[Federal Register: November 15, 2004 (Volume 69, Number 219)]
[Rules and Regulations]
[Page 67017-67038]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15no04-44]
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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
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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:
Workers insured under the Act.
Children of insured workers.
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:
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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 * * *
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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.
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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:
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.
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.
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:
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.
Clarifying that we consider biopsies and needle
aspirations to be ``operative procedures.''
Using the more general term ``pathology report'' instead
of ``the report of the gross and microscopic examination of the
surgical specimen.'' We 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:
Take into account medical advances in the detection,
treatment, control, and cure of malignant neoplastic diseases.
Recognize that in some situations the effects of therapy
for these disorders can be disabling.
Provide for the evaluation of residual impairments.
The following is a detailed explanation of the 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:
Redesignating the current listing as proposed listing
13.09.
Adding a separate criterion for anaplastic
(undifferentiated) carcinoma in proposed listing 13.09A.
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.
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:
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.
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.
Revising 11.00B to indicate that malignant brain tumors
should be evaluated under the criteria in listing 13.13.
Adding 111.00E to provide the same guidance as final
11.00B.
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.
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