Revised Medical Criteria for Evaluating Malignant Neoplastic Diseases, 51229-51234 [E9-23896]
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51229
Rules and Regulations
Federal Register
Vol. 74, No. 192
Tuesday, October 6, 2009
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[Corrected]
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Revised Medical Criteria for Evaluating
Malignant Neoplastic Diseases
Social Security Administration.
Final rule.
AGENCY:
ACTION:
SUMMARY: We are revising some of the
criteria in the Listing of Impairments
(the listings) that we use to evaluate
claims involving malignant neoplastic
diseases (cancer) 1 under titles II and
XVI of the Social Security Act (Act). The
revisions reflect our adjudicative
experience, advances in medical
knowledge, diagnosis, and treatment,
and public comments we received in
response to a Notice of Proposed
Rulemaking (NPRM).
DATES: This rule is effective November
5, 2009.
FOR FURTHER INFORMATION CONTACT:
Mark Kuhn, Office of Medical Listings
Improvement, Social Security
Administration, 6401 Security
Boulevard, Baltimore, Maryland 21235–
6401, (410) 965–1020. For information
on eligibility or filing for benefits, call
our national toll-free number, 1–800–
772–1213, or TTY 1–800–325–0778, or
visit our Internet Web site, Social
Security Online, at https://
www.socialsecurity.gov.
SUPPLEMENTARY INFORMATION:
1 ‘‘Malignant neoplastic disease’’ is commonly
known as ‘‘cancer.’’ We use both terms
interchangeably in this document because we
continue to use the technical medical term in the
listings.
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We are revising and making final the
rules for evaluating malignant
neoplastic diseases we proposed in an
NPRM published in the Federal
Register on April 24, 2008 (73 FR
22871). The preamble to the NPRM
discussed the changes from the current
rules and our reasons for making those
changes. Since we are largely adopting
the proposed rules as published, we are
not repeating that information here.
Interested readers may refer to the
preamble to the NPRM, available at
https://www.regulations.gov.
We are making a few changes from the
NPRM as a result of public comments.
We explain those changes in our
summary of the public comments and
our responses later in this preamble.
Why are we revising the listings for
malignant neoplastic diseases?
We developed these final rules as part
of our ongoing review of the cancer
body system. When we last revised this
body system in final rules published on
November 15, 2004,2 we indicated that
we would monitor and update the
listings in this body system as needed.
When will we use these final rules?
We will use these final rules
beginning on their effective date. We
will continue to use the current listings
until the date these final rules become
effective. We will apply the final rules
to new applications filed on or after the
effective date of the final rules and to
claims that are pending on and after the
effective date.3
2 See
69 FR 67018, corrected at 70 FR 15227.
means that we will use these final rules on
and after their effective date in any case in which
we make a determination or decision. We expect
that Federal courts will review our final decisions
using the rules that were in effect at the time we
issued the decisions. If a court reverses the
Commissioner’s final decision and remands a case
for further administrative proceedings after the
effective date of these final rules, we will apply
these final rules to the entire period at issue in the
decision we make after the court’s remand.
3 This
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How long will the rules in the
malignant neoplastic diseases body
system be in effect?
We are extending the effective date of
the malignant neoplastic diseases body
system in parts A and B of the listings
until 8 years after the effective date of
these final rules. The rules will remain
in effect only until that date unless we
extend them. We will continue to
monitor the rules and may revise them
before the end of the 8-year period.
Public Comments on the NPRM
In the NPRM, we provided the public
with a 60-day comment period, which
ended on June 27, 2008. We received
five public comment letters. The
comments came from a national cancer
advocacy group, a national group
representing disability examiners in the
State agencies that make disability
determinations for us, a national group
representing directors of those State
agencies, and two individual State
agencies.
We provide our responses below to
the significant comments that were
relevant to this rulemaking. A few of the
comments were on subjects that were
not related to the proposed rules. For
example, commenters suggested
changes to the introductory text of this
body system and some suggested that
we add new listings in sections for
which we had not proposed rules. Other
commenters made suggestions that
involved the steps of our sequential
evaluation process coming after the
listing step. Although we read and
considered these comments, we do not
summarize or respond to them below
because they are outside the scope of
this rulemaking proceeding.
We have summarized the relevant
comments below, but have tried to
present the commenters’ concerns and
suggestions accurately and completely.
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Sections 13.00I and 113.00I—What do
we mean by the following terms?
We adopted a comment that suggested
we include the term ‘‘multimodal’’ or
the phrase ‘‘multimodal therapy’’ in the
list of defined terms in sections 13.00I
and 113.00I. The commenter also
requested that we provide additional
clarification of multimodal therapy. We
adopted this comment by moving the
definition of ‘‘multimodal therapy’’
from current sections 13.00E2 and
113.00E2 to final sections 13.00I3 and
113.00I2. We also revised the
definitions in these sections to make
them clearer.
Since we added a new definition in
final sections 13.00I and 113.00I, we
renumbered the definitions that follow.
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We also changed the headings of these
sections. In the NPRM, we used the
heading ‘‘What do these terms in the
listings mean?’’ for sections 13.00I and
113.00I, and we included only terms
that were actually included in the
listings. We use the term ‘‘multimodal’’
in current listings 13.02 and 13.11, and
final listing 13.14; however, we do not
use it in any of the listings in part B.
Since we do not use the terms
‘‘multimodal’’ or ‘‘multimodal therapy’’
in any of the listings in part B, we
changed the headings in both parts.
We did not adopt a suggestion that we
include in final section 13.00I a
definition of the term ‘‘first treatment,’’
which is a term we use only when we
refer to an autologous bone marrow
transplant in current listing 13.28B. The
commenter thought that we defined this
term only in an internal instruction. In
fact, we already define ‘‘first treatment’’
in current section 13.00L3b, where we
explain how to use listing 13.28.
Moreover, listing 13.28 refers to section
13.00L3b. We think it will be easier for
our adjudicators to find the definition if
we leave it where it is.
We also did not adopt a comment that
recommended that we add a definition
for ‘‘satellite lesions.’’ We use this term
only in one section of the listing for
melanoma (a kind of skin cancer), and
we define it there. See final listing
13.03B2c.
Listing 13.02—Soft Tissue Tumors of
the Head and Neck
We did not adopt a comment
recommending that we provide general
guidance for evaluating bilateral
neuroblastomas under current listing
13.02A. We consider bilateral
neuroblastomas to be tumors of the
central nervous system, which we
evaluate under listing 13.13.
The same commenter suggested that
we emphasize in the introductory text of
the malignant neoplastic diseases body
system how to evaluate soft tumors of
the head and neck under current listing
13.02A. We did not adopt this comment
because the listing requires such tumors
to be either ‘‘inoperable’’ or
‘‘unresectable’’ and we already define
those terms in final section 13.00I.
