Revised Medical Criteria for Evaluating Endocrine Disorders, 19692-19698 [2011-8389]

Agencies

• Social Security Administration

[Federal Register Volume 76, Number 68 (Friday, April 8, 2011)]
[Rules and Regulations]
[Pages 19692-19698]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8389]


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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: Final Rules.

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SUMMARY: We are revising 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 revisions reflect our adjudicative experience, 
advances in medical knowledge, information from medical experts, and 
comments we received from the public in response to an advance notice 
of proposed rulemaking (ANPRM), a notice of proposed rulemaking (NPRM), 
and at an outreach policy conference.

DATES: These rules are effective June 7, 2011.

FOR FURTHER INFORMATION CONTACT: Judy Hicks, Social Insurance 
Specialist, 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: 

Background

    We are making final the rules for evaluating endocrine disorders 
that we proposed in an NPRM we published in the Federal Register on 
December 14, 2009 (74 FR 66069). The preamble to the NPRM discussed the 
changes from the current rules and our reasons for proposing those 
changes. To the extent that we are adopting the proposed rules as 
published, we are not repeating that information here. Interested 
readers may refer to the preamble to the NPRM.\1\
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    \1\ The NPRM is available at https://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480a6a145.
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What are the listings and how do we use them?

    Listings describe medical conditions that are so severe that we 
presume any person who has a medical condition(s) that satisfies the 
criteria of a listing is unable to perform any gainful activity and, 
therefore, is disabled. The inability to work must also have lasted or 
be expected to last for at least 12 continuous months or be expected to 
result in death; we call this provision ``the duration requirement.'' 
\2\ Thus, the listings are special rules that provide us with a 
mechanism to identify claims that should clearly be allowed. We use 
listings only to allow claims. We do not deny any claim solely because 
a person's medical condition(s) does not satisfy a listing.
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    \2\ Sections 216(i), 223(d), and 1614(a)(3) of the Act. See also 
Sec. Sec.  404.1509, 404.1520, 416.909, and 416.920 of our 
regulations.
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Why are we revising the listings for endocrine disorders?

    We are revising the listings for endocrine disorders because 
medical science has made significant advances in detecting endocrine 
disorders at earlier stages and newer treatments have resulted in 
better management of these conditions since we last published final 
rules making comprehensive revisions to the endocrine listings in 1985. 
Consequently, 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. Therefore, we have determined that, with 
the exception of children under age 6 who have diabetes mellitus (DM) 
and require daily insulin, we should no longer have listings in 
sections 9.00 and 109.00 based on endocrine disorders alone.

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\
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    \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 our 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.

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[[Page 19693]]

