Guidelines To Estimate Probability Of Causation - ECFR

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  1. Title 42 —Public Health
  2. Chapter I —Public Health Service, Department of Health and Human Services
  3. Subchapter G —Occupational Safety and Health Research and Related Activities
  4. Part 81 —Guidelines for Determining Probability of Causation Under the Energy Employees Occupational Illness Compensation Program Act of 2000
  5. Subpart E
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    Subpart EGuidelines To Estimate Probability of Causation81.20 – 81.25
    § 81.20Required use of NIOSH-IREP.
    § 81.21Cancers requiring the use of NIOSH-IREP.
    § 81.22General guidelines for use of NIOSH-IREP.
    § 81.23Guidelines for cancers for which primary site is unknown.
    § 81.24Guidelines for leukemia.
    § 81.25Guidelines for claims including two or more primary cancers.
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    URL https://www.ecfr.gov/current/title-42/part-81/subpart-E Citation 42 CFR Part 81 Subpart E Agency Public Health Service, Department of Health and Human Services Part 81

    Authority:

    42 U.S.C. 7384n(c); E.O. 13179, 65 FR 77487, 3 CFR, 2000 Comp., p. 321.

    Source:

    67 FR 22309, May 2, 2002, unless otherwise noted.

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Subpart E—Guidelines To Estimate Probability of Causation

§ 81.20 Required use of NIOSH-IREP.

(a) NIOSH-IREP is an interactive software program for estimating probability of causation for covered employees seeking compensation for cancer under EEOICPA, other than as members of the Special Exposure Cohort seeking compensation for a specified cancer.

(b) DOL is required to use NIOSH-IREP to estimate probability of causation for all cancers, as identified under §§ 81.21 and 81.23.

§ 81.21 Cancers requiring the use of NIOSH-IREP.

(a) DOL will calculate probability of causation for all cancers using NIOSH-IREP.

(b) Carcinoma in situ (ICD-10-CM codes D00-D09), neoplasms of uncertain behavior (ICD-10-CM codes D37-D44 and D48), and neoplasms of unspecified nature (ICD-10-CM code D49) are assumed to be malignant, for purposes of estimating probability of causation.

(c) All secondary and unspecified cancers of the lymph node (ICD-10-CM codes C77 and C7B.01) shall be considered secondary cancers (cancers resulting from metastasis of cancer from a primary site). For claims identifying cancers of the lymph node, Table 1 in § 81.23(a) provides guidance for assigning a primary site and calculating probability of causation using NIOSH-IREP.

[84 FR 37590, Aug. 1, 2019]

§ 81.22 General guidelines for use of NIOSH-IREP.

DOL will use procedures specified in the NIOSH-IREP Operating Guide to calculate probability of causation estimates under EEOICPA. The guide provides current, step-by-step instructions for the operation of IREP. The procedures include entering personal, diagnostic, and exposure data; setting/confirming appropriate values for variables used in calculations; conducting the calculation; and, obtaining, evaluating, and reporting results.

§ 81.23 Guidelines for cancers for which primary site is unknown.

(a) In claims for which the primary cancer site cannot be determined, but a site of metastasis is known, DOL will calculate probability of causation estimates for various likely primary sites. Table 1 of this paragraph (a) indicates the primary cancer site(s) DOL will use in NIOSH-IREP when the primary cancer site is unknown.

Table 1 to Paragraph (a)

Primary cancers (ICD-10-CM codes) for which probability of causation is to be calculated, if only a secondary cancer site is known. “M” indicates cancer site should be used for males only, and “F” indicates the cancer site should be used for females only.

