DI 34001.005 Listing of Impairments - Part A - Section Overview

 

The following sections in Part A are applicable to individuals age 18 and over and to children under age 18 where criteria are appropriate.

DI 34001.010 Musculoskeletal Disorders

1.00 Musculoskeletal Disorders (Effective Date: 02/18/2025)

A. Which musculoskeletal 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 under these 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). Musculoskeletal disorders may be congenital or acquired, and may include deformities, amputations, or other abnormalities. These disorders may involve the bones or major joints; or the tendons, ligaments, muscles, or other soft tissues.

2. We evaluate soft tissue injuries (including burns) or abnormalities that are under continuing surgical management (see 1.00O1). The injuries or abnormalities may affect any part of the body, including the face and skull.

3. We evaluate curvatures of the skeletal spine that affect musculoskeletal functioning under 1.15. If a curvature of the skeletal spine is under continuing surgical management (see 1.00O1), we will evaluate it under 1.21 using our rules for determining medical equivalence. See 404.1526 and 416.926 of this chapter.

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 listings in 11.00.

2. We evaluate inflammatory arthritis (for example, rheumatoid arthritis) under the listings in 14.00.

3. We evaluate curvatures of the skeletal spine that interfere with your ability to breathe under the listings in 3.00, impair myocardial function under the listings in 4.00, or result in social withdrawal or depression under the listings in 12.00.

4. We evaluate non-healing or pathological fractures due to cancer, whether it is a primary site or metastases, under the listings in 13.00.

5. We evaluate the leg pain associated with peripheral vascular claudication and foot ulceration associated with peripheral artery disease under the listings in 4.00.

6. We evaluate burns that do not require continuing surgical management under the listings in 8.00.

C. What evidence do we need to evaluate your musculoskeletal disorder?

1. General. We need objective medical evidence from an acceptable medical source to establish that you have a medically determinable musculoskeletal disorder. We also need evidence from both medical and nonmedical sources, who can describe how you function, to assess the severity and duration of your musculoskeletal disorder. We will determine the extent and kinds of evidence we need from medical and nonmedical sources based on the individual facts about your disorder. For our basic rules on evidence, see 404.1512, 404.1513, 404.1520b, 416.912, 416.913, 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 require a medical source's detailed description of the orthopedic, neurologic, or other objective clinical findings appropriate to your specific musculoskeletal disorder from his or her direct observations during your physical examination. We will not accept a report of your statements about your symptoms and limitations in place of the medical source's report of objective clinical findings. We will not use findings on imaging or other diagnostic tests (see 1.00C3) as a substitute for findings on physical examination.

a. 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 and accept the medical source's interpretation of the test. For example, we will assume a straight-leg raising test was conducted properly (that is, in sitting and supine positions), even if the medical source does not specify the positions in which the test was performed.

b. If you use an assistive device (see 1.00C6), the report must support the medical need for the device.

c. If your musculoskeletal disorder causes a reduction in muscle strength, the report must document measurement of the strength of the muscle(s) in question. The measurement should be based on a muscle strength grading system that is considered medically acceptable based on your age and impairments. For example, a grading system of 0 to 5, with 0 indicating complete loss of strength and 5 indicating maximum strength or equivalent medically acceptable scale (see Table 1). Reduction in muscle strength is demonstrated by evidence that your muscle strength is less than active range of motion (ROM) against gravity with maximum resistance. If the reduction in muscle strength involves one or both of your hands, the report must also document measurements of grip and pinch strength.

3. 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 must be consistent with the prevailing state of medical knowledge and clinical practice as the proper technique to support the evaluation of the disorder.

b. Findings on imaging must have lasted, or 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, these abnormalities may correlate poorly with your symptoms, including pain, or with your musculoskeletal functioning. Accordingly, we will not use findings on imaging or other diagnostic tests as a substitute for findings on physical examination about your ability to function, nor can we infer severity or functional limitations based solely on such tests.

d. For our rules on purchasing 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, we need a copy of the operative report, including details of the findings at surgery and information about any medical complications that may have occurred. If we do not have the operative report, we need confirmatory evidence of the surgical procedure from a medical source (for example, detailed follow-up reports or notations in the medical records concerning the surgical procedure in your 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 the following: A description, including the frequency of the administration, of your medications; the type and frequency of therapy you receive; and a description of your response to treatment and any complications you experience related to your musculoskeletal disorder. The effects of treatment may be temporary or long-term. We need information over a sufficient period to determine the effects of treatment on your current musculoskeletal functioning and permit reasonable projections about your future functioning. We will determine the amount of time that constitutes a sufficient period in consultation with a medical consultant on a case-by-case basis. In some cases, we will need additional evidence to make an assessment about your response to treatment. Your musculoskeletal disorder may meet or medically equal one of these listings regardless of whether you were prescribed opioid medication, or whether you were prescribed opioid medication and did not follow this prescribed treatment.

6. Assistive devices.

a. General. An assistive device, for the purposes of these listings, is any device that you use to improve your stability, dexterity, or mobility. An assistive device can be worn (see 1.00C6b and 1.00C6c), hand-held (see 1.00C6d), or used in a seated position (see 1.00C6e). When we use the phrase "documented medical need", we mean that there is evidence from a medical source that supports your medical need for an assistive device (see 1.00C2b) for a continuous period of at least 12 months (see 1.00C6a). This evidence must describe any limitation(s) in your upper or lower extremity functioning and the circumstances for which you need to use the assistive device. We do not require that you have a specific prescription for the assistive device.

b. Prosthesis(es). A prosthesis is a wearable device, such as an artificial limb, that takes the place of an absent body part. If you have a prosthesis(es), we need evidence from a medical source documenting your ability to walk, or perform fine and gross movements (see 1.00E4), with the prosthesis(es) in place. When amputation(s) involves one or both lower extremities, it is not necessary for the medical source 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 evidence from a medical source documenting the condition of your residual limb(s) and the medical basis for your inability to use the device(s).

c. Orthosis(es). An orthosis is a wearable device, such as a brace, that prevents or corrects a dysfunction or deformity by aligning or supporting the affected body part. If you have an orthosis(es), we need evidence from a medical source documenting your ability to walk, or perform fine and gross movements (see 1.00E4), 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 walkers, canes, or crutches, which you hold onto with your hand(s) to support or aid you in walking. When you use a one-handed, hand-held assistive device (such as a cane) with one upper extremity to walk and you cannot use your other upper extremity for fine or gross movements (see 1.00E4), 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 describing how you walk with the device.

e. Wheeled and seated mobility devices. Wheeled and seated mobility devices are assistive devices that you use in a seated position, such as manual wheelchairs, motorized wheelchairs, rollators, and power operated vehicles. If you use a wheeled and seated mobility device, we need evidence from a medical source describing the type of wheeled and seated mobility device that you use and how you use the assistive device including any customizations or modifications to the assistive device itself or for your use of the assistive device. For example, if you use a wheelchair that typically requires the use of both hands but has been customized for your use with one hand, then we will evaluate your use of the assistive device using the criteria in 1.00E3b and not 1.00E3a.

(i) Wheeled and seated mobility devices involving the use of both hands. Some wheeled and seated mobility devices involve the use of both hands to use the assistive device (for example, most manual wheelchairs). If you use a wheeled and seated mobility device that involves the use of both hands, then the need for the assistive device limits the use of both upper extremities.

(ii) Wheeled and seated devices involving the use of one hand. Some wheeled and seated mobility devices involve the use of one hand to use the assistive device (for example, most motorized wheelchairs). If you use a wheeled and seated mobility device that involves the use of one upper extremity and you cannot use your other upper extremity for fine or gross movements (see 1.00E4), then the need for the assistive device limits the use of both upper extremities.

7. Longitudinal evidence.

a. The term pandemic period as used in 1.00C7c means the period beginning on April 2, 2021, and ending on May 11, 2025. The term post-pandemic evaluation period as used in 1.00C7c means the period beginning on May 12, 2025, and ending on May 11, 2029.

b. We generally need a longitudinal medical record to assess the severity and duration of your musculoskeletal disorder because the severity of symptoms, signs, and laboratory findings related to most musculoskeletal disorders may improve over time or respond to treatment. Evidence over an extended period will show whether your musculoskeletal functioning is improving, worsening, or unchanging.

c. For 1.15, 1.16, 1.17, 1.18, 1.20C, 1.20D, 1.22, and 1.23, 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. The phrase "within a close proximity of time" means that all of the relevant criteria must appear in the medical record within a consecutive 4-month period, except for claims determined or decided during the pandemic period or post-pandemic evaluation period. For claims determined or decided during the pandemic period or post-pandemic evaluation period, all of the relevant criteria must appear in the medical record within a consecutive 12-month period. When the criterion is imaging, we mean that we could reasonably expect the findings on imaging to have been present at the date of impairment or date of onset. For listings that use the word "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 and physical therapy. For some musculoskeletal disorders, a medical source may recommend surgery or physical therapy (PT). If you have not yet had the recommended surgery or PT, we will not assume that these interventions will resolve your disorder or improve your functioning. We will assess each case on an individual basis. Depending on your response to treatment, or your medical sources' treatment plans, we may defer our findings regarding the effect of surgery or PT, until a sufficient period has passed to permit proper consideration or judgment about your future functioning. When necessary, we will follow the rules on following prescribed treatment in 404.1530 and 416.930 of this chapter, including consideration of your reasons for failure to follow prescribed treatment.

D. How do we consider symptoms, including pain, under these listings?

1. Musculoskeletal disorders may cause pain or other symptoms; however, your statements about your pain or other symptoms will not alone establish that you are disabled. We will not substitute an alleged or a reported increase in the intensity of a symptom, such as pain, no matter how severe, for a medical sign or diagnostic finding present in the listing criteria. Pain is included as just one consideration in 1.15A, 1.16A, and 1.18A, but it is not required to satisfy the criteria in 1.15, 1.16, and 1.18.

2. To consider your symptom(s), we require objective medical evidence from an acceptable medical source showing the existence of a medically determinable musculoskeletal impairment that we could reasonably expect to produce the symptom(s). See 404.1529 and 416.929 of this chapter for how we evaluate symptoms, including pain, related to your musculoskeletal disorder.

E. How do we use the functional criteria to evaluate your musculoskeletal disorder under these listings?

1. General. 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. 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. We do not use the functional criteria in 1.20A, 1.20B, or 1.21.

2. Work environment. We use the relevant evidence that we have to evaluate 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.

3. Functional criteria. 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 limitation of musculoskeletal functioning must be 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) or a wheeled and seated mobility device involving the use of both hands (see 1.00C6e(i));

b. An inability to use one upper extremity to independently initiate, sustain, and complete work-related activities involving fine and gross movements (see 1.00E4), and a documented medical need (see 1.00C6a) for a one-handed, hand-held assistive device (see 1.00C6d) that requires the use of your other upper extremity or a wheeled and seated mobility device involving the use of one hand (see 1.00C6e(ii));

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 1.00E4).

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. Examples of performing fine and gross movements include, but are not limited to, taking care of personal hygiene, sorting and handling papers or files, and placing files in a file cabinet at or above waist level.

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. We consider spinal nerve disorders that originate in the nervous system (for example, spinal arachnoiditis), under the neurological disorders body system, 11.00.

2. Compromise of a nerve root(s). Compromise of a nerve root, sometimes referred to as "nerve root impingement", is a phrase used when a physical object, such as a tumor, herniated disc, foreign body, or arthritic spur, is pushing on the nerve root as seen on imaging or during surgery. 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 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 physical examination reproduces the related symptoms based on radicular signs and clinical tests appropriate to the specific cervical nerve root (for example, a positive Spurling test).

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 physical 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 Lasègue test) in both supine and sitting positions appropriate to the specific lumbar nerve root that is compromised.

G. What do we consider when we evaluate lumbar spinal stenosis resulting in compromise of the cauda equina (1.16)?

1. General. We consider how pain, sensory changes, and muscle weakness caused by compromise of the cauda equina due to lumbar spinal stenosis affect your functioning. 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 lumbar spinal stenosis can affect your ability to walk or stand because of neurogenic claudication (also known as pseudoclaudication), a condition usually causing nonradicular 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, which occurs when you walk or stand, may provoke the pain of neurogenic claudication. The pain may be 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. General. 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, or eliminate motion in, the affected major weight-bearing joint. Reconstructive surgery may be done in a single procedure or a series of procedures directed toward the salvage or restoration of functional use of the affected joint.

2. 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 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, which result in functional abnormalities in the upper or lower extremities (for example, osteoarthritis, chronic infections of bones and joints, and surgical arthrodesis of a joint). Abnormalities of the joints include ligamentous laxity or rupture, soft tissue contracture, or tendon rupture, and can cause muscle weakness of the affected joint(s).

a. An anatomical abnormality 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, joint space narrowing, bony destruction, ankylosis, or deformity).

b. A functional abnormality is abnormal motion or instability of the affected joint(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 joint(s).

