Revised Medical Criteria for Evaluating Digestive Disorders and Skin Disorders, 37704-37747 [2023-11771]

Download as PDF 37704 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations 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 Social Security Administration. Final rule. AGENCY: ACTION: 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 https:// www.socialsecurity.gov. SUPPLEMENTARY INFORMATION: SUMMARY: 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. 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 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 https://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. Sections of the Adult Introductory Text and Listings for the digestive system prior to the effective date of this Final Rule 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 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: 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? ...................... B. What documentation do we need? ....................................................................... C. How do we consider the effects of treatment? .................................................... D. How do we evaluate chronic liver disease? ......................................................... E. How do we evaluate inflammatory bowel disease (IBD)? .................................... ddrumheller on DSK120RN23PROD with RULES2 F. How do we evaluate short bowel syndrome (SBS)? ............................................ G. How do we evaluate weight loss due to any digestive disorder? ........................ [5.00 D.12.] ................................................................................................................ H. What do we mean by the phrase ‘‘consider under a disability for 1 year’’? ........ [5.00 C.6.] .................................................................................................................. I. How do we evaluate impairments that do not meet one of the digestive disorder listings? 1 20 CFR 404.1525(a) and 416.925(a). CFR 416.925(a). 3 20 CFR 404.1520, 416.920, and 416.924. 4 72 FR 59398 (2007) and 69 FR 32260 (2004). 5 72 FR 70527 (2007). 2 20 VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 A. Which digestive disorders do we evaluate in this body system? B. What evidence do we need to evaluate your digestive disorder? [5.00 H.] C. What is chronic liver disease (CLD), and how do we evaluate it under 5.05? D. What is inflammatory bowel disease (IBD), and how do we evaluate it under 5.06? E. What is intestinal failure and how do we evaluate it under 5.07? F. How do we evaluate weight loss due to any digestive disorder under 5.08? G. How do we evaluate digestive organ transplantation? [5.00 C.2. and G.] 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? J. How do we evaluate digestive disorders that do not meet one of these listings? 6 74 FR 57972 (2009), with the docket number corrected at 74 FR 62518 (2009). 7 84 FR 35936 (2019). 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 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 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. E:\FR\FM\08JNR2.SGM 08JNR2 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations Sections of the Adult Introductory Text and Listings for the digestive system prior to the effective date of this Final Rule 37705 Revised sections of the Adult Introductory Text and Listings for digestive disorders Listings 5.01 5.02 Category of Impairments, Digestive System .................................................. Gastrointestinal hemorrhaging from any cause, requiring blood transfusion 5.03 5.04 5.05 5.06 5.07 5.08 5.09 [Reserved] ....................................................................................................... [Reserved] ....................................................................................................... Chronic liver disease (CLD) ............................................................................ Inflammatory bowel disease (IBD) .................................................................. Short bowel syndrome (SBS) ......................................................................... Weight loss due to any digestive disorder ..................................................... Liver transplantation ........................................................................................ The following table summarizes the current and revised sections of the 5.01 Category of Impairments, Digestive Disorders 5.02 Gastrointestinal hemorrhaging from any cause, requiring three blood transfusions 5.03 [Reserved] 5.04 [Reserved] 5.05 Chronic liver disease (CLD) 5.06 Inflammatory bowel disease (IBD) 5.07 Intestinal failure 5.08 Weight loss due to any digestive disorder 5.09 Liver transplantation 5.10 [Reserved] 5.11 Small intestine transplantation 5.12 Pancreas transplantation 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? ...................... B. What documentation do we need? ....................................................................... C. How do we consider the effects of treatment? .................................................... D. How do we evaluate chronic liver disease? ......................................................... E. How do we evaluate inflammatory bowel disease (IBD)? .................................... F. How do we evaluate short bowel syndrome (SBS)? ............................................ G. How do we evaluate growth failure due to any digestive disorder? .................... [105.00 D.13.] ............................................................................................................ H. How do we evaluate the need for supplemental daily enteral feeding via a gastrostomy? 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.6.] .............................................................................................................. K. How do we evaluate impairments that do not meet one of the digestive disorder listings? A. Which digestive disorders do we evaluate in this body system? B. What evidence do we need to evaluate your digestive disorder? [105.00 J.] C. What is chronic liver disease (CLD), and how do we evaluate it under 105.05? D. What is inflammatory bowel disease (IBD), and how do we evaluate it under 105.06? E. What is intestinal failure, and how do we evaluate it under 105.07? F. How do we evaluate growth failure due to any digestive disorder under 105.08? G. How do we evaluate digestive organ transplantation? 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? [105.00 C.2., C.4., and G.] 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? L. How do we evaluate digestive disorders that do not meet one of these listings? Listings 105.01 Category of Impairments, Digestive System .............................................. 105.02 Gastrointestinal hemorrhaging from any cause, requiring blood transfusion. 105.03 [Reserved] ................................................................................................... 105.04 [Reserved] ................................................................................................... 105.05 Chronic liver disease .................................................................................. 105.06 Inflammatory bowel disease (IBD) .............................................................. 105.07 Short bowel syndrome (SBS) ..................................................................... 105.08 Growth failure due to any digestive disorder .............................................. 105.09 Liver transplantation .................................................................................... 105.10 Need for supplemental daily enteral feeding via a gastrostomy ................ ddrumheller on DSK120RN23PROD with RULES2 The following table shows our changes to the adult and childhood digestive disorders listings criteria that involve changes to healthcare utilization VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 105.01 Category of Impairments, Digestive Disorders 105.02 Gastrointestinal hemorrhaging from any cause, requiring three blood transfusions 105.03 [Reserved] 105.04 [Reserved] 105.05 Chronic liver disease (CLD) 105.06 Inflammatory bowel disease (IBD) 105.07 Intestinal failure 105.08 Growth failure due to any digestive disorder 105.09 Liver transplantation 105.10 Need for supplemental daily enteral feeding via a gastrostomy, duodenostomy, or jejunostomy 105.11 Small intestine transplantation 105.12 Pancreas transplantation and condition/episode requirements, the rationale for each change, and supporting resources. The table first summarizes the policy changes that PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 apply to multiple adult and childhood digestive disorders listings and then focuses on changes in specific listings. E:\FR\FM\08JNR2.SGM 08JNR2 37706 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations 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. 5.05B/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: 5.02/105.02 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. ddrumheller on DSK120RN23PROD with RULES2 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 6month period; 3. One of the following occurring on at least two evaluations at least 60 days apart within the same consecutive 6month period as in F1: 5.05G/105.05G End stage liver disease with SSA CLD scores of 22 or greater calculated as described in 5.00D11. 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: 5.08 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 6month period. VerDate Sep<11>2014 18:50 Jun 07, 2023 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 (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 12month period as in F: 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) (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 (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. Jkt 259001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 E:\FR\FM\08JNR2.SGM 08JNR2 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations 37707 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 MELDbased survival prediction in alcoholic hepatitis. Mayo Clinic Proceedings, 86(1), 37–42. London˜o, M.-C., Ca´rdenas, A., Guevara, M., Quinto´, L., de las Heras, D., Navasa, M., Rimola, A., Garcia-Valdecasas, J.-C., Arroya, V., & Gine`s, P. (2007). MELD score and serum sodium in the prediction of survival of patients with cirrhosis awaiting liver transplantation. Gut, 56(9), 1283–1290. https://doi.org/ 10.1136/gut.2006.102764. Listing 5.05/105.05 ddrumheller on DSK120RN23PROD with RULES2 5.05G/105.05G End stage liver disease with SSA CLD scores of 22 or greater calculated as described in 5.00D11. VerDate Sep<11>2014 18:50 Jun 07, 2023 Chronic Liver Disease (CLD) 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. Jkt 259001 PO 00000 Frm 00005 Fmt 4701 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). Sfmt 4700 E:\FR\FM\08JNR2.SGM 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. 08JNR2 37708 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations ADULT AND CHILDHOOD DIGESTIVE DISORDERS LISTINGS CRITERIA—CHANGES IN HEALTHCARE UTILIZATION INTRODUCTORY TEXT—5.00/105.00—Continued Introductory Text or Listing Criteria Prior to the Effective Date of This Final Rule Revised Introductory Text or Listing Criteria ddrumheller on DSK120RN23PROD with RULES2 Listing 5.06/105.06 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 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. 18:50 Jun 07, 2023 Jkt 259001 PO 00000 Frm 00006 Resources 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 6month 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 VerDate Sep<11>2014 Rationale Fmt 4701 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. 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. Sfmt 4700 E:\FR\FM\08JNR2.SGM 20 CFR 404.1530 and 416.930. Need to follow prescribed treatment. SSR 18–3p: Titles II and XVI: Failure to Follow Prescribed Treatment. Public comment: https:// www.regulations.gov/comment/SSA2017-0042-0008. 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. & Arga´ez, C. (2018). Gastrostomy versus gastrojejunostomy and/ or jejunostomy feeding tubes: a review of clinical effectiveness, cost-effectiveness and guidelines. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health. Clinical Nutrition University. (2021, May 25). Types of Feeding Tubes EXPLAINED. YouTube. https:// www.youtube.com/watch?v=4Oam 1yUHiO8. 08JNR2 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations 37709 ADULT AND CHILDHOOD DIGESTIVE DISORDERS LISTINGS CRITERIA—CHANGES IN HEALTHCARE UTILIZATION INTRODUCTORY TEXT—5.00/105.00—Continued Introductory Text or Listing Criteria Prior to the Effective Date of This Final Rule No current listing criteria Revised Introductory Text or Listing Criteria Rationale Resources 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 (Sjo¨gren’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. Diseasea-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 ddrumheller on DSK120RN23PROD with RULES2 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). VerDate Sep<11>2014 18:50 Jun 07, 2023 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. Jkt 259001 PO 00000 Frm 00007 Fmt 4701 Intestinal Failure 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). Sfmt 4700 E:\FR\FM\08JNR2.SGM Public comment: https:// www.regulations.gov/comment/SSA2017-0042-0015. 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., Pela´ez, R.B., Cuerda, C., Forbes, A., Gabe, S., Gillanders, L., Holst, M., Jeppesen, P.B., Joly, F., Kelly, D., Klek, S., Irtun, ;., 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. 08JNR2 37710 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations ADULT AND CHILDHOOD DIGESTIVE DISORDERS LISTINGS CRITERIA—CHANGES IN HEALTHCARE UTILIZATION INTRODUCTORY TEXT—5.00/105.00—Continued Introductory Text or Listing Criteria Prior to the Effective Date of This Final Rule Revised Introductory Text or Listing Criteria Rationale Resources 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.00000000 00000631. 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 105.10 105.10 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). Need for supplemental daily enteral feeding via a gastrostomy, duodenostomy, or jejunostomy 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). Skin Disorders 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. The following table summarizes the current and revised sections of the adult Sections of the Adult Introductory Text and listings for skin disorders prior to the effective date of this final rule Public comment: https:// www.regulations.gov/comment/SSA2017-0042-0008. skin disorders introductory text and listings. Revised sections of the Adult Introductory Text and Listings for Skin Disorders Introductory Text, 8.00 ddrumheller on DSK120RN23PROD with RULES2 A. What skin disorders do we evaluate with these listings? ..................................... B. What documentation do we need? ....................................................................... [8.00C] ....................................................................................................................... C. How do we assess the severity of your skin disorder(s)? ................................... [8.00B] ....................................................................................................................... D. How do we assess impairments that may affect the skin and other body systems? [8.00C] ....................................................................................................................... E. How do we evaluate genetic photosensitivity disorders? ..................................... F. How do we evaluate burns? ................................................................................. 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?. [8.00C] ....................................................................................................................... H. How do we assess your skin disorder(s) if your impairment does not meet the requirements of one of these listings? [8.00D] ....................................................................................................................... [8.00H] ....................................................................................................................... A. Which skin disorders do we evaluate under these listings? [8.00C] B. What are our definitions for the following terms used in this body system? [8.00D] C. What evidence do we need to evaluate your skin disorder? [8.00H] D. How do we evaluate the severity of skin disorders? E. How do we evaluate genetic photosensitivity disorders under 8.07? F. How do we evaluate burns under 8.08? [8.00D] G. How do we evaluate chronic conditions of the skin or mucous membranes under 8.09? [8.00I] H. How do we evaluate disorders in other body systems that affect the skin? I. How do we evaluate skin disorders that do not meet one of these listings? Listings 8.01 8.02 Category of Impairments, Skin Disorders ....................................................... Ichthyosis ........................................................................................................ 9 The childhood digestive disorders listing includes SSA CLD–P scores (see 105.00C3). We are VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 8.01 Category of Impairments, Skin Disorders 8.02 [Reserved] [Now evaluated in 8.09] not proposing changes to the SSA CLD–P formula. PO 00000 Frm 00008 Fmt 4701 Sfmt 4700 This table discusses changes to the SSA CLD formula only. E:\FR\FM\08JNR2.SGM 08JNR2 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations Sections of the Adult Introductory Text and listings for skin disorders prior to the effective date of this final rule 8.03 Bullous disease ............................................................................................... 8.04 Chronic infections of the skin or mucous membranes ................................... 8.05 Dermatitis ........................................................................................................ 8.06 Hidradenitis suppurativa ................................................................................. 8.07 Genetic photosensitivity disorders .................................................................. 8.08 Burns ............................................................................................................... [8.02–8.06] ................................................................................................................. The following table summarizes the current and revised sections of the 37711 Revised sections of the Adult Introductory Text and Listings for Skin Disorders 8.03 8.04 8.05 8.06 8.07 8.08 8.09 [Reserved] [Now evaluated in 8.09] [Reserved] [Now evaluated in 8.09] [Reserved] [Now evaluated in 8.09] [Reserved] [Now evaluated in 8.09] Genetic photosensitivity disorders Burns Chronic conditions of the skin or mucous membranes 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? ..................................... B. What documentation do we need? ....................................................................... [108.00C] ................................................................................................................... C. How do we assess the severity of your skin disorder(s)? ................................... [108.00B] ................................................................................................................... D. How do we assess impairments that may affect the skin and other body systems?. [108.00C] ................................................................................................................... E. How do we evaluate genetic photosensitivity disorders? ..................................... F. How do we evaluate burns? ................................................................................. 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?. [108.00C] ................................................................................................................... H. How do we assess your skin disorder(s) if your impairment does not meet the requirements of one of these listings? [108.00D] ................................................................................................................... [108.00H] ................................................................................................................... A. Which skin disorders do we evaluate under these listings? [108.00C] B. What are our definitions for the following terms used in this body system? [108.00D] C. What evidence do we need to evaluate your skin disorder? [108.00H] D. How do we evaluate the severity of skin disorders? E. How do we evaluate genetic photosensitivity disorders under 108.07? F. How do we evaluate burns under 108.08? [108.00D] G. How do we evaluate chronic conditions of the skin or mucous membranes under 108.09? [108.00I] H. How do we evaluate disorders in other body systems that affect the skin? I. How do we evaluate skin disorders that do not meet one of these listings? Listings 108.01 Category of Impairments, Skin Disorders ................................................... 108.02 Ichthyosis .................................................................................................... 108.03 Bullous disease ........................................................................................... 108.04 Chronic infections of the skin or mucous membranes ............................... 108.05 Dermatitis .................................................................................................... 108.06 Hidradenitis suppurativa ............................................................................. 108.07 Genetic photosensitivity disorders .............................................................. 108.08 Burns ........................................................................................................... [108.02–108.06] ......................................................................................................... ddrumheller on DSK120RN23PROD with RULES2 The following table shows our changes to the adult and childhood skin disorders listings criteria that involve VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 108.01 108.02 108.03 108.04 108.05 108.06 108.07 108.08 108.09 Category of Impairments, Skin Disorders [Reserved] [Now evaluated in 108.09] [Reserved] [Now evaluated in 108.09] [Reserved] [Now evaluated in 108.09] [Reserved] [Now evaluated in 108.09] [Reserved] [Now evaluated in 108.09] Genetic photosensitivity disorders Burns Chronic conditions of the skin or mucous membranes changes to healthcare utilization and condition/episode requirements, the PO 00000 Frm 00009 Fmt 4701 Sfmt 4700 rationale for each change, and supporting resources. E:\FR\FM\08JNR2.SGM 08JNR2 37712 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations 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 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/s13555-0160130-9. 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. Introductory Text—8.00/108.00 ddrumheller on DSK120RN23PROD with RULES2 No current introductory text VerDate Sep<11>2014 18:50 Jun 07, 2023 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 Jkt 259001 PO 00000 Frm 00010 Fmt 4701 Sfmt 4700 E:\FR\FM\08JNR2.SGM 08JNR2 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations 37713 ADULT AND CHILDHOOD SKIN DISORDERS LISTINGS CRITERIA—CHANGES IN HEALTHCARE UTILIZATION AND CONDITION/ EPISODE REQUIREMENTS—Continued Introductory text or listing criteria prior to the effective date of this final rule Revised Introductory text or listing criteria 8.07/108.07 ddrumheller on DSK120RN23PROD with RULES2 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) VerDate Sep<11>2014 18:50 Jun 07, 2023 PO 00000 Frm 00011 Resources Genetic photosensitivity disorders 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 ageappropriate 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 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). Jkt 259001 Rationale Fmt 4701 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 Sfmt 4700 E:\FR\FM\08JNR2.SGM 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). 08JNR2 37714 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations ADULT AND CHILDHOOD SKIN DISORDERS LISTINGS CRITERIA—CHANGES IN HEALTHCARE UTILIZATION AND CONDITION/ EPISODE REQUIREMENTS—Continued Introductory text or listing criteria prior to the effective date of this final rule Revised Introductory text or listing criteria Rationale Resources 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 8.08/108.08 ddrumheller on DSK120RN23PROD with RULES2 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) VerDate Sep<11>2014 18:50 Jun 07, 2023 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 Jkt 259001 PO 00000 Frm 00012 Fmt 4701 Burns Sfmt 4700 E:\FR\FM\08JNR2.SGM 08JNR2 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations 37715 ADULT AND CHILDHOOD SKIN DISORDERS LISTINGS CRITERIA—CHANGES IN HEALTHCARE UTILIZATION AND CONDITION/ EPISODE REQUIREMENTS—Continued Introductory text or listing criteria prior to the effective date of this final rule Revised Introductory text or listing criteria Listing 8.09/108.09 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. ddrumheller on DSK120RN23PROD with RULES2 Resources Chronic conditions of the skin or mucous membranes 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. The following table shows our changes to references to BMI in other body systems. Prior to the effective date Rationale 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. of this final rule, the formulas for calculating BMI are referenced as appearing in 5.00G and 105.00G2c in 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). various listings, and we are correcting these references to reflect the revised digestive disorders listings. 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). 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 VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 to be made that severe impairment will last for a continuous period of at least 12 months.’’ 44 FR at 18787. PO 00000 Frm 00013 Fmt 4701 Sfmt 4700 11 Id. 12 Id. E:\FR\FM\08JNR2.SGM 08JNR2 37716 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations Listing paragraph Introductory Text prior to the effective date of this Final Rule Revised Introductory Text with updated cross-references 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. 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. 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. 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. 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. 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. 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). 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). 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). 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). 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). 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. ddrumheller on DSK120RN23PROD with RULES2 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 DiseasePediatric (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 VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 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 12month 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 PO 00000 Frm 00014 Fmt 4701 Sfmt 4700 (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 E:\FR\FM\08JNR2.SGM 08JNR2 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations 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 • Burns: We removed the ‘‘thirddegree’’ 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 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. 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. MELD [0.378 * loge(bilirubin)) + (1.120 loge(creatinine)) + 0.643] * 10. 37717 SSA CLD * loge(INR 21)) + (0.957 * (3.78 * loge(bilirubin)) + (11.20 * loge(INR)) + (9.57 * loge(creatinine)) + 6.43. If resulting value (MELD(i)) or SSA CLD(i)) is 12 or greater, the serum sodium value is considered in the following way: MELD(i) + 1.32 * (137–Na)¥[0.033*MELD(i) * (137–Na)] ...................... ddrumheller on DSK120RN23PROD with RULES2 13 20 CFR 404.1502(d) and 416.902(i). 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, 14 72 VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 SSA CLD(i) + 1.32 * (137–Na)¥[0.033*SSA CLD(i) * (137–Na)]. 2016, adding serum sodium to MELD calculation. https://unos.org/news/policy-and-system-changeseffective-january-11-2016-adding-serum-sodium-tomeld-calculation/. 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. PO 00000 Frm 00015 Fmt 4701 Sfmt 4700 20 London ˜ o, M.-C., Ca´rdenas, A., Guevara, M., Quinto´, L., de las Heras, D., Navasa, M., Rimola, A., Garcia-Valdecasas, J.-C., Arroya, V., & Gine`s, P. (2007). MELD score and serum sodium in the prediction of survival of patients with cirrhosis awaiting liver transplantation. Gut, 56(9), 1283– 1290. https://doi.org/10.1136/gut.2006.102764. 21 International Normalized Ratio (INR) is a common laboratory test that measures the amount of time it takes for the blood to clot. E:\FR\FM\08JNR2.SGM 08JNR2 ddrumheller on DSK120RN23PROD with RULES2 37718 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations 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 VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 those values into a calculator to determine the score based on the regulatory formula. With regard to our changes to the SSA CLD formula, we describe the modified SSA CLD calculation in the introductory text in this final rule in paragraphs 5.00C3 (SSA Chronic Liver Disease (SSA CLD) score) and 105.00C3a (SSA CLD score). We reorganized the order of paragraphs 5.00C3b (‘‘For any SSA CLD calculation’’) and 5.00C3c (‘‘When we indicate ‘loge’ ’’) and 105.00C3a(ii) (‘‘For any SSA CLD calculation’’) and 105.00C3a(iii) (‘‘When we indicate ‘loge’ ’’) for clarity. We updated the instructions for rounding and limits for maximum and minimum values in paragraphs 5.00C3b and 105.00C3a(ii) (‘‘For any SSA CLD calculation’’) to reflect the addition of serum sodium to the CLD formula. Finally, we updated the CLD calculation examples in paragraphs 5.00C3c and 105.00C3a(iii) (‘‘When we indicate ‘loge’ ’’) to reflect the change in the formula. Comment: One commenter stated that we do not provide evidence that SSA CLD scores greater than or equal to 20 are a measure of the ability or inability to engage in substantial gainful activity (SGA). Response: We disagree. The rule change reflects medical research showing the increased 3-month mortality risk and overall clinical severity indicated by laboratory values resulting in an SSA CLD score of at least 20.22 23 24 For instance, individuals with a MELD score ranging from 10–19 have a 3-month mortality rate of 6%, whereas individuals with a MELD score between 20 and 29 have a 3-month mortality rate of 19.6%, which means they are more than three times more likely to die within 3 months if they do not receive a transplant.25 As explained above, the MELD score is equivalent to the SSA CLD score. This degree of severity is consistent with liver disease that will prevent an adult from engaging in any gainful activity, result in death, or cause marked and severe limitations in children over the age of 12. Clinical 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/evaluationprognosis-cirrhosis/core-concept/all. 25 Id. PO 00000 Frm 00016 Fmt 4701 Sfmt 4700 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. 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. 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 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 26 72 FR 59398 (2007). 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. 28 20 CFR 404.1525(a) and 416.925(a). 29 20 CFR 416.925(a). 27 Chung-Chou, E:\FR\FM\08JNR2.SGM 08JNR2 ddrumheller on DSK120RN23PROD with RULES2 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations 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- VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 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 widelyaccepted 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 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. PO 00000 Frm 00017 Fmt 4701 Sfmt 4700 37719 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 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. 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 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. 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. E:\FR\FM\08JNR2.SGM 08JNR2 37720 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations insufficient, we may purchase the needed medical examinations or tests, but this is an individualized and factspecific 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 Comment: Commenters requested that we include a statement in listings 5.05E and 105.05E (‘‘Hepatopulmonary syndrome’’) that hypoxemia due to hepatopulmonary syndrome may also be evaluated under listing 3.02C2 (Chronic respiratory disorders) or the childhood respiratory listings. For proposed criterion in listing 5.05E1 (‘‘Arterial PaO2 measured by an ABG test’’), one commenter asked us to either use both PaO2 and PaCO2 values, or the highest favorable PaO2 for each altitude range, as noted in tables for PaO2/PaCO2 measurements in the respiratory listing for hypoxemia. Response: We did not adopt these comments. Hepatopulmonary syndrome is not the same as hypoxemia caused by a chronic respiratory disorder. Hepatopulmonary syndrome is not a respiratory disease. It is a rare complication of liver disease, characterized by arterial deoxygenation due to intrapulmonary vascular dilation and arteriovenous shunting.42 43 Hypoxemia is defined as a belownormal level of oxygen in the blood, specifically in the arteries.44 The only effective treatment for hepatopulmonary syndrome is liver transplant. Severity grading of hepatopulmonary syndrome is based on measurements of PaO2, not PaCO2, and 5.05E1 and 105.05E1 consider altitude when determining whether a claimant’s hepatopulmonary syndrome is listing-level severity.45 46 For these reasons, we are not including a syndrome caused by liver disease in 41 20 CFR 404.1519a and 416.919a. 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/pulmonarydisorders/pulmonary-hypertension/ hepatopulmonary-syndrome. 44 Taber’s Cyclopedic Medical Dictionary—23rd Ed. (2017). 45 Rodrı ´guez-Roisin, R., & Krowka, M.J. (1998). Hepatopulmonary syndrome—a liver-induced lung vascular disorder. The New England Journal of Medicine, 358, 2378–2387. https://doi.org/10.1056/ NEJMra0707185. 46 Grilo-Bensusan, I., & Pascasio-Acevedo, J.M. (2016). Hepatopulmonary syndrome: What we know and what we would like to know. World Journal of Gastroenterology, 22(25), 5728–5741. https://doi.org/10.3748/wjg.v22.i25.5728. ddrumheller on DSK120RN23PROD with RULES2 42 Taber’s VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 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 Comment: One commenter suggested we remove proposed criterion 5.05E2 (‘‘Intrapulmonary arteriovenous shunting’’) as it demonstrates only the presence of hepatopulmonary syndrome and not a level of hypoxemia or severity associated with proposed 5.05E1 (‘‘Arterial PaO2 measured by an ABG test’’). The commenter stated that it is not clear that arteriovenous shunting as shown by the contrasted echocardiogram or macroaggregated albumin lung scan required in proposed criterion 5.05E2 (‘‘Intrapulmonary arteriovenous shunting’’) necessarily equates to the expected severity associated with the required hypoxemia levels in proposed criterion 5.05E1 (‘‘Arterial PaO2 measured by an ABG test’’). The commenter noted that some of these tests in proposed 5.05E2 (‘‘Intrapulmonary arteriovenous shunting’’) are not quantitative, and not all of them are specific for intrapulmonary shunting. The commenter asked us to add these tests to the introductory text along with the symptoms of platypnea (shortness of breath relieved when lying down) and orthodeoxia (low arterial blood oxygen in the upright position) that are highly specific for hepatopulmonary syndrome when present alongside chronic liver disease. Response: We partially adopted the comment. We updated the introductory text at 5.00C2e and 105.00C2e (Hepatopulmonary syndrome) to include the clinical findings suggested by the commenter. While we agree with the commenter that the criteria in 5.05E2 and 105.05E2 demonstrate the presence of hepatopulmonary syndrome and not a level of hypoxemia, we kept the criterion because the presence of hepatopulmonary syndrome, as confirmed by these tests, continues to be indicative of listing-level severity. Hepatopulmonary syndrome is a very serious consequence of chronic liver 47 20 PO 00000 CFR 404.1526 and 416.926. Frm 00018 Fmt 4701 Sfmt 4700 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 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. 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 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. 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. E:\FR\FM\08JNR2.SGM 08JNR2 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations 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 12month 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?). ddrumheller on DSK120RN23PROD with RULES2 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 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. & Arga ´ ez, C. (2018). Gastrostomy versus gastrojejunostomy and/or jejunostomy feeding tubes: a review of clinical effectiveness, cost-effectiveness and guidelines. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health. 53 Clinical Nutrition University. (2021, May 25). Types of Feeding Tubes EXPLAINED. YouTube. https://www.youtube.com/watch?v=4Oam1yUHiO8. VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 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. 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 listinglevel 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 54 20 CFR 404.1525(a) and 416.925(a). 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. 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). 55 Nightingale, PO 00000 Frm 00019 Fmt 4701 Sfmt 4700 37721 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 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 59 20 60 20 E:\FR\FM\08JNR2.SGM CFR 404.1520 and 416.920. CFR 416.924. 08JNR2 37722 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations 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?). ddrumheller on DSK120RN23PROD with RULES2 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 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., Pela´ez, R.B., Cuerda, C., Forbes, A., Gabe, S., Gillanders, L., Holst, M., Jeppesen, P.B., Joly, F., Kelly, D., Klek, S., Irtun, ;., 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 metaregression. The American journal of clinical nutrition, 110(2), 430–436. https://doi.org/10.1093/ ajcn/nqz110. VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 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). Likewise, consistent with the comments supporting the change from 6 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/anemiayg.pdf. PO 00000 Frm 00020 Fmt 4701 Sfmt 4700 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 12month 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 12month 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 E:\FR\FM\08JNR2.SGM 08JNR2 ddrumheller on DSK120RN23PROD with RULES2 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations 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 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 70 Center for Disease Control. https:// www.cdc.gov/healthyweight/assessing/bmi/adult_ bmi/. The CDC does not alter BMI calculations for adults 20 years and older. 71 20 CFR 404.1520 and 416.920. VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 digestive disorders. For example, while increased malnutrition risk is associated with IBD, it is not thought to cause IBD.72 73 Growth Failure Comment: One commenter suggested that we define growth failure as weightfor-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 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. 74 42 FR 14705, 14710 (1977). 75 66 FR 57009, 57014 (2001). 76 66 FR at 57021 (2001). PO 00000 Frm 00021 Fmt 4701 Sfmt 4700 37723 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. 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. 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. E:\FR\FM\08JNR2.SGM 08JNR2 37724 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations ddrumheller on DSK120RN23PROD with RULES2 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 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 posttransplant 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 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/livertransplant/about/pac-20384842. 86 See 5.00G and 105.00G (How do we evaluate digestive organ transplantation?). VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 medical record at the time of reevaluation.87 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. 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 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 CFR 404.1589 and 416.989. 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. 90 20 CFR 404.1520 and 416.920. 91 20 CFR 416.924. 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. 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 87 20 88 Yi, PO 00000 Frm 00022 Fmt 4701 Sfmt 4700 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/SSR2018-03di-02.html. E:\FR\FM\08JNR2.SGM 08JNR2 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations 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 ddrumheller on DSK120RN23PROD with RULES2 Skin Disorders Comment: Several commenters asked that we add wheeled mobility devices, specifically wheelchairs, adaptive or special needs strollers, and scooters, to our definition of ‘‘assistive device(s)’’ in 8.00B1 and 108.00B1 (Assistive device(s)).97 The commenters also noted that while the wheeled mobility devices they requested are not hand-held or worn, they improve stability and mobility, and stated claimants with a documented medical need for these devices have functional limitations at least as significant to those with a need for other assistive devices. Response: We generally adopted these comments, specifying alternative examples. We incorporated devices used in a seated position into the definition of assistive device(s) in 8.00B1 and 108.00B1 (Assistive device(s)). Rather than using the suggested examples of ‘‘wheelchairs, adaptive or special needs strollers, and scooters,’’ we used examples such as wheelchair, rollator, and power operated vehicle. We chose these examples because the National Academies of Sciences, Engineering, 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. 97 We note that the commenters referenced 8.00B2 and 108.00B2 (Chronic skin lesions), which is not correct. The correct reference for the definition of ‘‘assistive device(s)’’ for this comment is 8.00B1 and 108.00B1 (Assistive device(s)). VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 and Medicine described these types of wheeled and seated mobility devices in a consensus study report on assistive technology.98 This change is also consistent with the definition of ‘‘assistive device(s)’’ used in the recently published final rule, Revised Medical Criteria for Evaluating Musculoskeletal Disorders.99 Comment: Several commenters stated that the definition of ‘‘fine and gross movements’’ in 8.00B5 and 108.00B5 (Fine and gross movements) should include ‘‘feeling’’ as a fine movement, in keeping with SSR 85–15 (Titles II and XVI: Capability to Do Other Work—The Medical-Vocational Rules as a Framework for Evaluating Solely Nonexertional Impairments.) 100 In addition, a commenter also referenced SSR 09–6p (Title XVI: Determining Childhood Disability—The Functional Equivalence Domain of ‘‘Moving About and Manipulating Objects.’’) 101 Response: We disagree with the comments and did not adopt the suggestion. SSR 85–15 (Titles II and XVI: Capability to Do Other Work—The Medical-Vocational Rules as a Framework for Evaluating Solely Nonexertional Impairments) provides guidance to our adjudicators on the capability to do other work, applicable at step 5 of the sequential evaluation process; it is therefore not within the scope of this final rule, which addresses the listings step of the sequential evaluation process. With regard to SSR 09–6p (Title XVI: Determining Childhood Disability—The Functional Equivalence Domain of ‘‘Moving About and Manipulating Objects’’), this SSR is consolidated guidance for our adjudicators for evaluating the functional equivalence domain of moving about and manipulating objects for children, which is also not within the scope of this final rule. While these SSRs are not within the scope of this final rule, we note that SSR 09–6p (Title XVI: Determining Childhood Disability—The Functional Equivalence Domain of ‘‘Moving About and Manipulating Objects’’) does not specifically mention feeling in regard to fine and gross movements, only that sensory loss that interferes with motor activities is a limitation we consider 98 National Academies of Sciences, Engineering, and Medicine. (2017). The promise of assistive technology to enhance activity and work participation. The National Academies Press. https://doi.org/10.17226/24740. 99 85 FR 78164 (2020). 100 SSR 85–15 (1985). Available at: https:// www.ssa.gov/OP_Home/rulings/di/02/SSR85-15-di02.html. 101 SSR 09–6p (2009). Available at: https:// www.ssa.gov/OP_Home/rulings/ssi/02/SSR2009-06ssi-02.html. PO 00000 Frm 00023 Fmt 4701 Sfmt 4700 37725 under the domain of ‘‘moving about and manipulating objects.’’ Moreover, SSR 85–15 (Titles II and XVI: Capability to Do Other Work—The MedicalVocational Rules as a Framework for Evaluating Solely Nonexertional Impairments) discusses ‘‘feeling’’ as a manipulative impairment, not as a fine movement as the commenter implies. However, if the claimant’s skin condition causes limitations in their ability to feel, which also results in significant deficits in their ability to perform fine and gross movements as defined in 8.00B5 and 108.00B5 (Fine and gross movements), their skin condition may be found to meet the listing criteria. If the evidence does not support a finding that the claimant’s skin condition meets a listing, any additional impact of the claimant’s loss of ability to feel due to a skin condition would be evaluated under our medical equivalence rules (as well as our functional equivalence rules for child claimants) at step 3 of the sequential evaluation, or at steps 4 and 5 of the sequential evaluation process for adult claimants.102 Comment: Several commenters stated that it was unclear why proposed sections 8.00C3d and 108.00C3d (What evidence do we need to evaluate your skin disorder?) require information about the claimant’s ‘‘history of familial incidence’’ of a skin impairment.103 They asserted that the information may be unobtainable (for example, family members may be absent, deceased, not receiving medical treatment, or reluctant to share medical information), and the history does not affect the claimant’s level of functioning. Response: Our changes only reorganized the current guidance into an outline format for easier reading; we did not propose new requirements. Additionally, our guidance in 8.00B and 108.08B (What documentation do we need?) applies to the entirety of the skin listings, and as we state in 8.00A and 108.00A (Which skin disorders do we evaluate under these listings?) of the current rules, we evaluate skin disorders that result from hereditary, congenital, or acquired pathological processes. Therefore, a history of familial incidence, when available, may help us in evaluating hereditary skin disorders. For example, for many inherited skin disorders, we consider a family history as key information in helping establish a medically determinable 102 20 103 84 E:\FR\FM\08JNR2.SGM CFR 404.1545(d) and 416.945(d). FR at 35948, 35956 (2019). 08JNR2 37726 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations ddrumheller on DSK120RN23PROD with RULES2 impairment.104 Additionally, other conditions, such as atopic dermatitis, have a high familial occurrence, and therefore a family history is useful information in establishing the presence of a medically determinable impairment.105 However, for other skin conditions, including acquired conditions such as burn injuries, a familial history is less relevant, and we would not seek information on familial incidence in those cases. Nevertheless, we made minor changes in response to this comment, and acknowledge some claimants will not have a history of familial incidence or access to adequate or any health information about genetic relatives. While familial incidence is useful, we will use other available information and medical evidence to establish the medically determinable impairment in instances where it is not available. We modified 8.00C3 and 108.00C3 (What evidence do we need to evaluate your skin disorder?) and its subparagraphs. In this final rule, we split the requirements from proposed 8.00C3d and 108.00C3d (‘‘Your history of familial incidence; exposure to toxins, allergens or irritants; seasonal variations; and stress factors’’) into two paragraphs, and we revised our wording about history of familial incidence to ‘‘Any available history of familial incidence’’ in final 8.00C3d and 108.00C3d (‘‘Any available history of familial incidence’’). We inserted ‘‘Your exposure to toxins, allergens, or irritants; seasonal variations; and stress factors’’ into final 8.00C3e (‘‘Your exposure to toxins, allergens or irritants; seasonal variations; and stress factors’’) and 108.00C3e (‘‘Your exposure to toxins, allergens or irritants; seasonal variations; and stress factors’’). We relettered subparagraphs 8.00C3e and 108.00C3e (‘‘Your ability to function outside of a highly protective environment’’) through 8.00C3h and 108.00C3h (‘‘Statements you or others make about your disorder(s), your restrictions, and your daily activities’’) to 8.00C3f through 8.00C3i and 108.00C3f through 108.00C3i, respectively. Comment: Several commenters asked that we omit the word ‘‘prescribed’’ from 8.00D (How do we evaluate the severity of skin disorders?) because 104 Tantcheva-Poor, I., Oji, V., & Has, C. (2016) A multistep approach to the diagnosis of rare genodermatoses. Journal of the German Society of Dermatology, 14(10), 969–986. https://doi.org/ 10.1111/ddg.13140. 105 DeStefano, G.M., & Christiano, A.M. (2014) The genetics of human skin disease. Cold Spring Harbor Perspectives in Medicine, 4(10), a015172. https://doi.org/10.1101/cshperspect.a015172. VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 some medically necessary treatments recommended by medical providers for skin conditions (for example, medicated baths, frequent bandage changes, or over-the-counter ointments) do not require a prescription. The commenters believe that this change would better align with the statement in 8.00B4 (Documented medical need) that assistive devices do not need to be prescribed in order to be considered by adjudicators. Response: We have partially accepted this comment. As the commenters note, and as is consistent with our other regulations, medical providers other than physicians may ‘‘prescribe’’ or recommend treatment. To acknowledge this, we are changing the term ‘‘physician’’ in 8.00D5b and 108.00d5b (Despite adherence to prescribed medical treatment for 3 months) to ‘‘medical source’’ to account for the types of treatments identified by the commenters above.106 As defined in our regulations, a ‘‘medical source’’ means an individual who is licensed as a healthcare worker by a State and working within the scope of practice permitted under State or Federal law, or an individual who is certified by a State as a speech-language pathologist or a school psychologist and acting within the scope of practice permitted under State or Federal law.107 Prescribed medical treatment means that a medical source has instructed the patient to adhere to a specified treatment, such as any medication, surgery, therapy, the use of durable medical equipment, or the use of assistive devices. Prescribed treatment does not include lifestyle modifications, such as dieting, exercise, or smoking cessation. We will consider any evidence of prescribed treatment, whether it appears on prescription forms or is otherwise indicated within a medical source’s records. An assistive device(s), as explained in 8.00B and 108.00B (What are our definitions for the following terms used in this body system?) of this final rule, is not a treatment method for a skin disorder. An assistive device(s) is any device used to improve stability, dexterity, or mobility, and does not need to be prescribed for adjudicators to consider its use as long as there is a documented medical need for the assistive device. Comment: A few commenters stated that proposed 8.00D6b (‘‘If, for any reason, you have not received treatment’’) 108 is contrary to the ‘‘spirit’’ 106 20 CFR 404.1502(d) and 416.902(i). 107 Id. 108 Paragraph 8.00D6b (‘‘If, for any reason, you have not received treatment’’) of the proposed and final rule states in part, ‘‘If, for any reason, you have PO 00000 Frm 00024 Fmt 4701 Sfmt 4700 of SSR 18–3p (Titles II and XVI: Failure to Follow Prescribed Treatment).109 The commenters added that SSR 18–3p provides ‘‘several reasons (including religion, inability to pay, incapacity, intense fear of surgery, risk of opioid addiction, etc.) why noncompliance with prescribed medicine could be excused.’’ The commenters state that the same exceptions for excusing medical treatment compliance might be the same reasons why a person has not received treatment. The commenters recommended that if we do not remove proposed 8.00D6b (‘‘If, for any reason, you have not received treatment’’), we should state that the reasons from SSR 18–3p are reasons a skin disorder could meet listing 8.09 (Chronic conditions of the skin or mucous membranes) without evidence of treatment. Response: We did not adopt these comments. The commenters misunderstand our policy for failure to follow prescribed treatment in this instance. We only consider our failure to follow prescribed treatment policy and procedures after determining that a person is entitled to disability benefits. Once we determine that a person is entitled to disability benefits, we determine whether the evidence indicates that the person might not have been entitled to disability benefits if they had followed prescribed treatment. Therefore, in the case of listing 8.09 (Chronic conditions of the skin or mucous membranes), before we make a failure to follow prescribed treatment determination, we first need to determine that a person’s skin disorder meets all of our criteria for listing 8.09 (Chronic conditions of the skin or mucous membranes), including listing criteria related to treatment. In the introductory text at 8.00D5b (Despite adherence to prescribed medical treatment for 3 months) we state that under listing 8.09 (Chronic conditions of the skin or mucous membranes), we require that a person’s symptoms persist ‘‘despite adherence to prescribed treatment for 3 months.’’ The adherence to prescribed treatment is a part of the listing criteria and must be present in order for a person’s skin condition to meet the criteria of the listing. Therefore, it is not possible to find a person disabled under listing 8.09 (Chronic conditions of the skin or mucous membranes) without a record of prescribed treatment, which is further explained in paragraph 8.00D6b (‘‘If, for not received treatment, your skin disorder cannot meet the criteria for 8.09.’’ 109 83 FR 49616 (2018) and SSR 18–3p (2018). Available at: https://www.ssa.gov/OP_Home/ rulings/di/02/SSR2018-03-di-02.html. E:\FR\FM\08JNR2.SGM 08JNR2 ddrumheller on DSK120RN23PROD with RULES2 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations any reason, you have not received treatment’’). This is clarified by our guidance in SSR 18–3p (Titles II and XVI: Failure to Follow Prescribed Treatment), where we explain that a failure to follow prescribed treatment determination is not applicable when a listed impairment(s) requires us to consider whether a person was following a specific treatment as part of satisfying the listing analysis. Moreover, the requirement for prescribed treatment for skin disorders dates back to 1979.110 We last comprehensively revised the listings for evaluating skin disorders in 2004. In the preamble to that final rule, we explained that the original requirement for extensive lesions ‘‘not responding to prescribed treatment’’ was replaced with the more specific requirement that there be ‘‘extensive skin lesions that persist for at least 3 months despite continuing treatment as prescribed.’’ 111 We are retaining that requirement with this update; however, with this final rule, we are finalizing our proposal to change the language to ‘‘despite adherence to prescribed medical treatment’’ to be more consistent with current medical terminology. Additionally, we do not deny a claim if a person does not have an impairment that meets a listing. We may find the impairment(s) medically equals a listing (or, in the case of a child seeking Supplemental Security Income (SSI) payments, functionally equals the listings). If an adult claimant’s impairment(s) does not meet or medically equal any listing, we may find them disabled at a later step in the sequential evaluation process. A lack of treatment history, as a solitary factor, does not require us to deny a claim. We evaluate a claim, including all record evidence, regardless of whether a person has received treatment for their impairment(s). Comment: Several commenters asked us not to finalize the proposed changes to the functional criteria because the changes we propose to the skin disorders listings are ‘‘more onerous,’’ and they assert that fewer applicants will qualify for disability based on these updated criteria. These commenters believed the updates would prolong the process of applying for disability by necessitating assessment at later steps in the sequential evaluation process and would require vocational information and consideration of a person’s age, education, and work experience, to make a determination. The commenters also expressed concern that these 110 44 111 69 FR 18170, 18187 (1979). FR 32260, 32264 (2004). VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 updates will ultimately result in more denials of claims at the initial and reconsideration levels. For instance, the commenters suggested that a person’s skin disorder would be unable to meet a skin disorders listing if only one side of a groin and an axilla (underarm) was involved instead of both sides of the groin or the axillae (underarms). Response: We did not adopt these comments. The requirement that the claimant’s skin disorder results in significant functional limitations lasting a minimum of 12 months despite adherence to treatment dates back to 1979.112 The introductory text to our 1979 final rule stated that the claimant’s skin lesions ‘‘must be shown to have persisted for a sufficient period of time despite therapy for a reasonable presumption to be made that severe impairment will last for a continuous period of at least 12 months.’’ 113 This is a requirement in our current rule as well, which states that we require evidence that the claimant’s skin disorder results in a degree of functional limitation such that the claimant is ‘‘unable to do any gainful activity for a continuous period of at least 12 months’’ (see current 8.00C2 and 108.00C2 (Frequency of flare-ups)). The language in the final rule reflects a continuation of this requirement, stating that we must have medically documented evidence of physical limitation(s) of functioning related to the claimant’s skin disorder, and that the decrease in physical function resulting from the claimant’s skin disorder must have lasted, or can be expected to last, for a continuous period of at least 12 months (8.00D2 and 108.00D2 (Limitation(s) of physical functioning due to skin disorders). Further, this is consistent with our program-wide rules for the Listing of Impairments, which identify impairments that preclude the ability to perform any gainful activity (or, in the case of a child applying for SSI payments based on disability, which identify impairments that result in marked and severe functional limitations) and have lasted or can be expected to last for a continuous period of at least 12 months.114 Also consistent with our rules dating back to 1979, our current rule acknowledges that because skin disorders frequently respond to treatment, we must have evidence of treatment for a ‘‘sufficient time’’ before we can appropriately assess the impact 112 44 FR 18170, 18187 (1979), 45 FR 55566, 55607 (1980), and 50 FR 50068, 50098 (1985). 113 44 FR at 18787. 114 20 CFR 404.1525 and 416.925. PO 00000 Frm 00025 Fmt 4701 Sfmt 4700 37727 of the treatment and the resultant effects on the claimant’s functional capacity (see current 8.00C4 and 108.00C4 (Treatment)). For current adult listings 8.02 (Ichthyosis) through 8.06 (Hidradenitis suppurativa) and the equivalent current childhood listings 108.02 through 108.06, which have been consolidated into listings 8.09 and 108.09 (Chronic conditions of the skin or mucous membranes) in this final rule, the claimant must adhere to prescribed medical treatment for at least three months. The continued presence of the skin disorder despite adherence to prescribed medical treatment for at least three months allows the adjudicator to make a reasonable presumption that the skin disorder will meet the durational requirement for disability.115 However, medical evidence only showing the continued presence of a skin disorder despite adherence to prescribed treatment is insufficient to find that the claimant’s skin disorder meets the listing criteria. In order to find that the claimant’s skin impairment meets a listing, we must have evidence of listing-level functional limitation that has lasted, or can be expected to last, for a continuous period of at least 12 months. Addressing the commenters’ concern that our new functional criteria are more onerous, we specifically refer to certain areas of the body in the current and in this final rule. Generally, skin disorders that affect these areas, such as ichthyosis and bulbous diseases, result in functional limitations. This is not a change from our current criteria. In our current criteria at 8.00C1 and 108.00C1 (Extensive skin lesions), we define ‘‘extensive skin lesions,’’ which we require in current adult listings 8.02 (Ichthyosis) through 8.06 (Hidradenitis suppurativa) and current childhood listings 108.02 (Ichthyosis) through 108.06 (Hidradenitis suppurativa), 8.07B and 108.07B (‘‘Other genetic photosensitivity disorders’’), and 8.08 and 108.08 (Burns), as lesions that ‘‘involve multiple body sites or critical body areas, and result in a very serious limitation.’’ We provide examples of ‘‘extensive skin lesions,’’ to include conditions such as ‘‘skin lesions that interfere with the motion of your joints and that very seriously limit your use of more than one extremity,’’ ‘‘skin lesions on the palms of both hands that very seriously limit your ability to do fine and gross motor movements,’’ and ‘‘skin lesions on the soles of both feet, the perineum, or both inguinal areas that very seriously limit your ability to ambulate.’’ 115 20 E:\FR\FM\08JNR2.SGM CFR 404.1509 and 416.909. 08JNR2 ddrumheller on DSK120RN23PROD with RULES2 37728 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations The updated functional criteria for skin disorders reflect our continued focus on the functional limitations skin disorders may cause and reflect a level of functional limitation similar to the criteria in our current rules. In order to clarify that focus, we have moved from providing examples of listing-level limitations caused by skin disorders, as we do in the current introductory text, to the use of precise and functional criteria set forth in this final rule at 8.00D2 and 108.00D2 (Limitation(s) of physical functioning due to skin disorders). The articulation of these specific functional criteria prompts adjudicators to focus on the resultant functional limitations caused by the claimant’s skin impairment in a consistent manner across cases. In the proposed rule, and in this final rule, we specify that a medically determinable skin impairment will generally meet a listing when it has or can be expected to last for a continuous period of at least 12 months and is medically documented by one of the functional limitations in these listings. This means that the updated rule will not necessarily result in a denial. To use the example cited by the commenter, a person’s skin impairment resulting in lesions on an axilla and one side of the groin may still meet one of these listings, because there may be medical documentation that the chronic skin lesions or contractures result in limitations that satisfy at least one of the functional criteria provided. If an adult’s impairment(s) does not meet or medically equal any listing, we may find that person disabled at a later step in the sequential evaluation process.116 If a child’s impairment(s) does not meet or medically equal any listing, we may find that their impairment(s) functionally equal the listings.117 Comment: A few commenters asked us to remove the words ‘‘third-degree’’ from proposed 8.08 and 108.08 (Burns). The commenters stated that fourthdegree burns, which go beyond the skin and underlying tissue to muscles and bones, are at least as detrimental to functioning as third-degree burns, and that second-degree burns, especially, but not only in combination with higher-degree burns, can cause scarring that causes pain and limits function. Response: We adopted this comment and removed the qualifier ‘‘thirddegree’’ from listings 8.08 and 108.08 (Burns). The comment brought a perspective that we hadn’t considered. We adopted the comment and removed 116 20 117 20 CFR 404.1520 and 416.920. CFR 416.924. VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 the qualifier ‘‘third degree’’ from listing 8.08 and 108.08 because skin lesions and contractures that affect function, although often caused by third-degree burns, can also be caused by deep partial thickness (deep second degree) burns or fourth-degree burns.118 Additionally, the measurement of burn depth in the medical record is not always precise because many providers have difficulty accurately assessing burn depth, there is a need for development of adequate methods of precisely measuring burn depth, and burns often progress to a greater depth than initially documented.119 120 121 122 Comment: One commenter asked us to reorder the proposed listings in a more manageable and understandable fashion. Specifically, the commenter stated that by eliminating listings 8.02 (Ichthyosis) through 8.09 (Chronic conditions of the skin or mucous membranes) and 108.02 (Ichthyosis) through 108.09 (Chronic conditions of the skin or mucous membranes) we made these listings more complicated to read and administer. The commenter stated that for the relatively unusual skin conditions, cross-referencing and placing all of the examples of skin conditions in the current listings into proposed listings 8.09 and 108.09 (Chronic conditions of the skin or mucous membranes) made these listings confusing for adjudicators, advocates, and lay people. Response: We have partially adopted these comments. We did not adopt the commenter’s suggestion to reorder the skin disorders listings; contrary to the commenter’s assertion, we did not eliminate listings 8.09 and 108.09 (Chronic conditions of the skin and mucous membranes). These are new listings in the proposed rule. Similarly, 118 Jeschke, M.G., van Baar, M.E., Choudhry, M.A., Chung, K.K., Gibran, N.S., & Logsetty, S. (2020). Burn injury. Nature reviews. Disease primers, 6(1), 11. https://doi.org/10.1038/s41572020-0145-5. 119 Id. 120 Bettencourt, A.P., Romanowski, K.S., Joe, V., Jeng, J., Carter, J.E., Cartotto, R., Craig, C.K., Fabia, R., Vercruysse, G.A., Hickerson, W.L., Liu, Y., Ryan, C.M., & Schulz, J.T. (2020). Updating the Burn Center Referral Criteria: Results From the 2018 eDelphi Consensus Study. Journal of burn care & research: official publication of the American Burn Association, 41(5), 1052–1062. https://doi.org/ 10.1093/jbcr/iraa038. 121 Burgess, M., Valdera, F., Varon, D., Kankuri, E., & Nuutila, K. (2022). The Immune and Regenerative Response to Burn Injury. Cells, 11(19), 3073. https://doi.org/10.3390/cells11193073. 122 Markiewicz-Gospodarek, A., Kozio5, M., Tobiasz, M., Baj, J., Radzikowska-Bu¨chner, E., & Przekora, A. (2022). Burn Wound Healing: Clinical Complications, Medical Care, Treatment, and Dressing Types: The Current State of Knowledge for Clinical Practice. International journal of environmental research and public health, 19(3), 1338. https://doi.org/10.3390/ijerph19031338. PO 00000 Frm 00026 Fmt 4701 Sfmt 4700 we did not eliminate listings 8.02 (Ichthyosis) through 8.08 (Burns) and 108.02 (Ichthyosis) through 108.08 (Burns). Rather, we removed adult listings 8.02 (Ichthyosis) through 8.06 (Hidradenitis suppurativa) and childhood listings 108.02 (Ichthyosis) through 108.06 (Hidradenitis suppurativa), and consolidated their current repetitive criteria into one listing for chronic conditions of the skin or mucous membranes (revised 8.09 and 108.09 (Chronic conditions of the skin and mucous membranes)), regardless of whether the condition is commonly known or relatively rare, to strengthen adjudicative ease and more efficiently identify adults and children with skin disorders of listing-level severity. As we explained in the NPRM, the criteria in the current listings are identical for each type of skin disorder, and all of the named disorders are chronic conditions of the skin or mucous membranes.123 For instance, adjudicators will not need to search examples of skin conditions in various skin disorders listings to locate a person’s listed medically determinable skin impairment. If ‘‘relatively unusual skin conditions’’ are not in the listed examples of skin disorders, the adjudicator will no longer need to determine which listed impairment(s) is most comparable to a person’s medically determinable impairment of the skin or mucous membranes to proceed with evaluating the claim. As for the commenter’s assertion that the revised skin listings are confusing and more complicated to read, we addressed the commenter’s concerns by revising the language in 8.07B2 and 108.07B2 (‘‘Chronic skin lesions or contractures’’), 8.08 and 108.08 (Burns), and 8.09 and 108.09 (Chronic conditions of the skin or mucous membranes), to improve the clarity and readability of these listings. Specifically, we removed repetitive language related to impairment-related limitations. In addition to revising the language in these listings to make the criteria easier to understand and apply, we moved the 8.00D2 and 108.00D2 (Limitation(s) of physical functioning due to skin disorders) cross references from 8.09A to 8.09B and from 108.09A to 108.09B, respectively, to align with the terms they describe. We did not make any other changes to the cross references. Regarding the use of cross references in revised listing 8.09 (Chronic conditions of the skin or mucous membranes), we use cross references throughout the listings for body systems to assist adjudicators, advocates, and lay people with understanding and locating terms 123 84 E:\FR\FM\08JNR2.SGM FR 35936 (2019). 08JNR2 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations ddrumheller on DSK120RN23PROD with RULES2 and phrases specific to the evaluation of certain listing criteria. We also use cross references to assist readers with recalling other listings or rules that affect how we evaluate specific impairments. Comment: One commenter asked that we not replace the plain language term ‘‘flare-ups’’ with the medical term ‘‘exacerbations.’’ Response: We did not adopt the suggestion to remove the term ‘‘exacerbations,’’ but we did add language to reflect the commenter’s request to see ‘‘flare-ups’’ reflected as well. In the final rule, we clarified the definition of the term ‘‘exacerbation.’’ 124 We must use appropriate, modern medical terminology to specify the medical criteria we use to evaluate skin disorders, and our research indicates that ‘‘exacerbation’’ is the preferred term among professionals in the field of dermatology.125 Additionally, we use the term ‘‘exacerbation’’ and not ‘‘flareup’’ throughout the rules for numerous body systems, so adding the word in the listing for skin disorders will allow for consistency across the multiple body systems.126 In this final rule, we added a definition to 8.00B and 108.00B (What are our definitions for the following terms used in this body system?) based on the medical definition for ‘‘exacerbation’’; 127 however, we also mentioned alternative terms such as ‘‘flare’’ and ‘‘flare-up,’’ to reflect the commenter’s desire to see the historical term ‘‘flare-up’’ in the listing. Comment: One commenter stated that many of the terms used in these rules are not defined well enough for adjudicators and the public. The commenter provided the examples of ‘‘inability,’’ ‘‘maintain an upright position,’’ ‘‘fine and gross motor movements,’’ ‘‘picking,’’ ‘‘pinching,’’ ‘‘manipulating and ‘‘fingering,’’ 124 Paragraphs 8.00B7 and 108.00B7 (Exacerbation) of the final rule define exacerbation as ‘‘an increase in the signs or symptoms of the skin disorder.’’ 125 A review of the website for the Journal of the American Medical Association (JAMA), a peerreviewed medical journal published 48 times a year by the American Medical Association, found that the term ‘‘exacerbation’’ was used more than twice as often as the term ‘‘flare-up.’’ 126 We use the term ‘‘exacerbations’’ throughout our respiratory listings (3.00E2, 3.00J, 3.02D, 3.03B, 3.04B, 3.04G, and 3.07, as well as their childhood equivalents), in our current and revised digestive listings (5.00E and 105.00E in the current rules and 5.00D and 105.00D in the revised rule), as well as in the hematological (7.00G), neurological (11.00G, 11.00N1, and 111.00O), mental (12.00F4, 12.00G, 112.00F4, and 112.00G), and the immune listings (14.00I and 114.00I). We do not use the term ‘‘flareup’’ in any other body system. 127 Taber’s Cyclopedic Medical Dictionary—23rd Ed. (2017). VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 ‘‘handling,’’ ‘‘gripping and grasping,’’ ‘‘holding,’’ ‘‘turning,’’ ‘‘reaching,’’ ‘‘lifting and carrying,’’ ‘‘seriously,’’ ‘‘marked,’’ and ‘‘prescribed treatment.’’ Response: We disagree with this comment. This rule uses ‘‘fine and gross movements’’ (not ‘‘fine and gross motor movements’’), which is a term defined in 8.00B5 and 108.00B5 (Fine and gross movements). The majority of the terms identified by this commenter are examples of fine movements 128 and gross movements.129 We use these terms, as well as ‘‘inability,’’ ‘‘maintain,’’ ‘‘upright position,’’ ‘‘prescribed,’’ and ‘‘treatment’’ in this rule as they are defined in common English usage. As we explained in the NPRM, we replaced the current term ‘‘continuing treatment as prescribed’’ with ‘‘adherence to prescribed medical treatment’’ to be consistent with current medical terminology. We changed ‘‘prescribed treatment’’ in 8.00D2 and 108.00D2 (Limitation(s) of physical functioning due to skin disorders) to ‘‘prescribed medical treatment’’ to be consistent with current medical terminology. Further, throughout this rule we provide numerous examples of what we will consider as ‘‘marked’’ limitation(s). Other Comments Comment: One commenter expressed concern that we do not provide quantitative data to show the ‘‘validity’’ of these listings and noted that many people engage in work even though their impairments meet the listing requirements. The commenter opined that this ‘‘challenges the credibility’’ of using the listings to determine whether a person is disabled, and that the listings conflict with the statutory definition of disability. Several other commenters expressed concern that we do not provide any justification for making what they characterize as substantial changes. Response: We did not make any changes in this final rule based on these comments. Contrary to the commenters’ assertion, we provided justification and sources for our changes. In the NPRM, we included an extensive list of references that we relied on in proposing this rule.130 We also invited the public to comment on these references and the data contained within them. The listings help ensure that determinations and decisions of disability have a sound medical basis, 128 Fine movement examples include picking, pinching, manipulating, and fingering. 129 Gross movement examples include handling, gripping, grasping, holding, turning, lifting, and carrying. 130 84 FR 35936 (2019). PO 00000 Frm 00027 Fmt 4701 Sfmt 4700 37729 that claimants receive equal treatment throughout the country, and that we can readily identify a significant number of people who meet our definition of disabled. The level of severity described in the listings is such that we consider a person who is not engaging in SGA, and who has an impairment that meets or medically equals all of the criteria of the listing, to generally be unable to do any gainful activity because of the medical impairment alone at step 3 of the sequential evaluation process. When such impairment or combination of impairments meets or medically equals the level of severity described in the listing for the required duration, we will find the person disabled on the basis of medical facts alone in the absence of evidence to the contrary (for example, the actual performance of SGA). Comment: Two commenters opined that our proposed revisions discriminate against the poor because the criteria in the listings depend on specific diagnoses that, in turn, require medical tests that many people cannot afford and that we will not purchase. The commenters noted that these tests are not specifically required by the listings, but that they still help establish disability for those people who are able to afford them. Response: We did not make any changes in this final rule based on these comments. The Act and our regulations require a claimant to submit medical evidence to establish a medically determinable impairment. We use medical evidence generally accepted in the medical community and available in medical records to establish and determine the severity of an impairment. We consider all available evidence about a claimant’s impairments, not just information about a particular allegation, such as a skin or digestive condition. If we determine a medical source cannot or will not give us sufficient medical evidence about a person’s impairment for us to determine whether a person is disabled, we may also purchase medical examinations or tests to obtain the evidence that we need.131 We can also find a person disabled even if they do not have a medical diagnosis for their impairment(s) when applying for benefits, as long as we are able to establish a medically determinable severe physical or mental impairment or combination of impairments that meets the duration requirements. Comment: One commenter stated that the number of combinations of disorders 131 20 CFR 404.1517, 404.1519, 404.1519a– 404.1519f, 404.1519k, 416.917, 416.919, 416.919a– 419.919f, and 416.919k. E:\FR\FM\08JNR2.SGM 08JNR2 ddrumheller on DSK120RN23PROD with RULES2 37730 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations from different body systems far exceeds the number of disorders in any single body system. For example, if there are 100 different digestive disorders and 100 different skin disorders, there are 10,000 combinations of digestive and skin disorders. The commenter added that our proposed listings only include single disorders and leave out many important combinations of disorders. The commenter stated that we have only covered a tiny fraction of the possible disorders two at a time. The commenter alleged that proposed listings discriminate in favor of those with severe single body system disorders and against those with combinations of disorders. Response: We did not adopt this comment. We recognize that digestive disorders and skin disorders may cooccur with impairments in other body systems. In some cases, the impairment in another body system results from a digestive disorder or a skin disorder. In other cases, the impairment in another body system is not related to the digestive disorder or the skin disorder. We intend the listings for digestive disorders to address digestive disorders and the complications of those disorders. We intend the listings for skin disorders to address skin disorders and the complications of those disorders. When the co-occurring condition or complication is due to a digestive disorder or skin disorder, we evaluate it under the digestive disorders listings or skin disorders listings, as appropriate. However, when the cooccurring impairments are unrelated, we evaluate the combination under our medical equivalence rules (as well as our functional equivalence rules for child claimants) at step 3 of the sequential evaluation, or at steps 4 and 5 of the sequential evaluation process for adult claimants. We evaluate unrelated co-occurring impairments at these steps because adjudicators can account for specific combinations of impairments, complications of those impairments, and limitations of functioning on an individual case basis. We address this in the introductory text of the digestive disorders listings at 5.00J and 105.00L (How do we evaluate digestive disorders that do not meet one of these listings?) and in the introductory text of the skin disorders listings at 8.00I and 108.00I (How do we evaluate skin disorders that do not meet one of these listings?). VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 What is our authority to make rules and set procedures for determining whether a person is disabled under our statutory definition? Under the Act, we have authority to make rules and regulations and to establish necessary and appropriate procedures to carry out such provisions.132 How long will this final rule be in effect? This final rule will remain in effect for 5 years after the date it becomes effective, unless we extend, revise, or issue it again. We will continue to monitor this rule to ensure that it continues to meet program purposes and may revise it before the end of the 5-year period if warranted. How we will implement this final rule? We will begin to apply this final rule to new applications, pending claims, and continuing disability reviews (CDR), as appropriate, as of the effective date of this final rule.133 Regulatory Procedures Executive Order 12866, as Supplemented by Executive Order 13563 We consulted with the Office of Management and Budget (OMB) and determined that this final rule meets the criteria for a significant regulatory action under Executive Order (E.O.) 12866, as supplemented by E.O. 13563 and is subject to OMB review. Therefore, OMB reviewed the rule. Details about the economic impacts of this rule follow. Anticipated Costs to Our Programs In 2018, we conducted a case study covering about 500 initial Disability Determination Service (DDS)-level decisions within the digestive and skin body systems, based on the proposed rule as developed at that time. The case study sample was stratified by specific diagnosis categories and included both listing-level allowances as well as denials at the medical-vocational stage of the disability determination process. Implementation of this final rule would result in decisional changes relative to decisions in these body systems both 132 See sections 205(a), 702(a)(5), and 1631(d)(1) (42 U.S.C. 405(a), 902(a)(5), 1383(d)(1)). 133 We will use the final rule beginning on its effective date. We will apply the final rule to new applications filed on or after the effective date, and to claims that are pending on and after the effective date. This means that we will use the final rule on and after its effective date in any case in which we make a determination or decision, including CDRs, as appropriate. See 20 CFR 404.902 and 416.1402. PO 00000 Frm 00028 Fmt 4701 Sfmt 4700 from allowance to denial and from denial to allowance. Estimates presented below reflect some changes to the final rule from the NPRM. The NPRM was used to develop and conduct the original case study. We conducted several different analyses of the original case study to determine the potential effects of the changes in this final rule on the original case study results. Only one of the changes in this final rule affected the case study results, which was the reversion of changes proposed in the NPRM in the digestive listing for weight loss due to any disorder to the criteria used under current rules. Therefore, we expect no decisional changes under this particular weight loss listing in the final rule relative to current policy. Of the other cases found to be affected by the changes in the proposed rule, we concluded that none of them in the case study would have a different decision under the final rule compared to the evaluation under the proposal as they stood at the time of the original case study. Therefore, based on the results from the case study, we estimate that the combined additional allowances and additional denials under these listings together will likely result in a small net decrease in total allowances for the OldAge, Survivors and Disability Insurance (OASDI) and SSI programs combined, but different effects for each program separately. For the OASDI program, we estimate net changes from the digestive and skin listings individually that are opposite in effect, a net annual average increase in allowances under the digestive listings of about 100 allowances, and a net annual average decrease under the skin listings of about 95 allowances, with the combined net effect being an increase of about five allowances on an annual average basis. This small net increase results in an estimated net increase of $15 million in scheduled OASDI benefit payments for the listings combined over the projection period fiscal years (FY) 2024– 33. For the SSI program, we estimate net reductions for each of the digestive and skin listings individually, with a net annual average decrease in allowances under the digestive listings of about five allowances, and a net annual average decrease in allowances under the skin listings of about 155 allowances, with the net combined effect being a net decrease of about 160 allowances per year on average. These estimated effects are based on a stratified random case study of approximately 425 cases, 175 of which were allowed under the listings in effect prior to publication of this rule, and 250 E:\FR\FM\08JNR2.SGM 08JNR2 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations ddrumheller on DSK120RN23PROD with RULES2 denials. Approximately two-thirds of these cases involved the changes to the digestive listings, and the remaining involved the skin listings. The results of that case study indicated that for each of these listings there would be decisional changes in both directions: some allowances would be denied under these rules, and some denials would be allowed under these rules. The net effects of these changes for the skin listings indicated that the number of cases allowed would be slightly reduced under these new rules for both the OASDI and SSI programs. For the changes to the digestive listings, however, the case study results indicated differing net effects for OASDI and SSI. This is primarily a result of differences in current allowance rates under OASDI and SSI for the specific digestive listings that would be modified by publication of these new rules. OASDI applicants involving digestive impairment have a much lower current allowance rate than similar SSI applicants. Because the case study results indicate changes in both directions, the net effects depend in part on current allowance rates for the listings specifically modified by the changes to the digestive rules. Our actuarial analysis based on these estimated net changes in SSI allowances indicates a net reduction in Federal SSI payments of $51 million for the listings combined over the projection period FY 2024–33. Estimates are based on the assumption that the new rule would apply to all disability determinations completed beginning October 1, 2023. Anticipated Administrative Costs to the Social Security Administration In calculating whether the implementation of this final rule will result in administrative costs or savings to the agency, we examined two sources: (1) Work-years and (2) direct financial administrative costs. We define work-years as a measure of the SSA employee work time this final rule will cost or save during implementation of its policies. We calculate one work-year as 2,080 hours of labor, which represents the amount of hours one SSA employee works per year based on a standard 40-hour workweek. The Office of Budget, Finance, and Management estimates net administrative costs of less than 15 work-years and $2 million annually, which we consider to be a nonsignificant amount. Anticipated Costs to the Public We do not believe there are any more than de minimis costs to the public associated with this rulemaking. As VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 discussed earlier in our responses to comments on the Notice of Proposed Rulemaking as well as in the Paperwork Reduction Action section below, the requirements contained in this rulemaking will not impose new additional costs outside of the normal course of business for applicants or change how the public interacts with our disability programs. Most of the revisions made to the digestive and skin listings improve clarity, readability, and application of the listings as well as consistency among the listings as a whole. We do not believe the requirements contained in the new digestive and skin disorders listings will impose additional costs or documentation requirements to applicants or cause the affected applicants to pursue a different course of treatment than they otherwise would have done under our existing rules. Congressional Review Act This final rule is not a major rule as defined by the Congressional Review Act.134 Executive Order 13132 (Federalism) We analyzed this final rule in accordance with the principles and criteria established by E.O. 13132, and determined that it will not have sufficient Federalism implications to warrant the preparation of a Federalism assessment. We also determined that the final rule will not preempt any State law or State regulations or affect the States’ abilities to discharge traditional State governmental functions. Regulatory Flexibility Act We certify that this final rule will not have a significant economic impact on a substantial number of small entities because it affects individuals only. Therefore, the Regulatory Flexibility Act, as amended, does not require us to prepare a regulatory flexibility analysis. Paperwork Reduction Act This final rule only updates the criteria in the Listing of Impairments (listings) that we use to evaluate disability claims involving both digestive and skin disorders under titles II and XVI of the Social Security Act but does not create any new or affect any existing collections. Accordingly, it does not impose any burdens under the Paperwork Reduction Act and does not require further OMB approval. (Catalog of Federal Domestic Assistance Program Nos. 96.001, Social Security— Disability Insurance; 96.002, Social Security—Retirement Insurance; 96.004, 134 5 PO 00000 U.S.C. 801 et seq. Frm 00029 Fmt 4701 Sfmt 4700 37731 Social Security—Survivors Insurance; and 96.006, Supplemental Security Income) List of Subjects 20 CFR Part 404 Administrative practice and procedure; Blind, Disability benefits; Old-age, survivors, and disability insurance; Reporting and recordkeeping requirements; Social Security. 20 CFR Part 416 Administrative practice and procedure; Aged, Blind, Disability cash payments; Public assistance programs; Reporting and recordkeeping requirements; Supplemental Security Income (SSI). The Acting Commissioner of Social Security, Kilolo Kijakazi, Ph.D., M.S.W., having reviewed and approved this document, is delegating the authority to electronically sign this document to Faye I. Lipsky, who is the primary Federal Register Liaison for the Social Security Administration, for purposes of publication in the Federal Register. Faye I. Lipsky, Federal Register Liaison, Office of Legislation and Congressional Affairs, Social Security Administration. For the reasons set out in the preamble, we are amending subpart P of part 404 of chapter III of title 20 of the Code of Federal Regulations as set forth below: PART 404—FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950–) Subpart P—Determining Disability and Blindness 1. The authority citation for subpart P of part 404 continues to read as follows: ■ Authority: Secs. 202, 205(a)–(b) and (d)– (h), 216(i), 221(a) and (h)–(j), 222(c), 223, 225, and 702(a)(5) of the Social Security Act (42 U.S.C. 402, 405(a)–(b) and (d)–(h), 416(i), 421(a) and (h)–(j), 422(c), 423, 425, and 902(a)(5)); sec. 211(b), Pub. L. 104–193, 110 Stat. 2105, 2189; sec. 202, Pub. L. 108–203, 118 Stat. 509 (42 U.S.C. 902 note). 2. Amend appendix 1 to subpart P of part 404 as follows: ■ a. In the introductory text before part A, revise paragraphs 6 and 9; ■ b. In part A: ■ i. Amend the table of contents for part A by revising the entry for section 5.00; ■ ii. Revise section 5.00; ■ iii. Amend section 6.00 by revising paragraph 6.00C7; ■ iv. Revise section 8.00; ■ v. Amend section 14.00 by revising paragraph 14.00F5; ■ c. In part B: ■ E:\FR\FM\08JNR2.SGM 08JNR2 37732 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations i. Amend the table of contents for part B by revising the entry for section 105.00; ■ ii. Amend section 100.00 by revising paragraph 100.00C2c; ■ iii. Amend section 103.00 by revising paragraph 103.00K2c; ■ iv. Amend section 104.00 by revising paragraph 104.00C3b(iii); ■ v. Revise section 105.00; ■ vi. Amend section 106.00 by revising paragraph 106.00C5b(iii); ■ vi. Revise section 108.00; and ■ viii. Amend section 114.00 by revising paragraph 114.00F7b(iii). The revisions read as follows: ■ Appendix 1 to Subpart P of Part 404— Listing of Impairments * * * * * 6. Digestive Disorders (5.00 and 105.00): October 6, 2028. * * * * * 9. Skin Disorders (8.00 and 108.00): October 6, 2028. * * * * * * * * * * * * * * 5.00 Digestive Disorders * * Part A * ddrumheller on DSK120RN23PROD with RULES2 Sec. * * * 5.00 Digestive Disorders A. Which digestive disorders do we evaluate in this body system? We evaluate digestive disorders that result in severe dysfunction of the liver, pancreas, and gastrointestinal tract (the large, muscular tube that extends from the mouth to the anus, where the movement of muscles, along with the release of hormones and enzymes, allows for the digestion of food) in this body system. Examples of these disorders and the listings we use to evaluate them include chronic liver disease (5.05), inflammatory bowel disease (5.06), and intestinal failure (5.07). We also use this body system to evaluate gastrointestinal hemorrhaging from any cause (5.02), weight loss due to any digestive disorder (5.08), liver transplantation (5.09), small intestine transplantation (5.11), and pancreas transplantation (5.12). We evaluate cancers affecting the digestive system under the listings in 13.00. B. What evidence do we need to evaluate your digestive disorder? 1. General. To establish that you have a digestive disorder, we need medical evidence about the existence of your digestive disorder and its severity. Medical evidence should include your medical history, physical examination findings, operative reports, and relevant laboratory findings. 2. Laboratory findings. We need laboratory reports such as results of imaging (see 5.00B3), endoscopy, and other diagnostic procedures. We may also need clinical laboratory and pathology results. 3. Imaging refers to medical imaging techniques, such as x-ray, ultrasound, magnetic resonance VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 imaging, and computerized tomography. The imaging must be consistent with the prevailing state of medical knowledge and clinical practice as a proper technique to support the evaluation of the disorder. C. What is chronic liver disease (CLD), and how do we evaluate it under 5.05? 1. General. CLD is loss of liver function with cell necrosis (cell death), inflammation, or scarring of the liver that persists for more than 6 months. Common causes of CLD in adults include chronic infection with hepatitis B virus or hepatitis C virus, and prolonged alcohol abuse. a. We will evaluate your signs of CLD, such as jaundice, changes in size of the liver and spleen, ascites, peripheral edema, and altered mental status. We will also evaluate your symptoms of CLD, such as pruritus (itching), fatigue, nausea, loss of appetite, and sleep disturbances when we assess the severity of your impairment(s) and how it affects your ability to function. In the absence of evidence of a chronic liver impairment, episodes of acute liver disease do not meet the requirements of 5.05. b. Laboratory findings of your CLD may include decreased serum albumin, increased International Normalized Ratio (INR), arterial deoxygenation (hypoxemia), increased serum creatinine, oliguria (reduced urine output), or sodium retention. Another laboratory finding that may be included in the evidence is a liver biopsy. If you have had a liver biopsy, we will make every reasonable effort to obtain the results; however, we will not purchase a liver biopsy. 2. Manifestations of CLD. a. Gastrointestinal hemorrhaging (5.05A), as a consequence of cirrhosis and high pressure in the liver’s portal venous system, may occur from varices (dilated veins in the esophagus or the stomach) or from portal hypertensive gastropathy (abnormal mucosal changes in the stomach). When gastrointestinal hemorrhaging is due to a cause other than CLD, we evaluate it under 5.02. The phrase ‘‘consider under a disability for 1 year’’ in 5.02 and 5.05A does not refer to the date on which your disability began, only to the date on which we must reevaluate whether your impairment(s) continues to meet a listing or is otherwise disabling. We determine the onset of your disability based on the facts of your case. b. Ascites or hydrothorax (5.05B) is a pathologic accumulation of fluid in the peritoneal cavity (ascites) or pleural space (hydrothorax). Ascites or hydrothorax may be diagnosed by removing some of the fluid with needle aspiration (paracentesis or thoracentesis), physical examination, or imaging. The most common causes of ascites are portal hypertension and low serum albumin resulting from CLD. We evaluate other causes of ascites and hydrothorax that are unrelated to CLD, such as congestive heart failure and cancer, under the listings in the affected body systems. c. Spontaneous bacterial peritonitis (SBP) (5.05C) is an acute bacterial infection of peritoneal fluid and is most commonly associated with CLD. SBP is diagnosed by laboratory analysis of peritoneal fluid (obtained by paracentesis) that contains a neutrophil count (also called absolute PO 00000 Frm 00030 Fmt 4701 Sfmt 4700 neutrophil count) of at least 250 cells/mm3. 5.05C is satisfied with one evaluation documenting peritoneal infection. We evaluate other causes of peritonitis that are unrelated to CLD, such as tuberculosis, malignancy, and perforated bowel, under the listings in the affected body systems. d. Hepatorenal syndrome (5.05D) is renal failure associated with CLD in the absence of underlying kidney pathology. Findings associated with hepatorenal syndrome include elevation of serum creatinine, sodium retention with low urinary sodium excretion, and oliguria. We evaluate renal dysfunction with known underlying kidney pathology, such as glomerulonephritis, tubular necrosis, and renal infections, under the listings in 6.00. e. Hepatopulmonary syndrome (5.05E) is arterial deoxygenation due to intrapulmonary vascular dilation and arteriovenous shunting associated with CLD. Clinical findings of hepatopulmonary syndrome include platypnea (shortness of breath relieved when lying down) and orthodeoxia (low arterial blood oxygen while in the upright position), when presenting in the context of CLD. We evaluate pulmonary dysfunction with known underlying respiratory pathology, such as asthma, pneumonia, and pulmonary infections, under the listings in 3.00. (i) Under 5.05E1, we require a resting arterial blood gas (ABG) measurement obtained while you are breathing room air; that is, without oxygen supplementation. The ABG report must include the PaO2 value, your name, the date of the test, and either the altitude or both the city and State of the test site. (ii) We will not purchase the specialized imaging techniques described in 5.05E2; however, if you have had the test(s) at a time relevant to your claim, we will make every reasonable effort to obtain the report. f. Hepatic encephalopathy (5.05F), also known as portosystemic encephalopathy, is a recurrent or chronic neuropsychiatric disorder associated with CLD. (i) Under 5.05F2, we require documentation of a mental impairment associated with hepatic encephalopathy. A mental impairment can include abnormal behavior, changes in mental status, or an altered state of consciousness. Reports of abnormal behavior may show that you are experiencing delusions, paranoia, or hallucinations. Reports of changes in mental status may show change in sleep patterns, personality or mood changes, poor concentration, or poor judgment or cognitive dysfunction (for example, impaired memory, poor problem-solving ability, or attention deficits). Reports of altered state of consciousness may show that you are experiencing confusion, delirium, or stupor. (ii) Signs and laboratory findings that document the severity of hepatic encephalopathy when not attributable to other causes may include a ‘‘flapping tremor’’ (asterixis), characteristic abnormalities found on an electroencephalogram (EEG), or abnormal serum albumin or coagulation values. We will not purchase an EEG; however, if you have had this test at a time relevant to your claim, we will make every reasonable effort to obtain the report for the E:\FR\FM\08JNR2.SGM 08JNR2 ddrumheller on DSK120RN23PROD with RULES2 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations purpose of establishing whether your impairment meets the criteria of 5.05F. (iii) We will not evaluate acute encephalopathy under 5.05F if it results from conditions other than CLD. For example, we will evaluate acute encephalopathy caused by vascular events under the listings in 11.00 and acute encephalopathy caused by cancer under the listings in 13.00. 3. SSA Chronic Liver Disease (SSA CLD) score (5.05G). Listing 5.05G requires two SSA CLD scores, each requiring three or four laboratory values. The ‘‘date of the SSA CLD score’’ is the date of the earliest of the three or four laboratory values used for its calculation. The date of the second SSA CLD score must be at least 60 days after the date of the first SSA CLD score and both scores must be within the required 12-month period. If you have the two SSA CLD scores required by 5.05G, we will find that your impairment meets the criteria of the listing from at least the date of the first SSA CLD score. a. We calculate the SSA CLD score using a formula that includes up to four laboratory values: Serum creatinine (mg/dL), total bilirubin (mg/dL), INR, and under certain conditions, serum sodium (mmol/L). The SSA CLD score calculation contains at least one, and sometimes two, parts, as described in (i) and (ii). (i) The initial calculation is: SSA CLDi = 9.57 × [loge(serum creatinine mg/dL)] + 3.78 × [loge(serum total bilirubin mg/dL)] +11.2 × [loge(INR)] + 6.43 rounded to the nearest whole integer. (ii) If the value from the initial calculation is 11 or below, the SSA CLD score will be the SSA CLDi value. If the value from the initial calculation is greater than 11, the SSA CLD score will be re-calculated as: SSA CLD = SSA CLDi + 1.32 × (137¥serum sodium mmol/L) ¥[0.033 × SSA CLDi × (137¥serum sodium mmol/L)] (iii) We round the results of your SSA CLD score calculation to the nearest whole integer to arrive at your SSA CLD score. b. For any SSA CLD score calculation, all of the required laboratory values (serum creatinine, serum total bilirubin, INR, and serum sodium) must have been obtained within a continuous 30-day period. (i) We round values for serum creatinine (mg/dL), serum total bilirubin (mg/dL), or INR less than 1.0 up to 1.0 to calculate your SSA CLD score. (ii) We round values for serum creatinine (mg/dL) greater than 4.0 down to 4.0 to calculate your SSA CLD score. (iii) If there are multiple laboratory values within the 30-day interval for serum creatinine (mg/dL), serum total bilirubin (mg/ dL), or INR, we use the highest value to calculate your SSA CLD score. We will not use any INR values derived from testing done while you are on anticoagulant treatment in our SSA CLD calculation. (iv) If there are multiple laboratory values within the 30-day interval for serum sodium (mmol/L), we use the lowest value to calculate your SSA CLD score. VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 (v) If you are in renal failure or on renal dialysis within a week of any serum creatinine test in the period used for the SSA CLD calculation, we will use a serum creatinine value of 4.0, which is the maximum serum creatinine level allowed in the calculation, to calculate your SSA CLD score. (vi) If your serum sodium is less than 125 mmol/L, we will set your serum sodium to 125 mmol/L for purposes of calculation of the SSA CLD score. If your serum sodium is higher than 137 mmol/L, we will set your serum sodium to 137 mmol/L for purposes of calculation of the SSA CLD score. c. When we indicate ‘‘loge’’ (also abbreviated ‘‘ln’’) in the formula for the SSA CLD score calculation, we mean the ‘‘base e logarithm’’ or ‘‘natural logarithm’’ of the numerical laboratory value, not the ‘‘base 10 logarithm’’ or ‘‘common logarithm’’ (log) of the laboratory value, and not the actual laboratory value. For example, if a person has laboratory values of serum creatinine 1.4 mg/ dL, serum total bilirubin 1.3 mg/dL, INR 1.32, and serum sodium 119 mmol/L, we compute the SSA CLD score as follows: SSA CLDi = 9.57 × [loge(serum creatinine 1.4 mg/dL) = 0.336] + 3.78 × [loge(serum total bilirubin 1.3 mg/ dL) = 0.262] + 11.2 × [loge(INR 1.32) = .278] + 6.43 = 3.22 + 0.99 + 3.11 + 6.43 = 13.75, which we round to an SSA CLDi score of 14. Because the SSA CLDi score is over 11, we then move to the second step of calculating the SSA CLD: SSA CLD = 14 + 1.32 × (137¥serum sodium 125 mmol/L) ¥[0.033 × SSA CLDi 14 × (137¥serum sodium 125 mmol/L) = 14 + 15.84¥5.54 = 24.3, which we round to an SSA CLD score of 24. D. What is inflammatory bowel disease (IBD), and how do we evaluate it under 5.06? 1. IBD is a group of inflammatory conditions of the small intestine and colon. The most common IBD disorders are Crohn’s disease and ulcerative colitis. Remissions and exacerbations of variable duration are a hallmark of IBD. 2. We evaluate your signs and symptoms of IBD, such as diarrhea, fecal incontinence, rectal bleeding, abdominal pain, fatigue, fever, nausea, vomiting, arthralgia, abdominal tenderness, palpable abdominal mass (usually inflamed loops of bowel), and perianal disease (for example, fissure, fistulas, abscesses, or anal canal stenosis), when we assess the severity of your impairment(s). You may require supplemental daily nutrition due to IBD. There are two forms of supplemental daily nutrition we consider under 5.06B5: enteral nutrition (delivered directly to a part of your digestive system) via a gastrostomy, duodenostomy, or jejunostomy, and parenteral nutrition delivered via a central venous catheter. Enteral tube feedings delivered via nasal or oral tubes do not satisfy the requirement in 5.06B5. PO 00000 Frm 00031 Fmt 4701 Sfmt 4700 37733 3. Surgical diversion of the intestinal tract, including ileostomy and colostomy, does not preclude the ability to perform any gainful activity if you are able to maintain adequate nutrition and function of the stoma. However, if you are not able to maintain adequate nutrition, we will evaluate your impairment under 5.08. 4. IBD may also be associated with significant extraintestinal manifestations in a variety of body systems. These include, but are not limited to, involvement of the eye (for example, uveitis, episcleritis, or iritis); hepatobiliary disease (for example, gallstones or primary sclerosing cholangitis); urologic disease (for example, kidney stones or obstructive hydronephrosis); skin involvement (for example, erythema nodosum or pyoderma gangrenosum); or nondestructive inflammatory arthritis. You may also have associated thromboembolic disorders or vascular disease. These manifestations may not correlate with the severity of your IBD. If your impairment does not meet any of the criteria of 5.06, we will consider the effects of your extraintestinal manifestations in determining whether you have an impairment(s) that meets or medically equals another listing, and when we assess your residual functional capacity. 