[Federal Register Volume 66, Number 220 (Wednesday, November 14, 2001)]
[Proposed Rules]
[Pages 57009-57021]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-28455]


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SOCIAL SECURITY ADMINISTRATION

20 CFR Part 404

[Regulations No. 4]
RIN 0960-AF28


Revised Medical Criteria for Evaluating Impairments of the 
Digestive System

AGENCY: Social Security Administration.

ACTION: Proposed rules.

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SUMMARY: We are proposing to revise the criteria in the Listing of 
Impairments (the Listings) that we use to evaluate claims involving 
digestive impairments. We apply these criteria at step three of our 
sequential evaluation processes when you claim benefits based on 
disability under title II and title XVI of the Social Security Act (the 
Act). The proposed revisions will reflect advances in medical 
knowledge, treatment, and methods of evaluating digestive impairments. 
We also propose to remove listings that are redundant and only refer to 
other listings.

DATES: To be sure your comments are considered, we must receive them by 
January 14, 2002.

ADDRESSES: You may give us your comments by using: our Internet site 
facility (i.e., Social Security Online) at http://www.ssa.gov/regulations/index.htm, e-mail to [email protected], telefax to (410) 
966-2830 or by sending a letter to the Commissioner of Social Security, 
P.O. Box 17703, Baltimore, Maryland 21235-7703. You may also deliver 
them to the Office of Process and Innovation Management, Social 
Security Administration, L2109 West Low Rise Building, 6401 Security 
Boulevard, Baltimore, Maryland 21235-6401, between 8 a.m. and 4 p.m. on 
regular business days. We post comments on our Internet site, or you 
may inspect them on regular business days by making arrangements with 
the contact person shown in this preamble.
    A list of the sources we consulted when developing these proposed 
rules, e.g., various medical texts and pertinent articles, will be 
posted on the above Internet site. The list is also available upon 
request by letter to the Office of Disability, Division of Medical & 
Vocational Policy, Social Security Administration, 3A-8 
Operations Building, 6401 Security Boulevard, Baltimore, MD 21235, 
Attn: Cheryl Wrobel, or by email to [email protected]. Electronic 
Version: The electronic file of this document is available on the date 
of

[[Page 57010]]

publication in the Federal Register on http://www.access.gpo.gov/su_docs/aces/aces140.html. It is also available on the Internet site 
for SSA (i.e., Social Security Online): http://www.ssa.gov/regulations/. Electronic copies of the public comments on these 
proposed rules may also be found on this site.

FOR FURTHER INFORMATION CONTACT: Suzanne DiMarino, Social Insurance 
Specialist, Office of Process and Innovation Management, Social 
Security Administration, 2109 West Low Rise, 6401 Security Boulevard, 
Baltimore, Maryland 21235-6401, (410) 965-1769 or TTY (410) 966-5609. 
For information on eligibility or filing for benefits, call our 
national toll-free number 1-800-772-1213 or TTY 1-800-325-0778, or 
visit our Internet web site, SSA Online, at www.ssa.gov.

SUPPLEMENTARY INFORMATION:

What Programs Would These Proposed Regulations Affect?

    These proposed regulations would affect disability determinations 
and decisions we make for you under title II and title XVI of the Act. 
In addition, to the extent that Medicare and Medicaid eligibility are 
based on entitlement to benefits under title II and eligibility for 
benefits under title XVI, these proposed regulations would also affect 
the Medicare and Medicaid programs.

Who Can Get Disability Benefits?

    Under title II of the Act, we provide for the payment of disability 
benefits if you are disabled and belong to one of the following three 
groups:
     Workers insured under the Act;
     Children of insured workers; and
     Widows, widowers, and surviving divorced spouses of 
insured individuals.
    Under title XVI of the Act, we provide for Supplemental Security 
Income (SSI) payments on the basis of disability if you have limited 
income and resources.

How Do We Define Disability?

    Under both the title II and title XVI programs, disability must be 
the result of any medically determinable physical or mental impairment 
or combination of impairments that can be expected to result in death 
or that has lasted or can be expected to last for a continuous period 
of at least 12 months. Our definitions of disability are shown in the 
following table:

------------------------------------------------------------------------
                                                    Disability means you
                                                      have a medically
                                                        determinable
 If you file a claim under * *  And you are * * *    impairment(s) that
               *                                    meets the statutory
                                                    duration requirement
                                                    and results in * * *
------------------------------------------------------------------------
title II......................  an adult or child  the inability to do
                                                    any substantial
                                                    gainful activity
                                                    (SGA).
title XVI.....................  an adult.........  the inability to do
                                                    any SGA.
title XVI.....................  a child..........  marked and severe
                                                    functional
                                                    limitations.
------------------------------------------------------------------------

What Are the Listings and How Do We Use Them?

    The Listings, found in appendix 1 to subpart P of part 404 of our 
regulations, are examples of impairments for each of the major body 
systems that we consider severe enough to preclude you as an adult from 
performing any gainful activity, without further considering their 
functional impact or your age, education and work experience. If you 
are a child seeking SSI benefits based on disability, the listings 
describe impairments that we consider severe enough to result in marked 
and severe functional limitations. We generally use the criteria in the 
Listings only to make findings of disability. Although the Listings are 
found only in part 404 of our rules, we incorporate them into the SSI 
program under title XVI of the Act by Sec. 416.925 of our regulations, 
and apply them to claims under both title II and title XVI of the Act.
    There are listings for adults (part A) and for children (part B). 
We apply the medical criteria in part A when we assess your claim if 
you are an adult, i.e., a person age 18 or over. If you are a child, we 
first use the criteria in part B. If the B criteria do not apply, and 
the specific disease process(es) has a similar effect on adults and 
children, we then use the criteria in part A.
    Our regulations provide for sequential evaluation processes for 
evaluating disability. We apply the Listings at step three of the 
sequential evaluation processes for adults and for children. First, we 
must determine that you are not engaging in substantial gainful 
activity, and, second, that you have a medically determinable 
impairment or combination of impairments that is ``severe.''
    Then, at step 3 of both processes, we use the Listings to determine 
if you have an impairment(s) that meets or equals in severity the 
criteria of a listed impairment.

Why Are We proposing To revise the Listings for Digestive 
Impairments?

    We have reviewed the existing digestive listings and have 
determined they should be revised in light of medical advances in 
evaluation and treatment. We last published final rules revising the 
digestive listings in the Federal Register on December 6, 1985 (50 FR 
50068). In the preamble to those rules, we said that due to medical 
advances in treatment and program experience, we would periodically 
review and update the Listings. The current listings for the digestive 
system will no longer be effective on July 2, 2003. We are now 
proposing to revise the listings in Part A, 5.00 and in Part B, 105.00. 
We are proposing to make the rules effective for five years from the 
effective date of the final rules we publish in the Federal Register, 
unless we extend them, or revise and issue them again.
    We will continue to apply our current listings until we evaluate 
the public comments on these proposed rules and determine whether they 
should be issued as final rules. If we finalize these proposed rules, 
when any final rules become effective, we will apply them to new 
applications filed on or after the effective date of the final rules, 
and to cases that are pending in the administrative review process. In 
accordance with our usual practice, we would explain how we would apply 
any final rules in greater detail in the preamble to the final rules.
    When we conduct reviews to determine whether your disability 
continues, we would not find that your disability has ended based only 
on any changes in the listings. Our regulations explain that we 
continue to use our prior listings when we review your case if you 
receive disability benefits or SSI payments based on our determination 
or decision that your impairment(s) met or equaled the listings. In 
these cases, we determine whether you have experienced medical 
improvement, and if so, whether the medical improvement is related to 
the ability to work. If your impairment(s) still meets or equals the 
same listing section that we used to make our most recent favorable 
determination or decision, we will find the medical improvement is not 
related to the ability to work. If your condition has medically 
improved so that you no longer meet or equal the prior listing, we 
evaluate your case further to determine whether you are currently 
disabled. We may find that you are

[[Page 57011]]

currently disabled, depending on the full circumstances of your case. 
See 20 CFR 404.1594(c)(3)(i), 416.994(b)(2)(iv)(A). If you are a child 
who is eligible for SSI payments, we follow a similar rule when we 
decide whether you have experienced medical improvement in your 
condition. 20 CFR 416.994a(b)(2).

What General Revisions Are We Proposing for the Digestive System 
Listings?

    We propose to clarify the listing criteria and to make the listings 
easier to use by:
    1. Replacing reference listings with guidance in the preface. 
Reference listings are listings that are met by satisfying the criteria 
of another listing. For example, you can meet current listing 5.03, 
Stricture, stenosis, or obstruction of the esophagus, with weight loss 
as described under listing 5.08. Current listing 5.08 requires weight 
loss to a specific amount due to any persisting gastrointestinal 
disorder. Therefore current listing 5.03 is redundant.
    We also propose to provide general guidance in the preface to the 
listings (see Section 5.00E1) stating that digestive disorders 
resulting in impairments in other body systems should be evaluated 
under the affected body system. We propose to list the most commonly 
affected body systems.
    2. Making nonsubstantive editorial changes to update the medical 
terminology in the Listings and to be consistent with plain language 
guidelines. Plain language regulations will make the content easier to 
understand.
    We discuss other specific changes we propose to make in the 
listings below, in our detailed explanation of the proposed listings.

How Are We Proposing to Change the Preface to the Listings for 
Evaluating Digestive Impairments in Adults?

5.00  Digestive System

    We propose to revise the preface to provide additional guidance for 
adjudicating digestive impairments, and to update the medical 
terminology. We also propose to remove references to disorders and 
complications of diseases that we no longer always consider to result 
in listing-level severity, e.g., peptic ulcer disease, fistulae, 
abscesses, or recurrent obstructions.
    The remaining relevant material in current section 5.00A is in 
proposed section 5.00A, while the relevant material in current 5.00B is 
updated and moved to proposed section 5.00F.
    The relevant material in current section 5.00C is moved to proposed 
section 5.00A. We propose to remove that portion of current section 
5.00C that deals with peptic ulcer disease because advances in 
diagnosis, evaluation and treatment of this impairment make the 
surgical interventions discussed in the current section (including 
gastrectomy, vagotomy and pyloroplasty) much less common.
    Following is a detailed explanation, section-by-section, of the 
proposed revised preface material.

