Under title XVI of the Act, we provide for SSI payments on the basis of disability to adults and children who have limited income and resources.

How Do We Define Disability?

Under both the title II and title XVI programs, disability must be the result of any medically determinable physical or mental impairment or combination of impairments that can be expected to result in death or that has lasted or can be expected to last for a continuous period of at least 12 months. Our definition of disability is shown in the following table:
Disability means you have a medically determinable If you file a claim under * And you are * * * impairment(s) that * * meets the statutory duration requirement and results in * * * title II.................... an adult or a child. the inability to do any substantial gainful activity (SGA)
title XVI................... an adult............ the inability to do any SGA title XVI................... a child............. marked and severe functional limitations What Are the Listings?

The listings contain examples of impairments that we consider severe enough to prevent an adult from doing any gainful activity, or that cause marked and severe functional limitations in a child. Although the listings are contained only in appendix 1 to subpart P of part 404, we incorporate them by reference in the SSI program by Sec. 416.925 of our regulations.

How Do We Use the Listings?

We divide the listings into part A and part B. We apply the medical criteria in part A when we assess the claims of adults. We may also use the medical criteria in part A when we evaluate the claims of children, if the disease processes have a similar effect on adults and children. However, we first use the criteria in part B to evaluate claims by children. If the criteria in part B do not apply, we then use the criteria in part A. (See Secs. 404.1525, 404.1526, 416.925 and 416.926.)

We use the criteria in the listings only to make favorable determinations or decisions regarding disability. We never deny a claim or find that an individual's disability has ceased because an impairment(s) does not meet or medically equal a listing. When an individual has a severe impairment(s) that does not meet or medically equal a listing, we may still find him or her disabled (or still disabled) based on other rules. For more information about our sequential evaluation processes for adults and children, see Secs. 404.1520, 416.920, and 416.924 of our regulations regarding initial claims, and Secs. 404.1594, 416.994, and 416.994a of our regulations regarding continuing disability reviews.
Why Are We Proposing To Revise the Listings for Hematological Disorders and Malignant Neoplastic Diseases?

We last published final rules revising the listings for the hemic and lymphatic system and the malignant neoplastic diseases system in the Federal Register on December 6, 1985 (50 FR 50068). In the preamble to those rules, we indicated that due to medical advances in disability evaluation and treatment and program experience we would periodically review and update the listings. The current listings for the [[Page 59307]]
hemic and lymphatic system and malignant neoplastic diseases will no longer be effective on July 2, 2003. We are proposing to update the listings in part A, 7.00 and 13.00, and in part B, 107.00 and 113.00. We propose to make the rules effective for 5 years from their effective date, unless we extend them, or revise and issue them again.

We will continue to apply our current listings until we evaluate the public comments on these proposed rules and determine whether they should be issued as final rules. If we finalize these proposed rules, when any final rules become effective, we will apply them to new applications filed on or after the effective date of the final rules, and to cases that are pending in the administrative review process. In accordance with our usual practice, we would explain how we would apply any final rules in greater detail in the preamble to the final rules.

When we conduct reviews to determine whether your disability continues, we would not find that your disability has ended based only on any changes in the listings. Our regulations explain that we continue to use our prior listings when we review your case if you receive disability benefits or SSI payments based on our determination or decision that your impairment(s) met or equaled the listings. In these cases, we determine whether you have experienced medical improvement, and if so, whether the medical improvement is related to the ability to work. If your impairment(s) still meets or equals the same listing section that we used to make our most recent favorable determination or decision, we will find the medical improvement is not related to the ability to work. If your condition has medically improved so that you no longer meet or equal the prior listing, we evaluate your case further to determine whether you are currently disabled. We may find that you are currently disabled, depending on the full circumstances of your case. See 20 CFR 404.1594(c)(3)(i), 416.994(b)(2)(iv)(A). If you are a child who is eligible for SSI payments, we follow a similar rule when we decide whether you have experienced medical improvement in your condition. 20 CFR
416.994a(b)(2).
What Revisions Are We Proposing That Affect Both the Hematological Disorders and Malignant Neoplastic Diseases Listings?

To present the listing criteria in a more logical order, and make the listings easier to use, we propose to:

We also propose to use the phrase ``bone marrow or stem cell transplantation'' in proposed listings 7.06, 107.06, 13.28, and 113.28 instead of ``bone marrow transplantation'' as used in current listing 7.17. The purpose of bone marrow transplantation is to transplant stem cells, but stem cells from other sources, such as peripheral blood or cord blood, may also be used. Because of this, the phrase ``stem cell transplantation'' more accurately represents the type of
transplantation addressed in the proposed listings. However, as ``bone marrow transplantation'' is still in common usage, we would also retain it in our listings in order to avoid confusion.

In several of the proposed listings, such as listings 7.03A2, 13.28, and 113.11D, we provide that we will consider the individual disabled for a specified period of time, such as for 12 months from the date of diagnosis. After that time, we will evaluate any residual impairment(s) under the criteria for the affected body system. In these situations, the beginning date specified is not related to the onset date; it is used only to calculate the period of time we would presume the impairment is disabling. We can establish an earlier onset date if the individual is not engaging in SGA and the evidence in file supports the earlier onset date.

We also propose to make nonsubstantive editorial changes to update the medical terminology in the listings and to make the language clearer.
How Are We Proposing To Change the Preface to the Listings for Evaluating Hematological Disorders in Adults?

7.00 Hematological Disorders

We propose to change the name of this body system from Hemic and Lymphatic System to Hematological Disorders because we are proposing to move the lymphatic impairments now contained in 7.00 to 13.00, Malignant Neoplastic Diseases.

Because we are proposing to move the criteria for evaluating leukemia to proposed listing 13.06, we propose to move the guidance contained in current 7.00E, ``Acute leukemia,'' to proposed 13.00K(2)(a). We discuss our revisions to that guidance in the explanation of proposed 13.00K(2)(a).

