[Federal Register Volume 74, Number 238 (Monday, December 14, 2009)]
[Proposed Rules]
[Pages 66069-66075]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-29671]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 74, No. 238 / Monday, December 14, 2009 /
Proposed Rules
[[Page 66069]]
SOCIAL SECURITY ADMINISTRATION
20 CFR Parts 404 and 416
[Docket No. SSA-2006-0114]
RIN 0960-AD78
Revised Medical Criteria for Evaluating Endocrine Disorders
AGENCY: Social Security Administration.
ACTION: Notice of proposed rulemaking.
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SUMMARY: We propose to revise the criteria in the Listing of
Impairments (the listings) that we use to evaluate claims under titles
II and XVI of the Social Security Act (Act) involving endocrine
disorders in adults and children. The proposed revisions reflect
advances in medical knowledge, information we received from medical
experts, comments we received from the public in response to an Advance
Notice of Proposed Rulemaking (ANPRM) and at an outreach policy
conference, and our adjudicative experience.
DATES: To ensure that your comments are considered, we must receive
them by no later than February 12, 2010.
ADDRESSES: You may submit comments by any one of four methods--
Internet, fax, mail, or hand-delivery. Do not submit the same comments
multiple times or by more than one method. Regardless of which method
you choose, please state that your comments refer to Docket No. SSA-
2006-0114 so that we may associate your comments with the correct
regulation.
Caution: You should be careful to include in your comments only
information that you wish to make publicly available. We strongly urge
you not to include in your comments any personal information, such as
Social Security numbers or medical information.
1. Internet: We strongly recommend this method for submitting your
comments. Visit the Federal eRulemaking portal at http://www.regulations.gov. Use the Search function of the webpage to find
docket number SSA-2006-0114, then submit your comment. Once you submit
your comment, the system will issue you a tracking number to confirm
your submission. You will not be able to view your comment immediately
as we must manually post each comment. It may take up to a week for
your comment to be viewable.
2. Fax: Fax comments to (410) 966-2830.
3. Mail: Address your comments to the Commissioner of Social
Security, P.O. Box 17703, Baltimore, Maryland 21235-7703.
4. Hand-delivery: Deliver your comments to the Office of
Regulations, Social Security Administration, 137 Altmeyer Building,
6401 Security Boulevard, Baltimore, MD 21235-6401, between 8 a.m. and
4:30 p.m., Eastern Time, business days.
Comments are available for public viewing on the Federal
eRulemaking portal at http://www.regulations.gov or in person, during
regular business hours, by arranging with the contact person identified
below.
FOR FURTHER INFORMATION CONTACT: Judy Hicks, Office of Medical Listings
Improvement, Social Security Administration, 6401 Security Boulevard,
Baltimore, Maryland 21235-6401, (410) 965-1020. For information on
eligibility or filing for benefits, call our national toll-free number,
1-800-772-1213, or TTY 1-800-325-0778, or visit our Internet site,
Social Security Online, at http://www.socialsecurity.gov.
SUPPLEMENTARY INFORMATION:
Electronic Version
The electronic file of this document is available on the date of
publication in the Federal Register at http://www.gpoaccess.gov/fr/index.html.
What revisions are we proposing?
We propose to:
Revise and expand the introductory text to the endocrine
body system for both adults (section 9.00) and children (section
109.00);
Remove all of the current adult listings in the endocrine
body system (listings 9.02-9.08); and
Remove all of the current childhood listings in the
endocrine body system (listings 109.02-109.13) and add a new listing
109.08 for children from birth to the attainment of age 6 who have
diabetes mellitus (DM) and require daily insulin.
If we publish these proposed rules as final rules, we will also
publish a Social Security Ruling (SSR) that will provide more detailed
information about specific endocrine disorders, the types of
impairments that result from endocrine disorders, and how we will
determine whether people who have endocrine disorders are disabled.
Why did we decide to propose these revisions?
These proposed revisions reflect advances in medical knowledge
about evaluating and treating endocrine disorders, as well as our
adjudicative experience. In developing these proposed rules, we used
information from a variety of sources, including:
Medical experts in the field of endocrinology, experts in
other related fields, advocacy groups for people with DM, and people
with endocrine disorders and their families;
People who make disability determinations and decisions
for us in State agencies and in our Office of Disability Adjudication
and Review; and
The published sources we list in the References section at
the end of this preamble.
