Rule2023-11771
Revised Medical Criteria for Evaluating Digestive Disorders and Skin Disorders
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 8, 2023
Effective
October 6, 2023
Issuing agencies
Social Security Administration
Abstract
We are revising the criteria in the Listing of Impairments (listings) that we use to evaluate claims involving digestive disorders and skin disorders in adults and children under titles II and XVI of the Social Security Act (Act). The revisions reflect our adjudicative experience, advances in medical knowledge, and comments we received from the public in response to a notice of proposed rulemaking (NPRM).
Full Text
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[Federal Register Volume 88, Number 110 (Thursday, June 8, 2023)]
[Rules and Regulations]
[Pages 37704-37747]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-11771]
[[Page 37703]]
Vol. 88
Thursday,
No. 110
June 8, 2023
Part III
Social Security Administration
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20 CFR Parts 404 and 416
Revised Medical Criteria for Evaluating Digestive Disorders and Skin
Disorders; Final Rule
Federal Register / Vol. 88 , No. 110 / Thursday, June 8, 2023 / Rules
and Regulations
[[Page 37704]]
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SOCIAL SECURITY ADMINISTRATION
20 CFR Parts 404 and 416
[Docket No. SSA-2017-0042]
RIN 0960-AG65
Revised Medical Criteria for Evaluating Digestive Disorders and
Skin Disorders
AGENCY: Social Security Administration.
ACTION: Final rule.
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SUMMARY: We are revising the criteria in the Listing of Impairments
(listings) that we use to evaluate claims involving digestive disorders
and skin disorders in adults and children under titles II and XVI of
the Social Security Act (Act). The revisions reflect our adjudicative
experience, advances in medical knowledge, and comments we received
from the public in response to a notice of proposed rulemaking (NPRM).
DATES: This rule is effective October 6, 2023.
FOR FURTHER INFORMATION CONTACT: Michael J. Goldstein, Office of
Disability Policy, Social Security Administration, 6401 Security
Boulevard, Baltimore, Maryland 21235-6401, (410) 965-1020.
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 site, Social Security Online, at <a href="http://www.socialsecurity.gov">http://www.socialsecurity.gov</a>.
SUPPLEMENTARY INFORMATION:
Background
The listings describe medical conditions that are so severe that we
presume any adult who has a medical condition(s) that satisfies the
criteria of a listing is unable to perform any gainful activity
regardless of their age, education, or work experience and, therefore,
is disabled.\1\ For children, the listings describe impairments we
consider severe enough to cause marked and severe functional
limitations.\2\ We use the listings at step 3 of the sequential
evaluation process to identify claims that we should clearly allow.\3\
We do not deny any claim solely because a person's medical condition(s)
does not satisfy the criteria of a listing.
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\1\ 20 CFR 404.1525(a) and 416.925(a).
\2\ 20 CFR 416.925(a).
\3\ 20 CFR 404.1520, 416.920, and 416.924.
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We last published final rules that revised the digestive disorders
listings on October 19, 2007, and the skin disorders listings on June
9, 2004.\4\ We published an Advance Notice of Proposed Rulemaking
(ANPRM) for digestive disorders in the Federal Register on December 12,
2007.\5\ We published an ANPRM for skin disorders in the Federal
Register on November 10, 2009.\6\
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\4\ 72 FR 59398 (2007) and 69 FR 32260 (2004).
\5\ 72 FR 70527 (2007).
\6\ 74 FR 57972 (2009), with the docket number corrected at 74
FR 62518 (2009).
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We are making final the rule for evaluating digestive disorders and
skin disorders that we proposed in the NPRM published in the Federal
Register on July 25, 2019.\7\ The preamble to the NPRM provides the
background for these revisions. You can view the preamble to the NPRM
by visiting <a href="http://www.regulations.gov">http://www.regulations.gov</a> and searching for document
``SSA-2017-0042.'' There are differences from the NPRM to this final
rule in response to public comments to the NPRM, which we explain
below.
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\7\ 84 FR 35936 (2019).
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Why are we revising the listings for evaluating digestive disorders and
skin disorders?
We developed this final rule as part of our ongoing review of the
listings. We are revising the listings for evaluating digestive
disorders and skin disorders to update their medical criteria, and to
clarify how we evaluate digestive disorders and skin disorders.
When will we begin to use this final rule?
As we noted in the dates section of this preamble, this final rule
will be effective on October 6, 2023. We delayed the effective date of
the rule to give us time to update our systems and to provide training
and guidance to all of our adjudicators before we implement the final
rule. The current rules will continue to apply until the effective date
of the final rule. When the final rule becomes effective, we will apply
it to new applications filed on or after the effective date of the
rule, and to claims that are pending on or after the effective date.\8\
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\8\ This means that we will use this final rule on and after the
effective date in any case in which we make a determination or
decision. We expect that Federal courts will review our final
decisions using the rules that were in effect at the time we issued
the decisions. If a court reverses our final decision and remands a
case for further administrative proceedings after the effective date
of this final rule, we will apply this final rule to the entire
period at issue in the decision we make after the court's remand.
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We present a series of tables below. These tables summarize
revisions we made to the digestive disorders and skin disorders
introductory text and listings. Following the tables, we discuss the
changes in detail.
Digestive Disorders
The following table summarizes the current and revised sections of
the adult digestive disorders introductory text and listings:
------------------------------------------------------------------------
Sections of the Adult
Introductory Text and Listings Revised sections of the Adult
for the digestive system prior to Introductory Text and Listings for
the effective date of this Final digestive disorders
Rule
------------------------------------------------------------------------
Introductory Text, 5.00
------------------------------------------------------------------------
A. What kinds of disorders do we A. Which digestive disorders do we
consider in the digestive evaluate in this body system?
system?.
B. What documentation do we need? B. What evidence do we need to
evaluate your digestive disorder?
C. How do we consider the effects [5.00 H.]
of treatment?.
D. How do we evaluate chronic C. What is chronic liver disease
liver disease?. (CLD), and how do we evaluate it
under 5.05?
E. How do we evaluate D. What is inflammatory bowel disease
inflammatory bowel disease (IBD), and how do we evaluate it
(IBD)?. under 5.06?
F. How do we evaluate short bowel E. What is intestinal failure and how
syndrome (SBS)?. do we evaluate it under 5.07?
G. How do we evaluate weight loss F. How do we evaluate weight loss due
due to any digestive disorder?. to any digestive disorder under
5.08?
[5.00 D.12.]..................... G. How do we evaluate digestive organ
transplantation?
H. What do we mean by the phrase [5.00 C.2. and G.]
``consider under a disability
for 1 year''?.
[5.00 C.6.]...................... H. How do we evaluate your digestive
disorder if there is no record of
ongoing treatment?
I. How do we evaluate your digestive
disorder if there is evidence
establishing a substance use
disorder?
I. How do we evaluate impairments J. How do we evaluate digestive
that do not meet one of the disorders that do not meet one of
digestive disorder listings? these listings?
[[Page 37705]]
Listings
------------------------------------------------------------------------
5.01 Category of Impairments, 5.01 Category of Impairments,
Digestive System. Digestive Disorders
5.02 Gastrointestinal 5.02 Gastrointestinal hemorrhaging
hemorrhaging from any cause, from any cause, requiring three
requiring blood transfusion. blood transfusions
5.03 [Reserved].................. 5.03 [Reserved]
5.04 [Reserved].................. 5.04 [Reserved]
5.05 Chronic liver disease (CLD). 5.05 Chronic liver disease (CLD)
5.06 Inflammatory bowel disease 5.06 Inflammatory bowel disease (IBD)
(IBD).
5.07 Short bowel syndrome (SBS).. 5.07 Intestinal failure
5.08 Weight loss due to any 5.08 Weight loss due to any digestive
digestive disorder. disorder
5.09 Liver transplantation....... 5.09 Liver transplantation
5.10 [Reserved]
5.11 Small intestine transplantation
5.12 Pancreas transplantation
------------------------------------------------------------------------
The following table summarizes the current and revised sections of
the childhood digestive disorders introductory text and listings:
------------------------------------------------------------------------
Sections of the Childhood
Introductory Text and listings Revised sections of the Childhood
for the digestive system prior to Introductory Text and listings for
the effective date of this final digestive disorders
rule
------------------------------------------------------------------------
Introductory Text, 105.00
------------------------------------------------------------------------
A. What kinds of disorders do we A. Which digestive disorders do we
consider in the digestive evaluate in this body system?
system?.
B. What documentation do we need? B. What evidence do we need to
evaluate your digestive disorder?
C. How do we consider the effects [105.00 J.]
of treatment?.
D. How do we evaluate chronic C. What is chronic liver disease
liver disease?. (CLD), and how do we evaluate it
under 105.05?
E. How do we evaluate D. What is inflammatory bowel disease
inflammatory bowel disease (IBD), and how do we evaluate it
(IBD)?. under 105.06?
F. How do we evaluate short bowel E. What is intestinal failure, and
syndrome (SBS)?. how do we evaluate it under 105.07?
G. How do we evaluate growth F. How do we evaluate growth failure
failure due to any digestive due to any digestive disorder under
disorder?. 105.08?
[105.00 D.13.]................... G. How do we evaluate digestive organ
transplantation?
H. How do we evaluate the need H. How do we evaluate the need for
for supplemental daily enteral supplemental daily enteral feeding
feeding via a gastrostomy? via a gastrostomy, duodenostomy, or
jejunostomy?
I. How do we evaluate esophageal I. How do we evaluate esophageal
stricture or stenosis?. stricture or stenosis?
J. What do we mean by the phrase [105.00 C.2., C.4., and G.]
``consider under a disability
for 1 year''?.
[105.00 C.6.].................... J. How do we evaluate your digestive
disorder if there is no record of
ongoing treatment?
K. How do we evaluate your digestive
disorder if there is evidence
establishing a substance use
disorder?
K. How do we evaluate impairments L. How do we evaluate digestive
that do not meet one of the disorders that do not meet one of
digestive disorder listings? these listings?
------------------------------------------------------------------------
Listings
------------------------------------------------------------------------
105.01 Category of Impairments, 105.01 Category of Impairments,
Digestive System. Digestive Disorders
105.02 Gastrointestinal 105.02 Gastrointestinal hemorrhaging
hemorrhaging from any cause, from any cause, requiring three
requiring blood transfusion. blood transfusions
105.03 [Reserved]................ 105.03 [Reserved]
105.04 [Reserved]................ 105.04 [Reserved]
105.05 Chronic liver disease..... 105.05 Chronic liver disease (CLD)
105.06 Inflammatory bowel disease 105.06 Inflammatory bowel disease
(IBD). (IBD)
105.07 Short bowel syndrome (SBS) 105.07 Intestinal failure
105.08 Growth failure due to any 105.08 Growth failure due to any
digestive disorder. digestive disorder
105.09 Liver transplantation..... 105.09 Liver transplantation
105.10 Need for supplemental 105.10 Need for supplemental daily
daily enteral feeding via a enteral feeding via a gastrostomy,
gastrostomy. duodenostomy, or jejunostomy
105.11 Small intestine
transplantation
105.12 Pancreas transplantation
------------------------------------------------------------------------
The following table shows our changes to the adult and childhood
digestive disorders listings criteria that involve changes to
healthcare utilization and condition/episode requirements, the
rationale for each change, and supporting resources. The table first
summarizes the policy changes that apply to multiple adult and
childhood digestive disorders listings and then focuses on changes in
specific listings.
[[Page 37706]]
Adult and Childhood Digestive Disorders Listing Criteria Change in Healthcare Utilization That Applies to
Multiple Listings: Change to 12-Month Timeframe in Listing Criteria Requiring Documentation of Findings on Two
or More Occasions
----------------------------------------------------------------------------------------------------------------
Introductory text or listing criteria
prior to the effective date of this Revised listing Rationale Resources
final rule criteria
----------------------------------------------------------------------------------------------------------------
5.02/105.02 Gastrointestinal 5.02/105.02 The revised text is Section 223(d)(1)(A) of
hemorrhaging from any cause, Gastrointestinal more consistent with the Social Security
requiring blood transfusion (with or hemorrhaging from any our statutory Act.
without hospitalization) of at least cause, requiring three definition of
2 units of blood per transfusion (or blood transfusions of disability; that is,
at least 10 cc of blood/kg of body at least 2 units of the inability to do
weight per transfusion for blood per transfusion, any substantial
children), and occurring at least or at least 10 cc of gainful activity by
three times during a consecutive 6- blood/kg of body reason of any
month-period. The transfusions must weight per medically determinable
be at least 30 days apart within the transfusion, within a physical or mental
6-month period. consecutive 12-month impairment which can
period and at least 30 be expected to result
days apart. in death or which has
lasted or can be
expected to last for a
continuous period of
not less than 12
months.
5.05B/105.05B Chronic liver disease, 5.05B/105.05B Chronic
with: liver disease (CLD)
Ascites or hydrothorax not (see 5.00C) with A, B,
attributable to other causes, C, D, E, F, or G:
despite continuing treatment as Ascites or hydrothorax
prescribed, present on at least 2 not attributable to
evaluations at least 60 days apart other causes (see
within a consecutive 6-month period. 5.00C2b and
Each evaluation must be documented 105.00C2b), present on
by:. two evaluations within
a consecutive 12-month
period and at least 60
days apart. Each
evaluation must
document the ascites
or hydrothorax by 1,
2, or 3:.
5.05F/105.05F Chronic liver disease, 5.05F/105.05F Chronic
with: liver disease (CLD)
Hepatic encephalopathy as described (see 5.00C) with A, B,
in 5.00D10, with 1 and either 2 or C, D, E, F, or G:
3:. Hepatic encephalopathy
1. Documentation of abnormal (see 5.00C2f and
behavior, cognitive dysfunction, 105.00C2f) with
changes in mental status, or altered documentation of
state of consciousness (for example, abnormal behavior,
confusion, delirium, stupor, or cognitive dysfunction,
coma), present on at least two changes in mental
evaluations at least 60 days apart status, or altered
within a consecutive 6-month period;. state of consciousness
3. One of the following occurring on (for example,
at least two evaluations at least 60 confusion, delirium,
days apart within the same stupor, or coma),
consecutive 6-month period as in F1:. present on two
evaluations within a
consecutive 12-month
period and at least 60
days apart and either
1 or 2:.
2. One of the following
on at least two
evaluations at least
60 days apart within
the same consecutive
12-month period as in
F:.
5.05G/105.05G End stage liver disease 5.05G/105.05G Two SSA
with SSA CLD scores of 22 or greater CLD scores (see
calculated as described in 5.00D11. 5.00C3) of at least 20
within a consecutive
12-month period and at
least 60 days apart.
5.06/105.06 Inflammatory bowel 5.06/105.06
disease (IBD) documented by Inflammatory bowel
endoscopy, biopsy, appropriate disease (IBD) (see
medically acceptable imaging, or 5.00D/105.00D)
operative findings with: documented by
A. Obstruction of stenotic areas (not endoscopy, biopsy,
adhesions) in the small intestine or imaging, or operative
colon with proximal dilatation, findings, and
confirmed by appropriate medically demonstrated by A, B,
acceptable imaging or in surgery, or C:
requiring hospitalization for A. Obstruction of
intestinal decompression or for stenotic areas (not
surgery, and occurring on at least adhesions) in the
two occasions at least 60 days apart small intestine or
within a consecutive 6-month period;. colon with proximal
OR................................... dilatation, confirmed
B. Two of the following despite by imaging or in
continuing treatment as prescribed surgery, requiring two
and occurring within the same hospitalizations for
consecutive 6-month period:. intestinal
decompression or for
surgery, within a
consecutive 12-month
period and at least 60
days apart..
OR.....................
B. Two of the following
occurring within a
consecutive 12-month
period and at least 60
days apart:.
5.08 Weight loss due to any digestive 5.08 Weight loss due to
disorder despite continuing any digestive disorder
treatment as prescribed, with body (see 5.00F), despite
mass index (BMI) of less than 17.50 adherence to
calculated on at least two prescribed medical
evaluations at least 60 days apart treatment, with BMI of
within a consecutive 6-month period. less than 17.50
calculated on at least
two evaluations at
least 60 days apart
within a consecutive
12-month period.
----------------------------------------------------------------------------------------------------------------
[[Page 37707]]
Adult and Childhood Digestive Disorders Listings Criteria--Changes in
Healthcare Utilization Introductory Text--5.00/105.00
------------------------------------------------------------------------
Introductory Text
or Listing Revised
Criteria Prior to Introductory Text
the Effective or Listing Rationale Resources
Date of This Criteria
Final Rule
------------------------------------------------------------------------
5.00D/105.00D 5.00/105.00C The revised Organ
(How do we (What is chronic introductory Procurement
evaluate chronic liver disease text adds serum and
liver disease) (CLD) and how do sodium, to be Transplantatio
11. End stage we evaluate it?) considered under n Network &
liver disease 3. SSA Chronic certain United Network
(ESLD) Liver Disease conditions, in for Organ
documented by (SSA CLD) score the CLD formula. Sharing.
scores from the (5.05G/105.05G The Model for (2015).