We also propose to expand and reorganize the introductory material in 7.00 to provide additional guidance and reflect the new listings. The following is a detailed explanation of the proposed material. Proposed 7.00AWhat Do We Consider When We Evaluate Hematological Disorders Under These Listings?

In this new section, we list the factors we consider. Proposed 7.00BWhat Documentation Do We Need?

To clarify the first sentence of current 7.00B, ``Chronicity,'' we explain that we
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generally need a longitudinal clinical record covering a period of at least 3 months of observations and treatment unless we can make a fully favorable determination or decision without it.

We expand the second sentence of current 7.00B to provide examples of the types of laboratory findings that should be in the longitudinal clinical record.

We also clarify, in 7.00B(2) and 7.00B(3), what additional information the longitudinal clinical record should contain. Proposed 7.00CHow Do We Evaluate Impairments That Do Not Meet One of the Hematological Disorders Listings?

In this new section, we state our basic adjudicative principle that if the individual's impairment(s) does not meet or medically equal the requirements of a listing, we will continue the sequential evaluation process to determine whether or not the individual is disabled. Proposed 7.00DHow Do We Assess the Effectiveness of Treatment?

In this new section, we set forth our policy on considering the response to, effectiveness of, and adverse consequences of treatment. Proposed 7.00EHow Do We Evaluate Episodic Hematological Disorders?

In this new section, we propose to revise the requirement in our current listings that events for episodic hematological impairments occur within the 5month or 12month period prior to adjudication. Instead of using the date of adjudication, as we do under the current criteria, we propose to require that the events occur within the period we consider in connection with the application or continuing disability review; that is, the period for which we will develop medical evidence through the date we make our determination or decision. Sections 404.1512(d)(2), 404.1593(b), 416.912(d)(2), and 416.993(b) of our regulations discuss the period for which we will develop medical evidence. This period generally begins 12 months prior to either the date of the application or the date the individual signed a report about his or her continuing disability status. This proposed approach is consistent with the way we evaluate episodic impairments in other body systems.

We also indicate that in every listing in which we require more than one event, there must be at least 1 month between the events. We propose this requirement to ensure that we are evaluating separate episodes.

Proposed 7.00FWhat Do These Terms in the Listings Mean?

We propose to define the terms ``persistent'' and ``repeated'' or ``repeatedly'' in the hematological disorders listings.
Proposed 7.00GHow Do We Evaluate Specific Hematological Disorders?

We propose to incorporate and clarify current 7.00A, ``Impairment caused by anemia,'' 7.00C, ``Sickle cell disease,'' and 7.00D, ``Coagulation defects,'' and add guidance for evaluating additional hematological disorders. The following is a discussion of the information provided for the disorders in this section.

Proposed 7.00G(1)Anemia

This paragraph corresponds to current 7.00A, ``Impairment caused by anemia'' and would also replace current listing 7.02B. Current listing 7.02B provides that the effects of chronic anemia should be evaluated under the criteria for the affected body system. In addition to causing residual impairments, chronic anemia can be a marker of severity for an underlying disorder, such as myelofibrosis. Thus, we propose to expand our guidance on chronic anemia to provide that this impairment can be evaluated under the criteria for the underlying disorder or for the affected body system.
Proposed 7.00G(2)Sickle Cell Disease or One of Its Variants

This paragraph corresponds to the first two paragraphs of current 7.00C. We propose to clarify the policy regarding hematological evidence by adding that, in lieu of a copy of the actual laboratory report, we will accept medical evidence that is persuasive that a positive diagnosis has been confirmed by appropriate laboratory testing at some time prior to evaluation.

We propose to delete the third paragraph of current 7.00C, which defines ``major visceral episodes,'' because the term does not appear in the listings. The term ``major visceral complication'' does appear in the current childhood listing for sickle cell disease, listing 107.05B. Instead of extending the criterion to adults, we propose to delete it from the childhood listing. We explain our reasons for doing so in the discussion of proposed listing 107.02A (the proposed listing that corresponds to current listing 107.05).

Proposed 7.00G(3)Disorders of Hemostasis

This section corresponds to current 7.00D ``Coagulation defects.'' We are using a more comprehensive term to reflect the criteria in proposed listing 7.03, ``Disorders of hemostasis.'' We would continue to include coagulation defects in the revised section, but as an example rather than as the only disorder covered by the listing.

We would also revise our guidance on how to document these disorders to address all the disorders covered by the proposed listing and to update the medical terminology. We are also adding guidance on how to consider complications of these disorders.

Proposed 7.00G(4)Hematological Malignancies

The current criteria for evaluating hematological malignancies, such as lymphoma, leukemia, macroglobulinemia or heavy chain disease, and myeloma, are in 7.00. As we indicated above, we propose to move these disorders to 13.00, Malignant Neoplastic Diseases. We are adding this section to reflect that move. We are also adding a reminder that there is a separate listing for lymphoma associated with HIV infection, listing 14.08E.

Proposed 7.00G(5)Chronic Iron Overload

The medical community is increasingly recognizing complications from this disorder. We propose to add this section to provide guidance on evaluating these complications under the listings.
Proposed 7.00HHow Do We Evaluate nonmalignant Hematological Disorders Treated by Allogeneic Bone Marrow or Stem Cell

Transplantation?

We provide that nonmalignant hematological disorders treated by allogeneic bone marrow or stem cell transplantation must be evaluated under the criteria in proposed listing 7.06, regardless of whether there is another listing that addresses that impairment. We discuss the criteria in proposed listing 7.06. We also discuss some of the factors we consider when we evaluate any residual impairment(s) that results from transplantation.
How Are We Proposing to Change the Criteria in the Listings for Evaluating Hematological Disorders in Adults?
7.01 Category of Impairments, Hematological Disorders

In addition to proposing to move listings 7.11, 7.12, 7.13, 7.14, and 7.16, we propose to delete current listings 7.02, ``Chronic anemia (hematocrit persisting at 30 percent or less due to any cause),'' and 7.07, ``Hereditary telangiectasia.''

