Why are we revising the listings for digestive disorders?

We reviewed the prior digestive disorder listings and determined that they should be revised in light of our program experience and advances in medical knowledge, methods of evaluating digestive disorders, and treatment. We last published final rules comprehensively revising the digestive disorder listings in the Federal Register on December 6, 1985 (50 FR 50068). In the introductory text to those rules, we stated our intention to periodically review and update these listings due to medical advances in treatment and our program experience.

What do we mean by ``final rules'' and ``prior rules''?

Even though these rules will not go into effect until 60 days after publication of this notice, for clarity we refer to the changes we are making here as the ``final rules'' and to the rules that will be changed by these final rules as the ``prior rules.''

When will we start to use these final rules?

We will start to use these final rules on their effective date. We will continue to use our prior rules until the effective date of these final rules. When these final rules become effective, we will apply them to new applications filed on or after the effective date of these rules and to claims pending before us, as we describe below.

As is our usual practice when we make changes to our regulations, we will apply these final rules on or after their effective date when we make a determination or decision, including those claims in which we make a determination or decision after a remand to us from a Federal court. With respect to claims in which we have made a final decision and that are pending judicial review in Federal court, we expect that the court would review the Commissioner's final decision in accordance with the rules in effect at the time the final decision of the Commissioner was issued. If a court reverses the Commissioner's final decision and remands the case for further administrative proceedings after the effective date of these final rules, we will apply the provisions of these final rules to the entire period at issue in the claim in our new decision issued pursuant to the court's remand. How long will these rules be in effect?

These rules will be in effect for 5 years after the date they become effective, unless we extend them or revise and issue them again. What general changes are we making that affect both the adult and childhood listings for digestive disorders?

We are clarifying the listing criteria and making them easier to use by:

We discuss other changes in the listings below, in our detailed explanation of the revised listings.
How are we changing the introductory text to the listings for evaluating digestive disorders in adults?

5.00 Digestive System

We are revising the introductory text for this body system to provide additional guidance for evaluating digestive disorders and to update its medical terminology. We are also removing references to digestive disorders and complications of digestive disorders, such as peptic ulcer disease, fistulae, and abscesses, that generally are not of listinglevel severity. (However, as we explain below, we are including fistulae and abscesses as criteria in final listing 5.06 for inflammatory bowel disease.)

We are including relevant material from prior 5.00A in final 5.00A and final 5.00C.

We are updating and moving relevant material from prior 5.00B to final 5.00G.

We are moving relevant material from prior 5.00C to final 5.00E. We are removing the portion of prior 5.00C that dealt with peptic ulcer disease because advances in diagnosis, evaluation, and treatment of this impairment make the surgical interventions discussed in the prior section (including gastrectomy, vagotomy, and pyloroplasty) much less common.

Following is a detailed, sectionbysection explanation of the final introductory text material.
5.00AWhat kinds of disorders do we consider in the digestive system?

This section revises prior 5.00A. We list the major types of digestive disorders included in these listings and provide an example of a complication that may result from them. In the NPRM, we proposed to include information in this section from prior 5.00C about colostomy and ileostomy. However, we moved this information to final 5.00E as part of the general reorganization of the introductory text. We also proposed to explain that gastrointestinal impairments frequently respond to treatment; therefore, their severity should be evaluated in the context of prescribed treatment. We moved this information to 5.00C, ``How do we consider the effects of treatment?'' where it more logically fits.

5.00BWhat documentation do we need?

In this new section, we include examples of the types of clinical and laboratory findings that should be part of the longitudinal evidence. This section also includes two sentences describing appropriate medically acceptable imaging that were not in the NPRM, but that we added in the aforementioned final rules making technical, but not policy, changes to our listings. We revised the sentence describing medically acceptable imaging so that it more appropriately reflects imaging techniques used for digestive disorders. We also moved to this section a revised version of the first sentence of proposed 5.00C2, which explains that the specific findings required by these listings must occur within the period we are considering in connection with an individual's application or continuing disability review.

In response to public comments we describe later in this preamble, we removed the sentence in proposed 5.00B1 explaining that we usually need longitudinal evidence covering a period of at least 6 months of observations and treatment unless we can make a fully favorable determination or decision without it. Instead, we are providing timeframes for the evidence requirements in each listing.

