Rule: Social Security Benefits: Federal Old Age, Survivors, and Disability Insurance&#8212 Digestive System Impairments Medical Criteria Evaluation

Friday,
October 19, 2007
Part III
Social Security
Administration
20 CFR Parts 404 and 416
Revised Medical Criteria for Evaluating
Digestive Disorders; Final Rule
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59398 Federal Register / Vol. 72, No. 202 / Friday, October 19, 2007 / Rules and Regulations
SOCIAL SECURITY ADMINISTRATION • Published final rules on April 24, As is our usual practice when we
2002, entitled Technical Revisions to make changes to our regulations, we
20 CFR Parts 404 and 416 Medical Criteria for Determinations of will apply these final rules on or after
Disability (67 FR 20018). In those final their effective date when we make a
[Docket No. SSA 2006–0094]
rules, we added listings 5.09 and 105.09 determination or decision, including
RIN 0960–AF28 for liver transplantation. We also made those claims in which we make a
minor technical changes to our listings determination or decision after a
Revised Medical Criteria for Evaluating to include references to modern imaging remand to us from a Federal court. With
Digestive Disorders techniques. These final rules do not respect to claims in which we have
make substantive changes to the rules made a final decision and that are
AGENCY: Social Security Administration.
we published on April 24, 2002, pending judicial review in Federal
ACTION: Final rule. although we are making minor editorial court, we expect that the court would
SUMMARY: We are revising the criteria in
changes. review the Commissioner’s final
the Listing of Impairments (the listings) • Published a notice on November 8, decision in accordance with the rules in
that we use to evaluate claims involving 2004, providing a 60-day extension of effect at the time the final decision of
digestive disorders. We apply these the comment period on the NPRM for the Commissioner was issued. If a court
criteria when you claim benefits based the limited purpose of accepting reverses the Commissioner’s final
on disability under title II and title XVI comments about the proposals regarding decision and remands the case for
of the Social Security Act (the Act). The chronic liver disease (69 FR 64702). We further administrative proceedings after
revisions reflect advances in medical explain this extension in more detail in the effective date of these final rules, we
knowledge, methods of evaluating the public comments section of this will apply the provisions of these final
digestive disorders, treatment, and our preamble. rules to the entire period at issue in the
program experience. We are also • Held an outreach meeting in claim in our new decision issued
removing listings that are redundant Cambridge, Massachusetts on November pursuant to the court’s remand.
because they only refer to other listings, 17, 2004, regarding our listings for How long will these rules be in effect?
and we are making other conforming chronic liver disease. We describe this
meeting in more detail in the public These rules will be in effect for 5
changes. years after the date they become
comments section of this preamble.
These rules are effective
DATES: effective, unless we extend them or
December 18, 2007. Why are we revising the listings for revise and issue them again.
FOR FURTHER INFORMATION CONTACT: digestive disorders?
What general changes are we making
James Julian, Director, Office of Medical We reviewed the prior digestive that affect both the adult and childhood
Policy, Social Security Administration, disorder listings and determined that listings for digestive disorders?
4470 Annex Building, 6401 Security they should be revised in light of our
Boulevard, Baltimore, Maryland 21235– We are clarifying the listing criteria
program experience and advances in and making them easier to use by:
6401, 410–965–4015. For information medical knowledge, methods of • Removing reference listings and,
on eligibility or filing for benefits, call evaluating digestive disorders, and when appropriate, providing guidance
our national toll-free number 1–800– treatment. We last published final rules in the introductory text of the listings.
772–1213 or TTY 1–800–325–0778, or comprehensively revising the digestive Reference listings are listings that are
visit our Internet Web site, Social disorder listings in the Federal Register met by satisfying the criteria of another
Security Online, at http:// on December 6, 1985 (50 FR 50068). In listing. For example, an impairment
www.socialsecurity.gov. the introductory text to those rules, we could meet prior listing 5.03, Stricture,
SUPPLEMENTARY INFORMATION: stated our intention to periodically stenosis, or obstruction of the
review and update these listings due to esophagus, with weight loss ‘‘as
Electronic Version medical advances in treatment and our described under listing 5.08.’’ Prior
The electronic file of this document is program experience. listing 5.08 required weight loss of a
available on the date of publication in What do we mean by ‘‘final rules’’ and specific amount due to ‘‘any persisting
the Federal Register at http:// ‘‘prior rules’’? gastrointestinal disorder.’’ Therefore,
www.gpoaccess.gov/fr/index.html. prior listing 5.03 was redundant because
Even though these rules will not go we could also evaluate weight loss from
Background into effect until 60 days after stricture, stenosis, or obstruction of the
We are revising and making final the publication of this notice, for clarity we esophagus under listing 5.08 alone.
rules we proposed in the Notice of refer to the changes we are making here • Removing or updating outdated
Proposed Rulemaking (NPRM) as the ‘‘final rules’’ and to the rules that listings.
published in the Federal Register on will be changed by these final rules as • Adding criteria to the listing for
November 14, 2001 (66 FR 57009). We the ‘‘prior rules.’’ chronic liver diseases and expanding
provide a summary of the provisions of the guidance in the introductory text on
When will we start to use these final
the final rules below, with an how we evaluate these diseases,
rules?
explanation of the changes we have including specific guidance on chronic
made from the text in the NPRM. We We will start to use these final rules viral hepatitis infections.
also provide summaries of the public on their effective date. We will continue • Revising and adding criteria to the
comments and our reasons for adopting to use our prior rules until the effective listing for inflammatory bowel diseases
or not adopting the recommendations in date of these final rules. When these and expanding the introductory text to
these comments in the section, ‘‘Public final rules become effective, we will include guidance on how we evaluate
Comments.’’ The final rule language apply them to new applications filed on these digestive disorders.
follows the public comments. or after the effective date of these rules • Adding a listing for short bowel
After we published the NPRM, we and to claims pending before us, as we syndrome and providing guidance in
also: describe below. the introductory text for this disorder.
Federal Register / Vol. 72, No. 202 / Friday, October 19, 2007 / Rules and Regulations 59399
• Expanding the introductory text to respond to treatment; therefore, their we made to the listings. Therefore, we
include guidance on how we consider severity should be evaluated in the removed all of proposed 5.00C. We
the effects of treatment. context of prescribed treatment. We explain the reasons for the changes to
• Providing general guidance in the moved this information to 5.00C, ‘‘How the listings later in this preamble.
introductory text explaining how we do we consider the effects of We explain how we consider the
evaluate digestive disorders that do not treatment?’’ where it more logically fits. effects of treatment in final 5.00C. This
meet these listings. section is an expansion of proposed
5.00B—What documentation do we
• Making nonsubstantive editorial need?
5.00D. It includes six paragraphs that
changes to update the medical address treatment issues, rather than the
terminology in the listings and to be In this new section, we include three paragraphs we proposed. As we
consistent with plain language examples of the types of clinical and have already noted, we moved the
guidelines. laboratory findings that should be part additional paragraphs from other
We discuss other changes in the of the longitudinal evidence. This sections to present the information more
listings below, in our detailed section also includes two sentences logically.
explanation of the revised listings. describing appropriate medically
acceptable imaging that were not in the General Information About Final 5.00D
How are we changing the introductory NPRM, but that we added in the Through 5.00G
text to the listings for evaluating aforementioned final rules making In the NPRM, proposed 5.00F was
digestive disorders in adults? technical, but not policy, changes to our titled ‘‘What are our guidelines for
5.00 Digestive System listings. We revised the sentence evaluating specific digestive
describing medically acceptable imaging impairments?’’ Proposed 5.00F1
We are revising the introductory text so that it more appropriately reflects addressed malnutrition and weight loss,
for this body system to provide imaging techniques used for digestive and proposed 5.00F2 addressed chronic
additional guidance for evaluating disorders. We also moved to this section liver disease. In these final rules, we are
digestive disorders and to update its a revised version of the first sentence of greatly expanding the introductory text
medical terminology. We are also proposed 5.00C2, which explains that from the NPRM in response to public
removing references to digestive the specific findings required by these comments and adding more discussion
disorders and complications of digestive listings must occur within the period we about digestive disorders, especially
disorders, such as peptic ulcer disease, are considering in connection with an chronic liver disease and inflammatory
fistulae, and abscesses, that generally individual’s application or continuing bowel disease. Since we are including
are not of listing-level severity. disability review. significantly more information in these
(However, as we explain below, we are In response to public comments we final rules, we are addressing each kind
including fistulae and abscesses as describe later in this preamble, we of digestive disorder in its own separate
criteria in final listing 5.06 for removed the sentence in proposed section. Also, the guidance about
inflammatory bowel disease.) 5.00B1 explaining that we usually need specific disorders under proposed 5.00F
We are including relevant material longitudinal evidence covering a period was not in the order of the proposed
from prior 5.00A in final 5.00A and of at least 6 months of observations and listings. In the final rules, we are
final 5.00C. treatment unless we can make a fully providing guidance that generally
We are updating and moving relevant favorable determination or decision follows the structure of the final listings.
material from prior 5.00B to final 5.00G. without it. Instead, we are providing Thus:
We are moving relevant material from timeframes for the evidence • Final 5.00D addresses chronic liver
prior 5.00C to final 5.00E. We are requirements in each listing. disease (final listing 5.05);
removing the portion of prior 5.00C that We moved proposed 5.00B2, which • Final 5.00E addresses inflammatory
dealt with peptic ulcer disease because explained how we evaluate claims when bowel disease (final listing 5.06);
advances in diagnosis, evaluation, and an individual has not received ongoing • Final 5.00F addresses short bowel
treatment of this impairment make the treatment or does not have an ongoing syndrome (final listing 5.07); and
surgical interventions discussed in the relationship with the medical • Final 5.00G addresses weight loss
prior section (including gastrectomy, community despite the existence of a due to any digestive disorder (final
vagotomy, and pyloroplasty) much less severe impairment, to final 5.00C where listing 5.08).
common. it fits more logically with our discussion
Following is a detailed, section-by- 5.00D—How do we evaluate chronic
of treatment issues.
section explanation of the final liver disease?
introductory text material. 5.00C—How do we consider the effects In final 5.00D (proposed 5.00F2), we
of treatment? define chronic liver disease, provide
5.00A—What kinds of disorders do we In the NPRM, proposed 5.00C was examples of it, and describe its
consider in the digestive system? titled, ‘‘How do we evaluate digestive manifestations. In response to hundreds
This section revises prior 5.00A. We disorders that require recurring or of public comments regarding hepatitis
list the major types of digestive persistent findings?’’ Proposed 5.00C1 C, we are greatly expanding this section
disorders included in these listings and defined ‘‘recurring’’ and ‘‘persisting’’ as to explain how we evaluate chronic
provide an example of a complication used in listings 5.02, 5.05, 5.06, and viral hepatitis, including chronic
that may result from them. In the 5.08, and proposed 5.00C2 explained hepatitis B and C infections, and we
NPRM, we proposed to include when the ‘‘events’’ required to satisfy describe extrahepatic manifestations of
information in this section from prior the listings must occur. In these final these infections. In addition, we include
5.00C about colostomy and ileostomy. rules, we removed the references to guidance for considering the effects of
However, we moved this information to recurring or persistent findings from the specific treatment modalities for
final 5.00E as part of the general digestive listings. We also moved the hepatitis B and C infections. We also
reorganization of the introductory text. first sentence of 5.00C2 to final 5.00B. present information on conditions that
We also proposed to explain that We no longer need the second sentence we include in the chronic liver disease
gastrointestinal impairments frequently of proposed 5.00C2 because of changes listing (that is, gastrointestinal
hemorrhage, ascites or hydrothorax, We are also not including the are at the level specified in the listing,
spontaneous bacterial peritonitis, statement from proposed 5.00F2d that it is not necessary to quantify the
hepatorenal syndrome, liver function tests ‘‘must not be relied ascites.
hepatopulmonary syndrome, hepatic upon in isolation’’ because it is • Final 5.00D7, D8, and D9 are also
encephalopathy, end stage liver disease, unnecessary. In final 5.00D3c, we are
new in these final rules. In response to
and liver transplantation). also expanding the rules from what we
Final 5.00D contains 12 sections: comments, we are including listing
had proposed to include information on
• Final 5.00D1, D2, and D3 are a documenting chronic liver disease with criteria in final listing 5.05 for three
reorganization of the information a liver biopsy or imaging studies. serious complications of chronic liver
presented in proposed 5.00F2(a), F2(b), • Final 5.00D4 is new; there was no disease: Spontaneous bacterial
and F2(d). corresponding section in the NPRM. We peritonitis (final listing 5.05C);
• In final 5.00D1, we define chronic added it in response to hundreds of hepatorenal syndrome (final listing
liver disease and name the comments concerning the growing 5.05D); and hepatopulmonary syndrome
manifestations of chronic liver disease incidence of hepatitis. In final 5.00D4a, (final listing 5.05E). Each new section
that we consider under these listings. we provide general information about explains how the condition is diagnosed
We removed the phrase in proposed chronic viral hepatitis infections. In and the documentation requirements for
5.00F2 indicating that chronic liver final 5.00D4b, we provide information the new listings.
disease must be ‘‘expected to continue about chronic hepatitis B infection. In
for 12 months’’ because it is • In final 5.00D10, we provide
final 5.00D4c, we provide detailed
unnecessary. Under our general rules for guidance for evaluating hepatic
information about chronic hepatitis C
evaluating disability, an impairment encephalopathy under final listing
infection, including a paragraph
must meet the duration requirement. explaining adverse effects of treatment 5.05F. As noted earlier, we added this
• We also removed the phrase in that may contribute to a finding of listing in response to comments. In
proposed 5.00F2d explaining that we disability. In final 5.00D4d, we provide 5.00D10a, we explain how hepatic
would ‘‘assess impairment due to information about the extrahepatic encephalopathy is diagnosed and
hepatic encephalopathy under the manifestations of hepatitis B and C identify the documentation
criteria for the appropriate mental infections that may result in, or requirements for the new listing. In final
disorder or neurological listing(s).’’ In contribute to, a finding of disability. 5.00D10b, we explain that we will not
response to public comments, we are • Final 5.00D5 corresponds to evaluate acute encephalopathy under
adding a listing for hepatic proposed 5.00F2c. In it, we provide listing 5.05F if it results from conditions
encephalopathy (final listing 5.05F). guidance for evaluating gastrointestinal other than chronic liver disease.
• Final 5.00D2 presents an expanded hemorrhages under final listings 5.02 • Final 5.00D11 is also new in these
list of examples of chronic liver disease, and 5.05A. As we explain in more detail final rules. In response to public
including some diseases, such as below, we have revised proposed comments, we added listing 5.05G, for
Wilson’s disease and chronic hepatitis, listings 5.02 and 5.05A in these final end stage liver disease (ESLD) with SSA
which we included in the heading of rules, and final 5.00D reflects the
Chronic Liver Disease (SSA CLD) scores
prior listing 5.05 but not in the heading changes to the listings. For example, in
of final listing 5.05. of 22 or greater. The SSA CLD
response to comments, we expanded the
• Final 5.00D3 is an expansion of scope of listing 5.05A to include calculation is a calculation we
proposed 5.00F2d. It has three hemorrhages from gastric or ectopic developed based on the Model for End
paragraphs that describe the symptoms varices and portal hypertensive Stage Liver Disease (MELD) calculation.
(5.00D3a), signs (5.00D3b), and gastropathy in addition to hemorrhages The MELD is a numerical scale
laboratory findings (5.00D3c) associated from esophageal varices. Also in developed for the United Network for
with the manifestations of chronic liver response to comments, we removed the Organ Sharing (UNOS) that is used for
disease. proposed criterion for ‘‘massive’’ liver allocation within the Organ
In response to a comment, we are hemorrhage requiring transfusion of at Procurement and Transplantation
including guidance in final 5.00D3a to least 5 units of blood in 48 hours. Network. The MELD score is based on
explain that symptoms may correlate Instead, final listing 5.05A requires objective and verifiable medical data,
poorly with the severity of chronic liver hemorrhaging which results in and estimates an individual’s risk of
disease. ‘‘hemodynamic instability,’’ which we dying while waiting for a liver
In final 5.00D3c, we are clarifying our describe in final 5.00D5. transplant. In final 5.00D11a, we
intent in proposed 5.00F2d, where we • In final 5.00D6, we provide explain that we will use the SSA CLD
explained that abnormal liver function guidance for evaluating ascites or score to evaluate your end stage liver
test findings may correlate poorly with hydrothorax under final listing 5.05B. In disease under final listing 5.05G. In
the clinical severity of liver disease. response to comments, we have revised final 5.00D11b–g, we explain how we
Although that guidance is applicable to proposed listing 5.05B; therefore, final calculate the SSA CLD score; for
liver function tests such as serum total 5.00D6 reflects the changes we made to example, what laboratory values we use,
bilirubin or liver enzyme levels, it is not that listing. We explain those changes when they must be obtained, and the
applicable to all tests indicative of liver later in this preamble. formula we use to do the calculation.
function. In final 5.00D3c, we now We also removed the statement in
explain that abnormally low serum proposed 5.00F2d that current imaging • Final 5.00D12 corresponds to
albumin or elevated International techniques are capable of identifying 5.00F2e and F2g in the NPRM. It
Normalized Ratio (INR) levels are even minimal amounts of ascites before explains how we evaluate liver
exceptions because they are indicators they can be detected on physical transplantation 1 year after the date of
of significant liver disease. As we note examination. We made this change the transplantation. The final rule is
below, we include criteria for because final listing 5.05B is met based similar to the proposed rule; we edited
abnormally low serum albumin and on laboratory findings coupled with it for clarity and expanded it slightly to
elevated INR in final listings 5.05B and documentation of the ascites or provide more information about when
5.05F. hydrothorax. If these laboratory findings liver transplantations are performed.
5.00E—How do we evaluate and weight measurements to BMI 5.00I—How do we evaluate impairments