5. Repeated complications of IBD. a. Examples of complications of IBD include abscesses, intestinal perforation, toxic megacolon, infectious colitis, pyoderma gangrenosum, ureteral obstruction, primary sclerosing cholangitis, and hypercoagulable state (which may lead to thromboses or embolism). When we evaluate repeated complications of IBD, we consider all relevant information in your case record to determine the effects of your IBD on your ability to function independently, appropriately, effectively, and on a sustained basis. Factors we consider include, but are not limited to: your symptoms, the frequency and duration of your complications, periods of exacerbation and remission, and the functional effects of your treatment, including the side effects of your medication. Your impairment will satisfy this criterion regardless of whether you have the same kind of complication repeatedly, all different complications, or any other combination of complications; for example, two of the same kind of complication and a different one. b. To satisfy the requirements described under 5.06C, your IBD must result in repeated complications and marked limitation in one of three areas of functioning: activities of daily living; maintaining social functioning; or completing tasks in a timely manner due to deficiencies in concentration, persistence, or pace. If the complications do not last as long or occur as frequently as required under 5.06C, we will consider whether your IBD medically equals the listing. c. Marked limitation means that the signs and symptoms of your IBD interfere seriously with your ability to function. Although we do not require the use of such a scale, ‘‘marked’’ would be the fourth point on a five-point rating scale consisting of no limitation, mild limitation, moderate limitation, marked limitation, and extreme limitation. We do not define ‘‘marked’’ by a specific number of E:\FR\FM\08JNR2.SGM 08JNR2 ddrumheller on DSK120RN23PROD with RULES2 37734 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations activities of daily living or different behaviors in which your social functioning is impaired, or a specific number of tasks that you are able to complete, but by the nature and overall degree of interference with your functioning. You may have marked limitation when several activities or functions are impaired, or when only one is impaired. Additionally, you need not be totally precluded from performing an activity to have marked limitation, as long as the degree of limitation interferes seriously with your ability to function independently, appropriately, and effectively. The term ‘‘marked’’ does not imply that you must be confined to bed, hospitalized, or in a nursing home. d. Activities of daily living include, but are not limited to, such activities as doing household chores, grooming and hygiene, using a post office, taking public transportation, or paying bills. We will find that you have ‘‘marked’’ limitation in activities of daily living if you have a serious limitation in your ability to maintain a household or take public transportation because of symptoms, such as pain, severe fatigue, anxiety, or difficulty concentrating, caused by your IBD (including complications of the disorder) or its treatment, even if you are able to perform some self-care activities. e. Maintaining social functioning includes the capacity to interact independently, appropriately, effectively, and on a sustained basis with others. It includes the ability to communicate effectively with others. We will find that you have ‘‘marked’’ limitation in maintaining social functioning if you have a serious limitation in social interaction on a sustained basis because of symptoms, such as pain, severe fatigue, anxiety, or difficulty concentrating, or a pattern of exacerbation and remission, caused by your IBD (including complications of the disorder) or its treatment, even if you are able to communicate with close friends or relatives. f. Completing tasks in a timely manner due to deficiencies in concentration, persistence, or pace involves the ability to sustain concentration, persistence, or pace to permit timely completion of tasks commonly found in work settings. We will find that you have ‘‘marked’’ limitation in completing tasks if you have a serious limitation in your ability to sustain concentration or pace adequate to complete work-related tasks because of symptoms, such as pain, severe fatigue, anxiety, or difficulty concentrating, caused by your IBD (including complications of the disorder) or its treatment, even if you are able to do some routine activities of daily living. E. What is intestinal failure, and how do we evaluate it under 5.07? 1. Intestinal failure is a condition resulting in gut function below the minimum necessary for the absorption of macronutrients or water and electrolytes, resulting in a requirement for intravenous supplementation (i.e., parenteral nutrition) to maintain health. Examples of conditions that may result in intestinal failure include short bowel syndrome, extensive small bowel mucosal disease, and chronic motility disorders. 2. Short bowel syndrome is a malabsorption disorder that occurs when VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 ischemic vascular insults (caused, for example, by volvulus or necrotizing enterocolitis), trauma, or IBD complications require(s) surgical resection of any amount of the small intestine, resulting in chronic malnutrition. 3. Extensive small bowel mucosal disease means that the mucosal surface of the small bowel does not efficiently absorb nutrients or loses nutrients. Common causes of small bowel mucosal disease include microvillous inclusion disease and tufting enteropathy. 4. Chronic motility disorder refers to a chronic disorder of the propulsion of gut content without fixed obstructions, causing intolerance to oral nutrition and inadequate nutritional intake. This type of disorder may also be known as a chronic intestinal pseudoobstruction (CIPO), because the gut dysfunction mimics that of an obstructed intestine, but without evidence of an actual obstruction. Primary CIPO may have an unknown underlying cause. Chronic motility disorders may also result from congenital, neuromuscular, or autoimmune conditions, such as gastroschisis, omphalocele, long segment Hirschprung’s disease, Crohn’s disease, and mitochondrial disorders. 5. For short bowel syndrome, we require a copy of the operative report that includes details of the surgical findings, or postoperative imaging indicating a resection of the small intestine. If we cannot get one of these reports, we need other medical reports that include details of the surgical findings. For other chronic motility disorders or extensive small bowel mucosal disease, we need medical reports that include details of your intestinal dysfunction. For any impairment evaluated under 5.07, we also need medical documentation that you are dependent on daily parenteral nutrition to provide most of your nutritional requirements. F. How do we evaluate weight loss due to any digestive disorder under 5.08? 1. In addition to the impairments specifically mentioned in these listings, other digestive disorders, such as esophageal stricture, pancreatic insufficiency, and malabsorption, may result in significant weight loss. Impairments other than digestive disorders that cause weight loss should be evaluated under the appropriate body system for that impairment. For instance, weight loss as a result of chronic kidney disease should be evaluated under our rules for genitourinary disorders (see 6.00), and weight loss as the result of an eating disorder should be evaluated under our rules for mental disorders (see 12.00). However, if you develop a digestive disorder as the result of your other impairment, we will evaluate the acquired digestive disorder under our rules for digestive disorders. We evaluate weight loss due to any digestive disorder under 5.08 by using the body mass index (BMI). 2. BMI is the ratio of your weight to the square of your height. Calculation and interpretation of the BMI are independent of gender in adults. a. We calculate BMI using inches and pounds, meters and kilograms, or centimeters and kilograms. We must have measurements of your weight and height without shoes for these calculations. PO 00000 Frm 00032 Fmt 4701 Sfmt 4700 b. We calculate BMI using one of the following formulas: English Formula BMI = [Weight in Pounds/(Height in Inches × Height in Inches)] × 703 Metric Formulas BMI = Weight in Kilograms/(Height in Meters × Height in Meters) BMI = [Weight in Kilograms/(Height in Centimeters × Height in Centimeters)] × 10,000 G. How do we evaluate digestive organ transplantation? If you receive a liver (5.09), small intestine (5.11), or pancreas (5.12) transplant, we will consider you disabled under the listing for 1 year from the date of the transplant. After that, we evaluate your residual impairment(s) by considering the adequacy of your post-transplant function, the frequency and severity of any rejection episodes you have, complications in other body systems, and adverse treatment effects. People who receive digestive organ transplants generally have impairments that meet our definition of disability before they undergo transplantation. The phrase ‘‘consider under a disability for 1 year’’ in 5.09, 5.11, and 5.12 does not refer to the date on which your disability began, only to the date on which we must reevaluate whether your impairment(s) continues to meet a listing or is otherwise disabling. We determine the onset of your disability based on the facts of your case. H. How do we evaluate your digestive disorder if there is no record of ongoing treatment? If there is no record of ongoing treatment despite the existence of a severe impairment(s), we will assess the severity and duration of your digestive disorder based on the current medical and other evidence in your case record. If there is no record of ongoing treatment, you may not be able to show an impairment that meets a digestive disorders listing, but your impairment may medically equal a listing, or be disabling based on consideration of your residual functional capacity, age, education, and work experience. I. How do we evaluate your digestive disorder if there is evidence establishing a substance use disorder? If we find that you are disabled and there is medical evidence in your case record establishing that you have a substance use disorder, we will determine whether your substance use disorder is a contributing factor material to the determination of disability. See §§ 404.1535 and 416.935 of this chapter. Digestive disorders resulting from drug or alcohol use are often chronic in nature and will not necessarily improve with cessation in drug or alcohol use. J. How do we evaluate digestive disorders that do not meet one of these listings? 1. These listings are only examples of common digestive disorders that we consider severe enough to prevent you from doing any gainful activity. If your impairment(s) does not meet the criteria of any of these listings, we must also consider whether you have an impairment(s) that satisfies the criteria of a listing in another body system. 2. If you have a severe medically determinable impairment(s) that does not meet a listing, we will determine whether E:\FR\FM\08JNR2.SGM 08JNR2 ddrumheller on DSK120RN23PROD with RULES2 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations your impairment(s) medically equals a listing. See §§ 404.1526 and 416.926 of this chapter. Digestive disorders may be associated with disorders in other body systems, and we consider the combined effects of multiple impairments when we determine whether they medically equal a listing. If your impairment(s) does not meet or medically equal a listing, you may or may not have the residual functional capacity to engage in substantial gainful activity. We proceed to the fourth step and, if necessary, the fifth step of the sequential evaluation process in §§ 404.1520 and 416.920 of this chapter. We use the rules in §§ 404.1594 and 416.994 of this chapter, as appropriate, when we decide whether you continue to be disabled. 5.01 Category of Impairments, Digestive Disorders 5.02 Gastrointestinal hemorrhaging from any cause, requiring three blood transfusions of at least 2 units of blood per transfusion, within a consecutive 12-month period and at least 30 days apart. Consider under a disability for 1 year following the last documented transfusion; after that, evaluate the residual impairment(s). 5.03–5.04 [Reserved] 5.05 Chronic liver disease (CLD) (see 5.00C) with A, B, C, D, E, F, or G: A. Hemorrhaging from esophageal, gastric, or ectopic varices, or from portal hypertensive gastropathy (see 5.00C2a), documented by imaging (see 5.00B3); resulting in 1 and 2: 1. Hemodynamic instability indicated by signs such as pallor (pale skin), diaphoresis (profuse perspiration), rapid pulse, low blood pressure, postural hypotension (pronounced fall in blood pressure when arising to an upright position from lying down), or syncope (fainting); and 2. Requiring hospitalization for transfusion of at least 2 units of blood. Consider under a disability for 1 year following the documented transfusion; after that, evaluate the residual impairment(s). OR B. Ascites or hydrothorax not attributable to other causes (see 5.00C2b), present on two evaluations within a consecutive 12-month period and at least 60 days apart. Each evaluation must document the ascites or hydrothorax by 1, 2, or 3: 1. Paracentesis; or 2. Thoracentesis; or 3. Imaging or physical examination with a or b: a. Serum albumin of 3.0 g/dL or less; or b. INR of at least 1.5. OR C. Spontaneous bacterial peritonitis (see 5.00C2c) documented by peritoneal fluid containing a neutrophil count of at least 250 cells/mm3. OR D. Hepatorenal syndrome (see 5.00C2d) documented by 1, 2, or 3: 1. Serum creatinine elevation of at least 2 mg/dL; or 2. Oliguria with 24-hour urine output less than 500 mL; or 3. Sodium retention with urine sodium less than 10 mEq per liter. VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 37735 OR OR E. Hepatopulmonary syndrome (see 5.00C2e) documented by 1 or 2: 1. Arterial PaO2 measured by an ABG test, while at rest, breathing room air, less than or equal to: a. 60 mm Hg, at test sites less than 3,000 feet above sea level; or b. 55 mm Hg, at test sites from 3,000 through 6,000 feet above sea level; or c. 50 mm Hg, at test sites over 6,000 feet above sea level; or 2. Intrapulmonary arteriovenous shunting as shown by contrast-enhanced echocardiography or macroaggregated albumin lung perfusion scan. C. Repeated complications of IBD (see 5.00D5a), occurring an average of 3 times a year, or once every 4 months, each lasting 2 weeks or more, within a consecutive 12month period, and marked limitation (see 5.00D5c) in one of the following: 1. Activities of daily living (see 5.00D5d); or 2. Maintaining social functioning (see 5.00D5e); or 3. Completing tasks in a timely manner due to deficiencies in concentration, persistence, or pace (see 5.00D5f). 5.07 Intestinal failure (see 5.00E) due to short bowel syndrome, chronic motility disorders, or extensive small bowel mucosal disease, resulting in dependence on daily parenteral nutrition via a central venous catheter for at least 12 months. 5.08 Weight loss due to any digestive disorder (see 5.00F), despite adherence to prescribed medical treatment, with BMI of less than 17.50 calculated on at least two evaluations at least 60 days apart within a consecutive 12-month period. 5.09 Liver transplantation (see 5.00G). Consider under a disability for 1 year from the date of the transplant; after that, evaluate the residual impairment(s). 5.10 [Reserved] 5.11 Small intestine transplantation (see 5.00G). Consider under a disability for 1 year from the date of the transplant; after that, evaluate the residual impairment(s). 5.12 Pancreas transplantation (see 5.00G). Consider under a disability for 1 year from the date of the transplant; after that, evaluate the residual impairment(s). OR F. Hepatic encephalopathy (see 5.00C2f) with documentation of abnormal behavior, cognitive dysfunction, changes in mental status, or altered state of consciousness (for example, confusion, delirium, stupor, or coma), present on two evaluations within a consecutive 12-month period and at least 60 days apart and either 1 or 2: 1. History of transjugular intrahepatic portosystemic shunt (TIPS) or other surgical portosystemic shunt; or 2. One of the following on at least two evaluations at least 60 days apart within the same consecutive 12-month period as in F: a. Asterixis or other fluctuating physical neurological abnormalities; or b. EEG demonstrating triphasic slow wave activity; or c. Serum albumin of 3.0 g/dL or less; or d. INR of 1.5 or greater. OR G. Two SSA CLD scores (see 5.00C3) of at least 20 within a consecutive 12-month period and at least 60 days apart. Consider under a disability from at least the date of the first score. 5.06 Inflammatory bowel disease (IBD) (see 5.00D) documented by endoscopy, biopsy, imaging, or operative findings, and demonstrated by A, B, or C: A. Obstruction of stenotic areas (not adhesions) in the small intestine or colon with proximal dilatation, confirmed by imaging or in surgery, requiring two hospitalizations for intestinal decompression or for surgery, within a consecutive 12-month period and at least 60 days apart. OR B. Two of the following occurring within a consecutive 12-month period and at least 60 days apart: 1. Anemia with hemoglobin of less than 10.0 g/dL, present on at least two evaluations at least 60 days apart; or 2. Serum albumin of 3.0 g/dL or less, present on at least two evaluations at least 60 days apart; or 3. Clinically documented tender abdominal mass palpable on physical examination with abdominal pain or cramping; or 4. Perianal disease with a draining abscess or fistula; or 5. Need for supplemental daily enteral nutrition via a gastrostomy, duodenostomy, or jejunostomy, or daily parenteral nutrition via a central venous catheter. PO 00000 Frm 00033 Fmt 4701 Sfmt 4700 6.00 Genitourinary Disorders * * * * * C. * * * 7. Anorexia (diminished appetite) with weight loss. Anorexia is a frequent sign of CKD and can result in weight loss. We will use body mass index (BMI) to determine the severity of your weight loss under 6.05B4. (BMI is the ratio of your measured weight to the square of your measured height.) We calculate your BMI using the formulas in the digestive disorders body system (5.00). * * * * * 8.00 Skin Disorders A. Which skin disorders do we evaluate under these listings? We use these listings to evaluate skin disorders that result from hereditary, congenital, or acquired pathological processes. We evaluate genetic photosensitivity disorders (8.07), burns (8.08), and chronic conditions of the skin or mucous membranes such as ichthyosis, bullous disease, dermatitis, psoriasis, and hidradenitis suppurativa (8.09) under these listings. B. What are our definitions for the following terms used in this body system? 1. Assistive device(s): An assistive device, for the purposes of these listings, is any device used to improve stability, dexterity, or mobility. An assistive device can be handheld, such as a cane(s), a crutch(es), or a walker; used in a seated position, such as a wheelchair, rollator, or power operated E:\FR\FM\08JNR2.SGM 08JNR2 ddrumheller on DSK120RN23PROD with RULES2 37736 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations vehicle; or worn, such as a prosthesis or an orthosis. 2. Chronic skin lesions: Chronic skin lesions can have recurrent exacerbations (see 8.00B7). They can occur despite prescribed medical treatment. These chronic skin lesions can develop on any part of your body, including upper extremities, lower extremities, palms of your hands, soles of your feet, the perineum, inguinal (groin) region, and axillae (underarms). Chronic skin lesions may result in functional limitations as described in 8.00D2.3. Contractures: Contractures are permanent fibrous scar tissue resulting in tightening and thickening of skin that prevents normal movement of the damaged area. They can develop on any part of your musculoskeletal system, including upper extremities, lower extremities, palms of your hands, soles of your feet, the perineum, inguinal (groin) region, and axillae (underarms). Contractures may result in functional limitations as described in 8.00D2. 4. Documented medical need: When we use the term ‘‘documented medical need,’’ we mean that there is evidence (see §§ 404.1513 and 416.913 of this chapter) from your medical source(s) in the medical record that supports your need for an assistive device (see 8.00B1) for a continuous period of at least 12 months. The evidence must include documentation from your medical source(s) describing any limitation(s) in your upper or lower extremity functioning that supports your need for the assistive device and describing the circumstances for which you need it. The evidence does not have to include a specific prescription for the device. 5. Fine and gross movements: Fine movements, for the purposes of these listings, involve use of your wrists, hands, and fingers; such movements include picking, pinching, manipulating, and fingering. Gross movements involve use of your shoulders, upper arms, forearms, and hands; such movements include handling, gripping, grasping, holding, turning, and reaching. Gross movements also include exertional activities such as lifting, carrying, pushing, and pulling. 6. Surgical management: For the purposes of these listings, surgical management includes the surgery(ies) itself, as well as various post-surgical procedures, surgical complications, infections or other medical complications, related illnesses, or related treatments that delay a person’s attainment of maximum benefit from surgery. 7. Exacerbation: For the purposes of these listings, exacerbation means an increase in the signs or symptoms of the skin disorder. Exacerbation may also be referred to as flare, flare-up, or worsening of the skin disorder. C. What evidence do we need to evaluate your skin disorder? 1. To establish the presence of a skin disorder as a medically determinable impairment, we need objective medical evidence from an acceptable medical source (AMS) who has examined you for the disorder. 2. We will make every reasonable effort to obtain your medical history, treatment records, and relevant laboratory findings, but we will not purchase genetic testing. VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 3. When we evaluate the presence and severity of your skin disorder(s), we generally need information regarding: a. The onset, duration, and frequency of exacerbations (see 8.00B7); b. The prognosis of your skin disorder; c. The location, size, and appearance of lesions and contractures; d. Any available history of familial incidence; e. Your exposure to toxins, allergens or irritants; seasonal variations; and stress factors; f. Your ability to function outside of a highly protective environment (see 8.00E4); g. Laboratory findings (for example, a biopsy obtained independently of Social Security disability evaluation or results of blood tests); h. Evidence from other medically acceptable methods consistent with the prevailing state of medical knowledge and clinical practice; and i. Statements you or others make about your disorder(s), your restrictions, and your daily activities. D. How do we evaluate the severity of skin disorders? 1. General. We evaluate the severity of skin disorders based on the site(s) of your chronic skin lesions (see 8.00B2) or contractures (see 8.00B3), functional limitations caused by your signs and symptoms (including pain) (see 8.00D2), and how your prescribed treatment affects you. We consider the frequency and severity of your exacerbations (see 8.00B7), how quickly they resolve, and how you function between exacerbations (see 8.00B7), to determine whether your skin disorder meets or medically equals a listing (see 8.00D3). If there is no record of ongoing medical treatment for your disorder, we will follow the guidelines in 8.00D6. We will determine the extent and kinds of evidence we need from medical and non-medical sources based on the individual facts about your disorder. For our basic rules on evidence, see §§ 404.1512, 404.1513, 404.1520b, 416.912, 416.913, and 416.920b of this chapter. For our rules on evaluating your symptoms, see §§ 404.1529 and 416.929 of this chapter. 2. Limitation(s) of physical functioning due to skin disorders. a. Skin disorders may be due to chronic skin lesions (see 8.00B2) or contractures (see 8.00B3), and may cause pain or restrict movement, which can limit your ability to initiate, sustain, and complete work-related activities. For example, skin lesions in the axilla may limit your ability to raise or reach with the affected arm, or lesions in the inguinal region may limit your ability to ambulate, sit, or lift and carry. To evaluate your skin disorder(s) under 8.07B, 8.08, and 8.09, we require medically documented evidence of physical limitation(s) of functioning related to your disorder. The decrease in physical function must have lasted, or can be expected to last, for a continuous period of at least 12 months (see §§ 404.1509 and 416.909 of this chapter). Xeroderma pigmentosum is the only skin disorder that does not include functional criteria because the characteristics and severity of the disorder itself are sufficient to meet the criteria in 8.07A. PO 00000 Frm 00034 Fmt 4701 Sfmt 4700 b. The functional criteria require impairment-related physical limitations in using upper or lower extremities that have lasted, or can be expected to last, for a continuous period of at least 12 months, medically documented by one of the following: (i) Inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete work-related activities involving fine and gross movements (see 8.00B5) due to chronic skin lesions (see 8.00B2) or contractures (see 8.00B3); or (ii) Inability to use one upper extremity to independently initiate, sustain, and complete work-related activities involving fine and gross movements (see 8.00B5) due to chronic skin lesions (see 8.00B2) or contractures (see 8.00B3), and a documented medical need (see 8.00B4) for an assistive device (see 8.00B1) that requires the use of the other upper extremity; or (iii) Inability to stand up from a seated position and maintain an upright position to the extent needed to independently initiate, sustain, and complete work-related activities due to chronic skin lesions (see 8.00B2) or contractures (see 8.00B3) affecting at least two extremities (including when the limitations are due to involvement of the perineum or the inguinal region); or (iv) Inability to maintain an upright position while standing or walking to the extent needed to independently initiate, sustain, and complete work-related activities due to chronic skin lesions (see 8.00B2) or contractures (see 8.00B3) affecting both lower extremities (including when the limitations are due to involvement of the perineum or the inguinal region). 3. Frequency of exacerbations due to chronic skin lesions. A skin disorder resulting in chronic skin lesions (see 8.00B2) may have frequent exacerbations (see 8.00B7) severe enough to meet a listing even if each individual skin lesion exacerbation (see 8.00B7) did not last for an extended amount of time. We will consider the frequency, severity, and duration of skin lesion exacerbations (see 8.00B7), how quickly they resolve, and how you function in the time between skin lesion exacerbations (see 8.00B7), to determine whether your skin disorder meets or medically equals a listing. 4. Symptoms (including pain). Your symptoms may be an important factor in our determination of whether your skin disorder(s) meets or medically equals a listing, or whether you are otherwise able to work. We consider your symptoms only when you have a medically determinable impairment that could reasonably be expected to produce the symptoms. See §§ 404.1529 and 416.929 of this chapter. 5. Treatment. a. General. Treatments for skin disorders may have beneficial or adverse effects, and responses to treatment vary from person to person. Your skin disorder’s response to treatment may vary due to treatment resistance or side effects that can result in functional limitations. We will evaluate all of the effects of treatment (including surgical treatment, medications, and therapy) on the symptoms, signs, and laboratory findings of E:\FR\FM\08JNR2.SGM 08JNR2 ddrumheller on DSK120RN23PROD with RULES2 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations your skin disorder, and on your ability to function. b. Despite adherence to prescribed medical treatment for 3 months. Under 8.09, we require that your symptoms persist ‘‘despite adherence to prescribed medical treatment for 3 months.’’ This requirement means that you must have taken prescribed medication(s) or followed other medical treatment prescribed by a medical source for 3 consecutive months. Treatment or effects of treatment may be temporary. In most cases, sufficient time must elapse to allow us to evaluate your response to treatment, including any side effects. For our purposes, ‘‘sufficient time’’ means a period of at least 3 months. If your treatment has not lasted for at least 3 months, we will follow the rules in 8.00D6a. The 3 months adherence to prescribed medical treatment must be within the period of at least 12 months that we use to evaluate severity. c. Treatment with PUVA (psoralen and ultraviolet A (UVA) light) or biologics. If you receive additional treatment with PUVA or biologics to treat your skin disorder(s), we will defer adjudication of your claim for 6 months from the start of treatment with PUVA or biologics to evaluate the effectiveness of these treatments unless we can make a fully favorable determination or decision on another basis. 6. No record of ongoing treatment. a. Despite having a skin disorder, you may not have received ongoing treatment, may have just begun treatment, may not have access to prescribed medical treatment, or may not have an ongoing relationship with the medical community. In any of these situations, you will not have a longitudinal medical record for us to review when we evaluate your disorder. In some instances, we may be able to assess the severity and duration of your skin disorder based on your medical record and current evidence alone. We may ask you to attend a consultative examination to determine the severity and potential duration of your skin disorder (see §§ 404.1519a and 416.919a of this chapter). b. If, for any reason, you have not received treatment, your skin disorder cannot meet the criteria for 8.09. If the information in your case record is not sufficient to show that you have a skin disorder that meets the criteria of one of the skin disorders listings, we will follow the rules in 8.00I. E. How do we evaluate genetic photosensitivity disorders under 8.07? Genetic photosensitivity disorders are disorders of the skin caused by an increase in the sensitivity of the skin to sources of ultraviolet light, including sunlight. 1. Xeroderma pigmentosum (XP) (8.07A). XP is a genetic photosensitivity disorder with lifelong hypersensitivity to all forms of ultraviolet light. Laboratory testing confirms the diagnosis by documenting abnormalities in the body’s ability to repair DNA (deoxyribonucleic acid) mutations after ultraviolet light exposure. Your skin disorder meets the requirements of 8.07A if you have clinical and laboratory findings supporting a diagnosis of XP (see 8.00E3). 2. Other genetic photosensitivity disorders (8.07B). The effects of other genetic photosensitivity disorders may vary and may VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 not persist over time. To meet the requirements of 8.07B, a genetic photosensitivity disorder other than XP must be established by clinical and laboratory findings (see 8.00C) and must result either in chronic skin lesions (see 8.00B2) or contractures (see 8.00B3) that result in functional limitations (see 8.00D2), or must result in the inability to function outside of a highly protective environment (see 8.00E4). Some genetic photosensitivity disorders can have very serious effects on other body systems, especially special senses and speech, neurological, mental, and cancer. We will evaluate your disorder(s) under the listings in 2.00, 11.00, 12.00, or 13.00, as appropriate. 3. What evidence do we need to document that you have XP or another genetic photosensitivity disorder? We will make a reasonable effort to obtain evidence of your disorder(s), but we will not purchase genetic testing. When the results of genetic tests are part of the existing evidence in your case record, we will evaluate the test results with all other relevant evidence. We need the following clinical and laboratory findings to document that you have XP or another genetic photosensitivity disorder: a. A laboratory report of a definitive genetic test documenting appropriate chromosomal changes, including abnormal DNA repair or another DNA abnormality specific to your type of photosensitivity disorder, signed by an AMS; or b. A laboratory report of a definitive test that is not signed by an AMS, and a report from an AMS stating that you have undergone definitive genetic laboratory studies documenting appropriate chromosomal changes, including abnormal DNA repair or another DNA abnormality specific to your type of photosensitivity disorder; or c. If we do not have a laboratory report of a definitive test, we need documentation from an AMS that an appropriate laboratory analysis or other diagnostic method(s) confirms a positive diagnosis of your skin disorder. This documentation must state that you had the appropriate definitive laboratory test(s) for diagnosing your disorder and provide the results, or explain how another diagnostic method(s), consistent with the prevailing state of medical knowledge and clinical practice, established your diagnosis. 4. Inability to function outside of a highly protective environment means that you must avoid exposure to ultraviolet light (including sunlight passing through windows and light from similar unshielded light sources), wear protective clothing and eyeglasses, and use opaque broad-spectrum sunscreens in order to avoid skin cancer or other serious effects. F. How do we evaluate burns under 8.08? 1. Electrical, chemical, or thermal burns frequently affect other body systems, for example, musculoskeletal, special senses and speech, respiratory, cardiovascular, genitourinary, neurological, or mental. We evaluate burns in the same way we evaluate other disorders that can affect the skin and other body systems, using the listing for the predominant feature of your disorder. For example, if your soft tissue injuries resulting from burns are under surgical management PO 00000 Frm 00035 Fmt 4701 Sfmt 4700 37737 (as defined in 8.00B6), we will evaluate your disorder under the listings in 1.00. 2. We evaluate burns resulting in chronic skin lesions (see 8.00B2) or contractures (see 8.00B3) that have been documented by an AMS to have reached maximum therapeutic benefit and therefore are no longer receiving surgical management, under 8.08. To be disabling, these burns must result in functional limitation(s) (see 8.00D2) that has lasted or can be expected to last for a continuous period of at least 12 months. G. How do we evaluate chronic conditions of the skin or mucous membranes under 8.09? We evaluate skin disorders that result in chronic skin lesions (see 8.00B2) or contractures (see 8.00B3) under 8.09. These disorders must result in chronic skin lesions (see 8.00B2) or contractures (see 8.00B3) that continue to persist despite adherence to prescribed medical treatment for 3 months (see 8.00D5b) and cause functional limitations (see 8.00D2). Examples of skin disorders evaluated under this listing are ichthyosis, bullous diseases (such as pemphigus, epidermolysis bullosa, and dermatitis herpetiformis), chronic skin infections, dermatitis, psoriasis, and hidradenitis suppurativa. H. How do we evaluate disorders in other body systems that affect the skin? When your disorder(s) in another body system affects your skin, we first evaluate the predominant feature of your disorder(s) under the appropriate body system. Examples of disorders in other body systems that may affect the skin include the following: 1. Diabetes mellitus. Diabetes mellitus that is not well controlled, despite treatment, can cause chronic hyperglycemia resulting in serious, long-lasting or recurrent exacerbations (see 8.00B7) or complications. We evaluate those exacerbations (see 8.00B7) or complications under the affected body system(s). If the complication involves soft tissue or amputation(s), we evaluate these features under the listings in 1.00. If the exacerbations (see 8.00B7) or complications involve chronic bacterial or fungal skin lesions resulting from diabetes mellitus, we evaluate your limitations from the skin disorder under listing 8.09. 2. Tuberous sclerosis. The predominant functionally limiting features of tuberous sclerosis are seizures and intellectual disorder or other mental disorders. We evaluate these features under the listings in 11.00 or 12.00, as appropriate. 3. Malignant tumors of the skin. Malignant tumors of the skin (for example, malignant melanomas) are cancers, or malignant neoplastic diseases, that we evaluate under the listings in 13.00. 4. Immune system disorders. We evaluate skin manifestations of immune system disorders such as systemic lupus erythematosus, scleroderma, psoriasis, and human immunodeficiency virus (HIV) infection under the listings in 14.00. 5. Head or facial disfigurement or deformity, and other physical deformities caused by skin disorders. A head or facial disfigurement or deformity may result in loss of your sight, hearing, speech, or ability to chew. In addition to head and facial disfigurement and deformity, other physical E:\FR\FM\08JNR2.SGM 08JNR2 ddrumheller on DSK120RN23PROD with RULES2 37738 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations deformities may result in associated psychological problems (for example, depression). We evaluate the effects of head or facial disfigurement or deformity, or other physical deformities caused by skin disorders under the listings in 1.00, 2.00, 5.00, or 12.00, as appropriate. I. How do we evaluate skin disorders that do not meet one of these listings? 1. These listings are only examples of common skin disorders that we consider severe enough to prevent you from doing any gainful activity. If your impairment(s) does not meet the criteria of any of these listings, we must also consider whether you have an impairment(s) that satisfies the criteria of a listing in another body system. 2. If you have a severe medically determinable impairment(s) that does not meet a listing, we will determine whether your impairment(s) medically equals a listing. See §§ 404.1526 and 416.926 of this chapter. If your impairment(s) does not meet or medically equal a listing, you may or may not have the residual functional capacity to engage in substantial gainful activity. We proceed to the fourth step and, if necessary, the fifth step of the sequential evaluation process in §§ 404.1520 and 416.920 of this chapter. We use the rules in §§ 404.1594 and 416.994 of this chapter, as appropriate, when we decide whether you continue to be disabled. 8.01 Category of Impairments, Skin Disorders 8.02–8.06 [Reserved] 8.07 Genetic photosensitivity disorders, established as described in 8.00E. The requirements of this listing are met if either paragraph A or paragraph B is satisfied. A. Xeroderma pigmentosum (see 8.00E1). OR B. Other genetic photosensitivity disorders (see 8.00E2) with either 1 or 2: 1. Chronic skin lesions (see 8.00B2) or contractures (see 8.00B3) that cause an inability to function outside of a highly protective environment (see 8.00E4); or 2. Chronic skin lesions (see 8.00B2) or contractures (see 8.00B3) causing chronic pain or other physical limitation(s) that result in impairment-related functional limitations (see 8.00D2), as evidenced by: a. Inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete work-related activities involving fine and gross movements (see 8.00B5) due to chronic skin lesions (see 8.00B2) or contractures (see 8.00B3); or b. Inability to use one upper extremity to independently initiate, sustain, and complete work-related activities involving fine and gross movements (see 8.00B5) due to chronic skin lesions (see 8.00B2) or contractures (see 8.00B3), and a documented medical need (see 8.00B4) for an assistive device (see 8.00B1) that requires the use of the other upper extremity; or c. Inability to stand up from a seated position and maintain an upright position to the extent needed to independently initiate, sustain, and complete work-related activities due to chronic skin lesions (see 8.00B2) or contractures (see 8.00B3) affecting at least two extremities (including when the VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 limitations are due to involvement of the perineum or the inguinal region); or d. Inability to maintain an upright position while standing or walking to the extent needed to independently initiate, sustain, and complete work-related activities, due to chronic skin lesions (see 8.00B2) or contractures (see 8.00B3) affecting both lower extremities (including when the limitations are due to involvement of the perineum or the inguinal region). 8.08 Burns (see 8.00F). Burns that do not require continuing surgical management (see 8.00B6), or that have been documented by an acceptable medical source to have reached maximum therapeutic benefit and therefore are no longer receiving surgical management, resulting in chronic skin lesions (see 8.00B2) or contractures (see 8.00B3) causing chronic pain or other physical limitation(s) that result in impairment-related functional limitations (see 8.00D2), as evidenced by: A. Inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete work-related activities involving fine and gross movements (see 8.00B5) due to chronic skin lesions (see 8.00B2) or contractures (see 8.00B3). OR B. Inability to use one upper extremity to independently initiate, sustain, and complete work-related activities involving fine and gross movements (see 8.00B5) due to chronic skin lesions (see 8.00B2) or contractures (see 8.00B3), and a documented medical need (see 8.00B4) for an assistive device (see 8.00B1) that requires the use of the other upper extremity. OR C. Inability to stand up from a seated position and maintain an upright position to the extent needed to independently initiate, sustain, and complete work-related activities due to chronic skin lesions (see 8.00B2) or contractures (see 8.00B3) affecting at least two extremities (including when the limitations are due to involvement of the perineum or the inguinal region). OR D. Inability to maintain an upright position while standing or walking to the extent needed to independently initiate, sustain, and complete work-related activities due to chronic skin lesions (see 8.00B2) or contractures (see 8.00B3) affecting both lower extremities (including when the limitations are due to involvement of the perineum or the inguinal region). 8.09 Chronic conditions of the skin or mucous membranes (see 8.00G) resulting in: A. Chronic skin lesions (see 8.00B2) or contractures (see 8.00B3) causing chronic pain or other physical limitation(s) that persist despite adherence to prescribed medical treatment for 3 months (see 8.00D5b). AND B. Impairment-related functional limitations (see 8.00D2) demonstrated by 1, 2, 3, or 4: 1. Inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete PO 00000 Frm 00036 Fmt 4701 Sfmt 4700 work-related activities involving fine and gross movements (see 8.00B5) due to chronic skin lesions (see 8.00B2) or contractures (see 8.00B3); or 2. Inability to use one upper extremity to independently initiate, sustain, and complete work-related activities involving fine and gross movements (see 8.00B5) due to chronic skin lesions (see 8.00B2) or contractures (see 8.00B3), and a documented medical need (see 8.00B4) for an assistive device (see 8.00B1) that requires the use of the other upper extremity; or 3. Inability to stand up from a seated position and maintain an upright position to the extent needed to independently initiate, sustain, and complete work-related activities due to chronic skin lesions (see 8.00B2) or contractures (see 8.00B3) affecting at least two extremities (including when the limitations are due to involvement of the perineum or the inguinal region); or 4. Inability to maintain an upright position while standing or walking to the extent needed to independently initiate, sustain, and complete work-related activities due to chronic skin lesions (see 8.00B2) or contractures (see 8.00B3) affecting both lower extremities (including when the limitations are due to involvement of the perineum or the inguinal region). * * 14.00 * * * * Immune System Disorders * * * * F. * * * 5. Measurement of CD4 and either body mass index or hemoglobin (14.11G). To evaluate your HIV infection under 14.11G, we require one measurement of your absolute CD4 count or your CD4 percentage, and either a measurement of your body mass index (BMI) or your hemoglobin. These measurements must occur within the period we are considering in connection with your application or continuing disability review. If you have more than one measurement of your CD4 (absolute count or percentage), BMI, or hemoglobin within this period, we will use the lowest of your CD4 (absolute count or percentage), BMI, or hemoglobin. The date of your lowest CD4 (absolute count or percentage) measurement may be different from the date of your lowest BMI or hemoglobin measurement. We calculate your BMI using the formulas in the digestive disorders body system (5.00). * * * * * * * * * * * Part B * * Sec. * * 105.00 * * Digestive Disorders * * * 100.00 Low Birth Weight and Failure to Thrive * * * * * C. * * * 2. * * * c. BMI is the ratio of a child’s weight to the square of his or her height. We calculate BMI using the formulas in the digestive disorders body system (105.00). * E:\FR\FM\08JNR2.SGM * * 08JNR2 * * Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations 103.00 * * Respiratory Disorders * * * K. * * * 2. * * * c. BMI is the ratio of a child’s weight to the square of his or her height. We calculate BMI using the formulas in the digestive disorders body system (105.00). * * 104.00 * * * * * Cardiovascular System * * * C. * * * 3. * * * b. * * * (iii) BMI is the ratio of a child’s weight to the square of his or her height. We calculate BMI using the formulas in the digestive disorders body system (105.00). ddrumheller on DSK120RN23PROD with RULES2 * * * * * 105.00 Digestive Disorders A. Which digestive disorders do we evaluate in this body system? We evaluate digestive disorders that result in severe dysfunction of the liver, pancreas, and gastrointestinal tract (the large, muscular tube that extends from the mouth to the anus, where the movement of muscles, along with the release of hormones and enzymes, allows for the digestion of food) in this body system. Examples of these disorders and the listings we use to evaluate them include chronic liver disease (105.05), inflammatory bowel disease (105.06), and intestinal failure (105.07). We also use this body system to evaluate gastrointestinal hemorrhaging from any cause (105.02), growth failure due to any digestive disorder (105.08), liver transplantation (105.09), need for supplemental daily enteral feeding via a gastrostomy, duodenostomy, or jejunostomy due to any cause for children who have not attained age 3 (105.10), small intestine transplantation (105.11), and pancreas transplantation (105.12). We evaluate cancers affecting the digestive system under the listings in 113.00. B. What evidence do we need to evaluate your digestive disorder? 1. General. To establish that you have a digestive disorder, we need medical evidence about the existence of your digestive disorder and its severity. Medical evidence should include your medical history, physical examination findings, operative reports, and relevant laboratory findings. 2. Laboratory findings. We need laboratory reports such as results of imaging (see 105.00B3), endoscopy, and other diagnostic procedures. We may also need clinical laboratory and pathology results. 3. Imaging refers to medical imaging techniques, such as x-ray, ultrasound, magnetic resonance imaging, and computerized tomography. The imaging must be consistent with the prevailing state of medical knowledge and clinical practice as a proper technique to support the evaluation of the disorder. C. What is chronic liver disease (CLD), and how do we evaluate it under 105.05? 1. General. CLD is loss of liver function with cell necrosis (cell death), inflammation, or scarring of the liver that persists for more than 6 months. Common causes of CLD in VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 children include chronic infection with hepatitis B virus or hepatitis C virus, autoimmune hepatitis, and metabolic disease. a. We will evaluate your signs of CLD, such as jaundice, changes in size of the liver and spleen, ascites, peripheral edema, and altered mental status. We will also evaluate your symptoms of CLD, such as pruritus (itching), fatigue, nausea, loss of appetite, and sleep disturbances when we assess the severity of your impairment(s) and how it affects your ability to function. In the absence of evidence of a chronic liver impairment, episodes of acute liver disease do not meet the requirements of 105.05. b. Laboratory findings of your CLD may include decreased serum albumin, increased International Normalized Ratio (INR), arterial deoxygenation (hypoxemia), increased serum creatinine, oliguria (reduced urine output), or sodium retention. Another laboratory finding that may be included in the evidence is a liver biopsy. If you have had a liver biopsy, we will make every reasonable effort to obtain the results; however, we will not purchase a liver biopsy. 2. Manifestations of CLD. a. Gastrointestinal hemorrhaging (105.05A), as a consequence of cirrhosis and high pressure in the liver’s portal venous system, may occur from varices (dilated veins in the esophagus or the stomach) or from portal hypertensive gastropathy (abnormal mucosal changes in the stomach). When gastrointestinal hemorrhaging is due to a cause other than CLD, we evaluate it under 105.02. The phrase ‘‘consider under a disability for 1 year’’ in 105.02 and 105.05A does not refer to the date on which your disability began, only to the date on which we must reevaluate whether your impairment(s) continues to meet a listing or is otherwise disabling. We determine the onset of your disability based on the facts of your case. b. Ascites or hydrothorax (105.05B) is a pathologic accumulation of fluid in the peritoneal cavity (ascites) or pleural space (hydrothorax). Ascites or hydrothorax may be diagnosed by removing some of the fluid with needle aspiration (paracentesis or thoracentesis), physical examination, or imaging. The most common causes of ascites are portal hypertension and low serum albumin resulting from CLD. We evaluate other causes of ascites and hydrothorax that are unrelated to CLD, such as congestive heart failure and cancer, under the listings in the affected body systems. c. Spontaneous bacterial peritonitis (SBP) (105.05C) is an acute bacterial infection of peritoneal fluid and is most commonly associated with CLD. SBP is diagnosed by laboratory analysis of peritoneal fluid (obtained by paracentesis) that contains a neutrophil count (also called absolute neutrophil count) of at least 250 cells/mm3. 105.05C is satisfied with one evaluation documenting peritoneal infection. We evaluate other causes of peritonitis that are unrelated to CLD, such as tuberculosis, malignancy, and perforated bowel, under the listings in the affected body systems. d. Hepatorenal syndrome (105.05D) is renal failure associated with CLD in the PO 00000 Frm 00037 Fmt 4701 Sfmt 4700 37739 absence of underlying kidney pathology. Findings associated with hepatorenal syndrome include elevation of serum creatinine, sodium retention with low urinary sodium excretion, and oliguria. We evaluate renal dysfunction with known underlying kidney pathology, such as glomerulonephritis, tubular necrosis, and renal infections, under the listings in 106.00. e. Hepatopulmonary syndrome (105.05E) is arterial deoxygenation due to intrapulmonary vascular dilation and arteriovenous shunting associated with CLD. Clinical findings of hepatopulmonary syndrome include platypnea (shortness of breath relieved when lying down) and orthodeoxia (low arterial blood oxygen while in the upright position), when presenting in the context of CLD. We evaluate pulmonary dysfunction with known underlying respiratory pathology, such as asthma, pneumonia, and pulmonary infections, under the listings in 103.00. (i) Under 105.05E1, we require a resting arterial blood gas (ABG) measurement obtained while you are breathing room air; that is, without oxygen supplementation. The ABG report must include the PaO2 value, your name, the date of the test, and either the altitude or both the city and State of the test site. (ii) We will not purchase the specialized imaging techniques described in 105.05E2; however, if you have had the test(s) at a time relevant to your claim, we will make every reasonable effort to obtain the report. f. Hepatic encephalopathy (105.05F), also known as portosystemic encephalopathy, is a recurrent or chronic neuropsychiatric disorder associated with CLD. (i) Under 105.05F2, we require documentation of a mental impairment associated with hepatic encephalopathy. A mental impairment can include abnormal behavior, changes in mental status, or an altered state of consciousness. Reports of abnormal behavior may show that you are experiencing delusions, paranoia, or hallucinations. Reports of changes in mental status may show change in sleep patterns, personality or mood changes, poor concentration, or poor judgment or cognitive dysfunction (for example, impaired memory, poor problem-solving ability, or attention deficits). Reports of altered state of consciousness may show that you are experiencing confusion, delirium, or stupor. (ii) Signs and laboratory findings that document the severity of hepatic encephalopathy when not attributable to other causes may include a ‘‘flapping tremor’’ (asterixis), characteristic abnormalities found on an electroencephalogram (EEG), or abnormal serum albumin or coagulation values. We will not purchase an EEG; however, if you have had this test at a time relevant to your claim, we will make every reasonable effort to obtain the report for the purpose of establishing whether your impairment meets the criteria of 105.05F. (iii) We will not evaluate acute encephalopathy under 105.05F if it results from conditions other than CLD. For example, we will evaluate acute encephalopathy caused by vascular events under the listings in 111.00 and acute encephalopathy caused by cancer under the listings in 113.00. E:\FR\FM\08JNR2.SGM 08JNR2 ddrumheller on DSK120RN23PROD with RULES2 37740 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations 3. SSA Chronic Liver Disease (SSA CLD) and SSA Chronic Liver Disease-Pediatric (SSA CLD–P) scores (105.05G). Listing 105.05G1 requires two SSA CLD scores, each requiring three or four laboratory values. Listing 105.05G2 requires one SSA CLD–P score, which requires four parameters (three laboratory values and growth failure). The ‘‘date of the SSA CLD score’’ is the date of the earliest of the three or four laboratory values used for its calculation. The ‘‘date of the SSA CLD–P score’’ is the date of the earliest of the three laboratory values used for its calculation. For 105.05G1, the date of the second SSA CLD score must be at least 60 days after the date of the first SSA CLD score and both scores must be within the required 12-month period. If you have the two SSA CLD scores required by 105.05G1, we will find that your impairment meets the criteria of the listing from at least the date of the first SSA CLD score. a. SSA CLD score. (i) If you are age 12 or older, we will calculate the SSA CLD score using a formula that includes up to four laboratory values: Serum creatinine (mg/dL), total bilirubin (mg/dL), INR, and under certain conditions, serum sodium (mmol/L). The SSA CLD score calculation contains at least one, and sometimes two, parts, as described in (a) and (b). (a) The initial calculation is: SSA CLDi = + 3.78 × [loge (serum total bilirubin mg/dL)] + 11.2 × [loge (INR)] + 6.43 rounded to the nearest whole integer. (b) If the value from the initial calculation is 11 or below, the SSA CLD score will be the SSA CLDi value. If the value from the initial calculation is greater than 11, the SSA CLD score will be re-calculated as: SSA CLD = SSA CLDi + 1.32 × (137 ¥ serum sodium mmol/L) ¥ [0.033 × SSA CLDi × (137 ¥ serum sodium mmol/L)] (c) We round the results of your SSA CLD score calculation to the nearest whole integer to arrive at your SSA CLD score. (ii) For any SSA CLD score calculation, all of the required laboratory values (serum creatinine, serum total bilirubin, INR, and serum sodium) must have been obtained within a continuous 30-day period. (a) We round values for serum creatinine (mg/dL), serum total bilirubin (mg/dL), or INR less than 1.0 up to 1.0 to calculate your SSA CLD score. (b) We round values for serum creatinine (mg/dL) greater than 4.0 down to 4.0 to calculate your SSA CLD score. (c) If there are multiple laboratory values within the 30-day interval for serum creatinine (mg/dL), serum total bilirubin (mg/ dL), or INR, we use the highest value to calculate your SSA CLD score. We will not use any INR values derived from testing done while you are on anticoagulant treatment in our SSA CLD calculation. (d) If there are multiple laboratory values within the 30-day interval for serum sodium (mmol/L), we use the lowest value to calculate your SSA CLD score. (e) If you are in renal failure or on renal dialysis within a week of any serum VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 creatinine test in the period used for the SSA CLD calculation, we will use a serum creatinine value of 4.0, which is the maximum serum creatinine level allowed in the calculation, to calculate your SSA CLD score. (f) If your serum sodium is less than 125 mmol/L, we will set your serum sodium to 125 mmol/L for purposes of calculation of the SSA CLD score. If your serum sodium is higher than 137 mmol/L, we will set your serum sodium to 137 mmol/L for purposes of calculation of the SSA CLD score. (iii) When we indicate ‘‘loge’’ (also abbreviated ‘‘ln’’) in the formula for the SSA CLD score calculation, we mean the ‘‘base e logarithm’’ or ‘‘natural logarithm’’ of the numerical laboratory value, not the ‘‘base 10 logarithm’’ or ‘‘common logarithm’’ (log) of the laboratory value, and not the actual laboratory value. For example, if a person has laboratory values of serum creatinine 1.4 mg/ dL, serum total bilirubin 1.3 mg/dL, INR 1.32, and serum sodium 119 mmol/L, we compute the SSA CLD score as follows: SSA CLDi = 9.57 × [loge(serum creatinine 1.4 mg/dL) = 0.336] + 3.78 × [loge(serum total bilirubin 1.3 mg/ dL) = 0.262] + 11.2 × [loge(INR 1.32) = .278] + 6.43 = 3.22 + 0.99 + 3.11 + 6.43 = 13.75, which we round to an SSA CLDi score of 14. Because the SSA CLDi score is over 11, we then move to the second step of calculating the SSA CLD: SSA CLD = 14 + 1.32 × (137¥serum sodium 125 mmol/L) ¥[0.033 × SSA CLDi 14 × (137¥serum sodium 125 mmol/L) = 14 + 15.84¥5.54 = 24.3, which we round to an SSA CLD score of 24. b. SSA CLD–P score (i) We calculate the SSA CLD–P score using a formula that includes four parameters: Serum total bilirubin (mg/dL), INR, serum albumin (g/dL), and whether you have growth failure. The formula for the SSA CLD–P score calculation is: 4.80 × [loge(serum total bilirubin mg/dL)] + 18.57 × [loge(INR)] ¥6.87 × [loge(serum albumin g/dL)] + 6.67 if you have growth failure (<¥2 standard deviations for weight or height) (ii) When we indicate ‘‘loge’’ in the formula for the SSA CLD–P score calculation, we mean the ‘‘base e logarithm’’ or ‘‘natural logarithm’’ (loge) of a numerical laboratory value, not the ‘‘base 10 logarithm’’ or ‘‘common logarithm’’ (log) of the laboratory value, and not the actual laboratory value. For example, if a female child is 4.0 years old, has growth failure, and has laboratory values of serum total bilirubin 2.2 mg/dL, INR 1.0, and serum albumin 3.5 g/dL, we compute the SSA CLD–P score as follows: 4.80 × [loge(serum total bilirubin 2.2 mg/dL) = 0.788] + 18.57 × [loge(INR 1.0) = 0] ¥6.87 × [loge(serum albumin 3.5 g/dL) = 1.253] PO 00000 Frm 00038 Fmt 4701 Sfmt 4700 + 6.67 = 3.78 + 0¥8.61 + 6.67 = 1.84, which we round to an SSA CLD–P score of 2. (iii) For an SSA CLD–P score calculation, all of the required laboratory values (serum total bilirubin, INR, and serum albumin) must have been obtained within a continuous 30-day period. We round any of the required laboratory values less than 1.0 up to 1.0 to calculate your SSA CLD–P score. If there are multiple laboratory values within the 30-day interval for any given laboratory test, we use the highest serum total bilirubin and INR values and the lowest serum albumin value to calculate the SSA CLD–P score. We will not use any INR values derived from testing done while you are on anticoagulant treatment in our SSA CLD–P calculation. We will not purchase INR values for children who have not attained age 12. If there is no INR value for a child under 12 within the applicable period, we will use an INR value of 1.1 to calculate the SSA CLD–P score. We round the results of your SSA CLD–P score calculation to the nearest whole integer to arrive at your SSA CLD–P score. (iv) The weight and length/height measurements used for the calculation must be obtained within the same 30-day period as the laboratory values. 