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pdfFederal Register / Vol. 66, No. 220 / Wednesday, November 14, 2001 / Proposed Rules
regulatory evaluation prepared for this
action has been placed in the Rules
Docket. A copy of it may be obtained by
contacting the Rules Docket at the
location provided under the caption
ADDRESSES.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation
safety, Safety.
The Proposed Amendment
Federal Aviation Regulations (14 CFR
part 39) as follows:
PART 39—AIRWORTHINESS
DIRECTIVES
1. The authority citation for part 39
continues to read as follows:
Authority: 49 U.S.C. 106(g), 40113, 44701.
§ 39.13
[Amended]
2. FAA amends § 39.13 by adding a
new airworthiness directive (AD) to
read as follows:
Accordingly, under the authority
delegated to me by the Administrator,
the Federal Aviation Administration
proposes to amend part 39 of the
SOCATA—Groupe Aerospatiale: Docket No.
2001–CE–10AD
57009
(a) What airplanes are affected by this AD?
This AD affects Model TBM 700 airplanes,
serial numbers 1 through 164, that are
certificated in any category.
(b) Who must comply with this AD?
Anyone who wishes to operate any of the
above airplanes must comply with this AD.
(c) What problem does this AD address?
The actions specified by this AD are intended
to prevent water from accumulating in the
fuselage, then freezing and interfering with or
causing the elevator controls to seize. This
could result in loss of elevator control with
consequent loss of airplane control.
(d) What actions must I accomplish to
address this problem? To address this
problem, you must accomplish the following:
Actions
Compliance
Procedures
Incorporate Kit No. OPT70 K072–53 ................
Within the next 3 months after the effective
date of this AD, unless already accomplished.
In accordance with the Technical Instructions
supplied with Kit No. OPT70 KO72–53, as
specified in Socata. Service Bulletin SB 70–
082 53, dated June 2000.
(e) Can I comply with this AD in any other
way? You may use an alternative method of
compliance or adjust the compliance time if:
(1) Your alternative method of compliance
provides an equivalent level of safety; and
(2) The Manager, Small Airplane
Directorate, approves your alternative.
Submit your request through an FAA
Principal Maintenance Inspector, who may
add comments and then send it to the
Manager, Small Airplane Directorate.
Note 1: This AD applies to each airplane
identified in paragraph (a) of this AD,
regardless of whether it has been modified,
altered, or repaired in the area subject to the
requirements of this AD. For airplanes that
have been modified, altered, or repaired so
that the performance of the requirements of
this AD is affected, the owner/operator must
request approval for an alternative method of
compliance in accordance with paragraph (e)
of this AD. The request should include an
assessment of the effect of the modification,
alteration, or repair on the unsafe condition
addressed by this AD; and, if you have not
eliminated the unsafe condition, specific
actions you propose to address it.
(f) Where can I get information about any
already-approved alternative methods of
compliance? Contact Karl Schletzbaum,
Aerospace Engineer, FAA, Small Airplane
Directorate, 901 Locust, Room 301, Kansas
City, Missouri 64106; telephone: (816) 329–
4146; facsimile: (816) 329–4090.
(g) What if I need to fly the airplane to
another location to comply with this AD? The
FAA can issue a special flight permit under
sections 21.197 and 21.199 of the Federal
Aviation Regulations (14 CFR 21.197 and
21.199) to operate your airplane to a location
where you can accomplish the requirements
of this AD.
(h) How do I get copies of the documents
referenced in this AD? You may get copies of
the documents referenced in this AD from
SOCATA-Groupe AEROSPATIALE,
Customer Support, Aerodrome Tarbes-OssunLourdes, BP 930—F65009 Tarbes Cedex,
France; telephone: (33) (0)5.62.41.73.00;
facsimile: (33) (0)5.62.41.76.54; or the
Product Support Manager, SOCATA—
Groupe AEROSPATIALE, North Perry
Airport, 7501 Pembroke Road, Pembroke
Pines, Florida 33023; telephone: (954) 894–
1160; facsimile: (954) 964–4191. You may
view these documents at FAA, Central
Region, Office of the Regional Counsel, 901
Locust, Room 506, Kansas City, Missouri
64106.
Note 2: The subject of this AD is addressed
in French AD 2000–373(A), dated October
18, 2000.
in medical knowledge, treatment, and
methods of evaluating digestive
impairments. We also propose to
remove listings that are redundant and
only refer to other listings.
DATES: To be sure your comments are
considered, we must receive them by
January 14, 2002.
ADDRESSES: You may give us your
comments by using: our Internet site
facility (i.e., Social Security Online) at
http://www.ssa.gov/regulations/
index.htm, e-mail to
[email protected], telefax to (410)
966–2830 or by sending a letter to the
Commissioner of Social Security, P.O.
Box 17703, Baltimore, Maryland 21235–
7703. You may also deliver them to the
Office of Process and Innovation
Management, Social Security
Administration, L2109 West Low Rise
Building, 6401 Security Boulevard,
Baltimore, Maryland 21235–6401,
between 8 a.m. and 4 p.m. on regular
business days. We post comments on
our Internet site, or you may inspect
them on regular business days by
making arrangements with the contact
person shown in this preamble.
A list of the sources we consulted
when developing these proposed rules,
e.g., various medical texts and pertinent
articles, will be posted on the above
Internet site. The list is also available
upon request by letter to the Office of
Disability, Division of Medical &
Vocational Policy, Social Security
Administration, 3√A–8 Operations
Building, 6401 Security Boulevard,
Baltimore, MD 21235, Attn: Cheryl
Wrobel, or by email to
[email protected]. Electronic
Version: The electronic file of this
document is available on the date of
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Issued in Kansas City, Missouri, on
November 5, 2001.
Michael Gallagher,
Manager, Small Airplane Directorate, Aircraft
Certification Service.
[FR Doc. 01–28420 Filed 11–13–01; 8:45 am]
BILLING CODE 4910–13–P
SOCIAL SECURITY ADMINISTRATION
20 CFR Part 404
[Regulations No. 4]
RIN 0960–AF28
Revised Medical Criteria for Evaluating
Impairments of the Digestive System
Social Security Administration.
Proposed rules.
AGENCY:
ACTION:
SUMMARY: We are proposing to revise the
criteria in the Listing of Impairments
(the Listings) that we use to evaluate
claims involving digestive impairments.
We apply these criteria at step three of
our sequential evaluation processes
when you claim benefits based on
disability under title II and title XVI of
the Social Security Act (the Act). The
proposed revisions will reflect advances
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Federal Register / Vol. 66, No. 220 / Wednesday, November 14, 2001 / Proposed Rules
publication in the Federal Register on
http://www.access.gpo.gov/su_docs/
aces/aces140.html. It is also available
on the Internet site for SSA (i.e., Social
Security Online): http://www.ssa.gov/
regulations/. Electronic copies of the
public comments on these proposed
rules may also be found on this site.
FOR FURTHER INFORMATION CONTACT:
Suzanne DiMarino, Social Insurance
Specialist, Office of Process and
Innovation Management, Social Security
Administration, 2109 West Low Rise,
6401 Security Boulevard, Baltimore,
Maryland 21235–6401, (410) 965–1769
or TTY (410) 966–5609. For information
on eligibility or filing for benefits, call
our national toll-free number 1–800–
772–1213 or TTY 1–800–325–0778, or
visit our Internet web site, SSA Online,
at www.ssa.gov.
SUPPLEMENTARY INFORMATION:
What Programs Would These Proposed
Regulations Affect?
These proposed regulations would
affect disability determinations and
decisions we make for you under title II
and title XVI of the Act. In addition, to
the extent that Medicare and Medicaid
eligibility are based on entitlement to
benefits under title II and eligibility for
benefits under title XVI, these proposed
regulations would also affect the
Medicare and Medicaid programs.
Who Can Get Disability Benefits?
Under title II of the Act, we provide
for the payment of disability benefits if
you are disabled and belong to one of
the following three groups:
• Workers insured under the Act;
And you are * * *
title II ................................................
title XVI ............................................
title XVI ............................................
an adult or child .............................
an adult ..........................................
a child ............................................
The Listings, found in appendix 1 to
subpart P of part 404 of our regulations,
are examples of impairments for each of
the major body systems that we consider
severe enough to preclude you as an
adult from performing any gainful
activity, without further considering
their functional impact or your age,
education and work experience. If you
are a child seeking SSI benefits based on
disability, the listings describe
impairments that we consider severe
enough to result in marked and severe
functional limitations. We generally use
the criteria in the Listings only to make
findings of disability. Although the
Listings are found only in part 404 of
our rules, we incorporate them into the
SSI program under title XVI of the Act
by § 416.925 of our regulations, and
apply them to claims under both title II
and title XVI of the Act.
There are listings for adults (part A)
and for children (part B). We apply the
medical criteria in part A when we
assess your claim if you are an adult,
i.e., a person age 18 or over. If you are
a child, we first use the criteria in part
B. If the B criteria do not apply, and the
specific disease process(es) has a similar
effect on adults and children, we then
use the criteria in part A.
Our regulations provide for sequential
evaluation processes for evaluating
disability. We apply the Listings at step
three of the sequential evaluation
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Why Are We proposing To revise the
Listings for Digestive Impairments?
We have reviewed the existing
digestive listings and have determined
they should be revised in light of
medical advances in evaluation and
treatment. We last published final rules
revising the digestive listings in the
Federal Register on December 6, 1985
(50 FR 50068). In the preamble to those
rules, we said that due to medical
advances in treatment and program
experience, we would periodically
review and update the Listings. The
current listings for the digestive system
will no longer be effective on July 2,
2003. We are now proposing to revise
the listings in Part A, 5.00 and in Part
B, 105.00. We are proposing to make the
rules effective for five years from the
effective date of the final rules we
publish in the Federal Register, unless
we extend them, or revise and issue
them again.
We will continue to apply our current
listings until we evaluate the public
Frm 00010
Under both the title II and title XVI
programs, disability must be the result
of any medically determinable physical
or mental impairment or combination of
impairments that can be expected to
result in death or that has lasted or can
be expected to last for a continuous
period of at least 12 months. Our
definitions of disability are shown in
the following table:
the inability to do any substantial gainful activity (SGA).
the inability to do any SGA.
marked and severe functional limitations.
processes for adults and for children.
First, we must determine that you are
not engaging in substantial gainful
activity, and, second, that you have a
medically determinable impairment or
combination of impairments that is
‘‘severe.’’
Then, at step 3 of both processes, we
use the Listings to determine if you have
an impairment(s) that meets or equals in
severity the criteria of a listed
impairment.
