[Federal Register Volume 78, Number 242 (Tuesday, December 17, 2013)]
[Proposed Rules]
[Pages 76508-76519]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-30088]



[[Page 76507]]

Vol. 78

Tuesday,

No. 242

December 17, 2013

Part V





Social Security Administration





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20 CFR Part 404





Revised Medical Criteria for Evaluating Cancer (Malignant Neoplastic 
Diseases); Proposed Rule

  Federal Register / Vol. 78 , No. 242 / Tuesday, December 17, 2013 / 
Proposed Rules  

[[Page 76508]]


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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: Notice of proposed rulemaking.

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SUMMARY: We propose to revise the criteria in parts A and B of the 
Listing of Impairments (listings) that we use to evaluate cases 
involving cancer (malignant neoplastic diseases) in adults and children 
under titles II and XVI of the Social Security Act (Act). These 
proposed revisions reflect our adjudicative experience, advances in 
medical knowledge, and recommendations from medical experts we 
consulted, as well as public comments we received on methods of 
evaluating cancer.

DATES: To ensure that your comments are considered, we must receive 
them no later than February 18, 2014.

ADDRESSES: You may submit comments by one of three methods--Internet, 
fax, or mail. Do not submit the same comments multiple times or by more 
than one method. Regardless of which method you choose, please state 
that your comments refer to Docket No. SSA-2011-0098 so that we may 
associate your comments with the correct regulation.
    Caution: You should be careful to include in your comments only 
information that you wish to make publicly available. We strongly urge 
you not to include in your comments any personal information, such as 
your Social Security number or medical information.
    1. Internet: We recommend that you submit your comments via the 
Internet. Please visit the Federal eRulemaking portal at http://www.regulations.gov. Use the Search function to find docket number SSA-
2011-0098. The system will issue a tracking number to confirm your 
submission. You will not be able to view your comment immediately 
because we must post each comment manually. It may take up to a week 
for your comment to be viewable.
    2. Fax: Fax comments to (410) 966-2830.
    3. Mail: Address your comments to the Office of Regulations and 
Reports Clearance, Social Security Administration, 107 Altmeyer 
Building, 6401 Security Boulevard, Baltimore, Maryland 21235-6401.
    Comments are available for public viewing on the Federal 
eRulemaking portal at http://www.regulations.gov, or in person, during 
regular business hours, by arranging with the contact person identified 
below.

FOR FURTHER INFORMATION CONTACT: Cheryl A. Williams, Office of Medical 
Listings Improvement, 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:

What revisions are we proposing?

    We propose to:
     Change the name of this body system;
     Add several new listings and revise some current ones;
     Revise the introductory text of these listings to provide 
more information about how we evaluate cancer and to reflect the new 
listings; and
     Make editorial changes throughout the rules to make the 
rules internally consistent.

Why are we proposing to make these changes?

    We last issued final rules revising these listings on October 6, 
2009, effective November 5, 2009.\1\ We stated in the preamble of the 
final rules that we would continue to monitor these listings and revise 
them, if warranted, before their eight-year effective period ends in 
2017. These proposed revisions reflect our adjudicative experience, 
advances in medical knowledge, and recommendations from medical experts 
we consulted. They also reflect public comments we received on a notice 
of proposed rulemaking (NPRM) that we published in 2008 before issuing 
the final rules in 2009.\2\ We did not address these public comments at 
the time because they were outside the scope of the 2008 NPRM.
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    \1\ 74 FR 51229.
    \2\ 73 FR 22871 (April 28, 2008). Public comments are available 
at http://www.regulations.gov/#!docketDetail;rpp=10;po=0;D=SSA-2007-
0066.
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Why are we proposing to change the name of this body system?

    We propose to change the name of this body system from ``Malignant 
Neoplastic Diseases'' to ``Cancer'' to improve clarity and ease of use 
of the listings. While both terms represent the same condition, 
``cancer'' is a more commonly used term, and more recognized by the lay 
public and by health care professionals. The phrase ``malignant 
neoplastic disease'' is a term used almost exclusively, although 
infrequently, by health care professionals. We would also replace the 
term ``malignant neoplastic diseases'' with the term ``cancer'' in the 
introductory text and listings.

What changes are we proposing to make in the introductory text of the 
listings for evaluating cancer in adults?

    The following is a detailed explanation of the significant changes 
we would make to the introductory text:

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

    We propose to restructure current section 13.00E3 for clarity. We 
would also add proposed 13.00E3c to clarify how we evaluate cancer 
treated with multimodal antineoplastic therapy under certain listings. 
We would explain that we need evidence under current listings 13.02E, 
13.11D, and 13.14C to establish that the treating source has initiated 
multimodal therapy. We also explain that we may defer adjudication if 
the treating source plans multimodal therapy but has not yet initiated 
it.

Proposed Section 13.00I--What do we mean by the following terms?

