# Revised Medical Criteria for Evaluating Mental Disorders and Traumatic Brain Injury

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URL: https://www.frixlaw.com/law-library/documents/fr%3A00-19648

## Record

- **Collection:** Federal Register
- **Document type:** Rule
- **Published:** August 21, 2000
- **Citation:** 65 FR 50746

## Text

SOCIAL SECURITY ADMINISTRATION
20 CFR Parts 404 and 416
[Regulation Nos. 4 and 16]
RIN 0960-AC74
Revised Medical Criteria for Evaluating Mental Disorders and Traumatic Brain Injury

AGENCY:

Social Security Administration.

ACTION:

Final rules.

SUMMARY:

These rules revise our regulations for evaluating mental impairments. They also change some of the provisions of our Listing of Impairments (the Listings) that we use to evaluate mental disorders in adults. We also are adding guidance to the adult neurological listings regarding the evaluation of traumatic brain injury. In addition, the rules make technical changes to the adult digestive listings and the childhood mental disorders listings. We expect that these rules will clarify the intent and purpose of the listings for evaluating mental disorders, and will simplify our adjudication of claims involving mental impairments. These rules also recognize the sometimes unpredictable course of traumatic brain injury, and will improve our adjudication of claims involving traumatic brain injuries.

DATES:

These rules are effective September 20, 2000.

FOR FURTHER INFORMATION CONTACT:

Deborah Barnes, Social Insurance Specialist, Office of Disability, Social Security Administration, 3-B-8 Operations Building, 6401 Security Boulevard, Baltimore, MD 21235-6401, (410) 965-4171, email deborah.barnes@ssa.gov, or TTY (410) 966-5609. For information on eligibility, claiming benefits, or coverage of earnings, call our national toll-free number, 1-800-772-1213 or TTY 1-800-325-0778.

SUPPLEMENTARY INFORMATION:

Background

Title II of the Act provides for the payment of disability benefits to three groups of individuals: Workers insured under the Act; children of insured workers; and widows, widowers, and surviving divorced spouses of insured workers. Title XVI of the Act provides for supplemental security income (SSI) payments on the basis of disability to adults and to children. For individuals claiming title II disability benefits and for adults claiming SSI disability payments, “disability” means the inability to do any substantial gainful activity (SGA). We will consider a child claiming SSI disability payments “disabled” if he or she has an impairment(s) that causes “marked and severe functional limitations.” Under both title II and title XVI, disability must be by reason of a medically determinable physical or mental impairment or combination of impairments that can be expected to result in death or that has lasted or can be expected to last for a continuous period of at least 12 months.

The Listings describe, for each of the major body systems, examples of impairments we consider severe enough to prevent an adult from doing any gainful activity, or that cause marked and severe functional limitations in a child. The Listings are divided into part A and part B. We apply the medical criteria in part A when we assess the claims of adults. We may also use the criteria in part A when we evaluate SSI childhood disability claims if the disease processes have a similar effect on both adults and children. However, when we evaluate childhood disability claims, we first use the criteria in part B; if those criteria do not apply, we then use the criteria in part A. (See §§ 404.1525 and 416.925).

We last published final rules containing comprehensive revisions to the adult mental disorders listings in the
Federal Register
on August 28, 1985 (50 FR 35038). In the preamble to those rules, we indicated that medical advancements in disability evaluation and treatment and program experience would require that the mental disorders listings be periodically reviewed and updated. We published a Notice of Proposed Rulemaking (NPRM) on July 18, 1991 (56 FR 33130), and invited interested persons, organizations, and groups to submit their comments on the NPRM within 60 days.

We received over 120 letters from individuals and groups commenting on the proposed rules. The commenters generally supported most of the proposed changes, but objected to certain aspects of the proposed rules.

We have carefully considered all of the public comments and are adopting parts of the proposed rules with modifications. Since we published the NPRM, there have been both medical and legislative changes that require us to review some of our proposed revisions again. For example, the American Psychiatric Association's publication of the Fourth Edition of the “Diagnostic and Statistical Manual of Mental Disorders” (DSM-IV) in May 1994 impacts directly on our proposal to incorporate terminology from the DSM Third Edition-Revised (DSM-III-R). The changes made to the childhood disability program by Public Law 104-193, the Personal Responsibility and Work Opportunity Reconciliation Act of 1996, affects our proposal to extend use of the special technique for evaluating mental impairment severity to childhood mental disorders claims evaluated under part B of the Listings.

Consequently, we are deferring action on the proposed revisions that are not finalized by these regulations. We are not incorporating DSM-III-R terminology or establishing a new psychoactive substance dependence listing (listing 12.09) with its own paragraph A diagnostic criteria and paragraph B functional criteria. We are reassessing this latter proposal as a result of the provisions of Public Law 104-121 that prohibit eligibility for disability benefits when drug addiction or alcoholism (DAA) is a contributing factor material to the determination of disability. We are not incorporating the “capsule definition” into the paragraph A diagnostic criteria of each listing, although we have addressed the relevance of the capsule definition in these final rules. We are not providing definitions of the scale points in §§ 404.1520a and 416.920a or expanding application of the special technique we use to evaluate adult mental disorders to the childhood mental disorders listings. Finally, we are not adding criteria to listing 12.07 to address eating and tic disorders.

In these final rules, we are revising the third and fourth paragraph B functional criteria in each listing. We are adding paragraph C functional criteria to listings 12.02 (Organic Mental Disorders) and 12.04 (Affective Disorders). We are standardizing at two the number of paragraph B criteria that an impairment must satisfy to meet a listing. In §§ 404.1520a and 416.920a, we are modifying the B criteria rating scales and the requirements for documenting application of the technique at all review levels. We also are deleting certain provisions that address issues that already are covered in other regulations. We are adding a new paragraph F in the introductory text to the neurological listings that discusses the evaluation of traumatic brain injury. We also are making changes to and reorganizing the introductory text to the mental disorders listings.

We discuss below the significant differences between the proposed rules and final rules. We also respond to the significant public comments on these final rules. We will consider the public comments we received on the proposed revisions that we are not finalizing by

these regulations as we reassess those proposals.

The revised adult mental disorders listings (and other listings) in these rules will be effective until July 2, 2001, unless they are extended by the Commissioner or revised and promulgated again.

Explanation of the Final Rules

Sections 404.1520a and 416.920a Evaluation of Mental Impairments

We revised and clarified our rules in these sections on the procedure we use to evaluate the severity of mental impairments. We made revisions in response to public comments, to clarify the proposed language, and for technical reasons. However, the final rules do not include our proposal to expand application of the technique to include evaluation of mental impairment severity under the childhood mental disorders listings. The final rules also do not provide definitions for the scale points, as we proposed. As in the NPRM, we use the term “technique” throughout these sections to facilitate our discussion of this procedure.

Final §§ 404.1520a(a) and 416.920a(a), “General,” are essentially the same as in the prior rules, except for editorial changes that reflect our decision not to apply the technique to childhood mental disorders claims evaluated under part B of the Listings.

Final §§ 404.1520a(b) and 416.920a(b), “Use of the technique,” provide basic information about the application of the technique. They explain that we must first evaluate the evidence to determine whether an individual has a medically determinable mental impairment(s), demonstrated by pertinent symptoms, signs, and laboratory findings. If we determine that an individual has a medically determinable mental impairment(s), we must specify the symptoms, signs, and laboratory findings substantiating its presence. Then, we will rate the degree of functional limitation resulting from that impairment(s) and record our findings as set out in §§ 404.1520a(c) and (e) and 416.920a(c) and (e).

In the final rules, we simplified proposed §§ 404.1520a(b)(1) and 416.920a(b)(1), which contained a number of sentences addressing different issues. Final §§ 404.1520a(b)(1) and (b)(2) and 416.920a(b)(1) and (b)(2), which describe the basic technique, contain the first four sentences of proposed §§ 404.1520a(b)(1) and 416.920a(b)(1), with minor editorial changes.

We deleted the fifth sentence of proposed §§ 404.1520a(b)(1) and 416.920a(b)(1) because it was redundant of the fourth sentence. We also deleted the seventh sentence, which referred to the evaluation of childhood mental impairments. We incorporated the sixth sentence, which describes how we rate the degree of functional limitation, in final §§ 404.1520a(c) and 416.920a(c).

We incorporated the four sentences in proposed §§ 404.1520a(b)(2), with some revisions, in final §§ 404.1520a(c)(3) and (4) and 416.920a(c)(3) and (4). Final §§ 404.1520a(b)(2) and 416.920a(b)(2) now state that we must rate the degree of limitation in accordance with final §§ 404.1520a(c) and 416.920a(c) and record our findings as set out in final §§ 404.1520a(e) and 416.920a(e).

We deleted proposed §§ 404.1520a(b)(3) and 416.920a(b)(3) in which we had defined the rating scale points for each of the first three functional areas. We also deleted proposed §§ 404.1520a(b)(4) through (7) and 416.920a(b)(4) through (7) in their entirety, since they addressed rating scale points for assessing the degree of limitation for childhood mental impairments evaluated under part B of the Listings.

As we explain in more detail in the public comments section of this preamble, we expanded final §§ 404.1520a(c) and 416.920a(c), “Rating the degree of functional limitation,” to respond to many comments we received about the technique. In final §§ 404.1520a(c)(1) and 416.920a(c)(1), we explain that the assessment of functional limitations is a complex and highly individualized process requiring consideration of multiple issues. We stress that in addition to symptoms, signs, and laboratory findings, we consider other factors, such as the effects of chronic mental disorders, structured settings and the effects of medication and other treatment. We also stress that we must consider the individual's functioning over time.

We provide further detail about these principles in final §§ 404.1520a(c)(2) and 416.920a(c)(2). The first sentence explains that when we rate the degree of functional limitation, we consider the extent to which the individual's impairment or combination of impairments interferes with the ability to function independently, appropriately, effectively, and on a sustained basis. The second sentence explains that we will consider factors including the quality and level of the individual's overall performance, any episodic limitations, the amount of supervision or assistance required, and the settings in which the individual can function. The third sentence provides a cross-reference to 12.00C through 12.00H of the introductory text to the adult mental disorders listings for more information about the factors we consider.

Final §§ 404.1520a(c)(3) and 416.920a(c)(3) are based on the first sentence of proposed §§ 404.1520a(b)(2) and 416.920a(b)(2). They list the four functional areas we consider (activities of daily living; social functioning; concentration, persistence, or pace; and episodes of decompensation) when we employ the technique.

Final §§ 404.1520a(c)(4) and 416.920a(c)(4) explain that we will use a five-point scale (none, mild, moderate, marked, and extreme) when we rate the degree of limitation in the first three functional areas (i.e., all but “episodes of decompensation”). We also include the statement from the last sentence of §§ 404.1520a(b)(3) and 416.920a(b)(3) of the prior rules, which we had included in the NPRM. However, we revised the statement in response to comments. Instead of providing that the last two points of the five-point rating scale represent degrees of limitation that are incompatible with the ability to do a work-related function, the final rules provide that the last point of the scale represents a degree of limitation that is incompatible with the ability to do any gainful activity. We explain our reasons for this change in the public comments section of this preamble.

Final §§ 404.1520a(d) and 416.920a(d), “Use of the technique to evaluate mental impairments,” correspond to prior §§ 404.1520a(c) and 416.920a(c) and proposed §§ 404.1520a(c) and 416.920a(c). In the final rules, we revised the language that related to proposed changes in the rating scale points and deleted proposed §§ 404.1520a(c)(2) and 416.920a(c)(2) in their entirety.