inflammatory bowel disease (IBD)? removed the need to provide rules for that do not meet one of the digestive
In response to public comments, we rounding of height and weight disorder listings?
are greatly expanding the listing criteria measurements; therefore, we do not Final 5.00I is generally the same as
for inflammatory bowel disease, final include in these final rules the rules for proposed 5.00E, except that we include
listing 5.06, and adding a new section, rounding that were in proposed hepatitis B or C that results in
final 5.00E, to the introductory text to 5.00F1a–F1c. depression as an example of a digestive
provide guidance for evaluating IBD impairment we would evaluate in
under these expanded criteria. 5.00H—What do we mean by the phrase
another body system, instead of the
Final 5.00E contains four paragraphs: ‘‘consider under a disability for 1 year’’?
hepatic encephalopathy example we
• In final 5.00E1, we explain the included in proposed 5.00E1. This
Final 5.00H corresponds to proposed
general characteristics of IBD; example was no longer appropriate
• In final 5.00E2, we list common 5.00F2f; however, we revised it to make
clear that the phrase refers to the date because we have a listing for hepatic
symptoms, signs, and laboratory encephalopathy (5.05F) in the final
findings associated with IBD; on which we must determine whether
rules.
• In final 5.00E3, we describe some of an impairment continues to meet a
the more common extraintestinal listing or is otherwise disabling, not the How are we changing the listings for
manifestations of IBD affecting different date on which disability began. We evaluating digestive disorders in
body systems; and explain that we do not restrict our adults?
• In final 5.00E4, we explain how we finding about the onset date of disability
consider surgical procedures such as 5.01 Category of Impairments,
to the date of a specific qualifying event Digestive System
ileostomy and colostomy. Final 5.00E4 in a listing, such as a liver transplant.
corresponds to the first sentence of prior For example, many individuals who Removal of Redundant or Reference
5.00C and proposed 5.00A3. need liver transplants (final listing 5.09) Listings
5.00F—How do we evaluate short bowel have impairments that meet one of the We are removing four prior listings
syndrome (SBS)? criteria for chronic liver disease (final because they were reference listings
In response to public comments, we listing 5.05) before they have their liver and, therefore, were redundant. These
are adding a new listing for short bowel transplants. four listings were met by referring to the
syndrome, final listing 5.07, and a new In the proposed rules, we had requirements of prior listing 5.08:
section in the introductory text, final inadvertently included the explanation • 5.03—Stricture, stenosis, or
5.00F, to provide guidance for of the phrase ‘‘consider under a obstruction of the esophagus with
evaluating SBS under this listing. disability for 1 year’’ under the heading weight loss;
• 5.04D—Peptic ulcer disease with
5.00G—How do we evaluate weight loss for chronic liver disease; however, we
weight loss;
due to any digestive disorder? also use the phrase in final listing 5.02
• 5.06E—Chronic ulcerative or
for gastrointestinal hemorrhaging from
Final 5.00G corresponds to prior granulomatous colitis with weight loss;
any cause. Therefore, in the final rules, and
5.00B and proposed 5.00F1 and reflects
we explain the phrase in a section that • 5.07D—Regional enteritis with
changes we made to proposed listing
is independent of the discussion of weight loss.
5.08, discussed below. We are
simplifying the guidance from prior chronic liver disease, and we identify All of these impairments are still
5.00B about evaluating malnutrition and the three listings to which it applies. covered by final listing 5.08. Chronic
weight loss. Under the final rules, it is In proposed 5.00F2f, we had also ulcerative or granulomatous colitis and
sufficient for our purposes that the stated that the phrase was a ‘‘statement regional enteritis are also covered by
weight loss result from any medically about the expected duration of final listing 5.06. We no longer mention
determinable digestive disorder. We are disability.’’ In reviewing that language, them explicitly in these final rules
also revising the heading of final 5.00G we realized that it could have been because they have been replaced by the
to refer only to weight loss, instead of misunderstood to mean that we more encompassing term ‘‘inflammatory
the proposed reference to malnutrition presume that an individual will no bowel disease.’’
and weight loss, to better reflect the longer be disabled after 1 year. That was Prior listing 5.05E, hepatic
content of the section. not our intent. Rather, we intended to encephalopathy, was also a reference
We revised proposed listing 5.08 to listing, referring to listing 12.02. In the
indicate only that after 1 year the
use Body Mass Index (BMI) to evaluate NPRM, we proposed to remove the
impairment would no longer meet the
weight loss instead of using height and listing and to add language in proposed
requirements of the particular listing
weight measurements by gender. BMI is sections 5.00E1 and 5.00F2b that
that includes the criterion. The reminded adjudicators to evaluate the
the measurement recommended by the
impairment may still be disabling at the impairment under the criteria for the
Centers for Disease Control and
Prevention (CDC) to determine end of the period because it may meet appropriate mental disorder or
appropriate weight for height. In final or medically equal another listing or neurological listing. However, in
5.00G1, we explain that we use BMI to result in a residual functional capacity response to many public comments, we
evaluate weight loss due to any that is consistent with a finding of decided to remove the proposed
digestive disorder under listing 5.08 and disability. Also, when we consider guidance and to provide a new listing
to evaluate lesser weight loss from IBD whether an impairment continues to be specifically for hepatic encephalopathy
under listing 5.06B. The latter is one of disabling, we apply the medical in the digestive listings, final listing
the new criteria that we added to the improvement review standard in 5.05F. Therefore, while we are still
IBD listing in response to public §§ 404.1594 and 416.994. For these removing prior reference listing 5.05E,
comments. reasons, we are not including the we are including a different listing for
In final 5.00G2, we explain how we statement in these final rules. hepatic encephalopathy in these final
calculate BMI. The change from height rules.
We are also removing the following removing this listing because a liver weight equal to or less than the values
prior listings because medical biopsy, while confirming the presence specified in Table III or IV and one of
knowledge, methods of evaluating of liver disease, does not correlate with the listed abnormal laboratory findings
digestive disorders, advances in any specific level of impairment present on repeated examinations. This
treatment, and our program experience severity or decrease in ability to listing allowed a lesser level of weight
indicate that they are no longer function. We assess the clinical findings loss than that required to meet listing
appropriate indicators of listing-level described in prior listings 5.05F1 and F3 5.08A when accompanied by one of the
severity. There has been significant in other final listings, and we are additional listed findings. Those
progress in the treatment of these removing the requirement for elevated findings, however, did not correlate
digestive disorders. Many of these serum total bilirubin level in prior with any specific level of impairment
disorders can be controlled or resolved listing 5.05F2 because it does not severity or decrease of ability to
and thus are less likely to be of listing- sufficiently demonstrate impairment function that would be an accurate
level severity. Even if listing-level severity or correlate with the ability to indicator of listing-level severity.
severity is initially present, the 12- function. However, in response to public
month statutory duration requirement • 5.06A—Chronic ulcerative or comments, we are including a 10
will often not be met. granulomatous colitis with recurrent percent weight loss from baseline as one
• 5.04—Peptic ulcer disease bloody stools documented on repeated of the criteria that can be used to meet
(demonstrated by endoscopy or other examinations and anemia manifested by final listing 5.06 for individuals who
appropriate medically acceptable hematocrit of 30 percent or less. These have IBD.
imaging). Advances in medical and criteria alone were not appropriate The following is a detailed
surgical management have made less indicators of listing-level severity. explanation of the final listings.
common many complications from However, we have incorporated a
peptic ulcer disease, such as recurrent criterion for anemia in final listing 5.06, Listing 5.02—Gastrointestinal
ulceration (prior listing 5.04A), fistula the new listing for IBD that we added in Hemorrhaging From Any Cause,
formation (prior listing 5.04B), and response to public comments. Requiring Blood Transfusion
recurrent obstruction (prior listing • 5.06B and 5.07—Persistent or We are expanding this listing to
5.04C). Treatment often results in recurrent systemic manifestations, such
include ‘‘gastrointestinal hemorrhage
significant improvement, therefore the as arthritis, iritis, fever, or liver
from any cause’’ instead of the prior
prior listing criteria for these dysfunction due to chronic ulcerative or
listing’s ‘‘upper gastrointestinal
impairments are no longer appropriate granulomatous colitis or regional
hemorrhage from undetermined cause.’’
indicators of listing-level severity. enteritis. These listings required only
We are also revising the severity
• 5.05B—Chronic liver disease with the presence of a systemic manifestation
criterion in this listing from anemia
performance of a shunt operation for in another body system or organ,
with a persistent hematocrit level of 30
esophageal varices. When we first without regard to degree of severity or
percent or less, to a requirement for
published this listing, only surgical impact on functioning. Therefore, they
gastrointestinal hemorrhages that
shunts involving extensive abdominal were not appropriate indicators of
surgery were available. These surgeries listing-level severity. However, in require blood transfusions of at least 2
were not usually performed until the response to public comments described units of blood per transfusion, occurring
chronic liver disease became serious below, we are including examples of at least three times, at least 30 days
enough to justify the risks associated significant extraintestinal apart, during a consecutive 6-month
with prolonged surgery and anesthesia. manifestations in final 5.00E3 with period. A hematocrit level by itself is
More recently, transjugular intrahepatic instructions to our adjudicators to generally not an appropriate indicator of
portosystemic shunts (TIPS), which are consider these manifestations when the severity of gastrointestinal
performed with minimal anesthesia and determining whether the individual has hemorrhage, and as we have already
with fewer complications, have largely an impairment(s) that meets or noted, does not necessarily correlate
replaced abdominal surgical shunts in medically equals another listing and with inability to function.
treating the complications of portal when assessing residual functional In these final rules, we are clarifying
hypertension, such as bleeding capacity. The examples include the proposed rule to explain that an
gastroesophageal varices or refractory arthritis, iritis, and other effects. individual does not have to be
ascites. However, in the final listing for • 5.06C and 5.07C—Intermittent hospitalized for transfusions under this
hepatic encephalopathy, final listing obstruction due to intractable abscess, listing. We did not indicate whether
5.05F, we are adding a criterion for a fistula formation, or stenosis as a result hospitalization was required in the
history of TIPS in combination with of chronic ulcerative or granulomatous proposed rule. Therefore, this is only an
other findings that describe an colitis or regional enteritis. Advances in editorial change for clarity.
impairment that is of listing-level surgical treatment have improved the The proposed listing indicated in a
severity. management of these disorders, thus parenthetical statement that ‘‘[a]ll
• 5.05C—Chronic liver disease with these listings are no longer appropriate incidents [hemorrhages] within a
specific levels of serum total bilirubin. indicators of listing-level severity. consecutive 14-day period constitute
Prior listing 5.05C required only a However, in final listing 5.06B, we one episode.’’ In the final listing, we are
persistently elevated serum total include intestinal obstruction, abscess, revising this statement by removing
bilirubin level. We are removing this fistula, and stenosis as criteria that can references to ‘‘incidents’’ and
listing because this laboratory finding satisfy the requirements of the listing. ‘‘episodes’’ and instead simply using the
alone does not correlate sufficiently • 5.06D—Recurrence of findings in word ‘‘transfusions,’’ since transfusions
with the ability to function. listing 5.06A, B, or C after total are the indicators of severity. Also, in
• 5.05F—Chronic liver disease with colectomy. We are removing this listing response to a public comment, we are
liver biopsy. This listing required consistent with our removal of listings increasing the length of time between
confirmation of chronic liver disease by 5.06A, B, and C. blood transfusions (described as
a liver biopsy, with another specified • 5.08B—Weight loss due to any ‘‘episodes’’ in the proposed rule) from
clinical or laboratory finding. We are persisting digestive disorder, with 14 days to 30 days.
Since improvements in medical Final listing 5.05B corresponds to a consecutive 6-month period, with
treatment may resolve the frequency of prior listing 5.05D, ascites due to associated physical signs or laboratory
hemorrhages and thus the overall chronic liver disease. In response to findings, occurring with the same
severity of the impairment, we indicate comments, we are also including frequency and during the same time
that we will consider an individual to hydrothorax in the listing because period; or a history of a TIPS or any
be under a disability for 1 year ascitic fluid can collect in the chest surgical portosystemic shunt procedure.
following the last documented cavity and result in a very serious • In response to comments that
transfusion. After that, we will evaluate impairment. Therefore, we are including individuals on liver transplant lists
the residual impairment(s). thoracentesis in the documentation should qualify, we are adding another
requirements in final listing 5.05B1 new listing, final listing 5.05G, for
Listing 5.05—Chronic Liver Disease because it provides a definitive evaluating individuals with ESLD. We
We are replacing prior listing 5.05 diagnosis of hydrothorax, just as are using an SSA CLD score criterion as
with criteria that more accurately reflect paracentesis provides a definitive an objective means to measure listing-
listing-level severity. diagnosis of ascites. level severity. As discussed above, we
• We are removing the parenthetical As in the NPRM, we are revising the based the SSA CLD calculation on the
examples of chronic liver diseases from required time period in which the MELD calculation used by UNOS to
the heading of prior listing 5.05 because evaluations showing ascites or prioritize individuals ages 12 and over
these references could have been hydrothorax must occur from 5 months on a national liver transplantation list
misinterpreted to mean that we to 6 months because, in our experience, according to the severity of their liver
included only those specific conditions a 6-month period enables us to make a disease. (There is also a Pediatric End
under the listing. However, in response more reliable prediction of duration of Stage Liver Disease scoring system,
to comments, we continue to use an impairment of listing-level severity. called PELD, for children under age 12.
Wilson’s disease and chronic hepatitis We also are requiring that evaluations We have developed an SSA Chronic
as examples of chronic liver diseases be done at least 60 days apart within the Liver Disease—Pediatric (SSA CLD–P)
that are covered by final listing 5.05 in 6-month period to substantiate the calculation based on that system that we
final 5.00D2 of the introductory text. In chronic nature of the impairment. have included in the part B listings, as
In response to public comments, final we explain below.) The SSA CLD score
a change from the NPRM, and in
listing 5.05B2 now requires determination relies only on objective
response to many comments, we are
documentation of ascites or hydrothorax criteria, with standardized laboratory
revising the heading of the listing to
by physical examination or by determinations that are readily available
refer to ‘‘chronic liver disease’’ only. We
appropriate medically acceptable and reproducible.
removed ‘‘and cirrhosis of any kind’’
imaging, but not both, as we proposed We did not agree that all individuals
from the heading because cirrhosis is a
in the NPRM. However, if the ascites or on transplant lists should qualify under
form of chronic liver disease.
hydrothorax is documented by physical our listings because the threshold
• In final listing 5.05A, we are examination or imaging rather than criteria for placement on a transplant
expanding the scope of prior and paracentesis or thoracentesis, we require list vary widely throughout the country
proposed listing 5.05A in response to additional laboratory findings that and some individuals are placed on
comments to include hemorrhaging confirm very serious chronic liver transplantation lists well before they
from esophageal, gastric, or ectopic disease. As in proposed listing 5.05B2a, have listing-level impairments. In the
varices, or from portal hypertensive we require serum albumin of 3.0 g/dL or final rule, we provide that a SSA CLD
gastropathy. The proposed listing less. In response to public comments, score of 22 or greater meets the listing.
required ‘‘massive’’ hemorrhage we changed the proposed criterion for a We chose this score based on the
requiring ‘‘5 units of blood in 48 hours.’’ measure of prothrombin time to a clinical severity represented by the
In response to comments, we changed criterion for an elevated International laboratory values contained in the SSA
the requirement for ‘‘massive’’ Normalized Ratio (INR) of at least 1.5 in CLD score.
hemorrhage to hemorrhaging that results final listing 5.05B2b. The public For final listing 5.05G, we require two
in hemodynamic instability, and we comments correctly indicated that INR calculations of SSA CLD scores, at least
changed the transfusion requirements is a more widely used study. 60 days apart, and that the scores must
from the proposed ‘‘5 units of blood in • In response to public comments, we be calculated within a consecutive 6-
48 hours’’ to ‘‘at least 2 units of blood.’’ are also adding three new listings for month period, consistent with other
We chose 2 units of blood because this serious complications of chronic liver provisions in these final rules.
is the minimum amount of blood that is disease: Final listing 5.05C for
usually transfused. We define spontaneous bacterial peritonitis; final Listing 5.06—Inflammatory Bowel
‘‘hemodynamic instability’’ in 5.00D5. listing 5.05D for hepatorenal syndrome; Disease
Newer techniques in primary and final listing 5.05E for We are combining portions of prior
prevention and treatment of bleeding hepatopulmonary syndrome. These listings 5.06 and 5.07 into final listing
gastroesophageal varices, for example, complications are so severe that we 5.06. Ulcerative colitis, Crohn’s disease,
TIPS, banding, sclerotherapy, and laser require only one occurrence of any one granulomatous colitis, and regional
therapy, have significantly improved the of them, shown by the requisite enteritis are now commonly referred to
management of bleeding varices. Based findings, to satisfy the listing. as ‘‘inflammatory bowel disease’’ (IBD).
on these advances, it is no longer • As already noted, we are also In the NPRM, proposed listing 5.06
appropriate to presume disability for 3 adding a new listing 5.05F for hepatic required documentation of IBD with
years as under prior listing 5.05A. encephalopathy. The new listing persistent or recurrent intestinal
Therefore, the final listing (like the requires hepatic encephalopathy obstruction. The proposed listing
proposed listing) provides that we will documented by abnormal behavior, repeated the criteria from prior listing
consider an individual disabled for 1 cognitive dysfunction, changes in 5.07A, clarified that the intestinal
year following the last documented mental status, or altered state of obstruction must be documented by
transfusion. After that, we will evaluate consciousness, present on at least two appropriate medically acceptable
the residual impairment(s). evaluations at least 60 days apart within imaging or operative findings, and
included the requirement for IBD. However, in response to comments FR 20018) based on another NPRM in
documentation of two episodes of regarding individuals who need which we had also proposed to add this
obstruction over a consecutive 6-month parenteral nutrition, we are adding a listing. (See 65 FR 6934.) Therefore, in
period despite prescribed treatment, to new listing, final listing 5.07, for short these final rules, we are retaining the
ensure that there is a chronic bowel syndrome to address situations in listing we published in April 2002,
impairment. which post-operative nutritional needs revising it to include the phrase ‘‘1 year
In response to public comments, we cannot be met orally or with following the date of transplantation,’’
are significantly revising and expanding supplemental enteral nutrition. This and changing the punctuation to make
final listing 5.06. As in the proposed final listing requires a diagnosis of short it easier to read. The only public
listing, the introductory paragraph of bowel syndrome due to surgical comments we received about this listing
final listing 5.06 requires resection of more than one-half of the agreed that we should add it.
documentation of IBD by endoscopy, small intestine with resulting
biopsy, appropriate medically dependence on daily parenteral How are we changing the introductory
acceptable imaging, or operative nutrition via a central venous catheter. text to the listings for evaluating
findings. As in the NPRM, final listing digestive disorders in children?
5.06A requires obstruction of stenotic Listing 5.08—Weight Loss Due to Any
Digestive Disorder 105.00 Digestive System
areas in the small intestine or colon
with proximal dilatation. We are In this final rule, we changed the As in the adult rules, we are revising
clarifying in the final rule that heading of prior and proposed listing the introductory text to the digestive
adhesions do not satisfy the requirement 5.08, ‘‘Weight loss due to any persisting system in part B, final 105.00, to
for obstruction. This is not a substantive gastrointestinal disorder’’ to ‘‘Weight provide additional guidance for
change but a clearer statement of our loss due to any digestive disorder.’’ We adjudicating digestive disorders. Where
intent that there must be obstruction deleted the word ‘‘persisting’’ for necessary, we are adding information
that results from IBD. We are also reasons we explain in the public specific to children; however, we are
clarifying that, in these cases, the comments section of this preamble. repeating much of the introductory text
stenotic areas may be shown by surgery In final listing 5.08, we are of final 5.00 in final 105.00. This is
or by medically acceptable imaging. In establishing the severity of the weight because, for the most part, the same
addition, we are clarifying the language loss based on the CDC’s BMI formula, basic rules for establishing and
we had proposed by requiring rather than the Metropolitan Life evaluating the existence and severity of
hospitalization for treatment of the Insurance Company’s weight charts we digestive disorders in adults also apply