Proposed 5.00A--What Kind of Impairments Do We Consider in the 
Digestive System?

    In this section, we propose to list examples of major digestive 
impairments reflected in the digestive listings. We propose to move the 
information about colostomy and ileostomy from current section 5.00C to 
proposed section 5.00A. as part of a general reorganization of the 
material.
    The proposed rules continue to recognize that digestive impairments 
frequently respond to medical or surgical therapy. As a result, the 
severity of these disorders should generally be considered within the 
context of prescribed treatment.

Proposed 5.00B--What Documentation Do We Need?

    In this new section, we propose to add examples of the types of 
clinical and laboratory findings that should be part of the 
longitudinal evidence. We also state that we usually need longitudinal 
evidence covering a period of at least 6 months of observations and 
treatment, unless we can make a fully favorable determination or 
decision without it. With advances in medication and treatment, 
favorable response to treatment may reduce the functional impact of 
digestive impairments. We believe the 6-month evidence period should 
allow sufficient time for your impairment to stabilize so we can make 
an accurate projection regarding its severity and duration. However, 
this does not prevent us from making a finding of disability before the 
6-month period elapses, after considering all of the medical and other 
evidence. The rules we have proposed will provide us with flexibility 
to address situations in which your medical condition is so severe that 
we can determine before the 6-month period elapses that your 
impairment(s) will continue to be disabling for at least 12 months. One 
example would be under listing 5.02, recurrent gastrointestinal 
hemorrhage, if 3 distinct episodes are documented in less than 6 
months. Another example would be an impairment that meets listing 5.09 
Liver transplant, due to a traumatic event or previously unrecognized 
and untreated liver condition with little or no pre-surgical treatment 
documentation.
    We also provide guidance on those situations when you have not 
received ongoing treatment or do not have an ongoing relationship with 
the medical community despite the existence of a severe impairment.

Proposed 5.00C--How Do We Evaluate Digestive Disorders Under 
Listings That Require Recurring or Persistent Findings?

    We propose this new section to discuss the requirement for 
recurring or persistent findings in listings 5.02, 5.05, 5.06 and 5.08, 
and other considerations which allow us to make findings regarding 
continued impairment severity to satisfy the duration of disability 
requirement.
    We also discuss the events and episodes needed to meet certain 
listings. There are no minimal periods of time for which an episode has 
to last, although for some listings, all incidents within a specified 
period will constitute one episode. The duration of an episode is 
controlled by the requirements that constitute an episode for a 
specific disorder. For example, the requirement for blood transfusion 
inherently implies that you must seek medical care that results in the 
appropriate clinical and laboratory evaluation to determine that 
transfusion is necessary.
    The required number of recurrent episodes is specified in each 
listing. Listings 5.02, 5.06, 105.05A, and 105.06A are characterized by 
``episodes.''
    Listing 5.02 requires 3 episodes of gastrointestinal hemorrhage 
requiring at least two units of blood transfused per episode, occurring 
during a consecutive 6-month period. Listing 5.02 further qualifies 
that all incidents occurring within a consecutive 14-day period 
constitute one episode. Listing 5.06 and 105.06A require documentation 
of at least two episodes of abdominal pain, distention, and vomiting as 
a result of inflammatory bowel disease, which is documented as required 
in the listing. These episodes must occur during the consecutive 6-
month period of persistent or recurrent intestinal obstruction that 
occurs despite prescribed treatment. Listing 105.05A requires 3 
episodes of bleeding requiring transfusion due to hemodynamic 
instability, occurring over a consecutive 6-month period.

[[Page 57012]]

    Section 5.00C2 and 105.00C2 explain: * * * In every listing in 
which we require more than one event, there must be at least 1 month 
between the events (unless otherwise specified), to ensure that we are 
evaluating separate episodes.''

Proposed 5.00D--How Do We Consider the Effects of Treatment?

    We propose this new section to describe our policy on assessing the 
effects of treatment when we determine the severity and duration of the 
impairment.

Proposed 5.00E--How Do We Evaluate Impairments That Do Not Meet One 
of the Digestive Listings?

    In this new section, we propose guidance for assessing digestive 
impairments that do not meet the digestive listings, but are 
accompanied by systemic manifestations in other body systems. For 
example, we site hepatic encephalopathy to explain that the resultant 
impairment should be evaluated under the affected body system. This 
replaces the criteria in current listing 5.05E, which states the 
impairment should be evaluated under the criteria in listing 12.02.
    We also explain how evaluation of the impairment(s) will continue 
through the sequential evaluation process.

Proposed 5.00F--What Are Our Guidelines for Evaluating Specific 
Digestive Impairments?

    We incorporated and revised the guidance in current 5.00B into this 
proposed section. We removed the discussion in current section 5.00B 
about a distinction between primary and secondary digestive disorders 
resulting in weight loss and malnutrition since the distinction is not 
necessary for adjudication. Rather, the weight loss must only be shown 
to be related to a digestive impairment. When a medically determinable 
impairment is established, we do not require that a direct connection 
with a specific etiology be determined. The wording in current 5.00B 
can be incorrectly interpreted to imply that we must determine that the 
digestive disorder is the primary or secondary cause of the weight 
loss. Since this is not necessary for our disability evaluation 
process, we propose to revise the section. If you have a digestive 
disorder that can reasonably be expected to lead to weight loss, or a 
treating source actually states that weight loss results from a 
specific digestive disorder, this is sufficient for our purposes.
    We added an explanation of how to use the weight tables in Listing 
5.08, when fractions of inches or centimeters in height measurements 
must be converted to specific table values.
    We also propose to add a new section, 5.00F2, which describes how 
we evaluate chronic liver disease and resulting impairments, including 
liver transplants.

How Are We Proposing to Change the Criteria in the Listings for 
Evaluating Digestive Impairments in Adults?

5.01  Category of Impairments, Digestive System

    Addition of new listing:
    We propose to add a new listing, 5.09 Liver Transplant, in keeping 
with our other organ transplantation listings, e.g. heart transplant in 
listing 4.09 and kidney transplant in listing 6.02B.
    Removal of redundant or reference listings:
    We propose to remove several current listings because they are 
redundant. These four listings are all reference listings referring to 
listing 5.08:
     5.03--Stricture, stenosis, or obstruction of the esophagus 
with weight loss,
     5.04D--Peptic ulcer disease with weight loss,
     5.06E--Chronic ulcerative or granulomatous colitis with 
weight loss, and
     5.07D--Regional enteritis with weight loss.
    We propose to remove listing 5.05E because it is a reference 
listing to 12.02. We propose to add language to the preface in 5.00E to 
refer to the appropriate body system that may be affected by a 
digestive impairment.
    We propose to remove several listings or listing sections because 
there has been significant progress in medical technology and clinical 
experience related to the treatment of the digestive impairments that 
are contained in the current listings. Our program experience is that 
such advances in treatment mean that the criteria in some of the 
current listings are no longer appropriate indicators of listing-level 
severity. Many of these impairments can be controlled or resolved and 
thus are less likely to result in listing-level severity. Even if 
listing-level severity is initially present, the 12 month statutory 
duration requirement may no longer be met.
    We propose to remove current listing 5.04, Peptic ulcer disease 
(demonstrated by X-ray or endoscopy), due to progress in evaluation and 
treatment.
    Advances in medical and surgical management have made many 
complications from peptic ulcer disease such as recurrent ulceration 
(current listing 5.04A), fistula formation (current listing 5.04B) and 
recurrent obstruction (current listing 5.04C) less common. Treatment 
often results in significant improvement so that the criteria in these 
listings are no longer an appropriate indicator of listing-level 
severity. Therefore, we propose to remove all three current peptic 
ulcer disease listings.
    We also propose to remove several of the chronic liver disease 
listings, listing 5.05, due to progress in treatment and other reasons 
as described:
     5.05B--Chronic liver disease with performance of a shunt 
operation for esophageal varices. At the time this listing was written, 
only surgical shunts were available. Surgical shunts involve extensive 
abdominal surgery. They were not usually performed until your condition 
became serious enough to warrant undertaking the risks associated with 
prolonged surgery and anesthesia. Surgical shunts are now performed 
much less frequently. Clinical experience indicates that procedures 
such as the transjugular intrahepatic portal systemic shunt (TIPS), may 
be performed with minimal anesthesia and with fewer complications.
    TIPS represents an advance in the medical management of portal 
hypertension and massive ascites. Indications for a TIPS procedure 
include bleeding esophageal varices or refractory ascites.
     5.05C--Chronic liver disease with specific levels of serum 
bilirubin. Current listing 5.05C requires only a persistent elevated 
bilirubin level. We propose to delete this listing because a laboratory 
finding alone is not an accurate measure of your ability to function.
     5.05F--Chronic liver disease with liver biopsy. This 
listing requires confirmation of chronic liver disease by a liver 
biopsy, with a specified clinical or laboratory finding. We propose to 
delete this listing because it does not necessarily characterize an 
impairment of listing-level severity. A liver biopsy, while confirming 
the presence of liver disease, does not correlate with any specific 
level of impairment severity or decrease in functional ability. The 
biopsy only confirms what may have been discovered with imaging and 
other laboratory evidence. The specific laboratory values in the 
listing also are not an accurate measure of the severity and duration 
of the impairment. Proposed listing 5.05 will replace many of the 
criteria in current 5.05 to reflect more accurately listing-level 
impairments related to chronic liver disease.
    We also propose to remove current listing 5.06, Chronic ulcerative 
or

