PART A. DISEASE AND DISABILITY/SEVERITY DEFINITIONS:

DISEASE PAYMENT OPTION 1
GENERAL GUIDELINES

The following are general guidelines, which are adopted from and are intended to be applied consistently with the Revised Settlement Program and interpretations thereof, to be used in the submission and evaluation of a Claim for compensation under Disease Payment Option I:

There are two ways to document a claim for Disease Payment Option I compensation:

(a) a Claimant can provide a statement or diagnosis from a physician Board- certified in an appropriate specialty, together with the medical records upon which that statement or diagnosis is based or

(b) a Claimant can provide the medical records that, themselves, will enable the Claims Office to place the Claimant on the Disease Payment Option I Schedule.

A Claimant should submit all records that contain information relevant to the criteria for Disease Payment Option I, including

(1) records relating to the relevant signs, symptoms, findings and test results set forth in Disease Payment Option 1 and

(2) records showing the severity of a Claimant's disease or, if applicable, a determination of disability level by either a Qualified Medical Doctor or the Claimant's treating physician.

In general, whatever the physician relied upon in arriving at the diagnosis and findings in the statement or diagnosis should be provided. Typically, this might include a patient questionnaire, physical findings obtained from an assistant's notes in the office chart, and certain lab or other test reports. If the doctor needed to review earlier medical records obtained from other physicians to make a definitive statement about the Claimant's condition or disability, then those records must also, if available, be submitted. If, however, based on an examination of the Claimant, the physician has first-hand knowledge of everything that is the basis for his or her opinion, and the statement or diagnosis sets out that knowledge in sufficient detail, it is possible that no additional records will be required.

As used herein, the term "Qualified Medical Doctor" or "QMD" means a physician who is Board-certified (not Board-eligible) in internal medicine, rheumatology (a sub-specialty of internal medicine), neurology, neurological surgery, or immunology who prepares the statement or diagnosis that the Claimant must file in support of a Disease Payment Option I Claim. Only a Board-certified physician can submit the statement or diagnosis of one of the compensable diseases included in Disease Payment Option I.

The physician writing a statement or diagnosis of one of the compensable diseases in Disease Payment Option I must be Board-certified in an appropriate specialty. The type of specialty depends on the complaints and symptoms with which a Claimant presents. A Claimant or her counsel who believes that another specialty should appropriately be authorized to submit statements or diagnoses for one or more of the listed diseases in Disease Payment Option I should provide the Claims Office with sufficient information to substantiate the belief.

The credentials of individual physicians should not be submitted because the Claims Office can only approve medical specialties, not specific doctors. Important information that should be submitted includes the subject matters covered by that particular specialty examination, as well as the education and training required for qualification. "Board-certified" means certification in a particular medical specialty by the American Board of Medical Specialists. A Doctor of Osteopathy can be a Qualified Medical Doctor if he or she is Board- certified by the same Board that certifies Medical Doctors. A Doctor of Osteopathy may also submit diagnoses or disease compensation claims so long as his or her certification is within an appropriate specialty.

The Claims Office is authorized to determine whether physicians in other countries have degrees or certifications that are the equivalent of those accorded in the United States and should therefore be treated as Qualified Medical Doctors. Physicians who believe that their credentials are the equivalent of Board certification should submit material in support of that belief to the Claims Office. As the Claims Office makes these decisions, the information will be made available to all interested Claimants.

As used herein, the term "treating physician" is one who has seen, examined, and treated the Claimant on several occasions, and not a doctor whom the Claimant has seen only for purposes of getting an evaluation to make a claim under this Disease Payment Option. Treating physician includes a Qualified Medical Doctor if such Qualified Medical Doctor states that he or she has the information necessary to form a professional opinion about the Claimant's disability and sets forth in the statement or diagnosis (or in a supplemental statement) the information upon which that opinion is based and the source of that information.

As used herein, the term "documented" means that it is based on some reliable information other than simply the Claimant's complaint or oral history. For some symptoms, "documented" means that the physician has verified the symptom on physical examination or through a lab test. For others, primarily those that are entirely subjective, it can mean that the physician has performed a physical examination and questioned the Claimant sufficiently to be able to form a professional opinion, utilizing all that doctor's knowledge and training, that the complaint is a valid one. (In this situation, it is important that the physician relying on these complaints does not qualify the diagnosis by stating that these "findings" are based solely on the patient's history given at the time of the single visit to the Board-certified specialist.

