# Revised Medical Criteria for Evaluating Digestive Disorders and Skin Disorders

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/fr%3A2023-11771

## Record

- **Collection:** Federal Register
- **Document type:** Rule
- **Published:** June 8, 2023
- **Citation:** 88 FR 37704

## Text

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.

7
84 FR 35936 (2019).

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

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.

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 for the digestive system prior to the effective date of this Final Rule

Revised sections of the Adult Introductory Text and Listings for digestive
disorders

Introductory Text, 5.00

A. What kinds of disorders do we consider in the digestive system?
A. Which digestive disorders do we evaluate in this body 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 of treatment?
[5.00 H.]

D. How do we evaluate chronic liver disease?
C. What is chronic liver disease (CLD), and how do we evaluate it under 5.05?

E. How do we evaluate inflammatory bowel disease (IBD)?
D. What is inflammatory bowel disease (IBD), and how do we evaluate it under 5.06?

F. How do we evaluate short bowel syndrome (SBS)?
E. What is intestinal failure and how do we evaluate it under 5.07?

G. How do we evaluate weight loss due to any digestive disorder?
F. How do we evaluate weight loss due 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 “consider under a disability for 1 year”?
[5.00 C.2. and G.]

[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 that do not meet one of the digestive disorder listings?
J. How do we evaluate digestive disorders that do not meet one of these listings?

Listings

5.01 Category of Impairments, Digestive System
5.01 Category of Impairments, Digestive Disorders

5.02 Gastrointestinal hemorrhaging from any cause, requiring blood transfusion
5.02 Gastrointestinal hemorrhaging from any cause, requiring three 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 (IBD)
5.06 Inflammatory bowel disease (IBD)

5.07 Short bowel syndrome (SBS)
5.07 Intestinal failure

5.08 Weight loss due to any digestive disorder
5.08 Weight loss due to any digestive 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 for the digestive system prior to the effective date of this final rule

Revised sections of the Childhood Introductory Text and listings for digestive
disorders

Introductory Text, 105.00

A. What kinds of disorders do we consider in the digestive system?
A. Which digestive disorders do we evaluate in this body 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 of treatment?
[105.00 J.]

D. How do we evaluate chronic liver disease?
C. What is chronic liver disease (CLD), and how do we evaluate it under 105.05?

E. How do we evaluate inflammatory bowel disease (IBD)?
D. What is inflammatory bowel disease (IBD), and how do we evaluate it under 105.06?

F. How do we evaluate short bowel syndrome (SBS)?
E. What is intestinal failure, and how do we evaluate it under 105.07?

G. How do we evaluate growth failure due to any digestive disorder?
F. How do we evaluate growth failure due to any digestive disorder under 105.08?

[105.00 D.13.]
G. How do we evaluate digestive organ transplantation?

H. How do we evaluate the need for supplemental daily enteral feeding via a gastrostomy?
H. How do we evaluate the need for supplemental daily enteral feeding via a gastrostomy, duodenostomy, or jejunostomy?

I. How do we evaluate esophageal stricture or stenosis?
I. How do we evaluate esophageal stricture or stenosis?

J. What do we mean by the phrase “consider under a disability for 1 year”?
[105.00 C.2., C.4., and G.]

[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 that do not meet one of the digestive disorder listings?
L. How do we evaluate digestive disorders that do not meet one of these listings?

Listings

105.01 Category of Impairments, Digestive System
105.01 Category of Impairments, Digestive Disorders

105.02 Gastrointestinal hemorrhaging from any cause, requiring blood transfusion
105.02 Gastrointestinal hemorrhaging from any cause, requiring three 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 (IBD)
105.06 Inflammatory bowel disease (IBD)

105.07 Short bowel syndrome (SBS)
105.07 Intestinal failure

105.08 Growth failure due to any digestive disorder
105.08 Growth failure due to any digestive disorder

105.09 Liver transplantation
105.09 Liver transplantation

105.10 Need for supplemental daily enteral feeding via a gastrostomy

105.10 Need for supplemental daily enteral feeding via a 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.

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 final rule
Revised listing criteria
Rationale
Resources