We moved proposed 5.00B2, which explained how we evaluate claims when an individual has not received ongoing treatment or does not have an ongoing relationship with the medical community despite the existence of a severe impairment, to final 5.00C where it fits more logically with our discussion of treatment issues.

5.00CHow do we consider the effects of treatment?

In the NPRM, proposed 5.00C was titled, ``How do we evaluate digestive disorders that require recurring or persistent findings?'' Proposed 5.00C1 defined ``recurring'' and ``persisting'' as used in listings 5.02, 5.05, 5.06, and 5.08, and proposed 5.00C2 explained when the ``events'' required to satisfy the listings must occur. In these final rules, we removed the references to recurring or persistent findings from the digestive listings. We also moved the first sentence of 5.00C2 to final 5.00B. We no longer need the second sentence of proposed 5.00C2 because of changes we made to the listings. Therefore, we removed all of proposed 5.00C. We explain the reasons for the changes to the listings later in this preamble.

We explain how we consider the effects of treatment in final 5.00C. This section is an expansion of proposed 5.00D. It includes six paragraphs that address treatment issues, rather than the three paragraphs we proposed. As we have already noted, we moved the additional paragraphs from other sections to present the information more logically.

General Information About Final 5.00D Through 5.00G

In the NPRM, proposed 5.00F was titled ``What are our guidelines for evaluating specific digestive impairments?'' Proposed 5.00F1 addressed malnutrition and weight loss, and proposed 5.00F2 addressed chronic liver disease. In these final rules, we are greatly expanding the introductory text from the NPRM in response to public comments and adding more discussion about digestive disorders, especially chronic liver disease and inflammatory bowel disease. Since we are including significantly more information in these final rules, we are addressing each kind of digestive disorder in its own separate section. Also, the guidance about specific disorders under proposed 5.00F was not in the order of the proposed listings. In the final rules, we are providing guidance that generally follows the structure of the final listings. Thus:

5.00DHow do we evaluate chronic liver disease?

In final 5.00D (proposed 5.00F2), we define chronic liver disease, provide examples of it, and describe its manifestations. In response to hundreds of public comments regarding hepatitis C, we are greatly expanding this section to explain how we evaluate chronic viral hepatitis, including chronic hepatitis B and C infections, and we describe extrahepatic manifestations of these infections. In addition, we include guidance for considering the effects of specific treatment modalities for hepatitis B and C infections. We also present information on conditions that we include in the chronic liver disease listing (that is, gastrointestinal
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hemorrhage, ascites or hydrothorax, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatopulmonary syndrome, hepatic encephalopathy, end stage liver disease, and liver transplantation).

Final 5.00D contains 12 sections:

In response to a comment, we are including guidance in final 5.00D3a to explain that symptoms may correlate poorly with the severity of chronic liver disease.

In final 5.00D3c, we are clarifying our intent in proposed 5.00F2d, where we explained that abnormal liver function test findings may correlate poorly with the clinical severity of liver disease. Although that guidance is applicable to liver function tests such as serum total bilirubin or liver enzyme levels, it is not applicable to all tests indicative of liver function. In final 5.00D3c, we now explain that abnormally low serum albumin or elevated International Normalized Ratio (INR) levels are exceptions because they are indicators of significant liver disease. As we note below, we include criteria for abnormally low serum albumin and elevated INR in final listings 5.05B and 5.05F.

We are also not including the statement from proposed 5.00F2d that liver function tests ``must not be relied upon in isolation'' because it is unnecessary. In final 5.00D3c, we are also expanding the rules from what we had proposed to include information on documenting chronic liver disease with a liver biopsy or imaging studies.

We also removed the statement in proposed 5.00F2d that current imaging techniques are capable of identifying even minimal amounts of ascites before they can be detected on physical examination. We made this change because final listing 5.05B is met based on laboratory findings coupled with documentation of the ascites or hydrothorax. If these laboratory findings are at the level specified in the listing, it is not necessary to quantify the ascites.

5.00EHow do we evaluate inflammatory bowel disease (IBD)?

In response to public comments, we are greatly expanding the listing criteria for inflammatory bowel disease, final listing 5.06, and adding a new section, final 5.00E, to the introductory text to provide guidance for evaluating IBD under these expanded criteria.

Final 5.00E contains four paragraphs:

5.00FHow do we evaluate short bowel syndrome (SBS)?