The physician needs to feel confident in concluding that the problems do indeed exist.) "Documented" can also mean that written notations of that symptom are found several places in the Claimant's medical records. Thus, to show that a symptom is "documented," a Claimant can submit

  • (1) proof of verification of the symptom through physical examination;

  • (2) a statement from the Claimant's QMD revealing that (s)he questioned the Claimant sufficiently about the symptom and concluded that the complaint is valid; or

  • (3) medical records reflecting that the Claimant had complained about this symptom on other occasions.

    To the extent the severity of a Claimant's disease is based on a disability rating, as defined herein, the Claimant must submit all of the records that the physician relied upon in making his or her disability determination. This would include, as an example, any disability questionnaire that the Claimant completed in order to assist in the physician's determination. A non-Board- certified treating physician can provide a disability determination.

    In preparing submissions for Disease and Disability Option 1 and in curing any deficiencies that may be noted when the submission is processed, Claimants and their physicians (and their counsel if applicable) should be aware that the disability must be related to the compensable condition. That is, the pain must be due to the Claimant's Atypical Connective Tissue Disease or Atypical Neurological Disease. Thus, a threshold requirement in evaluating a disability submission is whether the Claimant's qualifying symptoms are ones such as alopecia, chronic fatigue, or loss of breast function that normally have no pain component.

    A disability determination cannot be approved unless there is evidence that the Claimant is experiencing pain from at least one of her qualifying symptoms or unless the Claimant, in response to a deficiency determination, supplies evidence that she has an additional qualifying symptom that does cause pain. In addition, Claimants and their physicians (and their counsel if applicable) should be aware that a "C" level disability requires that the pain be "regular or recurring." Thus, if a Claimant's pain is described in her records as being only "mild" or "slight," the disability determination will not be approved.

    With respect to a claim for a "B" level disability, the claim must be based on severe pain or an inability to do certain activities. In order to qualify, there must be pain-producing symptoms that result in severe pain on a regular or recurring basis. Generalized statements about "severe pain" may not be enough. The Claims Office must be able to verify that the Atypical Connective Tissue Disease or Atypical Neurological Disease symptoms themselves are the cause of the severe pain.

    If the "B" level disability claim is based on limitations on a Claimant's activities, the claim submission must provide information concerning the activities that are limited. A conclusory statement, with no information about the Claimant and her limitations, will result in a deficiency being assigned. The disability assessment must demonstrate a connection between the specific activities that the Claimant can no longer perform. The disability must be due to the compensable condition. The Claims Office must have enough information about what the limitations are and the cause of those limitations to be able to verify that the Claimant's condition indeed meets the requirements for a "B" disability level.

    In preparing a claim for an "A" level disability, Claimant's and their physicians (and their counsel, if applicable) should be aware that the definition of this assigned disability level is a difficult one to meet. A Claimant must be unable to do any of her normal activities or only be able to do a very few of them. In preparing a submission, it should be reviewed to determine whether there is enough description of the Claimant's daily life and limitations to allow a reader to know that she does indeed meet this strict definition of total disability.

    In addition, it must be clear that the Claimant's total disability is due to the symptoms of the applicable disease or condition. Generalized statements by the QMD that track the disease and disability language cannot replace the responsibility of the Claims Office to review, on a detailed level, all of the claim documentation provided. If the Breast Implant Claimant's Qualified Medical Doctor determines that her death or total disability is clearly and specifically caused by a disease or occurrence other than the compensable disease, she will not be eligible for compensation in Severity/Disability Category A.

    ATYPICAL CONNECTIVE TISSUE DISEASE (ACTD)
    ATYPICAL RHEUMATIC SYNDROME (ARS)
    NON-SPECIFIC AUTOIMMUNE CONDITION (NAC)

    1. This category will provide compensation for Breast Implant Claimants experiencing symptoms that are commonly found in autoimmune or rheumatic diseases but which are not otherwise classified in any of the other compensable disease categories. This category does not include individuals who have been diagnosed with classical rheumatoid arthritis in accordance with ACR criteria, but will include individuals diagnosed with undifferentiated connective tissue disease (UCTD). However, such inclusion is not intended to exclude from this category persons who do not meet the definition of UCTD, it being intended that individuals not meeting the classic definitions of UCTD will be compensated pursuant to the provisions contained herein relative to ACTD, ARS, and NAC.

