[Federal Register Volume 72, Number 202 (Friday, October 19, 2007)]
[Rules and Regulations]
[Pages 59398-59431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-20235]



[[Page 59397]]

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

Part III





Social Security Administration





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



20 CFR Parts 404 and 416



Revised Medical Criteria for Evaluating Digestive Disorders; Final Rule

  Federal Register / Vol. 72, No. 202 / Friday, October 19, 2007 / 
Rules and Regulations  

[[Page 59398]]


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

SOCIAL SECURITY ADMINISTRATION

20 CFR Parts 404 and 416

[Docket No. SSA 2006-0094]
RIN 0960-AF28


Revised Medical Criteria for Evaluating Digestive Disorders

AGENCY: Social Security Administration.

ACTION: Final rule.

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

SUMMARY: We are revising the criteria in the Listing of Impairments 
(the listings) that we use to evaluate claims involving digestive 
disorders. We apply these criteria when you claim benefits based on 
disability under title II and title XVI of the Social Security Act (the 
Act). The revisions reflect advances in medical knowledge, methods of 
evaluating digestive disorders, treatment, and our program experience. 
We are also removing listings that are redundant because they only 
refer to other listings, and we are making other conforming changes.

DATES: These rules are effective December 18, 2007.

FOR FURTHER INFORMATION CONTACT: James Julian, Director, Office of 
Medical Policy, Social Security Administration, 4470 Annex Building, 
6401 Security Boulevard, Baltimore, Maryland 21235-6401, 410-965-4015. 
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, Social Security Online, at http://www.socialsecurity.gov.

SUPPLEMENTARY INFORMATION:

Electronic Version

    The electronic file of this document is available on the date of 
publication in the Federal Register at http://www.gpoaccess.gov/fr/index.html.

Background

    We are revising and making final the rules we proposed in the 
Notice of Proposed Rulemaking (NPRM) published in the Federal Register 
on November 14, 2001 (66 FR 57009). We provide a summary of the 
provisions of the final rules below, with an explanation of the changes 
we have made from the text in the NPRM. We also provide summaries of 
the public comments and our reasons for adopting or not adopting the 
recommendations in these comments in the section, ``Public Comments.'' 
The final rule language follows the public comments.
    After we published the NPRM, we also:
     Published final rules on April 24, 2002, entitled 
Technical Revisions to Medical Criteria for Determinations of 
Disability (67 FR 20018). In those final rules, we added listings 5.09 
and 105.09 for liver transplantation. We also made minor technical 
changes to our listings to include references to modern imaging 
techniques. These final rules do not make substantive changes to the 
rules we published on April 24, 2002, although we are making minor 
editorial changes.
     Published a notice on November 8, 2004, providing a 60-day 
extension of the comment period on the NPRM for the limited purpose of 
accepting comments about the proposals regarding chronic liver disease 
(69 FR 64702). We explain this extension in more detail in the public 
comments section of this preamble.
     Held an outreach meeting in Cambridge, Massachusetts on 
November 17, 2004, regarding our listings for chronic liver disease. We 
describe this meeting in more detail in the public comments section of 
this preamble.

Why are we revising the listings for digestive disorders?

    We reviewed the prior digestive disorder listings and determined 
that they should be revised in light of our program experience and 
advances in medical knowledge, methods of evaluating digestive 
disorders, and treatment. We last published final rules comprehensively 
revising the digestive disorder listings in the Federal Register on 
December 6, 1985 (50 FR 50068). In the introductory text to those 
rules, we stated our intention to periodically review and update these 
listings due to medical advances in treatment and our program 
experience.

What do we mean by ``final rules'' and ``prior rules''?

    Even though these rules will not go into effect until 60 days after 
publication of this notice, for clarity we refer to the changes we are 
making here as the ``final rules'' and to the rules that will be 
changed by these final rules as the ``prior rules.''

When will we start to use these final rules?

    We will start to use these final rules on their effective date. We 
will continue to use our prior rules until the effective date of these 
final rules. When these final rules become effective, we will apply 
them to new applications filed on or after the effective date of these 
rules and to claims pending before us, as we describe below.
    As is our usual practice when we make changes to our regulations, 
we will apply these final rules on or after their effective date when 
we make a determination or decision, including those claims in which we 
make a determination or decision after a remand to us from a Federal 
court. With respect to claims in which we have made a final decision 
and that are pending judicial review in Federal court, we expect that 
the court would review the Commissioner's final decision in accordance 
with the rules in effect at the time the final decision of the 
Commissioner was issued. If a court reverses the Commissioner's final 
decision and remands the case for further administrative proceedings 
after the effective date of these final rules, we will apply the 
provisions of these final rules to the entire period at issue in the 
claim in our new decision issued pursuant to the court's remand.

How long will these rules be in effect?

    These rules will be in effect for 5 years after the date they 
become effective, unless we extend them or revise and issue them again.

What general changes are we making that affect both the adult and 
childhood listings for digestive disorders?

    We are clarifying the listing criteria and making them easier to 
use by:
     Removing reference listings and, when appropriate, 
providing guidance in the introductory text of the listings. Reference 
listings are listings that are met by satisfying the criteria of 
another listing. For example, an impairment could meet prior listing 
5.03, Stricture, stenosis, or obstruction of the esophagus, with weight 
loss ``as described under listing 5.08.'' Prior listing 5.08 required 
weight loss of a specific amount due to ``any persisting 
gastrointestinal disorder.'' Therefore, prior listing 5.03 was 
redundant because we could also evaluate weight loss from stricture, 
stenosis, or obstruction of the esophagus under listing 5.08 alone.
     Removing or updating outdated listings.
     Adding criteria to the listing for chronic liver diseases 
and expanding the guidance in the introductory text on how we evaluate 
these diseases, including specific guidance on chronic viral hepatitis 
infections.
     Revising and adding criteria to the listing for 
inflammatory bowel diseases and expanding the introductory text to 
include guidance on how we evaluate these digestive disorders.
     Adding a listing for short bowel syndrome and providing 
guidance in the introductory text for this disorder.

[[Page 59399]]

     Expanding the introductory text to include guidance on how 
we consider the effects of treatment.
     Providing general guidance in the introductory text 
explaining how we evaluate digestive disorders that do not meet these 
listings.
     Making nonsubstantive editorial changes to update the 
medical terminology in the listings and to be consistent with plain 
language guidelines.
    We discuss other changes in the listings below, in our detailed 
explanation of the revised listings.

How are we changing the introductory text to the listings for 
evaluating digestive disorders in adults?

5.00 Digestive System

    We are revising the introductory text for this body system to 
provide additional guidance for evaluating digestive disorders and to 
update its medical terminology. We are also removing references to 
digestive disorders and complications of digestive disorders, such as 
peptic ulcer disease, fistulae, and abscesses, that generally are not 
of listing-level severity. (However, as we explain below, we are 
including fistulae and abscesses as criteria in final listing 5.06 for 
inflammatory bowel disease.)
    We are including relevant material from prior 5.00A in final 5.00A 
and final 5.00C.
    We are updating and moving relevant material from prior 5.00B to 
final 5.00G.
    We are moving relevant material from prior 5.00C to final 5.00E. We 
are removing the portion of prior 5.00C that dealt with peptic ulcer 
disease because advances in diagnosis, evaluation, and treatment of 
this impairment make the surgical interventions discussed in the prior 
section (including gastrectomy, vagotomy, and pyloroplasty) much less 
common.
    Following is a detailed, section-by-section explanation of the 
final introductory text material.

5.00A--What kinds of disorders do we consider in the digestive system?

    This section revises prior 5.00A. We list the major types of 
digestive disorders included in these listings and provide an example 
of a complication that may result from them. In the NPRM, we proposed 
to include information in this section from prior 5.00C about colostomy 
and ileostomy. However, we moved this information to final 5.00E as 
part of the general reorganization of the introductory text. We also 
proposed to explain that gastrointestinal impairments frequently 
respond to treatment; therefore, their severity should be evaluated in 
the context of prescribed treatment. We moved this information to 
5.00C, ``How do we consider the effects of treatment?'' where it more 
logically fits.

5.00B--What documentation do we need?

    In this new section, we include examples of the types of clinical 
and laboratory findings that should be part of the longitudinal 
evidence. This section also includes two sentences describing 
appropriate medically acceptable imaging that were not in the NPRM, but 
that we added in the aforementioned final rules making technical, but 
not policy, changes to our listings. We revised the sentence describing 
medically acceptable imaging so that it more appropriately reflects 
imaging techniques used for digestive disorders. We also moved to this 
section a revised version of the first sentence of proposed 5.00C2, 
which explains that the specific findings required by these listings 
must occur within the period we are considering in connection with an 
individual's application or continuing disability review.
    In response to public comments we describe later in this preamble, 
we removed the sentence in proposed 5.00B1 explaining 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. Instead, we are providing 
timeframes for the evidence requirements in each listing.
    We moved proposed 5.00B2, which explained how we evaluate claims 
when an individual has not received ongoing treatment or does not have 
an ongoing relationship with the medical community despite the 
existence of a severe impairment, to final 5.00C where it fits more 
logically with our discussion of treatment issues.

5.00C--How do we consider the effects of treatment?

    In the NPRM, proposed 5.00C was titled, ``How do we evaluate 
digestive disorders that require recurring or persistent findings?'' 
Proposed 5.00C1 defined ``recurring'' and ``persisting'' as used in 
listings 5.02, 5.05, 5.06, and 5.08, and proposed 5.00C2 explained when 
the ``events'' required to satisfy the listings must occur. In these 
final rules, we removed the references to recurring or persistent 
findings from the digestive listings. We also moved the first sentence 
of 5.00C2 to final 5.00B. We no longer need the second sentence of 
proposed 5.00C2 because of changes we made to the listings. Therefore, 
we removed all of proposed 5.00C. We explain the reasons for the 
changes to the listings later in this preamble.
    We explain how we consider the effects of treatment in final 5.00C. 
This section is an expansion of proposed 5.00D. It includes six 
paragraphs that address treatment issues, rather than the three 
paragraphs we proposed. As we have already noted, we moved the 
additional paragraphs from other sections to present the information 
more logically.

General Information About Final 5.00D Through 5.00G

    In the NPRM, proposed 5.00F was titled ``What are our guidelines 
for evaluating specific digestive impairments?'' Proposed 5.00F1 
addressed malnutrition and weight loss, and proposed 5.00F2 addressed 
chronic liver disease. In these final rules, we are greatly expanding 
the introductory text from the NPRM in response to public comments and 
adding more discussion about digestive disorders, especially chronic 
liver disease and inflammatory bowel disease. Since we are including 
significantly more information in these final rules, we are addressing 
each kind of digestive disorder in its own separate section. Also, the 
guidance about specific disorders under proposed 5.00F was not in the 
order of the proposed listings. In the final rules, we are providing 
guidance that generally follows the structure of the final listings. 
Thus:
     Final 5.00D addresses chronic liver disease (final listing 
5.05);
     Final 5.00E addresses inflammatory bowel disease (final 
listing 5.06);
     Final 5.00F addresses short bowel syndrome (final listing 
5.07); and
     Final 5.00G addresses weight loss due to any digestive 
disorder (final listing 5.08).

5.00D--How do we evaluate chronic liver disease?

    In final 5.00D (proposed 5.00F2), we define chronic liver disease, 
provide examples of it, and describe its manifestations. In response to 
hundreds of public comments regarding hepatitis C, we are greatly 
expanding this section to explain how we evaluate chronic viral 
hepatitis, including chronic hepatitis B and C infections, and we 
describe extrahepatic manifestations of these infections. In addition, 
we include guidance for considering the effects of specific treatment 
modalities for hepatitis B and C infections. We also present 
information on conditions that we include in the chronic liver disease 
listing (that is, gastrointestinal

[[Page 59400]]

hemorrhage, ascites or hydrothorax, spontaneous bacterial peritonitis, 
hepatorenal syndrome, hepatopulmonary syndrome, hepatic encephalopathy, 
end stage liver disease, and liver transplantation).
    Final 5.00D contains 12 sections:
     Final 5.00D1, D2, and D3 are a reorganization of the 
information presented in proposed 5.00F2(a), F2(b), and F2(d).
     In final 5.00D1, we define chronic liver disease and name 
the manifestations of chronic liver disease that we consider under 
these listings. We removed the phrase in proposed 5.00F2 indicating 
that chronic liver disease must be ``expected to continue for 12 
months'' because it is unnecessary. Under our general rules for 
evaluating disability, an impairment must meet the duration 
requirement.
     We also removed the phrase in proposed 5.00F2d explaining 
that we would ``assess impairment due to hepatic encephalopathy under 
the criteria for the appropriate mental disorder or neurological 
listing(s).'' In response to public comments, we are adding a listing 
for hepatic encephalopathy (final listing 5.05F).
     Final 5.00D2 presents an expanded list of examples of 
chronic liver disease, including some diseases, such as Wilson's 
disease and chronic hepatitis, which we included in the heading of 
prior listing 5.05 but not in the heading of final listing 5.05.
     Final 5.00D3 is an expansion of proposed 5.00F2d. It has 
three paragraphs that describe the symptoms (5.00D3a), signs (5.00D3b), 
and laboratory findings (5.00D3c) associated with the manifestations of 
chronic liver disease.
    In response to a comment, we are including guidance in final 
5.00D3a to explain that symptoms may correlate poorly with the severity 
of chronic liver disease.
    In final 5.00D3c, we are clarifying our intent in proposed 5.00F2d, 
where we explained that abnormal liver function test findings may 
correlate poorly with the clinical severity of liver disease. Although 
that guidance is applicable to liver function tests such as serum total 
bilirubin or liver enzyme levels, it is not applicable to all tests 
indicative of liver function. In final 5.00D3c, we now explain that 
abnormally low serum albumin or elevated International Normalized Ratio 
(INR) levels are exceptions because they are indicators of significant 
liver disease. As we note below, we include criteria for abnormally low 
serum albumin and elevated INR in final listings 5.05B and 5.05F.
    We are also not including the statement from proposed 5.00F2d that 
liver function tests ``must not be relied upon in isolation'' because 
it is unnecessary. In final 5.00D3c, we are also expanding the rules 
from what we had proposed to include information on documenting chronic 
liver disease with a liver biopsy or imaging studies.
     Final 5.00D4 is new; there was no corresponding section in 
the NPRM. We added it in response to hundreds of comments concerning 
the growing incidence of hepatitis. In final 5.00D4a, we provide 
general information about chronic viral hepatitis infections. In final 
5.00D4b, we provide information about chronic hepatitis B infection. In 
final 5.00D4c, we provide detailed information about chronic hepatitis 
C infection, including a paragraph explaining adverse effects of 
treatment that may contribute to a finding of disability. In final 
5.00D4d, we provide information about the extrahepatic manifestations 
of hepatitis B and C infections that may result in, or contribute to, a 
finding of disability.
     Final 5.00D5 corresponds to proposed 5.00F2c. In it, we 
provide guidance for evaluating gastrointestinal hemorrhages under 
final listings 5.02 and 5.05A. As we explain in more detail below, we 
have revised proposed listings 5.02 and 5.05A in these final rules, and 
final 5.00D reflects the changes to the listings. For example, in 
response to comments, we expanded the scope of listing 5.05A to include 
hemorrhages from gastric or ectopic varices and portal hypertensive 
gastropathy in addition to hemorrhages from esophageal varices. Also in 
response to comments, we removed the proposed criterion for ``massive'' 
hemorrhage requiring transfusion of at least 5 units of blood in 48 
hours. Instead, final listing 5.05A requires hemorrhaging which results 
in ``hemodynamic instability,'' which we describe in final 5.00D5.
     In final 5.00D6, we provide guidance for evaluating 
ascites or hydrothorax under final listing 5.05B. In response to 
comments, we have revised proposed listing 5.05B; therefore, final 
5.00D6 reflects the changes we made to that listing. We explain those 
changes later in this preamble.
    We also removed the statement in proposed 5.00F2d that current 
imaging techniques are capable of identifying even minimal amounts of 
ascites before they can be detected on physical examination. We made 
this change because final listing 5.05B is met based on laboratory 
findings coupled with documentation of the ascites or hydrothorax. If 
these laboratory findings are at the level specified in the listing, it 
is not necessary to quantify the ascites.
     Final 5.00D7, D8, and D9 are also new in these final 
rules. In response to comments, we are including listing criteria in 
final listing 5.05 for three serious complications of chronic liver 
disease: Spontaneous bacterial peritonitis (final listing 5.05C); 
hepatorenal syndrome (final listing 5.05D); and hepatopulmonary 
syndrome (final listing 5.05E). Each new section explains how the 
condition is diagnosed and the documentation requirements for the new 
listings.
     In final 5.00D10, we provide guidance for evaluating 
hepatic encephalopathy under final listing 5.05F. As noted earlier, we 
added this listing in response to comments. In 5.00D10a, we explain how 
hepatic encephalopathy is diagnosed and identify the documentation 
requirements for the new listing. In final 5.00D10b, we explain that we 
will not evaluate acute encephalopathy under listing 5.05F if it 
results from conditions other than chronic liver disease.
     Final 5.00D11 is also new in these final rules. In 
response to public comments, we added listing 5.05G, for end stage 
liver disease (ESLD) with SSA Chronic Liver Disease (SSA CLD) scores of 
22 or greater. The SSA CLD calculation is a calculation we developed 
based on the Model for End Stage Liver Disease (MELD) calculation. The 
MELD is a numerical scale developed for the United Network for Organ 
Sharing (UNOS) that is used for liver allocation within the Organ 
Procurement and Transplantation Network. The MELD score is based on 
objective and verifiable medical data, and estimates an individual's 
risk of dying while waiting for a liver transplant. In final 5.00D11a, 
we explain that we will use the SSA CLD score to evaluate your end 
stage liver disease under final listing 5.05G. In final 5.00D11b-g, we 
explain how we calculate the SSA CLD score; for example, what 
laboratory values we use, when they must be obtained, and the formula 
we use to do the calculation.
     Final 5.00D12 corresponds to 5.00F2e and F2g in the NPRM. 
It explains how we evaluate liver transplantation 1 year after the date 
of the transplantation. The final rule is similar to the proposed rule; 
we edited it for clarity and expanded it slightly to provide more 
information about when liver transplantations are performed.

[[Page 59401]]

5.00E--How do we evaluate inflammatory bowel disease (IBD)?

    In response to public comments, we are greatly expanding the 
listing criteria for inflammatory bowel disease, final listing 5.06, 
and adding a new section, final 5.00E, to the introductory text to 
provide guidance for evaluating IBD under these expanded criteria.
    Final 5.00E contains four paragraphs:
     In final 5.00E1, we explain the general characteristics of 
IBD;
     In final 5.00E2, we list common symptoms, signs, and 
laboratory findings associated with IBD;
     In final 5.00E3, we describe some of the more common 
extraintestinal manifestations of IBD affecting different body systems; 
and
     In final 5.00E4, we explain how we consider surgical 
procedures such as ileostomy and colostomy. Final 5.00E4 corresponds to 
the first sentence of prior 5.00C and proposed 5.00A3.

5.00F--How do we evaluate short bowel syndrome (SBS)?

    In response to public comments, we are adding a new listing for 
short bowel syndrome, final listing 5.07, and a new section in the 
introductory text, final 5.00F, to provide guidance for evaluating SBS 
under this listing.

5.00G--How do we evaluate weight loss due to any digestive disorder?

    Final 5.00G corresponds to prior 5.00B and proposed 5.00F1 and 
reflects changes we made to proposed listing 5.08, discussed below. We 
are simplifying the guidance from prior 5.00B about evaluating 
malnutrition and weight loss. Under the final rules, it is sufficient 
for our purposes that the weight loss result from any medically 
determinable digestive disorder. We are also revising the heading of 
final 5.00G to refer only to weight loss, instead of the proposed 
reference to malnutrition and weight loss, to better reflect the 
content of the section.
    We revised proposed listing 5.08 to use Body Mass Index (BMI) to 
evaluate weight loss instead of using height and weight measurements by 
gender. BMI is the measurement recommended by the Centers for Disease 
Control and Prevention (CDC) to determine appropriate weight for 
height. In final 5.00G1, we explain that we use BMI to evaluate weight 
loss due to any digestive disorder under listing 5.08 and to evaluate 
lesser weight loss from IBD under listing 5.06B. The latter is one of 
the new criteria that we added to the IBD listing in response to public 
comments.
    In final 5.00G2, we explain how we calculate BMI. The change from 
height and weight measurements to BMI removed the need to provide rules 
for rounding of height and weight measurements; therefore, we do not 
include in these final rules the rules for rounding that were in 
proposed 5.00F1a-F1c.

5.00H--What do we mean by the phrase ``consider under a disability for 
1 year''?

    Final 5.00H corresponds to proposed 5.00F2f; however, we revised it 
to make clear that the phrase refers to the date on which we must 
determine whether an impairment continues to meet a listing or is 
otherwise disabling, not the date on which disability began. We explain 
that we do not restrict our finding about the onset date of disability 
to the date of a specific qualifying event in a listing, such as a 
liver transplant. For example, many individuals who need liver 
transplants (final listing 5.09) have impairments that meet one of the 
criteria for chronic liver disease (final listing 5.05) before they 
have their liver transplants.
    In the proposed rules, we had inadvertently included the 
explanation of the phrase ``consider under a disability for 1 year'' 
under the heading for chronic liver disease; however, we also use the 
phrase in final listing 5.02 for gastrointestinal hemorrhaging from any 
cause. Therefore, in the final rules, we explain the phrase in a 
section that is independent of the discussion of chronic liver disease, 
and we identify the three listings to which it applies.
    In proposed 5.00F2f, we had also stated that the phrase was a 
``statement about the expected duration of disability.'' In reviewing 
that language, we realized that it could have been misunderstood to 
mean that we presume that an individual will no longer be disabled 
after 1 year. That was not our intent. Rather, we intended to indicate 
only that after 1 year the impairment would no longer meet the 
requirements of the particular listing that includes the criterion. The 
impairment may still be disabling at the end of the period because it 
may meet or medically equal another listing or result in a residual 
functional capacity that is consistent with a finding of disability. 
Also, when we consider whether an impairment continues to be disabling, 
we apply the medical improvement review standard in Sec. Sec.  404.1594 
and 416.994. For these reasons, we are not including the statement in 
these final rules.

5.00I--How do we evaluate impairments that do not meet one of the 
digestive disorder listings?

    Final 5.00I is generally the same as proposed 5.00E, except that we 
include hepatitis B or C that results in depression as an example of a 
digestive impairment we would evaluate in another body system, instead 
of the hepatic encephalopathy example we included in proposed 5.00E1. 
This example was no longer appropriate because we have a listing for 
hepatic encephalopathy (5.05F) in the final rules.

How are we changing the listings for evaluating digestive disorders in 
adults?

5.01 Category of Impairments, Digestive System

Removal of Redundant or Reference Listings
    We are removing four prior listings because they were reference 
listings and, therefore, were redundant. These four listings were met 
by referring to the requirements of prior 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.
    All of these impairments are still covered by final listing 5.08. 
Chronic ulcerative or granulomatous colitis and regional enteritis are 
also covered by final listing 5.06. We no longer mention them 
explicitly in these final rules because they have been replaced by the 
more encompassing term ``inflammatory bowel disease.''
    Prior listing 5.05E, hepatic encephalopathy, was also a reference 
listing, referring to listing 12.02. In the NPRM, we proposed to remove 
the listing and to add language in proposed sections 5.00E1 and 5.00F2b 
that reminded adjudicators to evaluate the impairment under the 
criteria for the appropriate mental disorder or neurological listing. 
However, in response to many public comments, we decided to remove the 
proposed guidance and to provide a new listing specifically for hepatic 
encephalopathy in the digestive listings, final listing 5.05F. 
Therefore, while we are still removing prior reference listing 5.05E, 
we are including a different listing for hepatic encephalopathy in 
these final rules.

[[Page 59402]]

    We are also removing the following prior listings because medical 
knowledge, methods of evaluating digestive disorders, advances in 
treatment, and our program experience indicate that they are no longer 
appropriate indicators of listing-level severity. There has been 
significant progress in the treatment of these digestive disorders. 
Many of these disorders can be controlled or resolved and thus are less 
likely to be of listing-level severity. Even if listing-level severity 
is initially present, the 12-month statutory duration requirement will 
often not be met.
     5.04--Peptic ulcer disease (demonstrated by endoscopy or 
other appropriate medically acceptable imaging). Advances in medical 
and surgical management have made less common many complications from 
peptic ulcer disease, such as recurrent ulceration (prior listing 
5.04A), fistula formation (prior listing 5.04B), and recurrent 
obstruction (prior listing 5.04C). Treatment often results in 
significant improvement, therefore the prior listing criteria for these 
impairments are no longer appropriate indicators of listing-level 
severity.
     5.05B--Chronic liver disease with performance of a shunt 
operation for esophageal varices. When we first published this listing, 
only surgical shunts involving extensive abdominal surgery were 
available. These surgeries were not usually performed until the chronic 
liver disease became serious enough to justify the risks associated 
with prolonged surgery and anesthesia. More recently, transjugular 
intrahepatic portosystemic shunts (TIPS), which are performed with 
minimal anesthesia and with fewer complications, have largely replaced 
abdominal surgical shunts in treating the complications of portal 
hypertension, such as bleeding gastroesophageal varices or refractory 
ascites. However, in the final listing for hepatic encephalopathy, 
final listing 5.05F, we are adding a criterion for a history of TIPS in 
combination with other findings that describe an impairment that is of 
listing-level severity.
     5.05C--Chronic liver disease with specific levels of serum 
total bilirubin. Prior listing 5.05C required only a persistently 
elevated serum total bilirubin level. We are removing this listing 
because this laboratory finding alone does not correlate sufficiently 
with the ability to function.
     5.05F--Chronic liver disease with liver biopsy. This 
listing required confirmation of chronic liver disease by a liver 
biopsy, with another specified clinical or laboratory finding. We are 
removing this listing because a liver biopsy, while confirming the 
presence of liver disease, does not correlate with any specific level 
of impairment severity or decrease in ability to function. We assess 
the clinical findings described in prior listings 5.05F1 and F3 in 
other final listings, and we are removing the requirement for elevated 
serum total bilirubin level in prior listing 5.05F2 because it does not 
sufficiently demonstrate impairment severity or correlate with the 
ability to function.
     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. These criteria alone 
were not appropriate indicators of listing-level severity. However, we 
have incorporated a criterion for anemia in final listing 5.06, the new 
listing for IBD that we added in response to public comments.
     5.06B and 5.07--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 or impact on functioning. Therefore, they were not 
appropriate indicators of listing-level severity. However, in response 
to public comments described below, we are including examples of 
significant extraintestinal manifestations in final 5.00E3 with 
instructions to our adjudicators to consider these manifestations when 
determining whether the individual has an impairment(s) that meets or 
medically equals another listing and when assessing residual functional 
capacity. The examples include arthritis, iritis, and other effects.
     5.06C and 5.07C--Intermittent obstruction due to 
intractable abscess, fistula formation, or stenosis as a result of 
chronic ulcerative or granulomatous colitis or regional enteritis. 
Advances in surgical treatment have improved the management of these 
disorders, thus these listings are no longer appropriate indicators of 
listing-level severity. However, in final listing 5.06B, we include 
intestinal obstruction, abscess, fistula, and stenosis as criteria that 
can satisfy the requirements of the listing.
     5.06D--Recurrence of findings in listing 5.06A, B, or C 
after total colectomy. We are removing this listing consistent with our 
removal of listings 5.06A, B, and C.
     5.08B--Weight loss due to any persisting digestive 
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, did not correlate with any specific level of impairment 
severity or decrease of ability to function that would be an accurate 
indicator of listing-level severity. However, in response to public 
comments, we are including a 10 percent weight loss from baseline as 
one of the criteria that can be used to meet final listing 5.06 for 
individuals who have IBD.
    The following is a detailed explanation of the final listings.