    We propose several changes in section 13.00I:
     We would add the term ``antineoplastic therapy'' to the 
list of defined terms. We would move the definition of ``antineoplastic 
therapy'' from current section 13.00B3 to proposed section 13.00I1. 
This change will make it easier for our adjudicators to find the 
definition for ``antineoplastic therapy.'' We would renumber the 
definitions in proposed section 13.00I that follow the definition for 
``antineoplastic therapy.''
     We would revise and expand the definition of the term 
``persistent'' in current section 13.00I4 (proposed section 13.00I5) to 
reflect how the meaning of this term relates to the outcome of initial 
antineoplastic therapy. Similarly, we would revise and expand the 
definition of the term ``progressive'' in current section 13.00I5 
(proposed section 13.00I6) to reflect how its meaning relates to the 
outcome of therapy.
     We would revise and expand the definition of the term 
``unresectable'' in current section 13.00I7 (proposed section 13.00I8) 
to explain situations in which positive surgical margins would not 
indicate unresectable cancer. We

[[Page 76509]]

propose this change because the initial surgery may be followed by 
additional surgery that eliminates the positive surgical margins.

Proposed Section 13.00K--How do we evaluate specific cancers?

    We propose several changes to current section 13.00K:
     We would revise current section 13.00K2b to explain that 
we consider chronic myelogenous leukemia (CML) to be in the 
``accelerated'' or ``blast'' phase when the proportion of blast 
(immature) cells in the peripheral blood or bone marrow is 10 percent 
or greater. We propose this change in response to questions we have 
received from our adjudicators.
     We would remove the word ``ordinarily'' from current 
section 13.00K2d to clarify that we do not consider an increase in a 
person's white blood cell count alone to be sufficient evidence to 
determine the severity of chronic leukemia. The word ``ordinarily'' may 
be misinterpreted to mean there are some situations in which an 
increase in the white blood cell count by itself may determine 
severity, and this interpretation would be contrary to our intent.
     We would revise and expand current section 13.00K3 to 
explain that we can evaluate macroglobulinemia or heavy chain disease 
under current listing 13.05A2. We would make this change to recognize 
that current medical practice may treat macroglobulinemia as an 
indolent non-Hodgkin lymphoma. We also explain that we may evaluate 
macroglobulinemia or heavy chain disease under the appropriate listings 
in the hematological body system (7.00). We would make a similar change 
in current section 13.00K2cii to explain that we may evaluate the 
complications and residual impairments from chronic lymphocytic 
leukemia under the appropriate listings in the hematological body 
system.
     We would make two changes to revise and expand current 
section 13.00K4. First, we would use the broader heading, ``Primary 
breast cancer,'' rather than the current heading, ``Bilateral primary 
breast cancer.'' Second, we would add guidance to explain how we 
evaluate secondary lymphedema resulting from breast cancer treatment 
under proposed listing 13.10E. We would continue to include guidance in 
the revised section to explain how we evaluate bilateral primary breast 
cancer under current listing 13.10A.
     We would reorganize and revise section 13.00K6 to explain 
why we evaluate specific central nervous system (CNS) cancers by 
diagnosis alone, unlike other CNS cancers that we evaluate based on a 
World Health Organization (WHO) grade. We also explain that we use the 
criteria in listing 13.13 to evaluate ``primary central nervous system 
cancers,'' which means cancers that originate within the central 
nervous system, that is, brain and spinal cord cancers.
     We would add section 13.00K7 to explain that we can 
evaluate primary peritoneal carcinoma in women under current listing 
13.23E for ovarian cancer. This change responds to a public comment on 
the 2008 NPRM that suggested we provide guidance for evaluating this 
type of cancer. We can evaluate primary peritoneal carcinoma in women 
under listing 13.23E because the disease course, treatment, and outcome 
are more similar to ovarian cancer than other cancers. We also explain 
that we can evaluate primary peritoneal carcinoma in men under current 
listing 13.15A for malignant mesothelioma because many of these cases 
in men are similar to malignant mesothelioma.
     We would add section 13.00K8 to explain that current 
listing 13.24A for recurrent prostate cancer does not include 
``biochemical recurrence,'' as measured with the cancer biomarker 
prostate-specific antigen (PSA). Although the PSA biomarker may track 
the progression of the person's prostate cancer, we do not consider PSA 
useful in determining disability because its values do not necessarily 
correlate with a person's degree of functional impairment.
     We would add section 13.00K9 to explain that we evaluate 
any malignant melanoma under proposed new listing 13.29. As we note in 
our detailed explanation of proposed 13.29 below, malignant melanoma 
may occur in places besides the skin, such as in the eyes and mucosal 
membranes. The proposed listing provides comprehensive criteria to 
reflect the full range of malignant melanomas. We would also explain 
that we evaluate benign melanoma under the listings in 8.00 or other 
affected body systems.

Proposed Section 13.00L--How do we evaluate cancer treatment by bone 
marrow or stem cell transplantation, including transplantation using 
stem cells from umbilical cord blood?

    We would revise current section 13.00L to further explain how we 
evaluate cancers treated with bone marrow or stem cell transplantation, 
including transplantation using stem cells from umbilical cord blood. 
We explain that the transplantation must occur before we will evaluate 
it under the listings. We also explain that we may establish an onset 
date of disability that is earlier than the date of the 
transplantation, or the date of first treatment in a treatment regimen 
that includes transplantation, if an earlier onset date is consistent 
with the evidence in the case record.

How do we propose to revise the criteria in the listings for evaluating 
cancer in adults?

