Revised Medical Criteria for Evaluating Neurological Disorders, 43048-43061 [2016-15306]

Download as PDF 43048 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations and attaching Inline XBRL documents to EDGAR submissions are described in a new subsection 5.2.5 of EDGAR Filer Manual, Volume II. Along with the adoption of the Filer Manual, we are amending Rule 301 of Regulation S–T to provide for the incorporation by reference into the Code of Federal Regulations of today’s revisions. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The updated EDGAR Filer Manual will be available for Web site viewing and printing; the address for the Filer Manual is http://www.sec.gov/info/ edgar.shtml. You may also obtain paper copies of the EDGAR Filer Manual from the following address: Public Reference Room, U.S. Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. Since the Filer Manual and the corresponding rule changes relate solely to agency procedures or practice, publication for notice and comment is not required under the Administrative Procedure Act (APA).4 It follows that the requirements of the Regulatory Flexibility Act 5 do not apply. The effective date for the updated Filer Manual and the rule amendments is July 1, 2016. In accordance with the APA,6 we find that there is good cause to establish an effective date less than 30 days after publication of these rules. The EDGAR system upgrade to Release 16.2 is scheduled to become available on June 13, 2016. The Commission believes that establishing an effective date less than 30 days after publication of these rules is necessary to coordinate the effectiveness of the updated Filer Manual with these system upgrades. asabaliauskas on DSK3SPTVN1PROD with RULES Statutory Basis We are adopting the amendments to Regulation S–T under Sections 6, 7, 8, 10, and 19(a) of the Securities Act of 1933,7 Sections 3, 12, 13, 14, 15, 23, and 35A of the Securities Exchange Act of 1934,8 Section 319 of the Trust Indenture Act of 1939,9 and Sections 8, 30, 31, and 38 of the Investment Company Act of 1940.10 45 U.S.C. 553(b). U.S.C. 601–612. 6 5 U.S.C. 553(d)(3). 7 15 U.S.C. 77f, 77g, 77h, 77j, and 77s(a). 8 15 U.S.C. 78c, 78l, 78m, 78n, 78o, 78w, and 78ll. 9 15 U.S.C. 77sss. 10 15 U.S.C. 80a–8, 80a–29, 80a–30, and 80a–37. 55 VerDate Sep<11>2014 16:44 Jun 30, 2016 Jkt 238001 List of Subjects in 17 CFR Part 232 Incorporation by reference, Reporting and recordkeeping requirements, Securities. Text of the Amendment In accordance with the foregoing, title 17, chapter II of the Code of Federal Regulations is amended as follows: PART 232—REGULATION S–T— GENERAL RULES AND REGULATIONS FOR ELECTRONIC FILINGS availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federal_register/ code_of_federal_regulations/ibr_ locations.html. By the Commission. Dated: June 13, 2016. Brent J. Fields, Secretary. [FR Doc. 2016–15510 Filed 6–30–16; 8:45 am] BILLING CODE 8011–01–P ■ 1. The authority citation for part 232 continues to read in part as follows: SOCIAL SECURITY ADMINISTRATION Authority: 15 U.S.C. 77f, 77g, 77h, 77j, 77s(a), 77z–3, 77sss(a), 78c(b), 78l, 78m, 78n, 78o(d), 78w(a), 78ll, 80a–6(c), 80a–8, 80a–29, 80a–30, 80a–37, and 7201 et seq.; and 18 U.S.C. 1350, unless otherwise noted. 20 CFR Part 404 * * * * * 2. Section 232.301 is revised to read as follows: Revised Medical Criteria for Evaluating Neurological Disorders § 232.301 ACTION: ■ EDGAR Filer Manual. Filers must prepare electronic filings in the manner prescribed by the EDGAR Filer Manual, promulgated by the Commission, which sets out the technical formatting requirements for electronic submissions. The requirements for becoming an EDGAR Filer and updating company data are set forth in the updated EDGAR Filer Manual, Volume I: ‘‘General Information,’’ Version 24 (December 2015). The requirements for filing on EDGAR are set forth in the updated EDGAR Filer Manual, Volume II: ‘‘EDGAR Filing,’’ Version 37 (June 2016). Additional provisions applicable to Form N–SAR filers are set forth in the EDGAR Filer Manual, Volume III: ‘‘N– SAR Supplement,’’ Version 5 (September 2015). All of these provisions have been incorporated by reference into the Code of Federal Regulations, which action was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You must comply with these requirements in order for documents to be timely received and accepted. The EDGAR Filer Manual is available for Web site viewing and printing; the address for the Filer Manual is http://www.sec.gov/info/ edgar.shtml. You can obtain paper copies of the EDGAR Filer Manual from the following address: Public Reference Room, U.S. Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. You can also inspect the document at the National Archives and Records Administration (NARA). For information on the PO 00000 Frm 00066 Fmt 4700 Sfmt 4700 [Docket No. SSA–2006–0140] RIN 0960–AF35 Social Security Administration. Final rule. AGENCY: We are revising the criteria in the Listing of Impairments (listings) that we use to evaluate disability claims involving neurological disorders in adults and children under titles II and XVI of the Social Security Act (Act). These revisions reflect our program experience; advances in medical knowledge, treatment, and methods of evaluating neurological disorders; comments we received from medical experts and the public at an outreach policy conference; responses to an advance notice of proposed rulemaking (ANPRM); and public comments we received in response to a Notice of Proposed Rulemaking (NPRM) and a Federal Register notice that reopened the NPRM comment period. DATES: This rule is effective September 29, 2016. FOR FURTHER INFORMATION CONTACT: Cheryl A. Williams, Office of Disability Policy, 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. SUMMARY: SUPPLEMENTARY INFORMATION: Background We are making final the rule for evaluating neurological disorders that we proposed in an NPRM published in the Federal Register on February 25, 2014 (79 FR 10636). In the preamble to the NPRM, we discussed the revisions to our current rule for the neurological E:\FR\FM\01JYR1.SGM 01JYR1 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations body system and our reasons for proposing those revisions. To the extent that we are adopting the proposed rule as published, we are not repeating that information here; interested readers may refer to the NPRM preamble. We incorporated into the final rule the portions of Social Security Ruling (SSR) 87–6, ‘‘Titles II and XVI: The Role of Prescribed Treatment in the Evaluation of Epilepsy’’ that continue to be relevant to the treatment of epilepsy. As part of the publication of this final rule, we are rescinding SSR 87–6. We also respond to public comments on the NPRM and explain what changes we are making based on those comments in the ‘‘Public Comments on the NPRM’’ section of the preamble. Why are we revising the listings for evaluating neurological disorders? We are comprehensively revising the listings for evaluating neurological disorders to update the medical criteria, provide additional methods of evaluating neurological disorders, provide more information on how we evaluate neurological disorders, make other changes that reflect our program experience, and address adjudicator questions. We last comprehensively revised the listings for the neurological disorders body system in a final rule published on December 6, 1985.1 We have made only a few changes since then to meet program purposes.2 Summary of Public Comments on the NPRM In the NPRM, we provided the public with a 60-day comment period that ended on April 28, 2014. We reopened the comment period for 30 days on May 1, 2014 (70 FR 24634). The last of the two comment periods closed on June 2, 2014. We received and posted 2,103 public comments during the initial period for public comments on the NPRM, and received and posted an additional 921 when we extended the NPRM comment period. We also received and posted 55 comments when we initially made the public aware of our efforts to update this rule, when we 1 50 FR 50068. December 12, 1990, we raised the IQ limit in 11.07A, 111.02B1, 111.07B1, and 111.08B2 from 69 to 70 (55 FR 51204). We published a final rule adding section 11.00F for traumatic brain injury on August 21, 2000 (65 FR 50746); made technical revisions to most of the body systems on April 24, 2002 (67 FR 20018), which included some changes to the neurological body system; revised listing 11.10 for Amyotrophic lateral sclerosis (ALS) on August 82, 2003 (68 FR 51689); moved the listings for malignant brain tumors to the body system for malignant neoplastic diseases on November 15, 2004 (69 FR 67018); and made a technical correction in listing 111.09 on March 24, 2011 (76 FR 16531). asabaliauskas on DSK3SPTVN1PROD with RULES 2 On VerDate Sep<11>2014 16:44 Jun 30, 2016 Jkt 238001 published the ANPRM. The comments came from members of the public, medical professionals, national medical organizations, advocacy groups, disability examiners and other adjudicators, and a national association representing disability examiners in the State agencies that make disability determinations for us. The majority of the comments was repetitive and expressed support of or agreement with identical recommendations submitted by a few national organizations. For example, we received just over 1,100 comments that repeated, or were in support of recommendations submitted by a few Huntington’s disease organizations; approximately 800 comments that repeated, or were in support of recommendations submitted by various headache organizations; and approximately 350 repeat comments that were in support of recommendations from various Parkinson’s disease organizations. In general, the recommendations and concerns raised by the majority of public commenters were very similar or identical. We received several comments suggesting that we create separate listings for various neurological disorders that we address in one comment below. Some commenters noted provisions with which they agreed and did not make suggestions for changes in those provisions. For example, over 300 comments were testimonials from commenters sharing their personal experience with various neurological disorders. Approximately 300 comments were outside the scope of the neurological NPRM, several of those were relevant to other body system disorders; we shared those comments with the appropriate body systems policy teams for consideration. We did not summarize or respond to comments that were in agreement with, or outside the scope of the neurological NPRM. We addressed repetitive comments that raised identical issues as one comment. We carefully considered all of the relevant comments we received and we responded to all of the significant issues raised by the commenters that were within the scope of this rule. We provide our reasons for adopting or not adopting the comment recommendations in our responses below. General Comments Comment: Several commenters suggested that we create separate listings for various neurological disorders, such as migraine, cluster headaches and other severe headache disorders, fetal alcohol syndrome, PO 00000 Frm 00067 Fmt 4700 Sfmt 4700 43049 cervical dystonias, atypical facial pain, and trigeminal neuralgia. One commenter expressed opposition to creating a separate listing for migraine headaches because the symptoms are too subjective. Other commenters suggested adding several neurological disorders to specific listings. Response: We did not adopt these comments. While we do not have listings for every neurological condition, we are able to evaluate unlisted neurological disorders in several ways under our sequential evaluation process. We will determine whether your impairment medically equals a listing. If your impairment does not medically equal the criteria of a listing, you may or may not have the residual functional capacity to perform your past relevant work or adjust to other work that exists in significant numbers in the national economy, which we determine at the fourth and, if necessary, the fifth steps of the sequential evaluation process. As we work on the next iteration of revisions to the neurological rule, we will consider the suggestions for adding new listings and will consider comments expressing opposition to adding certain new listings. Comment: We received a number of comments related to how we evaluate migraines and other chronic headache disorders. As we mentioned in the previous comment, several commenters asked that we recognize migraines as a disabling impairment and suggested we create a specific listing. Other commenters suggested listing criteria for us to consider. One commenter raised concerns about evaluating chronic headache disorders because of the subjective nature of the disorders. Response: We acknowledge the commenters’ concerns. We realize it is appropriate to provide impairmentspecific guidance on how we evaluate migraines and other chronic headache disorders. We will address these concerns in training to ensure all adjudicators know how to establish migraine and other chronic headache disorders as medically determinable impairments (MDIs). Once we establish the existence of an MDI(s), we follow the remaining steps in the sequential evaluation process (See §§ 404.1520, 416.920, and 416.924). As noted in the response above to the comments about creating additional listings, we are able to evaluate unlisted neurological disorders in several ways under our sequential evaluation process. Comment: We received several comments expressing concern that the proposed functional criteria for determining disability in individuals with Huntington’s disease (HD) and E:\FR\FM\01JYR1.SGM 01JYR1 asabaliauskas on DSK3SPTVN1PROD with RULES 43050 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations Parkinson’s disease still rely on the presence of physical limitations and do not adequately address the common non-physical manifestations of these diseases. The commenters suggested we include the mental criteria from the mental body system in the neurological disorders body system to evaluate the mental aspects of neurological disorders in the absence of physical limitations commonly seen in HD and in Parkinson’s disease. They indicated the proposed criteria should include criteria specific to mental functioning in order to address the full range of symptoms often experienced by people who suffer with HD and Parkinson’s disease. The commenters also suggested that the proposed introductory text sections where we discuss HD and Parkinson’s disease direct adjudicators beyond listing 12.02 to expand to the entire mental body system, as appropriate, when they need to evaluate mental symptoms associated with neurological disorders. Response: We partially adopted this comment. For program purposes, we consider all impairments under all applicable body systems as part of our disability evaluation. In the listings, we describe each of the major body systems impairments we consider severe enough to be disabling, and we list requirements that demonstrate a level of severity and duration consistent with the definition of disability set by Congress under the Act. We evaluate the person’s impairment(s) under the most appropriate body system(s). We recognize that neurological disorders may co-occur with impairments we evaluate in other body systems; however, we intend the listings in this final rule to address only neurological disorders and the complications from those disorders. When only mental aspects of neurological disorders are present in the absence of physical limitations commonly seen in HD and Parkinson’s disease, we evaluate those limitations under the appropriate mental disorders body system listings. However, when mental aspects of neurological disorders are present and co-occur with the physical limitations of these disorders, we evaluate limitations in physical and mental functioning under the neurological listings. In response to this and similar comments, we provided additional guidance in the introductory text explaining how we evaluate mental disorders under these listings. We modified our functional criteria and severity rating scale to address the common mental aspects of neurological disorders. Our intent in the new functional criteria for adults is to VerDate Sep<11>2014 16:44 Jun 30, 2016 Jkt 238001 provide a way to evaluate impairments and determine disability appropriately, even when those impairments are difficult to evaluate based on medical criteria alone. With functional criteria, we can evaluate the functional impact associated with any neurological impairment in broad areas of physical and mental functioning. The four areas of mental functioning are understanding, remembering, or applying information; interacting with others; concentrating, persisting, or maintaining pace; and adapting or managing oneself. For example, a person with a neurological disorder may demonstrate a limitation in the ability to walk (as addressed under the physical functioning criterion). He or she may also have a mental impairment resulting from the neurological disorder, which is demonstrated by a limitation in the ability to concentrate. Comment: A commenter stated that the definition of social functioning in proposed section 11.00G3 should not focus solely on limitations caused by physical ailments. The commenter suggested that the social functioning criteria should include interpersonal interactions, as well as non-physical symptoms such as irritability, aggression, and perseveration. Response: We adopted this comment. We mentioned in the previous comment we modified our functional criteria to focus on the common mental aspects of neurological disorders. We also changed the criterion from ‘‘social functioning’’ to ‘‘interacting with others’’ to be consistent with the way mental functions are described in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.3 Comment: Several commenters noted that proposed section 11.00C states, ‘‘Medical research shows that these neurological conditions may improve after a period of treatment.’’ The commenters pointed out this statement is false and we should correct it because Parkinson’s disease never improves. Response: We adopted this comment. It was not our intent to indicate in listing 11.06 that Parkinson’s disease itself may improve with treatment, as the disease is progressive. We removed the statement. Comment: Several commenters asked that we revise proposed section 11.00K to clarify that motor and non-motor symptoms can be equally disabling in Parkinsonian syndromes, and to reflect that symptoms can fluctuate 3 American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Arlington, VA, American Psychiatric Association, 2013. PO 00000 Frm 00068 Fmt 4700 Sfmt 4700 significantly from hour to hour and minute to minute, often making job performance in a professional environment very difficult. Response: We partially adopted this comment. We agree that non-motor symptoms can be as disabling as motor symptoms in Parkinsonian syndromes. However, limitations resulting from non-motor symptoms are highly variable and we evaluate them on a case-by-case basis. The new functional criteria enable adjudicators to evaluate non-motor symptoms associated with Parkinsonian syndromes under listing 11.06B. We mention that neurological disorders may manifest in a combination of limitations in physical and mental functioning in the adult section, 11.00G. We will also provide guidance in training to adjudicators about the variable manifestations of neurological disorders, such as Parkinsonian syndrome. Comment: One commenter expressed disappointment that the revised epilepsy listing does not include any discussion of how to ‘‘deal with claimants who suffer from a mix of tonic-clonic and dyscognitive seizures.’’ The commenter stated that ‘‘although the revised listing explicitly acknowledges that individuals may suffer from a mix of tonic-clonic and dyscognitive seizures,4 there is no guidance as to how to evaluate a claimant experiencing both types of seizures.’’ Response: We do not agree with the commenter. In section 11.00H4c, we provide guidance on how to count dyscognitive seizures that progress into generalized tonic-clonic seizures. However, we do not believe that it is possible to address every permutation of the dyscognitive and tonic-clonic mixed seizure types. The signs and symptoms of such seizure types will vary from person to person. Adjudicators evaluate limitations caused by mixed seizures on a case-by-case basis. Comment: One commenter was pleased that we included a more detailed explanation for the term ‘‘marked’’ in 11.00G2 but was concerned that this definition relied on the term ‘‘seriously,’’ as in ‘‘interfere seriously’’ and ‘‘seriously limit,’’ which we did not define. This commenter believed that not defining the term ‘‘seriously,’’ while repeatedly relying on it to define the term ‘‘marked,’’ creates a significant ambiguity in the listings. The commenter was concerned that adjudicators will apply the term ‘‘marked’’ inconsistently unless we 4 See E:\FR\FM\01JYR1.SGM NPRM 11.00H(4)(c). 01JYR1 asabaliauskas on DSK3SPTVN1PROD with RULES Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations include a definition for the term ‘‘seriously.’’ Response: We partially adopted this comment. In the modified final section 11.00D of the introductory text, we include criteria for how to establish disorganization of motor function, descriptions for how to evaluate those criteria, and a definition of an extreme limitation in disorganization of motor function. If we do not find that a person is disabled on the basis of disorganization of motor function alone, as explained in 11.00D, we will find that the person’s neurological disorder is incompatible with the ability to do any gainful activity if it results in marked limitation in physical functioning and marked limitation in one of four areas of mental functioning. In the modified final section 11.00G of the introductory text, we provide definitions for marked limitations drawn from our currently used definitions in section 7.00G4 of the listing of impairments for hematological disorders and section 1.00B of the listing of impairments for musculoskeletal disorders. We also provide descriptions of the considerations for physical and mental functioning in 11.00G2 and 11.00G3. Comment: One commenter suggested that we not remove the intelligence quotient (IQ) requirement from the neurological listings, as the commenter believes it is the best indicator of mental capability. Response: We did not adopt this comment. As we explained in the preamble to the NPRM, we are removing the criterion of an IQ score from our neurological listings because advances in medical knowledge of cerebral palsy (for adults and children), epilepsy (for children), spinal cord insults (for children), and our program experience indicate that an IQ score does not provide the best measure of limitations in cognitive functioning associated with these disorders. Therefore, it may not indicate listing-level severity under the neurological listings and would be more appropriately used to evaluate mental disorders under our mental disorders body system. Comment: One commenter expressed that scales rating function into categories such as ‘‘mild,’’ ‘‘moderate,’’ and ‘‘severe,’’ are clearly subjective on the part of the rater and their meaningfulness is questionable. Response: The word ‘‘severe’’ in the disability program separates step 2 from step 3 in the sequential evaluation process that we use to evaluate a person’s physical or mental impairment or combination of impairments. If we find at step 2 that a person does not VerDate Sep<11>2014 16:44 Jun 30, 2016 Jkt 238001 have a ‘‘severe’’ medically determinable impairment (MDI) or combination of MDIs that meet the duration requirement, we will find the person is not disabled. If we find at step 2 that the person has a ‘‘severe’’ MDI or combination of MDIs, we will continue evaluating the impairment(s) at step 3 of the sequential evaluation process. (See §§ 404.1520(a), 416.920(a) and 416.924(a).) With respect to the terms, ‘‘mild’’ and ‘‘moderate,’’ we have used those terms in a five-point rating scale in the mental disorders body system (consisting of none, mild, moderate, marked, and extreme) since 1985 (§§ 404.1520a and 416.920a). We have also used the terms ‘‘marked’’ and ‘‘extreme’’ limitation in childhood functional equivalence policy (§§ 416.926a). Such scales and ratings continue to be standard medical practice, and continue to be effective for evaluating degrees of impairmentrelated limitation(s). Moreover, in the modified final introductory text (11.00D2, 11.00G2, and 11.02D2), we include guidance for our adjudicators on the meaning and use of these terms. Comment: One commenter said a significant feature of the proposed new criteria is that we will presume individuals (with many different neurological disorders) are disabled if they are unable to stand from a sitting position and are not presently working. The commenter noted that it appears obvious from casual observation that many individuals successfully work in a wide variety of different sedentary positions, such as Wal-Mart greeter, office worker, and physician. Because significant numbers of these individuals work on a regular basis in the national economy, it is quite easy for a lay observer to think it inappropriate for the Social Security Administration to presume that all individuals unable to stand are also unable to work. Response: We did not adopt this comment. As we explain in 11.00D2a, an inability to stand up from a seated position means that, once seated, you are unable to stand and maintain an upright position without the risk of falling unless you have the assistance of another person or the use of an assistive device, such as a walker, two crutches, or two canes. The severity of such a limitation is set at a standard much higher than that applicable to a person who is able to do sedentary work; it thereby constitutes an inability to do any gainful activity in the national economy. Comment: One commenter suggested that when referring to spinal cord insults we use the term ‘‘spinal cord PO 00000 Frm 00069 Fmt 4700 Sfmt 4700 43051 disorders’’ instead of ‘‘spinal cord insults.’’ Response: We agree with the commenter and adopted this comment. Comment: Some commenters asked how we would evaluate adherence to prescribed treatment for epilepsy patients when we removed the requirement for serum drug levels, particularly for patients prescribed newer antiepileptic drugs. Response: We describe how we consider adherence to prescribed treatment under 11.00C. We consider whether you have taken medications or followed other treatment procedures as prescribed by a physician for three consecutive months. We no longer require serum drug levels. When we last revised the listings in 1985, blood drug levels were strong indicators for prescribed treatment compliance because therapeutic ranges had been established for antiepileptic drugs (AEDs) and the ranges were often noted on laboratory results. Many newer AEDs do not have established therapeutic levels, which makes lab results difficult for our adjudicators to interpret. We removed the requirement for obtaining blood drug levels to address this adjudicative issue and to simplify evaluation of seizures that satisfy the listing criteria. However, we will continue to consider blood drug levels available in the evidence in the context of all evidence in the case record. What is our authority to make rules and set procedures for determining whether a person is disabled under the statutory definition? The Act authorizes us to make rules and regulations and to establish necessary and appropriate procedures to implement them.5 When will we begin to use this final rule? We will begin to use this final rule on its effective date. We will continue to use the current listings until the date the final rule becomes effective. We will apply the final rule to new applications filed on or after the effective date of the final rule and to claims that are pending on or after the effective date.6 5 42 U.S.C. 405(a), 902(a)(5), and 1383(d)(1). means that we will use the final rule on and after their effective date in any case in which we make a determination or decision. We expect that Federal courts will review the Commissioner’s final decisions using the rule that were in effect at the time we issued the decisions. If a court reverses the Commissioner’s final decision and remands a case for further administrative proceedings after the effective date of the final rule, we will apply the final rule to the entire period at issue in the decision we make after the court’s remand. 