IMMUNE SYSTEM (Prior Child) IMMUNE SYSTEM DISORDERS (Final Child)
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- Primrose Summers
- 6 years ago
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1 The following is a side-by-side chart comparing the pri child immune system listings (left side) with the new child immune system disders listings (right side). We have copied the text of the new listings on the right side. However, on the left side we have cut and pasted the introducty text of the pri listings beside the introducty text of the new listings that it parallels in meaning. The introducty text in the pri listings has many paragraphs that do not have paragraph headings numbers. Therefe, to assist the reader, we identify paragraphs without a designation in the current listings by placing its section letter and the number of its numerical der in that section in parenthesis at the beginning of the introducty text. In some cases, we have also identified sentences from a paragraph by their numerical der when we compare only part of the introducty text from a pri paragraph with the introducty text in a new paragraph IMMUNE SYSTEM (Pri Child) IMMUNE SYSTEM DISORDERS (Final Child) A. Listed disders include impairments involving deficiency of one me components of the immune system (i.e., antibodyproducing B cells; a number of different types of cells associated with cell-mediated immunity including T-lymphocytes, macrophages and monocytes; and components of the complement system). (B. 6, sentence 2) The limitations may be the result of serious loss of function because of disease affecting a single gan body system, lesser degrees of functional loss because of disease affecting two me gans/body systems associated with significant constitutional symptoms and signs of severe fatigue, fever, malaise, weight loss, and joint pain and stiffness. (B. 6, sentence 1) In children the impairment may affect growth, A. What disders do we evaluate under the immune system disders listings? 1. We evaluate immune system disders that cause dysfunction in one me components of your immune system. a. The dysfunction may be due to problems in antibody production, impaired cell-mediated immunity, a combined type of antibody/cellular deficiency, impaired phagocytosis, complement deficiency. b. Immune system disders may result in recurrent and unusual infections, inflammation and dysfunction of the body s own tissues. Immune system disders can cause a deficit in a single gan body system that results in extreme (that is, very serious) loss of function. They can also cause lesser degrees of limitations in two me gans body systems, and when associated with symptoms signs, such as severe fatigue, fever, malaise, diffuse musculoskeletal pain, involuntary weight loss, can also result in extreme limitation. In children, immune system 1
2 IMMUNE SYSTEM (Pri Child) IMMUNE SYSTEM DISORDERS (Final Child) development, attainment of age-appropriate skills, and disders their treatment may also affect growth, development, perfmance of age-appropriate activities. and the perfmance of age-appropriate activities. c. We ganize the discussions of immune system disders in three categies: Autoimmune disders; Immune deficiency disders, excluding human immunodeficiency virus (HIV) infection; and HIV infection. B. Dysregulation of the immune system may result in the development of a connective tissue disder. Connective tissue disders include several chronic multisystem disders that differ in their clinical manifestation, course, and outcome. These disders are described in part A, 14.00B; inflammaty arthritis is also described in E. (B. 2) Some of the features of connective tissue disders in children may differ from the features in adults. When the clinical features are the same as that seen in adults, the principles and concepts in part A, 14.00B apply. 2. Autoimmune disders (114.00D). Autoimmune disders are caused by dysfunctional immune responses directed against the body s own tissues, resulting in chronic, multisystem impairments that differ in clinical manifestations, course, and outcome. They are sometimes referred to as rheumatic diseases, connective tissue disders, collagen vascular disders. Some of the features of autoimmune disders in children differ from the features of the same disders in adults. The impact of the disders their treatment on physical, psychological, and developmental growth of pre-pubertal children may be considerable, and often differs from that of post-pubertal adolescents adults. 3. Immune deficiency disders, excluding HIV infection (114.00E). Immune deficiency disders are characterized by recurrent unusual infections that respond poly to treatment, and are often associated with complications affecting other parts of the body. Immune deficiency disders are classified as either primary (congenital) acquired. Children with immune deficiency disders also have an increased risk of malignancies and of having autoimmune disders. 2
3 IMMUNE SYSTEM (Pri Child) IMMUNE SYSTEM DISORDERS (Final Child) D. Human Immunodeficiency Virus (HIV) Infection 4. Human immunodeficiency virus (HIV) infection D.1. HIV infection is caused by a specific retrovirus and may be (114.00F). HIV infection may be characterized by increased characterized by susceptibility to one me opptunistic susceptibility to opptunistic infections, cancers, other diseases, cancers, other conditions, as described in Any conditions, as described in child with HIV infection, including one with a diagnosis of acquired immunodeficiency syndrome (AIDS), may be found disabled under this listing if his her impairment meets any of the criteria in is of equivalent severity to an impairment in (B. 3) The documentation needed to establish the existence of a connective tissue disder is medical histy, physical examination, selected labaty studies, appropriate medically acceptable imaging, and, in some instances, tissue biopsy. B. What infmation do we need to show that you have an immune system disder? Generally, we need your medical histy, a rept(s) of a physical examination, a rept(s) of labaty findings, and in some instances, appropriate medically acceptable imaging tissue biopsy repts to show that you have an immune system disder. Therefe, we will make every reasonable efft to obtain your medical histy, medical findings, and results of labaty tests. We explain the infmation we need in me detail in the sections below. (B. 5) A longitudinal clinical recd of at least 3 months demonstrating active disease despite prescribed treatment during this period with the expectation that the disease will remain active f 12 months is necessary f assessment of severity and duration of impairment. D.2. Definitions. In , the terms "resistant to treatment," "recurrent," and "disseminated" have the same general meaning as used by the medical community. The precise meaning of any of these terms will depend upon the specific disease condition in question, the body system affected, the usual course of the disder and its treatment, and the other circumstances of the case. C. Definitions 3