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How Do We Define Disability?
Disability means you have a medically determinable impairment(s)
that meets the statutory duration requirement and results in * * *
If you file a claim under * * *
What Are the Listings and How Do We
Use Them?
• Children of insured workers; and
• Widows, widowers, and surviving
divorced spouses of insured
individuals.
Under title XVI of the Act, we provide
for Supplemental Security Income (SSI)
payments on the basis of disability if
you have limited income and resources.
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comments on these proposed rules and
determine whether they should be
issued as final rules. If we finalize these
proposed rules, when any final rules
become effective, we will apply them to
new applications filed on or after the
effective date of the final rules, and to
cases that are pending in the
administrative review process. In
accordance with our usual practice, we
would explain how we would apply any
final rules in greater detail in the
preamble to the final rules.
When we conduct reviews to
determine whether your disability
continues, we would not find that your
disability has ended based only on any
changes in the listings. Our regulations
explain that we continue to use our
prior listings when we review your case
if you receive disability benefits or SSI
payments based on our determination or
decision that your impairment(s) met or
equaled the listings. In these cases, we
determine whether you have
experienced medical improvement, and
if so, whether the medical improvement
is related to the ability to work. If your
impairment(s) still meets or equals the
same listing section that we used to
make our most recent favorable
determination or decision, we will find
the medical improvement is not related
to the ability to work. If your condition
has medically improved so that you no
longer meet or equal the prior listing,
we evaluate your case further to
determine whether you are currently
disabled. We may find that you are
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Federal Register / Vol. 66, No. 220 / Wednesday, November 14, 2001 / Proposed Rules
currently disabled, depending on the
full circumstances of your case. See 20
CFR 404.1594(c)(3)(i),
416.994(b)(2)(iv)(A). If you are a child
who is eligible for SSI payments, we
follow a similar rule when we decide
whether you have experienced medical
improvement in your condition. 20 CFR
416.994a(b)(2).
What General Revisions Are We
Proposing for the Digestive System
Listings?
We propose to clarify the listing
criteria and to make the listings easier
to use by:
1. Replacing reference listings with
guidance in the preface. Reference
listings are listings that are met by
satisfying the criteria of another listing.
For example, you can meet current
listing 5.03, Stricture, stenosis, or
obstruction of the esophagus, with
weight loss as described under listing
5.08. Current listing 5.08 requires
weight loss to a specific amount due to
any persisting gastrointestinal disorder.
Therefore current listing 5.03 is
redundant.
We also propose to provide general
guidance in the preface to the listings
(see Section 5.00E1) stating that
digestive disorders resulting in
impairments in other body systems
should be evaluated under the affected
body system. We propose to list the
most commonly affected body systems.
2. Making nonsubstantive editorial
changes to update the medical
terminology in the Listings and to be
consistent with plain language
guidelines. Plain language regulations
will make the content easier to
understand.
We discuss other specific changes we
propose to make in the listings below,
in our detailed explanation of the
proposed listings.
How Are We Proposing to Change the
Preface to the Listings for Evaluating
Digestive Impairments in Adults?
5.00
Digestive System
We propose to revise the preface to
provide additional guidance for
adjudicating digestive impairments, and
to update the medical terminology. We
also propose to remove references to
disorders and complications of diseases
that we no longer always consider to
result in listing-level severity, e.g.,
peptic ulcer disease, fistulae, abscesses,
or recurrent obstructions.
The remaining relevant material in
current section 5.00A is in proposed
section 5.00A, while the relevant
material in current 5.00B is updated and
moved to proposed section 5.00F.
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The relevant material in current
section 5.00C is moved to proposed
section 5.00A. We propose to remove
that portion of current section 5.00C
that deals with peptic ulcer disease
because advances in diagnosis,
evaluation and treatment of this
impairment make the surgical
interventions discussed in the current
section (including gastrectomy,
vagotomy and pyloroplasty) much less
common.
Following is a detailed explanation,
section-by-section, of the proposed
revised preface material.
Proposed 5.00A—What Kind of
Impairments Do We Consider in the
Digestive System?
In this section, we propose to list
examples of major digestive
impairments reflected in the digestive
listings. We propose to move the
information about colostomy and
ileostomy from current section 5.00C to
proposed section 5.00A. as part of a
general reorganization of the material.
The proposed rules continue to
recognize that digestive impairments
frequently respond to medical or
surgical therapy. As a result, the
severity of these disorders should
generally be considered within the
context of prescribed treatment.
Proposed 5.00B—What Documentation
Do We Need?
In this new section, we propose to
add examples of the types of clinical
and laboratory findings that should be
part of the longitudinal evidence. We
also state that we usually need
longitudinal evidence covering a period
of at least 6 months of observations and
treatment, unless we can make a fully
favorable determination or decision
without it. With advances in medication
and treatment, favorable response to
treatment may reduce the functional
impact of digestive impairments. We
believe the 6-month evidence period
should allow sufficient time for your
impairment to stabilize so we can make
an accurate projection regarding its
severity and duration. However, this
does not prevent us from making a
finding of disability before the 6-month
period elapses, after considering all of
the medical and other evidence. The
rules we have proposed will provide us
with flexibility to address situations in
which your medical condition is so
severe that we can determine before the
6-month period elapses that your
impairment(s) will continue to be
disabling for at least 12 months. One
example would be under listing 5.02,
recurrent gastrointestinal hemorrhage, if
3 distinct episodes are documented in
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57011
less than 6 months. Another example
would be an impairment that meets
listing 5.09 Liver transplant, due to a
traumatic event or previously
unrecognized and untreated liver
condition with little or no pre-surgical
treatment documentation.
We also provide guidance on those
situations when you have not received
ongoing treatment or do not have an
ongoing relationship with the medical
community despite the existence of a
severe impairment.
Proposed 5.00C—How Do We Evaluate
Digestive Disorders Under Listings That
Require Recurring or Persistent
Findings?
We propose this new section to
discuss the requirement for recurring or
persistent findings in listings 5.02, 5.05,
5.06 and 5.08, and other considerations
which allow us to make findings
regarding continued impairment
severity to satisfy the duration of
disability requirement.
We also discuss the events and
episodes needed to meet certain listings.
There are no minimal periods of time
for which an episode has to last,
although for some listings, all incidents
within a specified period will constitute
one episode. The duration of an episode
is controlled by the requirements that
constitute an episode for a specific
disorder. For example, the requirement
for blood transfusion inherently implies
that you must seek medical care that
results in the appropriate clinical and
laboratory evaluation to determine that
transfusion is necessary.
The required number of recurrent
episodes is specified in each listing.
Listings 5.02, 5.06, 105.05A, and
105.06A are characterized by
‘‘episodes.’’
Listing 5.02 requires 3 episodes of
gastrointestinal hemorrhage requiring at
least two units of blood transfused per
episode, occurring during a consecutive
6-month period. Listing 5.02 further
qualifies that all incidents occurring
within a consecutive 14-day period
constitute one episode. Listing 5.06 and
105.06A require documentation of at
least two episodes of abdominal pain,
distention, and vomiting as a result of
inflammatory bowel disease, which is
documented as required in the listing.
These episodes must occur during the
consecutive 6-month period of
persistent or recurrent intestinal
obstruction that occurs despite
prescribed treatment. Listing 105.05A
requires 3 episodes of bleeding
requiring transfusion due to
hemodynamic instability, occurring
over a consecutive 6-month period.
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Section 5.00C2 and 105.00C2 explain:
* * * In every listing in which we
require more than one event, there must
be at least 1 month between the events
(unless otherwise specified), to ensure
that we are evaluating separate
episodes.’’
Proposed 5.00D—How Do We Consider
the Effects of Treatment?
We propose this new section to
describe our policy on assessing the
effects of treatment when we determine
the severity and duration of the
impairment.
Proposed 5.00E—How Do We Evaluate
Impairments That Do Not Meet One of
the Digestive Listings?
In this new section, we propose
guidance for assessing digestive
impairments that do not meet the
digestive listings, but are accompanied
by systemic manifestations in other
body systems. For example, we site
hepatic encephalopathy to explain that
the resultant impairment should be
evaluated under the affected body
system. This replaces the criteria in
current listing 5.05E, which states the
impairment should be evaluated under
the criteria in listing 12.02.
We also explain how evaluation of the
impairment(s) will continue through the
sequential evaluation process.
Proposed 5.00F—What Are Our
Guidelines for Evaluating Specific
Digestive Impairments?
We incorporated and revised the
guidance in current 5.00B into this
proposed section. We removed the
discussion in current section 5.00B
about a distinction between primary and
secondary digestive disorders resulting
in weight loss and malnutrition since
the distinction is not necessary for
adjudication. Rather, the weight loss
must only be shown to be related to a
digestive impairment. When a medically
determinable impairment is established,
we do not require that a direct
connection with a specific etiology be
determined. The wording in current
5.00B can be incorrectly interpreted to
imply that we must determine that the
digestive disorder is the primary or
secondary cause of the weight loss.
Since this is not necessary for our
disability evaluation process, we
propose to revise the section. If you
have a digestive disorder that can
reasonably be expected to lead to weight
loss, or a treating source actually states
that weight loss results from a specific
digestive disorder, this is sufficient for
our purposes.
We added an explanation of how to
use the weight tables in Listing 5.08,
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when fractions of inches or centimeters
in height measurements must be
converted to specific table values.
We also propose to add a new section,
5.00F2, which describes how we
evaluate chronic liver disease and
resulting impairments, including liver
transplants.
How Are We Proposing to Change the
Criteria in the Listings for Evaluating
Digestive Impairments in Adults?
5.01 Category of Impairments,
Digestive System
Addition of new listing:
We propose to add a new listing, 5.09
Liver Transplant, in keeping with our
other organ transplantation listings, e.g.
heart transplant in listing 4.09 and
kidney transplant in listing 6.02B.
Removal of redundant or reference
listings:
We propose to remove several current
listings because they are redundant.
These four listings are all reference
listings referring to listing 5.08:
• 5.03—Stricture, stenosis, or
obstruction of the esophagus with
weight loss,
• 5.04D—Peptic ulcer disease with
weight loss,
• 5.06E—Chronic ulcerative or
granulomatous colitis with weight loss,
and
• 5.07D—Regional enteritis with
weight loss.
We propose to remove listing 5.05E
because it is a reference listing to 12.02.
We propose to add language to the
preface in 5.00E to refer to the
appropriate body system that may be
affected by a digestive impairment.
