67018 Federal Register / Vol. 69, No. 219 / Monday, November 15, 2004 / Rules and Regulations 

SOCIAL SECURITY ADMINISTRATION

20 CFR Part 404 

[Regulations No. 4] 

RIN 0960–AD67 

Revised Medical Criteria for Evaluating 

Malignant Neoplastic Diseases

AGENCY: Social Security Administration.

ACTION: Final rules.

SUMMARY: We are revising the criteria in 

the Listing of Impairments (the listings) 

that we use to evaluate claims involving 

malignant neoplastic diseases. We apply 

these criteria when you claim benefits 

based on disability under title II and 

title XVI of the Social Security Act (the 

Act). The revisions reflect advances in 

medical knowledge, treatment, and 

methods of evaluating malignant 

neoplastic diseases.

DATES: These rules are effective 

December 15, 2004. 

Electronic Version 

The electronic file of this document is 

available on the date of publication in 

the Federal Register at http://

www.gpoaccess.gov/fr/index.html. It is 

also available on the Internet site for 

SSA (i.e., Social Security Online):

http://policy.ssa.gov/pnpublic.nsf/

LawsRegs.

FOR FURTHER INFORMATION CONTACT:

Martin Sussman, Regulations Officer, 

Office of Regulations, Social Security 

Administration, 100 Altmeyer Building, 

6401 Security Boulevard, Baltimore, 

Maryland 21235–6401, (410) 965–1767 

or TTY (410) 966–5609. For information 

on eligibility or filing for benefits, call 

our national toll-free number, 1–800–

772–1213 or TTY 1–800–325–0778, or 

visit our Internet Web site, Social 

Security Online, at http://

www.socialsecurity.gov/.

SUPPLEMENTARY INFORMATION: We are 

revising and making final the rules we 

proposed for evaluating malignant 

neoplastic diseases in the Notice of 

Proposed Rulemaking (NPRM) 

published in the Federal Register on 

November 27, 2001 (66 FR 59306). In 

that NPRM, we proposed revisions to 

both the listings for hematological 

disorders and the listings for malignant 

neoplastic diseases. We proposed to 

make revisions to the listings for these 

two body systems in order to update 

their medical criteria and to provide 

more information about how we 

evaluate disorders in these body 

systems. We initially provided a 60-day 

comment period that ended on January 

28, 2002. Subsequently, on April 18, 

2002, we reopened the comment period 

for an additional 60 days, until June 17, 

2002 (67 FR 19138). For the reasons 

explained below, we have decided to 

publish only revisions to the malignant 

neoplastic diseases body system in this 

final rule. We are publishing separately, 

in today’s edition of the Federal 

Register, a notice withdrawing the 

proposed rules that would have revised 

the hematological disorders listings. We 

plan to publish a new NPRM for the 

hematological disorders listings at a 

later date. 

We provide a summary of the 

provisions of the final rules below, with 

an explanation of the changes we have 

made from the text in the NPRM. We 

then provide summaries of the public 

comments and our reasons for adopting 

or not adopting the recommendations in 

those comments in the section ‘‘Public 

Comments.’’ The final rule language 

follows the public comments section. 

What Programs Do These Final 

Regulations Affect? 

These final regulations affect 

disability determinations and decisions 

that we make under title II and title XVI 

of the Act. In addition, to the extent that 

Medicare entitlement and Medicaid 

eligibility are based on whether you 

qualify for disability benefits under title 

II and title XVI, these final regulations 

also affect the Medicare and Medicaid 

programs. 

Who Can Get Disability Benefits? 

Under title II of the Act, we provide 

for the payment of disability benefits if 

you are disabled and belong to one of 

the following three groups: 

• Workers insured under the Act. 

• Children of insured workers.

• Widows, widowers, and surviving 

divorced spouses (see § 404.336) of 

insured workers. 

Under title XVI of the Act, we provide 

for Supplemental Security Income (SSI) 

payments on the basis of disability if 

you are disabled and have limited 

income and resources. 

How Do We Define Disability? 

Under both the title II and title XVI 

programs, disability must be the result 

of any medically determinable physical 

or mental impairment or combination of 

impairments that is expected to result in 

death or which has lasted or can be 

expected to last for a continuous period 

of at least 12 months. Our definitions of 

disability are shown in the following 

table:

If you file a claim under * * * And you are * * * Disability means you have a medically determinable impairment(s) as 

described above and that results in * * * 

title II ................................................ an adult or a child .......................... the inability to do any substantial gainful activity (SGA). 

title XVI ............................................ an individual age 18 or older ......... the inability to do any SGA. 

title XVI ............................................ an individual under age 18 ............ marked and severe functional limitations. 

How Do We Decide Whether You Are 

Disabled? 

If you are seeking benefits under title 

II of the Act, or if you are an adult 

seeking benefits under title XVI of the 

Act, we use a five-step ‘‘sequential 

evaluation process’’ to decide whether 

you are disabled. We describe this fivestep process in our regulations at 

§§ 404.1520 and 416.920. We follow the 

five steps in order and stop as soon as 

we can make a determination or 

decision. The steps are: 

1. Are you working and is the work 

you are doing substantial gainful 

activity? If you are working and the 

work you are doing is substantial 

gainful activity, we will find that you 

are not disabled, regardless of your 

medical condition or your age, 

education, and work experience. If you 

are not, we will go on to step 2. 

2. Do you have a ‘‘severe’’ 

impairment? If you do not have an 

impairment or combination of 

impairments that significantly limits 

your physical or mental ability to do 

basic work activities, we will find that 

you are not disabled. If you do, we will 

go on to step 3. 

3. Do you have an impairment(s) that 

meets or medically equals the severity 

of an impairment in the listings? If you 

do, and the impairment(s) meets the 

duration requirement, we will find that 

you are disabled. If you do not, we will 

go on to step 4. 

4. Do you have the residual functional 

capacity to do your past relevant work? 

If you do, we will find that you are not 

disabled. If you do not, we will go on 

to step 5. 

5. Does your impairment(s) prevent 

you from doing any other work that 

exists in significant numbers in the

Federal Register / Vol. 69, No. 219 / Monday, November 15, 2004 / Rules and Regulations 67019

national economy, considering your 

residual functional capacity, age, 

education, and work experience? If it 

does, and it meets the duration 

requirement, we will find that you are 

disabled. If it does not, we will find that 

you are not disabled. 

We use a different sequential 

evaluation process for children who 

apply for payments based on disability 

under title XVI of the Act. We describe 

that sequential evaluation process in 

§ 416.924 of our regulations. If you are 

already receiving benefits, we also use 

a different sequential evaluation process 

when we decide whether your disability 

continues. See §§ 404.1594, 416.924, 

416.994, and 416.994a of our 

regulations. However, all of these 

processes include steps at which we 

consider whether your impairment 

meets or medically equals one of our 

listings. 

What Are the Listings? 

The listings are examples of 

impairments that we consider severe 

enough to prevent you as an adult from 

doing any gainful activity. If you are a 

child seeking SSI benefits based on 

disability, the listings describe 

impairments that we consider severe 

enough to result in marked and severe 

functional limitations. Although the 

listings are contained only in appendix 

1 to subpart P of part 404 of our 

regulations we incorporate them by 

reference in the SSI program in 

§ 416.925 of our regulations, and apply 

them to claims under both title II and 

title XVI of the Act. 

How Do We Use the Listings? 

The listings are in two parts. There 

are listings for adults (part A) and for 

children (part B). If you are an 

individual age 18 or over, we apply the 

listings in part A when we assess your 

claim, and we do not use the listings in 

part B. 

If you are an individual under age 18, 

we first use the criteria in part B of the 

listings. If the listings in part B do not 

apply, and the specific disease 

process(es) has a similar effect on adults 

and children, we then use the criteria in 

part A. (See §§ 404.1525 and 416.925.) 

If your impairment(s) does not meet 

any listing, we will also consider 

whether it medically equals any listing; 

that is, whether it is as medically severe 

as an impairment in the listings. (See

§§ 404.1526 and 416.926.) 

What if You Do Not Have an 

Impairment(s) That Meets or Medically 

Equals a Listing?

We use the listings only to decide that 

individuals are disabled or that they are 

still disabled. We will not deny your 

claim because your impairment(s) does 

not meet or medically equal a listing. If 

you are not doing work that is 

substantial gainful activity, and you 

have a severe impairment(s) that does 

not meet or medically equal any listing, 

we may still find you disabled based on 

other rules in the ‘‘sequential evaluation 

process’’ described above. Likewise, we 

will not decide that your disability has 

ended only because your impairment(s) 

does not meet or medically equal a 

listing. 

Also, when we conduct reviews to 

determine whether your disability 

continues, we will not find that your 

disability has ended because we have 

changed a listing. Our regulations 

explain that, when we change our 

listings, we continue to use our prior 

listings when we review your case, if 

you had qualified for disability benefits 

or SSI payments based on our 

determination or decision that your 

impairment(s) met or medically equaled 

a listing. In these cases, we determine 

whether you have experienced medical 

improvement, and if so, whether the 

medical improvement is related to the 

ability to work. If your condition(s) has 

medically improved so that you no 

longer meet or medically equal the prior 

listing, we evaluate your case further to 

determine whether you are currently 

disabled. We may find that you are 

currently disabled, depending on the 

full circumstances of your case. See

§§ 404.1594(c)(3)(i) and 

416.994(b)(2)(iv)(A). If you are a child 

who is eligible for SSI payments, we 

follow a similar rule when we decide 

whether you have experienced medical 

improvement in your condition(s). See

§ 416.994a(b)(2). 

Why Are We Revising the Listings for 

Malignant Neoplastic Diseases? 

We are revising these listings to 

update our medical criteria for 

evaluating malignant neoplastic 

diseases and to provide more 

information about how we evaluate 

such diseases. On April 24, 2002, we 

published final rules in the Federal 

Register (67 FR 20018) that included 

technical revisions to some of the 

listings for malignant neoplastic 

diseases. Prior to this, we last published 

final rules making comprehensive 

revisions to the listings for malignant 

neoplastic diseases in the Federal 

Register on December 6, 1985 (50 FR 

50068). Because we have not 

comprehensively revised the listings for 

this body system since 1985, we believe 

that we need to update the rules. 

What Do We Mean by ‘‘Final Rules’’ 

and ‘‘Prior Rules’’? 

Even though these rules will not go 

into effect until 30 days after 

publication of this notice, for clarity, we 

refer to the changes we are making here 

as the ‘‘final rules’’ and to the rules that 

will be changed by these final rules as 

the ‘‘prior rules.’’

When Will We Start To Use These Final 

Rules? 

We will start to use these final rules 

on their effective date. We will continue 

to use our prior rules until the effective 

date of these final rules. When the final 

rules become effective, we will apply 

them to new applications filed on or 

after the effective date of these rules and 

to claims pending before us, as we 

describe below. 

As is our usual practice when we 

make changes to our regulations, we 

will apply these final rules on or after 

their effective date when we make a 

determination or decision, including 

those claims in which we make a 

determination or decision after remand 

to us from a Federal court. With respect 

to claims in which we have made a final 

decision, and that are pending judicial 

review in Federal court, we expect that 

the court’s review of the 

Commissioner’s final decision would be 

made in accordance with the rules in 

effect at the time of the administrative 

law judge’s (ALJ) decision, if the ALJ’s 

decision is the final decision of the 

Commissioner. If the court determines 

that the Commissioner’s final decision 

is not supported by substantial 

evidence, or contains an error of law, we 

would expect that the court would 

reverse the final decision, and remand 

the case for further administrative 

proceedings pursuant to the fourth 

sentence of section 205(g) of the Act, 

except in those few instances in which 

the court determines that it is 

appropriate to reverse the final decision 

and award benefits without remanding 

the case for further administrative 

proceedings. In those cases decided by 

a court after the effective date of the 

rules, where the court reverses the 

Commissioner’s final decision and 

remands the case for further 

administrative proceedings, on remand, 

we will apply the provisions of these 

final rules to the entire period at issue 

in the claim. 

How Long Will These Final Rules Be 

Effective? 

These rules will no longer be effective 

5 years after the date on which they 

become effective, unless we extend 

them or revise and issue them again.

67020 Federal Register / Vol. 69, No. 219 / Monday, November 15, 2004 / Rules and Regulations 

Why Are We Not Publishing Final 

Rules for Evaluating Hematological 

Disorders in This Notice? 

The public comments we received on 

the NPRM raised significant issues 

about the proposed listings for some of 

the hematological disorders, and we 

have not finished resolving these issues. 

The public comments did not raise 

similar issues with respect to the 

listings for malignant neoplastic 

diseases. Therefore, we are issuing these 

final regulations to implement changes 

to the listings for malignant neoplastic 

diseases, and we summarize and 

respond here only to the significant 

public comments that we received about 

the proposed changes regarding those 

diseases. 

As noted above, we are publishing 

separately in today’s edition of the 

Federal Register a notice withdrawing 

the proposed rules for the hematological 

disorders listings. We plan to issue a 

new NPRM for the hematological 

disorders listings at a later date. 

What General Changes Are We Making 

That Affect Both the Adult and 

Childhood Listings for Malignant 

Neoplastic Diseases?

To present the listings in a more 

logical order, and make them easier to 

use, we are: 

• Redesignating the listings in part A 

and part B. To the extent possible, the 

listings in part B correspond with 

listings addressing the same or similar 

impairments in part A. 

• Placing all listings for malignant 

neoplastic diseases in this body system, 

with the exception of certain ones 

associated with human 

immunodeficiency virus (HIV) 

infection. To do this, we are moving the 

criteria for acute leukemia, chronic 

leukemia, myeloma, and malignant 

brain tumors, prior listings 7.11, 7.12, 

7.16, 11.05, 107.11, and 111.05, to final 

listings 13.06, 13.07, 13.13, 113.06 and 

113.13, respectively. We are also 

moving the guidance for evaluating 

macroglobulinemia or heavy chain 

disease, prior listing 7.14, to 13.00K3 of 

the introductory text because the prior 

listing for this disorder was a reference 

listing. As noted below, we are 

eliminating reference listings and 

providing guidance in the introductory 

text. 

• Removing reference listings from 

this body system. Reference listings are 

listings that are met by satisfying the 

criteria of another listing. For example, 

prior listing 7.16B, for myeloma with 

evidence of renal impairment, was a 

reference listing that requires evaluation 

under listing 6.02, for impairment of 

renal function. Instead of using 

reference listings, we are providing 

guidance in the introductory text stating 

that these impairments should be 

evaluated under the criteria for the 

affected body system. Where 

appropriate, we also provide references 

to specific listings. For example, in 

13.00K3 we indicate that 

macroglobulinemia or heavy chain 

disease should be evaluated under the 

criteria of 7.02, 7.06, or 7.08, or under 

the criteria of any other affected body 

system. 

How Are We Changing the Introductory 

Text to the Listings for Evaluating 

Malignant Neoplastic Diseases in 

Adults? 

13.00 Malignant Neoplastic Diseases 

We are expanding and reorganizing 

the introductory text to these listings to 

provide additional guidance and reflect 

the new listings. The following is a 

detailed explanation of this material. 

13.00A—What Impairments Do These 

Listings Cover? 

In this section, we explain that we use 

these listings to evaluate all malignant 

neoplasms, except certain neoplasms 

associated with human 

immunodeficiency virus (HIV) 

infection. We use the criteria in listing 

14.08E to evaluate carcinoma of the 

cervix, Kaposi’s sarcoma, lymphoma, 

and squamous cell carcinoma of the 

anus if you also have HIV infection. 

13.00B—What Do We Consider When 

We Evaluate Malignant Neoplastic 

Diseases Under These Listings? 

This section corresponds to prior 

13.00A, ‘‘Introduction.’’ For clarity, we 

are using the phrase ‘‘origin of the 

malignancy’’ instead of the prior 

language, ‘‘the site of the lesion, the 

histogenesis of the tumor’’ to describe 

one of the factors we consider when we 

evaluate malignant neoplastic diseases. 

We also changed the phrase ‘‘apparent 

adequacy and response to therapy’’ in 

the prior section to ‘‘[r]esponse to 

antineoplastic therapy’’ to eliminate any 

misunderstanding concerning who can 

make judgments about the 

appropriateness of the treatment 

regimen. ‘‘Apparent adequacy’’ was 

intended to mean effectiveness of the 

therapy. Judgments about its 

appropriateness must be left entirely to 

the treating source. We added the word 

‘‘antineoplastic’’ to be consistent with 

the language in the listing criteria. We 

also specifically identify the types of 

antineoplastic therapy referred to in the 

listings. 

13.00C—How Do We Apply the Listings? 

In this section, we explain that we 

apply the criteria in a specific listing to 

a malignancy originating from that 

specific site. 

In this section of the NPRM (66 FR at 

59321), we stated that metastatic 

carcinoma to the brain or spinal cord 

was an exception to the guidance above. 

We received a public comment 

questioning this exception. In response 

to this comment, we determined that 

this exception was unnecessary and 

have removed it. We will evaluate 

metastatic carcinoma to the brain or 

spinal cord under the site of origin for 

the primary tumor or, if this is 

unknown, under final listing 13.27. 

13.00D—What Evidence Do We Need? 

We are expanding the guidance in 

prior 13.00B, ‘‘Documentation,’’ by: 

• Explaining that when the primary 

site cannot be identified, we will use 

evidence documenting the site(s) of 

metastasis to evaluate the impairment 

under listing 13.27. 

• Clarifying that we consider biopsies 

and needle aspirations to be ‘‘operative 

procedures.’’