[[Page 59309]]

Current listing 7.02A requires one or more blood transfusions on an average of at least once every 2 months. The average frequency of blood transfusions is not an accurate measure of severity or duration of the impairment. If an individual had several transfusions performed close together in the past and none thereafter, the average might still satisfy the frequency criterion for the current listing, even though the underlying impairment may not have persisted at this level. Also, some individuals with anemia may be treated with scheduled red cell transfusions in order to maintain the oxygencarrying capacity of the blood.

As we explained above, we propose to retain the criterion in current listing 7.02B, evaluation of the resulting impairment under the criteria for the affected body system, in proposed 7.00C.

We propose to delete current listing 7.07 because listinglevel hereditary telangiectasia is rare and can be evaluated under other criteria, for example, those for other hematological disorders or for the affected body system, such as digestive.

The provisions of proposed 7.00E apply to proposed listings 7.02A, 7.02B, 7.03A2, 7.03B, 7.03C, 7.04B, and 7.05. Because we have already discussed the provisions in proposed 7.00E, they are not included in the following explanation of the proposed listing criteria. Proposed Listing 7.02Sickle Cell Disease or One of its Variants

This proposed listing has three separate evaluation criteria. Proposed listing 7.02A, documented painful (vasoocclusive) crises, corresponds to current listing 7.05A. We propose to include a requirement that the crises require parenteral medication, to clarify the level of severity intended by the listing.

We also propose to lengthen the period of time during which the pain crises must occur from 5 months to 6 months. We believe that pain crises of the type described in proposed listing 7.02A that occur at least 3 times in a 6month period are indicative of listinglevel severity.

Proposed listing 7.02B, hospitalization (for 24 hours or more), is similar to current listing 7.05B. We propose to replace the current requirement of ``beyond emergency care'' with ``for 24 hours or more'' to more clearly define our intent.

Proposed listing 7.02C, chronic anemia, corresponds to current listing 7.05C. We propose to revise the criterion to provide a more accurate measure of severity. The current criterion is a persistent hematocrit of 26 percent or less. A hematocrit at this level does not necessarily correlate to an inability to perform any gainful activity. The hemoglobin level required in the proposed listing is indicative of an impairment that we believe would preclude any gainful activity in individuals with sickle cell disease. Throughout these proposed listings, we are using hemoglobin levels instead of hematocrit values as used in the current listings. Hemoglobin levels are measured directly; hematocrit values must be derived.

We also propose to delete the word ``severe,'' which is used in current listing 7.05C. The use of the word ``severe'' in current listing 7.05C is not intended to be the same as the definition of ``severe'' in Secs. 404.1521 and 416.921 of our regulations. We believe the proposed revision is sufficiently clear that we do not need the word. Therefore, we propose to delete it to avoid confusion.

As part of our effort to eliminate reference listings, we propose to delete the criterion in current listing 7.05D, which provides for evaluation of the resulting impairment under the criteria for the affected body system. We have incorporated this criterion in proposed 7.00C(1).

Proposed Listing 7.03Disorders of Hemostasis

As already noted, we propose to incorporate current listings 7.06, ``Chronic thrombocytopenia,'' and 7.08, ``Coagulation defects,'' under this heading and provide criteria for evaluating hypercoagulable states. The following is a discussion of the criteria in the proposed listing.
Proposed Listing 7.03AChronic Thrombocytopenia (Due to Any Cause)

This listing corresponds to current listing 7.06. We propose the following changes:

Proposed Listing 7.03BHemophilia

This listing and proposed listing 7.03C correspond to current listing 7.08, ``Coagulation defects (hemophilia or a similar disorder).'' We propose to separate hemophilia from other
hypocoagulable disorders because, unlike those other disorders, current treatment for most individuals with hemophilia includes the use of prophylactic factor replacement. Consistent with this treatment, we propose to replace the requirement for transfusions with a criterion indicating that the bleeding occurs despite prophylactic factor replacement. We would also revise the frequency of bleeding episodes to be consistent with the changes in proposed listing 7.03A2.
Proposed Listing 7.03COther Hypocoagulable States (Such as von Willebrand's Disease, or Thrombasthenia)

In this listing, we propose criteria for evaluating hypocoagulable states other than hemophilia. We would change the
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frequency of bleeding episodes to be consistent with other proposed listings. We would require hospitalization instead of transfusions to recognize that bleeding in these disorders may often be managed with other forms of treatment. Hospitalization is usually required when the bleeding cannot be easily controlled.
Proposed Listing 7.03DHypercoagulable States (Deficiency of Anti coagulant Proteins Such as C, Protein S, And Antithrombin, or the Presence of Abnormal Proteins Such as Factor V Leiden)

We propose to add this listing to recognize that, for individuals with this disorder, thrombotic episodes are comparable to bleeding episodes in individuals who are hypocoagulable.
Proposed Listing 7.04Aplastic Anemia, Myeloproliferative Disorders (Such as Polycythemia Vera or Myelofibrosis), or Myelodysplastic Syndrome

We propose to combine these disorders because, despite differing etiologies, the functional consequences are similar. This proposed listing incorporates current listings 7.09, ``Polycythemia vera,'' and 7.10, ``Myelofibrosis.''

In proposed listing 7.04A, we would revise the anemia criterion in current listing 7.10A and extend it to the other disorders in the listing. Current listing 7.10A contains a crossreference to current listing 7.02A which, for the reasons explained above, we are proposing to delete. The proposed anemia criterion is ``repeated hemoglobin of 7.0 gm/dl or less despite prescribed therapy.''

In proposed listing 7.04B, we would revise the infection criterion in current listing 7.10B and extend it to the other disorders in this listing. We propose to require documentation of treatment with parenteral antimicrobial medication, the treatment given for systemic infections, to more clearly define a systemic infection. By using this type of treatment, which is also used to treat other types of systemic infections, such as viral or fungal infections, we are broadening the criterion to acknowledge that other types of systemic infections have the same impact as bacterial infections. We would also revise the frequency of treatment requirement to be consistent with other proposed listings.