In response to public comments, we are adding a new listing for short bowel syndrome, final listing 5.07, and a new section in the introductory text, final 5.00F, to provide guidance for evaluating SBS under this listing.
5.00GHow do we evaluate weight loss due to any digestive disorder?

Final 5.00G corresponds to prior 5.00B and proposed 5.00F1 and reflects changes we made to proposed listing 5.08, discussed below. We are simplifying the guidance from prior 5.00B about evaluating malnutrition and weight loss. Under the final rules, it is sufficient for our purposes that the weight loss result from any medically determinable digestive disorder. We are also revising the heading of final 5.00G to refer only to weight loss, instead of the proposed reference to malnutrition and weight loss, to better reflect the content of the section.

We revised proposed listing 5.08 to use Body Mass Index (BMI) to evaluate weight loss instead of using height and weight measurements by gender. BMI is the measurement recommended by the Centers for Disease Control and Prevention (CDC) to determine appropriate weight for height. In final 5.00G1, we explain that we use BMI to evaluate weight loss due to any digestive disorder under listing 5.08 and to evaluate lesser weight loss from IBD under listing 5.06B. The latter is one of the new criteria that we added to the IBD listing in response to public comments.

In final 5.00G2, we explain how we calculate BMI. The change from height and weight measurements to BMI removed the need to provide rules for rounding of height and weight measurements; therefore, we do not include in these final rules the rules for rounding that were in proposed 5.00F1aF1c.
5.00HWhat do we mean by the phrase ``consider under a disability for 1 year''?

Final 5.00H corresponds to proposed 5.00F2f; however, we revised it to make clear that the phrase refers to the date on which we must determine whether an impairment continues to meet a listing or is otherwise disabling, not the date on which disability began. We explain that we do not restrict our finding about the onset date of disability to the date of a specific qualifying event in a listing, such as a liver transplant. For example, many individuals who need liver transplants (final listing 5.09) have impairments that meet one of the criteria for chronic liver disease (final listing 5.05) before they have their liver transplants.

In the proposed rules, we had inadvertently included the explanation of the phrase ``consider under a disability for 1 year'' under the heading for chronic liver disease; however, we also use the phrase in final listing 5.02 for gastrointestinal hemorrhaging from any cause. Therefore, in the final rules, we explain the phrase in a section that is independent of the discussion of chronic liver disease, and we identify the three listings to which it applies.

In proposed 5.00F2f, we had also stated that the phrase was a ``statement about the expected duration of disability.'' In reviewing that language, we realized that it could have been misunderstood to mean that we presume that an individual will no longer be disabled after 1 year. That was not our intent. Rather, we intended to indicate only that after 1 year the impairment would no longer meet the requirements of the particular listing that includes the criterion. The impairment may still be disabling at the end of the period because it may meet or medically equal another listing or result in a residual functional capacity that is consistent with a finding of disability. Also, when we consider whether an impairment continues to be disabling, we apply the medical improvement review standard in Sec. Sec. 404.1594 and 416.994. For these reasons, we are not including the statement in these final rules.
5.00IHow do we evaluate impairments that do not meet one of the digestive disorder listings?

Final 5.00I is generally the same as proposed 5.00E, except that we include hepatitis B or C that results in depression as an example of a digestive impairment we would evaluate in another body system, instead of the hepatic encephalopathy example we included in proposed 5.00E1. This example was no longer appropriate because we have a listing for hepatic encephalopathy (5.05F) in the final rules.
How are we changing the listings for evaluating digestive disorders in adults?
5.01 Category of Impairments, Digestive System

Removal of Redundant or Reference Listings

We are removing four prior listings because they were reference listings and, therefore, were redundant. These four listings were met by referring to the requirements of prior listing 5.08:

All of these impairments are still covered by final listing 5.08. Chronic ulcerative or granulomatous colitis and regional enteritis are also covered by final listing 5.06. We no longer mention them explicitly in these final rules because they have been replaced by the more encompassing term ``inflammatory bowel disease.''

Prior listing 5.05E, hepatic encephalopathy, was also a reference listing, referring to listing 12.02. In the NPRM, we proposed to remove the listing and to add language in proposed sections 5.00E1 and 5.00F2b that reminded adjudicators to evaluate the impairment under the criteria for the appropriate mental disorder or neurological listing. However, in response to many public comments, we decided to remove the proposed guidance and to provide a new listing specifically for hepatic encephalopathy in the digestive listings, final listing 5.05F. Therefore, while we are still removing prior reference listing 5.05E, we are including a different listing for hepatic encephalopathy in these final rules.

