEF test is needed in a particular case because the 
available medical information does not sufficiently reflect the 
severity of the veteran's cardiovascular disability.
    4. Section 4.104, diagnostic code 7101 is amended by adding a Note 
3 to read as follows:


Sec. 4.104  Schedule of ratings--cardiovascular system.

                          Diseases of the Heart
------------------------------------------------------------------------
                                                                 Rating
------------------------------------------------------------------------
                  *        *        *        *        *
7101  Hypertensive vascular disease (hypertension and isolated
 systolic hypertension):
                  *        *        *        *        *
------------------------------------------------------------------------


    Note (3): Evaluate hypertension separately from hypertensive 
heart disease and other types of heart disease.

* * * * *
[FR Doc. 02-21366 Filed 8-21-02; 8:45 am]
BILLING CODE 8320-01-P