4 IMMUNE SYSTEM (Pri Child) IMMUNE SYSTEM DISORDERS (Final Child) (B. 3, sentences 2-5) Medically acceptable imaging includes, 1. Appropriate medically acceptable imaging includes, but but is not limited to, x-ray imaging, computerized axial is not limited to, angiography, x-ray imaging, computerized axial tomography (CAT scan) magnetic resonance imaging (MRI), tomography (CAT scan) magnetic resonance imaging (MRI), with without contrast material, myelography, and radionuclear with without contrast material, myelography, and radionuclear bone scans. "Appropriate" means that the technique used is the bone scans. Appropriate means that the technique used is the proper one to suppt the evaluation and diagnosis of the proper one to suppt the evaluation and diagnosis of the impairment. However, the Social Security Administration will not impairment. purchase diagnostic tests procedures that may involve significant risk, such as biopsies angiograms. Generally, the existing medical evidence will contain this infmation. 2. Constitutional symptoms signs, as used in these listings, means severe fatigue, fever, malaise, involuntary weight loss. Severe fatigue means a frequent sense of exhaustion that results in significantly reduced physical activity mental function. Malaise means frequent feelings of illness, bodily discomft, lack of well-being that result in significantly reduced physical activity mental function. (D.2. 4) "Disseminated" means that a condition is spread widely over a considerable area body system(s). The type and extent of the spread will depend on the specific disease. 3. Disseminated means that a condition is spread over a considerable area. The type and extent of the spread will depend on your specific disease. 4. Dysfunction means that one me of the body regulaty mechanisms are impaired, causing either an excess deficiency of immunocompetent cells their products. 5. Extra-articular means other than the joints ; f example, an gan(s) such as the heart, lungs, kidneys, skin. E.3. The terms inability to ambulate effectively and inability to 6. Inability to ambulate effectively has the same meaning 4
5 IMMUNE SYSTEM (Pri Child) IMMUNE SYSTEM DISORDERS (Final Child) perfm fine and gross movements effectively in A have the as in B2b. same meaning as in B2b and B2c and must have lasted, be expected to last, f at least 12 months. 7. Inability to perfm fine and gross movements effectively has the same meaning as in B2c. E.2. In A, the term maj joints refers to the maj peripheral joints, which are the hip, knee, shoulder, elbow, wristhand, and ankle-foot, as opposed to other peripheral joints (e.g., the joints of the hand fefoot) axial joints (i.e., the joints of the spine.) The wrist and hand are considered together as one maj joint, as are the ankle and foot. Since only the ankle joint, which consists of the juncture of the bones of the lower leg (tibia and fibula) with the hindfoot (tarsal bones), but not the fefoot, is crucial to weight bearing, the ankle and foot are considered separately in evaluating weight bearing. 8. Maj peripheral joints has the same meaning as in F. 9. Persistent means that a sign(s) symptom(s) has continued over time. The precise meaning will depend on the specific immune system disder, the usual course of the disder, and the other circumstances of your clinical course. (D.2. 3) "Recurrent" means that a condition that responded adequately to an appropriate course of treatment has returned after a period of remission regression. The extent of response ( remission) and the time periods involved will depend on the facts of the particular case. 10. Recurrent means that a condition that previously responded adequately to an appropriate course of treatment returns after a period of remission regression. The precise meaning, such as the extent of response remission and the time periods involved, will depend on the specific disease condition you have, the body system affected, the usual course of the disder and its treatment, and the other facts of your particular case. 5
6 IMMUNE SYSTEM (Pri Child) IMMUNE SYSTEM DISORDERS (Final Child) (D.2. 2) "Resistant to treatment" means that a condition did not 11. Resistant to treatment means that a condition did not respond adequately to an appropriate course of treatment. respond adequately to an appropriate course of treatment. Whether a response is adequate, a course of treatment Whether a response is adequate a course of treatment is appropriate, will depend on the facts of the particular case. appropriate will depend on the specific disease condition you have, the body system affected, the usual course of the disder and its treatment, and the other facts of your particular case. (B. 6, sentence 3) We use the term "severe" in these listings to describe medical severity; the term does not have the same meaning as it does when we use it in connection with a finding at the second step of the sequential evaluation processes in , , and Severe means medical severity as used by the medical community. The term does not have the same meaning as it does when we use it in connection with a finding at the second step of the sequential evaluation process in D. How do we document and evaluate the listed autoimmune disders? 1. Systemic lupus erythematosus (114.02). a. General. Systemic lupus erythematosus (SLE) is a chronic inflammaty disease that can affect any gan body system. It is frequently, but not always, accompanied by constitutional symptoms signs (severe fatigue, fever, malaise, involuntary weight loss). Maj gan body system involvement can include: Respiraty (pleuritis, pneumonitis), cardiovascular (endocarditis, myocarditis, pericarditis, vasculitis), renal (glomerulonephritis), hematologic (anemia, leukopenia, thrombocytopenia), skin (photosensitivity), neurologic (seizures), mental (anxiety, fluctuating cognition ( lupus fog ), mood disders, ganic brain syndrome, psychosis), immune system disders (inflammaty arthritis). Immunologically, there is an array of circulating serum auto-antibodies and pro- and anticoagulant proteins that may occur in a highly variable pattern. 6
