[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 [www.gpo.gov]
[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.

-----------------------------------------------------------------------

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 http://www.socialsecurity.gov.

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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 http://www.regulations.gov 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. https://doi.org/10.1016/j.jss.2016.04.036 036.
                                                         Singal, A.K. &
                                                          Kamath, P.S.
                                                          (2013). Model
                                                          for end-stage
                                                          liver disease.
                                                          Journal of
                                                          Clinical and
                                                          Experimental
                                                          Hepatology,
                                                          3(1), 50-60.
                                                          https://doi.org/10.1016/j.jceh.2012.11.002.
                                                         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. https://www.sciencedirect.com/science/article/pii/S0168827815002445?via%3Dihub
                                                          .
------------------------------------------------------------------------

[[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.         https://doi.10.1136/pmj.78.918.198
                                                          .
                                                         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.
                                                          https://www.youtube.com/watch?v=4Oam1yUHiO8 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. https://doi.org/10.1016/j.clnu.2014.08.017.

[[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. https://doi.org/10.1016/j.clnu.2016.01.020.
                                                         Deutsch, L.,
                                                          Cloutier, A.,
                                                          & Lal, S.
                                                          (2020).
                                                          Advances in
                                                          chronic
                                                          intestinal
                                                          failure
                                                          management and
                                                          therapies.
                                                          Current
                                                          opinion in
                                                          gastroenterolo
                                                          gy, 36(3), 223-
                                                          229. https://doi.org/10.1097/MOG.0000000000000631 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. https://doi.org/10.1093/ajcn/nqz110 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.
                                                         https://doi.org/10.4103/0378-6323.144143.
------------------------------------------------------------------------

[[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:
     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.
     We also made minor, editorial changes from the NPRM for 
clarity and readability throughout both digestive disorders and skin 
disorders.

Digestive Disorders

     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)).
     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'').
     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.
     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)).
     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)).
     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.
     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.
     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

     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?)).
     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?)).
     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)).
     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).
---------------------------------------------------------------------------

     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)).
     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.15 16
---------------------------------------------------------------------------

    \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]. https://optn.transplant.hrsa.gov/media/1575/policynotice_20151101.pdf.
    \16\ United Network for Organ Sharing. (2016). 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/.
---------------------------------------------------------------------------

    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.17 18 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.19 20 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. https://doi.org/10.4065/mcp.2010.0281.
    \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. 
https://doi.org/10.1136/gut.2006.102764.
---------------------------------------------------------------------------

    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 `loge' '') and 105.00C3a(ii) (``For any SSA CLD 
calculation'') and 105.00C3a(iii) (``When we indicate `loge' 
'') 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 
`loge' '') 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 20.22 23 24 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. https://doi.org/10.1016/j.jceh.2012.11.002.
    \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. https://doi.org/10.1016/j.jss.2016.04.036.
    \24\ Thornton, K. (2021, February 12). Evaluation and Prognosis 
of Persons with Cirrhosis. Hepatitis C Online. https://www.hepatitisc.uw.edu/go/evaluation-staging-monitoring/evaluation-prognosis-cirrhosis/core-concept/all.
    \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. 
https://doi.org/10.1001/jamapediatrics.2018.2541.
---------------------------------------------------------------------------

    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.31 32 33 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\
---------------------------------------------------------------------------

    \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. https://doi.org/10.3748/wjg.v22.i25.5728.
    \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. https://doi.org/10.1002/hep.30139.
    \32\ Noli, K., Solomon, M., Golding, F., Charron, M., & Ling, 
S.C. (2008). Prevalence of hepatopulmonary syndrome in children. 
Pediatrics, 121(3), e522-527. https://doi.org/10.1542/peds.2007-1075.
    \33\ Arterial Blood Gas (ABG): What It Is, Purpose, Procedure & 
Levels. (2022, February 18.). Cleveland Clinic. https://my.clevelandclinic.org/health/diagnostics/22409-arterial-blood-gas-abg.
    \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. 
https://doi.org/10.1016/j.cgh.2006.12.003.
    \35\ Id.
    \36\ Jubran, A. (2015). Pulse oximetry. Critical Care, 19, 272. 
https://doi.org/10.1186/s13054-015-0984-8.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \41\ 20 CFR 404.1519a and 416.919a.
---------------------------------------------------------------------------

    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 PaO2 measured by an ABG test''), one 
commenter asked us to either use both PaO2 and 
PaCO2 values, or the highest favorable 
PaO2 for each altitude range, as noted in tables 
for PaO2/PaCO2 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.42 43 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 PaO2, not PaCO2, and 
5.05E1 and 105.05E1 consider altitude when determining whether a 
claimant's hepatopulmonary syndrome is listing-level 
severity.45 46 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\
---------------------------------------------------------------------------

    \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. 
https://www.merckmanuals.com/professional/pulmonary-disorders/pulmonary-hypertension/hepatopulmonary-syndrome.
    \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. https://doi.org/10.1056/NEJMra0707185.
    \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. https://doi.org/10.3748/wjg.v22.i25.5728.
    \47\ 20 CFR 404.1526 and 416.926.
---------------------------------------------------------------------------

    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 PaO2 
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\
---------------------------------------------------------------------------

    \48\ SSA has designated hepatopulmonary syndrome as a 
Compassionate Allowance (CAL) condition. See Compassionate 
Allowances website Home Page (ssa.gov).
    \49\ Bansal, K., Gore, M., & Mittal, S. (2022). Hepatopulmonary 
Syndrome. In StatPearls. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK562169.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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. https://doi.org/10.1097/01.sla.0000161030.25860.c1.
---------------------------------------------------------------------------

    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.51 52 53 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?).
---------------------------------------------------------------------------

    \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. https://doi.10.1136/pmj.78.918.198.
    \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. https://www.youtube.com/watch?v=4Oam1yUHiO8.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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. https://doi.10.1136/gut.2006.091108.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.61 62 63 64 65 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?).
---------------------------------------------------------------------------

    \61\ Thompson JS, Rochling FA, Weseman RA, Mercer DF. Current 
management of short bowel syndrome. Curr Probl Surg 49:52-115, 2012. 
https://doi.org/10.1067/j.cpsurg.2011.10.002.
    \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. https://doi.org/10.1016/j.clnu.2014.08.017.
    \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. https://doi.org/10.1016/j.clnu.2016.01.020.
    \64\ Deutsch, L., Cloutier, A., & Lal, S. (2020). Advances in 
chronic intestinal failure management and therapies. Current opinion 
in gastroenterology, 36(3), 223-229. https://doi.org/10.1097/MOG.0000000000000631.
    \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. https://doi.org/10.1093/ajcn/nqz110.
---------------------------------------------------------------------------

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 66 67 
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.68 69 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. 
https://doi.org/10.1177/0884533614557642.
    \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. https://doi.org/10.1177/0148607112440285.
    \68\ Gounden, V., Vashisht, R., & Jialal, I. (2021). 
Hypoalbuminemia. In StatPearls [internet]. StatPearls Publishing. 
https://www.ncbi.nlm.nih.gov/books/NBK526080/.
    \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. https://www.nhlbi.nih.gov/files/docs/public/blood/anemia-yg.pdf.
---------------------------------------------------------------------------

    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. https://www.cdc.gov/healthyweight/assessing/bmi/adult_bmi/index.html. 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.72 73
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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. 
https://doi.org/10.1159/000505368.
    \73\ Ramos, G.P., & Papadakis, K.A. (2019). Mechanisms of 
disease: Inflammatory bowel diseases. Mayo Clinic Proceedings, 
94(1), 155-165. https://doi.org/10.1016/j.mayocp.2018.09.013.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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 https://www.cdc.gov/nchs/data/series/sr_11/sr11_246.pdf.
    \79\ Id.
    \80\ Id.
    \81\ National Center for Health Studies. (2017, June). Clinical 
Growth Charts. Centers for Disease Control and Prevention. https://www.cdc.gov/growthcharts/clinical_charts.htm.
    \82\ 20 CFR 416.925.
---------------------------------------------------------------------------

    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. https://emedicine.medscape.com/article/431783-treatment.
    \84\ Roayaie, K., & Feng, S. Liver transplant. University of 
California San Francisco Transplant Surgery Department of Surgery. 
https://transplantsurgery.ucsf.edu/conditions--procedures/liver-transplant.aspx.
    \85\ Mayo Clinic Staff. (2020, July 15). Liver transplant. Mayo 
Clinic. https://www.mayoclinic.org/tests-procedures/liver-transplant/about/pac-20384842.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.88 89 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. 
https://doi.org/10.5223/pghn.2018.21.1.12.
    \89\ 20 CFR 416.906 and 416.909.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    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: https://www.ssa.gov/OP_Home/rulings/di/01/SSR2016-03-di-01.html.
    \93\ SSR 18-3p (2018). Available at: https://www.ssa.gov/OP_Home/rulings/di/02/SSR2018-03-di-02.html.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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. https://doi.org/10.17226/24740.
    \99\ 85 FR 78164 (2020).
---------------------------------------------------------------------------

    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: https://www.ssa.gov/OP_Home/rulings/di/02/SSR85-15-di-02.html.
    \101\ SSR 09-6p (2009). Available at: https://www.ssa.gov/OP_Home/rulings/ssi/02/SSR2009-06-ssi-02.html.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \102\ 20 CFR 404.1545(d) and 416.945(d).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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. https://doi.org/10.1111/ddg.13140.
    \105\ DeStefano, G.M., & Christiano, A.M. (2014) The genetics of 
human skin disease. Cold Spring Harbor Perspectives in Medicine, 
4(10), a015172. https://doi.org/10.1101/cshperspect.a015172.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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: 
https://www.ssa.gov/OP_Home/rulings/di/02/SSR2018-03-di-02.html.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \110\ 44 FR 18170, 18187 (1979).
    \111\ 69 FR 32260, 32264 (2004).
---------------------------------------------------------------------------

    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. For instance, the 
commenters suggested that a person's skin disorder would be unable to 
meet a skin disorders listing if only one side of a groin and an axilla 
(underarm) was involved instead of both sides of the groin or the 
axillae (underarms).
    Response: We did not adopt these comments. The requirement that the 
claimant's skin disorder results in significant functional limitations 
lasting a minimum of 12 months despite adherence to treatment dates 
back to 1979.\112\ 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.'' \113\ This is a requirement 
in our current rule as well, which states that we require evidence that 
the claimant's skin disorder results in a degree of functional 
limitation such that the claimant is ``unable to do any gainful 
activity for a continuous period of at least 12 months'' (see current 
8.00C2 and 108.00C2 (Frequency of flare-ups)). The language in the 
final rule reflects a continuation of this requirement, stating that we 
must have medically documented evidence of physical limitation(s) of 
functioning related to the claimant's skin disorder, and that the 
decrease in physical function resulting from the claimant's skin 
disorder must have lasted, or can be expected to last, for a continuous 
period of at least 12 months (8.00D2 and 108.00D2 (Limitation(s) of 
physical functioning due to skin disorders). Further, this is 
consistent with our program-wide rules for the Listing of Impairments, 
which identify impairments that preclude the ability to perform any 
gainful activity (or, in the case of a child applying for SSI payments 
based on disability, which identify impairments that result in marked 
and severe functional limitations) and have lasted or can be expected 
to last for a continuous period of at least 12 months.\114\
---------------------------------------------------------------------------

    \112\ 44 FR 18170, 18187 (1979), 45 FR 55566, 55607 (1980), and 
50 FR 50068, 50098 (1985).
    \113\ 44 FR at 18787.
    \114\ 20 CFR 404.1525 and 416.925.
---------------------------------------------------------------------------

    Also consistent with our rules dating back to 1979, our current 
rule acknowledges that because skin disorders frequently respond to 
treatment, we must have evidence of treatment for a ``sufficient time'' 
before we can appropriately assess the impact of the treatment and the 
resultant effects on the claimant's functional capacity (see current 
8.00C4 and 108.00C4 (Treatment)). For current adult listings 8.02 
(Ichthyosis) through 8.06 (Hidradenitis suppurativa) and the equivalent 
current childhood listings 108.02 through 108.06, which have been 
consolidated into listings 8.09 and 108.09 (Chronic conditions of the 
skin or mucous membranes) in this final rule, the claimant must adhere 
to prescribed medical treatment for at least three months. The 
continued presence of the skin disorder despite adherence to prescribed 
medical treatment for at least three months allows the adjudicator to 
make a reasonable presumption that the skin disorder will meet the 
durational requirement for disability.\115\ However, medical evidence 
only showing the continued presence of a skin disorder despite 
adherence to prescribed treatment is insufficient to find that the 
claimant's skin disorder meets the listing criteria. In order to find 
that the claimant's skin impairment meets a listing, we must have 
evidence of listing-level functional limitation that has lasted, or can 
be expected to last, for a continuous period of at least 12 months.
---------------------------------------------------------------------------

    \115\ 20 CFR 404.1509 and 416.909.
---------------------------------------------------------------------------

    Addressing the commenters' concern that our new functional criteria 
are more onerous, we specifically refer to certain areas of the body in 
the current and in this final rule. Generally, skin disorders that 
affect these areas, such as ichthyosis and bulbous diseases, result in 
functional limitations. This is not a change from our current criteria. 
In our current criteria at 8.00C1 and 108.00C1 (Extensive skin 
lesions), we define ``extensive skin lesions,'' which we require in 
current adult listings 8.02 (Ichthyosis) through 8.06 (Hidradenitis 
suppurativa) and current childhood listings 108.02 (Ichthyosis) through 
108.06 (Hidradenitis suppurativa), 8.07B and 108.07B (``Other genetic 
photosensitivity disorders''), and 8.08 and 108.08 (Burns), as lesions 
that ``involve multiple body sites or critical body areas, and result 
in a very serious limitation.'' We provide examples of ``extensive skin 
lesions,'' to include conditions such as ``skin lesions that interfere 
with the motion of your joints and that very seriously limit your use 
of more than one extremity,'' ``skin lesions on the palms of both hands 
that very seriously limit your ability to do fine and gross motor 
movements,'' and ``skin lesions on the soles of both feet, the 
perineum, or both inguinal areas that very seriously limit your ability 
to ambulate.''

[[Page 37728]]

    The updated functional criteria for skin disorders reflect our 
continued focus on the functional limitations skin disorders may cause 
and reflect a level of functional limitation similar to the criteria in 
our current rules. In order to clarify that focus, we have moved from 
providing examples of listing-level limitations caused by skin 
disorders, as we do in the current introductory text, to the use of 
precise and functional criteria set forth in this final rule at 8.00D2 
and 108.00D2 (Limitation(s) of physical functioning due to skin 
disorders). The articulation of these specific functional criteria 
prompts adjudicators to focus on the resultant functional limitations 
caused by the claimant's skin impairment in a consistent manner across 
cases. In the proposed rule, and in this final rule, we specify that a 
medically determinable skin impairment will generally meet a listing 
when it has or can be expected to last for a continuous period of at 
least 12 months and is medically documented by one of the functional 
limitations in these listings. This means that the updated rule will 
not necessarily result in a denial. To use the example cited by the 
commenter, a person's skin impairment resulting in lesions on an axilla 
and one side of the groin may still meet one of these listings, because 
there may be medical documentation that the chronic skin lesions or 
contractures result in limitations that satisfy at least one of the 
functional criteria provided.
    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.\116\ 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.\117\
---------------------------------------------------------------------------

    \116\ 20 CFR 404.1520 and 416.920.
    \117\ 20 CFR 416.924.
---------------------------------------------------------------------------

    Comment: A few commenters asked us to remove the words ``third-
degree'' from proposed 8.08 and 108.08 (Burns). The commenters stated 
that fourth-degree burns, which go beyond the skin and underlying 
tissue to muscles and bones, are at least as detrimental to functioning 
as third-degree burns, and that second-degree burns, especially, but 
not only in combination with higher-degree burns, can cause scarring 
that causes pain and limits function.
    Response: We adopted this comment and removed the qualifier 
``third-degree'' from listings 8.08 and 108.08 (Burns). The comment 
brought a perspective that we hadn't considered. We adopted the comment 
and removed the qualifier ``third degree'' from listing 8.08 and 108.08 
because skin lesions and contractures that affect function, although 
often caused by third-degree burns, can also be caused by deep partial 
thickness (deep second degree) burns or fourth-degree burns.\118\ 
Additionally, the measurement of burn depth in the medical record is 
not always precise because many providers have difficulty accurately 
assessing burn depth, there is a need for development of adequate 
methods of precisely measuring burn depth, and burns often progress to 
a greater depth than initially documented.119 120 121 122
---------------------------------------------------------------------------

    \118\ Jeschke, M.G., van Baar, M.E., Choudhry, M.A., Chung, 
K.K., Gibran, N.S., & Logsetty, S. (2020). Burn injury. Nature 
reviews. Disease primers, 6(1), 11. https://doi.org/10.1038/s41572-020-0145-5.
    \119\ Id.
    \120\ Bettencourt, A.P., Romanowski, K.S., Joe, V., Jeng, J., 
Carter, J.E., Cartotto, R., Craig, C.K., Fabia, R., Vercruysse, 
G.A., Hickerson, W.L., Liu, Y., Ryan, C.M., & Schulz, J.T. (2020). 
Updating the Burn Center Referral Criteria: Results From the 2018 
eDelphi Consensus Study. Journal of burn care & research: official 
publication of the American Burn Association, 41(5), 1052-1062. 
https://doi.org/10.1093/jbcr/iraa038.
    \121\ Burgess, M., Valdera, F., Varon, D., Kankuri, E., & 
Nuutila, K. (2022). The Immune and Regenerative Response to Burn 
Injury. Cells, 11(19), 3073. https://doi.org/10.3390/cells11193073.
    \122\ Markiewicz-Gospodarek, A., Kozio[lstrok], M., Tobiasz, M., 
Baj, J., Radzikowska-B[uuml]chner, E., & Przekora, A. (2022). Burn 
Wound Healing: Clinical Complications, Medical Care, Treatment, and 
Dressing Types: The Current State of Knowledge for Clinical 
Practice. International journal of environmental research and public 
health, 19(3), 1338. https://doi.org/10.3390/ijerph19031338.
---------------------------------------------------------------------------

    Comment: One commenter asked us to reorder the proposed listings in 
a more manageable and understandable fashion. Specifically, the 
commenter stated that by eliminating listings 8.02 (Ichthyosis) through 
8.09 (Chronic conditions of the skin or mucous membranes) and 108.02 
(Ichthyosis) through 108.09 (Chronic conditions of the skin or mucous 
membranes) we made these listings more complicated to read and 
administer. The commenter stated that for the relatively unusual skin 
conditions, cross-referencing and placing all of the examples of skin 
conditions in the current listings into proposed listings 8.09 and 
108.09 (Chronic conditions of the skin or mucous membranes) made these 
listings confusing for adjudicators, advocates, and lay people.
    Response: We have partially adopted these comments. We did not 
adopt the commenter's suggestion to reorder the skin disorders 
listings; contrary to the commenter's assertion, we did not eliminate 
listings 8.09 and 108.09 (Chronic conditions of the skin and mucous 
membranes). These are new listings in the proposed rule. Similarly, we 
did not eliminate listings 8.02 (Ichthyosis) through 8.08 (Burns) and 
108.02 (Ichthyosis) through 108.08 (Burns). Rather, we removed adult 
listings 8.02 (Ichthyosis) through 8.06 (Hidradenitis suppurativa) and 
childhood listings 108.02 (Ichthyosis) through 108.06 (Hidradenitis 
suppurativa), and consolidated their current repetitive criteria into 
one listing for chronic conditions of the skin or mucous membranes 
(revised 8.09 and 108.09 (Chronic conditions of the skin and mucous 
membranes)), regardless of whether the condition is commonly known or 
relatively rare, to strengthen adjudicative ease and more efficiently 
identify adults and children with skin disorders of listing-level 
severity. As we explained in the NPRM, the criteria in the current 
listings are identical for each type of skin disorder, and all of the 
named disorders are chronic conditions of the skin or mucous 
membranes.\123\ For instance, adjudicators will not need to search 
examples of skin conditions in various skin disorders listings to 
locate a person's listed medically determinable skin impairment. If 
``relatively unusual skin conditions'' are not in the listed examples 
of skin disorders, the adjudicator will no longer need to determine 
which listed impairment(s) is most comparable to a person's medically 
determinable impairment of the skin or mucous membranes to proceed with 
evaluating the claim.
---------------------------------------------------------------------------