Listing 5.02--Gastrointestinal Hemorrhaging From Any Cause, Requiring 
Blood Transfusion

    We are expanding this listing to include ``gastrointestinal 
hemorrhage from any cause'' instead of the prior listing's ``upper 
gastrointestinal hemorrhage from undetermined cause.'' We are also 
revising the severity criterion in this listing from anemia with a 
persistent hematocrit level of 30 percent or less, to a requirement for 
gastrointestinal hemorrhages that require blood transfusions of at 
least 2 units of blood per transfusion, occurring at least three times, 
at least 30 days apart, during a consecutive 6-month period. A 
hematocrit level by itself is generally not an appropriate indicator of 
the severity of gastrointestinal hemorrhage, and as we have already 
noted, does not necessarily correlate with inability to function.
    In these final rules, we are clarifying the proposed rule to 
explain that an individual does not have to be hospitalized for 
transfusions under this listing. We did not indicate whether 
hospitalization was required in the proposed rule. Therefore, this is 
only an editorial change for clarity.
    The proposed listing indicated in a parenthetical statement that 
``[a]ll incidents [hemorrhages] within a consecutive 14-day period 
constitute one episode.'' In the final listing, we are revising this 
statement by removing references to ``incidents'' and ``episodes'' and 
instead simply using the word ``transfusions,'' since transfusions are 
the indicators of severity. Also, in response to a public comment, we 
are increasing the length of time between blood transfusions (described 
as ``episodes'' in the proposed rule) from 14 days to 30 days.

[[Page 59403]]

    Since improvements in medical treatment may resolve the frequency 
of hemorrhages and thus the overall severity of the impairment, we 
indicate that we will consider an individual to be under a disability 
for 1 year following the last documented transfusion. After that, we 
will evaluate the residual impairment(s).

Listing 5.05--Chronic Liver Disease

    We are replacing prior listing 5.05 with criteria that more 
accurately reflect listing-level severity.
     We are removing the parenthetical examples of chronic 
liver diseases from the heading of prior listing 5.05 because these 
references could have been misinterpreted to mean that we included only 
those specific conditions under the listing. However, in response to 
comments, we continue to use Wilson's disease and chronic hepatitis as 
examples of chronic liver diseases that are covered by final listing 
5.05 in final 5.00D2 of the introductory text. In a change from the 
NPRM, and in response to many comments, we are revising the heading of 
the listing to refer to ``chronic liver disease'' only. We removed 
``and cirrhosis of any kind'' from the heading because cirrhosis is a 
form of chronic liver disease.
     In final listing 5.05A, we are expanding the scope of 
prior and proposed listing 5.05A in response to comments to include 
hemorrhaging from esophageal, gastric, or ectopic varices, or from 
portal hypertensive gastropathy. The proposed listing required 
``massive'' hemorrhage requiring ``5 units of blood in 48 hours.'' In 
response to comments, we changed the requirement for ``massive'' 
hemorrhage to hemorrhaging that results in hemodynamic instability, and 
we changed the transfusion requirements from the proposed ``5 units of 
blood in 48 hours'' to ``at least 2 units of blood.'' We chose 2 units 
of blood because this is the minimum amount of blood that is usually 
transfused. We define ``hemodynamic instability'' in 5.00D5.
    Newer techniques in primary prevention and treatment of bleeding 
gastroesophageal varices, for example, TIPS, banding, sclerotherapy, 
and laser therapy, have significantly improved the management of 
bleeding varices. Based on these advances, it is no longer appropriate 
to presume disability for 3 years as under prior listing 5.05A. 
Therefore, the final listing (like the proposed listing) provides that 
we will consider an individual disabled for 1 year following the last 
documented transfusion. After that, we will evaluate the residual 
impairment(s).
    Final listing 5.05B corresponds to prior listing 5.05D, ascites due 
to chronic liver disease. In response to comments, we are also 
including hydrothorax in the listing because ascitic fluid can collect 
in the chest cavity and result in a very serious impairment. Therefore, 
we are including thoracentesis in the documentation requirements in 
final listing 5.05B1 because it provides a definitive diagnosis of 
hydrothorax, just as paracentesis provides a definitive diagnosis of 
ascites.
    As in the NPRM, we are revising the required time period in which 
the evaluations showing ascites or hydrothorax must occur from 5 months 
to 6 months because, in our experience, a 6-month period enables us to 
make a more reliable prediction of duration of an impairment of 
listing-level severity. We also are requiring that evaluations be done 
at least 60 days apart within the 6-month period to substantiate the 
chronic nature of the impairment.
    In response to public comments, final listing 5.05B2 now requires 
documentation of ascites or hydrothorax by physical examination or by 
appropriate medically acceptable imaging, but not both, as we proposed 
in the NPRM. However, if the ascites or hydrothorax is documented by 
physical examination or imaging rather than paracentesis or 
thoracentesis, we require additional laboratory findings that confirm 
very serious chronic liver disease. As in proposed listing 5.05B2a, we 
require serum albumin of 3.0 g/dL or less. In response to public 
comments, we changed the proposed criterion for a measure of 
prothrombin time to a criterion for an elevated International 
Normalized Ratio (INR) of at least 1.5 in final listing 5.05B2b. The 
public comments correctly indicated that INR is a more widely used 
study.
     In response to public comments, we are also adding three 
new listings for serious complications of chronic liver disease: Final 
listing 5.05C for spontaneous bacterial peritonitis; final listing 
5.05D for hepatorenal syndrome; and final listing 5.05E for 
hepatopulmonary syndrome. These complications are so severe that we 
require only one occurrence of any one of them, shown by the requisite 
findings, to satisfy the listing.
     As already noted, we are also adding a new listing 5.05F 
for hepatic encephalopathy. The new listing requires hepatic 
encephalopathy documented by abnormal behavior, cognitive dysfunction, 
changes in mental status, or altered state of consciousness, present on 
at least two evaluations at least 60 days apart within a consecutive 6-
month period, with associated physical signs or laboratory findings, 
occurring with the same frequency and during the same time period; or a 
history of a TIPS or any surgical portosystemic shunt procedure.
     In response to comments that individuals on liver 
transplant lists should qualify, we are adding another new listing, 
final listing 5.05G, for evaluating individuals with ESLD. We are using 
an SSA CLD score criterion as an objective means to measure listing-
level severity. As discussed above, we based the SSA CLD calculation on 
the MELD calculation used by UNOS to prioritize individuals ages 12 and 
over on a national liver transplantation list according to the severity 
of their liver disease. (There is also a Pediatric End Stage Liver 
Disease scoring system, called PELD, for children under age 12. We have 
developed an SSA Chronic Liver Disease--Pediatric (SSA CLD-P) 
calculation based on that system that we have included in the part B 
listings, as we explain below.) The SSA CLD score determination relies 
only on objective criteria, with standardized laboratory determinations 
that are readily available and reproducible.
    We did not agree that all individuals on transplant lists should 
qualify under our listings because the threshold criteria for placement 
on a transplant list vary widely throughout the country and some 
individuals are placed on transplantation lists well before they have 
listing-level impairments. In the final rule, we provide that a SSA CLD 
score of 22 or greater meets the listing. We chose this score based on 
the clinical severity represented by the laboratory values contained in 
the SSA CLD score.
    For final listing 5.05G, we require two calculations of SSA CLD 
scores, at least 60 days apart, and that the scores must be calculated 
within a consecutive 6-month period, consistent with other provisions 
in these final rules.

Listing 5.06--Inflammatory Bowel Disease

    We are combining portions of prior listings 5.06 and 5.07 into 
final listing 5.06. Ulcerative colitis, Crohn's disease, granulomatous 
colitis, and regional enteritis are now commonly referred to as 
``inflammatory bowel disease'' (IBD).
    In the NPRM, proposed listing 5.06 required documentation of IBD 
with persistent or recurrent intestinal obstruction. The proposed 
listing repeated the criteria from prior listing 5.07A, clarified that 
the intestinal obstruction must be documented by appropriate medically 
acceptable imaging or operative findings, and

[[Page 59404]]

included the requirement for documentation of two episodes of 
obstruction over a consecutive 6-month period despite prescribed 
treatment, to ensure that there is a chronic impairment.
    In response to public comments, we are significantly revising and 
expanding final listing 5.06. As in the proposed listing, the 
introductory paragraph of final listing 5.06 requires documentation of 
IBD by endoscopy, biopsy, appropriate medically acceptable imaging, or 
operative findings. As in the NPRM, final listing 5.06A requires 
obstruction of stenotic areas in the small intestine or colon with 
proximal dilatation. We are clarifying in the final rule that adhesions 
do not satisfy the requirement for obstruction. This is not a 
substantive change but a clearer statement of our intent that there 
must be obstruction that results from IBD. We are also clarifying that, 
in these cases, the stenotic areas may be shown by surgery or by 
medically acceptable imaging. In addition, we are clarifying the 
language we had proposed by requiring hospitalization for treatment of 
the obstruction (intestinal decompression or surgery). This is not a 
substantive change from the NPRM because listing-level obstruction of a 
stenotic area would require hospitalization for one of these types of 
treatment. Therefore, the requirement in the final listing will only 
help to confirm the existence of listing-level obstruction caused by 
IBD.
    We are deleting the proposed requirement for persistent or 
recurrent obstruction over a consecutive 6-month period despite 
prescribed treatment in response to a public comment. Instead, we are 
requiring that the findings occur on at least two distinct occasions at 
least 60 days apart within a consecutive 6-month period.
    Final listing 5.06B includes six other manifestations of IBD that 
were suggested by commenters. Consistent with most of the other 
criteria in the final rules for impairments that have episodic 
manifestations, final listing 5.06B requires that two of the six 
criteria be present on at least two evaluations, occurring at least 60 
days apart within the same consecutive 6-month period, except for 
listing 5.06B6, which requires supplemental daily enteral nutrition via 
a gastrostomy or daily parenteral nutrition via a central venous 
catheter.

Listing 5.07--Short Bowel Syndrome

    As we explained earlier, we are removing prior listing 5.07, for 
regional enteritis. Instead, we evaluate this condition under final 
listing 5.06, for IBD. However, in response to comments regarding 
individuals who need parenteral nutrition, we are adding a new listing, 
final listing 5.07, for short bowel syndrome to address situations in 
which post-operative nutritional needs cannot be met orally or with 
supplemental enteral nutrition. This final listing requires a diagnosis 
of short bowel syndrome due to surgical resection of more than one-half 
of the small intestine with resulting dependence on daily parenteral 
nutrition via a central venous catheter.

Listing 5.08--Weight Loss Due to Any Digestive Disorder

    In this final rule, we changed the heading of prior and proposed 
listing 5.08, ``Weight loss due to any persisting gastrointestinal 
disorder'' to ``Weight loss due to any digestive disorder.'' We deleted 
the word ``persisting'' for reasons we explain in the public comments 
section of this preamble.
    In final listing 5.08, we are establishing the severity of the 
weight loss based on the CDC's BMI formula, rather than the 
Metropolitan Life Insurance Company's weight charts we used in the 
proposed rules and which were last updated in 1983. When we published 
the NPRM in 2001, we indicated that neither the CDC nor any other 
recognized authority known to us had determined a BMI for adults that 
would be consistent with listing-level severity weight loss. However, 
since that time, we determined that we could establish a BMI comparable 
to the severity standard in the weight charts. We established this BMI 
level in the final listing by calculating the BMI for each value on 
proposed weight tables I and II and averaging them.
    We are changing to the more widely used BMI for several other 
reasons. For example, this change eliminates the need for gender 
tables, as BMI is not gender-specific in adults. Also, we were not able 
to apply the prior and proposed weight tables to individuals whose 
height was outside the table values, and instead had to review the 
evidence and determine whether the impairment medically equaled the 
listing. Now we can apply the BMI formula to all cases regardless of 
the individual's height. Also, our use of BMI in this body system is 
consistent with our use of BMI in Social Security Ruling 02-1p, Title 
II and XVI: Evaluation of Obesity (67 FR 57859).

Listing 5.09--Liver Transplantation

    In the NPRM, we proposed to add listing 5.09 for liver 
transplantation. However, we published final rules adding this listing 
on April 24, 2002 (67 FR 20018) based on another NPRM in which we had 
also proposed to add this listing. (See 65 FR 6934.) Therefore, in 
these final rules, we are retaining the listing we published in April 
2002, revising it to include the phrase ``1 year following the date of 
transplantation,'' and changing the punctuation to make it easier to 
read. The only public comments we received about this listing agreed 
that we should add it.

How are we changing the introductory text to the listings for 
evaluating digestive disorders in children?

105.00 Digestive System

    As in the adult rules, we are revising the introductory text to the 
digestive system in part B, final 105.00, to provide additional 
guidance for adjudicating digestive disorders. Where necessary, we are 
adding information specific to children; however, we are repeating much 
of the introductory text of final 5.00 in final 105.00. This is 
because, for the most part, the same basic rules for establishing and 
evaluating the existence and severity of digestive disorders in adults 
also apply to children. We are making a number of changes from the NPRM 
in the final rules to make part B even more consistent with part A than 
we originally proposed. As we note below, we are also adding:
     Listing 105.02 for gastrointestinal hemorrhaging from any 
cause requiring blood transfusion;
     Listing 105.05A for hemorrhaging from esophageal, gastric, 
or ectopic varices, or from portal hypertensive gastropathy;
     Listings 105.05C, D, and E for complications of chronic 
liver disease;
     Listing 105.05F for hepatic encephalopathy;
     Listing 105.05G for end stage liver disease with SSA CLD 
and SSA CLD-P score criteria;
     Listing 105.05H for extrahepatic biliary atresia;
     Listing 105.06 for inflammatory bowel disease;
     Listing 105.07 for short bowel syndrome; and
     Listing 105.10 for the need for supplemental daily enteral 
feeding via a gastrostomy.
    The following discussions describe only the significant provisions 
that are unique to the childhood rules or that require further 
explanation. We do not note differences like the fact that we use 
references to childhood listings instead of adult listings or that we 
use references to ``children'' instead of adults.

[[Page 59405]]

105.00A--What kinds of disorders do we consider in the digestive 
system?

    Final 105.00A corresponds to final 5.00A, except that we are adding 
information to explain that under the childhood listings we also 
consider congenital abnormalities involving the organs of the 
gastrointestinal system.

105.00B--What documentation do we need?

    The only substantive difference between final 105.00B and final 
5.00B is a statement noting that we may also need assessments of a 
child's growth and development.

105.00D--How do we evaluate chronic liver disease?

    The new guidance on chronic liver disease in final 105.00D 
generally corresponds to the information in final 5.00D in the adult 
rules, except for information specific to the complications of chronic 
liver disease in children and two sections (final 105.00D11b and 
105.00D12) that are not in part A because they provide guidance for 
listing criteria that are only in the final childhood rules.
    In final 105.00D11b, we provide information about the SSA Chronic 
Liver Disease--Pediatric (SSA CLD-P) calculation, which we use under 
final listing 105.05G2 for children who have not attained age 12. We 
explain in final 105.00D11b(iv) that we will not purchase the INR value 
required to calculate the SSA CLD-P score because obtaining the 
necessary amount of blood to perform this test in small children often 
requires an invasive procedure. We further explain that if we do not 
have an INR value for a child under 12 within the applicable time 
period, we will use an INR value of 1.1 for the SSA CLD-P calculation. 
(In final 105.00D11a, we provide the same guidelines about the SSA CLD 
calculation as we do in part A because the SSA CLD calculation is 
applicable to children age 12 to the attainment of age 18.)
    In final 105.00D12, we provide guidance for applying final listing 
105.05H for extrahepatic biliary atresia, a congenital disorder of the 
liver.

105.00E--How do we evaluate inflammatory bowel disease (IBD)?

    Final 105.00E corresponds to final 5.00E. In the NPRM, we proposed 
a short section (proposed 105.00F4) on IBD that provided guidance for 
evaluating IBD under proposed listing 105.06. As in final listing 5.06 
in part A, we have greatly expanded proposed listing 105.06 in these 
final rules, so we are also including the more detailed guidance for 
evaluating the expanded listing criteria of final listing 105.06 that 
we provide in part A for final listing 5.06.

105.00G--How do we evaluate malnutrition in children?

    Final 105.00G (proposed 105.00F1) reflects changes we made to final 
listing 105.08, Malnutrition due to any digestive disorder. In final 
105.00G1, we explain that digestive disorders may result in 
malnutrition and growth retardation. We also explain that we document 
the presence of a digestive disorder with associated chronic 
nutritional deficiency despite prescribed treatment using the 
malnutrition criteria in final listing 105.08A.
    The malnutrition criteria in final listing 105.08A generally 
correspond to the laboratory findings we presented as examples in the 
introductory text, proposed 105.00F1(a)(1), F1(a)(2), and F1(a)(4). We 
are including them as listing criteria in final listing 105.08A in 
response to a public comment.
    Final listing 105.08A1 corresponds to proposed 105.00F1(a)(1). 
However, we changed the criterion for anemia to a hemoglobin of less 
than 10.0 g/dL, rather than less than 8 g/dL, to be consistent with the 
anemia criteria elsewhere in these final listings. Final listing 
105.08A2 requires low serum albumin levels and corresponds to proposed 
105.00F1(a)(2). Final listing 105.08A3 corresponds to proposed 
105.00F1(a)(4), except that we added the phrase ``fat soluble'' to 
clarify the type of vitamin deficiency we intended. We also removed the 
concluding phrase ``despite aggressive medical and nutritional 
therapy'' because the introductory paragraph of the listing requires 
findings ``despite continuing treatment as prescribed.'' We did not 
include as a listing criterion the example of intractable steatorrhea 
(malabsorption of dietary fats) quantified by fecal fat excretion that 
we had included in proposed 105.00F1(a)(3); most pediatric laboratories 
no longer do this type of testing, and steatorrhea will usually result 
in the vitamin deficiency we describe in final listing 105.08A3.
    In 105.00F1b of the proposed rules, we included a paragraph 
discussing Body Mass Index (BMI) measurements. We explained in the 
preamble of the NPRM that we proposed to add this discussion because 
proposed listing 105.08 included criteria based on BMI measurements. 
(See 66 FR at 57015 and 57020.)
    We are not including this paragraph in the final rules because, 
when we reviewed it, we realized that it did not provide guidance that 
would have been useful to the application of final listing 105.08 and 
that it could have been confusing for the following reasons:
     As in the NPRM, final listing 105.08 includes two criteria 
for documenting growth retardation, one for children under age 2 (final 
listing 105.08B1) and one for children age 2 and older (final listing 
105.08B2). Only final listing 105.08B2 includes a criterion for BMI, 
and it refers to the CDC's latest BMI-for-age growth charts or data 
files. The language we included in proposed 105.00F1b did not explain 
this clearly.
     Furthermore, much of the language repeated what the 
listing already said, and we believe that the language that was not 
redundant of the listing was unnecessary. The first sentence defined in 
basic terms how to calculate a BMI; however, it was oversimplified for 
children.
     The proposed paragraph also referred to the fact that the 
CDC has determined that a BMI-for-age less than the fifth percentile 
meets its criteria for underweight. However, since the CDC does not 
calculate a figure or indicate a cutoff that it judges to be indicative 
of malnutrition, this guidance in the proposed rule would not have been 
useful for applying final listing 105.08.
    In final 105.00G2, which replaces proposed 105.00F1b, we are 
providing information that is more relevant to the application of final 
listing 105.08B. We explain that we use the most recent growth charts 
published by the CDC. In final 105.00G2a, we explain that we use the 
CDC's age- and gender-specific weight-for-length charts for children 
who have not attained age 2. In final 105.00G2b, we explain that we use 
the CDC's gender-specific BMI-for-age charts for children age 2 or 
older. In final 105.00G2c, we explain how we calculate BMI, and in 
final 105.00G2d we provide the corresponding BMI formulas. Final 
105.00G2c and 105.00G2d are the same as final 5.00G2a and 5.00G2b.

105.00H--How do we evaluate the need for supplemental daily enteral 
feedings via a gastrostomy?

    Final 105.00H is a new section that provides guidance for 
evaluating the need for feeding gastrostomies for children under age 3 
under final listing 105.10. We had previously provided for a finding of 
functional equivalence for children under age 3 who require a 
gastrostomy for feeding in Sec.  416.926a(m)(10). We are now making 
that example of functional equivalence a listing and removing the 
example from Sec.  416.926a(m).

[[Page 59406]]

105.00I--How do we evaluate esophageal stricture or stenosis?

    Final 105.00I corresponds to proposed 105.00F3 and includes minor 
editorial changes for clarity. In this section, we provide guidance for 
evaluating esophageal stricture or stenosis, which we had listed in 
prior listing 105.03, a listing we are removing because it is a 
reference listing. In the final rule, we explain that these conditions 
may be evaluated under listing 105.08 or 105.10. We also provide 
guidance for adjudicating these conditions when they do not meet a 
listing but the child still has problems maintaining nutritional 
status.

105.00K--How do we evaluate impairments that do not meet one of the 
digestive disorder listings?

    Final 105.00K corresponds to final 5.00I, except that we include 
two additional examples of digestive impairments relevant to children 
that we would evaluate in other body systems. These are the same 
additional examples we included in proposed 105.00E1; however, we made 
minor editorial changes to these examples for clarity.

How are we changing the listings for evaluating digestive disorders in 
children?

105.01 Category of Impairments, Digestive System

Removal of Redundant or Reference Listings
    As in the adult listings, we are removing the following reference 
listings and other listings that are no longer appropriate:
     105.03--Esophageal obstruction, caused by atresia, 
stricture or stenosis, which referred to listing 105.08;
     105.05F--Chronic liver disease with chronic active 
inflammation or necrosis documented by SGOT persistently more than 100 
units or serum total bilirubin of 2.5 mg percent or greater;
     105.07B--Chronic inflammatory bowel disease with 
malnutrition, which referred to listing 105.08; and
     105.07C--Chronic inflammatory bowel disease, with growth 
impairment as described under the criteria in 100.03. However, we are 
adding material to the introductory text in final 105.00G2 to address 
the assessment of growth retardation that is secondary to any digestive 
disorder.
    Prior listing 105.05E, for hepatic encephalopathy, was a reference 
listing, referring to listing 112.02 for organic mental disorders. For 
the reasons we cited in our discussion of prior listing 5.05E (final 
listing 5.05F) above, we are including criteria for evaluating hepatic 
encephalopathy in the digestive listings, final listing 105.05F, 
instead of evaluating this impairment under the criteria for organic 
mental disorders. We will also evaluate the impairment in prior listing 
105.05D, hepatic coma, under final listing 105.05F.
    The following is a detailed explanation of the changed listing 
criteria where they differ from the part A listings.

Listing 105.02--Gastrointestinal Hemorrhaging From Any Cause, Requiring 
Blood Transfusion

    Final listing 105.02, which corresponds to final listing 5.02, was 
not in the NPRM. We are adding it in response to a public comment 
described later in this preamble. The final listing is the same as 
final listing 5.02, except for the amount of blood transfused. In final 
listing 105.02, we provide a ratio of volume of blood to the child's 
weight, which is a more medically appropriate standard for children.

Listing 105.05--Chronic Liver Disease

    Final listing 105.05A replaces prior listing 105.05C, chronic liver 
disease with esophageal varices. The final listing is the same as final 
listing 5.05A, except for the amount of blood transfused. As in final 
listing 105.02, we provide a ratio of volume of blood to the child's 
weight, which is a more medically appropriate standard for children.
    Final listings 105.05C, D, E, F, and G correspond to final listings 
5.05C, D, E, F, and G in part A, with appropriate changes to reflect 
findings and laboratory values for children. Also, final listing 
105.05G includes both an SSA CLD score criterion for children age 12 
and older (final listing 105.05G1) and an SSA CLD-P score criterion for 
children who have not attained age 12 (final listing 105.05G2).
    We provide that an SSA CLD-P score of 11 or greater meets the 
listing. We chose this score based on the clinical severity represented 
by the values contained in the SSA CLD-P score, which we believe 
represents the degree of severity consistent with listing level 
severity.
    For final listing 105.05G2, we require two calculations of SSA CLD-
P scores, at least 60 days apart, and the scores must be calculated 
within a consecutive 6-month period, consistent with other provisions 
in these final rules.
    Final listing 105.05H replaces prior listing 105.05A, inoperable 
biliary atresia. The new listing requires extrahepatic biliary atresia, 
as diagnosed on liver biopsy or intraoperative cholangiogram. We will 
consider children who meet this requirement to be disabled for 1 year 
following the diagnosis, and we will evaluate residual liver function 
after that period.

Listing 105.06--Inflammatory Bowel Disease (IBD)

    We are redesignating prior listing 105.07, chronic inflammatory 
bowel disease, as final listing 105.06 for consistency with the 
corresponding adult listing. Final listing 105.06 is the same as final 
listing 5.06, except that it does not include a criterion for weight 
loss from baseline. This criterion is inappropriate for children 
because they are continually growing, and therefore do not have a 
``baseline weight.'' (We can evaluate weight loss, inadequate growth, 
and malnutrition secondary to IBD under final listing 105.08.)
    Proposed listing 105.06B required IBD with perineal or intra-
abdominal complications, such as abscess, fistulae, or fecal 
incontinence. These complications must have been intractable despite 
medical or surgical treatment, and clinically documented over a 6-month 
period. Final listing 105.06 includes a criterion for perineal disease 
with draining abscess or fistula. However, we did not include fecal 
incontinence because final listing 105.06 includes a much wider array 
of complications resulting from IBD and children with listing-level 
impairments who have fecal incontinence would be evaluated under 
criteria in final listing 105.06.