Final §§ 404.1520a(d)(2) and 416.920a(d)(2), which explain how we determine whether an impairment meets or is equivalent in severity to a mental listing, correspond to prior §§ 404.1520a(c)(2) and 416.920a(c)(2) and proposed §§ 404.1520a(c)(3) and 416.920a(c)(3). In response to a comment, the final rules contain the first sentence of prior §§ 404.1520a(c)(2) and 416.920a(c)(2), slightly edited. The sentence explains that we will determine whether an impairment meets or is equivalent in severity to a listing if we first determine that the individual has a severe impairment(s). We also revised the second sentence slightly for context.

Final §§ 404.1520a(d)(3) and 416.920a(d)(3) correspond to prior §§ 404.1520a(c)(3) and 416.920a(c)(3)

and proposed §§ 404.1520a(c)(4) and 416.920a(c)(4). These sections explain that we will make a residual functional capacity (RFC) assessment whenever an individual has a severe impairment or combination of impairments that neither meets nor is equivalent in severity to any listing. In the NPRM, we had replaced the reference to a “residual functional capacity” assessment with a more generic reference to a functional assessment in order to include children. Also in response to a comment, we further revised the sentence proposed in the NPRM and deleted the last phrase (“when appropriate to the category of claim being assessed”). The phrase suggested that in some cases we would not do RFC assessments of individuals who have severe impairments that neither meet nor are equivalent in severity to any listed impairment. In fact, we always do RFC assessments in these circumstances.

Final §§ 404.1520a(e) and 416.920a(e), “Documenting application of the technique,” correspond to prior §§ 404.1520a(d) and 416.920a(d), “Preparation of the document,” and proposed §§ 404.1520a(d) and 416.920a(d). The final rules, like the NPRM, explain that we must complete a standard document showing the application of the technique in each case at the initial and reconsideration levels of the administrative review process. At the hearings and appeals levels, administrative law judges and the Appeals Council must record the application of the technique in their decisions. We revised the heading slightly from the NPRM (from “this technique” to “the technique”) for consistency. We also made editorial revisions in the two sentences that make up the paragraph.

In final §§ 404.1520a(e)(1) and 416.920a(e)(1) (proposed §§ 404.1520a(d)(1) and 416.920a(d)(1)), we clarified the provisions addressing the role of the disability examiner in preparing the standard document. However, we retained the basic provision, which permits the disability examiner to assist the medical or psychological consultant in preparing the form. We describe the revisions and our response to the comments we received on the proposed rules in the public comments section of this preamble. In a technical correction, we revised the opening phrase of the first sentence to make it clearer that the medical or psychological consultant has overall responsibility for assessing medical severity at the reconsideration level except when a disability hearing officer makes the determination. When a reconsideration determination is made by a disability hearing officer, the disability hearing officer has overall responsibility for assessing medical severity.

Final §§ 404.1520a(e)(2) and 416.920a(e)(2) (proposed §§ 404.1520a(d)(2) and 416.920a(d)(2)), which describe what administrative law judges and the Appeals Council must include in their decisions to document the technique, are substantively unchanged from the NPRM. We made minor editorial corrections and revised the cross-references to reflect the organization of the final rules.

We made a number of changes in final §§ 404.1520a(e)(3) and 416.920a(e)(3) (proposed §§ 404.1520a(d)(3) and 416.920a(d)(3)) in response to public comments. We proposed revisions to the procedures under which administrative law judges may return cases to the State agencies. We describe these revisions and our reasons for making them in the public comments section of this preamble. We also made minor, nonsubstantive editorial revisions in the paragraph.

Appendix 1 to Subpart P—Listing of Impairments

11.00F Traumatic Brain Injury (TBI)

As in the proposed rules, the final rules include a new 11.00F in the preface to the adult neurological listings that provides guidance for the evaluation of cases involving traumatic brain injury (TBI). In response to a comment, we changed the heading of the final section from the proposed “Cerebral trauma.”

TBI cases are evaluated under reference listing 11.18, “Cerebral trauma.” Final 11.00F recognizes the sometimes unpredictable course of TBI during the first few months post-injury. Thus, final 11.00F provides three situations for evaluating disability based on alternative possible courses. First, it explains that the neurological impairment may be so profound following the trauma that it will be possible to decide immediately that an individual is disabled. Second, it explains that if there is not such a profound initial neurological impairment, we will defer adjudication of the claim until we obtain evidence of any neurological and mental impairments at least 3 months post-injury. Third, if a finding of disability is still not possible at 3 months post-injury, we will again defer adjudication of the claim until we obtain evidence at least 6 months post-injury.

We made a number of editorial clarifications in final 11.00F, partly in response to comments and partly for clarity and precision of the final language. None of the changes are substantive. For instance, we deleted the word “listing” in all but one place to be consistent with the style of other paragraphs of the listings. We also replaced such phrases as “make a final adjudication” and “favorable decision,” which have other connotations in our program, with more accurate phrases, such as “adjudicate the claim” and “finding of disability.” Among other changes, we also revised 11.00F to make it clear that an individual with TBI may have a neurological or a mental impairment, or both.

The most extensive editorial revision is to the second paragraph of proposed 11.00F, which consisted of ten sentences that addressed more than one subject. In final 11.00F, we divided the proposed second paragraph into two paragraphs (the second and third paragraphs of final 11.00F). We also reorganized the sentences of the proposed paragraph so that each paragraph addresses one subject. Thus, the second paragraph of final 11.00F includes the first, second, third, fifth, sixth, and seventh sentences of the NPRM, which describe the variable course of TBI. The third paragraph includes the fourth, eighth, ninth, and tenth sentences, which explain when we will proceed with adjudication and when we will defer adjudication.

12.00 Mental Disorders

The final listings do not include all of the substantive revisions we had proposed. The proposed revisions reflected evolving medical knowledge of the characteristics of mental disorders and their treatment and management. They also reflected the program experience we have gained in monitoring and evaluating the prior listings.

For example, in the proposed revisions, we had updated the medical terms used to describe the major mental disorders and their characteristics and symptoms to conform to the nomenclature in the DSM-III-R published by the American Psychiatric Association. The DSM is widely used by psychiatrists, psychologists, and other mental health professionals. It provides a common basis for communication and facilitates our evaluation of medical reports when we make determinations of disability.

The American Psychiatric Association has an ongoing process to update the DSM. The fourth edition of the DSM (DSM-IV) was published in May 1994. We decided to publish these final rules without the changes we had proposed, rather than further delay them to

incorporate any additional changes in the terminology and diagnostic criteria from the DSM-III-R to the DSM-IV. In the meantime, we are reviewing those changes in the DSM-IV that pertain to our listings to determine whether we need to revise these final listings at a future date.

We retained one substantive change from the proposed listings; the final rules make the requirement for limitations in two of the areas under paragraph B the uniform standard for all listings that employ paragraph B functional criteria.

One nonsubstantive change we made from the proposed listings was to separate mental retardation and autistic disorder and other pervasive developmental disorders into two listings, listings 12.05 and 12.10, respectively. We discuss this change in detail in the summary below and in the public comments section of this preamble.

The following is a detailed description of the changes in each section.

12.00 Preface

12.00A Introduction

Final 12.00A, “Introduction,” describes the structure of the listings and explains how we apply them. This section also provides guidance about the severity of the listings, how we determine equivalence, and how we determine residual functional capacity (RFC). In the final rules, we updated the list of titles of the listing categories to reflect the change in 12.05 and the addition of 12.10. We also updated the list of listings with paragraph C criteria. In addition, we expanded the discussion regarding the application of the paragraph B and C criteria. We now specify that the evaluation of functional limitations must be done by applying the paragraph B criteria first. We will apply the paragraph C criteria only if we find that the paragraph B criteria are not satisfied. Because final listing 12.09, “Substance addiction disorders,” remains a reference listing, we restored the description of the listing found in the prior rules. We also added a description of the structure of listing 12.05, “Mental retardation,” because it is the only other listing that does not employ the same paragraph A-paragraph B system as the other mental disorders listings in all of its sections. However, we clarified the proposed description in the final rules in response to public comments about the listing itself. The description in the final rules also reflects the fact that we removed “autistic disorder and other pervasive developmental disorders” from listing 12.05 and placed them in a separate listing 12.10. We did this both in response to a public comment and for consistency with the childhood mental disorders listings. We discuss this change in greater detail in the public comments section of this preamble.

We also explain in final 12.00A that the listings contain examples of disorders that are considered severe enough to preclude an individual from doing any gainful activity. If an impairment does not meet the requirements of a listing, we will determine whether the individual's impairment(s) is equivalent in severity to a listed impairment. We revised the discussion regarding determinations of equivalence in the sixth paragraph of final 12.00A because some of the comments about proposed listing 12.09 indicated that there could be confusion about how we evaluate a medically determinable severe mental impairment that does not satisfy all of the paragraph A criteria of a particular listing. The last sentence now states that in such cases, the assessment of the paragraph B and C criteria is critical to a determination of equivalence.

12.00B Need for Medical Evidence

Final 12.00B, as in the prior rules, repeats basic principles of disability evaluation that are set out in the regulations, but focuses specifically on the evaluation of mental disorders. It describes the need to establish the existence of a medically determinable impairment of the required duration, and defines the terms “symptoms” and “psychiatric signs.” It also explains that symptoms and signs generally cluster together to constitute the recognizable mental disorders described in the listings. This section also provides a reminder that symptoms and signs may be intermittent or continuous.

In response to a comment, we revised the third sentence of proposed 12.00B to indicate that the specific psychological abnormalities named in the sentence are only examples of such abnormalities. The sentence does not contain an all-inclusive list. We also revised the examples of abnormalities in response to a comment and updated the terminology. We also deleted the example of psychiatrists and psychologists as appropriate medical sources. We describe all of these changes in the public comments section of this preamble.

12.00C Assessment of Severity

This section explains how we assess severity under the listings using the paragraph B and C functional criteria. It briefly defines the term “marked” and describes each of the four functional areas in detail. Throughout final 12.00C, as in the NPRM, we incorporated references to the ability to sustain function. This reflects more clearly our longstanding policy that the ability to sustain function is essential to the effective performance of the function.

The opening paragraph of final 12.00C is substantively the same as in the prior rules. As in the NPRM, we simplified and clarified it without any change in meaning. In response to a comment, we replaced the descriptive “ability to tolerate increased mental demands associated with competitive work or other stressful circumstances,” with the more accurate and simpler heading of the fourth functional criterion, “episodes of decompensation,” in the list of the four functional areas. We explain our reasons for this revision in the public comments section of this preamble under the comments about 12.00C4. We also moved the cross-reference to §§ 404.1520a and 416.920a to the end of the paragraph.

Final 12.00C1 describes the first paragraph B criterion, activities of daily living. The final paragraph is different from the prior rules in only one respect. The example at the end of the second paragraph of the section in the prior rules was too narrow; therefore, we had revised the example in the NPRM. In response to a comment about that revised example, however, we replaced it with a more comprehensive and descriptive example.

Final 12.00C2 describes the second paragraph B criterion, social functioning. Except for editorial changes, the final paragraph is the same as the prior rules and the NPRM.

Final 12.00C3 describes the third paragraph B criterion, concentration, persistence, or pace. The title of the final paragraph does not reflect the change we had proposed in the NPRM, “Task completion.” However, we made it consistent with §§ 404.1520a, 416.920a, and the listings themselves by changing the “and” to “or.” The final paragraphs incorporate most of the proposed revisions. We also clarified how we assess concentration, persistence, or pace in work evaluations.

The prior paragraph 12.00C3 consisted of eight sentences. We simplified final 12.00C3 by dividing the sentences into separate paragraphs. In addition, we made a number of revisions in the final rules in response to public comments. Besides revising the proposed text in response to the comments, we also added two paragraphs to the final rules. The

revisions remove the example of “everyday household routines” in the first paragraph of proposed 12.00C3, and explain that an individual's ability to function in settings other than work settings is important. They also provide more information about how we evaluate such activities. The revisions provide guidance about the need to consider all relevant evidence, and such factors as whether the individual is functioning in a structured setting. In addition, we clarified that we meant our reference in the first paragraph of proposed 12.00C3 to “direct psychiatric examination” to include clinical examinations performed by psychologists. We also restored the three examples of work tasks from the prior rules, and we added a reference to “serial threes” as a test of concentration. We describe all of these changes in detail, and our reasons for making them, in the public comments section of this preamble.

Final 12.00C4 describes the fourth paragraph B criterion, and the first paragraph C criterion, episodes of decompensation. As in the NPRM, we deleted the reference to “work or work-like settings” because episodes occurring outside these settings can be equally useful in assessing an individual's ability to work and because, as a practical matter, the information in cases does not often come from observations in work or work-like settings.

We substantially revised final 12.00C4 in response to many public comments we received about the section itself and about the paragraph B and C criteria in the proposed listings. Final 12.00C4 now contains two paragraphs. The first paragraph defines “episodes of decompensation,” without the proposed phrase, “causing deterioration.” We also revised the proposed definition to make clear that episodes of decompensation are accompanied by a loss of adaptive functioning, instead of stating that such episodes “may include” loss of adaptive functioning, as we had proposed. A new second sentence in the first paragraph explains that episodes of decompensation may be demonstrated by an exacerbation in symptoms or signs that would ordinarily require increased treatment, or a less stressful situation (which can include withdrawal from the stressful situation), or a combination of the two. Such an episode may be shown by significant alteration in medications, documentation of the need for a more structured psychological support system, or other relevant information.

We also added a new second paragraph in final 12.00C4. The first sentence introduces and defines the term, “repeated episodes of decompensation, each of extended duration.” In the final rules, we used this term in each of the paragraph B4 and C1 listing criteria instead of repeating the requirement, as we had proposed in the NPRM, that the episodes of decompensation average three times within 1 year or once every 4 months, and each last for at least 2 weeks. We provide guidance in the second sentence of this new paragraph for evaluating episodes of decompensation that occur less frequently than three times in a year or once every 4 months but last longer than 2 weeks, or that are of shorter duration but occur more frequently.

We made all of the changes in final 12.00C4 in response to comments. We describe the comments and give our reasons for making these changes in the public comments section of this preamble under the heading for 12.00C4 and under the heading for listing 12.02, where we discuss all of the general comments about the paragraph B4 and C1 criteria in the listings.

12.00D Documentation

As in the NPRM, we greatly expanded final 12.00D from the prior rules to provide guidance about several aspects of the documentation of claims involving mental disorders. We made many changes in the final rules in response to comments, most of which we describe in the public comments section of this preamble.

In response to the comments, we reorganized and simplified the final section. Proposed 12.00D contained 24 paragraphs, none of which had headings, or number or letter designations. As a result, the proposed section was somewhat cumbersome and some of the comments indicated to us that it needed an internal structure.

Proposed 12.00D addressed a number of different topics that all fall under the heading, “Documentation,” but are otherwise separate topics. The first four and one-half paragraphs of the proposed section discussed general issues associated with the development of claims: Requirements to obtain medical evidence to establish the existence of a medically determinable impairment; the value of information from the individual and others who know the individual; the need to establish a longitudinal record because of variations in functioning; the relevance of work; and the purchase of consultative examinations employing psychometric testing. From the middle of the proposed fifth paragraph through the proposed eighteenth paragraph, we provided technical discussions about psychological testing, including two paragraphs devoted to neuropsychological testing. The nineteenth through twenty-fourth paragraphs primarily discussed issues related to the documentation of particular disorders.

Aside from the fact that reference to the numerous unnumbered paragraphs in the section was difficult, our proposal grouped together different topics without any indication that they addressed more-or-less distinct subjects. This unstructured organization confused some commenters about our intent in several areas. Therefore, in response to the comments, we provided headings and number or letter designations for each of the paragraphs wherever we believed that they would help clarify the rules. The final rules are structured as follows.

The opening paragraph of final 12.00D is based on the first paragraph of prior 12.00D and the first paragraph of proposed 12.00D and includes new provisions that we added in response to a comment. The paragraph provides general guidance that the documentation in a claim must include sufficient evidence to establish the existence of a medically determinable mental impairment(s), to assess the degree of functional limitation the impairment(s) imposes, and to project the probable duration of the impairment(s). It also provides a cross-reference to §§ 404.1512 and 416.912, which define the term “evidence” and describe the various individuals, institutions, and agencies that can provide evidence. These regulatory sections also explain the efforts we will make to assist individuals in obtaining existing evidence or in developing evidence (such as through a consultative examination) for their claims.

The remainder of the opening paragraph of final 12.00D provides three reminders of longstanding policies in our regulations that we apply to all individuals, not just those with mental impairments. First, the medical evidence must be sufficiently complete and detailed to permit an independent determination. Second, we should consider information from other relevant sources (including nonmedical sources) in determining how an individual's medically determinable impairment(s) affects his or her ability to function. Third, we will consider all relevant evidence in the case record.

Final 12.00D1, “Sources of evidence,” is divided into three parts. Final 12.00D1a, “Medical evidence,” explains that we must have evidence from an acceptable medical source showing that an individual has a medically

determinable mental impairment. It further provides that we will make every reasonable effort to obtain all relevant and available medical evidence about an individual's mental impairment. It also explains that, whenever possible, and appropriate, medical source evidence should reflect the source's consideration of information from the individual and other concerned persons who are aware of the individual's functioning. In accordance with standard clinical practice, any medical source assessment of an individual's mental functioning should take into account sensory, motor, or communication abnormalities and the individual's cultural and ethnic background. These provisions are based on the third sentence of the first paragraph and part of the last sentence of the third paragraph of proposed 12.00D, but are significantly expanded and revised.

Final 12.00D1b, “Information from the individual,” corresponds to the first two sentences of the second paragraph of proposed 12.00D, which we revised in response to comments. It now explains that individuals with mental impairments can often provide accurate descriptions of their limitations, but recognizes that some individuals may not be willing or able to fully describe their limitations. Therefore, we must carefully examine statements from each individual to determine if they are consistent with the other evidence of record and to determine whether we need additional information about the individual's functioning from the individual or from other sources.

Final 12.00D1c, “Other information,” corresponds to the third and fourth sentences of the second paragraph and the last sentence of the third paragraph of proposed 12.00D. It explains how we consider information from other health care providers, records from work evaluations and rehabilitation progress notes, and lay sources, such as family members.

Final 12.00D2, “Need for longitudinal evidence,” corresponds to most of the third paragraph of proposed 12.00D. We explain that an individual's level of functioning may vary considerably over time, so that functioning at a specific time—regardless of whether it is adequate or poor—may not be an accurate indicator of the overall severity of the individual's impairment(s). This section explains that proper evaluation of the impairment(s) must take into account any variations in the level of functioning. It also explains that it is vital to obtain evidence from relevant sources over a sufficiently long period to establish impairment severity. Apart from minor editorial revisions, the final paragraph is unchanged from the NPRM.

Final 12.00D3, “Work attempts,” corresponds to the fourth paragraph of proposed 12.00D. In response to a comment, we added a sentence reminding adjudicators to consider the degree to which an individual requires special supports, such as those provided through supported employment or transitional employment programs, in order to work. Otherwise, the substance of the final paragraph is unchanged from the NPRM.

Final 12.00D4, “Mental status examination,” is a new paragraph that we added in response to a comment. It describes the components of mental status examinations and the circumstances under which such examinations are performed.

Final 12.00D5, “Psychological testing,” consists of three paragraphs. Final 12.00D5a corresponds to the third sentence of the fifth paragraph of proposed 12.00D. It explains the reference to “a standardized psychological test” in these listings and what we mean by the term “qualified” specialist. We also divided the proposed sentence into two sentences and clarified our intent.

Final 12.00D5b provides guidance about the general kinds of information one can expect to elicit from psychological tests. It begins with a sentence that is based on the last sentence of the fifth paragraph of proposed 12.00D, which we revised in response to a comment. We now state that psychological tests elicit a range of “responses,” rather than “behaviors.” The paragraph finishes with the provisions from the first two sentences of the ninth paragraph of proposed 12.00D. These sentences explain that other information can be obtained from psychological testing, such as information from the specialist's observations about the individual's ability to do the test.

Final 12.00D5c is the same as the sixth paragraph of proposed 12.00D except for minor editorial changes. It provides technical information about the salient characteristics of a good test. The section also reminds adjudicators about the need to note and resolve any discrepancies between formal test results and the individual's customary behavior and daily activities.

Final 12.00D6, “Intelligence tests,” consists of five paragraphs, designated 12.00D6a through 12.00D6e. These paragraphs incorporate various provisions from the fifth, eighth through eleventh, fifteenth, and sixteenth paragraphs of the proposed rules. These provisions of the proposed rules specifically concerned intelligence testing and properly should have been grouped together. In the course of reorganizing the provisions, we also revised them to simplify and clarify the rules.

We made several substantive changes throughout 12.00D6 in response to comments. We address the substantive changes in the public comments section of this preamble.

In 12.00D6d we made some technical changes. First, we added an introductory sentence which indicates that it is usually preferable to use IQ measures that are wide in scope and test both verbal and performance abilities. Then, we deleted the word “nonverbal,” which had been in the eighth paragraph of the proposed rules, and also deleted the reference to “the Raven Progressive Matrices” and added a reference to the “Test of Nonverbal Intelligence, Third Edition (TONI-3).”

In addition, in final 12.00D6e, we made technical changes from the proposed rules. The final paragraph combines provisions from the fifteenth and sixteenth paragraphs of proposed 12.00D. These paragraphs discussed exceptions to formal standardized psychological testing and contained language that we copied from the fifteenth and sixteenth paragraphs of 112.00D in the childhood mental listings. In reviewing the sixteenth paragraph, we noted technical inaccuracies that had to be corrected. In the proposed rules, we referred to the “Scale of Multi-Cultural Pluralistic Assessment (SOMPA),” and called it a “culture-free” test. A more appropriate term is “culture-fair.” The SOMPA, however, is a test for children age 5 to 11 years 11 months old; therefore, reference to it is not appropriate in the adult rules. Moreover, the SOMPA battery of tests includes an age-appropriate Wechsler scale of intelligence. Since the Wechsler scales are English-language tests, they are not culture-fair. As such, their inclusion as part of the SOMPA makes that battery of tests not culture-fair, and therefore inappropriate for inclusion in the sixteenth paragraph of 112.00D of the childhood rules.

Also, the proposed sixteenth paragraph did not convey our intended meaning. The provision that required testing in an individual's principal language would have inadvertently ruled out consideration of the results of testing not done in the individual's principal language that happened to be part of the existing medical evidence. It also would have ruled out the possibility of testing a bilingual

individual in English, even if the individual has sufficient fluency in English as a second language. Further, the paragraph allowed for testing through a translator in some circumstances, even though this would introduce a variable that might compromise the results of the test. This was not our intent.

