Federal Register, Volume 80 Issue 97 (Wednesday, May 20, 2015)

[Federal Register Volume 80, Number 97 (Wednesday, May 20, 2015)]
[Rules and Regulations]
[Pages 28821-28832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11923]

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SOCIAL SECURITY ADMINISTRATION

20 CFR Part 404

[Docket No. SSA-2011-0098]
RIN 0960-AH43

Revised Medical Criteria for Evaluating Cancer (Malignant
Neoplastic Diseases)

AGENCY: Social Security Administration.

ACTION: Final rule.

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SUMMARY: We are revising the criteria in parts A and B of the Listing
of Impairments (listings) that we use to evaluate claims involving
cancer (malignant neoplastic diseases) under titles II and XVI of the
Social Security Act (Act). These revisions reflect our adjudicative
experience, advances in medical knowledge, recommendations from medical
experts we consulted, and public comments we received in response to a
Notice of Proposed Rulemaking (NPRM).

DATES: This rule is effective July 20, 2015.

[[Page 28822]]

FOR FURTHER INFORMATION CONTACT: Cheryl A. Williams, Office of Medical
Policy, Social Security Administration, 6401 Security Boulevard,
Baltimore, Maryland 21235-6401, (410) 965-1020. 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 site,
Social Security Online, at http://www.socialsecurity.gov.

SUPPLEMENTARY INFORMATION:

Background

We are revising and making final the regulations for evaluating
cancer (malignant neoplastic diseases) that we proposed in an NPRM
published in the Federal Register on December 17, 2013, at 78 FR 76508.
Even though this rule will not go into effect until 60 days after
publication of this document, for clarity we refer to it in this
preamble as the ``final'' rule. We refer to the rule in effect prior to
that time as the ``prior'' rule.
In the preamble to the NPRM, we discussed our proposed changes and
our reasons for making them. Since we are mostly adopting those
revisions as we proposed them, we are not repeating that information
here. Interested readers may refer to the preamble in the NPRM,
available at http://www.regulations.gov.
We are making some changes in this final rule based on the public
comments we received on the NPRM. We explain these changes in the
``Summary of Public Comments'' below.

Why are we revising the cancer listings?

We developed this final rule as part of our ongoing review of the
cancer body system. When we last revised the listings for this body
system in a final rule published on October 6, 2009, we indicated that
we would monitor and update the listings as needed.\1\
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\1\ See 74 FR 51229.
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How long will this final rule stay in effect?

We are extending the effective date of the cancer body system in
parts A and B of the listings until 5 years after the effective date of
this final rule. The rule will remain in effect only until that date
unless we extend the expiration date. We will continue to monitor the
rule and may revise it, as needed, before the end of the 5-year period.

Summary of Public Comments

In the NPRM, we gave the public a 60-day comment period that ended
on February 18, 2014. We received 15 comments. The commenters included
national cancer advocacy groups, State agencies, a national group
representing disability examiners in State agencies that make
disability determinations for us, medical professionals, and individual
members of the public.
We carefully considered all of the significant comments relevant to
this rulemaking. We have condensed and summarized the comments below.
We believe we have presented the commenters' concerns and suggestions
accurately and completely and responded to all significant issues that
were within the scope of this rule. We provide our reasons for adopting
or not adopting the recommendations in our responses below.

General Comments

Comment: Many commenters supported our proposal to change the name
of this body system from ``Malignant Neoplastic Diseases'' to
``Cancer'' to make the name more recognizable to the lay public.
However, some commenters believed this change was not necessary or
appropriate. These commenters believed the lay public is sufficiently
aware of the meaning of the term ``malignant neoplastic diseases'' and
that we should continue using it as the body system's name. One
commenter thought ``malignant neoplastic diseases'' is a more
encompassing name for the body system than ``cancer.'' The commenter
contended the term ``cancer'' has traditionally meant only carcinoma,
and does not include sarcoma, leukemia, or malignancies in other cell
types.
Response: We disagree with the commenters' view that the lay public
is sufficiently aware of the term ``malignant neoplastic diseases,''
and have adopted our proposal to change the name of this body system to
``Cancer.'' We believe the lay public understands that the term
``cancer'' means not only carcinoma but also the wide array of
malignancies. The National Cancer Institute (NCI), National Cancer
Society (NCS), and other recognized experts use the term ``cancer''
when referring to carcinoma, sarcoma, leukemia, lymphoma, and
malignancies of the central nervous system in their publications.\2\
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\2\ For example, see ``NCI Home'' at http://www.cancer.gov, and
``American Cancer Society Home'' at http://www.cancer.org/index.
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Comment: A commenter, who supported the proposed name change,
recommended that we use the term ``anticancer therapy'' instead of
``antineoplastic therapy'' in this final rule.
Response: We agree with the commenter and have modified the
listings accordingly.
Comment: One commenter suggested we have only one listing for
evaluating small-cell carcinomas rather than adopt our proposal to
provide a criterion for small-cell carcinoma under several, specific
listings.\3\
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\3\ We retained prior listing 13.14B for evaluating small-cell
carcinoma in the lungs and added a criterion for small-cell
carcinoma under the following specific listings: 13.02D for soft
tissue cancers of the head and neck; 13.10D for cancer of the
breast; 13.15C for cancer of the pleura and mediastinum; 13.16C for
cancer of the esophagus or stomach; 13.17C for cancer of the small
intestine; 13.18D for cancer of the large intestine; 13.22E for
cancer of the urinary bladder; 13.23F for cancers of the female
genital tract; and 13.24C for cancer of the prostate gland. We
include a listing for small-cell carcinoma of the small intestine,
even though it is a very rare cancer, to maintain internal
consistency among the regulations, and because of the cancer's
unfavorable prognosis.
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Response: We did not adopt the comment. Some small-cell carcinomas
might be included under the single listing the commenter proposed, but
may have favorable prognoses and not be of listing-level severity.
These small-cell carcinomas have a favorable prognosis because
physicians can detect them in their early stages when it is still
possible to remove the cancer. The final listings cover small-cell
carcinomas that occur in certain organs and tissues where physicians
are unlikely to detect them in their early stages, and treatment is
mainly palliative.
Comment: One commenter suggested that we include the stage of the
cancer in the final listings for evaluating central nervous system and
cervical cancers, and lymphomas.
Response: We did not adopt the comment for two reasons. First, the
cancers mentioned by the commenter may have different staging systems
that are inconsistent with each other. Second, staging systems could
change, potentially resulting in an inability to find people with
listing-level impairments disabled at the listing step of the
sequential evaluation process.
Comment: A commenter proposed we provide more guidance in part B
for evaluating conditions in children, resulting from cancer or its
treatment, that do not meet the listings. The commenter said such
conditions might include organ dysfunction resulting from small-cell
carcinomas, or secondary lymphedema resulting from breast cancer
treatment. The commenter believed the additional guidance would make
the final listings more comprehensive.
Response: We did not adopt the comment because we believe final
sections 113.00F and 113.00G already

[[Page 28823]]

provide the type of guidance the commenter recommended. In these
sections, we explain that if a child has a medically determinable
impairment that does not meet the listings, we will determine whether
the impairment medically equals the listings. This determination would
include impairments caused by the cancer or treatment side effects. If
the impairment does not medically equal a listing, section 113.00F
further explains that we will also determine whether the impairment
functionally equals the listings. Again, this determination would
include impairments caused by the cancer or treatment side effects.
Comment: One commenter recommended we provide more guidance for
evaluating treatment failure in bone marrow and stem cell
transplantation, and proposed specific language for making this change.
Response: We believe the change, and the specific language the
commenter proposed, is not necessary because listings for bone marrow
and stem cell transplantation have a criterion for evaluating any
residual impairments following treatment. These residual impairments
would include the evaluation of those associated with treatment
failure.