7 IMMUNE SYSTEM (Pri Child) IMMUNE SYSTEM DISORDERS (Final Child) b. Documentation of SLE. Generally, but not always, the medical evidence will show that your SLE satisfies the criteria in the current Criteria f the Classification of Systemic Lupus Erythematosus by the American College of Rheumatology found in the most recent edition of the Primer on the Rheumatic Diseases published by the Arthritis Foundation. 2. Systemic vasculitis (114.03). a. General. (i) Vasculitis is an inflammation of blood vessels. It may occur acutely in association with adverse drug reactions, certain chronic infections, and occasionally, malignancies. Me often, it is chronic and the cause is unknown. Symptoms vary depending on which blood vessels are involved. Systemic vasculitis may also be associated with other autoimmune disders; f example, SLE dermatomyositis. C.3. Kawasaki disease, also known as mucocutaneous lymph node syndrome, is characterized by multisystem manifestations, but significant functional impairment is usually due to disease of the conary arteries, which should be evaluated under (ii) Children can develop the vasculitis of Kawasaki disease, of which the most serious manifestation is fmation of conary artery aneurysms and related complications. We evaluate heart problems related to Kawasaki disease under the criteria in the cardiovascular listings (104.00). Children can also develop the vasculitis of anaphylactoid purpura (Henoch- Schoenlein purpura), which may cause intestinal and renal disders. We evaluate intestinal and renal disders related to vasculitis of anaphylactoid purpura under the criteria in the digestive (105.00) genitourinary (106.00) listings. Other clinical patterns include, but are not limited to, polyarteritis nodosa, Takayasu s arteritis (atic arch arteritis), and Wegener s 7
8 IMMUNE SYSTEM (Pri Child) IMMUNE SYSTEM DISORDERS (Final Child) granulomatosis. b. Documentation of systemic vasculitis. Angiography tissue biopsy confirms a diagnosis of systemic vasculitis when the disease is suspected clinically. When you have had angiography tissue biopsy f systemic vasculitis, we will make every reasonable efft to obtain repts of the results of that procedure. However, we will not purchase angiography tissue biopsy. 3. Systemic sclerosis (scleroderma) (114.04). a. General. Systemic sclerosis (scleroderma) constitutes a spectrum of disease in which thickening of the skin is the clinical hallmark. Raynaud's phenomenon, often medically severe and progressive, is present frequently and may be the peripheral manifestation of a vasospastic abnmality in the heart, lungs, and kidneys. The CREST syndrome (calcinosis, Raynaud's phenomenon, esophageal dysmotility, sclerodactyly, and telangiectasia) is a variant that may slowly progress over years to the generalized process, systemic sclerosis. b. Diffuse cutaneous systemic sclerosis. In diffuse cutaneous systemic sclerosis (also known as diffuse scleroderma), maj gan systemic involvement can include the gastrointestinal tract, lungs, heart, kidneys, and muscle in addition to skin blood vessels. Although arthritis can occur, joint dysfunction results primarily from soft tissue/cutaneous thickening, fibrosis, and contractures. c. Localized scleroderma (linear scleroderma and mphea). 8
9 IMMUNE SYSTEM (Pri Child) IMMUNE SYSTEM DISORDERS (Final Child) (i) Localized scleroderma (linear scleroderma and mphea) is me common in children than systemic scleroderma. To assess the severity of the impairment, we need a description of the extent of involvement of linear scleroderma and the location of the lesions. F example, linear scleroderma involving the arm but not crossing any joints is not as functionally limiting as sclerodactyly (scleroderma localized to the fingers). Linear scleroderma of a lower extremity involving skin thickening and atrophy of underlying muscle bone can result in contractures and leg length discrepancy. In such cases, we may evaluate your impairment under the musculoskeletal listings (101.00). (ii) When there is isolated mphea of the face causing facial disfigurement from unilateral hypoplasia of the mandible, maxilla, zygoma, bit, adjudication may be me appropriate under the criteria in the affected body system, such as special senses and speech (102.00) mental disders (112.00). (iii) Chronic variants of these syndromes include disseminated mphea, Shulman s disease (diffuse fasciitis with eosinophilia), and eosinophilia-myalgia syndrome (often associated with toxins such as toxic oil contaminated tryptophan), all of which can impose medically severe musculoskeletal dysfunction and may also lead to restrictive pulmonary disease. We evaluate these variants of the disease under the criteria in the musculoskeletal listings (101.00) respiraty system listings (103.00). d. Documentation of systemic sclerosis (scleroderma). Documentation involves differentiating the clinical features of systemic sclerosis (scleroderma) from other autoimmune 9
10 IMMUNE SYSTEM (Pri Child) IMMUNE SYSTEM DISORDERS (Final Child) disders. However, there may be an overlap. 4. Polymyositis and dermatomyositis (114.05). a. General. (i) Polymyositis and dermatomyositis are related disders that are characterized by an inflammaty process in striated muscle, occurring alone in association with other autoimmune disders. The most common manifestations are symmetric weakness, and less frequently, pain and tenderness of the proximal limb-girdle (shoulder pelvic) musculature. There may also be involvement of the cervical, cricopharyngeal, esophageal, intercostal, and diaphragmatic muscles. (ii) Polymyositis occurs rarely in children; the me common presentation in children is dermatomyositis with symmetric proximal muscle weakness and characteristic skin findings. The clinical course of dermatomyositis can be me severe when it is accompanied by systemic vasculitis rather than just localized to striated muscle. Late in the disease, some children with dermatomyositis develop calcinosis of the skin and subcutaneous tissues, muscles, and joints. We evaluate the involvement of other gans/body systems under the criteria f the listings in the affected body system. b. Documentation of polymyositis and dermatomyositis. Generally, but not always, polymyositis is associated with elevated serum muscle enzymes (creatine phosphokinase (CPK), aminotransferases, and aldolase), and characteristic abnmalities on electromyography and muscle biopsy. In children, the 10