As part of our efforts to eliminate reference listings, we propose to delete the criterion in current listing 7.09 that provides for the evaluation of the resulting impairment under the criteria for the affected body system. Instead, we provide general guidance to this effect in 7.00C(1). We also propose to delete the criterion in current listing 7.10C of intractable bone pain with radiologic evidence of osteosclerosis. This complication is very rare, and can be evaluated under the listings 1.00 ff., Musculoskeletal System.
Proposed Listing 7.05Chronic Granulocytopenia (Due to Any Cause)

This listing corresponds to current listing 7.15. We propose three revisions to the criteria:

We propose to revise the rule in current listing 7.17, ``Aplastic anemias or hematological malignancies (excluding acute leukemia),'' to recognize the increasing number of diseases treated by allogeneic bone marrow or stem cell transplantation. While the current rule does not specify allogeneic transplantation, it is the type of transplantation that is performed for the disorders evaluated under this body system. We are identifying the type of transplantation in the proposed rule for clarity.

Under this proposed listing, we would consider an individual disabled until at least 12 months from the date of transplantation. As with other proposed listings that use the phrase ``at least,'' there is leeway to establish a longer period when it is justified by the medical evidence. The proposed rule acknowledges the early uncertainty of the outcome, but recognizes that 12 months after the transplant an individual may have improved significantly.
How Are We Proposing to Change the Preface in the Listings for Evaluating Malignant Neoplastic Diseases in Adults?

13.00 Malignant Neoplastic Diseases

We propose to expand and reorganize the preface to these listings to provide additional guidance and reflect the new listings. The following is a detailed explanation of this proposed material. Proposed 13.00AWhat Impairments Do These Listings Cover?

In this new section, we explain that we use these listings to evaluate all malignant neoplasms except carcinoma of the cervix, Kaposi's sarcoma, lymphoma, and squamous cell carcinoma of the anus in individuals with HIV infection. We would continue to evaluate these impairments under listing 14.08E.
Proposed 13.00BWhat Do We Consider When We Evaluate Malignant Neoplastic Diseases Under These Listings?

This section corresponds to current 13.00A, ``Introduction.'' For clarity, we propose to use ``origin of the malignancy'' instead of the current prefatory language, ``the site of the lesion, the histogenesis of the tumor.'' We also propose to change the phrase ``apparent adequacy and response to therapy'' in the current section to ``[r]esponse to antineoplastic therapy'' to eliminate any
misunderstanding concerning who can make judgments about the appropriateness of the treatment regimen. ``Apparent adequacy'' was intended to mean effectiveness of the therapy. Judgments about its appropriateness must be left entirely to the claimant's treating source. We are adding the word ``antineoplastic'' to be consistent with the language in the listing criteria. We also are specifically identifying the types of antineoplastic therapy referred to in the listings.

Proposed 13.00CHow Do We Apply The Listings?

In this new section, we explain that, except for metastatic carcinoma to the brain or spinal cord (proposed listing 13.13C), we apply the listing criteria to a malignant neoplastic disease originating from the site addressed by the particular listing. Proposed 13.00DWhat Evidence Do We Need?

We propose to expand the guidance in current 13.00B, ``Documentation,'' by:

Proposed 13.00EWhen Do We Need Longitudinal Evidence?

We propose to incorporate and expand the guidance in the fourth paragraph of current 13.00C, ``Evaluation.'' We explain when we need longitudinal evidence, and the time period such evidence should cover. We also explain when we may need to defer adjudication.
Proposed 13.00FHow Do We Evaluate Impairments That do not Meet One of the Malignant Neoplastic Diseases Listings?

This paragraph corresponds to the first sentence in the second paragraph of current 13.00D, ``Effects of Therapy.'' We state our basic adjudicative principle that if the individual's impairment(s) does not meet or medically equal the requirements of a listing, we will continue the sequential evaluation process to determine whether or not the individual is disabled.

Proposed 13.00GHow Do We Consider the Effects of Therapy?

We propose to reorganize the guidance in current 13.00D, ``Effects of Therapy.'' We also propose to clarify that we will not delay adjudication to determine whether the therapy has achieved its intended effect if we can make a fully favorable determination or decision based on the evidence in the case record.
Proposed 13.00HHow Long Do We Consider the Individual Disabled?

We propose to incorporate and expand the guidance contained in the third paragraph of current 7.00E, ``Acute leukemia,'' and the fifth paragraph of current 13.00C, ``Evaluation.'' In some of the proposed listings, we specify that the impairment is considered disabling until a particular point in time. If an individual has an impairment(s) that meets or equals a listing in this body system that does not contain such a specification, we provide that we will consider that individual to be under a disability until at least 3 years after onset of complete remission. We also explain what we do when the appropriate time period has passed.

Proposed 13.00IWhat Do These Terms in the Listings Mean?

We propose to replace the first two paragraphs and the first sentence of the third paragraph of current 13.00C, ``Evaluation,'' and provide additional definitions. The current section contains an adjudicative definition of ``distant metastases'' and ``metastases beyond the regional lymph nodes.'' We are not retaining this definition because our use of these terms in the proposed listings is consistent with current clinical practice.

In the proposed listings, we also differentiate between the terms ``inoperable'' and ``unresectable.'' With the proposed changes in the listing criteria, we would no longer need to define an unresectable tumor in terms of the nature of the surgery performed.
Proposed 13.00JCan We Establish the Existence of a Disabling Impairment Prior to the Date of the Evidence That Shows the Malignancy Satisfies the Criteria of a Listing?

This section corresponds to current 13.00E, ``Onset.'' We propose no substantive changes.
Proposed 13.00KHow Do We Evaluate Specific Malignant Neoplastic Diseases?

We incorporate and clarify current 7.00E, ``Acute leukemia,'' the last sentence of the third paragraph in current 13.00C, ``Evaluation,'' and provide guidance for evaluating additional malignant neoplastic disorders. The following is a detailed discussion of the information provided for the disorders in this section.