4. Extrahepatic biliary atresia (105.05H) presents itself in the first 2 months of life with persistent jaundice. To satisfy 105.05H, the diagnosis of extrahepatic biliary atresia must be confirmed by liver biopsy or intraoperative cholangiogram that shows obliteration of the extrahepatic biliary tree. Biliary atresia is usually treated surgically by portoenterostomy (for example, Kasai procedure). If this surgery is not performed in the first months of life or is not completely successful, liver transplantation is indicated. If you have received a liver transplant, we will evaluate your impairment under 105.09. The phrase ‘‘consider under a disability for 1 year’’ in 105.05H does not refer to the date on which your disability began, only to the date on which we must reevaluate whether your impairment(s) continues to meet a listing or is otherwise disabling. We determine the onset of your disability based on the facts of your case. D. What is inflammatory bowel disease (IBD), and how do we evaluate it under 105.06? 1. IBD is a group of inflammatory conditions of the small intestine and colon. The most common IBD disorders are Crohn’s disease and ulcerative colitis. Remissions and exacerbations of variable duration are a hallmark of IBD. 2. We evaluate your signs and symptoms of IBD, such as diarrhea, fecal incontinence, rectal bleeding, abdominal pain, fatigue, fever, nausea, vomiting, arthralgia, abdominal tenderness, palpable abdominal mass (usually inflamed loops of bowel), and perianal disease (for example, fissure, fistulas, abscesses, or anal canal stenosis), when we assess the severity of your impairment(s). You may require supplemental daily nutrition due to IBD. There are two forms of supplemental daily nutrition we consider under 105.06B5: enteral nutrition (delivered directly to a part E:\FR\FM\08JNR2.SGM 08JNR2 ddrumheller on DSK120RN23PROD with RULES2 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations of your digestive system) via a gastrostomy, duodenostomy, or jejunostomy, and parenteral nutrition delivered via a central venous catheter. Enteral tube feedings delivered via nasal or oral tubes do not satisfy the requirement in 105.06B5. 3. Surgical diversion of the intestinal tract, including ileostomy and colostomy, does not very seriously interfere with age-appropriate functioning if you are able to maintain adequate nutrition and function of the stoma. However, if you are not able to maintain adequate nutrition, we will evaluate your impairment under 105.08. 4. IBD may be associated with significant extraintestinal manifestations in a variety of body systems. These include, but are not limited to, involvement of the eye (for example, uveitis, episcleritis, or iritis); hepatobiliary disease (for example, gallstones or primary sclerosing cholangitis); urologic disease (for example, kidney stones or obstructive hydronephrosis); skin involvement (for example, erythema nodosum or pyoderma gangrenosum); or nondestructive inflammatory arthritis. You may also have associated thromboembolic disorders or vascular disease. These manifestations may not correlate with the severity of your IBD. If your impairment does not meet any of the criteria of 105.06, we will consider the effects of your extraintestinal manifestations in determining whether you have an impairment(s) that meets or medically equals another listing, and when we determine whether your impairment(s) functionally equals the listings. 5. Examples of complications of IBD that may result in hospitalization include abscesses, intestinal perforation, toxic megacolon, infectious colitis, pyoderma gangrenosum, ureteral obstruction, primary sclerosing cholangitis, and hypercoagulable state (which may lead to thromboses or embolism). E. What is intestinal failure, and how do we evaluate it under 105.07? 1. Intestinal failure is a condition resulting in gut function below the minimum necessary for the absorption of macronutrients or water and electrolytes, resulting in a requirement for intravenous supplementation (i.e., parenteral nutrition) to maintain health. Examples of conditions that may result in intestinal failure include short bowel syndrome, extensive small bowel mucosal disease, and chronic motility disorders. 2. Short bowel syndrome is a malabsorption disorder that occurs when ischemic vascular insults (caused, for example, by volvulus or necrotizing enterocolitis), trauma, or IBD complications require(s) surgical resection of any amount of the small intestine, resulting in chronic malnutrition. 3. Extensive small bowel mucosal disease means that the mucosal surface of the small bowel does not efficiently absorb nutrients or loses nutrients. Common causes of small bowel mucosal disease include microvillous inclusion disease and tufting enteropathy. 4. Chronic motility disorder refers to a chronic disorder of the propulsion of gut content without fixed obstructions, causing intolerance to oral nutrition and inadequate VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 nutritional intake. This type of disorder may also be known as a chronic intestinal pseudoobstruction (CIPO), because the gut dysfunction mimics that of an obstructed intestine, but without evidence of an actual obstruction. Primary CIPO may have an unknown underlying cause. Chronic motility disorders may also result from congenital, neuromuscular, or autoimmune conditions, such as gastroschisis, omphalocele, long segment Hirschprung’s disease, Crohn’s disease, and mitochondrial disorders. 5. For short bowel syndrome, we require a copy of the operative report that includes details of the surgical findings, or postoperative imaging indicating a resection of the small intestine. If we cannot get one of these reports, we need other medical reports that include details of the surgical findings. For other chronic motility disorders or extensive small bowel mucosal disease, we need medical reports that include details of your intestinal dysfunction. For any impairment evaluated under 105.07, we also need medical documentation that you are dependent on daily parenteral nutrition to provide most of your nutritional requirements. F. How do we evaluate growth failure due to any digestive disorder under 105.08? 1. To evaluate growth failure due to any digestive disorder, we require documentation of the laboratory findings of chronic nutritional deficiency described in 105.08A and the growth measurements in 105.08B within the same consecutive 12-month period. The dates of laboratory findings may be different from the dates of growth measurements. Impairments other than digestive disorders that cause weight loss should be evaluated under the appropriate body system. For instance, weight loss as a result of chronic kidney disease should be evaluated under our rules for genitourinary disorders (see 106.00), and weight loss as the result of an eating disorder should be evaluated under our rules for mental disorders (see 112.00). However, if you develop a digestive disorder as the result of your other impairment, we will evaluate the acquired digestive disorder under our rules for digestive disorders. 2. Under 105.08B, we evaluate a child’s growth failure by using the appropriate table for age and gender. a. For children from birth to attainment of age 2, we use the weight-for-length table (see Table I or Table II). b. For children age 2 to attainment of age 18, we use the body mass index (BMI)-for-age table (see Table III or Table IV). c. BMI is the ratio of your weight to the square of your height. We calculate BMI using one of the following formulas: English Formula BMI = [Weight in Pounds/(Height in Inches × Height in Inches)] × 703 Metric Formulas BMI = Weight in Kilograms/(Height in Meters × Height in Meters) BMI = [Weight in Kilograms/(Height in Centimeters × Height in Centimeters)] × 10,000 G. How do we evaluate digestive organ transplantation? If you receive a liver (105.09), small intestine (105.11), or pancreas PO 00000 Frm 00039 Fmt 4701 Sfmt 4700 37741 (105.12) transplant, we will consider you disabled under the listing for 1 year from the date of the transplant. After that, we evaluate your residual impairment(s) by considering the adequacy of your post-transplant function, the frequency and severity of any rejection episodes you have, complications in other body systems, and adverse treatment effects. People who receive digestive organ transplants generally have impairments that meet our definition of disability before they undergo transplantation. The phrase ‘‘consider under a disability for 1 year’’ in 105.09, 105.11, and 105.12 does not refer to the date on which your disability began, only to the date on which we must reevaluate whether your impairment(s) continues to meet a listing or is otherwise disabling. We determine the onset of your disability based on the facts of your case. H. How do we evaluate the need for supplemental daily enteral feeding via a gastrostomy, duodenostomy, or jejunostomy? We evaluate the need for supplemental daily enteral feeding via a gastrostomy, duodenostomy, or jejunostomy in children who have not attained age 3 under 105.10 regardless of the medical reason for the stoma. Enteral tube feedings delivered via nasal or oral tubes do not satisfy the requirement in 105.10. After a child attains age 3, we evaluate growth failure due to any digestive disorder under 105.08, IBD requiring supplemental daily enteral or parenteral nutrition under 105.06, or other medical or developmental disorders under another digestive disorders listing or under a listing in an affected body system(s). I. How do we evaluate esophageal stricture or stenosis? Esophageal stricture or stenosis (narrowing) from congenital atresia (absence or abnormal closure of a tubular body organ) or destructive esophagitis may result in malnutrition or the need for gastrostomy placement, which we evaluate under 105.08 or 105.10. Esophageal stricture or stenosis may also result in complications such as pneumonias due to frequent aspiration, or difficulty in maintaining nutritional status short of listing level severity. While these individual complications usually do not meet the listing criteria, a combination of your impairments may medically equal a listing or functionally equal the listings. J. How do we evaluate your digestive disorder if there is no record of ongoing treatment? If there is no record of ongoing treatment despite the existence of a severe impairment(s), we will assess the severity and duration of your digestive disorder based on the current medical and other evidence in your case record. If there is no record of ongoing treatment, you may not be able to show an impairment that meets a digestive disorders listing, but your impairment may medically equal a listing, or be disabling based on our rules for functional equivalence. K. How do we evaluate your digestive disorder if there is evidence establishing a substance use disorder? If we find that you are disabled and there is medical evidence in your case record establishing that you have a substance use disorder, we will determine whether your substance use disorder is a contributing factor material to the E:\FR\FM\08JNR2.SGM 08JNR2 ddrumheller on DSK120RN23PROD with RULES2 37742 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations determination of disability. See § 416.935 of this chapter. Digestive disorders resulting from drug or alcohol use are often chronic in nature and will not necessarily improve with cessation in drug or alcohol use. L. How do we evaluate digestive disorders that do not meet one of these listings? 1. These listings are only examples of common digestive disorders that we consider severe enough to result in marked and severe functional limitations. If your impairment(s) does not meet the criteria of any of these listings, we must also consider whether you have an impairment(s) that satisfies the criteria of a listing in another body system. 2. If you have a severe medically determinable impairment(s) that does not meet a listing, we will determine whether your impairment(s) medically equals a listing. See § 416.926 of this chapter. Digestive disorders may be associated with disorders in other body systems, and we consider the combined effects of multiple impairments when we determine whether they medically equal a listing. If your impairment(s) does not meet or medically equal a listing, we will also consider whether it functionally equals the listings. See § 416.926a of this chapter. We use the rules in § 416.994a of this chapter when we decide whether you continue to be disabled. 105.01 Category of Impairments, Digestive Disorders 105.02 Gastrointestinal hemorrhaging from any cause, requiring three blood transfusions of at least 10 cc of blood/kg of body weight per transfusion, within a consecutive 12-month period and at least 30 days apart. Consider under a disability for 1 year following the last documented transfusion; after that, evaluate the residual impairment(s). 105.03–105.04 [Reserved] 105.05 Chronic liver disease (CLD) (see 105.00C) with A, B, C, D, E, F, G, or H: A. Hemorrhaging from esophageal, gastric, or ectopic varices, or from portal hypertensive gastropathy (see 105.00C2a), documented by imaging (see 105.00B3); resulting in 1 and 2: 1. Hemodynamic instability indicated by signs such as pallor (pale skin), diaphoresis (profuse perspiration), rapid pulse, low blood pressure, postural hypotension (pronounced fall in blood pressure when arising to an upright position from lying down), or syncope (fainting); and 2. Requiring hospitalization for transfusion of at least 10 cc of blood/kg of body weight. Consider under a disability for 1 year following the documented transfusion; after that, evaluate the residual impairment(s). OR B. Ascites or hydrothorax not attributable to other causes (see 105.00C2b), present on two evaluations within a consecutive 12month period and at least 60 days apart. Each evaluation must document the ascites or hydrothorax by 1, 2, or 3: VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 1. Paracentesis; or 2. Thoracentesis; or 3. Imaging or physical examination with a or b: a. Serum albumin of 3.0 g/dL or less; or b. INR of at least 1.5. OR C. Spontaneous bacterial peritonitis (see 105.00C2c) documented by peritoneal fluid containing a neutrophil count of at least 250 cells/mm3. OR D. Hepatorenal syndrome (see 105.00C2d) documented by 1, 2, or 3: 1. Serum creatinine elevation of at least 2 mg/dL; or 2. Oliguria with 24-hour urine output less than 1 mL/kg/hr; or 3. Sodium retention with urine sodium less than 10 mEq per liter. OR E. Hepatopulmonary syndrome (see 105.00C2e) documented by 1 or 2: 1. Arterial PaO2 measured by an ABG test, while at rest, breathing room air, less than or equal to: a. 60 mm Hg, at test sites less than 3,000 feet above sea level; or b. 55 mm Hg, at test sites from 3,000 through 6,000 feet above sea level; or c. 50 mm Hg, at test sites over 6,000 feet above sea level; or 2. Intrapulmonary arteriovenous shunting as shown on contrast-enhanced echocardiography or macroaggregated albumin lung perfusion scan. OR F. Hepatic encephalopathy (see 105.00C2f) with documentation of abnormal behavior, cognitive dysfunction, changes in mental status, or altered state of consciousness (for example, confusion, delirium, stupor, or coma), present on two evaluations within a consecutive 12-month period and at least 60 days apart and either 1 or 2: 1. History of transjugular intrahepatic portosystemic shunt (TIPS) or other surgical portosystemic shunt; or 2. One of the following on at least two evaluations at least 60 days apart within the same consecutive 12-month period as in F: a. Asterixis or other fluctuating physical neurological abnormalities; or b. EEG demonstrating triphasic slow wave activity; or c. Serum albumin of 3.0 g/dL or less; or d. INR of 1.5 or greater. OR G. SSA CLD or SSA CLD–P scores (see 105.00C3): 1. For children age 12 or older, two SSA CLD scores of at least 20 within a consecutive 12-month period and at least 60 days apart. Consider under a disability from at least the date of the first score; or PO 00000 Frm 00040 Fmt 4701 Sfmt 4700 2. For children who have not attained age 12, one SSA CLD–P score of at least 11. OR H. Extrahepatic biliary atresia as diagnosed on liver biopsy or intraoperative cholangiogram (see 105.00C4). Consider under a disability for 1 year following diagnosis; after that, evaluate the residual impairment(s). 105.06 Inflammatory bowel disease (IBD) (see 105.00D) documented by endoscopy, biopsy, imaging, or operative findings and demonstrated by A or B: A. Obstruction of stenotic areas (not adhesions) in the small intestine or colon with proximal dilatation, confirmed by imaging or in surgery, requiring two hospitalizations for intestinal decompression or for surgery, within a consecutive 12-month period and at least 60 days apart. OR B. Two of the following occurring within a consecutive 12-month period and at least 60 days apart: 1. Anemia with hemoglobin less than 10.0 g/dL, present on at least two evaluations at least 60 days apart; or 2. Serum albumin of 3.0 g/dL or less, present on at least two evaluations at least 60 days apart; or 3. Clinically documented tender abdominal mass palpable on physical examination with abdominal pain or cramping; or 4. Perianal disease with a draining abscess or fistula; or 5. Need for supplemental daily enteral nutrition via a gastrostomy, duodenostomy, or jejunostomy, or daily parenteral nutrition via a central venous catheter (see 105.10 for children who have not attained age 3). 105.07 Intestinal failure (see 105.00E) due to short bowel syndrome, chronic motility disorders, or extensive small bowel mucosal disease, resulting in dependence on daily parenteral nutrition via a central venous catheter for at least 12 months. 105.08 Growth failure due to any digestive disorder (see 105.00F), documented by A and B: A. Chronic nutritional deficiency present on two evaluations within a consecutive 12month period and at least 60 days apart documented by 1 or 2: 1. Anemia with hemoglobin less than 10.0 g/dL; or 2. Serum albumin of 3.0 g/dL or less. AND B. Growth failure as required in 1 or 2: 1. For children from birth to attainment of age 2, three weight-for-length measurements that are: a. Within a consecutive 12-month period; and b. At least 60 days apart; and c. Less than the third percentile values in Table I or Table II; or E:\FR\FM\08JNR2.SGM 08JNR2 37743 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations TABLE I—MALES BIRTH TO ATTAINMENT OF AGE 2 [Third percentile values for weight-for-length] Length (centimeters) Weight (kilograms) Length (centimeters) Weight (kilograms) Length (centimeters) Weight (kilograms) 45.0 45.5 46.5 47.5 48.5 49.5 50.5 51.5 52.5 53.5 54.5 55.5 56.5 57.5 58.5 59.5 60.5 61.5 62.5 63.5 1.597 1.703 1.919 2.139 2.364 2.592 2.824 3.058 3.294 3.532 3.771 4.010 4.250 4.489 4.728 4.966 5.203 5.438 5.671 5.903 64.5 65.5 66.5 67.5 68.5 69.5 70.5 71.5 72.5 73.5 74.5 75.5 76.5 77.5 78.5 79.5 80.5 81.5 82.5 83.5 6.132 6.359 6.584 6.807 7.027 7.245 7.461 7.674 7.885 8.094 8.301 8.507 8.710 8.913 9.113 9.313 9.512 9.710 9.907 10.104 84.5 85.5 86.5 87.5 88.5 89.5 90.5 91.5 92.5 93.5 94.5 95.5 96.5 97.5 98.5 99.5 100.5 101.5 102.5 103.5 10.301 10.499 10.696 10.895 11.095 11.296 11.498 11.703 11.910 12.119 12.331 12.546 12.764 12.987 13.213 13.443 13.678 13.918 14.163 14.413 TABLE II—FEMALES BIRTH TO ATTAINMENT OF AGE 2 [Third percentile values for weight-for-length] Length (centimeters) Weight (kilograms) Length (centimeters) Weight (kilograms) Length (centimeters) Weight (kilograms) 45.0 45.5 46.5 47.5 48.5 49.5 50.5 51.5 52.5 53.5 54.5 55.5 56.5 57.5 58.5 59.5 60.5 61.5 62.5 63.5 1.613 1.724 1.946 2.171 2.397 2.624 2.852 3.081 3.310 3.538 3.767 3.994 4.220 4.445 4.669 4.892 5.113 5.333 5.552 5.769 64.5 65.5 66.5 67.5 68.5 69.5 70.5 71.5 72.5 73.5 74.5 75.5 76.5 77.5 78.5 79.5 80.5 81.5 82.5 83.5 5.985 6.200 6.413 6.625 6.836 7.046 7.254 7.461 7.667 7.871 8.075 8.277 8.479 8.679 8.879 9.078 9.277 9.476 9.674 9.872 84.5 85.5 86.5 87.5 88.5 89.5 90.5 91.5 92.5 93.5 94.5 95.5 96.5 97.5 98.5 99.5 100.5 101.5 102.5 103.5 10.071 10.270 10.469 10.670 10.871 11.074 11.278 11.484 11.691 11.901 12.112 12.326 12.541 12.760 12.981 13.205 13.431 13.661 13.895 14.132 2. For children age 2 to attainment of age 18, three BMI-for-age measurements that are: a. Within a consecutive 12-month period; and b. At least 60 days apart; and c. Less than the third percentile value in Table III or Table IV. TABLE III—MALES AGE 2 TO ATTAINMENT OF AGE 18 ddrumheller on DSK120RN23PROD with RULES2 [Third percentile values for BMI-for-age] Age (yrs. and mos.) BMI Age (yrs. and mos.) BMI Age (yrs. and mos.) BMI 2.0 to 2.1 2.2 to 2.4 2.5 to 2.7 2.8 to 2.11 3.0 to 3.2 3.3 to 3.6 3.7 to 3.11 4.0 to 4.5 14.5 14.4 14.3 14.2 14.1 14.0 13.9 13.8 10.11 to 11.2 11.3 to 11.5 11.6 to 11.8 11.9 to 11.11 12.0 to 12.1 12.2 to 12.4 12.5 to 12.7 12.8 to 12.9 14.3 14.4 14.5 14.6 14.7 14.8 14.9 15.0 14.9 to 14.10 14.11 to 15.0 15.1 to 15.3 15.4 to 15.5 15.6 to 15.7 15.8 to 15.9 15.10 to 15.11 16.0 to 16.1 16.1 16.2 16.3 16.4 16.5 16.6 16.7 16.8 VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 PO 00000 Frm 00041 Fmt 4701 Sfmt 4700 E:\FR\FM\08JNR2.SGM 08JNR2 37744 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations TABLE III—MALES AGE 2 TO ATTAINMENT OF AGE 18—Continued [Third percentile values for BMI-for-age] Age (yrs. and mos.) BMI Age (yrs. and mos.) BMI Age (yrs. and mos.) BMI 4.6 to 5.0 5.1 to 6.0 6.1 to 7.6 7.7 to 8.6 8.7 to 9.1 9.2 to 9.6 9.7 to 9.11 10.0 to 10.3 10.4 to 10.7 10.8 to 10.10 13.7 13.6 13.5 13.6 13.7 13.8 13.9 14.0 14.1 14.2 12.10 to 13.0 13.1 to 13.2 13.3 to 13.4 13.5 to 13.7 13.8 to 13.9 13.10 to 13.11 14.0 to 14.1 14.2 to 14.4 14.5 to 14.6 14.7 to 14.8 15.1 15.2 15.3 15.4 15.5 15.6 15.7 15.8 15.9 16.0 16.2 to 16.3 16.4 to 16.5 16.6 to 16.8 16.9 to 16.10 16.11 to 17.0 17.1 to 17.2 17.3 to 17.5 17.6 to 17.7 17.8 to 17.9 17.10 to 17.11 16.9 17.0 17.1 17.2 17.3 17.4 17.5 17.6 17.7 17.8 TABLE IV—FEMALES AGE 2 TO ATTAINMENT OF AGE 18 [Third percentile values for BMI-for-age] Age (yrs. and mos.) BMI Age (yrs. and mos.) BMI Age (yrs. and mos.) BMI 2.0 to 2.2 2.3 to 2.6 2.7 to 2.10 2.11 to 3.2 3.3 to 3.6 3.7 to 3.11 4.0 to 4.4 4.5 to 4.11 5.0 to 5.9 5.10 to 7.6 7.7 to 8.4 8.5 to 8.10 8.11 to 9.3 9.4 to 9.8 9.9 to 10.0 10.1 to 10.4 10.5 to 10.7 14.1 14.0 13.9 13.8 13.7 13.6 13.5 13.4 13.3 13.2 13.3 13.4 13.5 13.6 13.7 13.8 13.9 10.8 to 10.10 10.11 to 11.2 11.3 to 11.5 11.6 to 11.7 11.8 to 11.10 11.11 to 12.1 12.2 to 12.4 12.5 to 12.6 12.7 to 12.9 12.10 to 12.11 13.0 to 13.2 13.3 to 13.4 13.5 to 13.7 13.8 to 13.9 13.10 to 14.0 14.1 to 14.2 ................................... 14.0 14.1 14.2 14.3 14.4 14.5 14.6 14.7 14.8 14.9 15.0 15.1 15.2 15.3 15.4 15.5 ................................... 14.3 to 14.5 14.6 to 14.7 14.8 to 14.9 14.10 to 15.0 15.1 to 15.2 15.3 to 15.5 15.6 to 15.7 15.8 to 15.10 15.11 to 16.0 16.1 to 16.3 16.4 to 16.6 16.7 to 16.9 16.10 to 17.0 17.1 to 17.3 17.4 to 17.7 17.8 to 17.11 ................................... 15.6 15.7 15.8 15.9 16.0 16.1 16.2 16.3 16.4 16.5 16.6 16.7 16.8 16.9 17.0 17.1 ................................... ddrumheller on DSK120RN23PROD with RULES2 105.09 Liver transplantation (see 105.00G). Consider under a disability for 1 year from the date of the transplant; after that, evaluate the residual impairment(s). 105.10 Need for supplemental daily enteral feeding via a gastrostomy, duodenostomy, or jejunostomy (see 105.00H) due to any cause, for children who have not attained age 3; after that, evaluate the residual impairment(s). 105.11 Small intestine transplantation (see 105.00G). Consider under a disability for 1 year from the date of the transplant; after that, evaluate the residual impairment(s). 105.12 Pancreas transplantation (see 105.00G). Consider under a disability for 1 year from the date of the transplant; after that, evaluate the residual impairment(s). 106.00 Genitourinary Disorders C. * * * 5. * * * b. * * * (iii) BMI is the ratio of a child’s weight to the square of his or her height. We calculate BMI using the formulas in the digestive disorders body system (105.00). * * * * * 108.00 Skin Disorders A. Which skin disorders do we evaluate under these listings? We use these listings to VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 evaluate skin disorders that result from hereditary, congenital, or acquired pathological processes. We evaluate genetic photosensitivity disorders (108.07), burns (108.08), and chronic conditions of the skin or mucous membranes such as ichthyosis, bullous disease, dermatitis, psoriasis, and hidradenitis suppurativa (108.09) under these listings. B. What are our definitions for the following terms used in this body system? 1. Assistive device(s): An assistive device, for the purposes of these listings, is any device used to improve stability, dexterity, or mobility. An assistive device can be handheld, such as a cane(s), a crutch(es), or a walker; used in a seated position, such as a wheelchair, rollator, or power operated vehicle; or worn, such as a prosthesis or an orthosis. 2. Chronic skin lesions: Chronic skin lesions can have recurrent exacerbations (see 108.00B7). They can occur despite prescribed medical treatment. These chronic skin lesions can develop on any part of your body, including upper extremities, lower extremities, palms of your hands, soles of your feet, the perineum, inguinal (groin) region, and axillae (underarms). Chronic skin lesions may result in functional limitations as described in 108.00D2. PO 00000 Frm 00042 Fmt 4701 Sfmt 4700 3. Contractures: Contractures are permanent fibrous scar tissue resulting in tightening and thickening of skin that prevents normal movement of the damaged area. They can develop on any part of your musculoskeletal system, including upper extremities, lower extremities, palms of your hands, soles of your feet, the perineum, inguinal (groin) region, and axillae (underarms). Contractures may result in functional limitations as described in 108.00D2. 4. Documented medical need: When we use the term ‘‘documented medical need,’’ we mean that there is evidence (see § 416.913 of this chapter) from your medical source(s) in the medical record that supports your need for an assistive device (see 108.00B1) for a continuous period of at least 12 months. The evidence must include documentation from your medical source(s) describing any limitation(s) in your upper or lower extremity functioning that supports your need for the assistive device and describing the circumstances for which you need it. The evidence does not have to include a specific prescription for the device. 5. Fine and gross movements: Fine movements, for the purposes of these listings, involve use of your wrists, hands, and fingers; such movements include picking, pinching, manipulating, and fingering. Gross E:\FR\FM\08JNR2.SGM 08JNR2 ddrumheller on DSK120RN23PROD with RULES2 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations movements involve use of your shoulders, upper arms, forearms, and hands; such movements include handling, gripping, grasping, holding, turning, and reaching. Gross movements also include exertional activities such as lifting, carrying, pushing, and pulling. Evaluation of fine and gross movements is dependent on your age. 6. Surgical management: For the purposes of these listings, surgical management includes the surgery(ies) itself, as well as various post-surgical procedures, surgical complications, infections or other medical complications, related illnesses, or related treatments that delay a person’s attainment of maximum benefit from surgery. 7. Exacerbation: For the purposes of these listings, exacerbation means an increase in the signs or symptoms of the skin disorder. Exacerbation may also be referred to as flare, flare-up, or worsening of the skin disorder. C. What evidence do we need to evaluate your skin disorder? 1. To establish the presence of a skin disorder as a medically determinable impairment, we need objective medical evidence from an acceptable medical source (AMS) who has examined you for the disorder. 2. We will make every reasonable effort to obtain your medical history, treatment records, and relevant laboratory findings, but we will not purchase genetic testing. 3. When we evaluate the presence and severity of your skin disorder(s), we generally need information regarding: a. The onset, duration, and frequency of exacerbations (see 108.00B7); b. The prognosis of your skin disorder; c. The location, size, and appearance of lesions and contractures; d. Any available history of familial incidence; e. Your exposure to toxins, allergens or irritants; seasonal variations; and stress factors; f. Your ability to function outside of a highly protective environment (see 108.00E4); g. Laboratory findings (for example, a biopsy obtained independently of Social Security disability evaluation or results of blood tests); h. Evidence from other medically acceptable methods consistent with the prevailing state of medical knowledge and clinical practice; and i. Statements you or others make about your disorder(s), your restrictions, and your daily activities. D. How do we evaluate the severity of skin disorders? 1. General. We evaluate the severity of skin disorders based on the site(s) of your chronic skin lesions (see 108.00B2) or contractures (see 108.00B3), functional limitations caused by your signs and symptoms (including pain) (see 108.00D2), and how your prescribed treatment affects you. We consider the frequency and severity of your exacerbations (see 108.00B7), how quickly they resolve, and how you function between exacerbations (see 108.00B7), to determine whether your skin disorder meets or medically equals a listing (see 108.00D3). If there is no record of ongoing medical treatment for your disorder, we will follow VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 the guidelines in 108.00D6. We will determine the extent and kinds of evidence we need from medical and non-medical sources based on the individual facts about your disorder. For our basic rules on evidence, see §§ 416.912, 416.913, and 416.920b of this chapter. For our rules on evaluating your symptoms, see § 416.929 of this chapter. 2. Limitation(s) of physical functioning due to skin disorders. a. Skin disorders may be due to chronic skin lesions (see 108.00B2) or contractures (see 108.00B3), and may cause pain or restrict movement, which can limit your ability to initiate, sustain, and complete ageappropriate activities. For example, skin lesions in the axilla may limit your ability to raise or reach with the affected arm, or lesions in the inguinal region may limit your ability to ambulate, sit, or lift and carry. To evaluate your skin disorder(s) under 108.07B, 108.08, and 108.09, we require medically documented evidence of physical limitation(s) of functioning related to your disorder. The decrease in physical function must have lasted, or can be expected to last, for a continuous period of at least 12 months (see § 416.909 of this chapter). Xeroderma pigmentosum is the only skin disorder that does not include functional criteria because the characteristics and severity of the disorder itself are sufficient to meet the criteria in 108.07A. b. The functional criteria require impairment-related physical limitations in using upper or lower extremities that have lasted, or can be expected to last, for a continuous period of at least 12 months, medically documented by one of the following: (i) Inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements (see 108.00B5) due to chronic skin lesions (see 108.00B2) or contractures (see 108.00B3); or (ii) Inability to use one upper extremity to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements (see 108.00B5) due to chronic skin lesions (see 108.00B2) or contractures (see 108.00B3), and a documented medical need (see 108.00B4) for an assistive device (see 108.00B1) that requires the use of the other upper extremity; or (iii) Inability to stand up from a seated position and maintain an upright position to the extent needed to independently initiate, sustain, and complete age-appropriate activities due to chronic skin lesions (see 108.00B2) or contractures (see 108.00B3) affecting at least two extremities (including when the limitations are due to involvement of the perineum or the inguinal region); or (iv) Inability to maintain an upright position while standing or walking to the extent needed to independently initiate, sustain, and complete age-appropriate activities due to chronic skin lesions (see 108.00B2) or contractures (see 108.00B3) affecting both lower extremities (including when the limitations are due to involvement of the perineum or the inguinal region). PO 00000 Frm 00043 Fmt 4701 Sfmt 4700 37745 3. Frequency of exacerbations due to chronic skin lesions. A skin disorder resulting in chronic skin lesions (see 108.00B2) may have frequent exacerbations (see 108.00B7) severe enough to meet a listing even if each individual skin lesion exacerbation (see 108.00B7) did not last for an extended amount of time. We will consider the frequency, severity, and duration of skin lesion exacerbations (see 108.00B7), how quickly they resolve, and how you function in the time between skin lesion exacerbations (see 108.00B7), to determine whether your skin disorder meets or medically equals a listing. 4. Symptoms (including pain). Your symptoms may be an important factor in our determination of whether your skin disorder(s) meets or medically equals a listing. We consider your symptoms only when you have a medically determinable impairment(s) that could reasonably be expected to produce the symptoms. See § 416.929 of this chapter. 5. Treatment. a. General. Treatments for skin disorders may have beneficial or adverse effects, and responses to treatment vary from person to person. Your skin disorder’s response to treatment may vary due to treatment resistance or side effects that can result in functional limitations. We will evaluate all of the effects of treatment (including surgical treatment, medications, and therapy) on the symptoms, signs, and laboratory findings of your skin disorder, and on your ability to function. b. Despite adherence to prescribed medical treatment for 3 months. Under 108.09, we require that your symptoms persist ‘‘despite adherence to prescribed medical treatment for 3 months.’’ This requirement means that you must have taken prescribed medication(s) or followed other medical treatment prescribed by a medical source for 3 consecutive months. Treatment or effects of treatment may be temporary. In most cases, sufficient time must elapse to allow us to evaluate your response to treatment, including any side effects. For our purposes, ‘‘sufficient time’’ means a period of at least 3 months. If your treatment has not lasted for at least 3 months, we will follow the rules in 108.00D6a. The 3 months adherence to prescribed medical treatment must be within the period of at least 12 months that we use to evaluate severity. c. Treatment with PUVA (psoralen and ultraviolet A (UVA) light) or biologics. If you receive additional treatment with PUVA or biologics to treat your skin disorder(s), we will defer adjudication of your claim for 6 months from the start of treatment with PUVA or biologics to evaluate the effectiveness of these treatments unless we can make a fully favorable determination or decision on another basis. 6. No record of ongoing treatment. a. Despite having a skin disorder, you may not have received ongoing treatment, may have just begun treatment, may not have access to prescribed medical treatment, or may not have an ongoing relationship with the medical community. In any of these situations, you will not have a longitudinal medical record for us to review when we E:\FR\FM\08JNR2.SGM 08JNR2 ddrumheller on DSK120RN23PROD with RULES2 37746 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations evaluate your disorder. In some instances, we may be able to assess the severity and duration of your skin disorder based on your medical record and current evidence alone. We may ask you to attend a consultative examination to determine the severity and potential duration of your skin disorder (see § 416.919a of this chapter). b. If, for any reason, you have not received treatment, your skin disorder cannot meet the criteria for 108.09. If the information in your case record is not sufficient to show that you have a skin disorder that meets the criteria of one of the skin disorders listings, we will follow the rules in 108.00I. E. How do we evaluate genetic photosensitivity disorders under 108.07? Genetic photosensitivity disorders are disorders of the skin caused by an increase in the sensitivity of the skin to sources of ultraviolet light, including sunlight. 1. Xeroderma pigmentosum (XP) (108.07A). XP is a genetic photosensitivity disorder with lifelong hypersensitivity to all forms of ultraviolet light. Laboratory testing confirms the diagnosis by documenting abnormalities in the body’s ability to repair DNA (deoxyribonucleic acid) mutations after ultraviolet light exposure. Your skin disorder meets the requirements of 108.07A if you have clinical and laboratory findings supporting a diagnosis of XP (see 108.00E3). 2. Other genetic photosensitivity disorders (108.07B). The effects of other genetic photosensitivity disorders may vary and may not persist over time. To meet the requirements of 108.07B, a genetic photosensitivity disorder other than XP must be established by clinical and laboratory findings (see 108.00C) and must result either in chronic skin lesions (see 108.00B2) or contractures (see 108.00B3) that result in functional limitations (108.00D2), or must result in the inability to function outside of a highly protective environment (see 108.00E4). Some genetic photosensitivity disorders can have very serious effects on other body systems, especially special senses and speech, neurological, mental, and cancer. We will evaluate your disorder(s) under the listings in 102.00, 111.00, 112.00, or 113.00, as appropriate. 3. What evidence do we need to document that you have XP or another genetic photosensitivity disorder? We will make a reasonable effort to obtain evidence of your disorder(s), but we will not purchase genetic testing. When the results of genetic tests are part of the existing evidence in your case record, we will evaluate the test results with all other relevant evidence. We need the following clinical and laboratory findings to document that you have XP or another genetic photosensitivity disorder: a. A laboratory report of a definitive genetic test documenting appropriate chromosomal changes, including abnormal DNA repair or another DNA abnormality specific to your type of photosensitivity disorder, signed by an AMS; or b. A laboratory report of a definitive test that is not signed by an AMS, and a report from an AMS stating that you have undergone definitive genetic laboratory studies documenting appropriate chromosomal changes, including abnormal DNA repair or another DNA abnormality VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 specific to your type of photosensitivity disorder; or c. If we do not have a laboratory report of a definitive test, we need documentation from an AMS that an appropriate laboratory analysis or other diagnostic method(s) confirms a positive diagnosis of your skin disorder. This documentation must state that you had the appropriate definitive laboratory test(s) for diagnosing your disorder and provide the results, or explain how another diagnostic method(s), consistent with the prevailing state of medical knowledge and clinical practice, established your diagnosis. 4. Inability to function outside of a highly protective environment means that you must avoid exposure to ultraviolet light (including sunlight passing through windows and light from similar unshielded light sources), wear protective clothing and eyeglasses, and use opaque broad-spectrum sunscreens in order to avoid skin cancer or other serious effects. F. How do we evaluate burns under 108.08? 1. Electrical, chemical, or thermal burns frequently affect other body systems; for example, musculoskeletal, special senses and speech, respiratory, cardiovascular, genitourinary, neurological, or mental. We evaluate burns in the same way we evaluate other disorders that can affect the skin and other body systems, using the listing for the predominant feature of your disorder. For example, if your soft tissue injuries resulting from burns are under surgical management (as defined in 108.00B6), we will evaluate your disorder under the listings in 101.00. 2. We evaluate burns resulting in chronic skin lesions (see 108.00B2) or contractures (see 108.00B3) that have been documented by an AMS to have reached maximum therapeutic benefit and therefore are no longer receiving surgical management, under 108.08. To be disabling, these burns must result in functional limitation(s) (see 108.00D2) that has lasted or can be expected to last for a continuous period of at least 12 months. G. How do we evaluate chronic conditions of the skin or mucous membranes under 108.09? We evaluate skin disorders that result in chronic skin lesions (see 108.00B2) or contractures (see 108.00B3) under 108.09. These disorders must result in chronic skin lesions (see 108.00B2) or contractures (see 108.00B3) that continue to persist despite adherence to prescribed medical treatment for 3 months (see 108.00D5b) and cause functional limitations (see 108.00D2). Examples of skin disorders evaluated under this listing are ichthyosis, bullous diseases (such as pemphigus, epidermolysis bullosa, and dermatitis herpetiformis), chronic skin infections, dermatitis, psoriasis, and hidradenitis suppurativa. H. How do we evaluate disorders in other body systems that affect the skin? When your disorder(s) in another body system affects your skin, we first evaluate the predominant feature of your disorder(s) under the appropriate body system. Examples of disorders in other body systems that affect the skin include the following: 1. Tuberous sclerosis. The predominant functionally limiting features of tuberous sclerosis are seizures and intellectual PO 00000 Frm 00044 Fmt 4701 Sfmt 4700 disorder or other mental disorders. We evaluate these features under the listings in 111.00 or 112.00, as appropriate. 2. Malignant tumors of the skin. Malignant tumors of the skin (for example, malignant melanomas) are cancers, or malignant neoplastic diseases, that we evaluate under the listings in 113.00. 3. Immune system disorders. We evaluate skin manifestations of immune system disorders such as systemic lupus erythematosus, scleroderma, psoriasis, and human immunodeficiency virus (HIV) infection under the listings in 114.00. 4. Head or facial disfigurement or deformity, and other physical deformities caused by skin disorders. A head or facial disfigurement or deformity may result in loss of your sight, hearing, speech, or ability to chew. In addition to head and facial disfigurement and deformity, other physical deformities may result in associated psychological problems (for example, depression). We evaluate the effects of head or facial disfigurement or deformity, or other physical deformities caused by skin disorders under the listings in 101.00, 102.00, 105.00, or 112.00, as appropriate. 5. Porphyria. We evaluate erythropoietic protoporphyria under the listings in 107.00. 6. Hemangiomas. We evaluate hemangiomas associated with thrombocytopenia and hemorrhage (for example, Kasabach-Merritt syndrome) involving coagulation defects under the listings in 107.00. When hemangiomas impinge on vital structures or interfere with functioning, we evaluate their primary effects under the listings in the appropriate body system. I. How do we evaluate skin disorders that do not meet one of these listings? 1. These listings are only examples of common skin disorders that we consider severe enough to result in marked and severe limitations. If your impairment(s) does not meet the criteria of any of these listings, we must also consider whether you have an impairment(s) that satisfies the criteria of a listing in another body system. 2. If you have a severe medically determinable impairment(s) that does not meet a listing, we will determine whether your impairment(s) medically equals a listing. See § 416.926 of this chapter. If your impairment(s) does not meet or medically equal a listing, we will also consider whether your impairment(s) functionally equals the listings. See § 416.926a of this chapter. We use the rules in § 416.994a of this chapter when we decide whether you continue to be disabled. 108.01 Category of Impairments, Skin Disorders 108.02–108.06 [Reserved] 108.07 Genetic photosensitivity disorders, established as described in 108.00E. The requirements of this listing are met if either paragraph A or paragraph B is satisfied. A. Xeroderma pigmentosum (see 108.00E1). OR B. Other genetic photosensitivity disorders (see 108.00E2) with either 1 or 2: 1. Chronic skin lesions (see 108.00B2) or contractures (see 108.00B3) that cause an E:\FR\FM\08JNR2.SGM 08JNR2 Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Rules and Regulations ddrumheller on DSK120RN23PROD with RULES2 inability to function outside of a highly protective environment (see 108.00E4); or 2. Chronic skin lesions (see 108.00B2) or contractures (see 108.00B3) causing chronic pain or other physical limitation(s) that result in impairment-related functional limitations (see 108.00D2), as evidenced by: a. Inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements (see 108.00B5) due to chronic skin lesions (see 108.00B2) or contractures (see 108.00B3); or b. Inability to use one upper extremity to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements (see 108.00B5) due to chronic skin lesions (see 108.00B2) or contractures (see 108.00B3), and a documented medical need (see 108.00B4) for an assistive device (see 108.00B1) that requires the use of the other upper extremity; or c. Inability to stand up from a seated position and maintain an upright position to the extent needed to independently initiate, sustain, and complete age-appropriate activities due to chronic skin lesions (see 108.00B2) or contractures (see 108.00B3) affecting at least two extremities (including when the limitations are due to involvement of the perineum or the inguinal region); or d. Inability to maintain an upright position while standing or walking to the extent needed to independently initiate, sustain, and complete age-appropriate activities due to chronic skin lesions (see 108.00B2) or contractures (see 108.00B3) affecting both lower extremities (including when the limitations are due to involvement of the perineum or the inguinal region). 108.08 Burns (see 108.00F). Burns that do not require continuing surgical management (see 108.00B6), or that have been documented by an acceptable medical source to have reached maximum therapeutic benefit and are no longer receiving surgical management, resulting in chronic skin lesions (see 108.00B2) or contractures (see 108.00B3) causing chronic pain or other physical limitation(s) that result in impairment-related functional limitations (see 108.00D2), as evidenced by: VerDate Sep<11>2014 18:50 Jun 07, 2023 Jkt 259001 A. Inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements (see 108.00B5) due to chronic skin lesions (see 108.00B2) or contractures (see 108.00B3). OR B. Inability to use one upper extremity to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements (see 108.00B5) due to chronic skin lesions (see 108.00B2) or contractures (see 108.00B3), and a documented medical need (see 108.00B4) for an assistive device (see 108.00B1) that requires the use of the other upper extremity. OR C. Inability to stand up from a seated position and maintain an upright position to the extent needed to independently initiate, sustain, and complete age-appropriate activities due to chronic skin lesions (see 108.00B2) or contractures (see 108.00B3) affecting at least two extremities (including when the limitations are due to involvement of the perineum or the inguinal region). OR D. Inability to maintain an upright position while standing or walking to the extent needed to independently initiate, sustain, and complete age-appropriate activities due to chronic skin lesions (see 108.00B2) or contractures (see 108.00B3) affecting both lower extremities (including when the limitations are due to involvement of the perineum or the inguinal region). 108.09 Chronic conditions of the skin or mucous membranes (see 108.00G) resulting in: A. Chronic skin lesions (see 108.00B2) or contractures (see 108.00B3) causing chronic pain or other physical limitation(s) that persist despite adherence to prescribed medical treatment for 3 months (see 108.00D5b). AND B. Impairment-related functional limitations (see 108.00D2) demonstrated by 1, 2, 3, or 4: PO 00000 Frm 00045 Fmt 4701 Sfmt 9990 37747 1. Inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements (see 108.00B5) due to chronic skin lesions (see 108.00B2) or contractures (see 108.00B3); or 2. Inability to use one upper extremity to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements (see 108.00B5) due to chronic skin lesions (see 108.00B2) or contractures (see 108.00B3), and a documented medical need (see 108.00B4) for an assistive device (see 108.00B1) that requires the use of the other upper extremity; or 3. Inability to stand up from a seated position and maintain an upright position to the extent needed to independently initiate, sustain, and complete age-appropriate activities due to chronic skin lesions (see 108.00B2) or contractures (see 108.00B3) affecting at least two extremities (including when the limitations are due to involvement of the perineum or the inguinal region); or 4. Inability to maintain an upright position while standing or walking to the extent needed to independently initiate, sustain, and complete age-appropriate activities due to chronic skin lesions (see 108.00B2) or contractures (see 108.00B3) affecting both lower extremities (including when the limitations are due to involvement of the perineum or the inguinal region). * * 114.00 * * * * Immune System Disorders * * * * F. * * * 7. * * * b. * * * (iii) BMI is the ratio of a child’s weight to the square of his or her height. We calculate BMI using the formulas in the digestive disorders body system (105.00). * * * * * [FR Doc. 2023–11771 Filed 6–7–23; 8:45 am] BILLING CODE 4191–02–P E:\FR\FM\08JNR2.SGM 08JNR2