2. 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.

3. 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.

J. What do we consider when we evaluate pathologic fractures due to any cause (1.19)? 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. 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. Under 1.19, the fractures must have occurred on separate, distinct occasions, rather than multiple fractures occurring at the same time, but the fractures may affect the same bone(s) multiple times. There is no required time that must elapse between the fractures, but all three must occur within a 12-month period; for example, separate incidents may occur within hours or days of each other. We evaluate non-healing or complex traumatic fractures without accompanying pathology under 1.22 or 1.23.

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). Under 1.20A, we consider upper extremity amputations that occur at any level at or above the wrists (carpal joints), up to and including disarticulation of the shoulder (glenohumeral) joint. If you have had both upper extremities amputated at any level at or above the wrists up to and including the shoulder, your impairment satisfies the duration requirement in 404.1509 and 416.909 of this chapter. For amputations below the wrist, we will follow the rules described in 1.00S. We do not evaluate amputations below the wrist under 1.20A 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.

3. Hemipelvectomy or hip disarticulation (1.20B). Under 1.20B, we consider hemipelvectomy, which involves amputation of an entire lower extremity through the sacroiliac joint, and hip disarticulation, which involves amputation of an entire lower extremity through the hip joint capsule and closure of the remaining musculature over the exposed acetabular bone. If you have had a hemipelvectomy or hip disarticulation, your impairment satisfies the duration requirement in 404.1509 and 416.909 of this chapter.

4. Amputation of one upper extremity and one lower extremity (1.20C). Under 1.20C, we consider the amputation of one upper extremity at any level at or above the wrist and one lower extremity at or above the ankle. If you have a documented medical need for a one-handed, hand-held assistive device (such as a cane) or a wheeled and seated mobility device involving the use of one hand (such as a motorized wheelchair), then you must use your remaining upper extremity to hold the device, making the extremity unavailable to perform other fine and gross movements (see 1.00E4).

5. Amputation of one lower extremity or both lower extremities with complications of the residual limb(s) (1.20D). Under 1.20D, we consider the amputation of one lower extremity or both lower extremities at or above the ankle. We also consider the condition of your residual limb(s), whether you can wear a prosthesis(es) (see 1.00C6b), and whether you have a documented medical need (see 1.00C6a) for a hand-held assistive device(s) (see 1.00C6d) or a wheeled and seated mobility device (see 1.00C6e). 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 1.00L), we evaluate your musculoskeletal disorder under 1.21.

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) (see 1.00O1). 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 your attainment of maximum benefit from therapy (see 1.00O2).

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 or 1.16, as appropriate. We evaluate abnormalities or injuries of bones in the lower extremities under 1.17, 1.18, or 1.22. We evaluate abnormalities or injuries of bones in the upper extremities under 1.18 or 1.23.

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. When burns are no longer under continuing surgical management (see 1.00O1), we evaluate the residual impairment(s). 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 disorders listing, for example, 1.18 or 1.20. When the residual impairment(s) involves another body system, we will evaluate the impairment(s) under the listings in the relevant body system(s).

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 listings in the relevant body system(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 talocrural bones (1.22)?

1. Non-healing fracture. A non-healing (nonunion) 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, or minimal, progressive signs of healing for a minimum of 3 months.

2. Complex fracture. A complex fracture is a fracture with one or more of the following:

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.

3. 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.

N. What do we consider when we evaluate non-healing or complex fracture of an upper extremity (1.23)?

1. Non-healing fracture. A non-healing (nonunion) 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, or minimal, progressive signs of healing for a minimum of 3 months.

2. Complex fracture. A complex fracture is a fracture with one or more of the following:

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.

3. 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.

O. How will we determine whether your soft tissue injury or abnormality or your upper extremity fracture is no longer under continuing surgical management or you have received maximum benefit from therapy?

1. We will determine that your soft tissue injury or abnormality, or your upper extremity fracture, is no longer under continuing surgical management, as used in 1.21 and 1.23, when the last surgical procedure or medical treatment directed toward the re-establishment or improvement of function of the involved part has occurred.

2. We will determine that you have received maximum benefit from therapy, as used in 1.21, 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 determine that you have received maximum benefit from therapy if your medical source(s) indicates that further improvement is not expected after the last surgical procedure or medical treatment.

3. When you have received maximum benefit from therapy, 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 (see 1.00S).

P. How do we evaluate your musculoskeletal disorder if there is no record of ongoing treatment?

1. Despite having a musculoskeletal disorder, you may not have received ongoing treatment, may have just begun treatment, may not have access to prescribed medical treatment, or may not have an ongoing relationship with the medical community. In any of these situations, you will not have a longitudinal medical record for us to review when we evaluate your disorder and we may 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 to show that you have a musculoskeletal disorder that meets the criteria of one of the musculoskeletal disorders listings, we will follow the rules described in 1.00S.

Q. How do we consider the effects of obesity when we evaluate your musculoskeletal disorder? Obesity is a medically determinable impairment that is often associated with musculoskeletal disorders. Obesity increases stress on weight-bearing joints and may contribute to limitation of the range of motion of the skeletal spine and extremities. The combined effects of obesity with a musculoskeletal disorder can be greater than the effects of each of the impairments considered separately. We consider the additional and cumulative effects of your obesity when we determine whether you have a severe musculoskeletal disorder, a listing-level musculoskeletal disorder, a combination of impairments that medically equals the severity of a listed impairment, and when we assess your residual functional capacity.

R. How do we evaluate your musculoskeletal disorder if there is evidence establishing a substance use 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, 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.

S. How do we evaluate musculoskeletal disorders that do not meet one of these listings?

1. These listings are only examples of musculoskeletal disorders that we consider severe enough to prevent you from doing any gainful activity. If your impairment(s) does not meet the criteria of any of these listings, we must also 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 a listing, we will determine whether your impairment(s) medically equals a listing. See 404.1526 and 416.926 of this chapter. If your impairment(s) does not meet or medically equal a listing, you may or may not have the residual functional capacity to engage in substantial gainful activity. We proceed to the fourth step and, if necessary, the fifth step of the sequential evaluation process in 404.1520 and 416.920 of this chapter.

3. We use the rules in 404.1594 and 416.994 of this chapter, as appropriate, when we decide whether you continue to be disabled.

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. Neuro-anatomic (radicular) distribution of one or more of the following symptoms consistent with compromise of the affected nerve root(s):

1. Pain; or

2. Paresthesia; or

3. Muscle fatigue.

AND

B. Radicular distribution of neurological signs present during physical examination (see 1.00C2) or on a diagnostic test (see 1.00C3) and evidenced by 1, 2, and either 3 or 4:

1. Muscle weakness; and

2. Sign(s) of nerve root irritation, tension, or compression, consistent with compromise of the affected nerve root (see 1.00F2); and

3. Sensory changes evidenced by:

a. Decreased sensation; or

b. Sensory nerve deficit (abnormal sensory nerve latency) on electrodiagnostic testing; or

4. Decreased deep tendon reflexes.

AND

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

AND

D. Impairment-related physical limitation of musculoskeletal functioning that has lasted, or is expected to last, for a continuous period of at least 12 months, and medical documentation of at least one of the following:

1. A documented medical need (see 1.00C6a) for a walker, bilateral canes, or bilateral crutches (see 1.00C6d) or a wheeled and seated mobility device involving the use of both hands (see 1.00C6e(i)); or

2. An inability to use one upper extremity to independently initiate, sustain, and complete work-related activities involving fine and gross movements (see 1.00E4), and a documented medical need (see 1.00C6a) for a one-handed, hand-held assistive device (see 1.00C6d) that requires the use of the other upper extremity or a wheeled and seated mobility device involving the use of one hand (see 1.00C6e(ii)); 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 (see 1.00E4).

1.16 Lumbar spinal stenosis resulting in compromise of the cauda equina (see 1.00G), documented by A, B, C, and D:

A. Symptom(s) of neurological compromise manifested as:

1. Nonradicular distribution of pain in one or both lower extremities; or

2. Nonradicular distribution of sensory loss in one or both lower extremities; or

3. Neurogenic claudication.

AND

B. Nonradicular neurological signs present during physical examination (see 1.00C2) or on a diagnostic test (see 1.00C3) and evidenced by 1 and either 2 or 3:

1. Muscle weakness.

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 (see 1.00C3) or in an operative report (see 1.00C4) consistent with compromise of the cauda equina with lumbar spinal stenosis.

AND

D. Impairment-related physical limitation of musculoskeletal functioning that has lasted, or is expected to last, for a continuous period of at least 12 months, and medical documentation of at least one of the following:

1. A documented medical need (see 1.00C6a) for a walker, bilateral canes, or bilateral crutches (see 1.00C6d) or a wheeled and seated mobility device involving the use of both hands (see 1.00C6e(i)); or

2. An inability to use one upper extremity to independently initiate, sustain, and complete work-related activities involving fine and gross movements (see 1.00E4), and a documented medical need (see 1.00C6a) for a one-handed, hand-held assistive device (see 1.00C6d) that requires the use of the other upper extremity or a wheeled and seated mobility device involving the use of one hand (see 1.00C6e(ii)).

1.17 Reconstructive surgery or surgical arthrodesis of a major weight-bearing joint (see 1.00H), documented by A, B, and C:

A. 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 is expected to last, for a continuous period of at least 12 months.

AND

C. A documented medical need (see 1.00C6a) for a walker, bilateral canes, or bilateral crutches (see 1.00C6d) or a wheeled and seated mobility device involving the use of both hands (see 1.00C6e(i)).

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, or 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 is expected to last, for a continuous period of at least 12 months, and medical documentation of at least one of the following:

1. A documented medical need (see 1.00C6a) for a walker, bilateral canes, or bilateral crutches (see 1.00C6d) or a wheeled and seated mobility device involving the use of both hands (see 1.00C6e(i)); or

2. An inability to use one upper extremity to independently initiate, sustain, and complete work-related activities involving fine and gross movements (see 1.00E4), and a documented medical need (see 1.00C6a) for a one-handed, hand-held assistive device (see 1.00C6d) that requires the use of the other upper extremity or a wheeled and seated mobility device involving the use of one hand (see 1.00C6e(ii)); 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 (see 1.00E4).

1.19 Pathologic fractures due to any cause (see 1.00J), documented by A and B:

A. Pathologic fractures occurring on three separate occasions within a 12-month period.

AND

B. Impairment-related physical limitation of musculoskeletal functioning that has lasted, or is expected to last, for a continuous period of at least 12 months, and medical documentation of at least one of the following:

1. A documented medical need (see 1.00C6a) for a walker, bilateral canes, or bilateral crutches (see 1.00C6d) or a wheeled and seated mobility device involving the use of both hands (see 1.00C6e(i)); or

2. An inability to use one upper extremity to independently initiate, sustain, and complete work-related activities involving fine and gross movements (see 1.00E4), and a documented medical need (see 1.00C6a) for a one-handed, hand-held assistive device (see 1.00C6d) that requires the use of the other upper extremity or a wheeled and seated mobility device involving the use of one hand (see 1.00C6e(ii)); 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 (see 1.00E4).

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 at or 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 at or above the wrist (carpal joints), and amputation of one lower extremity, occurring at or above the ankle (talocrural joint), and medical documentation of at least one of the following:

1. A documented medical need (see 1.00C6a) for a walker, bilateral canes, or bilateral crutches (see 1.00C6d) or a wheeled and seated mobility device involving the use of both hands (see 1.00C6e(i)); or

2. A documented medical need (see 1.00C6a) for a one-handed, hand-held assistive device (see 1.00C6d) requiring the use of the other upper extremity or a wheeled and seated mobility device involving the use of one hand (see 1.00C6e(ii)); or

3. The inability to use the remaining upper extremity to independently initiate, sustain, and complete work-related activities involving fine and gross movements (1.00E4).

OR

D. Amputation of one or both lower extremities, occurring at or above the ankle (talocrural joint), with complications of the residual limb(s) that have lasted, or are expected to last, for a continuous period of at least 12 months, and medical documentation of 1 and 2:

1. The inability to use a prosthesis(es); and

2. A documented medical need (see 1.00C6a) for a walker, bilateral canes, or bilateral crutches (see 1.00C6d) or a wheeled and seated mobility device involving the use of both hands (see 1.00C6e(i)).

1.21 Soft tissue injury or abnormality under continuing surgical management (see 1.00L), documented by A, B, and C:

A. Evidence confirms continuing surgical management (see 1.00O1) directed toward saving, reconstructing, or replacing the affected part of the body.

