Revised Medical Criteria for Evaluating Malignant Neoplastic Diseases, 22871-22877 [E8-9170]

Agencies

• Social Security Administration

[Federal Register Volume 73, Number 82 (Monday, April 28, 2008)]
[Proposed Rules]
[Pages 22871-22877]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-9170]


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SOCIAL SECURITY ADMINISTRATION

20 CFR Part 404

[Docket No. SSA-2007-0066]
RIN 0960-AG57


Revised Medical Criteria for Evaluating Malignant Neoplastic 
Diseases

AGENCY: Social Security Administration.

ACTION: Notice of proposed rulemaking.

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SUMMARY: We propose to revise the criteria in parts A and B of the 
Listing of Impairments (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 proposed revisions reflect our 
adjudicative experience, as well as advances in medical knowledge, 
treatment, and methods of evaluating malignant neoplastic diseases.

DATES: To be sure that your comments are considered, we must receive 
them by June 27, 2008.

ADDRESSES: You may submit comments by any of the following methods. 
Regardless of which method you choose, to ensure that we can associate 
your comments with the correct regulation for consideration, state that 
your comments refer to Docket No. SSA-2007-0066:
     Federal eRulemaking Portal at https://www.regulations.gov. 
(This is the preferred method for submitting your comments.) In the 
Comment or Submission section, type ``SSA-2007-0066'', select ``Go'', 
and then click ``Send a Comment or Submission'' under the highlighted 
SSA-2007-00766 text.
     Telefax to (410) 966-2830.
     Letter to the Commissioner of Social Security, P.O. Box 
17703, Baltimore, MD 21235-7703.
     Deliver your comments to the Office of Regulations, Social 
Security Administration, 922 Altmeyer Building, 6401 Security 
Boulevard, Baltimore, MD 21235-6401, between 8 a.m. and 4:30 p.m. on 
regular business days.
    Comments are posted on the Federal eRulemaking Portal, or you may 
inspect them on regular business days by making arrangements with the 
contact person shown in this preamble.

FOR FURTHER INFORMATION CONTACT: Rosemarie Greenwald, Social Insurance 
Specialist, Social Security Administration, Office of Regulations, 960 
Altmeyer Building, 6401 Security Boulevard, Baltimore, MD 21235-6401. 
Call 410-966-7813 for further information about these proposed rules. 
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 https://
www.socialsecurity.gov.

SUPPLEMENTARY INFORMATION:

Electronic Version

    The electronic file of this document is available on the date of 
publication in the Federal Register at https://www.gpoaccess.gov/fr/
index.html.

Why are we proposing to revise the adult listings for malignant 
neoplastic diseases?

    We last published final rules revising the listings for malignant 
neoplastic diseases in the Federal Register on November 15, 2004 (69 FR 
67017, corrected at 70 FR 15227). In those rules, we indicated that we 
intended to monitor these listings and to update the criteria for any 
malignant neoplastic disease contained in these listings as the need 
arose. We are proposing changes to the listing criteria for malignant 
neoplastic diseases to reflect our adjudicative experience since we 
last issued final rules on this body system and to reflect advances in 
medical knowledge, treatment, and methods of evaluating malignant 
neoplastic diseases. We are also proposing changes to the introductory 
text to these listings

[[Page 22872]]

to provide additional information about how we evaluate malignant 
neoplastic diseases and to update medical terminology. Many of these 
proposed changes are based on the answers we provided to our 
adjudicators who had questions about the current rules.

How do we propose to revise the introductory text to the malignant 
neoplastic diseases listings for adults?

