[Federal Register: October 19, 2007 (Volume 72, Number 202)]
[Rules and Regulations]
[Page 59397-59431]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19oc07-16]
[[Page 59397]]
-----------------------------------------------------------------------
Part III
Social Security Administration
-----------------------------------------------------------------------
20 CFR Parts 404 and 416
Revised Medical Criteria for Evaluating Digestive Disorders; Final Rule
[[Page 59398]]
-----------------------------------------------------------------------
SOCIAL SECURITY ADMINISTRATION
20 CFR Parts 404 and 416
[Docket No. SSA 2006-0094]
RIN 0960-AF28
Revised Medical Criteria for Evaluating Digestive Disorders
AGENCY: Social Security Administration.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: We are revising the criteria in the Listing of Impairments
(the listings) that we use to evaluate claims involving digestive
disorders. We apply these criteria when you claim benefits based on
disability under title II and title XVI of the Social Security Act (the
Act). The revisions reflect advances in medical knowledge, methods of
evaluating digestive disorders, treatment, and our program experience.
We are also removing listings that are redundant because they only
refer to other listings, and we are making other conforming changes.
DATES: These rules are effective December 18, 2007.
FOR FURTHER INFORMATION CONTACT: James Julian, Director, Office of
Medical Policy, Social Security Administration, 4470 Annex Building,
6401 Security Boulevard, Baltimore, Maryland 21235-6401, 410-965-4015.
For information on eligibility or filing for benefits, call our
national toll-free number 1-800-772-1213 or TTY 1-800-325-0778, or
visit our Internet Web site, Social Security Online, at http://www.socialsecurity.gov
.
SUPPLEMENTARY INFORMATION:
Electronic Version
The electronic file of this document is available on the date of
publication in the Federal Register at http://www.gpoaccess.gov/fr/index.html
.
Background
We are revising and making final the rules we proposed in the
Notice of Proposed Rulemaking (NPRM) published in the Federal Register
on November 14, 2001 (66 FR 57009). We provide a summary of the
provisions of the final rules below, with an explanation of the changes
we have made from the text in the NPRM. We also provide summaries of
the public comments and our reasons for adopting or not adopting the
recommendations in these comments in the section, ``Public Comments.''
The final rule language follows the public comments.
After we published the NPRM, we also:
Published final rules on April 24, 2002, entitled
Technical Revisions to Medical Criteria for Determinations of
Disability (67 FR 20018). In those final rules, we added listings 5.09
and 105.09 for liver transplantation. We also made minor technical
changes to our listings to include references to modern imaging
techniques. These final rules do not make substantive changes to the
rules we published on April 24, 2002, although we are making minor
editorial changes.
Published a notice on November 8, 2004, providing a 60-day
extension of the comment period on the NPRM for the limited purpose of
accepting comments about the proposals regarding chronic liver disease
(69 FR 64702). We explain this extension in more detail in the public
comments section of this preamble.
Held an outreach meeting in Cambridge, Massachusetts on
November 17, 2004, regarding our listings for chronic liver disease. We
describe this meeting in more detail in the public comments section of
this preamble.
Why are we revising the listings for digestive disorders?
We reviewed the prior digestive disorder listings and determined
that they should be revised in light of our program experience and
advances in medical knowledge, methods of evaluating digestive
disorders, and treatment. We last published final rules comprehensively
revising the digestive disorder listings in the Federal Register on
December 6, 1985 (50 FR 50068). In the introductory text to those
rules, we stated our intention to periodically review and update these
listings due to medical advances in treatment and our program
experience.
What do we mean by ``final rules'' and ``prior rules''?
Even though these rules will not go into effect until 60 days after
publication of this notice, for clarity we refer to the changes we are
making here as the ``final rules'' and to the rules that will be
changed by these final rules as the ``prior rules.''
When will we start to use these final rules?
We will start to use these final rules on their effective date. We
will continue to use our prior rules until the effective date of these
final rules. When these final rules become effective, we will apply
them to new applications filed on or after the effective date of these
rules and to claims pending before us, as we describe below.
As is our usual practice when we make changes to our regulations,
we will apply these final rules on or after their effective date when
we make a determination or decision, including those claims in which we
make a determination or decision after a remand to us from a Federal
court. With respect to claims in which we have made a final decision
and that are pending judicial review in Federal court, we expect that
the court would review the Commissioner's final decision in accordance
with the rules in effect at the time the final decision of the
Commissioner was issued. If a court reverses the Commissioner's final
decision and remands the case for further administrative proceedings
after the effective date of these final rules, we will apply the
provisions of these final rules to the entire period at issue in the
claim in our new decision issued pursuant to the court's remand.
How long will these rules be in effect?
These rules will be in effect for 5 years after the date they
become effective, unless we extend them or revise and issue them again.
What general changes are we making that affect both the adult and
childhood listings for digestive disorders?
We are clarifying the listing criteria and making them easier to
use by:
Removing reference listings and, when appropriate,
providing guidance in the introductory text of the listings. Reference
listings are listings that are met by satisfying the criteria of
another listing. For example, an impairment could meet prior listing
5.03, Stricture, stenosis, or obstruction of the esophagus, with weight
loss ``as described under listing 5.08.'' Prior listing 5.08 required
weight loss of a specific amount due to ``any persisting
gastrointestinal disorder.'' Therefore, prior listing 5.03 was
redundant because we could also evaluate weight loss from stricture,
stenosis, or obstruction of the esophagus under listing 5.08 alone.
Removing or updating outdated listings.
Adding criteria to the listing for chronic liver diseases
and expanding the guidance in the introductory text on how we evaluate
these diseases, including specific guidance on chronic viral hepatitis
infections.
Revising and adding criteria to the listing for
inflammatory bowel diseases and expanding the introductory text to
include guidance on how we evaluate these digestive disorders.
Adding a listing for short bowel syndrome and providing
guidance in the introductory text for this disorder.
[[Page 59399]]
Expanding the introductory text to include guidance on how
we consider the effects of treatment.
Providing general guidance in the introductory text
explaining how we evaluate digestive disorders that do not meet these
listings.
Making nonsubstantive editorial changes to update the
medical terminology in the listings and to be consistent with plain
language guidelines.
We discuss other changes in the listings below, in our detailed
explanation of the revised listings.
How are we changing the introductory text to the listings for
evaluating digestive disorders in adults?
5.00 Digestive System
We are revising the introductory text for this body system to
provide additional guidance for evaluating digestive disorders and to
update its medical terminology. We are also removing references to
digestive disorders and complications of digestive disorders, such as
peptic ulcer disease, fistulae, and abscesses, that generally are not
of listing-level severity. (However, as we explain below, we are
including fistulae and abscesses as criteria in final listing 5.06 for
inflammatory bowel disease.)
We are including relevant material from prior 5.00A in final 5.00A
and final 5.00C.
We are updating and moving relevant material from prior 5.00B to
final 5.00G.
We are moving relevant material from prior 5.00C to final 5.00E. We
are removing the portion of prior 5.00C that dealt with peptic ulcer
disease because advances in diagnosis, evaluation, and treatment of
this impairment make the surgical interventions discussed in the prior
section (including gastrectomy, vagotomy, and pyloroplasty) much less
common.
Following is a detailed, section-by-section explanation of the
final introductory text material.
5.00A--What kinds of disorders do we consider in the digestive system?
This section revises prior 5.00A. We list the major types of
digestive disorders included in these listings and provide an example
of a complication that may result from them. In the NPRM, we proposed
to include information in this section from prior 5.00C about colostomy
and ileostomy. However, we moved this information to final 5.00E as
part of the general reorganization of the introductory text. We also
proposed to explain that gastrointestinal impairments frequently
respond to treatment; therefore, their severity should be evaluated in
the context of prescribed treatment. We moved this information to
5.00C, ``How do we consider the effects of treatment?'' where it more
logically fits.
5.00B--What documentation do we need?
In this new section, we include examples of the types of clinical
and laboratory findings that should be part of the longitudinal
evidence. This section also includes two sentences describing
appropriate medically acceptable imaging that were not in the NPRM, but
that we added in the aforementioned final rules making technical, but
not policy, changes to our listings. We revised the sentence describing
medically acceptable imaging so that it more appropriately reflects
imaging techniques used for digestive disorders. We also moved to this
section a revised version of the first sentence of proposed 5.00C2,
which explains that the specific findings required by these listings
must occur within the period we are considering in connection with an
individual's application or continuing disability review.
In response to public comments we describe later in this preamble,
we removed the sentence in proposed 5.00B1 explaining that we usually
need longitudinal evidence covering a period of at least 6 months of
observations and treatment unless we can make a fully favorable
determination or decision without it. Instead, we are providing
timeframes for the evidence requirements in each listing.
We moved proposed 5.00B2, which explained how we evaluate claims
when an individual has not received ongoing treatment or does not have
an ongoing relationship with the medical community despite the
existence of a severe impairment, to final 5.00C where it fits more
logically with our discussion of treatment issues.
5.00C--How do we consider the effects of treatment?
In the NPRM, proposed 5.00C was titled, ``How do we evaluate
digestive disorders that require recurring or persistent findings?''
Proposed 5.00C1 defined ``recurring'' and ``persisting'' as used in
listings 5.02, 5.05, 5.06, and 5.08, and proposed 5.00C2 explained when
the ``events'' required to satisfy the listings must occur. In these
final rules, we removed the references to recurring or persistent
findings from the digestive listings. We also moved the first sentence
of 5.00C2 to final 5.00B. We no longer need the second sentence of
proposed 5.00C2 because of changes we made to the listings. Therefore,
we removed all of proposed 5.00C. We explain the reasons for the
changes to the listings later in this preamble.
We explain how we consider the effects of treatment in final 5.00C.
This section is an expansion of proposed 5.00D. It includes six
paragraphs that address treatment issues, rather than the three
paragraphs we proposed. As we have already noted, we moved the
additional paragraphs from other sections to present the information
more logically.
General Information About Final 5.00D Through 5.00G
In the NPRM, proposed 5.00F was titled ``What are our guidelines
for evaluating specific digestive impairments?'' Proposed 5.00F1
addressed malnutrition and weight loss, and proposed 5.00F2 addressed
chronic liver disease. In these final rules, we are greatly expanding
the introductory text from the NPRM in response to public comments and
adding more discussion about digestive disorders, especially chronic
liver disease and inflammatory bowel disease. Since we are including
significantly more information in these final rules, we are addressing
each kind of digestive disorder in its own separate section. Also, the
guidance about specific disorders under proposed 5.00F was not in the
order of the proposed listings. In the final rules, we are providing
guidance that generally follows the structure of the final listings.
Thus:
Final 5.00D addresses chronic liver disease (final listing
5.05);
Final 5.00E addresses inflammatory bowel disease (final
listing 5.06);
Final 5.00F addresses short bowel syndrome (final listing
5.07); and
Final 5.00G addresses weight loss due to any digestive
disorder (final listing 5.08).
5.00D--How do we evaluate chronic liver disease?
In final 5.00D (proposed 5.00F2), we define chronic liver disease,
provide examples of it, and describe its manifestations. In response to
hundreds of public comments regarding hepatitis C, we are greatly
expanding this section to explain how we evaluate chronic viral
hepatitis, including chronic hepatitis B and C infections, and we
describe extrahepatic manifestations of these infections. In addition,
we include guidance for considering the effects of specific treatment
modalities for hepatitis B and C infections. We also present
information on conditions that we include in the chronic liver disease
listing (that is, gastrointestinal
[[Page 59400]]
hemorrhage, ascites or hydrothorax, spontaneous bacterial peritonitis,
hepatorenal syndrome, hepatopulmonary syndrome, hepatic encephalopathy,
end stage liver disease, and liver transplantation).
Final 5.00D contains 12 sections:
Final 5.00D1, D2, and D3 are a reorganization of the
information presented in proposed 5.00F2(a), F2(b), and F2(d).
In final 5.00D1, we define chronic liver disease and name
the manifestations of chronic liver disease that we consider under
these listings. We removed the phrase in proposed 5.00F2 indicating
that chronic liver disease must be ``expected to continue for 12
months'' because it is unnecessary. Under our general rules for
evaluating disability, an impairment must meet the duration
requirement.
We also removed the phrase in proposed 5.00F2d explaining
that we would ``assess impairment due to hepatic encephalopathy under
the criteria for the appropriate mental disorder or neurological
listing(s).'' In response to public comments, we are adding a listing
for hepatic encephalopathy (final listing 5.05F).
Final 5.00D2 presents an expanded list of examples of
chronic liver disease, including some diseases, such as Wilson's
disease and chronic hepatitis, which we included in the heading of
prior listing 5.05 but not in the heading of final listing 5.05.
Final 5.00D3 is an expansion of proposed 5.00F2d. It has
three paragraphs that describe the symptoms (5.00D3a), signs (5.00D3b),
and laboratory findings (5.00D3c) associated with the manifestations of
chronic liver disease.
In response to a comment, we are including guidance in final
5.00D3a to explain that symptoms may correlate poorly with the severity
of chronic liver disease.
In final 5.00D3c, we are clarifying our intent in proposed 5.00F2d,
where we explained that abnormal liver function test findings may
correlate poorly with the clinical severity of liver disease. Although
that guidance is applicable to liver function tests such as serum total
bilirubin or liver enzyme levels, it is not applicable to all tests
indicative of liver function. In final 5.00D3c, we now explain that
abnormally low serum albumin or elevated International Normalized Ratio
(INR) levels are exceptions because they are indicators of significant
liver disease. As we note below, we include criteria for abnormally low
serum albumin and elevated INR in final listings 5.05B and 5.05F.
We are also not including the statement from proposed 5.00F2d that
liver function tests ``must not be relied upon in isolation'' because
it is unnecessary. In final 5.00D3c, we are also expanding the rules
from what we had proposed to include information on documenting chronic
liver disease with a liver biopsy or imaging studies.
Final 5.00D4 is new; there was no corresponding section in
the NPRM. We added it in response to hundreds of comments concerning
the growing incidence of hepatitis. In final 5.00D4a, we provide
general information about chronic viral hepatitis infections. In final
5.00D4b, we provide information about chronic hepatitis B infection. In
final 5.00D4c, we provide detailed information about chronic hepatitis
C infection, including a paragraph explaining adverse effects of
treatment that may contribute to a finding of disability. In final
5.00D4d, we provide information about the extrahepatic manifestations
of hepatitis B and C infections that may result in, or contribute to, a
finding of disability.
Final 5.00D5 corresponds to proposed 5.00F2c. In it, we
provide guidance for evaluating gastrointestinal hemorrhages under
final listings 5.02 and 5.05A. As we explain in more detail below, we
have revised proposed listings 5.02 and 5.05A in these final rules, and
final 5.00D reflects the changes to the listings. For example, in
response to comments, we expanded the scope of listing 5.05A to include
hemorrhages from gastric or ectopic varices and portal hypertensive
gastropathy in addition to hemorrhages from esophageal varices. Also in
response to comments, we removed the proposed criterion for ``massive''
hemorrhage requiring transfusion of at least 5 units of blood in 48
hours. Instead, final listing 5.05A requires hemorrhaging which results
in ``hemodynamic instability,'' which we describe in final 5.00D5.
In final 5.00D6, we provide guidance for evaluating
ascites or hydrothorax under final listing 5.05B. In response to
comments, we have revised proposed listing 5.05B; therefore, final
5.00D6 reflects the changes we made to that listing. We explain those
changes later in this preamble.
We also removed the statement in proposed 5.00F2d that current
imaging techniques are capable of identifying even minimal amounts of
ascites before they can be detected on physical examination. We made
this change because final listing 5.05B is met based on laboratory
findings coupled with documentation of the ascites or hydrothorax. If
these laboratory findings are at the level specified in the listing, it
is not necessary to quantify the ascites.
Final 5.00D7, D8, and D9 are also new in these final
rules. In response to comments, we are including listing criteria in
final listing 5.05 for three serious complications of chronic liver
disease: Spontaneous bacterial peritonitis (final listing 5.05C);
hepatorenal syndrome (final listing 5.05D); and hepatopulmonary
syndrome (final listing 5.05E). Each new section explains how the
condition is diagnosed and the documentation requirements for the new
listings.
In final 5.00D10, we provide guidance for evaluating
hepatic encephalopathy under final listing 5.05F. As noted earlier, we
added this listing in response to comments. In 5.00D10a, we explain how
hepatic encephalopathy is diagnosed and identify the documentation
requirements for the new listing. In final 5.00D10b, we explain that we
will not evaluate acute encephalopathy under listing 5.05F if it
results from conditions other than chronic liver disease.
Final 5.00D11 is also new in these final rules. In
response to public comments, we added listing 5.05G, for end stage
liver disease (ESLD) with SSA Chronic Liver Disease (SSA CLD) scores of
22 or greater. The SSA CLD calculation is a calculation we developed
based on the Model for End Stage Liver Disease (MELD) calculation. The
MELD is a numerical scale developed for the United Network for Organ
Sharing (UNOS) that is used for liver allocation within the Organ
Procurement and Transplantation Network. The MELD score is based on
objective and verifiable medical data, and estimates an individual's
risk of dying while waiting for a liver transplant. In final 5.00D11a,
we explain that we will use the SSA CLD score to evaluate your end
stage liver disease under final listing 5.05G. In final 5.00D11b-g, we
explain how we calculate the SSA CLD score; for example, what
laboratory values we use, when they must be obtained, and the formula
we use to do the calculation.
Final 5.00D12 corresponds to 5.00F2e and F2g in the NPRM.
It explains how we evaluate liver transplantation 1 year after the date
of the transplantation. The final rule is similar to the proposed rule;
we edited it for clarity and expanded it slightly to provide more
information about when liver transplantations are performed.
[[Page 59401]]
5.00E--How do we evaluate inflammatory bowel disease (IBD)?
In response to public comments, we are greatly expanding the
listing criteria for inflammatory bowel disease, final listing 5.06,
and adding a new section, final 5.00E, to the introductory text to
provide guidance for evaluating IBD under these expanded criteria.
Final 5.00E contains four paragraphs:
In final 5.00E1, we explain the general characteristics of
IBD;
In final 5.00E2, we list common symptoms, signs, and
laboratory findings associated with IBD;
In final 5.00E3, we describe some of the more common
extraintestinal manifestations of IBD affecting different body systems;
and
In final 5.00E4, we explain how we consider surgical
procedures such as ileostomy and colostomy. Final 5.00E4 corresponds to
the first sentence of prior 5.00C and proposed 5.00A3.
5.00F--How do we evaluate short bowel syndrome (SBS)?
In response to public comments, we are adding a new listing for
short bowel syndrome, final listing 5.07, and a new section in the
introductory text, final 5.00F, to provide guidance for evaluating SBS
under this listing.
5.00G--How do we evaluate weight loss due to any digestive disorder?
Final 5.00G corresponds to prior 5.00B and proposed 5.00F1 and
reflects changes we made to proposed listing 5.08, discussed below. We
are simplifying the guidance from prior 5.00B about evaluating
malnutrition and weight loss. Under the final rules, it is sufficient
for our purposes that the weight loss result from any medically
determinable digestive disorder. We are also revising the heading of
final 5.00G to refer only to weight loss, instead of the proposed
reference to malnutrition and weight loss, to better reflect the
content of the section.
We revised proposed listing 5.08 to use Body Mass Index (BMI) to
evaluate weight loss instead of using height and weight measurements by
gender. BMI is the measurement recommended by the Centers for Disease
Control and Prevention (CDC) to determine appropriate weight for
height. In final 5.00G1, we explain that we use BMI to evaluate weight
loss due to any digestive disorder under listing 5.08 and to evaluate
lesser weight loss from IBD under listing 5.06B. The latter is one of
the new criteria that we added to the IBD listing in response to public
comments.
In final 5.00G2, we explain how we calculate BMI. The change from
height and weight measurements to BMI removed the need to provide rules
for rounding of height and weight measurements; therefore, we do not
include in these final rules the rules for rounding that were in
proposed 5.00F1a-F1c.
5.00H--What do we mean by the phrase ``consider under a disability for
1 year''?
Final 5.00H corresponds to proposed 5.00F2f; however, we revised it
to make clear that the phrase refers to the date on which we must
determine whether an impairment continues to meet a listing or is
otherwise disabling, not the date on which disability began. We explain
that we do not restrict our finding about the onset date of disability
to the date of a specific qualifying event in a listing, such as a
liver transplant. For example, many individuals who need liver
transplants (final listing 5.09) have impairments that meet one of the
criteria for chronic liver disease (final listing 5.05) before they
have their liver transplants.
In the proposed rules, we had inadvertently included the
explanation of the phrase ``consider under a disability for 1 year''
under the heading for chronic liver disease; however, we also use the
phrase in final listing 5.02 for gastrointestinal hemorrhaging from any
cause. Therefore, in the final rules, we explain the phrase in a
section that is independent of the discussion of chronic liver disease,
and we identify the three listings to which it applies.
In proposed 5.00F2f, we had also stated that the phrase was a
``statement about the expected duration of disability.'' In reviewing
that language, we realized that it could have been misunderstood to
mean that we presume that an individual will no longer be disabled
after 1 year. That was not our intent. Rather, we intended to indicate
only that after 1 year the impairment would no longer meet the
requirements of the particular listing that includes the criterion. The
impairment may still be disabling at the end of the period because it
may meet or medically equal another listing or result in a residual
functional capacity that is consistent with a finding of disability.
Also, when we consider whether an impairment continues to be disabling,
we apply the medical improvement review standard in Sec. Sec. 404.1594
and 416.994. For these reasons, we are not including the statement in
these final rules.
5.00I--How do we evaluate impairments that do not meet one of the
digestive disorder listings?
Final 5.00I is generally the same as proposed 5.00E, except that we
include hepatitis B or C that results in depression as an example of a
digestive impairment we would evaluate in another body system, instead
of the hepatic encephalopathy example we included in proposed 5.00E1.
This example was no longer appropriate because we have a listing for
hepatic encephalopathy (5.05F) in the final rules.
How are we changing the listings for evaluating digestive disorders in
adults?
5.01 Category of Impairments, Digestive System
Removal of Redundant or Reference Listings
We are removing four prior listings because they were reference
listings and, therefore, were redundant. These four listings were met
by referring to the requirements of prior listing 5.08:
5.03--Stricture, stenosis, or obstruction of the esophagus
with weight loss;
5.04D--Peptic ulcer disease with weight loss;
5.06E--Chronic ulcerative or granulomatous colitis with
weight loss; and
5.07D--Regional enteritis with weight loss.
All of these impairments are still covered by final listing 5.08.
Chronic ulcerative or granulomatous colitis and regional enteritis are
also covered by final listing 5.06. We no longer mention them
explicitly in these final rules because they have been replaced by the
more encompassing term ``inflammatory bowel disease.''
Prior listing 5.05E, hepatic encephalopathy, was also a reference
listing, referring to listing 12.02. In the NPRM, we proposed to remove
the listing and to add language in proposed sections 5.00E1 and 5.00F2b
that reminded adjudicators to evaluate the impairment under the
criteria for the appropriate mental disorder or neurological listing.
However, in response to many public comments, we decided to remove the
proposed guidance and to provide a new listing specifically for hepatic
encephalopathy in the digestive listings, final listing 5.05F.
Therefore, while we are still removing prior reference listing 5.05E,
we are including a different listing for hepatic encephalopathy in
these final rules.
[[Page 59402]]
We are also removing the following prior listings because medical
knowledge, methods of evaluating digestive disorders, advances in
treatment, and our program experience indicate that they are no longer
appropriate indicators of listing-level severity. There has been
significant progress in the treatment of these digestive disorders.
Many of these disorders can be controlled or resolved and thus are less
likely to be of listing-level severity. Even if listing-level severity
is initially present, the 12-month statutory duration requirement will
often not be met.
5.04--Peptic ulcer disease (demonstrated by endoscopy or
other appropriate medically acceptable imaging). Advances in medical
and surgical management have made less common many complications from
peptic ulcer disease, such as recurrent ulceration (prior listing
5.04A), fistula formation (prior listing 5.04B), and recurrent
obstruction (prior listing 5.04C). Treatment often results in
significant improvement, therefore the prior listing criteria for these
impairments are no longer appropriate indicators of listing-level
severity.
5.05B--Chronic liver disease with performance of a shunt
operation for esophageal varices. When we first published this listing,
only surgical shunts involving extensive abdominal surgery were
available. These surgeries were not usually performed until the chronic
liver disease became serious enough to justify the risks associated
with prolonged surgery and anesthesia. More recently, transjugular
intrahepatic portosystemic shunts (TIPS), which are performed with
minimal anesthesia and with fewer complications, have largely replaced
abdominal surgical shunts in treating the complications of portal
hypertension, such as bleeding gastroesophageal varices or refractory
ascites. However, in the final listing for hepatic encephalopathy,
final listing 5.05F, we are adding a criterion for a history of TIPS in
combination with other findings that describe an impairment that is of
listing-level severity.
5.05C--Chronic liver disease with specific levels of serum
total bilirubin. Prior listing 5.05C required only a persistently
elevated serum total bilirubin level. We are removing this listing
because this laboratory finding alone does not correlate sufficiently
with the ability to function.
5.05F--Chronic liver disease with liver biopsy. This
listing required confirmation of chronic liver disease by a liver
biopsy, with another specified clinical or laboratory finding. We are
removing this listing because a liver biopsy, while confirming the
presence of liver disease, does not correlate with any specific level
of impairment severity or decrease in ability to function. We assess
the clinical findings described in prior listings 5.05F1 and F3 in
other final listings, and we are removing the requirement for elevated
serum total bilirubin level in prior listing 5.05F2 because it does not
sufficiently demonstrate impairment severity or correlate with the
ability to function.
5.06A--Chronic ulcerative or granulomatous colitis with
recurrent bloody stools documented on repeated examinations and anemia
manifested by hematocrit of 30 percent or less. These criteria alone
were not appropriate indicators of listing-level severity. However, we
have incorporated a criterion for anemia in final listing 5.06, the new
listing for IBD that we added in response to public comments.