• Using the more general term 

‘‘pathology report’’ instead of ‘‘the 

report of the gross and microscopic 

examination of the surgical specimen.’’

We made this change to recognize that 

a report of the gross examination is not 

always required and to recognize that a 

microscopic examination of appropriate 

body fluids may be used as an 

alternative to the gross and microscopic 

examination of the surgical specimen. 

13.00E—When Do We Need 

Longitudinal Evidence? 

We are incorporating and expanding 

the guidance in the fourth paragraph of 

prior 13.00C, ‘‘Evaluation.’’ We explain 

when we need longitudinal evidence, 

and the time period such evidence 

should cover. We also explain when we 

may need to defer adjudication. 

13.00F—How Do We Evaluate 

Impairments That Do Not Meet One of 

the Malignant Neoplastic Diseases 

Listings? 

This paragraph corresponds to the 

first sentence in the second paragraph of 

prior 13.00D, ‘‘Effects of Therapy.’’ We 

state our basic adjudicative principle 

that, if your impairment(s) does not 

meet or medically equal the 

requirements of a listing, we will 

continue the sequential evaluation 

process to determine whether you are 

disabled.

Federal Register / Vol. 69, No. 219 / Monday, November 15, 2004 / Rules and Regulations 67021

13.00G—How Do We Consider the 

Effects of Therapy? 

We are reorganizing the guidance in 

prior 13.00D, ‘‘Effects of Therapy.’’ In 

final 13.00G2a, we are adding ‘‘extent of 

surgery’’ and ‘‘schedule and fields of 

radiation therapy’’ to the list of the 

elements of therapy for which we will 

request a description noted in the 

second paragraph of prior 13.00D. In 

final 13.00G2b, we are adding 

‘‘neurological complications’’ and 

‘‘cardiovascular complications’’ to the 

list of examples of complications or 

adverse effects for which we will 

request a description. We are also 

clarifying that we will not delay 

adjudication to determine whether the 

therapy has achieved its intended effect 

if we can make a fully favorable 

determination or decision based on the 

evidence in the case record.

13.00H—How Long Do We Consider 

Your Impairment To Be Disabling? 

We are incorporating and expanding 

the guidance contained in the third 

paragraph of prior 7.00E, ‘‘Acute 

leukemia,’’ and the fifth paragraph of 

prior 13.00C, ‘‘Evaluation.’’ In some of 

the listings, we specify that we consider 

an impairment to be disabling until a 

particular point in time; for example, at 

least 18 months from the date of 

diagnosis. If you have an impairment(s) 

that meets or equals a listing in this 

body system that does not contain such 

a specification, we provide that we will 

consider the impairment(s) to be 

disabling until at least 3 years after 

onset of complete remission. We also 

explain what we do when the 

appropriate time period has passed. 

For those listings in which we specify 

that the impairment is considered 

disabling until a particular point in 

time, such as listing 13.28, the 

beginning date specified is not related to 

the onset date. We can establish an 

earlier onset date if the evidence in your 

case record supports the earlier onset 

date, as we explain in final 13.00J. 

13.00I—What Do These Terms in the 

Listings Mean? 

We are revising the first two 

paragraphs and the first sentence of the 

third paragraph of prior 13.00C, 

‘‘Evaluation,’’ and providing additional 

definitions. The prior section contained 

an adjudicative definition of ‘‘distant 

metastases’’ and ‘‘metastases beyond the 

regional lymph nodes.’’ We are not 

retaining this definition because our use 

of these terms in the final listings is 

consistent with current clinical practice. 

We are also adding definitions in order 

to differentiate between the terms 

‘‘inoperable’’ and ‘‘unresectable.’’

13.00J—Can We Establish the Existence 

of a Disabling Impairment Prior to the 

Date of the Evidence That Shows the 

Malignancy Satisfies the Criteria of a 

Listing? 

This section corresponds to prior 

13.00E, ‘‘Onset.’’ We are making no 

substantive changes. 

13.00K—How Do We Evaluate Specific 

Malignant Neoplastic Diseases? 

We are incorporating and clarifying 

prior 7.00E, ‘‘Acute leukemia,’’ and the 

last sentence of the third paragraph in 

prior 13.00C, ‘‘Evaluation,’’ and 

providing guidance for evaluating 

additional malignant neoplastic 

disorders. The following is a detailed 

discussion of the information provided. 

13.00K1—Lymphoma 

In paragraphs K1a and K1b of this 

section, we discuss the evaluation of 

low grade or indolent (non-aggressive) 

lymphomas. We explain that we may 

defer adjudication of these cases for an 

appropriate period after the initiation of 

therapy to determine whether the 

therapy will achieve its intended effect. 

We do not specify a particular time for 

this deferral because it will vary from 

case to case. We also explain that 

changes in therapy based solely on 

patient or physician preference are not 

indicative of a failure to stabilize the 

disease. We also explain how the 

disease should be evaluated when 

stability has been achieved. 

Final paragraphs 13.00K1a and 

13.00K1b reflect nonsubstantive 

editorial corrections made to the 

corresponding proposed paragraphs in 

the NPRM (66 FR at 59322). Proposed 

paragraph K1a referred to indolent 

lymphoma. We added a reference to low 

grade lymphoma to final paragraph K1a 

to be consistent with the listing 

language. We also added a reference to 

low grade or indolent lymphoma in 

final paragraph K1b for clarity. 

We have not retained the last sentence 

of the third paragraph of prior 13.00C, 

‘‘Evaluation.’’ This sentence stated, ‘‘In 

the evaluation of lymphomas, the tissue 

type and site of involvement are not 

necessarily indicators of the degree of 

impairment.’’ We do not believe this 

guidance provided useful information 

for applying the criteria in final listing 

13.05. 

In paragraph K1c, we provide that 

Hodgkin’s disease that recurs more than 

12 months after completing initial 

antineoplastic therapy will be evaluated 

as a new disease rather than as a 

recurrence. 

13.00K2—Leukemia 

In paragraph K2a, we expand the 

guidance in the first paragraph of prior 

7.00E, ‘‘Acute leukemia,’’ to indicate 

sources of additional diagnostic 

information. We clarify that recurrent 

disease must be documented by 

peripheral blood, bone marrow, or 

cerebrospinal fluid examination. We 

also clarify that the initial and followup pathology reports should be 

included. 

In paragraph K2b, we provide 

guidance on documenting chronic 

myelogenous leukemia (CML). We have 

not included in this paragraph the 

guidance in the second paragraph of 

prior 7.00E, which provided that the 

acute phase of CML should be 

considered under the requirements for 

acute leukemia. Instead, we have 

provided a separate listing for the acute 

phase (more appropriately called the 

accelerated or blast phase) of CML, final 

listing 13.06B1, that uses the same 

criteria as the listing for acute leukemia 

(final listing 13.06A). 

In paragraph K2c, we provide 

guidance for documenting and 

evaluating chronic lymphocytic 

leukemia (CLL). Consistent with our 

effort to eliminate reference listings, this 

guidance incorporates the crossreferences from prior listing 7.12 that 

are appropriate for evaluating CLL.

In paragraph K2d, we explain that, in 

cases of chronic leukemia (either 

myelogenous or lymphocytic), an 

elevated white cell count, in itself, is 

not ordinarily a factor in determining 

the severity of the impairment. 

13.00K3—Macroglobulinemia or Heavy 

Chain Disease 

This section replaces prior listing 

7.14, which was a reference listing. We 

are making no substantive changes in 

how we evaluate these disorders. 

13.00K4—Bilateral Primary Breast 

Cancer 

We are clarifying the statement in 

prior listing 13.09D, ‘‘bilateral breast 

carcinoma, synchronous or 

metachronous is usually primary in 

each breast’’ (emphasis added) by 

removing the suggestion that there are 

exceptions to this rule. See the 

discussion of final listing 13.10B, below. 

13.00K5—Carcinoma-in-situ 

In this section, we explain that this 

type of carcinoma usually responds to 

treatment and is not included when we 

use the term ‘‘carcinoma’’ in these 

listings.

67022 Federal Register / Vol. 69, No. 219 / Monday, November 15, 2004 / Rules and Regulations 

13.00K6—Brain Tumors 

In this section, we explain that 

malignant tumors are evaluated under 

final listing 13.13, while benign tumors 

continue to be evaluated under listing 

11.05. We also explain that we evaluate 

any complications of malignant brain 

tumors, such as resultant neurological 

or psychological impairments, under the 

criteria for the affected body system. 

13.00L—How Do We Evaluate 

Malignant Neoplastic Diseases Treated 

by Bone Marrow or Stem Cell 

Transplantation? 

In paragraphs L1 and L2, we discuss 

how long we consider you disabled if 

you have leukemia, lymphoma, or 

multiple myeloma and you undergo 

bone marrow or stem cell 

transplantation. 

In paragraph L3, we provide that any 

other malignant neoplastic diseases 

treated with bone marrow or stem cell 

transplantation must be evaluated under 

final listing 13.28, regardless of whether 

there is another listing that addresses 

that impairment. We explain that under 

final listing 13.28, the length of time we 

will consider you disabled will depend 

on whether you undergo allogeneic or 

autologous transplantation. We also 

define ‘‘allogeneic’’ and ‘‘autologous’’ in 

paragraphs L3a and L3b. 

In paragraph L4, we discuss some of 

the factors we consider when we 

evaluate any residual impairment(s) that 

results from transplantation. 

How Are We Changing the Listings for 

Evaluating Malignant Neoplastic 

Diseases in Adults? 

13.01—Category of Impairments, 

Malignant Neoplastic Diseases 

We are removing prior listing 13.15, 

‘‘Abdomen,’’ because disorders covered 

by this listing can be evaluated under 

other final listings. Prior listings 13.15A, 

‘‘Generalized carcinomatosis,’’ and 

13.15C, ‘‘Ascites with demonstrated 

malignant cells,’’ represent 

malignancies that have spread to the 

abdomen from another site. We will 

evaluate these conditions under final 

listing 13.27, ‘‘Primary site unknown 

after appropriate search for primary.’’

We will evaluate ‘‘Retroperitoneal 

cellular sarcoma not controlled by 

prescribed therapy,’’ the impairment in 

prior listing 13.15B, under final listing 

13.04, ‘‘Soft tissue sarcoma.’’

In the final listings, we: 

• Take into account medical advances 

in the detection, treatment, control, and 

cure of malignant neoplastic diseases. 

• Recognize that in some situations 

the effects of therapy for these disorders 

can be disabling. 

• Provide for the evaluation of 

residual impairments. 

The following is a detailed 

explanation of the final listings. 

Listing 13.02—Soft Tissue Tumors of the 

Head and Neck (Except Salivary 

Glands—13.06—and Thyroid Gland—

13.07) 

This listing corresponds to prior 

listing 13.02, ‘‘Head and neck.’’ We are 

revising the listing heading to ensure 

that only tumors of the soft tissue of the 

head and neck are considered under this 

listing. This change allows us to delete 

the last two exceptions in the prior 

heading (orbit or temporal fossa), as 

these are not soft tissue tumors. In 

response to a comment, we are also 

removing prior listing 13.02E, 

‘‘Epidermoid carcinoma occurring in the 

pyriform sinus or posterior third of the 

tongue,’’ as these conditions can be 

evaluated under other sections of the 

final listing. We had proposed to 

evaluate epidermoid carcinoma 

occurring in the pyriform sinus under 

proposed listing 13.02E. We explain our 

reasons for this change in more detail in 

the public comments section of this 

preamble. 

Final listing 13.02A is substantively 

the same as prior listing 13.02A. We are 

updating the terminology to reflect the 

definitions used in the final listings.

In final listing 13.02B, which 

corresponds to prior listing 13.02B, we 

are replacing ‘‘[n]ot controlled by 

prescribed therapy’’ with ‘‘[p]ersistent 

disease following initial multimodal 

antineoplastic therapy’’ to clarify our 

intent. 

Final listing 13.02C corresponds to 

prior listing 13.02C. We are replacing 

‘‘after radical surgery or irradiation’’

with ‘‘following initial antineoplastic 

therapy’’ to recognize that other 

therapeutic modalities may be used. We 

are also excluding local vocal cord 

recurrences, because these recurrences 

have a good response to therapy. 

Final listing 13.02D corresponds to 

prior listing 13.02D. We are making no 

substantive change. 

Final listing 13.02E corresponds to 

proposed listing 13.02F in the NPRM. 

As we have already noted, we removed 

prior and proposed listing 13.02E in 

response to a comment. Therefore, we 

are redesignating proposed listing 

13.02F as final listing 13.02E. It 

recognizes the length and debilitating 

effects of multimodal treatment for soft 

tissue tumors of the head and neck. 

Listing 13.03—Skin 

We are combining prior listing 13.03, 

‘‘Sarcoma of skin,’’ and prior listing 

13.05, ‘‘Malignant melanoma,’’ so that 

all malignancies originating in the skin 

are evaluated under this listing. 

Accordingly, we are revising the 

heading by removing the reference to 

sarcoma. 

Final listing 13.03A corresponds to 

prior listing 13.03A, ‘‘Angiosarcoma 

with metastases to regional lymph 

nodes or beyond.’’ We are expanding 

the provision to include all skin 

sarcomas and carcinomas because other 

skin malignancies of the severity 

described would also be disabling. 

Final listing 13.03B corresponds to 

prior listing 13.05. We clarify that an 

additional primary melanoma at a 

different site is not considered recurrent 

disease. We are also adding a criterion 

for palpable nodal metastases. Prior 

listing 13.05B addressed only 

metastases to the regional lymph nodes 

or beyond, and not palpable nodal 

metastases. 

We are moving prior listing 13.03B, 

‘‘Mycosis fungoides’’ (a type of 

lymphoma), to final listing 13.05, 

‘‘Lymphoma,’’ so that all lymphomas 

will be evaluated under the same listing. 

Listing 13.04—Soft Tissue Sarcoma 

We are updating the heading of prior 

listing 13.04, ‘‘Sarcoma of soft parts,’’ to 

recognize that ‘‘soft tissue’’ is a more 

common term than ‘‘soft parts.’’ We are 

adding a criterion for regional or distant 

metastases, final listing 13.04A, to be 

consistent with the criteria for other 

malignant neoplastic diseases and to 

recognize the grave prognosis for these 

conditions. In final listing 13.04B, we 

define the prior criterion ‘‘not 

controlled by prescribed therapy’’

similarly to the way we defined it in 

other listings, such as final listing 

13.02B. 

Listing 13.05—Lymphoma (Including 

Mycosis Fungoides, But Excluding T-cell 

Lymphoblastic Lymphoma—13.06) 

This listing corresponds to prior 

listing 13.06. We are changing the 

heading from ‘‘Lymph nodes’’ to 

‘‘Lymphoma’’ to more accurately reflect 

the disease. We also provide a crossreference to the explanatory paragraphs 

in 13.00K1 and 13.00K2c. This listing 

also replaces prior listing 7.13, 

‘‘Lymphomas.’’

We evaluated both Hodgkin’s disease 

and non-Hodgkin’s lymphoma under 

prior listing 13.06A. We are separating 

and clarifying the criteria for each of 

these diseases. Final listing 13.05A 

provides criteria for evaluating nonHodgkin’s lymphoma; final listing 

13.05B provides criteria for Hodgkin’s 

disease. For each of these disorders, we 

clarify the prior criteria by replacing the 

phrase ‘‘progressive disease not

Federal Register / Vol. 69, No. 219 / Monday, November 15, 2004 / Rules and Regulations 67023

controlled by prescribed therapy’’ in the 

prior listing with clearer language. 

In the final rules, we are making a 

minor editorial revision to proposed 

listing 13.05A2 for clarity. We amended 

the proposed listing by adding the 

words ‘‘at least’’ between ‘‘from’’ and 

‘‘the’’ in the last sentence to clarify that 

the individual can be found disabled 

prior to the date specified in the listing. 

In final listing 13.05C, we provide 

that a lymphoma treated by bone 

marrow or stem cell transplantation is 

considered disabling until at least 12 

months from the date of transplantation. 

After this period, we will evaluate any 

residual impairment(s) under the 

criteria for the affected body system. 

We are removing prior listing 13.06B, 

‘‘Metastatic carcinoma in a lymph node 

(except for epidermoid carcinoma in a 

lymph node in the neck) where the 

primary site is not determined after 

adequate search.’’ We will evaluate this 

impairment under final listing 13.27, 

‘‘Primary site unknown after 

appropriate search for primary.’’ We are 

also removing prior listing 13.06C. We 

will evaluate epidermoid carcinoma in 

a lymph node in the neck under final 

listing 13.02, ‘‘Soft tissue tumors of the 

head and neck.’’

Listing 13.06—Leukemia

This final listing replaces prior listing 

7.11, ‘‘Acute leukemia,’’ and prior 

listing 7.12, ‘‘Chronic leukemia.’’

Final listing 13.06A replaces prior 

listing 7.11. We provide that acute 

leukemia (including T-cell 

lymphoblastic lymphoma) will be 

considered disabling until at least 24 

months from the date of diagnosis or 

relapse, or at least 12 months from the 

date of bone marrow or stem cell 

transplantation, whichever is later. After 

the appropriate period, we will evaluate 

any residual impairment(s) under the 

criteria for the affected body system. 

Under the prior listing, we considered 

acute leukemia disabling for 21⁄2 years 

from the time of the initial diagnosis. 