    We propose to make the following changes to 13.00I, ``What do these 
terms in the listings mean?''
     Expand the definition of ``inoperable'' in current 13.00I1 
by adding a reference to the term ``neoadjuvant therapy'' and defining 
it. ``Neoadjuvant therapy'' is antineoplastic therapy, such as 
chemotherapy or radiation, that you receive before surgery in order to 
reduce the size of your tumor. In current 13.00I1, we explain that the 
determination of whether a tumor is inoperable ``usually occurs before 
attempts to shrink the tumor with chemotherapy or radiation''; that is, 
before the administration of neoadjuvant therapy. However, it is 
becoming more common in medical practice to wait until neoadjuvant 
therapy is completed before determining whether a tumor is inoperable. 
Therefore, we propose to revise current 13.00I1 to define the term 
``neoadjuvant therapy'' and to explain that the determination of 
whether a tumor is inoperable ``may be made before or after neoadjuvant 
therapy,'' to be consistent with current medical practice. Lastly, we 
propose to make minor editorial changes to clarify our list of examples 
of when a tumor may be considered inoperable.
     Expand the definition of ``unresectable'' in current 
13.00I2 (proposed 13.00I6) by defining the term ``adjuvant therapy'' 
and explaining how the use of this type of therapy relates to a 
determination of whether a tumor is unresectable. ``Adjuvant therapy'' 
is antineoplastic therapy, such as chemotherapy or radiation, that you 
receive after you have surgery in order to eliminate any remaining 
cancer cells and lessen the chance of recurrence.
     Add a definition for ``metastases'' (proposed 13.00I2). In 
the proposed definition, we explain that ``metastases'' means spread of 
tumor cells by blood, lymph, or other body fluid. We also explain that 
``metastases'' does not include the spread of tumor cells by direct 
extension of the tumor to other tissue or organs.
     Reorganize the section to present the terms in 
alphabetical order for easier reference.
    We propose to make the following changes to 13.00K, ``How do we 
evaluate specific malignant neoplastic diseases?''
     Revise current 13.00K1a and 13.00K1b to refer to 
``indolent lymphoma'' instead of ``low grade or indolent lymphoma'' to 
reflect current medical terminology.
     Expand current 13.00K2a to recognize that testicular 
biopsy is an acceptable method of documenting recurrent leukemia.
     Revise current 13.00K6 to clarify that we consider a brain 
tumor to be malignant if it is classified as grade II or higher under 
the World Health Organization's (WHO's) classification of tumors of the 
central nervous system published in 2007. (See References at the end of 
this preamble.) For purposes of determining disability, we do not 
consider grade I tumors to be malignant because they are usually 
associated with long-term survival, even in the rare situation in which 
they progress or recur following initial antineoplastic therapy. 
Although we would not evaluate grade I brain tumors under the listings 
for malignant neoplastic diseases, we would evaluate them under listing 
11.05.

How do we propose to revise the criteria in the malignant neoplastic 
listings for adults?

    We propose to revise current listing 13.02C, which applied to 
recurrent soft tissue tumors of the head and neck, except for salivary 
or thyroid gland tumors. The current listing excludes local vocal cord 
recurrence. We propose to revise the listing to specify that it does 
not include ``recurrence in the true vocal cord.'' The proposed change 
more accurately reflects our intent. Accordingly, under our proposal as 
under our current rules, recurrence of the disease in the ``false'' 
vocal cord would meet listing 13.02C.
    We propose to expand the criteria in current listing 13.03B2 for 
melanoma with palpable nodal metastases or metastases to adjacent skin 
(satellite lesions) or elsewhere. A palpable lymph node is a type of 
``clinically apparent'' lymph node. As defined by the American Joint 
Committee on Cancer (AJCC) in the sixth edition of the Cancer Staging 
Handbook (see References at the end of this preamble), ``clinically 
apparent'' means ``detected by imaging studies (excluding 
lymphoscintigraphy) or by clinical examination.'' Current medical 
literature establishes that a finding of melanoma with metastases to 
one or more ``clinically apparent'' lymph nodes is equivalent in 
severity to palpable nodal metastases. The literature also establishes 
that a finding of melanoma with metastases to four or more lymph nodes 
that are not clinically apparent is equivalent in severity to palpable 
nodal metastases. Therefore, we propose to expand the current listing 
to include these criteria. We also propose to make a minor editorial 
change to clarify that ``elsewhere'' means ``distant sites.''
    We propose to make the following changes to current listing 13.05A 
for non-Hodgkin's lymphoma:
     Replace the terms ``intermediate or high-grade'' and 
``low-grade or indolent'' with the terms ``aggressive'' and 
``indolent,'' respectively, to reflect current medical terminology;
     Clarify that mycosis fungoides is an indolent lymphoma by 
removing it from the heading of the listing and including it as an 
example in proposed listing 13.05A2; and
     Add an example of an aggressive lymphoma and another 
example of an indolent lymphoma for clarity.
    Current listing 13.09B, for carcinoma of the thyroid gland with 
metastases beyond the regional lymph nodes, provides that we consider 
this disease to be of listing-level severity when it progresses despite 
radioactive iodine treatment. We propose to add a criterion, proposed 
listing 13.09C, for medullary carcinoma of the thyroid gland with 
metastases beyond the regional lymph nodes. Because medullary carcinoma 
is not treated with radioactive iodine, it cannot meet current listing 
13.09B.
    Although we are adding this criterion for adults, we are not adding 
a comparable criterion for children since medullary carcinoma is 
extremely rare in children. Instead, we are proposing to include 
guidance in proposed 113.00K4, the introductory text to the childhood 
listings, indicating that we will use listing 13.09C in the rare case 
in which a child has medullary carcinoma of the thyroid gland.
    When we published current listing 13.10B, for breast carcinoma, the 
spread of breast carcinoma to the supraclavicular nodes was considered 
to be distant metastases. However, the medical community no longer 
considers this to represent distant metastases for breast carcinoma. 
Therefore, we propose to add a criterion to current listing 13.10B for 
metastases to the supraclavicular nodes to make it clear that we will 
continue to consider metastases to the supraclavicular nodes to be of 
listing-level severity.
    We also propose to add criteria for breast cancer with metastases 
to the infraclavicular nodes or to 10 or more axillary nodes. In light 
of the current