Listing 105.07--Short Bowel Syndrome (SBS)

    This new listing is the same as final listing 5.07 except that it 
applies to children. It eliminates the need for a finding of functional 
equivalence for children of any age who have a frequent need for a 
central venous alimentation catheter, as we described in the example of 
functional equivalence in prior Sec.  416.926a(m)(3).

Listing 105.08--Malnutrition Due to Any Digestive Disorder

    Final listing 105.08 corresponds to proposed listing 105.08; 
however, as we have already noted, we are including as listing criteria 
three of the examples of laboratory findings that would confirm chronic 
nutritional deficiency we had included in proposed 105.00F1a. We also 
removed the statement from proposed listings 105.08A and B that the 
required findings are ``expected to persist for at least 12 months,'' 
because it is unnecessary. Under our general

[[Page 59407]]

rules for evaluating disability, an impairment must meet the duration 
requirement.
    Final listing 105.08 is consistent with the weight-for-length and 
BMI-for-age charts and data file tables from the CDC. According to the 
CDC, these are the recommended measurements to determine if an 
individual's weight is appropriate for his or her height. On May 30, 
2000, the CDC updated its 1977 weight-for-length growth charts, and 
introduced BMI-for-age charts and tables.\1\ The CDC explained that:

    \1\Centers for Disease Control and Prevention, National Center 
for Health Statistics. CDC growth charts: United States. May 30, 
2000.

    These BMI-for-age charts were created for use in place of the 
1977 weight-for-stature charts. 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.

    As we have already noted, the CDC also defines ``underweight'' in 
children as a BMI-for-age less than the fifth percentile, but neither 
the CDC nor any other recognized expert authority has published 
guidelines for the classification of malnutrition based on BMI. 
Therefore, we will continue to monitor this area, and in the meantime, 
continue to use our criterion of persistence of weight below the third 
percentile to show listing-level severity based on malnutrition for 
children under 2 years of age. The third percentile is generally 
accepted as the lower limit of the normal range for most biologic 
measurements, and persistence below this level would warrant evaluation 
and intervention. Likewise, since the current BMI-for-age charts 
provide percentiles, we will continue to use measurements below the 
third percentile as the listing-level criterion for children age 2 and 
older.
    In response to a comment, we revised proposed listing 105.08B to 
indicate that we use the latest editions of the CDC's charts, which 
will ensure that the listing remains current if the CDC revises its 
charts in the future.

Listing 105.10--Need for Supplemental Daily Enteral Feeding via a 
Gastrostomy

    In response to a public comment, we are adding final listing 105.10 
for the need for a feeding gastrostomy. Because of this new listing, we 
no longer need the functional equivalence example in prior Sec.  
416.926a(m)(10) for a gastrostomy in a child who has not attained age 
3. We are also clarifying that the gastrostomy must be used for 
supplemental enteral feeds on a daily basis.
Conforming Changes

Listing 6.02--Impairment of Renal Function

    For the reasons discussed in the explanation of changes for listing 
5.08, Weight loss due to any digestive disorder, we are also revising 
listing 6.02C4 to use BMI. We are also removing the criterion for 
``recent'' weight loss and replacing it with the same criterion we use 
in the final digestive disorder listings, a requirement for two 
measurements at least 60 days apart within a 6-month period.

Section 416.924b--Age as a Factor of Evaluation in the Sequential 
Evaluation Process for Children

    We are correcting the reference in the last sentence of Sec.  
416.924b(b)(3), which should refer to the functional equivalence 
examples in Sec.  416.926a(m)(7) or (8) but incorrectly designates this 
functional equivalence rule as Sec.  416.924a rather than Sec.  
416.926a. Also, because we are removing two of the examples of 
functional equivalence, Sec. Sec.  416.926a(m)(3) and (10), and 
redesignating the remaining examples as explained below, we are 
revising the reference to refer to final Sec.  416.926a(m)(6) or (7).

Section 416.926a--Functional Equivalence for Children

    We are removing paragraph (m)(3), the example of functional 
equivalence based on a frequent need for a life-sustaining device at 
home or elsewhere, because we are including the need for a central 
venous alimentation catheter as final listing 105.07 and because we now 
no longer need this functional equivalence example.
    We are also removing paragraph (m)(10), the functional equivalence 
example of gastrostomy in a child who has not attained age 3, as it is 
now final listing 105.10.
Other Changes
    We made many editorial changes from the NPRM for clarity in these 
final rules. For example, we:
     Revised many sentences to put them into active voice, to 
simplify them, and to use more consistent style throughout the final 
rules;
     Reorganized some paragraphs into a more logical order;
     Clarified several headings;
     Eliminated some redundancy from the proposed provisions; 
and
     Revised language for greater consistency between part A 
and part B.
    Also, many of the paragraph designations in the NPRM were different 
from the way we designate paragraphs in our other body system listings. 
We changed those designations so they are in the same format as our 
other listings sections. None of these changes are substantive.

Public Comments

    In the NPRM we published in the Federal Register on November 14, 
2001 (66 FR at 57009), we provided the public with a 60-day comment 
period. The comment period ended on January 14, 2002. In response to 
that NPRM, we received letters, telefaxes, and e-mails from 11 
commenters containing comments pertaining to the changes we proposed. 
The commenters included physicians, advocates for individuals who have 
disabilities, individuals who have digestive disorders, and State 
agencies that make disability determinations for us.
    On November 8, 2004, we published a limited reopening of the 
comment period of the NPRM in the Federal Register (69 FR 64702) to 
request additional comments about our proposals to revise and remove 
chronic liver disease listings. We published this limited reopening of 
the comment period because we believed those proposals were 
significant. The comment period also lasted 60 days and ended on 
January 7, 2005. In response to this reopening, we received letters, 
telefaxes, and e-mails from 539 commenters pertaining to the changes we 
proposed regarding chronic liver disease. The commenters included 
physicians, advocates for individuals who have chronic liver disease, 
individuals who have chronic liver disease, and State agencies that 
make disability determinations for us.
    In addition, on November 17, 2004, during the reopened comment 
period, we held an outreach meeting in Cambridge, Massachusetts. At the 
outreach meeting, physicians, advocates for individuals with liver 
disorders, and individuals who have liver disorders provided additional 
comments about chronic liver disease which we included in the 
rulemaking record for these final rules.
    We carefully considered all of the written comments in response to 
the two Federal Register documents and the comments we received at the 
outreach meeting. Because some of them were long and many comments were 
similar, we have condensed, summarized, and paraphrased them below. We 
have tried to present all views adequately and to respond to all of the 
issues raised by the commenters that were within the scope of these 
rules. We provide our reasons for adopting or not adopting the

[[Page 59408]]

recommendations in the summaries of the comments and our responses 
below.

Proposed 5.00A and 105.00A--What kinds of disorders do we consider in 
the digestive system?

    Comment: A commenter who has a colostomy asked us to include 
colostomies in our listings. He described the problems he had been 
having with his colostomy.
    Response: We did not adopt the comment. Although we agree with the 
commenter that some people who have colostomies are unable to work, we 
did not add a listing for this because the vast majority of people who 
have colostomies do not experience long-term complications that would 
meet the 12-month duration requirement and they are able to work. 
However, we did include a statement in final 5.00E4 indicating that if 
an individual is not able to maintain nutrition due to surgical 
diversions of the intestinal tract, including ileostomy and colostomy, 
we will evaluate the impairment under listing 5.08.

Proposed 5.00B and 105.00B--What documentation do we need?

    Comment: Several commenters expressed concerns about our statement 
in the first sentence of proposed 5.00B1 and 105.00B1 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 
decision without it. One commenter was concerned that the proposed 
requirement was overly burdensome, especially for low-income claimants 
and the homeless who are unable to access health care. This commenter 
noted that proposed 5.00B2 (incorrectly designated as 5.00B3 in the 
NPRM) provided guidance for considering medical equivalence when an 
impairment did not meet a listing, but was concerned that adjudicators 
might overlook that guidance because it was in a separate paragraph. 
The commenter was also concerned that administrative law judges would 
need more testimony from medical experts to consider the issue of 
medical equivalence. The commenter asked us to provide more 
alternatives for claimants who, through no fault of their own, are 
unable to access continuous health care treatment.
    Some commenters stated that adjudicators may consider the 6-month 
requirement for observation and treatment absolute and not read the 
introductory text in proposed sections 5.00B3 and 105.00B2. The 
commenters believed that the proposed provision would require our 
adjudicators to defer the adjudication of significant numbers of cases 
with documented impairments of the digestive system until there was 6 
months of evidence, even when it was obvious that those disorders were 
not of listing-level severity. These commenters believed that many 
digestive disorder cases could be fairly evaluated after 3 months of 
treatment and that we could give adjudicators more room for judgment. 
One commenter also suggested that we combine a requirement for 3 months 
of treatment with the establishment of a ``medical improvement 
expected'' diary in appropriate cases, in order to reflect advances in 
medical treatment and the fact that some individuals will respond to 
treatment.
    Many commenters noted that there are some conditions that are 
irreversible or progressive and would not require a 6-month observation 
period since the likelihood of substantial improvement with these 
conditions is negligible.
    Response: In response to these comments, we reorganized proposed 
5.00B1 and 105.00B1 and removed the sentence stating that we usually 
need evidence covering a 6-month period of observations and treatment. 
We did not mean to imply that we would require evidence of 6 months of 
observation and treatment for all cases involving digestive disorders. 
We agree with the commenters that some digestive disorders are 
irreversible and progressive and could be fairly evaluated after 3 
months of treatment, or even less. For example, final listing 5.02 does 
not require 6 months of evidence if the 3 required hemorrhages and 
transfusions occur in less than a 6-month period, as long as the 
transfusions are at least 30 days apart; and listing 5.05A requires 
only one episode of bleeding varices that require blood transfusion. In 
response to comments, we also added three new listings for chronic 
liver disease (final listings 5.05C, D, and E) that can be satisfied 
with documentation of the required findings on only one occasion.
    We recognize that some individuals may not have access to ongoing 
treatment and that, because of this, they may not be able to 
demonstrate that their impairments meet the criteria of listings in 
this body system. As we explain in final 5.00C6 and 105.00C6, it may be 
necessary to determine whether an individual's impairment or 
impairments medically equal a listing or are disabling based on 
consideration of residual functional capacity. We do not believe that 
adjudicators will overlook this guidance in the introductory text 
because it reflects general adjudicative policy that applies to all the 
body system listings. Also, our adjudicators are well aware that they 
are required to consult the information in the introductory text when 
they apply the listings. We will also provide training for our 
adjudicators on these rules.
    It may be possible that administrative law judges (ALJs) will need 
to consult with medical experts somewhat more frequently than they did 
under the prior listings, but we do not believe that there will be a 
large increase in this need. We expect that most cases that would have 
met prior digestive disorder listings and that will not meet any of the 
final listings will require an individualized residual functional 
capacity assessment and will not require such expert medical input to 
determine whether the individual's impairment medically equals a 
listing.
    Comment: Another commenter noted that, while many homeless 
individuals infected with hepatitis C virus (HCV) do not have medical 
records that reflect a complete longitudinal history of medical 
treatment, they may have some medical evidence. The commenter said that 
we should contact the treating physicians instead of purchasing 
consultative examinations. The commenter expressed the view that a 
consultative examiner may not be familiar with treating people with 
HCV, especially those who are homeless. The commenter indicated that 
SSA could save financial resources and secure better evidence for use 
in evaluations if all community medical sources were contacted.
    Response: We make every reasonable effort to secure evidence from 
individuals' treating physicians and other medical sources. Sections 
404.1512 and 416.912 of our regulations require us to make every 
reasonable effort to obtain a complete medical history from an 
individual's medical sources. However, the regulations also explain 
that we will order a consultative examination if the information we 
need is not readily available from the records of the individual's 
medical sources or if we are unable to obtain clarification from the 
medical sources.

Proposed 5.00C and 105.00C--How do we evaluate digestive disorders 
under listings that require persistent or recurrent findings?

    Comment: One commenter stated that our requirement that a 
``recurrent'' or ``persistent'' finding must have lasted or be expected 
to last for 12 months is medically inappropriate for decompensated 
cirrhosis because continued deterioration is expected. The commenter 
also indicated that three events within a 6-month period with 1

[[Page 59409]]

month between events is medically inconsistent with the natural history 
of chronic liver disease because the disease is chronic and, therefore, 
progressive. The commenter acknowledged that some individuals with 
chronic liver disease experience episodes of symptoms and signs, but 
said that we should not have episodic requirements alone for the 
evaluation of the condition.
    Response: We agree with the commenter that we do not need episodic 
requirements or evidence of persistence for all cases involving chronic 
liver disease. Based on this and other comments, we removed proposed 
5.00C and 105.00C and added final listings 5.05C through 5.05G. By 
making these changes, we provide additional criteria that are 
appropriate for evaluating the impairments of individuals who have 
progressive, chronic liver disease. Final listings 5.05A, 5.05C, 5.05D, 
and 5.05E provide for a determination of disability based on findings 
on a single occasion. On the other hand, final listings 5.05B, 5.05F, 
5.05G, and 5.08 include conditions that may be acute or chronic and 
that may respond to treatment. They contain requirements for episodes 
of symptoms and signs.

Proposed 5.00D and 105.00D (final 5.00C and 105.00C)--How do we 
consider the effects of treatment?

    Comment: One commenter suggested that we discuss how the side 
effects of medication can affect a child's growth and social 
development. Another commenter noted that treatment side effects can be 
debilitating and can cause functional limitations that validate 
disability. The commenter recommended that we expand our system of 
disability evaluation to acknowledge and articulate how treatment can 
affect a child's physical, emotional, and social development, including 
specifying how these factors (including school performance) should be 
evaluated. This commenter said that we should integrate all aspects of 
functional development into the evaluation criteria.
    Response: We did not adopt these comments because we believe that 
these final rules and our other rules sufficiently address issues of 
developmental delay and other potentially adverse effects of treatment. 
These final rules include general guidance to our adjudicators in final 
105.00C about assessing any adverse effects of treatment. Final 
105.00D4 includes a detailed discussion of the effects of treatment for 
chronic viral hepatitis infections, including hepatitis B and C virus. 
We explain that treatment for chronic viral hepatitis infections will 
vary considerably due to a child's age, medication tolerance, treatment 
response, and duration of the treatment. While we do not include the 
specific example of effects on ``development'' recommended by the first 
commenter, we do include a number of other examples of more common 
adverse effects of treatment in children.
    In addition, we have other rules for evaluating disability in 
children, and these rules address the kinds of issues raised by both 
commenters. In Sec.  416.924a(b)(9) of our regulations, we include a 
detailed explanation of how we consider the effects of treatment in 
children. This section explains that we consider, among other things, 
any functional limitations that are caused by the side effects of 
treatment and the frequency of the need for treatment; in the latter 
case, we explain that frequent therapy may interfere with a child's 
participation in typical daily activities, which implicitly can also 
affect development. Likewise, in Sec.  416.926a we include additional 
guidance explaining that we consider limitations that result from 
treatment when we make determinations about functional equivalence (see 
Sec.  416.926a(a)). In the sixth domain of functioning, ``health and 
physical well-being,'' we consider the cumulative physical effects of 
physical or mental impairments and their associated treatments or 
therapies on a child's functioning (see Sec.  416.926a(1). We also 
explain that medications and other treatments a child receives may have 
physical effects that also limit his or her performance of activities 
(see Sec.  416.926a(a)(3)).
    Comment: One commenter disagreed with the proposed guidance on 
parenteral and specialized enteral nutrition. The commenter stated that 
individuals who have intravenous or gastrostomy tubes require special 
equipment and frequently require multiple feedings a day that may 
entail a significant amount of time. In the commenter's opinion, this 
is so intrusive that individuals who require parenteral or specialized 
enteral nutrition to avoid debilitating complications of a disease 
should be considered not able to work, and disability should be 
established if the 12-month duration requirement has been, or is 
expected to be, met.
    Response: We partially adopted the comment. There is a wide range 
in the nature and severity of underlying diseases that require 
parenteral or supplemental enteral nutrition, the type of delivery and 
scheduling of administration of such nutrition, and potential related 
complications. Many individuals who receive home parenteral or 
supplemental enteral nutrition have a reasonably normal lifestyle, 
including regular employment. Therefore, we do not think it appropriate 
to presume disability in all individuals who need such treatment; we 
must evaluate most situations on a case-by-case basis. However, we did 
agree that in certain instances the need for parenteral nutrition can 
be disabling. Therefore, we added final listings 5.07 and 105.07 for 
short bowel syndrome when post-operative nutritional needs cannot be 
met orally and an individual requires daily parenteral nutrition via a 
central venous catheter. We also added a criterion based on the need 
for daily enteral nutrition via a gastrostomy or daily parenteral 
nutrition via a central venous catheter in final listings 5.06 and 
105.06 for IBD.
    As a consequence of the changes we made in response to this 
comment, we are also removing two of the examples of functional 
equivalence in Sec.  416.926a(m). Section 416.926a(m)(3) provided for a 
finding of functional equivalence for children of any age who have a 
frequent need for a life-sustaining device, ``e.g., central venous 
alimentation catheter.'' Section 416.926a(m)(10) provided for a finding 
of functional equivalence for children who have not attained age 3 and 
who have a gastrostomy. Therefore, in these final rules, we are 
removing functional equivalence examples (m)(3) and (m)(10) because we 
no longer need them, as we explained earlier in this preamble.
    If we determine that the impairment does not meet or medically 
equal one of these listings, we will consider the need for parenteral 
or supplemental enteral nutrition via a gastrostomy in our residual 
functional capacity assessment or functional equivalence determination, 
especially in the kinds of situations described by the commenter. For 
example, the functional equivalence domain for children called ``health 
and physical well-being'' requires us to consider the cumulative 
physical effects of physical or mental impairments and their associated 
treatments or therapies on the child's functioning (see Sec.  
416.926a(l)).

Proposed 5.00F and 105.00F--What are our guidelines for evaluating 
specific digestive disorders? (Final 5.00D and 105.00D--How do we 
evaluate chronic liver disease?)

    Comment: Several organizations made suggestions for specific 
language changes to the introductory text of the

[[Page 59410]]

listings (proposed 5.00 and 105.00). Many commenters asked us to expand 
our discussion of the signs, symptoms, and complications of chronic 
liver disease. They asked us to list symptoms, such as chronic fatigue, 
chronic indigestion, diarrhea, constipation, and sleep disturbances. 
Commenters also proposed that we add specific laboratory findings to 
the introductory text, such as decreased platelets and acid-base 
imbalances. They suggested that we should take into account the 
frequency of extrahepatic manifestations resulting from chronic liver 
disease and factor them into the medical evaluation.
    Response: We partially adopted these comments by expanding the 
introductory text to provide additional adjudicative guidance on 
symptoms and signs of chronic liver disease. We are providing general 
information on symptoms and signs in final 5.00D3 and 105.00D3, and, 
where appropriate, specific information about symptoms and signs of 
particular chronic liver diseases. For example, in final 5.00D4c(ii) 
and 105.00D4c(ii), we provide examples of symptoms associated with the 
adverse effects of treatment for chronic hepatitis C virus infection, 
and in final 5.00D4d and 105.00D4d, we also provide examples of 
extrahepatic manifestations of chronic viral hepatitis by body system. 
We did not adopt all the specific language commenters requested because 
certain symptoms, such as indigestion, diarrhea, and constipation, are 
generally not features of chronic liver disease. However, we did 
include in final 5.00D3c and 105.00D3c decreased platelet count in the 
list of laboratory findings associated with chronic liver disease, and 
we indirectly referenced acid-base imbalances by adding increased 
ammonia levels as another laboratory finding.
    Comment: One commenter suggested that we add the phrase ``or the 
remainder of an individual's natural life'' to the first sentence of 
proposed 5.00F2 (final 5.00D1). This sentence described chronic liver 
disease and explained that it persists for more than 6 months and is 
expected to continue for at least 12 months.
    Response: We did not adopt the comment. The issue in our initial 
disability determinations and decisions under the listings is whether 
the individual has an impairment that prevents him or her from engaging 
in any gainful activity (or in a child, that causes ``marked and severe 
functional limitations'') and that has lasted or can be expected to 
last for a continuous period of 12 months or that is expected to result 
in death. We are required by law to reevaluate the disability status of 
all individuals who qualify for disability benefits and this applies 
even to people who have permanent impairments. Therefore, there would 
be no practical reason for us to add the phrase requested by the 
commenter.
    Comment: One commenter recommended that we delete the word 
``function'' in proposed 5.00F2d and 105.00F2e when referring to liver 
tests because liver enzymes are not liver function tests.
    Response: We adopted the comment in final 5.00D3c and 105.00D3c.
    Comment: One commenter suggested we delete the word ``minimal'' 
when referring to ascites in proposed 5.00F2(d) and 105.00F2(e) (final 
5.00D6 and 105.00D6) and that we change it to ``small volume.'' The 
commenter also suggested that we delete ``and not on physical 
examination'' in this same section to more clearly indicate that we are 
referring to incidental and clinically insignificant findings of 
ascites found on imaging studies alone.
    Another commenter indicated that ascites should be evident on 
physical examination and not identified solely by an imaging procedure 
that might show clinically insignificant findings of ascites. This 
commenter also suggested listing criteria based on intractable ascites, 
documented on physical examination as moderate to severe, or 
hydrothorax, poorly controlled by or unresponsive to diuretic 
treatment, or requiring paracenteses for control.
    Response: We agree with the commenters that current imaging 
techniques are capable of detecting even minimal amounts of ascites 
before detection may be possible on physical examination. However, the 
criteria of proposed listings 5.05B2 and 105.05B2 did not base severity 
solely on the presence of ascites detected by physical examination or 
by imaging studies; nor do these final listings. To meet the severity 
requirement, the laboratory findings in final 5.05B2 and 105.05B2 must 
also be present. If the laboratory findings are at the level specified 
in the listing, it is not necessary to quantify the ascites because 
there will be sufficient information to show that the individual is 
disabled. Therefore, we did not adopt the comment to change the 
quantifier from ``minimal'' to ``small volume'' ascites; instead, we 
removed it.
    We adopted the second commenter's suggestion to include criteria in 
final listing 5.05B and 105.05B for hydrothorax because ascitic fluid 
can collect in the chest cavity and result in a very serious 
impairment. We did not adopt the other recommendation that we 
characterize listing-level ascites as ``moderate to severe,'' because 
these terms are subject to varying interpretations and their use would 
not promote consistent adjudication.
    Comment: One commenter suggested that we provide detailed 
information about a number of extrahepatic manifestations and 
complications of chronic liver disease and suggested additional 
language for proposed 5.00F (final 5.00D).
    Response: Based on this and other comments, we added language in 
final 5.00D7 through D11 and the corresponding paragraphs in 105.00. 
These sections provide guidance relevant to the application of the new 
listings we are adding for complications of chronic liver disease; that 
is, final listings 5.05C through G and 105.05C through H. We also 
provide information on extrahepatic manifestations of hepatitis B and C 
in final 5.05D4d and 105.05D4d. The additional information we provide 
is relevant only to application of the listings, and therefore, does 
not include the amount of detail this commenter suggested.
    Comment: Several commenters requested that we provide a listing for 
individuals placed on a liver transplant list. They submitted proposals 
for the introductory text to explain this suggested listing.
    Response: We did not adopt the suggestion of placement on a liver 
transplant list alone as a listing because the threshold criteria for 
placement on a transplant list vary widely throughout the country and 
because individuals may be placed on a list well before they have 
listing-level impairments. However, based on this and other comments we 
added final listings 5.05G and 105.05G for end stage liver disease 
documented by particular scores determined using the SSA Chronic Liver 
Disease (SSA CLD) calculation and SSA Chronic Liver Disease-Pediatric 
(SSA CLD-P) calculation. We based these calculations on the Model for 
End Stage Liver Disease and the Pediatric End Stage Liver Disease (MELD 
and PELD) scales that were developed by the United Network of Organ 
Sharing for prioritizing patients waiting for liver transplants based 
on statistical formulas for predicting mortality from liver disease.
    Comment: One commenter noted that liver patients regularly have 
laboratory studies to track their liver function. Any decline in 
function is evident almost immediately and these laboratory studies are 
often done bi-weekly, or weekly in some cases. The commenter said that 
we should be able to use the laboratory findings rather than wait until 
a patient's condition declines to

[[Page 59411]]

the point that he or she needs a liver transplant.
    Response: We partially adopted the comment. Although we have 
indicated that laboratory studies may not be a good indicator of 
disability, since there may be a poor correlation between the studies 
and the severity of liver disease, we believe that some laboratory 
findings can be indicative of listing-level severity for certain 
disorders, such as spontaneous bacterial peritonitis (final listings 
5.05C and 105.05C), hepatorenal syndrome (final listings 5.05D and 
105.05D), hepatopulmonary syndrome (final listings 5.05E and 105.05E), 
and end stage liver disease (final listings 5.05G and 105.05G).

Final Listing 5.02--Gastrointestinal Hemorrhage From Any Cause, 
Requiring Blood Transfusion

    Comment: Proposed listing 5.02 specified that at least 2 units of 
blood must be transfused per episode. One commenter expressed concern 
that different physicians and different religious preferences can 
dictate when and how much blood is transfused. The commenter said that 
it appeared more reasonable to use hematocrit levels, which are 
standardized, instead of a more subjective and less standardized method 
based on the number of units transfused.
    Response: We did not adopt the comment to use a hematocrit level in 
this listing because it takes time for the hematocrit to equilibrate 
following rapid blood loss. We also did not adopt the comment to remove 
the 2-unit requirement for the amount of blood transfused per episode 
in final listing 5.02. As we explained earlier, we chose 2 units of 
blood because this is the minimum amount of blood that is usually 
transfused.
    We recognize that there are individuals who may object to 
transfusions. In such cases, their impairments cannot meet the 
requirements of any listing that includes a criterion for a 
transfusion. However, it is certainly possible for a person who refuses 
transfusions to be found disabled under our other rules for determining 
disability.
    Comment: One commenter noted that in proposed listing 5.02 we 
stated that all incidents within a consecutive 14-day period constitute 
one episode, but in proposed 5.00C2 we also stated that there must be 
at least 1 month between events (incidents). The commenter asked us to 
clarify these requirements because it seemed that all events within a 
30-day period should constitute one episode.
    Response: We clarified the requirements by deleting the sentence in 
proposed listing 5.02 that referred to episodes within a 14-day period 
because it could have been confusing and was not necessary for 
correctly applying the listing. Although our intent was to explain that 
several bleeds may occur during a single episode, listing-level 
severity is based on hemorrhages that require transfusions and not the 
actual number of bleeds per episode. We require 30 days between 
hemorrhages that require transfusion in order to establish that there 
are separate events and that the condition is chronic.