SSA Chronic \9\). Listing End-Stage Liver Changes to
Liver Disease 5.05G requires Disease (MELD) OPTN bylaws
(SSA CLD) two SSA CLD formula, from and policies
calculation scores, each which the CLD from actions
(5.05G/ requiring three formula is based at OPTN/UNOS
105.05G1). or four and is the Executive
b. To calculate laboratory mathematical Committee
the SSA CLD values. The equivalent to, meetings July
score, we use a ``date of the was updated in 2015-November
formula that SSA CLD score'' 2016 to add the 2015 [PDF].
includes three is the date of serum sodium https://
laboratory the earliest of levels. We added optn.transplan
values: Serum the three or serum sodium t.hrsa.gov/
total bilirubin four laboratory levels because, media/1575/
(mg/dL), serum values used for for individuals policynotice_2
creatinine (mg/ its calculation. with certain 0151101.pdf.
dL), and The date of the liver conditions Vaa, B.E.,
International second SSA CLD such as Asrani, S.K.,
Normalized Ratio score must be at alcoholic Dunn, W.,
(INR). least 60 days hepatitis and Kamath, P.S.,
after the date cirrhosis, & Shah, V.H.
of the first SSA medical research (2011).
CLD score and shows serum Influence of
both scores must sodium levels serum sodium
be within the predict negative on MELD-based
required 12- outcomes more survival
month period. If accurately than prediction in
you have the two formulas without alcoholic
SSA CLD scores it. hepatitis.
required by Mayo Clinic
5.05G, we will Proceedings,
find that your 86(1), 37-42.
impairment meets Londo[ntilde]o,
the criteria of M.-C.,
the listing from C[aacute]rdena
at least the s, A.,
date of the Guevara, M.,
first SSA CLD Quint[oacute],
score. L., de las
a. We calculate Heras, D.,
the SSA CLD Navasa, M.,
score using a Rimola, A.,
formula that Garcia-
includes up to Valdecasas, J.-
four laboratory C., Arroya,
values: Serum V., &
creatinine (mg/ Gin[egrave]s,
dL), total P. (2007).
bilirubin (mg/ MELD score and
dL), INR, and serum sodium
under certain in the
conditions, prediction of
serum sodium survival of
(mmol/L). The patients with
SSA CLD score cirrhosis
calculation awaiting liver
contains at transplantatio
least one, and n. Gut, 56(9),
sometimes two, 1283-1290.
parts, as https://
described in (i) doi.org/
and (ii). 10.1136/
gut.2006.10276
4.
------------------------------------------------------------------------
Listing 5.05/105.05 Chronic Liver Disease (CLD)
------------------------------------------------------------------------
5.05G/105.05G End 5.05G/105.05G Two The revised Annamalai, A.,
stage liver SSA CLD scores listing reduces Harada, M.,
disease with SSA (see 5.00C3) of the current Chen, M.,
CLD scores of 22 at least 20 listing level Tran, T., Ko,
or greater within a end stage liver A., Ley, E., .
calculated as consecutive 12- disease CLD . . Noureddin,
described in month period and score of 22 to M. (2016).
5.00D11. at least 60 days 20. Two scores Predictors of
apart. of at least 20 mortality in
accurately the critically
identify ill cirrhotic
advanced, end patient: Is
stage liver the model for
disease that end-stage
prevents a liver disease
person from enough?
working and, Journal of the
without a liver American
transplant, will College of
ultimately Surgeons,
result in death. 224(3), 276-
The unchanged 282. https://
requirement of a doi.org/
second score at 10.1016/
least 60 days j.jamcollsurg.
after the first 2016.11.005.
score is to Zhiang, E.,
confirm Zhang, Z.,
chronicity, Want, S.,
which is Xiao, Z., Gu,
critical for J., Xiong, M.,
confirming . . . Huang,
continued Z. (2016).
severity. We Predicting the
have also severity of
modified this liver
score for cirrhosis
children above through
the age of 12 in clinical
the childhood parameters.
listing (see Journal of
105.05G2). Surgical
Research,
204(2), 274-
281. <a href="https://doi.org/10.1016/j.jss.2016.04.036">https://doi.org/10.1016/j.jss.2016.04.036</a> 036.
Singal, A.K. &
Kamath, P.S.
(2013). Model
for end-stage
liver disease.
Journal of
Clinical and
Experimental
Hepatology,
3(1), 50-60.
<a href="https://doi.org/10.1016/j.jceh.2012.11.002">https://doi.org/10.1016/j.jceh.2012.11.002</a>.
Bittermann, T.,
Makar, G., &
Goldberg, D.S.
(2015). Early
post-
transplant
survival:
Interaction of
MELD score and
hospitalizatio
n status.
Journal of
Hepatology,
63(3), 601-
608. <a href="https://www.sciencedirect.com/science/article/pii/S0168827815002445?via%3Dihub">https://www.sciencedirect.com/science/article/pii/S0168827815002445?via%3Dihub</a>
.
------------------------------------------------------------------------
[[Page 37708]]
Listing 5.06/105.06 Inflammatory Bowel Disease (IBD)
------------------------------------------------------------------------
5.06B/105.06B 5.06B/105.06B The revised 20 CFR 404.1530
Inflammatory Inflammatory listing text and 416.930.
bowel disease bowel disease removes the Need to follow
(IBD) documented (IBD) (see 5.00D requirement that prescribed
by endoscopy, and 105.00D) pain not be treatment.
biopsy, documented by completely SSR 18-3p:
appropriate endoscopy, controlled by Titles II and
medically biopsy, imaging, prescribed XVI: Failure
acceptable or operative narcotic to Follow
imaging, or findings, and medication. If a Prescribed
operative demonstrated by person is Treatment.
findings with: A, B, or C: prescribed any
Two of the Two of the medication,
following following including opioid
despite occurring within or other
continuing a consecutive 12- narcotic
treatment as month period and medication, and
prescribed and at least 60 days chooses to not
occurring within apart: take the
the same 3. Clinically medication, we
consecutive 6- documented use our rules
month period: tender abdominal regarding the
3. Clinically mass palpable on need to follow
documented physical prescribed
tender abdominal examination with treatment, which
mass palpable on abdominal pain apply to all
physical or cramping; or medical
examination with 4. Perianal conditions, not
abdominal pain disease with a just digestive
or cramping that draining abscess disorders. In
is not or fistula; or subregulatory
completely policy, we also
controlled by include the
prescribed ``risk of
narcotic addiction to
medication, opioid
present on at medication'' as
least two an example of a
evaluations at ``good cause''
least 60 days reason for not
apart; or following
4. Perineal prescribed
disease with a treatment.''
draining abscess Since it is
or fistula, with already our
pain that is not policy that a
completely lack of, or
controlled by reduction of,
prescribed opioid or
narcotic narcotic
medication, prescriptions
present on at due to the risk
least two of addiction
evaluations at will not
least 60 days adversely affect
apart; or a person's claim
during the
adjudication
process, we
removed
consideration of
narcotic
medication from
these listings.
5.06B/105.06B 5.06B/105.06B The revised Public comment:
Inflammatory Inflammatory listing expands https://
bowel disease bowel disease the alternative www.regulation
(IBD) documented (IBD) (see 5.00D method of s.gov/comment/
by endoscopy, and 105.00D) supplemental SSA-2017-0042-
biopsy, documented by daily enteral 0008.
appropriate endoscopy, nutrition to Pearce, C.B. &
medically biopsy, imaging, meet the listing Duncan, H.D.
acceptable or operative to include (2002).
imaging, or findings, and duodenostomy and Enteral
operative demonstrated by jejunostomy. We feeding.
findings with: A, B, or C: added these two Nasogastric,
6 (5 for 5. Need for additional nasojejunal,
childhood). Need supplemental methods of tube percutaneous
for supplemental daily enteral feeding after we endoscopic
daily enteral nutrition via a received public gastrostomy,
nutrition via a gastrostomy, comment or
gastrostomy or duodenostomy, or requesting that jejunostomy:
daily parenteral jejunostomy, or we expand tube its
nutrition via a daily parenteral feedings to indications
central venous nutrition via a those beyond and
catheter. central venous gastric which limitations,
catheter. are often Postgraduate
required in Medical
patients with Journal, 78,
digestive 198-204.
disorders. <a href="https://doi.10.1136/pmj.78.918.198">https://doi.10.1136/pmj.78.918.198</a>
.
Brett, K. &
Arg[aacute]ez,
C. (2018).
Gastrostomy
versus
gastrojejunost
omy and/or
jejunostomy
feeding tubes:
a review of
clinical
effectiveness,
cost-
effectiveness
and
guidelines.
Ottawa (ON):
Canadian
Agency for
Drugs and
Technologies
in Health.
Clinical
Nutrition
University.
(2021, May
25). Types of
Feeding Tubes
EXPLAINED.
YouTube.
<a href="https://www.youtube.com/watch?v=4Oam1yUHiO8">https://www.youtube.com/watch?v=4Oam1yUHiO8</a> UHiO8.
[[Page 37709]]
No current 5.06C Repeated The revised Farraye, F.A.,
listing criteria complications of listing combines Melmed, G.Y.,
IBD (see required medical Lichtenstein,
5.00D5a), findings with G.R., & Kane,
occurring an specific S.V. (2017).
average of three limitations in ACG clinical
times a year, or functioning to guidelines:
once every 4 identify IBD of Preventative
months, each listing-level care in
lasting 2 weeks severity. inflammatory
or more, within Specifically, bowel disease.
a consecutive 12- the revised American
month period, listing adds a Journal of
and marked criterion for Gastroenterolo
limitation (see repeated gy, 112(2),
5.00D5c) in one complications of 241-258.
of the IBD that result Gajendran, M.,
following: in marked Loganathan,
1. Activities of limitation in at P., Catinella,
daily living least one area A.P., &
(see 5.00D5d); of functioning. Hashash, J.G.
or This combination (2018). A
2. Maintaining of findings comprehensive
social accurately review and
functioning (see characterizes update on
5.00D5e); or complications of Crohn's
3. Completing IBD that prevent disease.
tasks in a a person from Disease-a-
timely manner engaging in any Month, 64, 20-
due to gainful 57.
deficiencies in activity. Rubin, D.T.,
concentration, The addition of Ananthakrishna
persistence, or functional n, A.N.,
pace (see criteria is also Siegel, C.A.,
5.00D5f). consistent with Sauer, B.G., &
the listings Long, M.D.
that already (2019). ACG
include these clinical
same functional guidelines:
criteria, which Ulcerative
are 7.18 colitis in
(Repeated adults.
complications of American
hematological Journal of
disorders), Gastroenterolo
14.02B (Repeated gy, 114(3),
manifestations 384-413.
of systemic Yarur, A.J.,
lupus Strobel, S.G.,
erythematosus), Deshpande,
14.04D (Repeated A.R., & Abreu,
manifestations M.T. (2011).
of systemic Predictors of
sclerosis), aggressive
14.05E (Repeated inflammatory
manifestations bowel disease.
of polymyositis Gastroenterolo
or gy &
dermatomyositis) Hepatology,
, 14.06B 7(10), 652-
(Repeated 659.
manifestations
of
undifferentiated
or mixed
connective
tissue disease),
14.07C (Repeated
manifestations
of an immune
deficiency
disorder),
14.09D (Repeated
manifestations
of inflammatory
arthritis),
14.10B
(Sj[ouml]gren's
syndrome), and
14.11I (Repeated
manifestations
of HIV
infection).
------------------------------------------------------------------------
Listing 5.07/105.07 Intestinal Failure
------------------------------------------------------------------------
5.07/105.07 Short 5.07/105.07 The revised Public comment:
bowel syndrome Intestinal listing more https://
(SBS), due to failure (see broadly www.regulation
surgical 5.00E) due to addresses s.gov/comment/
resection of short bowel intestinal SSA-2017-0042-
more than one- syndrome, failure with 0015.
half of the chronic motility need for Thompson J.S.,
small intestine, disorders, or parenteral Rochling FA,
with dependence extensive small nutrition and Weseman R.A.,
on daily bowel mucosal covers a greater Mercer D.F.
parenteral disease, range of chronic Current
nutrition via a resulting in dysmotility or management of
central venous dependence on absent motility short bowel
catheter (see daily parenteral disorders. We syndrome. Curr
5.00F). nutrition via a adopted a public Probl Surg
central venous comment 49:52-115,
catheter for at requesting this 2012. https://
least 12 months. change to doi.org/
account for 10.1067/
individuals who j.cpsurg.2011.
have intestinal 10.002.
conditions that Pironi, L.,
may exist Arends, J.,
without the Baxter, J.,
surgery Bozzetti, F.,
requirement of Pel[aacute]ez,
short bowel R.B., Cuerda,
syndrome (the C., Forbes,
current A., Gabe, S.,
listing). Gillanders,
L., Holst, M.,
Jeppesen,
P.B., Joly,
F., Kelly, D.,
Klek, S.,
Irtun,
[Oslash].,
Olde Damink,
S.W., Panisic,
M., Rasmussen,
H.H., Staun,
M.,
Szczepanek,
K., . . .
Acute
Intestinal
Failure
Special
Interest
Groups of
ESPEN (2015).
ESPEN endorsed
recommendation
s. Definition
and
classification
of intestinal
failure in
adults.
Clinical
nutrition
(Edinburgh,
Scotland),
34(2), 171-
180. <a href="https://doi.org/10.1016/j.clnu.2014.08.017">https://doi.org/10.1016/j.clnu.2014.08.017</a>.
[[Page 37710]]
Pironi, L.,
Arends, J.,
Bozzetti, F.,
Cuerda, C.,
Gillanders,
L., Jeppesen,
P.B., Joly,
F., Kelly, D.,
Lal, S.,
Staun, M.,
Szczepanek,
K., Van
Gossum, A.,
Wanten, G.,
Schneider,
S.M., & Home
Artificial
Nutrition &
Chronic
Intestinal
Failure
Special
Interest Group
of ESPEN
(2016). ESPEN
guidelines on
chronic
intestinal
failure in
adults.
Clinical
nutrition
(Edinburgh,
Scotland),
35(2), 247-
307. <a href="https://doi.org/10.1016/j.clnu.2016.01.020">https://doi.org/10.1016/j.clnu.2016.01.020</a>.
Deutsch, L.,
Cloutier, A.,
& Lal, S.
(2020).
Advances in
chronic
intestinal
failure
management and
therapies.
Current
opinion in
gastroenterolo
gy, 36(3), 223-
229. <a href="https://doi.org/10.1097/MOG.0000000000000631">https://doi.org/10.1097/MOG.0000000000000631</a> 000631.
Pierret, A.,
Wilkinson,
J.T.,
Zilbauer, M.,
& Mann, J.P.
(2019).
Clinical
outcomes in
pediatric
intestinal
failure: a
meta-analysis
and meta-
regression.
The American
journal of
clinical
nutrition,
110(2), 430-
436. <a href="https://doi.org/10.1093/ajcn/nqz110">https://doi.org/10.1093/ajcn/nqz110</a> nqz110.
------------------------------------------------------------------------
Listing 105.10 Need for supplemental daily enteral feeding via a
gastrostomy, duodenostomy, or jejunostomy
------------------------------------------------------------------------
105.10 Need for 105.10 Need for The revised Public comment:
supplemental supplemental listing expands https://
daily enteral daily enteral the alternative www.regulation
feeding via a feeding via a method of s.gov/comment/
gastrostomy due gastrostomy, supplemental SSA-2017-0042-
to any cause, duodenostomy, or daily enteral 0008.
for children who jejunostomy (see nutrition to
have not 105.00H) due to meet the listing
attained age 3; any cause, for to include
thereafter, children who duodenostomy and
evaluate the have not jejunostomy. We
residual attained age 3; added these two
impairment(s) after that, additional
(see 105.00H). evaluate the methods of tube
residual feeding after we
impairment(s). received public
comment
requesting that
we expand tube
feedings to
those beyond
gastric which
are often
required in
patients with
digestive
disorders.
------------------------------------------------------------------------
Skin Disorders
The following table summarizes the current and revised sections of
the adult skin disorders introductory text and listings.
---------------------------------------------------------------------------
\9\ The childhood digestive disorders listing includes SSA CLD-P
scores (see 105.00C3). We are not proposing changes to the SSA CLD-P
formula. This table discusses changes to the SSA CLD formula only.
------------------------------------------------------------------------
Sections of the Adult
Introductory Text and listings Revised sections of the Adult
for skin disorders prior to the Introductory Text and Listings for
effective date of this final rule Skin Disorders
------------------------------------------------------------------------
Introductory Text, 8.00
------------------------------------------------------------------------
A. What skin disorders do we A. Which skin disorders do we
evaluate with these listings?. evaluate under these listings?
B. What documentation do we need? [8.00C]
[8.00C].......................... B. What are our definitions for the
following terms used in this body
system?
C. How do we assess the severity [8.00D]
of your skin disorder(s)?.
[8.00B].......................... C. What evidence do we need to
evaluate your skin disorder?
D. How do we assess impairments [8.00H]
that may affect the skin and
other body systems?
[8.00C].......................... D. How do we evaluate the severity of
skin disorders?
E. How do we evaluate genetic E. How do we evaluate genetic
photosensitivity disorders?. photosensitivity disorders under
8.07?
F. How do we evaluate burns?..... F. How do we evaluate burns under
8.08?
G. How do we determine if your [8.00D]
skin disorder(s) will continue
at a disabling level of severity
in order to meet the duration
requirement?.
[8.00C].......................... G. How do we evaluate chronic
conditions of the skin or mucous
membranes under 8.09?