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We are also removing the following prior listings because medical knowledge, methods of evaluating digestive disorders, advances in treatment, and our program experience indicate that they are no longer appropriate indicators of listinglevel severity. There has been significant progress in the treatment of these digestive disorders. Many of these disorders can be controlled or resolved and thus are less likely to be of listinglevel severity. Even if listinglevel severity is initially present, the 12month statutory duration requirement will often not be met.

The following is a detailed explanation of the final listings. Listing 5.02Gastrointestinal Hemorrhaging From Any Cause, Requiring Blood Transfusion

We are expanding this listing to include ``gastrointestinal hemorrhage from any cause'' instead of the prior listing's ``upper gastrointestinal hemorrhage from undetermined cause.'' We are also revising the severity criterion in this listing from anemia with a persistent hematocrit level of 30 percent or less, to a requirement for gastrointestinal hemorrhages that require blood transfusions of at least 2 units of blood per transfusion, occurring at least three times, at least 30 days apart, during a consecutive 6month period. A hematocrit level by itself is generally not an appropriate indicator of the severity of gastrointestinal hemorrhage, and as we have already noted, does not necessarily correlate with inability to function.

In these final rules, we are clarifying the proposed rule to explain that an individual does not have to be hospitalized for transfusions under this listing. We did not indicate whether hospitalization was required in the proposed rule. Therefore, this is only an editorial change for clarity.

The proposed listing indicated in a parenthetical statement that ``[a]ll incidents [hemorrhages] within a consecutive 14day period constitute one episode.'' In the final listing, we are revising this statement by removing references to ``incidents'' and ``episodes'' and instead simply using the word ``transfusions,'' since transfusions are the indicators of severity. Also, in response to a public comment, we are increasing the length of time between blood transfusions (described as ``episodes'' in the proposed rule) from 14 days to 30 days. [[Page 59403]]

Since improvements in medical treatment may resolve the frequency of hemorrhages and thus the overall severity of the impairment, we indicate that we will consider an individual to be under a disability for 1 year following the last documented transfusion. After that, we will evaluate the residual impairment(s).

Listing 5.05Chronic Liver Disease

We are replacing prior listing 5.05 with criteria that more accurately reflect listinglevel severity.

Newer techniques in primary prevention and treatment of bleeding gastroesophageal varices, for example, TIPS, banding, sclerotherapy, and laser therapy, have significantly improved the management of bleeding varices. Based on these advances, it is no longer appropriate to presume disability for 3 years as under prior listing 5.05A. Therefore, the final listing (like the proposed listing) provides that we will consider an individual disabled for 1 year following the last documented transfusion. After that, we will evaluate the residual impairment(s).

Final listing 5.05B corresponds to prior listing 5.05D, ascites due to chronic liver disease. In response to comments, we are also including hydrothorax in the listing because ascitic fluid can collect in the chest cavity and result in a very serious impairment. Therefore, we are including thoracentesis in the documentation requirements in final listing 5.05B1 because it provides a definitive diagnosis of hydrothorax, just as paracentesis provides a definitive diagnosis of ascites.

As in the NPRM, we are revising the required time period in which the evaluations showing ascites or hydrothorax must occur from 5 months to 6 months because, in our experience, a 6month period enables us to make a more reliable prediction of duration of an impairment of listinglevel severity. We also are requiring that evaluations be done at least 60 days apart within the 6month period to substantiate the chronic nature of the impairment.

In response to public comments, final listing 5.05B2 now requires documentation of ascites or hydrothorax by physical examination or by appropriate medically acceptable imaging, but not both, as we proposed in the NPRM. However, if the ascites or hydrothorax is documented by physical examination or imaging rather than paracentesis or thoracentesis, we require additional laboratory findings that confirm very serious chronic liver disease. As in proposed listing 5.05B2a, we require serum albumin of 3.0 g/dL or less. In response to public comments, we changed the proposed criterion for a measure of prothrombin time to a criterion for an elevated International Normalized Ratio (INR) of at least 1.5 in final listing 5.05B2b. The public comments correctly indicated that INR is a more widely used study.

