Revised Medical Criteria for Evaluating Endocrine Disorders

AGENCY:

Social Security Administration.

ACTION:

Notice of proposed rulemaking.

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.

Why are we proposing these revisions?

We last published final rules making comprehensive revisions to the 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.

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. For example, DM can lead to:

• 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. 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.

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 disorders and the impairments they may cause. We are not providing any specific listing criteria.

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). 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.

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.

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)

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).

2. Amend § 404.1525 by revising paragraph (c)(1) and the first sentence of paragraph (c)(3) to read as follows:

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 § 416.925 by revising paragraph (c)(1) and the first sentence of paragraph (c)(3) to read as follows: