[Federal Register Volume 66, Number 228 (Tuesday, November 27, 2001)]
[Proposed Rules]
[Pages 59306-59328]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-29224]



[[Page 59305]]

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Part II





Social Security Administration





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20 CFR Part 404



Revised Medical Criteria for Evaluating Hematological Disorders and 
Malignant Neoplastic Diseases; Proposed Rule

  Federal Register / Vol. 66 , No. 228 / Tuesday, November 27, 2001 / 
Proposed Rules  

[[Page 59306]]


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SOCIAL SECURITY ADMINISTRATION

20 CFR Part 404

[Reg. No. 4]
RIN 0960-AD67


Revised Medical Criteria for Evaluating Hematological Disorders 
and Malignant Neoplastic Diseases

AGENCY: Social Security Administration.

ACTION: Proposed rules.

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SUMMARY: We are proposing to revise the criteria in the Listing of 
Impairments (the listings) that we use to evaluate claims involving 
hematological disorders and malignant neoplastic diseases at the third 
step of our sequential evaluation processes for adults and children 
under title II and title XVI of the Social Security Act (the Act). The 
proposed revisions reflect advances in medical knowledge, treatment, 
and methods of evaluating hematological disorders and malignant 
neoplastic diseases.

DATES: To be sure your comments are considered, we must receive them by 
January 28, 2002.

ADDRESSES: Give us your comments using our Internet site facility 
(i.e., Social Security Online) at: http://www.ssa.gov/regulations/. If 
that facility is unavailable or not desired, you may send us your 
comments: by e-mail to [email protected]; by telefax to (410) 966-
2830; or, by letter to the Commissioner of Social Security, P.O. Box 
17703, Baltimore, Maryland 21235-7703. You may also deliver them to the 
Office of Process and Innovation Management, Social Security 
Administration, L2109 West Low Rise Building, 6401 Security Boulevard, 
Baltimore, Maryland 21235-6401, between the 8:00 a.m. and 4:30 p.m. on 
regular business days. Comments are posted on our Internet site, or you 
may inspect them on regular business days by making arrangements with 
the contact person shown in this preamble.
    Electronic Version: The electronic file of this document is 
available on the date of publication in the Federal Register on http://www.access.gpo.gov/su_docs/aces/aces140.html. It is also available on 
the Internet site for SSA (i.e., Social Security Online): http://www.ssa.gov/regulations/. Electronic copies of public comments may also 
be found on this site.

FOR FURTHER INFORMATION CONTACT: Suzanne DiMarino, Social Insurance 
Specialist, Office of Process and Innovation Management, Social 
Security Administration, L2109 West Low Rise, 6401 Security Boulevard, 
Baltimore, Maryland 21235-6401, (410) 965-1769 or TTY (410) 966-5609. 
For information on eligibility or filing for benefits, call our 
national toll-free number, 1-800-772-1213 or TTY 1-800-325-0778, or 
visit our Internet web site, SSA Online, at www.ssa.gov.

SUPPLEMENTARY INFORMATION:

What Programs Would Be Affected by These Proposed Regulations?

    These proposed regulations would affect disability determinations 
and decisions we make for individuals under title II and title XVI of 
the Act. In addition, to the extent that Medicare and Medicaid 
eligibility are based on title II and title XVI eligibility, these 
proposed regulations also would affect the Medicare and Medicaid 
programs.

Who Can Get Disability Benefits?

    Under title II of the Act, we provide for the payment of disability 
benefits to three groups of individuals:
     Workers insured under the Act.
     Children of insured workers.
     Widows, widowers, and surviving divorced spouses of 
insured individuals.
    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 * * *
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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:
     Renumber the listings in part A and part B for the 
hematological disorders and malignant neoplastic diseases body systems. 
To the extent possible, we number the listings in part B to correspond 
with listings addressing the same impairments in part A.
     Reorganize these listings by grouping related impairments 
under broader medical diagnostic categories. For example, we would 
group chronic thrombocytopenia (current listings 7.06 and 107.06) and 
coagulation defects (current listings 7.08 and 107.08) under the 
category ``Disorders of hemostasis'' (proposed listings 7.03 and 
107.03); and we would group sarcoma of skin (current listing 13.03) and 
malignant melanoma (current listing 13.05) under the category ``Skin'' 
(proposed listing 13.03).
     Further reorganize these listings to place all listings 
for malignant neoplastic diseases under that body system. To do this, 
we would move the criteria for acute leukemia, chronic leukemia, 
myeloma, and malignant brain tumors, current listings 7.11, 7.12, 7.16, 
11.05, 107.11, and 111.05, to proposed listings 13.06, 13.07, 13.13, 
113.06 and 113.13. We would also move the guidance for evaluating 
macroglobulinemia or heavy chain disease, current listing 7.14, to 
section 13.00K(3) of the proposed preface. The current listing for this 
disorder is a reference listing. In accordance with the discussion 
below, we propose to eliminate reference listings.
     Replace reference listings in these areas with guidance in 
the preface. Reference listings are listings that are met by satisfying 
the criteria of another listing. For example, current listing 7.16B, 
for myeloma with evidence of renal impairment, is a reference listing 
that requires evaluation under current listing 6.02, for impairment of 
renal function. Instead of using reference listings, we propose to 
provide general guidance in the preface to each of these body systems 
stating that resulting impairments should be evaluated under the 
criteria for the affected body system. Where appropriate, we would also 
provide references to specific listings. For example, in proposed 
section 13.00K(3) we indicate that macroglobulinemia or heavy chain 
disease should be evaluated under the criteria of proposed listings 
7.03 or 7.04, or under the criteria of any other affected body system.
    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 7.00A--What Do We Consider When We Evaluate Hematological 
Disorders Under These Listings?

    In this new section, we list the factors we consider.

Proposed 7.00B--What Documentation Do We Need?

    To clarify the first sentence of current 7.00B, ``Chronicity,'' we 
explain that we

[[Page 59308]]

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 7.00C--How 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 7.00D--How 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 7.00E--How 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 5-month or 12-month 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 7.00F--What Do These Terms in the Listings Mean?

    We propose to define the terms ``persistent'' and ``repeated'' or 
``repeatedly'' in the hematological disorders listings.

Proposed 7.00G--How 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 7.00H--How Do We Evaluate non-malignant Hematological 
Disorders Treated by Allogeneic Bone Marrow or Stem Cell 
Transplantation?

    We provide that non-malignant 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 oxygen-carrying 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 listing-level 
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 7.02--Sickle Cell Disease or One of its Variants

    This proposed listing has three separate evaluation criteria. 
Proposed listing 7.02A, documented painful (vaso-occlusive) 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 6-month period are indicative of listing-level 
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 7.03--Disorders 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 7.03A--Chronic Thrombocytopenia (Due to Any Cause)

    This listing corresponds to current listing 7.06. We propose the 
following changes:
     In proposed listing 7.03A1, we indicate that chronic 
thrombocytopenia with platelet counts repeatedly below 10,000/
mm3 despite prescribed therapy is, by itself, an impairment 
that would preclude an individual from performing any gainful activity.
     In proposed listing 7.03A2, we require platelet counts 
repeatedly below 20,000/mm3 instead of the current criterion 
of 40,000/mm3. We propose this change because the incidence 
of spontaneous bleeding episodes increases significantly when the 
platelet count is below 20,000/mm3. Some individuals whose 
platelet counts are 20,000/mm3 or higher may still be 
limited or restricted, but many of these individuals will not be 
precluded from engaging in any gainful activity. Therefore, we will 
evaluate these individuals on a case-by-case basis.
     In proposed listing 7.03A2, we also propose to clarify the 
reference to transfusion and change the frequency requirements in 
current listing 7.06A. We clarify the reference to transfusion by 
specifying red cell or platelet transfusion. We propose this revision 
to reflect common medical practice. We also propose to change the 
frequency requirement from one episode of bleeding within the 5 months 
prior to adjudication to at least three episodes of bleeding in a 
consecutive 12-month period. We propose this revision because one 
episode of bleeding in 5 months is not sufficient to establish that the 
impairment has lasted or can be expected to last for at least 12 
months.
     We propose to replace the criterion in current listing 
7.06B, intracranial bleeding within 12 months prior to adjudication, 
with guidance in 7.00G(3)(c) indicating that intracranial bleeding 
should be evaluated under listing 11.04. We are proposing this change 
to be consistent with the criteria in other listings that evaluate 
intracranial bleeding (for example, listing 4.10D) and to recognize 
that improved diagnostic techniques can detect very minor bleeds that 
have no functional impact. We are placing this guidance in the preface, 
rather than retaining it as a listing criterion, as part of our effort 
to eliminate reference listings.

Proposed Listing 7.03B--Hemophilia

    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 7.03C--Other 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

[[Page 59310]]

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 7.03D--Hypercoagulable States (Deficiency of Anti-
coagulant Proteins Such as C, Protein S, And Anti-thrombin, 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 7.04--Aplastic 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 cross-reference 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 7.05--Chronic Granulocytopenia (Due to Any Cause)

    This listing corresponds to current listing 7.15. We propose three 
revisions to the criteria:
     Changing the required neutrophil counts from repeatedly 
below 1000/mm3 to repeatedly below 500/mm3. We 
propose this change because the incidence of infection increases 
significantly when the neutrophil count is below 500/mm3. 
Some individuals whose neutrophil counts are 500/mm3 or 
higher may still be limited or restricted, but many of these 
individuals will not be precluded from engaging in any gainful 
activity. Therefore, we will evaluate these individuals on a case-by-
case basis.
     Changing the infection criterion in listing 7.05B to be 
consistent with proposed listing 7.04B.
     Changing the required frequency of treatment in listing 
7.05B to be consistent with proposed listing 7.04B.

Proposed Listing 7.06--Non-Malignant Hematological Diseases Treated by 
Allogeneic Bone Marrow or Stem Cell Transplantation (see 7.00H)

    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 13.00A--What 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 13.00B--What 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 13.00C--How 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 13.00D--What Evidence Do We Need?

    We propose to expand the guidance in current 13.00B, 
``Documentation,'' by:
     Explaining that when the primary site cannot be 
identified, we will use

[[Page 59311]]

documentation of the site(s) of metastasis to evaluate the impairment 
under proposed listing 13.27.
     Clarifying that we consider biopsies and needle 
aspirations to be ``operative procedures.''
     Using the more general term ``pathology report'' instead 
of ``the report of the gross and microscopic examination of the 
surgical specimen.'' We are making this change to recognize that a 
report of the gross examination is not always required and to recognize 
that a microscopic examination of appropriate body fluids may be used 
as an alternative to the gross and microscopic examination of the 
surgical specimen.

Proposed 13.00E--When 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 13.00F--How 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 13.00G--How 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 13.00H--How 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 13.00I--What 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 13.00J--Can 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 13.00K--How 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 (non-aggressive) 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 
cross-references 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.

[[Page 59312]]

Proposed 13.00K(5)--Carcinoma-in-situ

    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 13.00L--How 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:
     Take into account medical advances in the detection, 
treatment, control and cure of malignant neoplastic diseases.
     Recognize that in some situations the effects of therapy 
for these disorders can be disabling.
     Provide for the evaluation of residual impairments.
    The following is a detailed explanation of the proposed listing 
criteria.

Proposed Listing 13.02--Soft Tissue Tumors of the Head and Neck (Except 
Salivary Glands--13.06--and Thyroid Gland--13.07)

    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. Early-stage disease may 
be successfully treated. Later-stage 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 13.03--Skin

    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 13.04--Soft 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 13.05--Lymphoma (Including Mycosis Fungoides, but 
Excluding T-Cell Lymphoblastic Lymphoma--13.06)

    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 T-cell 
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 
cross-reference to the explanatory paragraphs in proposed 13.00K(1).

[[Page 59313]]

    We evaluate both Hodgkin's disease and non-Hodgkin'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 non-Hodgkin'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 13.06--Leukemia

    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 T-cell 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 13.07--Multiple 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 7.16A-D 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 
listing-level 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 13.08--Salivary Glands

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

Proposed Listing 13.09--Thyroid 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 13.10--Breast

    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 13.11--Skeletal 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 listing-level 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 13.13--Nervous 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 13.14--Lungs

    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 non-small-cell 
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 13.15--Pleura 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 13.16--Esophagus 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 13.17--Small 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 listing-level 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 13.18--Large 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 13.19--Liver 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 13.20--Pancreas

    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 13.21--Kidneys, 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 13.22--Urinary 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 13.23--Cancers 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 non-germ cell tumors. In proposed 13.23E1, which provides the 
criteria for evaluating non-germ 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 13.24--Prostate 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 13.25--Testicles

    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 13.26--Penis

    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 13.27--Primary 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 13.28--Malignant 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 12-month 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 107.00C, ``Acute leukemia,'' to proposed 
113.00K(2)(a).
    Except for minor changes to refer to children, we have repeated 
much of the preface of proposed 7.00 in the preface to proposed 107.00. 
This is because the same basic rules for establishing and evaluating 
the existence and severity of hematological impairments in adults also 
apply to children. Because we have already described these provisions 
under the explanation of proposed 7.00, the following discussions 
describe only those provisions that are unique to the childhood rules 
or that require further explanation.