Final Listings 5.05 and 105.05--Chronic Liver Disease

    Comment: One commenter recommended that we place the study 
``endoscopy'' before ``x-ray'' in listing 5.05A because 95 percent of 
diagnoses for varices are made by endoscopy.
    Response: We adopted the comment.
    Comment: We received many comments asking us to change the headings 
of listings 5.05 and 105.05. Commenters suggested eliminating the words 
``and cirrhosis of any kind,'' stating that ``cirrhosis'' is chronic 
liver disease. Commenters also pointed out that individuals may have 
chronic liver disease but not necessarily cirrhosis.
    Response: We adopted the comments and removed the reference to 
``cirrhosis'' from the headings of the two listings.
    Comment: One commenter stated that the definition of cirrhosis can 
be subjective. The commenter said that one doctor who reads a tissue 
sample may diagnose fibrosis and another doctor may diagnosis 
cirrhosis. This commenter stated he had had debilitating symptoms 
before he officially had cirrhosis.
    Response: We do not agree that the definition of cirrhosis is 
subjective. Cirrhosis is a disorder defined by pathology. Fibrosis is 
an early form of scarring. Cirrhosis is late-stage disease and readily 
distinguishable by pathologists from fibrosis. We do agree, however, 
that individuals can have debilitating problems from chronic liver 
disease before they develop cirrhosis. As we have noted in a number of 
places throughout this preamble, we have expanded and clarified the 
final rules to ensure that we identify people without cirrhosis who 
should qualify under these final listings.
    Comment: Many commenters noted that the proposed changes for 
chronic liver disease contained fewer criteria (physical examination, 
laboratory, or imaging tests) to establish disability than did the 
prior listings. They expressed concern about ``compressing'' prior 
listings 5.05 B, C, D, E, and F into proposed listing 5.05B, which 
contained only two sets of severity criteria. Some commenters said that 
the proposed listings were vague and too narrow in scope. Commenters 
believed that this would make our determinations more restrictive and 
perhaps erroneous. They urged us to expand the medical evaluation 
criteria to more accurately reflect the pathophysiology of chronic 
liver disease. The commenters believed that the listings should be more 
specific and inclusive with regard to signs, symptoms, complications, 
treatment, and metabolic and functional factors to make the evaluation 
of chronic liver disease more on par with HIV criteria because 
hepatitis C is a systemic illness that encompasses a broad spectrum of 
diseases similar to HIV infection.
    Response: We adopted many of these comments. We significantly 
expanded the listing criteria for chronic liver disease. For example, 
we expanded proposed listings 5.05A and 105.05A to include hemorrhaging 
from gastric or ectopic varices and portal hypertensive gastropathy. We 
also expanded proposed listings 5.05B and 105.05B to include 
hydrothorax as well as ascites. We added four listings in parts A and B 
based on suggestions from commenters: Final listings 5.05C, D, E, and 
G, and 105.05C, D, E, and G. We also replaced the prior reference 
listing for hepatic encephalopathy with a stand-alone listing for this 
complication of chronic liver disease (final listings 5.05F and 
105.05F).
    Analogous to the detailed guidance we provide about HIV infection 
in 14.00D and 114.00D of our listings, we have greatly expanded the 
introductory text to include detailed information on chronic viral 
hepatitis infections in final 5.00D4 and 105.00D4. We provide 
information about the symptoms, signs, and complications of chronic 
hepatitis B and C virus, and include information about the types of 
treatment for these infections and the common adverse effects of this 
treatment. We have also added information on extrahepatic 
manifestations of hepatitis B and C virus by body systems.
    We did not add all of the suggested complications or extrahepatic 
manifestations of chronic liver disease because most respond to 
prescribed treatment and they are generally very rare. Also, some of 
the suggested extrahepatic syndromes are multi-causal, may be unrelated 
to the liver disease, and poorly correlate with the degree of liver 
destruction. Very serious extrahepatic manifestations that we did not 
list in these final rules can be

[[Page 59412]]

evaluated under the affected body system. Lesser manifestations are 
evaluated in the residual functional capacity assessments or functional 
equivalence evaluations later in the appropriate sequential evaluation 
process for adults or children. (We describe the sequential evaluation 
process later in this preamble.)
    Comment: Several commenters suggested we include a classification 
system, such as the Child-Turcotte-Pugh score, which has a refined 
scoring system and has been validated for years as predictive of 
mortality. This score indicates cirrhosis as ``compensated'' and 
``decompensated.''
    Another commenter suggested that we should not use the Child-
Turcotte-Pugh score because it does not pick up some disabilities, but 
we should use the MELD and PELD scoring systems which have replaced it.
    Response: We partially adopted the suggestion to use a 
classification system by including an SSA CLD score criterion in final 
listing 5.05G, and SSA CLD and SSCLD-P score criteria in final listings 
105.05G1 and G2. The SSA CLD and SSA CLD-P calculations are based on 
the calculations for the MELD and PELD scores, but we made minor 
changes to these calculations to make them more appropriate for 
determining disability. We did not base the SSA CLD-P calculation on 
the Child-Turcotte-Pugh score because it has been superseded by the 
PELD in clinical practice.
    Comment: Several commenters were concerned about our proposal to 
remove prior listing 5.05B, for performance of a shunt operation for 
esophageal varices.
    One commenter noted there are still problems that can occur with 
the TIPS shunting procedure, such as occlusion, infection, or failure. 
The commenter noted that TIPS shunting does not have any bearing on the 
severity of the condition that required the shunt. The commenter also 
indicated that, although the shunt will help relieve the pressure 
causing the hemorrhage, it does not bring about a recovery or 
improvement of the liver disease itself.
    The same commenter stated that, after a TIPS procedure, the blood 
is not being filtered by the liver, but is bypassing liver function, 
and that blood toxicity is an issue. The commenter noted that TIPS 
prevents or postpones the next big bleed, but does not cure the 
underlying disease, usually cirrhosis. The debilitating symptoms are 
not eliminated and the patient is unable to perform work or normal 
lifestyle functions.
    Response: We did not adopt the comments asking us to keep prior 
listing 5.05B. As we indicated in the preamble to the NPRM, more modern 
types of procedures, such as TIPS, are less risky and can be performed 
before the condition becomes serious enough to meet the level of 
severity required by our listings. Therefore, we cannot presume that 
everyone who has had a TIPS procedure is disabled. However, we will 
evaluate the severity of the underlying chronic liver disease under 
final listing 5.05, and if it does not satisfy the requirements of the 
listing, we will evaluate the effects of any debilitating symptoms when 
we assess residual functional capacity at later steps in the sequential 
evaluation process.
    We do agree that complications of TIPS may occur. However, if there 
are complications, immediate medical attention would be required, and 
the complications would not last or be expected to last for 12 months.
    We do not agree with the comment that blood is not being filtered 
by the liver after a TIPS procedure. Portal pressure is reduced by the 
TIPS procedure, which connects the portal vein to the hepatic vein 
using a stent (shunt); however, there is still some blood that filters 
through the liver.
    Comment: Many commenters disagreed with our proposal to remove 
prior listings 5.05E and 105.05E for hepatic encephalopathy. They noted 
that this condition is directly related to end stage liver disease and 
affects an individual's ability to work due to manifestations such as 
confusion, poor memory, and lack of concentration. Many commenters also 
recommended that we include criteria for evaluating hepatic 
encephalopathy in the digestive disorders listings rather than 
evaluating the condition in the mental or neurological body systems. 
Another commenter noted that TIPS can cause encephalopathy, and said 
that doing away with listings for shunts and hepatic encephalopathy was 
not a good idea.
    Response: We adopted the comments. Although we are still removing 
prior listings 5.05E and 105.05E because they were reference listings 
that only referred to the mental disorders listings, we are adding new 
listings for hepatic encephalopathy that contain specific evaluation 
criteria, final listings 5.05F and 105.05F. These final listings 
include criteria for the behavioral or cognitive manifestations of 
hepatic encephalopathy in combination with TIPS or any surgical 
portosystemic shunt or in combination with a specific clinical or 
laboratory finding. We are also providing guidance in final 5.00D10 and 
105.00D10 of the introductory text for using the new listings.
    Comment: We received many comments regarding the use of liver 
biopsies in the evaluation of chronic liver disease. Commenters stated 
that individuals with chronic liver disease may suffer from a multitude 
of symptoms and have little evidence of injury to their liver, while 
others may have few symptoms, even with extensive cell damage on liver 
biopsy. Therefore, histological findings may not correlate with 
functional capacity. Others noted that extrahepatic manifestations of 
chronic liver disease cannot be found on liver biopsy, yet these 
manifestations are symptomatic and limiting.
    Also, in an apparent reference to our proposal to remove the 
requirement for confirmation of chronic liver disease by liver biopsy 
in prior listing 5.05F, commenters agreed that a biopsy should not be 
mandatory. However, they indicated that the results of a biopsy could 
help to assess whether an individual has cirrhosis, particularly early 
cirrhosis, since symptoms may not be substantiated by blood tests or 
physical examination.
    Response: We agree with the commenters that a liver biopsy is 
useful in diagnosing cirrhosis, and in final 5.00D3c and 105.00D3c, we 
explain that biopsy may demonstrate the degree of liver cell necrosis, 
inflammation, fibrosis, and cirrhosis. We also agree with the 
commenters that a liver biopsy is not a good predictor of the severity 
of symptoms of chronic liver disease or their effect on functioning. 
Therefore, as we explained earlier, we have removed prior listing 
5.05F, which was based in part on confirmation of chronic liver disease 
by liver biopsy. We will continue to consider liver biopsy reports when 
they are part of the existing medical records in combination with all 
the other evidence in the case record.
    Comment: Several commenters stated that many of the medications and 
procedures used to treat the symptoms of liver disease, such as higher 
dose diuretics, repeated large-volume paracenteses, and placement of 
TIPS for bleeding esophageal varices, have side effects that we should 
consider. The commenters noted that treatment can lead to major 
electrolyte or renal problems.
    Response: We agree that the effects of treatment must be considered 
in assessing digestive impairments. In final 5.00C and 105.00C, we 
provide general guidance for how we consider the effects of treatment 
for all impairments in this body system. In final 5.00D4 and 105.00D4, 
we provide specific guidance

[[Page 59413]]

about how we consider the effects of treatment for chronic viral 
hepatitis infections.
    Also, if an impairment does not meet or medically equal a listing, 
we continue to consider the effects of treatment on the individual's 
ability to function when we assess residual functional capacity, or for 
children, when we assess functional equivalence.
    Comment: Several commenters suggested that we add documented portal 
hypertension to listing 5.05A and 105.05A.
    Response: We adopted the comment.
    Comment: One commenter suggested that proposed listing 105.05A was 
more restrictive than proposed listing 5.02 for adults, with no 
corresponding childhood listing 105.02 for children. The commenter 
suggested that we include a comparable listing for children based on 
three gastrointestinal bleeds requiring transfusion in a 6-month period 
due to any disease process, not just esophageal varices.
    Response: We adopted the comment and added a corresponding 
childhood listing 105.02 with essentially the same provisions as in 
final listing 5.02.
    Comment: Many commenters recommended that we delete the word 
``massive'' from proposed listings 5.05A and 105.05A. They also 
suggested including other sites of bleeding besides the esophagus under 
listing 5.05A, specifically bleeding from gastric and ectopic varices, 
and portal hypertensive gastropathy.
    Response: We adopted the comments and made corresponding changes to 
final 5.00D5 and 105.00D5 of the introductory text which provide 
guidance for applying listings 5.05A and 105.05A. We also changed the 
proposed criteria of these listings, as we explain in our response to 
the next comment.
    Comment: Many commenters opposed the requirement in proposed 
listing 5.05A that an individual receive 5 units of blood in order for 
his or her impairment to meet the requirement for a massive hemorrhage.
    One commenter stated that it would be more reasonable to simply 
require a ``significant hemorrhage.'' This commenter noted that any 
transfusion is significant.
    Another commenter said that specifying the number of units 
transfused could not be supported because the size of the individual, 
the protocol of the hospital, the timeliness of the intervention, and 
other factors could influence the amount of blood transfused. This 
commenter doubted that the prognosis for an individual with bleeding 
varices who receives 4 units is significantly better than for an 
individual who receives 5 units. The commenter thought that, since 
physicians and hospitals are reluctant to transfuse blood, any blood 
transfusion should suffice or the matter should at least be left to 
medical judgment.
    Another commenter said that a transfusion of ``multiple'' units of 
blood in conjunction with other interventions in an attempt to restore 
hemodynamic stability should suffice and that there should be some 
latitude for medical judgment in this listing.
    Another commenter stated that we should include other criteria to 
define a hemodynamically significant bleed, such as at least a 2-unit 
bleed, or a drop in blood pressure and increase in pulse rate. This 
commenter also suggested changing the wording from ``hemodynamic 
instability'' to ``hemodynamically significant bleed'' in the listing 
and the introductory text.
    Response: We partially adopted the comments. We agree that the 
proposed rule was too severe. Therefore, we revised the listing so that 
the primary criterion for listing-level severity is hemorrhaging that 
results in hemodynamic instability and requires hospitalization for 
transfusion. Since the minimum amount of blood a physician will usually 
transfuse in adults is 2 units, we used this amount in the listing.
    In final 5.00D5, we also adopted some of the language suggested by 
commenters to describe hemodynamic instability, including pallor, 
diaphoresis, rapid pulse, low blood pressure, postural hypotension, and 
syncope. (We also provide brief definitions of the more technical 
medical terms on this list.) We do not indicate, as we did in the NPRM, 
that hemodynamic instability may require multiple transfusions because 
final listing 5.05A requires only one transfusion.
    We made similar changes in the part B section for children, but 
provided a rule for documenting appropriate transfusion volumes based 
on body weight.
    Comment: One commenter noted that some people could not meet 
listing 5.05A because they may have many large varices clipped. These 
individuals would be in serious danger and disabled without ever 
bleeding.
    Response: We agree that an individual who has had prophylactic 
banding of varices without a bleed would not meet the requirements of 
final listing 5.05A. However, one of the major complications of 
cirrhosis with portal hypertension is bleeding varices; therefore, a 
criterion for hemorrhaging is appropriate in these listings. An 
impairment that does not meet the requirements of 5.05A because varices 
have been clipped may still meet the requirements of final listing 
5.05B through 5.05G or be disabling on another basis.
    Comment: One commenter stated that the mortality rate associated 
with variceal bleeding has decreased over the last several years with 
advances in therapy. If an individual goes more than a year without 
recurrent bleeding, he or she is back at baseline and has only a 25 
percent risk for bleeding. The commenter recommended that we determine 
disability at that point by the state of decompensation of the liver 
rather than the risk of bleeding.
    Response: All of the criteria in final listings 5.05 and 105.05 are 
based on the state of decompensation of the liver rather than the risk 
of bleeding. The requirement under 5.05A for hemorrhaging that results 
in hospitalization and transfusion reflects one of the major 
complications of chronic liver disease. When we determine whether an 
impairment that met 5.05A continues to be disabling following the 1-
year period of disability, we evaluate any residual impairment(s), 
including bleeding and other complications of chronic liver disease.
    Comment: One commenter stated that the proposed language for the 
length of disability under listings 5.05A and 105.05A (that is, ``for 1 
year following the last documented massive hemorrhage'') did not work. 
The commenter suggested that the correct standard has to be the state 
of decompensation of the liver, not a fixed period of time.
    Response: We did not adopt the comment. As we explained in the 
NPRM, we changed the period for which we would presume the impairment 
is disabling from 3 years to 1 year because of newer techniques in the 
treatment of esophageal varices. (See 66 FR at 57013.) The same logic 
would hold for other bleeds as well.
    Also, it is important to remember that the 1-year rule does not 
mean that disability automatically ends 1 year following the last 
documented transfusion (we removed the description ``massive 
hemorrhage'' as we explained earlier). Our rule is only that after 1 
year we must consider whether the impairment is still disabling. Also, 
our existing rules allow our adjudicators to decide that we will not 
review a case until a date later than 1 year after the qualifying event 
(in this case, the last documented transfusion), if the medical 
evidence supports a conclusion that the disability will continue for 
longer than 1 year.

[[Page 59414]]

    Comment: One commenter objected to the criterion in proposed 
listing 5.05B2a for a cutoff level for serum albumin depletion, stating 
that the actual serum albumin level is dependent upon many factors, 
such as hydration and the degree of portal hypertension. The commenter 
suggested that we change the listing criterion to ``an associated 
decrease in serum albumin.''
    Response: We did not adopt the comment. A serum albumin level of 
3.5 g/dL is normal. Even though a level between 3.0 g/dL and 3.5 g/dL 
may indicate an abnormality, it is does not reflect listing-level 
severity. A level of 3.0 g/dL or less is recognized by hepatologists as 
indicative of loss of liver biosynthesis.
    We set the laboratory values in these listings, such as the serum 
albumin level in 5.05B2a, at a level that reflects very serious 
impairment because we use the listings only to deem individuals 
disabled without considering any other factors that may contribute to 
their inability to work; that is, their residual functional capacity, 
age, education, and work experience. However, the establishment of 
these levels does not mean that individuals whose impairments do not 
satisfy the criteria of the listing are not disabled; it only means 
that we do not presume that they are disabled under the listing. We may 
still find that the impairment is disabling based on an individualized 
assessment of its effects on the individual's functioning.
    Comment: One commenter suggested that we include a criterion for 
malabsorption with involuntary weight loss of 10 percent or more from 
baseline in the absence of a comorbid condition that could explain the 
findings.
    Response: We did not adopt the comment because malabsorption is not 
a common feature of chronic liver disease. However, individuals with 
chronic liver disease and the appropriate degree of weight loss can 
meet the requirements of final listings 5.08 or 105.08.
    Comment: Several commenters suggested that we change the measure of 
coagulation studies from prothrombin time to International Normalized 
Ratio (INR) as many laboratories do not report the prothrombin time in 
terms of seconds, but do report the INR.
    Response: We adopted the comment.
    Comment: Several commenters suggested that we include hepatic 
malignancy as a criterion in listings 5.05 and 105.05, noting that many 
liver diseases result in hepatocellular carcinoma.
    Response: We did not adopt the comment because we already have 
listings for malignant tumors of the liver, listing 13.19 for adults 
and listing 113.03 for children. However, in response to this comment, 
we added a cross-reference to listing 13.19 in final section 5.00D1 and 
to listing 113.03 in final section 105.00D1.
    Comment: Several commenters stated that some hepatic conditions, 
such as Budd-Chiari syndrome, may not include cirrhosis or ascites, but 
are disabling and should be included as conditions for determining 
eligibility for disability benefits.
    Response: We did not add all the specific conditions mentioned by 
the commenters to the listings. However, as already explained, we did 
add several criteria to final listing 5.05 and 105.05 to expand the 
scope of those listings and to address additional manifestations of 
chronic liver disease. We also expanded the introductory text in 5.00D2 
and 105.00D2 to provide examples of chronic liver disease that should 
be considered under the listings when they result in the complications 
specified in the listings. We added guidance regarding the effects of 
the extrahepatic manifestations of chronic liver disease that should be 
considered under the requirements of other body systems or at later 
steps in the sequential evaluation process when the impairment does not 
meet or medically equal a listing in the digestive disorders body 
system.
    Comment: One commenter noted that we proposed to remove the 
laboratory values from prior listings 5.05C and 5.05F and asked why we 
did not propose to delete the laboratory values in proposed listing 
5.05B. The commenter recommended that we delete the values from listing 
5.05B as well.
    Response: We did not adopt the comment. As we explained in the NPRM 
(66 FR at 57013) and have explained earlier in this preamble, we did 
not propose to delete the laboratory values in proposed listing 5.05B 
because they are specific indicators of the severity of the 
deterioration of liver function in that listing. Serum albumin level is 
a good indicator of liver biosynthesis and it correlates with the 
severity of ascites. In addition, blood coagulation disorders resulting 
from chronic liver disease are indicative of the severity of the liver 
dysfunction. However, as we explained earlier in this preamble, we are 
providing a criterion for an elevated INR as a measure of the body's 
ability to regulate coagulation, rather than a prolongation of 
prothrombin time as in the prior and proposed listing, because INR is a 
more widely used study than prothrombin time.
    Comment: Another commenter believed that our proposal to eliminate 
prior listing 5.05C, which required chronic liver disease with elevated 
serum total bilirubin, would be a ``great disservice'' to individuals 
with primary biliary cirrhosis (PBC), primary sclerosing cholangitis 
(PSC), and autoimmune hepatitis (AIH). The commenter noted that 
elevated serum total bilirubin levels and pruritis associated with 
these conditions are very real problems. Also, a commenter noted that 
most primary care doctors are not going to run studies other than the 
serum total bilirubin.
    Response: Even though serum total bilirubin studies may be readily 
available in the medical records from primary care physicians, we are 
removing prior listing 5.05C because, as we explained earlier, this 
laboratory finding alone is not a good indicator of impairment severity 
or an individual's ability to function. However, serum total bilirubin 
is one of the three laboratory values we use to calculate the SSA CLD 
score for final listing 5.05G.
    In response to this comment, we are providing a list of examples of 
chronic liver disease in final 5.00D2. The list includes PBC, PSC, and 
AIH, and will remind adjudicators that these conditions can be 
evaluated under final listing 5.05.
    Comment: One commenter stated that doctors are finding that low 
platelet counts are an indicator of portal hypertension and that they 
should be added to the criteria for listings 5.05 and 105.05. The 
commenter noted that patients are concerned about the amount of 
physical activities they can perform with low platelet counts and 
abnormal coagulation.
    Response: We do not include low platelet counts as stand-alone 
criteria for listing-level severity because there is a wide statistical 
variation in platelet counts, and there is no specific level at which 
individuals will subsequently bleed. We consider any functional 
consequences, such as limitations in an individual's ability to perform 
physical activity, when we assess residual functional capacity in 
adults and functional equivalence in children.
    However, in response to this comment, we added a reference to 
abnormal coagulation studies, including an increased INR level and 
decreased platelet counts, in our list of laboratory studies associated 
with chronic liver disease in final 5.00D3c and 105.00D3c. We explain 
that elevated INR level does indicate loss of synthetic liver function, 
as well as increased likelihood of cirrhosis and associated 
complications. We also include an elevated INR level

[[Page 59415]]

in the criteria of listings 5.05B and 105.05B.
    Comment: Proposed listings 5.05B and 5.06 contained criteria that 
required specific findings to occur during a consecutive 6-month 
period. Commenters believed that our proposal to change the requirement 
that ascites persist for 5 months in prior listing 5.05D to a 
requirement for 6 months in proposed listing 5.05B seemed arbitrary and 
unfair because not all impairments fit neatly into 6-month blocks. 
(There was no 6-month requirement in prior listing 5.06.) The 
commenters believed that we changed the listing simply to coincide with 
an arbitrary timeframe without regard for long-held understanding of 
medical severity. One commenter believed that the period was excessive 
because clinically significant ascites for 3 months despite treatment 
represents serious liver disease.
    Another commenter questioned how we would handle cases in which the 
appropriate findings persist consecutively over a 2- to 5-month period, 
improve for a few months, and then recur for a few months. The 
commenter asked if a case involving multiple recurring periods, none of 
which individually lasts up to 6 consecutive months, could equal either 
of these listings.
    Response: As we explained in the NPRM, ``[i]n our experience, 
requiring 6 months of persistent findings enables us to make a more 
reliable prediction of listing-level severity.'' (See 66 FR at 57013.) 
Requiring findings from at least two evaluations, at least 60 days 
apart, within a consecutive 6-month period allows us to document the 
recurrent or persistent nature of many of these impairments and is a 
more reliable indicator that the impairment will be disabling for 12 
consecutive months. When these listing requirements are satisfied, we 
can generally conclude that the impairment will be disabling for 12 
consecutive months.
    In the two examples provided by the commenters (that is, clinically 
significant ascites for 3 months despite treatment, or findings 
persisting for 2 to 5 months that improved for a few months and then 
recurred), the impairments would meet the listing if there was evidence 
showing the required findings on two evaluations spaced at least 60 
days apart. These examples show that we do not necessarily need 6 
months of evidence to find that an impairment meets the listing. Also, 
as we have already noted, if the impairment does not meet the criteria 
of any of these final listings, it may meet the criteria of a listing 
in another body system, medically equal a listing, or meet the 
definition of disability later in the sequential evaluation process.
    Comment: One commenter believed that we should not require 
documentation of ascites by both physical examination and appropriate 
medically acceptable imaging under proposed listings 5.05B2 and 
105.05B2. The commenter stated that imaging studies are not always 
available and that, if ascites is observable on examination and the 
serum albumin or coagulation studies criterion in the listing is 
fulfilled, it seems unnecessary to also require documentation by 
imaging. Another commenter noted that it is difficult to demonstrate 
ascites in obese people by physical examination, and requiring both 
types of documentation could reduce the chance that an individual who 
is obese would benefit from this listing.
    Another commenter stated that our proposed listing 5.05B criteria 
did not quantify the amount of ascites and that we should be evaluating 
significant ascites.
    Response: We adopted the first two comments by providing in final 
listing 5.05B2 that ascites or hydrothorax can be demonstrated by 
appropriate medically acceptable imaging ``or'' by physical 
examination. Since the required laboratory findings in final listings 
5.05B2 establish the severity of the impairment under the listings, we 
agree that there is no need to require documentation of ascites both on 
physical examination and on imaging. Because of this change in the 
final rules, individuals with obesity will be able to meet this listing 
with ascites demonstrated on imaging techniques alone, provided they 
meet the other criteria of the listing.
    Because of this comment, we also reviewed the same criterion in 
proposed listing 105.05. For consistency, and because it is medically 
appropriate, we included the same requirements for children in final 
listing 105.05B as we do for adults in final listing 5.05B. We also 
restored the criterion from prior listing 105.05B for an associated 
serum albumin of 3.0 g/dL or less and added a criterion for an INR of 
1.5 consistent with final listing 5.05B. This will ensure that the 
ascites is a sign of chronic liver disease.
    Because we are requiring the associated laboratory studies with the 
ascites to demonstrate listing-level severity, we will not need to 
quantify the amount of ascites.
    Comment: One commenter recommended that we not delete listing 
105.05A, inoperable biliary atresia, and require children to prove 
disability in other ways.
    Response: We adopted the comment. In final listing 105.05H, we have 
clarified that the listing applies only to extrahepatic biliary 
atresia, thus excluding other types, such as intrahepatic biliary 
atresia. We are no longer using ``inoperable'' to describe the 
condition, because by definition, extrahepatic biliary atresia cannot 
be remedied with surgery except by liver transplantation; the 
portoenterostomy procedure usually performed in the first 3 months of 
life is only palliative.
    Comment: One commenter believed that our requirement for 
prolongation of the prothrombin time of at least 2 seconds in proposed 
listing 5.05B2(b) was medically unreasonable and might be excessive. 
The commenter suggested that any reading above the normal value for the 
reporting laboratory should qualify.
    Response: We disagree with the comment; however, we have removed 
the proposed criterion for measurement of prothrombin time and instead 
provided a criterion for INR in final listing 5.05B2 because INR is a 
more widely used study than prothrombin time. As we explained earlier, 
because we use the listings to deem individuals disabled, we must set 
laboratory values in the listings at levels that reflect very serious 
impairment.
    Comment: One commenter suggested that we include in listing 105.05 
consideration of poor school performance, difficulties in play, and 
growth and developmental delays. The commenter gave examples of 
developmental delays due to ascites, such as inability to roll over.
    Response: We did not include this information in the listing, but 
in response to this comment we did note in final 105.00D3 in the 
introductory text that the manifestations of chronic liver disease may 
include developmental delays or poor school performance. The issues 
raised by this comment are more appropriately addressed when we make 
functional equivalence determinations under Sec.  416.926a, where we 
provide detailed, age-specific guidelines for evaluating limitations in 
school, play, and various other developmental issues.
    Comment: Many commenters stated that we should include a separate 
listing for chronic hepatitis B and C. Some suggested that we do not 
recognize the hepatitis C virus as a disability and they believed that 
it is ``unacceptable'' to evaluate individuals with chronic hepatitis C 
virus under the chronic liver disease listings. Some commenters thought 
that our proposals would