    We propose to add a criterion in several of the listings for 
evaluating small-cell (oat cell) carcinoma. We currently only have a 
listing for small-cell carcinoma in the lungs (listing 13.14). Small-
cell carcinoma may originate in places in the body other than the 
lungs. We would add a criterion for small-cell carcinoma to the 
listings for these other places.\3\ We propose this change in light of 
our adjudicative experience and the current medical literature 
establishing that in most instances small-cell carcinomas are of 
listing-level severity regardless of where they occur in the body.
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    \3\ The criterion for evaluating small-cell (oat cell) carcinoma 
would be added under these proposed 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 cancers of the prostate gland.
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Proposed Listing 13.02--Soft Tissue Cancers of the Head and Neck 
(Except Salivary Glands--13.08--and Thyroid Gland--13.09)

    We propose to revise current listing 13.02 for soft tissue cancer 
of the head and neck by removing the requirement for persistent disease 
following initial multimodal antineoplastic therapy from current 
listing 13.02B. Based on our adjudicative experience and information 
from medical experts, we believe persistent cancer following a 
treatment plan using only a single mode of therapy (for example, solely 
radiation) is also an indication of head and neck cancer of listing-
level severity. We would evaluate cancer that is either persistent or 
recurrent following initial antineoplastic therapy under proposed 
listing 13.02B. We would delete current listing 13.02C because we would 
also evaluate recurrent cancer under proposed listing 13.02B. We would 
also redesignate current listing 13.02D as listing 13.02C.
    In proposed 13.02B, we also propose to exclude cancer in the true 
vocal cords that is persistent or recurrent following initial 
antineoplastic therapy.

[[Page 76510]]

Physicians often treat cancer at this location with radiation therapy 
to preserve the larynx, but if the cancer persists or recurs, they are 
able to remove the cancer with surgery.

Proposed Listing 13.03--Skin (Except Malignant Melanoma--13.29)

    We would revise current listing 13.03 by adding a criterion, 
proposed listing 13.03B, to evaluate skin cancer that invades deep 
extradermal structures, such as skeletal muscle, cartilage, or bone. 
Skin cancer with these findings is often unresectable. We propose to 
add this criterion to be consistent with the criteria for other cancers 
that are unresectable and to recognize the poor prognosis for this 
condition. We would evaluate malignant melanoma of the skin under 
proposed listing 13.29, which we explain in more detail below.

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

    We would add proposed listing 13.05A3 for evaluating mantle cell 
lymphoma (MCL), a high-grade, non-Hodgkin lymphoma. Current medical 
practice is unable to achieve a long-lasting remission in MCL or 
significantly increase a person's life expectancy. Similar to other 
cancers (for example, liver or gallbladder cancer) with a very poor 
prognosis, we would consider a person disabled on a confirmed diagnosis 
of MCL.

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

    Secondary lymphedema that results from breast cancer treatment (for 
example, radiation treatment) may advance to the point that the person 
needs surgery to treat the lymphedema and restore the functional use of 
an upper extremity. We propose to add listing 13.10E to find the person 
disabled for at least 12 months from the date of this surgery that 
treated the secondary lymphedema. After that, we would evaluate any 
residual impairment(s) under the criteria for the affected body system. 
We propose this new criterion to recognize the debilitating effects of 
advanced secondary lymphedema, as well as the time needed to recover 
from the surgery.

Proposed Listing 13.12--Maxilla, Orbit, or Temporal Fossa

    We propose to make a minor editorial change to current listing 
13.12C by moving the term ``base of the skull'' to the end of the 
sentence. We do not intend for the word ``base'' in this term to apply 
to the ``orbit,'' ``meninges,'' or ``sinuses.'' We believe the proposed 
editorial change will make the current sentence structure clearer.

Proposed Listing 13.13--Nervous System

    We propose to reorganize and revise current 13.13A. We would list 
separately in proposed listings 13.13A1 and 13.13A2 highly malignant 
primary CNS cancers that we consider to be of listing-level severity by 
diagnosis alone. These CNS cancers include Grade III and Grade IV 
astrocytomas, and medulloblastoma and other primitive neuroectodermal 
tumors (PNETs). We would no longer require highly malignant PNETs to 
have documented metastases. Our adjudicative experience and the current 
medical literature establish that Grade III and Grade IV PNETs do not 
respond well to treatment and in most instances have a poor prognosis. 
We would evaluate all other primary CNS cancers, including low-grade 
PNETs, under proposed 13.13A3 or 13.13B.

Proposed Listing 13.20--Pancreas

    We propose to make a minor editorial change to current listing 
13.20B for islet cell cancer of the pancreas in response to questions 
from our adjudicators. We would reorganize the listing to clarify that 
the requirement of ``physiologically active'' cancer applies to tumors 
that are either inoperable or unresectable.

Proposed Listing 13.23--Cancers of the Female Genital Tract--Carcinoma 
or Sarcoma (Including Primary Peritoneal Carcinoma)

    We propose to add listing 13.23B3 for cervical cancer that has 
spread to distant (for example, para-aortic or supraclavicular) lymph 
nodes. Current medical literature establishes that cervical cancer with 
involvement of distant lymph nodes is associated with a poor prognosis 
and short-term survival, as well as a high recurrence rate.
    We also propose to make a minor editorial change in current listing 
13.23E1a for ovarian cancer to clarify that the spread of the cancer 
beyond the pelvis includes direct extension of the tumor. We currently 
find claimants who have direct tumor extension to the peritoneal, 
omental, or bowel surfaces to be disabled based on medical equivalence 
to the current listing.