We received some of this information from public comments that
responded to an ANPRM that we published in the Federal Register on
August 11, 2005. 70 FR 46792. In the ANPRM, we announced our plans to
update and revise this body system, and we invited interested people
and organizations to send us written comments and suggestions. We also
received public comments at an outreach policy conference on
``Endocrine Disorders in the Disability Programs'' that we hosted in
Atlanta, GA on November 17, 2005.\1\
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\1\ Although we indicated in the ANPRM that we would not
summarize or respond to the comments, we read and considered them
carefully. You can read the ANPRM and the comments and suggestions
we received at: https://s044a90.ssa.gov/apps10/erm/rules.nsf/5da82b031a6677dc85256b41006b7f8d/6c2a08af38f947cd8525705a006cddf9!OpenDocument. You can also read a
transcript of the policy conference at the following link: http://www.ssa.gov/disability/Transcript-Endocrine_Disorder_Policy_Conference.pdf.
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Why are we proposing these revisions?
We last published final rules making comprehensive revisions to the
[[Page 66070]]
endocrine listings on December 6, 1985. 50 FR 50068. In the preamble to
those rules, we indicated that we would periodically review and update
the listings in light of medical advances in evaluating and treating
endocrine disorders and our program experience. Since that time,
however, we have generally only extended the effective date of the
rules.\2\
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\2\ We published revisions to specific listings on July 2, 1993,
August 24, 1999, and April 24, 2002. 58 FR 36008, 64 FR 46122, and
67 FR 20018. However, these revisions were not comprehensive. The
current listings will no longer be effective as of July 1, 2010,
unless we extend them. 73 FR 31025.
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When we originally published the endocrine disorders listings, we
recognized that endocrine disorders could be of listing-level severity
either alone or because of their effects on other body systems. Since
1985, medical science has made significant advances in detecting
endocrine disorders at earlier stages, and newer treatments have
resulted in better management of these conditions. For example:
Pituitary gland disorders that suppress the production of
antidiuretic hormones (current adult listing 9.05 and childhood listing
109.05) are now treated with replacement vasopressin (also called
``antidiuretic hormone,'' or ADH), which prevents diuresis (increased
excretion of urine) and dehydration;
Modern tests for hyperfunction of the adrenal cortex are
more sensitive and accurate than the test required by current listing
109.06A, and provide better information for evaluating and controlling
the symptoms and complications associated with this disorder; and
Hormone deficiencies that affect the adrenal gland's
ability to produce cortisol and aldosterone (current adult listing 9.06
and childhood listings 109.07 and 109.11) are now treated with
replacement drugs that control adrenal gland disorders.
Because of advances in medical treatment and detection, most
endocrine disorders do not reach listing-level severity because they do
not become sufficiently severe or do not remain at a sufficient level
of severity long enough to meet our 12-month duration requirement. This
is true even for people who have recurrent episodes of hypoglycemia or
of diabetic acidosis (also called diabetic ketoacidosis, or DKA), a
serious outcome of uncontrolled blood glucose levels. Current listings
9.08B and 109.08A, which provide criteria for people who have recurrent
episodes of DKA, and listing 109.08B, which provides a criterion for
children who have recurrent episodes of hypoglycemia, reflect an
earlier view that people with wide fluctuations in their blood glucose
levels had uncontrollable DM. We consulted with endocrinologists,
diabetologists, and other medical experts who treat DM, and they
indicated that the current listings reflect only inadequate glucose
regulation. The information we obtained from these experts and relevant
medical references demonstrates that adequate glucose regulation is
achievable with improved treatment options, such as a wider range of
insulin products.
For these reasons, we believe that, with one exception, we should
no longer have listings in sections 9.00 and 109.00 based on endocrine
disorders alone, and we are proposing to remove all such current
endocrine listings. The sole exception is for children under age 6 who
have DM and require daily insulin. These children present a unique
situation for which we are proposing a new listing, as we explain
below.
Many of the current listings in the endocrine system are
``reference listings''--listings that are met by satisfying the
criteria of other listings. Endocrine glands regulate the functioning
of organs and other glands, and endocrine disorders can cause problems
that are of listing-level severity and that meet the duration
requirement when they affect those organs or other glands. We evaluate
these effects under other body system listings.\3\ For example, DM can
lead to:
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\3\ Some endocrine cancers result in death because of their
direct effects on endocrine glands. We account for such impairments
in the malignant neoplastic diseases sections of our listings,
sections 13.00 and 113.00.
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Growth impairment in children, which we evaluate under the
growth disorders listings in section 100.00;
Amputations, which we evaluate under the musculoskeletal
disorders listings in sections 1.00 and 101.00;
Visual disorders, which we evaluate under the special
senses and speech listings in sections 2.00 and 102.00;
Cardiovascular disease, which we evaluate under the
cardiovascular disorders listings in sections 4.00 and 104.00;
Kidney disease, which we evaluate under the genitourinary
disorders listings in sections 6.00 and 106.00;
Neuropathies, which we evaluate under the neurological
disorders listings in sections 11.00 and 111.00; and
Clinical depression, which we evaluate under the mental
disorders listings in sections 12.00 and 112.00.