Proposed 107.00C--How Do We Evaluate Impairments That Do Not Meet One 
of the Hematological Disorders Listings?

    In this section, we use the definition of disability for children 
who claim SSI payments.

Proposed 107.00G--How Do We Evaluate Specific Hematological Disorders?

    In this section, we incorporate and revise the guidance in current 
107.00A, ``Sickle cell disease,'' and 107.00B, ``Coagulation defects,'' 
and provide guidance for evaluating additional hematological disorders 
in children. Proposed 107.00G(1), ``Anemia,'' 107.00G(3), ``Disorders 
of hemostasis,'' and 107.00G(4), ``Hematological malignancies,'' 
contain the same information as the adult sections that address these 
disorders.

Proposed 107.00G(2)--Hemolytic Anemias

Proposed 107.00G(2)(a)--Sickle Cell Disease or One of Its Variants

    In proposed 107.00G(2)(a)(i), which is the same as proposed 
7.00G(2), we incorporate and expand the guidance from the first two 
paragraphs of current 107.00A.
    In proposed 107.00G(2)(a)(iv), we explain that, to meet the 
criterion in proposed listing 107.02A2, hospitalizations must be due to 
complications of sickle cell disease and that the most common 
complications requiring hospitalization are shown in the listing. 
However, we also provide that hospitalizations for complications other 
than the ones listed can be determined to be of equal clinical 
significance and thus be medically equal to the ones listed.
    We propose to delete the guidance in the third and fourth 
paragraphs of current 107.00A. The third paragraph summarizes the 
listing criteria but provides no additional information on how to 
evaluate the disorder. The fourth paragraph lists examples of major 
visceral episodes, a criterion of current listing 107.05B, the current 
childhood listing for sickle cell disease. We propose to delete this 
criterion. We explain the reasons for this proposed deletion under the 
explanation of proposed listing 107.02A, the listing that corresponds 
to current listing 107.05B.

[[Page 59316]]

Proposed 107.00G(2)(b)--Thalassemia

    In this new section, we propose to provide guidance on how to 
document this disorder. We discuss some of the residual impairments 
that result from this disorder and indicate that we evaluate these, or 
any other, residual impairments resulting from this disorder under the 
criteria for the affected body system.

Proposed 107.00G(2)(c)--Prophylactic Transfusion Programs

    In this new section, we propose to explain why, for children on 
prophylactic transfusion programs, we will not use pre-transfusion 
hemoglobin values to determine if the child's sickle cell disease or 
thalessmia major meet the requirements of proposed listings 107.02A or 
107.02B.

Proposed 107.00G(2)(d)--Chronic Iron Overload

    In this section, which is similar to proposed 7.00G(5), we propose 
to provide that residuals from chronic iron overload due to chronic 
transfusion programs will be evaluated under the criteria for the 
affected body system. In proposed 7.00G(5), we include guidance on 
evaluating residuals from chronic iron overload due to hereditary 
hemochromatosis as well as chronic transfusion programs. We have not 
repeated the guidance on hereditary hemochromatosis in the childhood 
rules because residuals from this disorder are very rare in children. 
As the proposed childhood guidance addresses only residuals from 
chronic iron overload due to chronic transfusion programs, we believe 
it is appropriate to place this guidance in the same section as the 
guidance on prophlylactic transfusion programs, rather than in a 
separate section.

How Are We Proposing To Change the Criteria in the Listings for 
Evaluating Hematological Disorders in Children?

107.01  Category of Impairments, Hematological Disorders

    We propose to move current listing 107.11, ``Acute leukemia,'' to 
the malignant neoplastic diseases body system (proposed listing 
113.06). We also propose to add new listings 107.05, ``Chronic 
granulocytopenia (due to any cause),'' and 107.06, ``Non-malignant 
hematological diseases treated by allogeneic bone marrow or stem cell 
transplantation,'' because they are applicable to children as well as 
adults. We are not explaining these new listings here as they are 
identical to, and explained in, the corresponding adult listings. We 
also propose to renumber these listings to be consistent with the adult 
listings. Because of this, the numbers of the proposed childhood 
listings are not consecutive.

Proposed Listing 107.02--Anemia

    In proposed listings 107.02A and 107.02B, we incorporate current 
listings 107.05, ``Sickle cell disease,'' and 107.03, ``Hemolytic 
anemia (due to any cause).'' In proposed listing 107.02C, we add 
criteria to evaluate aplastic anemia. We discuss the provisions of 
proposed listing 107.02 below.

Proposed Listing 107.02A--Sickle Cell Disease or One of Its Variants

    Proposed listing 107.02A1, for documented painful vaso-occlusive 
crises, would replace current listing 107.05A. The proposed criteria 
provide more specificity and clarity than the criterion ``Recent, 
recurrent, severe'' used in the current listing. We also propose to 
delete the parenthetical list of examples of vaso-occlusive crises to 
avoid any confusion about the types of crises that can be considered.
    Proposed listing 107.02A2 would replace current listing 107.05C and 
partially replace current listing 107.05B. Many children with sickle 
cell disease are hospitalized on a precautionary basis. To ensure that 
the hospitalizations considered under the listing are due to 
complications of the disease, and are not precautionary, we list the 
most common complications that result in hospitalizations. We provide, 
in proposed 107.00G(2)(a)(iv), that hospitalizations for other 
complications can be used to determine whether a complication medically 
equals the listings.
    We propose to delete the criterion for a ``major visceral 
complication'' from current listing 107.05B and, as indicated above, to 
delete the fourth paragraph of current 107.00A which provides examples 
of ``major visceral episodes.'' If a major visceral episode results in 
hospitalization, we will consider it under proposed listing 107.02A2. 
If an episode results in another impairment(s), we will evaluate the 
residual impairment(s) under the criteria for the affected body 
system(s). However, the kinds of complications described in the fourth 
paragraph of current 107.00A, as well as those in current listing 
107.05C, may be acute and resolve completely with treatment. The fact 
that a child has had one episode is not sufficient to establish that 
the child has been, or will be, disabled for a continuous period of at 
least 12 months.
    Proposed listing 107.02A3, requiring chronic anemia, would revise 
the criterion in current listing 107.05D to reflect 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 with an impairment of listing-level severity.
    Consistent with our changes in the adult rules, we would not retain 
the word ``severe'' used in current listing 107.05D in our proposed 
criterion for sickle cell disease with chronic anemia. We explain our 
reasons for deleting this word in our discussion of proposed listing 
7.02.

Proposed Listing 107.02B--Other Hemolytic Anemias

    In this listing, we propose to revise the criteria in current 
listing 107.03 to provide a more accurate measure of severity. Children 
whose hematocrit persists at 26 percent or less despite prescribed 
therapy will not necessarily have marked and severe functional 
limitations. Additionally, we propose to delete the requirement for 
reticulocyte counts since a reticulocyte count is not needed to 
determine whether the impairment is of listing-level severity and such 
counts may not be included in the laboratory findings.

Proposed Listing 107.02C--Aplastic Anemia

    This listing contains the same criteria as proposed listing 7.04.

Proposed listing 107.03--Disorders of Hemostasis

    For this listing, we use the same criteria as proposed listing 
7.03. The following is a discussion of how these proposed criteria 
relate to the current criteria.
    Proposed listing 107.03A, ``Chronic thrombocytopenia (due to any 
cause),'' replaces current listing 107.06, ``Chronic idiopathic 
thrombocytopenic purpura of childhood.'' The proposed criteria are more 
accurate measures of severity. The current criterion requires platelet 
counts of 40,000/mm3 or less despite therapy or recurrent 
upon withdrawal of treatment, but platelet counts at this level will 
not necessarily result in marked and severe functional limitations. We 
would also delete the specification of thrombocytopenic purpura, 
broadening the listing to address chronic thrombocytopenia due to any 
cause.
    Proposed listings 107.03B, ``Hemophilia,'' and 107.03C, ``Other 
hypocoagulable states (such as von Willebrand's disease or 
thrombasthenia),'' would replace current listing 107.08, ``Inherited 
coagulation disorder.'' The proposed criteria provide more specificity 
and

[[Page 59317]]

clarity than the criterion in current listing 107.08A, ``repeated 
spontaneous or inappropriate bleeding.'' We propose to move the 
criterion in current listing 107.08B, for hemarthrosis with joint 
deformity, to proposed 107.00G(3)(c). The current listing does not 
specify the level of joint deformity required. We propose to make it 
clear that only serious joint deformity resulting in listing-level 
functional deficit will constitute an impairment of listing-level 
severity. To do this, we propose that this complication be evaluated 
under current listing 101.02. Because this guidance would result in a 
reference listing, we are placing it in the preface.

How Are We Proposing To Change the Preface in the Listings for 
Evaluating Malignant Neoplastic Diseases in Children?

113.00  Malignant Neoplastic Diseases

    We propose to delete the discussion in current 113.00C, ``Malignant 
solid tumors,'' for the following reasons:
     We are proposing to delete current listing 113.03, the 
general listing for malignant solid tumors. We provide the reason for 
this deletion in the discussion of 113.01.
     We are proposing to incorporate the guidance about the 
evaluation of thyroid tumors in the second sentence of current 113.00C 
in proposed listing 113.09.
     We are proposing to move the criteria for evaluating 
malignant brain tumors to this body system. Therefore, we would no 
longer need the reference to current listing 111.05.
    As we explained in the discussion of 107.00, we have, with the 
exception of minor changes to refer to children, repeated much of the 
preface of proposed 13.00 in the preface to proposed 113.00. Because we 
have already described these provisions under the explanation of 
proposed 13.00, the following discussions describe only those 
provisions that are unique to the childhood rules or that require 
further explanation.

Proposed 113.00B--What Do We Consider When We Evaluate Malignant 
Neoplastic Diseases Under These Listings?

    In this section, which is the same as proposed 13.00B, we replace 
the guidance in current 113.00A1.

Proposed 113.00D--What Evidence Do We Need?

    In this section, we replace and expand current 113.00B. This 
section is the same as proposed 13.00D, except that we have deleted the 
guidance about what we need when the primary site cannot be identified. 
We are not proposing a childhood listing to correspond to proposed 
listing 13.27, primary site unknown, because the inability to determine 
the primary site is an extremely rare occurrence in childhood 
malignancies. In these rare situations, we would use proposed listing 
13.27.

Proposed 113.00E--When Do We Need Longitudinal Evidence?

    This section is similar to proposed 13.00E. We are adding a general 
description of most malignant childhood tumors.

Proposed 113.00F--How Do We Evaluate Impairments That Do Not Meet One 
of the Malignant Neoplastic Diseases Listings?

    In this section, we repeat the guidance in proposed 13.00F but use 
the definition of disability for children who claim SSI payments.

Proposed 113.00G--How Do We Consider the Effects of Therapy?

    This section would replace current 113.00A2 and the last paragraph 
of 113.00A. We repeat the guidance in proposed 13.00G but use the 
definition of disability for children who claim SSI payments.

Proposed 113.00H--How Long Do We Consider the Child Disabled?

    This section would replace current 113.00D, ``Duration of 
disability,'' which refers to the periods of disability included in 
current listings 113.02 and 113.03. Although we do not cite specific 
listings in the proposed rule, we indicate that some listings specify 
that the impairment should be considered disabling until a particular 
point in time. In proposed 113.00H(2) we also state that when the 
listing does not contain such a specification, we will find a child 
whose impairment meets or medically equals the listings in this body 
system to be under a disability until at least 3 years after onset of 
complete remission. We propose this to ensure consistency between the 
adult and childhood rules.

Proposed 113.00K--How Do We Evaluate Specific Malignant Neoplastic 
Diseases?

    In this section, we incorporate the discussion in current 107.00C, 
``Acute leukemia,'' and provide guidance for other childhood 
malignancies. Except for minor changes to refer to children, proposed 
113.00K(3), ``Brain Tumors,'' is the same as the proposed 13.00K(6). 
The following discussions of lymphoma and leukemia reflect criteria we 
are proposing specifically for the evaluation of these malignancies in 
children.

Proposed 113.00K(1)--Lymphoma

    In this section we indicate that proposed listing 113.05 should not 
be used for evaluating low grade or indolent lymphomas because they are 
rare in children. We would evaluate these lymphomas under proposed 
listing 13.05. We also provide a reminder to consider the duration and 
effects of long-term protocols used to treat lymphoma.

Proposed 113.00K(2)--Leukemia

    Proposed 113.00K(2)(a), ``Acute leukemia,'' is the same as proposed 
13.00K(2)(a).
    Proposed 113.00K(2)(b), ``Chronic myelogenous leukemia (CML),'' is 
the same as proposed 13.00K(2)(b).
    In proposed 113.00K(2)(c), we provide a description of juvenile CML 
(JCML).
    Proposed 113.00K(2)(d) is similar to proposed 13.00K(2)(d). We did 
not repeat the reference to chronic lymphocytic leukemia in proposed 
13.00K(2)(c) because the disorder is extremely rare in children.