Proposed Listing 13.29--Malignant Melanoma (Including Skin, Ocular, or 
Mucosal Melanomas)

    We propose to evaluate malignant melanoma separately from other 
cancers that involve the skin. We would move the criteria for 
evaluating malignant melanoma in skin from current listing 13.03B to 
proposed new listing 13.29. We would also evaluate malignant melanoma 
in the eye (ocular melanoma) and malignant melanoma in mucous membranes 
(mucosal melanoma) under the proposed listing. This change recognizes 
that malignant melanoma that originates in the eye or mucous membrane 
constitutes an impairment of listing-level severity. We also propose an 
identical listing for evaluating malignant melanoma in children 
(proposed listing 113.29). We currently find all such children disabled 
based on medical equivalence to listing 13.03B.

Other Proposed Changes

    We would make nonsubstantive editorial revisions throughout these 
proposed rules to clarify the introductory text and listings. For 
example, we propose to change the term ``tumor'' to ``cancer'' in the 
sections of the introductory text where it is obvious that the rules 
apply to cancerous tumors. These editorial revisions would also include 
updating the medical terminology in the listings. For example, we would 
replace the term ``Hodgkin's disease'' with the term ``Hodgkin 
lymphoma'' to reflect how the medical community currently refers to 
this cancer.

What specific changes are we proposing to make in the introductory text 
of the listings for evaluating cancer in children?

    We propose to make the following changes to the introductory text 
of the childhood listings that correspond with the changes we are 
proposing for the introductory text of the adult listings:
     Move the definition for ``antineoplastic therapy'' from 
current section 113.00B3 to proposed section 113.00I1.
     Revise the definition of ``persistence'' in proposed 
section 113.00I4 and revise the definition of ``progressive'' in 
proposed section 113.00I5.
     Revise current section 113.00K2b to explain that CML is in 
the accelerated or blast phase if the proportion of blast cells in the 
peripheral blood or bone marrow is 10 percent or greater.
     Remove the word ``ordinarily'' in current section 
113.00K2d.
     Revise current section 113.00K3 to provide more 
information about which solid tumor cancers we evaluate under listing 
113.03 and which we evaluate under other listings in this body system.
     Revise current section 113.00K4 to explain that we 
evaluate primary CNS cancers under listing 113.13.We would

[[Page 76511]]

also list primary CNS cancers that are highly malignant.
     Add guidance in current section 113.00L for evaluating 
cancers treated with bone marrow or stem cell transplantation, 
including transplantation using stem cells from umbilical cord blood.
     Make minor editorial changes to make the child 
introductory text consistent with the adult introductory text.

How do we propose to revise the criteria in the listings for evaluating 
cancer in children?

    We would revise the headings of current listings 113.05 and 113.06 
to indicate that we evaluate all types of lymphoblastic lymphomas (not 
just the T-cell lymphomas) under 113.06. In making this change in the 
headings of the current listings, we would remove the specific 
reference to ``T-cell lymphomas'' in 113.05 and 113.06. We would also 
revise current listing 113.05 for evaluating non-Hodgkin lymphoma (NHL) 
and Hodgkin lymphoma to recognize that these cancers in children 
require treatment regimens that are very toxic and prolonged when they 
have spread to the bone marrow or to visceral organs, such as the 
brain, liver, or lung. With this level of cancer involvement, we would 
consider a child with NHL or Hodgkin lymphoma to be under a disability 
for 24 months from the date of diagnosis without regard to the 
effectiveness of treatment. After that, we would evaluate any residual 
impairment(s) under the criteria for the affected body system. We are 
not proposing similar revisions to current listings 13.05 and 13.06 for 
lymphomas and leukemias in adults. Pediatric lymphomas and leukemias 
behave differently, as they are more aggressive and more difficult to 
treat than most adult lymphomas and leukemias.
    We would also add proposed listing 113.05D that is the same as the 
proposed adult listing for evaluating mantle cell lymphoma.
    We would add proposed listing 113.13C to evaluate cancers of the 
CNS in children that are metastatic. We would also use proposed 113.13C 
to evaluate cancers of the CNS in children that are progressive or 
recurrent following initial antineoplastic therapy. We currently find 
disabled all children with the CNS cancer described in the proposed 
listing based on medical equivalence to current listing 13.13A2.

What is our authority to make rules 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.\4\
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    \4\ Sections 205(a), 702(a)(5), and 1631(d)(1) of the Act.
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How long would these proposed rules be effective?

    If we publish these proposed rules as final rules, they would 
remain in effect for 5 years after the date they become effective, 
unless we extend them, or revise and issue them again.