For all these reasons, we deleted the second through sixth sentences of the proposed sixteenth paragraph. Because the remaining paragraph was so similar to the proposed fifteenth paragraph, we combined the fifteenth and sixteenth paragraphs under one heading in final 12.00D6e. The paragraph addresses exceptions to formal standardized testing, including exceptions to standardized testing in the individual's own language. We still retain reference to the Leiter International Performance Scale-Revised and a discussion of individuals whose culture and background are not principally English-speaking in final 12.00D6d; therefore, there is no need to repeat the reference and discussion in final 12.00D6e.

Also, the fifteenth and sixteenth paragraphs of 112.00D of the childhood listings included some of the same wording that was problematic in the proposed adult rules. For this reason, and to maintain consistency between part A and part B, we replaced the fifteenth and sixteenth paragraphs in 112.00D with the same wording found in final 12.00D6d and 12.00D6e, revised slightly to make reference to children.

In final 12.00D7, “Personality measures and projective testing techniques,” we combined and simplified the provisions in the twelfth and fourteenth paragraphs of the proposed rules. The paragraph addresses standardized personality measures (such as the Minnesota Multiphasic Personality Inventory-Revised, or MMPI-II) and projective types of techniques (such as the Rorschach and Thematic Apperception Test, or TAT). For reasons we explain in the public comments section of this preamble, we deleted the proposed discussion devaluing these two types of tests. This deletion includes the discussion of the “limited applicability” of personality measures, and the statement that projective tests are not useful for program purposes. We now state that these tests may provide useful data for evaluating several types of mental disorders. In addition, we acknowledge that such test results may be useful for disability evaluation when corroborated by other evidence.

Final 12.00D8, “Neuropsychological assessments,” incorporates paragraphs seventeen through twenty of proposed 12.00D. We deleted the last two sentences of the proposed eighteenth paragraph of the NPRM in response to comments. In the last sentence of the first paragraph, which corresponds to the last sentence of the seventeenth paragraph of proposed 12.00D, we changed the word “professionals” to “specialist,” consistent with the terminology in final 12.00D5. We also deleted the phrase, “and applying its findings in the disability decisionmaking process,” because we have other regulations that address the qualifications of our medical and psychological consultants. We also reorganized and simplified the remaining provisions somewhat, but did not make substantive changes.

Final 12.00D9, “Screening tests,” corresponds to the thirteenth paragraph of proposed 12.00D. For reasons we explain in the public comments section of this preamble, we deleted the second and third sentences of the proposed paragraph. We also simplified the remaining language without making any substantive changes.

Final 12.00D10, 12.00D11, and 12.00D12 address three specific types of impairments. Final 12.00D10, “Traumatic brain injury (TBI),” corresponds to the twenty-second paragraph of proposed 12.00D. We expanded the statement we proposed, which referred only to the “evaluation” guidelines in 11.00F, to refer to the “documentation and evaluation” guidelines in 11.00F. We also made minor editorial changes, including a different heading for this paragraph. We describe our reason for making this change above, under the heading for 11.00F.

Final 12.00D11, “Anxiety disorders,” corresponds to the twenty-third paragraph of proposed 12.00D. The final and proposed paragraphs are nearly identical. We changed “testimony” to “statements” in the last sentence of the final paragraph.

Final 12.00D12, “Eating disorders,” corresponds to the twenty-fourth paragraph of proposed 12.00D. We made a technical clarification in the last sentence of the final paragraph. The sentence in the NPRM indicated that when the primary functional limitation is physical, any mental manifestations “must” also be considered in addition to the physical manifestations of the impairment. In the final paragraph, we added a clause to the end of the sentence providing an exception for the situation in which a fully favorable determination or decision is possible based on the physical findings alone. In such a case, we would not need to consider the individual's mental manifestations because we will have already found him or her disabled. Otherwise, there is no substantive change from the NPRM in the final paragraph.

Finally, we deleted four of the proposed paragraphs. We deleted the nineteenth and twentieth paragraphs because they addressed the evaluation of declines in cognition from premorbid functioning, a reference to the paragraph A7 criterion in listing 12.02. We are deferring adding these two paragraphs until we reassess the proposed changes to the A criteria of the listings. We deleted the seventh paragraph in response to a comment that pointed out that the paragraph could have been misinterpreted to preclude consideration of testing that did not demonstrate all of the salient characteristics of a “good test.” We deleted the twenty-first paragraph (which was also the ninth paragraph of prior 12.00D) because it could have been misleading in the context of the new rules. The paragraph explained that when the individual's cognitive impairment is such that standard intelligence testing is precluded, medical reports and observations by other individuals should be obtained to describe the individual's functioning. In fact, we may need this kind of evidence regardless of the type of impairment involved or whether intelligence testing is precluded. We did not want to give the impression that this was the only circumstance in which we would gather such evidence, and we have other rules that describe the various sources of evidence.

12.00E Chronic Mental Impairments

This section provides guidance and reminders for the evaluation of chronic mental disorders. Although the substance of the final rules is unchanged from the prior rules, we made minor editorial changes for clarity and comprehensiveness. We did not receive any comments about this section.

12.00F Effects of Structured Settings

Final 12.00F explains some of the factors we consider when an individual has overt symptomatology that is controlled or attenuated by psychosocial factors. We received two favorable comments and one suggestion about this provision, which we address in the public comments section of this preamble. The final rule is unchanged from the NPRM, except for minor editorial changes.

12.00G Effects of Medication

This section provides guidance about how we assess the effects of medication when we determine the functional limitations caused by an individual's mental impairment(s). In the final rules, we changed the terminology to reflect generic names for describing medications used in the treatment of mental disorders. As a result, we substituted the more common term “drugs” for “psychoactive medications” in the second and third sentences of the first paragraph and the first sentence of the second paragraph. Although the prior rules had used “neuroleptics” in the second paragraph, this specific class of drugs is subsumed under the broad term, “drugs.”

12.00H Effects of Treatment

This section provides a reminder that treatment may have positive effects to the extent that an individual may not be disabled. Therefore, the paragraph includes a reminder that treatment “may or may not” enable an individual to work.

The final paragraph is substantively unchanged from the prior rules. In the NPRM, we proposed simplifying the paragraph and revising the parenthetical reference to include 12.02 and 12.04, which now also contain paragraph C criteria. In response to a comment about the fourth paragraph of proposed 12.00D, we also clarified the second sentence of the section to indicate that treatment may or may not assist in the achievement of an adequate level of adaptation required for “sustained SGA” instead of in the “workplace.” This is not a substantive change, only a clarification; we explain it more fully in the public comments section. We pluralized the word “effect” in the heading in the final rules for accuracy and consistency with the headings of the previous sections.

12.00I Technique for Reviewing Evidence in Mental Disorders Claims To Determine the Level of Impairment Severity

This brief section provides a cross-reference to §§ 404.1520a and 416.920a, which describe the technique that must be followed in claims involving mental impairments. Except for minor editorial simplification, the section is the same as in the NPRM, with minor editorial changes. We did not receive any comments about this section.

12.01 Category of Impairments, Mental

12.02 Organic Mental Disorders

In final listing 12.02, there are no changes in the paragraph A criteria from the prior rules, because we deferred making any of the changes we had proposed in the NPRM.

In the paragraph B criteria of listing 12.02, and all other listings that employ paragraph B criteria, we changed the paragraph B3 criterion (marked difficulties in maintaining concentration, persistence, or pace) to parallel the paragraph B1 and B2 criteria. In response to a comment that pointed to possible future misunderstandings, we simplified the criterion, for reasons we explain in the comments and responses section of this preamble. For consistency, we made similar changes in a number of places in 112.00.

We reworded final paragraph B4 to focus on decompensation. (The use of the word “decomposition” throughout the NPRM was a typographical error, although we did receive several comments about it.) As we explain under the heading for 12.00C, we defined the paragraph B4 criterion in the preface at 12.00C4. The paragraph B4 criterion now states, “Repeated episodes of decompensation, each of extended duration.”

We added a new paragraph C to listing 12.02 to evaluate individuals with chronic organic mental disorders with symptoms or signs that are currently attenuated by medication or psychosocial support. These new provisions are similar to paragraph C of listing 12.03. The introductory paragraph of listing 12.02C reflects our longstanding policy as to what constitutes a “severe” impairment under §§ 404.1521, 416.921, 416.924, and Social Security Ruling 85-28. It also explains that a “chronic” mental disorder is one that has lasted for at least 2 years.

The opening sentence of paragraph C is substantively the same as in the NPRM, except for two minor editorial revisions. We revised paragraph C1, which in the proposed rules was identical to the paragraph B4 criterion, to reflect the changes in final paragraph B4. In response to a comment, we added a new paragraph C2 to address individuals who have a residual disease process and who do not suffer repeated episodes of decompensation, but who are so marginally adjusted that even a minimal increase in mental demands or a change in environment would be predicted to cause decompensation. As we explain in the public comments section, this is a longstanding policy interpretation that we intended paragraph C to cover.

Final paragraph C3, which was paragraph C2 in the NPRM, is unchanged, except for minor editorial changes. We based this revision on the prior listing 12.03C2 criterion describing a documented inability to function outside of a highly supportive living arrangement. We did not change the requirement from the proposed rules for a documented current history of an inability to function 1 or more years, in keeping with the statutory definition of disability, which requires that a disability must last for at least 12 months. The prior rules required a 2 year history.

All of the changes in final listing 12.02 were made in response to public comments. We provide detailed information about these changes, and our reasons for making them, in the public comments section of the preamble.

12.03 Schizophrenic, Paranoid and Other Psychotic Disorders

In the final rules, we revised the opening statement of final paragraph C to better reflect the nature of the disorders covered under listing 12.03. Final paragraphs C1, C2, and C3 are similar to those found in listing 12.02.

We received only one public comment about the proposed listing. Because it was a favorable comment and did not ask us to revise the proposed listing, we do not summarize it below.

12.04 Affective Disorders

Final listing 12.04 incorporates a new paragraph C, similar to the paragraph C criteria in listings 12.02 and 12.03. We revised the proposed paragraph B and C criteria consistent with the revisions to the paragraph B and C criteria we describe for listing 12.02.

We received only two comments about the proposed listing. One was complimentary and one offered a suggested addition to the paragraph A criteria of the listing.

12.05 Mental Retardation

In the final rules, we revised the heading of this listing to limit its scope to mental retardation.

In response to one comment, we expanded the phrase setting out the age limit for the “developmental period.” The final rules clarify that we do not necessarily require evidence from the developmental period to establish that the impairment began before the end of the developmental period. The final rules permit us to use judgment, based on current evidence, to infer when the impairment began. This is not a change in interpretation from the prior rules. We discuss this change in greater detail in the public comments section of this preamble.

In final listing 12.05C, as in the NPRM, we used the word “an” before the word “additional” to clarify that the additional impairment must be “severe” in order to establish “an additional and significant work-related limitation of function.”

In the NPRM, we had removed the second clause of prior listing 12.05D, which referred to autism, and established a new listing 12.05E to evaluate autistic disorder and other pervasive developmental disorders. In response to a public comment and for consistency with the childhood mental disorders listings, we deleted proposed listing 12.05E from the final rules and established a new listing 12.10, “Autistic disorder and other pervasive developmental disorders.” Final listings 12.05 and 12.10 parallel the childhood mental disorders listings 112.05 and 112.10. We made this change to clarify the intent of proposed listing 12.05; the change does not disadvantage anyone. Those individuals diagnosed with both mental retardation and autistic disorder (or other pervasive developmental disorders) can be evaluated under either listing.