Agencies

Social Security Administration

[Federal Register Volume 88, Number 110 (Thursday, June 8, 2023)]
[Rules and Regulations]
[Pages 37704-37747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11771]

[[Page 37703]]

Vol. 88

Thursday,

No. 110

June 8, 2023

Part III

Social Security Administration

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20 CFR Parts 404 and 416

Revised Medical Criteria for Evaluating Digestive Disorders and Skin
Disorders; Final Rule

Federal Register / Vol. 88 , No. 110 / Thursday, June 8, 2023 / Rules
and Regulations

[[Page 37704]]

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SOCIAL SECURITY ADMINISTRATION

20 CFR Parts 404 and 416

[Docket No. SSA-2017-0042]
RIN 0960-AG65

Revised Medical Criteria for Evaluating Digestive Disorders and
Skin Disorders

AGENCY: Social Security Administration.

ACTION: Final rule.

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SUMMARY: We are revising the criteria in the Listing of Impairments
(listings) that we use to evaluate claims involving digestive disorders
and skin disorders in adults and children under titles II and XVI of
the Social Security Act (Act). The revisions reflect our adjudicative
experience, advances in medical knowledge, and comments we received
from the public in response to a notice of proposed rulemaking (NPRM).

DATES: This rule is effective October 6, 2023.

FOR FURTHER INFORMATION CONTACT: Michael J. Goldstein, Office of
Disability Policy, Social Security Administration, 6401 Security
Boulevard, Baltimore, Maryland 21235-6401, (410) 965-1020.
For information on eligibility or filing for benefits, call our
national toll-free number, 1-800-772-1213, or TTY 1-800-325-0778, or
visit our internet site, Social Security Online, at https://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.
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\1\ 20 CFR 404.1525(a) and 416.925(a).
\2\ 20 CFR 416.925(a).
\3\ 20 CFR 404.1520, 416.920, and 416.924.
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We last published final rules that revised the digestive disorders
listings on October 19, 2007, and the skin disorders listings on June
9, 2004.\4\ We published an Advance Notice of Proposed Rulemaking
(ANPRM) for digestive disorders in the Federal Register on December 12,
2007.\5\ We published an ANPRM for skin disorders in the Federal
Register on November 10, 2009.\6\
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\4\ 72 FR 59398 (2007) and 69 FR 32260 (2004).
\5\ 72 FR 70527 (2007).
\6\ 74 FR 57972 (2009), with the docket number corrected at 74
FR 62518 (2009).
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We are making final the rule for evaluating digestive disorders and
skin disorders that we proposed in the NPRM published in the Federal
Register on July 25, 2019.\7\ The preamble to the NPRM provides the
background for these revisions. You can view the preamble to the NPRM
by visiting https://www.regulations.gov and searching for document
``SSA-2017-0042.'' There are differences from the NPRM to this final
rule in response to public comments to the NPRM, which we explain
below.
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\7\ 84 FR 35936 (2019).
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Why are we revising the listings for evaluating digestive disorders and
skin disorders?

We developed this final rule as part of our ongoing review of the
listings. We are revising the listings for evaluating digestive
disorders and skin disorders to update their medical criteria, and to
clarify how we evaluate digestive disorders and skin disorders.

When will we begin to use this final rule?

As we noted in the dates section of this preamble, this final rule
will be effective on October 6, 2023. We delayed the effective date of
the rule to give us time to update our systems and to provide training
and guidance to all of our adjudicators before we implement the final
rule. The current rules will continue to apply until the effective date
of the final rule. When the final rule becomes effective, we will apply
it to new applications filed on or after the effective date of the
rule, and to claims that are pending on or after the effective date.\8\
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\8\ This means that we will use this final rule on and after the
effective date in any case in which we make a determination or
decision. We expect that Federal courts will review our final
decisions using the rules that were in effect at the time we issued
the decisions. If a court reverses our final decision and remands a
case for further administrative proceedings after the effective date
of this final rule, we will apply this final rule to the entire
period at issue in the decision we make after the court's remand.
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We present a series of tables below. These tables summarize
revisions we made to the digestive disorders and skin disorders
introductory text and listings. Following the tables, we discuss the
changes in detail.

Digestive Disorders

The following table summarizes the current and revised sections of
the adult digestive disorders introductory text and listings:

------------------------------------------------------------------------
Sections of the Adult
Introductory Text and Listings Revised sections of the Adult
for the digestive system prior to Introductory Text and Listings for
the effective date of this Final digestive disorders
Rule
------------------------------------------------------------------------
Introductory Text, 5.00
------------------------------------------------------------------------
A. What kinds of disorders do we A. Which digestive disorders do we
consider in the digestive evaluate in this body system?
system?.
B. What documentation do we need? B. What evidence do we need to
evaluate your digestive disorder?
C. How do we consider the effects [5.00 H.]
of treatment?.
D. How do we evaluate chronic C. What is chronic liver disease
liver disease?. (CLD), and how do we evaluate it
under 5.05?
E. How do we evaluate D. What is inflammatory bowel disease
inflammatory bowel disease (IBD), and how do we evaluate it
(IBD)?. under 5.06?
F. How do we evaluate short bowel E. What is intestinal failure and how
syndrome (SBS)?. do we evaluate it under 5.07?
G. How do we evaluate weight loss F. How do we evaluate weight loss due
due to any digestive disorder?. to any digestive disorder under
5.08?
[5.00 D.12.]..................... G. How do we evaluate digestive organ
transplantation?
H. What do we mean by the phrase [5.00 C.2. and G.]
``consider under a disability
for 1 year''?.
[5.00 C.6.]...................... H. How do we evaluate your digestive
disorder if there is no record of
ongoing treatment?
I. How do we evaluate your digestive
disorder if there is evidence
establishing a substance use
disorder?
I. How do we evaluate impairments J. How do we evaluate digestive
that do not meet one of the disorders that do not meet one of
digestive disorder listings? these listings?

[[Page 37705]]

Listings
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5.01 Category of Impairments, 5.01 Category of Impairments,
Digestive System. Digestive Disorders
5.02 Gastrointestinal 5.02 Gastrointestinal hemorrhaging
hemorrhaging from any cause, from any cause, requiring three
requiring blood transfusion. blood transfusions
5.03 [Reserved].................. 5.03 [Reserved]
5.04 [Reserved].................. 5.04 [Reserved]
5.05 Chronic liver disease (CLD). 5.05 Chronic liver disease (CLD)
5.06 Inflammatory bowel disease 5.06 Inflammatory bowel disease (IBD)
(IBD).
5.07 Short bowel syndrome (SBS).. 5.07 Intestinal failure
5.08 Weight loss due to any 5.08 Weight loss due to any digestive
digestive disorder. disorder
5.09 Liver transplantation....... 5.09 Liver transplantation
5.10 [Reserved]
5.11 Small intestine transplantation
5.12 Pancreas transplantation
------------------------------------------------------------------------

The following table summarizes the current and revised sections of
the childhood digestive disorders introductory text and listings:

------------------------------------------------------------------------
Sections of the Childhood
Introductory Text and listings Revised sections of the Childhood
for the digestive system prior to Introductory Text and listings for
the effective date of this final digestive disorders
rule
------------------------------------------------------------------------
Introductory Text, 105.00
------------------------------------------------------------------------
A. What kinds of disorders do we A. Which digestive disorders do we
consider in the digestive evaluate in this body system?
system?.
B. What documentation do we need? B. What evidence do we need to
evaluate your digestive disorder?
C. How do we consider the effects [105.00 J.]
of treatment?.
D. How do we evaluate chronic C. What is chronic liver disease
liver disease?. (CLD), and how do we evaluate it
under 105.05?
E. How do we evaluate D. What is inflammatory bowel disease
inflammatory bowel disease (IBD), and how do we evaluate it
(IBD)?. under 105.06?
F. How do we evaluate short bowel E. What is intestinal failure, and
syndrome (SBS)?. how do we evaluate it under 105.07?
G. How do we evaluate growth F. How do we evaluate growth failure
failure due to any digestive due to any digestive disorder under
disorder?. 105.08?
[105.00 D.13.]................... G. How do we evaluate digestive organ
transplantation?
H. How do we evaluate the need H. How do we evaluate the need for
for supplemental daily enteral supplemental daily enteral feeding
feeding via a gastrostomy? via a gastrostomy, duodenostomy, or
jejunostomy?
I. How do we evaluate esophageal I. How do we evaluate esophageal
stricture or stenosis?. stricture or stenosis?
J. What do we mean by the phrase [105.00 C.2., C.4., and G.]
``consider under a disability
for 1 year''?.
[105.00 C.6.].................... J. How do we evaluate your digestive
disorder if there is no record of
ongoing treatment?
K. How do we evaluate your digestive
disorder if there is evidence
establishing a substance use
disorder?
K. How do we evaluate impairments L. How do we evaluate digestive
that do not meet one of the disorders that do not meet one of
digestive disorder listings? these listings?
------------------------------------------------------------------------
Listings
------------------------------------------------------------------------
105.01 Category of Impairments, 105.01 Category of Impairments,
Digestive System. Digestive Disorders
105.02 Gastrointestinal 105.02 Gastrointestinal hemorrhaging
hemorrhaging from any cause, from any cause, requiring three
requiring blood transfusion. blood transfusions
105.03 [Reserved]................ 105.03 [Reserved]
105.04 [Reserved]................ 105.04 [Reserved]
105.05 Chronic liver disease..... 105.05 Chronic liver disease (CLD)
105.06 Inflammatory bowel disease 105.06 Inflammatory bowel disease
(IBD). (IBD)
105.07 Short bowel syndrome (SBS) 105.07 Intestinal failure
105.08 Growth failure due to any 105.08 Growth failure due to any
digestive disorder. digestive disorder
105.09 Liver transplantation..... 105.09 Liver transplantation
105.10 Need for supplemental 105.10 Need for supplemental daily
daily enteral feeding via a enteral feeding via a gastrostomy,
gastrostomy. duodenostomy, or jejunostomy
105.11 Small intestine
transplantation
105.12 Pancreas transplantation
------------------------------------------------------------------------

The following table shows our changes to the adult and childhood
digestive disorders listings criteria that involve changes to
healthcare utilization and condition/episode requirements, the
rationale for each change, and supporting resources. The table first
summarizes the policy changes that apply to multiple adult and
childhood digestive disorders listings and then focuses on changes in
specific listings.

[[Page 37706]]

Adult and Childhood Digestive Disorders Listing Criteria Change in Healthcare Utilization That Applies to
Multiple Listings: Change to 12-Month Timeframe in Listing Criteria Requiring Documentation of Findings on Two
or More Occasions
----------------------------------------------------------------------------------------------------------------
Introductory text or listing criteria
prior to the effective date of this Revised listing Rationale Resources
final rule criteria
----------------------------------------------------------------------------------------------------------------
5.02/105.02 Gastrointestinal 5.02/105.02 The revised text is Section 223(d)(1)(A) of
hemorrhaging from any cause, Gastrointestinal more consistent with the Social Security
requiring blood transfusion (with or hemorrhaging from any our statutory Act.
without hospitalization) of at least cause, requiring three definition of
2 units of blood per transfusion (or blood transfusions of disability; that is,
at least 10 cc of blood/kg of body at least 2 units of the inability to do
weight per transfusion for blood per transfusion, any substantial
children), and occurring at least or at least 10 cc of gainful activity by
three times during a consecutive 6- blood/kg of body reason of any
month-period. The transfusions must weight per medically determinable
be at least 30 days apart within the transfusion, within a physical or mental
6-month period. consecutive 12-month impairment which can
period and at least 30 be expected to result
days apart. in death or which has
lasted or can be
expected to last for a
continuous period of
not less than 12
months.
5.05B/105.05B Chronic liver disease, 5.05B/105.05B Chronic
with: liver disease (CLD)
Ascites or hydrothorax not (see 5.00C) with A, B,
attributable to other causes, C, D, E, F, or G:
despite continuing treatment as Ascites or hydrothorax
prescribed, present on at least 2 not attributable to
evaluations at least 60 days apart other causes (see
within a consecutive 6-month period. 5.00C2b and
Each evaluation must be documented 105.00C2b), present on
by:. two evaluations within
a consecutive 12-month
period and at least 60
days apart. Each
evaluation must
document the ascites
or hydrothorax by 1,
2, or 3:.
5.05F/105.05F Chronic liver disease, 5.05F/105.05F Chronic
with: liver disease (CLD)
Hepatic encephalopathy as described (see 5.00C) with A, B,
in 5.00D10, with 1 and either 2 or C, D, E, F, or G:
3:. Hepatic encephalopathy
1. Documentation of abnormal (see 5.00C2f and
behavior, cognitive dysfunction, 105.00C2f) with
changes in mental status, or altered documentation of
state of consciousness (for example, abnormal behavior,
confusion, delirium, stupor, or cognitive dysfunction,
coma), present on at least two changes in mental
evaluations at least 60 days apart status, or altered
within a consecutive 6-month period;. state of consciousness
3. One of the following occurring on (for example,
at least two evaluations at least 60 confusion, delirium,
days apart within the same stupor, or coma),
consecutive 6-month period as in F1:. present on two
evaluations within a
consecutive 12-month
period and at least 60
days apart and either
1 or 2:.
2. One of the following
on at least two
evaluations at least
60 days apart within
the same consecutive
12-month period as in
F:.
5.05G/105.05G End stage liver disease 5.05G/105.05G Two SSA
with SSA CLD scores of 22 or greater CLD scores (see
calculated as described in 5.00D11. 5.00C3) of at least 20
within a consecutive
12-month period and at
least 60 days apart.
5.06/105.06 Inflammatory bowel 5.06/105.06
disease (IBD) documented by Inflammatory bowel
endoscopy, biopsy, appropriate disease (IBD) (see
medically acceptable imaging, or 5.00D/105.00D)
operative findings with: documented by
A. Obstruction of stenotic areas (not endoscopy, biopsy,
adhesions) in the small intestine or imaging, or operative
colon with proximal dilatation, findings, and
confirmed by appropriate medically demonstrated by A, B,
acceptable imaging or in surgery, or C:
requiring hospitalization for A. Obstruction of
intestinal decompression or for stenotic areas (not
surgery, and occurring on at least adhesions) in the
two occasions at least 60 days apart small intestine or
within a consecutive 6-month period;. colon with proximal
OR................................... dilatation, confirmed
B. Two of the following despite by imaging or in
continuing treatment as prescribed surgery, requiring two
and occurring within the same hospitalizations for
consecutive 6-month period:. intestinal
decompression or for
surgery, within a
consecutive 12-month
period and at least 60
days apart..
OR.....................
B. Two of the following
occurring within a
consecutive 12-month
period and at least 60
days apart:.
5.08 Weight loss due to any digestive 5.08 Weight loss due to
disorder despite continuing any digestive disorder
treatment as prescribed, with body (see 5.00F), despite
mass index (BMI) of less than 17.50 adherence to
calculated on at least two prescribed medical
evaluations at least 60 days apart treatment, with BMI of
within a consecutive 6-month period. less than 17.50
calculated on at least
two evaluations at
least 60 days apart
within a consecutive
12-month period.
----------------------------------------------------------------------------------------------------------------

[[Page 37707]]

Adult and Childhood Digestive Disorders Listings Criteria--Changes in
Healthcare Utilization Introductory Text--5.00/105.00
------------------------------------------------------------------------
Introductory Text
or Listing Revised
Criteria Prior to Introductory Text
the Effective or Listing Rationale Resources
Date of This Criteria
Final Rule
------------------------------------------------------------------------
5.00D/105.00D 5.00/105.00C The revised Organ
(How do we (What is chronic introductory Procurement
evaluate chronic liver disease text adds serum and
liver disease) (CLD) and how do sodium, to be Transplantatio
11. End stage we evaluate it?) considered under n Network &
liver disease 3. SSA Chronic certain United Network
(ESLD) Liver Disease conditions, in for Organ
documented by (SSA CLD) score the CLD formula. Sharing.
scores from the (5.05G/105.05G The Model for (2015).
SSA Chronic \9\). Listing End-Stage Liver Changes to
Liver Disease 5.05G requires Disease (MELD) OPTN bylaws
(SSA CLD) two SSA CLD formula, from and policies
calculation scores, each which the CLD from actions
(5.05G/ requiring three formula is based at OPTN/UNOS
105.05G1). or four and is the Executive
b. To calculate laboratory mathematical Committee
the SSA CLD values. The equivalent to, meetings July
score, we use a ``date of the was updated in 2015-November
formula that SSA CLD score'' 2016 to add the 2015 [PDF].
includes three is the date of serum sodium https://
laboratory the earliest of levels. We added optn.transplan
values: Serum the three or serum sodium t.hrsa.gov/
total bilirubin four laboratory levels because, media/1575/
(mg/dL), serum values used for for individuals policynotice_2
creatinine (mg/ its calculation. with certain 0151101.pdf.
dL), and The date of the liver conditions Vaa, B.E.,
International second SSA CLD such as Asrani, S.K.,
Normalized Ratio score must be at alcoholic Dunn, W.,
(INR). least 60 days hepatitis and Kamath, P.S.,
after the date cirrhosis, & Shah, V.H.
of the first SSA medical research (2011).
CLD score and shows serum Influence of
both scores must sodium levels serum sodium
be within the predict negative on MELD-based
required 12- outcomes more survival
month period. If accurately than prediction in
you have the two formulas without alcoholic
SSA CLD scores it. hepatitis.
required by Mayo Clinic
5.05G, we will Proceedings,
find that your 86(1), 37-42.
impairment meets Londo[ntilde]o,
the criteria of M.-C.,
the listing from C[aacute]rdena
at least the s, A.,
date of the Guevara, M.,
first SSA CLD Quint[oacute],
score. L., de las
a. We calculate Heras, D.,
the SSA CLD Navasa, M.,
score using a Rimola, A.,
formula that Garcia-
includes up to Valdecasas, J.-
four laboratory C., Arroya,
values: Serum V., &
creatinine (mg/ Gin[egrave]s,
dL), total P. (2007).
bilirubin (mg/ MELD score and
dL), INR, and serum sodium
under certain in the
conditions, prediction of
serum sodium survival of
(mmol/L). The patients with
SSA CLD score cirrhosis
calculation awaiting liver
contains at transplantatio
least one, and n. Gut, 56(9),
sometimes two, 1283-1290.
parts, as https://
described in (i) doi.org/
and (ii). 10.1136/
gut.2006.10276
4.
------------------------------------------------------------------------
Listing 5.05/105.05 Chronic Liver Disease (CLD)
------------------------------------------------------------------------
5.05G/105.05G End 5.05G/105.05G Two The revised Annamalai, A.,
stage liver SSA CLD scores listing reduces Harada, M.,
disease with SSA (see 5.00C3) of the current Chen, M.,
CLD scores of 22 at least 20 listing level Tran, T., Ko,
or greater within a end stage liver A., Ley, E., .
calculated as consecutive 12- disease CLD . . Noureddin,
described in month period and score of 22 to M. (2016).
5.00D11. at least 60 days 20. Two scores Predictors of
apart. of at least 20 mortality in
accurately the critically
identify ill cirrhotic
advanced, end patient: Is
stage liver the model for
disease that end-stage
prevents a liver disease
person from enough?
working and, Journal of the
without a liver American
transplant, will College of
ultimately Surgeons,
result in death. 224(3), 276-
The unchanged 282. https://
requirement of a doi.org/
second score at 10.1016/
least 60 days j.jamcollsurg.
after the first 2016.11.005.
score is to Zhiang, E.,
confirm Zhang, Z.,
chronicity, Want, S.,
which is Xiao, Z., Gu,
critical for J., Xiong, M.,
confirming . . . Huang,
continued Z. (2016).
severity. We Predicting the
have also severity of
modified this liver
score for cirrhosis
children above through
the age of 12 in clinical
the childhood parameters.
listing (see Journal of
105.05G2). Surgical
Research,
204(2), 274-
281. https://doi.org/10.1016/j.jss.2016.04.036 036.
Singal, A.K. &
Kamath, P.S.
(2013). Model
for end-stage
liver disease.
Journal of
Clinical and
Experimental
Hepatology,
3(1), 50-60.
https://doi.org/10.1016/j.jceh.2012.11.002.
Bittermann, T.,
Makar, G., &
Goldberg, D.S.
(2015). Early
post-
transplant
survival:
Interaction of
MELD score and
hospitalizatio
n status.
Journal of
Hepatology,
63(3), 601-
608. https://www.sciencedirect.com/science/article/pii/S0168827815002445?via%3Dihub
.
------------------------------------------------------------------------

[[Page 37708]]

Listing 5.06/105.06 Inflammatory Bowel Disease (IBD)
------------------------------------------------------------------------
5.06B/105.06B 5.06B/105.06B The revised 20 CFR 404.1530
Inflammatory Inflammatory listing text and 416.930.
bowel disease bowel disease removes the Need to follow
(IBD) documented (IBD) (see 5.00D requirement that prescribed
by endoscopy, and 105.00D) pain not be treatment.
biopsy, documented by completely SSR 18-3p:
appropriate endoscopy, controlled by Titles II and
medically biopsy, imaging, prescribed XVI: Failure
acceptable or operative narcotic to Follow
imaging, or findings, and medication. If a Prescribed
operative demonstrated by person is Treatment.
findings with: A, B, or C: prescribed any
Two of the Two of the medication,
following following including opioid
despite occurring within or other
continuing a consecutive 12- narcotic
treatment as month period and medication, and
prescribed and at least 60 days chooses to not
occurring within apart: take the
the same 3. Clinically medication, we
consecutive 6- documented use our rules
month period: tender abdominal regarding the
3. Clinically mass palpable on need to follow
documented physical prescribed
tender abdominal examination with treatment, which
mass palpable on abdominal pain apply to all
physical or cramping; or medical
examination with 4. Perianal conditions, not
abdominal pain disease with a just digestive
or cramping that draining abscess disorders. In
is not or fistula; or subregulatory
completely policy, we also
controlled by include the
prescribed ``risk of
narcotic addiction to
medication, opioid
present on at medication'' as
least two an example of a
evaluations at ``good cause''
least 60 days reason for not
apart; or following
4. Perineal prescribed
disease with a treatment.''
draining abscess Since it is
or fistula, with already our
pain that is not policy that a
completely lack of, or
controlled by reduction of,
prescribed opioid or
narcotic narcotic
medication, prescriptions
present on at due to the risk
least two of addiction
evaluations at will not
least 60 days adversely affect
apart; or a person's claim
during the
adjudication
process, we
removed
consideration of
narcotic
medication from
these listings.
5.06B/105.06B 5.06B/105.06B The revised Public comment:
Inflammatory Inflammatory listing expands https://
bowel disease bowel disease the alternative www.regulation
(IBD) documented (IBD) (see 5.00D method of s.gov/comment/
by endoscopy, and 105.00D) supplemental SSA-2017-0042-
biopsy, documented by daily enteral 0008.
appropriate endoscopy, nutrition to Pearce, C.B. &
medically biopsy, imaging, meet the listing Duncan, H.D.
acceptable or operative to include (2002).
imaging, or findings, and duodenostomy and Enteral
operative demonstrated by jejunostomy. We feeding.
findings with: A, B, or C: added these two Nasogastric,
6 (5 for 5. Need for additional nasojejunal,
childhood). Need supplemental methods of tube percutaneous
for supplemental daily enteral feeding after we endoscopic
daily enteral nutrition via a received public gastrostomy,
nutrition via a gastrostomy, comment or
gastrostomy or duodenostomy, or requesting that jejunostomy:
daily parenteral jejunostomy, or we expand tube its
nutrition via a daily parenteral feedings to indications
central venous nutrition via a those beyond and
catheter. central venous gastric which limitations,
catheter. are often Postgraduate
required in Medical
patients with Journal, 78,
digestive 198-204.
disorders. https://doi.10.1136/pmj.78.918.198
.
Brett, K. &
Arg[aacute]ez,
C. (2018).
Gastrostomy
versus
gastrojejunost
omy and/or
jejunostomy
feeding tubes:
a review of
clinical
effectiveness,
cost-
effectiveness
and
guidelines.
Ottawa (ON):
Canadian
Agency for
Drugs and
Technologies
in Health.
Clinical
Nutrition
University.
(2021, May
25). Types of
Feeding Tubes
EXPLAINED.
YouTube.
https://www.youtube.com/watch?v=4Oam1yUHiO8 UHiO8.

