Revised Medical Criteria for Evaluating Musculoskeletal Disorders, 20646-20673 [2018-08889]

Download as PDF 20646 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules SOCIAL SECURITY ADMINISTRATION 20 CFR Parts 404 and 416 [Docket No. SSA–2006–0112] RIN 0960–AG38 Revised Medical Criteria for Evaluating Musculoskeletal Disorders Social Security Administration. Notice of proposed rulemaking. AGENCY: ACTION: We propose to revise the criteria in the Listing of Impairments (listings) that we use to evaluate claims involving musculoskeletal disorders in adults and children under titles II and XVI of the Social Security Act (Act). These proposed revisions reflect our adjudicative experience, advances in medical knowledge and treatment of musculoskeletal disorders, and recommendations from medical experts. DATES: To ensure that your comments are considered, we must receive them no later than July 6, 2018. ADDRESSES: You may submit comments by one of three methods—internet, fax, or mail. Do not submit the same comments multiple times or by more than one method. Regardless of which method you choose, please state that your comments refer to Docket No. SSA–2006–0112 so that we may associate your comments with the correct regulation. Caution: You should be careful to include in your comments only information that you wish to make publicly available. We strongly urge you not to include in your comments any personal information, such as Social Security numbers or medical information. 1. Internet: We strongly recommend that you submit your comments via the internet. Please visit the Federal eRulemaking portal at https:// www.regulations.gov. Use the Search function to find docket number SSA– 2006–0112. The system will issue you a tracking number to confirm your submission. You will not be able to view your comment immediately because we must post each comment manually. It may take up to a week for your comment to be viewable. 2. Fax: Fax comments to (410) 966– 2830. 3. Mail: Address your comments to the Office of Regulations and Reports Clearance, Social Security Administration, 107 Altmeyer Building, 6401 Security Boulevard, Baltimore, Maryland 21235–6401. Comments are available for public viewing on the Federal eRulemaking portal at https://www.regulations.gov or daltland on DSKBBV9HB2PROD with PROPOSALS3 SUMMARY: VerDate Sep<11>2014 21:10 May 04, 2018 Jkt 244001 in person, during regular business hours, by arranging with the contact person identified below. FOR FURTHER INFORMATION CONTACT: Cheryl A. Williams, Office of Disability Policy, Social Security Administration, 6401 Security Boulevard, Baltimore, Maryland 21235–6401, (410) 965–1020. For information on eligibility or filing for benefits, call our national toll-free number, 1–800–772–1213, or TTY 1– 800–325–0778, or visit our internet site, Social Security Online, at https:// www.socialsecurity.gov. This notice of proposed rulemaking (NPRM) is divided into several parts. First, we provide the supplementary information, which is often referred to as the preamble. In the preamble, we explain why we propose to revise the listings for the musculoskeletal body system and how we developed the proposed rules. We also offer a narrative of the changes we are proposing. The preamble tells the story behind the proposed rule changes, but if we decide to proceed with a final rule, the preamble will not become part of the Code of Federal Regulations. The next section is the proposed revisions to the listing of impairments, located in Appendix 1 to Subpart P of 20 CFR part 404. For each body system affected by these proposed rules (e.g., 1.00 Musculoskeletal Disorders), we first provide proposed changes to the introductory text (e.g., 1.00A, B, C, etc.). If we decide to proceed with a final rule, the introductory text will become part of the Code of Federal Regulations. The introductory text details which disorders we evaluate and what evidence we need to conduct this evaluation. It also defines certain terms, and provides valuable background information. Individuals often refer to the introductory text for additional details related to a specific listing under which a medically determinable impairment (MDI) is being evaluated. After the introductory text, we provide specific listing text and criteria (e.g., 1.15 and 1.16). The listings themselves provide specific criteria that an MDI must meet (or medically equal) in order for an individual to be found disabled under the listings. SUPPLEMENTARY INFORMATION: I. Why are we proposing to revise the listings for the musculoskeletal body system? We last published final rules that revised the musculoskeletal body system on November 19, 2001.1 We are 1 66 FR 58010. We also made a conforming change to the rules for musculoskeletal disorders PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 now proposing to update the introductory text and criteria in the current listings to reflect our adjudicative experience, advances in medical knowledge and treatment of musculoskeletal disorders, and comments and recommendations from medical experts. While we believe our proposed revisions reflect advances in medical knowledge and treatment of musculoskeletal disorders, we are interested in receiving public comments on the following issues: • Are there any musculoskeletal disorders that will meet one of the proposed listings, but are generally expected to medically improve after a certain amount of time to the point at which the disorders will no longer be of listing-level severity? If you believe there are musculoskeletal disorders that fit into this category, please tell us by submitting your comments and any supporting research or data. We will use your comments on this issue to inform our policy on the timing of continuing disability reviews.2 • Are the proposed functional criteria appropriate and sufficient for assessing listing level severity? If you believe the proposed functional criteria are either insufficient for documenting an impairment that meets a listing-level severity, or you believe these criteria will exclude eligible individuals with an impairment of listing-level severity, please tell us by submitting your comments and any supporting research or data. • Did we remove or omit any valuable information that should be included in the introductory text? We intend for this text to ease administrative burdens for adjudicators, claimants, claimant representatives, and the public by clarifying terms, removing extraneous language, and providing guidance in an orderly fashion. If you believe we removed or omitted any valuable information, please tell us by submitting your comments and any supporting research or data. • Should any of the proposed listings for musculoskeletal disorders be combined into one listing or divided into multiple listings for adjudicative ease and capture individuals with impairments that meet a listing-level severity? If you believe our listing categories create unnecessary administrative barriers for impairments that meet listing level severity, please when we published final rules revising the rules for immune system disorders on March 18, 2006 (73 FR 14570). 2 See §§ 404.1590 and 416.990 of this chapter for our policy on when we will conduct a continuing disability review. E:\FR\FM\07MYP3.SGM 07MYP3 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules daltland on DSKBBV9HB2PROD with PROPOSALS3 tell us by submitting your comments and any supporting research or data. • Did we appropriately define ‘‘close proximity of time’’ in section 1.00C7 as meaning that all of the relevant criteria have to appear in the medical record within a period not to exceed 4 months of one another for musculoskeletal disorders? The 4-month threshold represents a period in which an individual receiving treatment for a chronic severe musculoskeletal impairment will undergo multiple examinations or treatments from their medical source(s). Individuals with chronic severe musculoskeletal impairments typically undergo multiple examinations or treatments. Therefore, we believe a 4-month threshold provides individuals with adequate time to receive multiple medical treatments documenting the existence of listing level criteria, should the relevant criteria exist. If you believe the ‘‘close proximity of time’’ should be defined by a different measure than 4 months, please tell us by submitting your comments and any supporting research or data. • Based on advances in medical surgical, recuperative, and functionally restorative treatment of musculoskeletal disorders, would the proposed listing criteria allow us to adequately assess whether an individual has achieved ‘‘maximum benefit from therapy’’ or whether an individual is ‘‘under continuing surgical management’’? It is important that we do not encourage or incentivize individuals to increase their medical treatment to maintain or access disability benefits, particularly medical treatments that would likely be ineffective, or that may even be harmful, for the individual? If you believe ‘‘the maximum therapeutic benefits’’ criterion should be revised and evaluated by a different measure, please tell us by submitting your comments and any supporting research or data. II. How did we develop these proposed rules? As medicine and medical treatment are continuously evolving, we utilized well-known references such as the Guides to the Evaluation of Permanent Impairment from the American Medical Association, Harrison’s Principles of Internal Medicine, Current Diagnosis & Treatment in Orthopedics, and Nelson Textbook of Pediatrics as a starting point to develop the proposed changes to these rules.3 We also requested extensive input from our medical consultants (physicians employed by or 3 Full citations are available in X. References below. VerDate Sep<11>2014 21:10 May 04, 2018 Jkt 244001 who contract with us) who have years of experience practicing in relevant fields of medicine and who have intimate knowledge of our disability programs to develop our proposed changes to the musculoskeletal disorders listings. We rely on our medical consultants and their professional opinions based on their clinical experience and research to help us develop what criteria correspond with listing-level severity. In developing our proposed rule changes, we used the resources above, our programmatic knowledge, our adjudicative experience, and the medical literature, such as Archives of Physical Medicine and Rehabilitation, Journal of the American Academy of Orthopaedic Surgeons, and Hand Clinics. These resources informed us of the most recent best practices and medical advancements and either support, or are consistent with, our proposed rule changes. In addition to these distinguished medical sources and our medical consultants, in proposing these changes to the musculoskeletal disorders listings, we used information from: • People who make and review disability determinations and decisions for us in State agencies, in our Office of Quality Review, and in our Office of Hearing Operations; • Comments we received regarding the 2001 ‘‘Final rules with request for comment,’’ 4 which we used as a starting point for identifying areas needing further research; and • Additional published sources we list in the References section at the end of this preamble, including the National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division (formerly the Institute of Medicine). III. What major revisions are we proposing? We propose to revise both the content and the structure of the adult and childhood musculoskeletal disorders listings and introductory texts as follows: • Provide uniform and specific severity criteria for evaluating the effects of a musculoskeletal disorder on a person’s functioning; • Revise the introductory texts in 1.00 Musculoskeletal Disorders and 101.00 Musculoskeletal Disorders to provide guidance on the specific severity criteria; 4 The final rules with request for comments are available at https://www.gpo.gov/fdsys/pkg/FR-200111-19/pdf/01-28456.pdf. Comments on the final rules may be found at https://www.regulations. gov/, and search for ‘‘SSA–2006–0112’’. PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 20647 • Add specific sections in the introductory texts in 1.00 Musculoskeletal Disorders and 101.00 Musculoskeletal Disorders to provide guidance on each listing; • Revise the content and structure of the current listings to incorporate the new severity criteria into each listing; • Add listings for evaluating pathologic fractures due to any cause (1.19 Pathologic fractures due to any cause for adults and 101.19 Pathologic fractures due to any cause for children); • Add a child listing for evaluating musculoskeletal disorders of infants and toddlers, from birth to attainment of age 3, with developmental motor delay (101.24 Musculoskeletal disorders of infants and toddlers, from birth to attainment of age 3, with developmental motor delay); • Use the same general structure in most adult and child listings, consisting of symptoms, signs, laboratory findings, and applicable functional criteria, in that order; • Remove current 1.02 and 101.02 Major dysfunction of a joint(s) (due to any cause) and incorporate the provisions in proposed 1.18 and 101.18 Abnormality of a major joint(s) in any extremity; • Remove current 1.04 Disorders of the spine and 1.04A ‘‘Evidence of nerve root compression,’’ and incorporate the provisions of 1.04A in proposed 1.15 Disorders of the skeletal spine resulting in compromise of a nerve root(s); • Remove current 1.04B ‘‘Spinal arachnoiditis’’ because it is a secondary effect, rather than a primary skeletal spine disorder, which can be evaluated under proposed 1.16 Lumbar spinal stenosis resulting in compromise of the cauda equina; • Remove current 1.04C ‘‘Lumbar spinal stenosis,’’ and incorporate its provisions in proposed 1.16 Lumbar spinal stenosis resulting in compromise of the cauda equina; • Remove current 101.04 Disorders of the spine and incorporate the provisions in proposed 101.15 Disorders of the skeletal spine resulting in compromise of a nerve root(s) and 101.16 Lumbar spinal stenosis resulting in compromise of the cauda equina; • Remove current 1.05 and 101.05 Amputation (due to any cause), and incorporate its provisions in proposed 1.20 and 101.20 Amputation due to any cause; • Remove current 1.06 and 101.06 Fracture of the femur, tibia, pelvis, or one or more of the tarsal bones; and incorporate the provisions of those listings in proposed 1.22 and 101.22 Non-healing or complex fracture of the E:\FR\FM\07MYP3.SGM 07MYP3 20648 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules femur, tibia, pelvis, or one or more of the tarsal bones; • Remove current 1.07 and 101.07 Fracture of an upper extremity; and incorporate the provisions of those listings in proposed 1.23 and 101.23 Non-healing or complex fracture of an upper extremity; and • Remove current 1.08 and 101.08 Soft tissue injury (e.g., burns), and incorporate the provisions in proposed 1.21 and 101.21 Soft tissue injury or abnormality under continuing surgical management. IV. What changes are we proposing to the introductory text of the musculoskeletal disorders listings for adults? We propose to adopt a question-andanswer framework to make the guidance contained in the introduction easier for adjudicators, claimants, claimant representatives, and the public to locate, and to make the introductory text consistent with the format used in other body systems. We propose to remove the phrases ‘‘loss of function’’ and ‘‘functional loss’’ and replace the content of current 1.00B1 General, 101.00B1 General, 1.00B2 How we define loss of function in these listings, and 101.00B2 How We Define Loss of Function in These Listings. We are replacing the content of 1.00B1 General and 101.00B1 General because it may be read to imply that we require an absence of function in order to evaluate an impairment under these listings. Except in the case of amputation, the proposed listings do not require a complete absence of function. In 1.00B2 How We Define Loss of Function in These Listings and 101.00B2 How We Define Loss of Function in These Listings, we are removing the descriptive phrases, ‘‘inability to ambulate effectively,’’ ‘‘extreme limitation of the ability to walk,’’ ‘‘interferes very seriously with the individual’s ability to independently initiate, sustain, or complete activities,’’ ‘‘ineffective ambulation,’’ and ‘‘independent ambulation,’’ along with the corresponding examples in that paragraph. We are replacing these descriptors with uniform and specific severity criteria, which we believe will provide clearer guidance for adjudicators and the public. We propose to provide new uniform and specific functional criteria, which we describe in the introductory text for each listing, for evaluating the severity of limitations caused by musculoskeletal disorders. We chose these particular functional criteria because they clearly illustrate the level of dysfunction for upper and lower extremities that would cause an adult to be unable to work, or that would cause a child to be unable to perform ageappropriate activities. The effects of a particular disorder on musculoskeletal functioning, and the treatment needed, direct which of these criteria are appropriate for each of the listings. The functional criteria for adults are as follows: 1. A documented medical need for a walker, bilateral canes, or bilateral crutches; 2. An inability to use one upper extremity to independently initiate, sustain, and complete work-related activities involving fine and gross movements, and a documented medical need for a one-handed assistive device that requires the use of the other upper extremity; or 3. An inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete work-related activities involving fine and gross movements. In developing this uniform and specific severity criteria, we utilized medical resources, such as ‘‘Ambulatory Assistive Devices in Orthopaedics: Uses and Modifications,’’ 5 the professional experience of our medical consultants, information related to workplace functioning from the Bureau of Labor Statistics, and our adjudicative experience. Each of these criteria illustrate restrictions of multiple extremities and thus, significant limitations. We propose to explain each proposed listing in separate sections of the introduction. The following chart shows the headings of the current and proposed sections of the adult introductory text: Current introductory text Proposed introductory text A. Disorders of the musculoskeletal system ............................................ B. Loss of function .................................................................................... C. Diagnosis and Evaluation .................................................................... A. Which disorders do we evaluate under these listings? B. Which related disorders do we evaluate under other listings? C. What evidence do we need to evaluate your musculoskeletal disorder under these listings? D. How do we consider symptoms, including pain, under these listings? E. How do we use the functional criteria under these listings? F. What do we consider when we evaluate disorders of the skeletal spine resulting in compromise of a nerve root(s) (1.15)? G. What do we consider when we evaluate lumbar spinal stenosis resulting in compromise of the cauda equina (1.16)? H. What do we consider when we evaluate reconstructive surgery or surgical arthrodesis of a major weight-bearing joint (1.17)? I. What do we consider when we evaluate abnormality of a major joint(s) in any extremity (1.18)? J. What do we consider when we evaluate pathologic fractures due to any cause (1.19)? K. What do we consider when we evaluate amputation due to any cause (1.20)? L. What do we consider when we evaluate soft tissue injury or abnormality under continuing surgical management (1.21)? M. What do we consider when we evaluate non-healing or complex fractures of the femur, tibia, pelvis, or one or more of the tarsal bones (1.22)? N. What do we consider when we evaluate non-healing or complex fractures of an upper extremity (1.23)? D. The physical examination .................................................................... E. Examination of the Spine ..................................................................... F. Major joints ........................................................................................... G. Measurements of joint motion ............................................................. H. Documentation ..................................................................................... I. Effects of Treatment .............................................................................. J. Orthotic, Prosthetic, or Assistive Devices ............................................ K. Disorders of the spine .......................................................................... daltland on DSKBBV9HB2PROD with PROPOSALS3 L. Abnormal curvatures of the spine ........................................................ M. Under continuing surgical management ............................................. N. After maximum benefit from therapy has been achieved ................... 5 Full citation is available in X. References, below. VerDate Sep<11>2014 21:10 May 04, 2018 Jkt 244001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 E:\FR\FM\07MYP3.SGM 07MYP3 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules 20649 Current introductory text Proposed introductory text O. Major function of the face and head ................................................... O. How do we determine when your soft tissue injury or abnormality, or your upper extremity fracture, is no longer under continuing surgical management or you have received maximum therapeutic benefit? P. How do we evaluate the severity and duration of your established musculoskeletal disorder when there is no record of ongoing treatment? Q. How do we evaluate substance use disorders that co-exist with musculoskeletal disorders? R. How do we evaluate disorders that do not meet one of the musculoskeletal listings? P. When surgical procedures have been performed ............................... Q. Effects of obesity ................................................................................. Proposed 1.00—Introduction The following is a detailed description of the changes we propose to the introductory text. Proposed 1.00A—Which disorders do we evaluate under these listings? We propose to revise current 1.00A Disorders of the musculoskeletal system to explain that we evaluate musculoskeletal disorders that result in dysfunction of the skeletal spine or of the upper or lower extremities,6 fractures, and soft tissue 7 abnormalities or injuries that are under continuing surgical management. We begin with listings for disorders affecting functioning of the skeletal spine, because our adjudicative experience shows that these are the most frequently used listings in this body system. daltland on DSKBBV9HB2PROD with PROPOSALS3 Proposed 1.00B—Which related disorders do we evaluate under other listings? We propose to replace the content of current 1.00B Loss of function with improved guidance for disorders that affect musculoskeletal functioning, which we evaluate under other listings. We explain that we evaluate injuries of the skeletal spine resulting in dysfunction of the spinal cord under 11.00 Neurological Disorders, and we evaluate inflammatory arthritis under 14.00 Immune System Disorders. We state that we evaluate abnormal curvatures of the spine that adversely affect functioning in other body systems under the appropriate listing in the affected body system. We have removed the guidance from current 1.00L that states ‘‘Abnormal curvatures of the spine (specifically, scoliosis, kyphosis and kyphoscoliosis) can result in 6 Impairments involving the shoulders will typically affect upper extremities while the impairments involving the pelvis, hips, and ribs typically affect lower extremities. When assessing dysfunction, the resultant incapacity or limitation is key to assessing the impairment under the applicable medical listing. 7 Soft tissue refers to non-skeletal tissues that make up a large percentage of the body, such as the tendons, ligaments, fascia and muscles. VerDate Sep<11>2014 21:10 May 04, 2018 Jkt 244001 impaired ambulation, but may also adversely affect functioning in body systems other than the musculoskeletal system.’’ Instead, we propose to evaluate spinal curvatures that affect musculoskeletal functioning under proposed 1.15 Disorders of the skeletal spine resulting in compromise of a nerve root(s), depending on the area of dysfunction created by the curvature. We also state that we can evaluate a curvature of the spine that is under continuing surgical management under proposed 1.21 Soft tissue injury or abnormality under continuing surgical management. Proposed 1.00C—What evidence do we need to evaluate your musculoskeletal disorder under these listings? We propose to replace current 1.00C Diagnosis and Evaluation with a comprehensive explanation of the information and evidence we need to evaluate musculoskeletal disorders. Once we establish the disorder, we evaluate evidence from medical and non-medical sources to assess severity and duration under the musculoskeletal listings. We describe the elements needed in a physical examination report. We discuss laboratory and other test findings and their usefulness and limitations, and we explain our policy concerning evaluation of imaging and other diagnostic tests. We discuss our need for operative reports and what we will accept in the absence of such reports, incorporating the guidance from current introductory section 1.00P When surgical procedures have been performed. We identify the evidence we need concerning a person’s treatment and response to it. In section 1.00C6 Assistive devices, we clarify what we mean by a prosthesis(es) and an orthosis(es). We discuss the evidence we need when a person with a musculoskeletal disorder uses an assistive device(s), including a cane(s), crutch(es), walker, prosthesis(es), or orthosis(es). In section 1.00C7 Longitudinal evidence, we explain the importance of a longitudinal medical record in PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 determining whether a musculoskeletal disorder satisfies the duration requirement. We explain that, for all listings except 1.19 Pathologic fractures due to any cause, 1.20A ‘‘Amputation of both upper extremities’’ 1.20B ‘‘Hemipelvectomy or hip disarticulation’’, and 1.21 Soft tissue injury or abnormality under continuing surgical management, all listing criteria must be present simultaneously, or within a close proximity of time; and must have lasted, or be expected to last, for a continuous period of at least 12 months for a disorder to meet a listing. In section 1.00C What evidence do we need to evaluate your musculoskeletal disorder under these listings?, we clarify that, when the listing criteria are linked by the word ‘‘and’’ (whether in small case or capital case), the requirements must be simultaneously present, or present within a ‘‘close proximity of time,’’ which we define in section 1.00C7 as meaning that all of the relevant criteria have to appear in the medical record within a period not to exceed 4 months of one another. Consistent with the standard of care and common industry practice, according to our medical consultants, literature review, and external medical experts, such as those from the Health and Medicine Division at the National Academies of Science Engineering and Medicine, an individual receiving treatment for a chronic severe musculoskeletal impairment will typically receive treatment or undergo examination at least once every 3 months. Should an individual meet an applicable listing, the listing criteria is likely to be documented every third month. The 4-month threshold provides leeway in cases where a physical examination might not be performed or symptoms are not documented at a given appointment. The 4-month threshold represents a period in which individuals receiving treatment for a chronic severe musculoskeletal impairment will undergo multiple examinations or treatments from their medical source(s), providing a window encompassing multiple medical E:\FR\FM\07MYP3.SGM 07MYP3 20650 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules daltland on DSKBBV9HB2PROD with PROPOSALS3 appointments over which applicable listing criteria can be adequately documented. The 4-month threshold does not apply to imaging. We propose to add this clarification to address a holding in Radford v. Colvin, 734 F.3d 288 (4th Cir. 2013) with respect to current 1.04A Disorders of the spine, ‘‘Evidence of nerve root compression.’’ The Radford Court held that ‘‘[a] claimant need not show that each symptom was present at precisely the same time—i.e., simultaneously—in order to establish the chronic nature of his condition. Nor need a claimant show that the symptoms were present in the claimant in particularly close proximity.’’ 8 Because this holding of the Radford Court differed from our interpretation of the listing requirement, we issued Acquiescence Ruling (AR) 15–1(4) to implement the Court of Appeals holding within the States in the Fourth Circuit.9 We now propose to clarify our longstanding interpretation of the regulations in response to the Radford decision. We also propose to clarify that this policy applies to other listings that have similar requirements. The issuance of a new regulation to address a holding of a Court of Appeals that conflicts with our policy is consistent with the process described in our regulations for issuing and rescinding Acquiescence Rulings. Our regulations specifically contemplate that we may ‘‘subsequently publish a new regulation(s) addressing an issue(s) not previously included in our regulations when that issue(s) was the subject of a circuit court holding that conflicted with our interpretation of the Social Security Act or regulations and that holding was not compelled by the statute or Constitution.’’ 20 CFR 404.985(e)(4), 416.1485(e)(4). After we have considered the public comments in response to these proposed rules and issued any final rules, we will decide whether we need to rescind the Radford AR. Section 1.00C8 Surgical treatment, discusses how we evaluate surgical treatment. We explain when and why we may wait to receive additional evidence before making a determination of disability. Proposed 1.00D—How do we consider symptoms, including pain, under these listings? We propose to replace current 1.00D The physical examination with 8 734 F.3d at 294. FR 57418 (2015). Available at: https:// www.ssa.gov/OP_Home/rulings/ar/04/AR2015-01ar-04.html. 9 80 VerDate Sep<11>2014 21:10 May 04, 2018 Jkt 244001 guidance about how we consider symptoms of musculoskeletal impairments, particularly pain. We explain that your pain must be supported by medical signs and laboratory findings, established by medically acceptable clinical, laboratory, or diagnostic techniques, showing the existence of a medical impairment(s) which results from anatomical, physiological, or psychological abnormalities. Proposed 1.00E—How do we use the functional criteria under these listings? We propose to replace current 1.00E Examination of the Spine with new guidance about how we use the functional criteria to evaluate musculoskeletal disorders under these listings. We explain what we mean by functional criteria, we list the criteria, and we explain why listings 1.20A ‘Amputation of both upper extremities’’, 1.20B ‘‘Hemipelvectomy or hip disarticulation’’ and 1.21 Soft tissue injury or abnormality under continuing surgical management do not include the functional criteria. We also explain that we will evaluate a person’s functioning with respect to the work environment, rather than the home environment, because the ability to walk independently about one’s home without the use of assistive devices does not, in and of itself, indicate an ability to walk without an assistive device in a work environment. We explain that in order to be disabling, a musculoskeletal disorder must satisfy the medical criteria as well as the 12-month duration requirement and, where applicable, must include at least one of the functional criteria of a listing. Proposed 1.00F—What do we consider when we evaluate disorders of the skeletal spine resulting in compromise of a nerve root(s) (1.15)? We propose to replace the content of current 1.00F Major joints with guidance regarding how we evaluate disorders of the skeletal spine under proposed 1.15 Disorders of the skeletal spine resulting in compromise of a nerve root(s). In proposed 1.00F, we list the various spinal disorders that result in compromise of nerve roots; we explain the symptoms and signs associated with those disorders; and we explain how a medical source evaluates those symptoms and signs in clinical examinations. PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 Proposed 1.00G—What do we consider when we evaluate lumbar spinal stenosis resulting in compromise of the cauda equina (1.16)? We propose to replace the content of current 1.00G Measurements of joint motion with guidance about how we evaluate the effects of compromise of the cauda equina due to lumbar spinal stenosis under proposed 1.16 Lumbar spinal stenosis resulting in compromise of the cauda equina. We explain how lumbar spinal stenosis can compromise the cauda equina; we provide a more detailed discussion of the cauda equina and associated symptoms and signs; and we explain how the disorder affects functioning. We also explain the difference between pain caused by compromise of the cauda equina (neurogenic claudication or pseudoclaudication) and pain caused by peripheral arterial disease (vascular claudication). Proposed 1.00I—What do we consider when we evaluate abnormality of a major joint(s) in any extremity (1.18)? We propose to replace the content of current 1.00I Effects of Treatment with guidance about how we evaluate abnormality in a major joint(s) under proposed 1.18 Abnormality of a major joint(s) in any extremity. We explain how we define abnormalities of the joints, and give specific examples of the types of diseases, injuries, and other conditions that may contribute to joint dysfunction. We also explain how these disorders interfere with functions of the extremities. Proposed 1.00J—What do we consider when we evaluate pathologic fractures due to any cause (1.19)? We propose to replace the content of current 1.00J Orthotic, Prosthetic, or Assistive Devices with guidance regarding how we evaluate pathologic fractures under proposed new 1.19 Pathologic fractures due to any cause. We explain what we mean by ‘‘pathologic fractures;’’ we state that these types of fractures can affect the skeletal spine, extremities, or other parts of the skeletal system; we give examples of disorders that can cause pathologic fractures; and we explain how we evaluate their occurrence and recurrence. Proposed 1.00K—What do we consider when we evaluate amputation due to any cause (1.20)? We propose to replace the content of current 1.00K Disorders of the spine with guidance about how we evaluate amputation due to any cause under proposed 1.20 Amputation due to any E:\FR\FM\07MYP3.SGM 07MYP3 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules daltland on DSKBBV9HB2PROD with PROPOSALS3 cause. We explain that we evaluate amputations involving upper or lower extremities and combinations of those extremities, as well as hemipelvectomies and hip disarticulations. We explain that when a person has amputations of one upper extremity at any level above the wrist and one lower extremity at or above the ankle, we consider whether the person has a documented medical need for a one-handed assistive device. We also explain how we consider amputation of one or both lower extremities at or above the ankle (tarsal joint). We state that we use this listing when a person has residual limb complications that have lasted, or are expected to last, for at least 12 months, and the person is not currently undergoing surgical management. Proposed 1.00L—What do we consider when we evaluate soft tissue injury or abnormality under continuing surgical management (1.21)? We propose to replace the content of current 1.00L Abnormal curvatures of the spine with guidance about how we evaluate soft tissue abnormality or injury of any part of the body that is under continuing surgical management. We also incorporate the provisions of current sections 1.00M Under continuing surgical management, 1.00N After maximum benefit from therapy has been achieved, 1.00O Major function of the face and head, and 1.00P When surgical procedures have been performed. We explain that we use proposed 1.21 Soft tissue injury or abnormality under continuing surgical management to evaluate any soft tissue abnormality or injury, whether congenital or acquired, including malformations, third- and fourth-degree burns, craniofacial injuries, avulsive injuries, amputations with complications of the residual limb(s), and complications of non-healing or complex traumatic fractures. We explain that a person must have a documented medical need for a continuing series of ongoing surgical procedures and associated medical treatments, directed toward saving, reconstructing, or replacing the affected part of the body. We further explain that these treatments must have been, or must be expected to be, ongoing for a continuous period of least 12 months. We list the clinical evidence we need to determine whether a disorder meets this listing. We explain how we evaluate third- and fourth- VerDate Sep<11>2014 21:10 May 04, 2018 Jkt 244001 degree burns and craniofacial injuries. We also explain how we evaluate when maximum therapeutic benefit has occurred and how we evaluate residual impairment. Proposed 1.00M—What do we consider when we evaluate non-healing or complex fractures of the femur, tibia, pelvis, or one or more of the tarsal bones (1.22)? We propose to replace the content of current 1.00M Under continuing surgical management with guidance about how we evaluate non-healing or complex fractures involving bones in the lower extremity. We also provide definitions for ‘‘non-healing fracture’’ and ‘‘complex fracture.’’ Proposed 1.00N—What do we consider when we evaluate non-healing or complex fractures of an upper extremity (1.23)? We propose to replace the content of current 1.00N After maximum benefit from therapy with guidance about how we evaluate non-healing or complex fractures involving bone in the upper extremity. We also provide definitions for ‘‘non-healing fracture’’ and ‘‘complex fracture.’’ Proposed 1.00O—How do we determine your soft tissue injury or abnormality or your upper extremity fracture is no longer under continuing surgical management or you have received maximum therapeutic benefit? We propose to replace the content of current 1.00O Major function of the face and head with guidance about determining when a soft tissue injury or abnormality or upper extremity fracture is no longer under continuing surgical management. We also incorporate the provisions of current sections 1.00M Under continuing surgical management, 1.00N After maximum benefit from therapy has been achieved, and 1.00P When surgical procedures have been performed. Proposed 1.00P—How do we evaluate the severity and duration of your established musculoskeletal disorder when there is no record of ongoing treatment? We propose to replace the content of current 1.00P When surgical procedures have been performed with guidance about how we assess impairments when there is no longitudinal medical record. We explain that when the individual PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 20651 has not received ongoing treatment or has just begun treatment, we may ask the individual to attend a consultative examination. We also explain that we may be able to assess the severity and duration of the individual’s impairment based on the medical record and current evidence alone. In this section, we incorporate guidance from current section 1.00H3 When there is no record of ongoing treatment. Proposed 1.00R—How do we evaluate disorders that do not meet one of the musculoskeletal listings? We propose to add a new section 1.00R with guidance explaining that if a person’s disorder does not meet or medically equal the criteria of any of these listings, we will consider whether it meets or medically equals the criteria for a listing in another body system. We explain that if an impairment does not meet or medically equal any listing, we will assess the person’s residual functional capacity (RFC) and determine whether the person is capable of performing past work or adjusting to other work in the national economy. We also cite the rules we use when we determine whether a person continues to be disabled. In this section, we incorporate guidance from current section 1.00H4 Evaluation when the criteria of a musculoskeletal listing are not met. V. What changes are we proposing to the musculoskeletal listings for adults? We propose to revise the name of the body system from ‘‘Musculoskeletal System’’ to ‘‘Musculoskeletal Disorders.’’ We propose to rename the headings of the listings and to renumber the listings in a more logical order, beginning with disorders of the spine, as those are the most frequently used; moving outward physically to the extremities; and then to skeletal or soft tissue injuries. When these rules become final, renumbering the listings should make it easier for us to keep track of data trends for specific types of impairments over time. It should also help to prevent confusion in identifying or referring to prior listings after we publish a final rule. We propose to present the overall structure of the listings in an outline form to make the rules more readily accessible to the reader. The following chart provides a comparison of the current and the proposed adult listings: E:\FR\FM\07MYP3.SGM 07MYP3 20652 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules Current listing Proposed listing 1.02 Major dysfunction of a joint(s) (due to any cause) ........................ 1.03 Reconstructive surgery or surgical arthrodesis of a major weightbearing joint. 1.04 Disorders of the spine .................................................................... 1.05 Amputation (due to any cause) ..................................................... 1.06 Fracture of the femur, tibia, pelvis, or one or more of the tarsal bones. 1.07 Fracture of an upper extremity ...................................................... 1.08 Soft tissue injury (e.g., burns) ........................................................ All of the proposed musculoskeletal listings contain multiple criteria. We distinguish whether all of the criteria must be met in order to meet that specific listing or just one of the criteria must be met in order to meet that specific listing by using a capital ‘‘AND’’ or ‘‘OR,’’ respectively. The ‘‘AND’’ or ‘‘OR’’ sit on a line independently on the left margin. We also distinguish whether all sub-criteria must be met or just one of the subcriteria must be met in order to satisfy the relevant criteria by using a lowercase ‘‘and’’ or ‘‘or,’’ respectively. daltland on DSKBBV9HB2PROD with PROPOSALS3 1.15 Disorders of the Skeletal Spine Resulting in Compromise of a Nerve Root(s) 21:10 May 04, 2018 Jkt 244001 1.04 Removed without replacement. 1.05 Removed without replacement. 1.06 Removed without replacement. 1.07 Removed without replacement. 1.08 Removed without replacement. 1.15 Disorders of the skeletal spine resulting in compromise of a nerve root(s). 1.16 Lumbar spinal stenosis resulting in compromise of the cauda equina. 1.17 Reconstructive surgery or surgical arthrodesis of a major weightbearing joint. 1.18 Abnormality of a major joint(s) in any extremity. 1.19 Pathologic fractures due to any cause. 1.20 Amputation due to any cause. 1.21 Soft tissue injury or abnormality under continuing surgical management. 1.22 Non-healing or complex fracture of the femur, tibia, pelvis, or one or more of the tarsal bones 1.23 Non-healing or complex fracture of an upper extremity. using the new functional criteria. Under proposed criterion 1.15B for radicular neurological signs, we have included muscle weakness and sensory changes. We have also added the requirement for ‘‘[d]ecreased deep tendon reflexes’’ to the criterion because it is a manifestation of the disorder and illustrates our intentions for this listing. A criterion for imaging, which is not explicitly required in current 1.04A, has been added as proposed 1.15C ‘‘Findings on imaging consistent with compromise of a nerve root(s)’’ because it is a component necessary to establishing the disorder. 1.16 Lumbar Spinal Stenosis Resulting in Compromise of the Cauda Equina Proposed 1.15 Disorders of the skeletal spine resulting in compromise of a nerve root(s) incorporates and clarifies the provisions of current 1.04A for evidence of nerve root compression. In proposed 1.15 we have removed references to the particular disorders associated with compromise of a nerve root(s) and discussion of the tests used to demonstrate them. We have incorporated the references to specific disorders in the introductory text because they are examples of possible causative agents, whereas the listing addresses the effects of those agents on the nerve root(s). We have also removed the sign of atrophy from the listing because medical research and our experience does not show atrophy necessarily correlates with any given level of functioning. We have provided for consideration of limitation of motion by evaluating the physical limitation of musculoskeletal functioning it causes VerDate Sep<11>2014 1.02 Removed without replacement. 1.03 Removed without replacement. Proposed 1.16 Lumbar spinal stenosis resulting in compromise of the cauda equina incorporates and clarifies the provisions of current 1.04C for lumbar spinal stenosis resulting in pseudoclaudication. We incorporate each of the requirements in current 1.04C into sections A–D of the proposed listing and clarify the current requirements with specific information in sections A–C. We have made a separate listing for compromise of the cauda equina due to the effects of lumbar spinal stenosis, because the symptoms and signs of this disorder differ from those of other nerve root(s) disorders and are not typically associated with a specific nerve root(s). 1.17 Reconstructive Surgery or Surgical Arthrodesis of a Major WeightBearing Joint Proposed 1.17 Reconstructive surgery or surgical arthrodesis of a PO 00000 Frm 00008 Fmt 4701 Sfmt 4702 major weight-bearing joint incorporates and clarifies the provisions of current listing 1.03 Reconstructive surgery or surgical arthrodesis of a major weightbearing joint. 1.18 Abnormality of a Major Joint(s) in Any Extremity Proposed 1.18 Abnormality of a major joint(s) in any extremity incorporates and clarifies the provisions of current listings 1.02 Major dysfunction of a joint(s) (due to any cause). It includes the criteria from current 1.02 for evaluating dysfunction of any of the major joints in either the upper or lower extremities, or both, whether due to anatomical deformity, pain, or abnormal motion. We removed the terms ‘‘peripheral’’ and ‘‘weightbearing,’’ which are in the current listing for major joint disorders (1.02 Major dysfunction of a joint(s) (due to any cause)), because proposed 1.18 covers all major joints in any extremity, making those distinctions unnecessary. 1.19 Pathologic Fractures Due to Any Cause Proposed 1.19 Pathologic fractures due to any cause is a new listing that covers pathologic fractures of any part of the musculoskeletal system. Medical treatment and recovery expectations for fractures differ, depending on whether the condition is due to an underlying pathology (such as osteoporosis), or to a traumatic event. For this reason, we propose a separate listing for fractures caused by an underlying pathology in order to provide specific criteria related to their evaluation and adjudication. We propose to evaluate complex or non- E:\FR\FM\07MYP3.SGM 07MYP3 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules healing traumatic fractures under proposed 1.22 Non-healing or complex fracture of the femur, tibia, pelvis, or one or more of the tarsal bones or 1.23 Non-healing or complex fracture of an upper extremity. 1.20 Amputation Due to Any Cause Proposed 1.20 Amputation due to any cause incorporates and clarifies the provisions of current 1.05 Amputation (due to any cause). Proposed 1.20B for hemipelvectomy or hip disarticulation corresponds to current 1.05D for hemipelvectomy or hip disarticulation. In proposed 1.20A for amputation of both upper extremities and 1.20B for hemipelvectomy or hip disarticulation, we do not include any functional criteria, because we presume that a person with a disorder under either proposed 1.20A or 1.20B has limitations that satisfy one or more of the functional criteria in 1.00E2 and meet the duration requirement. 1.21 Soft Tissue Injury or Abnormality Under Continuing Surgical Management Proposed 1.21 Soft tissue injury or abnormality under continuing surgical management revises current listing 1.08 Soft tissue injury (e.g., burns). This proposed listing is consistent with our long-standing recognition that extensive, prolonged treatment in order to re-establish or improve function of the affected body part(s) may contribute to an inability to perform work-related activity. It encompasses any abnormality of, or injury (including burns) to soft tissue that is under continuing surgical management directed toward saving, reconstructing, or replacing the affected part of the body. In proposed 1.21, we do not include any functional criteria because the prescribed surgical procedures treatments typically require a series of documented interventions over extended periods, which render the person unable to perform work-related activity on a sustained basis. 1.22 Non-Healing or Complex Fracture of the Femur, Tibia, Pelvis, or One or More of the Tarsal Bones Proposed 1.22 Non-healing or complex fracture of the femur, tibia, pelvis, or one or more of the tarsal bones incorporates and clarifies the provisions of current listing 1.06 Fracture of the femur, tibia, pelvis, or one or more of the tarsal bones. 