The reference listings in sections 9.00 and 109.00 simply cross-
refer to the listings in other body systems appropriate for these
impairments. For example, current listing 9.08C, for DM with retinitis
proliferans (a visual disorder), cross-refers to listing 2.02, 2.03, or
2.04 in the special senses and speech body system. Listing 9.08C is
redundant because we evaluate the visual effects of retinitis
proliferans using listing 2.02, 2.03, or 2.04.\4\ We do not need any of
the reference listings for endocrine disorders and we propose to remove
them all. We have been removing reference listings from all of the body
systems as we revise them, and the changes we are proposing in this
NPRM are consistent with that approach.\5\
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\4\ There are currently five reference listings in the endocrine
system for adults and twelve reference listings in the endocrine
system for children--9.02, 9.03B, 9.04C, 9.06, 9.08C, 109.02B2,
109.04B, 109.05C, 109.08C, 109.08D, 109.09B, 109.09C, 109.09D,
109.09E, 109.10, 109.11C, and 109.13. Eight of twelve childhood
reference listings refer to listing 100.002A or B in the growth
disorders listings, including listing 109.13, which refers to the
criteria in ``the appropriate body system.'' Current adult listing
9.08A, although not technically a reference listing, contains
identical criterion for peripheral neuropathy as in listing 11.14 in
the neurological body system.
\5\ Examples of such recent changes include the ``Revised
Medical Criteria for Evaluating Digestive Disorders,'' 72 FR 59398
(October 19, 2007), and the ``Revised Medical Criteria for
Evaluating Immune System Disorders,'' 73 FR 14570 (March 18, 2008).
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We considered whether we could propose revised criteria for the
endocrine disorder listings instead of proposing to remove them all. We
decided not to propose such criteria for two reasons. First, because
the effects of the impairments vary too widely, we would not have been
able to conclude that all people whose endocrine disorders met one of
the alternative listings we considered would be unable to perform any
gainful activity, the standard of severity we require for a listing.
Second, some of the alternative listings we considered were so severe
that people whose endocrine disorders would have met those criteria
would also have impairments that met listings in other body systems.
Therefore, such listings would have been unnecessary.
Why are we proposing to include guidance for evaluating endocrine
disorders in sections 9.00 and 109.00 when there would be no endocrine
disorders listings other than proposed listing 109.08?
Each body system is organized in two parts: an introduction,
followed by specific listings. Sections 404.1525(c) and 416.925(c). In
proposed section 9.00 (the adult listings), however, we are providing
only the introduction in order to explain how we evaluate endocrine
[[Page 66071]]
disorders and the impairments they may cause. We are not providing any
specific listing criteria.\6\
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\6\ We are proposing minor changes in our regulations to reflect
this change. Sections 404.1525 and 416.925.
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We are proposing similar guidance in the introductory text of
section 109.00 in the childhood endocrine listings. We also provide
guidance on how we would evaluate disability claims for children whose
DM does not meet proposed listing 109.08. We do not include guidance
for evaluating the long-term complications of DM related to chronic
hyperglycemia, as we do for adults in proposed section 9.00B5, because
such complications are rare in children.
As we explain in the proposed sections 9.00C and 109.00D,
endocrine-related impairments that do not meet or medically equal any
listing may nonetheless result in a finding of disability for both
adults and children. We may find adults to be disabled based on their
residual functional capacity, age, education, and work experience.
Sections 404.1520(g) and 416.920(g). We may find children who apply for
SSI benefits to be disabled based on impairments that functionally
equal the listings. Sections 416.924(d) and 416.926a.
Why are we proposing new listing 109.08 for children from birth to the
attainment of age 6 who have DM and require daily insulin?
Careful monitoring of blood glucose levels is crucial to the health
and survival of both adults and children with DM. Children under age 6
who have DM and require daily insulin to regulate glucose present a
unique situation because they generally have not developed adequate
cognitive capacity for recognizing and responding to hypoglycemic
symptoms. To ensure the child's survival, an adult must monitor and
supervise the child's insulin, food intake, and physical activity 24
hours a day to control the child's blood glucose level. This degree of
help satisfies the fifth example of functional equivalence in the last
paragraph of our functional equivalence regulation: the requirement for
24-hour-a-day supervision of a child for medical reasons. Section
416.926a(m)(5). Since listings are rules that we use to find disability
in all people whose impairments meet their criteria, and since under
functional equivalence example 5 all children under age 6 who have DM
and require daily insulin are disabled, we believe it is simpler to
provide a listing for these children.
Why are we not proposing a listing for children age 6 and older who
have DM and require daily insulin, and how will we evaluate children of
any age with DM who do not require daily insulin?
We are not proposing a listing for children age 6 and older who
have DM and require daily insulin because many of these children do not
have the same medical need for adult help as younger children.