5.06B and 5.07--Persistent or recurrent systemic
manifestations, such as arthritis, iritis, fever, or liver dysfunction
due to chronic ulcerative or granulomatous colitis or regional
enteritis. These listings required only the presence of a systemic
manifestation in another body system or organ, without regard to degree
of severity or impact on functioning. Therefore, they were not
appropriate indicators of listing-level severity. However, in response
to public comments described below, we are including examples of
significant extraintestinal manifestations in final 5.00E3 with
instructions to our adjudicators to consider these manifestations when
determining whether the individual has an impairment(s) that meets or
medically equals another listing and when assessing residual functional
capacity. The examples include arthritis, iritis, and other effects.
5.06C and 5.07C--Intermittent obstruction due to
intractable abscess, fistula formation, or stenosis as a result of
chronic ulcerative or granulomatous colitis or regional enteritis.
Advances in surgical treatment have improved the management of these
disorders, thus these listings are no longer appropriate indicators of
listing-level severity. However, in final listing 5.06B, we include
intestinal obstruction, abscess, fistula, and stenosis as criteria that
can satisfy the requirements of the listing.
5.06D--Recurrence of findings in listing 5.06A, B, or C
after total colectomy. We are removing this listing consistent with our
removal of listings 5.06A, B, and C.
5.08B--Weight loss due to any persisting digestive
disorder, with weight equal to or less than the values specified in
Table III or IV and one of the listed abnormal laboratory findings
present on repeated examinations. This listing allowed a lesser level
of weight loss than that required to meet listing 5.08A when
accompanied by one of the additional listed findings. Those findings,
however, did not correlate with any specific level of impairment
severity or decrease of ability to function that would be an accurate
indicator of listing-level severity. However, in response to public
comments, we are including a 10 percent weight loss from baseline as
one of the criteria that can be used to meet final listing 5.06 for
individuals who have IBD.
The following is a detailed explanation of the final listings.
Listing 5.02--Gastrointestinal Hemorrhaging From Any Cause, Requiring
Blood Transfusion
We are expanding this listing to include ``gastrointestinal
hemorrhage from any cause'' instead of the prior listing's ``upper
gastrointestinal hemorrhage from undetermined cause.'' We are also
revising the severity criterion in this listing from anemia with a
persistent hematocrit level of 30 percent or less, to a requirement for
gastrointestinal hemorrhages that require blood transfusions of at
least 2 units of blood per transfusion, occurring at least three times,
at least 30 days apart, during a consecutive 6-month period. A
hematocrit level by itself is generally not an appropriate indicator of
the severity of gastrointestinal hemorrhage, and as we have already
noted, does not necessarily correlate with inability to function.
In these final rules, we are clarifying the proposed rule to
explain that an individual does not have to be hospitalized for
transfusions under this listing. We did not indicate whether
hospitalization was required in the proposed rule. Therefore, this is
only an editorial change for clarity.
The proposed listing indicated in a parenthetical statement that
``[a]ll incidents [hemorrhages] within a consecutive 14-day period
constitute one episode.'' In the final listing, we are revising this
statement by removing references to ``incidents'' and ``episodes'' and
instead simply using the word ``transfusions,'' since transfusions are
the indicators of severity. Also, in response to a public comment, we
are increasing the length of time between blood transfusions (described
as ``episodes'' in the proposed rule) from 14 days to 30 days.
[[Page 59403]]
Since improvements in medical treatment may resolve the frequency
of hemorrhages and thus the overall severity of the impairment, we
indicate that we will consider an individual to be under a disability
for 1 year following the last documented transfusion. After that, we
will evaluate the residual impairment(s).
Listing 5.05--Chronic Liver Disease
We are replacing prior listing 5.05 with criteria that more
accurately reflect listing-level severity.
We are removing the parenthetical examples of chronic
liver diseases from the heading of prior listing 5.05 because these
references could have been misinterpreted to mean that we included only
those specific conditions under the listing. However, in response to
comments, we continue to use Wilson's disease and chronic hepatitis as
examples of chronic liver diseases that are covered by final listing
5.05 in final 5.00D2 of the introductory text. In a change from the
NPRM, and in response to many comments, we are revising the heading of
the listing to refer to ``chronic liver disease'' only. We removed
``and cirrhosis of any kind'' from the heading because cirrhosis is a
form of chronic liver disease.
In final listing 5.05A, we are expanding the scope of
prior and proposed listing 5.05A in response to comments to include
hemorrhaging from esophageal, gastric, or ectopic varices, or from
portal hypertensive gastropathy. The proposed listing required
``massive'' hemorrhage requiring ``5 units of blood in 48 hours.'' In
response to comments, we changed the requirement for ``massive''
hemorrhage to hemorrhaging that results in hemodynamic instability, and
we changed the transfusion requirements from the proposed ``5 units of
blood in 48 hours'' to ``at least 2 units of blood.'' We chose 2 units
of blood because this is the minimum amount of blood that is usually
transfused. We define ``hemodynamic instability'' in 5.00D5.
Newer techniques in primary prevention and treatment of bleeding
gastroesophageal varices, for example, TIPS, banding, sclerotherapy,
and laser therapy, have significantly improved the management of
bleeding varices. Based on these advances, it is no longer appropriate
to presume disability for 3 years as under prior listing 5.05A.
Therefore, the final listing (like the proposed listing) provides that
we will consider an individual disabled for 1 year following the last
documented transfusion. After that, we will evaluate the residual
impairment(s).
Final listing 5.05B corresponds to prior listing 5.05D, ascites due
to chronic liver disease. In response to comments, we are also
including hydrothorax in the listing because ascitic fluid can collect
in the chest cavity and result in a very serious impairment. Therefore,
we are including thoracentesis in the documentation requirements in
final listing 5.05B1 because it provides a definitive diagnosis of
hydrothorax, just as paracentesis provides a definitive diagnosis of
ascites.
As in the NPRM, we are revising the required time period in which
the evaluations showing ascites or hydrothorax must occur from 5 months
to 6 months because, in our experience, a 6-month period enables us to
make a more reliable prediction of duration of an impairment of
listing-level severity. We also are requiring that evaluations be done
at least 60 days apart within the 6-month period to substantiate the
chronic nature of the impairment.
In response to public comments, final listing 5.05B2 now requires
documentation of ascites or hydrothorax by physical examination or by
appropriate medically acceptable imaging, but not both, as we proposed
in the NPRM. However, if the ascites or hydrothorax is documented by
physical examination or imaging rather than paracentesis or
thoracentesis, we require additional laboratory findings that confirm
very serious chronic liver disease. As in proposed listing 5.05B2a, we
require serum albumin of 3.0 g/dL or less. In response to public
comments, we changed the proposed criterion for a measure of
prothrombin time to a criterion for an elevated International
Normalized Ratio (INR) of at least 1.5 in final listing 5.05B2b. The
public comments correctly indicated that INR is a more widely used
study.
In response to public comments, we are also adding three
new listings for serious complications of chronic liver disease: Final
listing 5.05C for spontaneous bacterial peritonitis; final listing
5.05D for hepatorenal syndrome; and final listing 5.05E for
hepatopulmonary syndrome. These complications are so severe that we
require only one occurrence of any one of them, shown by the requisite
findings, to satisfy the listing.
As already noted, we are also adding a new listing 5.05F
for hepatic encephalopathy. The new listing requires hepatic
encephalopathy documented by abnormal behavior, cognitive dysfunction,
changes in mental status, or altered state of consciousness, present on
at least two evaluations at least 60 days apart within a consecutive 6-
month period, with associated physical signs or laboratory findings,
occurring with the same frequency and during the same time period; or a
history of a TIPS or any surgical portosystemic shunt procedure.
In response to comments that individuals on liver
transplant lists should qualify, we are adding another new listing,
final listing 5.05G, for evaluating individuals with ESLD. We are using
an SSA CLD score criterion as an objective means to measure listing-
level severity. As discussed above, we based the SSA CLD calculation on
the MELD calculation used by UNOS to prioritize individuals ages 12 and
over on a national liver transplantation list according to the severity
of their liver disease. (There is also a Pediatric End Stage Liver
Disease scoring system, called PELD, for children under age 12. We have
developed an SSA Chronic Liver Disease--Pediatric (SSA CLD-P)
calculation based on that system that we have included in the part B
listings, as we explain below.) The SSA CLD score determination relies
only on objective criteria, with standardized laboratory determinations
that are readily available and reproducible.
We did not agree that all individuals on transplant lists should
qualify under our listings because the threshold criteria for placement
on a transplant list vary widely throughout the country and some
individuals are placed on transplantation lists well before they have
listing-level impairments. In the final rule, we provide that a SSA CLD
score of 22 or greater meets the listing. We chose this score based on
the clinical severity represented by the laboratory values contained in
the SSA CLD score.
For final listing 5.05G, we require two calculations of SSA CLD
scores, at least 60 days apart, and that the scores must be calculated
within a consecutive 6-month period, consistent with other provisions
in these final rules.
Listing 5.06--Inflammatory Bowel Disease
We are combining portions of prior listings 5.06 and 5.07 into
final listing 5.06. Ulcerative colitis, Crohn's disease, granulomatous
colitis, and regional enteritis are now commonly referred to as
``inflammatory bowel disease'' (IBD).
In the NPRM, proposed listing 5.06 required documentation of IBD
with persistent or recurrent intestinal obstruction. The proposed
listing repeated the criteria from prior listing 5.07A, clarified that
the intestinal obstruction must be documented by appropriate medically
acceptable imaging or operative findings, and
[[Page 59404]]
included the requirement for documentation of two episodes of
obstruction over a consecutive 6-month period despite prescribed
treatment, to ensure that there is a chronic impairment.
In response to public comments, we are significantly revising and
expanding final listing 5.06. As in the proposed listing, the
introductory paragraph of final listing 5.06 requires documentation of
IBD by endoscopy, biopsy, appropriate medically acceptable imaging, or
operative findings. As in the NPRM, final listing 5.06A requires
obstruction of stenotic areas in the small intestine or colon with
proximal dilatation. We are clarifying in the final rule that adhesions
do not satisfy the requirement for obstruction. This is not a
substantive change but a clearer statement of our intent that there
must be obstruction that results from IBD. We are also clarifying that,
in these cases, the stenotic areas may be shown by surgery or by
medically acceptable imaging. In addition, we are clarifying the
language we had proposed by requiring hospitalization for treatment of
the obstruction (intestinal decompression or surgery). This is not a
substantive change from the NPRM because listing-level obstruction of a
stenotic area would require hospitalization for one of these types of
treatment. Therefore, the requirement in the final listing will only
help to confirm the existence of listing-level obstruction caused by
IBD.
We are deleting the proposed requirement for persistent or
recurrent obstruction over a consecutive 6-month period despite
prescribed treatment in response to a public comment. Instead, we are
requiring that the findings occur on at least two distinct occasions at
least 60 days apart within a consecutive 6-month period.
Final listing 5.06B includes six other manifestations of IBD that
were suggested by commenters. Consistent with most of the other
criteria in the final rules for impairments that have episodic
manifestations, final listing 5.06B requires that two of the six
criteria be present on at least two evaluations, occurring at least 60
days apart within the same consecutive 6-month period, except for
listing 5.06B6, which requires supplemental daily enteral nutrition via
a gastrostomy or daily parenteral nutrition via a central venous
catheter.
Listing 5.07--Short Bowel Syndrome
As we explained earlier, we are removing prior listing 5.07, for
regional enteritis. Instead, we evaluate this condition under final
listing 5.06, for IBD. However, in response to comments regarding
individuals who need parenteral nutrition, we are adding a new listing,
final listing 5.07, for short bowel syndrome to address situations in
which post-operative nutritional needs cannot be met orally or with
supplemental enteral nutrition. This final listing requires a diagnosis
of short bowel syndrome due to surgical resection of more than one-half
of the small intestine with resulting dependence on daily parenteral
nutrition via a central venous catheter.
Listing 5.08--Weight Loss Due to Any Digestive Disorder
In this final rule, we changed the heading of prior and proposed
listing 5.08, ``Weight loss due to any persisting gastrointestinal
disorder'' to ``Weight loss due to any digestive disorder.'' We deleted
the word ``persisting'' for reasons we explain in the public comments
section of this preamble.
In final listing 5.08, we are establishing the severity of the
weight loss based on the CDC's BMI formula, rather than the
Metropolitan Life Insurance Company's weight charts we used in the
proposed rules and which were last updated in 1983. When we published
the NPRM in 2001, we indicated that neither the CDC nor any other
recognized authority known to us had determined a BMI for adults that
would be consistent with listing-level severity weight loss. However,
since that time, we determined that we could establish a BMI comparable
to the severity standard in the weight charts. We established this BMI
level in the final listing by calculating the BMI for each value on
proposed weight tables I and II and averaging them.
We are changing to the more widely used BMI for several other
reasons. For example, this change eliminates the need for gender
tables, as BMI is not gender-specific in adults. Also, we were not able
to apply the prior and proposed weight tables to individuals whose
height was outside the table values, and instead had to review the
evidence and determine whether the impairment medically equaled the
listing. Now we can apply the BMI formula to all cases regardless of
the individual's height. Also, our use of BMI in this body system is
consistent with our use of BMI in Social Security Ruling 02-1p, Title
II and XVI: Evaluation of Obesity (67 FR 57859).
Listing 5.09--Liver Transplantation
In the NPRM, we proposed to add listing 5.09 for liver
transplantation. However, we published final rules adding this listing
on April 24, 2002 (67 FR 20018) based on another NPRM in which we had
also proposed to add this listing. (See 65 FR 6934.) Therefore, in
these final rules, we are retaining the listing we published in April
2002, revising it to include the phrase ``1 year following the date of
transplantation,'' and changing the punctuation to make it easier to
read. The only public comments we received about this listing agreed
that we should add it.
How are we changing the introductory text to the listings for
evaluating digestive disorders in children?
105.00 Digestive System
As in the adult rules, we are revising the introductory text to the
digestive system in part B, final 105.00, to provide additional
guidance for adjudicating digestive disorders. Where necessary, we are
adding information specific to children; however, we are repeating much
of the introductory text of final 5.00 in final 105.00. This is
because, for the most part, the same basic rules for establishing and
evaluating the existence and severity of digestive disorders in adults
also apply to children. We are making a number of changes from the NPRM
in the final rules to make part B even more consistent with part A than
we originally proposed. As we note below, we are also adding:
Listing 105.02 for gastrointestinal hemorrhaging from any
cause requiring blood transfusion;
Listing 105.05A for hemorrhaging from esophageal, gastric,
or ectopic varices, or from portal hypertensive gastropathy;
Listings 105.05C, D, and E for complications of chronic
liver disease;
Listing 105.05F for hepatic encephalopathy;
Listing 105.05G for end stage liver disease with SSA CLD
and SSA CLD-P score criteria;
Listing 105.05H for extrahepatic biliary atresia;
Listing 105.06 for inflammatory bowel disease;
Listing 105.07 for short bowel syndrome; and
Listing 105.10 for the need for supplemental daily enteral
feeding via a gastrostomy.
The following discussions describe only the significant provisions
that are unique to the childhood rules or that require further
explanation. We do not note differences like the fact that we use
references to childhood listings instead of adult listings or that we
use references to ``children'' instead of adults.
[[Page 59405]]
105.00A--What kinds of disorders do we consider in the digestive
system?
Final 105.00A corresponds to final 5.00A, except that we are adding
information to explain that under the childhood listings we also
consider congenital abnormalities involving the organs of the
gastrointestinal system.
105.00B--What documentation do we need?
The only substantive difference between final 105.00B and final
5.00B is a statement noting that we may also need assessments of a
child's growth and development.
105.00D--How do we evaluate chronic liver disease?
The new guidance on chronic liver disease in final 105.00D
generally corresponds to the information in final 5.00D in the adult
rules, except for information specific to the complications of chronic
liver disease in children and two sections (final 105.00D11b and
105.00D12) that are not in part A because they provide guidance for
listing criteria that are only in the final childhood rules.
In final 105.00D11b, we provide information about the SSA Chronic
Liver Disease--Pediatric (SSA CLD-P) calculation, which we use under
final listing 105.05G2 for children who have not attained age 12. We
explain in final 105.00D11b(iv) that we will not purchase the INR value
required to calculate the SSA CLD-P score because obtaining the
necessary amount of blood to perform this test in small children often
requires an invasive procedure. We further explain that if we do not
have an INR value for a child under 12 within the applicable time
period, we will use an INR value of 1.1 for the SSA CLD-P calculation.
(In final 105.00D11a, we provide the same guidelines about the SSA CLD
calculation as we do in part A because the SSA CLD calculation is
applicable to children age 12 to the attainment of age 18.)
In final 105.00D12, we provide guidance for applying final listing
105.05H for extrahepatic biliary atresia, a congenital disorder of the
liver.
105.00E--How do we evaluate inflammatory bowel disease (IBD)?
Final 105.00E corresponds to final 5.00E. In the NPRM, we proposed
a short section (proposed 105.00F4) on IBD that provided guidance for
evaluating IBD under proposed listing 105.06. As in final listing 5.06
in part A, we have greatly expanded proposed listing 105.06 in these
final rules, so we are also including the more detailed guidance for
evaluating the expanded listing criteria of final listing 105.06 that
we provide in part A for final listing 5.06.
105.00G--How do we evaluate malnutrition in children?
Final 105.00G (proposed 105.00F1) reflects changes we made to final
listing 105.08, Malnutrition due to any digestive disorder. In final
105.00G1, we explain that digestive disorders may result in
malnutrition and growth retardation. We also explain that we document
the presence of a digestive disorder with associated chronic
nutritional deficiency despite prescribed treatment using the
malnutrition criteria in final listing 105.08A.
The malnutrition criteria in final listing 105.08A generally
correspond to the laboratory findings we presented as examples in the
introductory text, proposed 105.00F1(a)(1), F1(a)(2), and F1(a)(4). We
are including them as listing criteria in final listing 105.08A in
response to a public comment.
Final listing 105.08A1 corresponds to proposed 105.00F1(a)(1).
However, we changed the criterion for anemia to a hemoglobin of less
than 10.0 g/dL, rather than less than 8 g/dL, to be consistent with the
anemia criteria elsewhere in these final listings. Final listing
105.08A2 requires low serum albumin levels and corresponds to proposed
105.00F1(a)(2). Final listing 105.08A3 corresponds to proposed
105.00F1(a)(4), except that we added the phrase ``fat soluble'' to
clarify the type of vitamin deficiency we intended. We also removed the
concluding phrase ``despite aggressive medical and nutritional
therapy'' because the introductory paragraph of the listing requires
findings ``despite continuing treatment as prescribed.'' We did not
include as a listing criterion the example of intractable steatorrhea
(malabsorption of dietary fats) quantified by fecal fat excretion that
we had included in proposed 105.00F1(a)(3); most pediatric laboratories
no longer do this type of testing, and steatorrhea will usually result
in the vitamin deficiency we describe in final listing 105.08A3.
In 105.00F1b of the proposed rules, we included a paragraph
discussing Body Mass Index (BMI) measurements. We explained in the
preamble of the NPRM that we proposed to add this discussion because
proposed listing 105.08 included criteria based on BMI measurements.
(See 66 FR at 57015 and 57020.)
We are not including this paragraph in the final rules because,
when we reviewed it, we realized that it did not provide guidance that
would have been useful to the application of final listing 105.08 and
that it could have been confusing for the following reasons:
As in the NPRM, final listing 105.08 includes two criteria
for documenting growth retardation, one for children under age 2 (final
listing 105.08B1) and one for children age 2 and older (final listing
105.08B2). Only final listing 105.08B2 includes a criterion for BMI,
and it refers to the CDC's latest BMI-for-age growth charts or data
files. The language we included in proposed 105.00F1b did not explain
this clearly.
Furthermore, much of the language repeated what the
listing already said, and we believe that the language that was not
redundant of the listing was unnecessary. The first sentence defined in
basic terms how to calculate a BMI; however, it was oversimplified for
children.
The proposed paragraph also referred to the fact that the
CDC has determined that a BMI-for-age less than the fifth percentile
meets its criteria for underweight. However, since the CDC does not
calculate a figure or indicate a cutoff that it judges to be indicative
of malnutrition, this guidance in the proposed rule would not have been
useful for applying final listing 105.08.
In final 105.00G2, which replaces proposed 105.00F1b, we are
providing information that is more relevant to the application of final
listing 105.08B. We explain that we use the most recent growth charts
published by the CDC. In final 105.00G2a, we explain that we use the
CDC's age- and gender-specific weight-for-length charts for children
who have not attained age 2. In final 105.00G2b, we explain that we use
the CDC's gender-specific BMI-for-age charts for children age 2 or
older. In final 105.00G2c, we explain how we calculate BMI, and in
final 105.00G2d we provide the corresponding BMI formulas. Final
105.00G2c and 105.00G2d are the same as final 5.00G2a and 5.00G2b.
105.00H--How do we evaluate the need for supplemental daily enteral
feedings via a gastrostomy?
Final 105.00H is a new section that provides guidance for
evaluating the need for feeding gastrostomies for children under age 3
under final listing 105.10. We had previously provided for a finding of
functional equivalence for children under age 3 who require a
gastrostomy for feeding in Sec. 416.926a(m)(10). We are now making
that example of functional equivalence a listing and removing the
example from Sec. 416.926a(m).
[[Page 59406]]
105.00I--How do we evaluate esophageal stricture or stenosis?
Final 105.00I corresponds to proposed 105.00F3 and includes minor
editorial changes for clarity. In this section, we provide guidance for
evaluating esophageal stricture or stenosis, which we had listed in
prior listing 105.03, a listing we are removing because it is a
reference listing. In the final rule, we explain that these conditions
may be evaluated under listing 105.08 or 105.10. We also provide
guidance for adjudicating these conditions when they do not meet a
listing but the child still has problems maintaining nutritional
status.
105.00K--How do we evaluate impairments that do not meet one of the
digestive disorder listings?
Final 105.00K corresponds to final 5.00I, except that we include
two additional examples of digestive impairments relevant to children
that we would evaluate in other body systems. These are the same
additional examples we included in proposed 105.00E1; however, we made
minor editorial changes to these examples for clarity.
How are we changing the listings for evaluating digestive disorders in
children?
105.01 Category of Impairments, Digestive System
Removal of Redundant or Reference Listings
As in the adult listings, we are removing the following reference
listings and other listings that are no longer appropriate:
105.03--Esophageal obstruction, caused by atresia,
stricture or stenosis, which referred to listing 105.08;
105.05F--Chronic liver disease with chronic active
inflammation or necrosis documented by SGOT persistently more than 100
units or serum total bilirubin of 2.5 mg percent or greater;
105.07B--Chronic inflammatory bowel disease with
malnutrition, which referred to listing 105.08; and
105.07C--Chronic inflammatory bowel disease, with growth
impairment as described under the criteria in 100.03. However, we are
adding material to the introductory text in final 105.00G2 to address
the assessment of growth retardation that is secondary to any digestive
disorder.
Prior listing 105.05E, for hepatic encephalopathy, was a reference
listing, referring to listing 112.02 for organic mental disorders. For
the reasons we cited in our discussion of prior listing 5.05E (final
listing 5.05F) above, we are including criteria for evaluating hepatic
encephalopathy in the digestive listings, final listing 105.05F,
instead of evaluating this impairment under the criteria for organic
mental disorders. We will also evaluate the impairment in prior listing
105.05D, hepatic coma, under final listing 105.05F.
The following is a detailed explanation of the changed listing
criteria where they differ from the part A listings.
Listing 105.02--Gastrointestinal Hemorrhaging From Any Cause, Requiring
Blood Transfusion
Final listing 105.02, which corresponds to final listing 5.02, was
not in the NPRM. We are adding it in response to a public comment
described later in this preamble. The final listing is the same as
final listing 5.02, except for the amount of blood transfused. In final
listing 105.02, we provide a ratio of volume of blood to the child's
weight, which is a more medically appropriate standard for children.
Listing 105.05--Chronic Liver Disease
Final listing 105.05A replaces prior listing 105.05C, chronic liver
disease with esophageal varices. The final listing is the same as final
listing 5.05A, except for the amount of blood transfused. As in final
listing 105.02, we provide a ratio of volume of blood to the child's
weight, which is a more medically appropriate standard for children.
Final listings 105.05C, D, E, F, and G correspond to final listings
5.05C, D, E, F, and G in part A, with appropriate changes to reflect
findings and laboratory values for children. Also, final listing
105.05G includes both an SSA CLD score criterion for children age 12
and older (final listing 105.05G1) and an SSA CLD-P score criterion for
children who have not attained age 12 (final listing 105.05G2).
We provide that an SSA CLD-P score of 11 or greater meets the
listing. We chose this score based on the clinical severity represented
by the values contained in the SSA CLD-P score, which we believe
represents the degree of severity consistent with listing level
severity.
For final listing 105.05G2, we require two calculations of SSA CLD-
P scores, at least 60 days apart, and the scores must be calculated
within a consecutive 6-month period, consistent with other provisions
in these final rules.
Final listing 105.05H replaces prior listing 105.05A, inoperable
biliary atresia. The new listing requires extrahepatic biliary atresia,
as diagnosed on liver biopsy or intraoperative cholangiogram. We will
consider children who meet this requirement to be disabled for 1 year
following the diagnosis, and we will evaluate residual liver function
after that period.
Listing 105.06--Inflammatory Bowel Disease (IBD)
We are redesignating prior listing 105.07, chronic inflammatory
bowel disease, as final listing 105.06 for consistency with the
corresponding adult listing. Final listing 105.06 is the same as final
listing 5.06, except that it does not include a criterion for weight
loss from baseline. This criterion is inappropriate for children
because they are continually growing, and therefore do not have a
``baseline weight.'' (We can evaluate weight loss, inadequate growth,
and malnutrition secondary to IBD under final listing 105.08.)