20653 1.23 Non-Healing or Complex Fracture of an Upper Extremity Proposed 1.23 Non-healing or complex fracture of an upper extremity incorporates and clarifies the provisions of current listing 1.07 Fracture of an upper extremity. VI. What changes are we proposing to the introductory text of the musculoskeletal disorders listings for children? The same basic rules for evaluating musculoskeletal disorders in adults apply to the evaluation of such disorders in children. Except for changes in the introductory text specific to children, we propose to repeat most of the introductory text of proposed 1.00 Musculoskeletal Disorders in the introductory text of proposed 101.00 Musculoskeletal Disorders. Since we have already described these proposed revisions in the introductory text of proposed 1.00, we describe here only those sections of the proposed 101.00 rules that are unique to children or that require further explanation. The following chart shows the headings of the current and proposed sections of the childhood introductory text: Current introductory text Proposed introductory text A. Disorders of the musculoskeletal system ............................................ B. Loss of Function .................................................................................. C. Diagnosis and Evaluation .................................................................... A. Which disorders do we evaluate under these listings? B. Which related disorders do we evaluate under other listings? C. What evidence do we need to evaluate your musculoskeletal disorder under these listings? D. How do we consider symptoms, including pain, under these listings? E. How do we use the functional criteria under these listings? F. What do we consider when we evaluate disorders of the skeletal spine resulting in compromise of a nerve root(s) (101.15)? G. What do we consider when we evaluate lumbar spinal stenosis resulting in compromise of the cauda equina (101.16)? H. What do we consider when we evaluate reconstructive surgery or surgical arthrodesis of a major weight-bearing joint (101.17)? I. What do we consider when we evaluate abnormality of a major joint(s) in any extremity (101.18)? J.What do we consider when we evaluate pathologic fractures due to any cause (101.19)? K. What do we consider when we evaluate amputation due to any cause (101.20)? L. What do we consider when we evaluate soft tissue injury or abnormality under continuing surgical management (101.21)? M. What do we consider when we evaluate non-healing or complex fractures of the femur, tibia, pelvis, or one or more of the tarsal bones (101.22)? N. What do we consider when we evaluate non-healing or complex fractures of an upper extremity (101.23)? O. What do we consider when we evaluate musculoskeletal disorders of infants and toddlers from birth to attainment of age 3 with developmental motor delay (101.24)? P. How do we determine when your soft tissue injury or abnormality, or your upper extremity fracture, is no longer under continuing surgical management or you have received maximum therapeutic benefit? Q. How do we evaluate the severity and duration of your established musculoskeletal disorder when there is no record of ongoing treatment? R. How do we evaluate disorders that do not meet one of the musculoskeletal listings? D. The physical examination .................................................................... E. Examination of the Spine ..................................................................... F. Major joints ........................................................................................... G. Measurements of joint motion ............................................................. H. Documentation ..................................................................................... I. Effects of Treatment .............................................................................. J. Orthotic, Prosthetic, or Assistive Devices ............................................ K. Disorders of the spine .......................................................................... L. Abnormal curvatures of the spine ........................................................ M. Under continuing surgical management ............................................. N. After maximum benefit from therapy has been achieved ................... daltland on DSKBBV9HB2PROD with PROPOSALS3 O. Major function of the face and head ................................................... P. When surgical procedures have been performed ............................... VerDate Sep<11>2014 21:10 May 04, 2018 Jkt 244001 PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 E:\FR\FM\07MYP3.SGM 07MYP3 20654 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules 3, with developmental motor delay. This listing evaluates developmental motor delay due to a musculoskeletal medically determinable impairment as a We propose to revise the name of the functional criterion for infants and body system from ‘‘Musculoskeletal toddlers. We propose to move the System’’ to ‘‘Musculoskeletal requirement of developmental motor Disorders.’’ skills that are no greater than one-half We propose to add 101.24 of the expected age performance from Musculoskeletal disorders of infants and current 101.00B2c(2) How we assess toddlers, from birth to attainment of age inability to perform fine and gross VII. What changes are we proposing to the musculoskeletal disorders listings for children? Current childhood listings Proposed childhood listings 101.02 Major dysfunction of a joint(s) (due to any cause) .................... 101.03 Reconstructive surgery or surgical arthrodesis of a major weight-bearing joint. 101.04 Disorders of the spine ................................................................ 101.05 Amputation (due to any cause) ................................................. 101.06 Fracture of the femur, tibia, pelvis, or one or more of the tarsal bones. 101.07 Fracture of an upper extremity .................................................. 101.08 Soft tissue injury (e.g., burns) .................................................... As is the case with adults, for children, all of the proposed musculoskeletal listings contain multiple criteria. We distinguish whether all of the criteria must be met in order to meet that specific listing or just one of the criteria must be met in order to meet that specific listing by using a capital ‘‘AND’’ or ‘‘OR,’’ respectively. The ‘‘AND’’ or ‘‘OR’’ sit on a line independently on the left margin. We also distinguish whether all subcriteria must be met or just one of the sub-criteria must be met in order to satisfy the relevant criteria by using a lowercase ‘‘and’’ or ‘‘or,’’ respectively. daltland on DSKBBV9HB2PROD with PROPOSALS3 VIII. Other Changes We propose to make conforming changes to current sections 4.00G4 What is lymphedema and how will we evaluate it? and 104.00F9 What is lymphedema and how will we evaluate it? of the cardiovascular system listings to indicate that we may evaluate whether lymphedema medically equals proposed listings 1.18 and 101.18 Abnormality of a major joint(s) in any extremity. VerDate Sep<11>2014 21:10 May 04, 2018 Jkt 244001 movements in very young children into proposed 101.24. Proposed 101.24 does not have an adult counterpart. We propose to use functional criteria for children that are the same as the criteria for adults. The following chart provides a comparison of the current childhood listings and the proposed childhood listings: 101.02 Removed without replacement. 101.03 Removed without replacement. 101.04 Removed without replacement. 101.05 Removed without replacement. 101.06 Removed without replacement. 101.07 Removed without replacement. 101.08 Removed without replacement. 101.15 Disorders of the skeletal spine resulting in compromise of a nerve root(s). 101.16 Lumbar spinal stenosis resulting in compromise of the cauda equina. 101.17 Reconstructive surgery or surgical arthrodesis of a major weight-bearing joint. 101.18 Abnormality of a major joint(s) in any extremity. 101.19 Pathologic fractures due to any cause. 101.20 Amputation due to any cause. 101.21 Soft tissue injury or abnormality under continuing surgical management. 101.22 Non-healing or complex fracture of the femur, tibia, pelvis, or one or more of the tarsal bones. 101.23 Non-healing or complex fracture of an upper extremity. 101.24 Musculoskeletal disorders of infants and toddlers, from birth to attainment of age 3, with developmental motor delay. We propose to make conforming changes to the introductory text and listing criteria for immune system disorders. Many disorders of the immune system affect the musculoskeletal system; therefore, we are making these revisions to reflect this relationship and ensure consistency in our evaluation of musculoskeletal functioning. In 14.00C Definitions and 114.00C Definitions, we propose to provide explanations of terms for evaluating immune system disorders consistent with those we propose for evaluating musculoskeletal disorders. We propose to add definitions for ‘‘assistive device(s),’’ ‘‘documented medical need,’’ ‘‘fine and gross movements,’’ and ‘‘hand-held assistive device.’’ We also propose to replace ‘‘major peripheral joints’’ with ‘‘major joint of an upper or lower extremity,’’ to revise the explanation of that term, and to remove the terms ‘‘inability to ambulate effectively’’ and ‘‘inability to perform fine and gross movements effectively’’ for consistency with the proposed musculoskeletal disorders listings. PO 00000 Frm 00010 Fmt 4701 Sfmt 4702 We propose to revise the information in current sections 14.00D4 Polymyositis and dermatomyositis (14.05) and 114.00D4 ‘‘Polymyositis and dermatomyositis (114.05)’’ describing how we evaluate polymyositis and dermatomyositis in motor skills of newborns, younger infants, children, and adults. We propose to revise these sections for consistency with the proposal to remove the term ‘‘unable to ambulate effectively.’’ We propose to replace ‘‘ambulate effectively’’ with ‘‘walk without physical or mechanical assistance.’’ We propose to make editorial changes to current sections 14.00D6 Inflammatory arthritis (14.09) and 114.00D6 Inflammatory arthritis (114.09). We propose to replace ‘‘major peripheral joints’’ with ‘‘major joints in an upper or lower extremity,’’ ‘‘ambulation or fine and gross movements’’ with ‘‘walking or performing fine and gross movements,’’ and ‘‘ambulation or the performance of fine and gross movements’’ with ‘‘walking or performing fine and gross movements.’’ E:\FR\FM\07MYP3.SGM 07MYP3 daltland on DSKBBV9HB2PROD with PROPOSALS3 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules We propose to make conforming changes to describe listing-level severity in proposed listing criteria 14.09A and 114.09A ‘‘Persistent inflammation or persistent deformity’’ as follows: we propose to replace ‘‘an impairment that results in an ‘extreme’ (very serious) limitation’’ with ‘‘the presence of an impairment-related, significant limitation cited in the criteria of these listings.’’ We propose to replace ‘‘one major peripheral weight-bearing joint resulting in the inability to ambulate effectively’’ with ‘‘one major joint in a lower extremity resulting in a documented medical need for a walker, bilateral canes, or bilateral crutches.’’ We propose to replace ‘‘one major peripheral joint in each upper extremity resulting in the inability to perform fine and gross movements effectively’’ with ‘‘one major joint in each upper extremity resulting in an impairmentrelated, significant limitation in the ability to perform fine and gross movements.’’ To describe listing-level severity in current listing criteria 14.09C and 114.09 C ‘‘Ankylosing spondylitis or other spondyloarthropathies’’ we propose to replace ‘‘extreme limitation’’ with ‘‘impairment-related significant limitation’’ and ‘‘inability to ambulate effectively’’ with ‘‘a documented medical need for a walker, bilateral canes, or bilateral crutches.’’ To describe listing-level severity in current listing criteria 14.09B, C, and D and 114.09B and C for impairments due to inflammatory arthritis, we also propose to replace ‘‘major peripheral joints’’ with ‘‘major joints in an upper or lower extremity.’’ We propose to revise current section 114.00J2b ‘‘Musculoskeletal involvement, such as surgical reconstruction of a joint, under 101.00’’ to indicate that we may evaluate immune system disorders in children involving developmental motor delay under 101.00 Musculoskeletal Disorders. We propose conforming changes to current immune system disorders listings 14.04 Systemic sclerosis (scleroderma), 14.05 Polymyositis and dermatomyositis, 14.09 Inflammatory arthritis, 114.04 Systemic sclerosis (scleroderma), 114.05 Polymyositis and dermatomyositis and 114.09 Inflammatory arthritis. In proposed 14.04 Systemic sclerosis (scleroderma), 14.05 Polymyositis and dermatomyositis, and 14.09 Inflammatory arthritis for adults, we would replace ‘‘inability to ambulate effectively’’ with the requirement of one of the following: VerDate Sep<11>2014 21:10 May 04, 2018 Jkt 244001 • A documented medical need for a walker, bilateral canes, or bilateral crutches; or • An inability to use one upper extremity to independently initiate, sustain, and complete work-related activities involving fine and gross movements, and a documented medical need for a one-handed assistive device that requires the use of the other upper extremity. In proposed 114.04 Systemic sclerosis (scleroderma), 114.05 Polymyositis and dermatomyositis, and 114.09 Inflammatory arthritis for children, we would replace ‘‘inability to ambulate effectively’’ with the requirement of one of the following: • A documented medical need for a walker, bilateral canes, or bilateral crutches; or • An inability to use one upper extremity to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements, and a documented medical need for a one-handed assistive device that requires the use of the other upper extremity. In proposed 14.04 Systemic sclerosis (scleroderma), 14.05 Polymyositis and dermatomyositis, and 14.09 Inflammatory arthritis for adults, we would replace ‘‘inability to perform fine and gross movements effectively’’ with ‘‘inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete work-related activities involving fine and gross movements.’’ In proposed 114.04 Systemic sclerosis (scleroderma), 114.05 Polymyositis and dermatomyositis, and 114.09 Inflammatory arthritis for children, we would replace ‘‘inability to perform fine and gross movements effectively’’ with ‘‘inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements.’’ In proposed 14.09 Inflammatory arthritis and 114.09 Inflammatory arthritis, we would replace ‘‘major peripheral weight-bearing joints’’ with ‘‘major joints in a lower extremity(ies).’’ In proposed 14.09 Inflammatory arthritis and 114.09 Inflammatory arthritis, we would replace ‘‘major peripheral joints’’ with ‘‘major joints’’ or ‘‘major joints of an upper or lower extremity(ies),’’ as appropriate for the affected extremity(-ies). We propose to remove the first and second examples in § 416.926a(m) of this chapter, Examples of impairments that functionally equal the listings. The first example is ‘‘[a]ny condition that is disabling at the time of onset, requiring PO 00000 Frm 00011 Fmt 4701 Sfmt 4702 20655 continuing surgical management within 12 months after onset as a life-saving measure or for salvage or restoration of function, and such major function is not restored or is not expected to be restored within 12 months after onset of this condition.’’ (See § 416.926a(m)(1) of this chapter.) We are removing this example because, at the time it was written, there were no specific criteria that considered the need for ongoing surgical management in the listings. The second example is ‘‘[e]ffective ambulation possible only with obligatory bilateral upper limb assistance.’’ (See § 416.926a(m)(2) of this chapter.) We are removing this example because several of the proposed childhood listings include a criterion considering ‘‘. . . a documented medical need for a walker, bilateral canes, or bilateral crutches’’ (that is, ‘‘obligatory bilateral upper limb assistance.’’) With the inclusion of the proposed childhood listings, it will no longer be necessary to have these examples in the regulations. IX. Administrative Matters What is our authority to make rules and set procedures for determining whether a person is disabled under our statutory definition? The Social Security Act authorizes us to make rules and regulations and to establish necessary and appropriate procedures to implement them.10 How long would these proposed rules be effective? If we publish these proposed rules as final rules, they will remain in effect for 5 years after the date they become effective, unless we extend them, or revise and issue them again. Clarity of These Proposed Rules Executive Order 12866, as supplemented by Executive Order 13563, requires each agency to write all rules in plain language. In addition to your substantive comments on these proposed rules, we invite your comments on how to make them easier to understand. For example: • Would more, but shorter, sections be better? • Are the requirements in the rules clearly stated? • Have we organized the material to suit your needs? • Could we improve clarity by adding tables, lists, or diagrams? • What else could we do to make the rules easier to understand? • Do the rules contain technical language or jargon that is not clear? 10 Sections E:\FR\FM\07MYP3.SGM 205(a), 702(a)(5), and 1631(d)(1). 07MYP3 20656 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules • Would a different format make the rules easier to understand, e.g., grouping and order of sections, use of headings, paragraphing? Anticipated Economic Impact of the Proposed Rules Financial Classification of SSA’s Regulations Based on criteria established by OMB Circular A–4 and Executive Order 13771, we classify this rule as a ‘‘transfer rule.’’ Transfer rules do not create or impose novel costs; rather, they regulate the transfer of monetary payments from one group to another without affecting the total resources available to society. Under our Old-Age, Survivors, and Disability Insurance program (OASDI), SSA’s regulations govern the transfer of benefits payments to qualified workers primarily from revenues collected from payroll taxes (FICA) and selfemployment taxes (SECA). Under the Supplemental Security Income (SSI) program, funded by general tax revenues, SSA makes payments to individuals with limited income and resources who are aged, blind, or disabled. This proposed rule establishes eligibility criteria for transferring disability payments to those persons who qualify for such payments based on the presence of a musculoskeletal body system disorder. Anticipated Accounting Costs of These Proposed Rules daltland on DSKBBV9HB2PROD with PROPOSALS3 Anticipated Costs to Our Programs For fiscal years (FY) 2018–2022, our Office of the Chief Actuary estimates that this proposed rule, once finalized, may result in a reduction of $57,000,000 to our OASDI program costs, and an increase of $11,000,000 to our SSI program costs. It is important to note that due to the roughly offsetting estimated effects of changes from allowance to denial and from denial to allowance, the true net effect for either program, OASDI or SSI, could potentially be either a small cost or a small saving. Anticipated Administrative Costs to the Social Security Administration In calculating whether the implementation of this proposed rule, once finalized, may result in administrative costs or savings to the agency, we examine two sources: (1) Work-years and (2) direct financial administrative costs. We define work-years as a measure of the SSA employee work time a proposed rule will cost or save during VerDate Sep<11>2014 21:10 May 04, 2018 Jkt 244001 implementation of its policies. We calculate one work-year as 2,080 hours of labor, which represents the amount of hours one SSA employee works per year based on a standard 40-hour workweek. We estimate the direct financial administrative costs of a proposed rule by examining requirements stemming from new regulations, including systems start-up and maintenance costs, operational costs resulting from new workloads, and internal training costs for relevant agency staff and adjudicators. To assess savings resulting from a proposed rule, we examine Systems and operational workload changes. Based on the above factors, our Office of Budget, Finance, and Management estimates that implementation of these proposed rules, upon finalization, will result in overall administrative savings for SSA of fewer than 15 work-years and less than $2 million annually for the period of FY 2018–2022. When will we start to use these rules? We will not use these rules until we evaluate public comments and publish final rules in the Federal Register. All final rules we issue include an effective date. We will continue to use our current rules until that date. If we publish final rules, we will include a summary of those relevant comments we received along with responses and an explanation of how we will apply the new rules. Regulatory Procedures Executive Order 12866, as Supplemented by Executive Order 13563 We consulted with the Office of Management and Budget (OMB) and determined that this notice of proposed rulemaking (NPRM) meets the criteria for a significant regulatory action under Executive Order 12866, as supplemented by Executive Order 13563. Therefore, OMB reviewed it. Regulatory Flexibility Act We certify that this NPRM will not have a significant economic impact on a substantial number of small entities because it affects individuals only. Therefore, a regulatory flexibility analysis is not required under the Regulatory Flexibility Act, as amended. Paperwork Reduction Act These proposed rules do not create any new or affect any existing collections and, therefore, do not require OMB approval under the Paperwork Reduction Act. PO 00000 Frm 00012 Fmt 4701 Sfmt 4702 X. References We consulted the following references when we developed these proposed rules: Alentado, V.J., Caldwell, S., Gould, H.P., Steinmetz, M.P., Benzel, E.C., & Mroz, T.E. (2017). Independent predictors of a clinically significant improvement after lumbar fusion surgery. The Spine Journal, 17(2), 236–243. https://doi.org/ 10.1016/j.spinee.2016.09.011. Anatchkova, M.D., Saris-Baglama, R.N., Kozinski, M., & Bjorner, J.B. (2009). Development and preliminary testing of a computerized adaptive assessment of chronic pain. The Journal of Pain, 10(9), 932–943. https://doi.org/10.1016/ j.jpain.2009.03.007. Arosarena, O.A. (2007). Cleft lip and palate. Otolaryngologic Clinics of North America, 40(1), 27–60. https://doi.org/ 10.1016/j.otc.2006.10.011. Baber, Z. & Erdek M.A. (2016). Failed back surgery syndrome: Current perspectives. Journal of Pain Research, 9, 979–987. https://doi.org/10.2147/JPR.S92776. Bateni, H. & Maki, B.E. (2005). 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Hand Clinics, 29(4), 579–584. https://doi.org/10.1016/j.hcl.2013.08.010. Hadler, N.M. (2005). Occupational Musculoskeletal Disorders (3rd ed.). Philadelphia, PA: Lippincott, Williams & Wilkins. Haig, A.J., Geisser, M.E., Tong, H.C., Yamakawa, K.S.J., Quint, D.J., Hoff, J.T., . . . Phalke, V.V. (2007). Electromyographic and magnetic resonance imaging to predict lumbar stenosis, low-back pain, and no back symptoms. Journal of Bone and Joint Surgery, 89(2), 358–366. https://doi.org/ 10.2106/00004623-200702000-00018. Haig, A.J., Tong, H.C., Yamakawa, K.S., Parres, C., Quint, D.J., Chiodo, A., . . . Geisser, M.E. (2006). Predictors of pain and function in persons with spinal stenosis, low back pain, and no back pain. Spine, 31(25), 2950–2957. https:// doi.org/10.1097/ 01.brs.0000247791.97032.1e. Haig, A.J., Tong, H.C., Yamakawa, K.S., Quint, D.J., Hoff, J.T., Choido, A., . . . Parres, C.M. (2006). Spinal stenosis, back pain, or no symptoms at all? A masked study comparing radiologic and electrodiagnostic diagnoses to the clinical impression. Archives of Physical Medicine and Rehabilitation, 87(7), 897– 903. https://doi.org/10.1016/ j.apmr.2006.03.016. Hutson, M. & Ward, A. (Eds.). (2016). Oxford Textbook of Musculoskeletal Medicine (2nd ed.). Oxford, UK: Oxford University Press. Institute of Medicine, Committee on Advancing Pain Research, Care, and Education. (2011). Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC: The National Academies Press. ¨ ¨ Jonsson, B., Annertz, M., Sjoberg, C., & ¨ Stromqvist, B. (1997). A prospective and consecutive study of surgically treated lumbar spinal stenosis. Part I: Clinical features related to radiographic findings. Spine, 22(24), 2932–2937. https://doi.org/ 10.1097/00007632-199712150-00016. ¨ ¨ Jonsson, B., Annertz, M., Sjoberg, C., & ¨ Stromqvist, B. (1997). A prospective and consecutive study of surgically treated lumbar spinal stenosis. Part II: Five-year follow-up by an independent observer. Spine, 22(24), 2938–2944. https://doi.org/ 10.1097/00007632-199712150-00017. Karmarkar, A.M., Collins, D.M., Wichman, T., Franklin, A., Fitzgerald, S.G., Dicianno, B.E., . . . Cooper, R.A. (2009). Prosthesis and wheelchair use in veterans with lower-limb amputation. Journal of Rehabilitation Research & Development, 46(5), 567–576. https:// doi.org/10.1682/JRRD.2008.08.0102. Kim, Y., Morshed, S., Joseph, T., Bozic, K., Ries, M., & Ries, M.D. (2006). Clinical impact of obesity on stability following revision total hip arthroplasty. Clinical PO 00000 Frm 00013 Fmt 4701 Sfmt 4702 20657 Orthopaedics & Related Research, 453, 142–146. https://doi.org/10.1097/ 01.blo.0000238874.09390.a1. Kliegman, R.M., Stanton, B.F., Schor, N.F., St. Geme III, J.W., Behrman, R.E., (Eds.). (2016). Nelson Textbook of Pediatrics. (20th ed., Vol. 1). Philadelphia, PA: Elsevier. Lohman, C.M., Tallroth, K., Kettunen, J.A., & Lindgren, K.A. (2006). Comparisons of radiologic signs and clinical symptoms of spinal stenosis. Spine, 31(16), 1834– 1840. https://doi.org/10.1097/ 01.brs.0000227370.65573.ac. Longo, D.L., Fauci, A.S., Kasper, D.L., Hauser, S.L., Jameson, J.L., & Loscalzo, J.L. (2011). Harrison’s Principles of Internal Medicine (18th ed.). New York, NY: McGraw-Hill Medical. Mannion, A.F., Brox, J.I., & Fairbank, J.C.T. (2013). Comparison of spinal fusion and nonoperative treatment in patients with chronic low back pain: Long-term follow-up of three randomized controlled trials. The Spine Journal, 13(11), 1438–1448. https://doi.org/ 10.1016/j.spinee.2013.06.101. Martel, M.O., Finan, P.H., Dolman, A.J., Subramanian, S., Edwards, R.R., Wasan, A.D., & Jamison, R.N. (2015). Self-reports of medication side effects and painrelated activity interference in patients with chronic pain: A longitudinal cohort study. Pain. 156(6), 1092–1100. https:// doi.org/10.1097/ j.pain.0000000000000154. Martindale, J., Sulka, R. & Goodacre, J. (2015). The impact of ankylosing spondylitis/Axial spondyloarthritis on work productivity. Best Practice & Research Clinical Rheumatology, 29(3), 512–523. https://doi.org/10.1016/ j.berh.2015.04.002. Mattos, C.B., Binitie, O., & Dormans, J.P. (2012). Pathological fractures in children. Bone and Joint Research, 1(10), 272–280. https://doi.org/10.1302/20463758.110.2000120. ¨ ¨ Okmen, K., & Okmen, B.M. (2017). The efficacy of interlaminar epidural steroid administration in multilevel intervertebral disc disease with chronic low back pain: A randomized, blinded, prospective study. The Spine Journal, 17(2), 168–174. https://doi.org/10.1016/ j.spinee.2016.08.024. Onyekwelu, I., Glassman, S.D., Asher, A.L., Shaffrey, C.I., Mummaneni, P.V., & Carreon, L.Y. (2017). Impact of obesity on complications and outcomes: A comparison of fusion and nonfusion lumbar spine surgery. Journal of Neurosurgery: Spine. 26(2), 158–162. https://doi.org/10.3171/ 2016.7.SPINE16448. Puolakka, K., Ylinen, J., Neva, M.H., ¨ Kautiainen, H., & Hakkinen, A. (2008). Risk factors for back pain-related loss of working time after surgery for lumbar disc herniation: A 5-year follow-up study. European Spine Journal, 17(3), 386–392. https://doi.org/10.1007/s00586007-0552-2. Reed, P. (2005). The Medical Disability Advisor (5th ed.). Westminster, CO: Reed Group, Ltd. E:\FR\FM\07MYP3.SGM 07MYP3 daltland on DSKBBV9HB2PROD with PROPOSALS3 20658 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules Rondinelli, R.D., Genovese, E., Katz, R.T., Mayer, T.G., Mueller, K., Ranavaya, M. (Eds.). (2007). Guides to the Evaluation of Permanent Impairment (6th ed.). Chicago, IL: American Medical Association. Shin, E.K., Kim, C.H., Chung, C.K., Choi, Y., Yim, D., Jung, W., . . . Kim, S.M. (2017). 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(2010) Mobility limitations. In: JH Stone, M Blouin, (Eds). International encyclopedia of rehabilitation. Center for International Rehabilitation Research Information and Exchange. https:// cirrie.buffalo.edu/encyclopedia/en/ article/259/. Young, A.E., & Murphy, G.C. (2009). Employment status after spinal cord injury (1992–2005): A review with implications for interpretation, evaluation, further research, and clinical practice. International Journal of Rehabilitation Research, 32(1), 1–11. https://doi.org/10.1097/ MRR.0b013e32831c8b19. (42 U.S.C. 402, 405(a)–(b) and (d)–(h), 416(i), 421(a) and (h)–(j), 422(c), 423, 425, and 902(a)(5)); sec. 211(b), Pub. L. 104–193, 110 Stat. 2105, 2189; sec. 202, Pub. L. 108–203, 118 Stat. 509 (42 U.S.C. 902 note). 2. Amend appendix 1 to subpart P of part 404 as follows: ■ a. Revise item 2 of the introductory text before part A; ■ b. Amend part A by revising the body system name for section 1.00 in the table of contents; ■ c. Revise section 1.00 of part A; ■ d. Revise the second sentence of paragraph 4.00G4b of part A; ■ e. Redesignate current 14.00C2 through 14.00C12 of part A as follows: ■ Old section 14.00C2 14.00C3 14.00C4 14.00C5 14.00C6 14.00C7 14.00C8 14.00C9 14.00C10 14.00C11 14.00C12 We included these references in the rulemaking record for these proposed rules and will make them available for inspection by interested individuals who make arrangements with the contact person identified above. (Catalog of Federal Domestic Assistance Program Nos. 96.001, Social Security– Disability Insurance; 96.002, Social Security– Retirement Insurance; 96.004, Social Security–Survivors Insurance; and 96.006, Supplemental Security Income). List of Subjects 20 CFR Part 404 Administrative practice and procedure; Blind, Disability benefits; Old-Age, survivors, and disability insurance; Reporting and recordkeeping requirements; Social Security. 20 CFR Part 416 Administrative practice and procedure, Blind, Disability benefits, Public assistance programs, Reporting and recordkeeping requirements, Supplemental Security Income (SSI). Nancy A. Berryhill, Acting Commissioner of Social Security. For the reasons set out in the preamble, we propose to amend 20 CFR, chapter III, part 404, subpart P as set forth below: PART 404—FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950–) Subpart P—[Amended] 1. The authority citation for subpart P of part 404 continues to read as follows: ■ Authority: Secs. 202, 205(a)–(b) and (d)– (h), 216(i), 221(a) and (h)–(j), 222(c), 223, 225, and 702(a)(5) of the Social Security Act PO 00000 Frm 00014 Fmt 4701 Sfmt 4702 New section 14.00C3 14.00C4 14.00C6 14.00C7 14.00C8 14.00C9 14.00C10 14.00C11 14.00C12 14.00C13 14.00C14 f. Add new paragraphs 14.00C2 and 14.00C5 to part A; ■ g. Revise 14.00C8 through 14.00C10; ■ h. Revise the first sentence of paragraph 14.00D4c(i) of part A; ■ i. Revise the second and third sentences of paragraph 14.00D6a of part A; ■ j. Revise paragraph 14.00D6e(i) and the first sentence of 14.00D6e(ii) of part A; ■ k. Revise 14.04B, 14.04C2, and 14.05A of part A; ■ l. Revise 14.09A and the first sentence of 14.09B of part A; ■ m. Amend part B by revising the body system name for section 101.00 in the table of contents; ■ n. Revise section 101.00 of part B; ■ o. Revise the second sentence of paragraph 104.00F9b of part B; ■ p. Redesignate current 114.00C2 through 114.00C12 of part B as follows: ■ Old section 114.00C2 .............................. 114.00C3 .............................. 114.00C4 .............................. 114.00C5 .............................. 114.00C6 .............................. 114.00C7 .............................. 114.00C8 .............................. 114.00C9 .............................. 114.00C10 ............................ 114.00C11 ............................ 114.00C12 ............................ New section 114.00C3 114.00C4 114.00C6 114.00C7 114.00C8 114.00C9 114.00C10 114.00C11 114.00C12 114.00C13 114.00C14 q. Add new paragraphs 114.00C2 and 114.00C5 to part B; ■ E:\FR\FM\07MYP3.SGM 07MYP3 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules r. Revise 114.00C8 through 114.00C10; ■ s. Revise the first sentence of paragraph 114.00D4c(ii) of part B; ■ t. Revise the second and third sentences of paragraph 114.00D6a of part B; ■ u. Revise paragraph 114.00D6e(i) and the first sentence of 114.00D6e(ii) of part B; ■ v. Revise listings 114.04B, 114.04C2, and 114.05A of part B; and ■ w. Revise 114.09A and the heading of 114.09B of part B. The revisions read as follows: ■ Appendix 1 to Subpart P of Part 404— Listing of Impairments * * * * * 2. Musculoskeletal Disorders (1.00 and 101.00): [THIS EXPIRES 5 YEARS FROM THE EFFECTIVE DATE OF THE FINAL RULES]. * * * * * * * * Part A * * 1.00 Musculoskeletal Disorders. * * * * * 1.00 Musculoskeletal Disorders A. Which disorders do we evaluate under these listings? 1. We evaluate disorders of the skeletal spine (vertebral column) or of the upper or lower extremities that affect musculoskeletal functioning in the musculoskeletal body system listings. We use the term ‘‘skeletal’’ when we are referring to the structure of the bony skeleton. The skeletal spine refers to the bony structures, ligaments, and discs making up the spine. We refer to the ‘‘skeletal’’ spine in some musculoskeletal listings to differentiate it from the neurological spine (see 1.00B1). Disorders may be congenital or acquired, and may include deformities, amputations, or other musculoskeletal abnormalities. These disorders may involve the bones or major joints; or the tendons, ligaments, muscles, or other soft tissues. 2. We also evaluate soft tissue abnormalities or injuries (including burns) that are under continuing surgical management (see 1.00L1). The abnormalities or injuries may affect any part of the body, including the face and skull. B. Which related disorders do we evaluate under other listings? 1. We evaluate a disorder or injury of the skeletal spine that results in damage to, and neurological dysfunction of, the spinal cord and its associated nerves (for example, paraplegia or quadriplegia) under the criteria in 11.00 Neurological Disorders. 2. We evaluate inflammatory arthritis (for example, rheumatoid arthritis) under the criteria in 14.00 Immune System Disorders. 3. We evaluate curvatures of the skeletal spine under these musculoskeletal disorders listings and other listings as appropriate for the affected body system. Curvatures of the skeletal spine that affect musculoskeletal functioning are evaluated under 1.15 Disorders of the skeletal spine resulting in compromise of a nerve root(s). If a curvature of the skeletal spine is under continuing surgical management, we can evaluate it for medical equivalence to 1.21 Soft tissue injury or abnormality under continuing surgical management. Curvatures of the skeletal spine may also adversely affect functioning in body systems other than the musculoskeletal system. For example, the curvature may interfere with your ability to breathe (see 3.00 Respiratory Disorders); there may be impaired myocardial function (see 4.00 Cardiovascular System); or there may be disfigurement resulting in social withdrawal or depression (see 12.00 Mental Disorders). 4. We evaluate non-healing or pathological fractures due to cancer, whether it is a primary site or metastases, under the criteria in 13.00 Cancer (Malignant Neoplastic Diseases). 5. We evaluate the leg pain associated with peripheral vascular claudication, as well as diabetic foot ulcers, under the criteria in 4.00 Cardiovascular System. 6. We evaluate burns that do not require continuing surgical management under the criteria in 8.00 Skin Disorders. C. What evidence do we need to evaluate your musculoskeletal disorder under these listings? 1. General. To establish the presence of a musculoskeletal disorder as a medically determinable impairment, we need objective medical evidence from an acceptable medical source who has examined you for the 20659 disorder. To assess the severity and duration of your disorder, we evaluate evidence from both medical and nonmedical sources who can describe how you function. If there is no record of ongoing medical treatment for your disorder, we will follow the guidelines in 1.00P How do we evaluate the severity and duration of your established musculoskeletal disorder when there is no record of ongoing treatment? We will determine the extent and kinds of evidence we need from medical and non-medical sources based on the individual facts about your disorder. For our basic rules on evidence, see §§ 404.1502, 404.1512, 404.1513, 404.1513a, 404.1520b, 416.902, 416.912, 416.913, 416.913a, and 416.920b of this chapter. For our rules on evidence about your symptoms, see §§ 404.1529 and 416.929 of this chapter. 2. Physical examination report(s). In the report(s) of your physical examination, we need a detailed description of the orthopedic, neurologic, or other objective clinical findings appropriate to your specific musculoskeletal disorder. We require objective clinical findings from the medical source’s direct observations during your physical examination, not simply his or her report of your statements about your symptoms and limitations. When the medical source reports that a clinical test sign(s) is positive, unless we have evidence to the contrary, we will assume that he or she performed the test properly. For instance, we will assume a straight-leg raising test was conducted properly, i.e., in a sitting and supine position, even if the medical source does not specify the positions in which the test was performed. In the absence of evidence to the contrary, we will accept the medical source’s interpretation of the test. If you use an assistive device (see 1.00C6), the report must support the medical need for the device. If reduction in muscle strength is a factor, we require medical documentation of measurement of the strength of the muscle(s) in question, generally based on a grading system of 0 to 5. Zero (0) indicates complete loss of strength and 5 indicates maximum strength, consistent with Table 1 below. The documentation should also include measurements of grip and pinch strength, if there is evidence of involvement of one or both hands. TABLE 1 daltland on DSKBBV9HB2PROD with PROPOSALS3 Grading Scale of Muscle Function: 0 to 5 0 1 2 3 4 5 ...................................................... ...................................................... ...................................................... ...................................................... ...................................................... ...................................................... None .............................................. Trace .............................................. Poor ............................................... Fair ................................................. Good .............................................. Normal ........................................... 3. Laboratory findings: Imaging and other diagnostic tests a. Imaging refers to medical imaging techniques, such as x-ray, computed tomography (CT), magnetic resonance imaging (MRI), and radionuclide scanning. VerDate Sep<11>2014 21:10 May 04, 2018 Jkt 244001 No visible or palpable contraction. Visible or palpable contraction with no motion. Active range of motion (ROM) with gravity eliminated. Active ROM against gravity only, without resistance. Active ROM against gravity, moderate resistance. Active ROM against gravity, maximum resistance. For the purpose of these listings, the imaging technique(s) must be consistent with the generally accepted standards of medical knowledge and clinical practice. PO 00000 Frm 00015 Fmt 4701 Sfmt 4702 b. Findings on imaging must have lasted, or must be expected to last, for a continuous period of at least 12 months. c. Imaging and other diagnostic tests can provide evidence of physical abnormalities; however, they may correlate poorly with E:\FR\FM\07MYP3.SGM 07MYP3 daltland on DSKBBV9HB2PROD with PROPOSALS3 20660 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules your symptoms, including pain, or with your musculoskeletal functioning. Accordingly, we cannot use such tests as a substitute for physical examination findings about your ability to function, nor can we infer severity or functional limitations based solely on such tests. d. For our policies about when we will purchase imaging and other diagnostic tests, see §§ 404.1519k, 404.1519m, 416.919k, and 416.919m of this chapter. 4. Operative reports. If you have had a surgical procedure(s), we need either the operative reports, including details of the findings at surgery and information about any medical complications that may have occurred, or confirmatory evidence of the surgical procedure(s) from a medical source (for example, detailed follow-up reports or notations in the medical records concerning your past medical history). 5. Effects of treatment a. General. Treatments for musculoskeletal disorders may have beneficial or adverse effects, and responses to treatment vary from person to person. We will evaluate all of the effects of treatment (including surgical treatment, medications, and therapy) on the symptoms, signs, and laboratory findings of your musculoskeletal disorder, and on your musculoskeletal functioning. b. Response to treatment. To evaluate your musculoskeletal functioning in response to treatment, we need specific information related to your impairment, including the following: A description of your medications, including frequency of administration; the type and frequency of therapy you receive; and a description of your response to treatment and any complications you experience related to your impairment. The effects of treatment may be temporary or long-term. We need information over a sufficient period to determine the effect of treatment on your current musculoskeletal functioning and to permit reasonable projections about your future functioning. In some cases, we will need additional evidence to make an assessment about your response to treatment. Depending upon the timing of this treatment in relation to the alleged onset date of disability, we may need to defer evaluation of the impairment for a period of up to 3 months from the date treatment began to permit consideration of treatment effects, unless we can make a determination or decision using the evidence we have. 6. Assistive devices a. General. An assistive device, for the purposes of these listings, is any device that is used to improve stability, dexterity, or mobility. An assistive device can be worn (see 1.00C6b and c), or hand-held (see 1.00C6d). If you use any type of assistive device(s), we need evidence from a medical source regarding the documented medical need for the device(s). When we use the term ‘‘documented medical need,’’ we mean that there is evidence from a medical source(s) in the medical record that supports your need for an assistive device (see §§ 404.1513 and 416.913 of this chapter). The evidence must include documentation from a medical source(s) describing any limitation(s) in your upper or lower extremity functioning that supports your need for the assistive device(s), VerDate Sep<11>2014 21:10 May 04, 2018 Jkt 244001 and the circumstances for which you need it. The evidence does not have to include a specific prescription for the device(s). b. Prosthesis(es). A prosthesis is a wearable device, such as an artificial limb, that takes the place of an absent body part. We need evidence from a medical source documenting your ability to walk, or to perform fine and gross movements (see 1.00E3), with the prosthesis(es) in place. When amputation(s) involves a lower extremity or extremities, it is not necessary to evaluate your ability to walk without the prosthesis(es) in place. If you cannot use your prosthesis(es) due to complications affecting your residual limb(s), we need documentation from a medical source regarding the condition of your residual limb(s) and the medical basis for your inability to use the prosthesis(es). c. Orthosis(es). An orthosis is a wearable device that prevents or corrects a dysfunction or deformity by aligning or supporting the affected body part. An orthosis may also be referred to as a ‘‘brace.’’ If you have an orthosis(es), we need evidence from a medical source documenting your ability to walk, or to perform fine and gross movements, with the orthosis(es) in place. If you cannot use your orthosis(es), we need evidence from a medical source documenting the medical basis for your inability to use the device(s). d. Hand-held assistive devices. Hand-held assistive devices include canes, crutches, or walkers, and are carried in your hand(s) to support or aid you in walking. When you require a one-handed assistive device for ambulation, such as a cane or single crutch, and your other upper extremity has limitations preventing its use for fine or gross movement(s) (see 1.00E3), the need for the assistive device limits the use of both upper extremities. If you use a hand-held assistive device, we need evidence from a medical source documenting your need for the device(s) and describing how you walk with the device(s). 7. Longitudinal evidence a. We generally need a longitudinal medical record to assess the duration of your musculoskeletal disorder, because symptoms, signs, and laboratory findings related to most musculoskeletal disorders may wax and wane, may improve over time, or may respond to treatment. By providing evidence over an extended period, the medical record will show whether your musculoskeletal functioning is improving, worsening, or unchanging. b. For 1.19 Pathologic fractures due to any cause and 1.21 Soft tissue injury or abnormality under continuing surgical management, the required 12-month duration period is stated in the listing itself. For 1.20A (amputation of both upper extremities) or 1.20B (hemipelvectomy or hip disarticulation), we presume satisfaction of the duration requirement. c. For all listings not referenced in 1.00C7b above, all of the required criteria must be present simultaneously, or within a close proximity of time, to satisfy the level of severity needed to meet the listing. When we use the term ‘‘close proximity of time,’’ we mean that all of the relevant criteria have to appear in the medical record within a period PO 00000 Frm 00016 Fmt 4701 Sfmt 4702 not to exceed 4 months of one another. When the criterion in question is imaging, we mean those findings on imaging that we could reasonably expect to have been present at the date of impairment or date of onset. To meet a listing that uses the word ‘‘and’’ or ‘‘AND’’ to link the elements of the required criteria, the medical record must establish the simultaneous presence, or presence within a close proximity of time, of all the required medical criteria. Once this level of severity is established, the medical record must also show that this level of severity has continued, or is expected to continue, for a continuous period of at least 12 months. 8. Surgical treatment For some musculoskeletal disorders, a medical source may recommend surgery. If you have not yet had the recommended surgery, we will not deny your claim based on an assumption that surgery will resolve or improve your disorder. We will assess each case on an individual basis. Depending on your response to treatment, or depending on your medical sources’ treatment plans, we may defer our findings regarding the effect of surgical intervention until a sufficient period has passed to permit proper consideration or judgment about your future functioning. See 1.00C5b Response to treatment. D. How do we consider symptoms, including pain, under these listings? 1. Individuals with musculoskeletal disorders may experience pain or other symptoms; however, statements alone about your pain or other symptoms cannot establish that you are disabled. Further, an alleged or reported increase in the intensity of a symptom, such as pain, no matter how severe, cannot be substituted for a medical sign or diagnostic finding present in the listing criteria. Pain is included as just one consideration in paragraph A in listings 1.15, 1.16, and 1.18, but is not required to satisfy the criteria in these listings. Examples of other findings that will satisfy the criteria in paragraph A include muscle fatigue, nonradicular distribution of sensory loss in one or both extremities, and joint stiffness. 2. To consider your pain, we require objective medical evidence from an acceptable medical source showing the existence of a medically determinable impairment(s) (MDI) that could reasonably be expected to produce the pain. When your musculoskeletal MDI could reasonably be expected to produce the pain or other symptoms alleged, we consider all your symptoms, including pain, and the extent to which your symptoms can reasonably be accepted as consistent with all of the objective medical evidence, including medical signs and laboratory or diagnostic findings. See §§ 404.1529 and 416.929 of this chapter for information on how we evaluate pain or other symptoms related to a musculoskeletal impairment. E. How do we use the functional criteria under these listings? 1. General. We will determine that your musculoskeletal disorder meets a listing if it satisfies the medical criteria; includes at least one of the functional criteria, if included in the listing; and satisfies the 12-month duration requirement. We will use the relevant evidence that we have to evaluate E:\FR\FM\07MYP3.SGM 07MYP3 daltland on DSKBBV9HB2PROD with PROPOSALS3 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules your musculoskeletal functioning with respect to the work environment rather than the home environment. For example, an ability to walk independently at home without an assistive device does not, in and of itself, indicate an ability to walk without an assistive device in a work environment. 2. Functional criteria. The functional criteria are based on impairment-related physical limitations in your ability to use both upper extremities, one or both lower extremities, or a combination of one upper and one lower extremity. A musculoskeletal disorder satisfies the functional criteria of a listing when the medical documentation shows the presence of at least one of the impairment-related limitations cited in the listing. The required impairment-related physical limitation of musculoskeletal functioning must have lasted, or be expected to last, for a continuous period of at least 12 months, medically documented by one of the following: a. A documented medical need (see 1.00C6a) for a walker, bilateral canes, or bilateral crutches (see 1.00C6d); b. An inability to use one upper extremity to independently initiate, sustain, and complete work-related activities involving fine and gross movements (see 1.00E3), and a documented medical need (see 1.00C6a) for a one-handed assistive device (see 1.00C6d) that requires the use of your other upper extremity; c. An inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete work-related activities involving fine and gross movements (see 1.00E3). 