Generally, children develop the cognitive awareness needed to recognize
the symptoms of hypoglycemia and to seek help by age 6. As they mature,
they should also be able to increasingly take part in self-care
activities, such as:
Participating in blood glucose testing;
Self-administering insulin;
Interpreting blood glucose testing results;
Determining proper dosages of multiple types of insulin;
Following special diets and schedules for snacks and
meals;
Understanding the importance of engaging in recommended
physical activities;
Managing adjustments of insulin dosing and fluid intake in
response to fluctuating glucose levels during acute illness; and
Recognizing the importance of maintaining desirable
glucose levels to prevent later complications.
Some of the children age 6 and older who have DM and require daily
insulin will have impairments resulting from their DM that meet or
medically equal listings in other body systems. Others will need the
same level of help with their DM as children under age 6. We will find
that those children have impairments that functionally equal the
listings because they satisfy the functional equivalence example of a
requirement for 24-hour-a-day supervision for medical reasons. Other
children who do not need this level of help will nevertheless have
impairments that functionally equal the listings pursuant to our rules
for evaluating disability in children. Sections 416.926a and 416.924a.
The same is true for DM in a child of any age (that is, from birth
to age 18) who does not require daily insulin. We will consider any
impairment resulting from DM under the appropriate listing criteria in
any affected body system. If the child's impairment or combination of
impairments does not meet or medically equal a listing in any body
system, we will determine whether the impairment(s) functionally equals
the listings. Sections 416.924a and 416.926a.
Would our proposal to remove endocrine listings affect people who are
already receiving benefits based on endocrine disorders?
If these rules become final, we will not terminate any person's
disability benefits solely because we have removed any endocrine
disorder listing, nor will we review prior allowances based on the
endocrine disorders listings under the new rules. Unless we are
otherwise required to do so (for example, by statute), we do not
readjudicate previously decided cases when we revise our listings. We
must periodically conduct continuing disability reviews to determine
whether beneficiaries are still disabled. Sections 404.1589 and
416.989. When we do, we will not find that a person's disability has
ended based on a change in a listing. In most cases, we must show that
the person's impairment(s) has medically improved and that any medical
improvement is ``related to the ability to work.'' Sections 404.1594
and 416.994. Even where the impairment(s) has medically improved, our
regulations provide that the improvement is not ``related to the
ability to work'' if it continues to meet or medically equal the ``same
listing section used to make our most recent favorable decision.'' This
is true even if we have deleted the listing section we used to make the
most recent favorable decision. Sections 404.1594(c)(3)(i) and
416.994(b)(2)(iv)(A).\7\ When we find that medical improvement is not
related to the ability to work (or, in the case of a person under age
18, the impairment still meets or medically equals the prior listing),
we will find that disability continues, unless an exception to medical
improvement applies.
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\7\ Our regulations contain a similar provision for continuing
disability reviews for children eligible for SSI based on
disability. See Sec. 416.994a(b)(2).
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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).
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.
[[Page 66072]]
Clarity of These Rules
Executive Order 12866 requires each agency to write all rules in
plain language. In addition to your substantive comments on these
proposed rules, we invite your comments on how to make them easier to
understand.
For example:
Would more, but shorter, sections be better?
Are the requirements in the rules clearly stated?
Have we organized the material to suit your needs?
Could we improve clarity by adding tables, lists, or
diagrams?
What else could we do to make the rules easier to
understand?
Do the rules contain technical language or jargon that is
not clear?
Would a different format make the rules easier to
understand, e.g. grouping and order of sections, use of headings,
paragraphing?
When Will We Start To Use These Rules?
We will not use these rules until we evaluate public comments and
publish final rules in the Federal Register. All final rules we issue
include an effective date. We will continue to use our current rules
until that date. If we publish final rules, we will include a summary
of those relevant comments we received along with responses and an
explanation of how we will apply the new rules.
Regulatory Procedures
Executive Order 12866
Note to reviewers: This is a placeholder while we await program
estimates. 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 and
were subject to OMB review.
Regulatory Flexibility Act
We certify that these proposed rules would not have a significant
economic impact on a substantial number of small entities because they
affect only individuals. Therefore, a regulatory flexibility analysis
is not required under the Regulatory Flexibility Act, as amended.
Paperwork Reduction Act
These proposed rules do not create any new or affect any existing
collections and, therefore, do not require Office of Management and
Budget approval under the Paperwork Reduction Act.
References
We consulted the following references when we developed these
proposed rules:
Anderson, Barbara and Richard L. Rubin, Practical Psychology for
Diabetes Clinicians: Effective Techniques for Key Behavioral Issues,
2nd Edition, McGraw-Hill, New York (2003).
Becker, Dorothy J. and Christopher M. Ryan, ``Hypoglycemia in
Children with Type 1 Diabetes Mellitus: Risk Factors, Cognitive
Function, and Management,'' Endocrinology and Metabolism Clinics,
Vol. 28, Issue 4, 883-900 (December 1999), available at: http://www.mdconsult.com/das/article/body/94692077-2/jorg=journal&source=&sp=11158267&sid=0/N/158829/1.html.