[[Page 57013]]

granulomatous colitis and current listing 5.07, Regional enteritis for 
the following reasons:
     5.06A--Chronic ulcerative or granulomatous colitis with 
recurrent bloody stools documented on repeated examinations and anemia 
manifested by hematocrit of 30 percent or less.
    Anemia, when caused by inflammatory bowel disease, is not an 
appropriate indicator of listing-level severity. Hematocrit level does 
not necessarily correlate with ability to function. A gradual reduction 
in hemoglobin, even to very low levels, is often well tolerated if you 
have normal cardiovascular and pulmonary systems.
     5.06B and 5.07B--Persistent or recurrent systemic 
manifestations, such as arthritis, iritis, fever or liver dysfunction 
due to chronic ulcerative or granulomatous colitis or regional 
enteritis. These listings required only the presence of a systemic 
manifestation in another body system or organ, without regard to degree 
of severity of functional impact. These listings are not an appropriate 
indicator of listing-level severity.
     5.06C and 5.07C--Intermittent obstruction due to 
intractable abscess, fistula formation or stenosis. Advances in 
surgical treatment have improved the management of these conditions, so 
that these listings are no longer an appropriate indicator of listing-
level severity.
     5.06D--Recurrence of findings of A, B, or C after total 
colectomy. We are proposing to remove this listing consistent with our 
proposal to remove listings 5.06A, B, and C.
    We propose to combine the remainder of listings 5.06--Chronic 
ulcerative or granulomatous colitis, and 5.07--Regional enteritis, into 
one listing for inflammatory bowel disease (IBD) (proposed listing 
5.06). IBD includes both ulcerative colitis and Crohn's disease. 
Crohn's disease includes regional enteritis. Crohn's disease may 
involve the entire gastrointestinal tract, but usually involves the 
small intestine or colon.
    We also propose to remove current listing 5.08B, Weight loss due to 
any persisting gastrointestinal disorder, with weight equal to or less 
than the values specified in Table III or IV and one of the listed 
abnormal laboratory findings present on repeated examinations. This 
listing allowed a lesser level of weight loss than that required to 
meet listing 5.08A when accompanied by one of the additional listed 
findings. Those findings, however, do not correlate with any specific 
level of impairment severity or decrease of functional ability that 
would be an accurate indicator of listing-level severity.
    The following is a detailed explanation of the proposed listing 
criteria.

Proposed Listing 5.02--Recurrent Gastrointestinal Hemorrhage

    We propose to revise the severity criteria in this listing from 
anemia with a hematocrit level of 30 percent or less, to the 
requirement for at least 2 units of blood transfused per episode, with 
hemorrhages occurring at least three times during a consecutive six-
month interval. A hematocrit level is not an appropriate indicator of 
the severity of gastrointestinal hemorrhage. It is the frequent 
recurrence of the hemorrhages and the cumulative effect on you that 
results in your inability to perform any gainful activity. We also 
propose to revise the source of gastrointestinal bleeding covered by 
this listing from ``upper gastrointestinal hemorrhage from undetermined 
cause'' to ``gastrointestinal hemorrhage from any cause.''
    Since improvements in medical treatment may resolve the frequency 
of hemorrhages and thus the overall severity of the impairment, we 
propose that you may be considered to be under a disability for one 
year following the last documented hemorrhage. Thereafter, we will 
evaluate your residual impairment(s).

Proposed Listing 5.05--Chronic Liver Disease

    We propose to replace current listing 5.05 with criteria that more 
accurately reflect listing-level severity.
    We propose to remove ``portal, postnecrotic, or biliary cirrhosis'' 
in the current listing 5.05 and replace it with ``cirrhosis of any 
kind.'' We listed these kinds of cirrhosis as examples of chronic liver 
disease, but we did not intend that we must specify the kind of 
cirrhosis present. Removing the examples would clarify our intent. We 
also propose to remove ``Wilson's disease'' and ``chronic active 
hepatitis'' from the examples of chronic liver disease because hepatic 
impairment due to Wilson's disease and chronic active hepatitis is 
included in the revised term ``cirrhosis of any kind.''
    We propose to revise listing 5.05A, esophageal varices, by defining 
our criteria for a massive hemorrhage. By providing a specific 
transfusion requirement, we intend to exclude minor variceal bleeding 
which would not be an indicator of listing-level severity.
    Newer techniques in primary prevention and treatment of esophageal 
varices, e.g., TIPS, banding, and sclerotherapy, have significantly 
improved the management of varices. Based on these advances, it is no 
longer appropriate to establish disability for 3 years as under current 
listing 5.05A, so we propose that you will be considered under a 
disability for one year following the last documented massive 
hemorrhage. Thereafter, we will evaluate your residual impairment(s).
    We are proposing to change current listing 5.05D, ascites due to 
chronic liver disease, to 5.05B. We propose to clarify how the 
persistence of the ascites over 6 months must be demonstrated. We are 
revising the required time interval from 5 months of ascites to 6 
months of ascites to be consistent with the other proposed digestive 
system listings. In our experience, requiring 6 months of persistent 
findings enables us to make a more reliable prediction of listing-level 
severity. We also require that evaluations be done at least two months 
apart within the six-month period to substantiate the chronic nature of 
the impairment, and to ensure that we are evaluating separate episodes.
    The presence of sufficient ascitic fluid requiring frequent 
paracentesis indicates disease of listing-level severity. Under current 
listing 5.05D, if paracentesis was not performed, ascites sufficient to 
be detected on physical examination, along with hypoalbuminimia would 
fulfill these criteria. However, current imaging techniques are capable 
of identifying even minimal amounts of ascites before they could be 
detected on physical examination, which would not be an indicator of 
listing-level severity liver disease. We explain this in the preface.
    If ascites is documented by medically acceptable imaging rather 
than by paracentesis, we still require evidence to confirm that there 
is significant deterioration of liver function. Therefore, we propose 
in listing section 5.05B2 to require reduction of serum albumin to the 
level specified in the listing or prolongation of the prothrombin time 
as specified in the listing.

Proposed Listing 5.06--Inflammatory Bowel Disease

    We propose to combine portions of current listings 5.06 and 5.07 
into listing section 5.06. Ulcerative colitis, Crohn's disease, 
granulomatous colitis, and regional enteritis are now commonly referred 
to as ``Inflammatory bowel disease'' (IBD). Combining these listings is 
appropriate considering current medical practice. The listing-level 
criteria for IBD concern persistent or recurrent intestinal 
obstruction. These criteria reiterate current listing 5.07A.

[[Page 57014]]

and also clarify that the intestinal obstruction must be documented by 
appropriate medically acceptable imaging, or operative findings. We 
propose the additional requirement that two episodes of obstruction 
over a consecutive 6-month period despite prescribed therapy be 
documented in order to ensure that this is a chronic impairment that 
will meet the 12-month duration requirement, rather than a single 
occurrence that can be successfully treated.

Proposed Listing 5.08--Weight Loss Due to Any Persisting 
Gastrointestinal Disorder

    We propose that the weight level demonstrating listing-level 
severity be documented for at least 6 consecutive months, despite 
prescribed therapy and expected to persist at this level for at least 
12 months, in order to ensure the continuing nature of the impairment. 
Weight loss of shorter duration may respond to treatment, and therefore 
may not be expected to persist for 12 months. Since these listings were 
originally written, there have been significant advances in the 
treatment of many digestive disorders, which have resulted in more 
favorable prognoses with treatment. However, it may take up to 6 months 
to determine whether treatment will lead to long-term improvement and 
possibly recovery, or just result in a temporary remission of 
impairment severity. In light of the current medical knowledge, we 
believe that 6 months is the minimum amount of time needed to determine 
that the weight loss due to a digestive impairment will continue at 
listing-level severity for long enough to fulfill the duration 
requirement of 12 months. This is consistent with the changes we 
propose in the other digestive listings.
    We also propose to update the weights listed in Tables I and II of 
listing 5.08. While we are proposing to adopt the use of Body Mass 
Index (BMI) in evaluating malnutrition in children (listing 105.08), we 
are not, at this time, proposing to adopt BMI to evaluate weight loss 
in adults. The Centers for Disease Control and Prevention (CDC) state 
that BMI is used differently with children than it is with adults. ``* 
* * Body Mass Index, or BMI (wt/ht\2\) provides a guideline based on 
weight and height to determine underweight and overweight. As children 
grow, their body fatness changes over the years. The interpretation of 
BMI depends on the child's age. Additionally, girls and boys differ in 
their body fatness as they mature. Therefore, we plot the BMI-for-age 
according to sex-specific charts.'' The CDC has prepared charts and 
tables that calculate BMI values for selected heights and weights for 
you from ages 2 to 20 years. The CDC has further determined that a BMI-
for-age 5th percentile meets their criteria for underweight. The CDC 
does not calculate a figure nor indicate a cutoff that is judged to be 
indicative of malnutrition.
    The current listings are based on standard growth charts to satisfy 
the listing for malnutrition. Current listing 105.08 requires (in 
part): ``Malnutrition, due to a demonstrable gastrointestinal disease 
causing either a fall of 15 percentiles of weight which persists or the 
persistence of weight which is less than the third percentile (on 
standard growth charts).
    The 3rd percentile is generally accepted as the lower limit of the 
normal range for most biologic measurements. Persistence below this 
level would warrant evaluation and, if available, intervention. Since 
the new BMI-for-age charts continue to provide percentiles, we are able 
to continue our policy of measurements below the 3rd percentile 
determined to correspond with listing-level severity for children.
    In assessing weight loss in adults, we have never used percentiles 
based on age calculations. Our current listing 5.08 is based on the 
Metropolitan Life Insurance Company's weight chart for medium frame 
individuals. The weights in tables 1 and 2 of listing 5.08 represent a 
20% reduction in the beginning weight for medium frame individuals as 
reflected in the weight charts in effect at the time the listings were 
last revised.
    The CDC has no such BMI-for-age charts for adults. They do state 
that ``underweight'' in adults is indicated by a BMI less than 18.5; 
however, neither the CDC nor any other recognized authority known to us 
has determined a BMI for adults that would be consistent with listing-
level severity weight loss due to a gastrointestinal impairment. Until 
we have a scientific basis for changing the way we calculate listing-
level severity weight loss in adults, we determined it would be best to 
just update our tables 1 and 2 using the latest Metropolitan Life 
Insurance Company's weight chart, last updated in 1983.
    We also expanded the heights and weights in the tables to add the 
metric equivalents for assistance in adjudication.
    The weight loss tables in listing 5.08 include listing-level 
weights for men whose height is between 5 feet 1 inch and 6 feet 4 
inches, and for women whose height is between 4 feet 10 inches and 6 
feet 1 inch. If your height is outside these table values and you 
allege disability due to weight loss related to a digestive impairment, 
these tables cannot be applied to evaluate whether your impairment 
meets the listing. In this situation, we would review the evidence in 
file to determine if your condition medically equals the listing. 
Considering the table weights and your weight, we would make a severity 
judgment. If you have a severe impairment that does not meet nor equal 
the listings, we continue to evaluate your claim through the sequential 
evaluation process, which would require assessment of your residual 
functional capacity and, if necessary, consideration of vocational 
factors such as your age, education and past work experience.

Proposed Listing 5.09--Liver Transplant

     We propose that you should be considered under a disability for 12 
months following the surgery, due to the nature and course of recovery 
for this procedure. After that time, we will evaluate the residual 
impairment(s). This is consistent with our criteria for assessing other 
organ transplants, such as kidney and heart.

How Are We Proposing To Change the Preface To the Listings for 
Evaluating Digestive Impairments in Children?

105.00  Digestive System

    As we already discussed in the explanation of 5.00 in the adult 
rules, we propose to revise the preface to provide additional guidance 
for adjudicating digestive impairments. Where necessary, we added 
information specific to the childhood listings; however, we repeated 
much of the proposed preface 5.00 in the proposed preface 105.00. This 
is because the same basic rules for establishing and evaluating the 
existence and severity of digestive impairments in adults also apply to 
children.
    Proposed 105.00A through 105.00F correspond to proposed 5.00A 
through 5.00F in the adult rules. Because we already described these 
provisions under the explanation of proposed 5.00, the following 
discussions describe only those provisions that are unique to the 
childhood rules or that require further explanation.

Proposed 105.00A--What Kind of Impairments Do We Consider in the 
Digestive System?

    This section contains the information in current 105.00A, and 
information from the last sentence in current 105.00C. It differs from 
the corresponding 5.00A in the proposed adult rules in the following 
ways:

[[Page 57015]]

     We added a paragraph addressing congenital defects of the 
gastrointestinal organs; and
     We added ``growth and development'' to ``nutrition'', in 
the paragraph addressing surgical diversions of the intestinal tract, 
since these factors are relevant to the assessment of disability in 
children.

Proposed 105.00B--What Documentation Do We Need?

    This section contains the information in current 105.00B. We made 
editorial changes to refer to ``children'' rather than ``individuals'' 
and changes to reflect the sequential evaluation of disability for 
children. Aside from these changes, the only substantive difference 
between this section and the corresponding proposed section for adults 
is the addition of ``assessment(s) of growth and development'' to the 
list of types of evidence that we consider.

Proposed 105.00C--How Do We Evaluate Digestive Disorders Under 
Listings That Require Recurring or Persistent Findings?

    This is a new section. It differs from the corresponding proposed 
5.00C in the adult rules, only in that it references childhood listings 
105.05, 105.06, and 105.08, rather than adult listings.

Proposed 105.00D--How Do We Consider the Effects of Treatment?

    This is a new section that corresponds to the proposed adult 
section 5.00D.

Proposed 105.00E--How Do We Evaluate Impairments That Do Not Meet 
One of the Digestive Listings?

    This is a new section. It contains two subsections that do not 
appear in the proposed adult rules. Subsection 105.00E1b includes the 
information in current 105.00D about multiple anomalies and subsection 
105.00E1c contains an updated version of the information in the first 
two sentences of current 105.00C about digestive impairments and 
reduction in the rate of growth.
    We also explain how evaluation of your impairment(s) will continue 
through the sequential evaluation process. We added a sentence about 
functionally equaling the listings, with a cross-reference to the 
appropriate regulatory citation.

Proposed 105.00F--What Are Our Guidelines for Evaluating Specific 
Digestive Impairments?

    This section contains the information in the first two sentences of 
current 105.00C. The rest of the information in this section is new. It 
is divided into four subsections: Malnutrition, weight loss and growth 
retardation; Chronic liver disease; Esophageal stricture or stenosis; 
and Inflammatory bowel disease.
    In subsection 105.00F1a, we explain how to evaluate weight loss and 
growth retardation that result from malnutrition. We also list examples 
of laboratory findings that represent chronic nutritional deficiency. 
In the revised listing 105.08, we require a documented sign of chronic 
nutritional deficiency to confirm the existence of a gastrointestinal 
disease resulting in malnutrition. We do not include these specific 
findings in the listing language because the required laboratory 
finding(s) are not limited to one of these specific examples. We will 
also accept other medically acceptable laboratory findings that 
represent chronic nutritional deficiency.
    Since we also are proposing to revise listing 105.08 by using Body 
Mass Index (BMI) measurements, we added a discussion of these 
measurements in subsection 105.00F1b.
    The Centers for Disease Control and Prevention (CDC) state that BMI 
is used differently with children than it is with adults. ``* * * Body 
Mass Index, or BMI (wt/ht\2\) provides a guideline based on weight and 
height to determine underweight and overweight. As children grow, their 
body fatness changes over the years. The interpretation of BMI depends 
on the child's age. Additionally, girls and boys differ in their body 
fatness as they mature. Therefore, we plot the BMI-for-age according to 
sex-specific charts.'' The CDC has prepared charts and tables that 
calculate BMI values for selected heights and weights for you from ages 
2 to 20 years. The CDC has further determined that a BMI-for-age 5th 
percentile meets their criteria for underweight. The CDC does not 
calculate a figure nor indicate a cutoff that is judged to be 
indicative of malnutrition.
    The current listings are based on standard growth charts to satisfy 
the listing for malnutrition. Current listing 105.08 requires (in 
part): ``Malnutrition, due to a demonstrable gastrointestinal disease 
causing either a fall of 15 percentiles of weight which persists or the 
persistence of weight which is less than the third percentile (on 
standard growth charts).
    The 3rd percentile is generally accepted as the lower limit of the 
normal range for most biologic measurements. Persistence below this 
level would warrant evaluation and, if available, intervention. Since 
the new BMI-for-age charts continue to provide percentiles, we are able 
to continue our policy of measurements below the 3rd percentile 
determined to correspond with listing-level severity for children.
    The new subsection on chronic liver disease, section 105.00F2, 
corresponds to the information in the proposed adult rules, except that 
we also added a discussion on portal hypertension in proposed 105.00F2C 
because chronic liver disease in children often presents as 
complications of portal hypertension.
    Section 105.00F3 addresses esophageal stricture or stenosis. This 
new preface section gives guidance in adjudicating this impairment when 
the malnutrition listing is not met.
    Section 105.00F4 discusses the documentation of an intractable 
perineal or intra-abdominal complication, such as intractable fecal 
incontinence.

How Are We Proposing To Change the Criteria in the Listings for 
Evaluating Digestive Impairments in Children?

105.00  Category of Impairments, Digestive System

    Addition of new listing:
    As in the proposed adult rules, we propose to add a new listing for 
children to address liver transplantation. The new listing will be 
105.09, liver transplant.
    Removal of redundant or reference listings:
    We propose to remove these listings because they refer to listing 
105.08:
     105.03--Esophageal obstruction, caused by atresia, 
stricture or stenosis, and
     105.07B--Chronic inflammatory bowel disease with 
malnutrition.
    These listings are met only when listing 105.08--Malnutrition, due 
to demonstrable gastrointestinal disease, is met. As we noted above, we 
are proposing to remove reference listings because they are redundant.
    We also propose to remove these other reference listings:
     105.05E--Chronic liver disease with hepatic 
encephalopathy. This reference listing directs us to evaluate the 
impairment under the criteria in 112.02--Organic mental disorders. 
Hepatic encephalopathy is addressed in proposed section 105.00E1a of 
the preface, which states that the impairment should be assessed under 
the criteria for the appropriate mental disorder or neurological 
listing.
     105.07C--Chronic inflammatory bowel disease, with growth 
impairment as described under the criteria in 100.03. This listing 
refers us to the criteria in listing 100.03--Growth impairment. We 
propose to add material

[[Page 57016]]

to the preface in 105.00E1c and 105.00F1a to address assessment of 
these impairment manifestations.
    As in the proposed adult rules, we propose to remove several 
listings or listing sections since there has been significant progress 
in medical technology and clinical experience related to the treatment 
of digestive impairments. Our program experience shows that because of 
these advances the criteria in some of the current listings can no 
longer be considered to result in marked and severe functional 
limitations. Even if listing-level severity is initially present, the 
statutory duration requirement may no longer be met.
    We propose to remove the following chronic liver disease listings:
     105.05A.--Chronic liver disease with inoperable biliary 
atresia. Children with this impairment often receive transplants and 
they would be evaluated under the proposed new listing 105.09--liver 
transplant. Otherwise, manifestations of this disease would be 
evaluated under the other liver disease listings.
     105.05D.--Chronic liver disease with hepatic coma. Hepatic 
coma, like hepatic encephalopathy, will now be assessed under the 
criteria for the appropriate mental or neurological listings.
     105.05F.--Chronic liver disease with chronic active 
inflammation or necrosis documented by SGOT persistently more than 100 
units or serum bilirubin of 2.5 mg. percent or greater. We propose to 
remove this listing because it requires only a persistent laboratory 
finding. Based on our program experience, a laboratory finding alone is 
not an accurate measure of the severity or duration of the impairment.
    The following is a detailed explanation of the proposed listing 
criteria.