Public Comments on the NPRM

    In the NPRM, we provided the public a 60-day comment period, which 
ended on February 12, 2010. We received 16 public comment letters. The 
comments came from national medical organizations, advocacy groups, a 
national group of Social Security claimants' representatives, 
individual State agencies, a Congressman, and members of the public.
    We provide below summaries of the significant comments that were 
relevant to this rulemaking and our responses to those comments. We did 
not summarize or respond to some of the comments we received. Some 
commenters supported the proposed changes and noted provisions with 
which they agreed. We appreciate those comments, but they do not 
require a response. Some commenters also sent us comments on subjects 
that were unrelated to the proposed rules. These comments were outside 
the scope of the proposed rulemaking, and we have not responded to 
them.
    Comment: Several commenters asked us to continue to recognize DM as 
a disability and not to increase the burden on claimants to prove 
disability on the basis of DM. Another commenter, representing several 
physicians in a group practice, disagreed with ``changes deleting 
diabetes.'' That commenter said that a significant proportion of their 
patients have blindness, renal failure, vascular disease, and multiple 
amputations.
    Response: We will continue to recognize DM as a potential cause of 
disability, but we are removing the prior listings because they no 
longer accurately identify persons who are disabled. Contrary to what 
some of the commenters seemed to think, we will still consider DM to be 
a medically determinable impairment that can result in disability, and 
we will continue to consider its effects under our listings. For 
example, we have listings in other body systems for blindness, renal 
failure, vascular disease, and amputations. We are removing only the 
specific DM listings.
    When adults' medical conditions do not satisfy a listing, we must 
assess the particular functional effects of their impairments; that is, 
we must determine their ``residual functional capacity'' (RFC). 
Considering the RFC, we then determine whether they can do any past 
relevant work, or if they cannot, any other work that exists in the 
national economy, considering their RFC, age, education, and previous 
work experience.\4\ Most persons with DM who qualified for disability 
benefits under the prior rules did so based on their RFC, not under the 
listings we are removing. Also, many persons with DM have other medical 
conditions that meet listings in other body systems due to 
complications of DM.
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    \4\ The definition of disability is different for children who 
claim disability benefits under title XVI, but the sequential 
evaluation process for children also includes a step at which we 
consider the particular functional effects of the child's medical 
condition(s), called ``functional equivalence.'' Act, section 
1614(a)(3)(C); Sec. Sec.  416.906, 416.924, and 416.926a.
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    When a person qualifies for disability benefits under a listing, we 
continue to use that same listing when we later determine if he or she 
is still disabled. See Sec. Sec.  404.1594(c)(3)(i), 416.994(b)(2)(iv), 
and 416.994a(b)(2). This rule applies even if we have removed or 
changed the listing since we last found that the beneficiary was 
disabled. For this reason, we will not find that a beneficiary's 
disability has ended solely because we have removed the DM listings or 
any other endocrine disorder listing. Unless we are otherwise required 
to do so (for example, by statute), we do not readjudicate cases 
because we have revised our listings.
    Comment: Several commenters said that not all persons can control 
their DM all of the time and that treatment of any sort is often 
inadequate. One of these commenters stated that our proposal to 
eliminate all listings for DM did not consider the small subset of 
persons with DM who will continue to experience severe fluctuations in 
blood glucose levels despite their best efforts at treatment. This 
commenter recommended that we have listings that consider severe 
fluctuations in blood glucose levels and the accompanying health 
problems that limit a person's ability to work. One commenter said that 
DM can never be controlled completely; another commenter thought that 
the proposed rules implied that DM was curable.
    Some commenters thought that we assumed that all claimants had full 
access to state-of-the-art healthcare. Some mentioned serious outcomes 
of long-term, chronic fluctuations in blood glucose on other body 
systems. Some also mentioned that some persons with fluctuations in 
blood glucose experience symptoms and signs that are not covered by 
listings in other body systems. One commenter was concerned that our 
proposal to remove the DM listings might imply to our adjudicators that 
we want them to deny more cases involving DM. Another commenter 
believed that the proposed rules implied that persons with uncontrolled 
DM must be noncompliant with treatment. This commenter recommended that 
we include substantial guidance on the complexity of managing and 
controlling DM and guidance about how DM can intrude on the ability to 
work.
    Response: We did not mean to give the impression in the NPRM that 
there are no persons with uncontrolled DM or that all persons have 
access to healthcare or the best possible treatment. We acknowledge 
that some persons do have difficulty controlling their blood glucose 
and that some of them will be disabled. We also agree with the 
commenters that there are valid reasons for some persons' blood glucose 
levels to fluctuate, including hypoglycemia unawareness, mental 
impairments that interfere with their ability to adequately monitor and 
treat their conditions, and inadequate treatment. For those reasons, we 
include guidance about problems associated with fluctuating blood 
glucose levels and their effects, including diabetic ketoacidosis (DKA) 
and hypoglycemia. This guidance is in 9.00B5 for adults and 109.00B5 
for children.
    We are not including a listing for fluctuating blood glucose levels 
and the medical problems it causes because the reasons are highly 
variable, and we cannot provide criteria that would reliably identify 
persons with listing-level impairments based on fluctuating blood 
glucose levels. In order to determine whether persons with fluctuating 
blood glucose levels are disabled, we must assess an adult's RFC or 
consider functional equivalence for a child. In making these findings, 
we consider the symptoms and signs of DM that the commenters named. We 
also have listings in other body systems for several of the serious 
effects of uncontrolled DM cited in the comment letters. For example, 
we evaluate diabetic nephropathy under our genitourinary listings (6.00 
and 106.00), and peripheral neuropathies under our listings for 
neurological disorders (11.00 and 111.00).
    Nevertheless, in response to these and other comments, we have 
added more guidance in final 9.00B5 and 109.00B5 explaining that DM is 
chronic and that some persons with type 1 and type 2 DM do not achieve 
good control of their disorder for a variety of valid reasons. We also 
indicate that both type 1 and type 2 DM can have serious, disabling 
complications that meet the duration