Clarity of These Proposed Rules

    Executive Order 12866, as supplemented by Executive Order 13563, 
requires each agency to write all rules in plain language. In addition 
to your substantive comments on these proposed rules, we invite your 
comments on how to make them easier to understand.
    For example:
     Would more, but shorter sections be better?
     Are the requirements in the rules clearly stated?
     Have we organized the material to suit your needs?
     Could we improve clarity by adding tables, lists, or 
diagrams?
     What else could we do to make the rules easier to 
understand?
     Do the rules contain technical language or jargon that is 
not clear?
     Would a different format make the rules easier to 
understand, such as grouping and order of sections, use of headings, 
paragraphing?

When will we start to use these rules?

    We will not use these rules until we evaluate public comments and 
publish final rules in the Federal Register. All final rules we issue 
include an effective date. We will continue to use our current rules 
until that date. If we publish final rules, we will include a summary 
of the relevant comments we received, along with responses, and an 
explanation of how we will apply the new rules.

Regulatory Procedures

Executive Order 12866, as Supplemented by Executive Order 13563

    We consulted with the Office of Management and Budget (OMB) and 
determined that these proposed rules meet the criteria for a 
significant regulatory action under Executive Order 12866, as 
supplemented by Executive Order 13563. Therefore, OMB reviewed them.

Regulatory Flexibility Act

    We certify that these proposed rules would not have a significant 
economic impact on a substantial number of small entities because they 
affect individuals only. Therefore, the Regulatory Flexibility Act, as 
amended, does not require us to prepare a regulatory flexibility 
analysis.

Paperwork Reduction Act

    These proposed rules do not create any new, or affect any existing, 
collections and do not require OMB approval under the Paperwork 
Reduction Act.

References

    We consulted the following references when we developed these 
proposed rules:

Brandes, A.B., et al., Adult neuroectodermal tumors of posterior 
fossa (medulloblastoma) and of supratentorial sites (stPNET), 
Critical Reviews in Oncology Hematology, Aug;71(2), 165-179 (2009). 
doi: 10.1016/j.critrevonc.
Chang, D.W., Lymphaticovenular bypass for lymphedema management in 
breast cancer patients: A prospective study, Plastic and 
Reconstructive Surgery, Sep;126(3), 752-758 (2010). doi: 10.1055/s-
0032-1323762.
Chen, C.I., Treatment for Waldenstrom's macroglobulinemia, Annals of 
Oncology, Apr;15(4), 550-558 (2004) (available at: http://annonc.oxfordjournals.org/content/15/4/550.full). doi: 10.1093/
annonc/mdh128.
Chen, J., et al., Incidence, mortality, and prognostic factors of 
small-cell carcinoma of the cervix, Obstetrics & Gynecology, 
Jun;111(6), 1394-1402 (2008). Doi: 10.1097/AOG.0b013e31817370b.
Choueiri, T.K., et al., Impact of postoperative prostate-specific 
antigen disease recurrence and the use of salvage therapy on the 
risk of death, Cancer, Apr;116(8), 1887-1892 (2010) (available at: 
http://onlinelibrary.wiley.com/doi/10.1002/cncr.25013/pdf). doi: 
10.1002/cncr.25013.
Chung, B.I., et al., Comparison of prostate cancer tumor volume and 
percent cancer in prediction of biochemical recurrence and cancer 
specific survival, Urologic Oncology, May-Jun;29(3), 314-318 (2011), 
electronic publication ahead of print available at: http://www.urologiconcology.org/article/S1078-1439(09)00199-9/abstract. 
doi: 10.1016/j.urolonc.2009.06.017.
Collaborative Ocular Melanoma Study Group, The COMS randomized trial 
of iodine 125 brachytherapy for choroidal melanoma: V. Twelve-year 
mortality

[[Page 76512]]

