[Federal Register Volume 66, Number 105 (Thursday, May 31, 2001)]
[Rules and Regulations]
[Pages 29486-29489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-13626]


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

DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 4

RIN 2900-AK12


Schedule for Rating Disabilities: Disabilities of the Liver

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

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

SUMMARY: This document amends the Department of Veterans Affairs (VA) 
Schedule for Rating Disabilities (38 CFR part 4) by revising the 
portion of the Digestive System that addresses disabilities of the 
liver. The intended effect of this action is to update this portion of 
the rating schedule to ensure that it uses current medical terminology 
and unambiguous criteria, and that it reflects medical advances that 
have occurred since the last review.

DATES: Effective Date: This rule is effective July 2, 2001.

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: As part of its review of the Schedule for 
Rating Disabilities (38 CFR part 4), VA published a proposal to amend 
that portion of the Schedule pertaining to liver disabilities. The 
proposed rule was published in the Federal Register on August 7, 2000 
(65 FR 48205). Interested persons were invited to submit written 
comments on or before October 6, 2000. We received comments from the 
Disabled American Veterans and one VA employee.
    In the preamble of the proposed rule, we proposed to delete 
diagnostic code 7313 but inadvertently did not include this change in 
the amendatory instructions portion of the document. No comment was 
made on this proposed change which is now reflected in the final rule.
    One commenter questioned our proposal to provide percentage 
evaluation levels of 10, 30, 50, 70, and 100% for diagnostic code 7312 
(cirrhosis of the liver, primary biliary cirrhosis, or cirrhotic phase 
of sclerosing cholangitis) and levels of zero, 10, 20, 40, 60, and 100% 
for diagnostic codes 7345 (chronic liver disease without cirrhosis 
(including hepatitis B, chronic active hepatitis, autoimmune hepatitis, 
hemochromatosis, drug-induced hepatitis, etc., but excluding bile duct 
disorders and hepatitis C)) and 7354 (hepatitis C (or non-A, non-B 
hepatitis)). The commenter felt all of these conditions should have the 
same evaluation levels because the symptom criteria are almost 
identical.
    We do not adopt the comment for the following reasons. The symptom 
criteria for cirrhotic and non-cirrhotic liver diseases are not nearly 
identical. The evaluation criteria proposed for cirrhotic diseases 
(diagnostic code 7312) are based on largely objective signs, symptoms, 
and complications of cirrhosis, such as jaundice, weakness, weight 
loss, ascites, hepatic encephalopathy, and hemorrhage. The evaluation 
levels for cirrhotic diseases have not been changed, except for the 
addition of the 10 percent rating recommended by our consultants. The 
evaluation criteria proposed for non-cirrhotic diseases (diagnostic 
codes 7345 and 7354) are based primarily on specific signs and symptoms 
of hepatitis or other chronic liver disease without cirrhosis, such as 
fatigue, malaise, nausea, vomiting, anorexia, arthralgia, and right 
upper quadrant pain. Alternatively, non-cirrhotic liver disease and 
hepatitis C may be rated or on an alternative set of criteria based on 
incapacitating episodes if it will result in a higher evaluation. VA 
proposed in the Federal Register on February 24, 1996 (62 FR 8204) to 
also rate intervertebral disc syndrome based on incapacitating 
episodes. To maintain internal consistency in the rating schedule, we 
are using the same percentage evaluation levels that we proposed for 
rating intervertebral disc syndrome when it is based on incapacitating 
episodes. The evaluation levels for cirrhotic diseases, however, are 
not based on incapacitating episodes. Accordingly, we do not believe 
using the same levels of evaluation for such diseases is appropriate, 
and we have not adopted the commenter's suggestion.
    The same commenter suggested that we provide criteria for 
diagnostic code 7312 based on incapacitating episodes, as we have done 
for hepatitis or other chronic liver disease without cirrhosis.
    Cirrhosis results in liver scarring and progressive liver damage 
that eventually leads to liver decompensation with the complications of 
hemorrhage, encephalopathy, ascites, or jaundice. Treatment is aimed at 
preventing the progression of liver damage, but it cannot reverse it, 
because it is permanent. Since cirrhosis does not have an overall 
episodic course, although its complications may occur intermittently 
once it has reached the decompensated stage, an alternative set of 
criteria based on incapacitating episodes is not appropriate, and we 
have not adopted this suggestion.
    Section 4.112 currently addresses weight loss in general terms for 
purposes of application to Sec. 4.114. We proposed to revise this 
section by defining these terms in more detail and referencing them to 
the individual's ``baseline weight.'' For example, we proposed to 
define ``substantial weight loss,'' as meaning a loss of greater than 
20 percent of the individual's baseline weight, sustained for three 
months or longer. One commenter recommended that we include some 
guidance for determining baseline weight because a