Cooke, David W. and Leslie Plotnick, ``Management of Diabetic
Ketoacidosis in Children and Adolescents,'' Pediatrics in Review,
Pediatr. Rev. 2008; 29; 431-436, available at: http://pedsinreview.aappublications.org/cgi/content/full/29/12/431.
Cooke, David W. and Leslie Plotnick, ``Type 1 Diabetes Mellitus in
Pediatrics,'' Pediatrics in Review, Pediatr. Rev. 2008; 29; 374-385,
available at: http://pedsinreview.aappublications.org/cgi/content/full/29/11/374.
Cowell, Kristi M., ``Focus on Diagnosis: Type 2 Diabetes Mellitus,''
Pediatrics in Review, Pediatr. Rev. 2008; 29; 289-292, available at:
http://pedsinreview.aappublications.org/cgi/content/full/29/8/289.
Feld, Stanley, ``Medical Guidelines for the Management of Diabetes
Mellitus: The AACE System of Intensive Diabetes Self Management--
2002 Update,'' The American Association of Clinical
Endocrinologists, Endocrine Practice, Vol. 8, Supplement, (January/
February 2002), available at: http://www.gata.edu.tr/dahilibilimler/nefroloji/dosyalar/diabetes_2002.pdf.
Johns Hopkins Hospital, ``Type 2 Diabetes Drug Boom: Is Newer
Better?'' The Johns Hopkins Medical Letter: Health After 50, Vol.
19, No. 6 (August 2007).
Kasper, D., Endocrinology and Metabolism, Harrison's Principles of
Internal Medicine, 16th Edition, 2088-2299, McGraw-Hill
Professional, New York (2004).
Kliegman, Robert M., Richard E. Behrman, Hal B. Jensen, and Bonita
F. Stanton, ``The Endocrine System,'' Nelson Textbook of Pediatrics,
18th Edition, WB Saunders Co., Philadelphia, PA (2004).
Silverstein, Janet, et al., ``Care of Children and Adolescents with
Type 1 Diabetes,'' Diabetes Care, Vol. 28, No. 1, 186-212, American
Diabetes Association, Inc., Alexandria, VA (January 2005), available
at: http://care.diabetesjournals.org/cgi/reprint/28/1/186.
Social Security Administration, ``Endocrine Disorders in the
Disability Programs.'' Transcript of conference held in Atlanta, GA,
November 17, 2005, available at: http://www.ssa.gov/disability/Transcript-Endocrine_Disorder_Policy_Conference.pdf.
Sperling, Mark A., guest editor, ``Diabetes Mellitus in Children,''
Pediatric Clinics of North America, Vol. 52, No. 6, 1533-1872
(December 2005), available at: http://www.mdconsult.com/das/article/body/94692077-4/jorg=journal&source=&sp=15876443&sid=0/N/505590/1.html?issn=0031-3955&issue_id=17939.
Taras, Howard L., ``The Role of the School Nurse in Providing School
Health Services,'' Committee on School Health, American Academy of
Pediatrics, Pediatrics, Vol. 108, No. 5, 1231-1232 (November 2001),
available at: http://aappolicy.aappublications.org/cgi/reprint/pediatrics;108/5/1231.pdf.
We will make these references available to you for inspection if
you are interested in reading them. Please make arrangements with the
contact person shown in this preamble if you would like to review any
reference materials.
(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
20 CFR Part 404
Administrative practice and procedure; Blind, Disability benefits;
Old-age, Survivors, and Disability Insurance; Reporting and
recordkeeping requirements; Social Security.
20 CFR Part 416
Administrative practice and procedure; Blind; Disability benefits;
Old age, Public assistance programs; Reporting and recordkeeping
requirements; Supplemental Security Income (SSI).
Dated: September 10, 2009.
Michael J. Astrue,
Commissioner of Social Security.
For the reasons set out in the preamble, we propose to amend 20 CFR
part 404 subpart P and part 416 subpart I 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).
[[Page 66073]]
2. Amend Sec. 404.1525 by revising paragraph (c)(1) and the first
sentence of paragraph (c)(3) to read as follows:
Sec. 404.1525 Listing of impairments in appendix 1.
* * * * *
(c) How do we use the listings? (1) Most body system sections in
parts A and B of appendix 1 are in two parts: An introduction, followed
by the specific listings.
* * * * *
(3) In most cases, the specific listings follow the introduction in
each body system, after the heading, Category of Impairments. * * *
* * * * *
3. Amend appendix 1 to subpart P of part 404 by:
a. Revising item 10 of the introductory text before part A;
b. Revising the body system name for section 9.00 in the Part A
table of contents;
c. Revising section 9.00 in part A;
d. Removing sections 9.01 through 9.08;
e. Revising the body system name for section 109.00 in the Part B
table of contents; and
f. Revising section 109.00 in part B.