We propose to remove several listings
or listing sections because there has
been significant progress in medical
technology and clinical experience
related to the treatment of the digestive
impairments that are contained in the
current listings. Our program experience
is that such advances in treatment mean
that the criteria in some of the current
listings are no longer appropriate
indicators of listing-level severity. Many
of these impairments can be controlled
or resolved and thus are less likely to
result in listing-level severity. Even if
listing-level severity is initially present,
the 12 month statutory duration
requirement may no longer be met.
We propose to remove current listing
5.04, Peptic ulcer disease (demonstrated
by X-ray or endoscopy), due to progress
in evaluation and treatment.
Advances in medical and surgical
management have made many
complications from peptic ulcer disease
such as recurrent ulceration (current
listing 5.04A), fistula formation (current
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listing 5.04B) and recurrent obstruction
(current listing 5.04C) less common.
Treatment often results in significant
improvement so that the criteria in these
listings are no longer an appropriate
indicator of listing-level severity.
Therefore, we propose to remove all
three current peptic ulcer disease
listings.
We also propose to remove several of
the chronic liver disease listings, listing
5.05, due to progress in treatment and
other reasons as described:
• 5.05B—Chronic liver disease with
performance of a shunt operation for
esophageal varices. At the time this
listing was written, only surgical shunts
were available. Surgical shunts involve
extensive abdominal surgery. They were
not usually performed until your
condition became serious enough to
warrant undertaking the risks associated
with prolonged surgery and anesthesia.
Surgical shunts are now performed
much less frequently. Clinical
experience indicates that procedures
such as the transjugular intrahepatic
portal systemic shunt (TIPS), may be
performed with minimal anesthesia and
with fewer complications.
TIPS represents an advance in the
medical management of portal
hypertension and massive ascites.
Indications for a TIPS procedure
include bleeding esophageal varices or
refractory ascites.
• 5.05C—Chronic liver disease with
specific levels of serum bilirubin.
Current listing 5.05C requires only a
persistent elevated bilirubin level. We
propose to delete this listing because a
laboratory finding alone is not an
accurate measure of your ability to
function.
• 5.05F—Chronic liver disease with
liver biopsy. This listing requires
confirmation of chronic liver disease by
a liver biopsy, with a specified clinical
or laboratory finding. We propose to
delete this listing because it does not
necessarily characterize an impairment
of listing-level severity. A liver biopsy,
while confirming the presence of liver
disease, does not correlate with any
specific level of impairment severity or
decrease in functional ability. The
biopsy only confirms what may have
been discovered with imaging and other
laboratory evidence. The specific
laboratory values in the listing also are
not an accurate measure of the severity
and duration of the impairment.
Proposed listing 5.05 will replace many
of the criteria in current 5.05 to reflect
more accurately listing-level
impairments related to chronic liver
disease.
We also propose to remove current
listing 5.06, Chronic ulcerative or
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granulomatous colitis and current
listing 5.07, Regional enteritis for the
following reasons:
• 5.06A—Chronic ulcerative or
granulomatous colitis with recurrent
bloody stools documented on repeated
examinations and anemia manifested by
hematocrit of 30 percent or less.
Anemia, when caused by
inflammatory bowel disease, is not an
appropriate indicator of listing-level
severity. Hematocrit level does not
necessarily correlate with ability to
function. A gradual reduction in
hemoglobin, even to very low levels, is
often well tolerated if you have normal
cardiovascular and pulmonary systems.
• 5.06B and 5.07B—Persistent or
recurrent systemic manifestations, such
as arthritis, iritis, fever or liver
dysfunction due to chronic ulcerative or
granulomatous colitis or regional
enteritis. These listings required only
the presence of a systemic manifestation
in another body system or organ,
without regard to degree of severity of
functional impact. These listings are not
an appropriate indicator of listing-level
severity.
• 5.06C and 5.07C—Intermittent
obstruction due to intractable abscess,
fistula formation or stenosis. Advances
in surgical treatment have improved the
management of these conditions, so that
these listings are no longer an
appropriate indicator of listing-level
severity.
• 5.06D—Recurrence of findings of A,
B, or C after total colectomy. We are
proposing to remove this listing
consistent with our proposal to remove
listings 5.06A, B, and C.
We propose to combine the remainder
of listings 5.06—Chronic ulcerative or
granulomatous colitis, and 5.07—
Regional enteritis, into one listing for
inflammatory bowel disease (IBD)
(proposed listing 5.06). IBD includes
both ulcerative colitis and Crohn’s
disease. Crohn’s disease includes
regional enteritis. Crohn’s disease may
involve the entire gastrointestinal tract,
but usually involves the small intestine
or colon.
We also propose to remove current
listing 5.08B, Weight loss due to any
persisting gastrointestinal disorder, with
weight equal to or less than the values
specified in Table III or IV and one of
the listed abnormal laboratory findings
present on repeated examinations. This
listing allowed a lesser level of weight
loss than that required to meet listing
5.08A when accompanied by one of the
additional listed findings. Those
findings, however, do not correlate with
any specific level of impairment
severity or decrease of functional ability
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that would be an accurate indicator of
listing-level severity.
The following is a detailed
explanation of the proposed listing
criteria.
Proposed Listing 5.02—Recurrent
Gastrointestinal Hemorrhage
We propose to revise the severity
criteria in this listing from anemia with
a hematocrit level of 30 percent or less,
to the requirement for at least 2 units of
blood transfused per episode, with
hemorrhages occurring at least three
times during a consecutive six-month
interval. A hematocrit level is not an
appropriate indicator of the severity of
gastrointestinal hemorrhage. It is the
frequent recurrence of the hemorrhages
and the cumulative effect on you that
results in your inability to perform any
gainful activity. We also propose to
revise the source of gastrointestinal
bleeding covered by this listing from
‘‘upper gastrointestinal hemorrhage
from undetermined cause’’ to
‘‘gastrointestinal hemorrhage from any
cause.’’
Since improvements in medical
treatment may resolve the frequency of
hemorrhages and thus the overall
severity of the impairment, we propose
that you may be considered to be under
a disability for one year following the
last documented hemorrhage.
Thereafter, we will evaluate your
residual impairment(s).
Proposed Listing 5.05—Chronic Liver
Disease
We propose to replace current listing
5.05 with criteria that more accurately
reflect listing-level severity.
We propose to remove ‘‘portal,
postnecrotic, or biliary cirrhosis’’ in the
current listing 5.05 and replace it with
‘‘cirrhosis of any kind.’’ We listed these
kinds of cirrhosis as examples of
chronic liver disease, but we did not
intend that we must specify the kind of
cirrhosis present. Removing the
examples would clarify our intent. We
also propose to remove ‘‘Wilson’s
disease’’ and ‘‘chronic active hepatitis’’
from the examples of chronic liver
disease because hepatic impairment due
to Wilson’s disease and chronic active
hepatitis is included in the revised term
‘‘cirrhosis of any kind.’’
We propose to revise listing 5.05A,
esophageal varices, by defining our
criteria for a massive hemorrhage. By
providing a specific transfusion
requirement, we intend to exclude
minor variceal bleeding which would
not be an indicator of listing-level
severity.
Newer techniques in primary
prevention and treatment of esophageal
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varices, e.g., TIPS, banding, and
sclerotherapy, have significantly
improved the management of varices.
Based on these advances, it is no longer
appropriate to establish disability for 3
years as under current listing 5.05A, so
we propose that you will be considered
under a disability for one year following
the last documented massive
hemorrhage. Thereafter, we will
evaluate your residual impairment(s).
We are proposing to change current
listing 5.05D, ascites due to chronic
liver disease, to 5.05B. We propose to
clarify how the persistence of the ascites
over 6 months must be demonstrated.
We are revising the required time
interval from 5 months of ascites to 6
months of ascites to be consistent with
the other proposed digestive system
listings. In our experience, requiring 6
months of persistent findings enables us
to make a more reliable prediction of
listing-level severity. We also require
that evaluations be done at least two
months apart within the six-month
period to substantiate the chronic nature
of the impairment, and to ensure that
we are evaluating separate episodes.
The presence of sufficient ascitic fluid
requiring frequent paracentesis indicates
disease of listing-level severity. Under
current listing 5.05D, if paracentesis was
not performed, ascites sufficient to be
detected on physical examination, along
with hypoalbuminimia would fulfill
these criteria. However, current imaging
techniques are capable of identifying
even minimal amounts of ascites before
they could be detected on physical
examination, which would not be an
indicator of listing-level severity liver
disease. We explain this in the preface.
If ascites is documented by medically
acceptable imaging rather than by
paracentesis, we still require evidence
to confirm that there is significant
deterioration of liver function.
Therefore, we propose in listing section
5.05B2 to require reduction of serum
albumin to the level specified in the
listing or prolongation of the
prothrombin time as specified in the
listing.
Proposed Listing 5.06—Inflammatory
Bowel Disease
We propose to combine portions of
current listings 5.06 and 5.07 into listing
section 5.06. Ulcerative colitis, Crohn’s
disease, granulomatous colitis, and
regional enteritis are now commonly
referred to as ‘‘Inflammatory bowel
disease’’ (IBD). Combining these listings
is appropriate considering current
medical practice. The listing-level
criteria for IBD concern persistent or
recurrent intestinal obstruction. These
criteria reiterate current listing 5.07A.
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and also clarify that the intestinal
obstruction must be documented by
appropriate medically acceptable
imaging, or operative findings. We
propose the additional requirement that
two episodes of obstruction over a
consecutive 6-month period despite
prescribed therapy be documented in
order to ensure that this is a chronic
impairment that will meet the 12-month
duration requirement, rather than a
single occurrence that can be
successfully treated.
Proposed Listing 5.08—Weight Loss
Due to Any Persisting Gastrointestinal
Disorder
We propose that the weight level
demonstrating listing-level severity be
documented for at least 6 consecutive
months, despite prescribed therapy and
expected to persist at this level for at
least 12 months, in order to ensure the
continuing nature of the impairment.
Weight loss of shorter duration may
respond to treatment, and therefore may
not be expected to persist for 12 months.
Since these listings were originally
written, there have been significant
advances in the treatment of many
digestive disorders, which have resulted
in more favorable prognoses with
treatment. However, it may take up to 6
months to determine whether treatment
will lead to long-term improvement and
possibly recovery, or just result in a
temporary remission of impairment
severity. In light of the current medical
knowledge, we believe that 6 months is
the minimum amount of time needed to
determine that the weight loss due to a
digestive impairment will continue at
listing-level severity for long enough to
fulfill the duration requirement of 12
months. This is consistent with the
changes we propose in the other
digestive listings.