We also revised the paragraph B3 and B4 criteria in listing 12.05D to be consistent with the changes in listing 12.02. We summarize all of the comments, explain our responses, and describe the revised language in greater detail in the public comments section of this preamble.

12.06 Anxiety Related Disorders

In final listing 12.06, we made minor editorial changes and revisions to the paragraph B criteria, which we describe under the heading for listing 12.02.

12.07 Somatoform Disorders

In final listing 12.07, we deferred adding eating disorders and tic disorders as we had proposed in the NPRM.

As in the NPRM, the final listing requires that an impairment satisfy only two of the paragraph B criteria instead of three, as in the prior rules. However, we revised the paragraph B criteria in this listing, as we explain under the heading for listing 12.02.

12.08 Personality Disorders

In the final listing, we reduced to two the number of paragraph B criteria needed to meet the listing. There are no substantive differences between the final paragraph B criteria and the NPRM, other than the changes we explain under the heading for listing 12.02.

We did not receive any comments about listing 12.08 requiring a response. We received only favorable comments about our proposal to reduce the required number of paragraph B criteria from three to two.

12.10 Autistic Disorder and Other Pervasive Developmental Disorders

We established this new listing in response to a public comment about proposed listing 12.05. Final listing 12.10 parallels listing 112.10 under the childhood mental disorders listings.

Final listing 12.10 is met when the requirements in paragraphs A and B of the listing are satisfied. The paragraph B criteria, which we discuss under the heading for listing 12.02, are the same as those found in the other adult mental disorders listings.

112.00 Childhood Mental Disorders Listings

We made a number of changes throughout 112.00 to make the childhood mental disorders listings consistent with the final adult listings. In many cases, the revisions are not substantive. In others, our reasons for the changes are the same as our reasons for changing the adult rules, and we explain them above and in the public comments section of this preamble.

As we explain under the summary of final 12.00D6, we also revised the fifteenth and sixteenth paragraphs of 112.00D so that they are the same as final 12.00D6d and 12.00D6e, appropriately revised to refer to children. In addition, we revised the seventeenth paragraph of 112.00D; it is the same as 12.00D8.

Other Changes

In the NPRM, we had proposed to delete the last sentence in paragraph B of 5.00 (Digestive system) in connection with a change we had proposed to listing 12.07, “Somatoform disorders.” We did not receive any comments about this proposal, and, although we did not make the proposed change to listing 12.07, we deleted the sentence in these final rules.

In response to a comment about the definition of psychiatric signs in the third sentence of proposed 12.00B, we broadened and updated the sentence. Because the sentence in 12.00B was based on §§ 404.1528(b) and 416.928(b), we also revised those sections of the regulations and the corresponding sentence in 112.00B. The revisions are not substantive. We describe them in detail under the public comments about proposed 12.00B.

We revised the seventh paragraph of 112.00A to reflect the addition of paragraph C criteria to listings 12.02 and 12.04. We did not otherwise change the substance of the paragraph, however, because we still believe it is not necessary to include paragraph C criteria in the childhood listings.

We made a technical revision to the second sentence of the eighth paragraph of 112.00A to make it consistent with the revisions we made to the fourth paragraph of 12.00A.

In addition, we inserted a new third paragraph in 112.00C which explains that, even though the functional criteria for assessing limitations in children under age 3 are expressed in terms of chronological age, we will follow the rules in § 416.924a(b) when we evaluate the claims of infants and toddlers who are born prematurely. This technical change makes the discussion of how we assess impairment severity in claims involving mental disorders consistent with our other childhood disability rules.

We revised the second, fourth, and fifth sentences of the ninth paragraph of 112.00D so they are consistent with the changes we made in final 12.00D6c. We discuss all of these changes in the public comments section under 12.00D.

Finally, in addition to changes made in response to the comments and the technical changes described above, we made a number of nonsubstantive editorial changes throughout the final adult rules. For example, we changed some of the provisions from the passive voice to the active voice and revised punctuation and capitalization for consistency with our other rules. These revisions are only for clarity and consistency and do not change the meaning of the language we proposed.

Public Comments

After we published the NPRM in the
Federal Register
(56 FR 33130) on July 18, 1991, we mailed copies to national medical organizations and professionals whose responsibilities and interest require them to have some expertise in the evaluation of mental impairments. We also sent copies to Federal and State agencies (including the State agencies that make disability determinations for us) interested in the administration of the title II and title XVI disability programs. As part of our outreach efforts, we invited comments from mental health advocacy groups, as well as from legal service organizations.

We received over 120 letters containing comments pertaining to the changes we proposed. The majority of the comments were from psychologists, organizations and groups that represent people interested in specific mental impairments, and sources with specialized backgrounds in psychiatry. Many of the comments concerned the

specific diagnostic and severity rating criteria for the proposed listings, as well as our proposals to revise the discussion of psychological testing in the preface to these listings.

We carefully considered all of the comments and adopted many of the recommendations relevant to the proposed revisions finalized by these rules. We provide our reasons for adopting or not adopting the recommendations in the summary of the comments and our responses below. A few of the comments, however, pertained to Social Security matters that were not within the scope of the proposed regulations. We referred these comments to the appropriate components of the Social Security Administration and do not address them in this preamble.

Finally, a number of the comments were quite long and detailed. Of necessity, we have had to condense, summarize, or paraphrase them. Nevertheless, we have tried to present all views adequately and to respond to all of the relevant issues raised by the commenters.

Sections 404.1520a and 416.920a Evaluation of Mental Impairments

Comment:
Many commenters expressed concern about the definitions for the terms for rating the degree of functional limitation (e.g., “moderate,” “marked”) in proposed §§ 404.1520a(b)(3) and (b)(7) and 416.920a(b)(3) and (b)(7), which applied to adults and to children from age 3 to attainment of age 18. One commenter asserted that in attempting to clarify the rating scale points, we had focused on a specific range of mental illnesses and lost sight of the need to evaluate mental impairments on a longitudinal basis. As a result, the commenter believed that the proposed definitions only contemplated illnesses that remained constant and failed to consider episodic illnesses.

Several commenters, referring specifically to the proposed definitions of “marked” limitations, were concerned that the proposed rules did not recognize an important principle set out in the opening paragraph of 12.00C. That paragraph explains that a “marked” limitation may arise when several activities or functions are impaired, or even when only one is impaired, as long as the degree of limitation is such as to interfere seriously with the ability to function independently, appropriately, effectively, and on a sustained basis.

Response:
We adopted the comments insofar as they relate to the revisions included in these final rules. As noted in the explanation of the final rules above, we substantially revised proposed §§ 404.1520a and 416.920a.

One substantive change we made in response to the comments was to delete the proposed scale point definitions and examples from the final rules. Instead, we included new language in final §§ 404.1520a(c)(1) and 416.920a(c)(1), expanded final §§ 404.1520a(c)(2) and 416.920a(c)(2), and modified the discussion in §§ 404.1520a(c)(4) and 416.920a(c)(4) regarding the last two scale points, “marked” and “extreme.” We discuss this latter change, and our reasons for it, later in this response.

We recognize that we consider many factors when we assess an individual's functioning. In final §§ 404.1520a(c)(1) and 416.920a(c)(1), we expanded the general guidance we had proposed in §§ 404.1520a(b)(1) and 416.920a(b)(1). The final rules clarify that we will consider the overall functional effects of an individual's impairment(s) longitudinally; i.e., over time. We also explain in the opening sentence of final §§ 404.1520a(c)(1) and 416.920a(c)(1) that the assessment of functional limitations is a complex and highly individualized process that requires us to consider multiple issues and all relevant evidence. In the second sentence, we provide examples of some of the factors that may affect an individual's functioning.

We reinforce these principles in final §§ 404.1520a(c)(2) and 416.920a(c)(2). Our intent in these paragraphs is to explain that the basic consideration in assessing functional limitations is the extent to which an individual's impairment or combination of impairments interferes with his or her ability to function independently, appropriately, effectively, and on a sustained basis. To reinforce the principle that this assessment is not tied to a particular number of limited activities, and to address the comments we received, we explain that among the factors we will consider is the quality and level of an individual's overall functional performance. We also include an explicit reference to limitations resulting from episodic illness. Finally, to recognize that there are other factors we will consider, we provide a cross-reference to several paragraphs in the adult mental disorders listings which describe these factors in more detail.

Given all the factors that we consider in rating the degree of functional limitations resulting from an impairment(s), we concluded that the rating scale definitions we had proposed were over simplified. As a result, we deleted them from these final rules. However, we retained and modified the last sentence of proposed §§ 404.1520a(b)(2) and (b)(4)(iii) and 416.920a(b)(2) and (b)(4)(iii). This sentence had stated that the last two points on each scale represent a degree of limitation that is incompatible with the ability to perform the work-related function or (for a child) to perform the function in an age-appropriate manner. The last sentence of final §§ 404.1520a(c)(4) and 416.920a(c)(4) now states that the “extreme” scale point represents a degree of limitation that is incompatible with the ability to do any gainful activity.

The final wording changes two things about the meaning of the sentence. First, it shifts the focus of the sentence from inability to perform particular work-related functions to inability to perform any gainful activity. The final rules reflect the listing-level severity standard in §§ 404.1525(a) and 416.925(a). This is a more severe standard of disability than is necessary to establish disability at the last steps of the sequential evaluation processes for adults. As a result, the final rules clarify that an “extreme” limitation in any one area of functioning means that the individual has an impairment(s) of listing-level severity.

Second, the final rules remove the implication that the next-to-last scale point, a “marked” limitation, can be equated with an “extreme” limitation. Since we shifted the focus of the sentence to listing-level severity, and because an individual must have “marked” limitations in two areas of functioning to be found to have a listing-level impairment, the revision clarifies the distinction between the “marked” and “extreme” degrees of limitation. At least one commenter thought this distinction was unclear in the proposed rules.

Comment:
One commenter pointed out that in proposed §§ 404.1520a(b)(2) and 416.920a(b)(2), we stated that the four functional areas we use to evaluate the functional limitations of adults are “essential” to an adult's ability to work. The commenter asserted that, while each of these areas may have potential applicability to fitness for work, no empirical data exist to substantiate their utility in predicting performance on the job.

Response:
We disagree, but accommodated the comment. The American Psychiatric Association, under contract to us, conducted an independent scientific assessment of the adult mental disorders listings which were revised in August 1985. The findings from the assessment, as reported in 1987, supported continued use of these four criteria when

predicting an individual's inability to do any gainful activity.

Nevertheless, we believe that the language proposed in §§ 404.1520a(b)(2) and 416.920a(b)(2) relating to the assessment of adult claims was more of an observation than a substantive rule and did not significantly add to the rules. Therefore, we deleted it from the final rules. We also clarified the third and fourth paragraphs of final 12.00A by replacing the word “work” with the phrase “do any gainful activity.” In addition, we deleted the word “work” from “gainful work activity” in the first sentence of the sixth paragraph. This will make it clear that the criteria in the listings establish listing-level severity, not just the inability to do any substantial gainful activity. (The references to “work” in the first paragraph of final 12.00A and elsewhere in the section are still correct in their particular contexts.)

Comment:
One commenter recommended that we should continue to consider lay statements when assessing an individual's functional limitations under the revised rules in §§ 404.1520a and 416.920a.