    2. As with other individuals who fit within this disease compensation program, the fact that a breast implant recipient has been in the past mis-diagnosed with classic rheumatoid arthritis or the fact that the symptoms of classic rheumatoid arthritis may coexist with other symptoms will not exclude the individual from compensation herein. Persons who meet the criteria below and may have a diagnosis of atypical rheumatoid arthritis will not be excluded from compensation under this category.

    3. Eligibility criteria and compensation levels for eligible Breast Implant Claimants are set forth below in the Compensation Categories, which classify individuals in accordance with the following groups of symptoms. If the Breast Implant Claimant's Qualified Medical Doctor determines that a symptom is clearly and specifically caused by a source other than breast implants, that symptom will not be utilized in the diagnosis of Atypical Connective Tissue Disease/Atypical Rheumatic Syndrome unless the Claims Office determines that other submissions indicate that the symptom should be utilized. A symptom that may be caused only in part by a source other than breast implants is not excluded from such utilization.

    4. A diagnosis of ACTD, ARS, or NAC must satisfy one of the following sets of criteria:

  • any two of the three signs and symptoms listed in 5(a) (Group I)

  • any one of the three signs and symptoms listed in 5(a) (Group I), plus any one of the ten signs and symptoms listed in 5(b) (Group II)

  • any three of the ten signs and symptoms listed in 5(b) (Group II)

  • any two of the ten signs and symptoms listed in 5(b) (Group II), plus any one additional (nonduplicative) sign or symptom from the eighteen listed in 5(c) (Group III)

  • five nonduplicative signs or symptoms listed in 5(a) (Group I), 5(b) (Group II), or 5(c) (Group III)

    5. Symptom Groupings:

    (a) Group I Signs and Symptoms:

  • Raynaud's phenomenon evidenced by the patient giving a history of two color changes, or visual evidence of vasospasm, or evidence of digital ulceration

  • Polyarthritis defined as synovial swelling and tenderness in three or more joints lasting greater than six weeks and observed by a physician

  • Keratoconjunctivitis Sicca: subjective complaints of dry eyes and/or dry mouth, accompanied by any one of the following:

  • lacrimal or salivary enlargement

  • parotid enlargement

  • abnormal Schirmer test

  • abnormal Rose-Bengal staining

  • filamentous keratitis

  • abnormal parotid scan or ultrasound

  • abnormal CT or MRI of parotid

  • abnormal labial salivary biopsy

    (b) Group II Signs and Symptoms:

  • Myalgias determined by tenderness on examination

  • Immune mediated skin changes or rash as follows:

  • changes in texture or rashes that may or may not be characteristic of SLE, Systemic Sclerosis (scleroderma), or dermatomyositis diffuse petechiae, telangiectasias, or livedo reticularis

  • Pulmonary symptoms or abnormalities, which may or may not be characteristic of SLE, Systemic Sclerosis (scleroderma), or Sjogren's Syndrome, as follows:
  • pleural and/or interstitial lung disease

  • restrictive lung disease

  • obstructive lung disease as evidenced by characteristic clinical findings and either: characteristic chest X-ray changes or characteristic pulmonary function test abnormalities in a non- smoker (e.g. decreased DLCO or abnormal arterial blood gases)

  • Pericarditis defined by consistent clinical findings and either EKG or echocardiogram

  • Neuropsychiatric symptoms: cognitive dysfunction (memory loss and/or difficulty concentrating) which may be characteristic of SLE or MCTD as determined by a SPECT scan or PET scan or MRI or EEG or neuropsychological testing

  • Peripheral neuropathy diagnosed by physical examination showing one or more of the following:

  • loss of sensation to pinprick, vibration, touch, or position

  • tingling, paresthesia or burning pain in the extremities

  • loss of tendon reflex

    proximal or distal muscle weakness (loss of muscle strength in extremities or weakness of ankles, hands, or foot drop)

  • Signs of dysesthesia

  • entrapment neuropathies

  • Myositis or myopathy:

  • diagnosed by weakness on physical examination or by muscle strength testing

  • abnormal CPK or aldolase

  • abnormal cybex testing

  • abnormal EMG

  • abnormal muscle biopsy

  • Serologic abnormalities -- any one of the following:

  • ANA > or equal to 1:40 positive ANA profile such as Anti-DNA, SSA, SSB, RNP, SM, Scl-70, centromere, Jo-1, PM-Scl or dsDNA (preferable to use ELISA with standard cutoffs)