Proposed listing 105.06B required IBD with perineal or intra-
abdominal complications, such as abscess, fistulae, or fecal
incontinence. These complications must have been intractable despite
medical or surgical treatment, and clinically documented over a 6-month
period. Final listing 105.06 includes a criterion for perineal disease
with draining abscess or fistula. However, we did not include fecal
incontinence because final listing 105.06 includes a much wider array
of complications resulting from IBD and children with listing-level
impairments who have fecal incontinence would be evaluated under
criteria in final listing 105.06.
Listing 105.07--Short Bowel Syndrome (SBS)
This new listing is the same as final listing 5.07 except that it
applies to children. It eliminates the need for a finding of functional
equivalence for children of any age who have a frequent need for a
central venous alimentation catheter, as we described in the example of
functional equivalence in prior Sec. 416.926a(m)(3).
Listing 105.08--Malnutrition Due to Any Digestive Disorder
Final listing 105.08 corresponds to proposed listing 105.08;
however, as we have already noted, we are including as listing criteria
three of the examples of laboratory findings that would confirm chronic
nutritional deficiency we had included in proposed 105.00F1a. We also
removed the statement from proposed listings 105.08A and B that the
required findings are ``expected to persist for at least 12 months,''
because it is unnecessary. Under our general
[[Page 59407]]
rules for evaluating disability, an impairment must meet the duration
requirement.
Final listing 105.08 is consistent with the weight-for-length and
BMI-for-age charts and data file tables from the CDC. According to the
CDC, these are the recommended measurements to determine if an
individual's weight is appropriate for his or her height. On May 30,
2000, the CDC updated its 1977 weight-for-length growth charts, and
introduced BMI-for-age charts and tables.\1\ The CDC explained that:
\1\Centers for Disease Control and Prevention, National Center
for Health Statistics. CDC growth charts: United States. May 30,
2000.
These BMI-for-age charts were created for use in place of the
1977 weight-for-stature charts. BMI * * * is used to judge whether
an individual's weight is appropriate for their height. * * * The
new BMI growth charts can be used clinically beginning at 2 years of
---------------------------------------------------------------------------
age, when an accurate stature can be obtained.
As we have already noted, the CDC also defines ``underweight'' in
children as a BMI-for-age less than the fifth percentile, but neither
the CDC nor any other recognized expert authority has published
guidelines for the classification of malnutrition based on BMI.
Therefore, we will continue to monitor this area, and in the meantime,
continue to use our criterion of persistence of weight below the third
percentile to show listing-level severity based on malnutrition for
children under 2 years of age. The third percentile is generally
accepted as the lower limit of the normal range for most biologic
measurements, and persistence below this level would warrant evaluation
and intervention. Likewise, since the current BMI-for-age charts
provide percentiles, we will continue to use measurements below the
third percentile as the listing-level criterion for children age 2 and
older.
In response to a comment, we revised proposed listing 105.08B to
indicate that we use the latest editions of the CDC's charts, which
will ensure that the listing remains current if the CDC revises its
charts in the future.
Listing 105.10--Need for Supplemental Daily Enteral Feeding via a
Gastrostomy
In response to a public comment, we are adding final listing 105.10
for the need for a feeding gastrostomy. Because of this new listing, we
no longer need the functional equivalence example in prior Sec.
416.926a(m)(10) for a gastrostomy in a child who has not attained age
3. We are also clarifying that the gastrostomy must be used for
supplemental enteral feeds on a daily basis.
Conforming Changes
Listing 6.02--Impairment of Renal Function
For the reasons discussed in the explanation of changes for listing
5.08, Weight loss due to any digestive disorder, we are also revising
listing 6.02C4 to use BMI. We are also removing the criterion for
``recent'' weight loss and replacing it with the same criterion we use
in the final digestive disorder listings, a requirement for two
measurements at least 60 days apart within a 6-month period.
Section 416.924b--Age as a Factor of Evaluation in the Sequential
Evaluation Process for Children
We are correcting the reference in the last sentence of Sec.
416.924b(b)(3), which should refer to the functional equivalence
examples in Sec. 416.926a(m)(7) or (8) but incorrectly designates this
functional equivalence rule as Sec. 416.924a rather than Sec.
416.926a. Also, because we are removing two of the examples of
functional equivalence, Sec. Sec. 416.926a(m)(3) and (10), and
redesignating the remaining examples as explained below, we are
revising the reference to refer to final Sec. 416.926a(m)(6) or (7).
Section 416.926a--Functional Equivalence for Children
We are removing paragraph (m)(3), the example of functional
equivalence based on a frequent need for a life-sustaining device at
home or elsewhere, because we are including the need for a central
venous alimentation catheter as final listing 105.07 and because we now
no longer need this functional equivalence example.
We are also removing paragraph (m)(10), the functional equivalence
example of gastrostomy in a child who has not attained age 3, as it is
now final listing 105.10.
Other Changes
We made many editorial changes from the NPRM for clarity in these
final rules. For example, we:
Revised many sentences to put them into active voice, to
simplify them, and to use more consistent style throughout the final
rules;
Reorganized some paragraphs into a more logical order;
Clarified several headings;
Eliminated some redundancy from the proposed provisions;
and
Revised language for greater consistency between part A
and part B.
Also, many of the paragraph designations in the NPRM were different
from the way we designate paragraphs in our other body system listings.
We changed those designations so they are in the same format as our
other listings sections. None of these changes are substantive.
Public Comments
In the NPRM we published in the Federal Register on November 14,
2001 (66 FR at 57009), we provided the public with a 60-day comment
period. The comment period ended on January 14, 2002. In response to
that NPRM, we received letters, telefaxes, and e-mails from 11
commenters containing comments pertaining to the changes we proposed.
The commenters included physicians, advocates for individuals who have
disabilities, individuals who have digestive disorders, and State
agencies that make disability determinations for us.
On November 8, 2004, we published a limited reopening of the
comment period of the NPRM in the Federal Register (69 FR 64702) to
request additional comments about our proposals to revise and remove
chronic liver disease listings. We published this limited reopening of
the comment period because we believed those proposals were
significant. The comment period also lasted 60 days and ended on
January 7, 2005. In response to this reopening, we received letters,
telefaxes, and e-mails from 539 commenters pertaining to the changes we
proposed regarding chronic liver disease. The commenters included
physicians, advocates for individuals who have chronic liver disease,
individuals who have chronic liver disease, and State agencies that
make disability determinations for us.
In addition, on November 17, 2004, during the reopened comment
period, we held an outreach meeting in Cambridge, Massachusetts. At the
outreach meeting, physicians, advocates for individuals with liver
disorders, and individuals who have liver disorders provided additional
comments about chronic liver disease which we included in the
rulemaking record for these final rules.
We carefully considered all of the written comments in response to
the two Federal Register documents and the comments we received at the
outreach meeting. Because some of them were long and many comments were
similar, we have condensed, summarized, and paraphrased them below. We
have tried to present all views adequately and to respond to all of the
issues raised by the commenters that were within the scope of these
rules. We provide our reasons for adopting or not adopting the
[[Page 59408]]
recommendations in the summaries of the comments and our responses
below.
Proposed 5.00A and 105.00A--What kinds of disorders do we consider in
the digestive system?
Comment: A commenter who has a colostomy asked us to include
colostomies in our listings. He described the problems he had been
having with his colostomy.
Response: We did not adopt the comment. Although we agree with the
commenter that some people who have colostomies are unable to work, we
did not add a listing for this because the vast majority of people who
have colostomies do not experience long-term complications that would
meet the 12-month duration requirement and they are able to work.
However, we did include a statement in final 5.00E4 indicating that if
an individual is not able to maintain nutrition due to surgical
diversions of the intestinal tract, including ileostomy and colostomy,
we will evaluate the impairment under listing 5.08.
Proposed 5.00B and 105.00B--What documentation do we need?
Comment: Several commenters expressed concerns about our statement
in the first sentence of proposed 5.00B1 and 105.00B1 that we usually
need longitudinal evidence covering a period of at least 6 months of
observations and treatment, unless we can make a fully favorable
decision without it. One commenter was concerned that the proposed
requirement was overly burdensome, especially for low-income claimants
and the homeless who are unable to access health care. This commenter
noted that proposed 5.00B2 (incorrectly designated as 5.00B3 in the
NPRM) provided guidance for considering medical equivalence when an
impairment did not meet a listing, but was concerned that adjudicators
might overlook that guidance because it was in a separate paragraph.
The commenter was also concerned that administrative law judges would
need more testimony from medical experts to consider the issue of
medical equivalence. The commenter asked us to provide more
alternatives for claimants who, through no fault of their own, are
unable to access continuous health care treatment.
Some commenters stated that adjudicators may consider the 6-month
requirement for observation and treatment absolute and not read the
introductory text in proposed sections 5.00B3 and 105.00B2. The
commenters believed that the proposed provision would require our
adjudicators to defer the adjudication of significant numbers of cases
with documented impairments of the digestive system until there was 6
months of evidence, even when it was obvious that those disorders were
not of listing-level severity. These commenters believed that many
digestive disorder cases could be fairly evaluated after 3 months of
treatment and that we could give adjudicators more room for judgment.
One commenter also suggested that we combine a requirement for 3 months
of treatment with the establishment of a ``medical improvement
expected'' diary in appropriate cases, in order to reflect advances in
medical treatment and the fact that some individuals will respond to
treatment.
Many commenters noted that there are some conditions that are
irreversible or progressive and would not require a 6-month observation
period since the likelihood of substantial improvement with these
conditions is negligible.
Response: In response to these comments, we reorganized proposed
5.00B1 and 105.00B1 and removed the sentence stating that we usually
need evidence covering a 6-month period of observations and treatment.
We did not mean to imply that we would require evidence of 6 months of
observation and treatment for all cases involving digestive disorders.
We agree with the commenters that some digestive disorders are
irreversible and progressive and could be fairly evaluated after 3
months of treatment, or even less. For example, final listing 5.02 does
not require 6 months of evidence if the 3 required hemorrhages and
transfusions occur in less than a 6-month period, as long as the
transfusions are at least 30 days apart; and listing 5.05A requires
only one episode of bleeding varices that require blood transfusion. In
response to comments, we also added three new listings for chronic
liver disease (final listings 5.05C, D, and E) that can be satisfied
with documentation of the required findings on only one occasion.
We recognize that some individuals may not have access to ongoing
treatment and that, because of this, they may not be able to
demonstrate that their impairments meet the criteria of listings in
this body system. As we explain in final 5.00C6 and 105.00C6, it may be
necessary to determine whether an individual's impairment or
impairments medically equal a listing or are disabling based on
consideration of residual functional capacity. We do not believe that
adjudicators will overlook this guidance in the introductory text
because it reflects general adjudicative policy that applies to all the
body system listings. Also, our adjudicators are well aware that they
are required to consult the information in the introductory text when
they apply the listings. We will also provide training for our
adjudicators on these rules.
It may be possible that administrative law judges (ALJs) will need
to consult with medical experts somewhat more frequently than they did
under the prior listings, but we do not believe that there will be a
large increase in this need. We expect that most cases that would have
met prior digestive disorder listings and that will not meet any of the
final listings will require an individualized residual functional
capacity assessment and will not require such expert medical input to
determine whether the individual's impairment medically equals a
listing.
Comment: Another commenter noted that, while many homeless
individuals infected with hepatitis C virus (HCV) do not have medical
records that reflect a complete longitudinal history of medical
treatment, they may have some medical evidence. The commenter said that
we should contact the treating physicians instead of purchasing
consultative examinations. The commenter expressed the view that a
consultative examiner may not be familiar with treating people with
HCV, especially those who are homeless. The commenter indicated that
SSA could save financial resources and secure better evidence for use
in evaluations if all community medical sources were contacted.
Response: We make every reasonable effort to secure evidence from
individuals' treating physicians and other medical sources. Sections
404.1512 and 416.912 of our regulations require us to make every
reasonable effort to obtain a complete medical history from an
individual's medical sources. However, the regulations also explain
that we will order a consultative examination if the information we
need is not readily available from the records of the individual's
medical sources or if we are unable to obtain clarification from the
medical sources.
Proposed 5.00C and 105.00C--How do we evaluate digestive disorders
under listings that require persistent or recurrent findings?
Comment: One commenter stated that our requirement that a
``recurrent'' or ``persistent'' finding must have lasted or be expected
to last for 12 months is medically inappropriate for decompensated
cirrhosis because continued deterioration is expected. The commenter
also indicated that three events within a 6-month period with 1
[[Page 59409]]
month between events is medically inconsistent with the natural history
of chronic liver disease because the disease is chronic and, therefore,
progressive. The commenter acknowledged that some individuals with
chronic liver disease experience episodes of symptoms and signs, but
said that we should not have episodic requirements alone for the
evaluation of the condition.
Response: We agree with the commenter that we do not need episodic
requirements or evidence of persistence for all cases involving chronic
liver disease. Based on this and other comments, we removed proposed
5.00C and 105.00C and added final listings 5.05C through 5.05G. By
making these changes, we provide additional criteria that are
appropriate for evaluating the impairments of individuals who have
progressive, chronic liver disease. Final listings 5.05A, 5.05C, 5.05D,
and 5.05E provide for a determination of disability based on findings
on a single occasion. On the other hand, final listings 5.05B, 5.05F,
5.05G, and 5.08 include conditions that may be acute or chronic and
that may respond to treatment. They contain requirements for episodes
of symptoms and signs.
Proposed 5.00D and 105.00D (final 5.00C and 105.00C)--How do we
consider the effects of treatment?
Comment: One commenter suggested that we discuss how the side
effects of medication can affect a child's growth and social
development. Another commenter noted that treatment side effects can be
debilitating and can cause functional limitations that validate
disability. The commenter recommended that we expand our system of
disability evaluation to acknowledge and articulate how treatment can
affect a child's physical, emotional, and social development, including
specifying how these factors (including school performance) should be
evaluated. This commenter said that we should integrate all aspects of
functional development into the evaluation criteria.
Response: We did not adopt these comments because we believe that
these final rules and our other rules sufficiently address issues of
developmental delay and other potentially adverse effects of treatment.
These final rules include general guidance to our adjudicators in final
105.00C about assessing any adverse effects of treatment. Final
105.00D4 includes a detailed discussion of the effects of treatment for
chronic viral hepatitis infections, including hepatitis B and C virus.
We explain that treatment for chronic viral hepatitis infections will
vary considerably due to a child's age, medication tolerance, treatment
response, and duration of the treatment. While we do not include the
specific example of effects on ``development'' recommended by the first
commenter, we do include a number of other examples of more common
adverse effects of treatment in children.
In addition, we have other rules for evaluating disability in
children, and these rules address the kinds of issues raised by both
commenters. In Sec. 416.924a(b)(9) of our regulations, we include a
detailed explanation of how we consider the effects of treatment in
children. This section explains that we consider, among other things,
any functional limitations that are caused by the side effects of
treatment and the frequency of the need for treatment; in the latter
case, we explain that frequent therapy may interfere with a child's
participation in typical daily activities, which implicitly can also
affect development. Likewise, in Sec. 416.926a we include additional
guidance explaining that we consider limitations that result from
treatment when we make determinations about functional equivalence (see
Sec. 416.926a(a)). In the sixth domain of functioning, ``health and
physical well-being,'' we consider the cumulative physical effects of
physical or mental impairments and their associated treatments or
therapies on a child's functioning (see Sec. 416.926a(1). We also
explain that medications and other treatments a child receives may have
physical effects that also limit his or her performance of activities
(see Sec. 416.926a(a)(3)).
Comment: One commenter disagreed with the proposed guidance on
parenteral and specialized enteral nutrition. The commenter stated that
individuals who have intravenous or gastrostomy tubes require special
equipment and frequently require multiple feedings a day that may
entail a significant amount of time. In the commenter's opinion, this
is so intrusive that individuals who require parenteral or specialized
enteral nutrition to avoid debilitating complications of a disease
should be considered not able to work, and disability should be
established if the 12-month duration requirement has been, or is
expected to be, met.
Response: We partially adopted the comment. There is a wide range
in the nature and severity of underlying diseases that require
parenteral or supplemental enteral nutrition, the type of delivery and
scheduling of administration of such nutrition, and potential related
complications. Many individuals who receive home parenteral or
supplemental enteral nutrition have a reasonably normal lifestyle,
including regular employment. Therefore, we do not think it appropriate
to presume disability in all individuals who need such treatment; we
must evaluate most situations on a case-by-case basis. However, we did
agree that in certain instances the need for parenteral nutrition can
be disabling. Therefore, we added final listings 5.07 and 105.07 for
short bowel syndrome when post-operative nutritional needs cannot be
met orally and an individual requires daily parenteral nutrition via a
central venous catheter. We also added a criterion based on the need
for daily enteral nutrition via a gastrostomy or daily parenteral
nutrition via a central venous catheter in final listings 5.06 and
105.06 for IBD.
As a consequence of the changes we made in response to this
comment, we are also removing two of the examples of functional
equivalence in Sec. 416.926a(m). Section 416.926a(m)(3) provided for a
finding of functional equivalence for children of any age who have a
frequent need for a life-sustaining device, ``e.g., central venous
alimentation catheter.'' Section 416.926a(m)(10) provided for a finding
of functional equivalence for children who have not attained age 3 and
who have a gastrostomy. Therefore, in these final rules, we are
removing functional equivalence examples (m)(3) and (m)(10) because we
no longer need them, as we explained earlier in this preamble.
If we determine that the impairment does not meet or medically
equal one of these listings, we will consider the need for parenteral
or supplemental enteral nutrition via a gastrostomy in our residual
functional capacity assessment or functional equivalence determination,
especially in the kinds of situations described by the commenter. For
example, the functional equivalence domain for children called ``health
and physical well-being'' requires us to consider the cumulative
physical effects of physical or mental impairments and their associated
treatments or therapies on the child's functioning (see Sec.
416.926a(l)).
Proposed 5.00F and 105.00F--What are our guidelines for evaluating
specific digestive disorders? (Final 5.00D and 105.00D--How do we
evaluate chronic liver disease?)
Comment: Several organizations made suggestions for specific
language changes to the introductory text of the
[[Page 59410]]
listings (proposed 5.00 and 105.00). Many commenters asked us to expand
our discussion of the signs, symptoms, and complications of chronic
liver disease. They asked us to list symptoms, such as chronic fatigue,
chronic indigestion, diarrhea, constipation, and sleep disturbances.
Commenters also proposed that we add specific laboratory findings to
the introductory text, such as decreased platelets and acid-base
imbalances. They suggested that we should take into account the
frequency of extrahepatic manifestations resulting from chronic liver
disease and factor them into the medical evaluation.
Response: We partially adopted these comments by expanding the
introductory text to provide additional adjudicative guidance on
symptoms and signs of chronic liver disease. We are providing general
information on symptoms and signs in final 5.00D3 and 105.00D3, and,
where appropriate, specific information about symptoms and signs of
particular chronic liver diseases. For example, in final 5.00D4c(ii)
and 105.00D4c(ii), we provide examples of symptoms associated with the
adverse effects of treatment for chronic hepatitis C virus infection,
and in final 5.00D4d and 105.00D4d, we also provide examples of
extrahepatic manifestations of chronic viral hepatitis by body system.
We did not adopt all the specific language commenters requested because
certain symptoms, such as indigestion, diarrhea, and constipation, are
generally not features of chronic liver disease. However, we did
include in final 5.00D3c and 105.00D3c decreased platelet count in the
list of laboratory findings associated with chronic liver disease, and
we indirectly referenced acid-base imbalances by adding increased
ammonia levels as another laboratory finding.
Comment: One commenter suggested that we add the phrase ``or the
remainder of an individual's natural life'' to the first sentence of
proposed 5.00F2 (final 5.00D1). This sentence described chronic liver
disease and explained that it persists for more than 6 months and is
expected to continue for at least 12 months.
Response: We did not adopt the comment. The issue in our initial
disability determinations and decisions under the listings is whether
the individual has an impairment that prevents him or her from engaging
in any gainful activity (or in a child, that causes ``marked and severe
functional limitations'') and that has lasted or can be expected to
last for a continuous period of 12 months or that is expected to result
in death. We are required by law to reevaluate the disability status of
all individuals who qualify for disability benefits and this applies
even to people who have permanent impairments. Therefore, there would
be no practical reason for us to add the phrase requested by the
commenter.
Comment: One commenter recommended that we delete the word
``function'' in proposed 5.00F2d and 105.00F2e when referring to liver
tests because liver enzymes are not liver function tests.
Response: We adopted the comment in final 5.00D3c and 105.00D3c.
Comment: One commenter suggested we delete the word ``minimal''
when referring to ascites in proposed 5.00F2(d) and 105.00F2(e) (final
5.00D6 and 105.00D6) and that we change it to ``small volume.'' The
commenter also suggested that we delete ``and not on physical
examination'' in this same section to more clearly indicate that we are
referring to incidental and clinically insignificant findings of
ascites found on imaging studies alone.
Another commenter indicated that ascites should be evident on
physical examination and not identified solely by an imaging procedure
that might show clinically insignificant findings of ascites. This
commenter also suggested listing criteria based on intractable ascites,
documented on physical examination as moderate to severe, or
hydrothorax, poorly controlled by or unresponsive to diuretic
treatment, or requiring paracenteses for control.
Response: We agree with the commenters that current imaging
techniques are capable of detecting even minimal amounts of ascites
before detection may be possible on physical examination. However, the
criteria of proposed listings 5.05B2 and 105.05B2 did not base severity
solely on the presence of ascites detected by physical examination or
by imaging studies; nor do these final listings. To meet the severity
requirement, the laboratory findings in final 5.05B2 and 105.05B2 must
also be present. If the laboratory findings are at the level specified
in the listing, it is not necessary to quantify the ascites because
there will be sufficient information to show that the individual is
disabled. Therefore, we did not adopt the comment to change the
quantifier from ``minimal'' to ``small volume'' ascites; instead, we
removed it.
We adopted the second commenter's suggestion to include criteria in
final listing 5.05B and 105.05B for hydrothorax because ascitic fluid
can collect in the chest cavity and result in a very serious
impairment. We did not adopt the other recommendation that we
characterize listing-level ascites as ``moderate to severe,'' because
these terms are subject to varying interpretations and their use would
not promote consistent adjudication.
Comment: One commenter suggested that we provide detailed
information about a number of extrahepatic manifestations and
complications of chronic liver disease and suggested additional
language for proposed 5.00F (final 5.00D).
Response: Based on this and other comments, we added language in
final 5.00D7 through D11 and the corresponding paragraphs in 105.00.
These sections provide guidance relevant to the application of the new
listings we are adding for complications of chronic liver disease; that
is, final listings 5.05C through G and 105.05C through H. We also
provide information on extrahepatic manifestations of hepatitis B and C
in final 5.05D4d and 105.05D4d. The additional information we provide
is relevant only to application of the listings, and therefore, does
not include the amount of detail this commenter suggested.
Comment: Several commenters requested that we provide a listing for
individuals placed on a liver transplant list. They submitted proposals
for the introductory text to explain this suggested listing.
Response: We did not adopt the suggestion of placement on a liver
transplant list alone as a listing because the threshold criteria for
placement on a transplant list vary widely throughout the country and
because individuals may be placed on a list well before they have
listing-level impairments. However, based on this and other comments we
added final listings 5.05G and 105.05G for end stage liver disease
documented by particular scores determined using the SSA Chronic Liver
Disease (SSA CLD) calculation and SSA Chronic Liver Disease-Pediatric
(SSA CLD-P) calculation. We based these calculations on the Model for
End Stage Liver Disease and the Pediatric End Stage Liver Disease (MELD
and PELD) scales that were developed by the United Network of Organ
Sharing for prioritizing patients waiting for liver transplants based
on statistical formulas for predicting mortality from liver disease.
Comment: One commenter noted that liver patients regularly have
laboratory studies to track their liver function. Any decline in
function is evident almost immediately and these laboratory studies are
often done bi-weekly, or weekly in some cases. The commenter said that
we should be able to use the laboratory findings rather than wait until
a patient's condition declines to
[[Page 59411]]
the point that he or she needs a liver transplant.
Response: We partially adopted the comment. Although we have
indicated that laboratory studies may not be a good indicator of
disability, since there may be a poor correlation between the studies
and the severity of liver disease, we believe that some laboratory
findings can be indicative of listing-level severity for certain
disorders, such as spontaneous bacterial peritonitis (final listings
5.05C and 105.05C), hepatorenal syndrome (final listings 5.05D and
105.05D), hepatopulmonary syndrome (final listings 5.05E and 105.05E),
and end stage liver disease (final listings 5.05G and 105.05G).
Final Listing 5.02--Gastrointestinal Hemorrhage From Any Cause,
Requiring Blood Transfusion
Comment: Proposed listing 5.02 specified that at least 2 units of
blood must be transfused per episode. One commenter expressed concern
that different physicians and different religious preferences can
dictate when and how much blood is transfused. The commenter said that
it appeared more reasonable to use hematocrit levels, which are
standardized, instead of a more subjective and less standardized method
based on the number of units transfused.
Response: We did not adopt the comment to use a hematocrit level in
this listing because it takes time for the hematocrit to equilibrate
following rapid blood loss. We also did not adopt the comment to remove
the 2-unit requirement for the amount of blood transfused per episode
in final listing 5.02. As we explained earlier, we chose 2 units of
blood because this is the minimum amount of blood that is usually
transfused.
We recognize that there are individuals who may object to
transfusions. In such cases, their impairments cannot meet the
requirements of any listing that includes a criterion for a
transfusion. However, it is certainly possible for a person who refuses
transfusions to be found disabled under our other rules for determining
disability.
Comment: One commenter noted that in proposed listing 5.02 we
stated that all incidents within a consecutive 14-day period constitute
one episode, but in proposed 5.00C2 we also stated that there must be
at least 1 month between events (incidents). The commenter asked us to
clarify these requirements because it seemed that all events within a
30-day period should constitute one episode.