Section 13.00E--When do we need longitudinal evidence?

Comment: One commenter asked us to specify which sources can
provide the evidence required in final section 13.00E3c to document
that the treating source has started multimodal therapy under final
listings 13.02E, 13.11D, and 13.14C. The commenter indicated that we
should accept this evidence only from an acceptable medical source such
as a medical or osteopathic doctor.
Response: We did not adopt the comment because it may limit our
ability to obtain evidence to determine if multimodal therapy has
started and, thus, establish listing-level severity. While an
acceptable medical source may provide this evidence, our existing
policy allows us to accept evidence from other medical sources to
establish the impairment's severity.\4\ For example, this evidence may
come from sources we do not consider acceptable medical sources, such
as oncology nurse practitioners who administer chemotherapy and
radiation therapists who deliver radiation treatments.
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\4\ See 20 CFR 404.1513(d) and 416.913(d).
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Sections 13.00I and 113.00I--What do we mean by the following terms?

Comment: One commenter expressed concern over proposed sections
13.00I6 and 113.00I5, in which we clarified that we consider a cancer
to be ``progressive'' if it is still growing after the person has
completed at least half of his or her planned initial anticancer
therapy. The commenter believed this criterion might delay adjudication
if the adjudicator must contact the treating source to ask how much of
planned treatment the person has completed.
Response: We did not adopt this comment. We disagree with the
commenter because we do not expect adjudicators to obtain more
information than we required under the prior regulations. The proposed
and final sections express our intent to decide as quickly as possible
that a person is disabled.
Comment: The same commenter thought that the definition of the term
``progressive'' could result in a finding that the claimant has a
condition medically equivalent to cancer listings that do not require
the malignancy to be progressive.
Response: We do not share the commenter's concern because, as we
explain in sections 13.00C and 113.00C, we will only apply the criteria
in a specific listing to a cancer originating from that specific site.
Comment: One commenter recommended that we revise the definition of
``persistent'' cancer in final section 13.00I5. The commenter also
provided language for the suggested revision.
Response: We did not adopt the comment for two reasons. First, the
language the commenter proposed could be misinterpreted to require that
all of a person's anticancer therapy must fail to achieve a complete
remission, including any second- or third-line therapies after initial
anticancer therapy.\5\ This interpretation would be contrary to our
intent in listings that require only the planned initial anticancer
therapy to fail. Second, the language the commenter proposed would not
explain the meaning of the phrase ``failed to achieve a complete
remission.'' By defining this phrase, the final section clarifies that
the cancer is ``persistent'' if any of it remains after treatment is
completed, even if the cancer responded to the initial therapy and
became smaller.
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\5\ We may consider follow-up surgery to be a part of initial
anticancer treatment if the intent of the follow-up surgery is to
obtain clear margins and the complete eradication of any residual
cancer left behind.
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Comment: One commenter recommended that the definition of the term
``unresectable'' in final section 13.00I8 address the presence of
micrometastases. The commenter contended that ``unresectable'' should
not include situations in which the surgeon removed the tumor and then
used adjuvant therapy to eliminate any micrometastases.
Response: We did not adopt the comment. We believe the commenter's
proposed change is unnecessary. Final section 13.00I8 defines
``adjuvant therapy'' as anticancer therapy given after surgery ``to
eliminate any remaining cancer cells or lessen the chance of
recurrence.'' These ``remaining cancer cells'' include micrometastases.

Sections 13.00K and 113.00K--How do we evaluate specific cancers?

Comment: A commenter recommended that we add examples of common
indolent lymphomas in final section 13.00K1a. The commenter also
recommended that we add examples of common solid tumors in final
section 113.00K3.
Response: We did not adopt the comment. These recommendations
appear to be administrative concerns better handled through training
and operating instructions for our adjudicators.
Comment: A commenter recommended that we create a listing for
primary peritoneal carcinoma. The commenter argued that having a
listing would be better than the guidance in section 13.00K7, in which
we explained that we can evaluate this cancer in women under final
13.23E for ovarian cancer, and evaluate it in men under 13.15A for
malignant mesothelioma.
Response: We did not adopt the commenter's recommendation that we
create a listing for primary peritoneal carcinoma. Primary peritoneal
carcinoma is very rare, and we do not usually provide listings for rare
cancers. Instead, we believe the better practice is to clarify in the
introductory text which listings to use to evaluate certain rare
cancers, as we did in final section 13.00K7 for primary peritoneal
carcinoma.
Comment: A few commenters expressed concern about the clarification
in proposed section 13.00K8 that excludes ``biochemical recurrence''
for evaluating recurrent cancer of the prostate gland in listing
13.24A. In this section, we defined ``biochemical recurrence'' as an
increase in the serum prostate-specific antigen (PSA) level following
the completion of anticancer therapy. Section 13.24A requires
corroborating evidence to document recurrence, such as radiological
studies or findings on physical exam. Commenters believed this
requirement might delay a finding

[[Page 28824]]

of disability and unfairly penalize people with prostate cancer. They
noted that doctors frequently use PSA values to determine recurrence
and may initiate anticancer treatment for recurrent cancer upon this
evidence alone.
Response: We agree that in some cases, an isolated PSA reading may
support a diagnosis of recurrent prostate cancer, especially if this
diagnosis is from an acceptable medical source and is consistent with
the prevailing state of medical knowledge and clinical practice.
However, we did not adopt the comments because we believe it is
reasonable to require corroborating evidence to confirm the diagnosis.
A rising PSA level alone does not necessarily mean prostate cancer has
returned. Additional factors, such as the cancer's TNM \6\
characteristics, PSA kinetics, timing of the biochemical recurrence,
treatment modality, and Gleason score, should be
considered.^{7 8} The American Joint Committee on Cancer notes
that the natural progression from biochemical recurrence to clinical
disease recurrence is highly variable and may depend on these
additional factors.\9\ In light of this variability and the other
factors that should be considered, we continue to believe that we
should exclude ``biochemical recurrence'' in listing 13.24A.
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\6\ The acronym ``TNM'' relates to the Tumor size, lymph Node
involvement, and presence of Metastases.
\7\ PSA kinetics involves assessing the PSA level over time,
such as measuring of its rate of change (velocity) and how long it
takes it to double.
\8\ The National Cancer Institute defines ``Gleason score'' as a
system of grading prostate cancer tissue based on how it looks under
the microscope (available at: http://www.cancer.gov/dictionary?CdrID=45696).
\9\ See Carolyn C. Compton et al. eds., Cancer Staging Atlas: A
Companion to the Seventh Editions of the AJCC Cancer Staging Manual
and Handbook, New York: Springer, 2012, page 535-545.
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Comment: One commenter recommended that we delete the parenthetical
reference to ``benign melanocytic tumor'' in final sections 13.00K9 and
113.00K6. The commenter claimed that citing a benign disease in the
cancer listings may be confusing for adjudicators.
Response: We did not adopt the comment because we believe the
reference to benign melanocytic tumor can direct adjudicators to the
appropriate body systems for evaluating this condition, Skin Disorders
(8.00 and 108.00). This reference is similar to how final sections
13.00K6c and 113.00K4c direct adjudicators to the appropriate body
systems for evaluating benign brain tumors.