[[Page 19694]]

requirement. This guidance will apply not only to DKA but also to other 
problems associated with uncontrolled and fluctuating blood glucose 
levels. We did not agree, however, that we should include guidance on 
the complexity of managing and controlling DM and guidance about how DM 
can intrude on the ability to work, which the last commenter 
recommended. We do not believe the recommended guidance is appropriate 
in the context of the listings. The commenter recognized that some of 
the concerns were more appropriate to discussions of RFC and other 
issues associated with later steps of the sequential evaluation 
process.
    We also indicated in the NPRM that we would publish a Social 
Security Ruling (SSR) with more detailed information about specific 
endocrine disorders, including DM, the types of impairments and 
limitations that result from these disorders, and how we determine 
whether persons who have DM and other endocrine disorders are 
disabled.\5\ The SSR will address some of the symptoms and signs of DM 
that are not covered by listings in other body systems.
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    \5\ See 74 FR at 66069.
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    Comment: One commenter said that we did not present crucial 
information and data needed to support our proposal to remove the DM 
listing and, therefore, we should withdraw the proposal. Another 
commenter thought that the references we provided to support our 
proposal to remove the DM listings showed an absence of balance. This 
commenter stated that there is a substantial body of opinion that 
supports the existence of labile or brittle diabetes. To support this 
opinion, this commenter cited as examples two 2007 articles that 
discuss ``brittle'' diabetes.
    Response: We disagree with both commenters. We believe that we 
provided substantial information to support the proposals and that the 
proposals were correct. In the NPRM, we explained that we used 
information from a variety of sources, including:
     Medical experts in the field of endocrinology, experts in 
other related fields, advocacy groups for persons with DM, and persons 
with endocrine disorders and their families;
     Persons 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 listed in the section of 
references at the end of the preamble. We listed 13 references in the 
NPRM, most of which were specifically about DM. We provided Internet 
links for as many of the references as possible and informed the public 
that we would make all of the references available to anyone who was 
interested in seeing them.\6\
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    \6\ 74 FR at 66072.
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    We also explained that we received information from public comments 
that responded to an ANPRM that we published in the Federal Register on 
August 11, 2005.\7\ In the ANPRM, we announced our plans to update and 
revise the listings for the endocrine body system, we invited 
interested persons and organizations to send us written comments and 
suggestions, and we specifically cited our listings for DM. We also 
included citations to references we were considering at that time.\8\ 
In the NPRM, we provided an Internet link where interested members of 
the public could read all of the comments we received in response to 
the ANPRM. We also explained that we received comments and expert input 
at an outreach policy conference we hosted in Atlanta, GA. We provided 
an Internet link to the transcript of that conference that interested 
members of the public could use to read the opinions we received from 
medical professionals, advocates, persons with endocrine disorders and 
their families, and our adjudicators who spoke at the conference.
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    \7\ 70 FR at 46792.
    \8\ Ibid. at 46794.
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    We appreciated the opportunity to consider the articles the second 
commenter cited, but the endocrinologists, diabetologists, and other 
medical experts we consulted and our review of medical literature did 
not support the view that there is ``brittle'' DM. We believe that the 
sources we cited in the NPRM, together with the wide variety of other 
information we also described, represent the prevailing opinion of 
experts in the medical community and provide a balance of opinions.
    Comment: Three commenters thought that we should keep listing 9.08B 
for evaluating recurrent DKA in adults. These commenters noted that 
persons who have repeated episodes of DKA may develop other problems. 
One of these commenters said that we should keep all of prior listing 
9.08.
    Response: We did not adopt the comments. We recognize the serious 
effects of DKA in sections 9.00B5a(i) and 109.00B5b. We explain in 
these final rules that DKA is a potentially life-threatening condition 
resulting from a severe insulin deficiency and that it causes the 
chemical balance of the body to become dangerously hyperglycemic and 
acidic, which usually requires hospital treatment.
    As we explained in the NPRM and in our response to the comments 
above, the criteria in prior listing 9.08B reflected the earlier view 
that persons with wide fluctuations in their blood glucose levels had 
uncontrollable DM. According to the medical experts and relevant 
references we consulted, however, the listing reflected only inadequate 
glucose regulation. Prior listing 9.08B, therefore, included conditions 
that would not be disabling. With respect to keeping all of listing 
9.08, we explained in the NPRM that prior listings 9.08A and C were 
redundant because we have other listings that address the effects they 
cover.\9\ We will evaluate the impairments of persons who have 
difficulty regulating their blood glucose levels for valid reasons on 
an individualized basis.
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    \9\ 74 FR 66070.
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    Comment: Three commenters suggested that we add a listing for 
persons who experience frequent episodes of severe hypoglycemia. They 
pointed out that each episode of hypoglycemia interferes with the 
ability to work while the person is experiencing the episode and that 
frequent severe episodes can effectively make a person unable to 
sustain work, especially since the episodes are unpredictable and would 
affect regular work attendance. Two commenters noted that some persons 
have ``hypoglycemia unawareness''; that is, they lose all or most of 
their ability to detect early warning signs of oncoming hypoglycemia 
and consequently do not take steps to treat the episode when it is 
still early and mild. One commenter suggested listing criteria for 
hypoglycemia based on an average number of documented episodes per 
month despite best efforts to comply with treatment.
    Response: We did not adopt the comments recommending that we add a 
listing for severe hypoglycemia, but we did add a reference to 
hypoglycemia unawareness in final 9.00B5b and 109.00B5c. As with DKA, 
we must make individualized determinations about disability for persons 
who experience frequent episodes. Moreover, as the commenters 
recognized, even severe hypoglycemia episodes can usually be treated 
readily, and most persons who experience hypoglycemia episodes are able 
to adequately recognize and treat their symptoms. We consider the 
effects that frequent episodes of hypoglycemia may have on functioning 
at each step of the sequential evaluation process,

