[Federal Register Volume 69, Number 219 (Monday, November 15, 2004)]
[Rules and Regulations]
[Pages 67018-67038]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-24897]



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Part VI





Social Security Administration





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20 CFR Part 404



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

Federal Register / Vol. 69, No. 219 / Monday, November 15, 2004 / 
Rules and Regulations

[[Page 67018]]


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SOCIAL SECURITY ADMINISTRATION

20 CFR Part 404

[Regulations No. 4]
RIN 0960-AD67


Revised Medical Criteria for Evaluating Malignant Neoplastic 
Diseases

AGENCY: Social Security Administration.

ACTION: Final rules.

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SUMMARY: We are revising the criteria in the Listing of Impairments 
(the listings) that we use to evaluate claims involving malignant 
neoplastic diseases. We apply these criteria when you claim benefits 
based on disability under title II and title XVI of the Social Security 
Act (the Act). The revisions reflect advances in medical knowledge, 
treatment, and methods of evaluating malignant neoplastic diseases.

DATES: These rules are effective December 15, 2004.

Electronic Version

    The electronic file of this document is available on the date of 
publication in the Federal Register at http://www.gpoaccess.gov/fr/index.html. It is also available on the Internet site for SSA (i.e., 
Social Security Online): http://policy.ssa.gov/pnpublic.nsf/LawsRegs.

FOR FURTHER INFORMATION CONTACT: Martin Sussman, Regulations Officer, 
Office of Regulations, Social Security Administration, 100 Altmeyer 
Building, 6401 Security Boulevard, Baltimore, Maryland 21235-6401, 
(410) 965-1767 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, Social Security 
Online, at http://www.socialsecurity.gov/.

SUPPLEMENTARY INFORMATION: We are revising and making final the rules 
we proposed for evaluating malignant neoplastic diseases in the Notice 
of Proposed Rulemaking (NPRM) published in the Federal Register on 
November 27, 2001 (66 FR 59306). In that NPRM, we proposed revisions to 
both the listings for hematological disorders and the listings for 
malignant neoplastic diseases. We proposed to make revisions to the 
listings for these two body systems in order to update their medical 
criteria and to provide more information about how we evaluate 
disorders in these body systems. We initially provided a 60-day comment 
period that ended on January 28, 2002. Subsequently, on April 18, 2002, 
we reopened the comment period for an additional 60 days, until June 
17, 2002 (67 FR 19138). For the reasons explained below, we have 
decided to publish only revisions to the malignant neoplastic diseases 
body system in this final rule. We are publishing separately, in 
today's edition of the Federal Register, a notice withdrawing the 
proposed rules that would have revised the hematological disorders 
listings. We plan to publish a new NPRM for the hematological disorders 
listings at a later date.
    We provide a summary of the provisions of the final rules below, 
with an explanation of the changes we have made from the text in the 
NPRM. We then provide summaries of the public comments and our reasons 
for adopting or not adopting the recommendations in those comments in 
the section ``Public Comments.'' The final rule language follows the 
public comments section.

What Programs Do These Final Regulations Affect?

    These final regulations affect disability determinations and 
decisions that we make under title II and title XVI of the Act. In 
addition, to the extent that Medicare entitlement and Medicaid 
eligibility are based on whether you qualify for disability benefits 
under title II and title XVI, these final regulations also 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 if you are disabled and belong to one of the following three 
groups:
    <bullet> Workers insured under the Act.
    <bullet> Children of insured workers.
    <bullet> Widows, widowers, and surviving divorced spouses (see 
Sec.  404.336) of insured workers.
    Under title XVI of the Act, we provide for Supplemental Security 
Income (SSI) payments on the basis of disability if you are disabled 
and 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 is expected to result in death or 
which has lasted or can be expected to last for a continuous period of 
at least 12 months. Our definitions of disability are shown in the 
following table:

------------------------------------------------------------------------
                                                    Disability means you
                                                      have a medically
 If you file a claim under * *  And you are * * *       determinable
               *                                      impairment(s) as
                                                    described above and
                                                   that results in * * *
------------------------------------------------------------------------
title II......................  an adult or a      the inability to do
                                 child.             any substantial
                                                    gainful activity
                                                    (SGA).
title XVI.....................  an individual age  the inability to do
                                 18 or older.       any SGA.
title XVI.....................  an individual      marked and severe
                                 under age 18.      functional
                                                    limitations.
------------------------------------------------------------------------

How Do We Decide Whether You Are Disabled?

    If you are seeking benefits under title II of the Act, or if you 
are an adult seeking benefits under title XVI of the Act, we use a 
five-step ``sequential evaluation process'' to decide whether you are 
disabled. We describe this five-step process in our regulations at 
Sec. Sec.  404.1520 and 416.920. We follow the five steps in order and 
stop as soon as we can make a determination or decision. The steps are:
    1. Are you working and is the work you are doing substantial 
gainful activity? If you are working and the work you are doing is 
substantial gainful activity, we will find that you are not disabled, 
regardless of your medical condition or your age, education, and work 
experience. If you are not, we will go on to step 2.
    2. Do you have a ``severe'' impairment? If you do not have an 
impairment or combination of impairments that significantly limits your 
physical or mental ability to do basic work activities, we will find 
that you are not disabled. If you do, we will go on to step 3.
    3. Do you have an impairment(s) that meets or medically equals the 
severity of an impairment in the listings? If you do, and the 
impairment(s) meets the duration requirement, we will find that you are 
disabled. If you do not, we will go on to step 4.
    4. Do you have the residual functional capacity to do your past 
relevant work? If you do, we will find that you are not disabled. If 
you do not, we will go on to step 5.
    5. Does your impairment(s) prevent you from doing any other work 
that exists in significant numbers in the

[[Page 67019]]

national economy, considering your residual functional capacity, age, 
education, and work experience? If it does, and it meets the duration 
requirement, we will find that you are disabled. If it does not, we 
will find that you are not disabled.
    We use a different sequential evaluation process for children who 
apply for payments based on disability under title XVI of the Act. We 
describe that sequential evaluation process in Sec.  416.924 of our 
regulations. If you are already receiving benefits, we also use a 
different sequential evaluation process when we decide whether your 
disability continues. See Sec. Sec.  404.1594, 416.924, 416.994, and 
416.994a of our regulations. However, all of these processes include 
steps at which we consider whether your impairment meets or medically 
equals one of our listings.

What Are the Listings?

    The listings are examples of impairments that we consider severe 
enough to prevent you as an adult from doing any gainful activity. If 
you are a child seeking SSI benefits based on disability, the listings 
describe impairments that we consider severe enough to result in marked 
and severe functional limitations. Although the listings are contained 
only in appendix 1 to subpart P of part 404 of our regulations we 
incorporate them by reference in the SSI program in Sec.  416.925 of 
our regulations, and apply them to claims under both title II and title 
XVI of the Act.

How Do We Use the Listings?

    The listings are in two parts. There are listings for adults (part 
A) and for children (part B). If you are an individual age 18 or over, 
we apply the listings in part A when we assess your claim, and we do 
not use the listings in part B.
    If you are an individual under age 18, we first use the criteria in 
part B of the listings. If the listings in part B do not apply, and the 
specific disease process(es) has a similar effect on adults and 
children, we then use the criteria in part A. (See Sec. Sec.  404.1525 
and 416.925.)
    If your impairment(s) does not meet any listing, we will also 
consider whether it medically equals any listing; that is, whether it 
is as medically severe as an impairment in the listings. (See 
Sec. Sec.  404.1526 and 416.926.)

What if You Do Not Have an Impairment(s) That Meets or Medically Equals 
a Listing?

    We use the listings only to decide that individuals are disabled or 
that they are still disabled. We will not deny your claim because your 
impairment(s) does not meet or medically equal a listing. If you are 
not doing work that is substantial gainful activity, and you have a 
severe impairment(s) that does not meet or medically equal any listing, 
we may still find you disabled based on other rules in the ``sequential 
evaluation process'' described above. Likewise, we will not decide that 
your disability has ended only because your impairment(s) does not meet 
or medically equal a listing.
    Also, when we conduct reviews to determine whether your disability 
continues, we will not find that your disability has ended because we 
have changed a listing. Our regulations explain that, when we change 
our listings, we continue to use our prior listings when we review your 
case, if you had qualified for disability benefits or SSI payments 
based on our determination or decision that your impairment(s) met or 
medically equaled a listing. 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 condition(s) has 
medically improved so that you no longer meet or medically 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 Sec. Sec.  
404.1594(c)(3)(i) and 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(s). 
See Sec.  416.994a(b)(2).

Why Are We Revising the Listings for Malignant Neoplastic Diseases?

    We are revising these listings to update our medical criteria for 
evaluating malignant neoplastic diseases and to provide more 
information about how we evaluate such diseases. On April 24, 2002, we 
published final rules in the Federal Register (67 FR 20018) that 
included technical revisions to some of the listings for malignant 
neoplastic diseases. Prior to this, we last published final rules 
making comprehensive revisions to the listings for malignant neoplastic 
diseases in the Federal Register on December 6, 1985 (50 FR 50068). 
Because we have not comprehensively revised the listings for this body 
system since 1985, we believe that we need to update the rules.

What Do We Mean by ``Final Rules'' and ``Prior Rules''?

    Even though these rules will not go into effect until 30 days after 
publication of this notice, for clarity, we refer to the changes we are 
making here as the ``final rules'' and to the rules that will be 
changed by these final rules as the ``prior rules.''

When Will We Start To Use These Final Rules?

    We will start to use these final rules on their effective date. We 
will continue to use our prior rules until the effective date of these 
final rules. When the final rules become effective, we will apply them 
to new applications filed on or after the effective date of these rules 
and to claims pending before us, as we describe below.
    As is our usual practice when we make changes to our regulations, 
we will apply these final rules on or after their effective date when 
we make a determination or decision, including those claims in which we 
make a determination or decision after remand to us from a Federal 
court. With respect to claims in which we have made a final decision, 
and that are pending judicial review in Federal court, we expect that 
the court's review of the Commissioner's final decision would be made 
in accordance with the rules in effect at the time of the 
administrative law judge's (ALJ) decision, if the ALJ's decision is the 
final decision of the Commissioner. If the court determines that the 
Commissioner's final decision is not supported by substantial evidence, 
or contains an error of law, we would expect that the court would 
reverse the final decision, and remand the case for further 
administrative proceedings pursuant to the fourth sentence of section 
205(g) of the Act, except in those few instances in which the court 
determines that it is appropriate to reverse the final decision and 
award benefits without remanding the case for further administrative 
proceedings. In those cases decided by a court after the effective date 
of the rules, where the court reverses the Commissioner's final 
decision and remands the case for further administrative proceedings, 
on remand, we will apply the provisions of these final rules to the 
entire period at issue in the claim.

How Long Will These Final Rules Be Effective?

    These rules will no longer be effective 5 years after the date on 
which they become effective, unless we extend them or revise and issue 
them again.

[[Page 67020]]

Why Are We Not Publishing Final Rules for Evaluating Hematological 
Disorders in This Notice?