We did, however, adopt a third
comment from this commenter
recommending that we explain how we
evaluate a recurrence that occurs more
than 3 years after remission in
connection with listing 13.02 and
another listing. In response to this
comment, we revised the second
sentence of current sections 13.00H2
and 113.00H2, which referred only to
the ‘‘original’’ tumor and any
metastases, to also include recurrences
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and relapses. We also added a sentence
at the end of final sections 13.00H3 and
113.00H3 to indicate that, if there is a
recurrence or relapse after 3 years or
another period specified in a listing in
this body system, the impairment may
again meet or medically equal the
requirements of a cancer listing. These
changes are only a clarification of our
current rules, and ensure that we will
not incorrectly find that people with
recurrent tumors are no longer disabled.
Listing 13.03—Skin
One commenter suggested that we
include criteria in listing 13.03 for
melanomas with ulcerative features. The
commenter believed that the description
of these melanomas in the current
American Joint Committee on Cancer
(AJCC) staging manual indicates listinglevel severity. We disagree with the
commenter and have not adopted the
comment. While the AJCC staging
manual does indicate that melanomas
with ulceration have a worse prognosis
than non-ulcerated melanomas, it also
indicates that many ulcerated
melanomas have good prognoses.
Therefore, we do not believe that the
AJCC staging manual describes an
impairment of listing-level severity, and
it would be inappropriate for us to find
that all people with this condition have
a listing-level impairment.
The same commenter recommended
that we add criteria for melanoma with
in-transit spread; that is, metastasis
along the lymph channels. We did not
adopt the comment because the final
listings already address the disabling
effects of in-transit spread. We will
evaluate in-transit spread that affects the
lymph nodes under final listing
13.03B2a or 13.03B2b. We will evaluate
in-transit spread that results in
metastases to adjacent skin or distant
sites under final listing 13.03B2c.
Listing 13.09—Thyroid Gland
In response to a comment, we added
final listing 113.09C, for medullary
carcinoma of the thyroid gland with
metastases beyond the regional lymph
nodes. Final listing 113.09C is identical
to final listing 13.09C. The commenter
referred to our statement in proposed
113.00K4 that we did not include a
specific listing for children because the
condition is rare in children, but did not
believe the listings are meant to exclude
cancers simply because they are rare.
Since our listings do include some rare
disorders, we agreed to add this listing
in response to the comment. We
currently find all such children with the
cancer described in final listing 113.09C
disabled based on medical equivalence
to listing 113.09B.
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In the NPRM, we explained in
proposed section 113.00K4 that we
would use listing 13.09C for children
with this type of cancer. Because we are
adding listing 113.09C, we did not
include that paragraph in these final
rules.
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Listing 13.10—Breast
One commenter recommended that
we include a listing for people with
locally advanced breast cancer who
receive multimodal therapy. The
commenter recommended that we
consider these people disabled for either
12 or 18 months from the date of
diagnosis. The commenter noted that we
have other listings that recognize the
difficulties faced by patients during
initial treatment of their cancers, even
though they have good prognoses, and
believed that we could have a similar
listing for some people with breast
cancer. The commenter indicated that
there are treatment regimens that last for
at least 7 to 12 months that may have
many side effects and that, as treatment
progresses, the side effects worsen.
We did not adopt this comment.
While we agree with the commenter that
there may be some people who are
disabled from multimodal therapy for
breast cancer and its adverse effects, we
do not believe that we can uniformly
describe those people medically, as
required for a listing. Many people who
undergo such therapy are not unable to
work for 12 continuous months.
Another commenter recommended
that we add a criterion for metastatic
breast cancer to an axillary lymph
node(s) with perforation of the capsule
(that is, tumor extension beyond the
capsule),4 with or without nodal
matting (fusion). We did not adopt this
comment because, while perforation of
the capsule, with or without matting,
increases the risk of tumor recurrence,
this finding alone does not usually
represent the level of severity intended
by the listings. We cannot have a listing
based only on a risk of recurrence
because people cannot qualify for
disability benefits before they actually
become unable to work (or for children
under title XVI, meet the definition of
disability for children). When there is
recurrence, we will evaluate it under
listing 13.10C.
Listing 13.13—Nervous System
One commenter recommended that
we rewrite listing 13.13 to separate
neoplasms that require metastases from
those that do not. The commenter
provided a suggested revision, but we
4 The capsule is a membrane of fibrous tissue that
encases the lymph node.
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did not adopt it for two reasons. First,
the revisions we proposed to the listing
did separate the neoplasms that require
metastases from those that do not. As
we explained in the preamble to the
NPRM:
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
want[ ] to make the current sentence
structure clearer. Therefore, we propose to
reorganize the sentence for clarity.5
Second, and more importantly, the
language the commenter proposed could
have been misinterpreted to include
under this listing medulloblastomas and
other PNETs that have not metastasized.
This interpretation would have been
contrary to our intent, as we explained
when we last made comprehensive
revisions to the malignant neoplastic
diseases body system in 2004.6 In that
final rule, we explained that we could
evaluate medulloblastomas or other
PNETs that have not metastasized under
listing 13.13A2.
Listing 13.23—Cancers of the Female
Genital Tract
One commenter pointed out that we
have no listing for cancer of the vagina,
nor do we provide guidance in the
introductory text on how adjudicators
should evaluate this malignancy. The
commenter suggested that we revise
listing 13.23C to include cancer of the
vagina or that we explain which listing
to use to evaluate this condition. We
adopted this comment by including
cancer of the vagina in listing 13.23C.
The criteria for listing-level cancer of
the vulva are also appropriate for cancer
of the vagina. Under the prior rules, we
would have found medical equivalence
to this listing in such cases.
Two commenters expressed concern
about our proposal to remove prior
listing 13.23E1c, for ovarian cancer with
ruptured ovarian capsule, tumor on the
serosal surface, ascites with malignant
cells, or positive peritoneal washings.
One comment letter said that the
medical literature with which the
commenters were familiar showed that
ovarian cancer with these findings has
a high mortality rate. However, in the
NPRM we cited current medical
literature indicating that therapy has
significantly improved the prognosis for
5 See
6 See
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69 FR at 67024.
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51231
women who have ovarian cancer with
these findings.7 Based on this medical
literature, we believe that most women
who have ovarian cancer with the
findings in prior listing 13.23E1c have
a good prognosis.
The other commenter, a national
advocacy group for women with ovarian
cancer, agreed with us that the
prognosis for these cases has improved
significantly, but recommended that we
keep the listing to recognize the length
and side effects of treatment. The
commenter pointed out that women
with these findings may undergo the
same or similar surgery and
chemotherapy as women with more
advanced disease and that this
treatment substantially limits those
women’s ability for gainful activity.