H. How do we assess your skin [8.00I]
disorder(s) if your impairment
does not meet the requirements
of one of these listings?
[8.00D].......................... H. How do we evaluate disorders in
other body systems that affect the
skin?
[8.00H].......................... I. How do we evaluate skin disorders
that do not meet one of these
listings?
------------------------------------------------------------------------
Listings
------------------------------------------------------------------------
8.01 Category of Impairments, 8.01 Category of Impairments, Skin
Skin Disorders. Disorders
8.02 Ichthyosis.................. 8.02 [Reserved] [Now evaluated in
8.09]
[[Page 37711]]
8.03 Bullous disease............. 8.03 [Reserved] [Now evaluated in
8.09]
8.04 Chronic infections of the 8.04 [Reserved] [Now evaluated in
skin or mucous membranes. 8.09]
8.05 Dermatitis.................. 8.05 [Reserved] [Now evaluated in
8.09]
8.06 Hidradenitis suppurativa.... 8.06 [Reserved] [Now evaluated in
8.09]
8.07 Genetic photosensitivity 8.07 Genetic photosensitivity
disorders. disorders
8.08 Burns....................... 8.08 Burns
[8.02-8.06]...................... 8.09 Chronic conditions of the skin
or mucous membranes
------------------------------------------------------------------------
The following table summarizes the current and revised sections of
the childhood skin disorders introductory text and listings.
------------------------------------------------------------------------
Sections of the Childhood
Introductory Text and listings Revised sections of the Childhood
for skin disorders prior to the Introductory Text and listings for
effective date of this final rule skin disorders
------------------------------------------------------------------------
Introductory Text, 108.00
------------------------------------------------------------------------
A. What skin disorders do we A. Which skin disorders do we
evaluate with these listings?. evaluate under these listings?
B. What documentation do we need? [108.00C]
[108.00C]........................ B. What are our definitions for the
following terms used in this body
system?
C. How do we assess the severity [108.00D]
of your skin disorder(s)?.
[108.00B]........................ C. What evidence do we need to
evaluate your skin disorder?
D. How do we assess impairments [108.00H]
that may affect the skin and
other body systems?.
[108.00C]........................ D. How do we evaluate the severity of
skin disorders?
E. How do we evaluate genetic E. How do we evaluate genetic
photosensitivity disorders?. photosensitivity disorders under
108.07?
F. How do we evaluate burns?..... F. How do we evaluate burns under
108.08?
G. How do we determine if your [108.00D]
skin disorder(s) will continue
at a disabling level of severity
in order to meet the duration
requirement?.
[108.00C]........................ G. How do we evaluate chronic
conditions of the skin or mucous
membranes under 108.09?
H. How do we assess your skin [108.00I]
disorder(s) if your impairment
does not meet the requirements
of one of these listings?
[108.00D]........................ H. How do we evaluate disorders in
other body systems that affect the
skin?
[108.00H]........................ I. How do we evaluate skin disorders
that do not meet one of these
listings?
------------------------------------------------------------------------
Listings
------------------------------------------------------------------------
108.01 Category of Impairments, 108.01 Category of Impairments, Skin
Skin Disorders. Disorders
108.02 Ichthyosis................ 108.02 [Reserved] [Now evaluated in
108.09]
108.03 Bullous disease........... 108.03 [Reserved] [Now evaluated in
108.09]
108.04 Chronic infections of the 108.04 [Reserved] [Now evaluated in
skin or mucous membranes. 108.09]
108.05 Dermatitis................ 108.05 [Reserved] [Now evaluated in
108.09]
108.06 Hidradenitis suppurativa.. 108.06 [Reserved] [Now evaluated in
108.09]
108.07 Genetic photosensitivity 108.07 Genetic photosensitivity
disorders. disorders
108.08 Burns..................... 108.08 Burns
[108.02-108.06].................. 108.09 Chronic conditions of the skin
or mucous membranes
------------------------------------------------------------------------
The following table shows our changes to the adult and childhood
skin disorders listings criteria that involve changes to healthcare
utilization and condition/episode requirements, the rationale for each
change, and supporting resources.
[[Page 37712]]
Adult and Childhood Skin Disorders Listings Criteria--Changes in
Healthcare Utilization and Condition/Episode Requirements
------------------------------------------------------------------------
Introductory text
or listing Revised
criteria prior to Introductory text
the effective or listing Rationale Resources
date of this criteria
final rule
------------------------------------------------------------------------
Introductory Text--8.00/108.00
------------------------------------------------------------------------
No current 8.00D5/108.00D5 The revised Farahnik, B.,
introductory c. Treatment with introductory Nakamura, M.,
text PUVA (psoralen text about Singh, R.K.,
and ultraviolet deferment for Abrouk, M.,
A (UVA) light) PUVA treatment Zhu, T.H., Lee,
or biologics. If is supported by K.M., . . .
you receive medical Liao, W.
additional research. PUVA (2016). The
treatment with treatment patient's guide
PUVA or involves to psoriasis
biologics to exposure to UVA treatment. Part
treat your skin light after 2: PUVA
disorder(s), we taking biologic phototherapy.
will defer medication Dermatology and
adjudication of called psoralen Therapy, 6(3),
your claim for 6 that increases 315-324. https:/
months from the the skin's /doi.org/
start of sensitivity to 10.1007/s13555-
treatment with ultraviolent 016-0130-9.
PUVA or light. PUVA is Ong, S., &
biologics to generally used Venning, V.
evaluate the under medical (2014). PUVA
effectiveness of supervision treatment
these treatments when other information for
unless we can conservative patients.
make a fully treatments for Retrieved from
favorable skin disorders Oxford
determination or have proven to University
decision on be ineffective. Hospital NHS
another basis We defer website: https:/
adjudication /www.ouh.nhs.uk/
for 6 months patient-guide/
from the start leaflets/files/
of treatment to 120719puva.pdf.
assess the Shenoi, S.D., &
effectiveness Prabhu, S.
of PUVA (2014).
treatment on Photochemothera
the skin py (PUVA) in
condition psoriasis and
vitiligo.
Indian Journal
of Dermatology,
Venereology and
Leprology,
80(6), 497-504.
<a href="https://doi.org/10.4103/0378-6323.144143">https://doi.org/10.4103/0378-6323.144143</a>.
------------------------------------------------------------------------
[[Page 37713]]
8.07/108.07 Genetic photosensitivity disorders
------------------------------------------------------------------------
8.07/108.07 8.07/108.07 The requirement 44 FR 18170,
Genetic Genetic that the 18187 (1979),
photosensitivity photosensitivity claimant's skin 45 FR 55566,
disorders, disorders, disorder 55607 (1980),
established as established as results in and 50 FR
described in described in significant 50068, 50098
8.00E and 8.00E and functional (1985).
108.00E 108.00E. The limitations Falder, S.,
B. Other genetic requirements of lasting a Browne, A.,
photosensitivity this listing are minimum of 12 Edgar, D.,
disorders, with: met if either months dates Staples, E.,
1. Extensive skin paragraph A or back to Fong, J., Rea,
lesions that paragraph B is 1979.\10\ The S., & Wood, F.
have lasted or satisfied language in the (2009). Core
can be expected B. Other genetic revised listing outcomes for
to last for a photosensitivity reflects a adult burn
continuous disorders (see continuation of survivors: A
period of at 8.00E2 and this clinical
least 12 months, 108.00E2) with requirement, overview.
OR either 1 or 2: stating that we Burns, 35(5),
2. Inability to 2. Chronic skin must have 618-641. https:/
function outside lesions (see medically /doi.org/
of a highly 8.00B2 and documented 10.1016/
protective 108.00B2) or evidence of j.burns.2008.09
environment for contractures physical .002; Haslik,
a continuous (see 8.00B3 and limitation(s) W., Kamolz, L.,
period of at 108.00B3) of functioning Manna, F.,
least 12 months causing chronic related to the Hladik, M.,
(see 8.00E2 and pain or other claimant's skin Rath, T., &
108.00E2) physical disorder, and Frey, M.
limitation(s) that the (2010).
that result in decrease in Management of
impairment- physical full-thickness
related function skin defects in
functional resulting from the hand and
limitations (see the claimant's wrist region:
8.00D2 and skin disorder First long-term
108.00D2), as must have experiences
evidenced by: lasted, or can with the dermal
a. Inability to be expected to matrix
use both upper last, for a Matriderm[supre
extremities to continuous g]. Journal of
the extent that period of at Plastic,
neither can be least 12 months Reconstructive
used to The revised & Aesthetic
independently functional Surgery, 63(2),
initiate, criteria focus 360-364. https:/
sustain, and on the person's /doi.org/
complete work- ability to use 10.1016/
related their upper and j.bjps.2008.09.
activities (or lower 026; Wasiak,
age-appropriate extremities to J., Lee, S.,
activities in perform work- Paul, E.,
childhood related Mahar, P.,
claims) activities or Pfitzer, B.,
involving fine engage in age- Spinks, A., . .
and gross appropriate . Gabbe, B.
movements (see activities in (2014).
8.00B5 and childhood Predictors of
108.00B5) due to claims. These health status
chronic skin revisions and health-
lesions (see reflect our related quality
8.00B2 and continued focus of life 12
108.00B2) or on the months after
contractures functional severe burn.
(see 8.00B3 and limitations Burns, 40(4),
108.00B3); or that skin 568-574;
b. Inability to disorders may 81 FR 43048
use one upper cause and (2016).
extremity to reflect a level
independently of functional
initiate, limitation
sustain, and similar to the
complete work- criteria in our
related current rules.
activities (or We clarify our
age-appropriate policy by
activities in providing
childhood precise
claims) functional
involving fine criteria rather
and gross than examples
movements (see as in the
8.00B5 and current skin
108.00B5) due to disorders
chronic skin listings to
lesions (see ensure that
8.00B2 and adjudicators do
108.00B2) or not overlook
contractures the functional
(see 8.00B3 and criteria and
108.00B3), and a that we
documented evaluate
medical need functional
(see 8.00B4 and limitations
108.00B4) for an caused by a
assistive device person's skin
(see 8.00B1 and impairment in a
108.00B1) that consistent
requires the use manner across
of the other cases
upper extremity; Additionally,
or the revised
c. Inability to requirement
stand up from a that the
seated position claimant have
and maintain an significant
upright position limitations in
to the extent the use of two
needed to extremities is
independently consistent with
initiate, the level of
sustain, and functional
complete work- limitations set
related forth in other
activities (or listing
age-appropriate criteria, such
activities in as in our
childhood neurological
claims) due to disorders
chronic skin listings (11.00/
lesions (see 111.00), which
8.00B2 and require
108.00B2) or ``disorganizati
contractures on of motor
(see 8.00B3 and function'' in
108.00B3) two extremities
affecting at
least two
extremities
(including when
limitations are
due to
involvement of
the perineum or
the inguinal
region); or
d. Inability to
maintain an
upright position
while standing
or walking to
the extent
needed to
independently
initiate,
sustain, and
complete work-
related
activities (or
age-appropriate
activities in
childhood
claims), due to
chronic skin
lesions (see
8.00B2 and
108.00B2) or
contractures
(see 8.00B3 and
108.00B3)
affecting both
lower
extremities
(including when
the limitations
are due to
involvement of
the perineum or
the inguinal
region).
------------------------------------------------------------------------
[[Page 37714]]
Listing 8.08/108.08 Burns
------------------------------------------------------------------------
8.08/108.08 8.08/108.08 Burns The requirement 44 FR 18170,
Burns, with (see 8.00F and that the 18187 (1979),
extensive skin 108.00F). Burns claimant's skin 45 FR 55566,
lesions that that do not disorder 55607 (1980),
have lasted or require results in and 50 FR
can be expected continuing significant 50068, 50098
to last for a surgical functional (1985).
continuous management (see limitations Falder, S.,
period of at 8.00B6 and lasting a Browne, A.,
least 12 months 108.00B6), or minimum of 12 Edgar, D.,
(see 8.00F and that have been months dates Staples, E.,
108.00F) documented by an back to Fong, J., Rea,
acceptable 1979.\11\ The S., & Wood, F.
medical source language in the (2009). Core
to have reached revised listing outcomes for
maximum reflects a adult burn
therapeutic continuation of survivors: A
benefit and this clinical
therefore are no requirement, overview.
longer receiving stating that we Burns, 35(5),
surgical must have 618-641. https:/
management, medically /doi.org/
resulting in documented 10.1016/
chronic skin evidence of j.burns.2008.09
lesions (see physical .002; Haslik,
8.00B2 and limitation(s) W., Kamolz, L.,
108.00B2) or of functioning Manna, F.,
contractures related to the Hladik, M.,
(see 8.00B3 and claimant's skin Rath, T., &
108.00B3) disorder, and Frey, M.
causing chronic that the (2010).
pain or other decrease in Management of
physical physical full-thickness
limitation(s) function skin defects in
that result in resulting from the hand and
impairment- the claimant's wrist region:
related skin disorder First long-term
functional must have experiences
limitations (see lasted, or can with the dermal
8.00D2 and be expected to matrix
108.00D2), as last, for a Matriderm[supre
evidenced by: continuous g]. Journal of
The functional period of at Plastic,
criteria set least 12 months Reconstructive
forth above in The revised & Aesthetic
listings 8.07B2a functional Surgery, 63(2),
through d and criteria, focus 360-364. https:/
108.07B2a on the person's /doi.org/
through d ability to use 10.1016/
their upper and j.bjps.2008.09.
lower 026; Wasiak,
extremities to J., Lee, S.,
perform work- Paul, E.,
related Mahar, P.,
activities or Pfitzer, B.,
engage in age- Spinks, A., . .
appropriate . Gabbe, B.
activities in (2014).
childhood Predictors of
claims. These health status
revisions and health-
reflect our related quality
continued focus of life 12
on the months after
functional severe burn.
limitations Burns, 40(4),
that skin 568-574;
disorders may 81 FR 43048
cause and (2016).
reflect a level
of functional
limitation
similar to the
criteria in our
current rules.
We clarify our
policy by
providing
precise
functional
criteria rather
than examples
as in the
current skin
disorders
listings to
ensure that
adjudicators do
not overlook
the functional
criteria and
that we
evaluate
functional
limitations
caused by a
person's skin
impairment in a
consistent
manner across
cases
Additionally,
the revised
requirement
that the
claimant have
significant
limitations in
the use of two
extremities is
consistent with
the level of
functional
limitations set
forth in other
listing
criteria, such
as in our
neurological
disorders
listings (11.00/
111.00), which
require
``disorganizati
on of motor
function'' in
two extremities
------------------------------------------------------------------------
[[Page 37715]]
Listing 8.09/108.09 Chronic conditions of the skin or mucous membranes
------------------------------------------------------------------------
No current 8.09/108.09 We consolidated 20 CFR 404.1509
listing. Note Chronic the current and 416.909.
that current conditions of listings into 44 FR 18170,
listings 8.02/ the skin or one listing for 18187 (1979),
108.02 mucous membranes adjudicative 45 FR 55566,
(Ichthyosis), (see 8.00G and ease and to 55607 (1980),
8.03/108/03 108.00G) more and 50 FR
(Bullous resulting in: efficiently 50068, 50098
disease), 8.04 A. Chronic skin capture adults (1985).
(Chronic lesions (see and children Falder, S.,
infections of 8.00B2 and with chronic Browne, A.,
the skin or 108.00B2) or skin conditions Edgar, D.,
mucous contractures of listing- Staples, E.,
membranes), 8.05 (see 8.00B3 and level severity. Fong, J., Rea,
(Dermatitis), 108.00B3) The requirement S., & Wood, F.
and 8.06 causing chronic that the (2009). Core
(Hidradenitis pain or other claimant's skin outcomes for
suppurativa) all physical disorder adult burn
require limitation(s) results in survivors: A
extensive skin that persist significant clinical
lesions that despite functional overview.
persist for at adherence to limitations Burns, 35(5),
least 3 months prescribed lasting a 618-641. https:/
despite medical minimum of 12 /doi.org/
continued treatment for 3 months dates 10.1016/
treatment as months (see back to j.burns.2008.09
prescribed. 8.00D5b and 1979.\12\ The .002; Haslik,
Under the 108.00D5b language in the W., Kamolz, L.,
revised skin AND revised listing Manna, F.,
disorders Impairment- reflects a Hladik, M.,
listings, all of related continuation of Rath, T., &
these skin functional this Frey, M.
conditions will limitations requirement, (2010).
be evaluated demonstrated by stating that we Management of
under listing the functional must have full-thickness
8.09/108.09. criteria set medically skin defects in
forth above in documented the hand and
listings 8.07B2a evidence of wrist region:
through d and physical First long-term
108.07B2a limitation(s) experiences
through d. of functioning with the dermal
related to the matrix
claimant's skin Matriderm[supre
disorder, and g]. Journal of
that the Plastic,
decrease in Reconstructive
physical & Aesthetic
function Surgery, 63(2),
resulting from 360-364. https:/
the claimant's /doi.org/
skin disorder 10.1016/
must have j.bjps.2008.09.
lasted, or can 026; Wasiak,
be expected to J., Lee, S.,
last, for a Paul, E.,
continuous Mahar, P.,
period of at Pfitzer, B.,
least 12 Spinks, A., . .
months. . Gabbe, B.
