Source: https://www.federalregister.gov/articles/2011/10/25/2011-27357/revised-medical-criteria-for-evaluating-congenital-disorders-that-affect-multiple-body-systems
Timestamp: 2014-03-11 06:55:58
Document Index: 290236077

Matched Legal Cases: ['§ 404', '§ 404', '§ 404', '§ 404', '§ 416', '§ 416', '§ 416', '§ 416']

Federal Register | Revised Medical Criteria for Evaluating Congenital Disorders That Affect Multiple Body Systems
Dates: To ensure that your comments are considered, we must receive them by no later than December 27, 2011.
-66011 (6 pages)
Shorter URL: https://federalregister.gov/a/2011-27357 Related Topics
10.00Congenital Disorders That Affect Multiple Body Systems.
10.00Congenital Disorders That Affect Multiple Body Systems
10.01Category of Impairments, Congenital Disorders That Affect Multiple Body Systems
110.00Congenital Disorders That Affect Multiple Body Systems
We last published final rules making comprehensive revisions to the multiple body systems listings on August 30, 2005.
These listings are scheduled to expire on October 31, 2013. However, we decided to propose these revisions now to reflect our program experience and to address adjudicator questions we have received since 2005.
What revisions are we proposing? Back to Top
We are proposing to change the name of this body system from “Impairments That Affect Multiple Body Systems” to “Congenital Disorders That Affect Multiple Body Systems” to clarify that we consider only certain congenital disorders in this body system. We evaluate other disorders that affect more than one body system under the listings that address their specific effects. We evaluate congenital disorders with single effects under other body systems.
What changes are we proposing to the introductory text of the multiple body systems adult listings? Back to Top
10.00A What Impairment Do We Evaluate Under This Body System?
10.00A Which disorder do we evaluate under this body system?
10.00A1 General.
Revised and included in 10.00A.
10.00A2 What is Down syndrome?
Revised and included in 10.00B.
10.00A3 What is non-mosaic Down syndrome?
10.00B What is non-mosaic Down syndrome?
10.00A4 What is mosaic Down syndrome?
Revised and included in 10.00B and 10.00D.
10.00B What Documentation Do We Need To Establish That You Have Non-Mosaic Down Syndrome?
10.00C What evidence do we need to document non-mosaic Down syndrome under 10.06?
10.00B1 General.
Revised and included in 10.00C.
10.00B2 Definitive chromosomal analysis.
10.00B3 What if we do not have the results of definitive chromosomal analysis?
10.00C How Do We Evaluate Other Impairments That Affect Multiple Body Systems?
10.00D How do we evaluate mosaic Down syndrome and other congenital disorders that affect multiple body systems?
10.00D1 Mosaic Down syndrome.
10.00D2 Other congenital disorders that affect multiple body systems.
10.00D3 Evaluating the effects of mosaic Down syndrome or another congenital disorder under the listing.
10.00E What if your disorder does not meet a listing?
In proposed section 10.00B, we describe non-mosaic Down syndrome and its effects. We propose to replace the term “mental retardation” with the term “intellectual disability” to conform with recent legislation that revised certain Federal statutes that referred to “mental retardation” to use the term “intellectual disability” instead.
In proposed section 10.00C1, we explain that we need a copy of a laboratory report of karyotype analysis to establish that a claimant's non-mosaic Down syndrome meets proposed listing 10.06A. Karyotype analysis clarifies whether the Down syndrome is the non-mosaic or mosaic form. The report must either be signed by a physician or, if unsigned, accompanied by a statement from a physician indicating that the person has Down syndrome.
Our rules require evidence from an “acceptable medical source” to establish the existence of a medically determinable impairment, and a physician is the only acceptable source for establishing that a person has Down syndrome.
The physician does not need to provide any additional information to establish the existence of the disorder, as we explain in proposed section 10.00C1c.
In proposed section 10.00C2b, we explain a new method for establishing disability based on non-mosaic Down syndrome under proposed listing 10.06C. The proposed listing, which is also based on our adjudicative experience, allows for a finding of disability when the claimant has not had definitive laboratory testing or we have no information about karyotype analysis results even if the person did have a test. Because we do not have definitive test results, we would require a more detailed description of the clinical features of the disorder and evidence that the claimant's functioning is consistent with a diagnosis of non-mosaic Down syndrome. The proposed provision would allow us to find that a claimant does not have non-mosaic Down syndrome if we have other evidence that is inconsistent with a diagnosis of the disorder. This provision is similar to current 10.00B3 that provides “the report must be consistent with other evidence in your case record.” While we do not need to obtain additional evidence, we must consider any other evidence in the case record to ensure that it is consistent with the diagnosis.
What changes are we proposing to the multiple body systems listings for adults? Back to Top
What changes are we proposing to the introductory text of the congenital disorders listings for children? Back to Top
110.00A What Kinds of Impairments Do We Evaluate Under This Body System?
110.00A Which disorders do we evaluate under this body system?
110.00A1 General.
Revised and included in 110.00A.
110.00A2 What is Down syndrome?
Revised and included in 110.00B.
110.00A3 What is non-mosaic Down syndrome?
110.00B What is non-mosaic Down syndrome?
110.00A4 What is mosaic Down syndrome?
Revised and included in 110.00F.
110.00A5 What are catastrophic congenital abnormalities or diseases?
Revised and included in 110.00D.
110.00B What Documentation Do We Need To Establish That You Have an Impairment That Affects Multiple Body Systems?
110.00C What evidence do we need to document non-mosaic Down syndrome under 110.06?
110.00B1 General.
Revised and included in 110.00C.
110.00B2 Non-mosaic Down syndrome (110.06)
110.00B3 Catastrophic congenital abnormalities or diseases (110.08)
Revised and included in 110.00D and 110.00E.