Response:
We did not intend to give the impression that we would stop considering such evidence. Current §§ 404.1513(e) and 416.913(e) acknowledge that information from lay sources may help us to understand how an individual's impairment(s) affects his or her ability to function. We believe that the extensive revisions to final §§ 404.1520a and 416.920a also make clear that we will consider all relevant evidence. These final rules do not change our policy regarding the use of lay statements in assessing the severity of mental impairments.

Comment:
One commenter thought that the first sentence in proposed §§ 404.1520a(c)(3) and 416.920a(c)(3), regarding determinations of equivalence, was inconsistent with our policies on determining equivalence. The commenter said that the sentence indicated that the only consideration in determining equivalence was to be given to the listings themselves, and that this was “a discredited notion.”

Response:
The comment was unclear to us, but it indicated that some of the proposed rules had been misunderstood. For determinations of equivalence, we require our adjudicators to identify particular listed impairments to which an individual's impairment(s) is equivalent in severity. This does not mean that we require the individual to have an impairment cited in the listings, only that some justification must exist for a finding of equivalence. Thus, a comparison to a particular listing must demonstrate that an impairment(s) is equivalent in severity. Nevertheless, since this comment demonstrated that the language could be unclear, we replaced the proposed sentence with two introductory sentences, as we describe in the explanation of final §§ 404.1520a(d)(2) and 416.920a(d)(2).

We also replaced the potentially misleading phrase, “equals the listings,” in proposed §§ 404.1520a(c)(4) and 416.920a(c)(4) with the more accurate “is equivalent in severity to any listing” in final §§ 404.1520a(d)(3) and 416.920a(d)(3). In addition, we deleted the concluding phrase “when appropriate to the category of claim being assessed” from the sentence. All categories of cases involving a severe impairment(s) that neither meets nor is equivalent in severity to any listed impairment require an RFC assessment. Finally, we revised the first sentence of the sixth paragraph and the last sentence of the seventh paragraph of final 12.00A to use similar language to final §§ 404.1520a(d)(2) and 416.920a(d)(2).

Comment:
One commenter asked whether the standard document, the “Psychiatric Review Technique” form (PRTF), will be revised to reflect changes in the listings.

Response:
We have revised the original PRTF wherever necessary to reflect the revisions we made in the final rules for adults.

Comment:
We received a number of comments about the change in proposed §§ 404.1520a(d)(1) and 416.920a(d)(1), which allowed the medical consultant or psychological consultant within the State agency to request disability examiners to assist in the completion of the PRTF. Two of the comments supported the change, noting that it would give State agencies additional flexibility in dealing with workload demands. However, most of the comments opposed the change.

Those who opposed the change gave at least one of the following reasons: (1) The proposal violated the Commissioner's (formerly the Secretary's) duty under section 221(h) of the Act to make every reasonable effort to ensure that the claims of individuals with mental impairments are evaluated by qualified psychiatrists or psychologists; (2) the proposal represented an arbitrary change in past agency policy; and (3) the proposal would lead to less accurate assessments at the State agency level, which would be detrimental to individuals with mental impairments. Most commenters opposed to the proposal recommended that we delete the proposed rule from the final rules.

Response:
We did not adopt the comments that asked us to delete the proposed rule. In response to the comments, however, we clarified final §§ 404.1520a(e)(1) and 416.920a(e)(1).

The final rules now state more clearly that the medical or psychological consultant still has the overall responsibility for assessing the medical severity of the individual's mental impairment(s), even though a disability examiner may assist in preparing the PRTF. The medical or psychological consultant must review and sign the PRTF to attest that it is complete and that he or she is responsible for its content, including the findings of fact and any discussion of supporting evidence. The revision makes it clear that the change is consistent with sections 221(h) and 1614(a)(3)(H)(i) of the Act. These sections of the Act provide that we must make every reasonable effort to ensure that a qualified psychiatrist or psychologist has completed the medical portion of the case review and any applicable RFC assessment in any initial determination in which there is evidence that an individual has a mental impairment, and in which we make a determination that the individual is not disabled. We assess medical severity as part of the medical portion of the case review. The initial preparation of all or part of a PRTF by a disability examiner assisting the physician or psychologist does not constitute part of the medical portion of the case review.

Allowing disability examiners to assist medical consultants or psychological consultants in preparing the PRTF does not change or dilute our statutory responsibility to make every reasonable effort to use medical or psychological consultants. The rules merely give the State agencies the option to utilize the training of their disability examiners so that they can use the expertise of their medical and psychological consultants as efficiently as possible. Disability examiners must be qualified to interpret and evaluate medical reports and other evidence relating to an individual's mental impairment(s). (See the paragraph following §§ 404.1615(c)(3) and 416.1015(c)(3).)

Moreover, the purpose of the statute was to ensure that in cases where there is evidence of a mental impairment, we would make every reasonable effort to have a qualified psychiatrist or psychologist complete the medical portion of the case review and any applicable RFC assessment before we make an initial determination that the

claimant is not disabled. Before Congress enacted sections 221(h) and 1614(a)(3)(H)(i) of the Act, there were no specific requirements in the statute or our regulations concerning the qualifications of medical consultants reviewing claims involving mental impairments. Rather, our regulations at that time simply stated that disability determinations were to be made by a State agency disability team that consisted of a medical consultant (a physician) and a disability examiner. Although the amendments require us to make every reasonable effort to have a qualified psychiatrist or psychologist complete the medical portion of the case review, they do not prohibit a disability examiner from assisting the medical or psychological consultant in the process.

These final rules authorize disability examiners to provide the same assistance in preparing the PRTF that they now provide to consultants in preparing RFC assessments. Disability examiners had been assisting State agency consultants in preparing individualized functional assessment forms in title XVI childhood cases since implementation of the SSI childhood disability rules on February 11, 1991 (56 FR 5534). Nothing in our experience indicates that this assistance had disadvantaged any children in the 6 years between publication of those rules and implementation of the new SSI childhood disability rules on February 11, 1997 (62 FR 6408). Disability examiners also have assisted medical and psychological consultants in preparing the childhood disability evaluation form since implementation of the new SSI childhood disability rules (§ 416.924(g)). Similarly, disability examiners have assisted medical and psychological consultants in preparing RFC forms since August 1, 1991, when we implemented final rules concerning “Standards for Consultative Examinations and Existing Medical Evidence” (56 FR 36932). In both processes, disability examiners have demonstrated their ability to provide valuable assistance, and we believe their expertise will be of similar benefit to the PRTF process. Based on our experience, and our confidence in the qualifications of the State agency disability examiners, we do not believe that individuals will be disadvantaged by allowing State agencies the option of having disability examiners assume similar responsibilities in preparing the PRTF, since the medical or psychological consultant retains overall responsibility for assessing the medical severity of an individual's mental impairment.

Comment:
One commenter stated that proposed §§ 404.1520a(d)(1) and 416.920a(d)(1) were internally inconsistent because each paragraph began with a sentence requiring the medical or psychological consultant to perform the evaluation and complete the standard document, yet in a later sentence allowed the disability examiner to complete the entire document and only required the consultant to sign it. In addition, this commenter opined that since §§ 404.1512(b)(6) and 416.912(b)(6) state that the findings of State agency medical and psychological consultants are considered “medical evidence” at the administrative law judge and Appeals Council levels, disability examiner involvement in completing the PRTF either should be precluded or identified in some fashion, since those recorded findings would not constitute “medical evidence.”

Response:
We clarified final §§ 404.1520a(e)(1) and 416.920a(e)(1) in response to the first part of the comment. We agree that the proposed rules used the phrase “complete the standard document” ambiguously to mean “fill out” the form in some instances and “finalize” (as by signature) in others. The final rules remove this ambiguity.

We do not agree with the commenter's second argument. When the medical or psychological consultant signs the PRTF, his or her signature attests that it is complete and that its entire content represents his or her medical findings. Any entries made by a disability examiner on the PRTF become the findings of the medical or psychological consultant when he or she attests to its completeness and its content by signing the form. Accordingly, the administrative law judge or the Appeals Council (when the Appeals Council issues a decision) will still evaluate these findings using our existing rules (§§ 404.1527(f)(2) and (f)(3), 416.927(f)(2) and (f)(3), and SSR 96-6p).

Comment:
A few commenters questioned our proposal in §§ 404.1520a(d) and 416.920a(d) of the NPRM (final §§ 404.1520a(e) and 416.920a(e)) to eliminate the use of the PRTF at the administrative law judge hearing and Appeals Council levels of the administrative review process. One commenter noted that the proposed sections appeared to direct administrative law judges to incorporate in their written decisions the same information used on the PRTF. This commenter believed that the PRTF ought to satisfy the documentation requirements. The commenter suggested that we revise the section to allow administrative law judges the option of using the PRTF, either in the decision or as an attachment to it. Another commenter indicated that some administrative law judges may find the PRTF a useful checklist and recommended that they be given the discretion to use the form and append it to their decisions. Since only decisions that are likely to undergo further administrative or judicial review are at issue, one commenter suggested requiring the PRTF at least for those decisions.

A few commenters believed that the PRTF has helped to ensure the quality and completeness of hearing decisions, that it is a safeguard against incomplete review of the evidence, and that it assures claimants and advocates that the decision conforms strictly to our rules for evaluating mental impairments.

Response:
We did not adopt the comments. The primary purpose of the final rules is to describe the technique, as distinct from the form, and to require the use of the technique in all determinations and decisions at all levels of the administrative review process, including the hearings and appeals levels. The technique is a systematic process adjudicators apply when evaluating an individual's mental impairment(s). The PRTF (i.e., the form itself) should not be confused with application of the technique; the form simply documents application of the technique with a checklist of our conclusions.

When we first promulgated these rules in 1985, we believed that they were so novel and complex that it would be useful to require all adjudicators at all levels of the administrative review process to complete the PRTF. At the initial and reconsideration levels, the PRTF has proven to be a simple and convenient method of documenting the conclusions reached by our medical and psychological consultants when applying the technique.

Even though we apply the same technique at the administrative law judge hearing and Appeals Council levels as we do at the initial and reconsideration levels, administrative law judge and Appeals Council decisions are quite different in form from determinations prepared by a State agency. Administrative law judge and Appeals Council decisions include a more detailed explanation of the findings and conclusions reached, supported by a narrative rationale. The decisions under these final rules must include, among other things, the pertinent findings and conclusions required in the application of the technique. Consequently, requiring that a PRTF be appended to an

administrative law judge or Appeals Council decision would only repeat information already required in the decision under these final rules, and renders the PRTF redundant. For this reason, these final rules do not require administrative law judges or the Appeals Council to complete the form or to attach the form to their decisions, just as we do not require them to complete or attach RFC assessment forms to their decisions.

We recognize that administrative law judges and members of the Appeals Council may find the PRTF useful as a checklist and for organizing information in the record. These final rules do not prohibit the use of the form at the hearings and appeals levels to assist the decisionmaker in applying the technique and issuing a decision.

Comment:
A few commenters objected to our proposal to delete the special administrative law judge remand provision of prior §§ 404.1520a(d)(1)(iii) and 416.920a(d)(1)(iii). Most of these commenters thought that we should retain a provision giving administrative law judges the option to remand cases to the State agencies when new evidence is received at the hearing level that is not merely cumulative of evidence already in the case file, or when the issue of a mental impairment first arises at the hearing level.