Listing 13.02--Soft Tissue Cancers of the Head and Neck (Except
Salivary Glands--13.08--and Thyroid Gland--13.09)

Comment: A commenter recommended revisions to 13.02E to condense
the final listing significantly.
Response: We did not adopt the comment because the proposed change
might be misinterpreted to include any metastases in the head or neck
from cancers originating elsewhere under listing 13.02E. Our intent in
this listing is to evaluate cancers that receive multimodal therapy and
originate in the head and neck only.

Listing 113.05--Lymphoma (Excluding All Types of Lymphoblastic
Lymphomas--113.06)

Comment: A commenter recommended that we include cerebrospinal
fluid (CSF) findings as evidence for determining listing-level lymphoma
under final listings 113.05A1 and 113.05B1.
Response: We did not adopt the comment. It is not a standard
clinical practice in lymphoma to conduct cerebrospinal fluid
examination for analysis; therefore, we do not believe it is
appropriate to require this evidence to establish severity. However, we
will inform adjudicators, through training and operating instructions,
that they can accept CSF findings if this evidence is available.

Listing 13.10--Breast (Except Sarcoma--13.04)

Comment: One commenter asked how long adjudicators should defer
adjudication of cases for evaluating breast cancer with secondary
lymphedema resulting from anticancer therapy and treated by surgery to
salvage or restore the functioning of an upper extremity under proposed
listing 13.10E.
Response: We disagree with the commenter's premise that
adjudicators need to defer adjudication of these cases. Adjudicators
can adjudicate a case at the listing step if the surgery is performed.
The need for this surgery to salvage or restore functioning of an upper
extremity demonstrates listing-level severity of the secondary
lymphedema without the need to make a determination about the
effectiveness of the surgery.
Comment: A commenter recommended we add a listing that prescribes a
period of disability of at least 18 months for people receiving
multimodal therapy for breast cancer. The commenter noted that
multimodal therapy could last 6 or more months and produce very serious
adverse effects. The commenter also noted that it is common for us to
find these people disabled after the listing step in the sequential
evaluation process by taking into consideration the adverse effects of
treatment and that the length of treatment nearly satisfies the 12-
month duration requirement. The commenter believed it would be better
for us to make the determination of disability at the listing step.
Similarly, a commenter recommended we add a listing that prescribes
a period of disability of at least 18 months for people receiving
multimodal therapy that includes surgery for low anal cancers and
rectal cancers. The commenter noted that neoadjuvant chemotherapy or
radiation followed by surgery to eliminate these anal or rectal cancers
frequently takes at least 12 months to complete. The treatment may
result in prolonged debilitation although the impairment may not meet
or medically equal the listings.
Response: We believe the commenter's proposed listing for breast
cancer would cover many cases of early cancer. Most people with early
breast cancer complete multimodal therapy within 6 months and recover
from any adverse effects relatively soon. In these cases, the
impairment would not preclude the ability to work for the required 12
months.
However, we agree with the commenter that in some cases multimodal
therapy may take substantially longer than 6 months to complete. For
example, very serious adverse effects may interrupt and prolong
therapy, resulting in an active impairment lasting almost 12 months. It
is a long-standing principle that we may make a finding of disability
at the listing step if there is the expectation that an impairment that
has been active for almost 12 months will preclude a person from
engaging in any gainful activity for the required 12 months. We base
this finding on the nature of the impairment; prescribed treatment;
therapeutic history, including adverse effects of treatment; and other
relevant considerations. Therefore, we partially adopted the comment by
providing language in final section 13.00G3 to clarify that we can
apply this principle to multimodal anticancer therapy for breast cancer
and other cancers. We also added the clarifying language in final
section 113.00G3 for children.
We did not make changes to listing 13.18 for evaluating anal and
rectal cancers. This listing and the commenter's recommendation for a
new listing covering multimodal therapy with surgery for anal and
rectal cancers

[[Page 28825]]

are outside the scope of this rulemaking. However, we believe the
changes made in final section 13.00G3 partially address this
commenter's concerns.

Listing 13.13--Nervous System

Comment: One commenter recommended that we clarify in the
introductory text whether adjudicators should use listing 13.13 to
evaluate pituitary gland cancer in adults.
Response: We adopted the commenter's recommendation by providing
language in final section 13.00K6a and final section 113.00K4a in the
introductory text clarifying that we evaluate cancerous pituitary gland
tumors, for example, pituitary carcinoma,\10\ under final listing
13.13A1 and final listing 113.13A, respectively.
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\10\ Pituitary gland carcinoma is highly malignant. Treatment is
mainly palliative. People who have pituitary gland carcinoma have a
mean survival time of only about 2 years.
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Comment: The same commenter expressed concern about the statement,
in proposed sections 13.00K6b and 113.00K4b, that we consider brain
tumors malignant only if they are classified as grade II or higher
under the World Health Organization (WHO), ``Classification of Tumours
of the Central Nervous System, 2007.'' The commenter asked how an
adjudicator should evaluate central nervous system tumors graded under
different classification systems.
Response: We believe we have addressed the commenter's concerns in
existing operating instructions that help adjudicators determine the
WHO grade of specific brain cancers if a different grading system is
used or if the medical evidence does not identify a particular grading
system.\11\ These instructions also help adjudicators determine which
grade to use when there are inconsistencies in the medical record, such
as some medical evidence describing the tumor as grade II while other
medical evidence describes it as grade III or grade IV.
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\11\ Program Operations Manual System, available at: http://policy.ssa.gov/poms.nsf/lnx/0424585001.
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Listing 13.23--Cancers of the Female Genital Tract--Carcinoma or
Sarcoma

Comment: A commenter recommended that we add criteria in final
listing 13.23B3 to take into account a cancer's histologic diagnosis
and the age of the claimant at onset.
Response: We did not adopt this comment. We do not believe it is
necessary to include such considerations in the listing because the
prognosis is already poor for cervical cancer that meets the specific
criteria of the listing. Considering the histological diagnosis would
only confirm this prognosis, and the prognosis would remain poor
regardless of a person's age.
Comment: A national advocacy group for women with ovarian cancer
recommended that we reinstate a listing we deleted in 2009. The listing
covered ovarian cancer with ruptured ovarian capsule, tumor on the
serosal surface of the ovary, ascites with malignant cells, or positive
peritoneal washings. The commenter believed we find most women with
this extent of disease disabled at later steps of the sequential
evaluation process after the listing step or on appeal. The commenter
also believed the adverse effects of cancer treatment might be
disabling in themselves, especially for women whose jobs require
significant exertion or do not allow time off for recovery from
treatment.
Response: We agree we could find a woman with the findings in the
prior listing disabled after the listing step of the sequential
evaluation process. We realize that adverse effects of ovarian cancer
treatment may preclude a woman from working. However, we did not adopt
the commenter's recommendation because many women with ovarian cancer
that meets the specific criteria in the deleted listing would not have
an impairment that precludes any gainful activity, which is the
standard of severity in the listings.\12\
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\12\ See sections 404.1525 and 416.925.
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Other Changes