    \123\ 84 FR 35936 (2019).
---------------------------------------------------------------------------

    As for the commenter's assertion that the revised skin listings are 
confusing and more complicated to read, we addressed the commenter's 
concerns by revising 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 improve 
the clarity and readability of these listings. Specifically, we removed 
repetitive language related to impairment-related limitations. In 
addition to revising the language in these listings to make the 
criteria easier to understand and apply, we moved the 8.00D2 and 
108.00D2 (Limitation(s) of physical functioning due to skin disorders) 
cross references from 8.09A to 8.09B and from 108.09A to 108.09B, 
respectively, to align with the terms they describe. We did not make 
any other changes to the cross references. Regarding the use of cross 
references in revised listing 8.09 (Chronic conditions of the skin or 
mucous membranes), we use cross references throughout the listings for 
body systems to assist adjudicators, advocates, and lay people with 
understanding and locating terms

[[Page 37729]]

and phrases specific to the evaluation of certain listing criteria. We 
also use cross references to assist readers with recalling other 
listings or rules that affect how we evaluate specific impairments.
    Comment: One commenter asked that we not replace the plain language 
term ``flare-ups'' with the medical term ``exacerbations.''
    Response: We did not adopt the suggestion to remove the term 
``exacerbations,'' but we did add language to reflect the commenter's 
request to see ``flare-ups'' reflected as well. In the final rule, we 
clarified the definition of the term ``exacerbation.'' \124\ We must 
use appropriate, modern medical terminology to specify the medical 
criteria we use to evaluate skin disorders, and our research indicates 
that ``exacerbation'' is the preferred term among professionals in the 
field of dermatology.\125\ Additionally, we use the term 
``exacerbation'' and not ``flare-up'' throughout the rules for numerous 
body systems, so adding the word in the listing for skin disorders will 
allow for consistency across the multiple body systems.\126\ In this 
final rule, we added a definition to 8.00B and 108.00B (What are our 
definitions for the following terms used in this body system?) based on 
the medical definition for ``exacerbation''; \127\ however, we also 
mentioned alternative terms such as ``flare'' and ``flare-up,'' to 
reflect the commenter's desire to see the historical term ``flare-up'' 
in the listing.
---------------------------------------------------------------------------

    \124\ Paragraphs 8.00B7 and 108.00B7 (Exacerbation) of the final 
rule define exacerbation as ``an increase in the signs or symptoms 
of the skin disorder.''
    \125\ A review of the website for the Journal of the American 
Medical Association (JAMA), a peer-reviewed medical journal 
published 48 times a year by the American Medical Association, found 
that the term ``exacerbation'' was used more than twice as often as 
the term ``flare-up.''
    \126\ We use the term ``exacerbations'' throughout our 
respiratory listings (3.00E2, 3.00J, 3.02D, 3.03B, 3.04B, 3.04G, and 
3.07, as well as their childhood equivalents), in our current and 
revised digestive listings (5.00E and 105.00E in the current rules 
and 5.00D and 105.00D in the revised rule), as well as in the 
hematological (7.00G), neurological (11.00G, 11.00N1, and 111.00O), 
mental (12.00F4, 12.00G, 112.00F4, and 112.00G), and the immune 
listings (14.00I and 114.00I). We do not use the term ``flare-up'' 
in any other body system.
    \127\ Taber's Cyclopedic Medical Dictionary--23rd Ed. (2017).
---------------------------------------------------------------------------

    Comment: One commenter stated that many of the terms used in these 
rules are not defined well enough for adjudicators and the public. The 
commenter provided the examples of ``inability,'' ``maintain an upright 
position,'' ``fine and gross motor movements,'' ``picking,'' 
``pinching,'' ``manipulating and ``fingering,'' ``handling,'' 
``gripping and grasping,'' ``holding,'' ``turning,'' ``reaching,'' 
``lifting and carrying,'' ``seriously,'' ``marked,'' and ``prescribed 
treatment.''
    Response: We disagree with this comment. This rule uses ``fine and 
gross movements'' (not ``fine and gross motor movements''), which is a 
term defined in 8.00B5 and 108.00B5 (Fine and gross movements). The 
majority of the terms identified by this commenter are examples of fine 
movements \128\ and gross movements.\129\ We use these terms, as well 
as ``inability,'' ``maintain,'' ``upright position,'' ``prescribed,'' 
and ``treatment'' in this rule as they are defined in common English 
usage. As we explained in the NPRM, we replaced the current term 
``continuing treatment as prescribed'' with ``adherence to prescribed 
medical treatment'' to be consistent with current medical terminology. 
We changed ``prescribed treatment'' in 8.00D2 and 108.00D2 
(Limitation(s) of physical functioning due to skin disorders) to 
``prescribed medical treatment'' to be consistent with current medical 
terminology. Further, throughout this rule we provide numerous examples 
of what we will consider as ``marked'' limitation(s).
---------------------------------------------------------------------------

    \128\ Fine movement examples include picking, pinching, 
manipulating, and fingering.
    \129\ Gross movement examples include handling, gripping, 
grasping, holding, turning, lifting, and carrying.
---------------------------------------------------------------------------

Other Comments
    Comment: One commenter expressed concern that we do not provide 
quantitative data to show the ``validity'' of these listings and noted 
that many people engage in work even though their impairments meet the 
listing requirements. The commenter opined that this ``challenges the 
credibility'' of using the listings to determine whether a person is 
disabled, and that the listings conflict with the statutory definition 
of disability. Several other commenters expressed concern that we do 
not provide any justification for making what they characterize as 
substantial changes.
    Response: We did not make any changes in this final rule based on 
these comments. Contrary to the commenters' assertion, we provided 
justification and sources for our changes. In the NPRM, we included an 
extensive list of references that we relied on in proposing this 
rule.\130\ We also invited the public to comment on these references 
and the data contained within them. The listings help ensure that 
determinations and decisions of disability have a sound medical basis, 
that claimants receive equal treatment throughout the country, and that 
we can readily identify a significant number of people who meet our 
definition of disabled. The level of severity described in the listings 
is such that we consider a person who is not engaging in SGA, and who 
has an impairment that meets or medically equals all of the criteria of 
the listing, to generally be unable to do any gainful activity because 
of the medical impairment alone at step 3 of the sequential evaluation 
process. When such impairment or combination of impairments meets or 
medically equals the level of severity described in the listing for the 
required duration, we will find the person disabled on the basis of 
medical facts alone in the absence of evidence to the contrary (for 
example, the actual performance of SGA).
---------------------------------------------------------------------------

    \130\ 84 FR 35936 (2019).
---------------------------------------------------------------------------

    Comment: Two commenters opined that our proposed revisions 
discriminate against the poor because the criteria in the listings 
depend on specific diagnoses that, in turn, require medical tests that 
many people cannot afford and that we will not purchase. The commenters 
noted that these tests are not specifically required by the listings, 
but that they still help establish disability for those people who are 
able to afford them.
    Response: We did not make any changes in this final rule based on 
these comments. The Act and our regulations require a claimant to 
submit medical evidence to establish a medically determinable 
impairment. We use medical evidence generally accepted in the medical 
community and available in medical records to establish and determine 
the severity of an impairment. We consider all available evidence about 
a claimant's impairments, not just information about a particular 
allegation, such as a skin or digestive condition. If we determine a 
medical source cannot or will not give us sufficient medical evidence 
about a person's impairment for us to determine whether a person is 
disabled, we may also purchase medical examinations or tests to obtain 
the evidence that we need.\131\ We can also find a person disabled even 
if they do not have a medical diagnosis for their impairment(s) when 
applying for benefits, as long as we are able to establish a medically 
determinable severe physical or mental impairment or combination of 
impairments that meets the duration requirements.
---------------------------------------------------------------------------

    \131\ 20 CFR 404.1517, 404.1519, 404.1519a-404.1519f, 404.1519k, 
416.917, 416.919, 416.919a-419.919f, and 416.919k.
---------------------------------------------------------------------------

    Comment: One commenter stated that the number of combinations of 
disorders

[[Page 37730]]

from different body systems far exceeds the number of disorders in any 
single body system. For example, if there are 100 different digestive 
disorders and 100 different skin disorders, there are 10,000 
combinations of digestive and skin disorders. The commenter added that 
our proposed listings only include single disorders and leave out many 
important combinations of disorders. The commenter stated that we have 
only covered a tiny fraction of the possible disorders two at a time. 
The commenter alleged that proposed listings discriminate in favor of 
those with severe single body system disorders and against those with 
combinations of disorders.
    Response: We did not adopt this comment. We recognize that 
digestive disorders and skin disorders may co-occur with impairments in 
other body systems. In some cases, the impairment in another body 
system results from a digestive disorder or a skin disorder. In other 
cases, the impairment in another body system is not related to the 
digestive disorder or the skin disorder. We intend the listings for 
digestive disorders to address digestive disorders and the 
complications of those disorders. We intend the listings for skin 
disorders to address skin disorders and the complications of those 
disorders. When the co-occurring condition or complication is due to a 
digestive disorder or skin disorder, we evaluate it under the digestive 
disorders listings or skin disorders listings, as appropriate. However, 
when the co-occurring impairments are unrelated, we evaluate the 
combination 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. We evaluate unrelated co-occurring 
impairments at these steps because adjudicators can account for 
specific combinations of impairments, complications of those 
impairments, and limitations of functioning on an individual case 
basis. We address this in the introductory text of the digestive 
disorders listings at 5.00J and 105.00L (How do we evaluate digestive 
disorders that do not meet one of these listings?) and in the 
introductory text of the skin disorders listings at 8.00I and 108.00I 
(How do we evaluate skin disorders that do not meet one of these 
listings?).

What is our authority to make rules and set procedures for determining 
whether a person is disabled under our statutory definition?

    Under the Act, we have authority to make rules and regulations and 
to establish necessary and appropriate procedures to carry out such 
provisions.\132\
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    \132\ See sections 205(a), 702(a)(5), and 1631(d)(1) (42 U.S.C. 
405(a), 902(a)(5), 1383(d)(1)).
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How long will this final rule be in effect?

    This final rule will remain in effect for 5 years after the date it 
becomes effective, unless we extend, revise, or issue it again. We will 
continue to monitor this rule to ensure that it continues to meet 
program purposes and may revise it before the end of the 5-year period 
if warranted.

How we will implement this final rule?

    We will begin to apply this final rule to new applications, pending 
claims, and continuing disability reviews (CDR), as appropriate, as of 
the effective date of this final rule.\133\
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    \133\ We will use the final rule beginning on its effective 
date. We will apply the final rule to new applications filed on or 
after the effective date, and to claims that are pending on and 
after the effective date. This means that we will use the final rule 
on and after its effective date in any case in which we make a 
determination or decision, including CDRs, as appropriate. See 20 
CFR 404.902 and 416.1402.
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Regulatory Procedures

Executive Order 12866, as Supplemented by Executive Order 13563

    We consulted with the Office of Management and Budget (OMB) and 
determined that this final rule meets the criteria for a significant 
regulatory action under Executive Order (E.O.) 12866, as supplemented 
by E.O. 13563 and is subject to OMB review. Therefore, OMB reviewed the 
rule. Details about the economic impacts of this rule follow.

Anticipated Costs to Our Programs

    In 2018, we conducted a case study covering about 500 initial 
Disability Determination Service (DDS)-level decisions within the 
digestive and skin body systems, based on the proposed rule as 
developed at that time. The case study sample was stratified by 
specific diagnosis categories and included both listing-level 
allowances as well as denials at the medical-vocational stage of the 
disability determination process. Implementation of this final rule 
would result in decisional changes relative to decisions in these body 
systems both from allowance to denial and from denial to allowance.
    Estimates presented below reflect some changes to the final rule 
from the NPRM. The NPRM was used to develop and conduct the original 
case study. We conducted several different analyses of the original 
case study to determine the potential effects of the changes in this 
final rule on the original case study results. Only one of the changes 
in this final rule affected the case study results, which was the 
reversion of changes proposed in the NPRM in the digestive listing for 
weight loss due to any disorder to the criteria used under current 
rules. Therefore, we expect no decisional changes under this particular 
weight loss listing in the final rule relative to current policy. Of 
the other cases found to be affected by the changes in the proposed 
rule, we concluded that none of them in the case study would have a 
different decision under the final rule compared to the evaluation 
under the proposal as they stood at the time of the original case 
study.
    Therefore, based on the results from the case study, we estimate 
that the combined additional allowances and additional denials under 
these listings together will likely result in a small net decrease in 
total allowances for the Old-Age, Survivors and Disability Insurance 
(OASDI) and SSI programs combined, but different effects for each 
program separately. For the OASDI program, we estimate net changes from 
the digestive and skin listings individually that are opposite in 
effect, a net annual average increase in allowances under the digestive 
listings of about 100 allowances, and a net annual average decrease 
under the skin listings of about 95 allowances, with the combined net 
effect being an increase of about five allowances on an annual average 
basis. This small net increase results in an estimated net increase of 
$15 million in scheduled OASDI benefit payments for the listings 
combined over the projection period fiscal years (FY) 2024-33. For the 
SSI program, we estimate net reductions for each of the digestive and 
skin listings individually, with a net annual average decrease in 
allowances under the digestive listings of about five allowances, and a 
net annual average decrease in allowances under the skin listings of 
about 155 allowances, with the net combined effect being a net decrease 
of about 160 allowances per year on average.
    These estimated effects are based on a stratified random case study 
of approximately 425 cases, 175 of which were allowed under the 
listings in effect prior to publication of this rule, and 250

[[Page 37731]]

denials. Approximately two-thirds of these cases involved the changes 
to the digestive listings, and the remaining involved the skin 
listings. The results of that case study indicated that for each of 
these listings there would be decisional changes in both directions: 
some allowances would be denied under these rules, and some denials 
would be allowed under these rules. The net effects of these changes 
for the skin listings indicated that the number of cases allowed would 
be slightly reduced under these new rules for both the OASDI and SSI 
programs. For the changes to the digestive listings, however, the case 
study results indicated differing net effects for OASDI and SSI. This 
is primarily a result of differences in current allowance rates under 
OASDI and SSI for the specific digestive listings that would be 
modified by publication of these new rules. OASDI applicants involving 
digestive impairment have a much lower current allowance rate than 
similar SSI applicants. Because the case study results indicate changes 
in both directions, the net effects depend in part on current allowance 
rates for the listings specifically modified by the changes to the 
digestive rules.
    Our actuarial analysis based on these estimated net changes in SSI 
allowances indicates a net reduction in Federal SSI payments of $51 
million for the listings combined over the projection period FY 2024-
33. Estimates are based on the assumption that the new rule would apply 
to all disability determinations completed beginning October 1, 2023.

Anticipated Administrative Costs to the Social Security Administration

    In calculating whether the implementation of this final rule will 
result in administrative costs or savings to the agency, we examined 
two sources: (1) Work-years and (2) direct financial administrative 
costs.
    We define work-years as a measure of the SSA employee work time 
this final rule will cost or save during implementation of its 
policies. We calculate one work-year as 2,080 hours of labor, which 
represents the amount of hours one SSA employee works per year based on 
a standard 40-hour workweek.
    The Office of Budget, Finance, and Management estimates net 
administrative costs of less than 15 work-years and $2 million 
annually, which we consider to be a non-significant amount.

Anticipated Costs to the Public

    We do not believe there are any more than de minimis costs to the 
public associated with this rulemaking. As discussed earlier in our 
responses to comments on the Notice of Proposed Rulemaking as well as 
in the Paperwork Reduction Action section below, the requirements 
contained in this rulemaking will not impose new additional costs 
outside of the normal course of business for applicants or change how 
the public interacts with our disability programs. Most of the 
revisions made to the digestive and skin listings improve clarity, 
readability, and application of the listings as well as consistency 
among the listings as a whole. We do not believe the requirements 
contained in the new digestive and skin disorders listings will impose 
additional costs or documentation requirements to applicants or cause 
the affected applicants to pursue a different course of treatment than 
they otherwise would have done under our existing rules.

Congressional Review Act

    This final rule is not a major rule as defined by the Congressional 
Review Act.\134\
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    \134\ 5 U.S.C. 801 et seq.
---------------------------------------------------------------------------

Executive Order 13132 (Federalism)

    We analyzed this final rule in accordance with the principles and 
criteria established by E.O. 13132, and determined that it will not 
have sufficient Federalism implications to warrant the preparation of a 
Federalism assessment. We also determined that the final rule will not 
preempt any State law or State regulations or affect the States' 
abilities to discharge traditional State governmental functions.

Regulatory Flexibility Act

    We certify that this final rule will not have a significant 
economic impact on a substantial number of small entities because it 
affects individuals only. Therefore, the Regulatory Flexibility Act, as 
amended, does not require us to prepare a regulatory flexibility 
analysis.

Paperwork Reduction Act

    This final rule only updates the criteria in the Listing of 
Impairments (listings) that we use to evaluate disability claims 
involving both digestive and skin disorders under titles II and XVI of 
the Social Security Act but does not create any new or affect any 
existing collections. Accordingly, it does not impose any burdens under 
the Paperwork Reduction Act and does not require further OMB approval.

(Catalog of Federal Domestic Assistance Program Nos. 96.001, Social 
Security--Disability Insurance; 96.002, Social Security--Retirement 
Insurance; 96.004, Social Security--Survivors Insurance; and 96.006, 
Supplemental Security Income)

List of Subjects

20 CFR Part 404

    Administrative practice and procedure; Blind, Disability benefits; 
Old-age, survivors, and disability insurance; Reporting and 
recordkeeping requirements; Social Security.

20 CFR Part 416

    Administrative practice and procedure; Aged, Blind, Disability cash 
payments; Public assistance programs; Reporting and recordkeeping 
requirements; Supplemental Security Income (SSI).

    The Acting Commissioner of Social Security, Kilolo Kijakazi, Ph.D., 
M.S.W., having reviewed and approved this document, is delegating the 
authority to electronically sign this document to Faye I. Lipsky, who 
is the primary Federal Register Liaison for the Social Security 
Administration, for purposes of publication in the Federal Register.

Faye I. Lipsky,
Federal Register Liaison, Office of Legislation and Congressional 
Affairs, Social Security Administration.

    For the reasons set out in the preamble, we are amending subpart P 
of part 404 of chapter III of title 20 of the Code of Federal 
Regulations as set forth below:

PART 404--FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE 
(1950-)

Subpart P--Determining Disability and Blindness

0
1. The authority citation for subpart P of part 404 continues to read 
as follows:

    Authority:  Secs. 202, 205(a)-(b) and (d)-(h), 216(i), 221(a) 
and (h)-(j), 222(c), 223, 225, and 702(a)(5) of the Social Security 
Act (42 U.S.C. 402, 405(a)-(b) and (d)-(h), 416(i), 421(a) and (h)-
(j), 422(c), 423, 425, and 902(a)(5)); sec. 211(b), Pub. L. 104-193, 
110 Stat. 2105, 2189; sec. 202, Pub. L. 108-203, 118 Stat. 509 (42 
U.S.C. 902 note).