The revised (2014).
functional Predictors of
criteria focus health status
on the person's and health-
ability to use related quality
their upper and of life 12
lower months after
extremities to severe burn.
perform work- Burns, 40(4),
related 568-574;
activities or 81 FR 43048
engage in age- (2016).
appropriate
activities in
childhood
claims. These
revisions
reflect our
continued focus
on the
functional
limitations
that skin
disorders may
cause and
reflect a level
of functional
limitation
similar to the
criteria in our
current rules.
We clarify our
policy by
providing
precise
functional
criteria rather
than examples
as in the
current skin
disorders
listings to
ensure that
adjudicators do
not overlook
the functional
criteria and
that we
evaluate
functional
limitations
caused by a
person's skin
impairment in a
consistent
manner across
cases.
Additionally,
the revised
requirement
that the
claimant have
significant
limitations in
the use of two
extremities is
consistent with
the level of
functional
limitations set
forth in other
listing
criteria, such
as in our
neurological
disorders
listings (11.00/
111.00), which
require
``disorganizati
on of motor
function'' in
two
extremities.
------------------------------------------------------------------------
The following table shows our changes to references to BMI in other
body systems. Prior to the effective date of this final rule, the
formulas for calculating BMI are referenced as appearing in 5.00G and
105.00G2c in various listings, and we are correcting these references
to reflect the revised digestive disorders listings.
---------------------------------------------------------------------------
\10\ The introductory text to our 1979 final rule stated that
the claimant's skin lesions ``must be shown to have persisted for a
sufficient period of time despite therapy for a reasonable
presumption to be made that severe impairment will last for a
continuous period of at least 12 months.'' 44 FR at 18787.
\11\ Id.
\12\ Id.
----------------------------------------------------------------------------------------------------------------
Introductory Text prior to the effective Revised Introductory Text with updated
Listing paragraph date of this Final Rule cross-references
----------------------------------------------------------------------------------------------------------------
6.00C7.................... Anorexia (diminished appetite) with Anorexia (diminished appetite) with
weight loss. Anorexia is a frequent sign weight loss. Anorexia is a frequent sign
of CKD and can result in weight loss. We of CKD and can result in weight loss. We
will use body mass index (BMI) to will use body mass index (BMI) to
determine the severity of your weight determine the severity of your weight
loss under 6.05B4. (BMI is the ratio of loss under 6.05B4. (BMI is the ratio of
your measured weight to the square of your measured weight to the square of
your measured height.) The formula for your measured height.) We calculate your
calculating BMI is in section 5.00G. BMI using the formulas in the digestive
disorders body system (5.00).
[[Page 37716]]
14.00F5................... Measurement of CD4 and either body mass Measurement of CD4 and either body mass
index or hemoglobin (14.11G). To index or hemoglobin (14.11G). To
evaluate your HIV infection under evaluate your HIV infection under
14.11G, we require one measurement of 14.11G, we require one measurement of
your absolute CD4 count or your CD4 your absolute CD4 count or your CD4
percentage, and either a measurement of percentage, and either a measurement of
your body mass index (BMI) or your your body mass index (BMI) or your
hemoglobin. These measurements must hemoglobin. These measurements must
occur within the period we are occur within the period we are
considering in connection with your considering in connection with your
application or continuing disability application or continuing disability
review. If you have more than one review. If you have more than one
measurement of your CD4 (absolute count measurement of your CD4 (absolute count
or percentage), BMI, or hemoglobin or percentage), BMI, or hemoglobin
within this period, we will use the within this period, we will use the
lowest of your CD4 (absolute count or lowest of your CD4 (absolute count or
percentage), BMI, or hemoglobin. The percentage), BMI, or hemoglobin. The
date of your lowest CD4 (absolute count date of your lowest CD4 (absolute count
or percentage) measurement may be or percentage) measurement may be
different from the date of your lowest different from the date of your lowest
BMI or hemoglobin measurement. We BMI or hemoglobin measurement. We
calculate your BMI using the formulas in calculate your BMI using the formulas in
5.00G2. the digestive disorders body system
(5.00).
100.00C2c................. BMI is the ratio of a child's weight to BMI is the ratio of a child's weight to
the square of his or her height. We the square of his or her height. We
calculate BMI using the formulas in calculate BMI using the formulas in the
105.00G2c. digestive disorders body system
(105.00).
103.00K2c................. BMI is the ratio of a child's weight to BMI is the ratio of a child's weight to
the square of his or her height. We the square of his or her height. We
calculate BMI using the formulas in calculate BMI using the formulas in the
105.00G2c. digestive disorders body system
(105.00).
104.00C3b(iii)............ BMI is the ratio of a child's weight to BMI is the ratio of a child's weight to
the square of his or her height. We the square of his or her height. We
calculate BMI using the formulas in calculate BMI using the formulas in the
105.00G2c. digestive disorders body system
(105.00).
106.00C5b(iii)............ BMI is the ratio of a child's weight to BMI is the ratio of a child's weight to
the square of his or her height. We the square of his or her height. We
calculate BMI using the formulas in calculate BMI using the formulas in the
105.00G2c. digestive disorders body system
(105.00).
114.00F7b(iii)............ BMI is the ratio of a child's weight to BMI is the ratio of a child's weight to
the square of his or her height. We the square of his or her height. We
calculate BMI using the formulas in calculate BMI using the formulas in the
105.00G2c. digestive disorders body system
(105.00).
----------------------------------------------------------------------------------------------------------------
We are making several changes from the NPRM to this final rule for
digestive disorders and skin disorders:
<bullet> The following is a high-level summary of the major changes
from the NPRM to this final rule. Below, in the section titled Public
Comments on the NPRM, we describe in greater detail our response to
questions and public comments, as well as changes from the NPRM to this
final rule. Further, these responses provide additional details about
our rule changes from our current rules, through the NPRM, and to our
final rule for digestive disorders and skin disorders.
<bullet> We also made minor, editorial changes from the NPRM for
clarity and readability throughout both digestive disorders and skin
disorders.
Digestive Disorders
<bullet> Hepatopulmonary syndrome: We revised the regulatory text
for hepatopulmonary syndrome to describe relevant clinical findings
associated with this complication of chronic liver disease (CLD)
(5.00C2 and 105.00C2 (Manifestations of CLD)).
<bullet> SSA Chronic Liver Disease (SSA CLD) and SSA Chronic Liver
Disease-Pediatric (SSA CLD-P) scores: In the introductory text to the
listing, we modified the SSA CLD calculation. We added a sentence to
clarify that if you have the two SSA CLD scores required by 5.05G
(``Two SSA CLD scores'') and 105.05G1 (``For children age 12 and
older''), we will find that your impairment meets the criteria of the
listing from at least the date of the first SSA CLD score (5.00C3 (SSA
Chronic Liver Disease (SSA CLD) score) and 105.00C3 (SSA Chronic Liver
Disease (SSA CLD) and SSA Chronic Liver Disease-Pediatric (SSA CLD-P)
scores); 5.05G (``Two SSA CLD scores'') and 105.05G1 (``For children
age 12 or older''). We also removed the reference to SSA CLD-P scores
in 105.05G1 (``For children age 12 or older'').
<bullet> Inflammatory bowel disease (IBD): In the listing
introductory text, we added perianal disease and extraintestinal
manifestations with examples for each. We also clarified the
consideration of surgical diversion of the intestinal tract (5.00D and
105.00D (What is inflammatory bowel disease (IBD), and how do we
evaluate it under 5.06/105.06)). We retained the consideration of
anemia and serum albumin from the current criteria in revised listings
5.06B1, 5.06B2, 105.06B1 and 105.06B2.
<bullet> Supplemental nutrition: We expanded the listing
introductory text and criteria for the alternative method of
supplemental daily enteral nutrition to meet the listing to include
duodenostomy or jejunostomy (5.06B and 105.06B (``Two of the following
occurring within a consecutive 12-month period'') and 105.10 (Need for
supplemental daily enteral feeding via a gastrostomy, duodenostomy, or
jejunostomy)).
<bullet> Intestinal failure: We expanded the listing introductory
text and criteria for short bowel syndrome (SBS) to include intestinal
failure and added descriptions of different types of intestinal failure
(5.00E and 105.00E (What is intestinal failure, and how do we evaluate
it under 5.07/105.07?); 5.07 and 105.07 (Intestinal failure)).
<bullet> Weight loss due to any digestive disorder: We retained the
current criteria, for weight loss due to any digestive disorder, rather
than finalizing the proposed criteria for malnutrition due to any
digestive disorder (5.00F (How do we evaluate weight loss due to any
digestive disorder under 5.08?) and 5.08 (Weight loss due to any
digestive disorder)). Although it is not a policy change, in this final
rule, we also updated the language in the listing text to refer to
``adherence to prescribed medical treatment'' instead of ``continuing
treatment as prescribed,'' for consistency with medical terminology and
the changes we made to the skin disorders listings. Additionally, we
added language to the introductory text in 5.00F (How do we evaluate
weight loss due to any digestive disorder under 5.08?) and 105.00F (How
do we evaluate growth failure due to any digestive disorder under
105.08?) to explain how we consider weight loss or growth failure due
to impairments other than digestive disorders.
<bullet> Chronic liver disease: We reorganized the criteria in
5.05A and 105.05A (``Hemorrhaging from esophageal, gastric, or ectopic
varices'') to use an outline format rather than text paragraphs. We did
this to improve clarity and readability, but there were no substantive
changes to the criteria.
<bullet> References to BMI in other body systems: As we finalize
revisions to the
[[Page 37717]]
digestive disorders listings, we are revising cross references in other
body systems to correct citations to the BMI formula because they will
be outdated once this rule is effective. Specifically, we made these
revisions to 6.00C7, 14.00F5, 100.00C2c, 103.00K2c, 104.00C3b(iii),
106.00C5b(iii), and 114.00F7b(iii).
Skin Disorders
<bullet> Definitions: We added assistive devices used in a seated
position to the list of examples of assistive devices. We also added a
definition for exacerbation (8.00B and 108.00B (What are our
definitions for the following terms used in this body system?)).
<bullet> Evidence: We clarified that we consider any available
history of familial incidence (8.00C and 108.00C (What evidence do we
need to evaluate your skin disorder?)).
<bullet> Functional criteria: We clarified that the inability to
perform fine and gross movements is due to chronic skin lesions or
contractures, consistent with the other two functional criteria (8.00D2
and 108.00D2 (Limitation(s) of physical functioning due to skin
disorders)).
<bullet> Adherence to prescribed treatment: We changed the term
``physician'' to ``medical source'' in 8.00D5b and 108.00D5b (Despite
adherence to prescribed medical treatment for 3 months) to include
treatment prescribed by any medical source.\13\
---------------------------------------------------------------------------
\13\ 20 CFR 404.1502(d) and 416.902(i).
---------------------------------------------------------------------------
<bullet> Burns: We removed the ``third-degree'' qualifier in front
of burns (8.00F and 108.00F (How do we evaluate burns under 8.08/
108.08); 8.08 and 108.08 (Burns)).
<bullet> Improving Clarity and Readability: We revised the language
in 8.07B2 and 108.07B2 (``Chronic skin lesions or contractures''), 8.08
and 108.08 (Burns), and 8.09 and 108.09 (Chronic conditions of the skin
or mucous membranes) to remove repetitive language and make the
criteria easier to understand and apply.
Public Comments on the NPRM
In the NPRM, we provided the public with a 60-day comment period,
which ended on September 23, 2019. We received 14 comments. The
comments came from advocacy groups, legal services organizations, a
State agency that makes disability determinations for us, medical
organizations, and individual commenters. Multiple commenters provided
identical (or very similar) comments and recommendations.
We carefully considered all of the comments related to this
rulemaking. We have tried to summarize the commenters' views accurately
and have responded to all of the significant issues raised by the
commenters that were within the scope of this rule. We have not
summarized or responded to comments that were outside the scope of the
proposed rule. Some commenters noted provisions with which they agreed
but did not make suggestions for changes in those provisions. We did
not summarize or respond to those comments.
Digestive Disorders
Chronic Liver Disease (CLD)
Comment: Two commenters suggested that we use the Model for End-
Stage Liver Disease (MELD) formula rather than the SSA CLD formula. One
commenter suggested we use the MELD formula so we could keep pace with
changes in the treatment of digestive disorders without having to
update our regulations. Another commenter noted that even when SSA CLD
scores are available in the medical record, they are not used by SSA
adjudicators, and requested that we use the SSA CLD scores when
available. The commenter suggested that if the SSA CLD is unavailable,
we use the MELD scores when available in the medical record.
Response: We partially adopted this comment. In the 2007 Revised
Medical Criteria for Evaluating Digestive Disorders final rule, we
explained that the MELD is a numerical scale developed for the United
Network for Organ Sharing (UNOS) that is used to determine a person's
placement on the liver transplant list within the Organ Procurement and
Transplant Network (OPTN).\14\ The MELD score is based on objective and
verifiable medical data and estimates a person's risk of dying while
waiting for a liver transplant. In 2016, the MELD formula was modified
to take serum sodium levels into account under certain
situations.<SUP>15 16</SUP>
---------------------------------------------------------------------------
\14\ 72 FR 59398 (2007).
\15\ Organ Procurement and Transplantation Network & United
Network for Organ Sharing. (2015). Changes to OPTN bylaws and
policies from actions at OPTN/UNOS Executive Committee meetings July
2015-November 2015 [PDF]. <a href="https://optn.transplant.hrsa.gov/media/1575/policynotice_20151101.pdf">https://optn.transplant.hrsa.gov/media/1575/policynotice_20151101.pdf</a>.
\16\ United Network for Organ Sharing. (2016). Policy and system
changes effective January 11, 2016, adding serum sodium to MELD
calculation. <a href="https://unos.org/news/policy-and-system-changes-effective-january-11-2016-adding-serum-sodium-to-meld-calculation/">https://unos.org/news/policy-and-system-changes-effective-january-11-2016-adding-serum-sodium-to-meld-calculation/</a>.
---------------------------------------------------------------------------
The SSA CLD calculation under the current rules was the
mathematical equivalent to the MELD formula used in 2007, and we
initially proposed no changes to this calculation in the
NPRM.<SUP>17 18</SUP> However, in response to comments that we adopt
the MELD formula, we reviewed the updated 2016 MELD formula and
assessed its use in our disability program. We learned that for people
with certain chronic liver diseases, formulas utilizing serum sodium
levels predict negative outcomes more accurately than formulas that do
not consider serum sodium levels.<SUP>19 20</SUP> As a result, we
modified the SSA CLD calculation to also account for serum sodium
levels under certain situations, so it remains mathematically
equivalent to the new MELD calculation. However, we did not directly
adopt the commenters' suggestion that we reference the MELD score in
our listing criteria, for reasons explained below.
---------------------------------------------------------------------------
\17\ 72 FR 59398 (2007).
\18\ 84 FR 35936 (2019).
\19\ Vaa, B.E., Asrani, S.K., Dunn, W., Kamath, P.S., & Shah,
V.H. (2011). Influence of serum sodium on MELD-based survival
prediction in alcoholic hepatitis. Mayo Clinic Proceedings, 86(1),
37-42. <a href="https://doi.org/10.4065/mcp.2010.0281">https://doi.org/10.4065/mcp.2010.0281</a>.
\20\ Londo[ntilde]o, M.-C., C[aacute]rdenas, A., Guevara, M.,
Quint[oacute], L., de las Heras, D., Navasa, M., Rimola, A., Garcia-
Valdecasas, J.-C., Arroya, V., & Gin[egrave]s, P. (2007). MELD score
and serum sodium in the prediction of survival of patients with
cirrhosis awaiting liver transplantation. Gut, 56(9), 1283-1290.
<a href="https://doi.org/10.1136/gut.2006.102764">https://doi.org/10.1136/gut.2006.102764</a>.
---------------------------------------------------------------------------
As demonstrated in the table below, the SSA CLD and the MELD are
nearly identical, aside from the placement of a multiplier. Despite
this difference, the two formulas yield identical results.
---------------------------------------------------------------------------
\21\ International Normalized Ratio (INR) is a common laboratory
test that measures the amount of time it takes for the blood to
clot.
------------------------------------------------------------------------
MELD SSA CLD
------------------------------------------------------------------------
[0.378 * loge(bilirubin)) + (1.120 * (3.78 * loge(bilirubin)) +
loge(INR \21\)) + (0.957 * (11.20 * loge(INR)) + (9.57 *
loge(creatinine)) + 0.643] * 10. loge(creatinine)) + 6.43.
------------------------------------------------------------------------
If resulting value (MELD(i)) or SSA CLD(i)) is 12 or greater, the serum
sodium value is considered in the following way:
------------------------------------------------------------------------
MELD(i) + 1.32 * (137-Na)- SSA CLD(i) + 1.32 * (137-Na)-
[0.033*MELD(i) * (137-Na)]. [0.033*SSA CLD(i) * (137-Na)].
------------------------------------------------------------------------
[[Page 37718]]
We modified the SSA CLD formula rather than directly adopting the
MELD formula for multiple reasons. First, we use the SSA CLD score for
different purposes than the medical community uses the MELD score.