Proposed 13.00K(1)Lymphoma

In the first two paragraphs of this new section, we discuss the evaluation of indolent (nonaggressive) lymphomas. We explain that we will defer adjudication for an appropriate period after the initiation of therapy to determine whether the therapy will achieve its intended effect. We do not specify a particular time for this deferral because it will vary from case to case. We also provide a caution that changes in therapy based solely on patient or physician preference are not indicative of a failure to stabilize the disease. We also explain how the disease should be evaluated when stability has been achieved.

We have not retained the last sentence of the third paragraph of current 13.00C, ``Evaluation.'' This sentence states, ``In the evaluation of lymphomas, the tissue type and site of involvement are not necessarily indicators of the degree of impairment.'' We do not believe this guidance provides useful information for applying the criteria in proposed listing 13.05.

In the third paragraph we state that Hodgkin's disease that recurs more than 12 months after completing initial antineoplastic therapy will be evaluated as a new disease rather than as a recurrence. Proposed 13.00K(2)Leukemia

In paragraph (a), we expand the guidance in the first paragraph of current 7.00E, ``Acute leukemia,'' to indicate sources of additional diagnostic information. We also clarify the evidence needed to document recurrent disease by requiring one of the three laboratory findings named.

In paragraph (b), we provide guidance on documenting chronic myelogenous leukemia (CML). We have not included in this paragraph the guidance in the second paragraph of current 7.00E, which provides that the acute phase of CML should be considered under the requirements for acute leukemia. Instead, we have incorporated this guidance in proposed listing 13.06B1.

In paragraph (c), we provide guidance for documenting and evaluating chronic lymphocytic leukemia (CLL). Consistent with our effort to eliminate reference listings, this guidance incorporates the crossreferences in current listing 7.12 that are appropriate for evaluating CLL.

In paragraph (d), we explain that in cases of chronic leukemia, an elevated white cell count, in itself, is not ordinarily a factor in determining the severity of the impairment.

Proposed 13.00K(3)Macroglobulinemia or Heavy Chain Disease

This section replaces current listing 7.14, which is a reference listing. We propose no substantive changes in how we evaluate these disorders.

Proposed 13.00K(4)Bilateral Primary Breast Cancer

We are clarifying the statement in current listing 13.09D, ``bilateral breast carcinoma, synchronous or metachronous is usually primary in each breast'' by removing the suggestion that there are exceptions to this rule.
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Proposed 13.00K(5)Carcinomainsitu

In this new section, we explain why this type of carcinoma is not included when ``carcinoma'' is used in these listings.

Proposed 13.00K(6)Brain Tumors

In this new section, we explain that malignant tumors are evaluated under proposed listing 13.13 and benign tumors are evaluated under proposed listing 11.05. We also explain that we evaluate any complications of malignant brain tumors under the criteria for the affected body system.
Proposed 13.00LHow Do We Evaluate Malignant Neoplastic Diseases Treated by Bone Marrow or Stem Cell Transplantation?

In paragraphs (1) and (2) of this new section, we discuss how long we consider an individual disabled when that individual has leukemia, lymphoma, or multiple myeloma and undergoes bone marrow or stem cell transplantation.

In paragraph (3), we provide that all other malignant neoplastic diseases treated with bone marrow or stem cell transplantation must be evaluated under proposed listing 13.28, regardless of whether there is another listing that addresses that impairment. We explain that under proposed listing 13.28, how long we will consider the individual disabled depends on whether the individual has allogeneic or autologous transplantation. We define ``allogeneic'' and ``autologous,'' and discuss the criteria in proposed listing 13.28.

In paragraph (4), we discuss some of the factors we consider when we evaluate any residual impairment(s) that results from
transplantation.
How Are We Proposing to Change the Criteria in the Listings for Evaluating Malignant Neoplastic Diseases in Adults?
13.01 Category of Impairments, Malignant Neoplastic Diseases

We propose to delete current listing 13.15, ``Abdomen,'' because this disorder can be evaluated under other proposed listings. Current listings 13.15A, ``Generalized carcinomatosis,'' and 13.15C, ``Ascites with demonstrated malignant cells,'' represent malignancies that have spread to the abdomen from another site. We would evaluate these conditions under proposed listing 13.27, ``Primary site unknown after appropriate search for primary.'' Current listing 13.15B,
``Retroperitoneal cellular sarcoma not controlled by prescribed therapy,'' would be evaluated under proposed listing 13.04, ``Soft tissue sarcoma.''

In the following proposed listings, we:

The following is a detailed explanation of the proposed listing criteria.
Proposed Listing 13.02Soft Tissue Tumors of the Head and Neck (Except Salivary Glands13.06and Thyroid Gland13.07)

This listing corresponds to current listing 13.02, ``Head and neck.'' We propose to change the listing heading to ensure that only tumors of the soft tissue of the head and neck are considered under this listing. This change would allow us to delete the last two exceptions in the current heading (orbit or temporal fossa), as these are not soft tissue tumors.

Proposed listing 13.02A is substantively the same as current listing 13.02A. We propose to update the terminology to reflect the definitions used in the proposed listings.

In proposed listing 13.02B, which corresponds to current listing 13.02B, we propose to replace ``not controlled by prescribed therapy'' with ``[p]ersistent disease following initial multimodal antineoplastic therapy'' to clarify our intent.

Proposed listing 13.02C corresponds to current listing 13.02C. We propose to replace ``after radical surgery or irradiation'' with ``following initial antineoplastic therapy'' to recognize that other therapeutic modalities may be used. We also propose to exclude local vocal cord recurrences, because these recurrences have a good response to therapy.

Proposed listing 13.02D corresponds to current listing 13.02D. We propose no substantive change.

In proposed listing 13.02E, which corresponds to current listing 13.02E, we propose to delete the current criterion for epidermoid carcinoma in the posterior third of the tongue. Earlystage disease may be successfully treated. Laterstage disease can be assessed under the other criteria in this listing.