[[Page 22873]]

medical literature, we believe that these findings are indicative of 
listing-level severity as well.
    We propose to remove the words ``carcinoma or'' from the heading of 
current listing 13.11, for malignant neoplastic diseases of the 
skeletal system, to correct an editorial error. A carcinoma is a 
malignant tumor that begins in the skin or in tissues that line or 
cover internal organs. Therefore, by definition, a carcinoma cannot 
originate in the skeletal system.
    We propose to make a minor editorial change to current listing 
13.13A1 for highly malignant central nervous system neoplasms to 
clarify that the requirement for documented metastases applies only to 
medulloblastoma or other primitive neuroectodermal tumors (PNETs), and 
not to grades III and IV astrocytomas, glioblastoma multiforme, and 
ependymoblastoma. This is what we intend in the current rule, but we 
wanted to make the current sentence structure clearer. Therefore, we 
propose to reorganize the sentence for clarity. We also propose to add 
the word ``malignant'' to current listing 13.13A, for central nervous 
system neoplasms. This would clarify that we do not evaluate benign 
tumors under this listing.
    We propose to expand the criteria in current listing 13.14, for 
carcinoma of the lungs, by adding proposed listing 13.14C. The proposed 
listing would provide that an individual with carcinoma of the superior 
sulcus (including Pancoast tumors) who receives multimodal 
antineoplastic therapy would be disabled for at least 18 months from 
the date of diagnosis. This criterion recognizes the debilitating 
effects of, and the length of time needed to recover from, treatment 
for this disease. At the end of the 18-month period, we would evaluate 
any residual impairment(s) under the criteria for the affected body 
system.
    We propose to remove current listing 13.23E1c, for ovarian cancer 
with ruptured ovarian capsule, tumor on the serosal surface of the 
ovary, ascites with malignant cells, or positive peritoneal washings. 
Current medical literature indicates improved prognoses for these 
clinical findings. Consequently, we believe that these clinical 
findings do not usually represent an impairment of listing-level 
severity. We will continue to consider ovarian cancer to be of listing-
level severity if it meets the other criteria in current listing 
13.23E1; that is, there is tumor extension beyond the pelvis (current 
listing 13.23E1a), there are metastases to or beyond the regional lymph 
nodes (current listing 13.23E1b), or the disease is recurrent following 
initial antineoplastic therapy (current listing 13.23E1d). Because of 
this proposed deletion, we would redesignate current listing 13.23E1d 
as listing 13.23E1c.
    We propose to revise listing 13.24B for carcinoma of the prostate 
gland to clarify that ``visceral metastases'' means metastases to 
internal organs.
    We propose to make a minor editorial change to current listing 
13.27 for malignant tumors for which the primary site of origin is 
unknown. The current listing provides that these tumors are of listing-
level severity ``except for solitary squamous cell carcinoma in the 
neck.'' We propose to revise this language to read ``except for 
squamous cell carcinoma confined to the neck nodes'' for clarity.

How do we propose to revise the introductory text to the malignant 
neoplastic diseases listings for children?