obstruction (intestinal decompression or used in the proposed rules and which to children. We are making a number of
surgery). This is not a substantive were last updated in 1983. When we changes from the NPRM in the final
change from the NPRM because listing- published the NPRM in 2001, we rules to make part B even more
level obstruction of a stenotic area indicated that neither the CDC nor any consistent with part A than we
would require hospitalization for one of other recognized authority known to us originally proposed. As we note below,
these types of treatment. Therefore, the had determined a BMI for adults that we are also adding:
requirement in the final listing will only would be consistent with listing-level • Listing 105.02 for gastrointestinal
help to confirm the existence of listing- severity weight loss. However, since hemorrhaging from any cause requiring
level obstruction caused by IBD. that time, we determined that we could blood transfusion;
We are deleting the proposed establish a BMI comparable to the • Listing 105.05A for hemorrhaging
requirement for persistent or recurrent severity standard in the weight charts. from esophageal, gastric, or ectopic
obstruction over a consecutive 6-month We established this BMI level in the varices, or from portal hypertensive
period despite prescribed treatment in final listing by calculating the BMI for gastropathy;
response to a public comment. Instead, each value on proposed weight tables I • Listings 105.05C, D, and E for
we are requiring that the findings occur and II and averaging them. complications of chronic liver disease;
on at least two distinct occasions at least We are changing to the more widely • Listing 105.05F for hepatic
60 days apart within a consecutive 6- used BMI for several other reasons. For encephalopathy;
month period. example, this change eliminates the • Listing 105.05G for end stage liver
Final listing 5.06B includes six other need for gender tables, as BMI is not disease with SSA CLD and SSA CLD–
manifestations of IBD that were gender-specific in adults. Also, we were P score criteria;
suggested by commenters. Consistent not able to apply the prior and proposed
• Listing 105.05H for extrahepatic
with most of the other criteria in the weight tables to individuals whose
biliary atresia;
final rules for impairments that have height was outside the table values, and
episodic manifestations, final listing instead had to review the evidence and • Listing 105.06 for inflammatory
5.06B requires that two of the six determine whether the impairment bowel disease;
criteria be present on at least two medically equaled the listing. Now we • Listing 105.07 for short bowel
evaluations, occurring at least 60 days can apply the BMI formula to all cases syndrome; and
apart within the same consecutive 6- regardless of the individual’s height. • Listing 105.10 for the need for
month period, except for listing 5.06B6, Also, our use of BMI in this body system supplemental daily enteral feeding via a
which requires supplemental daily is consistent with our use of BMI in gastrostomy.
enteral nutrition via a gastrostomy or Social Security Ruling 02–1p, Title II The following discussions describe
daily parenteral nutrition via a central and XVI: Evaluation of Obesity (67 FR only the significant provisions that are
venous catheter. 57859). unique to the childhood rules or that
require further explanation. We do not
Listing 5.07—Short Bowel Syndrome Listing 5.09—Liver Transplantation
note differences like the fact that we use

As we explained earlier, we are In the NPRM, we proposed to add references to childhood listings instead
removing prior listing 5.07, for regional listing 5.09 for liver transplantation. of adult listings or that we use
enteritis. Instead, we evaluate this However, we published final rules references to ‘‘children’’ instead of
condition under final listing 5.06, for adding this listing on April 24, 2002 (67 adults.
105.00A—What kinds of disorders do guidance for evaluating the expanded reviewed it, we realized that it did not
we consider in the digestive system? listing criteria of final listing 105.06 that provide guidance that would have been
Final 105.00A corresponds to final we provide in part A for final listing useful to the application of final listing
5.00A, except that we are adding 5.06. 105.08 and that it could have been
information to explain that under the confusing for the following reasons:
105.00G—How do we evaluate • As in the NPRM, final listing 105.08
childhood listings we also consider malnutrition in children?
congenital abnormalities involving the includes two criteria for documenting
Final 105.00G (proposed 105.00F1) growth retardation, one for children
organs of the gastrointestinal system.
reflects changes we made to final listing under age 2 (final listing 105.08B1) and
105.00B—What documentation do we 105.08, Malnutrition due to any one for children age 2 and older (final
need? digestive disorder. In final 105.00G1, we listing 105.08B2). Only final listing
The only substantive difference explain that digestive disorders may 105.08B2 includes a criterion for BMI,
between final 105.00B and final 5.00B is result in malnutrition and growth and it refers to the CDC’s latest BMI-for-
a statement noting that we may also retardation. We also explain that we age growth charts or data files. The
need assessments of a child’s growth document the presence of a digestive language we included in proposed
and development. disorder with associated chronic 105.00F1b did not explain this clearly.
nutritional deficiency despite • Furthermore, much of the language
105.00D—How do we evaluate chronic prescribed treatment using the repeated what the listing already said,
liver disease? malnutrition criteria in final listing and we believe that the language that
The new guidance on chronic liver 105.08A. was not redundant of the listing was
disease in final 105.00D generally The malnutrition criteria in final unnecessary. The first sentence defined
corresponds to the information in final listing 105.08A generally correspond to in basic terms how to calculate a BMI;
5.00D in the adult rules, except for the laboratory findings we presented as however, it was oversimplified for
information specific to the examples in the introductory text, children.
complications of chronic liver disease in proposed 105.00F1(a)(1), F1(a)(2), and • The proposed paragraph also
children and two sections (final F1(a)(4). We are including them as referred to the fact that the CDC has
105.00D11b and 105.00D12) that are not listing criteria in final listing 105.08A in determined that a BMI-for-age less than
in part A because they provide guidance response to a public comment. the fifth percentile meets its criteria for
for listing criteria that are only in the Final listing 105.08A1 corresponds to underweight. However, since the CDC
final childhood rules. proposed 105.00F1(a)(1). However, we does not calculate a figure or indicate a
In final 105.00D11b, we provide changed the criterion for anemia to a cutoff that it judges to be indicative of
information about the SSA Chronic hemoglobin of less than 10.0 g/dL, malnutrition, this guidance in the
Liver Disease—Pediatric (SSA CLD–P) rather than less than 8 g/dL, to be proposed rule would not have been
calculation, which we use under final consistent with the anemia criteria useful for applying final listing 105.08.
listing 105.05G2 for children who have elsewhere in these final listings. Final In final 105.00G2, which replaces
not attained age 12. We explain in final listing 105.08A2 requires low serum proposed 105.00F1b, we are providing
105.00D11b(iv) that we will not albumin levels and corresponds to information that is more relevant to the
purchase the INR value required to proposed 105.00F1(a)(2). Final listing application of final listing 105.08B. We
calculate the SSA CLD–P score because 105.08A3 corresponds to proposed explain that we use the most recent
obtaining the necessary amount of blood 105.00F1(a)(4), except that we added the growth charts published by the CDC. In
to perform this test in small children phrase ‘‘fat soluble’’ to clarify the type final 105.00G2a, we explain that we use
often requires an invasive procedure. of vitamin deficiency we intended. We the CDC’s age- and gender-specific
We further explain that if we do not also removed the concluding phrase weight-for-length charts for children
have an INR value for a child under 12 ‘‘despite aggressive medical and who have not attained age 2. In final
within the applicable time period, we nutritional therapy’’ because the 105.00G2b, we explain that we use the
will use an INR value of 1.1 for the SSA introductory paragraph of the listing CDC’s gender-specific BMI-for-age
CLD–P calculation. (In final requires findings ‘‘despite continuing charts for children age 2 or older. In
105.00D11a, we provide the same treatment as prescribed.’’ We did not final 105.00G2c, we explain how we
guidelines about the SSA CLD include as a listing criterion the calculate BMI, and in final 105.00G2d
calculation as we do in part A because example of intractable steatorrhea we provide the corresponding BMI
the SSA CLD calculation is applicable to (malabsorption of dietary fats) formulas. Final 105.00G2c and
children age 12 to the attainment of age quantified by fecal fat excretion that we 105.00G2d are the same as final 5.00G2a
18.) had included in proposed and 5.00G2b.
In final 105.00D12, we provide 105.00F1(a)(3); most pediatric
105.00H—How do we evaluate the need
guidance for applying final listing laboratories no longer do this type of
for supplemental daily enteral feedings
105.05H for extrahepatic biliary atresia, testing, and steatorrhea will usually
via a gastrostomy?
a congenital disorder of the liver. result in the vitamin deficiency we
describe in final listing 105.08A3. Final 105.00H is a new section that
105.00E—How do we evaluate In 105.00F1b of the proposed rules, provides guidance for evaluating the
inflammatory bowel disease (IBD)? we included a paragraph discussing need for feeding gastrostomies for
Final 105.00E corresponds to final Body Mass Index (BMI) measurements. children under age 3 under final listing
5.00E. In the NPRM, we proposed a We explained in the preamble of the 105.10. We had previously provided for
short section (proposed 105.00F4) on NPRM that we proposed to add this a finding of functional equivalence for
IBD that provided guidance for discussion because proposed listing children under age 3 who require a
evaluating IBD under proposed listing 105.08 included criteria based on BMI gastrostomy for feeding in
105.06. As in final listing 5.06 in part A, measurements. (See 66 FR at 57015 and § 416.926a(m)(10). We are now making
we have greatly expanded proposed 57020.) that example of functional equivalence
listing 105.06 in these final rules, so we We are not including this paragraph a listing and removing the example from
are also including the more detailed in the final rules because, when we § 416.926a(m).
105.00I—How do we evaluate cited in our discussion of prior listing extrahepatic biliary atresia, as diagnosed
esophageal stricture or stenosis? 5.05E (final listing 5.05F) above, we are on liver biopsy or intraoperative
Final 105.00I corresponds to proposed including criteria for evaluating hepatic cholangiogram. We will consider
105.00F3 and includes minor editorial encephalopathy in the digestive listings, children who meet this requirement to
changes for clarity. In this section, we final listing 105.05F, instead of be disabled for 1 year following the
evaluating this impairment under the diagnosis, and we will evaluate residual
provide guidance for evaluating
criteria for organic mental disorders. We liver function after that period.
esophageal stricture or stenosis, which
we had listed in prior listing 105.03, a will also evaluate the impairment in Listing 105.06—Inflammatory Bowel
listing we are removing because it is a prior listing 105.05D, hepatic coma, Disease (IBD)
reference listing. In the final rule, we under final listing 105.05F.
The following is a detailed We are redesignating prior listing
explain that these conditions may be 105.07, chronic inflammatory bowel
explanation of the changed listing
evaluated under listing 105.08 or disease, as final listing 105.06 for
criteria where they differ from the part
105.10. We also provide guidance for consistency with the corresponding
A listings.
adjudicating these conditions when they adult listing. Final listing 105.06 is the
do not meet a listing but the child still Listing 105.02—Gastrointestinal same as final listing 5.06, except that it
has problems maintaining nutritional Hemorrhaging From Any Cause, does not include a criterion for weight
status. Requiring Blood Transfusion loss from baseline. This criterion is
105.00K—How do we evaluate Final listing 105.02, which inappropriate for children because they
impairments that do not meet one of the corresponds to final listing 5.02, was not are continually growing, and therefore
digestive disorder listings? in the NPRM. We are adding it in do not have a ‘‘baseline weight.’’ (We
response to a public comment described can evaluate weight loss, inadequate
Final 105.00K corresponds to final later in this preamble. The final listing growth, and malnutrition secondary to
5.00I, except that we include two is the same as final listing 5.02, except IBD under final listing 105.08.)
additional examples of digestive for the amount of blood transfused. In Proposed listing 105.06B required IBD
impairments relevant to children that final listing 105.02, we provide a ratio with perineal or intra-abdominal
we would evaluate in other body of volume of blood to the child’s weight, complications, such as abscess, fistulae,
systems. These are the same additional which is a more medically appropriate or fecal incontinence. These
examples we included in proposed standard for children. complications must have been
105.00E1; however, we made minor intractable despite medical or surgical
editorial changes to these examples for Listing 105.05—Chronic Liver Disease treatment, and clinically documented
clarity. Final listing 105.05A replaces prior over a 6-month period. Final listing
How are we changing the listings for listing 105.05C, chronic liver disease 105.06 includes a criterion for perineal
evaluating digestive disorders in with esophageal varices. The final disease with draining abscess or fistula.
children? listing is the same as final listing 5.05A, However, we did not include fecal
except for the amount of blood incontinence because final listing
105.01 Category of Impairments, transfused. As in final listing 105.02, we 105.06 includes a much wider array of
Digestive System provide a ratio of volume of blood to the complications resulting from IBD and
Removal of Redundant or Reference child’s weight, which is a more children with listing-level impairments
Listings medically appropriate standard for who have fecal incontinence would be
children. evaluated under criteria in final listing
As in the adult listings, we are Final listings 105.05C, D, E, F, and G 105.06.
removing the following reference correspond to final listings 5.05C, D, E,
listings and other listings that are no F, and G in part A, with appropriate Listing 105.07—Short Bowel Syndrome
longer appropriate: changes to reflect findings and (SBS)
• 105.03—Esophageal obstruction, laboratory values for children. Also, This new listing is the same as final
caused by atresia, stricture or stenosis, final listing 105.05G includes both an listing 5.07 except that it applies to
which referred to listing 105.08; SSA CLD score criterion for children age children. It eliminates the need for a
• 105.05F—Chronic liver disease 12 and older (final listing 105.05G1) and finding of functional equivalence for
with chronic active inflammation or an SSA CLD–P score criterion for children of any age who have a frequent
necrosis documented by SGOT children who have not attained age 12 need for a central venous alimentation
persistently more than 100 units or (final listing 105.05G2). catheter, as we described in the example
serum total bilirubin of 2.5 mg percent We provide that an SSA CLD–P score of functional equivalence in prior
or greater; of 11 or greater meets the listing. We § 416.926a(m)(3).
• 105.07B—Chronic inflammatory chose this score based on the clinical
bowel disease with malnutrition, which Listing 105.08—Malnutrition Due to Any
severity represented by the values
referred to listing 105.08; and Digestive Disorder
contained in the SSA CLD–P score,
• 105.07C—Chronic inflammatory which we believe represents the degree Final listing 105.08 corresponds to
bowel disease, with growth impairment of severity consistent with listing level proposed listing 105.08; however, as we
as described under the criteria in severity. have already noted, we are including as
100.03. However, we are adding For final listing 105.05G2, we require listing criteria three of the examples of
material to the introductory text in final two calculations of SSA CLD–P scores, laboratory findings that would confirm
105.00G2 to address the assessment of at least 60 days apart, and the scores chronic nutritional deficiency we had
growth retardation that is secondary to must be calculated within a consecutive included in proposed 105.00F1a. We
any digestive disorder. 6-month period, consistent with other also removed the statement from
Prior listing 105.05E, for hepatic provisions in these final rules. proposed listings 105.08A and B that
encephalopathy, was a reference listing, Final listing 105.05H replaces prior the required findings are ‘‘expected to
referring to listing 112.02 for organic listing 105.05A, inoperable biliary persist for at least 12 months,’’ because
mental disorders. For the reasons we atresia. The new listing requires it is unnecessary. Under our general
rules for evaluating disability, an Conforming Changes different from the way we designate
impairment must meet the duration paragraphs in our other body system
Listing 6.02—Impairment of Renal
requirement. listings. We changed those designations
Function
Final listing 105.08 is consistent with so they are in the same format as our
the weight-for-length and BMI-for-age For the reasons discussed in the other listings sections. None of these
charts and data file tables from the CDC. explanation of changes for listing 5.08, changes are substantive.
According to the CDC, these are the Weight loss due to any digestive
disorder, we are also revising listing Public Comments
recommended measurements to
determine if an individual’s weight is 6.02C4 to use BMI. We are also In the NPRM we published in the
appropriate for his or her height. On removing the criterion for ‘‘recent’’ Federal Register on November 14, 2001
May 30, 2000, the CDC updated its 1977 weight loss and replacing it with the (66 FR at 57009), we provided the
weight-for-length growth charts, and same criterion we use in the final public with a 60-day comment period.
introduced BMI-for-age charts and digestive disorder listings, a The comment period ended on January
tables.1 The CDC explained that: requirement for two measurements at 14, 2002. In response to that NPRM, we
least 60 days apart within a 6-month received letters, telefaxes, and e-mails
These BMI-for-age charts were created for
use in place of the 1977 weight-for-stature
period. from 11 commenters containing
charts. BMI * * * is used to judge whether comments pertaining to the changes we
Section 416.924b—Age as a Factor of
an individual’s weight is appropriate for their proposed. The commenters included
Evaluation in the Sequential Evaluation
height. * * * The new BMI growth charts can physicians, advocates for individuals
Process for Children
be used clinically beginning at 2 years of age, who have disabilities, individuals who
when an accurate stature can be obtained. We are correcting the reference in the have digestive disorders, and State
last sentence of § 416.924b(b)(3), which agencies that make disability
As we have already noted, the CDC
should refer to the functional determinations for us.
also defines ‘‘underweight’’ in children
equivalence examples in On November 8, 2004, we published
as a BMI-for-age less than the fifth
§ 416.926a(m)(7) or (8) but incorrectly a limited reopening of the comment
percentile, but neither the CDC nor any
designates this functional equivalence period of the NPRM in the Federal
other recognized expert authority has
rule as § 416.924a rather than Register (69 FR 64702) to request
published guidelines for the
§ 416.926a. Also, because we are additional comments about our
classification of malnutrition based on
removing two of the examples of proposals to revise and remove chronic
BMI. Therefore, we will continue to
functional equivalence, liver disease listings. We published this
monitor this area, and in the meantime, §§ 416.926a(m)(3) and (10), and limited reopening of the comment
continue to use our criterion of redesignating the remaining examples as period because we believed those
persistence of weight below the third explained below, we are revising the proposals were significant. The
percentile to show listing-level severity reference to refer to final comment period also lasted 60 days and
based on malnutrition for children § 416.926a(m)(6) or (7). ended on January 7, 2005. In response
under 2 years of age. The third
Section 416.926a—Functional to this reopening, we received letters,
percentile is generally accepted as the
Equivalence for Children telefaxes, and e-mails from 539
lower limit of the normal range for most
commenters pertaining to the changes
biologic measurements, and persistence We are removing paragraph (m)(3), we proposed regarding chronic liver
below this level would warrant the example of functional equivalence disease. The commenters included
evaluation and intervention. Likewise, based on a frequent need for a life- physicians, advocates for individuals
since the current BMI-for-age charts sustaining device at home or elsewhere, who have chronic liver disease,
provide percentiles, we will continue to because we are including the need for individuals who have chronic liver
use measurements below the third a central venous alimentation catheter disease, and State agencies that make
percentile as the listing-level criterion as final listing 105.07 and because we disability determinations for us.
for children age 2 and older. now no longer need this functional In addition, on November 17, 2004,
In response to a comment, we revised equivalence example. during the reopened comment period,
proposed listing 105.08B to indicate that We are also removing paragraph we held an outreach meeting in
we use the latest editions of the CDC’s (m)(10), the functional equivalence Cambridge, Massachusetts. At the
charts, which will ensure that the listing example of gastrostomy in a child who outreach meeting, physicians, advocates
remains current if the CDC revises its has not attained age 3, as it is now final for individuals with liver disorders, and
charts in the future. listing 105.10. individuals who have liver disorders
Listing 105.10—Need for Supplemental Other Changes provided additional comments about
Daily Enteral Feeding via a Gastrostomy We made many editorial changes from chronic liver disease which we included
In response to a public comment, we the NPRM for clarity in these final rules. in the rulemaking record for these final
are adding final listing 105.10 for the For example, we: rules.
• Revised many sentences to put We carefully considered all of the
need for a feeding gastrostomy. Because
them into active voice, to simplify them, written comments in response to the
of this new listing, we no longer need
and to use more consistent style two Federal Register documents and the
the functional equivalence example in
throughout the final rules; comments we received at the outreach
prior § 416.926a(m)(10) for a
• Reorganized some paragraphs into a meeting. Because some of them were
gastrostomy in a child who has not
more logical order; long and many comments were similar,
attained age 3. We are also clarifying
• Clarified several headings; we have condensed, summarized, and
that the gastrostomy must be used for
supplemental enteral feeds on a daily • Eliminated some redundancy from paraphrased them below. We have tried
the proposed provisions; and to present all views adequately and to