We also propose to update the
weights listed in Tables I and II of
listing 5.08. While we are proposing to
adopt the use of Body Mass Index (BMI)
in evaluating malnutrition in children
(listing 105.08), we are not, at this time,
proposing to adopt BMI to evaluate
weight loss in adults. The Centers for
Disease Control and Prevention (CDC)
state that BMI is used differently with
children than it is with adults. ‘‘* * *
Body Mass Index, or BMI (wt/ht2)
provides a guideline based on weight
and height to determine underweight
and overweight. As children grow, their
body fatness changes over the years. The
interpretation of BMI depends on the
child’s age. Additionally, girls and boys
differ in their body fatness as they
mature. Therefore, we plot the BMI-forage according to sex-specific charts.’’
The CDC has prepared charts and tables
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that calculate BMI values for selected
heights and weights for you from ages
2 to 20 years. The CDC has further
determined that a BMI-for-age <5th
percentile meets their criteria for
underweight. The CDC does not
calculate a figure nor indicate a cutoff
that is judged to be indicative of
malnutrition.
The current listings are based on
standard growth charts to satisfy the
listing for malnutrition. Current listing
105.08 requires (in part): ‘‘Malnutrition,
due to a demonstrable gastrointestinal
disease causing either a fall of 15
percentiles of weight which persists or
the persistence of weight which is less
than the third percentile (on standard
growth charts).
The 3rd percentile is generally
accepted as the lower limit of the
normal range for most biologic
measurements. Persistence below this
level would warrant evaluation and, if
available, intervention. Since the new
BMI-for-age charts continue to provide
percentiles, we are able to continue our
policy of measurements below the 3rd
percentile determined to correspond
with listing-level severity for children.
In assessing weight loss in adults, we
have never used percentiles based on
age calculations. Our current listing 5.08
is based on the Metropolitan Life
Insurance Company’s weight chart for
medium frame individuals. The weights
in tables 1 and 2 of listing 5.08 represent
a 20% reduction in the beginning
weight for medium frame individuals as
reflected in the weight charts in effect
at the time the listings were last revised.
The CDC has no such BMI-for-age
charts for adults. They do state that
‘‘underweight’’ in adults is indicated by
a BMI less than 18.5; however, neither
the CDC nor any other recognized
authority known to us has determined a
BMI for adults that would be consistent
with listing-level severity weight loss
due to a gastrointestinal impairment.
Until we have a scientific basis for
changing the way we calculate listinglevel severity weight loss in adults, we
determined it would be best to just
update our tables 1 and 2 using the
latest Metropolitan Life Insurance
Company’s weight chart, last updated in
1983.
We also expanded the heights and
weights in the tables to add the metric
equivalents for assistance in
adjudication.
The weight loss tables in listing 5.08
include listing-level weights for men
whose height is between 5 feet 1 inch
and 6 feet 4 inches, and for women
whose height is between 4 feet 10
inches and 6 feet 1 inch. If your height
is outside these table values and you
allege disability due to weight loss
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related to a digestive impairment, these
tables cannot be applied to evaluate
whether your impairment meets the
listing. In this situation, we would
review the evidence in file to determine
if your condition medically equals the
listing. Considering the table weights
and your weight, we would make a
severity judgment. If you have a severe
impairment that does not meet nor
equal the listings, we continue to
evaluate your claim through the
sequential evaluation process, which
would require assessment of your
residual functional capacity and, if
necessary, consideration of vocational
factors such as your age, education and
past work experience.
Proposed Listing 5.09—Liver
Transplant
We propose that you should be
considered under a disability for 12
months following the surgery, due to the
nature and course of recovery for this
procedure. After that time, we will
evaluate the residual impairment(s).
This is consistent with our criteria for
assessing other organ transplants, such
as kidney and heart.
How Are We Proposing To Change the
Preface To the Listings for Evaluating
Digestive Impairments in Children?
105.00
Digestive System
As we already discussed in the
explanation of 5.00 in the adult rules,
we propose to revise the preface to
provide additional guidance for
adjudicating digestive impairments.
Where necessary, we added information
specific to the childhood listings;
however, we repeated much of the
proposed preface 5.00 in the proposed
preface 105.00. This is because the same
basic rules for establishing and
evaluating the existence and severity of
digestive impairments in adults also
apply to children.
Proposed 105.00A through 105.00F
correspond to proposed 5.00A through
5.00F in the adult rules. Because we
already described these provisions
under the explanation of proposed 5.00,
the following discussions describe only
those provisions that are unique to the
childhood rules or that require further
explanation.
Proposed 105.00A—What Kind of
Impairments Do We Consider in the
Digestive System?
This section contains the information
in current 105.00A, and information
from the last sentence in current
105.00C. It differs from the
corresponding 5.00A in the proposed
adult rules in the following ways:
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• We added a paragraph addressing
congenital defects of the gastrointestinal
organs; and
• We added ‘‘growth and
development’’ to ‘‘nutrition’’, in the
paragraph addressing surgical
diversions of the intestinal tract, since
these factors are relevant to the
assessment of disability in children.
Proposed 105.00B—What
Documentation Do We Need?
This section contains the information
in current 105.00B. We made editorial
changes to refer to ‘‘children’’ rather
than ‘‘individuals’’ and changes to
reflect the sequential evaluation of
disability for children. Aside from these
changes, the only substantive difference
between this section and the
corresponding proposed section for
adults is the addition of ‘‘assessment(s)
of growth and development’’ to the list
of types of evidence that we consider.
Proposed 105.00C—How Do We
Evaluate Digestive Disorders Under
Listings That Require Recurring or
Persistent Findings?
This is a new section. It differs from
the corresponding proposed 5.00C in
the adult rules, only in that it references
childhood listings 105.05, 105.06, and
105.08, rather than adult listings.
Proposed 105.00D—How Do We
Consider the Effects of Treatment?
This is a new section that corresponds
to the proposed adult section 5.00D.
Proposed 105.00E—How Do We
Evaluate Impairments That Do Not
Meet One of the Digestive Listings?
This is a new section. It contains two
subsections that do not appear in the
proposed adult rules. Subsection
105.00E1b includes the information in
current 105.00D about multiple
anomalies and subsection 105.00E1c
contains an updated version of the
information in the first two sentences of
current 105.00C about digestive
impairments and reduction in the rate of
growth.
We also explain how evaluation of
your impairment(s) will continue
through the sequential evaluation
process. We added a sentence about
functionally equaling the listings, with
a cross-reference to the appropriate
regulatory citation.
Proposed 105.00F—What Are Our
Guidelines for Evaluating Specific
Digestive Impairments?
This section contains the information
in the first two sentences of current
105.00C. The rest of the information in
this section is new. It is divided into
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four subsections: Malnutrition, weight
loss and growth retardation; Chronic
liver disease; Esophageal stricture or
stenosis; and Inflammatory bowel
disease.
In subsection 105.00F1a, we explain
how to evaluate weight loss and growth
retardation that result from
malnutrition. We also list examples of
laboratory findings that represent
chronic nutritional deficiency. In the
revised listing 105.08, we require a
documented sign of chronic nutritional
deficiency to confirm the existence of a
gastrointestinal disease resulting in
malnutrition. We do not include these
specific findings in the listing language
because the required laboratory
finding(s) are not limited to one of these
specific examples. We will also accept
other medically acceptable laboratory
findings that represent chronic
nutritional deficiency.
Since we also are proposing to revise
listing 105.08 by using Body Mass Index
(BMI) measurements, we added a
discussion of these measurements in
subsection 105.00F1b.
The Centers for Disease Control and
Prevention (CDC) state that BMI is used
differently with children than it is with
adults. ‘‘* * * Body Mass Index, or BMI
(wt/ht2) provides a guideline based on
weight and height to determine
underweight and overweight. As
children grow, their body fatness
changes over the years. The
interpretation of BMI depends on the
child’s age. Additionally, girls and boys
differ in their body fatness as they
mature. Therefore, we plot the BMI-forage according to sex-specific charts.’’
The CDC has prepared charts and tables
that calculate BMI values for selected
heights and weights for you from ages
2 to 20 years. The CDC has further
determined that a BMI-for-age <5th
percentile meets their criteria for
underweight. The CDC does not
calculate a figure nor indicate a cutoff
that is judged to be indicative of
malnutrition.
The current listings are based on
standard growth charts to satisfy the
listing for malnutrition. Current listing
105.08 requires (in part): ‘‘Malnutrition,
due to a demonstrable gastrointestinal
disease causing either a fall of 15
percentiles of weight which persists or
the persistence of weight which is less
than the third percentile (on standard
growth charts).
The 3rd percentile is generally
accepted as the lower limit of the
normal range for most biologic
measurements. Persistence below this
level would warrant evaluation and, if
available, intervention. Since the new
BMI-for-age charts continue to provide
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percentiles, we are able to continue our
policy of measurements below the 3rd
percentile determined to correspond
with listing-level severity for children.
The new subsection on chronic liver
disease, section 105.00F2, corresponds
to the information in the proposed adult
rules, except that we also added a
discussion on portal hypertension in
proposed 105.00F2C because chronic
liver disease in children often presents
as complications of portal hypertension.
Section 105.00F3 addresses
esophageal stricture or stenosis. This
new preface section gives guidance in
adjudicating this impairment when the
malnutrition listing is not met.
Section 105.00F4 discusses the
documentation of an intractable
perineal or intra-abdominal
complication, such as intractable fecal
incontinence.
How Are We Proposing To Change the
Criteria in the Listings for Evaluating
Digestive Impairments in Children?
105.00 Category of Impairments,
Digestive System
Addition of new listing:
As in the proposed adult rules, we
propose to add a new listing for
children to address liver
transplantation. The new listing will be
105.09, liver transplant.
Removal of redundant or reference
listings:
We propose to remove these listings
because they refer to listing 105.08:
• 105.03—Esophageal obstruction,
caused by atresia, stricture or stenosis,
and
• 105.07B—Chronic inflammatory
bowel disease with malnutrition.
These listings are met only when
listing 105.08—Malnutrition, due to
demonstrable gastrointestinal disease, is
met. As we noted above, we are
proposing to remove reference listings
because they are redundant.
We also propose to remove these
other reference listings:
• 105.05E—Chronic liver disease
with hepatic encephalopathy. This
reference listing directs us to evaluate
the impairment under the criteria in
112.02—Organic mental disorders.