Proposed 113.00L--How Do We Evaluate Malignant Neoplastic Diseases 
Treated by Bone Marrow or Stem Cell Transplantation?

    In this section, we provide the same guidance as in proposed 
13.00L, but we do not refer to multiple myeloma because this impairment 
is not included in the proposed childhood listings.

How Are We Proposing To Change the Criteria in the Listings for 
Evaluating Malignant Neoplastic Diseases in Children?

113.01  Category of Impairments, Malignant Neoplastic Diseases

    We propose to delete current listing 113.03, ``Malignant solid 
tumors.'' Instead, we propose to provide separate listings for specific 
types of malignant solid tumors, such as soft tissue sarcoma (proposed 
listing 113.04), osteogenic sarcoma (proposed listing 113.11), and 
Wilms' tumor (proposed listing 113.21B). Due to advances in treatment, 
all malignant solid tumors in children do not necessarily result in 
listing-level severity. We would evaluate any malignant solid tumor not 
listed in these proposed rules on a case-by-case basis.
    We propose to renumber the childhood listings to maintain 
consistency with the adult rules for those malignancies that are 
addressed in both the adult and childhood rules. Because of this, the 
numbers of the

[[Page 59318]]

proposed childhood listings are not consecutive.

Proposed Listing 113.04--Soft Tissue Sarcoma (Including Ewing's 
Sarcoma, Primitive Neuroectodermal Tumor (PNET)

    In proposed listing 113.04A, we provide for a finding of disability 
for at least 12 months from the date of diagnosis for any localized 
tumor with or without metastases. With this provision, we would 
recognize the duration and debilitating effects of the treatment for 
this malignancy in children. In proposed listing 113.04B, we provide 
for a finding of disability when treatment has not been effective.

Proposed Listing 113.05--Lymphoma (Excluding T-cell Lymphoblastic 
Lymphoma--113.06)

    This listing corresponds to current listing 113.02, 
``Lymphoreticular malignant neoplasms.'' We propose to revise the 
listing to make it more consistent with proposed listing 13.05. In the 
discussion of the proposed adult listing above, we explain why we 
evaluate T-cell lymphocytic lymphoma under the criteria for leukemia.
    Proposed listing 113.05A would replace the criteria for Non-
Hodgkin's lymphoma in current listing 113.02B. Currently, there are 
several treatment regimens for this disease, and they vary in the 
amount of time needed to complete them. Many are of sufficiently short 
duration that the period of time the child has an impairment of 
listing-level severity is usually less than 12 months. Due to these 
advances in treatment, it is no longer appropriate to presume that the 
impairment will meet the statutory duration requirement. Instead, we 
propose to find a child disabled when treatment has not been effective.
    Proposed listing 113.05B would replace the criteria for Hodgkin's 
disease in current listing 113.02A. With the proposed criterion, we 
clarify what we mean by ``progressive disease not controlled by 
prescribed therapy'' in the current listing.
    In proposed listing 113.05C, we would add a criterion for bone 
marrow or stem cell transplantation.

Proposed 113.06--Leukemia

    This listing would replace current listing 107.11, ``Acute 
leukemia.'' In proposed listing 113.06A, ``Acute leukemia,'' we also 
include T-cell lymphoblastic lymphoma and JCML. JCML is an aggressive 
leukemia that responds poorly to therapy and is, therefore, more 
appropriately evaluated like an acute leukemia. The criteria in this 
listing are the same as in proposed listing 13.06A, and are explained 
in the discussion of that listing.
    In proposed listing 113.06B, which is the same as proposed listing 
13.06B, we would add criteria for evaluating CML, other than JCML.

Proposed Listing 113.09--Thyroid Gland

    This listing is the same as proposed adult listing 13.09 and would 
incorporate the guidance contained in current 113.00C. The listing 
criteria define when the malignancy is not controlled by prescribed 
therapy.

Proposed Listing 113.10--Retinoblastoma

    This proposed listing would revise current listing 113.05. We 
propose to delete current listing 113.05A, for bilateral involvement, 
because with advances in treatment this condition is often treated 
successfully. If treatment is not successful, we will evaluate the 
impairment under the other criteria in the proposed listing.
    Proposed listing 113.10A corresponds to current listing 113.05C. We 
propose no substantive changes.
    Proposed listing 113.10B corresponds to current listing 113.10D. We 
propose to revise the criteria to recognize that persistence after 
treatment, as well as recurrence, indicates a poor prognosis.
    Proposed listing 113.10C corresponds to current listing 113.05B. We 
propose to revise the description to make it clear that any metastatic 
disease is included under the listing.

Proposed 113.11--Osteogenic Sarcoma

    This listing is the same as proposed listing 13.11 except that we 
propose to limit the listing to ``osteogenic sarcoma'' instead of the 
broader category used in proposed listing 13.11 because other bone 
tumors are extremely rare in children.

Proposed 113.13--Nervous System

    This listing would revise the criteria for malignant brain tumors 
in current listing 111.05, ``Brain tumors.'' We propose to use the same 
criteria as proposed listing 13.13.

Proposed Listing 113.21--Kidneys and Adrenal Glands

    Proposed listing 113.21A would revise current listing 113.04, 
``Neuroblastoma,'' to reflect the present evaluation and treatment of 
this condition.
    Proposed listing 113.21B adds criteria for evaluating Wilms' tumor.

Proposed Listing 113.25--Testicles

    This listing is the same as proposed listing 13.25.

Proposed Listing 113.26--Germ Cell Tumors

    In this listing, we provide criteria for evaluating these 
malignancies.

Proposed Listing 113.28--Malignant Neoplastic Diseases Treated by Bone 
Marrow or Stem Cell Transplantation

    This listing is the same as proposed listing 13.28.

What Other Revisions Are We Proposing?

    Consistent with the proposed changes explained above, we also 
propose to:
     Revise current 11.00B to indicate that malignant brain 
tumors should be evaluated under the criteria in listing 13.13.
     Add 111.00E to provide the same guidance as proposed 
11.00B.
     Revise current listings 11.05 and 111.05 by removing the 
criteria for malignant brain tumors.
     Revise the cross-references in current listings 14.08G and 
114.08G to reflect the numbers in the proposed hematological disorders 
listings.

Clarity of These Proposed Rules

    Executive Order 12866 and the President's memorandum of June 1, 
1998 (63 FR 31885) require each agency to write all rules in plain 
language. In addition to your substantive comments on these proposed 
rules, we invite your comments on how to make these proposed rules 
easier to understand.
    For example:
     Have we organized the material to suit your needs?
     Are the requirements in the rules clearly stated?
     Do the rules contain technical language or jargon that 
isn't clear?
     Would a different format (grouping and order of sections, 
use of headings, paragraphing) make the rules easier to understand?
     Would more (but shorter) sections be better?
     Could we improve clarity by adding tables, lists, or 
diagrams?
     What else could we do to make the rules easier to 
understand?

Regulatory Procedures

Executive Order 12866

    The Office of Management and Budget (OMB) has reviewed these 
proposed rules in accordance with Executive Order 12866.

[[Page 59319]]

Regulatory Flexibility Act

    We certify that these proposed rules would not have a significant 
economic impact on a substantial number of small entities because they 
would affect only individuals. Thus, a regulatory flexibility analysis 
as provided in the Regulatory Flexibility Act, as amended, is not 
required.

Paperwork Reduction Act

    These proposed rules contain reporting requirements at 7.00A, 
7.00B, 7.00D, 7.00E, 7.00G, 7.02, 7.03, 7.04, 7.05, 13.00B, 13.00D, 
13.00E, 13.00G, 13.00K, 107.00A, 107.00B, 107.00D, 107.00E, 107.00G, 
107.02, 107.03, 107.05, 113.00B, 113.00D, 113.00E, 113.00G, and 
113.00K. The public reporting burden is accounted for in the 
Information Collection Requests for the various forms that the public 
uses to submit the information to SSA. Consequently, a 1-hour 
placeholder burden is being assigned to the specific reporting 
requirement(s) contained in these rules. We are seeking clearance of 
the burdens referenced in these rules because they were not considered 
during the clearance of the forms. An Information Collection Request 
has been submitted to OMB. We are soliciting comments on the burden 
estimate; the need for the information; its practical utility; ways to 
enhance its quality, utility and clarity; and on ways to minimize the 
burden on respondents, including the use of automated collection 
techniques or other forms of information technology. Comments should be 
submitted to the Social Security Administration at the following 
address:

Social Security Administration, Attn: SSA Reports Clearance Officer, 
Rm. 1-A-20, Operations Building, 6401 Security Boulevard, Baltimore, MD 
21235-6401

Comments can be received for between 30 and 60 days after publication 
of this notice and will be most useful if received by SSA within 30 
days of publication.

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

List of Subjects in 20 CFR Part 404

    Administrative practice and procedure, Blind, Disability benefits, 
Old-Age, Survivors, and Disability Insurance, Reporting and 
recordkeeping requirements, Social Security.

    Dated: November 8, 2001.
Larry G. Massanari,
Acting Commissioner of Social Security.
    For the reasons set forth in the preamble, we propose to amend 
chapter III of title 20 of the Code of Federal Regulations as set forth 
below:

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

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

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

Appendix 1 to Subpart P of Part 404--[Amended]

    2. Appendix 1 to subpart P of part 404 is amended as follows:
    a. Items 8 and 14 of the introductory text before part A are 
revised.
    b. The Table of Contents for part A is amended by revising the body 
system names for sections 7.00 and 13.00.
    c. Section 7.00 of part A is revised.
    d. Paragraph B of the introductory text of section 11.00, 
Neurological, of part A is revised.
    e. Listing 11.05 of part A is revised.
    f. Section 13.00 of part A is revised.
    g. Listing 14.08G of part A is revised.
    h. The Table of Contents for part B is amended by revising the body 
system names for sections 107.00 and 113.00.
    i. Section 107.00 of part B is revised.
    j. Section 111.00E is added to part B.
    k. Listing 111.05 of part B is revised.
    l. Section 113.00 of part B is revised.
    m. Listing 114.08G of part B is revised.
    The revised text is set forth as follows:

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

* * * * *
    8. Hematological disorders (7.00 and 107.00): (insert date 5 
years from the effective date of the final rules).
* * * * *
    14. Malignant Neoplastic Diseases (13.00 and 113.00): (insert 
date 5 years from the effective date of the final rules).
* * * * *

Part A

* * * * *

7.00  Hematological Disorders

* * * * *

13.00  Malignant Neoplastic Diseases

* * * * *

7.00  Hematological Disorders

A. What do we Consider when we Evaluate Hematological Disorders 
Under These Listings?

     We consider factors such as the:
    (1) Type of disorder.
    (2) Response to therapy.
    (3) Side effects of therapy.
    (4) Effects of any post-therapeutic residuals.
    (5) Degree of limitation the disorder imposes on the individual.
    (6) Expected duration.

B. What Documentation do we Need?

    (1) We 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. The 
record should include laboratory findings, such as hemoglobin values 
or platelet counts, obtained on more than one examination over the 
3-month period.
    (2) Any longitudinal clinical record should also include a 
description of the therapy prescribed by the treating source and the 
individual's response to treatment, because medical management may 
improve functional status. The longitudinal record should provide 
information regarding functional recovery, if any.
    (3) Even when an individual does not receive ongoing treatment 
or have an ongoing relationship with a medical source, it is 
important to obtain evidence from relevant sources over a sufficient 
period. Such evidence may provide information about the:
    (a) Ongoing medical severity of the impairment.
    (b) Frequency, severity, and duration of symptoms.
    (c) Level of the individual's functioning.

C. How Do We Evaluate Impairments That Do Not Meet one of the 
Hematological Disorders Listings?

    (1) These listings are only examples of common hematological 
disorders that we consider severe enough to prevent an individual 
from doing any gainful activity. If the individual's impairment(s) 
does not meet the criteria of any of these listings, we must also 
consider whether the individual has an impairment(s) that satisfies 
the criteria of a listing in another body system.
    (2) If an individual has a medically determinable impairment(s) 
that does not meet a listing, we will determine whether the 
impairment(s) medically equals the listings. (See Secs. 404.1526 and 
416.926.) An individual who has an impairment(s) that does not meet 
or medically equal the listings may or may not have the residual 
functional capacity to engage in substantial gainful activity. For 
such an individual, we proceed to the fourth, and if necessary, the 
fifth steps of the sequential evaluation process in Secs. 404.1520 
and 416.920. When we decide whether an adult continues to be 
disabled, we use the rules in Secs. 404.1594 and 416.994.