The revisions read as follows:
Appendix 1 to Subpart P of Part 404--Listing of Impairments
* * * * *
10. Endocrine Disorders (9.00 and 109.00): [DATE 8 YEARS FROM THE
EFFECTIVE DATE OF THE FINAL RULES].
* * * * *
Part A
* * * * *
9.00 Endocrine Disorders.
* * * * *
9.00 Endocrine Disorders
A. What is an endocrine disorder?
An endocrine disorder is a medical condition that causes a hormonal
imbalance. When an endocrine gland functions abnormally, producing
either too much of a specific hormone (hyperfunction) or too little
(hypofunction), the hormonal imbalance can cause various complications
in the body. The major glands of the endocrine system are the
pituitary, thyroid, parathyroid, adrenal, and pancreas.
B. How do we evaluate the effects of endocrine disorders? We
evaluate impairments that result from endocrine disorders under the
listings for other body systems. For example:
1. Pituitary gland disorders can disrupt hormone production and
normal functioning in other endocrine glands and in many body systems.
The effects of pituitary gland disorders vary depending on which
hormones are involved. For example, when pituitary hypofunction affects
water and electrolyte balance in the kidney and leads to diabetes
insipidus, we evaluate the effects of recurrent dehydration under 6.00.
2. Thyroid gland disorders affect the body's sympathetic nervous
system and normal metabolism. We evaluate thyroid-related changes in
blood pressure and heart rate that cause arrhythmias or other cardiac
dysfunction under 4.00; thyroid-related weight loss under 5.00;
hypertensive cerebrovascular accidents (strokes) under 11.00; and
cognitive limitations, mood disorders, and anxiety under 12.00.
3. Parathyroid gland disorders affect calcium levels in bone,
blood, nerves, muscle, and other body tissues. We evaluate parathyroid-
related osteoporosis and fractures under 1.00; abnormally elevated
calcium levels in the blood (hypercalcemia) that lead to cataracts
under 2.00; kidney failure under 6.00; and recurrent abnormally low
blood calcium levels (hypocalcemia) that lead to increased excitability
of nerves and muscles, such as tetany and muscle spasms, under 11.00.
4. Adrenal gland disorders affect bone calcium levels, blood
pressure, metabolism, and mental status. We evaluate adrenal-related
osteoporosis with fractures that compromises the ability to walk or to
use the upper extremities under 1.00; adrenal-related hypertension that
worsens heart failure or causes recurrent arrhythmias under 4.00;
adrenal-related weight loss under 5.00; and mood disorders under 12.00.
5. Diabetes mellitus and other pancreatic gland disorders disrupt
the production of several hormones, including insulin, that regulate
metabolism and digestion. Insulin is essential to the absorption of
glucose from the bloodstream into body cells for conversion into
cellular energy. The most common pancreatic gland disorder is diabetes
mellitus (DM). There are two major types of DM: Type 1 and type 2. Type
1 DM--previously known as ``juvenile diabetes'' or ``insulin-dependent
diabetes mellitus'' (IDDM)--is an absolute deficiency of insulin
production that commonly begins in childhood and continues throughout
adulthood. Treatment of type 1 DM always requires lifelong daily
insulin. With type 2 DM--previously known as ``adult-onset diabetes
mellitus'' or ``non-insulin-dependent diabetes mellitus'' (NIDDM)--the
body's cells resist the effects of insulin, impairing glucose
absorption and metabolism. Treatment of type 2 DM generally requires
lifestyle changes, such as increased exercise and dietary modification,
and sometimes insulin in addition to other medications.
a. Hyperglycemia. Both types of DM cause hyperglycemia, which is an
abnormally high level of blood glucose that may produce acute and long-
term complications. Acute complications of hyperglycemia include
diabetic ketoacidosis. Long-term complications of DM are related to
chronic hyperglycemia.
i. Diabetic ketoacidosis (DKA). DKA is a potentially life-
threatening complication of DM in which the chemical balance of the
body becomes dangerously hyperglycemic and acidic. It is an acute
condition resulting from a severe insulin deficiency, which can occur
due to missed or inadequate daily insulin therapy, or in association
with an acute illness. It usually requires hospital treatment to
correct the acute complications of dehydration, electrolyte imbalance,
and insulin deficiency. You may have serious complications resulting
from your treatment, which we evaluate under the affected body system.
For example, we evaluate cardiac arrhythmias under 4.00, intestinal
necrosis under 5.00, and cerebral edema and seizures under 11.00.