3. Fine and gross movements. Fine movements, for the purposes of these listings, involve use of your wrists, hands, and fingers; such movements include picking, pinching, manipulating, and fingering. Gross movements involve use of your shoulders, upper arms, forearms, and hands; such movements include handling, gripping, grasping, holding, turning, and reaching. Gross movements also include exertional abilities such as lifting, carrying, pushing, and pulling. Examples of inability to perform fine and gross movements include, but are not limited to, the inability to take care of personal hygiene, the inability to sort and handle papers or files, and the inability to place files in a file cabinet at or above waist level. 4. When we do not use the functional criteria. We do not use the functional criteria to evaluate amputation of both upper extremities under 1.20A, hemipelvectomy or hip disarticulation under 1.20B, and soft tissue injuries or abnormalities under continuing surgical management under 1.21. F. What do we consider when we evaluate disorders of the skeletal spine resulting in compromise of a nerve root(s) (1.15)? 1. General. We consider musculoskeletal disorders such as herniated nucleus pulposus, spinal osteoarthritis (spondylosis), vertebral slippage (spondylolisthesis), degenerative disc disease, facet arthritis, and vertebral fracture or dislocation. Spinal disorders may cause cervical or lumbar spine dysfunction when abnormalities of the skeletal spine compromise nerve roots of the VerDate Sep<11>2014 21:10 May 04, 2018 Jkt 244001 cervical spine, a nerve root of the lumbar spine, or a nerve root of both cervical and lumbar spines. 2. Compromise of a nerve root(s). Compromise of a nerve root(s), sometimes referred to as ‘‘nerve root impingement,’’ is a term used when a physical object is seen pushing on the nerve root in an imaging study or during surgery. Objects such as tumors, herniated discs, foreign bodies, or arthritic spurs may cause compromise of a nerve root. It can occur when a musculoskeletal disorder produces irritation, inflammation, or compression of the nerve root(s) as it exits the skeletal spine between the vertebrae. Related symptoms must be associated with, or follow the path of, the specific nerve root(s), thereby presenting a neuro-anatomic (usually referred to as ‘‘radicular’’) distribution of symptoms and signs, including pain, paresthesia (for example, burning, prickling, or tingling), sensory loss, and usually muscle weakness specific to the affected nerve root(s). a. Compromise of unilateral nerve root of the cervical spine. Compromise of a nerve root as it exits the cervical spine between the vertebrae may affect the functioning of the associated upper extremity. The clinical examination reproduces the related symptoms based on radicular signs and clinical tests (for example, a positive Spurling’s test) appropriate to the specific cervical nerve root. b. Compromise of bilateral nerve roots of the cervical spine. Although uncommon, if compromise of a nerve root occurs on both sides of the cervical spinal column, functioning of both upper extremities may be limited. c. Compromise of a nerve root(s) of the lumbar spine. Compromise of a nerve root as it exits the lumbar spine between the vertebrae may limit the functioning of the associated lower extremity. The clinical examination reproduces the related symptoms based on radicular signs and clinical tests. When a nerve root of the lumbar spine is compromised, we require a positive straight-leg raising test (also known as a Lasegue test) in both supine and sitting positions appropriate to the specific lumbar nerve root that is compromised. (See 1.00C2 for guidance on interpreting information from a physical examination report.) G. What do we consider when we evaluate lumbar spinal stenosis resulting in compromise of the cauda equina (1.16)? 1. We consider the limiting effects of pain, sensory changes, and muscle weakness caused by compromise of the cauda equina due to lumbar spinal stenosis. The cauda equina is a bundle of nerve roots that descends from the lower part of the spinal cord. Lumbar spinal stenosis can compress the nerves of the cauda equina, causing sensory changes and muscle weakness that may affect your ability to stand or walk. Pain related to compromise of the cauda equina is ‘‘nonradicular,’’ because it is not typically associated with a specific nerve root (as is radicular pain in the cervical or lumbar spine). 2. Compromise of the cauda equina due to spinal stenosis can affect your ability to walk because of neurogenic claudication (also PO 00000 Frm 00017 Fmt 4701 Sfmt 4702 20661 known as pseudoclaudication), a disorder usually causing non-radicular pain that starts in the low back and radiates bilaterally (or less commonly, unilaterally) into the buttocks and lower extremities (or extremity). Extension of the lumbar spine, as when walking or merely standing, provokes the pain of neurogenic claudication. It is relieved by forward flexion of the lumbar spine or by sitting. In contrast, the leg pain associated with peripheral vascular claudication results from inadequate arterial blood flow to a lower extremity. It occurs repeatedly and consistently when a person walks a certain distance and is relieved when the person rests. H. What do we consider when we evaluate reconstructive surgery or surgical arthrodesis of a major weight-bearing joint (1.17)? 1. We consider reconstructive surgery or surgical arthrodesis when an acceptable medical source(s) documents the surgical procedure(s) and associated medical treatments to restore function of the affected body part(s). The reconstructive surgery may be a single event or it may be a series of procedures directed toward the salvage or restoration of functional use of the affected joint. 2. Major weight-bearing joints. The major weight-bearing joints are the hip, knee, and ankle-foot. The ankle and foot are considered together as one major joint. 3. Surgical arthrodesis. Surgical arthrodesis is the artificial fusion of the bones that form a joint, essentially eliminating the joint. I. What do we consider when we evaluate abnormality of a major joint(s) in any extremity (1.18)? 1. General. We consider musculoskeletal disorders that produce anatomical abnormalities of major joints of the extremities, resulting in functional abnormalities in the upper or lower extremities (for example, osteoarthritis and chronic infections of bones and joints, surgical arthrodesis of a joint). Major joint of an upper extremity refers to the shoulder, elbow, and wrist-hand. We consider the wrist and hand together as one major joint. Major joint of a lower extremity refers to the hip, knee, and ankle-foot. We consider the ankle and hindfoot together as one major joint, because it is necessary for walking. Abnormalities affecting the joints may include ligamentous laxity or rupture, soft tissue contracture, or tendon rupture, and can cause muscle weakness of the affected body part. 2. How do we define abnormality in the extremities? An anatomical abnormality in any extremity(ies) is one that is readily observable by a medical source during a physical examination (for example, subluxation or contracture), or is present on imaging (for example, ankylosis, bony destruction, joint space narrowing, or deformity). A functional abnormality is abnormal motion or instability of the affected part(s), including limitation of motion, excessive motion (hypermobility), movement outside the normal plane of motion for the joint (for example, lateral deviation), or fixation of the affected parts. J. What do we consider when we evaluate pathologic fractures due to any cause (1.19)? E:\FR\FM\07MYP3.SGM 07MYP3 daltland on DSKBBV9HB2PROD with PROPOSALS3 20662 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules We consider pathologic fractures of the bones in the skeletal spine, extremities, or other parts of the skeletal system. Pathologic fractures result from disorders that weaken the bones, making them vulnerable to breakage. For non-healing or complex traumatic fractures without accompanying pathology, see 1.22 Non-healing or complex fracture of the femur, tibia, pelvis, or one or more of the tarsal bones or 1.23 Non-healing or complex fracture of an upper extremity. Pathologic fractures may occur with osteoporosis, osteogenesis imperfecta or any other skeletal dysplasias, side effects of medications, and disorders of the endocrine or other body systems. They must occur on separate, distinct occasions, rather than multiple fractures occurring at the same time, but they may affect the same bone(s) multiple times. There is no required period between the incidents of fracture(s), but they must all occur within a 12-month period; for example, separate incidents may occur within hours or days of each other. However, the associated limitation(s) of function must last, or be expected to last, at least 12 months. K. What do we consider when we evaluate amputation due to any cause (1.20)? 1. General. We consider amputation (the full or partial loss or absence of any extremity) due to any cause, including trauma, congenital abnormality or absence, surgery for treatment of conditions such as cancer or infection, or complications of peripheral vascular disease or diabetes mellitus. 2. Amputation of both upper extremities (1.20A). Upper extremity amputations, for the purposes of this listing, may occur at any level above the wrists (carpal joints), up to and including disarticulation of the shoulder (glenohumeral) joint. We do not evaluate amputations below the wrists under this listing, because the resulting limitation of function of the thumb(s), finger(s), or hand(s) will vary, depending on the extent of loss and corresponding effect on fine and gross movements (see 1.00E3). For amputations below the wrist, we will follow the remaining steps of the sequential evaluation process (see §§ 404.1520 and 416.920 of this chapter). 3. Hemipelvectomy or hip disarticulation (1.20B). Hemipelvectomy involves amputation of an entire lower extremity through the sacroiliac joint. Hip disarticulation involves amputation of an entire lower extremity through the hip joint capsule and closure of the remaining musculature over the exposed acetabular bone. 4. Amputation of one upper extremity at any level above the wrist and one lower extremity at or above the ankle (1.20C). We evaluate the absence of one upper extremity and one lower extremity with regard to whether you have a documented medical need (see 1.00C6a) for a one-handed assistive device (see 1.00C6d), such as a cane or crutch. In this situation, you may wear a prosthesis (see 1.00C6b) on your lower extremity, but nevertheless have a documented medical need for a one-handed assistive device. If you do, you would need to use your other upper extremity to hold the assistive device, making the extremity unavailable to perform other fine and gross VerDate Sep<11>2014 21:10 May 04, 2018 Jkt 244001 movements (see 1.00E3) such as carrying. In such a case, your disorder would meet this listing. 5. Amputation of one or both lower extremities at or above the ankle (tarsal joint) (1.20D). When we evaluate amputations of one or both lower extremities: a. We consider the condition of your residual limb(s), and whether you can wear a prosthesis(es) (see 1.00C6b). When you have a prosthesis(es), we will examine your residual limb with the prosthesis(es) in place. If you are unable to use a prosthesis(es) because of residual limb complications that have lasted, or are expected to last, for at least 12 months, and you are not currently undergoing surgical management (see 1.00L) of your condition, we evaluate your disorder under this listing. b. Under 1.20D ‘‘Amputation of one or both lower extremities at or above the ankle (tarsal joint),’’ we consider whether you have a documented medical need (see 1.00C6a) for a hand-held assistive device(s) (1.00C) and your ability to walk with the device(s). c. If you have a non-healing residual limb(s) and are receiving ongoing surgical treatment expected to re-establish or improve function, and that ongoing surgical treatment has not ended, or is not expected to end, within at least 12 months of the initiation of the surgical management (see 1.00L1), we evaluate your disorder under 1.21 Soft tissue injury or abnormality under continuing surgical management. L. What do we consider when we evaluate soft tissue injuries or abnormalities under continuing surgical management (1.21)? 1. General. a. We consider any soft tissue injury or abnormality involving the soft tissues of the body, whether congenital or acquired, when an acceptable medical source(s) documents the need for ongoing surgical procedures and associated medical treatments to restore function of the affected body part(s). Surgical management includes the surgery(-ies) itself, as well as various post-surgical procedures, surgical complications, infections or other medical complications, related illnesses, or related treatments that delay a person’s attainment of maximum benefit from surgery. b. Surgical procedures and associated treatments typically take place over extended periods, which may render you unable to perform work-related activity on a sustained basis. To document such inability, we must have evidence from an acceptable medical source(s) confirming that the surgical management has continued, or is expected to continue, for at least 12 months from the date of the first surgical intervention. These procedures and treatments must be directed toward saving, reconstructing, or replacing the affected part of the body to re-establish or improve its function, and not for cosmetic appearances alone. c. Examples include malformations, third and fourth degree burns, crush injuries, craniofacial injuries, avulsive injuries, and amputations with complications of the residual limb(s). d. We evaluate skeletal spine abnormalities or injuries under 1.15 Disorders of the skeletal spine resulting in compromise of a nerve root(s), or 1.16 Lumbar spinal stenosis PO 00000 Frm 00018 Fmt 4701 Sfmt 4702 resulting in compromise of the cauda equina, as appropriate. We evaluate abnormalities or injuries of bones in the lower extremities under 1.17 Reconstructive surgery or surgical arthrodesis of a major weight-bearing joint, 1.18 Abnormality of a major joint(s) in any extremity, or 1.22 Non-healing or complex fracture of the femur, tibia, pelvis, or one or more of the tarsal bones. We evaluate abnormalities or injuries of bones in the upper extremities under 1.18 Abnormality of a major joint(s) in any extremity, or 1.23 Non-healing or complex fracture of an upper extremity. 2. Documentation. In addition to the objective medical evidence we need to establish your soft tissue injury or abnormality, we also need all of the following medically documented evidence about your continuing surgical management: a. Operative reports and related laboratory findings; b. Records of post-surgical procedures; c. Records of any surgical or medical complications (for example, related infections or systemic illnesses); d. Records of any prolonged post-operative recovery periods and related treatments (for example, surgeries and treatments for burns); e. An acceptable medical source’s plans for additional surgeries; and f. Records detailing any other factors that have delayed, or that an acceptable medical source expects to delay, the saving, restoring, or replacing of the involved part for a continuous period of at least 12 months following the initiation of the surgical management. 3. Burns. Third- and fourth-degree burns damage or destroy nerve tissue, reducing or preventing transmission of signals through those nerves. Such burns frequently require multiple surgical procedures and related therapies to re-establish or improve function, which we evaluate under 1.21 Soft tissue injury or abnormality under continuing surgical management. When burns are no longer under continuing surgical management, we evaluate the residual impairment(s) (see 1.00O). When the residual impairment(s) affects the musculoskeletal system, as often occurs in third and fourth degree burns, it can result in permanent musculoskeletal tissue loss, joint contractures, or loss of extremities. We will evaluate such impairments under the relevant musculoskeletal listing(s), for example, 1.18 Abnormality of a major joint(s) in any extremity or 1.20 Amputation due to any cause. When the residual impairment(s) involves another body system(s), we will evaluate the impairment(s) under the relevant body system listing (for example, 8.08 Burns). 4. Craniofacial injuries. Surgeons may treat craniofacial injuries with multiple surgical procedures. These injuries may affect vision, hearing, speech, and the initiation of the digestive process, including mastication. When the craniofacial injury-related residual impairment(s) involves another body system(s), we will evaluate the impairment(s) under the relevant body system listings. See 1.00O regarding evaluation of residual impairment(s). M. What do we consider when we evaluate non-healing or complex fractures of the E:\FR\FM\07MYP3.SGM 07MYP3 daltland on DSKBBV9HB2PROD with PROPOSALS3 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules femur, tibia, pelvis, or one or more of the tarsal bones (1.22)? 1. We evaluate a non-healing (nonunion) or complex fracture of the femur, tibia, pelvis, or one or more of the tarsal bones with regard to whether you have a documented medical need (see 1.00C6a) for a bilateral (twohanded) assistive device (see 1.00C6d), such as a walker or bilateral crutches. 2. Non-healing fracture. A non-healing fracture is a fracture that has failed to unite completely. Nonunion is usually established when a minimum of 9 months has elapsed since the injury and the fracture site has shown no progressive signs of healing for a minimum of 3 months. 3. Complex fracture. A fracture is complex when one or more of the following occur: a. Comminuted (broken into many pieces) bone fragments, b. Multiple fractures in a single bone, c. Bone loss due to severe trauma, d. Damage to the surrounding soft tissue, e. Severe cartilage damage to the associated joint, or f. Dislocation of the associated joint. 4. When a complex fracture involves soft tissue damage, the treatment may involve continuing surgical management to restore or improve functioning. In such cases, we may evaluate the fracture(s) under 1.21 Soft tissue injury or abnormality under continuing surgical management. N. What do we consider when we evaluate non-healing or complex fractures of an upper extremity (1.23)? 1. We evaluate a non-healing (nonunion) or complex fracture of an upper extremity under continuing surgical management (see 1.00L1a) with regard to whether you have an inability to use both upper extremities to independently initiate, sustain, and complete fine and gross movements. 2. Non-healing fracture. A non-healing fracture is a fracture that has failed to unite completely. Nonunion is usually established when a minimum of 9 months have elapsed since the injury and the fracture site has shown no progressive signs of healing for a minimum of 3 months. 3. Complex fracture. A fracture is complex when one or more of the following occur: a. Comminuted (broken into many pieces) bone fragments, b. Multiple fractures in a single bone, c. Bone loss due to severe trauma, d. Damage to the surrounding soft tissue, e. Severe cartilage damage to the associated joint, or f. Dislocation of the associated joint. O. How do we determine when your soft tissue injury or abnormality or your upper extremity fracture is no longer under continuing surgical management or you have received maximum therapeutic benefit? 1. Your soft tissue injury or abnormality or your upper extremity fracture is no longer under continuing surgical management when the last surgical procedure or medical treatment directed toward the reestablishment or improvement of function of the involved part has occurred. We will find that you have received maximum therapeutic benefit from treatment if there are no significant changes in physical findings or on appropriate imaging for any 6-month period VerDate Sep<11>2014 21:10 May 04, 2018 Jkt 244001 after the last surgical procedure or medical treatment. We may also find that you have received maximum therapeutic benefit if your medical source(s) indicates that further improvement is not expected after the last surgical procedure or medical treatment. 2. When you have received maximum therapeutic benefit from treatment, we will evaluate any impairment-related residual symptoms, signs, and laboratory findings (including those on imaging), any complications associated with your surgical procedures or medical treatments, and any residual limitations in your functioning. Depending upon all of those factors, we may find that your musculoskeletal impairment is no longer severe. 3. If your impairment(s) remains severe, we will evaluate your residual limitations and all other impairment-related factors to determine whether your musculoskeletal disorder meets or medically equals another listing. If it does not, we will follow the remaining steps of the sequential evaluation process to determine whether you have the residual functional capacity (RFC) to engage in substantial gainful activity. If your impairment involves burns and remains severe, we will follow the above sequence by evaluating your impairment as described in 1.00L3. P. How do we evaluate the severity and duration of your established musculoskeletal disorder when there is no record of ongoing treatment? 1. You may not have received ongoing treatment or may not have an ongoing relationship with the medical community despite having a musculoskeletal disorder(s). In either of these situations, you will not have a longitudinal medical record for us to review when we evaluate your disorder. We may therefore ask you to attend a consultative examination to determine the severity and potential duration of your disorder (see §§ 404.1519a(b) and 416.919a(b) of this chapter). 2. In some instances, we may be able to assess the severity and duration of your musculoskeletal disorder based on your medical record and current evidence alone. If the information in your case record is not sufficient or appropriate to show that you have a musculoskeletal disorder that meets the criteria of one of the musculoskeletal disorders listings, we will follow the rules in 1.00R. Q. How do we evaluate substance use disorders that co-exist with a musculoskeletal disorder? If we find that you are disabled and there is medical evidence in your case record establishing that you have a substance use disorder that co-exists with your musculoskeletal disorder, we will determine whether your substance use disorder is a contributing factor material to the determination of disability (see §§ 404.1535 and 416.935 of this chapter). R. How do we evaluate disorders that do not meet one of the musculoskeletal listings? 1. These listings are only examples of musculoskeletal disorders that we consider severe enough to prevent your ability to engage in any gainful activity. If your musculoskeletal disorder(s) does not meet PO 00000 Frm 00019 Fmt 4701 Sfmt 4702 20663 the criteria of any of these listings, we will consider whether you have an impairment(s) that meets the criteria of a listing in another body system. 2. If you have a severe medically determinable impairment(s) that does not meet any listing, we will determine whether your impairment(s) medically equals a listing. See §§ 404.1526 and 416.926 of this chapter. If it does not medically equal a listing, we will assess your RFC. See §§ 404.1545 and 416.945 of this chapter. To assess your RFC, we may require evidence in addition to, or different from, the types of evidence that we use to determine whether your impairment(s) meets or medically equals a listing. We will use the assessment of your RFC to evaluate your claim at the fourth, and if necessary, the fifth step of the sequential evaluation process to determine whether you can perform your past work or adjust to any other work, respectively. See §§ 404.1520 and 416.920 of this chapter. 3. We use the rules in §§ 404.1594 and 416.994 of this chapter, as appropriate, when we decide whether you continue to be disabled. 1.01 Category of Impairments, Musculoskeletal Disorders 1.15 Disorders of the skeletal spine resulting in compromise of a nerve root(s) (see 1.00F), documented by A, B, C, and D: A. Symptom(s) of neuro-anatomic (radicular) distribution of one or more of the following manifestations consistent with compromise of the affected nerve root(s): 1. Pain; or 2. Paresthesias; or 3. Muscle fatigue. AND B. Radicular neurological signs present during physical examination or testing and evidenced by 1, 2, and 4; or 1, 3, and 4 below: 1. Muscle weakness; and 2. Sensory changes evidenced by: a. Decreased sensation; or b. Sensory nerve deficit (abnormal sensory nerve latency) on electrodiagnostic testing; or 3. Decreased deep tendon reflexes; and 4. Sign(s) of nerve root irritation, tension, or compression, consistent with compromise of the affected nerve root (see 1.00F2). AND C. Findings on imaging consistent with compromise of a nerve root(s) in the cervical or lumbosacral spine (see 1.00C3). AND D. Impairment-related physical limitation of musculoskeletal functioning that has lasted, or can be expected to last, for a continuous period of at least 12 months, and medical documentation of at least one of the following (see 1.00E): 1. A documented medical need for a walker, bilateral canes, or bilateral crutches; or 2. An inability to use one upper extremity to independently initiate, sustain, and complete work-related activities involving fine and gross movements, and a documented medical need for a one-handed assistive device that requires the use of the other upper extremity; or E:\FR\FM\07MYP3.SGM 07MYP3 daltland on DSKBBV9HB2PROD with PROPOSALS3 20664 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules 3. An inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete work-related activities involving fine and gross movements. 1.16 Lumbar spinal stenosis resulting in compromise of the cauda equina (see 1.00G), documented by A, B, C, and D: A. Symptoms of neurological compromise, such as pain, manifested as: 1. Nonradicular distribution of pain in one or both lower extremities; or 2. Nonradicular distribution of sensory loss in one or both extremities; or 3. Neurogenic claudication. AND B. Nonradicular neurological signs present during physical examination or testing and evidenced by 1 and 2, or 1 and 3, below: 1. Muscle weakness; and 2. Sensory changes evidenced by: a. Decreased sensation; or b. Sensory nerve deficit (abnormal sensory nerve latency) on electrodiagnostic testing; or c. Areflexia, trophic ulceration, or bladder or bowel incontinence. 3. Decreased deep tendon reflexes in one or both lower extremities. AND C. Findings on imaging or in an operative report consistent with compromise of the cauda equina with lumbar spinal stenosis. AND D. Impairment-related physical limitation of musculoskeletal functioning that has lasted, or can be expected to last, for a continuous period of at least 12 months, and medical documentation of at least one of the following (see 1.00E): 1. A documented medical need for a walker, bilateral canes, or bilateral crutches; or 2. An inability to use one upper extremity to independently initiate, sustain, and complete work-related activities involving fine and gross movements, and a documented medical need for a one-handed assistive device that requires the use of the other upper extremity. 1.17 Reconstructive surgery or surgical arthrodesis of a major weight-bearing joint (see 1.00H), documented by A, B, and C: A. Documented history of reconstructive surgery or surgical arthrodesis of a major weight-bearing joint. AND B. Impairment-related physical limitation of musculoskeletal functioning that has lasted, or can be expected to last, for a continuous period of at least 12 months. AND C. A documented medical need for a walker, bilateral canes, or bilateral crutches (see 1.00E). 1.18 Abnormality of a major joint(s) in any extremity (see 1.00I), documented by A, B, C, and D: A. Chronic joint pain or stiffness. AND B. Abnormal motion, instability, or immobility of the affected joint(s). AND C. Anatomical abnormality of the affected joint(s) noted on: VerDate Sep<11>2014 21:10 May 04, 2018 Jkt 244001 1. Physical examination (for example, subluxation, contracture, bony or fibrous ankylosis); or 2. Imaging (for example, joint space narrowing, bony destruction, or ankylosis or arthrodesis of the affected joint). AND D. Impairment-related physical limitation of musculoskeletal functioning that has lasted, or can be expected to last, for a continuous period of at least 12 months, and medical documentation of at least one of the following (see 1.00E): 1. A documented medical need for a walker, bilateral canes, or bilateral crutches; or 2. An inability to use one upper extremity to independently initiate, sustain, and complete work-related activities involving fine and gross movements, and a documented medical need for a one-handed assistive device that requires the use of the other upper extremity; or 3. An inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete work-related activities involving fine and gross movements. 1.19 Pathologic fractures due to any cause (see 1.00J), documented by A and B: A. Three or more medically documented pathologic fractures occurring on separate occasions within a 12-month period; AND B. Impairment-related physical limitation of musculoskeletal functioning that has lasted, or can be expected to last, for a continuous period of at least 12 months, and medical documentation of at least one of the following (see 1.00E): 1. A documented medical need for a walker, bilateral canes, or bilateral crutches; or 2. An inability to use one upper extremity to independently initiate, sustain, and complete work-related activities involving fine and gross movements, and a documented medical need for a one-handed assistive device that requires the use of the other upper extremity; or 3. An inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete work-related activities involving fine and gross movements. 1.20 Amputation due to any cause (see 1.00K), documented by A, B, C, or D: A. Amputation of both upper extremities, occurring at any level above the wrists (carpal joints), up to and including the shoulder (glenohumeral) joint. OR B. Hemipelvectomy or hip disarticulation. OR C. Amputation of one upper extremity, occurring at any level above the wrist (carpal joints), and one lower extremity at or above the ankle (tarsal joint), and medical documentation of one the following (see 1.00E): 1. The documented medical need for a onehanded assistive device requiring the use of the other upper extremity; or 2. The inability to use the remaining upper extremity to independently initiate, sustain, PO 00000 Frm 00020 Fmt 4701 Sfmt 4702 and complete work-related activities involving fine and gross movements. OR D. Amputation of one or both lower extremities at or above the ankle (tarsal joint), with complications of the residual limb that have lasted or can be expected to last for at least 12 months, and medical documentation of both 1 and 2 (see 1.00E): 1. The inability to use a prosthetic device(s); and 2. The documented medical need for a walker, bilateral canes, or bilateral crutches. 1.21 Soft tissue injury or abnormality under continuing surgical management (see 1.00L), documented by A, B, and C in the medical record: A. Evidence confirms ongoing surgical management directed towards saving, reconstructing, or replacing the affected part of the body. AND B. The surgical management has been, or is expected to be, ongoing for at least 12 months. AND C. Maximum benefit from therapy has not yet been achieved. 1.22 Non-healing or complex fracture of the femur, tibia, pelvis, or one or more of the tarsal bones (see 1.00M), documented by A and B and C: A. Solid union not evident on appropriate medically acceptable imaging and not clinically solid; AND B. Impairment-related physical limitation of musculoskeletal functioning that has lasted, or can be expected to last, for a continuous period of at least 12 months, AND C. Medical documentation of medical need for a walker, bilateral canes, or bilateral crutches (see 1.00E). 1.23 Non-healing or complex fracture of an upper extremity (see 1.00N), documented by A and B and C: A. Nonunion of a fracture, or complex fracture of the shaft of the humerus, radius, or ulna, under continuing surgical management, as defined in 1.00O, directed toward restoration of functional use of the extremity; AND B. Impairment-related physical limitation of musculoskeletal functioning that has lasted, or can be expected to last, for a continuous period of at least 12 months; AND C. Medical documentation of at least one of the following (see 1.00E): 1. An inability to use one upper extremity to independently initiate, sustain, and complete work-related activities involving fine and gross movements, and a documented medical need for a one-handed assistive device that requires the use of the other upper extremity; or 2. An inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and E:\FR\FM\07MYP3.SGM 07MYP3 20665 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules complete work-related activities involving fine and gross movements. * * * * * 4.00 CARDIOVASCULAR SYSTEM * * * * * G. Evaluating Peripheral Vascular Disease * * * * * 4. What is lymphedema and how will we evaluate it? * * * * * b. * * * We will evaluate lymphedema by considering whether the underlying cause meets or medically equals any listing or whether the lymphedema medically equals a cardiovascular listing, such as 4.11 Chronic venous insufficiency, or a musculoskeletal listing, such as 1.18 Abnormality of a major joint(s) in any extremity. * * * * * 14.00 * * * * IMMUNE SYSTEM DISORDERS * * * * * * C. Definitions * * * 2. Assistive device(s) has the same meaning as in 1.00C6a. * * * * * 5. Documented medical need has the same meaning as in 1.00C6a. * * * * * 8. Fine and gross movements has the same meaning as in 1.00E3. 9. Hand-held assistive device has the same meaning as in 1.00C6d. 10. Major joint of an upper or lower extremity has the same meaning as in 1.00I1. * * * * * D. How do we document and evaluate the listed autoimmune disorders? * * * * * 4. Polymyositis and dermatomyositis (14.05). * * * * * c. * * * (i) Weakness of your pelvic girdle muscles that results in your inability to rise independently from a squatting or sitting position or to climb stairs may be an indication that you are unable to walk without physical or mechanical assistance. * * * daltland on DSKBBV9HB2PROD with PROPOSALS3 * * * * * d. * * * 6. * * * a. General. * * * Clinically, inflammation of major joints in an upper or lower extremity may be the dominant manifestation causing difficulties with walking or performing fine and gross movements; there may be joint pain, swelling, and tenderness. The arthritis may affect other joints, or cause less limitation in walking or performing fine and gross movements. * * * * * * * * e. * * * (i) Listing-level severity in 14.09 Inflammatory arthritis is shown by the presence of an impairment-related, significant limitation cited in the criteria of these listings. In 14.09A, listing-level severity is satisfied with persistent inflammation or VerDate Sep<11>2014 21:10 May 04, 2018 Jkt 244001 deformity in one major joint in a lower extremity resulting in a documented medical need for a walker, bilateral canes, or bilateral crutches as required in 14.09A1, or one major joint in each upper extremity resulting in an impairment-related, significant limitation in the ability to perform fine and gross movements as required in 14.09A2. In 14.09C1, if you have the required ankylosis (fixation) of your cervical or dorsolumbar spine, we will find that you have an impairment-related significant limitation in your ability to see in front of you, above you, and to the side. Therefore, a listing-level impairment in the ability to walk is implicit in 14.09C1, even though you might not require bilateral upper limb assistance. (ii) Listing-level severity is shown in 14.09B, 14.09C2, and 14.09D by inflammatory arthritis that involves various combinations of complications of one or more major joints in an upper or lower extremity or other joints, such as inflammation or deformity, extra-articular features, repeated manifestations, and constitutional symptoms or signs. * * * * * * * * 14.04 Systemic sclerosis (scleroderma). As described in 14.00D3. With: * * * * * B. One of the following: 1. Toe contractures or fixed deformity of one or both feet, resulting in one of the following: a. A documented medical need for a walker, bilateral canes, or bilateral crutches (see 14.00C9); or b. An inability to use one upper extremity to independently initiate, sustain, and complete work-related activities involving fine and gross movements, and a documented medical need for a one-handed assistive device (see 14.00C9) that requires the use of the other upper extremity; or 2. Finger contractures or fixed deformity in both hands, resulting in an inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete work-related activities involving fine and gross movements; or 3. Atrophy with irreversible damage in one or both lower extremities, resulting in one of the following: a. A documented medical need for a walker, bilateral canes, or bilateral crutches (see 14.00C9); or b. An inability to use one upper extremity to independently initiate, sustain, and complete work-related activities involving fine and gross movements, and a documented medical need for a one-handed assistive device (see 14.00C9) that requires the use of the other upper extremity; or 4. Atrophy with irreversible damage in both upper extremities, resulting in an inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete work-related activities involving fine and gross movements. OR C. Raynaud’s phenomenon, characterized by: * * * * * 2. Ischemia with ulcerations of toes or fingers, resulting in one of the following: PO 00000 Frm 00021 Fmt 4701 Sfmt 4702 a. A documented medical need for a walker, bilateral canes, or bilateral crutches (see 14.00C9); or b. An inability to use one upper extremity to independently initiate, sustain, and complete work-related activities involving fine and gross movements, and a documented medical need for a one-handed assistive device (see 14.00C9) that requires the use of the other upper extremity; or c. An inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete work-related activities involving fine and gross movements. * * * * * 14.05 Polymyositis and dermatomyositis. As described in 14.00D4. With: A. Proximal limb-girdle (pelvic or shoulder) muscle weakness, resulting in one of the following: 1. A documented medical need for a walker, bilateral canes, or bilateral crutches (see 14.00C9); or 2. An inability to use one upper extremity to independently initiate, sustain, and complete work-related activities involving fine and gross movements, and a documented medical need for a one-handed assistive device (see 14.00C9) that requires the use of the other upper extremity; or 3. An inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete work-related activities involving fine and gross movements. * * * * * 14.09 Inflammatory arthritis. As described in 14.00D6. With: A. Persistent inflammation or persistent deformity of: 1. One or more major joints in a lower extremity(ies) resulting in one of the following: a. A documented medical need for a walker, bilateral canes, or bilateral crutches (see 14.00C9); or b. An inability to use one upper extremity to independently initiate, sustain, and complete work-related activities involving fine and gross movements, and a documented medical need for a one-handed assistive device (see 14.00C9) that requires the use of the other upper extremity; or 2. One or more major joints in each upper extremity resulting in an inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete work-related activities involving fine and gross movements. OR B. Inflammation or deformity in one or more major joints of an upper or lower extremity(ies) with: * * * * * * * * * * * Part B * * 101.00 * * Musculoskeletal Disorders. * * * 101.00 Musculoskeletal Disorders A. Which disorders do we evaluate under these listings? E:\FR\FM\07MYP3.SGM 07MYP3 20666 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules 1. We evaluate disorders of the skeletal spine (vertebral column) or of the upper or lower extremities that affect musculoskeletal functioning in the musculoskeletal body system listings. We use the term ‘‘skeletal’’ when we are referring to the structure of the bony skeleton. The skeletal spine refers to the bony structures, ligaments, and discs making up the spine. We refer to the ‘‘skeletal’’ spine in some musculoskeletal listings to differentiate it from the neurological spine (see 101.00B1). Disorders may be congenital or acquired, and may include deformities, amputations, or other musculoskeletal abnormalities. These disorders may involve the bones or major joints; or the tendons, ligaments, muscles, or other soft tissues. 2. We also evaluate soft tissue abnormalities or injuries (including burns) that are under continuing surgical management (see 101.00L). The abnormalities or injuries may affect any part of the body, including the face and skull. B. Which related disorders do we evaluate under other listings? 1. We evaluate a disorder or injury of the skeletal spine that results in damage to, and neurological dysfunction of, the spinal cord and its associated nerves (for example, paraplegia or quadriplegia) under the criteria in 111.00 Neurological Disorders. 2. We evaluate inflammatory arthritis (for example, rheumatoid arthritis) under the criteria in 114.00 Immune System Disorders. 3. We evaluate curvatures of the skeletal spine under these musculoskeletal disorders listings and other listings as appropriate for the affected body system. Curvatures of the skeletal spine that affect musculoskeletal functioning are evaluated under 101.15 Disorders of the skeletal spine resulting in compromise of a nerve root(s). If a curvature of the skeletal spine is under continuing surgical management, we can evaluate it for medical equivalence to 101.21 Soft tissue injury or abnormality under continuing surgical management. Skeletal curvatures may also adversely affect functioning in body systems other than the musculoskeletal system. For example, the curvature may interfere with your ability to breathe (see 103.00 Respiratory Disorders); there may be impaired myocardial function (see 104.00 Cardiovascular System); or there may be disfigurement resulting in social withdrawal or depression (see 112.00 Mental Disorders). 4. We evaluate non-healing or pathological fractures due to cancer, whether it is a primary site or metastases, under the criteria in 113.00 Cancer (Malignant Neoplastic Diseases). 5. We evaluate the leg pain associated with peripheral vascular claudication under the criteria in 104.00 Cardiovascular System. 6. We evaluate burns that do not require continuing surgical management under the criteria in 108.00 Skin Disorders. C. What evidence do we need to evaluate your musculoskeletal disorder under these listings? 1. General. To establish the presence of a musculoskeletal disorder as a medically determinable impairment, we need objective medical evidence from an acceptable medical source who has examined you for the disorder. To assess the severity and duration of your disorder, we evaluate evidence from both medical and nonmedical sources who can describe how you function. If there is no record of ongoing medical treatment for your disorder, we will follow the guidelines in 101.00Q How do we evaluate the severity and duration of your established musculoskeletal disorder when there is no record of ongoing treatment? We will determine the extent and kinds of evidence we need from medical and non-medical sources based on the individual facts about your disorder. For our basic rules on evidence, see §§ 416.902, 416.912, 416.913, 416.913a, and 416.920b of this chapter. For our rules on evidence about your symptoms, see § 416.929 of this chapter. 2. Physical examination report(s). In the report(s) of your physical examination, we need a detailed description of the orthopedic, neurologic, or other objective clinical findings appropriate to your specific musculoskeletal disorder. We require objective clinical findings from the medical source’s direct observations during your physical examination, not simply his or her report of your statements about your symptoms and limitations. When the medical source reports that a clinical test sign(s) is positive, unless we have evidence to the contrary, we will assume that he or she performed the test properly. For instance, we will assume a straight-leg raising test was conducted properly, i.e., in a sitting and supine position, even if the medical source does not specify the positions in which the test was performed. In the absence of evidence to the contrary, we will accept the medical source’s interpretation of the test. If you use an assistive device (see 101.00C6), the report must support the medical need for the device. If reduction in muscle strength is a factor, we require medical documentation of measurement of the strength of the muscle(s) in question, generally based on a grading system of 0 to 5. Zero (0) indicates complete loss of strength and 5 indicates maximum strength, consistent with Table 1 below. The documentation should also include measurements of grip and pinch strength, if there is evidence of involvement of one or both hands. TABLE 1 Grading Scale of Muscle Function: 0 to 5 daltland on DSKBBV9HB2PROD with PROPOSALS3 0 1 2 3 4 5 ...................................................... ...................................................... ...................................................... ...................................................... ...................................................... ...................................................... None .............................................. Trace .............................................. Poor ............................................... Fair ................................................. Good .............................................. Normal ........................................... 3. Laboratory findings: Imaging and other diagnostic tests a. Imaging refers to medical imaging techniques, such as x-ray, computed tomography (CT), magnetic resonance imaging (MRI), and radionuclide scanning. For the purpose of these listings, the imaging technique(s) must be consistent with the generally accepted standards of medical knowledge and clinical practice. b. Findings on imaging must have lasted, or must be expected to last, for a continuous period of at least 12 months. c. Imaging and other diagnostic tests can provide evidence of physical abnormalities; however, they may correlate poorly with your symptoms, including pain, or with your musculoskeletal functioning. Accordingly, we cannot use such tests as a substitute for physical examination findings about your VerDate Sep<11>2014 21:10 May 04, 2018 Jkt 244001 No visible or palpable contraction. Visible or palpable contraction with no motion. Active range of motion (ROM) with gravity eliminated. Active ROM against gravity only, without resistance. Active ROM against gravity, moderate resistance. Active ROM against gravity, maximum resistance. ability to function, nor can we infer severity or functional limitations based solely on such tests. d. For our policies about when we will purchase imaging and other diagnostic tests, see §§ 416.919k and 416.919m of this chapter. 4. Operative reports. If you have had a surgical procedure(s), we need either the operative reports, including details of the findings at surgery and information about any medical complications that may have occurred, or confirmatory evidence of the surgical procedure(s) from a medical source (for example, detailed follow-up reports or notations in the medical records concerning your past medical history). 5. Effects of treatment a. General. Treatments for musculoskeletal disorders may have beneficial or adverse PO 00000 Frm 00022 Fmt 4701 Sfmt 4702 effects, and responses to treatment vary from person to person. We will evaluate all of the effects of treatment (including surgical treatment, medications, and therapy) on the symptoms, signs, and laboratory findings of your musculoskeletal disorder, and on your musculoskeletal functioning. b. Response to treatment. To evaluate your musculoskeletal functioning in response to treatment, we need specific information related to your impairment, including the following: A description of your medications, including frequency of administration; the type and frequency of therapy you receive; and a description of your response to treatment and any complications you experience related to your impairment. The effects of treatment may be temporary or long-term. We need information over a sufficient period to determine the effect of E:\FR\FM\07MYP3.SGM 07MYP3 daltland on DSKBBV9HB2PROD with PROPOSALS3 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules treatment on your current musculoskeletal functioning and to permit reasonable projections about your future functioning. In some cases, we will need additional evidence to make an assessment about your response to treatment. Depending upon the timing of this treatment in relation to the alleged onset date of disability, we may need to defer evaluation of the impairment for a period of up to 3 months from the date treatment began to permit consideration of treatment effects, unless we can make a determination or decision using the evidence we have. 6. Assistive devices a. General. An assistive device, for the purposes of these listings, is any device that is used to improve stability, dexterity, or mobility. An assistive device can be worn (see 101.00C6b and c), or hand-held (see 101.00C6d). If you use any type of assistive device(s), we need evidence from a medical source regarding the documented medical need for the device(s). When we use the term ‘‘documented medical need,’’ we mean that there is evidence from a medical source(s) in the medical record that supports your need for an assistive device (see § 416.913 of this chapter). The evidence must include documentation from a medical source(s) describing any limitation(s) in your upper or lower extremity functioning that supports your need for the assistive device, and supporting the circumstances for which you need it. The evidence does not have to include a specific prescription for the device. b. Prosthesis(es). A prosthesis is a wearable device, such as an artificial limb, that takes the place of an absent body part. We need evidence from a medical source documenting your ability to walk, or to perform fine and gross movements (see 101.00E4), with the prosthesis(es) in place. When amputation(s) involves a lower extremity or extremities, it is not necessary to evaluate your ability to walk without the prosthesis(es) in place. If you cannot use your prosthesis(es) due to complications affecting your residual limb(s), we need documentation from a medical source regarding the condition of your residual limb(s) and the medical basis for your inability to use the prosthesis(es). c. Orthosis(es). An orthosis is a wearable device that prevents or corrects a dysfunction or deformity by aligning or supporting the affected body part. An orthosis may also be referred to as a ‘‘brace.’’ If you have an orthosis(es), we need evidence from a medical source documenting your ability to walk, or to perform fine and gross movements, with the orthosis(es) in place. If you cannot use your orthosis(es), we need evidence from a medical source documenting the medical basis for your inability to use the device(s). d. Hand-held assistive devices. Hand-held assistive devices include canes, crutches, or walkers, and are carried in your hand(s) to support or aid you in walking. When you require a one-handed assistive device for ambulation, such as a cane or single crutch, and your other upper extremity has limitations preventing its use for fine or gross movement(s) (see 101.00E4), the need for the assistive device limits the use of both upper extremities. If you use a hand-held assistive device, we need evidence from a medical VerDate Sep<11>2014 21:10 May 04, 2018 Jkt 244001 source documenting your need for the device(s) and describing how you walk with the device(s). 7. Longitudinal evidence a. We generally need a longitudinal medical record to assess the duration of your musculoskeletal disorder, because symptoms, signs, and laboratory findings related to most musculoskeletal disorders may wax and wane, may improve over time, or may respond to treatment. By providing evidence over an extended period, the medical record will show whether your musculoskeletal functioning is improving, worsening, or unchanging. b. For 101.19 Pathologic fractures due to any cause and 101.21 Soft tissue injury or abnormality under continuing surgical management, the required 12-month duration period is stated in the listing itself. For 101.20A (amputation of both upper extremities) or 101.20B (hemipelvectomy or hip disarticulation), we presume satisfaction of the duration requirement. c. For all listings not referenced in 101.00C7b above, all of the required criteria must be present simultaneously, or within a close proximity of time, to satisfy the level of severity needed to meet the listing. When we use the term ‘‘close proximity of time,’’ we mean that all of the relevant criteria have to appear in the medical record within a period not to exceed 4 months of one another. When the criterion in question is imaging, we mean those findings on imaging that we could reasonably expect to have been present at the date of impairment or date of onset. To meet a listing that uses the word ‘‘and’’ or ‘‘AND’’ to link the elements of the required criteria, the medical record must establish the simultaneous presence, or presence within a close proximity of time, of all the required medical criteria. Once this level of severity is established, the medical record must also show that this level of severity has continued, or is expected to continue, for a continuous period of at least 12 months. 8. Surgical treatment For some musculoskeletal disorders, a medical source may recommend surgery. If you have not yet had the recommended surgery, we will not deny your claim based on an assumption that surgery will resolve or improve your disorder. We will assess each case on an individual basis. Depending on your response to treatment, or depending on your medical sources’ treatment plans, we may defer our findings regarding the effect of surgical intervention until a sufficient period has passed to permit proper consideration or judgment about your future functioning. See 101.00C5b Response to treatment. D. How do we consider symptoms, including pain, under these listings? 1. Individuals with musculoskeletal disorders may experience pain or other symptoms; however, statements alone about your pain or other symptoms cannot establish that you are disabled. Further, an alleged or reported increase in the intensity of a symptom, such as pain, no matter how severe, cannot be substituted for a medical sign or diagnostic finding present in the listing criteria. Pain is included as just one consideration in paragraph A in listings PO 00000 Frm 00023 Fmt 4701 Sfmt 4702 20667 101.15, 101.16, and 101.18, but is not required to satisfy the criteria in these listings. Examples of other findings that will satisfy the criteria in paragraph A include muscle fatigue, nonradicular distribution of sensory loss in one or both extremities, and joint stiffness. 2. To consider your pain, we require objective medical evidence from an acceptable medical source showing the existence of a medically determinable impairment(s) (MDI) that could reasonably be expected to produce the pain. When your musculoskeletal MDI could reasonably be expected to produce the pain or other symptoms alleged, we consider all your symptoms, including pain, and the extent to which your symptoms can reasonably be accepted as consistent with all of the objective medical evidence, including medical signs and laboratory or diagnostic findings. See § 416.929 of this chapter for information on how we evaluate pain or other symptoms related to a musculoskeletal impairment. E. How do we use the functional criteria under these listings? 1. General. We will determine that your musculoskeletal disorder meets a listing if it satisfies the medical criteria; includes at least one of the functional criteria, if included in the listing; and satisfies the 12-month duration requirement. We will use the relevant evidence that we have to compare your musculoskeletal functioning to the functioning of children your age who do not have impairments. For example, if you are able to walk at home without an assistive device, we will not consider that to be conclusive evidence that you have similar functioning to other children your age who do not have impairments. 2. Medical and functional criteria, birth to attainment of age 3. The medical and functional criteria for children in this age group are in 101.24 Musculoskeletal disorders of infants and toddlers, from birth to attainment of age 3, with developmental motor delay. 3. Functional criteria, age 3 to attainment of age 18. The functional criteria are based on impairment-related physical limitations in your ability to use both upper extremities, one or both lower extremities, or a combination of one upper and one lower extremity. A musculoskeletal disorder satisfies the functional criteria of a listing when the medical documentation shows the presence of at least one of the impairmentrelated limitations cited in the listing. The functional criteria require impairment-related physical limitation of musculoskeletal functioning that has lasted, or can be expected to last, for a continuous period of at least 12 months, medically documented by one of the following: a. A documented medical need (see 101.00C6a) for a walker, bilateral canes, or bilateral crutches (see 101.00C6d); b. An inability to use one upper extremity to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements (see 101.00E4), and a documented medical need (see 101.00C6a) for a one-handed assistive device (see 101.00C6d) that requires the use of your other upper extremity; E:\FR\FM\07MYP3.SGM 07MYP3 daltland on DSKBBV9HB2PROD with PROPOSALS3 20668 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules c. An inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements (see 101.00E4). 4. Fine and gross movements. Fine movements, for the purposes of these listings, involve use of your wrists, hands, and fingers; such movements include picking, pinching, manipulating, and fingering. Gross movements involve use of your shoulders, upper arms, forearms, and hands; such movements include handling, gripping, grasping, holding, turning, and reaching. Gross movements also include exertional abilities such as lifting, carrying, pushing, and pulling. 5. When we do not use the functional criteria. We do not use the functional criteria to evaluate amputation of both upper extremities under 101.20A, hemipelvectomy or hip disarticulation under 101.20B, and soft tissue injuries or abnormalities under continuing surgical management under 101.21. F. What do we consider when we evaluate disorders of the skeletal spine resulting in compromise of a nerve root(s) (101.15)? 1. General. We consider musculoskeletal disorders such as skeletal dysplasias, caudal regression syndrome, tethered spinal cord syndrome, vertebral slippage (spondylolisthesis), scoliosis, and vertebral fracture or dislocation. Spinal disorders may cause cervical or lumbar spine dysfunction when abnormalities of the skeletal spine compromise nerve roots of the cervical spine, a nerve root of the lumbar spine, or a nerve root of both cervical and lumbar spines. 2. Compromise of a nerve root(s). Compromise of a nerve root(s), sometimes referred to as ‘‘nerve root impingement,’’ is a term used when a physical object is seen pushing on the nerve root in an imaging study or during surgery. Objects such as tumors, herniated discs, foreign bodies, or arthritic spurs may cause compromise of a nerve root. It can occur when a musculoskeletal disorder produces irritation, inflammation, or compression of the nerve root(s) as it exits the skeletal spine between the vertebrae. Related symptoms must be associated with, or follow the path of, the specific nerve root(s), thereby presenting a neuro-anatomic (usually referred to as ‘‘radicular’’) distribution of symptoms and signs, including pain, paresthesia (for example, burning, prickling, or tingling), sensory loss, and usually muscle weakness specific to the affected nerve root(s). a. Compromise of unilateral nerve root of the cervical spine. Compromise of a nerve root as it exits the cervical spine between the vertebrae may affect the functioning of the associated upper extremity. The clinical examination reproduces the related symptoms based on radicular signs and clinical tests (for example, a positive Spurling’s Test) appropriate to the specific cervical nerve root. b. Compromise of bilateral nerve roots of the cervical spine. Although uncommon, if compromise of a nerve root occurs on both sides of the cervical spinal column, functioning of both upper extremities may be limited. VerDate Sep<11>2014 21:10 May 04, 2018 Jkt 244001 c. Compromise of a nerve root(s) of the lumbar spine. Compromise of a nerve root as it exits the lumbar spine between the vertebrae may limit the functioning of the associated lower extremity. The clinical examination reproduces the related symptoms based on radicular signs and clinical tests. When a nerve root of the lumbar spine is compromised, we require a positive straight-leg raising test (also known as a Lasegue test) in both supine and sitting positions appropriate to the specific lumbar nerve root that is compromised. (See 101.00C2 for guidance on interpreting information from a physical examination report.) G. What do we consider when we evaluate lumbar spinal stenosis resulting in compromise of the cauda equina (101.16)? 1. We consider the limiting effects of pain, sensory changes, and muscle weakness caused by compromise of the cauda equina due to lumbar spinal stenosis. The cauda equina is a bundle of nerve roots that descends from the lower part of the spinal cord. Lumbar spinal stenosis can compress the nerves of the cauda equina, causing sensory changes and muscle weakness that may affect your ability to stand or walk. Pain related to compromise of the cauda equina is ‘‘nonradicular,’’ because it is not typically associated with a specific nerve root (as is radicular pain in the cervical or lumbar spine). 2. Compromise of the cauda equina due to spinal stenosis can affect your ability to walk because of neurogenic claudication (also known as pseudoclaudication), a disorder usually causing non-radicular pain that starts in the low back and radiates bilaterally (or less commonly, unilaterally) into the buttocks and lower extremities (or extremity). Extension of the lumbar spine, as when walking or merely standing, provokes the pain of neurogenic claudication. It is relieved by forward flexion of the lumbar spine or by sitting. H. What do we consider when we evaluate reconstructive surgery or surgical arthrodesis of a major weight-bearing joint (101.17)? 1. We consider reconstructive surgery or surgical arthrodesis when an acceptable medical source(s) documents the surgical procedure(s) and associated medical treatments to restore function of the affected body part(s). The reconstructive surgery may be a single event or it may be a series of procedures directed toward the salvage or restoration of functional use of the affected joint. 2. Major weight-bearing joints. The major weight-bearing joints are the hip, knee, and ankle-foot. The ankle and foot are considered together as one major joint. 3. Surgical arthrodesis. Surgical arthrodesis is the artificial fusion of the bones that form a joint, essentially eliminating the joint. I. What do we consider when we evaluate abnormality of a major joint(s) in any extremity (101.18)? 1. General. We consider musculoskeletal disorders that produce anatomical abnormalities of major joints of the extremities, resulting in functional abnormalities in the upper or lower PO 00000 Frm 00024 Fmt 4701 Sfmt 4702 extremities (for example, infections of bones and joints). Major joint of an upper extremity refers to the shoulder, elbow, and wrist-hand. We consider the wrist and hand together as one major joint. Major joint of a lower extremity refers to the hip, knee, and anklefoot. We consider the ankle and hindfoot together as one major joint, because it is necessary for walking. Abnormalities affecting the joints may include ligamentous laxity or rupture, soft tissue contracture, or tendon rupture, and can cause muscle weakness of the affected body part. 2. How do we define abnormality in the extremities? An anatomical abnormality in any extremity(ies) is one that is readily observable by a medical source during a physical examination (for example, subluxation or contracture), or is present on imaging (for example, ankylosis, bony destruction, joint space narrowing, or deformity). A functional abnormality is abnormal motion or instability of the affected part(s), including limitation of motion, excessive motion (hypermobility), movement outside the normal plane of motion for the joint (for example, lateral deviation), or fixation of the affected parts. J. What do we consider when we evaluate pathologic fractures due to any cause (101.19)? We consider pathologic fractures of the bones in the skeletal spine, extremities, or other parts of the skeletal system. Pathologic fractures result from disorders that weaken the bones, making them vulnerable to breakage. For non-healing or complex traumatic fractures without accompanying pathology, see 101.22 Nonhealing or complex fracture of the femur, tibia, pelvis, or one or more of the tarsal bones, or 101.23 Non-healing fracture of an upper extremity. Pathologic fractures may occur with osteoporosis, osteogenesis imperfecta or any other skeletal dysplasias, side effects of medications, and disorders of the endocrine or other body systems. They must occur on separate, distinct occasions, rather than multiple fractures occurring at the same time, but they may affect the same bone(s) multiple times. There is no required period between the incidents of fracture(s), but they must all occur within a 12-month period; for example, separate incidents may occur within hours or days of each other. However, the associated limitation(s) of function must last, or be expected to last, at least 12 months. K. What do we consider when we evaluate amputation due to any cause (101.20)? 1. General. We consider amputations (the full or partial loss or absence of any extremity) due to any cause, including trauma, congenital abnormality or absence, or surgery for treatment of conditions such as cancer or infection. 2. Amputation of both upper extremities (101.20A). Upper extremity amputations, for the purposes of this listing, may occur at any level above the wrists (carpal joints), up to and including disarticulation of the shoulder (glenohumeral) joint. We do not evaluate amputations below the wrists under this listing, because the resulting limitation of function of the thumb(s), finger(s), or hand(s) will vary, depending on the extent of loss and corresponding effect on fine and gross E:\FR\FM\07MYP3.SGM 07MYP3 daltland on DSKBBV9HB2PROD with PROPOSALS3 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules movements (see 101.00E4). For amputations below the wrist, we will follow our rules for determining functional equivalence to the listings (see § 416.926a of this chapter). 3. Hemipelvectomy or hip disarticulation (101.20B). Hemipelvectomy involves amputation of an entire lower extremity through the sacroiliac joint. Hip disarticulation involves amputation of an entire lower extremity through the hip joint capsule and closure of the remaining musculature over the exposed acetabular bone. 4. Amputation of one upper extremity at any level above the wrist and one lower extremity at or above the ankle (101.20C). We evaluate the absence of one upper extremity and one lower extremity with regard to whether you have a documented medical need (see 101.00C6a) for a one-handed assistive device (see 101.00C6d), such as a cane or crutch. In this situation, you may wear a prosthesis (see 101.00C6b) on your lower extremity, but nevertheless have a documented medical need for a one-handed assistive device. If you do, you would need to use your other upper extremity to hold the assistive device, making the extremity unavailable to perform other fine and gross movements (see 101.00E4) such as carrying. In such a case, your disorder would meet this listing. 5. Amputation of one or both lower extremities at or above the ankle (tarsal joint), (101.20D). When we evaluate amputations of one or both lower extremities: a. We consider the condition of your residual limb(s), and whether you can wear a prosthesis(es) (see 101.00C6b). When you have a prosthesis(es), we will examine your residual limb with the prosthesis(es) in place. If you are unable to use a prosthesis(es) because of residual limb complications that have lasted, or are expected to last, for at least 12 months, and you are not currently undergoing surgical management (see 101.00L1) of your condition, we evaluate your disorder under this listing. b. Under 101.20D ‘‘Amputation of one or both lower extremities at or above the ankle (tarsal joint),’’ we consider whether you have a documented medical need (see 101.00C6a) for a hand-held assistive device(s) (see 101.00C6d) and your ability to walk with the device(s). c. If you have a non-healing residual limb(s) and are receiving ongoing surgical treatment expected to re-establish or improve function, and that ongoing surgical treatment has not ended, or is not expected to end, within at least 12 months of the initiation of the surgical management (see 101.00L1), we evaluate your disorder under 101.21 Soft tissue injury or abnormality under continuing surgical management. L. What do we consider when we evaluate soft tissue injury or abnormality under continuing surgical management (101.21)? 1. General. a. We consider any soft tissue injury or abnormality involving the soft tissues of the body, whether congenital or acquired, when an acceptable medical source(s) documents the need for ongoing surgical procedures and associated medical treatments to restore function of the affected body parts. Surgical VerDate Sep<11>2014 21:10 May 04, 2018 Jkt 244001 management includes the surgery(-ies) itself, as well as various post-surgical procedures, surgical complications, infections or other medical complications, related illnesses, or related treatments that delay a person’s attainment of maximum benefit from therapy. b. Surgical procedures and associated treatments typically take place over extended periods, which may render you unable to perform age-appropriate activity on a sustained basis. To document such inability, we must have evidence from an acceptable medical source(s) confirming that the surgical management has continued, or is expected to continue, for at least 12 months from the date of the first surgical intervention. These procedures and treatments must be directed toward saving, reconstructing, or replacing the affected part of the body to re-establish or improve its function, and not for cosmetic appearances alone. c. Examples include malformations, thirdand fourth-degree burns, crush injuries, craniofacial injuries, avulsive injuries, and amputations with complications of the residual limb(s). d. We evaluate skeletal spine abnormalities or injuries under 101.15 Disorders of the skeletal spine resulting in compromise of a nerve root(s) or 101.16 Lumbar spinal stenosis resulting in compromise of the cauda equina, as appropriate. We evaluate abnormalities or injuries of bones in the lower extremities under 101.17 Reconstructive surgery or surgical arthrodesis of a major weight-bearing joint, 101.18 Abnormality of a major joint(s) in any extremity, or 101.22 Non-healing fracture of the femur, tibia, pelvis, or one or more of the tarsal bones. We evaluate abnormalities or injuries of bones in the upper extremities under 101.18 Abnormality of a major joint(s) in any extremity, or 101.23 Non-healing or complex fracture of an upper extremity. 2. Documentation. In addition to the objective medical evidence we need to establish your soft tissue injury or abnormality, we also need all of the following medically documented evidence about your continuing surgical management: a. Operative reports and related laboratory findings; b. Records of post-surgical procedures; c. Records of any surgical or medical complications (for example, related infections or systemic illnesses); d. Records of any prolonged post-operative recovery periods and related treatments (for example, surgeries and treatments for burns); and e. An acceptable medical source’s plans for additional surgeries; f. Records detailing any other factors that have delayed, or that an acceptable medical source expects to delay, the saving, restoring, or replacing of the involved part for a continuous period of at least 12 months following the initiation of the surgical management. 3. Burns. Third- and fourth-degree burns damage or destroy nerve tissue, reducing or preventing transmission of signals through those nerves. Such burns frequently require multiple surgical procedures and related therapies to re-establish or improve function, PO 00000 Frm 00025 Fmt 4701 Sfmt 4702 20669 which we evaluate under 101.21 Soft tissue injury or abnormality under continuing surgical management. When burns are no longer under continuing surgical management, we evaluate the residual impairment(s) (see 101.00P). When the residual impairment(s) affects the musculoskeletal system, as often occurs in third and fourth degree burns, it can result in permanent musculoskeletal tissue loss, joint contractures, or loss of extremities. We will evaluate such impairments under the relevant musculoskeletal listing(s), for example, 101.18 Abnormality of a major joint(s) in any extremity or 101.20 Amputation due to any cause. When the residual impairment(s) involves another body system(s), we will evaluate the impairment(s) under the relevant body system listing (for example, 108.08 Burns). 4. Congenital abnormalities or craniofacial injuries. Surgeons may treat craniofacial injuries or abnormalities with multiple surgical procedures. These injuries or abnormalities may affect vision, hearing, speech, and the initiation of the digestive process, including mastication. When the craniofacial injury-related or congenital residual impairment(s) involves another body system(s), we will evaluate the impairment(s) under the relevant body system listings. See 101.00P regarding evaluation of residual impairment(s). M. What do we consider when we evaluate non-healing or complex fractures of the femur, tibia, pelvis, or one or more of the tarsal bones (101.22)? 1. We evaluate a non-healing (nonunion) or complex fracture of the femur, tibia, pelvis, or one or more of the tarsal bones with regard to whether you have a documented medical need (see 101.00C6a) for a bilateral (twohanded) assistive device (see 101.00C6d), such as a walker or bilateral crutches. 2. Non-healing fracture. A non-healing fracture is a fracture that has failed to unite completely. Nonunion is usually established when a minimum of 9 months has elapsed since the injury and the fracture site has shown no progressive signs of healing for a minimum of 3 months. 3. Complex fracture. A fracture is complex when one or more of the following occur: a. Comminuted (broken into many pieces) bone fragments, b. Multiple fractures in a single bone, c. Bone loss due to severe trauma, d. Damage to the surrounding soft tissue, e. Severe cartilage damage to the associated joint, or f. Dislocation of the associated joint. 4. When a complex fracture involves soft tissue damage, the treatment may involve continuing surgical management to restore or improve functioning. In such cases, we may evaluate the fracture(s) under 101.21 Soft tissue injury or abnormality under continuing surgical management. N. What do we consider when we evaluate non-healing or complex fractures of an upper extremity (101.23)? 1. We evaluate a non-healing (nonunion) or complex fracture of an upper extremity under continuing surgical management (see 101.00L1a) with regard to whether you have an inability to use both upper extremities to E:\FR\FM\07MYP3.SGM 07MYP3 daltland on DSKBBV9HB2PROD with PROPOSALS3 20670 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules independently initiate, sustain, and complete fine and gross movements. 2. Non-healing fracture. A non-healing fracture is a fracture that has failed to unite completely. Nonunion is usually established when a minimum of 9 months has elapsed since the injury and the fracture site has shown no progressive signs of healing for a minimum of 3 months. 3. Complex fracture. A fracture is complex when one or more of the following occur: a. Comminuted (broken into many pieces) bone fragments b. Multiple fractures in a single bone c. Bone loss due to severe trauma d. Damage to the surrounding soft tissue e. Severe cartilage damage to the associated joint f. Dislocation of the associated joint. O. What do we consider when we evaluate musculoskeletal disorders of infants and toddlers from birth to attainment of age 3 with developmental motor delay (101.24)? 1. Under listing 101.24 Musculoskeletal disorders of infants and toddlers, from birth to attainment of age 3, with developmental motor delay, we use reports from an acceptable medical source(s) to establish a diagnosis of delay in your motor development. To evaluate the severity level of your developmental motor delay, we accept developmental test reports from an acceptable medical source, or from early intervention specialists, physical and occupational therapists, and other sources. a. If there is a standardized developmental assessment in your medical record, we will use the results to evaluate your developmental motor delay under 101.24A. Such an assessment compares your level of development to the level typically expected for children of your chronological age. If you were born prematurely, we use your corrected chronological age (CCA) for comparison. Your CCA is your chronological age adjusted by a period of gestational prematurity (CCA = (chronological age)— (number of weeks premature)) (see § 416.924b(b) of this chapter). b. If there is no standardized developmental assessment in your medical record, we will use narrative developmental reports from a medical source(s) to evaluate your developmental motor delay under 101.24B. These reports must provide detailed information sufficient for us to assess the severity of your motor delay. If we cannot obtain sufficient detail from narrative reports, we may purchase standardized developmental assessments. (i) A narrative developmental report is based on clinical observations, progress notes, and well-baby check-ups, and must include your developmental history; examination findings (with abnormal findings noted on repeated examinations); and an overall assessment of your development (that is, more than one or two isolated skills) by the medical source. (ii) Some narrative developmental reports may include results from developmental screening tests, which can show that you are not developing or achieving skills within expected timeframes. Although medical sources may refer to screening test results as supporting evidence in the narrative VerDate Sep<11>2014 21:10 May 04, 2018 Jkt 244001 developmental report, screening test results alone cannot establish a medically determinable impairment or the severity of developmental motor delay. 2. Examples of disorders we evaluate include arthrogryposis, clubfoot, osteogenesis imperfecta, caudal regression syndrome, fracture complications, disorders affecting the hip and pelvis, and complications associated with your disorder or its treatment. Some medical records may simply document your condition as ‘‘developmental motor delay.’’ P. How do we determine when your soft tissue injury or abnormality or your upper extremity fracture is no longer under continuing surgical management or you have received maximum therapeutic benefit? 1. Your soft tissue injury or abnormality or your upper extremity fracture is no longer under continuing surgical management when the last surgical procedure or medical treatment directed toward the reestablishment or improvement of function of the involved part has occurred. We will find that you have received maximum therapeutic benefit from treatment if there are no significant changes in physical findings or on appropriate imaging for any 6-month period after the last surgical procedure or medical treatment. We may also find that you have received maximum therapeutic benefit if your medical source(s) indicates that further improvement is not expected after the last surgical procedure or medical treatment. 2. When you have received maximum therapeutic benefit from treatment, we will evaluate any impairment-related residual symptoms, signs, and laboratory findings (including those on imaging), any complications associated with your surgical procedures or medical treatments, and any residual limitations in your functioning. Depending upon all of those factors, we may find that your musculoskeletal impairment is no longer severe. 3. If your impairment(s) remains severe, we will evaluate your residual limitations and all other impairment-related factors to determine whether your musculoskeletal disorder meets or medically equals another listing or functionally equals the listings. If your impairment involves burns and remains severe, we will follow the above sequence by evaluating your impairment as described in 101.00L3. Q. How do we evaluate the severity and duration of your established musculoskeletal disorder when there is no record of ongoing treatment? 1. You may not have received ongoing treatment or may not have an ongoing relationship with the medical community despite having a musculoskeletal disorder(s). In either of these situations, you will not have a longitudinal medical record for us to review when we evaluate your disorder. We may therefore ask you to attend a consultative examination to determine the severity and potential duration of your disorder (see § 416.919a(b) of this chapter). 2. In some instances, we may be able to assess the severity and duration of your musculoskeletal disorder based on your medical record and current evidence alone. If the information in your case record is not PO 00000 Frm 00026 Fmt 4701 Sfmt 4702 sufficient or appropriate to show that you have a musculoskeletal disorder that meets the criteria of one of the musculoskeletal disorders listings, we will follow the rules in 101.00R. R. How do we evaluate disorders that do not meet one of the musculoskeletal listings? 1. These listings are only examples of musculoskeletal disorders that we consider severe enough to result in marked and severe functional limitations. If your musculoskeletal disorder(s) does not meet the criteria of any of these listings, we will consider whether you have an impairment(s) that meets the criteria of a listing in another body system. 2. If you have a severe medically determinable impairment(s) that does not meet any listing, we will determine whether your impairment(s) medically equals a listing (see § 416.926 of this chapter). If it does not medically equal a listing, we will determine whether it functionally equals the listings (see § 416.926a of this chapter). 3. We use the rules in § 416.994a of this chapter when we decide whether you continue to be disabled. 101.01 Category of Impairments, Musculoskeletal Disorders 101.15 Disorders of the skeletal spine resulting in compromise of a nerve root(s) (see 101.00F), documented by A, B, C, and D: A. Symptom(s) of neuro-anatomic (radicular) distribution of one or more of the following manifestations consistent with compromise of the affected nerve root(s): 1. Pain; or 2. Paresthesias; or 3. Muscle fatigue. AND B. Radicular neurological signs present during physical examination or testing and evidenced by 1, 2, and 4; or 1, 3, and 4 below: 1. Muscle weakness; and 2. Sensory changes evidenced by: a. Decreased sensation; or b. Sensory nerve deficit (abnormal sensory nerve latency) on electrodiagnostic testing; or 3. Decreased deep tendon reflexes; and 4. Sign(s) of nerve root irritation, tension, or compression, consistent with compromise of the affected nerve root (see 101.00F2). AND C. Findings on imaging consistent with compromise of a nerve root(s) in the cervical or lumbosacral spine (see 101.00C3). AND D. Impairment-related physical limitation of musculoskeletal functioning that has lasted, or can be expected to last, for a continuous period of at least 12 months, and medical documentation of at least one of the following (see 101.00E): 1. A documented medical need for a walker, bilateral canes, or bilateral crutches; or 2. An inability to use one upper extremity to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements, and a documented medical need for a one-handed assistive device that requires the use of the other upper extremity; or E:\FR\FM\07MYP3.SGM 07MYP3 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules daltland on DSKBBV9HB2PROD with PROPOSALS3 3. An inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements. 101.16 Lumbar spinal stenosis resulting in compromise of the cauda equina (see 101.00G), documented by A, B, C, and D: A. Symptoms of neurological compromise, such as pain, manifested as: 1. Nonradicular distribution of pain in one or both lower extremities; or 2. Nonradicular distribution of sensory loss in one or both extremities; or 3. Neurogenic claudication. AND B. Nonradicular neurological signs present during physical examination or testing and evidenced by 1 and 2, or 1 and 3, below: 1. Muscle weakness; and 2. Sensory changes evidenced by: a. Decreased sensation; or b. Sensory nerve deficit (abnormal sensory nerve latency) on electrodiagnostic testing; or c. Areflexia, trophic ulceration, or bladder or bowel incontinence. 3. Decreased deep tendon reflexes in one or both lower extremities. AND C. Findings on imaging or in an operative report consistent with compromise of the cauda equina with lumbar spinal stenosis. AND D. Impairment-related physical limitation of musculoskeletal functioning that has lasted, or can be expected to last, for a continuous period of at least 12 months, and medical documentation of at least one of the following (see 101.00E): 1. A documented medical need for a walker, bilateral canes, or bilateral crutches; or 2. An inability to use one upper extremity to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements, and a documented medical need for a one-handed assistive device that requires the use of the other upper extremity. 101.17 Reconstructive surgery or surgical arthrodesis of a major weight-bearing joint (see 101.00H), documented by A and B and C: A. Documented history of reconstructive surgery or surgical arthrodesis of a major weight-bearing joint. AND B. Impairment-related physical limitation of musculoskeletal functioning that has lasted, or can be expected to last, for a continuous period of at least 12 months. AND C. A documented medical need for a walker, bilateral canes, or bilateral crutches (see 101.00E). 101.18 Abnormality of a major joint(s) in any extremity (see 101.00I), documented by A, B, C, and D: A. Chronic joint pain or stiffness. AND B. Abnormal motion, instability, or immobility of the affected joint(s). AND VerDate Sep<11>2014 21:10 May 04, 2018 Jkt 244001 C. Anatomical abnormality of the affected joint(s) noted on: 1. Physical examination (for example, subluxation, contracture, bony or fibrous ankylosis); or 2. Imaging (for example, joint space narrowing, bony destruction, or ankylosis or arthrodesis of the affected joint). AND D. Impairment-related physical limitation of musculoskeletal functioning that has lasted, or can be expected to last, for a continuous period of at least 12 months, and medical documentation of at least one of the following (see 101.00E): 1. A documented medical need for a walker, bilateral canes, or bilateral crutches; or 2. An inability to use one upper extremity to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements, and a documented medical need for a one-handed assistive device that requires the use of the other upper extremity; or 3. An inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements. 101.19 Pathologic fractures due to any cause (see 101.00J), documented by A and B: A. Three or more medically documented pathologic fractures occurring on separate occasions within a 12-month period; AND B. Impairment-related physical limitation of musculoskeletal functioning that has lasted, or can be expected to last, for a continuous period of at least 12 months, and medical documentation of at least one of the following (see 101.00E): 1. A documented medical need for a walker, bilateral canes, or bilateral crutches; or 2. An inability to use one upper extremity to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements, and a documented medical need for a one-handed assistive device that requires the use of the other upper extremity; or 3. An inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements. 101.20 Amputation due to any cause (see 101.00K), documented by A, B, C, or D: A. Amputation of both upper extremities, occurring at any level above the wrists (carpal joints), up to and including the shoulder (glenohumeral) joint. OR B. Hemipelvectomy or hip disarticulation. OR C. Amputation of one upper extremity, occurring at any level above the wrist (carpal joints), and one lower extremity at or above the ankle (tarsal joint), and medical documentation of one the following (see 101.00E): 1. The documented medical need for a onehanded assistive device requiring the use of the other upper extremity, or PO 00000 Frm 00027 Fmt 4701 Sfmt 4702 20671 2. The inability to use the remaining upper extremity to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements. OR D. Amputation of one or both lower extremities at or above the ankle (tarsal joint), with complications of the residual limb that have lasted or can be expected to last for at least 12 months, and medical documentation of both 1 and 2 (see 101.00E): 1. The inability to use a prosthetic device(s); and 2. The documented medical need for a walker, bilateral canes, or bilateral crutches. 101.21 Soft tissue injury or abnormality under continuing surgical management (see 101.00L), documented by A, B, and C in the medical record: A. Evidence confirms ongoing surgical management directed towards saving, reconstructing, or replacing the affected part of the body. AND B. The surgical management has been, or is expected to be, ongoing for at least 12 months. AND C. Maximum benefit from therapy has not yet been achieved. 101.22 Non-healing or complex fracture of the femur, tibia, pelvis, or one or more of the tarsal bones (see 101.00M), documented by A and B and C: A. Solid union not evident on appropriate medically acceptable imaging and not clinically solid; AND B. Impairment-related physical limitation of musculoskeletal functioning that has lasted, or can be expected to last, for a continuous period of at least 12 months, AND C. A documented medical need for a walker, bilateral canes, or bilateral crutches (see 101.00E). 101.23 Non-healing or complex fracture of an upper extremity (see 101.00N), Documented by A and B and C: A. Nonunion of a fracture, or complex fracture, of the shaft of the humerus, radius, or ulna, under continuing surgical management, as defined in 1.00P, directed toward restoration of functional use of the extremity; AND B. Impairment-related physical limitation of musculoskeletal functioning that has lasted, or can be expected to last, for a continuous period of at least 12 months, AND C. Medical documentation of at least one of the following (see 101.00E): 1. An inability to use one upper extremity to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements, and a documented medical need for a one-handed assistive device that requires the use of the other upper extremity; or 2. An inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and E:\FR\FM\07MYP3.SGM 07MYP3 20672 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules complete age-appropriate activities involving fine and gross movements. 101.24 Musculoskeletal disorders of infants and toddlers, from birth to attainment of age 3, with developmental motor delay (see 101.00O), as documented by A or B: A. A standardized developmental motor assessment that: 1. Shows motor development not more than one-half the level typically expected for child’s age; or 2. Results in a valid score that is at least three standard deviations below the mean. OR B. Two narrative developmental reports that: 1. Are dated at least 120 days apart; and 2. Show motor development not more than one-half of the level typically expected for child’s age. from a squatting or sitting position or to climb stairs may be an indication that you are unable to walk without physical or mechanical assistance. * * * * * * * * 6. Inflammatory arthritis (114.09). a. General. * * * Clinically, inflammation of major joints in an upper or lower extremity may be the dominant manifestation causing difficulties with walking or performing fine and gross movements; there may be joint pain, swelling, and tenderness. The arthritis may affect other joints, or cause less limitation in walking or performing fine and gross movements. * * * * * * * * 5. Documented medical need has the same meaning as in 101.00C6a. e. How we evaluate inflammatory arthritis under the listings. (i) Listing-level severity in 114.09 Inflammatory arthritis A and C1 is shown by the presence of an impairment-related, significant limitation cited in the criteria of these listings. In 114.09A, listing-level severity is satisfied with persistent inflammation or deformity in one major joint in a lower extremity resulting in a documented medical need for a walker, bilateral canes, or bilateral crutches as required in 114.09A1, or one major joint in each upper extremity resulting in an impairment-related, significant limitation in the ability to perform fine and gross movements as required in 114.09A2. In 114.09C1, if you have the required ankylosis (fixation) of your cervical or dorsolumbar spine, we will find that you have an impairment-related significant limitation in your ability to see in front of you, above you, and to the side. Therefore, a listing-level impairment in the ability to walk is implicit in 114.09C1, even though you might not require bilateral upper limb assistance. (ii) Listing-level severity is shown in 114.09B and 114.09C2 by inflammatory arthritis that involves various combinations of complications of one or more major joints in an upper or lower extremity or other joints, such as inflammation or deformity, extra-articular features, repeated manifestations, and constitutional symptoms and signs. * * * * * * * 104.00 * * * * * CARDIOVASCULAR SYSTEM * * * F. Evaluating Other Cardiovascular Impairments * * * * * 9. What is lymphedema and how will we evaluate it? * * * * * b. * * * We will evaluate lymphedema by considering whether the underlying cause meets or medically equals any listing or whether the lymphedema medically equals a cardiovascular listing, such as 4.11 Chronic venous insufficiency, or a musculoskeletal listing, such as 101.18 Abnormality of a major joint(s) in any extremity. * * * * * 114.00 * * * * * IMMUNE SYSTEM DISORDERS * * * * * C. Definitions * * * 2. Assistive device(s) has the same meaning as in 101.00C6a. * * * * * * * * * 8. Fine and gross movements have the same meaning as in 101.00E4. 9. Hand-held assistive device has the same meaning as in 101.00C6d. 10. Major joint of an upper or lower extremity has the same meaning as in 101.00I1. * * * * * D. How do we document and evaluate the listed autoimmune disorders? * * * * * daltland on DSKBBV9HB2PROD with PROPOSALS3 4. Polymyositis and dermatomyositis (114.05). * * * * * c. Additional information about how we evaluate polymyositis and dermatomyositis under the listings. * * * * * (ii) If you are of preschool age through adolescence (age 3 to attainment of age 18), weakness of your pelvic girdle muscles that results in your inability to rise independently VerDate Sep<11>2014 21:10 May 04, 2018 Jkt 244001 * * * * 114.01 Category of Impairments, Immune System Disorders * * * * * 114.04 Systemic sclerosis (scleroderma). As described in 114.00D3. With: * * * * * B. One of the following: 1. Toe contractures or fixed deformity of one or both feet, resulting in one of the following: a. A documented medical need for a walker, bilateral canes, or bilateral crutches (see 114.00C9); or b. An inability to use one upper extremity to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements, and a documented medical need for a one-handed assistive device (see 114.00C9) that requires the use of the other upper extremity; or 2. Finger contractures or fixed deformity in both hands, resulting in an inability to use PO 00000 Frm 00028 Fmt 4701 Sfmt 4702 both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements; or 3. Atrophy with irreversible damage in one or both lower extremities, resulting in one of the following: a. A documented medical need for a walker, bilateral canes, or bilateral crutches (see 114.00C9); or b. An inability to use one upper extremity to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements, and a documented medical need for a one-handed assistive device (see 114.00C9) that requires the use of the other upper extremity; or 4. Atrophy with irreversible damage in both upper extremities, resulting in an inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements. OR C. Raynaud’s phenomenon, characterized by: * * * * * 2. Ischemia with ulcerations of toes or fingers, resulting in one of the following: a. A documented medical need for a walker, bilateral canes, or bilateral crutches (see 114.00C9); or b. An inability to use one upper extremity to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements, and a documented medical need for a one-handed assistive device (see 114.00C9) that requires the use of the other upper extremity; or c. An inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements. * * * * * 114.05 Polymyositis and dermatomyositis. As described in 114.00D4. With: A. Proximal limb-girdle (pelvic or shoulder) muscle weakness, resulting in one of the following: 1. A documented medical need for a walker, bilateral canes, or bilateral crutches (see 114.00C9); or 2. An inability to use one upper extremity to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements, and a documented medical need for a one-handed assistive device (see 114.00C9) that requires the use of the other upper extremity; or 3. An inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements. * * * * * 114.09 Inflammatory arthritis. As described in 114.00D6. With: A. Persistent inflammation or persistent deformity of: 1. One or more major joints in a lower extremity(ies) resulting in one of the following: E:\FR\FM\07MYP3.SGM 07MYP3 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules daltland on DSKBBV9HB2PROD with PROPOSALS3 a. A documented medical need for a walker, bilateral canes, or bilateral crutches (see 114.00C9); or b. An inability to use one upper extremity to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements, and a documented medical need for a one-handed assistive device (see 114.00C9) that requires the use of the other upper extremity; or 2. One or more major joints in each upper extremity resulting in an inability to use both upper extremities to the extent that neither can be used to independently initiate, sustain, and complete age-appropriate activities involving fine and gross movements. VerDate Sep<11>2014 21:10 May 04, 2018 Jkt 244001 OR B. Inflammation or deformity in one or more major joints of an upper or lower extremity(ies) with: * * * * * * * * PART 416—SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED Subpart I—[Amended] 3. The authority citation for subpart I of part 416 continues to read as follows: ■ PO 00000 Authority: Secs. 221(m), 702(a)(5), 1611, 1614, 1619, 1631(a), (c), (d)(1), and (p), and 1633 of the Social Security Act (42 U.S.C. 421(m), 902(a)(5), 1382, 1382c, 1382h, 1383(a), (c), (d)(1), and (p), and 1383b); secs. 4(c) and 5, 6(c)-(e), 14(a), and 15, Pub. L. 98– 460, 98 Stat. 1794, 1801, 1802, and 1808 (42 U.S.C. 421 note, 423 note, and 1382h note). 4. Amend § 416.926a by removing paragraph (m)(1) through (m)(2) and redesignating paragraphs (m)(3) through (m)(5) as (m)(1) through (m)(3). ■ [FR Doc. 2018–08889 Filed 5–4–18; 8:45 am] BILLING CODE 4191–02–P Frm 00029 Fmt 4701 Sfmt 9990 20673 E:\FR\FM\07MYP3.SGM 07MYP3