6 This E:\FR\FM\01JYR1.SGM 01JYR1 43052 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations How long will this final rule be effective? This final rule will remain in effect for 5 years after the date it becomes effective, unless we extend it, or revise and issue it again. Regulatory Procedures Executive Order 12866, as Supplemented by Executive Order 13563 We consulted with the Office of Management and Budget (OMB) and determined that this final rule meets the criteria for a significant regulatory action under Executive Order 12866, as supplemented by Executive Order 13563. Therefore, OMB reviewed it. Regulatory Flexibility Act We certify that this final rule will not have a significant economic impact on a substantial number of small entities because it affects only individuals. Therefore, the Regulatory Flexibility Act, as amended, does not require us to prepare a regulatory flexibility analysis. Paperwork Reduction Act These rules do not create any new or affect any existing collections and, therefore, do not require OMB approval under the Paperwork Reduction Act. Carolyn W. Colvin, Acting Commissioner of Social Security. For the reasons set out in the preamble, we are amending 20 CFR part 404, subpart P as set forth below: PART 404—FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950–) Subpart P—Determining Disability and Blindness 1. The authority citation for subpart P of part 404 continues to read as follows: asabaliauskas on DSK3SPTVN1PROD with RULES ■ 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). Jkt 238001 * * * * * 12. Neurological Disorders (11.00 and 111.00): September 29, 2021. * * * * * * * * Part A * * 11.00 * * * List of Subjects in 20 CFR Part 404 Administrative practice and procedure, Blind, Disability benefits, Old-age, Survivors, and Disability Insurance, Reporting and recordkeeping requirements, Social Security. 16:44 Jun 30, 2016 APPENDIX 1 TO SUBPART P OF PART 404—LISTING OF IMPAIRMENTS 1.00 (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). VerDate Sep<11>2014 2. Amend appendix 1 to subpart P of part 404 as follows: ■ a. Revise item 12 of the introductory text before part A; ■ b. Amend part A by revising the body system name for section 11.00 in the table of contents; ■ c. In section 1.00 of part A, revise the introduction to paragraph K; ■ d. Revise section 11.00 of part A; ■ e. In section 12.00 of part A, revise paragraph D10, listing 12.01, listing 12.09E, and listing 12.09I; ■ f. Amend part B by revising the body system name for section 111.00 in the table of contents; ■ g. In section 101.00 of part B, revise the last sentence of paragraph B1; ■ h. In section 101.00 of part B, revise the last sentence of paragraph B1 and paragraph K; and ■ i. Revise section 111.00 of part B to read as follows: ■ * Neurological Disorders * * * Musculoskeletal System * * * K. Disorders of the spine, listed in 1.04, result in limitations because of distortion of the bony and ligamentous architecture of the spine and associated impingement on nerve roots (including the cauda equina) or spinal cord. Such impingement on nerve tissue may result from a herniated nucleus pulposus, spinal stenosis, arachnoiditis, or other miscellaneous conditions. * * * * * 11.00 NEUROLOGICAL DISORDERS A. Which neurological disorders do we evaluate under these listings? We evaluate epilepsy, amyotrophic lateral sclerosis, coma or persistent vegetative state (PVS), and neurological disorders that cause disorganization of motor function, bulbar and neuromuscular dysfunction, communication impairment, or a combination of limitations in physical and mental functioning. We evaluate neurological disorders that may manifest in a combination of limitations in physical and mental functioning. For example, if you have a neurological disorder that causes mental limitations, such as Huntington’s disease or early-onset Alzheimer’s disease, which may limit executive functioning (e.g., regulating attention, planning, inhibiting responses, decision-making), we evaluate your limitations using the functional criteria under these listings (see 11.00G). Under this body system, we evaluate the limitations resulting from the impact of the neurological disease process itself. If your neurological disorder results in only mental impairment PO 00000 Frm 00070 Fmt 4700 Sfmt 4700 or if you have a co-occurring mental condition that is not caused by your neurological disorder (for example, dementia), we will evaluate your mental impairment under the mental disorders body system, 12.00. B. What evidence do we need to document your neurological disorder? 1. We need both medical and non-medical evidence (signs, symptoms, and laboratory findings) to assess the effects of your neurological disorder. Medical evidence should include your medical history, examination findings, relevant laboratory tests, and the results of imaging. Imaging refers to medical imaging techniques, such as x-ray, computerized tomography (CT), magnetic resonance imaging (MRI), and electroencephalography (EEG). The imaging must be consistent with the prevailing state of medical knowledge and clinical practice as the proper technique to support the evaluation of the disorder. In addition, the medical evidence may include descriptions of any prescribed treatment and your response to it. We consider non-medical evidence such as statements you or others make about your impairments, your restrictions, your daily activities, or your efforts to work. 2. We will make every reasonable effort to obtain the results of your laboratory and imaging evidence. When the results of any of these tests are part of the existing evidence in your case record, we will evaluate the test results and all other relevant evidence. We will not purchase imaging, or other diagnostic tests, or laboratory tests that are complex, may involve significant risk, or that are invasive. We will not routinely purchase tests that are expensive or not readily available. C. How do we consider adherence to prescribed treatment in neurological disorders? In 11.02 (Epilepsy), 11.06 (Parkinsonian syndrome), and 11.12 (Myasthenia gravis), we require that limitations from these neurological disorders exist despite adherence to prescribed treatment. ‘‘Despite adherence to prescribed treatment’’ means that you have taken medication(s) or followed other treatment procedures for your neurological disorder(s) as prescribed by a physician for three consecutive months but your impairment continues to meet the other listing requirements despite this treatment. You may receive your treatment at a health care facility that you visit regularly, even if you do not see the same physician on each visit. D. What do we mean by disorganization of motor function? 1. Disorganization of motor function means interference, due to your neurological disorder, with movement of two extremities; i.e., the lower extremities, or upper extremities (including fingers, wrists, hands, arms, and shoulders). By two extremities we mean both lower extremities, or both upper extremities, or one upper extremity and one lower extremity. All listings in this body system, except for 11.02 (Epilepsy), 11.10 (Amyotrophic lateral sclerosis), and 11.20 (Coma and persistent vegetative state), include criteria for disorganization of motor function that results in an extreme limitation in your ability to: E:\FR\FM\01JYR1.SGM 01JYR1 asabaliauskas on DSK3SPTVN1PROD with RULES Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations a. Stand up from a seated position; or b. Balance while standing or walking; or c. Use the upper extremities (including fingers, wrists, hands, arms, and shoulders). 2. Extreme limitation means the inability to stand up from a seated position, maintain balance in a standing position and while walking, or use your upper extremities to independently initiate, sustain, and complete work-related activities. The assessment of motor function depends on the degree of interference with standing up; balancing while standing or walking; or using the upper extremities (including fingers, hands, arms, and shoulders). a. Inability to stand up from a seated position means that once seated you are unable to stand and maintain an upright position without the assistance of another person or the use of an assistive device, such as a walker, two crutches, or two canes. b. Inability to maintain balance in a standing position means that you are unable to maintain an upright position while standing or walking without the assistance of another person or an assistive device, such as a walker, two crutches, or two canes. c. Inability to use your upper extremities means that you have a loss of function of both upper extremities (including fingers, wrists, hands, arms, and shoulders) that very seriously limits your ability to independently initiate, sustain, and complete work-related activities involving fine and gross motor movements. Inability to perform fine and gross motor movements could include not being able to pinch, manipulate, and use your fingers; or not being able to use your hands, arms, and shoulders to perform gross motor movements, such as handling, gripping, grasping, holding, turning, and reaching; or not being able to engage in exertional movements such a lifting, carrying, pushing, and pulling. E. How do we evaluate communication impairments under these listings? We must have a description of a recent comprehensive evaluation including all areas of communication, performed by an acceptable medical source, to document a communication impairment associated with a neurological disorder. A communication impairment may occur when a medically determinable neurological impairment results in dysfunction in the parts of the brain responsible for speech and language. We evaluate communication impairments associated with neurological disorders under 11.04A, 11.07C, or 11.11B. We evaluate communication impairments due to nonneurological disorders under 2.09. 1. Under 11.04A, we need evidence documenting that your central nervous system vascular accident or insult (CVA) and sensory or motor aphasia have resulted in ineffective speech or communication. Ineffective speech or communication means there is an extreme limitation in your ability to understand or convey your message in simple spoken language resulting in your inability to demonstrate basic communication skills, such as following onestep commands or telling someone about your basic personal needs without assistance. 2. Under 11.07C, we need evidence documenting that your cerebral palsy has VerDate Sep<11>2014 16:44 Jun 30, 2016 Jkt 238001 resulted in significant interference in your ability to speak, hear, or see. We will find you have ‘‘significant interference’’ in your ability to speak, hear, or see if your signs, such as aphasia, strabismus, or sensorineural hearing loss, seriously limit your ability to communicate on a sustained basis. 3. Under 11.11B, we need evidence documenting that your post-polio syndrome has resulted in the inability to produce intelligible speech. F. What do we mean by bulbar and neuromuscular dysfunction? The bulbar region of the brain is responsible for controlling the bulbar muscles in the throat, tongue, jaw, and face. Bulbar and neuromuscular dysfunction refers to weakness in these muscles, resulting in breathing, swallowing, and speaking impairments. Listings 11.11 (Post-polio syndrome), 11.12 (Myasthenia gravis), and 11.22 (Motor neuron disorders other than ALS) include criteria for evaluating bulbar and neuromuscular dysfunction. If your neurological disorder has resulted in a breathing disorder, we may evaluate that condition under the respiratory system, 3.00. G. How do we evaluate limitations in physical and mental functioning under these listings? 1. Neurological disorders may manifest in a combination of limitations in physical and mental functioning. We consider all relevant information in your case record to determine the effects of your neurological disorder on your physical and mental functioning. To satisfy the requirement described under 11.00G, your neurological disorder must result in a marked limitation in physical functioning and a marked limitation in at least one of four areas of mental functioning: Understanding, remembering, or applying information; interacting with others; concentrating, persisting, or maintaining pace; or adapting or managing oneself. If your neurological disorder results in an extreme limitation in at least one of the four areas of mental functioning, or results in marked limitation in at least two of the four areas of mental functioning, but you do not have at least a marked limitation in your physical functioning, we will consider whether your condition meets or medically equals one of the mental disorders body system listings, 12.00. 2. Marked Limitation. To satisfy the requirements of the functional criteria, your neurological disorder must result in a marked limitation in physical functioning and a marked limitation in one of the four areas of mental functioning (see 11.00G3). Although we do not require the use of such a scale, ‘‘marked’’ would be the fourth point on a five-point scale consisting of no limitation, mild limitation, moderate limitation, marked limitation, and extreme limitation. We consider the nature and overall degree of interference with your functioning. The term ‘‘marked’’ does not require that you must be confined to bed, hospitalized, or in a nursing home. a. Marked limitation and physical functioning. For this criterion, a marked limitation means that, due to the signs and symptoms of your neurological disorder, you are seriously limited in the ability to PO 00000 Frm 00071 Fmt 4700 Sfmt 4700 43053 independently initiate, sustain, and complete work-related physical activities (see 11.00G3). You may have a marked limitation in your physical functioning when your neurological disease process causes persistent or intermittent symptoms that affect your abilities to independently initiate, sustain, and complete work-related activities, such as standing, balancing, walking, using both upper extremities for fine and gross movements, or results in limitations in using one upper and one lower extremity. The persistent and intermittent symptoms must result in a serious limitation in your ability to do a task or activity on a sustained basis. We do not define ‘‘marked’’ by a specific number of different physical activities or tasks that demonstrate your ability, but by the overall effects of your neurological symptoms on your ability to perform such physical activities on a consistent and sustained basis. You need not be totally precluded from performing a function or activity to have a marked limitation, as long as the degree of limitation seriously limits your ability to independently initiate, sustain, and complete work-related physical activities. b. Marked limitation and mental functioning. For this criterion, a marked limitation means that, due to the signs and symptoms of your neurological disorder, you are seriously limited in the ability to function independently, appropriately, effectively, and on a sustained basis in work settings (see 11.03G3). We do not define ‘‘marked’’ by a specific number of mental activities, such as: The number of activities that demonstrate your ability to understand, remember, and apply information; the number of tasks that demonstrate your ability to interact with others; a specific number of tasks that demonstrate you are able to concentrate, persist or maintain pace; or a specific number of tasks that demonstrate you are able to manage yourself. You may have a marked limitation in your mental functioning when several activities or functions are impaired, or even when only one is impaired. You need not be totally precluded from performing an activity to have a marked limitation, as long as the degree of limitation seriously limits your ability to function independently, appropriately, and effectively on a sustained basis, and complete work-related mental activities. 3. Areas of physical and mental functioning. a. Physical functioning. Examples of this criterion include specific motor abilities, such as independently initiating, sustaining, and completing the following activities: Standing up from a seated position, balancing while standing or walking, or using both your upper extremities for fine and gross movements (see 11.00D). Physical functioning may also include functions of the body that support motor abilities, such as the abilities to see, breathe, and swallow (see 11.00E and 11.00F). Examples of when your limitation in seeing, breathing, or swallowing may, on its own, rise to a ‘‘marked’’ limitation include: Prolonged and uncorrectable double vision causing difficulty with balance; prolonged difficulty breathing requiring the use of a prescribed E:\FR\FM\01JYR1.SGM 01JYR1 asabaliauskas on DSK3SPTVN1PROD with RULES 43054 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations assistive breathing device, such as a portable continuous positive airway pressure machine; or repeated instances, occurring at least weekly, of aspiration without causing aspiration pneumonia. Alternatively, you may have a combination of limitations due to your neurological disorder that together rise to a ‘‘marked’’ limitation in physical functioning. We may also find that you have a ‘‘marked’’ limitation in this area if, for example, your symptoms, such as pain or fatigue (see 11.00T), as documented in your medical record, and caused by your neurological disorder or its treatment, seriously limit your ability to independently initiate, sustain, and complete these workrelated motor functions, or the other physical functions or physiological processes that support those motor functions. We may also find you seriously limited in an area if, while you retain some ability to perform the function, you are unable to do so consistently and on a sustained basis. The limitation in your physical functioning must last or be expected to last at least 12 months. These examples illustrate the nature of physical functioning. We do not require documentation of all of the examples. b. Mental functioning. (i) Understanding, remembering, or applying information. This area of mental functioning refers to the abilities to learn, recall, and use information to perform work activities. Examples include: Understanding and learning terms, instructions, procedures; following one- or two-step oral instructions to carry out a task; describing work activity to someone else; asking and answering questions and providing explanations; recognizing a mistake and correcting it; identifying and solving problems; sequencing multi-step activities; and using reason and judgment to make work-related decisions. These examples illustrate the nature of this area of mental functioning. We do not require documentation of all of the examples. (ii) Interacting with others. This area of mental functioning refers to the abilities to relate to and work with supervisors, coworkers, and the public. Examples include: Cooperating with others; asking for help when needed; handling conflicts with others; stating your own point of view; initiating or sustaining conversation; understanding and responding to social cues (physical, verbal, emotional); responding to requests, suggestions, criticism, correction, and challenges; and keeping social interactions free of excessive irritability, sensitivity, argumentativeness, or suspiciousness. These examples illustrate the nature of this area of mental functioning. We do not require documentation of all of the examples. (iii) Concentrating, persisting, or maintaining pace. This area of mental functioning refers to the abilities to focus attention on work activities and to stay ontask at a sustained rate. Examples include: Initiating and performing a task that you understand and know how to do; working at an appropriate and consistent pace; completing tasks in a timely manner; ignoring or avoiding distractions while working; changing activities or work settings without being disruptive; working close to or with others without interrupting or VerDate Sep<11>2014 16:44 Jun 30, 2016 Jkt 238001 distracting them; sustaining an ordinary routine and regular attendance at work; and working a full day without needing more than the allotted number or length of rest periods during the day. These examples illustrate the nature of this area of mental functioning. We do not require documentation of all of the examples. (iv) Adapting or managing oneself. This area of mental functioning refers to the abilities to regulate emotions, control behavior, and maintain well-being in a work setting. Examples include: Responding to demands; adapting to changes; managing your psychologically based symptoms; distinguishing between acceptable and unacceptable work performance; setting realistic goals; making plans for yourself independently of others; maintaining personal hygiene and attire appropriate to a work setting; and being aware of normal hazards and taking appropriate precautions. These examples illustrate the nature of this area of mental functioning. We do not require documentation of all of the examples. 4. Signs and symptoms of your disorder and the effects of treatment. a. We will consider your signs and symptoms and how they affect your ability to function in the work place. When we evaluate your functioning, we will consider whether your signs and symptoms are persistent or intermittent, how frequently they occur and how long they last, their intensity, and whether you have periods of exacerbation and remission. b. We will consider the effectiveness of treatment in improving the signs, symptoms, and laboratory findings related to your neurological disorder, as well as any aspects of treatment that may interfere with your ability to function. We will consider, for example: The effects of medications you take (including side effects); the time-limited efficacy of some medications; the intrusiveness, complexity, and duration of your treatment (for example, the dosing schedule or need for injections); the effects of treatment, including medications, therapy, and surgery, on your functioning; the variability of your response to treatment; and any drug interactions. H. What is epilepsy, and how do we evaluate it under 11.02? 1. Epilepsy is a pattern of recurrent and unprovoked seizures that are manifestations of abnormal electrical activity in the brain. There are various types of generalized and ‘‘focal’’ or partial seizures. However, psychogenic nonepileptic seizures and pseudoseizures are not epileptic seizures for the purpose of 11.02. We evaluate psychogenic seizures and pseudoseizures under the mental disorders body system, 12.00. In adults, the most common potentially disabling seizure types are generalized tonic-clonic seizures and dyscognitive seizures (formerly complex partial seizures). a. Generalized tonic-clonic seizures are characterized by loss of consciousness accompanied by a tonic phase (sudden muscle tensing causing the person to lose postural control) followed by a clonic phase (rapid cycles of muscle contraction and relaxation, also called convulsions). Tongue PO 00000 Frm 00072 Fmt 4700 Sfmt 4700 biting and incontinence may occur during generalized tonic-clonic seizures, and injuries may result from falling. b. Dyscognitive seizures are characterized by alteration of consciousness without convulsions or loss of muscle control. During the seizure, blank staring, change of facial expression, and automatisms (such as lip smacking, chewing or swallowing, or repetitive simple actions, such as gestures or verbal utterances) may occur. During its course, a dyscognitive seizure may progress into a generalized tonic-clonic seizure (see 11.00H1a). 2. Description of seizure. We require at least one detailed description of your seizures from someone, preferably a medical professional, who has observed at least one of your typical seizures. If you experience more than one type of seizure, we require a description of each type. 3. Serum drug levels. We do not require serum drug levels; therefore, we will not purchase them. However, if serum drug levels are available in your medical records, we will evaluate them in the context of the other evidence in your case record. 4. Counting seizures. The period specified in 11.02A, B, or C cannot begin earlier than one month after you began prescribed treatment. The required number of seizures must occur within the period we are considering in connection with your application or continuing disability review. When we evaluate the frequency of your seizures, we also consider your adherence to prescribed treatment (see 11.00C). When we determine the number of seizures you have had in the specified period, we will: a. Count multiple seizures occurring in a 24-hour period as one seizure. b. Count status epilepticus (a continuous series of seizures without return to consciousness between seizures) as one seizure. c. Count a dyscognitive seizure that progresses into a generalized tonic-clonic seizure as one generalized tonic-clonic seizure. d. We do not count seizures that occur during a period when you are not adhering to prescribed treatment without good reason. When we determine that you had good reason for not adhering to prescribed treatment, we will consider your physical, mental, educational, and communicative limitations (including any language barriers). We will consider you to have good reason for not following prescribed treatment if, for example, the treatment is very risky for you due to its consequences or unusual nature, or if you are unable to afford prescribed treatment that you are willing to accept, but for which no free community resources are available. We will follow guidelines found in our policy, such as §§ 404.1530(c) and 416.930(c) of this chapter, when we determine whether you have a good reason for not adhering to prescribed treatment. e. We do not count psychogenic nonepileptic seizures or pseudoseizures under 11.02. We evaluate these seizures under the mental disorders body system, 12.00. 5. Electroencephalography (EEG) testing. We do not require EEG test results; therefore, E:\FR\FM\01JYR1.SGM 01JYR1 asabaliauskas on DSK3SPTVN1PROD with RULES Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations we will not purchase them. However, if EEG test results are available in your medical records, we will evaluate them in the context of the other evidence in your case record. I. What is vascular insult to the brain, and how do we evaluate it under 11.04? 1. Vascular insult to the brain (cerebrum, cerebellum, or brainstem), commonly referred to as stroke or cerebrovascular accident (CVA), is brain cell death caused by an interruption of blood flow within or leading to the brain, or by a hemorrhage from a ruptured blood vessel or aneurysm in the brain. If you have a vision impairment resulting from your vascular insult, we may evaluate that impairment under the special senses body system, 2.00. 