11 IMMUNE SYSTEM (Pri Child) IMMUNE SYSTEM DISORDERS (Final Child) diagnosis of dermatomyositis is suppted largely by medical histy, findings on physical examination that include the characteristic skin findings, and elevated serum muscle enzymes. Muscle inflammation vasculitis depicted on MRI is additional evidence suppting the diagnosis of childhood dermatomyositis. When you have had electromyography, muscle biopsy, MRI f polymyositis dermatomyositis, we will make every reasonable efft to obtain repts of the results of that procedure. However, we will not purchase electromyography, muscle biopsy, MRI. c. Additional infmation about how we evaluate polymyositis and dermatomyositis under the listings. (i) In newbn and younger infants (birth to attainment of age 1), we consider muscle weakness that affects mot skills, such as head control, reaching, grasping, taking solids, selffeeding, under A. In older infants and toddlers (age 1 to attainment of age 3), we also consider muscle weakness affecting your ability to roll over, sit, crawl, walk under A. (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 sitting position to climb stairs may be an indication that you are unable to ambulate effectively. Weakness of your shoulder girdle muscles may result in your inability to perfm lifting, carrying, and reaching overhead, and also may seriously affect your ability to perfm activities requiring fine movements. We evaluate these limitations under A. 11
12 IMMUNE SYSTEM (Pri Child) IMMUNE SYSTEM DISORDERS (Final Child) 5. Undifferentiated and mixed connective tissue disease (114.06). a. General. This listing includes syndromes with clinical and immunologic features of several autoimmune disders, but which do not satisfy the criteria f any of the specific disders described. F example, you may have clinical features of SLE and systemic vasculitis, and the serologic (blood test) findings of rheumatoid arthritis. The most common pattern of undifferentiated autoimmune disders in children is mixed connective tissue disease (MCTD). b. Documentation of undifferentiated and mixed connective tissue disease. Undifferentiated connective tissue disease is diagnosed when clinical features and serologic (blood test) findings, such as rheumatoid fact antinuclear antibody (consistent with an autoimmune disder) are present but do not satisfy the criteria f a specific disease. Children with MCTD have labaty findings of extremely high antibody titers to extractable nuclear antigen (ENA) ribonucleoprotein (RNP) without high titers of anti-dsdna anti-sm antibodies. There are often clinical findings suggestive of SLE childhood dermatomyositis. Many children later develop features of scleroderma. 6. Inflammaty arthritis (114.09). E. (sentence 1) Inflammaty arthritis (114.09) includes a vast array of disders that differ in cause, course, and outcome. E. (sentence 4) Clinically, inflammation of maj joints may be the dominant problem causing difficulties with ambulation fine a. General. The spectrum of inflammaty arthritis includes a vast array of disders that differ in cause, course, and outcome. Clinically, inflammation of maj peripheral joints may be the dominant manifestation causing difficulties with 12
13 IMMUNE SYSTEM (Pri Child) IMMUNE SYSTEM DISORDERS (Final Child) and gross movements, the arthritis may involve other joints cause less restriction of age-appropriate ambulation other movements but be complicated by extra-articular features that cumulatively result in serious functional deficit. C2. If growth is affected by the disder its treatment by immunosuppressive drugs, , Growth impairment, may apply. Children may have growth impairment as a result of the inflammaty arthritides because of the diseases' potential effects on the immature skeleton, open epiphyses, and young cartilage and bone. In such situations, the growth impairment should be evaluated under ff. ambulation fine and gross movements; there may be joint pain, swelling, and tenderness. The arthritis may affect other joints, cause less limitation in ambulation the perfmance of fine and gross movements. However, in combination with extra-articular features, including constitutional symptoms signs (severe fatigue, fever, malaise, involuntary weight loss), inflammaty arthritis may result in an extreme limitation. You may also have impaired growth as a result of the inflammaty arthritis because of its effects on the immature skeleton, open epiphyses, and young cartilage and bone. We evaluate any associated growth impairment under the criteria in E. (sentence 2) F example, in children inflammaty spondyloarthropathies include juvenile ankylosing spondylitis, reactive arthropathies, psiatic arthropathy, and Behçet's disease, as well as undifferentiated spondylitis. b. Inflammaty arthritis involving the axial spine (spondyloarthropathy). In children, inflammaty arthritis involving the axial spine may be associated with disders such as: (i) Reactive arthropathies; (ii) Juvenile ankylosing spondylitis; (iii) Psiatic arthritis; (iv) SEA syndrome (seronegative enthesopathy arthropathy syndrome); (v) Behçet's disease; and (vi) Inflammaty bowel disease. E. (sentence 3) Inflammaty arthritis of peripheral joints likewise comprises many disders, including juvenile rheumatoid arthritis, Sjögren's syndrome, psiatic arthritis, c. Inflammaty arthritis involving the peripheral joints. In children, inflammaty arthritis involving peripheral joints may be associated with disders such as: 13