Agencies

Social Security Administration

[Federal Register Volume 83, Number 88 (Monday, May 7, 2018)]
[Proposed Rules]
[Pages 20646-20673]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-08889]

[[Page 20645]]

Vol. 83

Monday,

No. 88

May 7, 2018

Part III

Social Security Administration

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20 CFR Parts 404 and 416

Revised Medical Criteria for Evaluating Musculoskeletal Disorders;
Proposed Rule

Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed
Rules

[[Page 20646]]

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SOCIAL SECURITY ADMINISTRATION

20 CFR Parts 404 and 416

[Docket No. SSA-2006-0112]
RIN 0960-AG38

Revised Medical Criteria for Evaluating Musculoskeletal Disorders

AGENCY: Social Security Administration.

ACTION: Notice of proposed rulemaking.

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SUMMARY: We propose to revise the criteria in the Listing of
Impairments (listings) that we use to evaluate claims involving
musculoskeletal disorders in adults and children under titles II and
XVI of the Social Security Act (Act). These proposed revisions reflect
our adjudicative experience, advances in medical knowledge and
treatment of musculoskeletal disorders, and recommendations from
medical experts.

DATES: To ensure that your comments are considered, we must receive
them no later than July 6, 2018.

ADDRESSES: You may submit comments by one of three methods--internet,
fax, or mail. Do not submit the same comments multiple times or by more
than one method. Regardless of which method you choose, please state
that your comments refer to Docket No. SSA-2006-0112 so that we may
associate your comments with the correct regulation.
Caution: You should be careful to include in your comments only
information that you wish to make publicly available. We strongly urge
you not to include in your comments any personal information, such as
Social Security numbers or medical information.
1. Internet: We strongly recommend that you submit your comments
via the internet. Please visit the Federal eRulemaking portal at https://www.regulations.gov. Use the Search function to find docket number
SSA-2006-0112. The system will issue you a tracking number to confirm
your submission. You will not be able to view your comment immediately
because we must post each comment manually. It may take up to a week
for your comment to be viewable.
2. Fax: Fax comments to (410) 966-2830.
3. Mail: Address your comments to the Office of Regulations and
Reports Clearance, Social Security Administration, 107 Altmeyer
Building, 6401 Security Boulevard, Baltimore, Maryland 21235-6401.
Comments are available for public viewing on the Federal
eRulemaking portal at https://www.regulations.gov or in person, during
regular business hours, by arranging with the contact person identified
below.

FOR FURTHER INFORMATION CONTACT: Cheryl A. Williams, Office of
Disability Policy, Social Security Administration, 6401 Security
Boulevard, Baltimore, Maryland 21235-6401, (410) 965-1020. For
information on eligibility or filing for benefits, call our national
toll-free number, 1-800-772-1213, or TTY 1-800-325-0778, or visit our
internet site, Social Security Online, at https://www.socialsecurity.gov.

SUPPLEMENTARY INFORMATION: This notice of proposed rulemaking (NPRM) is
divided into several parts. First, we provide the supplementary
information, which is often referred to as the preamble. In the
preamble, we explain why we propose to revise the listings for the
musculoskeletal body system and how we developed the proposed rules. We
also offer a narrative of the changes we are proposing. The preamble
tells the story behind the proposed rule changes, but if we decide to
proceed with a final rule, the preamble will not become part of the
Code of Federal Regulations.
The next section is the proposed revisions to the listing of
impairments, located in Appendix 1 to Subpart P of 20 CFR part 404. For
each body system affected by these proposed rules (e.g., 1.00
Musculoskeletal Disorders), we first provide proposed changes to the
introductory text (e.g., 1.00A, B, C, etc.). If we decide to proceed
with a final rule, the introductory text will become part of the Code
of Federal Regulations. The introductory text details which disorders
we evaluate and what evidence we need to conduct this evaluation. It
also defines certain terms, and provides valuable background
information. Individuals often refer to the introductory text for
additional details related to a specific listing under which a
medically determinable impairment (MDI) is being evaluated. After the
introductory text, we provide specific listing text and criteria (e.g.,
1.15 and 1.16). The listings themselves provide specific criteria that
an MDI must meet (or medically equal) in order for an individual to be
found disabled under the listings.

I. Why are we proposing to revise the listings for the musculoskeletal
body system?

We last published final rules that revised the musculoskeletal body
system on November 19, 2001.\1\ We are now proposing to update the
introductory text and criteria in the current listings to reflect our
adjudicative experience, advances in medical knowledge and treatment of
musculoskeletal disorders, and comments and recommendations from
medical experts.
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\1\ 66 FR 58010. We also made a conforming change to the rules
for musculoskeletal disorders when we published final rules revising
the rules for immune system disorders on March 18, 2006 (73 FR
14570).
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While we believe our proposed revisions reflect advances in medical
knowledge and treatment of musculoskeletal disorders, we are interested
in receiving public comments on the following issues:
Are there any musculoskeletal disorders that will meet one
of the proposed listings, but are generally expected to medically
improve after a certain amount of time to the point at which the
disorders will no longer be of listing-level severity? If you believe
there are musculoskeletal disorders that fit into this category, please
tell us by submitting your comments and any supporting research or
data. We will use your comments on this issue to inform our policy on
the timing of continuing disability reviews.\2\
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\2\ See Sec. Sec. 404.1590 and 416.990 of this chapter for our
policy on when we will conduct a continuing disability review.
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Are the proposed functional criteria appropriate and
sufficient for assessing listing level severity? If you believe the
proposed functional criteria are either insufficient for documenting an
impairment that meets a listing-level severity, or you believe these
criteria will exclude eligible individuals with an impairment of
listing-level severity, please tell us by submitting your comments and
any supporting research or data.
Did we remove or omit any valuable information that should
be included in the introductory text? We intend for this text to ease
administrative burdens for adjudicators, claimants, claimant
representatives, and the public by clarifying terms, removing
extraneous language, and providing guidance in an orderly fashion. If
you believe we removed or omitted any valuable information, please tell
us by submitting your comments and any supporting research or data.
Should any of the proposed listings for musculoskeletal
disorders be combined into one listing or divided into multiple
listings for adjudicative ease and capture individuals with impairments
that meet a listing-level severity? If you believe our listing
categories create unnecessary administrative barriers for impairments
that meet listing level severity, please

[[Page 20647]]

tell us by submitting your comments and any supporting research or
data.
Did we appropriately define ``close proximity of time'' in
section 1.00C7 as meaning that all of the relevant criteria have to
appear in the medical record within a period not to exceed 4 months of
one another for musculoskeletal disorders? The 4-month threshold
represents a period in which an individual receiving treatment for a
chronic severe musculoskeletal impairment will undergo multiple
examinations or treatments from their medical source(s). Individuals
with chronic severe musculoskeletal impairments typically undergo
multiple examinations or treatments. Therefore, we believe a 4-month
threshold provides individuals with adequate time to receive multiple
medical treatments documenting the existence of listing level criteria,
should the relevant criteria exist. If you believe the ``close
proximity of time'' should be defined by a different measure than 4
months, please tell us by submitting your comments and any supporting
research or data.
Based on advances in medical surgical, recuperative, and
functionally restorative treatment of musculoskeletal disorders, would
the proposed listing criteria allow us to adequately assess whether an
individual has achieved ``maximum benefit from therapy'' or whether an
individual is ``under continuing surgical management''? It is important
that we do not encourage or incentivize individuals to increase their
medical treatment to maintain or access disability benefits,
particularly medical treatments that would likely be ineffective, or
that may even be harmful, for the individual? If you believe ``the
maximum therapeutic benefits'' criterion should be revised and
evaluated by a different measure, please tell us by submitting your
comments and any supporting research or data.

II. How did we develop these proposed rules?

As medicine and medical treatment are continuously evolving, we
utilized well-known references such as the Guides to the Evaluation of
Permanent Impairment from the American Medical Association, Harrison's
Principles of Internal Medicine, Current Diagnosis & Treatment in
Orthopedics, and Nelson Textbook of Pediatrics as a starting point to
develop the proposed changes to these rules.\3\ We also requested
extensive input from our medical consultants (physicians employed by or
who contract with us) who have years of experience practicing in
relevant fields of medicine and who have intimate knowledge of our
disability programs to develop our proposed changes to the
musculoskeletal disorders listings. We rely on our medical consultants
and their professional opinions based on their clinical experience and
research to help us develop what criteria correspond with listing-level
severity.
---------------------------------------------------------------------------

\3\ Full citations are available in X. References below.
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In developing our proposed rule changes, we used the resources
above, our programmatic knowledge, our adjudicative experience, and the
medical literature, such as Archives of Physical Medicine and
Rehabilitation, Journal of the American Academy of Orthopaedic
Surgeons, and Hand Clinics. These resources informed us of the most
recent best practices and medical advancements and either support, or
are consistent with, our proposed rule changes.
In addition to these distinguished medical sources and our medical
consultants, in proposing these changes to the musculoskeletal
disorders listings, we used information from:
People who make and review disability determinations and
decisions for us in State agencies, in our Office of Quality Review,
and in our Office of Hearing Operations;
Comments we received regarding the 2001 ``Final rules with
request for comment,'' \4\ which we used as a starting point for
identifying areas needing further research; and
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\4\ The final rules with request for comments are available at
https://www.gpo.gov/fdsys/pkg/FR-2001-11-19/pdf/01-28456.pdf.
Comments on the final rules may be found at https://www.regulations.gov/ gov/, and search for ``SSA-2006-0112''.
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Additional published sources we list in the References
section at the end of this preamble, including the National Academies
of Sciences, Engineering, and Medicine, Health and Medicine Division
(formerly the Institute of Medicine).

III. What major revisions are we proposing?

We propose to revise both the content and the structure of the
adult and childhood musculoskeletal disorders listings and introductory
texts as follows:
Provide uniform and specific severity criteria for
evaluating the effects of a musculoskeletal disorder on a person's
functioning;
Revise the introductory texts in 1.00 Musculoskeletal
Disorders and 101.00 Musculoskeletal Disorders to provide guidance on
the specific severity criteria;
Add specific sections in the introductory texts in 1.00
Musculoskeletal Disorders and 101.00 Musculoskeletal Disorders to
provide guidance on each listing;
Revise the content and structure of the current listings
to incorporate the new severity criteria into each listing;
Add listings for evaluating pathologic fractures due to
any cause (1.19 Pathologic fractures due to any cause for adults and
101.19 Pathologic fractures due to any cause for children);
Add a child listing for evaluating musculoskeletal
disorders of infants and toddlers, from birth to attainment of age 3,
with developmental motor delay (101.24 Musculoskeletal disorders of
infants and toddlers, from birth to attainment of age 3, with
developmental motor delay);
Use the same general structure in most adult and child
listings, consisting of symptoms, signs, laboratory findings, and
applicable functional criteria, in that order;
Remove current 1.02 and 101.02 Major dysfunction of a
joint(s) (due to any cause) and incorporate the provisions in proposed
1.18 and 101.18 Abnormality of a major joint(s) in any extremity;
Remove current 1.04 Disorders of the spine and 1.04A
``Evidence of nerve root compression,'' and incorporate the provisions
of 1.04A in proposed 1.15 Disorders of the skeletal spine resulting in
compromise of a nerve root(s);
Remove current 1.04B ``Spinal arachnoiditis'' because it
is a secondary effect, rather than a primary skeletal spine disorder,
which can be evaluated under proposed 1.16 Lumbar spinal stenosis
resulting in compromise of the cauda equina;
Remove current 1.04C ``Lumbar spinal stenosis,'' and
incorporate its provisions in proposed 1.16 Lumbar spinal stenosis
resulting in compromise of the cauda equina;
Remove current 101.04 Disorders of the spine and
incorporate the provisions in proposed 101.15 Disorders of the skeletal
spine resulting in compromise of a nerve root(s) and 101.16 Lumbar
spinal stenosis resulting in compromise of the cauda equina;
Remove current 1.05 and 101.05 Amputation (due to any
cause), and incorporate its provisions in proposed 1.20 and 101.20
Amputation due to any cause;
Remove current 1.06 and 101.06 Fracture of the femur,
tibia, pelvis, or one or more of the tarsal bones; and incorporate the
provisions of those listings in proposed 1.22 and 101.22 Non-healing or
complex fracture of the

[[Page 20648]]

femur, tibia, pelvis, or one or more of the tarsal bones;
Remove current 1.07 and 101.07 Fracture of an upper
extremity; and incorporate the provisions of those listings in proposed
1.23 and 101.23 Non-healing or complex fracture of an upper extremity;
and
Remove current 1.08 and 101.08 Soft tissue injury (e.g.,
burns), and incorporate the provisions in proposed 1.21 and 101.21 Soft
tissue injury or abnormality under continuing surgical management.

IV. What changes are we proposing to the introductory text of the
musculoskeletal disorders listings for adults?

We propose to adopt a question-and-answer framework to make the
guidance contained in the introduction easier for adjudicators,
claimants, claimant representatives, and the public to locate, and to
make the introductory text consistent with the format used in other
body systems.
We propose to remove the phrases ``loss of function'' and
``functional loss'' and replace the content of current 1.00B1 General,
101.00B1 General, 1.00B2 How we define loss of function in these
listings, and 101.00B2 How We Define Loss of Function in These
Listings. We are replacing the content of 1.00B1 General and 101.00B1
General because it may be read to imply that we require an absence of
function in order to evaluate an impairment under these listings.
Except in the case of amputation, the proposed listings do not require
a complete absence of function. In 1.00B2 How We Define Loss of
Function in These Listings and 101.00B2 How We Define Loss of Function
in These Listings, we are removing the descriptive phrases, ``inability
to ambulate effectively,'' ``extreme limitation of the ability to
walk,'' ``interferes very seriously with the individual's ability to
independently initiate, sustain, or complete activities,''
``ineffective ambulation,'' and ``independent ambulation,'' along with
the corresponding examples in that paragraph. We are replacing these
descriptors with uniform and specific severity criteria, which we
believe will provide clearer guidance for adjudicators and the public.
We propose to provide new uniform and specific functional criteria,
which we describe in the introductory text for each listing, for
evaluating the severity of limitations caused by musculoskeletal
disorders. We chose these particular functional criteria because they
clearly illustrate the level of dysfunction for upper and lower
extremities that would cause an adult to be unable to work, or that
would cause a child to be unable to perform age-appropriate activities.
The effects of a particular disorder on musculoskeletal functioning,
and the treatment needed, direct which of these criteria are
appropriate for each of the listings. The functional criteria for
adults are as follows:
1. A documented medical need for a walker, bilateral canes, or
bilateral crutches;
2. An inability to use one upper extremity to independently
initiate, sustain, and complete work-related activities involving fine
and gross movements, and a documented medical need for a one-handed
assistive device that requires the use of the other upper extremity; or
3. An inability to use both upper extremities to the extent that
neither can be used to independently initiate, sustain, and complete
work-related activities involving fine and gross movements.
In developing this uniform and specific severity criteria, we
utilized medical resources, such as ``Ambulatory Assistive Devices in
Orthopaedics: Uses and Modifications,'' \5\ the professional experience
of our medical consultants, information related to workplace
functioning from the Bureau of Labor Statistics, and our adjudicative
experience. Each of these criteria illustrate restrictions of multiple
extremities and thus, significant limitations.
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\5\ Full citation is available in X. References, below.
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We propose to explain each proposed listing in separate sections of
the introduction.
The following chart shows the headings of the current and proposed
sections of the adult introductory text:

------------------------------------------------------------------------
Current introductory text Proposed introductory text
------------------------------------------------------------------------
A. Disorders of the musculoskeletal A. Which disorders do we
system. evaluate under these listings?
B. Loss of function.................... B. Which related disorders do
we evaluate under other
listings?
C. Diagnosis and Evaluation............ C. What evidence do we need to
evaluate your musculoskeletal
disorder under these listings?
D. The physical examination............ D. How do we consider symptoms,
including pain, under these
listings?
E. Examination of the Spine............ E. How do we use the functional
criteria under these listings?
F. Major joints........................ F. What do we consider when we
evaluate disorders of the
skeletal spine resulting in
compromise of a nerve root(s)
(1.15)?
G. Measurements of joint motion........ G. What do we consider when we
evaluate lumbar spinal
stenosis resulting in
compromise of the cauda equina
(1.16)?
H. Documentation....................... H. What do we consider when we
evaluate reconstructive
surgery or surgical
arthrodesis of a major weight-
bearing joint (1.17)?
I. Effects of Treatment................ I. What do we consider when we
evaluate abnormality of a
major joint(s) in any
extremity (1.18)?
J. Orthotic, Prosthetic, or Assistive J. What do we consider when we
Devices. evaluate pathologic fractures
due to any cause (1.19)?
K. Disorders of the spine.............. K. What do we consider when we
evaluate amputation due to any
cause (1.20)?
L. Abnormal curvatures of the spine.... L. What do we consider when we
evaluate soft tissue injury or
abnormality under continuing
surgical management (1.21)?
M. Under continuing surgical management M. What do we consider when we
evaluate non-healing or
complex fractures of the
femur, tibia, pelvis, or one
or more of the tarsal bones
(1.22)?
N. After maximum benefit from therapy N. What do we consider when we
has been achieved. evaluate non-healing or
complex fractures of an upper
extremity (1.23)?

[[Page 20649]]

O. Major function of the face and head. O. How do we determine when
your soft tissue injury or
abnormality, or your upper
extremity fracture, is no
longer under continuing
surgical management or you
have received maximum
therapeutic benefit?
P. When surgical procedures have been P. How do we evaluate the
performed. severity and duration of your
established musculoskeletal
disorder when there is no
record of ongoing treatment?
Q. Effects of obesity.................. Q. How do we evaluate substance
use disorders that co-exist
with musculoskeletal
disorders?
R. How do we evaluate disorders
that do not meet one of the
musculoskeletal listings?
------------------------------------------------------------------------

Proposed 1.00--Introduction

The following is a detailed description of the changes we propose
to the introductory text.
Proposed 1.00A--Which disorders do we evaluate under these listings?
We propose to revise current 1.00A Disorders of the musculoskeletal
system to explain that we evaluate musculoskeletal disorders that
result in dysfunction of the skeletal spine or of the upper or lower
extremities,\6\ fractures, and soft tissue \7\ abnormalities or
injuries that are under continuing surgical management.
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\6\ Impairments involving the shoulders will typically affect
upper extremities while the impairments involving the pelvis, hips,
and ribs typically affect lower extremities. When assessing
dysfunction, the resultant incapacity or limitation is key to
assessing the impairment under the applicable medical listing.
\7\ Soft tissue refers to non-skeletal tissues that make up a
large percentage of the body, such as the tendons, ligaments, fascia
and muscles.
---------------------------------------------------------------------------

We begin with listings for disorders affecting functioning of the
skeletal spine, because our adjudicative experience shows that these
are the most frequently used listings in this body system.
Proposed 1.00B--Which related disorders do we evaluate under other
listings?
We propose to replace the content of current 1.00B Loss of function
with improved guidance for disorders that affect musculoskeletal
functioning, which we evaluate under other listings. We explain that we
evaluate injuries of the skeletal spine resulting in dysfunction of the
spinal cord under 11.00 Neurological Disorders, and we evaluate
inflammatory arthritis under 14.00 Immune System Disorders. We state
that we evaluate abnormal curvatures of the spine that adversely affect
functioning in other body systems under the appropriate listing in the
affected body system. We have removed the guidance from current 1.00L
that states ``Abnormal curvatures of the spine (specifically,
scoliosis, kyphosis and kyphoscoliosis) can result in impaired
ambulation, but may also adversely affect functioning in body systems
other than the musculoskeletal system.'' Instead, we propose to
evaluate spinal curvatures that affect musculoskeletal functioning
under proposed 1.15 Disorders of the skeletal spine resulting in
compromise of a nerve root(s), depending on the area of dysfunction
created by the curvature. We also state that we can evaluate a
curvature of the spine that is under continuing surgical management
under proposed 1.21 Soft tissue injury or abnormality under continuing
surgical management.
Proposed 1.00C--What evidence do we need to evaluate your
musculoskeletal disorder under these listings?
We propose to replace current 1.00C Diagnosis and Evaluation with a
comprehensive explanation of the information and evidence we need to
evaluate musculoskeletal disorders. Once we establish the disorder, we
evaluate evidence from medical and non-medical sources to assess
severity and duration under the musculoskeletal listings. We describe
the elements needed in a physical examination report. We discuss
laboratory and other test findings and their usefulness and
limitations, and we explain our policy concerning evaluation of imaging
and other diagnostic tests. We discuss our need for operative reports
and what we will accept in the absence of such reports, incorporating
the guidance from current introductory section 1.00P When surgical
procedures have been performed. We identify the evidence we need
concerning a person's treatment and response to it.
In section 1.00C6 Assistive devices, we clarify what we mean by a
prosthesis(es) and an orthosis(es). We discuss the evidence we need
when a person with a musculoskeletal disorder uses an assistive
device(s), including a cane(s), crutch(es), walker, prosthesis(es), or
orthosis(es).
In section 1.00C7 Longitudinal evidence, we explain the importance
of a longitudinal medical record in determining whether a
musculoskeletal disorder satisfies the duration requirement. We explain
that, for all listings except 1.19 Pathologic fractures due to any
cause, 1.20A ``Amputation of both upper extremities'' 1.20B
``Hemipelvectomy or hip disarticulation'', and 1.21 Soft tissue injury
or abnormality under continuing surgical management, all listing
criteria must be present simultaneously, or within a close proximity of
time; and must have lasted, or be expected to last, for a continuous
period of at least 12 months for a disorder to meet a listing.
In section 1.00C What evidence do we need to evaluate your
musculoskeletal disorder under these listings?, we clarify that, when
the listing criteria are linked by the word ``and'' (whether in small
case or capital case), the requirements must be simultaneously present,
or present within a ``close proximity of time,'' which we define in
section 1.00C7 as meaning that all of the relevant criteria have to
appear in the medical record within a period not to exceed 4 months of
one another. Consistent with the standard of care and common industry
practice, according to our medical consultants, literature review, and
external medical experts, such as those from the Health and Medicine
Division at the National Academies of Science Engineering and Medicine,
an individual receiving treatment for a chronic severe musculoskeletal
impairment will typically receive treatment or undergo examination at
least once every 3 months. Should an individual meet an applicable
listing, the listing criteria is likely to be documented every third
month. The 4-month threshold provides leeway in cases where a physical
examination might not be performed or symptoms are not documented at a
given appointment. The 4-month threshold represents a period in which
individuals receiving treatment for a chronic severe musculoskeletal
impairment will undergo multiple examinations or treatments from their
medical source(s), providing a window encompassing multiple medical

[[Page 20650]]

appointments over which applicable listing criteria can be adequately
documented. The 4-month threshold does not apply to imaging.
We propose to add this clarification to address a holding in
Radford v. Colvin, 734 F.3d 288 (4th Cir. 2013) with respect to current
1.04A Disorders of the spine, ``Evidence of nerve root compression.''
The Radford Court held that ``[a] claimant need not show that each
symptom was present at precisely the same time--i.e., simultaneously--
in order to establish the chronic nature of his condition. Nor need a
claimant show that the symptoms were present in the claimant in
particularly close proximity.'' \8\
---------------------------------------------------------------------------

\8\ 734 F.3d at 294.
---------------------------------------------------------------------------

Because this holding of the Radford Court differed from our
interpretation of the listing requirement, we issued Acquiescence
Ruling (AR) 15-1(4) to implement the Court of Appeals holding within
the States in the Fourth Circuit.\9\ We now propose to clarify our
longstanding interpretation of the regulations in response to the
Radford decision. We also propose to clarify that this policy applies
to other listings that have similar requirements.
---------------------------------------------------------------------------

\9\ 80 FR 57418 (2015). Available at: https://www.ssa.gov/OP_Home/rulings/ar/04/AR2015-01-ar-04.html.
---------------------------------------------------------------------------

The issuance of a new regulation to address a holding of a Court of
Appeals that conflicts with our policy is consistent with the process
described in our regulations for issuing and rescinding Acquiescence
Rulings. Our regulations specifically contemplate that we may
``subsequently publish a new regulation(s) addressing an issue(s) not
previously included in our regulations when that issue(s) was the
subject of a circuit court holding that conflicted with our
interpretation of the Social Security Act or regulations and that
holding was not compelled by the statute or Constitution.'' 20 CFR
404.985(e)(4), 416.1485(e)(4). After we have considered the public
comments in response to these proposed rules and issued any final
rules, we will decide whether we need to rescind the Radford AR.
Section 1.00C8 Surgical treatment, discusses how we evaluate
surgical treatment. We explain when and why we may wait to receive
additional evidence before making a determination of disability.
Proposed 1.00D--How do we consider symptoms, including pain, under
these listings?
We propose to replace current 1.00D The physical examination with
guidance about how we consider symptoms of musculoskeletal impairments,
particularly pain. We explain that your pain must be supported by
medical signs and laboratory findings, established by medically
acceptable clinical, laboratory, or diagnostic techniques, showing the
existence of a medical impairment(s) which results from anatomical,
physiological, or psychological abnormalities.
Proposed 1.00E--How do we use the functional criteria under these
listings?
We propose to replace current 1.00E Examination of the Spine with
new guidance about how we use the functional criteria to evaluate
musculoskeletal disorders under these listings. We explain what we mean
by functional criteria, we list the criteria, and we explain why
listings 1.20A `Amputation of both upper extremities'', 1.20B
``Hemipelvectomy or hip disarticulation'' and 1.21 Soft tissue injury
or abnormality under continuing surgical management do not include the
functional criteria. We also explain that we will evaluate a person's
functioning with respect to the work environment, rather than the home
environment, because the ability to walk independently about one's home
without the use of assistive devices does not, in and of itself,
indicate an ability to walk without an assistive device in a work
environment. We explain that in order to be disabling, a
musculoskeletal disorder must satisfy the medical criteria as well as
the 12-month duration requirement and, where applicable, must include
at least one of the functional criteria of a listing.
Proposed 1.00F--What do we consider when we evaluate disorders of the
skeletal spine resulting in compromise of a nerve root(s) (1.15)?
We propose to replace the content of current 1.00F Major joints
with guidance regarding how we evaluate disorders of the skeletal spine
under proposed 1.15 Disorders of the skeletal spine resulting in
compromise of a nerve root(s). In proposed 1.00F, we list the various
spinal disorders that result in compromise of nerve roots; we explain
the symptoms and signs associated with those disorders; and we explain
how a medical source evaluates those symptoms and signs in clinical
examinations.
Proposed 1.00G--What do we consider when we evaluate lumbar spinal
stenosis resulting in compromise of the cauda equina (1.16)?
We propose to replace the content of current 1.00G Measurements of
joint motion with guidance about how we evaluate the effects of
compromise of the cauda equina due to lumbar spinal stenosis under
proposed 1.16 Lumbar spinal stenosis resulting in compromise of the
cauda equina. We explain how lumbar spinal stenosis can compromise the
cauda equina; we provide a more detailed discussion of the cauda equina
and associated symptoms and signs; and we explain how the disorder
affects functioning. We also explain the difference between pain caused
by compromise of the cauda equina (neurogenic claudication or
pseudoclaudication) and pain caused by peripheral arterial disease
(vascular claudication).
Proposed 1.00I--What do we consider when we evaluate abnormality of a
major joint(s) in any extremity (1.18)?
We propose to replace the content of current 1.00I Effects of
Treatment with guidance about how we evaluate abnormality in a major
joint(s) under proposed 1.18 Abnormality of a major joint(s) in any
extremity. We explain how we define abnormalities of the joints, and
give specific examples of the types of diseases, injuries, and other
conditions that may contribute to joint dysfunction. We also explain
how these disorders interfere with functions of the extremities.
Proposed 1.00J--What do we consider when we evaluate pathologic
fractures due to any cause (1.19)?
We propose to replace the content of current 1.00J Orthotic,
Prosthetic, or Assistive Devices with guidance regarding how we
evaluate pathologic fractures under proposed new 1.19 Pathologic
fractures due to any cause. We explain what we mean by ``pathologic
fractures;'' we state that these types of fractures can affect the
skeletal spine, extremities, or other parts of the skeletal system; we
give examples of disorders that can cause pathologic fractures; and we
explain how we evaluate their occurrence and recurrence.
Proposed 1.00K--What do we consider when we evaluate amputation due to
any cause (1.20)?
We propose to replace the content of current 1.00K Disorders of the
spine with guidance about how we evaluate amputation due to any cause
under proposed 1.20 Amputation due to any

[[Page 20651]]

cause. We explain that we evaluate amputations involving upper or lower
extremities and combinations of those extremities, as well as
hemipelvectomies and hip disarticulations. We explain that when a
person has amputations of one upper extremity at any level above the
wrist and one lower extremity at or above the ankle, we consider
whether the person has a documented medical need for a one-handed
assistive device. We also explain how we consider amputation of one or
both lower extremities at or above the ankle (tarsal joint). We state
that we use this listing when a person has residual limb complications
that have lasted, or are expected to last, for at least 12 months, and
the person is not currently undergoing surgical management.
Proposed 1.00L--What do we consider when we evaluate soft tissue injury
or abnormality under continuing surgical management (1.21)?
We propose to replace the content of current 1.00L Abnormal
curvatures of the spine with guidance about how we evaluate soft tissue
abnormality or injury of any part of the body that is under continuing
surgical management. We also incorporate the provisions of current
sections 1.00M Under continuing surgical management, 1.00N After
maximum benefit from therapy has been achieved, 1.00O Major function of
the face and head, and 1.00P When surgical procedures have been
performed. We explain that we use proposed 1.21 Soft tissue injury or
abnormality under continuing surgical management to evaluate any soft
tissue abnormality or injury, whether congenital or acquired, including
malformations, third- and fourth-degree burns, craniofacial injuries,
avulsive injuries, amputations with complications of the residual
limb(s), and complications of non-healing or complex traumatic
fractures. We explain that a person must have a documented medical need
for a continuing series of ongoing surgical procedures and associated
medical treatments, directed toward saving, reconstructing, or
replacing the affected part of the body. We further explain that these
treatments must have been, or must be expected to be, ongoing for a
continuous period of least 12 months. We list the clinical evidence we
need to determine whether a disorder meets this listing. We explain how
we evaluate third- and fourth-degree burns and craniofacial injuries.
We also explain how we evaluate when maximum therapeutic benefit has
occurred and how we evaluate residual impairment.
Proposed 1.00M--What do we consider when we evaluate non-healing or
complex fractures of the femur, tibia, pelvis, or one or more of the
tarsal bones (1.22)?
We propose to replace the content of current 1.00M Under continuing
surgical management with guidance about how we evaluate non-healing or
complex fractures involving bones in the lower extremity. We also
provide definitions for ``non-healing fracture'' and ``complex
fracture.''
Proposed 1.00N--What do we consider when we evaluate non-healing or
complex fractures of an upper extremity (1.23)?
We propose to replace the content of current 1.00N After maximum
benefit from therapy with guidance about how we evaluate non-healing or
complex fractures involving bone in the upper extremity. We also
provide definitions for ``non-healing fracture'' and ``complex
fracture.''
Proposed 1.00O--How do we determine your soft tissue injury or
abnormality or your upper extremity fracture is no longer under
continuing surgical management or you have received maximum therapeutic
benefit?
We propose to replace the content of current 1.00O Major function
of the face and head with guidance about determining when a soft tissue
injury or abnormality or upper extremity fracture is no longer under
continuing surgical management. We also incorporate the provisions of
current sections 1.00M Under continuing surgical management, 1.00N
After maximum benefit from therapy has been achieved, and 1.00P When
surgical procedures have been performed.
Proposed 1.00P--How do we evaluate the severity and duration of your
established musculoskeletal disorder when there is no record of ongoing
treatment?
We propose to replace the content of current 1.00P When surgical
procedures have been performed with guidance about how we assess
impairments when there is no longitudinal medical record. We explain
that when the individual has not received ongoing treatment or has just
begun treatment, we may ask the individual to attend a consultative
examination. We also explain that we may be able to assess the severity
and duration of the individual's impairment based on the medical record
and current evidence alone. In this section, we incorporate guidance
from current section 1.00H3 When there is no record of ongoing
treatment.
Proposed 1.00R--How do we evaluate disorders that do not meet one of
the musculoskeletal listings?
We propose to add a new section 1.00R with guidance explaining that
if a person's disorder does not meet or medically equal the criteria of
any of these listings, we will consider whether it meets or medically
equals the criteria for a listing in another body system. We explain
that if an impairment does not meet or medically equal any listing, we
will assess the person's residual functional capacity (RFC) and
determine whether the person is capable of performing past work or
adjusting to other work in the national economy. We also cite the rules
we use when we determine whether a person continues to be disabled. In
this section, we incorporate guidance from current section 1.00H4
Evaluation when the criteria of a musculoskeletal listing are not met.

V. What changes are we proposing to the musculoskeletal listings for
adults?

We propose to revise the name of the body system from
``Musculoskeletal System'' to ``Musculoskeletal Disorders.''
We propose to rename the headings of the listings and to renumber
the listings in a more logical order, beginning with disorders of the
spine, as those are the most frequently used; moving outward physically
to the extremities; and then to skeletal or soft tissue injuries. When
these rules become final, renumbering the listings should make it
easier for us to keep track of data trends for specific types of
impairments over time. It should also help to prevent confusion in
identifying or referring to prior listings after we publish a final
rule.
We propose to present the overall structure of the listings in an
outline form to make the rules more readily accessible to the reader.
The following chart provides a comparison of the current and the
proposed adult listings:

[[Page 20652]]

------------------------------------------------------------------------
Current listing Proposed listing
------------------------------------------------------------------------
1.02 Major dysfunction of a joint(s) 1.02 Removed without
(due to any cause). replacement.
1.03 Reconstructive surgery or surgical 1.03 Removed without
arthrodesis of a major weight-bearing replacement.
joint.
1.04 Disorders of the spine............ 1.04 Removed without
replacement.
1.05 Amputation (due to any cause)..... 1.05 Removed without
replacement.
1.06 Fracture of the femur, tibia, 1.06 Removed without
pelvis, or one or more of the tarsal replacement.
bones.
1.07 Fracture of an upper extremity.... 1.07 Removed without
replacement.
1.08 Soft tissue injury (e.g., burns).. 1.08 Removed without
replacement.
1.15 Disorders of the skeletal
spine resulting in compromise
of a nerve root(s).
1.16 Lumbar spinal stenosis
resulting in compromise of the
cauda equina.
1.17 Reconstructive surgery or
surgical arthrodesis of a
major weight-bearing joint.
1.18 Abnormality of a major
joint(s) in any extremity.
1.19 Pathologic fractures due
to any cause.
1.20 Amputation due to any
cause.
1.21 Soft tissue injury or
abnormality under continuing
surgical management.
1.22 Non-healing or complex
fracture of the femur, tibia,
pelvis, or one or more of the
tarsal bones
1.23 Non-healing or complex
fracture of an upper
extremity.
------------------------------------------------------------------------

All of the proposed musculoskeletal listings contain multiple
criteria. We distinguish whether all of the criteria must be met in
order to meet that specific listing or just one of the criteria must be
met in order to meet that specific listing by using a capital ``AND''
or ``OR,'' respectively. The ``AND'' or ``OR'' sit on a line
independently on the left margin. We also distinguish whether all sub-
criteria must be met or just one of the sub-criteria must be met in
order to satisfy the relevant criteria by using a lowercase ``and'' or
``or,'' respectively.

1.15 Disorders of the Skeletal Spine Resulting in Compromise of a Nerve
Root(s)

Proposed 1.15 Disorders of the skeletal spine resulting in
compromise of a nerve root(s) incorporates and clarifies the provisions
of current 1.04A for evidence of nerve root compression. In proposed
1.15 we have removed references to the particular disorders associated
with compromise of a nerve root(s) and discussion of the tests used to
demonstrate them. We have incorporated the references to specific
disorders in the introductory text because they are examples of
possible causative agents, whereas the listing addresses the effects of
those agents on the nerve root(s). We have also removed the sign of
atrophy from the listing because medical research and our experience
does not show atrophy necessarily correlates with any given level of
functioning. We have provided for consideration of limitation of motion
by evaluating the physical limitation of musculoskeletal functioning it
causes using the new functional criteria. Under proposed criterion
1.15B for radicular neurological signs, we have included muscle
weakness and sensory changes. We have also added the requirement for
``[d]ecreased deep tendon reflexes'' to the criterion because it is a
manifestation of the disorder and illustrates our intentions for this
listing. A criterion for imaging, which is not explicitly required in
current 1.04A, has been added as proposed 1.15C ``Findings on imaging
consistent with compromise of a nerve root(s)'' because it is a
component necessary to establishing the disorder.