[[Page 59416]]

restrict individuals with hepatitis C from receiving benefits. One 
commenter said that our proposed changes did not take into account 
knowledge gained in the last 20 years regarding the hepatitis C virus. 
Some commenters thought we were removing hepatitis C and all liver 
diseases from the listings, while others suggested that we wrote the 
chronic liver disease listings only for alcoholic and drug-induced 
liver failure.
    Response: We are not removing chronic liver disease from the 
listings, and we do recognize and include hepatitis C, which is a 
chronic liver disease, under final listings 5.05 and 105.05.
    We believe that the many changes and improvements we are making in 
the final listings and the introductory text in response to these and 
other comments will make clear that final listings 5.05 and 105.05 
apply to all forms of chronic liver disease, including disease caused 
by the hepatitis B and C viruses. As we have already explained, final 
listings 5.05 and 105.05 are now broader in scope and more inclusive 
than the proposed listings were. We did not add a separate listing for 
chronic hepatitis B or C because individuals with listing-level effects 
of hepatitis will have the same kinds of findings as those associated 
with other chronic liver diseases.
    In response to these and other comments about chronic viral 
hepatitis, we are also adding extensive sections to the introductory 
text to address many of the concerns expressed in the comment letters 
and at the outreach conference. Final 5.00D4 and 105.00D4, which 
explain how we evaluate chronic viral hepatitis, are the longest 
sections in the introductory text. We have provided subsections 
explaining:
     The nature and course of hepatitis B and C infections;
     Treatment, including the adverse effects of treatment; and
     Extrahepatic manifestations of hepatitis B and C.
    With these changes, we believe it will now be very clear that we do 
consider hepatitis B and C to be medically determinable impairments 
that could be the basis for a finding of disability. We explain how 
these impairments can meet the requirements of final listings 5.05 and 
105.05, and how they can be disabling in other ways, either by meeting 
other listings, medically equaling listings, or based on the functional 
consequences of the impairments as a result of symptoms and the effects 
of treatment. It should also be clear that we do not intend to restrict 
the entitlement to disability benefits of individuals who have 
hepatitis B or C; rather, we intend to include everyone who should 
qualify under our rules. The new information in final 5.00D4 and 
105.00D4 will also ensure that our adjudicators have up-to-date 
information about hepatitis B and C.
    Comment: Some commenters indicated that the debilitating symptoms 
of hepatitis C virus often begin decades before end-stage liver failure 
occurs. Some commenters recommended that we include criteria for 
hepatitis like the criteria in listings 14.08N and 114.08O, for human 
immunodeficiency virus (HIV). Those listings provide for a finding of 
disability based on significant documented symptoms or signs with 
specified functional limitations. The commenters indicated that the 
symptoms and signs of hepatitis, such as decreased cognitive function, 
decreased memory acuity, fatigue, weakness, fever, malaise, lethargy, 
weight loss, abdominal pain, appetite disturbance, mood disturbance, 
and insomnia, are in many respects the same as the symptoms and signs 
we include in listings 14.08N and 114.08O. The commenters noted that 
both HIV and chronic hepatitis B and C are systemic illnesses that 
encompass a broad spectrum of diseases and potential impairments with 
many constitutional and systemic signs and symptoms.
    One commenter stated that including a listing based on functional 
limitations would be important for individuals who are homeless and 
whose functional disabilities may be very profound. The commenter noted 
that it would be easier to document the functional limitations than the 
medical conditions because expert medical care may not be available to 
this group.
    A group of physicians who spoke at the outreach meeting commented 
that they ``struggled with the dilemma of'' how we should evaluate 
fatigue because they believe it is subjective and difficult to assess 
and validate. They recommended that the assessment of the validity and 
impact of fatigue should rest on the judgment of the treating source.
    Response: We did not adopt the comments. While we agree that some 
individuals with hepatitis B and C may be debilitated by symptoms of 
fatigue and the other symptoms mentioned by the commenters, we believe 
it would be more appropriate to consider these symptoms on a case-by-
case basis at later steps of the sequential evaluation process, based 
on information obtained from the treating source(s) as well as other 
medical and non-medical sources concerning the particular effects of 
the impairments on residual functional capacity or, for children, age-
appropriate functioning.
    Also, we do not believe we should add a functional listing to the 
final rules without first proposing it and asking for public comment on 
the criteria it might contain. Therefore, even though we are not adding 
such a listing now, we plan to issue an Advance Notice of Proposed 
Rulemaking inviting public comments on whether we should add a 
functional listing to the digestive disorders body system and, if so, 
what functional criteria would be appropriate.
    With regard to the comment that we should add a listing based on 
functional limitations for individuals who are homeless, we do not 
believe we should add a listing at this time for the reasons stated 
above; however, we do evaluate functional limitations that result from 
the symptoms and signs of an impairment when we assess residual 
functional capacity.
    We agree with the physicians who spoke at the outreach meeting that 
the fatigue associated with hepatitis B and C is often substantial but 
also difficult to assess and validate. We also agree that treating 
physicians can provide important information about the validity and 
impact of fatigue on functioning. In fact, our regulations at 
Sec. Sec.  404.1527 and 416.927 require us to consider medical source 
opinions about the nature and severity of impairments, including 
opinions about symptoms and their effects on functioning. However, 
these same rules do not allow us to rely solely on the judgment of the 
treating physician, as the commenters may have been suggesting. The 
rules identify factors we must consider in determining whether to 
accept a treating source's medical opinion, including an opinion about 
an individual's symptoms. We must also evaluate the symptom of fatigue 
under Sec. Sec.  404.1529 and 416.929 of our regulations, which provide 
a variety of factors that we must consider.
    Comment: One commenter suggested that hepatitis C should be 
included in the hematological body system (7.00 and 107.00) since it is 
a blood-borne virus.
    Response: We did not adopt the comment because hepatitis is 
primarily a liver disorder and should be evaluated in the digestive 
disorders body system.
    Comment: One commenter stated that only those individuals who 
suffer from hepatitis C know the extent of their symptoms and only they 
should make judgments about the appropriate disability criteria for 
this disease.
    Another commenter recommended that we employ doctors who deal with 
a large number of patients with hepatitis. The commenter further

[[Page 59417]]

recommended that we consult with the American Association for the Study 
of Liver Disease (AASLD) for a list of experts in the field. Another 
commenter indicated that some doctors who do not deal regularly with an 
indigent population or those that have retired from active practice may 
not have expertise in assessing hepatitis B and C. The commenter 
recommended that community health centers or other public entities 
should be used as a source of medical expertise.
    Response: As we note at the beginning of the comment and response 
section of this preamble, we reopened the comment period on the NPRM so 
that we could receive additional input on our rules for evaluating 
chronic liver disease. In addition to the outreach meeting we conducted 
in Cambridge, Massachusetts in November of 2004, at which a number of 
experts presented, we also asked other people with expertise to send us 
written comments. As a result of these efforts, we received many 
comments from medical specialists, advocates who specialize in chronic 
liver disease (including hepatitis B and C), and patients. We adopted 
many of the comments from these individuals.
    We generally agree with the commenters who indicated that it would 
be better if we used doctors in our program who have expertise in 
evaluating and treating individuals with hepatitis, or any chronic 
liver diseases, and we do use such experts whenever possible. We also 
asked the Institute of Medicine of the National Academies to study the 
issue of medical expertise in our disability evaluations and to 
recommend ways in which we can make better use of medical expertise in 
our case adjudications. They issued their report, Improving the Social 
Security Disability Decision Process, on February 13, 2007.\2\ We are 
now considering their findings and recommendations for future 
improvements.
---------------------------------------------------------------------------

    \2\ Institute of Medicine of the National Academies, Committee 
on Improving the Disability Decision Process. Improving the Social 
Security Disability Decision Process. Washington, DC: The National 
Academies Press, 2007. The report is available at http://www.nap.edu/catalog.php?record_id=11859.
---------------------------------------------------------------------------

    Comment: One commenter said that a Veterans Administration (VA) 
disability rating of 100 percent due to hepatitis C should trigger 
automatic payment of Social Security disability benefits, as it does 
for disabled railroad employees. The commenter stated that this would 
save tax dollars and eliminate inequity between the two Federal 
programs.
    Response: We did not adopt the comment. Under sections 205(b)(1) 
and 1631(c)(1)(A) of the Act and Sec. Sec.  404.1504 and 416.904 of our 
regulations, we are required to make a determination of disability 
independent of other agencies, such as the VA. Also, the disability 
standard the VA uses is not the same as our disability standard. 
However, our regulations do provide that we must consider 
determinations made by other agencies, including the VA, when we make 
our determinations and decisions (see Sec. Sec.  404.1504, 
404.1512(b)(5), 416.904, and 416.912(b)(5)).
    The reason that a decision awarding disability benefits for the 
Railroad Retirement Board sometimes applies to Social Security 
disability benefits is that there is a law that permits this 
presumption. Also, the determinations of disability that we accept use 
the same standard that we use for determining disability under our 
programs; in some cases, we make the determination of disability that 
the Railroad Retirement Board uses.
    Comment: One commenter suggested that hepatitis C should be a 
category for SSA disability at the point of diagnosis, stating that 
genotyping and treatment costs are prohibitive. This commenter stated 
that there was no help for those in the interim between contracting the 
disease and being near death under the current standards, and those 
individuals must go without any assistance for years until they meet 
the criteria in the chronic liver disease listings.
    Another commenter noted that the symptoms of hepatitis C virus 
infection make learning a new, less strenuous trade an unrealistic 
option if an individual does not become symptomatic until later in 
life.
    Response: While we understand the concern of the first commenter, 
we do not have the authority to do what the commenter asked. To qualify 
for Social Security Disability Insurance or Supplemental Security 
Income benefits, individuals must show that they are disabled under the 
definition of disability in the Act.
    Likewise, with regard to the second comment, we cannot pay 
disability benefits under the Act to individuals who are not currently 
disabled but who may become disabled in the future. However, at the 
fifth step of our sequential evaluation process (described near the end 
of this preamble) we do consider an individual's age, education, and 
work experience. At this step, the older an individual becomes, the 
more likely it is that we will find the individual unable to make an 
adjustment to other work; that is, the more likely we will find that 
the individual is disabled.
    Comment: One commenter recommended that we include a reference to 
hepatitis B under recurrent and persistent syndromes because chronic 
fatigue syndrome (CFS) and depression are common symptoms and these 
functional limitations are debilitating and prevalent enough that they 
merit inclusion.
    Response: We did not adopt this comment but we did provide guidance 
on hepatitis B in final 5.00D4b and 105.00D4b. We did not include a 
reference to CFS in this final rule partly because it is a diagnosis of 
exclusion; that is, the diagnosis is not made if another physical or 
mental impairment, such as hepatitis, is present that can account for 
the symptoms. We explain our policy for evaluating CFS in Social 
Security Ruling 99-2p, ``Titles II and XVI: Evaluating Cases Involving 
Chronic Fatigue Syndrome (CFS),'' 83 FR 23380 (April 30, 1999).\3\
---------------------------------------------------------------------------

    \3\ The ruling is also available at http://www.socialsecurity.gov/OP_Home/rulings/di/01/SSR99=02=di=01.html.
---------------------------------------------------------------------------

    Comment: Many commenters stated that individuals undergoing 
interferon/ribavirin treatment for hepatitis C cannot work as the 
treatment seriously interferes with physical and mental stamina. One 
commenter observed that it was unfair to patients and employers to 
expect those who are undergoing treatment for hepatitis C to work due 
to the side effects of the treatment. They asked us to use compassion 
when we make decisions regarding changes in the chronic liver disease 
criteria. Another commenter stated that disability benefits would be 
helpful for patients when going through treatment or transplant as the 
symptoms attack on all fronts.
    Response: Partly in response to these comments, we included 
guidance in final 5.00D4 and 105.00D4 about the types of treatment for 
hepatitis C, including interferon/ribavirin treatment for adults and 
children, and the common adverse effects of treatment. However, we 
cannot automatically grant disability benefits if an individual is 
undergoing treatment for hepatitis B or C. Everyone reacts differently 
to the treatment and we must evaluate the disease progression, side 
effects of treatment, and response to treatment on an individual basis, 
unless in the future we can identify a diagnostic technique that would 
allow us to use a conclusive presumption that a case of hepatitis is so 
severe the individual cannot, as a practical matter, engage in any 
gainful activity.
    Comment: Some commenters suggested that we should include

[[Page 59418]]

neuropsychological testing in the evaluation of any person seeking 
Social Security disability benefits for chronic liver disease, 
regardless of liver histology, because 50 percent of individuals with 
chronic hepatitis C experience cognitive impairment and chronic 
fatigue, even in individuals with mild liver disease.
    Response: We did not adopt the comment. Neuropsychological testing 
is highly specialized, and we generally try to exhaust all other or 
more direct avenues before we purchase such testing. Also, the testing 
examines fine areas of brain functioning and not the global functioning 
that we are generally most interested in for our disability 
evaluations.
    Comment: Several commenters suggested that the medical criteria be 
kept in line with the National Institutes of Health (NIH) Consensus 
Statement on the Management of Hepatitis C (the Consensus 
Statement).\4\
---------------------------------------------------------------------------

    \4\ http://consensus.nih.gov/2002/2002HepatitisC2002116PDF.pdf.
---------------------------------------------------------------------------

    Response: With the additional material we added as described above, 
we believe that these final rules are consistent with the Consensus 
Statement to the extent appropriate for our disability evaluation 
criteria under the listings. There is a considerable amount of 
information in the Consensus Statement that is not specifically 
relevant to our disability adjudications (for example, discussion of 
treatment options and recommendations for more education and research) 
or that goes beyond what is appropriate to include in our listings.

Listings 5.06 and 105.06 Inflammatory Bowel Disease

    Comment: We received many comments about IBD. Some commenters were 
concerned that the listings focused on recurrent intestinal obstruction 
or fistulae as practically the only criteria for disability due to IBD. 
The commenters agreed that most individuals with IBD respond to medical 
or surgical treatment and lead fairly normal lives, but they indicated 
that there is a subset of individuals who have recurring and persisting 
disease that is refractory to treatment and makes them unable to work. 
The commenters suggested that many of these individuals would not be 
covered by the proposed listings and would face difficulty with their 
claims.
    The commenters indicated that individuals with IBD can be 
incapacitated by persistent abdominal pain that may be unassociated 
with either obstruction or fistulae. They also said that profound 
fatigue due to the underlying inflammatory disease or the resulting and 
often complex nutritional deficiencies that accompany these disorders 
may be incapacitating. The commenters mentioned several symptoms and 
signs that could be refractory to medical and surgical treatment; for 
example, recurrent obstruction, anemia, fistulae, abscess, or other 
perineal or intra-abdominal complications. They also noted that 
recurrent and persisting severe diarrhea, with or without incontinence, 
makes it impossible for many individuals with IBD to sustain any 
activity for even modest periods of time. One of the commenters stated 
that many of the most challenging symptoms of IBD cannot be directly 
quantified by the usual objective studies, including imaging or 
laboratory tests, resulting in our excluding relief to many who need 
and deserve it.
    Another commenter stated that we did not sufficiently address 
recurrent diarrhea and bowel incontinence that do not lead to weight 
loss or malnutrition. This commenter noted that these conditions may 
require proximity to a restroom or may interfere with the ability to 
work in public. The commenter acknowledged that they are ``probably 
not'' listings issues, but said that there did not appear to be 
sufficient guidance for disability adjudicators on how to consider 
these issues.
    Two individuals who have IBD and who had filed claims for 
disability benefits described how profound the disease was for them and 
expressed concern about any changes we might make that would make it 
more difficult to qualify. One of these commenters, who has Crohn's 
disease, described the embarrassment of the disease and the other kinds 
of illnesses she has had that are associated with the disease and its 
treatment. The other commenter said that he was against any change in 
our present regulations that would make it more difficult for a person 
with IBD to qualify for disability benefits. He said that the proposed 
changes would cause an added hardship for individuals with IBD.
    Response: We adopted most of the comments and completely revised 
proposed listings 5.06 and 105.06 and the introductory text for IBD. In 
response to these comments, we added final 5.00E in the introductory 
text in part A and revised and expanded proposed 105.00F4 (final 
105.00E) in part B to provide more detailed guidance for documenting 
and evaluating IBD in adults and children. We also added criteria in 
final listings 5.06 and 105.06 to include some of the other 
manifestations of IBD mentioned by the commenters.
    The new sections in the introductory text include most of the 
examples of symptoms and signs of IBD that the commenters mentioned, as 
well as others that the commenters did not specifically mention, 
including a longer list of potential manifestations in other body 
systems than we included under the prior listings. In addition, we 
revised proposed listings 5.06 and 105.06 by adding a list of six 
manifestations in paragraph B of final listing 5.06 and a list of five 
manifestations in paragraph B of final listing 105.06.
    We did not include criteria for manifestations like severe diarrhea 
or fecal incontinence. We believe that the effect of severe diarrhea is 
best identified at the listing level by the criteria in 5.06B1 and 
105.06B1 (anemia with a hemoglobin of less than 10 g/dL) and 5.06B2 and 
105.06B2 (serum albumin of 3.0g/dL or less). We agree that there are 
other consequences of severe diarrhea or fecal incontinence, such as 
the necessity to be near a restroom or the difficulty of sustaining 
activities for even modest amounts of time, that may significantly 
affect an individual's ability to work or a child's ability to function 
in an age-appropriate manner. However, we believe these consequences of 
IBD are more appropriately addressed on an individual case basis when 
we assess residual functional capacity or functional equivalence.
    In considering these comments, we also noted that there were 
unintentional differences between proposed listings 5.06B and 105.06B, 
and that we included proposed 105.00F4 (final 105.00E) specifically for 
children but no corresponding guidance in proposed part A for adults. 
In making the revisions in the final rules, we determined that, with 
minor exceptions, there was no need for the information in part A to be 
different from the information in part B. Therefore, we added final 
5.00E to correspond to final 105.00E, and we made a number of editorial 
changes to 105.00E for consistency between the two sections. Final 
5.00E and 105.00E and final listings 5.06 and 105.06 are the same, 
except for the minor differences necessary to address childhood 
disability that we have already noted in the explanations of the final 
rules at the beginning of this preamble.
    With regard to the last comments expressing concern that our 
changes may make it more difficult for individuals with IBD to qualify 
for disability benefits, we believe that the

[[Page 59419]]

changes we are making in these final rules are an improvement over the 
proposed rules that address many of the commenters' concerns. Also, the 
final rules are consistent with advances in medical science and 
technology, our adjudicative experience, and our goal of appropriately 
finding all individuals who are unable to perform any gainful activity 
disabled under the listings.
    Comment: One commenter stated that he was ``perplexed'' by the 
statement in the preamble to the NPRM that ``anemia, when caused by 
inflammatory bowel disease, is not an appropriate indicator of listing-
level severity.'' (See 66 FR at 57013.) The commenter noted that we 
have long held that chronic anemia with persistent hematocrit below 30 
percent is of listing-level severity. The commenter asserted that 
people with chronic anemia are tired, fatigued, and have poor stamina, 
and that there are other factors that affect their ability to function.
    Another commenter stated that our proposed reasons for changes to 
the listing were inaccurate. The commenter questioned our statement 
that ``a gradual reduction in hemoglobin, even to very low levels, is 
often well tolerated and does not correlate with ability to function.'' 
(See 66 FR at 57013.) The commenter stated that studies show that 
quality of life and functional status correlate with hemoglobin levels.
    Response: It is true that we have long had listings that are met 
with anemia demonstrated by hematocrits of 30 percent or less. We also 
agree that anemia may cause the kinds of symptoms listed. However, 
listing criteria must represent a level of severity that prevents ``any 
gainful activity.'' We cannot presume, based only on low hematocrit (or 
hemoglobin) levels, that the symptoms referred to will be present or 
sufficiently severe in all cases to determine that an individual is 
disabled. The body adapts to a gradual lowering of hematocrit (or 
hemoglobin) levels, therefore there is not a strong correlation between 
hematocrit levels and the ability to function. We removed a similar 
criterion from the genitourinary system listings for the same reason. 
See 70 FR 38582, 38586 (2005).
    However, we have included a criterion for anemia with hemoglobin of 
less than 10 g/dL as one of the criteria of final listings 5.06B and 
105.06B. We believe that it is an appropriate criterion when it occurs 
in conjunction with at least one of the other manifestations of IBD 
listed in the final rules. We are using hemoglobin (measured in units 
of g/dL) rather than hematocrit (percent) in assessing the degree of 
anemia as the former laboratory measurement is more accurate.

Listing 5.08 Weight Loss Due to Any Digestive Disorder

    Comment: A commenter suggested that we include guidance that height 
be measured without shoes in the introductory text to the listings. 
Another commenter noted that, although we explained in the NPRM how to 
round inches and centimeters, we did not explain how to round pounds 
and kilograms.
    Response: We adopted the first comment. Because the final listings 
are based on BMI, we now explain in final 5.00G2a that measurements of 
both weight and height must be made without shoes.
    We did not need to adopt the second comment because we changed the 
weight loss criteria to BMI measurements and as a consequence removed 
the proposed rule for rounding. Because of this change, we also did not 
include the height and weight tables from proposed listing 5.08.
    Comment: Two commenters believed that the height and weight tables 
in the regulations did not reflect the chronicity and severity of 
disease in individuals with IBD who are routinely treated with 
corticosteroids. The commenters indicated that corticosteroids lead to 
substantial salt and water retention and increased fatty tissue 
accumulation, so that nutritionally depleted patients may have 
artificially sustained weight. They also noted that it is not uncommon 
for patients with crippling symptoms, hypoalbuminemia, and nutritional 
deficiencies to have ``normal'' or increased weight due to the 
corticosteroids.
    Response: We agree with the commenters that individuals with IBD 
may have ``normal'' weight; however, final listing 5.08 is specifically 
for individuals with weight loss as a consequence of a digestive 
disorder. Individuals whose impairments do not meet listing 5.08 may 
still meet the criteria of another listing. As we explained earlier, we 
have significantly expanded final listings 5.06 and 105.06 to include 
criteria for many of the symptoms and signs of IBD. For example, we 
have included criteria in final 5.06B1 and B8 under which individuals 
with IBD who are nutritionally depleted but have sustained weight may 
qualify. Also in response to these comments, we have provided examples 
in final 5.00E2 and 105.00E2 of signs and laboratory findings that may 
demonstrate malnutrition in the absence of weight loss, such as edema, 
anemia, hypoalbuminemia, hypokalemia, hypocalcemia, and hypomagnesemia. 
If the impairment does not meet or medically equal a listing, we will 
continue our evaluation through the sequential evaluation process.

Listing 105.08 Malnutrition

    Comment: Two commenters suggested that we move the guidelines for 
what is needed to document malnutrition from proposed 105.00F of the 
introductory text into listing 105.08 because they were so specific.
    Response: We adopted the comments and included three of the 
proposed examples as criteria in final listing 105.08A. We did not 
include the example of steatorrhea for reasons we have already 
explained. Also, as explained earlier, we changed the criteria in final 
105.08A1 for anemia to a hemoglobin of less than 10.0 g/dL.
    Comment: One commenter suggested that we specify that we use the 
most current edition when we refer to the CDC chart in listing 105.08 
and in the introductory text. This would ensure that the listing 
criteria continue to reflect the latest guidance.
    Response: We adopted the comment. The change appears in final 
105.00G2 and in final listings 105.08B1 and B2.

Listings 5.09 and 105.09

    Comment: One commenter suggested that as long as an individual is 
required to take anti-rejection drugs after a transplanted organ, at 
the very least, medical benefits should continue.
    Response: We did not adopt this comment because we do not have the 
authority to do what the commenter asked. We can only pay benefits to 
individuals who are under a disability as defined in the Act and our 
regulations, and Medicare and Medicaid benefits generally depend on 
continuing entitlement to disability benefits.
    Comment: One commenter stated that disability benefits should last 
for 18 months after a liver transplant because transplants do not 
remedy the underlying cause of the disease, such as viral hepatitis.
    Response: We did not adopt this comment because in our experience 
12 months is a sufficient period after which we need to reevaluate each 
individual's status to see if he or she is still disabled. This is the 
period we provide for most other transplants. See, for example, 
listings 3.11 (lung), 4.09 (heart), 6.02 (kidney), 7.17 (aplastic 
anemia with bone marrow or stem cell transplantation), and 13.05 
(lymphoma with bone marrow or stem cell transplantation). Also, we 
published the

[[Page 59420]]

liver transplant listing in 2002 in another notice; these final rules 
do not make any substantive changes to that rule, only editorial 
revisions. And as we have already noted, the 1-year rule does not mean 
that an individual's disability automatically ends 1 year after the 
transplant. Our rule is only that after 1 year we generally will 
consider whether the individual is still disabled. Our existing rules 
also allow our adjudicators to set a later diary date for review of 
continuing disability if the facts of the case warrant it.