Two of these commenters, in identical language, said that the omission of the prior remand provision would make it “less likely that an administrative law judge would consider new evidence at all.” The same two commenters thought that the deletion of the prior provision left it unclear whether administrative law judges would be required to evaluate the new evidence without the assistance of the State agency. Another commenter said that the deletion of the provision would result in the issuance of more decisions without fully developed evidence and cause more remands by the Appeals Council and the Federal courts.

One commenter suggested that we strengthen the prior provision instead of deleting it. The commenter provided language for the rules that would require administrative law judges to remand cases in most instances in which new evidence at the hearing level raised the issue of a mental impairment for the first time. Conversely, one commenter thought that proposed §§ 404.1520a(d)(3) and 416.920a(d)(3), which provided for remand to the State agency for completion of the standard document only when an administrative law judge was unable to obtain the services of a medical expert, was too broad. The commenter believed that returning a case to the State agency for completion of the standard document is very time-consuming and could result in nothing more than a second reconsideration. The commenter suggested that we revise our regulations to prevent this.

Two commenters thought the reference to §§ 404.948(c) and 416.1448(c) in proposed paragraph (d)(3) was not a substitute for the deleted provision. One of these commenters challenged the statement in the preamble of the proposed rules (56 FR at 33131) which said that the former administrative law judge remand provision could be deleted because it covers “what is already covered in §§ 404.941, 404.948, 416.1441, and 416.1448.” This commenter stated that §§ 404.948 and 416.1448 discuss issuing decisions that are fully favorable to the claimant without an oral hearing and have no relevance to the issue of evidence of a mental impairment first being submitted at the hearing level. The commenter also noted that §§ 404.941 and 416.1441, which discuss prehearing case reviews, are pertinent only when additional evidence is submitted before a scheduled hearing, so sufficient time remains to conduct the review and decide how to address the issues involved.

Response:
We understand the commenter's concerns. However, in light of our experience, we do not believe that the prior rules allowed more flexibility and efficiency in resolving claims. Further, the former provisions went beyond their intended scope; i.e., how an administrative law judge can get assistance in applying the technique when the services of a medical expert are needed but unavailable. Although we did not adopt the comments, we clarified final §§ 404.1520a(e)(3) and 416.920a(e)(3).

We agree with the commenter who observed that the provisions in §§ 404.941, 404.948, 416.1441, and 416.1448 are somewhat different from those in §§ 404.1520a(d)(1)(iii) and 416.920a(d)(1)(iii) of the prior rules. All discuss the administrative law judge's return of a case to the State agency for further consideration. The return of a case to the State agency for a prehearing case review, which is described in §§ 404.941 and 416.1441, does not delay the scheduling of a hearing. Under this provision, we may return the case to the State agency before the hearing is held, when there is reason to believe that a revised determination wholly or partially favorable to the individual may result. The State agency can then decide whether or not to revise its prior determination. The prehearing case review will not delay the scheduled hearing unless the individual agrees. Similarly, the administrative law judge remand procedure described in §§ 404.948(c) and 416.1448(c) is also designed for speedy claim resolution. It allows an administrative law judge to return a case to the State agency for a revised determination without an oral hearing when there is reason to believe the revised determination would be fully favorable to the individual. In such a case, the individual is notified of the remand and afforded the opportunity to object to it.

In contrast, under the special remand provision in §§ 404.1520a(d)(1)(iii) and 416.920a(d)(1)(iii) of the prior rules, in certain instances an administrative law judge could remand a case involving a mental impairment to the State agency for completion of the standard document and a revised determination. The revised determination the State agency could issue upon remand could be unfavorable to the individual and the individual would be required to request another hearing if he or she wished to pursue his or her claim. Ironically, when we proposed the special remand provision in former §§ 404.1520a(d)(1)(iii) and 416.920a(d)(1)(iii) in 1985, most commenters opposed it, primarily because they were concerned that it would cause undue delay in our decisionmaking (50 FR at 35047).

In fact, we did not intend for the scope of the prior rules to go beyond the established rules in §§ 404.941, 404.948, 416.1441, and 416.1448, although such an interpretation of the prior rules was possible. Our response to comments to the final rules published in 1985 shows that we intended the prior sections to be applied within the context of our rules on prehearing case reviews and decisions without oral hearings, and that it not delay the decisionmaking process. We responded: “We believe the remand procedure is consistent with current practice at the hearings level” and “[b]ased upon our past experience with the need to remand cases, undue delay should not occur in the disability decision-making process.” (50 FR at 35047.) Thus, we did not intend to expand the remand procedures in 1985. All we have done in final §§ 404.1520a(e)(3) and 416.920a(e)(3), is to make clear our original intent to provide the least time-consuming means of issuing a favorable decision.

We strongly disagree with the comments that suggested the deletion of the former administrative law judge remand provision from these final rules will result in mental impairment issues first raised at the hearing level being

ignored, inadequately developed, or not fully analyzed by administrative law judges. Nor do we agree that this provision will result in more remands at the Appeals Council and Federal court levels. We believe that our existing rules make it clear that all adjudicators, including administrative law judges, are required to consider all relevant evidence and to develop the record fully.

While it is more efficient for an individual to submit evidence relating to a new issue at the time he or she files a request for hearing, or at least prior to a scheduled hearing, we recognize that this does not always occur. Sections 404.936, 404.944, 416.1436, and 416.1444 provide that an administrative law judge may adjourn, postpone, or reopen the hearing at any time before notice of the decision is released in order to receive or obtain new and material evidence. Presented with insufficient evidence to determine the nature and severity of an individual's mental impairment(s), an administrative law judge must follow our existing rules and seek additional evidence from appropriate sources, regardless of whether we were aware of the mental impairment(s) at the time the initial and reconsideration determinations were issued.

Finally, we disagree with the comment indicating that returning the case to the State agency for completion of a PRTF will result in nothing more than a second reconsidered determination and unnecessary delays. We believe the procedures in these rules are no more time-consuming than the former rules, and in some cases may actually save time. Nevertheless, we have clarified final §§ 404.1520a(e)(3) and 416.920a(e)(3) by deleting the reference to the remand provisions in §§ 404.948(c) and 416.1448(c), and avoiding the use of the word “remand” since it may imply that the administrative law judge is requesting a revised determination in every case. The final rules indicate that the State agency will issue a revised determination if a decision favorable to the claimant is warranted based on a review of the case file, so as not to delay the payment of benefits. Otherwise, the State agency will return the case, with a completed PRTF, to the administrative law judge, who will proceed with a hearing and issue a decision.

11.00F Traumatic Brain Injury (TBI)

Comment:
Several commenters addressed the proposed rules in 11.00F that required deferral of determinations of disability for up to 6 months in cases of TBI unless a favorable determination could be made sooner. Some were pleased with the proposal. One commenter recommended that we revise the proposed rules to ensure that all TBI cases are not placed in the deferred adjudication categories. Another asked if we would add a provision to deny TBI cases at 3 months or earlier if there is no allegation or medical evidence of an impairment that is more than “not severe.” Four commenters suggested that we find individuals whose cases we defer to be presumptively eligible for disability payments, thus giving them access to health care under Medicaid and other services for which they might be eligible.

Response:
We did not adopt the comments that asked us to change the proposed rules or provide presumptive disability payments to people with TBI. We intentionally required evidence at least 6 months post-injury before we can deny a TBI claim, even when the individual's allegation or the immediate posttraumatic medical evidence suggests the impairment is “not severe.” We decided to allow for the deferral of adjudication of such cases because of the variability and uncertainty of recovery from TBI. We believe the initial 3-month period for deferral (when the individual does not have a profound neurological impairment permitting an earlier finding of disability) and, if necessary, an additional 3-month period, will allow sufficient time for the impairment(s) to stabilize so we can make an accurate projection regarding its severity and duration.

The rule in 11.00F, however, does not prevent us from finding disability sooner on the basis of some other impairment. For example, if an individual has a serious accident with multiple injuries including TBI, the nature and expected course of the additional impairment(s) may support a finding of disability within 3 months post-injury, regardless of any impairment(s) resulting from the brain injury.

Finally, we did not adopt the suggestion to make individuals with TBI presumptively eligible for disability payments while adjudication of their cases is being deferred. Presumptive disability payments are authorized only under title XVI, the SSI program, and would not apply to individuals who file claims only under title II. The rules for presumptive disability in the SSI program are set out in §§ 416.931 through 416.934.

We are not amending these rules to reflect this comment. As we explain in § 416.933, we may make a finding of presumptive disability when the evidence reflects a “high degree of probability” that an individual is disabled. The reason we will defer some determinations in TBI cases, however, is that it is not clear whether the individuals are disabled because of the variable and uncertain nature of their impairments. Thus, the evidence does not reflect the requisite degree of probability of disability for presumptive eligibility under our rules. The commenter's suggestion that providing Medicaid and other medical resources to individuals with TBI may be more cost-effective in the long run may be sound, but we have decided that in this instance claimants will not have presented evidence demonstrating a high degree of probability that they are disabled.

Comment:
One national organization submitted technical medical comments about TBI and our proposed rules that it had solicited from several professionals. One of the comments included a statement that our disability evaluation criteria poorly served individuals with TBI and a recommendation that we restructure the criteria so that TBI “patients do not fall through the cracks.”

Response:
Many of the comments submitted by the organization related to the current neurological listings, rather than the proposed revisions to the mental listings. Accordingly, those comments are outside the scope of this rulemaking proceeding. We are in the process of reviewing the neurological listings criteria and will consider these comments as part of that process.

Some of the comments addressed the prior mental disorders listings, and we address most of those comments below. A few were comments about criteria in the prior mental listings that we had already proposed to change in the NPRM, some in ways very similar to those suggested in the comments. We did not summarize those comments below because the proposed rules had already addressed their concerns.

We share the commenter's concern about individuals with TBI. As a result, we proposed the new 11.00F in the preface to the neurological listings, which includes rules that are unusual in our program because they provide for the deferral of adjudication of such claims, even when it appears that the individual may not have a significant impairment. Furthermore, we added a paragraph to the preface of the mental disorders listings that provides a cross-reference to the new guidance in 11.00F. This cross-reference reminds adjudicators that cases of TBI can be more complex and may involve both mental and physical impairments. We

believe that these provisions of the final rules will help ensure that individuals with TBI “do not fall through the cracks.”

Although we do not have a comprehensive list of all the various neurological and mental impairments that can be associated with TBI, we believe that the possible manifestations of TBI are covered in various listings in 11.00 (the neurological listings) and 12.00 (mental disorders). Indeed, other comments submitted by the organization seemed to agree with this conclusion. However, as we have said, we will also consider the comments about our current neurological listings as we review those listings. Finally, in response to this comment, we revised the heading of final 11.00F from the proposed “Cerebral trauma” to “Traumatic brain injury (TBI)” to make the subject of the section clearer.

Comment:
One commenter noted that listing 12.02, “Organic mental disorders,” applies to individuals with TBI but suggested that we include some types of affective disorders and mood aberrations in the listing. The commenter was aware that listing 12.04 expressly covers mood disorders, but was concerned that it would not apply to people with TBI.

Response:
We did not adopt the comment because listing 12.02A5, “Disturbance in mood,” already includes mood disturbances in the listing for organic mental disorders. In addition, even though listing 11.18 does not refer to listing 12.04 for evaluating an individual with cerebral trauma, we can use listing 12.04 to evaluate a claim involving TBI if the individual has a medically determinable mood disorder.