While we appreciate the second
commenter’s concerns—and we agree
that some women with the findings in
the prior listing will be disabled—we
did not adopt the recommendation to
keep the listing, primarily because many
women with the findings in prior listing
13.23E1c will not be unable to work for
at least 12 months. Even though they
may be debilitated while they undergo
treatment and for some time afterward,
many of these women will have only
minimal functional limitations 12
months after diagnosis. Therefore, it
would be inappropriate for us to keep
the prior listing, which would require
us to find that all women with the listed
criteria are disabled. We must evaluate
these cases on an individual basis.
Finally, two commenters
recommended that we not remove the
listing 13.23E1c because there may be a
recurrence of the disease, and a
recurrence generally has a poor
prognosis. We agree that recurrent
ovarian cancer has a poor prognosis, but
we already include it in final listing
13.23E1c, our criterion for recurrent
ovarian cancer. As we have already
noted, we cannot have a listing based
only on a risk of recurrence.
Listing 13.24—Prostate Gland
We did not adopt a suggestion that we
clarify in the introductory text how our
adjudicators should use the Gleason
grading scale 8 in connection with
listing 13.24 because the listing criteria
are not based on this scale. The listing
requires that the tumor not respond to
initial hormonal treatment or that it
metastasize to internal organs. The
7 For the list of references we consulted, see 73
FR at 22875.
8 The Gleason grades and scores are used to help
evaluate the prognosis of men with prostate cancer.
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Gleason grade does not indicate whether
the tumor meets these criteria.
title 20 of the Code of Federal
Regulations as set forth below:
Other Changes From the NPRM
We made a number of editorial
corrections and changes in the final
rules from the language of the NPRM.
For example, we changed some
sentences from passive into active voice.
These changes are only for clarity,
consistency, and to correct minor
grammatical errors in the NPRM; none
are substantive.
PART 404—FEDERAL OLD-AGE,
SURVIVORS AND DISABILITY
INSURANCE (1950– )
What is our authority to make rules
and set procedures for determining
whether a person is disabled under the
statutory definition?
Under the Act, we have full power
and authority to make rules and
regulations and to establish necessary
and appropriate procedures to carry out
such provisions. Sections 205(a),
702(a)(5), and 1631(d)(1).
Regulatory Procedures
Executive Order 12866
We have consulted with the Office of
Management and Budget (OMB) and
determined that these final rules meet
the requirements for a significant
regulatory action under Executive Order
12866 and were subject to OMB review.
Regulatory Flexibility Act
We certify that these final rules have
no significant economic impact on a
substantial number of small entities
because they affect only individuals.
Therefore, a regulatory flexibility
analysis was not required under the
Regulatory Flexibility Act, as amended.
Paperwork Reduction Act
This rule does not create any new or
affect any existing collections and,
therefore, does not require Office of
Management and Budget approval
under the Paperwork Reduction Act.
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(Catalog of Federal Domestic Assistance
Program Nos. 96.001, Social Security—
Disability Insurance; 96.002, Social
Security—Retirement Insurance; 96.004,
Social Security—Survivors Insurance; and
96.006, Supplemental Security Income)
List of Subjects in 20 CFR Part 404
Administrative practice and
procedure, Blind, Disability benefits,
Old-Age, Survivors and Disability
Insurance, Reporting and recordkeeping
requirements, Social Security.
Dated: July 30, 2009.
Michael J. Astrue,
Commissioner of Social Security.
For the reasons set out in the
preamble, we amend appendix 1 to
subpart P of part 404 of chapter III of
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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. Amend appendix 1 to subpart P of
Part 404 as follows:
■ a. Revise item 14 of the introductory
text before part A of appendix 1.
■ b. Revise paragraph E2 of section
13.00 of part A of appendix 1.
■ c. Revise the second sentence of
paragraph H2 and add a new second
sentence to paragraph H3 of section
13.00 of part A of appendix 1.
■ d. Revise paragraph I of section 13.00
of part A of appendix 1.
■ e. Amend paragraph K of section
13.00 of part A of appendix 1 by
revising K1a, K1b, the third sentence of
K2a, and K6.
■ f. Revise listing 13.02C of part A of
appendix 1.
■ g. Revise listing 13.03B2 of part A of
appendix 1.
■ h. Amend listing 13.05 of part A of
appendix 1 by revising the listing
13.05A.
■ i. Amend listing 13.09 of part A of
appendix 1 by adding the word ‘‘OR’’
after listing 13.09B and adding listing
13.09C.
■ j. Revise listing 13.10B of part A of
appendix 1.
■ k. Revise the heading of listing 13.11
of part A of appendix 1.
■ l. Revise listing 13.13A of part A of
appendix 1.
■ m. Amend listing 13.14 of part A of
appendix 1 by adding the word ‘‘OR’’
after listing 13.14B and adding listing
13.14C.
■ n. Revise listings 13.23C and 13.23E1
of part A of appendix 1.
■ o. Revise listing 13.24B of part A of
appendix 1.
■ p. Revise listing 13.27 of part A of
appendix 1.
■ q. Revise paragraph E2 of section
113.00 of part B of appendix 1.
■ r. Revise the second sentence of
paragraph H2 and add a new second
sentence to paragraph H3 of section
113.00 of part B of appendix 1.
■ s. Revise paragraph I of section 113.00
of part B of appendix 1.
■ t. Amend paragraph K of section
113.00 of part B of appendix 1 by
■
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revising K1a, the third sentence of K2a,
and K4.
■ u. Amend listing 113.09 of part B of
appendix 1 by adding the word ‘‘OR’’
after listing 113.09B and adding listing
113.09C.
■ v. 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
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14. Malignant Neoplastic Diseases (13.00
and 113.00): November 5, 2017
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Part A
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13.00 MALIGNANT NEOPLASTIC
DISEASES
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E. When do we need longitudinal evidence?
*
*
*
*
*
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; that is,
multimodal therapy (see 13.00I3).
*
*
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*
H. How long do we consider your
impairment to be disabling?
*
*
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*
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2. * * * When the impairment(s) has been
in complete remission for at least 3 years,
that is, the original tumor or a recurrence (or
relapse) and any metastases have not been
evident for at least 3 years, the impairment(s)
will no longer meet or medically equal the
criteria of a listing in this body system.
3. * * * If you have a recurrence or relapse
of your malignancy, your impairment may
meet or medically equal one of the listings
in this body system again.
*
*
*
*
*
I. What do we mean by the following
terms?
1. Inoperable: Surgery is thought to be of
no therapeutic value or the surgery cannot be
performed; for example, when you cannot
tolerate anesthesia or surgery because of
another impairment(s), or you have a tumor
that is too large or that has invaded crucial
structures. This term does not include
situations in which your tumor could have
been surgically removed but another method
of treatment was chosen; for example, an
attempt at organ preservation. Your
physician may determine whether a tumor is
inoperable before or after you receive
neoadjuvant therapy. Neoadjuvant therapy is
antineoplastic therapy, such as
chemotherapy or radiation, given before
surgery in order to reduce the size of the
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 tissues
or organs.
E:\FR\FM\06OCR1.SGM
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Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Rules and Regulations
3. Multimodal therapy: A combination of at
least two types of treatment modalities given
in close proximity as a unified whole and
usually planned before any treatment has
begun. There are three types of treatment
modalities: Surgery, radiation, and systemic
drug therapy (chemotherapy, hormonal
therapy, and immunotherapy).
Examples of multimodal therapy include:
a. Surgery followed by chemotherapy or
radiation.
b. Chemotherapy followed by surgery.
c. Chemotherapy and concurrent radiation.
4. Persistent: Failure to achieve a complete
remission.
5. Progressive: The malignancy becomes
more extensive after treatment.
6. Recurrent, relapse: A malignancy that
was in complete remission or entirely
removed by surgery has returned.
7. Unresectable: Surgery was performed,
but the malignant tumor was not removed.
This term includes situations in which your
tumor is incompletely resected or the
surgical margins are positive. It does not
include situations in which a tumor is
completely resected but you are receiving
adjuvant therapy. Adjuvant therapy is
antineoplastic therapy, such as
chemotherapy or radiation, given after
surgery in order to eliminate any remaining
cancer cells 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 the
lymphomas may produce intermittent
symptoms and signs. Therefore, we may
defer adjudicating these cases for an
appropriate period after therapy is initiated
to determine whether the therapy will
achieve its intended effect, which is usually
to stabilize the disease process. (See
13.00E3.) When your disease has been
stabilized, we will assess severity based on
the extent of involvement of other organ
systems and residuals from therapy.
b. A change in therapy for indolent
lymphomas is usually an indicator that the
therapy is not achieving its intended effect.
However, your impairment will not meet the
requirements of 13.05A2 if your therapy is
changed solely because you or your
physician choose to change it, not because of
a failure to achieve stability.
*
*
*
*
*
CPrice-Sewell on DSKGBLS3C1PROD with RULES
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 (WHO)
classification of tumors of the central nervous
system (WHO Classification of Tumours of
the Central Nervous System, 2007). We
evaluate any complications of malignant
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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.
*
*
*
*
*
13.02 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.
*
*
*
*
*
2. Progressive or recurrent following initial
antineoplastic therapy.
OR
*
*
*
2. With metastases as described in a, b, or
*
*
*
13.14 Lungs.
B. * * *
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.
*
B. Melanoma, as described in 1 or 2.
51233
*
*
*
*
13.23 Cancers of the female genital
tract—carcinoma or sarcoma.
*
*
*
*
*
C. Vulva or vagina, as described in 1, 2, 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. Metastases to adjacent skin (satellite
lesions) or distant sites.
3:
1. Invading adjoining organs.
2. With metastases to or beyond the
regional lymph nodes.
3. Persistent or recurrent following initial
antineoplastic therapy.
*
*
*
*
*
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.
B. * * *
OR
C. Medullary carcinoma with metastases
beyond the regional lymph nodes.
13.10 Breast (except sarcoma—13.04).
(See 13.00K4.)
*
*
*
*
*
13.11
*
*
*
*
*
*
*
13.13 Nervous system. (See 13.00K6.)
A. Central nervous system malignant
neoplasms (brain and spinal cord), as
described in 1 or 2:
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.
PO 00000
Frm 00005
Fmt 4700
Sfmt 4700
*
*
*
*
*
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
*
*
*
*
*
E. When do we need longitudinal evidence?
Skeletal system—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.
*
B. Carcinoma with metastases to the
supraclavicular or infraclavicular nodes, to
10 or more axillary nodes, or with distant
metastases.
*
*
*
*
*
*
*
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; that is,
multimodal therapy (see 113.00I2).
*
*
*
*
*
H. How long do we consider your
impairment to be disabling?
*
*
*
*
*
2. * * * When the impairment(s) has been
in complete remission for at least 3 years,
that is, the original tumor or a recurrence (or
relapse) and any metastases have not been
evident for at least 3 years, the impairment(s)
E:\FR\FM\06OCR1.SGM
06OCR1
51234
Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Rules and Regulations
will no longer meet or medically equal the
criteria of a listing in this body system.
3. * * * If you have a recurrence or relapse
of your malignancy, your impairment may
meet or medically equal one of the listings
in this body system again.
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.
*
*
*
*
*
*
I. What do we mean by the following
terms?
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. Multimodal therapy: A combination of at
least two types of treatment modalities given
in close proximity as a unified whole and
usually planned before any treatment has
begun. There are three types of treatment
modalities: Surgery, radiation, and systemic
drug therapy (chemotherapy, hormonal
therapy, and immunotherapy). Examples of
multimodal therapy include:
a. Surgery followed by chemotherapy or
radiation.
b. Chemotherapy followed by surgery.
c. Chemotherapy and concurrent radiation.
3. Persistent: Failure to achieve a complete
remission.
4. Progressive: The malignancy becomes
more extensive despite treatment.
5. Recurrent, relapse: A malignancy that
was 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 (non-aggressive) 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. * * *
*
*
*
*
*
CPrice-Sewell on DSKGBLS3C1PROD with RULES
4. 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 (WHO)
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.
*
*
*
*
*
113.09 Thyroid gland.
B. * * *
OR
C. Medullary carcinoma with metastases
beyond the regional lymph nodes.
*
*
*
*
*
113.13 Brain tumors. (See 113.00K4.)
Highly malignant tumors, such as
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13:16 Oct 05, 2009
Jkt 220001
*
*
*
*
[FR Doc. E9–23896 Filed 10–5–09; 8:45 am]
BILLING CODE 4191–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–327F]
Schedules of Controlled Substances;
Placement of Fospropofol Into
Schedule IV
AGENCY: Drug Enforcement
Administration, Department of Justice.
ACTION: Final rule.
SUMMARY: With the issuance of this final
rule, the Deputy Administrator of the
Drug Enforcement Administration
(DEA) places the substance fospropofol,
including its salts, isomers and salts of
isomers whenever the existence of such
salts, isomers, and salts of isomers is
possible, into schedule IV of the
Controlled Substances Act (CSA). As a
result of this rule, the regulatory
controls and criminal sanctions of
schedule IV will be applicable to the
manufacture, distribution, dispensing,
importation, and exportation of
fospropofol and products containing
fospropofol.
DATES:
Effective Date: November 5,
2009.
FOR FURTHER INFORMATION CONTACT:
Christine A. Sannerud, PhD, Chief, Drug
and Chemical Evaluation Section, Office
of Diversion Control, Drug Enforcement
Administration, 8701 Morrissette Drive,
Springfield, Virginia 22152, Telephone:
(202) 307–7183.