14 IMMUNE SYSTEM (Pri Child) IMMUNE SYSTEM DISORDERS (Final Child) crystal deposition disders, and Lyme disease. (i) Juvenile rheumatoid arthritis; (ii) Sjögren s syndrome; (iii) Psiatic arthritis; (iv) Crystal deposition disders (gout and pseudogout); (v) Lyme disease; and (vi) Inflammaty bowel disease. E.1. Because the features of inflammaty connective tissue diseases in children are modified by such facts as the child's limited antigenic exposure and immune reactivity, the acute inflammaty connective tissue diseases must be differentiated from each other in der to evaluate duration facts and responses to specific treatments. Chronic conditions must be differentiated from sht-term reversible disders, and also from other connective tissue diseases. E.4. Inability to ambulate effectively is implicit in B. Even though children who demonstrate the findings of B will not dinarily require bilateral upper limb assistance, the required ankylosis of the cervical dsolumbar spine will result in an extreme loss of the ability to see ahead, above, and to the side. d. Documentation of inflammaty arthritis. Generally, but not always, the diagnosis of inflammaty arthritis is based on the clinical features and serologic findings described in the most recent edition of the Primer on the Rheumatic Diseases published by the Arthritis Foundation. e. How we evaluate inflammaty arthritis under the listings. (i) Listing-level severity in A and C1 is shown by an impairment that results in an extreme (very serious) limitation. In A, the criterion is satisfied with persistent inflammation defmity in one maj peripheral weight-bearing joint resulting in the inability to ambulate effectively (as defined in C6) one maj peripheral joint in each upper extremity resulting in the inability to perfm fine and gross movements effectively (as defined in C7). In C1, if you have the required ankylosis (fixation) of your cervical dsolumbar spine, we will find that you have an extreme limitation in your ability to see in front of you, above you, and to the side. Therefe, inability to ambulate effectively is implicit in C1, even though you might not require bilateral upper limb assistance. 14
15 IMMUNE SYSTEM (Pri Child) IMMUNE SYSTEM DISORDERS (Final Child) (ii) Listing-level severity is shown in B, C2, and D by inflammaty arthritis that involves various combinations of complications of one me maj peripheral joints involves other joints, such as inflammation defmity, extra-articular features, repeated manifestations, and constitutional symptoms and signs. Extra-articular impairments may also meet listings in other body systems. E.5. As in through , extra-articular features of an inflammaty arthritis may satisfy the criteria f a listing in an involved extra-articular body system. Such impairments may be found to meet a criterion of C. Extra-articular impairments of lesser severity should be evaluated under D and E. Commonly occurring extra-articular impairments include keratoconjunctivitis sicca, uveitis, iridocyclitis, pleuritis, pulmonary fibrosis nodules, restrictive lung disease, pericarditis, myocarditis, cardiac arrhythmias, atic valve insufficiency, conary arteritis, Raynaud's phenomena, systemic vasculitis, amyloidosis of the kidney, chronic anemia, thrombocytopenia, hypersplenism with compromised immune competence (Felty's syndrome), peripheral neuropathy, radiculopathy, spinal cd cauda equina compression with sensy and mot loss, and heel enthesopathy with functionally limiting pain. (iii) Extra-articular features of inflammaty arthritis may involve any body system; f example: Musculoskeletal (heel enthesopathy), ophthalmologic (iridocyclitis, keratoconjunctivitis sicca, uveitis), pulmonary (pleuritis, pulmonary fibrosis nodules, restrictive lung disease), cardiovascular (atic valve insufficiency, arrhythmias, conary arteritis, myocarditis, pericarditis, Raynaud's phenomenon, systemic vasculitis), renal (amyloidosis of the kidney), hematologic (chronic anemia, thrombocytopenia), neurologic (peripheral neuropathy, radiculopathy, spinal cd cauda equina compression with sensy and mot loss), mental (cognitive dysfunction, po memy), and immune system (Felty's syndrome (hypersplenism with compromised immune competence)). (iv) If both inflammation and chronic defmities are present, we evaluate your impairment under the criteria of any appropriate listing. E. (sentence 5) When persistent defmity without ongoing inflammation is the dominant feature of the impairment, it should 15
16 IMMUNE SYSTEM (Pri Child) IMMUNE SYSTEM DISORDERS (Final Child) be evaluated under ,, if there has been surgical reconstruction, E.6. The fact that a child is dependent on steroids, any other drug, f the control of inflammaty arthritis is, in and of itself, insufficient to find disability. Advances in the treatment of inflammaty connective tissue disease and in the administration of steroids f its treatment have crected some of the previously disabling consequences of continuous steroid use. Therefe, each case must be evaluated on its own merits, taking into consideration the severity of the underlying impairment and any adverse effects of treatment. 7. Sjögren s syndrome (114.10). a. General. (i) Sjögren s syndrome is an immune-mediated disder of the exocrine glands. Involvement of the lacrimal and salivary glands is the hallmark feature, resulting in symptoms of dry eyes and dry mouth, and possible complications, such as cneal damage, blepharitis (eyelid inflammation), dysphagia (difficulty in swallowing), dental caries, and the inability to speak f extended periods of time. Involvement of the exocrine glands of the upper airways may result in persistent dry cough. (ii) Many other gan systems may be involved, including musculoskeletal (arthritis, myositis), respiraty (interstitial fibrosis), gastrointestinal (dysmotility, dysphagia, involuntary weight loss), genitourinary (interstitial cystitis, renal tubular acidosis), skin (purpura, vasculitis,), neurologic (central nervous system disders, cranial and peripheral neuropathies), mental 16