0
2. Amend appendix 1 to subpart P of part 404 as follows:
0
a. In the introductory text before part A, revise paragraphs 6 and 9;
0
b. In part A:
0
i. Amend the table of contents for part A by revising the entry for 
section 5.00;
0
ii. Revise section 5.00;
0
iii. Amend section 6.00 by revising paragraph 6.00C7;
0
iv. Revise section 8.00;
0
v. Amend section 14.00 by revising paragraph 14.00F5;
0
c. In part B:

[[Page 37732]]

0
i. Amend the table of contents for part B by revising the entry for 
section 105.00;
0
ii. Amend section 100.00 by revising paragraph 100.00C2c;
0
iii. Amend section 103.00 by revising paragraph 103.00K2c;
0
iv. Amend section 104.00 by revising paragraph 104.00C3b(iii);
0
v. Revise section 105.00;
0
vi. Amend section 106.00 by revising paragraph 106.00C5b(iii);
0
vi. Revise section 108.00; and
0
viii. Amend section 114.00 by revising paragraph 114.00F7b(iii).
    The revisions read as follows:

Appendix 1 to Subpart P of Part 404--Listing of Impairments

* * * * *
    6. Digestive Disorders (5.00 and 105.00): October 6, 2028.
* * * * *
    9. Skin Disorders (8.00 and 108.00): October 6, 2028.
* * * * *

Part A

* * * * *

Sec.

* * * * *

5.00 Digestive Disorders

* * * * *

5.00 Digestive Disorders

    A. Which digestive disorders do we evaluate in this body system? 
We evaluate digestive disorders that result in severe dysfunction of 
the liver, pancreas, and gastrointestinal tract (the large, muscular 
tube that extends from the mouth to the anus, where the movement of 
muscles, along with the release of hormones and enzymes, allows for 
the digestion of food) in this body system. Examples of these 
disorders and the listings we use to evaluate them include chronic 
liver disease (5.05), inflammatory bowel disease (5.06), and 
intestinal failure (5.07). We also use this body system to evaluate 
gastrointestinal hemorrhaging from any cause (5.02), weight loss due 
to any digestive disorder (5.08), liver transplantation (5.09), 
small intestine transplantation (5.11), and pancreas transplantation 
(5.12). We evaluate cancers affecting the digestive system under the 
listings in 13.00.
    B. What evidence do we need to evaluate your digestive disorder? 
1. General. To establish that you have a digestive disorder, we need 
medical evidence about the existence of your digestive disorder and 
its severity. Medical evidence should include your medical history, 
physical examination findings, operative reports, and relevant 
laboratory findings.
    2. Laboratory findings. We need laboratory reports such as 
results of imaging (see 5.00B3), endoscopy, and other diagnostic 
procedures. We may also need clinical laboratory and pathology 
results. 3. Imaging refers to medical imaging techniques, such as x-
ray, ultrasound, magnetic resonance imaging, and computerized 
tomography. The imaging must be consistent with the prevailing state 
of medical knowledge and clinical practice as a proper technique to 
support the evaluation of the disorder.
    C. What is chronic liver disease (CLD), and how do we evaluate 
it under 5.05?
    1. General. CLD is loss of liver function with cell necrosis 
(cell death), inflammation, or scarring of the liver that persists 
for more than 6 months. Common causes of CLD in adults include 
chronic infection with hepatitis B virus or hepatitis C virus, and 
prolonged alcohol abuse.
    a. We will evaluate your signs of CLD, such as jaundice, changes 
in size of the liver and spleen, ascites, peripheral edema, and 
altered mental status. We will also evaluate your symptoms of CLD, 
such as pruritus (itching), fatigue, nausea, loss of appetite, and 
sleep disturbances when we assess the severity of your impairment(s) 
and how it affects your ability to function. In the absence of 
evidence of a chronic liver impairment, episodes of acute liver 
disease do not meet the requirements of 5.05.
    b. Laboratory findings of your CLD may include decreased serum 
albumin, increased International Normalized Ratio (INR), arterial 
deoxygenation (hypoxemia), increased serum creatinine, oliguria 
(reduced urine output), or sodium retention. Another laboratory 
finding that may be included in the evidence is a liver biopsy. If 
you have had a liver biopsy, we will make every reasonable effort to 
obtain the results; however, we will not purchase a liver biopsy.
    2. Manifestations of CLD.
    a. Gastrointestinal hemorrhaging (5.05A), as a consequence of 
cirrhosis and high pressure in the liver's portal venous system, may 
occur from varices (dilated veins in the esophagus or the stomach) 
or from portal hypertensive gastropathy (abnormal mucosal changes in 
the stomach). When gastrointestinal hemorrhaging is due to a cause 
other than CLD, we evaluate it under 5.02. The phrase ``consider 
under a disability for 1 year'' in 5.02 and 5.05A does not refer to 
the date on which your disability began, only to the date on which 
we must reevaluate whether your impairment(s) continues to meet a 
listing or is otherwise disabling. We determine the onset of your 
disability based on the facts of your case.
    b. Ascites or hydrothorax (5.05B) is a pathologic accumulation 
of fluid in the peritoneal cavity (ascites) or pleural space 
(hydrothorax). Ascites or hydrothorax may be diagnosed by removing 
some of the fluid with needle aspiration (paracentesis or 
thoracentesis), physical examination, or imaging. The most common 
causes of ascites are portal hypertension and low serum albumin 
resulting from CLD. We evaluate other causes of ascites and 
hydrothorax that are unrelated to CLD, such as congestive heart 
failure and cancer, under the listings in the affected body systems.
    c. Spontaneous bacterial peritonitis (SBP) (5.05C) is an acute 
bacterial infection of peritoneal fluid and is most commonly 
associated with CLD. SBP is diagnosed by laboratory analysis of 
peritoneal fluid (obtained by paracentesis) that contains a 
neutrophil count (also called absolute neutrophil count) of at least 
250 cells/mm\3\. 5.05C is satisfied with one evaluation documenting 
peritoneal infection. We evaluate other causes of peritonitis that 
are unrelated to CLD, such as tuberculosis, malignancy, and 
perforated bowel, under the listings in the affected body systems.
    d. Hepatorenal syndrome (5.05D) is renal failure associated with 
CLD in the absence of underlying kidney pathology. Findings 
associated with hepatorenal syndrome include elevation of serum 
creatinine, sodium retention with low urinary sodium excretion, and 
oliguria. We evaluate renal dysfunction with known underlying kidney 
pathology, such as glomerulonephritis, tubular necrosis, and renal 
infections, under the listings in 6.00.
    e. Hepatopulmonary syndrome (5.05E) is arterial deoxygenation 
due to intrapulmonary vascular dilation and arteriovenous shunting 
associated with CLD. Clinical findings of hepatopulmonary syndrome 
include platypnea (shortness of breath relieved when lying down) and 
orthodeoxia (low arterial blood oxygen while in the upright 
position), when presenting in the context of CLD. We evaluate 
pulmonary dysfunction with known underlying respiratory pathology, 
such as asthma, pneumonia, and pulmonary infections, under the 
listings in 3.00.
    (i) Under 5.05E1, we require a resting arterial blood gas (ABG) 
measurement obtained while you are breathing room air; that is, 
without oxygen supplementation. The ABG report must include the 
PaO2 value, your name, the date of the test, 
and either the altitude or both the city and State of the test site.
    (ii) We will not purchase the specialized imaging techniques 
described in 5.05E2; however, if you have had the test(s) at a time 
relevant to your claim, we will make every reasonable effort to 
obtain the report.
    f. Hepatic encephalopathy (5.05F), also known as portosystemic 
encephalopathy, is a recurrent or chronic neuropsychiatric disorder 
associated with CLD.
    (i) Under 5.05F2, we require documentation of a mental 
impairment associated with hepatic encephalopathy. A mental 
impairment can include abnormal behavior, changes in mental status, 
or an altered state of consciousness. Reports of abnormal behavior 
may show that you are experiencing delusions, paranoia, or 
hallucinations. Reports of changes in mental status may show change 
in sleep patterns, personality or mood changes, poor concentration, 
or poor judgment or cognitive dysfunction (for example, impaired 
memory, poor problem-solving ability, or attention deficits). 
Reports of altered state of consciousness may show that you are 
experiencing confusion, delirium, or stupor.
    (ii) Signs and laboratory findings that document the severity of 
hepatic encephalopathy when not attributable to other causes may 
include a ``flapping tremor'' (asterixis), characteristic 
abnormalities found on an electroencephalogram (EEG), or abnormal 
serum albumin or coagulation values. We will not purchase an EEG; 
however, if you have had this test at a time relevant to your claim, 
we will make every reasonable effort to obtain the report for the

[[Page 37733]]

purpose of establishing whether your impairment meets the criteria 
of 5.05F.
    (iii) We will not evaluate acute encephalopathy under 5.05F if 
it results from conditions other than CLD. For example, we will 
evaluate acute encephalopathy caused by vascular events under the 
listings in 11.00 and acute encephalopathy caused by cancer under 
the listings in 13.00.
    3. SSA Chronic Liver Disease (SSA CLD) score (5.05G). Listing 
5.05G requires two SSA CLD scores, each requiring three or four 
laboratory values. The ``date of the SSA CLD score'' is the date of 
the earliest of the three or four laboratory values used for its 
calculation. The date of the second SSA CLD score must be at least 
60 days after the date of the first SSA CLD score and both scores 
must be within the required 12-month period. If you have the two SSA 
CLD scores required by 5.05G, we will find that your impairment 
meets the criteria of the listing from at least the date of the 
first SSA CLD score.
    a. We calculate the SSA CLD score using a formula that includes 
up to four laboratory values: Serum creatinine (mg/dL), total 
bilirubin (mg/dL), INR, and under certain conditions, serum sodium 
(mmol/L). The SSA CLD score calculation contains at least one, and 
sometimes two, parts, as described in (i) and (ii).
    (i) The initial calculation is:

SSA CLDi =
9.57 x [loge(serum creatinine mg/dL)]
+ 3.78 x [loge(serum total bilirubin mg/dL)]
+11.2 x [loge(INR)]
+ 6.43
rounded to the nearest whole integer.

    (ii) If the value from the initial calculation is 11 or below, 
the SSA CLD score will be the SSA CLDi value. If the 
value from the initial calculation is greater than 11, the SSA CLD 
score will be re-calculated as:

SSA CLD =
SSA CLDi
+ 1.32 x (137-serum sodium mmol/L)
-[0.033 x SSA CLDi x (137-serum sodium mmol/L)]

    (iii) We round the results of your SSA CLD score calculation to 
the nearest whole integer to arrive at your SSA CLD score.
    b. For any SSA CLD score calculation, all of the required 
laboratory values (serum creatinine, serum total bilirubin, INR, and 
serum sodium) must have been obtained within a continuous 30-day 
period.
    (i) We round values for serum creatinine (mg/dL), serum total 
bilirubin (mg/dL), or INR less than 1.0 up to 1.0 to calculate your 
SSA CLD score.
    (ii) We round values for serum creatinine (mg/dL) greater than 
4.0 down to 4.0 to calculate your SSA CLD score.
    (iii) If there are multiple laboratory values within the 30-day 
interval for serum creatinine (mg/dL), serum total bilirubin (mg/
dL), or INR, we use the highest value to calculate your SSA CLD 
score. We will not use any INR values derived from testing done 
while you are on anticoagulant treatment in our SSA CLD calculation.
    (iv) If there are multiple laboratory values within the 30-day 
interval for serum sodium (mmol/L), we use the lowest value to 
calculate your SSA CLD score.
    (v) If you are in renal failure or on renal dialysis within a 
week of any serum creatinine test in the period used for the SSA CLD 
calculation, we will use a serum creatinine value of 4.0, which is 
the maximum serum creatinine level allowed in the calculation, to 
calculate your SSA CLD score.
    (vi) If your serum sodium is less than 125 mmol/L, we will set 
your serum sodium to 125 mmol/L for purposes of calculation of the 
SSA CLD score. If your serum sodium is higher than 137 mmol/L, we 
will set your serum sodium to 137 mmol/L for purposes of calculation 
of the SSA CLD score.
    c. When we indicate ``loge'' (also abbreviated 
``ln'') in the formula for the SSA CLD score calculation, we mean 
the ``base e logarithm'' or ``natural logarithm'' of the numerical 
laboratory value, not the ``base 10 logarithm'' or ``common 
logarithm'' (log) of the laboratory value, and not the actual 
laboratory value. For example, if a person has laboratory values of 
serum creatinine 1.4 mg/dL, serum total bilirubin 1.3 mg/dL, INR 
1.32, and serum sodium 119 mmol/L, we compute the SSA CLD score as 
follows:

SSA CLDi =
9.57 x [loge(serum creatinine 1.4 mg/dL) = 0.336]
+ 3.78 x [loge(serum total bilirubin 1.3 mg/dL) = 0.262]
+ 11.2 x [loge(INR 1.32) = .278]
+ 6.43
= 3.22 + 0.99 + 3.11 + 6.43
= 13.75, which we round to an SSA CLDi score of 14.

    Because the SSA CLDi score is over 11, we then move 
to the second step of calculating the SSA CLD:

SSA CLD = 14
+ 1.32 x (137-serum sodium 125 mmol/L)
-[0.033 x SSA CLDi 14 x (137-serum sodium 125 mmol/L)
= 14 + 15.84-5.54
= 24.3, which we round to an SSA CLD score of 24.

    D. What is inflammatory bowel disease (IBD), and how do we 
evaluate it under 5.06?
    1. IBD is a group of inflammatory conditions of the small 
intestine and colon. The most common IBD disorders are Crohn's 
disease and ulcerative colitis. Remissions and exacerbations of 
variable duration are a hallmark of IBD.
    2. We evaluate your signs and symptoms of IBD, such as diarrhea, 
fecal incontinence, rectal bleeding, abdominal pain, fatigue, fever, 
nausea, vomiting, arthralgia, abdominal tenderness, palpable 
abdominal mass (usually inflamed loops of bowel), and perianal 
disease (for example, fissure, fistulas, abscesses, or anal canal 
stenosis), when we assess the severity of your impairment(s). You 
may require supplemental daily nutrition due to IBD. There are two 
forms of supplemental daily nutrition we consider under 5.06B5: 
enteral nutrition (delivered directly to a part of your digestive 
system) via a gastrostomy, duodenostomy, or jejunostomy, and 
parenteral nutrition delivered via a central venous catheter. 
Enteral tube feedings delivered via nasal or oral tubes do not 
satisfy the requirement in 5.06B5.
    3. Surgical diversion of the intestinal tract, including 
ileostomy and colostomy, does not preclude the ability to perform 
any gainful activity if you are able to maintain adequate nutrition 
and function of the stoma. However, if you are not able to maintain 
adequate nutrition, we will evaluate your impairment under 5.08.
    4. IBD may also be associated with significant extraintestinal 
manifestations in a variety of body systems. These include, but are 
not limited to, involvement of the eye (for example, uveitis, 
episcleritis, or iritis); hepatobiliary disease (for example, 
gallstones or primary sclerosing cholangitis); urologic disease (for 
example, kidney stones or obstructive hydronephrosis); skin 
involvement (for example, erythema nodosum or pyoderma gangrenosum); 
or non-destructive inflammatory arthritis. You may also have 
associated thromboembolic disorders or vascular disease. These 
manifestations may not correlate with the severity of your IBD. If 
your impairment does not meet any of the criteria of 5.06, we will 
consider the effects of your extraintestinal manifestations in 
determining whether you have an impairment(s) that meets or 
medically equals another listing, and when we assess your residual 
functional capacity.
    5. Repeated complications of IBD.
    a. Examples of complications of IBD include abscesses, 
intestinal perforation, toxic megacolon, infectious colitis, 
pyoderma gangrenosum, ureteral obstruction, primary sclerosing 
cholangitis, and hypercoagulable state (which may lead to thromboses 
or embolism). When we evaluate repeated complications of IBD, we 
consider all relevant information in your case record to determine 
the effects of your IBD on your ability to function independently, 
appropriately, effectively, and on a sustained basis. Factors we 
consider include, but are not limited to: your symptoms, the 
frequency and duration of your complications, periods of 
exacerbation and remission, and the functional effects of your 
treatment, including the side effects of your medication. Your 
impairment will satisfy this criterion regardless of whether you 
have the same kind of complication repeatedly, all different 
complications, or any other combination of complications; for 
example, two of the same kind of complication and a different one.
    b. To satisfy the requirements described under 5.06C, your IBD 
must result in repeated complications and marked limitation in one 
of three areas of functioning: activities of daily living; 
maintaining social functioning; or completing tasks in a timely 
manner due to deficiencies in concentration, persistence, or pace. 
If the complications do not last as long or occur as frequently as 
required under 5.06C, we will consider whether your IBD medically 
equals the listing.
    c. Marked limitation means that the signs and symptoms of your 
IBD interfere seriously with your ability to function. Although we 
do not require the use of such a scale, ``marked'' would be the 
fourth point on a five-point rating scale consisting of no 
limitation, mild limitation, moderate limitation, marked limitation, 
and extreme limitation. We do not define ``marked'' by a specific 
number of

[[Page 37734]]

activities of daily living or different behaviors in which your 
social functioning is impaired, or a specific number of tasks that 
you are able to complete, but by the nature and overall degree of 
interference with your functioning. You may have marked limitation 
when several activities or functions are impaired, or when only one 
is impaired. Additionally, you need not be totally precluded from 
performing an activity to have marked limitation, as long as the 
degree of limitation interferes seriously with your ability to 
function independently, appropriately, and effectively. The term 
``marked'' does not imply that you must be confined to bed, 
hospitalized, or in a nursing home.
    d. Activities of daily living include, but are not limited to, 
such activities as doing household chores, grooming and hygiene, 
using a post office, taking public transportation, or paying bills. 
We will find that you have ``marked'' limitation in activities of 
daily living if you have a serious limitation in your ability to 
maintain a household or take public transportation because of 
symptoms, such as pain, severe fatigue, anxiety, or difficulty 
concentrating, caused by your IBD (including complications of the 
disorder) or its treatment, even if you are able to perform some 
self-care activities.
    e. Maintaining social functioning includes the capacity to 
interact independently, appropriately, effectively, and on a 
sustained basis with others. It includes the ability to communicate 
effectively with others. We will find that you have ``marked'' 
limitation in maintaining social functioning if you have a serious 
limitation in social interaction on a sustained basis because of 
symptoms, such as pain, severe fatigue, anxiety, or difficulty 
concentrating, or a pattern of exacerbation and remission, caused by 
your IBD (including complications of the disorder) or its treatment, 
even if you are able to communicate with close friends or relatives.
    f. Completing tasks in a timely manner due to deficiencies in 
concentration, persistence, or pace involves the ability to sustain 
concentration, persistence, or pace to permit timely completion of 
tasks commonly found in work settings. We will find that you have 
``marked'' limitation in completing tasks if you have a serious 
limitation in your ability to sustain concentration or pace adequate 
to complete work-related tasks because of symptoms, such as pain, 
severe fatigue, anxiety, or difficulty concentrating, caused by your 
IBD (including complications of the disorder) or its treatment, even 
if you are able to do some routine activities of daily living.
    E. What is intestinal failure, and how do we evaluate it under 
5.07?
    1. Intestinal failure is a condition resulting in gut function 
below the minimum necessary for the absorption of macronutrients or 
water and electrolytes, resulting in a requirement for intravenous 
supplementation (i.e., parenteral nutrition) to maintain health. 
Examples of conditions that may result in intestinal failure include 
short bowel syndrome, extensive small bowel mucosal disease, and 
chronic motility disorders.
    2. Short bowel syndrome is a malabsorption disorder that occurs 
when ischemic vascular insults (caused, for example, by volvulus or 
necrotizing enterocolitis), trauma, or IBD complications require(s) 
surgical resection of any amount of the small intestine, resulting 
in chronic malnutrition.
    3. Extensive small bowel mucosal disease means that the mucosal 
surface of the small bowel does not efficiently absorb nutrients or 
loses nutrients. Common causes of small bowel mucosal disease 
include microvillous inclusion disease and tufting enteropathy.
    4. Chronic motility disorder refers to a chronic disorder of the 
propulsion of gut content without fixed obstructions, causing 
intolerance to oral nutrition and inadequate nutritional intake. 
This type of disorder may also be known as a chronic intestinal 
pseudo-obstruction (CIPO), because the gut dysfunction mimics that 
of an obstructed intestine, but without evidence of an actual 
obstruction. Primary CIPO may have an unknown underlying cause. 
Chronic motility disorders may also result from congenital, 
neuromuscular, or autoimmune conditions, such as gastroschisis, 
omphalocele, long segment Hirschprung's disease, Crohn's disease, 
and mitochondrial disorders.
    5. For short bowel syndrome, we require a copy of the operative 
report that includes details of the surgical findings, or 
postoperative imaging indicating a resection of the small intestine. 
If we cannot get one of these reports, we need other medical reports 
that include details of the surgical findings. For other chronic 
motility disorders or extensive small bowel mucosal disease, we need 
medical reports that include details of your intestinal dysfunction. 
For any impairment evaluated under 5.07, we also need medical 
documentation that you are dependent on daily parenteral nutrition 
to provide most of your nutritional requirements.
    F. How do we evaluate weight loss due to any digestive disorder 
under 5.08?
    1. In addition to the impairments specifically mentioned in 
these listings, other digestive disorders, such as esophageal 
stricture, pancreatic insufficiency, and malabsorption, may result 
in significant weight loss. Impairments other than digestive 
disorders that cause weight loss should be evaluated under the 
appropriate body system for that impairment. For instance, weight 
loss as a result of chronic kidney disease should be evaluated under 
our rules for genitourinary disorders (see 6.00), and weight loss as 
the result of an eating disorder should be evaluated under our rules 
for mental disorders (see 12.00). However, if you develop a 
digestive disorder as the result of your other impairment, we will 
evaluate the acquired digestive disorder under our rules for 
digestive disorders. We evaluate weight loss due to any digestive 
disorder under 5.08 by using the body mass index (BMI).
    2. BMI is the ratio of your weight to the square of your height. 
Calculation and interpretation of the BMI are independent of gender 
in adults.
    a. We calculate BMI using inches and pounds, meters and 
kilograms, or centimeters and kilograms. We must have measurements 
of your weight and height without shoes for these calculations.
    b. We calculate BMI using one of the following formulas:

English Formula
BMI = [Weight in Pounds/(Height in Inches x Height in Inches)] x 703
Metric Formulas
BMI = Weight in Kilograms/(Height in Meters x Height in Meters)
BMI = [Weight in Kilograms/(Height in Centimeters x Height in 
Centimeters)] x 10,000

    G. How do we evaluate digestive organ transplantation? If you 
receive a liver (5.09), small intestine (5.11), or pancreas (5.12) 
transplant, we will consider you disabled under the listing for 1 
year from the date of the transplant. After that, we evaluate your 
residual impairment(s) by considering the adequacy of your post-
transplant function, the frequency and severity of any rejection 
episodes you have, complications in other body systems, and adverse 
treatment effects. People who receive digestive organ transplants 
generally have impairments that meet our definition of disability 
before they undergo transplantation. The phrase ``consider under a 
disability for 1 year'' in 5.09, 5.11, and 5.12 does not refer to 
the date on which your disability began, only to the date on which 
we must reevaluate whether your impairment(s) continues to meet a 
listing or is otherwise disabling. We determine the onset of your 
disability based on the facts of your case.
    H. How do we evaluate your digestive disorder if there is no 
record of ongoing treatment? If there is no record of ongoing 
treatment despite the existence of a severe impairment(s), we will 
assess the severity and duration of your digestive disorder based on 
the current medical and other evidence in your case record. If there 
is no record of ongoing treatment, you may not be able to show an 
impairment that meets a digestive disorders listing, but your 
impairment may medically equal a listing, or be disabling based on 
consideration of your residual functional capacity, age, education, 
and work experience.
    I. How do we evaluate your digestive disorder if there is 
evidence establishing a substance use disorder? If we find that you 
are disabled and there is medical evidence in your case record 
establishing that you have a substance use disorder, we will 
determine whether your substance use disorder is a contributing 
factor material to the determination of disability. See Sec. Sec.  
404.1535 and 416.935 of this chapter. Digestive disorders resulting 
from drug or alcohol use are often chronic in nature and will not 
necessarily improve with cessation in drug or alcohol use.
    J. How do we evaluate digestive disorders that do not meet one 
of these listings?
    1. These listings are only examples of common digestive 
disorders that we consider severe enough to prevent you from doing 
any gainful activity. If your impairment(s) does not meet the 
criteria of any of these listings, we must also consider whether you 
have an impairment(s) that satisfies the criteria of a listing in 
another body system.
    2. If you have a severe medically determinable impairment(s) 
that does not meet a listing, we will determine whether

[[Page 37735]]

your impairment(s) medically equals a listing. See Sec. Sec.  
404.1526 and 416.926 of this chapter. Digestive disorders may be 
associated with disorders in other body systems, and we consider the 
combined effects of multiple impairments when we determine whether 
they medically equal a listing. If your impairment(s) does not meet 
or medically equal a listing, you may or may not have the residual 
functional capacity to engage in substantial gainful activity. We 
proceed to the fourth step and, if necessary, the fifth step of the 
sequential evaluation process in Sec. Sec.  404.1520 and 416.920 of 
this chapter. We use the rules in Sec. Sec.  404.1594 and 416.994 of 
this chapter, as appropriate, when we decide whether you continue to 
be disabled.
    5.01 Category of Impairments, Digestive Disorders
    5.02 Gastrointestinal hemorrhaging from any cause, requiring 
three blood transfusions of at least 2 units of blood per 
transfusion, within a consecutive 12-month period and at least 30 
days apart. Consider under a disability for 1 year following the 
last documented transfusion; after that, evaluate the residual 
impairment(s).
    5.03-5.04 [Reserved]
    5.05 Chronic liver disease (CLD) (see 5.00C) with A, B, C, D, E, 
F, or G:
    A. Hemorrhaging from esophageal, gastric, or ectopic varices, or 
from portal hypertensive gastropathy (see 5.00C2a), documented by 
imaging (see 5.00B3); resulting in 1 and 2:
    1. Hemodynamic instability indicated by signs such as pallor 
(pale skin), diaphoresis (profuse perspiration), rapid pulse, low 
blood pressure, postural hypotension (pronounced fall in blood 
pressure when arising to an upright position from lying down), or 
syncope (fainting); and
    2. Requiring hospitalization for transfusion of at least 2 units 
of blood. Consider under a disability for 1 year following the 
documented transfusion; after that, evaluate the residual 
impairment(s).

OR

    B. Ascites or hydrothorax not attributable to other causes (see 
5.00C2b), present on 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:
    1. Paracentesis; or
    2. Thoracentesis; or
    3. Imaging or physical examination with a or b:
    a. Serum albumin of 3.0 g/dL or less; or
    b. INR of at least 1.5.

OR

    C. Spontaneous bacterial peritonitis (see 5.00C2c) documented by 
peritoneal fluid containing a neutrophil count of at least 250 
cells/mm\3\.

OR

    D. Hepatorenal syndrome (see 5.00C2d) documented by 1, 2, or 3:
    1. Serum creatinine elevation of at least 2 mg/dL; or
    2. Oliguria with 24-hour urine output less than 500 mL; or
    3. Sodium retention with urine sodium less than 10 mEq per 
liter.

OR

    E. Hepatopulmonary syndrome (see 5.00C2e) documented by 1 or 2:
    1. Arterial PaO2 measured by an ABG test, 
while at rest, breathing room air, less than or equal to:
    a. 60 mm Hg, at test sites less than 3,000 feet above sea level; 
or
    b. 55 mm Hg, at test sites from 3,000 through 6,000 feet above 
sea level; or
    c. 50 mm Hg, at test sites over 6,000 feet above sea level; or
    2. Intrapulmonary arteriovenous shunting as shown by contrast-
enhanced echocardiography or macroaggregated albumin lung perfusion 
scan.

OR

    F. Hepatic encephalopathy (see 5.00C2f) with documentation of 
abnormal behavior, cognitive dysfunction, changes in mental status, 
or altered state of consciousness (for example, confusion, delirium, 
stupor, or coma), present on two evaluations within a consecutive 
12-month period and at least 60 days apart and either 1 or 2:
    1. History of transjugular intrahepatic portosystemic shunt 
(TIPS) or other surgical portosystemic shunt; or
    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:
    a. Asterixis or other fluctuating physical neurological 
abnormalities; or
    b. EEG demonstrating triphasic slow wave activity; or
    c. Serum albumin of 3.0 g/dL or less; or
    d. INR of 1.5 or greater.

OR

    G. Two SSA CLD scores (see 5.00C3) of at least 20 within a 
consecutive 12-month period and at least 60 days apart. Consider 
under a disability from at least the date of the first score.
    5.06 Inflammatory bowel disease (IBD) (see 5.00D) documented by 
endoscopy, biopsy, imaging, or operative findings, and demonstrated 
by A, B, or C:
    A. Obstruction of stenotic areas (not adhesions) in the small 
intestine or colon with proximal dilatation, confirmed by imaging or 
in surgery, requiring two hospitalizations for 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:
    1. Anemia with hemoglobin of less than 10.0 g/dL, present on at 
least two evaluations at least 60 days apart; or
    2. Serum albumin of 3.0 g/dL or less, present on at least two 
evaluations at least 60 days apart; or
    3. Clinically documented tender abdominal mass palpable on 
physical examination with abdominal pain or cramping; or
    4. Perianal disease with a draining abscess or fistula; or
    5. Need for supplemental daily enteral nutrition via a 
gastrostomy, duodenostomy, or jejunostomy, or daily parenteral 
nutrition via a central venous catheter.

OR

    C. Repeated complications of IBD (see 5.00D5a), occurring an 
average of 3 times a year, or once every 4 months, each lasting 2 
weeks or more, within a consecutive 12-month period, and marked 
limitation (see 5.00D5c) in one of the following:
    1. Activities of daily living (see 5.00D5d); or
    2. Maintaining social functioning (see 5.00D5e); or
    3. Completing tasks in a timely manner due to deficiencies in 
concentration, persistence, or pace (see 5.00D5f).
    5.07 Intestinal failure (see 5.00E) due to short bowel syndrome, 
chronic motility disorders, or extensive small bowel mucosal 
disease, resulting in dependence on daily parenteral nutrition via a 
central venous catheter for at least 12 months.
    5.08 Weight loss due to any digestive disorder (see 5.00F), 
despite adherence to prescribed medical treatment, with BMI of less 
than 17.50 calculated on at least two evaluations at least 60 days 
apart within a consecutive 12-month period.
    5.09 Liver transplantation (see 5.00G). Consider under a 
disability for 1 year from the date of the transplant; after that, 
evaluate the residual impairment(s).
    5.10 [Reserved]
    5.11 Small intestine transplantation (see 5.00G). Consider under 
a disability for 1 year from the date of the transplant; after that, 
evaluate the residual impairment(s).
    5.12 Pancreas transplantation (see 5.00G). Consider under a 
disability for 1 year from the date of the transplant; after that, 
evaluate the residual impairment(s).

6.00 Genitourinary Disorders

* * * * *
    C. * * *
    7. Anorexia (diminished appetite) with weight loss. Anorexia is 
a frequent sign of CKD and can result in weight loss. We will use 
body mass index (BMI) to determine the severity of your weight loss 
under 6.05B4. (BMI is the ratio of your measured weight to the 
square of your measured height.) We calculate your BMI using the 
formulas in the digestive disorders body system (5.00).
* * * * *

8.00 Skin Disorders

    A. Which skin disorders do we evaluate under these listings? We 
use these listings to evaluate skin disorders that result from 
hereditary, congenital, or acquired pathological processes. We 
evaluate genetic photosensitivity disorders (8.07), burns (8.08), 
and chronic conditions of the skin or mucous membranes such as 
ichthyosis, bullous disease, dermatitis, psoriasis, and hidradenitis 
suppurativa (8.09) under these listings.
    B. What are our definitions for the following terms used in this 
body system?
    1. Assistive device(s): An assistive device, for the purposes of 
these listings, is any device used to improve stability, dexterity, 
or mobility. An assistive device can be hand-held, such as a 
cane(s), a crutch(es), or a walker; used in a seated position, such 
as a wheelchair, rollator, or power operated

[[Page 37736]]

vehicle; or worn, such as a prosthesis or an orthosis.
    2. Chronic skin lesions: Chronic skin lesions can have recurrent 
exacerbations (see 8.00B7). They can occur despite prescribed 
medical treatment. These chronic skin lesions can develop on any 
part of your body, including upper extremities, lower extremities, 
palms of your hands, soles of your feet, the perineum, inguinal 
(groin) region, and axillae (underarms). Chronic skin lesions may 
result in functional limitations as described in 8.00D2.3. 
Contractures: Contractures are permanent fibrous scar tissue 
resulting in tightening and thickening of skin that prevents normal 
movement of the damaged area. They can develop on any part of your 
musculoskeletal system, including upper extremities, lower 
extremities, palms of your hands, soles of your feet, the perineum, 
inguinal (groin) region, and axillae (underarms). Contractures may 
result in functional limitations as described in 8.00D2.
    4. Documented medical need: When we use the term ``documented 
medical need,'' we mean that there is evidence (see Sec. Sec.  
404.1513 and 416.913 of this chapter) from your medical source(s) in 
the medical record that supports your need for an assistive device 
(see 8.00B1) for a continuous period of at least 12 months. The 
evidence must include documentation from your medical source(s) 
describing any limitation(s) in your upper or lower extremity 
functioning that supports your need for the assistive device and 
describing the circumstances for which you need it. The evidence 
does not have to include a specific prescription for the device.
    5. Fine and gross movements: Fine movements, for the purposes of 
these listings, involve use of your wrists, hands, and fingers; such 
movements include picking, pinching, manipulating, and fingering. 
Gross movements involve use of your shoulders, upper arms, forearms, 
and hands; such movements include handling, gripping, grasping, 
holding, turning, and reaching. Gross movements also include 
exertional activities such as lifting, carrying, pushing, and 
pulling.
    6. Surgical management: For the purposes of these listings, 
surgical management includes the surgery(ies) itself, as well as 
various post-surgical procedures, surgical complications, infections 
or other medical complications, related illnesses, or related 
treatments that delay a person's attainment of maximum benefit from 
surgery.
    7. Exacerbation: For the purposes of these listings, 
exacerbation means an increase in the signs or symptoms of the skin 
disorder. Exacerbation may also be referred to as flare, flare-up, 
or worsening of the skin disorder.
    C. What evidence do we need to evaluate your skin disorder?
    1. To establish the presence of a skin disorder as a medically 
determinable impairment, we need objective medical evidence from an 
acceptable medical source (AMS) who has examined you for the 
disorder.
    2. We will make every reasonable effort to obtain your medical 
history, treatment records, and relevant laboratory findings, but we 
will not purchase genetic testing.
    3. When we evaluate the presence and severity of your skin 
disorder(s), we generally need information regarding:
    a. The onset, duration, and frequency of exacerbations (see 
8.00B7);
    b. The prognosis of your skin disorder;
    c. The location, size, and appearance of lesions and 
contractures;
    d. Any available history of familial incidence;
    e. Your exposure to toxins, allergens or irritants; seasonal 
variations; and stress factors;
    f. Your ability to function outside of a highly protective 
environment (see 8.00E4);
    g. Laboratory findings (for example, a biopsy obtained 
independently of Social Security disability evaluation or results of 
blood tests);
    h. Evidence from other medically acceptable methods consistent 
with the prevailing state of medical knowledge and clinical 
practice; and
    i. Statements you or others make about your disorder(s), your 
restrictions, and your daily activities.
    D. How do we evaluate the severity of skin disorders?
    1. General. We evaluate the severity of skin disorders based on 
the site(s) of your chronic skin lesions (see 8.00B2) or 
contractures (see 8.00B3), functional limitations caused by your 
signs and symptoms (including pain) (see 8.00D2), and how your 
prescribed treatment affects you. We consider the frequency and 
severity of your exacerbations (see 8.00B7), how quickly they 
resolve, and how you function between exacerbations (see 8.00B7), to 
determine whether your skin disorder meets or medically equals a 
listing (see 8.00D3). If there is no record of ongoing medical 
treatment for your disorder, we will follow the guidelines in 
8.00D6. We will determine the extent and kinds of evidence we need 
from medical and non-medical sources based on the individual facts 
about your disorder. For our basic rules on evidence, see Sec. Sec.  
404.1512, 404.1513, 404.1520b, 416.912, 416.913, and 416.920b of 
this chapter. For our rules on evaluating your symptoms, see 
Sec. Sec.  404.1529 and 416.929 of this chapter.
    2. Limitation(s) of physical functioning due to skin disorders.
    a. Skin disorders may be due to chronic skin lesions (see 
8.00B2) or contractures (see 8.00B3), and may cause pain or restrict 
movement, which can limit your ability to initiate, sustain, and 
complete work-related activities. For example, skin lesions in the 
axilla may limit your ability to raise or reach with the affected 
arm, or lesions in the inguinal region may limit your ability to 
ambulate, sit, or lift and carry. To evaluate your skin disorder(s) 
under 8.07B, 8.08, and 8.09, we require medically documented 
evidence of physical limitation(s) of functioning related to your 
disorder. The decrease in physical function must have lasted, or can 
be expected to last, for a continuous period of at least 12 months 
(see Sec. Sec.  404.1509 and 416.909 of this chapter). Xeroderma 
pigmentosum is the only skin disorder that does not include 
functional criteria because the characteristics and severity of the 
disorder itself are sufficient to meet the criteria in 8.07A.
    b. The functional criteria require impairment-related physical 
limitations in using upper or lower extremities that have lasted, or 
can be expected to last, for a continuous period of at least 12 
months, medically documented by one of the following:
    (i) Inability to use both upper extremities to the extent that 
neither can be used to independently initiate, sustain, and complete 
work-related activities involving fine and gross movements (see 
8.00B5) due to chronic skin lesions (see 8.00B2) or contractures 
(see 8.00B3); or
    (ii) Inability to use one upper extremity to independently 
initiate, sustain, and complete work-related activities involving 
fine and gross movements (see 8.00B5) due to chronic skin lesions 
(see 8.00B2) or contractures (see 8.00B3), and a documented medical 
need (see 8.00B4) for an assistive device (see 8.00B1) that requires 
the use of the other upper extremity; or
    (iii) Inability to stand up from a seated position and maintain 
an upright position to the extent needed to independently initiate, 
sustain, and complete work-related activities due to chronic skin 
lesions (see 8.00B2) or contractures (see 8.00B3) affecting at least 
two extremities (including when the limitations are due to 
involvement of the perineum or the inguinal region); or
    (iv) Inability to maintain an upright position while standing or 
walking to the extent needed to independently initiate, sustain, and 
complete work-related activities due to chronic skin lesions (see 
8.00B2) or contractures (see 8.00B3) affecting both lower 
extremities (including when the limitations are due to involvement 
of the perineum or the inguinal region).
    3. Frequency of exacerbations due to chronic skin lesions. A 
skin disorder resulting in chronic skin lesions (see 8.00B2) may 
have frequent exacerbations (see 8.00B7) severe enough to meet a 
listing even if each individual skin lesion exacerbation (see 
8.00B7) did not last for an extended amount of time. We will 
consider the frequency, severity, and duration of skin lesion 
exacerbations (see 8.00B7), how quickly they resolve, and how you 
function in the time between skin lesion exacerbations (see 8.00B7), 
to determine whether your skin disorder meets or medically equals a 
listing.
    4. Symptoms (including pain). Your symptoms may be an important 
factor in our determination of whether your skin disorder(s) meets 
or medically equals a listing, or whether you are otherwise able to 
work. We consider your symptoms only when you have a medically 
determinable impairment that could reasonably be expected to produce 
the symptoms. See Sec. Sec.  404.1529 and 416.929 of this chapter.
    5. Treatment.
    a. General. Treatments for skin disorders may have beneficial or 
adverse effects, and responses to treatment vary from person to 
person. Your skin disorder's response to treatment may vary due to 
treatment resistance or side effects that can result in functional 
limitations. We will evaluate all of the effects of treatment 
(including surgical treatment, medications, and therapy) on the 
symptoms, signs, and laboratory findings of