    We propose to make the following changes in 113.00 to correspond to 
changes we propose to make in 13.00:
     Add a definition of ``metastases'' (proposed 113.00I1);
     Reorganize section 113.00I to present the terms in 
alphabetical order for easier reference;
     Revise the guidance on lymphoma in current 113.00K1a to 
refer to ``aggressive'' lymphoma and ``indolent'' lymphoma and to make 
minor editorial changes;
     Revise current 113.00K2a to add testicular biopsy as an 
acceptable method of documenting recurrent leukemia; and
     Revise current 113.00K4 (proposed 113.00K5) to clarify 
when we consider a brain tumor to be malignant.
    We also propose to add a new 113.00K4 to provide guidance on 
evaluating thyroid tumors. As we indicated above, we are not proposing 
to add a listing for medullary carcinoma of the thyroid gland to the 
childhood listings because this disease is extremely rare in children. 
Instead, we propose to add guidance indicating that we will evaluate 
this disease in children under listing 13.09C. Because of this 
addition, we would redesignate current 113.00K4 and current 113.00K5 as 
113.00K5 and 113.00K6.

How do we propose to revise the criteria in the malignant neoplastic 
listings for children?

    We propose to revise current listing 113.13, for brain tumors, to 
be consistent with the change we are proposing in current listing 
13.13A1.

What programs would these proposed regulations affect?

    These proposed rules would affect disability determinations and 
decisions that we make under titles II and 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 or 
title XVI, these proposed rules would 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, and
     Widows, widowers, and surviving divorced spouses (see 
Sec.  404.336) of insured workers.
    Under title XVI of the Act, we provide for supplemental security 
income (SSI) payments on the basis of disability if you are disabled 
and have limited income and resources.

How do we define disability?

    Under both the title II and title XVI programs, disability must be 
the result of any medically determinable physical or mental impairment 
or combination of impairments that is expected to result in death or 
which has lasted or can be expected to last for a continuous period of 
at least 12 months. Our definitions of disability are shown in the 
following table:

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


[[Page 22874]]

How do we decide whether you are disabled?

    If you are applying for benefits under title II of the Act, or if 
you are an adult applying for payments under title XVI of the Act, we 
use a five-step ``sequential evaluation process'' to decide whether you 
are disabled. We describe this five-step process in our regulations at 
Sec. Sec.  404.1520 and 416.920. We follow the five steps in order and 
stop as soon as we can make a determination or decision. The steps are:
    1. Are you working, and is the work you are doing substantial 
gainful activity? If you are working and the work you are doing is 
substantial gainful activity, we will find that you are not disabled, 
regardless of your medical condition or your age, education, and work 
experience. If you are not, we will go on to step 2.
    2. Do you have a ``severe'' impairment? If you do not have an 
impairment or combination of impairments that significantly limits your 
physical or mental ability to do basic work activities, we will find 
that you are not disabled. If you do, we will go on to step 3.
    3. Do you have an impairment(s) that meets or medically equals the 
severity of an impairment in the listings? If you do, and the 
impairment(s) meets the duration requirement, we will find that you are 
disabled. If you do not, we will go on to step 4.
    4. Do you have the residual functional capacity (RFC) 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 national economy, considering 
your RFC, 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 SSI. If you are already 
receiving benefits, we also use a different sequential evaluation 
process when we decide whether your disability continues. See 
Sec. Sec.  404.1594, 416.924, 416.994, and 416.994a of our regulations. 
However, all of these processes include steps at which we consider 
whether your impairment(s) 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 payments based on disability, the listings 
describe impairments that we consider severe enough to result in marked 
and severe functional limitations. Although the listings are contained 
only in appendix 1 to subpart P of part 404 of our regulations, we 
incorporate them by reference in the SSI program in Sec.  416.925 of 
our regulations and apply them to claims under both title II and title 
XVI of the Act.

How do we use the listings?

    The listings are in two parts. There are listings for adults (part 
A) and for children (part B). If you are an individual age 18 or over, 
we apply the listings in part A when we assess your claim, and we never 
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. Part B contains criteria that apply only to 
individuals who are under age 18. If the criteria in part B do not 
apply, we may use the criteria in part A when those criteria give 
appropriate consideration to the effects of the impairment(s) in 
children. (See Sec. Sec.  404.1525 and 416.925.)
    If your impairment(s) does not meet any listing, we will also 
consider whether it medically equals any listing; that is, whether it 
is as medically severe as an impairment in the listings. (See 
Sec. Sec.  404.1526 and 416.926.)