We are shortening this period to 2 years 

because of improvement in the 

treatment of this disorder. However, as 

with other final listings, and unlike the 

prior listing, we permit a longer period 

when the facts warrant it. We also 

recognize that a relapse of acute 

leukemia is as significant as the initial 

diagnosis. 

The criterion for bone marrow or stem 

cell transplantation in cases of acute 

leukemia is similar to the 

transplantation criteria for other 

diseases. Unlike those diseases, 

however, we will not reevaluate cases of 

acute leukemia 12 months after 

transplantation if that date is earlier 

than 24 months after onset or relapse. 

We provide this option for this disease 

because of the disease course and the 

high rate of infection and other 

complications that occur when this 

disease is treated with bone marrow or 

stem cell transplantation. 

Final listing 13.06B, ‘‘Chronic 

myelogenous leukemia,’’ replaces prior 

listing 7.12. The prior listing was a 

reference listing. Rather than replace the 

entire listing with guidance in the 

preface, we are providing separate 

evaluation criteria for CML. Consistent 

with our guidance in the second 

paragraph of prior 7.00E, the listing for 

the accelerated or blast phase of CML is 

the same as final listing 13.06A. 

We are retaining references to the 

listings that are appropriate for 

evaluating chronic lymphocytic 

leukemia in 13.00K2c. 

Listing 13.07—Multiple Myeloma 

(Confirmed by Appropriate Serum or 

Urine Protein Electrophoresis and Bone 

Marrow Findings) 

This listing replaces prior listing 7.16. 

In this listing, we remove the specific 

findings in prior listings 7.16A–D and 

substitute the criterion ‘‘[f]ailure to 

respond or progressive disease 

following initial antineoplastic 

therapy.’’ Our intent is to clarify that 

this listing includes all listing-level 

manifestations of this disease. We also 

clarify that we consider multiple 

myeloma treated with bone marrow or 

stem cell transplantation to be disabling 

until at least 12 months from the date 

of transplantation. After that time, we 

will evaluate any residual impairment(s) 

under the criteria for the affected body 

system. 

Listing 13.08—Salivary Glands 

This listing redesignates prior listing 

13.07. There are no substantive changes. 

Listing 13.09—Thyroid Gland 

In the NPRM, we proposed to amend 

current listing 13.08, for malignancies of 

the thyroid gland, by: 

• Redesignating the current listing as 

proposed listing 13.09. 

• Adding a separate criterion for 

anaplastic (undifferentiated) carcinoma 

in proposed listing 13.09A. 

• Redesignating the criterion in 

current listing 13.08, ‘‘carcinoma with 

metastases beyond the regional lymph 

nodes, not controlled by prescribed 

therapy,’’ as proposed listing 13.09B. 

• Replacing the term ‘‘not controlled 

by prescribed therapy’’ used in current 

listing 13.08 with ‘‘progressive despite 

radioactive iodine therapy’’ to clarify 

our intent. 

On April 24, 2002, we published final 

rules in the Federal Register (67 FR 

20018, 20026) that made technical 

revisions to the listings. Those rules 

added the criterion for anaplastic 

(undifferentiated) carcinoma and 

redesignated the criterion in prior 

listing 13.08 as final listing 13.08B.

In these final rules, we are 

redesignating prior listing 13.08 as final 

listing 13.09, and are clarifying the 

language as indicated in the fourth 

bullet above. 

Listing 13.10—Breast 

This listing corresponds to prior 

listing 13.09. In final listing 13.10A, we 

are amending the criterion in prior 

listing 13.09B, ‘‘Inflammatory 

carcinoma,’’ by adding other types of 

locally advanced carcinoma. 

In final listing 13.10B, ‘‘Carcinoma 

with distant metastases,’’ we are 

revising prior listing 13.09D by 

removing the parenthetical statement 

‘‘bilateral breast carcinoma, 

synchronous or metachronous, is 

usually primary in each breast.’’ Instead, 

we provide guidance about evaluating 

bilateral breast cancer in final 13.00K4. 

As indicated in our discussion of that 

section, we are clarifying this guidance 

by removing the suggestion that there 

are exceptions to this rule. 

In final listing 13.10C, which replaces 

prior listing 13.09C, we are replacing 

the term ‘‘controlled by prescribed 

therapy’’ used in the prior listing with 

‘‘that remits with antineoplastic 

therapy’’ to clarify our intent. 

We are removing prior listing 13.09A, 

‘‘inoperable carcinoma,’’ to avoid 

confusion about what this term means 

for this malignancy. We can evaluate 

cases in which breast cancer is 

inoperable under other criteria in final 

listing 13.10. We are also removing prior 

listing 13.09E, ‘‘Sarcoma with 

metastases anywhere.’’ We will evaluate 

this impairment under final listing 

13.04, ‘‘Soft tissue sarcoma.’’ 

Listing 13.11—Skeletal System 

This listing replaces prior listing 

13.10. We are expanding the listing to 

include tumors of the mandible that 

were evaluated under prior listing 

13.11. In final listings 13.11A, 13.11B, 

and 13.11C, we revise prior listing 

13.10A to clarify when these tumors are 

of listing-level severity. In final listing 

13.11D, we provide that we consider all 

other malignant tumors originating in 

bone with multimodal antineoplastic 

therapy to be disabling for 12 months 

from the date of diagnosis. Consistent 

with the changes we have made for 

other listings, any residual 

impairment(s) will be evaluated under

67024 Federal Register / Vol. 69, No. 219 / Monday, November 15, 2004 / Rules and Regulations 

the criteria for the affected body system 

after that period. With this criterion, we 

recognize the length and debilitating 

effects of multimodal treatment for these 

tumors. 

Listing 13.12—Maxilla, Orbit, or 

Temporal Fossa 

This listing corresponds to prior 

listing 13.11. As noted above, we 

evaluate tumors of the mandible under 

final listing 13.11. Final listings 13.12A 

and 13.12B reorganize the criteria in 

prior listings 13.11A and 13.11B by 

moving the criterion for carcinoma with 

regional or distant metastases (part of 

prior listing 13.11B) to final listing 

13.12A. We did this so that all tumors 

of the maxilla, orbit, or temporal fossa 

with regional or distant metastases 

would be covered in the same listing. 

The final listings do not make any 

substantive changes. 

In the NPRM, we inadvertently 

changed the word ‘‘temporal’’ in the 

heading of current listing 13.11 to 

‘‘infratemporal’’ in the heading of 

proposed listing 13.12 (66 FR at 59323). 

We are correcting the heading in these 

final rules. Additionally, although we 

moved the criterion for carcinoma with 

regional or distant metastases to 

proposed listing 13.12A, we failed to 

remove the criterion from proposed 

listing 13.12B. We are removing the 

criterion from final listing 13.12B in 

response to a public comment 

indicating that retaining the criterion in 

listing 13.12B was redundant. 

In final listing 13.12C, we consolidate 

the disease sites in prior listings 13.11C, 

13.11D, 13.11E, and 13.11F. 

Listing 13.13—Nervous System 

This listing incorporates the criteria 

for malignant brain tumors from listing 

11.05, ‘‘Brain tumors,’’ in the 

neurological body system, and replaces 

prior listing 13.12, ‘‘Brain or spinal 

cord.’’ We are expanding the listings to 

include tumors of the spinal cord, 

spinal nerve roots, and the peripheral 

nervous system. We are also including 

tumors of the central nervous system 

that are not specifically named. 

Under final listing 13.13A, we 

evaluate central nervous system 

malignant neoplasms; that is, those 

affecting the brain or spinal cord. In 

final listing 13.13A1, we list and revise 

the criteria for the impairments named 

in prior listing 11.05A. We are revising 

the reference to medulloblastoma to 

include other primitive 

neuroectodermal tumors (PNETs) and to 

require documented metastases for this 

type of tumor. Advances in treatment 

have significantly improved the overall 

prognosis of this disease, so that, in the 

absence of metastases, many individuals 

do well. We can evaluate 

medulloblastomas or other PNETs that 

have not metastasized, as well as the 

malignant brain tumors listed in prior 

listing 11.05B, under final listing 

13.13A2. 

We are also adding diffuse intrinsic 

brain stem gliomas in final listing 

13.13A1. We are requiring that the 

impairment be ‘‘diffuse’’ and ‘‘intrinsic’’

because progress in medical diagnostic 

tools has now allowed for effective 

treatment of individuals with localized 

brain stem tumors. 

In the NPRM, the criteria in proposed 

listing 13.13A were preceded by the 

phrase, ‘‘Central nervous system 

neoplasms (brain and spinal cord), 

including * * *.’’ In final listing 

13.13A, we are changing the word 

‘‘including’’ to the phrase ‘‘as described 

in 1 or 2’’ to be consistent with other 

listings.

In final listing 13.13B, we provide 

criteria for evaluating malignant tumors 

of peripheral nerves and spinal roots. 

In the NPRM, we had proposed a 

listing, listing 13.13C, to correspond to 

prior listing 13.12A for metastatic 

carcinoma to brain or spinal cord. In 

response to a public comment, we have 

determined that this listing is 

unnecessary. These malignancies will 

be evaluated under the criteria for the 

site of origin, or under listing 13.27 if 

the primary site is unknown. Therefore, 

we are removing prior listing 13.12A 

and proposed listing 13.13C. We are 

also removing prior listing 13.12B, 

which was a reference listing. 

Listing 13.14—Lungs 

This listing corresponds to prior 

listing 13.13. In final listing 13.14A, we 

consolidate prior listings 13.13A, 

13.13B, 13.13D, and 13.13E. This 

change is consistent with current 

medical terminology, which no longer 

distinguishes between the types of nonsmall-cell carcinoma. 

In the NPRM, proposed listing 13.14A 

covered metastatic disease to or beyond 

the mediastinal or subcarinal lymph 

nodes. A public comment pointed out 

that this criterion would exclude cases 

of non-small-cell carcinomas with 

metastases to the hilar lymph nodes that 

had been included under prior listing 

13.13E. The comment also indicated 

that, even when the involved hilar 

nodes are excised, the prognosis for this 

disease is unfavorable. In response to 

this comment, we have revised final 

listing 13.14A to include metastases to 

the hilar nodes. 

We are redesignating prior listing 

13.13C as final listing 13.14B. We are 

making no substantive changes. 

Listing 13.15—Pleura or Mediastinum 

This listing corresponds to prior 

listing 13.14. Final listing 13.15A is the 

same as prior listing 13.14A. In final 

listing 13.15B, which corresponds to 

prior listing 13.14C, we provide new 

language that clarifies the phrase ‘‘not 

controlled by prescribed therapy’’ used 

in the prior listing. 

In the NPRM, the criterion in 

proposed listing 13.15B1 was 

‘‘Metastatic.’’ In final listing 13.15B1, 

we revise this criterion to ‘‘With 

metastases to or beyond the regional 

lymph nodes’’ to be consistent with the 

other listings in these rules. 

We are removing prior listing 13.14B, 

‘‘Malignant tumors, metastatic to 

pleura.’’ We will evaluate this 

malignancy under final listing 13.27, 

‘‘Primary site unknown.’’

Listing 13.16—Esophagus or Stomach 

This listing corresponds to prior 

listing 13.16. Final listing 13.16A is the 

same as prior listing 13.16A. In final 

listing 13.16B, we consolidate prior 

listings 13.16B through 13.16E to clarify 

that all of those criteria relate to 

carcinoma or sarcoma of the stomach. 

We also provide new language to clarify 

the phrase ‘‘not controlled by prescribed 

therapy’’ used in prior listing 13.16C. 

Listing 13.17—Small Intestine 

This listing corresponds to prior 

listing 13.17. In final listing 13.17A, we 

expand the criterion in prior listing 

13.17B, for recurrent malignancies, to 

indicate that inoperable and 

unresectable malignancies are also of 

listing-level severity. We also provide 

new language to clarify the phrase ‘‘not 

controlled by prescribed therapy’’ used 

in prior listing 13.17C. Final listing 

13.17B corresponds to prior listing 

13.17A, and is substantively unchanged. 

Listing 13.18—Large Intestine (From 

Ileocecal Valve to and Including Anal 

Canal) 

This listing corresponds to prior 

listing 13.18. We are removing the 

phrase ‘‘carcinoma or sarcoma’’ from the 

heading of this listing because sarcomas 

of the large intestine are extremely rare. 

In final listing 13.18A, we consolidate 

prior listings 13.18A and 13.18C and 

clarify that these criteria apply to 

adenocarcinoma. In final listing 13.18B, 

we provide that squamous cell 

carcinoma of the anus will not be found 

to meet the listing unless it is recurrent 

after surgery. Advances in treatment 

have made chemotherapy and radiation 

the treatment of choice for this disorder. 

However, good results can be achieved 

through surgery if the preferred 

treatment is not effective. Final listing

Federal Register / Vol. 69, No. 219 / Monday, November 15, 2004 / Rules and Regulations 67025

13.18C is the same as prior listing 

13.18B. 

Listing 13.19—Liver or Gallbladder 

This listing corresponds to prior 

listing 13.19. We are clarifying that the 

listing applies only to malignancies that 

originate in the liver, gallbladder, or bile 

ducts. We evaluate metastases to the 

liver from other sites under the criteria 

for the site of origin, or under the 

criteria of final listing 13.27 when the 

primary site is unknown. 

Listing 13.20—Pancreas 

This listing corresponds to prior 

listing 13.20. We are not making any 

substantive changes, other than adding 

‘‘inoperable’’ conditions to the second 

listing criterion. We are making this 

change to reflect the revised definitions 

used in these listings.

Listing 13.21—Kidneys, Adrenal Glands, 

or Ureters 

This listing corresponds to prior 

listing 13.21. In final listing 13.21A, we 

expand the criteria of unresectable 

tumors in prior listing 13.21A to include 

inoperable and recurrent tumors. Final 

listing 13.21B consolidates prior listings 

13.21B and 13.21C. We are eliminating 

the modifier ‘‘hematogenous’’ used in 

prior listing 13.21B because metastases 

by lymphatic spread or by direct 

extension carry the same poor 

prognosis. 

Listing 13.22—Urinary Bladder 

This listing corresponds to prior 

listing 13.22. We are removing prior 

listing 13.22E, which provided for the 

evaluation of renal impairment 

following total cystectomy under the 

criteria in listing 6.02, because it was a 

reference listing. 

Listing 13.23—Cancers of the Female 

Genital Tract 

In this listing, we incorporate and 

revise prior listings 13.25, ‘‘Uterus,’’

13.26, ‘‘Ovaries,’’ 13.28, ‘‘Uterine 

(Fallopian) tubes,’’ and 13.30, ‘‘Vulva.’’

In final listings 13.23A, ‘‘Uterus 

(corpus),’’ and 13.23B ‘‘Uterine cervix,’’

we replace the prior criteria in listings 

13.25B, ‘‘Recurrent after total 

hysterectomy,’’ and 13.25C, ‘‘Total 

pelvic exenteration,’’ with ‘‘Persistent or 

recurrent following initial 

antineoplastic therapy.’’ With this 

revision, we recognize changes in 

treatment for these disorders. In final 

listing 13.23C, ‘‘Vulva,’’ we provide 

criteria in addition to the criteria for 

distant metastases used in the prior 

listing. 

We are making several changes in 

final listing 13.23D, ‘‘Fallopian tubes.’’

In final listing 13.23D1, ‘‘Extending to 

the serosa or beyond,’’ we replace the 

criteria in prior listings 13.28A, 

‘‘Unresectable,’’ and 13.28B, 

‘‘Metastases to regional lymph nodes.’’

Tumors extending to the serosa are 

considered to be unresectable for the 

purposes of this listing; tumors 

extending beyond the serosa equate to 

tumors that have metastasized to the 

regional lymph nodes. In final listing 

13.23D2, we are also adding criteria to 

evaluate fallopian tube tumors when the 

initial antineoplastic therapy has not 

achieved the desired effect. 

In final listing 13.23E, ‘‘Ovaries,’’ we 

separate germ-cell and non-germ-cell 

tumors. In final listing 13.23E1, which 

provides the criteria for evaluating nongerm-cell tumors, we expand the criteria 

in prior listing 13.26 to reflect advances 

in diagnostic techniques and treatment. 

We provide criteria for evaluating germcell tumors in final listing 13.23E2. 

Listing 13.24—Prostate Gland 

In this listing, which corresponds to 

prior listing 13.23, we provide new 

language to clarify the phrase ‘‘not 

controlled by prescribed therapy’’ used 

in the prior listing. 

Listing 13.25—Testicles 

This listing corresponds to prior 

listing 13.24. We are removing prior 

listing 13.24A, for choriocarcinoma 

because the literature we consulted does 

not separate choriocarcinoma from other 

forms of nonseminomatous germ-cell 

tumors with regard to staging or 

treatment. (See 67 FR 19138 for a list of 

the literature we consulted.) 

Listing 13.26—Penis 

This listing corresponds to prior 

listing 13.29. We have clarified the 

listing to explicitly include metastases 

to or beyond the regional lymph nodes. 

Listing 13.27—Primary Site Unknown 

After Appropriate Search for Primary 

We are providing a listing for the 

occasional case in which metastases 

have been appropriately verified but the 

site of the primary malignancy cannot 

be determined. The final listing 

specifically excludes solitary squamous 

cell carcinoma in the neck, as this type 

of metastasis is often amenable to 

treatment.