[[Page 37737]]

your skin disorder, and on your ability to function.
    b. Despite adherence to prescribed medical treatment for 3 
months. Under 8.09, we require that your symptoms persist ``despite 
adherence to prescribed medical treatment for 3 months.'' This 
requirement means that you must have taken prescribed medication(s) 
or followed other medical treatment prescribed by a medical source 
for 3 consecutive months. Treatment or effects of treatment may be 
temporary. In most cases, sufficient time must elapse to allow us to 
evaluate your response to treatment, including any side effects. For 
our purposes, ``sufficient time'' means a period of at least 3 
months. If your treatment has not lasted for at least 3 months, we 
will follow the rules in 8.00D6a. The 3 months adherence to 
prescribed medical treatment must be within the period of at least 
12 months that we use to evaluate severity.
    c. Treatment with PUVA (psoralen and ultraviolet A (UVA) light) 
or biologics. If you receive additional treatment with PUVA or 
biologics to treat your skin disorder(s), we will defer adjudication 
of your claim for 6 months from the start of treatment with PUVA or 
biologics to evaluate the effectiveness of these treatments unless 
we can make a fully favorable determination or decision on another 
basis.
    6. No record of ongoing treatment.
    a. Despite having a skin disorder, you may not have received 
ongoing treatment, may have just begun treatment, may not have 
access to prescribed medical treatment, or may not have an ongoing 
relationship with the medical community. In any of these situations, 
you will not have a longitudinal medical record for us to review 
when we evaluate your disorder. In some instances, we may be able to 
assess the severity and duration of your skin disorder based on your 
medical record and current evidence alone. We may ask you to attend 
a consultative examination to determine the severity and potential 
duration of your skin disorder (see Sec. Sec.  404.1519a and 
416.919a of this chapter).
    b. If, for any reason, you have not received treatment, your 
skin disorder cannot meet the criteria for 8.09. If the information 
in your case record is not sufficient to show that you have a skin 
disorder that meets the criteria of one of the skin disorders 
listings, we will follow the rules in 8.00I.
    E. How do we evaluate genetic photosensitivity disorders under 
8.07? Genetic photosensitivity disorders are disorders of the skin 
caused by an increase in the sensitivity of the skin to sources of 
ultraviolet light, including sunlight.
    1. Xeroderma pigmentosum (XP) (8.07A). XP is a genetic 
photosensitivity disorder with lifelong hypersensitivity to all 
forms of ultraviolet light. Laboratory testing confirms the 
diagnosis by documenting abnormalities in the body's ability to 
repair DNA (deoxyribonucleic acid) mutations after ultraviolet light 
exposure. Your skin disorder meets the requirements of 8.07A if you 
have clinical and laboratory findings supporting a diagnosis of XP 
(see 8.00E3).
    2. Other genetic photosensitivity disorders (8.07B). The effects 
of other genetic photosensitivity disorders may vary and may not 
persist over time. To meet the requirements of 8.07B, a genetic 
photosensitivity disorder other than XP must be established by 
clinical and laboratory findings (see 8.00C) and must result either 
in chronic skin lesions (see 8.00B2) or contractures (see 8.00B3) 
that result in functional limitations (see 8.00D2), or must result 
in the inability to function outside of a highly protective 
environment (see 8.00E4). Some genetic photosensitivity disorders 
can have very serious effects on other body systems, especially 
special senses and speech, neurological, mental, and cancer. We will 
evaluate your disorder(s) under the listings in 2.00, 11.00, 12.00, 
or 13.00, as appropriate.
    3. What evidence do we need to document that you have XP or 
another genetic photosensitivity disorder? We will make a reasonable 
effort to obtain evidence of your disorder(s), but we will not 
purchase genetic testing. When the results of genetic tests are part 
of the existing evidence in your case record, we will evaluate the 
test results with all other relevant evidence. We need the following 
clinical and laboratory findings to document that you have XP or 
another genetic photosensitivity disorder:
    a. A laboratory report of a definitive genetic test documenting 
appropriate chromosomal changes, including abnormal DNA repair or 
another DNA abnormality specific to your type of photosensitivity 
disorder, signed by an AMS; or
    b. A laboratory report of a definitive test that is not signed 
by an AMS, and a report from an AMS stating that you have undergone 
definitive genetic laboratory studies documenting appropriate 
chromosomal changes, including abnormal DNA repair or another DNA 
abnormality specific to your type of photosensitivity disorder; or
    c. If we do not have a laboratory report of a definitive test, 
we need documentation from an AMS that an appropriate laboratory 
analysis or other diagnostic method(s) confirms a positive diagnosis 
of your skin disorder. This documentation must state that you had 
the appropriate definitive laboratory test(s) for diagnosing your 
disorder and provide the results, or explain how another diagnostic 
method(s), consistent with the prevailing state of medical knowledge 
and clinical practice, established your diagnosis.
    4. Inability to function outside of a highly protective 
environment means that you must avoid exposure to ultraviolet light 
(including sunlight passing through windows and light from similar 
unshielded light sources), wear protective clothing and eyeglasses, 
and use opaque broad-spectrum sunscreens in order to avoid skin 
cancer or other serious effects.
    F. How do we evaluate burns under 8.08?
    1. Electrical, chemical, or thermal burns frequently affect 
other body systems, for example, musculoskeletal, special senses and 
speech, respiratory, cardiovascular, genitourinary, neurological, or 
mental. We evaluate burns in the same way we evaluate other 
disorders that can affect the skin and other body systems, using the 
listing for the predominant feature of your disorder. For example, 
if your soft tissue injuries resulting from burns are under surgical 
management (as defined in 8.00B6), we will evaluate your disorder 
under the listings in 1.00.
    2. We evaluate burns resulting in chronic skin lesions (see 
8.00B2) or contractures (see 8.00B3) that have been documented by an 
AMS to have reached maximum therapeutic benefit and therefore are no 
longer receiving surgical management, under 8.08. To be disabling, 
these burns must result in functional limitation(s) (see 8.00D2) 
that has lasted or can be expected to last for a continuous period 
of at least 12 months.
    G. How do we evaluate chronic conditions of the skin or mucous 
membranes under 8.09? We evaluate skin disorders that result in 
chronic skin lesions (see 8.00B2) or contractures (see 8.00B3) under 
8.09. These disorders must result in chronic skin lesions (see 
8.00B2) or contractures (see 8.00B3) that continue to persist 
despite adherence to prescribed medical treatment for 3 months (see 
8.00D5b) and cause functional limitations (see 8.00D2). Examples of 
skin disorders evaluated under this listing are ichthyosis, bullous 
diseases (such as pemphigus, epidermolysis bullosa, and dermatitis 
herpetiformis), chronic skin infections, dermatitis, psoriasis, and 
hidradenitis suppurativa.
    H. How do we evaluate disorders in other body systems that 
affect the skin? When your disorder(s) in another body system 
affects your skin, we first evaluate the predominant feature of your 
disorder(s) under the appropriate body system. Examples of disorders 
in other body systems that may affect the skin include the 
following:
    1. Diabetes mellitus. Diabetes mellitus that is not well 
controlled, despite treatment, can cause chronic hyperglycemia 
resulting in serious, long-lasting or recurrent exacerbations (see 
8.00B7) or complications. We evaluate those exacerbations (see 
8.00B7) or complications under the affected body system(s). If the 
complication involves soft tissue or amputation(s), we evaluate 
these features under the listings in 1.00. If the exacerbations (see 
8.00B7) or complications involve chronic bacterial or fungal skin 
lesions resulting from diabetes mellitus, we evaluate your 
limitations from the skin disorder under listing 8.09.
    2. Tuberous sclerosis. The predominant functionally limiting 
features of tuberous sclerosis are seizures and intellectual 
disorder or other mental disorders. We evaluate these features under 
the listings in 11.00 or 12.00, as appropriate.
    3. Malignant tumors of the skin. Malignant tumors of the skin 
(for example, malignant melanomas) are cancers, or malignant 
neoplastic diseases, that we evaluate under the listings in 13.00.
    4. Immune system disorders. We evaluate skin manifestations of 
immune system disorders such as systemic lupus erythematosus, 
scleroderma, psoriasis, and human immunodeficiency virus (HIV) 
infection under the listings in 14.00.
    5. Head or facial disfigurement or deformity, and other physical 
deformities caused by skin disorders. A head or facial disfigurement 
or deformity may result in loss of your sight, hearing, speech, or 
ability to chew. In addition to head and facial disfigurement and 
deformity, other physical

[[Page 37738]]

deformities may result in associated psychological problems (for 
example, depression). We evaluate the effects of head or facial 
disfigurement or deformity, or other physical deformities caused by 
skin disorders under the listings in 1.00, 2.00, 5.00, or 12.00, as 
appropriate.
    I. How do we evaluate skin disorders that do not meet one of 
these listings?
    1. These listings are only examples of common skin disorders 
that we consider severe enough to prevent you from doing any gainful 
activity. If your impairment(s) does not meet the criteria of any of 
these listings, we must also consider whether you have an 
impairment(s) that satisfies the criteria of a listing in another 
body system.
    2. If you have a severe medically determinable impairment(s) 
that does not meet a listing, we will determine whether your 
impairment(s) medically equals a listing. See Sec. Sec.  404.1526 
and 416.926 of this chapter. If your impairment(s) does not meet or 
medically equal a listing, you may or may not have the residual 
functional capacity to engage in substantial gainful activity. We 
proceed to the fourth step and, if necessary, the fifth step of the 
sequential evaluation process in Sec. Sec.  404.1520 and 416.920 of 
this chapter. We use the rules in Sec. Sec.  404.1594 and 416.994 of 
this chapter, as appropriate, when we decide whether you continue to 
be disabled.
    8.01 Category of Impairments, Skin Disorders
    8.02-8.06 [Reserved]
    8.07 Genetic photosensitivity disorders, established as 
described in 8.00E. The requirements of this listing are met if 
either paragraph A or paragraph B is satisfied.
    A. Xeroderma pigmentosum (see 8.00E1).

OR

    B. Other genetic photosensitivity disorders (see 8.00E2) with 
either 1 or 2:
    1. Chronic skin lesions (see 8.00B2) or contractures (see 
8.00B3) that cause an inability to function outside of a highly 
protective environment (see 8.00E4); or
    2. Chronic skin lesions (see 8.00B2) or contractures (see 
8.00B3) causing chronic pain or other physical limitation(s) that 
result in impairment-related functional limitations (see 8.00D2), as 
evidenced by:
    a. Inability to use both upper extremities to the extent that 
neither can be used to independently initiate, sustain, and complete 
work-related activities involving fine and gross movements (see 
8.00B5) due to chronic skin lesions (see 8.00B2) or contractures 
(see 8.00B3); or
    b. Inability to use one upper extremity to independently 
initiate, sustain, and complete work-related activities involving 
fine and gross movements (see 8.00B5) due to chronic skin lesions 
(see 8.00B2) or contractures (see 8.00B3), and a documented medical 
need (see 8.00B4) for an assistive device (see 8.00B1) that requires 
the use of the other upper extremity; or
    c. Inability to stand up from a seated position and maintain an 
upright position to the extent needed to independently initiate, 
sustain, and complete work-related activities due to chronic skin 
lesions (see 8.00B2) or contractures (see 8.00B3) affecting at least 
two extremities (including when the 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, due to chronic skin lesions (see 
8.00B2) or contractures (see 8.00B3) affecting both lower 
extremities (including when the limitations are due to involvement 
of the perineum or the inguinal region).
    8.08 Burns (see 8.00F). Burns that do not require continuing 
surgical management (see 8.00B6), or that have been documented by an 
acceptable medical source to have reached maximum therapeutic 
benefit and therefore are no longer receiving surgical management, 
resulting in chronic skin lesions (see 8.00B2) or contractures (see 
8.00B3) causing chronic pain or other physical limitation(s) that 
result in impairment-related functional limitations (see 8.00D2), as 
evidenced by:
    A. Inability to use both upper extremities to the extent that 
neither can be used to independently initiate, sustain, and complete 
work-related activities involving fine and gross movements (see 
8.00B5) due to chronic skin lesions (see 8.00B2) or contractures 
(see 8.00B3).

OR

    B. Inability to use one upper extremity to independently 
initiate, sustain, and complete work-related activities involving 
fine and gross movements (see 8.00B5) due to chronic skin lesions 
(see 8.00B2) or contractures (see 8.00B3), and a documented medical 
need (see 8.00B4) for an assistive device (see 8.00B1) that requires 
the use of the other upper extremity.

OR

    C. Inability to stand up from a seated position and maintain an 
upright position to the extent needed to independently initiate, 
sustain, and complete work-related activities due to chronic skin 
lesions (see 8.00B2) or contractures (see 8.00B3) affecting at least 
two extremities (including when the 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 due to chronic skin lesions (see 
8.00B2) or contractures (see 8.00B3) affecting both lower 
extremities (including when the limitations are due to involvement 
of the perineum or the inguinal region).
    8.09 Chronic conditions of the skin or mucous membranes (see 
8.00G) resulting in:
    A. Chronic skin lesions (see 8.00B2) or contractures (see 
8.00B3) causing chronic pain or other physical limitation(s) that 
persist despite adherence to prescribed medical treatment for 3 
months (see 8.00D5b).

AND

    B. Impairment-related functional limitations (see 8.00D2) 
demonstrated by 1, 2, 3, or 4:
    1. Inability to use both upper extremities to the extent that 
neither can be used to independently initiate, sustain, and complete 
work-related activities involving fine and gross movements (see 
8.00B5) due to chronic skin lesions (see 8.00B2) or contractures 
(see 8.00B3); or
    2. Inability to use one upper extremity to independently 
initiate, sustain, and complete work-related activities involving 
fine and gross movements (see 8.00B5) due to chronic skin lesions 
(see 8.00B2) or contractures (see 8.00B3), and a documented medical 
need (see 8.00B4) for an assistive device (see 8.00B1) that requires 
the use of the other upper extremity; or
    3. Inability to stand up from a seated position and maintain an 
upright position to the extent needed to independently initiate, 
sustain, and complete work-related activities due to chronic skin 
lesions (see 8.00B2) or contractures (see 8.00B3) affecting at least 
two extremities (including when the limitations are due to 
involvement of the perineum or the inguinal region); or
    4. Inability to maintain an upright position while standing or 
walking to the extent needed to independently initiate, sustain, and 
complete work-related activities due to chronic skin lesions (see 
8.00B2) or contractures (see 8.00B3) affecting both lower 
extremities (including when the limitations are due to involvement 
of the perineum or the inguinal region).
* * * * *

14.00 Immune System Disorders

* * * * *
    F. * * *
    5. Measurement of CD4 and either body mass index or hemoglobin 
(14.11G). To evaluate your HIV infection under 14.11G, we require 
one measurement of your absolute CD4 count or your CD4 percentage, 
and either a measurement of your body mass index (BMI) or your 
hemoglobin. These measurements must occur within the period we are 
considering in connection with your application or continuing 
disability review. If you have more than one measurement of your CD4 
(absolute count or percentage), BMI, or hemoglobin within this 
period, we will use the lowest of your CD4 (absolute count or 
percentage), BMI, or hemoglobin. The date of your lowest CD4 
(absolute count or percentage) measurement may be different from the 
date of your lowest BMI or hemoglobin measurement. We calculate your 
BMI using the formulas in the digestive disorders body system 
(5.00).
* * * * *

Part B

* * * * *

Sec.

* * * * *
    105.00 Digestive Disorders
* * * * *

100.00 Low Birth Weight and Failure to Thrive

* * * * *
    C. * * * 2. * * *
    c. BMI is the ratio of a child's weight to the square of his or 
her height. We calculate BMI using the formulas in the digestive 
disorders body system (105.00).
* * * * *

[[Page 37739]]

103.00 Respiratory Disorders

* * * * *
    K. * * *
    2. * * *
    c. BMI is the ratio of a child's weight to the square of his or 
her height. We calculate BMI using the formulas in the digestive 
disorders body system (105.00).
* * * * *

104.00 Cardiovascular System

* * * * *
    C. * * *
    3. * * *
    b. * * *
    (iii) BMI is the ratio of a child's weight to the square of his 
or her height. We calculate BMI using the formulas in the digestive 
disorders body system (105.00).
* * * * *