We did not agree that all individuals on transplant lists should qualify under our listings because the threshold criteria for placement on a transplant list vary widely throughout the country and some individuals are placed on transplantation lists well before they have listinglevel impairments. In the final rule, we provide that a SSA CLD score of 22 or greater meets the listing. We chose this score based on the clinical severity represented by the laboratory values contained in the SSA CLD score.

For final listing 5.05G, we require two calculations of SSA CLD scores, at least 60 days apart, and that the scores must be calculated within a consecutive 6month period, consistent with other provisions in these final rules.

Listing 5.06Inflammatory Bowel Disease

We are combining portions of prior listings 5.06 and 5.07 into final listing 5.06. Ulcerative colitis, Crohn's disease, granulomatous colitis, and regional enteritis are now commonly referred to as ``inflammatory bowel disease'' (IBD).

In the NPRM, proposed listing 5.06 required documentation of IBD with persistent or recurrent intestinal obstruction. The proposed listing repeated the criteria from prior listing 5.07A, clarified that the intestinal obstruction must be documented by appropriate medically acceptable imaging or operative findings, and
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included the requirement for documentation of two episodes of obstruction over a consecutive 6month period despite prescribed treatment, to ensure that there is a chronic impairment.

In response to public comments, we are significantly revising and expanding final listing 5.06. As in the proposed listing, the introductory paragraph of final listing 5.06 requires documentation of IBD by endoscopy, biopsy, appropriate medically acceptable imaging, or operative findings. As in the NPRM, final listing 5.06A requires obstruction of stenotic areas in the small intestine or colon with proximal dilatation. We are clarifying in the final rule that adhesions do not satisfy the requirement for obstruction. This is not a substantive change but a clearer statement of our intent that there must be obstruction that results from IBD. We are also clarifying that, in these cases, the stenotic areas may be shown by surgery or by medically acceptable imaging. In addition, we are clarifying the language we had proposed by requiring hospitalization for treatment of the obstruction (intestinal decompression or surgery). This is not a substantive change from the NPRM because listinglevel obstruction of a stenotic area would require hospitalization for one of these types of treatment. Therefore, the requirement in the final listing will only help to confirm the existence of listinglevel obstruction caused by IBD.

We are deleting the proposed requirement for persistent or recurrent obstruction over a consecutive 6month period despite prescribed treatment in response to a public comment. Instead, we are requiring that the findings occur on at least two distinct occasions at least 60 days apart within a consecutive 6month period.

Final listing 5.06B includes six other manifestations of IBD that were suggested by commenters. Consistent with most of the other criteria in the final rules for impairments that have episodic manifestations, final listing 5.06B requires that two of the six criteria be present on at least two evaluations, occurring at least 60 days apart within the same consecutive 6month period, except for listing 5.06B6, which requires supplemental daily enteral nutrition via a gastrostomy or daily parenteral nutrition via a central venous catheter.

Listing 5.07Short Bowel Syndrome

As we explained earlier, we are removing prior listing 5.07, for regional enteritis. Instead, we evaluate this condition under final listing 5.06, for IBD. However, in response to comments regarding individuals who need parenteral nutrition, we are adding a new listing, final listing 5.07, for short bowel syndrome to address situations in which postoperative nutritional needs cannot be met orally or with supplemental enteral nutrition. This final listing requires a diagnosis of short bowel syndrome due to surgical resection of more than onehalf of the small intestine with resulting dependence on daily parenteral nutrition via a central venous catheter.

Listing 5.08Weight Loss Due to Any Digestive Disorder

In this final rule, we changed the heading of prior and proposed listing 5.08, ``Weight loss due to any persisting gastrointestinal disorder'' to ``Weight loss due to any digestive disorder.'' We deleted the word ``persisting'' for reasons we explain in the public comments section of this preamble.

In final listing 5.08, we are establishing the severity of the weight loss based on the CDC's BMI formula, rather than the Metropolitan Life Insurance Company's weight charts we used in the proposed rules and which were last updated in 1983. When we published the NPRM in 2001, we indicated that neither the CDC nor any other recognized authority known to us had determined a BMI for adults that would be consistent with listinglevel severity weight loss. However, since that time, we determined that we could establish a BMI comparable to the severity standard in the weight charts. We established this BMI level in the final listing by calculating the BMI for each value on proposed weight tables I and II and averaging them.