Comment:
An individual submitted several comments, a complete clinical reference text, and chapter abstracts from a draft book on numerous aspects of TBI and related neuropsychological impairments. Some comments referred to proposed 11.00F, while others referred to other parts of the proposed rules as they relate to TBI. In general, the commenter approved of the separate discussion of TBI in proposed 11.00F, including our recognition of the fact that symptoms evolve over time. However, the commenter believed that the DSM-III-R, upon which the diagnostic criteria in proposed listing 12.02 were based, did not capture the full range of psychopathology associated with TBI. The commenter found the term “organic mental disorders” vague, overly inclusive, and archaic. The commenter recommended that the listing specify the etiology of the trauma and the range of dysfunctions as determined by modern neuropsychological research and clinical experience.

Response:
We thank this commenter for the favorable comments and for all the reference materials, which present an excellent discussion of many of the problems associated with evaluating TBI. Our goal in proposed 11.00F was to provide additional guidance to address these problems, and we appreciate that the commenter finds the paragraph helpful. With respect to the diagnostic criteria found in listing 12.02, however, we do not share this commenter's view of the DSM-III-R. Nor do we believe that this mental disorder listing, or any other, needs to refer specifically to etiology or to the entire range of symptoms determined by research and clinical experience.

As we explained in the preambles to these rules when they were proposed (56 FR at 33130) and the final rules revising the childhood mental disorders listings (55 FR at 51214, 51215), we used the DSM-III-R as the basis for the diagnostic criteria in our mental disorders listings because this reference manual is widely used and accepted in the psychiatric and psychological communities. We believe the common understanding it provides makes it the most useful resource for these listings. We recognize that some clinicians may prefer greater diagnostic specificity than that found in the DSM-III-R (or DSM-IV) or these listings. Nevertheless, as we also explained in the preambles, the diagnostic criteria in the mental disorders listings are not bound by those in the DSM-III-R (or DSM-IV), nor was it our purpose to include every mental impairment or every symptom or sign of the disorders that are listed. The focus of our disability programs is to determine the extent of the functional limitations imposed by a medically determinable impairment(s). Hence, instead of attempting to catalogue every possible mental impairment, these listings provide examples of some of the impairments we consider severe enough to be disabling under our program requirements. We do not discount impairments that are not listed; we evaluate them using our rules for equivalence.

In selecting the diagnostic criteria for these listings, we employ an atheoretical approach with regard to etiology, primarily because our program focus is on functional limitations, and etiology is therefore of less significance to us. Also, we believe it would be very difficult, if not impossible, to obtain evidence relating to the pathophysiologic processes of all the mental disorders we evaluate. Further, we recognize that etiology may be a controversial area for some mental disorders. Thus, its introduction into our criteria might prove to be an obstacle to clinicians of varying theoretical orientations.

Comment:
The same commenter believed that professionals who make disability determinations should be aware of the mechanism of brain trauma, its pathophysiological and pathoanatomical effects, and the proper documentation (within the scope of their own professions) of neurobehavioral impairment and the emotional effects of accidents and of being impaired. The commenter recommended that we establish specialty qualifications for these professionals, such as special neuropsychological training or certification as a Diplomate in Clinical Neuropsychology for psychologists.

Response:
We agree that the professionals who make our disability determinations should be properly trained to evaluate all types of impairments. This includes TBI, with all the factors the commenter described. We disagree, however, that we need additional qualifications for these professionals. Our current qualification standards for medical and psychological consultants are outlined in §§ 404.1616 and 416.1016. We do not believe it necessary or practicable to establish more stringent standards for those who would evaluate one type of impairment. To do so would restrict the pool of qualified specialists available to State agencies.

Nevertheless, we recognize that TBI cases can be difficult to evaluate. That is one reason we included 11.00F in these rules. We have issued guidance for evaluating these cases in the past, and we will issue internal operating guidelines and training material to supplement the information in final 11.00F to ensure that all professionals who evaluate cases involving TBI have the latest information. We also will provide additional guidance to any State agencies requesting clarification of specific issues.

Comment:
The same commenter stated that TBI is “best documented through a wide range examination, including a thorough interview.” The commenter pointed out that using single tests in isolation, without baseline evidence, is below the standards of acceptable practice because test results must be considered in the context of the interview, the individual's IQ, and his or her educational and vocational background. The commenter also provided detailed information about the kinds of evidence that would be necessary to establish a thorough record

in TBI cases and standards for establishing the validity of testing. The commenter encouraged the use of documentation supplied by health care providers.

Response:
We agree that TBI is best documented by a comprehensive examination which includes a thorough interview. We also agree that considering single tests in isolation is inappropriate and that all test results must be considered in the context of all other evidence to establish a complete picture of the individual's impairment and level of functioning.

We also agree that tests should have suitable psychometric standards and should be supplemented by useful qualitative procedures. For this reason, when we proposed revisions to the mental disorders listings, we incorporated existing operating instructions regarding the salient characteristics of a good test into the sixth paragraph of proposed 12.00D. This paragraph, final 12.00D5c, concludes with a sentence which states: “In considering the validity of a test result, we should note and resolve any discrepancies between formal test results and the individual's customary behavior and daily activities.”

Comment:
The same commenter expressed concern about the evaluation of children with TBI. He noted that an undeveloped and thus resistive or disorganized child may not be able to take a conventional psychological examination, and this inability to be tested may itself be a sign of dysfunction.

Response:
We agree with this commenter's observations. One very important policy principle in our rules, which we follow in both childhood and adult claims, is that the evaluation of evidence should result in an assessment of the individual's functioning on a longitudinal basis. We recognize that single examinations and tests may or may not accurately reflect an individual's ability to function in normal settings. This policy principle is reflected in 112.00D of the childhood mental listings, as well as in our rules for evaluating disability in children under title XVI, beginning at § 416.924.

12.00 Mental Disorders

12.00B Need for Medical Evidence

Comment:
One commenter suggested that we expand the definition of psychiatric signs in the third sentence of proposed 12.00B to include reference to specific abnormalities of “attention” and “perception.”

Response:
We partially adopted the comment. We modified the sentence in final 12.00B to indicate that the specific abnormalities cited are examples, not an all-inclusive list, and we revised the examples in the section. In response to the comment, we changed the example of contact with reality to an example of abnormality of perception.

In selecting examples of psychological abnormalities to include in the final definition of psychiatric signs, we did not add “abnormalities of attention” because it is covered by “abnormalities of behavior.” However, we substituted the suggested “abnormalities of perception” for our prior reference to “abnormalities of contact with reality” because “abnormalities of perception” is a more specific example. We also changed “abnormalities of affect” to “abnormalities of mood” to reflect current diagnostic nomenclature. We added abnormalities in “development” to the list because some psychological abnormalities are first evident in childhood and continue into adulthood.

The third sentence of 12.00B was an exact restatement of the third sentence of §§ 404.1528(b) and 416.928(b), the regulations that define the term “signs,” and was also repeated in 112.00B of the childhood mental listings. Therefore, to reflect the changes in final 12.00B, we made similar modifications to the definition of psychiatric signs in those sections.

Comment:
One commenter was concerned that we cited psychiatrists and psychologists as the only examples of appropriate medical sources in the third sentence of proposed 12.00B. The commenter said that many medical personnel, such as nurses, social workers, and physicians' assistants, are qualified to recognize signs of mental impairment. Another commenter suggested that we include physiatrists and neurologists in the list of examples.

Response:
We accommodated the comments. We agree that no relevant source of evidence should be overlooked when developing claims involving mental impairments. Our intent in providing the two specific examples of appropriate medical sources in proposed 12.00B was not to diminish the value of evidence provided by other sources, but to identify which of the acceptable medical sources cited in §§ 404.1513(a) and 416.913(a) usually provide evidence in claims involving mental impairments. While we could have cited other physicians, such as physiatrists and neurologists, in this list of examples, we would not have included nurses, social workers, and physicians' assistants in the list. The latter are defined as “other sources” of evidence in §§ 404.1513(e) and 416.913(e) and are not “acceptable medical sources” who can provide evidence to establish the existence of a medically determinable mental impairment. Such sources can, however, provide very valuable information about the severity of an impairment(s) once the existence of such an impairment has been established with evidence from an “acceptable medical source.”

As a result of these two comments, we again looked at the need to provide specific examples of appropriate medical sources in 12.00B. Since the purpose of this section of the preface to the listings is to discuss the need for medical evidence and not who can supply it, we decided it was unnecessary to provide any examples and deleted those we had proposed from the third sentence of final 12.00B.

12.00C Assessment of Severity

Comment:
We received five comments about our proposal to change the example of a marked limitation in activities of daily living in the second paragraph of proposed 12.00C1. All of the commenters asked us to retain the prior example of an individual who is able to cook and clean but is too fearful to leave the immediate environment of home and neighborhood, saying that it was still useful and appropriate. In addition, most did not object to our retaining the proposed example of an individual who cannot perform a “wide range of daily activities * * * independently.” However, one commenter thought that the proposed example was too imprecise to be useful.

Response:
We did not adopt the comments asking us to restore the prior example, but we have replaced the example in the second paragraph of final 12.00C1 with more descriptive text in response to the last comment.

We did not reinstate the example from the prior rules because it describes a person with agoraphobia. We agree with the commenters that it is still an appropriate example of a marked limitation in activities of daily living. Nonetheless, we deleted it because we were concerned that, as the sole example, its specificity could result in too narrow an interpretation of what constitutes a marked limitation in this area.

We agree with the last commenter that the example we proposed required too many factual assumptions about what constituted independence and a “wide range of daily activities” to be helpful. Therefore, in the final rules, we replaced the proposed example with a sentence describing some of the considerations for assessing limitations in activities of daily living. We believe that this descriptive approach will be

more helpful than any example providing a single, narrow fact pattern.

Comment:
One commenter suggested that the discussion of task completion in proposed 12.00C3 should also address the quality and accuracy of the tasks being completed, as well as their timeliness.

Response:
We adopted the comment. In the first sentence of the first paragraph of final 12.00C3, we inserted the words “and appropriate” between the words “timely” and “completion.” Thus, the final sentence defines concentration, persistence, or pace in terms of the individual's ability to sustain focused attention and concentration of sufficient length to permit the timely and appropriate completion of tasks commonly found in work settings.

We also added a new fifth paragraph to final 12.00C3 similar to the paragraphs in 12.00C1 and 12.00C2 that define the term “marked” by “the nature and overall degree of interference with function.” The new paragraph indicates that we may find a marked limitation in concentration, persistence, or pace even though the individual can complete many simple tasks if the impairment nonetheless interferes seriously with the individual's ability to complete those tasks in accordance with quality and accuracy standards. However, the provision also states that deficiencies in concentration, persistence, or pace that are apparent only in performing complex tasks would not necessarily satisfy the intent of the paragraph B3 criterion. An individual who is unable to do complex tasks, but who is able to do simple tasks independently, appropriately, and effectively, may or may not be disabled, and may not have a “marked” limitation in concentration, persistence, or pace.

Comment:
Several comments addressed the proposal to reverse the order of the second and third sentences of prior 12.00C3 and to characterize the ability to complete household tasks as an “example” of a way to assess a person's ability to concentrate under this criterion. The commenters pointed out that individuals who cannot tolerate work stress may nevertheless be able to complete household tasks. Two commenters noted that the proposed example was illogical in context because it followed a sentence that explained that difficulties in task completion are best observed in “work and work-like” settings. The commenters believed that the household is not a work-like setting. One commenter thought that in the prior rules the reference to household routines made sense because it came before the statement about the observation of deficiencies in work or work-like situations, not after.

One commenter recommended that we delete the example. T

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A00-19648. Public record. Not legal advice.