[[Page 37709]]

No current 5.06C Repeated The revised Farraye, F.A.,
listing criteria complications of listing combines Melmed, G.Y.,
IBD (see required medical Lichtenstein,
5.00D5a), findings with G.R., & Kane,
occurring an specific S.V. (2017).
average of three limitations in ACG clinical
times a year, or functioning to guidelines:
once every 4 identify IBD of Preventative
months, each listing-level care in
lasting 2 weeks severity. inflammatory
or more, within Specifically, bowel disease.
a consecutive 12- the revised American
month period, listing adds a Journal of
and marked criterion for Gastroenterolo
limitation (see repeated gy, 112(2),
5.00D5c) in one complications of 241-258.
of the IBD that result Gajendran, M.,
following: in marked Loganathan,
1. Activities of limitation in at P., Catinella,
daily living least one area A.P., &
(see 5.00D5d); of functioning. Hashash, J.G.
or This combination (2018). A
2. Maintaining of findings comprehensive
social accurately review and
functioning (see characterizes update on
5.00D5e); or complications of Crohn's
3. Completing IBD that prevent disease.
tasks in a a person from Disease-a-
timely manner engaging in any Month, 64, 20-
due to gainful 57.
deficiencies in activity. Rubin, D.T.,
concentration, The addition of Ananthakrishna
persistence, or functional n, A.N.,
pace (see criteria is also Siegel, C.A.,
5.00D5f). consistent with Sauer, B.G., &
the listings Long, M.D.
that already (2019). ACG
include these clinical
same functional guidelines:
criteria, which Ulcerative
are 7.18 colitis in
(Repeated adults.
complications of American
hematological Journal of
disorders), Gastroenterolo
14.02B (Repeated gy, 114(3),
manifestations 384-413.
of systemic Yarur, A.J.,
lupus Strobel, S.G.,
erythematosus), Deshpande,
14.04D (Repeated A.R., & Abreu,
manifestations M.T. (2011).
of systemic Predictors of
sclerosis), aggressive
14.05E (Repeated inflammatory
manifestations bowel disease.
of polymyositis Gastroenterolo
or gy &
dermatomyositis) Hepatology,
, 14.06B 7(10), 652-
(Repeated 659.
manifestations
of
undifferentiated
or mixed
connective
tissue disease),
14.07C (Repeated
manifestations
of an immune
deficiency
disorder),
14.09D (Repeated
manifestations
of inflammatory
arthritis),
14.10B
(Sj[ouml]gren's
syndrome), and
14.11I (Repeated
manifestations
of HIV
infection).
------------------------------------------------------------------------
Listing 5.07/105.07 Intestinal Failure
------------------------------------------------------------------------
5.07/105.07 Short 5.07/105.07 The revised Public comment:
bowel syndrome Intestinal listing more https://
(SBS), due to failure (see broadly www.regulation
surgical 5.00E) due to addresses s.gov/comment/
resection of short bowel intestinal SSA-2017-0042-
more than one- syndrome, failure with 0015.
half of the chronic motility need for Thompson J.S.,
small intestine, disorders, or parenteral Rochling FA,
with dependence extensive small nutrition and Weseman R.A.,
on daily bowel mucosal covers a greater Mercer D.F.
parenteral disease, range of chronic Current
nutrition via a resulting in dysmotility or management of
central venous dependence on absent motility short bowel
catheter (see daily parenteral disorders. We syndrome. Curr
5.00F). nutrition via a adopted a public Probl Surg
central venous comment 49:52-115,
catheter for at requesting this 2012. https://
least 12 months. change to doi.org/
account for 10.1067/
individuals who j.cpsurg.2011.
have intestinal 10.002.
conditions that Pironi, L.,
may exist Arends, J.,
without the Baxter, J.,
surgery Bozzetti, F.,
requirement of Pel[aacute]ez,
short bowel R.B., Cuerda,
syndrome (the C., Forbes,
current A., Gabe, S.,
listing). Gillanders,
L., Holst, M.,
Jeppesen,
P.B., Joly,
F., Kelly, D.,
Klek, S.,
Irtun,
[Oslash].,
Olde Damink,
S.W., Panisic,
M., Rasmussen,
H.H., Staun,
M.,
Szczepanek,
K., . . .
Acute
Intestinal
Failure
Special
Interest
Groups of
ESPEN (2015).
ESPEN endorsed
recommendation
s. Definition
and
classification
of intestinal
failure in
adults.
Clinical
nutrition
(Edinburgh,
Scotland),
34(2), 171-
180. https://doi.org/10.1016/j.clnu.2014.08.017.

[[Page 37710]]

Pironi, L.,
Arends, J.,
Bozzetti, F.,
Cuerda, C.,
Gillanders,
L., Jeppesen,
P.B., Joly,
F., Kelly, D.,
Lal, S.,
Staun, M.,
Szczepanek,
K., Van
Gossum, A.,
Wanten, G.,
Schneider,
S.M., & Home
Artificial
Nutrition &
Chronic
Intestinal
Failure
Special
Interest Group
of ESPEN
(2016). ESPEN
guidelines on
chronic
intestinal
failure in
adults.
Clinical
nutrition
(Edinburgh,
Scotland),
35(2), 247-
307. https://doi.org/10.1016/j.clnu.2016.01.020.
Deutsch, L.,
Cloutier, A.,
& Lal, S.
(2020).
Advances in
chronic
intestinal
failure
management and
therapies.
Current
opinion in
gastroenterolo
gy, 36(3), 223-
229. https://doi.org/10.1097/MOG.0000000000000631 000631.
Pierret, A.,
Wilkinson,
J.T.,
Zilbauer, M.,
& Mann, J.P.
(2019).
Clinical
outcomes in
pediatric
intestinal
failure: a
meta-analysis
and meta-
regression.
The American
journal of
clinical
nutrition,
110(2), 430-
436. https://doi.org/10.1093/ajcn/nqz110 nqz110.
------------------------------------------------------------------------
Listing 105.10 Need for supplemental daily enteral feeding via a
gastrostomy, duodenostomy, or jejunostomy
------------------------------------------------------------------------
105.10 Need for 105.10 Need for The revised Public comment:
supplemental supplemental listing expands https://
daily enteral daily enteral the alternative www.regulation
feeding via a feeding via a method of s.gov/comment/
gastrostomy due gastrostomy, supplemental SSA-2017-0042-
to any cause, duodenostomy, or daily enteral 0008.
for children who jejunostomy (see nutrition to
have not 105.00H) due to meet the listing
attained age 3; any cause, for to include
thereafter, children who duodenostomy and
evaluate the have not jejunostomy. We
residual attained age 3; added these two
impairment(s) after that, additional
(see 105.00H). evaluate the methods of tube
residual feeding after we
impairment(s). received public
comment
requesting that
we expand tube
feedings to
those beyond
gastric which
are often
required in
patients with
digestive
disorders.
------------------------------------------------------------------------

Skin Disorders

The following table summarizes the current and revised sections of
the adult skin disorders introductory text and listings.
---------------------------------------------------------------------------

\9\ The childhood digestive disorders listing includes SSA CLD-P
scores (see 105.00C3). We are not proposing changes to the SSA CLD-P
formula. This table discusses changes to the SSA CLD formula only.

------------------------------------------------------------------------
Sections of the Adult
Introductory Text and listings Revised sections of the Adult
for skin disorders prior to the Introductory Text and Listings for
effective date of this final rule Skin Disorders
------------------------------------------------------------------------
Introductory Text, 8.00
------------------------------------------------------------------------
A. What skin disorders do we A. Which skin disorders do we
evaluate with these listings?. evaluate under these listings?
B. What documentation do we need? [8.00C]
[8.00C].......................... B. What are our definitions for the
following terms used in this body
system?
C. How do we assess the severity [8.00D]
of your skin disorder(s)?.
[8.00B].......................... C. What evidence do we need to
evaluate your skin disorder?
D. How do we assess impairments [8.00H]
that may affect the skin and
other body systems?
[8.00C].......................... D. How do we evaluate the severity of
skin disorders?
E. How do we evaluate genetic E. How do we evaluate genetic
photosensitivity disorders?. photosensitivity disorders under
8.07?
F. How do we evaluate burns?..... F. How do we evaluate burns under
8.08?
G. How do we determine if your [8.00D]
skin disorder(s) will continue
at a disabling level of severity
in order to meet the duration
requirement?.
[8.00C].......................... G. How do we evaluate chronic
conditions of the skin or mucous
membranes under 8.09?
H. How do we assess your skin [8.00I]
disorder(s) if your impairment
does not meet the requirements
of one of these listings?
[8.00D].......................... H. How do we evaluate disorders in
other body systems that affect the
skin?
[8.00H].......................... I. How do we evaluate skin disorders
that do not meet one of these
listings?
------------------------------------------------------------------------
Listings
------------------------------------------------------------------------
8.01 Category of Impairments, 8.01 Category of Impairments, Skin
Skin Disorders. Disorders
8.02 Ichthyosis.................. 8.02 [Reserved] [Now evaluated in
8.09]

[[Page 37711]]

8.03 Bullous disease............. 8.03 [Reserved] [Now evaluated in
8.09]
8.04 Chronic infections of the 8.04 [Reserved] [Now evaluated in
skin or mucous membranes. 8.09]
8.05 Dermatitis.................. 8.05 [Reserved] [Now evaluated in
8.09]
8.06 Hidradenitis suppurativa.... 8.06 [Reserved] [Now evaluated in
8.09]
8.07 Genetic photosensitivity 8.07 Genetic photosensitivity
disorders. disorders
8.08 Burns....................... 8.08 Burns
[8.02-8.06]...................... 8.09 Chronic conditions of the skin
or mucous membranes
------------------------------------------------------------------------

The following table summarizes the current and revised sections of
the childhood skin disorders introductory text and listings.

------------------------------------------------------------------------
Sections of the Childhood
Introductory Text and listings Revised sections of the Childhood
for skin disorders prior to the Introductory Text and listings for
effective date of this final rule skin disorders
------------------------------------------------------------------------
Introductory Text, 108.00
------------------------------------------------------------------------
A. What skin disorders do we A. Which skin disorders do we
evaluate with these listings?. evaluate under these listings?
B. What documentation do we need? [108.00C]
[108.00C]........................ B. What are our definitions for the
following terms used in this body
system?
C. How do we assess the severity [108.00D]
of your skin disorder(s)?.
[108.00B]........................ C. What evidence do we need to
evaluate your skin disorder?
D. How do we assess impairments [108.00H]
that may affect the skin and
other body systems?.
[108.00C]........................ D. How do we evaluate the severity of
skin disorders?
E. How do we evaluate genetic E. How do we evaluate genetic
photosensitivity disorders?. photosensitivity disorders under
108.07?
F. How do we evaluate burns?..... F. How do we evaluate burns under
108.08?
G. How do we determine if your [108.00D]
skin disorder(s) will continue
at a disabling level of severity
in order to meet the duration
requirement?.
[108.00C]........................ G. How do we evaluate chronic
conditions of the skin or mucous
membranes under 108.09?
H. How do we assess your skin [108.00I]
disorder(s) if your impairment
does not meet the requirements
of one of these listings?
[108.00D]........................ H. How do we evaluate disorders in
other body systems that affect the
skin?
[108.00H]........................ I. How do we evaluate skin disorders
that do not meet one of these
listings?
------------------------------------------------------------------------
Listings
------------------------------------------------------------------------
108.01 Category of Impairments, 108.01 Category of Impairments, Skin
Skin Disorders. Disorders
108.02 Ichthyosis................ 108.02 [Reserved] [Now evaluated in
108.09]
108.03 Bullous disease........... 108.03 [Reserved] [Now evaluated in
108.09]
108.04 Chronic infections of the 108.04 [Reserved] [Now evaluated in
skin or mucous membranes. 108.09]
108.05 Dermatitis................ 108.05 [Reserved] [Now evaluated in
108.09]
108.06 Hidradenitis suppurativa.. 108.06 [Reserved] [Now evaluated in
108.09]
108.07 Genetic photosensitivity 108.07 Genetic photosensitivity
disorders. disorders
108.08 Burns..................... 108.08 Burns
[108.02-108.06].................. 108.09 Chronic conditions of the skin
or mucous membranes
------------------------------------------------------------------------

The following table shows our changes to the adult and childhood
skin disorders listings criteria that involve changes to healthcare
utilization and condition/episode requirements, the rationale for each
change, and supporting resources.

[[Page 37712]]

Adult and Childhood Skin Disorders Listings Criteria--Changes in
Healthcare Utilization and Condition/Episode Requirements
------------------------------------------------------------------------
Introductory text
or listing Revised
criteria prior to Introductory text
the effective or listing Rationale Resources
date of this criteria
final rule
------------------------------------------------------------------------
Introductory Text--8.00/108.00
------------------------------------------------------------------------
No current 8.00D5/108.00D5 The revised Farahnik, B.,
introductory c. Treatment with introductory Nakamura, M.,
text PUVA (psoralen text about Singh, R.K.,
and ultraviolet deferment for Abrouk, M.,
A (UVA) light) PUVA treatment Zhu, T.H., Lee,
or biologics. If is supported by K.M., . . .
you receive medical Liao, W.
additional research. PUVA (2016). The
treatment with treatment patient's guide
PUVA or involves to psoriasis
biologics to exposure to UVA treatment. Part
treat your skin light after 2: PUVA
disorder(s), we taking biologic phototherapy.
will defer medication Dermatology and
adjudication of called psoralen Therapy, 6(3),
your claim for 6 that increases 315-324. https:/
months from the the skin's /doi.org/
start of sensitivity to 10.1007/s13555-
treatment with ultraviolent 016-0130-9.
PUVA or light. PUVA is Ong, S., &
biologics to generally used Venning, V.
evaluate the under medical (2014). PUVA
effectiveness of supervision treatment
these treatments when other information for
unless we can conservative patients.
make a fully treatments for Retrieved from
favorable skin disorders Oxford
determination or have proven to University
decision on be ineffective. Hospital NHS
another basis We defer website: https:/
adjudication /www.ouh.nhs.uk/
for 6 months patient-guide/
from the start leaflets/files/
of treatment to 120719puva.pdf.
assess the Shenoi, S.D., &
effectiveness Prabhu, S.
of PUVA (2014).
treatment on Photochemothera
the skin py (PUVA) in
condition psoriasis and
vitiligo.
Indian Journal
of Dermatology,
Venereology and
Leprology,
80(6), 497-504.
https://doi.org/10.4103/0378-6323.144143.
------------------------------------------------------------------------

[[Page 37713]]

8.07/108.07 Genetic photosensitivity disorders
------------------------------------------------------------------------
8.07/108.07 8.07/108.07 The requirement 44 FR 18170,
Genetic Genetic that the 18187 (1979),
photosensitivity photosensitivity claimant's skin 45 FR 55566,
disorders, disorders, disorder 55607 (1980),
established as established as results in and 50 FR
described in described in significant 50068, 50098
8.00E and 8.00E and functional (1985).
108.00E 108.00E. The limitations Falder, S.,
B. Other genetic requirements of lasting a Browne, A.,
photosensitivity this listing are minimum of 12 Edgar, D.,
disorders, with: met if either months dates Staples, E.,
1. Extensive skin paragraph A or back to Fong, J., Rea,
lesions that paragraph B is 1979.\10\ The S., & Wood, F.
have lasted or satisfied language in the (2009). Core
can be expected B. Other genetic revised listing outcomes for
to last for a photosensitivity reflects a adult burn
continuous disorders (see continuation of survivors: A
period of at 8.00E2 and this clinical
least 12 months, 108.00E2) with requirement, overview.
OR either 1 or 2: stating that we Burns, 35(5),
2. Inability to 2. Chronic skin must have 618-641. https:/
function outside lesions (see medically /doi.org/
of a highly 8.00B2 and documented 10.1016/
protective 108.00B2) or evidence of j.burns.2008.09
environment for contractures physical .002; Haslik,
a continuous (see 8.00B3 and limitation(s) W., Kamolz, L.,
period of at 108.00B3) of functioning Manna, F.,
least 12 months causing chronic related to the Hladik, M.,
(see 8.00E2 and pain or other claimant's skin Rath, T., &
108.00E2) physical disorder, and Frey, M.
limitation(s) that the (2010).
that result in decrease in Management of
impairment- physical full-thickness
related function skin defects in
functional resulting from the hand and
limitations (see the claimant's wrist region:
8.00D2 and skin disorder First long-term
108.00D2), as must have experiences
evidenced by: lasted, or can with the dermal
a. Inability to be expected to matrix
use both upper last, for a Matriderm[supre
extremities to continuous g]. Journal of
the extent that period of at Plastic,
neither can be least 12 months Reconstructive
used to The revised & Aesthetic
independently functional Surgery, 63(2),
initiate, criteria focus 360-364. https:/
sustain, and on the person's /doi.org/
complete work- ability to use 10.1016/
related their upper and j.bjps.2008.09.
activities (or lower 026; Wasiak,
age-appropriate extremities to J., Lee, S.,
activities in perform work- Paul, E.,
childhood related Mahar, P.,
claims) activities or Pfitzer, B.,
involving fine engage in age- Spinks, A., . .
and gross appropriate . Gabbe, B.
movements (see activities in (2014).
8.00B5 and childhood Predictors of
108.00B5) due to claims. These health status
chronic skin revisions and health-
lesions (see reflect our related quality
8.00B2 and continued focus of life 12
108.00B2) or on the months after
contractures functional severe burn.
(see 8.00B3 and limitations Burns, 40(4),
108.00B3); or that skin 568-574;
b. Inability to disorders may 81 FR 43048
use one upper cause and (2016).
extremity to reflect a level
independently of functional
initiate, limitation
sustain, and similar to the
complete work- criteria in our
related current rules.
activities (or We clarify our
age-appropriate policy by
activities in providing
childhood precise
claims) functional
involving fine criteria rather
and gross than examples
movements (see as in the
8.00B5 and current skin
108.00B5) due to disorders
chronic skin listings to
lesions (see ensure that
8.00B2 and adjudicators do
108.00B2) or not overlook
contractures the functional
(see 8.00B3 and criteria and
108.00B3), and a that we
documented evaluate
medical need functional
(see 8.00B4 and limitations
108.00B4) for an caused by a
assistive device person's skin
(see 8.00B1 and impairment in a
108.00B1) that consistent
requires the use manner across
of the other cases
upper extremity; Additionally,
or the revised
c. Inability to requirement
stand up from a that the
seated position claimant have
and maintain an significant
upright position limitations in
to the extent the use of two
needed to extremities is
independently consistent with
initiate, the level of
sustain, and functional
complete work- limitations set
related forth in other
activities (or listing
age-appropriate criteria, such
activities in as in our
childhood neurological
claims) due to disorders
chronic skin listings (11.00/
lesions (see 111.00), which
8.00B2 and require
108.00B2) or ``disorganizati
contractures on of motor
(see 8.00B3 and function'' in
108.00B3) two extremities
affecting at
least two
extremities
(including when
limitations are
due to
involvement of
the perineum or
the inguinal
region); or
d. Inability to
maintain an
upright position
while standing
or walking to
the extent
needed to
independently
initiate,
sustain, and
complete work-
related
activities (or
age-appropriate
activities in
childhood
claims), due to
chronic skin
lesions (see
8.00B2 and
108.00B2) or
contractures
(see 8.00B3 and
108.00B3)
affecting both
lower
extremities
(including when
the limitations
are due to
involvement of
the perineum or
the inguinal
region).
------------------------------------------------------------------------

[[Page 37714]]

Listing 8.08/108.08 Burns
------------------------------------------------------------------------
8.08/108.08 8.08/108.08 Burns The requirement 44 FR 18170,
Burns, with (see 8.00F and that the 18187 (1979),
extensive skin 108.00F). Burns claimant's skin 45 FR 55566,
lesions that that do not disorder 55607 (1980),
have lasted or require results in and 50 FR
can be expected continuing significant 50068, 50098
to last for a surgical functional (1985).
continuous management (see limitations Falder, S.,
period of at 8.00B6 and lasting a Browne, A.,
least 12 months 108.00B6), or minimum of 12 Edgar, D.,
(see 8.00F and that have been months dates Staples, E.,
108.00F) documented by an back to Fong, J., Rea,
acceptable 1979.\11\ The S., & Wood, F.
medical source language in the (2009). Core
to have reached revised listing outcomes for
maximum reflects a adult burn
therapeutic continuation of survivors: A
benefit and this clinical
therefore are no requirement, overview.
longer receiving stating that we Burns, 35(5),
surgical must have 618-641. https:/
management, medically /doi.org/
resulting in documented 10.1016/
chronic skin evidence of j.burns.2008.09
lesions (see physical .002; Haslik,
8.00B2 and limitation(s) W., Kamolz, L.,
108.00B2) or of functioning Manna, F.,
contractures related to the Hladik, M.,
(see 8.00B3 and claimant's skin Rath, T., &
108.00B3) disorder, and Frey, M.
causing chronic that the (2010).
pain or other decrease in Management of
physical physical full-thickness
limitation(s) function skin defects in
that result in resulting from the hand and
impairment- the claimant's wrist region:
related skin disorder First long-term
functional must have experiences
limitations (see lasted, or can with the dermal
8.00D2 and be expected to matrix
108.00D2), as last, for a Matriderm[supre
evidenced by: continuous g]. Journal of
The functional period of at Plastic,
criteria set least 12 months Reconstructive
forth above in The revised & Aesthetic
listings 8.07B2a functional Surgery, 63(2),
through d and criteria, focus 360-364. https:/
108.07B2a on the person's /doi.org/
through d ability to use 10.1016/
their upper and j.bjps.2008.09.
lower 026; Wasiak,
extremities to J., Lee, S.,
perform work- Paul, E.,
related Mahar, P.,
activities or Pfitzer, B.,
engage in age- Spinks, A., . .
appropriate . Gabbe, B.
activities in (2014).
childhood Predictors of
claims. These health status
revisions and health-
reflect our related quality
continued focus of life 12
on the months after
functional severe burn.
limitations Burns, 40(4),
that skin 568-574;
disorders may 81 FR 43048
cause and (2016).
reflect a level
of functional
limitation
similar to the
criteria in our
current rules.
We clarify our
policy by
providing
precise
functional
criteria rather
than examples
as in the
current skin
disorders
listings to
ensure that
adjudicators do
not overlook
the functional
criteria and
that we
evaluate
functional
limitations
caused by a
person's skin
impairment in a
consistent
manner across
cases
Additionally,
the revised
requirement
that the
claimant have
significant
limitations in
the use of two
extremities is
consistent with
the level of
functional
limitations set
forth in other
listing
criteria, such
as in our
neurological
disorders
listings (11.00/
111.00), which
require
``disorganizati
on of motor
function'' in
two extremities
------------------------------------------------------------------------

[[Page 37715]]

Listing 8.09/108.09 Chronic conditions of the skin or mucous membranes
------------------------------------------------------------------------
No current 8.09/108.09 We consolidated 20 CFR 404.1509
listing. Note Chronic the current and 416.909.
that current conditions of listings into 44 FR 18170,
listings 8.02/ the skin or one listing for 18187 (1979),
108.02 mucous membranes adjudicative 45 FR 55566,
(Ichthyosis), (see 8.00G and ease and to 55607 (1980),
8.03/108/03 108.00G) more and 50 FR
(Bullous resulting in: efficiently 50068, 50098
disease), 8.04 A. Chronic skin capture adults (1985).
(Chronic lesions (see and children Falder, S.,
infections of 8.00B2 and with chronic Browne, A.,
the skin or 108.00B2) or skin conditions Edgar, D.,
mucous contractures of listing- Staples, E.,
membranes), 8.05 (see 8.00B3 and level severity. Fong, J., Rea,
(Dermatitis), 108.00B3) The requirement S., & Wood, F.
and 8.06 causing chronic that the (2009). Core
(Hidradenitis pain or other claimant's skin outcomes for
suppurativa) all physical disorder adult burn
require limitation(s) results in survivors: A
extensive skin that persist significant clinical
lesions that despite functional overview.
persist for at adherence to limitations Burns, 35(5),
least 3 months prescribed lasting a 618-641. https:/
despite medical minimum of 12 /doi.org/
continued treatment for 3 months dates 10.1016/
treatment as months (see back to j.burns.2008.09
prescribed. 8.00D5b and 1979.\12\ The .002; Haslik,
Under the 108.00D5b language in the W., Kamolz, L.,
revised skin AND revised listing Manna, F.,
disorders Impairment- reflects a Hladik, M.,
listings, all of related continuation of Rath, T., &
these skin functional this Frey, M.
conditions will limitations requirement, (2010).
be evaluated demonstrated by stating that we Management of
under listing the functional must have full-thickness
8.09/108.09. criteria set medically skin defects in
forth above in documented the hand and
listings 8.07B2a evidence of wrist region:
through d and physical First long-term
108.07B2a limitation(s) experiences
through d. of functioning with the dermal
related to the matrix
claimant's skin Matriderm[supre
disorder, and g]. Journal of
that the Plastic,
decrease in Reconstructive
physical & Aesthetic
function Surgery, 63(2),
resulting from 360-364. https:/
the claimant's /doi.org/
skin disorder 10.1016/
must have j.bjps.2008.09.
lasted, or can 026; Wasiak,
be expected to J., Lee, S.,
last, for a Paul, E.,
continuous Mahar, P.,
period of at Pfitzer, B.,
least 12 Spinks, A., . .
months. . Gabbe, B.
The revised (2014).
functional Predictors of
criteria focus health status
on the person's and health-
ability to use related quality
their upper and of life 12
lower months after
extremities to severe burn.
perform work- Burns, 40(4),
related 568-574;
activities or 81 FR 43048
engage in age- (2016).
appropriate
activities in
childhood
claims. These
revisions
reflect our
continued focus
on the
functional
limitations
that skin
disorders may
cause and
reflect a level
of functional
limitation
similar to the
criteria in our
current rules.
We clarify our
policy by
providing
precise
functional
criteria rather
than examples
as in the
current skin
disorders
listings to
ensure that
adjudicators do
not overlook
the functional
criteria and
that we
evaluate
functional
limitations
caused by a
person's skin
impairment in a
consistent
manner across
cases.
Additionally,
the revised
requirement
that the
claimant have
significant
limitations in
the use of two
extremities is
consistent with
the level of
functional
limitations set
forth in other
listing
criteria, such
as in our
neurological
disorders
listings (11.00/
111.00), which
require
``disorganizati
on of motor
function'' in
two
extremities.
------------------------------------------------------------------------

The following table shows our changes to references to BMI in other
body systems. Prior to the effective date of this final rule, the
formulas for calculating BMI are referenced as appearing in 5.00G and
105.00G2c in various listings, and we are correcting these references
to reflect the revised digestive disorders listings.
---------------------------------------------------------------------------

\10\ The introductory text to our 1979 final rule stated that
the claimant's skin lesions ``must be shown to have persisted for a
sufficient period of time despite therapy for a reasonable
presumption to be made that severe impairment will last for a
continuous period of at least 12 months.'' 44 FR at 18787.
\11\ Id.
\12\ Id.

----------------------------------------------------------------------------------------------------------------
Introductory Text prior to the effective Revised Introductory Text with updated
Listing paragraph date of this Final Rule cross-references
----------------------------------------------------------------------------------------------------------------
6.00C7.................... Anorexia (diminished appetite) with Anorexia (diminished appetite) with
weight loss. Anorexia is a frequent sign weight loss. Anorexia is a frequent sign
of CKD and can result in weight loss. We of CKD and can result in weight loss. We
will use body mass index (BMI) to will use body mass index (BMI) to
determine the severity of your weight determine the severity of your weight
loss under 6.05B4. (BMI is the ratio of loss under 6.05B4. (BMI is the ratio of
your measured weight to the square of your measured weight to the square of
your measured height.) The formula for your measured height.) We calculate your
calculating BMI is in section 5.00G. BMI using the formulas in the digestive
disorders body system (5.00).

[[Page 37716]]

14.00F5................... Measurement of CD4 and either body mass Measurement of CD4 and either body mass
index or hemoglobin (14.11G). To index or hemoglobin (14.11G). To
evaluate your HIV infection under evaluate your HIV infection under
14.11G, we require one measurement of 14.11G, we require one measurement of
your absolute CD4 count or your CD4 your absolute CD4 count or your CD4
percentage, and either a measurement of percentage, and either a measurement of
your body mass index (BMI) or your your body mass index (BMI) or your
hemoglobin. These measurements must hemoglobin. These measurements must
occur within the period we are occur within the period we are
considering in connection with your considering in connection with your
application or continuing disability application or continuing disability
review. If you have more than one review. If you have more than one
measurement of your CD4 (absolute count measurement of your CD4 (absolute count
or percentage), BMI, or hemoglobin or percentage), BMI, or hemoglobin
within this period, we will use the within this period, we will use the
lowest of your CD4 (absolute count or lowest of your CD4 (absolute count or
percentage), BMI, or hemoglobin. The percentage), BMI, or hemoglobin. The
date of your lowest CD4 (absolute count date of your lowest CD4 (absolute count
or percentage) measurement may be or percentage) measurement may be
different from the date of your lowest different from the date of your lowest
BMI or hemoglobin measurement. We BMI or hemoglobin measurement. We
calculate your BMI using the formulas in calculate your BMI using the formulas in
5.00G2. the digestive disorders body system
(5.00).
100.00C2c................. BMI is the ratio of a child's weight to BMI is the ratio of a child's weight to
the square of his or her height. We the square of his or her height. We
calculate BMI using the formulas in calculate BMI using the formulas in the
105.00G2c. digestive disorders body system
(105.00).
103.00K2c................. BMI is the ratio of a child's weight to BMI is the ratio of a child's weight to
the square of his or her height. We the square of his or her height. We
calculate BMI using the formulas in calculate BMI using the formulas in the
105.00G2c. digestive disorders body system
(105.00).
104.00C3b(iii)............ BMI is the ratio of a child's weight to BMI is the ratio of a child's weight to
the square of his or her height. We the square of his or her height. We
calculate BMI using the formulas in calculate BMI using the formulas in the
105.00G2c. digestive disorders body system
(105.00).
106.00C5b(iii)............ BMI is the ratio of a child's weight to BMI is the ratio of a child's weight to
the square of his or her height. We the square of his or her height. We
calculate BMI using the formulas in calculate BMI using the formulas in the
105.00G2c. digestive disorders body system
(105.00).
114.00F7b(iii)............ BMI is the ratio of a child's weight to BMI is the ratio of a child's weight to
the square of his or her height. We the square of his or her height. We
calculate BMI using the formulas in calculate BMI using the formulas in the
105.00G2c. digestive disorders body system
(105.00).
----------------------------------------------------------------------------------------------------------------

We are making several changes from the NPRM to this final rule for
digestive disorders and skin disorders:
The following is a high-level summary of the major changes
from the NPRM to this final rule. Below, in the section titled Public
Comments on the NPRM, we describe in greater detail our response to
questions and public comments, as well as changes from the NPRM to this
final rule. Further, these responses provide additional details about
our rule changes from our current rules, through the NPRM, and to our
final rule for digestive disorders and skin disorders.
We also made minor, editorial changes from the NPRM for
clarity and readability throughout both digestive disorders and skin
disorders.

Digestive Disorders

Hepatopulmonary syndrome: We revised the regulatory text
for hepatopulmonary syndrome to describe relevant clinical findings
associated with this complication of chronic liver disease (CLD)
(5.00C2 and 105.00C2 (Manifestations of CLD)).
SSA Chronic Liver Disease (SSA CLD) and SSA Chronic Liver
Disease-Pediatric (SSA CLD-P) scores: In the introductory text to the
listing, we modified the SSA CLD calculation. We added a sentence to
clarify that if you have the two SSA CLD scores required by 5.05G
(``Two SSA CLD scores'') and 105.05G1 (``For children age 12 and
older''), we will find that your impairment meets the criteria of the
listing from at least the date of the first SSA CLD score (5.00C3 (SSA
Chronic Liver Disease (SSA CLD) score) and 105.00C3 (SSA Chronic Liver
Disease (SSA CLD) and SSA Chronic Liver Disease-Pediatric (SSA CLD-P)
scores); 5.05G (``Two SSA CLD scores'') and 105.05G1 (``For children
age 12 or older''). We also removed the reference to SSA CLD-P scores
in 105.05G1 (``For children age 12 or older'').
Inflammatory bowel disease (IBD): In the listing
introductory text, we added perianal disease and extraintestinal
manifestations with examples for each. We also clarified the
consideration of surgical diversion of the intestinal tract (5.00D and
105.00D (What is inflammatory bowel disease (IBD), and how do we
evaluate it under 5.06/105.06)). We retained the consideration of
anemia and serum albumin from the current criteria in revised listings
5.06B1, 5.06B2, 105.06B1 and 105.06B2.
Supplemental nutrition: We expanded the listing
introductory text and criteria for the alternative method of
supplemental daily enteral nutrition to meet the listing to include
duodenostomy or jejunostomy (5.06B and 105.06B (``Two of the following
occurring within a consecutive 12-month period'') and 105.10 (Need for
supplemental daily enteral feeding via a gastrostomy, duodenostomy, or
jejunostomy)).
Intestinal failure: We expanded the listing introductory
text and criteria for short bowel syndrome (SBS) to include intestinal
failure and added descriptions of different types of intestinal failure
(5.00E and 105.00E (What is intestinal failure, and how do we evaluate
it under 5.07/105.07?); 5.07 and 105.07 (Intestinal failure)).
Weight loss due to any digestive disorder: We retained the
current criteria, for weight loss due to any digestive disorder, rather
than finalizing the proposed criteria for malnutrition due to any
digestive disorder (5.00F (How do we evaluate weight loss due to any
digestive disorder under 5.08?) and 5.08 (Weight loss due to any
digestive disorder)). Although it is not a policy change, in this final
rule, we also updated the language in the listing text to refer to
``adherence to prescribed medical treatment'' instead of ``continuing
treatment as prescribed,'' for consistency with medical terminology and
the changes we made to the skin disorders listings. Additionally, we
added language to the introductory text in 5.00F (How do we evaluate
weight loss due to any digestive disorder under 5.08?) and 105.00F (How
do we evaluate growth failure due to any digestive disorder under
105.08?) to explain how we consider weight loss or growth failure due
to impairments other than digestive disorders.
Chronic liver disease: We reorganized the criteria in
5.05A and 105.05A (``Hemorrhaging from esophageal, gastric, or ectopic
varices'') to use an outline format rather than text paragraphs. We did
this to improve clarity and readability, but there were no substantive
changes to the criteria.
References to BMI in other body systems: As we finalize
revisions to the

[[Page 37717]]

digestive disorders listings, we are revising cross references in other
body systems to correct citations to the BMI formula because they will
be outdated once this rule is effective. Specifically, we made these
revisions to 6.00C7, 14.00F5, 100.00C2c, 103.00K2c, 104.00C3b(iii),
106.00C5b(iii), and 114.00F7b(iii).

Skin Disorders

Definitions: We added assistive devices used in a seated
position to the list of examples of assistive devices. We also added a
definition for exacerbation (8.00B and 108.00B (What are our
definitions for the following terms used in this body system?)).
Evidence: We clarified that we consider any available
history of familial incidence (8.00C and 108.00C (What evidence do we
need to evaluate your skin disorder?)).
Functional criteria: We clarified that the inability to
perform fine and gross movements is due to chronic skin lesions or
contractures, consistent with the other two functional criteria (8.00D2
and 108.00D2 (Limitation(s) of physical functioning due to skin
disorders)).
Adherence to prescribed treatment: We changed the term
``physician'' to ``medical source'' in 8.00D5b and 108.00D5b (Despite
adherence to prescribed medical treatment for 3 months) to include
treatment prescribed by any medical source.\13\
---------------------------------------------------------------------------

\13\ 20 CFR 404.1502(d) and 416.902(i).
---------------------------------------------------------------------------

Burns: We removed the ``third-degree'' qualifier in front
of burns (8.00F and 108.00F (How do we evaluate burns under 8.08/
108.08); 8.08 and 108.08 (Burns)).
Improving Clarity and Readability: We revised the language
in 8.07B2 and 108.07B2 (``Chronic skin lesions or contractures''), 8.08
and 108.08 (Burns), and 8.09 and 108.09 (Chronic conditions of the skin
or mucous membranes) to remove repetitive language and make the
criteria easier to understand and apply.