    The public comments we received on the NPRM raised significant 
issues about the proposed listings for some of the hematological 
disorders, and we have not finished resolving these issues. The public 
comments did not raise similar issues with respect to the listings for 
malignant neoplastic diseases. Therefore, we are issuing these final 
regulations to implement changes to the listings for malignant 
neoplastic diseases, and we summarize and respond here only to the 
significant public comments that we received about the proposed changes 
regarding those diseases.
    As noted above, we are publishing separately in today's edition of 
the Federal Register a notice withdrawing the proposed rules for the 
hematological disorders listings. We plan to issue a new NPRM for the 
hematological disorders listings at a later date.

What General Changes Are We Making That Affect Both the Adult and 
Childhood Listings for Malignant Neoplastic Diseases?

    To present the listings in a more logical order, and make them 
easier to use, we are:
    <bullet> Redesignating the listings in part A and part B. To the 
extent possible, the listings in part B correspond with listings 
addressing the same or similar impairments in part A.
    <bullet> Placing all listings for malignant neoplastic diseases in 
this body system, with the exception of certain ones associated with 
human immunodeficiency virus (HIV) infection. To do this, we are moving 
the criteria for acute leukemia, chronic leukemia, myeloma, and 
malignant brain tumors, prior listings 7.11, 7.12, 7.16, 11.05, 107.11, 
and 111.05, to final listings 13.06, 13.07, 13.13, 113.06 and 113.13, 
respectively. We are also moving the guidance for evaluating 
macroglobulinemia or heavy chain disease, prior listing 7.14, to 
13.00K3 of the introductory text because the prior listing for this 
disorder was a reference listing. As noted below, we are eliminating 
reference listings and providing guidance in the introductory text.
    <bullet> Removing reference listings from this body system. 
Reference listings are listings that are met by satisfying the criteria 
of another listing. For example, prior listing 7.16B, for myeloma with 
evidence of renal impairment, was a reference listing that requires 
evaluation under listing 6.02, for impairment of renal function. 
Instead of using reference listings, we are providing guidance in the 
introductory text stating that these impairments should be evaluated 
under the criteria for the affected body system. Where appropriate, we 
also provide references to specific listings. For example, in 13.00K3 
we indicate that macroglobulinemia or heavy chain disease should be 
evaluated under the criteria of 7.02, 7.06, or 7.08, or under the 
criteria of any other affected body system.

How Are We Changing the Introductory Text to the Listings for 
Evaluating Malignant Neoplastic Diseases in Adults?

13.00 Malignant Neoplastic Diseases

    We are expanding and reorganizing the introductory text to these 
listings to provide additional guidance and reflect the new listings. 
The following is a detailed explanation of this material.

13.00A--What Impairments Do These Listings Cover?

    In this section, we explain that 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 
14.08E to evaluate carcinoma of the cervix, Kaposi's sarcoma, lymphoma, 
and squamous cell carcinoma of the anus if you also have HIV infection.

13.00B--What Do We Consider When We Evaluate Malignant Neoplastic 
Diseases Under These Listings?

    This section corresponds to prior 13.00A, ``Introduction.'' For 
clarity, we are using the phrase ``origin of the malignancy'' instead 
of the prior language, ``the site of the lesion, the histogenesis of 
the tumor'' to describe one of the factors we consider when we evaluate 
malignant neoplastic diseases. We also changed the phrase ``apparent 
adequacy and response to therapy'' in the prior 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 treating source. We added the word 
``antineoplastic'' to be consistent with the language in the listing 
criteria. We also specifically identify the types of antineoplastic 
therapy referred to in the listings.

13.00C--How Do We Apply the Listings?

    In this section, we explain that we apply the criteria in a 
specific listing to a malignancy originating from that specific site.
    In this section of the NPRM (66 FR at 59321), we stated that 
metastatic carcinoma to the brain or spinal cord was an exception to 
the guidance above. We received a public comment questioning this 
exception. In response to this comment, we determined that this 
exception was unnecessary and have removed it. We will evaluate 
metastatic carcinoma to the brain or spinal cord under the site of 
origin for the primary tumor or, if this is unknown, under final 
listing 13.27.

13.00D--What Evidence Do We Need?

    We are expanding the guidance in prior 13.00B, ``Documentation,'' 
by:
    <bullet> Explaining that when the primary site cannot be 
identified, we will use evidence documenting the site(s) of metastasis 
to evaluate the impairment under listing 13.27.
    <bullet> Clarifying that we consider biopsies and needle 
aspirations to be ``operative procedures.''
    <bullet> Using the more general term ``pathology report'' instead 
of ``the report of the gross and microscopic examination of the 
surgical specimen.'' We made 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.

13.00E--When Do We Need Longitudinal Evidence?

    We are incorporating and expanding the guidance in the fourth 
paragraph of prior 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.

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 prior 13.00D, ``Effects of Therapy.'' We state our basic 
adjudicative principle that, if your impairment(s) does not meet or 
medically equal the requirements of a listing, we will continue the 
sequential evaluation process to determine whether you are disabled.

[[Page 67021]]

13.00G--How Do We Consider the Effects of Therapy?

    We are reorganizing the guidance in prior 13.00D, ``Effects of 
Therapy.'' In final 13.00G2a, we are adding ``extent of surgery'' and 
``schedule and fields of radiation therapy'' to the list of the 
elements of therapy for which we will request a description noted in 
the second paragraph of prior 13.00D. In final 13.00G2b, we are adding 
``neurological complications'' and ``cardiovascular complications'' to 
the list of examples of complications or adverse effects for which we 
will request a description. We are also clarifying 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.

13.00H--How Long Do We Consider Your Impairment To Be Disabling?

    We are incorporating and expanding the guidance contained in the 
third paragraph of prior 7.00E, ``Acute leukemia,'' and the fifth 
paragraph of prior 13.00C, ``Evaluation.'' In some of the listings, we 
specify that we consider an impairment to be disabling until a 
particular point in time; for example, at least 18 months from the date 
of diagnosis. If you have 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 the impairment(s) to be disabling 
until at least 3 years after onset of complete remission. We also 
explain what we do when the appropriate time period has passed.
    For those listings in which we specify that the impairment is 
considered disabling until a particular point in time, such as listing 
13.28, the beginning date specified is not related to the onset date. 
We can establish an earlier onset date if the evidence in your case 
record supports the earlier onset date, as we explain in final 13.00J.

13.00I--What Do These Terms in the Listings Mean?

    We are revising the first two paragraphs and the first sentence of 
the third paragraph of prior 13.00C, ``Evaluation,'' and providing 
additional definitions. The prior section contained 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 final listings is consistent with current 
clinical practice. We are also adding definitions in order to 
differentiate between the terms ``inoperable'' and ``unresectable.''

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 prior 13.00E, ``Onset.'' We are making 
no substantive changes.

13.00K--How Do We Evaluate Specific Malignant Neoplastic Diseases?

    We are incorporating and clarifying prior 7.00E, ``Acute 
leukemia,'' and the last sentence of the third paragraph in prior 
13.00C, ``Evaluation,'' and providing guidance for evaluating 
additional malignant neoplastic disorders. The following is a detailed 
discussion of the information provided.
13.00K1--Lymphoma
    In paragraphs K1a and K1b of this section, we discuss the 
evaluation of low grade or indolent (non-aggressive) lymphomas. We 
explain that we may defer adjudication of these cases 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 explain 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.
    Final paragraphs 13.00K1a and 13.00K1b reflect nonsubstantive 
editorial corrections made to the corresponding proposed paragraphs in 
the NPRM (66 FR at 59322). Proposed paragraph K1a referred to indolent 
lymphoma. We added a reference to low grade lymphoma to final paragraph 
K1a to be consistent with the listing language. We also added a 
reference to low grade or indolent lymphoma in final paragraph K1b for 
clarity.
    We have not retained the last sentence of the third paragraph of 
prior 13.00C, ``Evaluation.'' This sentence stated, ``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 provided useful information for applying the criteria in 
final listing 13.05.
    In paragraph K1c, we provide 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.
13.00K2--Leukemia
    In paragraph K2a, we expand the guidance in the first paragraph of 
prior 7.00E, ``Acute leukemia,'' to indicate sources of additional 
diagnostic information. We clarify that recurrent disease must be 
documented by peripheral blood, bone marrow, or cerebrospinal fluid 
examination. We also clarify that the initial and follow-up pathology 
reports should be included.
    In paragraph K2b, we provide guidance on documenting chronic 
myelogenous leukemia (CML). We have not included in this paragraph the 
guidance in the second paragraph of prior 7.00E, which provided that 
the acute phase of CML should be considered under the requirements for 
acute leukemia. Instead, we have provided a separate listing for the 
acute phase (more appropriately called the accelerated or blast phase) 
of CML, final listing 13.06B1, that uses the same criteria as the 
listing for acute leukemia (final listing 13.06A).
    In paragraph K2c, 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 from prior listing 7.12 that are appropriate for 
evaluating CLL.
    In paragraph K2d, we explain that, 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.
13.00K3--Macroglobulinemia or Heavy Chain Disease
    This section replaces prior listing 7.14, which was a reference 
listing. We are making no substantive changes in how we evaluate these 
disorders.
13.00K4--Bilateral Primary Breast Cancer
    We are clarifying the statement in prior listing 13.09D, 
``bilateral breast carcinoma, synchronous or metachronous is usually 
primary in each breast'' (emphasis added) by removing the suggestion 
that there are exceptions to this rule. See the discussion of final 
listing 13.10B, below.
13.00K5--Carcinoma-in-situ
    In this section, we explain that this type of carcinoma usually 
responds to treatment and is not included when we use the term 
``carcinoma'' in these listings.

[[Page 67022]]

13.00K6--Brain Tumors
    In this section, we explain that malignant tumors are evaluated 
under final listing 13.13, while benign tumors continue to be evaluated 
under listing 11.05. We also explain that we evaluate any complications 
of malignant brain tumors, such as resultant neurological or 
psychological impairments, under the criteria for the affected body 
system.
13.00L--How Do We Evaluate Malignant Neoplastic Diseases Treated by 
Bone Marrow or Stem Cell Transplantation?
    In paragraphs L1 and L2, we discuss how long we consider you 
disabled if you have leukemia, lymphoma, or multiple myeloma and you 
undergo bone marrow or stem cell transplantation.
    In paragraph L3, we provide that any other malignant neoplastic 
diseases treated with bone marrow or stem cell transplantation must be 
evaluated under final listing 13.28, regardless of whether there is 
another listing that addresses that impairment. We explain that under 
final listing 13.28, the length of time we will consider you disabled 
will depend on whether you undergo allogeneic or autologous 
transplantation. We also define ``allogeneic'' and ``autologous'' in 
paragraphs L3a and L3b.
    In paragraph L4, we discuss some of the factors we consider when we 
evaluate any residual impairment(s) that results from transplantation.

How Are We Changing the Listings for Evaluating Malignant Neoplastic 
Diseases in Adults?

13.01--Category of Impairments, Malignant Neoplastic Diseases

    We are removing prior listing 13.15, ``Abdomen,'' because disorders 
covered by this listing can be evaluated under other final listings. 
Prior 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 will evaluate 
these conditions under final listing 13.27, ``Primary site unknown 
after appropriate search for primary.'' We will evaluate 
``Retroperitoneal cellular sarcoma not controlled by prescribed 
therapy,'' the impairment in prior listing 13.15B, under final listing 
13.04, ``Soft tissue sarcoma.''
    In the final listings, we:
    <bullet> Take into account medical advances in the detection, 
treatment, control, and cure of malignant neoplastic diseases.
    <bullet> Recognize that in some situations the effects of therapy 
for these disorders can be disabling.
    <bullet> Provide for the evaluation of residual impairments.
    The following is a detailed explanation of the final listings.