AND

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

AND

C. Maximum benefit from therapy (see 1.00O2) has not yet been achieved.

1.22 Non-healing or complex fracture of the femur, tibia, pelvis, or one or more of the talocrural bones (see 1.00M), documented by A, B, and C:

A. Solid union not evident on imaging (see 1.00C3) and not clinically solid.

AND

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

AND

C. A documented medical need (see 1.00C6a) for a walker, bilateral canes, or bilateral crutches (see 1.00C6d) or a wheeled and seated mobility device involving the use of both hands (see 1.00C6e(i)).

1.23 Non-healing or complex fracture of an upper extremity (see 1.00N), documented by A and B:

A. Nonunion or complex fracture of the shaft of the humerus, radius, or ulna, under continuing surgical management (see 1.00O1) directed toward restoration of functional use of the extremity.

AND

B. Medical documentation of an inability to independently initiate, sustain, and complete work-related activities involving fine and gross movements (see 1.00E4) that has lasted, or is expected to last, for a continuous period of at least 12 months.

 

 

DI 34001.016 Cardiovascular Disorders

4.00 CARDIOVASCULAR DISORDERS (Effective date: 10/30/2026)

A. How do we define cardiovascular disorders and cardiovascular terms?

1. What do we mean by a cardiovascular disorder?

a. We mean any disorder that affects the proper functioning of the heart or the circulatory system (that is, arteries, veins, capillaries, and the lymphatic drainage). The disorder can be congenital or acquired.

b. Cardiovascular disorders result from one or more of four consequences of heart disease:

(i) Chronic heart failure (chronic HF) or ventricular dysfunction.

(ii) Discomfort or pain due to myocardial ischemia, with or without necrosis of the heart muscle.

(iii) Syncope, or near syncope, due to inadequate cerebral perfusion from any cardiac cause, such as obstruction of flow or disturbance in rhythm or conduction resulting in inadequate cardiac output.

(iv) Hypoxemia (reduced oxygen concentration in the blood) due to right-to-left shunt or pulmonary vascular disease.

c. Disorders of the veins or arteries (for example, obstruction, rupture, or aneurysm) may cause impairments of the lower extremities (peripheral vascular disease), the central nervous system, the eyes, the kidneys, and other organs. We will evaluate peripheral vascular disease under 4.11 or 4.12 and impairments of another body system(s) under the listings for that body system(s).

2. What do we consider in evaluating cardiovascular disorders? The listings in this section describe cardiovascular disorders based on the medical and other evidence, including response to a regimen of prescribed treatment and functional limitations.

3. What do the following terms or phrases mean in these listings?

a. Medical consultant is a person defined in §§ 404.1616(a) and 416.1016(a) of this chapter. This term does not include medical sources who provide consultative examinations for us. We use the abbreviation “MC” throughout this section to designate a medical consultant.

b. Persistent means that the longitudinal clinical record shows that, with few exceptions, the required finding(s) has been present, or is expected to be present, for a continuous period of at least 12 months, such that a pattern of continuing severity is established. By “exceptions,” we mean brief periods when the required finding(s) is greatly reduced or gone. These periods are so brief or inconsequential, the required finding(s) remains a factor in the person's condition.

c. Recurrent means that the longitudinal clinical record shows that, within a consecutive 12-month period, the finding(s) occurs at least three times, with intervening periods of improvement of sufficient duration that it is clear that separate events are involved. By “improvement of sufficient duration,” we mean the finding is greatly reduced or not present for long enough that the required finding(s) is no longer a factor in the person's condition.

d. Appropriate medically acceptable imaging means that the technique used is the proper one to evaluate and diagnose the impairment and is commonly recognized as accurate for assessing the cited finding.

e. A consecutive 12-month period means a period of 12 consecutive months, all or part of which must occur within the period we are considering in connection with an application or continuing disability review.

B. What documentation do we need to evaluate cardiovascular disorders?

1. What basic documentation do we need? We need sufficiently detailed reports of history, physical examinations, laboratory studies, and any prescribed treatment and response to allow us to assess the severity and duration of your cardiovascular disorder. A longitudinal clinical record covering a period of not less than 3 months of observations and treatment is usually necessary, unless we can make a determination or decision based on the current evidence we already have.

2. Why is a longitudinal clinical record important? We will usually need a longitudinal clinical record to assess the severity and expected duration of your impairment(s). If you have a listing-level impairment, you probably will have received medically prescribed treatment. Whenever there is evidence of such treatment, your longitudinal clinical record should include a description of the ongoing management and evaluation provided by your medical source(s). It should also include your response to this medical management, as well as information about the nature and severity of your impairment. The record will provide us with information on your functional status over an extended period of time and show whether your ability to function is improving, worsening, or unchanging.

3. What if you have not received ongoing medical treatment?

a. You may not have received ongoing treatment or have an ongoing relationship with the medical community despite the existence of a severe impairment(s). In this situation, we will base our evaluation on the current evidence we have. If you do not receive treatment, you cannot show an impairment that meets the criteria of most of these listings. However, we may find you disabled because you have another impairment(s) that, in combination with your cardiovascular disorder, medically equals a listing, or we may find you disabled at a later step in the evaluation process based on a consideration of your residual functional capacity and age, education, and work experience.

b. Unless we can decide your claim favorably on the basis of the current evidence we already have, a longitudinal record is still important. In instances when there is no or insufficient longitudinal evidence, we may purchase a consultative examination(s) to help us establish the existence, severity, and duration of your impairment

4. When will we wait before we ask for more evidence?

a. We will wait when we have information showing that your impairment is not yet stable and the expected change in your impairment might affect our determination or decision. In these situations, we need to wait to properly evaluate the severity and duration of your impairment during a stable period. Examples of when we might wait are:

(i) If you have had a recent acute event; for example, a myocardial infarction (heart attack);

(ii) If you have recently had a corrective cardiac procedure; for example, coronary artery bypass grafting;

(iii) If you have started new drug therapy and your response to this treatment has not yet been established; for example, beta-blocker therapy for dilated cardiomyopathy.

b. In these situations, we will obtain more evidence 3 months following the event before we evaluate your impairment. However, we will not wait if we have enough information to make a determination or decision based on all of the relevant evidence in your case.

5. Will we purchase any studies? In appropriate situations, we may purchase studies necessary to substantiate the existence of a medically determinable impairment or to document the severity of your impairment, generally after we have evaluated the evidence we already have. We will not purchase studies involving exercise testing if there is significant risk involved or if there is another medical reason not to perform the test. We will follow 4.00C6, 4.00C7, and 4.00C8 when we decide whether to purchase exercise testing.

6. What studies will we not purchase? We will not purchase any studies involving cardiac catheterization, such as coronary angiography, arteriograms, or electrophysiological studies. However, if the results of a catheterization are part of the existing evidence we have, we will consider them together with the other relevant evidence. See 4.00C15a.

C. How do we use cardiovascular test results?

1. What is an ECG?

a. ECG stands for electrocardiograph or electrocardiogram. An electrocardiograph is a machine that records electrical impulses of your heart on a strip of paper called an electrocardiogram or a tracing. To record the ECG, a technician positions a number of small contacts (or leads) on your arms, legs, and across your chest to connect them to the ECG machine. An ECG may be done while you are resting or exercising.

b. The ECG tracing may indicate that you have a heart abnormality. It may indicate that your heart muscle is not getting as much oxygen as it needs (ischemia), that your heart rhythm is abnormal (arrhythmia), or that there are other abnormalities of your heart, such as left ventricular enlargement.

2. How do we evaluate ECG evidence? We consider a number of factors when we evaluate ECG evidence:

a. An original or legible copy of the 12-lead ECG obtained at rest must be appropriately dated and labeled, with the standardization inscribed on the tracing. Alteration in standardization of specific leads (such as to accommodate large QRS amplitudes) must be identified on those leads.

(i) Detailed descriptions or computer-averaged signals without original or legible copies of the ECG as described in 4.00C2a are not acceptable.

(ii) The effects of drugs or electrolyte abnormalities must be considered as possible noncardiac causes of ECG abnormalities of ventricular repolarization; that is, those involving the ST segment and T wave. If available, the predrug (especially digitalis glycosides) ECG should be submitted.

b. ECGs obtained in conjunction with treadmill, bicycle, or arm exercise tests should meet the following specifications:

(i) ECG reports must include the original calibrated ECG tracings or a legible copy;

(ii) A 12-lead baseline ECG must be recorded in the upright position before exercise;

(iii) A 12-lead ECG should be recorded at the end of each minute of exercise;

(iv) If ECG documentation of the effects of hyperventilation is obtained, the exercise test should be deferred for at least 10 minutes because metabolic changes of hyperventilation may alter the physiologic and ECG-recorded response to exercise;

(v) Post-exercise ECGs should be recorded using a generally accepted protocol consistent with the prevailing state of medical knowledge and clinical practice; and

(vi) All resting, exercise, and recovery ECG strips must have the standardization inscribed on the tracing. The ECG strips should be labeled to indicate the date, the times recorded and the relationship to the stage of the exercise protocol. The speed and grade (treadmill test) or work rate (bicycle or arm ergometric test) should be recorded. The highest level of exercise achieved, heart rate and blood pressure levels during testing, and the reason(s) for terminating the test (including limiting signs or symptoms) must be recorded.

3. What are exercise tests and what are they used for?

a. Exercise tests have you perform physical activity and record how your cardiovascular system responds. Exercise tests usually involve walking on a treadmill, but other forms of exercise, such as an exercise bicycle or an arm exercise machine, may be used. Exercise testing may be done for various reasons, such as to evaluate the severity of your coronary artery disease or peripheral vascular disease or to evaluate your progress after a cardiac procedure or an acute event, like a myocardial infarction (heart attack). Exercise testing is the most widely used testing for identifying the presence of myocardial ischemia and for estimating maximal aerobic capacity (usually expressed in METs—metabolic equivalents) if you have heart disease.

b. We include exercise tolerance test (ETT) criteria in 4.02B2, 4.04A, 4.06B, and 4.08A2. To meet the ETT criteria in these listings, the ETT must be a sign- or symptom-limited test in which you exercise while connected to an ECG until you develop a sign or symptom that indicates that you have exercised as much as is considered safe for you.

c. In 4.12B, we also refer to exercise testing for peripheral vascular disease. In this test, you walk on a treadmill, usually for a specified period of time, and the person who administers the test measures the effect of exercise on the flow of blood in your legs, usually by using ultrasound. The test is also called an exercise Doppler test. Even though this test is intended to evaluate peripheral vascular disease, it will be stopped for your safety if you develop abnormal signs or symptoms because of heart disease.

d. Each type of test is done in a certain way following specific criteria, called a protocol. For our program, we also specify certain aspects of how any exercise test we purchase is to be done. See 4.00C10 and 4.00C17.

4. Do ETTs have limitations? An ETT provides an estimate of aerobic capacity for walking on a grade, bicycling, or moving one's arms in an environmentally controlled setting. Therefore, ETT results do not correlate with the ability to perform other types of exertional activities, such as lifting and carrying heavy loads, and do not provide an estimate of the ability to perform activities required for work in all possible work environments or throughout a workday. Also, certain medications (such as beta blockers) and conduction disorders (such as left or right bundle branch blocks) can cause false-negative or false-positive results. Therefore, we must consider the results of an ETT together with all the other relevant evidence in your case record.

5. How does an ETT with measurement of maximal or peak oxygen uptake (VO₂) differ from other ETTs? Occasionally, medical evidence will include the results of an ETT with VO₂ , which is also called a cardiopulmonary exercise test While ETTs without measurement of VO₂ provide only an estimate of aerobic capacity, measured maximal or peak oxygen uptake provides an accurate measurement of aerobic capacity, which is often expressed in METs (metabolic equivalents). The MET level may not be indicated in the report of attained maximal or peak VO₂ testing, but can be calculated as follows: 1 MET = 3.5 milliliters (ml) of oxygen uptake per kilogram (kg) of body weight per minute. For example, a 70 kg (154 lb.) person who achieves a maximal or peak VO₂ of 1225 ml in 1 minute has attained 5 METs (1225 ml/70 kg/1 min = 17.5 ml/kg/min. 17.5/3.5 = 5 METs). In listings 4.02B2, 4.06B, and 4.08A2, we use the peak VO₂ (oxygen uptake) measurement when evaluating the results of a cardiopulmonary exercise test.

6. When will we consider whether to purchase an exercise test?

a. We will consider whether to purchase an exercise test when:

(i) There is a question whether your cardiovascular disorder meets or medically equals the severity of one of the listings, or there is no timely test in the evidence we have (see 4.00C9), and we cannot find you disabled on some other basis; or

(ii) We need to assess your residual functional capacity and there is insufficient evidence in the record to make a determination or decision.

b. We will not purchase an exercise test when we can make our determination or decision based on the evidence we already have.