  • other autoantibodies, including thyroid antibodies, anti-microsomal, or anti- cardiolipin, or RF (by nephelometry with 40 IU cutoff)

  • elevation of immunoglobulin (IgG, IgA, IgM)

  • serologic evidence of inflammation such as elevated ESR, CRP

  • Lymphadenopathy (as defined by at least 1 lymph node greater than or equal to 1x1 cm) documented by a physician (check your consultation prior to explant; the P/S should examined for enlargened lymph nodes in the axilla or underarms)

  • Dysphagia with positive cine-esophagram, manometry or equivalent imaging

    (c) Group III Signs and Symptoms:

  • Documented arthralgia (joint pain)

  • Documented Myalgias (diffuse muscle pain/aching, hurting with verified tender points)

  • Chronic fatigue (lasting over six months)

  • Lymphadenopathy (swollen lymph nodes of 1 cm or more, normally axilla)

  • Documented Neurological symptoms including cognitive dysfunction or paresthesia

  • Photosensitivity (sensitivity to sun light)

  • Sicca symptoms (dry mouth, eyes [see how documented elsewhere] &/or vagina)

  • Dysphagia (trouble swallowing; see how documented elsewhere)

  • Alopecia (hair loss even if peculiar like me; lower 1/2 legs)

  • Sustained balance disturbances

  • Documented sleep disturbances

  • Easy bruisability or bleeding disorder

  • Chronic cystitis or bladder irritability

  • Colitis or bowel irritability

  • Persistent low grade fever or night sweats

  • Mucosal ulcers confirmed by physician (if you have one, go see doctor immediately as it must be observed by MD or DO)

  • Burning pain in the chest, breast, arms or axilla, or substantial loss of function in breast due to disfigurement or other complications from implants or explantation

  • Pathological findings: granulomas or siliconomas or chronic inflammatory response, or breast infections (see your pathology report)

    6. Severity/Disability Compensation Categories

    The compensation level for ACTD/ARS/NAC will be based on the degree to which the individual is "disabled" by the condition, as the individual's treating physician determines in accordance with the following guidelines. The determination of disability under these guidelines will be based on the cumulative effect of the symptoms on the individual's ability to perform her vocational,(4) avocational,(5) or usual self-care(6) activities. In evaluating the effect of the Breast Implant Claimant's symptoms, the treating physicians will take into account the level of pain and fatigue resulting from the symptoms. The disability percentages appearing below are not intended to be applied with numerical precision, but are, instead, intended to serve as a guideline for the physician in the exercise of his or her professional judgment.

  • A. Death or total disability resulting from the compensable condition. An individual will be considered totally disabled if she demonstrates a functional capacity adequate to consistently perform none or only few of the usual duties or activities of vocation or self-care (100%).

  • B. A Breast Implant Claimant will be eligible for category B compensation if she is 35 percent (to 99%) disabled due to the compensable condition. An individual shall be considered 35 percent disabled if she demonstrates a loss of functional capacity which renders her unable to perform some of her usual activities of vocation, avocation, and self-care, or she can perform them only with regular or recurring severe pain.

  • C. A Breast Implant Claimant will be eligible for category C compensation if she is 20 percent (to 34%) disabled due to the compensable condition. An individual shall be considered 20 percent disabled if she can perform some of her usual activities of vocation, avocation, and self-care only with regular or recurring moderate pain.

    fixed:

    C or 20% = $10,000 w/premium (if you believe tooth fairy; $12,000)

    B or 25% = $20,000 ( " " $24,000)

    A or 100% = $50,000 ( " " $60,000)

    ATYPICAL NEUROLOGICAL DISEASE SYNDROME (ANDS)

    1. A diagnosis of Atypical Neurological Disease Syndrome (ANDS) shall be based upon the clinical findings and laboratory tests set forth below. The clinical and laboratory presentation of these neurological syndromes will have an atypical presentation from the natural disease and will also have additional neuromuscular, rheumatological or nonspecific autoimmune signs and symptoms.

    2. Eligibility for Atypical Neurological Disease Syndrome requires both:

  • satisfying the requirements for one of the four neurological diseases set forth in paragraph 5 below, and

  • any three additional (nonduplicative) neuromuscular, rheumatic, or nonspecific \symptoms or findings set forth in the definition for Atypical Connective Tissue Disease (ACTD).