D. How Do We Assess the Effectiveness of Treatment?

    (1) We assess the effectiveness of treatment by seeing if there 
is improvement in the

[[Page 59320]]

signs, symptoms, and laboratory findings of the disorder, and if 
there are side effects that may result in functional limitations in 
the individual. Because the response to treatment and adverse 
consequences of treatment may vary widely, we consider each case on 
an individual basis.
    (2) We will request a specific description of the:
    (a) Drugs or treatment given.
    (b) Dosage, method, and frequency of administration.
    (3) We will also request a description of the complications or 
adverse effects of treatment, such as the following:
    (a) Continuing gastrointestinal symptoms.
    (b) Persistent weakness.
    (c) Neurological complications.
    (d) Cardiovascular complications.
    (e) Reactive mental disorders.
    (4) Because the effects of treatment may be temporary, enough 
time must pass to allow us to evaluate the impact of treatment.

E. How Do We Evaluate Episodic Hematological Disorders?

    Some hematological disorders listings are met when a specified 
number of events have occurred within a specified time period, such 
as 3 events within a consecutive 12-month period. Events include 
pain crises, hospitalizations, treatment with parenteral 
antimicrobial medication, bleeding episodes, and thromboses. When we 
use such criteria, the period specified in the listing (either 6 
months or 12 months) must occur within the period we are considering 
in connection with an application or continuing disability review. 
In every listing in which we require more than one event, there must 
be at least 1 month between the events, in order to ensure that we 
are evaluating separate episodes.

F. What Do These Terms in the Listings Mean?

    (1) Persistent: The longitudinal clinical record shows that, 
with few exceptions, the hemoglobin level has been at or below, or 
is expected to be at or below, the level specified in the listing 
for a continuous period of at least 12 months.
    (2) Repeated, repeatedly: The longitudinal clinical record shows 
that the platelet count, neutrophil count, or hemoglobin level, as 
appropriate, satisfies the criteria in the listing most of the time, 
and that pattern has lasted or is expected to last for a continuous 
period of at least 12 months.

G. How Do We Evaluate Specific Hematological Disorders?

    (1) Anemia. Anemia refers to decreased oxygen-carrying capacity 
of the blood and is usually measured as a decrease in hemoglobin 
concentration. A gradual reduction in hemoglobin, even to very low 
levels, is often well tolerated in individuals with normal 
cardiovascular and pulmonary systems. We generally evaluate the 
effects of chronic anemia under the criteria for the underlying 
disorder or for the affected body system. However, we include 
listings for sickle cell disease or one of its variants and aplastic 
anemia because of their specific manifestations.
    (2) Sickle cell disease or one of its variants. (a) Sickle cell 
disease is a chronic hemolytic anemia in which the abnormal sickle 
cell hemoglobin may be either homozygous or in combination with 
thalassemia or with another abnormal hemoglobin. The diagnosis of 
sickle cell disease or one of its variants should be based on 
appropriate hematological evidence, such as hemoglobin 
electrophoresis. We accept medical evidence that is persuasive that 
a positive diagnosis of sickle cell disease or one of its variants 
has been confirmed by appropriate laboratory testing at some time 
prior to evaluation in lieu of a copy of the actual laboratory 
report.
    (b) We will document the intensity, frequency, duration, and 
response to treatment of vaso-occlusive or aplastic episodes.
    (c) Parenteral medication as required under 7.02A does not 
include hydration.
    (3) Disorders of hemostasis. (a) ``Disorders of hemostasis'' 
refers to abnormalities in the ability of the blood to clot. These 
disorders must be documented by appropriate laboratory evidence, 
including platelet counts and evaluation of plasma clotting factors 
such as Factor VIII or Factor V Leiden.
    (b) We will document the frequency, severity, and treatment of 
bleeding episodes or thromboses. Prophylactic therapy, such as 
factor concentrates or antithrombotic agents, does not, by itself, 
indicate any specific degree of severity.
    (c) We must consider complications such as development of 
inhibitors against clotting factors, intrusiveness of treatment, and 
limitation of function. We must also consider effects on other body 
systems. For example, we will evaluate hemarthrosis with joint 
deformity under 1.02, and intracranial bleeding under 11.04.
    (4) Hematological malignancies. With the exception of lymphoma 
associated with human immunodeficiency virus (HIV) infection, we use 
the guidance in 13.00K(3) (Macroglobulinemia or heavy chain disease) 
or the criteria in 13.05 (Lymphoma), 13.06 (Leukemia), 13.07 
(Multiple myeloma), or 13.28 (Malignant neoplastic diseases treated 
by bone marrow or stem cell transplantation) to evaluate 
hematological malignancies. We evaluate lymphoma associated with HIV 
infection under the criteria in 14.08E.
    (5) Chronic iron overload. Chronic iron overload resulting from 
hereditary hemochromatosis, a genetic disorder of excessive 
absorption of dietary iron, is usually treated by iron removal 
through repeated phlebotomy. Chronic iron overload resulting from 
repeated red blood cell transfusion (transfusion hemosiderosis) is 
generally treated with iron chelation therapy. We evaluate residuals 
of this impairment under the criteria for the affected body system, 
such as cardiovascular or digestive.

H. How Do We Evaluate Non-Malignant Hematological Disorders Treated 
by Allogeneic Bone Marrow or Stem Cell Transplantation?

    Allogeneic bone marrow or stem cell transplantation 
(transplantation from an unrelated donor or a related donor other 
than an identical twin) is performed for a variety of non-malignant 
hematological diseases, such as sickle cell disease and aplastic 
anemia. We will evaluate any non-malignant hematological disorder 
that is treated with allogeneic bone marrow or stem cell 
transplantation under 7.06, regardless of whether there is another 
listing that addresses that impairment. Under 7.06, we consider an 
individual disabled until at least 12 months from the date of 
transplantation. Thereafter, for purposes of evaluating disability, 
we consider any residual impairment(s), such as complications 
arising from:
    (1) Graft-versus-host (GVH) disease.
    (2) Immunosuppressive therapy, such as frequent infections.
    (3) Significant deterioration of other organ systems.
    7.01  Category of Impairments, Hematological Disorders
    7.02  Sickle cell disease or one of its variants, with one of 
the following:
    A. Documented painful (vaso-occlusive) crises requiring 
parenteral medication, occurring at least 3 times in a consecutive 
6-month period (see 7.00E).
        OR
    B. Hospitalization (for 24 hours or more) for sickle cell 
related diseases, occurring at least 3 times in a consecutive 12-
month period (see 7.00E).
        OR
    C. Chronic anemia manifested by persistent hemoglobin of 7.0 gm/
dl or less despite prescribed therapy (see 7.00F).
    7.03 Disorders of hemostasis.
    A. Chronic thrombocytopenia (due to any cause), with either 1 or 
2:
    1. Platelet counts repeatedly below 10,000/mm3 despite 
prescribed therapy (see 7.00F).
    2. Platelet counts repeatedly below 20,000/mm3 and spontaneous 
bleeding despite prescribed therapy, requiring red cell or platelet 
transfusion at least 3 times in a consecutive 12-month period (see 
7.00E, 7.00F). Consider under a disability for 12 months from the 
date of the last transfusion. Thereafter, evaluate any residual 
impairment(s) under the criteria for the affected body system.
        OR
    B. Hemophilia with spontaneous bleeding despite prophylactic 
factor replacement, occurring at least 3 times in a consecutive 12-
month period (see 7.00E).
        OR
    C. Other hypocoagulable states (such as von Willebrand's disease 
or thrombasthenia) with spontaneous bleeding requiring 
hospitalization (for 24 hours or more), occurring at least 3 times 
in a consecutive 12-month period (see 7.00E).
        OR
    D. Hypercoagulable states (deficiency of anti-coagulant proteins 
such as protein C, protein S, and antithrombin, or the presence of 
abnormal proteins such as Factor V Leiden) with documented 
thromboses occurring at least 3 times in a consecutive 12-month 
period (see 7.00E).
    7.04 Aplastic anemia, myeloproliferative disorders (such as 
polycythemia vera or myelofibrosis), or myelodysplastic syndrome 
with:
    A. Chronic anemia manifested by repeated hemoglobin of 7.0 gm/dl 
or less despite prescribed therapy (see 7.00F).

[[Page 59321]]

        OR
    B. Documented treatment with parenteral antimicrobial medication 
occurring at least 3 times in a consecutive 12-month period (see 
7.00E).
    7.05 Chronic granulocytopenia (due to any cause), with both A 
and B:
    A. Absolute neutrophil counts repeatedly below 500/mm3 (see 
7.00F).
        AND
    B. Documented treatment with parenteral antimicrobial medication 
occurring at least 3 times in a consecutive 12-month period (see 
7.00E).
    7.06 Non-malignant hematological diseases treated by allogeneic 
bone marrow or stem cell transplantation (see 7.00H). Consider under 
a disability until at least 12 months from the date of 
transplantation. Thereafter, evaluate any residual impairment(s) 
under the criteria for the affected body system.
* * * * *

11.00  NEUROLOGICAL

* * * * *
    B. Brain tumors. We evaluate malignant brain tumors under the 
criteria in 13.13. For benign brain tumors, we determine the 
severity and duration of the impairment on the basis of symptoms, 
signs, and laboratory findings (11.05).
* * * * *
    11.05 Benign brain tumors. Evaluate under 11.02, 11.03, 11.04A 
or B, or 12.02.
* * * * *

13.00  MALIGNANT NEOPLASTIC DISEASES

    A. What impairments do these listings cover? We use these 
listings to evaluate all malignant neoplasms except certain 
neoplasms associated with human immunodeficiency virus (HIV) 
infection. We use the criteria in 14.08E to evaluate carcinoma of 
the cervix, Kaposi's sarcoma, lymphoma, and squamous cell carcinoma 
of the anus in individuals with HIV infection.
    B. What do we consider when we evaluate malignant neoplastic 
diseases under these listings? We consider factors such as the:
    (1) Origin of the malignancy.
    (2) Extent of involvement.
    (3) Duration, frequency, and response to antineoplastic therapy. 
Antineoplastic therapy means surgery, irradiation, chemotherapy, 
hormones, immunotherapy, or bone marrow or stem cell 
transplantation. When we refer to surgery as an antineoplastic 
treatment, we mean surgical excision for treatment, not for 
diagnostic purposes.
    (4) Effects of any post-therapeutic residuals.
    C. How do we apply these listings? Except for metastatic 
carcinoma to the brain or spinal cord (13.13C), we apply the 
criteria in a specific listing to a malignancy originating from that 
specific site.
    D. What evidence do we need? (1) We need medical evidence that 
specifies the type, extent, and site of the primary, recurrent, or 
metastatic lesion. When the primary site cannot be identified, we 
will use evidence documenting the site(s) of metastasis to evaluate 
the impairment under 13.27.
    (2) For operative procedures, including a biopsy or a needle 
aspiration, we need a copy of both the:
    (a) Operative note.
    (b) Pathology report.
    (3) When we cannot get these documents, we will accept the 
summary of hospitalization(s) or other medical reports. This 
evidence should include details of the findings at surgery and, 
whenever appropriate, the pathological findings.
    (4) In some situations we may also need evidence about 
recurrence, persistence, or progression of the malignancy, the 
response to therapy, and any significant residuals. (See 13.00G.)
    E. When do we need longitudinal evidence? (1) Tumors with 
distant metastases. We generally do not need longitudinal evidence 
for tumors that have metastasized beyond the regional lymph nodes 
because these tumors usually meet the requirements of a listing. 
Exceptions are for tumors with distant metastases that are expected 
to respond to antineoplastic therapy. For these exceptions, we 
usually need a longitudinal record of 3 months after therapy starts 
to determine whether the intended effect of therapy has been 
achieved and is likely to persist.
    (2) Other malignancies. When there are no distant metastases, 
many of the listings require that we consider the individual's 
response to initial antineoplastic therapy; that is, the initial 
planned treatment regimen. This therapy may consist of a single 
modality or a combination of modalities (multimodal) given in close 
proximity as a unified whole, and is usually planned before any 
treatment(s) is initiated. Examples of multimodal therapy include:
    (a) Surgery followed by chemotherapy or radiation.
    (b) Chemotherapy followed by surgery.
    (c) Chemotherapy and concurrent radiation.
    (3) Types of treatment. Whenever the initial planned therapy is 
a single modality, enough time must pass to allow a determination 
about whether the therapy will achieve its intended effect. If the 
treatment fails, it will often happen within 6 months after it 
starts, and there will often be a change in the treatment regimen. 
Whenever the initial planned therapy is multimodal, a determination 
about the effectiveness of the therapy usually cannot be made until 
the effects of all the planned modalities can be determined. In some 
cases, we may need to defer adjudication until the effectiveness of 
therapy can be assessed. However, we do not need to defer 
adjudication to determine whether the therapy will achieve its 
intended effect if we can make a fully favorable determination or 
decision based on the length and effects of therapy, or the 
residuals of the malignancy or therapy (see 13.00G).
    F. How do we evaluate impairments that do not meet one of the 
Malignant Neoplastic Diseases listings?
    (1) These listings are only examples of malignant neoplastic 
diseases that we consider severe enough to prevent an individual 
from engaging in any gainful activity. If the individual's 
impairment(s) does not meet the criteria of any of these listings, 
we must also consider whether the individual has an impairment(s) 
that satisfies the criteria of a listing in another body system.
    (2) If an individual has a medically determinable impairment(s) 
that does not meet a listing, we will determine whether the 
impairment(s) medically equals the listings. (See Secs. 404.1526 and 
416.926.) An individual who has an impairment(s) that does not meet 
or medically equal the listings may or may not have the residual 
functional capacity to engage in substantial gainful activity. For 
such an individual, we proceed to the fourth, and if necessary, the 
fifth steps of the sequential evaluation process in Secs. 404.1520 
and 416.920. When we decide whether an adult continues to be 
disabled, we use the rules in Secs. 404.1594 and 416.994.
    G. How do we consider the effects of therapy? (1) How we 
consider the effects of therapy under the listings. In many cases, 
malignancies meet listing criteria only if the therapy does not 
achieve the intended effect: the malignancy persists, progresses, or 
recurs despite treatment. However, as explained in the following 
paragraphs, we will not delay adjudication if we can make a fully 
favorable determination or decision based on the evidence in the 
case record.
    (2) Effects can vary widely. (a) Because the therapy and its 
toxicity may vary widely, we consider each case on an individual 
basis. We will request a specific description of the therapy, 
including these items:
    (i) Drugs given.
    (ii) Dosage.
    (iii) Frequency of drug administration.
    (iv) Plans for continued drug administration.
    (v) Extent of surgery.
    (vi) Schedule and fields of radiation therapy.
    (b) We will also request a description of the complications or 
adverse effects of therapy, such as the following:
    (i) Continuing gastrointestinal symptoms.
    (ii) Persistent weakness.
    (iii) Neurological complications.
    (iv) Cardiovascular complications.
    (v) Reactive mental disorders.
    (3) Effects of therapy may change. Because the severity of the 
adverse effects of antineoplastic therapy may change during 
treatment, enough time must pass to allow us to evaluate the 
therapy's effect. The residual effects of treatment are temporary in 
most instances. But, on occasion, the effects may be disabling for a 
consecutive period of at least 12 months.
    (4) When the initial antineoplastic therapy is effective. We 
evaluate any post-therapeutic residual impairment(s) not included in 
the Malignant Neoplastic Diseases listings under the criteria for 
the affected body system. We must consider any complications of 
therapy. When the residual impairment(s) does not meet or medically 
equal the listings, we must consider its affect on the individual's 
ability to do substantial gainful activity.
    H. How long do we consider the individual disabled?
    (1) In some listings, we specify that the impairment will be 
considered disabling until a particular point in time (for example, 
at least 18 months from the date of diagnosis). We may consider the 
impairment