[[Page 29487]]

small variation in the way the baseline weight is determined could make 
a material difference in the disability rating assigned.
    In response to this comment, we have added a sentence to Sec. 4.112 
defining ``baseline weight'' as the average weight for the two-year-
period preceding onset of the disease. This will assure that the usual 
weight over a reasonable period of time before the disease began is the 
basis of determining subsequent weight loss.
    We proposed to revise the criteria for evaluating residuals of 
injury to the liver (diagnostic code 7311) from rating under the 
criteria for peritoneal adhesions to rating as adhesions of peritoneum 
(diagnostic code 7301), cirrhosis of liver (diagnostic code 7312), or 
chronic liver disease without cirrhosis (diagnostic code 7345), 
depending on the specific residuals. One commenter stated that 
individuals may have both liver damage and peritoneal adhesions, and 
that we should therefore indicate that these residuals should be 
separately evaluated and then combined, rather than evaluating based on 
only one type of residual.
    We agree that this should be clarified, and have revised the 
criteria to ``Depending on the specific residuals, separately evaluate 
as adhesions of peritoneum (diagnostic code 7301), cirrhosis of liver 
(diagnostic code 7312), and chronic liver disease without cirrhosis 
(diagnostic code 7345).''
    One commenter suggested we alter the order of presentation of the 
criteria and punctuation for diagnostic code 7312 at the 100-percent 
evaluation level from ``With one of the following refractory to 
treatment: ascites, hepatic encephalopathy, or hemorrhage from varices 
or portal gastropathy (erosive gastritis), or; with persistent 
jaundice, generalized weakness, and substantial weight loss'' to ``With 
persistent jaundice, generalized weakness, and substantial weight loss; 
or with one of the following refractory to treatment: ascites, hepatic 
encephalopathy, hemorrhage from varices or portal gastropathy (erosive 
gastritis).'' The commenter recommended similar punctuation changes 
under diagnostic codes 7345 and 7354.
    For the sake of clarity, we have rearranged the order of the 
criteria under diagnostic code 7312, but prefer to retain the comma and 
semicolon to distinguish the criteria. We have used this method of 
punctuation in other sections of the rating schedule (e.g. 38 CFR 
4.88b, diagnostic code 6314 and 38 CFR 4.104, diagnostic code 7000) to 
emphasize a clear separation of alternative criteria and wish to be 
consistent in punctuation. A change here might imply a difference in 
meaning that we do not intend. We have not adopted the suggested 
punctuation changes for diagnostic codes 7345 and 7354 for the same 
reasons.
    One commenter felt that, in the proposed criteria for a 100-percent 
evaluation under diagnostic code 7312, it was unclear whether the word 
``persistent'' modifies all 3 manifestations in the phrase ``persistent 
jaundice, generalized weakness, and substantial weight loss,'' and 
suggested that we clarify.
    There was no intent that ``persistent'' modify all three nouns. To 
assure clarity, we have revised that phrase each time it appears to 
read ``generalized weakness, substantial weight loss, and persistent 
jaundice.''
    One commenter expressed concerns about the criteria under 
diagnostic codes 7345 and 7354 for a 100-percent evaluation. The 
criteria we proposed are: ``Near-constant incapacitating symptoms (such 
as fatigue, malaise, nausea, vomiting, anorexia, arthralgia, and right 
upper quadrant pain).'' For a 60-percent evaluation, we proposed: 
``Incapacitating episodes (with symptoms such as fatigue, malaise, 
nausea, vomiting, anorexia, arthralgia, and right upper quadrant pain) 
having a total duration of at least six weeks during the past 12-month 
period, but not occurring constantly, or; with daily fatigue, malaise, 
and anorexia, with substantial weight loss (or other indication of 
malnutrition), and hepatomegaly.'' The commenter felt that the term 
``incapacitating symptoms'' under the 100-percent evaluation criteria 
has essentially the same meaning as ``incapacitating episodes'' at 
other levels of evaluation, and that a veteran would have to be 
bedridden to meet the criteria for a 100-percent evaluation. The 
commenter said this does not conform to 38 U.S.C. 1155, which states 
that the rating schedule must be based on the average impairment of 
earning capacity.
    A note under diagnostic codes 7345 and 7354 in the proposed rule 
defines the term ``incapacitating episodes'' for purposes of those 
codes. That definition is necessary because there is no generally 
understood meaning of ``incapacitating episodes'' as it is used for 
evaluation purposes. We have therefore defined the term to mean 
episodes of sudden onset and limited duration, but severe enough to 
require bed rest and treatment by a physician. As used in the rating 
schedule, the term ``near-constant incapacitating symptoms'' refers to 
symptoms that, because of their severity and persistence, render the 
average individual unable to work. The word ``incapacitating'' is 
defined as ``to make unable or unfit; esp., to make incapable of normal 
activity; disable.'' (Webster's New World Dictionary, Third College 
Edition, 681). Therefore, the term ``incapacitating symptoms'' does not 
require bed rest. To eliminate any possible confusion, however, we have 
changed the term ``near-constant incapacitating symptoms'' at the 100-
percent level to ``near-constant debilitating symptoms.'' Use of the 
analogous term ``debilitating'' will eliminate any possible confusion 
that might arise from the use of the terms ``incapacitating episodes'' 
and ``incapacitating symptoms.''
    The same commenter objected to the retrospective nature of the 
criteria for diagnostic codes 7345 and 7354 when evaluation is based on 
incapacitating episodes on the grounds that a veteran might have to 
endure financial hardship for twelve months or more before being 
adequately compensated.
    In the great majority of cases, veterans with non-cirrhotic liver 
disease will be evaluated using the criteria based on signs and 
symptoms of liver disease. Using those criteria does not require a 12-
month period of observation before assigning an evaluation because they 
are based on current medical evidence of the chronic severity of the 
disease. The criteria based on incapacitating episodes, although they 
will be used infrequently, provide an avenue for a potentially higher 
evaluation. It will often not be necessary to wait 12 months in order 
to rate a veteran based upon incapacitating episodes if, for example, 
the medical evidence of record indicates how many episodes the veteran 
has experienced in the previous 12 months, or if there are 
incapacitating episodes of sufficient duration to allow the assignment 
of a higher evaluation than one based on symptoms, even though they 
have occurred over a less than 12-month period. However, in order to 
indicate more clearly that using signs and symptoms is the primary 
method of evaluating the severity of these diseases, we have reversed 
the order of the two sets of alternative criteria for diagnostic codes 
7345 and 7354 so that signs and symptoms, i.e., the primary basis of 
evaluation, comes first.
    As an extension of the comment objecting to the retrospective 
nature of the criteria for diagnostic codes 7345 and 7354, the same 
commenter said that more frequent ratings would be needed in these 
cases in order to achieve stable evaluations.