Proposed Listing 105.05--Chronic Liver Disease

    We propose to add ``cirrhosis of any kind,'' for consistency with 
the proposed adult rules.
    We propose to revise current listing 105.05C.--Chronic liver 
disease with esophageal varices, and renumber it as proposed listing 
105.05A. We have added the requirement for bleeding attributable to the 
varices because the mere presence of esophageal varices, by itself, 
does not necessarily result in marked and severe functional 
limitations. As in the proposed adult listings, we have provided a 
specific transfusion requirement to exclude minor variceal bleeding 
which is not an indicator of listing-level severity. The transfusion 
requirement for children is based on frequency of needed transfusions, 
rather than amount of blood transfused, because in children, blood 
transfusions are only administered in cases of extreme need and the 
amount of blood transfused is variable depending on body size.
    We propose to revise current listing 105.05B--Chronic liver disease 
with intractable ascites, by removing the albumin level requirement. 
Persistent ascites related to chronic liver disease is an impairment of 
listing-level severity in children, regardless of serum albumin level.
    As explained in the preamble concerning the comparable adult 
listing, the presence of sufficient ascitic fluid requiring frequent 
paracentesis indicates disease of listing-level severity. However, 
current imaging techniques are capable of identifying even minimal 
amounts of ascites before they could be detected on physical 
examination, which would not be an indicator of listing-level severity 
liver disease; thus, in the absence of paracentesis, we require ascites 
to be documented on physical examination and by medically appropriate 
imaging techniques. We explain this in the preface.

Proposed Listing 105.06--Inflammatory Bowel Disease

    We propose to renumber current listing 105.07--Chronic inflammatory 
bowel disease, to proposed listing 105.06, for consistency with the 
corresponding proposed adult listing. We are revising and clarifying 
current 105.07A--Chronic inflammatory bowel disease with intestinal 
manifestations or complications, which becomes the only listing under 
proposed 105.06. We added the requirements for persistent or recurrent 
findings to ensure a frequency or duration of impairment consistent 
with listing-level severity. We also now require appropriate medically 
acceptable imaging evidence of the impairment. We are also adding a 
requirement for functionally limiting signs and symptoms that are 
characteristic of the impairment. Since inflammatory bowel disease can 
affect the entire digestive tract, we added an alternate subsection for 
perineal or intra-abdominal complications.

Proposed Listing 105.08--Malnutrition

    We propose to revise this section to be consistent with the new 
weight-for-length and Body Mass Index (BMI) measurements, growth charts 
and data file tables from the Centers for Disease Control and 
Prevention (CDC). On May 30, 2000, the CDC updated their 1977 weight-
for-length growth charts, and introduced BMI-for-age charts and tables. 
The CDC explains: ``* * * (BMI) is used to judge whether an 
individual's weight is appropriate for their height. * * * The new BMI 
growth charts can be used clinically beginning at 2 years of age, when 
an accurate stature can be obtained. These BMI-for-age charts were 
created for use in place of the 1977 weight-for-stature charts, as they 
are considered a more accurate tool.'' (NHANES (National Health & 
Nutrition Examination Survey) CDC Growth Charts: United States, The 
Revised Growth Charts, May 30, 2000. Both the weight-for-length and 
BMI-for-age charts and tables are available at http://www.cdc.gov/nchs/about/major/nhanes/growthcharts/background.htm.)
    We will prepare a Social Security Ruling containing instructions 
consistent with the CDC's BMI guidelines. It will be issued concurrent 
with publication of this material as a final rule.
    In children, the CDC defines ``Underweight'' as a BMI-for-age 5th 
percentile. However, neither the CDC nor any other recognized expert 
authority has published guidelines for the classification of 
malnutrition based on BMI. We will continue to investigate this area. 
In the meantime, we propose to continue to use our current criteria of 
persistence of weight for length or height below the third percentile 
to meet listing-level severity for malnutrition.
    Proposed Listing 105.09--Liver Transplant. We propose to add this 
new listing for children, consistent with the addition of listing 
5.09--Liver transplant in the proposed adult rules. We propose that you 
should be considered under a disability for 12 months following the 
surgery, due to the nature and course of recovery for this procedure. 
After that time, we will evaluate the residual impairment(s). This is 
consistent with our criteria for assessing other organ transplants, 
such as kidney transplant in listing 106.02D and heart transplant in 
listing 104.09.

Clarity of These Proposed Rules

    Executive Order 12866 requires each agency to write all rules in 
plain language. In addition to your substantive comments on these 
proposed rules, we invite your comments on how to make these proposed 
rules easier to understand.
    For example:
     Have we organized the material to suit your needs?
     Are the requirements in the rules clearly stated?

[[Page 57017]]

     Do the rules contain technical language or jargon that 
isn't clear?
     Would a different format (grouping and order of sections, 
use of headings, paragraphing) make the rules easier to understand?
     Would more (but shorter) sections be better?
     Could we improve clarity by adding tables, lists, or 
diagrams?
     What else could we do to make the rules easier to 
understand?

Regulatory Procedures

Executive Order (E.O.) 12866

    We have consulted with the Office of Management and Budget (OMB) 
and determined that these proposed rules meet the criteria for an 
economically significant regulatory action under E.O. 12866. They are 
also a ``major'' rule under 5 U.S.C. 801ff. The following is a 
discussion of the potential costs and benefits of this regulatory 
action. This assessment also contains an analysis of alternatives we 
considered and chose not to adopt.
    These proposed rules benefit society by updating the current 
listings to provide criteria that reflect state-of-the-art medical 
science and technology. The proposed rules ensure that determinations 
of disability have a sound medical basis, that claimants receive equal 
treatment through the use of specific criteria, and that people who are 
disabled can be readily identified and awarded benefits if all other 
factors of entitlement or eligibility are met.
    We are projecting savings in program expenditures as a result of 
these actions, described in more detail below.

Program Savings

1. Title II
    We estimate that, if finalized, these proposed rules would result 
in reduced program outlays resulting in the following savings (in 
millions of dollars) to the title II program ($295 million total in a 
5-year period beginning in FY 2003).

Fiscal year:
  2003.....................................................          -$5
  2004.....................................................         -$35
  2005.....................................................         -$60
  2006.....................................................         -$85
  2007.....................................................        -$110
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
      Total................................................    \1\ -$295
 

2. Title XVI
    We \1\ estimate that, if finalized, these proposed rules will 
result in reduced program outlays resulting in the following savings 
(in millions of dollars) to the SSI program ($85 million in a 5-year 
period beginning in FY 2003).
---------------------------------------------------------------------------

    \1\ 5-year total may not be equal to the sum of the annual 
totals due to rounding-out.

Fiscal year:
  2003.....................................................        -$2.5
  2004.....................................................         -$10
  2005.....................................................         -$20
  2006.....................................................         -$25
  2007.....................................................         -$30
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
      Total................................................     \2\ -$85
 

Program Costs

    We\2\ do not expect any program costs to result from these proposed 
regulations.
---------------------------------------------------------------------------

    \2\ Federal SSI payments due on October 1st in fiscal years 2006 
and 2007 are included with payments for the prior fiscal year.
---------------------------------------------------------------------------

Administrative Savings

    We do not expect any administrative savings to result from these 
proposed regulations.

Administrative Costs

    We expect that, if finalized, there will be some administrative 
costs associated with these proposed rules. If finalized, the proposed 
rules are expected to result in administrative costs less than 25 work 
years and less than $2 million per year.

Policy Alternatives

    We considered, but did not select, the following policy 
alternative:

Keep the current criteria with no or only minor technical changes

    We considered not revising the listings, or making only minor 
technical changes and thus, continuing to use our current criteria. 
However, we believe that proposing these revisions is preferable 
because of the medical advances that have been made in treating and 
evaluating these types of impairments. The current listings are now 
over 15 years old. Medical advances in disability evaluation and 
treatment and our program experience make clear that the current 
listings do not reflect state-of-the-art medical knowledge and 
technology.
    Since there would be no changes or only minor technical changes in 
using this alternative, the program and administrative costs would be 
the same as under the current rules. However, the program savings 
associated with the proposed rules would not be achieved.

Regulatory Flexibility Act

    We certify that these proposed rules would not have a significant 
economic impact on a substantial number of small entities because they 
would affect only individuals. Thus, a regulatory flexibility analysis 
as provided in the Regulatory Flexibility Act, as amended, is not 
required.

Paperwork Reduction Act

    These proposed rules contain reporting requirements at 5.00B, 
5.00D, 105.00B, and 105.00D. The public reporting burden is accounted 
for in the Information Collection Requests for the various forms that 
the public uses to submit the information to SSA. Consequently, a 1-
hour placeholder burden is being assigned to the specific reporting 
requirement(s) contained in these rules. We are seeking clearance of 
the burdens referenced in these rules because they were not considered 
during the clearance of the forms. An Information Collection Request 
has been submitted to OMB. We are soliciting comments on the burden 
estimate; the need for the information; its practical utility; ways to 
enhance its quality, utility and clarity; and on ways to minimize the 
burden on respondents, including the use of automated collection 
techniques or other forms of information technology. Comments should be 
submitted to the Social Security Administration at the following 
address: Social Security Administration, Attn: SSA Reports Clearance 
Officer, Rm. 1-A-20 Operations Building, 6401 Security Boulevard, 
Baltimore, MD 21235-6401. Comments can be received for between 30 and 
60 days after publication of this notice. Comments will be most useful 
if received by SSA within 30 days of publication.

(Catalog of Federal Domestic Assistance Program Nos. 96.001, Social 
Security-Disability Insurance; 96.002, Social Security-Retirement 
Insurance; 96.004, Social Security-Survivors Insurance; and 96.006, 
Supplemental Security Income)

List of Subjects in 20 CFR Part 404

    Administrative practice and procedure, Blind, Disability benefits, 
Old-Age, Survivors, and Disability Insurance, Reporting and 
recordkeeping requirements, Social Security.