[[Page 59322]]

to be disabling beyond this point when justified by the medical and 
other evidence.
    (2) When a listing does not contain such a specification, we 
will find an individual whose impairment(s) meets or medically 
equals a listing in this body system to be under a disability until 
at least 3 years after onset of complete remission. When the 
original tumor and any metastases have not been evident for at least 
3 years after complete remission, the impairment(s) no longer meets 
or equals the criteria under this body system.
    (3) Following the appropriate period, we will consider any 
residual impairment(s), including residuals of the malignancy or 
therapy (see 13.00G), in determining whether the individual is 
disabled.
    I. What do these terms in the listings mean? (1) Inoperable: 
Surgery was thought to be of no therapeutic value or the surgery 
could not be performed. Examples of when surgery cannot be performed 
include a tumor that is too large or that invades crucial 
structures, or an intolerance of anesthesia or surgery due to other 
medical conditions. This term does not include situations in which 
the tumor could have been surgically removed but another method of 
treatment was chosen; for example, an attempt at organ preservation. 
Determining whether a tumor is inoperable usually occurs before 
attempts to shrink the tumor with chemotherapy or radiation.
    (2) Unresectable: The operation was performed, but the malignant 
tumor was not removed. This term includes situations in which a 
tumor is incompletely resected or the surgical margins are positive.
    (3) Persistent: Failure to achieve a complete remission.
    (4) Progressive: The malignancy became more extensive after 
treatment.
    (5) Recurrent: A malignancy that had been in complete remission 
or entirely removed by surgery has returned.
    J. Can 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? Yes. We will consider factors 
such as:
    (1) The type of malignancy and its location.
    (2) The extent of involvement when the malignancy was first 
demonstrated.
    (3) Medically reported symptoms.
    K. How do we evaluate specific malignant neoplastic diseases? 
(1) Lymphoma. (a) Many indolent (non-aggressive) lymphomas, although 
they may produce intermittent symptoms and signs, are often 
controlled by well-tolerated treatment modalities. Therefore, we 
will defer adjudication of these cases for an appropriate period 
after initiation of therapy to determine whether the therapy will 
achieve its intended effect. (See 13.00E(3).) For an indolent 
lymphoma, the intended effect of therapy is usually stability of the 
disease process. When stability has been achieved, severity should 
be assessed on the basis of the extent of involvement of other organ 
systems and residuals from therapy.
    (b) A change in therapy is usually an indicator that the therapy 
is not achieving its intended effect. However, it is not an 
indicator if the change is based on the individual's (or the 
physician's) choice rather than a failure to achieve stability. If 
the therapy is changed due solely to choice, the requirements of 
listing 13.05A.2.a are not met.
    (c) We consider Hodgkin's disease that recurs more than 12 
months after completing initial antineoplastic therapy to be a new 
disease rather than a recurrence.
    (2) Leukemia. (a) Acute leukemia. The initial diagnosis of acute 
leukemia, including the accelerated or blast phase of chronic 
myelogenous (granulocytic) leukemia, is based upon definitive bone 
marrow examination. Additional diagnostic information is based on 
chromosomal analysis, cytochemical and surface marker studies on the 
abnormal cells, or other methods consistent with the prevailing 
state of medical knowledge and clinical practice. Recurrent disease 
must be documented by peripheral blood, bone marrow, or 
cerebrospinal fluid examination. The initial and follow-up pathology 
reports should be included.
    (b) Chronic myelogenous leukemia (CML). The diagnosis of CML 
should be based upon documented granulocytosis, including immature 
forms such as differentiated or undifferentiated myelocytes and 
myeloblasts, and a chromosomal analysis that demonstrates the 
Philadelphia chromosome. In the absence of a chromosomal analysis, 
or if the Philadelphia chromosome is not present, the diagnosis may 
be made by other methods consistent with the prevailing state of 
medical knowledge and clinical practice.
    (c) Chronic lymphocytic leukemia. (i) The diagnosis of chronic 
lymphocytic leukemia (CLL) must be documented by evidence of a 
chronic lymphocytosis of at least 10,000/mm3 for 3 months 
or longer, or other acceptable diagnostic techniques consistent with 
the prevailing state of medical knowledge and clinical practice.
    (ii) We will evaluate the complications and residual impairments 
from CLL under the appropriate listing, such as 13.05A2, 7.03A, and 
7.05.
    (d) Elevated white cell counts. In cases of chronic leukemia 
(either myelogenous or lymphocytic), an elevated white cell count, 
in itself, is not ordinarily a factor in determining the severity of 
the impairment.
    (3) Macroglobulinemia or heavy chain disease. The diagnosis of 
these diseases must be confirmed by protein electrophoresis or 
immunoelectrophoresis. We evaluate the resulting impairment(s) under 
the criteria of 7.03 or 7.04, or of any other affected body system.
    (4) Bilateral primary breast cancer. We evaluate bilateral 
primary breast cancer (synchronous or metachronous) under 13.10A, 
which covers local primary disease, and not as a primary disease 
that has metastasized.
    (5) Carcinoma-in-situ. Carcinoma-in-situ, or preinvasive 
carcinoma, usually responds to treatment. When we use the term 
``carcinoma'' in these listings, it does not include carcinoma-in-
situ.
    (6) Brain tumors. We use the criteria in 13.13 to evaluate 
malignant brain tumors. We will evaluate any complications of 
malignant brain tumors, such as resultant neurological or 
psychological impairments, under the criteria for the affected body 
system. We evaluate benign brain tumors under 11.05.
    L. How do we evaluate malignant neoplastic diseases treated by 
bone marrow or stem cell transplantation? Bone marrow or stem cell 
transplantation is performed for a variety of malignant neoplastic 
diseases.
    (1) Acute leukemia (including T-cell lymphoblastic lymphoma) or 
accelerated or blast phase of CML. We consider an individual who 
undergoes bone marrow or stem cell transplantation for any of these 
disorders disabled until at least 24 months from the date of 
diagnosis or relapse, or at least 12 months from the date of 
transplantation, whichever is later.
    (2) Lymphoma, multiple myeloma, or chronic phase of CML. We 
consider an individual who undergoes bone marrow or stem cell 
transplantation for any of these disorders disabled until at least 
12 months from the date of transplantation.
    (3) Other malignancies. We will evaluate any other malignant 
neoplastic disease treated with bone marrow or stem cell 
transplantation under 13.28, regardless of whether there is another 
listing that addresses that impairment. The length of time we 
consider an individual whose impairment is evaluated under 13.28 to 
be disabled depends on whether the individual undergoes allogeneic 
or autologous transplantation.
    (a) Allogeneic bone marrow or stem cell transplantation. We will 
consider an individual who undergoes allogeneic transplantation 
(transplantation from an unrelated donor or a related donor other 
than an identical twin) disabled until at least 12 months from the 
date of transplantation.
    (b) Autologous bone marrow or stem cell transplantation. We will 
consider an individual who undergoes autologous transplantation 
(transplantation of the individual's own cells or cells from an 
identical twin (syngeneic transplantation)) disabled until at least 
12 months from the date of the first treatment under the treatment 
plan that includes transplantation. The first treatment usually 
refers to the initial therapy given to prepare the individual for 
transplantation.
    (4) Evaluating disability after the appropriate time period has 
elapsed. We consider any residual impairment(s), such as 
complications arising from:
    (a) Graft-versus-host (GVH) disease.
    (b) Immunosuppressant therapy, such as frequent infections.
    (c) Significant deterioration of other organ systems.

13.01  Category of Impairments, Malignant Neoplastic Diseases

    13.02  Soft tissue tumors of the head and neck (except salivary 
glands--13.06--and thyroid gland--13.07).
    A. Inoperable or unresectable.
        OR
    B. Persistent disease following initial multimodal 
antineoplastic therapy.
        OR
    C. Recurrent disease following initial antineoplastic therapy, 
except local vocal cord recurrence.
        OR

[[Page 59323]]

