Date: May 11, 1998

Subject: Fibromyalgia, Chronic Fatigue Syndrome Objective Medical Evidence Requirements for Disability Adjudication

(Your Memo 01/30/98) - REPLY

Commissioner Apfel has asked me to respond to the issues raised in your memorandum dated January 30, 1998. I also have copies of your memoranda addressed to Administrative Appeals Judge Andrew E. Wakshul and General Counsel Arthur Fried, which raise essentially the same issue. This memorandum is also a response to your letters to the General Counsel and Judge Wakshul.

Your letter indicates that the Social Security Administration (SSA) needs to take a definitive position with respect to whether fibromyalgia and chronic fatigue syndrome (CFS) constitute medically determinable impairments. You requested an opinion from OGC on this issue and suggested that the Appeals Council meet en banc or schedule oral argument to resolve the issue.

Although the regulations authorize the Appeals Council to hear oral argument in a case raising an important question of law or policy, the Appeals Council does not establish agency policy with respect to issues related to the evaluation of specific medical conditions. Rather, the office of Disability establishes agency policy is such cases.

Your letter states that fibromyalgia and CFS do not constitute medically determinable impairments within the meaning of section 223(d) (3) of the Social Security Act because there are no acceptable medical criteria by which these impairments can be diagnosed. Your letter further states that " 'symptoms' only become 'signs' when a medically determinable impairment has been established, and subjective 'signs' on examination are therefore not 'objective' evidence in the absence of other objective evidence for providing a predicate for a diagnosis."

However, SSA has taken a definitive position that fibromyalgia and CFS can constitute medically determinable impairments within the meaning of the statute. As you noted in your letter, CFS was discussed in the process unification training in 1996-1997.

Although we regret that you found this discussion inadequate, the training did state clearly and unequivocally that individuals alleging CFS can be found to have a medically determinable impairment under the disability program given the presence of certain specified signs and findings. This position is consistent with the instructions in Program Operations Manual System (POMS) DI 24515.075, Disability Digest No. 93-5, and Social Security Rulings (SSR's) 98-3p, 96-4p. and 96-7p, issued on July 2, 1996, which detail our policies as to how symptoms effect determinations of the presence of a medically determinable impairment, impairment severity, and the ability to engage in sustainable work activity.

Establishing the existence of a medically determinable impairment does not necessarily require that the claimant or the medical evidence establish a specific diagnosis. This is especially true when the medical community has not reached agreement on a single set of diagnostic criteria. All the Act and regulations require is that some physical or mental impairment be established through medically acceptable clinical and laboratory diagnostic techniques. In some cases, the record may not establish the diagnosis, but there will be medical signs established by medically acceptable clinical techniques that show that there is an impairment, and that there is a relationship between the findings and the symptoms alleged; i.e., that the existence of a medically determinable impairment that could reasonably be expected to produce the symptoms has been established.

As you indicated in your letter, with the publication of SSR's 96-4p and 96-7p in July 1996, we intended to emphasize the statutory standard requiring the establishment of a medically determinable impairment as a predicate to the evaluation of symptoms. However, we did not mean to imply that it is first necessary to establish a fixed diagnosis in order to find the presence of a medically determinable impairment. Rather, the medically determinable impairment is established in the presence of anatomical, physiological. or psychological abnormalities that can be objectively observed and reported apart from the individual's perceptions even in the absence of a definitive diagnosis.

Your argument based on the Rulings seems to misinterpret the explanation in Footnote 2 to SSR 96-4p, which explains our longstanding policy consistent with 20 CFR §§. 404.1528(b) and 416.928(b), that some symptoms, when appropriately reported by a physician or psychologist in a clinical setting, can also be considered "signs" because sometimes these observations constitute "medically acceptable clinical diagnostic techniques." This is true for mental impairments in general and for such widely accepted and recognizable disorders as migraine headaches.

CFS is a systemic disorder consisting of a complex of symptoms and signs that may vary in incidence, duration, and severity. The hallmark of CFS is the presence of clinically evaluated, persistent or relapsing chronic fatigue that is of slow or definite onset which cannot be explained by another diagnosed physical or mental disorder, or the result of ongoing exertion. It is not substantially alleviated by rest and results in substantial reduction in previous levels of occupational, educational, social, or personal activities. Within these parameters, CFS can exhibit a variety of symptoms and signs.

As with all claims for disability, documentation of objective physical and/or mental findings in cases involving CFS is critical to establish the presence of a medically determinable impairment. In cases in which CFS is alleged, longitudinal clinical records reflecting ongoing medical assessment and treatment from the individual's medical sources, especially treating sources, are imperative to document objective physical and/or mental findings. Every reasonable effort should be made to secure all relevant evidence in cases involving CFS to ensure appropriate and thorough disability evaluation

For purposes of Social Security disability evaluation, one or the more of the following medical signs clinically documented over a period of at least 6 consecutive months establishes the existence of a medically determinable impairment for individuals alleging disability on the basis of CFS:

• episodes of clinically documented low-grade fever
• palpably swollen and tender lymph nodes on physical examination
• nonexudative pharyngitis
• muscle wasting with no other direct cause identified

At this time, there are no specific laboratory findings that definitively document the presence of CFS. The results of tilt- table testing to evaluate neurally mediated hypotension may be abnormal in individuals with CFS. Nonspecific laboratory findings indicative of chronic immune system activation (e.g., slight elevations in immune complexes, depressed natural killer cell activity, or atypical lymphocytes) may he included in the evidentiary record of individuals alleging CFS, but such findings are not definitive of CFS nor are they necessarily evidence of a medically determinable impairment.

Some individuals with CFS report problems with neurocognitive functioning, including problems with short-term memory, comprehension, concentration, speech, and/or calculation. Other individuals with CFS may exhibit signs of a mental or emotional disorder, such as anxiety or depression. When deficits in these areas have been documented by mental status examination and/or

psychological testing, such findings constitute medical signs that establish the presence of a medically determinable impairment

If an adjudicator concludes that an individual has a medically determinable impairment, and the individual alleges severe fatigue on a recurring basis consistent with CFS, such fatigue must be considered in deciding whether the individual's impairment is severe. If chronic fatigue is found to significantly limit an individual's ability to perform basic work activities, a "severe" impairment must be found to exist at step 2 of the sequential evaluation process. Although symptoms alone cannot be the basis for finding a medically determinable impairment, an individual's symptoms and the effects of those symptoms on the individual's functional abilities must be considered both in determining impairment severity and in assessing the individual's residual functional capacity.

Fibromyalgia is a disorder defined by the American College of Rheumatology (ACR) and we recognize it as medically determinable if there are signs that are clinically established by the medical record. The signs are primarily the tender points. The ACR defines the disorder in patients as "widespread pain in all four quadrants of the body for a minimum duration of 3 months and at least 11 of the 18 specified tender points which cluster around the neck and shoulder, chest, hip, knee, and elbow regions." Other typical symptoms, some of which can be signs if they have been clinically documented over time, are irritable bowel syndrome, chronic headaches, temporomandibular joint dysfunction, sleep disorder, severe fatigue, and cognitive dysfunction.

I agree with your observation that we need to do a better job of explaining our policy with respect to the adjudication of claims involving impairments like fibromyalgia and CFS. Toward that end, we have been drafting policy guidance to help adjudicators evaluate these impairments.

I trust that this explanation and clarification will assist you in applying the regulations and rulings to cases involving fibromyalgia and CFS.

(Signed)

Susan M. Daniels, Ph.D.