Secondary cancer (ICD-10-CM code) ICD-10-CM code of likely primary cancers
Lymph nodes of head, face and neck (C77.0) C01, C02, C07(M), C08(M), C09(M), C10(M), C14(F), C32(M), C33, C34, C43, C44, C50(F), C73(F), D03.
Intrathoracic lymph nodes (C77.1) C15(M), C33, C34, C50(F).
Intra-abdominal lymph nodes (C77.2) C15(M), C16(M), C18, C25(F), C33, C34, C50(F), C53(F), C61(M), C64, C65, C66, C68, C82(F), C84(F) (excluding C84.6, C84.7), C85(F), C86(F) (excluding C86.5, C86.6), C91.4(F), C96(F).
Lymph nodes of axilla and upper limb (C77.3) C33, C34, C43, C50(F) , D03.
Inguinal and lower limb lymph nodes (C77.4) C19(M), C20(M), C21(M), C33, C34, C43, C44(F), C60(M), C63(M), D03.
Intrapelvic lymph nodes (C77.5) C18(M), C19(F), C20(F), C21(F), C33(M), C34(M), C53(F), C54(F), C61(M), C67.
Lymph nodes of multiple sites (C77.8) C15(M), C16(M), C18(M), C33, C34, C50(F).
Lymph nodes, site unspecified (C77.9) C15(M), C16, C18, C33, C34, C43, C50(F), C61(M), D03.
Lung (C78.0) C18, C33, C34, C43(M), C50(F), C61(M), C67(M), C64, C65, C66, C68, D03(M).
Mediastinum (C78.1) C15(M), C33, C34, C50(F).
Pleura (C78.2) C15(M), C18(M), C33, C34, C50(F), C56(F), C57(F), C61(M), C64(M), C65(M), C66(M), C68(M).
Other respiratory organs (C78.3) C15, C18(M), C32, C33, C34, C44(M), C50(F), C61(M), C73(F).
Small intestine, including duodenum (C78.4) C17, C18, C25, C33, C34, C49, C43(M), C50(F), C56(F), C57(F), C64(M), C65(M), C66(M), C68(M), D03(M).
Large intestine and rectum (C78.5) C18, C19, C20, C21, C33, C34, C50(F), C56(F), C57(F), C61(M).
Retroperitoneum and peritoneum (C78.6) C16, C18, C19(M), C20(M), C21(M), C25, C33(M), C34(M), C49, C50(F), C54(F), C56(F), C57(F).
Liver, specified as secondary (C78.7) C16(M), C18, C19(M), C20(M), C21(M), C25, C33, C34, C50(F).
Other digestive organs (C78.8) C15(M), C16, C18, C25, C33, C34, C50(F), C61(M).
Kidney (C79.0) C18, C33, C34, C50(F), C53(F), C61(M), C67, C64, C65, C66, C68, C82(F), C84(F) (excluding C84.6, C84.7), C85(F), C86(F) (excluding C86.5, C86.6), C91.4(F), C96(F).
Other urinary organs (C79.1) C18, C50(F), C53(F), C56(F), C57(F), C61(M), C67, C64(F), C65(F), C66(F), C68(F).
Skin (C79.2) C18, C33, C34, C49(M), C43, C44(M), C50(F), C64(M), C65(M), C66(M), C68(M), D03.
Brain and spinal cord (C79.3) C33, C34, C43(M), C50(F), D03(M).
Other parts of nervous system (C79.4) C33, C34, C43(M), C50(F), C61(M), C82, C84 (excluding C84.6, C84.7), C85, C86 (excluding C86.5, C86.6), C91.4, C96, D03(M).
Bone and bone marrow (C79.5) C33, C34, C50(F), C61(M).
Ovary (C79.6) C18(F), C50(F), C56(F), C57(F).
Adrenal gland (C79.7) C18(F), C33, C34, C50(F).
Other specified sites (C79.8) C18, C33, C34, C43(M), C50(F), C56(F), C57(F), C61(M), C67(M), D03(M).
Unspecified sites (C79.9) C18, C33, C34, C43(M), C50(F), C56(F), C57(F), C61(M), C67(M), D03(M).
Carcinoid tumor of distant lymph nodes (C7B.01) C15(M), C16, C18, C33, C34, C43, C50(F),C61(M), D03.
Carcinoid tumor of liver (C7B.02) C16(M), C18, C19(M), C20(M), C21(M), C25, C33, C34, C50(F).
Carcinoid tumor of bone (C7B.03) C33, C34, C50(F), C61(M).
Carcinoid tumor of peritoneum (C7B.04) C16, C18, C19(M), C20(M), C21(M), C25, C33(M), C34(M), C49, C50(F), C54(F), C56(F), C57(F).
Merkel cell carcinoma (C7B.1) C18, C33, C34, C49(M), C43, C44(M), C50(F), C64(M), C65(M), C66(M), C68(M), D03.

(b) DOL will select the site producing the highest estimate for probability of causation to adjudicate the claim.

[67 FR 22309, May 2, 2002, as amended at 84 FR 37590, Aug. 1, 2019]

§ 81.24 Guidelines for leukemia.

(a) For claims involving leukemia, DOL will calculate one or more probability of causation estimates from up to three of the four alternate leukemia risk models included in NIOSH-IREP, as specified in the NIOSH-IREP Operating Guide. These include: “Leukemia, all types” (ICD-10-CM codes C91-C95), “acute lymphocytic leukemia” (ICD-10-CM code C91.0), and “acute myelogenous leukemia” (ICD-10-CM codes C92.6 and C92.A).

(b) For leukemia claims in which DOL calculates multiple probability of causation estimates, as specified in the NIOSH-IREP Operating Guide, the probability of causation estimate DOL assigns to the claim will be based on the leukemia risk model producing the highest estimate for probability of causation.

[67 FR 22309, May 2, 2002, as amended at 84 FR 37591, Aug. 1, 2019]

§ 81.25 Guidelines for claims including two or more primary cancers.

For claims including two or more primary cancers, DOL will use NIOSH-IREP to calculate the estimated probability of causation for each cancer individually. Then DOL will perform the following calculation using the probability of causation estimates produced by NIOSH-IREP:

Equation 1

Calculate: 1−[{1−PC1} × {1−PC2} × . . . × {1−PCn}] = PCtotal,

where PC1 is the probability of causation for one of the primary cancers identified in the claim, PC2 is the probability of causation for a second primary cancer identified in the claim, and PCn is the probability of causation for the nth primary cancer identified in the claim. PCtotal is the probability that at least one of the primary cancers (cancers 1 through “n”) was caused by the radiation dose estimated for the claim when Equation 1 is evaluated based on the joint distribution of PC1, . . ., PCn.3 DOL will use the probability of causation value calculated for PCtotal to adjudicate the claim.

[67 FR 22309, May 2, 2002; 67 FR 62096, Oct. 3, 2002; 84 FR 37591, Aug. 1, 2019]

Footnotes - 81.25

[3] Evaluating Equation 1 based on the individual upper 99th percentiles of PC1, . . ., PCn approximates the upper 99th percentile of PCtotal whenever PC1, . . ., PCn are highly related, e.g., when a common dose-reconstruction is the only non-negligible source of uncertainty in the individual PCi's. However, this approximation can overestimate it if other sources of uncertainty contribute independently to the PC1, . . ., PCn, whereas treating the joint distribution as fully independent could substantially underestimate the upper 99th percentile of PCtotal whenever the individual PCi's are positively correlated.

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