17 IMMUNE SYSTEM (Pri Child) IMMUNE SYSTEM DISORDERS (Final Child) (cognitive dysfunction, po memy), and neoplastic (lymphoma). Severe fatigue and malaise are frequently repted. Sjögren s syndrome may be associated with other autoimmune disders (f example, rheumatoid arthritis SLE); usually the clinical features of the associated disder predominate. b. Documentation of Sjögren s syndrome. If you have Sjögren s syndrome, the medical evidence will generally, but not always, show that your disease satisfies the criteria in the current Criteria f the Classification of Sjögren s Syndrome by the American College of Rheumatology found in the most recent edition of the Primer on the Rheumatic Diseases published by the Arthritis Foundation. E. How do we document and evaluate immune deficiency disders, excluding HIV infection? 1. General. a. Immune deficiency disders can be classified as: (i) Primary (congenital); f example, X-linked agammaglobulinemia, thymic hypoplasia (DiGege syndrome), severe combined immunodeficiency (SCID), chronic granulomatous disease (CGD), C1 esterase inhibit deficiency. (ii) Acquired; f example, medication-related. b. Primary immune deficiency disders are seen mainly in children. However, recent advances in the treatment of these disders have allowed many affected children to survive well into adulthood. Occasionally, these disders are first diagnosed 17
18 IMMUNE SYSTEM (Pri Child) IMMUNE SYSTEM DISORDERS (Final Child) in adolescence adulthood. 2. Documentation of immune deficiency disders. The medical evidence must include documentation of the specific type of immune deficiency. Documentation may be by labaty evidence by other generally acceptable methods consistent with the prevailing state of medical knowledge and clinical practice. 3. Immune deficiency disders treated by stem cell transplantation. a. Evaluation in the first 12 months. If you undergo stem cell transplantation f your immune deficiency disder, we will consider you disabled until at least 12 months from the date of the transplant. b. Evaluation after the 12-month period has elapsed. After the 12-month period has elapsed, we will consider any residuals of your immune deficiency disder as well as any residual impairment(s) resulting from the treatment, such as complications arising from: (i) Graft-versus-host (GVH) disease. (ii) Immunosuppressant therapy, such as frequent infections. (iii) Significant deteriation of other gan systems. 4. Medication-induced immune suppression. Medication effects can result in varying degrees of immune suppression, but most resolve when the medication is ceased. However, if you are prescribed medication f long-term immune suppression, such as 18
19 IMMUNE SYSTEM (Pri Child) IMMUNE SYSTEM DISORDERS (Final Child) after an gan transplant, we will evaluate: D. Human immunodeficiency virus (HIV) infection. D.3. Documentation of HIV infection in children. The medical evidence must include documentation of HIV infection. Documentation may be by labaty evidence by other generally acceptable methods consistent with the prevailing state of medical knowledge and clinical practice. (D.3.a. iv 2) When labaty testing f HIV infection has been perfmed, every reasonable efft must be made to obtain repts of the results of that testing. D.3.a. Documentation of HIV infection in children by definitive diagnosis. A definitive diagnosis of HIV infection in children is documented by one me of the following labaty tests: D.3.a. i F a child 24 months of age older, a serum specimen that contains HIV antibodies. HIV antibodies are usually detected by a screening test. The most commonly used screening test is the ELISA. Although this test is highly sensitive, it may yield false a. The frequency and severity of infections. b. Residuals from the gan transplant itself, after the 12- month period has elapsed. c. Significant deteriation of other gan systems. F. How do we document and evaluate human immunodeficiency virus (HIV) infection? Any child with HIV infection, including one with a diagnosis of acquired immune deficiency syndrome (AIDS), may be found disabled under if his her impairment meets the criteria in that listing is medically equivalent to the criteria in that listing. 1. Documentation of HIV infection. The medical evidence must include documentation of HIV infection. Documentation may be by labaty evidence by other generally acceptable methods consistent with the prevailing state of medical knowledge and clinical practice. When you have had labaty testing f HIV infection, we will make every reasonable efft to obtain repts of the results of that testing. However, we will not purchase labaty testing to establish whether you have HIV infection. a. Definitive documentation of HIV infection. A definitive diagnosis of HIV infection is documented by one me of the following labaty tests: (i) HIV antibody tests. HIV antibodies are usually first detected by an ELISA screening test perfmed on serum. Because the ELISA can yield false positive results, confirmation is required using a me definitive test, such as a Western blot 19
20 IMMUNE SYSTEM (Pri Child) IMMUNE SYSTEM DISORDERS (Final Child) positive results. Therefe, positive results from an ELISA must an immunofluescence assay. Positive results on these tests are be confirmed by a me definitive test (e.g., Western blot, considered to be diagnostic of HIV infection in a child age 18 immunofluescence assay). (See paragraph b, below, f months older. (See b. below f infmation about HIV infmation about HIV antibody testing in children younger than antibody testing in children younger than 18 months of age.) 24 months of age). (ii) Positive viral load (VL) tests. These tests are nmally used to quantitate the amount of the virus present but also document HIV infection. Such tests include the quantitative plasma HIV RNA, quantitative plasma HIV branched DNA, and reverse transcriptase-polymerase chain reaction (RT-PCR). (iii) HIV DNA detection by polymerase chain reaction (PCR). D.3.a. ii A specimen that contains HIV antigen (e.g., serum specimen, lymphocyte culture, cerebrospinal fluid (CSF) specimen). (iv) A specimen that contains HIV antigen (f example, serum specimen, lymphocyte culture, cerebrospinal fluid) in a child age 1 month older. (v) A positive viral culture f HIV from peripheral blood mononuclear cells (PBMC). D.3.a. iii An immunoglobulin A (IgA) serological assay specific f HIV. D.3.a. iv Other test(s) that are highly specific f detection of HIV in children (e.g., polymerase chain reaction (PCR)), that are acceptable methods of detection consistent with the prevailing state of medical knowledge. (D.3.b. 2) F children from birth to the attainment of 24 months (vi) An immunoglobulin A (IgA) serological assay that is specific f HIV. (vii) Other tests that are highly specific f detection of HIV and that are consistent with the prevailing state of medical knowledge. b. Definitive documentation of HIV infection in children 20
