Revised Medical Criteria for Evaluating Digestive Disorders, 59398-59431 [E7-20235]

Agencies

• Social Security Administration

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



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Part III





Social Security Administration





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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

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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.

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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 https://
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 https://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.

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     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

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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.

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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 lis