SUPPLEMENTARY INFORMATION:
Background
On December 12, 2008, the Food and
Drug Administration (FDA) approved
fospropofol for marketing under the
trade name Lusedra® in the United
States as a drug product indicated for
monitored anesthesia care (MAC)
sedation in adult patients undergoing
diagnostic or therapeutic procedures.
Fospropofol, 2,6diisopropopylphenoxymethyl
phosphate disodium, is a water soluble,
phosphono-O-methyl prodrug of
propofol. It is metabolized in the body
to propofol, the active metabolite.
PO 00000
Frm 00006
Fmt 4700
Sfmt 4700
Propofol has been available for medical
use in the United States since 1989 and
is not currently a controlled substance.
The pharmacological effects of
fospropofol are attributed to the
pharmacological actions of propofol.
Propofol binds to g-aminobutyric acid
(GABAA) receptor and acts as a
modulator by potentiating the activity of
GABA at this receptor.
Since propofol is the active metabolite
of fospropofol, the abuse potential of
fospropofol is comparable to that of
propofol. Animal self-administration
studies demonstrated that the
reinforcing effects of propofol are
relatively low and comparable to
midazolam and other schedule IV
benzodiazepines. Fospropofol elicits
behavioral effects similar to
methohexital and midazolam, schedule
IV sedative-hypnotics.
Since fospropofol is a new molecular
entity, there has been no evidence of
diversion, abuse, or law enforcement
encounters involving the drug.
On February 27, 2009, the Acting
Assistant Secretary for Health,
Department of Health and Human
Services (DHHS), sent the Deputy
Administrator of DEA a scientific and
medical evaluation and a letter
recommending that fospropofol be
placed into schedule IV of the CSA.
Enclosed with the February 27, 2009,
letter was a document prepared by the
FDA entitled, ‘‘Basis for the
Recommendation for Control of
Fospropofol and Its Salts in Schedule IV
of the Controlled Substances Act
(CSA).’’ The document contained a
review of the factors which the CSA
requires the Secretary to consider
(21 U.S.C. 811(b)).
After a review of the available data,
including the scientific and medical
evaluation and the scheduling
recommendation from DHHS, the
Deputy Administrator of the DEA
published a Notice of Proposed
Rulemaking entitled ‘‘Schedules of
Controlled Substances: Placement of
Fospropofol into Schedule IV’’ on July
23, 2009 (74 FR 36424), which proposed
placement of fospropofol into schedule
IV of the CSA. The proposed rule
provided an opportunity for all
interested persons to submit their
written comments on or before August
24, 2009.
Comments Received
The DEA received two comments in
response to the Notice of Proposed
Rulemaking. One comment received
from a concerned citizen did not relate
to fospropofol, the substance that is
being controlled. Thus DEA did not
consider this comment.
E:\FR\FM\06OCR1.SGM
06OCR1
]]>Agencies
[Federal Register Volume 74, Number 192 (Tuesday, October 6, 2009)]
[Rules and Regulations]
[Pages 51229-51234]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23896]
=======================================================================
-----------------------------------------------------------------------
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: Final rule.
-----------------------------------------------------------------------
SUMMARY: We are revising some of the criteria in the Listing of
Impairments (the listings) that we use to evaluate claims involving
malignant neoplastic diseases (cancer) \1\ under titles II and XVI of
the Social Security Act (Act). The revisions reflect our adjudicative
experience, advances in medical knowledge, diagnosis, and treatment,
and public comments we received in response to a Notice of Proposed
Rulemaking (NPRM).
---------------------------------------------------------------------------
\1\ ``Malignant neoplastic disease'' is commonly known as
``cancer.'' We use both terms interchangeably in this document
because we continue to use the technical medical term in the
listings.
---------------------------------------------------------------------------
DATES: This rule is effective November 5, 2009.
FOR FURTHER INFORMATION CONTACT: Mark Kuhn, Office of Medical Listings
Improvement, Social Security Administration, 6401 Security Boulevard,
Baltimore, Maryland 21235-6401, (410) 965-1020. For information on
eligibility or filing for benefits, call our national toll-free number,
1-800-772-1213, or TTY 1-800-325-0778, or visit our Internet 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/.
Background
We are revising and making final the rules for evaluating malignant
neoplastic diseases we proposed in an NPRM published in the Federal
Register on April 24, 2008 (73 FR 22871). The preamble to the NPRM
discussed the changes from the current rules and our reasons for making
those changes. Since we are largely adopting the proposed rules as
published, we are not repeating that information here. Interested
readers may refer to the preamble to the NPRM, available at https://www.regulations.gov.
We are making a few changes from the NPRM as a result of public
comments. We explain those changes in our summary of the public
comments and our responses later in this preamble.
Why are we revising the listings for malignant neoplastic diseases?
We developed these final rules as part of our ongoing review of the
cancer body system. When we last revised this body system in final
rules published on November 15, 2004,\2\ we indicated that we would
monitor and update the listings in this body system as needed.
---------------------------------------------------------------------------
\2\ See 69 FR 67018, corrected at 70 FR 15227.
---------------------------------------------------------------------------
When will we use these final rules?
We will use these final rules beginning on their effective date. We
will continue to use the current listings until the date these final
rules become effective. We will apply the final rules to new
applications filed on or after the effective date of the final rules
and to claims that are pending on and after the effective date.\3\
---------------------------------------------------------------------------
\3\ This means that we will use these final rules on and after
their effective date in any case in which we make a determination or
decision. We expect that Federal courts will review our final
decisions using the rules that were in effect at the time we issued
the decisions. If a court reverses the Commissioner's final decision
and remands a case for further administrative proceedings after the
effective date of these final rules, we will apply these final rules
to the entire period at issue in the decision we make after the
court's remand.
---------------------------------------------------------------------------
[[Page 51230]]
How long will the rules in the malignant neoplastic diseases body
system be in effect?
We are extending the effective date of the malignant neoplastic
diseases body system in parts A and B of the listings until 8 years
after the effective date of these final rules. The rules will remain in
effect only until that date unless we extend them. We will continue to
monitor the rules and may revise them before the end of the 8-year
period.
Public Comments on the NPRM
In the NPRM, we provided the public with a 60-day comment period,
which ended on June 27, 2008. We received five public comment letters.
The comments came from a national cancer advocacy group, a national
group representing disability examiners in the State agencies that make
disability determinations for us, a national group representing
directors of those State agencies, and two individual State agencies.
We provide our responses below to the significant comments that
were relevant to this rulemaking. A few of the comments were on
subjects that were not related to the proposed rules. For example,
commenters suggested changes to the introductory text of this body
system and some suggested that we add new listings in sections for
which we had not proposed rules. Other commenters made suggestions that
involved the steps of our sequential evaluation process coming after
the listing step. Although we read and considered these comments, we do
not summarize or respond to them below because they are outside the
scope of this rulemaking proceeding.