Specifically, MELD scores are used to determine a person's placement on
the liver transplant list, while SSA CLD scores are used to determine
whether a person's chronic liver disease is severe enough to preclude
the performance of any gainful activity. While our analysis shows that
the new SSA CLD calculation, which is mathematically equivalent to the
current MELD calculation, is appropriate for our programmatic use,
going forward, our analysis and research may determine that a SSA CLD
calculation which differs from the MELD calculation is more appropriate
for a determination of listing-level chronic liver disease. Likewise,
the MELD calculation may change in a way that precludes us from using
it to determine listing-level chronic liver disease. Because the MELD
is maintained by an independent entity, we may not know of the change
until it is in effect, and therefore would be tied to using an
inappropriate formula until we were able to publish a regulatory
change. In such instances, it is important that we retain flexibility
and use our own calculation, rather than adopt the MELD formula, as the
commenter suggests.
Moreover, the SSA CLD has unique testing standards that are
consistent with our programmatic requirements. For instance, for the
SSA CLD, we require that all laboratory values be obtained within a
continuous 30-day period, and we do not use any INR values derived from
testing done while the claimant is on anticoagulant treatment. These
requirements are not in place for the MELD calculation (see 5.00C3 (SSA
Chronic Liver Disease (SSA CLD) score) and 105.00C3a (SSA CLD score)).
Finally, the SSA CLD score is familiar to our adjudicators because we
began using it in 2007.
The commenter also misunderstands our use of SSA CLD scores.
Because SSA CLD scores result from our regulatory formula, they are
generally not available in the medical record, nor do we expect them to
be. Instead, adjudicators must calculate the SSA CLD score using a
formula that includes up to four laboratory values. The calculation is
set forth in our regulations at 5.00C3 (SSA Chronic Liver Disease (SSA
CLD) score) and 105.00C3a (SSA CLD score). Regardless of the formula
used, we require the component values be present in the medical
evidence of record, and then our adjudicators input those values into a
calculator to determine the score based on the regulatory formula.
With regard to our changes to the SSA CLD formula, we describe the
modified SSA CLD calculation in the introductory text in this final
rule in paragraphs 5.00C3 (SSA Chronic Liver Disease (SSA CLD) score)
and 105.00C3a (SSA CLD score). We reorganized the order of paragraphs
5.00C3b (``For any SSA CLD calculation'') and 5.00C3c (``When we
indicate `log<INF>e</INF>' '') and 105.00C3a(ii) (``For any SSA CLD
calculation'') and 105.00C3a(iii) (``When we indicate `log<INF>e</INF>'
'') for clarity. We updated the instructions for rounding and limits
for maximum and minimum values in paragraphs 5.00C3b and 105.00C3a(ii)
(``For any SSA CLD calculation'') to reflect the addition of serum
sodium to the CLD formula. Finally, we updated the CLD calculation
examples in paragraphs 5.00C3c and 105.00C3a(iii) (``When we indicate
`log<INF>e</INF>' '') to reflect the change in the formula.
Comment: One commenter stated that we do not provide evidence that
SSA CLD scores greater than or equal to 20 are a measure of the ability
or inability to engage in substantial gainful activity (SGA).
Response: We disagree. The rule change reflects medical research
showing the increased 3-month mortality risk and overall clinical
severity indicated by laboratory values resulting in an SSA CLD score
of at least 20.<SUP>22 23 24</SUP> For instance, individuals with a
MELD score ranging from 10-19 have a 3-month mortality rate of 6%,
whereas individuals with a MELD score between 20 and 29 have a 3-month
mortality rate of 19.6%, which means they are more than three times
more likely to die within 3 months if they do not receive a
transplant.\25\ As explained above, the MELD score is equivalent to the
SSA CLD score. This degree of severity is consistent with liver disease
that will prevent an adult from engaging in any gainful activity,
result in death, or cause marked and severe limitations in children
over the age of 12. Clinical practice uses the MELD formula, which we
describe above as equivalent to the SSA CLD, to evaluate liver disease
for individuals age 12 and older. However, because the formula that our
SSA CLD-P score is based on is only used for individuals under age 12,
we removed listing criteria considering an SSA CLD-P score of at least
20 from revised listing 105.05G1 (``For children age 12 and older'')
that was initially included in the NPRM.
---------------------------------------------------------------------------
\22\ Singal, A.K., & Kamath, P.S. (2012). Model for end-stage
liver disease. Journal of Clinical and Experimental Hepatology,
3(1), 50-60. <a href="https://doi.org/10.1016/j.jceh.2012.11.002">https://doi.org/10.1016/j.jceh.2012.11.002</a>.
\23\ Zhang, E.-L., Zhang, Z.-Y., Wang, S.-P., Xiao, Z.-Y, Gu,
J., Xiong, M, Chen, X.-P., & Huang, Z.-Y. (2016). Predicting the
severity of liver cirrhosis through clinical parameters. Journal of
Surgical Research, 204(2), 274-281. <a href="https://doi.org/10.1016/j.jss.2016.04.036">https://doi.org/10.1016/j.jss.2016.04.036</a>.
\24\ Thornton, K. (2021, February 12). Evaluation and Prognosis
of Persons with Cirrhosis. Hepatitis C Online. <a href="https://www.hepatitisc.uw.edu/go/evaluation-staging-monitoring/evaluation-prognosis-cirrhosis/core-concept/all">https://www.hepatitisc.uw.edu/go/evaluation-staging-monitoring/evaluation-prognosis-cirrhosis/core-concept/all</a>.
\25\ Id.
---------------------------------------------------------------------------
The SSA CLD-P is based on the Pediatric Model for End Stage Liver
Disease (or the PELD), which was also developed by OPTN, and is used
for organ transplant allocation for persons under the age of 12. Unlike
the MELD, the PELD has not been changed since prior to the publication
of our 2007 revisions to the digestive disorders listings, where we
created the SSA CLD-P formula, as an equivalent to the PELD, to
evaluate liver disease under listing 105.05G2 (``For children who have
not attained age 12'').\26\ Similar to an SSA CLD score of at least 20,
medical research shows an increased 3-month mortality risk and overall
clinical severity indicated by laboratory values that result in an SSA
CLD-P score of at least 11.\27\ This level of severity continues to
identify liver disease severe enough to cause marked and severe
limitations in children under the age of 12. We therefore did not
propose a change to the existing SSA CLD-P formula in the NPRM, nor
were there public comments suggesting a revision to our formula based
on PELD.
---------------------------------------------------------------------------
\26\ 72 FR 59398 (2007).
\27\ Chung-Chou, H.C., Bryce, C.L., Shneider, B.L., Yabes, J.G.,
Ren, Y., Zenarosa, G.L., Tomko, H., Donnell, D.M., Squires, R.H., &
Roberts, M.S. (2018). Accuracy of the pediatric end-stage liver
disease score in estimating pretransplant mortality among pediatric
liver transplant candidates. JAMA Pediatrics, 172(11), 1070-1077.
<a href="https://doi.org/10.1001/jamapediatrics.2018.2541">https://doi.org/10.1001/jamapediatrics.2018.2541</a>.
---------------------------------------------------------------------------
The commenter did not provide any alternatives or suggestions on
the revised text. Additionally, the commenter misstates the function of
our listings regarding gainful activity by using the phrase
``substantial gainful activity.'' The listings describe impairments
that we consider severe enough to prevent an adult from doing any
gainful activity.\28\ For children, the listings describe impairments
we consider severe enough to cause marked and severe functional
limitations.\29\
---------------------------------------------------------------------------
\28\ 20 CFR 404.1525(a) and 416.925(a).
\29\ 20 CFR 416.925(a).
---------------------------------------------------------------------------
Comment: Several commenters asked us to keep the current listing
direction in 5.05G and 105.05G (``End stage liver disease'') or replace
it with suggested text. The commenters suggested the
[[Page 37719]]
listing criteria should, ``consider [the person] under a disability no
later than the date of the first score'' for the required two SSA CLD
scores.
Response: We agree with the commenters. The current listing
language states we ``[c]onsider under a disability from at least the
date of the first score.'' While we proposed to remove this direction
in the NPRM, we did not intend to change our policy in the current rule
that we consider an individual under a disability from at least the
date of their first score. At the commenters' request and to avoid
confusion on this issue, we are no longer making the change proposed in
the NPRM and have retained the current listing direction to ``consider
under a disability from at least the date of the first score'' in
listings 5.05G (``Two SSA CLD scores'') and 105.05G1 (``For children
age 12 or older''). We also included applicable corresponding
introductory text in the final rule introductory paragraphs 5.00C3 (SSA
Chronic Liver Disease (SSA CLD) score) and 105.00C3a (SSA CLD score).
Comment: One commenter expressed that our proposed change to
listing 5.05G (``Two SSA CLD scores'') and 105.05G1 (``For children age
12 or older'') constitutes a new requirement for two SSA CLD scores and
would make a finding of disability dependent on access to expensive
care instead of medical considerations.
Response: We disagree with the characterization that it is a new
requirement that two SSA CLD scores are required to make a finding of
disability under the listing. Our current rules, at 5.00D11e (``Listing
5.05G requires two SSA CLD scores'') and 105.00D11a(v) (``Listing
105.05G requires two SSA CLD scores'') state that two SSA CLD scores
are required. The language ``[c]onsider under a disability from at
least the date of the first score'' does not mean the second SSA CLD
score is optional under 5.05G (``Two SSA CLD scores'') or 105.05G1
(``For children age 12 or older'').
Comment: One commenter suggested that we clarify the definition of
gastrointestinal hemorrhaging, which is necessary to establish listing-
level severity. To that end, the commenter suggested adding information
about clinical findings on endoscopy to proposed listing 5.05A
(``Hemorrhaging from esophageal, gastric, or ectopic varices'').
Response: We did not adopt this comment, because hemodynamic
instability findings, and the need for hospitalization for transfusion
of at least two units of blood, are the defining characteristics of
hemorrhage of listing-level severity under revised listing 5.05A
(``Hemorrhaging from esophageal, gastric, or ectopic varices'').
Although the underlying hemorrhage documented by imaging is a
requirement under revised listing 5.05A (``Hemorrhaging from
esophageal, gastric, or ectopic varices''), this imaging alone does not
establish listing-level severity. In addition to hemorrhaging from
esophageal, gastric, or ectopic varices, or from portal hypertensive
gastropathy documented by imaging, listing 5.05A (``Hemorrhaging from
esophageal, gastric, or ectopic varices'') also requires both the
finding of hemodynamic instability and hospitalization for transfusion
of at least two units of blood. We consider the suggested endoscopic
findings when they are present in the medical evidence.
Comment: Several commenters asked us to allow the use of pulse
oximetry results to demonstrate hepatopulmonary syndrome in listings
5.05E and 105.05E (``Hepatopulmonary syndrome''). One commenter
expressed concern about the appropriateness of arterial blood gas (ABG)
testing (as required under proposed 105.05E1 (``Arterial PaO2 measured
by an ABG test'')) in young children due to difficulties in
administration on young children.
Response: We did not adopt these comments. ABG testing is the
widely-accepted standard test for confirmatory diagnosis of hypoxemia
in suspected hepatopulmonary syndrome, regardless of the patient's
age.\30\ Although there can be some difficulties with administering ABG
tests on young children, such as bleeding, risks associated with
getting an ABG are relatively minor, and ABG testing remains the most
valid indicator of listing-level severity.<SUP>31 32 33</SUP> Although
pulse oximetry is useful to screen a patient for hepatopulmonary
syndrome, it is generally not used as a diagnostic test, due to a risk
of false positives.\34\ The literature cited by the commenters stated
that ABG testing would still be required for final determination of
hepatopulmonary syndrome severity after any screening with pulse
oximetry.\35\ Furthermore, pulse oximetry is not as accurate as ABG
tests in cases of very low oxygen saturation, and may also be affected
by the use of certain cosmetics, skin pigmentation, or poor peripheral
circulation.\36\
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\30\ Grilo-Bensusan, I., & Pascasio-Acevedo, J.M. (2016).
Hepatopulmonary syndrome: What we know and what we would like to
know. World Journal of Gastroenterology, 22(5), 5728-5741. <a href="https://doi.org/10.3748/wjg.v22.i25.5728">https://doi.org/10.3748/wjg.v22.i25.5728</a>.
\31\ Forde K.A., Fallon M.B., Krowka M.J., Sprys M., Goldberg
D.S., Krok K.L., Patel, M., Lin, G., Oh, J.K., Mottram, C.D.,
Scanlon, P.D., & Kawut S.M. (2019). Pulse oximetry is insensitive
for detection of hepatopulmonary syndrome in patients evaluated for
liver transplantation. Hepatology, 69(1), 270-281. <a href="https://doi.org/10.1002/hep.30139">https://doi.org/10.1002/hep.30139</a>.
\32\ Noli, K., Solomon, M., Golding, F., Charron, M., & Ling,
S.C. (2008). Prevalence of hepatopulmonary syndrome in children.
Pediatrics, 121(3), e522-527. <a href="https://doi.org/10.1542/peds.2007-1075">https://doi.org/10.1542/peds.2007-1075</a>.
\33\ Arterial Blood Gas (ABG): What It Is, Purpose, Procedure &
Levels. (2022, February 18.). Cleveland Clinic. <a href="https://my.clevelandclinic.org/health/diagnostics/22409-arterial-blood-gas-abg">https://my.clevelandclinic.org/health/diagnostics/22409-arterial-blood-gas-abg</a>.
\34\ Arguedas, M.R., Singh, H., Faulk, D.K., & Fallon, M.B.
(2007). Utility of pulse oximetry screening for hepatopulmonary
syndrome. Clinical Gasteroenterology and Hepatology, 5(6), 749-754.
<a href="https://doi.org/10.1016/j.cgh.2006.12.003">https://doi.org/10.1016/j.cgh.2006.12.003</a>.
\35\ Id.
\36\ Jubran, A. (2015). Pulse oximetry. Critical Care, 19, 272.
<a href="https://doi.org/10.1186/s13054-015-0984-8">https://doi.org/10.1186/s13054-015-0984-8</a>.
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We consider all evidence in the case record when we evaluate claims
for disability benefits, including laboratory test results as a form of
objective medical evidence.\37\ If an impairment(s) does not satisfy
the listing requirement for an ABG measurement, then we will consider
whether the impairment(s) medically equals a listing.\38\ If an adult's
impairment(s) does not meet or medically equal any listing, they can be
found disabled at a later step in the sequential evaluation
process.\39\ If a child's impairment(s) does not meet or medically
equal any listing, including because the medical evidence in the record
does not contain necessary laboratory test results, we may find that
their impairment(s) functionally equals the listings.\40\ It is at this
stage that we would use all available medical and non-medical evidence
to evaluate whether a child's impairment(s) functionally equals the
listings, including pulse oximetry results.
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\37\ 20 CFR 404.1520, 416.920, and 416.924.
\38\ 20 CFR 404.1526 and 416.926.
\39\ 20 CFR 404.1520 and 416.920.
\40\ 20 CFR 416.924.
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Comment: Several commenters requested that, if we do not permit the
use of pulse oximetry results for listings 5.05E and 105.05E
(``Hepatopulmonary syndrome''), that we state that we will purchase ABG
testing for people with hepatopulmonary syndrome who have pulse
oximetry values below 96%.
Response: We did not adopt the comment. We do not require a
consultative examination in every case where there is evidence of a
pulse oximetry value below 96%. Our regulations governing the purchase
of consultative examinations already state that if we cannot obtain the
information we need from a claimant's medical sources to make a
determination or decision of disability, or when the other available
evidence on a claim is
[[Page 37720]]
insufficient, we may purchase the needed medical examinations or tests,
but this is an individualized and fact-specific determination.
Therefore, it would be inappropriate, and inconsistent with our
regulations, for SSA to purchase ABG testing when there are no
inconsistencies in the evidence, or when the evidence in the file is
sufficient to make a determination or decision on a claim.\41\
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\41\ 20 CFR 404.1519a and 416.919a.
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Comment: Commenters requested that we include a statement in
listings 5.05E and 105.05E (``Hepatopulmonary syndrome'') that
hypoxemia due to hepatopulmonary syndrome may also be evaluated under
listing 3.02C2 (Chronic respiratory disorders) or the childhood
respiratory listings. For proposed criterion in listing 5.05E1
(``Arterial P<INF>a</INF>O<INF>2</INF> measured by an ABG test''), one
commenter asked us to either use both P<INF>a</INF>O<INF>2</INF> and
P<INF>a</INF>CO<INF>2</INF> values, or the highest favorable
P<INF>a</INF>O<INF>2</INF> for each altitude range, as noted in tables
for P<INF>a</INF>O<INF>2</INF>/P<INF>a</INF>CO<INF>2</INF> measurements
in the respiratory listing for hypoxemia.
Response: We did not adopt these comments. Hepatopulmonary syndrome
is not the same as hypoxemia caused by a chronic respiratory disorder.
Hepatopulmonary syndrome is not a respiratory disease. It is a rare
complication of liver disease, characterized by arterial deoxygenation
due to intrapulmonary vascular dilation and arteriovenous
shunting.<SUP>42 43</SUP> Hypoxemia is defined as a below-normal level
of oxygen in the blood, specifically in the arteries.\44\ The only
effective treatment for hepatopulmonary syndrome is liver transplant.