5.02/105.02 Gastrointestinal hemorrhaging from any cause, requiring blood transfusion (with or without hospitalization) of at least 2 units of blood per transfusion (or at least 10 cc of blood/kg of body weight per transfusion for children), and occurring at least three times during a consecutive 6-month-period. The transfusions must be at least 30 days apart within the 6-month period
5.02/105.02 Gastrointestinal hemorrhaging from any cause, requiring three blood transfusions of at least 2 units of blood per transfusion, or at least 10 cc of blood/kg of body weight per transfusion, within a consecutive 12-month period and at least 30 days apart
The revised text is more consistent with our statutory definition of disability; that is, the inability to do any substantial gainful activity by reason of any medically determinable physical or mental impairment which can be expected to result in death or which has lasted or can be expected to last for a continuous period of not less than 12 months
Section 223(d)(1)(A) of the Social Security Act.

5.05B/105.05B Chronic liver disease, with:
Ascites or hydrothorax not attributable to other causes, despite continuing treatment as prescribed, present on at least 2 evaluations at least 60 days apart within a consecutive 6-month period. Each evaluation must be documented by:

5.05B/105.05B Chronic liver disease (CLD) (see 5.00C) with A, B, C, D, E, F, or G:
Ascites or hydrothorax not attributable to other causes (see 5.00C2b and 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:

5.05F/105.05F Chronic liver disease, with:

Hepatic encephalopathy as described in
5.00D10,
with 1 and either 2 or 3:

1. Documentation of abnormal behavior, cognitive dysfunction, changes in mental status, or altered state of consciousness (for example, confusion, delirium, stupor, or coma), present on at least two evaluations at least 60 days apart within a consecutive 6-month period;
3. One of the following occurring on at least two evaluations at least 60 days apart within the same consecutive 6-month period as in F1:

5.05F/105.05F Chronic liver disease (CLD) (see 5.00C) with A, B, C, D, E, F, or G:
Hepatic encephalopathy (see 5.00C2f and 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:
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 with SSA CLD scores of 22 or greater calculated as described in
5.00D11

5.05G/105.05G Two SSA CLD scores (see 5.00C3) of at least 20 within a consecutive 12-month period and at least 60 days apart

5.06/105.06 Inflammatory bowel disease (IBD) documented by endoscopy, biopsy, appropriate medically acceptable imaging, or operative findings with:
A. Obstruction of stenotic areas (not adhesions) in the small intestine or colon with proximal dilatation, confirmed by appropriate medically acceptable imaging or in surgery, requiring hospitalization for intestinal decompression or for surgery, and occurring on at least two occasions at least 60 days apart within a consecutive 6-month period;
OR
B. Two of the following despite continuing treatment as prescribed and occurring within the same consecutive 6-month period:

5.06/105.06 Inflammatory bowel disease (IBD) (see 5.00D/105.00D) 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:

5.08 Weight loss due to any digestive disorder despite continuing treatment as prescribed, with body mass index (BMI) of less than 17.50 calculated on at least two evaluations at least 60 days apart within a consecutive 6-month period
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

Adult and Childhood Digestive Disorders Listings Criteria—Changes in Healthcare Utilization Introductory Text—5.00/105.00

Introductory Text or Listing Criteria Prior to the Effective Date of This Final Rule
Revised Introductory Text or Listing Criteria
Rationale
Resources

5.00D/105.00D (How do we evaluate chronic liver disease)

11. End stage liver disease (ESLD) documented by scores from the SSA Chronic Liver Disease (SSA CLD) calculation (
5.05G/105.05G1
).

b. To calculate the SSA CLD score, we use a formula that includes three laboratory values: Serum total bilirubin (mg/dL), serum creatinine (mg/dL), and International Normalized Ratio (INR).

5.00/105.00C (What is chronic liver disease (CLD) and how do we evaluate it?)

3. SSA Chronic Liver Disease (SSA CLD) score (5.05G/105.05G
9
). 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).

The revised introductory text adds serum sodium, to be considered under certain conditions, in the CLD formula. The Model for End-Stage Liver Disease (MELD) formula, from which the CLD formula is based and is the mathematical equivalent to, was updated in 2016 to add the serum sodium levels. We added serum sodium levels because, for individuals with certain liver conditions such as alcoholic hepatitis and cirrhosis, medical research shows serum sodium levels predict negative outcomes more accurately than formulas without it.