We have summarized the relevant comments below, but have tried to
present the commenters' concerns and suggestions accurately and
completely.
Sections 13.00I and 113.00I--What do we mean by the following terms?
We adopted a comment that suggested we include the term
``multimodal'' or the phrase ``multimodal therapy'' in the list of
defined terms in sections 13.00I and 113.00I. The commenter also
requested that we provide additional clarification of multimodal
therapy. We adopted this comment by moving the definition of
``multimodal therapy'' from current sections 13.00E2 and 113.00E2 to
final sections 13.00I3 and 113.00I2. We also revised the definitions in
these sections to make them clearer.
Since we added a new definition in final sections 13.00I and
113.00I, we renumbered the definitions that follow. We also changed the
headings of these sections. In the NPRM, we used the heading ``What do
these terms in the listings mean?'' for sections 13.00I and 113.00I,
and we included only terms that were actually included in the listings.
We use the term ``multimodal'' in current listings 13.02 and 13.11, and
final listing 13.14; however, we do not use it in any of the listings
in part B. Since we do not use the terms ``multimodal'' or ``multimodal
therapy'' in any of the listings in part B, we changed the headings in
both parts.
We did not adopt a suggestion that we include in final section
13.00I a definition of the term ``first treatment,'' which is a term we
use only when we refer to an autologous bone marrow transplant in
current listing 13.28B. The commenter thought that we defined this term
only in an internal instruction. In fact, we already define ``first
treatment'' in current section 13.00L3b, where we explain how to use
listing 13.28. Moreover, listing 13.28 refers to section 13.00L3b. We
think it will be easier for our adjudicators to find the definition if
we leave it where it is.
We also did not adopt a comment that recommended that we add a
definition for ``satellite lesions.'' We use this term only in one
section of the listing for melanoma (a kind of skin cancer), and we
define it there. See final listing 13.03B2c.
Listing 13.02--Soft Tissue Tumors of the Head and Neck
We did not adopt a comment recommending that we provide general
guidance for evaluating bilateral neuroblastomas under current listing
13.02A. We consider bilateral neuroblastomas to be tumors of the
central nervous system, which we evaluate under listing 13.13.
The same commenter suggested that we emphasize in the introductory
text of the malignant neoplastic diseases body system how to evaluate
soft tumors of the head and neck under current listing 13.02A. We did
not adopt this comment because the listing requires such tumors to be
either ``inoperable'' or ``unresectable'' and we already define those
terms in final section 13.00I.
We did, however, adopt a third comment from this commenter
recommending that we explain how we evaluate a recurrence that occurs
more than 3 years after remission in connection with listing 13.02 and
another listing. In response to this comment, we revised the second
sentence of current sections 13.00H2 and 113.00H2, which referred only
to the ``original'' tumor and any metastases, to also include
recurrences and relapses. We also added a sentence at the end of final
sections 13.00H3 and 113.00H3 to indicate that, if there is a
recurrence or relapse after 3 years or another period specified in a
listing in this body system, the impairment may again meet or medically
equal the requirements of a cancer listing. These changes are only a
clarification of our current rules, and ensure that we will not
incorrectly find that people with recurrent tumors are no longer
disabled.
Listing 13.03--Skin
One commenter suggested that we include criteria in listing 13.03
for melanomas with ulcerative features. The commenter believed that the
description of these melanomas in the current American Joint Committee
on Cancer (AJCC) staging manual indicates listing-level severity. We
disagree with the commenter and have not adopted the comment. While the
AJCC staging manual does indicate that melanomas with ulceration have a
worse prognosis than non-ulcerated melanomas, it also indicates that
many ulcerated melanomas have good prognoses. Therefore, we do not
believe that the AJCC staging manual describes an impairment of
listing-level severity, and it would be inappropriate for us to find
that all people with this condition have a listing-level impairment.
The same commenter recommended that we add criteria for melanoma
with in-transit spread; that is, metastasis along the lymph channels.
We did not adopt the comment because the final listings already address
the disabling effects of in-transit spread. We will evaluate in-transit
spread that affects the lymph nodes under final listing 13.03B2a or
13.03B2b. We will evaluate in-transit spread that results in metastases
to adjacent skin or distant sites under final listing 13.03B2c.
Listing 13.09--Thyroid Gland
In response to a comment, we added final listing 113.09C, for
medullary carcinoma of the thyroid gland with metastases beyond the
regional lymph nodes. Final listing 113.09C is identical to final
listing 13.09C. The commenter referred to our statement in proposed
113.00K4 that we did not include a specific listing for children
because the condition is rare in children, but did not believe the
listings are meant to exclude cancers simply because they are rare.
Since our listings do include some rare disorders, we agreed to add
this listing in response to the comment. We currently find all such
children with the cancer described in final listing 113.09C disabled
based on medical equivalence to listing 113.09B.
[[Page 51231]]
In the NPRM, we explained in proposed section 113.00K4 that we
would use listing 13.09C for children with this type of cancer. Because
we are adding listing 113.09C, we did not include that paragraph in
these final rules.
Listing 13.10--Breast
One commenter recommended that we include a listing for people with
locally advanced breast cancer who receive multimodal therapy. The
commenter recommended that we consider these people disabled for either
12 or 18 months from the date of diagnosis. The commenter noted that we
have other listings that recognize the difficulties faced by patients
during initial treatment of their cancers, even though they have good
prognoses, and believed that we could have a similar listing for some
people with breast cancer. The commenter indicated that there are
treatment regimens that last for at least 7 to 12 months that may have
many side effects and that, as treatment progresses, the side effects
worsen.
We did not adopt this comment. While we agree with the commenter
that there may be some people who are disabled from multimodal therapy
for breast cancer and its adverse effects, we do not believe that we
can uniformly describe those people medically, as required for a
listing. Many people who undergo such therapy are not unable to work
for 12 continuous months.
Another commenter recommended that we add a criterion for
metastatic breast cancer to an axillary lymph node(s) with perforation
of the capsule (that is, tumor extension beyond the capsule),\4\ with
or without nodal matting (fusion). We did not adopt this comment
because, while perforation of the capsule, with or without matting,
increases the risk of tumor recurrence, this finding alone does not
usually represent the level of severity intended by the listings. We
cannot have a listing based only on a risk of recurrence because people
cannot qualify for disability benefits before they actually become
unable to work (or for children under title XVI, meet the definition of
disability for children). When there is recurrence, we will evaluate it
under listing 13.10C.
---------------------------------------------------------------------------
\4\ The capsule is a membrane of fibrous tissue that encases the
lymph node.