We are changing to the more widely used BMI for several other reasons. For example, this change eliminates the need for gender tables, as BMI is not genderspecific in adults. Also, we were not able to apply the prior and proposed weight tables to individuals whose height was outside the table values, and instead had to review the evidence and determine whether the impairment medically equaled the listing. Now we can apply the BMI formula to all cases regardless of the individual's height. Also, our use of BMI in this body system is consistent with our use of BMI in Social Security Ruling 021p, Title II and XVI: Evaluation of Obesity (67 FR 57859).

Listing 5.09Liver Transplantation

In the NPRM, we proposed to add listing 5.09 for liver transplantation. However, we published final rules adding this listing on April 24, 2002 (67 FR 20018) based on another NPRM in which we had also proposed to add this listing. (See 65 FR 6934.) Therefore, in these final rules, we are retaining the listing we published in April 2002, revising it to include the phrase ``1 year following the date of transplantation,'' and changing the punctuation to make it easier to read. The only public comments we received about this listing agreed that we should add it.
How are we changing the introductory text to the listings for evaluating digestive disorders in children?

105.00 Digestive System

As in the adult rules, we are revising the introductory text to the digestive system in part B, final 105.00, to provide additional guidance for adjudicating digestive disorders. Where necessary, we are adding information specific to children; however, we are repeating much of the introductory text of final 5.00 in final 105.00. This is because, for the most part, the same basic rules for establishing and evaluating the existence and severity of digestive disorders in adults also apply to children. We are making a number of changes from the NPRM in the final rules to make part B even more consistent with part A than we originally proposed. As we note below, we are also adding:

The following discussions describe only the significant provisions that are unique to the childhood rules or that require further explanation. We do not note differences like the fact that we use references to childhood listings instead of adult listings or that we use references to ``children'' instead of adults.
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105.00AWhat kinds of disorders do we consider in the digestive system?

Final 105.00A corresponds to final 5.00A, except that we are adding information to explain that under the childhood listings we also consider congenital abnormalities involving the organs of the gastrointestinal system.

105.00BWhat documentation do we need?

The only substantive difference between final 105.00B and final 5.00B is a statement noting that we may also need assessments of a child's growth and development.

105.00DHow do we evaluate chronic liver disease?

The new guidance on chronic liver disease in final 105.00D generally corresponds to the information in final 5.00D in the adult rules, except for information specific to the complications of chronic liver disease in children and two sections (final 105.00D11b and 105.00D12) that are not in part A because they provide guidance for listing criteria that are only in the final childhood rules.

In final 105.00D11b, we provide information about the SSA Chronic Liver DiseasePediatric (SSA CLDP) calculation, which we use under final listing 105.05G2 for children who have not attained age 12. We explain in final 105.00D11b(iv) that we will not purchase the INR value required to calculate the SSA CLDP score because obtaining the necessary amount of blood to perform this test in small children often requires an invasive procedure. We further explain that if we do not have an INR value for a child under 12 within the applicable time period, we will use an INR value of 1.1 for the SSA CLDP calculation. (In final 105.00D11a, we provide the same guidelines about the SSA CLD calculation as we do in part A because the SSA CLD calculation is applicable to children age 12 to the attainment of age 18.)

In final 105.00D12, we provide guidance for applying final listing 105.05H for extrahepatic biliary atresia, a congenital disorder of the liver.
105.00EHow do we evaluate inflammatory bowel disease (IBD)?

Final 105.00E corresponds to final 5.00E. In the NPRM, we proposed a short section (proposed 105.00F4) on IBD that provided guidance for evaluating IBD under proposed listing 105.06. As in final listing 5.06 in part A, we have greatly expanded proposed listing 105.06 in these final rules, so we are also including the more detailed guidance for evaluating the expanded listing criteria of final listing 105.06 that we provide in part A for final listing 5.06.

105.00GHow do we evaluate malnutrition in children?

Final 105.00G (proposed 105.00F1) reflects changes we made to final listing 105.08, Malnutrition due to any digestive disorder. In final 105.00G1, we explain that digestive disorders may result in malnutrition and growth retardation. We also explain that we document the presence of a digestive disorder with associated chronic nutritional deficiency despite prescribed treatment using the malnutrition criteria in final listing 105.08A.

The malnutrition criteria in final listing 105.08A generally correspond to the laboratory findings we presented as examples in the introductory text, proposed 105.00F1(a)(1), F1(a)(2), and F1(a)(4). We are including them as listing criteria in final listing 105.08A in response to a public comment.