Hepatic encephalopathy is addressed in
proposed section 105.00E1a of the
preface, which states that the
impairment should be assessed under
the criteria for the appropriate mental
disorder or neurological listing.
• 105.07C—Chronic inflammatory
bowel disease, with growth impairment
as described under the criteria in
100.03. This listing refers us to the
criteria in listing 100.03—Growth
impairment. We propose to add material
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to the preface in 105.00E1c and
105.00F1a to address assessment of
these impairment manifestations.
As in the proposed adult rules, we
propose to remove several listings or
listing sections since there has been
significant progress in medical
technology and clinical experience
related to the treatment of digestive
impairments. Our program experience
shows that because of these advances
the criteria in some of the current
listings can no longer be considered to
result in marked and severe functional
limitations. Even if listing-level severity
is initially present, the statutory
duration requirement may no longer be
met.
We propose to remove the following
chronic liver disease listings:
• 105.05A.—Chronic liver disease
with inoperable biliary atresia. Children
with this impairment often receive
transplants and they would be evaluated
under the proposed new listing
105.09—liver transplant. Otherwise,
manifestations of this disease would be
evaluated under the other liver disease
listings.
• 105.05D.—Chronic liver disease
with hepatic coma. Hepatic coma, like
hepatic encephalopathy, will now be
assessed under the criteria for the
appropriate mental or neurological
listings.
• 105.05F.—Chronic liver disease
with chronic active inflammation or
necrosis documented by SGOT
persistently more than 100 units or
serum bilirubin of 2.5 mg. percent or
greater. We propose to remove this
listing because it requires only a
persistent laboratory finding. Based on
our program experience, a laboratory
finding alone is not an accurate measure
of the severity or duration of the
impairment.
The following is a detailed
explanation of the proposed listing
criteria.
Proposed Listing 105.05—Chronic Liver
Disease
We propose to add ‘‘cirrhosis of any
kind,’’ for consistency with the
proposed adult rules.
We propose to revise current listing
105.05C.—Chronic liver disease with
esophageal varices, and renumber it as
proposed listing 105.05A. We have
added the requirement for bleeding
attributable to the varices because the
mere presence of esophageal varices, by
itself, does not necessarily result in
marked and severe functional
limitations. As in the proposed adult
listings, we have provided a specific
transfusion requirement to exclude
minor variceal bleeding which is not an
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indicator of listing-level severity. The
transfusion requirement for children is
based on frequency of needed
transfusions, rather than amount of
blood transfused, because in children,
blood transfusions are only
administered in cases of extreme need
and the amount of blood transfused is
variable depending on body size.
We propose to revise current listing
105.05B—Chronic liver disease with
intractable ascites, by removing the
albumin level requirement. Persistent
ascites related to chronic liver disease is
an impairment of listing-level severity
in children, regardless of serum albumin
level.
As explained in the preamble
concerning the comparable adult listing,
the presence of sufficient ascitic fluid
requiring frequent paracentesis indicates
disease of listing-level severity.
However, current imaging techniques
are capable of identifying even minimal
amounts of ascites before they could be
detected on physical examination,
which would not be an indicator of
listing-level severity liver disease; thus,
in the absence of paracentesis, we
require ascites to be documented on
physical examination and by medically
appropriate imaging techniques. We
explain this in the preface.
Proposed Listing 105.06—Inflammatory
Bowel Disease
We propose to renumber current
listing 105.07—Chronic inflammatory
bowel disease, to proposed listing
105.06, for consistency with the
corresponding proposed adult listing.
We are revising and clarifying current
105.07A—Chronic inflammatory bowel
disease with intestinal manifestations or
complications, which becomes the only
listing under proposed 105.06. We
added the requirements for persistent or
recurrent findings to ensure a frequency
or duration of impairment consistent
with listing-level severity. We also now
require appropriate medically
acceptable imaging evidence of the
impairment. We are also adding a
requirement for functionally limiting
signs and symptoms that are
characteristic of the impairment. Since
inflammatory bowel disease can affect
the entire digestive tract, we added an
alternate subsection for perineal or
intra-abdominal complications.
Proposed Listing 105.08—Malnutrition
We propose to revise this section to be
consistent with the new weight-forlength and Body Mass Index (BMI)
measurements, growth charts and data
file tables from the Centers for Disease
Control and Prevention (CDC). On May
30, 2000, the CDC updated their 1977
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weight-for-length growth charts, and
introduced BMI-for-age charts and
tables. The CDC explains: ‘‘* * * (BMI)
is used to judge whether an individual’s
weight is appropriate for their height.
* * * The new BMI growth charts can
be used clinically beginning at 2 years
of age, when an accurate stature can be
obtained. These BMI-for-age charts were
created for use in place of the 1977
weight-for-stature charts, as they are
considered a more accurate tool.’’
(NHANES (National Health & Nutrition
Examination Survey) CDC Growth
Charts: United States, The Revised
Growth Charts, May 30, 2000. Both the
weight-for-length and BMI-for-age charts
and tables are available at http://
www.cdc.gov/nchs/about/major/
nhanes/growthcharts/background.htm.)
We will prepare a Social Security
Ruling containing instructions
consistent with the CDC’s BMI
guidelines. It will be issued concurrent
with publication of this material as a
final rule.
In children, the CDC defines
‘‘Underweight’’ as a BMI-for-age <5th
percentile. However, neither the CDC
nor any other recognized expert
authority has published guidelines for
the classification of malnutrition based
on BMI. We will continue to investigate
this area. In the meantime, we propose
to continue to use our current criteria of
persistence of weight for length or
height below the third percentile to
meet listing-level severity for
malnutrition.
Proposed Listing 105.09—Liver
Transplant. We propose to add this new
listing for children, consistent with the
addition of listing 5.09—Liver
transplant in the proposed adult rules.
We propose that you should be
considered under a disability for 12
months following the surgery, due to the
nature and course of recovery for this
procedure. After that time, we will
evaluate the residual impairment(s).
This is consistent with our criteria for
assessing other organ transplants, such
as kidney transplant in listing 106.02D
and heart transplant in listing 104.09.
Clarity of These Proposed Rules
Executive Order 12866 requires each
agency to write all rules in plain
language. In addition to your
substantive comments on these
proposed rules, we invite your
comments on how to make these
proposed rules easier to understand.
For example:
• Have we organized the material to
suit your needs?
• Are the requirements in the rules
clearly stated?
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• Do the rules contain technical
language or jargon that isn’t clear?
• Would a different format (grouping
and order of sections, use of headings,
paragraphing) make the rules easier to
understand?
• Would more (but shorter) sections
be better?
• Could we improve clarity by adding
tables, lists, or diagrams?
• What else could we do to make the
rules easier to understand?
Regulatory Procedures
Executive Order (E.O.) 12866
We have consulted with the Office of
Management and Budget (OMB) and
determined that these proposed rules
meet the criteria for an economically
significant regulatory action under E.O.
12866. They are also a ‘‘major’’ rule
under 5 U.S.C. 801ff. The following is
a discussion of the potential costs and
benefits of this regulatory action. This
assessment also contains an analysis of
alternatives we considered and chose
not to adopt.
These proposed rules benefit society
by updating the current listings to
provide criteria that reflect state-of-theart medical science and technology. The
proposed rules ensure that
determinations of disability have a
sound medical basis, that claimants
receive equal treatment through the use
of specific criteria, and that people who
are disabled can be readily identified
and awarded benefits if all other factors
of entitlement or eligibility are met.
We are projecting savings in program
expenditures as a result of these actions,
described in more detail below.
to the SSI program ($85 million in a 5year period beginning in FY 2003).
Fiscal year:
2003 ......................................
2004 ......................................
2005 ......................................
2006 ......................................
2007 ......................................
¥$2.5
¥$10
¥$20
¥$25
¥$30
Total ..............................
2 ¥$85
Program Costs
We2 do not expect any program costs
to result from these proposed
regulations.
Administrative Savings
We do not expect any administrative
savings to result from these proposed
regulations.
Administrative Costs
We expect that, if finalized, there will
be some administrative costs associated
with these proposed rules. If finalized,
the proposed rules are expected to result
in administrative costs less than 25
work years and less than $2 million per
year.
Policy Alternatives
We considered, but did not select, the
following policy alternative:
Keep the current criteria with no or only
minor technical changes
We considered not revising the
listings, or making only minor technical
changes and thus, continuing to use our
current criteria. However, we believe
that proposing these revisions is
preferable because of the medical
advances that have been made in
treating and evaluating these types of
impairments. The current listings are
now over 15 years old. Medical
Program Savings
advances in disability evaluation and
1. Title II
treatment and our program experience
make clear that the current listings do
We estimate that, if finalized, these
not reflect state-of-the-art medical
proposed rules would result in reduced
knowledge and technology.
program outlays resulting in the
Since there would be no changes or
following savings (in millions of dollars)
to the title II program ($295 million total only minor technical changes in using
this alternative, the program and
in a 5-year period beginning in FY
administrative costs would be the same
2003).
as under the current rules. However, the
Fiscal year:
2003 ......................................
¥$5 program savings associated with the
2004 ......................................
¥$35 proposed rules would not be achieved.
2005 ......................................
2006 ......................................
2007 ......................................
¥$60
¥$85
¥$110
Total ..............................
1 ¥$295
2. Title XVI
We 1 estimate that, if finalized, these
proposed rules will result in reduced
program outlays resulting in the
following savings (in millions of dollars)
1 5-year
total may not be equal to the sum of the
annual totals due to rounding-out.
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Regulatory Flexibility Act
We certify that these proposed rules
would not have a significant economic
impact on a substantial number of small
entities because they would affect only
individuals. Thus, a regulatory
flexibility analysis as provided in the
Regulatory Flexibility Act, as amended,
is not required.
2 Federal SSI payments due on October 1st in
fiscal years 2006 and 2007 are included with
payments for the prior fiscal year.
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57017
Paperwork Reduction Act
These proposed rules contain
reporting requirements at 5.00B, 5.00D,
105.00B, and 105.00D. The public
reporting burden is accounted for in the
Information Collection Requests for the
various forms that the public uses to
submit the information to SSA.
Consequently, a 1-hour placeholder
burden is being assigned to the specific
reporting requirement(s) contained in
these rules. We are seeking clearance of
the burdens referenced in these rules
because they were not considered
during the clearance of the forms. An
Information Collection Request has been
submitted to OMB. We are soliciting
comments on the burden estimate; the
need for the information; its practical
utility; ways to enhance its quality,
utility and clarity; and on ways to
minimize the burden on respondents,
including the use of automated
collection techniques or other forms of
information technology. Comments
should be submitted to the Social
Security Administration at the following
address: Social Security Administration,
Attn: SSA Reports Clearance Officer,
Rm. 1–A–20 Operations Building, 6401
Security Boulevard, Baltimore, MD
21235–6401. Comments can be received
for between 30 and 60 days after
publication of this notice. Comments
will be most useful if received by SSA
within 30 days of publication.