21 IMMUNE SYSTEM (Pri Child) IMMUNE SYSTEM DISORDERS (Final Child) of age who have tested positive f HIV antibodies (see D3a from birth to the attainment of 18 months. F children from birth above), HIV infection may be documented by one me of the to the attainment of 18 months of age, and who have tested following: positive f HIV antibodies, HIV infection is documented by: (i) One me of the tests listed in F1a(ii)-F1a(vii). D.3.b.i F an infant 12 months of age less, a CD4 (T4) count of 1500/mm [3] less, a CD4 count less than equal to 20 percent of total lymphocytes. D.3.b.ii F an infant from 12 to 24 months of age, a CD4 (T4) count of 750/mm [3] less, a CD4 count less than equal to 20 percent of total lymphocytes. D.3.b.iii An abnmal CD4/CD8 ratio. D.3.b.iv An IgG significantly greater than less than the nmal range f age. D.3.b. Other acceptable documentation of HIV infection in children. (D.3.b. 3) HIV infection in children may also be documented without the definitive labaty evidence described in paragraph a, the other labaty evidence discussed above, provided that such documentation is consistent with the prevailing state of medical knowledge and clinical practice and is consistent with the other evidence. If such labaty evidence is not available, HIV infection may be documented by the medical histy, clinical and labaty findings, and diagnosis(es) indicated in the medical evidence. F example, a diagnosis of HIV infection in children (ii) F newbn and younger infants (birth to attainment of age 1), a CD4 (T4) count of 1500/mm 3 less, a CD4 count less than equal to 20 percent of total lymphocytes. (iii) F older infants and toddlers from 12 to 18 months of age, a CD4 (T4) count of 750/mm 3 less, a CD4 count less than equal to 20 percent of total lymphocytes. (iv) An abnmal CD4/CD8 ratio. (v) A severely diminished immunoglobulin G (IgG) level (< 4 g/l 400 mg/dl), significantly greater than nmal range f age. c. Other acceptable documentation of HIV infection. We may also document HIV infection without the definitive labaty evidence described in F1a, provided that such documentation is consistent with the prevailing state of medical knowledge and clinical practice and is consistent with the other evidence in your case recd. If no definitive labaty evidence is available, we may document HIV infection by the medical histy, clinical and labaty findings, and diagnosis(es) indicated in the medical evidence. F example, we will accept a diagnosis of HIV infection without definitive labaty evidence of the HIV infection if you have an opptunistic disease that is 21
22 IMMUNE SYSTEM (Pri Child) IMMUNE SYSTEM DISORDERS (Final Child) will be accepted without definitive labaty evidence if the predictive of a defect in cell-mediated immunity (f example, child has an opptunistic disease (e.g., Pneumocystis carinii Pneumocystis pneumonia (PCP)), and there is no other known pneumonia (PCP)) predictive of a defect in cell-mediated cause of diminished resistance to that disease (f example, longterm immunity, and there is no other known cause of diminished steroid treatment, lymphoma). In such cases, we will make resistance to that disease (e.g., long-term steroid treatment, every reasonable efft to obtain full details of the histy, lymphoma). In such cases, every reasonable efft must be made medical findings, and results of testing. to obtain full details of the histy, medical findings, and results of testing. (D.3.b. 1) As noted in paragraph a, above, HIV infection is not documented in children under 24 months of age by a serum specimen containing HIV antibodies. This is because women with HIV infection often transfer HIV antibodies to their newbns. The mother's antibodies can persist in the infant f up to 24 months, even if the infant is not HIV-infected. Only 20 to 30 percent of such infants are actually infected. Therefe, the presence of serum HIV antibodies alone does not establish the presence of HIV infection in a child under 24 months of age. However, the presence of HIV antibodies accompanied by evidence of significantly depressed T-helper lymphocytes (CD4), an abnmal CD4/CD8 ratio, abnmal immunoglobulin G (IgG) may be used to document HIV infection in a child under 24 months of age, even though such testing is not a basis f a definitive diagnosis. 2. CD4 tests. Children who have HIV infection other disders of the immune system may have tests showing a reduction of either the absolute count the percentage of their T- helper lymphocytes (CD4 cells). The extent of immune suppression crelates with the level rate of decline of the CD4 count (relative to the age of the young child). By age 6, children 22
23 IMMUNE SYSTEM (Pri Child) IMMUNE SYSTEM DISORDERS (Final Child) have CD4 counts comparable to those levels found in adults. Generally, in these children when the CD4 count is below 200/mm 3 ( below 14 percent of the total lymphocyte count) the susceptibility to opptunistic infection is greatly increased. (D.4.a. 2) Although a reduced CD4 lymphocyte count in a child Although a reduced CD4 count alone does not establish a may show that there is an increased susceptibility to opptunistic definitive diagnosis of HIV infection, a CD4 count below 200 infections and diseases, that alone does not document the does offer supptive evidence when there are clinical findings, presence, severity, functional effects of a manifestation of HIV but not a definitive diagnosis of an opptunistic infection(s). infection in a child. However, a reduced CD4 count alone does not document the severity functional consequences of HIV infection. D.4. Documentation of the manifestations of HIV infection in children. The medical evidence must also include documentation of the manifestations of HIV infection in children. Documentation may be by labaty evidence by other generally acceptable methods consistent with the prevailing state of medical knowledge and clinical practice. D.4.a. Documentation of the manifestations of HIV infection in children by definitive diagnosis. (D.4.a. 1) The definitive method of diagnosing opptunistic diseases conditions that are manifestations of HIV infection in children is by culture, serological test, microscopic examination of biopsied tissue other material (e.g., bronchial washings). Therefe, every reasonable efft must be made to obtain