2. We need evidence of sensory or motor aphasia that results in ineffective speech or communication under 11.04A (see 11.00E). We may evaluate your communication impairment under listing 11.04C if you have marked limitation in physical functioning and marked limitation in one of the four areas of mental functioning. 3. We generally need evidence from at least 3 months after the vascular insult to evaluate whether you have disorganization of motor functioning under 11.04B, or the impact that your disorder has on your physical and mental functioning under 11.04C. In some cases, evidence of your vascular insult is sufficient to allow your claim within 3 months post-vascular insult. If we are unable to allow your claim within 3 months after your vascular insult, we will defer adjudication of the claim until we obtain evidence of your neurological disorder at least 3 months post-vascular insult. J. What are benign brain tumors, and how do we evaluate them under 11.05? Benign brain tumors are noncancerous (nonmalignant) abnormal growths of tissue in or on the brain that invade healthy brain tissue or apply pressure on the brain or cranial nerves. We evaluate their effects on your functioning as discussed in 11.00D and 11.00G. We evaluate malignant brain tumors under the cancer body system in 13.00. If you have a vision impairment resulting from your benign brain tumor, we may evaluate that impairment under the special senses body system, 2.00. K. What is Parkinsonian syndrome, and how do we evaluate it under 11.06? Parkinsonian syndrome is a term that describes a group of chronic, progressive movement disorders resulting from loss or decline in the function of dopamineproducing brain cells. Dopamine is a neurotransmitter that regulates muscle movement throughout the body. When we evaluate your Parkinsonian syndrome, we will consider your adherence to prescribed treatment (see 11.00C). L. What is cerebral palsy, and how do we evaluate it under 11.07? 1. Cerebral palsy (CP) is a term that describes a group of static, nonprogressive disorders caused by abnormalities within the brain that disrupt the brain’s ability to control movement, muscle coordination, and posture. The resulting motor deficits manifest very early in a person’s development, with delayed or abnormal progress in attaining developmental milestones. Deficits may VerDate Sep<11>2014 16:44 Jun 30, 2016 Jkt 238001 become more obvious as the person grows and matures over time. 2. We evaluate your signs and symptoms, such as ataxia, spasticity, flaccidity, athetosis, chorea, and difficulty with precise movements when we determine your ability to stand up, balance, walk, or perform fine and gross motor movements. We will also evaluate your signs, such as dysarthria and apraxia of speech, and receptive and expressive language problems when we determine your ability to communicate. 3. We will consider your other impairments or signs and symptoms that develop secondary to the disorder, such as post-impairment syndrome (a combination of pain, fatigue, and weakness due to muscle abnormalities); overuse syndromes (repetitive motion injuries); arthritis; abnormalities of proprioception (perception of the movements and position of the body); abnormalities of stereognosis (perception and identification of objects by touch); learning problems; anxiety; and depression. M. What are spinal cord disorders, and how do we evaluate them under 11.08? 1. Spinal cord disorders may be congenital or caused by injury to the spinal cord. Motor signs and symptoms of spinal cord disorders include paralysis, flaccidity, spasticity, and weakness. 2. Spinal cord disorders with complete loss of function (11.08A) addresses spinal cord disorders that result in a complete lack of motor, sensory, and autonomic function of the affected part(s) of the body. 3. Spinal cord disorders with disorganization of motor function (11.08B) addresses spinal cord disorders that result in less than a complete loss of function of the affected part(s) of the body, reducing, but not eliminating, motor, sensory, and autonomic function. 4. When we evaluate your spinal cord disorder, we generally need evidence from at least 3 months after your symptoms began in order to evaluate your disorganization of motor function. In some cases, evidence of your spinal cord disorder may be sufficient to allow your claim within 3 months after the spinal cord disorder. If the medical evidence demonstrates total cord transection causing a loss of motor and sensory functions below the level of injury, we will not wait 3 months but will make the allowance decision immediately. N. What is multiple sclerosis, and how do we evaluate it under 11.09? 1. Multiple sclerosis (MS) is a chronic, inflammatory, degenerative disorder that damages the myelin sheath surrounding the nerve fibers in the brain and spinal cord. The damage disrupts the normal transmission of nerve impulses within the brain and between the brain and other parts of the body, causing impairment in muscle coordination, strength, balance, sensation, and vision. There are several forms of MS, ranging from mildly to highly aggressive. Milder forms generally involve acute attacks (exacerbations) with partial or complete recovery from signs and symptoms (remissions). Aggressive forms generally exhibit a steady progression of signs and symptoms with few or no remissions. The effects of all forms vary from person to person. PO 00000 Frm 00073 Fmt 4700 Sfmt 4700 43055 2. We evaluate your signs and symptoms, such as flaccidity, spasticity, spasms, incoordination, imbalance, tremor, physical fatigue, muscle weakness, dizziness, tingling, and numbness when we determine your ability to stand up, balance, walk, or perform fine and gross motor movements. When determining whether you have limitations of physical and mental functioning, we will consider your other impairments or signs and symptoms that develop secondary to the disorder, such as fatigue; visual loss; trouble sleeping; impaired attention, concentration, memory, or judgment; mood swings; and depression. If you have a vision impairment resulting from your MS, we may evaluate that impairment under the special senses body system, 2.00. O. What is amyotrophic lateral sclerosis, and how do we evaluate it under 11.10? Amyotrophic lateral sclerosis (ALS) is a type of motor neuron disorder that rapidly and progressively attacks the nerve cells responsible for controlling voluntary muscles. We establish ALS under 11.10 when you have a documented diagnosis of ALS. We require documentation based on generally accepted methods consistent with the prevailing state of medical knowledge and clinical practice. We require laboratory testing to establish the diagnosis when the clinical findings of upper and lower motor neuron disease are not present in three or more regions. Electrophysiological studies, such as nerve conduction velocity studies and electromyography (EMG), may support your diagnosis of ALS; however, we will not purchase these studies. P. What are neurodegenerative disorders of the central nervous system, such as Huntington’s disease, Friedreich’s ataxia, and spinocerebellar degeneration, and how do we evaluate them under 11.17? Neurodegenerative disorders of the central nervous system are disorders characterized by progressive and irreversible degeneration of neurons or their supporting cells. Over time, these disorders impair many of the body’s motor, cognitive, and other mental functions. We consider neurodegenerative disorders of the central nervous system under 11.17 that we do not evaluate elsewhere in section 11.00, such as Huntington’s disease (HD), Friedreich’s ataxia, spinocerebellar degeneration, Creutzfeldt-Jakob disease (CJD), progressive supranuclear palsy (PSP), earlyonset Alzheimer’s disease, and frontotemporal dementia (Pick’s disease). When these disorders result in solely cognitive and other mental function effects, we will evaluate the disorder under the mental disorder listings. Q. What is traumatic brain injury, and how do we evaluate it under 11.18? 1. Traumatic brain injury (TBI) is damage to the brain resulting from skull fracture, collision with an external force leading to a closed head injury, or penetration by an object that enters the skull and makes contact with brain tissue. We evaluate TBI that results in coma or persistent vegetative state (PVS) under 11.20. 2. We generally need evidence from at least 3 months after the TBI to evaluate whether you have disorganization of motor function under 11.18A or the impact that your E:\FR\FM\01JYR1.SGM 01JYR1 asabaliauskas on DSK3SPTVN1PROD with RULES 43056 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations disorder has on your physical and mental functioning under 11.18B. In some cases, evidence of your TBI is sufficient to determine disability within 3 months postTBI. If we are unable to allow your claim within 3 months post-TBI, we will defer adjudication of the claim until we obtain evidence of your neurological disorder at least 3 months post-TBI. If a finding of disability still is not possible at that time, we will again defer adjudication of the claim until we obtain evidence at least 6 months after your TBI. R. What are coma and persistent vegetative state, and how do we evaluate them under 11.20? Coma is a state of unconsciousness in which a person does not exhibit a sleep/wake cycle, and is unable to perceive or respond to external stimuli. People who do not fully emerge from coma may progress into a persistent vegetative state (PVS). PVS is a condition of partial arousal in which a person may have a low level of consciousness but is still unable to react to external stimuli. In contrast to coma, a person in a PVS retains sleep/wake cycles and may exhibit some key lower brain functions, such as spontaneous movement, opening and moving eyes, and grimacing. Coma or PVS may result from TBI, a nontraumatic insult to the brain (such as a vascular insult, infection, or brain tumor), or a neurodegenerative or metabolic disorder. Medically induced comas are not considered under 11.20 and should be considered under the section pertaining to the underlying reason the coma was medically induced and not under this section. S. What are motor neuron disorders, other than ALS, and how do we evaluate them under 11.22? Motor neuron disorders such as progressive bulbar palsy, primary lateral sclerosis (PLS), and spinal muscular atrophy (SMA) are progressive neurological disorders that destroy the cells that control voluntary muscle activity, such as walking, breathing, swallowing, and speaking. We evaluate the effects of these disorders on motor functioning, bulbar and neuromuscular functioning, oral communication, or limitations in physical and mental functioning. T. How do we consider symptoms of fatigue in these listings? Fatigue is one of the most common and limiting symptoms of some neurological disorders, such as multiple sclerosis, post-polio syndrome, and myasthenia gravis. These disorders may result in physical fatigue (lack of muscle strength) or mental fatigue (decreased awareness or attention). When we evaluate your fatigue, we will consider the intensity, persistence, and effects of fatigue on your functioning. This may include information such as the clinical and laboratory data and other objective evidence concerning your neurological deficit, a description of fatigue considered characteristic of your disorder, and information about your functioning. We consider the effects of physical fatigue on your ability to stand up, balance, walk, or perform fine and gross motor movements using the criteria described in 11.00D. We consider the effects of physical and mental fatigue when we evaluate your physical and mental functioning described in 11.00G. VerDate Sep<11>2014 16:44 Jun 30, 2016 Jkt 238001 U. How do we evaluate your neurological disorder when it does not meet one of these listings? 1. If your neurological disorder does not meet the criteria of any of these listings, we must also consider whether your impairment(s) meets the criteria of a listing in another body system. If you have a severe medically determinable impairment(s) that does not meet a listing, we will determine whether your impairment(s) medically equals a listing. See §§ 404.1526 and 416.926 of this chapter. 2. If your impairment(s) does not meet or medically equal the criteria of a listing, you may or may not have the residual functional capacity to perform your past relevant work or adjust to other work that exists in significant numbers in the national economy, which we determine at the fourth and, if necessary, the fifth steps of the sequential evaluation process in §§ 404.1520 and 416.920 of this chapter. 3. We use the rules in §§ 404.1594 and 416.994 of this chapter, as appropriate, when we decide whether you continue to be disabled. 11.01 Category of Impairments, Neurological Disorders 11.02 Epilepsy, documented by a detailed description of a typical seizure and characterized by A, B, C, or D: A. Generalized tonic-clonic seizures (see 11.00H1a), occurring at least once a month for at least 3 consecutive months (see 11.00H4) despite adherence to prescribed treatment (see 11.00C); or B. Dyscognitive seizures (see 11.00H1b), occurring at least once a week for at least 3 consecutive months (see 11.00H4) despite adherence to prescribed treatment (see 11.00C); or C. Generalized tonic-clonic seizures (see 11.00H1a), occurring at least once every 2 months for at least 4 consecutive months (see 11.00H4) despite adherence to prescribed treatment (see 11.00C); and a marked limitation in one of the following: 1. Physical functioning (see 11.00G3a); or 2. Understanding, remembering, or applying information (see 11.00G3b(i)); or 3. Interacting with others (see 11.00G3b(ii)); or 4. Concentrating, persisting, or maintaining pace (see 11.00G3b(iii)); or 5. Adapting or managing oneself (see 11.00G3b(iv)); or D. Dyscognitive seizures (see 11.00H1b), occurring at least once every 2 weeks for at least 3 consecutive months (see 11.00H4) despite adherence to prescribed treatment (see 11.00C); and a marked limitation in one of the following: 1. Physical functioning (see 11.00G3a); or 2. Understanding, remembering, or applying information (see 11.00G3b(i)); or 3. Interacting with others (see 11.00G3b(ii)); or 4. Concentrating, persisting, or maintaining pace (see 11.00G3b(iii)); or 5. Adapting or managing oneself (see 11.00G3b(iv)). 11.03 [Reserved] 11.04 Vascular insult to the brain, characterized by A, B, or C: PO 00000 Frm 00074 Fmt 4700 Sfmt 4700 A. Sensory or motor aphasia resulting in ineffective speech or communication (see 11.00E1) persisting for at least 3 consecutive months after the insult; or B. Disorganization of motor function in two extremities (see 11.00D1), resulting in an extreme limitation (see 11.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities, persisting for at least 3 consecutive months after the insult; or C. Marked limitation (see 11.00G2) in physical functioning (see 11.00G3a) and in one of the following areas of mental functioning, both persisting for at least 3 consecutive months after the insult: 1. Understanding, remembering, or applying information (see 11.00G3b(i)); or 2. Interacting with others (see 11.00G3b(ii)); or 3. Concentrating, persisting, or maintaining pace (see 11.00G3b(iii)); or 4. Adapting or managing oneself (see 11.00G3b(iv)). 11.05 Benign brain tumors, characterized by A or B: A. Disorganization of motor function in two extremities (see 11.00D1), resulting in an extreme limitation (see 11.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities; or B. Marked limitation (see 11.00G2) in physical functioning (see 11.00G3a), and in one of the following: 1. Understanding, remembering, or applying information (see 11.00G3b(i)); or 2. Interacting with others (see 11.00G3b(ii)); or 3. Concentrating, persisting, or maintaining pace (see 11.00G3b(iii)); or 4. Adapting or managing oneself (see 11.00G3b(iv)). 11.06 Parkinsonian syndrome, characterized by A or B despite adherence to prescribed treatment for at least 3 consecutive months (see 11.00C): A. Disorganization of motor function in two extremities (see 11.00D1), resulting in an extreme limitation (see 11.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities; or B. Marked limitation (see 11.00G2) in physical functioning (see 11.00G3a), and in one of the following: 1. Understanding, remembering, or applying information (see 11.00G3b(i)); or 2. Interacting with others (see 11.00G3b(ii)); or 3. Concentrating, persisting, or maintaining pace (see 11.00G3b(iii)); or 4. Adapting or managing oneself (see 11.00G3b(iv)). 11.07 Cerebral palsy, characterized by A, B, or C: A. Disorganization of motor function in two extremities (see 11.00D1), resulting in an extreme limitation (see 11.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities; or B. Marked limitation (see 11.00G2) in physical functioning (see 11.00G3a), and in one of the following: 1. Understanding, remembering, or applying information (see 11.00G3b(i)); or E:\FR\FM\01JYR1.SGM 01JYR1 asabaliauskas on DSK3SPTVN1PROD with RULES Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations 2. Interacting with others (see 11.00G3b(ii)); or 3. Concentrating, persisting, or maintaining pace (see 11.00G3b(iii)); or 4. Adapting or managing oneself (see 11.00G3b(iv)); or C. Significant interference in communication due to speech, hearing, or visual deficit (see 11.00E2). 11.08 Spinal cord disorders, characterized by A, B, or C: A. Complete loss of function, as described in 11.00M2, persisting for 3 consecutive months after the disorder (see 11.00M4); or B. Disorganization of motor function in two extremities (see 11.00D1), resulting in an extreme limitation (see 11.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities persisting for 3 consecutive months after the disorder (see 11.00M4); or C. Marked limitation (see 11.00G2) in physical functioning (see 11.00G3a) and in one of the following areas of mental functioning, both persisting for 3 consecutive months after the disorder (see 11.00M4): 1. Understanding, remembering, or applying information (see 11.00G3b(i)); or 2. Interacting with others (see 11.00G3b(ii)); or 3. Concentrating, persisting, or maintaining pace (see 11.00G3b(iii)); or 4. Adapting or managing oneself (see 11.00G3b(iv)). 11.09 Multiple sclerosis, characterized by A or B: A. Disorganization of motor function in two extremities (see 11.00D1), resulting in an extreme limitation (see 11.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities; or B. Marked limitation (see 11.00G2) in physical functioning (see 11.00G3a), and in one of the following: 1. Understanding, remembering, or applying information (see 11.00G3b(i)); or 2. Interacting with others (see 11.00G3b(ii)); or 3. Concentrating, persisting, or maintaining pace (see 11.00G3b(iii)); or 4. Adapting or managing oneself (see 11.00G3b(iv)). 11.10 Amyotrophic lateral sclerosis (ALS) established by clinical and laboratory findings (see 11.00O). 11.11 Post-polio syndrome, characterized by A, B, C, or D: A. Disorganization of motor function in two extremities (see 11.00D1), resulting in an extreme limitation (see 11.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities; or B. Unintelligible speech (see 11.00E3); or C. Bulbar and neuromuscular dysfunction (see 11.00F), resulting in: 1. Acute respiratory failure requiring mechanical ventilation; or 2. Need for supplemental enteral nutrition via a gastrostomy or parenteral nutrition via a central venous catheter; or D. Marked limitation (see 11.00G2) in physical functioning (see 11.00G3a), and in one of the following: 1. Understanding, remembering, or applying information (see 11.00G3b(i)); or VerDate Sep<11>2014 16:44 Jun 30, 2016 Jkt 238001 2. Interacting with others (see 11.00G3b(ii)); or 3. Concentrating, persisting, or maintaining pace (see 11.00G3b(iii)); or 4. Adapting or managing oneself (see 11.00G3b(iv)). 11.12 Myasthenia gravis, characterized by A, B, or C despite adherence to prescribed treatment for at least 3 months (see 11.00C): A. Disorganization of motor function in two extremities (see 11.00D1), resulting in an extreme limitation (see 11.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities; or B. Bulbar and neuromuscular dysfunction (see 11.00F), resulting in: 1. One myasthenic crisis requiring mechanical ventilation; or 2. Need for supplemental enteral nutrition via a gastrostomy or parenteral nutrition via a central venous catheter; or C. Marked limitation (see 11.00G2) in physical functioning (see 11.00G3a), and in one of the following: 1. Understanding, remembering, or applying information (see 11.00G3b(i)); or 2. Interacting with others (see 11.00G3b(ii)); or 3. Concentrating, persisting, or maintaining pace (see 11.00G3b(iii)); or 4. Adapting or managing oneself (see 11.00G3b(iv)). 11.13 Muscular dystrophy, characterized by A or B: A. Disorganization of motor function in two extremities (see 11.00D1), resulting in an extreme limitation (see 11.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities; or B. Marked limitation (see 11.00G2) in physical functioning (see 11.00G3a), and in one of the following: 1. Understanding, remembering, or applying information (see 11.00G3b(i)); or 2. Interacting with others (see 11.00G3b(ii)); or 3. Concentrating, persisting, or maintaining pace (see 11.00G3b(iii)); or 4. Adapting or managing oneself (see 11.00G3b(iv)). 11.14 Peripheral neuropathy, characterized by A or B: A. Disorganization of motor function in two extremities (see 11.00D1), resulting in an extreme limitation (see 11.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities; or B. Marked limitation (see 11.00G2) in physical functioning (see 11.00G3a), and in one of the following: 1. Understanding, remembering, or applying information (see 11.00G3b(i)); or 2. Interacting with others (see 11.00G3b(ii)); or 3. Concentrating, persisting, or maintaining pace (see 11.00G3b(iii)); or 4. Adapting or managing oneself (see 11.00G3b(iv)). 11.15 [Reserved] 11.16 [Reserved] 11.17 Neurodegenerative disorders of the central nervous system, such as Huntington’s disease, Friedreich’s ataxia, and PO 00000 Frm 00075 Fmt 4700 Sfmt 4700 43057 spinocerebellar degeneration, characterized by A or B: A. Disorganization of motor function in two extremities (see 11.00D1), resulting in an extreme limitation (see 11.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities; or B. Marked limitation (see 11.00G2) in physical functioning (see 11.00G3a), and in one of the following: 1. Understanding, remembering, or applying information (see 11.00G3b(i)); or 2. Interacting with others (see 11.00G3b(ii)); or 3. Concentrating, persisting, or maintaining pace (see 11.00G3b(iii)); or 4. Adapting or managing oneself (see 11.00G3b(iv)). 11.18 Traumatic brain injury, characterized by A or B: A. Disorganization of motor function in two extremities (see 11.00D1), resulting in an extreme limitation (see 11.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities, persisting for at least 3 consecutive months after the injury; or B. Marked limitation (see 11.00G2) in physical functioning (see 11.00G3a), and in one of the following areas of mental functioning, persisting for at least 3 consecutive months after the injury: 1. Understanding, remembering, or applying information (see 11.00G3b(i)); or 2. Interacting with others (see 11.00G3b(ii)); or 3. Concentrating, persisting, or maintaining pace (see 11.00G3b(iii)); or 4. Adapting or managing oneself (see 11.00G3b(iv)). 11.19 [Reserved] 11.20 Coma or persistent vegetative state, persisting for at least 1 month. 11.21 [Reserved] 11.22 Motor neuron disorders other than ALS, characterized by A, B, or C: A. Disorganization of motor function in two extremities (see 11.00D1), resulting in an extreme limitation (see 11.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities; or B. Bulbar and neuromuscular dysfunction (see 11.00F), resulting in: 1. Acute respiratory failure requiring invasive mechanical ventilation; or 2. Need for supplemental enteral nutrition via a gastrostomy or parenteral nutrition via a central venous catheter; or C. Marked limitation (see 11.00G2) in physical functioning (see 11.00G3a), and in one of the following: 1. Understanding, remembering, or applying information (see 11.00G3b(i)); or 2. Interacting with others (see 11.00G3b(ii)); or 3. Concentrating, persisting, or maintaining pace (see 11.00G3b(iii)); or 4. Adapting or managing oneself (see 11.00G3b(iv)). * * 12.00 * * * * D. * * * E:\FR\FM\01JYR1.SGM * * MENTAL DISORDERS 01JYR1 * * 43058 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations 10. Traumatic brain injury (TBI). In cases involving TBI, follow the documentation and evaluation guidelines in 11.00Q. * * * * * 12.01 Category of Impairments, Mental Disorders * * * * * 12.09 * * * E. Peripheral neuropathy. Evaluate under 11.14. * * * * * I. Seizures. Evaluate under 11.02. * * * * * * * * Part B * * 111.00 * * 101.00 * * Neurological Disorders * * * MUSCULOSKELETAL SYSTEM * * * B. Loss of function. 1. General. * * * We evaluate impairments with neurological causes under 111.00, as appropriate. * * * * * K. Disorders of the spine, listed in 101.04, result in limitations because of distortion of the bony and ligamentous architecture of the spine and associated impingement on nerve roots (including the cauda equina) or spinal cord. Such impingement on nerve tissue may result from a herniated nucleus pulposus, spinal stenosis, arachnoiditis, or other miscellaneous conditions. asabaliauskas on DSK3SPTVN1PROD with RULES * * * * * 111.00 NEUROLOGICAL DISORDERS A. Which neurological disorders do we evaluate under these listings? We evaluate epilepsy, coma or persistent vegetative state (PVS), and neurological disorders that cause disorganization of motor function, bulbar and neuromuscular dysfunction, or communication impairment. Under this body system, we evaluate the limitations resulting from the impact of the neurological disease process itself. If you have a neurological disorder(s) that affects your physical and mental functioning, we will evaluate your impairments under the rules we use to determine functional equivalence. If your neurological disorder results in only mental impairment or if you have a co-occurring mental condition that is not caused by your neurological disorder (for example, Autism spectrum disorder), we will evaluate your mental impairment under the mental disorders body system, 112.00. B. What evidence do we need to document your neurological disorder? 1. We need both medical and non-medical evidence (signs, symptoms, and laboratory findings) to assess the effects of your neurological disorder. Medical evidence should include your medical history, examination findings, relevant laboratory tests, and the results of imaging. Imaging refers to medical imaging techniques, such as x-ray, computerized tomography (CT), magnetic resonance imaging (MRI), and electroencephalography (EEG). The imaging must be consistent with the prevailing state of medical knowledge and clinical practice as the proper technique to support the VerDate Sep<11>2014 16:44 Jun 30, 2016 Jkt 238001 evaluation of the disorder. In addition, the medical evidence may include descriptions of any prescribed treatment and your response to it. We consider non-medical evidence such as statements you or others make about your impairments, your restrictions, your daily activities, or, if you are an adolescent, your efforts to work. 2. We will make every reasonable effort to obtain the results of your laboratory and imaging evidence. When the results of any of these tests are part of the existing evidence in your case record, we will evaluate the test results and all other relevant evidence. We will not purchase imaging, or other diagnostic tests or laboratory tests that are complex, may involve significant risk, or that are invasive. We will not routinely purchase tests that are expensive or not readily available. C. How do we consider adherence to prescribed treatment in neurological disorders? In 111.02 (Epilepsy) and 111.12 (Myasthenia gravis), we require that limitations from these neurological disorders exist despite adherence to prescribed treatment. ‘‘Despite adherence to prescribed treatment’’ means that you have taken medication(s) or followed other treatment procedures for your neurological disorder(s) as prescribed by a physician for three consecutive months but your impairment continues to meet the other listing requirements despite this treatment. You may receive your treatment at a health care facility that you visit regularly, even if you do not see the same physician on each visit. D. What do we mean by disorganization of motor function? 