(Catalog of Federal Domestic Assistance
Program Nos. 96.001, Social SecurityDisability Insurance; 96.002, Social SecurityRetirement Insurance; 96.004, Social
Security-Survivors Insurance; and 96.006,
Supplemental Security Income)
List of Subjects in 20 CFR Part 404
Administrative practice and
procedure, Blind, Disability benefits,
Old-Age, Survivors, and Disability
Insurance, Reporting and recordkeeping
requirements, Social Security.
Dated: November 5, 2001.
Larry G. Massanari,
Acting Commissioner of Social Security.
For the reasons set forth in the
preamble, we propose to amend chapter
III of title 20 of the Code of Federal
Regulations as set forth below:
PART 404—FEDERAL OLD-AGE,
SURVIVORS AND DISABILITY
INSURANCE (1950–
)
1. The authority citation for subpart P
of part 404, continues to read as follows:
Authority: Secs. 202, 205(a), (b), and (d)–
(h), 216(i), 221(a) and (i), 222(c), 223, 225,
and 702(a)(5) of the Social Security Act (42
U.S.C. 402, 405(a), (b), and (d)–(h), 416(i),
421(a) and (i), 422(c), 423, 425, and
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Federal Register / Vol. 66, No. 220 / Wednesday, November 14, 2001 / Proposed Rules
902(a)(5)); sec. 211(b), Pub. L. 104–193, 110
Stat. 2105, 2189.
2. Item 6 of the introductory text
before part A of appendix 1 is amended
by revising the expiration date, as
follows:
Appendix 1 to Subpart P of Part 404—
Listing of Impairments
*
*
*
*
*
6. Digestive System (5.00 and 105.00):
[Insert date of publication of the final rules
in the Federal Register.]
*
*
*
*
*
3. Section 5.00 in part A and section
105.00 in part B of appendix 1 are revised to
read as follows:
*
*
*
*
*
5.00 Digestive System
A. What Kind of Impairments Do We
Consider in the Digestive System?
1. Impairments of the digestive system
include malnutrition, inflammatory bowel
disease, hemorrhage, esophageal dysfunction,
and hepatic (liver) dysfunction.
2. Digestive disorders may also lead to
complications (e.g., obstruction) or be
accompanied by systemic manifestations in
other body systems.
3. Surgical diversion of the intestinal tract
such as colostomy and ileostomy does not
usually result in an inability to perform any
gainful activity, as long as you are able to
maintain adequate nutrition.
4. Gastrointestinal impairments frequently
respond to medical or surgical treatment and,
therefore, the severity of these disorders
should generally be considered within the
context of prescribed treatment. This may be
necessary in determining whether the
duration requirement for disability will be
met for cases in which you have not
otherwise satisfied the duration requirement.
B. What Documentation Do We Need?
1. When we assess gastrointestinal or liver
impairments, we usually need longitudinal
evidence covering a period of at least 6
months of observations and treatment, unless
we can make a fully favorable determination
or decision without it. The evidence should
include all available clinical and laboratory
findings, including appropriate medically
acceptable imaging studies, endoscopy,
operative, and pathology reports. Criteria for
documentation will be found in the
individual listings.
3. You may not have received ongoing
treatment or have an ongoing relationship
with the medical community, despite the
existence of a severe impairment(s). We
evaluate such cases on the basis of the
objective medical evidence and other
available evidence, taking into consideration
all relevant factors including your medical
history, symptoms, and medical source
statements. Even though you may not be able
to show an impairment that meets the criteria
of one of the digestive listings, you may have
an impairment(s) that medically equals the
listings or may be found disabled based on
consideration of your residual functional
capacity (RFC) and age, education, and work
experience.
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C. How Do We Evaluate Digestive Disorders
Under Listings That Require Recurring or
Persistent Findings?
1. Listings 5.02, 5.05, 5.06 and 5.08 require
specific findings to be present on a recurring
or persisting basis. Recurring means the
longitudinal clinical record shows that the
finding(s) satisfies the criteria in the listing
as specified and that pattern has lasted or is
expected to last for a continuous period of at
least 12 months. Persisting means the
longitudinal clinical record shows that, with
few exceptions, the finding(s) has been at, or
is expected to be at, the level specified in the
listing for a continuous period of at least 12
months.
2. Events necessary to meet the listing (e.g.,
3 events within a consecutive 6 month
period) must occur within the period we are
considering in connection with an
application or continuing disability review.
In every listing in which we require more
than one event, there must be at least 1
month between the events (unless otherwise
specified), to ensure that we are evaluating
separate episodes.
D. How Do We Consider the Effects of
Treatment?
1. We assess the effect of treatment by
determining if there is improvement in the
signs, symptoms, and laboratory findings of
the disorder, and if there are side effects that
may result in functional limitations. We
assess the effects of medication, therapy,
surgery, or any other form of treatment you
receive, when determining the severity and
the duration of the impairment(s). The
medical evidence should include:
(a) a description of the treatment
prescribed (e.g., the type of medication or
therapy, the use of total parenteral nutrition
(TPN) or enteral nutrition);
(b) dosage, method, and frequency of
administration;
(c) your response to the treatment;
(d) any adverse effects of such treatment;
(e) the expected duration of the treatment.
2. Because treatment itself or the effects of
treatment may be temporary, in most cases
sufficient time must elapse to allow us to
evaluate the impact and expected duration of
treatment and side effects. Where adverse
effects of treatment contribute to the
impairment severity, the duration or
expected duration of the treatment must be
considered in assessing the duration of the
impairment(s).
3. Nutritional therapy. The requirement for
aggressive nutritional therapy, including
parenteral or specialized enteral nutrition to
avoid debilitating complications of a disease
does not, in and of itself, indicate an inability
to perform gainful activity, but should be
considered, as any other treatment, in
evaluation of the overall severity of the
impairment.
E. How do we evaluate impairments that do
not meet one of the digestive listings?
1. These listings are only examples of
common digestive impairments that we
consider severe enough to prevent you from
doing any gainful activity. If your
impairment(s) does not meet the criteria of
any of these listings, we must also consider
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whether you have an impairment(s) that
satisfies the criteria of a listing in another
body system. For example, when liver
disease results in hepatic encephalopathy,
we should evaluate the impairment(s) under
the criteria for the appropriate mental
disorder or neurological listing(s).
2. If you have a medically determinable
impairment(s) that does not meet a listing,
we will determine whether your
impairment(s) medically equals the listings.
(See§§ 404.1526 and 416.926.) If your
impairment(s) does not meet or medically
equal the listings, you may or may not have
the RFC to engage in substantial gainful
activity. In that situation, we proceed to the
fourth, and if necessary, the fifth steps of the
sequential evaluation process in §§ 404.1520
and 416.920. When we decide whether you
continue to be disabled, we use the rules in
§§ 404.1594 and 416.994, as appropriate.
F. What are our guidelines for evaluating
specific digestive impairments?
1. Malnutrition and weight loss.
Gastrointestinal disease may result in
malnutrition and weight loss. In addition to
the impairments specifically mentioned in
the listings, other gastrointestinal disorders
such as stricture, stenosis or obstruction of
the esophagus may result in significant
weight loss. The resulting weight loss should
be evaluated under the criteria of 5.08. When
using the tables in 5.08:
(a) If the reported height measured in
inches falls between the whole number
values, the height should be rounded off to
the nearest inch by whole number (e.g., if
height is given as 621⁄4 inches, round off to
62 inches). If the fraction is precisely onehalf inch, the height should be rounded up
to the nearest whole number (e.g., if height
is given as 621⁄2 inches, round up to 63
inches).
(b) If the reported height measured in
centimeters falls evenly between two table
values (e.g., 151 cm falls evenly between 150
cm and 152 cm), the height should be
rounded up to the nearest table value (e.g.,
152 cm).
(c) If the reported height measured in
centimeters falls between two table values
(e.g., 148 cm is between 147 cm and 150 cm),
the height should be rounded off to the
nearest table value (e.g., 147 cm).
2. Chronic liver disease is liver cell
necrosis, inflammation, or scarring from any
cause, that persists for more than 6 months,
and is expected to continue for at least 12
months. Clinical manifestations may vary
from an asymptomatic state to incapacitation
due to liver failure. Acute hepatic injury is
frequently reversible, as in viral, drug
induced, and alcoholic hepatitis, and hepatic
ischemia. In the absence of continuing
evidence of a chronic impairment, episodes
of acute liver disease do not necessarily meet
the requirement for chronic liver disease.
(a) Signs, and symptoms of chronic liver
disease often include: jaundice (yellow
appearance of the skin and mucous
membranes), intractable pruritis (itching),
ascites (accumulation of fluid in the
abdominal cavity), lower extremity edema
(swelling due to large amounts of fluid),
gastrointestinal bleeding, fatigue, nausea,
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change in mental status and loss of appetite.
Laboratory findings in cases involving liver
disease may include abnormalities of liver
enzymes, decreased serum albumin,
increased bilirubin, abnormal coagulation
studies, and abnormal liver biopsy.
(b) Liver disease may result in portal
hypertension and esophageal varices,
massive variceal hemorrhage, ascites, hepatic
encephalopathy, and/or liver transplantation.
We should assess impairment due to hepatic
encephalopathy under the criteria for the
appropriate mental disorder or neurological
listing(s).
(c) Massive hemorrhage from esophageal
varices typically involves hematemesis
(vomiting of blood), melena (passage of dark
stools), or hematochezia (passage of bloody
stools). You may be hemodynamically
unstable as shown by signs and symptoms
such as pallor (paleness), diaphoresis
(profuse perspiration), postural hypotension
(fall in blood pressure when standing), and
syncope (fainting). The situation can be
considered life-threatening with urgent need
for multiple transfusions and other
supportive care.
(d) Liver function tests such as serum
bilirubin or enzyme levels may correlate
poorly with the clinical severity of liver
disease, and must not be relied upon in
isolation. Ascites, when associated with
either albumin depletion or prolongation of
the prothrombin time, usually indicates
severe loss of liver function. Minimal ascites,
as might be detected only by imaging
techniques and not on physical examination,
is not sufficient to meet the criteria in listing
5.05B.