We propose to add the criterion in listing 13.02F to recognize the length and debilitating effects of multimodal treatment for head and neck tumors.

Proposed Listing 13.03Skin

We propose to combine current listing 13.03, ``Sarcoma of skin,'' and current listing 13.05, ``Malignant melanoma,'' so that all malignancies originating in the skin are evaluated under this listing. Accordingly, we propose to revise the heading by removing the reference to sarcoma.

Proposed listing 13.03A corresponds to current listing 13.03A, ``Angiosarcoma with metastases to regional lymph nodes or beyond.'' We propose to expand the provision to include all skin sarcomas and carcinomas because other skin malignancies of the severity described would also be disabling.

Proposed listing 13.03B corresponds to current listing 13.05. We propose to clarify that an additional primary malignancy at a different site is not considered recurrent disease. We are also adding a criterion for palpable nodal metastases.

We propose to move current listing 13.03B, ``Mycosis fungoides'' (a type of lymphoma), to proposed listing 13.05, ``Lymphoma,'' so that all lymphomas will be evaluated under the same listing.

Proposed Listing 13.04Soft Tissue Sarcoma

This listing proposes to update the heading of current listing 13.04, ``Sarcoma of soft parts,'' to recognize that ``soft tissue'' is a more common term than ``soft parts.'' We propose to add a criterion for regional or distant metastases, proposed listing 13.04A, to be consistent with the criteria for other malignant neoplastic diseases and to recognize the grave prognosis for these conditions. In proposed listing 13.04B, we define the current criterion ``not controlled by prescribed therapy'' similar to the way we defined it in other listings, such as proposed listing 13.02B.
Proposed Listing 13.05Lymphoma (Including Mycosis Fungoides, but Excluding TCell Lymphoblastic Lymphoma13.06)

This listing corresponds to current listing 13.06. We propose to change the heading from ``Lymph nodes'' to ``Lymphoma'' to more accurately reflect the disease. We provide that we will evaluate Tcell lymphoblastic lymphoma under the listing for acute leukemia. This is because the course, treatment, and outcome of this lymphoma are more similar to acute leukemia than to other lymphomas. We also provide a crossreference to the explanatory paragraphs in proposed 13.00K(1). [[Page 59313]]

We evaluate both Hodgkin's disease and nonHodgkin's lymphoma under current listing 13.06A. We propose to separate and clarify the criteria for each of these diseases. Proposed listing 13.05A would provide criteria for evaluating nonHodgkin's lymphoma; proposed listing 13.05B would provide criteria for Hodgkin's disease. For each of these disorders, we would also clarify the current criteria by replacing the phrase ``progressive disease not controlled by prescribed therapy'' in the current listing with clearer language.

In proposed listing 13.05C, we would provide that a lymphoma treated by bone marrow or stem cell transplantation is considered disabling until at least 12 months from the date of transplantation. After this period, we will evaluate any residual impairment(s) under the criteria for the affected body system.

We propose to delete current listing 13.06B, ``Metastatic carcinoma in a lymph node (except for epidermoid carcinoma in a lymph node in the neck) where the primary site is not determined after adequate search.'' We propose to evaluate this impairment under proposed listing 13.27, ``Primary site unknown after appropriate search for primary.'' We also propose to delete current listing 13.06C. We would evaluate epidermoid carcinoma in a lymph node in the neck under proposed listing 13.02, ``Soft tissue tumors of the head and neck.''

Proposed Listing 13.06Leukemia

We propose to revise current listing 7.11, ``Acute leukemia,'' and current listing 7.12, ``Chronic leukemia.''

In proposed listing 13.06A, we provide that an individual with acute leukemia (including Tcell lymphoblastic lymphoma) will be considered under a disability until at least 24 months from the date of diagnosis or relapse, or at least 12 months from the date of bone marrow or stem cell transplantation, whichever is later. After the appropriate period, we will evaluate any residual impairment(s) under the criteria for the affected body system.

Under the current listing, we find an individual with acute leukemia disabled for 2\1/2\ years from the time of the initial diagnosis. We are proposing to shorten this period to 2 years because of improvement in the treatment of this disorder. However, as with other proposed listings, we provide that we would permit a longer period when the facts warrant it. We would also recognize that a relapse of acute leukemia is as significant as the initial diagnosis.

The criterion we propose for bone marrow or stem cell transplantation in cases of acute leukemia is similar to the proposed transplantation criteria for other diseases. Unlike those diseases, however, we would not reevaluate an individual with acute leukemia who undergoes bone marrow or stem cell transplantation 12 months after transplant if that date is earlier than 24 months after onset or relapse. We provide this option for this disease because of the disease course and the high rate of infection and other complications that occur in individuals with acute leukemia who undergo bone marrow or stem cell transplantation.

Proposed listing 13.06B, ``Chronic myelogenous leukemia,'' would replace current listing 7.12. The current listing is a reference listing. Rather than replace the entire listing with guidance in the preface, we propose to provide separate evaluation criteria for CML. Consistent with our guidance in the second paragraph of current 7.00E, the proposed criteria for the accelerated or blast phase of CML are the same as proposed listing 13.06A.

We propose to retain those references that are appropriate for evaluating chronic lymphocytic leukemia in 13.00K(2)(c).
Proposed Listing 13.07Multiple Myeloma (Confirmed by Appropriate Serum or Urine Protein Electrophoresis and Bone Marrow Findings)

In this proposed listing, we delete the specific findings in current listing 7.16AD and substitute the criterion ``[f]ailure to respond or progressive disease following initial antineoplastic therapy.'' Our intent is to clarify that this listing includes all listinglevel manifestations of this disease. We also propose that an individual with multiple myeloma who undergoes bone marrow or stem cell transplantation will be considered disabled until at least 12 months from the date of transplantation. After that time, we will evaluate any residual impairment(s) under the criteria for the affected body system. Proposed Listing 13.08Salivary Glands

This listing corresponds to current listing 13.07. We propose no substantive changes.