[[Page 19695]]

including the steps regarding the ability to do past relevant work or 
other work. A listing based on an average of documented episodes would 
include some conditions that are not disabling, and accordingly, we did 
not adopt the suggestion.
    Comment: Two commenters requested that we include a listing for 
diabetic neuropathy. One of these commenters noted that sympathetic 
neuropathy, a type of diabetic neuropathy, is difficult to evaluate and 
asked that we not eliminate all listing provisions for evaluating this 
disorder. The other commenter believed that a reference to the 
neurological body system was not enough and that the criteria in 
listing 11.04B were too vague for evaluating diabetic neuropathy. This 
commenter was also concerned that some of our adjudicators might not 
understand that neuropathy caused by DM is different from other types 
of neuropathy and that it does not have to result in amputation to be 
disabling. The commenter suggested that we should have a listing for 
diabetic neuropathy that addresses peripheral, autonomic, proximal, and 
focal neuropathies. In support of their comments, both commenters 
referred to remarks made by a speaker at the outreach policy conference 
in Atlanta. One commenter who cited the speaker's remarks said that 
evaluating a ``diabetic gut'' is a very specialized and difficult 
procedure. The other commenter cited the speaker's statement that a 
person who has not had an amputation can still be disabled by 
peripheral neuropathy. This commenter believed that some adjudicators 
and medical experts consider only amputations.
    Response: The DM listings we are removing did not include a 
provision for sympathetic neuropathy, so these final rules do not 
remove any existing provisions about that medical problem. We also do 
not agree that the speaker's comments at the Atlanta outreach meeting 
support the suggestion that we add a DM listing for neuropathy. We 
reviewed the remarks to which the first commenter referred, and we 
believe that the doctor was referring to what he perceived as 
shortcomings in how we consider neuropathies, including non-diabetic 
neuropathies, in our neurological body system in 11.00 and 111.00 of 
our listings. We will consider those remarks when we revise the 
neurological listings. Moreover, the doctor's remarks discussed the 
variability of the effects of neuropathy on different persons who work 
at different types of jobs, and we believe that his remarks support our 
current policy of considering those effects on a case-by-case basis.
    We also do not agree that adjudicators and medical experts think 
that claimants with diabetic neuropathy must have an amputation before 
we find them disabled. To the contrary, prior listing 9.08A cross-
referred to listing 11.04B, which does not contain a criterion for 
amputation. Rather, that listing requires significant and persistent 
disorganization of motor function in two extremities, so it clearly 
includes persons who have not had amputations. We also provide in 
11.00C that persistent disorganization of motor function may manifest 
as paresis, sensory disturbances, or other causes. These final rules do 
not affect the neurological body system, so current 11.00C and listing 
11.04B will still be applicable to persons with diabetic neuropathy.
    Finally, as one commenter noted, diabetic neuropathy can affect 
different parts of the body. We provide general guidance in final 9.00B 
for evaluating impairments that result from endocrine disorders under 
the listings for other body systems. We provide examples in 9.00B5a(ii) 
regarding evaluation of diabetic peripheral neurovascular disease that 
results in amputation under 1.00, diabetic gastroparesis that results 
in abnormal gastrointestinal motility under 5.00, and diabetic 