Recurrent episodes of DKA may result from mood or eating disorders,
which we evaluate under 12.00.
ii. Chronic hyperglycemia. Chronic hyperglycemia, which is
longstanding abnormally high levels of blood glucose, leads to long-
term diabetic complications by disrupting nerve and blood vessel
functioning. This disruption can have many different effects in other
body systems. For example, we evaluate diabetic peripheral
neurovascular disease that leads to gangrene and subsequent amputation
of an extremity under 1.00; diabetic retinopathy under 2.00; coronary
artery disease and peripheral vascular disease under 4.00; diabetic
gastroparesis that results in abnormal gastrointestinal motility under
5.00; diabetic nephropathy under 6.00; poorly healing bacterial and
fungal skin infections under 8.00; diabetic peripheral and sensory
neuropathies under 11.00; and cognitive impairments, depression, and
anxiety under 12.00.
b. Hypoglycemia. People with DM may experience episodes of
hypoglycemia, which is an abnormally low level of blood glucose. Most
adults recognize the symptoms of hypoglycemia and reverse them by
consuming substances containing
[[Page 66074]]
glucose. Severe hypoglycemia can lead to complications, including
seizures or loss of consciousness, which we evaluate under 11.00, or
altered mental status and cognitive deficits, which we evaluate under
12.00.
C. How do we evaluate endocrine disorders that do not have effects
that meet or medically equal the criteria of any listing in other body
systems? If your impairment(s) does not meet or medically equal a
listing in another body system, you may or may not have the residual
functional capacity to engage in substantial gainful activity. In this
situation, we proceed to the fourth and, if necessary, the fifth steps
of the sequential evaluation process in Sec. Sec. 404.1520 and
416.920. When we decide whether you continue to be disabled, we use the
rules in Sec. Sec. 404.1594, 416.994, and 416.994a.
* * * * *
Part B
* * * * *
109.00 Endocrine Disorders.
* * * * *
109.00 Endocrine Disorders
A. What is an endocrine disorder?
An endocrine disorder is a medical condition that causes a hormonal
imbalance. When an endocrine gland functions abnormally, producing
either too much of a specific hormone (hyperfunction) or too little
(hypofunction), the hormonal imbalance can cause various complications
in the body. The major glands of the endocrine system are the
pituitary, thyroid, parathyroid, adrenal, and pancreas.
B. How do we evaluate the effects of endocrine disorders? The only
listing in this body system addresses children from birth to the
attainment of age 6 who have diabetes mellitus (DM) and require daily
insulin. We evaluate other impairments that result from endocrine
disorders under the listings for other body systems. For example:
1. Pituitary gland disorders can disrupt hormone production and
normal functioning in other endocrine glands and in many body systems.
The effects of pituitary gland disorders vary depending on which
hormones are involved. For example, when pituitary growth hormone
deficiency in growing children limits bone maturation and results in
pathological short stature, we evaluate under 100.00. When pituitary
hypofunction affects water and electrolyte balance in the kidney and
leads to diabetes insipidus, we evaluate the effects of recurrent
dehydration under 106.00.
2. Thyroid gland disorders affect the body's sympathetic nervous
system and normal metabolism. We evaluate thyroid-related changes in
linear growth under 100.00; thyroid-related changes in blood pressure
and heart rate that cause cardiac arrhythmias or other cardiac
dysfunction under 104.00; thyroid-related weight loss under 105.00; and
cognitive limitations, mood disorders, and anxiety under 112.00.
3. Parathyroid gland disorders affect calcium levels in bone,
blood, nerves, muscle, and other body tissues. We evaluate parathyroid-
related osteoporosis and fractures under 101.00; abnormally elevated
calcium levels in the blood (hypercalcemia) that lead to cataracts
under 102.00; kidney failure under 106.00; and recurrent abnormally low
blood calcium levels (hypocalcemia) that lead to increased excitability
of nerves and muscles, such as tetany and muscle spasms, under 111.00.
4. Adrenal gland disorders affect bone calcium levels, blood
pressure, metabolism, and mental status. We evaluate adrenal-related
linear growth impairments under 100.00; adrenal-related osteoporosis
with fractures that compromises the ability to walk or to use the upper
extremities under 101.00; adrenal-related hypertension that worsens
heart failure or causes recurrent arrhythmias under 104.00; adrenal-
related weight loss under 105.00; and mood disorders under 112.00.
5. Diabetes mellitus and other pancreatic gland disorders disrupt
the production of several hormones, including insulin, that regulate
metabolism and digestion. Insulin is essential to the absorption of
glucose from the bloodstream into body cells for conversion into
cellular energy. The most common pancreatic gland disorder is diabetes
mellitus (DM). There are two major types of DM: type 1 and type 2. Type
1 DM--previously known as ``juvenile diabetes'' or ``insulin-dependent
diabetes mellitus'' (IDDM)--is an absolute deficiency of insulin
secretion that commonly begins in childhood and continues throughout
adulthood. Treatment of type 1 DM always requires lifelong daily
insulin. With type 2 DM--previously known as ``adult-onset diabetes
mellitus'' or ``non-insulin-dependent diabetes mellitus'' (NIDDM)--the
body's cells resist the effects of insulin, impairing glucose
absorption and metabolism. Although less common than type 1 DM in
children, type 2 DM is increasingly being diagnosed prior to age 18.