specific labaty evidence of an opptunistic disease other condition whenever this infmation is available. If a histological other test has been perfmed, the evidence should include a copy of the appropriate rept. If the rept is not obtainable, the summary of hospitalization a rept from the treating source should include details of the findings and results 3. Documentation of the manifestations of HIV infection. The medical evidence must also include documentation of the manifestations of HIV infection. Documentation may be by labaty evidence other generally acceptable methods consistent with the prevailing state of medical knowledge and clinical practice. a. Definitive documentation of the manifestations of HIV infection. The definitive method of diagnosing opptunistic diseases conditions that are manifestations of HIV infection is by culture, serologic test, microscopic examination of biopsied tissue other material (f example, bronchial washings). We will make every reasonable efft to obtain specific labaty evidence of an opptunistic disease other condition whenever this infmation is available. If a histologic other test has been perfmed, the evidence should include a copy of the appropriate rept. If we cannot obtain the rept, the summary of hospitalization a rept from the treating source should include details of the findings and results of the diagnostic studies (including appropriate medically acceptable imaging studies) 23
24 IMMUNE SYSTEM (Pri Child) IMMUNE SYSTEM DISORDERS (Final Child) of the diagnostic studies (including radiographic studies) microscopic examination of the appropriate tissues body fluids. microscopic examination of the appropriate tissues body fluids. D.4.b. Other acceptable documentation of the manifestations of HIV infection in children. (D.4.b. 1) Manifestations of HIV infection in children may also be documented without the definitive labaty evidence described in paragraph a, provided that such documentation is consistent with the prevailing state of medical knowledge and clinical practice and is consistent with the other evidence. If no definitive labaty evidence is available, manifestations of HIV infection may be documented by medical histy, clinical and labaty findings, and diagnosis(es) indicated in the medical evidence. In such cases, every reasonable efft must be made to obtain full details of the histy, medical findings, and results of testing. b. Other acceptable documentation of the manifestations of HIV infection. We may also document manifestations of HIV infection without the definitive labaty evidence described in F3a, provided that such documentation is consistent with the prevailing state of medical knowledge and clinical practice and is consistent with the other evidence in your case recd. F example, many conditions are now commonly diagnosed based on some all of the following: Medical histy, clinical manifestations, labaty findings (including appropriate medically acceptable imaging), and treatment responses. In such cases, we will make every reasonable efft to obtain full details of the histy, medical findings, and results of testing. The following are examples of how we may document manifestations of HIV infection with other appropriate evidence. (i) Although a definitive diagnosis of PCP requires identifying the ganism in bronchial washings, induced sputum, lung biopsy, these tests are frequently bypassed if PCP can be diagnosed presumptively. Supptive evidence may include: Fever, dyspnea, hypoxia, CD4 count below 200 in children 6 years of age older, and no evidence of bacterial pneumonia. Also supptive are bilateral lung interstitial infiltrates on x-ray, a typical pattern on CAT scan, a gallium scan positive f pulmonary uptake. Response to anti-pcp therapy usually requires 5-7 days, and such a response can be supptive of the diagnosis. (D.4.b. 2) Documentation of cytomegalovirus (CMV) disease (114.08D) presents special problems because diagnosis requires (ii) Documentation of Cytomegalovirus (CMV) disease (114.08D) may present special problems because definitive 24
25 IMMUNE SYSTEM (Pri Child) IMMUNE SYSTEM DISORDERS (Final Child) identification of viral inclusion bodies a positive culture from diagnosis (except f chietinitis, which may be diagnosed by the affected gan, and the absence of any other infectious agent. an ophthalmologist optometrist on funduscopic examination) A positive serology test identifies infection with the virus, but requires identification of viral inclusion bodies a positive does not confirm a disease process. With the exception of culture from the affected gan and the absence of any other chietinitis (which may be diagnosed by an ophthalmologist), infectious agent likely to be causing the disease. A positive documentation of CMV disease requires confirmation by biopsy serology test does not establish a definitive diagnosis of CMV other generally acceptable methods consistent with the disease, but does offer supptive evidence of a presumptive prevailing state of medical knowledge and clinical practice. diagnosis of CMV disease. Other clinical findings that suppt a presumptive diagnosis of CMV may include: Fever, urinary culture positive f CMV, and CD4 count below 200 in children 6 years of age older. A clear response to anti-cmv therapy also suppts a diagnosis. (iii) A definitive diagnosis of toxoplasmosis of the brain is based on brain biopsy, but this procedure carries significant risk and is not commonly perfmed. This condition is usually diagnosed presumptively based on symptoms signs of fever, headache, focal neurologic deficits, seizures, typical lesions on brain imaging, and a positive serology test. (iv) Candidiasis of the esophagus (also known as Candida esophagitis) may be presumptively diagnosed based on symptoms of retrosternal pain on swallowing (odynophagia) and either opharyngeal thrush (white patches plaques) diagnosed on physical examination by microscopic documentation of Candida fungal elements from a noncultured specimen scraped from the al mucosa. Treatment with al (systemic) antifungal agents usually produces improvement after 5 me days of therapy, and such a response can be supptive of the diagnosis. D.5. HIV infection in children. The clinical manifestation and 4. HIV infection manifestations specific to children. 25
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