basis.
• Revised language for greater respond to all of the issues raised by the
1Centers for Disease Control and Prevention, consistency between part A and part B. commenters that were within the scope
National Center for Health Statistics. CDC growth Also, many of the paragraph of these rules. We provide our reasons
charts: United States. May 30, 2000. designations in the NPRM were for adopting or not adopting the
recommendations in the summaries of the adjudication of significant numbers system listings. Also, our adjudicators
the comments and our responses below. of cases with documented impairments are well aware that they are required to
of the digestive system until there was consult the information in the
Proposed 5.00A and 105.00A—What
6 months of evidence, even when it was introductory text when they apply the
kinds of disorders do we consider in the
obvious that those disorders were not of listings. We will also provide training
digestive system?
listing-level severity. These commenters for our adjudicators on these rules.
Comment: A commenter who has a believed that many digestive disorder It may be possible that administrative
colostomy asked us to include cases could be fairly evaluated after 3 law judges (ALJs) will need to consult
colostomies in our listings. He described months of treatment and that we could with medical experts somewhat more
the problems he had been having with give adjudicators more room for frequently than they did under the prior
his colostomy. judgment. One commenter also listings, but we do not believe that there
Response: We did not adopt the suggested that we combine a will be a large increase in this need. We
comment. Although we agree with the requirement for 3 months of treatment expect that most cases that would have
commenter that some people who have with the establishment of a ‘‘medical met prior digestive disorder listings and
colostomies are unable to work, we did improvement expected’’ diary in that will not meet any of the final
not add a listing for this because the appropriate cases, in order to reflect listings will require an individualized
vast majority of people who have advances in medical treatment and the residual functional capacity assessment
colostomies do not experience long-term fact that some individuals will respond and will not require such expert
complications that would meet the 12- to treatment. medical input to determine whether the
month duration requirement and they Many commenters noted that there individual’s impairment medically
are able to work. However, we did are some conditions that are irreversible equals a listing.
include a statement in final 5.00E4 or progressive and would not require a Comment: Another commenter noted
indicating that if an individual is not 6-month observation period since the that, while many homeless individuals
able to maintain nutrition due to likelihood of substantial improvement infected with hepatitis C virus (HCV) do
surgical diversions of the intestinal with these conditions is negligible. not have medical records that reflect a
tract, including ileostomy and Response: In response to these complete longitudinal history of
colostomy, we will evaluate the comments, we reorganized proposed medical treatment, they may have some
impairment under listing 5.08. 5.00B1 and 105.00B1 and removed the medical evidence. The commenter said
Proposed 5.00B and 105.00B—What sentence stating that we usually need that we should contact the treating
documentation do we need? evidence covering a 6-month period of physicians instead of purchasing
observations and treatment. We did not consultative examinations. The
Comment: Several commenters mean to imply that we would require commenter expressed the view that a
expressed concerns about our statement evidence of 6 months of observation and consultative examiner may not be
in the first sentence of proposed 5.00B1 treatment for all cases involving familiar with treating people with HCV,
and 105.00B1 that we usually need digestive disorders. We agree with the especially those who are homeless. The
longitudinal evidence covering a period commenters that some digestive commenter indicated that SSA could
of at least 6 months of observations and disorders are irreversible and save financial resources and secure
treatment, unless we can make a fully progressive and could be fairly better evidence for use in evaluations if
favorable decision without it. One evaluated after 3 months of treatment, or all community medical sources were
commenter was concerned that the even less. For example, final listing 5.02 contacted.
proposed requirement was overly does not require 6 months of evidence Response: We make every reasonable
burdensome, especially for low-income if the 3 required hemorrhages and effort to secure evidence from
claimants and the homeless who are transfusions occur in less than a 6- individuals’ treating physicians and
unable to access health care. This month period, as long as the other medical sources. Sections
commenter noted that proposed 5.00B2 transfusions are at least 30 days apart; 404.1512 and 416.912 of our regulations
(incorrectly designated as 5.00B3 in the and listing 5.05A requires only one require us to make every reasonable
NPRM) provided guidance for episode of bleeding varices that require effort to obtain a complete medical
considering medical equivalence when blood transfusion. In response to history from an individual’s medical
an impairment did not meet a listing, comments, we also added three new sources. However, the regulations also
but was concerned that adjudicators listings for chronic liver disease (final explain that we will order a consultative
might overlook that guidance because it listings 5.05C, D, and E) that can be examination if the information we need
was in a separate paragraph. The satisfied with documentation of the is not readily available from the records
commenter was also concerned that required findings on only one occasion. of the individual’s medical sources or if
administrative law judges would need We recognize that some individuals we are unable to obtain clarification
more testimony from medical experts to may not have access to ongoing from the medical sources.
consider the issue of medical treatment and that, because of this, they
equivalence. The commenter asked us to may not be able to demonstrate that Proposed 5.00C and 105.00C—How do
provide more alternatives for claimants their impairments meet the criteria of we evaluate digestive disorders under
who, through no fault of their own, are listings in this body system. As we listings that require persistent or
unable to access continuous health care explain in final 5.00C6 and 105.00C6, it recurrent findings?
treatment. may be necessary to determine whether Comment: One commenter stated that
Some commenters stated that an individual’s impairment or our requirement that a ‘‘recurrent’’ or
adjudicators may consider the 6-month impairments medically equal a listing or ‘‘persistent’’ finding must have lasted or
requirement for observation and are disabling based on consideration of be expected to last for 12 months is
treatment absolute and not read the residual functional capacity. We do not medically inappropriate for
introductory text in proposed sections believe that adjudicators will overlook decompensated cirrhosis because
5.00B3 and 105.00B2. The commenters this guidance in the introductory text continued deterioration is expected. The
believed that the proposed provision because it reflects general adjudicative commenter also indicated that three
would require our adjudicators to defer policy that applies to all the body events within a 6-month period with 1
month between events is medically B and C virus. We explain that administration of such nutrition, and
inconsistent with the natural history of treatment for chronic viral hepatitis potential related complications. Many
chronic liver disease because the infections will vary considerably due to individuals who receive home
disease is chronic and, therefore, a child’s age, medication tolerance, parenteral or supplemental enteral
progressive. The commenter treatment response, and duration of the nutrition have a reasonably normal
acknowledged that some individuals treatment. While we do not include the lifestyle, including regular employment.
with chronic liver disease experience specific example of effects on Therefore, we do not think it
episodes of symptoms and signs, but ‘‘development’’ recommended by the appropriate to presume disability in all
said that we should not have episodic first commenter, we do include a individuals who need such treatment;
requirements alone for the evaluation of number of other examples of more we must evaluate most situations on a
the condition. common adverse effects of treatment in case-by-case basis. However, we did
Response: We agree with the children. agree that in certain instances the need
commenter that we do not need In addition, we have other rules for for parenteral nutrition can be disabling.
episodic requirements or evidence of evaluating disability in children, and Therefore, we added final listings 5.07
persistence for all cases involving these rules address the kinds of issues and 105.07 for short bowel syndrome
chronic liver disease. Based on this and raised by both commenters. In when post-operative nutritional needs
other comments, we removed proposed § 416.924a(b)(9) of our regulations, we cannot be met orally and an individual
5.00C and 105.00C and added final include a detailed explanation of how requires daily parenteral nutrition via a
listings 5.05C through 5.05G. By making we consider the effects of treatment in central venous catheter. We also added
these changes, we provide additional children. This section explains that we a criterion based on the need for daily
criteria that are appropriate for consider, among other things, any enteral nutrition via a gastrostomy or
evaluating the impairments of functional limitations that are caused by daily parenteral nutrition via a central
individuals who have progressive, the side effects of treatment and the venous catheter in final listings 5.06 and
chronic liver disease. Final listings frequency of the need for treatment; in 105.06 for IBD.
5.05A, 5.05C, 5.05D, and 5.05E provide the latter case, we explain that frequent As a consequence of the changes we
for a determination of disability based therapy may interfere with a child’s made in response to this comment, we
on findings on a single occasion. On the participation in typical daily activities, are also removing two of the examples
other hand, final listings 5.05B, 5.05F, which implicitly can also affect of functional equivalence in
5.05G, and 5.08 include conditions that development. Likewise, in § 416.926a § 416.926a(m). Section 416.926a(m)(3)
may be acute or chronic and that may we include additional guidance provided for a finding of functional
respond to treatment. They contain explaining that we consider limitations equivalence for children of any age who
requirements for episodes of symptoms that result from treatment when we have a frequent need for a life-
and signs. make determinations about functional sustaining device, ‘‘e.g., central venous
equivalence (see § 416.926a(a)). In the alimentation catheter.’’ Section
Proposed 5.00D and 105.00D (final
sixth domain of functioning, ‘‘health 416.926a(m)(10) provided for a finding
5.00C and 105.00C)—How do we
and physical well-being,’’ we consider of functional equivalence for children
consider the effects of treatment?
the cumulative physical effects of who have not attained age 3 and who
Comment: One commenter suggested physical or mental impairments and have a gastrostomy. Therefore, in these
that we discuss how the side effects of their associated treatments or therapies final rules, we are removing functional
medication can affect a child’s growth on a child’s functioning (see equivalence examples (m)(3) and
and social development. Another § 416.926a(1). We also explain that (m)(10) because we no longer need
commenter noted that treatment side medications and other treatments a them, as we explained earlier in this
effects can be debilitating and can cause child receives may have physical effects preamble.
functional limitations that validate that also limit his or her performance of If we determine that the impairment
disability. The commenter activities (see § 416.926a(a)(3)). does not meet or medically equal one of
recommended that we expand our Comment: One commenter disagreed these listings, we will consider the need
system of disability evaluation to with the proposed guidance on for parenteral or supplemental enteral
acknowledge and articulate how parenteral and specialized enteral nutrition via a gastrostomy in our
treatment can affect a child’s physical, nutrition. The commenter stated that residual functional capacity assessment
emotional, and social development, individuals who have intravenous or or functional equivalence
including specifying how these factors gastrostomy tubes require special determination, especially in the kinds of
(including school performance) should equipment and frequently require situations described by the commenter.
be evaluated. This commenter said that multiple feedings a day that may entail For example, the functional equivalence
we should integrate all aspects of a significant amount of time. In the domain for children called ‘‘health and
functional development into the commenter’s opinion, this is so physical well-being’’ requires us to
evaluation criteria. intrusive that individuals who require consider the cumulative physical effects
Response: We did not adopt these parenteral or specialized enteral of physical or mental impairments and
comments because we believe that these nutrition to avoid debilitating their associated treatments or therapies
final rules and our other rules complications of a disease should be on the child’s functioning (see
sufficiently address issues of considered not able to work, and § 416.926a(l)).
developmental delay and other disability should be established if the
potentially adverse effects of treatment. 12-month duration requirement has Proposed 5.00F and 105.00F—What are
These final rules include general been, or is expected to be, met. our guidelines for evaluating specific
guidance to our adjudicators in final Response: We partially adopted the digestive disorders? (Final 5.00D and
105.00D—How do we evaluate chronic
105.00C about assessing any adverse comment. There is a wide range in the
effects of treatment. Final 105.00D4 nature and severity of underlying liver disease?)
includes a detailed discussion of the diseases that require parenteral or Comment: Several organizations made
effects of treatment for chronic viral supplemental enteral nutrition, the type suggestions for specific language
hepatitis infections, including hepatitis of delivery and scheduling of changes to the introductory text of the
listings (proposed 5.00 and 105.00). law to reevaluate the disability status of ‘‘moderate to severe,’’ because these
Many commenters asked us to expand all individuals who qualify for disability terms are subject to varying
our discussion of the signs, symptoms, benefits and this applies even to people interpretations and their use would not
and complications of chronic liver who have permanent impairments. promote consistent adjudication.
disease. They asked us to list symptoms, Therefore, there would be no practical Comment: One commenter suggested
such as chronic fatigue, chronic reason for us to add the phrase that we provide detailed information
indigestion, diarrhea, constipation, and requested by the commenter. about a number of extrahepatic
sleep disturbances. Commenters also Comment: One commenter manifestations and complications of
proposed that we add specific recommended that we delete the word chronic liver disease and suggested
laboratory findings to the introductory ‘‘function’’ in proposed 5.00F2d and additional language for proposed 5.00F
text, such as decreased platelets and 105.00F2e when referring to liver tests (final 5.00D).
acid-base imbalances. They suggested because liver enzymes are not liver Response: Based on this and other
that we should take into account the function tests. comments, we added language in final
frequency of extrahepatic manifestations Response: We adopted the comment 5.00D7 through D11 and the
resulting from chronic liver disease and in final 5.00D3c and 105.00D3c. corresponding paragraphs in 105.00.
factor them into the medical evaluation. Comment: One commenter suggested These sections provide guidance
Response: We partially adopted these we delete the word ‘‘minimal’’ when relevant to the application of the new
comments by expanding the referring to ascites in proposed listings we are adding for complications
introductory text to provide additional 5.00F2(d) and 105.00F2(e) (final 5.00D6 of chronic liver disease; that is, final
adjudicative guidance on symptoms and and 105.00D6) and that we change it to listings 5.05C through G and 105.05C
signs of chronic liver disease. We are ‘‘small volume.’’ The commenter also through H. We also provide information
providing general information on suggested that we delete ‘‘and not on on extrahepatic manifestations of
symptoms and signs in final 5.00D3 and physical examination’’ in this same hepatitis B and C in final 5.05D4d and
105.00D3, and, where appropriate, section to more clearly indicate that we 105.05D4d. The additional information
specific information about symptoms are referring to incidental and clinically we provide is relevant only to
and signs of particular chronic liver insignificant findings of ascites found application of the listings, and therefore,
diseases. For example, in final on imaging studies alone. does not include the amount of detail
5.00D4c(ii) and 105.00D4c(ii), we Another commenter indicated that this commenter suggested.
provide examples of symptoms ascites should be evident on physical Comment: Several commenters
associated with the adverse effects of examination and not identified solely by requested that we provide a listing for
treatment for chronic hepatitis C virus an imaging procedure that might show individuals placed on a liver transplant
infection, and in final 5.00D4d and clinically insignificant findings of list. They submitted proposals for the
105.00D4d, we also provide examples of ascites. This commenter also suggested introductory text to explain this
extrahepatic manifestations of chronic listing criteria based on intractable suggested listing.
viral hepatitis by body system. We did ascites, documented on physical Response: We did not adopt the
not adopt all the specific language examination as moderate to severe, or suggestion of placement on a liver
commenters requested because certain hydrothorax, poorly controlled by or transplant list alone as a listing because
symptoms, such as indigestion, unresponsive to diuretic treatment, or the threshold criteria for placement on
diarrhea, and constipation, are generally requiring paracenteses for control. a transplant list vary widely throughout
not features of chronic liver disease. Response: We agree with the the country and because individuals
However, we did include in final commenters that current imaging may be placed on a list well before they
5.00D3c and 105.00D3c decreased techniques are capable of detecting even have listing-level impairments.
platelet count in the list of laboratory minimal amounts of ascites before However, based on this and other
findings associated with chronic liver detection may be possible on physical comments we added final listings 5.05G
disease, and we indirectly referenced examination. However, the criteria of and 105.05G for end stage liver disease
acid-base imbalances by adding proposed listings 5.05B2 and 105.05B2 documented by particular scores
increased ammonia levels as another did not base severity solely on the determined using the SSA Chronic Liver
laboratory finding. presence of ascites detected by physical Disease (SSA CLD) calculation and SSA
Comment: One commenter suggested examination or by imaging studies; nor Chronic Liver Disease-Pediatric (SSA
that we add the phrase ‘‘or the do these final listings. To meet the CLD–P) calculation. We based these
remainder of an individual’s natural severity requirement, the laboratory calculations on the Model for End Stage
life’’ to the first sentence of proposed findings in final 5.05B2 and 105.05B2 Liver Disease and the Pediatric End
5.00F2 (final 5.00D1). This sentence must also be present. If the laboratory Stage Liver Disease (MELD and PELD)
described chronic liver disease and findings are at the level specified in the scales that were developed by the
explained that it persists for more than listing, it is not necessary to quantify the United Network of Organ Sharing for
6 months and is expected to continue ascites because there will be sufficient prioritizing patients waiting for liver
for at least 12 months. information to show that the individual transplants based on statistical formulas
Response: We did not adopt the is disabled. Therefore, we did not adopt for predicting mortality from liver
comment. The issue in our initial the comment to change the quantifier disease.
disability determinations and decisions from ‘‘minimal’’ to ‘‘small volume’’ Comment: One commenter noted that
under the listings is whether the ascites; instead, we removed it. liver patients regularly have laboratory
individual has an impairment that We adopted the second commenter’s studies to track their liver function. Any
prevents him or her from engaging in suggestion to include criteria in final decline in function is evident almost
any gainful activity (or in a child, that listing 5.05B and 105.05B for immediately and these laboratory
causes ‘‘marked and severe functional hydrothorax because ascitic fluid can studies are often done bi-weekly, or
limitations’’) and that has lasted or can collect in the chest cavity and result in weekly in some cases. The commenter
be expected to last for a continuous a very serious impairment. We did not said that we should be able to use the
period of 12 months or that is expected adopt the other recommendation that laboratory findings rather than wait
to result in death. We are required by we characterize listing-level ascites as until a patient’s condition declines to
the point that he or she needs a liver Response: We clarified the expressed concern about ‘‘compressing’’
transplant. requirements by deleting the sentence in prior listings 5.05 B, C, D, E, and F into
Response: We partially adopted the proposed listing 5.02 that referred to proposed listing 5.05B, which contained
comment. Although we have indicated episodes within a 14-day period because only two sets of severity criteria. Some
that laboratory studies may not be a it could have been confusing and was commenters said that the proposed
good indicator of disability, since there not necessary for correctly applying the listings were vague and too narrow in
may be a poor correlation between the listing. Although our intent was to scope. Commenters believed that this
studies and the severity of liver disease, explain that several bleeds may occur would make our determinations more
we believe that some laboratory findings during a single episode, listing-level restrictive and perhaps erroneous. They
can be indicative of listing-level severity severity is based on hemorrhages that urged us to expand the medical
for certain disorders, such as require transfusions and not the actual evaluation criteria to more accurately
spontaneous bacterial peritonitis (final number of bleeds per episode. We reflect the pathophysiology of chronic
listings 5.05C and 105.05C), hepatorenal require 30 days between hemorrhages liver disease. The commenters believed
syndrome (final listings 5.05D and that require transfusion in order to that the listings should be more specific
105.05D), hepatopulmonary syndrome establish that there are separate events and inclusive with regard to signs,
(final listings 5.05E and 105.05E), and and that the condition is chronic. symptoms, complications, treatment,
end stage liver disease (final listings and metabolic and functional factors to
Final Listings 5.05 and 105.05—Chronic
5.05G and 105.05G). make the evaluation of chronic liver
Liver Disease
disease more on par with HIV criteria
Final Listing 5.02—Gastrointestinal Comment: One commenter because hepatitis C is a systemic illness
Hemorrhage From Any Cause, Requiring recommended that we place the study that encompasses a broad spectrum of
Blood Transfusion ‘‘endoscopy’’ before ‘‘x-ray’’ in listing diseases similar to HIV infection.
Comment: Proposed listing 5.02 5.05A because 95 percent of diagnoses Response: We adopted many of these
specified that at least 2 units of blood for varices are made by endoscopy. comments. We significantly expanded
must be transfused per episode. One Response: We adopted the comment. the listing criteria for chronic liver
Comment: We received many disease. For example, we expanded
commenter expressed concern that
comments asking us to change the proposed listings 5.05A and 105.05A to
different physicians and different
headings of listings 5.05 and 105.05. include hemorrhaging from gastric or
religious preferences can dictate when
Commenters suggested eliminating the ectopic varices and portal hypertensive
and how much blood is transfused. The
words ‘‘and cirrhosis of any kind,’’ gastropathy. We also expanded
commenter said that it appeared more
stating that ‘‘cirrhosis’’ is chronic liver proposed listings 5.05B and 105.05B to
reasonable to use hematocrit levels,
disease. Commenters also pointed out include hydrothorax as well as ascites.
which are standardized, instead of a
that individuals may have chronic liver We added four listings in parts A and
more subjective and less standardized
disease but not necessarily cirrhosis. B based on suggestions from
method based on the number of units Response: We adopted the comments
transfused. commenters: Final listings 5.05C, D, E,
and removed the reference to and G, and 105.05C, D, E, and G. We
Response: We did not adopt the ‘‘cirrhosis’’ from the headings of the two also replaced the prior reference listing
comment to use a hematocrit level in listings. for hepatic encephalopathy with a
this listing because it takes time for the Comment: One commenter stated that stand-alone listing for this complication
hematocrit to equilibrate following the definition of cirrhosis can be of chronic liver disease (final listings
rapid blood loss. We also did not adopt subjective. The commenter said that one 5.05F and 105.05F).
the comment to remove the 2-unit doctor who reads a tissue sample may Analogous to the detailed guidance
requirement for the amount of blood diagnose fibrosis and another doctor we provide about HIV infection in
transfused per episode in final listing may diagnosis cirrhosis. This 14.00D and 114.00D of our listings, we
5.02. As we explained earlier, we chose commenter stated he had had have greatly expanded the introductory
2 units of blood because this is the debilitating symptoms before he text to include detailed information on
minimum amount of blood that is officially had cirrhosis. chronic viral hepatitis infections in final
usually transfused. Response: We do not agree that the 5.00D4 and 105.00D4. We provide
We recognize that there are definition of cirrhosis is subjective. information about the symptoms, signs,
individuals who may object to Cirrhosis is a disorder defined by and complications of chronic hepatitis B
transfusions. In such cases, their pathology. Fibrosis is an early form of and C virus, and include information
impairments cannot meet the scarring. Cirrhosis is late-stage disease about the types of treatment for these
requirements of any listing that includes and readily distinguishable by infections and the common adverse
a criterion for a transfusion. However, it pathologists from fibrosis. We do agree, effects of this treatment. We have also
is certainly possible for a person who however, that individuals can have added information on extrahepatic
refuses transfusions to be found debilitating problems from chronic liver manifestations of hepatitis B and C virus
disabled under our other rules for disease before they develop cirrhosis. by body systems.
determining disability. As we have noted in a number of places We did not add all of the suggested
Comment: One commenter noted that throughout this preamble, we have complications or extrahepatic
in proposed listing 5.02 we stated that expanded and clarified the final rules to manifestations of chronic liver disease
all incidents within a consecutive 14- ensure that we identify people without because most respond to prescribed
day period constitute one episode, but cirrhosis who should qualify under treatment and they are generally very
in proposed 5.00C2 we also stated that these final listings. rare. Also, some of the suggested
there must be at least 1 month between Comment: Many commenters noted extrahepatic syndromes are multi-
events (incidents). The commenter that the proposed changes for chronic causal, may be unrelated to the liver
asked us to clarify these requirements liver disease contained fewer criteria disease, and poorly correlate with the
because it seemed that all events within (physical examination, laboratory, or degree of liver destruction. Very serious
a 30-day period should constitute one imaging tests) to establish disability extrahepatic manifestations that we did
episode. than did the prior listings. They not list in these final rules can be
evaluated under the affected body to the NPRM, more modern types of introductory text for using the new
system. Lesser manifestations are procedures, such as TIPS, are less risky listings.
evaluated in the residual functional and can be performed before the Comment: We received many
capacity assessments or functional condition becomes serious enough to comments regarding the use of liver
equivalence evaluations later in the meet the level of severity required by biopsies in the evaluation of chronic
appropriate sequential evaluation our listings. Therefore, we cannot liver disease. Commenters stated that
process for adults or children. (We presume that everyone who has had a individuals with chronic liver disease
describe the sequential evaluation TIPS procedure is disabled. However, may suffer from a multitude of
process later in this preamble.) we will evaluate the severity of the symptoms and have little evidence of
Comment: Several commenters underlying chronic liver disease under injury to their liver, while others may
suggested we include a classification final listing 5.05, and if it does not have few symptoms, even with
system, such as the Child-Turcotte-Pugh satisfy the requirements of the listing, extensive cell damage on liver biopsy.
score, which has a refined scoring we will evaluate the effects of any Therefore, histological findings may not