Final listing 105.08A1 corresponds to proposed 105.00F1(a)(1). However, we changed the criterion for anemia to a hemoglobin of less than 10.0 g/dL, rather than less than 8 g/dL, to be consistent with the anemia criteria elsewhere in these final listings. Final listing 105.08A2 requires low serum albumin levels and corresponds to proposed 105.00F1(a)(2). Final listing 105.08A3 corresponds to proposed 105.00F1(a)(4), except that we added the phrase ``fat soluble'' to clarify the type of vitamin deficiency we intended. We also removed the concluding phrase ``despite aggressive medical and nutritional therapy'' because the introductory paragraph of the listing requires findings ``despite continuing treatment as prescribed.'' We did not include as a listing criterion the example of intractable steatorrhea (malabsorption of dietary fats) quantified by fecal fat excretion that we had included in proposed 105.00F1(a)(3); most pediatric laboratories no longer do this type of testing, and steatorrhea will usually result in the vitamin deficiency we describe in final listing 105.08A3.

In 105.00F1b of the proposed rules, we included a paragraph discussing Body Mass Index (BMI) measurements. We explained in the preamble of the NPRM that we proposed to add this discussion because proposed listing 105.08 included criteria based on BMI measurements. (See 66 FR at 57015 and 57020.)

We are not including this paragraph in the final rules because, when we reviewed it, we realized that it did not provide guidance that would have been useful to the application of final listing 105.08 and that it could have been confusing for the following reasons:

In final 105.00G2, which replaces proposed 105.00F1b, we are providing information that is more relevant to the application of final listing 105.08B. We explain that we use the most recent growth charts published by the CDC. In final 105.00G2a, we explain that we use the CDC's age and genderspecific weightforlength charts for children who have not attained age 2. In final 105.00G2b, we explain that we use the CDC's genderspecific BMIforage charts for children age 2 or older. In final 105.00G2c, we explain how we calculate BMI, and in final 105.00G2d we provide the corresponding BMI formulas. Final 105.00G2c and 105.00G2d are the same as final 5.00G2a and 5.00G2b. 105.00HHow do we evaluate the need for supplemental daily enteral feedings via a gastrostomy?

Final 105.00H is a new section that provides guidance for evaluating the need for feeding gastrostomies for children under age 3 under final listing 105.10. We had previously provided for a finding of functional equivalence for children under age 3 who require a gastrostomy for feeding in Sec. 416.926a(m)(10). We are now making that example of functional equivalence a listing and removing the example from Sec. 416.926a(m).
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105.00IHow do we evaluate esophageal stricture or stenosis?

Final 105.00I corresponds to proposed 105.00F3 and includes minor editorial changes for clarity. In this section, we provide guidance for evaluating esophageal stricture or stenosis, which we had listed in prior listing 105.03, a listing we are removing because it is a reference listing. In the final rule, we explain that these conditions may be evaluated under listing 105.08 or 105.10. We also provide guidance for adjudicating these conditions when they do not meet a listing but the child still has problems maintaining nutritional status.
105.00KHow do we evaluate impairments that do not meet one of the digestive disorder listings?

Final 105.00K corresponds to final 5.00I, except that we include two additional examples of digestive impairments relevant to children that we would evaluate in other body systems. These are the same additional examples we included in proposed 105.00E1; however, we made minor editorial changes to these examples for clarity.
How are we changing the listings for evaluating digestive disorders in children?
105.01 Category of Impairments, Digestive System

Removal of Redundant or Reference Listings

As in the adult listings, we are removing the following reference listings and other listings that are no longer appropriate:

Prior listing 105.05E, for hepatic encephalopathy, was a reference listing, referring to listing 112.02 for organic mental disorders. For the reasons we cited in our discussion of prior listing 5.05E (final listing 5.05F) above, we are including criteria for evaluating hepatic encephalopathy in the digestive listings, final listing 105.05F, instead of evaluating this impairment under the criteria for organic mental disorders. We will also evaluate the impairment in prior listing 105.05D, hepatic coma, under final listing 105.05F.