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.
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.

Londoño, M.-C., Cárdenas, A., Guevara, M., Quintó, L., de las Heras, D., Navasa, M., Rimola, A., Garcia-Valdecasas, J.-C., Arroya, V., & Ginès, 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.

Listing 5.05/105.05 Chronic Liver Disease (CLD)

5.05G/105.05G End stage liver disease with SSA CLD scores of 22 or greater calculated as described in
5.00D11
.

5.05G/105.05G Two SSA CLD scores (see 5.00C3) of at least 20 within a consecutive 12-month period and at least 60 days apart.
The revised listing reduces the current listing level end stage liver disease CLD score of 22 to 20. Two scores of at least 20 accurately identify advanced, end stage liver disease that prevents a person from working and, without a liver transplant, will ultimately result in death. The unchanged requirement of a second score at least 60 days after the first score is to confirm chronicity, which is critical for confirming continued severity. We have also modified this score for children above the age of 12 in the childhood listing (see 105.05G2).

Annamalai, A., Harada, M., Chen, M., Tran, T., Ko, A., Ley, E., . . . Noureddin, M. (2016). Predictors of mortality in the critically ill cirrhotic patient: Is the model for end-stage liver disease enough? Journal of the American College of Surgeons, 224(3), 276-282.
https://doi.org/10.1016/j.jamcollsurg.2016.11.005
.

Zhiang, E., Zhang, Z., Want, S., Xiao, Z., Gu, J., Xiong, M., . . . Huang, Z. (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
.

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 hospitalization status. Journal of Hepatology, 63(3), 601-608.
https://www.sciencedirect.com/science/article/pii/S0168827815002445?via%3Dihub
.

Listing 5.06/105.06 Inflammatory Bowel Disease (IBD)

5.06B/105.06B Inflammatory bowel disease (IBD) documented by endoscopy, biopsy, appropriate medically acceptable imaging, or operative findings with:
Two of the following despite continuing treatment as prescribed and occurring within the same consecutive 6-month period:
3. Clinically documented tender abdominal mass palpable on physical examination with abdominal pain or cramping that is not completely controlled by prescribed narcotic medication, present on at least two evaluations at least 60 days apart; or
4. Perineal disease with a draining abscess or fistula, with pain that is not completely controlled by prescribed narcotic medication, present on at least two evaluations at least 60 days apart; or

5.06B/105.06B Inflammatory bowel disease (IBD) (see 5.00D and 105.00D) documented by endoscopy, biopsy, imaging, or operative findings, and demonstrated by A, B, or C:
Two of the following occurring within a consecutive 12-month period and at least 60 days apart:
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

The revised listing text removes the requirement that pain not be completely controlled by prescribed narcotic medication. 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. In subregulatory policy, we also include the “risk of addiction to opioid medication” as an example of a “good cause” reason for not following prescribed treatment.” Since 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, we removed consideration of narcotic medication from these listings.

20 CFR 404.1530 and 416.930. Need to follow prescribed treatment.
SSR 18-3p: Titles II and XVI: Failure to Follow Prescribed Treatment.

5.06B/105.06B Inflammatory bowel disease (IBD) documented by endoscopy, biopsy, appropriate medically acceptable imaging, or operative findings with:
6 (5 for childhood). Need for supplemental daily enteral nutrition via a gastrostomy or daily parenteral nutrition via a central venous catheter.

5.06B/105.06B Inflammatory bowel disease (IBD) (see 5.00D and 105.00D) documented by endoscopy, biopsy, imaging, or operative findings, and demonstrated by A, B, or C:
5. Need for supplemental daily enteral nutrition via a gastrostomy, duodenostomy, or jejunostomy, or daily parenteral nutrition via a central venous catheter.

The revised listing expands the alternative method of supplemental daily enteral nutrition to meet the listing to include duodenostomy and jejunostomy. We added these two additional methods of tube feeding after we received public comment requesting that we expand tube feedings to those beyond gastric which are often required in patients with digestive disorders.