1.16 Lumbar Spinal Stenosis Resulting in Compromise of the Cauda Equina

Proposed 1.16 Lumbar spinal stenosis resulting in compromise of the
cauda equina incorporates and clarifies the provisions of current 1.04C
for lumbar spinal stenosis resulting in pseudoclaudication. We
incorporate each of the requirements in current 1.04C into sections A-D
of the proposed listing and clarify the current requirements with
specific information in sections A-C. We have made a separate listing
for compromise of the cauda equina due to the effects of lumbar spinal
stenosis, because the symptoms and signs of this disorder differ from
those of other nerve root(s) disorders and are not typically associated
with a specific nerve root(s).

1.17 Reconstructive Surgery or Surgical Arthrodesis of a Major Weight-
Bearing Joint

Proposed 1.17 Reconstructive surgery or surgical arthrodesis of a
major weight-bearing joint incorporates and clarifies the provisions of
current listing 1.03 Reconstructive surgery or surgical arthrodesis of
a major weight-bearing joint.

1.18 Abnormality of a Major Joint(s) in Any Extremity

Proposed 1.18 Abnormality of a major joint(s) in any extremity
incorporates and clarifies the provisions of current listings 1.02
Major dysfunction of a joint(s) (due to any cause). It includes the
criteria from current 1.02 for evaluating dysfunction of any of the
major joints in either the upper or lower extremities, or both, whether
due to anatomical deformity, pain, or abnormal motion. We removed the
terms ``peripheral'' and ``weight-bearing,'' which are in the current
listing for major joint disorders (1.02 Major dysfunction of a joint(s)
(due to any cause)), because proposed 1.18 covers all major joints in
any extremity, making those distinctions unnecessary.

1.19 Pathologic Fractures Due to Any Cause

Proposed 1.19 Pathologic fractures due to any cause is a new
listing that covers pathologic fractures of any part of the
musculoskeletal system. Medical treatment and recovery expectations for
fractures differ, depending on whether the condition is due to an
underlying pathology (such as osteoporosis), or to a traumatic event.
For this reason, we propose a separate listing for fractures caused by
an underlying pathology in order to provide specific criteria related
to their evaluation and adjudication. We propose to evaluate complex or
non-

[[Page 20653]]

healing traumatic fractures under proposed 1.22 Non-healing or complex
fracture of the femur, tibia, pelvis, or one or more of the tarsal
bones or 1.23 Non-healing or complex fracture of an upper extremity.

1.20 Amputation Due to Any Cause

Proposed 1.20 Amputation due to any cause incorporates and
clarifies the provisions of current 1.05 Amputation (due to any cause).
Proposed 1.20B for hemipelvectomy or hip disarticulation corresponds to
current 1.05D for hemipelvectomy or hip disarticulation. In proposed
1.20A for amputation of both upper extremities and 1.20B for
hemipelvectomy or hip disarticulation, we do not include any functional
criteria, because we presume that a person with a disorder under either
proposed 1.20A or 1.20B has limitations that satisfy one or more of the
functional criteria in 1.00E2 and meet the duration requirement.

1.21 Soft Tissue Injury or Abnormality Under Continuing Surgical
Management

Proposed 1.21 Soft tissue injury or abnormality under continuing
surgical management revises current listing 1.08 Soft tissue injury
(e.g., burns). This proposed listing is consistent with our long-
standing recognition that extensive, prolonged treatment in order to
re-establish or improve function of the affected body part(s) may
contribute to an inability to perform work-related activity.
It encompasses any abnormality of, or injury (including burns) to
soft tissue that is under continuing surgical management directed
toward saving, reconstructing, or replacing the affected part of the
body. In proposed 1.21, we do not include any functional criteria
because the prescribed surgical procedures treatments typically require
a series of documented interventions over extended periods, which
render the person unable to perform work-related activity on a
sustained basis.

1.22 Non-Healing or Complex Fracture of the Femur, Tibia, Pelvis, or
One or More of the Tarsal Bones

Proposed 1.22 Non-healing or complex fracture of the femur, tibia,
pelvis, or one or more of the tarsal bones incorporates and clarifies
the provisions of current listing 1.06 Fracture of the femur, tibia,
pelvis, or one or more of the tarsal bones.

1.23 Non-Healing or Complex Fracture of an Upper Extremity

Proposed 1.23 Non-healing or complex fracture of an upper extremity
incorporates and clarifies the provisions of current listing 1.07
Fracture of an upper extremity.

VI. What changes are we proposing to the introductory text of the
musculoskeletal disorders listings for children?

The same basic rules for evaluating musculoskeletal disorders in
adults apply to the evaluation of such disorders in children. Except
for changes in the introductory text specific to children, we propose
to repeat most of the introductory text of proposed 1.00
Musculoskeletal Disorders in the introductory text of proposed 101.00
Musculoskeletal Disorders. Since we have already described these
proposed revisions in the introductory text of proposed 1.00, we
describe here only those sections of the proposed 101.00 rules that are
unique to children or that require further explanation.
The following chart shows the headings of the current and proposed
sections of the childhood introductory text:

------------------------------------------------------------------------
Current introductory text Proposed introductory text
------------------------------------------------------------------------
A. Disorders of the musculoskeletal A. Which disorders do we
system. evaluate under these listings?
B. Loss of Function.................... B. Which related disorders do
we evaluate under other
listings?
C. Diagnosis and Evaluation............ C. What evidence do we need to
evaluate your musculoskeletal
disorder under these listings?
D. The physical examination............ D. How do we consider symptoms,
including pain, under these
listings?
E. Examination of the Spine............ E. How do we use the functional
criteria under these listings?
F. Major joints........................ F. What do we consider when we
evaluate disorders of the
skeletal spine resulting in
compromise of a nerve root(s)
(101.15)?
G. Measurements of joint motion........ G. What do we consider when we
evaluate lumbar spinal
stenosis resulting in
compromise of the cauda equina
(101.16)?
H. Documentation....................... H. What do we consider when we
evaluate reconstructive
surgery or surgical
arthrodesis of a major weight-
bearing joint (101.17)?
I. Effects of Treatment................ I. What do we consider when we
evaluate abnormality of a
major joint(s) in any
extremity (101.18)?
J. Orthotic, Prosthetic, or Assistive J.What do we consider when we
Devices. evaluate pathologic fractures
due to any cause (101.19)?
K. Disorders of the spine.............. K. What do we consider when we
evaluate amputation due to any
cause (101.20)?
L. Abnormal curvatures of the spine.... L. What do we consider when we
evaluate soft tissue injury or
abnormality under continuing
surgical management (101.21)?
M. Under continuing surgical management M. What do we consider when we
evaluate non-healing or
complex fractures of the
femur, tibia, pelvis, or one
or more of the tarsal bones
(101.22)?
N. After maximum benefit from therapy N. What do we consider when we
has been achieved. evaluate non-healing or
complex fractures of an upper
extremity (101.23)?
O. Major function of the face and head. O. What do we consider when we
evaluate musculoskeletal
disorders of infants and
toddlers from birth to
attainment of age 3 with
developmental motor delay
(101.24)?
P. When surgical procedures have been P. How do we determine when
performed. your soft tissue injury or
abnormality, or your upper
extremity fracture, is no
longer under continuing
surgical management or you
have received maximum
therapeutic benefit?
Q. How do we evaluate the
severity and duration of your
established musculoskeletal
disorder when there is no
record of ongoing treatment?
R. How do we evaluate disorders
that do not meet one of the
musculoskeletal listings?
------------------------------------------------------------------------

[[Page 20654]]

VII. What changes are we proposing to the musculoskeletal disorders
listings for children?

We propose to revise the name of the body system from
``Musculoskeletal System'' to ``Musculoskeletal Disorders.''
We propose to add 101.24 Musculoskeletal disorders of infants and
toddlers, from birth to attainment of age 3, with developmental motor
delay. This listing evaluates developmental motor delay due to a
musculoskeletal medically determinable impairment as a functional
criterion for infants and toddlers. We propose to move the requirement
of developmental motor skills that are no greater than one-half of the
expected age performance from current 101.00B2c(2) How we assess
inability to perform fine and gross movements in very young children
into proposed 101.24. Proposed 101.24 does not have an adult
counterpart.
We propose to use functional criteria for children that are the
same as the criteria for adults.
The following chart provides a comparison of the current childhood
listings and the proposed childhood listings:

------------------------------------------------------------------------
Current childhood listings Proposed childhood listings
------------------------------------------------------------------------
101.02 Major dysfunction of a joint(s) 101.02 Removed without
(due to any cause). replacement.
101.03 Reconstructive surgery or 101.03 Removed without
surgical arthrodesis of a major weight- replacement.
bearing joint.
101.04 Disorders of the spine.......... 101.04 Removed without
replacement.
101.05 Amputation (due to any cause)... 101.05 Removed without
replacement.
101.06 Fracture of the femur, tibia, 101.06 Removed without
pelvis, or one or more of the tarsal replacement.
bones.
101.07 Fracture of an upper extremity.. 101.07 Removed without
replacement.
101.08 Soft tissue injury (e.g., burns) 101.08 Removed without
replacement.
101.15 Disorders of the
skeletal spine resulting in
compromise of a nerve root(s).
101.16 Lumbar spinal stenosis
resulting in compromise of the
cauda equina.
101.17 Reconstructive surgery
or surgical arthrodesis of a
major weight-bearing joint.
101.18 Abnormality of a major
joint(s) in any extremity.
101.19 Pathologic fractures due
to any cause.
101.20 Amputation due to any
cause.
101.21 Soft tissue injury or
abnormality under continuing
surgical management.
101.22 Non-healing or complex
fracture of the femur, tibia,
pelvis, or one or more of the
tarsal bones.
101.23 Non-healing or complex
fracture of an upper
extremity.
101.24 Musculoskeletal
disorders of infants and
toddlers, from birth to
attainment of age 3, with
developmental motor delay.
------------------------------------------------------------------------

As is the case with adults, for children, all of the proposed
musculoskeletal listings contain multiple criteria. We distinguish
whether all of the criteria must be met in order to meet that specific
listing or just one of the criteria must be met in order to meet that
specific listing by using a capital ``AND'' or ``OR,'' respectively.
The ``AND'' or ``OR'' sit on a line independently on the left margin.
We also distinguish whether all sub-criteria must be met or just one of
the sub-criteria must be met in order to satisfy the relevant criteria
by using a lowercase ``and'' or ``or,'' respectively.

VIII. Other Changes

We propose to make conforming changes to current sections 4.00G4
What is lymphedema and how will we evaluate it? and 104.00F9 What is
lymphedema and how will we evaluate it? of the cardiovascular system
listings to indicate that we may evaluate whether lymphedema medically
equals proposed listings 1.18 and 101.18 Abnormality of a major
joint(s) in any extremity.
We propose to make conforming changes to the introductory text and
listing criteria for immune system disorders. Many disorders of the
immune system affect the musculoskeletal system; therefore, we are
making these revisions to reflect this relationship and ensure
consistency in our evaluation of musculoskeletal functioning. In 14.00C
Definitions and 114.00C Definitions, we propose to provide explanations
of terms for evaluating immune system disorders consistent with those
we propose for evaluating musculoskeletal disorders. We propose to add
definitions for ``assistive device(s),'' ``documented medical need,''
``fine and gross movements,'' and ``hand-held assistive device.'' We
also propose to replace ``major peripheral joints'' with ``major joint
of an upper or lower extremity,'' to revise the explanation of that
term, and to remove the terms ``inability to ambulate effectively'' and
``inability to perform fine and gross movements effectively'' for
consistency with the proposed musculoskeletal disorders listings.
We propose to revise the information in current sections 14.00D4
Polymyositis and dermatomyositis (14.05) and 114.00D4 ``Polymyositis
and dermatomyositis (114.05)'' describing how we evaluate polymyositis
and dermatomyositis in motor skills of newborns, younger infants,
children, and adults. We propose to revise these sections for
consistency with the proposal to remove the term ``unable to ambulate
effectively.'' We propose to replace ``ambulate effectively'' with
``walk without physical or mechanical assistance.''
We propose to make editorial changes to current sections 14.00D6
Inflammatory arthritis (14.09) and 114.00D6 Inflammatory arthritis
(114.09). We propose to replace ``major peripheral joints'' with
``major joints in an upper or lower extremity,'' ``ambulation or fine
and gross movements'' with ``walking or performing fine and gross
movements,'' and ``ambulation or the performance of fine and gross
movements'' with ``walking or performing fine and gross movements.''

[[Page 20655]]

We propose to make conforming changes to describe listing-level
severity in proposed listing criteria 14.09A and 114.09A ``Persistent
inflammation or persistent deformity'' as follows: we propose to
replace ``an impairment that results in an `extreme' (very serious)
limitation'' with ``the presence of an impairment-related, significant
limitation cited in the criteria of these listings.'' We propose to
replace ``one major peripheral weight-bearing joint resulting in the
inability to ambulate effectively'' with ``one major joint in a lower
extremity resulting in a documented medical need for a walker,
bilateral canes, or bilateral crutches.'' We propose to replace ``one
major peripheral joint in each upper extremity resulting in the
inability to perform fine and gross movements effectively'' with ``one
major joint in each upper extremity resulting in an impairment-related,
significant limitation in the ability to perform fine and gross
movements.''
To describe listing-level severity in current listing criteria
14.09C and 114.09 C ``Ankylosing spondylitis or other
spondyloarthropathies'' we propose to replace ``extreme limitation''
with ``impairment-related significant limitation'' and ``inability to
ambulate effectively'' with ``a documented medical need for a walker,
bilateral canes, or bilateral crutches.''
To describe listing-level severity in current listing criteria
14.09B, C, and D and 114.09B and C for impairments due to inflammatory
arthritis, we also propose to replace ``major peripheral joints'' with
``major joints in an upper or lower extremity.''
We propose to revise current section 114.00J2b ``Musculoskeletal
involvement, such as surgical reconstruction of a joint, under 101.00''
to indicate that we may evaluate immune system disorders in children
involving developmental motor delay under 101.00 Musculoskeletal
Disorders.
We propose conforming changes to current immune system disorders
listings 14.04 Systemic sclerosis (scleroderma), 14.05 Polymyositis and
dermatomyositis, 14.09 Inflammatory arthritis, 114.04 Systemic
sclerosis (scleroderma), 114.05 Polymyositis and dermatomyositis and
114.09 Inflammatory arthritis. In proposed 14.04 Systemic sclerosis
(scleroderma), 14.05 Polymyositis and dermatomyositis, and 14.09
Inflammatory arthritis for adults, we would replace ``inability to
ambulate effectively'' with the requirement of one of the following:
A documented medical need for a walker, bilateral canes,
or bilateral crutches; or
An inability to use one upper extremity to independently
initiate, sustain, and complete work-related activities involving fine
and gross movements, and a documented medical need for a one-handed
assistive device that requires the use of the other upper extremity.
In proposed 114.04 Systemic sclerosis (scleroderma), 114.05
Polymyositis and dermatomyositis, and 114.09 Inflammatory arthritis for
children, we would replace ``inability to ambulate effectively'' with
the requirement of one of the following:
A documented medical need for a walker, bilateral canes,
or bilateral crutches; or
An inability to use one upper extremity to independently
initiate, sustain, and complete age-appropriate activities involving
fine and gross movements, and a documented medical need for a one-
handed assistive device that requires the use of the other upper
extremity.
In proposed 14.04 Systemic sclerosis (scleroderma), 14.05
Polymyositis and dermatomyositis, and 14.09 Inflammatory arthritis for
adults, we would replace ``inability to perform fine and gross
movements effectively'' with ``inability to use both upper extremities
to the extent that neither can be used to independently initiate,
sustain, and complete work-related activities involving fine and gross
movements.''
In proposed 114.04 Systemic sclerosis (scleroderma), 114.05
Polymyositis and dermatomyositis, and 114.09 Inflammatory arthritis for
children, we would replace ``inability to perform fine and gross
movements effectively'' with ``inability to use both upper extremities
to the extent that neither can be used to independently initiate,
sustain, and complete age-appropriate activities involving fine and
gross movements.''
In proposed 14.09 Inflammatory arthritis and 114.09 Inflammatory
arthritis, we would replace ``major peripheral weight-bearing joints''
with ``major joints in a lower extremity(ies).'' In proposed 14.09
Inflammatory arthritis and 114.09 Inflammatory arthritis, we would
replace ``major peripheral joints'' with ``major joints'' or ``major
joints of an upper or lower extremity(ies),'' as appropriate for the
affected extremity(-ies).
We propose to remove the first and second examples in Sec.
416.926a(m) of this chapter, Examples of impairments that functionally
equal the listings. The first example is ``[a]ny condition that is
disabling at the time of onset, requiring continuing surgical
management within 12 months after onset as a life-saving measure or for
salvage or restoration of function, and such major function is not
restored or is not expected to be restored within 12 months after onset
of this condition.'' (See Sec. 416.926a(m)(1) of this chapter.) We are
removing this example because, at the time it was written, there were
no specific criteria that considered the need for ongoing surgical
management in the listings. The second example is ``[e]ffective
ambulation possible only with obligatory bilateral upper limb
assistance.'' (See Sec. 416.926a(m)(2) of this chapter.) We are
removing this example because several of the proposed childhood
listings include a criterion considering ``. . . a documented medical
need for a walker, bilateral canes, or bilateral crutches'' (that is,
``obligatory bilateral upper limb assistance.'') With the inclusion of
the proposed childhood listings, it will no longer be necessary to have
these examples in the regulations.

IX. Administrative Matters

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

The Social Security Act authorizes us to make rules and regulations
and to establish necessary and appropriate procedures to implement
them.\10\
---------------------------------------------------------------------------

\10\ Sections 205(a), 702(a)(5), and 1631(d)(1).
---------------------------------------------------------------------------

How long would these proposed rules be effective?

If we publish these proposed rules as final rules, they will remain
in effect for 5 years after the date they become effective, unless we
extend them, or revise and issue them again.

Clarity of These Proposed Rules

Executive Order 12866, as supplemented by Executive Order 13563,
requires each agency to write all rules in plain language. In addition
to your substantive comments on these proposed rules, we invite your
comments on how to make them easier to understand.
For example:
Would more, but shorter, sections be better?
Are the requirements in the rules clearly stated?
Have we organized the material to suit your needs?
Could we improve clarity by adding tables, lists, or
diagrams?
What else could we do to make the rules easier to
understand?
Do the rules contain technical language or jargon that is
not clear?

[[Page 20656]]

Would a different format make the rules easier to
understand, e.g., grouping and order of sections, use of headings,
paragraphing?

Anticipated Economic Impact of the Proposed Rules

Financial Classification of SSA's Regulations

Based on criteria established by OMB Circular A-4 and Executive
Order 13771, we classify this rule as a ``transfer rule.'' Transfer
rules do not create or impose novel costs; rather, they regulate the
transfer of monetary payments from one group to another without
affecting the total resources available to society.
Under our Old-Age, Survivors, and Disability Insurance program
(OASDI), SSA's regulations govern the transfer of benefits payments to
qualified workers primarily from revenues collected from payroll taxes
(FICA) and self-employment taxes (SECA). Under the Supplemental
Security Income (SSI) program, funded by general tax revenues, SSA
makes payments to individuals with limited income and resources who are
aged, blind, or disabled.
This proposed rule establishes eligibility criteria for
transferring disability payments to those persons who qualify for such
payments based on the presence of a musculoskeletal body system
disorder.

Anticipated Accounting Costs of These Proposed Rules

Anticipated Costs to Our Programs

For fiscal years (FY) 2018-2022, our Office of the Chief Actuary
estimates that this proposed rule, once finalized, may result in a
reduction of $57,000,000 to our OASDI program costs, and an increase of
$11,000,000 to our SSI program costs. It is important to note that due
to the roughly offsetting estimated effects of changes from allowance
to denial and from denial to allowance, the true net effect for either
program, OASDI or SSI, could potentially be either a small cost or a
small saving.

Anticipated Administrative Costs to the Social Security Administration

In calculating whether the implementation of this proposed rule,
once finalized, may result in administrative costs or savings to the
agency, we examine two sources: (1) Work-years and (2) direct financial
administrative costs.
We define work-years as a measure of the SSA employee work time a
proposed rule will cost or save during implementation of its policies.
We calculate one work-year as 2,080 hours of labor, which represents
the amount of hours one SSA employee works per year based on a standard
40-hour workweek.
We estimate the direct financial administrative costs of a proposed
rule by examining requirements stemming from new regulations, including
systems start-up and maintenance costs, operational costs resulting
from new workloads, and internal training costs for relevant agency
staff and adjudicators. To assess savings resulting from a proposed
rule, we examine Systems and operational workload changes.
Based on the above factors, our Office of Budget, Finance, and
Management estimates that implementation of these proposed rules, upon
finalization, will result in overall administrative savings for SSA of
fewer than 15 work-years and less than $2 million annually for the
period of FY 2018-2022.

When will we start to use these rules?

We will not use these rules until we evaluate public comments and
publish final rules in the Federal Register. All final rules we issue
include an effective date. We will continue to use our current rules
until that date. If we publish final rules, we will include a summary
of those relevant comments we received along with responses and an
explanation of how we will apply the new rules.

Regulatory Procedures

Executive Order 12866, as Supplemented by Executive Order 13563

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

Regulatory Flexibility Act

We certify that this NPRM will not have a significant economic
impact on a substantial number of small entities because it affects
individuals only. Therefore, a regulatory flexibility analysis is not
required under the Regulatory Flexibility Act, as amended.

Paperwork Reduction Act

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

X. References

We consulted the following references when we developed these
proposed rules:

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Vaidya, R., Carp, J., Bartol, S., Ouellette, N., Lee, S., & Sethi,
A. (2009). Lumbar spine fusion in obese and morbidly obese patients.
Spine, 34(5), 495-500. https://doi.org/10.1097/BRS.0b013e318198c5f2.
Varni, J.W., Stucky, B.D., Thissen, D., Dewitt, E.M., Irwin, D.E.,
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We included these references in the rulemaking record for these
proposed rules and will make them available for inspection by
interested individuals who make arrangements with the contact person
identified above.

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

List of Subjects

20 CFR Part 404

Administrative practice and procedure; Blind, Disability benefits;
Old-Age, survivors, and disability insurance; Reporting and
recordkeeping requirements; Social Security.

20 CFR Part 416

Administrative practice and procedure, Blind, Disability benefits,
Public assistance programs, Reporting and recordkeeping requirements,
Supplemental Security Income (SSI).

Nancy A. Berryhill,
Acting Commissioner of Social Security.

For the reasons set out in the preamble, we propose to amend 20
CFR, chapter III, part 404, subpart P as set forth below:

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

Subpart P--[Amended]

0
1. The authority citation for subpart P of part 404 continues to read
as follows:

Authority: Secs. 202, 205(a)-(b) and (d)-(h), 216(i), 221(a)
and (h)-(j), 222(c), 223, 225, and 702(a)(5) of the Social Security
Act (42 U.S.C. 402, 405(a)-(b) and (d)-(h), 416(i), 421(a) and (h)-
(j), 422(c), 423, 425, and 902(a)(5)); sec. 211(b), Pub. L. 104-193,
110 Stat. 2105, 2189; sec. 202, Pub. L. 108-203, 118 Stat. 509 (42
U.S.C. 902 note).

0
2. Amend appendix 1 to subpart P of part 404 as follows:
0
a. Revise item 2 of the introductory text before part A;
0
b. Amend part A by revising the body system name for section 1.00 in
the table of contents;
0
c. Revise section 1.00 of part A;
0
d. Revise the second sentence of paragraph 4.00G4b of part A;
0
e. Redesignate current 14.00C2 through 14.00C12 of part A as follows:

------------------------------------------------------------------------
Old section New section
------------------------------------------------------------------------
14.00C2 14.00C3
14.00C3 14.00C4
14.00C4 14.00C6
14.00C5 14.00C7
14.00C6 14.00C8
14.00C7 14.00C9
14.00C8 14.00C10
14.00C9 14.00C11
14.00C10 14.00C12
14.00C11 14.00C13
14.00C12 14.00C14
------------------------------------------------------------------------

0
f. Add new paragraphs 14.00C2 and 14.00C5 to part A;
0
g. Revise 14.00C8 through 14.00C10;
0
h. Revise the first sentence of paragraph 14.00D4c(i) of part A;
0
i. Revise the second and third sentences of paragraph 14.00D6a of part
A;
0
j. Revise paragraph 14.00D6e(i) and the first sentence of 14.00D6e(ii)
of part A;
0
k. Revise 14.04B, 14.04C2, and 14.05A of part A;
0
l. Revise 14.09A and the first sentence of 14.09B of part A;
0
m. Amend part B by revising the body system name for section 101.00 in
the table of contents;
0
n. Revise section 101.00 of part B;
0
o. Revise the second sentence of paragraph 104.00F9b of part B;
0
p. Redesignate current 114.00C2 through 114.00C12 of part B as follows:

------------------------------------------------------------------------
Old section New section
------------------------------------------------------------------------
114.00C2................................................ 114.00C3
114.00C3................................................ 114.00C4
114.00C4................................................ 114.00C6
114.00C5................................................ 114.00C7
114.00C6................................................ 114.00C8
114.00C7................................................ 114.00C9
114.00C8................................................ 114.00C10
114.00C9................................................ 114.00C11
114.00C10............................................... 114.00C12
114.00C11............................................... 114.00C13
114.00C12............................................... 114.00C14
------------------------------------------------------------------------

0
q. Add new paragraphs 114.00C2 and 114.00C5 to part B;

[[Page 20659]]

0
r. Revise 114.00C8 through 114.00C10;
0
s. Revise the first sentence of paragraph 114.00D4c(ii) of part B;
0
t. Revise the second and third sentences of paragraph 114.00D6a of part
B;
0
u. Revise paragraph 114.00D6e(i) and the first sentence of
114.00D6e(ii) of part B;
0
v. Revise listings 114.04B, 114.04C2, and 114.05A of part B; and
0
w. Revise 114.09A and the heading of 114.09B of part B.
The revisions read as follows:

Appendix 1 to Subpart P of Part 404--Listing of Impairments

* * * * *
2. Musculoskeletal Disorders (1.00 and 101.00): [THIS EXPIRES 5
YEARS FROM THE EFFECTIVE DATE OF THE FINAL RULES].
* * * * *

Part A

* * * * *

1.00 Musculoskeletal Disorders.

* * * * *

1.00 Musculoskeletal Disorders

A. Which disorders do we evaluate under these listings?
1. We evaluate disorders of the skeletal spine (vertebral
column) or of the upper or lower extremities that affect
musculoskeletal functioning in the musculoskeletal body system
listings. We use the term ``skeletal'' when we are referring to the
structure of the bony skeleton. The skeletal spine refers to the
bony structures, ligaments, and discs making up the spine. We refer
to the ``skeletal'' spine in some musculoskeletal listings to
differentiate it from the neurological spine (see 1.00B1). Disorders
may be congenital or acquired, and may include deformities,
amputations, or other musculoskeletal abnormalities. These disorders
may involve the bones or major joints; or the tendons, ligaments,
muscles, or other soft tissues.
2. We also evaluate soft tissue abnormalities or injuries
(including burns) that are under continuing surgical management (see
1.00L1). The abnormalities or injuries may affect any part of the
body, including the face and skull.
B. Which related disorders do we evaluate under other listings?
1. We evaluate a disorder or injury of the skeletal spine that
results in damage to, and neurological dysfunction of, the spinal
cord and its associated nerves (for example, paraplegia or
quadriplegia) under the criteria in 11.00 Neurological Disorders.
2. We evaluate inflammatory arthritis (for example, rheumatoid
arthritis) under the criteria in 14.00 Immune System Disorders.
3. We evaluate curvatures of the skeletal spine under these
musculoskeletal disorders listings and other listings as appropriate
for the affected body system. Curvatures of the skeletal spine that
affect musculoskeletal functioning are evaluated under 1.15
Disorders of the skeletal spine resulting in compromise of a nerve
root(s). If a curvature of the skeletal spine is under continuing
surgical management, we can evaluate it for medical equivalence to
1.21 Soft tissue injury or abnormality under continuing surgical
management. Curvatures of the skeletal spine may also adversely
affect functioning in body systems other than the musculoskeletal
system. For example, the curvature may interfere with your ability
to breathe (see 3.00 Respiratory Disorders); there may be impaired
myocardial function (see 4.00 Cardiovascular System); or there may
be disfigurement resulting in social withdrawal or depression (see
12.00 Mental Disorders).
4. We evaluate non-healing or pathological fractures due to
cancer, whether it is a primary site or metastases, under the
criteria in 13.00 Cancer (Malignant Neoplastic Diseases).
5. We evaluate the leg pain associated with peripheral vascular
claudication, as well as diabetic foot ulcers, under the criteria in
4.00 Cardiovascular System.
6. We evaluate burns that do not require continuing surgical
management under the criteria in 8.00 Skin Disorders.
C. What evidence do we need to evaluate your musculoskeletal
disorder under these listings?
1. General. To establish the presence of a musculoskeletal
disorder as a medically determinable impairment, we need objective
medical evidence from an acceptable medical source who has examined
you for the disorder. To assess the severity and duration of your
disorder, we evaluate evidence from both medical and nonmedical
sources who can describe how you function. If there is no record of
ongoing medical treatment for your disorder, we will follow the
guidelines in 1.00P How do we evaluate the severity and duration of
your established musculoskeletal disorder when there is no record of
ongoing treatment? We will determine the extent and kinds of
evidence we need from medical and non-medical sources based on the
individual facts about your disorder. For our basic rules on
evidence, see Sec. Sec. 404.1502, 404.1512, 404.1513, 404.1513a,
404.1520b, 416.902, 416.912, 416.913, 416.913a, and 416.920b of this
chapter. For our rules on evidence about your symptoms, see
Sec. Sec. 404.1529 and 416.929 of this chapter.
2. Physical examination report(s). In the report(s) of your
physical examination, we need a detailed description of the
orthopedic, neurologic, or other objective clinical findings
appropriate to your specific musculoskeletal disorder. We require
objective clinical findings from the medical source's direct
observations during your physical examination, not simply his or her
report of your statements about your symptoms and limitations. When
the medical source reports that a clinical test sign(s) is positive,
unless we have evidence to the contrary, we will assume that he or
she performed the test properly. For instance, we will assume a
straight-leg raising test was conducted properly, i.e., in a sitting
and supine position, even if the medical source does not specify the
positions in which the test was performed. In the absence of
evidence to the contrary, we will accept the medical source's
interpretation of the test. If you use an assistive device (see
1.00C6), the report must support the medical need for the device. If
reduction in muscle strength is a factor, we require medical
documentation of measurement of the strength of the muscle(s) in
question, generally based on a grading system of 0 to 5. Zero (0)
indicates complete loss of strength and 5 indicates maximum
strength, consistent with Table 1 below. The documentation should
also include measurements of grip and pinch strength, if there is
evidence of involvement of one or both hands.

Table 1
------------------------------------------------------------------------

------------------------------------------------------------------------
Grading Scale of Muscle Function: 0 to 5
------------------------------------------------------------------------
0............................. None............. No visible or
palpable
contraction.
1............................. Trace............ Visible or palpable
contraction with no
motion.
2............................. Poor............. Active range of
motion (ROM) with
gravity eliminated.
3............................. Fair............. Active ROM against
gravity only,
without resistance.
4............................. Good............. Active ROM against
gravity, moderate
resistance.
5............................. Normal........... Active ROM against
gravity, maximum
resistance.
------------------------------------------------------------------------

[[Page 20660]]

your symptoms, including pain, or with your musculoskeletal
functioning. Accordingly, we cannot use such tests as a substitute
for physical examination findings about your ability to function,
nor can we infer severity or functional limitations based solely on
such tests.
d. For our policies about when we will purchase imaging and
other diagnostic tests, see Sec. Sec. 404.1519k, 404.1519m,
416.919k, and 416.919m of this chapter.
4. Operative reports. If you have had a surgical procedure(s),
we need either the operative reports, including details of the
findings at surgery and information about any medical complications
that may have occurred, or confirmatory evidence of the surgical
procedure(s) from a medical source (for example, detailed follow-up
reports or notations in the medical records concerning your past
medical history).
5. Effects of treatment
a. General. Treatments for musculoskeletal disorders may have
beneficial or adverse effects, and responses to treatment vary from
person to person. We will evaluate all of the effects of treatment
(including surgical treatment, medications, and therapy) on the
symptoms, signs, and laboratory findings of your musculoskeletal
disorder, and on your musculoskeletal functioning.
b. Response to treatment. To evaluate your musculoskeletal
functioning in response to treatment, we need specific information
related to your impairment, including the following: A description
of your medications, including frequency of administration; the type
and frequency of therapy you receive; and a description of your
response to treatment and any complications you experience related
to your impairment. The effects of treatment may be temporary or
long-term. We need information over a sufficient period to determine
the effect of treatment on your current musculoskeletal functioning
and to permit reasonable projections about your future functioning.
In some cases, we will need additional evidence to make an
assessment about your response to treatment. Depending upon the
timing of this treatment in relation to the alleged onset date of
disability, we may need to defer evaluation of the impairment for a
period of up to 3 months from the date treatment began to permit
consideration of treatment effects, unless we can make a
determination or decision using the evidence we have.
6. Assistive devices
a. General. An assistive device, for the purposes of these
listings, is any device that is used to improve stability,
dexterity, or mobility. An assistive device can be worn (see 1.00C6b
and c), or hand-held (see 1.00C6d). If you use any type of assistive
device(s), we need evidence from a medical source regarding the
documented medical need for the device(s). When we use the term
``documented medical need,'' we mean that there is evidence from a
medical source(s) in the medical record that supports your need for
an assistive device (see Sec. Sec. 404.1513 and 416.913 of this
chapter). The evidence must include documentation from a medical
source(s) describing any limitation(s) in your upper or lower
extremity functioning that supports your need for the assistive
device(s), and the circumstances for which you need it. The evidence
does not have to include a specific prescription for the device(s).
b. Prosthesis(es). A prosthesis is a wearable device, such as an
artificial limb, that takes the place of an absent body part. We
need evidence from a medical source documenting your ability to
walk, or to perform fine and gross movements (see 1.00E3), with the
prosthesis(es) in place. When amputation(s) involves a lower
extremity or extremities, it is not necessary to evaluate your
ability to walk without the prosthesis(es) in place. If you cannot
use your prosthesis(es) due to complications affecting your residual
limb(s), we need documentation from a medical source regarding the
condition of your residual limb(s) and the medical basis for your
inability to use the prosthesis(es).
c. Orthosis(es). An orthosis is a wearable device that prevents
or corrects a dysfunction or deformity by aligning or supporting the
affected body part. An orthosis may also be referred to as a
``brace.'' If you have an orthosis(es), we need evidence from a
medical source documenting your ability to walk, or to perform fine
and gross movements, with the orthosis(es) in place. If you cannot
use your orthosis(es), we need evidence from a medical source
documenting the medical basis for your inability to use the
device(s).
d. Hand-held assistive devices. Hand-held assistive devices
include canes, crutches, or walkers, and are carried in your hand(s)
to support or aid you in walking. When you require a one-handed
assistive device for ambulation, such as a cane or single crutch,
and your other upper extremity has limitations preventing its use
for fine or gross movement(s) (see 1.00E3), the need for the
assistive device limits the use of both upper extremities. If you
use a hand-held assistive device, we need evidence from a medical
source documenting your need for the device(s) and describing how
you walk with the device(s).
7. Longitudinal evidence
a. We generally need a longitudinal medical record to assess the
duration of your musculoskeletal disorder, because symptoms, signs,
and laboratory findings related to most musculoskeletal disorders
may wax and wane, may improve over time, or may respond to
treatment. By providing evidence over an extended period, the
medical record will show whether your musculoskeletal functioning is
improving, worsening, or unchanging.
b. For 1.19 Pathologic fractures due to any cause and 1.21 Soft
tissue injury or abnormality under continuing surgical management,
the required 12-month duration period is stated in the listing
itself. For 1.20A (amputation of both upper extremities) or 1.20B
(hemipelvectomy or hip disarticulation), we presume satisfaction of
the duration requirement.
c. For all listings not referenced in 1.00C7b above, all of the
required criteria must be present simultaneously, or within a close
proximity of time, to satisfy the level of severity needed to meet
the listing. When we use the term ``close proximity of time,'' we
mean that all of the relevant criteria have to appear in the medical
record within a period not to exceed 4 months of one another. When
the criterion in question is imaging, we mean those findings on
imaging that we could reasonably expect to have been present at the
date of impairment or date of onset. To meet a listing that uses the
word ``and'' or ``AND'' to link the elements of the required
criteria, the medical record must establish the simultaneous
presence, or presence within a close proximity of time, of all the
required medical criteria. Once this level of severity is
established, the medical record must also show that this level of
severity has continued, or is expected to continue, for a continuous
period of at least 12 months.
8. Surgical treatment
For some musculoskeletal disorders, a medical source may
recommend surgery. If you have not yet had the recommended surgery,
we will not deny your claim based on an assumption that surgery will
resolve or improve your disorder. We will assess each case on an
individual basis. Depending on your response to treatment, or
depending on your medical sources' treatment plans, we may defer our
findings regarding the effect of surgical intervention until a
sufficient period has passed to permit proper consideration or
judgment about your future functioning. See 1.00C5b Response to
treatment.
D. How do we consider symptoms, including pain, under these
listings?
1. Individuals with musculoskeletal disorders may experience
pain or other symptoms; however, statements alone about your pain or
other symptoms cannot establish that you are disabled. Further, an
alleged or reported increase in the intensity of a symptom, such as
pain, no matter how severe, cannot be substituted for a medical sign
or diagnostic finding present in the listing criteria. Pain is
included as just one consideration in paragraph A in listings 1.15,
1.16, and 1.18, but is not required to satisfy the criteria in these
listings. Examples of other findings that will satisfy the criteria
in paragraph A include muscle fatigue, nonradicular distribution of
sensory loss in one or both extremities, and joint stiffness.
2. To consider your pain, we require objective medical evidence
from an acceptable medical source showing the existence of a
medically determinable impairment(s) (MDI) that could reasonably be
expected to produce the pain. When your musculoskeletal MDI could
reasonably be expected to produce the pain or other symptoms
alleged, we consider all your symptoms, including pain, and the
extent to which your symptoms can reasonably be accepted as
consistent with all of the objective medical evidence, including
medical signs and laboratory or diagnostic findings. See Sec. Sec.
404.1529 and 416.929 of this chapter for information on how we
evaluate pain or other symptoms related to a musculoskeletal
impairment.
E. How do we use the functional criteria under these listings?
1. General. We will determine that your musculoskeletal disorder
meets a listing if it satisfies the medical criteria; includes at
least one of the functional criteria, if included in the listing;
and satisfies the 12-month duration requirement. We will use the
relevant evidence that we have to evaluate

[[Page 20661]]

your musculoskeletal functioning with respect to the work
environment rather than the home environment. For example, an
ability to walk independently at home without an assistive device
does not, in and of itself, indicate an ability to walk without an
assistive device in a work environment.
2. Functional criteria. The functional criteria are based on
impairment-related physical limitations in your ability to use both
upper extremities, one or both lower extremities, or a combination
of one upper and one lower extremity. A musculoskeletal disorder
satisfies the functional criteria of a listing when the medical
documentation shows the presence of at least one of the impairment-
related limitations cited in the listing. The required impairment-
related physical limitation of musculoskeletal functioning must have
lasted, or be expected to last, for a continuous period of at least
12 months, medically documented by one of the following:
a. A documented medical need (see 1.00C6a) for a walker,
bilateral canes, or bilateral crutches (see 1.00C6d);
b. An inability to use one upper extremity to independently
initiate, sustain, and complete work-related activities involving
fine and gross movements (see 1.00E3), and a documented medical need
(see 1.00C6a) for a one-handed assistive device (see 1.00C6d) that
requires the use of your other upper extremity;
c. An inability to use both upper extremities to the extent that
neither can be used to independently initiate, sustain, and complete
work-related activities involving fine and gross movements (see
1.00E3).
3. Fine and gross movements. Fine movements, for the purposes of
these listings, involve use of your wrists, hands, and fingers; such
movements include picking, pinching, manipulating, and fingering.
Gross movements involve use of your shoulders, upper arms, forearms,
and hands; such movements include handling, gripping, grasping,
holding, turning, and reaching. Gross movements also include
exertional abilities such as lifting, carrying, pushing, and
pulling. Examples of inability to perform fine and gross movements
include, but are not limited to, the inability to take care of
personal hygiene, the inability to sort and handle papers or files,
and the inability to place files in a file cabinet at or above waist
level.
4. When we do not use the functional criteria. We do not use the
functional criteria to evaluate amputation of both upper extremities
under 1.20A, hemipelvectomy or hip disarticulation under 1.20B, and
soft tissue injuries or abnormalities under continuing surgical
management under 1.21.
F. What do we consider when we evaluate disorders of the
skeletal spine resulting in compromise of a nerve root(s) (1.15)?
1. General. We consider musculoskeletal disorders such as
herniated nucleus pulposus, spinal osteoarthritis (spondylosis),
vertebral slippage (spondylolisthesis), degenerative disc disease,
facet arthritis, and vertebral fracture or dislocation. Spinal
disorders may cause cervical or lumbar spine dysfunction when
abnormalities of the skeletal spine compromise nerve roots of the
cervical spine, a nerve root of the lumbar spine, or a nerve root of
both cervical and lumbar spines.
2. Compromise of a nerve root(s). Compromise of a nerve root(s),
sometimes referred to as ``nerve root impingement,'' is a term used
when a physical object is seen pushing on the nerve root in an
imaging study or during surgery. Objects such as tumors, herniated
discs, foreign bodies, or arthritic spurs may cause compromise of a
nerve root. It can occur when a musculoskeletal disorder produces
irritation, inflammation, or compression of the nerve root(s) as it
exits the skeletal spine between the vertebrae. Related symptoms
must be associated with, or follow the path of, the specific nerve
root(s), thereby presenting a neuro-anatomic (usually referred to as
``radicular'') distribution of symptoms and signs, including pain,
paresthesia (for example, burning, prickling, or tingling), sensory
loss, and usually muscle weakness specific to the affected nerve
root(s).
a. Compromise of unilateral nerve root of the cervical spine.
Compromise of a nerve root as it exits the cervical spine between
the vertebrae may affect the functioning of the associated upper
extremity. The clinical examination reproduces the related symptoms
based on radicular signs and clinical tests (for example, a positive
Spurling's test) appropriate to the specific cervical nerve root.
b. Compromise of bilateral nerve roots of the cervical spine.
Although uncommon, if compromise of a nerve root occurs on both
sides of the cervical spinal column, functioning of both upper
extremities may be limited.
c. Compromise of a nerve root(s) of the lumbar spine. Compromise
of a nerve root as it exits the lumbar spine between the vertebrae
may limit the functioning of the associated lower extremity. The
clinical examination reproduces the related symptoms based on
radicular signs and clinical tests. When a nerve root of the lumbar
spine is compromised, we require a positive straight-leg raising
test (also known as a Lasegue test) in both supine and sitting
positions appropriate to the specific lumbar nerve root that is
compromised. (See 1.00C2 for guidance on interpreting information
from a physical examination report.)
G. What do we consider when we evaluate lumbar spinal stenosis
resulting in compromise of the cauda equina (1.16)?
1. We consider the limiting effects of pain, sensory changes,
and muscle weakness caused by compromise of the cauda equina due to
lumbar spinal stenosis. The cauda equina is a bundle of nerve roots
that descends from the lower part of the spinal cord. Lumbar spinal
stenosis can compress the nerves of the cauda equina, causing
sensory changes and muscle weakness that may affect your ability to
stand or walk. Pain related to compromise of the cauda equina is
``nonradicular,'' because it is not typically associated with a
specific nerve root (as is radicular pain in the cervical or lumbar
spine).
2. Compromise of the cauda equina due to spinal stenosis can
affect your ability to walk because of neurogenic claudication (also
known as pseudoclaudication), a disorder usually causing non-
radicular pain that starts in the low back and radiates bilaterally
(or less commonly, unilaterally) into the buttocks and lower
extremities (or extremity). Extension of the lumbar spine, as when
walking or merely standing, provokes the pain of neurogenic
claudication. It is relieved by forward flexion of the lumbar spine
or by sitting. In contrast, the leg pain associated with peripheral
vascular claudication results from inadequate arterial blood flow to
a lower extremity. It occurs repeatedly and consistently when a
person walks a certain distance and is relieved when the person
rests.
H. What do we consider when we evaluate reconstructive surgery
or surgical arthrodesis of a major weight-bearing joint (1.17)?
1. We consider reconstructive surgery or surgical arthrodesis
when an acceptable medical source(s) documents the surgical
procedure(s) and associated medical treatments to restore function
of the affected body part(s). The reconstructive surgery may be a
single event or it may be a series of procedures directed toward the
salvage or restoration of functional use of the affected joint.
2. Major weight-bearing joints. The major weight-bearing joints
are the hip, knee, and ankle-foot. The ankle and foot are considered
together as one major joint.
3. Surgical arthrodesis. Surgical arthrodesis is the artificial
fusion of the bones that form a joint, essentially eliminating the
joint.
I. What do we consider when we evaluate abnormality of a major
joint(s) in any extremity (1.18)?
1. General. We consider musculoskeletal disorders that produce
anatomical abnormalities of major joints of the extremities,
resulting in functional abnormalities in the upper or lower
extremities (for example, osteoarthritis and chronic infections of
bones and joints, surgical arthrodesis of a joint). Major joint of
an upper extremity refers to the shoulder, elbow, and wrist-hand. We
consider the wrist and hand together as one major joint. Major joint
of a lower extremity refers to the hip, knee, and ankle-foot. We
consider the ankle and hindfoot together as one major joint, because
it is necessary for walking. Abnormalities affecting the joints may
include ligamentous laxity or rupture, soft tissue contracture, or
tendon rupture, and can cause muscle weakness of the affected body
part.
2. How do we define abnormality in the extremities? An
anatomical abnormality in any extremity(ies) is one that is readily
observable by a medical source during a physical examination (for
example, subluxation or contracture), or is present on imaging (for
example, ankylosis, bony destruction, joint space narrowing, or
deformity). A functional abnormality is abnormal motion or
instability of the affected part(s), including limitation of motion,
excessive motion (hypermobility), movement outside the normal plane
of motion for the joint (for example, lateral deviation), or
fixation of the affected parts.
J. What do we consider when we evaluate pathologic fractures due
to any cause (1.19)?