We made a number of editorial changes and technical corrections in
the final rule to increase the clarity and consistency of the listings.
For example, we redesignated proposed listing 13.05A3 for evaluating
mantle cell lymphoma in adults as final listing 13.05D to make it a
stand-alone listing consistent with stand-alone final listing 113.05D
for evaluating mantle cell lymphoma in children. We also changed the
parenthetical examples in prior sections 13.00H1 and 113.00H1 from ``at
least 18 months from the date of diagnosis'' and ``at least 12 months
from the date of diagnosis,'' respectively, to ``until at least 12
months from the date of transplantation'' to make these adult and child
sections consistent.
Additionally, we redesignated proposed listings 13.29A3 and
113.29A3 for evaluating mucosal melanoma as stand-alone listings 13.29C
and 113.29C. We made this change because we determined, through our
ongoing review of the scientific and medical literature, that mucosal
melanoma carries a very poor prognosis and is of listing-level severity
regardless of whether it is an initial disease or a recurrent disease.
We also added examples of distant sites frequently affected by
metastases from cutaneous and ocular melanomas in 13.29B3 and 113.29B3.

What is our authority to make regulations and set procedures for
determining whether a person is disabled under the statutory
definition?

Under the Act, we have full power and authority to make rules and
regulations and to establish necessary and appropriate procedures to
carry out such provisions.\13\
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\13\ Sections 205(a), 702(a)(5), and 1631(d)(1).
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Regulatory Procedures

Executive Order 12866, as Supplemented by Executive Order 13563

We have consulted with the Office of Management and Budget (OMB)
and determined that this final rule meets the criteria for a
significant regulatory action under Executive Order 12866, as
supplemented by Executive Order 13563, and was reviewed by OMB.

Regulatory Flexibility Act

We certify that this final rule has no significant economic impact
on a substantial number of small entities because it affects only
individuals. Therefore, a regulatory flexibility analysis was not
required under the Regulatory Flexibility Act, as amended.

Paperwork Reduction Act

This final rule does not create any new or affect any existing
collections and, therefore, does not require OMB approval under the
Paperwork Reduction Act.

(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).

List of Subjects in 20 CFR Part 404

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

Dated: May 11, 2015.
Carolyn W. Colvin,
Acting Commissioner of Social Security.

For the reasons set out in the preamble, we are amending 20 CFR
part 404 subpart P as set forth below:

[[Page 28826]]

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

Subpart P--Determining Disability and Blindness

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),
(i), and (j), 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), (i),
and (j), 422(c), 423, 425, and 902(a)(5)); sec. 211(b), Pub. L. 104-
193, 110 Stat. 2105, 2189; sec. 202, Pub. L. 108-203, 118 Stat. 509
(42 U.S.C. 902 note).

0
2. Amend appendix 1 to subpart P of part 404 as follows:
0
a. Revise item 14 of the introductory text before part A.
0
b. Amend part A by revising the body system name for section 13.00 in
the table of contents.
0
c. Revise section 13.00 of part A.
0
d. Amend listing 13.02 of part A by revising the heading, revising
listing 13.02B, removing listing 13.02C, redesignating listing 13.02D
as new 13.02C, adding new listing 13.02D and revising listing 13.02E.
0
e. Amend listing 13.03 of part A by revising listing 13.03B.
0
f. Amend listing 13.04 of part A by revising listing 13.04B.
0
g. Amend listing 13.05 of part A by revising listings 13.05A1, 13.05A2
and 13.05B, and adding listing 13.05D.
0
h. Amend listing 13.06 of part A by revising the first sentence of
listing 13.06B1 and revising listing 13.06B2b.
0
i. Amend listing 13.07 of part A by revising listing 13.07A.
0
j. Amend listing 13.10 of part A by revising listings 13.10A and
13.10C, adding the word ``OR'' after listing 13.10C, adding listing
13.10D, adding the word ``OR'' after listing 13.10D, and adding listing
13.10E.
0
k. Amend listing 13.11 of part A by revising listings 13.11B and
13.11D.
0
l. Amend listing 13.12 of part A by revising listing 13.12C.
0
m. Revise listing 13.13 of part A.
0
n. Amend listing 13.14C of part A by revising the first sentence.
0
o. Amend listing 13.15 of part A by revising listing 13.15B2 and adding
the word ``OR'' after listing 13.15B2, and adding listing 13.15C.
0
p. Amend listing 13.16 of part A by adding the word ``OR'' after
listing 13.16B, and adding listing 13.16C.
0
q. Amend listing 13.17 of part A by adding the word ``OR'' after
listing 13.17B, and adding listing 13.17C.
0
r. Amend listing 13.18 of part A by adding the word ``OR'' after
listing 13.18C, and adding listing 13.18D.
0
s. Revise listing 13.19 of part A.
0
t. Amend listing 13.20 of part A by revising listing 13.20B.
0
u. Amend listing 13.22 of part A by adding the word ``OR'' after
listing 13.22D, and adding listing 13.22E.
0
v. Amend listing 13.23 of part A by revising the heading, revising
listings 13.23A3, 13.23B, 13.23C3, 13.23D2 and 13.23E, adding the word
``OR'' after listing 13.23E, and adding listing 13.23F.
0
w. Amend listing 13.24 of part A by revising listing 13.24A, adding the
word ``OR'' after listing 13.24B, and adding listing 13.24C.
0
x. Revise listing 13.25 of part A.
0
y. Amend listing 13.28 of part A by revising the heading.
0
z. Add listing 13.29 after listing 13.28 of part A.
0
aa. Amend part B by revising the body system name for section 113.00 in
the table of contents.
0
bb. Revise section 113.00 of part B.
0
cc. Revise listing 113.03 of part B.
0
dd. Amend listing 113.05 of part B by revising the heading and listings
113.05A and 113.05B, adding the word ``OR'' after listing 113.05C, and
adding listing 113.05D.
0
ee. Amend listing 113.06 of part B by revising listings 113.06A and
113.06B1.
0
ff. Amend listing 113.12 of part B by revising listing 113.12B.
0
gg. Revise listing 113.13 of part B.
0
hh. Add listing 113.29 after listing 113.21 of part B.
The revised and added text is set forth as follows:

APPENDIX 1 TO SUBPART P OF PART 404--LISTING OF IMPAIRMENTS

* * * * *
14. Cancer (Malignant Neoplastic Diseases) (13.00 and 113.00):
July 20, 2020.
* * * * *