[[Page 29488]]

    As we explained above, most veterans will be rated on the basis of 
the signs and symptoms of liver disease, and these are not likely to 
change rapidly because the course of these liver diseases is commonly 
slow and prolonged, at least until the latter stages of disease. Most 
persons with non-cirrhotic liver disease and hepatitis C experience a 
steadily declining course. Periods of incapacitating episodes followed 
by substantial improvement or rapid decline would be very unusual. 
Given the course of these diseases, it is unlikely that re-evaluations 
would be needed more frequently than with other disabilities, and we 
have made no change based on this comment.
    The same commenter urged that a better way (other than using 
incapacitating episodes as the basis of evaluation) be found to 
evaluate the severity of diseases that are characterized by recurring 
exacerbations. The commenter suggested no alternative method of 
evaluating recurring exacerbations. We believe that evaluating them 
based on incapacitating episodes is a fair and reasonable way to assess 
them, and will promote consistency across the rating schedule, in that 
different diseases will be rated at the same level if they result in 
the same duration of periods of incapacitation.
    VA appreciates the comments submitted in response to the proposed 
rule. Based on the rationale stated in the proposed rule and in this 
document, the proposed rule, is adopted with the changes noted above.

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 (RFA), 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.

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.

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

List of Subjects in 38 CFR Part 4

    Disability benefits, Individuals with disabilities, Pensions, 
Veterans.

    Approved: March 5, 2001.
Anthony J. Principi,
Secretary of Veterans Affairs.

    For the reasons set out in the preamble, 38 CFR part 4, subpart B, 
is amended as set forth below:

PART 4--SCHEDULE FOR RATING DISABILITIES

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

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


    2. Section 4.112 is revised to read as follows:


Sec. 4.112  Weight Loss.