Listing 13.28—Malignant Neoplastic 

Diseases Treated by Bone Marrow or 

Stem Cell Transplantation 

As we have already noted in our 

discussion of final 13.00L above, final 

listing 13.28 is a listing for bone marrow 

or stem cell transplantation in any 

malignant neoplastic disease other than 

acute leukemia, CML, lymphoma, or 

multiple myeloma, which we evaluate 

under final listings 13.05, 13.06 and 

13.07. In final listing 13.28A, we 

provide that allogeneic transplantation 

is disabling until at least 12 months 

from the date of transplantation. In final 

listing 13.28B, we provide that 

autologous transplantation is disabling 

until at least 12 months from the date 

of the first treatment under the 

treatment plan that includes 

transplantation. We use an earlier date 

to begin the 12-month period for 

autologous transplantation because the 

recovery period after this type of 

transplantation is generally shorter than 

for allogeneic transplantation. In both 

cases, we will evaluate any residual 

impairment(s) after the applicable 

period under the criteria for the affected 

body system. 

How Are We Changing the Introductory 

Text to the Listings for Evaluating 

Malignant Neoplastic Diseases in 

Children? 

113.00 Malignant Neoplastic Diseases 

Except for minor changes to refer to 

children, we are repeating much of the 

introductory text in 13.00 in the 

introductory text in 113.00. This is 

because the same basic rules for 

establishing and evaluating the 

existence and severity of malignant 

neoplastic diseases in adults also apply 

to children. Because we have already 

described these provisions under the 

explanation of 13.00, the following 

discussions describe only those 

provisions that are unique to the 

childhood rules or that require further 

explanation. 

113.00B—What Do We Consider When 

We Evaluate Malignant Neoplastic 

Diseases Under These Listings? 

In this section, which is the same as 

final 13.00B, we replace the guidance in 

prior 113.00A1. 

113.00D—What Evidence Do We Need? 

In this section, we replace and expand 

prior 113.00B. This section is 

substantively the same as final 13.00D. 

We are not including a childhood listing 

to correspond to final listing 13.27, 

primary site unknown after appropriate 

search for primary, because the inability 

to determine the primary site is an 

extremely rare occurrence in childhood 

malignancies. Instead, we indicate that, 

in these rare situations, we will use final 

listing 13.27.

67026 Federal Register / Vol. 69, No. 219 / Monday, November 15, 2004 / Rules and Regulations 

113.00E—When Do We Need 

Longitudinal Evidence? 

This section is similar to final 13.00E. 

We are adding a general description of 

most malignant childhood tumors. 

113.00F—How Do We Evaluate 

Impairments That Do Not Meet One of 

the Malignant Neoplastic Diseases 

Listings? 

In this section, we repeat the guidance 

in final 13.00F, but use the definition of 

disability for children who claim SSI 

payments. 

113.00G—How Do We Consider the 

Effects of Therapy? 

This section replaces prior 113.00A2 

and the last paragraph of prior 113.00A. 

We repeat the guidance in final 13.00G 

but use the definition of disability for 

children who claim SSI payments. 

113.00H—How Long Do We Consider 

Your Impairment To Be Disabling? 

This section corresponds to final 

13.00H. It also replaces prior 113.00D, 

‘‘Duration of disability,’’ which referred 

to the specific time periods that we 

included in prior listings 113.02 and 

113.03. Although we do not cite specific 

listings, we indicate that some listings 

specify that the impairment should be 

considered disabling until a particular 

point in time. In final 113.00H2, we 

state that, when the listing does not 

contain such a specification, we will 

consider an impairment that meets or 

medically equals the listings in this 

body system to be disabling until at 

least 3 years after onset of complete 

remission. We added this section to 

ensure consistency between the adult 

and childhood rules. 

113.00I—What Do These Terms in the 

Listings Mean? 

This section corresponds to final 

13.00I. As we explain below, we are 

retaining our listings for malignant solid 

tumors. Because of this, there are no 

listings in part B of these final rules that 

include the terms ‘‘inoperable’’ and 

‘‘unresectable.’’ Therefore, in these final 

rules, we revised proposed 113.00I to 

remove the definitions of those terms. 

113.00K—How Do We Evaluate Specific 

Malignant Neoplastic Diseases? 

In this section, we incorporate the 

discussion in prior 107.00C, ‘‘Acute 

leukemia,’’ and provide guidance for 

other childhood malignancies. Except 

for minor changes to refer to children, 

final 113.00K4, ‘‘Brain Tumors,’’ is the 

same as final 13.00K6. The following is 

a discussion of the other malignant 

neoplastic diseases addressed in this 

section. 

113.00K1—Lymphoma

In this section, we indicate that final 

listing 113.05 should not be used for 

evaluating low grade or indolent 

lymphomas because they are rare in 

children. We will evaluate these 

lymphomas under final listing 13.05. 

We also indicate that many children 

with lymphoma are treated according to 

a long-term protocol that can result in 

significant adverse medical, social, and 

emotional consequences. We provide a 

reference to final 113.00G to evaluate 

those consequences. 

113.00K2—Leukemia 

In final 113.00K2c, we provide a 

description of juvenile CML (JCML) and 

explain that we will evaluate it under 

final listing 113.06A. 

Final 113.00K2d is similar to final 

13.00K2d. We did not include a 

discussion about chronic lymphocytic 

leukemia, as in final 13.00K2c, because 

the disorder is extremely rare in 

children. 

113.00K3—Malignant Solid Tumors 

In this section, we incorporate the 

guidance in prior 113.00C, ‘‘Malignant 

solid tumors.’’ We have revised the 

reference to the listing for brain tumors 

because that listing is now in this body 

system. As we have added a listing for 

the thyroid gland, we no longer need 

guidance in the introductory text 

explaining how thyroid tumors should 

be evaluated. 

113.00K5—Retinoblastoma 

In this section, we state that treatment 

for bilateral retinoblastoma usually 

results in a visual impairment and that 

we will evaluate any resulting visual 

impairment under listing 102.02. 

113.00L—How Do We Evaluate 

Malignant Neoplastic Diseases Treated 

by Bone Marrow or Stem Cell 

Transplantation? 

In this section, we provide the same 

guidance as in final 13.00L1, 13.00L2, 

and 13.00L4. We have added JCML to 

the heading of 13.00L1 to reflect that 

JCML is included in final listing 

113.06A. We do not refer to multiple 

myeloma in final 113.00L2 because this 

impairment is not included in the final 

childhood listings. Multiple myeloma is 

extremely rare in children. 

In the NPRM, we had also proposed 

a section in part B, similar to final 

13.00L3, that contained guidance on 

how to evaluate bone marrow or stem 

cell transplantation for other disorders 

in children. That section, proposed 

113.00L3, indicated that malignant 

neoplastic diseases treated with bone 

marrow or stem cell transplantation 

should be evaluated under proposed 

listing 113.28. Proposed listing 113.28 

was one of several listings that we 

proposed as a replacement for prior 

listing 113.03, ‘‘Malignant solid 

tumors.’’ As we explain in the public 

comments section of this preamble, we 

have decided not to change our prior 

criteria for malignant solid tumors in 

these final rules. Therefore, we do not 

need the guidance we included in 

proposed section 113.00L3, and we are 

not including it in these final rules. As 

we indicate in response to a public 

comment on bone marrow or stem cell 

transplantation in chidren, final listing 

13.28 can be used in those few cases in 

which the end of the 2-year period 

provided by final listing 113.03 is 

earlier than the end of the period that 

the impairment would be considered 

disabling based on the bone marrow or 

stem cell transplantation. 

How Are We Changing the Listings for 

Evaluating Malignant Neoplastic 

Diseases in Children? 

113.01 Category of Impairments, 

Malignant Neoplastic Diseases 

We are redesignating the childhood 

listings to maintain consistency with the 

adult rules for those malignancies that 

are addressed in both the adult and 

childhood rules. Because of this, the 

numbers of the final childhood listings 

are not consecutive. 

Listing 113.03—Malignant Solid Tumors 

This listing corresponds to prior 

listing 113.03, ‘‘Malignant Solid 

Tumors.’’ We are making minor 

editorial changes to make the language 

consistent with that used in other 

listings and to indicate that, after the 

appropriate time period has passed, any 

residual impairment should be 

evaluated under criteria for the affected 

body system. 

In the NPRM, we proposed removing 

prior listing 113.03 and providing 

separate listings for specific types of 

malignant solid tumors and a listing for 

malignant neoplastic diseases treated by 

bone marrow or stem cell 

transplantation. In response to a 

comment, we have decided to retain 

prior listing 113.03 as we further 

consider how to include solid tumors in 

children in our listings. Because we are 

retaining prior listing 113.03 in these 

final rules, we are not incorporating the 

proposed listings that would have 

replaced it: Proposed listing 113.04, 

‘‘Soft Tissue Sarcoma (including 

Ewing’s Sarcoma, Primitive 

Neuroectodermal Tumors (PNETs)’’; 

proposed listing 113.11, ‘‘Osteogenic 

Sarcoma’’; proposed listing 113.13A2,

Federal Register / Vol. 69, No. 219 / Monday, November 15, 2004 / Rules and Regulations 67027

for any central nervous system 

neoplasm progressive or recurrent 

following initial antineoplastic therapy; 

proposed listing 113.13B, for peripheral 

nerve or spinal root neoplasm; proposed 

listing 113.21B, for Wilms’ tumor 

persistent or recurrent following initial 

Antineoplastic therapy; proposed listing 

113.25, ‘‘Testicles—Tumor With 

Metastatic Disease Progressive of 

Recurrent Following Initial 

Chemotherapy’’; proposed listing 

113.26, ‘‘Germ Cell Tumors—Gonadal or 

Extragonadal’’; and proposed listing 

113.28, ‘‘Malignant Neoplastic Diseases 

Treated by Bone Marrow or Stem Cell 

Transplantation.’’

Listing 113.05—Lymphoma (Excluding 

T-cell Lymphoblastic Lymphoma—

113.06) 

This listing corresponds to prior 

listing 113.02, ‘‘Lymphoreticular 

malignant neoplasms.’’ We are revising 

the listing to make it more consistent 

with final listing 13.05. 

Final listing 113.05A replaces the 

criteria for non-Hodgkin’s lymphoma in 

prior listing 113.02B. Currently, there 

are several treatment regimens for this 

disease, and they vary in the amount of 

time needed to complete them. Many 

are of sufficiently short duration that the 

impairment may be disabling for less 

than 12 months. Due to these advances 

in treatment, it is no longer appropriate 

to assume that the impairment will meet 

the statutory duration requirement. 

Instead, we will find the impairment 

disabling under this listing when it is 

persistent or recurrent following initial 

antineoplastic therapy. We also clarify 

that non-Hodgkins lymphoma includes 

Burkitt’s and anaplastic large cell. 

Final listing 113.05B replaces the 

criteria for Hodgkin’s disease in prior 

listing 113.02A. With the final criterion, 

we clarify what we meant by 

‘‘progressive disease not controlled by 

prescribed therapy’’ in the prior listing. 

In final listing 113.05C, we add a 

criterion for bone marrow or stem cell 

transplantation. 

Listing 113.06—Leukemia 

This listing replaces prior listing 

107.11, ‘‘Acute leukemia.’’ In final 

listing 113.06A, for ‘‘acute leukemia,’’

we also include T-cell lymphoblastic 

lymphoma and JCML. JCML is an 

aggressive leukemia that responds 

poorly to therapy and is, therefore, more 

appropriately evaluated like an acute 

leukemia. The criteria in this listing are 

the same as in final listing 13.06A, and 

are explained in the discussion of that 

listing. 

In final listing 113.06B, which is the 

same as final listing 13.06B, we added 

criteria for evaluating CML other than 

JCML. 

Listing 113.09—Thyroid Gland 

This listing is the same as final listing 

13.09 and incorporates the guidance 

contained in prior 113.00C. The listing 

criteria define when the malignancy is 

not controlled by prescribed therapy. 

Listing 113.12—Retinoblastoma 

This final listing revises prior listing 

113.05. We are removing prior listing 

113.05A, for bilateral involvement, 

because with advances in treatment this 

malignancy is often treated successfully. 

As we indicate in final 113.00K4, we 

will evaluate the resulting visual 

impairment under listing 102.02. If 

treatment is not successful, we will 

evaluate the impairment under the other 

criteria in the final listing. 

Final listing 113.12A corresponds to 

prior listing 113.05C. We are making no 

substantive changes. 

Final listing 113.12B corresponds to 

prior listing 113.05D. We are revising 

the criteria to recognize that persistence 

after treatment, as well as recurrence, 

indicates a poor prognosis. 

Final listing 113.12C corresponds to 

prior listing 113.05B. We are revising 

the description to make it clear that any 

metastatic disease is included under the 

listing. 

Listing 113.13—Brain Tumors 

This listing revises the criteria for 

malignant brain tumors in prior listing 

111.05, ‘‘Brain tumors.’’ We use the 

same criteria for evaluating brain tumors 

in children as in final listing 13.13A1. 

In the NPRM, we proposed to expand 

the criteria in this listing to address 

other tumors of the nervous system. As 

explained above, we have decided to 

retain our prior criteria for evaluating 

malignant solid tumors, and these 

additional criteria are not needed. 

Because we are not including the 

additional criteria, we have revised the 

heading of this listing to reflect the 

types of tumors evaluated under it. 

Listing 113.21—Neuroblastoma 

Final listing 113.21A corresponds to 

prior listing 113.04, ‘‘Neuroblastoma.’’

We have made minor editorial revisions 

to be consistent with other listings. 

In the NPRM, we proposed changing 

the criteria for neuroblastoma. As 

explained above, we have decided to 

retain our prior criteria for malignant 

solid tumors as we further consider how 

to include solid tumors in children in 

our listings. Similarly, we have decided 

to retain our prior criteria for 

neuroblastoma. 

We also proposed to expand the 

criteria in this listing to address Wilms’

tumors. Because we are retaining our 

prior criteria for malignant solid tumors, 

this additional criterion is not needed. 

Therefore, we have revised the heading 

of this listing to reflect the types of 

tumors evaluated under it. 

What Other Revisions Are We Making? 

Consistent with the changes 

explained above, we are also: 

• Changing the name of 7.00 and 

107.00 from Hemic and Lymphatic 

System to Hematological Disorders. We 

are making this change because we are 

moving the lymphatic impairments now 

contained in these body systems to 

13.00 and 113.00. 

• Revising the heading of listing 7.17 

to remove the reference to hematologic 

malignancies. We are making this 

change because we are moving the 

listings for hematological malignancies 

to 13.00 and 113.00. 

• Revising 11.00B to indicate that 

malignant brain tumors should be 

evaluated under the criteria in listing 

13.13. 

• Adding 111.00E to provide the 

same guidance as final 11.00B. 

• Revising prior listings 11.05 and 

111.05 by removing the criteria for 

malignant brain tumors. In the NPRM, 

proposed listing 11.05 indicated that 

benign brain tumors would be evaluated 

under 11.02, 11.03, 11.04A or B, or 

12.02. Proposed listing 111.05 indicated 

that these tumors would be evaluated 

under the criteria for the resulting 

neurological impairment. As we 

reviewed these criteria, we realized that 

these listings should be the same. We 

also realized that they should allow for 

the evaluation of all complications of 

benign brain tumors. Therefore, we have 

replaced the reference to 12.02 with 

‘‘the criteria of the affected body 

system’’ and revised final listing 111.05 

for consistency between the adult and 

childhood listings. 

• Making nonsubstantive editorial 

changes throughout these rules to reflect 

the technical changes that were 

implemented by the final regulation we 

published in the Federal Register on 

April 24, 2002, (67 FR 20018), to correct 

typographical errors and omissions, to 

make the language clearer, and to be 

consistent with other rules.

Public Comments 

In the NPRM we published in the 

Federal Register on November 27, 2001 

(66 FR 59306), we provided the public 

with a 60-day comment period that 

ended on January 28, 2002. Due to some 

significant issues raised by commenters, 

we provided an additional 60-day

67028 Federal Register / Vol. 69, No. 219 / Monday, November 15, 2004 / Rules and Regulations 

public comment period by publishing a 

notice in the Federal Register on April 

18, 2002 (67 FR 19138). The additional 

comment period ended on June 17, 

2002. 

In response to the two notices, we 

received comments from 61 

commenters, 16 of whom addressed the 

proposed criteria for malignant 

neoplastic diseases. These 16 

commenters included medical 

organizations, legal services 

organizations, State agencies that make 

disability determinations for us, and 

individuals. Many of the commenters 

raised more than one issue. We carefully 

considered all of the comments. 

A number of the comments were quite 

long and detailed, requiring us to 

condense, summarize, or paraphrase 

them. We have tried to accurately 

present all views of the commenters and 

have tried to respond to all of the 

significant issues raised by the 

commenters. We provide our reasons for 

adopting or not adopting the comments 

in our responses below. 

General Comments 

Extend the Comment Period and 

Provide the Medical and Scientific 

Justification for the Proposed Listings. 

Comment: During the initial comment 

period, several commenters asked us to 

extend the 60-day comment period due 

to the length and complexity of the 

proposed rules. Commenters also asked 

us to provide the medical and scientific 

justification for these changes. 

Response: As we reviewed the initial 

comments, we realized that significant 

issues were being raised, and we 

determined that it would be appropriate 

to reopen the comment period in order 

to get additional input on those and 

other issues. Therefore, on April 18, 

2002, we published a notice in the 

Federal Register (67 FR 19138) 

reopening the comment period and 

providing an additional 60-day period 

within which to comment. The 

additional comment period ended on 

June 17, 2002. The notice that reopened 

the comment period included references 

to the medical and scientific sources we 

consulted when developing the NPRM, 

and invited comment on those 

references as well. 