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 prior listing 13.02, ``Head and neck.'' 
We are revising the listing heading to ensure that only tumors of the 
soft tissue of the head and neck are considered under this listing. 
This change allows us to delete the last two exceptions in the prior 
heading (orbit or temporal fossa), as these are not soft tissue tumors. 
In response to a comment, we are also removing prior listing 13.02E, 
``Epidermoid carcinoma occurring in the pyriform sinus or posterior 
third of the tongue,'' as these conditions can be evaluated under other 
sections of the final listing. We had proposed to evaluate epidermoid 
carcinoma occurring in the pyriform sinus under proposed listing 
13.02E. We explain our reasons for this change in more detail in the 
public comments section of this preamble.
    Final listing 13.02A is substantively the same as prior listing 
13.02A. We are updating the terminology to reflect the definitions used 
in the final listings.
    In final listing 13.02B, which corresponds to prior listing 13.02B, 
we are replacing ``[n]ot controlled by prescribed therapy'' with 
``[p]ersistent disease following initial multimodal antineoplastic 
therapy'' to clarify our intent.
    Final listing 13.02C corresponds to prior listing 13.02C. We are 
replacing ``after radical surgery or irradiation'' with ``following 
initial antineoplastic therapy'' to recognize that other therapeutic 
modalities may be used. We are also excluding local vocal cord 
recurrences, because these recurrences have a good response to therapy.
    Final listing 13.02D corresponds to prior listing 13.02D. We are 
making no substantive change.
    Final listing 13.02E corresponds to proposed listing 13.02F in the 
NPRM. As we have already noted, we removed prior and proposed listing 
13.02E in response to a comment. Therefore, we are redesignating 
proposed listing 13.02F as final listing 13.02E. It recognizes the 
length and debilitating effects of multimodal treatment for soft tissue 
tumors of the head and neck.

Listing 13.03--Skin

    We are combining prior listing 13.03, ``Sarcoma of skin,'' and 
prior listing 13.05, ``Malignant melanoma,'' so that all malignancies 
originating in the skin are evaluated under this listing. Accordingly, 
we are revising the heading by removing the reference to sarcoma.
    Final listing 13.03A corresponds to prior listing 13.03A, 
``Angiosarcoma with metastases to regional lymph nodes or beyond.'' We 
are expanding the provision to include all skin sarcomas and carcinomas 
because other skin malignancies of the severity described would also be 
disabling.
    Final listing 13.03B corresponds to prior listing 13.05. We clarify 
that an additional primary melanoma at a different site is not 
considered recurrent disease. We are also adding a criterion for 
palpable nodal metastases. Prior listing 13.05B addressed only 
metastases to the regional lymph nodes or beyond, and not palpable 
nodal metastases.
    We are moving prior listing 13.03B, ``Mycosis fungoides'' (a type 
of lymphoma), to final listing 13.05, ``Lymphoma,'' so that all 
lymphomas will be evaluated under the same listing.

Listing 13.04--Soft Tissue Sarcoma

    We are updating the heading of prior listing 13.04, ``Sarcoma of 
soft parts,'' to recognize that ``soft tissue'' is a more common term 
than ``soft parts.'' We are adding a criterion for regional or distant 
metastases, final listing 13.04A, to be consistent with the criteria 
for other malignant neoplastic diseases and to recognize the grave 
prognosis for these conditions. In final listing 13.04B, we define the 
prior criterion ``not controlled by prescribed therapy'' similarly to 
the way we defined it in other listings, such as final listing 13.02B.

Listing 13.05--Lymphoma (Including Mycosis Fungoides, But Excluding T-
cell Lymphoblastic Lymphoma--13.06)

    This listing corresponds to prior listing 13.06. We are changing 
the heading from ``Lymph nodes'' to ``Lymphoma'' to more accurately 
reflect the disease. We also provide a cross-reference to the 
explanatory paragraphs in 13.00K1 and 13.00K2c. This listing also 
replaces prior listing 7.13, ``Lymphomas.''
    We evaluated both Hodgkin's disease and non-Hodgkin's lymphoma 
under prior listing 13.06A. We are separating and clarifying the 
criteria for each of these diseases. Final listing 13.05A provides 
criteria for evaluating non-Hodgkin's lymphoma; final listing 13.05B 
provides criteria for Hodgkin's disease. For each of these disorders, 
we clarify the prior criteria by replacing the phrase ``progressive 
disease not

[[Page 67023]]

controlled by prescribed therapy'' in the prior listing with clearer 
language.
    In the final rules, we are making a minor editorial revision to 
proposed listing 13.05A2 for clarity. We amended the proposed listing 
by adding the words ``at least'' between ``from'' and ``the'' in the 
last sentence to clarify that the individual can be found disabled 
prior to the date specified in the listing.
    In final listing 13.05C, we 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 are removing prior 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 will evaluate this impairment under final listing 13.27, ``Primary 
site unknown after appropriate search for primary.'' We are also 
removing prior listing 13.06C. We will evaluate epidermoid carcinoma in 
a lymph node in the neck under final listing 13.02, ``Soft tissue 
tumors of the head and neck.''

Listing 13.06--Leukemia

    This final listing replaces prior listing 7.11, ``Acute leukemia,'' 
and prior listing 7.12, ``Chronic leukemia.''
    Final listing 13.06A replaces prior listing 7.11. We provide that 
acute leukemia (including T-cell lymphoblastic lymphoma) will be 
considered disabling 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 prior listing, we considered acute leukemia disabling for 
2\1/2\ years from the time of the initial diagnosis. We are shortening 
this period to 2 years because of improvement in the treatment of this 
disorder. However, as with other final listings, and unlike the prior 
listing, we permit a longer period when the facts warrant it. We also 
recognize that a relapse of acute leukemia is as significant as the 
initial diagnosis.
    The criterion for bone marrow or stem cell transplantation in cases 
of acute leukemia is similar to the transplantation criteria for other 
diseases. Unlike those diseases, however, we will not reevaluate cases 
of acute leukemia 12 months after transplantation 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 when this disease is 
treated with bone marrow or stem cell transplantation.
    Final listing 13.06B, ``Chronic myelogenous leukemia,'' replaces 
prior listing 7.12. The prior listing was a reference listing. Rather 
than replace the entire listing with guidance in the preface, we are 
providing separate evaluation criteria for CML. Consistent with our 
guidance in the second paragraph of prior 7.00E, the listing for the 
accelerated or blast phase of CML is the same as final listing 13.06A.
    We are retaining references to the listings that are appropriate 
for evaluating chronic lymphocytic leukemia in 13.00K2c.

Listing 13.07--Multiple Myeloma (Confirmed by Appropriate Serum or 
Urine Protein Electrophoresis and Bone Marrow Findings)

    This listing replaces prior listing 7.16. In this listing, we 
remove the specific findings in prior listings 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 clarify that we consider multiple myeloma treated with bone marrow 
or stem cell transplantation to be disabling 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.

Listing 13.08--Salivary Glands

    This listing redesignates prior listing 13.07. There are no 
substantive changes.

Listing 13.09--Thyroid Gland

    In the NPRM, we proposed to amend current listing 13.08, for 
malignancies of the thyroid gland, by:
    <bullet> Redesignating the current listing as proposed listing 
13.09.
    <bullet> Adding a separate criterion for anaplastic 
(undifferentiated) carcinoma in proposed listing 13.09A.
    <bullet> Redesignating the criterion in current listing 13.08, 
``carcinoma with metastases beyond the regional lymph nodes, not 
controlled by prescribed therapy,'' as proposed listing 13.09B.
    <bullet> Replacing the term ``not controlled by prescribed 
therapy'' used in current listing 13.08 with ``progressive despite 
radioactive iodine therapy'' to clarify our intent.
    On April 24, 2002, we published final rules in the Federal Register 
(67 FR 20018, 20026) that made technical revisions to the listings. 
Those rules added the criterion for anaplastic (undifferentiated) 
carcinoma and redesignated the criterion in prior listing 13.08 as 
final listing 13.08B.
    In these final rules, we are redesignating prior listing 13.08 as 
final listing 13.09, and are clarifying the language as indicated in 
the fourth bullet above.

Listing 13.10--Breast

    This listing corresponds to prior listing 13.09. In final listing 
13.10A, we are amending the criterion in prior listing 13.09B, 
``Inflammatory carcinoma,'' by adding other types of locally advanced 
carcinoma.
    In final listing 13.10B, ``Carcinoma with distant metastases,'' we 
are revising prior listing 13.09D by removing the parenthetical 
statement ``bilateral breast carcinoma, synchronous or metachronous, is 
usually primary in each breast.'' Instead, we provide guidance about 
evaluating bilateral breast cancer in final 13.00K4. 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 final listing 13.10C, which replaces prior listing 13.09C, we 
are replacing the term ``controlled by prescribed therapy'' used in the 
prior listing with ``that remits with antineoplastic therapy'' to 
clarify our intent.
    We are removing prior 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 final listing 13.10. We are also removing prior listing 
13.09E, ``Sarcoma with metastases anywhere.'' We will evaluate this 
impairment under final listing 13.04, ``Soft tissue sarcoma.''

Listing 13.11--Skeletal System

    This listing replaces prior listing 13.10. We are expanding the 
listing to include tumors of the mandible that were evaluated under 
prior listing 13.11. In final listings 13.11A, 13.11B, and 13.11C, we 
revise prior listing 13.10A to clarify when these tumors are of 
listing-level severity. In final listing 13.11D, we provide that we 
consider all other malignant tumors originating in bone with multimodal 
antineoplastic therapy to be disabling for 12 months from the date of 
diagnosis. Consistent with the changes we have made for other listings, 
any residual impairment(s) will be evaluated under

[[Page 67024]]

the criteria for the affected body system after that period. With this 
criterion, we recognize the length and debilitating effects of 
multimodal treatment for these tumors.

Listing 13.12--Maxilla, Orbit, or Temporal Fossa

    This listing corresponds to prior listing 13.11. As noted above, we 
evaluate tumors of the mandible under final listing 13.11. Final 
listings 13.12A and 13.12B reorganize the criteria in prior listings 
13.11A and 13.11B by moving the criterion for carcinoma with regional 
or distant metastases (part of prior listing 13.11B) to final listing 
13.12A. We did this so that all tumors of the maxilla, orbit, or 
temporal fossa with regional or distant metastases would be covered in 
the same listing. The final listings do not make any substantive 
changes.
    In the NPRM, we inadvertently changed the word ``temporal'' in the 
heading of current listing 13.11 to ``infratemporal'' in the heading of 
proposed listing 13.12 (66 FR at 59323). We are correcting the heading 
in these final rules. Additionally, although we moved the criterion for 
carcinoma with regional or distant metastases to proposed listing 
13.12A, we failed to remove the criterion from proposed listing 13.12B. 
We are removing the criterion from final listing 13.12B in response to 
a public comment indicating that retaining the criterion in listing 
13.12B was redundant.
    In final listing 13.12C, we consolidate the disease sites in prior 
listings 13.11C, 13.11D, 13.11E, and 13.11F.