(e) Liver transplantation may be performed
for progressive liver failure, life-threatening
complications of liver disease, tumor or
trauma. Disability is considered to last for
one year from the date of transplant. After
that time, we will evaluate the residual
impairment(s), as outlined in paragraph (g)
below.
(f) When we use the phrase ‘‘[c]onsider
under a disability for 1 year following’’ a
specific event, we are making a statement
about the expected duration of disability, not
about the onset of disability. We do not
restrict the determination of the onset of
disability to the date of the specified event.
We can establish an earlier onset date if you
are not engaging in substantial gainful
activity (SGA) and the evidence in file
supports the earlier onset date of disability.
(g) After the one-year period following
transplantation, we evaluate the effects of
any residual impairment(s). Functional
improvement after liver transplant depends
upon various factors, including adequacy of
post-transplant liver function, incidence and
severity of infection, occurrence of rejection
crisis(es), the presence of systemic
complications and the side effects of
immuno-suppressive agents.
5.01 Category of Impairments, Digestive
System
5.02 Recurrent gastrointestinal
hemorrhage from any cause, requiring at least
two units of blood transfused per episode,
and occurring at least three times during a
consecutive 6-month period. (All incidents
within a consecutive 14-day period
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constitute one episode.) Consider under a
disability for 1 year following the last
documented hemorrhage; thereafter, evaluate
the residual impairment(s).
5.05 Chronic liver disease and cirrhosis of
any kind, WITH:
A. Esophageal varices demonstrated by xray, endoscopy, or other appropriate
medically acceptable imaging, with massive
hemorrhage attributed to varices which
requires a transfusion of at least 5 units of
blood in 48 hours. Consider under a
disability for 1 year following the last
documented massive hemorrhage; thereafter,
evaluate the residual impairment(s); OR
B. Ascites persisting over a consecutive 6month period despite prescribed treatment.
The following findings must be demonstrated
on at least two evaluations occurring at least
2 months apart within the 6-month period:
1. Ascites documented by paracentesis; OR
2. Ascites documented on physical
examination and by appropriate medically
acceptable imaging with:
(a) an associated serum albumin of 3.0 gm/
dl or less, or;
(b) prolongation of the prothrombin time of
at least 2 seconds over the control.
5.06 Inflammatory bowel disease (e.g.,
ulcerative colitis, Crohn’s disease) as
documented by endoscopy, biopsy,
appropriate medically acceptable imaging, or
operative findings, with persistent or
recurrent intestinal obstruction over a
consecutive 6-month period, despite
prescribed treatment, WITH:
A. Confirmation, by appropriate medically
acceptable imaging, of stenotic areas in small
intestine or colon with proximal dilatation,
and;
B. Documentation of at least two episodes
of abdominal pain, distention, and vomiting.
5.08 Weight loss due to any persisting
gastrointestinal disorder, with weight equal
to or less than the values specified in Table
I or II, persistent for at least 6 consecutive
months despite prescribed treatment, and
expected to persist at this level for at least
12 consecutive months.
TABLE I.—MEN
Height
Weight
Inches/centimeters
Pounds/kilograms
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
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in./155
in./158
in./160
in./163
in./165
in./168
in./170
in./173
in./175
in./178
in./180
in./183
in./185
in./188
in./191
in./193
cm
cm
cm
cm
cm
cm
cm
cm
cm
cm
cm
cm
cm
cm
cm
cm
Frm 00019
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
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103
105
106
108
110
111
114
116
118
121
123
126
128
131
134
137
lbs/47
lbs/48
lbs/48
lbs/49
lbs/50
lbs/51
lbs/52
lbs/53
lbs/54
lbs/55
lbs/56
lbs/57
lbs/58
lbs/60
lbs/61
lbs/62
Sfmt 4702
kg
kg
kg
kg
kg
kg
kg
kg
kg
kg
kg
kg
kg
kg
kg
kg
TABLE II.—WOMEN
Height
Weight
Inches/centimeters
Pounds/kilograms
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
in./147
in./150
in./152
in./155
in./158
in./160
in./163
in./165
in./168
in./170
in./173
in./175
in./178
in./180
in./183
in./185
cm
cm
cm
cm
cm
cm
cm
cm
cm
cm
cm
cm
cm
cm
cm
cm
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
87 lbs/40 kg
89 lbs/40 kg
90 lbs/41 kg
92 lbs/42 kg
94 lbs/43 kg
97 lbs/44 kg
99 lbs/45 kg
102 lbs/46 kg
104 lbs/47 kg
106 lbs/48 kg
109 lbs/49 kg
111 lbs/50 kg
114 lbs/52 kg
116 lbs/53 kg
118 lbs/54 kg
121 lbs/55 kg
5.09 Liver transplant. Consider under a
disability for 1 year following surgery.
Thereafter, evaluate the residual impairment
(see 5.00F2e.)
*
*
*
*
*
*
*
*
Part B
*
*
105.00
DIGESTIVE SYSTEM
A. What kind of impairments do we consider
in the digestive system?
1. Impairments of the digestive system
include malnutrition, inflammatory bowel
disease, hemorrhage, esophageal dysfunction,
and hepatic (liver) dysfunction.
2. Digestive disorders may also lead to
complications (e.g., obstruction) or be
accompanied by systemic manifestations in
other body systems.
3. Congenital defects involving the organs
of the gastrointestinal system may result in
your inability to maintain adequate nutrition,
growth and development.
4. Surgical diversion of the intestinal tract
such as colostomy and ileostomy does not
usually result in marked and severe
functional limitations, as long as you are able
to maintain adequate nutrition, growth and
development.
5. Gastrointestinal impairments frequently
respond to medical or surgical treatment,
and, therefore, the severity of these disorders
should generally be considered within the
context of prescribed treatment. This may be
necessary in determining whether the
duration requirement for disability will be
met for cases in which you have not already
otherwise satisfied the duration requirement.
B. What documentation do we need?
1. When we assess gastrointestinal or liver
impairments, we usually need longitudinal
evidence covering a period of at least 6
months of observations and treatment, unless
we can make a fully favorable determination
or decision without it. The evidence should
include all available clinical findings,
including assessment(s) of growth and
development, as well as all laboratory
findings, including operative, appropriate
medically acceptable imaging studies,
endoscopy, and pathology reports. Criteria
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for documentation will be found in the
individual listings.
2. You may not have received ongoing
treatment or have an ongoing relationship
with the medical community, despite the
existence of a severe impairment(s). We
evaluate such cases on the basis of the
objective medical evidence and other
available evidence, taking into consideration
all relevant factors (see §§ 416.924, 416.924a,
and 416.924b) including your medical
history, symptoms, and medical source
statements. Even though you may not be able
to show an impairment that meets the criteria
of one of the digestive listings, you may have
an impairment(s) medically equivalent in
severity to one of the listed impairments or,
as appropriate, may be disabled based on
functionally equaling the listings (See
§§ 404.1526, 416.926, and 416.926a.).
C. How do we evaluate digestive disorders
under listings that require recurring or
persistent findings?
1. Listings 105.05, 105.06 and 105.08
require specific findings to be present on a
recurring or persisting basis. Recurring
means the longitudinal clinical record shows
that the finding(s) satisfies the criteria in the
listing as specified and that pattern has lasted
or is expected to last for a continuous period
of at least 12 months. Persisting means the
longitudinal clinical record shows that, with
few exceptions, the finding(s) has been at, or
is expected to be at, the level specified in the
listing for a continuous period of at least 12
months.
2. Events necessary to meet the listing (e.g.,
3 events within a consecutive 6-month
period) must occur within the period we are
considering in connection with an
application or continuing disability review.
In every listing in which we require more
than one event, there must be at least 1
month between the events (unless otherwise
specified), to ensure that we are evaluating
separate episodes.
D. How do we consider the effects of
treatment?
1. We assess the effect of treatment by
determining if there is improvement in the
symptoms, signs, and laboratory findings of
the disorder, and if there are side effects that
may result in functional limitations. We
assess the effects of medication, therapy,
surgery, or any other form of treatment you
receive, when determining the severity and
the duration of the impairment(s). The
medical evidence should include:
(a) a description of the treatment
prescribed (e.g., the type of medication or
therapy, the use of total parenteral nutrition
(TPN) or enteral nutrition);
(b) dosage, method, and frequency of
administration;
(c) your response to the treatment;
(d) any adverse effects of such treatment;
(e) the expected duration of the treatment.
2. Because treatment itself or the effects of
treatment may be temporary, in most cases
sufficient time must elapse to allow us to
evaluate the impact and expected duration of
treatment and side effects. Where adverse
effects of treatment contribute to the
impairment severity, the duration or
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Jkt 197001
expected duration of the treatment must be
considered in assessing the duration of the
impairment(s).
3. Nutritional therapy. The requirement for
aggressive nutritional therapy, including
parenteral or specialized enteral nutrition to
avoid debilitating complications of a disease
does not, in and of itself, indicate marked
and severe functional limitations, but should
be considered, as any other treatment, in
evaluation of the overall severity of the
impairment.
E. How Do We Evaluate Impairments That Do
Not Meet One of the Digestive Listings?
1. These listings are only examples of
common digestive impairments that we
consider severe enough to result in marked
and severe functional limitations. If your
impairment(s) does not meet the criteria of
any of these listings, we must also consider
whether you have an impairment(s) that
satisfies the criteria of a listing in another
body system. For example:
(a) When liver disease results in hepatic
encephalopathy or hepatic coma, we should
evaluate your impairment(s) under the
criteria for the appropriate mental disorder or
neurological listing(s).
(b) If you have multiple congenital
anomalies, you should be evaluated under
the criteria for the multiple body system
listings (section 110.00) or the criteria for
other appropriate body system(s).
(c) Digestive impairments that interfere
with intake, digestion, and/or absorption of
nutrition, may result in a reduction in the
rate of growth. If such a reduction is not
reflected in the malnutrition listing (105.08),
it may be necessary to refer to the growth
impairment listings for further evaluation of
the impairment.
2. If you haves a medically determinable
impairment(s) that does not meet a listing,
we will determine whether the impairment(s)
medically equals the listings, or, in the case
of a claim for SSI payments under Title XVI,
functionally equals the listings. (See
§§ 404.1526, 416.926, and 416.926a.) When
we decide whether you continue to be
disabled under Title XVI, we use the rules in
§ 416.994a.
F. What Are Our Guidelines For Evaluating
Specific Digestive Impairments?
1. Malnutrition, weight loss and growth
retardation.
(a) Chronic nutritional deficiency.