Response: We clarified the requirements by deleting the sentence in
proposed listing 5.02 that referred to episodes within a 14-day period
because it could have been confusing and was not necessary for
correctly applying the listing. Although our intent was to explain that
several bleeds may occur during a single episode, listing-level
severity is based on hemorrhages that require transfusions and not the
actual number of bleeds per episode. We require 30 days between
hemorrhages that require transfusion in order to establish that there
are separate events and that the condition is chronic.
Final Listings 5.05 and 105.05--Chronic Liver Disease
Comment: One commenter recommended that we place the study
``endoscopy'' before ``x-ray'' in listing 5.05A because 95 percent of
diagnoses for varices are made by endoscopy.
Response: We adopted the comment.
Comment: We received many comments asking us to change the headings
of listings 5.05 and 105.05. Commenters suggested eliminating the words
``and cirrhosis of any kind,'' stating that ``cirrhosis'' is chronic
liver disease. Commenters also pointed out that individuals may have
chronic liver disease but not necessarily cirrhosis.
Response: We adopted the comments and removed the reference to
``cirrhosis'' from the headings of the two listings.
Comment: One commenter stated that the definition of cirrhosis can
be subjective. The commenter said that one doctor who reads a tissue
sample may diagnose fibrosis and another doctor may diagnosis
cirrhosis. This commenter stated he had had debilitating symptoms
before he officially had cirrhosis.
Response: We do not agree that the definition of cirrhosis is
subjective. Cirrhosis is a disorder defined by pathology. Fibrosis is
an early form of scarring. Cirrhosis is late-stage disease and readily
distinguishable by pathologists from fibrosis. We do agree, however,
that individuals can have debilitating problems from chronic liver
disease before they develop cirrhosis. As we have noted in a number of
places throughout this preamble, we have expanded and clarified the
final rules to ensure that we identify people without cirrhosis who
should qualify under these final listings.
Comment: Many commenters noted that the proposed changes for
chronic liver disease contained fewer criteria (physical examination,
laboratory, or imaging tests) to establish disability than did the
prior listings. They expressed concern about ``compressing'' prior
listings 5.05 B, C, D, E, and F into proposed listing 5.05B, which
contained only two sets of severity criteria. Some commenters said that
the proposed listings were vague and too narrow in scope. Commenters
believed that this would make our determinations more restrictive and
perhaps erroneous. They urged us to expand the medical evaluation
criteria to more accurately reflect the pathophysiology of chronic
liver disease. The commenters believed that the listings should be more
specific and inclusive with regard to signs, symptoms, complications,
treatment, and metabolic and functional factors to make the evaluation
of chronic liver disease more on par with HIV criteria because
hepatitis C is a systemic illness that encompasses a broad spectrum of
diseases similar to HIV infection.
Response: We adopted many of these comments. We significantly
expanded the listing criteria for chronic liver disease. For example,
we expanded proposed listings 5.05A and 105.05A to include hemorrhaging
from gastric or ectopic varices and portal hypertensive gastropathy. We
also expanded proposed listings 5.05B and 105.05B to include
hydrothorax as well as ascites. We added four listings in parts A and B
based on suggestions from commenters: Final listings 5.05C, D, E, and
G, and 105.05C, D, E, and G. We also replaced the prior reference
listing for hepatic encephalopathy with a stand-alone listing for this
complication of chronic liver disease (final listings 5.05F and
105.05F).
Analogous to the detailed guidance we provide about HIV infection
in 14.00D and 114.00D of our listings, we have greatly expanded the
introductory text to include detailed information on chronic viral
hepatitis infections in final 5.00D4 and 105.00D4. We provide
information about the symptoms, signs, and complications of chronic
hepatitis B and C virus, and include information about the types of
treatment for these infections and the common adverse effects of this
treatment. We have also added information on extrahepatic
manifestations of hepatitis B and C virus by body systems.
We did not add all of the suggested complications or extrahepatic
manifestations of chronic liver disease because most respond to
prescribed treatment and they are generally very rare. Also, some of
the suggested extrahepatic syndromes are multi-causal, may be unrelated
to the liver disease, and poorly correlate with the degree of liver
destruction. Very serious extrahepatic manifestations that we did not
list in these final rules can be
[[Page 59412]]
evaluated under the affected body system. Lesser manifestations are
evaluated in the residual functional capacity assessments or functional
equivalence evaluations later in the appropriate sequential evaluation
process for adults or children. (We describe the sequential evaluation
process later in this preamble.)
Comment: Several commenters suggested we include a classification
system, such as the Child-Turcotte-Pugh score, which has a refined
scoring system and has been validated for years as predictive of
mortality. This score indicates cirrhosis as ``compensated'' and
``decompensated.''
Another commenter suggested that we should not use the Child-
Turcotte-Pugh score because it does not pick up some disabilities, but
we should use the MELD and PELD scoring systems which have replaced it.
Response: We partially adopted the suggestion to use a
classification system by including an SSA CLD score criterion in final
listing 5.05G, and SSA CLD and SSCLD-P score criteria in final listings
105.05G1 and G2. The SSA CLD and SSA CLD-P calculations are based on
the calculations for the MELD and PELD scores, but we made minor
changes to these calculations to make them more appropriate for
determining disability. We did not base the SSA CLD-P calculation on
the Child-Turcotte-Pugh score because it has been superseded by the
PELD in clinical practice.
Comment: Several commenters were concerned about our proposal to
remove prior listing 5.05B, for performance of a shunt operation for
esophageal varices.
One commenter noted there are still problems that can occur with
the TIPS shunting procedure, such as occlusion, infection, or failure.
The commenter noted that TIPS shunting does not have any bearing on the
severity of the condition that required the shunt. The commenter also
indicated that, although the shunt will help relieve the pressure
causing the hemorrhage, it does not bring about a recovery or
improvement of the liver disease itself.
The same commenter stated that, after a TIPS procedure, the blood
is not being filtered by the liver, but is bypassing liver function,
and that blood toxicity is an issue. The commenter noted that TIPS
prevents or postpones the next big bleed, but does not cure the
underlying disease, usually cirrhosis. The debilitating symptoms are
not eliminated and the patient is unable to perform work or normal
lifestyle functions.
Response: We did not adopt the comments asking us to keep prior
listing 5.05B. As we indicated in the preamble to the NPRM, more modern
types of procedures, such as TIPS, are less risky and can be performed
before the condition becomes serious enough to meet the level of
severity required by our listings. Therefore, we cannot presume that
everyone who has had a TIPS procedure is disabled. However, we will
evaluate the severity of the underlying chronic liver disease under
final listing 5.05, and if it does not satisfy the requirements of the
listing, we will evaluate the effects of any debilitating symptoms when
we assess residual functional capacity at later steps in the sequential
evaluation process.
We do agree that complications of TIPS may occur. However, if there
are complications, immediate medical attention would be required, and
the complications would not last or be expected to last for 12 months.
We do not agree with the comment that blood is not being filtered
by the liver after a TIPS procedure. Portal pressure is reduced by the
TIPS procedure, which connects the portal vein to the hepatic vein
using a stent (shunt); however, there is still some blood that filters
through the liver.
Comment: Many commenters disagreed with our proposal to remove
prior listings 5.05E and 105.05E for hepatic encephalopathy. They noted
that this condition is directly related to end stage liver disease and
affects an individual's ability to work due to manifestations such as
confusion, poor memory, and lack of concentration. Many commenters also
recommended that we include criteria for evaluating hepatic
encephalopathy in the digestive disorders listings rather than
evaluating the condition in the mental or neurological body systems.
Another commenter noted that TIPS can cause encephalopathy, and said
that doing away with listings for shunts and hepatic encephalopathy was
not a good idea.
Response: We adopted the comments. Although we are still removing
prior listings 5.05E and 105.05E because they were reference listings
that only referred to the mental disorders listings, we are adding new
listings for hepatic encephalopathy that contain specific evaluation
criteria, final listings 5.05F and 105.05F. These final listings
include criteria for the behavioral or cognitive manifestations of
hepatic encephalopathy in combination with TIPS or any surgical
portosystemic shunt or in combination with a specific clinical or
laboratory finding. We are also providing guidance in final 5.00D10 and
105.00D10 of the introductory text for using the new listings.
Comment: We received many comments regarding the use of liver
biopsies in the evaluation of chronic liver disease. Commenters stated
that individuals with chronic liver disease may suffer from a multitude
of symptoms and have little evidence of injury to their liver, while
others may have few symptoms, even with extensive cell damage on liver
biopsy. Therefore, histological findings may not correlate with
functional capacity. Others noted that extrahepatic manifestations of
chronic liver disease cannot be found on liver biopsy, yet these
manifestations are symptomatic and limiting.
Also, in an apparent reference to our proposal to remove the
requirement for confirmation of chronic liver disease by liver biopsy
in prior listing 5.05F, commenters agreed that a biopsy should not be
mandatory. However, they indicated that the results of a biopsy could
help to assess whether an individual has cirrhosis, particularly early
cirrhosis, since symptoms may not be substantiated by blood tests or
physical examination.
Response: We agree with the commenters that a liver biopsy is
useful in diagnosing cirrhosis, and in final 5.00D3c and 105.00D3c, we
explain that biopsy may demonstrate the degree of liver cell necrosis,
inflammation, fibrosis, and cirrhosis. We also agree with the
commenters that a liver biopsy is not a good predictor of the severity
of symptoms of chronic liver disease or their effect on functioning.
Therefore, as we explained earlier, we have removed prior listing
5.05F, which was based in part on confirmation of chronic liver disease
by liver biopsy. We will continue to consider liver biopsy reports when
they are part of the existing medical records in combination with all
the other evidence in the case record.
Comment: Several commenters stated that many of the medications and
procedures used to treat the symptoms of liver disease, such as higher
dose diuretics, repeated large-volume paracenteses, and placement of
TIPS for bleeding esophageal varices, have side effects that we should
consider. The commenters noted that treatment can lead to major
electrolyte or renal problems.
Response: We agree that the effects of treatment must be considered
in assessing digestive impairments. In final 5.00C and 105.00C, we
provide general guidance for how we consider the effects of treatment
for all impairments in this body system. In final 5.00D4 and 105.00D4,
we provide specific guidance
[[Page 59413]]
about how we consider the effects of treatment for chronic viral
hepatitis infections.
Also, if an impairment does not meet or medically equal a listing,
we continue to consider the effects of treatment on the individual's
ability to function when we assess residual functional capacity, or for
children, when we assess functional equivalence.
Comment: Several commenters suggested that we add documented portal
hypertension to listing 5.05A and 105.05A.
Response: We adopted the comment.
Comment: One commenter suggested that proposed listing 105.05A was
more restrictive than proposed listing 5.02 for adults, with no
corresponding childhood listing 105.02 for children. The commenter
suggested that we include a comparable listing for children based on
three gastrointestinal bleeds requiring transfusion in a 6-month period
due to any disease process, not just esophageal varices.
Response: We adopted the comment and added a corresponding
childhood listing 105.02 with essentially the same provisions as in
final listing 5.02.
Comment: Many commenters recommended that we delete the word
``massive'' from proposed listings 5.05A and 105.05A. They also
suggested including other sites of bleeding besides the esophagus under
listing 5.05A, specifically bleeding from gastric and ectopic varices,
and portal hypertensive gastropathy.
Response: We adopted the comments and made corresponding changes to
final 5.00D5 and 105.00D5 of the introductory text which provide
guidance for applying listings 5.05A and 105.05A. We also changed the
proposed criteria of these listings, as we explain in our response to
the next comment.
Comment: Many commenters opposed the requirement in proposed
listing 5.05A that an individual receive 5 units of blood in order for
his or her impairment to meet the requirement for a massive hemorrhage.
One commenter stated that it would be more reasonable to simply
require a ``significant hemorrhage.'' This commenter noted that any
transfusion is significant.
Another commenter said that specifying the number of units
transfused could not be supported because the size of the individual,
the protocol of the hospital, the timeliness of the intervention, and
other factors could influence the amount of blood transfused. This
commenter doubted that the prognosis for an individual with bleeding
varices who receives 4 units is significantly better than for an
individual who receives 5 units. The commenter thought that, since
physicians and hospitals are reluctant to transfuse blood, any blood
transfusion should suffice or the matter should at least be left to
medical judgment.
Another commenter said that a transfusion of ``multiple'' units of
blood in conjunction with other interventions in an attempt to restore
hemodynamic stability should suffice and that there should be some
latitude for medical judgment in this listing.
Another commenter stated that we should include other criteria to
define a hemodynamically significant bleed, such as at least a 2-unit
bleed, or a drop in blood pressure and increase in pulse rate. This
commenter also suggested changing the wording from ``hemodynamic
instability'' to ``hemodynamically significant bleed'' in the listing
and the introductory text.
Response: We partially adopted the comments. We agree that the
proposed rule was too severe. Therefore, we revised the listing so that
the primary criterion for listing-level severity is hemorrhaging that
results in hemodynamic instability and requires hospitalization for
transfusion. Since the minimum amount of blood a physician will usually
transfuse in adults is 2 units, we used this amount in the listing.
In final 5.00D5, we also adopted some of the language suggested by
commenters to describe hemodynamic instability, including pallor,
diaphoresis, rapid pulse, low blood pressure, postural hypotension, and
syncope. (We also provide brief definitions of the more technical
medical terms on this list.) We do not indicate, as we did in the NPRM,
that hemodynamic instability may require multiple transfusions because
final listing 5.05A requires only one transfusion.
We made similar changes in the part B section for children, but
provided a rule for documenting appropriate transfusion volumes based
on body weight.
Comment: One commenter noted that some people could not meet
listing 5.05A because they may have many large varices clipped. These
individuals would be in serious danger and disabled without ever
bleeding.
Response: We agree that an individual who has had prophylactic
banding of varices without a bleed would not meet the requirements of
final listing 5.05A. However, one of the major complications of
cirrhosis with portal hypertension is bleeding varices; therefore, a
criterion for hemorrhaging is appropriate in these listings. An
impairment that does not meet the requirements of 5.05A because varices
have been clipped may still meet the requirements of final listing
5.05B through 5.05G or be disabling on another basis.
Comment: One commenter stated that the mortality rate associated
with variceal bleeding has decreased over the last several years with
advances in therapy. If an individual goes more than a year without
recurrent bleeding, he or she is back at baseline and has only a 25
percent risk for bleeding. The commenter recommended that we determine
disability at that point by the state of decompensation of the liver
rather than the risk of bleeding.
Response: All of the criteria in final listings 5.05 and 105.05 are
based on the state of decompensation of the liver rather than the risk
of bleeding. The requirement under 5.05A for hemorrhaging that results
in hospitalization and transfusion reflects one of the major
complications of chronic liver disease. When we determine whether an
impairment that met 5.05A continues to be disabling following the 1-
year period of disability, we evaluate any residual impairment(s),
including bleeding and other complications of chronic liver disease.
Comment: One commenter stated that the proposed language for the
length of disability under listings 5.05A and 105.05A (that is, ``for 1
year following the last documented massive hemorrhage'') did not work.
The commenter suggested that the correct standard has to be the state
of decompensation of the liver, not a fixed period of time.
Response: We did not adopt the comment. As we explained in the
NPRM, we changed the period for which we would presume the impairment
is disabling from 3 years to 1 year because of newer techniques in the
treatment of esophageal varices. (See 66 FR at 57013.) The same logic
would hold for other bleeds as well.
Also, it is important to remember that the 1-year rule does not
mean that disability automatically ends 1 year following the last
documented transfusion (we removed the description ``massive
hemorrhage'' as we explained earlier). Our rule is only that after 1
year we must consider whether the impairment is still disabling. Also,
our existing rules allow our adjudicators to decide that we will not
review a case until a date later than 1 year after the qualifying event
(in this case, the last documented transfusion), if the medical
evidence supports a conclusion that the disability will continue for
longer than 1 year.
[[Page 59414]]
Comment: One commenter objected to the criterion in proposed
listing 5.05B2a for a cutoff level for serum albumin depletion, stating
that the actual serum albumin level is dependent upon many factors,
such as hydration and the degree of portal hypertension. The commenter
suggested that we change the listing criterion to ``an associated
decrease in serum albumin.''
Response: We did not adopt the comment. A serum albumin level of
3.5 g/dL is normal. Even though a level between 3.0 g/dL and 3.5 g/dL
may indicate an abnormality, it is does not reflect listing-level
severity. A level of 3.0 g/dL or less is recognized by hepatologists as
indicative of loss of liver biosynthesis.
We set the laboratory values in these listings, such as the serum
albumin level in 5.05B2a, at a level that reflects very serious
impairment because we use the listings only to deem individuals
disabled without considering any other factors that may contribute to
their inability to work; that is, their residual functional capacity,
age, education, and work experience. However, the establishment of
these levels does not mean that individuals whose impairments do not
satisfy the criteria of the listing are not disabled; it only means
that we do not presume that they are disabled under the listing. We may
still find that the impairment is disabling based on an individualized
assessment of its effects on the individual's functioning.
Comment: One commenter suggested that we include a criterion for
malabsorption with involuntary weight loss of 10 percent or more from
baseline in the absence of a comorbid condition that could explain the
findings.
Response: We did not adopt the comment because malabsorption is not
a common feature of chronic liver disease. However, individuals with
chronic liver disease and the appropriate degree of weight loss can
meet the requirements of final listings 5.08 or 105.08.
Comment: Several commenters suggested that we change the measure of
coagulation studies from prothrombin time to International Normalized
Ratio (INR) as many laboratories do not report the prothrombin time in
terms of seconds, but do report the INR.
Response: We adopted the comment.
Comment: Several commenters suggested that we include hepatic
malignancy as a criterion in listings 5.05 and 105.05, noting that many
liver diseases result in hepatocellular carcinoma.
Response: We did not adopt the comment because we already have
listings for malignant tumors of the liver, listing 13.19 for adults
and listing 113.03 for children. However, in response to this comment,
we added a cross-reference to listing 13.19 in final section 5.00D1 and
to listing 113.03 in final section 105.00D1.
Comment: Several commenters stated that some hepatic conditions,
such as Budd-Chiari syndrome, may not include cirrhosis or ascites, but
are disabling and should be included as conditions for determining
eligibility for disability benefits.
Response: We did not add all the specific conditions mentioned by
the commenters to the listings. However, as already explained, we did
add several criteria to final listing 5.05 and 105.05 to expand the
scope of those listings and to address additional manifestations of
chronic liver disease. We also expanded the introductory text in 5.00D2
and 105.00D2 to provide examples of chronic liver disease that should
be considered under the listings when they result in the complications
specified in the listings. We added guidance regarding the effects of
the extrahepatic manifestations of chronic liver disease that should be
considered under the requirements of other body systems or at later
steps in the sequential evaluation process when the impairment does not
meet or medically equal a listing in the digestive disorders body
system.
Comment: One commenter noted that we proposed to remove the
laboratory values from prior listings 5.05C and 5.05F and asked why we
did not propose to delete the laboratory values in proposed listing
5.05B. The commenter recommended that we delete the values from listing
5.05B as well.
Response: We did not adopt the comment. As we explained in the NPRM
(66 FR at 57013) and have explained earlier in this preamble, we did
not propose to delete the laboratory values in proposed listing 5.05B
because they are specific indicators of the severity of the
deterioration of liver function in that listing. Serum albumin level is
a good indicator of liver biosynthesis and it correlates with the
severity of ascites. In addition, blood coagulation disorders resulting
from chronic liver disease are indicative of the severity of the liver
dysfunction. However, as we explained earlier in this preamble, we are
providing a criterion for an elevated INR as a measure of the body's
ability to regulate coagulation, rather than a prolongation of
prothrombin time as in the prior and proposed listing, because INR is a
more widely used study than prothrombin time.
Comment: Another commenter believed that our proposal to eliminate
prior listing 5.05C, which required chronic liver disease with elevated
serum total bilirubin, would be a ``great disservice'' to individuals
with primary biliary cirrhosis (PBC), primary sclerosing cholangitis
(PSC), and autoimmune hepatitis (AIH). The commenter noted that
elevated serum total bilirubin levels and pruritis associated with
these conditions are very real problems. Also, a commenter noted that
most primary care doctors are not going to run studies other than the
serum total bilirubin.
Response: Even though serum total bilirubin studies may be readily
available in the medical records from primary care physicians, we are
removing prior listing 5.05C because, as we explained earlier, this
laboratory finding alone is not a good indicator of impairment severity
or an individual's ability to function. However, serum total bilirubin
is one of the three laboratory values we use to calculate the SSA CLD
score for final listing 5.05G.
In response to this comment, we are providing a list of examples of
chronic liver disease in final 5.00D2. The list includes PBC, PSC, and
AIH, and will remind adjudicators that these conditions can be
evaluated under final listing 5.05.
Comment: One commenter stated that doctors are finding that low
platelet counts are an indicator of portal hypertension and that they
should be added to the criteria for listings 5.05 and 105.05. The
commenter noted that patients are concerned about the amount of
physical activities they can perform with low platelet counts and
abnormal coagulation.
Response: We do not include low platelet counts as stand-alone
criteria for listing-level severity because there is a wide statistical
variation in platelet counts, and there is no specific level at which
individuals will subsequently bleed. We consider any functional
consequences, such as limitations in an individual's ability to perform
physical activity, when we assess residual functional capacity in
adults and functional equivalence in children.
However, in response to this comment, we added a reference to
abnormal coagulation studies, including an increased INR level and
decreased platelet counts, in our list of laboratory studies associated
with chronic liver disease in final 5.00D3c and 105.00D3c. We explain
that elevated INR level does indicate loss of synthetic liver function,
as well as increased likelihood of cirrhosis and associated
complications. We also include an elevated INR level
[[Page 59415]]
in the criteria of listings 5.05B and 105.05B.
Comment: Proposed listings 5.05B and 5.06 contained criteria that
required specific findings to occur during a consecutive 6-month
period. Commenters believed that our proposal to change the requirement
that ascites persist for 5 months in prior listing 5.05D to a
requirement for 6 months in proposed listing 5.05B seemed arbitrary and
unfair because not all impairments fit neatly into 6-month blocks.
(There was no 6-month requirement in prior listing 5.06.) The
commenters believed that we changed the listing simply to coincide with
an arbitrary timeframe without regard for long-held understanding of
medical severity. One commenter believed that the period was excessive
because clinically significant ascites for 3 months despite treatment
represents serious liver disease.
Another commenter questioned how we would handle cases in which the
appropriate findings persist consecutively over a 2- to 5-month period,
improve for a few months, and then recur for a few months. The
commenter asked if a case involving multiple recurring periods, none of
which individually lasts up to 6 consecutive months, could equal either
of these listings.
Response: As we explained in the NPRM, ``[i]n our experience,
requiring 6 months of persistent findings enables us to make a more
reliable prediction of listing-level severity.'' (See 66 FR at 57013.)
Requiring findings from at least two evaluations, at least 60 days
apart, within a consecutive 6-month period allows us to document the
recurrent or persistent nature of many of these impairments and is a
more reliable indicator that the impairment will be disabling for 12
consecutive months. When these listing requirements are satisfied, we
can generally conclude that the impairment will be disabling for 12
consecutive months.
In the two examples provided by the commenters (that is, clinically
significant ascites for 3 months despite treatment, or findings
persisting for 2 to 5 months that improved for a few months and then
recurred), the impairments would meet the listing if there was evidence
showing the required findings on two evaluations spaced at least 60
days apart. These examples show that we do not necessarily need 6
months of evidence to find that an impairment meets the listing. Also,
as we have already noted, if the impairment does not meet the criteria
of any of these final listings, it may meet the criteria of a listing
in another body system, medically equal a listing, or meet the
definition of disability later in the sequential evaluation process.
Comment: One commenter believed that we should not require
documentation of ascites by both physical examination and appropriate
medically acceptable imaging under proposed listings 5.05B2 and
105.05B2. The commenter stated that imaging studies are not always
available and that, if ascites is observable on examination and the
serum albumin or coagulation studies criterion in the listing is
fulfilled, it seems unnecessary to also require documentation by
imaging. Another commenter noted that it is difficult to demonstrate
ascites in obese people by physical examination, and requiring both
types of documentation could reduce the chance that an individual who
is obese would benefit from this listing.
Another commenter stated that our proposed listing 5.05B criteria
did not quantify the amount of ascites and that we should be evaluating
significant ascites.
Response: We adopted the first two comments by providing in final
listing 5.05B2 that ascites or hydrothorax can be demonstrated by
appropriate medically acceptable imaging ``or'' by physical
examination. Since the required laboratory findings in final listings
5.05B2 establish the severity of the impairment under the listings, we
agree that there is no need to require documentation of ascites both on
physical examination and on imaging. Because of this change in the
final rules, individuals with obesity will be able to meet this listing
with ascites demonstrated on imaging techniques alone, provided they
meet the other criteria of the listing.
Because of this comment, we also reviewed the same criterion in
proposed listing 105.05. For consistency, and because it is medically
appropriate, we included the same requirements for children in final
listing 105.05B as we do for adults in final listing 5.05B. We also
restored the criterion from prior listing 105.05B for an associated
serum albumin of 3.0 g/dL or less and added a criterion for an INR of
1.5 consistent with final listing 5.05B. This will ensure that the
ascites is a sign of chronic liver disease.
Because we are requiring the associated laboratory studies with the
ascites to demonstrate listing-level severity, we will not need to
quantify the amount of ascites.
Comment: One commenter recommended that we not delete listing
105.05A, inoperable biliary atresia, and require children to prove
disability in other ways.
Response: We adopted the comment. In final listing 105.05H, we have
clarified that the listing applies only to extrahepatic biliary
atresia, thus excluding other types, such as intrahepatic biliary
atresia. We are no longer using ``inoperable'' to describe the
condition, because by definition, extrahepatic biliary atresia cannot
be remedied with surgery except by liver transplantation; the
portoenterostomy procedure usually performed in the first 3 months of
life is only palliative.
Comment: One commenter believed that our requirement for
prolongation of the prothrombin time of at least 2 seconds in proposed
listing 5.05B2(b) was medically unreasonable and might be excessive.
The commenter suggested that any reading above the normal value for the
reporting laboratory should qualify.