---------------------------------------------------------------------------
Listing 13.13--Nervous System
One commenter recommended that we rewrite listing 13.13 to separate
neoplasms that require metastases from those that do not. The commenter
provided a suggested revision, but we did not adopt it for two reasons.
First, the revisions we proposed to the listing did separate the
neoplasms that require metastases from those that do not. As we
explained in the preamble to the NPRM:
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 want[ ] to make the current sentence structure
clearer. Therefore, we propose to reorganize the sentence for
clarity.\5\
---------------------------------------------------------------------------
\5\ See 73 FR at 22873.
Second, and more importantly, the language the commenter proposed could
have been misinterpreted to include under this listing medulloblastomas
and other PNETs that have not metastasized. This interpretation would
have been contrary to our intent, as we explained when we last made
comprehensive revisions to the malignant neoplastic diseases body
system in 2004.\6\ In that final rule, we explained that we could
evaluate medulloblastomas or other PNETs that have not metastasized
under listing 13.13A2.
---------------------------------------------------------------------------
\6\ See 69 FR at 67024.
---------------------------------------------------------------------------
Listing 13.23--Cancers of the Female Genital Tract
One commenter pointed out that we have no listing for cancer of the
vagina, nor do we provide guidance in the introductory text on how
adjudicators should evaluate this malignancy. The commenter suggested
that we revise listing 13.23C to include cancer of the vagina or that
we explain which listing to use to evaluate this condition. We adopted
this comment by including cancer of the vagina in listing 13.23C. The
criteria for listing-level cancer of the vulva are also appropriate for
cancer of the vagina. Under the prior rules, we would have found
medical equivalence to this listing in such cases.
Two commenters expressed concern about our proposal to remove prior
listing 13.23E1c, for ovarian cancer with ruptured ovarian capsule,
tumor on the serosal surface, ascites with malignant cells, or positive
peritoneal washings. One comment letter said that the medical
literature with which the commenters were familiar showed that ovarian
cancer with these findings has a high mortality rate. However, in the
NPRM we cited current medical literature indicating that therapy has
significantly improved the prognosis for women who have ovarian cancer
with these findings.\7\ Based on this medical literature, we believe
that most women who have ovarian cancer with the findings in prior
listing 13.23E1c have a good prognosis.
---------------------------------------------------------------------------
\7\ For the list of references we consulted, see 73 FR at 22875.
---------------------------------------------------------------------------
The other commenter, a national advocacy group for women with
ovarian cancer, agreed with us that the prognosis for these cases has
improved significantly, but recommended that we keep the listing to
recognize the length and side effects of treatment. The commenter
pointed out that women with these findings may undergo the same or
similar surgery and chemotherapy as women with more advanced disease
and that this treatment substantially limits those women's ability for
gainful activity.
While we appreciate the second commenter's concerns--and we agree
that some women with the findings in the prior listing will be
disabled--we did not adopt the recommendation to keep the listing,
primarily because many women with the findings in prior listing
13.23E1c will not be unable to work for at least 12 months. Even though
they may be debilitated while they undergo treatment and for some time
afterward, many of these women will have only minimal functional
limitations 12 months after diagnosis. Therefore, it would be
inappropriate for us to keep the prior listing, which would require us
to find that all women with the listed criteria are disabled. We must
evaluate these cases on an individual basis.
Finally, two commenters recommended that we not remove the listing
13.23E1c because there may be a recurrence of the disease, and a
recurrence generally has a poor prognosis. We agree that recurrent
ovarian cancer has a poor prognosis, but we already include it in final
listing 13.23E1c, our criterion for recurrent ovarian cancer. As we
have already noted, we cannot have a listing based only on a risk of
recurrence.
Listing 13.24--Prostate Gland
We did not adopt a suggestion that we clarify in the introductory
text how our adjudicators should use the Gleason grading scale \8\ in
connection with listing 13.24 because the listing criteria are not
based on this scale. The listing requires that the tumor not respond to
initial hormonal treatment or that it metastasize to internal organs.
The
[[Page 51232]]
Gleason grade does not indicate whether the tumor meets these criteria.
---------------------------------------------------------------------------
\8\ The Gleason grades and scores are used to help evaluate the
prognosis of men with prostate cancer.
---------------------------------------------------------------------------
Other Changes From the NPRM
We made a number of editorial corrections and changes in the final
rules from the language of the NPRM. For example, we changed some
sentences from passive into active voice. These changes are only for
clarity, consistency, and to correct minor grammatical errors in the
NPRM; none are substantive.
What is our authority to make rules and set procedures for determining
whether a person is disabled under the statutory definition?
Under the Act, we have full power and authority to make rules and
regulations and to establish necessary and appropriate procedures to
carry out such provisions. Sections 205(a), 702(a)(5), and 1631(d)(1).
Regulatory Procedures
Executive Order 12866
We have consulted with the Office of Management and Budget (OMB)
and determined that these final rules meet the requirements for a
significant regulatory action under Executive Order 12866 and were
subject to OMB review.
Regulatory Flexibility Act
We certify that these final rules have no significant economic
impact on a substantial number of small entities because they affect
only individuals. Therefore, a regulatory flexibility analysis was not
required under the Regulatory Flexibility Act, as amended.
Paperwork Reduction Act
This rule does not create any new or affect any existing
collections and, therefore, does not require Office of Management and
Budget approval under the Paperwork Reduction Act.
(Catalog of Federal Domestic Assistance Program Nos. 96.001, Social
Security--Disability Insurance; 96.002, Social Security--Retirement
Insurance; 96.004, Social Security--Survivors Insurance; and 96.006,
Supplemental Security Income)
List of Subjects in 20 CFR Part 404
Administrative practice and procedure, Blind, Disability benefits,
Old-Age, Survivors and Disability Insurance, Reporting and
recordkeeping requirements, Social Security.
Dated: July 30, 2009.
Michael J. Astrue,
Commissioner of Social Security.
0
For the reasons set out in the preamble, we 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- )
0
1. The authority citation for subpart P of part 404 continues to read
as follows:
Authority: Secs. 202, 205(a), (b), and (d)-(h), 216(i), 221(a)
and (i), 222(c), 223, 225, and 702(a)(5) of the Social Security Act
(42 U.S.C. 402, 405(a), (b), and (d)-(h), 416(i), 421(a) and (i),
422(c), 423, 425, and 902(a)(5)); sec. 211(b), Pub. L. 104-193, 110
Stat. 2105, 2189; sec. 202, Pub. L. 108-203, 118 Stat. 509 (42
U.S.C. 902 note).
0
2. Amend appendix 1 to subpart P of Part 404 as follows:
0
a. Revise item 14 of the introductory text before part A of appendix 1.
0
b. Revise paragraph E2 of section 13.00 of part A of appendix 1.