    D. With metastases beyond the regional lymph nodes.
        OR
    E. Epidermoid carcinoma occurring in the pyriform sinus.
    OR
    F. Soft tissue tumors of the head and neck not addressed in A-E, 
with multimodal antineoplastic therapy. Consider under a disability 
until at least 18 months from the date of diagnosis. Thereafter, 
evaluate any residual impairment(s) under the criteria for the 
affected body system.
    13.03  Skin.
    A. Sarcoma or carcinoma with metastases to or beyond the 
regional lymph nodes.
        OR
    B. Melanoma, with either 1 or 2:
    1. Recurrence after wide excision (except an additional primary 
melanoma at a different site, which is not considered to be 
recurrent disease).
    2. Palpable nodal metastases or metastases to adjacent skin 
(satellite lesions) or elsewhere.
    13.04  Soft tissue sarcoma.
    A. With regional or distant metastases.
        OR
    B. Persistent or recurrent following initial antineoplastic 
therapy.
    13.05  Lymphoma (including mycosis fungoides, but excluding T-
cell lymphoblastic lymphoma--13.06). (See 13.00K(1).)
    A. Non-Hodgkin's lymphoma, as described in 1 or 2:
    1. Intermediate or high-grade lymphoma persistent or recurrent 
following initial antineoplastic therapy.
    2. Low-grade or indolent lymphoma requiring initiation of more 
than 1 antineoplastic treatment regimen within a consecutive 12-
month period. Consider under a disability from the date of 
initiation of the treatment regimen that failed within 12 months.
        OR
    B. Hodgkin's disease with failure to achieve clinically complete 
remission, or recurrent disease within 12 months of completing 
initial antineoplastic therapy.
        OR
    C. With bone marrow or stem cell transplantation. Consider under 
a disability until at least 12 months from the date of 
transplantation. Thereafter, evaluate any residual impairment(s) 
under the criteria for the affected body system.
    13.06  Leukemia. (See 13.00K(2).)
    A. Acute leukemia (including T-cell lymphoblastic lymphoma). 
Consider 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. Thereafter, 
evaluate any residual impairment(s) under the criteria for the 
affected body system.
        OR
    B. Chronic myelogenous leukemia, as described in 1 or 2:
    1. Accelerated or blast phase. Consider 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. Thereafter, evaluate any 
residual impairment(s) under the criteria for the affected body 
system.
    2. Chronic phase, as described in a or b:
    a. Consider under a disability until at least 12 months from the 
date of bone marrow or stem cell transplantation. Thereafter, 
evaluate any residual impairment(s) under the criteria for the 
affected body system.
    b. Progressive disease following initial antineoplastic therapy.
    13.07  Multiple myeloma (confirmed by appropriate serum or urine 
protein electrophoresis and bone marrow findings), with 1 or 2:
    1. Failure to respond or progressive disease following initial 
antineoplastic therapy.
    2. Bone marrow or stem cell transplantation. Consider under a 
disability until at least 12 months from the date of 
transplantation. Thereafter, evaluate any residual impairment(s) 
under the criteria for the affected body system.
    13.08  Salivary glands--carcinoma or sarcoma with metastases 
beyond the regional nodes.
    13.09  Thyroid gland.
    A. Anaplastic (undifferentiated) carcinoma.
        OR
    B. Carcinoma with metastases beyond the regional lymph nodes 
progressive despite radioactive iodine therapy.
    13.10  Breast (except sarcoma--13.04). (See 13.00K(4).)
    A. Locally advanced carcinoma (inflammatory carcinoma, tumor of 
any size with direct extension to the chest wall or skin, tumor of 
any size with metastases to the ipsilateral internal mammary nodes).
        OR
    B. Carcinoma with distant metastases.
        OR
    C. Recurrent carcinoma, except local recurrence that remits with 
antineoplastic therapy.
    13.11  Skeletal system--carcinoma or sarcoma.
    A. Inoperable or unresectable.
        OR
    B. Recurrent tumor (except local recurrence) after initial 
antineoplastic therapy.
        OR
    C. With distant metastases.
        OR
    D. All other tumors originating in bone with multimodal 
antineoplastic therapy. Consider under a disability for 12 months 
from the date of diagnosis. Thereafter, evaluate any residual 
impairment(s) under the criteria for the affected body system.
    13.12  Maxilla, orbit, or infratemporal fossa.
    A. Sarcoma or carcinoma of any type with regional or distant 
metastases.
        OR
    B. Carcinoma of the antrum with extension into the orbit or 
ethmoid or sphenoid sinus, or with regional or distant metastases.
        OR
    C. Tumors with extension to the base of the skull, orbit, 
meninges, or sinuses.
    13.13  Nervous system. (See 13.00K(6).)
    A. Central nervous system neoplasms (brain and spinal cord), 
including:
    1. Highly malignant tumors, such as Grades III and IV 
astrocytoma, glioblastoma multiforme, ependymoblastoma, 
medulloblastoma or other primitive neuroectodermal tumors (PNETs) 
with documented metastases, diffuse intrinsic brain stem gliomas, or 
primary sarcomas.
    2. Any central nervous system neoplasm progressive or recurrent 
following initial antineoplastic therapy.
        OR
    B. Peripheral nerve or spinal root neoplasm, as described in 1 
or 2:
    1. Metastatic.
    2. Progressive or recurrent following initial antineoplastic 
therapy.
        OR
    C. Metastatic carcinoma to brain or spinal cord (includes 
epidural metastases).
    13.14 Lungs.
    A. Non-small-cell carcinoma--inoperable, unresectable, 
recurrent, or metastatic disease to or beyond the mediastinal or 
subcarinal lymph nodes.
        OR
    B. Small-cell (oat cell) carcinoma.
    13.15 Pleura or mediastinum.
    A. Malignant mesothelioma of pleura.
        OR
    B. Tumors of the mediastinum, as described in 1 or 2:
    1. Metastatic.
    2. Persistent or recurrent following initial antineoplastic 
therapy.
    13.16 Esophagus or stomach.
    A. Carcinoma or sarcoma of the esophagus.
        OR
    B. Carcinoma or sarcoma of the stomach, as described in 1 or 2:
    1. Inoperable, unresectable, extending to surrounding 
structures, or recurrent.
    2. With metastases to or beyond the regional lymph nodes.
    13.17 Small intestine--carcinoma, sarcoma, or carcinoid.
    A. Inoperable, unresectable, or recurrent.
        OR
    B. With metastases beyond the regional lymph nodes.
    13.18 Large intestine (from ileocecal valve to and including 
anal canal).
    A. Adenocarcinoma that is inoperable, unresectable, or 
recurrent.
        OR
    B. Squamous cell carcinoma of the anus, recurrent after surgery.
        OR
    C. With metastases beyond the regional lymph nodes.
    13.19 Liver or gallbladder--tumors of the liver, gallbladder, or 
bile ducts.
    13.20 Pancreas.
    A. Carcinoma (except islet cell carcinoma).
        OR
    B. Islet cell carcinoma that is inoperable or unresectable and 
physiologically active.
    13.21 Kidneys, adrenal glands, or ureters--carcinoma.
    A. Inoperable, unresectable, or recurrent.
        OR
    B. With metastases to the regional lymph nodes or beyond.
    13.22 Urinary bladder--carcinoma, with:
    A. Infiltration beyond the bladder wall.
        OR
    B. Recurrent after total cystectomy.
        OR
    C. Inoperable or unresectable.

[[Page 59324]]

        OR
    D. Metastases to or beyond the regional lymph nodes.
    13.23 Cancers of the female genital tract--carcinoma or sarcoma.
    A. Uterus (corpus), as described in 1, 2, or 3:
    1. Invading adjoining organs.
    2. With metastases to or beyond the regional lymph nodes.
    3. Persistent or recurrent following initial antineoplastic 
therapy.
        OR
    B. Uterine cervix, as described in 1 or 2:
    1. Extending to the pelvic wall, lower portion of the vagina, or 
adjacent or distant organs.
    2. Persistent or recurrent following initial antineoplastic 
therapy.
        OR
    C. Vulva, as described in 1, 2, or 3:
    1. Invading adjoining organs.
    2. With metastases to or beyond the regional lymph nodes.
    3. Persistent or recurrent following initial antineoplastic 
therapy.
        OR
    D. Fallopian tube, as described in 1 or 2:
    1. Extending to the serosa or beyond.
    2. Persistent or recurrent following initial antineoplastic 
therapy.
        OR
    E. Ovaries, as described in 1 or 2:
    1. All tumors except germ cell tumors, with at least one of the 
following:
    a. Tumor extension beyond the pelvis; for example, tumor 
implants on peritoneal, omental, or bowel surfaces.
    b. Metastases to or beyond the regional lymph nodes.
    c. Ruptured ovarian capsule, tumor on the serosal surface of the 
ovary, ascites with malignant cells, or positive peritoneal 
washings.
    d. Recurrence following initial antineoplastic therapy.
    2. Germ cell tumors--progressive or recurrent following initial 
antineoplastic therapy.
    13.24 Prostate gland--carcinoma.
    A. Progressive or recurrent despite initial hormonal 
intervention.
        OR
    B. With visceral metastases.
    13.25 Testicles--tumor with metastatic disease progressive or 
recurrent following initial chemotherapy.
    13.26 Penis--carcinoma with metastases to or beyond the regional 
lymph nodes.
    13.27 Primary site unknown after appropriate search for 
primary--metastatic carcinoma or sarcoma, except for solitary 
squamous cell carcinoma in the neck.
    13.28 Malignant neoplastic diseases treated by bone marrow or 
stem cell transplantation. (See 13.00L.)
    A. Allogeneic transplantation. Consider under a disability until 
at least 12 months from the date of transplantation. Thereafter, 
evaluate any residual impairment(s) under the criteria for the 
affected body system.
        OR
    B. Autologous transplantation. Consider under a disability until 
at least 12 months from the date of the first treatment under the 
treatment plan that includes transplantation. Thereafter, evaluate 
any residual impairment(s) under the criteria for the affected body 
system.
* * * * *

14.08  Human Immunodeficiency Virus (HIV) Infection

* * * * *
    G. Hematologic abnormalities:
    1. Anemia, as described under the criteria in 7.02C; or
    2. Granulocytopenia, as described under the criteria in 7.05; or
    3. Thromobocytopenia, as described under the criteria in 7.03A.
* * * * *

Part B

* * * * *

107.00  Hematological Disorders

* * * * *

113.00  Malignant Neoplastic Diseases

* * * * *

107.00  Hematological Disorders

    A. What do we consider when we evaluate hematological disorders 
under these listings? We consider factors such as the:
    (1) Type of disorder.
    (2) Response to therapy.
    (3) Side effects of therapy.
    (4) Effects of any post-therapeutic residuals.
    (5) Degree of limitation the disorder imposes on the child.
    (6) Expected duration.
    B. What documentation do we need?
    (1) We 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. The 
record should include laboratory findings, such as hemoglobin values 
or platelet counts, obtained on more than one examination over the 
3-month period.
    (2) Any longitudinal clinical record should also include a 
description of the therapy prescribed by the treating source and the 
child's response to treatment, because medical management may 
improve functional status. The longitudinal record should provide 
information regarding functional recovery, if any.
    (3) Even when a child does not receive ongoing treatment or have 
an ongoing relationship with a medical source, it is important to 
obtain evidence from relevant sources over a sufficient period. Such 
evidence may provide information about the:
    (a) Ongoing medical severity of the impairment.
    (b) Frequency, severity, and duration of symptoms.
    (c) Level of the child's functioning.
    C. How do we evaluate impairments that do not meet one of the 
Hematological Disorders listings?
    (1) These listings are only examples of common hematological 
disorders that we consider severe enough to result in marked and 
severe functional limitations. If the child's impairment(s) does not 
meet the criteria of any of these listings, we must also consider 
whether the child has an impairment(s) that satisfies the criteria 
of a listing in another body system.
    (2) If a child has a medically determinable impairment(s) that 
does not meet a listing, we will determine whether the impairment(s) 
medically equals the listings, or, in the case of a claim for SSI 
payments, functionally equals the listings. (See Secs. 404.1526, 
416.926, and 416.926a.) When we decide whether a child receiving SSI 
payments continues to be disabled, we use the rules in 
Sec. 416.994a.
    D. How do we assess the effectiveness of treatment? (1) We 
assess the effectiveness of treatment by seeing if there is 
improvement in the signs, symptoms, and laboratory findings of the 
disorder, and if there are side effects that may result in 
functional limitations in the child. Because the response to 
treatment and adverse consequences of treatment may vary widely, we 
consider each case on an individual basis.
    (2) We will request a specific description of the:
    (a) Drugs or treatment given.
    (b) Dosage, method, and frequency of administration.
    (3) We will also request a description of the complications or 
adverse effects of treatment, such as the following:
    (a) Continuing gastrointestinal symptoms.
    (b) Persistent weakness.
    (c) Neurological complications.
    (d) Cardiovascular complications.
    (e) Reactive mental disorders.
    (4) Because the effects of treatment may be temporary, enough 
time must pass to allow us to evaluate the impact of treatment.
    E. How do we evaluate episodic hematological disorders? Some 
hematological disorders listings are met when a specified number of 
events have occurred within a specified time period, such as 3 
events within a consecutive 12-month period. Events include pain 
crises, hospitalizations, treatment with parenteral antimicrobial 
medication, bleeding episodes, and thromboses. When we use such 
criteria, the period specified in the listing (either 6 months or 12 
months) must occur within the period we are considering in 
connection with an application or continuing disability review. In 
every listing in which we require more than one event, there must be 
at least 1 month between the events, in order to ensure that we are 
evaluating separate episodes.
    F. What do these terms in the listings mean? (1) Persistent: The 
longitudinal clinical record shows that, with few exceptions, the 
hemoglobin level has been at or below, or is expected to be at or 
below, the level specified in the listing for a continuous period of 
at least 12 months.
    (2) Repeated, repeatedly: The longitudinal clinical record shows 
that the platelet count, neutrophil count, or hemoglobin level, as 
appropriate, satisfies the criteria in the listing most of the time, 
and that pattern has lasted or is expected to last for a continuous 
period of at least 12 months.
    G. How do we evaluate specific hematological disorders? (1) 
Anemia. Anemia refers to decreased oxygen-carrying capacity of the 
blood and is usually measured as a decrease in hemoglobin