Severity grading of hepatopulmonary syndrome is based on measurements
of P<INF>a</INF>O<INF>2,</INF> not P<INF>a</INF>CO<INF>2</INF>, and
5.05E1 and 105.05E1 consider altitude when determining whether a
claimant's hepatopulmonary syndrome is listing-level
severity.<SUP>45 46</SUP> For these reasons, we are not including a
syndrome caused by liver disease in a respiratory listing. However, in
the regulatory text of the NPRM and the final rule, we state in
paragraphs 5.00J2 and 105.00L2 (``If you have a severe medically
determinable impairment(s) that does not meet a listing'') that if a
person's impairment(s) does not meet the requirements of a listing in
any body system, we may find that the impairment(s) is medically
equivalent to another listing. An impairment(s) is medically equivalent
to a listed impairment if it is at least equal in severity and duration
to the criteria of any listed impairment, including those listed in
5.00 and 105.00 (Digestive Disorders).\47\
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\42\ Taber's Cyclopedic Medical Dictionary--23rd Ed. (2017).
\43\ Gladwin, M.T., & Levine, A.R. (2020, September).
Hepatopulmonary syndrome. The Merck Manual Professional Version.
<a href="https://www.merckmanuals.com/professional/pulmonary-disorders/pulmonary-hypertension/hepatopulmonary-syndrome">https://www.merckmanuals.com/professional/pulmonary-disorders/pulmonary-hypertension/hepatopulmonary-syndrome</a>.
\44\ Taber's Cyclopedic Medical Dictionary--23rd Ed. (2017).
\45\ Rodr[iacute]guez-Roisin, R., & Krowka, M.J. (1998).
Hepatopulmonary syndrome--a liver-induced lung vascular disorder.
The New England Journal of Medicine, 358, 2378-2387. <a href="https://doi.org/10.1056/NEJMra0707185">https://doi.org/10.1056/NEJMra0707185</a>.
\46\ Grilo-Bensusan, I., & Pascasio-Acevedo, J.M. (2016).
Hepatopulmonary syndrome: What we know and what we would like to
know. World Journal of Gastroenterology, 22(25), 5728-5741. <a href="https://doi.org/10.3748/wjg.v22.i25.5728">https://doi.org/10.3748/wjg.v22.i25.5728</a>.
\47\ 20 CFR 404.1526 and 416.926.
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Comment: One commenter suggested we remove proposed criterion
5.05E2 (``Intrapulmonary arteriovenous shunting'') as it demonstrates
only the presence of hepatopulmonary syndrome and not a level of
hypoxemia or severity associated with proposed 5.05E1 (``Arterial PaO2
measured by an ABG test''). The commenter stated that it is not clear
that arteriovenous shunting as shown by the contrasted echocardiogram
or macroaggregated albumin lung scan required in proposed criterion
5.05E2 (``Intrapulmonary arteriovenous shunting'') necessarily equates
to the expected severity associated with the required hypoxemia levels
in proposed criterion 5.05E1 (``Arterial P<INF>a</INF>O<INF>2</INF>
measured by an ABG test''). The commenter noted that some of these
tests in proposed 5.05E2 (``Intrapulmonary arteriovenous shunting'')
are not quantitative, and not all of them are specific for
intrapulmonary shunting. The commenter asked us to add these tests to
the introductory text along with the symptoms of platypnea (shortness
of breath relieved when lying down) and orthodeoxia (low arterial blood
oxygen in the upright position) that are highly specific for
hepatopulmonary syndrome when present alongside chronic liver disease.
Response: We partially adopted the comment. We updated the
introductory text at 5.00C2e and 105.00C2e (Hepatopulmonary syndrome)
to include the clinical findings suggested by the commenter. While we
agree with the commenter that the criteria in 5.05E2 and 105.05E2
demonstrate the presence of hepatopulmonary syndrome and not a level of
hypoxemia, we kept the criterion because the presence of
hepatopulmonary syndrome, as confirmed by these tests, continues to be
indicative of listing-level severity. Hepatopulmonary syndrome is a
very serious consequence of chronic liver disease, is a progressive
condition, and has a high morbidity and mortality rate associated with
it.\48\ Currently, the only treatment is a liver transplant.\49\
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\48\ SSA has designated hepatopulmonary syndrome as a
Compassionate Allowance (CAL) condition. See Compassionate
Allowances website Home Page (<a href="http://ssa.gov">ssa.gov</a>).
\49\ Bansal, K., Gore, M., & Mittal, S. (2022). Hepatopulmonary
Syndrome. In StatPearls. StatPearls Publishing. <a href="https://www.ncbi.nlm.nih.gov/books/NBK562169">https://www.ncbi.nlm.nih.gov/books/NBK562169</a>.
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Inflammatory Bowel Disease
Comment: A number of commenters questioned why ``perineal disease''
was removed from the list of signs and symptoms of inflammatory bowel
disease (IBD) in proposed 5.00D2 (``We evaluate your signs and symptoms
of IBD'') and urged its inclusion in the final rule.
Response: We adopted this comment. We agree that this is an
important complication of IBD; however, the medical community uses the
term perianal disease to describe the perianal complications that are
considered an early sign of IBD.\50\ So, we adopted the commenter's
suggestion, and changed the terminology to ``perianal disease.'' We
added this to the list of signs and symptoms of IBD in the introductory
text at 5.00D2 and 105.00D2 (``We evaluate your signs and symptoms of
IBD''), and provided examples (``for example, fissure, fistulas,
abscesses, and anal canal stenosis'') associated with perianal Crohn's
disease.
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\50\ Galandiuk, S., Kimberling, J., Al-Mishlab, T.G., &
Stromberg, A.J. (2005). Perianal Crohn disease: Predictors of need
for permanent diversion. Annals of surgery, 241(5), 796-802. <a href="https://doi.org/10.1097/01.sla.0000161030.25860.c1">https://doi.org/10.1097/01.sla.0000161030.25860.c1</a>.
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Comment: Commenters recommended that the final version of the
listing include the language from current 5.00E3 (``IBD may be
associated with significant extraintestinal manifestations in a variety
of body systems'') about extraintestinal manifestations of IBD.
Response: We agree with the commenter and added the language from
current paragraph 5.00E3 (``IBD may be associated with significant
extraintestinal manifestations in a variety of body systems'') about
extraintestinal manifestations of IBD to paragraph 5.00D4 (``IBD may
also be associated with significant extraintestinal manifestations in a
variety of body systems''). For consistency between adult and child
listings, we also added the corresponding language from current
paragraph 105.00E3 (``IBD may be associated with significant
extraintestinal manifestations in a variety of body systems'') as
revised
[[Page 37721]]
paragraph 105.00D4 (``IBD may be associated with significant
extraintestinal manifestations in a variety of body systems''), and
renumbered proposed paragraph 105.00D4 as revised paragraph 105.00D5.
Comment: One commenter recommended that the tube feeding
description be expanded beyond ``gastric'' to other types (that is,
duodenal or jejunal) that are often required in patients with digestive
disorders.
Response: We adopted this comment because the commenter brought a
perspective that we had not considered, which was that types of tube
feeding which are similar in purpose should be included in the listing,
and our research confirmed that supplemental daily enteral nutrition
supplied via duodenostomy or jejunostomy is also representative of
listing-level severity.<SUP>51 52 53</SUP> Therefore, we added tube
feeding via duodenostomy or jejunostomy to listings 5.06B and 105.06B
(``Two of the following occurring within a consecutive 12-month
period''), and 105.10 (Need for supplemental daily enteral feeding via
a gastrostomy, duodenostomy, or jejunostomy). We also provided guidance
about evaluating tube feedings in introductory text sections 5.00D2 and
105.00D2 (``We evaluate your signs and symptoms of IBD'') and 105.00H
(How do we evaluate the need for supplemental daily enteral feeding via
a gastrostomy, duodenostomy, or jejunostomy?).
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\51\ Pearce, C.B. & Duncan, H.D. (2002). Enteral feeding.
Nasogastric, nasojejunal, percutaneous endoscopic gastrostomy, or
jejunostomy: its indications and limitations, Postgraduate Medical
Journal, 78, 198-204. <a href="https://doi.10.1136/pmj.78.918.198">https://doi.10.1136/pmj.78.918.198</a>.
\52\ Brett, K. & Arg[aacute]ez, C. (2018). Gastrostomy versus
gastrojejunostomy and/or jejunostomy feeding tubes: a review of
clinical effectiveness, cost-effectiveness and guidelines. Ottawa
(ON): Canadian Agency for Drugs and Technologies in Health.
\53\ Clinical Nutrition University. (2021, May 25). Types of
Feeding Tubes EXPLAINED. YouTube. <a href="https://www.youtube.com/watch?v=4Oam1yUHiO8">https://www.youtube.com/watch?v=4Oam1yUHiO8</a>.
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Short Bowel Syndrome and Intestinal Failure
Comment: One commenter agreed with the proposed changes to expand
the definition of short bowel syndrome (SBS) to consider ``surgical
resection of any amount of the small intestine,'' but suggested we
further expand the definition by adding ``the continual need for
nutritional intervention such as oral rehydration, enteral tube feeding
and/or parenteral nutrition is documented.''
Response: We did not adopt the comment. The listings describe
impairments that we consider severe enough to prevent an adult from
doing any gainful activity.\54\ The commenter's suggestion includes
oral rehydration and enteral tube feeding, which, when associated with
SBS or intestinal failure, are not indicative of a condition that is
listing-level severity.\55\ Since, on their own, these nutritional
interventions are not dispositive of a disorder that is severe enough
to prevent any gainful activity, we did not expand the definition of
SBS as the commenter suggested. However, we do consider evidence of
nutritional intervention alongside all other relevant information at
later steps in our sequential evaluation process.
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\54\ 20 CFR 404.1525(a) and 416.925(a).
\55\ Nightingale, J. & Woodward, J.M. (2006). Guidelines for
management of patients with a short bowel. Gut, 55(Suppl IV), iv1-
iv12. <a href="https://doi.10.1136/gut.2006.091108">https://doi.10.1136/gut.2006.091108</a>.
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Comment: One commenter asked us to expand the criteria for listings
5.07 and 105.07 (Intestinal failure) to ``support patients who are not
completely dependent on parenteral nutrition, but who will experience
better quality of life if it is supplementary in some form.''
Response: We did not adopt this comment. The statutory definition
of disability concerns a person's ability to do work, not on quality of
life.\56\ The commenter described alternative, less burdensome,
treatment options that assist patients with achieving independence, but
these alternatives, on their own, are not indicative of listing-level
severity. The listings are designed to identify cases at an early stage
of the sequential evaluation process that meet a strict threshold for
the statutory definition of disability. They describe impairments that
we consider severe enough to prevent an adult from doing any gainful
activity.\57\ For children, the listings describe impairments we
consider severe enough to cause marked and severe functional
limitations.\58\ If an impairment does not meet a listing, this does
not mean that we will deny a claim. If an adult's impairment(s) does
not meet or medically equal any listing, we may find that person
disabled at a later step in the sequential evaluation process.\59\ If a
child's impairment(s) does not meet or medically equal any listing, we
may find that their impairment(s) functionally equal the listings.\60\
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\56\ 42 U.S.C. 416(i) and 423(d).
\57\ 20 CFR 404.1525(a) and 416.925(a).
\58\ 20 CFR 416.925(a).
\59\ 20 CFR 404.1520 and 416.920.
\60\ 20 CFR 416.924.
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Comment: One commenter suggested we revise the listings for SBS
(5.07 and 105.07) or add a new listing to more broadly address
intestinal failure with need for parenteral nutrition. They suggested
that for children with impaired or absent intestinal motility from an
increasing number of congenital and acquired conditions, the same
impairments exist without the surgery requirement as with SBS (for
example, gastroschisis, omphalocele, long segment Hirschprung's, and
increasingly recognized disorders of mitochondria and other cellular
functions that severely impair intestinal functioning).
Response: We adopted this comment. Our intent in the proposed
expanded listings for SBS was to include individuals whose medical
records do not contain documentation of resection of more than one-half
of the small intestine, but whose loss of intestinal function is so
severe that daily parenteral nutrition is needed to maintain health.
Along these lines, the commenters brought a perspective that we had not
considered when they suggested the inclusion of other similar
intestinal conditions that could cause intestinal failure with the same
degree of impairment of gut function, but in the absence of SBS. When
we considered these comments, we accepted them, because the research
cited in the comments as well as our own supplemental research and
review of cases confirmed that other common causes of chronic
intestinal failure--specifically, extensive small bowel mucosal disease
and chronic motility disorders--can similarly impair intestinal
function and prevent absorption of macronutrients or water and
electrolytes below that necessary to
[[Page 37722]]
maintain life, also requiring daily parenteral
nutrition.<SUP>61 62 63 64 65</SUP> Therefore, we expanded and renamed
listings 5.07 and 105.07 Intestinal failure to cover a greater range of
chronic dysmotility or absent motility disorders lasting or expected to
last at least 12 months and reducing gut function below the minimum
necessary for the absorption of macronutrients or water and
electrolytes sufficient for health, as we explain in the introductory
text in 5.00E1 and 105.00E1 (What is intestinal failure, and how do we
evaluate it under 5.07/105.07?).
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\61\ Thompson JS, Rochling FA, Weseman RA, Mercer DF. Current
management of short bowel syndrome. Curr Probl Surg 49:52-115, 2012.
<a href="https://doi.org/10.1067/j.cpsurg.2011.10.002">https://doi.org/10.1067/j.cpsurg.2011.10.002</a>.
\62\ Pironi, L., Arends, J., Baxter, J., Bozzetti, F.,
Pel[aacute]ez, R.B., Cuerda, C., Forbes, A., Gabe, S., Gillanders,
L., Holst, M., Jeppesen, P.B., Joly, F., Kelly, D., Klek, S., Irtun,
[Oslash]., Olde Damink, S.W., Panisic, M., Rasmussen, H.H., Staun,
M., Szczepanek, K., . . . Acute Intestinal Failure Special Interest
Groups of ESPEN (2015). ESPEN endorsed recommendations. Definition
and classification of intestinal failure in adults. Clinical
nutrition (Edinburgh, Scotland), 34(2), 171-180. <a href="https://doi.org/10.1016/j.clnu.2014.08.017">https://doi.org/10.1016/j.clnu.2014.08.017</a>.
\63\ Pironi, L., Arends, J., Bozzetti, F., Cuerda, C.,
Gillanders, L., Jeppesen, P.B., Joly, F., Kelly, D., Lal, S., Staun,
M., Szczepanek, K., Van Gossum, A., Wanten, G., Schneider, S.M., &
Home Artificial Nutrition & Chronic Intestinal Failure Special
Interest Group of ESPEN (2016). ESPEN guidelines on chronic
intestinal failure in adults. Clinical nutrition (Edinburgh,
Scotland), 35(2), 247-307. <a href="https://doi.org/10.1016/j.clnu.2016.01.020">https://doi.org/10.1016/j.clnu.2016.01.020</a>.
\64\ Deutsch, L., Cloutier, A., & Lal, S. (2020). Advances in
chronic intestinal failure management and therapies. Current opinion
in gastroenterology, 36(3), 223-229. <a href="https://doi.org/10.1097/MOG.0000000000000631">https://doi.org/10.1097/MOG.0000000000000631</a>.
\65\ Pierret, A., Wilkinson, J.T., Zilbauer, M., & Mann, J.P.
(2019). Clinical outcomes in pediatric intestinal failure: a meta-
analysis and meta-regression. The American journal of clinical
nutrition, 110(2), 430-436. <a href="https://doi.org/10.1093/ajcn/nqz110">https://doi.org/10.1093/ajcn/nqz110</a>.
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Malnutrition
Comment: A number of commenters expressed concern about and
suggestions for our proposed criteria for malnutrition in listing 5.08
(Weight loss due to any digestive disorder), particularly the use of
laboratory values such as hemoglobin or albumin. Commenters also
suggested we remove the requirement that malnutrition be caused by a
digestive disorder. However, these commenters supported our proposed
change to the period over which the criteria must appear in the medical
evidence of record for listing 5.08 (Weight loss due to any digestive
disorder), as well as multiple other digestive listings, from a period
of 6 months to a period of 12 months.
Response: We carefully considered all of the concerns raised by the
commenters and concluded that we should not finalize our proposed
changes to add measurements of hemoglobin and albumin to this listing.
Intending to improve the specificity of the listing, we had proposed
these biomarkers in congruence with using the term ``malnutrition''
instead of ``weight loss'' along with proposing that weight loss be the
result of malnutrition caused by a digestive disorder. We reviewed the
comments and research supporting the comments <SUP>66 67</SUP>
suggesting that these measurements are not the best indicators of
listing-level weight loss in adults and we ultimately agreed with the
commenters that malnutrition caused by a digestive disorder does not
have a strong enough relationship with those biomarkers to include them
in the listing. That is, these biomarkers are not specific to
malnutrition and can instead be indicative of other conditions such as
cancers, autoimmune disorders, bleeding, and cardiovascular
diseases.<SUP>68 69</SUP> We concluded that there are not currently
biomarkers or other clinical evidence that are both regularly available
in medical records and highly specific to severe, listing-level
malnutrition. Therefore, after consultation with agency medical experts
and reviewing research provided by one of the commenters, we determined
that the BMI remains the most specific and readily available
documentation of digestive disorders that have caused weight loss so
severe that it prevents any gainful activity, and we will retain the
current body mass index (BMI) criteria in listing 5.08 (Weight loss due
to any digestive disorder).