1. Disorganization of motor function means interference, due to your neurological disorder, with movement of two extremities; i.e., the lower extremities, or upper extremities (including fingers, wrists, hands, arms, and shoulders). By two extremities we mean both lower extremities, or both upper extremities, or one upper extremity and one lower extremity. All listings in this body system, except for 111.02 (Epilepsy) and 111.20 (Coma and persistent vegetative state), include criteria for disorganization of motor function that results in an extreme limitation in your ability to: a. Stand up from a seated position; or b. Balance while standing or walking; or c. Use the upper extremities (e.g., fingers, wrists, hands, arms, and shoulders). 2. Extreme limitation means the inability to stand up from a seated position, maintain balance in a standing position and while walking, or use your upper extremities to independently initiate, sustain, and complete age-appropriate activities. The assessment of motor function depends on the degree of interference with standing up; balancing while standing or walking; or using the upper extremities (including fingers, hands, arms, and shoulders). a. Inability to stand up from a seated position means that once seated you are unable to stand and maintain an upright position without the assistance of another person or the use of an assistive device, such as a walker, two crutches, or two canes. b. Inability to maintain balance in a standing position means that you are unable PO 00000 Frm 00076 Fmt 4700 Sfmt 4700 to maintain an upright position while standing or walking without the assistance of another person or an assistive device, such as a walker, two crutches, or two canes. c. Inability to use your upper extremities means that you have a loss of function of both upper extremities (e.g., fingers, wrists, hands, arms, and shoulders) that very seriously limits your ability to independently initiate, sustain, and complete ageappropriate activities involving fine and gross motor movements. Inability to perform fine and gross motor movements could include not being able to pinch, manipulate, and use your fingers; or not being able to use your hands, arms, and shoulders to perform gross motor movements, such as handling, gripping, grasping, holding, turning, and reaching; or not being able to engage in exertional movements such a lifting, carrying, pushing, and pulling. 3. For children who are not yet able to balance, stand up, or walk independently, we consider their function based on assessments of limitations in the ability to perform comparable age-appropriate activities with the lower and upper extremities, given normal developmental milestones. For such children, an extreme level of limitation means developmental milestones at less than one-half of the child’s chronological age. E. What do we mean by bulbar and neuromuscular dysfunction? The bulbar region of the brain is responsible for controlling the bulbar muscles in the throat, tongue, jaw, and face. Bulbar and neuromuscular dysfunction refers to weakness in these muscles, resulting in breathing, swallowing, and speaking impairments. Listings 111.12 (Myasthenia gravis) and 111.22 (Motor neuron disorders) include criteria for evaluating bulbar and neuromuscular dysfunction. If your neurological disorder has resulted in a breathing disorder, we may evaluate that condition under the respiratory system, 103.00. F. What is epilepsy, and how do we evaluate it under 111.02? 1. Epilepsy is a pattern of recurrent and unprovoked seizures that are manifestations of abnormal electrical activity in the brain. There are various types of generalized and ‘‘focal’’ or partial seizures. In children, the most common potentially disabling seizure types are generalized tonic-clonic seizures, dyscognitive seizures (formerly complex partial seizures), and absence seizures. However, psychogenic nonepileptic seizures and pseudoseizures are not epileptic seizures for the purpose of 111.02. We evaluate psychogenic seizures and pseudoseizures under the mental disorders body system, 112.00. a. Generalized tonic-clonic seizures are characterized by loss of consciousness accompanied by a tonic phase (sudden muscle tensing causing the child to lose postural control) followed by a clonic phase (rapid cycles of muscle contraction and relaxation, also called convulsions). Tongue biting and incontinence may occur during generalized tonic-clonic seizures, and injuries may result from falling. b. Dyscognitive seizures are characterized by alteration of consciousness without E:\FR\FM\01JYR1.SGM 01JYR1 asabaliauskas on DSK3SPTVN1PROD with RULES Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations convulsions or loss of muscle control. During the seizure, blank staring, change of facial expression, and automatisms (such as lip smacking, chewing or swallowing, or repetitive simple actions, such as gestures or verbal utterances) may occur. During its course, a dyscognitive seizure may progress into a generalized tonic-clonic seizure (see 111.00F1a). c. Absence seizures (petit mal) are also characterized by an alteration in consciousness, but are shorter than other generalized seizures (e.g., tonic-clonic and dyscognitive) seizures, generally lasting for only a few seconds rather than minutes. They may present with blank staring, change of facial expression, lack of awareness and responsiveness, and a sense of lost time after the seizure. An aura never precedes absence seizures. Although absence seizures are brief, frequent occurrence may limit functioning. This type of seizure usually does not occur after adolescence. d. Febrile seizures may occur in young children in association with febrile illnesses. We will consider seizures occurring during febrile illnesses. To meet 111.02, we require documentation of seizures during nonfebrile periods and epilepsy must be established. 2. Description of seizure. We require at least one detailed description of your seizures from someone, preferably a medical professional, who has observed at least one of your typical seizures. If you experience more than one type of seizure, we require a description of each type. 3. Serum drug levels. We do not require serum drug levels; therefore, we will not purchase them. However, if serum drug levels are available in your medical records, we will evaluate them in the context of the other evidence in your case record. 4. Counting seizures. The period specified in 111.02A or B cannot begin earlier than one month after you began prescribed treatment. The required number of seizures must occur within the period we are considering in connection with your application or continuing disability review. When we evaluate the frequency of your seizures, we also consider your adherence to prescribed treatment (see 111.00C). When we determine the number of seizures you have had in the specified period, we will: a. Count multiple seizures occurring in a 24-hour period as one seizure. b. Count status epilepticus (a continuous series of seizures without return to consciousness between seizures) as one seizure. c. Count a dyscognitive seizure that progresses into a generalized tonic-clonic seizure as one generalized tonic-clonic seizure. d. We do not count seizures that occur during a period when you are not adhering to prescribed treatment without good reason. When we determine that you had a good reason for not adhering to prescribed treatment, we will consider your physical, mental, educational, and communicative limitations (including any language barriers). We will consider you to have good reason for not following prescribed treatment if, for example, the treatment is very risky for you due to its consequences or unusual nature, or VerDate Sep<11>2014 16:44 Jun 30, 2016 Jkt 238001 if you are unable to afford prescribed treatment that you are willing to accept, but for which no free community resources are available. We will follow guidelines found in our policy, such as § 416.930(c) of this chapter, when we determine whether you have a good reason for not adhering to prescribed treatment. e. We do not count psychogenic nonepileptic seizures or pseudoseizures under 111.02.We evaluate these seizures under the mental disorders body system, 112.00. 5. Electroencephalography (EEG) testing. We do not require EEG test results; therefore, we will not purchase them. However, if EEG test results are available in your medical records, we will evaluate them in the context of the other evidence in your case record. G. What is vascular insult to the brain, and how do we evaluate it under 111.04? 1. Vascular insult to the brain (cerebrum, cerebellum, or brainstem), commonly referred to as stroke or cerebrovascular accident (CVA), is brain cell death caused by an interruption of blood flow within or leading to the brain, or by a hemorrhage from a ruptured blood vessel or aneurysm in the brain. If you have a vision impairment resulting from your vascular insult, we may evaluate that impairment under the special senses body system, 102.00. 2. We generally need evidence from at least 3 months after the vascular insult to determine whether you have disorganization of motor function under 111.04. In some cases, evidence of your vascular insult is sufficient to allow your claim within 3 months post-vascular insult. If we are unable to allow your claim within 3 months after your vascular insult, we will defer adjudication of the claim until we obtain evidence of your neurological disorder at least 3 months post-vascular insult. H. What are benign brain tumors, and how do we evaluate them under 111.05? Benign brain tumors are noncancerous (nonmalignant) abnormal growths of tissue in or on the brain that invade healthy brain tissue or apply pressure on the brain or cranial nerves. We evaluate their effects on your functioning as discussed in 111.00D. We evaluate malignant brain tumors under the cancer body system in 113.00. If you have a vision impairment resulting from your benign brain tumor, we may evaluate that impairment under the special senses body system, 102.00. I. What is cerebral palsy, and how do we evaluate it under 111.07? 1. Cerebral palsy (CP) is a term that describes a group of static, nonprogressive disorders caused by abnormalities within the brain that disrupt the brain’s ability to control movement, muscle coordination, and posture. The resulting motor deficits manifest very early in a child’s development, with delayed or abnormal progress in attaining developmental milestones; deficits may become more obvious as the child grows and matures over time. 2. We evaluate your signs and symptoms, such as ataxia, spasticity, flaccidity, athetosis, chorea, and difficulty with precise movements when we determine your ability to stand up, balance, walk, or perform fine PO 00000 Frm 00077 Fmt 4700 Sfmt 4700 43059 and gross motor movements. We will also evaluate your signs, such as dysarthria and apraxia of speech, and receptive and expressive language problems when we determine your ability to communicate. 3. We will consider your other impairments or signs and symptoms that develop secondary to the disorder, such as post-impairment syndrome (a combination of pain, fatigue, and weakness due to muscle abnormalities); overuse syndromes (repetitive motion injuries); arthritis; abnormalities of proprioception (perception of the movements and position of the body); abnormalities of stereognosis (perception and identification of objects by touch); learning problems; anxiety; and depression. J. What are spinal cord disorders, and how do we evaluate them under 111.08? 1. Spinal cord disorders may be congenital or caused by injury to the spinal cord. Motor signs and symptoms of spinal cord disorders include paralysis, flaccidity, spasticity, and weakness. 2. Spinal cord disorders with complete loss of function (111.08A) addresses spinal cord disorders that result in complete lack of motor, sensory, and autonomic function of the affected part(s) of the body. 3. Spinal cord disorders with disorganization of motor function (111.08B) addresses spinal cord disorders that result in less than complete loss of function of the affected part(s) of the body, reducing, but not eliminating, motor, sensory, and autonomic function. 4. When we evaluate your spinal cord disorder, we generally need evidence from at least 3 months after your symptoms began in order to evaluate your disorganization of motor function. In some cases, evidence of your spinal cord disorder may be sufficient to allow your claim within 3 months after the spinal cord disorder. If the medical evidence demonstrates total cord transection causing a loss of motor and sensory functions below the level of injury, we will not wait 3 months but will make the allowance decision immediately. K. What are communication impairments associated with neurological disorders, and how do we evaluate them under 111.09? 1. Communication impairments result from medically determinable neurological disorders that cause dysfunction in the parts of the brain responsible for speech and language. Under 111.09, we must have recent comprehensive evaluation including all areas of affective and effective communication, performed by a qualified professional, to document a communication impairment associated with a neurological disorder. 2. Under 111.09A, we need documentation from a qualified professional that your neurological disorder has resulted in a speech deficit that significantly affects your ability to communicate. Significantly affects means that you demonstrate a serious limitation in communicating, and a person who is unfamiliar with you cannot easily understand or interpret your speech. 3. Under 111.09B, we need documentation from a qualified professional that shows that your neurological disorder has resulted in a comprehension deficit that results in ineffective verbal communication for your E:\FR\FM\01JYR1.SGM 01JYR1 asabaliauskas on DSK3SPTVN1PROD with RULES 43060 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations age. For the purposes of 111.09B, comprehension deficit means a deficit in receptive language. Ineffective verbal communication means that you demonstrate serious limitation in your ability to communicate orally on the same level as other children of the same age and level of development. 4. Under 111.09C, we need documentation of a neurological disorder that has resulted in hearing loss. Your hearing loss will be evaluated under listing 102.10 or 102.11. 5. We evaluate speech deficits due to nonneurological disorders under 2.09. L. What are neurodegenerative disorders of the central nervous system, such as Juvenileonset Huntington’s disease and Friedreich’s ataxia, and how do we evaluate them under 111.17? Neurodegenerative disorders of the central nervous system are disorders characterized by progressive and irreversible degeneration of neurons or their supporting cells. Over time, these disorders impair many of the body’s motor or cognitive and other mental functions. We consider neurodegenerative disorders of the central nervous system under 111.17 that we do not evaluate elsewhere in section 111.00, such as juvenile-onset Huntington’s disease (HD) and Friedreich’s ataxia. When these disorders result in solely cognitive and other mental functional limitations, we will evaluate the disorder under the mental disorder listings, 112.00. M. What is traumatic brain injury, and how do we evaluate it under 111.18? 1. Traumatic brain injury (TBI) is damage to the brain resulting from skull fracture, collision with an external force leading to a closed head injury, or penetration by an object that enters the skull and makes contact with brain tissue. We evaluate a TBI that results in coma or persistent vegetative state (PVS) under 111.20. 2. We generally need evidence from at least 3 months after the TBI to evaluate whether you have disorganization of motor function under 111.18. In some cases, evidence of your TBI is sufficient to determine disability. If we are unable to allow your claim within 3 months post-TBI, we will defer adjudication of the claim until we obtain evidence of your neurological disorder at least 3 months post-TBI. If a finding of disability still is not possible at that time, we will again defer adjudication of the claim until we obtain evidence at least 6 months after your TBI. N. What are coma and persistent vegetative state, and how do we evaluate them under 111.20? Coma is a state of unconsciousness in which a child does not exhibit a sleep/ wake cycle, and is unable to perceive or respond to external stimuli. Children who do not fully emerge from coma may progress into persistent vegetative state (PVS). PVS is a condition of partial arousal in which a child may have a low level of consciousness but is still unable to react to external stimuli. In contrast to coma, a child in a PVS retains sleep/wake cycles and may exhibit some key lower brain functions, such as spontaneous movement, opening and moving eyes, and grimacing. Coma or PVS may result from a TBI, a nontraumatic insult to the brain (such as a vascular insult, infection, or brain VerDate Sep<11>2014 16:44 Jun 30, 2016 Jkt 238001 tumor), or a neurodegenerative or metabolic disorder. Medically induced comas should be considered under the section pertaining to the underlying reason the coma was medically induced and not under this section. O. What is multiple sclerosis, and how do we evaluate it under 111.21? 1. Multiple sclerosis (MS) is a chronic, inflammatory, degenerative disorder that damages the myelin sheath surrounding the nerve fibers in the brain and spinal cord. The damage disrupts the normal transmission of nerve impulses within the brain and between the brain and other parts of the body causing impairment in muscle coordination, strength, balance, sensation, and vision. There are several forms of MS, ranging from slightly to highly aggressive. Milder forms generally involve acute attacks (exacerbations) with partial or complete recovery from signs and symptoms (remissions). Aggressive forms generally exhibit a steady progression of signs and symptoms with few or no remissions. The effects of all forms vary from child to child. 2. We evaluate your signs and symptoms, such as flaccidity, spasticity, spasms, incoordination, imbalance, tremor, physical fatigue, muscle weakness, dizziness, tingling, and numbness when we determine your ability to stand up, balance, walk, or perform fine and gross motor movements, such as using your arms, hands, and fingers. If you have a vision impairment resulting from your MS, we may evaluate that impairment under the special senses body system, 102.00. P. What are motor neuron disorders, and how do we evaluate them under 111.22? Motor neuron disorders are progressive neurological disorders that destroy the cells that control voluntary muscle activity, such as walking, breathing, swallowing, and speaking. The most common motor neuron disorders in children are progressive bulbar palsy and spinal muscular dystrophy syndromes. We evaluate the effects of these disorders on motor functioning or bulbar and neuromuscular functioning. Q. How do we consider symptoms of fatigue in these listings? Fatigue is one of the most common and limiting symptoms of some neurological disorders, such as multiple sclerosis and myasthenia gravis. These disorders may result in physical fatigue (lack of muscle strength) or mental fatigue (decreased awareness or attention). When we evaluate your fatigue, we will consider the intensity, persistence, and effects of fatigue on your functioning. This may include information such as the clinical and laboratory data and other objective evidence concerning your neurological deficit, a description of fatigue considered characteristic of your disorder, and information about your functioning. We consider the effects of physical fatigue on your ability to stand up, balance, walk, or perform fine and gross motor movements using the criteria described in 111.00D. R. How do we evaluate your neurological disorder when it does not meet one of these listings? 1. If your neurological disorder does not meet the criteria of any of these listings, we must also consider whether your PO 00000 Frm 00078 Fmt 4700 Sfmt 4700 impairment(s) meets the criteria of a listing in another body system. If you have a severe medically determinable impairment(s) that does not meet a listing, we will determine whether your impairment(s) medically equals a listing. See § 416.926 of this chapter. 2. If your impairment(s) does not meet or medically equal a listing, we will consider whether your impairment(s) functionally equals the listings. See § 416.926a of this chapter. 3. We use the rules in § 416.994a of this chapter when we decide whether you continue to be disabled. 111.01 Category of Impairments, Neurological Disorders 111.02 Epilepsy, documented by a detailed description of a typical seizure and characterized by A or B: A. Generalized tonic-clonic seizures (see 111.00F1a), occurring at least once a month for at least 3 consecutive months (see 111.00F4) despite adherence to prescribed treatment (see 111.00C); or B. Dyscognitive seizures (see 111.00F1b) or absence seizures (see 111.00F1c), occurring at least once a week for at least 3 consecutive months (see 111.00F4) despite adherence to prescribed treatment (see 111.00C). 111.03 [Reserved] 111.04 Vascular insult to the brain, characterized by disorganization of motor function in two extremities (see 111.00D1), resulting in an extreme limitation (see 111.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities, persisting for at least 3 consecutive months after the insult. 111.05 Benign brain tumors, characterized by disorganization of motor function in two extremities (see 111.00D1), resulting in an extreme limitation (see 111.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities. 111.06 [Reserved] 111.07 Cerebral palsy, characterized by disorganization of motor function in two extremities (see 111.00D1), resulting in an extreme limitation (see 111.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities. 111.08 Spinal cord disorders, characterized by A or B: A. Complete loss of function, as described in 111.00J2, persisting for 3 consecutive months after the disorder (see 111.00J4); or B. Disorganization of motor function in two extremities (see 111.00D1), resulting in an extreme limitation (see 111.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities persisting for 3 consecutive months after the disorder (see 111.00J4). 111.09 Communication impairment, associated with documented neurological disorder and one of the following: A. Documented speech deficit that significantly affects (see 111.00K1) the clarity and content of the speech; or B. Documented comprehension deficit resulting in ineffective verbal communication (see 111.00K2) for age; or E:\FR\FM\01JYR1.SGM 01JYR1 asabaliauskas on DSK3SPTVN1PROD with RULES Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Rules and Regulations C. Impairment of hearing as described under the criteria in 102.10 or 102.11. 111.10 [Reserved] 111.11 [Reserved] 111.12 Myasthenia gravis, characterized by A or B despite adherence to prescribed treatment for at least 3 months (see 111.00C): A. Disorganization of motor function in two extremities (see 111.00D1), resulting in an extreme limitation (see 111.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities; or B. Bulbar and neuromuscular dysfunction (see 111.00E), resulting in: 1. One myasthenic crisis requiring mechanical ventilation; or 2. Need for supplemental enteral nutrition via a gastrostomy or parenteral nutrition via a central venous catheter. 111.13 Muscular dystrophy, characterized by disorganization of motor function in two extremities (see 111.00D1), resulting in an extreme limitation (see 111.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities. 111.14 Peripheral neuropathy, characterized by disorganization of motor function in two extremities (see 111.00D1), resulting in an extreme limitation (see 111.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities. 111.15 [Reserved] 111.16 [Reserved] 111.17 Neurodegenerative disorders of the central nervous system, such as Juvenileonset Huntington’s disease and Friedreich’s ataxia, characterized by disorganization of motor function in two extremities (see 111.00D1), resulting in an extreme limitation (see 111.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities. 111.18 Traumatic brain injury, characterized by disorganization of motor function in two extremities (see 111.00D1), resulting in an extreme limitation (see 111.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities, persisting for at least 3 consecutive months after the injury. 111.19 [Reserved] 111.20 Coma or persistent vegetative state, persisting for at least 1 month. 111.21 Multiple sclerosis, characterized by disorganization of motor function in two extremities (see 111.00D1), resulting in an extreme limitation (see 111.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities. 111.22 Motor neuron disorders, characterized by A or B: A. Disorganization of motor function in two extremities (see 111.00D1), resulting in an extreme limitation (see 111.00D2) in the ability to stand up from a seated position, balance while standing or walking, or use the upper extremities; or B. Bulbar and neuromuscular dysfunction (see 111.00E), resulting in: 1. Acute respiratory failure requiring invasive mechanical ventilation; or VerDate Sep<11>2014 16:44 Jun 30, 2016 Jkt 238001 2. Need for supplemental enteral nutrition via a gastrostomy or parenteral nutrition via a central venous catheter. [FR Doc. 2016–15306 Filed 6–30–16; 8:45 am] BILLING CODE 4191–02–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 101 [Docket No. FDA–2015–D–1839] The Food and Drug Administration’s Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a guidance for industry entitled ‘‘FDA’s Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels: Guidance for Industry.’’ The guidance explains to manufacturers of conventional foods and dietary supplements our policy on determining the amount to declare on the nutrition label for certain nutrients and dietary ingredients that are present in a small amount. SUMMARY: The guidance is available on July 1, 2016. Submit either electronic or written comments on FDA guidances at any time. ADDRESSES: You may submit comments as follows: DATES: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that PO 00000 Frm 00079 Fmt 4700 Sfmt 4700 43061 identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2015–D–1839. Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http:// www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of E:\FR\FM\01JYR1.SGM 01JYR1