peripheral and sensory neuropathies under 11.00. This guidance 
indicates that we are not limited to any specific body system or 
listing in evaluating the complications of DM. We will also address 
diabetic neuropathies in the SSR we are preparing.
    Comment: Four commenters approved of proposed listing 109.08 for 
children who have not attained age 6 and who need daily insulin, but 
asked us to raise the age limit in the listing. Two of these commenters 
stated that the age limit in the proposed listing was too restrictive 
and excluded many children who clearly require constant adult 
supervision. One of these commenters noted that the developmental 
abilities of children vary greatly and that a child who has attained 
age 6 may well have the same medical need for adult help as younger 
children. Another commenter suggested that we change the rule to age 9 
because this is the age at which children generally begin to become 
able to take a significant role in their own care. This commenter 
believed that DM in all children below age 9 will meet the functional 
equivalence example requiring 24-hour-a-day supervision for medical 
reasons, which we cited as one justification for the proposed new 
listing. 20 CFR 416.926a(m)(5). Another commenter recommended that we 
apply the proposed listing to all children under age 18 who have DM and 
require daily insulin. The commenter asserted that many children age 6 
and older lack the cognition to manage their daily insulin regimen 
without the significant involvement of an adult, and many families 
cannot afford the before- and after-school adult care that a child with 
DM may require. Another commenter noted that all children need a 
certain amount of adult supervision in managing DM, especially when 
they are ill.
    Response: Although we did not adopt the comments suggesting that we 
raise the age limit in listing 109.08, we did add further guidance to 
the rule to ensure that adjudicators appropriately consider the effects 
of DM in children age 6 and older. We agree with the commenters that 
children of any age require some level of adult supervision or support 
in caring for their DM. As we explained above, however, we must set 
listings at a level at which we can presume disability in all persons 
whose impairments meet the listing criteria. For the reasons we stated 
in the NPRM, we determined that the attainment of age 6 is the highest 
age at which we could have such a rule.\10\
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    \10\ 74 FR at 66071.
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    We recognize that not all children age 6 and older are capable of 
managing their own DM. In these children, however, the mere need for 
adult supervision does not establish disability; we need to determine 
the nature, frequency, and extent of the supervision they need along 
with any other relevant factors. Final listing 109.08 presumes that 
children under age 6 cannot participate in their own care at the most 
basic level and are at risk of dying unless they have 24-hour-a-day 
adult supervision. Many children age 6 and older with DM that requires 
daily insulin participate in their own care at least at the basic level 
of alerting adults when they begin to experience hypoglycemia symptoms, 
and they often participate at higher levels.
    We agree, however, with the commenters that there are some 
children, including some adolescents, who have a medical need for 24-
hour-a-day supervision; we must evaluate their DM on a more 
individualized basis. We stated in the NPRM that we would find such 
children disabled based on the example of functional equivalence in 
Sec.  416.926a(m)(5). We also said that we expected there would be 
other children who do not need this level of help but who would 
nevertheless have impairments that functionally equal the listings for 
other

