42 C.F.R. Subpart E—Guidelines To Estimate Probability of Causation
Title 42 - Public Health
(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. (a) DOL will calculate probability of causation for all cancers, except chronic lymphocytic leukemia as provided under §81.30, using NIOSH-IREP. (b) Carcinoma in situ (ICD–9 codes 230–234), neoplasms of uncertain behavior (ICD–9 codes 235–238), and neoplasms of unspecified nature (ICD–9 code 239) are assumed to be malignant, for purposes of estimating probability of causation. (c) All secondary and unspecified cancers of the lymph node (ICD–9 code 196) 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 provides guidance for assigning a primary site and calculating probability of causation using 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. (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, below, indicates the primary cancer site(s) DOL will use in NIOSH-IREP when the primary cancer site is unknown. Table 1 Primary cancers (ICD–9 codes3 3 The International Classification of Diseases Clinical Modification (9th Revision) Volume I&II. [1991] Department of Health and Human Services Publication No. (PHS) 91–1260, U.S. Government Printing Office, Washington D.C. (b) DOL will select the site producing the highest estimate for probability of causation to adjudicate the claim. (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 except CLL” (IDC–9 codes: 204–208, except 204.1), “acute lymphocytic leukemia” (ICD–9 code: 204.0), and “acute myelogenous leukemia” (ICD–9 code: 205.0). (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. 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.4 DOL will use the probability of causation value calculated for PCtotal to adjudicate the claim. 4 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. [67 FR 22309, May 2, 2002; 67 FR 62096, Oct. 3, 2002] The following cancers are considered non-radiogenic for the purposes of EEOICPA and this part. DOL will assign a probability of causation of zero to the following cancers: (a) Chronic lymphocytic leukemia (ICD–9 code: 204.1) (b) [Reserved]
Title 42: Public Health
PART 81—GUIDELINES FOR DETERMINING PROBABILITY OF CAUSATION UNDER THE ENERGY EMPLOYEES OCCUPATIONAL ILLNESS COMPENSATION PROGRAM ACT OF 2000
Subpart E—Guidelines To Estimate Probability of Causation
§ 81.20 Required use of NIOSH-IREP.
§ 81.21 Cancers requiring the use of NIOSH-IREP.
§ 81.22 General guidelines for use of NIOSH-IREP.
§ 81.23 Guidelines for cancers for which primary site is unknown.
------------------------------------------------------------------------Secondary cancer (ICD-9 code) ICD-9 code of likely primary cancers------------------------------------------------------------------------Lymph nodes of head, face and 141, 142 (M), 146 (M), 149 (F), 161 (M), neck (196.0). 162, 172, 173, 174 (F), 193 (F).Intrathoracic lymph nodes 150 (M), 162, 174 (F). (196.1).Intra-abdominal lymph nodes 150 (M), 151 (M), 153, 157 (F), 162, 174 (196.2). (F), 180 (F), 185 (M), 189, 202 (F).Lymph nodes of axilla and 162, 172, 174 (F). upper limb (196.3).Inguinal and lower limb lymph 154 (M), 162, 172, 173 (F), 187 (M). nodes (196.5).Intrapelvic lymph nodes 153 (M), 154 (F), 162 (M), 180 (F), 182 (196.6). (F), 185 (M), 188.Lymph nodes of multiple sites 150 (M), 151 (M), 153 (M), 162, 174 (F). (196.8).Lymph nodes, site unspecified 150 (M), 151, 153, 162, 172, 174 (F), 185 (196.9). (M).Lung (197.0)................. 153, 162, 172 (M), 174 (F), 185 (M), 188 (M), 189.Mediastinum (197.1).......... 150 (M), 162, 174 (F).Pleura (197.2)............... 150 (M), 153 (M), 162, 174 (F), 183 (F), 185 (M), 189 (M).Other respiratory organs 150, 153 (M), 161, 162, 173 (M), 174 (F), (197.3). 185 (M), 193 (F).Small intestine, including 152, 153, 157, 162, 171, 172 (M), 174 duodenum (197.4). (F), 183 (F), 189 (M).Large intestine and rectum 153, 154, 162, 174 (F), 183 (F), 185 (M). (197.5).Retroperitoneum and 151, 153, 154 (M), 157, 162 (M), 171, 174 peritoneum (197.6). (F), 182 (F), 183 (F).Liver, specified as secondary 151 (M), 153, 154 (M), 157, 162, 174 (F). (197.7).Other digestive organs 150 (M), 151, 153, 157, 162, 174 (F), 185 (197.8). (M).Kidney (198.0)............... 153, 162, 174 (F), 180 (F), 185 (M), 188, 189, 202 (F).Other urinary organs (198.1). 153, 174 (F), 180 (F), 183 (F), 185 (M), 188, 189 (F).Skin (198.2)................. 153, 162, 171 (M), 172, 173 (M), 174 (F), 189 (M).Brain and spinal cord (198.3) 162, 172 (M), 174 (F).Other parts of nervous system 162, 172 (M), 174 (F), 185 (M), 202. (198.4).Bone and bone marrow (198.5). 162, 174 (F), 185 (M).Ovary (198.6)................ 153 (F), 174 (F), 183 (F).Suprarenal gland (198.7)..... 153 (F), 162, 174 (F).Other specified sites (198.8) 153, 162, 172 (M), 174 (F), 183 (F), 185 (M), 188 (M).------------------------------------------------------------------------
§ 81.24 Guidelines for leukemia.