Agencies

[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)]
[Rules and Regulations]
[Pages 43048-43061]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15306]


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SOCIAL SECURITY ADMINISTRATION

20 CFR Part 404

[Docket No. SSA-2006-0140]
RIN 0960-AF35


Revised Medical Criteria for Evaluating Neurological Disorders

AGENCY: Social Security Administration.

ACTION: Final rule.

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SUMMARY: We are revising the criteria in the Listing of Impairments 
(listings) that we use to evaluate disability claims involving 
neurological disorders in adults and children under titles II and XVI 
of the Social Security Act (Act). These revisions reflect our program 
experience; advances in medical knowledge, treatment, and methods of 
evaluating neurological disorders; comments we received from medical 
experts and the public at an outreach policy conference; responses to 
an advance notice of proposed rulemaking (ANPRM); and public comments 
we received in response to a Notice of Proposed Rulemaking (NPRM) and a 
Federal Register notice that reopened the NPRM comment period.

DATES: This rule is effective September 29, 2016.

FOR FURTHER INFORMATION CONTACT: Cheryl A. Williams, Office of 
Disability Policy, 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:

Background

    We are making final the rule for evaluating neurological disorders 
that we proposed in an NPRM published in the Federal Register on 
February 25, 2014 (79 FR 10636). In the preamble to the NPRM, we 
discussed the revisions to our current rule for the neurological

[[Page 43049]]

body system and our reasons for proposing those revisions. To the 
extent that we are adopting the proposed rule as published, we are not 
repeating that information here; interested readers may refer to the 
NPRM preamble. We incorporated into the final rule the portions of 
Social Security Ruling (SSR) 87-6, ``Titles II and XVI: The Role of 
Prescribed Treatment in the Evaluation of Epilepsy'' that continue to 
be relevant to the treatment of epilepsy. As part of the publication of 
this final rule, we are rescinding SSR 87-6. We also respond to public 
comments on the NPRM and explain what changes we are making based on 
those comments in the ``Public Comments on the NPRM'' section of the 
preamble.

Why are we revising the listings for evaluating neurological disorders?

    We are comprehensively revising the listings for evaluating 
neurological disorders to update the medical criteria, provide 
additional methods of evaluating neurological disorders, provide more 
information on how we evaluate neurological disorders, make other 
changes that reflect our program experience, and address adjudicator 
questions. We last comprehensively revised the listings for the 
neurological disorders body system in a final rule published on 
December 6, 1985.\1\ We have made only a few changes since then to meet 
program purposes.\2\
---------------------------------------------------------------------------

    \1\ 50 FR 50068.
    \2\ On December 12, 1990, we raised the IQ limit in 11.07A, 
111.02B1, 111.07B1, and 111.08B2 from 69 to 70 (55 FR 51204). We 
published a final rule adding section 11.00F for traumatic brain 
injury on August 21, 2000 (65 FR 50746); made technical revisions to 
most of the body systems on April 24, 2002 (67 FR 20018), which 
included some changes to the neurological body system; revised 
listing 11.10 for Amyotrophic lateral sclerosis (ALS) on August 82, 
2003 (68 FR 51689); moved the listings for malignant brain tumors to 
the body system for malignant neoplastic diseases on November 15, 
2004 (69 FR 67018); and made a technical correction in listing 
111.09 on March 24, 2011 (76 FR 16531).
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Summary of Public Comments on the NPRM

    In the NPRM, we provided the public with a 60-day comment period 
that ended on April 28, 2014. We reopened the comment period for 30 
days on May 1, 2014 (70 FR 24634). The last of the two comment periods 
closed on June 2, 2014. We received and posted 2,103 public comments 
during the initial period for public comments on the NPRM, and received 
and posted an additional 921 when we extended the NPRM comment period. 
We also received and posted 55 comments when we initially made the 
public aware of our efforts to update this rule, when we published the 
ANPRM. The comments came from members of the public, medical 
professionals, national medical organizations, advocacy groups, 
disability examiners and other adjudicators, and a national association 
representing disability examiners in the State agencies that make 
disability determinations for us.
    The majority of the comments was repetitive and expressed support 
of or agreement with identical recommendations submitted by a few 
national organizations. For example, we received just over 1,100 
comments that repeated, or were in support of recommendations submitted 
by a few Huntington's disease organizations; approximately 800 comments 
that repeated, or were in support of recommendations submitted by 
various headache organizations; and approximately 350 repeat comments 
that were in support of recommendations from various Parkinson's 
disease organizations.
    In general, the recommendations and concerns raised by the majority 
of public commenters were very similar or identical. We received 
several comments suggesting that we create separate listings for 
various neurological disorders that we address in one comment below. 
Some commenters noted provisions with which they agreed and did not 
make suggestions for changes in those provisions. For example, over 300 
comments were testimonials from commenters sharing their personal 
experience with various neurological disorders. Approximately 300 
comments were outside the scope of the neurological NPRM, several of 
those were relevant to other body system disorders; we shared those 
comments with the appropriate body systems policy teams for 
consideration. We did not summarize or respond to comments that were in 
agreement with, or outside the scope of the neurological NPRM. We 
addressed repetitive comments that raised identical issues as one 
comment.
    We carefully considered all of the relevant comments we received 
and we responded to all of the significant issues raised by the 
commenters that were within the scope of this rule. We provide our 
reasons for adopting or not adopting the comment recommendations in our 
responses below.

General Comments

    Comment: Several commenters suggested that we create separate 
listings for various neurological disorders, such as migraine, cluster 
headaches and other severe headache disorders, fetal alcohol syndrome, 
cervical dystonias, atypical facial pain, and trigeminal neuralgia. One 
commenter expressed opposition to creating a separate listing for 
migraine headaches because the symptoms are too subjective. Other 
commenters suggested adding several neurological disorders to specific 
listings.
    Response: We did not adopt these comments. While we do not have 
listings for every neurological condition, we are able to evaluate 
unlisted neurological disorders in several ways under our sequential 
evaluation process. We will determine whether your impairment medically 
equals a listing. If your impairment does not medically equal the 
criteria of a listing, you may or may not have the residual functional 
capacity to perform your past relevant work or adjust to other work 
that exists in significant numbers in the national economy, which we 
determine at the fourth and, if necessary, the fifth steps of the 
sequential evaluation process. As we work on the next iteration of 
revisions to the neurological rule, we will consider the suggestions 
for adding new listings and will consider comments expressing 
opposition to adding certain new listings.
    Comment: We received a number of comments related to how we 
evaluate migraines and other chronic headache disorders. As we 
mentioned in the previous comment, several commenters asked that we 
recognize migraines as a disabling impairment and suggested we create a 
specific listing. Other commenters suggested listing criteria for us to 
consider. One commenter raised concerns about evaluating chronic 
headache disorders because of the subjective nature of the disorders.
    Response: We acknowledge the commenters' concerns. We realize it is 
appropriate to provide impairment-specific guidance on how we evaluate 
migraines and other chronic headache disorders. We will address these 
concerns in training to ensure all adjudicators know how to establish 
migraine and other chronic headache disorders as medically determinable 
impairments (MDIs). Once we establish the existence of an MDI(s), we 
follow the remaining steps in the sequential evaluation process (See 
Sec. Sec.  404.1520, 416.920, and 416.924). As noted in the response 
above to the comments about creating additional listings, we are able 
to evaluate unlisted neurological disorders in several ways under our 
sequential evaluation process.
    Comment: We received several comments expressing concern that the 
proposed functional criteria for determining disability in individuals 
with Huntington's disease (HD) and

[[Page 43050]]

Parkinson's disease still rely on the presence of physical limitations 
and do not adequately address the common non-physical manifestations of 
these diseases. The commenters suggested we include the mental criteria 
from the mental body system in the neurological disorders body system 
to evaluate the mental aspects of neurological disorders in the absence 
of physical limitations commonly seen in HD and in Parkinson's disease. 
They indicated the proposed criteria should include criteria specific 
to mental functioning in order to address the full range of symptoms 
often experienced by people who suffer with HD and Parkinson's disease. 
The commenters also suggested that the proposed introductory text 
sections where we discuss HD and Parkinson's disease direct 
adjudicators beyond listing 12.02 to expand to the entire mental body 
system, as appropriate, when they need to evaluate mental symptoms 
associated with neurological disorders.
    Response: We partially adopted this comment. For program purposes, 
we consider all impairments under all applicable body systems as part 
of our disability evaluation. In the listings, we describe each of the 
major body systems impairments we consider severe enough to be 
disabling, and we list requirements that demonstrate a level of 
severity and duration consistent with the definition of disability set 
by Congress under the Act. We evaluate the person's impairment(s) under 
the most appropriate body system(s). We recognize that neurological 
disorders may co-occur with impairments we evaluate in other body 
systems; however, we intend the listings in this final rule to address 
only neurological disorders and the complications from those disorders. 
When only mental aspects of neurological disorders are present in the 
absence of physical limitations commonly seen in HD and Parkinson's 
disease, we evaluate those limitations under the appropriate mental 
disorders body system listings. However, when mental aspects of 
neurological disorders are present and co-occur with the physical 
limitations of these disorders, we evaluate limitations in physical and 
mental functioning under the neurological listings. In response to this 
and similar comments, we provided additional guidance in the 
introductory text explaining how we evaluate mental disorders under 
these listings.
    We modified our functional criteria and severity rating scale to 
address the common mental aspects of neurological disorders. Our intent 
in the new functional criteria for adults is to provide a way to 
evaluate impairments and determine disability appropriately, even when 
those impairments are difficult to evaluate based on medical criteria 
alone. With functional criteria, we can evaluate the functional impact 
associated with any neurological impairment in broad areas of physical 
and mental functioning. The four areas of mental functioning are 
understanding, remembering, or applying information; interacting with 
others; concentrating, persisting, or maintaining pace; and adapting or 
managing oneself. For example, a person with a neurological disorder 
may demonstrate a limitation in the ability to walk (as addressed under 
the physical functioning criterion). He or she may also have a mental 
impairment resulting from the neurological disorder, which is 
demonstrated by a limitation in the ability to concentrate.
    Comment: A commenter stated that the definition of social 
functioning in proposed section 11.00G3 should not focus solely on 
limitations caused by physical ailments. The commenter suggested that 
the social functioning criteria should include interpersonal 
interactions, as well as non-physical symptoms such as irritability, 
aggression, and perseveration.
    Response: We adopted this comment. We mentioned in the previous 
comment we modified our functional criteria to focus on the common 
mental aspects of neurological disorders. We also changed the criterion 
from ``social functioning'' to ``interacting with others'' to be 
consistent with the way mental functions are described in the 
Diagnostic and Statistical Manual of Mental Disorders, Fifth 
Edition.\3\
---------------------------------------------------------------------------

    \3\ American Psychiatric Association: Diagnostic and Statistical 
Manual of Mental Disorders, Fifth Edition, Arlington, VA, American 
Psychiatric Association, 2013.
---------------------------------------------------------------------------

    Comment: Several commenters noted that proposed section 11.00C 
states, ``Medical research shows that these neurological conditions may 
improve after a period of treatment.'' The commenters pointed out this 
statement is false and we should correct it because Parkinson's disease 
never improves.
    Response: We adopted this comment. It was not our intent to 
indicate in listing 11.06 that Parkinson's disease itself may improve 
with treatment, as the disease is progressive. We removed the 
statement.
    Comment: Several commenters asked that we revise proposed section 
11.00K to clarify that motor and non-motor symptoms can be equally 
disabling in Parkinsonian syndromes, and to reflect that symptoms can 
fluctuate significantly from hour to hour and minute to minute, often 
making job performance in a professional environment very difficult.
    Response: We partially adopted this comment. We agree that non-
motor symptoms can be as disabling as motor symptoms in Parkinsonian 
syndromes. However, limitations resulting from non-motor symptoms are 
highly variable and we evaluate them on a case-by-case basis. The new 
functional criteria enable adjudicators to evaluate non-motor symptoms 
associated with Parkinsonian syndromes under listing 11.06B. We mention 
that neurological disorders may manifest in a combination of 
limitations in physical and mental functioning in the adult section, 
11.00G. We will also provide guidance in training to adjudicators about 
the variable manifestations of neurological disorders, such as 
Parkinsonian syndrome.
    Comment: One commenter expressed disappointment that the revised 
epilepsy listing does not include any discussion of how to ``deal with 
claimants who suffer from a mix of tonic-clonic and dyscognitive 
seizures.'' The commenter stated that ``although the revised listing 
explicitly acknowledges that individuals may suffer from a mix of 
tonic-clonic and dyscognitive seizures,\4\ there is no guidance as to 
how to evaluate a claimant experiencing both types of seizures.''
---------------------------------------------------------------------------

    \4\ See NPRM 11.00H(4)(c).
---------------------------------------------------------------------------

    Response: We do not agree with the commenter. In section 11.00H4c, 
we provide guidance on how to count dyscognitive seizures that progress 
into generalized tonic-clonic seizures. However, we do not believe that 
it is possible to address every permutation of the dyscognitive and 
tonic-clonic mixed seizure types. The signs and symptoms of such 
seizure types will vary from person to person. Adjudicators evaluate 
limitations caused by mixed seizures on a case-by-case basis.
    Comment: One commenter was pleased that we included a more detailed 
explanation for the term ``marked'' in 11.00G2 but was concerned that 
this definition relied on the term ``seriously,'' as in ``interfere 
seriously'' and ``seriously limit,'' which we did not define. This 
commenter believed that not defining the term ``seriously,'' while 
repeatedly relying on it to define the term ``marked,'' creates a 
significant ambiguity in the listings. The commenter was concerned that 
adjudicators will apply the term ``marked'' inconsistently unless we

[[Page 43051]]

include a definition for the term ``seriously.''
    Response: We partially adopted this comment. In the modified final 
section 11.00D of the introductory text, we include criteria for how to 
establish disorganization of motor function, descriptions for how to 
evaluate those criteria, and a definition of an extreme limitation in 
disorganization of motor function. If we do not find that a person is 
disabled on the basis of disorganization of motor function alone, as 
explained in 11.00D, we will find that the person's neurological 
disorder is incompatible with the ability to do any gainful activity if 
it results in marked limitation in physical functioning and marked 
limitation in one of four areas of mental functioning. In the modified 
final section 11.00G of the introductory text, we provide definitions 
for marked limitations drawn from our currently used definitions in 
section 7.00G4 of the listing of impairments for hematological 
disorders and section 1.00B of the listing of impairments for 
musculoskeletal disorders. We also provide descriptions of the 
considerations for physical and mental functioning in 11.00G2 and 
11.00G3.
    Comment: One commenter suggested that we not remove the 
intelligence quotient (IQ) requirement from the neurological listings, 
as the commenter believes it is the best indicator of mental 
capability.
    Response: We did not adopt this comment. As we explained in the 
preamble to the NPRM, we are removing the criterion of an IQ score from 
our neurological listings because advances in medical knowledge of 
cerebral palsy (for adults and children), epilepsy (for children), 
spinal cord insults (for children), and our program experience indicate 
that an IQ score does not provide the best measure of limitations in 
cognitive functioning associated with these disorders. Therefore, it 
may not indicate listing-level severity under the neurological listings 
and would be more appropriately used to evaluate mental disorders under 
our mental disorders body system.
    Comment: One commenter expressed that scales rating function into 
categories such as ``mild,'' ``moderate,'' and ``severe,'' are clearly 
subjective on the part of the rater and their meaningfulness is 
questionable.
    Response: The word ``severe'' in the disability program separates 
step 2 from step 3 in the sequential evaluation process that we use to 
evaluate a person's physical or mental impairment or combination of 
impairments. If we find at step 2 that a person does not have a 
``severe'' medically determinable impairment (MDI) or combination of 
MDIs that meet the duration requirement, we will find the person is not 
disabled. If we find at step 2 that the person has a ``severe'' MDI or 
combination of MDIs, we will continue evaluating the impairment(s) at 
step 3 of the sequential evaluation process. (See Sec. Sec.  
404.1520(a), 416.920(a) and 416.924(a).) With respect to the terms, 
``mild'' and ``moderate,'' we have used those terms in a five-point 
rating scale in the mental disorders body system (consisting of none, 
mild, moderate, marked, and extreme) since 1985 (Sec. Sec.  404.1520a 
and 416.920a). We have also used the terms ``marked'' and ``extreme'' 
limitation in childhood functional equivalence policy (Sec. Sec.  
416.926a). Such scales and ratings continue to be standard medical 
practice, and continue to be effective for evaluating degrees of 
impairment-related limitation(s). Moreover, in the modified final 
introductory text (11.00D2, 11.00G2, and 11.02D2), we include guidance 
for our adjudicators on the meaning and use of these terms.
    Comment: One commenter said a significant feature of the proposed 
new criteria is that we will presume individuals (with many different 
neurological disorders) are disabled if they are unable to stand from a 
sitting position and are not presently working. The commenter noted 
that it appears obvious from casual observation that many individuals 
successfully work in a wide variety of different sedentary positions, 
such as Wal-Mart greeter, office worker, and physician. Because 
significant numbers of these individuals work on a regular basis in the 
national economy, it is quite easy for a lay observer to think it 
inappropriate for the Social Security Administration to presume that 
all individuals unable to stand are also unable to work.
    Response: We did not adopt this comment. As we explain in 11.00D2a, 
an inability to stand up from a seated position means that, once 
seated, you are unable to stand and maintain an upright position 
without the risk of falling unless you have the assistance of another 
person or the use of an assistive device, such as a walker, two 
crutches, or two canes. The severity of such a limitation is set at a 
standard much higher than that applicable to a person who is able to do 
sedentary work; it thereby constitutes an inability to do any gainful 
activity in the national economy.
    Comment: One commenter suggested that when referring to spinal cord 
insults we use the term ``spinal cord disorders'' instead of ``spinal 
cord insults.''
    Response: We agree with the commenter and adopted this comment.
    Comment: Some commenters asked how we would evaluate adherence to 
prescribed treatment for epilepsy patients when we removed the 
requirement for serum drug levels, particularly for patients prescribed 
newer antiepileptic drugs.
    Response: We describe how we consider adherence to prescribed 
treatment under 11.00C. We consider whether you have taken medications 
or followed other treatment procedures as prescribed by a physician for 
three consecutive months. We no longer require serum drug levels. When 
we last revised the listings in 1985, blood drug levels were strong 
indicators for prescribed treatment compliance because therapeutic 
ranges had been established for antiepileptic drugs (AEDs) and the 
ranges were often noted on laboratory results. Many newer AEDs do not 
have established therapeutic levels, which makes lab results difficult 
for our adjudicators to interpret. We removed the requirement for 
obtaining blood drug levels to address this adjudicative issue and to 
simplify evaluation of seizures that satisfy the listing criteria. 
However, we will continue to consider blood drug levels available in 
the evidence in the context of all evidence in the case record.

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

    The Act authorizes us to make rules and regulations and to 
establish necessary and appropriate procedures to implement them.\5\
---------------------------------------------------------------------------

    \5\ 42 U.S.C. 405(a), 902(a)(5), and 1383(d)(1).
---------------------------------------------------------------------------

When will we begin to use this final rule?

    We will begin to use this final rule on its effective date. We will 
continue to use the current listings until the date the final rule 
becomes effective. We will apply the final rule to new applications 
filed on or after the effective date of the final rule and to claims 
that are pending on or after the effective date.\6\
---------------------------------------------------------------------------

    \6\ This means that we will use the final rule on and after 
their effective date in any case in which we make a determination or 
decision. We expect that Federal courts will review the 
Commissioner's final decisions using the rule that were in effect at 
the time we issued the decisions. If a court reverses the 
Commissioner's final decision and remands a case for further 
administrative proceedings after the effective date of the final 
rule, we will apply the final rule to the entire period at issue in 
the decision we make after the court's remand.

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[[Page 43052]]

How long will this final rule be effective?

    This final rule will remain in effect for 5 years after the date it 
becomes effective, unless we extend it, or revise and issue it again.
Regulatory Procedures

Executive Order 12866, as Supplemented by Executive Order 13563

    We consulted with the Office of Management and Budget (OMB) and 
determined that this final rule meets the criteria for a significant 
regulatory action under Executive Order 12866, as supplemented by 
Executive Order 13563. Therefore, OMB reviewed it.

Regulatory Flexibility Act

    We certify that this final rule will not have a significant 
economic impact on a substantial number of small entities because it 
affects only individuals. Therefore, the Regulatory Flexibility Act, as 
amended, does not require us to prepare a regulatory flexibility 
analysis.

Paperwork Reduction Act

    These rules do not create any new or affect any existing 
collections and, therefore, do not require OMB approval under the 
Paperwork Reduction Act.

(Catalog of Federal Domestic Assistance Program Nos. 96.001, Social 
Security--Disability Insurance; 96.002, Social Security-- Retirement 
Insurance; 96.004, Social Security--Survivors Insurance; and 96.006, 
Supplemental Security Income).

List of Subjects in 20 CFR Part 404

    Administrative practice and procedure, Blind, Disability benefits, 
Old-age, Survivors, and Disability Insurance, Reporting and 
recordkeeping requirements, Social Security.

Carolyn W. Colvin,
Acting Commissioner of Social Security.