[[Page 59325]]

concentration. A gradual reduction in hemoglobin, even to very low 
levels, is often well tolerated in infants and children with normal 
cardiovascular and pulmonary systems. We generally evaluate the 
effects of chronic anemia under the criteria for the underlying 
disorder or for the affected body system. However, we include 
listings for hemolytic anemias and aplastic anemia because of their 
specific manifestations.
    (2) Hemolytic anemias. (a) Sickle cell disease or one of its 
variants. (i) Sickle cell disease is a chronic hemolytic anemia in 
which the abnormal sickle cell hemoglobin may be either homozygous 
or in combination with thalassemia or with another abnormal 
hemoglobin. The diagnosis of sickle cell disease or one of its 
variants should be based on appropriate hematological evidence, such 
as hemoglobin electrophoresis. Frequently, this information is a 
part of the newborn screening data. We accept medical evidence that 
is persuasive that a positive diagnosis of sickle cell disease or 
one of its variants has been confirmed by appropriate laboratory 
testing at some time prior to evaluation in lieu of a copy of the 
actual laboratory report.
    (ii) We will document the intensity, frequency, duration, and 
response to treatment of vaso-occlusive or aplastic episodes.
    (iii) Parenteral medication as required under 107.02A1 does not 
include hydration.
    (iv) To satisfy the criterion in 107.02A2, hospitalizations for 
children with sickle cell disease must be due to complications of 
the disease. We list the most common complications of sickle cell 
disease requiring hospitalization in the listing. Other 
complications of sickle cell disease requiring hospitalization may 
be of equal clinical significance to, and thus be medically equal to 
the ones listed. When we make a determination whether a complication 
is of equal clinical significance, we will make reasonable efforts 
to ensure that a qualified pediatrician or other individual who 
specializes in childhood hematological disorders evaluates the case.
    (b) Thalassemia. Thalassemia is a type of hemolytic disorder in 
which the rate of erythropoeisis (red cell formation in the bone 
marrow) is inappropriate for the degree of anemia. Documentation of 
the disorder requires analysis of levels of hemoglobin types 
together with measurement of red cell size. Compensatory intra-
medullary hematopoiesis, which results in bone marrow expansion, can 
lead to pathologic fractures and marked hepatosplenomegaly, 
especially in children with thalassemia major (the homozygous form) 
or those in whom the thalassemic state is combined with hemoglobin E 
(E thalassemia). We evaluate these, or any other, residual 
impairments resulting from this disorder under the criteria for the 
affected body system.
    (c) Prophylactic transfusion programs. Many children with sickle 
cell disease or thalassemia major are on prophylactic transfusion 
programs. Even though these children may have pre-transfusion 
hemoglobin values of less than 7.0 gm/dl, they are usually 
asymptomatic. Therefore, we will not use pre-transfusion hemoglobin 
values to determine if sickle cell disease or thalessemia major meet 
the requirements of 107.02A or 107.02B. We may use pre-transfusion 
hemoglobin values to evaluate these disorders in children who are 
not on prophylactic transfusion programs, or to evaluate other 
hematological disorders.
    (d) Chronic iron overload. Chronic iron overload (transfusion 
hemosiderosis) is a serious consequence of chronic transfusion 
programs. It is generally treated with iron chelation therapy. We 
will evaluate residuals of this impairment under the criteria for 
the affected body system, such as cardiovascular or digestive.
    (3) Disorders of hemostasis. (a) ``Disorders of hemostasis'' 
refers to abnormalities in the ability of the blood to clot. These 
disorders must be documented by appropriate laboratory evidence, 
including platelet counts and evaluation of plasma clotting factors 
such as Factor VIII or Factor V Leiden.
    (b) We will document the frequency, severity, and treatment of 
bleeding episodes or thromboses. Prophylactic therapy, such as 
factor concentrates or antithrombotic agents, does not, by itself, 
indicate any specific degree of severity.
    (c) We must consider complications such as development of 
inhibitors against clotting factors, intrusiveness of treatment, and 
limitation of function. We must also consider effects on other body 
systems. For example, we will evaluate hemarthrosis with joint 
deformity under 101.02, and intracranial bleeding under 111.06 or 
111.09.
    (4) Hematological malignancies. With the exception of lymphoma 
associated with human immunodeficiency virus (HIV) infection, we use 
the criteria in 113.05 (Lymphoma), 113.06 (Leukemia), and 113.28 
(Malignant neoplastic diseases treated by bone marrow or stem cell 
transplantation) to evaluate hematological malignancies. We evaluate 
lymphoma associated with HIV infection under the criteria in 
114.08E.
    H. How do we evaluate non-malignant hematological disorders 
treated by allogeneic bone marrow or stem cell transplantation? 
Allogeneic bone marrow or stem cell transplantation is performed for 
a variety of non-malignant hematological diseases, such as sickle 
cell disease and aplastic anemia. We will evaluate any non-malignant 
hematological disorder that is treated with allogeneic bone marrow 
or stem cell transplantation under 107.06, regardless of whether 
there is another listing that addresses that impairment. Under 
107.06, we consider a child disabled until at least 12 months from 
the date of transplantation. Thereafter, for purposes of evaluating 
disability, we consider any residual impairment(s), such as 
complications arising from:
    (1) Graft-versus-host (GVH) disease.
    (2) Immunosuppressive therapy, such as frequent infections.
    (3) Significant deterioration of other organ systems.

107.01  Category of Impairments, Hematological Disorders

107.02  Anemia

    A. Sickle cell disease or one of its variants, with either 1, 2, 
or 3:
    1. Documented painful (vaso-occlusive) crises requiring 
parenteral medication, occurring at least 3 times in a consecutive 
6-month period (see 107.00E).
    2. Hospitalization (for 24 hours or more) occurring at least 3 
times in a consecutive 12-month period (see 107.00E), due to any of 
the following complications of sickle cell disease:
    a. Hand/foot syndrome.
    b. Chest syndrome.
    c. Sequestration crisis.
    d. Hyperhemolytic crisis.
    e. Aplastic crisis.
    f. Stroke.
    g. Fever requiring treatment with parenteral antimicrobial 
medication.
    3. Chronic anemia manifested by persistent hemoglobin of 7.0 gm/
dl or less despite prescribed therapy (see 107.00F).
        OR
    B. Other hemolytic anemias (such as thalassemia) with chronic 
anemia manifested by persistent hemoglobin of 7.0 gm/dl or less 
despite prescribed therapy (see 107.00F).
        OR
    C. Aplastic anemia, with either 1 or 2:
    1. Chronic anemia manifested by repeated hemoglobin of 7.0 gm/dl 
or less despite prescribed therapy (see 107.00F).
    2. Documented treatment with parenteral antimicrobial medication 
occurring at least 3 times in a consecutive 12-month period (see 
107.00E).

107.03  Disorders of Hemostasis

    A. Chronic thrombocytopenia (due to any cause), with either 1 or 
2:
    1. Platelet counts repeatedly below 10,000/mm\3\ despite 
prescribed therapy (see 107.00F).
    2. Platelet counts repeatedly below 20,000/mm\3\ and spontaneous 
bleeding despite prescribed therapy requiring red cell or platelet 
transfusions at least 3 times in a consecutive 12-month period (see 
107.00E, 107.00F). Consider under a disability for 12 months from 
the date of the last transfusion. Thereafter, evaluate any residual 
impairment(s) under the criteria for the affected body system.
        OR
    B. Hemophilia with spontaneous bleeding despite prophylactic 
factor replacement, occurring at least 3 times in a consecutive 12-
month period (see 107.00E).
        OR
    C. Other hypocoagulable states (such as von Willebrand's disease 
or thrombasthenia) with spontaneous bleeding requiring 
hospitalization (for 24 hours or more), occurring at least 3 times 
in a consecutive 12-month period (see 107.00E).
        OR
    D. Hypercoagulable states (deficiency of anti-coagulant proteins 
such as protein C, protein S, and antithrombin, or the presence of 
abnormal proteins such as Factor V Leiden) with documented 
thromboses occurring at least 3 times in a consecutive 12-month 
period (see 107.00E).

107.05  Chronic Granulocytopenia (Due to Any Cause), With Both A and B

    A. Absolute neutrophil counts repeatedly below 500/mm\3\ (see 
107.00F).
        AND
    B. Documented treatment with parenteral antimicrobial medication 
occurring at least 3

[[Page 59326]]

times in a consecutive 12-month period (see 107.00E).

107.06  Non-malignant hematological diseases treated by allogeneic bone 
marrow or stem cell transplantation (see 107.00H)

    Consider under a disability until at least 12 months from the 
date of transplantation. Thereafter, evaluate any residual 
impairment(s) under the criteria for the affected body system.
* * * * *

111.00  Neurological

* * * * *
    E. Brain tumors. We evaluate malignant brain tumors under the 
criteria in 113.13. For benign brain tumors, we determine the 
severity and duration of the impairment on the basis of symptoms, 
signs, and laboratory findings (111.05).
* * * * *

111.05  Benign Brain Tumors

    Evaluate under the criteria for the resulting neurological 
impairment.
* * * * *

113.00  Malignant Neoplastic Diseases

    A. What impairments do these listings cover? We use these 
listings to evaluate all malignant neoplasms except certain 
neoplasms associated with human immunodeficiency virus (HIV) 
infection. We use the criteria in listing 114.08E to evaluate 
carcinoma of the cervix, Kaposi's sarcoma, lymphoma, and squamous 
cell carcinoma of the anus in children with HIV infection.
    B. What do we consider when we evaluate malignant neoplastic 
diseases under these listings? We consider factors such as the:
    (1) Origin of the malignancy.
    (2) Extent of involvement.
    (3) Duration, frequency, and response to antineoplastic therapy. 
Antineoplastic therapy means surgery, irradiation, chemotherapy, 
hormones, immunotherapy, or bone marrow or stem cell 
transplantation. When we refer to surgery as an antineoplastic 
treatment, we mean surgical excision for treatment, not for 
diagnostic purposes.
    (4) Effects of any post-therapeutic residuals.
    C. How do we apply these listings? Except for metastatic 
carcinoma to the brain or spinal cord (113.13C), we apply the 
criteria in a specific listing to a malignancy originating from that 
specific site.
    D. What evidence do we need? (1) We need medical evidence that 
specifies the type, extent, and site of the primary, recurrent, or 
metastatic lesion.
    (2) For operative procedures, including a biopsy or a needle 
aspiration, we need a copy of both the:
    (a) Operative note.
    (b) Pathology report.
    (3) When we cannot get these documents, we will accept the 
summary of hospitalization(s) or other medical reports. This 
evidence should include details of the findings at surgery and, 
whenever appropriate, the pathological findings.
    (4) In some situations we may also need evidence about 
recurrence, persistence, or progression of the malignancy, the 
response to therapy, and any significant residuals. (See 113.00G.)
    E. When do we need longitudinal evidence? (1) Tumors with 
distant metastases. Most malignant tumors of childhood consist of a 
local lesion with metastases to regional lymph nodes and, less 
often, distant metastases. We generally do not need longitudinal 
evidence for tumors that have metastasized beyond the regional lymph 
nodes because these tumors usually meet the requirements of a 
listing. Exceptions are for tumors with distant metastases that are 
expected to respond to antineoplastic therapy. For these exceptions, 
we usually need a longitudinal record of 3 months after therapy 
starts to determine whether the intended effect of therapy has been 
achieved and is likely to persist.
    (2) Other malignancies. When there are no distant metastases, 
many of the listings require that we consider the child's response 
to initial antineoplastic therapy; that is, the initial planned 
treatment regimen. This therapy may consist of a single modality or 
a combination of modalities (multimodal) given in close proximity as 
a unified whole, and is usually planned before any treatment(s) is 
initiated. Examples of multimodal therapy include:
    (a) Surgery followed by chemotherapy or radiation.
    (b) Chemotherapy followed by surgery.
    (c) Chemotherapy and concurrent radiation.
    (3) Types of treatment. Whenever the initial planned therapy is 
a single modality, enough time must pass to allow a determination 
about whether the therapy will achieve its intended effect. If the 
treatment fails, it will often happen within 6 months after it 
starts, and there will often be a change in the treatment regimen. 
Whenever the initial planned therapy is multimodal, a determination 
about the effectiveness of the therapy usually cannot be made until 
the effects of all the planned modalities can be determined. In some 
cases, we may need to defer adjudication until the effectiveness of 
therapy can be assessed. However, we do not need to defer 
adjudication to determine whether the therapy will achieve its 
intended effect if we can make a fully favorable determination or 
decision based on the length and effects of therapy, or the 
residuals of the malignancy or therapy (see 113.00G).
    F. How do we evaluate impairments that do not meet one of the 
Malignant Neoplastic Diseases listings?
    (1) These listings are only examples of malignant neoplastic 
diseases that we consider severe enough to result in marked and 
severe functional limitations. If the child's impairment(s) does not 
meet the criteria of any of these listings, we must also consider 
whether the child has an impairment(s) that satisfies the criteria 
of a listing in another body system.
    (2) If a child has a medically determinable impairment(s) that 
does not meet a listing, we will determine whether the impairment(s) 
medically equals or, in the case of a claim for SSI payments, 
functionally equals the listings. (See Secs. 404.1526, 416.926, and 
416.926a.) When we decide whether a child receiving SSI payments 
continues to be disabled, we use the rules in Sec. 416.994a.
    G. How do we consider the effects of therapy?
    (1) How we consider the effects of therapy under the listings. 
In many cases, malignancies meet listing criteria only if the 
therapy does not achieve the intended effect: the malignancy 
persists, progresses, or recurs despite treatment. However, as 
explained in the following paragraphs, we will not delay 
adjudication if we can make a fully favorable determination or 
decision based on the evidence in the case record.
    (2) Effects can vary widely. (a) Because the therapy and its 
toxicity may vary widely, we consider each case on an individual 
basis. We will request a specific description of the therapy, 
including these items:
    (i) Drugs given.
    (ii) Dosage.
    (iii) Frequency of drug administration.
    (iv) Plans for continued drug administration.
    (v) Extent of surgery.
    (vi) Schedule and fields of radiation therapy.
    (b) We will also request a description of the complications or 
adverse effects of therapy, such as the following:
    (i) Continuing gastrointestinal symptoms.
    (ii) Persistent weakness.
    (iii) Neurological complications.
    (iv) Cardiovascular complications.
    (v) Reactive mental disorders.
    (3) Effects of therapy may change. Because the severity of the 
adverse effects of antineoplastic therapy may change during 
treatment, enough time must pass to allow us to evaluate the 
therapy's effect. The residual effects of treatment are temporary in 
most instances. But, on occasion, the effects may be disabling for a 
consecutive period of at least 12 months.
    (4) When the initial antineoplastic therapy is effective. We 
evaluate any post-therapeutic residual impairment(s) not included in 
the Malignant Neoplastic Diseases listings under the criteria for 
the affected body system. We must consider any complications of 
therapy. When the residual impairment(s) does not meet a listed 
impairment, we must consider whether it medically equals the 
listings, or, as appropriate, functionally equals the listings.
    H. How long do we consider the child disabled? (1) In some 
listings, we specify that the impairment will be considered 
disabling until a particular point in time (for example, at least 12 
months from the date of diagnosis). We may consider the impairment 
to be disabling beyond this point when justified by the medical and 
other evidence.
    (2) When a listing does not contain such a specification, we 
will find a child whose impairment(s) meets or medically equals a 
listing in this body system to be under a disability until at least 
3 years after onset of complete remission. When the original tumor 
and any metastases have not been evident for at least 3 years after 
complete remission, the impairment(s) no longer meets or equals the 
criteria under this body system.
    (3) Following the appropriate period, we will consider any 
residual impairment(s), including residuals of the malignancy or 
therapy (see 113.00G), in determining whether the child is disabled.