The following is a detailed explanation of the changed listing criteria where they differ from the part A listings.
Listing 105.02Gastrointestinal Hemorrhaging From Any Cause, Requiring Blood Transfusion

Final listing 105.02, which corresponds to final listing 5.02, was not in the NPRM. We are adding it in response to a public comment described later in this preamble. The final listing is the same as final listing 5.02, except for the amount of blood transfused. In final listing 105.02, we provide a ratio of volume of blood to the child's weight, which is a more medically appropriate standard for children. Listing 105.05Chronic Liver Disease

Final listing 105.05A replaces prior listing 105.05C, chronic liver disease with esophageal varices. The final listing is the same as final listing 5.05A, except for the amount of blood transfused. As in final listing 105.02, we provide a ratio of volume of blood to the child's weight, which is a more medically appropriate standard for children.

Final listings 105.05C, D, E, F, and G correspond to final listings 5.05C, D, E, F, and G in part A, with appropriate changes to reflect findings and laboratory values for children. Also, final listing 105.05G includes both an SSA CLD score criterion for children age 12 and older (final listing 105.05G1) and an SSA CLDP score criterion for children who have not attained age 12 (final listing 105.05G2).

We provide that an SSA CLDP score of 11 or greater meets the listing. We chose this score based on the clinical severity represented by the values contained in the SSA CLDP score, which we believe represents the degree of severity consistent with listing level severity.

For final listing 105.05G2, we require two calculations of SSA CLD P scores, at least 60 days apart, and the scores must be calculated within a consecutive 6month period, consistent with other provisions in these final rules.

Final listing 105.05H replaces prior listing 105.05A, inoperable biliary atresia. The new listing requires extrahepatic biliary atresia, as diagnosed on liver biopsy or intraoperative cholangiogram. We will consider children who meet this requirement to be disabled for 1 year following the diagnosis, and we will evaluate residual liver function after that period.

Listing 105.06Inflammatory Bowel Disease (IBD)

We are redesignating prior listing 105.07, chronic inflammatory bowel disease, as final listing 105.06 for consistency with the corresponding adult listing. Final listing 105.06 is the same as final listing 5.06, except that it does not include a criterion for weight loss from baseline. This criterion is inappropriate for children because they are continually growing, and therefore do not have a ``baseline weight.'' (We can evaluate weight loss, inadequate growth, and malnutrition secondary to IBD under final listing 105.08.)

Proposed listing 105.06B required IBD with perineal or intra abdominal complications, such as abscess, fistulae, or fecal incontinence. These complications must have been intractable despite medical or surgical treatment, and clinically documented over a 6month period. Final listing 105.06 includes a criterion for perineal disease with draining abscess or fistula. However, we did not include fecal incontinence because final listing 105.06 includes a much wider array of complications resulting from IBD and children with listinglevel impairments who have fecal incontinence would be evaluated under criteria in final listing 105.06.

Listing 105.07Short Bowel Syndrome (SBS)

This new listing is the same as final listing 5.07 except that it applies to children. It eliminates the need for a finding of functional equivalence for children of any age who have a frequent need for a central venous alimentation catheter, as we described in the example of functional equivalence in prior Sec. 416.926a(m)(3).

Listing 105.08Malnutrition Due to Any Digestive Disorder

Final listing 105.08 corresponds to proposed listing 105.08; however, as we have already noted, we are including as listing criteria three of the examples of laboratory findings that would confirm chronic nutritional deficiency we had included in proposed 105.00F1a. We also removed the statement from proposed listings 105.08A and B that the required findings are ``expected to persist for at least 12 months,'' because it is unnecessary. Under our general
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rules for evaluating disability, an impairment must meet the duration requirement.

Final listing 105.08 is consistent with the weightforlength and BMIforage charts and data file tables from the CDC. According to the CDC, these are the recommended measurements to determine if an individual's weight is appropriate for his or her height. On May 30, 2000, the CDC updated its 1977 weightforlength growth charts, and introduced BMIforage charts and tables.\1\ The CDC explained that: \1\Centers for Disease Control and Prevention, National Center for Health Statistics. CDC growth charts: United States. May 30, 2000.

These BMIforage charts were created for use in place of the 1977 weightforstature charts. BMI * * * is used to judge whether an individual's weight is appropriate for their height. * * * The new BMI growth char

FOR FURTHER INFORMATION CONTACT

James Julian, Director, Office of Medical Policy, Social Security Administration, 4470 Annex Building, 6401 Security Boulevard, Baltimore, Maryland 212356401, 4109654015. For information on eligibility or filing for benefits, call our national tollfree number 18007721213 or TTY 18003250778, or visit our Internet Web site, Social Security Online, at http://www.socialsecurity.gov .