    For the reasons set out in the preamble, we are amending 20 CFR 
part 404, subpart P as set forth below:

PART 404--FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE 
(1950-)

Subpart P--Determining Disability and Blindness

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 appendix 1 to subpart P of part 404 as follows:
0
a. Revise item 12 of the introductory text before part A;
0
b. Amend part A by revising the body system name for section 11.00 in 
the table of contents;
0
c. In section 1.00 of part A, revise the introduction to paragraph K;
0
d. Revise section 11.00 of part A;
0
e. In section 12.00 of part A, revise paragraph D10, listing 12.01, 
listing 12.09E, and listing 12.09I;
0
f. Amend part B by revising the body system name for section 111.00 in 
the table of contents;
0
g. In section 101.00 of part B, revise the last sentence of paragraph 
B1;
0
h. In section 101.00 of part B, revise the last sentence of paragraph 
B1 and paragraph K; and
0
i. Revise section 111.00 of part B to read as follows:

APPENDIX 1 TO SUBPART P OF PART 404--LISTING OF IMPAIRMENTS

* * * * *
    12. Neurological Disorders (11.00 and 111.00): September 29, 
2021.
* * * * *
Part A
* * * * *
    11.00 Neurological Disorders
* * * * *
    1.00 Musculoskeletal System
* * * * *
    K. Disorders of the spine, listed in 1.04, result in limitations 
because of distortion of the bony and ligamentous architecture of 
the spine and associated impingement on nerve roots (including the 
cauda equina) or spinal cord. Such impingement on nerve tissue may 
result from a herniated nucleus pulposus, spinal stenosis, 
arachnoiditis, or other miscellaneous conditions.
* * * * *
11.00 NEUROLOGICAL DISORDERS
    A. Which neurological disorders do we evaluate under these 
listings? We evaluate epilepsy, amyotrophic lateral sclerosis, coma 
or persistent vegetative state (PVS), and neurological disorders 
that cause disorganization of motor function, bulbar and 
neuromuscular dysfunction, communication impairment, or a 
combination of limitations in physical and mental functioning. We 
evaluate neurological disorders that may manifest in a combination 
of limitations in physical and mental functioning. For example, if 
you have a neurological disorder that causes mental limitations, 
such as Huntington's disease or early-onset Alzheimer's disease, 
which may limit executive functioning (e.g., regulating attention, 
planning, inhibiting responses, decision-making), we evaluate your 
limitations using the functional criteria under these listings (see 
11.00G). Under this body system, we evaluate the limitations 
resulting from the impact of the neurological disease process 
itself. If your neurological disorder results in only mental 
impairment or if you have a co-occurring mental condition that is 
not caused by your neurological disorder (for example, dementia), we 
will evaluate your mental impairment under the mental disorders body 
system, 12.00.
    B. What evidence do we need to document your neurological 
disorder?
    1. We need both medical and non-medical evidence (signs, 
symptoms, and laboratory findings) to assess the effects of your 
neurological disorder. Medical evidence should include your medical 
history, examination findings, relevant laboratory tests, and the 
results of imaging. Imaging refers to medical imaging techniques, 
such as x-ray, computerized tomography (CT), magnetic resonance 
imaging (MRI), and electroencephalography (EEG). The imaging must be 
consistent with the prevailing state of medical knowledge and 
clinical practice as the proper technique to support the evaluation 
of the disorder. In addition, the medical evidence may include 
descriptions of any prescribed treatment and your response to it. We 
consider non-medical evidence such as statements you or others make 
about your impairments, your restrictions, your daily activities, or 
your efforts to work.
    2. We will make every reasonable effort to obtain the results of 
your laboratory and imaging evidence. When the results of any of 
these tests are part of the existing evidence in your case record, 
we will evaluate the test results and all other relevant evidence. 
We will not purchase imaging, or other diagnostic tests, or 
laboratory tests that are complex, may involve significant risk, or 
that are invasive. We will not routinely purchase tests that are 
expensive or not readily available.
    C. How do we consider adherence to prescribed treatment in 
neurological disorders? In 11.02 (Epilepsy), 11.06 (Parkinsonian 
syndrome), and 11.12 (Myasthenia gravis), we require that 
limitations from these neurological disorders exist despite 
adherence to prescribed treatment. ``Despite adherence to prescribed 
treatment'' means that you have taken medication(s) or followed 
other treatment procedures for your neurological disorder(s) as 
prescribed by a physician for three consecutive months but your 
impairment continues to meet the other listing requirements despite 
this treatment. You may receive your treatment at a health care 
facility that you visit regularly, even if you do not see the same 
physician on each visit.
    D. What do we mean by disorganization of motor function?
    1. Disorganization of motor function means interference, due to 
your neurological disorder, with movement of two extremities; i.e., 
the lower extremities, or upper extremities (including fingers, 
wrists, hands, arms, and shoulders). By two extremities we mean both 
lower extremities, or both upper extremities, or one upper extremity 
and one lower extremity. All listings in this body system, except 
for 11.02 (Epilepsy), 11.10 (Amyotrophic lateral sclerosis), and 
11.20 (Coma and persistent vegetative state), include criteria for 
disorganization of motor function that results in an extreme 
limitation in your ability to:

[[Page 43053]]

    a. Stand up from a seated position; or
    b. Balance while standing or walking; or
    c. Use the upper extremities (including fingers, wrists, hands, 
arms, and shoulders).
    2. Extreme limitation means the inability to stand up from a 
seated position, maintain balance in a standing position and while 
walking, or use your upper extremities to independently initiate, 
sustain, and complete work-related activities. The assessment of 
motor function depends on the degree of interference with standing 
up; balancing while standing or walking; or using the upper 
extremities (including fingers, hands, arms, and shoulders).
    a. Inability to stand up from a seated position means that once 
seated you are unable to stand and maintain an upright position 
without the assistance of another person or the use of an assistive 
device, such as a walker, two crutches, or two canes.
    b. Inability to maintain balance in a standing position means 
that you are unable to maintain an upright position while standing 
or walking without the assistance of another person or an assistive 
device, such as a walker, two crutches, or two canes.
    c. Inability to use your upper extremities means that you have a 
loss of function of both upper extremities (including fingers, 
wrists, hands, arms, and shoulders) that very seriously limits your 
ability to independently initiate, sustain, and complete work-
related activities involving fine and gross motor movements. 
Inability to perform fine and gross motor movements could include 
not being able to pinch, manipulate, and use your fingers; or not 
being able to use your hands, arms, and shoulders to perform gross 
motor movements, such as handling, gripping, grasping, holding, 
turning, and reaching; or not being able to engage in exertional 
movements such a lifting, carrying, pushing, and pulling.
    E. How do we evaluate communication impairments under these 
listings? We must have a description of a recent comprehensive 
evaluation including all areas of communication, performed by an 
acceptable medical source, to document a communication impairment 
associated with a neurological disorder. A communication impairment 
may occur when a medically determinable neurological impairment 
results in dysfunction in the parts of the brain responsible for 
speech and language. We evaluate communication impairments 
associated with neurological disorders under 11.04A, 11.07C, or 
11.11B. We evaluate communication impairments due to non-
neurological disorders under 2.09.
    1. Under 11.04A, we need evidence documenting that your central 
nervous system vascular accident or insult (CVA) and sensory or 
motor aphasia have resulted in ineffective speech or communication. 
Ineffective speech or communication means there is an extreme 
limitation in your ability to understand or convey your message in 
simple spoken language resulting in your inability to demonstrate 
basic communication skills, such as following one-step commands or 
telling someone about your basic personal needs without assistance.
    2. Under 11.07C, we need evidence documenting that your cerebral 
palsy has resulted in significant interference in your ability to 
speak, hear, or see. We will find you have ``significant 
interference'' in your ability to speak, hear, or see if your signs, 
such as aphasia, strabismus, or sensorineural hearing loss, 
seriously limit your ability to communicate on a sustained basis.
    3. Under 11.11B, we need evidence documenting that your post-
polio syndrome has resulted in the inability to produce intelligible 
speech.
    F. What do we mean by bulbar and neuromuscular dysfunction? The 
bulbar region of the brain is responsible for controlling the bulbar 
muscles in the throat, tongue, jaw, and face. Bulbar and 
neuromuscular dysfunction refers to weakness in these muscles, 
resulting in breathing, swallowing, and speaking impairments. 
Listings 11.11 (Post-polio syndrome), 11.12 (Myasthenia gravis), and 
11.22 (Motor neuron disorders other than ALS) include criteria for 
evaluating bulbar and neuromuscular dysfunction. If your 
neurological disorder has resulted in a breathing disorder, we may 
evaluate that condition under the respiratory system, 3.00.
    G. How do we evaluate limitations in physical and mental 
functioning under these listings?
    1. Neurological disorders may manifest in a combination of 
limitations in physical and mental functioning. We consider all 
relevant information in your case record to determine the effects of 
your neurological disorder on your physical and mental functioning. 
To satisfy the requirement described under 11.00G, your neurological 
disorder must result in a marked limitation in physical functioning 
and a marked limitation in at least one of four areas of mental 
functioning: Understanding, remembering, or applying information; 
interacting with others; concentrating, persisting, or maintaining 
pace; or adapting or managing oneself. If your neurological disorder 
results in an extreme limitation in at least one of the four areas 
of mental functioning, or results in marked limitation in at least 
two of the four areas of mental functioning, but you do not have at 
least a marked limitation in your physical functioning, we will 
consider whether your condition meets or medically equals one of the 
mental disorders body system listings, 12.00.
    2. Marked Limitation. To satisfy the requirements of the 
functional criteria, your neurological disorder must result in a 
marked limitation in physical functioning and a marked limitation in 
one of the four areas of mental functioning (see 11.00G3). Although 
we do not require the use of such a scale, ``marked'' would be the 
fourth point on a five-point scale consisting of no limitation, mild 
limitation, moderate limitation, marked limitation, and extreme 
limitation. We consider the nature and overall degree of 
interference with your functioning. The term ``marked'' does not 
require that you must be confined to bed, hospitalized, or in a 
nursing home.
    a. Marked limitation and physical functioning. For this 
criterion, a marked limitation means that, due to the signs and 
symptoms of your neurological disorder, you are seriously limited in 
the ability to independently initiate, sustain, and complete work-
related physical activities (see 11.00G3). You may have a marked 
limitation in your physical functioning when your neurological 
disease process causes persistent or intermittent symptoms that 
affect your abilities to independently initiate, sustain, and 
complete work-related activities, such as standing, balancing, 
walking, using both upper extremities for fine and gross movements, 
or results in limitations in using one upper and one lower 
extremity. The persistent and intermittent symptoms must result in a 
serious limitation in your ability to do a task or activity on a 
sustained basis. We do not define ``marked'' by a specific number of 
different physical activities or tasks that demonstrate your 
ability, but by the overall effects of your neurological symptoms on 
your ability to perform such physical activities on a consistent and 
sustained basis. You need not be totally precluded from performing a 
function or activity to have a marked limitation, as long as the 
degree of limitation seriously limits your ability to independently 
initiate, sustain, and complete work-related physical activities.
    b. Marked limitation and mental functioning. For this criterion, 
a marked limitation means that, due to the signs and symptoms of 
your neurological disorder, you are seriously limited in the ability 
to function independently, appropriately, effectively, and on a 
sustained basis in work settings (see 11.03G3). We do not define 
``marked'' by a specific number of mental activities, such as: The 
number of activities that demonstrate your ability to understand, 
remember, and apply information; the number of tasks that 
demonstrate your ability to interact with others; a specific number 
of tasks that demonstrate you are able to concentrate, persist or 
maintain pace; or a specific number of tasks that demonstrate you 
are able to manage yourself. You may have a marked limitation in 
your mental functioning when several activities or functions are 
impaired, or even when only one is impaired. You need not be totally 
precluded from performing an activity to have a marked limitation, 
as long as the degree of limitation seriously limits your ability to 
function independently, appropriately, and effectively on a 
sustained basis, and complete work-related mental activities.
    3. Areas of physical and mental functioning.
    a. Physical functioning. Examples of this criterion include 
specific motor abilities, such as independently initiating, 
sustaining, and completing the following activities: Standing up 
from a seated position, balancing while standing or walking, or 
using both your upper extremities for fine and gross movements (see 
11.00D). Physical functioning may also include functions of the body 
that support motor abilities, such as the abilities to see, breathe, 
and swallow (see 11.00E and 11.00F). Examples of when your 
limitation in seeing, breathing, or swallowing may, on its own, rise 
to a ``marked'' limitation include: Prolonged and uncorrectable 
double vision causing difficulty with balance; prolonged difficulty 
breathing requiring the use of a prescribed

[[Page 43054]]

assistive breathing device, such as a portable continuous positive 
airway pressure machine; or repeated instances, occurring at least 
weekly, of aspiration without causing aspiration pneumonia. 
Alternatively, you may have a combination of limitations due to your 
neurological disorder that together rise to a ``marked'' limitation 
in physical functioning. We may also find that you have a ``marked'' 
limitation in this area if, for example, your symptoms, such as pain 
or fatigue (see 11.00T), as documented in your medical record, and 
caused by your neurological disorder or its treatment, seriously 
limit your ability to independently initiate, sustain, and complete 
these work-related motor functions, or the other physical functions 
or physiological processes that support those motor functions. We 
may also find you seriously limited in an area if, while you retain 
some ability to perform the function, you are unable to do so 
consistently and on a sustained basis. The limitation in your 
physical functioning must last or be expected to last at least 12 
months. These examples illustrate the nature of physical 
functioning. We do not require documentation of all of the examples.
    b. Mental functioning.
    (i) Understanding, remembering, or applying information. This 
area of mental functioning refers to the abilities to learn, recall, 
and use information to perform work activities. Examples include: 
Understanding and learning terms, instructions, procedures; 
following one- or two-step oral instructions to carry out a task; 
describing work activity to someone else; asking and answering 
questions and providing explanations; recognizing a mistake and 
correcting it; identifying and solving problems; sequencing multi-
step activities; and using reason and judgment to make work-related 
decisions. These examples illustrate the nature of this area of 
mental functioning. We do not require documentation of all of the 
examples.
    (ii) Interacting with others. This area of mental functioning 
refers to the abilities to relate to and work with supervisors, co-
workers, and the public. Examples include: Cooperating with others; 
asking for help when needed; handling conflicts with others; stating 
your own point of view; initiating or sustaining conversation; 
understanding and responding to social cues (physical, verbal, 
emotional); responding to requests, suggestions, criticism, 
correction, and challenges; and keeping social interactions free of 
excessive irritability, sensitivity, argumentativeness, or 
suspiciousness. These examples illustrate the nature of this area of 
mental functioning. We do not require documentation of all of the 
examples.
    (iii) Concentrating, persisting, or maintaining pace. This area 
of mental functioning refers to the abilities to focus attention on 
work activities and to stay on-task at a sustained rate. Examples 
include: Initiating and performing a task that you understand and 
know how to do; working at an appropriate and consistent pace; 
completing tasks in a timely manner; ignoring or avoiding 
distractions while working; changing activities or work settings 
without being disruptive; working close to or with others without 
interrupting or distracting them; sustaining an ordinary routine and 
regular attendance at work; and working a full day without needing 
more than the allotted number or length of rest periods during the 
day. These examples illustrate the nature of this area of mental 
functioning. We do not require documentation of all of the examples.
    (iv) Adapting or managing oneself. This area of mental 
functioning refers to the abilities to regulate emotions, control 
behavior, and maintain well-being in a work setting. Examples 
include: Responding to demands; adapting to changes; managing your 
psychologically based symptoms; distinguishing between acceptable 
and unacceptable work performance; setting realistic goals; making 
plans for yourself independently of others; maintaining personal 
hygiene and attire appropriate to a work setting; and being aware of 
normal hazards and taking appropriate precautions. These examples 
illustrate the nature of this area of mental functioning. We do not 
require documentation of all of the examples.
    4. Signs and symptoms of your disorder and the effects of 
treatment.
    a. We will consider your signs and symptoms and how they affect 
your ability to function in the work place. When we evaluate your 
functioning, we will consider whether your signs and symptoms are 
persistent or intermittent, how frequently they occur and how long 
they last, their intensity, and whether you have periods of 
exacerbation and remission.
    b. We will consider the effectiveness of treatment in improving 
the signs, symptoms, and laboratory findings related to your 
neurological disorder, as well as any aspects of treatment that may 
interfere with your ability to function. We will consider, for 
example: The effects of medications you take (including side 
effects); the time-limited efficacy of some medications; the 
intrusiveness, complexity, and duration of your treatment (for 
example, the dosing schedule or need for injections); the effects of 
treatment, including medications, therapy, and surgery, on your 
functioning; the variability of your response to treatment; and any 
drug interactions.
    H. What is epilepsy, and how do we evaluate it under 11.02?
    1. Epilepsy is a pattern of recurrent and unprovoked seizures 
that are manifestations of abnormal electrical activity in the 
brain. There are various types of generalized and ``focal'' or 
partial seizures. However, psychogenic nonepileptic seizures and 
pseudoseizures are not epileptic seizures for the purpose of 11.02. 
We evaluate psychogenic seizures and pseudoseizures under the mental 
disorders body system, 12.00. In adults, the most common potentially 
disabling seizure types are generalized tonic-clonic seizures and 
dyscognitive seizures (formerly complex partial seizures).
    a. Generalized tonic-clonic seizures are characterized by loss 
of consciousness accompanied by a tonic phase (sudden muscle tensing 
causing the person to lose postural control) followed by a clonic 
phase (rapid cycles of muscle contraction and relaxation, also 
called convulsions). Tongue biting and incontinence may occur during 
generalized tonic-clonic seizures, and injuries may result from 
falling.
    b. Dyscognitive seizures are characterized by alteration of 
consciousness without convulsions or loss of muscle control. During 
the seizure, blank staring, change of facial expression, and 
automatisms (such as lip smacking, chewing or swallowing, or 
repetitive simple actions, such as gestures or verbal utterances) 
may occur. During its course, a dyscognitive seizure may progress 
into a generalized tonic-clonic seizure (see 11.00H1a).
    2. Description of seizure. We require at least one detailed 
description of your seizures from someone, preferably a medical 
professional, who has observed at least one of your typical 
seizures. If you experience more than one type of seizure, we 
require a description of each type.
    3. Serum drug levels. We do not require serum drug levels; 
therefore, we will not purchase them. However, if serum drug levels 
are available in your medical records, we will evaluate them in the 
context of the other evidence in your case record.
    4. Counting seizures. The period specified in 11.02A, B, or C 
cannot begin earlier than one month after you began prescribed 
treatment. The required number of seizures must occur within the 
period we are considering in connection with your application or 
continuing disability review. When we evaluate the frequency of your 
seizures, we also consider your adherence to prescribed treatment 
(see 11.00C). When we determine the number of seizures you have had 
in the specified period, we will:
    a. Count multiple seizures occurring in a 24-hour period as one 
seizure.
    b. Count status epilepticus (a continuous series of seizures 
without return to consciousness between seizures) as one seizure.
    c. Count a dyscognitive seizure that progresses into a 
generalized tonic-clonic seizure as one generalized tonic-clonic 
seizure.
    d. We do not count seizures that occur during a period when you 
are not adhering to prescribed treatment without good reason. When 
we determine that you had good reason for not adhering to prescribed 
treatment, we will consider your physical, mental, educational, and 
communicative limitations (including any language barriers). We will 
consider you to have good reason for not following prescribed 
treatment if, for example, the treatment is very risky for you due 
to its consequences or unusual nature, or if you are unable to 
afford prescribed treatment that you are willing to accept, but for 
which no free community resources are available. We will follow 
guidelines found in our policy, such as Sec. Sec.  404.1530(c) and 
416.930(c) of this chapter, when we determine whether you have a 
good reason for not adhering to prescribed treatment.
    e. We do not count psychogenic nonepileptic seizures or 
pseudoseizures under 11.02. We evaluate these seizures under the 
mental disorders body system, 12.00.
    5. Electroencephalography (EEG) testing. We do not require EEG 
test results; therefore,

[[Page 43055]]

we will not purchase them. However, if EEG test results are 
available in your medical records, we will evaluate them in the 
context of the other evidence in your case record.
    I. What is vascular insult to the brain, and how do we evaluate 
it under 11.04?
    1. Vascular insult to the brain (cerebrum, cerebellum, or 
brainstem), commonly referred to as stroke or cerebrovascular 
accident (CVA), is brain cell death caused by an interruption of 
blood flow within or leading to the brain, or by a hemorrhage from a 
ruptured blood vessel or aneurysm in the brain. If you have a vision 
impairment resulting from your vascular insult, we may evaluate that 
impairment under the special senses body system, 2.00.
    2. We need evidence of sensory or motor aphasia that results in 
ineffective speech or communication under 11.04A (see 11.00E). We 
may evaluate your communication impairment under listing 11.04C if 
you have marked limitation in physical functioning and marked 
limitation in one of the four areas of mental functioning.
    3. We generally need evidence from at least 3 months after the 
vascular insult to evaluate whether you have disorganization of 
motor functioning under 11.04B, or the impact that your disorder has 
on your physical and mental functioning under 11.04C. In some cases, 
evidence of your vascular insult is sufficient to allow your claim 
within 3 months post-vascular insult. If we are unable to allow your 
claim within 3 months after your vascular insult, we will defer 
adjudication of the claim until we obtain evidence of your 
neurological disorder at least 3 months post-vascular insult.
    J. What are benign brain tumors, and how do we evaluate them 
under 11.05? Benign brain tumors are noncancerous (nonmalignant) 
abnormal growths of tissue in or on the brain that invade healthy 
brain tissue or apply pressure on the brain or cranial nerves. We 
evaluate their effects on your functioning as discussed in 11.00D 
and 11.00G. We evaluate malignant brain tumors under the cancer body 
system in 13.00. If you have a vision impairment resulting from your 
benign brain tumor, we may evaluate that impairment under the 
special senses body system, 2.00.
    K. What is Parkinsonian syndrome, and how do we evaluate it 
under 11.06? Parkinsonian syndrome is a term that describes a group 
of chronic, progressive movement disorders resulting from loss or 
decline in the function of dopamine-producing brain cells. Dopamine 
is a neurotransmitter that regulates muscle movement throughout the 
body. When we evaluate your Parkinsonian syndrome, we will consider 
your adherence to prescribed treatment (see 11.00C).
    L. What is cerebral palsy, and how do we evaluate it under 
11.07?
    1. Cerebral palsy (CP) is a term that describes a group of 
static, nonprogressive disorders caused by abnormalities within the 
brain that disrupt the brain's ability to control movement, muscle 
coordination, and posture. The resulting motor deficits manifest 
very early in a person's development, with delayed or abnormal 
progress in attaining developmental milestones. Deficits may become 
more obvious as the person grows and matures over time.
    2. We evaluate your signs and symptoms, such as ataxia, 
spasticity, flaccidity, athetosis, chorea, and difficulty with 
precise movements when we determine your ability to stand up, 
balance, walk, or perform fine and gross motor movements. We will 
also evaluate your signs, such as dysarthria and apraxia of speech, 
and receptive and expressive language problems when we determine 
your ability to communicate.
    3. We will consider your other impairments or signs and symptoms 
that develop secondary to the disorder, such as post-impairment 
syndrome (a combination of pain, fatigue, and weakness due to muscle 
abnormalities); overuse syndromes (repetitive motion injuries); 
arthritis; abnormalities of proprioception (perception of the 
movements and position of the body); abnormalities of stereognosis 
(perception and identification of objects by touch); learning 
problems; anxiety; and depression.
    M. What are spinal cord disorders, and how do we evaluate them 
under 11.08?
    1. Spinal cord disorders may be congenital or caused by injury 
to the spinal cord. Motor signs and symptoms of spinal cord 
disorders include paralysis, flaccidity, spasticity, and weakness.
    2. Spinal cord disorders with complete loss of function (11.08A) 
addresses spinal cord disorders that result in a complete lack of 
motor, sensory, and autonomic function of the affected part(s) of 
the body.
    3. Spinal cord disorders with disorganization of motor function 
(11.08B) addresses spinal cord disorders that result in less than a 
complete loss of function of the affected part(s) of the body, 
reducing, but not eliminating, motor, sensory, and autonomic 
function.
    4. When we evaluate your spinal cord disorder, we generally need 
evidence from at least 3 months after your symptoms began in order 
to evaluate your disorganization of motor function. In some cases, 
evidence of your spinal cord disorder may be sufficient to allow 
your claim within 3 months after the spinal cord disorder. If the 
medical evidence demonstrates total cord transection causing a loss 
of motor and sensory functions below the level of injury, we will 
not wait 3 months but will make the allowance decision immediately.
    N. What is multiple sclerosis, and how do we evaluate it under 
11.09?
    1. Multiple sclerosis (MS) is a chronic, inflammatory, 
degenerative disorder that damages the myelin sheath surrounding the 
nerve fibers in the brain and spinal cord. The damage disrupts the 
normal transmission of nerve impulses within the brain and between 
the brain and other parts of the body, causing impairment in muscle 
coordination, strength, balance, sensation, and vision. There are 
several forms of MS, ranging from mildly to highly aggressive. 
Milder forms generally involve acute attacks (exacerbations) with 
partial or complete recovery from signs and symptoms (remissions). 
Aggressive forms generally exhibit a steady progression of signs and 
symptoms with few or no remissions. The effects of all forms vary 
from person to person.
    2. We evaluate your signs and symptoms, such as flaccidity, 
spasticity, spasms, incoordination, imbalance, tremor, physical 
fatigue, muscle weakness, dizziness, tingling, and numbness when we 
determine your ability to stand up, balance, walk, or perform fine 
and gross motor movements. When determining whether you have 
limitations of physical and mental functioning, we will consider 
your other impairments or signs and symptoms that develop secondary 
to the disorder, such as fatigue; visual loss; trouble sleeping; 
impaired attention, concentration, memory, or judgment; mood swings; 
and depression. If you have a vision impairment resulting from your 
MS, we may evaluate that impairment under the special senses body 
system, 2.00.
    O. What is amyotrophic lateral sclerosis, and how do we evaluate 
it under 11.10? Amyotrophic lateral sclerosis (ALS) is a type of 
motor neuron disorder that rapidly and progressively attacks the 
nerve cells responsible for controlling voluntary muscles. We 
establish ALS under 11.10 when you have a documented diagnosis of 
ALS. We require documentation based on generally accepted methods 
consistent with the prevailing state of medical knowledge and 
clinical practice. We require laboratory testing to establish the 
diagnosis when the clinical findings of upper and lower motor neuron 
disease are not present in three or more regions. 
Electrophysiological studies, such as nerve conduction velocity 
studies and electromyography (EMG), may support your diagnosis of 
ALS; however, we will not purchase these studies.
    P. What are neurodegenerative disorders of the central nervous 
system, such as Huntington's disease, Friedreich's ataxia, and 
spinocerebellar degeneration, and how do we evaluate them under 
11.17? Neurodegenerative disorders of the central nervous system are 
disorders characterized by progressive and irreversible degeneration 
of neurons or their supporting cells. Over time, these disorders 
impair many of the body's motor, cognitive, and other mental 
functions. We consider neurodegenerative disorders of the central 
nervous system under 11.17 that we do not evaluate elsewhere in 
section 11.00, such as Huntington's disease (HD), Friedreich's 
ataxia, spinocerebellar degeneration, Creutzfeldt-Jakob disease 
(CJD), progressive supranuclear palsy (PSP), early-onset Alzheimer's 
disease, and frontotemporal dementia (Pick's disease). When these 
disorders result in solely cognitive and other mental function 
effects, we will evaluate the disorder under the mental disorder 
listings.
    Q. What is traumatic brain injury, and how do we evaluate it 
under 11.18?
    1. Traumatic brain injury (TBI) is damage to the brain resulting 
from skull fracture, collision with an external force leading to a 
closed head injury, or penetration by an object that enters the 
skull and makes contact with brain tissue. We evaluate TBI that 
results in coma or persistent vegetative state (PVS) under 11.20.
    2. We generally need evidence from at least 3 months after the 
TBI to evaluate whether you have disorganization of motor function 
under 11.18A or the impact that your