7. What must we do before purchasing an exercise test?

a. Before we purchase an exercise test, an MC, preferably one with experience in the care of patients with cardiovascular disease, must review the pertinent history, physical examinations, and laboratory tests that we have to determine whether the test would present a significant risk to you or if there is some other medical reason not to purchase the test (see 4.00C8).

b. If you are under the care of a medical source (see §§ 404.1502 and 416.902 of this chapter) for a cardiovascular disorder, this source has not performed an exercise test, and there are no reported significant risks to testing, we will request a statement from that source explaining why it was not done or should not be done before we decide whether we will purchase the test.

c. The MC, in accordance with the regulations and other instructions on consultative examinations, will generally not override the medical source's conclusion about the risk of exercise testing to you. In the rare situation in which the MC does override the medical source's conclusion, the MC must prepare a written rationale documenting the reasons for overriding the conclusion.

d. If you do not have a medical source or we cannot obtain a statement from your medical source, the MC is responsible for assessing the risk of exercise testing based on a review of the records we have before purchasing an exercise test for you.

e. We must also provide your records to the medical source who performs the exercise test for review prior to conducting the test if the source does not already have them. The medical source who performs the exercise test has the ultimate responsibility for deciding whether you would be at risk.

8. When will we not purchase an exercise test or wait before we purchase an exercise test?

a. We will not purchase an exercise test when an MC finds that you have one of the following significant risk factors:

(i) Unstable angina not previously stabilized by medical treatment;

(ii) Uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise;

(iii) An implanted cardiac defibrillator;

(iv) Symptomatic severe aortic stenosis;

(v) Uncontrolled symptomatic heart failure;

(vi) Aortic dissection;

(vii) Severe pulmonary hypertension (pulmonary artery systolic pressure greater than 60 mmHg);

(viii) Left main coronary stenosis of 50 percent or greater that has not been bypassed;

(ix) Moderate stenotic valvular disease with a systolic gradient across the aortic valve of 50 mmHg or greater;

(x) Severe arterial hypertension (systolic greater than 200 mmHg or diastolic greater than 110 mmHg); or

(xi) Hypertrophic cardiomyopathy with a systolic gradient of 50 mmHg or greater.

b. We also will not purchase an exercise test when you are prevented from performing exercise testing due to another impairment affecting your ability to use your arms and legs.

c. We will not purchase an ETT to document the presence of a cardiac arrhythmia.

d. We will wait to purchase an exercise test until 3 months after you have had one of the following events. This will allow for maximal, attainable restoration of functional capacity.

(i) Acute myocardial infarction;

(ii) Surgical myocardial revascularization (bypass surgery);

(iii) Other open-heart surgical procedures; or

(iv) Percutaneous transluminal coronary angioplasty (PTCA) or percutaneous coronary intervention (PCI) with or without stenting.

e. If you are deconditioned after an extended period of bedrest or inactivity and could improve with activity, or if you are in acute heart failure and are expected to improve with treatment, we will wait an appropriate period of time until you are ready and there are no medical reasons that prevent us from purchasing an exercise test.

9. What do we mean by a “timely” test?

a. We consider exercise test results to be timely for 12 months after the date they are performed, provided there has been no change in your clinical status that may alter the severity of your cardiovascular disorder.

b. However, an exercise test that is older than 12 months, especially an abnormal one, can still provide information important to our adjudication. For example, a test that is more than 12 months old can provide evidence of ischemic heart disease or peripheral vascular disease, information on decreased aerobic capacity, or information about the duration or onset of your impairment. Such tests can be an important component of the longitudinal record.

c. When we evaluate a test that is more than 12 months old, we must consider the results in the context of all the relevant evidence, including why the test was performed and whether there has been an intervening event or improvement or worsening of your impairment.

d. We will purchase a new exercise test only if we cannot make a determination or decision based on the evidence we have.

10. How must ETTs we purchase be performed?

a. The ETT must be a sign- or symptom-limited test characterized by a progressive multistage regimen. It must be performed using a generally accepted protocol consistent with the prevailing state of medical knowledge and clinical practice. A description of the protocol that was followed must be provided, and the test must meet the requirements of 4.00C2b and this section. A radionuclide perfusion scan may be useful for detecting or confirming ischemia when resting ECG abnormalities, medications, or other factors may decrease the accuracy of ECG interpretation of ischemia. (The perfusion imaging is done at the termination of exercise, which may be at a higher MET level than that at which ischemia first occurs. If the imaging confirms the presence of reversible ischemia, the exercise ECG may be useful for detecting the MET level at which ischemia initially appeared.) Exercise tests may also be performed using echocardiography to detect stress-induced ischemia and left ventricular dysfunction (see 4.00C12 and 4.00C13).

b. The exercise test must be paced to your capabilities and be performed following the generally accepted standards for adult exercise test laboratories. With a treadmill test, the speed, grade (incline), and duration of exercise must be recorded for each exercise test stage performed. Other exercise test protocols or techniques should use similar workloads. The exercise protocol may need to be modified in individual cases to allow for a lower initial workload with more slowly graded increments than the standard Bruce protocol.

c. Levels of exercise must be described in terms of workload and duration of each stage; for example, treadmill speed and grade, or bicycle ergometer work rate in kpm/min or watts.

d. The exercise laboratory's physical environment, staffing, and equipment must meet the generally accepted standards for adult exercise test laboratories.

11. How do we evaluate ETT results? We evaluate ETT results on the basis of the work level at which the test becomes abnormal, as documented by onset of signs or symptoms and any ECG or imaging abnormalities. The absence of an ischemic response on an ETT alone does not exclude the diagnosis of ischemic heart disease. We must consider the results of an ETT in the context of all of the other evidence in your case record.

12. When are ETTs done with imaging? When resting ECG abnormalities preclude interpretation of ETT tracings relative to ischemia, a radionuclide (for example, thallium-201 or technetium-99m) perfusion scan or echocardiography in conjunction with an ETT provides better results. You may have resting ECG abnormalities when you have a conduction defect—for example, Wolff-Parkinson-White syndrome, left bundle branch block, left ventricular hypertrophy—or when you are taking digitalis or other antiarrhythmic drugs, or when resting ST changes are present. Also, these techniques can provide a reliable estimate of ejection fraction.

13. Will we purchase ETTs with imaging? We may purchase an ETT with imaging in your case after an MC, preferably one with experience in the care of patients with cardiovascular disease, has reviewed your medical history and physical examination, any report(s) of appropriate medically acceptable imaging, ECGs, and other appropriate tests. We will consider purchasing an ETT with imaging when other information we have is not adequate for us to assess whether you have severe ventricular dysfunction or myocardial ischemia, there is no significant risk involved (see 4.00C8a), and we cannot make our determination or decision based on the evidence we already have.

14. What are drug-induced stress tests? These tests are designed primarily to provide evidence about myocardial ischemia or prior myocardial infarction, but do not require you to exercise. These tests are used when you cannot exercise or cannot exercise enough to achieve the desired cardiac stress. Drug-induced stress tests can also provide evidence about heart chamber dimensions and function; however, these tests do not provide information about your aerobic capacity and cannot be used to help us assess your ability to function. Some of these tests use agents, such as Persantine or adenosine, that dilate the coronary arteries and are used in combination with nuclear agents, such as thallium or technetium (for example, Cardiolyte or Myoview), and a myocardial scan. Other tests use agents, such as dobutamine, that stimulate the heart to contract more forcefully and faster to simulate exercise and are used in combination with a 2-dimensional echocardiogram. We may, when appropriate, purchase a drug-induced stress test to confirm the presence of myocardial ischemia after a review of the evidence in your file by an MC, preferably one with experience in the care of patients with cardiovascular disease.

15. How do we evaluate cardiac catheterization evidence?

a. We will not purchase cardiac catheterization; however, if you have had catheterization, we will make every reasonable effort to obtain the report and any ancillary studies. We will consider the quality and type of data provided and its relevance to the evaluation of your impairment.

b. Cardiac catheterization reports commonly include an evaluation of each main coronary artery and whether there is evidence of obstruction, as well as the grade of obstruction (percent stenosis). Cardiac catheterization reports may include information about the pressures of left and right side of the heart, evidence of coronary artery size and flow patterns, and chamber size. These reports may also include evaluation of left ventricular wall motion, left ventricular ejection fraction (left ventriculography), fractional flow reserve (FFR) (a measure of flow access across an obstruction), and the instantaneous wave-free ratio (iFR) (a measure of stenosis severity).

16. What details should exercise Doppler test reports contain? The reports of exercise Doppler tests must describe the level of exercise; for example, the speed and grade of the treadmill settings, the duration of exercise, changes in the person's condition during exercise (including the presence and location of leg symptoms), and the reasons for stopping exercise if the expected level of exercise was not attained. If the exercise Doppler test was done to evaluate peripheral vascular disease, the report must also provide the blood pressures at the ankle and other pertinent sites measured after exercise, and also provide the time required for the systolic blood pressure to return toward or to the pre-exercise level. The graphic tracings, if available, should also be included with the report. All tracings must be annotated with the standardization used by the testing facility.

17. How must exercise Doppler tests we purchase be performed? When we purchase an exercise Doppler test, you must exercise on a treadmill at 2 mph on a 12 percent grade for up to 5 minutes. The reports must include the information specified in 4.00C16. Because this is an exercise test, we must evaluate whether such testing would put you at significant risk, in accordance with the guidance found in 4.00C6, 4.00C7, and 4.00C8.

D. How do we evaluate chronic heart failure?

1. What is chronic heart failure (chronic HF)?

a. Heart failure is the inability of the heart to pump enough oxygenated blood to body tissues. This syndrome is characterized by symptoms and signs of pulmonary or systemic congestion (fluid retention) or limited cardiac output. Certain laboratory findings of cardiac functional and structural abnormality support the diagnosis of chronic HF. Ejection fraction (EF) is the percentage of the blood in the ventricle actually pumped out with each contraction. EF in heart failure is a continuum ranging from low EF due to muscle dysfunction to preserved EF resulting from high intracardiac pressures. We consider heart failure to be chronic when the condition persists or recurs over time despite treatment. There are two main types of chronic HF:

(i) Heart failure with reduced EF (HFrEF) or predominant systolic dysfunction is characterized by the inability of the heart to contract normally and expel sufficient blood due to a dilated, poorly contracting left ventricle, and

(ii) Heart failure with preserved EF (HFpEF) or predominant diastolic dysfunction is characterized by the inability of the heart to relax and fill normally due to a thickened ventricular muscle, poor ability of the left ventricle to distend, and increased ventricular filling pressure.

b. Chronic HF is considered in these listings as a single category whether due to atherosclerosis (narrowing of the arteries), cardiomyopathy, hypertension, or rheumatic, congenital, or other heart disease. If the chronic HF is the result of primary pulmonary hypertension secondary to disease of the lung, we evaluate your impairment under the listings in 3.00 (for example, 3.09) or 4.00, as appropriate. For the purposes of 4.02B3, a finding of elevated B-type natriuretic peptide (BNP) or N-terminal pro-B-type natriuretic peptide (NT-proBNP) in the blood assists in differentiating chronic HF from non-heart failure symptoms.

2. What evidence of chronic HF do we need?

a. Cardiomegaly or ventricular dysfunction must be present and demonstrated by appropriate medically acceptable imaging, such as cardiac magnetic resonance imaging (MRI), chest x-ray, echocardiography (M-Mode, 2-dimensional, and Doppler), radionuclide studies, or cardiac catheterization.

(i) Abnormal cardiac imaging provides objective measures of both left ventricular function and structural abnormality in heart failure. Examples of abnormal findings include increased left ventricular end-diastolic dimension (LVEDD), decreased EF, increased left atrial chamber size, increased left atrial volume index (LAVI), increased ventricular filling pressures measured at cardiac catheterization, or increased left ventricular wall or septum thickness.

(ii) An LVEDD greater than 6.8 cm for males or 6.1 cm for females, or an EF of 30 percent or less during a period of stability (that is, not during an episode of exacerbation of heart failure) may be associated clinically with systolic dysfunction.

(iii) LAVI is measured in milliliters (ml) indexed to body surface area (BSA) measured in squared meters (m² ). Indexing is a method of standardizing measurements to different body sizes. Diastolic dysfunction may be clinically associated with LAVI of 40 ml, BSA/m² or greater. The imaging report will contain a measurement for the left atrium volume. The index is calculated by dividing the left atrium volume by BSA.

(iv) However, these measurements alone do not reflect your functional capacity, which we evaluate by considering all of the relevant evidence. In some situations, we may need to purchase an ETT to help us assess your functional capacity.

(v) Other findings on appropriate medically acceptable imaging may include increased pulmonary vascular markings, pleural effusion, and pulmonary edema. These findings need not be present on each report, since chronic HF may be controlled by prescribed treatment.