[[Page 59327]]

    I. What do these terms in the listings mean?
    (1) Inoperable: Surgery was thought to be of no therapeutic 
value or the surgery could not be performed. Examples of when 
surgery cannot be performed include a tumor that is too large or 
invades crucial structures or an intolerance of anesthesia or 
surgery due to other medical conditions. This term does not include 
situations in which the tumor could have been surgically removed but 
another method of treatment was chosen; for example, an attempt at 
organ preservation. Determining whether a tumor is inoperable 
usually occurs before attempts to shrink the tumor with chemotherapy 
or radiation.
    (2) Unresectable: The operation was performed, but the malignant 
tumor was not removed. This term includes situations in which a 
tumor is incompletely resected or the surgical margins are positive.
    (3) Persistent: Failure to achieve a complete remission.
    (4) Progressive: The malignancy became more extensive after 
treatment.
    (5) Recurrent: A malignancy that had been in complete remission 
or entirely removed by surgery has returned.
    J. Can 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? Yes. We will consider factors 
such as:
    (1) The type of malignancy and its location.
    (2) The extent of involvement when the malignancy was first 
demonstrated.
    (3) Medically reported symptoms.
    K. How do we evaluate specific malignant neoplastic diseases?
    (1) Lymphoma. (a) Listing 113.05 provides criteria for 
evaluating intermediate or high-grade lymphomas that have not 
responded to antineoplastic therapy. Low grade or indolent lymphomas 
are rare in children. We will evaluate these impairments under 13.05 
in part A.
    (b) We consider Hodgkin's disease that recurs more than 12 
months after completing initial antineoplastic therapy to be a new 
disease rather than a recurrence.
    (c) Many children with lymphoma are treated according to a long-
term protocol that can result in significant adverse medical, 
social, and emotional consequences. We will consider the duration 
and effects of treatment when we determine disability (see 113.00G).
    (2) Leukemia. (a) Acute leukemia. The initial diagnosis of acute 
leukemia, including the accelerated or blast phase of chronic 
myelogenous (granulocytic) leukemia, is based upon definitive bone 
marrow examination. Additional diagnostic information is based on 
chromosomal analysis, cytochemical and surface marker studies on the 
abnormal cells, or other methods consistent with the prevailing 
state of medical knowledge and clinical practice. Recurrent disease 
must be documented by peripheral blood, bone marrow, or 
cerebrospinal fluid examination. The initial and follow-up pathology 
reports should be included.
    (b) Chronic myelogenous leukemia (CML). The diagnosis of CML 
should be based upon documented granulocytosis, including immature 
forms such as differentiated or undifferentiated myelocytes and 
myeloblasts, and a chromosomal analysis that demonstrates the 
Philadelphia chromosome. In the absence of a chromosomal analysis, 
or if the Philadelphia chromosome is not present, the diagnosis may 
be made by other methods consistent with the prevailing state of 
medical knowledge and clinical practice.
    (c) Juvenile chronic myelogenous leukemia (JCML). JCML is a 
rare, Philadelphia-chromosome-negative childhood leukemia which is 
aggressive and clinically similar to acute myelogenous leukemia. We 
evaluate JCML under 113.06A.
    (d) Elevated white cell counts. In cases of chronic leukemia, an 
elevated white cell count, in itself, is not ordinarily a factor in 
determining the severity of the impairment.
    (3) Brain tumors. We use the criteria in 113.13 to evaluate 
malignant brain tumors. We will evaluate any complications of 
malignant brain tumors, such as resultant neurological or 
psychological impairments, under the criteria for the affected body 
system. We evaluate benign brain tumors under 111.05.
    L. How do we evaluate malignant neoplastic diseases treated by 
bone marrow or stem cell transplantation? Bone marrow or stem cell 
transplantation is performed for a variety of malignant neoplastic 
diseases.
    (1) Acute leukemia (including T-cell lymphoblastic lymphoma and 
JCML), or accelerated or blast phase of CML. We consider a child who 
undergoes bone marrow or stem cell transplantation for any of these 
disorders disabled until at least 24 months from the date of 
diagnosis or relapse, or at least 12 months from the date of 
transplantation, whichever is later.
    (2) Lymphoma or chronic phase of CML. We consider a child who 
undergoes bone marrow or stem cell transplantation for either of 
these disorders disabled until at least 12 months from the date of 
transplantation.
    (3) Other malignancies. We will evaluate any other malignant 
neoplastic disease treated with bone marrow or stem cell 
transplantation under 113.28, regardless of whether there is another 
listing that addresses that impairment. The length of time we 
consider a child whose impairment is evaluated under 113.28 to be 
disabled depends on whether the child undergoes allogeneic or 
autologous transplantation.
    (a) Allogeneic bone marrow or stem cell transplantation. We will 
consider a child who undergoes allogeneic transplantation 
(transplantation from an unrelated donor or a related donor other 
than an identical twin) disabled until at least 12 months from the 
date of transplantation.
    (b) Autologous bone marrow or stem cell transplantation. We 
consider a child who undergoes autologous transplantation 
(transplantation of the child's own cells or cells from an identical 
twin (syngeneic transplantation)) disabled until at least 12 months 
from the date of the first treatment under the treatment plan that 
includes transplantation. The first treatment usually refers to the 
initial therapy given to prepare the child for transplantation.
    (4) Evaluating disability after the appropriate time period has 
elapsed. We consider any residual impairment(s), such as 
complications arising from:
    (a) Graft-versus-host (GVH) disease.
    (b) Immunosuppressant therapy, such as frequent infections.
    (c) Significant deterioration of other organ systems.

113.01  Category of Impairments, Malignant Neoplastic Diseases.

113.04  Soft Tissue Sarcoma (Including Ewing's Sarcoma, Primitive 
Neuroectodermal Tumor (PNET))

    A. Localized tumor with or without metastases. Consider under a 
disability until at least 12 months from the date of diagnosis. 
Thereafter, evaluate any residual impairment(s) under the criteria 
for the affected body system.
        OR
    B. Persistent or recurrent following initial antineoplastic 
therapy.

113.05  Lymphoma (Excluding T-Cell Lymphoblastic Lymphoma--113.06) (See 
113.00K(1))

    A. Non-Hodgkins lymphoma, including Burkitt's and anaplastic 
large cell. Persistent or recurrent following initial antineoplastic 
therapy.
        OR
    B. Hodgkin's disease with failure to achieve clinical complete 
remission, or recurrent disease within 12 months of completing 
initial antineoplastic therapy.
        OR
    C. With bone marrow or stem cell transplantation. Consider under 
a disability until at least 12 months from the date of 
transplantation. Thereafter, evaluate any residual impairment(s) 
under the criteria of the affected body system.

113.06  Leukemia (See 113.00K(2))

    A. Acute leukemia (including T-cell lymphoblastic lymphoma and 
juvenile chronic myelogenous leukemia (JCML)). Consider 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. Thereafter, evaluate any 
residual impairment(s) under the criteria for the affected body 
system.
        OR
    B. Chronic myelogenous leukemia (except JCML), as described in 1 
or 2:
    1. Accelerated or blast phase. Consider 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. Thereafter, evaluate any 
residual impairment(s) under the criteria for the affected body 
system.
    2. Chronic phase, as described in a or b:
    a. Consider under a disability until at least 12 months from the 
date of bone marrow or stem cell transplantation. Thereafter, 
evaluate any residual impairment(s) under the criteria for the 
affected body system.
    b. Progressive disease following initial antineoplastic therapy.

113.09  Thyroid Gland

    A. Anaplastic (undifferentiated) carcinoma.
        OR
    B. Carcinoma with metastases beyond the regional lymph nodes 
progressive despite radioactive iodine therapy.

[[Page 59328]]

113.10  Retinoblastoma

    A. With extension beyond the orbit.
        OR
    B. Persistent or recurrent following initial antineoplastic 
therapy.
        OR
    C. With regional or distant metastases.

113.11  Osteogenic Sarcoma

    A. Inoperable or unresectable.
        OR
    B. Recurrent tumor (except local recurrence) after initial 
antineoplastic therapy.
        OR
    C. With distant metastases.
        OR
    D. All other osteogenic sarcoma. Consider under a disability for 
12 months from the date of diagnosis. Thereafter, evaluate any 
residual impairment(s) under the criteria for the affected body 
system.

113.13  Nervous System (See 113.00K(3))

    A. Central nervous system neoplasms (brain and spinal cord), 
including:
    1. Highly malignant tumors such as Grades III and IV 
astrocytomas, glioblastoma multiforme, ependymoblastoma, 
medulloblastoma or other primitive neuroectodermal tumors (PNETs) 
with documented metastases, diffuse intrinsic brain stem gliomas, or 
primary sarcoma.
    2. Any central nervous system neoplasm progressive or recurrent 
following initial antineoplastic therapy.
        OR
    B. Peripheral nerve and spinal root neoplasm, as described in 1 
or 2:
    1. Metastatic.
    2. Progressive or recurrent following initial antineoplastic 
therapy.
        OR
    C. Metastatic carcinoma to brain or spinal cord (includes 
epidural metastases).

113.21  Kidneys and Adrenal Glands

    A. Neuroblastoma, as described in 1 or 2:
    1. With DNA index less than or equal to 1, amplified N-myc or 
unfavorable Shimada histology. Consider under a disability for 12 
months from the date of diagnosis. Thereafter, evaluate any residual 
impairment(s) under the criteria for the affected body system.
    2. For children age 1 or older with tumor crossing the midline, 
unilateral tumor with bilateral lymph node involvement, or 
disseminated tumor excluding disease confined to the skin, liver or 
bone marrow. Consider under a disability for 12 months from the date 
of diagnosis. Thereafter, evaluate any residual impairment(s) under 
the criteria for the affected body system.
        OR
    B. Wilms' tumor persistent or recurrent following initial 
antineoplastic therapy.

113.25  Testicles--Tumor With Metastatic Disease Progressive or 
Recurrent Following Initial Chemotherapy

113.26  Germ Cell Tumors--Gonadal or Extragonadal

    Persistent or recurrent following initial antineoplastic 
therapy.

113.28  Malignant Neoplastic Diseases Treated by Bone Marrow or Stem 
Cell Transplantation (See 113.00L.)

    A. Allogeneic transplantation. Consider under a disability until 
at least 12 months from the date of transplantation. Thereafter, 
evaluate any residual impairment(s) under the criteria for the 
affected body system;
        OR
    B. Autologous transplantation. Consider under a disability until 
at least 12 months from the date of the first treatment under the 
treatment plan that includes the transplantation. Thereafter, 
evaluate any residual impairment(s) under the criteria for the 
affected body system.
* * * * *

114.08  Human Immunodeficiency Virus (HIV) Infection

* * * * *
    G. Hematologic abnormalities:
    1. Anemia, as described under the criteria in 107.02A.3; or
    2. Granulocytopenia, as described under the criteria in 107.05; 
or
    3. Thromobocytopenia, as described under the criteria in 
107.03A.
* * * * *
[FR Doc. 01-29224 Filed 11-26-01; 8:45 am]
BILLING CODE 4191-02-P