Public Comments on the NPRM

In the NPRM, we provided the public with a 60-day comment period,
which ended on September 23, 2019. We received 14 comments. The
comments came from advocacy groups, legal services organizations, a
State agency that makes disability determinations for us, medical
organizations, and individual commenters. Multiple commenters provided
identical (or very similar) comments and recommendations.
We carefully considered all of the comments related to this
rulemaking. We have tried to summarize the commenters' views accurately
and have responded to all of the significant issues raised by the
commenters that were within the scope of this rule. We have not
summarized or responded to comments that were outside the scope of the
proposed rule. Some commenters noted provisions with which they agreed
but did not make suggestions for changes in those provisions. We did
not summarize or respond to those comments.

Digestive Disorders

Chronic Liver Disease (CLD)
Comment: Two commenters suggested that we use the Model for End-
Stage Liver Disease (MELD) formula rather than the SSA CLD formula. One
commenter suggested we use the MELD formula so we could keep pace with
changes in the treatment of digestive disorders without having to
update our regulations. Another commenter noted that even when SSA CLD
scores are available in the medical record, they are not used by SSA
adjudicators, and requested that we use the SSA CLD scores when
available. The commenter suggested that if the SSA CLD is unavailable,
we use the MELD scores when available in the medical record.
Response: We partially adopted this comment. In the 2007 Revised
Medical Criteria for Evaluating Digestive Disorders final rule, we
explained that the MELD is a numerical scale developed for the United
Network for Organ Sharing (UNOS) that is used to determine a person's
placement on the liver transplant list within the Organ Procurement and
Transplant Network (OPTN).\14\ The MELD score is based on objective and
verifiable medical data and estimates a person's risk of dying while
waiting for a liver transplant. In 2016, the MELD formula was modified
to take serum sodium levels into account under certain
situations.^{15 16}
---------------------------------------------------------------------------

\14\ 72 FR 59398 (2007).
\15\ Organ Procurement and Transplantation Network & United
Network for Organ Sharing. (2015). Changes to OPTN bylaws and
policies from actions at OPTN/UNOS Executive Committee meetings July
2015-November 2015 [PDF]. https://optn.transplant.hrsa.gov/media/1575/policynotice_20151101.pdf.
\16\ United Network for Organ Sharing. (2016). Policy and system
changes effective January 11, 2016, adding serum sodium to MELD
calculation. https://unos.org/news/policy-and-system-changes-effective-january-11-2016-adding-serum-sodium-to-meld-calculation/.
---------------------------------------------------------------------------

The SSA CLD calculation under the current rules was the
mathematical equivalent to the MELD formula used in 2007, and we
initially proposed no changes to this calculation in the
NPRM.^{17 18} However, in response to comments that we adopt
the MELD formula, we reviewed the updated 2016 MELD formula and
assessed its use in our disability program. We learned that for people
with certain chronic liver diseases, formulas utilizing serum sodium
levels predict negative outcomes more accurately than formulas that do
not consider serum sodium levels.^{19 20} As a result, we
modified the SSA CLD calculation to also account for serum sodium
levels under certain situations, so it remains mathematically
equivalent to the new MELD calculation. However, we did not directly
adopt the commenters' suggestion that we reference the MELD score in
our listing criteria, for reasons explained below.
---------------------------------------------------------------------------

\17\ 72 FR 59398 (2007).
\18\ 84 FR 35936 (2019).
\19\ Vaa, B.E., Asrani, S.K., Dunn, W., Kamath, P.S., & Shah,
V.H. (2011). Influence of serum sodium on MELD-based survival
prediction in alcoholic hepatitis. Mayo Clinic Proceedings, 86(1),
37-42. https://doi.org/10.4065/mcp.2010.0281.
\20\ Londo[ntilde]o, M.-C., C[aacute]rdenas, A., Guevara, M.,
Quint[oacute], L., de las Heras, D., Navasa, M., Rimola, A., Garcia-
Valdecasas, J.-C., Arroya, V., & Gin[egrave]s, P. (2007). MELD score
and serum sodium in the prediction of survival of patients with
cirrhosis awaiting liver transplantation. Gut, 56(9), 1283-1290.
https://doi.org/10.1136/gut.2006.102764.
---------------------------------------------------------------------------

As demonstrated in the table below, the SSA CLD and the MELD are
nearly identical, aside from the placement of a multiplier. Despite
this difference, the two formulas yield identical results.
---------------------------------------------------------------------------

\21\ International Normalized Ratio (INR) is a common laboratory
test that measures the amount of time it takes for the blood to
clot.

------------------------------------------------------------------------
MELD SSA CLD
------------------------------------------------------------------------
[0.378 * loge(bilirubin)) + (1.120 * (3.78 * loge(bilirubin)) +
loge(INR \21\)) + (0.957 * (11.20 * loge(INR)) + (9.57 *
loge(creatinine)) + 0.643] * 10. loge(creatinine)) + 6.43.
------------------------------------------------------------------------
If resulting value (MELD(i)) or SSA CLD(i)) is 12 or greater, the serum
sodium value is considered in the following way:
------------------------------------------------------------------------
MELD(i) + 1.32 * (137-Na)- SSA CLD(i) + 1.32 * (137-Na)-
[0.033*MELD(i) * (137-Na)]. [0.033*SSA CLD(i) * (137-Na)].
------------------------------------------------------------------------

[[Page 37718]]

We modified the SSA CLD formula rather than directly adopting the
MELD formula for multiple reasons. First, we use the SSA CLD score for
different purposes than the medical community uses the MELD score.
Specifically, MELD scores are used to determine a person's placement on
the liver transplant list, while SSA CLD scores are used to determine
whether a person's chronic liver disease is severe enough to preclude
the performance of any gainful activity. While our analysis shows that
the new SSA CLD calculation, which is mathematically equivalent to the
current MELD calculation, is appropriate for our programmatic use,
going forward, our analysis and research may determine that a SSA CLD
calculation which differs from the MELD calculation is more appropriate
for a determination of listing-level chronic liver disease. Likewise,
the MELD calculation may change in a way that precludes us from using
it to determine listing-level chronic liver disease. Because the MELD
is maintained by an independent entity, we may not know of the change
until it is in effect, and therefore would be tied to using an
inappropriate formula until we were able to publish a regulatory
change. In such instances, it is important that we retain flexibility
and use our own calculation, rather than adopt the MELD formula, as the
commenter suggests.
Moreover, the SSA CLD has unique testing standards that are
consistent with our programmatic requirements. For instance, for the
SSA CLD, we require that all laboratory values be obtained within a
continuous 30-day period, and we do not use any INR values derived from
testing done while the claimant is on anticoagulant treatment. These
requirements are not in place for the MELD calculation (see 5.00C3 (SSA
Chronic Liver Disease (SSA CLD) score) and 105.00C3a (SSA CLD score)).
Finally, the SSA CLD score is familiar to our adjudicators because we
began using it in 2007.
The commenter also misunderstands our use of SSA CLD scores.
Because SSA CLD scores result from our regulatory formula, they are
generally not available in the medical record, nor do we expect them to
be. Instead, adjudicators must calculate the SSA CLD score using a
formula that includes up to four laboratory values. The calculation is
set forth in our regulations at 5.00C3 (SSA Chronic Liver Disease (SSA
CLD) score) and 105.00C3a (SSA CLD score). Regardless of the formula
used, we require the component values be present in the medical
evidence of record, and then our adjudicators input those values into a
calculator to determine the score based on the regulatory formula.
With regard to our changes to the SSA CLD formula, we describe the
modified SSA CLD calculation in the introductory text in this final
rule in paragraphs 5.00C3 (SSA Chronic Liver Disease (SSA CLD) score)
and 105.00C3a (SSA CLD score). We reorganized the order of paragraphs
5.00C3b (``For any SSA CLD calculation'') and 5.00C3c (``When we
indicate `loge' '') and 105.00C3a(ii) (``For any SSA CLD
calculation'') and 105.00C3a(iii) (``When we indicate `loge'
'') for clarity. We updated the instructions for rounding and limits
for maximum and minimum values in paragraphs 5.00C3b and 105.00C3a(ii)
(``For any SSA CLD calculation'') to reflect the addition of serum
sodium to the CLD formula. Finally, we updated the CLD calculation
examples in paragraphs 5.00C3c and 105.00C3a(iii) (``When we indicate
`loge' '') to reflect the change in the formula.
Comment: One commenter stated that we do not provide evidence that
SSA CLD scores greater than or equal to 20 are a measure of the ability
or inability to engage in substantial gainful activity (SGA).
Response: We disagree. The rule change reflects medical research
showing the increased 3-month mortality risk and overall clinical
severity indicated by laboratory values resulting in an SSA CLD score
of at least 20.^{22 23 24} For instance, individuals with a
MELD score ranging from 10-19 have a 3-month mortality rate of 6%,
whereas individuals with a MELD score between 20 and 29 have a 3-month
mortality rate of 19.6%, which means they are more than three times
more likely to die within 3 months if they do not receive a
transplant.\25\ As explained above, the MELD score is equivalent to the
SSA CLD score. This degree of severity is consistent with liver disease
that will prevent an adult from engaging in any gainful activity,
result in death, or cause marked and severe limitations in children
over the age of 12. Clinical practice uses the MELD formula, which we
describe above as equivalent to the SSA CLD, to evaluate liver disease
for individuals age 12 and older. However, because the formula that our
SSA CLD-P score is based on is only used for individuals under age 12,
we removed listing criteria considering an SSA CLD-P score of at least
20 from revised listing 105.05G1 (``For children age 12 and older'')
that was initially included in the NPRM.
---------------------------------------------------------------------------

\22\ Singal, A.K., & Kamath, P.S. (2012). Model for end-stage
liver disease. Journal of Clinical and Experimental Hepatology,
3(1), 50-60. https://doi.org/10.1016/j.jceh.2012.11.002.
\23\ Zhang, E.-L., Zhang, Z.-Y., Wang, S.-P., Xiao, Z.-Y, Gu,
J., Xiong, M, Chen, X.-P., & Huang, Z.-Y. (2016). Predicting the
severity of liver cirrhosis through clinical parameters. Journal of
Surgical Research, 204(2), 274-281. https://doi.org/10.1016/j.jss.2016.04.036.
\24\ Thornton, K. (2021, February 12). Evaluation and Prognosis
of Persons with Cirrhosis. Hepatitis C Online. https://www.hepatitisc.uw.edu/go/evaluation-staging-monitoring/evaluation-prognosis-cirrhosis/core-concept/all.
\25\ Id.
---------------------------------------------------------------------------

The SSA CLD-P is based on the Pediatric Model for End Stage Liver
Disease (or the PELD), which was also developed by OPTN, and is used
for organ transplant allocation for persons under the age of 12. Unlike
the MELD, the PELD has not been changed since prior to the publication
of our 2007 revisions to the digestive disorders listings, where we
created the SSA CLD-P formula, as an equivalent to the PELD, to
evaluate liver disease under listing 105.05G2 (``For children who have
not attained age 12'').\26\ Similar to an SSA CLD score of at least 20,
medical research shows an increased 3-month mortality risk and overall
clinical severity indicated by laboratory values that result in an SSA
CLD-P score of at least 11.\27\ This level of severity continues to
identify liver disease severe enough to cause marked and severe
limitations in children under the age of 12. We therefore did not
propose a change to the existing SSA CLD-P formula in the NPRM, nor
were there public comments suggesting a revision to our formula based
on PELD.
---------------------------------------------------------------------------

\26\ 72 FR 59398 (2007).
\27\ Chung-Chou, H.C., Bryce, C.L., Shneider, B.L., Yabes, J.G.,
Ren, Y., Zenarosa, G.L., Tomko, H., Donnell, D.M., Squires, R.H., &
Roberts, M.S. (2018). Accuracy of the pediatric end-stage liver
disease score in estimating pretransplant mortality among pediatric
liver transplant candidates. JAMA Pediatrics, 172(11), 1070-1077.
https://doi.org/10.1001/jamapediatrics.2018.2541.
---------------------------------------------------------------------------

The commenter did not provide any alternatives or suggestions on
the revised text. Additionally, the commenter misstates the function of
our listings regarding gainful activity by using the phrase
``substantial gainful activity.'' The listings describe impairments
that we consider severe enough to prevent an adult from doing any
gainful activity.\28\ For children, the listings describe impairments
we consider severe enough to cause marked and severe functional
limitations.\29\
---------------------------------------------------------------------------

\28\ 20 CFR 404.1525(a) and 416.925(a).
\29\ 20 CFR 416.925(a).
---------------------------------------------------------------------------

Comment: Several commenters asked us to keep the current listing
direction in 5.05G and 105.05G (``End stage liver disease'') or replace
it with suggested text. The commenters suggested the

[[Page 37719]]

listing criteria should, ``consider [the person] under a disability no
later than the date of the first score'' for the required two SSA CLD
scores.
Response: We agree with the commenters. The current listing
language states we ``[c]onsider under a disability from at least the
date of the first score.'' While we proposed to remove this direction
in the NPRM, we did not intend to change our policy in the current rule
that we consider an individual under a disability from at least the
date of their first score. At the commenters' request and to avoid
confusion on this issue, we are no longer making the change proposed in
the NPRM and have retained the current listing direction to ``consider
under a disability from at least the date of the first score'' in
listings 5.05G (``Two SSA CLD scores'') and 105.05G1 (``For children
age 12 or older''). We also included applicable corresponding
introductory text in the final rule introductory paragraphs 5.00C3 (SSA
Chronic Liver Disease (SSA CLD) score) and 105.00C3a (SSA CLD score).
Comment: One commenter expressed that our proposed change to
listing 5.05G (``Two SSA CLD scores'') and 105.05G1 (``For children age
12 or older'') constitutes a new requirement for two SSA CLD scores and
would make a finding of disability dependent on access to expensive
care instead of medical considerations.
Response: We disagree with the characterization that it is a new
requirement that two SSA CLD scores are required to make a finding of
disability under the listing. Our current rules, at 5.00D11e (``Listing
5.05G requires two SSA CLD scores'') and 105.00D11a(v) (``Listing
105.05G requires two SSA CLD scores'') state that two SSA CLD scores
are required. The language ``[c]onsider under a disability from at
least the date of the first score'' does not mean the second SSA CLD
score is optional under 5.05G (``Two SSA CLD scores'') or 105.05G1
(``For children age 12 or older'').
Comment: One commenter suggested that we clarify the definition of
gastrointestinal hemorrhaging, which is necessary to establish listing-
level severity. To that end, the commenter suggested adding information
about clinical findings on endoscopy to proposed listing 5.05A
(``Hemorrhaging from esophageal, gastric, or ectopic varices'').
Response: We did not adopt this comment, because hemodynamic
instability findings, and the need for hospitalization for transfusion
of at least two units of blood, are the defining characteristics of
hemorrhage of listing-level severity under revised listing 5.05A
(``Hemorrhaging from esophageal, gastric, or ectopic varices'').
Although the underlying hemorrhage documented by imaging is a
requirement under revised listing 5.05A (``Hemorrhaging from
esophageal, gastric, or ectopic varices''), this imaging alone does not
establish listing-level severity. In addition to hemorrhaging from
esophageal, gastric, or ectopic varices, or from portal hypertensive
gastropathy documented by imaging, listing 5.05A (``Hemorrhaging from
esophageal, gastric, or ectopic varices'') also requires both the
finding of hemodynamic instability and hospitalization for transfusion
of at least two units of blood. We consider the suggested endoscopic
findings when they are present in the medical evidence.
Comment: Several commenters asked us to allow the use of pulse
oximetry results to demonstrate hepatopulmonary syndrome in listings
5.05E and 105.05E (``Hepatopulmonary syndrome''). One commenter
expressed concern about the appropriateness of arterial blood gas (ABG)
testing (as required under proposed 105.05E1 (``Arterial PaO2 measured
by an ABG test'')) in young children due to difficulties in
administration on young children.
Response: We did not adopt these comments. ABG testing is the
widely-accepted standard test for confirmatory diagnosis of hypoxemia
in suspected hepatopulmonary syndrome, regardless of the patient's
age.\30\ Although there can be some difficulties with administering ABG
tests on young children, such as bleeding, risks associated with
getting an ABG are relatively minor, and ABG testing remains the most
valid indicator of listing-level severity.^{31 32 33} Although
pulse oximetry is useful to screen a patient for hepatopulmonary
syndrome, it is generally not used as a diagnostic test, due to a risk
of false positives.\34\ The literature cited by the commenters stated
that ABG testing would still be required for final determination of
hepatopulmonary syndrome severity after any screening with pulse
oximetry.\35\ Furthermore, pulse oximetry is not as accurate as ABG
tests in cases of very low oxygen saturation, and may also be affected
by the use of certain cosmetics, skin pigmentation, or poor peripheral
circulation.\36\
---------------------------------------------------------------------------

\30\ Grilo-Bensusan, I., & Pascasio-Acevedo, J.M. (2016).
Hepatopulmonary syndrome: What we know and what we would like to
know. World Journal of Gastroenterology, 22(5), 5728-5741. https://doi.org/10.3748/wjg.v22.i25.5728.
\31\ Forde K.A., Fallon M.B., Krowka M.J., Sprys M., Goldberg
D.S., Krok K.L., Patel, M., Lin, G., Oh, J.K., Mottram, C.D.,
Scanlon, P.D., & Kawut S.M. (2019). Pulse oximetry is insensitive
for detection of hepatopulmonary syndrome in patients evaluated for
liver transplantation. Hepatology, 69(1), 270-281. https://doi.org/10.1002/hep.30139.
\32\ Noli, K., Solomon, M., Golding, F., Charron, M., & Ling,
S.C. (2008). Prevalence of hepatopulmonary syndrome in children.
Pediatrics, 121(3), e522-527. https://doi.org/10.1542/peds.2007-1075.
\33\ Arterial Blood Gas (ABG): What It Is, Purpose, Procedure &
Levels. (2022, February 18.). Cleveland Clinic. https://my.clevelandclinic.org/health/diagnostics/22409-arterial-blood-gas-abg.
\34\ Arguedas, M.R., Singh, H., Faulk, D.K., & Fallon, M.B.
(2007). Utility of pulse oximetry screening for hepatopulmonary
syndrome. Clinical Gasteroenterology and Hepatology, 5(6), 749-754.
https://doi.org/10.1016/j.cgh.2006.12.003.
\35\ Id.
\36\ Jubran, A. (2015). Pulse oximetry. Critical Care, 19, 272.
https://doi.org/10.1186/s13054-015-0984-8.
---------------------------------------------------------------------------

We consider all evidence in the case record when we evaluate claims
for disability benefits, including laboratory test results as a form of
objective medical evidence.\37\ If an impairment(s) does not satisfy
the listing requirement for an ABG measurement, then we will consider
whether the impairment(s) medically equals a listing.\38\ If an adult's
impairment(s) does not meet or medically equal any listing, they can be
found disabled at a later step in the sequential evaluation
process.\39\ If a child's impairment(s) does not meet or medically
equal any listing, including because the medical evidence in the record
does not contain necessary laboratory test results, we may find that
their impairment(s) functionally equals the listings.\40\ It is at this
stage that we would use all available medical and non-medical evidence
to evaluate whether a child's impairment(s) functionally equals the
listings, including pulse oximetry results.
---------------------------------------------------------------------------

\37\ 20 CFR 404.1520, 416.920, and 416.924.
\38\ 20 CFR 404.1526 and 416.926.
\39\ 20 CFR 404.1520 and 416.920.
\40\ 20 CFR 416.924.
---------------------------------------------------------------------------

Comment: Several commenters requested that, if we do not permit the
use of pulse oximetry results for listings 5.05E and 105.05E
(``Hepatopulmonary syndrome''), that we state that we will purchase ABG
testing for people with hepatopulmonary syndrome who have pulse
oximetry values below 96%.
Response: We did not adopt the comment. We do not require a
consultative examination in every case where there is evidence of a
pulse oximetry value below 96%. Our regulations governing the purchase
of consultative examinations already state that if we cannot obtain the
information we need from a claimant's medical sources to make a
determination or decision of disability, or when the other available
evidence on a claim is

[[Page 37720]]

insufficient, we may purchase the needed medical examinations or tests,
but this is an individualized and fact-specific determination.
Therefore, it would be inappropriate, and inconsistent with our
regulations, for SSA to purchase ABG testing when there are no
inconsistencies in the evidence, or when the evidence in the file is
sufficient to make a determination or decision on a claim.\41\
---------------------------------------------------------------------------

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

Comment: Commenters requested that we include a statement in
listings 5.05E and 105.05E (``Hepatopulmonary syndrome'') that
hypoxemia due to hepatopulmonary syndrome may also be evaluated under
listing 3.02C2 (Chronic respiratory disorders) or the childhood
respiratory listings. For proposed criterion in listing 5.05E1
(``Arterial PaO2 measured by an ABG test''), one
commenter asked us to either use both PaO2 and
PaCO2 values, or the highest favorable
PaO2 for each altitude range, as noted in tables
for PaO2/PaCO2 measurements
in the respiratory listing for hypoxemia.
Response: We did not adopt these comments. Hepatopulmonary syndrome
is not the same as hypoxemia caused by a chronic respiratory disorder.
Hepatopulmonary syndrome is not a respiratory disease. It is a rare
complication of liver disease, characterized by arterial deoxygenation
due to intrapulmonary vascular dilation and arteriovenous
shunting.^{42 43} Hypoxemia is defined as a below-normal level
of oxygen in the blood, specifically in the arteries.\44\ The only
effective treatment for hepatopulmonary syndrome is liver transplant.
Severity grading of hepatopulmonary syndrome is based on measurements
of PaO2, not PaCO2, and
5.05E1 and 105.05E1 consider altitude when determining whether a
claimant's hepatopulmonary syndrome is listing-level
severity.^{45 46} For these reasons, we are not including a
syndrome caused by liver disease in a respiratory listing. However, in
the regulatory text of the NPRM and the final rule, we state in
paragraphs 5.00J2 and 105.00L2 (``If you have a severe medically
determinable impairment(s) that does not meet a listing'') that if a
person's impairment(s) does not meet the requirements of a listing in
any body system, we may find that the impairment(s) is medically
equivalent to another listing. An impairment(s) is medically equivalent
to a listed impairment if it is at least equal in severity and duration
to the criteria of any listed impairment, including those listed in
5.00 and 105.00 (Digestive Disorders).\47\
---------------------------------------------------------------------------

\42\ Taber's Cyclopedic Medical Dictionary--23rd Ed. (2017).
\43\ Gladwin, M.T., & Levine, A.R. (2020, September).
Hepatopulmonary syndrome. The Merck Manual Professional Version.
https://www.merckmanuals.com/professional/pulmonary-disorders/pulmonary-hypertension/hepatopulmonary-syndrome.
\44\ Taber's Cyclopedic Medical Dictionary--23rd Ed. (2017).
\45\ Rodr[iacute]guez-Roisin, R., & Krowka, M.J. (1998).
Hepatopulmonary syndrome--a liver-induced lung vascular disorder.
The New England Journal of Medicine, 358, 2378-2387. https://doi.org/10.1056/NEJMra0707185.
\46\ Grilo-Bensusan, I., & Pascasio-Acevedo, J.M. (2016).
Hepatopulmonary syndrome: What we know and what we would like to
know. World Journal of Gastroenterology, 22(25), 5728-5741. https://doi.org/10.3748/wjg.v22.i25.5728.
\47\ 20 CFR 404.1526 and 416.926.
---------------------------------------------------------------------------

Comment: One commenter suggested we remove proposed criterion
5.05E2 (``Intrapulmonary arteriovenous shunting'') as it demonstrates
only the presence of hepatopulmonary syndrome and not a level of
hypoxemia or severity associated with proposed 5.05E1 (``Arterial PaO2
measured by an ABG test''). The commenter stated that it is not clear
that arteriovenous shunting as shown by the contrasted echocardiogram
or macroaggregated albumin lung scan required in proposed criterion
5.05E2 (``Intrapulmonary arteriovenous shunting'') necessarily equates
to the expected severity associated with the required hypoxemia levels
in proposed criterion 5.05E1 (``Arterial PaO2
measured by an ABG test''). The commenter noted that some of these
tests in proposed 5.05E2 (``Intrapulmonary arteriovenous shunting'')
are not quantitative, and not all of them are specific for
intrapulmonary shunting. The commenter asked us to add these tests to
the introductory text along with the symptoms of platypnea (shortness
of breath relieved when lying down) and orthodeoxia (low arterial blood
oxygen in the upright position) that are highly specific for
hepatopulmonary syndrome when present alongside chronic liver disease.
Response: We partially adopted the comment. We updated the
introductory text at 5.00C2e and 105.00C2e (Hepatopulmonary syndrome)
to include the clinical findings suggested by the commenter. While we
agree with the commenter that the criteria in 5.05E2 and 105.05E2
demonstrate the presence of hepatopulmonary syndrome and not a level of
hypoxemia, we kept the criterion because the presence of
hepatopulmonary syndrome, as confirmed by these tests, continues to be
indicative of listing-level severity. Hepatopulmonary syndrome is a
very serious consequence of chronic liver disease, is a progressive
condition, and has a high morbidity and mortality rate associated with
it.\48\ Currently, the only treatment is a liver transplant.\49\
---------------------------------------------------------------------------

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

Inflammatory Bowel Disease
Comment: A number of commenters questioned why ``perineal disease''
was removed from the list of signs and symptoms of inflammatory bowel
disease (IBD) in proposed 5.00D2 (``We evaluate your signs and symptoms
of IBD'') and urged its inclusion in the final rule.
Response: We adopted this comment. We agree that this is an
important complication of IBD; however, the medical community uses the
term perianal disease to describe the perianal complications that are
considered an early sign of IBD.\50\ So, we adopted the commenter's
suggestion, and changed the terminology to ``perianal disease.'' We
added this to the list of signs and symptoms of IBD in the introductory
text at 5.00D2 and 105.00D2 (``We evaluate your signs and symptoms of
IBD''), and provided examples (``for example, fissure, fistulas,
abscesses, and anal canal stenosis'') associated with perianal Crohn's
disease.
---------------------------------------------------------------------------

\50\ Galandiuk, S., Kimberling, J., Al-Mishlab, T.G., &
Stromberg, A.J. (2005). Perianal Crohn disease: Predictors of need
for permanent diversion. Annals of surgery, 241(5), 796-802. https://doi.org/10.1097/01.sla.0000161030.25860.c1.
---------------------------------------------------------------------------

Comment: Commenters recommended that the final version of the
listing include the language from current 5.00E3 (``IBD may be
associated with significant extraintestinal manifestations in a variety
of body systems'') about extraintestinal manifestations of IBD.
Response: We agree with the commenter and added the language from
current paragraph 5.00E3 (``IBD may be associated with significant
extraintestinal manifestations in a variety of body systems'') about
extraintestinal manifestations of IBD to paragraph 5.00D4 (``IBD may
also be associated with significant extraintestinal manifestations in a
variety of body systems''). For consistency between adult and child
listings, we also added the corresponding language from current
paragraph 105.00E3 (``IBD may be associated with significant
extraintestinal manifestations in a variety of body systems'') as
revised

[[Page 37721]]

paragraph 105.00D4 (``IBD may be associated with significant
extraintestinal manifestations in a variety of body systems''), and
renumbered proposed paragraph 105.00D4 as revised paragraph 105.00D5.
Comment: One commenter recommended that the tube feeding
description be expanded beyond ``gastric'' to other types (that is,
duodenal or jejunal) that are often required in patients with digestive
disorders.
Response: We adopted this comment because the commenter brought a
perspective that we had not considered, which was that types of tube
feeding which are similar in purpose should be included in the listing,
and our research confirmed that supplemental daily enteral nutrition
supplied via duodenostomy or jejunostomy is also representative of
listing-level severity.^{51 52 53} Therefore, we added tube
feeding via duodenostomy or jejunostomy to listings 5.06B and 105.06B
(``Two of the following occurring within a consecutive 12-month
period''), and 105.10 (Need for supplemental daily enteral feeding via
a gastrostomy, duodenostomy, or jejunostomy). We also provided guidance
about evaluating tube feedings in introductory text sections 5.00D2 and
105.00D2 (``We evaluate your signs and symptoms of IBD'') and 105.00H
(How do we evaluate the need for supplemental daily enteral feeding via
a gastrostomy, duodenostomy, or jejunostomy?).
---------------------------------------------------------------------------

\51\ Pearce, C.B. & Duncan, H.D. (2002). Enteral feeding.
Nasogastric, nasojejunal, percutaneous endoscopic gastrostomy, or
jejunostomy: its indications and limitations, Postgraduate Medical
Journal, 78, 198-204. https://doi.10.1136/pmj.78.918.198.
\52\ Brett, K. & Arg[aacute]ez, C. (2018). Gastrostomy versus
gastrojejunostomy and/or jejunostomy feeding tubes: a review of
clinical effectiveness, cost-effectiveness and guidelines. Ottawa
(ON): Canadian Agency for Drugs and Technologies in Health.
\53\ Clinical Nutrition University. (2021, May 25). Types of
Feeding Tubes EXPLAINED. YouTube. https://www.youtube.com/watch?v=4Oam1yUHiO8.
---------------------------------------------------------------------------

Short Bowel Syndrome and Intestinal Failure
Comment: One commenter agreed with the proposed changes to expand
the definition of short bowel syndrome (SBS) to consider ``surgical
resection of any amount of the small intestine,'' but suggested we
further expand the definition by adding ``the continual need for
nutritional intervention such as oral rehydration, enteral tube feeding
and/or parenteral nutrition is documented.''
Response: We did not adopt the comment. The listings describe
impairments that we consider severe enough to prevent an adult from
doing any gainful activity.\54\ The commenter's suggestion includes
oral rehydration and enteral tube feeding, which, when associated with
SBS or intestinal failure, are not indicative of a condition that is
listing-level severity.\55\ Since, on their own, these nutritional
interventions are not dispositive of a disorder that is severe enough
to prevent any gainful activity, we did not expand the definition of
SBS as the commenter suggested. However, we do consider evidence of
nutritional intervention alongside all other relevant information at
later steps in our sequential evaluation process.
---------------------------------------------------------------------------

\54\ 20 CFR 404.1525(a) and 416.925(a).
\55\ Nightingale, J. & Woodward, J.M. (2006). Guidelines for
management of patients with a short bowel. Gut, 55(Suppl IV), iv1-
iv12. https://doi.10.1136/gut.2006.091108.
---------------------------------------------------------------------------

Comment: One commenter asked us to expand the criteria for listings
5.07 and 105.07 (Intestinal failure) to ``support patients who are not
completely dependent on parenteral nutrition, but who will experience
better quality of life if it is supplementary in some form.''
Response: We did not adopt this comment. The statutory definition
of disability concerns a person's ability to do work, not on quality of
life.\56\ The commenter described alternative, less burdensome,
treatment options that assist patients with achieving independence, but
these alternatives, on their own, are not indicative of listing-level
severity. The listings are designed to identify cases at an early stage
of the sequential evaluation process that meet a strict threshold for
the statutory definition of disability. They describe impairments that
we consider severe enough to prevent an adult from doing any gainful
activity.\57\ For children, the listings describe impairments we
consider severe enough to cause marked and severe functional
limitations.\58\ If an impairment does not meet a listing, this does
not mean that we will deny a claim. If an adult's impairment(s) does
not meet or medically equal any listing, we may find that person
disabled at a later step in the sequential evaluation process.\59\ If a
child's impairment(s) does not meet or medically equal any listing, we
may find that their impairment(s) functionally equal the listings.\60\
---------------------------------------------------------------------------

\56\ 42 U.S.C. 416(i) and 423(d).
\57\ 20 CFR 404.1525(a) and 416.925(a).
\58\ 20 CFR 416.925(a).
\59\ 20 CFR 404.1520 and 416.920.
\60\ 20 CFR 416.924.
---------------------------------------------------------------------------

Comment: One commenter suggested we revise the listings for SBS
(5.07 and 105.07) or add a new listing to more broadly address
intestinal failure with need for parenteral nutrition. They suggested
that for children with impaired or absent intestinal motility from an
increasing number of congenital and acquired conditions, the same
impairments exist without the surgery requirement as with SBS (for
example, gastroschisis, omphalocele, long segment Hirschprung's, and
increasingly recognized disorders of mitochondria and other cellular
functions that severely impair intestinal functioning).
Response: We adopted this comment. Our intent in the proposed
expanded listings for SBS was to include individuals whose medical
records do not contain documentation of resection of more than one-half
of the small intestine, but whose loss of intestinal function is so
severe that daily parenteral nutrition is needed to maintain health.
Along these lines, the commenters brought a perspective that we had not
considered when they suggested the inclusion of other similar
intestinal conditions that could cause intestinal failure with the same
degree of impairment of gut function, but in the absence of SBS. When
we considered these comments, we accepted them, because the research
cited in the comments as well as our own supplemental research and
review of cases confirmed that other common causes of chronic
intestinal failure--specifically, extensive small bowel mucosal disease
and chronic motility disorders--can similarly impair intestinal
function and prevent absorption of macronutrients or water and
electrolytes below that necessary to

[[Page 37722]]

maintain life, also requiring daily parenteral
nutrition.^{61 62 63 64 65} Therefore, we expanded and renamed
listings 5.07 and 105.07 Intestinal failure to cover a greater range of
chronic dysmotility or absent motility disorders lasting or expected to
last at least 12 months and reducing gut function below the minimum
necessary for the absorption of macronutrients or water and
electrolytes sufficient for health, as we explain in the introductory
text in 5.00E1 and 105.00E1 (What is intestinal failure, and how do we
evaluate it under 5.07/105.07?).
---------------------------------------------------------------------------

\61\ Thompson JS, Rochling FA, Weseman RA, Mercer DF. Current
management of short bowel syndrome. Curr Probl Surg 49:52-115, 2012.
https://doi.org/10.1067/j.cpsurg.2011.10.002.
\62\ Pironi, L., Arends, J., Baxter, J., Bozzetti, F.,
Pel[aacute]ez, R.B., Cuerda, C., Forbes, A., Gabe, S., Gillanders,
L., Holst, M., Jeppesen, P.B., Joly, F., Kelly, D., Klek, S., Irtun,
[Oslash]., Olde Damink, S.W., Panisic, M., Rasmussen, H.H., Staun,
M., Szczepanek, K., . . . Acute Intestinal Failure Special Interest
Groups of ESPEN (2015). ESPEN endorsed recommendations. Definition
and classification of intestinal failure in adults. Clinical
nutrition (Edinburgh, Scotland), 34(2), 171-180. https://doi.org/10.1016/j.clnu.2014.08.017.
\63\ Pironi, L., Arends, J., Bozzetti, F., Cuerda, C.,
Gillanders, L., Jeppesen, P.B., Joly, F., Kelly, D., Lal, S., Staun,
M., Szczepanek, K., Van Gossum, A., Wanten, G., Schneider, S.M., &
Home Artificial Nutrition & Chronic Intestinal Failure Special
Interest Group of ESPEN (2016). ESPEN guidelines on chronic
intestinal failure in adults. Clinical nutrition (Edinburgh,
Scotland), 35(2), 247-307. https://doi.org/10.1016/j.clnu.2016.01.020.
\64\ Deutsch, L., Cloutier, A., & Lal, S. (2020). Advances in
chronic intestinal failure management and therapies. Current opinion
in gastroenterology, 36(3), 223-229. https://doi.org/10.1097/MOG.0000000000000631.
\65\ Pierret, A., Wilkinson, J.T., Zilbauer, M., & Mann, J.P.
(2019). Clinical outcomes in pediatric intestinal failure: a meta-
analysis and meta-regression. The American journal of clinical
nutrition, 110(2), 430-436. https://doi.org/10.1093/ajcn/nqz110.
---------------------------------------------------------------------------

Malnutrition
Comment: A number of commenters expressed concern about and
suggestions for our proposed criteria for malnutrition in listing 5.08
(Weight loss due to any digestive disorder), particularly the use of
laboratory values such as hemoglobin or albumin. Commenters also
suggested we remove the requirement that malnutrition be caused by a
digestive disorder. However, these commenters supported our proposed
change to the period over which the criteria must appear in the medical
evidence of record for listing 5.08 (Weight loss due to any digestive
disorder), as well as multiple other digestive listings, from a period
of 6 months to a period of 12 months.
Response: We carefully considered all of the concerns raised by the
commenters and concluded that we should not finalize our proposed
changes to add measurements of hemoglobin and albumin to this listing.
Intending to improve the specificity of the listing, we had proposed
these biomarkers in congruence with using the term ``malnutrition''
instead of ``weight loss'' along with proposing that weight loss be the
result of malnutrition caused by a digestive disorder. We reviewed the
comments and research supporting the comments ^{66 67}
suggesting that these measurements are not the best indicators of
listing-level weight loss in adults and we ultimately agreed with the
commenters that malnutrition caused by a digestive disorder does not
have a strong enough relationship with those biomarkers to include them
in the listing. That is, these biomarkers are not specific to
malnutrition and can instead be indicative of other conditions such as
cancers, autoimmune disorders, bleeding, and cardiovascular
diseases.^{68 69} We concluded that there are not currently
biomarkers or other clinical evidence that are both regularly available
in medical records and highly specific to severe, listing-level
malnutrition. Therefore, after consultation with agency medical experts
and reviewing research provided by one of the commenters, we determined
that the BMI remains the most specific and readily available
documentation of digestive disorders that have caused weight loss so
severe that it prevents any gainful activity, and we will retain the
current body mass index (BMI) criteria in listing 5.08 (Weight loss due
to any digestive disorder).
---------------------------------------------------------------------------

\66\ Becker, P., Carney, L.N., Corkins, M.R., Monczka, J.,
Smith, E., Smith, S.E., Spear, B.A., & White, J.V. (2015). Consensus
statement of the Academy of Nutrition and Dietetics/American Society
for Parenteral and Enteral Nutrition: Indicators recommended for the
identification and documentation of pediatric malnutrition
(undernutrition). Nutrition in Clinical Practice, 30(1), 147-161.
https://doi.org/10.1177/0884533614557642.
\67\ White, J.V., Guenter, P., Jensen, G., Malone, A., &
Schofield, M. (2012). Consensus statement: Academy of Nutrition and
Dietetics and American Society for Parenteral and Enteral Nutrition:
Characteristics recommended for the identification and documentation
of adult malnutrition (undernutrition). Journal of Parenteral and
Enteral Nutrition, 36(3), 275-283. https://doi.org/10.1177/0148607112440285.
\68\ Gounden, V., Vashisht, R., & Jialal, I. (2021).
Hypoalbuminemia. In StatPearls [internet]. StatPearls Publishing.
https://www.ncbi.nlm.nih.gov/books/NBK526080/.
\69\ National Heart Lung and Blood Institute. (2011). Your guide
to anemia (NIH Publication No. 11-7629). US Department of Health and
Human Services, National Institutes of Health. https://www.nhlbi.nih.gov/files/docs/public/blood/anemia-yg.pdf.
---------------------------------------------------------------------------

Likewise, consistent with the comments supporting the change from 6
months to 12 months, we kept the proposed revision in the final
language for listing 5.08 (Weight loss due to any digestive disorder)
to require the two BMI calculations to be within a consecutive 12-month
period. We made the appropriate related changes to the introductory
text, including 5.00A (Which digestive disorders do we evaluate in this
body system?), 5.00D (What is inflammatory bowel disease (IBD), and how
do we evaluate it under 5.06?), and 5.00F (How do we evaluate weight
loss due to any digestive disorder under 5.08?).
Because we are not finalizing our proposal to use laboratory values
such as hemoglobin or albumin in listing 5.08, we also retained current
5.06B1 (``Anemia'') and 5.06B2 (``Serum albumin''). We proposed to
remove them due to redundancy with the proposed criteria for 5.08
(Weight loss due to any digestive disorder). We also retained current
5.00E4 and 105.00E4 (``Surgical diversion of the intestinal tract'') as
5.00D3 and 105.00D3.
We did not adopt the suggestion to omit the words ``due to any
digestive disorder'' from listing 5.08 because we define digestive
disorders in 5.00A (Which digestive disorders do we evaluate in this
body system?) as disorders ``that result in severe dysfunction of the
liver, pancreas, and gastrointestinal tract.''
Comment: One commenter expressed concern about the proposed change
to listings 5.08 (Weight loss due to any digestive disorder) and 105.08
(Growth failure due to any digestive disorder) from a 6-month period
for the two data points (two BMI calculations) to a 12-month period,
because of the detrimental effects of malnutrition over time.
Response: We did not adopt the comment, because the commenter's
remarks seem to indicate a misunderstanding of our proposal. The
commenter seems to believe that the two data points must be taken 12
months apart, but we did not propose a requirement that the two data
points be taken 12 months apart. Our proposed requirement, finalized in
this final rule, specifies that the two measurements must both be taken
during a 12-month period and must be at least 60 days apart from one
another during the 12-month period.
Comment: One commenter asked that we consider a higher BMI
criterion, such as 20 or 22, for elderly patients under proposed
listing 5.08 (Weight loss due to any digestive disorder).
Response: We did not adopt this comment. We do not adjust BMI
calculations based on an adult person's