[[Page 43056]]

disorder has on your physical and mental functioning under 11.18B. 
In some cases, evidence of your TBI is sufficient to determine 
disability within 3 months post-TBI. If we are unable to allow your 
claim within 3 months post-TBI, we will defer adjudication of the 
claim until we obtain evidence of your neurological disorder at 
least 3 months post-TBI. If a finding of disability still is not 
possible at that time, we will again defer adjudication of the claim 
until we obtain evidence at least 6 months after your TBI.
    R. What are coma and persistent vegetative state, and how do we 
evaluate them under 11.20? Coma is a state of unconsciousness in 
which a person does not exhibit a sleep/wake cycle, and is unable to 
perceive or respond to external stimuli. People who do not fully 
emerge from coma may progress into a persistent vegetative state 
(PVS). PVS is a condition of partial arousal in which a person may 
have a low level of consciousness but is still unable to react to 
external stimuli. In contrast to coma, a person in a PVS retains 
sleep/wake cycles and may exhibit some key lower brain functions, 
such as spontaneous movement, opening and moving eyes, and 
grimacing. Coma or PVS may result from TBI, a nontraumatic insult to 
the brain (such as a vascular insult, infection, or brain tumor), or 
a neurodegenerative or metabolic disorder. Medically induced comas 
are not considered under 11.20 and should be considered under the 
section pertaining to the underlying reason the coma was medically 
induced and not under this section.
    S. What are motor neuron disorders, other than ALS, and how do 
we evaluate them under 11.22? Motor neuron disorders such as 
progressive bulbar palsy, primary lateral sclerosis (PLS), and 
spinal muscular atrophy (SMA) are progressive neurological disorders 
that destroy the cells that control voluntary muscle activity, such 
as walking, breathing, swallowing, and speaking. We evaluate the 
effects of these disorders on motor functioning, bulbar and 
neuromuscular functioning, oral communication, or limitations in 
physical and mental functioning.
    T. How do we consider symptoms of fatigue in these listings? 
Fatigue is one of the most common and limiting symptoms of some 
neurological disorders, such as multiple sclerosis, post-polio 
syndrome, and myasthenia gravis. These disorders may result in 
physical fatigue (lack of muscle strength) or mental fatigue 
(decreased awareness or attention). When we evaluate your fatigue, 
we will consider the intensity, persistence, and effects of fatigue 
on your functioning. This may include information such as the 
clinical and laboratory data and other objective evidence concerning 
your neurological deficit, a description of fatigue considered 
characteristic of your disorder, and information about your 
functioning. We consider the effects of physical fatigue on your 
ability to stand up, balance, walk, or perform fine and gross motor 
movements using the criteria described in 11.00D. We consider the 
effects of physical and mental fatigue when we evaluate your 
physical and mental functioning described in 11.00G.
    U. How do we evaluate your neurological disorder when it does 
not meet one of these listings?
    1. If your neurological disorder does not meet the criteria of 
any of these listings, we must also consider whether your 
impairment(s) meets the criteria of a listing in another body 
system. If you have a severe medically determinable impairment(s) 
that does not meet a listing, we will determine whether your 
impairment(s) medically equals a listing. See Sec. Sec.  404.1526 
and 416.926 of this chapter.
    2. If your impairment(s) does not meet or medically equal the 
criteria of a listing, you may or may not have the residual 
functional capacity to perform your past relevant work or adjust to 
other work that exists in significant numbers in the national 
economy, which we determine at the fourth and, if necessary, the 
fifth steps of the sequential evaluation process in Sec. Sec.  
404.1520 and 416.920 of this chapter.
    3. We use the rules in Sec. Sec.  404.1594 and 416.994 of this 
chapter, as appropriate, when we decide whether you continue to be 
disabled.

11.01 Category of Impairments, Neurological Disorders

    11.02 Epilepsy, documented by a detailed description of a 
typical seizure and characterized by A, B, C, or D:
    A. Generalized tonic-clonic seizures (see 11.00H1a), occurring 
at least once a month for at least 3 consecutive months (see 
11.00H4) despite adherence to prescribed treatment (see 11.00C); or
    B. Dyscognitive seizures (see 11.00H1b), occurring at least once 
a week for at least 3 consecutive months (see 11.00H4) despite 
adherence to prescribed treatment (see 11.00C); or
    C. Generalized tonic-clonic seizures (see 11.00H1a), occurring 
at least once every 2 months for at least 4 consecutive months (see 
11.00H4) despite adherence to prescribed treatment (see 11.00C); and 
a marked limitation in one of the following:
    1. Physical functioning (see 11.00G3a); or
    2. Understanding, remembering, or applying information (see 
11.00G3b(i)); or
    3. Interacting with others (see 11.00G3b(ii)); or
    4. Concentrating, persisting, or maintaining pace (see 
11.00G3b(iii)); or
    5. Adapting or managing oneself (see 11.00G3b(iv)); or
    D. Dyscognitive seizures (see 11.00H1b), occurring at least once 
every 2 weeks for at least 3 consecutive months (see 11.00H4) 
despite adherence to prescribed treatment (see 11.00C); and a marked 
limitation in one of the following:
    1. Physical functioning (see 11.00G3a); or
    2. Understanding, remembering, or applying information (see 
11.00G3b(i)); or
    3. Interacting with others (see 11.00G3b(ii)); or
    4. Concentrating, persisting, or maintaining pace (see 
11.00G3b(iii)); or
    5. Adapting or managing oneself (see 11.00G3b(iv)).
    11.03 [Reserved]
    11.04 Vascular insult to the brain, characterized by A, B, or C:
    A. Sensory or motor aphasia resulting in ineffective speech or 
communication (see 11.00E1) persisting for at least 3 consecutive 
months after the insult; or
    B. Disorganization of motor function in two extremities (see 
11.00D1), resulting in an extreme limitation (see 11.00D2) in the 
ability to stand up from a seated position, balance while standing 
or walking, or use the upper extremities, persisting for at least 3 
consecutive months after the insult; or
    C. Marked limitation (see 11.00G2) in physical functioning (see 
11.00G3a) and in one of the following areas of mental functioning, 
both persisting for at least 3 consecutive months after the insult:
    1. Understanding, remembering, or applying information (see 
11.00G3b(i)); or
    2. Interacting with others (see 11.00G3b(ii)); or
    3. Concentrating, persisting, or maintaining pace (see 
11.00G3b(iii)); or
    4. Adapting or managing oneself (see 11.00G3b(iv)).
    11.05 Benign brain tumors, characterized by A or B:
    A. Disorganization of motor function in two extremities (see 
11.00D1), resulting in an extreme limitation (see 11.00D2) in the 
ability to stand up from a seated position, balance while standing 
or walking, or use the upper extremities; or
    B. Marked limitation (see 11.00G2) in physical functioning (see 
11.00G3a), and in one of the following:
    1. Understanding, remembering, or applying information (see 
11.00G3b(i)); or
    2. Interacting with others (see 11.00G3b(ii)); or
    3. Concentrating, persisting, or maintaining pace (see 
11.00G3b(iii)); or
    4. Adapting or managing oneself (see 11.00G3b(iv)).
    11.06 Parkinsonian syndrome, characterized by A or B despite 
adherence to prescribed treatment for at least 3 consecutive months 
(see 11.00C):
    A. Disorganization of motor function in two extremities (see 
11.00D1), resulting in an extreme limitation (see 11.00D2) in the 
ability to stand up from a seated position, balance while standing 
or walking, or use the upper extremities; or
    B. Marked limitation (see 11.00G2) in physical functioning (see 
11.00G3a), and in one of the following:
    1. Understanding, remembering, or applying information (see 
11.00G3b(i)); or
    2. Interacting with others (see 11.00G3b(ii)); or
    3. Concentrating, persisting, or maintaining pace (see 
11.00G3b(iii)); or
    4. Adapting or managing oneself (see 11.00G3b(iv)).
    11.07 Cerebral palsy, characterized by A, B, or C:
    A. Disorganization of motor function in two extremities (see 
11.00D1), resulting in an extreme limitation (see 11.00D2) in the 
ability to stand up from a seated position, balance while standing 
or walking, or use the upper extremities; or
    B. Marked limitation (see 11.00G2) in physical functioning (see 
11.00G3a), and in one of the following:
    1. Understanding, remembering, or applying information (see 
11.00G3b(i)); or

[[Page 43057]]

    2. Interacting with others (see 11.00G3b(ii)); or
    3. Concentrating, persisting, or maintaining pace (see 
11.00G3b(iii)); or
    4. Adapting or managing oneself (see 11.00G3b(iv)); or
    C. Significant interference in communication due to speech, 
hearing, or visual deficit (see 11.00E2).
    11.08 Spinal cord disorders, characterized by A, B, or C:
    A. Complete loss of function, as described in 11.00M2, 
persisting for 3 consecutive months after the disorder (see 
11.00M4); or
    B. Disorganization of motor function in two extremities (see 
11.00D1), resulting in an extreme limitation (see 11.00D2) in the 
ability to stand up from a seated position, balance while standing 
or walking, or use the upper extremities persisting for 3 
consecutive months after the disorder (see 11.00M4); or
    C. Marked limitation (see 11.00G2) in physical functioning (see 
11.00G3a) and in one of the following areas of mental functioning, 
both persisting for 3 consecutive months after the disorder (see 
11.00M4):
    1. Understanding, remembering, or applying information (see 
11.00G3b(i)); or
    2. Interacting with others (see 11.00G3b(ii)); or
    3. Concentrating, persisting, or maintaining pace (see 
11.00G3b(iii)); or
    4. Adapting or managing oneself (see 11.00G3b(iv)).
    11.09 Multiple sclerosis, characterized by A or B:
    A. Disorganization of motor function in two extremities (see 
11.00D1), resulting in an extreme limitation (see 11.00D2) in the 
ability to stand up from a seated position, balance while standing 
or walking, or use the upper extremities; or
    B. Marked limitation (see 11.00G2) in physical functioning (see 
11.00G3a), and in one of the following:
    1. Understanding, remembering, or applying information (see 
11.00G3b(i)); or
    2. Interacting with others (see 11.00G3b(ii)); or
    3. Concentrating, persisting, or maintaining pace (see 
11.00G3b(iii)); or
    4. Adapting or managing oneself (see 11.00G3b(iv)).
    11.10 Amyotrophic lateral sclerosis (ALS) established by 
clinical and laboratory findings (see 11.00O).
    11.11 Post-polio syndrome, characterized by A, B, C, or D:
    A. Disorganization of motor function in two extremities (see 
11.00D1), resulting in an extreme limitation (see 11.00D2) in the 
ability to stand up from a seated position, balance while standing 
or walking, or use the upper extremities; or
    B. Unintelligible speech (see 11.00E3); or
    C. Bulbar and neuromuscular dysfunction (see 11.00F), resulting 
in:
    1. Acute respiratory failure requiring mechanical ventilation; 
or
    2. Need for supplemental enteral nutrition via a gastrostomy or 
parenteral nutrition via a central venous catheter; or
    D. Marked limitation (see 11.00G2) in physical functioning (see 
11.00G3a), and in one of the following:
    1. Understanding, remembering, or applying information (see 
11.00G3b(i)); or
    2. Interacting with others (see 11.00G3b(ii)); or
    3. Concentrating, persisting, or maintaining pace (see 
11.00G3b(iii)); or
    4. Adapting or managing oneself (see 11.00G3b(iv)).
    11.12 Myasthenia gravis, characterized by A, B, or C despite 
adherence to prescribed treatment for at least 3 months (see 
11.00C):
    A. Disorganization of motor function in two extremities (see 
11.00D1), resulting in an extreme limitation (see 11.00D2) in the 
ability to stand up from a seated position, balance while standing 
or walking, or use the upper extremities; or
    B. Bulbar and neuromuscular dysfunction (see 11.00F), resulting 
in:
    1. One myasthenic crisis requiring mechanical ventilation; or
    2. Need for supplemental enteral nutrition via a gastrostomy or 
parenteral nutrition via a central venous catheter; or
    C. Marked limitation (see 11.00G2) in physical functioning (see 
11.00G3a), and in one of the following:
    1. Understanding, remembering, or applying information (see 
11.00G3b(i)); or
    2. Interacting with others (see 11.00G3b(ii)); or
    3. Concentrating, persisting, or maintaining pace (see 
11.00G3b(iii)); or
    4. Adapting or managing oneself (see 11.00G3b(iv)).
    11.13 Muscular dystrophy, characterized by A or B:
    A. Disorganization of motor function in two extremities (see 
11.00D1), resulting in an extreme limitation (see 11.00D2) in the 
ability to stand up from a seated position, balance while standing 
or walking, or use the upper extremities; or
    B. Marked limitation (see 11.00G2) in physical functioning (see 
11.00G3a), and in one of the following:
    1. Understanding, remembering, or applying information (see 
11.00G3b(i)); or
    2. Interacting with others (see 11.00G3b(ii)); or
    3. Concentrating, persisting, or maintaining pace (see 
11.00G3b(iii)); or
    4. Adapting or managing oneself (see 11.00G3b(iv)).
    11.14 Peripheral neuropathy, characterized by A or B:
    A. Disorganization of motor function in two extremities (see 
11.00D1), resulting in an extreme limitation (see 11.00D2) in the 
ability to stand up from a seated position, balance while standing 
or walking, or use the upper extremities; or
    B. Marked limitation (see 11.00G2) in physical functioning (see 
11.00G3a), and in one of the following:
    1. Understanding, remembering, or applying information (see 
11.00G3b(i)); or
    2. Interacting with others (see 11.00G3b(ii)); or
    3. Concentrating, persisting, or maintaining pace (see 
11.00G3b(iii)); or
    4. Adapting or managing oneself (see 11.00G3b(iv)).
    11.15 [Reserved]
    11.16 [Reserved]
    11.17 Neurodegenerative disorders of the central nervous system, 
such as Huntington's disease, Friedreich's ataxia, and 
spinocerebellar degeneration, characterized by A or B:
    A. Disorganization of motor function in two extremities (see 
11.00D1), resulting in an extreme limitation (see 11.00D2) in the 
ability to stand up from a seated position, balance while standing 
or walking, or use the upper extremities; or
    B. Marked limitation (see 11.00G2) in physical functioning (see 
11.00G3a), and in one of the following:
    1. Understanding, remembering, or applying information (see 
11.00G3b(i)); or
    2. Interacting with others (see 11.00G3b(ii)); or
    3. Concentrating, persisting, or maintaining pace (see 
11.00G3b(iii)); or
    4. Adapting or managing oneself (see 11.00G3b(iv)).
    11.18 Traumatic brain injury, characterized by A or B:
    A. Disorganization of motor function in two extremities (see 
11.00D1), resulting in an extreme limitation (see 11.00D2) in the 
ability to stand up from a seated position, balance while standing 
or walking, or use the upper extremities, persisting for at least 3 
consecutive months after the injury; or
    B. Marked limitation (see 11.00G2) in physical functioning (see 
11.00G3a), and in one of the following areas of mental functioning, 
persisting for at least 3 consecutive months after the injury:
    1. Understanding, remembering, or applying information (see 
11.00G3b(i)); or
    2. Interacting with others (see 11.00G3b(ii)); or
    3. Concentrating, persisting, or maintaining pace (see 
11.00G3b(iii)); or
    4. Adapting or managing oneself (see 11.00G3b(iv)).
    11.19 [Reserved]
    11.20 Coma or persistent vegetative state, persisting for at 
least 1 month.
    11.21 [Reserved]
    11.22 Motor neuron disorders other than ALS, characterized by A, 
B, or C:
    A. Disorganization of motor function in two extremities (see 
11.00D1), resulting in an extreme limitation (see 11.00D2) in the 
ability to stand up from a seated position, balance while standing 
or walking, or use the upper extremities; or
    B. Bulbar and neuromuscular dysfunction (see 11.00F), resulting 
in:
    1. Acute respiratory failure requiring invasive mechanical 
ventilation; or
    2. Need for supplemental enteral nutrition via a gastrostomy or 
parenteral nutrition via a central venous catheter; or
    C. Marked limitation (see 11.00G2) in physical functioning (see 
11.00G3a), and in one of the following:
    1. Understanding, remembering, or applying information (see 
11.00G3b(i)); or
    2. Interacting with others (see 11.00G3b(ii)); or
    3. Concentrating, persisting, or maintaining pace (see 
11.00G3b(iii)); or
    4. Adapting or managing oneself (see 11.00G3b(iv)).
* * * * *
12.00 MENTAL DISORDERS
* * * * *
    D. * * *

[[Page 43058]]

    10. Traumatic brain injury (TBI). In cases involving TBI, follow 
the documentation and evaluation guidelines in 11.00Q.
* * * * *
    12.01 Category of Impairments, Mental Disorders
* * * * *
    12.09 * * *
    E. Peripheral neuropathy. Evaluate under 11.14.
* * * * *
    I. Seizures. Evaluate under 11.02.
* * * * *
    Part B
* * * * *
    111.00 Neurological Disorders
* * * * *
101.00 MUSCULOSKELETAL SYSTEM
* * * * *
    B. Loss of function.
    1. General. * * * We evaluate impairments with neurological 
causes under 111.00, as appropriate.
* * * * *
    K. Disorders of the spine, listed in 101.04, result in 
limitations because of distortion of the bony and ligamentous 
architecture of the spine and associated impingement on nerve roots 
(including the cauda equina) or spinal cord. Such impingement on 
nerve tissue may result from a herniated nucleus pulposus, spinal 
stenosis, arachnoiditis, or other miscellaneous conditions.
* * * * *