(vi) Other findings on an echocardiogram report (such as an LVEDD indexed to BSA) may be at least of medically equal significance to required findings in the listing criteria. These findings may be evaluated under our medical equivalence policy, as appropriate. See §§ 404.1526 and 416.926 of this chapter.

b. Your medical history and physical examination should describe characteristic symptoms and signs of pulmonary or systemic congestion (fluid retention) or of limited cardiac output associated with the abnormal findings on appropriate medically acceptable imaging. When an acute episode of heart failure is triggered by a remediable factor, such as an arrhythmia, dietary sodium overload, or high altitude, cardiac function may be restored and a chronic impairment may not be present.

(i) Symptoms of congestion or of limited cardiac output include easy fatigue, weakness, shortness of breath (dyspnea), cough, or chest discomfort at rest or with activity. People with chronic HF may also experience shortness of breath upon lying flat (orthopnea) or episodes of shortness of breath that wake them from sleep (paroxysmal nocturnal dyspnea). They may also experience cardiac arrhythmias resulting in palpitations, lightheadedness, or fainting.

(ii) Signs of congestion may include hepatomegaly, ascites, increased jugular venous distention or pressure, rales, peripheral edema, or rapid weight gain. However, these signs need not be found on all examinations because congestion may be controlled by prescribed treatment or may not be present at the time of evaluation.

3. Is it safe for you to have an ETT if you have chronic HF? The presence of chronic HF is not necessarily a contraindication to an ETT, unless you are having an acute episode of heart failure. Measures of cardiac performance are valuable in helping us evaluate your ability to do work-related activities. ETT has been used safely in people with chronic HF. Therefore, we may purchase an ETT for evaluation under 4.02B2 if an MC, preferably one experienced in the care of patients with cardiovascular disease, determines that the test poses no significant risk to you. ST segment changes from digitalis use in the treatment of chronic HF do not preclude the purchase of an ETT. (See 4.00C6 for when we will consider the purchase of an ETT. See 4.00C7-4.00C8 for what we must do before we purchase an ETT and when we will not purchase one.)

4. How do we evaluate chronic HF using 4.02?

a. We must have objective evidence, as described in 4.00D2, that you have chronic HF.

b. To meet the required level of severity for this listing, your impairment must satisfy the requirements of the criteria in A and B or satisfy either C or D.

c. In 4.02B1, we follow a two-part process to evaluate your impairment. Your impairment must satisfy the requirements in the first part of this process before we will move to the second part.

(i) Your impairment satisfies the first part if a medical source has concluded that the performance of an ETT would present a significant risk to you. This medical source, such as a cardiologist, may be providing your care. If your case record does not include a conclusion from a medical source that an ETT would present a significant risk to you, an MC as defined in 4.00A3a may make such a conclusion if evidence in your case record supports it.

(ii) In the second part of the process, we will evaluate activities of daily living (ADL). ADLs include, but are not limited to, such activities as doing household chores, grooming and hygiene, shopping at a grocery store, taking public transportation, or paying bills. We will assess whether you have persistent symptoms of chronic heart failure (for example, easy fatigue, weakness, shortness of breath, or chest discomfort) at rest or with activity that very seriously limit your ability to perform ADLs independently, appropriately, effectively, and on a sustained basis. Even if you are able to perform some ADLs, we may find your ability is very seriously limited and that your impairment satisfies the second part of the evaluation.

d. Listing 4.02B2b requires a decrease in systolic blood pressure below the baseline level or below any systolic pressure reading recorded during exercise. We have this requirement because, normally, systolic blood pressure and heart rate increase gradually with exercise. Decreases in systolic blood pressure below the baseline level that occur during exercise are often associated with ischemia-induced left ventricular dysfunction resulting in decreased cardiac output. However, a blunted response (that is, failure of the systolic blood pressure to rise 10 mmHg or more), particularly in the first 3 minutes of exercise, may be drug-related and is not necessarily associated with left ventricular dysfunction. Also, some people with increased sympathetic responses because of deconditioning or apprehension may increase their systolic blood pressure and heart rate above their baseline level just before and early into exercise. This can be associated with a drop in systolic pressure in early exercise that is not due to left ventricular dysfunction. Therefore, an early decrease in systolic blood pressure must be interpreted within the total context of the test; that is, the presence or absence of symptoms such as lightheadedness, ischemic changes, or arrhythmias on the ECG.

e. How do we evaluate chronic HF treated with a mechanical circulatory support device? We use 4.02D1 to evaluate chronic HF treated with an implanted mechanical circulatory support device (MCSD), such as a left ventricle assistive device (LVAD) or a right ventricle assistive device (RVAD). Implanted MCSDs are intended for long-term circulatory support in helping the heart pump blood. For the purposes of 4.02D1, an MCSD does not include extracorporeal membrane oxygenation (ECMO) or devices using Impella technology. Although these are forms of mechanical circulatory support, we do not include them in 4.02D1 because they are intended only for short-term circulatory support (maximum 30 days), used in a setting of imminent or actual cardiac arrest.

E. How do we evaluate ischemic heart disease?

1. What is ischemic heart disease (IHD)? IHD is a condition in which the heart muscle does not receive enough blood to function normally (ischemia). Ischemia can result when one or more of your coronary arteries is narrowed or obstructed or, in rare situations, constricted due to vasospasm. The obstruction may be the result of an embolus, a thrombus, or plaque. When heart muscle tissue dies as a result of the reduced blood supply, it is called a myocardial infarction (heart attack). In the absence of coronary artery obstruction, ischemia can also occur due to coronary microvascular dysfunction, which results in the heart muscle getting insufficient oxygen.

2. What causes chest discomfort of myocardial origin?

a. Chest discomfort of myocardial ischemic origin, commonly known as angina pectoris, is usually caused by obstructive coronary artery disease (CAD). However, ischemic discomfort may be caused by a noncoronary artery impairment, such as aortic stenosis, hypertrophic cardiomyopathy, pulmonary hypertension, or anemia. Ischemic chest discomfort may also be caused by microvascular coronary artery dysfunction with non-obstructive CAD or in the absence of CAD.

b. Instead of typical angina pectoris, some people with IHD experience atypical angina, anginal equivalent, variant angina, or silent ischemia, all of which we may evaluate using 4.04. We discuss the various manifestations of ischemia in 4.00E3-4.00E7.

3. What are the characteristics of typical angina pectoris? Discomfort of myocardial ischemic origin (angina pectoris) is discomfort that is precipitated by effort or emotion and promptly relieved by rest, sublingual nitroglycerin (that is, nitroglycerin tablets that are placed under the tongue), or other rapidly acting nitrates. Typically, the discomfort is located in the chest (usually substernal) and described as pressing, crushing, squeezing, burning, aching, or oppressive. Sharp, sticking, or cramping discomfort is less common. Discomfort occurring with activity or emotion should be described specifically as to timing and usual inciting factors (type and intensity), character, location, radiation, duration, and response to nitrate treatment or rest.

4. What is atypical angina? Atypical angina describes discomfort or pain from myocardial ischemia that is felt in places other than the chest. The common sites of cardiac pain are the inner aspect of the left arm, neck, jaw(s), upper abdomen, and back, but the discomfort or pain can be elsewhere. When pain of cardiac ischemic origin presents in an atypical site in the absence of chest discomfort, the source of the pain may be difficult to diagnose. To represent atypical angina, your discomfort or pain should have precipitating and relieving factors similar to those of typical chest discomfort, and we must have objective medical evidence of myocardial ischemia; for example, ECG or ETT evidence or appropriate medically acceptable imaging.

5. What is anginal equivalent? Often, people with IHD will complain of shortness of breath (dyspnea) on exertion without chest pain or discomfort. In a minority of such situations, the shortness of breath is due to myocardial ischemia; this is called anginal equivalent. To represent anginal equivalent, your shortness of breath should have precipitating and relieving factors similar to those of typical chest discomfort, and we must have objective medical evidence of myocardial ischemia; for example, ECG or ETT evidence or appropriate medically acceptable imaging. In these situations, it is essential to establish objective evidence of myocardial ischemia to ensure that you do not have effort dyspnea due to non-ischemic or non-cardiac causes.

6. What is variant angina?

a. Variant angina (Prinzmetal's angina, vasospastic angina) refers to the occurrence of anginal episodes at rest, especially at night, accompanied by transitory ST segment elevation (or, at times, ST depression) on an ECG. It is due to severe spasm of a coronary artery, causing ischemia of the heart wall, and is often accompanied by major ventricular arrhythmias, such as ventricular tachycardia. We will consider variant angina under 4.04 only if you have spasm of a coronary artery in relation to an obstructive lesion of the vessel. If you have an arrhythmia as a result of variant angina, we may consider your impairment under 4.05.

b. Variant angina may also occur in the absence of obstructive CAD. In this situation, an ETT will not demonstrate ischemia. The diagnosis will be established by showing the typical transitory ST segment changes during attacks of pain, and the absence of obstructive lesions shown by catheterization. In the absence of obstructive CAD, the treatment of ischemia due to coronary vasospasm or microvascular dysfunction is limited to medications such as calcium channel blockers, statins, and nitrates. In such situations, we will consider the frequency of anginal episodes despite prescribed treatment when evaluating your residual functional capacity.

c. Vasospasm that is catheter-induced during coronary angiography is not variant angina.

7. What is silent ischemia?

a. Myocardial ischemia, and even myocardial infarction, can occur without perception of pain or any other symptoms; when this happens, we call it silent ischemia. Pain sensitivity may be altered by a variety of diseases, most notably diabetes mellitus and other neuropathic disorders. People also vary in their threshold for pain.

b. Silent ischemia occurs most often in:

(i) People with documented past myocardial infarction or established angina without prior infarction who do not have chest pain on ETT, but have a positive test with ischemic abnormality on ECG, perfusion scan, or other appropriate medically acceptable imaging.

(ii) People with documented past myocardial infarction or angina who have ST segment changes on ambulatory monitoring (Holter monitoring) that are similar to those that occur during episodes of angina. ST depression shown on the ambulatory recording should not be interpreted as positive for ischemia unless similar depression is also seen during chest pain episodes annotated in the diary that the person keeps while wearing the Holter monitor.

(iii) People who have diabetes mellitus with neuropathy. People with diabetes mellitus can have a higher threshold for pain because of the neuropathy and may not feel chest pain or discomfort from cardiac ischemia.

c. ST depression can result from a variety of factors, such as postural changes and variations in cardiac sympathetic tone. In addition, there are differences in how different Holter monitors record the electrical responses. Therefore, we do not consider the Holter monitor reliable for the diagnosis of silent ischemia except in the situation described in 4.00E7b(ii).

8. What other sources of chest discomfort are there? Chest discomfort of nonischemic origin may result from other cardiovascular disorders, such as pericarditis. Noncardiac disorders may also produce symptoms mimicking that of myocardial ischemia. These disorders include acute anxiety or panic attacks, gastrointestinal tract disorders (such as esophageal spasm, esophagitis, hiatal hernia, biliary tract disease, gastritis, peptic ulcer, and pancreatitis), and musculoskeletal syndromes (such as chest wall muscle spasm, chest wall syndrome (especially after coronary bypass surgery), costochondritis, and cervical or dorsal spine arthritis). Hyperventilation may also mimic ischemic discomfort. Thus, in the absence of documented myocardial ischemia, such disorders should be considered as possible causes of chest discomfort.

9. How do we evaluate IHD using 4.04?

a. We must have objective evidence, as described under 4.00C, that your symptoms are due to myocardial ischemia.

b. In 4.04A, we need evidence, such as an ECG interpretation, from an acceptable medical source who reviewed your ETT findings and found them positive for ischemia. These ETT findings may include ECG tracings or systolic blood pressure measurements. If your case record does not have such an interpretation from an acceptable medical source, an MC, as defined in 4.00A3a, may review your ETT findings and interpret them as being positive for ischemia if evidence in your case record supports it.

(i) ETT findings may show the classically accepted changes in ECG tracings of horizontal or down sloping ST depression or of ST elevation. For example, ECG tracings may show horizontal or down sloping depression, in the absence of digitalis glycoside treatment or hypokalemia, of the ST segment of at least −0.10 millivolts (−1.0 mm) in at least three consecutive complexes that are on a level baseline in any lead other than a VR, and depression of at least −0.10 millivolts lasting for at least 1 minute of recovery. Alternatively, the ECG tracings may show at least 0.10 millivolt (1 mm) ST elevation above resting baseline in non-infarct leads during both exercise and 1 or more minutes of recovery.

(ii) ETT findings may also show a decrease of 10 mmHg or more in systolic pressure below the baseline systolic blood pressure or the preceding systolic pressure measured during exercise due to left ventricular dysfunction, despite an increase in workload. This finding is the same finding required in 4.02B2b. See 4.00D4d for full details.

c. In 4.04C, each ischemic episode must result in an unplanned hospitalization. Examples of ischemic episodes that may result in unplanned hospitalizations include unplanned revascularizations, myocardial infarctions, unstable angina, or dysrhythmias. Revascularization means angioplasty (with or without stent placement) or bypass surgery.