[[Page 19696]]

reasons.\11\ We therefore included guidance in proposed (now final) 
section 109.00C explaining that it is possible for a child age 6 or 
older to have the same limitations that we presume for all children 
under age 6; for the same reason we referred to our rules for 
evaluating disability in children in Sec. Sec.  416.924a and 416.926a. 
We nevertheless believe that our statement in the NPRM was correct; as 
children mature, they should be able to increasingly take part in their 
self-care activities related to managing their DM. As a consequence, we 
do not agree that the DM of all children between the ages of 6 and 18 
will meet the functional equivalence example in Sec.  416.926a(m)(5) or 
that they will all be disabled for any other reason. Finally, with 
respect to the comment that many families cannot afford the before- and 
after-school adult care that a child with DM may require, the Act 
requires us to consider only the medical effects of the child's 
impairment; we cannot consider a family's ability to afford care for 
their children.
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    \11\ Ibid.
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    Comment: One commenter asked us to acknowledge in the final rule 
the seriousness and difficulty of managing DM in children. Another 
commenter stated that many children experience significant day-to-day 
variability in their condition, which necessitates daily and often 
hourly decisionmaking and intervention either by an adult or under the 
close supervision of an adult.
    Response: We added language in 109.00B5 and C to clarify these 
issues. We will also address them in more detail in the SSR that we 
will publish after these rules become effective.

Other Comments

    Comment: One commenter suggested that we retain listings for 
complex endocrine disorders, such as diabetes insipidus (DI).
    Response: While it was not clear to us what the commenter meant by 
``complex endocrine disorders,'' we did not adopt the suggestion to 
retain a listing for DI. Generally, medication will control the 
symptoms and signs of DI so they do not reach listing-level severity or 
remain at a sufficient level of severity long enough to meet our 12-
month duration requirement. When DI is not controlled and problems 
ensue, we evaluate the effects in other body systems or on functioning.

Other Changes

    We stated in the NPRM that, if we published the proposed rules as 
final rules, the rules would remain in effect for 8 years after the 
date they become effective, unless we extend them or revise and reissue 
them. In these final rules, we are revising the 8-year sunset date to 5 
years to conform to the timeframes we provide in most of our recent 
listings revisions.\12\ We will monitor these rules and update them 
sooner if necessary.
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    \12\ See for example, ``Revised Medical Criteria for Evaluating 
Hearing Loss,'' 75 FR 30693 (June 2, 2010).
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    We are also making minor editorial changes to correct unintentional 
inconsistencies between 9.00 and 109.00.

What is our authority to make rules and set procedures for determining 
whether a person is disabled under our statutory definition?

    Under the Act, we have full power and authority to make rules and 
regulations and to establish necessary or appropriate procedures to 
carry out such provisions. Sections 205(a), 702(a)(5), and 1631(d)(1).