105.00 Digestive Disorders

    A. Which digestive disorders do we evaluate in this body system? 
We evaluate digestive disorders that result in severe dysfunction of 
the liver, pancreas, and gastrointestinal tract (the large, muscular 
tube that extends from the mouth to the anus, where the movement of 
muscles, along with the release of hormones and enzymes, allows for 
the digestion of food) in this body system. Examples of these 
disorders and the listings we use to evaluate them include chronic 
liver disease (105.05), inflammatory bowel disease (105.06), and 
intestinal failure (105.07). We also use this body system to 
evaluate gastrointestinal hemorrhaging from any cause (105.02), 
growth failure due to any digestive disorder (105.08), liver 
transplantation (105.09), need for supplemental daily enteral 
feeding via a gastrostomy, duodenostomy, or jejunostomy due to any 
cause for children who have not attained age 3 (105.10), small 
intestine transplantation (105.11), and pancreas transplantation 
(105.12). We evaluate cancers affecting the digestive system under 
the listings in 113.00.
    B. What evidence do we need to evaluate your digestive disorder?
    1. General. To establish that you have a digestive disorder, we 
need medical evidence about the existence of your digestive disorder 
and its severity. Medical evidence should include your medical 
history, physical examination findings, operative reports, and 
relevant laboratory findings.
    2. Laboratory findings. We need laboratory reports such as 
results of imaging (see 105.00B3), endoscopy, and other diagnostic 
procedures. We may also need clinical laboratory and pathology 
results.
    3. Imaging refers to medical imaging techniques, such as x-ray, 
ultrasound, magnetic resonance imaging, and computerized tomography. 
The imaging must be consistent with the prevailing state of medical 
knowledge and clinical practice as a proper technique to support the 
evaluation of the disorder.
    C. What is chronic liver disease (CLD), and how do we evaluate 
it under 105.05?
    1. General. CLD is loss of liver function with cell necrosis 
(cell death), inflammation, or scarring of the liver that persists 
for more than 6 months. Common causes of CLD in children include 
chronic infection with hepatitis B virus or hepatitis C virus, 
autoimmune hepatitis, and metabolic disease.
    a. We will evaluate your signs of CLD, such as jaundice, changes 
in size of the liver and spleen, ascites, peripheral edema, and 
altered mental status. We will also evaluate your symptoms of CLD, 
such as pruritus (itching), fatigue, nausea, loss of appetite, and 
sleep disturbances when we assess the severity of your impairment(s) 
and how it affects your ability to function. In the absence of 
evidence of a chronic liver impairment, episodes of acute liver 
disease do not meet the requirements of 105.05.
    b. Laboratory findings of your CLD may include decreased serum 
albumin, increased International Normalized Ratio (INR), arterial 
deoxygenation (hypoxemia), increased serum creatinine, oliguria 
(reduced urine output), or sodium retention. Another laboratory 
finding that may be included in the evidence is a liver biopsy. If 
you have had a liver biopsy, we will make every reasonable effort to 
obtain the results; however, we will not purchase a liver biopsy.
    2. Manifestations of CLD.
    a. Gastrointestinal hemorrhaging (105.05A), as a consequence of 
cirrhosis and high pressure in the liver's portal venous system, may 
occur from varices (dilated veins in the esophagus or the stomach) 
or from portal hypertensive gastropathy (abnormal mucosal changes in 
the stomach). When gastrointestinal hemorrhaging is due to a cause 
other than CLD, we evaluate it under 105.02. The phrase ``consider 
under a disability for 1 year'' in 105.02 and 105.05A does not refer 
to the date on which your disability began, only to the date on 
which we must reevaluate whether your impairment(s) continues to 
meet a listing or is otherwise disabling. We determine the onset of 
your disability based on the facts of your case.
    b. Ascites or hydrothorax (105.05B) is a pathologic accumulation 
of fluid in the peritoneal cavity (ascites) or pleural space 
(hydrothorax). Ascites or hydrothorax may be diagnosed by removing 
some of the fluid with needle aspiration (paracentesis or 
thoracentesis), physical examination, or imaging. The most common 
causes of ascites are portal hypertension and low serum albumin 
resulting from CLD. We evaluate other causes of ascites and 
hydrothorax that are unrelated to CLD, such as congestive heart 
failure and cancer, under the listings in the affected body systems.
    c. Spontaneous bacterial peritonitis (SBP) (105.05C) is an acute 
bacterial infection of peritoneal fluid and is most commonly 
associated with CLD. SBP is diagnosed by laboratory analysis of 
peritoneal fluid (obtained by paracentesis) that contains a 
neutrophil count (also called absolute neutrophil count) of at least 
250 cells/mm\3\. 105.05C is satisfied with one evaluation 
documenting peritoneal infection. We evaluate other causes of 
peritonitis that are unrelated to CLD, such as tuberculosis, 
malignancy, and perforated bowel, under the listings in the affected 
body systems.
    d. Hepatorenal syndrome (105.05D) is renal failure associated 
with CLD in the absence of underlying kidney pathology. Findings 
associated with hepatorenal syndrome include elevation of serum 
creatinine, sodium retention with low urinary sodium excretion, and 
oliguria. We evaluate renal dysfunction with known underlying kidney 
pathology, such as glomerulonephritis, tubular necrosis, and renal 
infections, under the listings in 106.00.
    e. Hepatopulmonary syndrome (105.05E) is arterial deoxygenation 
due to intrapulmonary vascular dilation and arteriovenous shunting 
associated with CLD. Clinical findings of hepatopulmonary syndrome 
include platypnea (shortness of breath relieved when lying down) and 
orthodeoxia (low arterial blood oxygen while in the upright 
position), when presenting in the context of CLD. We evaluate 
pulmonary dysfunction with known underlying respiratory pathology, 
such as asthma, pneumonia, and pulmonary infections, under the 
listings in 103.00.
    (i) Under 105.05E1, we require a resting arterial blood gas 
(ABG) measurement obtained while you are breathing room air; that 
is, without oxygen supplementation. The ABG report must include the 
PaO2 value, your name, the date of the test, 
and either the altitude or both the city and State of the test site.
    (ii) We will not purchase the specialized imaging techniques 
described in 105.05E2; however, if you have had the test(s) at a 
time relevant to your claim, we will make every reasonable effort to 
obtain the report.
    f. Hepatic encephalopathy (105.05F), also known as portosystemic 
encephalopathy, is a recurrent or chronic neuropsychiatric disorder 
associated with CLD.
    (i) Under 105.05F2, we require documentation of a mental 
impairment associated with hepatic encephalopathy. A mental 
impairment can include abnormal behavior, changes in mental status, 
or an altered state of consciousness. Reports of abnormal behavior 
may show that you are experiencing delusions, paranoia, or 
hallucinations. Reports of changes in mental status may show change 
in sleep patterns, personality or mood changes, poor concentration, 
or poor judgment or cognitive dysfunction (for example, impaired 
memory, poor problem-solving ability, or attention deficits). 
Reports of altered state of consciousness may show that you are 
experiencing confusion, delirium, or stupor.
    (ii) Signs and laboratory findings that document the severity of 
hepatic encephalopathy when not attributable to other causes may 
include a ``flapping tremor'' (asterixis), characteristic 
abnormalities found on an electroencephalogram (EEG), or abnormal 
serum albumin or coagulation values. We will not purchase an EEG; 
however, if you have had this test at a time relevant to your claim, 
we will make every reasonable effort to obtain the report for the 
purpose of establishing whether your impairment meets the criteria 
of 105.05F.
    (iii) We will not evaluate acute encephalopathy under 105.05F if 
it results from conditions other than CLD. For example, we will 
evaluate acute encephalopathy caused by vascular events under the 
listings in 111.00 and acute encephalopathy caused by cancer under 
the listings in 113.00.

[[Page 37740]]

    3. SSA Chronic Liver Disease (SSA CLD) and SSA Chronic Liver 
Disease-Pediatric (SSA CLD-P) scores (105.05G). Listing 105.05G1 
requires two SSA CLD scores, each requiring three or four laboratory 
values. Listing 105.05G2 requires one SSA CLD-P score, which 
requires four parameters (three laboratory values and growth 
failure). The ``date of the SSA CLD score'' is the date of the 
earliest of the three or four laboratory values used for its 
calculation. The ``date of the SSA CLD-P score'' is the date of the 
earliest of the three laboratory values used for its calculation. 
For 105.05G1, the date of the second SSA CLD score must be at least 
60 days after the date of the first SSA CLD score and both scores 
must be within the required 12-month period. If you have the two SSA 
CLD scores required by 105.05G1, we will find that your impairment 
meets the criteria of the listing from at least the date of the 
first SSA CLD score.
    a. SSA CLD score.
    (i) If you are age 12 or older, we will calculate the SSA CLD 
score using a formula that includes up to four laboratory values: 
Serum creatinine (mg/dL), total bilirubin (mg/dL), INR, and under 
certain conditions, serum sodium (mmol/L). The SSA CLD score 
calculation contains at least one, and sometimes two, parts, as 
described in (a) and (b).
    (a) The initial calculation is:

SSA CLDi =
+ 3.78 x [loge (serum total bilirubin mg/dL)]
+ 11.2 x [loge (INR)]
+ 6.43
rounded to the nearest whole integer.
    (b) If the value from the initial calculation is 11 or below, 
the SSA CLD score will be the SSA CLDi value. If the 
value from the initial calculation is greater than 11, the SSA CLD 
score will be re-calculated as:

SSA CLD =
SSA CLDi
+ 1.32 x (137 - serum sodium mmol/L)
- [0.033 x SSA CLDi x (137 - serum sodium mmol/L)]
    (c) We round the results of your SSA CLD score calculation to 
the nearest whole integer to arrive at your SSA CLD score.
    (ii) For any SSA CLD score calculation, all of the required 
laboratory values (serum creatinine, serum total bilirubin, INR, and 
serum sodium) must have been obtained within a continuous 30-day 
period.
    (a) We round values for serum creatinine (mg/dL), serum total 
bilirubin (mg/dL), or INR less than 1.0 up to 1.0 to calculate your 
SSA CLD score.
    (b) We round values for serum creatinine (mg/dL) greater than 
4.0 down to 4.0 to calculate your SSA CLD score.
    (c) If there are multiple laboratory values within the 30-day 
interval for serum creatinine (mg/dL), serum total bilirubin (mg/
dL), or INR, we use the highest value to calculate your SSA CLD 
score. We will not use any INR values derived from testing done 
while you are on anticoagulant treatment in our SSA CLD calculation.
    (d) If there are multiple laboratory values within the 30-day 
interval for serum sodium (mmol/L), we use the lowest value to 
calculate your SSA CLD score.
    (e) If you are in renal failure or on renal dialysis within a 
week of any serum creatinine test in the period used for the SSA CLD 
calculation, we will use a serum creatinine value of 4.0, which is 
the maximum serum creatinine level allowed in the calculation, to 
calculate your SSA CLD score.
    (f) If your serum sodium is less than 125 mmol/L, we will set 
your serum sodium to 125 mmol/L for purposes of calculation of the 
SSA CLD score. If your serum sodium is higher than 137 mmol/L, we 
will set your serum sodium to 137 mmol/L for purposes of calculation 
of the SSA CLD score.
    (iii) When we indicate ``loge'' (also abbreviated 
``ln'') in the formula for the SSA CLD score calculation, we mean 
the ``base e logarithm'' or ``natural logarithm'' of the numerical 
laboratory value, not the ``base 10 logarithm'' or ``common 
logarithm'' (log) of the laboratory value, and not the actual 
laboratory value. For example, if a person has laboratory values of 
serum creatinine 1.4 mg/dL, serum total bilirubin 1.3 mg/dL, INR 
1.32, and serum sodium 119 mmol/L, we compute the SSA CLD score as 
follows:

SSA CLDi =
9.57 x [loge(serum creatinine 1.4 mg/dL) = 0.336]
+ 3.78 x [loge(serum total bilirubin 1.3 mg/dL) = 0.262]
+ 11.2 x [loge(INR 1.32) = .278]
+ 6.43
= 3.22 + 0.99 + 3.11 + 6.43
= 13.75, which we round to an SSA CLDi score of 14.

    Because the SSA CLDi score is over 11, we then move 
to the second step of calculating the SSA CLD:

SSA CLD =
14
+ 1.32 x (137-serum sodium 125 mmol/L)
-[0.033 x SSA CLDi 14 x (137-serum sodium 125 mmol/L)
= 14 + 15.84-5.54
= 24.3, which we round to an SSA CLD score of 24.

    b. SSA CLD-P score
    (i) We calculate the SSA CLD-P score using a formula that 
includes four parameters: Serum total bilirubin (mg/dL), INR, serum 
albumin (g/dL), and whether you have growth failure. The formula for 
the SSA CLD-P score calculation is:

4.80 x [loge(serum total bilirubin mg/dL)]
+ 18.57 x [loge(INR)]
-6.87 x [loge(serum albumin g/dL)]
+ 6.67 if you have growth failure (<-2 standard deviations for 
weight or height)

    (ii) When we indicate ``loge'' in the formula for the 
SSA CLD-P score calculation, we mean the ``base e logarithm'' or 
``natural logarithm'' (loge) of a numerical laboratory 
value, not the ``base 10 logarithm'' or ``common logarithm'' (log) 
of the laboratory value, and not the actual laboratory value. For 
example, if a female child is 4.0 years old, has growth failure, and 
has laboratory values of serum total bilirubin 2.2 mg/dL, INR 1.0, 
and serum albumin 3.5 g/dL, we compute the SSA CLD-P score as 
follows:

4.80 x [loge(serum total bilirubin 2.2 mg/dL) = 0.788]
+ 18.57 x [loge(INR 1.0) = 0]
-6.87 x [loge(serum albumin 3.5 g/dL) = 1.253]
+ 6.67
= 3.78 + 0-8.61 + 6.67
= 1.84, which we round to an SSA CLD-P score of 2.

    (iii) For an SSA CLD-P score calculation, all of the required 
laboratory values (serum total bilirubin, INR, and serum albumin) 
must have been obtained within a continuous 30-day period. We round 
any of the required laboratory values less than 1.0 up to 1.0 to 
calculate your SSA CLD-P score. If there are multiple laboratory 
values within the 30-day interval for any given laboratory test, we 
use the highest serum total bilirubin and INR values and the lowest 
serum albumin value to calculate the SSA CLD-P score. We will not 
use any INR values derived from testing done while you are on 
anticoagulant treatment in our SSA CLD-P calculation. We will not 
purchase INR values for children who have not attained age 12. If 
there is no INR value for a child under 12 within the applicable 
period, we will use an INR value of 1.1 to calculate the SSA CLD-P 
score. We round the results of your SSA CLD-P score calculation to 
the nearest whole integer to arrive at your SSA CLD-P score.
    (iv) The weight and length/height measurements used for the 
calculation must be obtained within the same 30-day period as the 
laboratory values.
    4. Extrahepatic biliary atresia (105.05H) presents itself in the 
first 2 months of life with persistent jaundice. To satisfy 105.05H, 
the diagnosis of extrahepatic biliary atresia must be confirmed by 
liver biopsy or intraoperative cholangiogram that shows obliteration 
of the extrahepatic biliary tree. Biliary atresia is usually treated 
surgically by portoenterostomy (for example, Kasai procedure). If 
this surgery is not performed in the first months of life or is not 
completely successful, liver transplantation is indicated. If you 
have received a liver transplant, we will evaluate your impairment 
under 105.09. The phrase ``consider under a disability for 1 year'' 
in 105.05H does not refer to the date on which your disability 
began, only to the date on which we must reevaluate whether your 
impairment(s) continues to meet a listing or is otherwise disabling. 
We determine the onset of your disability based on the facts of your 
case.
    D. What is inflammatory bowel disease (IBD), and how do we 
evaluate it under 105.06?
    1. IBD is a group of inflammatory conditions of the small 
intestine and colon. The most common IBD disorders are Crohn's 
disease and ulcerative colitis. Remissions and exacerbations of 
variable duration are a hallmark of IBD.
    2. We evaluate your signs and symptoms of IBD, such as diarrhea, 
fecal incontinence, rectal bleeding, abdominal pain, fatigue, fever, 
nausea, vomiting, arthralgia, abdominal tenderness, palpable 
abdominal mass (usually inflamed loops of bowel), and perianal 
disease (for example, fissure, fistulas, abscesses, or anal canal 
stenosis), when we assess the severity of your impairment(s). You 
may require supplemental daily nutrition due to IBD. There are two 
forms of supplemental daily nutrition we consider under 105.06B5: 
enteral nutrition (delivered directly to a part

[[Page 37741]]

of your digestive system) via a gastrostomy, duodenostomy, or 
jejunostomy, and parenteral nutrition delivered via a central venous 
catheter. Enteral tube feedings delivered via nasal or oral tubes do 
not satisfy the requirement in 105.06B5.
    3. Surgical diversion of the intestinal tract, including 
ileostomy and colostomy, does not very seriously interfere with age-
appropriate functioning if you are able to maintain adequate 
nutrition and function of the stoma. However, if you are not able to 
maintain adequate nutrition, we will evaluate your impairment under 
105.08.
    4. IBD may be associated with significant extraintestinal 
manifestations in a variety of body systems. These include, but are 
not limited to, involvement of the eye (for example, uveitis, 
episcleritis, or iritis); hepatobiliary disease (for example, 
gallstones or primary sclerosing cholangitis); urologic disease (for 
example, kidney stones or obstructive hydronephrosis); skin 
involvement (for example, erythema nodosum or pyoderma gangrenosum); 
or non-destructive inflammatory arthritis. You may also have 
associated thromboembolic disorders or vascular disease. These 
manifestations may not correlate with the severity of your IBD. If 
your impairment does not meet any of the criteria of 105.06, we will 
consider the effects of your extraintestinal manifestations in 
determining whether you have an impairment(s) that meets or 
medically equals another listing, and when we determine whether your 
impairment(s) functionally equals the listings.
    5. Examples of complications of IBD that may result in 
hospitalization include abscesses, intestinal perforation, toxic 
megacolon, infectious colitis, pyoderma gangrenosum, ureteral 
obstruction, primary sclerosing cholangitis, and hypercoagulable 
state (which may lead to thromboses or embolism).
    E. What is intestinal failure, and how do we evaluate it under 
105.07?
    1. Intestinal failure is a condition resulting in gut function 
below the minimum necessary for the absorption of macronutrients or 
water and electrolytes, resulting in a requirement for intravenous 
supplementation (i.e., parenteral nutrition) to maintain health. 
Examples of conditions that may result in intestinal failure include 
short bowel syndrome, extensive small bowel mucosal disease, and 
chronic motility disorders.
    2. Short bowel syndrome is a malabsorption disorder that occurs 
when ischemic vascular insults (caused, for example, by volvulus or 
necrotizing enterocolitis), trauma, or IBD complications require(s) 
surgical resection of any amount of the small intestine, resulting 
in chronic malnutrition.
    3. Extensive small bowel mucosal disease means that the mucosal 
surface of the small bowel does not efficiently absorb nutrients or 
loses nutrients. Common causes of small bowel mucosal disease 
include microvillous inclusion disease and tufting enteropathy.
    4. Chronic motility disorder refers to a chronic disorder of the 
propulsion of gut content without fixed obstructions, causing 
intolerance to oral nutrition and inadequate nutritional intake. 
This type of disorder may also be known as a chronic intestinal 
pseudo-obstruction (CIPO), because the gut dysfunction mimics that 
of an obstructed intestine, but without evidence of an actual 
obstruction. Primary CIPO may have an unknown underlying cause. 
Chronic motility disorders may also result from congenital, 
neuromuscular, or autoimmune conditions, such as gastroschisis, 
omphalocele, long segment Hirschprung's disease, Crohn's disease, 
and mitochondrial disorders.
    5. For short bowel syndrome, we require a copy of the operative 
report that includes details of the surgical findings, or 
postoperative imaging indicating a resection of the small intestine. 
If we cannot get one of these reports, we need other medical reports 
that include details of the surgical findings. For other chronic 
motility disorders or extensive small bowel mucosal disease, we need 
medical reports that include details of your intestinal dysfunction. 
For any impairment evaluated under 105.07, we also need medical 
documentation that you are dependent on daily parenteral nutrition 
to provide most of your nutritional requirements.
    F. How do we evaluate growth failure due to any digestive 
disorder under 105.08?
    1. To evaluate growth failure due to any digestive disorder, we 
require documentation of the laboratory findings of chronic 
nutritional deficiency described in 105.08A and the growth 
measurements in 105.08B within the same consecutive 12-month period. 
The dates of laboratory findings may be different from the dates of 
growth measurements. Impairments other than digestive disorders that 
cause weight loss should be evaluated under the appropriate body 
system. For instance, weight loss as a result of chronic kidney 
disease should be evaluated under our rules for genitourinary 
disorders (see 106.00), and weight loss as the result of an eating 
disorder should be evaluated under our rules for mental disorders 
(see 112.00). However, if you develop a digestive disorder as the 
result of your other impairment, we will evaluate the acquired 
digestive disorder under our rules for digestive disorders.
    2. Under 105.08B, we evaluate a child's growth failure by using 
the appropriate table for age and gender.
    a. For children from birth to attainment of age 2, we use the 
weight-for-length table (see Table I or Table II).
    b. For children age 2 to attainment of age 18, we use the body 
mass index (BMI)-for-age table (see Table III or Table IV).
    c. BMI is the ratio of your weight to the square of your height. 
We calculate BMI using one of the following formulas:

English Formula
BMI = [Weight in Pounds/(Height in Inches x Height in Inches)] x 703
Metric Formulas
BMI = Weight in Kilograms/(Height in Meters x Height in Meters)
BMI = [Weight in Kilograms/(Height in Centimeters x Height in 
Centimeters)] x 10,000

    G. How do we evaluate digestive organ transplantation? If you 
receive a liver (105.09), small intestine (105.11), or pancreas 
(105.12) transplant, we will consider you disabled under the listing 
for 1 year from the date of the transplant. After that, we evaluate 
your residual impairment(s) by considering the adequacy of your 
post-transplant function, the frequency and severity of any 
rejection episodes you have, complications in other body systems, 
and adverse treatment effects. People who receive digestive organ 
transplants generally have impairments that meet our definition of 
disability before they undergo transplantation. The phrase 
``consider under a disability for 1 year'' in 105.09, 105.11, and 
105.12 does not refer to the date on which your disability began, 
only to the date on which we must reevaluate whether your 
impairment(s) continues to meet a listing or is otherwise disabling. 
We determine the onset of your disability based on the facts of your 
case.
    H. How do we evaluate the need for supplemental daily enteral 
feeding via a gastrostomy, duodenostomy, or jejunostomy? We evaluate 
the need for supplemental daily enteral feeding via a gastrostomy, 
duodenostomy, or jejunostomy in children who have not attained age 3 
under 105.10 regardless of the medical reason for the stoma. Enteral 
tube feedings delivered via nasal or oral tubes do not satisfy the 
requirement in 105.10. After a child attains age 3, we evaluate 
growth failure due to any digestive disorder under 105.08, IBD 
requiring supplemental daily enteral or parenteral nutrition under 
105.06, or other medical or developmental disorders under another 
digestive disorders listing or under a listing in an affected body 
system(s).
    I. How do we evaluate esophageal stricture or stenosis? 
Esophageal stricture or stenosis (narrowing) from congenital atresia 
(absence or abnormal closure of a tubular body organ) or destructive 
esophagitis may result in malnutrition or the need for gastrostomy 
placement, which we evaluate under 105.08 or 105.10. Esophageal 
stricture or stenosis may also result in complications such as 
pneumonias due to frequent aspiration, or difficulty in maintaining 
nutritional status short of listing level severity. While these 
individual complications usually do not meet the listing criteria, a 
combination of your impairments may medically equal a listing or 
functionally equal the listings.
    J. How do we evaluate your digestive disorder if there is no 
record of ongoing treatment? If there is no record of ongoing 
treatment despite the existence of a severe impairment(s), we will 
assess the severity and duration of your digestive disorder based on 
the current medical and other evidence in your case record. If there 
is no record of ongoing treatment, you may not be able to show an 
impairment that meets a digestive disorders listing, but your 
impairment may medically equal a listing, or be disabling based on 
our rules for functional equivalence.
    K. How do we evaluate your digestive disorder if there is 
evidence establishing a substance use disorder? If we find that you 
are disabled and there is medical evidence in your case record 
establishing that you have a substance use disorder, we will 
determine whether your substance use disorder is a contributing 
factor material to the