Part A

* * * * *

13.00 Cancer (Malignant Neoplastic Diseases)

* * * * *

13.00 CANCER (MALIGNANT NEOPLASTIC DISEASES)

[[Page 28827]]

source initiated multimodal anticancer therapy. We do not need to
make a determination about the length or effectiveness of your
therapy. Multimodal therapy has been initiated, and satisfies the
requirements in 13.02E, 13.11D, and 13.14C, when your treating
source starts the first modality. We may defer adjudication if your
treating source plans multimodal therapy and has not yet initiated
it.
F. How do we evaluate impairments that do not meet one of the
cancer listings?
1. These listings are only examples of cancer 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 of this chapter.) 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 of this chapter. We use the rules in Sec. Sec.
404.1594 and 416.994 of this chapter, as appropriate, when we decide
whether you continue to be disabled.
G. How do we consider the effects of anticancer therapy?
1. How we consider the effects of anticancer therapy under the
listings. In many cases, cancers meet listing criteria only if the
therapy is not effective and the cancer persists, progresses, or
recurs. 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. We consider each case on an individual basis because the
therapy and its toxicity may vary widely. 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. The severity of the adverse
effects of anticancer therapy may change during treatment;
therefore, enough time must pass to allow us to evaluate the
therapy's effect. The residual effects of treatment are temporary in
most instances; however, on occasion, the effects may be disabling
for a consecutive period of at least 12 months. In some situations,
very serious adverse effects may interrupt and prolong multimodal
anticancer therapy for a continuous period of almost 12 months. In
these situations, we may determine there is an expectation that your
impairment will preclude you from engaging in any gainful activity
for at least 12 months.
4. When the initial anticancer 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, until at least 12 months from the date of transplantation).
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
or a recurrence (or relapse) 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 cancer or therapy (see
13.00G), in determining whether you are disabled. If you have a
recurrence or relapse of your cancer, your impairment may meet or
medically equal one of the listings in this body system again.
I. What do we mean by the following terms?
1. Anticancer therapy means surgery, radiation, chemotherapy,
hormones, immunotherapy, or bone marrow or stem cell
transplantation. When we refer to surgery as an anticancer
treatment, we mean surgical excision for treatment, not for
diagnostic purposes.
2. Inoperable means surgery is thought to be of no therapeutic
value or the surgery cannot be performed; for example, when you
cannot tolerate anesthesia or surgery because of another
impairment(s), or you have a cancer that is too large or that has
invaded crucial structures. This term does not include situations in
which your cancer could have been surgically removed but another
method of treatment was chosen; for example, an attempt at organ
preservation. Your physician may determine whether the cancer is
inoperable before or after you receive neoadjuvant therapy.
Neoadjuvant therapy is anticancer therapy, such as chemotherapy or
radiation, given before surgery in order to reduce the size of the
cancer.
3. Metastases means the spread of cancer cells by blood, lymph,
or other body fluid. This term does not include the spread of cancer
cells by direct extension of the cancer to other tissues or organs.
4. Multimodal therapy means anticancer therapy that is a
combination of at least two types of treatment given in close
proximity as a unified whole and usually planned before any
treatment has begun. There are three types of treatment modalities:
surgery, radiation, and systemic drug therapy (chemotherapy, hormone
therapy, and immunotherapy or biological modifier therapy). Examples
of multimodal therapy include:
a. Surgery followed by chemotherapy or radiation.
b. Chemotherapy followed by surgery.
c. Chemotherapy and concurrent radiation.
5. Persistent means the planned initial anticancer therapy
failed to achieve a complete remission of your cancer; that is, your
cancer is evident, even if smaller, after the therapy has ended.
6. Progressive means the cancer becomes more extensive after
treatment; that is, there is evidence that your cancer is growing
after you have completed at least half of your planned initial
anticancer therapy.
7. Recurrent or relapse means the cancer that was in complete
remission or entirely removed by surgery has returned.
8. Unresectable means surgery or surgeries did not completely
remove the cancer. This term includes situations in which your
cancer is incompletely resected or the surgical margins are
positive. It does not include situations in which there is a finding
of a positive margin(s) if additional surgery obtains a margin(s)
that is clear. It also does not include situations in which the
cancer is completely resected but you are receiving adjuvant
therapy. Adjuvant therapy is anticancer therapy, such as
chemotherapy or radiation, given after surgery in order to eliminate
any remaining cancer cells or lessen the chance of recurrence.
J. Can we establish the existence of a disabling impairment
prior to the date of the evidence that shows the cancer satisfies
the criteria of a listing? Yes. We will consider factors such as:
1. The type of cancer and its location.
2. The extent of involvement when the cancer was first
demonstrated.
3. Your symptoms.
K. How do we evaluate specific cancers?
1. Lymphoma.
a. Many indolent (non-aggressive) lymphomas are controlled by
well-tolerated treatment modalities, although the lymphomas may
produce intermittent symptoms and signs. We may defer adjudicating
these cases for an appropriate period after therapy is initiated to
determine whether the therapy will achieve its intended effect,
which is usually to stabilize the disease process. (See 13.00E3.)
Once your disease stabilizes, we will assess severity based on the
extent of involvement of other organ systems and residuals from
therapy.
b. A change in therapy for indolent lymphomas is usually an
indicator that the therapy is not achieving its intended effect.
However, your impairment will not meet the requirements of 13.05A2
if your therapy is changed solely because you or your

[[Page 28828]]