0
c. Revise the second sentence of paragraph H2 and add a new second
sentence to paragraph H3 of section 13.00 of part A of appendix 1.
0
d. Revise paragraph I of section 13.00 of part A of appendix 1.
0
e. Amend paragraph K of section 13.00 of part A of appendix 1 by
revising K1a, K1b, the third sentence of K2a, and K6.
0
f. Revise listing 13.02C of part A of appendix 1.
0
g. Revise listing 13.03B2 of part A of appendix 1.
0
h. Amend listing 13.05 of part A of appendix 1 by revising the listing
13.05A.
0
i. Amend listing 13.09 of part A of appendix 1 by adding the word
``OR'' after listing 13.09B and adding listing 13.09C.
0
j. Revise listing 13.10B of part A of appendix 1.
0
k. Revise the heading of listing 13.11 of part A of appendix 1.
0
l. Revise listing 13.13A of part A of appendix 1.
0
m. Amend listing 13.14 of part A of appendix 1 by adding the word
``OR'' after listing 13.14B and adding listing 13.14C.
0
n. Revise listings 13.23C and 13.23E1 of part A of appendix 1.
0
o. Revise listing 13.24B of part A of appendix 1.
0
p. Revise listing 13.27 of part A of appendix 1.
0
q. Revise paragraph E2 of section 113.00 of part B of appendix 1.
0
r. Revise the second sentence of paragraph H2 and add a new second
sentence to paragraph H3 of section 113.00 of part B of appendix 1.
0
s. Revise paragraph I of section 113.00 of part B of appendix 1.
0
t. Amend paragraph K of section 113.00 of part B of appendix 1 by
revising K1a, the third sentence of K2a, and K4.
0
u. Amend listing 113.09 of part B of appendix 1 by adding the word
``OR'' after listing 113.09B and adding listing 113.09C.
0
v. 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): November
5, 2017
* * * * *
Part A
* * * * *
13.00 MALIGNANT NEOPLASTIC DISEASES
* * * * *
E. When do we need longitudinal evidence?
* * * * *
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; that is, multimodal therapy (see
13.00I3).
* * * * *
H. How long do we consider your impairment to be disabling?
* * * * *
2. * * * When the impairment(s) has been in complete remission
for at least 3 years, that is, the original tumor or a recurrence
(or relapse) and any metastases have not been evident for at least 3
years, the impairment(s) will no longer meet or medically equal the
criteria of a listing in this body system.
3. * * * If you have a recurrence or relapse of your malignancy,
your impairment may meet or medically equal one of the listings in
this body system again.
* * * * *
I. What do we mean by the following terms?
1. Inoperable: Surgery is thought to be of no therapeutic value
or the surgery cannot be performed; for example, when you cannot
tolerate anesthesia or surgery because of another impairment(s), or
you have a tumor that is too large or that has invaded crucial
structures. This term does not include situations in which your
tumor could have been surgically removed but another method of
treatment was chosen; for example, an attempt at organ preservation.
Your physician may determine whether a tumor is inoperable before or
after you receive neoadjuvant therapy. Neoadjuvant therapy is
antineoplastic therapy, such as chemotherapy or radiation, given
before surgery in order to reduce the size of the 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 tissues or organs.
[[Page 51233]]
3. Multimodal therapy: A combination of at least two types of
treatment modalities given in close proximity as a unified whole and
usually planned before any treatment has begun. There are three
types of treatment modalities: Surgery, radiation, and systemic drug
therapy (chemotherapy, hormonal therapy, and immunotherapy).
Examples of multimodal therapy include:
a. Surgery followed by chemotherapy or radiation.
b. Chemotherapy followed by surgery.
c. Chemotherapy and concurrent radiation.
4. Persistent: Failure to achieve a complete remission.
5. Progressive: The malignancy becomes more extensive after
treatment.
6. Recurrent, relapse: A malignancy that was in complete
remission or entirely removed by surgery has returned.
7. Unresectable: Surgery was performed, but the malignant tumor
was not removed. This term includes situations in which your tumor
is incompletely resected or the surgical margins are positive. It
does not include situations in which a tumor is completely resected
but you are receiving adjuvant therapy. Adjuvant therapy is
antineoplastic therapy, such as chemotherapy or radiation, given
after surgery in order to eliminate any remaining cancer cells 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 the lymphomas may
produce intermittent symptoms and signs. Therefore, we may defer
adjudicating these cases for an appropriate period after therapy is
initiated to determine whether the therapy will achieve its intended
effect, which is usually to stabilize the disease process. (See
13.00E3.) When your disease has been stabilized, we will assess
severity based on the extent of involvement of other organ systems
and residuals from therapy.
b. A change in therapy for indolent lymphomas is usually an
indicator that the therapy is not achieving its intended effect.
However, your impairment will not meet the requirements of 13.05A2
if your therapy is changed solely because you or your physician
choose to change it, not because of a failure to achieve stability.
* * * * *
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 (WHO) 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.
* * * * *
13.02 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.
* * * * *
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. 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.
B. * * *
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:
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.
OR
* * * * *
13.14 Lungs.
B. * * *
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.
* * * * *
C. Vulva or vagina, 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.
* * * * *
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
* * * * *
E. When do we need longitudinal evidence?
* * * * *
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; that is, multimodal therapy (see
113.00I2).
* * * * *
H. How long do we consider your impairment to be disabling?
* * * * *
2. * * * When the impairment(s) has been in complete remission
for at least 3 years, that is, the original tumor or a recurrence
(or relapse) and any metastases have not been evident for at least 3
years, the impairment(s)
[[Page 51234]]
will no longer meet or medically equal the criteria of a listing in
this body system.
3. * * * If you have a recurrence or relapse of your malignancy,
your impairment may meet or medically equal one of the listings in
this body system again.
* * * * *
I. What do we mean by the following terms?
1. 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. Multimodal therapy: A combination of at least two types of
treatment modalities given in close proximity as a unified whole and
usually planned before any treatment has begun. There are three
types of treatment modalities: Surgery, radiation, and systemic drug
therapy (chemotherapy, hormonal therapy, and immunotherapy).
Examples of multimodal therapy include:
a. Surgery followed by chemotherapy or radiation.
b. Chemotherapy followed by surgery.
c. Chemotherapy and concurrent radiation.
3. Persistent: Failure to achieve a complete remission.
4. Progressive: The malignancy becomes more extensive despite
treatment.
5. Recurrent, relapse: A malignancy that was 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
(non-aggressive) 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. 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 (WHO) 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.
* * * * *
113.09 Thyroid gland.
B. * * *
OR
C. Medullary carcinoma with metastases beyond the regional lymph
nodes.
* * * * *
113.13 Brain tumors. (See 113.00K4.) 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. E9-23896 Filed 10-5-09; 8:45 am]
BILLING CODE 4191-02-P