Gastrointestinal disease may result in
malnutrition. The resulting weight loss or
growth retardation, or both, should be
considered under the criteria of 105.08 and,
if necessary, section 100.00 (growth
impairments) of the listings. To meet the
criteria in 105.08, the malnutrition must be
documented with a laboratory finding(s)
confirming a chronic nutritional deficiency
associated with a gastrointestinal
impairment, which exists despite prescribed
treatment. Such findings include, but are not
limited to, the following:
(1) Severe anemia (hemoglobin less than 8);
(2) Serum albumin less than 3.0 Gm/Del;
(3) Intractable steatorrhea, despite enzyme
therapy, with fecal fat excretion more than:
15% of fat intake in infants less than 6
months; OR
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Fmt 4702
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10% of fat intake in infants 6–18 months;
OR
6% of fat intake in children more than 18
months of age.);
(4) Vitamin, mineral, or trace mineral
deficiency despite aggressive medical and
nutritional therapy.
(b) Body Mass Index (BMI). BMI is the ratio
of your weight to the square of your height.
According to the Centers for Disease Control
and Prevention (CDC), it is the recommended
measure to determine if your weight is
appropriate for your height beginning at 2
years of age. Prior to age 2, the CDC’s weightfor-length charts should be used. A BMI-forage less than the 5th percentile indicates
underweight; a BMI-for-age less than the 3rd
percentile satisfies our criteria for
malnutrition when due to a demonstrable
gastrointestinal or other impairment.
2. Chronic liver disease is liver cell
necrosis, inflammation, or scarring from any
cause, that persists for more than 6 months,
and is expected to continue for at least 12
months. Clinical manifestations may vary
from an asymptomatic state to incapacitation
due to liver failure. Acute hepatic injury is
frequently reversible as in viral, druginduced, and alcoholic hepatitis, and hepatic
ischemia. In the absence of continuing
evidence of a chronic impairment, episodes
of acute liver disease do not necessarily meet
the requirement for chronic liver disease.
(a) Signs and symptoms of chronic liver
disease often include: jaundice (yellow
appearance of the skin and mucous
membranes), intractable pruritis (itching),
ascites, lower extremity edema (swelling due
to large amounts of fluid), gastrointestinal
bleeding, fatigue, nausea, change in mental
status and loss of appetite. Laboratory
findings in cases involving liver disease may
include abnormalities of liver enzymes,
decreased serum albumin, increased
bilirubin, abnormal coagulation studies, and
abnormal liver biopsy.
(b) Liver disease may result in portal
hypertension, bleeding from esophageal
varices, ascites, hepatic encephalopathy,
hepatic coma, and/or liver transplantation.
We should assess impairment due to hepatic
encephalopathy and hepatic coma under the
criteria for the appropriate mental disorder or
neurological listing(s).
(c) Chronic liver disease in children may
cause portal hypertension that precedes or
seems out of proportion to the severity of
hepatocellular injury. You may have chronic
recurrent variceal bleeding, cholestasis
(stoppage or suppression of the flow of bile),
and/or ascites (accumulation of fluid in the
abdominal cavity) well before other features
of liver failure.
(d) Massive hemorrhage from esophageal
varices typically involves hematemesis
(vomiting of blood), melena (passage of dark
stools), or hematochezia (passage of bloody
stools). You may be hemodynamically
unstable as shown by signs and symptoms
such as pallor (paleness), diaphoresis
(profuse perspiration), postural hypotension
(fall in blood pressure when standing), and
syncope (fainting). The situation can be lifethreatening with urgent need for multiple
transfusions and other supportive care.
(e) Liver function tests such as serum
bilirubin or enzyme levels may correlate
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poorly with the clinical severity of liver
disease, and must not be relied upon in
isolation. Ascites, when associated with
either albumin depletion or prolongation of
the prothrombin time, usually indicates
severe loss of liver function. However,
persistent ascites related to chronic liver
disease is an impairment of listing-level
severity in children, regardless of serum
albumin level. Minimal ascites, as might be
detected only by imaging techniques and not
on physical examination, is not sufficient to
meet the criteria in 105.05B.
(f) Liver transplantation may be performed
for progressive liver failure, life-threatening
complications of liver disease, tumor or
trauma. Disability is considered to last for
one year from the date of the transplant. After
that time, we will evaluate your residual
impairment(s), as outlined in paragraph (h)
below.
(g) When we use the phrase ‘‘[c]onsider
under a disability for 1 year following’’ a
specific event, we are making a statement
about the expected duration of disability, not
about the onset of disability. We do not
restrict the determination of disability onset
to the date of the specified event. We can
establish an earlier onset date if you are not
engaging in substantial gainful activity (SGA)
and the evidence in file supports the earlier
onset date of disability.
(h) After the one year period following
transplantation, we evaluate the effects of
any residual impairment(s). Functional
improvement after liver transplant depends
upon various factors, including adequacy of
post-transplant liver function, incidence and
severity of infection, occurrence of rejection
crisis(es), the presence of systemic
complications and the side effects of
immuno-suppressive agents. Growth and
development may also be affected.
3. Esophageal stricture or stenosis
(narrowing) from congenital atresia (absence
or closure of a normal body tubular organ) or
destructive esophagitis may meet the criteria
for malnutrition in listing 105.08. It also may
result in complications that include
respiratory impairments due to frequent
aspiration, problems maintaining nutritional
status short of listing-level severity, or
multiple infections such as pneumonia.
While none of these complications may be of
a severity or persistence to meet the criteria
of another specific listing, the combination
may result in marked and severe functional
limitations.
4. Inflammatory bowel disease under
listing 105.06B. requires an intractable
perineal or intra-abdominal complication
such as intractable fecal incontinence.
Intractable is defined as resistant to cure,
relief or control. There must be evidence of
surgical or medical therapy that has failed to
resolve the complication. Fecal incontinence
involves passage of actual fecal material, not
mere staining or spotting.
105.00 Category of Impairments, Digestive
System
medically acceptable imaging, with at least
three episodes of bleeding requiring
transfusion due to hemodynamic instability,
occurring over a consecutive 6-month period.
Episodes must be separated by at least 1
month. Consider under a disability for 1 year
following last episode; thereafter, evaluate
the residual impairment(s); or
B. Ascites persisting over a consecutive 6month period despite prescribed treatment.
The following findings must be demonstrated
on at least two evaluations occurring at least
2 months apart within the 6-month period:
1. Ascites documented by paracentesis; OR
2. Ascites documented on physical
examination and by appropriate medically
acceptable imaging.
105.06 Inflammatory bowel disease (e.g.,
ulcerative colitis, Crohn’s disease) as
documented by endoscopy, biopsy,
appropriate medically acceptable imaging, or
operative findings WITH:
A. Persistent or recurrent intestinal
obstruction over a consecutive six-month
period, despite prescribed treatment, WITH:
(1) Confirmation, by appropriate medically
acceptable imaging, of stenotic areas in small
intestine or colon with proximal dilatation,
and;
(2) documentation of at least two episodes
of abdominal pain, distention, and vomiting;
OR
B. Perineal or intra-abdominal
complications such as abscess, fistuli or fecal
incontinence; intractable despite medical or
surgical treatment; clinically documented
over a consecutive 6-month period.
105.08 Malnutrition, despite prescribed
treatment, due to gastrointestinal,
hepatobiliary, or pancreatic disease with a
documented sign of chronic nutritional
deficiency, meeting one of the following:
A. For children under age 2, weight-forlength less than the 3rd percentile on the
CDC’s weight-for-length growth charts or data
files, documented at least three times over a
consecutive 6-month period, and expected to
persist for at least 12 months; OR
B. For children age 2 and over, Body Mass
Index (BMI) for age less than the 3rd
percentile on the CDC’s BMI-for-age growth
charts or data files, documented at least three
times over a consecutive 6-month period, and
expected to persist for at least 12 months.
105.09 Liver transplant. Consider under a
disability for 1 year following surgery.
Thereafter, evaluate the residual
impairment(s) (see 105.00F2e.)
*
*
*
*
*
[FR Doc. 01–28455 Filed 11–13–01; 8:45 am]
BILLING CODE 4191–02–P
105.05 Chronic liver disease and cirrhosis
of any kind
WITH:
A. Esophageal varices demonstrated by xray, endoscopy, or other appropriate
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DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[REG–137519–01]
RIN 1545–BA09
Consolidated Returns; Applicability of
Other Provisions of Law; NonApplicability of Section 357(c)
AGENCY: Internal Revenue Service (IRS),
Treasury.
ACTION: Notice of proposed rule-making
and notice of public hearing.
SUMMARY: This document proposes
amendments relating to the
consolidated return regulations dealing
with the non-applicability of section
357(c) in a consolidated group. The
proposed amendments clarify that, in
certain transfers described in section
351 between members of a consolidated
group, a transferee’s assumption of
certain liabilities described in section
357(c)(3) will not reduce the transferor’s
basis in the transferee’s stock received
in the transfer. This document also
provides notice of a public hearing on
these proposed regulations.
DATES: Written or electronic comments
and requests to speak (with outlines of
oral comments to be discussed) at the
public hearing scheduled for March 21,
2002, must be submitted by February
28, 2002.
ADDRESSES: Send submissions to:
CC:ITA:RU (REG–137519–01), room
5226, Internal Revenue Service, POB
7604, Ben Franklin Station, Washington,
DC 20044. Submissions may be hand
delivered Monday through Friday
between the hours of 8 a.m. and 5 p.m.
to: CC:ITA:RU (REG–137519–01),
Courier’s Desk, Internal Revenue
Service, 1111 Constitution Avenue,
NW., Washington, DC. Alternatively,
taxpayers may submit comments
electronically via the internet by
selecting the ‘‘Tax Regs’’ option on the
IRS Home Page, or by submitting
comments directly to the IRS internet
site at http://www.irs.gov/tax_regs/
reglist.html. The public hearing will be
held in room 4718, Internal Revenue
Building, 1111 Constitution Avenue,
NW., Washington, DC.
FOR FURTHER INFORMATION CONTACT:
Concerning the regulations, T. Ian
Russell of the Office of Associate Chief
Counsel (Corporate), (202) 622–7930;
concerning submissions, the hearing,
and/or to be placed on the building
access list to attend the hearing, Donna
M. Poindexter (202–622–7180) (not tollfree numbers).
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| File Type | application/pdf |
| File Title | Document |
| Subject | Extracted Pages |
| Author | U.S. Government Printing Office |
| File Modified | 2006-09-26 |
| File Created | 2006-09-26 |