Listing 13.13--Nervous System

    This listing incorporates the criteria for malignant brain tumors 
from listing 11.05, ``Brain tumors,'' in the neurological body system, 
and replaces prior listing 13.12, ``Brain or spinal cord.'' We are 
expanding the listings to include tumors of the spinal cord, spinal 
nerve roots, and the peripheral nervous system. We are also including 
tumors of the central nervous system that are not specifically named.
    Under final listing 13.13A, we evaluate central nervous system 
malignant neoplasms; that is, those affecting the brain or spinal cord. 
In final listing 13.13A1, we list and revise the criteria for the 
impairments named in prior listing 11.05A. We are revising 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 prior listing 11.05B, under final listing 13.13A2.
    We are also adding diffuse intrinsic brain stem gliomas in final 
listing 13.13A1. We are requiring 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 the NPRM, the criteria in proposed listing 13.13A were preceded 
by the phrase, ``Central nervous system neoplasms (brain and spinal 
cord), including * * *.'' In final listing 13.13A, we are changing the 
word ``including'' to the phrase ``as described in 1 or 2'' to be 
consistent with other listings.
    In final listing 13.13B, we provide criteria for evaluating 
malignant tumors of peripheral nerves and spinal roots.
    In the NPRM, we had proposed a listing, listing 13.13C, to 
correspond to prior listing 13.12A for metastatic carcinoma to brain or 
spinal cord. In response to a public comment, we have determined that 
this listing is unnecessary. These malignancies will be evaluated under 
the criteria for the site of origin, or under listing 13.27 if the 
primary site is unknown. Therefore, we are removing prior listing 
13.12A and proposed listing 13.13C. We are also removing prior listing 
13.12B, which was a reference listing.

Listing 13.14--Lungs

    This listing corresponds to prior listing 13.13. In final listing 
13.14A, we consolidate prior 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.
    In the NPRM, proposed listing 13.14A covered metastatic disease to 
or beyond the mediastinal or subcarinal lymph nodes. A public comment 
pointed out that this criterion would exclude cases of non-small-cell 
carcinomas with metastases to the hilar lymph nodes that had been 
included under prior listing 13.13E. The comment also indicated that, 
even when the involved hilar nodes are excised, the prognosis for this 
disease is unfavorable. In response to this comment, we have revised 
final listing 13.14A to include metastases to the hilar nodes.
    We are redesignating prior listing 13.13C as final listing 13.14B. 
We are making no substantive changes.

Listing 13.15--Pleura or Mediastinum

    This listing corresponds to prior listing 13.14. Final listing 
13.15A is the same as prior listing 13.14A. In final listing 13.15B, 
which corresponds to prior listing 13.14C, we provide new language that 
clarifies the phrase ``not controlled by prescribed therapy'' used in 
the prior listing.
    In the NPRM, the criterion in proposed listing 13.15B1 was 
``Metastatic.'' In final listing 13.15B1, we revise this criterion to 
``With metastases to or beyond the regional lymph nodes'' to be 
consistent with the other listings in these rules.
    We are removing prior listing 13.14B, ``Malignant tumors, 
metastatic to pleura.'' We will evaluate this malignancy under final 
listing 13.27, ``Primary site unknown.''

Listing 13.16--Esophagus or Stomach

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

Listing 13.17--Small Intestine

    This listing corresponds to prior listing 13.17. In final listing 
13.17A, we expand the criterion in prior listing 13.17B, for recurrent 
malignancies, to indicate that inoperable and unresectable malignancies 
are also of listing-level severity. We also provide new language to 
clarify the phrase ``not controlled by prescribed therapy'' used in 
prior listing 13.17C. Final listing 13.17B corresponds to prior listing 
13.17A, and is substantively unchanged.

Listing 13.18--Large Intestine (From Ileocecal Valve to and Including 
Anal Canal)

    This listing corresponds to prior listing 13.18. We are removing 
the phrase ``carcinoma or sarcoma'' from the heading of this listing 
because sarcomas of the large intestine are extremely rare. In final 
listing 13.18A, we consolidate prior listings 13.18A and 13.18C and 
clarify that these criteria apply to adenocarcinoma. In final 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. 
Final listing

[[Page 67025]]

13.18C is the same as prior listing 13.18B.

Listing 13.19--Liver or Gallbladder

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

Listing 13.20--Pancreas

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

Listing 13.21--Kidneys, Adrenal Glands, or Ureters

    This listing corresponds to prior listing 13.21. In final listing 
13.21A, we expand the criteria of unresectable tumors in prior listing 
13.21A to include inoperable and recurrent tumors. Final listing 13.21B 
consolidates prior listings 13.21B and 13.21C. We are eliminating the 
modifier ``hematogenous'' used in prior listing 13.21B because 
metastases by lymphatic spread or by direct extension carry the same 
poor prognosis.

Listing 13.22--Urinary Bladder

    This listing corresponds to prior listing 13.22. We are removing 
prior listing 13.22E, which provided for the evaluation of renal 
impairment following total cystectomy under the criteria in listing 
6.02, because it was a reference listing.

Listing 13.23--Cancers of the Female Genital Tract

    In this listing, we incorporate and revise prior listings 13.25, 
``Uterus,'' 13.26, ``Ovaries,'' 13.28, ``Uterine (Fallopian) tubes,'' 
and 13.30, ``Vulva.''
    In final listings 13.23A, ``Uterus (corpus),'' and 13.23B ``Uterine 
cervix,'' we replace the prior 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 final listing 13.23C, ``Vulva,'' we provide 
criteria in addition to the criteria for distant metastases used in the 
prior listing.
    We are making several changes in final listing 13.23D, ``Fallopian 
tubes.'' In final listing 13.23D1, `` Extending to the serosa or 
beyond,'' we replace the criteria in prior 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. In final 
listing 13.23D2, we are also adding criteria to evaluate fallopian tube 
tumors when the initial antineoplastic therapy has not achieved the 
desired effect.
    In final listing 13.23E, ``Ovaries,'' we separate germ-cell and 
non-germ-cell tumors. In final listing 13.23E1, which provides the 
criteria for evaluating non-germ-cell tumors, we expand the criteria in 
prior listing 13.26 to reflect advances in diagnostic techniques and 
treatment. We provide criteria for evaluating germ-cell tumors in final 
listing 13.23E2.

Listing 13.24--Prostate Gland

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

Listing 13.25--Testicles

    This listing corresponds to prior listing 13.24. We are removing 
prior listing 13.24A, for choriocarcinoma because the literature we 
consulted does not separate choriocarcinoma from other forms of 
nonseminomatous germ-cell tumors with regard to staging or treatment. 
(See 67 FR 19138 for a list of the literature we consulted.)

Listing 13.26--Penis

    This listing corresponds to prior listing 13.29. We have clarified 
the listing to explicitly include metastases to or beyond the regional 
lymph nodes.

Listing 13.27--Primary Site Unknown After Appropriate Search for 
Primary

    We are providing a listing for the occasional case in which 
metastases have been appropriately verified but the site of the primary 
malignancy cannot be determined. The final listing specifically 
excludes solitary squamous cell carcinoma in the neck, as this type of 
metastasis is often amenable to treatment.

Listing 13.28--Malignant Neoplastic Diseases Treated by Bone Marrow or 
Stem Cell Transplantation

    As we have already noted in our discussion of final 13.00L above, 
final listing 13.28 is a listing for bone marrow or stem cell 
transplantation in any malignant neoplastic disease other than acute 
leukemia, CML, lymphoma, or multiple myeloma, which we evaluate under 
final listings 13.05, 13.06 and 13.07. In final listing 13.28A, we 
provide that allogeneic transplantation is disabling until at least 12 
months from the date of transplantation. In final listing 13.28B, we 
provide that autologous transplantation is disabling 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 Changing the Introductory Text to the Listings for 
Evaluating Malignant Neoplastic Diseases in Children?

113.00 Malignant Neoplastic Diseases

    Except for minor changes to refer to children, we are repeating 
much of the introductory text in 13.00 in the introductory text in 
113.00. This is because the same basic rules for establishing and 
evaluating the existence and severity of malignant neoplastic diseases 
in adults also apply to children. Because we have already described 
these provisions under the explanation of 13.00, the following 
discussions describe only those provisions that are unique to the 
childhood rules or that require further explanation.

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

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

113.00D--What Evidence Do We Need?

    In this section, we replace and expand prior 113.00B. This section 
is substantively the same as final 13.00D. We are not including a 
childhood listing to correspond to final listing 13.27, primary site 
unknown after appropriate search for primary, because the inability to 
determine the primary site is an extremely rare occurrence in childhood 
malignancies. Instead, we indicate that, in these rare situations, we 
will use final listing 13.27.

[[Page 67026]]

113.00E--When Do We Need Longitudinal Evidence?

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

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 final 13.00F, but use 
the definition of disability for children who claim SSI payments.

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

    This section replaces prior 113.00A2 and the last paragraph of 
prior 113.00A. We repeat the guidance in final 13.00G but use the 
definition of disability for children who claim SSI payments.

113.00H--How Long Do We Consider Your Impairment To Be Disabling?

    This section corresponds to final 13.00H. It also replaces prior 
113.00D, ``Duration of disability,'' which referred to the specific 
time periods that we included in prior listings 113.02 and 113.03. 
Although we do not cite specific listings, we indicate that some 
listings specify that the impairment should be considered disabling 
until a particular point in time. In final 113.00H2, we state that, 
when the listing does not contain such a specification, we will 
consider an impairment that meets or medically equals the listings in 
this body system to be disabling until at least 3 years after onset of 
complete remission. We added this section to ensure consistency between 
the adult and childhood rules.

113.00I--What Do These Terms in the Listings Mean?

    This section corresponds to final 13.00I. As we explain below, we 
are retaining our listings for malignant solid tumors. Because of this, 
there are no listings in part B of these final rules that include the 
terms ``inoperable'' and ``unresectable.'' Therefore, in these final 
rules, we revised proposed 113.00I to remove the definitions of those 
terms.

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

    In this section, we incorporate the discussion in prior 107.00C, 
``Acute leukemia,'' and provide guidance for other childhood 
malignancies. Except for minor changes to refer to children, final 
113.00K4, ``Brain Tumors,'' is the same as final 13.00K6. The following 
is a discussion of the other malignant neoplastic diseases addressed in 
this section.
113.00K1--Lymphoma
    In this section, we indicate that final listing 113.05 should not 
be used for evaluating low grade or indolent lymphomas because they are 
rare in children. We will evaluate these lymphomas under final listing 
13.05. We also indicate that many children with lymphoma are treated 
according to a long-term protocol that can result in significant 
adverse medical, social, and emotional consequences. We provide a 
reference to final 113.00G to evaluate those consequences.
113.00K2--Leukemia
    In final 113.00K2c, we provide a description of juvenile CML (JCML) 
and explain that we will evaluate it under final listing 113.06A.
    Final 113.00K2d is similar to final 13.00K2d. We did not include a 
discussion about chronic lymphocytic leukemia, as in final 13.00K2c, 
because the disorder is extremely rare in children.
113.00K3--Malignant Solid Tumors
    In this section, we incorporate the guidance in prior 113.00C, 
``Malignant solid tumors.'' We have revised the reference to the 
listing for brain tumors because that listing is now in this body 
system. As we have added a listing for the thyroid gland, we no longer 
need guidance in the introductory text explaining how thyroid tumors 
should be evaluated.
113.00K5--Retinoblastoma
    In this section, we state that treatment for bilateral 
retinoblastoma usually results in a visual impairment and that we will 
evaluate any resulting visual impairment under listing 102.02.