Proposed Listing 13.09Thyroid Gland

We propose to expand current listing 13.08 to include anaplastic (undifferentiated) carcinoma. This type of carcinoma has a very poor prognosis. We also propose to replace the term ``not controlled by prescribed therapy'' used in the current listing with ``progressive despite radioactive iodine therapy'' to clarify our intent. Proposed Listing 13.10Breast

This listing corresponds to current listing 13.09. In listing 13.10A, we propose to revise the criterion in current listing 13.09B, ``Inflammatory carcinoma,'' to include other types of locally advanced carcinoma.

In listing 13.10B, ``Carcinoma with distant metastases,'' we propose to revise current listing 13.09D by deleting the parenthetical statement ``bilateral breast carcinoma, synchronous or metachronous, is usually primary in each breast.'' Instead, we propose to provide guidance about evaluating bilateral breast cancer in proposed 13.00K(4). As indicated in our discussion of that section, we are clarifying this guidance by removing the suggestion that there are exceptions to this rule.

In proposed listing 13.10C, which would replace current listing 13.09C, we propose to replace the term ``controlled by prescribed therapy'' used in the current listing with ``that remits with antineoplastic therapy'' to clarify our intent.

We propose to delete current listing 13.09A, ``inoperable carcinoma,'' to avoid confusion about what this term means for this malignancy. We can evaluate cases in which breast cancer is inoperable under other criteria in the proposed listing. We also propose to delete current listing 13.09E, ``Sarcoma with metastases anywhere.'' We would evaluate this impairment under proposed listing 13.04, ``Soft tissue sarcoma.''

Proposed Listing 13.11Skeletal System

This listing would replace current listing 13.10. We propose to expand the listing to include tumors of the mandible that are currently evaluated under listing 13.11. In proposed listings 13.11A, 13.11B, and 13.11C, we would revise current listing 13.10A to clarify when these tumors are of listinglevel severity. In listing 13.11D, we propose to provide that we will consider all other malignant tumors originating in bone with multimodal antineoplastic therapy disabling until 12 months from the date of diagnosis. Consistent with the changes we have proposed for other listings, after that period, any residual impairment(s) would be evaluated under the criteria for the affected body system. With this criterion, we recognize the length and debilitating effects of multimodal treatment for these tumors. [[Page 59314]]
Proposed Listing 13.12 Maxilla, Orbit, or Infratemporal Fossa

This listing corresponds to current listing 13.11. As noted above, we propose to evaluate tumors of the mandible under proposed listing 13.11. Proposed listings 13.12A and 13.12B correspond to current listings 13.11A and 13.11B and are substantively unchanged.

In proposed listing 13.12C, we consolidate the disease sites in current listings 13.11C, 13.11D, 13.11E, and 13.11F.

Proposed Listing 13.13Nervous System

This listing incorporates the criteria for malignant brain tumors in current listing 11.05, ``Brain tumors,'' in the neurological body system, and replaces current listing 13.12, ``Brain or spinal cord.'' We propose to expand the listings to include tumors of the spinal cord, spinal nerve roots, and the peripheral nervous system. We also propose to include tumors of the central nervous system that are not specifically named.

Under listing 13.13A, we propose to evaluate central nervous system malignant neoplasms; that is, those affecting the brain or spinal cord. In proposed listing 13.13A1, we list and revise the criteria for the impairments named in current listing 11.05A. We propose to revise the reference to medulloblastoma to include other primitive neuroectodermal tumors (PNETs) and to require documented metastases for this type of tumor. Advances in treatment have significantly improved the overall prognosis of this disease, so that in the absence of metastases many individuals do well. We can evaluate medulloblastomas or other PNETs that have not metastasized, as well as the malignant brain tumors listed in current listing 11.05B, under proposed listing 13.13A2.

We also propose to add diffuse intrinsic brain stem gliomas in proposed listing 13.13A1. We are proposing to require that the impairment be ``diffuse'' and ``intrinsic'' because progress in medical diagnostic tools has now allowed for effective treatment of individuals with localized brain stem tumors.

In proposed listing 13.13B, we provide criteria for evaluating malignant tumors of peripheral nerves and spinal roots.

Proposed listing 13.13C, for metastatic carcinoma to the brain or spinal cord, is substantively the same as current listing 13.12A. We propose to clarify that this listing includes ``epidural metastases.''

We propose to delete current listing 13.12B, which provides cross references to listings 11.05 and 11.08, as we have incorporated this guidance in the other sections of this proposed listing and 13.00K(6). Proposed Listing 13.14Lungs

This listing corresponds to current listing 13.13. In proposed listing 13.14A, we consolidate current listings 13.13A, 13.13B, 13.13D, and 13.13E. This change is consistent with current medical terminology, which no longer distinguishes between the types of nonsmallcell carcinoma. We also propose to remove metastases to the hilar nodes from the listing criteria as metastases to the hilum can often be surgically excised.

We are redesignating current listing 13.13C as proposed listing 13.14B. We propose no substantive changes.

Proposed Listing 13.15Pleura or Mediastinum

This listing corresponds to current listing 13.14. Proposed listing 13.15A is the same as current listing 13.14A. In proposed listing 13.15B, which corresponds to current listing 13.14C, we provide new language that would clarify the phrase ``not controlled by prescribed therapy'' used in the current listing.

We propose to delete current listing 13.14B, ``Malignant tumors, metastatic to pleura.'' This malignancy would be evaluated under proposed listing 13.27, ``Primary site unknown.''

Proposed Listing 13.16Esophagus or Stomach

This listing corresponds to current listing 13.16. Proposed listing 13.16A is the same as current listing 13.16A. In proposed listing 13.16B, we would consolidate current listings 13.16B through 13.16E to clarify that all of those criteria relate to carcinoma or sarcoma of the stomach. We would also provide new language to clarify the phrase ``not controlled by prescribed therapy'' used in current listing 13.16C.