[[Page 20662]]

We consider pathologic fractures of the bones in the skeletal spine,
extremities, or other parts of the skeletal system. Pathologic
fractures result from disorders that weaken the bones, making them
vulnerable to breakage. For non-healing or complex traumatic
fractures without accompanying pathology, see 1.22 Non-healing or
complex fracture of the femur, tibia, pelvis, or one or more of the
tarsal bones or 1.23 Non-healing or complex fracture of an upper
extremity. Pathologic fractures may occur with osteoporosis,
osteogenesis imperfecta or any other skeletal dysplasias, side
effects of medications, and disorders of the endocrine or other body
systems. They must occur on separate, distinct occasions, rather
than multiple fractures occurring at the same time, but they may
affect the same bone(s) multiple times. There is no required period
between the incidents of fracture(s), but they must all occur within
a 12-month period; for example, separate incidents may occur within
hours or days of each other. However, the associated limitation(s)
of function must last, or be expected to last, at least 12 months.
K. What do we consider when we evaluate amputation due to any
cause (1.20)?
1. General. We consider amputation (the full or partial loss or
absence of any extremity) due to any cause, including trauma,
congenital abnormality or absence, surgery for treatment of
conditions such as cancer or infection, or complications of
peripheral vascular disease or diabetes mellitus.
2. Amputation of both upper extremities (1.20A). Upper extremity
amputations, for the purposes of this listing, may occur at any
level above the wrists (carpal joints), up to and including
disarticulation of the shoulder (glenohumeral) joint. We do not
evaluate amputations below the wrists under this listing, because
the resulting limitation of function of the thumb(s), finger(s), or
hand(s) will vary, depending on the extent of loss and corresponding
effect on fine and gross movements (see 1.00E3). For amputations
below the wrist, we will follow the remaining steps of the
sequential evaluation process (see Sec. Sec. 404.1520 and 416.920
of this chapter).
3. Hemipelvectomy or hip disarticulation (1.20B). Hemipelvectomy
involves amputation of an entire lower extremity through the
sacroiliac joint. Hip disarticulation involves amputation of an
entire lower extremity through the hip joint capsule and closure of
the remaining musculature over the exposed acetabular bone.
4. Amputation of one upper extremity at any level above the
wrist and one lower extremity at or above the ankle (1.20C). We
evaluate the absence of one upper extremity and one lower extremity
with regard to whether you have a documented medical need (see
1.00C6a) for a one-handed assistive device (see 1.00C6d), such as a
cane or crutch. In this situation, you may wear a prosthesis (see
1.00C6b) on your lower extremity, but nevertheless have a documented
medical need for a one-handed assistive device. If you do, you would
need to use your other upper extremity to hold the assistive device,
making the extremity unavailable to perform other fine and gross
movements (see 1.00E3) such as carrying. In such a case, your
disorder would meet this listing.
5. Amputation of one or both lower extremities at or above the
ankle (tarsal joint) (1.20D). When we evaluate amputations of one or
both lower extremities:
a. We consider the condition of your residual limb(s), and
whether you can wear a prosthesis(es) (see 1.00C6b). When you have a
prosthesis(es), we will examine your residual limb with the
prosthesis(es) in place. If you are unable to use a prosthesis(es)
because of residual limb complications that have lasted, or are
expected to last, for at least 12 months, and you are not currently
undergoing surgical management (see 1.00L) of your condition, we
evaluate your disorder under this listing.
b. Under 1.20D ``Amputation of one or both lower extremities at
or above the ankle (tarsal joint),'' we consider whether you have a
documented medical need (see 1.00C6a) for a hand-held assistive
device(s) (1.00C) and your ability to walk with the device(s).
c. If you have a non-healing residual limb(s) and are receiving
ongoing surgical treatment expected to re-establish or improve
function, and that ongoing surgical treatment has not ended, or is
not expected to end, within at least 12 months of the initiation of
the surgical management (see 1.00L1), we evaluate your disorder
under 1.21 Soft tissue injury or abnormality under continuing
surgical management.
L. What do we consider when we evaluate soft tissue injuries or
abnormalities under continuing surgical management (1.21)?
1. General.
a. We consider any soft tissue injury or abnormality involving
the soft tissues of the body, whether congenital or acquired, when
an acceptable medical source(s) documents the need for ongoing
surgical procedures and associated medical treatments to restore
function of the affected body part(s). Surgical management includes
the surgery(-ies) itself, as well as various post-surgical
procedures, surgical complications, infections or other medical
complications, related illnesses, or related treatments that delay a
person's attainment of maximum benefit from surgery.
b. Surgical procedures and associated treatments typically take
place over extended periods, which may render you unable to perform
work-related activity on a sustained basis. To document such
inability, we must have evidence from an acceptable medical
source(s) confirming that the surgical management has continued, or
is expected to continue, for at least 12 months from the date of the
first surgical intervention. These procedures and treatments must be
directed toward saving, reconstructing, or replacing the affected
part of the body to re-establish or improve its function, and not
for cosmetic appearances alone.
c. Examples include malformations, third and fourth degree
burns, crush injuries, craniofacial injuries, avulsive injuries, and
amputations with complications of the residual limb(s).
d. We evaluate skeletal spine abnormalities or injuries under
1.15 Disorders of the skeletal spine resulting in compromise of a
nerve root(s), or 1.16 Lumbar spinal stenosis resulting in
compromise of the cauda equina, as appropriate. We evaluate
abnormalities or injuries of bones in the lower extremities under
1.17 Reconstructive surgery or surgical arthrodesis of a major
weight-bearing joint, 1.18 Abnormality of a major joint(s) in any
extremity, or 1.22 Non-healing or complex fracture of the femur,
tibia, pelvis, or one or more of the tarsal bones. We evaluate
abnormalities or injuries of bones in the upper extremities under
1.18 Abnormality of a major joint(s) in any extremity, or 1.23 Non-
healing or complex fracture of an upper extremity.
2. Documentation. In addition to the objective medical evidence
we need to establish your soft tissue injury or abnormality, we also
need all of the following medically documented evidence about your
continuing surgical management:
a. Operative reports and related laboratory findings;
b. Records of post-surgical procedures;
c. Records of any surgical or medical complications (for
example, related infections or systemic illnesses);
d. Records of any prolonged post-operative recovery periods and
related treatments (for example, surgeries and treatments for
burns);
e. An acceptable medical source's plans for additional
surgeries; and
f. Records detailing any other factors that have delayed, or
that an acceptable medical source expects to delay, the saving,
restoring, or replacing of the involved part for a continuous period
of at least 12 months following the initiation of the surgical
management.
3. Burns. Third- and fourth-degree burns damage or destroy nerve
tissue, reducing or preventing transmission of signals through those
nerves. Such burns frequently require multiple surgical procedures
and related therapies to re-establish or improve function, which we
evaluate under 1.21 Soft tissue injury or abnormality under
continuing surgical management. When burns are no longer under
continuing surgical management, we evaluate the residual
impairment(s) (see 1.00O). When the residual impairment(s) affects
the musculoskeletal system, as often occurs in third and fourth
degree burns, it can result in permanent musculoskeletal tissue
loss, joint contractures, or loss of extremities. We will evaluate
such impairments under the relevant musculoskeletal listing(s), for
example, 1.18 Abnormality of a major joint(s) in any extremity or
1.20 Amputation due to any cause. When the residual impairment(s)
involves another body system(s), we will evaluate the impairment(s)
under the relevant body system listing (for example, 8.08 Burns).
4. Craniofacial injuries. Surgeons may treat craniofacial
injuries with multiple surgical procedures. These injuries may
affect vision, hearing, speech, and the initiation of the digestive
process, including mastication. When the craniofacial injury-related
residual impairment(s) involves another body system(s), we will
evaluate the impairment(s) under the relevant body system listings.
See 1.00O regarding evaluation of residual impairment(s).
M. What do we consider when we evaluate non-healing or complex
fractures of the

[[Page 20663]]

femur, tibia, pelvis, or one or more of the tarsal bones (1.22)?
1. We evaluate a non-healing (nonunion) or complex fracture of
the femur, tibia, pelvis, or one or more of the tarsal bones with
regard to whether you have a documented medical need (see 1.00C6a)
for a bilateral (two-handed) assistive device (see 1.00C6d), such as
a walker or bilateral crutches.
2. Non-healing fracture. A non-healing fracture is a fracture
that has failed to unite completely. Nonunion is usually established
when a minimum of 9 months has elapsed since the injury and the
fracture site has shown no progressive signs of healing for a
minimum of 3 months.
3. Complex fracture. A fracture is complex when one or more of
the following occur:
a. Comminuted (broken into many pieces) bone fragments,
b. Multiple fractures in a single bone,
c. Bone loss due to severe trauma,
d. Damage to the surrounding soft tissue,
e. Severe cartilage damage to the associated joint, or
f. Dislocation of the associated joint.
4. When a complex fracture involves soft tissue damage, the
treatment may involve continuing surgical management to restore or
improve functioning. In such cases, we may evaluate the fracture(s)
under 1.21 Soft tissue injury or abnormality under continuing
surgical management.
N. What do we consider when we evaluate non-healing or complex
fractures of an upper extremity (1.23)?
1. We evaluate a non-healing (nonunion) or complex fracture of
an upper extremity under continuing surgical management (see
1.00L1a) with regard to whether you have an inability to use both
upper extremities to independently initiate, sustain, and complete
fine and gross movements.
2. Non-healing fracture. A non-healing fracture is a fracture
that has failed to unite completely. Nonunion is usually established
when a minimum of 9 months have elapsed since the injury and the
fracture site has shown no progressive signs of healing for a
minimum of 3 months.
3. Complex fracture. A fracture is complex when one or more of
the following occur:
a. Comminuted (broken into many pieces) bone fragments,
b. Multiple fractures in a single bone,
c. Bone loss due to severe trauma,
d. Damage to the surrounding soft tissue,
e. Severe cartilage damage to the associated joint, or
f. Dislocation of the associated joint.
O. How do we determine when your soft tissue injury or
abnormality or your upper extremity fracture is no longer under
continuing surgical management or you have received maximum
therapeutic benefit?
1. Your soft tissue injury or abnormality or your upper
extremity fracture is no longer under continuing surgical management
when the last surgical procedure or medical treatment directed
toward the re-establishment or improvement of function of the
involved part has occurred. We will find that you have received
maximum therapeutic benefit from treatment if there are no
significant changes in physical findings or on appropriate imaging
for any 6-month period after the last surgical procedure or medical
treatment. We may also find that you have received maximum
therapeutic benefit if your medical source(s) indicates that further
improvement is not expected after the last surgical procedure or
medical treatment.
2. When you have received maximum therapeutic benefit from
treatment, we will evaluate any impairment-related residual
symptoms, signs, and laboratory findings (including those on
imaging), any complications associated with your surgical procedures
or medical treatments, and any residual limitations in your
functioning. Depending upon all of those factors, we may find that
your musculoskeletal impairment is no longer severe.
3. If your impairment(s) remains severe, we will evaluate your
residual limitations and all other impairment-related factors to
determine whether your musculoskeletal disorder meets or medically
equals another listing. If it does not, we will follow the remaining
steps of the sequential evaluation process to determine whether you
have the residual functional capacity (RFC) to engage in substantial
gainful activity. If your impairment involves burns and remains
severe, we will follow the above sequence by evaluating your
impairment as described in 1.00L3.
P. How do we evaluate the severity and duration of your
established musculoskeletal disorder when there is no record of
ongoing treatment?
1. You may not have received ongoing treatment or may not have
an ongoing relationship with the medical community despite having a
musculoskeletal disorder(s). In either of these situations, you will
not have a longitudinal medical record for us to review when we
evaluate your disorder. We may therefore ask you to attend a
consultative examination to determine the severity and potential
duration of your disorder (see Sec. Sec. 404.1519a(b) and
416.919a(b) of this chapter).
2. In some instances, we may be able to assess the severity and
duration of your musculoskeletal disorder based on your medical
record and current evidence alone. If the information in your case
record is not sufficient or appropriate to show that you have a
musculoskeletal disorder that meets the criteria of one of the
musculoskeletal disorders listings, we will follow the rules in
1.00R.
Q. How do we evaluate substance use disorders that co-exist with
a musculoskeletal disorder?
If we find that you are disabled and there is medical evidence
in your case record establishing that you have a substance use
disorder that co-exists with your musculoskeletal disorder, we will
determine whether your substance use disorder is a contributing
factor material to the determination of disability (see Sec. Sec.
404.1535 and 416.935 of this chapter).
R. How do we evaluate disorders that do not meet one of the
musculoskeletal listings?
1. These listings are only examples of musculoskeletal disorders
that we consider severe enough to prevent your ability to engage in
any gainful activity. If your musculoskeletal disorder(s) does not
meet the criteria of any of these listings, we will consider whether
you have an impairment(s) that meets the criteria of a listing in
another body system.
2. If you have a severe medically determinable impairment(s)
that does not meet any listing, we will determine whether your
impairment(s) medically equals a listing. See Sec. Sec. 404.1526
and 416.926 of this chapter. If it does not medically equal a
listing, we will assess your RFC. See Sec. Sec. 404.1545 and
416.945 of this chapter. To assess your RFC, we may require evidence
in addition to, or different from, the types of evidence that we use
to determine whether your impairment(s) meets or medically equals a
listing. We will use the assessment of your RFC to evaluate your
claim at the fourth, and if necessary, the fifth step of the
sequential evaluation process to determine whether you can perform
your past work or adjust to any other work, respectively. See
Sec. Sec. 404.1520 and 416.920 of this chapter.
3. We use the rules in Sec. Sec. 404.1594 and 416.994 of this
chapter, as appropriate, when we decide whether you continue to be
disabled.

1.01 Category of Impairments, Musculoskeletal Disorders

1.15 Disorders of the skeletal spine resulting in compromise of
a nerve root(s) (see 1.00F), documented by A, B, C, and D:
A. Symptom(s) of neuro-anatomic (radicular) distribution of one
or more of the following manifestations consistent with compromise
of the affected nerve root(s):
1. Pain; or
2. Paresthesias; or
3. Muscle fatigue.

AND

B. Radicular neurological signs present during physical
examination or testing and evidenced by 1, 2, and 4; or 1, 3, and 4
below:
1. Muscle weakness; and
2. Sensory changes evidenced by:
a. Decreased sensation; or
b. Sensory nerve deficit (abnormal sensory nerve latency) on
electrodiagnostic testing; or
3. Decreased deep tendon reflexes; and
4. Sign(s) of nerve root irritation, tension, or compression,
consistent with compromise of the affected nerve root (see 1.00F2).

AND

C. Findings on imaging consistent with compromise of a nerve
root(s) in the cervical or lumbosacral spine (see 1.00C3).

AND

[[Page 20664]]

3. An inability to use both upper extremities to the extent that
neither can be used to independently initiate, sustain, and complete
work-related activities involving fine and gross movements.
1.16 Lumbar spinal stenosis resulting in compromise of the cauda
equina (see 1.00G), documented by A, B, C, and D:
A. Symptoms of neurological compromise, such as pain, manifested
as:
1. Nonradicular distribution of pain in one or both lower
extremities; or
2. Nonradicular distribution of sensory loss in one or both
extremities; or
3. Neurogenic claudication.

AND

B. Nonradicular neurological signs present during physical
examination or testing and evidenced by 1 and 2, or 1 and 3, below:
1. Muscle weakness; and
2. Sensory changes evidenced by:
a. Decreased sensation; or
b. Sensory nerve deficit (abnormal sensory nerve latency) on
electrodiagnostic testing; or
c. Areflexia, trophic ulceration, or bladder or bowel
incontinence.
3. Decreased deep tendon reflexes in one or both lower
extremities.

AND

C. Findings on imaging or in an operative report consistent with
compromise of the cauda equina with lumbar spinal stenosis.

AND

D. Impairment-related physical limitation of musculoskeletal
functioning that has lasted, or can be expected to last, for a
continuous period of at least 12 months, and medical documentation
of at least one of the following (see 1.00E):
1. A documented medical need for a walker, bilateral canes, or
bilateral crutches; or
2. An inability to use one upper extremity to independently
initiate, sustain, and complete work-related activities involving
fine and gross movements, and a documented medical need for a one-
handed assistive device that requires the use of the other upper
extremity.
1.17 Reconstructive surgery or surgical arthrodesis of a major
weight-bearing joint (see 1.00H), documented by A, B, and C:
A. Documented history of reconstructive surgery or surgical
arthrodesis of a major weight-bearing joint.

AND

B. Impairment-related physical limitation of musculoskeletal
functioning that has lasted, or can be expected to last, for a
continuous period of at least 12 months.

AND

C. A documented medical need for a walker, bilateral canes, or
bilateral crutches (see 1.00E).
1.18 Abnormality of a major joint(s) in any extremity (see
1.00I), documented by A, B, C, and D:
A. Chronic joint pain or stiffness.

AND

B. Abnormal motion, instability, or immobility of the affected
joint(s).

AND

C. Anatomical abnormality of the affected joint(s) noted on:
1. Physical examination (for example, subluxation, contracture,
bony or fibrous ankylosis); or
2. Imaging (for example, joint space narrowing, bony
destruction, or ankylosis or arthrodesis of the affected joint).

AND

D. Impairment-related physical limitation of musculoskeletal
functioning that has lasted, or can be expected to last, for a
continuous period of at least 12 months, and medical documentation
of at least one of the following (see 1.00E):
1. A documented medical need for a walker, bilateral canes, or
bilateral crutches; or
2. An inability to use one upper extremity to independently
initiate, sustain, and complete work-related activities involving
fine and gross movements, and a documented medical need for a one-
handed assistive device that requires the use of the other upper
extremity; or
3. An inability to use both upper extremities to the extent that
neither can be used to independently initiate, sustain, and complete
work-related activities involving fine and gross movements.
1.19 Pathologic fractures due to any cause (see 1.00J),
documented by A and B:
A. Three or more medically documented pathologic fractures
occurring on separate occasions within a 12-month period;

AND

B. Impairment-related physical limitation of musculoskeletal
functioning that has lasted, or can be expected to last, for a
continuous period of at least 12 months, and medical documentation
of at least one of the following (see 1.00E):
1. A documented medical need for a walker, bilateral canes, or
bilateral crutches; or
2. An inability to use one upper extremity to independently
initiate, sustain, and complete work-related activities involving
fine and gross movements, and a documented medical need for a one-
handed assistive device that requires the use of the other upper
extremity; or
3. An inability to use both upper extremities to the extent that
neither can be used to independently initiate, sustain, and complete
work-related activities involving fine and gross movements.
1.20 Amputation due to any cause (see 1.00K), documented by A,
B, C, or D:
A. Amputation of both upper extremities, occurring at any level
above the wrists (carpal joints), up to and including the shoulder
(glenohumeral) joint.

B. Hemipelvectomy or hip disarticulation.

C. Amputation of one upper extremity, occurring at any level
above the wrist (carpal joints), and one lower extremity at or above
the ankle (tarsal joint), and medical documentation of one the
following (see 1.00E):
1. The documented medical need for a one-handed assistive device
requiring the use of the other upper extremity; or
2. The inability to use the remaining upper extremity to
independently initiate, sustain, and complete work-related
activities involving fine and gross movements.

D. Amputation of one or both lower extremities at or above the
ankle (tarsal joint), with complications of the residual limb that
have lasted or can be expected to last for at least 12 months, and
medical documentation of both 1 and 2 (see 1.00E):
1. The inability to use a prosthetic device(s); and
2. The documented medical need for a walker, bilateral canes, or
bilateral crutches.
1.21 Soft tissue injury or abnormality under continuing surgical
management (see 1.00L), documented by A, B, and C in the medical
record:
A. Evidence confirms ongoing surgical management directed
towards saving, reconstructing, or replacing the affected part of
the body.

AND

B. The surgical management has been, or is expected to be,
ongoing for at least 12 months.

AND

C. Maximum benefit from therapy has not yet been achieved.
1.22 Non-healing or complex fracture of the femur, tibia,
pelvis, or one or more of the tarsal bones (see 1.00M), documented
by A and B and C:
A. Solid union not evident on appropriate medically acceptable
imaging and not clinically solid;

AND

B. Impairment-related physical limitation of musculoskeletal
functioning that has lasted, or can be expected to last, for a
continuous period of at least 12 months,

AND

C. Medical documentation of medical need for a walker, bilateral
canes, or bilateral crutches (see 1.00E).
1.23 Non-healing or complex fracture of an upper extremity (see
1.00N), documented by A and B and C:
A. Nonunion of a fracture, or complex fracture of the shaft of
the humerus, radius, or ulna, under continuing surgical management,
as defined in 1.00O, directed toward restoration of functional use
of the extremity;

AND

B. Impairment-related physical limitation of musculoskeletal
functioning that has lasted, or can be expected to last, for a
continuous period of at least 12 months;

AND

C. Medical documentation of at least one of the following (see
1.00E):
1. An inability to use one upper extremity to independently
initiate, sustain, and complete work-related activities involving
fine and gross movements, and a documented medical need for a one-
handed assistive device that requires the use of the other upper
extremity; or
2. An inability to use both upper extremities to the extent that
neither can be used to independently initiate, sustain, and

[[Page 20665]]

complete work-related activities involving fine and gross movements.
* * * * *

4.00 CARDIOVASCULAR SYSTEM

* * * * *
G. Evaluating Peripheral Vascular Disease
* * * * *
4. What is lymphedema and how will we evaluate it?
* * * * *
b. * * * We will evaluate lymphedema by considering whether the
underlying cause meets or medically equals any listing or whether
the lymphedema medically equals a cardiovascular listing, such as
4.11 Chronic venous insufficiency, or a musculoskeletal listing,
such as 1.18 Abnormality of a major joint(s) in any extremity. * * *
* * * * *

14.00 IMMUNE SYSTEM DISORDERS

* * * * *
C. Definitions
* * * * *
2. Assistive device(s) has the same meaning as in 1.00C6a.
* * * * *
5. Documented medical need has the same meaning as in 1.00C6a.
* * * * *
8. Fine and gross movements has the same meaning as in 1.00E3.
9. Hand-held assistive device has the same meaning as in
1.00C6d.
10. Major joint of an upper or lower extremity has the same
meaning as in 1.00I1.
* * * * *
D. How do we document and evaluate the listed autoimmune
disorders?
* * * * *
4. Polymyositis and dermatomyositis (14.05).
* * * * *
c. * * *
(i) Weakness of your pelvic girdle muscles that results in your
inability to rise independently from a squatting or sitting position
or to climb stairs may be an indication that you are unable to walk
without physical or mechanical assistance. * * *
* * * * *
d. * * *
6. * * *
a. General. * * * Clinically, inflammation of major joints in an
upper or lower extremity may be the dominant manifestation causing
difficulties with walking or performing fine and gross movements;
there may be joint pain, swelling, and tenderness. The arthritis may
affect other joints, or cause less limitation in walking or
performing fine and gross movements. * * *
* * * * *
e. * * *
(i) Listing-level severity in 14.09 Inflammatory arthritis is
shown by the presence of an impairment-related, significant
limitation cited in the criteria of these listings. In 14.09A,
listing-level severity is satisfied with persistent inflammation or
deformity in one major joint in a lower extremity resulting in a
documented medical need for a walker, bilateral canes, or bilateral
crutches as required in 14.09A1, or one major joint in each upper
extremity resulting in an impairment-related, significant limitation
in the ability to perform fine and gross movements as required in
14.09A2. In 14.09C1, if you have the required ankylosis (fixation)
of your cervical or dorsolumbar spine, we will find that you have an
impairment-related significant limitation in your ability to see in
front of you, above you, and to the side. Therefore, a listing-level
impairment in the ability to walk is implicit in 14.09C1, even
though you might not require bilateral upper limb assistance.
(ii) Listing-level severity is shown in 14.09B, 14.09C2, and
14.09D by inflammatory arthritis that involves various combinations
of complications of one or more major joints in an upper or lower
extremity or other joints, such as inflammation or deformity, extra-
articular features, repeated manifestations, and constitutional
symptoms or signs. * * *
* * * * *
14.04 Systemic sclerosis (scleroderma). As described in 14.00D3.
With:
* * * * *
B. One of the following:
1. Toe contractures or fixed deformity of one or both feet,
resulting in one of the following:
a. A documented medical need for a walker, bilateral canes, or
bilateral crutches (see 14.00C9); or
b. An inability to use one upper extremity to independently
initiate, sustain, and complete work-related activities involving
fine and gross movements, and a documented medical need for a one-
handed assistive device (see 14.00C9) that requires the use of the
other upper extremity; or
2. Finger contractures or fixed deformity in both hands,
resulting in an inability to use both upper extremities to the
extent that neither can be used to independently initiate, sustain,
and complete work-related activities involving fine and gross
movements; or
3. Atrophy with irreversible damage in one or both lower
extremities, resulting in one of the following:
a. A documented medical need for a walker, bilateral canes, or
bilateral crutches (see 14.00C9); or
b. An inability to use one upper extremity to independently
initiate, sustain, and complete work-related activities involving
fine and gross movements, and a documented medical need for a one-
handed assistive device (see 14.00C9) that requires the use of the
other upper extremity; or
4. Atrophy with irreversible damage in both upper extremities,
resulting in an inability to use both upper extremities to the
extent that neither can be used to independently initiate, sustain,
and complete work-related activities involving fine and gross
movements.

C. Raynaud's phenomenon, characterized by:
* * * * *
2. Ischemia with ulcerations of toes or fingers, resulting in
one of the following:
a. A documented medical need for a walker, bilateral canes, or
bilateral crutches (see 14.00C9); or
b. An inability to use one upper extremity to independently
initiate, sustain, and complete work-related activities involving
fine and gross movements, and a documented medical need for a one-
handed assistive device (see 14.00C9) that requires the use of the
other upper extremity; or
c. An inability to use both upper extremities to the extent that
neither can be used to independently initiate, sustain, and complete
work-related activities involving fine and gross movements.
* * * * *
14.05 Polymyositis and dermatomyositis. As described in 14.00D4.
With:
A. Proximal limb-girdle (pelvic or shoulder) muscle weakness,
resulting in one of the following:
1. A documented medical need for a walker, bilateral canes, or
bilateral crutches (see 14.00C9); or
2. An inability to use one upper extremity to independently
initiate, sustain, and complete work-related activities involving
fine and gross movements, and a documented medical need for a one-
handed assistive device (see 14.00C9) that requires the use of the
other upper extremity; or
3. An inability to use both upper extremities to the extent that
neither can be used to independently initiate, sustain, and complete
work-related activities involving fine and gross movements.
* * * * *
14.09 Inflammatory arthritis. As described in 14.00D6. With:
A. Persistent inflammation or persistent deformity of:
1. One or more major joints in a lower extremity(ies) resulting
in one of the following:
a. A documented medical need for a walker, bilateral canes, or
bilateral crutches (see 14.00C9); or
b. An inability to use one upper extremity to independently
initiate, sustain, and complete work-related activities involving
fine and gross movements, and a documented medical need for a one-
handed assistive device (see 14.00C9) that requires the use of the
other upper extremity; or
2. One or more major joints in each upper extremity resulting in
an inability to use both upper extremities to the extent that
neither can be used to independently initiate, sustain, and complete
work-related activities involving fine and gross movements.

B. Inflammation or deformity in one or more major joints of an
upper or lower extremity(ies) with: * * *
* * * * *

Part B

* * * * *
101.00 Musculoskeletal Disorders.
* * * * *

101.00 Musculoskeletal Disorders

A. Which disorders do we evaluate under these listings?

[[Page 20666]]

1. We evaluate disorders of the skeletal spine (vertebral
column) or of the upper or lower extremities that affect
musculoskeletal functioning in the musculoskeletal body system
listings. We use the term ``skeletal'' when we are referring to the
structure of the bony skeleton. The skeletal spine refers to the
bony structures, ligaments, and discs making up the spine. We refer
to the ``skeletal'' spine in some musculoskeletal listings to
differentiate it from the neurological spine (see 101.00B1).
Disorders may be congenital or acquired, and may include
deformities, amputations, or other musculoskeletal abnormalities.
These disorders may involve the bones or major joints; or the
tendons, ligaments, muscles, or other soft tissues.
2. We also evaluate soft tissue abnormalities or injuries
(including burns) that are under continuing surgical management (see
101.00L). The abnormalities or injuries may affect any part of the
body, including the face and skull.
B. Which related disorders do we evaluate under other listings?
1. We evaluate a disorder or injury of the skeletal spine that
results in damage to, and neurological dysfunction of, the spinal
cord and its associated nerves (for example, paraplegia or
quadriplegia) under the criteria in 111.00 Neurological Disorders.
2. We evaluate inflammatory arthritis (for example, rheumatoid
arthritis) under the criteria in 114.00 Immune System Disorders.
3. We evaluate curvatures of the skeletal spine under these
musculoskeletal disorders listings and other listings as appropriate
for the affected body system. Curvatures of the skeletal spine that
affect musculoskeletal functioning are evaluated under 101.15
Disorders of the skeletal spine resulting in compromise of a nerve
root(s). If a curvature of the skeletal spine is under continuing
surgical management, we can evaluate it for medical equivalence to
101.21 Soft tissue injury or abnormality under continuing surgical
management. Skeletal curvatures may also adversely affect
functioning in body systems other than the musculoskeletal system.
For example, the curvature may interfere with your ability to
breathe (see 103.00 Respiratory Disorders); there may be impaired
myocardial function (see 104.00 Cardiovascular System); or there may
be disfigurement resulting in social withdrawal or depression (see
112.00 Mental Disorders).
4. We evaluate non-healing or pathological fractures due to
cancer, whether it is a primary site or metastases, under the
criteria in 113.00 Cancer (Malignant Neoplastic Diseases).
5. We evaluate the leg pain associated with peripheral vascular
claudication under the criteria in 104.00 Cardiovascular System.
6. We evaluate burns that do not require continuing surgical
management under the criteria in 108.00 Skin Disorders.
C. What evidence do we need to evaluate your musculoskeletal
disorder under these listings?
1. General. To establish the presence of a musculoskeletal
disorder as a medically determinable impairment, we need objective
medical evidence from an acceptable medical source who has examined
you for the disorder. To assess the severity and duration of your
disorder, we evaluate evidence from both medical and nonmedical
sources who can describe how you function. If there is no record of
ongoing medical treatment for your disorder, we will follow the
guidelines in 101.00Q How do we evaluate the severity and duration
of your established musculoskeletal disorder when there is no record
of ongoing treatment? We will determine the extent and kinds of
evidence we need from medical and non-medical sources based on the
individual facts about your disorder. For our basic rules on
evidence, see Sec. Sec. 416.902, 416.912, 416.913, 416.913a, and
416.920b of this chapter. For our rules on evidence about your
symptoms, see Sec. 416.929 of this chapter.
2. Physical examination report(s). In the report(s) of your
physical examination, we need a detailed description of the
orthopedic, neurologic, or other objective clinical findings
appropriate to your specific musculoskeletal disorder. We require
objective clinical findings from the medical source's direct
observations during your physical examination, not simply his or her
report of your statements about your symptoms and limitations. When
the medical source reports that a clinical test sign(s) is positive,
unless we have evidence to the contrary, we will assume that he or
she performed the test properly. For instance, we will assume a
straight-leg raising test was conducted properly, i.e., in a sitting
and supine position, even if the medical source does not specify the
positions in which the test was performed. In the absence of
evidence to the contrary, we will accept the medical source's
interpretation of the test. If you use an assistive device (see
101.00C6), the report must support the medical need for the device.
If reduction in muscle strength is a factor, we require medical
documentation of measurement of the strength of the muscle(s) in
question, generally based on a grading system of 0 to 5. Zero (0)
indicates complete loss of strength and 5 indicates maximum
strength, consistent with Table 1 below. The documentation should
also include measurements of grip and pinch strength, if there is
evidence of involvement of one or both hands.