    For purposes of evaluating conditions in Sec. 4.114, the term 
``substantial weight loss'' means a loss of greater than 20 percent of 
the individual's baseline weight, sustained for three months or longer; 
and the term ``minor weight loss'' means a weight loss of 10 to 20 
percent of the individual's baseline weight, sustained for three months 
or longer. The term ``inability to gain weight'' means that there has 
been substantial weight loss with inability to regain it despite 
appropriate therapy. ``Baseline weight'' means the average weight for 
the two-year-period preceding onset of the disease.

(Authority: 38 U.S.C. 1155)

    3. Section 4.114 is amended by:
    A. Revising diagnostic codes 7311, 7312, 7343, 7344, and 7345.
    B. Removing diagnostic code 7313.
    C. Adding diagnostic codes 7351 and 7354.
    D. Adding a new authority citation at the end of the section.
    The revisions and additions read as follows:


Sec. 4.114  Schedule of ratings-digestive system.

* * * * *

------------------------------------------------------------------------
 
------------------------------------------------------------------------
                                                                 Rating
7311  Residuals of injury of the liver:
    Depending on the specific residuals, separately evaluate   .........
     as adhesions of peritoneum (diagnostic code 7301),
     cirrhosis of liver (diagnostic code 7312), and chronic
     liver disease without cirrhosis (diagnostic code 7345)..
7312  Cirrhosis of the liver, primary biliary cirrhosis, or
 cirrhotic phase of sclerosing cholangitis:
    Generalized weakness, substantial weight loss, and               100
     persistent jaundice, or; with one of the following
     refractory to treatment: ascites, hepatic
     encephalopathy, hemorrhage from varices or portal
     gastropathy (erosive gastritis).........................
    History of two or more episodes of ascites, hepatic               70
     encephalopathy, or hemorrhage from varices or portal
     gastropathy (erosive gastritis), but with periods of
     remission between attacks...............................
    History of one episode of ascites, hepatic                        50
     encephalopathy, or hemorrhage from varices or portal
     gastropathy (erosive gastritis).........................
    Portal hypertension and splenomegaly, with weakness,              30
     anorexia, abdominal pain, malaise, and at least minor
     weight loss.............................................
    Symptoms such as weakness, anorexia, abdominal pain, and          10
     malaise.................................................
 
 Note: For evaluation under diagnostic code 7312, documentation of
 cirrhosis (by biopsy or imaging) and abnormal liver function tests must
 be present.
  *                  *                  *                  *
                  *                  *                  *
7343  Malignant neoplasms of the digestive system, exclusive         100
 of skin growths.............................................
 
 Note: A rating of 100 percent shall continue beyond the cessation of
 any surgical, X-ray, antineoplastic chemotherapy or other therapeutic
 procedure. Six months after discontinuance of such treatment, the
 appropriate disability rating shall be determined by mandatory VA
 examination. Any change in evaluation based upon that or any subsequent
 examination shall be subject to the provisions of Sec.  3.105(e) of
 this chapter. If there has been no local recurrence or metastasis, rate
 on residuals.
7344  Benign neoplasms, exclusive of skin growths:
    Evaluate under an appropriate diagnostic code, depending   .........
     on the predominant disability or the specific residuals
     after treatment.........................................
7345  Chronic liver disease without cirrhosis (including
 hepatitis B, chronic active hepatitis, autoimmune hepatitis,
 hemochromatosis, drug-induced hepatitis, etc., but excluding
 bile duct disorders and hepatitis C):
    Near-constant debilitating symptoms (such as fatigue,            100
     malaise, nausea, vomiting, anorexia, arthralgia, and
     right upper quadrant pain)..............................
    Daily fatigue, malaise, and anorexia, with substantial            60
     weight loss (or other indication of malnutrition), and
     hepatomegaly, or; incapacitating episodes (with symptoms
     such as fatigue, malaise, nausea, vomiting, anorexia,
     arthralgia, and right upper quadrant pain) having a
     total duration of at least six weeks during the past 12-
     month period, but not occurring constantly..............