system and has been validated for years debilitating symptoms when we assess correlate with functional capacity.
as predictive of mortality. This score residual functional capacity at later Others noted that extrahepatic
indicates cirrhosis as ‘‘compensated’’ steps in the sequential evaluation manifestations of chronic liver disease
and ‘‘decompensated.’’ process. cannot be found on liver biopsy, yet
Another commenter suggested that we We do agree that complications of these manifestations are symptomatic
should not use the Child-Turcotte-Pugh TIPS may occur. However, if there are and limiting.
score because it does not pick up some complications, immediate medical Also, in an apparent reference to our
disabilities, but we should use the attention would be required, and the proposal to remove the requirement for
MELD and PELD scoring systems which complications would not last or be confirmation of chronic liver disease by
have replaced it. expected to last for 12 months. liver biopsy in prior listing 5.05F,
Response: We partially adopted the commenters agreed that a biopsy should
We do not agree with the comment
suggestion to use a classification system not be mandatory. However, they
by including an SSA CLD score criterion that blood is not being filtered by the
indicated that the results of a biopsy
in final listing 5.05G, and SSA CLD and liver after a TIPS procedure. Portal
could help to assess whether an
SSCLD–P score criteria in final listings pressure is reduced by the TIPS
individual has cirrhosis, particularly
105.05G1 and G2. The SSA CLD and procedure, which connects the portal
early cirrhosis, since symptoms may not
SSA CLD–P calculations are based on vein to the hepatic vein using a stent
be substantiated by blood tests or
the calculations for the MELD and PELD (shunt); however, there is still some
physical examination.
scores, but we made minor changes to blood that filters through the liver. Response: We agree with the
these calculations to make them more Comment: Many commenters commenters that a liver biopsy is useful
appropriate for determining disability. disagreed with our proposal to remove in diagnosing cirrhosis, and in final
We did not base the SSA CLD–P prior listings 5.05E and 105.05E for 5.00D3c and 105.00D3c, we explain that
calculation on the Child-Turcotte-Pugh hepatic encephalopathy. They noted biopsy may demonstrate the degree of
score because it has been superseded by that this condition is directly related to liver cell necrosis, inflammation,
the PELD in clinical practice. end stage liver disease and affects an fibrosis, and cirrhosis. We also agree
Comment: Several commenters were individual’s ability to work due to with the commenters that a liver biopsy
concerned about our proposal to remove manifestations such as confusion, poor is not a good predictor of the severity of
prior listing 5.05B, for performance of a memory, and lack of concentration. symptoms of chronic liver disease or
shunt operation for esophageal varices. Many commenters also recommended their effect on functioning. Therefore, as
One commenter noted there are still that we include criteria for evaluating we explained earlier, we have removed
problems that can occur with the TIPS hepatic encephalopathy in the digestive prior listing 5.05F, which was based in
shunting procedure, such as occlusion, disorders listings rather than evaluating part on confirmation of chronic liver
infection, or failure. The commenter the condition in the mental or disease by liver biopsy. We will
noted that TIPS shunting does not have neurological body systems. Another continue to consider liver biopsy reports
any bearing on the severity of the commenter noted that TIPS can cause when they are part of the existing
condition that required the shunt. The encephalopathy, and said that doing medical records in combination with all
commenter also indicated that, although away with listings for shunts and the other evidence in the case record.
the shunt will help relieve the pressure hepatic encephalopathy was not a good Comment: Several commenters stated
causing the hemorrhage, it does not idea. that many of the medications and
bring about a recovery or improvement Response: We adopted the comments. procedures used to treat the symptoms
of the liver disease itself. Although we are still removing prior of liver disease, such as higher dose
The same commenter stated that, after listings 5.05E and 105.05E because they diuretics, repeated large-volume
a TIPS procedure, the blood is not being were reference listings that only referred paracenteses, and placement of TIPS for
filtered by the liver, but is bypassing to the mental disorders listings, we are bleeding esophageal varices, have side
liver function, and that blood toxicity is adding new listings for hepatic effects that we should consider. The
an issue. The commenter noted that encephalopathy that contain specific commenters noted that treatment can
TIPS prevents or postpones the next big evaluation criteria, final listings 5.05F lead to major electrolyte or renal
bleed, but does not cure the underlying and 105.05F. These final listings problems.
disease, usually cirrhosis. The include criteria for the behavioral or Response: We agree that the effects of
debilitating symptoms are not cognitive manifestations of hepatic treatment must be considered in
eliminated and the patient is unable to encephalopathy in combination with assessing digestive impairments. In final
perform work or normal lifestyle TIPS or any surgical portosystemic 5.00C and 105.00C, we provide general
functions. shunt or in combination with a specific guidance for how we consider the
Response: We did not adopt the clinical or laboratory finding. We are effects of treatment for all impairments
comments asking us to keep prior listing also providing guidance in final in this body system. In final 5.00D4 and
5.05B. As we indicated in the preamble 5.00D10 and 105.00D10 of the 105.00D4, we provide specific guidance
about how we consider the effects of individual who receives 5 units. The impairment that does not meet the
treatment for chronic viral hepatitis commenter thought that, since requirements of 5.05A because varices
infections. physicians and hospitals are reluctant to have been clipped may still meet the
Also, if an impairment does not meet transfuse blood, any blood transfusion requirements of final listing 5.05B
or medically equal a listing, we should suffice or the matter should at through 5.05G or be disabling on
continue to consider the effects of least be left to medical judgment. another basis.
treatment on the individual’s ability to Another commenter said that a Comment: One commenter stated that
function when we assess residual transfusion of ‘‘multiple’’ units of blood the mortality rate associated with
functional capacity, or for children, in conjunction with other interventions variceal bleeding has decreased over the
when we assess functional equivalence. in an attempt to restore hemodynamic last several years with advances in
Comment: Several commenters stability should suffice and that there therapy. If an individual goes more than
suggested that we add documented should be some latitude for medical a year without recurrent bleeding, he or
portal hypertension to listing 5.05A and judgment in this listing. she is back at baseline and has only a
105.05A. Another commenter stated that we 25 percent risk for bleeding. The
Response: We adopted the comment. should include other criteria to define a commenter recommended that we
Comment: One commenter suggested hemodynamically significant bleed, determine disability at that point by the
that proposed listing 105.05A was more such as at least a 2-unit bleed, or a drop state of decompensation of the liver
restrictive than proposed listing 5.02 for in blood pressure and increase in pulse rather than the risk of bleeding.
adults, with no corresponding rate. This commenter also suggested Response: All of the criteria in final
childhood listing 105.02 for children. changing the wording from listings 5.05 and 105.05 are based on the
The commenter suggested that we ‘‘hemodynamic instability’’ to state of decompensation of the liver
include a comparable listing for ‘‘hemodynamically significant bleed’’ in rather than the risk of bleeding. The
children based on three gastrointestinal the listing and the introductory text. requirement under 5.05A for
bleeds requiring transfusion in a 6- Response: We partially adopted the hemorrhaging that results in
month period due to any disease comments. We agree that the proposed hospitalization and transfusion reflects
process, not just esophageal varices. rule was too severe. Therefore, we one of the major complications of
Response: We adopted the comment revised the listing so that the primary chronic liver disease. When we
and added a corresponding childhood criterion for listing-level severity is determine whether an impairment that
listing 105.02 with essentially the same hemorrhaging that results in met 5.05A continues to be disabling
provisions as in final listing 5.02. hemodynamic instability and requires following the 1-year period of disability,
Comment: Many commenters hospitalization for transfusion. Since we evaluate any residual impairment(s),
recommended that we delete the word the minimum amount of blood a including bleeding and other
‘‘massive’’ from proposed listings 5.05A physician will usually transfuse in complications of chronic liver disease.
and 105.05A. They also suggested adults is 2 units, we used this amount Comment: One commenter stated that
including other sites of bleeding besides in the listing. the proposed language for the length of
the esophagus under listing 5.05A, In final 5.00D5, we also adopted some disability under listings 5.05A and
specifically bleeding from gastric and of the language suggested by 105.05A (that is, ‘‘for 1 year following
ectopic varices, and portal hypertensive commenters to describe hemodynamic the last documented massive
gastropathy. instability, including pallor, hemorrhage’’) did not work. The
Response: We adopted the comments diaphoresis, rapid pulse, low blood commenter suggested that the correct
and made corresponding changes to pressure, postural hypotension, and standard has to be the state of
final 5.00D5 and 105.00D5 of the syncope. (We also provide brief decompensation of the liver, not a fixed
introductory text which provide definitions of the more technical period of time.
guidance for applying listings 5.05A and medical terms on this list.) We do not Response: We did not adopt the
105.05A. We also changed the proposed indicate, as we did in the NPRM, that comment. As we explained in the
criteria of these listings, as we explain hemodynamic instability may require NPRM, we changed the period for
in our response to the next comment. multiple transfusions because final which we would presume the
Comment: Many commenters opposed listing 5.05A requires only one impairment is disabling from 3 years to
the requirement in proposed listing transfusion. 1 year because of newer techniques in
5.05A that an individual receive 5 units We made similar changes in the part the treatment of esophageal varices. (See
of blood in order for his or her B section for children, but provided a 66 FR at 57013.) The same logic would
impairment to meet the requirement for rule for documenting appropriate hold for other bleeds as well.
a massive hemorrhage. transfusion volumes based on body Also, it is important to remember that
One commenter stated that it would weight. the 1-year rule does not mean that
be more reasonable to simply require a Comment: One commenter noted that disability automatically ends 1 year
‘‘significant hemorrhage.’’ This some people could not meet listing following the last documented
commenter noted that any transfusion is 5.05A because they may have many transfusion (we removed the description
significant. large varices clipped. These individuals ‘‘massive hemorrhage’’ as we explained
Another commenter said that would be in serious danger and disabled earlier). Our rule is only that after 1 year
specifying the number of units without ever bleeding. we must consider whether the
transfused could not be supported Response: We agree that an individual impairment is still disabling. Also, our
because the size of the individual, the who has had prophylactic banding of existing rules allow our adjudicators to
protocol of the hospital, the timeliness varices without a bleed would not meet decide that we will not review a case
of the intervention, and other factors the requirements of final listing 5.05A. until a date later than 1 year after the
could influence the amount of blood However, one of the major qualifying event (in this case, the last
transfused. This commenter doubted complications of cirrhosis with portal documented transfusion), if the medical
that the prognosis for an individual with hypertension is bleeding varices; evidence supports a conclusion that the
bleeding varices who receives 4 units is therefore, a criterion for hemorrhaging is disability will continue for longer than
significantly better than for an appropriate in these listings. An 1 year.
Comment: One commenter objected to listings for malignant tumors of the Comment: Another commenter
the criterion in proposed listing 5.05B2a liver, listing 13.19 for adults and listing believed that our proposal to eliminate
for a cutoff level for serum albumin 113.03 for children. However, in prior listing 5.05C, which required
depletion, stating that the actual serum response to this comment, we added a chronic liver disease with elevated
albumin level is dependent upon many cross-reference to listing 13.19 in final serum total bilirubin, would be a ‘‘great
factors, such as hydration and the section 5.00D1 and to listing 113.03 in disservice’’ to individuals with primary
degree of portal hypertension. The final section 105.00D1. biliary cirrhosis (PBC), primary
commenter suggested that we change Comment: Several commenters stated sclerosing cholangitis (PSC), and
the listing criterion to ‘‘an associated that some hepatic conditions, such as autoimmune hepatitis (AIH). The
decrease in serum albumin.’’ Budd-Chiari syndrome, may not include commenter noted that elevated serum
Response: We did not adopt the cirrhosis or ascites, but are disabling total bilirubin levels and pruritis
comment. A serum albumin level of 3.5 and should be included as conditions associated with these conditions are
g/dL is normal. Even though a level for determining eligibility for disability very real problems. Also, a commenter
between 3.0 g/dL and 3.5 g/dL may benefits. noted that most primary care doctors are
indicate an abnormality, it is does not Response: We did not add all the not going to run studies other than the
reflect listing-level severity. A level of specific conditions mentioned by the serum total bilirubin.
3.0 g/dL or less is recognized by commenters to the listings. However, as Response: Even though serum total
hepatologists as indicative of loss of already explained, we did add several bilirubin studies may be readily
liver biosynthesis. criteria to final listing 5.05 and 105.05 available in the medical records from
We set the laboratory values in these to expand the scope of those listings and primary care physicians, we are
listings, such as the serum albumin to address additional manifestations of removing prior listing 5.05C because, as
level in 5.05B2a, at a level that reflects chronic liver disease. We also expanded we explained earlier, this laboratory
very serious impairment because we use the introductory text in 5.00D2 and finding alone is not a good indicator of
the listings only to deem individuals 105.00D2 to provide examples of impairment severity or an individual’s
disabled without considering any other chronic liver disease that should be ability to function. However, serum total
factors that may contribute to their considered under the listings when they bilirubin is one of the three laboratory
inability to work; that is, their residual result in the complications specified in values we use to calculate the SSA CLD
functional capacity, age, education, and the listings. We added guidance score for final listing 5.05G.
work experience. However, the regarding the effects of the extrahepatic In response to this comment, we are
establishment of these levels does not manifestations of chronic liver disease providing a list of examples of chronic
mean that individuals whose that should be considered under the liver disease in final 5.00D2. The list
impairments do not satisfy the criteria requirements of other body systems or at includes PBC, PSC, and AIH, and will
of the listing are not disabled; it only later steps in the sequential evaluation remind adjudicators that these
means that we do not presume that they process when the impairment does not conditions can be evaluated under final
are disabled under the listing. We may meet or medically equal a listing in the listing 5.05.
still find that the impairment is digestive disorders body system. Comment: One commenter stated that
disabling based on an individualized Comment: One commenter noted that doctors are finding that low platelet
assessment of its effects on the we proposed to remove the laboratory counts are an indicator of portal
individual’s functioning. values from prior listings 5.05C and hypertension and that they should be
Comment: One commenter suggested 5.05F and asked why we did not added to the criteria for listings 5.05 and
that we include a criterion for propose to delete the laboratory values 105.05. The commenter noted that
malabsorption with involuntary weight in proposed listing 5.05B. The patients are concerned about the
loss of 10 percent or more from baseline commenter recommended that we amount of physical activities they can
in the absence of a comorbid condition delete the values from listing 5.05B as perform with low platelet counts and
that could explain the findings. well. abnormal coagulation.
Response: We did not adopt the Response: We did not adopt the Response: We do not include low
comment because malabsorption is not comment. As we explained in the platelet counts as stand-alone criteria
a common feature of chronic liver NPRM (66 FR at 57013) and have for listing-level severity because there is
disease. However, individuals with explained earlier in this preamble, we a wide statistical variation in platelet
chronic liver disease and the did not propose to delete the laboratory counts, and there is no specific level at
appropriate degree of weight loss can values in proposed listing 5.05B because which individuals will subsequently
meet the requirements of final listings they are specific indicators of the bleed. We consider any functional
5.08 or 105.08. severity of the deterioration of liver consequences, such as limitations in an
Comment: Several commenters function in that listing. Serum albumin individual’s ability to perform physical
suggested that we change the measure of level is a good indicator of liver activity, when we assess residual
coagulation studies from prothrombin biosynthesis and it correlates with the functional capacity in adults and
time to International Normalized Ratio severity of ascites. In addition, blood functional equivalence in children.
(INR) as many laboratories do not report coagulation disorders resulting from However, in response to this
the prothrombin time in terms of chronic liver disease are indicative of comment, we added a reference to
seconds, but do report the INR. the severity of the liver dysfunction. abnormal coagulation studies, including
Response: We adopted the comment. However, as we explained earlier in this an increased INR level and decreased
Comment: Several commenters preamble, we are providing a criterion platelet counts, in our list of laboratory
suggested that we include hepatic for an elevated INR as a measure of the studies associated with chronic liver
malignancy as a criterion in listings 5.05 body’s ability to regulate coagulation, disease in final 5.00D3c and 105.00D3c.
and 105.05, noting that many liver rather than a prolongation of We explain that elevated INR level does
diseases result in hepatocellular prothrombin time as in the prior and indicate loss of synthetic liver function,
carcinoma. proposed listing, because INR is a more as well as increased likelihood of
Response: We did not adopt the widely used study than prothrombin cirrhosis and associated complications.
comment because we already have time. We also include an elevated INR level
in the criteria of listings 5.05B and listing, or meet the definition of require children to prove disability in
105.05B. disability later in the sequential other ways.
Comment: Proposed listings 5.05B evaluation process. Response: We adopted the comment.
and 5.06 contained criteria that required Comment: One commenter believed In final listing 105.05H, we have
specific findings to occur during a that we should not require clarified that the listing applies only to
consecutive 6-month period. documentation of ascites by both extrahepatic biliary atresia, thus
Commenters believed that our proposal physical examination and appropriate excluding other types, such as
to change the requirement that ascites medically acceptable imaging under intrahepatic biliary atresia. We are no
persist for 5 months in prior listing proposed listings 5.05B2 and 105.05B2. longer using ‘‘inoperable’’ to describe
5.05D to a requirement for 6 months in The commenter stated that imaging the condition, because by definition,
proposed listing 5.05B seemed arbitrary studies are not always available and extrahepatic biliary atresia cannot be
and unfair because not all impairments that, if ascites is observable on remedied with surgery except by liver
fit neatly into 6-month blocks. (There examination and the serum albumin or transplantation; the portoenterostomy
was no 6-month requirement in prior coagulation studies criterion in the procedure usually performed in the first
listing 5.06.) The commenters believed listing is fulfilled, it seems unnecessary 3 months of life is only palliative.
that we changed the listing simply to to also require documentation by Comment: One commenter believed
coincide with an arbitrary timeframe imaging. Another commenter noted that that our requirement for prolongation of
without regard for long-held it is difficult to demonstrate ascites in the prothrombin time of at least 2
understanding of medical severity. One obese people by physical examination, seconds in proposed listing 5.05B2(b)
commenter believed that the period was and requiring both types of was medically unreasonable and might
excessive because clinically significant documentation could reduce the chance be excessive. The commenter suggested
ascites for 3 months despite treatment that an individual who is obese would that any reading above the normal value
represents serious liver disease. benefit from this listing. for the reporting laboratory should
Another commenter questioned how Another commenter stated that our
qualify.
we would handle cases in which the Response: We disagree with the
proposed listing 5.05B criteria did not
appropriate findings persist comment; however, we have removed
quantify the amount of ascites and that the proposed criterion for measurement
consecutively over a 2- to 5-month
we should be evaluating significant of prothrombin time and instead
period, improve for a few months, and
ascites. provided a criterion for INR in final
then recur for a few months. The
Response: We adopted the first two listing 5.05B2 because INR is a more
commenter asked if a case involving
comments by providing in final listing widely used study than prothrombin
multiple recurring periods, none of
which individually lasts up to 6 5.05B2 that ascites or hydrothorax can time. As we explained earlier, because
consecutive months, could equal either be demonstrated by appropriate we use the listings to deem individuals
of these listings. medically acceptable imaging ‘‘or’’ by disabled, we must set laboratory values
Response: As we explained in the physical examination. Since the in the listings at levels that reflect very
NPRM, ‘‘[i]n our experience, requiring 6 required laboratory findings in final serious impairment.
months of persistent findings enables us listings 5.05B2 establish the severity of Comment: One commenter suggested
to make a more reliable prediction of the impairment under the listings, we that we include in listing 105.05
listing-level severity.’’ (See 66 FR at agree that there is no need to require consideration of poor school
57013.) Requiring findings from at least documentation of ascites both on performance, difficulties in play, and
two evaluations, at least 60 days apart, physical examination and on imaging. growth and developmental delays. The
within a consecutive 6-month period Because of this change in the final rules, commenter gave examples of
allows us to document the recurrent or individuals with obesity will be able to developmental delays due to ascites,
persistent nature of many of these meet this listing with ascites such as inability to roll over.
impairments and is a more reliable demonstrated on imaging techniques Response: We did not include this
indicator that the impairment will be alone, provided they meet the other information in the listing, but in
disabling for 12 consecutive months. criteria of the listing. response to this comment we did note
When these listing requirements are Because of this comment, we also in final 105.00D3 in the introductory
satisfied, we can generally conclude that reviewed the same criterion in proposed text that the manifestations of chronic
the impairment will be disabling for 12 listing 105.05. For consistency, and liver disease may include
consecutive months. because it is medically appropriate, we developmental delays or poor school
In the two examples provided by the included the same requirements for performance. The issues raised by this
commenters (that is, clinically children in final listing 105.05B as we comment are more appropriately
significant ascites for 3 months despite do for adults in final listing 5.05B. We addressed when we make functional
treatment, or findings persisting for 2 to also restored the criterion from prior equivalence determinations under
5 months that improved for a few listing 105.05B for an associated serum § 416.926a, where we provide detailed,
months and then recurred), the albumin of 3.0 g/dL or less and added age-specific guidelines for evaluating
impairments would meet the listing if a criterion for an INR of 1.5 consistent limitations in school, play, and various
there was evidence showing the with final listing 5.05B. This will ensure other developmental issues.
required findings on two evaluations that the ascites is a sign of chronic liver Comment: Many commenters stated
spaced at least 60 days apart. These disease. that we should include a separate listing
examples show that we do not Because we are requiring the for chronic hepatitis B and C. Some
necessarily need 6 months of evidence associated laboratory studies with the suggested that we do not recognize the
to find that an impairment meets the ascites to demonstrate listing-level hepatitis C virus as a disability and they
listing. Also, as we have already noted, severity, we will not need to quantify believed that it is ‘‘unacceptable’’ to
if the impairment does not meet the the amount of ascites. evaluate individuals with chronic
criteria of any of these final listings, it Comment: One commenter hepatitis C virus under the chronic liver
may meet the criteria of a listing in recommended that we not delete listing disease listings. Some commenters
another body system, medically equal a 105.05A, inoperable biliary atresia, and thought that our proposals would
restrict individuals with hepatitis C hepatitis B or C; rather, we intend to capacity or, for children, age-
from receiving benefits. One commenter include everyone who should qualify appropriate functioning.
said that our proposed changes did not under our rules. The new information in Also, we do not believe we should
take into account knowledge gained in final 5.00D4 and 105.00D4 will also add a functional listing to the final rules
the last 20 years regarding the hepatitis ensure that our adjudicators have up-to- without first proposing it and asking for
C virus. Some commenters thought we date information about hepatitis B and public comment on the criteria it might
were removing hepatitis C and all liver C. contain. Therefore, even though we are
diseases from the listings, while others Comment: Some commenters not adding such a listing now, we plan
suggested that we wrote the chronic indicated that the debilitating symptoms to issue an Advance Notice of Proposed
liver disease listings only for alcoholic of hepatitis C virus often begin decades Rulemaking inviting public comments
and drug-induced liver failure. before end-stage liver failure occurs. on whether we should add a functional
Response: We are not removing Some commenters recommended that listing to the digestive disorders body
chronic liver disease from the listings, we include criteria for hepatitis like the system and, if so, what functional
and we do recognize and include criteria in listings 14.08N and 114.08O, criteria would be appropriate.
hepatitis C, which is a chronic liver for human immunodeficiency virus With regard to the comment that we
disease, under final listings 5.05 and (HIV). Those listings provide for a should add a listing based on functional
105.05. finding of disability based on significant limitations for individuals who are
We believe that the many changes and documented symptoms or signs with homeless, we do not believe we should
improvements we are making in the specified functional limitations. The add a listing at this time for the reasons
final listings and the introductory text commenters indicated that the stated above; however, we do evaluate
in response to these and other symptoms and signs of hepatitis, such functional limitations that result from
comments will make clear that final as decreased cognitive function, the symptoms and signs of an
listings 5.05 and 105.05 apply to all decreased memory acuity, fatigue, impairment when we assess residual
forms of chronic liver disease, including weakness, fever, malaise, lethargy, functional capacity.
disease caused by the hepatitis B and C weight loss, abdominal pain, appetite We agree with the physicians who
viruses. As we have already explained, disturbance, mood disturbance, and spoke at the outreach meeting that the
final listings 5.05 and 105.05 are now insomnia, are in many respects the same fatigue associated with hepatitis B and
broader in scope and more inclusive as the symptoms and signs we include C is often substantial but also difficult
than the proposed listings were. We did in listings 14.08N and 114.08O. The to assess and validate. We also agree