The Proposed Listings are More 

Restrictive Than the Prior Listings 

Comment: Some commenters believed 

that these criteria reflect a trend toward 

an increased level of severity in the 

listings. One commenter noted that, 

although good arguments may be made 

for these changes, the criteria in the 

childhood listings for non-Hodgkin’s 

lymphoma, chronic granulocytic 

leukemia, thyroid carcinoma, 

medulloblastoma, Wilms’ tumor, 

testicular cancer, and germ-cell tumors 

were more restrictive. 

Response: As we reviewed our 

proposed listings to respond to the 

public comments, we realized that we 

need to consider further how to address 

childhood malignant solid tumors in 

our listings. In the interim, we are 

retaining our prior criteria that provide 

that malignant solid tumors, other than 

brain tumors or thyroid tumors, are 

disabling for 2 years from the date of 

initial diagnosis or from the date of 

recurrence of active disease. We are also 

retaining our prior criteria for 

neuroblastoma. 

Impact of the Changes 

Comment: Two commenters stated 

that the proposed rules would result in 

a considerable reduction in the number 

of individuals eligible for disability 

benefits and requested that we provide 

an estimate of the impact of these 

changes. 

Response: Based on our assessment of 

these rules, we do not believe that a 

considerable number of individuals will 

be adversely affected by the changes we 

are making in these final rules. We 

believe that these final rules 

appropriately reflect advances in 

medical knowledge, treatment, and 

methods for evaluating malignant 

neoplastic diseases.

Comment: One commenter expressed 

concern that these rules would result in 

fewer claims being allowed at step 3 of 

the sequential evaluation process, and 

that a functional assessment would be 

required in more cases. 

Response: Based on our assessment of 

these rules, we do not believe that fewer 

claims will be allowed at step 3 of the 

sequential evaluation process. 

The Proposed Listings May Result in 

Delays 

Comment: Several commenters 

expressed concern that it will take 

longer to evaluate some malignancies 

because the proposed listings for these 

malignancies require that the treatment 

has not been effective. Some of these 

commenters believed that evaluation of 

these malignancies would need to be 

delayed until treatment was completed. 

One commenter thought that we would 

not evaluate cases at other steps in the 

sequential evaluation process while we 

were waiting to determine the 

effectiveness of the treatment. One 

commenter thought that deferring 

adjudication in these cases would result 

in more informed decisions and prevent 

us from denying some cases in error. 

Response: While we agree that these 

final rules may delay the adjudication of 

some cases, we do not believe the 

number of affected cases will be 

significantly more than under the prior 

rules. The prior listings for most of these 

malignancies also included a 

requirement that the impairments not be 

controlled by prescribed therapy. To 

make this determination under the prior 

rules, we also had to allow sufficient 

time to determine whether the 

impairments would be controlled. 

When we can determine whether 

treatment will be effective before the 

treatment regimen is completed, we will 

make the decision about whether the 

malignancy is of listing-level severity at 

that point. Additionally, as we state in 

final 13.00E3 and 113.00E3, we will not 

defer adjudication to determine whether 

the therapy will achieve its intended 

effect if we can make a fully favorable 

determination or decision based on the 

length and effects of therapy, or the 

residuals of the malignancy or therapy. 

Focus on the Individual’s Particular 

Situation 

Comment: One commenter stressed 

the importance of focusing on an 

individual’s particular situation, 

especially when he or she has 

significant limitations past the listed 

disability time period. The commenter 

stated that cancer patients typically 

incur short-term impairments resulting 

from toxicities associated with 

chemotherapy and other treatment, and 

from the disease itself. The commenter 

also noted that impairments from 

treatment, such as cardiotoxicity and 

infertility, can manifest several years 

later, and that a tumor may cause 

disability to a patient for a period of 

time far surpassing that which has been 

allocated by the proposed regulations 

for certain malignant neoplastic 

diseases. The commenter believed that 

it is essential that the new regulations 

maintain sufficient flexibility to 

adequately adjust disability time 

periods based on the individualized 

nature of cancer and patient responses 

to treatment of the disease. 

Another commenter believed that the 

proposed rules did not adequately 

address problems with fatigue, energy 

levels and ability to sustain work for 

normal periods of time. The commenter 

also requested that we consider the lack 

of immunity to infection from which 

many individuals with cancer suffer. 

Response: We believe these final 

regulations do allow sufficient 

flexibility to adjust the period of time 

the individual is considered disabled 

and stress the importance of considering 

residual impairment(s) or symptoms

Federal Register / Vol. 69, No. 219 / Monday, November 15, 2004 / Rules and Regulations 67029

caused by the disease or the treatment. 

However, the severity of any residual 

impairment(s) or symptom can vary 

greatly, and must be evaluated on an 

individualized, case-by-case basis. If a 

severe residual impairment(s) does not 

meet or medically equal any listing, we 

will evaluate the impact of the 

impairment(s), as well as the impact of 

any symptoms caused by the disease or 

the treatment, at later steps in the 

sequential evaluation process. 

The Listings Need Timely Review 

Comment: Two commenters stated 

that these listings will need timely 

review in the future to keep up with 

advances in treatment and to ensure that 

they reflect current medical knowledge. 

Response: We agree that the listings 

should continue to reflect the latest 

medical knowledge and advances in 

treatment. We intend to monitor these 

listings and to update the criteria for 

any impairment contained in these 

listings as the need arises. For this 

reason, we are indicating that these 

rules will be in effect for 5 years after 

they become effective, unless we extend 

them or revise and issue them again. 

Comments on the Introductory Text 

Provide Additional Definitions 

Comment: Two commenters asked us 

to include definitions of ‘‘regional 

lymph nodes’’ and ‘‘distant metastases’’

in the introductory text. 

Response: As we indicated in our 

explanation of 13.00I, our intent is to 

use these terms as they are used in 

current clinical practice. In clinical 

practice, these terms are defined in 

relation to the site of the primary 

malignancy. To define these terms in 

our listings, we would need a separate 

definition for each primary site 

specified in the listings. Our 

adjudicative experience has shown that 

the medical evidence usually indicates 

whether the malignancy has spread to 

the regional lymph nodes or beyond. 

Therefore, we do not believe it is 

practicable or necessary to add these 

definitions to the introductory text. 

Instead, we will rely on the description 

of the malignancy contained in the 

medical records.

Documenting Complete Remission 

Comment: One commenter requested 

that we add a discussion of the 

documentation required to establish a 

‘‘complete remission.’’

Response: We partially adopted this 

comment by revising final 13.00H2 and 

113.00H2 to clarify that ‘‘complete 

remission’’ occurs when the original 

tumor and any metastases are no longer 

evident. However, we did not add a 

discussion about the documentation we 

require to establish a complete 

remission. The treating source will 

determine the methods of evaluating 

complete remission for the particular 

malignancy for each individual patient. 

We will usually rely on the 

documentation provided by the treating 

source. 

13.00 K2c—Chronic Lymphocytic 

Leukemia 

Comment: One commenter noted that 

chronic lymphocytic leukemia (CLL) is 

mentioned only in the introductory text 

and believed that this is a potential 

source of confusion. The commenter 

requested that CLL be added to the 

heading of proposed listing 13.05, 

Lymphoma, and included in the criteria 

in proposed listings 13.05A1 and 

13.05A2, which address non-Hodgkin’s 

lymphoma. 

Response: We partially adopted the 

comment. The complications of CLL are 

diverse and, because of this, it is not 

always appropriate to evaluate CLL 

using the criteria for lymphoma. By 

maintaining the references in the 

introductory text, we provide the 

flexibility needed to evaluate this 

disorder. We have, however, included a 

reference to 13.00K2c in the heading of 

final listing 13.05 as a reminder that 

CLL may be evaluated under this listing 

when appropriate. 

Evaluation of Hodgkin’s Disease That 

Recurs More Than 1 Year After 

Completion of Therapy 

Comment: One commenter disagreed 

with our proposed rule in 13.00K1c to 

consider Hodgkin’s disease that recurs 

more than 12 months after the 

completion of initial antineoplastic 

therapy as new disease under the 

listings, rather than a recurrence. The 

commenter indicated that oncologists 

would consider such patients as having 

relapsed, rather than as having 

developed a new disease. 

Response: We agree that, for treatment 

purposes, Hodgkin’s disease that recurs 

more than 12 months after the 

completion of therapy should not be 

considered as new disease. However, 

Hodgkin’s disease frequently remits 

within 12 months of the initiation of 

treatment, and the period of remission 

is often longer than 12 months. In these 

instances, the impairment would not 

satisfy the statutory duration 

requirement. If the disease then recurs, 

we have to consider it as a new disease 

for purposes of determining whether the 

duration requirement will be met. 

Additionally, secondary treatment for a 

recurrence after 12 months can result in 

complete remission or cure. 

Comments on the Listing Criteria 

Add Additional Criteria 

Comment: Several commenters 

suggested that we add specific 

additional malignancies to the listings. 

One commenter expressed concern that 

malignancies that are not contained in 

the listings because they are rare or 

because they are often amenable to 

treatment will not be properly 

evaluated. The commenter indicated 

that there are no instructions as to how 

to adjudicate the cases of individuals 

who do not respond well to treatment, 

and believed that there was no guidance 

for evaluating any cases on a case-bycase basis. The commenter also believed 

it is not acceptable to rely on the 

sequential evaluation process, since that 

process is often difficult to enforce and 

apply uniformly to people of all age 

groups. The commenter said this is 

especially true for children. The 

commenter suggested that these 

regulations include a full listing of any 

malignancy that is of listing-level 

severity. 

Response: We have not added the 

specific malignancies suggested by the 

commenters. In some instances, we 

believe the malignancies are already 

included in the final rules. For example, 

one commenter suggested we add 

nasopharyngeal cancer. This 

malignancy will be evaluated under 

final listing 13.02, for soft tissue tumors 

of the head and neck. Another 

commenter suggested we add an adult 

listing for germ-cell tumors. These 

malignancies will be evaluated under 

the criteria in listing 13.15B or listing 

13.23E2, depending on the site of the 

malignancy. 

In other instances, such as prostate 

cancer with bone metastases or earlier 

stages of multiple myeloma, we believe 

that there are effective therapies that, 

even considering their length and 

effects, generally do not result in an 

impairment of listing-level severity. In 

these situations, we believe that the 

impairment should not be considered to 

be of listing-level severity until it is 

demonstrated that therapy is not 

effective. 

We did not add the other suggested 

additions, such as granulocytic sarcoma, 

because these malignancies are rare. As 

noted in sections 13.00F and 113.00F of 

these rules, the listings contain 

examples of impairments that we 

consider severe enough to prevent an 

adult from doing any gainful activity, or 

that cause marked and severe functional 

limitations in a child. The listings are

67030 Federal Register / Vol. 69, No. 219 / Monday, November 15, 2004 / Rules and Regulations 

not intended to be all-inclusive. The 

purpose of the listings—to allow us to 

readily identify individuals with 

common impairments of listing-level 

severity—would be defeated if we tried 

to identify every malignancy that could 

be of listing-level severity. 

However, we believe that our 

regulations do provide adequate 

guidance about how to evaluate 

malignancies that do not respond to 

treatment or that are unlisted. Many of 

these final listings address situations in 

which treatment is not successful. For 

example, final listing 13.02B addresses 

the situation in which the malignancy is 

persistent following initial multimodal 

antineoplastic treatment and final 

listing 13.09B addresses the situation in 

which the malignancy is progressive 

despite radioactive iodine therapy. We 

also have other rules that discuss how 

to evaluate impairments that are not 

listed. These other rules are not 

included in this notice, as we are not 

making any changes to them. We believe 

that malignancies that are not listed can 

be properly and uniformly evaluated 

under these other rules. 

Also, and as we have already noted, 

as we reviewed our proposed listings to 

respond to the last comment, we 

realized that we need to consider further 

how to include childhood malignant 

solid tumors in our listings. In the 

interim, we have decided to retain our 

prior criteria for these impairments. 

Comment: One commenter 

recommended that all cases of 

lymphoma should be determined to be 

of listing-level severity and that cases 

not covered by the proposed rules 

should be allowed with a short 

reexamination diary. 

Response: We have not included 

criteria for additional lymphoma cases. 

It would not be appropriate to include 

lymphomas that do not satisfy the 

criteria in these final rules because we 

cannot presume that these impairments 

will meet the statutory duration 

requirement. Other lymphomas may 

respond more readily to therapy.

Use Staging Systems 

Comment: Two commenters suggested 

we incorporate accepted classifications 

and staging in the listings. One 

indicated we should use clinical 

classifications and stagings that are tied 

to ongoing tumor registries that are 

matched with survival rates. 

Response: As in the NPRM, these final 

rules incorporate staging criteria where 

appropriate. In these instances, we list 

the criteria for the stage rather than refer 

to the stage number. For example, the 

criteria in final listing 13.10A, for 

locally advanced breast carcinoma, 

correspond to stage IIIB. 

We decided not to include staging 

numbers for two reasons. The first is 

that there are different staging 

classifications and these different 

classifications are not necessarily 

consistent. The second is that staging 

classifications change. If we used the 

staging number as the criterion, these 

rules may no longer be appropriate if a 

change in staging classifications is 

made. 

Listings With Time Limits 

Comment: Several commenters noted 

that several of the proposed listings 

included language about time limits 

after which the adjudicator was advised 

to evaluate any residual impairment(s) 

under the relevant body system, but that 

these listings did not refer to the 

medical improvement review standard 

in §§ 404.1594, 416.994, and 416.994a. 

They believed that failure to apply the 

medical improvement review standard 

at the end of the specified period would 

be contrary to the statute. One of these 

commenters believed that a time limit 

should, at most, result in a date for 

reviewing the individual’s continuing 

eligibility for disability benefits. 

Response: As in the prior listings and 

in a number of listings in other body 

systems, some of the listings in these 

final rules contain time limits in their 

criteria to explain the period for which 

we will presume that the individuals are 

disabled based on the nature of their 

impairments, the duration and effects of 

therapy, and the expected course of the 

impairments. After the therapy is 

completed and the relevant time period 

has passed, we can no longer presume 

that these individuals are disabled. 

When we review these claims to 

determine if these individuals continue 

to be disabled, we will apply the 

appropriate medical improvement 

review standard set forth in our 

regulations in §§ 404.1594, 416.994, or 

416.994a. 

Final Listing 13.02 

Comment: One commenter noted that 

we replaced the phrase ‘‘not controlled 

by prescribed therapy’’ in prior listing 

13.02B with ‘‘[p]ersistent disease 

following initial multimodal 

antineoplastic therapy’’ in proposed 

listing 13.02B. The commenter 

expressed concern that this criterion 

would exclude patients who are treated 

with radiation alone (uni-modal 

therapy), have persistent disease, and 

who cannot undergo surgery because of 

the medical condition or because the 

tumor remains unresectable. The 

commenter indicated the prognosis for 

these individuals seems to fit the intent 

of the listing. The commenter 

recommended we use the phrase 

‘‘therapy for curative intent’’ instead of 

‘‘initial multimodal antineoplastic 

therapy.’’

Response: We did not adopt the 

comment because individuals described 

in the comment have impairments that 

meet final listing 13.02A. That listing 

describes individuals who have tumors 

that are inoperable or unresectable. The 

definitions of the terms ‘‘inoperable’’

and ‘‘unresectable’’ in final 13.00I1 and 

13.00I2 include the individuals 

described by the commenter. 

Comment: One commenter noted the 

criterion for epidermoid carcinoma 

occurring in the pyriform sinus in 

proposed listing 13.02E and questioned 

why this site was singled out. The 

commenter indicated this impairment 

would be covered under the criteria for 

soft tissue tumors with multimodal 

therapy in proposed listing 13.02F. 

Response: We agree with the 

commenter and have deleted the 

criterion for epidermoid carcinoma 

occurring in the pyriform sinus in final 

listing 13.02. Due to this deletion, we 

redesignated proposed listing 13.02F, 

for soft tissue tumors of the head and 

neck treated with multimodal therapy, 

as final listing 13.02E. 

Final Listing 13.05 

Comment: One commenter believed 

that the language in proposed listing 

13.05A2, for low-grade or indolent 

lymphoma requiring initiation of more 

than 1 antineoplastic treatment regimen 

within a consecutive 12-month period, 

was confusing. The commenter 

indicated that we should specify that 

concurrent treatments would not apply 

and that the treatments must occur on 

separate occasions. 

Response: The listing refers to a 

treatment regimen that may consist of 

more than one modality of treatment. 

The modalities used in the treatment 

regimen may be administered 

concurrently or sequentially, depending 

on the regimen. Regardless of the way 

the modalities are administered, they 

are still considered to be one treatment 

regimen. Therefore, we have not 

adopted the commenter’s suggested 

changes. 

However, in reviewing the proposed 

listing in response to this comment, we 

realized that some clarification of the 

introductory text to the listings was 

needed. The heading of final listing 

13.05 cross-refers to 13.00K1 in the 

introductory text. However, proposed 

13.00K1a discussed only ‘‘indolent’’

lymphoma, and did not refer to ‘‘low 

grade’’ lymphoma even though the

Federal Register / Vol. 69, No. 219 / Monday, November 15, 2004 / Rules and Regulations 67031

listing refers to both. This was an 

oversight. To be consistent with the 

listing criteria, we have amended final 

13.00K1a to refer to both low grade and 

indolent lymphomas.