Public comment:
https://www.regulations.gov/comment/SSA-2017-0042-0008
.

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
.

Brett, K. & Argáez, 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.

Clinical Nutrition University. (2021, May 25).
Types of Feeding Tubes EXPLAINED
. YouTube.
https://www.youtube.com/watch?v=4Oam1yUHiO8
.

No current listing criteria

5.06C Repeated complications of IBD (see 5.00D5a), occurring an average of three 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).

The revised listing combines required medical findings with specific limitations in functioning to identify IBD of listing-level severity. Specifically, the revised listing adds a criterion for repeated complications of IBD that result in marked limitation in at least one area of functioning. This combination of findings accurately characterizes complications of IBD that prevent a person from engaging in any gainful activity.
The addition of functional criteria is also consistent with the listings that already include these same functional criteria, which are 7.18 (Repeated complications of hematological disorders), 14.02B (Repeated manifestations of systemic lupus erythematosus), 14.04D (Repeated manifestations of systemic sclerosis), 14.05E (Repeated manifestations of polymyositis or dermatomyositis), 14.06B (Repeated 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 (Sjögren's syndrome), and 14.11I (Repeated manifestations of HIV infection).

Farraye, F.A., Melmed, G.Y., Lichtenstein, G.R., & Kane, S.V. (2017). ACG clinical guidelines: Preventative care in inflammatory bowel disease. American Journal of Gastroenterology, 112(2), 241-258.
Gajendran, M., Loganathan, P., Catinella, A.P., & Hashash, J.G. (2018). A comprehensive review and update on Crohn's disease. Disease-a-Month, 64, 20-57.
Rubin, D.T., Ananthakrishnan, A.N., Siegel, C.A., Sauer, B.G., & Long, M.D. (2019). ACG clinical guidelines: Ulcerative colitis in adults. American Journal of Gastroenterology, 114(3), 384-413.
Yarur, A.J., Strobel, S.G., Deshpande, A.R., & Abreu, M.T. (2011). Predictors of aggressive inflammatory bowel disease. Gastroenterology & Hepatology, 7(10), 652-659.

Listing 5.07/105.07 Intestinal Failure

5.07/105.07 Short bowel syndrome (SBS), due to surgical resection of more than one-half of the small intestine, with dependence on daily parenteral nutrition via a central venous catheter (see
5.00F
).

5.07/105.07 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.
The revised listing more broadly addresses intestinal failure with need for parenteral nutrition and covers a greater range of chronic dysmotility or absent motility disorders. We adopted a public comment requesting this change to account for individuals who have intestinal conditions that may exist without the surgery requirement of short bowel syndrome (the current listing).

Public comment:
https://www.regulations.gov/comment/SSA-2017-0042-0015
.

Thompson J.S., Rochling FA, Weseman R.A., Mercer D.F. Current management of short bowel syndrome.
Curr Probl Surg
49:52-115, 2012.
https://doi.org/10.1067/j.cpsurg.2011.10.002
.

Pironi, L., Arends, J., Baxter, J., Bozzetti, F., Peláez, R.B., Cuerda, C., Forbes, A., Gabe, S., Gillanders, L., Holst, M., Jeppesen, P.B., Joly, F., Kelly, D., Klek, S., Irtun, Ø., 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
.

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 gastroenterology, 36
(3), 223-229.
https://doi.org/10.1097/MOG.0000000000000631
.

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
.

Listing 105.10 Need for supplemental daily enteral feeding via a gastrostomy, duodenostomy, or jejunostomy

105.10 Need for supplemental daily enteral feeding via a gastrostomy due to any cause, for children who have not attained age 3; thereafter, evaluate the residual impairment(s) (see 105.00H).
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).
The revised listing expands the alternative method of supplemental daily enteral nutrition to meet the listing to include duodenostomy and jejunostomy. We added these two additional methods of tube feeding after we received public comment requesting that we expand tube feedings to those beyond gastric which are often required in patients with digestive disorders.

Public comment:
https://www.regulations.gov/comment/SSA-2017-0042-0008
.