    3. An individual will fit into this category if her primary symptoms are characteristic of a neurological disease as diagnosed by a Board-certified neurologist or by a physician Board-certified in internal medicine.

    4. If the individual's Qualified Medical Doctor determines that a symptom is clearly and specifically caused by a source other than breast implants, that symptom will not be utilized in the diagnosis of Atypical Neurological Disease Syndrome unless the Claims Office determines that other submissions indicate that the symptom should be utilized. A symptom that may be caused only in part by a source other than breast implants is not excluded from such utilization.

    5. Neurological disease types: Polyneuropathies.

    This disease category requires either

  • (1) a diagnosis of a polyneuropathy that is confirmed by one or more of the following or
  • (2) submission of sufficient evidence of, and the required findings confirming, such condition:

  • Objectively-demonstrated loss of sensation to pinprick, vibration, touch, or position

  • Proximal or distal muscle weakness

  • Tingling and/or burning pain in the extremities

  • Signs of dysesthesia

  • Loss of tendon reflex

    Plus one or more of the following laboratory findings:

  • Abnormal levels of anti-mag or anti-sulfatide or anti-GM1 antibodies

  • Abnormal sural nerve biopsy
  • Abnormal electrodiagnostic testing (EMG or nerve conduction studies, etc.)
  • Multiple Sclerosis-like Syndrome. This disease category requires definite evidence of central nervous system disease, with history and physical findings compatible with Multiple Sclerosis or Multiple Sclerosis-like syndrome, involving one or more of the following signs and symptoms:
  • Weakness in the pyramidal distribution

  • Evidence of optic neuritis documented by ophthalmologist

  • Increased Deep Tendon reflexes

  • Absent superficial abdominal reflexes

  • Ataxia or dysdiadochokinesia as the sign of cerebellar involvement

  • Neurologically induced tremors

  • Internuclear ophthalmoplegia and/or bladder or speech involvement secondary to central nervous system disease

    Plus one or more of the following:

  • Abnormal Brain MRI with foci of increased signal abnormality suggestive of demyelinating lesions

  • Delayed visual evoked responses or abnormal evoked potentials

  • Abnormal CSF with oligoclonal bands

  • ALS-like Syndrome. This disease category requires documented evidence of progressive upper and widespread lower motor neuron disease and/or bulbar involvement, plus one or more of the following:

  • Neurological autoantibodies such as anti-mag, anti-sulfatide, anti-GM1
  • Abnormal sural nerve biopsy
  • Chronic inflammation on muscle or nerve biopsies
  • Abnormal EMG
  • Documentation on neurological exam of both upper and lower motor neuron disease and/or bulbar involvement

    Disease of Neuromuscular Junction. This disease category requires either (1) a diagnosis of Myasthenia Gravis or Myasthenia Gravis-like syndrome or disorders of the NMJ, made by a Board-certified neurologist and confirmed by abnormal EMG showing typical findings of decrement on repetitive stimulation testing and/or elevated acetylcholine receptor antibodies or (2) submission of sufficient evidence of, and the required findings confirming, such condition.

    6. Severity/Disability Compensation Categories.

    The compensation level for ANDS will be based on the degree to which the individual is "disabled" by the condition, as the individual's treating physician determines in accordance with the following guidelines. The determination of disability under these guidelines will be based on the cumulative effect of the symptoms on the individual's ability to perform her vocational,

  • (1) avocational,
  • (2) or usual self-care,
  • (3) activities.

    In evaluating the effect of the individual's symptoms, the treating physicians will take into account the level of pain and fatigue resulting from the symptoms. The disability percentages appearing below are not intended to be applied with numerical precision, but are, instead, intended to serve as a guideline for the physician in the exercise of his or her professional judgment.

    A. Death or total disability due to the compensable condition. An individual shall be considered totally disabled if she demonstrates a functional capacity adequate to consistently perform none or only few of the usual duties or activities of vocation or self-care.

    B. A Breast Implant Claimant will be eligible for category B compensation if she is 35 percent disabled due to the compensable condition. An individual shall be considered 35 percent disabled if she demonstrates a loss of functional capacity which renders her unable to perform some of her usual activities of vocation, avocation, and self-care, or if she can only perform them only with regular or recurring severe pain.

    C. A Breast Implant Claimant will be eligible for category C compensation if she is 20 percent disabled due to the compensable condition. An individual shall be considered 20 percent disabled if she can perform some of her usual activities of vocation, avocation, and self-care only with regular or recurring moderate pain.

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