[[Page 37742]]

determination of disability. See Sec.  416.935 of this chapter. 
Digestive disorders resulting from drug or alcohol use are often 
chronic in nature and will not necessarily improve with cessation in 
drug or alcohol use.
    L. How do we evaluate digestive disorders that do not meet one 
of these listings?
    1. These listings are only examples of common digestive 
disorders that we consider severe enough to result in marked and 
severe functional limitations. If your impairment(s) does not meet 
the criteria of any of these listings, we must also consider whether 
you have an impairment(s) that satisfies the criteria of a listing 
in another body system.
    2. If you have a severe medically determinable impairment(s) 
that does not meet a listing, we will determine whether your 
impairment(s) medically equals a listing. See Sec.  416.926 of this 
chapter. Digestive disorders may be associated with disorders in 
other body systems, and we consider the combined effects of multiple 
impairments when we determine whether they medically equal a 
listing. If your impairment(s) does not meet or medically equal a 
listing, we will also consider whether it functionally equals the 
listings. See Sec.  416.926a of this chapter. We use the rules in 
Sec.  416.994a of this chapter when we decide whether you continue 
to be disabled.
    105.01 Category of Impairments, Digestive Disorders
    105.02 Gastrointestinal hemorrhaging from any cause, requiring 
three blood transfusions of at least 10 cc of blood/kg of body 
weight per transfusion, within a consecutive 12-month period and at 
least 30 days apart. Consider under a disability for 1 year 
following the last documented transfusion; after that, evaluate the 
residual impairment(s).
    105.03-105.04 [Reserved]
    105.05 Chronic liver disease (CLD) (see 105.00C) with A, B, C, 
D, E, F, G, or H:
    A. Hemorrhaging from esophageal, gastric, or ectopic varices, or 
from portal hypertensive gastropathy (see 105.00C2a), documented by 
imaging (see 105.00B3); resulting in 1 and 2:
    1. Hemodynamic instability indicated by signs such as pallor 
(pale skin), diaphoresis (profuse perspiration), rapid pulse, low 
blood pressure, postural hypotension (pronounced fall in blood 
pressure when arising to an upright position from lying down), or 
syncope (fainting); and 2. Requiring hospitalization for transfusion 
of at least 10 cc of blood/kg of body weight. Consider under a 
disability for 1 year following the documented transfusion; after 
that, evaluate the residual impairment(s).

OR

    B. Ascites or hydrothorax not attributable to other causes (see 
105.00C2b), present on 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:
    1. Paracentesis; or
    2. Thoracentesis; or
    3. Imaging or physical examination with a or b:
    a. Serum albumin of 3.0 g/dL or less; or
    b. INR of at least 1.5.

OR

    C. Spontaneous bacterial peritonitis (see 105.00C2c) documented 
by peritoneal fluid containing a neutrophil count of at least 250 
cells/mm\3\.

OR

    D. Hepatorenal syndrome (see 105.00C2d) documented by 1, 2, or 
3:
    1. Serum creatinine elevation of at least 2 mg/dL; or
    2. Oliguria with 24-hour urine output less than 1 mL/kg/hr; or
    3. Sodium retention with urine sodium less than 10 mEq per 
liter.

OR

    E. Hepatopulmonary syndrome (see 105.00C2e) documented by 1 or 
2:
    1. Arterial PaO2 measured by an ABG test, 
while at rest, breathing room air, less than or equal to:
    a. 60 mm Hg, at test sites less than 3,000 feet above sea level; 
or
    b. 55 mm Hg, at test sites from 3,000 through 6,000 feet above 
sea level; or
    c. 50 mm Hg, at test sites over 6,000 feet above sea level; or
    2. Intrapulmonary arteriovenous shunting as shown on contrast-
enhanced echocardiography or macroaggregated albumin lung perfusion 
scan.

OR

    F. Hepatic encephalopathy (see 105.00C2f) with documentation of 
abnormal behavior, cognitive dysfunction, changes in mental status, 
or altered state of consciousness (for example, confusion, delirium, 
stupor, or coma), present on two evaluations within a consecutive 
12-month period and at least 60 days apart and either 1 or 2:
    1. History of transjugular intrahepatic portosystemic shunt 
(TIPS) or other surgical portosystemic shunt; or
    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:
    a. Asterixis or other fluctuating physical neurological 
abnormalities; or
    b. EEG demonstrating triphasic slow wave activity; or
    c. Serum albumin of 3.0 g/dL or less; or
    d. INR of 1.5 or greater.

OR

    G. SSA CLD or SSA CLD-P scores (see 105.00C3):
    1. For children age 12 or older, two SSA CLD scores of at least 
20 within a consecutive 12-month period and at least 60 days apart. 
Consider under a disability from at least the date of the first 
score; or
    2. For children who have not attained age 12, one SSA CLD-P 
score of at least 11.

OR

    H. Extrahepatic biliary atresia as diagnosed on liver biopsy or 
intraoperative cholangiogram (see 105.00C4). Consider under a 
disability for 1 year following diagnosis; after that, evaluate the 
residual impairment(s).
    105.06 Inflammatory bowel disease (IBD) (see 105.00D) documented 
by endoscopy, biopsy, imaging, or operative findings and 
demonstrated by A or B:
    A. Obstruction of stenotic areas (not adhesions) in the small 
intestine or colon with proximal dilatation, confirmed by imaging or 
in surgery, requiring two hospitalizations for 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:
    1. Anemia with hemoglobin less than 10.0 g/dL, present on at 
least two evaluations at least 60 days apart; or
    2. Serum albumin of 3.0 g/dL or less, present on at least two 
evaluations at least 60 days apart; or
    3. Clinically documented tender abdominal mass palpable on 
physical examination with abdominal pain or cramping; or
    4. Perianal disease with a draining abscess or fistula; or
    5. Need for supplemental daily enteral nutrition via a 
gastrostomy, duodenostomy, or jejunostomy, or daily parenteral 
nutrition via a central venous catheter (see 105.10 for children who 
have not attained age 3).
    105.07 Intestinal failure (see 105.00E) due to short bowel 
syndrome, chronic motility disorders, or extensive small bowel 
mucosal disease, resulting in dependence on daily parenteral 
nutrition via a central venous catheter for at least 12 months.
    105.08 Growth failure due to any digestive disorder (see 
105.00F), documented by A and B:
    A. Chronic nutritional deficiency present on two evaluations 
within a consecutive 12-month period and at least 60 days apart 
documented by 1 or 2:
    1. Anemia with hemoglobin less than 10.0 g/dL; or
    2. Serum albumin of 3.0 g/dL or less.

AND

    B. Growth failure as required in 1 or 2:
    1. For children from birth to attainment of age 2, three weight-
for-length measurements that are:
    a. Within a consecutive 12-month period; and
    b. At least 60 days apart; and
    c. Less than the third percentile values in Table I or Table II; 
or

[[Page 37743]]



                                   Table I--Males Birth to Attainment of Age 2
                                 [Third percentile values for weight-for-length]
----------------------------------------------------------------------------------------------------------------
                         Weight                             Weight
Length (centimeters)  (kilograms)  Length (centimeters)  (kilograms)  Length (centimeters)   Weight (kilograms)
----------------------------------------------------------------------------------------------------------------
               45.0   1.597                       64.5   6.132                       84.5                10.301
               45.5   1.703                       65.5   6.359                       85.5                10.499
               46.5   1.919                       66.5   6.584                       86.5                10.696
               47.5   2.139                       67.5   6.807                       87.5                10.895
               48.5   2.364                       68.5   7.027                       88.5                11.095
               49.5   2.592                       69.5   7.245                       89.5                11.296
               50.5   2.824                       70.5   7.461                       90.5                11.498
               51.5   3.058                       71.5   7.674                       91.5                11.703
               52.5   3.294                       72.5   7.885                       92.5                11.910
               53.5   3.532                       73.5   8.094                       93.5                12.119
               54.5   3.771                       74.5   8.301                       94.5                12.331
               55.5   4.010                       75.5   8.507                       95.5                12.546
               56.5   4.250                       76.5   8.710                       96.5                12.764
               57.5   4.489                       77.5   8.913                       97.5                12.987
               58.5   4.728                       78.5   9.113                       98.5                13.213
               59.5   4.966                       79.5   9.313                       99.5                13.443
               60.5   5.203                       80.5   9.512                      100.5                13.678
               61.5   5.438                       81.5   9.710                      101.5                13.918
               62.5   5.671                       82.5   9.907                      102.5                14.163
               63.5   5.903                       83.5   10.104                     103.5                14.413
----------------------------------------------------------------------------------------------------------------


                                 Table II--Females Birth to Attainment of Age 2
                                 [Third percentile values for weight-for-length]
----------------------------------------------------------------------------------------------------------------
                         Weight                             Weight
Length (centimeters)  (kilograms)  Length (centimeters)  (kilograms)  Length (centimeters)   Weight (kilograms)
----------------------------------------------------------------------------------------------------------------
               45.0   1.613                       64.5   5.985                       84.5                10.071
               45.5   1.724                       65.5   6.200                       85.5                10.270
               46.5   1.946                       66.5   6.413                       86.5                10.469
               47.5   2.171                       67.5   6.625                       87.5                10.670
               48.5   2.397                       68.5   6.836                       88.5                10.871
               49.5   2.624                       69.5   7.046                       89.5                11.074
               50.5   2.852                       70.5   7.254                       90.5                11.278
               51.5   3.081                       71.5   7.461                       91.5                11.484
               52.5   3.310                       72.5   7.667                       92.5                11.691
               53.5   3.538                       73.5   7.871                       93.5                11.901
               54.5   3.767                       74.5   8.075                       94.5                12.112
               55.5   3.994                       75.5   8.277                       95.5                12.326
               56.5   4.220                       76.5   8.479                       96.5                12.541
               57.5   4.445                       77.5   8.679                       97.5                12.760
               58.5   4.669                       78.5   8.879                       98.5                12.981
               59.5   4.892                       79.5   9.078                       99.5                13.205
               60.5   5.113                       80.5   9.277                      100.5                13.431
               61.5   5.333                       81.5   9.476                      101.5                13.661
               62.5   5.552                       82.5   9.674                      102.5                13.895
               63.5   5.769                       83.5   9.872                      103.5                14.132
----------------------------------------------------------------------------------------------------------------

    2. For children age 2 to attainment of age 18, three BMI-for-age 
measurements that are:
    a. Within a consecutive 12-month period; and
    b. At least 60 days apart; and
    c. Less than the third percentile value in Table III or Table 
IV.

                                 Table III--Males Age 2 to Attainment of Age 18
                                    [Third percentile values for BMI-for-age]
----------------------------------------------------------------------------------------------------------------
  Age (yrs. and mos.)      BMI     Age (yrs. and mos.)      BMI     Age (yrs. and mos.)             BMI
----------------------------------------------------------------------------------------------------------------
           2.0 to 2.1    14.5            10.11 to 11.2    14.3           14.9 to 14.10                    16.1
           2.2 to 2.4    14.4             11.3 to 11.5    14.4           14.11 to 15.0                    16.2
           2.5 to 2.7    14.3             11.6 to 11.8    14.5            15.1 to 15.3                    16.3
          2.8 to 2.11    14.2            11.9 to 11.11    14.6            15.4 to 15.5                    16.4
           3.0 to 3.2    14.1             12.0 to 12.1    14.7            15.6 to 15.7                    16.5
           3.3 to 3.6    14.0             12.2 to 12.4    14.8            15.8 to 15.9                    16.6
          3.7 to 3.11    13.9             12.5 to 12.7    14.9          15.10 to 15.11                    16.7
           4.0 to 4.5    13.8             12.8 to 12.9    15.0            16.0 to 16.1                    16.8

[[Page 37744]]

 
           4.6 to 5.0    13.7            12.10 to 13.0    15.1            16.2 to 16.3                    16.9
           5.1 to 6.0    13.6             13.1 to 13.2    15.2            16.4 to 16.5                    17.0
           6.1 to 7.6    13.5             13.3 to 13.4    15.3            16.6 to 16.8                    17.1
           7.7 to 8.6    13.6             13.5 to 13.7    15.4           16.9 to 16.10                    17.2
           8.7 to 9.1    13.7             13.8 to 13.9    15.5           16.11 to 17.0                    17.3
           9.2 to 9.6    13.8           13.10 to 13.11    15.6            17.1 to 17.2                    17.4
          9.7 to 9.11    13.9             14.0 to 14.1    15.7            17.3 to 17.5                    17.5
         10.0 to 10.3    14.0             14.2 to 14.4    15.8            17.6 to 17.7                    17.6
         10.4 to 10.7    14.1             14.5 to 14.6    15.9            17.8 to 17.9                    17.7
        10.8 to 10.10    14.2             14.7 to 14.8    16.0          17.10 to 17.11                    17.8
----------------------------------------------------------------------------------------------------------------


                                 Table IV--Females Age 2 to Attainment of Age 18
                                    [Third percentile values for BMI-for-age]
----------------------------------------------------------------------------------------------------------------
  Age (yrs. and mos.)      BMI     Age (yrs. and mos.)      BMI     Age (yrs. and mos.)             BMI
----------------------------------------------------------------------------------------------------------------
           2.0 to 2.2    14.1            10.8 to 10.10    14.0            14.3 to 14.5                    15.6
           2.3 to 2.6    14.0            10.11 to 11.2    14.1            14.6 to 14.7                    15.7
          2.7 to 2.10    13.9             11.3 to 11.5    14.2            14.8 to 14.9                    15.8
          2.11 to 3.2    13.8             11.6 to 11.7    14.3           14.10 to 15.0                    15.9
           3.3 to 3.6    13.7            11.8 to 11.10    14.4            15.1 to 15.2                    16.0
          3.7 to 3.11    13.6            11.11 to 12.1    14.5            15.3 to 15.5                    16.1
           4.0 to 4.4    13.5             12.2 to 12.4    14.6            15.6 to 15.7                    16.2
          4.5 to 4.11    13.4             12.5 to 12.6    14.7           15.8 to 15.10                    16.3
           5.0 to 5.9    13.3             12.7 to 12.9    14.8           15.11 to 16.0                    16.4
          5.10 to 7.6    13.2           12.10 to 12.11    14.9            16.1 to 16.3                    16.5
           7.7 to 8.4    13.3             13.0 to 13.2    15.0            16.4 to 16.6                    16.6
          8.5 to 8.10    13.4             13.3 to 13.4    15.1            16.7 to 16.9                    16.7
          8.11 to 9.3    13.5             13.5 to 13.7    15.2           16.10 to 17.0                    16.8
           9.4 to 9.8    13.6             13.8 to 13.9    15.3            17.1 to 17.3                    16.9
          9.9 to 10.0    13.7            13.10 to 14.0    15.4            17.4 to 17.7                    17.0
         10.1 to 10.4    13.8             14.1 to 14.2    15.5           17.8 to 17.11                    17.1
         10.5 to 10.7    13.9    .......................  ......  ......................  ......................
----------------------------------------------------------------------------------------------------------------

    105.09 Liver transplantation (see 105.00G). Consider under a 
disability for 1 year from the date of the transplant; after that, 
evaluate the residual impairment(s).
    105.10 Need for supplemental daily enteral feeding via a 
gastrostomy, duodenostomy, or jejunostomy (see 105.00H) due to any 
cause, for children who have not attained age 3; after that, 
evaluate the residual impairment(s).
    105.11 Small intestine transplantation (see 105.00G). Consider 
under a disability for 1 year from the date of the transplant; after 
that, evaluate the residual impairment(s).
    105.12 Pancreas transplantation (see 105.00G). Consider under a 
disability for 1 year from the date of the transplant; after that, 
evaluate the residual impairment(s).

106.00 Genitourinary Disorders

    C. * * *
    5. * * *
    b. * * *
    (iii) BMI is the ratio of a child's weight to the square of his 
or her height. We calculate BMI using the formulas in the digestive 
disorders body system (105.00).
* * * * *

108.00 Skin Disorders

    A. Which skin disorders do we evaluate under these listings? We 
use these listings to evaluate skin disorders that result from 
hereditary, congenital, or acquired pathological processes. We 
evaluate genetic photosensitivity disorders (108.07), burns 
(108.08), and chronic conditions of the skin or mucous membranes 
such as ichthyosis, bullous disease, dermatitis, psoriasis, and 
hidradenitis suppurativa (108.09) under these listings.
    B. What are our definitions for the following terms used in this 
body system?
    1. Assistive device(s): An assistive device, for the purposes of 
these listings, is any device used to improve stability, dexterity, 
or mobility. An assistive device can be hand-held, such as a 
cane(s), a crutch(es), or a walker; used in a seated position, such 
as a wheelchair, rollator, or power operated vehicle; or worn, such 
as a prosthesis or an orthosis.
    2. Chronic skin lesions: Chronic skin lesions can have recurrent 
exacerbations (see 108.00B7). They can occur despite prescribed 
medical treatment. These chronic skin lesions can develop on any 
part of your body, including upper extremities, lower extremities, 
palms of your hands, soles of your feet, the perineum, inguinal 
(groin) region, and axillae (underarms). Chronic skin lesions may 
result in functional limitations as described in 108.00D2.
    3. Contractures: Contractures are permanent fibrous scar tissue 
resulting in tightening and thickening of skin that prevents normal 
movement of the damaged area. They can develop on any part of your 
musculoskeletal system, including upper extremities, lower 
extremities, palms of your hands, soles of your feet, the perineum, 
inguinal (groin) region, and axillae (underarms). Contractures may 
result in functional limitations as described in 108.00D2.
    4. Documented medical need: When we use the term ``documented 
medical need,'' we mean that there is evidence (see Sec.  416.913 of 
this chapter) from your medical source(s) in the medical record that 
supports your need for an assistive device (see 108.00B1) for a 
continuous period of at least 12 months. The evidence must include 
documentation from your medical source(s) describing any 
limitation(s) in your upper or lower extremity functioning that 
supports your need for the assistive device and describing the 
circumstances for which you need it. The evidence does not have to 
include a specific prescription for the device.
    5. Fine and gross movements: Fine movements, for the purposes of 
these listings, involve use of your wrists, hands, and fingers; such 
movements include picking, pinching, manipulating, and fingering. 
Gross