Response: We disagree with the comment; however, we have removed
the proposed criterion for measurement of prothrombin time and instead
provided a criterion for INR in final listing 5.05B2 because INR is a
more widely used study than prothrombin time. As we explained earlier,
because we use the listings to deem individuals disabled, we must set
laboratory values in the listings at levels that reflect very serious
impairment.
Comment: One commenter suggested that we include in listing 105.05
consideration of poor school performance, difficulties in play, and
growth and developmental delays. The commenter gave examples of
developmental delays due to ascites, such as inability to roll over.
Response: We did not include this information in the listing, but
in response to this comment we did note in final 105.00D3 in the
introductory text that the manifestations of chronic liver disease may
include developmental delays or poor school performance. The issues
raised by this comment are more appropriately addressed when we make
functional equivalence determinations under Sec. 416.926a, where we
provide detailed, age-specific guidelines for evaluating limitations in
school, play, and various other developmental issues.
Comment: Many commenters stated that we should include a separate
listing for chronic hepatitis B and C. Some suggested that we do not
recognize the hepatitis C virus as a disability and they believed that
it is ``unacceptable'' to evaluate individuals with chronic hepatitis C
virus under the chronic liver disease listings. Some commenters thought
that our proposals would
[[Page 59416]]
restrict individuals with hepatitis C from receiving benefits. One
commenter said that our proposed changes did not take into account
knowledge gained in the last 20 years regarding the hepatitis C virus.
Some commenters thought we were removing hepatitis C and all liver
diseases from the listings, while others suggested that we wrote the
chronic liver disease listings only for alcoholic and drug-induced
liver failure.
Response: We are not removing chronic liver disease from the
listings, and we do recognize and include hepatitis C, which is a
chronic liver disease, under final listings 5.05 and 105.05.
We believe that the many changes and improvements we are making in
the final listings and the introductory text in response to these and
other comments will make clear that final listings 5.05 and 105.05
apply to all forms of chronic liver disease, including disease caused
by the hepatitis B and C viruses. As we have already explained, final
listings 5.05 and 105.05 are now broader in scope and more inclusive
than the proposed listings were. We did not add a separate listing for
chronic hepatitis B or C because individuals with listing-level effects
of hepatitis will have the same kinds of findings as those associated
with other chronic liver diseases.
In response to these and other comments about chronic viral
hepatitis, we are also adding extensive sections to the introductory
text to address many of the concerns expressed in the comment letters
and at the outreach conference. Final 5.00D4 and 105.00D4, which
explain how we evaluate chronic viral hepatitis, are the longest
sections in the introductory text. We have provided subsections
explaining:
The nature and course of hepatitis B and C infections;
Treatment, including the adverse effects of treatment; and
Extrahepatic manifestations of hepatitis B and C.
With these changes, we believe it will now be very clear that we do
consider hepatitis B and C to be medically determinable impairments
that could be the basis for a finding of disability. We explain how
these impairments can meet the requirements of final listings 5.05 and
105.05, and how they can be disabling in other ways, either by meeting
other listings, medically equaling listings, or based on the functional
consequences of the impairments as a result of symptoms and the effects
of treatment. It should also be clear that we do not intend to restrict
the entitlement to disability benefits of individuals who have
hepatitis B or C; rather, we intend to include everyone who should
qualify under our rules. The new information in final 5.00D4 and
105.00D4 will also ensure that our adjudicators have up-to-date
information about hepatitis B and C.
Comment: Some commenters indicated that the debilitating symptoms
of hepatitis C virus often begin decades before end-stage liver failure
occurs. Some commenters recommended that we include criteria for
hepatitis like the criteria in listings 14.08N and 114.08O, for human
immunodeficiency virus (HIV). Those listings provide for a finding of
disability based on significant documented symptoms or signs with
specified functional limitations. The commenters indicated that the
symptoms and signs of hepatitis, such as decreased cognitive function,
decreased memory acuity, fatigue, weakness, fever, malaise, lethargy,
weight loss, abdominal pain, appetite disturbance, mood disturbance,
and insomnia, are in many respects the same as the symptoms and signs
we include in listings 14.08N and 114.08O. The commenters noted that
both HIV and chronic hepatitis B and C are systemic illnesses that
encompass a broad spectrum of diseases and potential impairments with
many constitutional and systemic signs and symptoms.
One commenter stated that including a listing based on functional
limitations would be important for individuals who are homeless and
whose functional disabilities may be very profound. The commenter noted
that it would be easier to document the functional limitations than the
medical conditions because expert medical care may not be available to
this group.
A group of physicians who spoke at the outreach meeting commented
that they ``struggled with the dilemma of'' how we should evaluate
fatigue because they believe it is subjective and difficult to assess
and validate. They recommended that the assessment of the validity and
impact of fatigue should rest on the judgment of the treating source.
Response: We did not adopt the comments. While we agree that some
individuals with hepatitis B and C may be debilitated by symptoms of
fatigue and the other symptoms mentioned by the commenters, we believe
it would be more appropriate to consider these symptoms on a case-by-
case basis at later steps of the sequential evaluation process, based
on information obtained from the treating source(s) as well as other
medical and non-medical sources concerning the particular effects of
the impairments on residual functional capacity or, for children, age-
appropriate functioning.
Also, we do not believe we should add a functional listing to the
final rules without first proposing it and asking for public comment on
the criteria it might contain. Therefore, even though we are not adding
such a listing now, we plan to issue an Advance Notice of Proposed
Rulemaking inviting public comments on whether we should add a
functional listing to the digestive disorders body system and, if so,
what functional criteria would be appropriate.
With regard to the comment that we should add a listing based on
functional limitations for individuals who are homeless, we do not
believe we should add a listing at this time for the reasons stated
above; however, we do evaluate functional limitations that result from
the symptoms and signs of an impairment when we assess residual
functional capacity.
We agree with the physicians who spoke at the outreach meeting that
the fatigue associated with hepatitis B and C is often substantial but
also difficult to assess and validate. We also agree that treating
physicians can provide important information about the validity and
impact of fatigue on functioning. In fact, our regulations at
Sec. Sec. 404.1527 and 416.927 require us to consider medical source
opinions about the nature and severity of impairments, including
opinions about symptoms and their effects on functioning. However,
these same rules do not allow us to rely solely on the judgment of the
treating physician, as the commenters may have been suggesting. The
rules identify factors we must consider in determining whether to
accept a treating source's medical opinion, including an opinion about
an individual's symptoms. We must also evaluate the symptom of fatigue
under Sec. Sec. 404.1529 and 416.929 of our regulations, which provide
a variety of factors that we must consider.
Comment: One commenter suggested that hepatitis C should be
included in the hematological body system (7.00 and 107.00) since it is
a blood-borne virus.
Response: We did not adopt the comment because hepatitis is
primarily a liver disorder and should be evaluated in the digestive
disorders body system.
Comment: One commenter stated that only those individuals who
suffer from hepatitis C know the extent of their symptoms and only they
should make judgments about the appropriate disability criteria for
this disease.
Another commenter recommended that we employ doctors who deal with
a large number of patients with hepatitis. The commenter further
[[Page 59417]]
recommended that we consult with the American Association for the Study
of Liver Disease (AASLD) for a list of experts in the field. Another
commenter indicated that some doctors who do not deal regularly with an
indigent population or those that have retired from active practice may
not have expertise in assessing hepatitis B and C. The commenter
recommended that community health centers or other public entities
should be used as a source of medical expertise.
Response: As we note at the beginning of the comment and response
section of this preamble, we reopened the comment period on the NPRM so
that we could receive additional input on our rules for evaluating
chronic liver disease. In addition to the outreach meeting we conducted
in Cambridge, Massachusetts in November of 2004, at which a number of
experts presented, we also asked other people with expertise to send us
written comments. As a result of these efforts, we received many
comments from medical specialists, advocates who specialize in chronic
liver disease (including hepatitis B and C), and patients. We adopted
many of the comments from these individuals.
We generally agree with the commenters who indicated that it would
be better if we used doctors in our program who have expertise in
evaluating and treating individuals with hepatitis, or any chronic
liver diseases, and we do use such experts whenever possible. We also
asked the Institute of Medicine of the National Academies to study the
issue of medical expertise in our disability evaluations and to
recommend ways in which we can make better use of medical expertise in
our case adjudications. They issued their report, Improving the Social
Security Disability Decision Process, on February 13, 2007.\2\ We are
now considering their findings and recommendations for future
improvements.
---------------------------------------------------------------------------
\2\ Institute of Medicine of the National Academies, Committee
on Improving the Disability Decision Process. Improving the Social
Security Disability Decision Process. Washington, DC: The National
Academies Press, 2007. The report is available at http://www.nap.edu/catalog.php?record_id=11859
.
---------------------------------------------------------------------------
Comment: One commenter said that a Veterans Administration (VA)
disability rating of 100 percent due to hepatitis C should trigger
automatic payment of Social Security disability benefits, as it does
for disabled railroad employees. The commenter stated that this would
save tax dollars and eliminate inequity between the two Federal
programs.
Response: We did not adopt the comment. Under sections 205(b)(1)
and 1631(c)(1)(A) of the Act and Sec. Sec. 404.1504 and 416.904 of our
regulations, we are required to make a determination of disability
independent of other agencies, such as the VA. Also, the disability
standard the VA uses is not the same as our disability standard.
However, our regulations do provide that we must consider
determinations made by other agencies, including the VA, when we make
our determinations and decisions (see Sec. Sec. 404.1504,
404.1512(b)(5), 416.904, and 416.912(b)(5)).
The reason that a decision awarding disability benefits for the
Railroad Retirement Board sometimes applies to Social Security
disability benefits is that there is a law that permits this
presumption. Also, the determinations of disability that we accept use
the same standard that we use for determining disability under our
programs; in some cases, we make the determination of disability that
the Railroad Retirement Board uses.
Comment: One commenter suggested that hepatitis C should be a
category for SSA disability at the point of diagnosis, stating that
genotyping and treatment costs are prohibitive. This commenter stated
that there was no help for those in the interim between contracting the
disease and being near death under the current standards, and those
individuals must go without any assistance for years until they meet
the criteria in the chronic liver disease listings.
Another commenter noted that the symptoms of hepatitis C virus
infection make learning a new, less strenuous trade an unrealistic
option if an individual does not become symptomatic until later in
life.
Response: While we understand the concern of the first commenter,
we do not have the authority to do what the commenter asked. To qualify
for Social Security Disability Insurance or Supplemental Security
Income benefits, individuals must show that they are disabled under the
definition of disability in the Act.
Likewise, with regard to the second comment, we cannot pay
disability benefits under the Act to individuals who are not currently
disabled but who may become disabled in the future. However, at the
fifth step of our sequential evaluation process (described near the end
of this preamble) we do consider an individual's age, education, and
work experience. At this step, the older an individual becomes, the
more likely it is that we will find the individual unable to make an
adjustment to other work; that is, the more likely we will find that
the individual is disabled.
Comment: One commenter recommended that we include a reference to
hepatitis B under recurrent and persistent syndromes because chronic
fatigue syndrome (CFS) and depression are common symptoms and these
functional limitations are debilitating and prevalent enough that they
merit inclusion.
Response: We did not adopt this comment but we did provide guidance
on hepatitis B in final 5.00D4b and 105.00D4b. We did not include a
reference to CFS in this final rule partly because it is a diagnosis of
exclusion; that is, the diagnosis is not made if another physical or
mental impairment, such as hepatitis, is present that can account for
the symptoms. We explain our policy for evaluating CFS in Social
Security Ruling 99-2p, ``Titles II and XVI: Evaluating Cases Involving
Chronic Fatigue Syndrome (CFS),'' 83 FR 23380 (April 30, 1999).\3\
---------------------------------------------------------------------------
\3\ The ruling is also available at http://www.socialsecurity.gov/OP_Home/rulings/di/01/SSR99=02=di=01.html
.
---------------------------------------------------------------------------
Comment: Many commenters stated that individuals undergoing
interferon/ribavirin treatment for hepatitis C cannot work as the
treatment seriously interferes with physical and mental stamina. One
commenter observed that it was unfair to patients and employers to
expect those who are undergoing treatment for hepatitis C to work due
to the side effects of the treatment. They asked us to use compassion
when we make decisions regarding changes in the chronic liver disease
criteria. Another commenter stated that disability benefits would be
helpful for patients when going through treatment or transplant as the
symptoms attack on all fronts.
Response: Partly in response to these comments, we included
guidance in final 5.00D4 and 105.00D4 about the types of treatment for
hepatitis C, including interferon/ribavirin treatment for adults and
children, and the common adverse effects of treatment. However, we
cannot automatically grant disability benefits if an individual is
undergoing treatment for hepatitis B or C. Everyone reacts differently
to the treatment and we must evaluate the disease progression, side
effects of treatment, and response to treatment on an individual basis,
unless in the future we can identify a diagnostic technique that would
allow us to use a conclusive presumption that a case of hepatitis is so
severe the individual cannot, as a practical matter, engage in any
gainful activity.
Comment: Some commenters suggested that we should include
[[Page 59418]]
neuropsychological testing in the evaluation of any person seeking
Social Security disability benefits for chronic liver disease,
regardless of liver histology, because 50 percent of individuals with
chronic hepatitis C experience cognitive impairment and chronic
fatigue, even in individuals with mild liver disease.
Response: We did not adopt the comment. Neuropsychological testing
is highly specialized, and we generally try to exhaust all other or
more direct avenues before we purchase such testing. Also, the testing
examines fine areas of brain functioning and not the global functioning
that we are generally most interested in for our disability
evaluations.
Comment: Several commenters suggested that the medical criteria be
kept in line with the National Institutes of Health (NIH) Consensus
Statement on the Management of Hepatitis C (the Consensus
Statement).\4\
---------------------------------------------------------------------------
\4\ http://consensus.nih.gov/2002/2002HepatitisC2002116PDF.pdf.
---------------------------------------------------------------------------
Response: With the additional material we added as described above,
we believe that these final rules are consistent with the Consensus
Statement to the extent appropriate for our disability evaluation
criteria under the listings. There is a considerable amount of
information in the Consensus Statement that is not specifically
relevant to our disability adjudications (for example, discussion of
treatment options and recommendations for more education and research)
or that goes beyond what is appropriate to include in our listings.
Listings 5.06 and 105.06 Inflammatory Bowel Disease
Comment: We received many comments about IBD. Some commenters were
concerned that the listings focused on recurrent intestinal obstruction
or fistulae as practically the only criteria for disability due to IBD.
The commenters agreed that most individuals with IBD respond to medical
or surgical treatment and lead fairly normal lives, but they indicated
that there is a subset of individuals who have recurring and persisting
disease that is refractory to treatment and makes them unable to work.
The commenters suggested that many of these individuals would not be
covered by the proposed listings and would face difficulty with their
claims.
The commenters indicated that individuals with IBD can be
incapacitated by persistent abdominal pain that may be unassociated
with either obstruction or fistulae. They also said that profound
fatigue due to the underlying inflammatory disease or the resulting and
often complex nutritional deficiencies that accompany these disorders
may be incapacitating. The commenters mentioned several symptoms and
signs that could be refractory to medical and surgical treatment; for
example, recurrent obstruction, anemia, fistulae, abscess, or other
perineal or intra-abdominal complications. They also noted that
recurrent and persisting severe diarrhea, with or without incontinence,
makes it impossible for many individuals with IBD to sustain any
activity for even modest periods of time. One of the commenters stated
that many of the most challenging symptoms of IBD cannot be directly
quantified by the usual objective studies, including imaging or
laboratory tests, resulting in our excluding relief to many who need
and deserve it.
Another commenter stated that we did not sufficiently address
recurrent diarrhea and bowel incontinence that do not lead to weight
loss or malnutrition. This commenter noted that these conditions may
require proximity to a restroom or may interfere with the ability to
work in public. The commenter acknowledged that they are ``probably
not'' listings issues, but said that there did not appear to be
sufficient guidance for disability adjudicators on how to consider
these issues.
Two individuals who have IBD and who had filed claims for
disability benefits described how profound the disease was for them and
expressed concern about any changes we might make that would make it
more difficult to qualify. One of these commenters, who has Crohn's
disease, described the embarrassment of the disease and the other kinds
of illnesses she has had that are associated with the disease and its
treatment. The other commenter said that he was against any change in
our present regulations that would make it more difficult for a person
with IBD to qualify for disability benefits. He said that the proposed
changes would cause an added hardship for individuals with IBD.
Response: We adopted most of the comments and completely revised
proposed listings 5.06 and 105.06 and the introductory text for IBD. In
response to these comments, we added final 5.00E in the introductory
text in part A and revised and expanded proposed 105.00F4 (final
105.00E) in part B to provide more detailed guidance for documenting
and evaluating IBD in adults and children. We also added criteria in
final listings 5.06 and 105.06 to include some of the other
manifestations of IBD mentioned by the commenters.
The new sections in the introductory text include most of the
examples of symptoms and signs of IBD that the commenters mentioned, as
well as others that the commenters did not specifically mention,
including a longer list of potential manifestations in other body
systems than we included under the prior listings. In addition, we
revised proposed listings 5.06 and 105.06 by adding a list of six
manifestations in paragraph B of final listing 5.06 and a list of five
manifestations in paragraph B of final listing 105.06.
We did not include criteria for manifestations like severe diarrhea
or fecal incontinence. We believe that the effect of severe diarrhea is
best identified at the listing level by the criteria in 5.06B1 and
105.06B1 (anemia with a hemoglobin of less than 10 g/dL) and 5.06B2 and
105.06B2 (serum albumin of 3.0g/dL or less). We agree that there are
other consequences of severe diarrhea or fecal incontinence, such as
the necessity to be near a restroom or the difficulty of sustaining
activities for even modest amounts of time, that may significantly
affect an individual's ability to work or a child's ability to function
in an age-appropriate manner. However, we believe these consequences of
IBD are more appropriately addressed on an individual case basis when
we assess residual functional capacity or functional equivalence.
In considering these comments, we also noted that there were
unintentional differences between proposed listings 5.06B and 105.06B,
and that we included proposed 105.00F4 (final 105.00E) specifically for
children but no corresponding guidance in proposed part A for adults.
In making the revisions in the final rules, we determined that, with
minor exceptions, there was no need for the information in part A to be
different from the information in part B. Therefore, we added final
5.00E to correspond to final 105.00E, and we made a number of editorial
changes to 105.00E for consistency between the two sections. Final
5.00E and 105.00E and final listings 5.06 and 105.06 are the same,
except for the minor differences necessary to address childhood
disability that we have already noted in the explanations of the final
rules at the beginning of this preamble.
With regard to the last comments expressing concern that our
changes may make it more difficult for individuals with IBD to qualify
for disability benefits, we believe that the
[[Page 59419]]
changes we are making in these final rules are an improvement over the
proposed rules that address many of the commenters' concerns. Also, the
final rules are consistent with advances in medical science and
technology, our adjudicative experience, and our goal of appropriately
finding all individuals who are unable to perform any gainful activity
disabled under the listings.
Comment: One commenter stated that he was ``perplexed'' by the
statement in the preamble to the NPRM that ``anemia, when caused by
inflammatory bowel disease, is not an appropriate indicator of listing-
level severity.'' (See 66 FR at 57013.) The commenter noted that we
have long held that chronic anemia with persistent hematocrit below 30
percent is of listing-level severity. The commenter asserted that
people with chronic anemia are tired, fatigued, and have poor stamina,
and that there are other factors that affect their ability to function.
Another commenter stated that our proposed reasons for changes to
the listing were inaccurate. The commenter questioned our statement
that ``a gradual reduction in hemoglobin, even to very low levels, is
often well tolerated and does not correlate with ability to function.''
(See 66 FR at 57013.) The commenter stated that studies show that
quality of life and functional status correlate with hemoglobin levels.
Response: It is true that we have long had listings that are met
with anemia demonstrated by hematocrits of 30 percent or less. We also
agree that anemia may cause the kinds of symptoms listed. However,
listing criteria must represent a level of severity that prevents ``any
gainful activity.'' We cannot presume, based only on low hematocrit (or
hemoglobin) levels, that the symptoms referred to will be present or
sufficiently severe in all cases to determine that an individual is
disabled. The body adapts to a gradual lowering of hematocrit (or
hemoglobin) levels, therefore there is not a strong correlation between
hematocrit levels and the ability to function. We removed a similar
criterion from the genitourinary system listings for the same reason.
See 70 FR 38582, 38586 (2005).
However, we have included a criterion for anemia with hemoglobin of
less than 10 g/dL as one of the criteria of final listings 5.06B and
105.06B. We believe that it is an appropriate criterion when it occurs
in conjunction with at least one of the other manifestations of IBD
listed in the final rules. We are using hemoglobin (measured in units
of g/dL) rather than hematocrit (percent) in assessing the degree of
anemia as the former laboratory measurement is more accurate.
Listing 5.08 Weight Loss Due to Any Digestive Disorder
Comment: A commenter suggested that we include guidance that height
be measured without shoes in the introductory text to the listings.
Another commenter noted that, although we explained in the NPRM how to
round inches and centimeters, we did not explain how to round pounds
and kilograms.
Response: We adopted the first comment. Because the final listings
are based on BMI, we now explain in final 5.00G2a that measurements of
both weight and height must be made without shoes.
We did not need to adopt the second comment because we changed the
weight loss criteria to BMI measurements and as a consequence removed
the proposed rule for rounding. Because of this change, we also did not
include the height and weight tables from proposed listing 5.08.
Comment: Two commenters believed that the height and weight tables
in the regulations did not reflect the chronicity and severity of
disease in individuals with IBD who are routinely treated with
corticosteroids. The commenters indicated that corticosteroids lead to
substantial salt and water retention and increased fatty tissue
accumulation, so that nutritionally depleted patients may have
artificially sustained weight. They also noted that it is not uncommon
for patients with crippling symptoms, hypoalbuminemia, and nutritional
deficiencies to have ``normal'' or increased weight due to the
corticosteroids.
Response: We agree with the commenters that individuals with IBD
may have ``normal'' weight; however, final listing 5.08 is specifically
for individuals with weight loss as a consequence of a digestive
disorder. Individuals whose impairments do not meet listing 5.08 may
still meet the criteria of another listing. As we explained earlier, we
have significantly expanded final listings 5.06 and 105.06 to include
criteria for many of the symptoms and signs of IBD. For example, we
have included criteria in final 5.06B1 and B8 under which individuals
with IBD who are nutritionally depleted but have sustained weight may
qualify. Also in response to these comments, we have provided examples
in final 5.00E2 and 105.00E2 of signs and laboratory findings that may
demonstrate malnutrition in the absence of weight loss, such as edema,
anemia, hypoalbuminemia, hypokalemia, hypocalcemia, and hypomagnesemia.
If the impairment does not meet or medically equal a listing, we will
continue our evaluation through the sequential evaluation process.
Listing 105.08 Malnutrition
Comment: Two commenters suggested that we move the guidelines for
what is needed to document malnutrition from proposed 105.00F of the
introductory text into listing 105.08 because they were so specific.
Response: We adopted the comments and included three of the
proposed examples as criteria in final listing 105.08A. We did not
include the example of steatorrhea for reasons we have already
explained. Also, as explained earlier, we changed the criteria in final
105.08A1 for anemia to a hemoglobin of less than 10.0 g/dL.
Comment: One commenter suggested that we specify that we use the
most current edition when we refer to the CDC chart in listing 105.08
and in the introductory text. This would ensure that the listing
criteria continue to reflect the latest guidance.
Response: We adopted the comment. The change appears in final
105.00G2 and in final listings 105.08B1 and B2.
Listings 5.09 and 105.09
Comment: One commenter suggested that as long as an individual is
required to take anti-rejection drugs after a transplanted organ, at
the very least, medical benefits should continue.
Response: We did not adopt this comment because we do not have the
authority to do what the commenter asked. We can only pay benefits to
individuals who are under a disability as defined in the Act and our
regulations, and Medicare and Medicaid benefits generally depend on
continuing entitlement to disability benefits.
Comment: One commenter stated that disability benefits should last
for 18 months after a liver transplant because transplants do not
remedy the underlying cause of the disease, such as viral hepatitis.
Response: We did not adopt this comment because in our experience
12 months is a sufficient period after which we need to reevaluate each
individual's status to see if he or she is still disabled. This is the
period we provide for most other transplants. See, for example,
listings 3.11 (lung), 4.09 (heart), 6.02 (kidney), 7.17 (aplastic
anemia with bone marrow or stem cell transplantation), and 13.05
(lymphoma with bone marrow or stem cell transplantation). Also, we
published the
[[Page 59420]]
liver transplant listing in 2002 in another notice; these final rules
do not make any substantive changes to that rule, only editorial
revisions. And as we have already noted, the 1-year rule does not mean
that an individual's disability automatically ends 1 year after the
transplant. Our rule is only that after 1 year we generally will
consider whether the individual is still disabled. Our existing rules
also allow our adjudicators to set a later diary date for review of
continuing disability if the facts of the case warrant it.
Other Comments
Comment: One commenter did not support our proposal to remove
reference listings. The commenter believed that it is easier for our
adjudicators to recognize the need to document and evaluate an
impairment if it is also included in the listing itself. The commenter
also noted that reference listings assure the public and their
physicians that a specific impairment has been considered.
Response: We did not adopt the comment. With one exception, all of
the reference listings in the part A digestive disorder listings were
to listing 5.08, the listing for weight loss. We believe that our
adjudicators, the public, and their physicians will easily see that
final listing 5.08 is applicable to weight loss due to any digestive
disorder. The only exception in part A was for hepatic encephalopathy,
which cross-referred to listing 12.02; however, we have now added a
listing specifically for hepatic encephalopathy (final listing 5.05F)
in the digestive disorders listings. Part B was essentially the same,
with most reference listings cross-referring to listing 105.08, and a
reference listing for hepatic encephalopathy, which we now list in
final listing 105.05F. Prior listing 105.07C also referred to growth
impairment listing 100.03. We are removing that reference listing
without replacement; however, as we have already noted, we have added
references to growth impairment in the introductory text to these
listings and we believe that this is sufficient.