Other Comments

    Comment: One commenter did not support our proposal to remove 
reference listings. The commenter believed that it is easier for our 
adjudicators to recognize the need to document and evaluate an 
impairment if it is also included in the listing itself. The commenter 
also noted that reference listings assure the public and their 
physicians that a specific impairment has been considered.
    Response: We did not adopt the comment. With one exception, all of 
the reference listings in the part A digestive disorder listings were 
to listing 5.08, the listing for weight loss. We believe that our 
adjudicators, the public, and their physicians will easily see that 
final listing 5.08 is applicable to weight loss due to any digestive 
disorder. The only exception in part A was for hepatic encephalopathy, 
which cross-referred to listing 12.02; however, we have now added a 
listing specifically for hepatic encephalopathy (final listing 5.05F) 
in the digestive disorders listings. Part B was essentially the same, 
with most reference listings cross-referring to listing 105.08, and a 
reference listing for hepatic encephalopathy, which we now list in 
final listing 105.05F. Prior listing 105.07C also referred to growth 
impairment listing 100.03. We are removing that reference listing 
without replacement; however, as we have already noted, we have added 
references to growth impairment in the introductory text to these 
listings and we believe that this is sufficient.
    We do not agree that the prior reference listings were especially 
helpful to adjudicators. All individuals who would qualify under any of 
the provisions of our prior reference listings will continue to qualify 
under other listings or the rules for medical or functional equivalence 
for children. Also, because reference listings are redundant, we are 
removing them from all the body systems as we revise them; therefore, 
we would be inconsistent if we retained reference listings only in this 
body system. Our adjudicators are aware that the listings do not 
include all possible disabling impairments, so they review all of the 
evidence, including the claimant's allegations and the medical evidence 
from treating and other medical sources, to identify the impairments 
they must evaluate.
    Comment: One commenter suggested that we include some discussion in 
the introductory text of how to evaluate digestive impairments for 
which there is no specific listing, such as peptic ulcer disease and 
chronic pancreatitis.
    Response: We did not add specific information in the introductory 
text about peptic ulcer disease or chronic pancreatitis because we 
prefer to include information that is relevant to the application of 
these listings. However, we do make it clear that we may evaluate 
digestive disorders that are not specifically named in the introductory 
text under this body system.
    Comment: One commenter asked that we consider the unique health 
risks and cultural issues that affect Asian Americans and immigrant 
communities.
    Response: We did not adopt the comment. We are not aware of any 
current medical distinction that supports the suggestion.

Additional Information

What programs do these final rules affect?

    These final rules affect disability determinations and decisions 
that we make under title II and title XVI of the Act. In addition, to 
the extent that Medicare entitlement and Medicaid eligibility are based 
on whether you qualify for disability benefits under title II or title 
XVI, these final rules 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 (see 
Sec.  404.336) of insured individuals.
    Under title XVI of the Act, we provide for Supplemental Security 
Income (SSI) payments on the basis of disability if you are disabled 
and 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 is 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
 If you file a claim under . .  And you are . . .       determinable
               .                                      impairment(s) as
                                                    described above that
                                                      results in . . .
------------------------------------------------------------------------
title II......................  an adult or a      the inability to do
                                 child.             any substantial
                                                    gainful activity
                                                    (SGA).
title XVI.....................  an individual age  the inability to do
                                 18 or older.       any SGA.
title XVI.....................  an individual      marked and severe
                                 under age 18.      functional
                                                    limitations.
------------------------------------------------------------------------

How do we decide whether you are disabled?

    To decide whether you are disabled under the Act, we use a five-
step ``sequential evaluation process,'' which we describe in our 
regulations at Sec. Sec.  404.1520 and 416.920. We follow the five 
steps in order and stop as soon as we can make a determination or 
decision. The steps are:
    1. Are you working, and is the work you are doing substantial 
gainful activity? If you are working and the work you are doing is 
substantial gainful activity, we will find that you are not disabled, 
regardless of your medical condition or your age, education, and work 
experience. If you are not, we will go on to step 2.
    2. Do you have a ``severe'' impairment? If you do not have an 
impairment or combination of impairments that significantly limits your 
physical or mental ability to do basic work activities, we will find 
that you are not disabled. If you do, we will go on to step 3.
    3. Do you have an impairment(s) that meets or medically equals the 
severity of an impairment in the listings? If you do, and the 
impairment(s) meets the duration requirement, we will find that

[[Page 59421]]

you are disabled. If you do not, we will go on to step 4.
    4. Do you have the residual functional capacity to do your past 
relevant work? If you do, we will find that you are not disabled. If 
you do not, we will go on to step 5.
    5. Does your impairment(s) prevent you from doing any other work 
that exists in significant numbers in the national economy, considering 
your residual functional capacity, age, education, and work experience? 
If it does, and it meets the duration requirement, we will find that 
you are disabled. If it does not, we will find that you are not 
disabled.
    We use a different sequential evaluation process for children who 
apply for payments based on disability under SSI. If you are already 
receiving benefits, we also use a different sequential evaluation 
process when we decide whether your disability continues. See 
Sec. Sec.  404.1594, 416.924, 416.994, and 416.994a of our regulations. 
However, all of these processes also include steps at which we consider 
whether your impairment meets or medically equals one of our listings.

What are the listings?

    The listings are examples of impairments that we consider severe 
enough to prevent you as an adult from doing any gainful activity. If 
you are a child seeking SSI payments based on disability, the listings 
describe impairments that we consider severe enough to result in marked 
and severe functional limitations. Although the listings are contained 
only in appendix 1 to subpart P of part 404 of our regulations, we 
incorporate them by reference in the SSI program in Sec.  416.925 of 
our regulations, and apply them to claims under both title II and title 
XVI of the Act.

How do we use the listings?

    The listings are in two parts. There are listings for adults (part 
A) and for children (part B). If you are an individual age 18 or over, 
we apply the listings in part A when we assess your claim, and we never 
use the listings in part B.
    If you are an individual under age 18, we first use the criteria in 
part B of the listings. Part B contains criteria that apply only to 
individuals who are under age 18. If your impairment does not meet the 
criteria in part B, we may then use the criteria in part A when those 
criteria give appropriate consideration to the effects of the 
impairment(s) in children. (See Sec. Sec.  404.1525 and 416.925.)
    If your impairment(s) does not meet any listing, we will also 
consider whether it medically equals any listing; that is, whether it 
is as medically severe as an impairment in the listings. (See 
Sec. Sec.  404.1526 and 416.926.)

What if you do not have an impairment(s) that meets or medically equals 
a listing?

    We use the listings only to decide that you are disabled or that 
you are still disabled. We will not deny your claim or decide that you 
no longer qualify for benefits because your impairment(s) does not meet 
or medically equal a listing. If you are not working and you have a 
severe impairment(s) that does not meet or medically equal any listing, 
we may still find you disabled based on other rules in the sequential 
evaluation process that we use to evaluate all disability claims. 
Likewise, we will not decide that your disability has ended only 
because your impairment(s) does not meet or medically equal a listing.
    Also, when we conduct reviews to determine whether your disability 
continues, we will not find that your disability has ended because we 
have changed a listing. Our regulations explain that, when we change 
our listings, we continue to use our prior listings when we review your 
case, if you qualified for disability benefits or SSI payments based on 
our determination or decision that your impairment(s) met or medically 
equaled a listing. 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 condition(s) has 
medically improved so that you no longer meet or medically equal the 
prior listing, we evaluate your case further to determine whether you 
are currently disabled. We may find that you are currently disabled, 
depending on the full circumstances of your case. See Sec. Sec.  
404.1594(c)(3)(i) and 416.994(b)(2)(iv)(A). If you are a child who is 
eligible for SSI payments, we follow a similar rule after we decide 
that you have experienced medical improvement in your condition(s). See 
Sec.  416.994a(b)(2).

What is our authority to make rules and set procedures for determining 
whether a person is disabled under the statutory definition?

    Section 205(a) of the Act and, by reference to section 205(a), 
section 1631(d)(1) provide that:

    The Commissioner of Social Security shall have full power and 
authority to make rules and regulations and to establish procedures, 
not inconsistent with the provisions of this title, which are 
necessary or appropriate to carry out such provisions, and shall 
adopt reasonable and proper rules and regulations to regulate and 
provide for the nature and extent of the proofs and evidence and the 
method of taking and furnishing the same in order to establish the 
right to benefits hereunder.

Regulatory Procedures

Executive Order 12866

    We have consulted with the Office of Management and Budget (OMB) 
and determined that these final rules meet the criteria for a 
significant regulatory action under Executive Order 12866, as amended. 
Thus, they were subject to OMB review.
    Our proposed rules met the criteria for an economically significant 
regulatory action under Executive Order 12866. They were also ``major'' 
rules under 5 U.S.C. 801ff. For the reasons stated earlier in this 
preamble, these final rules reflect changes we have made from the 
proposed rules. Based on these changes, we estimate that these final 
rules will result in program savings but will not constitute an 
economically significant regulatory action or ``major'' rules.
    We are projecting savings in program expenditures as described 
below.
Program Savings
1. Title II
    We estimate that these final rules would result in reduced program 
outlays resulting in the following savings (in millions of dollars) to 
the title II program ($132 million total in a 5-year period beginning 
in FY 2008).

----------------------------------------------------------------------------------------------------------------
     FY 2008            FY 2009            FY 2010            FY 2011            FY 2012             Total
----------------------------------------------------------------------------------------------------------------
           -$10               -$19               -$27               -$35               -$42          -$132 \5\
----------------------------------------------------------------------------------------------------------------
\5\ 5-year total may not be equal to the sum of the annual totals due to rounding.


[[Page 59422]]

2. Title XVI
    We estimate that these final rules will result in reduced program 
outlays resulting in the following savings (in millions of dollars) to 
the SSI program ($25 million in a 5-year period beginning in FY 2008).

----------------------------------------------------------------------------------------------------------------
     FY 2008            FY 2009            FY 2010            FY 2011            FY 2012             Total
----------------------------------------------------------------------------------------------------------------
            -$1                -$3                -$5                -$8                -$8          -$25 \6\
----------------------------------------------------------------------------------------------------------------
\6\ Federal SSI payments due on October 1st in fiscal year 2012 are included with payments for the prior fiscal
  year.

Regulatory Flexibility Act

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

Paperwork Reduction Act

    The Paperwork Reduction Act (PRA) of 1995 says that no persons are 
required to respond to a collection of information unless it displays a 
valid OMB control number. In accordance with the PRA, SSA is providing 
notice that OMB has approved the information collection requirements 
contained in Part A, 5.00 and Part B, 105.00 of these final rules. The 
OMB Control Number for this collection is 0960-0642 expiring March 31, 
2008.

(Catalog of Federal Domestic 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

20 CFR Part 404

    Administrative practice and procedure, Death benefits, Blind, 
Disability benefits, Old-age, survivors, and disability insurance, 
Reporting and recordkeeping requirements, Social Security.

20 CFR Part 416

    Administrative practice and procedure, Aged, Blind, Disability 
benefits, Public assistance programs, Reporting and recordkeeping 
requirements, Supplemental Security Income (SSI).

    Dated: June 25, 2007.
Michael J. Astrue,
Commissioner of Social Security.

0
For the reasons set forth in the preamble, subpart P of part 404 and 
subpart I of part 416 of chapter III of title 20 of the Code of Federal 
Regulations are amended as set forth below:

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

0
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 902(a)(5)); sec. 211(b), Pub. L. 104-193, 110 
Stat. 2105, 2189; sec. 202, Pub. L. 108-203, 118 Stat. 509 (42 
U.S.C. 902 note).

Appendix 1 to Subpart P of Part 404--Listing of Impairments [Amended]

0
2. Revise item 6 of the introductory text before part A of appendix 1 
to subpart P of part 404 to read as follows:

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

* * * * *
    6. Digestive System (5.00 and 105.00): October 19, 2012.
* * * * *

0
3. Revise section 5.00 in part A of appendix 1 to subpart P of part 404 
to read as follows:

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

* * * * *

Part A

* * * * *

5.00 DIGESTIVE SYSTEM

    A. What kinds of disorders do we consider in the digestive 
system? Disorders of the digestive system include gastrointestinal 
hemorrhage, hepatic (liver) dysfunction, inflammatory bowel disease, 
short bowel syndrome, and malnutrition. They may also lead to 
complications, such as obstruction, or be accompanied by 
manifestations in other body systems.
    B. What documentation do we need? We need a record of your 
medical evidence, including clinical and laboratory findings. The 
documentation should include appropriate medically acceptable 
imaging studies and reports of endoscopy, operations, and pathology, 
as appropriate to each listing, to document the severity and 
duration of your digestive disorder. Medically acceptable imaging 
includes, but is not limited to, x-ray imaging, sonography, 
computerized axial tomography (CAT scan), magnetic resonance imaging 
(MRI), and radionuclide scans. Appropriate means that the technique 
used is the proper one to support the evaluation and diagnosis of 
the disorder. The findings required by these listings must occur 
within the period we are considering in connection with your 
application or continuing disability review.
    C. How do we consider the effects of treatment?
    1. Digestive disorders frequently respond to medical or surgical 
treatment; therefore, we generally consider the severity and 
duration of these disorders within the context of prescribed 
treatment.
    2. We assess the effects of treatment, including medication, 
therapy, surgery, or any other form of treatment you receive, by 
determining if there are improvements in the symptoms, signs, and 
laboratory findings of your digestive disorder. We also assess any 
side effects of your treatment that may further limit your 
functioning.
    3. To assess the effects of your treatment, we may need 
information about:
    a. The treatment you have been prescribed (for example, the type 
of medication or therapy, or your use of parenteral (intravenous) 
nutrition or supplemental enteral nutrition via a gastrostomy);
    b. The dosage, method, and frequency of administration;
    c. Your response to the treatment;
    d. Any adverse effects of such treatment; and
    e. The expected duration of the treatment.
    4. Because the effects of treatment may be temporary or long-
term, in most cases we need information about the impact of your 
treatment, including its expected duration and side effects, over a 
sufficient period of time to help us assess its outcome. When 
adverse effects of treatment contribute to the severity of your 
impairment(s), we will consider the duration or expected duration of 
the treatment when we assess the duration of your impairment(s).
    5. If you need parenteral (intravenous) nutrition or 
supplemental enteral nutrition via a gastrostomy to avoid 
debilitating complications of a digestive disorder, this treatment 
will not, in itself, indicate that you are unable to do any gainful 
activity, except under 5.07, short bowel syndrome (see 5.00F).
    6. If you have not received ongoing treatment or have not had an 
ongoing relationship with the medical community despite the 
existence of a severe impairment(s), we will evaluate the severity 
and duration of your digestive impairment on the basis of the 
current medical and other evidence in your case record. If you have 
not received treatment, you may not be able to show an impairment 
that meets the criteria of one of the digestive system listings, but 
your digestive impairment may medically

[[Page 59423]]

equal a listing or be disabling based on consideration of your 
residual functional capacity, age, education, and work experience.
    D. How do we evaluate chronic liver disease?
    1. General. Chronic liver disease is characterized by liver cell 
necrosis, inflammation, or scarring (fibrosis or cirrhosis), due to 
any cause, that persists for more than 6 months. Chronic liver 
disease may result in portal hypertension, cholestasis (suppression 
of bile flow), extrahepatic manifestations, or liver cancer. (We 
evaluate liver cancer under 13.19.) Significant loss of liver 
function may be manifested by hemorrhage from varices or portal 
hypertensive gastropathy, ascites (accumulation of fluid in the 
abdominal cavity), hydrothorax (ascitic fluid in the chest cavity), 
or encephalopathy. There can also be progressive deterioration of 
laboratory findings that are indicative of liver dysfunction. Liver 
transplantation is the only definitive cure for end stage liver 
disease (ESLD).
    2. Examples of chronic liver disease include, but are not 
limited to, chronic hepatitis, alcoholic liver disease, non-
alcoholic steatohepatitis (NASH), primary biliary cirrhosis (PBC), 
primary sclerosing cholangitis (PSC), autoimmune hepatitis, 
hemochromatosis, drug-induced liver disease, Wilson's disease, and 
serum alpha-1 antitrypsin deficiency. Acute hepatic injury is 
frequently reversible, as in viral, drug-induced, toxin-induced, 
alcoholic, and ischemic hepatitis. In the absence of evidence of a 
chronic impairment, episodes of acute liver disease do not meet 
5.05.
    3. Manifestations of chronic liver disease.
    a. Symptoms may include, but are not limited to, pruritis 
(itching), fatigue, nausea, loss of appetite, or sleep disturbances. 
Symptoms of chronic liver disease may have a poor correlation with 
the severity of liver disease and functional ability.
    b. Signs may include, but are not limited to, jaundice, 
enlargement of the liver and spleen, ascites, peripheral edema, and 
altered mental status.
    c. Laboratory findings may include, but are not limited to, 
increased liver enzymes, increased serum total bilirubin, increased 
ammonia levels, decreased serum albumin, and abnormal coagulation 
studies, such as increased International Normalized Ratio (INR) or 
decreased platelet counts. Abnormally low serum albumin or elevated 
INR levels indicate loss of synthetic liver function, with increased 
likelihood of cirrhosis and associated complications. However, other 
abnormal lab tests, such as liver enzymes, serum total bilirubin, or 
ammonia levels, may have a poor correlation with the severity of 
liver disease and functional ability. A liver biopsy may demonstrate 
the degree of liver cell necrosis, inflammation, fibrosis, and 
cirrhosis. If you have had a liver biopsy, we will make every 
reasonable effort to obtain the results; however, we will not 
purchase a liver biopsy. Imaging studies (CAT scan, ultrasound, MRI) 
may show the size and consistency (fatty liver, scarring) of the 
liver and document ascites (see 5.00D6).
    4. Chronic viral hepatitis infections.
    a. General.
    (i) Chronic viral hepatitis infections are commonly caused by 
hepatitis C virus (HCV), and to a lesser extent, hepatitis B virus 
(HBV). Usually, these are slowly progressive disorders that persist 
over many years during which the symptoms and signs are typically 
nonspecific, intermittent, and mild (for example, fatigue, 
difficulty with concentration, or right upper quadrant pain). 
Laboratory findings (liver enzymes, imaging studies, liver biopsy 
pathology) and complications are generally similar in HCV and HBV. 
The spectrum of these chronic viral hepatitis infections ranges 
widely and includes an asymptomatic state; insidious disease with 
mild to moderate symptoms associated with fluctuating liver tests; 
extrahepatic manifestations; cirrhosis, both compensated and 
decompensated; ESLD with the need for liver transplantation; and 
liver cancer. Treatment for chronic viral hepatitis infections 
varies considerably based on medication tolerance, treatment 
response, adverse effects of treatment, and duration of the 
treatment. Comorbid disorders, such as HIV infection, may affect the 
clinical course of viral hepatitis infection(s) or may alter the 
response to medical treatment.
    (ii) We evaluate all types of chronic viral hepatitis infections 
under 5.05 or any listing in an affected body system(s). If your 
impairment(s) does not meet or medically equal a listing, we will 
consider the effects of your hepatitis when we assess your residual 
functional capacity.
    b. Chronic hepatitis B virus (HBV) infection.
    (i) Chronic HBV infection is diagnosed by the detection of 
hepatitis B surface antigen (HBsAg) in the blood for at least 6 
months. In addition, detection of the hepatitis B envelope antigen 
(HBeAg) suggests an increased likelihood of progression to cirrhosis 
and ESLD.
    (ii) The therapeutic goal of treatment is to suppress HBV 
replication and thereby prevent progression to cirrhosis and ESLD. 
Treatment usually includes a combination of interferon injections 
and oral antiviral agents. Common adverse effects of treatment are 
the same as noted in 5.00D4c(ii) for HCV, and generally end within a 
few days after treatment is discontinued.
    c. Chronic hepatitis C virus (HCV) infection.
    (i) Chronic HCV infection is diagnosed by the detection of 
hepatitis C viral RNA in the blood for at least 6 months. 
Documentation of the therapeutic response to treatment is also 
monitored by the quantitative assay of serum HCV RNA (``HCV viral 
load''). Treatment usually includes a combination of interferon 
injections and oral ribavirin; whether a therapeutic response has 
occurred is usually assessed after 12 weeks of treatment by checking 
the HCV viral load. If there has been a substantial reduction in HCV 
viral load (also known as early viral response, or EVR), this 
reduction is predictive of a sustained viral response with 
completion of treatment. Combined therapy is commonly discontinued 
after 12 weeks when there is no early viral response, since in that 
circumstance there is little chance of obtaining a sustained viral 
response (SVR). Otherwise, treatment is usually continued for a 
total of 48 weeks.
    (ii) Combined interferon and ribavirin treatment may have 
significant adverse effects that may require dosing reduction, 
planned interruption of treatment, or discontinuation of treatment. 
Adverse effects may include: Anemia (ribavirin-induced hemolysis), 
neutropenia, thrombocytopenia, fever, cough, fatigue, myalgia, 
arthralgia, nausea, loss of appetite, pruritis, and insomnia. 
Behavioral side effects may also occur. Influenza-like symptoms are 
generally worse in the first 4 to 6 hours after each interferon 
injection and during the first weeks of treatment. Adverse effects 
generally end within a few days after treatment is discontinued.
    d. Extrahepatic manifestations of HBV and HCV. In addition to 
their hepatic manifestations, both HBV and HCV may have significant 
extrahepatic manifestations in a variety of body systems. These 
include, but are not limited to: Keratoconjunctivitis (sicca 
syndrome), glomerulonephritis, skin disorders (for example, lichen 
planus, porphyria cutanea tarda), neuropathy, and immune dysfunction 
(for example, cryoglobulinemia, Sj[ouml]gren's syndrome, and 
vasculitis). The extrahepatic manifestations of HBV and HCV may not 
correlate with the severity of your hepatic impairment. If your 
impairment(s) does not meet or medically equal a listing in an 
affected body system(s), we will consider the effects of your 
extrahepatic manifestations when we assess your residual functional 
capacity.
    5. Gastrointestinal hemorrhage (5.02 and 5.05A). 
Gastrointestinal hemorrhaging can result in hematemesis (vomiting of 
blood), melena (tarry stools), or hematochezia (bloody stools). 
Under 5.02, the required transfusions of at least 2 units of blood 
must be at least 30 days apart and occur at least three times during 
a consecutive 6-month period. Under 5.05A, hemodynamic instability 
is diagnosed with signs such as pallor (pale skin), diaphoresis 
(profuse perspiration), rapid pulse, low blood pressure, postural 
hypotension (pronounced fall in blood pressure when arising to an 
upright position from lying down) or syncope (fainting). 
Hemorrhaging that results in hemodynamic instability is potentially 
life-threatening and therefore requires hospitalization for 
transfusion and supportive care. Under 5.05A, we require only one 
hospitalization for transfusion of at least 2 units of blood.
    6. Ascites or hydrothorax (5.05B) indicates significant loss of 
liver function due to chronic liver disease. We evaluate ascites or 
hydrothorax that is not attributable to other causes under 5.05B. 
The required findings must be present on at least two evaluations at 
least 60 days apart within a consecutive 6-month period and despite 
continuing treatment as prescribed.
    7. Spontaneous bacterial peritonitis (5.05C) is an infectious 
complication of chronic liver disease. It is diagnosed by ascitic 
peritoneal fluid that is documented to contain an absolute 
neutrophil count of at least 250 cells/mm3. The required 
finding in 5.05C is satisfied with one evaluation documenting

[[Page 59424]]

peritoneal fluid infection. We do not evaluate other causes of 
peritonitis that are unrelated to chronic liver disease, such as 
tuberculosis, malignancy, and perforated bowel, under this listing. 
We evaluate these other causes of peritonitis under the appropriate 
body system listings.
    8. Hepatorenal syndrome (5.05D) is defined as functional renal 
failure associated with chronic liver disease in the absence of 
underlying kidney pathology. Hepatorenal syndrome is documented by 
elevation of serum creatinine, marked sodium retention, and oliguria 
(reduced urine output). The requirements of 5.05D are satisfied with 
documentation of any one of the three laboratory findings on one 
evaluation. We do not evaluate known causes of renal dysfunction, 
such as glomerulonephritis, tubular necrosis, drug-induced renal 
disease, and renal infections, under this listing. We evaluate these 
other renal impairments under 6.00ff.
    9. Hepatopulmonary syndrome (5.05E) is defined as arterial 
deoxygenation (hypoxemia) that is associated with chronic liver 
disease due to intrapulmonary arteriovenous shunting and 
vasodilatation in the absence of other causes of arterial 
deoxygenation. Clinical manifestations usually include dyspnea, 
orthodeoxia (increasing hypoxemia with erect position), platypnea 
(improvement of dyspnea with flat position), cyanosis, and clubbing. 
The requirements of 5.05E are satisfied with documentation of any 
one of the findings on one evaluation. In 5.05E1, we require 
documentation of the altitude of the testing facility because 
altitude affects the measurement of arterial oxygenation. We will 
not purchase the specialized studies described in 5.05E2; however, 
if you have had these studies at a time relevant to your claim, we 
will make every reasonable effort to obtain the reports for the 
purpose of establishing whether your impairment meets 5.05E2.
    10. Hepatic encephalopathy (5.05F).
    a. General. Hepatic encephalopathy usually indicates severe loss 
of hepatocellular function. We define hepatic encephalopathy under 
5.05F as a recurrent or chronic neuropsychiatric disorder, 
characterized by abnormal behavior, cognitive dysfunction, altered 
state of consciousness, and ultimately coma and death. The diagnosis 
is established by changes in mental status associated with fleeting 
neurological signs, including ``flapping tremor'' (asterixis), 
characteristic electroencephalographic (EEG) abnormalities, or 
abnormal laboratory values that indicate loss of synthetic liver 
function. We will not purchase the EEG testing described in 5.05F3b; 
however, if you have had this test at a time relevant to your claim, 
we will make every reasonable effort to obtain the report for the 
purpose of establishing whether your impairment meets 5.05F.
    b. Acute encephalopathy. We will not evaluate your acute 
encephalopathy under 5.05F if it results from conditions other than 
chronic liver disease, such as vascular events and neoplastic 
diseases. We will evaluate these other causes of acute 
encephalopathy under the appropriate body system listings.
    11. End stage liver disease (ESLD) documented by scores from the 
SSA Chronic Liver Disease (SSA CLD) calculation (5.05G).
    a. We will use the SSA CLD score to evaluate your ESLD under 
5.05G. We explain how we calculate the SSA CLD score in b. through 
g. of this section.
    b. To calculate the SSA CLD score, we use a formula that 
includes three laboratory values: Serum total bilirubin (mg/dL), 
serum creatinine (mg/dL), and International Normalized Ratio (INR). 
The formula for the SSA CLD score calculation is:

9.57 x [Loge(serum creatinine mg/dL)]
+3.78 x [Loge(serum total bilirubin mg/dL)]
+11.2 x [Loge(INR)]
+6.43

    c. When we indicate ``Loge'' in the formula for the SSA CLD 
score calculation, we mean the ``base e logarithm'' or ``natural 
logarithm'' (ln) of a numerical laboratory value, not the ``base 10 
logarithm'' or ``common logarithm'' (log) of the laboratory value, 
and not the actual laboratory value. For example, if an individual 
has laboratory values of serum creatinine 1.2 mg/dL, serum total 
bilirubin 2.2 mg/dL, and INR 1.0, we would compute the SSA CLD score 
as follows:

9.57 x [Loge(serum creatinine 1.2 mg/dL) = 0.182]
+3.78 x [Loge(serum total bilirubin 2.2 mg/dL) = 0.788]
+11.2 x [Loge(INR 1.0) = 0]
 +6.43
------
= 1.74 + 2.98 + 0 + 6.43
= 11.15, which is then rounded to an SSA CLD score of 11.

    d. For any SSA CLD score calculation, all of the required 
laboratory values must have been obtained within 30 days of each 
other. If there are multiple laboratory values within the 30-day 
interval for any given laboratory test (serum total bilirubin, serum 
creatinine, or INR), we will use the highest value for the SSA CLD 
score calculation. We will round all laboratory values less than 1.0 
up to 1.0.
    e. Listing 5.05G requires two SSA CLD scores. The laboratory 
values for the second SSA CLD score calculation must have been 
obtained at least 60 days after the latest laboratory value for the 
first SSA CLD score and within the required 6-month period. We will 
consider the date of each SSA CLD score to be the date of the first 
laboratory value used for its calculation.
    f. If you are in renal failure or on dialysis within a week of 
any serum creatinine test in the period used for the SSA CLD 
calculation, we will use a serum creatinine of 4, which is the 
maximum serum creatinine level allowed in the calculation, to 
calculate your SSA CLD score.
    g. If you have the two SSA CLD scores required by 5.05G, we will 
find that your impairment meets the criteria of the listing from at 
least the date of the first SSA CLD score.
    12. Liver transplantation (5.09) may be performed for metabolic 
liver disease, progressive liver failure, life-threatening 
complications of liver disease, hepatic malignancy, and acute 
fulminant hepatitis (viral, drug-induced, or toxin-induced). We will 
consider you to be disabled for 1 year from the date of the 
transplantation. Thereafter, we will evaluate your residual 
impairment(s) by considering the adequacy of post-transplant liver 
function, the requirement for post-transplant antiviral therapy, the 
frequency and severity of rejection episodes, comorbid 
complications, and all adverse treatment effects.
    E. How do we evaluate inflammatory bowel disease (IBD)?
    1. Inflammatory bowel disease (5.06) includes, but is not 
limited to, Crohn's disease and ulcerative colitis. These disorders, 
while distinct entities, share many clinical, laboratory, and 
imaging findings, as well as similar treatment regimens. Remissions 
and exacerbations of variable duration are the hallmark of IBD. 
Crohn's disease may involve the entire alimentary tract from the 
mouth to the anus in a segmental, asymmetric fashion. Obstruction, 
stenosis, fistulization, perineal involvement, and extraintestinal 
manifestations are common. Crohn's disease is rarely curable and 
recurrence may be a lifelong problem, even after surgical resection. 
In contrast, ulcerative colitis only affects the colon. The 
inflammatory process may be limited to the rectum, extend proximally 
to include any contiguous segment, or involve the entire colon. 
Ulcerative colitis may be cured by total colectomy.
    2. Symptoms and signs of IBD include diarrhea, fecal 
incontinence, rectal bleeding, abdominal pain, fatigue, fever, 
nausea, vomiting, arthralgia, abdominal tenderness, palpable 
abdominal mass (usually inflamed loops of bowel) and perineal 
disease. You may also have signs or laboratory findings indicating 
malnutrition, such as weight loss, edema, anemia, hypoalbuminemia, 
hypokalemia, hypocalcemia, or hypomagnesemia.
    3. IBD may be associated with significant extraintestinal 
manifestations in a variety of body systems. These include, but are 
not limited to, involvement of the eye (for example, uveitis, 
episcleritis, iritis); hepatobiliary disease (for example, 
gallstones, primary sclerosing cholangitis); urologic disease (for 
example, kidney stones, obstructive hydronephrosis); skin 
involvement (for example, erythema nodosum, pyoderma gangrenosum); 
or non-destructive inflammatory arthritis. You may also have 
associated thromboembolic disorders or vascular disease. These 
manifestations may not correlate with the severity of your IBD. If 
your impairment does not meet any of the criteria of 5.06, we will 
consider the effects of your extraintestinal manifestations in 
determining whether you have an impairment(s) that meets or 
medically equals another listing, and we will also consider the 
effects of your extraintestinal manifestations when we assess your 
residual functional capacity.
    4. Surgical diversion of the intestinal tract, including 
ileostomy and colostomy, does not preclude any gainful activity if 
you are able to maintain adequate nutrition and function of the 
stoma. However, if you are not able to maintain adequate nutrition, 
we will evaluate your impairment under 5.08.
    F. How do we evaluate short bowel syndrome (SBS)?

[[Page 59425]]

    1. Short bowel syndrome (5.07) is a disorder that occurs when 
ischemic vascular insults (for example, volvulus), trauma, or IBD 
complications require surgical resection of more than one-half of 
the small intestine, resulting in the loss of intestinal absorptive 
surface and a state of chronic malnutrition. The management of SBS 
requires long-term parenteral nutrition via an indwelling central 
venous catheter (central line); the process is often referred to as 
hyperalimentation or total parenteral nutrition (TPN). Individuals 
with SBS can also feed orally, with variable amounts of nutrients 
being absorbed through their remaining intestine. Over time, some of 
these individuals can develop additional intestinal absorptive 
surface, and may ultimately be able to be weaned off their 
parenteral nutrition.
    2. Your impairment will continue to meet 5.07 as long as you 
remain dependent on daily parenteral nutrition via a central venous 
catheter for most of your nutritional requirements. Long-term 
complications of SBS and parenteral nutrition include central line 
infections (with or without septicemia), thrombosis, hepatotoxicity, 
gallstones, and loss of venous access sites. Intestinal 
transplantation is the only definitive treatment for individuals 
with SBS who remain chronically dependent on parenteral nutrition.
    3. To document SBS, we need a copy of the operative report of 
intestinal resection, the summary of the hospitalization(s) 
including: Details of the surgical findings, medically appropriate 
postoperative imaging studies that reflect the amount of your 
residual small intestine, or if we cannot get one of these reports, 
other medical reports that include details of the surgical findings. 
We also need medical documentation that you are dependent on daily 
parenteral nutrition to provide most of your nutritional 
requirements.
    G. How do we evaluate weight loss due to any digestive disorder?
    1. In addition to the impairments specifically mentioned in 
these listings, other digestive disorders, such as esophageal 
stricture, pancreatic insufficiency, and malabsorption, may result 
in significant weight loss. We evaluate weight loss due to any 
digestive disorder under 5.08 by using the Body Mass Index (BMI). We 
also provide a criterion in 5.06B for lesser weight loss resulting 
from IBD.
    2. BMI is the ratio of your weight to the square of your height. 
Calculation and interpretation of the BMI are independent of gender 
in adults.
    a. We calculate BMI using inches and pounds, meters and 
kilograms, or centimeters and kilograms. We must have measurements 
of your weight and height without shoes for these calculations.
    b. We calculate BMI using one of the following formulas:
    [GRAPHIC] [TIFF OMITTED] TR19OC07.003
    
    [GRAPHIC] [TIFF OMITTED] TR19OC07.004
    
    [GRAPHIC] [TIFF OMITTED] TR19OC07.005
    
    H. What do we mean by the phrase ``consider under a disability 
for 1 year''? We use the phrase ``consider under a disability for 1 
year'' following a specific event in 5.02, 5.05A, and 5.09 to 
explain how long your impairment can meet the requirements of those 
particular listings. This phrase does not refer to the date on which 
your disability began, only to the date on which we must reevaluate 
whether your impairment continues to meet a listing or is otherwise 
disabling. For example, if you have received a liver transplant, you 
may have become disabled before the transplant because of chronic 
liver disease. Therefore, we do not restrict our determination of 
the onset of disability to the date of the specified event. We will 
establish an onset date earlier than the date of the specified event 
if the evidence in your case record supports such a finding.
    I. How do we evaluate impairments that do not meet one of the 
digestive disorder listings?
    1. These listings are only examples of common digestive 
disorders 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, if you have hepatitis B or C and 
you are depressed, we will evaluate your impairment under 12.04.
    2. If you have a severe medically determinable impairment(s) 
that does not meet a listing, we will determine whether your 
impairment(s) medically equals a listing. (See Sec. Sec.  404.1526 
and 416.926.) If your impairment(s) does not meet or medically equal 
a listing, you may or may not have the residual functional capacity 
to engage in substantial gainful activity. In this situation, we 
will proceed to the fourth, and if necessary, the fifth steps of the 
sequential evaluation process in Sec. Sec.  404.1520 and 416.920. 
When we decide whether you continue to be disabled, we use the rules 
in Sec. Sec.  404.1594, 416.994, and 416.994a as appropriate.
    5.01 Category of Impairments, Digestive System
    5.02 Gastrointestinal hemorrhaging from any cause, requiring 
blood transfusion (with or without hospitalization) of at least 2 
units of blood per transfusion, and occurring at least three times 
during a consecutive 6-month period. The transfusions must be at 
least 30 days apart within the 6-month period. Consider under a 
disability for 1 year following the last documented transfusion; 
thereafter, evaluate the residual impairment(s).
    5.03 [Reserved]
    5.04 [Reserved]
    5.05 Chronic liver disease, with:
    A. Hemorrhaging from esophageal, gastric, or ectopic varices or 
from portal hypertensive gastropathy, demonstrated by endoscopy, x-
ray, or other appropriate medically acceptable imaging, resulting in 
hemodynamic instability as defined in 5.00D5, and requiring 
hospitalization for transfusion of at least 2 units of blood. 
Consider under a disability for 1 year

[[Page 59426]]

following the last documented transfusion; thereafter, evaluate the 
residual impairment(s).

OR

    B. Ascites or hydrothorax not attributable to other causes, 
despite continuing treatment as prescribed, present on at least two 
evaluations at least 60 days apart within a consecutive 6-month 
period. Each evaluation must be documented by:
    1. Paracentesis or thoracentesis; or
    2. Appropriate medically acceptable imaging or physical 
examination and one of the following:
    a. Serum albumin of 3.0 g/dL or less; or
    b. International Normalized Ratio (INR) of at least 1.5.

OR

    C. Spontaneous bacterial peritonitis with peritoneal fluid 
containing an absolute neutrophil count of at least 250 cells/
mm3.

OR

    D. Hepatorenal syndrome as described in 5.00D8, with one of the 
following:
    1. Serum creatinine elevation of at least 2 mg/dL; or
    2. Oliguria with 24-hour urine output less than 500 mL; or
    3. Sodium retention with urine sodium less than 10 mEq per 
liter.

OR

    E. Hepatopulmonary syndrome as described in 5.00D9, with:
    1. Arterial oxygenation (PaO2) on room air 
of:
    a. 60 mm Hg or less, at test sites less than 3000 feet above sea 
level, or
    b. 55 mm Hg or less, at test sites from 3000 to 6000 feet, or
    c. 50 mm Hg or less, at test sites above 6000 feet; or
    2. Documentation of intrapulmonary arteriovenous shunting by 
contrast-enhanced echocardiography or macroaggregated albumin lung 
perfusion scan.

OR

    F. Hepatic encephalopathy as described in 5.00D10, with 1 and 
either 2 or 3:
    1. Documentation of abnormal behavior, cognitive dysfunction, 
changes in mental status, or altered state of consciousness (for 
example, confusion, delirium, stupor, or coma), present on at least 
two evaluations at least 60 days apart within a consecutive 6-month 
period; and
    2. History of transjugular intrahepatic portosystemic shunt 
(TIPS) or any surgical portosystemic shunt: or
    3. One of the following occurring on at least two evaluations at 
least 60 days apart within the same consecutive 6-month period as in 
F1:
    a. Asterixis or other fluctuating physical neurological 
abnormalities; or
    b. Electroencephalogram (EEG) demonstrating triphasic slow wave 
activity; or
    c. Serum albumin of 3.0 g/dL or less; or
    d. International Normalized Ratio (INR) of 1.5 or greater.

OR

    G. End stage liver disease with SSA CLD scores of 22 or greater 
calculated as described in 5.00D11. Consider under a disability from 
at least the date of the first score.
    5.06 Inflammatory bowel disease (IBD) documented by endoscopy, 
biopsy, appropriate medically acceptable imaging, or operative 
findings with:
    A. Obstruction of stenotic areas (not adhesions) in the small 
intestine or colon with proximal dilatation, confirmed by 
appropriate medically acceptable imaging or in surgery, requiring 
hospitalization for intestinal decompression or for surgery, and 
occurring on at least two occasions at least 60 days apart within a 
consecutive 6-month period;

OR

    B. Two of the following despite continuing treatment as 
prescribed and occurring within the same consecutive 6-month period:
    1. Anemia with hemoglobin of less than 10.0 g/dL, present on at 
least two evaluations at least 60 days apart; or
    2. Serum albumin of 3.0 g/dL or less, present on at least two 
evaluations at least 60 days apart; or
    3. Clinically documented tender abdominal mass palpable on 
physical examination with abdominal pain or cramping that is not 
completely controlled by prescribed narcotic medication, present on 
at least two evaluations at least 60 days apart; or
    4. Perineal disease with a draining abscess or fistula, with 
pain that is not completely controlled by prescribed narcotic 
medication, present on at least two evaluations at least 60 days 
apart; or
    5. Involuntary weight loss of at least 10 percent from baseline, 
as computed in pounds, kilograms, or BMI, present on at least two 
evaluations at least 60 days apart; or
    6. Need for supplemental daily enteral nutrition via a 
gastrostomy or daily parenteral nutrition via a central venous 
catheter.
    5.07 Short bowel syndrome (SBS), due to surgical resection of 
more than one-half of the small intestine, with dependence on daily 
parenteral nutrition via a central venous catheter (see 5.00F).
    5.08 Weight loss due to any digestive disorder despite 
continuing treatment as prescribed, with BMI of less than 17.50 
calculated on at least two evaluations at least 60 days apart within 
a consecutive 6-month period.
    5.09 Liver transplantation. Consider under a disability for 1 
year following the date of transplantation; thereafter, evaluate the 
residual impairment(s) (see 5.00D12 and 5.00H).
* * * * *

0
4. Revise listing 6.02C4 in part A of appendix 1 to subpart P of part 
404 to read as follows:

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

* * * * *

Part A

* * * * *
    6.02 * * *
* * * * *
    C. * * *
    4. Persistent anorexia with weight loss determined by body mass 
index (BMI) of less than 18.0, calculated on at least two 
evaluations at least 30 days apart within a consecutive 6-month 
period (see 5.00G2).
* * * * *

0
5. Revise listing 12.09G in part A of appendix 1 to subpart P of part 
404 to read as follows:

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

* * * * *

Part A

* * * * *
    12.09 * * *
* * * * *
    G. Gastritis. Evaluate under 5.00.
* * * * *

0
6. Revise section 105.00 in part B of appendix 1 to subpart P of part 
404 to read as follows:

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

* * * * *

Part B

* * * * *

105.00 DIGESTIVE SYSTEM

    A. What kinds of disorders do we consider in the digestive 
system? Disorders of the digestive system include gastrointestinal 
hemorrhage, hepatic (liver) dysfunction, inflammatory bowel disease, 
short bowel syndrome, and malnutrition. They may also lead to 
complications, such as obstruction, or be accompanied by 
manifestations in other body systems. Congenital abnormalities 
involving the organs of the gastrointestinal system may interfere 
with the ability to maintain adequate nutrition, growth, and 
development.
    B. What documentation do we need? We need a record of your 
medical evidence, including clinical and laboratory findings. The 
documentation should include appropriate medically acceptable 
imaging studies and reports of endoscopy, operations, and pathology, 
as appropriate to each listing, to document the severity and 
duration of your digestive disorder. We may also need assessments of 
your growth and development. Medically acceptable imaging includes, 
but is not limited to, x-ray imaging, sonography, computerized axial 
tomography (CAT scan), magnetic resonance imaging (MRI), and 
radionuclide scans. Appropriate means that the technique used is the 
proper one to support the evaluation and diagnosis of the disorder. 
The findings required by these listings must occur within the period 
we are considering in connection with your application or continuing 
disability review.
    C. How do we consider the effects of treatment?
    1. Digestive disorders frequently respond to medical or surgical 
treatment; therefore, we generally consider the severity and 
duration of these disorders within the context of the prescribed 
treatment.
    2. We assess the effects of treatment, including medication, 
therapy, surgery, or

[[Page 59427]]

any other form of treatment you receive, by determining if there are 
improvements in the symptoms, signs, and laboratory findings of your 
digestive disorder. We also assess any side effects of your 
treatment that may further limit your functioning.
    3. To assess the effects of your treatment, we may need 
information about:
    a. The treatment you have been prescribed (for example, the type 
of medication or therapy, or your use of parenteral (intravenous) 
nutrition or supplemental enteral nutrition via a gastrostomy);
    b. The dosage, method, and frequency of administration;
    c. Your response to the treatment;
    d. Any adverse effects of such treatment; and
    e. The expected duration of the treatment.
    4. Because the effects of treatment may be temporary or long-
term, in most cases we need information about the impact of your 
treatment, including its expected duration and side effects, over a 
sufficient period of time to help us assess its outcome. When 
adverse effects of treatment contribute to the severity of your 
impairment(s), we will consider the duration or expected duration of 
the treatment when we assess the duration of your impairment(s).
    5. If you need parenteral (intravenous) nutrition or 
supplemental enteral nutrition via a gastrostomy to avoid 
debilitating complications of a digestive disorder, this treatment 
will not, in itself, indicate that you have marked and severe 
functional limitations. The exceptions are 105.07, short bowel 
syndrome, and 105.10, for children who have not attained age 3 and 
who require supplemental daily enteral feedings via a gastrostomy 
(see 105.00F and 105.00H).
    6. If you have not received ongoing treatment or have not had an 
ongoing relationship with the medical community despite the 
existence of a severe impairment(s), we will evaluate the severity 
and duration of your digestive impairment on the basis of current 
medical and other evidence in your case record. If you have not 
received treatment, you may not be able to show an impairment that 
meets the criteria of one of the digestive system listings, but your 
digestive impairment may medically equal a listing or functionally 
equal the listings.
    D. How do we evaluate chronic liver disease?
    1. General. Chronic liver disease is characterized by liver cell 
necrosis, inflammation, or scarring (fibrosis or cirrhosis), due to 
any cause, that persists for more than 6 months. Chronic liver 
disease may result in portal hypertension, cholestasis (suppression 
of bile flow), extrahepatic manifestations, or liver cancer. (We 
evaluate liver cancer under 113.03.) Significant loss of liver 
function may be manifested by hemorrhage from varices or portal 
hypertensive gastropathy, ascites (accumulation of fluid in the 
abdominal cavity), hydrothorax (ascitic fluid in the chest cavity), 
or encephalopathy. There can also be progressive deterioration of 
laboratory findings that are indicative of liver dysfunction. Liver 
transplantation is the only definitive cure for end stage liver 
disease (ESLD).
    2. Examples of chronic liver disease include, but are not 
limited to, biliary atresia, chronic hepatitis, non-alcoholic 
steatohepatitis (NASH), primary biliary cirrhosis (PBC), primary 
sclerosing cholangitis (PSC), autoimmune hepatitis, hemochromatosis, 
drug-induced liver disease, Wilson's disease, and serum alpha-1 
antitrypsin deficiency. Children can also have congenital 
abnormalities of abdominal organs or inborn metabolic disorders that 
result in chronic liver disease. Acute hepatic injury is frequently 
reversible as in viral, drug-induced, toxin-induced, and ischemic 
hepatitis. In the absence of evidence of a chronic impairment, 
episodes of acute liver disease do not meet 105.05.
    3. Manifestations of chronic liver disease.
    a. Symptoms may include, but are not limited to, pruritis 
(itching), fatigue, nausea, loss of appetite, or sleep disturbances. 
Children can also have associated developmental delays or poor 
school performance. Symptoms of chronic liver disease may have a 
poor correlation with the severity of liver disease and functional 
ability.
    b. Signs may include, but are not limited to, jaundice, 
enlargement of the liver and spleen, ascites, peripheral edema, and 
altered mental status.
    c. Laboratory findings may include, but are not limited to, 
increased liver enzymes, increased serum total bilirubin, increased 
ammonia levels, decreased serum albumin, and abnormal coagulation 
studies, such as increased International Normalized Ratio (INR) or 
decreased platelet counts. Abnormally low serum albumin or elevated 
INR levels indicate loss of synthetic liver function, with increased 
likelihood of cirrhosis and associated complications. However, other 
abnormal lab tests, such as liver enzymes, serum total bilirubin, or 
ammonia levels, may have a poor correlation with the severity of 
liver disease and functional ability. A liver biopsy may demonstrate 
the degree of liver cell necrosis, inflammation, fibrosis, and 
cirrhosis. If you have had a liver biopsy, we will make every 
reasonable effort to obtain the results; however, we will not 
purchase a liver biopsy. Imaging studies (CAT scan, ultrasound, MRI) 
may show the size and consistency (fatty liver, scarring) of the 
liver and document ascites (see 105.00D6).
    4. Chronic viral hepatitis infections.
    a. General.
    (i) Chronic viral hepatitis infections are commonly caused by 
hepatitis C virus (HCV), and to a lesser extent, hepatitis B virus 
(HBV). Usually, these are slowly progressive disorders that persist 
over many years during which the symptoms and signs are typically 
nonspecific, intermittent, and mild (for example, fatigue, 
difficulty with concentration, or right upper quadrant pain). 
Laboratory findings (liver enzymes, imaging studies, liver biopsy 
pathology) and complications are generally similar in HCV and HBV. 
The spectrum of these chronic viral hepatitis infections ranges 
widely and includes an asymptomatic state; insidious disease with 
mild to moderate symptoms associated with fluctuating liver tests; 
extrahepatic manifestations; cirrhosis, both compensated and 
decompensated; ESLD with the need for liver transplantation; and 
liver cancer. Treatment for chronic viral hepatitis infections 
varies considerably based on age, medication tolerance, treatment 
response, adverse effects of treatment, and duration of the 
treatment. Comorbid disorders, such as HIV infection, may affect the 
clinical course of viral hepatitis infection(s) or may alter the 
response to medical treatment.
    (ii) We evaluate all types of chronic viral hepatitis infections 
under 105.05 or any listing in an affected body system(s). If your 
impairment(s) does not meet or medically equal a listing, we will 
consider the effects of your hepatitis when we assess whether your 
impairment(s) functionally equals the listings.
    b. Chronic hepatitis B virus (HBV) infection.
    (i) Chronic HBV infection is diagnosed by the detection of 
hepatitis B surface antigen (HBsAg) in the blood for at least 6 
months. In addition, detection of the hepatitis B envelope antigen 
(HBeAg) suggests an increased likelihood of progression to cirrhosis 
and ESLD.
    (ii) The therapeutic goal of treatment is to suppress HBV 
replication and thereby prevent progression to cirrhosis and ESLD. 
Treatment usually includes a combination of interferon injections 
and oral antiviral agents. Common adverse effects of treatment are 
the same as noted in 105.00D4c(ii) for HCV, and generally end within 
a few days after treatment is discontinued.
    c. Chronic hepatitis C virus (HCV) infection.
    (i) Chronic HCV infection is diagnosed by the detection of 
hepatitis C viral RNA in the blood for at least 6 months. 
Documentation of the therapeutic response to treatment is also 
monitored by the quantitative assay of serum HCV RNA (``HCV viral 
load''). Treatment usually includes a combination of interferon 
injections and oral ribavirin; whether a therapeutic response has 
occurred is usually assessed after 12 weeks of treatment by checking 
the HCV viral load. If there has been a substantial reduction in HCV 
viral load (also known as early viral response, or EVR), this 
reduction is predictive of a sustained viral response with 
completion of treatment. Combined therapy is commonly discontinued 
after 12 weeks when there is no early viral response, since in that 
circumstance there is little chance of obtaining a sustained viral 
response (SVR). Otherwise, treatment is usually continued for a 
total of 48 weeks.
    (ii) Combined interferon and ribavirin treatment may have 
significant adverse effects that may require dosing reduction, 
planned interruption of treatment, or discontinuation of treatment. 
Adverse effects may include: Anemia (ribavirin-induced hemolysis), 
neutropenia, thrombocytopenia, fever, cough, fatigue, myalgia, 
arthralgia, nausea, loss of appetite, pruritis, and insomnia. 
Behavioral side effects may also occur. Influenza-like symptoms are 
generally worse in the first 4 to 6 hours after each interferon 
injection and during the first weeks of treatment. Adverse effects 
generally end within a few days after treatment is discontinued.