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 for skin disorders prior to the effective date of this final rule
Revised sections of the Adult Introductory Text and Listings for Skin Disorders

Introductory Text, 8.00

A. What skin disorders do we evaluate with these listings?
A. Which skin disorders do we 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 of your skin disorder(s)?
[8.00D]

[8.00B]
C. What evidence do we need to evaluate your skin disorder?

D. How do we assess impairments that may affect the skin and other body systems?
[8.00H]

[8.00C]
D. How do we evaluate the severity of skin disorders?

E. How do we evaluate genetic photosensitivity disorders?
E. How do we evaluate genetic 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 skin disorder(s) will continue at a disabling level of severity in order to meet the duration requirement?
[8.00D]

[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 disorder(s) if your impairment does not meet the requirements of one of these listings?
[8.00I]

[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, Skin Disorders
8.01 Category of Impairments, Skin Disorders

8.02 Ichthyosis
8.02 [Reserved] [Now evaluated in 8.09]

8.03 Bullous disease
8.03 [Reserved] [Now evaluated in 8.09]

8.04 Chronic infections of the skin or mucous membranes
8.04 [Reserved] [Now evaluated in 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 disorders
8.07 Genetic photosensitivity 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 for skin disorders prior to the effective date of this final rule
Revised sections of the Childhood Introductory Text and listings for skin disorders

Introductory Text, 108.00

A. What skin disorders do we evaluate with these listings?
A. Which skin disorders do we 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 of your skin disorder(s)?
[108.00D]

[108.00B]
C. What evidence do we need to evaluate your skin disorder?

D. How do we assess impairments that may affect the skin and other body systems?
[108.00H]

[108.00C]
D. How do we evaluate the severity of skin disorders?

E. How do we evaluate genetic photosensitivity disorders?
E. How do we evaluate genetic 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 skin disorder(s) will continue at a disabling level of severity in order to meet the duration requirement?
[108.00D]

[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 disorder(s) if your impairment does not meet the requirements of one of these listings?
[108.00I]

[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, Skin Disorders
108.01 Category of Impairments, Skin 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 skin or mucous membranes
108.04 [Reserved] [Now evaluated in 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 disorders
108.07 Genetic photosensitivity 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.

Adult and Childhood Skin Disorders Listings Criteria—Changes in Healthcare Utilization and Condition/Episode Requirements

Introductory text or listing criteria prior to the effective date of this final rule

Revised Introductory text or listing
criteria

Rationale
Resources

Introductory Text—8.00/108.00

No current introductory text

8.00D5/108.00D5
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

The revised introductory text about deferment for PUVA treatment is supported by medical research. PUVA treatment involves exposure to UVA light after taking biologic medication called psoralen that increases the skin's sensitivity to ultraviolent light. PUVA is generally used under medical supervision when other conservative treatments for skin disorders have proven to be ineffective. We defer adjudication for 6 months from the start of treatment to assess the effectiveness of PUVA treatment on the skin condition

Farahnik, B., Nakamura, M., Singh, R.K., Abrouk, M., Zhu, T.H., Lee, K.M., . . . Liao, W. (2016). The patient's guide to psoriasis treatment. Part 2: PUVA phototherapy. Dermatology and Therapy, 6(3), 315-324.
https://doi.org/10.1007/s13555-016-0130-9.

Ong, S., & Venning, V. (2014). PUVA treatment information for patients. Retrieved from Oxford University Hospital NHS website:
https://www.ouh.nhs.uk/patient-guide/leaflets/files/120719puva.pdf.

Shenoi, S.D., & Prabhu, S. (2014). Photochemotherapy (PUVA) in psoriasis and vitiligo. Indian Journal of Dermatology, Venereology and Leprology, 80(6), 497-504.
https://doi.org/10.4103/0378-6323.144143
.