rates and prognostic factors: COMS Report No. 28, Archives of 
Ophthalmology, Dec;124(12), 1684-1693 (2006).
de Alacon, P.A., Pediatric Hodgkin lymphoma treatment and 
management: Management, Medscape, (2011)(available at http://emedicine.medscape.com/article/987101-treatment).
Erickson, V.S., et al., Arm edema in breast cancer patients, Journal 
of the National Cancer Institute, Jan;93(2), 96-111 (2001) 
(available at: http://jnci.oxfordjournals.org/content/93/2/96.full.pdf+html).
Gartner, R., et al., Self-reported arm-lymphedema and functional 
impairment after breast cancer treatment--A nationwide study of 
prevalence and associated factors, The Breast, Dec;19(6), 506-515 
(2010). doi: 10.1016/j.breast.2010.05.015.
Goy, A., et al., Mantle cell lymphoma: The promise of new treatment 
options, Critical Reviews in Oncology/Hematology, Sep;80(1), 69-86 
(2011), electronic publication ahead of print, available at: http://www.croh-online.com/article/PIIS1040842810002167/abstract?rss=yes. 
doi: 10.1016/j.critrevonc.2010.09.003.
Hicks, M.J., et al., Oral mucosal melanoma: Epidemiology and 
pathobiology, Oral Oncology, Mar;36(2), 152-169 (2000).
Jafee, E.S., et al., eds, World Health Organization Classification 
of Tumours: Pathology and Genetics of Tumours of Haematopoietic and 
Lymphoid Tissues, Lyon: IARC Press, (2001).
Johnson, J.M., Pediatric Non-Hodgkin lymphoma treatment and 
management, Medscape, (2011) (available at: http://emedicine.medscape.com/article/987540-treatment#aw2aab6b6b3).
Johnson, J.M., Pediatric Non-Hodgkin lymphoma workup: Staging, 
Medscape, (2011) (available at: http://emedicine.medscape.com/article/987540-workup).
Karkhaneh, R., et al., Long-term surgical outcome of posterior 
choroidal melanoma treated by endoresection, Retina, Sep;27(7), 908-
914 (2007).
Kenney, B., et al., Primary malignant melanoma of the transverse 
colon: Report of a case and review of literature, International 
Journal of Surgical Pathology, Oct;15(4), 401-407 (2007).
Kidd, E.A., et al., Lymph node staging by positron emission 
tomography in cervical cancer: Relationship to prognosis, Journal of 
Clinical Oncology, Apr;28(12), 2108-2113 (2010). doi: 10.1200/
JCO.2009.25.4151.
Kim, J.H., et al., Extrapulmonary small-cell carcinoma: A single-
institution experience, Japanese Journal of Clinical Oncology, 
May;34(5), 250-254 (2004) (available at: http://jjco.oxfordjournals.org/content/34/5/250.full.pdf+html).
Kliegman, R.M., et al., eds., Nelson Textbook of Pediatrics, 
Nineteenth Edition, Philadelphia: Saunders, 2011.
Madan, V., et al., Non-melanoma skin cancer, The Lancet, 
Feb;375(9715), 673-685 (2010). doi: 10.1016/S0140-6736(09)61196-X.
Mansor, S., et al., Borderline ovarian mucinous neoplasm recurring 
as small-cell carcinoma of hypercalcemic type: Evidence for an 
epithelial histogenesis and relationship with ovarian mucinous 
tumors for this enigmatic neoplasm, International Journal of 
Gynecological Pathology, Jul;30(4), 380-385 (2011). doi: 10.1097/
PGP.0b013e318209aebc.
McLean, N., et al., Primary mucosal melanoma of the head and neck. 
Comparison of clinical presentation and histopathologic features of 
oral and sinonasal melanoma, Oral Oncology, Nov;44(11), 1039-1046 
(2008). doi: 10.1016/j.oraloncology.2008.01.014.
Mendenhal, W.M., et al., Head and neck mucosal melanoma, American 
Journal of Clinical Oncology, Dec;28(6), 626-630 (2005) (available 
at: http://oralcancerfoundation.org/facts/pdf/melanoma.pdf).
Mueller, S., et al., Pediatric brain tumors: Current treatment 
strategies for future therapeutic approaches, Neurotherapeutics: The 
Journal of the American Society for Experimental Neurotherapeutics, 
Jul;6(3), 570-586 (2009). doi: 10.1016/j.nurt.2009.
Nofech-Mozes, S., et al., Immunophenotyping of serous carcinoma of 
the female genital tract, Modern Pathology, Sep;21(9), 1147-1155 
(2008) (available at: http://www.nature.com/modpathol/journal/v21/n9/full/modpathol2008108a.html). doi: 10.1038/modpathol.2008.108.
Obrador-Hevia, A., et al., Molecular biology of mantle cell 
lymphoma: From profiling studies to new therapeutic strategies, 
Blood Reviews, Sep;23(5), 205-216 (2009). doi: 10.1016/
j.blre.2009.03.001.
Patrick, R.J., et al., Primary mucosal melanoma, Journal of the 
American Academy of Dermatology, May;56(5), 828-834 (2007).
Pentheroudakis, G., et al., Serous papillary peritoneal carcinoma: 
Unknown primary tumour, ovarian cancer counterpart or distinct 
entity? A systematic review, Critical Reviews in Oncology 
Hematology, Jul;75(1), 27-42 (2010). doi: 10.1016/
j.critrevonc.2009.10.003.
Pizer, B., et al., Treatment of recurrent central nervous system 
primitive neuroectodermal tumours in children and adolescents: 
Results of a Children's Cancer and Leukaemia Group study, European 
Journal of Cancer, Jun;47(9), 1389-1397 (2011). doi: 10.1016/
j.ejca.2011.03.004.
Prasad, M.L., et al., Primary mucosal melanoma of the head and neck: 
A proposal for microstaging localized, stage 1 (lymph node-negative) 
tumors, Cancer, Apr;100(8), 1657-1664 (2004).
Rineer, J., et al., Small-cell carcinoma of the breast, Journal of 
the National Medical Association, Oct;101(10), 1061-1064 (2009).
Sakorafas, G.H., et al., Lymphedema following axillary lymph node 
dissection for breast cancer, Surgical Oncology, Nov;15(3), 153-165 
(2006).
Schefler, A. C., et al., Brachytherapy for uveal melanoma: New 
Developments and controversies, Retinal Physician, (2009) (available 
at: http://www.retinalphysician.com/printarticle.aspx?article=103458).
Sinacki, M., et al., Pattern of care in locally advanced breast 
cancer: Focus on local therapy, The Breast, Apr;20(2), 145-150 
(2011). doi: 10.1016/j.breast.2010.08.008.
Soto, D.E., et al., Limited-stage extrapulmonary small-cell 
carcinoma: Outcomes after modern chemotherapy and radiotherapy, The 
Cancer Journal, Aug;13(4), 243-246 (2007).
Suami, H., et al., Overview of surgical treatments for breast 
cancer-related lymphedema, Plastic and Reconstructive Surgery, 
Dec;126(6), 1853-1863 (2010). doi: 10.1097/PRS.0b013e3181f44658.
Walsh, S.H., et al., Lymphoplasmacytic lymphoma/Waldenstrom's 
macroglobulinemia derives from an extensively hypermutated B cell 
that lacks ongoing somatic hypermutation, Leukemia Research, 
Jul;29(7), 729-734 (2005).
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Plastic Surgery, Oct;59(4), 464-472 (2007).
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The Marsden experience over half a century, Clinical Oncology, 
Jun;15(4), 199-204 (2003).