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 final 13.00L1, 
13.00L2, and 13.00L4. We have added JCML to the heading of 13.00L1 to 
reflect that JCML is included in final listing 113.06A. We do not refer 
to multiple myeloma in final 113.00L2 because this impairment is not 
included in the final childhood listings. Multiple myeloma is extremely 
rare in children.
    In the NPRM, we had also proposed a section in part B, similar to 
final 13.00L3, that contained guidance on how to evaluate bone marrow 
or stem cell transplantation for other disorders in children. That 
section, proposed 113.00L3, indicated that malignant neoplastic 
diseases treated with bone marrow or stem cell transplantation should 
be evaluated under proposed listing 113.28. Proposed listing 113.28 was 
one of several listings that we proposed as a replacement for prior 
listing 113.03, ``Malignant solid tumors.'' As we explain in the public 
comments section of this preamble, we have decided not to change our 
prior criteria for malignant solid tumors in these final rules. 
Therefore, we do not need the guidance we included in proposed section 
113.00L3, and we are not including it in these final rules. As we 
indicate in response to a public comment on bone marrow or stem cell 
transplantation in chidren, final listing 13.28 can be used in those 
few cases in which the end of the 2-year period provided by final 
listing 113.03 is earlier than the end of the period that the 
impairment would be considered disabling based on the bone marrow or 
stem cell transplantation.

How Are We Changing the Listings for Evaluating Malignant Neoplastic 
Diseases in Children?

113.01 Category of Impairments, Malignant Neoplastic Diseases

    We are redesignating 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 
final childhood listings are not consecutive.

Listing 113.03--Malignant Solid Tumors

    This listing corresponds to prior listing 113.03, ``Malignant Solid 
Tumors.'' We are making minor editorial changes to make the language 
consistent with that used in other listings and to indicate that, after 
the appropriate time period has passed, any residual impairment should 
be evaluated under criteria for the affected body system.
    In the NPRM, we proposed removing prior listing 113.03 and 
providing separate listings for specific types of malignant solid 
tumors and a listing for malignant neoplastic diseases treated by bone 
marrow or stem cell transplantation. In response to a comment, we have 
decided to retain prior listing 113.03 as we further consider how to 
include solid tumors in children in our listings. Because we are 
retaining prior listing 113.03 in these final rules, we are not 
incorporating the proposed listings that would have replaced it: 
Proposed listing 113.04, ``Soft Tissue Sarcoma (including Ewing's 
Sarcoma, Primitive Neuroectodermal Tumors (PNETs)''; proposed listing 
113.11, ``Osteogenic Sarcoma''; proposed listing 113.13A2,

[[Page 67027]]

for any central nervous system neoplasm progressive or recurrent 
following initial antineoplastic therapy; proposed listing 113.13B, for 
peripheral nerve or spinal root neoplasm; proposed listing 113.21B, for 
Wilms' tumor persistent or recurrent following initial Antineoplastic 
therapy; proposed listing 113.25, ``Testicles--Tumor With Metastatic 
Disease Progressive of Recurrent Following Initial Chemotherapy''; 
proposed listing 113.26, ``Germ Cell Tumors--Gonadal or Extragonadal''; 
and proposed listing 113.28, ``Malignant Neoplastic Diseases Treated by 
Bone Marrow or Stem Cell Transplantation.''

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

    This listing corresponds to prior listing 113.02, ``Lymphoreticular 
malignant neoplasms.'' We are revising the listing to make it more 
consistent with final listing 13.05.
    Final listing 113.05A replaces the criteria for non-Hodgkin's 
lymphoma in prior 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 impairment may be disabling for less than 12 months. Due to 
these advances in treatment, it is no longer appropriate to assume that 
the impairment will meet the statutory duration requirement. Instead, 
we will find the impairment disabling under this listing when it is 
persistent or recurrent following initial antineoplastic therapy. We 
also clarify that non-Hodgkins lymphoma includes Burkitt's and 
anaplastic large cell.
    Final listing 113.05B replaces the criteria for Hodgkin's disease 
in prior listing 113.02A. With the final criterion, we clarify what we 
meant by ``progressive disease not controlled by prescribed therapy'' 
in the prior listing.
    In final listing 113.05C, we add a criterion for bone marrow or 
stem cell transplantation.

Listing 113.06--Leukemia

    This listing replaces prior listing 107.11, ``Acute leukemia.'' In 
final listing 113.06A, for ``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 final listing 13.06A, and are explained in the discussion of 
that listing.
    In final listing 113.06B, which is the same as final listing 
13.06B, we added criteria for evaluating CML other than JCML.

Listing 113.09--Thyroid Gland

    This listing is the same as final listing 13.09 and incorporates 
the guidance contained in prior 113.00C. The listing criteria define 
when the malignancy is not controlled by prescribed therapy.

Listing 113.12--Retinoblastoma

    This final listing revises prior listing 113.05. We are removing 
prior listing 113.05A, for bilateral involvement, because with advances 
in treatment this malignancy is often treated successfully. As we 
indicate in final 113.00K4, we will evaluate the resulting visual 
impairment under listing 102.02. If treatment is not successful, we 
will evaluate the impairment under the other criteria in the final 
listing.
    Final listing 113.12A corresponds to prior listing 113.05C. We are 
making no substantive changes.
    Final listing 113.12B corresponds to prior listing 113.05D. We are 
revising the criteria to recognize that persistence after treatment, as 
well as recurrence, indicates a poor prognosis.
    Final listing 113.12C corresponds to prior listing 113.05B. We are 
revising the description to make it clear that any metastatic disease 
is included under the listing.

Listing 113.13--Brain Tumors

    This listing revises the criteria for malignant brain tumors in 
prior listing 111.05, ``Brain tumors.'' We use the same criteria for 
evaluating brain tumors in children as in final listing 13.13A1.
    In the NPRM, we proposed to expand the criteria in this listing to 
address other tumors of the nervous system. As explained above, we have 
decided to retain our prior criteria for evaluating malignant solid 
tumors, and these additional criteria are not needed. Because we are 
not including the additional criteria, we have revised the heading of 
this listing to reflect the types of tumors evaluated under it.

Listing 113.21--Neuroblastoma

    Final listing 113.21A corresponds to prior listing 113.04, 
``Neuroblastoma.'' We have made minor editorial revisions to be 
consistent with other listings.
    In the NPRM, we proposed changing the criteria for neuroblastoma. 
As explained above, we have decided to retain our prior criteria for 
malignant solid tumors as we further consider how to include solid 
tumors in children in our listings. Similarly, we have decided to 
retain our prior criteria for neuroblastoma.
    We also proposed to expand the criteria in this listing to address 
Wilms' tumors. Because we are retaining our prior criteria for 
malignant solid tumors, this additional criterion is not needed. 
Therefore, we have revised the heading of this listing to reflect the 
types of tumors evaluated under it.

What Other Revisions Are We Making?

    Consistent with the changes explained above, we are also:
    <bullet> Changing the name of 7.00 and 107.00 from Hemic and 
Lymphatic System to Hematological Disorders. We are making this change 
because we are moving the lymphatic impairments now contained in these 
body systems to 13.00 and 113.00.
    <bullet> Revising the heading of listing 7.17 to remove the 
reference to hematologic malignancies. We are making this change 
because we are moving the listings for hematological malignancies to 
13.00 and 113.00.
    <bullet> Revising 11.00B to indicate that malignant brain tumors 
should be evaluated under the criteria in listing 13.13.
    <bullet> Adding 111.00E to provide the same guidance as final 
11.00B.
    <bullet> Revising prior listings 11.05 and 111.05 by removing the 
criteria for malignant brain tumors. In the NPRM, proposed listing 
11.05 indicated that benign brain tumors would be evaluated under 
11.02, 11.03, 11.04A or B, or 12.02. Proposed listing 111.05 indicated 
that these tumors would be evaluated under the criteria for the 
resulting neurological impairment. As we reviewed these criteria, we 
realized that these listings should be the same. We also realized that 
they should allow for the evaluation of all complications of benign 
brain tumors. Therefore, we have replaced the reference to 12.02 with 
``the criteria of the affected body system'' and revised final listing 
111.05 for consistency between the adult and childhood listings.
    <bullet> Making nonsubstantive editorial changes throughout these 
rules to reflect the technical changes that were implemented by the 
final regulation we published in the Federal Register on April 24, 
2002, (67 FR 20018), to correct typographical errors and omissions, to 
make the language clearer, and to be consistent with other rules.

Public Comments

    In the NPRM we published in the Federal Register on November 27, 
2001 (66 FR 59306), we provided the public with a 60-day comment period 
that ended on January 28, 2002. Due to some significant issues raised 
by commenters, we provided an additional 60-day

[[Page 67028]]

public comment period by publishing a notice in the Federal Register on 
April 18, 2002 (67 FR 19138). The additional comment period ended on 
June 17, 2002.
    In response to the two notices, we received comments from 61 
commenters, 16 of whom addressed the proposed criteria for malignant 
neoplastic diseases. These 16 commenters included medical 
organizations, legal services organizations, State agencies that make 
disability determinations for us, and individuals. Many of the 
commenters raised more than one issue. We carefully considered all of 
the comments.
    A number of the comments were quite long and detailed, requiring us 
to condense, summarize, or paraphrase them. We have tried to accurately 
present all views of the commenters and have tried to respond to all of 
the significant issues raised by the commenters. We provide our reasons 
for adopting or not adopting the comments in our responses below.

General Comments

Extend the Comment Period and Provide the Medical and Scientific 
Justification for the Proposed Listings.

    Comment: During the initial comment period, several commenters 
asked us to extend the 60-day comment period due to the length and 
complexity of the proposed rules. Commenters also asked us to provide 
the medical and scientific justification for these changes.
    Response: As we reviewed the initial comments, we realized that 
significant issues were being raised, and we determined that it would 
be appropriate to reopen the comment period in order to get additional 
input on those and other issues. Therefore, on April 18, 2002, we 
published a notice in the Federal Register (67 FR 19138) reopening the 
comment period and providing an additional 60-day period within which 
to comment. The additional comment period ended on June 17, 2002. The 
notice that reopened the comment period included references to the 
medical and scientific sources we consulted when developing the NPRM, 
and invited comment on those references as well.

The Proposed Listings are More Restrictive Than the Prior Listings

    Comment: Some commenters believed that these criteria reflect a 
trend toward an increased level of severity in the listings. One 
commenter noted that, although good arguments may be made for these 
changes, the criteria in the childhood listings for non-Hodgkin's 
lymphoma, chronic granulocytic leukemia, thyroid carcinoma, 
medulloblastoma, Wilms' tumor, testicular cancer, and germ-cell tumors 
were more restrictive.
    Response: As we reviewed our proposed listings to respond to the 
public comments, we realized that we need to consider further how to 
address childhood malignant solid tumors in our listings. In the 
interim, we are retaining our prior criteria that provide that 
malignant solid tumors, other than brain tumors or thyroid tumors, are 
disabling for 2 years from the date of initial diagnosis or from the 
date of recurrence of active disease. We are also retaining our prior 
criteria for neuroblastoma.