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\66\ Becker, P., Carney, L.N., Corkins, M.R., Monczka, J.,
Smith, E., Smith, S.E., Spear, B.A., & White, J.V. (2015). Consensus
statement of the Academy of Nutrition and Dietetics/American Society
for Parenteral and Enteral Nutrition: Indicators recommended for the
identification and documentation of pediatric malnutrition
(undernutrition). Nutrition in Clinical Practice, 30(1), 147-161.
<a href="https://doi.org/10.1177/0884533614557642">https://doi.org/10.1177/0884533614557642</a>.
\67\ White, J.V., Guenter, P., Jensen, G., Malone, A., &
Schofield, M. (2012). Consensus statement: Academy of Nutrition and
Dietetics and American Society for Parenteral and Enteral Nutrition:
Characteristics recommended for the identification and documentation
of adult malnutrition (undernutrition). Journal of Parenteral and
Enteral Nutrition, 36(3), 275-283. <a href="https://doi.org/10.1177/0148607112440285">https://doi.org/10.1177/0148607112440285</a>.
\68\ Gounden, V., Vashisht, R., & Jialal, I. (2021).
Hypoalbuminemia. In StatPearls [internet]. StatPearls Publishing.
<a href="https://www.ncbi.nlm.nih.gov/books/NBK526080/">https://www.ncbi.nlm.nih.gov/books/NBK526080/</a>.
\69\ National Heart Lung and Blood Institute. (2011). Your guide
to anemia (NIH Publication No. 11-7629). US Department of Health and
Human Services, National Institutes of Health. <a href="https://www.nhlbi.nih.gov/files/docs/public/blood/anemia-yg.pdf">https://www.nhlbi.nih.gov/files/docs/public/blood/anemia-yg.pdf</a>.
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Likewise, consistent with the comments supporting the change from 6
months to 12 months, we kept the proposed revision in the final
language for listing 5.08 (Weight loss due to any digestive disorder)
to require the two BMI calculations to be within a consecutive 12-month
period. We made the appropriate related changes to the introductory
text, including 5.00A (Which digestive disorders do we evaluate in this
body system?), 5.00D (What is inflammatory bowel disease (IBD), and how
do we evaluate it under 5.06?), and 5.00F (How do we evaluate weight
loss due to any digestive disorder under 5.08?).
Because we are not finalizing our proposal to use laboratory values
such as hemoglobin or albumin in listing 5.08, we also retained current
5.06B1 (``Anemia'') and 5.06B2 (``Serum albumin''). We proposed to
remove them due to redundancy with the proposed criteria for 5.08
(Weight loss due to any digestive disorder). We also retained current
5.00E4 and 105.00E4 (``Surgical diversion of the intestinal tract'') as
5.00D3 and 105.00D3.
We did not adopt the suggestion to omit the words ``due to any
digestive disorder'' from listing 5.08 because we define digestive
disorders in 5.00A (Which digestive disorders do we evaluate in this
body system?) as disorders ``that result in severe dysfunction of the
liver, pancreas, and gastrointestinal tract.''
Comment: One commenter expressed concern about the proposed change
to listings 5.08 (Weight loss due to any digestive disorder) and 105.08
(Growth failure due to any digestive disorder) from a 6-month period
for the two data points (two BMI calculations) to a 12-month period,
because of the detrimental effects of malnutrition over time.
Response: We did not adopt the comment, because the commenter's
remarks seem to indicate a misunderstanding of our proposal. The
commenter seems to believe that the two data points must be taken 12
months apart, but we did not propose a requirement that the two data
points be taken 12 months apart. Our proposed requirement, finalized in
this final rule, specifies that the two measurements must both be taken
during a 12-month period and must be at least 60 days apart from one
another during the 12-month period.
Comment: One commenter asked that we consider a higher BMI
criterion, such as 20 or 22, for elderly patients under proposed
listing 5.08 (Weight loss due to any digestive disorder).
Response: We did not adopt this comment. We do not adjust BMI
calculations based on an adult person's
[[Page 37723]]
age.\70\ The disability program rules, including the listings, end at
full retirement age. If the person has not yet reached full retirement
age, we will consider age at a later step in the sequential evaluation
process, when we consider the person's residual functional capacity,
age, education, and work experience.\71\
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\70\ Center for Disease Control. <a href="https://www.cdc.gov/healthyweight/assessing/bmi/adult_bmi/index.html">https://www.cdc.gov/healthyweight/assessing/bmi/adult_bmi/index.html</a>. The CDC does not
alter BMI calculations for adults 20 years and older.
\71\ 20 CFR 404.1520 and 416.920.
---------------------------------------------------------------------------
Comment: One commenter stated that listing 5.08 (Weight loss due to
any digestive disorder) does not specifically address eating disorders.
The commenter asked us to add language to the preamble (listing
introductory text) to clarify that adjudicators should utilize listing
12.13 (Eating disorders) to address eating disorders in listing 5.08
(Weight loss due to any digestive disorder).
Response: We adopted this comment. Listing 5.08 (Weight loss due to
any digestive disorder) is used to evaluate digestive disorders that
result in significant or serious weight loss. We define digestive
disorders in 5.00A (Which digestive disorders do we evaluate in this
body system?) as disorders ``that result in severe dysfunction of the
liver, pancreas, and gastrointestinal tract.'' However, severe,
listing-level weight loss can occur as a result of impairments other
than digestive disorders, such as due to certain genitourinary, immune,
or mental disorders. We have added language to the introductory text in
5.00F (How do we evaluate weight loss due to any digestive disorder
under 5.08?) and 105.00F (How do we evaluate growth failure due to any
digestive disorder under 105.08?) to provide adjudicators with guidance
on how to evaluate weight loss not caused by a digestive disorder.
Specifically, we explain that impairments other than digestive
disorders that cause weight loss should be evaluated under the
appropriate body system for that impairment. If the claimant develops a
digestive disorder as the result of another impairment, we will
evaluate the acquired digestive disorder under our rules for digestive
disorders.
Comment: One commenter recommended that malnutrition be included as
a causative factor for each of the digestive disorders, because it
results in functional impairments.
Response: We did not adopt this comment. We disagree with the
commenter's assertion that malnutrition is a causative factor for each
of the digestive disorders. For example, while increased malnutrition
risk is associated with IBD, it is not thought to cause
IBD.<SUP>72 73</SUP>
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\72\ Schreiner, P., Martinho-Grueber, M., Studerus, D.,
Vavricka, S.R., Tilg, H., & Biedermann, L. (2020). Nutrition in
inflammatory bowel disease. Digestion, 101(Suppl. 1), 120-135.
<a href="https://doi.org/10.1159/000505368">https://doi.org/10.1159/000505368</a>.
\73\ Ramos, G.P., & Papadakis, K.A. (2019). Mechanisms of
disease: Inflammatory bowel diseases. Mayo Clinic Proceedings,
94(1), 155-165. <a href="https://doi.org/10.1016/j.mayocp.2018.09.013">https://doi.org/10.1016/j.mayocp.2018.09.013</a>.
---------------------------------------------------------------------------
Growth Failure
Comment: One commenter suggested that we define growth failure as
weight-for-height/length or BMI z-scores less than 2. Another commenter
requested that we use z-scores for single data points in listing 105.08
(Growth failure due to any digestive disorder). The commenter
recommended a z-score of <-1 for weight-for-height, BMI-for-age,
length/height for age, or mid-arm muscle circumference defining risk of
malnutrition and multiple z-score measurements over time demonstrating
a deceleration of weight for length/height diagnosing malnutrition. The
commenter also proposed looking at weight gain velocity, weight loss,
or inadequate nutrient intake to diagnose malnutrition.
Response: We did not adopt these comments. We did not propose to
change the requirements in listing 105.08 (Growth failure due to any
digestive disorder). Our long-standing policy is to use the third
percentile, going back to the inception of listing 105.08 (Growth
failure due to any digestive disorder) in 1977.\74\ As we explained in
the 2001 NPRM on which the current criteria are based, ``[t]he 3rd
percentile is generally accepted as the lower limit of the normal range
for most biologic measurements.'' \75\ A child whose weight is in the
3rd percentile weighs the same or more than 3 percent of the reference
population, and weighs less than 97 percent of the children in the
reference population. Percentiles are commonly used to assess the
growth of children in the United States. We are continuing our policy
that measurements below the third percentile correspond to listing-
level severity for children because the Centers for Disease Control and
Prevention (CDC) growth tables continues to provide percentiles.\76\
The tables included in 105.08 (Growth failure due to any digestive
disorder) are equivalent \77\ to the CDC growth tables.\78\ In the
development of these tables, the CDC elected to use the third
percentile as approximate to a z-score of -2, which is a standard
statistical cutoff point to determine the need for nutritional
intervention.\79\ The CDC explained that ``[p]ercentiles are the most
commonly used clinical indicator to assess the size and growth patterns
of individual children in the United States.'' \80\ The third
percentile on the CDC charts identifies the extremes of the
distribution and is referenced by pediatric endocrinologists and others
who assess the growth of children with special health care
requirements.\81\ The childhood listings describe impairments that
cause marked and severe functional limitations.\82\ Listing 105.08
(Growth failure due to any digestive disorder) specifically describes
growth failure due to a digestive disorder (such as malnutrition) that
is severe enough to meet this threshold. Listing 105.08 (Growth failure
due to any digestive disorder) is not intended to provide diagnostic
guidelines for such a disorder generally, or to help identify children
who may be at risk of a disorder.
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\74\ 42 FR 14705, 14710 (1977).
\75\ 66 FR 57009, 57014 (2001).
\76\ 66 FR at 57021 (2001).
\77\ The values in our table are generally the same as those
used by the CDC, but we have rounded to the nearest tenth and
grouped same values into a single line on our table. For example:
Row 1 on the CDC table for boys age 2 is 14.50347667 and row 2 for
boys age 2.1 is 14.46882381. Both of these values round to 14.5, so
on the SSA table the value of 14.5 is given for boys age 2-2.1.
Furthermore, although the CDC table goes to age 20 for boys, we do
not use the values for age 18-20, because we do not use the
childhood listings for individuals 18 and older.
\78\ National Center for Health Studies. (2002, May). 2000 CDC
Growth Charts for the United States: Methods and Development. United
States Department of Health & Human Services <a href="https://www.cdc.gov/nchs/data/series/sr_11/sr11_246.pdf">https://www.cdc.gov/nchs/data/series/sr_11/sr11_246.pdf</a>.
\79\ Id.
\80\ Id.
\81\ National Center for Health Studies. (2017, June). Clinical
Growth Charts. Centers for Disease Control and Prevention. <a href="https://www.cdc.gov/growthcharts/clinical_charts.htm">https://www.cdc.gov/growthcharts/clinical_charts.htm</a>.
\82\ 20 CFR 416.925.
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Comment: One commenter stated that we did not provide adequate
justification for our selection of using the 3rd percentile values for
weight-for length and our selection of albumin and hemoglobin levels in
listing 105.08 (Growth failure due to any digestive disorder).
Response: The comment reflects a misunderstanding since we did not
propose to change the requirements in listing 105.08 (Growth failure
due to any digestive disorder). The text in this section of the listing
is unchanged, and identical to our existing regulatory text, but we
chose to republish it for the clarity and continuity of the listing as
a whole.
[[Page 37724]]
Other Digestive Disorders Comments
Comment: One commenter asked if we considered expanding the one-
year period for which we consider a person to be under a disability
following liver (5.09, 105.09 (Liver transplantation)), small intestine
(5.11, 105.11 (Small intestine transplantation)), or pancreas (5.12,
105.12 (Pancreas transplantation)) transplant, because post-transplant
follow-up, complications, or adverse effects of immunosuppression may
persist for longer than a year.
Response: We considered this comment and are not making any
changes. The one-year period of disability following liver, small
intestine, or pancreas transplant in these listings is consistent with
the listings for heart transplant (4.09 (Heart transplant)) and kidney
transplant (6.04 (Chronic kidney disease, with kidney transplant)).
Like other organ transplant recipients, liver transplant recipients are
at risk of developing post-transplant complications such as organ
rejection or infection. The risk of rejection is highest during the
first 3-6 months after transplantation and then decreases
significantly.\83\ Bacterial infections are most common within the
first month and viral infections generally occur within the first 6
months.\84\ Medical literature for liver transplant recipients
indicates that most transplant recipients are able to return to
activities of daily living and work within 12 months.\85\
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\83\ Manzarbeitia, C., & Arvelakis, A. (2019, January 11). Liver
transplantation treatment & management. Medscape. <a href="https://emedicine.medscape.com/article/431783-treatment">https://emedicine.medscape.com/article/431783-treatment</a>.
\84\ Roayaie, K., & Feng, S. Liver transplant. University of
California San Francisco Transplant Surgery Department of Surgery.
<a href="https://transplantsurgery.ucsf.edu/conditions--procedures/liver-transplant.aspx">https://transplantsurgery.ucsf.edu/conditions--procedures/liver-transplant.aspx</a>.
\85\ Mayo Clinic Staff. (2020, July 15). Liver transplant. Mayo
Clinic. <a href="https://www.mayoclinic.org/tests-procedures/liver-transplant/about/pac-20384842">https://www.mayoclinic.org/tests-procedures/liver-transplant/about/pac-20384842</a>.
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We reevaluate the claim at the end of the one-year period, using
updated medical records and any other necessary information to
determine if there is continuing disability.\86\ Additionally, we do
not automatically cease benefits once the one-year period has
concluded. As we explain in 5.00G and 105.00G (How do we evaluate
digestive organ transplantation?), after the one-year period, we
evaluate the person's post-transplant function, the frequency and
severity of any rejection episodes, complications in other body
systems, and adverse treatment effects. A continuation or cessation of
disability depends on the evidence found in the medical record at the
time of reevaluation.\87\
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\86\ See 5.00G and 105.00G (How do we evaluate digestive organ
transplantation?).
\87\ 20 CFR 404.1589 and 416.989.
---------------------------------------------------------------------------
Comment: One commenter suggested that we revise listing 105.10
(Need for supplemental daily enteral feeding via a gastrostomy) ``to
include tube feeding by nasogastric or nasojejunal tube feeding, or
gastrojejunostomy, as well as by gastrostomy.''
Response: We partially adopted this comment. We revised listing
105.10 (Need for supplemental daily enteral feeding via a gastrostomy)
to include tube feeding by jejunostomy or duodenostomy, as well as by
gastrostomy. We did not include nasogastric or nasojejunal tube
feeding. Nasogastric or nasojejunal tube feeding methods are likely to
be used for relatively short periods of time and would not meet the
durational requirement for disability.<SUP>88 89</SUP> We also updated
the introductory text at 105.00H (How do we evaluate the need for
supplemental daily enteral feeding via a gastrostomy, duodenostomy, or
jejunostomy?) to reflect this additional language.
---------------------------------------------------------------------------
\88\ Yi, D.Y. (2018). Enteral nutrition in pediatric patients.
Pediatric Gastroenterology, Hepatology, & Nutrition, 21(1), 12-19.
<a href="https://doi.org/10.5223/pghn.2018.21.1.12">https://doi.org/10.5223/pghn.2018.21.1.12</a>.
\89\ 20 CFR 416.906 and 416.909.
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Comment: One commenter asked that we ``clarify how pancreatic
disease would be identified since it is not included as a separate
listing.''
Response: We did not make any changes to this rule based on this
comment. We do not have a listing for every digestive disorder.
However, we evaluate unlisted digestive disorders under the sequential
evaluation process, as we explain in 5.00J and 105.00L (How do we
evaluate digestive disorders that do not meet one of these listings?).
We will first consider whether an impairment, such as pancreatic
disease, medically equals a listing. If the impairment(s) does not
medically equal the criteria of a listing, this does not mean that we
will deny the claim. If an adult's impairment(s) does not meet or
medically equal any listing, we may find that person disabled at a
later step in the sequential evaluation process.\90\ If a child's
impairment(s) does not meet or medically equal any listing, we may find
that their impairment(s) functionally equal the listings.\91\
---------------------------------------------------------------------------
\90\ 20 CFR 404.1520 and 416.920.
\91\ 20 CFR 416.924.
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Comment: Several commenters asked us to add that a lack of opioid
or narcotic prescriptions or attempts to reduce or avoid use of such
medication should never be considered indicative of the severity of an
impairment, nor should it affect an adjudicator's decision about
whether an impairment can reasonably be expected to produce a person's
symptoms (including pain) or about the intensity and severity of such
symptoms.
Response: We did not adopt these comments. The disability program
rules require the presence of a medically determinable impairment that
can reasonably be expected to produce the symptoms (including pain).
Our adjudicators consider all evidence in the record when making this
finding, including a description of the person's medications and the
effects of those medications on the allegations of pain, as well as
factors such as the person's daily activities, the location, duration,
frequency, and intensity of their symptoms, treatment other than
medication, and any measures other than treatment that the person uses
to alleviate their symptoms, such as the need to change positions.\92\
If a person is prescribed any medication, including opioid or other
narcotic medication, and chooses to not take the medication, we use our
rules regarding the need to follow prescribed treatment, which apply to
all medical conditions, not just digestive disorders, and are explained
in 20 CFR 404.1530 and 416.930 (Need to follow prescribed treatment).
In conjunction with our regulations, we provide additional guidance on
following prescribed treatment in SSR 18-3p (Titles II and XVI: Failure
to Follow Prescribed Treatment), in which we include the ``risk of
addiction to opioid medication'' as an example of a ``good cause''
reason for not following prescribed treatment.'' \93\ As such, it is
already our policy that a lack of, or reduction of, opioid or narcotic
prescriptions due to the risk of addiction will not adversely affect a
person's claim during the adjudication process. Consequently, there is
no need to specify such within this specific medical listing.