What if you do not have an impairment(s) that meets or medically equals 
a listing?

    We use the listings only to decide that you are disabled or that 
you are still disabled. We will not deny your claim or decide that you 
no longer qualify for benefits because your impairment(s) does not meet 
or medically equal a listing. If 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.'' 
Likewise, we will not decide that your disability has ended only 
because your impairment(s) no longer meets or medically equals 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 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 your impairment(s) no longer meets or 
medically equals the prior listing, we evaluate your case further to 
determine whether you are currently disabled. We may find that you are 
currently disabled, depending on the full circumstances of your case. 
See Sec. Sec.  404.1594(c)(3)(i) and 416.994(b)(2)(iv)(A). If you are a 
child who is eligible for SSI payments, we follow a similar rule when 
we decide that you have experienced medical improvement in your 
condition(s). See Sec.  416.994a(b)(2).

When will we start to use these rules?

    We will not use these rules until we evaluate the public comments 
we receive on them, determine whether they should be issued as final 
rules, and issue final rules in the Federal Register. If we publish 
final rules, we will explain in the preamble how we will apply them, 
and summarize and respond to the public comments. Until the effective 
date of any final rules, we will continue to use our current rules.

How long would these proposed rules be effective?

    If we publish these proposed rules as final rules, they will remain 
in effect for 8 years after the date they become effective, unless we 
extend them, or revise and issue them again.

Clarity of these Proposed Rules

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

[[Page 22875]]

Regulatory Procedures

Executive Order 12866

    We have consulted with the Office of Management and Budget (OMB) 
and determined that these proposed rules meet the requirements for a 
significant regulatory action under Executive Order 12866, as amended. 
Thus, they were subject to OMB review.
    The Office of the Chief Actuary estimates that these proposed 
rules, if finalized, would reduce the program costs of the Old Age, 
Survivors, and Disability Insurance (OASDI) and the SSI programs, as 
shown in the table below:

   Estimated Net Reductions in OASDI Benefit Payments and Federal SSI
    Payments Due To the Proposed Revision of the Malignant Neoplastic
                Diseases Listings, Fiscal Years 2009-2018
                              (in millions)
------------------------------------------------------------------------
                      Fiscal year                        OASDI     SSI
------------------------------------------------------------------------
2009..................................................       $1    (\1\)
2010..................................................        2    (\1\)
2011..................................................        2    (\1\)
2012..................................................        3       $1
2013..................................................        4        1
2014..................................................        5        1
2015..................................................        6        1
2016..................................................        7        1
2017..................................................        8        1
2018..................................................        9        1
Totals:
    2019-2013.........................................       12        2
    2009-2018.........................................       47       8
------------------------------------------------------------------------
\1\ Reduction in payments of less than $500,000.

Regulatory Flexibility Act

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

Paperwork Reduction Act

    These proposed rules will impose no additional reporting or 
recordkeeping requirements requiring OMB clearance.

References

    During development of these proposed rules, we consulted the 
following information:

Alifano, M., et al., Surgical treatment of superior sulcus tumors, 
Chest, Sep;124(3), 996-1003 (2003).
Archie, V.C. and Thomas, C.R. Jr., Superior sulcus tumors: A mini-
review. The Oncologist, Sep;9(5), 550-555 (2004).
Asher, A., et al., A Primer of Brain Tumors: A Patient's Reference 
Manual, (American Brain Tumor Association, 8th ed. 2004).
Balch, C.M., et al., Final version of the American Joint Committee 
on Cancer Staging System for Cutaneous Melanoma, Journal of Clinical 
Oncology, Aug;19(16), 3635-3648 (2001).
Bell, J., et al., Randomized phase III trial of three versus six 
cycles of adjuvant carboplatin and paclitaxel in early stage 
epithelial ovarian carcinoma: A Gynecologic Oncology Group study, 
Gynecologic Oncology Sep;102(3), 432-439 (2006).
Benamore, R., et al., Does intensive follow-up alter outcomes in 
patients with advanced lung cancer?, Journal of Thoracic Oncology, 
Apr;2(4), 273-281 (2007).
Cliby, W.A., et al., Is it justified to classify patients to stage 
IIIC epithelial ovarian cancer based on nodal involvement only?, 
Gynecologic Oncology, Dec;103(3), 797-801 (2006).
Colombo, N., et al., Ovarian cancer, Critical Reviews in Oncology/
Hematology, Nov;60(2), 159-179 (2006).
Garcia, J.A., et al., Multidisciplinary approach to superior sulcus 
tumors, The Cancer Journal, May/Jun;11(3), 189-197 (2005).
Greene, F.L., et al., Eds., AJCC Cancer Staging Handbook: From the 
AJCC Cancer Staging Manual, (Springer, 6th ed. 2002).
Kestle, J., et al., Juvenile pilocytic astrocytoma of the brainstem 
in children, Journal of Neurosurgery, Aug;101(1 Suppl.), 1-6 (2004).
Kleihues, P, et al., The WHO classification of tumors of the nervous 
system, Journal of Neuropathology and Experimental Neurology, 
Mar;61(3), 215-225 (2002).
Lockwood-Rayermann, S., Survivorship issues in ovarian cancer: A 
review, Oncology Nursing Forum, May;33(3), 553-562 (2006).
Louis, D.N., et al., Eds., WHO Classification of Tumours of the 
Central Nervous System, (International Agency for Research on 
Cancer, 4th ed. 2007).
Marra, A., et al., Induction chemotherapy, concurrent chemoradiation 
and surgery for Pancoast tumour, European Respiratory Journal, 
Jan;29(1), 117-126 (2007).
Morton, D.L. and Cochran, A.J., The case for lymphatic mapping and 
sentinel lymphadenectomy in the management of primary melanoma, 
British Journal of Dermatology, Aug;151(2), 308-319 (2004).
Pectasides, P., et al., Treatment issues in clear cell carcinoma of 
the ovary: A different entity?, The Oncologist, Nov;11(10), 1089-
1094 (2006).
Rao, G.G., et al., Surgical staging of ovarian low malignant 
potential tumors, The Women's Oncology Review, Mar;5(1), 29-30 
(2005).
Shah, H., et al., Brain: The common site of relapse in patients with 
Pancoast or superior sulcus tumors, Journal of Thoracic Oncology, 
Nov;1(9), 1020-1022 (2006).
Shimada, M., et al., Outcome of patients with early ovarian cancer 
undergoing three courses of adjuvant chemotherapy following complete 
surgical staging, International Journal of Gynecological Cancer, 
Jul/Aug;15(4), 601-605 (2006).
Signorelli, M., et al., Conservative management in primary genital 
lymphoma: The role of chemotherapy, Gynecologic Oncology, 
Feb;104(2), 416-421 (2007).
Steliarova, E., et al., Thyroid cancer incidence and survival among 
European children and adolescents (1978-1997): Report from the 
Automated Childhood Cancer Information System project, European 
Journal of Cancer, Sep;42(13), 2150-2169 (2006).
Tanvetyanon, T., et al., Neoadjuvant therapy: An emerging concept in 
oncology, Southern Medical Journal, Mar;98(3), 338-344 (2005).
White, R.R., et al., Long-term survival in 2,505 patients with 
melanoma with regional lymph node metastasis, Annals of Surgery, 
Jun;235(6), 879-887 (2002).
Zhang, M., et al., Prognostic factors responsible for survival in 
sex cord stromal tumors of the ovary--An analysis of 376 women, 
Gynecologic Oncology, Feb;104(2), 396-400 (2007).

    These references are included in the rulemaking record for these 
proposed rules and are available for inspection by interested 
individuals making arrangements with the contact person shown in this 
preamble.

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

List of Subjects in 20 CFR Part 404

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

    Dated: January 29, 2008.
Michael J. Astrue,
Commissioner of Social Security.
    For the reasons set out in the preamble, we propose to amend 
Appendix 1 to subpart P of part 404 of chapter III of title 20 of the 
Code of Federal Regulations 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; sec. 202, Pub. L. 108-203, 118 Stat. 509 (42 
U.S.C. 902 note).
    2. Appendix 1 to subpart P of Part 404 is amended as follows:
    a. Revise the expiration date in item 14 of the introductory text 
before part A of appendix 1.