Final Listing 13.10 

Comment: One commenter noted the 

criterion for breast cancer in proposed 

listing 13.10C, for recurrent carcinoma, 

except local recurrence that remits with 

antineoplastic therapy. The commenter 

believed that this criterion should be 

interpreted to mean a recurrence that 

remits with therapy subsequent to 

initial treatment and that adjudicators 

would therefore be looking at two 

separate events. The commenter asked 

whether this interpretation was correct. 

Response: The commenter’s 

interpretation is correct. Breast 

carcinoma that had previously remitted 

with initial antineoplastic treatment, 

that has now recurred locally, and that 

remits with the antineoplastic therapy 

given for the recurrence does not 

represent an impairment of listing-level 

severity. An example is breast cancer 

that initially remits following a 

lumpectomy and radiation, but later 

recurs at the site of the incision, and is 

successfully treated with mastectomy. 

Final Listing 13.12 

Comment: One commenter noted that 

the phrase ‘‘or with regional or distant 

metastases’’ in proposed listing 13.12B 

was unnecessary as regional and distant 

metastases are covered in proposed 

listing 13.12A. 

Response: We agree with the 

commenter and have removed the 

phrase from final listing 13.12B. 

Final Listing 13.13 

Comment: One commenter questioned 

why we retained the listing for 

metastatic carcinoma to the brain 

(proposed listings 13.13C and 113.13C) 

when all other listings refer to the site 

of origin of the tumor. The commenter 

asked if these listings apply to cases of 

testicular cancer with brain metastases. 

Response: In response to this 

comment, we did not incorporate 

proposed listings 13.13C and 113.13C, 

for metastatic carcinoma to brain or 

spinal cord, in the final rules so that the 

final listings will refer to the site of 

origin of the tumor. We also revised the 

introductory text (13.00C and 113.00C) 

to reflect this change. 

Final Listing 13.14 

Comment: One commenter disagreed 

with the proposed deletion of the listing 

for non-squamous non-small-cell 

carcinoma with metastases to the hilar 

lymph nodes (prior listing 13.13E). The 

commenter indicated that there have not 

been significant treatment advances for 

this malignancy, nor has there been a 

significant improvement in prognosis. 

The commenter stated that excising the 

involved hilar nodes has not altered the 

unfavorable prognosis for this 

malignancy. 

Response: We agree with the 

commenter and have revised listing 

13.14A to include the hilar nodes. 

Final Listing 13.25 

Comment: One commenter objected to 

the deletion of prior listing 13.24A, for 

choriocarcinoma. The commenter 

indicated that choriocarcinoma is a 

particularly aggressive testicular cancer 

with frequent distant metastases and 

should not be evaluated in the same 

manner as other forms of testicular 

cancer. 

Response: The literature we consulted 

did not separate choriocarcinoma from 

other forms of testicular 

nonseminomatous germ-cell tumors 

with regard to staging or treatment. 

Therefore, we did not adopt the 

comment. 

Final Listing 113.10 

Comment: One commenter questioned 

the proposed deletion of the criterion 

for bilateral retinoblastoma (prior listing 

113.05A). The commenter indicated that 

most children with this disease are 

blind in one eye and have decreased 

vision in the other eye, resulting in 

significant visual impairments.

Response: We recognize that the 

current treatment of this disease results 

in significant visual impairments. While 

we have not retained this criterion in 

final listing 113.10, we have added 

guidance to the introductory text, final 

113.00K5, providing that we will 

evaluate any resulting visual 

impairment(s) under the criteria in 

listing 102.02. 

Final Listing 113.21 

Comment: One commenter noted that 

prior listing 113.04, for neuroblastoma, 

included a criterion for recurrent 

disease which was not included in 

proposed listing 113.21A. The 

commenter asked if we intended to 

delete this criterion, as the deletion was 

not addressed in the explanation of the 

proposed listing. 

Response: We did not intend to delete 

this criterion, and it is included in these 

rules as final listing 113.21C. 

Final Listings 113.25 and 113.26 

Comment: Two commenters noted 

that testicular germ-cell tumors could be 

evaluated under either proposed listing 

113.25, for testicular malignancies, or 

proposed listing 113.26, for germ-cell 

tumors. The commenters suggested that 

we evaluate testicular germ-cell tumors 

under the listing for testicular 

malignancies and exclude them from 

the listing for germ-cell tumors. 

Response: We did not adopt the 

comments because we decided to retain 

our prior criteria for malignant solid 

tumors in children. Under these final 

rules, malignant neoplasms that would 

have been evaluated under the proposed 

listings 113.25 and 113.26 will be 

considered to be disabling for 2 years 

from the date of initial diagnosis or the 

date of recurrence of active disease. 

Final Listing 113.28 

Comment: One commenter believed 

that a 12-month listing criterion is too 

short for children who have malignant 

neoplastic diseases treated by allogeneic 

bone marrow or stem cell 

transplantation. The commenter 

believed we should consider the 

increased risk of acute or chronic graft 

vs. host disease and infection in 

pediatric patients. 

Response: As already noted, we 

decided to retain our prior criteria for 

malignant solid tumors in children. 

Therefore, we are not including the 

proposed listing that was the subject of 

this comment in these final rules. 

Under these final rules, criteria for 

evaluating bone marrow or stem cell 

transplants in cases of leukemia or 

lymphoma are included in the listings 

for those disorders, final listings 113.05 

and 113.06. Under final listing 113.03, 

malignant solid tumors in children will 

be considered disabling for 2 years from 

the date of initial diagnosis or the date 

of recurrence of active disease 

regardless of whether a bone marrow or 

stem cell transplant has been performed. 

The adult listing for bone marrow or 

stem cell transplantation, final listing 

13.28, can be used to evaluate those few 

cases in which the end of the 2-year 

period is earlier than the end of the 

period that the impairment would be 

considered disabling based on the bone 

marrow or stem cell transplantation. 

Final listing 13.28A, for malignant 

neoplastic diseases treated by allogeneic 

bone marrow or stem cell 

transplantation, provides that the 

individual will be considered to be 

under a disability until ‘‘at least’’ 12 

months from the date of transplantation. 

Use of the phrase ‘‘at least’’ provides us 

with the flexibility to set a longer time 

frame when appropriate.

67032 Federal Register / Vol. 69, No. 219 / Monday, November 15, 2004 / Rules and Regulations 

Regulatory Procedures 

Executive Order 12866 

We have consulted with the Office of 

Management and Budget (OMB) and 

determined that these final rules meet 

the criteria for a significant regulatory 

action under Executive Order 12866, as 

amended by Executive Order 13258. 

Thus, they were subject to OMB review.

Regulatory Flexibility Act 

We certify that these final rules do not 

have a significant economic impact on 

a substantial number of small entities 

because they affect only individuals. 

Thus, a regulatory flexibility analysis as 

provided in the Regulatory Flexibility 

Act, as amended, is not required. 

Paperwork Reduction Act 

These final rules contain reporting 

requirements at 13.00B, 13.00D, 13.00E, 

13.00G, 13.00K, 113.00B, 113.00D, 

113.00E, 113.00G, and 113.00K of the 

final rules. An Information Collection 

Request has been submitted to OMB. 

While these rules will be effective 30 

days from publication, these burdens 

will not be effective until approved by 

OMB. We will publish a notice in the 

Federal Register upon OMB’s approval 

of the information collection 

requirements.

List of Subjects in 20 CFR Part 404 

Administrative practice and 

procedure, Death benefits, Blind, 

Disability benefits, Old-Age, Survivors, 

and Disability Insurance, Reporting and 

recordkeeping requirements, Social 

Security.

(Catalog of Federal Domestic Assistance 

Program Nos. 96.001, Social SecurityDisability Insurance; 96.002, Social SecurityRetirement Insurance; 96.004, Social 

Security-Survivors insurance; and 96.006, 

Supplemental Security Income)

Dated: July 19, 2004. 

Jo Anne B. Barnhart, 

Commissioner of Social Security.

■ For the reasons set forth in the 

preamble, subpart P of part 404 of 

chapter III of title 20 of the Code of 

Federal Regulations is amended as set 

forth below:

PART 404—FEDERAL OLD-AGE, 

SURVIVORS AND DISABILITY 

INSURANCE (1950– )

■ 1. The authority citation for subpart P 

of part 404 continues to read as follows:

Authority: Secs. 202, 205(a), (b), and (d)–

(h), 216(i), 221(a) and (i), 222(c), 223, 225, 

and 702(a)(5) of the Social Security Act (42 

U.S.C. 402, 405(a), (b), and (d)–(h), 416(i), 

421(a) and (i), 422(c), 423, 425, and 

902(a)(5)); sec. 211(b), Pub. L. 104–193, 110 

Stat. 2105, 2189.

Appendix 1 to Subpart P of Part 404—

[Amended]

■ 2. Appendix 1 to subpart P of part 404 

is amended as follows:

■ a. Item 8 of the introductory text before 

part A of appendix 1 is amended by 

revising the body system name.

■ b. Item 14 of the introductory text 

before part A of appendix 1 is amended 

by revising the body system name and 

expiration date.

■ c. The Table of Contents for part A of 

appendix 1 is amended by revising the 

body system names for sections 7.00 and 

13.00.

■ d. The body system name of section 

7.00 of part A of appendix 1 is revised 

and paragraph E of the introductory text 

of section 7.00, Hematological Disorders, 

is removed.

■ e. Listings 7.11, 7.12, 7.13, 7.14, and 

7.16 of part A of appendix 1 are removed.

■ f. Listing 7.17 of part A of appendix 1 

is revised.

■ g. Paragraph B of the introductory text 

of section 11.00, Neurological, of part A 

of appendix 1 is revised.

■ h. Listing 11.05 of part A of appendix 

1 is revised.

■ i. Section 13.00 of part A of appendix 

1 is revised.

■ j. The Table of Contents for part B of 

appendix 1 is amended by revising the 

body system names for sections 107.00 

and 113.00.

■ k. The body system name of section 

107.00 of part B of appendix 1 is revised 

and paragraph C of the introductory text 

of section 107.00, Hematological 

Disorders, is removed.

■ l. Listing 107.11 of part B of appendix 

1 is removed.

■ m. Paragraph E is added to the 

introductory text of section 111.00, 

Neurological, of part B of appendix 1.

■ n. Listing 111.05 of part B of appendix 

1 is revised.

■ o. Section 113.00 of part B of appendix 

1 is revised. 

The revised text is set forth as follows:

Appendix 1 to Subpart P of Part 404—

Listing of Impairments

* * * * *

8. Hematological Disorders (7.00 and 

107.00): July 1, 2005.

* * * * *

14. Malignant Neoplastic Diseases (13.00 

and 113.00): December 15, 2009.

* * * * *

Part A

* * * * *

7.00 Hematological Disorders

* * * * *

13.00 Malignant Neoplastic Diseases

* * * * *

7.00 HEMATOLOGICAL DISORDERS

* * * * *

E. [removed]

* * * * *

7.11 [removed] 

7.12 [removed] 

7.13 [removed] 

7.14 [removed]

* * * * *

7.16 [removed] 

7.17 Aplastic anemias with bone marrow 

or stem cell transplantation. Consider under 

a disability for 12 months following 

transplantation; thereafter, evaluate 

according to the primary characteristics of 

the residual impairment.

* * * * *

11.00 NEUROLOGICAL

* * * * *

B. Brain tumors. We evaluate malignant 

brain tumors under the criteria in 13.13. For 

benign brain tumors, we determine the 

severity and duration of the impairment on 

the basis of symptoms, signs, and laboratory 

findings (11.05).

* * * * *

11.05 Benign brain tumors. Evaluate 

under 11.02, 11.03, 11.04, or the criteria of 

the affected body system.

* * * * *

13.00 MALIGNANT NEOPLASTIC 

DISEASES 

A. What impairments do these listings 

cover? We use these listings to evaluate all 

malignant neoplasms except certain 

neoplasms associated with human 

immunodeficiency virus (HIV) infection. We 

use the criteria in 14.08E to evaluate 

carcinoma of the cervix, Kaposi’s sarcoma, 

lymphoma, and squamous cell carcinoma of 

the anus if you also have HIV infection. 

B. What do we consider when we evaluate 

malignant neoplastic diseases under these 

listings? We consider factors such as the: 

1. Origin of the malignancy. 

2. Extent of involvement. 

3. Duration, frequency, and response to 

antineoplastic therapy. Antineoplastic 

therapy means surgery, irradiation, 

chemotherapy, hormones, immunotherapy, 

or bone marrow or stem cell transplantation. 

When we refer to surgery as an antineoplastic 

treatment, we mean surgical excision for 

treatment, not for diagnostic purposes. 

4. Effects of any post-therapeutic residuals. 

C. How do we apply these listings? We 

apply the criteria in a specific listing to a 

malignancy originating from that specific 

site. 

D. What evidence do we need?

1. We need medical evidence that specifies 

the type, extent, and site of the primary, 

recurrent, or metastatic lesion. When the 

primary site cannot be identified, we will use 

evidence documenting the site(s) of 

metastasis to evaluate the impairment under 

13.27. 

2. For operative procedures, including a 

biopsy or a needle aspiration, we generally 

need a copy of both the: 

a. Operative note. 

b. Pathology report. 

3. When we cannot get these documents, 

we will accept the summary of

Federal Register / Vol. 69, No. 219 / Monday, November 15, 2004 / Rules and Regulations 67033

hospitalization(s) or other medical reports. 

This evidence should include details of the 

findings at surgery and, whenever 

appropriate, the pathological findings. 

4. In some situations we may also need 

evidence about recurrence, persistence, or 

progression of the malignancy, the response 

to therapy, and any significant residuals. (See

13.00G.) 

E. When do we need longitudinal evidence?

1. Tumors with distant metastases. We 

generally do not need longitudinal evidence 

for tumors that have metastasized beyond the 

regional lymph nodes because these tumors 

usually meet the requirements of a listing. 

Exceptions are for tumors with distant 

metastases that are expected to respond to 

antineoplastic therapy. For these exceptions, 

we usually need a longitudinal record of 3 

months after therapy starts to determine 

whether the intended effect of therapy has 

been achieved and is likely to persist. 

2. Other malignancies. When there are no 

distant metastases, many of the listings 

require that we consider your response to 

initial antineoplastic therapy; that is, the 

initial planned treatment regimen. This 

therapy may consist of a single modality or 

a combination of modalities (multimodal) 

given in close proximity as a unified whole, 

and is usually planned before any 

treatment(s) is initiated. Examples of 

multimodal therapy include: 

a. Surgery followed by chemotherapy or 

radiation.

b. Chemotherapy followed by surgery. 

c. Chemotherapy and concurrent radiation. 

3. Types of treatment. Whenever the initial 

planned therapy is a single modality, enough 

time must pass to allow a determination 

about whether the therapy will achieve its 

intended effect. If the treatment fails, the 

failure will often happen within 6 months 

after the treatment starts, and there will often 

be a change in the treatment regimen. 

Whenever the initial planned therapy is 

multimodal, a determination about the 

effectiveness of the therapy usually cannot be 

made until the effects of all the planned 

modalities can be determined. In some cases, 

we may need to defer adjudication until the 

effectiveness of therapy can be assessed. 

However, we do not need to defer 

adjudication to determine whether the 

therapy will achieve its intended effect if we 

can make a fully favorable determination or 

decision based on the length and effects of 

therapy, or the residuals of the malignancy or 

therapy (see 13.00G). 

F. How do we evaluate impairments that 

do not meet one of the malignant neoplastic 

diseases listings?

1. These listings are only examples of 

malignant neoplastic diseases that we 

consider severe enough to prevent you from 

doing any gainful activity. If your severe 

impairment(s) does not meet the criteria of 

any of these listings, we must also consider 

whether you have an impairment(s) that 

meets the criteria of a listing in another body 

system. 

2. If you have a severe medically 

determinable impairment(s) that does not 

meet a listing, we will determine whether 

your impairment(s) medically equals a 

listing. (See §§ 404.1526 and 416.926.) If your 

impairment(s) does not meet or medically 

equal a listing, you may or may not have the 

residual functional capacity to engage in 

substantial gainful activity. In that situation, 

we proceed to the fourth, and, if necessary, 

the fifth steps of the sequential evaluation 

process in §§ 404.1520 and 416.920. If you 

are an adult, we use the rules in §§ 404.1594 

and 416.994, as appropriate, when we decide 

whether you continue to be disabled. 

G. How do we consider the effects of 

therapy?

1. How we consider the effects of therapy 

under the listings. In many cases, 

malignancies meet listing criteria only if the 

therapy does not achieve the intended effect: 

the malignancy persists, progresses, or recurs 

despite treatment. However, as explained in 

the following paragraphs, we will not delay 

adjudication if we can make a fully favorable 

determination or decision based on the 

evidence in the case record. 

2. Effects can vary widely.

a. Because the therapy and its toxicity may 

vary widely, we consider each case on an 

individual basis. We will request a specific 

description of the therapy, including these 

items: 

i. Drugs given. 

ii. Dosage. 

iii. Frequency of drug administration. 

iv. Plans for continued drug 

administration. 

v. Extent of surgery. 

vi. Schedule and fields of radiation 

therapy. 

b. We will also request a description of the 

complications or adverse effects of therapy, 

such as the following: 

i. Continuing gastrointestinal symptoms. 

ii. Persistent weakness.

iii. Neurological complications. 

iv. Cardiovascular complications. 

v. Reactive mental disorders. 

3. Effects of therapy may change. Because 

the severity of the adverse effects of 

antineoplastic therapy may change during 

treatment, enough time must pass to allow us 

to evaluate the therapy’s effect. The residual 

effects of treatment are temporary in most 

instances. But on occasion, the effects may be 

disabling for a consecutive period of at least 

12 months. 