[[Page 59428]]

    d. Extrahepatic manifestations of HBV and HCV. In addition to 
their hepatic manifestations, both HBV and HCV may have significant 
extrahepatic manifestations in a variety of body systems. These 
include, but are not limited to: Keratoconjunctivitis (sicca 
syndrome), glomerulonephritis, skin disorders (for example, lichen 
planus, porphyria cutanea tarda), neuropathy, and immune dysfunction 
(for example, cryoglobulinemia, Sj[ouml]gren's syndrome, and 
vasculitis). The extrahepatic manifestations of HBV and HCV may not 
correlate with the severity of your hepatic impairment. If your 
impairment(s) does not meet or medically equal a listing in an 
affected body system(s), we will consider the effects of your 
extrahepatic manifestations when we determine whether your 
impairment(s) functionally equals the listings.
    5. Gastrointestinal hemorrhage (105.02 and 105.05A). 
Gastrointestinal hemorrhaging can result in hematemesis (vomiting of 
blood), melena (tarry stools), or hematochezia (bloody stools). 
Under 105.02, the required transfusions of at least 10 cc of blood/
kg of body weight must be at least 30 days apart and occur at least 
three times during a consecutive 6-month period. Under 105.05A, 
hemodynamic instability is diagnosed with signs such as pallor (pale 
skin), diaphoresis (profuse perspiration), rapid pulse, low blood 
pressure, postural hypotension (pronounced fall in blood pressure 
when arising to an upright position from lying down) or syncope 
(fainting). Hemorrhaging that results in hemodynamic instability is 
potentially life-threatening and therefore requires hospitalization 
for transfusion and supportive care. Under 105.05A, we require only 
one hospitalization for transfusion of at least 10 cc of blood/kg of 
body weight.
    6. Ascites or hydrothorax (105.05B) indicates significant loss 
of liver function due to chronic liver disease. We evaluate ascites 
or hydrothorax that is not attributable to other causes under 
105.05B. The required findings must be present on at least two 
evaluations at least 60 days apart within a consecutive 6-month 
period and despite continuing treatment as prescribed.
    7. Spontaneous bacterial peritonitis (105.05C) is an infectious 
complication of chronic liver disease. It is diagnosed by ascitic 
peritoneal fluid that is documented to contain an absolute 
neutrophil count of at least 250 cells/mm \3\. The required finding 
in 105.05C is satisfied with one evaluation documenting peritoneal 
fluid infection. We do not evaluate other causes of peritonitis that 
are unrelated to chronic liver disease, such as tuberculosis, 
malignancy, and perforated bowel, under this listing. We evaluate 
these other causes of peritonitis under the appropriate body system 
listings.
    8. Hepatorenal syndrome (105.05D) is defined as functional renal 
failure associated with chronic liver disease in the absence of 
underlying kidney pathology. Hepatorenal syndrome is documented by 
elevation of serum creatinine, marked sodium retention, and oliguria 
(reduced urine output). The requirements of 105.05D are satisfied 
with documentation of any one of the three laboratory findings on 
one evaluation. We do not evaluate known causes of renal 
dysfunction, such as glomerulonephritis, tubular necrosis, drug-
induced renal disease, and renal infections, under this listing. We 
evaluate these other renal impairments under 106.00ff.
    9. Hepatopulmonary syndrome (105.05E) is defined as arterial 
deoxygenation (hypoxemia) that is associated with chronic liver 
disease due to intrapulmonary arteriovenous shunting and 
vasodilatation, in the absence of other causes of arterial 
deoxygenation. Clinical manifestations usually include dyspnea, 
orthodeoxia (increasing hypoxemia with erect position), platypnea 
(improvement of dyspnea with flat position), cyanosis, and clubbing. 
The requirements of 105.05E are satisfied with documentation of any 
one of the findings on one evaluation. In 105.05E1, we require 
documentation of the altitude of the testing facility because 
altitude affects the measurement of arterial oxygenation. We will 
not purchase the specialized studies described in 105.05E2; however, 
if you have had these studies at a time relevant to your claim, we 
will make every reasonable effort to obtain the reports for the 
purpose of establishing whether your impairment meets 105.05E2.
    10. Hepatic encephalopathy (105.05F).
    a. General. Hepatic encephalopathy usually indicates severe loss 
of hepatocellular function. We define hepatic encephalopathy under 
105.05F as a recurrent or chronic neuropsychiatric disorder, 
characterized by abnormal behavior, cognitive dysfunction, altered 
state of consciousness, and ultimately coma and death. The diagnosis 
is established by changes in mental status associated with fleeting 
neurological signs, including ``flapping tremor'' (asterixis), 
characteristic electroencephalographic (EEG) abnormalities, or 
abnormal laboratory values that indicate loss of synthetic liver 
function. We will not purchase the EEG testing described in 
105.05F3b. However, if you have had this test at a time relevant to 
your claim, we will make every reasonable effort to obtain the 
report for the purpose of establishing whether your impairment meets 
105.05F.
    b. Acute encephalopathy. We will not evaluate your acute 
encephalopathy under 105.05F if it results from conditions other 
than chronic liver disease, such as vascular events and neoplastic 
diseases. We will evaluate these other causes of acute 
encephalopathy under the appropriate body system listings.
    11. End stage liver disease (ESLD) documented by scores from the 
SSA Chronic Liver Disease (SSA CLD) calculation (105.05G1) and SSA 
Chronic Liver Disease-Pediatric (SSA CLD-P) calculation (105.05G2).
    a. SSA CLD score.
    (i) If you are age 12 or older, we will use the SSA CLD score to 
evaluate your ESLD under 105.05G1. We explain how we calculate the 
SSA CLD score in a(ii) through a(vii) of this section.
    (ii) To calculate the SSA CLD score, we use a formula that 
includes three laboratory values: Serum total bilirubin (mg/dL), 
serum creatinine (mg/dL), and International Normalized Ratio (INR). 
The formula for the SSA CLD score calculation is:

9.57 x [Loge (serum creatinine mg/dL)]
+3.78 x [Loge (serum total bilirubin mg/dL)]
+11.2 x [Loge (INR)]
+6.43

    (iii) When we indicate ``Loge'' in the formula for the SSA CLD 
score calculation, we mean the ``base e logarithm'' or ``natural 
logarithm'' (ln) of a numerical laboratory value, not the ``base 10 
logarithm'' or ``common logarithm'' (log) of the laboratory value, 
and not the actual laboratory value. For an example of SSA CLD 
calculation, see 5.00D11c.
    (iv) For any SSA CLD score calculation, all of the required 
laboratory values must have been obtained within 30 days of each 
other. If there are multiple laboratory values within the 30-day 
interval for any given laboratory test (serum total bilirubin, serum 
creatinine, or INR), we will use the highest value for the SSA CLD 
score calculation. We will round all laboratory values less than 1.0 
up to 1.0.
    (v) Listing 105.05G requires two SSA CLD scores. The laboratory 
values for the second SSA CLD score calculation must have been 
obtained at least 60 days after the latest laboratory value for the 
first SSA CLD score and within the required 6-month period. We will 
consider the date of each SSA CLD score to be the date of the first 
laboratory value used for its calculation.
    (vi) If you are in renal failure or on dialysis within a week of 
any serum creatinine test in the period used for the SSA CLD 
calculation, we will use a serum creatinine of 4, which is the 
maximum serum creatinine level allowed in the calculation, to 
calculate your SSA CLD score.
    (vii) If you have the two SSA CLD scores required by 105.05G1, 
we will find that your impairment meets the criteria of the listing 
from at least the date of the first SSA CLD score.
    b. SSA CLD-P score.
    (i) If you have not attained age 12, we will use the SSA CLD-P 
score to evaluate your ESLD under 105.05G2. We explain how we 
calculate the SSA CLD-P score in b(ii) through b(vii) of this 
section.
    (ii) To calculate the SSA CLD-P score, we use a formula that 
includes four parameters: Serum total bilirubin (mg/dL), 
International Normalized Ratio (INR), serum albumin (g/dL), and 
whether growth failure is occurring. The formula for the SSA CLD-P 
score calculation is:

4.80 x [Loge (serum total bilirubin mg/dL)]
+18.57 x [Loge (INR)]
-6.87 x [Loge (serum albumin g/dL)]
+6.67 if the child has growth failure (<-2 standard deviations for 
weight or height)

    (iii) When we indicate ``Loge'' in the formula for the SSA CLD-P 
score calculation, we mean the ``base e logarithm'' or ``natural 
logarithm'' (ln) of a numerical laboratory value, not the ``base 10 
logarithm'' or ``common logarithm'' (log) of the laboratory value, 
and not the actual laboratory value. For example, if a female child 
is 4.0 years old, has a current weight of 13.5 kg (10th percentile 
for age) and height of 92 cm (less than the third percentile for 
age), and has laboratory values of serum total bilirubin 2.2 mg/dL, 
INR 1.0, and serum albumin 3.5 g/dL, we will compute the SSA CLD-P 
score as follows:


[[Page 59429]]


4.80 x [Loge +(serum total bilirubin 2.2 mg/dL) = 0.788]
+18.57 x [Loge (INR 1.0) = 0]
-6.87 x [Loge +(serum albumin 3.5 g/dL) = 1.253]
+6.67
------
= 3.78 + 0 -8.61 + 6.67
= 1.84, which is then rounded to an SSA CLD-P score of 2

    (iv) For any SSA CLD-P score calculation, all of the required 
laboratory values (serum total bilirubin, INR, or serum albumin) 
must have been obtained within 30 days of each other. We will not 
purchase INR values for children who have not attained age 12. If 
there is no INR value for a child under 12 within the applicable 
time period, we will use an INR value of 1.1 to calculate the SSA 
CLD-P score. If there are multiple laboratory values within the 30-
day interval for any given laboratory test, we will use the highest 
serum total bilirubin and INR values and the lowest serum albumin 
value for the SSA CLD-P score calculation. We will round all 
laboratory values less than 1.0 up to 1.0.
    (v) The weight and length/height measurements used for the 
calculation must be obtained from one evaluation within the same 30-
day period as in D11b(iv).
    (vi) Listing 105.05G2 requires two SSA CLD-P scores. The 
laboratory values for the second SSA CLD-P score calculation must 
have been obtained at least 60 days after the latest laboratory 
value for the first SSA CLD-P score and within the required 6-month 
period. We will consider the date of each SSA CLD-P score to be the 
date of the first laboratory value used for its calculation.
    (vii) If you have the two SSA CLD-P scores required by listing 
105.05G2, we will find that your impairment meets the criteria of 
the listing from at least the date of the first SSA CLD-P score.
    12. Extrahepatic biliary atresia (EBA) (105.05H) usually 
presents in the first 2 months of life with persistent jaundice. The 
impairment meets 105.05H if the diagnosis of EBA is confirmed by 
liver biopsy or intraoperative cholangiogram that shows obliteration 
of the extrahepatic biliary tree. EBA is usually surgically treated 
by portoenterostomy (for example, Kasai procedure). If this surgery 
is not performed in the first months of life or is not completely 
successful, liver transplantation is indicated. If you have had a 
liver transplant, we will evaluate your impairment under 105.09.
    13. Liver transplantation (105.09) may be performed for 
metabolic liver disease, progressive liver failure, life-threatening 
complications of liver disease, hepatic malignancy, and acute 
fulminant hepatitis (viral, drug-induced, or toxin-induced). We will 
consider you to be disabled for 1 year from the date of the 
transplantation. Thereafter, we will evaluate your residual 
impairment(s) by considering the adequacy of post-transplant liver 
function, the requirement for post-transplant antiviral therapy, the 
frequency and severity of rejection episodes, comorbid 
complications, and all adverse treatment effects.
    E. How do we evaluate inflammatory bowel disease (IBD)?
    1. Inflammatory bowel disease (105.06) includes, but is not 
limited to, Crohn's disease and ulcerative colitis. These disorders, 
while distinct entities, share many clinical, laboratory, and 
imaging findings, as well as similar treatment regimens. Remissions 
and exacerbations of variable duration are the hallmark of IBD. 
Crohn's disease may involve the entire alimentary tract from the 
mouth to the anus in a segmental, asymmetric fashion. Obstruction, 
stenosis, fistulization, perineal involvement, and extraintestinal 
manifestations are common. Crohn's disease is rarely curable and 
recurrence may be a lifelong problem, even after surgical resection. 
In contrast, ulcerative colitis only affects the colon. The 
inflammatory process may be limited to the rectum, extend proximally 
to include any contiguous segment, or involve the entire colon. 
Ulcerative colitis may be cured by total colectomy.
    2. Symptoms and signs of IBD include diarrhea, fecal 
incontinence, rectal bleeding, abdominal pain, fatigue, fever, 
nausea, vomiting, arthralgia, abdominal tenderness, palpable 
abdominal mass (usually inflamed loops of bowel) and perineal 
disease. You may also have signs or laboratory findings indicating 
malnutrition, such as weight loss, edema, anemia, hypoalbuminemia, 
hypokalemia, hypocalcemia, or hypomagnesemia.
    3. IBD may be associated with significant extraintestinal 
manifestations in a variety of body systems. These include, but are 
not limited to, involvement of the eye (for example, uveitis, 
episcleritis, iritis); hepatobiliary disease (for example, 
gallstones, primary sclerosing cholangitis); urologic disease (for 
example, kidney stones, obstructive hydronephrosis); skin 
involvement (for example, erythema nodosum, pyoderma gangrenosum); 
or non-destructive inflammatory arthritis. You may also have 
associated thromboembolic disorders or vascular disease. These 
manifestations may not correlate with the severity of your IBD. If 
your impairment does not meet any of the criteria of 105.06, we will 
consider the effects of your extraintestinal manifestations in 
determining whether you have an impairment(s) that meets or 
medically equals another listing, and we will also consider the 
effects of your extraintestinal manifestations when we determine 
whether your impairment(s) functionally equals the listings.
    4. Surgical diversion of the intestinal tract, including 
ileostomy and colostomy, does not very seriously interfere with age-
appropriate functioning if you are able to maintain adequate 
nutrition and function of the stoma. However, if you are not able to 
maintain adequate nutrition, we will evaluate your impairment under 
105.08.
    F. How do we evaluate short bowel syndrome (SBS)?
    1. Short bowel syndrome (105.07) is a disorder that occurs when 
congenital intestinal abnormalities, ischemic vascular insults (for 
example, necrotizing enterocolitis, volvulus), trauma, or IBD 
complications require surgical resection of more than one-half of 
the small intestine, resulting in the loss of intestinal absorptive 
surface and a state of chronic malnutrition. The management of SBS 
requires long-term parenteral nutrition via an indwelling central 
venous catheter (central line); the process is often referred to as 
hyperalimentation or total parenteral nutrition (TPN). Children with 
SBS can also feed orally, with variable amounts of nutrients being 
absorbed through their remaining intestine. Over time, some of these 
children can develop additional intestinal absorptive surface, and 
may ultimately be able to be weaned off their parenteral nutrition.
    2. Your impairment will continue to meet 105.07 as long as you 
remain dependent on daily parenteral nutrition via a central venous 
catheter for most of your nutritional requirements. Long-term 
complications of SBS and parenteral nutrition include abnormal 
growth rates, central line infections (with or without septicemia), 
thrombosis, hepatotoxicity, gallstones, and loss of venous access 
sites. Intestinal transplantation is the only definitive treatment 
for children with SBS who remain chronically dependent on parenteral 
nutrition.
    3. To document SBS, we need a copy of the operative report of 
intestinal resection, the summary of the hospitalization(s) 
including: Details of the surgical findings, medically appropriate 
postoperative imaging studies that reflect the amount of your 
residual small intestine, or if we cannot get one of these reports, 
other medical reports that include details of the surgical findings. 
We also need medical documentation that you are dependent on daily 
parenteral nutrition to provide most of your nutritional 
requirements.
    G. How do we evaluate malnutrition in children?
    1. Many types of digestive disorders can result in malnutrition 
and growth retardation. To meet the malnutrition criteria in 
105.08A, we need documentation of a digestive disorder with 
associated chronic nutritional deficiency despite prescribed 
treatment.
    2. We evaluate the growth retardation criteria in 105.08B by 
using the most recent growth charts by the Centers for Disease 
Control and Prevention (CDC).
    a. If you have not attained age 2, we use weight-for-length 
measurements to assess whether your impairment meets the requirement 
of 105.08B1. CDC weight-for-length charts are age- and gender-
specific.
    b. If you are a child age 2 or older, we use BMI-for-age 
measurements to assess whether your impairment meets the requirement 
of 105.08B2. BMI is the ratio of your weight to the square of your 
height. BMI-for-age is plotted on the CDC's gender-specific growth 
charts.
    c. We calculate BMI using inches and pounds, meters and 
kilograms, or centimeters and kilograms. We must have measurements 
of your weight and height without shoes for these calculations.
    d. We calculate BMI using one of the following formulas:

[[Page 59430]]

[GRAPHIC] [TIFF OMITTED] TR19OC07.003

[GRAPHIC] [TIFF OMITTED] TR19OC07.004

[GRAPHIC] [TIFF OMITTED] TR19OC07.005

    H. How do we evaluate the need for supplemental daily enteral 
feeding via a gastrostomy?
    1. General. Infants and young children may have anatomical, 
neurological, or developmental disorders that interfere with their 
ability to feed by mouth, resulting in inadequate caloric intake to 
meet their growth needs. These disorders frequently result in the 
medical necessity to supplement caloric intake and to bypass the 
anatomical feeding route of mouth-throat-esophagus into the stomach.
    2. Children who have not attained age 3 and who require 
supplemental daily enteral nutrition via a feeding gastrostomy meet 
105.10 regardless of the medical reason for the gastrostomy. 
Thereafter, we evaluate growth impairment under 100.02, malnutrition 
under 105.08, or other medical or developmental disorder(s) 
(including the disorder(s) that necessitated gastrostomy placement) 
under the appropriate listing(s).
    I. How do we evaluate esophageal stricture or stenosis? 
Esophageal stricture or stenosis (narrowing) from congenital atresia 
(absence or abnormal closure of a tubular body organ) or destructive 
esophagitis may result in malnutrition or the need for gastrostomy 
placement, which we evaluate under 105.08 or 105.10. Esophageal 
stricture or stenosis may also result in complications such as 
pneumonias due to frequent aspiration, or difficulty in maintaining 
nutritional status short of listing-level severity. While none of 
these complications may be of such severity that they would meet the 
criteria of another listing, the combination of impairments may 
medically equal the severity of a listing or functionally equal the 
listings.
    J. What do we mean by the phrase ``consider under a disability 
for 1 year''? We use the phrase ``consider under a disability for 1 
year'' following a specific event in 105.02, 105.05A, and 105.09 to 
explain how long your impairment can meet the requirements of those 
particular listings. This phrase does not refer to the date on which 
your disability began, only to the date on which we must reevaluate 
whether your impairment continues to meet a listing or is otherwise 
disabling. For example, if you have received a liver transplant, you 
may have become disabled before the transplant because of chronic 
liver disease. Therefore, we do not restrict our determination of 
the onset of disability to the date of the specified event. We will 
establish an onset date earlier than the date of the specified event 
if the evidence in your case record supports such a finding.
    K. How do we evaluate impairments that do not meet one of the 
digestive disorder listings?
    1. These listings are only examples of common digestive 
disorders 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. If you have hepatitis B or C and you are depressed, we will 
evaluate your impairment under 112.04.
    b. If you have multiple congenital abnormalities, we will 
evaluate your impairment(s) under the criteria in the listings for 
impairments that affect multiple body systems (110.00) or the 
criteria of listings in other affected body systems.
    c. If you have digestive disorders that interfere with intake, 
digestion, or absorption of nutrition, and result in a reduction in 
your rate of growth, and your impairment does not satisfy the 
criteria in the malnutrition listing (105.08), we will evaluate your 
impairment under the growth impairment listings (100.00).
    2. If you have a severe medically determinable impairment(s) 
that does not meet a listing, we will determine whether your 
impairment(s) medically equals a listing. (See Sec.  416.926.) If 
your impairment(s) does not meet or medically equal a listing, you 
may or may not have an impairment(s) that functionally equals the 
listings. (See Sec.  416.926a.) When we decide whether you continue 
to be disabled, we use the rules in Sec.  416.994a.
    105.01 Category of Impairments, Digestive System
    105.02 Gastrointestinal hemorrhaging from any cause, requiring 
blood transfusion (with or without hospitalization) of at least 10 
cc of blood/kg of body weight, and occurring at least three times 
during a consecutive 6-month period. The transfusions must be at 
least 30 days apart within the 6-month period. Consider under a 
disability for 1 year following the last documented transfusion; 
thereafter, evaluate the residual impairment(s).
    105.03 [Reserved]
    105.04 [Reserved]
    105.05 Chronic liver disease, with:
    A. Hemorrhaging from esophageal, gastric, or ectopic varices or 
from portal hypertensive gastropathy, demonstrated by endoscopy, x-
ray, or other appropriate medically acceptable imaging, resulting in 
hemodynamic instability as defined in 105.00D5, and requiring 
hospitalization for transfusion of at least 10 cc of blood/kg of 
body weight. Consider under a disability for 1 year following the 
last documented transfusion; thereafter, evaluate the residual 
impairment(s).

OR

    B. Ascites or hydrothorax not attributable to other causes, 
despite continuing treatment as prescribed, present on at least two 
evaluations at least 60 days apart within a consecutive 6-month 
period. Each evaluation must be documented by:
    1. Paracentesis or thoracentesis; or
    2. Appropriate medically acceptable imaging or physical 
examination and one of the following:
    a. Serum albumin of 3.0 g/dL or less; or
    b. International Normalized Ratio (INR) of at least 1.5.

OR

    C. Spontaneous bacterial peritonitis with peritoneal fluid 
containing an absolute neutrophil count of at least 250 cells/mm 
3.

OR


[[Page 59431]]


    D. Hepatorenal syndrome as described in 105.00D8, with one of 
the following:
    1. Serum creatinine elevation of at least 2 mg/dL; or
    2. Oliguria with 24-hour urine output less than 1 mL/kg/hr; or
    3. Sodium retention with urine sodium less than 10 mEq per 
liter.

OR

    E. Hepatopulmonary syndrome as described in 105.00D9, with:
    1. Arterial oxygenation (PaO2,) on room 
air of:
    a. 60 mm Hg or less, at test sites less than 3000 feet above sea 
level, or
    b. 55 mm Hg or less, at test sites from 3000 to 6000 feet, or
    c. 50 mm Hg or less, at test sites above 6000 feet; or
    2. Documentation of intrapulmonary arteriovenous shunting by 
contrast-enhanced echocardiography or macroaggregated albumin lung 
perfusion scan.

OR

    F. Hepatic encephalopathy as described in 105.00D10, with 1 and 
either 2 or 3:
    1. Documentation of abnormal behavior, cognitive dysfunction, 
changes in mental status, or altered state of consciousness (for 
example, confusion, delirium, stupor, or coma), present on at least 
two evaluations at least 60 days apart within a consecutive 6-month 
period; and
    2. History of transjugular intrahepatic portosystemic shunt 
(TIPS) or any surgical portosystemic shunt; or
    3. One of the following occurring on at least two evaluations at 
least 60 days apart within the same consecutive 6-month period as in 
F1:
    a. Asterixis or other fluctuating physical neurological 
abnormalities; or
    b. Electroencephalogram (EEG) demonstrating triphasic slow wave 
activity; or
    c. Serum albumin of 3.0 g/dL or less; or
    d. International Normalized Ratio (INR) of 1.5 or greater.

OR

    G. End Stage Liver Disease, with:
    1. For children 12 years of age or older, SSA CLD scores of 22 
or greater calculated as described in 105.00D11a. Consider under a 
disability from at least the date of the first score.
    2. For children who have not attained age 12, SSA CLD-P scores 
of 11 or greater calculated as described in 105.00D11b. Consider 
under a disability from at least the date of the first score.

OR

    H. Extrahepatic biliary atresia as diagnosed on liver biopsy or 
intraoperative cholangiogram. Consider under a disability for 1 year 
following the diagnosis; thereafter, evaluate the residual liver 
function.
    105.06 Inflammatory bowel disease (IBD) documented by endoscopy, 
biopsy, appropriate medically acceptable imaging, or operative 
findings with:
    A. Obstruction of stenotic areas (not adhesions) in the small 
intestine or colon with proximal dilatation, confirmed by 
appropriate medically acceptable imaging or in surgery, requiring 
hospitalization for intestinal decompression or for surgery, and 
occurring on at least two occasions at least 60 days apart within a 
consecutive 6-month period;

OR

    B. Two of the following despite continuing treatment as 
prescribed and occurring within the same consecutive 6-month period:
    1. Anemia with hemoglobin less than 10.0 g/dL, present on at 
least two evaluations at least 60 days apart; or
    2. Serum albumin of 3.0 g/dL or less, present on at least two 
evaluations at least 60 days apart; or
    3. Clinically documented tender abdominal mass palpable on 
physical examination with abdominal pain or cramping that is not 
completely controlled by prescribed narcotic medication, present on 
at least two evaluations at least 60 days apart; or
    4. Perineal disease with a draining abscess or fistula, with 
pain that is not completely controlled by prescribed narcotic 
medication, present on at least two evaluations at least 60 days 
apart; or
    5. Need for supplemental daily enteral nutrition via a 
gastrostomy or daily parenteral nutrition via a central venous 
catheter. (See 105.10 for children who have not attained age 3.)
    105.07 Short bowel syndrome (SBS), due to surgical resection of 
more than one-half of the small intestine, with dependence on daily 
parenteral nutrition via a central venous catheter (see 105.00F).
    105.08 Malnutrition due to any digestive disorder with:
    A. Chronic nutritional deficiency despite continuing treatment 
as prescribed, present on at least two evaluations at least 60 days 
apart within a consecutive 6-month period, and documented by one of 
the following:
    1. Anemia with hemoglobin less than 10.0 g/dL; or
    2. Serum albumin of 3.0 g/dL or less; or
    3. Fat-soluble vitamin, mineral, or trace mineral deficiency;

AND

    B. Growth retardation documented by one of the following:
    1. For children who have not attained age 2, multiple weight-
for-length measurements that are less than the third percentile on 
the CDC's most recent weight-for-length growth charts, documented at 
least three times within a consecutive 6-month period; or
    2. For children age 2 and older, multiple Body Mass Index (BMI)-
for-age measurements that are less than the third percentile on the 
CDC's most recent BMI-for-age growth charts, documented at least 
three times within a consecutive 6-month period.
    105.09 Liver transplantation. Consider under a disability for 1 
year following the date of transplantation; thereafter, evaluate the 
residual impairment(s) (see 105.00D13 and 105.00J).
    105.10 Need for supplemental daily enteral feeding via a 
gastrostomy due to any cause, for children who have not attained age 
3; thereafter, evaluate the residual impairment(s) (see 105.00H).
* * * * *

PART 416--SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND 
DISABLED

Subpart I--[Amended]

0
7. Revise the authority citation for subpart I of part 416 to read as 
follows:

    Authority: Secs. 221(m), 702(a)(5), 1611, 1614, 1619, 1631(a), 
(c), (d)(1), and (p) and 1633 of the Social Security Act (42 U.S.C. 
421(m), 902(a)(5), 1382, 1382c, 1382h, 1383(a), (c), (d)(1), and 
(p), and 1383b); secs. 4(c) and 5, 6(c)-(e), 14(a), and 15, Pub. L. 
98-460, 98 Stat. 1794, 1801, 1802, and 1808 (42 U.S.C. 421 note, 423 
note, and 1382h note).


Sec.  416.924b  [Amended]

0
8. In Sec.  416.924b(b)(3), remove the reference ``Sec.  416.924a(m)(7) 
or (8)'' and insert the reference ``Sec.  416.926a(m)(6) or (7)'' in 
its place.


Sec.  416.926a  [Amended]

0
9. In Sec.  416.926a, remove paragraphs (m)(3) and (m)(10) and 
redesignate paragraphs (m)(4), (m)(5), (m)(6), (m)(7), (m)(8), and 
(m)(9) as paragraphs (m)(3), (m)(4), (m)(5), (m)(6), (m)(7), and 
(m)(8).

 [FR Doc. E7-20235 Filed 10-18-07; 8:45 am]
BILLING CODE 4191-02-P