[[Page 29489]]

 
    Daily fatigue, malaise, and anorexia, with minor weight           40
     loss and hepatomegaly, or; incapacitating episodes (with
     symptoms such as fatigue, malaise, nausea, vomiting,
     anorexia, arthralgia, and right upper quadrant pain)
     having a total duration of at least four weeks, but less
     than six weeks, during the past 12-month period.........
    Daily fatigue, malaise, and anorexia (without weight loss         20
     or hepatomegaly), requiring dietary restriction or
     continuous medication, or; incapacitating episodes (with
     symptoms such as fatigue, malaise, nausea, vomiting,
     anorexia, arthralgia, and right upper quadrant pain)
     having a total duration of at least two weeks, but less
     than four weeks, during the past 12-month period........
    Intermittent fatigue, malaise, and anorexia, or;                  10
     incapacitating episodes (with symptoms such as fatigue,
     malaise, nausea, vomiting, anorexia, arthralgia, and
     right upper quadrant pain) having a total duration of at
     least one week, but less than two weeks, during the past
     12-month period.........................................
    Nonsymptomatic...........................................          0
 
Note (1): Evaluate sequelae, such as cirrhosis or malignancy of the
 liver, under an appropriate diagnostic code, but do not use the same
 signs and symptoms as the basis for evaluation under DC 7354 and under
 a diagnostic code for sequelae. (See Sec.  4.14.).
Note (2): For purposes of evaluating conditions under diagnostic code
 7345, ``incapacitating episode'' means a period of acute signs and
 symptoms severe enough to require bed rest and treatment by a
 physician.
Note (3): Hepatitis B infection must be confirmed by serologic testing
 in order to evaluate it under diagnostic code 7345.
  *                  *                  *                  *
                  *                  *                  *
7351  Liver transplant:
    For an indefinite period from the date of hospital               100
     admission for transplant surgery........................
    Minimum..................................................         30
 
 Note: A rating of 100 percent shall be assigned as of the date of
 hospital admission for transplant surgery and shall continue. One year
 following discharge, the appropriate disability rating shall be
 determined by mandatory VA examination. Any change in evaluation based
 upon that or any subsequent examination shall be subject to the
 provisions of Sec.  3.105(e) of this chapter.
7354  Hepatitis C (or non-A, non-B hepatitis):
    With serologic evidence of hepatitis C infection and the
     following signs and symptoms due to hepatitis C
     infection:
        Near-constant debilitating symptoms (such as fatigue,        100
         malaise, nausea, vomiting, anorexia, arthralgia, and
         right upper quadrant pain)..........................
        Daily fatigue, malaise, and anorexia, with                    60
         substantial weight loss (or other indication of
         malnutrition), and hepatomegaly, or; incapacitating
         episodes (with symptoms such as fatigue, malaise,
         nausea, vomiting, anorexia, arthralgia, and right
         upper quadrant pain) having a total duration of at
         least six weeks during the past 12-month period, but
         not occurring constantly............................
        Daily fatigue, malaise, and anorexia, with minor              40
         weight loss and hepatomegaly, or; incapacitating
         episodes (with symptoms such as fatigue, malaise,
         nausea, vomiting, anorexia, arthralgia, and right
         upper quadrant pain) having a total duration of at
         least four weeks, but less than six weeks, during
         the past 12-month period............................
        Daily fatigue, malaise, and anorexia (without weight          20
         loss or hepatomegaly), requiring dietary restriction
         or continuous medication, or; incapacitating
         episodes (with symptoms such as fatigue, malaise,
         nausea, vomiting, anorexia, arthralgia, and right
         upper quadrant pain) having a total duration of at
         least two weeks, but less than four weeks, during
         the past 12-month period............................
        Intermittent fatigue, malaise, and anorexia, or;              10
         incapacitating episodes (with symptoms such as
         fatigue, malaise, nausea, vomiting, anorexia,
         arthralgia, and right upper quadrant pain) having a
         total duration of at least one week, but less than
         two weeks, during the past 12-month period..........
    Nonsymptomatic...........................................          0
 
 Note (1): Evaluate sequelae, such as cirrhosis or malignancy of the
 liver, under an appropriate diagnostic code, but do not use the same
 signs and symptoms as the basis for evaluation under DC 7354 and under
 a diagnostic code for sequelae. (See Sec.  4.14.).
Note (2): For purposes of evaluating conditions under diagnostic code
 7354, ``incapacitating episode'' means a period of acute signs and
 symptoms severe enough to require bed rest and treatment by a
 physician.
------------------------------------------------------------------------

(Authority: 38 U.S.C. 1155)

[FR Doc. 01-13626 Filed 5-30-01; 8:45 am]
BILLING CODE 8320-01-P