[[Page 22876]]

    b. Revise paragraph I of section 13.00 of part A of appendix 1.
    c. Amend paragraph K of section 13.00 of part A of appendix 1 by 
revising 13.00K1a, 13.00K1b, the third sentence of 13.00K2a, and 
13.00K6.
    d. Revise listing 13.02C of part A of appendix 1.
    e. Revise listing 13.03B2 of part A of appendix 1.
    f. Amend listing 13.05 of part A of appendix 1 by revising the 
heading and listing 13.05A.
    g. Amend listing 13.09 of part A of appendix 1 by adding the word 
``OR'' and listing 13.09C.
    h. Revise listing 13.10B of part A of appendix 1.
    j. Amend listing 13.11 of part A of appendix 1 by removing the 
words ``carcinoma or.''
    k. Revise listings 13.13A1 and 13.13A2 of part A of appendix 1.
    l. Amend listing 13.14 of part A of appendix 1 by adding the word 
``OR'' and listing 13.14C.
    m. Amend listing 13.23 of part A of appendix 1 by removing current 
listing 13.23E1c and redesignating current listing 13.23E1d as 
listing13.23E1c.
    n. Revise listing 13.24B of part A of appendix 1.
    o. Revise listing 13.27 of part A of appendix 1.
    p. Revise paragraph I of section 113.00 of part B of appendix 1.
    q. Amend paragraph K of section 113.00 of part B of appendix 1 by 
revising 113.00K1a and the third sentence of 113.00K2a, redesignating 
current 113.00K4 and 113.00K5 as 113.00K5 and 113.00K6, respectively, 
adding new 113.00K4, and revising newly designated 113.00K5.
    r. Revise listing 113.13 of part B of appendix 1.
    The revised text is set forth as follows:

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

* * * * *
    14. Malignant Neoplastic Diseases (13.00 and 113.00): (Insert 
date 8 years from the effective date of the final rules.)
* * * * *
    Part A
* * * * *
    13.00 MALIGNANT NEOPLASTIC DISEASES
* * * * *
    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 you cannot tolerate the anesthesia or surgery 
due to another impairment(s). 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 may be 
made before or after the administration of neoadjuvant therapy. 
Neoadjuvant therapy is antineoplastic therapy, such as chemotherapy 
or radiation, given before surgery in order to reduce the size of 
the tumor.
    2. Metastases: The spread of tumor cells by blood, lymph, or 
other body fluid. This term does not include the spread of tumor 
cells by direct extension of the tumor to other tissue or organs.
    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.
    6. 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. 
This term does not include situations in which a tumor is completely 
resected but adjuvant therapy is being administered. Adjuvant 
therapy is antineoplastic therapy, such as chemotherapy or 
radiation, given after surgery in order to eliminate any remaining 
cancer cells and lessen the chance of recurrence.
* * * * *
    K. How do we evaluate specific malignant neoplastic diseases?
    1. Lymphoma.
    a. Many indolent (non-aggressive) lymphomas are controlled by 
well-tolerated treatment modalities, although they may produce 
intermittent symptoms and signs. Therefore, we may defer 
adjudication of these cases for an appropriate period after 
initiation of therapy to determine whether the therapy will achieve 
its intended effect. (See 13.00E3.) For 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 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 solely due to choice, the 
requirements of listing 13.05A2 are not met.
* * * * *
    2. Leukemia.
    a. Acute leukemia. * * * Recurrent disease must be documented by 
peripheral blood, bone marrow, or cerebrospinal fluid examination, 
or by testicular biopsy. * * *
* * * * *
    6. Brain tumors. We use the criteria in 13.13 to evaluate 
malignant brain tumors. We consider a brain tumor to be malignant if 
it is classified as grade II or higher under the World Health 
Organization's (WHO's) classification of tumors of the central 
nervous system (WHO Classification of Tumours of the Central Nervous 
System, 2007). We 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.
* * * * *
    13.01 Category of Impairments, Malignant Neoplastic Diseases
    13.02 Soft tissue tumors of the head and neck (except salivary 
glands--13.08--and thyroid gland--13.09).
* * * * *
    C. Recurrent disease following initial antineoplastic therapy, 
except recurrence in the true vocal cord.
* * * * *
    13.03 Skin.
* * * * *
OR
    B. Melanoma, as described in 1 or 2.
* * * * *
    2. With metastases as described in a, b, or c:
    a. Metastases to one or more clinically apparent nodes; that is, 
nodes that are detected by imaging studies (excluding 
lymphoscintigraphy) or by clinical examination.
    b. If the nodes are not clinically apparent, with metastases to 
four or more nodes.
    c. With metastases to adjacent skin (satellite lesions) or 
distant sites.
* * * * *
    13.05 Lymphoma (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. Aggressive lymphoma (including diffuse large B-cell lymphoma) 
persistent or recurrent following initial antineoplastic therapy.
    2. Indolent lymphoma (including mycosis fungoides and follicular 
small cleaved cell) 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.
* * * * *
    13.09 Thyroid gland.
* * * * *
OR
    C. Medullary carcinoma with metastases beyond the regional lymph 
nodes.
    13.10 Breast. (except sarcoma--13.04). (See 13.00K4.)
* * * * *
    B. Carcinoma with metastases to the supraclavicular or 
infraclavicular nodes, to 10 or more axillary nodes, or with distant 
metastases.
* * * * *
    13.11 Skeletal system--sarcoma.
* * * * *
    13.13 Nervous system. (See 13.00K6.)
    A. Central nervous system malignant neoplasms (brain and spinal 
cord), as described in 1 or 2:

[[Page 22877]]

    1. Highly malignant tumors, such as medulloblastoma or other 
primitive neuroectodermal tumors (PNETs) with documented metastases, 
grades III and IV astrocytomas, glioblastoma multiforme, 
ependymoblastoma, diffuse intrinsic brain stem gliomas, or primary 
sarcomas.
    2. Progressive or recurrent following initial antineoplastic 
therapy.
* * * * *
    13.14 Lungs.
* * * * *
OR
    C. Carcinoma of the superior sulcus (including Pancoast tumors) 
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.
* * * * *
    13.23 Cancers of the female genital tract--carcinoma or sarcoma.
* * * * *
    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. Recurrent following initial antineoplastic therapy.
* * * * *
    13.24 Prostate gland--carcinoma.
* * * * *
    B. With visceral metastases (metastases to internal organs).
* * * * *
    13.27 Primary site unknown after appropriate search for 
primary--metastatic carcinoma or sarcoma, except for squamous cell 
carcinoma confined to the neck nodes.
* * * * *
    Part B
* * * * *
    113.00 MALIGNANT NEOPLASTIC DISEASES
* * * * *
    I. What do these terms in the listings mean?
    1. Metastases: The spread of tumor cells by blood, lymph, or 
other body fluid. This term does not include the spread of tumor 
cells by direct extension of the tumor to other tissue or organs.
    2. Persistent: Failure to achieve a complete remission.
    3. Progressive: The malignancy became more extensive after 
treatment.
    4. Recurrent, relapse: A malignancy that had been in complete 
remission or entirely removed by surgery has returned.
* * * * *
    K. How do we evaluate specific malignant neoplastic diseases?
    1. Lymphoma.
    a. We provide criteria for evaluating aggressive lymphomas that 
have not responded to antineoplastic therapy in 113.05. Indolent 
lymphomas are rare in children. We will evaluate indolent lymphomas 
in children under 13.05 in part A.
* * * * *
    2. Leukemia.
     a. Acute leukemia. * * * Recurrent disease must be documented 
by peripheral blood, bone marrow, or cerebrospinal fluid 
examination, or by testicular biopsy. * * *
* * * * *
    4. Thyroid tumors. We use the criteria in 113.09 to evaluate 
anaplastic carcinoma and carcinoma treated with radioactive iodine. 
Medullary carcinoma of the thyroid gland, which is not treated with 
radioactive iodine, is rare in children. We evaluate medullary 
carcinoma in children under 13.09C in part A.
    5. Brain tumors. We use the criteria in 113.13 to evaluate 
malignant brain tumors. We consider a brain tumor to be malignant if 
it is classified as grade II or higher under the World Health 
Organization's classification of tumors of the central nervous 
system (WHO Classification of Tumours of the Central Nervous System, 
2007). We 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.
* * * * *
    113.01 Category of Impairments, Malignant Neoplastic Diseases
* * * * *
    113.13 Brain tumors. (See 113.00K5.) Highly malignant tumors, 
such as medulloblastoma or other primitive neuroectodermal tumors 
(PNETs) with documented metastases, grades III and IV astrocytomas, 
glioblastoma multiforme, ependymoblastoma, diffuse intrinsic brain 
stem gliomas, or primary sarcomas.
* * * * *
[FR Doc. E8-9170 Filed 4-25-08; 8:45 am]
BILLING CODE 4191-02-P