4. When the initial antineoplastic therapy 

is effective. We evaluate any post-therapeutic 

residual impairment(s) not included in these 

listings under the criteria for the affected 

body system. We must consider any 

complications of therapy. When the residual 

impairment(s) does not meet or medically 

equal a listing, we must consider its effect on 

your ability to do substantial gainful activity. 

H. How long do we consider your 

impairment to be disabling?

1. In some listings, we specify that we will 

consider your impairment to be disabling 

until a particular point in time (for example, 

at least 18 months from the date of 

diagnosis). We may consider your 

impairment to be disabling beyond this point 

when the medical and other evidence 

justifies it. 

2. When a listing does not contain such a 

specification, we will consider an 

impairment(s) that meets or medically equals 

a listing in this body system to be disabling 

until at least 3 years after onset of complete 

remission. When the impairment(s) has been 

in complete remission for at least 3 years, 

that is, the original tumor and any metastases 

have not been evident for at least 3 years, the 

impairment(s) will no longer meet or 

medically equal the criteria of a listing in this 

body system. 

3. Following the appropriate period, we 

will consider any residuals, including 

residuals of the malignancy or therapy (see 

13.00G), in determining whether you are 

disabled. 

I. What do these terms in the listings 

mean?

1. Inoperable: Surgery is thought to be of 

no therapeutic value or the surgery cannot be 

performed. Examples of when surgery cannot 

be performed include a tumor that is too 

large or that invades crucial structures, or an 

intolerance of anesthesia or surgery due to 

other medical conditions. This term does not 

include situations in which the tumor could 

have been surgically removed but another 

method of treatment was chosen; for 

example, an attempt at organ preservation. 

The determination whether a tumor is 

inoperable usually occurs before attempts to 

shrink the tumor with chemotherapy or 

radiation. 

2. Unresectable: The operation was 

performed, but the malignant tumor was not 

removed. This term includes situations in 

which a tumor is incompletely resected or 

the surgical margins are positive. 

3. Persistent: Failure to achieve a complete 

remission. 

4. Progressive: The malignancy became 

more extensive after treatment. 

5. Recurrent, relapse: A malignancy that 

had been in complete remission or entirely 

removed by surgery has returned. 

J. Can we establish the existence of a 

disabling impairment prior to the date of the 

evidence that shows the malignancy satisfies 

the criteria of a listing? Yes. We will consider 

factors such as: 

1. The type of malignancy and its location. 

2. The extent of involvement when the 

malignancy was first demonstrated. 

3. Your symptoms. 

K. How do we evaluate specific malignant 

neoplastic diseases?

1. Lymphoma.

a. Many low grade or indolent (nonaggressive) lymphomas are controlled by 

well-tolerated treatment modalities, although 

they may produce intermittent symptoms 

and signs. Therefore, we may defer 

adjudication of these cases for an appropriate 

period after initiation of therapy to determine 

whether the therapy will achieve its intended 

effect. (See 13.00E3.) For a low grade or 

indolent lymphoma, the intended effect of 

therapy is usually stability of the disease 

process. When stability has been achieved, 

we will assess severity on the basis of the 

extent of involvement of other organ systems 

and residuals from therapy. 

b. A change in therapy for low grade or 

indolent lymphomas is usually an indicator 

that the therapy is not achieving its intended 

effect. However, it does not indicate this if 

the change is based on your (or your 

physician’s) choice rather than a failure to 

achieve stability. If the therapy is changed

67034 Federal Register / Vol. 69, No. 219 / Monday, November 15, 2004 / Rules and Regulations 

due solely to choice, the requirements of 

listing 13.05A2a are not met.

c. We consider Hodgkin’s disease that 

recurs more than 12 months after completing 

initial antineoplastic therapy to be a new 

disease rather than a recurrence. 

2. Leukemia.

a. Acute leukemia. The initial diagnosis of 

acute leukemia, including the accelerated or 

blast phase of chronic myelogenous 

(granulocytic) leukemia, is based upon 

definitive bone marrow examination. 

Additional diagnostic information is based 

on chromosomal analysis, cytochemical and 

surface marker studies on the abnormal cells, 

or other methods consistent with the 

prevailing state of medical knowledge and 

clinical practice. Recurrent disease must be 

documented by peripheral blood, bone 

marrow, or cerebrospinal fluid examination. 

The initial and follow-up pathology reports 

should be included. 

b. Chronic myelogenous leukemia (CML).

The diagnosis of CML should be based upon 

documented granulocytosis, including 

immature forms such as differentiated or 

undifferentiated myelocytes and myeloblasts, 

and a chromosomal analysis that 

demonstrates the Philadelphia chromosome. 

In the absence of a chromosomal analysis, or 

if the Philadelphia chromosome is not 

present, the diagnosis may be made by other 

methods consistent with the prevailing state 

of medical knowledge and clinical practice. 

c. Chronic lymphocytic leukemia.

i. The diagnosis of chronic lymphocytic 

leukemia (CLL) must be documented by 

evidence of a chronic lymphocytosis of at 

least 10,000/mm 3 for 3 months or longer, or 

other acceptable diagnostic techniques 

consistent with the prevailing state of 

medical knowledge and clinical practice. 

ii. We evaluate the complications and 

residual impairment(s) from CLL under the 

appropriate listings, such as 13.05A2, 7.02, 

and 7.15. 

d. Elevated white cell count. In cases of 

chronic leukemia (either myelogenous or 

lymphocytic), an elevated white cell count, 

in itself, is not ordinarily a factor in 

determining the severity of the impairment. 

3. Macroglobulinemia or heavy chain 

disease. The diagnosis of these diseases must 

be confirmed by protein electrophoresis or 

immunoelectrophoresis. We evaluate the 

resulting impairment(s) under the criteria of 

7.02, 7.06, 7.08, or any other affected body 

system. 

4. Bilateral primary breast cancer. We 

evaluate bilateral primary breast cancer 

(synchronous or metachronous) under 

13.10A, which covers local primary disease, 

and not as a primary disease that has 

metastasized. 

5. Carcinoma-in-situ. Carcinoma-in-situ, or 

preinvasive carcinoma, usually responds to 

treatment. When we use the term 

‘‘carcinoma’’ in these listings, it does not 

include carcinoma-in-situ. 

6. Brain tumors. We use the criteria in 

13.13 to evaluate malignant brain tumors. We 

will evaluate any complications of malignant 

brain tumors, such as resultant neurological 

or psychological impairments, under the 

criteria for the affected body system. We 

evaluate benign brain tumors under 11.05. 

L. How do we evaluate malignant 

neoplastic diseases treated by bone marrow 

or stem cell transplantation? Bone marrow or 

stem cell transplantation is performed for a 

variety of malignant neoplastic diseases. 

1. Acute leukemia (including T-cell 

lymphoblastic lymphoma) or accelerated or 

blast phase of CML. If you undergo bone 

marrow or stem cell transplantation for any 

of these disorders, we will consider you to 

be disabled until at least 24 months from the 

date of diagnosis or relapse, or at least 12 

months from the date of transplantation, 

whichever is later. 

2. Lymphoma, multiple myeloma, or 

chronic phase of CML. If you undergo bone 

marrow or stem cell transplantation for any 

of these disorders, we will consider you to 

be disabled until at least 12 months from the 

date of transplantation. 

3. Other malignancies. We will evaluate 

any other malignant neoplastic disease 

treated with bone marrow or stem cell 

transplantation under 13.28, regardless of 

whether there is another listing that 

addresses that impairment. The length of 

time we will consider you to be disabled 

depends on whether you undergo allogeneic 

or autologous transplantation. 

a. Allogeneic bone marrow or stem cell 

transplantation. If you undergo allogeneic 

transplantation (transplantation from an 

unrelated donor or a related donor other than 

an identical twin), we will consider you to 

be disabled until at least 12 months from the 

date of transplantation. 

b. Autologous bone marrow or stem cell 

transplantation. If you undergo autologous 

transplantation (transplantation of your own 

cells or cells from your identical twin 

(syngeneic transplantation)), we will 

consider you to be disabled until at least 12 

months from the date of the first treatment 

under the treatment plan that includes 

transplantation. The first treatment usually 

refers to the initial therapy given to prepare 

you for transplantation. 

4. Evaluating disability after the 

appropriate time period has elapsed. We 

consider any residual impairment(s), such as 

complications arising from:

a. Graft-versus-host (GVH) disease. 

b. Immunosuppressant therapy, such as 

frequent infections. 

c. Significant deterioration of other organ 

systems. 

13.01 Category of Impairments, Malignant 

Neoplastic Diseases 

13.02 Soft tissue tumors of the head and 

neck (except salivary glands—13.06—and 

thyroid gland—13.07).

A. Inoperable or unresectable.

OR

B. Persistent disease following initial 

multimodal antineoplastic therapy.

OR

C. Recurrent disease following initial 

antineoplastic therapy, except local vocal 

cord recurrence.

OR

D. With metastases beyond the regional 

lymph nodes.

OR

E. Soft tissue tumors of the head and neck 

not addressed in A-D, with multimodal 

antineoplastic therapy. Consider under a 

disability until at least 18 months from the 

date of diagnosis. Thereafter, evaluate any 

residual impairment(s) under the criteria for 

the affected body system. 

13.03 Skin.

A. Sarcoma or carcinoma with metastases 

to or beyond the regional lymph nodes.

OR

B. Melanoma, with either 1 or 2: 

1. Recurrent after wide excision (except an 

additional primary melanoma at a different 

site, which is not considered to be recurrent 

disease). 

2. Palpable nodal metastases or metastases 

to adjacent skin (satellite lesions) or 

elsewhere. 

13.04 Soft tissue sarcoma.

A. With regional or distant metastases.

OR

B. Persistent or recurrent following initial 

antineoplastic therapy. 

13.05 Lymphoma (including mycosis 

fungoides, but excluding T-cell 

lymphoblastic lymphoma—13.06). (See

13.00K1 and 13.00K2c.) 

A. Non-Hodgkin’s lymphoma, as described 

in 1 or 2: 

1. Intermediate or high-grade lymphoma 

persistent or recurrent following initial 

antineoplastic therapy. 

2. Low-grade or indolent lymphoma 

requiring initiation of more than one 

antineoplastic treatment regimen within a 

consecutive 12-month period. Consider 

under a disability from at least the date of 

initiation of the treatment regimen that failed 

within 12 months.

OR

B. Hodgkin’s disease with failure to 

achieve clinically complete remission, or 

recurrent disease within 12 months of 

completing initial antineoplastic therapy.

OR

C. With bone marrow or stem cell 

transplantation. Consider under a disability 

until at least 12 months from the date of 

transplantation. Thereafter, evaluate any 

residual impairment(s) under the criteria for 

the affected body system. 

13.06 Leukemia. (See 13.00K2.) 

A. Acute leukemia (including T-cell 

lymphoblastic lymphoma). Consider under a 

disability until at least 24 months from the 

date of diagnosis or relapse, or at least 12 

months from the date of bone marrow or stem 

cell transplantation, whichever is later. 

Thereafter, evaluate any residual 

impairment(s) under the criteria for the 

affected body system.

OR

B. Chronic myelogenous leukemia, as 

described in 1 or 2: 

1. Accelerated or blast phase. Consider 

under a disability until at least 24 months 

from the date of diagnosis or relapse, or at 

least 12 months from the date of bone 

marrow or stem cell transplantation, 

whichever is later. Thereafter, evaluate any 

residual impairment(s) under the criteria for 

the affected body system. 

2. Chronic phase, as described in a or b:

Federal Register / Vol. 69, No. 219 / Monday, November 15, 2004 / Rules and Regulations 67035

a. Consider under a disability until at least 

12 months from the date of bone marrow or 

stem cell transplantation. Thereafter, 

evaluate any residual impairment(s) under 

the criteria for the affected body system. 

b. Progressive disease following initial 

antineoplastic therapy. 

13.07 Multiple myeloma (confirmed by 

appropriate serum or urine protein 

electrophoresis and bone marrow findings).

A. Failure to respond or progressive 

disease following initial antineoplastic 

therapy.

OR

B. With bone marrow or stem cell 

transplantation. Consider under a disability 

until at least 12 months from the date of 

transplantation. Thereafter, evaluate any 

residual impairment(s) under the criteria for 

the affected body system. 

13.08 Salivary glands—carcinoma or 

sarcoma with metastases beyond the regional 

lymph nodes. 

13.09 Thyroid gland.

A. Anaplastic (undifferentiated) carcinoma.

OR

B. Carcinoma with metastases beyond the 

regional lymph nodes progressive despite 

radioactive iodine therapy. 

13.10 Breast (except sarcoma—13.04).

(See 13.00K4.) 

A. Locally advanced carcinoma 

(inflammatory carcinoma, tumor of any size 

with direct extension to the chest wall or 

skin, tumor of any size with metastases to the 

ipsilateral internal mammary nodes).

OR

B. Carcinoma with distant metastases.

OR

C. Recurrent carcinoma, except local 

recurrence that remits with antineoplastic 

therapy. 

13.11 Skeletal system—carcinoma or 

sarcoma. 

A. Inoperable or unresectable.

OR

B. Recurrent tumor (except local 

recurrence) after initial antineoplastic 

therapy.

OR

C. With distant metastases.

OR

D. All other tumors originating in bone 

with multimodal antineoplastic therapy. 

Consider under a disability for 12 months 

from the date of diagnosis. Thereafter, 

evaluate any residual impairment(s) under 

the criteria for the affected body system. 

13.12 Maxilla, orbit, or temporal fossa.

A. Sarcoma or carcinoma of any type with 

regional or distant metastases.

OR

B. Carcinoma of the antrum with extension 

into the orbit or ethmoid or sphenoid sinus.

OR

C. Tumors with extension to the base of the 

skull, orbit, meninges, or sinuses. 

13.13 Nervous system. (See 13.00K6.)

A. Central nervous system neoplasms 

(brain and spinal cord), as described in 1 or 

2: 

1. Highly malignant tumors, such as Grades 

III and IV astrocytomas, glioblastoma 

multiforme, ependymoblastoma, 

medulloblastoma or other primitive 

neuroectodermal tumors (PNETs) with 

documented metastases, diffuse intrinsic 

brain stem gliomas, or primary sarcomas. 

2. Any central nervous system neoplasm 

progressive or recurrent following initial 

antineoplastic therapy.

OR

B. Peripheral nerve or spinal root 

neoplasm, as described in 1 or 2: 

1. Metastatic. 

2. Progressive or recurrent following initial 

antineoplastic therapy. 

13.14 Lungs. 

A. Non-small-cell carcinoma—inoperable, 

unresectable, recurrent, or metastatic disease 

to or beyond the hilar nodes.

OR

B. Small-cell (oat cell) carcinoma. 

13.15 Pleura or mediastinum. 

A. Malignant mesothelioma of pleura.

OR

B. Tumors of the mediastinum, as 

described in 1 or 2: 

1. With metastases to or beyond the 

regional lymph nodes. 

2. Persistent or recurrent following initial 

antineoplastic therapy. 

13.16 Esophagus or stomach. 

A. Carcinoma or sarcoma of the esophagus.

OR

B. Carcinoma or sarcoma of the stomach, 

as described in 1 or 2: 

1. Inoperable, unresectable, extending to 

surrounding structures, or recurrent. 

2. With metastases to or beyond the 

regional lymph nodes. 

13.17 Small intestine—carcinoma, 

sarcoma, or carcinoid. 

A. Inoperable, unresectable, or recurrent.

OR

B. With metastases beyond the regional 

lymph nodes. 

13.18 Large intestine (from ileocecal 

valve to and including anal canal). 

A. Adenocarcinoma that is inoperable, 

unresectable, or recurrent.

OR

B. Squamous cell carcinoma of the anus, 

recurrent after surgery.

OR

C. With metastases beyond the regional 

lymph nodes. 

13.19 Liver or gallbladder—tumors of the 

liver, gallbladder, or bile ducts. 

13.20 Pancreas.

A. Carcinoma (except islet cell carcinoma). 

OR

B. Islet cell carcinoma that is inoperable or 

unresectable and physiologically active.

13.21 Kidneys, adrenal glands, or 

ureters—carcinoma. 

A. Inoperable, unresectable, or recurrent.

OR

B. With metastases to or beyond the 

regional lymph nodes. 

13.22 Urinary bladder—carcinoma. 

A. With infiltration beyond the bladder 

wall.

OR

B. Recurrent after total cystectomy.

OR

C. Inoperable or unresectable.

OR

D. With metastases to or beyond the 

regional lymph nodes. 

13.23 Cancers of the female genital 

tract—carcinoma or sarcoma. 

A. Uterus (corpus), as described in 1, 2, or 

3: 

1. Invading adjoining organs. 

2. With metastases to or beyond the 

regional lymph nodes. 

3. Persistent or recurrent following initial 

antineoplastic therapy.

OR

B. Uterine cervix, as described in 1 or 2: 

1. Extending to the pelvic wall, lower 

portion of the vagina, or adjacent or distant 

organs. 

2. Persistent or recurrent following initial 

antineoplastic therapy.

OR

C. Vulva, as described in 1, 2, or 3: 

1. Invading adjoining organs. 

2. With metastases to or beyond the 

regional lymph nodes. 

3. Persistent or recurrent following initial 

antineoplastic therapy.

OR

D. Fallopian tubes, as described in 1 or 2: 

1. Extending to the serosa or beyond. 

2. Persistent or recurrent following initial 

antineoplastic therapy.