Table 1
------------------------------------------------------------------------

3. Laboratory findings: Imaging and other diagnostic tests
a. Imaging refers to medical imaging techniques, such as x-ray,
computed tomography (CT), magnetic resonance imaging (MRI), and
radionuclide scanning. For the purpose of these listings, the
imaging technique(s) must be consistent with the generally accepted
standards of medical knowledge and clinical practice.
b. Findings on imaging must have lasted, or must be expected to
last, for a continuous period of at least 12 months.
c. Imaging and other diagnostic tests can provide evidence of
physical abnormalities; however, they may correlate poorly with your
symptoms, including pain, or with your musculoskeletal functioning.
Accordingly, we cannot use such tests as a substitute for physical
examination findings about your ability to function, nor can we
infer severity or functional limitations based solely on such tests.
d. For our policies about when we will purchase imaging and
other diagnostic tests, see Sec. Sec. 416.919k and 416.919m of this
chapter.
4. Operative reports. If you have had a surgical procedure(s),
we need either the operative reports, including details of the
findings at surgery and information about any medical complications
that may have occurred, or confirmatory evidence of the surgical
procedure(s) from a medical source (for example, detailed follow-up
reports or notations in the medical records concerning your past
medical history).
5. Effects of treatment
a. General. Treatments for musculoskeletal disorders may have
beneficial or adverse effects, and responses to treatment vary from
person to person. We will evaluate all of the effects of treatment
(including surgical treatment, medications, and therapy) on the
symptoms, signs, and laboratory findings of your musculoskeletal
disorder, and on your musculoskeletal functioning.
b. Response to treatment. To evaluate your musculoskeletal
functioning in response to treatment, we need specific information
related to your impairment, including the following: A description
of your medications, including frequency of administration; the type
and frequency of therapy you receive; and a description of your
response to treatment and any complications you experience related
to your impairment. The effects of treatment may be temporary or
long-term. We need information over a sufficient period to determine
the effect of

[[Page 20667]]

treatment on your current musculoskeletal functioning and to permit
reasonable projections about your future functioning. In some cases,
we will need additional evidence to make an assessment about your
response to treatment. Depending upon the timing of this treatment
in relation to the alleged onset date of disability, we may need to
defer evaluation of the impairment for a period of up to 3 months
from the date treatment began to permit consideration of treatment
effects, unless we can make a determination or decision using the
evidence we have.
6. Assistive devices
a. General. An assistive device, for the purposes of these
listings, is any device that is used to improve stability,
dexterity, or mobility. An assistive device can be worn (see
101.00C6b and c), or hand-held (see 101.00C6d). If you use any type
of assistive device(s), we need evidence from a medical source
regarding the documented medical need for the device(s). When we use
the term ``documented medical need,'' we mean that there is evidence
from a medical source(s) in the medical record that supports your
need for an assistive device (see Sec. 416.913 of this chapter).
The evidence must include documentation from a medical source(s)
describing any limitation(s) in your upper or lower extremity
functioning that supports your need for the assistive device, and
supporting the circumstances for which you need it. The evidence
does not have to include a specific prescription for the device.
b. Prosthesis(es). A prosthesis is a wearable device, such as an
artificial limb, that takes the place of an absent body part. We
need evidence from a medical source documenting your ability to
walk, or to perform fine and gross movements (see 101.00E4), with
the prosthesis(es) in place. When amputation(s) involves a lower
extremity or extremities, it is not necessary to evaluate your
ability to walk without the prosthesis(es) in place. If you cannot
use your prosthesis(es) due to complications affecting your residual
limb(s), we need documentation from a medical source regarding the
condition of your residual limb(s) and the medical basis for your
inability to use the prosthesis(es).
c. Orthosis(es). An orthosis is a wearable device that prevents
or corrects a dysfunction or deformity by aligning or supporting the
affected body part. An orthosis may also be referred to as a
``brace.'' If you have an orthosis(es), we need evidence from a
medical source documenting your ability to walk, or to perform fine
and gross movements, with the orthosis(es) in place. If you cannot
use your orthosis(es), we need evidence from a medical source
documenting the medical basis for your inability to use the
device(s).
d. Hand-held assistive devices. Hand-held assistive devices
include canes, crutches, or walkers, and are carried in your hand(s)
to support or aid you in walking. When you require a one-handed
assistive device for ambulation, such as a cane or single crutch,
and your other upper extremity has limitations preventing its use
for fine or gross movement(s) (see 101.00E4), the need for the
assistive device limits the use of both upper extremities. If you
use a hand-held assistive device, we need evidence from a medical
source documenting your need for the device(s) and describing how
you walk with the device(s).
7. Longitudinal evidence
a. We generally need a longitudinal medical record to assess the
duration of your musculoskeletal disorder, because symptoms, signs,
and laboratory findings related to most musculoskeletal disorders
may wax and wane, may improve over time, or may respond to
treatment. By providing evidence over an extended period, the
medical record will show whether your musculoskeletal functioning is
improving, worsening, or unchanging.
b. For 101.19 Pathologic fractures due to any cause and 101.21
Soft tissue injury or abnormality under continuing surgical
management, the required 12-month duration period is stated in the
listing itself. For 101.20A (amputation of both upper extremities)
or 101.20B (hemipelvectomy or hip disarticulation), we presume
satisfaction of the duration requirement.
c. For all listings not referenced in 101.00C7b above, all of
the required criteria must be present simultaneously, or within a
close proximity of time, to satisfy the level of severity needed to
meet the listing. When we use the term ``close proximity of time,''
we mean that all of the relevant criteria have to appear in the
medical record within a period not to exceed 4 months of one
another. When the criterion in question is imaging, we mean those
findings on imaging that we could reasonably expect to have been
present at the date of impairment or date of onset. To meet a
listing that uses the word ``and'' or ``AND'' to link the elements
of the required criteria, the medical record must establish the
simultaneous presence, or presence within a close proximity of time,
of all the required medical criteria. Once this level of severity is
established, the medical record must also show that this level of
severity has continued, or is expected to continue, for a continuous
period of at least 12 months.
8. Surgical treatment
For some musculoskeletal disorders, a medical source may
recommend surgery. If you have not yet had the recommended surgery,
we will not deny your claim based on an assumption that surgery will
resolve or improve your disorder. We will assess each case on an
individual basis. Depending on your response to treatment, or
depending on your medical sources' treatment plans, we may defer our
findings regarding the effect of surgical intervention until a
sufficient period has passed to permit proper consideration or
judgment about your future functioning. See 101.00C5b Response to
treatment.
D. How do we consider symptoms, including pain, under these
listings?
1. Individuals with musculoskeletal disorders may experience
pain or other symptoms; however, statements alone about your pain or
other symptoms cannot establish that you are disabled. Further, an
alleged or reported increase in the intensity of a symptom, such as
pain, no matter how severe, cannot be substituted for a medical sign
or diagnostic finding present in the listing criteria. Pain is
included as just one consideration in paragraph A in listings
101.15, 101.16, and 101.18, but is not required to satisfy the
criteria in these listings. Examples of other findings that will
satisfy the criteria in paragraph A include muscle fatigue,
nonradicular distribution of sensory loss in one or both
extremities, and joint stiffness.
2. To consider your pain, we require objective medical evidence
from an acceptable medical source showing the existence of a
medically determinable impairment(s) (MDI) that could reasonably be
expected to produce the pain. When your musculoskeletal MDI could
reasonably be expected to produce the pain or other symptoms
alleged, we consider all your symptoms, including pain, and the
extent to which your symptoms can reasonably be accepted as
consistent with all of the objective medical evidence, including
medical signs and laboratory or diagnostic findings. See Sec.
416.929 of this chapter for information on how we evaluate pain or
other symptoms related to a musculoskeletal impairment.
E. How do we use the functional criteria under these listings?
1. General. We will determine that your musculoskeletal disorder
meets a listing if it satisfies the medical criteria; includes at
least one of the functional criteria, if included in the listing;
and satisfies the 12-month duration requirement. We will use the
relevant evidence that we have to compare your musculoskeletal
functioning to the functioning of children your age who do not have
impairments. For example, if you are able to walk at home without an
assistive device, we will not consider that to be conclusive
evidence that you have similar functioning to other children your
age who do not have impairments.
2. Medical and functional criteria, birth to attainment of age
3. The medical and functional criteria for children in this age
group are in 101.24 Musculoskeletal disorders of infants and
toddlers, from birth to attainment of age 3, with developmental
motor delay.
3. Functional criteria, age 3 to attainment of age 18. The
functional criteria are based on impairment-related physical
limitations in your ability to use both upper extremities, one or
both lower extremities, or a combination of one upper and one lower
extremity. A musculoskeletal disorder satisfies the functional
criteria of a listing when the medical documentation shows the
presence of at least one of the impairment-related limitations cited
in the listing. The functional criteria require impairment-related
physical limitation of musculoskeletal functioning that has lasted,
or can be expected to last, for a continuous period of at least 12
months, medically documented by one of the following:
a. A documented medical need (see 101.00C6a) for a walker,
bilateral canes, or bilateral crutches (see 101.00C6d);
b. An inability to use one upper extremity to independently
initiate, sustain, and complete age-appropriate activities involving
fine and gross movements (see 101.00E4), and a documented medical
need (see 101.00C6a) for a one-handed assistive device (see
101.00C6d) that requires the use of your other upper extremity;

[[Page 20668]]

c. An inability to use both upper extremities to the extent that
neither can be used to independently initiate, sustain, and complete
age-appropriate activities involving fine and gross movements (see
101.00E4).
4. Fine and gross movements. Fine movements, for the purposes of
these listings, involve use of your wrists, hands, and fingers; such
movements include picking, pinching, manipulating, and fingering.
Gross movements involve use of your shoulders, upper arms, forearms,
and hands; such movements include handling, gripping, grasping,
holding, turning, and reaching. Gross movements also include
exertional abilities such as lifting, carrying, pushing, and
pulling.
5. When we do not use the functional criteria. We do not use the
functional criteria to evaluate amputation of both upper extremities
under 101.20A, hemipelvectomy or hip disarticulation under 101.20B,
and soft tissue injuries or abnormalities under continuing surgical
management under 101.21.
F. What do we consider when we evaluate disorders of the
skeletal spine resulting in compromise of a nerve root(s) (101.15)?
1. General. We consider musculoskeletal disorders such as
skeletal dysplasias, caudal regression syndrome, tethered spinal
cord syndrome, vertebral slippage (spondylolisthesis), scoliosis,
and vertebral fracture or dislocation. Spinal disorders may cause
cervical or lumbar spine dysfunction when abnormalities of the
skeletal spine compromise nerve roots of the cervical spine, a nerve
root of the lumbar spine, or a nerve root of both cervical and
lumbar spines.
2. Compromise of a nerve root(s). Compromise of a nerve root(s),
sometimes referred to as ``nerve root impingement,'' is a term used
when a physical object is seen pushing on the nerve root in an
imaging study or during surgery. Objects such as tumors, herniated
discs, foreign bodies, or arthritic spurs may cause compromise of a
nerve root. It can occur when a musculoskeletal disorder produces
irritation, inflammation, or compression of the nerve root(s) as it
exits the skeletal spine between the vertebrae. Related symptoms
must be associated with, or follow the path of, the specific nerve
root(s), thereby presenting a neuro-anatomic (usually referred to as
``radicular'') distribution of symptoms and signs, including pain,
paresthesia (for example, burning, prickling, or tingling), sensory
loss, and usually muscle weakness specific to the affected nerve
root(s).
a. Compromise of unilateral nerve root of the cervical spine.
Compromise of a nerve root as it exits the cervical spine between
the vertebrae may affect the functioning of the associated upper
extremity. The clinical examination reproduces the related symptoms
based on radicular signs and clinical tests (for example, a positive
Spurling's Test) appropriate to the specific cervical nerve root.
b. Compromise of bilateral nerve roots of the cervical spine.
Although uncommon, if compromise of a nerve root occurs on both
sides of the cervical spinal column, functioning of both upper
extremities may be limited.
c. Compromise of a nerve root(s) of the lumbar spine. Compromise
of a nerve root as it exits the lumbar spine between the vertebrae
may limit the functioning of the associated lower extremity. The
clinical examination reproduces the related symptoms based on
radicular signs and clinical tests. When a nerve root of the lumbar
spine is compromised, we require a positive straight-leg raising
test (also known as a Lasegue test) in both supine and sitting
positions appropriate to the specific lumbar nerve root that is
compromised. (See 101.00C2 for guidance on interpreting information
from a physical examination report.)
G. What do we consider when we evaluate lumbar spinal stenosis
resulting in compromise of the cauda equina (101.16)?
1. We consider the limiting effects of pain, sensory changes,
and muscle weakness caused by compromise of the cauda equina due to
lumbar spinal stenosis. The cauda equina is a bundle of nerve roots
that descends from the lower part of the spinal cord. Lumbar spinal
stenosis can compress the nerves of the cauda equina, causing
sensory changes and muscle weakness that may affect your ability to
stand or walk. Pain related to compromise of the cauda equina is
``nonradicular,'' because it is not typically associated with a
specific nerve root (as is radicular pain in the cervical or lumbar
spine).
2. Compromise of the cauda equina due to spinal stenosis can
affect your ability to walk because of neurogenic claudication (also
known as pseudoclaudication), a disorder usually causing non-
radicular pain that starts in the low back and radiates bilaterally
(or less commonly, unilaterally) into the buttocks and lower
extremities (or extremity). Extension of the lumbar spine, as when
walking or merely standing, provokes the pain of neurogenic
claudication. It is relieved by forward flexion of the lumbar spine
or by sitting.
H. What do we consider when we evaluate reconstructive surgery
or surgical arthrodesis of a major weight-bearing joint (101.17)?
1. We consider reconstructive surgery or surgical arthrodesis
when an acceptable medical source(s) documents the surgical
procedure(s) and associated medical treatments to restore function
of the affected body part(s). The reconstructive surgery may be a
single event or it may be a series of procedures directed toward the
salvage or restoration of functional use of the affected joint.
2. Major weight-bearing joints. The major weight-bearing joints
are the hip, knee, and ankle-foot. The ankle and foot are considered
together as one major joint.
3. Surgical arthrodesis. Surgical arthrodesis is the artificial
fusion of the bones that form a joint, essentially eliminating the
joint.
I. What do we consider when we evaluate abnormality of a major
joint(s) in any extremity (101.18)?
1. General. We consider musculoskeletal disorders that produce
anatomical abnormalities of major joints of the extremities,
resulting in functional abnormalities in the upper or lower
extremities (for example, infections of bones and joints). Major
joint of an upper extremity refers to the shoulder, elbow, and
wrist-hand. We consider the wrist and hand together as one major
joint. Major joint of a lower extremity refers to the hip, knee, and
ankle-foot. We consider the ankle and hindfoot together as one major
joint, because it is necessary for walking. Abnormalities affecting
the joints may include ligamentous laxity or rupture, soft tissue
contracture, or tendon rupture, and can cause muscle weakness of the
affected body part.
2. How do we define abnormality in the extremities? An
anatomical abnormality in any extremity(ies) is one that is readily
observable by a medical source during a physical examination (for
example, subluxation or contracture), or is present on imaging (for
example, ankylosis, bony destruction, joint space narrowing, or
deformity). A functional abnormality is abnormal motion or
instability of the affected part(s), including limitation of motion,
excessive motion (hypermobility), movement outside the normal plane
of motion for the joint (for example, lateral deviation), or
fixation of the affected parts.
J. What do we consider when we evaluate pathologic fractures due
to any cause (101.19)? We consider pathologic fractures of the bones
in the skeletal spine, extremities, or other parts of the skeletal
system. Pathologic fractures result from disorders that weaken the
bones, making them vulnerable to breakage. For non-healing or
complex traumatic fractures without accompanying pathology, see
101.22 Non-healing or complex fracture of the femur, tibia, pelvis,
or one or more of the tarsal bones, or 101.23 Non-healing fracture
of an upper extremity. Pathologic fractures may occur with
osteoporosis, osteogenesis imperfecta or any other skeletal
dysplasias, side effects of medications, and disorders of the
endocrine or other body systems. They must occur on separate,
distinct occasions, rather than multiple fractures occurring at the
same time, but they may affect the same bone(s) multiple times.
There is no required period between the incidents of fracture(s),
but they must all occur within a 12-month period; for example,
separate incidents may occur within hours or days of each other.
However, the associated limitation(s) of function must last, or be
expected to last, at least 12 months.
K. What do we consider when we evaluate amputation due to any
cause (101.20)?
1. General. We consider amputations (the full or partial loss or
absence of any extremity) due to any cause, including trauma,
congenital abnormality or absence, or surgery for treatment of
conditions such as cancer or infection.
2. Amputation of both upper extremities (101.20A). Upper
extremity amputations, for the purposes of this listing, may occur
at any level above the wrists (carpal joints), up to and including
disarticulation of the shoulder (glenohumeral) joint. We do not
evaluate amputations below the wrists under this listing, because
the resulting limitation of function of the thumb(s), finger(s), or
hand(s) will vary, depending on the extent of loss and corresponding
effect on fine and gross

[[Page 20669]]

movements (see 101.00E4). For amputations below the wrist, we will
follow our rules for determining functional equivalence to the
listings (see Sec. 416.926a of this chapter).
3. Hemipelvectomy or hip disarticulation (101.20B).
Hemipelvectomy involves amputation of an entire lower extremity
through the sacroiliac joint. Hip disarticulation involves
amputation of an entire lower extremity through the hip joint
capsule and closure of the remaining musculature over the exposed
acetabular bone.
4. Amputation of one upper extremity at any level above the
wrist and one lower extremity at or above the ankle (101.20C). We
evaluate the absence of one upper extremity and one lower extremity
with regard to whether you have a documented medical need (see
101.00C6a) for a one-handed assistive device (see 101.00C6d), such
as a cane or crutch. In this situation, you may wear a prosthesis
(see 101.00C6b) on your lower extremity, but nevertheless have a
documented medical need for a one-handed assistive device. If you
do, you would need to use your other upper extremity to hold the
assistive device, making the extremity unavailable to perform other
fine and gross movements (see 101.00E4) such as carrying. In such a
case, your disorder would meet this listing.
5. Amputation of one or both lower extremities at or above the
ankle (tarsal joint), (101.20D). When we evaluate amputations of one
or both lower extremities:
a. We consider the condition of your residual limb(s), and
whether you can wear a prosthesis(es) (see 101.00C6b). When you have
a prosthesis(es), we will examine your residual limb with the
prosthesis(es) in place. If you are unable to use a prosthesis(es)
because of residual limb complications that have lasted, or are
expected to last, for at least 12 months, and you are not currently
undergoing surgical management (see 101.00L1) of your condition, we
evaluate your disorder under this listing.
b. Under 101.20D ``Amputation of one or both lower extremities
at or above the ankle (tarsal joint),'' we consider whether you have
a documented medical need (see 101.00C6a) for a hand-held assistive
device(s) (see 101.00C6d) and your ability to walk with the
device(s).
c. If you have a non-healing residual limb(s) and are receiving
ongoing surgical treatment expected to re-establish or improve
function, and that ongoing surgical treatment has not ended, or is
not expected to end, within at least 12 months of the initiation of
the surgical management (see 101.00L1), we evaluate your disorder
under 101.21 Soft tissue injury or abnormality under continuing
surgical management.
L. What do we consider when we evaluate soft tissue injury or
abnormality under continuing surgical management (101.21)?
1. General.
a. We consider any soft tissue injury or abnormality involving
the soft tissues of the body, whether congenital or acquired, when
an acceptable medical source(s) documents the need for ongoing
surgical procedures and associated medical treatments to restore
function of the affected body parts. Surgical management includes
the surgery(-ies) itself, as well as various post-surgical
procedures, surgical complications, infections or other medical
complications, related illnesses, or related treatments that delay a
person's attainment of maximum benefit from therapy.
b. Surgical procedures and associated treatments typically take
place over extended periods, which may render you unable to perform
age-appropriate activity on a sustained basis. To document such
inability, we must have evidence from an acceptable medical
source(s) confirming that the surgical management has continued, or
is expected to continue, for at least 12 months from the date of the
first surgical intervention. These procedures and treatments must be
directed toward saving, reconstructing, or replacing the affected
part of the body to re-establish or improve its function, and not
for cosmetic appearances alone.
c. Examples include malformations, third- and fourth-degree
burns, crush injuries, craniofacial injuries, avulsive injuries, and
amputations with complications of the residual limb(s).
d. We evaluate skeletal spine abnormalities or injuries under
101.15 Disorders of the skeletal spine resulting in compromise of a
nerve root(s) or 101.16 Lumbar spinal stenosis resulting in
compromise of the cauda equina, as appropriate. We evaluate
abnormalities or injuries of bones in the lower extremities under
101.17 Reconstructive surgery or surgical arthrodesis of a major
weight-bearing joint, 101.18 Abnormality of a major joint(s) in any
extremity, or 101.22 Non-healing fracture of the femur, tibia,
pelvis, or one or more of the tarsal bones. We evaluate
abnormalities or injuries of bones in the upper extremities under
101.18 Abnormality of a major joint(s) in any extremity, or 101.23
Non-healing or complex fracture of an upper extremity.
2. Documentation. In addition to the objective medical evidence
we need to establish your soft tissue injury or abnormality, we also
need all of the following medically documented evidence about your
continuing surgical management:
a. Operative reports and related laboratory findings;
b. Records of post-surgical procedures;
c. Records of any surgical or medical complications (for
example, related infections or systemic illnesses);
d. Records of any prolonged post-operative recovery periods and
related treatments (for example, surgeries and treatments for
burns); and
e. An acceptable medical source's plans for additional
surgeries;
f. Records detailing any other factors that have delayed, or
that an acceptable medical source expects to delay, the saving,
restoring, or replacing of the involved part for a continuous period
of at least 12 months following the initiation of the surgical
management.
3. Burns. Third- and fourth-degree burns damage or destroy nerve
tissue, reducing or preventing transmission of signals through those
nerves. Such burns frequently require multiple surgical procedures
and related therapies to re-establish or improve function, which we
evaluate under 101.21 Soft tissue injury or abnormality under
continuing surgical management. When burns are no longer under
continuing surgical management, we evaluate the residual
impairment(s) (see 101.00P). When the residual impairment(s) affects
the musculoskeletal system, as often occurs in third and fourth
degree burns, it can result in permanent musculoskeletal tissue
loss, joint contractures, or loss of extremities. We will evaluate
such impairments under the relevant musculoskeletal listing(s), for
example, 101.18 Abnormality of a major joint(s) in any extremity or
101.20 Amputation due to any cause. When the residual impairment(s)
involves another body system(s), we will evaluate the impairment(s)
under the relevant body system listing (for example, 108.08 Burns).
4. Congenital abnormalities or craniofacial injuries. Surgeons
may treat craniofacial injuries or abnormalities with multiple
surgical procedures. These injuries or abnormalities may affect
vision, hearing, speech, and the initiation of the digestive
process, including mastication. When the craniofacial injury-related
or congenital residual impairment(s) involves another body
system(s), we will evaluate the impairment(s) under the relevant
body system listings. See 101.00P regarding evaluation of residual
impairment(s).
M. What do we consider when we evaluate non-healing or complex
fractures of the femur, tibia, pelvis, or one or more of the tarsal
bones (101.22)?
1. We evaluate a non-healing (nonunion) or complex fracture of
the femur, tibia, pelvis, or one or more of the tarsal bones with
regard to whether you have a documented medical need (see 101.00C6a)
for a bilateral (two-handed) assistive device (see 101.00C6d), such
as a walker or bilateral crutches.
2. Non-healing fracture. A non-healing fracture is a fracture
that has failed to unite completely. Nonunion is usually established
when a minimum of 9 months has elapsed since the injury and the
fracture site has shown no progressive signs of healing for a
minimum of 3 months.
3. Complex fracture. A fracture is complex when one or more of
the following occur:
a. Comminuted (broken into many pieces) bone fragments,
b. Multiple fractures in a single bone,
c. Bone loss due to severe trauma,
d. Damage to the surrounding soft tissue,
e. Severe cartilage damage to the associated joint, or
f. Dislocation of the associated joint.
4. When a complex fracture involves soft tissue damage, the
treatment may involve continuing surgical management to restore or
improve functioning. In such cases, we may evaluate the fracture(s)
under 101.21 Soft tissue injury or abnormality under continuing
surgical management.
N. What do we consider when we evaluate non-healing or complex
fractures of an upper extremity (101.23)?
1. We evaluate a non-healing (nonunion) or complex fracture of
an upper extremity under continuing surgical management (see
101.00L1a) with regard to whether you have an inability to use both
upper extremities to

[[Page 20670]]

independently initiate, sustain, and complete fine and gross
movements.
2. Non-healing fracture. A non-healing fracture is a fracture
that has failed to unite completely. Nonunion is usually established
when a minimum of 9 months has elapsed since the injury and the
fracture site has shown no progressive signs of healing for a
minimum of 3 months.
3. Complex fracture. A fracture is complex when one or more of
the following occur:
a. Comminuted (broken into many pieces) bone fragments
b. Multiple fractures in a single bone
c. Bone loss due to severe trauma
d. Damage to the surrounding soft tissue
e. Severe cartilage damage to the associated joint
f. Dislocation of the associated joint.
O. What do we consider when we evaluate musculoskeletal
disorders of infants and toddlers from birth to attainment of age 3
with developmental motor delay (101.24)?
1. Under listing 101.24 Musculoskeletal disorders of infants and
toddlers, from birth to attainment of age 3, with developmental
motor delay, we use reports from an acceptable medical source(s) to
establish a diagnosis of delay in your motor development. To
evaluate the severity level of your developmental motor delay, we
accept developmental test reports from an acceptable medical source,
or from early intervention specialists, physical and occupational
therapists, and other sources.
a. If there is a standardized developmental assessment in your
medical record, we will use the results to evaluate your
developmental motor delay under 101.24A. Such an assessment compares
your level of development to the level typically expected for
children of your chronological age. If you were born prematurely, we
use your corrected chronological age (CCA) for comparison. Your CCA
is your chronological age adjusted by a period of gestational
prematurity (CCA = (chronological age)--(number of weeks premature))
(see Sec. 416.924b(b) of this chapter).
b. If there is no standardized developmental assessment in your
medical record, we will use narrative developmental reports from a
medical source(s) to evaluate your developmental motor delay under
101.24B. These reports must provide detailed information sufficient
for us to assess the severity of your motor delay. If we cannot
obtain sufficient detail from narrative reports, we may purchase
standardized developmental assessments.
(i) A narrative developmental report is based on clinical
observations, progress notes, and well-baby check-ups, and must
include your developmental history; examination findings (with
abnormal findings noted on repeated examinations); and an overall
assessment of your development (that is, more than one or two
isolated skills) by the medical source.
(ii) Some narrative developmental reports may include results
from developmental screening tests, which can show that you are not
developing or achieving skills within expected timeframes. Although
medical sources may refer to screening test results as supporting
evidence in the narrative developmental report, screening test
results alone cannot establish a medically determinable impairment
or the severity of developmental motor delay.
2. Examples of disorders we evaluate include arthrogryposis,
clubfoot, osteogenesis imperfecta, caudal regression syndrome,
fracture complications, disorders affecting the hip and pelvis, and
complications associated with your disorder or its treatment. Some
medical records may simply document your condition as
``developmental motor delay.''
P. How do we determine when your soft tissue injury or
abnormality or your upper extremity fracture is no longer under
continuing surgical management or you have received maximum
therapeutic benefit?
1. Your soft tissue injury or abnormality or your upper
extremity fracture is no longer under continuing surgical management
when the last surgical procedure or medical treatment directed
toward the re-establishment or improvement of function of the
involved part has occurred. We will find that you have received
maximum therapeutic benefit from treatment if there are no
significant changes in physical findings or on appropriate imaging
for any 6-month period after the last surgical procedure or medical
treatment. We may also find that you have received maximum
therapeutic benefit if your medical source(s) indicates that further
improvement is not expected after the last surgical procedure or
medical treatment.
2. When you have received maximum therapeutic benefit from
treatment, we will evaluate any impairment-related residual
symptoms, signs, and laboratory findings (including those on
imaging), any complications associated with your surgical procedures
or medical treatments, and any residual limitations in your
functioning. Depending upon all of those factors, we may find that
your musculoskeletal impairment is no longer severe.
3. If your impairment(s) remains severe, we will evaluate your
residual limitations and all other impairment-related factors to
determine whether your musculoskeletal disorder meets or medically
equals another listing or functionally equals the listings. If your
impairment involves burns and remains severe, we will follow the
above sequence by evaluating your impairment as described in
101.00L3.
Q. How do we evaluate the severity and duration of your
established musculoskeletal disorder when there is no record of
ongoing treatment?
1. You may not have received ongoing treatment or may not have
an ongoing relationship with the medical community despite having a
musculoskeletal disorder(s). In either of these situations, you will
not have a longitudinal medical record for us to review when we
evaluate your disorder. We may therefore ask you to attend a
consultative examination to determine the severity and potential
duration of your disorder (see Sec. 416.919a(b) of this chapter).
2. In some instances, we may be able to assess the severity and
duration of your musculoskeletal disorder based on your medical
record and current evidence alone. If the information in your case
record is not sufficient or appropriate to show that you have a
musculoskeletal disorder that meets the criteria of one of the
musculoskeletal disorders listings, we will follow the rules in
101.00R.
R. How do we evaluate disorders that do not meet one of the
musculoskeletal listings?
1. These listings are only examples of musculoskeletal disorders
that we consider severe enough to result in marked and severe
functional limitations. If your musculoskeletal disorder(s) does not
meet the criteria of any of these listings, we will consider whether
you have an impairment(s) that meets the criteria of a listing in
another body system.
2. If you have a severe medically determinable impairment(s)
that does not meet any listing, we will determine whether your
impairment(s) medically equals a listing (see Sec. 416.926 of this
chapter). If it does not medically equal a listing, we will
determine whether it functionally equals the listings (see Sec.
416.926a of this chapter).
3. We use the rules in Sec. 416.994a of this chapter when we
decide whether you continue to be disabled.

101.01 Category of Impairments, Musculoskeletal Disorders

101.15 Disorders of the skeletal spine resulting in compromise
of a nerve root(s) (see 101.00F), documented by A, B, C, and D:
A. Symptom(s) of neuro-anatomic (radicular) distribution of one
or more of the following manifestations consistent with compromise
of the affected nerve root(s):
1. Pain; or
2. Paresthesias; or
3. Muscle fatigue.

AND

C. Findings on imaging consistent with compromise of a nerve
root(s) in the cervical or lumbosacral spine (see 101.00C3).

AND

[[Page 20671]]

3. An inability to use both upper extremities to the extent that
neither can be used to independently initiate, sustain, and complete
age-appropriate activities involving fine and gross movements.
101.16 Lumbar spinal stenosis resulting in compromise of the
cauda equina (see 101.00G), documented by A, B, C, and D:
A. Symptoms of neurological compromise, such as pain, manifested
as:
1. Nonradicular distribution of pain in one or both lower
extremities; or
2. Nonradicular distribution of sensory loss in one or both
extremities; or
3. Neurogenic claudication.

AND

C. Findings on imaging or in an operative report consistent with
compromise of the cauda equina with lumbar spinal stenosis.
AND

D. Impairment-related physical limitation of musculoskeletal
functioning that has lasted, or can be expected to last, for a
continuous period of at least 12 months, and medical documentation
of at least one of the following (see 101.00E):
1. A documented medical need for a walker, bilateral canes, or
bilateral crutches; or
2. An inability to use one upper extremity to independently
initiate, sustain, and complete age-appropriate activities involving
fine and gross movements, and a documented medical need for a one-
handed assistive device that requires the use of the other upper
extremity.
101.17 Reconstructive surgery or surgical arthrodesis of a major
weight-bearing joint (see 101.00H), documented by A and B and C:
A. Documented history of reconstructive surgery or surgical
arthrodesis of a major weight-bearing joint.

AND

B. Impairment-related physical limitation of musculoskeletal
functioning that has lasted, or can be expected to last, for a
continuous period of at least 12 months.

AND

C. A documented medical need for a walker, bilateral canes, or
bilateral crutches (see 101.00E).
101.18 Abnormality of a major joint(s) in any extremity (see
101.00I), documented by A, B, C, and D:
A. Chronic joint pain or stiffness.

AND

B. Abnormal motion, instability, or immobility of the affected
joint(s).

AND

D. Impairment-related physical limitation of musculoskeletal
functioning that has lasted, or can be expected to last, for a
continuous period of at least 12 months, and medical documentation
of at least one of the following (see 101.00E):
1. A documented medical need for a walker, bilateral canes, or
bilateral crutches; or
2. An inability to use one upper extremity to independently
initiate, sustain, and complete age-appropriate activities involving
fine and gross movements, and a documented medical need for a one-
handed assistive device that requires the use of the other upper
extremity; or
3. An inability to use both upper extremities to the extent that
neither can be used to independently initiate, sustain, and complete
age-appropriate activities involving fine and gross movements.
101.19 Pathologic fractures due to any cause (see 101.00J),
documented by A and B:
A. Three or more medically documented pathologic fractures
occurring on separate occasions within a 12-month period;

AND

B. Impairment-related physical limitation of musculoskeletal
functioning that has lasted, or can be expected to last, for a
continuous period of at least 12 months, and medical documentation
of at least one of the following (see 101.00E):
1. A documented medical need for a walker, bilateral canes, or
bilateral crutches; or
2. An inability to use one upper extremity to independently
initiate, sustain, and complete age-appropriate activities involving
fine and gross movements, and a documented medical need for a one-
handed assistive device that requires the use of the other upper
extremity; or
3. An inability to use both upper extremities to the extent that
neither can be used to independently initiate, sustain, and complete
age-appropriate activities involving fine and gross movements.
101.20 Amputation due to any cause (see 101.00K), documented by
A, B, C, or D:
A. Amputation of both upper extremities, occurring at any level
above the wrists (carpal joints), up to and including the shoulder
(glenohumeral) joint.

B. Hemipelvectomy or hip disarticulation.

C. Amputation of one upper extremity, occurring at any level
above the wrist (carpal joints), and one lower extremity at or above
the ankle (tarsal joint), and medical documentation of one the
following (see 101.00E):
1. The documented medical need for a one-handed assistive device
requiring the use of the other upper extremity, or
2. The inability to use the remaining upper extremity to
independently initiate, sustain, and complete age-appropriate
activities involving fine and gross movements.

D. Amputation of one or both lower extremities at or above the
ankle (tarsal joint), with complications of the residual limb that
have lasted or can be expected to last for at least 12 months, and
medical documentation of both 1 and 2 (see 101.00E):
1. The inability to use a prosthetic device(s); and
2. The documented medical need for a walker, bilateral canes, or
bilateral crutches.
101.21 Soft tissue injury or abnormality under continuing
surgical management (see 101.00L), documented by A, B, and C in the
medical record:
A. Evidence confirms ongoing surgical management directed
towards saving, reconstructing, or replacing the affected part of
the body.

AND

B. The surgical management has been, or is expected to be,
ongoing for at least 12 months.

AND

C. Maximum benefit from therapy has not yet been achieved.
101.22 Non-healing or complex fracture of the femur, tibia,
pelvis, or one or more of the tarsal bones (see 101.00M), documented
by A and B and C:
A. Solid union not evident on appropriate medically acceptable
imaging and not clinically solid;

AND

B. Impairment-related physical limitation of musculoskeletal
functioning that has lasted, or can be expected to last, for a
continuous period of at least 12 months,

AND

C. A documented medical need for a walker, bilateral canes, or
bilateral crutches (see 101.00E).
101.23 Non-healing or complex fracture of an upper extremity
(see 101.00N), Documented by A and B and C:
A. Nonunion of a fracture, or complex fracture, of the shaft of
the humerus, radius, or ulna, under continuing surgical management,
as defined in 1.00P, directed toward restoration of functional use
of the extremity;

AND

B. Impairment-related physical limitation of musculoskeletal
functioning that has lasted, or can be expected to last, for a
continuous period of at least 12 months,

AND

C. Medical documentation of at least one of the following (see
101.00E):
1. An inability to use one upper extremity to independently
initiate, sustain, and complete age-appropriate activities involving
fine and gross movements, and a documented medical need for a one-
handed assistive device that requires the use of the other upper
extremity; or
2. An inability to use both upper extremities to the extent that
neither can be used to independently initiate, sustain, and

[[Page 20672]]

complete age-appropriate activities involving fine and gross
movements.
101.24 Musculoskeletal disorders of infants and toddlers, from
birth to attainment of age 3, with developmental motor delay (see
101.00O), as documented by A or B:
A. A standardized developmental motor assessment that:
1. Shows motor development not more than one-half the level
typically expected for child's age; or
2. Results in a valid score that is at least three standard
deviations below the mean.

B. Two narrative developmental reports that:
1. Are dated at least 120 days apart; and
2. Show motor development not more than one-half of the level
typically expected for child's age.
* * * * *

104.00 CARDIOVASCULAR SYSTEM

* * * * *
F. Evaluating Other Cardiovascular Impairments
* * * * *
9. What is lymphedema and how will we evaluate it?
* * * * *
b. * * * We will evaluate lymphedema by considering whether the
underlying cause meets or medically equals any listing or whether
the lymphedema medically equals a cardiovascular listing, such as
4.11 Chronic venous insufficiency, or a musculoskeletal listing,
such as 101.18 Abnormality of a major joint(s) in any extremity. * *
*
* * * * *

114.00 IMMUNE SYSTEM DISORDERS

* * * * *
C. Definitions
* * * * *
2. Assistive device(s) has the same meaning as in 101.00C6a.
* * * * *
5. Documented medical need has the same meaning as in 101.00C6a.
* * * * *
8. Fine and gross movements have the same meaning as in
101.00E4.
9. Hand-held assistive device has the same meaning as in
101.00C6d.
10. Major joint of an upper or lower extremity has the same
meaning as in 101.00I1.
* * * * *
D. How do we document and evaluate the listed autoimmune
disorders?
* * * * *
4. Polymyositis and dermatomyositis (114.05).
* * * * *
c. Additional information about how we evaluate polymyositis and
dermatomyositis under the listings.
* * * * *
(ii) If you are of preschool age through adolescence (age 3 to
attainment of age 18), weakness of your pelvic girdle muscles that
results in your inability to rise independently from a squatting or
sitting position or to climb stairs may be an indication that you
are unable to walk without physical or mechanical assistance. * * *
* * * * *
6. Inflammatory arthritis (114.09).
a. General. * * * Clinically, inflammation of major joints in an
upper or lower extremity may be the dominant manifestation causing
difficulties with walking or performing fine and gross movements;
there may be joint pain, swelling, and tenderness. The arthritis may
affect other joints, or cause less limitation in walking or
performing fine and gross movements. * * *
* * * * *
e. How we evaluate inflammatory arthritis under the listings.
(i) Listing-level severity in 114.09 Inflammatory arthritis A
and C1 is shown by the presence of an impairment-related,
significant limitation cited in the criteria of these listings. In
114.09A, listing-level severity is satisfied with persistent
inflammation or deformity in one major joint in a lower extremity
resulting in a documented medical need for a walker, bilateral
canes, or bilateral crutches as required in 114.09A1, or one major
joint in each upper extremity resulting in an impairment-related,
significant limitation in the ability to perform fine and gross
movements as required in 114.09A2. In 114.09C1, if you have the
required ankylosis (fixation) of your cervical or dorsolumbar spine,
we will find that you have an impairment-related significant
limitation in your ability to see in front of you, above you, and to
the side. Therefore, a listing-level impairment in the ability to
walk is implicit in 114.09C1, even though you might not require
bilateral upper limb assistance.
(ii) Listing-level severity is shown in 114.09B and 114.09C2 by
inflammatory arthritis that involves various combinations of
complications of one or more major joints in an upper or lower
extremity or other joints, such as inflammation or deformity, extra-
articular features, repeated manifestations, and constitutional
symptoms and signs. * * *
* * * * *

114.01 Category of Impairments, Immune System Disorders

* * * * *
114.04 Systemic sclerosis (scleroderma). As described in
114.00D3. With:
* * * * *
B. One of the following:
1. Toe contractures or fixed deformity of one or both feet,
resulting in one of the following:
a. A documented medical need for a walker, bilateral canes, or
bilateral crutches (see 114.00C9); or
b. An inability to use one upper extremity to independently
initiate, sustain, and complete age-appropriate activities involving
fine and gross movements, and a documented medical need for a one-
handed assistive device (see 114.00C9) that requires the use of the
other upper extremity; or
2. Finger contractures or fixed deformity in both hands,
resulting in an inability to use both upper extremities to the
extent that neither can be used to independently initiate, sustain,
and complete age-appropriate activities involving fine and gross
movements; or
3. Atrophy with irreversible damage in one or both lower
extremities, resulting in one of the following:
a. A documented medical need for a walker, bilateral canes, or
bilateral crutches (see 114.00C9); or
b. An inability to use one upper extremity to independently
initiate, sustain, and complete age-appropriate activities involving
fine and gross movements, and a documented medical need for a one-
handed assistive device (see 114.00C9) that requires the use of the
other upper extremity; or
4. Atrophy with irreversible damage in both upper extremities,
resulting in an inability to use both upper extremities to the
extent that neither can be used to independently initiate, sustain,
and complete age-appropriate activities involving fine and gross
movements.

C. Raynaud's phenomenon, characterized by:
* * * * *
2. Ischemia with ulcerations of toes or fingers, resulting in
one of the following:
a. A documented medical need for a walker, bilateral canes, or
bilateral crutches (see 114.00C9); or
b. An inability to use one upper extremity to independently
initiate, sustain, and complete age-appropriate activities involving
fine and gross movements, and a documented medical need for a one-
handed assistive device (see 114.00C9) that requires the use of the
other upper extremity; or
c. An inability to use both upper extremities to the extent that
neither can be used to independently initiate, sustain, and complete
age-appropriate activities involving fine and gross movements.
* * * * *
114.05 Polymyositis and dermatomyositis. As described in
114.00D4. With:
A. Proximal limb-girdle (pelvic or shoulder) muscle weakness,
resulting in one of the following:
1. A documented medical need for a walker, bilateral canes, or
bilateral crutches (see 114.00C9); or
2. An inability to use one upper extremity to independently
initiate, sustain, and complete age-appropriate activities involving
fine and gross movements, and a documented medical need for a one-
handed assistive device (see 114.00C9) that requires the use of the
other upper extremity; or
3. An inability to use both upper extremities to the extent that
neither can be used to independently initiate, sustain, and complete
age-appropriate activities involving fine and gross movements.
* * * * *
114.09 Inflammatory arthritis. As described in 114.00D6. With:
A. Persistent inflammation or persistent deformity of:
1. One or more major joints in a lower extremity(ies) resulting
in one of the following:

[[Page 20673]]

a. A documented medical need for a walker, bilateral canes, or
bilateral crutches (see 114.00C9); or
b. An inability to use one upper extremity to independently
initiate, sustain, and complete age-appropriate activities involving
fine and gross movements, and a documented medical need for a one-
handed assistive device (see 114.00C9) that requires the use of the
other upper extremity; or
2. One or more major joints in each upper extremity resulting in
an inability to use both upper extremities to the extent that
neither can be used to independently initiate, sustain, and complete
age-appropriate activities involving fine and gross movements.

B. Inflammation or deformity in one or more major joints of an
upper or lower extremity(ies) with: * * *
* * * * *

PART 416--SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND
DISABLED

Subpart I--[Amended]

0
3. The authority citation for subpart I of part 416 continues to read
as follows:

Authority: Secs. 221(m), 702(a)(5), 1611, 1614, 1619, 1631(a),
(c), (d)(1), and (p), and 1633 of the Social Security Act (42 U.S.C.
421(m), 902(a)(5), 1382, 1382c, 1382h, 1383(a), (c), (d)(1), and
(p), and 1383b); secs. 4(c) and 5, 6(c)-(e), 14(a), and 15, Pub. L.
98-460, 98 Stat. 1794, 1801, 1802, and 1808 (42 U.S.C. 421 note, 423
note, and 1382h note).

0
4. Amend Sec. 416.926a by removing paragraph (m)(1) through (m)(2) and
redesignating paragraphs (m)(3) through (m)(5) as (m)(1) through
(m)(3).

[FR Doc. 2018-08889 Filed 5-4-18; 8:45 am]
BILLING CODE 4191-02-P

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