8.07/108.07 Genetic photosensitivity disorders

8.07/108.07 Genetic photosensitivity disorders, established as described in 8.00E
and 108.00E
B. Other genetic photosensitivity disorders, with:
1. Extensive skin lesions that have lasted or can be expected to last for a continuous period of at least 12 months,
OR

2. Inability to function outside of a highly protective environment for a continuous period of at least 12 months (see 8.00E2
and 108.00E2
)

8.07/108.07 Genetic photosensitivity disorders, established as described in 8.00E and 108.00E. The requirements of this listing are met if either paragraph A or paragraph B is satisfied
B. Other genetic photosensitivity disorders (see 8.00E2 and 108.00E2) with either 1 or 2:
2. Chronic skin lesions (see 8.00B2 and 108.00B2) or contractures (see 8.00B3 and 108.00B3) causing chronic pain or other physical limitation(s) that result in impairment-related functional limitations (see 8.00D2 and 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 work-related activities (or age-appropriate activities in childhood claims) involving fine and gross movements (see 8.00B5 and 108.00B5) due to chronic skin lesions (see 8.00B2 and 108.00B2) or contractures (see 8.00B3 and 108.00B3); or
b. Inability to use one upper extremity to independently initiate, sustain, and complete work-related activities (or age-appropriate activities in childhood claims) involving fine and gross movements (see 8.00B5 and 108.00B5) due to chronic skin lesions (see 8.00B2 and 108.00B2) or contractures (see 8.00B3 and 108.00B3), and a documented medical need (see 8.00B4 and 108.00B4) for an assistive device (see 8.00B1 and 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 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 at least two extremities (including when limitations are due to involvement of the perineum or the inguinal region); or

The requirement that the claimant's skin disorder results in significant functional limitations lasting a minimum of 12 months dates back to 1979.
10
The language in the revised listing 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
The revised functional criteria focus on the person's ability to use their upper and lower extremities to perform work-related activities or engage in age-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 “disorganization of motor function” in two extremities

44 FR 18170, 18187 (1979), 45 FR 55566, 55607 (1980), and 50 FR 50068, 50098 (1985).

Falder, S., Browne, A., Edgar, D., Staples, E., Fong, J., Rea, S., & Wood, F. (2009). Core outcomes for adult burn survivors: A clinical overview. Burns, 35(5), 618-641.
https://doi.org/10.1016/j.burns.2008.09.002
; Haslik, W., Kamolz, L., Manna, F., Hladik, M., Rath, T., & Frey, M. (2010). Management of full-thickness skin defects in the hand and wrist region: First long-term experiences with the dermal matrix Matriderm®. Journal of Plastic, Reconstructive & Aesthetic Surgery, 63(2), 360-364.
https://doi.org/10.1016/j.bjps.2008.09.026
; Wasiak, J., Lee, S., Paul, E., Mahar, P., Pfitzer, B., Spinks, A., . . . Gabbe, B. (2014). Predictors of health status and health-related quality of life 12 months after severe burn. Burns, 40(4), 568-574;

81 FR 43048 (2016).

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).

Listing 8.08/108.08 Burns

8.08/108.08 Burns, with extensive skin lesions that have lasted or can be expected to last for a continuous period of at least 12 months (see 8.00F
and 108.00F
)

8.08/108.08 Burns (see 8.00F and 108.00F). Burns that do not require continuing surgical management (see 8.00B6 and 108.00B6), 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 and 108.00B2) or contractures (see 8.00B3 and 108.00B3) causing chronic pain or other physical limitation(s) that result in impairment-related functional limitations (see 8.00D2 and 108.00D2), as evidenced by:
The functional criteria set forth above in listings 8.07B2a through d and 108.07B2a through d

The requirement that the claimant's skin disorder results in significant functional limitations lasting a minimum of 12 months dates back to 1979.
11
The language in the revised listing 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
The revised functional criteria, focus on the person's ability to use their upper and lower extremities to perform work-related activities or engage in age-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 “disorganization of motor function” in two extremities