    Dated: November 5, 2001.
Larry G. Massanari,
Acting Commissioner of Social Security.

    For the reasons set forth in the preamble, we propose to amend 
chapter III of title 20 of the Code of Federal Regulations as set forth 
below:

PART 404--FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE 
(1950-    )

    1. The authority citation for subpart P of part 404, continues to 
read as follows:

    Authority: Secs. 202, 205(a), (b), and (d)-(h), 216(i), 221(a) 
and (i), 222(c), 223, 225, and 702(a)(5) of the Social Security Act 
(42 U.S.C. 402, 405(a), (b), and (d)-(h), 416(i), 421(a) and (i), 
422(c), 423, 425, and

[[Page 57018]]

902(a)(5)); sec. 211(b), Pub. L. 104-193, 110 Stat. 2105, 2189.

    2. Item 6 of the introductory text before part A of appendix 1 is 
amended by revising the expiration date, as follows:

Appendix 1 to Subpart P of Part 404--Listing of Impairments

* * * * *
    6. Digestive System (5.00 and 105.00): [Insert date of 
publication of the final rules in the Federal Register.]
* * * * *
    3. Section 5.00 in part A and section 105.00 in part B of 
appendix 1 are revised to read as follows:
* * * * *

5.00 Digestive System

A. What Kind of Impairments Do We Consider in the Digestive System?

    1. Impairments of the digestive system include malnutrition, 
inflammatory bowel disease, hemorrhage, esophageal dysfunction, and 
hepatic (liver) dysfunction.
    2. Digestive disorders may also lead to complications (e.g., 
obstruction) or be accompanied by systemic manifestations in other 
body systems.
    3. Surgical diversion of the intestinal tract such as colostomy 
and ileostomy does not usually result in an inability to perform any 
gainful activity, as long as you are able to maintain adequate 
nutrition.
    4. Gastrointestinal impairments frequently respond to medical or 
surgical treatment and, therefore, the severity of these disorders 
should generally be considered within the context of prescribed 
treatment. This may be necessary in determining whether the duration 
requirement for disability will be met for cases in which you have 
not otherwise satisfied the duration requirement.

B. What Documentation Do We Need?

    1. When we assess gastrointestinal or liver impairments, we 
usually need longitudinal evidence covering a period of at least 6 
months of observations and treatment, unless we can make a fully 
favorable determination or decision without it. The evidence should 
include all available clinical and laboratory findings, including 
appropriate medically acceptable imaging studies, endoscopy, 
operative, and pathology reports. Criteria for documentation will be 
found in the individual listings.
    3. You may not have received ongoing treatment or have an 
ongoing relationship with the medical community, despite the 
existence of a severe impairment(s). We evaluate such cases on the 
basis of the objective medical evidence and other available 
evidence, taking into consideration all relevant factors including 
your medical history, symptoms, and medical source statements. Even 
though you may not be able to show an impairment that meets the 
criteria of one of the digestive listings, you may have an 
impairment(s) that medically equals the listings or may be found 
disabled based on consideration of your residual functional capacity 
(RFC) and age, education, and work experience.

C. How Do We Evaluate Digestive Disorders Under Listings That 
Require Recurring or Persistent Findings?

    1. Listings 5.02, 5.05, 5.06 and 5.08 require specific findings 
to be present on a recurring or persisting basis. Recurring means 
the longitudinal clinical record shows that the finding(s) satisfies 
the criteria in the listing as specified and that pattern has lasted 
or is expected to last for a continuous period of at least 12 
months. Persisting means the longitudinal clinical record shows 
that, with few exceptions, the finding(s) has been at, or is 
expected to be at, the level specified in the listing for a 
continuous period of at least 12 months.
    2. Events necessary to meet the listing (e.g., 3 events within a 
consecutive 6 month period) must occur within the period we are 
considering in connection with an application or continuing 
disability review. In every listing in which we require more than 
one event, there must be at least 1 month between the events (unless 
otherwise specified), to ensure that we are evaluating separate 
episodes.

D. How Do We Consider the Effects of Treatment?

    1. We assess the effect of treatment by determining if there is 
improvement in the signs, symptoms, and laboratory findings of the 
disorder, and if there are side effects that may result in 
functional limitations. We assess the effects of medication, 
therapy, surgery, or any other form of treatment you receive, when 
determining the severity and the duration of the impairment(s). The 
medical evidence should include:
    (a) a description of the treatment prescribed (e.g., the type of 
medication or therapy, the use of total parenteral nutrition (TPN) 
or enteral nutrition);
    (b) dosage, method, and frequency of administration;
    (c) your response to the treatment;
    (d) any adverse effects of such treatment;
    (e) the expected duration of the treatment.
    2. Because treatment itself or the effects of treatment may be 
temporary, in most cases sufficient time must elapse to allow us to 
evaluate the impact and expected duration of treatment and side 
effects. Where adverse effects of treatment contribute to the 
impairment severity, the duration or expected duration of the 
treatment must be considered in assessing the duration of the 
impairment(s).
    3. Nutritional therapy. The requirement for aggressive 
nutritional therapy, including parenteral or specialized enteral 
nutrition to avoid debilitating complications of a disease does not, 
in and of itself, indicate an inability to perform gainful activity, 
but should be considered, as any other treatment, in evaluation of 
the overall severity of the impairment.

E. How do we evaluate impairments that do not meet one of the 
digestive listings?

    1. These listings are only examples of common digestive 
impairments that we consider severe enough to prevent you from doing 
any gainful activity. If your impairment(s) does not meet the 
criteria of any of these listings, we must also consider whether you 
have an impairment(s) that satisfies the criteria of a listing in 
another body system. For example, when liver disease results in 
hepatic encephalopathy, we should evaluate the impairment(s) under 
the criteria for the appropriate mental disorder or neurological 
listing(s).
    2. If you have a medically determinable impairment(s) that does 
not meet a listing, we will determine whether your impairment(s) 
medically equals the listings. (SeeSecs. 404.1526 and 416.926.) If 
your impairment(s) does not meet or medically equal the listings, 
you may or may not have the RFC to engage in substantial gainful 
activity. In that situation, we proceed to the fourth, and if 
necessary, the fifth steps of the sequential evaluation process in 
Secs. 404.1520 and 416.920. When we decide whether you continue to 
be disabled, we use the rules in Secs. 404.1594 and 416.994, as 
appropriate.

F. What are our guidelines for evaluating specific digestive 
impairments?

    1. Malnutrition and weight loss. Gastrointestinal disease may 
result in malnutrition and weight loss. In addition to the 
impairments specifically mentioned in the listings, other 
gastrointestinal disorders such as stricture, stenosis or 
obstruction of the esophagus may result in significant weight loss. 
The resulting weight loss should be evaluated under the criteria of 
5.08. When using the tables in 5.08:
    (a) If the reported height measured in inches falls between the 
whole number values, the height should be rounded off to the nearest 
inch by whole number (e.g., if height is given as 62\1/4\ inches, 
round off to 62 inches). If the fraction is precisely one-half inch, 
the height should be rounded up to the nearest whole number (e.g., 
if height is given as 62\1/2\ inches, round up to 63 inches).
    (b) If the reported height measured in centimeters falls evenly 
between two table values (e.g., 151 cm falls evenly between 150 cm 
and 152 cm), the height should be rounded up to the nearest table 
value (e.g., 152 cm).
    (c) If the reported height measured in centimeters falls between 
two table values (e.g., 148 cm is between 147 cm and 150 cm), the 
height should be rounded off to the nearest table value (e.g., 147 
cm).
    2. Chronic liver disease is liver cell necrosis, inflammation, 
or scarring from any cause, that persists for more than 6 months, 
and is expected to continue for at least 12 months. Clinical 
manifestations may vary from an asymptomatic state to incapacitation 
due to liver failure. Acute hepatic injury is frequently reversible, 
as in viral, drug induced, and alcoholic hepatitis, and hepatic 
ischemia. In the absence of continuing evidence of a chronic 
impairment, episodes of acute liver disease do not necessarily meet 
the requirement for chronic liver disease.
    (a) Signs, and symptoms of chronic liver disease often include: 
jaundice (yellow appearance of the skin and mucous membranes), 
intractable pruritis (itching), ascites (accumulation of fluid in 
the abdominal cavity), lower extremity edema (swelling due to large 
amounts of fluid), gastrointestinal bleeding, fatigue, nausea,

[[Page 57019]]

change in mental status and loss of appetite. Laboratory findings in 
cases involving liver disease may include abnormalities of liver 
enzymes, decreased serum albumin, increased bilirubin, abnormal 
coagulation studies, and abnormal liver biopsy.
    (b) Liver disease may result in portal hypertension and 
esophageal varices, massive variceal hemorrhage, ascites, hepatic 
encephalopathy, and/or liver transplantation. We should assess 
impairment due to hepatic encephalopathy under the criteria for the 
appropriate mental disorder or neurological listing(s).
    (c) Massive hemorrhage from esophageal varices typically 
involves hematemesis (vomiting of blood), melena (passage of dark 
stools), or hematochezia (passage of bloody stools). You may be 
hemodynamically unstable as shown by signs and symptoms such as 
pallor (paleness), diaphoresis (profuse perspiration), postural 
hypotension (fall in blood pressure when standing), and syncope 
(fainting). The situation can be considered life-threatening with 
urgent need for multiple transfusions and other supportive care.
    (d) Liver function tests such as serum bilirubin or enzyme 
levels may correlate poorly with the clinical severity of liver 
disease, and must not be relied upon in isolation. Ascites, when 
associated with either albumin depletion or prolongation of the 
prothrombin time, usually indicates severe loss of liver function. 
Minimal ascites, as might be detected only by imaging techniques and 
not on physical examination, is not sufficient to meet the criteria 
in listing 5.05B.
    (e) Liver transplantation may be performed for progressive liver 
failure, life-threatening complications of liver disease, tumor or 
trauma. Disability is considered to last for one year from the date 
of transplant. After that time, we will evaluate the residual 
impairment(s), as outlined in paragraph (g) below.
    (f) When we use the phrase ``[c]onsider under a disability for 1 
year following'' a specific event, we are making a statement about 
the expected duration of disability, not about the onset of 
disability. We do not restrict the determination of the onset of 
disability to the date of the specified event. We can establish an 
earlier onset date if you are not engaging in substantial gainful 
activity (SGA) and the evidence in file supports the earlier onset 
date of disability.
    (g) After the one-year period following transplantation, we 
evaluate the effects of any residual impairment(s). Functional 
improvement after liver transplant depends upon various factors, 
including adequacy of post-transplant liver function, incidence and 
severity of infection, occurrence of rejection crisis(es), the 
presence of systemic complications and the side effects of immuno-
suppressive agents.