[[Page 37723]]

age.\70\ The disability program rules, including the listings, end at
full retirement age. If the person has not yet reached full retirement
age, we will consider age at a later step in the sequential evaluation
process, when we consider the person's residual functional capacity,
age, education, and work experience.\71\
---------------------------------------------------------------------------

\70\ Center for Disease Control. https://www.cdc.gov/healthyweight/assessing/bmi/adult_bmi/. The CDC does not
alter BMI calculations for adults 20 years and older.
\71\ 20 CFR 404.1520 and 416.920.
---------------------------------------------------------------------------

Comment: One commenter stated that listing 5.08 (Weight loss due to
any digestive disorder) does not specifically address eating disorders.
The commenter asked us to add language to the preamble (listing
introductory text) to clarify that adjudicators should utilize listing
12.13 (Eating disorders) to address eating disorders in listing 5.08
(Weight loss due to any digestive disorder).
Response: We adopted this comment. Listing 5.08 (Weight loss due to
any digestive disorder) is used to evaluate digestive disorders that
result in significant or serious weight loss. We define digestive
disorders in 5.00A (Which digestive disorders do we evaluate in this
body system?) as disorders ``that result in severe dysfunction of the
liver, pancreas, and gastrointestinal tract.'' However, severe,
listing-level weight loss can occur as a result of impairments other
than digestive disorders, such as due to certain genitourinary, immune,
or mental disorders. We have added language to the introductory text in
5.00F (How do we evaluate weight loss due to any digestive disorder
under 5.08?) and 105.00F (How do we evaluate growth failure due to any
digestive disorder under 105.08?) to provide adjudicators with guidance
on how to evaluate weight loss not caused by a digestive disorder.
Specifically, we explain that impairments other than digestive
disorders that cause weight loss should be evaluated under the
appropriate body system for that impairment. If the claimant develops a
digestive disorder as the result of another impairment, we will
evaluate the acquired digestive disorder under our rules for digestive
disorders.
Comment: One commenter recommended that malnutrition be included as
a causative factor for each of the digestive disorders, because it
results in functional impairments.
Response: We did not adopt this comment. We disagree with the
commenter's assertion that malnutrition is a causative factor for each
of the digestive disorders. For example, while increased malnutrition
risk is associated with IBD, it is not thought to cause
IBD.^{72 73}
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\72\ Schreiner, P., Martinho-Grueber, M., Studerus, D.,
Vavricka, S.R., Tilg, H., & Biedermann, L. (2020). Nutrition in
inflammatory bowel disease. Digestion, 101(Suppl. 1), 120-135.
https://doi.org/10.1159/000505368.
\73\ Ramos, G.P., & Papadakis, K.A. (2019). Mechanisms of
disease: Inflammatory bowel diseases. Mayo Clinic Proceedings,
94(1), 155-165. https://doi.org/10.1016/j.mayocp.2018.09.013.
---------------------------------------------------------------------------

Growth Failure
Comment: One commenter suggested that we define growth failure as
weight-for-height/length or BMI z-scores less than 2. Another commenter
requested that we use z-scores for single data points in listing 105.08
(Growth failure due to any digestive disorder). The commenter
recommended a z-score of <-1 for weight-for-height, BMI-for-age,
length/height for age, or mid-arm muscle circumference defining risk of
malnutrition and multiple z-score measurements over time demonstrating
a deceleration of weight for length/height diagnosing malnutrition. The
commenter also proposed looking at weight gain velocity, weight loss,
or inadequate nutrient intake to diagnose malnutrition.
Response: We did not adopt these comments. We did not propose to
change the requirements in listing 105.08 (Growth failure due to any
digestive disorder). Our long-standing policy is to use the third
percentile, going back to the inception of listing 105.08 (Growth
failure due to any digestive disorder) in 1977.\74\ As we explained in
the 2001 NPRM on which the current criteria are based, ``[t]he 3rd
percentile is generally accepted as the lower limit of the normal range
for most biologic measurements.'' \75\ A child whose weight is in the
3rd percentile weighs the same or more than 3 percent of the reference
population, and weighs less than 97 percent of the children in the
reference population. Percentiles are commonly used to assess the
growth of children in the United States. We are continuing our policy
that measurements below the third percentile correspond to listing-
level severity for children because the Centers for Disease Control and
Prevention (CDC) growth tables continues to provide percentiles.\76\
The tables included in 105.08 (Growth failure due to any digestive
disorder) are equivalent \77\ to the CDC growth tables.\78\ In the
development of these tables, the CDC elected to use the third
percentile as approximate to a z-score of -2, which is a standard
statistical cutoff point to determine the need for nutritional
intervention.\79\ The CDC explained that ``[p]ercentiles are the most
commonly used clinical indicator to assess the size and growth patterns
of individual children in the United States.'' \80\ The third
percentile on the CDC charts identifies the extremes of the
distribution and is referenced by pediatric endocrinologists and others
who assess the growth of children with special health care
requirements.\81\ The childhood listings describe impairments that
cause marked and severe functional limitations.\82\ Listing 105.08
(Growth failure due to any digestive disorder) specifically describes
growth failure due to a digestive disorder (such as malnutrition) that
is severe enough to meet this threshold. Listing 105.08 (Growth failure
due to any digestive disorder) is not intended to provide diagnostic
guidelines for such a disorder generally, or to help identify children
who may be at risk of a disorder.
---------------------------------------------------------------------------

\74\ 42 FR 14705, 14710 (1977).
\75\ 66 FR 57009, 57014 (2001).
\76\ 66 FR at 57021 (2001).
\77\ The values in our table are generally the same as those
used by the CDC, but we have rounded to the nearest tenth and
grouped same values into a single line on our table. For example:
Row 1 on the CDC table for boys age 2 is 14.50347667 and row 2 for
boys age 2.1 is 14.46882381. Both of these values round to 14.5, so
on the SSA table the value of 14.5 is given for boys age 2-2.1.
Furthermore, although the CDC table goes to age 20 for boys, we do
not use the values for age 18-20, because we do not use the
childhood listings for individuals 18 and older.
\78\ National Center for Health Studies. (2002, May). 2000 CDC
Growth Charts for the United States: Methods and Development. United
States Department of Health & Human Services https://www.cdc.gov/nchs/data/series/sr_11/sr11_246.pdf.
\79\ Id.
\80\ Id.
\81\ National Center for Health Studies. (2017, June). Clinical
Growth Charts. Centers for Disease Control and Prevention. https://www.cdc.gov/growthcharts/clinical_charts.htm.
\82\ 20 CFR 416.925.
---------------------------------------------------------------------------

Comment: One commenter stated that we did not provide adequate
justification for our selection of using the 3rd percentile values for
weight-for length and our selection of albumin and hemoglobin levels in
listing 105.08 (Growth failure due to any digestive disorder).
Response: The comment reflects a misunderstanding since we did not
propose to change the requirements in listing 105.08 (Growth failure
due to any digestive disorder). The text in this section of the listing
is unchanged, and identical to our existing regulatory text, but we
chose to republish it for the clarity and continuity of the listing as
a whole.

[[Page 37724]]

Other Digestive Disorders Comments
Comment: One commenter asked if we considered expanding the one-
year period for which we consider a person to be under a disability
following liver (5.09, 105.09 (Liver transplantation)), small intestine
(5.11, 105.11 (Small intestine transplantation)), or pancreas (5.12,
105.12 (Pancreas transplantation)) transplant, because post-transplant
follow-up, complications, or adverse effects of immunosuppression may
persist for longer than a year.
Response: We considered this comment and are not making any
changes. The one-year period of disability following liver, small
intestine, or pancreas transplant in these listings is consistent with
the listings for heart transplant (4.09 (Heart transplant)) and kidney
transplant (6.04 (Chronic kidney disease, with kidney transplant)).
Like other organ transplant recipients, liver transplant recipients are
at risk of developing post-transplant complications such as organ
rejection or infection. The risk of rejection is highest during the
first 3-6 months after transplantation and then decreases
significantly.\83\ Bacterial infections are most common within the
first month and viral infections generally occur within the first 6
months.\84\ Medical literature for liver transplant recipients
indicates that most transplant recipients are able to return to
activities of daily living and work within 12 months.\85\
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\83\ Manzarbeitia, C., & Arvelakis, A. (2019, January 11). Liver
transplantation treatment & management. Medscape. https://emedicine.medscape.com/article/431783-treatment.
\84\ Roayaie, K., & Feng, S. Liver transplant. University of
California San Francisco Transplant Surgery Department of Surgery.
https://transplantsurgery.ucsf.edu/conditions--procedures/liver-transplant.aspx.
\85\ Mayo Clinic Staff. (2020, July 15). Liver transplant. Mayo
Clinic. https://www.mayoclinic.org/tests-procedures/liver-transplant/about/pac-20384842.
---------------------------------------------------------------------------

We reevaluate the claim at the end of the one-year period, using
updated medical records and any other necessary information to
determine if there is continuing disability.\86\ Additionally, we do
not automatically cease benefits once the one-year period has
concluded. As we explain in 5.00G and 105.00G (How do we evaluate
digestive organ transplantation?), after the one-year period, we
evaluate the person's post-transplant function, the frequency and
severity of any rejection episodes, complications in other body
systems, and adverse treatment effects. A continuation or cessation of
disability depends on the evidence found in the medical record at the
time of reevaluation.\87\
---------------------------------------------------------------------------

\86\ See 5.00G and 105.00G (How do we evaluate digestive organ
transplantation?).
\87\ 20 CFR 404.1589 and 416.989.
---------------------------------------------------------------------------

Comment: One commenter suggested that we revise listing 105.10
(Need for supplemental daily enteral feeding via a gastrostomy) ``to
include tube feeding by nasogastric or nasojejunal tube feeding, or
gastrojejunostomy, as well as by gastrostomy.''
Response: We partially adopted this comment. We revised listing
105.10 (Need for supplemental daily enteral feeding via a gastrostomy)
to include tube feeding by jejunostomy or duodenostomy, as well as by
gastrostomy. We did not include nasogastric or nasojejunal tube
feeding. Nasogastric or nasojejunal tube feeding methods are likely to
be used for relatively short periods of time and would not meet the
durational requirement for disability.^{88 89} We also updated
the introductory text at 105.00H (How do we evaluate the need for
supplemental daily enteral feeding via a gastrostomy, duodenostomy, or
jejunostomy?) to reflect this additional language.
---------------------------------------------------------------------------

\88\ Yi, D.Y. (2018). Enteral nutrition in pediatric patients.
Pediatric Gastroenterology, Hepatology, & Nutrition, 21(1), 12-19.
https://doi.org/10.5223/pghn.2018.21.1.12.
\89\ 20 CFR 416.906 and 416.909.
---------------------------------------------------------------------------

Comment: One commenter asked that we ``clarify how pancreatic
disease would be identified since it is not included as a separate
listing.''
Response: We did not make any changes to this rule based on this
comment. We do not have a listing for every digestive disorder.
However, we evaluate unlisted digestive disorders under the sequential
evaluation process, as we explain in 5.00J and 105.00L (How do we
evaluate digestive disorders that do not meet one of these listings?).
We will first consider whether an impairment, such as pancreatic
disease, medically equals a listing. If the impairment(s) does not
medically equal the criteria of a listing, this does not mean that we
will deny the claim. If an adult's impairment(s) does not meet or
medically equal any listing, we may find that person disabled at a
later step in the sequential evaluation process.\90\ If a child's
impairment(s) does not meet or medically equal any listing, we may find
that their impairment(s) functionally equal the listings.\91\
---------------------------------------------------------------------------

\90\ 20 CFR 404.1520 and 416.920.
\91\ 20 CFR 416.924.
---------------------------------------------------------------------------

Comment: Several commenters asked us to add that a lack of opioid
or narcotic prescriptions or attempts to reduce or avoid use of such
medication should never be considered indicative of the severity of an
impairment, nor should it affect an adjudicator's decision about
whether an impairment can reasonably be expected to produce a person's
symptoms (including pain) or about the intensity and severity of such
symptoms.
Response: We did not adopt these comments. The disability program
rules require the presence of a medically determinable impairment that
can reasonably be expected to produce the symptoms (including pain).
Our adjudicators consider all evidence in the record when making this
finding, including a description of the person's medications and the
effects of those medications on the allegations of pain, as well as
factors such as the person's daily activities, the location, duration,
frequency, and intensity of their symptoms, treatment other than
medication, and any measures other than treatment that the person uses
to alleviate their symptoms, such as the need to change positions.\92\
If a person is prescribed any medication, including opioid or other
narcotic medication, and chooses to not take the medication, we use our
rules regarding the need to follow prescribed treatment, which apply to
all medical conditions, not just digestive disorders, and are explained
in 20 CFR 404.1530 and 416.930 (Need to follow prescribed treatment).
In conjunction with our regulations, we provide additional guidance on
following prescribed treatment in SSR 18-3p (Titles II and XVI: Failure
to Follow Prescribed Treatment), in which we include the ``risk of
addiction to opioid medication'' as an example of a ``good cause''
reason for not following prescribed treatment.'' \93\ As such, it is
already our policy that a lack of, or reduction of, opioid or narcotic
prescriptions due to the risk of addiction will not adversely affect a
person's claim during the adjudication process. Consequently, there is
no need to specify such within this specific medical listing.
---------------------------------------------------------------------------

\92\ 20 CFR 404.1529(c)(3), 416.929(c)(3), and Social Security
Ruling (SSR) 16-3p (2016). Available at: https://www.ssa.gov/OP_Home/rulings/di/01/SSR2016-03-di-01.html.
\93\ SSR 18-3p (2018). Available at: https://www.ssa.gov/OP_Home/rulings/di/02/SSR2018-03-di-02.html.
---------------------------------------------------------------------------

Comment: One commenter stated that we failed to provide evidence
that we considered the tolerance of employers when dealing with the
issues associated with digestive disorders (for example, diarrhea,
fecal incontinence, rectal bleeding, abdominal pain, fatigue, fever,
nausea, vomiting, and arthralgia).
Response: We did not make changes in response to the comment,
because we follow our statutory requirements. The

[[Page 37725]]

Act states a person shall be determined to be under a disability only
if the person is unable to do any substantial gainful activity,
regardless of whether an employer would hire them.\94\ The listings,
however, identify impairments we consider severe enough to prevent a
person from doing any gainful activity, regardless of the person's age,
education, or work experience.\95\ Consistent with the Act, we do not
consider whether employers may be unwilling to hire a person with a
particular impairment, such as a digestive disorder. Individual,
employer-specific policies vary in scope and so are not appropriate for
our national program, which uses a definition of disability that can be
uniformly applied throughout the nation. We will consider the effects
of an individual's resulting symptoms from their medically determinable
digestive disorders, such as those identified by the commenter when we
assess and consider the individual's residual functional capacity at
later steps in our sequential evaluation process.\96\
---------------------------------------------------------------------------

\94\ 42 U.S.C. 423(d)(2)(A) and 42 U.S.C. 1382c(a)(3)(B).
\95\ 20 CFR 404.1525 and 20 CFR 416.925.
\96\ 20 CFR 404.1520 and 20 CFR 416.920.
---------------------------------------------------------------------------

Skin Disorders

Comment: Several commenters asked that we add wheeled mobility
devices, specifically wheelchairs, adaptive or special needs strollers,
and scooters, to our definition of ``assistive device(s)'' in 8.00B1
and 108.00B1 (Assistive device(s)).\97\ The commenters also noted that
while the wheeled mobility devices they requested are not hand-held or
worn, they improve stability and mobility, and stated claimants with a
documented medical need for these devices have functional limitations
at least as significant to those with a need for other assistive
devices.
---------------------------------------------------------------------------

\97\ We note that the commenters referenced 8.00B2 and 108.00B2
(Chronic skin lesions), which is not correct. The correct reference
for the definition of ``assistive device(s)'' for this comment is
8.00B1 and 108.00B1 (Assistive device(s)).
---------------------------------------------------------------------------

Response: We generally adopted these comments, specifying
alternative examples. We incorporated devices used in a seated position
into the definition of assistive device(s) in 8.00B1 and 108.00B1
(Assistive device(s)). Rather than using the suggested examples of
``wheelchairs, adaptive or special needs strollers, and scooters,'' we
used examples such as wheelchair, rollator, and power operated vehicle.
We chose these examples because the National Academies of Sciences,
Engineering, and Medicine described these types of wheeled and seated
mobility devices in a consensus study report on assistive
technology.\98\ This change is also consistent with the definition of
``assistive device(s)'' used in the recently published final rule,
Revised Medical Criteria for Evaluating Musculoskeletal Disorders.\99\
---------------------------------------------------------------------------

\98\ National Academies of Sciences, Engineering, and Medicine.
(2017). The promise of assistive technology to enhance activity and
work participation. The National Academies Press. https://doi.org/10.17226/24740.
\99\ 85 FR 78164 (2020).
---------------------------------------------------------------------------

Comment: Several commenters stated that the definition of ``fine
and gross movements'' in 8.00B5 and 108.00B5 (Fine and gross movements)
should include ``feeling'' as a fine movement, in keeping with SSR 85-
15 (Titles II and XVI: Capability to Do Other Work--The Medical-
Vocational Rules as a Framework for Evaluating Solely Nonexertional
Impairments.) \100\ In addition, a commenter also referenced SSR 09-6p
(Title XVI: Determining Childhood Disability--The Functional
Equivalence Domain of ``Moving About and Manipulating Objects.'') \101\
---------------------------------------------------------------------------

\100\ SSR 85-15 (1985). Available at: https://www.ssa.gov/OP_Home/rulings/di/02/SSR85-15-di-02.html.
\101\ SSR 09-6p (2009). Available at: https://www.ssa.gov/OP_Home/rulings/ssi/02/SSR2009-06-ssi-02.html.
---------------------------------------------------------------------------

Response: We disagree with the comments and did not adopt the
suggestion. SSR 85-15 (Titles II and XVI: Capability to Do Other Work--
The Medical-Vocational Rules as a Framework for Evaluating Solely
Nonexertional Impairments) provides guidance to our adjudicators on the
capability to do other work, applicable at step 5 of the sequential
evaluation process; it is therefore not within the scope of this final
rule, which addresses the listings step of the sequential evaluation
process. With regard to SSR 09-6p (Title XVI: Determining Childhood
Disability--The Functional Equivalence Domain of ``Moving About and
Manipulating Objects''), this SSR is consolidated guidance for our
adjudicators for evaluating the functional equivalence domain of moving
about and manipulating objects for children, which is also not within
the scope of this final rule. While these SSRs are not within the scope
of this final rule, we note that SSR 09-6p (Title XVI: Determining
Childhood Disability--The Functional Equivalence Domain of ``Moving
About and Manipulating Objects'') does not specifically mention feeling
in regard to fine and gross movements, only that sensory loss that
interferes with motor activities is a limitation we consider under the
domain of ``moving about and manipulating objects.'' Moreover, SSR 85-
15 (Titles II and XVI: Capability to Do Other Work--The Medical-
Vocational Rules as a Framework for Evaluating Solely Nonexertional
Impairments) discusses ``feeling'' as a manipulative impairment, not as
a fine movement as the commenter implies. However, if the claimant's
skin condition causes limitations in their ability to feel, which also
results in significant deficits in their ability to perform fine and
gross movements as defined in 8.00B5 and 108.00B5 (Fine and gross
movements), their skin condition may be found to meet the listing
criteria. If the evidence does not support a finding that the
claimant's skin condition meets a listing, any additional impact of the
claimant's loss of ability to feel due to a skin condition would be
evaluated under our medical equivalence rules (as well as our
functional equivalence rules for child claimants) at step 3 of the
sequential evaluation, or at steps 4 and 5 of the sequential evaluation
process for adult claimants.\102\
---------------------------------------------------------------------------

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

Comment: Several commenters stated that it was unclear why proposed
sections 8.00C3d and 108.00C3d (What evidence do we need to evaluate
your skin disorder?) require information about the claimant's ``history
of familial incidence'' of a skin impairment.\103\ They asserted that
the information may be unobtainable (for example, family members may be
absent, deceased, not receiving medical treatment, or reluctant to
share medical information), and the history does not affect the
claimant's level of functioning.
---------------------------------------------------------------------------

\103\ 84 FR at 35948, 35956 (2019).
---------------------------------------------------------------------------

Response: Our changes only reorganized the current guidance into an
outline format for easier reading; we did not propose new requirements.
Additionally, our guidance in 8.00B and 108.08B (What documentation do
we need?) applies to the entirety of the skin listings, and as we state
in 8.00A and 108.00A (Which skin disorders do we evaluate under these
listings?) of the current rules, we evaluate skin disorders that result
from hereditary, congenital, or acquired pathological processes.
Therefore, a history of familial incidence, when available, may help us
in evaluating hereditary skin disorders. For example, for many
inherited skin disorders, we consider a family history as key
information in helping establish a medically determinable

[[Page 37726]]

impairment.\104\ Additionally, other conditions, such as atopic
dermatitis, have a high familial occurrence, and therefore a family
history is useful information in establishing the presence of a
medically determinable impairment.\105\ However, for other skin
conditions, including acquired conditions such as burn injuries, a
familial history is less relevant, and we would not seek information on
familial incidence in those cases. Nevertheless, we made minor changes
in response to this comment, and acknowledge some claimants will not
have a history of familial incidence or access to adequate or any
health information about genetic relatives. While familial incidence is
useful, we will use other available information and medical evidence to
establish the medically determinable impairment in instances where it
is not available.
---------------------------------------------------------------------------

\104\ Tantcheva-Poor, I., Oji, V., & Has, C. (2016) A multistep
approach to the diagnosis of rare genodermatoses. Journal of the
German Society of Dermatology, 14(10), 969-986. https://doi.org/10.1111/ddg.13140.
\105\ DeStefano, G.M., & Christiano, A.M. (2014) The genetics of
human skin disease. Cold Spring Harbor Perspectives in Medicine,
4(10), a015172. https://doi.org/10.1101/cshperspect.a015172.
---------------------------------------------------------------------------

We modified 8.00C3 and 108.00C3 (What evidence do we need to
evaluate your skin disorder?) and its subparagraphs. In this final
rule, we split the requirements from proposed 8.00C3d and 108.00C3d
(``Your history of familial incidence; exposure to toxins, allergens or
irritants; seasonal variations; and stress factors'') into two
paragraphs, and we revised our wording about history of familial
incidence to ``Any available history of familial incidence'' in final
8.00C3d and 108.00C3d (``Any available history of familial
incidence''). We inserted ``Your exposure to toxins, allergens, or
irritants; seasonal variations; and stress factors'' into final 8.00C3e
(``Your exposure to toxins, allergens or irritants; seasonal
variations; and stress factors'') and 108.00C3e (``Your exposure to
toxins, allergens or irritants; seasonal variations; and stress
factors'').
We relettered subparagraphs 8.00C3e and 108.00C3e (``Your ability
to function outside of a highly protective environment'') through
8.00C3h and 108.00C3h (``Statements you or others make about your
disorder(s), your restrictions, and your daily activities'') to 8.00C3f
through 8.00C3i and 108.00C3f through 108.00C3i, respectively.
Comment: Several commenters asked that we omit the word
``prescribed'' from 8.00D (How do we evaluate the severity of skin
disorders?) because some medically necessary treatments recommended by
medical providers for skin conditions (for example, medicated baths,
frequent bandage changes, or over-the-counter ointments) do not require
a prescription. The commenters believe that this change would better
align with the statement in 8.00B4 (Documented medical need) that
assistive devices do not need to be prescribed in order to be
considered by adjudicators.
Response: We have partially accepted this comment. As the
commenters note, and as is consistent with our other regulations,
medical providers other than physicians may ``prescribe'' or recommend
treatment. To acknowledge this, we are changing the term ``physician''
in 8.00D5b and 108.00d5b (Despite adherence to prescribed medical
treatment for 3 months) to ``medical source'' to account for the types
of treatments identified by the commenters above.\106\ As defined in
our regulations, a ``medical source'' means an individual who is
licensed as a healthcare worker by a State and working within the scope
of practice permitted under State or Federal law, or an individual who
is certified by a State as a speech-language pathologist or a school
psychologist and acting within the scope of practice permitted under
State or Federal law.\107\ Prescribed medical treatment means that a
medical source has instructed the patient to adhere to a specified
treatment, such as any medication, surgery, therapy, the use of durable
medical equipment, or the use of assistive devices. Prescribed
treatment does not include lifestyle modifications, such as dieting,
exercise, or smoking cessation. We will consider any evidence of
prescribed treatment, whether it appears on prescription forms or is
otherwise indicated within a medical source's records. An assistive
device(s), as explained in 8.00B and 108.00B (What are our definitions
for the following terms used in this body system?) of this final rule,
is not a treatment method for a skin disorder. An assistive device(s)
is any device used to improve stability, dexterity, or mobility, and
does not need to be prescribed for adjudicators to consider its use as
long as there is a documented medical need for the assistive device.
---------------------------------------------------------------------------

\106\ 20 CFR 404.1502(d) and 416.902(i).
\107\ Id.
---------------------------------------------------------------------------

Comment: A few commenters stated that proposed 8.00D6b (``If, for
any reason, you have not received treatment'') \108\ is contrary to the
``spirit'' of SSR 18-3p (Titles II and XVI: Failure to Follow
Prescribed Treatment).\109\ The commenters added that SSR 18-3p
provides ``several reasons (including religion, inability to pay,
incapacity, intense fear of surgery, risk of opioid addiction, etc.)
why noncompliance with prescribed medicine could be excused.'' The
commenters state that the same exceptions for excusing medical
treatment compliance might be the same reasons why a person has not
received treatment. The commenters recommended that if we do not remove
proposed 8.00D6b (``If, for any reason, you have not received
treatment''), we should state that the reasons from SSR 18-3p are
reasons a skin disorder could meet listing 8.09 (Chronic conditions of
the skin or mucous membranes) without evidence of treatment.
---------------------------------------------------------------------------

\108\ Paragraph 8.00D6b (``If, for any reason, you have not
received treatment'') of the proposed and final rule states in part,
``If, for any reason, you have not received treatment, your skin
disorder cannot meet the criteria for 8.09.''
\109\ 83 FR 49616 (2018) and SSR 18-3p (2018). Available at:
https://www.ssa.gov/OP_Home/rulings/di/02/SSR2018-03-di-02.html.
---------------------------------------------------------------------------

Response: We did not adopt these comments. The commenters
misunderstand our policy for failure to follow prescribed treatment in
this instance. We only consider our failure to follow prescribed
treatment policy and procedures after determining that a person is
entitled to disability benefits. Once we determine that a person is
entitled to disability benefits, we determine whether the evidence
indicates that the person might not have been entitled to disability
benefits if they had followed prescribed treatment. Therefore, in the
case of listing 8.09 (Chronic conditions of the skin or mucous
membranes), before we make a failure to follow prescribed treatment
determination, we first need to determine that a person's skin disorder
meets all of our criteria for listing 8.09 (Chronic conditions of the
skin or mucous membranes), including listing criteria related to
treatment. In the introductory text at 8.00D5b (Despite adherence to
prescribed medical treatment for 3 months) we state that under listing
8.09 (Chronic conditions of the skin or mucous membranes), we require
that a person's symptoms persist ``despite adherence to prescribed
treatment for 3 months.'' The adherence to prescribed treatment is a
part of the listing criteria and must be present in order for a
person's skin condition to meet the criteria of the listing. Therefore,
it is not possible to find a person disabled under listing 8.09
(Chronic conditions of the skin or mucous membranes) without a record
of prescribed treatment, which is further explained in paragraph
8.00D6b (``If, for

[[Page 37727]]

any reason, you have not received treatment''). This is clarified by
our guidance in SSR 18-3p (Titles II and XVI: Failure to Follow
Prescribed Treatment), where we explain that a failure to follow
prescribed treatment determination is not applicable when a listed
impairment(s) requires us to consider whether a person was following a
specific treatment as part of satisfying the listing analysis.
Moreover, the requirement for prescribed treatment for skin
disorders dates back to 1979.\110\ We last comprehensively revised the
listings for evaluating skin disorders in 2004. In the preamble to that
final rule, we explained that the original requirement for extensive
lesions ``not responding to prescribed treatment'' was replaced with
the more specific requirement that there be ``extensive skin lesions
that persist for at least 3 months despite continuing treatment as
prescribed.'' \111\ We are retaining that requirement with this update;
however, with this final rule, we are finalizing our proposal to change
the language to ``despite adherence to prescribed medical treatment''
to be more consistent with current medical terminology.
---------------------------------------------------------------------------

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

Additionally, we do not deny a claim if a person does not have an
impairment that meets a listing. We may find the impairment(s)
medically equals a listing (or, in the case of a child seeking
Supplemental Security Income (SSI) payments, functionally equals the
listings). If an adult claimant's impairment(s) does not meet or
medically equal any listing, we may find them disabled at a later step
in the sequential evaluation process. A lack of treatment history, as a
solitary factor, does not require us to deny a claim. We evaluate a
claim, including all record evidence, regardless of whether a person
has received treatment for their impairment(s).
Comment: Several commenters asked us not to finalize the proposed
changes to the functional criteria because the changes we propose to
the skin disorders listings are ``more onerous,'' and they assert that
fewer applicants will qualify for disability based on these updated
criteria. These commenters believed the updates would prolong the
process of applying for disability by necessitating assessment at later
steps in the sequential evaluation process and would require vocational
information and consideration of a person's age, education, and work
experience, to make a determination. The commenters also expressed
concern that these updates will ultimately result in more denials of
claims at the initial and reconsideration levels. For instance, the
commenters suggested that a person's skin disorder would be unable to
meet a skin disorders listing if only one side of a groin and an axilla
(underarm) was involved instead of both sides of the groin or the
axillae (underarms).
Response: We did not adopt these comments. The requirement that the
claimant's skin disorder results in significant functional limitations
lasting a minimum of 12 months despite adherence to treatment dates
back to 1979.\112\ The introductory text to our 1979 final rule stated
that the claimant's skin lesions ``must be shown to have persisted for
a sufficient period of time despite therapy for a reasonable
presumption to be made that severe impairment will last for a
continuous period of at least 12 months.'' \113\ This is a requirement
in our current rule as well, which states that we require evidence that
the claimant's skin disorder results in a degree of functional
limitation such that the claimant is ``unable to do any gainful
activity for a continuous period of at least 12 months'' (see current
8.00C2 and 108.00C2 (Frequency of flare-ups)). The language in the
final rule reflects a continuation of this requirement, stating that we
must have medically documented evidence of physical limitation(s) of
functioning related to the claimant's skin disorder, and that the
decrease in physical function resulting from the claimant's skin
disorder must have lasted, or can be expected to last, for a continuous
period of at least 12 months (8.00D2 and 108.00D2 (Limitation(s) of
physical functioning due to skin disorders). Further, this is
consistent with our program-wide rules for the Listing of Impairments,
which identify impairments that preclude the ability to perform any
gainful activity (or, in the case of a child applying for SSI payments
based on disability, which identify impairments that result in marked
and severe functional limitations) and have lasted or can be expected
to last for a continuous period of at least 12 months.\114\
---------------------------------------------------------------------------

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

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

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

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

[[Page 37728]]

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

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

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

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

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

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

As for the commenter's assertion that the revised skin listings are
confusing and more complicated to read, we addressed the commenter's
concerns by revising the language in 8.07B2 and 108.07B2 (``Chronic
skin lesions or contractures''), 8.08 and 108.08 (Burns), and 8.09 and
108.09 (Chronic conditions of the skin or mucous membranes), to improve
the clarity and readability of these listings. Specifically, we removed
repetitive language related to impairment-related limitations. In
addition to revising the language in these listings to make the
criteria easier to understand and apply, we moved the 8.00D2 and
108.00D2 (Limitation(s) of physical functioning due to skin disorders)
cross references from 8.09A to 8.09B and from 108.09A to 108.09B,
respectively, to align with the terms they describe. We did not make
any other changes to the cross references. Regarding the use of cross
references in revised listing 8.09 (Chronic conditions of the skin or
mucous membranes), we use cross references throughout the listings for
body systems to assist adjudicators, advocates, and lay people with
understanding and locating terms

[[Page 37729]]

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

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

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

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

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

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

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

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

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

[[Page 37730]]

from different body systems far exceeds the number of disorders in any
single body system. For example, if there are 100 different digestive
disorders and 100 different skin disorders, there are 10,000
combinations of digestive and skin disorders. The commenter added that
our proposed listings only include single disorders and leave out many
important combinations of disorders. The commenter stated that we have
only covered a tiny fraction of the possible disorders two at a time.
The commenter alleged that proposed listings discriminate in favor of
those with severe single body system disorders and against those with
combinations of disorders.
Response: We did not adopt this comment. We recognize that
digestive disorders and skin disorders may co-occur with impairments in
other body systems. In some cases, the impairment in another body
system results from a digestive disorder or a skin disorder. In other
cases, the impairment in another body system is not related to the
digestive disorder or the skin disorder. We intend the listings for
digestive disorders to address digestive disorders and the
complications of those disorders. We intend the listings for skin
disorders to address skin disorders and the complications of those
disorders. When the co-occurring condition or complication is due to a
digestive disorder or skin disorder, we evaluate it under the digestive
disorders listings or skin disorders listings, as appropriate. However,
when the co-occurring impairments are unrelated, we evaluate the
combination under our medical equivalence rules (as well as our
functional equivalence rules for child claimants) at step 3 of the
sequential evaluation, or at steps 4 and 5 of the sequential evaluation
process for adult claimants. We evaluate unrelated co-occurring
impairments at these steps because adjudicators can account for
specific combinations of impairments, complications of those
impairments, and limitations of functioning on an individual case
basis. We address this in the introductory text of the digestive
disorders listings at 5.00J and 105.00L (How do we evaluate digestive
disorders that do not meet one of these listings?) and in the
introductory text of the skin disorders listings at 8.00I and 108.00I
(How do we evaluate skin disorders that do not meet one of these
listings?).

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

Under the Act, we have authority to make rules and regulations and
to establish necessary and appropriate procedures to carry out such
provisions.\132\
---------------------------------------------------------------------------

\132\ See sections 205(a), 702(a)(5), and 1631(d)(1) (42 U.S.C.
405(a), 902(a)(5), 1383(d)(1)).
---------------------------------------------------------------------------

How long will this final rule be in effect?

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

How we will implement this final rule?

We will begin to apply this final rule to new applications, pending
claims, and continuing disability reviews (CDR), as appropriate, as of
the effective date of this final rule.\133\
---------------------------------------------------------------------------

\133\ We will use the final rule beginning on its effective
date. We will apply the final rule to new applications filed on or
after the effective date, and to claims that are pending on and
after the effective date. This means that we will use the final rule
on and after its effective date in any case in which we make a
determination or decision, including CDRs, as appropriate. See 20
CFR 404.902 and 416.1402.
---------------------------------------------------------------------------

Regulatory Procedures

Executive Order 12866, as Supplemented by Executive Order 13563

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

Anticipated Costs to Our Programs

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

[[Page 37731]]

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

Anticipated Administrative Costs to the Social Security Administration

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

Anticipated Costs to the Public

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

Congressional Review Act

This final rule is not a major rule as defined by the Congressional
Review Act.\134\
---------------------------------------------------------------------------

\134\ 5 U.S.C. 801 et seq.
---------------------------------------------------------------------------

Executive Order 13132 (Federalism)

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

Regulatory Flexibility Act

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

Paperwork Reduction Act

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

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

List of Subjects

20 CFR Part 404

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

20 CFR Part 416

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

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

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

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

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

Subpart P--Determining Disability and Blindness

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

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

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

[[Page 37732]]

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

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

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

Part A

* * * * *

Sec.

* * * * *

5.00 Digestive Disorders

* * * * *

5.00 Digestive Disorders

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

[[Page 37733]]

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

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

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

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

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

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

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

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

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

[[Page 37734]]

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

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

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

[[Page 37735]]

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

B. Ascites or hydrothorax not attributable to other causes (see
5.00C2b), present on two evaluations within a consecutive 12-month
period and at least 60 days apart. Each evaluation must document the
ascites or hydrothorax by 1, 2, or 3:
1. Paracentesis; or
2. Thoracentesis; or
3. Imaging or physical examination with a or b:
a. Serum albumin of 3.0 g/dL or less; or
b. INR of at least 1.5.

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

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

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

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

G. Two SSA CLD scores (see 5.00C3) of at least 20 within a
consecutive 12-month period and at least 60 days apart. Consider
under a disability from at least the date of the first score.
5.06 Inflammatory bowel disease (IBD) (see 5.00D) documented by
endoscopy, biopsy, imaging, or operative findings, and demonstrated
by A, B, or C:
A. Obstruction of stenotic areas (not adhesions) in the small
intestine or colon with proximal dilatation, confirmed by imaging or
in surgery, requiring two hospitalizations for intestinal
decompression or for surgery, within a consecutive 12-month period
and at least 60 days apart.

B. Two of the following occurring within a consecutive 12-month
period and at least 60 days apart:
1. Anemia with hemoglobin of less than 10.0 g/dL, present on at
least two evaluations at least 60 days apart; or
2. Serum albumin of 3.0 g/dL or less, present on at least two
evaluations at least 60 days apart; or
3. Clinically documented tender abdominal mass palpable on
physical examination with abdominal pain or cramping; or
4. Perianal disease with a draining abscess or fistula; or
5. Need for supplemental daily enteral nutrition via a
gastrostomy, duodenostomy, or jejunostomy, or daily parenteral
nutrition via a central venous catheter.

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

6.00 Genitourinary Disorders

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

8.00 Skin Disorders

[[Page 37736]]

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

[[Page 37737]]

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

[[Page 37738]]

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

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

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

C. Inability to stand up from a seated position and maintain an
upright position to the extent needed to independently initiate,
sustain, and complete work-related activities due to chronic skin
lesions (see 8.00B2) or contractures (see 8.00B3) affecting at least
two extremities (including when the limitations are due to
involvement of the perineum or the inguinal region).

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

AND

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

14.00 Immune System Disorders

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

Part B

* * * * *

Sec.

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

100.00 Low Birth Weight and Failure to Thrive

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

[[Page 37739]]

103.00 Respiratory Disorders

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

104.00 Cardiovascular System

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

105.00 Digestive Disorders

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

[[Page 37740]]

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

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

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

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

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

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

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

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

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

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

[[Page 37741]]

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

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

[[Page 37742]]

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

B. Ascites or hydrothorax not attributable to other causes (see
105.00C2b), present on two evaluations within a consecutive 12-month
period and at least 60 days apart. Each evaluation must document the
ascites or hydrothorax by 1, 2, or 3:
1. Paracentesis; or
2. Thoracentesis; or
3. Imaging or physical examination with a or b:
a. Serum albumin of 3.0 g/dL or less; or
b. INR of at least 1.5.

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

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

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

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

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

H. Extrahepatic biliary atresia as diagnosed on liver biopsy or
intraoperative cholangiogram (see 105.00C4). Consider under a
disability for 1 year following diagnosis; after that, evaluate the
residual impairment(s).
105.06 Inflammatory bowel disease (IBD) (see 105.00D) documented
by endoscopy, biopsy, imaging, or operative findings and
demonstrated by A or B:
A. Obstruction of stenotic areas (not adhesions) in the small
intestine or colon with proximal dilatation, confirmed by imaging or
in surgery, requiring two hospitalizations for intestinal
decompression or for surgery, within a consecutive 12-month period
and at least 60 days apart.

B. Two of the following occurring within a consecutive 12-month
period and at least 60 days apart:
1. Anemia with hemoglobin less than 10.0 g/dL, present on at
least two evaluations at least 60 days apart; or
2. Serum albumin of 3.0 g/dL or less, present on at least two
evaluations at least 60 days apart; or
3. Clinically documented tender abdominal mass palpable on
physical examination with abdominal pain or cramping; or
4. Perianal disease with a draining abscess or fistula; or
5. Need for supplemental daily enteral nutrition via a
gastrostomy, duodenostomy, or jejunostomy, or daily parenteral
nutrition via a central venous catheter (see 105.10 for children who
have not attained age 3).
105.07 Intestinal failure (see 105.00E) due to short bowel
syndrome, chronic motility disorders, or extensive small bowel
mucosal disease, resulting in dependence on daily parenteral
nutrition via a central venous catheter for at least 12 months.
105.08 Growth failure due to any digestive disorder (see
105.00F), documented by A and B:
A. Chronic nutritional deficiency present on two evaluations
within a consecutive 12-month period and at least 60 days apart
documented by 1 or 2:
1. Anemia with hemoglobin less than 10.0 g/dL; or
2. Serum albumin of 3.0 g/dL or less.

AND

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

[[Page 37743]]

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

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

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

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

[[Page 37744]]

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

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

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

106.00 Genitourinary Disorders

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

108.00 Skin Disorders

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

[[Page 37745]]

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

[[Page 37746]]

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

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

[[Page 37747]]

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

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

C. Inability to stand up from a seated position and maintain an
upright position to the extent needed to independently initiate,
sustain, and complete age-appropriate activities due to chronic skin
lesions (see 108.00B2) or contractures (see 108.00B3) affecting at
least two extremities (including when the limitations are due to
involvement of the perineum or the inguinal region).

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

AND

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

114.00 Immune System Disorders

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

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