44 FR 18170, 18187 (1979), 45 FR 55566, 55607 (1980), and 50 FR 50068, 50098 (1985).

Falder, S., Browne, A., Edgar, D., Staples, E., Fong, J., Rea, S., & Wood, F. (2009). Core outcomes for adult burn survivors: A clinical overview. Burns, 35(5), 618-641.
https://doi.org/10.1016/j.burns.2008.09.002
; Haslik, W., Kamolz, L., Manna, F., Hladik, M., Rath, T., & Frey, M. (2010). Management of full-thickness skin defects in the hand and wrist region: First long-term experiences with the dermal matrix Matriderm®. Journal of Plastic, Reconstructive & Aesthetic Surgery, 63(2), 360-364.
https://doi.org/10.1016/j.bjps.2008.09.026
; Wasiak, J., Lee, S., Paul, E., Mahar, P., Pfitzer, B., Spinks, A., . . . Gabbe, B. (2014). Predictors of health status and health-related quality of life 12 months after severe burn. Burns, 40(4), 568-574;

81 FR 43048 (2016).

Listing 8.09/108.09 Chronic conditions of the skin or mucous membranes

No current listing. Note that current listings 8.02/108.02 (Ichthyosis), 8.03/108/03 (Bullous disease), 8.04 (Chronic infections of the skin or mucous membranes), 8.05 (Dermatitis), and 8.06 (Hidradenitis suppurativa) all require extensive skin lesions that persist for at least 3 months despite continued treatment as prescribed. Under the revised skin disorders listings, all of these skin conditions will be evaluated under listing 8.09/108.09.

8.09/108.09 Chronic conditions of the skin or mucous membranes (see 8.00G and 108.00G) resulting in:
A. Chronic skin lesions (see 8.00B2 and 108.00B2) or contractures (see 8.00B3 and 108.00B3) causing chronic pain or other physical limitation(s) that persist despite adherence to prescribed medical treatment for 3 months (see 8.00D5b and 108.00D5b
AND
Impairment-related functional limitations demonstrated by the functional criteria set forth above in listings 8.07B2a through d and 108.07B2a through d.

We consolidated the current listings into one listing for adjudicative ease and to more efficiently capture adults and children with chronic skin conditions of listing-level severity.

The requirement that the claimant's skin disorder results in significant functional limitations lasting a minimum of 12 months dates back to 1979.
12
The language in the revised listing 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.

The revised functional criteria focus on the person's ability to use their upper and lower extremities to perform work-related activities or engage in age-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 “disorganization of motor function” in two extremities.

20 CFR 404.1509 and 416.909.
44 FR 18170, 18187 (1979), 45 FR 55566, 55607 (1980), and 50 FR 50068, 50098 (1985).

Falder, S., Browne, A., Edgar, D., Staples, E., Fong, J., Rea, S., & Wood, F. (2009). Core outcomes for adult burn survivors: A clinical overview. Burns, 35(5), 618-641.
https://doi.org/10.1016/j.burns.2008.09.002
; Haslik, W., Kamolz, L., Manna, F., Hladik, M., Rath, T., & Frey, M. (2010). Management of full-thickness skin defects in the hand and wrist region: First long-term experiences with the dermal matrix Matriderm®. Journal of Plastic, Reconstructive & Aesthetic Surgery, 63(2), 360-364.
https://doi.org/10.1016/j.bjps.2008.09.026
; Wasiak, J., Lee, S., Paul, E., Mahar, P., Pfitzer, B., Spinks, A., . . . Gabbe, B. (2014). Predictors of health status and health-related quality of life 12 months after severe burn. Burns, 40(4), 568-574;

81 FR 43048 (2016).

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.

Listing paragraph
Introductory Text prior to the effective date of this Final Rule
Revised Introductory Text with updated cross-references

6.00C7

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.) The formula for calculating BMI is in section 5.00G.

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).

14.00F5

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 5.00G2.

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).

100.00C2c
BMI is the ratio of a child's weight to the square of his or her height. We calculate BMI using the formulas in 105.00G2c.
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).

103.00K2c
BMI is the ratio of a child's weight to the square of his or her height. We calculate BMI using the formulas in 105.00G2c.
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).

104.00C3b(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 105.00G2c.
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).

106.00C5b(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 105.00G2c.
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).

114.00F7b(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 105.00G2c.
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).