111.00 NEUROLOGICAL DISORDERS

    A. Which neurological disorders do we evaluate under these 
listings? We evaluate epilepsy, coma or persistent vegetative state 
(PVS), and neurological disorders that cause disorganization of 
motor function, bulbar and neuromuscular dysfunction, or 
communication impairment. Under this body system, we evaluate the 
limitations resulting from the impact of the neurological disease 
process itself. If you have a neurological disorder(s) that affects 
your physical and mental functioning, we will evaluate your 
impairments under the rules we use to determine functional 
equivalence. If your neurological disorder results in only mental 
impairment or if you have a co-occurring mental condition that is 
not caused by your neurological disorder (for example, Autism 
spectrum disorder), we will evaluate your mental impairment under 
the mental disorders body system, 112.00.
    B. What evidence do we need to document your neurological 
disorder?
    1. We need both medical and non-medical evidence (signs, 
symptoms, and laboratory findings) to assess the effects of your 
neurological disorder. Medical evidence should include your medical 
history, examination findings, relevant laboratory tests, and the 
results of imaging. Imaging refers to medical imaging techniques, 
such as x-ray, computerized tomography (CT), magnetic resonance 
imaging (MRI), and electroencephalography (EEG). The imaging must be 
consistent with the prevailing state of medical knowledge and 
clinical practice as the proper technique to support the evaluation 
of the disorder. In addition, the medical evidence may include 
descriptions of any prescribed treatment and your response to it. We 
consider non-medical evidence such as statements you or others make 
about your impairments, your restrictions, your daily activities, 
or, if you are an adolescent, your efforts to work.
    2. We will make every reasonable effort to obtain the results of 
your laboratory and imaging evidence. When the results of any of 
these tests are part of the existing evidence in your case record, 
we will evaluate the test results and all other relevant evidence. 
We will not purchase imaging, or other diagnostic tests or 
laboratory tests that are complex, may involve significant risk, or 
that are invasive. We will not routinely purchase tests that are 
expensive or not readily available.
    C. How do we consider adherence to prescribed treatment in 
neurological disorders? In 111.02 (Epilepsy) and 111.12 (Myasthenia 
gravis), we require that limitations from these neurological 
disorders exist despite adherence to prescribed treatment. ``Despite 
adherence to prescribed treatment'' means that you have taken 
medication(s) or followed other treatment procedures for your 
neurological disorder(s) as prescribed by a physician for three 
consecutive months but your impairment continues to meet the other 
listing requirements despite this treatment. You may receive your 
treatment at a health care facility that you visit regularly, even 
if you do not see the same physician on each visit.
    D. What do we mean by disorganization of motor function?
    1. Disorganization of motor function means interference, due to 
your neurological disorder, with movement of two extremities; i.e., 
the lower extremities, or upper extremities (including fingers, 
wrists, hands, arms, and shoulders). By two extremities we mean both 
lower extremities, or both upper extremities, or one upper extremity 
and one lower extremity. All listings in this body system, except 
for 111.02 (Epilepsy) and 111.20 (Coma and persistent vegetative 
state), include criteria for disorganization of motor function that 
results in an extreme limitation in your ability to:
    a. Stand up from a seated position; or
    b. Balance while standing or walking; or
    c. Use the upper extremities (e.g., fingers, wrists, hands, 
arms, and shoulders).
    2. Extreme limitation means the inability to stand up from a 
seated position, maintain balance in a standing position and while 
walking, or use your upper extremities to independently initiate, 
sustain, and complete age-appropriate activities. The assessment of 
motor function depends on the degree of interference with standing 
up; balancing while standing or walking; or using the upper 
extremities (including fingers, hands, arms, and shoulders).
    a. Inability to stand up from a seated position means that once 
seated you are unable to stand and maintain an upright position 
without the assistance of another person or the use of an assistive 
device, such as a walker, two crutches, or two canes.
    b. Inability to maintain balance in a standing position means 
that you are unable to maintain an upright position while standing 
or walking without the assistance of another person or an assistive 
device, such as a walker, two crutches, or two canes.
    c. Inability to use your upper extremities means that you have a 
loss of function of both upper extremities (e.g., fingers, wrists, 
hands, arms, and shoulders) that very seriously limits your ability 
to independently initiate, sustain, and complete age- appropriate 
activities involving fine and gross motor movements. Inability to 
perform fine and gross motor movements could include not being able 
to pinch, manipulate, and use your fingers; or not being able to use 
your hands, arms, and shoulders to perform gross motor movements, 
such as handling, gripping, grasping, holding, turning, and 
reaching; or not being able to engage in exertional movements such a 
lifting, carrying, pushing, and pulling.
    3. For children who are not yet able to balance, stand up, or 
walk independently, we consider their function based on assessments 
of limitations in the ability to perform comparable age-appropriate 
activities with the lower and upper extremities, given normal 
developmental milestones. For such children, an extreme level of 
limitation means developmental milestones at less than one-half of 
the child's chronological age.
    E. What do we mean by bulbar and neuromuscular dysfunction? The 
bulbar region of the brain is responsible for controlling the bulbar 
muscles in the throat, tongue, jaw, and face. Bulbar and 
neuromuscular dysfunction refers to weakness in these muscles, 
resulting in breathing, swallowing, and speaking impairments. 
Listings 111.12 (Myasthenia gravis) and 111.22 (Motor neuron 
disorders) include criteria for evaluating bulbar and neuromuscular 
dysfunction. If your neurological disorder has resulted in a 
breathing disorder, we may evaluate that condition under the 
respiratory system, 103.00.
    F. What is epilepsy, and how do we evaluate it under 111.02?
    1. Epilepsy is a pattern of recurrent and unprovoked seizures 
that are manifestations of abnormal electrical activity in the 
brain. There are various types of generalized and ``focal'' or 
partial seizures. In children, the most common potentially disabling 
seizure types are generalized tonic-clonic seizures, dyscognitive 
seizures (formerly complex partial seizures), and absence seizures. 
However, psychogenic nonepileptic seizures and pseudoseizures are 
not epileptic seizures for the purpose of 111.02. We evaluate 
psychogenic seizures and pseudoseizures under the mental disorders 
body system, 112.00.
    a. Generalized tonic-clonic seizures are characterized by loss 
of consciousness accompanied by a tonic phase (sudden muscle tensing 
causing the child to lose postural control) followed by a clonic 
phase (rapid cycles of muscle contraction and relaxation, also 
called convulsions). Tongue biting and incontinence may occur during 
generalized tonic-clonic seizures, and injuries may result from 
falling.
    b. Dyscognitive seizures are characterized by alteration of 
consciousness without

[[Page 43059]]

convulsions or loss of muscle control. During the seizure, blank 
staring, change of facial expression, and automatisms (such as lip 
smacking, chewing or swallowing, or repetitive simple actions, such 
as gestures or verbal utterances) may occur. During its course, a 
dyscognitive seizure may progress into a generalized tonic-clonic 
seizure (see 111.00F1a).
    c. Absence seizures (petit mal) are also characterized by an 
alteration in consciousness, but are shorter than other generalized 
seizures (e.g., tonic-clonic and dyscognitive) seizures, generally 
lasting for only a few seconds rather than minutes. They may present 
with blank staring, change of facial expression, lack of awareness 
and responsiveness, and a sense of lost time after the seizure. An 
aura never precedes absence seizures. Although absence seizures are 
brief, frequent occurrence may limit functioning. This type of 
seizure usually does not occur after adolescence.
    d. Febrile seizures may occur in young children in association 
with febrile illnesses. We will consider seizures occurring during 
febrile illnesses. To meet 111.02, we require documentation of 
seizures during nonfebrile periods and epilepsy must be established.
    2. Description of seizure. We require at least one detailed 
description of your seizures from someone, preferably a medical 
professional, who has observed at least one of your typical 
seizures. If you experience more than one type of seizure, we 
require a description of each type.
    3. Serum drug levels. We do not require serum drug levels; 
therefore, we will not purchase them. However, if serum drug levels 
are available in your medical records, we will evaluate them in the 
context of the other evidence in your case record.
    4. Counting seizures. The period specified in 111.02A or B 
cannot begin earlier than one month after you began prescribed 
treatment. The required number of seizures must occur within the 
period we are considering in connection with your application or 
continuing disability review. When we evaluate the frequency of your 
seizures, we also consider your adherence to prescribed treatment 
(see 111.00C). When we determine the number of seizures you have had 
in the specified period, we will:
    a. Count multiple seizures occurring in a 24-hour period as one 
seizure.
    b. Count status epilepticus (a continuous series of seizures 
without return to consciousness between seizures) as one seizure.
    c. Count a dyscognitive seizure that progresses into a 
generalized tonic-clonic seizure as one generalized tonic-clonic 
seizure.
    d. We do not count seizures that occur during a period when you 
are not adhering to prescribed treatment without good reason. When 
we determine that you had a good reason for not adhering to 
prescribed treatment, we will consider your physical, mental, 
educational, and communicative limitations (including any language 
barriers). We will consider you to have good reason for not 
following prescribed treatment if, for example, the treatment is 
very risky for you due to its consequences or unusual nature, or if 
you are unable to afford prescribed treatment that you are willing 
to accept, but for which no free community resources are available. 
We will follow guidelines found in our policy, such as Sec.  
416.930(c) of this chapter, when we determine whether you have a 
good reason for not adhering to prescribed treatment.
    e. We do not count psychogenic nonepileptic seizures or 
pseudoseizures under 111.02.We evaluate these seizures under the 
mental disorders body system, 112.00.
    5. Electroencephalography (EEG) testing. We do not require EEG 
test results; therefore, we will not purchase them. However, if EEG 
test results are available in your medical records, we will evaluate 
them in the context of the other evidence in your case record.
    G. What is vascular insult to the brain, and how do we evaluate 
it under 111.04?
    1. Vascular insult to the brain (cerebrum, cerebellum, or 
brainstem), commonly referred to as stroke or cerebrovascular 
accident (CVA), is brain cell death caused by an interruption of 
blood flow within or leading to the brain, or by a hemorrhage from a 
ruptured blood vessel or aneurysm in the brain. If you have a vision 
impairment resulting from your vascular insult, we may evaluate that 
impairment under the special senses body system, 102.00.
    2. We generally need evidence from at least 3 months after the 
vascular insult to determine whether you have disorganization of 
motor function under 111.04. In some cases, evidence of your 
vascular insult is sufficient to allow your claim within 3 months 
post-vascular insult. If we are unable to allow your claim within 3 
months after your vascular insult, we will defer adjudication of the 
claim until we obtain evidence of your neurological disorder at 
least 3 months post-vascular insult.
    H. What are benign brain tumors, and how do we evaluate them 
under 111.05? Benign brain tumors are noncancerous (nonmalignant) 
abnormal growths of tissue in or on the brain that invade healthy 
brain tissue or apply pressure on the brain or cranial nerves. We 
evaluate their effects on your functioning as discussed in 111.00D. 
We evaluate malignant brain tumors under the cancer body system in 
113.00. If you have a vision impairment resulting from your benign 
brain tumor, we may evaluate that impairment under the special 
senses body system, 102.00.
    I. What is cerebral palsy, and how do we evaluate it under 
111.07?
    1. Cerebral palsy (CP) is a term that describes a group of 
static, nonprogressive disorders caused by abnormalities within the 
brain that disrupt the brain's ability to control movement, muscle 
coordination, and posture. The resulting motor deficits manifest 
very early in a child's development, with delayed or abnormal 
progress in attaining developmental milestones; deficits may become 
more obvious as the child grows and matures over time.
    2. We evaluate your signs and symptoms, such as ataxia, 
spasticity, flaccidity, athetosis, chorea, and difficulty with 
precise movements when we determine your ability to stand up, 
balance, walk, or perform fine and gross motor movements. We will 
also evaluate your signs, such as dysarthria and apraxia of speech, 
and receptive and expressive language problems when we determine 
your ability to communicate.
    3. We will consider your other impairments or signs and symptoms 
that develop secondary to the disorder, such as post-impairment 
syndrome (a combination of pain, fatigue, and weakness due to muscle 
abnormalities); overuse syndromes (repetitive motion injuries); 
arthritis; abnormalities of proprioception (perception of the 
movements and position of the body); abnormalities of stereognosis 
(perception and identification of objects by touch); learning 
problems; anxiety; and depression.
    J. What are spinal cord disorders, and how do we evaluate them 
under 111.08?
    1. Spinal cord disorders may be congenital or caused by injury 
to the spinal cord. Motor signs and symptoms of spinal cord 
disorders include paralysis, flaccidity, spasticity, and weakness.
    2. Spinal cord disorders with complete loss of function 
(111.08A) addresses spinal cord disorders that result in complete 
lack of motor, sensory, and autonomic function of the affected 
part(s) of the body.
    3. Spinal cord disorders with disorganization of motor function 
(111.08B) addresses spinal cord disorders that result in less than 
complete loss of function of the affected part(s) of the body, 
reducing, but not eliminating, motor, sensory, and autonomic 
function.
    4. When we evaluate your spinal cord disorder, we generally need 
evidence from at least 3 months after your symptoms began in order 
to evaluate your disorganization of motor function. In some cases, 
evidence of your spinal cord disorder may be sufficient to allow 
your claim within 3 months after the spinal cord disorder. If the 
medical evidence demonstrates total cord transection causing a loss 
of motor and sensory functions below the level of injury, we will 
not wait 3 months but will make the allowance decision immediately.
    K. What are communication impairments associated with 
neurological disorders, and how do we evaluate them under 111.09?
    1. Communication impairments result from medically determinable 
neurological disorders that cause dysfunction in the parts of the 
brain responsible for speech and language. Under 111.09, we must 
have recent comprehensive evaluation including all areas of 
affective and effective communication, performed by a qualified 
professional, to document a communication impairment associated with 
a neurological disorder.
    2. Under 111.09A, we need documentation from a qualified 
professional that your neurological disorder has resulted in a 
speech deficit that significantly affects your ability to 
communicate. Significantly affects means that you demonstrate a 
serious limitation in communicating, and a person who is unfamiliar 
with you cannot easily understand or interpret your speech.
    3. Under 111.09B, we need documentation from a qualified 
professional that shows that your neurological disorder has resulted 
in a comprehension deficit that results in ineffective verbal 
communication for your

[[Page 43060]]

age. For the purposes of 111.09B, comprehension deficit means a 
deficit in receptive language. Ineffective verbal communication 
means that you demonstrate serious limitation in your ability to 
communicate orally on the same level as other children of the same 
age and level of development.
    4. Under 111.09C, we need documentation of a neurological 
disorder that has resulted in hearing loss. Your hearing loss will 
be evaluated under listing 102.10 or 102.11.
    5. We evaluate speech deficits due to non-neurological disorders 
under 2.09.
    L. What are neurodegenerative disorders of the central nervous 
system, such as Juvenile-onset Huntington's disease and Friedreich's 
ataxia, and how do we evaluate them under 111.17? Neurodegenerative 
disorders of the central nervous system are disorders characterized 
by progressive and irreversible degeneration of neurons or their 
supporting cells. Over time, these disorders impair many of the 
body's motor or cognitive and other mental functions. We consider 
neurodegenerative disorders of the central nervous system under 
111.17 that we do not evaluate elsewhere in section 111.00, such as 
juvenile-onset Huntington's disease (HD) and Friedreich's ataxia. 
When these disorders result in solely cognitive and other mental 
functional limitations, we will evaluate the disorder under the 
mental disorder listings, 112.00.
    M. What is traumatic brain injury, and how do we evaluate it 
under 111.18?
    1. Traumatic brain injury (TBI) is damage to the brain resulting 
from skull fracture, collision with an external force leading to a 
closed head injury, or penetration by an object that enters the 
skull and makes contact with brain tissue. We evaluate a TBI that 
results in coma or persistent vegetative state (PVS) under 111.20.
    2. We generally need evidence from at least 3 months after the 
TBI to evaluate whether you have disorganization of motor function 
under 111.18. In some cases, evidence of your TBI is sufficient to 
determine disability. If we are unable to allow your claim within 3 
months post-TBI, we will defer adjudication of the claim until we 
obtain evidence of your neurological disorder at least 3 months 
post-TBI. If a finding of disability still is not possible at that 
time, we will again defer adjudication of the claim until we obtain 
evidence at least 6 months after your TBI.
    N. What are coma and persistent vegetative state, and how do we 
evaluate them under 111.20? Coma is a state of unconsciousness in 
which a child does not exhibit a sleep/wake cycle, and is unable to 
perceive or respond to external stimuli. Children who do not fully 
emerge from coma may progress into persistent vegetative state 
(PVS). PVS is a condition of partial arousal in which a child may 
have a low level of consciousness but is still unable to react to 
external stimuli. In contrast to coma, a child in a PVS retains 
sleep/wake cycles and may exhibit some key lower brain functions, 
such as spontaneous movement, opening and moving eyes, and 
grimacing. Coma or PVS may result from a TBI, a nontraumatic insult 
to the brain (such as a vascular insult, infection, or brain tumor), 
or a neurodegenerative or metabolic disorder. Medically induced 
comas should be considered under the section pertaining to the 
underlying reason the coma was medically induced and not under this 
section.
    O. What is multiple sclerosis, and how do we evaluate it under 
111.21?
    1. Multiple sclerosis (MS) is a chronic, inflammatory, 
degenerative disorder that damages the myelin sheath surrounding the 
nerve fibers in the brain and spinal cord. The damage disrupts the 
normal transmission of nerve impulses within the brain and between 
the brain and other parts of the body causing impairment in muscle 
coordination, strength, balance, sensation, and vision. There are 
several forms of MS, ranging from slightly to highly aggressive. 
Milder forms generally involve acute attacks (exacerbations) with 
partial or complete recovery from signs and symptoms (remissions). 
Aggressive forms generally exhibit a steady progression of signs and 
symptoms with few or no remissions. The effects of all forms vary 
from child to child.
    2. We evaluate your signs and symptoms, such as flaccidity, 
spasticity, spasms, incoordination, imbalance, tremor, physical 
fatigue, muscle weakness, dizziness, tingling, and numbness when we 
determine your ability to stand up, balance, walk, or perform fine 
and gross motor movements, such as using your arms, hands, and 
fingers. If you have a vision impairment resulting from your MS, we 
may evaluate that impairment under the special senses body system, 
102.00.
    P. What are motor neuron disorders, and how do we evaluate them 
under 111.22? Motor neuron disorders are progressive neurological 
disorders that destroy the cells that control voluntary muscle 
activity, such as walking, breathing, swallowing, and speaking. The 
most common motor neuron disorders in children are progressive 
bulbar palsy and spinal muscular dystrophy syndromes. We evaluate 
the effects of these disorders on motor functioning or bulbar and 
neuromuscular functioning.
    Q. How do we consider symptoms of fatigue in these listings? 
Fatigue is one of the most common and limiting symptoms of some 
neurological disorders, such as multiple sclerosis and myasthenia 
gravis. These disorders may result in physical fatigue (lack of 
muscle strength) or mental fatigue (decreased awareness or 
attention). When we evaluate your fatigue, we will consider the 
intensity, persistence, and effects of fatigue on your functioning. 
This may include information such as the clinical and laboratory 
data and other objective evidence concerning your neurological 
deficit, a description of fatigue considered characteristic of your 
disorder, and information about your functioning. We consider the 
effects of physical fatigue on your ability to stand up, balance, 
walk, or perform fine and gross motor movements using the criteria 
described in 111.00D.
    R. How do we evaluate your neurological disorder when it does 
not meet one of these listings?
    1. If your neurological disorder does not meet the criteria of 
any of these listings, we must also consider whether your 
impairment(s) meets the criteria of a listing in another body 
system. If you have a severe medically determinable impairment(s) 
that does not meet a listing, we will determine whether your 
impairment(s) medically equals a listing. See Sec.  416.926 of this 
chapter.
    2. If your impairment(s) does not meet or medically equal a 
listing, we will consider whether your impairment(s) functionally 
equals the listings. See Sec.  416.926a of this chapter.
    3. We use the rules in Sec.  416.994a of this chapter when we 
decide whether you continue to be disabled.

111.01 Category of Impairments, Neurological Disorders

    111.02 Epilepsy, documented by a detailed description of a 
typical seizure and characterized by A or B:
    A. Generalized tonic-clonic seizures (see 111.00F1a), occurring 
at least once a month for at least 3 consecutive months (see 
111.00F4) despite adherence to prescribed treatment (see 111.00C); 
or
    B. Dyscognitive seizures (see 111.00F1b) or absence seizures 
(see 111.00F1c), occurring at least once a week for at least 3 
consecutive months (see 111.00F4) despite adherence to prescribed 
treatment (see 111.00C).
    111.03 [Reserved]
    111.04 Vascular insult to the brain, characterized by 
disorganization of motor function in two extremities (see 111.00D1), 
resulting in an extreme limitation (see 111.00D2) in the ability to 
stand up from a seated position, balance while standing or walking, 
or use the upper extremities, persisting for at least 3 consecutive 
months after the insult.
    111.05 Benign brain tumors, characterized by disorganization of 
motor function in two extremities (see 111.00D1), resulting in an 
extreme limitation (see 111.00D2) in the ability to stand up from a 
seated position, balance while standing or walking, or use the upper 
extremities.
    111.06 [Reserved]
    111.07 Cerebral palsy, characterized by disorganization of motor 
function in two extremities (see 111.00D1), resulting in an extreme 
limitation (see 111.00D2) in the ability to stand up from a seated 
position, balance while standing or walking, or use the upper 
extremities.
    111.08 Spinal cord disorders, characterized by A or B:
    A. Complete loss of function, as described in 111.00J2, 
persisting for 3 consecutive months after the disorder (see 
111.00J4); or
    B. Disorganization of motor function in two extremities (see 
111.00D1), resulting in an extreme limitation (see 111.00D2) in the 
ability to stand up from a seated position, balance while standing 
or walking, or use the upper extremities persisting for 3 
consecutive months after the disorder (see 111.00J4).
    111.09 Communication impairment, associated with documented 
neurological disorder and one of the following:
    A. Documented speech deficit that significantly affects (see 
111.00K1) the clarity and content of the speech; or
    B. Documented comprehension deficit resulting in ineffective 
verbal communication (see 111.00K2) for age; or

[[Page 43061]]

    C. Impairment of hearing as described under the criteria in 
102.10 or 102.11.
    111.10 [Reserved]
    111.11 [Reserved]
    111.12 Myasthenia gravis, characterized by A or B despite 
adherence to prescribed treatment for at least 3 months (see 
111.00C):
    A. Disorganization of motor function in two extremities (see 
111.00D1), resulting in an extreme limitation (see 111.00D2) in the 
ability to stand up from a seated position, balance while standing 
or walking, or use the upper extremities; or
    B. Bulbar and neuromuscular dysfunction (see 111.00E), resulting 
in:
    1. One myasthenic crisis requiring mechanical ventilation; or
    2. Need for supplemental enteral nutrition via a gastrostomy or 
parenteral nutrition via a central venous catheter.
    111.13 Muscular dystrophy, characterized by disorganization of 
motor function in two extremities (see 111.00D1), resulting in an 
extreme limitation (see 111.00D2) in the ability to stand up from a 
seated position, balance while standing or walking, or use the upper 
extremities.
    111.14 Peripheral neuropathy, characterized by disorganization 
of motor function in two extremities (see 111.00D1), resulting in an 
extreme limitation (see 111.00D2) in the ability to stand up from a 
seated position, balance while standing or walking, or use the upper 
extremities.
    111.15 [Reserved]
    111.16 [Reserved]
    111.17 Neurodegenerative disorders of the central nervous 
system, such as Juvenile-onset Huntington's disease and Friedreich's 
ataxia, characterized by disorganization of motor function in two 
extremities (see 111.00D1), resulting in an extreme limitation (see 
111.00D2) in the ability to stand up from a seated position, balance 
while standing or walking, or use the upper extremities.
    111.18 Traumatic brain injury, characterized by disorganization 
of motor function in two extremities (see 111.00D1), resulting in an 
extreme limitation (see 111.00D2) in the ability to stand up from a 
seated position, balance while standing or walking, or use the upper 
extremities, persisting for at least 3 consecutive months after the 
injury.
    111.19 [Reserved]
    111.20 Coma or persistent vegetative state, persisting for at 
least 1 month.
    111.21 Multiple sclerosis, characterized by disorganization of 
motor function in two extremities (see 111.00D1), resulting in an 
extreme limitation (see 111.00D2) in the ability to stand up from a 
seated position, balance while standing or walking, or use the upper 
extremities.
    111.22 Motor neuron disorders, characterized by A or B:
    A. Disorganization of motor function in two extremities (see 
111.00D1), resulting in an extreme limitation (see 111.00D2) in the 
ability to stand up from a seated position, balance while standing 
or walking, or use the upper extremities; or
    B. Bulbar and neuromuscular dysfunction (see 111.00E), resulting 
in:
    1. Acute respiratory failure requiring invasive mechanical 
ventilation; or
    2. Need for supplemental enteral nutrition via a gastrostomy or 
parenteral nutrition via a central venous catheter.

[FR Doc. 2016-15306 Filed 6-30-16; 8:45 am]
 BILLING CODE 4191-02-P