(i) How do we calculate separate ischemic episodes? Reocclusion that occurs after a revascularization procedure but during the same hospitalization and that requires a second procedure during the same hospitalization will not be counted as another ischemic episode. If you are hospitalized for documented myocardial infarction and have a revascularization procedure during the same hospitalization, this event will be counted as one ischemic episode.

(ii) How do we evaluate ischemic episodes not amenable to revascularizations? If your ischemic episodes are not amenable to revascularization, we will evaluate them using the appropriate listing (for example, 4.04D). Not amenable means that the revascularization procedure could not be done because of another medical impairment or because the vessel was not suitable for revascularization.

d. We will use 4.04D only when you have symptoms due to myocardial ischemia as described in 4.00E3-4.00E7 while on a regimen of prescribed treatment, you are at risk for ETT (see 4.00C8), and we do not have a timely ETT or a timely normal drug-induced stress test for you. See 4.00C9 for what we mean by a timely test.

e. In 4.04D1, fractional flow reserve (FFR) is a measurement of the pressure differences across an obstructive lesion, giving an estimate of the severity of stenosis. An FFR measurement of 1.0 indicates normal blood flow. An FFR measurement equal to or less than 0.80 indicates stenosis capable of producing serious myocardial ischemia in an artery appropriate for revascularization. An FFR measurement that is greater than 0.80 indicates stenosis not likely to produce significant ischemia. FFR also helps define the adequacy of collateral flow that directly affects function in ischemic heart disease.

f. In 4.04D2, instantaneous wave-free ratio (iFR) measures the pressure ratio during a specified period of diastole when the coronary resistance is minimized and stable. An iFR value equal to or less than 0.89 indicates a hemodynamically significant stenosis that is appropriately treated with percutaneous coronary intervention.

g. In 4.04D3 and 4.04D4, the term “nonbypassed” means that the blockage is in a vessel that is potentially bypassable; that is, large enough to be bypassed and considered to be a cause of your ischemia. These vessels are usually major arteries or one of a major artery's major branches. A vessel that has become obstructed again after angioplasty or stent placement and has remained obstructed or is not amenable to another revascularization is considered a nonbypassed vessel for purposes of the listings. When you have had revascularization, we will not use the pre-operative findings to assess the current severity of your coronary artery disease under 4.04D, although we will consider the severity and duration of your impairment before your surgery in making our determination or decision.

F. How do we evaluate arrhythmias?

1. What is an arrhythmia? An arrhythmia is a change in the regular beat of the heart. Your heart may seem to skip a beat or beat irregularly, very quickly (tachycardia), or very slowly (bradycardia). Although we use the term arrhythmia in the listings, the term “dysrhythmia” may also be used in the medical evidence to describe this condition.

2. What are the different types of arrhythmias?

a. There are many types of arrhythmias. Arrhythmias are identified by where they occur in the heart (atria or ventricles) and by what happens to the heart's rhythm when they occur.

b. Arrhythmias arising in the cardiac atria (upper chambers of the heart) are called atrial or supraventricular arrhythmias. Ventricular arrhythmias begin in the ventricles (lower chambers). In general, ventricular arrhythmias caused by heart disease are the most serious.

3. How do we evaluate arrhythmias using 4.05?

a. We will use 4.05 when you have arrhythmias that are not fully controlled by medication, an implanted pacemaker, or an implanted cardiac defibrillator, and you have recurrent episodes of syncope or near syncope. If your arrhythmias are controlled, we will evaluate your underlying heart disease using the appropriate listing. For other considerations when we evaluate arrhythmias in the presence of an implanted cardiac defibrillator, see 4.00F4.

b. We consider near syncope to be a period of altered consciousness, since syncope is a loss of consciousness or a faint. It is not merely a feeling of light-headedness, momentary weakness, or dizziness.

c. For purposes of 4.05, there must be a documented association between the syncope or near syncope and the recurrent arrhythmia. The recurrent arrhythmia, not some other cardiac or non-cardiac disorder, must be established as the cause of the associated symptom. This documentation of the association between the symptoms and the arrhythmia may come from the usual diagnostic methods, including Holter monitoring (also called ambulatory electrocardiography) and tilt-table testing with a concurrent ECG. Although an arrhythmia may be a coincidental finding on an ETT, we will not purchase an ETT to document the presence of a cardiac arrhythmia.

4. What do we consider when you have an implanted cardiac defibrillator and you do not have arrhythmias that meet the requirements of 4.05?

a. Implanted cardiac defibrillators are used to prevent sudden cardiac death in people who have had, or are at high risk for, cardiac arrest from life-threatening ventricular arrhythmias. The largest group at risk for sudden cardiac death consists of people with cardiomyopathy (ischemic or non-ischemic) and reduced ventricular function. However, life-threatening ventricular arrhythmias can also occur in people with little or no ventricular dysfunction. The shock from the implanted cardiac defibrillator rescues a person from what may have been cardiac arrest. However, as a consequence of the shock(s), similar to the effects of treatments for other cardiovascular disease, a person may experience psychological distress, which we may evaluate under the listings in 12.00.

b. Most implantable cardiac defibrillators have rhythm-correcting and pacemaker capabilities. In some people, these functions may result in the termination of ventricular arrhythmias without an otherwise painful shock. (The shock is like being kicked in the chest.) Implanted cardiac defibrillators may deliver inappropriate shocks, often repeatedly, in response to benign arrhythmias or electrical malfunction. Also, exposure to strong electrical or magnetic fields, such as from magnetic resonance imaging, can trigger or reprogram an implanted cardiac defibrillator, resulting in inappropriate shocks. We must consider the frequency of, and the reason(s) for, the shocks when evaluating the severity and duration of your impairment.

c. In general, the exercise limitations imposed on people with an implanted cardiac defibrillator are those dictated by the underlying heart impairment. However, the exercise limitations may be greater when the implanted cardiac defibrillator delivers an inappropriate shock in response to the increase in heart rate with exercise, or when there is exercise-induced ventricular arrhythmia.

G. How do we evaluate peripheral vascular disease?

1. What is peripheral vascular disease (PVD)? Generally, PVD is any impairment that affects either the arteries (peripheral artery disease) or the veins (venous insufficiency) in the extremities, particularly the lower extremities. The usual effect is blockage of the flow of blood either from the heart (arterial) or back to the heart (venous). If you have peripheral artery disease, you may have pain in your leg after walking a distance that goes away when you rest (intermittent claudication); at more advanced stages, you may have pain in your leg or foot at rest or you may develop ulceration or gangrene. Neuropathy may mask these typical symptoms. If you have venous insufficiency, you may have swelling, varicose veins, skin pigmentation changes, or skin ulceration.

2. How do we assess limitations resulting from PVD? We will assess your limitations based on your symptoms together with physical findings and Doppler studies or other appropriate diagnostic techniques. However, if the PVD has resulted in amputation, we will evaluate any limitations related to the amputation under the listings in 1.00.

3. What is brawny edema? Brawny edema (4.11A) is swelling that is usually dense and feels firm due to the presence of increased connective tissue; it is also associated with characteristic skin pigmentation changes. It is not the same thing as pitting edema. Brawny edema generally does not pit (indent on pressure), and the terms are not interchangeable. Pitting edema does not satisfy the requirements of 4.11A.

4. What is lymphedema and how do we evaluate it?

a. Lymphedema is edema of the extremities due to a disorder of the lymphatic circulation; at its worst, it is called elephantiasis. Primary lymphedema is caused by abnormal development of lymph vessels and may be present at birth (congenital lymphedema), but more often develops during the teens (lymphedema praecox). It may also appear later, usually after age 35 (lymphedema tarda). Secondary lymphedema is due to obstruction or destruction of normal lymphatic channels due to tumor, surgery, repeated infections, or parasitic infection such as filariasis. Lymphedema most commonly affects one extremity. Symptoms of lymphedema include but are not limited to swelling in an extremity, changes in skin, and pain or sensory changes in the affected area. The symptoms may limit movement in affected joints.

b. Lymphedema does not meet the requirements of 4.11, although it may medically equal the listing. We evaluate lymphedema by considering whether the underlying cause meets or medically equals any listing, or whether the lymphedema medically equals a cardiovascular disorders listing such as 4.11 or a listing in 1.00 or 14.00. If no listing is met or medically equaled, we evaluate any functional limitations imposed by your lymphedema when we assess your residual functional capacity.

5. When will we purchase exercise Doppler studies for evaluating peripheral artery disease (PAD)? If we need additional evidence of your PAD, we will generally purchase exercise Doppler studies (see 4.00C16 and 4.00C17) when your resting ankle-brachial index is at least 0.50 but less than 0.80, and only rarely when it is 0.80 or above. We will not purchase exercise Doppler testing if you have a disease that results in abnormal arterial calcification or small vessel disease, but will use your resting toe systolic blood pressure or resting toe-brachial index. (See 4.00G7c and 4.00G8.) There are no current medical standards for evaluating exercise toe pressures. Because any exercise test stresses your entire cardiovascular system, we will purchase exercise Doppler studies only after an MC, preferably one with experience in the care of patients with cardiovascular disease, has determined that the test would not present a significant risk to you and that there is no other medical reason not to purchase the test (see 4.00C6, 4.00C7, and 4.00C8).

6. Are there any other studies that are helpful in evaluating PAD? Doppler studies done using a recording ultrasonic Doppler unit and strain-gauge or air plethysmography are other useful tools for evaluating PAD. A recording Doppler, which prints a tracing of the arterial pulse wave in the femoral, popliteal, dorsalis pedis, and posterior tibial arteries, is an evaluation tool that compares waveforms in normal and compromised peripheral blood flow. Qualitative analysis of the Doppler waveforms and plethysmographic tracings is helpful in the overall assessment of the severity of the occlusive disease. Tracings help in assessing severity if you have small vessel disease related to diabetes mellitus or other diseases with similar vascular changes, or diseases causing medial calcifications when ankle pressure is either normal or falsely high. When there is evidence of medial calcification of the ankle arteries or the ankle-brachial index is 0.50 or greater, other appropriate tests for PAD include magnetic resonance angiography, computed tomography angiography, contrast angiography, and graded treadmill tests.

7. How do we evaluate PAD under 4.12?

a. The ankle blood pressure referred to in 4.12A and B is the higher of the pressures recorded from the posterior tibial and dorsalis pedis arteries in the affected leg. The higher pressure recorded from the two sites is the more significant measurement in assessing the extent of arterial insufficiency. Techniques for obtaining ankle systolic blood pressures include Doppler (See 4.00C16 and 4.00C17), plethysmographic studies, or other techniques. We will request any available tracings generated by these studies so that we can review them.

b. In 4.12A, the ankle-brachial index is the ratio of the systolic blood pressure at the ankle to the systolic blood pressure at the brachial artery; both taken at the same time while you are lying on your back. We do not require that the ankle and brachial pressures be taken on the same side of your body. This is because, as with the ankle pressure, we will use the higher brachial systolic pressure measured. The criterion in 4.12A is met when your resting ankle-brachial index is less than 0.50. If your resting ankle-brachial index is 0.50 or above, we will use 4.12B to evaluate the severity of your PAD, unless you also have a disease causing abnormal arterial calcification or small vessel disease, such as diabetes mellitus. See 4.00G7c and 4.00G8.

c. We will use resting toe systolic blood pressures or resting toe-brachial indices (determined the same way as the ankle-brachial index, see 4.00G7b) when you have intermittent claudication and a disease that results in abnormal arterial calcification (for example, Monckeberg's sclerosis or diabetes mellitus) or small vessel disease (for example, diabetes mellitus). These diseases may result in misleadingly high blood pressure readings at the ankle. However, high blood pressures due to vascular changes related to these diseases seldom occur at the toe level. While the criteria in 4.12C and 4.12D are intended primarily for people who have a disease causing abnormal arterial calcification or small vessel disease, we may also use them for evaluating anyone with PAD.

8. How are toe pressures measured? Toe pressures are measured routinely in most vascular laboratories through one of three methods: most frequently, photoplethysmography; less frequently, plethysmography using strain gauge cuffs; and Doppler ultrasound. Toe pressure can also be measured by using any blood pressure cuff that fits snugly around the big toe and is neither too tight nor too loose. A neonatal cuff or a cuff designed for use on fingers or toes can be used in the measurement of toe pressure.

9. How do we use listing 4.12 if you have had a peripheral graft or stenting? Peripheral grafting serves the same purpose as coronary grafting; that is, to bypass a narrow or obstructed arterial segment. If intermittent claudication recurs or persists after peripheral grafting, we may purchase Doppler studies to assess the flow of blood through the bypassed vessel and to establish the current severity of the peripheral artery impairment. However, if you have had peripheral grafting or stenting done for your PAD, we will not use the findings from before the surgery to assess the current severity of your impairment, although we will consider the severity and duration of your impairment prior to your surgery in making our determination or decision.