    We included these references in the rulemaking record for these 
proposed rules and will make them available for inspection by 
interested individuals who make arrangements with the contact person 
above.

(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: December 6, 2013.
Carolyn W. Colvin,
Acting Commissioner of Social Security.

    For the reasons set out in the preamble, we propose to amend 20 CFR 
chapter III part 404 subpart P as set forth below:

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:


[[Page 76513]]


    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 of appendix 1.
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 of appendix 1.
0
d. Amend listing 13.02 of part A of appendix 1 by revising the heading, 
revising current listing 13.02B, deleting current listing 13.02C, 
redesignating current listing 13.02D as 13.02C, and adding new listings 
13.02D and 13.02E.
0
e. Amend listing 13.03 of part A of appendix 1 by revising listing 
13.03B.
0
f. Amend listing 13.05 of part A of appendix 1 by revising listing 
13.05A2, adding listing 13.05A3 and replacing the word ``disease'' with 
the word ``lymphoma'' in listing 13.05B.
0
g. Amend listing 13.06 of part A of appendix 1 by adding a cross-
reference in the first sentence of listing 13.06B1.
0
h. Amend listing 13.10 of part A of appendix 1 by revising 13.10A, 
adding the word ``OR'' after listing 13.10C, and adding listings 13.10D 
and 13.10E.
0
i. Amend listing 13.11 of part A of appendix 1 by replacing the word 
``tumor'' in listing 13.11B with the word ``cancer'' and the word 
``tumors'' in listing 13.11D with the word ``cancers,'' and adding a 
cross-reference to the first sentence of listing 13.11D.
0
j. Amend listing 13.12 of part A of appendix 1 by revising 13.12C.
0
k. Revise listing 13.13 of part A of appendix 1.
0
l. Amend listing 13.14 of part A of appendix 1 by adding a cross-
reference in the first sentence of listing 13.14C.
0
m. Amend listing 13.15 of part A of appendix 1 by adding the word 
``OR'' after listing 13.15B, and adding listing 13.15C.
0
n. Amend listing 13.16 of part A of appendix 1 by adding the word 
``OR'' after listing 13.16B, and adding listing 13.16C.
0
o. Amend listing 13.17 of part A of appendix 1 by adding the word 
``OR'' after listing 13.17B, and adding listing 13.17C.
0
p. Amend listing 13.18 of part A of appendix 1 by adding the word 
``OR'' after listing 13.18C, and adding listing 13.18D.
0
q. Amend listing 13.19 of part A of appendix 1 by replacing the word 
``tumors'' with the word ``cancer.''
0
r. Amend listing 13.20 of part A of appendix 1 by revising listing 
13.20B.
0
s. Amend listing 13.22 of part A of appendix 1 by adding the word 
``OR'' after listing 13.22D, and adding listing 13.22E.
0
t. Amend listing 13.23 of part A of appendix 1 by revising listings 
13.23B and 13.23E, adding the word ``OR'' after listing 13.23E, and 
adding listing 13.23F.
0
u. Amend listing 13.24 of part A of appendix 1 by revising listing 
13.24A, adding the word ``OR'' after listing 13.24B, and adding listing 
13.24C.
0
v. Amend listing 13.25 of part A of appendix 1 by replacing the word 
``tumor'' with the word ``cancer.''
0
w. Amend listing 13.28 of part A of appendix 1 by replacing the phrase 
``malignant neoplastic diseases'' with the word ``cancer.''
0
x. Add listing 13.29 after listing 13.28 of part A of appendix 1.
0
y. Revise section 113.00 of part B of appendix 1.
0
z. Amend listing 113.03 of part B of appendix 1 by changing the phrase 
``2 years'' to the phrase ``24 months'' in listings 113.03A and 
113.03B.
0
aa. Amend listing 113.05 of part B of appendix 1 by revising listings 
113.05A and 113.05B, adding the word ``OR'' after listing 113.05C, and 
adding listing 113.05D.
0
bb. Amend listing 113.06 of part B of appendix 1 by revising the first 
sentence of listing 113.06A and adding a cross-reference to the first 
sentence of listing 113.06B1.
0
cc. Revise listing 113.13 of part B of appendix 1.
0
dd. Add listing 113.29 after listing 113.21 of part B of appendix 1.
    The revisions and additions read as follows:

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

* * * * *
    14. Cancer (Malignant Neoplastic Diseases) (13.00 and 113.00): 
[DATE 5 YEARS AFTER EFFECTIVE DATE OF THE FINAL RULES].
* * * * *