5.01  Category of Impairments, Digestive System

    5.02  Recurrent gastrointestinal hemorrhage from any cause, 
requiring at least two units of blood transfused per episode, and 
occurring at least three times during a consecutive 6-month period. 
(All incidents within a consecutive 14-day period constitute one 
episode.) Consider under a disability for 1 year following the last 
documented hemorrhage; thereafter, evaluate the residual 
impairment(s).

5.05  Chronic liver disease and cirrhosis of any kind, WITH:

    A. Esophageal varices demonstrated by x-ray, endoscopy, or other 
appropriate medically acceptable imaging, with massive hemorrhage 
attributed to varices which requires a transfusion of at least 5 
units of blood in 48 hours. Consider under a disability for 1 year 
following the last documented massive hemorrhage; thereafter, 
evaluate the residual impairment(s); OR
    B. Ascites persisting over a consecutive 6-month period despite 
prescribed treatment. The following findings must be demonstrated on 
at least two evaluations occurring at least 2 months apart within 
the 6-month period:
    1. Ascites documented by paracentesis; OR
    2. Ascites documented on physical examination and by appropriate 
medically acceptable imaging with:
    (a) an associated serum albumin of 3.0 gm/dl or less, or;
    (b) prolongation of the prothrombin time of at least 2 seconds 
over the control.
    5.06  Inflammatory bowel disease (e.g., ulcerative colitis, 
Crohn's disease) as documented by endoscopy, biopsy, appropriate 
medically acceptable imaging, or operative findings, with persistent 
or recurrent intestinal obstruction over a consecutive 6-month 
period, despite prescribed treatment, WITH:
    A. Confirmation, by appropriate medically acceptable imaging, of 
stenotic areas in small intestine or colon with proximal dilatation, 
and;
    B. Documentation of at least two episodes of abdominal pain, 
distention, and vomiting.
    5.08 Weight loss due to any persisting gastrointestinal 
disorder, with weight equal to or less than the values specified in 
Table I or II, persistent for at least 6 consecutive months despite 
prescribed treatment, and expected to persist at this level for at 
least 12 consecutive months.

                              Table I.--Men
------------------------------------------------------------------------
                  Height                               Weight
------------------------------------------------------------------------
            Inches/centimeters                    Pounds/kilograms
------------------------------------------------------------------------
61 in./155 cm.............................  103 lbs/47 kg
62 in./158 cm.............................  105 lbs/48 kg
63 in./160 cm.............................  106 lbs/48 kg
64 in./163 cm.............................  108 lbs/49 kg
65 in./165 cm.............................  110 lbs/50 kg
66 in./168 cm.............................  111 lbs/51 kg
67 in./170 cm.............................  114 lbs/52 kg
68 in./173 cm.............................  116 lbs/53 kg
69 in./175 cm.............................  118 lbs/54 kg
70 in./178 cm.............................  121 lbs/55 kg
71 in./180 cm.............................  123 lbs/56 kg
72 in./183 cm.............................  126 lbs/57 kg
73 in./185 cm.............................  128 lbs/58 kg
74 in./188 cm.............................  131 lbs/60 kg
75 in./191 cm.............................  134 lbs/61 kg
76 in./193 cm.............................  137 lbs/62 kg
------------------------------------------------------------------------


                            Table II.--Women
------------------------------------------------------------------------
                  Height                               Weight
------------------------------------------------------------------------
            Inches/centimeters                    Pounds/kilograms
------------------------------------------------------------------------
58 in./147 cm.............................  87 lbs/40 kg
59 in./150 cm.............................  89 lbs/40 kg
60 in./152 cm.............................  90 lbs/41 kg
61 in./155 cm.............................  92 lbs/42 kg
62 in./158 cm.............................  94 lbs/43 kg
63 in./160 cm.............................  97 lbs/44 kg
64 in./163 cm.............................  99 lbs/45 kg
65 in./165 cm.............................  102 lbs/46 kg
66 in./168 cm.............................  104 lbs/47 kg
67 in./170 cm.............................  106 lbs/48 kg
68 in./173 cm.............................  109 lbs/49 kg
69 in./175 cm.............................  111 lbs/50 kg
70 in./178 cm.............................  114 lbs/52 kg
71 in./180 cm.............................  116 lbs/53 kg
72 in./183 cm.............................  118 lbs/54 kg
73 in./185 cm.............................  121 lbs/55 kg
------------------------------------------------------------------------

    5.09  Liver transplant. Consider under a disability for 1 year 
following surgery. Thereafter, evaluate the residual impairment (see 
5.00F2e.)
* * * * *

Part B

* * * * *

105.00  DIGESTIVE SYSTEM

A. What kind of impairments do we consider in the digestive system?

    1. Impairments of the digestive system include malnutrition, 
inflammatory bowel disease, hemorrhage, esophageal dysfunction, and 
hepatic (liver) dysfunction.
    2. Digestive disorders may also lead to complications (e.g., 
obstruction) or be accompanied by systemic manifestations in other 
body systems.
    3. Congenital defects involving the organs of the 
gastrointestinal system may result in your inability to maintain 
adequate nutrition, growth and development.
    4. Surgical diversion of the intestinal tract such as colostomy 
and ileostomy does not usually result in marked and severe 
functional limitations, as long as you are able to maintain adequate 
nutrition, growth and development.
    5. Gastrointestinal impairments frequently respond to medical or 
surgical treatment, and, therefore, the severity of these disorders 
should generally be considered within the context of prescribed 
treatment. This may be necessary in determining whether the duration 
requirement for disability will be met for cases in which you have 
not already otherwise satisfied the duration requirement.

B. What documentation do we need?

    1. When we assess gastrointestinal or liver impairments, we 
usually need longitudinal evidence covering a period of at least 6 
months of observations and treatment, unless we can make a fully 
favorable determination or decision without it. The evidence should 
include all available clinical findings, including assessment(s) of 
growth and development, as well as all laboratory findings, 
including operative, appropriate medically acceptable imaging 
studies, endoscopy, and pathology reports. Criteria

[[Page 57020]]

for documentation will be found in the individual listings.
    2. You may not have received ongoing treatment or have an 
ongoing relationship with the medical community, despite the 
existence of a severe impairment(s). We evaluate such cases on the 
basis of the objective medical evidence and other available 
evidence, taking into consideration all relevant factors (see 
Secs. 416.924, 416.924a, and 416.924b) including your medical 
history, symptoms, and medical source statements. Even though you 
may not be able to show an impairment that meets the criteria of one 
of the digestive listings, you may have an impairment(s) medically 
equivalent in severity to one of the listed impairments or, as 
appropriate, may be disabled based on functionally equaling the 
listings (See Secs. 404.1526, 416.926, and 416.926a.).

C. How do we evaluate digestive disorders under listings that 
require recurring or persistent findings?

    1. Listings 105.05, 105.06 and 105.08 require specific findings 
to be present on a recurring or persisting basis. Recurring means 
the longitudinal clinical record shows that the finding(s) satisfies 
the criteria in the listing as specified and that pattern has lasted 
or is expected to last for a continuous period of at least 12 
months. Persisting means the longitudinal clinical record shows 
that, with few exceptions, the finding(s) has been at, or is 
expected to be at, the level specified in the listing for a 
continuous period of at least 12 months.
    2. Events necessary to meet the listing (e.g., 3 events within a 
consecutive 6-month period) must occur within the period we are 
considering in connection with an application or continuing 
disability review. In every listing in which we require more than 
one event, there must be at least 1 month between the events (unless 
otherwise specified), to ensure that we are evaluating separate 
episodes.

D. How do we consider the effects of treatment?

    1. We assess the effect of treatment by determining if there is 
improvement in the symptoms, signs, and laboratory findings of the 
disorder, and if there are side effects that may result in 
functional limitations. We assess the effects of medication, 
therapy, surgery, or any other form of treatment you receive, when 
determining the severity and the duration of the impairment(s). The 
medical evidence should include:
    (a) a description of the treatment prescribed (e.g., the type of 
medication or therapy, the use of total parenteral nutrition (TPN) 
or enteral nutrition);
    (b) dosage, method, and frequency of administration;
    (c) your response to the treatment;
    (d) any adverse effects of such treatment;
    (e) the expected duration of the treatment.
    2. Because treatment itself or the effects of treatment may be 
temporary, in most cases sufficient time must elapse to allow us to 
evaluate the impact and expected duration of treatment and side 
effects. Where adverse effects of treatment contribute to the 
impairment severity, the duration or expected duration of the 
treatment must be considered in assessing the duration of the 
impairment(s).
    3. Nutritional therapy. The requirement for aggressive 
nutritional therapy, including parenteral or specialized enteral 
nutrition to avoid debilitating complications of a disease does not, 
in and of itself, indicate marked and severe functional limitations, 
but should be considered, as any other treatment, in evaluation of 
the overall severity of the impairment.