H. How do we evaluate congenital heart disease?

1. What is congenital heart disease? Congenital heart disease is any abnormality of the heart or the major blood vessels that is present at birth. Congenital heart disease includes abnormal structure of the individual heart chambers, valves, and blood vessels, and abnormal relative relationship of the chambers to each other that alters the normal pattern of blood flow. Surgery in childhood is the usual treatment, and with improving surgical techniques and medical management, more children with congenital heart disease are surviving into adulthood. Rarely, a person with congenital heart disease may not have received the usual surgery in childhood, and later, as an adult, they are no longer a surgical candidate, as for example, in Eisenmenger syndrome.

2. What is Eisenmenger syndrome? Eisenmenger syndrome refers to any surgically untreated congenital heart defect with intracardiac communication that over time leads to pulmonary hypertension, reversal of blood flow, and hypoxemia.

a. Lesions in Eisenmenger syndrome, such as large septal defects, are characterized by elevated pulmonary pressures or a high pulmonary flow rate. In response, the pulmonary blood vessels pathologically change, leading eventually to pulmonary hypertension. Development of Eisenmenger syndrome represents a point at which pulmonary hypertension is irreversible and the cardiac lesion is likely inoperable.

b. Examples of congenital heart disease that if untreated may cause pulmonary vascular disease leading to Eisenmenger syndrome include atrial septal defect (ASD), ventricular septal defect (VSD), and large patent ductus arteriosus (PDA).

3. What is single ventricle? The term “single ventricle” (also known as “single ventricle physiology” or “functional single ventricle”) describes a diverse group of congenital cardiac anomalies sharing the common feature that only one of the two heart ventricles is adequately developed. At birth, one ventricle must functionally do the work of two, pumping blood for both the body (systemic) and the lungs (pulmonary). Because of this feature, the ultimate plan for cardiac reconstruction is similar for most of these anomalies. People with single ventricle will generally undergo staged reconstructive “Fontan procedures,” ultimately resulting in a “Fontan circulation.” Fontan circulation describes the hemodynamic state in which virtually all systemic venous return-blood passively flows directly into the pulmonary arteries via surgical or catheter-placed shunts, without the blood passing through a ventricle. The Fontan circulation results in difficulties augmenting, and sometimes maintaining, cardiac output. Some of the anomalies described as single ventricle include the following:

(a) Hypoplastic left heart syndrome;

(b) Hypoplastic right ventricle;

(c) Tricuspid valve atresia;

(d) Pulmonary atresia with intact ventricular septum;

(e) Double inlet left ventricle; and

(f) Some variations of double outlet right ventricle.

4. How do we evaluate conditions associated with congenital heart disease?

a. We evaluate congenital heart disease that results in chronic heart failure with evidence of ventricular dysfunction or in recurrent arrhythmias under 4.02 or 4.05, respectively. Otherwise, we evaluate your impairment under 4.06.

b. We evaluate pulmonary hypertension due to congenital heart disease under 4.06B or 4.06C. We evaluate pulmonary hypertension not due to congenital heart disease under the listings in 3.00 (for example, 3.09).

c. We need pulse oximetry measurements documented by medical sources using methods consistent with the prevailing state of medical knowledge and clinical practice to evaluate chronic hypoxemia in congenital heart disease under 4.06A3. These pulse oximetry measurements also must be consistent with the other evidence in the case record.

d. We evaluate single ventricle physiology under 4.06D and will consider you disabled if your medical evidence documents that you have any congenital heart disorder that results in single ventricle physiology (functional single ventricle). In addition to the above congenital heart disorders, examples of palliative surgical procedures that indicate single ventricle physiology include the Glenn, Fontan, and Norwood procedures.

I. How do we evaluate other cardiovascular disorders?

1. How do we evaluate hypertension? Hypertension (high blood pressure) over time may significantly raise the pressures in the heart to the point of ineffective heart muscle function known generally as hypertensive heart disease that we can evaluate under 4.02. Other body systems, such as the brain, kidneys, or eyes may also be affected. We evaluate these impairments by reference to the specific body system(s) that is affected. We will also consider any limitations imposed by your hypertension when we assess your residual functional capacity.

2. What is cardiomyopathy and how do we evaluate it ? Cardiomyopathy is a disease of the heart muscle. The heart loses its ability to pump blood (heart failure), and in some instances, heart rhythm is disturbed, leading to irregular heartbeats (arrhythmias). Usually, the exact cause of the muscle damage is never found (idiopathic cardiomyopathy).

a. There are various types of cardiomyopathy, which fall into two major categories: ischemic and nonischemic cardiomyopathy. Ischemic cardiomyopathy typically refers to heart muscle damage that results from coronary artery disease, including heart attacks. Nonischemic cardiomyopathy includes, but is not limited to several types: dilated, hypertrophic, restrictive, and arrhythmogenic. Cardiomyopathy includes hypertrophic cardiomyopathy, endomyocardial fibrosis, or cardiac amyloidosis AL (light-chain) type.

b. We evaluate cardiomyopathy under 4.08. Depending on the underlying cause of the cardiomyopathy or its effects on you, we may also evaluate your cardiomyopathy under 4.02, 4.04, or 4.05. If your cardiomyopathy results in vascular insult to the brain, we may also evaluate it under 11.04.

c. Under 4.08A1a, we need a conclusion from a medical source that the performance of an exercise test would present a significant risk to you. If your case record does not have a conclusion from a medical source that an exercise test would present a significant risk to you, an MC as defined in 4.00A3a may make such a conclusion if evidence in your case record supports it.

3. How do we evaluate valvular heart disease? We evaluate aortic valvular disease under 4.07. We may also evaluate aortic valvular disease, as well as other forms of valvular disease, under 4.02, 4.04, 4.05, 4.06, or a listing in 11.00, depending on its effects on you.

4. What do we consider when we evaluate heart transplant recipients?

a. After your heart transplant, we will consider you disabled under 4.09 for 1 year following the surgery because there is a greater likelihood of rejection of the organ and infection during the first year. If you develop cardiac allograft vasculopathy after your transplant, we will evaluate this impairment under 4.16.

b. However, heart transplant patients generally meet our definition of disability before they undergo transplantation. We will determine the onset of your disability based on the facts in your case.

c. We will not assume that you became disabled when your name was placed on a transplant waiting list. This is because you may be placed on a waiting list soon after diagnosis of the cardiac disorder that may eventually require a transplant. Physicians recognize that candidates for transplantation often have to wait months or even years before a suitable donor heart is found, so they place their patients on the list as soon as permitted.

d. When we do a continuing disability review to determine whether you are still disabled, we will evaluate your residual impairment(s), as shown by the evidence in your case record, including any side effects of medication. We will consider all evidence indicative of cardiac dysfunction in deciding whether medical improvement (as defined in §§ 404.1594 and 416.994 of this chapter) has occurred.

5. What is cardiac allograft vasculopathy and how do we evaluate it? Cardiac allograft vasculopathy (CAV) may affect a person who has received a heart transplant and involves thickening in the walls of the coronary arteries that may progress quickly into serious vascular stenosis and heart dysfunction. Stenosis in CAV is caused by a pathological process different from classic atherosclerosis and treatment often is only palliative. We evaluate CAV under 4.16.

6. When does an aneurysm have “dissection not controlled by prescribed treatment,” as required under 4.10? An aneurysm (or bulge in the aorta or one of its major branches) is dissecting when the inner lining of the artery begins to separate from the arterial wall. We consider the dissection not controlled when you have persistence of chest pain due to progression of the dissection, an increase in the size of the aneurysm, or compression of one or more branches of the aorta supplying the heart, kidneys, brain, or other organs. An aneurysm with dissection can cause heart failure, renal (kidney) failure, or neurological complications. If you have an aneurysm that does not meet the requirements of 4.10 and you have one or more of these associated conditions, we will evaluate the condition(s) using the appropriate listing.

7. What is hyperlipidemia and how do we evaluate it? Hyperlipidemia is the general term for an elevation of any or all of the lipids (fats or cholesterol) in the blood; for example, hypertriglyceridemia, hypercholesterolemia, and hyperlipoproteinemia. These disorders of lipoprotein metabolism and transport can cause defects throughout the body. The effects most likely to interfere with function are those produced by atherosclerosis (narrowing of the arteries) and coronary artery disease. We will evaluate your lipoprotein disorder by considering its effects on you.

8. What is Marfan syndrome and how do we evaluate it?

a. Marfan syndrome is a genetic connective tissue disorder that affects multiple body systems, including the skeleton, eyes, heart, blood vessels, nervous system, skin, and lungs. There is no specific laboratory test to diagnose Marfan syndrome. The diagnosis is generally made by medical history (including family history), physical examination (including an evaluation of the ratio of arm/leg size to trunk size), a slit lamp eye examination, and a heart test(s) (such as an echocardiogram). In some cases, a genetic analysis may be useful, but such analyses may not provide any additional helpful information.

b. The effects of Marfan syndrome can range from mild to severe. In most cases, the disorder progresses as you age. Most people with Marfan syndrome have abnormalities associated with the heart and blood vessels. Your heart's mitral valve may leak, causing a heart murmur. Small leaks may not cause symptoms, but larger ones may cause shortness of breath, fatigue, and palpitations. Another effect is that the wall of the aorta may be weakened and abnormally stretch (aortic dilation). This aortic dilation may tear, dissect, or rupture, causing serious heart problems or sometimes sudden death. We will evaluate the cardiovascular manifestations of your Marfan syndrome under the appropriate criteria, such as 4.10, or, if necessary, consider the functional limitations imposed by your impairment.

c. Other genetic connective tissue disorders, such as Loeys-Dietz syndrome or Ehlers-Danlos syndrome, may have abnormalities associated with the heart and blood vessels. We will evaluate the cardiovascular manifestations of your genetic connective tissue disorder under the appropriate criteria, such as 4.10, or, if necessary, consider the functional limitations imposed by your impairment.

J. How do we evaluate other issues that affect the cardiovascular system?

1. How do we consider the effects of obesity when we evaluate your cardiovascular disorder? Obesity is a medically determinable impairment that may be associated with cardiovascular disorders. The additional body mass may make it harder for the chest and lungs to expand or may cause the heart to work harder to pump blood to carry oxygen to the body. The combined effects of obesity with a cardiovascular disorder can be greater than the effects of each of the impairments considered separately. We consider the additional and cumulative effects of obesity when we determine whether you have a severe cardiovascular disorder, a listing-level cardiovascular disorder, a combination of impairments that medically equals the severity of a listed impairment, and when we assess your residual functional capacity.

2. How do we relate treatment to functional status? In general, conclusions about the severity of a cardiovascular disorder cannot be made on the basis of the type of treatment rendered or anticipated. The amount of function restored and the time required for improvement after treatment (medical, surgical, or a prescribed program of progressive physical activity) vary with the nature and extent of the disorder, the type of treatment, and other factors. 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. See 4.00B4.

3. How do we consider hospitalizations? When we evaluate hospitalizations for chronic heart failure (4.02B3), ischemic heart disease (4.04E), congenital heart disease (4.06E), and cardiomyopathy (4.08D), the hospitalizations do not all have to be for the same cardiovascular disorder(s). They may be for three different exacerbations or complications resulting from your cardiovascular disorder. The hospitalizations must be at least 30 days apart, and each one must last at least 48 hours, including hours in a hospital emergency department immediately before the hospitalization.

K. How do we evaluate cardiovascular disorders that do not meet one of these listings?

1. These listings are only examples of common cardiovascular disorders that we consider severe enough to prevent you from doing any gainful activity. If your impairment(s) does not meet the criteria of any of these listings, we must also consider whether you have an impairment(s) that satisfies the criteria of a listing in another body system.

2. If you have a severe medically determinable impairment(s) that does not meet a listing, we will determine whether your impairment(s) medically equals a listing. See §§ 404.1526 and 416.926 of this chapter. If your impairment(s) does not meet or medically equal a listing, you may or may not have the residual functional capacity to engage in substantial gainful activity. We will proceed to the fourth step and, if necessary, the fifth step of the sequential evaluation process in §§ 404.1520 and 416.920 of this chapter. We will use the rules in §§ 404.1594 or 416.994 of this chapter, as appropriate, when we decide whether you continue to be disabled.

4.01 Category of Impairments, Cardiovascular Disorders

4.02 Chronic heart failure (see 4.00D) while on a regimen of prescribed treatment, with symptoms and signs described in 4.00D2. The required level of severity for this impairment is met when the requirements are satisfied by A and B; or C alone; or D alone.