Part A

* * * * *

13.00 Cancer (Malignant Neoplastic Diseases)

* * * * *

13.00 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 
14.08E 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 antineoplastic 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.
    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 13.00G.)
    E. When do we need longitudinal evidence?
    1. Cancer with 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 antineoplastic 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 
antineoplastic 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 
13.00I4.)
    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,

[[Page 76514]]

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 13.00G).
    c. We need evidence under 13.02E, 13.11D, and 13.14C to 
establish that your treating source initiated multimodal 
antineoplastic 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 antineoplastic therapy?
    1. How we consider the effects of antineoplastic 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 antineoplastic 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.
    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 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 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. Antineoplastic therapy means surgery, radiation, 
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.
    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 antineoplastic 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 antineoplastic therapy that is given 
as 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 antineoplastic 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 
antineoplastic 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 antineoplastic 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.

[[Page 76515]]

However, your impairment will not meet the requirements of 13.05A2 
if your therapy is changed solely because you or your 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 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 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 
antineoplastic 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.
    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 (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 
antineoplastic 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 
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.
    13.01 Category of Impairments, Cancer (Malignant Neoplastic 
Diseases)
    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 
antineoplastic therapy, except persistence or recurrence in the true 
vocal cord.
OR
    C. With metastases beyond the regional lymph nodes.
OR
    D. Small-cell (oat cell) carcinoma.
OR
    E. Soft tissue cancers originating in the head and neck treated 
with multimodal antineoplastic therapy (see 13.00E3c). Consider 
under a disability until at least 18 months from the date of 
diagnosis. Thereafter, evaluate any residual

[[Page 76516]]

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).
* * * * *
    13.05 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, 2, or 3:
* * * * *
    2. Indolent lymphoma (including mycosis fungoides and follicular 
small cleaved cell) requiring initiation of more than one (single 
mode or multimodal) antineoplastic 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.
    3. Mantle cell lymphoma.
OR
    B. Hodgkin lymphoma with failure to achieve clinically complete 
remission, or recurrent disease within 12 months of completing 
initial antineoplastic therapy.
* * * * *
    13.06 Leukemia. (See 13.00K2.)
* * * * *
    B. * * *
    1. Accelerated or blast phase (see 13.00K2b).
* * * * *
    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. * * *
OR
    D. Small-cell (oat cell) carcinoma.
OR
    E. With secondary lymphedema that is caused by antineoplastic 
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 
antineoplastic therapy.
* * * * *
    D. All other cancers originating in bone with multimodal 
antineoplastic 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 antineoplastic 
therapy.
OR
    B. Primary peripheral nerve or spinal root cancers, as described 
in 1 or 2:
    1. Metastatic.
    2. Progressive or recurrent following initial antineoplastic 
therapy.
    13.14 Lungs.
* * * * *
    C. Carcinoma of the superior sulcus (including Pancoast tumors) 
with multimodal antineoplastic therapy (see 13.00E3c). 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.
    13.15 Pleura or mediastinum.
* * * * *
    B. * * *
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).
* * * * *
    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 antineoplastic 
therapy.
    3. With metastases to distant (for example, para-aortic or 
supraclavicular) lymph nodes.
* * * * *
    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 antineoplastic therapy.
    2. Germ-cell cancers--progressive or recurrent following initial 
antineoplastic 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 or B:
    A. Recurrent (except an additional primary melanoma at a 
different site, which is not considered to be recurrent disease) 
following either 1, 2, or 3:
    1. Wide excision (skin melanoma).
    2. Enucleation of the eye (ocular melanoma).
    3. Complete surgical excision (mucosal 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.
* * * * *
Part B
* * * * *

113.00 Cancer (Malignant Neoplastic Diseases)

* * * * *

[[Page 76517]]

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 antineoplastic 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. 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, 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, when 
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 is 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 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 
antineoplastic 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 it does not, 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 antineoplastic therapy?
    1. How we consider the effects of 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 antineoplastic 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.
    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 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, at least 12 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 
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?
    1. Antineoplastic therapy means surgery, radiation, 
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.
    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 antineoplastic therapy that is given 
as 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.

[[Page 76518]]

    4. Persistent means the planned initial antineoplastic 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 
antineoplastic therapy.
    6. Recurrent or relapse means a 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 antineoplastic 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, 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), or neuroblastomas (see 113.21) 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.
    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 (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 
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 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, 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 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 antineoplastic 
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 antineoplastic 
therapy.

OR
    C. * * *
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)).

OR
    B. * * *
    1. Accelerated or blast phase (see 113.00K2b).
* * * * *
    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 antineoplastic 
therapy.
* * * * *
    113.29 Malignant melanoma (including skin, ocular, or mucosal 
melanomas), as described in either A or B:
    A. Recurrent (except an additional primary melanoma at a 
different site, which is not

[[Page 76519]]

considered to be recurrent disease) following either 1, 2, or 3:
    1. Wide excision (skin melanoma).
    2. Enucleation of the eye (ocular melanoma).
    3. Complete surgical excision (mucosal 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.
* * * * *
[FR Doc. 2013-30088 Filed 12-16-13; 8:45 am]
BILLING CODE 4191-02-P