Regulatory Procedures

Executive Order 12866 as supplemented by Executive Order 13563

    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 as 
supplemented by Executive Order 13563 and were subject to OMB review.

Regulatory Flexibility Act

    We certify that these final rules will not have a 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

    These 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.

(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

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).

Michael J. Astrue,
Commissioner of Social Security.

    For the reasons set out in the preamble, we are amending 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-)

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), 
(i), and (j), 222(c), 223, 225, and 702(a)(5) of the Social Security 
Act (42 U.S.C. 402, 405(a)-(b), and (d)-(h), 416(i), 421(a), (i), 
and (j), 422(c), 423, 425, and 902(a)(5)); sec. 211(b), Pub. L. 104-
193, 110 Stat. 2105, 2189; sec. 202, Pub. L. 108-203, 118 Stat. 509 
(42 U.S.C. 902 note).


0
2. Amend 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. * * *
* * * * *

0
3. Amend appendix 1 to subpart P of part 404 by:
0
a. Revising item 10 of the introductory text before part A;
0
b. Revising the table of contents entry for section 9.00 and section 
9.00 in part A;
0
c. Removing sections 9.01 through 9.08 from part A; and
0
d. Revising the table of contents entry for section 109.00 and 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): June 7, 2016.
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[[Page 19697]]

Part A

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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 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. Both type 1 and type 2 DM are chronic disorders 
that can have serious disabling complications that meet the duration 
requirement. 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. While both type 1 and type 2 DM are usually 
controlled, some persons do not achieve good control for a variety 
of reasons including, but not limited to, hypoglycemia unawareness, 
other disorders that can affect blood glucose levels, inability to 
manage DM due to a mental disorder, or inadequate treatment.
    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 chronic 
hyperglycemia include many conditions affecting various body 
systems.
    (i) Diabetic ketoacidosis (DKA). DKA is an acute, potentially 
life-threatening complication of DM in which the chemical balance of 
the body becomes dangerously hyperglycemic and acidic. It results 
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. Persons 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 glucose; however, some do not 
take this step because of hypoglycemia unawareness. 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.
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Part B

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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 this linear 
growth impairment 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 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

[[Page 19698]]

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. Both type 1 and type 2 DM are chronic disorders 
that can have serious, disabling complications that meet the 
duration requirement. 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. 
Type 2 is less common than type 1 DM in children, but physicians are 
increasingly diagnosing type 2 DM before 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. While both type 1 and type 2 DM are usually controlled, 
some children do not achieve good control for a variety of reasons 
including, but not limited to, hypoglycemia unawareness, other 
disorders that can affect blood glucose levels, inability to manage 
DM due to a mental disorder, or inadequate treatment.
    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 chronic 
hyperglycemia include many conditions affecting various body systems 
but are rare in children.
    b. Diabetic ketoacidosis (DKA). DKA is an acute, potentially 
life-threatening complication of DM in which the chemical balance of 
the body becomes dangerously hyperglycemic and acidic. It results 
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 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; 
however, some do not take this step because of hypoglycemia 
unawareness. 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 follow our rules for determining whether the DM is 
severe, alone or in combination with another impairment, whether it 
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. The 
management of DM in children can be complex and variable from day to 
day, and all children with DM require some level of adult 
supervision. For example, if a child age 6 or older has a medical 
need for 24-hour-a-day adult supervision of insulin treatment, food 
intake, and physical activity to ensure survival, we will find that 
the child's impairment functionally equals the listings based on the 
example in Sec.  416.926a(m)(5).
    D. How do we evaluate other 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, 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.
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PART 416--SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND 
DISABLED

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9. 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 1383b); 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).

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10. 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.

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    (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.
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    (3) In most cases, the specific listings follow the introduction in 
each body system, after the heading, Category of Impairments. * * *
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[FR Doc. 2011-8389 Filed 4-7-11; 8:45 am]
BILLING CODE 4191-02-P