OR

E. Ovaries, as described in 1 or 2: 

1. All tumors except germ-cell tumors, 

with at least one of the following: 

a. Tumor extension beyond the pelvis; for 

example, tumor implants on peritoneal, 

omental, or bowel surfaces. 

b. Metastases to or beyond the regional 

lymph nodes. 

c. Ruptured ovarian capsule, tumor on the 

serosal surface of the ovary, ascites with 

malignant cells, or positive peritoneal 

washings. 

d. Recurrent following initial 

antineoplastic therapy. 

2. Germ-cell tumors—progressive or 

recurrent following initial antineoplastic 

therapy. 

13.24 Prostate gland—carcinoma. 

A. Progressive or recurrent despite initial 

hormonal intervention.

OR

B. With visceral metastases. 

13.25 Testicles—tumor with metastatic 

disease progressive or recurrent following 

initial chemotherapy. 

13.26 Penis—carcinoma with metastases 

to or beyond the regional lymph nodes. 

13.27 Primary site unknown after 

appropriate search for primary—metastatic 

carcinoma or sarcoma, except for solitary 

squamous cell carcinoma in the neck. 

13.28 Malignant neoplastic diseases 

treated by bone marrow or stem cell 

transplantation. (See 13.00L.) 

A. Allogeneic transplantation. Consider 

under a disability until at least 12 months 

from the date of transplantation. Thereafter, 

evaluate any residual impairment(s) under 

the criteria for the affected body system.

67036 Federal Register / Vol. 69, No. 219 / Monday, November 15, 2004 / Rules and Regulations 

OR

B. Autologous transplantation. Consider 

under a disability until at least 12 months 

from the date of the first treatment under the 

treatment plan that includes transplantation. 

Thereafter, evaluate any residual 

impairment(s) under the criteria for the 

affected body system.

* * * * *

Part B

* * * * *

107.00 Hematological Disorders

* * * * *

113.00 Malignant Neoplastic Diseases

* * * * *

107.00 HEMATOLOGICAL DISORDERS

* * * * *

C. [removed]

* * * * *

107.11 [removed]

* * * * *

111.00 NEUROLOGICAL

* * * * *

E. Brain tumors. We evaluate malignant 

brain tumors under the criteria in 113.13. For 

benign brain tumors, we determine the 

severity and duration of the impairment on 

the basis of symptoms, signs, and laboratory 

findings (111.05).

* * * * *

111.05 Benign brain tumors. Evaluate 

under 111.02, 111.03, 111.06, 111.09 or the 

criteria of the affected body system.

* * * * *

113.00 MALIGNANT NEOPLASTIC 

DISEASES 

A. What impairments do these listings 

cover? We use these listings to evaluate all 

malignant neoplasms except certain 

neoplasms associated with human 

immunodeficiency virus (HIV) infection. We 

use the criteria in 114.08E to evaluate 

carcinoma of the cervix, Kaposi’s sarcoma, 

lymphoma, and squamous cell carcinoma of 

the anus if you also have HIV infection. 

B. What do we consider when we evaluate 

malignant neoplastic diseases under these 

listings? We consider factors such as the: 

1. Origin of the malignancy. 

2. Extent of involvement. 

3. Duration, frequency, and response to 

antineoplastic therapy. Antineoplastic 

therapy means surgery, irradiation, 

chemotherapy, hormones, immunotherapy, 

or bone marrow or stem cell transplantation. 

When we refer to surgery as an antineoplastic 

treatment, we mean surgical excision for 

treatment, not for diagnostic purposes. 

4. Effects of any post-therapeutic residuals. 

C. How do we apply these listings? We 

apply the criteria in a specific listing to a 

malignancy originating from that specific 

site. 

D. What evidence do we need?

1. We need medical evidence that specifies 

the type, extent, and site of the primary, 

recurrent, or metastatic lesion. In the rare 

situation in which the primary site cannot be 

identified, we will use evidence 

documenting the site(s) of metastasis to 

evaluate the impairment under 13.27 in part 

A. 

2. For operative procedures, including a 

biopsy or a needle aspiration, we generally 

need a copy of both the: 

a. Operative note. 

b. Pathology report. 

3. When we cannot get these documents, 

we will accept the summary of 

hospitalization(s) or other medical reports. 

This evidence should include details of the 

findings at surgery and, whenever 

appropriate, the pathological findings. 

4. In some situations we may also need 

evidence about recurrence, persistence, or 

progression of the malignancy, the response 

to therapy, and any significant residuals. (See

113.00G.) 

E. When do we need longitudinal evidence?

1. Tumors with distant metastases. Most 

malignant tumors of childhood consist of a 

local lesion with metastases to regional 

lymph nodes and, less often, distant 

metastases. We generally do not need 

longitudinal evidence for tumors that have 

metastasized beyond the regional lymph 

nodes because these tumors usually meet the 

requirements of a listing. Exceptions are for 

tumors with distant metastases that are 

expected to respond to antineoplastic 

therapy. For these exceptions, we usually 

need a longitudinal record of 3 months after 

therapy starts to determine whether the 

intended effect of therapy has been achieved 

and is likely to persist. 

2. Other malignancies. When there are no 

distant metastases, many of the listings 

require that we consider your response to 

initial antineoplastic therapy; that is, the 

initial planned treatment regimen. This 

therapy may consist of a single modality or 

a combination of modalities (multimodal) 

given in close proximity as a unified whole, 

and is usually planned before any 

treatment(s) is initiated. Examples of 

multimodal therapy include: 

a. Surgery followed by chemotherapy or 

radiation.

b. Chemotherapy followed by surgery. 

c. Chemotherapy and concurrent radiation. 

3. Types of treatment. Whenever the initial 

planned therapy is a single modality, enough 

time must pass to allow a determination 

about whether the therapy will achieve its 

intended effect. If the treatment fails, the 

failure will often happen within 6 months 

after treatment starts, and there will often be 

a change in the treatment regimen. Whenever 

the initial planned therapy is multimodal, a 

determination about the effectiveness of the 

therapy usually cannot be made until the 

effects of all the planned modalities can be 

determined. In some cases, we may need to 

defer adjudication until the effectiveness of 

therapy can be assessed. However, we do not 

need to defer adjudication to determine 

whether the therapy will achieve its intended 

effect if we can make a fully favorable 

determination or decision based on the 

length and effects of therapy, or the residuals 

of the malignancy or therapy (see 113.00G). 

F. How do we evaluate impairments that 

do not meet one of the malignant neoplastic 

diseases listings?

1. These listings are only examples of 

malignant neoplastic diseases that we 

consider severe enough to result in marked 

and severe functional limitations. If your 

impairment(s) does not meet the criteria of 

any of these listings, we must also consider 

whether you have an impairment(s) that 

meets the criteria of a listing in another body 

system. 

2. If you have a severe medically 

determinable impairment(s) that does not 

meet a listing, we will determine whether 

your impairment(s) medically equals a 

listing. (See §§ 404.1526 and 416.926.) If it 

does not, we will also consider whether you 

have an impairment(s) that functionally 

equals the listings. (See § 416.926a.) We use 

the rules in § 416.994a when we decide 

whether you continue to be disabled. 

G. How do we consider the effects of 

therapy?

1. How we consider the effects of therapy 

under the listings. In many cases, 

malignancies meet listing criteria only if the 

therapy does not achieve the intended effect: 

the malignancy persists, progresses, or recurs 

despite treatment. However, as explained in 

the following paragraphs, we will not delay 

adjudication if we can make a fully favorable 

determination or decision based on the 

evidence in the case record. 

2. Effects can vary widely.

a. Because the therapy and its toxicity may 

vary widely, we consider each case on an 

individual basis. We will request a specific 

description of the therapy, including these 

items: 

i. Drugs given. 

ii. Dosage. 

iii. Frequency of drug administration. 

iv. Plans for continued drug 

administration. 

v. Extent of surgery. 

vi. Schedule and fields of radiation 

therapy. 

b. We will also request a description of the 

complications or adverse effects of therapy, 

such as the following: 

i. Continuing gastrointestinal symptoms. 

ii. Persistent weakness. 

iii. Neurological complications.

iv. Cardiovascular complications. 

v. Reactive mental disorders. 

3. Effects of therapy may change. Because 

the severity of the adverse effects of 

antineoplastic therapy may change during 

treatment, enough time must pass to allow us 

to evaluate the therapy’s effect. The residual 

effects of treatment are temporary in most 

instances. But on occasion, the effects may be 

disabling for a consecutive period of at least 

12 months. 

4. When the initial antineoplastic therapy 

is effective. We evaluate any post-therapeutic 

residual impairment(s) not included in these 

listings under the criteria for the affected 

body system. We must consider any 

complications of therapy. When the residual 

impairment(s) does not meet a listed 

impairment, we must consider whether it 

medically equals a listing, or, as appropriate, 

functionally equals the listings. 

H. How long do we consider your 

impairment to be disabling?

1. In some listings, we specify that we will 

consider your impairment to be disabling 

until a particular point in time (for example, 

at least 12 months from the date of 

diagnosis). We may consider your 

impairment to be disabling beyond this point

Federal Register / Vol. 69, No. 219 / Monday, November 15, 2004 / Rules and Regulations 67037

when the medical and other evidence 

justifies it. 

2. When a listing does not contain such a 

specification, we will consider an 

impairment(s) that meets or medically equals 

a listing in this body system to be disabling 

until at least 3 years after onset of complete 

remission. When the impairment(s) has been 

in complete remission for at least 3 years, 

that is, the original tumor and any metastases 

have not been evident for at least 3 years, the 

impairment(s) will no longer meet or equal 

the criteria of a listing in this body system. 

3. Following the appropriate period, we 

will consider any residuals, including 

residuals of the malignancy or therapy (see

113.00G), in determining whether you are 

disabled. 

I. What do these terms in the listings 

mean?

1. Persistent: Failure to achieve a complete 

remission. 

2. Progressive: The malignancy became 

more extensive after treatment. 

3. Recurrent, relapse: A malignancy that 

had been in complete remission or entirely 

removed by surgery has returned. 

J. Can we establish the existence of a 

disabling impairment prior to the date of the 

evidence that shows the malignancy satisfies 

the criteria of a listing? Yes. We will consider 

factors such as: 

1. The type of malignancy and its location. 

2. The extent of involvement when the 

malignancy was first demonstrated. 

3. Your symptoms. 

K. How do we evaluate specific malignant 

neoplastic diseases?

1. Lymphoma.

a. Listing 113.05 provides criteria for 

evaluating intermediate or high grade 

lymphomas that have not responded to 

antineoplastic therapy. Low grade or indolent 

lymphomas are rare in children. We will 

evaluate low grade or indolent lymphomas 

under 13.05 in part A. 

b. We consider Hodgkin’s disease that 

recurs more than 12 months after completing 

initial antineoplastic therapy to be a new 

disease rather than a recurrence. 

c. Many children with lymphoma are 

treated according to a long-term protocol that 

can result in significant adverse medical, 

social, and emotional consequences. (See

113.00G.) 

2. Leukemia.

a. Acute leukemia. The initial diagnosis of 

acute leukemia, including the accelerated or 

blast phase of chronic myelogenous 

(granulocytic) leukemia, is based upon 

definitive bone marrow examination. 

Additional diagnostic information is based 

on chromosomal analysis, cytochemical and 

surface marker studies on the abnormal cells, 

or other methods consistent with the 

prevailing state of medical knowledge and 

clinical practice. Recurrent disease must be 

documented by peripheral blood, bone 

marrow, or cerebrospinal fluid examination. 

The initial and follow-up pathology reports 

should be included. 

b. Chronic myelogenous leukemia (CML).

The diagnosis of CML should be based upon 

documented granulocytosis, including 

immature forms such as differentiated or 

undifferentiated myelocytes and myeloblasts, 

and a chromosomal analysis that 

demonstrates the Philadelphia chromosome. 

In the absence of a chromosomal analysis, or 

if the Philadelphia chromosome is not 

present, the diagnosis may be made by other 

methods consistent with the prevailing state 

of medical knowledge and clinical practice.

c. Juvenile chronic myelogenous leukemia 

(JCML). JCML is a rare, Philadelphiachromosome-negative childhood leukemia 

that is aggressive and clinically similar to 

acute myelogenous leukemia. We evaluate 

JCML under 113.06A. 

d. Elevated white cell count. In cases of 

chronic leukemia, an elevated white cell 

count, in itself, is not ordinarily a factor in 

determining the severity of the impairment. 

3. Malignant solid tumors. The tumors we 

consider under 113.03 include the 

histiocytosis syndromes except for solitary 

eosinophilic granuloma. Therefore, we will 

not evaluate brain tumors (see 113.13) or 

thyroid tumors (see 113.09) under this 

listing. 

4. Brain tumors. We use the criteria in 

113.13 to evaluate malignant brain tumors. 

We will evaluate any complications of 

malignant brain tumors, such as resultant 

neurological or psychological impairments, 

under the criteria for the affected body 

system. We evaluate benign brain tumors 

under 111.05. 

5. Retinoblastoma. The treatment for 

bilateral retinoblastoma usually results in a 

visual impairment. We will evaluate any 

resulting visual impairment under 102.02. 

L. How do we evaluate malignant 

neoplastic diseases treated by bone marrow 

or stem cell transplantation? Bone marrow or 

stem cell transplantation is performed for a 

variety of malignant neoplastic diseases. 

1. Acute leukemia (including T-cell 

lymphoblastic lymphoma and JCML) or 

accelerated or blast phase of CML. If you 

undergo bone marrow or stem cell 

transplantation for any of these disorders, we 

will consider you to be disabled until at least 

24 months from the date of diagnosis or 

relapse, or at least 12 months from the date 

of transplantation, whichever is later. 

2. Lymphoma or chronic phase of CML. If 

you undergo bone marrow or stem cell 

transplantation for any of these disorders, we 

will consider you to be disabled until at least 

12 months from the date of transplantation. 

3. Evaluating disability after the 

appropriate time period has elapsed. We 

consider any residual impairment(s), such as 

complications arising from: 

a. Graft-versus-host (GVH) disease. 

b. Immunosuppressant therapy, such as 

frequent infections. 

c. Significant deterioration of other organ 

systems. 

113.01 Category of Impairments, Malignant 

Neoplastic Diseases 

113.03 Malignant solid tumors. Consider 

under a disability: 

A. For 2 years from the date of initial 

diagnosis. Thereafter, evaluate any residual 

impairment(s) under the criteria for the 

affected body system.

OR

B. For 2 years from the date of recurrence 

of active disease. Thereafter, evaluate any 

residual impairment(s) under the criteria for 

the affected body system. 

113.05 Lymphoma (excluding T-cell 

lymphoblastic lymphoma—113.06). (See

113.00K1.) 

A. Non-Hodgkins lymphoma, including 

Burkitt’s and anaplastic large cell. Persistent 

or recurrent following initial antineoplastic 

therapy.

OR

B. Hodgkin’s disease with failure to 

achieve clinically complete remission, or 

recurrent disease within 12 months of 

completing initial antineoplastic therapy.

OR

C. With bone marrow or stem cell 

transplantation. Consider under a disability 

until at least 12 months from the date of 

transplantation. Thereafter, evaluate any 

residual impairment(s) under the criteria of 

the affected body system. 

113.06 Leukemia. (See 113.00K2.) 

A. Acute leukemia (including T-cell 

lymphoblastic lymphoma and juvenile 

chronic myelogenous leukemia (JCML)). 

Consider under a disability until at least 24 

months from the date of diagnosis or relapse, 

or at least 12 months from the date of bone 

marrow or stem cell transplantation, 

whichever is later. Thereafter, evaluate any 

residual impairment(s) under the criteria for 

the affected body system.

OR

B. Chronic myelogenous leukemia (except 

JCML), as described in 1 or 2: 

1. Accelerated or blast phase. Consider 

under a disability until at least 24 months 

from the date of diagnosis or relapse, or at 

least 12 months from the date of bone 

marrow or stem cell transplantation, 

whichever is later. Thereafter, evaluate any 

residual impairment(s) under the criteria for 

the affected body system. 

2. Chronic phase, as described in a or b: 

a. Consider under a disability until at least 

12 months from the date of bone marrow or 

stem cell transplantation. Thereafter, 

evaluate any residual impairment(s) under 

the criteria for the affected body system. 

b. Progressive disease following initial 

antineoplastic therapy. 

113.09 Thyroid gland.

A. Anaplastic (undifferentiated) carcinoma.

OR

B. Carcinoma with metastases beyond the 

regional lymph nodes progressive despite 

radioactive iodine therapy. 

113.12 Retinoblastoma.

A. With extension beyond the orbit.

OR

B. Persistent or recurrent following initial 

antineoplastic therapy.

OR

C. With regional or distant metastases. 

113.13 Brain tumors. (See 113.00K4.) 

Highly malignant tumors, such as Grades III 

and IV astrocytomas, glioblastoma 

multiforme, ependymoblastoma, 

medulloblastoma or other primitive 

neuroectodermal tumors (PNETs) with 

documented metastases, diffuse intrinsic 

brain stem gliomas, or primary sarcomas. 

113.21 Neuroblastoma.

A. With extension across the midline.

67038 Federal Register / Vol. 69, No. 219 / Monday, November 15, 2004 / Rules and Regulations 

OR

B. With distant metastases.

OR

C. Recurrent.

OR

D. With onset at age 1 year or older.

* * * * *

[FR Doc. 04–24897 Filed 11–12–04; 8:45 am] 

BILLING CODE 4191–02–P