We do not agree that the prior reference listings were especially
helpful to adjudicators. All individuals who would qualify under any of
the provisions of our prior reference listings will continue to qualify
under other listings or the rules for medical or functional equivalence
for children. Also, because reference listings are redundant, we are
removing them from all the body systems as we revise them; therefore,
we would be inconsistent if we retained reference listings only in this
body system. Our adjudicators are aware that the listings do not
include all possible disabling impairments, so they review all of the
evidence, including the claimant's allegations and the medical evidence
from treating and other medical sources, to identify the impairments
they must evaluate.
Comment: One commenter suggested that we include some discussion in
the introductory text of how to evaluate digestive impairments for
which there is no specific listing, such as peptic ulcer disease and
chronic pancreatitis.
Response: We did not add specific information in the introductory
text about peptic ulcer disease or chronic pancreatitis because we
prefer to include information that is relevant to the application of
these listings. However, we do make it clear that we may evaluate
digestive disorders that are not specifically named in the introductory
text under this body system.
Comment: One commenter asked that we consider the unique health
risks and cultural issues that affect Asian Americans and immigrant
communities.
Response: We did not adopt the comment. We are not aware of any
current medical distinction that supports the suggestion.
Additional Information
What programs do these final rules affect?
These final rules affect disability determinations and decisions
that we make under title II and title XVI of the Act. In addition, to
the extent that Medicare entitlement and Medicaid eligibility are based
on whether you qualify for disability benefits under title II or title
XVI, these final rules also affect the Medicare and Medicaid programs.
Who can get disability benefits?
Under title II of the Act, we provide for the payment of disability
benefits if you are disabled and belong to one of the following three
groups:
Workers insured under the Act;
Children of insured workers; and
Widows, widowers, and surviving divorced spouses (see
Sec. 404.336) of insured individuals.
Under title XVI of the Act, we provide for Supplemental Security
Income (SSI) payments on the basis of disability if you are disabled
and have limited income and resources.
How do we define disability?
Under both the title II and title XVI programs, disability must be
the result of any medically determinable physical or mental impairment
or combination of impairments that is expected to result in death or
that has lasted or can be expected to last for a continuous period of
at least 12 months. Our definitions of disability are shown in the
following table:
------------------------------------------------------------------------
Disability means you
have a medically
If you file a claim under . . And you are . . . determinable
. impairment(s) as
described above that
results in . . .
------------------------------------------------------------------------
title II...................... an adult or a the inability to do
child. any substantial
gainful activity
(SGA).
title XVI..................... an individual age the inability to do
18 or older. any SGA.
title XVI..................... an individual marked and severe
under age 18. functional
limitations.
------------------------------------------------------------------------
How do we decide whether you are disabled?
To decide whether you are disabled under the Act, we use a five-
step ``sequential evaluation process,'' which we describe in our
regulations at Sec. Sec. 404.1520 and 416.920. We follow the five
steps in order and stop as soon as we can make a determination or
decision. The steps are:
1. Are you working, and is the work you are doing substantial
gainful activity? If you are working and the work you are doing is
substantial gainful activity, we will find that you are not disabled,
regardless of your medical condition or your age, education, and work
experience. If you are not, we will go on to step 2.
2. Do you have a ``severe'' impairment? If you do not have an
impairment or combination of impairments that significantly limits your
physical or mental ability to do basic work activities, we will find
that you are not disabled. If you do, we will go on to step 3.
3. Do you have an impairment(s) that meets or medically equals the
severity of an impairment in the listings? If you do, and the
impairment(s) meets the duration requirement, we will find that
[[Page 59421]]
you are disabled. If you do not, we will go on to step 4.
4. Do you have the residual functional capacity to do your past
relevant work? If you do, we will find that you are not disabled. If
you do not, we will go on to step 5.
5. Does your impairment(s) prevent you from doing any other work
that exists in significant numbers in the national economy, considering
your residual functional capacity, age, education, and work experience?
If it does, and it meets the duration requirement, we will find that
you are disabled. If it does not, we will find that you are not
disabled.
We use a different sequential evaluation process for children who
apply for payments based on disability under SSI. If you are already
receiving benefits, we also use a different sequential evaluation
process when we decide whether your disability continues. See
Sec. Sec. 404.1594, 416.924, 416.994, and 416.994a of our regulations.
However, all of these processes also include steps at which we consider
whether your impairment meets or medically equals one of our listings.
What are the listings?
The listings are examples of impairments that we consider severe
enough to prevent you as an adult from doing any gainful activity. If
you are a child seeking SSI payments based on disability, the listings
describe impairments that we consider severe enough to result in marked
and severe functional limitations. Although the listings are contained
only in appendix 1 to subpart P of part 404 of our regulations, we
incorporate them by reference in the SSI program in Sec. 416.925 of
our regulations, and apply them to claims under both title II and title
XVI of the Act.
How do we use the listings?
The listings are in two parts. There are listings for adults (part
A) and for children (part B). If you are an individual age 18 or over,
we apply the listings in part A when we assess your claim, and we never
use the listings in part B.
If you are an individual under age 18, we first use the criteria in
part B of the listings. Part B contains criteria that apply only to
individuals who are under age 18. If your impairment does not meet the
criteria in part B, we may then use the criteria in part A when those
criteria give appropriate consideration to the effects of the
impairment(s) in children. (See Sec. Sec. 404.1525 and 416.925.)
If your impairment(s) does not meet any listing, we will also
consider whether it medically equals any listing; that is, whether it
is as medically severe as an impairment in the listings. (See
Sec. Sec. 404.1526 and 416.926.)
What if you do not have an impairment(s) that meets or medically equals
a listing?
We use the listings only to decide that you are disabled or that
you are still disabled. We will not deny your claim or decide that you
no longer qualify for benefits because your impairment(s) does not meet
or medically equal a listing. If you are not working and you have a
severe impairment(s) that does not meet or medically equal any listing,
we may still find you disabled based on other rules in the sequential
evaluation process that we use to evaluate all disability claims.
Likewise, we will not decide that your disability has ended only
because your impairment(s) does not meet or medically equal a listing.
Also, when we conduct reviews to determine whether your disability
continues, we will not find that your disability has ended because we
have changed a listing. Our regulations explain that, when we change
our listings, we continue to use our prior listings when we review your
case, if you qualified for disability benefits or SSI payments based on
our determination or decision that your impairment(s) met or medically
equaled a listing. In these cases, we determine whether you have
experienced medical improvement, and if so, whether the medical
improvement is related to the ability to work. If your condition(s) has
medically improved so that you no longer meet or medically equal the
prior listing, we evaluate your case further to determine whether you
are currently disabled. We may find that you are currently disabled,
depending on the full circumstances of your case. See Sec. Sec.
404.1594(c)(3)(i) and 416.994(b)(2)(iv)(A). If you are a child who is
eligible for SSI payments, we follow a similar rule after we decide
that you have experienced medical improvement in your condition(s). See
Sec. 416.994a(b)(2).
What is our authority to make rules and set procedures for determining
whether a person is disabled under the statutory definition?
Section 205(a) of the Act and, by reference to section 205(a),
section 1631(d)(1) provide that:
The Commissioner of Social Security shall have full power and
authority to make rules and regulations and to establish procedures,
not inconsistent with the provisions of this title, which are
necessary or appropriate to carry out such provisions, and shall
adopt reasonable and proper rules and regulations to regulate and
provide for the nature and extent of the proofs and evidence and the
method of taking and furnishing the same in order to establish the
right to benefits hereunder.
Regulatory Procedures
Executive Order 12866
We have consulted with the Office of Management and Budget (OMB)
and determined that these final rules meet the criteria for a
significant regulatory action under Executive Order 12866, as amended.
Thus, they were subject to OMB review.
Our proposed rules met the criteria for an economically significant
regulatory action under Executive Order 12866. They were also ``major''
rules under 5 U.S.C. 801ff. For the reasons stated earlier in this
preamble, these final rules reflect changes we have made from the
proposed rules. Based on these changes, we estimate that these final
rules will result in program savings but will not constitute an
economically significant regulatory action or ``major'' rules.
We are projecting savings in program expenditures as described
below.
Program Savings
1. Title II
We estimate that these final rules would result in reduced program
outlays resulting in the following savings (in millions of dollars) to
the title II program ($132 million total in a 5-year period beginning
in FY 2008).
----------------------------------------------------------------------------------------------------------------
FY 2008 FY 2009 FY 2010 FY 2011 FY 2012 Total
----------------------------------------------------------------------------------------------------------------
-$10 -$19 -$27 -$35 -$42 -$132 \5\
----------------------------------------------------------------------------------------------------------------
\5\ 5-year total may not be equal to the sum of the annual totals due to rounding.
[[Page 59422]]
2. Title XVI
We estimate that these final rules will result in reduced program
outlays resulting in the following savings (in millions of dollars) to
the SSI program ($25 million in a 5-year period beginning in FY 2008).
----------------------------------------------------------------------------------------------------------------
FY 2008 FY 2009 FY 2010 FY 2011 FY 2012 Total
----------------------------------------------------------------------------------------------------------------
-$1 -$3 -$5 -$8 -$8 -$25 \6\
----------------------------------------------------------------------------------------------------------------
\6\ Federal SSI payments due on October 1st in fiscal year 2012 are included with payments for the prior fiscal
year.
Regulatory Flexibility Act
We certify that these final rules will not have a significant
economic impact on a substantial number of small entities because they
affect only individuals. Thus, a regulatory flexibility analysis as
provided in the Regulatory Flexibility Act, as amended, is not
required.
Paperwork Reduction Act
The Paperwork Reduction Act (PRA) of 1995 says that no persons are
required to respond to a collection of information unless it displays a
valid OMB control number. In accordance with the PRA, SSA is providing
notice that OMB has approved the information collection requirements
contained in Part A, 5.00 and Part B, 105.00 of these final rules. The
OMB Control Number for this collection is 0960-0642 expiring March 31,
2008.
(Catalog of Federal Domestic Program Nos. 96.001, Social Security--
Disability Insurance; 96.002, Social Security--Retirement Insurance;
96.004, Social Security--Survivors Insurance; and 96.006,
Supplemental Security Income)
List of Subjects
20 CFR Part 404
Administrative practice and procedure, Death benefits, Blind,
Disability benefits, Old-age, survivors, and disability insurance,
Reporting and recordkeeping requirements, Social Security.
20 CFR Part 416
Administrative practice and procedure, Aged, Blind, Disability
benefits, Public assistance programs, Reporting and recordkeeping
requirements, Supplemental Security Income (SSI).
Dated: June 25, 2007.
Michael J. Astrue,
Commissioner of Social Security.
0
For the reasons set forth in the preamble, subpart P of part 404 and
subpart I of part 416 of chapter III of title 20 of the Code of Federal
Regulations are amended as set forth below:
PART 404--FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE
(1950-)
0
1. The authority citation for subpart P of part 404 continues to read
as follows:
Authority: Secs. 202, 205(a), (b), and (d)-(h), 216(i), 221(a)
and (i), 222(c), 223, 225, and 702(a)(5) of the Social Security Act
(42 U.S.C. 402, 405(a), (b), and (d)-(h), 416(i), 421(a) and (i),
422(c), 423, 425, and 902(a)(5)); sec. 211(b), Pub. L. 104-193, 110
Stat. 2105, 2189; sec. 202, Pub. L. 108-203, 118 Stat. 509 (42
U.S.C. 902 note).
Appendix 1 to Subpart P of Part 404--Listing of Impairments [Amended]
0
2. Revise item 6 of the introductory text before part A of appendix 1
to subpart P of part 404 to read as follows:
Appendix 1 to Subpart P of Part 404--Listing of Impairments
* * * * *
6. Digestive System (5.00 and 105.00): October 19, 2012.
* * * * *
0
3. Revise section 5.00 in part A of appendix 1 to subpart P of part 404
to read as follows:
Appendix 1 to Subpart P of Part 404--Listing of Impairments
* * * * *
Part A
* * * * *
5.00 DIGESTIVE SYSTEM
A. What kinds of disorders do we consider in the digestive
system? Disorders of the digestive system include gastrointestinal
hemorrhage, hepatic (liver) dysfunction, inflammatory bowel disease,
short bowel syndrome, and malnutrition. They may also lead to
complications, such as obstruction, or be accompanied by
manifestations in other body systems.
B. What documentation do we need? We need a record of your
medical evidence, including clinical and laboratory findings. The
documentation should include appropriate medically acceptable
imaging studies and reports of endoscopy, operations, and pathology,
as appropriate to each listing, to document the severity and
duration of your digestive disorder. Medically acceptable imaging
includes, but is not limited to, x-ray imaging, sonography,
computerized axial tomography (CAT scan), magnetic resonance imaging
(MRI), and radionuclide scans. Appropriate means that the technique
used is the proper one to support the evaluation and diagnosis of
the disorder. The findings required by these listings must occur
within the period we are considering in connection with your
application or continuing disability review.
C. How do we consider the effects of treatment?
1. Digestive disorders frequently respond to medical or surgical
treatment; therefore, we generally consider the severity and
duration of these disorders within the context of prescribed
treatment.
2. We assess the effects of treatment, including medication,
therapy, surgery, or any other form of treatment you receive, by
determining if there are improvements in the symptoms, signs, and
laboratory findings of your digestive disorder. We also assess any
side effects of your treatment that may further limit your
functioning.
3. To assess the effects of your treatment, we may need
information about:
a. The treatment you have been prescribed (for example, the type
of medication or therapy, or your use of parenteral (intravenous)
nutrition or supplemental enteral nutrition via a gastrostomy);
b. The dosage, method, and frequency of administration;
c. Your response to the treatment;
d. Any adverse effects of such treatment; and
e. The expected duration of the treatment.
4. Because the effects of treatment may be temporary or long-
term, in most cases we need information about the impact of your
treatment, including its expected duration and side effects, over a
sufficient period of time to help us assess its outcome. When
adverse effects of treatment contribute to the severity of your
impairment(s), we will consider the duration or expected duration of
the treatment when we assess the duration of your impairment(s).
5. If you need parenteral (intravenous) nutrition or
supplemental enteral nutrition via a gastrostomy to avoid
debilitating complications of a digestive disorder, this treatment
will not, in itself, indicate that you are unable to do any gainful
activity, except under 5.07, short bowel syndrome (see 5.00F).
6. If you have not received ongoing treatment or have not had an
ongoing relationship with the medical community despite the
existence of a severe impairment(s), we will evaluate the severity
and duration of your digestive impairment on the basis of the
current medical and other evidence in your case record. If you have
not received treatment, you may not be able to show an impairment
that meets the criteria of one of the digestive system listings, but
your digestive impairment may medically
[[Page 59423]]
equal a listing or be disabling based on consideration of your
residual functional capacity, age, education, and work experience.
D. How do we evaluate chronic liver disease?
1. General. Chronic liver disease is characterized by liver cell
necrosis, inflammation, or scarring (fibrosis or cirrhosis), due to
any cause, that persists for more than 6 months. Chronic liver
disease may result in portal hypertension, cholestasis (suppression
of bile flow), extrahepatic manifestations, or liver cancer. (We
evaluate liver cancer under 13.19.) Significant loss of liver
function may be manifested by hemorrhage from varices or portal
hypertensive gastropathy, ascites (accumulation of fluid in the
abdominal cavity), hydrothorax (ascitic fluid in the chest cavity),
or encephalopathy. There can also be progressive deterioration of
laboratory findings that are indicative of liver dysfunction. Liver
transplantation is the only definitive cure for end stage liver
disease (ESLD).
2. Examples of chronic liver disease include, but are not
limited to, chronic hepatitis, alcoholic liver disease, non-
alcoholic steatohepatitis (NASH), primary biliary cirrhosis (PBC),
primary sclerosing cholangitis (PSC), autoimmune hepatitis,
hemochromatosis, drug-induced liver disease, Wilson's disease, and
serum alpha-1 antitrypsin deficiency. Acute hepatic injury is
frequently reversible, as in viral, drug-induced, toxin-induced,
alcoholic, and ischemic hepatitis. In the absence of evidence of a
chronic impairment, episodes of acute liver disease do not meet
5.05.
3. Manifestations of chronic liver disease.
a. Symptoms may include, but are not limited to, pruritis
(itching), fatigue, nausea, loss of appetite, or sleep disturbances.
Symptoms of chronic liver disease may have a poor correlation with
the severity of liver disease and functional ability.
b. Signs may include, but are not limited to, jaundice,
enlargement of the liver and spleen, ascites, peripheral edema, and
altered mental status.
c. Laboratory findings may include, but are not limited to,
increased liver enzymes, increased serum total bilirubin, increased
ammonia levels, decreased serum albumin, and abnormal coagulation
studies, such as increased International Normalized Ratio (INR) or
decreased platelet counts. Abnormally low serum albumin or elevated
INR levels indicate loss of synthetic liver function, with increased
likelihood of cirrhosis and associated complications. However, other
abnormal lab tests, such as liver enzymes, serum total bilirubin, or
ammonia levels, may have a poor correlation with the severity of
liver disease and functional ability. A liver biopsy may demonstrate
the degree of liver cell necrosis, inflammation, fibrosis, and
cirrhosis. If you have had a liver biopsy, we will make every
reasonable effort to obtain the results; however, we will not
purchase a liver biopsy. Imaging studies (CAT scan, ultrasound, MRI)
may show the size and consistency (fatty liver, scarring) of the
liver and document ascites (see 5.00D6).
4. Chronic viral hepatitis infections.
a. General.
(i) Chronic viral hepatitis infections are commonly caused by
hepatitis C virus (HCV), and to a lesser extent, hepatitis B virus
(HBV). Usually, these are slowly progressive disorders that persist
over many years during which the symptoms and signs are typically
nonspecific, intermittent, and mild (for example, fatigue,
difficulty with concentration, or right upper quadrant pain).
Laboratory findings (liver enzymes, imaging studies, liver biopsy
pathology) and complications are generally similar in HCV and HBV.
The spectrum of these chronic viral hepatitis infections ranges
widely and includes an asymptomatic state; insidious disease with
mild to moderate symptoms associated with fluctuating liver tests;
extrahepatic manifestations; cirrhosis, both compensated and
decompensated; ESLD with the need for liver transplantation; and
liver cancer. Treatment for chronic viral hepatitis infections
varies considerably based on medication tolerance, treatment
response, adverse effects of treatment, and duration of the
treatment. Comorbid disorders, such as HIV infection, may affect the
clinical course of viral hepatitis infection(s) or may alter the
response to medical treatment.
(ii) We evaluate all types of chronic viral hepatitis infections
under 5.05 or any listing in an affected body system(s). If your
impairment(s) does not meet or medically equal a listing, we will
consider the effects of your hepatitis when we assess your residual
functional capacity.
b. Chronic hepatitis B virus (HBV) infection.
(i) Chronic HBV infection is diagnosed by the detection of
hepatitis B surface antigen (HBsAg) in the blood for at least 6
months. In addition, detection of the hepatitis B envelope antigen
(HBeAg) suggests an increased likelihood of progression to cirrhosis
and ESLD.
(ii) The therapeutic goal of treatment is to suppress HBV
replication and thereby prevent progression to cirrhosis and ESLD.
Treatment usually includes a combination of interferon injections
and oral antiviral agents. Common adverse effects of treatment are
the same as noted in 5.00D4c(ii) for HCV, and generally end within a
few days after treatment is discontinued.
c. Chronic hepatitis C virus (HCV) infection.
(i) Chronic HCV infection is diagnosed by the detection of
hepatitis C viral RNA in the blood for at least 6 months.
Documentation of the therapeutic response to treatment is also
monitored by the quantitative assay of serum HCV RNA (``HCV viral
load''). Treatment usually includes a combination of interferon
injections and oral ribavirin; whether a therapeutic response has
occurred is usually assessed after 12 weeks of treatment by checking
the HCV viral load. If there has been a substantial reduction in HCV
viral load (also known as early viral response, or EVR), this
reduction is predictive of a sustained viral response with
completion of treatment. Combined therapy is commonly discontinued
after 12 weeks when there is no early viral response, since in that
circumstance there is little chance of obtaining a sustained viral
response (SVR). Otherwise, treatment is usually continued for a
total of 48 weeks.
(ii) Combined interferon and ribavirin treatment may have
significant adverse effects that may require dosing reduction,
planned interruption of treatment, or discontinuation of treatment.
Adverse effects may include: Anemia (ribavirin-induced hemolysis),
neutropenia, thrombocytopenia, fever, cough, fatigue, myalgia,
arthralgia, nausea, loss of appetite, pruritis, and insomnia.
Behavioral side effects may also occur. Influenza-like symptoms are
generally worse in the first 4 to 6 hours after each interferon
injection and during the first weeks of treatment. Adverse effects
generally end within a few days after treatment is discontinued.
d. Extrahepatic manifestations of HBV and HCV. In addition to
their hepatic manifestations, both HBV and HCV may have significant
extrahepatic manifestations in a variety of body systems. These
include, but are not limited to: Keratoconjunctivitis (sicca
syndrome), glomerulonephritis, skin disorders (for example, lichen
planus, porphyria cutanea tarda), neuropathy, and immune dysfunction
(for example, cryoglobulinemia, Sj[ouml]gren's syndrome, and
vasculitis). The extrahepatic manifestations of HBV and HCV may not
correlate with the severity of your hepatic impairment. If your
impairment(s) does not meet or medically equal a listing in an
affected body system(s), we will consider the effects of your
extrahepatic manifestations when we assess your residual functional
capacity.
5. Gastrointestinal hemorrhage (5.02 and 5.05A).
Gastrointestinal hemorrhaging can result in hematemesis (vomiting of
blood), melena (tarry stools), or hematochezia (bloody stools).
Under 5.02, the required transfusions of at least 2 units of blood
must be at least 30 days apart and occur at least three times during
a consecutive 6-month period. Under 5.05A, hemodynamic instability
is diagnosed with signs such as pallor (pale skin), diaphoresis
(profuse perspiration), rapid pulse, low blood pressure, postural
hypotension (pronounced fall in blood pressure when arising to an
upright position from lying down) or syncope (fainting).
Hemorrhaging that results in hemodynamic instability is potentially
life-threatening and therefore requires hospitalization for
transfusion and supportive care. Under 5.05A, we require only one
hospitalization for transfusion of at least 2 units of blood.
6. Ascites or hydrothorax (5.05B) indicates significant loss of
liver function due to chronic liver disease. We evaluate ascites or
hydrothorax that is not attributable to other causes under 5.05B.
The required findings must be present on at least two evaluations at
least 60 days apart within a consecutive 6-month period and despite
continuing treatment as prescribed.
7. Spontaneous bacterial peritonitis (5.05C) is an infectious
complication of chronic liver disease. It is diagnosed by ascitic
peritoneal fluid that is documented to contain an absolute
neutrophil count of at least 250 cells/mm3. The required
finding in 5.05C is satisfied with one evaluation documenting
[[Page 59424]]
peritoneal fluid infection. We do not evaluate other causes of
peritonitis that are unrelated to chronic liver disease, such as
tuberculosis, malignancy, and perforated bowel, under this listing.
We evaluate these other causes of peritonitis under the appropriate
body system listings.
8. Hepatorenal syndrome (5.05D) is defined as functional renal
failure associated with chronic liver disease in the absence of
underlying kidney pathology. Hepatorenal syndrome is documented by
elevation of serum creatinine, marked sodium retention, and oliguria
(reduced urine output). The requirements of 5.05D are satisfied with
documentation of any one of the three laboratory findings on one
evaluation. We do not evaluate known causes of renal dysfunction,
such as glomerulonephritis, tubular necrosis, drug-induced renal
disease, and renal infections, under this listing. We evaluate these
other renal impairments under 6.00ff.
9. Hepatopulmonary syndrome (5.05E) is defined as arterial
deoxygenation (hypoxemia) that is associated with chronic liver
disease due to intrapulmonary arteriovenous shunting and
vasodilatation in the absence of other causes of arterial
deoxygenation. Clinical manifestations usually include dyspnea,
orthodeoxia (increasing hypoxemia with erect position), platypnea
(improvement of dyspnea with flat position), cyanosis, and clubbing.
The requirements of 5.05E are satisfied with documentation of any
one of the findings on one evaluation. In 5.05E1, we require
documentation of the altitude of the testing facility because
altitude affects the measurement of arterial oxygenation. We will
not purchase the specialized studies described in 5.05E2; however,
if you have had these studies at a time relevant to your claim, we
will make every reasonable effort to obtain the reports for the
purpose of establishing whether your impairment meets 5.05E2.
10. Hepatic encephalopathy (5.05F).
a. General. Hepatic encephalopathy usually indicates severe loss
of hepatocellular function. We define hepatic encephalopathy under
5.05F as a recurrent or chronic neuropsychiatric disorder,
characterized by abnormal behavior, cognitive dysfunction, altered
state of consciousness, and ultimately coma and death. The diagnosis
is established by changes in mental status associated with fleeting
neurological signs, including ``flapping tremor'' (asterixis),
characteristic electroencephalographic (EEG) abnormalities, or
abnormal laboratory values that indicate loss of synthetic liver
function. We will not purchase the EEG testing described in 5.05F3b;
however, if you have had this test at a time relevant to your claim,
we will make every reasonable effort to obtain the report for the
purpose of establishing whether your impairment meets 5.05F.
b. Acute encephalopathy. We will not evaluate your acute
encephalopathy under 5.05F if it results from conditions other than
chronic liver disease, such as vascular events and neoplastic
diseases. We will evaluate these other causes of acute
encephalopathy under the appropriate body system listings.
11. End stage liver disease (ESLD) documented by scores from the
SSA Chronic Liver Disease (SSA CLD) calculation (5.05G).
a. We will use the SSA CLD score to evaluate your ESLD under
5.05G. We explain how we calculate the SSA CLD score in b. through
g. of this section.
b. To calculate the SSA CLD score, we use a formula that
includes three laboratory values: Serum total bilirubin (mg/dL),
serum creatinine (mg/dL), and International Normalized Ratio (INR).