Proposed Listing 13.17Small Intestine

This listing corresponds to current listing 13.17. In proposed listing 13.17A, we expand the criterion in current listing 13.17B, for recurrent malignancies, to indicate that inoperable and unresectable malignancies are also of listinglevel severity. We would also provide new language to clarify the phrase ``not controlled by prescribed therapy'' used in current listing 13.17C. Proposed listing 13.17B corresponds to current listing 13.17A, and is substantively unchanged. Proposed Listing 13.18Large Intestine (From Ileocecal Valve to and Including Anal Canal)

This listing corresponds to current listing 13.18. We propose to delete the phrase ``carcinoma or sarcoma'' from the heading of this listing because sarcomas of the large intestine are extremely rare. In proposed listing 13.18A, we consolidate current listings 13.18A and 13.18C and clarify that these criteria apply to adenocarcinoma. In proposed listing 13.18B, we provide that squamous cell carcinoma of the anus will not be found to meet the listing unless it is recurrent after surgery. Advances in treatment have made chemotherapy and radiation the treatment of choice for this disorder. However, good results can be achieved through surgery if the preferred treatment is not effective. Proposed listing 13.18C is the same as current listing 13.18B. Proposed Listing 13.19Liver or Gallbladder

This listing corresponds to current listing 13.19. We propose to clarify that the listing applies only to malignancies that originate in the liver, gallbladder, or bile ducts. We will evaluate metastases to the liver from other sites under the criteria for the site of origin or under the criteria of proposed listing 13.27, when the primary site is unknown.

Proposed Listing 13.20Pancreas

This listing corresponds to current listing 13.20. We are not proposing any changes, other than adding ``inoperable'' conditions to the second listing criterion. We would make this change to reflect the revised definitions used in these listings.

Proposed Listing 13.21Kidneys, Adrenal Glands, or Ureters

This listing corresponds to current listing 13.21. In proposed listing 13.21A, we would expand the criteria to include inoperable and recurrent tumors. Proposed listing 13.21B consolidates current listings 13.21B and 13.21C. We propose to eliminate the modifier
``hematogenous'' used in current listing 13.21B because metastases by lymphatic spread or by direct extension carry the same poor prognosis. Proposed Listing 13.22Urinary Bladder

This listing corresponds to current listing 13.22. We propose to delete current listing 13.22E, which provides
[[Page 59315]]
for the evaluation of renal impairment following total cystectomy under the criteria in listing 6.02, because it is a reference listing. Proposed Listing 13.23Cancers of the Female Genital Tract

In this listing, we propose to incorporate and revise current listings 13.25, ``Uterus,'' 13.26, ``Ovaries,'' 13.28, ``Uterine (Fallopian) tubes, and 13.30, ``Vulva.''

In proposed listings 13.23A, ``Uterus (corpus),'' and 13.23B ``Uterine cervix,'' we would replace the current criteria in listings 13.25B, ``Recurrent after total hysterectomy,'' and 13.25C, ``Total pelvic exenteration,'' with ``Persistent or recurrent following initial antineoplastic therapy.'' With this revision, we recognize changes in treatment for these disorders. In proposed 13.23C, ``Vulva,'' we provide criteria in addition to the criteria for distant metastases used in the current listing.

In proposed 13.23D1, `` Extending to the serosa or beyond,'' we replace the criteria in current listings 13.28A, ``Unresectable,'' and 13.28B, ``Metastases to regional lymph nodes.'' Tumors extending to the serosa are considered to be unresectable for the purposes of this listing; tumors extending beyond the serosa equate to tumors that have metastasized to the regional lymph nodes. We also propose adding criteria to evaluate fallopian tube tumors when the initial antineoplastic therapy has not achieved the desired effect.

In proposed 13.23E, ``Ovaries,'' we propose to separate germ cell and nongerm cell tumors. In proposed 13.23E1, which provides the criteria for evaluating nongerm cell tumors, we would expand the criteria in current listing 13.26 to reflect advances in diagnostic techniques and treatment. We provide criteria for evaluating germ cell tumors in proposed listing 13.23E2.

Proposed Listing 13.24Prostate Gland

In this listing, which corresponds to current listing 13.23, we propose to provide new language to clarify the phrase ``not controlled by prescribed therapy'' used in the current listing.

Proposed Listing 13.25Testicles

This listing corresponds to current listing 13.24. We propose to delete current listing 13.24A, for choriocarcinoma, in recognition of advances in the treatment of this disease.

Proposed Listing 13.26Penis

This listing corresponds to current listing 13.29. We have clarified the listing to explicitly include metastases to or beyond the regional lymph nodes.
Proposed Listing 13.27Primary Site Unknown After Appropriate Search for Primary

We propose to provide for the evaluation of the occasional case in which metastases have been appropriately verified but the site of the primary malignancy cannot be determined. The proposed listing specifically excludes solitary squamous cell carcinoma in the neck, as this type of metastasis is often amenable to treatment.
Proposed Listing 13.28Malignant Neoplastic Diseases Treated by Bone Marrow or Stem Cell Transplantation

In this listing, we propose to indicate how long we consider individuals who undergo bone marrow or stem cell transplantation disabled. The criterion for allogeneic transplantation, proposed listing 13.28A, is consistent with the criterion in proposed listing 7.06. This criterion states that we consider the individual disabled until at least 12 months from the date of transplantation. For autologous transplantation, we would consider the individual to be under a disability until at least 12 months from the date of the first treatment under the treatment plan that includes transplantation. We use an earlier date to begin the 12month period for autologous transplantation because the recovery period after this type of transplantation is generally shorter than for allogeneic
transplantation. In both cases, we will evaluate any residual impairment(s) after the applicable period under the criteria for the affected body system.
How Are We Proposing to Change the Preface in the Listings for Evaluating Hematological Disorders in Children?

107.00 Hematological Disorders

As in proposed 7.00 in the adult rules, we propose to change the name of this body system to ``Hematological Disorders'' and to move the guidance contained in current 10

FOR FURTHER INFORMATION CONTACT

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