physician chooses to change it and not because of a failure to
achieve stability.
c. We consider Hodgkin lymphoma that recurs more than 12 months
after completing initial anticancer 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 on 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, or by testicular biopsy. The
initial and follow-up pathology reports should be included.
b. Chronic myelogenous leukemia (CML). We need a diagnosis of
CML based on 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. The requirement for CML in
the accelerated or blast phase is met in 13.06B if laboratory
findings show the proportion of blast (immature) cells in the
peripheral blood or bone marrow is 10 percent or greater.
c. Chronic lymphocytic leukemia.
i. We require the diagnosis of chronic lymphocytic leukemia
(CLL) to be documented by evidence of a chronic lymphocytosis of at
least 10,000 cells/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 or the
hematological listings (7.00).
d. Elevated white cell count. In cases of chronic leukemia
(either myelogenous or lymphocytic), an elevated white cell count,
in itself, is not a factor in determining the severity of the
impairment.
3. Macroglobulinemia or heavy chain disease. We require the
diagnosis of these diseases to be confirmed by protein
electrophoresis or immunoelectrophoresis. We evaluate the resulting
impairment(s) under the appropriate listings, such as 13.05A2 or the
hematological listings (7.00).
4. Primary breast cancer.
a. 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.
b. We evaluate secondary lymphedema that results from anticancer
therapy for breast cancer under 13.10E if the lymphedema is treated
by surgery to salvage or restore the functioning of an upper
extremity. Secondary lymphedema is edema that results from
obstruction or destruction of normal lymphatic channels. We may not
restrict our determination of the onset of disability to the date of
the surgery; we may establish an earlier onset date of disability if
the evidence in your case record supports such a finding.
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. Primary central nervous system (CNS) cancers. We use the
criteria in 13.13 to evaluate cancers that originate within the CNS
(that is, brain and spinal cord cancers).
a. The CNS cancers listed in 13.13A1 are highly malignant and
respond poorly to treatment, and therefore we do not require
additional criteria to evaluate them. We do not list pituitary gland
cancer (for example, pituitary gland carcinoma) in 13.13A1, although
this CNS cancer is highly malignant and responds poorly to
treatment. We evaluate pituitary gland cancer under 13.13A1 and do
not require additional criteria to evaluate it.
b. We consider a CNS tumor to be malignant if it is classified
as Grade II, Grade III, or Grade IV under the World Health
Organization (WHO) classification of tumors of the CNS (WHO
Classification of Tumours of the Central Nervous System, 2007).
c. We evaluate benign (for example, WHO Grade I) CNS tumors
under 11.05. We evaluate metastasized CNS cancers from non-CNS sites
under the primary cancers (see 13.00C). We evaluate any
complications of CNS cancers, such as resultant neurological or
psychological impairments, under the criteria for the affected body
system.
7. Primary peritoneal carcinoma. We use the criteria in 13.23E
to evaluate primary peritoneal carcinoma in women because this
cancer is often indistinguishable from ovarian cancer and is
generally treated the same way as ovarian cancer. We use the
criteria in 13.15A to evaluate primary peritoneal carcinoma in men
because many of these cases are similar to malignant mesothelioma.
8. Prostate cancer. We exclude ``biochemical recurrence'' in
13.24A, which is defined as an increase in the serum prostate-
specific antigen (PSA) level following the completion of the
hormonal intervention therapy. We need corroborating evidence to
document recurrence, such as radiological studies or findings on
physical examination.
9. Melanoma. We evaluate malignant melanoma that affects the
skin (cutaneous melanoma), eye (ocular melanoma), or mucosal
membranes (mucosal melanoma) under 13.29. We evaluate melanoma that
is not malignant that affects the skin (benign melanocytic tumor)
under the listings in 8.00 or other affected body systems.
L. How do we evaluate cancer treated by bone marrow or stem cell
transplantation, including transplantation using stem cells from
umbilical cord blood? Bone marrow or stem cell transplantation is
performed for a variety of cancers. We require the transplantation
to occur before we evaluate it under these listings. We do not need
to restrict our determination of the onset of disability to the date
of the transplantation (13.05, 13.06, or 13.07) or the date of first
treatment under the treatment plan that includes transplantation
(13.28). We may be able to establish an earlier onset date of
disability due to your transplantation if the evidence in your case
record supports such a finding.
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 cancers. We will evaluate any other cancer 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.
* * * * *
13.02 Soft tissue cancers of the head and neck (except salivary
glands--13.08--and thyroid gland--13.09).
* * * * *
B. Persistent or recurrent disease following initial anticancer
therapy, except persistence or recurrence in the true vocal cord.
* * * * *
D. Small-cell (oat cell) carcinoma.
OR
E. Soft tissue cancers originating in the head and neck treated
with multimodal anticancer therapy (see 13.00E3c). Consider under a
disability until at least 18 months from the date of diagnosis.
Thereafter,

[[Page 28829]]

evaluate any residual impairment(s) under the criteria for the
affected body system.
13.03 Skin (except malignant melanoma--13.29).
* * * * *
B. Carcinoma invading deep extradermal structures (for example,
skeletal muscle, cartilage, or bone).
13.04 Soft tissue sarcoma.
* * * * *
B. Persistent or recurrent following initial anticancer therapy.
13.05 Lymphoma (including mycosis fungoides, but excluding T-
cell lymphoblastic lymphoma--13.06). (See 13.00K1 and 13.00K2c.)
A. Non-Hodgkin lymphoma, as described in 1 or 2:
1. Aggressive lymphoma (including diffuse large B-cell lymphoma)
persistent or recurrent following initial anticancer therapy.
2. Indolent lymphoma (including mycosis fungoides and follicular
small cleaved cell) requiring initiation of more than one (single
mode or multimodal) anticancer treatment regimen within a period of
12 consecutive months. Consider under a disability from at least the
date of initiation of the treatment regimen that failed within 12
months.
OR
B. Hodgkin lymphoma with failure to achieve clinically complete
remission, or recurrent lymphoma within 12 months of completing
initial anticancer therapy.
* * * * *
OR
D. Mantle cell lymphoma.
13.06 Leukemia. (See 13.00K2.)
* * * * *
B. * * *
1. Accelerated or blast phase (see 13.00K2b). * * *
* * * * *
2. Chronic phase, as described in a or b:
* * * * *
b. Progressive disease following initial anticancer 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
anticancer therapy.
* * * * *
13.10 Breast (except sarcoma--13.04). (See 13.00K4.)
A. Locally advanced cancer (inflammatory carcinoma, cancer of
any size with direct extension to the chest wall or skin, or cancer
of any size with metastases to the ipsilateral internal mammary
nodes).
* * * * *
C. Recurrent carcinoma, except local recurrence that remits with
anticancer therapy.
OR
D. Small-cell (oat cell) carcinoma.
OR
E. With secondary lymphedema that is caused by anticancer
therapy and treated by surgery to salvage or restore the functioning
of an upper extremity. (See 13.00K4b.) Consider under a disability
until at least 12 months from the date of the surgery that treated
the secondary lymphedema. Thereafter, evaluate any residual
impairment(s) under the criteria for the affected body system.
13.11 Skeletal system--sarcoma.
* * * * *
B. Recurrent cancer (except local recurrence) after initial
anticancer therapy.
* * * * *
D. All other cancers originating in bone with multimodal
anticancer therapy (see 13.00E3c). 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.
* * * * *
C. Cancer with extension to the orbit, meninges, sinuses, or
base of the skull.
13.13 Nervous system. (See 13.00K6.)
A. Primary central nervous system (CNS; that is, brain and
spinal cord) cancers, as described in 1, 2, or 3:
1. Glioblastoma multiforme, ependymoblastoma, and diffuse
intrinsic brain stem gliomas (see 13.00K6a).
2. Any Grade III or Grade IV CNS cancer (see 13.00K6b),
including astrocytomas, sarcomas, and medulloblastoma and other
primitive neuroectodermal tumors (PNETs).
3. Any primary CNS cancer, as described in a or b:
a. Metastatic.
b. Progressive or recurrent following initial anticancer
therapy.
OR
B. Primary peripheral nerve or spinal root cancers, as described
in 1 or 2:
1. Metastatic.
2. Progressive or recurrent following initial anticancer
therapy.
13.14 Lungs.
* * * * *
C. Carcinoma of the superior sulcus (including Pancoast tumors)
with multimodal anticancer therapy (see 13.00E3c). * * *
* * * * *
13.15 Pleura or mediastinum.
* * * * *
B. * * *
2. Persistent or recurrent following initial anticancer therapy.
OR
C. Small-cell (oat cell) carcinoma.
13.16 Esophagus or stomach.
* * * * *
B. * * *
OR
C. Small-cell (oat cell) carcinoma.
13.17 Small intestine--carcinoma, sarcoma, or carcinoid.
* * * * *
B. * * *
OR
C. Small-cell (oat cell) carcinoma.
13.18 Large intestine (from ileocecal valve to and including
anal canal).
* * * * *
C. * * *
OR
D. Small-cell (oat cell) carcinoma.
13.19 Liver or gallbladder--cancer of the liver, gallbladder, or
bile ducts.
13.20 Pancreas.
* * * * *
B. Islet cell carcinoma that is physiologically active and is
either inoperable or unresectable.
* * * * *
13.22 Urinary bladder--carcinoma.
* * * * *
D. * * *
OR
E. Small-cell (oat cell) carcinoma.
13.23 Cancers of the female genital tract--carcinoma or sarcoma
(including primary peritoneal carcinoma).
A. * * *
3. Persistent or recurrent following initial anticancer therapy.
B. Uterine cervix, as described in 1, 2, or 3:
1. Extending to the pelvic wall, lower portion of the vagina, or
adjacent or distant organs.
2. Persistent or recurrent following initial anticancer therapy.
3. With metastases to distant (for example, para-aortic or
supraclavicular) lymph nodes.
C. * * *
3. Persistent or recurrent following initial anticancer therapy.
D. * * *
2. Persistent or recurrent following initial anticancer therapy.
E. Ovaries, as described in 1 or 2:
1. All cancers except germ-cell cancers, with at least one of
the following:
a. Extension beyond the pelvis; for example, implants on, or
direct extension to, peritoneal, omental, or bowel surfaces.
b. Metastases to or beyond the regional lymph nodes.
c. Recurrent following initial anticancer therapy.
2. Germ-cell cancers--progressive or recurrent following initial
anticancer therapy.
OR
F. Small-cell (oat cell) carcinoma.
13.24 Prostate gland--carcinoma.
A. Progressive or recurrent (not including biochemical
recurrence) despite initial hormonal intervention. (See 13.00K8.)
OR
B. * * *
OR
C. Small-cell (oat cell) carcinoma.
13.25 Testicles--cancer with metastatic disease progressive or
recurrent following initial chemotherapy.
* * * * *
13.28 Cancer treated by bone marrow or stem cell
transplantation. (See 13.00L.)
* * * * *
13.29 Malignant melanoma (including skin, ocular, or mucosal
melanomas), as described in either A, B, or C:
A. Recurrent (except an additional primary melanoma at a
different site, which is not considered to be recurrent disease)
following either 1 or 2:
1. Wide excision (skin melanoma).
2. Enucleation of the eye (ocular melanoma).
OR
B. With metastases as described in 1, 2, or 3:

[[Page 28830]]

1. Metastases to one or more clinically apparent nodes; that is,
nodes that are detected by imaging studies (excluding
lymphoscintigraphy) or by clinical evaluation (palpable).
2. If the nodes are not clinically apparent, with metastases to
four or more nodes.
3. Metastases to adjacent skin (satellite lesions) or distant
sites (for example, liver, lung, or brain).
OR
C. Mucosal melanoma.
* * * * *

Part B

* * * * *

113.00 Cancer (Malignant Neoplastic Diseases)

* * * * *

113.00 CANCER (MALIGNANT NEOPLASTIC DISEASES)

A. What impairments do these listings cover? We use these
listings to evaluate all cancers (malignant neoplastic diseases),
except certain cancers associated with human immunodeficiency virus
(HIV) infection. If you have HIV infection, we use the criteria in
114.08E to evaluate carcinoma of the cervix, Kaposi sarcoma,
lymphoma, and squamous cell carcinoma of the anal canal and anal
margin.
B. What do we consider when we evaluate cancer under these
listings? We will consider factors including:
1. Origin of the cancer.
2. Extent of involvement.
3. Duration, frequency, and response to anticancer therapy.
4. Effects of any post-therapeutic residuals.
C. How do we apply these listings? We apply the criteria in a
specific listing to a cancer 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 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, and
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 cancer, the response
to therapy, and any significant residuals. (See 113.00G.)
E. When do we need longitudinal evidence?
1. Cancer with distant metastases. Most cancer of childhood
consists of a local lesion with metastases to regional lymph nodes
and, less often, distant metastases. We generally do not need
longitudinal evidence for cancer that has metastasized beyond the
regional lymph nodes because this cancer usually meets the
requirements of a listing. Exceptions are for cancer with distant
metastases that we expect to respond to anticancer therapy. For
these exceptions, we usually need a longitudinal record of 3 months
after therapy starts to determine whether the therapy achieved its
intended effect, and whether this effect is likely to persist.
2. Other cancers. When there are no distant metastases, many of
the listings require that we consider your response to initial
anticancer therapy; that is, the initial planned treatment regimen.
This therapy may consist of a single modality or a combination of
modalities; that is, multimodal therapy (see 113.00I3).
3. Types of treatment.
a. 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 often happens within 6 months after treatment starts,
and there will often be a change in the treatment regimen.
b. Whenever the initial planned therapy is multimodal, we
usually cannot make a determination about the effectiveness of the
therapy until we can determine the effects of all the planned
modalities. In some cases, we may need to defer adjudication until
we can assess the effectiveness of therapy. 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 cancer or therapy (see 113.00G).
F. How do we evaluate impairments that do not meet one of the
cancer listings?
1. These listings are only examples of cancers that we consider
severe enough to result in marked and severe functional limitations.
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 of this chapter.) If your impairment(s) does not meet or
medically equal a listing, we will also consider whether you have an
impairment(s) that functionally equals the listings. (See Sec.
416.926a of this chapter.) We use the rules in Sec. 416.994a of
this chapter when we decide whether you continue to be disabled.
G. How do we consider the effects of anticancer therapy?
1. How we consider the effects of anticancer therapy under the
listings. In many cases, cancers meet listing criteria only if the
therapy is not effective and the cancer persists, progresses, or
recurs. 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. We consider each case on an individual basis because the
therapy and its toxicity may vary widely. 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. The severity of the adverse
effects of anticancer therapy may change during treatment;
therefore, enough time must pass to allow us to evaluate the
therapy's effect. The residual effects of treatment are temporary in
most instances; however, on occasion, the effects may be disabling
for a consecutive period of at least 12 months. In some situations,
very serious adverse effects may interrupt and prolong multimodal
anticancer therapy for a continuous period of almost 12 months. In
these situations, we may determine there is an expectation that your
impairment will preclude you from engaging in any age-appropriate
activities for at least 12 months.
4. When the initial anticancer 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 listing, 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, until at least 12 months from the date of transplantation).
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
or a recurrence (or relapse) 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 cancer or therapy (see
113.00G), in determining whether you are disabled. If you have a
recurrence or relapse of your cancer, your impairment may meet or
medically equal one of the listings in this body system again.
I. What do we mean by the following terms?