The formula for the SSA CLD score calculation is:
9.57 x [Loge(serum creatinine mg/dL)]
+3.78 x [Loge(serum total bilirubin mg/dL)]
+11.2 x [Loge(INR)]
+6.43
c. When we indicate ``Loge'' in the formula for the SSA CLD
score calculation, we mean the ``base e logarithm'' or ``natural
logarithm'' (ln) of a numerical laboratory value, not the ``base 10
logarithm'' or ``common logarithm'' (log) of the laboratory value,
and not the actual laboratory value. For example, if an individual
has laboratory values of serum creatinine 1.2 mg/dL, serum total
bilirubin 2.2 mg/dL, and INR 1.0, we would compute the SSA CLD score
as follows:
9.57 x [Loge(serum creatinine 1.2 mg/dL) = 0.182]
+3.78 x [Loge(serum total bilirubin 2.2 mg/dL) = 0.788]
+11.2 x [Loge(INR 1.0) = 0]
+6.43
------
= 1.74 + 2.98 + 0 + 6.43
= 11.15, which is then rounded to an SSA CLD score of 11.
d. For any SSA CLD score calculation, all of the required
laboratory values must have been obtained within 30 days of each
other. If there are multiple laboratory values within the 30-day
interval for any given laboratory test (serum total bilirubin, serum
creatinine, or INR), we will use the highest value for the SSA CLD
score calculation. We will round all laboratory values less than 1.0
up to 1.0.
e. Listing 5.05G requires two SSA CLD scores. The laboratory
values for the second SSA CLD score calculation must have been
obtained at least 60 days after the latest laboratory value for the
first SSA CLD score and within the required 6-month period. We will
consider the date of each SSA CLD score to be the date of the first
laboratory value used for its calculation.
f. If you are in renal failure or on dialysis within a week of
any serum creatinine test in the period used for the SSA CLD
calculation, we will use a serum creatinine of 4, which is the
maximum serum creatinine level allowed in the calculation, to
calculate your SSA CLD score.
g. If you have the two SSA CLD scores required by 5.05G, we will
find that your impairment meets the criteria of the listing from at
least the date of the first SSA CLD score.
12. Liver transplantation (5.09) may be performed for metabolic
liver disease, progressive liver failure, life-threatening
complications of liver disease, hepatic malignancy, and acute
fulminant hepatitis (viral, drug-induced, or toxin-induced). We will
consider you to be disabled for 1 year from the date of the
transplantation. Thereafter, we will evaluate your residual
impairment(s) by considering the adequacy of post-transplant liver
function, the requirement for post-transplant antiviral therapy, the
frequency and severity of rejection episodes, comorbid
complications, and all adverse treatment effects.
E. How do we evaluate inflammatory bowel disease (IBD)?
1. Inflammatory bowel disease (5.06) includes, but is not
limited to, Crohn's disease and ulcerative colitis. These disorders,
while distinct entities, share many clinical, laboratory, and
imaging findings, as well as similar treatment regimens. Remissions
and exacerbations of variable duration are the hallmark of IBD.
Crohn's disease may involve the entire alimentary tract from the
mouth to the anus in a segmental, asymmetric fashion. Obstruction,
stenosis, fistulization, perineal involvement, and extraintestinal
manifestations are common. Crohn's disease is rarely curable and
recurrence may be a lifelong problem, even after surgical resection.
In contrast, ulcerative colitis only affects the colon. The
inflammatory process may be limited to the rectum, extend proximally
to include any contiguous segment, or involve the entire colon.
Ulcerative colitis may be cured by total colectomy.
2. Symptoms and signs of IBD include diarrhea, fecal
incontinence, rectal bleeding, abdominal pain, fatigue, fever,
nausea, vomiting, arthralgia, abdominal tenderness, palpable
abdominal mass (usually inflamed loops of bowel) and perineal
disease. You may also have signs or laboratory findings indicating
malnutrition, such as weight loss, edema, anemia, hypoalbuminemia,
hypokalemia, hypocalcemia, or hypomagnesemia.
3. IBD may be associated with significant extraintestinal
manifestations in a variety of body systems. These include, but are
not limited to, involvement of the eye (for example, uveitis,
episcleritis, iritis); hepatobiliary disease (for example,
gallstones, primary sclerosing cholangitis); urologic disease (for
example, kidney stones, obstructive hydronephrosis); skin
involvement (for example, erythema nodosum, pyoderma gangrenosum);
or non-destructive inflammatory arthritis. You may also have
associated thromboembolic disorders or vascular disease. These
manifestations may not correlate with the severity of your IBD. If
your impairment does not meet any of the criteria of 5.06, we will
consider the effects of your extraintestinal manifestations in
determining whether you have an impairment(s) that meets or
medically equals another listing, and we will also consider the
effects of your extraintestinal manifestations when we assess your
residual functional capacity.
4. Surgical diversion of the intestinal tract, including
ileostomy and colostomy, does not preclude any gainful activity if
you are able to maintain adequate nutrition and function of the
stoma. However, if you are not able to maintain adequate nutrition,
we will evaluate your impairment under 5.08.
F. How do we evaluate short bowel syndrome (SBS)?
[[Page 59425]]
1. Short bowel syndrome (5.07) is a disorder that occurs when
ischemic vascular insults (for example, volvulus), trauma, or IBD
complications require surgical resection of more than one-half of
the small intestine, resulting in the loss of intestinal absorptive
surface and a state of chronic malnutrition. The management of SBS
requires long-term parenteral nutrition via an indwelling central
venous catheter (central line); the process is often referred to as
hyperalimentation or total parenteral nutrition (TPN). Individuals
with SBS can also feed orally, with variable amounts of nutrients
being absorbed through their remaining intestine. Over time, some of
these individuals can develop additional intestinal absorptive
surface, and may ultimately be able to be weaned off their
parenteral nutrition.
2. Your impairment will continue to meet 5.07 as long as you
remain dependent on daily parenteral nutrition via a central venous
catheter for most of your nutritional requirements. Long-term
complications of SBS and parenteral nutrition include central line
infections (with or without septicemia), thrombosis, hepatotoxicity,
gallstones, and loss of venous access sites. Intestinal
transplantation is the only definitive treatment for individuals
with SBS who remain chronically dependent on parenteral nutrition.
3. To document SBS, we need a copy of the operative report of
intestinal resection, the summary of the hospitalization(s)
including: Details of the surgical findings, medically appropriate
postoperative imaging studies that reflect the amount of your
residual small intestine, or if we cannot get one of these reports,
other medical reports that include details of the surgical findings.
We also need medical documentation that you are dependent on daily
parenteral nutrition to provide most of your nutritional
requirements.
G. How do we evaluate weight loss due to any digestive disorder?
1. In addition to the impairments specifically mentioned in
these listings, other digestive disorders, such as esophageal
stricture, pancreatic insufficiency, and malabsorption, may result
in significant weight loss. We evaluate weight loss due to any
digestive disorder under 5.08 by using the Body Mass Index (BMI). We
also provide a criterion in 5.06B for lesser weight loss resulting
from IBD.
2. BMI is the ratio of your weight to the square of your height.
Calculation and interpretation of the BMI are independent of gender
in adults.
a. We calculate BMI using inches and pounds, meters and
kilograms, or centimeters and kilograms. We must have measurements
of your weight and height without shoes for these calculations.
b. We calculate BMI using one of the following formulas:
[GRAPHIC] [TIFF OMITTED] TR19OC07.003
[GRAPHIC] [TIFF OMITTED] TR19OC07.004
[GRAPHIC] [TIFF OMITTED] TR19OC07.005
H. What do we mean by the phrase ``consider under a disability
for 1 year''? We use the phrase ``consider under a disability for 1
year'' following a specific event in 5.02, 5.05A, and 5.09 to
explain how long your impairment can meet the requirements of those
particular listings. This phrase does not refer to the date on which
your disability began, only to the date on which we must reevaluate
whether your impairment continues to meet a listing or is otherwise
disabling. For example, if you have received a liver transplant, you
may have become disabled before the transplant because of chronic
liver disease. Therefore, we do not restrict our determination of
the onset of disability to the date of the specified event. We will
establish an onset date earlier than the date of the specified event
if the evidence in your case record supports such a finding.
I. How do we evaluate impairments that do not meet one of the
digestive disorder listings?
1. These listings are only examples of common digestive
disorders that we consider severe enough to prevent you from doing
any gainful activity. If your impairment(s) does not meet the
criteria of any of these listings, we must also consider whether you
have an impairment(s) that satisfies the criteria of a listing in
another body system. For example, if you have hepatitis B or C and
you are depressed, we will evaluate your impairment under 12.04.
2. If you have a severe medically determinable impairment(s)
that does not meet a listing, we will determine whether your
impairment(s) medically equals a listing. (See Sec. Sec. 404.1526
and 416.926.) If your impairment(s) does not meet or medically equal
a listing, you may or may not have the residual functional capacity
to engage in substantial gainful activity. In this situation, we
will proceed to the fourth, and if necessary, the fifth steps of the
sequential evaluation process in Sec. Sec. 404.1520 and 416.920.
When we decide whether you continue to be disabled, we use the rules
in Sec. Sec. 404.1594, 416.994, and 416.994a as appropriate.
5.01 Category of Impairments, Digestive System
5.02 Gastrointestinal hemorrhaging from any cause, requiring
blood transfusion (with or without hospitalization) of at least 2
units of blood per transfusion, and occurring at least three times
during a consecutive 6-month period. The transfusions must be at
least 30 days apart within the 6-month period. Consider under a
disability for 1 year following the last documented transfusion;
thereafter, evaluate the residual impairment(s).
5.03 [Reserved]
5.04 [Reserved]
5.05 Chronic liver disease, with:
A. Hemorrhaging from esophageal, gastric, or ectopic varices or
from portal hypertensive gastropathy, demonstrated by endoscopy, x-
ray, or other appropriate medically acceptable imaging, resulting in
hemodynamic instability as defined in 5.00D5, and requiring
hospitalization for transfusion of at least 2 units of blood.
Consider under a disability for 1 year
[[Page 59426]]
following the last documented transfusion; thereafter, evaluate the
residual impairment(s).
OR
B. Ascites or hydrothorax not attributable to other causes,
despite continuing treatment as prescribed, present on at least two
evaluations at least 60 days apart within a consecutive 6-month
period. Each evaluation must be documented by:
1. Paracentesis or thoracentesis; or
2. Appropriate medically acceptable imaging or physical
examination and one of the following:
a. Serum albumin of 3.0 g/dL or less; or
b. International Normalized Ratio (INR) of at least 1.5.
OR
C. Spontaneous bacterial peritonitis with peritoneal fluid
containing an absolute neutrophil count of at least 250 cells/
mm3.
OR
D. Hepatorenal syndrome as described in 5.00D8, with one of the
following:
1. Serum creatinine elevation of at least 2 mg/dL; or
2. Oliguria with 24-hour urine output less than 500 mL; or
3. Sodium retention with urine sodium less than 10 mEq per
liter.
OR
E. Hepatopulmonary syndrome as described in 5.00D9, with:
1. Arterial oxygenation (PaO2) on room air
of:
a. 60 mm Hg or less, at test sites less than 3000 feet above sea
level, or
b. 55 mm Hg or less, at test sites from 3000 to 6000 feet, or
c. 50 mm Hg or less, at test sites above 6000 feet; or
2. Documentation of intrapulmonary arteriovenous shunting by
contrast-enhanced echocardiography or macroaggregated albumin lung
perfusion scan.
OR
F. Hepatic encephalopathy as described in 5.00D10, with 1 and
either 2 or 3:
1. Documentation of abnormal behavior, cognitive dysfunction,
changes in mental status, or altered state of consciousness (for
example, confusion, delirium, stupor, or coma), present on at least
two evaluations at least 60 days apart within a consecutive 6-month
period; and
2. History of transjugular intrahepatic portosystemic shunt
(TIPS) or any surgical portosystemic shunt: or
3. One of the following occurring on at least two evaluations at
least 60 days apart within the same consecutive 6-month period as in
F1:
a. Asterixis or other fluctuating physical neurological
abnormalities; or
b. Electroencephalogram (EEG) demonstrating triphasic slow wave
activity; or
c. Serum albumin of 3.0 g/dL or less; or
d. International Normalized Ratio (INR) of 1.5 or greater.
OR
G. End stage liver disease with SSA CLD scores of 22 or greater
calculated as described in 5.00D11. Consider under a disability from
at least the date of the first score.
5.06 Inflammatory bowel disease (IBD) documented by endoscopy,
biopsy, appropriate medically acceptable imaging, or operative
findings with:
A. Obstruction of stenotic areas (not adhesions) in the small
intestine or colon with proximal dilatation, confirmed by
appropriate medically acceptable imaging or in surgery, requiring
hospitalization for intestinal decompression or for surgery, and
occurring on at least two occasions at least 60 days apart within a
consecutive 6-month period;
OR
B. Two of the following despite continuing treatment as
prescribed and occurring within the same consecutive 6-month period:
1. Anemia with hemoglobin of less than 10.0 g/dL, present on at
least two evaluations at least 60 days apart; or
2. Serum albumin of 3.0 g/dL or less, present on at least two
evaluations at least 60 days apart; or
3. Clinically documented tender abdominal mass palpable on
physical examination with abdominal pain or cramping that is not
completely controlled by prescribed narcotic medication, present on
at least two evaluations at least 60 days apart; or
4. Perineal disease with a draining abscess or fistula, with
pain that is not completely controlled by prescribed narcotic
medication, present on at least two evaluations at least 60 days
apart; or
5. Involuntary weight loss of at least 10 percent from baseline,
as computed in pounds, kilograms, or BMI, present on at least two
evaluations at least 60 days apart; or
6. Need for supplemental daily enteral nutrition via a
gastrostomy or daily parenteral nutrition via a central venous
catheter.
5.07 Short bowel syndrome (SBS), due to surgical resection of
more than one-half of the small intestine, with dependence on daily
parenteral nutrition via a central venous catheter (see 5.00F).
5.08 Weight loss due to any digestive disorder despite
continuing treatment as prescribed, with BMI of less than 17.50
calculated on at least two evaluations at least 60 days apart within
a consecutive 6-month period.
5.09 Liver transplantation. Consider under a disability for 1
year following the date of transplantation; thereafter, evaluate the
residual impairment(s) (see 5.00D12 and 5.00H).
* * * * *
0
4. Revise listing 6.02C4 in part A of appendix 1 to subpart P of part
404 to read as follows:
Appendix 1 to Subpart P of Part 404--Listing of Impairments
* * * * *
Part A
* * * * *
6.02 * * *
* * * * *
C. * * *
4. Persistent anorexia with weight loss determined by body mass
index (BMI) of less than 18.0, calculated on at least two
evaluations at least 30 days apart within a consecutive 6-month
period (see 5.00G2).
* * * * *
0
5. Revise listing 12.09G in part A of appendix 1 to subpart P of part
404 to read as follows:
Appendix 1 to Subpart P of Part 404--Listing of Impairments
* * * * *
Part A
* * * * *
12.09 * * *
* * * * *
G. Gastritis. Evaluate under 5.00.
* * * * *
0
6. Revise section 105.00 in part B of appendix 1 to subpart P of part
404 to read as follows:
Appendix 1 to Subpart P of Part 404--Listing of Impairments
* * * * *
Part B
* * * * *
105.00 DIGESTIVE SYSTEM
A. What kinds of disorders do we consider in the digestive
system? Disorders of the digestive system include gastrointestinal
hemorrhage, hepatic (liver) dysfunction, inflammatory bowel disease,
short bowel syndrome, and malnutrition. They may also lead to
complications, such as obstruction, or be accompanied by
manifestations in other body systems. Congenital abnormalities
involving the organs of the gastrointestinal system may interfere
with the ability to maintain adequate nutrition, growth, and
development.
B. What documentation do we need? We need a record of your
medical evidence, including clinical and laboratory findings. The
documentation should include appropriate medically acceptable
imaging studies and reports of endoscopy, operations, and pathology,
as appropriate to each listing, to document the severity and
duration of your digestive disorder. We may also need assessments of
your growth and development. Medically acceptable imaging includes,
but is not limited to, x-ray imaging, sonography, computerized axial
tomography (CAT scan), magnetic resonance imaging (MRI), and
radionuclide scans. Appropriate means that the technique used is the
proper one to support the evaluation and diagnosis of the disorder.
The findings required by these listings must occur within the period
we are considering in connection with your application or continuing
disability review.
C. How do we consider the effects of treatment?
1. Digestive disorders frequently respond to medical or surgical
treatment; therefore, we generally consider the severity and
duration of these disorders within the context of the prescribed
treatment.
2. We assess the effects of treatment, including medication,
therapy, surgery, or
[[Page 59427]]
any other form of treatment you receive, by determining if there are
improvements in the symptoms, signs, and laboratory findings of your
digestive disorder. We also assess any side effects of your
treatment that may further limit your functioning.
3. To assess the effects of your treatment, we may need
information about:
a. The treatment you have been prescribed (for example, the type
of medication or therapy, or your use of parenteral (intravenous)
nutrition or supplemental enteral nutrition via a gastrostomy);
b. The dosage, method, and frequency of administration;
c. Your response to the treatment;
d. Any adverse effects of such treatment; and
e. The expected duration of the treatment.
4. Because the effects of treatment may be temporary or long-
term, in most cases we need information about the impact of your
treatment, including its expected duration and side effects, over a
sufficient period of time to help us assess its outcome. When
adverse effects of treatment contribute to the severity of your
impairment(s), we will consider the duration or expected duration of
the treatment when we assess the duration of your impairment(s).
5. If you need parenteral (intravenous) nutrition or
supplemental enteral nutrition via a gastrostomy to avoid
debilitating complications of a digestive disorder, this treatment
will not, in itself, indicate that you have marked and severe
functional limitations. The exceptions are 105.07, short bowel
syndrome, and 105.10, for children who have not attained age 3 and
who require supplemental daily enteral feedings via a gastrostomy
(see 105.00F and 105.00H).
6. If you have not received ongoing treatment or have not had an
ongoing relationship with the medical community despite the
existence of a severe impairment(s), we will evaluate the severity
and duration of your digestive impairment on the basis of current
medical and other evidence in your case record. If you have not
received treatment, you may not be able to show an impairment that
meets the criteria of one of the digestive system listings, but your
digestive impairment may medically equal a listing or functionally
equal the listings.
D. How do we evaluate chronic liver disease?
1. General. Chronic liver disease is characterized by liver cell
necrosis, inflammation, or scarring (fibrosis or cirrhosis), due to
any cause, that persists for more than 6 months. Chronic liver
disease may result in portal hypertension, cholestasis (suppression
of bile flow), extrahepatic manifestations, or liver cancer. (We
evaluate liver cancer under 113.03.) Significant loss of liver
function may be manifested by hemorrhage from varices or portal
hypertensive gastropathy, ascites (accumulation of fluid in the
abdominal cavity), hydrothorax (ascitic fluid in the chest cavity),
or encephalopathy. There can also be progressive deterioration of
laboratory findings that are indicative of liver dysfunction. Liver
transplantation is the only definitive cure for end stage liver
disease (ESLD).
2. Examples of chronic liver disease include, but are not
limited to, biliary atresia, chronic hepatitis, non-alcoholic
steatohepatitis (NASH), primary biliary cirrhosis (PBC), primary
sclerosing cholangitis (PSC), autoimmune hepatitis, hemochromatosis,
drug-induced liver disease, Wilson's disease, and serum alpha-1
antitrypsin deficiency. Children can also have congenital
abnormalities of abdominal organs or inborn metabolic disorders that
result in chronic liver disease. Acute hepatic injury is frequently
reversible as in viral, drug-induced, toxin-induced, and ischemic
hepatitis. In the absence of evidence of a chronic impairment,
episodes of acute liver disease do not meet 105.05.
3. Manifestations of chronic liver disease.
a. Symptoms may include, but are not limited to, pruritis
(itching), fatigue, nausea, loss of appetite, or sleep disturbances.
Children can also have associated developmental delays or poor
school performance. Symptoms of chronic liver disease may have a
poor correlation with the severity of liver disease and functional
ability.
b. Signs may include, but are not limited to, jaundice,
enlargement of the liver and spleen, ascites, peripheral edema, and
altered mental status.
c. Laboratory findings may include, but are not limited to,
increased liver enzymes, increased serum total bilirubin, increased
ammonia levels, decreased serum albumin, and abnormal coagulation
studies, such as increased International Normalized Ratio (INR) or
decreased platelet counts. Abnormally low serum albumin or elevated
INR levels indicate loss of synthetic liver function, with increased
likelihood of cirrhosis and associated complications. However, other
abnormal lab tests, such as liver enzymes, serum total bilirubin, or
ammonia levels, may have a poor correlation with the severity of
liver disease and functional ability. A liver biopsy may demonstrate
the degree of liver cell necrosis, inflammation, fibrosis, and
cirrhosis. If you have had a liver biopsy, we will make every
reasonable effort to obtain the results; however, we will not
purchase a liver biopsy. Imaging studies (CAT scan, ultrasound, MRI)
may show the size and consistency (fatty liver, scarring) of the
liver and document ascites (see 105.00D6).
4. Chronic viral hepatitis infections.
a. General.
(i) Chronic viral hepatitis infections are commonly caused by
hepatitis C virus (HCV), and to a lesser extent, hepatitis B virus
(HBV). Usually, these are slowly progressive disorders that persist
over many years during which the symptoms and signs are typically
nonspecific, intermittent, and mild (for example, fatigue,
difficulty with concentration, or right upper quadrant pain).
Laboratory findings (liver enzymes, imaging studies, liver biopsy
pathology) and complications are generally similar in HCV and HBV.
The spectrum of these chronic viral hepatitis infections ranges
widely and includes an asymptomatic state; insidious disease with
mild to moderate symptoms associated with fluctuating liver tests;
extrahepatic manifestations; cirrhosis, both compensated and
decompensated; ESLD with the need for liver transplantation; and
liver cancer. Treatment for chronic viral hepatitis infections
varies considerably based on age, medication tolerance, treatment
response, adverse effects of treatment, and duration of the
treatment. Comorbid disorders, such as HIV infection, may affect the
clinical course of viral hepatitis infection(s) or may alter the
response to medical treatment.
(ii) We evaluate all types of chronic viral hepatitis infections
under 105.05 or any listing in an affected body system(s). If your
impairment(s) does not meet or medically equal a listing, we will
consider the effects of your hepatitis when we assess whether your
impairment(s) functionally equals the listings.
b. Chronic hepatitis B virus (HBV) infection.
(i) Chronic HBV infection is diagnosed by the detection of
hepatitis B surface antigen (HBsAg) in the blood for at least 6
months. In addition, detection of the hepatitis B envelope antigen
(HBeAg) suggests an increased likelihood of progression to cirrhosis
and ESLD.
(ii) The therapeutic goal of treatment is to suppress HBV
replication and thereby prevent progression to cirrhosis and ESLD.
Treatment usually includes a combination of interferon injections
and oral antiviral agents. Common adverse effects of treatment are
the same as noted in 105.00D4c(ii) for HCV, and generally end within
a few days after treatment is discontinued.
c. Chronic hepatitis C virus (HCV) infection.
(i) Chronic HCV infection is diagnosed by the detection of
hepatitis C viral RNA in the blood for at least 6 months.
Documentation of the therapeutic response to treatment is also
monitored by the quantitative assay of serum HCV RNA (``HCV viral
load''). Treatment usually includes a combination of interferon
injections and oral ribavirin; whether a therapeutic response has
occurred is usually assessed after 12 weeks of treatment by checking
the HCV viral load. If there has been a substantial reduction in HCV
viral load (also known as early viral response, or EVR), this
reduction is predictive of a sustained viral response with
completion of treatment. Combined therapy is commonly discontinued
after 12 weeks when there is no early viral response, since in that
circumstance there is little chance of obtaining a sustained viral
response (SVR). Otherwise, treatment is usually continued for a
total of 48 weeks.
(ii) Combined interferon and ribavirin treatment may have
significant adverse effects that may require dosing reduction,
planned interruption of treatment, or discontinuation of treatment.
Adverse effects may include: Anemia (ribavirin-induced hemolysis),
neutropenia, thrombocytopenia, fever, cough, fatigue, myalgia,
arthralgia, nausea, loss of appetite, pruritis, and insomnia.
Behavioral side effects may also occur. Influenza-like symptoms are
generally worse in the first 4 to 6 hours after each interferon
injection and during the first weeks of treatment. Adverse effects
generally end within a few days after treatment is discontinued.
[[Page 59428]]
d. Extrahepatic manifestations of HBV and HCV. In addition to
their hepatic manifestations, both HBV and HCV may have significant
extrahepatic manifestations in a variety of body systems. These
include, but are not limited to: Keratoconjunctivitis (sicca
syndrome), glomerulonephritis, skin disorders (for example, lichen
planus, porphyria cutanea tarda), neuropathy, and immune dysfunction
(for example, cryoglobulinemia, Sj[ouml]gren's syndrome, and
vasculitis). The extrahepatic manifestations of HBV and HCV may not
correlate with the severity of your hepatic impairment. If your
impairment(s) does not meet or medically equal a listing in an
affected body system(s), we will consider the effects of your
extrahepatic manifestations when we determine whether your
impairment(s) functionally equals the listings.
5. Gastrointestinal hemorrhage (105.02 and 105.05A).
Gastrointestinal hemorrhaging can result in hematemesis (vomiting of
blood), melena (tarry stools), or hematochezia (bloody stools).
Under 105.02, the required transfusions of at least 10 cc of blood/
kg of body weight must be at least 30 days apart and occur at least
three times during a consecutive 6-month period. Under 105.05A,
hemodynamic instability is diagnosed with signs such as pallor (pale
skin), diaphoresis (profuse perspiration), rapid pulse, low blood
pressure, postural hypotension (pronounced fall in blood pressure
when arising to an upright position from lying down) or syncope
(fainting). Hemorrhaging that results in hemodynamic instability is
potentially life-threatening and therefore requires hospitalization
for transfusion and supportive care. Under 105.05A, we require only
one hospitalization for transfusion of at least 10 cc of blood/kg of
body weight.