Treatment of type 2 DM generally requires lifestyle changes, such as
increased exercise and dietary modification, and sometimes insulin in
addition to other medications.
a. Hyperglycemia. Both types of DM cause hyperglycemia, which is an
abnormally high level of blood glucose that may produce acute and long-
term complications. Acute complications of hyperglycemia include
diabetic ketoacidosis. Long-term complications of DM are related to
chronic hyperglycemia, but are rare in children.
b. Diabetic ketoacidosis (DKA). DKA is a potentially life-
threatening complication of DM in which the chemical balance of the
body becomes dangerously hyperglycemic and acidic. It is an acute
condition resulting from a severe insulin deficiency, which can occur
due to missed or inadequate daily insulin therapy, or in association
with acute illness. It usually requires hospital treatment to correct
the acute complications of dehydration, electrolyte imbalance, and
insulin deficiency. You may have serious complications resulting from
your treatment, which we evaluate under the affected body system. For
example, we evaluate cardiac arrhythmias under 104.00, intestinal
necrosis under 105.00, and cerebral edema and seizures under 111.00.
Recurrent episodes of DKA in adolescents may result from mood or eating
disorders, which we evaluate under 112.00.
c. Hypoglycemia. Children with DM may experience episodes of
hypoglycemia, which is an abnormally low level of blood glucose. Most
children age 6 and older recognize the symptoms of hypoglycemia and
reverse them by consuming substances containing glucose. Severe
hypoglycemia can lead to complications, including seizures or loss of
consciousness, which we evaluate under 111.00, or altered mental
status, cognitive deficits, and permanent brain damage, which we
evaluate under 112.00.
C. How do we evaluate DM in children?
Listing 109.08 is only for children with DM who have not attained
age 6 and who require daily insulin. For all other children (that is,
children with DM who are age 6 or older and require daily insulin, and
children of any age with DM who do not require daily insulin), we
determine if an impairment that results from DM, or a combination of
impairments, meets or medically equals the criteria of a listing in
another body system, or functionally equals the listings under the
criteria in Sec. 416.926a, considering the factors in Sec. 416.924a.
For example, a child age 6 or older who has a medical need for 24-hour-
a-day adult supervision of insulin treatment, food intake, and physical
activity to ensure survival will have an impairment
[[Page 66075]]
that functionally equals the listings based on the example in Sec.
416.926a(m)(5).
D. How do we evaluate other endocrine disorders that have effects
that do not meet or medically equal the criteria of any listing in
other body systems? If your impairment(s) does not meet or medically
equal a listing in another body system, we will consider whether your
impairment(s) functionally equals the listings under the criteria in
Sec. 416.926a, considering the factors in Sec. 416.924a. When we
decide whether you continue to be disabled, we use the rules in Sec.
416.994a.
109.01 Category of Impairments, Endocrine.
109.08 Any type of diabetes mellitus in a child who requires daily
insulin and has not attained age 6. Consider under a disability until
the attainment of age 6. Thereafter, evaluate the diabetes mellitus
according to the rules in 109.00B5 and C.
* * * * *
PART 416--SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND
DISABLED
4. The authority citation for subpart I of part 416 continues to
read as follows:
Authority: Secs. 221(m), 702(a)(5), 1611, 1614, 1619, 1631(a),
(c), (d)(1), and (p) and 1633 of the Social Security Act (42 U.S.C.
421(m), 902(a)(5), 1382, 1382c, 1382h, 1383(a), (c), (d)(1), and
(p), and 1383(b); secs. 4(c) and 5, 6(c)-(e), 14(a), and 15, Pub. L.
98-460, 98 Stat. 1794, 1801, 1802, and 1808 (42 U.S.C. 421 note, 423
note, and 1382h note).
5. Amend Sec. 416.925 by revising paragraph (c)(1) and the first
sentence of paragraph (c)(3) to read as follows:
Sec. 416.925 Listing of impairments in appendix 1 of subpart P of
part 404 of this chapter.
* * * * *
(c) How do we use the listings? (1) Most body system sections in
parts A and B of appendix 1 are in two parts: an introduction, followed
by the specific listings.
* * * * *
(3) In most cases, the specific listings follow the introduction in
each body system, after the heading, Category of Impairments. * * *
* * * * *
[FR Doc. E9-29671 Filed 12-11-09; 8:45 am]
BILLING CODE 4191-02-P