[[Page 37745]]

movements involve use of your shoulders, upper arms, forearms, and 
hands; such movements include handling, gripping, grasping, holding, 
turning, and reaching. Gross movements also include exertional 
activities such as lifting, carrying, pushing, and pulling. 
Evaluation of fine and gross movements is dependent on your age.
    6. Surgical management: For the purposes of these listings, 
surgical management includes the surgery(ies) itself, as well as 
various post-surgical procedures, surgical complications, infections 
or other medical complications, related illnesses, or related 
treatments that delay a person's attainment of maximum benefit from 
surgery.
    7. Exacerbation: For the purposes of these listings, 
exacerbation means an increase in the signs or symptoms of the skin 
disorder. Exacerbation may also be referred to as flare, flare-up, 
or worsening of the skin disorder.
    C. What evidence do we need to evaluate your skin disorder?
    1. To establish the presence of a skin disorder as a medically 
determinable impairment, we need objective medical evidence from an 
acceptable medical source (AMS) who has examined you for the 
disorder.
    2. We will make every reasonable effort to obtain your medical 
history, treatment records, and relevant laboratory findings, but we 
will not purchase genetic testing.
    3. When we evaluate the presence and severity of your skin 
disorder(s), we generally need information regarding:
    a. The onset, duration, and frequency of exacerbations (see 
108.00B7);
    b. The prognosis of your skin disorder;
    c. The location, size, and appearance of lesions and 
contractures;
    d. Any available history of familial incidence;
    e. Your exposure to toxins, allergens or irritants; seasonal 
variations; and stress factors;
    f. Your ability to function outside of a highly protective 
environment (see 108.00E4);
    g. Laboratory findings (for example, a biopsy obtained 
independently of Social Security disability evaluation or results of 
blood tests);
    h. Evidence from other medically acceptable methods consistent 
with the prevailing state of medical knowledge and clinical 
practice; and
    i. Statements you or others make about your disorder(s), your 
restrictions, and your daily activities.
    D. How do we evaluate the severity of skin disorders? 1. 
General. We evaluate the severity of skin disorders based on the 
site(s) of your chronic skin lesions (see 108.00B2) or contractures 
(see 108.00B3), functional limitations caused by your signs and 
symptoms (including pain) (see 108.00D2), and how your prescribed 
treatment affects you. We consider the frequency and severity of 
your exacerbations (see 108.00B7), how quickly they resolve, and how 
you function between exacerbations (see 108.00B7), to determine 
whether your skin disorder meets or medically equals a listing (see 
108.00D3). If there is no record of ongoing medical treatment for 
your disorder, we will follow the guidelines in 108.00D6. We will 
determine the extent and kinds of evidence we need from medical and 
non-medical sources based on the individual facts about your 
disorder. For our basic rules on evidence, see Sec. Sec.  416.912, 
416.913, and 416.920b of this chapter. For our rules on evaluating 
your symptoms, see Sec.  416.929 of this chapter.
    2. Limitation(s) of physical functioning due to skin disorders.
    a. Skin disorders may be due to chronic skin lesions (see 
108.00B2) or contractures (see 108.00B3), and may cause pain or 
restrict movement, which can limit your ability to initiate, 
sustain, and complete age-appropriate activities. For example, skin 
lesions in the axilla may limit your ability to raise or reach with 
the affected arm, or lesions in the inguinal region may limit your 
ability to ambulate, sit, or lift and carry. To evaluate your skin 
disorder(s) under 108.07B, 108.08, and 108.09, we require medically 
documented evidence of physical limitation(s) of functioning related 
to your disorder. The decrease in physical function must have 
lasted, or can be expected to last, for a continuous period of at 
least 12 months (see Sec.  416.909 of this chapter). Xeroderma 
pigmentosum is the only skin disorder that does not include 
functional criteria because the characteristics and severity of the 
disorder itself are sufficient to meet the criteria in 108.07A.
    b. The functional criteria require impairment-related physical 
limitations in using upper or lower extremities that have lasted, or 
can be expected to last, for a continuous period of at least 12 
months, medically documented by one of the following:
    (i) Inability to use both upper extremities to the extent that 
neither can be used to independently initiate, sustain, and complete 
age-appropriate activities involving fine and gross movements (see 
108.00B5) due to chronic skin lesions (see 108.00B2) or contractures 
(see 108.00B3); or
    (ii) Inability to use one upper extremity to independently 
initiate, sustain, and complete age-appropriate activities involving 
fine and gross movements (see 108.00B5) due to chronic skin lesions 
(see 108.00B2) or contractures (see 108.00B3), and a documented 
medical need (see 108.00B4) for an assistive device (see 108.00B1) 
that requires the use of the other upper extremity; or
    (iii) Inability to stand up from a seated position and maintain 
an upright position to the extent needed to independently initiate, 
sustain, and complete age-appropriate activities due to chronic skin 
lesions (see 108.00B2) or contractures (see 108.00B3) affecting at 
least two extremities (including when the limitations are due to 
involvement of the perineum or the inguinal region); or
    (iv) Inability to maintain an upright position while standing or 
walking to the extent needed to independently initiate, sustain, and 
complete age-appropriate activities due to chronic skin lesions (see 
108.00B2) or contractures (see 108.00B3) affecting both lower 
extremities (including when the limitations are due to involvement 
of the perineum or the inguinal region).
    3. Frequency of exacerbations due to chronic skin lesions. A 
skin disorder resulting in chronic skin lesions (see 108.00B2) may 
have frequent exacerbations (see 108.00B7) severe enough to meet a 
listing even if each individual skin lesion exacerbation (see 
108.00B7) did not last for an extended amount of time. We will 
consider the frequency, severity, and duration of skin lesion 
exacerbations (see 108.00B7), how quickly they resolve, and how you 
function in the time between skin lesion exacerbations (see 
108.00B7), to determine whether your skin disorder meets or 
medically equals a listing.
    4. Symptoms (including pain). Your symptoms may be an important 
factor in our determination of whether your skin disorder(s) meets 
or medically equals a listing. We consider your symptoms only when 
you have a medically determinable impairment(s) that could 
reasonably be expected to produce the symptoms. See Sec.  416.929 of 
this chapter.
    5. Treatment.
    a. General. Treatments for skin disorders may have beneficial or 
adverse effects, and responses to treatment vary from person to 
person. Your skin disorder's response to treatment may vary due to 
treatment resistance or side effects that can result in functional 
limitations. We will evaluate all of the effects of treatment 
(including surgical treatment, medications, and therapy) on the 
symptoms, signs, and laboratory findings of your skin disorder, and 
on your ability to function.
    b. Despite adherence to prescribed medical treatment for 3 
months. Under 108.09, we require that your symptoms persist 
``despite adherence to prescribed medical treatment for 3 months.'' 
This requirement means that you must have taken prescribed 
medication(s) or followed other medical treatment prescribed by a 
medical source for 3 consecutive months. Treatment or effects of 
treatment may be temporary. In most cases, sufficient time must 
elapse to allow us to evaluate your response to treatment, including 
any side effects. For our purposes, ``sufficient time'' means a 
period of at least 3 months. If your treatment has not lasted for at 
least 3 months, we will follow the rules in 108.00D6a. The 3 months 
adherence to prescribed medical treatment must be within the period 
of at least 12 months that we use to evaluate severity.
    c. Treatment with PUVA (psoralen and ultraviolet A (UVA) light) 
or biologics. If you receive additional treatment with PUVA or 
biologics to treat your skin disorder(s), we will defer adjudication 
of your claim for 6 months from the start of treatment with PUVA or 
biologics to evaluate the effectiveness of these treatments unless 
we can make a fully favorable determination or decision on another 
basis.
    6. No record of ongoing treatment.
    a. Despite having a skin disorder, you may not have received 
ongoing treatment, may have just begun treatment, may not have 
access to prescribed medical treatment, or may not have an ongoing 
relationship with the medical community. In any of these situations, 
you will not have a longitudinal medical record for us to review 
when we

[[Page 37746]]

evaluate your disorder. In some instances, we may be able to assess 
the severity and duration of your skin disorder based on your 
medical record and current evidence alone. We may ask you to attend 
a consultative examination to determine the severity and potential 
duration of your skin disorder (see Sec.  416.919a of this chapter).
    b. If, for any reason, you have not received treatment, your 
skin disorder cannot meet the criteria for 108.09. If the 
information in your case record is not sufficient to show that you 
have a skin disorder that meets the criteria of one of the skin 
disorders listings, we will follow the rules in 108.00I.
    E. How do we evaluate genetic photosensitivity disorders under 
108.07? Genetic photosensitivity disorders are disorders of the skin 
caused by an increase in the sensitivity of the skin to sources of 
ultraviolet light, including sunlight.
    1. Xeroderma pigmentosum (XP) (108.07A). XP is a genetic 
photosensitivity disorder with lifelong hypersensitivity to all 
forms of ultraviolet light. Laboratory testing confirms the 
diagnosis by documenting abnormalities in the body's ability to 
repair DNA (deoxyribonucleic acid) mutations after ultraviolet light 
exposure. Your skin disorder meets the requirements of 108.07A if 
you have clinical and laboratory findings supporting a diagnosis of 
XP (see 108.00E3).
    2. Other genetic photosensitivity disorders (108.07B). The 
effects of other genetic photosensitivity disorders may vary and may 
not persist over time. To meet the requirements of 108.07B, a 
genetic photosensitivity disorder other than XP must be established 
by clinical and laboratory findings (see 108.00C) and must result 
either in chronic skin lesions (see 108.00B2) or contractures (see 
108.00B3) that result in functional limitations (108.00D2), or must 
result in the inability to function outside of a highly protective 
environment (see 108.00E4). Some genetic photosensitivity disorders 
can have very serious effects on other body systems, especially 
special senses and speech, neurological, mental, and cancer. We will 
evaluate your disorder(s) under the listings in 102.00, 111.00, 
112.00, or 113.00, as appropriate. 3. What evidence do we need to 
document that you have XP or another genetic photosensitivity 
disorder? We will make a reasonable effort to obtain evidence of 
your disorder(s), but we will not purchase genetic testing. When the 
results of genetic tests are part of the existing evidence in your 
case record, we will evaluate the test results with all other 
relevant evidence. We need the following clinical and laboratory 
findings to document that you have XP or another genetic 
photosensitivity disorder:
    a. A laboratory report of a definitive genetic test documenting 
appropriate chromosomal changes, including abnormal DNA repair or 
another DNA abnormality specific to your type of photosensitivity 
disorder, signed by an AMS; or
    b. A laboratory report of a definitive test that is not signed 
by an AMS, and a report from an AMS stating that you have undergone 
definitive genetic laboratory studies documenting appropriate 
chromosomal changes, including abnormal DNA repair or another DNA 
abnormality specific to your type of photosensitivity disorder; or
    c. If we do not have a laboratory report of a definitive test, 
we need documentation from an AMS that an appropriate laboratory 
analysis or other diagnostic method(s) confirms a positive diagnosis 
of your skin disorder. This documentation must state that you had 
the appropriate definitive laboratory test(s) for diagnosing your 
disorder and provide the results, or explain how another diagnostic 
method(s), consistent with the prevailing state of medical knowledge 
and clinical practice, established your diagnosis.
    4. Inability to function outside of a highly protective 
environment means that you must avoid exposure to ultraviolet light 
(including sunlight passing through windows and light from similar 
unshielded light sources), wear protective clothing and eyeglasses, 
and use opaque broad-spectrum sunscreens in order to avoid skin 
cancer or other serious effects.
    F. How do we evaluate burns under 108.08?
    1. Electrical, chemical, or thermal burns frequently affect 
other body systems; for example, musculoskeletal, special senses and 
speech, respiratory, cardiovascular, genitourinary, neurological, or 
mental. We evaluate burns in the same way we evaluate other 
disorders that can affect the skin and other body systems, using the 
listing for the predominant feature of your disorder. For example, 
if your soft tissue injuries resulting from burns are under surgical 
management (as defined in 108.00B6), we will evaluate your disorder 
under the listings in 101.00.
    2. We evaluate burns resulting in chronic skin lesions (see 
108.00B2) or contractures (see 108.00B3) that have been documented 
by an AMS to have reached maximum therapeutic benefit and therefore 
are no longer receiving surgical management, under 108.08. To be 
disabling, these burns must result in functional limitation(s) (see 
108.00D2) that has lasted or can be expected to last for a 
continuous period of at least 12 months.
    G. How do we evaluate chronic conditions of the skin or mucous 
membranes under 108.09? We evaluate skin disorders that result in 
chronic skin lesions (see 108.00B2) or contractures (see 108.00B3) 
under 108.09. These disorders must result in chronic skin lesions 
(see 108.00B2) or contractures (see 108.00B3) that continue to 
persist despite adherence to prescribed medical treatment for 3 
months (see 108.00D5b) and cause functional limitations (see 
108.00D2). Examples of skin disorders evaluated under this listing 
are ichthyosis, bullous diseases (such as pemphigus, epidermolysis 
bullosa, and dermatitis herpetiformis), chronic skin infections, 
dermatitis, psoriasis, and hidradenitis suppurativa.
    H. How do we evaluate disorders in other body systems that 
affect the skin? When your disorder(s) in another body system 
affects your skin, we first evaluate the predominant feature of your 
disorder(s) under the appropriate body system. Examples of disorders 
in other body systems that affect the skin include the following:
    1. Tuberous sclerosis. The predominant functionally limiting 
features of tuberous sclerosis are seizures and intellectual 
disorder or other mental disorders. We evaluate these features under 
the listings in 111.00 or 112.00, as appropriate.
    2. Malignant tumors of the skin. Malignant tumors of the skin 
(for example, malignant melanomas) are cancers, or malignant 
neoplastic diseases, that we evaluate under the listings in 113.00.
    3. Immune system disorders. We evaluate skin manifestations of 
immune system disorders such as systemic lupus erythematosus, 
scleroderma, psoriasis, and human immunodeficiency virus (HIV) 
infection under the listings in 114.00.
    4. Head or facial disfigurement or deformity, and other physical 
deformities caused by skin disorders. A head or facial disfigurement 
or deformity may result in loss of your sight, hearing, speech, or 
ability to chew. In addition to head and facial disfigurement and 
deformity, other physical deformities may result in associated 
psychological problems (for example, depression). We evaluate the 
effects of head or facial disfigurement or deformity, or other 
physical deformities caused by skin disorders under the listings in 
101.00, 102.00, 105.00, or 112.00, as appropriate.
    5. Porphyria. We evaluate erythropoietic protoporphyria under 
the listings in 107.00.
    6. Hemangiomas. We evaluate hemangiomas associated with 
thrombocytopenia and hemorrhage (for example, Kasabach-Merritt 
syndrome) involving coagulation defects under the listings in 
107.00. When hemangiomas impinge on vital structures or interfere 
with functioning, we evaluate their primary effects under the 
listings in the appropriate body system.
    I. How do we evaluate skin disorders that do not meet one of 
these listings?
    1. These listings are only examples of common skin disorders 
that we consider severe enough to result in marked and severe 
limitations. If your impairment(s) does not meet the criteria of any 
of these listings, we must also consider whether you have an 
impairment(s) that satisfies the criteria of a listing in another 
body system.
    2. If you have a severe medically determinable impairment(s) 
that does not meet a listing, we will determine whether your 
impairment(s) medically equals a listing. See Sec.  416.926 of this 
chapter. If your impairment(s) does not meet or medically equal a 
listing, we will also consider whether your impairment(s) 
functionally equals the listings. See Sec.  416.926a of this 
chapter. We use the rules in Sec.  416.994a of this chapter when we 
decide whether you continue to be disabled.
    108.01 Category of Impairments, Skin Disorders
    108.02-108.06 [Reserved]
    108.07 Genetic photosensitivity disorders, established as 
described in 108.00E. The requirements of this listing are met if 
either paragraph A or paragraph B is satisfied.
    A. Xeroderma pigmentosum (see 108.00E1).

OR

    B. Other genetic photosensitivity disorders (see 108.00E2) with 
either 1 or 2:
    1. Chronic skin lesions (see 108.00B2) or contractures (see 
108.00B3) that cause an

[[Page 37747]]

inability to function outside of a highly protective environment 
(see 108.00E4); or
    2. Chronic skin lesions (see 108.00B2) or contractures (see 
108.00B3) causing chronic pain or other physical limitation(s) that 
result in impairment-related functional limitations (see 108.00D2), 
as evidenced by:
    a. Inability to use both upper extremities to the extent that 
neither can be used to independently initiate, sustain, and complete 
age-appropriate activities involving fine and gross movements (see 
108.00B5) due to chronic skin lesions (see 108.00B2) or contractures 
(see 108.00B3); or
    b. Inability to use one upper extremity to independently 
initiate, sustain, and complete age-appropriate activities involving 
fine and gross movements (see 108.00B5) due to chronic skin lesions 
(see 108.00B2) or contractures (see 108.00B3), and a documented 
medical need (see 108.00B4) for an assistive device (see 108.00B1) 
that requires the use of the other upper extremity; or
    c. Inability to stand up from a seated position and maintain an 
upright position to the extent needed to independently initiate, 
sustain, and complete age-appropriate activities due to chronic skin 
lesions (see 108.00B2) or contractures (see 108.00B3) affecting at 
least two extremities (including when the 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 age-appropriate activities due to chronic skin lesions (see 
108.00B2) or contractures (see 108.00B3) affecting both lower 
extremities (including when the limitations are due to involvement 
of the perineum or the inguinal region).
    108.08 Burns (see 108.00F). Burns that do not require continuing 
surgical management (see 108.00B6), or that have been documented by 
an acceptable medical source to have reached maximum therapeutic 
benefit and are no longer receiving surgical management, resulting 
in chronic skin lesions (see 108.00B2) or contractures (see 
108.00B3) causing chronic pain or other physical limitation(s) that 
result in impairment-related functional limitations (see 108.00D2), 
as evidenced by:
    A. Inability to use both upper extremities to the extent that 
neither can be used to independently initiate, sustain, and complete 
age-appropriate activities involving fine and gross movements (see 
108.00B5) due to chronic skin lesions (see 108.00B2) or contractures 
(see 108.00B3).

OR

    B. Inability to use one upper extremity to independently 
initiate, sustain, and complete age-appropriate activities involving 
fine and gross movements (see 108.00B5) due to chronic skin lesions 
(see 108.00B2) or contractures (see 108.00B3), and a documented 
medical need (see 108.00B4) for an assistive device (see 108.00B1) 
that requires the use of the other upper extremity.

OR

    C. Inability to stand up from a seated position and maintain an 
upright position to the extent needed to independently initiate, 
sustain, and complete age-appropriate activities due to chronic skin 
lesions (see 108.00B2) or contractures (see 108.00B3) affecting at 
least two extremities (including when the 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 age-appropriate activities due to chronic skin lesions (see 
108.00B2) or contractures (see 108.00B3) affecting both lower 
extremities (including when the limitations are due to involvement 
of the perineum or the inguinal region).
    108.09 Chronic conditions of the skin or mucous membranes (see 
108.00G) resulting in:
    A. Chronic skin lesions (see 108.00B2) or contractures (see 
108.00B3) causing chronic pain or other physical limitation(s) that 
persist despite adherence to prescribed medical treatment for 3 
months (see 108.00D5b).

AND

    B. Impairment-related functional limitations (see 108.00D2) 
demonstrated by 1, 2, 3, or 4:
    1. Inability to use both upper extremities to the extent that 
neither can be used to independently initiate, sustain, and complete 
age-appropriate activities involving fine and gross movements (see 
108.00B5) due to chronic skin lesions (see 108.00B2) or contractures 
(see 108.00B3); or
    2. Inability to use one upper extremity to independently 
initiate, sustain, and complete age-appropriate activities involving 
fine and gross movements (see 108.00B5) due to chronic skin lesions 
(see 108.00B2) or contractures (see 108.00B3), and a documented 
medical need (see 108.00B4) for an assistive device (see 108.00B1) 
that requires the use of the other upper extremity; or
    3. Inability to stand up from a seated position and maintain an 
upright position to the extent needed to independently initiate, 
sustain, and complete age-appropriate activities due to chronic skin 
lesions (see 108.00B2) or contractures (see 108.00B3) affecting at 
least two extremities (including when the limitations are due to 
involvement of the perineum or the inguinal region); or
    4. Inability to maintain an upright position while standing or 
walking to the extent needed to independently initiate, sustain, and 
complete age-appropriate activities due to chronic skin lesions (see 
108.00B2) or contractures (see 108.00B3) affecting both lower 
extremities (including when the limitations are due to involvement 
of the perineum or the inguinal region).
* * * * *

114.00 Immune System Disorders

* * * * *
    F. * * *
    7. * * *
    b. * * *
    (iii) BMI is the ratio of a child's weight to the square of his 
or her height. We calculate BMI using the formulas in the digestive 
disorders body system (105.00).
* * * * *
[FR Doc. 2023-11771 Filed 6-7-23; 8:45 am]
BILLING CODE 4191-02-P