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1. Anticancer therapy means surgery, radiation, chemotherapy,
hormones, immunotherapy, or bone marrow or stem cell
transplantation. When we refer to surgery as an anticancer
treatment, we mean surgical excision for treatment, not for
diagnostic purposes.
2. Metastases means the spread of cancer cells by blood, lymph,
or other body fluid. This term does not include the spread of cancer
cells by direct extension of the cancer to other tissues or organs.
3. Multimodal therapy means anticancer therapy that is a
combination of at least two types of treatment given in close
proximity as a unified whole and usually planned before any
treatment has begun. There are three types of treatment modalities:
Surgery, radiation, and systemic drug therapy (chemotherapy, hormone
therapy, and immunotherapy or biological modifier therapy). Examples
of multimodal therapy include:
a. Surgery followed by chemotherapy or radiation.
b. Chemotherapy followed by surgery.
c. Chemotherapy and concurrent radiation.
4. Persistent means the planned initial anticancer therapy
failed to achieve a complete remission of your cancer; that is, your
cancer is evident, even if smaller, after the therapy has ended.
5. Progressive means the cancer becomes more extensive after
treatment; that is, there is evidence that your cancer is growing
after you have completed at least half of your planned initial
anticancer therapy.
6. Recurrent or relapse means the cancer that was 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 cancer satisfies
the criteria of a listing? Yes. We will consider factors such as:
1. The type of cancer and its location.
2. The extent of involvement when the cancer was first
demonstrated.
3. Your symptoms.
K. How do we evaluate specific cancers?
1. Lymphoma.
a. We provide criteria for evaluating lymphomas that are
disseminated or have not responded to anticancer therapy in 113.05.
b. Lymphoblastic lymphoma is treated with leukemia-based
protocols, so we evaluate this type of cancer under 113.06.
2. Leukemia.
a. Acute leukemia. The initial diagnosis of acute leukemia,
including the accelerated or blast phase of chronic myelogenous
(granulocytic) leukemia, is based on 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, or by testicular biopsy. The
initial and follow-up pathology reports should be included.
b. Chronic myelogenous leukemia (CML). We need a diagnosis of
CML based on 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. The requirement for CML in
the accelerated or blast phase is met in 113.06B if laboratory
findings show the proportion of blast (immature) cells in the
peripheral blood or bone marrow is 10 percent or greater.
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
(either myelogenous or lymphocytic), an elevated white cell count,
in itself, is not 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. We do not evaluate thyroid cancer (see 113.09),
retinoblastomas (see 113.12), primary central nervous system (CNS)
cancers (see 113.13), neuroblastomas (see 113.21), or malignant
melanoma (see 113.29) under this listing.
4. Primary central nervous system (CNS) cancers. We use the
criteria in 113.13 to evaluate cancers that originate within the CNS
(that is, brain and spinal cord cancers).
a. The CNS cancers listed in 113.13A are highly malignant and
respond poorly to treatment, and therefore we do not require
additional criteria to evaluate them. We do not list pituitary gland
cancer (for example, pituitary gland carcinoma) in 113.13A, although
this CNS cancer is highly malignant and responds poorly to
treatment. We evaluate pituitary gland cancer under 113.13A and do
not require additional criteria to evaluate it.
b. We consider a CNS tumor to be malignant if it is classified
as Grade II, Grade III, or Grade IV under the World Health
Organization (WHO) classification of tumors of the CNS (WHO
Classification of Tumours of the Central Nervous System, 2007).
c. We evaluate benign (for example, WHO Grade I) CNS tumors
under 111.05. We evaluate metastasized CNS cancers from non-CNS
sites under the primary cancers (see 113.00C). We evaluate any
complications of CNS cancers, such as resultant neurological or
psychological impairments, under the criteria for the affected body
system.
5. Retinoblastoma. The treatment for bilateral retinoblastoma
usually results in a visual impairment. We will evaluate any
resulting visual impairment under 102.02.
6. Melanoma. We evaluate malignant melanoma that affects the
skin (cutaneous melanoma), eye (ocular melanoma), or mucosal
membranes (mucosal melanoma) under 113.29. We evaluate melanoma that
is not malignant that affects the skin (benign melanocytic tumor)
under the listings in 108.00 or other affected body systems.
L. How do we evaluate cancer treated by bone marrow or stem cell
transplantation, including transplantation using stem cells from
umbilical cord blood? Bone marrow or stem cell transplantation is
performed for a variety of cancers. We require the transplantation
to occur before we evaluate it under these listings. We do not need
to restrict our determination of the onset of disability to the date
of transplantation (113.05 or 113.06). We may be able to establish
an earlier onset date of disability due to your transplantation if
the evidence in your case record supports such a finding.
1. Acute leukemia (including all types of lymphoblastic
lymphomas 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, Cancer (Malignant Neoplastic
Diseases)
113.03 Malignant solid tumors. Consider under a disability:
A. For 24 months from the date of initial diagnosis. Thereafter,
evaluate any residual impairment(s) under the criteria for the
affected body system.
OR
B. For 24 months 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 all types of lymphoblastic
lymphomas--113.06). (See 113.00K1.)
A. Non-Hodgkin lymphoma (including Burkitt's and anaplastic
large cell), with either 1 or 2:
1. Bone marrow, brain, spinal cord, liver, or lung involvement
at initial diagnosis. Consider under a disability for 24 months from
the date of diagnosis. Thereafter, evaluate under 113.05A2, or any
residual impairments(s) under the criteria for the affected body
system.
2. Persistent or recurrent following initial anticancer therapy.
OR
B. Hodgkin lymphoma, with either 1 or 2:
1. Bone marrow, brain, spinal cord, liver, or lung involvement
at initial diagnosis. Consider under a disability for 24 months from
the date of diagnosis. Thereafter, evaluate under 113.05B2, or any
residual impairment(s) under the criteria for the affected body
system.
2. Persistent or recurrent following initial anticancer therapy.

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OR
* * * * *
OR
D. Mantle cell lymphoma.
113.06 Leukemia. (See 113.00K2.)
A. Acute leukemia (including all types of lymphoblastic
lymphomas 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. * * *
1. Accelerated or blast phase (see 113.00K2b). 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.
* * * * *
113.12 Retinoblastoma.
* * * * *
B. Persistent or recurrent following initial anticancer therapy.
* * * * *
113.13 Nervous system. (See 113.00K4.) Primary central nervous
system (CNS; that is, brain and spinal cord) cancers, as described
in A, B, or C:
A. Glioblastoma multiforme, ependymoblastoma, and diffuse
intrinsic brain stem gliomas (see 113.00K4a).
B. Any Grade III or Grade IV CNS cancer (see 113.00K4b),
including astrocytomas, sarcomas, and medulloblastoma and other
primitive neuroectodermal tumors (PNETs).
C. Any primary CNS cancer, as described in 1 or 2:
1. Metastatic.
2. Progressive or recurrent following initial anticancer
therapy.
* * * * *
113.29 Malignant melanoma (including skin, ocular, or mucosal
melanomas), as described in either A, B, or C:
A. Recurrent (except an additional primary melanoma at a
different site, which is not considered to be recurrent disease)
following either 1 or 2:
1. Wide excision (skin melanoma).
2. Enucleation of the eye (ocular melanoma).
OR
B. With metastases as described in 1, 2, or 3:
1. Metastases to one or more clinically apparent nodes; that is,
nodes that are detected by imaging studies (excluding
lymphoscintigraphy) or by clinical evaluation (palpable).
2. If the nodes are not clinically apparent, with metastases to
four or more nodes.
3. Metastases to adjacent skin (satellite lesions) or distant
sites (for example, liver, lung, or brain).
OR
C. Mucosal melanoma.
* * * * *

[FR Doc. 2015-11923 Filed 5-19-15; 8:45 am]
BILLING CODE 4191-02-P