A. Medically documented presence of one of the following:

1. Heart failure with reduced ejection fraction documented by appropriate medically acceptable imaging during a period of stability (not during an episode of exacerbation of heart failure), with either a. or b.

a. Left ventricular end diastolic dimension greater than 6.8 cm for males or 6.1 cm for females during a period of stability (not during an episode of exacerbation of heart failure); or

b. Ejection fraction of 30 percent or less during a period of stability (not during an episode of exacerbation of heart failure); OR

2. Heart failure with preserved ejection fraction documented by appropriate medically acceptable imaging during a period of stability (not during an episode of exacerbation of heart failure), with either a. or b.

a. Left ventricular posterior wall plus septal thickness totaling 2.5 cm or greater, with an enlarged left atrium greater than or equal to 4.5 cm, or

b. Left atrial volume index (LAVI) greater than or equal to 40 ml, BSA/m² (milliliters to body surface area in squared meters).

AND

B. Resulting in one of the following:

1. Recurrent (see 4.00A3c) symptoms of heart failure, resulting in both a and b:

a. A medical source (see 4.00D4c(i)) has concluded that the performance of an exercise test would present a significant risk to the person; and

b. Very serious limitation in the ability to perform activities of daily living independently, appropriately, effectively, and on a sustained basis; or

2. Inability to perform on an exercise tolerance test at a workload equivalent to 5 METs or less if using a standard treadmill (or bicycle) test without gas exchange, or at 15 ml/kg/min peak VO₂ (oxygen consumption) on a cardiopulmonary exercise test, due to either a or b.

a. Dyspnea, fatigue, palpitations, or chest discomfort; or

b. Decrease of 10 mmHg or more in systolic pressure below the baseline systolic blood pressure or the preceding systolic pressure measured during exercise (see 4.00D4d) due to left ventricular dysfunction, despite an increase in workload; or

3. Exacerbations or complications of chronic heart failure (see 4.00D1b) requiring three hospitalizations within a consecutive 12-month period (see 4.00A3e) and at least 30 days apart. Each hospitalization must last at least 48 hours, including hours in a hospital emergency department immediately before the hospitalization (see 4.00J3);

OR

C. Heart failure with left ventricular ejection fraction of 20 percent or less while on a regimen of prescribed therapy, on two evaluations at least 90 days apart within a consecutive 12-month period (see 4.00A3e) during a period of stability (not during an episode of exacerbation of heart failure);

OR

D. One of the following while hospitalized, at home, or both:

1. An implanted mechanical circulatory support device except extracorporeal membrane oxygenation (ECMO) (see 4.00D4e). Consider under a disability for 1 year from the date of implantation; after that, evaluate any residual impairment(s) under the criteria for the affected body system.

2. Continuous intravenous administration of inotropic medication (for example, milrinone) for at least 30 consecutive days. Consider under a disability for 1 year from the date of initiation of the treatment; after that, evaluate any residual impairment(s) under the criteria for the affected body system.

4.03 [Reserved]

4.04 Ischemic heart disease (see 4.00E), with symptoms due to myocardial ischemia, while on a regimen of prescribed treatment (see 4.00B3 if there is no regimen of prescribed treatment), with A, B, C, D, or E:

A. Inability to perform on an exercise tolerance test at a workload equivalent to 5 METs or less with findings interpreted by an acceptable medical source as positive for ischemia (see 4.00E9b).

OR

B. Ischemic response with exercise or pharmacological (drug-induced) stress testing (see 4.00C14) on medically appropriate imaging, with either 1 or 2:

1. At least two reversible or fixed regional myocardial perfusion defects and either a or b:

a. Transient ischemic dilatation; or

b. Resting left ventricular ejection fraction of less than 50 percent; or

2. At least two reversible or fixed regional wall motion abnormalities and either a or b:

a. Decrease in left ventricular ejection fraction during testing; or

b. Resting left ventricular ejection fraction of less than 50 percent.

OR

C. Documentation of three separate ischemic episodes (see 4.00E9c) requiring unplanned hospitalization (inpatient or observation status) within a consecutive 12-month period (see 4.00A3e).

OR

D. Coronary artery disease, documented by coronary angiography (obtained independently of Social Security disability evaluation) with 1, 2, 3 or 4:

1. Fractional flow reserve (FFR) (see 4.00E9e) measurement of equal to or less than 0.80 of a proximal segment or mid segment coronary artery not amenable to revascularization (see 4.00E9c(ii)).

2. Instantaneous wave-free ratio (iFR) (see 4.00E9f) measurement of equal to or less than 0.89 of a proximal segment or mid segment coronary artery not amenable to revascularization (see 4.00E9c(ii)).

3. History of coronary artery bypass graft surgery with manifestations of ischemia, as described in 4.00E3-4.00E7, while on a regimen of prescribed treatment (see 4.00B3 if there is no regimen of prescribed treatment) with a, b, c, or d:

a. 50 percent or more stenosis of a nonbypassed left main coronary artery; or

b. 70 percent or more stenosis in the proximal segment or mid segment of another nonbypassed coronary artery; or

c. 50 percent or more stenosis in the proximal segment or mid segment of at least two nonbypassed coronary arteries; or

d. 70 percent or more stenosis of a bypass graft vessel.

4. Resting left ventricular ejection fraction of less than 50 percent while medically stable (see 4.00B4) with manifestations of ischemia, as described in 4.00E3-4.00E7, while on a regimen of prescribed treatment (see 4.00B3 if there is no regimen of prescribed treatment) with a, b, or c:

a. 50 percent or more stenosis of a nonbypassed left main coronary artery; or

b. 70 percent stenosis in the proximal segment or mid segment of another nonbypassed coronary artery; or

c. 50 percent or more stenosis in the proximal segment or mid segment of at least two nonbypassed coronary arteries.

OR

E. Exacerbations or complications of ischemic heart disease (see 4.00E2-4.00E7) requiring three hospitalizations within a consecutive 12-month period (see 4.00A3e) and at least 30 days apart. Each hospitalization must last at least 48 hours, including hours in a hospital emergency department immediately before the hospitalization (see 4.00J3).

4.05 Recurrent arrhythmias (see 4.00F), not related to reversible causes such as electrolyte abnormalities or digitalis glycoside or antiarrhythmic drug toxicity, while on a regimen of prescribed treatment (see 4.00B3 if there is no prescribed treatment), demonstrated by both A and B:

A. Coincident with recurrent (see 4.00A3c) episodes of cardiac syncope or near syncope (see 4.00F3b).

AND

B. Documented by either 1 or 2:

1. Resting or ambulatory (Holter) electrocardiography; or

2. Other appropriate medically acceptable testing.

4.06 Congenital heart disease (see 4.00H), documented by appropriate medically acceptable imaging (see 4.00A3d) or cardiac catheterization, with A, B, C, D, or E:

A. Chronic hypoxemia, and 1, 2, or 3:

1. Hematocrit of 55 percent or greater on two evaluations at least 90 days apart within a consecutive 12-month period (see 4.00A3e); or

2. Arterial blood gas test measurement obtained at rest while breathing room air, as described in either a or b:

a. SaO₂ (arterial oxygen saturation) less than or equal to 89 percent; or

b. PO₂ or PaO₂ (partial pressure of oxygen) less than or equal to 60 mmHg; or

3. SpO₂ (percentage of oxygen saturation of blood hemoglobin) measured by pulse oximetry either at rest, during a 6-minute walk test (6MWT), or after a 6MWT, while breathing room air, less than or equal to 87 percent on three evaluations at least 30 days apart within a consecutive 12-month period (see 4.00A3e).

OR

B. Intermittent right-to-left shunting (for example, Eisenmenger syndrome; see 4.00H2) during cardiopulmonary exercise testing while breathing room air, resulting in oxygen desaturation on exertion at a workload equivalent to 5 METs or less, or peak VO₂ (oxygen uptake) of 15.0 ml/kg/min or less, and arterial blood gas test measurement, with either 1 or 2:

1. SaO₂ less than or equal to 89 percent; or

2. PO₂ or PaO₂ less than or equal to 60 mmHg.

OR

C. Pulmonary hypertension documented by cardiac catheterization while medically stable, as described in 1, 2, or 3:

1. Pulmonary arterial systolic pressure elevated to at least 70 percent of the systemic arterial systolic pressure; or

2. Pulmonary arterial systolic pressure equal to or greater than 70 mmHg; or

3. Mean pulmonary artery pressure equal to or greater than 40 mmHg.

OR

D. Single ventricle (with or without Fontan procedures) (see 4.00H3).

OR

E. Exacerbations or complications of congenital heart disease (see 4.00J3) requiring three hospitalizations within a consecutive 12-month period (see 4.00A3e) and at least 30 days apart. Each hospitalization must last at least 48 hours, including hours in a hospital emergency department immediately before the hospitalization (see 4.00J3).

4.07 Aortic valvular disease (see 4.00I3), with symptoms due to stenosis, determined by appropriate test or tests showing an aortic valve area of less than 1.0 cm².

4.08 Cardiomyopathy (see 4.00I2) while on a regimen of prescribed treatment, with A, B, C, or D:

A. Hypertrophic cardiomyopathy documented by appropriate medically acceptable imaging, with left ventricular or septal wall thickness equal to or greater than 20 mm in the absence of other causes of left ventricular hypertrophy (for example, hypertension or aortic valvular disease) and either 1 or 2:

1. Recurrent (see 4.00A3c) symptoms of cardiomyopathy, resulting in both a and b:

a. A medical source (see 4.00I2c) has concluded that the performance of an exercise tolerance test would present a significant risk to the person; and

b. Very serious limitation in the ability to perform activities of daily living independently, appropriately, effectively, and on a sustained basis; or

2. Inability to perform on an exercise tolerance test at a workload equivalent to 5 METs or less if using a standard treadmill (or bicycle) test without gas exchange, or at 15 ml/kg/min peak VO₂ (oxygen consumption) on a cardiopulmonary exercise test.

OR

B. Endomyocardial fibrosis documented by appropriate medically acceptable imaging, with 1, 2, and 3:

1. Loss of chamber volume due to fibrosis of the endocardium of at least one ventricle; and

2. Right or left atrial dilatation (chamber enlargement); and

3. Regurgitant (backward) blood flow through the mitral or tricuspid valve.

OR

C. Cardiac amyloidosis AL (light-chain) type documented by biopsy.

OR

D. Exacerbations or complications of cardiomyopathy requiring three hospitalizations within a consecutive 12-month period (see 4.00A3e) and at least 30 days apart. Each hospitalization must last at least 48 hours, including hours in a hospital emergency department immediately before the hospitalization (see 4.00J3).

4.09 Heart transplantation (see 4.00I4). Consider under a disability for 1 year from the date of the transplant; after that, evaluate the residual impairment(s).

4.10 Dissecting aneurysm of the aorta or major branches (see 4.00I6), due to any cause (for example, atherosclerosis, cystic medial necrosis, Marfan syndrome, or trauma), with A and B:

A. Documented by appropriate medically acceptable imaging.

AND

B. Dissection not controlled by prescribed treatment.

4.11 Chronic venous insufficiency (see 4.00G) of a lower extremity with reflux or obstruction of the venous system documented by duplex ultrasound or other appropriate diagnostic technique, with A or B:

A. Extensive trophic changes of skin (for example, hyperpigmentation, lipodermatosclerosis, brawny edema) involving at least two-thirds of the leg below the knee, on two evaluations at least 90 days apart within a consecutive 12-month period (see 4.00A3e), with both 1 and 2:

1. Consistent with chronic venous insufficiency; and

2. Unresponsive to compression therapy.

OR

B. Two or more episodes of ulceration that have not healed following at least 6 months of prescribed treatment.

4.12 Peripheral artery disease (see 4.00G7) while on a regimen of prescribed treatment resulting in intermittent claudication or leg pain that interferes with mobility (see 4.00G1), with A, B, C, or D, as determined by an appropriate test(s) (see 4.00G5-4.00G6):

A. Resting ankle-brachial index of less than 0.50 (see 4.00G7b).

OR

B. Decrease in systolic blood pressure at the ankle on exercise test (see 4.00G7a) of 50 percent or more of the pre-exercise level and requiring 10 minutes or more to return to pre-exercise level.

OR

C. Resting toe systolic pressure of less than 30 mmHg (see 4.00G7c and 4.00G8).

OR

D. Resting toe-brachial index of less than 0.40 (see 4.00G7c).

4.13-4.15 [Reserved]

4.16 Cardiac allograft vasculopathy (see 4.00I5), documented by appropriate medically acceptable imaging (for example, intravascular ultrasonography or coronary angiography) (see 4.00A3d), with A, B, C, or D:

A. Cardiac index (CI) or cardiac output (CO) less than 2 l/min/m².

OR

B. Left ventricular ejection fraction equal to or less than 45 percent.

OR

C. Right atrial pressure (RAP) greater than 12 mmHg.

OR

D. Pulmonary capillary wedge pressure (PCWP) greater than 15 mmHg.