Impact of the Changes

    Comment: Two commenters stated that the proposed rules would result 
in a considerable reduction in the number of individuals eligible for 
disability benefits and requested that we provide an estimate of the 
impact of these changes.
    Response: Based on our assessment of these rules, we do not believe 
that a considerable number of individuals will be adversely affected by 
the changes we are making in these final rules. We believe that these 
final rules appropriately reflect advances in medical knowledge, 
treatment, and methods for evaluating malignant neoplastic diseases.
    Comment: One commenter expressed concern that these rules would 
result in fewer claims being allowed at step 3 of the sequential 
evaluation process, and that a functional assessment would be required 
in more cases.
    Response: Based on our assessment of these rules, we do not believe 
that fewer claims will be allowed at step 3 of the sequential 
evaluation process.

The Proposed Listings May Result in Delays

    Comment: Several commenters expressed concern that it will take 
longer to evaluate some malignancies because the proposed listings for 
these malignancies require that the treatment has not been effective. 
Some of these commenters believed that evaluation of these malignancies 
would need to be delayed until treatment was completed. One commenter 
thought that we would not evaluate cases at other steps in the 
sequential evaluation process while we were waiting to determine the 
effectiveness of the treatment. One commenter thought that deferring 
adjudication in these cases would result in more informed decisions and 
prevent us from denying some cases in error.
    Response: While we agree that these final rules may delay the 
adjudication of some cases, we do not believe the number of affected 
cases will be significantly more than under the prior rules. The prior 
listings for most of these malignancies also included a requirement 
that the impairments not be controlled by prescribed therapy. To make 
this determination under the prior rules, we also had to allow 
sufficient time to determine whether the impairments would be 
controlled.
    When we can determine whether treatment will be effective before 
the treatment regimen is completed, we will make the decision about 
whether the malignancy is of listing-level severity at that point. 
Additionally, as we state in final 13.00E3 and 113.00E3, we will not 
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.

Focus on the Individual's Particular Situation

    Comment: One commenter stressed the importance of focusing on an 
individual's particular situation, especially when he or she has 
significant limitations past the listed disability time period. The 
commenter stated that cancer patients typically incur short-term 
impairments resulting from toxicities associated with chemotherapy and 
other treatment, and from the disease itself. The commenter also noted 
that impairments from treatment, such as cardiotoxicity and 
infertility, can manifest several years later, and that a tumor may 
cause disability to a patient for a period of time far surpassing that 
which has been allocated by the proposed regulations for certain 
malignant neoplastic diseases. The commenter believed that it is 
essential that the new regulations maintain sufficient flexibility to 
adequately adjust disability time periods based on the individualized 
nature of cancer and patient responses to treatment of the disease.
    Another commenter believed that the proposed rules did not 
adequately address problems with fatigue, energy levels and ability to 
sustain work for normal periods of time. The commenter also requested 
that we consider the lack of immunity to infection from which many 
individuals with cancer suffer.
    Response: We believe these final regulations do allow sufficient 
flexibility to adjust the period of time the individual is considered 
disabled and stress the importance of considering residual 
impairment(s) or symptoms

[[Page 67029]]

caused by the disease or the treatment. However, the severity of any 
residual impairment(s) or symptom can vary greatly, and must be 
evaluated on an individualized, case-by-case basis. If a severe 
residual impairment(s) does not meet or medically equal any listing, we 
will evaluate the impact of the impairment(s), as well as the impact of 
any symptoms caused by the disease or the treatment, at later steps in 
the sequential evaluation process.

The Listings Need Timely Review

    Comment: Two commenters stated that these listings will need timely 
review in the future to keep up with advances in treatment and to 
ensure that they reflect current medical knowledge.
    Response: We agree that the listings should continue to reflect the 
latest medical knowledge and advances in treatment. We intend to 
monitor these listings and to update the criteria for any impairment 
contained in these listings as the need arises. For this reason, we are 
indicating that these rules will be in effect for 5 years after they 
become effective, unless we extend them or revise and issue them again.

Comments on the Introductory Text

Provide Additional Definitions

    Comment: Two commenters asked us to include definitions of 
``regional lymph nodes'' and ``distant metastases'' in the introductory 
text.
    Response: As we indicated in our explanation of 13.00I, our intent 
is to use these terms as they are used in current clinical practice. In 
clinical practice, these terms are defined in relation to the site of 
the primary malignancy. To define these terms in our listings, we would 
need a separate definition for each primary site specified in the 
listings. Our adjudicative experience has shown that the medical 
evidence usually indicates whether the malignancy has spread to the 
regional lymph nodes or beyond. Therefore, we do not believe it is 
practicable or necessary to add these definitions to the introductory 
text. Instead, we will rely on the description of the malignancy 
contained in the medical records.
Documenting Complete Remission
    Comment: One commenter requested that we add a discussion of the 
documentation required to establish a ``complete remission.''
    Response: We partially adopted this comment by revising final 
13.00H2 and 113.00H2 to clarify that ``complete remission'' occurs when 
the original tumor and any metastases are no longer evident. However, 
we did not add a discussion about the documentation we require to 
establish a complete remission. The treating source will determine the 
methods of evaluating complete remission for the particular malignancy 
for each individual patient. We will usually rely on the documentation 
provided by the treating source.
13.00 K2c--Chronic Lymphocytic Leukemia
    Comment: One commenter noted that chronic lymphocytic leukemia 
(CLL) is mentioned only in the introductory text and believed that this 
is a potential source of confusion. The commenter requested that CLL be 
added to the heading of proposed listing 13.05, Lymphoma, and included 
in the criteria in proposed listings 13.05A1 and 13.05A2, which address 
non-Hodgkin's lymphoma.
    Response: We partially adopted the comment. The complications of 
CLL are diverse and, because of this, it is not always appropriate to 
evaluate CLL using the criteria for lymphoma. By maintaining the 
references in the introductory text, we provide the flexibility needed 
to evaluate this disorder. We have, however, included a reference to 
13.00K2c in the heading of final listing 13.05 as a reminder that CLL 
may be evaluated under this listing when appropriate.

Evaluation of Hodgkin's Disease That Recurs More Than 1 Year After 
Completion of Therapy

    Comment: One commenter disagreed with our proposed rule in 13.00K1c 
to consider Hodgkin's disease that recurs more than 12 months after the 
completion of initial antineoplastic therapy as new disease under the 
listings, rather than a recurrence. The commenter indicated that 
oncologists would consider such patients as having relapsed, rather 
than as having developed a new disease.
    Response: We agree that, for treatment purposes, Hodgkin's disease 
that recurs more than 12 months after the completion of therapy should 
not be considered as new disease. However, Hodgkin's disease frequently 
remits within 12 months of the initiation of treatment, and the period 
of remission is often longer than 12 months. In these instances, the 
impairment would not satisfy the statutory duration requirement. If the 
disease then recurs, we have to consider it as a new disease for 
purposes of determining whether the duration requirement will be met. 
Additionally, secondary treatment for a recurrence after 12 months can 
result in complete remission or cure.

Comments on the Listing Criteria

Add Additional Criteria

    Comment: Several commenters suggested that we add specific 
additional malignancies to the listings. One commenter expressed 
concern that malignancies that are not contained in the listings 
because they are rare or because they are often amenable to treatment 
will not be properly evaluated. The commenter indicated that there are 
no instructions as to how to adjudicate the cases of individuals who do 
not respond well to treatment, and believed that there was no guidance 
for evaluating any cases on a case-by-case basis. The commenter also 
believed it is not acceptable to rely on the sequential evaluation 
process, since that process is often difficult to enforce and apply 
uniformly to people of all age groups. The commenter said this is 
especially true for children. The commenter suggested that these 
regulations include a full listing of any malignancy that is of 
listing-level severity.
    Response: We have not added the specific malignancies suggested by 
the commenters. In some instances, we believe the malignancies are 
already included in the final rules. For example, one commenter 
suggested we add nasopharyngeal cancer. This malignancy will be 
evaluated under final listing 13.02, for soft tissue tumors of the head 
and neck. Another commenter suggested we add an adult listing for germ-
cell tumors. These malignancies will be evaluated under the criteria in 
listing 13.15B or listing 13.23E2, depending on the site of the 
malignancy.
    In other instances, such as prostate cancer with bone metastases or 
earlier stages of multiple myeloma, we believe that there are effective 
therapies that, even considering their length and effects, generally do 
not result in an impairment of listing-level severity. In these 
situations, we believe that the impairment should not be considered to 
be of listing-level severity until it is demonstrated that therapy is 
not effective.
    We did not add the other suggested additions, such as granulocytic 
sarcoma, because these malignancies are rare. As noted in sections 
13.00F and 113.00F of these rules, 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. The listings are

[[Page 67030]]

not intended to be all-inclusive. The purpose of the listings--to allow 
us to readily identify individuals with common impairments of listing-
level severity--would be defeated if we tried to identify every 
malignancy that could be of listing-level severity.
    However, we believe that our regulations do provide adequate 
guidance about how to evaluate malignancies that do not respond to 
treatment or that are unlisted. Many of these final listings address 
situations in which treatment is not successful. For example, final 
listing 13.02B addresses the situation in which the malignancy is 
persistent following initial multimodal antineoplastic treatment and 
final listing 13.09B addresses the situation in which the malignancy is 
progressive despite radioactive iodine therapy. We also have other 
rules that discuss how to evaluate impairments that are not listed. 
These other rules are not included in this notice, as we are not making 
any changes to them. We believe that malignancies that are not listed 
can be properly and uniformly evaluated under these other rules.
    Also, and as we have already noted, as we reviewed our proposed 
listings to respond to the last comment, we realized that we need to 
consider further how to include childhood malignant solid tumors in our 
listings. In the interim, we have decided to retain our prior criteria 
for these impairments.
    Comment: One commenter recommended that all cases of lymphoma 
should be determined to be of listing-level severity and that cases not 
covered by the proposed rules should be allowed with a short 
reexamination diary.
    Response: We have not included criteria for additional lymphoma 
cases. It would not be appropriate to include lymphomas that do not 
satisfy the criteria in these final rules because we cannot presume 
that these impairments will meet the statutory duration requirement. 
Other lymphomas may respond more readily to therapy.

Use Staging Systems

    Comment: Two commenters suggested we incorporate accepted 
classifications and staging in the listings. One indicated we should 
use clinical classifications and stagings that are tied to ongoing 
tumor registries that are matched with survival rates.
    Response: As in the NPRM, these final rules incorporate staging 
criteria where appropriate. In these instances, we list the criteria 
for the stage rather than refer to the stage number. For example, the 
criteria in final listing 13.10A, for locally advanced breast 
carcinoma, correspond to stage IIIB.
    We decided not to include staging numbers for two reasons. The 
first is that there are different staging classifications and these 
different classifications are not necessarily consistent. The second is 
that staging classifications change. If we used the staging number as 
the criterion, these rules may no longer be appropriate if a change in 
staging classifications is made.

Listings With Time Limits

    Comment: Several commenters noted that several of the proposed 
listings included language about time limits after which the 
adjudicator was advised to evaluate any residual impairment(s) under 
the relevant body system, but that these listings did not refer to the 
medical improvement review standard in Sec. Sec.  404.1594, 416.994, 
and 416.994a. They believed that failure to apply the medical 
improvement review standard at the end of the specified period would be 
contrary to the statute. One of these commenters believed that a time 
limit should, at most, result in a date for reviewing the individual's 
continuing eligibility for disability benefits.
    Response: As in the prior listings and in a number of listings in 
other body systems, some of the listings in these final rules contain 
time limits in their criteria to explain the period for which we will 
presume that the individuals are disabled based on the nature of their 
impairments, the duration and effects of therapy, and the expected 
course of the impairments. After the therapy is completed and the 
relevant time period has passed, we can no longer presume that these 
individuals are disabled. When we review these claims to determine if 
these individuals continue to be disabled, we will apply the 
appropriate medical improvement review standard set forth in our 
regulations in Sec. Sec.  404.1594, 416.994, or 416.994a.