---------------------------------------------------------------------------
\92\ 20 CFR 404.1529(c)(3), 416.929(c)(3), and Social Security
Ruling (SSR) 16-3p (2016). Available at: <a href="https://www.ssa.gov/OP_Home/rulings/di/01/SSR2016-03-di-01.html">https://www.ssa.gov/OP_Home/rulings/di/01/SSR2016-03-di-01.html</a>.
\93\ SSR 18-3p (2018). Available at: <a href="https://www.ssa.gov/OP_Home/rulings/di/02/SSR2018-03-di-02.html">https://www.ssa.gov/OP_Home/rulings/di/02/SSR2018-03-di-02.html</a>.
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Comment: One commenter stated that we failed to provide evidence
that we considered the tolerance of employers when dealing with the
issues associated with digestive disorders (for example, diarrhea,
fecal incontinence, rectal bleeding, abdominal pain, fatigue, fever,
nausea, vomiting, and arthralgia).
Response: We did not make changes in response to the comment,
because we follow our statutory requirements. The
[[Page 37725]]
Act states a person shall be determined to be under a disability only
if the person is unable to do any substantial gainful activity,
regardless of whether an employer would hire them.\94\ The listings,
however, identify impairments we consider severe enough to prevent a
person from doing any gainful activity, regardless of the person's age,
education, or work experience.\95\ Consistent with the Act, we do not
consider whether employers may be unwilling to hire a person with a
particular impairment, such as a digestive disorder. Individual,
employer-specific policies vary in scope and so are not appropriate for
our national program, which uses a definition of disability that can be
uniformly applied throughout the nation. We will consider the effects
of an individual's resulting symptoms from their medically determinable
digestive disorders, such as those identified by the commenter when we
assess and consider the individual's residual functional capacity at
later steps in our sequential evaluation process.\96\
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\94\ 42 U.S.C. 423(d)(2)(A) and 42 U.S.C. 1382c(a)(3)(B).
\95\ 20 CFR 404.1525 and 20 CFR 416.925.
\96\ 20 CFR 404.1520 and 20 CFR 416.920.
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Skin Disorders
Comment: Several commenters asked that we add wheeled mobility
devices, specifically wheelchairs, adaptive or special needs strollers,
and scooters, to our definition of ``assistive device(s)'' in 8.00B1
and 108.00B1 (Assistive device(s)).\97\ The commenters also noted that
while the wheeled mobility devices they requested are not hand-held or
worn, they improve stability and mobility, and stated claimants with a
documented medical need for these devices have functional limitations
at least as significant to those with a need for other assistive
devices.
---------------------------------------------------------------------------
\97\ We note that the commenters referenced 8.00B2 and 108.00B2
(Chronic skin lesions), which is not correct. The correct reference
for the definition of ``assistive device(s)'' for this comment is
8.00B1 and 108.00B1 (Assistive device(s)).
---------------------------------------------------------------------------
Response: We generally adopted these comments, specifying
alternative examples. We incorporated devices used in a seated position
into the definition of assistive device(s) in 8.00B1 and 108.00B1
(Assistive device(s)). Rather than using the suggested examples of
``wheelchairs, adaptive or special needs strollers, and scooters,'' we
used examples such as wheelchair, rollator, and power operated vehicle.
We chose these examples because the National Academies of Sciences,
Engineering, and Medicine described these types of wheeled and seated
mobility devices in a consensus study report on assistive
technology.\98\ This change is also consistent with the definition of
``assistive device(s)'' used in the recently published final rule,
Revised Medical Criteria for Evaluating Musculoskeletal Disorders.\99\
---------------------------------------------------------------------------
\98\ National Academies of Sciences, Engineering, and Medicine.
(2017). The promise of assistive technology to enhance activity and
work participation. The National Academies Press. <a href="https://doi.org/10.17226/24740">https://doi.org/10.17226/24740</a>.
\99\ 85 FR 78164 (2020).
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Comment: Several commenters stated that the definition of ``fine
and gross movements'' in 8.00B5 and 108.00B5 (Fine and gross movements)
should include ``feeling'' as a fine movement, in keeping with SSR 85-
15 (Titles II and XVI: Capability to Do Other Work--The Medical-
Vocational Rules as a Framework for Evaluating Solely Nonexertional
Impairments.) \100\ In addition, a commenter also referenced SSR 09-6p
(Title XVI: Determining Childhood Disability--The Functional
Equivalence Domain of ``Moving About and Manipulating Objects.'') \101\
---------------------------------------------------------------------------
\100\ SSR 85-15 (1985). Available at: <a href="https://www.ssa.gov/OP_Home/rulings/di/02/SSR85-15-di-02.html">https://www.ssa.gov/OP_Home/rulings/di/02/SSR85-15-di-02.html</a>.
\101\ SSR 09-6p (2009). Available at: <a href="https://www.ssa.gov/OP_Home/rulings/ssi/02/SSR2009-06-ssi-02.html">https://www.ssa.gov/OP_Home/rulings/ssi/02/SSR2009-06-ssi-02.html</a>.
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Response: We disagree with the comments and did not adopt the
suggestion. SSR 85-15 (Titles II and XVI: Capability to Do Other Work--
The Medical-Vocational Rules as a Framework for Evaluating Solely
Nonexertional Impairments) provides guidance to our adjudicators on the
capability to do other work, applicable at step 5 of the sequential
evaluation process; it is therefore not within the scope of this final
rule, which addresses the listings step of the sequential evaluation
process. With regard to SSR 09-6p (Title XVI: Determining Childhood
Disability--The Functional Equivalence Domain of ``Moving About and
Manipulating Objects''), this SSR is consolidated guidance for our
adjudicators for evaluating the functional equivalence domain of moving
about and manipulating objects for children, which is also not within
the scope of this final rule. While these SSRs are not within the scope
of this final rule, we note that SSR 09-6p (Title XVI: Determining
Childhood Disability--The Functional Equivalence Domain of ``Moving
About and Manipulating Objects'') does not specifically mention feeling
in regard to fine and gross movements, only that sensory loss that
interferes with motor activities is a limitation we consider under the
domain of ``moving about and manipulating objects.'' Moreover, SSR 85-
15 (Titles II and XVI: Capability to Do Other Work--The Medical-
Vocational Rules as a Framework for Evaluating Solely Nonexertional
Impairments) discusses ``feeling'' as a manipulative impairment, not as
a fine movement as the commenter implies. However, if the claimant's
skin condition causes limitations in their ability to feel, which also
results in significant deficits in their ability to perform fine and
gross movements as defined in 8.00B5 and 108.00B5 (Fine and gross
movements), their skin condition may be found to meet the listing
criteria. If the evidence does not support a finding that the
claimant's skin condition meets a listing, any additional impact of the
claimant's loss of ability to feel due to a skin condition would be
evaluated under our medical equivalence rules (as well as our
functional equivalence rules for child claimants) at step 3 of the
sequential evaluation, or at steps 4 and 5 of the sequential evaluation
process for adult claimants.\102\
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\102\ 20 CFR 404.1545(d) and 416.945(d).
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Comment: Several commenters stated that it was unclear why proposed
sections 8.00C3d and 108.00C3d (What evidence do we need to evaluate
your skin disorder?) require information about the claimant's ``history
of familial incidence'' of a skin impairment.\103\ They asserted that
the information may be unobtainable (for example, family members may be
absent, deceased, not receiving medical treatment, or reluctant to
share medical information), and the history does not affect the
claimant's level of functioning.
---------------------------------------------------------------------------
\103\ 84 FR at 35948, 35956 (2019).
---------------------------------------------------------------------------
Response: Our changes only reorganized the current guidance into an
outline format for easier reading; we did not propose new requirements.
Additionally, our guidance in 8.00B and 108.08B (What documentation do
we need?) applies to the entirety of the skin listings, and as we state
in 8.00A and 108.00A (Which skin disorders do we evaluate under these
listings?) of the current rules, we evaluate skin disorders that result
from hereditary, congenital, or acquired pathological processes.
Therefore, a history of familial incidence, when available, may help us
in evaluating hereditary skin disorders. For example, for many
inherited skin disorders, we consider a family history as key
information in helping establish a medically determinable
[[Page 37726]]
impairment.\104\ Additionally, other conditions, such as atopic
dermatitis, have a high familial occurrence, and therefore a family
history is useful information in establishing the presence of a
medically determinable impairment.\105\ However, for other skin
conditions, including acquired conditions such as burn injuries, a
familial history is less relevant, and we would not seek information on
familial incidence in those cases. Nevertheless, we made minor changes
in response to this comment, and acknowledge some claimants will not
have a history of familial incidence or access to adequate or any
health information about genetic relatives. While familial incidence is
useful, we will use other available information and medical evidence to
establish the medically determinable impairment in instances where it
is not available.
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\104\ Tantcheva-Poor, I., Oji, V., & Has, C. (2016) A multistep
approach to the diagnosis of rare genodermatoses. Journal of the
German Society of Dermatology, 14(10), 969-986. <a href="https://doi.org/10.1111/ddg.13140">https://doi.org/10.1111/ddg.13140</a>.
\105\ DeStefano, G.M., & Christiano, A.M. (2014) The genetics of
human skin disease. Cold Spring Harbor Perspectives in Medicine,
4(10), a015172. <a href="https://doi.org/10.1101/cshperspect.a015172">https://doi.org/10.1101/cshperspect.a015172</a>.
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We modified 8.00C3 and 108.00C3 (What evidence do we need to
evaluate your skin disorder?) and its subparagraphs. In this final
rule, we split the requirements from proposed 8.00C3d and 108.00C3d
(``Your history of familial incidence; exposure to toxins, allergens or
irritants; seasonal variations; and stress factors'') into two
paragraphs, and we revised our wording about history of familial
incidence to ``Any available history of familial incidence'' in final
8.00C3d and 108.00C3d (``Any available history of familial
incidence''). We inserted ``Your exposure to toxins, allergens, or
irritants; seasonal variations; and stress factors'' into final 8.00C3e
(``Your exposure to toxins, allergens or irritants; seasonal
variations; and stress factors'') and 108.00C3e (``Your exposure to
toxins, allergens or irritants; seasonal variations; and stress
factors'').
We relettered subparagraphs 8.00C3e and 108.00C3e (``Your ability
to function outside of a highly protective environment'') through
8.00C3h and 108.00C3h (``Statements you or others make about your
disorder(s), your restrictions, and your daily activities'') to 8.00C3f
through 8.00C3i and 108.00C3f through 108.00C3i, respectively.
Comment: Several commenters asked that we omit the word
``prescribed'' from 8.00D (How do we evaluate the severity of skin
disorders?) because some medically necessary treatments recommended by
medical providers for skin conditions (for example, medicated baths,
frequent bandage changes, or over-the-counter ointments) do not require
a prescription. The commenters believe that this change would better
align with the statement in 8.00B4 (Documented medical need) that
assistive devices do not need to be prescribed in order to be
considered by adjudicators.
Response: We have partially accepted this comment. As the
commenters note, and as is consistent with our other regulations,
medical providers other than physicians may ``prescribe'' or recommend
treatment. To acknowledge this, we are changing the term ``physician''
in 8.00D5b and 108.00d5b (Despite adherence to prescribed medical
treatment for 3 months) to ``medical source'' to account for the types
of treatments identified by the commenters above.\106\ As defined in
our regulations, a ``medical source'' means an individual who is
licensed as a healthcare worker by a State and working within the scope
of practice permitted under State or Federal law, or an individual who
is certified by a State as a speech-language pathologist or a school
psychologist and acting within the scope of practice permitted under
State or Federal law.\107\ Prescribed medical treatment means that a
medical source has instructed the patient to adhere to a specified
treatment, such as any medication, surgery, therapy, the use of durable
medical equipment, or the use of assistive devices. Prescribed
treatment does not include lifestyle modifications, such as dieting,
exercise, or smoking cessation. We will consider any evidence of
prescribed treatment, whether it appears on prescription forms or is
otherwise indicated within a medical source's records. An assistive
device(s), as explained in 8.00B and 108.00B (What are our definitions
for the following terms used in this body system?) of this final rule,
is not a treatment method for a skin disorder. An assistive device(s)
is any device used to improve stability, dexterity, or mobility, and
does not need to be prescribed for adjudicators to consider its use as
long as there is a documented medical need for the assistive device.
---------------------------------------------------------------------------
\106\ 20 CFR 404.1502(d) and 416.902(i).
\107\ Id.
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Comment: A few commenters stated that proposed 8.00D6b (``If, for
any reason, you have not received treatment'') \108\ is contrary to the
``spirit'' of SSR 18-3p (Titles II and XVI: Failure to Follow
Prescribed Treatment).\109\ The commenters added that SSR 18-3p
provides ``several reasons (including religion, inability to pay,
incapacity, intense fear of surgery, risk of opioid addiction, etc.)
why noncompliance with prescribed medicine could be excused.'' The
commenters state that the same exceptions for excusing medical
treatment compliance might be the same reasons why a person has not
received treatment. The commenters recommended that if we do not remove
proposed 8.00D6b (``If, for any reason, you have not received
treatment''), we should state that the reasons from SSR 18-3p are
reasons a skin disorder could meet listing 8.09 (Chronic conditions of
the skin or mucous membranes) without evidence of treatment.
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\108\ Paragraph 8.00D6b (``If, for any reason, you have not
received treatment'') of the proposed and final rule states in part,
``If, for any reason, you have not received treatment, your skin
disorder cannot meet the criteria for 8.09.''
\109\ 83 FR 49616 (2018) and SSR 18-3p (2018). Available at:
<a href="https://www.ssa.gov/OP_Home/rulings/di/02/SSR2018-03-di-02.html">https://www.ssa.gov/OP_Home/rulings/di/02/SSR2018-03-di-02.html</a>.
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Response: We did not adopt these comments. The commenters
misunderstand our policy for failure to follow prescribed treatment in
this instance. We only consider our failure to follow prescribed
treatment policy and procedures after determining that a person is
entitled to disability benefits. Once we determine that a person is
entitled to disability benefits, we determine whether the evidence
indicates that the person might not have been entitled to disability
benefits if they had followed prescribed treatment. Therefore, in the
case of listing 8.09 (Chronic conditions of the skin or mucous
membranes), before we make a failure to follow prescribed treatment
determination, we first need to determine that a person's skin disorder
meets all of our criteria for listing 8.09 (Chronic conditions of the
skin or mucous membranes), including listing criteria related to
treatment. In the introductory text at 8.00D5b (Despite adherence to
prescribed medical treatment for 3 months) we state that under listing
8.09 (Chronic conditions of the skin or mucous membranes), we require
that a person's symptoms persist ``despite adherence to prescribed
treatment for 3 months.'' The adherence to prescribed treatment is a
part of the listing criteria and must be present in order for a
person's skin condition to meet the criteria of the listing. Therefore,
it is not possible to find a person disabled under listing 8.09
(Chronic conditions of the skin or mucous membranes) without a record
of prescribed treatment, which is further explained in paragraph
8.00D6b (``If, for
[[Page 37727]]
any reason, you have not received treatment''). This is clarified by
our guidance in SSR 18-3p (Titles II and XVI: Failure to Follow
Prescribed Treatment), where we explain that a failure to follow
prescribed treatment determination is not applicable when a listed
impairment(s) requires us to consider whether a person was following a
specific treatment as part of satisfying the listing analysis.
Moreover, the requirement for prescribed treatment for skin
disorders dates back to 1979.\110\ We last comprehensively revised the
listings for evaluating skin disorders in 2004. In the preamble to that
final rule, we explained that the original requirement for extensive
lesions ``not responding to prescribed treatment'' was replaced with
the more specific requirement that there be ``extensive skin lesions
that persist for at least 3 months despite continuing treatment as
prescribed.'' \111\ We are retaining that requirement with this update;
however, with this final rule, we are finalizing our proposal to change
the language to ``despite adherence to prescribed medical treatment''
to be more consistent with current medical terminology.
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\110\ 44 FR 18170, 18187 (1979).
\111\ 69 FR 32260, 32264 (2004).
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Additionally, we do not deny a claim if a person does not have an
impairment that meets a listing. We may find the impairment(s)
medically equals a listing (or, in the case of a child seeking
Supplemental Security Income (SSI) payments, functionally equals the
listings). If an adult claimant's impairment(s) does not meet or
medically equal any listing, we may find them disabled at a later step
in the sequential evaluation process. A lack of treatment history, as a
solitary factor, does not require us to deny a claim. We evaluate a
claim, including all record evidence, regardless of whether a person
has received treatment for their impairment(s).
Comment: Several commenters asked us not to finalize the proposed
changes to the functional criteria because the changes we propose to
the skin disorders listings are ``more onerous,'' and they assert that
fewer applicants will qualify for disability based on these updated
criteria. These commenters believed the updates would prolong the
process of applying for disability by necessitating assessment at later
steps in the sequential evaluation process and would require vocational
information and consideration of a person's age, education, and work
experience, to make a determination. The commenters also expressed
concern that these updates will ultimately result in more denials of
claims at the initial and reconsideration levels.
[…truncated; see source link]Indexed from Federal Register on June 8, 2023.
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