110.00D What are catastrophic congenital disorders?
110.00E What evidence do we need under 110.08?
110.00C How Do We Evaluate Other Impairments That Affect Multiple Body Systems and That Do Not Meet the Criteria of the Listings in This Body System?
110.00F How do we evaluate mosaic Down syndrome and other congenital disorders that affect multiple body systems?
110.00F1 Mosaic Down syndrome.
110.00F2 Other congenital disorders that affect multiple body systems.
110.00F3 Evaluating the effects of mosaic Down syndrome or another congenital disorder under the listings.
110.00G What if your disorder does not meet a listing?
Proposed section 110.00E corresponds to current section 110.00B3. We propose changes in this section to make it similar to proposed sections 10.00C and 110.00C for non-mosaic Down syndrome. For example, the current rule requires both a clinical description of the diagnostic physical features of the disorder and the report of the definitive laboratory study establishing the diagnosis. Since the second requirement is for a definitive laboratory study, we do not believe that we also need a description of the diagnostic clinical features in such cases. We believe that we can simplify the rule and make some favorable determinations more quickly. What changes are we proposing to the congenital disorders listings for children? Back to Top
We propose to revise current listing 110.06, Non-mosaic Down syndrome, in the same way as proposed adult listing 10.06. We would revise listings 110.08A and B by moving the examples from these current listings to proposed section 110.00D in the introductory text. We would also replace the phrase “profoundly impaired” in listing 110.08A with the phrase “very serious interference” the same phrase we use in proposed listing 110.08B. Both listings should have the same severity criterion. The criterion we propose is based on current listing 110.08B, which uses the phrase “interferes very seriously” and is a term we use in other rules. We would also clarify in proposed section 110.00D that “very seriously” has the same meaning as our definition of the term “extreme” in our rules for determining functional equivalence for children.
10.00Congenital Disorders That Affect Multiple Body Systems. Back to Top
10.00Congenital Disorders That Affect Multiple Body Systems Back to Top
B. What is non-mosaic Down syndrome? Non-mosaic Down syndrome is a genetic disorder. Most people with non-mosaic Down syndrome have three copies of chromosome 21 in all of their cells (chromosome 21 trisomy); some have an extra copy of chromosome 21 attached to a different chromosome in all of their cells (chromosome 21 translocation). Virtually all people with non-mosaic Down syndrome have characteristic facial or other physical features, delayed physical development, and intellectual disability. People with non-mosaic Down syndrome may also have congenital heart disease, impaired vision, hearing problems, and other disorders. We evaluate non-mosaic Down syndrome under 10.06. If you have non-mosaic Down syndrome documented as described in 10.00C, we consider you disabled from birth. C. What evidence do we need to document non-mosaic Down syndrome under 10.06?
b. If a physician (see §§ 404.1513(a)(1) and 416.913(a)(1) of this chapter) has not signed the laboratory report of karyotype analysis, the evidence must also include a physician's statement that you have Down syndrome.
E. What if your disorder does not meet a listing? If you have a severe medically determinable impairment(s) that does not meet a listing, we will consider whether your impairment(s) medically equals a listing. See §§ 404.1526 and 416.926 of this chapter. If your impairment(s) does not meet or medically equal a listing, you may or may not have the residual functional capacity to engage in substantial gainful activity. We proceed to the fourth, and if necessary, the fifth steps of the sequential evaluation process in §§ 404.1520 and 416.920 of this chapter. We use the rules in §§ 404.1594 and 416.994 of this chapter, as appropriate, when we decide whether you continue to be disabled.
10.01Category of Impairments, Congenital Disorders That Affect Multiple Body Systems Back to Top
110.00Congenital Disorders That Affect Multiple Body Systems Back to Top
D. What are catastrophic congenital disorders? Some catastrophic congenital disorders, such as anencephaly, cyclopia, chromosome 13 trisomy (Patau syndrome or trisomy D), and chromosome 18 trisomy (Edwards' syndrome or trisomy E) are usually expected to result in early death. Others such as cri du chat syndrome (chromosome 5p deletion syndrome) and the infantile onset form of Tay-Sachs disease interfere very seriously with development. We evaluate catastrophic congenital disorders under 110.08. The term “very seriously” in 110.08 has the same meaning as in the term “extreme” in § 416.926a(e)(3) of this chapter.
G. What if your disorder does not meet a listing? If you have a severe medically determinable impairment(s) that does not meet a listing, we will consider whether your impairment(s) medically equals a listing. See § 416.926 of this chapter. If your impairment(s) does not meet or medically equal a listing, we will consider whether it functionally equals the listings. See §§ 416.924a and 416.926a of this chapter. We use the rules in § 416.994a of this chapter when we decide whether you continue to be disabled.
110.01Category of Impairments, Congenital Disorders That Affect Multiple Body Systems Back to Top
1. 70 FR 51252.
2. We published an advance notice of proposed rulemaking (ANPRM) on November 10, 2009. 74 FR 57971. In the ANPRM, we invited interested people and organizations to send us written comments and suggestions about whether and how we should revise these listings. We received two comment letters. We said in the ANPRM that we would not respond to the comment letters, and this NPRM does not reflect the commenters' suggestions. You may read the comment letters at http://www.regulations.gov by searching under docket number SSA-2009-0039.
3. Rosa's Law, Pub. L. 111-256 (Oct. 5, 2010). It also revised references from “a mentally retarded individual” to “an individual with an intellectual disability.”
4. We define the terms “medically determinable impairment” and “acceptable medical source” in 20 CFR 404.1508, 404.1513, 416.908, and 416.913.
5. See 20 CFR 416.926a(e)(3).