not add a separate listing for chronic commenters noted that both HIV and that treating physicians can provide
hepatitis B or C because individuals chronic hepatitis B and C are systemic important information about the validity
with listing-level effects of hepatitis will illnesses that encompass a broad and impact of fatigue on functioning. In
have the same kinds of findings as those spectrum of diseases and potential fact, our regulations at §§ 404.1527 and
associated with other chronic liver impairments with many constitutional 416.927 require us to consider medical
diseases. and systemic signs and symptoms. source opinions about the nature and
In response to these and other One commenter stated that including severity of impairments, including
comments about chronic viral hepatitis, a listing based on functional limitations opinions about symptoms and their
we are also adding extensive sections to would be important for individuals who effects on functioning. However, these
the introductory text to address many of are homeless and whose functional same rules do not allow us to rely solely
the concerns expressed in the comment disabilities may be very profound. The on the judgment of the treating
letters and at the outreach conference. commenter noted that it would be easier physician, as the commenters may have
Final 5.00D4 and 105.00D4, which to document the functional limitations been suggesting. The rules identify
explain how we evaluate chronic viral than the medical conditions because factors we must consider in determining
hepatitis, are the longest sections in the expert medical care may not be whether to accept a treating source’s
introductory text. We have provided available to this group. medical opinion, including an opinion
subsections explaining: A group of physicians who spoke at about an individual’s symptoms. We
• The nature and course of hepatitis the outreach meeting commented that must also evaluate the symptom of
B and C infections; they ‘‘struggled with the dilemma of’’ fatigue under §§ 404.1529 and 416.929
• Treatment, including the adverse how we should evaluate fatigue because of our regulations, which provide a
effects of treatment; and they believe it is subjective and difficult variety of factors that we must consider.
• Extrahepatic manifestations of to assess and validate. They Comment: One commenter suggested
hepatitis B and C. recommended that the assessment of the that hepatitis C should be included in
With these changes, we believe it will validity and impact of fatigue should the hematological body system (7.00
now be very clear that we do consider rest on the judgment of the treating and 107.00) since it is a blood-borne
hepatitis B and C to be medically source. virus.
determinable impairments that could be Response: We did not adopt the Response: We did not adopt the
the basis for a finding of disability. We comments. While we agree that some comment because hepatitis is primarily
explain how these impairments can individuals with hepatitis B and C may a liver disorder and should be evaluated
meet the requirements of final listings be debilitated by symptoms of fatigue in the digestive disorders body system.
5.05 and 105.05, and how they can be and the other symptoms mentioned by Comment: One commenter stated that
disabling in other ways, either by the commenters, we believe it would be only those individuals who suffer from
meeting other listings, medically more appropriate to consider these hepatitis C know the extent of their
equaling listings, or based on the symptoms on a case-by-case basis at symptoms and only they should make
functional consequences of the later steps of the sequential evaluation judgments about the appropriate
impairments as a result of symptoms process, based on information obtained disability criteria for this disease.
and the effects of treatment. It should from the treating source(s) as well as Another commenter recommended
also be clear that we do not intend to other medical and non-medical sources that we employ doctors who deal with
restrict the entitlement to disability concerning the particular effects of the a large number of patients with
benefits of individuals who have impairments on residual functional hepatitis. The commenter further
recommended that we consult with the and 416.904 of our regulations, we are Comment: One commenter
American Association for the Study of required to make a determination of recommended that we include a
Liver Disease (AASLD) for a list of disability independent of other reference to hepatitis B under recurrent
experts in the field. Another commenter agencies, such as the VA. Also, the and persistent syndromes because
indicated that some doctors who do not disability standard the VA uses is not chronic fatigue syndrome (CFS) and
deal regularly with an indigent the same as our disability standard. depression are common symptoms and
population or those that have retired However, our regulations do provide these functional limitations are
from active practice may not have that we must consider determinations debilitating and prevalent enough that
expertise in assessing hepatitis B and C. made by other agencies, including the they merit inclusion.
The commenter recommended that VA, when we make our determinations Response: We did not adopt this
community health centers or other and decisions (see §§ 404.1504, comment but we did provide guidance
public entities should be used as a 404.1512(b)(5), 416.904, and on hepatitis B in final 5.00D4b and
source of medical expertise. 416.912(b)(5)). 105.00D4b. We did not include a
Response: As we note at the beginning The reason that a decision awarding reference to CFS in this final rule partly
of the comment and response section of disability benefits for the Railroad because it is a diagnosis of exclusion;
this preamble, we reopened the Retirement Board sometimes applies to that is, the diagnosis is not made if
comment period on the NPRM so that Social Security disability benefits is that another physical or mental impairment,
we could receive additional input on there is a law that permits this such as hepatitis, is present that can
our rules for evaluating chronic liver presumption. Also, the determinations account for the symptoms. We explain
disease. In addition to the outreach of disability that we accept use the same our policy for evaluating CFS in Social
meeting we conducted in Cambridge, standard that we use for determining Security Ruling 99–2p, ‘‘Titles II and
Massachusetts in November of 2004, at disability under our programs; in some XVI: Evaluating Cases Involving Chronic
which a number of experts presented, cases, we make the determination of Fatigue Syndrome (CFS),’’ 83 FR 23380
we also asked other people with disability that the Railroad Retirement (April 30, 1999).3
expertise to send us written comments. Board uses. Comment: Many commenters stated
As a result of these efforts, we received Comment: One commenter suggested that individuals undergoing interferon/
many comments from medical that hepatitis C should be a category for ribavirin treatment for hepatitis C
specialists, advocates who specialize in SSA disability at the point of diagnosis, cannot work as the treatment seriously
chronic liver disease (including stating that genotyping and treatment interferes with physical and mental
hepatitis B and C), and patients. We costs are prohibitive. This commenter stamina. One commenter observed that
adopted many of the comments from stated that there was no help for those it was unfair to patients and employers
these individuals. to expect those who are undergoing
in the interim between contracting the
We generally agree with the treatment for hepatitis C to work due to
disease and being near death under the
commenters who indicated that it the side effects of the treatment. They
would be better if we used doctors in current standards, and those individuals
must go without any assistance for years asked us to use compassion when we
our program who have expertise in make decisions regarding changes in the
evaluating and treating individuals with until they meet the criteria in the
chronic liver disease listings. chronic liver disease criteria. Another
hepatitis, or any chronic liver diseases, commenter stated that disability
and we do use such experts whenever Another commenter noted that the
symptoms of hepatitis C virus infection benefits would be helpful for patients
possible. We also asked the Institute of when going through treatment or
Medicine of the National Academies to make learning a new, less strenuous
trade an unrealistic option if an transplant as the symptoms attack on all
study the issue of medical expertise in fronts.
our disability evaluations and to individual does not become
symptomatic until later in life. Response: Partly in response to these
recommend ways in which we can make comments, we included guidance in
better use of medical expertise in our Response: While we understand the
concern of the first commenter, we do final 5.00D4 and 105.00D4 about the
case adjudications. They issued their types of treatment for hepatitis C,
report, Improving the Social Security not have the authority to do what the
commenter asked. To qualify for Social including interferon/ribavirin treatment
Disability Decision Process, on February for adults and children, and the
13, 2007.2 We are now considering their Security Disability Insurance or
Supplemental Security Income benefits, common adverse effects of treatment.
findings and recommendations for However, we cannot automatically grant
future improvements. individuals must show that they are
disabled under the definition of disability benefits if an individual is
Comment: One commenter said that a undergoing treatment for hepatitis B or
Veterans Administration (VA) disability disability in the Act.
C. Everyone reacts differently to the
rating of 100 percent due to hepatitis C Likewise, with regard to the second
treatment and we must evaluate the
should trigger automatic payment of comment, we cannot pay disability
disease progression, side effects of
Social Security disability benefits, as it benefits under the Act to individuals
treatment, and response to treatment on
does for disabled railroad employees. who are not currently disabled but who
an individual basis, unless in the future
The commenter stated that this would may become disabled in the future.
we can identify a diagnostic technique
save tax dollars and eliminate inequity However, at the fifth step of our
that would allow us to use a conclusive
between the two Federal programs. sequential evaluation process (described
presumption that a case of hepatitis is
Response: We did not adopt the near the end of this preamble) we do
so severe the individual cannot, as a
comment. Under sections 205(b)(1) and consider an individual’s age, education,
practical matter, engage in any gainful
1631(c)(1)(A) of the Act and §§ 404.1504 and work experience. At this step, the
activity.
older an individual becomes, the more
Comment: Some commenters
2 Institute of Medicine of the National Academies, likely it is that we will find the
Committee on Improving the Disability Decision suggested that we should include
individual unable to make an
Process. Improving the Social Security Disability
Decision Process. Washington, DC: The National
adjustment to other work; that is, the 3 The ruling is also available at http://www.social
Academies Press, 2007. The report is available at more likely we will find that the security.gov/OP_Home/rulings/di/01/
http://www.nap.edu/catalog.php?record_id=11859. individual is disabled. SSR99=02=di=01.html.
neuropsychological testing in the said that profound fatigue due to the other manifestations of IBD mentioned
evaluation of any person seeking Social underlying inflammatory disease or the by the commenters.
Security disability benefits for chronic resulting and often complex nutritional The new sections in the introductory
liver disease, regardless of liver deficiencies that accompany these text include most of the examples of
histology, because 50 percent of disorders may be incapacitating. The symptoms and signs of IBD that the
individuals with chronic hepatitis C commenters mentioned several commenters mentioned, as well as
experience cognitive impairment and symptoms and signs that could be others that the commenters did not
chronic fatigue, even in individuals refractory to medical and surgical specifically mention, including a longer
with mild liver disease. treatment; for example, recurrent list of potential manifestations in other
Response: We did not adopt the obstruction, anemia, fistulae, abscess, or body systems than we included under
comment. Neuropsychological testing is other perineal or intra-abdominal the prior listings. In addition, we
highly specialized, and we generally try complications. They also noted that revised proposed listings 5.06 and
to exhaust all other or more direct recurrent and persisting severe diarrhea, 105.06 by adding a list of six
avenues before we purchase such with or without incontinence, makes it manifestations in paragraph B of final
testing. Also, the testing examines fine impossible for many individuals with listing 5.06 and a list of five
areas of brain functioning and not the IBD to sustain any activity for even manifestations in paragraph B of final
global functioning that we are generally modest periods of time. One of the listing 105.06.
most interested in for our disability commenters stated that many of the We did not include criteria for
evaluations. most challenging symptoms of IBD manifestations like severe diarrhea or
Comment: Several commenters cannot be directly quantified by the fecal incontinence. We believe that the
suggested that the medical criteria be usual objective studies, including effect of severe diarrhea is best
kept in line with the National Institutes imaging or laboratory tests, resulting in identified at the listing level by the
of Health (NIH) Consensus Statement on our excluding relief to many who need criteria in 5.06B1 and 105.06B1 (anemia
the Management of Hepatitis C (the and deserve it. with a hemoglobin of less than 10 g/dL)
Consensus Statement).4 Another commenter stated that we and 5.06B2 and 105.06B2 (serum
Response: With the additional did not sufficiently address recurrent albumin of 3.0g/dL or less). We agree
material we added as described above, diarrhea and bowel incontinence that do that there are other consequences of
we believe that these final rules are not lead to weight loss or malnutrition. severe diarrhea or fecal incontinence,
consistent with the Consensus This commenter noted that these such as the necessity to be near a
Statement to the extent appropriate for conditions may require proximity to a restroom or the difficulty of sustaining
our disability evaluation criteria under restroom or may interfere with the activities for even modest amounts of
the listings. There is a considerable ability to work in public. The time, that may significantly affect an
amount of information in the Consensus commenter acknowledged that they are individual’s ability to work or a child’s
Statement that is not specifically ‘‘probably not’’ listings issues, but said ability to function in an age-appropriate
relevant to our disability adjudications that there did not appear to be sufficient manner. However, we believe these
(for example, discussion of treatment guidance for disability adjudicators on consequences of IBD are more
options and recommendations for more how to consider these issues. appropriately addressed on an
education and research) or that goes Two individuals who have IBD and individual case basis when we assess
beyond what is appropriate to include who had filed claims for disability residual functional capacity or
in our listings. benefits described how profound the functional equivalence.
disease was for them and expressed In considering these comments, we
Listings 5.06 and 105.06 Inflammatory concern about any changes we might also noted that there were unintentional
Bowel Disease make that would make it more difficult differences between proposed listings
Comment: We received many to qualify. One of these commenters, 5.06B and 105.06B, and that we
comments about IBD. Some commenters who has Crohn’s disease, described the included proposed 105.00F4 (final
were concerned that the listings focused embarrassment of the disease and the 105.00E) specifically for children but no
on recurrent intestinal obstruction or other kinds of illnesses she has had that corresponding guidance in proposed
fistulae as practically the only criteria are associated with the disease and its part A for adults. In making the
for disability due to IBD. The treatment. The other commenter said revisions in the final rules, we
commenters agreed that most that he was against any change in our determined that, with minor exceptions,
individuals with IBD respond to present regulations that would make it there was no need for the information in
medical or surgical treatment and lead more difficult for a person with IBD to part A to be different from the
fairly normal lives, but they indicated qualify for disability benefits. He said information in part B. Therefore, we
that there is a subset of individuals who that the proposed changes would cause added final 5.00E to correspond to final
have recurring and persisting disease an added hardship for individuals with 105.00E, and we made a number of
that is refractory to treatment and makes IBD. editorial changes to 105.00E for
them unable to work. The commenters Response: We adopted most of the consistency between the two sections.
suggested that many of these comments and completely revised Final 5.00E and 105.00E and final
individuals would not be covered by the proposed listings 5.06 and 105.06 and listings 5.06 and 105.06 are the same,
proposed listings and would face the introductory text for IBD. In except for the minor differences
difficulty with their claims. response to these comments, we added necessary to address childhood
The commenters indicated that final 5.00E in the introductory text in disability that we have already noted in
individuals with IBD can be part A and revised and expanded the explanations of the final rules at the
incapacitated by persistent abdominal proposed 105.00F4 (final 105.00E) in beginning of this preamble.
pain that may be unassociated with part B to provide more detailed With regard to the last comments
either obstruction or fistulae. They also guidance for documenting and expressing concern that our changes
evaluating IBD in adults and children. may make it more difficult for
4 http://consensus.nih.gov/2002/2002Hepatitis We also added criteria in final listings individuals with IBD to qualify for
C2002116PDF.pdf. 5.06 and 105.06 to include some of the disability benefits, we believe that the
changes we are making in these final former laboratory measurement is more loss, such as edema, anemia,
rules are an improvement over the accurate. hypoalbuminemia, hypokalemia,
proposed rules that address many of the hypocalcemia, and hypomagnesemia. If
Listing 5.08 Weight Loss Due to Any
commenters’ concerns. Also, the final the impairment does not meet or
Digestive Disorder
rules are consistent with advances in medically equal a listing, we will
medical science and technology, our Comment: A commenter suggested continue our evaluation through the
adjudicative experience, and our goal of that we include guidance that height be sequential evaluation process.
appropriately finding all individuals measured without shoes in the
who are unable to perform any gainful introductory text to the listings. Another Listing 105.08 Malnutrition
activity disabled under the listings. commenter noted that, although we Comment: Two commenters suggested
Comment: One commenter stated that explained in the NPRM how to round that we move the guidelines for what is
he was ‘‘perplexed’’ by the statement in inches and centimeters, we did not needed to document malnutrition from
the preamble to the NPRM that ‘‘anemia, explain how to round pounds and proposed 105.00F of the introductory
when caused by inflammatory bowel kilograms. text into listing 105.08 because they
disease, is not an appropriate indicator Response: We adopted the first were so specific.
of listing-level severity.’’ (See 66 FR at comment. Because the final listings are Response: We adopted the comments
57013.) The commenter noted that we based on BMI, we now explain in final and included three of the proposed
have long held that chronic anemia with 5.00G2a that measurements of both examples as criteria in final listing
persistent hematocrit below 30 percent weight and height must be made 105.08A. We did not include the
is of listing-level severity. The without shoes. example of steatorrhea for reasons we
commenter asserted that people with We did not need to adopt the second have already explained. Also, as
chronic anemia are tired, fatigued, and comment because we changed the explained earlier, we changed the
have poor stamina, and that there are weight loss criteria to BMI criteria in final 105.08A1 for anemia to
other factors that affect their ability to measurements and as a consequence a hemoglobin of less than 10.0 g/dL.
function. removed the proposed rule for Comment: One commenter suggested
Another commenter stated that our rounding. Because of this change, we that we specify that we use the most
proposed reasons for changes to the also did not include the height and current edition when we refer to the
listing were inaccurate. The commenter weight tables from proposed listing CDC chart in listing 105.08 and in the
questioned our statement that ‘‘a 5.08. introductory text. This would ensure
gradual reduction in hemoglobin, even Comment: Two commenters believed that the listing criteria continue to
to very low levels, is often well tolerated that the height and weight tables in the reflect the latest guidance.
and does not correlate with ability to regulations did not reflect the chronicity Response: We adopted the comment.
function.’’ (See 66 FR at 57013.) The and severity of disease in individuals The change appears in final 105.00G2
commenter stated that studies show that with IBD who are routinely treated with and in final listings 105.08B1 and B2.
quality of life and functional status corticosteroids. The commenters
correlate with hemoglobin levels. indicated that corticosteroids lead to Listings 5.09 and 105.09
Response: It is true that we have long substantial salt and water retention and Comment: One commenter suggested
had listings that are met with anemia increased fatty tissue accumulation, so that as long as an individual is required
demonstrated by hematocrits of 30 that nutritionally depleted patients may to take anti-rejection drugs after a
percent or less. We also agree that have artificially sustained weight. They transplanted organ, at the very least,
anemia may cause the kinds of also noted that it is not uncommon for medical benefits should continue.
symptoms listed. However, listing patients with crippling symptoms, Response: We did not adopt this
criteria must represent a level of hypoalbuminemia, and nutritional comment because we do not have the
severity that prevents ‘‘any gainful deficiencies to have ‘‘normal’’ or authority to do what the commenter
activity.’’ We cannot presume, based increased weight due to the asked. We can only pay benefits to
only on low hematocrit (or hemoglobin) corticosteroids. individuals who are under a disability
levels, that the symptoms referred to Response: We agree with the as defined in the Act and our
will be present or sufficiently severe in commenters that individuals with IBD regulations, and Medicare and Medicaid
all cases to determine that an individual may have ‘‘normal’’ weight; however, benefits generally depend on continuing
is disabled. The body adapts to a final listing 5.08 is specifically for entitlement to disability benefits.
gradual lowering of hematocrit (or individuals with weight loss as a Comment: One commenter stated that
hemoglobin) levels, therefore there is consequence of a digestive disorder. disability benefits should last for 18
not a strong correlation between Individuals whose impairments do not months after a liver transplant because
hematocrit levels and the ability to meet listing 5.08 may still meet the transplants do not remedy the
function. We removed a similar criteria of another listing. As we underlying cause of the disease, such as
criterion from the genitourinary system explained earlier, we have significantly viral hepatitis.
listings for the same reason. See 70 FR expanded final listings 5.06 and 105.06 Response: We did not adopt this
38582, 38586 (2005). to include criteria for many of the comment because in our experience 12
However, we have included a symptoms and signs of IBD. For months is a sufficient period after which
criterion for anemia with hemoglobin of example, we have included criteria in we need to reevaluate each individual’s
less than 10 g/dL as one of the criteria final 5.06B1 and B8 under which status to see if he or she is still disabled.
of final listings 5.06B and 105.06B. We individuals with IBD who are This is the period we provide for most
believe that it is an appropriate criterion nutritionally depleted but have other transplants. See, for example,
when it occurs in conjunction with at sustained weight may qualify. Also in listings 3.11 (lung), 4.09 (heart), 6.02
least one of the other manifestations of response to these comments, we have (kidney), 7.17 (aplastic anemia with
IBD listed in the final rules. We are provided examples in final 5.00E2 and bone marrow or stem cell
using hemoglobin (measured in units of 105.00E2 of signs and laboratory transplantation), and 13.05 (lymphoma
g/dL) rather than hematocrit (percent) in findings that may demonstrate with bone marrow or stem cell
assessing the degree of anemia as the malnutrition in the absence of weight transplantation). Also, we published the
liver transplant listing in 2002 in removing that reference listing without Response: We did not adopt the
another notice; these final rules do not replacement; however, as we have comment. We are not aware of any
make any substantive changes to that already noted, we have added references current medical distinction that
rule, only editorial revisions. And as we to growth impairment in the supports the suggestion.
have already noted, the 1-year rule does introductory text to these listings and
Additional Information
not mean that an individual’s disability we believe that this is sufficient.
automatically ends 1 year after the We do not agree that the prior What programs do these final rules
transplant. Our rule is only that after 1 reference listings were especially affect?
year we generally will consider whether helpful to adjudicators. All individuals
the individual is still disabled. Our who would qualify under any of the These final rules affect disability
existing rules also allow our provisions of our prior reference listings determinations and decisions that we
adjudicators to set a later diary date for will continue to qualify under other make under title II and title XVI of the
review of continuing disability if the listings or the rules for medical or Act. In addition, to the extent that
facts of the case warrant it. functional equivalence for children. Medicare entitlement and Medicaid
Also, because reference listings are eligibility are based on whether you
Other Comments qualify for disability benefits under title
redundant, we are removing them from
Comment: One commenter did not all the body systems as we revise them; II or title XVI, these final rules also
support our proposal to remove therefore, we would be inconsistent if affect the Medicare and Medicaid
reference listings. The commenter we retained reference listings only in programs.
believed that it is easier for our this body system. Our adjudicators are
adjudicators to recognize the need to Who can get disability benefits?
aware that the listings do not include all
document and evaluate an impairment Under title II of the Act, we provide
possible disabling impairments, so they
if it is also included in the listing itself. for the payment of disability benefits if
review all of the evidence, including the
The commenter also noted that you are disabled and belong to one of
claimant’s allegations and the medical
reference listings assure the public and the following three groups:
evidence from treating and other
their physicians that a specific
impairment has been considered.
medical sources, to identify the • Workers insured under the Act;
Response: We did not adopt the impairments they must evaluate. • Children of insured workers; and
comment. With one exception, all of the Comment: One commenter suggested
that we include some discussion in the • Widows, widowers, and surviving
reference listings in the part A digestive divorced spouses (see § 404.336) of
disorder listings were to listing 5.08, the introductory text of how to evaluate
digestive impairments for which there is insured individuals.
listing for weight loss. We believe that
our adjudicators, the public, and their no specific listing, such as peptic ulcer Under title XVI of the Act, we provide
physicians will easily see that final disease and chronic pancreatitis. for Supplemental Security Income (SSI)
listing 5.08 is applicable to weight loss Response: We did not add specific payments on the basis of disability if
due to any digestive disorder. The only information in the introductory text you are disabled and have limited
exception in part A was for hepatic about peptic ulcer disease or chronic income and resources.
encephalopathy, which cross-referred to pancreatitis because we prefer to How do we define disability?
listing 12.02; however, we have now include information that is relevant to
added a listing specifically for hepatic the application of these listings. Under both the title II and title XVI
encephalopathy (final listing 5.05F) in However, we do make it clear that we programs, disability must be the result
the digestive disorders listings. Part B may evaluate digestive disorders that of any medically determinable physical
was essentially the same, with most are not specifically named in the or mental impairment or combination of
reference listings cross-referring to introductory text under this body impairments that is expected to result in
listing 105.08, and a reference listing for system. death or that has lasted or can be
hepatic encephalopathy, which we now Comment: One commenter asked that expected to last for a continuous period
list in final listing 105.05F. Prior listing we consider the unique health risks and of at least 12 months. Our definitions of
105.07C also referred to growth cultural issues that affect Asian disability are shown in the following
impairment listing 100.03. We are Americans and immigrant communities. table:
Disability means you have a medically determinable impairment(s) as

If you file a claim under . . . And you are . . . described above that results in . . .
title II ................................................ an adult or a child .......................... the inability to do any substantial gainful activity (SGA).
title XVI ............................................ an individual age 18 or older ......... the inability to do any SGA.
title XVI ............................................ an individual under age 18 ............ marked and severe functional limitations.
How do we decide whether you are 1. Are you working, and is the work impairment or combination of
disabled? you are doing substantial gainful impairments that significantly limits
activity? If you are working and the your physical or mental ability to do
To decide whether you are disabled work you are doing is substantial basic work activities, we will find that
under the Act, we use a five-step gainful activity, we will find that you you are not disabled. If you do, we will
‘‘sequential evaluation process,’’ which are not disabled, regardless of your go on to step 3.
we describe in our regulations at medical condition or your age,
3. Do you have an impairment(s) that

§§ 404.1520 and 416.920. We follow the education, and work experience. If you meets or medically equals the severity
five steps in order and stop as soon as are not, we will go on to step 2. of an impairment in the listings? If you
we can make a determination or 2. Do you have a ‘‘severe’’ do, and the impairment(s) meets the
decision. The steps are: impairment? If you do not have an duration requirement, we will find that
you are disabled. If you do not, we will listings. Part B contains criteria that who is eligible for SSI payments, we
go on to step 4. apply only to individuals who are under follow a similar rule after we decide that
4. Do you have the residual functional age 18. If your impairment does not you have experienced medical
capacity to do your past relevant work? meet the criteria in part B, we may then improvement in your condition(s). See
If you do, we will find that you are not use the criteria in part A when those § 416.994a(b)(2).
disabled. If you do not, we will go on criteria give appropriate consideration
to the effects of the impairment(s) in What is our authority to make rules and
to step 5.
5. Does your impairment(s) prevent children. (See §§ 404.1525 and 416.925.) set procedures for determining whether
you from doing any other work that If your impairment(s) does not meet a person is disabled under the statutory
exists in significant numbers in the any listing, we will also consider definition?
national economy, considering your whether it medically equals any listing; Section 205(a) of the Act and, by
residual functional capacity, age, that is, whether it is as medically severe reference to section 205(a), section
education, and work experience? If it as an impairment in the listings. (See 1631(d)(1) provide that:
does, and it meets the duration §§ 404.1526 and 416.926.)
The Commissioner of Social Security shall
requirement, we will find that you are What if you do not have an have full power and authority to make rules
disabled. If it does not, we will find that impairment(s) that meets or medically and regulations and to establish procedures,
you are not disabled. equals a listing? not inconsistent with the provisions of this
We use a different sequential title, which are necessary or appropriate to
evaluation process for children who We use the listings only to decide that carry out such provisions, and shall adopt
apply for payments based on disability you are disabled or that you are still reasonable and proper rules and regulations
under SSI. If you are already receiving disabled. We will not deny your claim to regulate and provide for the nature and
benefits, we also use a different or decide that you no longer qualify for extent of the proofs and evidence and the
benefits because your impairment(s) method of taking and furnishing the same in
sequential evaluation process when we
does not meet or medically equal a order to establish the right to benefits
decide whether your disability hereunder.
continues. See §§ 404.1594, 416.924, listing. If you are not working and you
416.994, and 416.994a of our have a severe impairment(s) that does Regulatory Procedures
regulations. However, all of these not meet or medically equal any listing,
we may still find you disabled based on Executive Order 12866
processes also include steps at which
we consider whether your impairment other rules in the sequential evaluation We have consulted with the Office of
meets or medically equals one of our process that we use to evaluate all Management and Budget (OMB) and
listings. disability claims. Likewise, we will not determined that these final rules meet
decide that your disability has ended the criteria for a significant regulatory
What are the listings? only because your impairment(s) does action under Executive Order 12866, as
The listings are examples of not meet or medically equal a listing. amended. Thus, they were subject to
impairments that we consider severe Also, when we conduct reviews to OMB review.
enough to prevent you as an adult from determine whether your disability Our proposed rules met the criteria
doing any gainful activity. If you are a continues, we will not find that your for an economically significant
child seeking SSI payments based on disability has ended because we have regulatory action under Executive Order
disability, the listings describe changed a listing. Our regulations 12866. They were also ‘‘major’’ rules
impairments that we consider severe explain that, when we change our under 5 U.S.C. 801ff. For the reasons
enough to result in marked and severe listings, we continue to use our prior stated earlier in this preamble, these
functional limitations. Although the listings when we review your case, if final rules reflect changes we have made
listings are contained only in appendix you qualified for disability benefits or from the proposed rules. Based on these
1 to subpart P of part 404 of our SSI payments based on our changes, we estimate that these final
regulations, we incorporate them by determination or decision that your rules will result in program savings but
reference in the SSI program in impairment(s) met or medically equaled will not constitute an economically
§ 416.925 of our regulations, and apply a listing. In these cases, we determine significant regulatory action or ‘‘major’’
them to claims under both title II and whether you have experienced medical rules.
title XVI of the Act. improvement, and if so, whether the
medical improvement is related to the We are projecting savings in program
How do we use the listings? ability to work. If your condition(s) has expenditures as described below.
The listings are in two parts. There medically improved so that you no Program Savings
are listings for adults (part A) and for longer meet or medically equal the prior
1. Title II
children (part B). If you are an listing, we evaluate your case further to
individual age 18 or over, we apply the determine whether you are currently We estimate that these final rules
listings in part A when we assess your disabled. We may find that you are would result in reduced program
claim, and we never use the listings in currently disabled, depending on the outlays resulting in the following
part B. full circumstances of your case. See savings (in millions of dollars) to the
If you are an individual under age 18, §§ 404.1594(c)(3)(i) and title II program ($132 million total in a
we first use the criteria in part B of the 416.994(b)(2)(iv)(A). If you are a child 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.
2. Title XVI resulting in the following savings (in ($25 million in a 5-year period
We estimate that these final rules will millions of dollars) to the SSI program beginning in FY 2008).
result in reduced program outlays
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 PART 404—FEDERAL OLD-AGE, the proper one to support the evaluation and
SURVIVORS AND DISABILITY diagnosis of the disorder. The findings
We certify that these final rules will INSURANCE (1950–) required by these listings must occur within
not have a significant economic impact the period we are considering in connection
on a substantial number of small entities ■ 1. The authority citation for subpart P with your application or continuing
because they affect only individuals. of part 404 continues to read as follows: disability review.
C. How do we consider the effects of
Thus, a regulatory flexibility analysis as Authority: Secs. 202, 205(a), (b), and (d)– treatment?
provided in the Regulatory Flexibility (h), 216(i), 221(a) and (i), 222(c), 223, 225, 1. Digestive disorders frequently respond
Act, as amended, is not required. and 702(a)(5) of the Social Security Act (42 to medical or surgical treatment; therefore,
U.S.C. 402, 405(a), (b), and (d)–(h), 416(i), we generally consider the severity and
Paperwork Reduction Act 421(a) and (i), 422(c), 423, 425, and duration of these disorders within the
902(a)(5)); sec. 211(b), Pub. L. 104–193, 110 context of prescribed treatment.
The Paperwork Reduction Act (PRA) Stat. 2105, 2189; sec. 202, Pub. L. 108–203, 2. We assess the effects of treatment,
of 1995 says that no persons are 118 Stat. 509 (42 U.S.C. 902 note). including medication, therapy, surgery, or
required to respond to a collection of any other form of treatment you receive, by
information unless it displays a valid Appendix 1 to Subpart P of Part 404— determining if there are improvements in the
OMB control number. In accordance Listing of Impairments [Amended] symptoms, signs, and laboratory findings of
with the PRA, SSA is providing notice your digestive disorder. We also assess any
■ 2. Revise item 6 of the introductory side effects of your treatment that may
that OMB has approved the information text before part A of appendix 1 to further limit your functioning.
collection requirements contained in subpart P of part 404 to read as follows: 3. To assess the effects of your treatment,
Part A, 5.00 and Part B, 105.00 of these we may need information about:
final rules. The OMB Control Number Appendix 1 to Subpart P of Part 404—
a. The treatment you have been prescribed
for this collection is 0960–0642 expiring Listing of Impairments (for example, the type of medication or
March 31, 2008. * * * * * therapy, or your use of parenteral
6. Digestive System (5.00 and 105.00): (intravenous) nutrition or supplemental
(Catalog of Federal Domestic Program Nos.
October 19, 2012. enteral nutrition via a gastrostomy);
96.001, Social Security—Disability b. The dosage, method, and frequency of
Insurance; 96.002, Social Security— * * * * * administration;
Retirement Insurance; 96.004, Social ■ 3. Revise section 5.00 in part A of c. Your response to the treatment;
Security—Survivors Insurance; and 96.006, appendix 1 to subpart P of part 404 to d. Any adverse effects of such treatment;
Supplemental Security Income) read as follows: and
e. The expected duration of the treatment.
List of Subjects Appendix 1 to Subpart P of Part 404— 4. Because the effects of treatment may be
Listing of Impairments temporary or long-term, in most cases we
20 CFR Part 404 need information about the impact of your
* * * * *
treatment, including its expected duration
Administrative practice and Part A and side effects, over a sufficient period of
procedure, Death benefits, Blind, time to help us assess its outcome. When
* * * * *
Disability benefits, Old-age, survivors, adverse effects of treatment contribute to the
and disability insurance, Reporting and 5.00 DIGESTIVE SYSTEM
severity of your impairment(s), we will
recordkeeping requirements, Social A. What kinds of disorders do we consider consider the duration or expected duration of
Security. in the digestive system? Disorders of the the treatment when we assess the duration of
digestive system include gastrointestinal your impairment(s).
20 CFR Part 416 hemorrhage, hepatic (liver) dysfunction, 5. If you need parenteral (intravenous)
inflammatory bowel disease, short bowel nutrition or supplemental enteral nutrition
Administrative practice and syndrome, and malnutrition. They may also via a gastrostomy to avoid debilitating
procedure, Aged, Blind, Disability lead to complications, such as obstruction, or complications of a digestive disorder, this
benefits, Public assistance programs, be accompanied by manifestations in other treatment will not, in itself, indicate that you
Reporting and recordkeeping body systems. are unable to do any gainful activity, except
requirements, Supplemental Security B. What documentation do we need? We under 5.07, short bowel syndrome (see
need a record of your medical evidence, 5.00F).
Income (SSI).
including clinical and laboratory findings. 6. If you have not received ongoing
Dated: June 25, 2007. The documentation should include treatment or have not had an ongoing
Michael J. Astrue, appropriate medically acceptable imaging relationship with the medical community
studies and reports of endoscopy, operations, despite the existence of a severe
Commissioner of Social Security. and pathology, as appropriate to each listing, impairment(s), we will evaluate the severity
■ For the reasons set forth in the to document the severity and duration of and duration of your digestive impairment on
your digestive disorder. Medically acceptable the basis of the current medical and other
preamble, subpart P of part 404 and imaging includes, but is not limited to, x-ray evidence in your case record. If you have not
subpart I of part 416 of chapter III of imaging, sonography, computerized axial received treatment, you may not be able to
title 20 of the Code of Federal tomography (CAT scan), magnetic resonance show an impairment that meets the criteria
Regulations are amended as set forth imaging (MRI), and radionuclide scans. of one of the digestive system listings, but
below: Appropriate means that the technique used is your digestive impairment may medically
equal a listing or be disabling based on 4. Chronic viral hepatitis infections. obtaining a sustained viral response (SVR).
consideration of your residual functional a. General. Otherwise, treatment is usually continued for
capacity, age, education, and work (i) Chronic viral hepatitis infections are a total of 48 weeks.
experience. commonly caused by hepatitis C virus (HCV), (ii) Combined interferon and ribavirin
D. How do we evaluate chronic liver and to a lesser extent, hepatitis B virus treatment may have significant adverse
disease? (HBV). Usually, these are slowly progressive effects that may require dosing reduction,
1. General. Chronic liver disease is disorders that persist over many years during planned interruption of treatment, or
characterized by liver cell necrosis, which the symptoms and signs are typically discontinuation of treatment. Adverse effects
inflammation, or scarring (fibrosis or nonspecific, intermittent, and mild (for may include: Anemia (ribavirin-induced
cirrhosis), due to any cause, that persists for example, fatigue, difficulty with hemolysis), neutropenia, thrombocytopenia,
more than 6 months. Chronic liver disease concentration, or right upper quadrant pain). fever, cough, fatigue, myalgia, arthralgia,
may result in portal hypertension, cholestasis Laboratory findings (liver enzymes, imaging nausea, loss of appetite, pruritis, and
(suppression of bile flow), extrahepatic studies, liver biopsy pathology) and insomnia. Behavioral side effects may also
manifestations, or liver cancer. (We evaluate complications are generally similar in HCV occur. Influenza-like symptoms are generally
liver cancer under 13.19.) Significant loss of and HBV. The spectrum of these chronic worse in the first 4 to 6 hours after each
liver function may be manifested by viral hepatitis infections ranges widely and interferon injection and during the first
hemorrhage from varices or portal includes an asymptomatic state; insidious weeks of treatment. Adverse effects generally
hypertensive gastropathy, ascites disease with mild to moderate symptoms end within a few days after treatment is
(accumulation of fluid in the abdominal associated with fluctuating liver tests; discontinued.
cavity), hydrothorax (ascitic fluid in the chest extrahepatic manifestations; cirrhosis, both d. Extrahepatic manifestations of HBV and
cavity), or encephalopathy. There can also be compensated and decompensated; ESLD with HCV. In addition to their hepatic
progressive deterioration of laboratory the need for liver transplantation; and liver manifestations, both HBV and HCV may have
findings that are indicative of liver cancer. Treatment for chronic viral hepatitis significant extrahepatic manifestations in a
dysfunction. Liver transplantation is the only infections varies considerably based on variety of body systems. These include, but
definitive cure for end stage liver disease medication tolerance, treatment response, are not limited to: Keratoconjunctivitis (sicca
(ESLD). adverse effects of treatment, and duration of syndrome), glomerulonephritis, skin
2. Examples of chronic liver disease the treatment. Comorbid disorders, such as disorders (for example, lichen planus,
include, but are not limited to, chronic HIV infection, may affect the clinical course porphyria cutanea tarda), neuropathy, and
hepatitis, alcoholic liver disease, non- of viral hepatitis infection(s) or may alter the immune dysfunction (for example,
alcoholic steatohepatitis (NASH), primary response to medical treatment. cryoglobulinemia, Sjögren’s syndrome, and
biliary cirrhosis (PBC), primary sclerosing (ii) We evaluate all types of chronic viral vasculitis). The extrahepatic manifestations
cholangitis (PSC), autoimmune hepatitis, hepatitis infections under 5.05 or any listing of HBV and HCV may not correlate with the
hemochromatosis, drug-induced liver in an affected body system(s). If your severity of your hepatic impairment. If your
disease, Wilson’s disease, and serum alpha- impairment(s) does not meet or medically impairment(s) does not meet or medically
1 antitrypsin deficiency. Acute hepatic injury equal a listing, we will consider the effects equal a listing in an affected body system(s),
is frequently reversible, as in viral, drug- of your hepatitis when we assess your we will consider the effects of your
induced, toxin-induced, alcoholic, and residual functional capacity. extrahepatic manifestations when we assess
ischemic hepatitis. In the absence of b. Chronic hepatitis B virus (HBV) your residual functional capacity.
evidence of a chronic impairment, episodes infection. 5. Gastrointestinal hemorrhage (5.02 and
of acute liver disease do not meet 5.05. (i) Chronic HBV infection is diagnosed by 5.05A). Gastrointestinal hemorrhaging can
3. Manifestations of chronic liver disease. the detection of hepatitis B surface antigen result in hematemesis (vomiting of blood),
a. Symptoms may include, but are not (HBsAg) in the blood for at least 6 months. melena (tarry stools), or hematochezia
limited to, pruritis (itching), fatigue, nausea, In addition, detection of the hepatitis B (bloody stools). Under 5.02, the required
loss of appetite, or sleep disturbances. envelope antigen (HBeAg) suggests an transfusions of at least 2 units of blood must
Symptoms of chronic liver disease may have increased likelihood of progression to be at least 30 days apart and occur at least
a poor correlation with the severity of liver cirrhosis and ESLD. three times during a consecutive 6-month
disease and functional ability. (ii) The therapeutic goal of treatment is to period. Under 5.05A, hemodynamic
b. Signs may include, but are not limited suppress HBV replication and thereby instability is diagnosed with signs such as
to, jaundice, enlargement of the liver and prevent progression to cirrhosis and ESLD. pallor (pale skin), diaphoresis (profuse
spleen, ascites, peripheral edema, and altered Treatment usually includes a combination of perspiration), rapid pulse, low blood
mental status. interferon injections and oral antiviral agents. pressure, postural hypotension (pronounced
c. Laboratory findings may include, but are Common adverse effects of treatment are the fall in blood pressure when arising to an
not limited to, increased liver enzymes, same as noted in 5.00D4c(ii) for HCV, and upright position from lying down) or syncope
increased serum total bilirubin, increased generally end within a few days after (fainting). Hemorrhaging that results in
ammonia levels, decreased serum albumin, treatment is discontinued. hemodynamic instability is potentially life-
and abnormal coagulation studies, such as c. Chronic hepatitis C virus (HCV) threatening and therefore requires
increased International Normalized Ratio infection. hospitalization for transfusion and
(INR) or decreased platelet counts. (i) Chronic HCV infection is diagnosed by supportive care. Under 5.05A, we require
Abnormally low serum albumin or elevated the detection of hepatitis C viral RNA in the only one hospitalization for transfusion of at
INR levels indicate loss of synthetic liver blood for at least 6 months. Documentation least 2 units of blood.
function, with increased likelihood of of the therapeutic response to treatment is 6. Ascites or hydrothorax (5.05B) indicates
cirrhosis and associated complications. also monitored by the quantitative assay of significant loss of liver function due to
However, other abnormal lab tests, such as serum HCV RNA (‘‘HCV viral load’’). chronic liver disease. We evaluate ascites or
liver enzymes, serum total bilirubin, or Treatment usually includes a combination of hydrothorax that is not attributable to other
ammonia levels, may have a poor correlation interferon injections and oral ribavirin; causes under 5.05B. The required findings
with the severity of liver disease and whether a therapeutic response has occurred must be present on at least two evaluations
functional ability. A liver biopsy may is usually assessed after 12 weeks of at least 60 days apart within a consecutive 6-
demonstrate the degree of liver cell necrosis, treatment by checking the HCV viral load. If month period and despite continuing
inflammation, fibrosis, and cirrhosis. If you there has been a substantial reduction in treatment as prescribed.
have had a liver biopsy, we will make every HCV viral load (also known as early viral 7. Spontaneous bacterial peritonitis (5.05C)
reasonable effort to obtain the results; response, or EVR), this reduction is is an infectious complication of chronic liver
however, we will not purchase a liver biopsy. predictive of a sustained viral response with disease. It is diagnosed by ascitic peritoneal
Imaging studies (CAT scan, ultrasound, MRI) completion of treatment. Combined therapy fluid that is documented to contain an
may show the size and consistency (fatty is commonly discontinued after 12 weeks absolute neutrophil count of at least 250
liver, scarring) of the liver and document when there is no early viral response, since cells/mm3. The required finding in 5.05C is
ascites (see 5.00D6). in that circumstance there is little chance of satisfied with one evaluation documenting
peritoneal fluid infection. We do not evaluate 11. End stage liver disease (ESLD) from the date of the transplantation.
other causes of peritonitis that are unrelated documented by scores from the SSA Chronic Thereafter, we will evaluate your residual
to chronic liver disease, such as tuberculosis, Liver Disease (SSA CLD) calculation (5.05G). impairment(s) by considering the adequacy
malignancy, and perforated bowel, under this a. We will use the SSA CLD score to of post-transplant liver function, the
listing. We evaluate these other causes of evaluate your ESLD under 5.05G. We explain requirement for post-transplant antiviral
peritonitis under the appropriate body how we calculate the SSA CLD score in b. therapy, the frequency and severity of
system listings. through g. of this section. rejection episodes, comorbid complications,
8. Hepatorenal syndrome (5.05D) is b. To calculate the SSA CLD score, we use and all adverse treatment effects.
defined as functional renal failure associated a formula that includes three laboratory E. How do we evaluate inflammatory bowel
with chronic liver disease in the absence of values: Serum total bilirubin (mg/dL), serum disease (IBD)?
underlying kidney pathology. Hepatorenal creatinine (mg/dL), and International 1. Inflammatory bowel disease (5.06)
syndrome is documented by elevation of Normalized Ratio (INR). The formula for the includes, but is not limited to, Crohn’s
serum creatinine, marked sodium retention, SSA CLD score calculation is: disease and ulcerative colitis. These
and oliguria (reduced urine output). The 9.57 × [Loge(serum creatinine mg/dL)] disorders, while distinct entities, share many
requirements of 5.05D are satisfied with +3.78 × [Loge(serum total bilirubin mg/dL)] clinical, laboratory, and imaging findings, as
documentation of any one of the three +11.2 × [Loge(INR)] well as similar treatment regimens.
laboratory findings on one evaluation. We do +6.43 Remissions and exacerbations of variable
not evaluate known causes of renal duration are the hallmark of IBD. Crohn’s
c. When we indicate ‘‘Loge’’ in the formula
dysfunction, such as glomerulonephritis, disease may involve the entire alimentary
for the SSA CLD score calculation, we mean
tubular necrosis, drug-induced renal disease, tract from the mouth to the anus in a
the ‘‘base e logarithm’’ or ‘‘natural logarithm’’
and renal infections, under this listing. We segmental, asymmetric fashion. Obstruction,
(ln) of a numerical laboratory value, not the
evaluate these other renal impairments under stenosis, fistulization, perineal involvement,
‘‘base 10 logarithm’’ or ‘‘common logarithm’’
6.00ff. and extraintestinal manifestations are
(log) of the laboratory value, and not the
9. Hepatopulmonary syndrome (5.05E) is common. Crohn’s disease is rarely curable
actual laboratory value. For example, if an
defined as arterial deoxygenation and recurrence may be a lifelong problem,
individual has laboratory values of serum
(hypoxemia) that is associated with chronic even after surgical resection. In contrast,
creatinine 1.2 mg/dL, serum total bilirubin
liver disease due to intrapulmonary ulcerative colitis only affects the colon. The
2.2 mg/dL, and INR 1.0, we would compute
arteriovenous shunting and vasodilatation in inflammatory process may be limited to the
the SSA CLD score as follows:
the absence of other causes of arterial rectum, extend proximally to include any
deoxygenation. Clinical manifestations 9.57 × [Loge(serum creatinine 1.2 mg/dL) = contiguous segment, or involve the entire
usually include dyspnea, orthodeoxia 0.182] colon. Ulcerative colitis may be cured by
(increasing hypoxemia with erect position), +3.78 × [Loge(serum total bilirubin 2.2 mg/ total colectomy.
platypnea (improvement of dyspnea with flat dL) = 0.788] 2. Symptoms and signs of IBD include
position), cyanosis, and clubbing. The +11.2 × [Loge(INR 1.0) = 0] diarrhea, fecal incontinence, rectal bleeding,
requirements of 5.05E are satisfied with +6.43 abdominal pain, fatigue, fever, nausea,
documentation of any one of the findings on lll vomiting, arthralgia, abdominal tenderness,
one evaluation. In 5.05E1, we require = 1.74 + 2.98 + 0 + 6.43 palpable abdominal mass (usually inflamed
documentation of the altitude of the testing = 11.15, which is then rounded to an SSA loops of bowel) and perineal disease. You
facility because altitude affects the CLD score of 11. may also have signs or laboratory findings
measurement of arterial oxygenation. We will d. For any SSA CLD score calculation, all indicating malnutrition, such as weight loss,
not purchase the specialized studies of the required laboratory values must have edema, anemia, hypoalbuminemia,
described in 5.05E2; however, if you have been obtained within 30 days of each other. hypokalemia, hypocalcemia, or
had these studies at a time relevant to your If there are multiple laboratory values within hypomagnesemia.
claim, we will make every reasonable effort the 30-day interval for any given laboratory 3. IBD may be associated with significant
to obtain the reports for the purpose of test (serum total bilirubin, serum creatinine, extraintestinal manifestations in a variety of
establishing whether your impairment meets or INR), we will use the highest value for the body systems. These include, but are not
5.05E2. SSA CLD score calculation. We will round all limited to, involvement of the eye (for
10. Hepatic encephalopathy (5.05F). laboratory values less than 1.0 up to 1.0. example, uveitis, episcleritis, iritis);
a. General. Hepatic encephalopathy e. Listing 5.05G requires two SSA CLD hepatobiliary disease (for example,
usually indicates severe loss of scores. The laboratory values for the second gallstones, primary sclerosing cholangitis);
hepatocellular function. We define hepatic SSA CLD score calculation must have been urologic disease (for example, kidney stones,
encephalopathy under 5.05F as a recurrent or obtained at least 60 days after the latest obstructive hydronephrosis); skin
chronic neuropsychiatric disorder, laboratory value for the first SSA CLD score involvement (for example, erythema
characterized by abnormal behavior, and within the required 6-month period. We nodosum, pyoderma gangrenosum); or non-
cognitive dysfunction, altered state of will consider the date of each SSA CLD score destructive inflammatory arthritis. You may
consciousness, and ultimately coma and to be the date of the first laboratory value also have associated thromboembolic
death. The diagnosis is established by used for its calculation. disorders or vascular disease. These
changes in mental status associated with f. If you are in renal failure or on dialysis manifestations may not correlate with the
fleeting neurological signs, including within a week of any serum creatinine test severity of your IBD. If your impairment does
‘‘flapping tremor’’ (asterixis), characteristic in the period used for the SSA CLD not meet any of the criteria of 5.06, we will
electroencephalographic (EEG) abnormalities, calculation, we will use a serum creatinine consider the effects of your extraintestinal
or abnormal laboratory values that indicate of 4, which is the maximum serum creatinine manifestations in determining whether you
loss of synthetic liver function. We will not level allowed in the calculation, to calculate have an impairment(s) that meets or
purchase the EEG testing described in your SSA CLD score. medically equals another listing, and we will
5.05F3b; however, if you have had this test g. If you have the two SSA CLD scores also consider the effects of your
at a time relevant to your claim, we will required by 5.05G, we will find that your extraintestinal manifestations when we
make every reasonable effort to obtain the impairment meets the criteria of the listing assess your residual functional capacity.
report for the purpose of establishing from at least the date of the first SSA CLD 4. Surgical diversion of the intestinal tract,
whether your impairment meets 5.05F. score. including ileostomy and colostomy, does not
b. Acute encephalopathy. We will not 12. Liver transplantation (5.09) may be preclude any gainful activity if you are able
evaluate your acute encephalopathy under performed for metabolic liver disease, to maintain adequate nutrition and function
5.05F if it results from conditions other than progressive liver failure, life-threatening of the stoma. However, if you are not able to
chronic liver disease, such as vascular events complications of liver disease, hepatic maintain adequate nutrition, we will evaluate
and neoplastic diseases. We will evaluate malignancy, and acute fulminant hepatitis your impairment under 5.08.
these other causes of acute encephalopathy (viral, drug-induced, or toxin-induced). We F. How do we evaluate short bowel
under the appropriate body system listings. will consider you to be disabled for 1 year syndrome (SBS)?
1. Short bowel syndrome (5.07) is a requirements. Long-term complications of G. How do we evaluate weight loss due to
disorder that occurs when ischemic vascular SBS and parenteral nutrition include central any digestive disorder?
insults (for example, volvulus), trauma, or line infections (with or without septicemia), 1. In addition to the impairments
IBD complications require surgical resection thrombosis, hepatotoxicity, gallstones, and specifically mentioned in these listings, other
of more than one-half of the small intestine, loss of venous access sites. Intestinal digestive disorders, such as esophageal
resulting in the loss of intestinal absorptive transplantation is the only definitive stricture, pancreatic insufficiency, and
surface and a state of chronic malnutrition. treatment for individuals with SBS who malabsorption, may result in significant
The management of SBS requires long-term remain chronically dependent on parenteral weight loss. We evaluate weight loss due to
parenteral nutrition via an indwelling central nutrition. any digestive disorder under 5.08 by using
venous catheter (central line); the process is the Body Mass Index (BMI). We also provide
3. To document SBS, we need a copy of the
often referred to as hyperalimentation or total a criterion in 5.06B for lesser weight loss
operative report of intestinal resection, the
parenteral nutrition (TPN). Individuals with resulting from IBD.
summary of the hospitalization(s) including:
SBS can also feed orally, with variable 2. BMI is the ratio of your weight to the
amounts of nutrients being absorbed through Details of the surgical findings, medically square of your height. Calculation and
their remaining intestine. Over time, some of appropriate postoperative imaging studies interpretation of the BMI are independent of
these individuals can develop additional that reflect the amount of your residual small gender in adults.
intestinal absorptive surface, and may intestine, or if we cannot get one of these a. We calculate BMI using inches and
ultimately be able to be weaned off their reports, other medical reports that include pounds, meters and kilograms, or centimeters
parenteral nutrition. details of the surgical findings. We also need and kilograms. We must have measurements
2. Your impairment will continue to meet medical documentation that you are of your weight and height without shoes for
5.07 as long as you remain dependent on dependent on daily parenteral nutrition to these calculations.
daily parenteral nutrition via a central provide most of your nutritional b. We calculate BMI using one of the
venous catheter for most of your nutritional requirements. following formulas:
English Formula
 Weight in Pounds 
BMI =   × 703
 ( Height in Inches ) × ( Height in Inches ) 
Metric Formula
Weight in Kilograms
BMI =
( Height in Meters ) × ( Height in Meters )
Or
 Weight in Kilograms 
BMI =   × 10, 000
 ( Height in Centimeters ) × ( Height in Centimeters ) 
H. What do we mean by the phrase severe enough to prevent you from doing any 5.01 Category of Impairments, Digestive
‘‘consider under a disability for 1 year’’? We gainful activity. If your impairment(s) does System
use the phrase ‘‘consider under a disability not meet the criteria of any of these listings, 5.02 Gastrointestinal hemorrhaging from
for 1 year’’ following a specific event in 5.02, we must also consider whether you have an any cause, requiring blood transfusion (with
5.05A, and 5.09 to explain how long your impairment(s) that satisfies the criteria of a or without hospitalization) of at least 2 units
impairment can meet the requirements of listing in another body system. For example, of blood per transfusion, and occurring at
those particular listings. This phrase does not if you have hepatitis B or C and you are least three times during a consecutive 6-
refer to the date on which your disability depressed, we will evaluate your impairment month period. The transfusions must be at
began, only to the date on which we must under 12.04. least 30 days apart within the 6-month
reevaluate whether your impairment 2. If you have a severe medically period. Consider under a disability for 1 year
continues to meet a listing or is otherwise determinable impairment(s) that does not following the last documented transfusion;
disabling. For example, if you have received meet a listing, we will determine whether thereafter, evaluate the residual
a liver transplant, you may have become your impairment(s) medically equals a impairment(s).
ER19OC07.005</MATH>
disabled before the transplant because of listing. (See §§ 404.1526 and 416.926.) If your 5.03 [Reserved]
chronic liver disease. Therefore, we do not impairment(s) does not meet or medically 5.04 [Reserved]
restrict our determination of the onset of equal a listing, you may or may not have the 5.05 Chronic liver disease, with:
disability to the date of the specified event. residual functional capacity to engage in A. Hemorrhaging from esophageal, gastric,
We will establish an onset date earlier than substantial gainful activity. In this situation, or ectopic varices or from portal hypertensive
ER19OC07.004</MATH>
the date of the specified event if the evidence we will proceed to the fourth, and if gastropathy, demonstrated by endoscopy, x-
in your case record supports such a finding. necessary, the fifth steps of the sequential ray, or other appropriate medically
I. How do we evaluate impairments that do evaluation process in §§ 404.1520 and acceptable imaging, resulting in
not meet one of the digestive disorder 416.920. When we decide whether you hemodynamic instability as defined in
listings? continue to be disabled, we use the rules in 5.00D5, and requiring hospitalization for
1. These listings are only examples of §§ 404.1594, 416.994, and 416.994a as transfusion of at least 2 units of blood.
ER19OC07.003</MATH>
common digestive disorders that we consider appropriate. Consider under a disability for 1 year
following the last documented transfusion; in 5.00D11. Consider under a disability from 4. Persistent anorexia with weight loss
thereafter, evaluate the residual at least the date of the first score. determined by body mass index (BMI) of less
impairment(s). 5.06 Inflammatory bowel disease (IBD) than 18.0, calculated on at least two
OR documented by endoscopy, biopsy, evaluations at least 30 days apart within a
appropriate medically acceptable imaging, or consecutive 6-month period (see 5.00G2).
B. Ascites or hydrothorax not attributable
operative findings with: * * * * *
to other causes, despite continuing treatment A. Obstruction of stenotic areas (not
as prescribed, present on at least two adhesions) in the small intestine or colon ■ 5. Revise listing 12.09G in part A of
evaluations at least 60 days apart within a with proximal dilatation, confirmed by appendix 1 to subpart P of part 404 to
consecutive 6-month period. Each evaluation appropriate medically acceptable imaging or read as follows:
must be documented by: in surgery, requiring hospitalization for
1. Paracentesis or thoracentesis; or Appendix 1 to Subpart P of Part 404—Listing
intestinal decompression or for surgery, and
2. Appropriate medically acceptable of Impairments
occurring on at least two occasions at least
imaging or physical examination and one of 60 days apart within a consecutive 6-month * * * * *
the following: period; Part A
a. Serum albumin of 3.0 g/dL or less; or
OR * * * * *
b. International Normalized Ratio (INR) of
at least 1.5. B. Two of the following despite continuing 12.09 * * *
treatment as prescribed and occurring within
OR * * * * *
the same consecutive 6-month period:
C. Spontaneous bacterial peritonitis with G. Gastritis. Evaluate under 5.00.
1. Anemia with hemoglobin of less than
peritoneal fluid containing an absolute 10.0 g/dL, present on at least two evaluations * * * * *
neutrophil count of at least 250 cells/mm3. at least 60 days apart; or ■ 6. Revise section 105.00 in part B of
OR 2. Serum albumin of 3.0 g/dL or less, appendix 1 to subpart P of part 404 to
D. Hepatorenal syndrome as described in present on at least two evaluations at least 60 read as follows:
5.00D8, with one of the following: days apart; or
1. Serum creatinine elevation of at least 2 3. Clinically documented tender abdominal Appendix 1 to Subpart P of Part 404—Listing
mg/dL; or mass palpable on physical examination with of Impairments
2. Oliguria with 24-hour urine output less abdominal pain or cramping that is not * * * * *
than 500 mL; or completely controlled by prescribed narcotic
medication, present on at least two Part B
3. Sodium retention with urine sodium less
than 10 mEq per liter. evaluations at least 60 days apart; or * * * * *
4. Perineal disease with a draining abscess 105.00 DIGESTIVE SYSTEM
OR or fistula, with pain that is not completely
E. Hepatopulmonary syndrome as controlled by prescribed narcotic medication, A. What kinds of disorders do we consider
described in 5.00D9, with: present on at least two evaluations at least 60 in the digestive system? Disorders of the
1. Arterial oxygenation (PaO2) on room air days apart; or digestive system include gastrointestinal
of: 5. Involuntary weight loss of at least 10 hemorrhage, hepatic (liver) dysfunction,
a. 60 mm Hg or less, at test sites less than percent from baseline, as computed in inflammatory bowel disease, short bowel
3000 feet above sea level, or pounds, kilograms, or BMI, present on at syndrome, and malnutrition. They may also
b. 55 mm Hg or less, at test sites from 3000 least two evaluations at least 60 days apart; lead to complications, such as obstruction, or
to 6000 feet, or or be accompanied by manifestations in other
c. 50 mm Hg or less, at test sites above 6. Need for supplemental daily enteral body systems. Congenital abnormalities
6000 feet; or nutrition via a gastrostomy or daily involving the organs of the gastrointestinal
2. Documentation of intrapulmonary parenteral nutrition via a central venous system may interfere with the ability to
arteriovenous shunting by contrast-enhanced catheter. maintain adequate nutrition, growth, and
echocardiography or macroaggregated 5.07 Short bowel syndrome (SBS), due to development.
albumin lung perfusion scan. surgical resection of more than one-half of B. What documentation do we need? We
OR the small intestine, with dependence on need a record of your medical evidence,
daily parenteral nutrition via a central including clinical and laboratory findings.
F. Hepatic encephalopathy as described in
venous catheter (see 5.00F). The documentation should include
5.00D10, with 1 and either 2 or 3:
5.08 Weight loss due to any digestive appropriate medically acceptable imaging
1. Documentation of abnormal behavior,
disorder despite continuing treatment as studies and reports of endoscopy, operations,
cognitive dysfunction, changes in mental
prescribed, with BMI of less than 17.50 and pathology, as appropriate to each listing,
status, or altered state of consciousness (for
calculated on at least two evaluations at least to document the severity and duration of
example, confusion, delirium, stupor, or
60 days apart within a consecutive 6-month your digestive disorder. We may also need
coma), present on at least two evaluations at
period. assessments of your growth and
least 60 days apart within a consecutive 6-
5.09 Liver transplantation. Consider development. Medically acceptable imaging
month period; and
under a disability for 1 year following the includes, but is not limited to, x-ray imaging,
2. History of transjugular intrahepatic
date of transplantation; thereafter, evaluate sonography, computerized axial tomography
portosystemic shunt (TIPS) or any surgical
the residual impairment(s) (see 5.00D12 and (CAT scan), magnetic resonance imaging
portosystemic shunt: or
5.00H). (MRI), and radionuclide scans. Appropriate
3. One of the following occurring on at means that the technique used is the proper
least two evaluations at least 60 days apart * * * * * one to support the evaluation and diagnosis
within the same consecutive 6-month period ■ 4. Revise listing 6.02C4 in part A of of the disorder. The findings required by
as in F1: appendix 1 to subpart P of part 404 to these listings must occur within the period
a. Asterixis or other fluctuating physical
read as follows: we are considering in connection with your
neurological abnormalities; or application or continuing disability review.
b. Electroencephalogram (EEG) Appendix 1 to Subpart P of Part 404—Listing C. How do we consider the effects of
demonstrating triphasic slow wave activity; of Impairments treatment?
or * * * * * 1. Digestive disorders frequently respond
c. Serum albumin of 3.0 g/dL or less; or to medical or surgical treatment; therefore,
d. International Normalized Ratio (INR) of Part A