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

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
Londoño, M.-C., Cárdenas, A., Guevara, M., Quintó, L., de las Heras, D., Navasa, M., Rimola, A., Garcia-Valdecasas, J.-C., Arroya, V., & Ginès, 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 * log
e
(bilirubin)) + (1.120 * log
e
(INR
21
)) + (0.957 * log
e
(creatinine)) + 0.643] * 10

(3.78 * log
e
(bilirubin)) + (11.20 * log
e
(INR)) + (9.57 * log
e
(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)−[0.033*MELD(i) * (137-Na)]
SSA CLD(i) + 1.32 * (137-Na)−[0.033*SSA CLD(i) * (137-Na)].

We modified the SSA CLD formula rather than directly adopting the MELD formula for multiple reasons. First, we use the SSA CLD score for different purposes than the medical community uses the MELD score. Specifically, MELD scores are used to determine a person's placement on the liver transplant list, while SSA CLD scores are used to determine whether a person's chronic liver disease is severe enough to preclude the performance of any gainful activity. While our analysis shows that the new SSA CLD calculation, which is mathematically equivalent to the current MELD calculation, is appropriate for our programmatic use, going forward, our analysis and research may determine that a SSA CLD calculation which differs from the MELD calculation is more appropriate for a determination of listing-level chronic liver disease. Likewise, the MELD calculation may change in a way that precludes us from using it to determine listing-level chronic liver disease. Because the MELD is maintained by an independent entity, we may not know of the change until it is in effect, and therefore would be tied to using an inappropriate formula until we were able to publish a regulatory change. In such instances, it is important that we retain flexibility and use our own calculation, rather than adopt the MELD formula, as the commenter suggests.

Moreover, the SSA CLD has unique testing standards that are consistent with our programmatic requirements. For instance, for the SSA CLD, we require that all laboratory values be obtained within a continuous 30-day period, and we do not use any INR values derived from testing done while the claimant is on anticoagulant treatment. These requirements are not in place for the MELD calculation (see 5.00C3 (
SSA Chronic Liver Disease (SSA CLD) score
) and 105.00C3a (
SSA CLD score
)). Finally, the SSA CLD score is familiar to our adjudicators because we began using it in 2007.

The commenter also misunderstands our use of SSA CLD scores. Because SSA CLD scores result from our regulatory formula, they are generally not available in the medical record, nor do we expect them to be. Instead, adjudicators must calculate the SSA CLD score using a formula that includes up to four laboratory values. The calculation is set forth in our regulations at 5.00C3 (
SSA Chronic Liver Disease (SSA CLD) score
) and 105.00C3a (
SSA CLD score
). Regardless of the formula used, we require the component values be present in the medical evidence of record, and then our adjudicators input those values into a calculator to determine the score based on the regulatory formula.

With regard to our changes to the SSA CLD formula, we describe the modified SSA CLD calculation in the introductory text in this final rule in paragraphs 5.00C3 (
SSA Chronic Liver Disease (SSA CLD) score
) and 105.00C3a (
SSA CLD score
). We reorganized the order of paragraphs 5.00C3b (“For any SSA CLD calculation”) and 5.00C3c (“When we indicate `log
e
' ”) and 105.00C3a(ii) (“For any SSA CLD calculation”) and 105.00C3a(iii) (“When we indicate `log
e
' ”) for clarity. We updated the instructions for rounding and limits for maximum and minimum values in paragraphs 5.00C3b and 105.00C3a(ii) (“For any SSA CLD calculation”) to reflect the addition of serum sodium to the CLD formula. Finally, we updated the CLD calculation examples in paragraphs 5.00C3c and 105.00C3a(iii) (“When we indicate `log
e
' ”) 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

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

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 P
a
O
2
measured by an ABG test”), one commenter asked us to either use both P
a
O
2
and P
a
CO
2
values, or the highest favorable P
a
O
2
for each altitude range, as noted in tables for P
a
O
2
/P
a
CO
2
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 P
a
O
2,
not P
a
CO
2
, 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
Rodríguez-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 P
a
O
2
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

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. & Argáez, 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

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., Peláez, R.B., Cuerda, C., Forbes, A., Gabe, S., Gillanders, L., Holst, M., Jeppesen, P.B., Joly, F., Kelly, D., Klek, S., Irtun, Ø., 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
).

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

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

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

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.

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

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

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 n

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2023-11771. Public record. Not legal advice.