Final Listing 13.02

    Comment: One commenter noted that we replaced the phrase ``not 
controlled by prescribed therapy'' in prior listing 13.02B with 
``[p]ersistent disease following initial multimodal antineoplastic 
therapy'' in proposed listing 13.02B. The commenter expressed concern 
that this criterion would exclude patients who are treated with 
radiation alone (uni-modal therapy), have persistent disease, and who 
cannot undergo surgery because of the medical condition or because the 
tumor remains unresectable. The commenter indicated the prognosis for 
these individuals seems to fit the intent of the listing. The commenter 
recommended we use the phrase ``therapy for curative intent'' instead 
of ``initial multimodal antineoplastic therapy.''
    Response: We did not adopt the comment because individuals 
described in the comment have impairments that meet final listing 
13.02A. That listing describes individuals who have tumors that are 
inoperable or unresectable. The definitions of the terms ``inoperable'' 
and ``unresectable'' in final 13.00I1 and 13.00I2 include the 
individuals described by the commenter.
    Comment: One commenter noted the criterion for epidermoid carcinoma 
occurring in the pyriform sinus in proposed listing 13.02E and 
questioned why this site was singled out. The commenter indicated this 
impairment would be covered under the criteria for soft tissue tumors 
with multimodal therapy in proposed listing 13.02F.
    Response: We agree with the commenter and have deleted the 
criterion for epidermoid carcinoma occurring in the pyriform sinus in 
final listing 13.02. Due to this deletion, we redesignated proposed 
listing 13.02F, for soft tissue tumors of the head and neck treated 
with multimodal therapy, as final listing 13.02E.

Final Listing 13.05

    Comment: One commenter believed that the language in proposed 
listing 13.05A2, for low-grade or indolent lymphoma requiring 
initiation of more than 1 antineoplastic treatment regimen within a 
consecutive 12-month period, was confusing. The commenter indicated 
that we should specify that concurrent treatments would not apply and 
that the treatments must occur on separate occasions.
    Response: The listing refers to a treatment regimen that may 
consist of more than one modality of treatment. The modalities used in 
the treatment regimen may be administered concurrently or sequentially, 
depending on the regimen. Regardless of the way the modalities are 
administered, they are still considered to be one treatment regimen. 
Therefore, we have not adopted the commenter's suggested changes.
    However, in reviewing the proposed listing in response to this 
comment, we realized that some clarification of the introductory text 
to the listings was needed. The heading of final listing 13.05 cross-
refers to 13.00K1 in the introductory text. However, proposed 13.00K1a 
discussed only ``indolent'' lymphoma, and did not refer to ``low 
grade'' lymphoma even though the

[[Page 67031]]

listing refers to both. This was an oversight. To be consistent with 
the listing criteria, we have amended final 13.00K1a to refer to both 
low grade and indolent lymphomas.

Final Listing 13.10

    Comment: One commenter noted the criterion for breast cancer in 
proposed listing 13.10C, for recurrent carcinoma, except local 
recurrence that remits with antineoplastic therapy. The commenter 
believed that this criterion should be interpreted to mean a recurrence 
that remits with therapy subsequent to initial treatment and that 
adjudicators would therefore be looking at two separate events. The 
commenter asked whether this interpretation was correct.
    Response: The commenter's interpretation is correct. Breast 
carcinoma that had previously remitted with initial antineoplastic 
treatment, that has now recurred locally, and that remits with the 
antineoplastic therapy given for the recurrence does not represent an 
impairment of listing-level severity. An example is breast cancer that 
initially remits following a lumpectomy and radiation, but later recurs 
at the site of the incision, and is successfully treated with 
mastectomy.

Final Listing 13.12

    Comment: One commenter noted that the phrase ``or with regional or 
distant metastases'' in proposed listing 13.12B was unnecessary as 
regional and distant metastases are covered in proposed listing 13.12A.
    Response: We agree with the commenter and have removed the phrase 
from final listing 13.12B.

Final Listing 13.13

    Comment: One commenter questioned why we retained the listing for 
metastatic carcinoma to the brain (proposed listings 13.13C and 
113.13C) when all other listings refer to the site of origin of the 
tumor. The commenter asked if these listings apply to cases of 
testicular cancer with brain metastases.
    Response: In response to this comment, we did not incorporate 
proposed listings 13.13C and 113.13C, for metastatic carcinoma to brain 
or spinal cord, in the final rules so that the final listings will 
refer to the site of origin of the tumor. We also revised the 
introductory text (13.00C and 113.00C) to reflect this change.

Final Listing 13.14

    Comment: One commenter disagreed with the proposed deletion of the 
listing for non-squamous non-small-cell carcinoma with metastases to 
the hilar lymph nodes (prior listing 13.13E). The commenter indicated 
that there have not been significant treatment advances for this 
malignancy, nor has there been a significant improvement in prognosis. 
The commenter stated that excising the involved hilar nodes has not 
altered the unfavorable prognosis for this malignancy.
    Response: We agree with the commenter and have revised listing 
13.14A to include the hilar nodes.

Final Listing 13.25

    Comment: One commenter objected to the deletion of prior listing 
13.24A, for choriocarcinoma. The commenter indicated that 
choriocarcinoma is a particularly aggressive testicular cancer with 
frequent distant metastases and should not be evaluated in the same 
manner as other forms of testicular cancer.
    Response: The literature we consulted did not separate 
choriocarcinoma from other forms of testicular nonseminomatous germ-
cell tumors with regard to staging or treatment. Therefore, we did not 
adopt the comment.

Final Listing 113.10

    Comment: One commenter questioned the proposed deletion of the 
criterion for bilateral retinoblastoma (prior listing 113.05A). The 
commenter indicated that most children with this disease are blind in 
one eye and have decreased vision in the other eye, resulting in 
significant visual impairments.
    Response: We recognize that the current treatment of this disease 
results in significant visual impairments. While we have not retained 
this criterion in final listing 113.10, we have added guidance to the 
introductory text, final 113.00K5, providing that we will evaluate any 
resulting visual impairment(s) under the criteria in listing 102.02.

Final Listing 113.21

    Comment: One commenter noted that prior listing 113.04, for 
neuroblastoma, included a criterion for recurrent disease which was not 
included in proposed listing 113.21A. The commenter asked if we 
intended to delete this criterion, as the deletion was not addressed in 
the explanation of the proposed listing.
    Response: We did not intend to delete this criterion, and it is 
included in these rules as final listing 113.21C.

Final Listings 113.25 and 113.26

    Comment: Two commenters noted that testicular germ-cell tumors 
could be evaluated under either proposed listing 113.25, for testicular 
malignancies, or proposed listing 113.26, for germ-cell tumors. The 
commenters suggested that we evaluate testicular germ-cell tumors under 
the listing for testicular malignancies and exclude them from the 
listing for germ-cell tumors.
    Response: We did not adopt the comments because we decided to 
retain our prior criteria for malignant solid tumors in children. Under 
these final rules, malignant neoplasms that would have been evaluated 
under the proposed listings 113.25 and 113.26 will be considered to be 
disabling for 2 years from the date of initial diagnosis or the date of 
recurrence of active disease.

Final Listing 113.28

    Comment: One commenter believed that a 12-month listing criterion 
is too short for children who have malignant neoplastic diseases 
treated by allogeneic bone marrow or stem cell transplantation. The 
commenter believed we should consider the increased risk of acute or 
chronic graft vs. host disease and infection in pediatric patients.
    Response: As already noted, we decided to retain our prior criteria 
for malignant solid tumors in children. Therefore, we are not including 
the proposed listing that was the subject of this comment in these 
final rules.
    Under these final rules, criteria for evaluating bone marrow or 
stem cell transplants in cases of leukemia or lymphoma are included in 
the listings for those disorders, final listings 113.05 and 113.06. 
Under final listing 113.03, malignant solid tumors in children will be 
considered disabling for 2 years from the date of initial diagnosis or 
the date of recurrence of active disease regardless of whether a bone 
marrow or stem cell transplant has been performed. The adult listing 
for bone marrow or stem cell transplantation, final listing 13.28, can 
be used to evaluate those few cases in which the end of the 2-year 
period is earlier than the end of the period that the impairment would 
be considered disabling based on the bone marrow or stem cell 
transplantation. Final listing 13.28A, for malignant neoplastic 
diseases treated by allogeneic bone marrow or stem cell 
transplantation, provides that the individual will be considered to be 
under a disability until ``at least'' 12 months from the date of 
transplantation. Use of the phrase ``at least'' provides us with the 
flexibility to set a longer time frame when appropriate.

[[Page 67032]]

Regulatory Procedures

Executive Order 12866

    We have consulted with the Office of Management and Budget (OMB) 
and determined that these final rules meet the criteria for a 
significant regulatory action under Executive Order 12866, as amended 
by Executive Order 13258. Thus, they were subject to OMB review.

Regulatory Flexibility Act

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

Paperwork Reduction Act

    These final rules contain reporting requirements at 13.00B, 13.00D, 
13.00E, 13.00G, 13.00K, 113.00B, 113.00D, 113.00E, 113.00G, and 113.00K 
of the final rules. An Information Collection Request has been 
submitted to OMB. While these rules will be effective 30 days from 
publication, these burdens will not be effective until approved by OMB. 
We will publish a notice in the Federal Register upon OMB's approval of 
the information collection requirements.

List of Subjects in 20 CFR Part 404

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


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

    Dated: July 19, 2004.
Jo Anne B. Barnhart,
Commissioner of Social Security.