we generally consider the severity and
1.5 or greater. * * * * * duration of these disorders within the
OR 6.02 * * * context of the prescribed treatment.
G. End stage liver disease with SSA CLD * * * * * 2. We assess the effects of treatment,
scores of 22 or greater calculated as described C. * * * including medication, therapy, surgery, or
any other form of treatment you receive, by 2. Examples of chronic liver disease compensated and decompensated; ESLD with
determining if there are improvements in the include, but are not limited to, biliary atresia, the need for liver transplantation; and liver
symptoms, signs, and laboratory findings of chronic hepatitis, non-alcoholic cancer. Treatment for chronic viral hepatitis
your digestive disorder. We also assess any steatohepatitis (NASH), primary biliary infections varies considerably based on age,
side effects of your treatment that may cirrhosis (PBC), primary sclerosing medication tolerance, treatment response,
further limit your functioning. cholangitis (PSC), autoimmune hepatitis, adverse effects of treatment, and duration of
3. To assess the effects of your treatment, hemochromatosis, drug-induced liver the treatment. Comorbid disorders, such as
we may need information about: disease, Wilson’s disease, and serum alpha- HIV infection, may affect the clinical course
a. The treatment you have been prescribed 1 antitrypsin deficiency. Children can also of viral hepatitis infection(s) or may alter the
(for example, the type of medication or have congenital abnormalities of abdominal response to medical treatment.
therapy, or your use of parenteral organs or inborn metabolic disorders that (ii) We evaluate all types of chronic viral
(intravenous) nutrition or supplemental result in chronic liver disease. Acute hepatic hepatitis infections under 105.05 or any
enteral nutrition via a gastrostomy); injury is frequently reversible as in viral, listing in an affected body system(s). If your
b. The dosage, method, and frequency of drug-induced, toxin-induced, and ischemic impairment(s) does not meet or medically
administration; hepatitis. In the absence of evidence of a equal a listing, we will consider the effects
c. Your response to the treatment; chronic impairment, episodes of acute liver of your hepatitis when we assess whether
d. Any adverse effects of such treatment; disease do not meet 105.05. your impairment(s) functionally equals the
and 3. Manifestations of chronic liver disease. listings.
e. The expected duration of the treatment. a. Symptoms may include, but are not b. Chronic hepatitis B virus (HBV)
4. Because the effects of treatment may be limited to, pruritis (itching), fatigue, nausea, infection.
temporary or long-term, in most cases we loss of appetite, or sleep disturbances. (i) Chronic HBV infection is diagnosed by
need information about the impact of your Children can also have associated the detection of hepatitis B surface antigen
treatment, including its expected duration developmental delays or poor school (HBsAg) in the blood for at least 6 months.
and side effects, over a sufficient period of performance. Symptoms of chronic liver In addition, detection of the hepatitis B
time to help us assess its outcome. When disease may have a poor correlation with the envelope antigen (HBeAg) suggests an
adverse effects of treatment contribute to the severity of liver disease and functional increased likelihood of progression to
severity of your impairment(s), we will ability. cirrhosis and ESLD.
consider the duration or expected duration of b. Signs may include, but are not limited (ii) The therapeutic goal of treatment is to
the treatment when we assess the duration of to, jaundice, enlargement of the liver and suppress HBV replication and thereby
your impairment(s). spleen, ascites, peripheral edema, and altered prevent progression to cirrhosis and ESLD.
5. If you need parenteral (intravenous) mental status. Treatment usually includes a combination of
nutrition or supplemental enteral nutrition
c. Laboratory findings may include, but are interferon injections and oral antiviral agents.
via a gastrostomy to avoid debilitating
not limited to, increased liver enzymes, Common adverse effects of treatment are the
complications of a digestive disorder, this
increased serum total bilirubin, increased same as noted in 105.00D4c(ii) for HCV, and
treatment will not, in itself, indicate that you
ammonia levels, decreased serum albumin, generally end within a few days after
have marked and severe functional
and abnormal coagulation studies, such as treatment is discontinued.
limitations. The exceptions are 105.07, short
bowel syndrome, and 105.10, for children increased International Normalized Ratio c. Chronic hepatitis C virus (HCV)
who have not attained age 3 and who require (INR) or decreased platelet counts. infection.
supplemental daily enteral feedings via a Abnormally low serum albumin or elevated (i) Chronic HCV infection is diagnosed by
gastrostomy (see 105.00F and 105.00H). INR levels indicate loss of synthetic liver the detection of hepatitis C viral RNA in the
6. If you have not received ongoing function, with increased likelihood of blood for at least 6 months. Documentation
treatment or have not had an ongoing cirrhosis and associated complications. of the therapeutic response to treatment is
relationship with the medical community However, other abnormal lab tests, such as also monitored by the quantitative assay of
despite the existence of a severe liver enzymes, serum total bilirubin, or serum HCV RNA (‘‘HCV viral load’’).
impairment(s), we will evaluate the severity ammonia levels, may have a poor correlation Treatment usually includes a combination of
and duration of your digestive impairment on with the severity of liver disease and interferon injections and oral ribavirin;
the basis of current medical and other functional ability. A liver biopsy may whether a therapeutic response has occurred
evidence in your case record. If you have not demonstrate the degree of liver cell necrosis, is usually assessed after 12 weeks of
received treatment, you may not be able to inflammation, fibrosis, and cirrhosis. If you treatment by checking the HCV viral load. If
show an impairment that meets the criteria have had a liver biopsy, we will make every there has been a substantial reduction in
of one of the digestive system listings, but reasonable effort to obtain the results; HCV viral load (also known as early viral
your digestive impairment may medically however, we will not purchase a liver biopsy. response, or EVR), this reduction is
equal a listing or functionally equal the Imaging studies (CAT scan, ultrasound, MRI) predictive of a sustained viral response with
listings. may show the size and consistency (fatty completion of treatment. Combined therapy
D. How do we evaluate chronic liver liver, scarring) of the liver and document is commonly discontinued after 12 weeks
disease? ascites (see 105.00D6). when there is no early viral response, since
1. General. Chronic liver disease is 4. Chronic viral hepatitis infections. in that circumstance there is little chance of
characterized by liver cell necrosis, a. General. obtaining a sustained viral response (SVR).
inflammation, or scarring (fibrosis or (i) Chronic viral hepatitis infections are Otherwise, treatment is usually continued for
cirrhosis), due to any cause, that persists for commonly caused by hepatitis C virus (HCV), a total of 48 weeks.
more than 6 months. Chronic liver disease and to a lesser extent, hepatitis B virus (ii) Combined interferon and ribavirin
may result in portal hypertension, cholestasis (HBV). Usually, these are slowly progressive treatment may have significant adverse
(suppression of bile flow), extrahepatic disorders that persist over many years during effects that may require dosing reduction,
manifestations, or liver cancer. (We evaluate which the symptoms and signs are typically planned interruption of treatment, or
liver cancer under 113.03.) Significant loss of nonspecific, intermittent, and mild (for discontinuation of treatment. Adverse effects
liver function may be manifested by example, fatigue, difficulty with may include: Anemia (ribavirin-induced
hemorrhage from varices or portal concentration, or right upper quadrant pain). hemolysis), neutropenia, thrombocytopenia,
hypertensive gastropathy, ascites Laboratory findings (liver enzymes, imaging fever, cough, fatigue, myalgia, arthralgia,
(accumulation of fluid in the abdominal studies, liver biopsy pathology) and nausea, loss of appetite, pruritis, and
cavity), hydrothorax (ascitic fluid in the chest complications are generally similar in HCV insomnia. Behavioral side effects may also
cavity), or encephalopathy. There can also be and HBV. The spectrum of these chronic occur. Influenza-like symptoms are generally
progressive deterioration of laboratory viral hepatitis infections ranges widely and worse in the first 4 to 6 hours after each
findings that are indicative of liver includes an asymptomatic state; insidious interferon injection and during the first
dysfunction. Liver transplantation is the only disease with mild to moderate symptoms weeks of treatment. Adverse effects generally
definitive cure for end stage liver disease associated with fluctuating liver tests; end within a few days after treatment is
(ESLD). extrahepatic manifestations; cirrhosis, both discontinued.
d. Extrahepatic manifestations of HBV and dysfunction, such as glomerulonephritis, 9.57 × [Loge (serum creatinine mg/dL)]
HCV. In addition to their hepatic tubular necrosis, drug-induced renal disease, +3.78 × [Loge (serum total bilirubin mg/dL)]
manifestations, both HBV and HCV may have and renal infections, under this listing. We +11.2 × [Loge (INR)]
significant extrahepatic manifestations in a evaluate these other renal impairments under +6.43
variety of body systems. These include, but 106.00ff. (iii) When we indicate ‘‘Loge’’ in the
are not limited to: Keratoconjunctivitis (sicca 9. Hepatopulmonary syndrome (105.05E) is formula for the SSA CLD score calculation,
syndrome), glomerulonephritis, skin defined as arterial deoxygenation we mean the ‘‘base e logarithm’’ or ‘‘natural
disorders (for example, lichen planus, (hypoxemia) that is associated with chronic logarithm’’ (ln) of a numerical laboratory
porphyria cutanea tarda), neuropathy, and liver disease due to intrapulmonary value, not the ‘‘base 10 logarithm’’ or
immune dysfunction (for example, arteriovenous shunting and vasodilatation, in ‘‘common logarithm’’ (log) of the laboratory
cryoglobulinemia, Sjögren’s syndrome, and the absence of other causes of arterial value, and not the actual laboratory value.
vasculitis). The extrahepatic manifestations deoxygenation. Clinical manifestations For an example of SSA CLD calculation, see
of HBV and HCV may not correlate with the usually include dyspnea, orthodeoxia 5.00D11c.
severity of your hepatic impairment. If your (increasing hypoxemia with erect position), (iv) For any SSA CLD score calculation, all
impairment(s) does not meet or medically platypnea (improvement of dyspnea with flat of the required laboratory values must have
equal a listing in an affected body system(s), position), cyanosis, and clubbing. The been obtained within 30 days of each other.
we will consider the effects of your requirements of 105.05E are satisfied with If there are multiple laboratory values within
extrahepatic manifestations when we documentation of any one of the findings on the 30-day interval for any given laboratory
determine whether your impairment(s) one evaluation. In 105.05E1, we require test (serum total bilirubin, serum creatinine,
functionally equals the listings. documentation of the altitude of the testing or INR), we will use the highest value for the
5. Gastrointestinal hemorrhage (105.02 and facility because altitude affects the SSA CLD score calculation. We will round all
105.05A). Gastrointestinal hemorrhaging can measurement of arterial oxygenation. We will laboratory values less than 1.0 up to 1.0.
result in hematemesis (vomiting of blood), not purchase the specialized studies (v) Listing 105.05G requires two SSA CLD
melena (tarry stools), or hematochezia described in 105.05E2; however, if you have scores. The laboratory values for the second
(bloody stools). Under 105.02, the required had these studies at a time relevant to your SSA CLD score calculation must have been
transfusions of at least 10 cc of blood/kg of claim, we will make every reasonable effort
obtained at least 60 days after the latest
body weight must be at least 30 days apart to obtain the reports for the purpose of
laboratory value for the first SSA CLD score
and occur at least three times during a establishing whether your impairment meets
and within the required 6-month period. We
consecutive 6-month period. Under 105.05A, 105.05E2.
will consider the date of each SSA CLD score
hemodynamic instability is diagnosed with 10. Hepatic encephalopathy (105.05F).
to be the date of the first laboratory value
a. General. Hepatic encephalopathy
signs such as pallor (pale skin), diaphoresis used for its calculation.
usually indicates severe loss of
(profuse perspiration), rapid pulse, low blood (vi) If you are in renal failure or on dialysis
hepatocellular function. We define hepatic
pressure, postural hypotension (pronounced within a week of any serum creatinine test
encephalopathy under 105.05F as a recurrent
fall in blood pressure when arising to an in the period used for the SSA CLD
or chronic neuropsychiatric disorder,
upright position from lying down) or syncope calculation, we will use a serum creatinine
characterized by abnormal behavior,
(fainting). Hemorrhaging that results in cognitive dysfunction, altered state of of 4, which is the maximum serum creatinine
hemodynamic instability is potentially life- consciousness, and ultimately coma and level allowed in the calculation, to calculate
threatening and therefore requires death. The diagnosis is established by your SSA CLD score.
hospitalization for transfusion and changes in mental status associated with (vii) If you have the two SSA CLD scores
supportive care. Under 105.05A, we require fleeting neurological signs, including required by 105.05G1, we will find that your
only one hospitalization for transfusion of at ‘‘flapping tremor’’ (asterixis), characteristic impairment meets the criteria of the listing
least 10 cc of blood/kg of body weight. electroencephalographic (EEG) abnormalities, from at least the date of the first SSA CLD
6. Ascites or hydrothorax (105.05B) or abnormal laboratory values that indicate score.
indicates significant loss of liver function loss of synthetic liver function. We will not b. SSA CLD–P score.
due to chronic liver disease. We evaluate purchase the EEG testing described in (i) If you have not attained age 12, we will
ascites or hydrothorax that is not attributable 105.05F3b. However, if you have had this test use the SSA CLD–P score to evaluate your
to other causes under 105.05B. The required at a time relevant to your claim, we will ESLD under 105.05G2. We explain how we
findings must be present on at least two make every reasonable effort to obtain the calculate the SSA CLD–P score in b(ii)
evaluations at least 60 days apart within a report for the purpose of establishing through b(vii) of this section.
consecutive 6-month period and despite whether your impairment meets 105.05F. (ii) To calculate the SSA CLD–P score, we
continuing treatment as prescribed. b. Acute encephalopathy. We will not use a formula that includes four parameters:
7. Spontaneous bacterial peritonitis evaluate your acute encephalopathy under Serum total bilirubin (mg/dL), International
(105.05C) is an infectious complication of 105.05F if it results from conditions other Normalized Ratio (INR), serum albumin (g/
chronic liver disease. It is diagnosed by than chronic liver disease, such as vascular dL), and whether growth failure is occurring.
ascitic peritoneal fluid that is documented to events and neoplastic diseases. We will The formula for the SSA CLD–P score
contain an absolute neutrophil count of at evaluate these other causes of acute calculation is:
least 250 cells/mm 3. The required finding in encephalopathy under the appropriate body 4.80 × [Loge (serum total bilirubin mg/dL)]
105.05C is satisfied with one evaluation system listings. +18.57 × [Loge (INR)]
documenting peritoneal fluid infection. We 11. End stage liver disease (ESLD) ¥6.87 × [Loge (serum albumin g/dL)]
do not evaluate other causes of peritonitis documented by scores from the SSA Chronic +6.67 if the child has growth failure (<¥2
that are unrelated to chronic liver disease, Liver Disease (SSA CLD) calculation standard deviations for weight or height)
such as tuberculosis, malignancy, and (105.05G1) and SSA Chronic Liver Disease- (iii) When we indicate ‘‘Loge’’ in the
perforated bowel, under this listing. We Pediatric (SSA CLD–P) calculation formula for the SSA CLD–P score calculation,
evaluate these other causes of peritonitis (105.05G2). we mean the ‘‘base e logarithm’’ or ‘‘natural
under the appropriate body system listings. a. SSA CLD score. logarithm’’ (ln) of a numerical laboratory
8. Hepatorenal syndrome (105.05D) is (i) If you are age 12 or older, we will use value, not the ‘‘base 10 logarithm’’ or
defined as functional renal failure associated the SSA CLD score to evaluate your ESLD ‘‘common logarithm’’ (log) of the laboratory
with chronic liver disease in the absence of under 105.05G1. We explain how we value, and not the actual laboratory value.
underlying kidney pathology. Hepatorenal calculate the SSA CLD score in a(ii) through For example, if a female child is 4.0 years
syndrome is documented by elevation of a(vii) of this section. old, has a current weight of 13.5 kg (10th
serum creatinine, marked sodium retention, (ii) To calculate the SSA CLD score, we use percentile for age) and height of 92 cm (less
and oliguria (reduced urine output). The a formula that includes three laboratory than the third percentile for age), and has
requirements of 105.05D are satisfied with values: Serum total bilirubin (mg/dL), serum laboratory values of serum total bilirubin 2.2
documentation of any one of the three creatinine (mg/dL), and International mg/dL, INR 1.0, and serum albumin 3.5 g/dL,
laboratory findings on one evaluation. We do Normalized Ratio (INR). The formula for the we will compute the SSA CLD–P score as
not evaluate known causes of renal SSA CLD score calculation is: follows:
4.80 × [Loge +(serum total bilirubin 2.2 mg/ 1. Inflammatory bowel disease (105.06) resulting in the loss of intestinal absorptive
dL) = 0.788] includes, but is not limited to, Crohn’s surface and a state of chronic malnutrition.
+18.57 × [Loge (INR 1.0) = 0] disease and ulcerative colitis. These The management of SBS requires long-term
¥6.87 × [Loge +(serum albumin 3.5 g/dL) = disorders, while distinct entities, share many parenteral nutrition via an indwelling central
1.253] clinical, laboratory, and imaging findings, as venous catheter (central line); the process is
+6.67 well as similar treatment regimens. often referred to as hyperalimentation or total
lll Remissions and exacerbations of variable parenteral nutrition (TPN). Children with
= 3.78 + 0 ¥8.61 + 6.67 duration are the hallmark of IBD. Crohn’s SBS can also feed orally, with variable
= 1.84, which is then rounded to an SSA disease may involve the entire alimentary
amounts of nutrients being absorbed through
CLD–P score of 2 tract from the mouth to the anus in a
their remaining intestine. Over time, some of
(iv) For any SSA CLD–P score calculation, segmental, asymmetric fashion. Obstruction,
stenosis, fistulization, perineal involvement, these children can develop additional
all of the required laboratory values (serum intestinal absorptive surface, and may
total bilirubin, INR, or serum albumin) must and extraintestinal manifestations are
common. Crohn’s disease is rarely curable ultimately be able to be weaned off their
have been obtained within 30 days of each
and recurrence may be a lifelong problem, parenteral nutrition.
other. We will not purchase INR values for
children who have not attained age 12. If even after surgical resection. In contrast, 2. Your impairment will continue to meet
there is no INR value for a child under 12 ulcerative colitis only affects the colon. The 105.07 as long as you remain dependent on
within the applicable time period, we will inflammatory process may be limited to the daily parenteral nutrition via a central
use an INR value of 1.1 to calculate the SSA rectum, extend proximally to include any venous catheter for most of your nutritional
CLD–P score. If there are multiple laboratory contiguous segment, or involve the entire requirements. Long-term complications of
values within the 30-day interval for any colon. Ulcerative colitis may be cured by SBS and parenteral nutrition include
given laboratory test, we will use the highest total colectomy. abnormal growth rates, central line infections
serum total bilirubin and INR values and the 2. Symptoms and signs of IBD include (with or without septicemia), thrombosis,
lowest serum albumin value for the SSA diarrhea, fecal incontinence, rectal bleeding, hepatotoxicity, gallstones, and loss of venous
CLD–P score calculation. We will round all abdominal pain, fatigue, fever, nausea, access sites. Intestinal transplantation is the
laboratory values less than 1.0 up to 1.0. vomiting, arthralgia, abdominal tenderness, only definitive treatment for children with
(v) The weight and length/height palpable abdominal mass (usually inflamed SBS who remain chronically dependent on
measurements used for the calculation must loops of bowel) and perineal disease. You parenteral nutrition.
be obtained from one evaluation within the may also have signs or laboratory findings 3. To document SBS, we need a copy of the
same 30-day period as in D11b(iv). indicating malnutrition, such as weight loss, operative report of intestinal resection, the
(vi) Listing 105.05G2 requires two SSA edema, anemia, hypoalbuminemia, summary of the hospitalization(s) including:
CLD–P scores. The laboratory values for the hypokalemia, hypocalcemia, or
Details of the surgical findings, medically
second SSA CLD–P score calculation must hypomagnesemia.
appropriate postoperative imaging studies
have been obtained at least 60 days after the 3. IBD may be associated with significant
latest laboratory value for the first SSA CLD– extraintestinal manifestations in a variety of that reflect the amount of your residual small
P score and within the required 6-month body systems. These include, but are not intestine, or if we cannot get one of these
period. We will consider the date of each limited to, involvement of the eye (for reports, other medical reports that include
SSA CLD–P score to be the date of the first example, uveitis, episcleritis, iritis); details of the surgical findings. We also need
laboratory value used for its calculation. hepatobiliary disease (for example, medical documentation that you are
(vii) If you have the two SSA CLD–P scores gallstones, primary sclerosing cholangitis); dependent on daily parenteral nutrition to
required by listing 105.05G2, we will find urologic disease (for example, kidney stones, provide most of your nutritional
that your impairment meets the criteria of the obstructive hydronephrosis); skin requirements.
listing from at least the date of the first SSA involvement (for example, erythema G. How do we evaluate malnutrition in
CLD–P score. nodosum, pyoderma gangrenosum); or non- children?
12. Extrahepatic biliary atresia (EBA) destructive inflammatory arthritis. You may 1. Many types of digestive disorders can
(105.05H) usually presents in the first 2 also have associated thromboembolic result in malnutrition and growth
months of life with persistent jaundice. The disorders or vascular disease. These retardation. To meet the malnutrition criteria
impairment meets 105.05H if the diagnosis of manifestations may not correlate with the in 105.08A, we need documentation of a
EBA is confirmed by liver biopsy or severity of your IBD. If your impairment does digestive disorder with associated chronic
intraoperative cholangiogram that shows not meet any of the criteria of 105.06, we will nutritional deficiency despite prescribed
obliteration of the extrahepatic biliary tree. consider the effects of your extraintestinal treatment.
EBA is usually surgically treated by manifestations in determining whether you 2. We evaluate the growth retardation
portoenterostomy (for example, Kasai have an impairment(s) that meets or criteria in 105.08B by using the most recent
procedure). If this surgery is not performed medically equals another listing, and we will growth charts by the Centers for Disease
in the first months of life or is not completely also consider the effects of your Control and Prevention (CDC).
successful, liver transplantation is indicated. extraintestinal manifestations when we a. If you have not attained age 2, we use
If you have had a liver transplant, we will determine whether your impairment(s) weight-for-length measurements to assess
evaluate your impairment under 105.09. functionally equals the listings.
whether your impairment meets the
13. Liver transplantation (105.09) may be 4. Surgical diversion of the intestinal tract,
requirement of 105.08B1. CDC weight-for-
performed for metabolic liver disease, including ileostomy and colostomy, does not
length charts are age- and gender-specific.
progressive liver failure, life-threatening very seriously interfere with age-appropriate
complications of liver disease, hepatic functioning if you are able to maintain b. If you are a child age 2 or older, we use
malignancy, and acute fulminant hepatitis adequate nutrition and function of the stoma. BMI-for-age measurements to assess whether
(viral, drug-induced, or toxin-induced). We However, if you are not able to maintain your impairment meets the requirement of
will consider you to be disabled for 1 year adequate nutrition, we will evaluate your 105.08B2. BMI is the ratio of your weight to
from the date of the transplantation. impairment under 105.08. the square of your height. BMI-for-age is
Thereafter, we will evaluate your residual F. How do we evaluate short bowel plotted on the CDC’s gender-specific growth
impairment(s) by considering the adequacy syndrome (SBS)? charts.
of post-transplant liver function, the 1. Short bowel syndrome (105.07) is a c. We calculate BMI using inches and
requirement for post-transplant antiviral disorder that occurs when congenital pounds, meters and kilograms, or centimeters
therapy, the frequency and severity of intestinal abnormalities, ischemic vascular and kilograms. We must have measurements
rejection episodes, comorbid complications, insults (for example, necrotizing of your weight and height without shoes for
and all adverse treatment effects. enterocolitis, volvulus), trauma, or IBD these calculations.
E. How do we evaluate inflammatory bowel complications require surgical resection of d. We calculate BMI using one of the
disease (IBD)? more than one-half of the small intestine, following formulas:
English Formula
 Weight in Pounds 
BMI =   × 703
 ( Height in Inches ) × ( Height in Inches ) 
Metric Formula
Weight in Kilograms
BMI =
( Height in Meters ) × ( Height in Meters )
Or
 Weight in Kilograms 
BMI =   × 10, 000
 ( Height in Centimeters ) × ( Height in Centimeters ) 
H. How do we evaluate the need for impairment continues to meet a listing or is continue to be disabled, we use the rules in
supplemental daily enteral feeding via a otherwise disabling. For example, if you have § 416.994a.
gastrostomy? received a liver transplant, you may have 105.01 Category of Impairments,
1. General. Infants and young children may become disabled before the transplant Digestive System
have anatomical, neurological, or because of chronic liver disease. Therefore, 105.02 Gastrointestinal hemorrhaging
developmental disorders that interfere with we do not restrict our determination of the from any cause, requiring blood transfusion
their ability to feed by mouth, resulting in onset of disability to the date of the specified (with or without hospitalization) of at least
inadequate caloric intake to meet their event. We will establish an onset date earlier 10 cc of blood/kg of body weight, and
growth needs. These disorders frequently than the date of the specified event if the occurring at least three times during a
result in the medical necessity to supplement evidence in your case record supports such consecutive 6-month period. The
caloric intake and to bypass the anatomical a finding. transfusions must be at least 30 days apart
feeding route of mouth-throat-esophagus into K. How do we evaluate impairments that within the 6-month period. Consider under a
the stomach. do not meet one of the digestive disorder disability for 1 year following the last
2. Children who have not attained age 3 listings? documented transfusion; thereafter, evaluate
and who require supplemental daily enteral 1. These listings are only examples of the residual impairment(s).
nutrition via a feeding gastrostomy meet common digestive disorders that we consider 105.03 [Reserved]
105.10 regardless of the medical reason for severe enough to result in marked and severe 105.04 [Reserved]
the gastrostomy. Thereafter, we evaluate functional limitations. If your impairment(s) 105.05 Chronic liver disease, with:
growth impairment under 100.02, does not meet the criteria of any of these A. Hemorrhaging from esophageal, gastric,
malnutrition under 105.08, or other medical or ectopic varices or from portal hypertensive
listings, we must also consider whether you
or developmental disorder(s) (including the gastropathy, demonstrated by endoscopy, x-
have an impairment(s) that satisfies the
disorder(s) that necessitated gastrostomy ray, or other appropriate medically
criteria of a listing in another body system.
placement) under the appropriate listing(s). acceptable imaging, resulting in
For example:
I. How do we evaluate esophageal stricture hemodynamic instability as defined in
a. If you have hepatitis B or C and you are 105.00D5, and requiring hospitalization for
or stenosis? Esophageal stricture or stenosis
(narrowing) from congenital atresia (absence depressed, we will evaluate your impairment transfusion of at least 10 cc of blood/kg of
or abnormal closure of a tubular body organ) under 112.04. body weight. Consider under a disability for
or destructive esophagitis may result in b. If you have multiple congenital 1 year following the last documented
malnutrition or the need for gastrostomy abnormalities, we will evaluate your transfusion; thereafter, evaluate the residual
placement, which we evaluate under 105.08 impairment(s) under the criteria in the impairment(s).
or 105.10. Esophageal stricture or stenosis listings for impairments that affect multiple
OR
may also result in complications such as body systems (110.00) or the criteria of
listings in other affected body systems. B. Ascites or hydrothorax not attributable
pneumonias due to frequent aspiration, or to other causes, despite continuing treatment
difficulty in maintaining nutritional status c. If you have digestive disorders that
interfere with intake, digestion, or absorption as prescribed, present on at least two
short of listing-level severity. While none of evaluations at least 60 days apart within a
these complications may be of such severity of nutrition, and result in a reduction in your
rate of growth, and your impairment does not consecutive 6-month period. Each evaluation
that they would meet the criteria of another must be documented by:
listing, the combination of impairments may satisfy the criteria in the malnutrition listing
1. Paracentesis or thoracentesis; or
ER19OC07.005</MATH>
medically equal the severity of a listing or (105.08), we will evaluate your impairment
under the growth impairment listings 2. Appropriate medically acceptable
functionally equal the listings. imaging or physical examination and one of
J. What do we mean by the phrase (100.00).
the following:
‘‘consider under a disability for 1 year’’? We 2. If you have a severe medically
a. Serum albumin of 3.0 g/dL or less; or
use the phrase ‘‘consider under a disability determinable impairment(s) that does not
b. International Normalized Ratio (INR) of
for 1 year’’ following a specific event in meet a listing, we will determine whether
ER19OC07.004</MATH>
at least 1.5.
105.02, 105.05A, and 105.09 to explain how your impairment(s) medically equals a
long your impairment can meet the listing. (See § 416.926.) If your impairment(s) OR
requirements of those particular listings. This does not meet or medically equal a listing, C. Spontaneous bacterial peritonitis with
phrase does not refer to the date on which you may or may not have an impairment(s) peritoneal fluid containing an absolute
your disability began, only to the date on that functionally equals the listings. (See neutrophil count of at least 250 cells/mm 3.
ER19OC07.003</MATH>
which we must reevaluate whether your § 416.926a.) When we decide whether you OR
D. Hepatorenal syndrome as described in H. Extrahepatic biliary atresia as diagnosed B. Growth retardation documented by one
105.00D8, with one of the following: on liver biopsy or intraoperative of the following:
1. Serum creatinine elevation of at least 2 cholangiogram. Consider under a disability 1. For children who have not attained age
mg/dL; or for 1 year following the diagnosis; thereafter, 2, multiple weight-for-length measurements
2. Oliguria with 24-hour urine output less evaluate the residual liver function. that are less than the third percentile on the
than 1 mL/kg/hr; or 105.06 Inflammatory bowel disease (IBD) CDC’s most recent weight-for-length growth
3. Sodium retention with urine sodium less documented by endoscopy, biopsy, charts, documented at least three times
than 10 mEq per liter. appropriate medically acceptable imaging, or within a consecutive 6-month period; or
OR operative findings with: 2. For children age 2 and older, multiple
E. Hepatopulmonary syndrome as A. Obstruction of stenotic areas (not Body Mass Index (BMI)-for-age
described in 105.00D9, with: adhesions) in the small intestine or colon measurements that are less than the third
1. Arterial oxygenation (PaO2,) on room air with proximal dilatation, confirmed by percentile on the CDC’s most recent BMI-for-
of: appropriate medically acceptable imaging or age growth charts, documented at least three
a. 60 mm Hg or less, at test sites less than in surgery, requiring hospitalization for times within a consecutive 6-month period.
3000 feet above sea level, or intestinal decompression or for surgery, and
105.09 Liver transplantation. Consider
occurring on at least two occasions at least
b. 55 mm Hg or less, at test sites from 3000 under a disability for 1 year following the
60 days apart within a consecutive 6-month
to 6000 feet, or date of transplantation; thereafter, evaluate
period;
c. 50 mm Hg or less, at test sites above the residual impairment(s) (see 105.00D13
6000 feet; or OR and 105.00J).
2. Documentation of intrapulmonary B. Two of the following despite continuing 105.10 Need for supplemental daily
arteriovenous shunting by contrast-enhanced treatment as prescribed and occurring within enteral feeding via a gastrostomy due to any
echocardiography or macroaggregated the same consecutive 6-month period: cause, for children who have not attained age
albumin lung perfusion scan. 1. Anemia with hemoglobin less than 10.0 3; thereafter, evaluate the residual
OR g/dL, present on at least two evaluations at impairment(s) (see 105.00H).
least 60 days apart; or
F. Hepatic encephalopathy as described in * * * * *
2. Serum albumin of 3.0 g/dL or less,
105.00D10, with 1 and either 2 or 3:
present on at least two evaluations at least 60
1. Documentation of abnormal behavior, PART 416—SUPPLEMENTAL
days apart; or
cognitive dysfunction, changes in mental SECURITY INCOME FOR THE AGED,
3. Clinically documented tender abdominal
status, or altered state of consciousness (for BLIND, AND DISABLED
mass palpable on physical examination with
example, confusion, delirium, stupor, or
abdominal pain or cramping that is not
coma), present on at least two evaluations at Subpart I—[Amended]
completely controlled by prescribed narcotic
least 60 days apart within a consecutive 6-
medication, present on at least two
month period; and
evaluations at least 60 days apart; or ■ 7. Revise the authority citation for
2. History of transjugular intrahepatic
4. Perineal disease with a draining abscess
portosystemic shunt (TIPS) or any surgical
or fistula, with pain that is not completely
subpart I of part 416 to read as follows:
portosystemic shunt; or Authority: Secs. 221(m), 702(a)(5), 1611,
controlled by prescribed narcotic medication,
3. One of the following occurring on at
present on at least two evaluations at least 60 1614, 1619, 1631(a), (c), (d)(1), and (p) and
least two evaluations at least 60 days apart
days apart; or 1633 of the Social Security Act (42 U.S.C.
within the same consecutive 6-month period
5. Need for supplemental daily enteral 421(m), 902(a)(5), 1382, 1382c, 1382h,
as in F1:
nutrition via a gastrostomy or daily 1383(a), (c), (d)(1), and (p), and 1383b); secs.
a. Asterixis or other fluctuating physical
parenteral nutrition via a central venous 4(c) and 5, 6(c)–(e), 14(a), and 15, Pub. L. 98–
neurological abnormalities; or
catheter. (See 105.10 for children who have 460, 98 Stat. 1794, 1801, 1802, and 1808 (42
b. Electroencephalogram (EEG)
not attained age 3.) U.S.C. 421 note, 423 note, and 1382h note).
demonstrating triphasic slow wave activity;
105.07 Short bowel syndrome (SBS), due
or § 416.924b [Amended]
to surgical resection of more than one-half of
c. Serum albumin of 3.0 g/dL or less; or
the small intestine, with dependence on
d. International Normalized Ratio (INR) of ■ 8. In § 416.924b(b)(3), remove the
daily parenteral nutrition via a central
1.5 or greater. reference ‘‘§ 416.924a(m)(7) or (8)’’ and
venous catheter (see 105.00F).
OR 105.08 Malnutrition due to any digestive insert the reference ‘‘§ 416.926a(m)(6) or
G. End Stage Liver Disease, with: disorder with: (7)’’ in its place.
1. For children 12 years of age or older, A. Chronic nutritional deficiency despite
SSA CLD scores of 22 or greater calculated continuing treatment as prescribed, present § 416.926a [Amended]
as described in 105.00D11a. Consider under on at least two evaluations at least 60 days
a disability from at least the date of the first apart within a consecutive 6-month period, ■ 9. In § 416.926a, remove paragraphs
score. and documented by one of the following: (m)(3) and (m)(10) and redesignate
2. For children who have not attained age 1. Anemia with hemoglobin less than 10.0 paragraphs (m)(4), (m)(5), (m)(6), (m)(7),
12, SSA CLD–P scores of 11 or greater g/dL; or (m)(8), and (m)(9) as paragraphs (m)(3),
calculated as described in 105.00D11b. 2. Serum albumin of 3.0 g/dL or less; or (m)(4), (m)(5), (m)(6), (m)(7), and (m)(8).
Consider under a disability from at least the 3. Fat-soluble vitamin, mineral, or trace
date of the first score. mineral deficiency; [FR Doc. E7–20235 Filed 10–18–07; 8:45 am]
OR AND BILLING CODE 4191–02–P

Rule: Social Security Benefits: Federal Old Age, Survivors, and Disability Insurance&#8212 Digestive System Impairments Medical Criteria Evaluation

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Rule: Social Security Benefits: Federal Old Age, Survivors, and Disability Insurance&#8212 Digestive System Impairments Medical Criteria Evaluation

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Friday,

October 19, 2007

5.00E—How do we evaluate and weight measurements to BMI 5.00I—How do we evaluate impairments

note differences like the fact that we use

the proposed provisions; and to present all views adequately and to

Disability means you have a medically determinable impairment(s) as

3. Do you have an impairment(s) that

FY 2008 FY 2009 FY 2010 FY 2011 FY 2012 Total

¥$10 ¥$19 ¥$27 ¥$35 ¥$42 ¥$132 5

FY 2008 FY 2009 FY 2010 FY 2011 FY 2012 Total

¥$1 ¥$3 ¥$5 ¥$8 ¥$8 ¥$25 6

d. International Normalized Ratio (INR) of Part A

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