E. How Do We Evaluate Impairments That Do Not Meet One of the 
Digestive Listings?

    1. These listings are only examples of common digestive 
impairments that we consider severe enough to result in marked and 
severe functional limitations. If your impairment(s) does not meet 
the criteria of any of these listings, we must also consider whether 
you have an impairment(s) that satisfies the criteria of a listing 
in another body system. For example:
    (a) When liver disease results in hepatic encephalopathy or 
hepatic coma, we should evaluate your impairment(s) under the 
criteria for the appropriate mental disorder or neurological 
listing(s).
    (b) If you have multiple congenital anomalies, you should be 
evaluated under the criteria for the multiple body system listings 
(section 110.00) or the criteria for other appropriate body 
system(s).
    (c) Digestive impairments that interfere with intake, digestion, 
and/or absorption of nutrition, may result in a reduction in the 
rate of growth. If such a reduction is not reflected in the 
malnutrition listing (105.08), it may be necessary to refer to the 
growth impairment listings for further evaluation of the impairment.
    2. If you haves a medically determinable impairment(s) that does 
not meet a listing, we will determine whether the impairment(s) 
medically equals the listings, or, in the case of a claim for SSI 
payments under Title XVI, functionally equals the listings. (See 
Secs. 404.1526, 416.926, and 416.926a.) When we decide whether you 
continue to be disabled under Title XVI, we use the rules in 
Sec. 416.994a.

F. What Are Our Guidelines For Evaluating Specific Digestive 
Impairments?

    1. Malnutrition, weight loss and growth retardation.
    (a) Chronic nutritional deficiency. Gastrointestinal disease may 
result in malnutrition. The resulting weight loss or growth 
retardation, or both, should be considered under the criteria of 
105.08 and, if necessary, section 100.00 (growth impairments) of the 
listings. To meet the criteria in 105.08, the malnutrition must be 
documented with a laboratory finding(s) confirming a chronic 
nutritional deficiency associated with a gastrointestinal 
impairment, which exists despite prescribed treatment. Such findings 
include, but are not limited to, the following:
    (1) Severe anemia (hemoglobin less than 8);
    (2) Serum albumin less than 3.0 Gm/Del;
    (3) Intractable steatorrhea, despite enzyme therapy, with fecal 
fat excretion more than:
    15% of fat intake in infants less than 6 months; OR
    10% of fat intake in infants 6-18 months; OR
    6% of fat intake in children more than 18 months of age.);
    (4) Vitamin, mineral, or trace mineral deficiency despite 
aggressive medical and nutritional therapy.
    (b) Body Mass Index (BMI). BMI is the ratio of your weight to 
the square of your height. According to the Centers for Disease 
Control and Prevention (CDC), it is the recommended measure to 
determine if your weight is appropriate for your height beginning at 
2 years of age. Prior to age 2, the CDC's weight-for-length charts 
should be used. A BMI-for-age less than the 5th percentile indicates 
underweight; a BMI-for-age less than the 3rd percentile satisfies 
our criteria for malnutrition when due to a demonstrable 
gastrointestinal or other impairment.
    2. Chronic liver disease is liver cell necrosis, inflammation, 
or scarring from any cause, that persists for more than 6 months, 
and is expected to continue for at least 12 months. Clinical 
manifestations may vary from an asymptomatic state to incapacitation 
due to liver failure. Acute hepatic injury is frequently reversible 
as in viral, drug-induced, and alcoholic hepatitis, and hepatic 
ischemia. In the absence of continuing evidence of a chronic 
impairment, episodes of acute liver disease do not necessarily meet 
the requirement for chronic liver disease.
    (a) Signs and symptoms of chronic liver disease often include: 
jaundice (yellow appearance of the skin and mucous membranes), 
intractable pruritis (itching), ascites, lower extremity edema 
(swelling due to large amounts of fluid), gastrointestinal bleeding, 
fatigue, nausea, change in mental status and loss of appetite. 
Laboratory findings in cases involving liver disease may include 
abnormalities of liver enzymes, decreased serum albumin, increased 
bilirubin, abnormal coagulation studies, and abnormal liver biopsy.
    (b) Liver disease may result in portal hypertension, bleeding 
from esophageal varices, ascites, hepatic encephalopathy, hepatic 
coma, and/or liver transplantation. We should assess impairment due 
to hepatic encephalopathy and hepatic coma under the criteria for 
the appropriate mental disorder or neurological listing(s).
    (c) Chronic liver disease in children may cause portal 
hypertension that precedes or seems out of proportion to the 
severity of hepatocellular injury. You may have chronic recurrent 
variceal bleeding, cholestasis (stoppage or suppression of the flow 
of bile), and/or ascites (accumulation of fluid in the abdominal 
cavity) well before other features of liver failure.
    (d) Massive hemorrhage from esophageal varices typically 
involves hematemesis (vomiting of blood), melena (passage of dark 
stools), or hematochezia (passage of bloody stools). You may be 
hemodynamically unstable as shown by signs and symptoms such as 
pallor (paleness), diaphoresis (profuse perspiration), postural 
hypotension (fall in blood pressure when standing), and syncope 
(fainting). The situation can be life-threatening with urgent need 
for multiple transfusions and other supportive care.
    (e) Liver function tests such as serum bilirubin or enzyme 
levels may correlate

[[Page 57021]]

poorly with the clinical severity of liver disease, and must not be 
relied upon in isolation. Ascites, when associated with either 
albumin depletion or prolongation of the prothrombin time, usually 
indicates severe loss of liver function. However, persistent ascites 
related to chronic liver disease is an impairment of listing-level 
severity in children, regardless of serum albumin level. Minimal 
ascites, as might be detected only by imaging techniques and not on 
physical examination, is not sufficient to meet the criteria in 
105.05B.
    (f) Liver transplantation may be performed for progressive liver 
failure, life-threatening complications of liver disease, tumor or 
trauma. Disability is considered to last for one year from the date 
of the transplant. After that time, we will evaluate your residual 
impairment(s), as outlined in paragraph (h) below.
    (g) When we use the phrase ``[c]onsider under a disability for 1 
year following'' a specific event, we are making a statement about 
the expected duration of disability, not about the onset of 
disability. We do not restrict the determination of disability onset 
to the date of the specified event. We can establish an earlier 
onset date if you are not engaging in substantial gainful activity 
(SGA) and the evidence in file supports the earlier onset date of 
disability.
    (h) After the one year period following transplantation, we 
evaluate the effects of any residual impairment(s). Functional 
improvement after liver transplant depends upon various factors, 
including adequacy of post-transplant liver function, incidence and 
severity of infection, occurrence of rejection crisis(es), the 
presence of systemic complications and the side effects of immuno-
suppressive agents. Growth and development may also be affected.
    3. Esophageal stricture or stenosis (narrowing) from congenital 
atresia (absence or closure of a normal body tubular organ) or 
destructive esophagitis may meet the criteria for malnutrition in 
listing 105.08. It also may result in complications that include 
respiratory impairments due to frequent aspiration, problems 
maintaining nutritional status short of listing-level severity, or 
multiple infections such as pneumonia. While none of these 
complications may be of a severity or persistence to meet the 
criteria of another specific listing, the combination may result in 
marked and severe functional limitations.
    4. Inflammatory bowel disease under listing 105.06B. requires an 
intractable perineal or intra-abdominal complication such as 
intractable fecal incontinence. Intractable is defined as resistant 
to cure, relief or control. There must be evidence of surgical or 
medical therapy that has failed to resolve the complication. Fecal 
incontinence involves passage of actual fecal material, not mere 
staining or spotting.

105.00  Category of Impairments, Digestive System

105.05  Chronic liver disease and cirrhosis of any kind

WITH:
    A. Esophageal varices demonstrated by x-ray, endoscopy, or other 
appropriate medically acceptable imaging, with at least three 
episodes of bleeding requiring transfusion due to hemodynamic 
instability, occurring over a consecutive 6-month period. Episodes 
must be separated by at least 1 month. Consider under a disability 
for 1 year following last episode; thereafter, evaluate the residual 
impairment(s); or
    B. Ascites persisting over a consecutive 6-month period despite 
prescribed treatment. The following findings must be demonstrated on 
at least two evaluations occurring at least 2 months apart within 
the 6-month period:
    1. Ascites documented by paracentesis; OR
    2. Ascites documented on physical examination and by appropriate 
medically acceptable imaging.
    105.06  Inflammatory bowel disease (e.g., ulcerative colitis, 
Crohn's disease) as documented by endoscopy, biopsy, appropriate 
medically acceptable imaging, or operative findings WITH:
    A. Persistent or recurrent intestinal obstruction over a 
consecutive six-month period, despite prescribed treatment, WITH:
    (1) Confirmation, by appropriate medically acceptable imaging, 
of stenotic areas in small intestine or colon with proximal 
dilatation, and;
    (2) documentation of at least two episodes of abdominal pain, 
distention, and vomiting; OR
    B. Perineal or intra-abdominal complications such as abscess, 
fistuli or fecal incontinence; intractable despite medical or 
surgical treatment; clinically documented over a consecutive 6-month 
period.
    105.08  Malnutrition, despite prescribed treatment, due to 
gastrointestinal, hepatobiliary, or pancreatic disease with a 
documented sign of chronic nutritional deficiency, meeting one of 
the following:
    A. For children under age 2, weight-for-length less than the 3rd 
percentile on the CDC's weight-for-length growth charts or data 
files, documented at least three times over a consecutive 6-month 
period, and expected to persist for at least 12 months; OR
    B. For children age 2 and over, Body Mass Index (BMI) for age 
less than the 3rd percentile on the CDC's BMI-for-age growth charts 
or data files, documented at least three times over a consecutive 6-
month period, and expected to persist for at least 12 months.
    105.09  Liver transplant. Consider under a disability for 1 year 
following surgery. Thereafter, evaluate the residual impairment(s) 
(see 105.00F2e.)
* * * * *
[FR Doc. 01-28455 Filed 11-13-01; 8:45 am]
BILLING CODE 4191-02-P