0
For the reasons set forth in the preamble, subpart P of part 404 of 
chapter III of title 20 of the Code of Federal Regulations is amended 
as set forth below:

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

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

    Authority: Secs. 202, 205(a), (b), and (d)-(h), 216(i), 221(a) 
and (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]

0
2. Appendix 1 to subpart P of part 404 is amended as follows:
0
a. Item 8 of the introductory text before part A of appendix 1 is 
amended by revising the body system name.
0
b. Item 14 of the introductory text before part A of appendix 1 is 
amended by revising the body system name and expiration date.
0
c. The Table of Contents for part A of appendix 1 is amended by 
revising the body system names for sections 7.00 and 13.00.
0
d. The body system name of section 7.00 of part A of appendix 1 is 
revised and paragraph E of the introductory text of section 7.00, 
Hematological Disorders, is removed.
0
e. Listings 7.11, 7.12, 7.13, 7.14, and 7.16 of part A of appendix 1 
are removed.
0
f. Listing 7.17 of part A of appendix 1 is revised.
0
g. Paragraph B of the introductory text of section 11.00, Neurological, 
of part A of appendix 1 is revised.
0
h. Listing 11.05 of part A of appendix 1 is revised.
0
i. Section 13.00 of part A of appendix 1 is revised.
0
j. The Table of Contents for part B of appendix 1 is amended by 
revising the body system names for sections 107.00 and 113.00.
0
k. The body system name of section 107.00 of part B of appendix 1 is 
revised and paragraph C of the introductory text of section 107.00, 
Hematological Disorders, is removed.
0
l. Listing 107.11 of part B of appendix 1 is removed.
0
m. Paragraph E is added to the introductory text of section 111.00, 
Neurological, of part B of appendix 1.
0
n. Listing 111.05 of part B of appendix 1 is revised.
0
o. Section 113.00 of part B of appendix 1 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): July 1, 2005.
* * * * *
    14. Malignant Neoplastic Diseases (13.00 and 113.00): December 
15, 2009.
* * * * *

Part A

* * * * *
    7.00 Hematological Disorders
* * * * *
    13.00 Malignant Neoplastic Diseases
* * * * *
    7.00 HEMATOLOGICAL DISORDERS
* * * * *
    E. [removed]
* * * * *
    7.11 [removed]
    7.12 [removed]
    7.13 [removed]
    7.14 [removed]
* * * * *
    7.16 [removed]
    7.17 Aplastic anemias with bone marrow or stem cell 
transplantation. Consider under a disability for 12 months following 
transplantation; thereafter, evaluate according to the primary 
characteristics of the residual impairment.
* * * * *
    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, 11.04, 
or the criteria of the affected body system.
* * * * *
    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 if you also have 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? 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 generally 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

[[Page 67033]]

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 your 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, the failure will often happen within 6 months after 
the treatment 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 you from doing 
any gainful activity. If your severe impairment(s) does not meet the 
criteria of any of these listings, we must also consider whether you 
have an impairment(s) that meets the criteria of a listing in 
another body system.
    2. If you have a severe medically determinable impairment(s) 
that does not meet a listing, we will determine whether your 
impairment(s) medically equals a listing. (See Sec. Sec.  404.1526 
and 416.926.) If your impairment(s) does not meet or medically equal 
a listing, you may or may not have the residual functional capacity 
to engage in substantial gainful activity. In that situation, we 
proceed to the fourth, and, if necessary, the fifth steps of the 
sequential evaluation process in Sec. Sec.  404.1520 and 416.920. If 
you are an adult, we use the rules in Sec. Sec.  404.1594 and 
416.994, as appropriate, when we decide whether you continue to be 
disabled.
    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 
these 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 a listing, we must 
consider its effect on your ability to do substantial gainful 
activity.
    H. How long do we consider your impairment to be disabling?
    1. In some listings, we specify that we will consider your 
impairment to be disabling until a particular point in time (for 
example, at least 18 months from the date of diagnosis). We may 
consider your impairment to be disabling beyond this point when the 
medical and other evidence justifies it.
    2. When a listing does not contain such a specification, we will 
consider an impairment(s) that meets or medically equals a listing 
in this body system to be disabling until at least 3 years after 
onset of complete remission. When the impairment(s) has been in 
complete remission for at least 3 years, that is, the original tumor 
and any metastases have not been evident for at least 3 years, the 
impairment(s) will no longer meet or medically equal the criteria of 
a listing in this body system.
    3. Following the appropriate period, we will consider any 
residuals, including residuals of the malignancy or therapy (see 
13.00G), in determining whether you are disabled.
    I. What do these terms in the listings mean?
    1. Inoperable: Surgery is thought to be of no therapeutic value 
or the surgery cannot 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. The determination 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, relapse: 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. Your symptoms.
    K. How do we evaluate specific malignant neoplastic diseases?
    1. Lymphoma.
    a. Many low grade or indolent (non-aggressive) lymphomas are 
controlled by well-tolerated treatment modalities, although they may 
produce intermittent symptoms and signs. Therefore, we may defer 
adjudication of these cases for an appropriate period after 
initiation of therapy to determine whether the therapy will achieve 
its intended effect. (See 13.00E3.) For a low grade or indolent 
lymphoma, the intended effect of therapy is usually stability of the 
disease process. When stability has been achieved, we will assess 
severity on the basis of the extent of involvement of other organ 
systems and residuals from therapy.
    b. A change in therapy for low grade or indolent lymphomas is 
usually an indicator that the therapy is not achieving its intended 
effect. However, it does not indicate this if the change is based on 
your (or your physician's) choice rather than a failure to achieve 
stability. If the therapy is changed

[[Page 67034]]

due solely to choice, the requirements of listing 13.05A2a 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/mm \3\ for 3 months or longer, or other acceptable diagnostic 
techniques consistent with the prevailing state of medical knowledge 
and clinical practice.
    ii. We evaluate the complications and residual impairment(s) 
from CLL under the appropriate listings, such as 13.05A2, 7.02, and 
7.15.
    d. Elevated white cell count. 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 7.02, 7.06, 7.08, or 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. If you undergo bone marrow or 
stem cell transplantation for any of these disorders, we will 
consider you to be 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. If you 
undergo bone marrow or stem cell transplantation for any of these 
disorders, we will consider you to be 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 will 
consider you to be disabled depends on whether you undergo 
allogeneic or autologous transplantation.
    a. Allogeneic bone marrow or stem cell transplantation. If you 
undergo allogeneic transplantation (transplantation from an 
unrelated donor or a related donor other than an identical twin), we 
will consider you to be disabled until at least 12 months from the 
date of transplantation.
    b. Autologous bone marrow or stem cell transplantation. If you 
undergo autologous transplantation (transplantation of your own 
cells or cells from your identical twin (syngeneic 
transplantation)), we will consider you to be 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 you 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

    D. With metastases beyond the regional lymph nodes.

OR

    E. Soft tissue tumors of the head and neck not addressed in A-D, 
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. Recurrent 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 13.00K1 and 13.00K2c.)
    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 one antineoplastic treatment regimen within a consecutive 12-
month period. Consider under a disability from at least 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 13.00K2.)
    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:

[[Page 67035]]

    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).
    A. Failure to respond or progressive disease following initial 
antineoplastic therapy.

OR

    B. 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.
    13.08 Salivary glands--carcinoma or sarcoma with metastases 
beyond the regional lymph 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 13.00K4.)
    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 temporal 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

    C. Tumors with extension to the base of the skull, orbit, 
meninges, or sinuses.
    13.13 Nervous system. (See 13.00K6.)
    A. Central nervous system neoplasms (brain and spinal cord), as 
described in 1 or 2:
    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 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.
    13.14 Lungs.
    A. Non-small-cell carcinoma--inoperable, unresectable, 
recurrent, or metastatic disease to or beyond the hilar 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. With metastases to or beyond the regional lymph nodes.
    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 or beyond the regional lymph nodes.
    13.22 Urinary bladder--carcinoma.
    A. With infiltration beyond the bladder wall.

OR

    B. Recurrent after total cystectomy.

OR

    C. Inoperable or unresectable.

OR

    D. With 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 tubes, 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. Recurrent 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.


[[Page 67036]]


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.
* * * * *

Part B

* * * * *
    107.00 Hematological Disorders
* * * * *
    113.00 Malignant Neoplastic Diseases
* * * * *
    107.00 HEMATOLOGICAL DISORDERS
* * * * *
    C. [removed]
* * * * *
    107.11 [removed]
* * * * *
    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 111.02, 111.03, 
111.06, 111.09 or the criteria of the affected body system.
* * * * *
    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 114.08E to evaluate carcinoma of 
the cervix, Kaposi's sarcoma, lymphoma, and squamous cell carcinoma 
of the anus if you also have 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? 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. In the rare 
situation in which the primary site cannot be identified, we will 
use evidence documenting the site(s) of metastasis to evaluate the 
impairment under 13.27 in part A.
    2. For operative procedures, including a biopsy or a needle 
aspiration, we generally 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 your 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, the failure will often happen within 6 months after 
treatment 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 your impairment(s) does not meet 
the criteria of any of these listings, we must also consider whether 
you have an impairment(s) that meets the criteria of a listing in 
another body system.
    2. If you have a severe medically determinable impairment(s) 
that does not meet a listing, we will determine whether your 
impairment(s) medically equals a listing. (See Sec. Sec.  404.1526 
and 416.926.) If it does not, we will also consider whether you have 
an impairment(s) that functionally equals the listings. (See Sec.  
416.926a.) We use the rules in Sec.  416.994a when we decide whether 
you continue to be disabled.
    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 
these 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 a listing, or, as appropriate, 
functionally equals the listings.
    H. How long do we consider your impairment to be disabling?
    1. In some listings, we specify that we will consider your 
impairment to be disabling until a particular point in time (for 
example, at least 12 months from the date of diagnosis). We may 
consider your impairment to be disabling beyond this point

[[Page 67037]]

when the medical and other evidence justifies it.
    2. When a listing does not contain such a specification, we will 
consider an impairment(s) that meets or medically equals a listing 
in this body system to be disabling until at least 3 years after 
onset of complete remission. When the impairment(s) has been in 
complete remission for at least 3 years, that is, the original tumor 
and any metastases have not been evident for at least 3 years, the 
impairment(s) will no longer meet or equal the criteria of a listing 
in this body system.
    3. Following the appropriate period, we will consider any 
residuals, including residuals of the malignancy or therapy (see 
113.00G), in determining whether you are disabled.
    I. What do these terms in the listings mean?
    1. Persistent: Failure to achieve a complete remission.
    2. Progressive: The malignancy became more extensive after 
treatment.
    3. Recurrent, relapse: 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. Your 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 low grade or indolent lymphomas 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. (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 that is 
aggressive and clinically similar to acute myelogenous leukemia. We 
evaluate JCML under 113.06A.
    d. Elevated white cell count. 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. Malignant solid tumors. The tumors we consider under 113.03 
include the histiocytosis syndromes except for solitary eosinophilic 
granuloma. Therefore, we will not evaluate brain tumors (see 113.13) 
or thyroid tumors (see 113.09) under this listing.
    4. 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.
    5. Retinoblastoma. The treatment for bilateral retinoblastoma 
usually results in a visual impairment. We will evaluate any 
resulting visual impairment under 102.02.
    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. If you undergo bone 
marrow or stem cell transplantation for any of these disorders, we 
will consider you to be 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. If you undergo bone marrow 
or stem cell transplantation for any of these disorders, we will 
consider you to be disabled until at least 12 months from the date 
of transplantation.
    3. 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

    113.03 Malignant solid tumors. Consider under a disability:
    A. For 2 years from the date of initial diagnosis. Thereafter, 
evaluate any residual impairment(s) under the criteria for the 
affected body system.

OR

    B. For 2 years from the date of recurrence of active disease. 
Thereafter, evaluate any residual impairment(s) under the criteria 
for the affected body system.
    113.05 Lymphoma (excluding T-cell lymphoblastic lymphoma--
113.06). (See 113.00K1.)
    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 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 of the affected body system.
    113.06 Leukemia. (See 113.00K2.)
    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.
    113.12 Retinoblastoma.
    A. With extension beyond the orbit.

OR

    B. Persistent or recurrent following initial antineoplastic 
therapy.

OR

    C. With regional or distant metastases.
    113.13 Brain tumors. (See 113.00K4.) 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 sarcomas.
    113.21 Neuroblastoma.
    A. With extension across the midline.


[[Page 67038]]


OR

    B. With distant metastases.

OR

    C. Recurrent.

OR

    D. With onset at age 1 year or older.
* * * * *

[FR Doc. 04-24897 Filed 11-12-04; 8:45 am]
BILLING CODE 4191-02-P