§ 81.25 Guidelines for claims including two or more primary cancers.
§ 81.30 Non-radiogenic cancers.
Appendix A to Part 81—Glossary of ICD–9 Codes and Their Cancer Descriptions1
------------------------------------------------------------------------ ICD-9 code Cancer description------------------------------------------------------------------------140....................................... Malignant neoplasm of lip.141....................................... Malignant neoplasm of tongue.142....................................... Malignant neoplasm of major salivary glands.143....................................... Malignant neoplasm of gum.144....................................... Malignant neoplasm of floor of mouth.145....................................... Malignant neoplasm of other and unspecified parts of mouth.146....................................... Malignant neoplasm of oropharynx.147....................................... Malignant neoplasm of nasopharynx.148....................................... Malignant neoplasm of hypopharynx.149....................................... Malignant neoplasm of other and ill-defined sites within the lip, oral cavity, and pharynx.150....................................... Malignant neoplasm of esophagus.151....................................... Malignant neoplasm of stomach.152....................................... Malignant neoplasm of small intestine, including duodenum.153....................................... Malignant neoplasm of colon.154....................................... Malignant neoplasm of rectum, rectosigmoid junction, and anus.155....................................... Malignant neoplasm of liver and intrahepatic bile ducts.156....................................... Malignant neoplasm of gall bladder and extrahepatic bile ducts.157....................................... Malignant neoplasm of pancreas.158....................................... Malignant neoplasm of retroperitoneum and peritoneum.159....................................... Malignant neoplasm of other and ill-defined sites within the digestive organs and peritoneum.160....................................... Malignant neoplasm of nasal cavities, middle ear, and accessory sinuses.161....................................... Malignant neoplasm of larynx.162....................................... Malignant neoplasm of trachea, bronchus and lung.163....................................... Malignant neoplasm of pleura.164....................................... Malignant neoplasm of thymus, heart, and mediastinum.165....................................... Malignant neoplasm of other and ill-defined sites within the respiratory system and intrathoracic organs.170....................................... Malignant neoplasm of bone and articular cartilage.171....................................... Malignant neoplasm of connective and other soft tissue.172....................................... Malignant melanoma of skin.173....................................... Other malignant neoplasms of skin.174....................................... Malignant neoplasm of female breast.175....................................... Malignant neoplasm of male breast.179....................................... Malignant neoplasm of uterus, part unspecified.180....................................... Malignant neoplasm of cervix uteri.181....................................... Malignant neoplasm of placenta.182....................................... Malignant neoplasm of body of uterus.183....................................... Malignant neoplasm of ovary and other uterine adnexa.184....................................... Malignant neoplasm of other and unspecified female genital organs.185....................................... Malignant neoplasm of prostate.186....................................... Malignant neoplasm of testis.187....................................... Malignant neoplasm of penis and other male genital organs.188....................................... Malignant neoplasm of urinary bladder.189....................................... Malignant neoplasm of kidney and other unspecified urinary organs.190....................................... Malignant neoplasm of eye.191....................................... Malignant neoplasm of brain.192....................................... Malignant neoplasm of other and unspecified parts of nervous system.193....................................... Malignant neoplasm of thyroid gland.194....................................... Malignant neoplasm of other endocrine glands and related structures.195....................................... Malignant neoplasm of other and ill-defined sites.196....................................... Secondary and unspecified malignant neoplasm of the lymph nodes.197....................................... Secondary malignant neoplasm of the respiratory and digestive organs.198....................................... Secondary malignant neoplasm of other tissue and organs.199....................................... Malignant neoplasm without specification of site.200....................................... Lymphosarcoma and reticulosarcoma.201....................................... Hodgkin's disease.202....................................... Other malignant neoplasms of lymphoid and histiocytic tissue.203....................................... Multiple myeloma and other immunoproliferative neoplasms.204....................................... Lymphoid leukemia205....................................... Myeloid leukemia.206....................................... Monocytic leukemia.207....................................... Other specified leukemia.208....................................... Leukemia of unspecified cell type.------------------------------------------------------------------------\1\ The International Classification of Diseases Clinical Modification (9th Revision) Volume I&II. [1991] Department of Health and Human Services Publication No. (PHS) 91-1260, U.S. Government Printing Office, Washington, D.C.
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