6. Ascites or hydrothorax (105.05B) indicates significant loss
of liver function due to chronic liver disease. We evaluate ascites
or hydrothorax that is not attributable to other causes under
105.05B. The required findings must be present on at least two
evaluations at least 60 days apart within a consecutive 6-month
period and despite continuing treatment as prescribed.
7. Spontaneous bacterial peritonitis (105.05C) is an infectious
complication of chronic liver disease. It is diagnosed by ascitic
peritoneal fluid that is documented to contain an absolute
neutrophil count of at least 250 cells/mm \3\. The required finding
in 105.05C is satisfied with one evaluation documenting peritoneal
fluid infection. We do not evaluate other causes of peritonitis that
are unrelated to chronic liver disease, such as tuberculosis,
malignancy, and perforated bowel, under this listing. We evaluate
these other causes of peritonitis under the appropriate body system
listings.
8. Hepatorenal syndrome (105.05D) is defined as functional renal
failure associated with chronic liver disease in the absence of
underlying kidney pathology. Hepatorenal syndrome is documented by
elevation of serum creatinine, marked sodium retention, and oliguria
(reduced urine output). The requirements of 105.05D are satisfied
with documentation of any one of the three laboratory findings on
one evaluation. We do not evaluate known causes of renal
dysfunction, such as glomerulonephritis, tubular necrosis, drug-
induced renal disease, and renal infections, under this listing. We
evaluate these other renal impairments under 106.00ff.
9. Hepatopulmonary syndrome (105.05E) is defined as arterial
deoxygenation (hypoxemia) that is associated with chronic liver
disease due to intrapulmonary arteriovenous shunting and
vasodilatation, in the absence of other causes of arterial
deoxygenation. Clinical manifestations usually include dyspnea,
orthodeoxia (increasing hypoxemia with erect position), platypnea
(improvement of dyspnea with flat position), cyanosis, and clubbing.
The requirements of 105.05E are satisfied with documentation of any
one of the findings on one evaluation. In 105.05E1, we require
documentation of the altitude of the testing facility because
altitude affects the measurement of arterial oxygenation. We will
not purchase the specialized studies described in 105.05E2; however,
if you have had these studies at a time relevant to your claim, we
will make every reasonable effort to obtain the reports for the
purpose of establishing whether your impairment meets 105.05E2.
10. Hepatic encephalopathy (105.05F).
a. General. Hepatic encephalopathy usually indicates severe loss
of hepatocellular function. We define hepatic encephalopathy under
105.05F as a recurrent or chronic neuropsychiatric disorder,
characterized by abnormal behavior, cognitive dysfunction, altered
state of consciousness, and ultimately coma and death. The diagnosis
is established by changes in mental status associated with fleeting
neurological signs, including ``flapping tremor'' (asterixis),
characteristic electroencephalographic (EEG) abnormalities, or
abnormal laboratory values that indicate loss of synthetic liver
function. We will not purchase the EEG testing described in
105.05F3b. However, if you have had this test at a time relevant to
your claim, we will make every reasonable effort to obtain the
report for the purpose of establishing whether your impairment meets
105.05F.
b. Acute encephalopathy. We will not evaluate your acute
encephalopathy under 105.05F if it results from conditions other
than chronic liver disease, such as vascular events and neoplastic
diseases. We will evaluate these other causes of acute
encephalopathy under the appropriate body system listings.
11. End stage liver disease (ESLD) documented by scores from the
SSA Chronic Liver Disease (SSA CLD) calculation (105.05G1) and SSA
Chronic Liver Disease-Pediatric (SSA CLD-P) calculation (105.05G2).
a. SSA CLD score.
(i) If you are age 12 or older, we will use the SSA CLD score to
evaluate your ESLD under 105.05G1. We explain how we calculate the
SSA CLD score in a(ii) through a(vii) of this section.
(ii) To calculate the SSA CLD score, we use a formula that
includes three laboratory values: Serum total bilirubin (mg/dL),
serum creatinine (mg/dL), and International Normalized Ratio (INR).
The formula for the SSA CLD score calculation is:
9.57 x [Loge (serum creatinine mg/dL)]
+3.78 x [Loge (serum total bilirubin mg/dL)]
+11.2 x [Loge (INR)]
+6.43
(iii) When we indicate ``Loge'' in the formula for the SSA CLD
score calculation, we mean the ``base e logarithm'' or ``natural
logarithm'' (ln) of a numerical laboratory value, not the ``base 10
logarithm'' or ``common logarithm'' (log) of the laboratory value,
and not the actual laboratory value. For an example of SSA CLD
calculation, see 5.00D11c.
(iv) For any SSA CLD score calculation, all of the required
laboratory values must have been obtained within 30 days of each
other. If there are multiple laboratory values within the 30-day
interval for any given laboratory test (serum total bilirubin, serum
creatinine, or INR), we will use the highest value for the SSA CLD
score calculation. We will round all laboratory values less than 1.0
up to 1.0.
(v) Listing 105.05G requires two SSA CLD scores. The laboratory
values for the second SSA CLD score calculation must have been
obtained at least 60 days after the latest laboratory value for the
first SSA CLD score and within the required 6-month period. We will
consider the date of each SSA CLD score to be the date of the first
laboratory value used for its calculation.
(vi) If you are in renal failure or on dialysis within a week of
any serum creatinine test in the period used for the SSA CLD
calculation, we will use a serum creatinine of 4, which is the
maximum serum creatinine level allowed in the calculation, to
calculate your SSA CLD score.
(vii) If you have the two SSA CLD scores required by 105.05G1,
we will find that your impairment meets the criteria of the listing
from at least the date of the first SSA CLD score.
b. SSA CLD-P score.
(i) If you have not attained age 12, we will use the SSA CLD-P
score to evaluate your ESLD under 105.05G2. We explain how we
calculate the SSA CLD-P score in b(ii) through b(vii) of this
section.
(ii) To calculate the SSA CLD-P score, we use a formula that
includes four parameters: Serum total bilirubin (mg/dL),
International Normalized Ratio (INR), serum albumin (g/dL), and
whether growth failure is occurring. The formula for the SSA CLD-P
score calculation is:
4.80 x [Loge (serum total bilirubin mg/dL)]
+18.57 x [Loge (INR)]
-6.87 x [Loge (serum albumin g/dL)]
+6.67 if the child has growth failure (< -2 standard deviations for
weight or height)
(iii) When we indicate ``Loge'' in the formula for the SSA CLD-P
score calculation, we mean the ``base e logarithm'' or ``natural
logarithm'' (ln) of a numerical laboratory value, not the ``base 10
logarithm'' or ``common logarithm'' (log) of the laboratory value,
and not the actual laboratory value. For example, if a female child
is 4.0 years old, has a current weight of 13.5 kg (10th percentile
for age) and height of 92 cm (less than the third percentile for
age), and has laboratory values of serum total bilirubin 2.2 mg/dL,
INR 1.0, and serum albumin 3.5 g/dL, we will compute the SSA CLD-P
score as follows:
[[Page 59429]]
4.80 x [Loge +(serum total bilirubin 2.2 mg/dL) = 0.788]
+18.57 x [Loge (INR 1.0) = 0]
-6.87 x [Loge +(serum albumin 3.5 g/dL) = 1.253]
+6.67
------
= 3.78 + 0 -8.61 + 6.67
= 1.84, which is then rounded to an SSA CLD-P score of 2
(iv) For any SSA CLD-P score calculation, all of the required
laboratory values (serum total bilirubin, INR, or serum albumin)
must have been obtained within 30 days of each other. We will not
purchase INR values for children who have not attained age 12. If
there is no INR value for a child under 12 within the applicable
time period, we will use an INR value of 1.1 to calculate the SSA
CLD-P score. If there are multiple laboratory values within the 30-
day interval for any given laboratory test, we will use the highest
serum total bilirubin and INR values and the lowest serum albumin
value for the SSA CLD-P score calculation. We will round all
laboratory values less than 1.0 up to 1.0.
(v) The weight and length/height measurements used for the
calculation must be obtained from one evaluation within the same 30-
day period as in D11b(iv).
(vi) Listing 105.05G2 requires two SSA CLD-P scores. The
laboratory values for the second SSA CLD-P score calculation must
have been obtained at least 60 days after the latest laboratory
value for the first SSA CLD-P score and within the required 6-month
period. We will consider the date of each SSA CLD-P score to be the
date of the first laboratory value used for its calculation.
(vii) If you have the two SSA CLD-P scores required by listing
105.05G2, we will find that your impairment meets the criteria of
the listing from at least the date of the first SSA CLD-P score.
12. Extrahepatic biliary atresia (EBA) (105.05H) usually
presents in the first 2 months of life with persistent jaundice. The
impairment meets 105.05H if the diagnosis of EBA is confirmed by
liver biopsy or intraoperative cholangiogram that shows obliteration
of the extrahepatic biliary tree. EBA is usually surgically treated
by portoenterostomy (for example, Kasai procedure). If this surgery
is not performed in the first months of life or is not completely
successful, liver transplantation is indicated. If you have had a
liver transplant, we will evaluate your impairment under 105.09.
13. Liver transplantation (105.09) may be performed for
metabolic liver disease, progressive liver failure, life-threatening
complications of liver disease, hepatic malignancy, and acute
fulminant hepatitis (viral, drug-induced, or toxin-induced). We will
consider you to be disabled for 1 year from the date of the
transplantation. Thereafter, we will evaluate your residual
impairment(s) by considering the adequacy of post-transplant liver
function, the requirement for post-transplant antiviral therapy, the
frequency and severity of rejection episodes, comorbid
complications, and all adverse treatment effects.
E. How do we evaluate inflammatory bowel disease (IBD)?
1. Inflammatory bowel disease (105.06) includes, but is not
limited to, Crohn's disease and ulcerative colitis. These disorders,
while distinct entities, share many clinical, laboratory, and
imaging findings, as well as similar treatment regimens. Remissions
and exacerbations of variable duration are the hallmark of IBD.
Crohn's disease may involve the entire alimentary tract from the
mouth to the anus in a segmental, asymmetric fashion. Obstruction,
stenosis, fistulization, perineal involvement, and extraintestinal
manifestations are common. Crohn's disease is rarely curable and
recurrence may be a lifelong problem, even after surgical resection.
In contrast, ulcerative colitis only affects the colon. The
inflammatory process may be limited to the rectum, extend proximally
to include any contiguous segment, or involve the entire colon.
Ulcerative colitis may be cured by total colectomy.
2. Symptoms and signs of IBD include diarrhea, fecal
incontinence, rectal bleeding, abdominal pain, fatigue, fever,
nausea, vomiting, arthralgia, abdominal tenderness, palpable
abdominal mass (usually inflamed loops of bowel) and perineal
disease. You may also have signs or laboratory findings indicating
malnutrition, such as weight loss, edema, anemia, hypoalbuminemia,
hypokalemia, hypocalcemia, or hypomagnesemia.
3. IBD may be associated with significant extraintestinal
manifestations in a variety of body systems. These include, but are
not limited to, involvement of the eye (for example, uveitis,
episcleritis, iritis); hepatobiliary disease (for example,
gallstones, primary sclerosing cholangitis); urologic disease (for
example, kidney stones, obstructive hydronephrosis); skin
involvement (for example, erythema nodosum, pyoderma gangrenosum);
or non-destructive inflammatory arthritis. You may also have
associated thromboembolic disorders or vascular disease. These
manifestations may not correlate with the severity of your IBD. If
your impairment does not meet any of the criteria of 105.06, we will
consider the effects of your extraintestinal manifestations in
determining whether you have an impairment(s) that meets or
medically equals another listing, and we will also consider the
effects of your extraintestinal manifestations when we determine
whether your impairment(s) functionally equals the listings.
4. Surgical diversion of the intestinal tract, including
ileostomy and colostomy, does not very seriously interfere with age-
appropriate functioning if you are able to maintain adequate
nutrition and function of the stoma. However, if you are not able to
maintain adequate nutrition, we will evaluate your impairment under
105.08.
F. How do we evaluate short bowel syndrome (SBS)?
1. Short bowel syndrome (105.07) is a disorder that occurs when
congenital intestinal abnormalities, ischemic vascular insults (for
example, necrotizing enterocolitis, volvulus), trauma, or IBD
complications require surgical resection of more than one-half of
the small intestine, resulting in the loss of intestinal absorptive
surface and a state of chronic malnutrition. The management of SBS
requires long-term parenteral nutrition via an indwelling central
venous catheter (central line); the process is often referred to as
hyperalimentation or total parenteral nutrition (TPN). Children with
SBS can also feed orally, with variable amounts of nutrients being
absorbed through their remaining intestine. Over time, some of these
children can develop additional intestinal absorptive surface, and
may ultimately be able to be weaned off their parenteral nutrition.
2. Your impairment will continue to meet 105.07 as long as you
remain dependent on daily parenteral nutrition via a central venous
catheter for most of your nutritional requirements. Long-term
complications of SBS and parenteral nutrition include abnormal
growth rates, central line infections (with or without septicemia),
thrombosis, hepatotoxicity, gallstones, and loss of venous access
sites. Intestinal transplantation is the only definitive treatment
for children with SBS who remain chronically dependent on parenteral
nutrition.
3. To document SBS, we need a copy of the operative report of
intestinal resection, the summary of the hospitalization(s)
including: Details of the surgical findings, medically appropriate
postoperative imaging studies that reflect the amount of your
residual small intestine, or if we cannot get one of these reports,
other medical reports that include details of the surgical findings.
We also need medical documentation that you are dependent on daily
parenteral nutrition to provide most of your nutritional
requirements.
G. How do we evaluate malnutrition in children?
1. Many types of digestive disorders can result in malnutrition
and growth retardation. To meet the malnutrition criteria in
105.08A, we need documentation of a digestive disorder with
associated chronic nutritional deficiency despite prescribed
treatment.
2. We evaluate the growth retardation criteria in 105.08B by
using the most recent growth charts by the Centers for Disease
Control and Prevention (CDC).
a. If you have not attained age 2, we use weight-for-length
measurements to assess whether your impairment meets the requirement
of 105.08B1. CDC weight-for-length charts are age- and gender-
specific.
b. If you are a child age 2 or older, we use BMI-for-age
measurements to assess whether your impairment meets the requirement
of 105.08B2. BMI is the ratio of your weight to the square of your
height. BMI-for-age is plotted on the CDC's gender-specific growth
charts.
c. We calculate BMI using inches and pounds, meters and
kilograms, or centimeters and kilograms. We must have measurements
of your weight and height without shoes for these calculations.
d. We calculate BMI using one of the following formulas:
[[Page 59430]]
[GRAPHIC] [TIFF OMITTED] TR19OC07.003
[GRAPHIC] [TIFF OMITTED] TR19OC07.004
[GRAPHIC] [TIFF OMITTED] TR19OC07.005
H. How do we evaluate the need for supplemental daily enteral
feeding via a gastrostomy?
1. General. Infants and young children may have anatomical,
neurological, or developmental disorders that interfere with their
ability to feed by mouth, resulting in inadequate caloric intake to
meet their growth needs. These disorders frequently result in the
medical necessity to supplement caloric intake and to bypass the
anatomical feeding route of mouth-throat-esophagus into the stomach.
2. Children who have not attained age 3 and who require
supplemental daily enteral nutrition via a feeding gastrostomy meet
105.10 regardless of the medical reason for the gastrostomy.
Thereafter, we evaluate growth impairment under 100.02, malnutrition
under 105.08, or other medical or developmental disorder(s)
(including the disorder(s) that necessitated gastrostomy placement)
under the appropriate listing(s).
I. How do we evaluate esophageal stricture or stenosis?
Esophageal stricture or stenosis (narrowing) from congenital atresia
(absence or abnormal closure of a tubular body organ) or destructive
esophagitis may result in malnutrition or the need for gastrostomy
placement, which we evaluate under 105.08 or 105.10. Esophageal
stricture or stenosis may also result in complications such as
pneumonias due to frequent aspiration, or difficulty in maintaining
nutritional status short of listing-level severity. While none of
these complications may be of such severity that they would meet the
criteria of another listing, the combination of impairments may
medically equal the severity of a listing or functionally equal the
listings.
J. What do we mean by the phrase ``consider under a disability
for 1 year''? We use the phrase ``consider under a disability for 1
year'' following a specific event in 105.02, 105.05A, and 105.09 to
explain how long your impairment can meet the requirements of those
particular listings. This phrase does not refer to the date on which
your disability began, only to the date on which we must reevaluate
whether your impairment continues to meet a listing or is otherwise
disabling. For example, if you have received a liver transplant, you
may have become disabled before the transplant because of chronic
liver disease. Therefore, we do not restrict our determination of
the onset of disability to the date of the specified event. We will
establish an onset date earlier than the date of the specified event
if the evidence in your case record supports such a finding.
K. How do we evaluate impairments that do not meet one of the
digestive disorder listings?
1. These listings are only examples of common digestive
disorders that we consider severe enough to result in marked and
severe functional limitations. If your impairment(s) does not meet
the criteria of any of these listings, we must also consider whether
you have an impairment(s) that satisfies the criteria of a listing
in another body system. For example:
a. If you have hepatitis B or C and you are depressed, we will
evaluate your impairment under 112.04.
b. If you have multiple congenital abnormalities, we will
evaluate your impairment(s) under the criteria in the listings for
impairments that affect multiple body systems (110.00) or the
criteria of listings in other affected body systems.
c. If you have digestive disorders that interfere with intake,
digestion, or absorption of nutrition, and result in a reduction in
your rate of growth, and your impairment does not satisfy the
criteria in the malnutrition listing (105.08), we will evaluate your
impairment under the growth impairment listings (100.00).
2. If you have a severe medically determinable impairment(s)
that does not meet a listing, we will determine whether your
impairment(s) medically equals a listing. (See Sec. 416.926.) If
your impairment(s) does not meet or medically equal a listing, you
may or may not have an impairment(s) that functionally equals the
listings. (See Sec. 416.926a.) When we decide whether you continue
to be disabled, we use the rules in Sec. 416.994a.
105.01 Category of Impairments, Digestive System
105.02 Gastrointestinal hemorrhaging from any cause, requiring
blood transfusion (with or without hospitalization) of at least 10
cc of blood/kg of body weight, and occurring at least three times
during a consecutive 6-month period. The transfusions must be at
least 30 days apart within the 6-month period. Consider under a
disability for 1 year following the last documented transfusion;
thereafter, evaluate the residual impairment(s).
105.03 [Reserved]
105.04 [Reserved]
105.05 Chronic liver disease, with:
A. Hemorrhaging from esophageal, gastric, or ectopic varices or
from portal hypertensive gastropathy, demonstrated by endoscopy, x-
ray, or other appropriate medically acceptable imaging, resulting in
hemodynamic instability as defined in 105.00D5, and requiring
hospitalization for transfusion of at least 10 cc of blood/kg of
body weight. Consider under a disability for 1 year following the
last documented transfusion; thereafter, evaluate the residual
impairment(s).
OR
B. Ascites or hydrothorax not attributable to other causes,
despite continuing treatment as prescribed, present on at least two
evaluations at least 60 days apart within a consecutive 6-month
period. Each evaluation must be documented by:
1. Paracentesis or thoracentesis; or
2. Appropriate medically acceptable imaging or physical
examination and one of the following:
a. Serum albumin of 3.0 g/dL or less; or
b. International Normalized Ratio (INR) of at least 1.5.
OR
C. Spontaneous bacterial peritonitis with peritoneal fluid
containing an absolute neutrophil count of at least 250 cells/mm
3.
OR
[[Page 59431]]
D. Hepatorenal syndrome as described in 105.00D8, with one of
the following:
1. Serum creatinine elevation of at least 2 mg/dL; or
2. Oliguria with 24-hour urine output less than 1 mL/kg/hr; or
3. Sodium retention with urine sodium less than 10 mEq per
liter.
OR
E. Hepatopulmonary syndrome as described in 105.00D9, with:
1. Arterial oxygenation (PaO2,) on room
air of:
a. 60 mm Hg or less, at test sites less than 3000 feet above sea
level, or
b. 55 mm Hg or less, at test sites from 3000 to 6000 feet, or
c. 50 mm Hg or less, at test sites above 6000 feet; or
2. Documentation of intrapulmonary arteriovenous shunting by
contrast-enhanced echocardiography or macroaggregated albumin lung
perfusion scan.
OR
F. Hepatic encephalopathy as described in 105.00D10, with 1 and
either 2 or 3:
1. Documentation of abnormal behavior, cognitive dysfunction,
changes in mental status, or altered state of consciousness (for
example, confusion, delirium, stupor, or coma), present on at least
two evaluations at least 60 days apart within a consecutive 6-month
period; and
2. History of transjugular intrahepatic portosystemic shunt
(TIPS) or any surgical portosystemic shunt; or
3. One of the following occurring on at least two evaluations at
least 60 days apart within the same consecutive 6-month period as in
F1:
a. Asterixis or other fluctuating physical neurological
abnormalities; or
b. Electroencephalogram (EEG) demonstrating triphasic slow wave
activity; or
c. Serum albumin of 3.0 g/dL or less; or
d. International Normalized Ratio (INR) of 1.5 or greater.
OR
G. End Stage Liver Disease, with:
1. For children 12 years of age or older, SSA CLD scores of 22
or greater calculated as described in 105.00D11a. Consider under a
disability from at least the date of the first score.
2. For children who have not attained age 12, SSA CLD-P scores
of 11 or greater calculated as described in 105.00D11b. Consider
under a disability from at least the date of the first score.
OR
H. Extrahepatic biliary atresia as diagnosed on liver biopsy or
intraoperative cholangiogram. Consider under a disability for 1 year
following the diagnosis; thereafter, evaluate the residual liver
function.
105.06 Inflammatory bowel disease (IBD) documented by endoscopy,
biopsy, appropriate medically acceptable imaging, or operative
findings with:
A. Obstruction of stenotic areas (not adhesions) in the small
intestine or colon with proximal dilatation, confirmed by
appropriate medically acceptable imaging or in surgery, requiring
hospitalization for intestinal decompression or for surgery, and
occurring on at least two occasions at least 60 days apart within a
consecutive 6-month period;
OR
B. Two of the following despite continuing treatment as
prescribed and occurring within the same consecutive 6-month period:
1. Anemia with hemoglobin less than 10.0 g/dL, present on at
least two evaluations at least 60 days apart; or
2. Serum albumin of 3.0 g/dL or less, present on at least two
evaluations at least 60 days apart; or
3. Clinically documented tender abdominal mass palpable on
physical examination with abdominal pain or cramping that is not
completely controlled by prescribed narcotic medication, present on
at least two evaluations at least 60 days apart; or
4. Perineal disease with a draining abscess or fistula, with
pain that is not completely controlled by prescribed narcotic
medication, present on at least two evaluations at least 60 days
apart; or
5. Need for supplemental daily enteral nutrition via a
gastrostomy or daily parenteral nutrition via a central venous
catheter. (See 105.10 for children who have not attained age 3.)
105.07 Short bowel syndrome (SBS), due to surgical resection of
more than one-half of the small intestine, with dependence on daily
parenteral nutrition via a central venous catheter (see 105.00F).
105.08 Malnutrition due to any digestive disorder with:
A. Chronic nutritional deficiency despite continuing treatment
as prescribed, present on at least two evaluations at least 60 days
apart within a consecutive 6-month period, and documented by one of
the following:
1. Anemia with hemoglobin less than 10.0 g/dL; or
2. Serum albumin of 3.0 g/dL or less; or
3. Fat-soluble vitamin, mineral, or trace mineral deficiency;
AND
B. Growth retardation documented by one of the following:
1. For children who have not attained age 2, multiple weight-
for-length measurements that are less than the third percentile on
the CDC's most recent weight-for-length growth charts, documented at
least three times within a consecutive 6-month period; or
2. For children age 2 and older, multiple Body Mass Index (BMI)-
for-age measurements that are less than the third percentile on the
CDC's most recent BMI-for-age growth charts, documented at least
three times within a consecutive 6-month period.
105.09 Liver transplantation. Consider under a disability for 1
year following the date of transplantation; thereafter, evaluate the
residual impairment(s) (see 105.00D13 and 105.00J).
105.10 Need for supplemental daily enteral feeding via a
gastrostomy due to any cause, for children who have not attained age
3; thereafter, evaluate the residual impairment(s) (see 105.00H).
* * * * *
PART 416--SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND
DISABLED
Subpart I--[Amended]
0
7. Revise the authority citation for subpart I of part 416 to read as
follows:
Authority: Secs. 221(m), 702(a)(5), 1611, 1614, 1619, 1631(a),
(c), (d)(1), and (p) and 1633 of the Social Security Act (42 U.S.C.
421(m), 902(a)(5), 1382, 1382c, 1382h, 1383(a), (c), (d)(1), and
(p), and 1383b); secs. 4(c) and 5, 6(c)-(e), 14(a), and 15, Pub. L.
98-460, 98 Stat. 1794, 1801, 1802, and 1808 (42 U.S.C. 421 note, 423
note, and 1382h note).
Sec. 416.924b [Amended]
0
8. In Sec. 416.924b(b)(3), remove the reference ``Sec. 416.924a(m)(7)
or (8)'' and insert the reference ``Sec. 416.926a(m)(6) or (7)'' in
its place.
Sec. 416.926a [Amended]
0
9. In Sec. 416.926a, remove paragraphs (m)(3) and (m)(10) and
redesignate paragraphs (m)(4), (m)(5), (m)(6), (m)(7), (m)(8), and
(m)(9) as paragraphs (m)(3), (m)(4), (m)(5), (m)(6), (m)(7), and
(m)(8).
[FR Doc. E7-20235 Filed 10-18-07; 8:45 am]
BILLING CODE 4191-02-P