Chapter 2-0900 Development of Radiogenic Cancer Claims

TABLE OF CONTENTS

Paragraph and Subject Date Trans. No.

Chapter 2-0900 Development of Radiogenic Cancer Claims

Table of Contents . . . . . . . 03/16 16-06

1 Purpose and Scope . . . . . . . 03/16 16-06

2 Identifying a Claim for

Cancer. . . . . . . . . . . . 03/16 16-06

3 Medical Evidence of Cancer. . . 03/16 16-06

4 Pre-Cancerous and Non-Malignant

Conditions. . . . . . . . 03/16 16-06

5 Specified Cancers . . . . . . . 03/16 16-06

6 Non-SEC Cancers and Dose 03/16 16-06

Reconstruction. . . . . . . . 03/16 16-06

7 Preparing Non-SEC Cancer Claim

Files for Referral to NIOSH . 03/16 16-06

8 Preparing Amendments to the

NRSD for Non-SEC Cancer

Claims. . . . . . . . . . . . 03/16 16-06

9 Cases Pulled While at NIOSH . . 03/16 16-06

10 NIOSH Actions . . . . . . . . . 03/16 16-06

11 Receipt of Dose Reconstruction

Results from NIOSH. . . . . . 03/16 16-06

12 Review of Claim for Rework

of Dose Reconstruction. . . . 03/16 16-06

13 Procedures for Requesting

Rework. . . . . . . . . . . . 03/16 16-06

14 Comments to Dose Reconstruction

Submitted to FAB. . . . . . . 03/16 16-06

15 Proving Causation Between

Diagnosed Non-SEC Cancer and

Covered Employment. . . . . . 03/16 16-06

16 Calculation of PoC Using

NIOSH-IREP Computer Program . 03/16 16-06

17 Establishing Causation for

Cancer under Part E . . . . . 03/16 16-06

Exhibits

1 NIOSH Referral Summary

Document (NRSD) . . . . . . . 03/16 16-06

2 Instructions for Completing

the NRSD. . . . . . . . . . . 03/16 16-06

3 NIOSH Referral Letter to

Claimant. . . . . . . . . . . 03/16 16-06

4 Examples of Rework Request. . . 03/16 16-06

5 Review of Dose Reconstruction

Letter to Claimant. . . . . . 03/16 16-06

6 Primary Cancer Sites. . . . . . 03/16 16-06

7 Glossary of Cancer Descriptions 03/16 16-06

1. Purpose and Scope. This chapter includes a narrative discussion of the procedures for determining whether an employee has been diagnosed with a cancer and the procedures for establishing causation as a result of exposure to occupational radiation.

2. Identifying a Claim for Cancer. The Claims Examiner (CE) must first identify whether the claim is being made for cancer. If Form EE-1 or Form EE-2 is marked for a cancer, then a cancer claim is established. The claimant is asked to identify the specific type of diagnosed cancer on the claim form.

3. Medical Evidence of Cancer. Energy Employees Occupational Illness Compensation Program Act (EEOICPA) regulations state that to establish a diagnosis of cancer, a claimant must submit medical evidence that sets forth the diagnosis and the date of the diagnosis. The CE verifies that sufficient medical evidence is in the case file that substantiates a diagnosis of cancer.

a. Diagnosis of Cancer. The case record must include a medical report from a qualified physician that lists a cancer diagnosis. The CE can make referrals to a Contract Medical Consultant (CMC) to assist in interpreting medical evidence as establishing a diagnosis of cancer. Whether the evidence originates from a claimant’s physician or a CMC, a diagnosis generally derives from the following evidence:

(1) Tissue examination is the most conclusive method for making a cancer diagnosis, as it provides the physician with the vital information listed below regarding the tumor or lesion. A testing facility reports the outcome of human tissue analysis in a pathology report. The pathology report follows from a biopsy undertaken by a physician during routine screening or post mortem (autopsy). The pathology report identifies particular data that are critical for making a cancer diagnosis.

(a) The tissue of origin (where the tumor or lesion originated); and

(b) The status of the tested cellular tissue as benign, uncertain, or malignant. This chapter of the Federal (EEOICPA) Procedure Manual only addresses processing malignant (cancerous) tumors/lesions.

(2) A diagnosis can sometimes be made using one or more of the following methods, which are listed in order of preference. If the CE is unable to identify an affirmative diagnosis based on the medical evidence submitted, the case may be referred to a CMC.

(a) Cytology report describing cells obtained by scraping (e.g., from bone marrow), or by washing (e.g., fluid from lungs). An examination conducted by one of these cytology methods is generally less conclusive than tissue examination because the organization and extent of the tumor may not be as apparent. A positive cytology report would be a basis for further tests.

(b) Imaging (e.g., X-ray, CAT Scan, MRI) are the least specific type of tests in the diagnosis of cancer. Generally, X-rays are used as a basis for further tests. Radiology tests are extremely beneficial in determining the spread of cancer and/or determining the effects of cancer treatments.

(3) If the employee is deceased or if a living employee is unable to undergo additional diagnostic testing for medical reasons, clinical evidence is needed which shows that a qualified physician has evaluated available medical evidence and has provided a well-rationalized opinion that interprets such evidence as establishing a diagnosis of cancer. Documentation that a physician can use for such a purpose includes hospital admission/discharge reports or reports describing a tumor or possible malignancy; inconclusive diagnostic testing results, or other medical records alluding to the existence of a potential cancer.

(a) In the absence of other affirmative medical evidence collected during development, a CE may use a death certificate acknowledged by a physician or recognized by a state medical authority to establish a cancer diagnosis.

b. Diagnosis of Multiple Primary Cancers.

(1) If a CE identifies more than one primary cancer in the medical evidence in the same organ with the same diagnosis date and a physician has classified each as the same type of cancer, the CE considers all as one primary cancer.

For example, a surgeon performs two biopsies of the left breast on the same date. Several days afterwards, a pathologist interprets the samples as showing infiltrating ductal carcinomas. In this case, the CE considers the results as diagnosing one primary cancer of the left breast.

Alternatively, if the pathologist interpreted the same biopsies as documenting a lobular carcinoma and an infiltrating ductal carcinoma, the CE considers these cancers as two primary cancers, since the cancer types are different.

The CE can only resolve issues relating to the number of primary cancers diagnosed from pathology or clinical evidence by obtaining the opinion of a qualified physician. In the absence of a well-rationalized opinion from a claimant’s treating physician, a CE refers such matters to a CMC for review.

(2) The above guidance applies only to multiple primary cancers of the same type in an organ. Situations involving bilateral organs are more complicated. Bilateral organs include the lungs, breasts, kidneys, adrenals, ovaries, and testes.

Biopsies taken from the left and right lungs might indicate the same type of cancer, e.g., non-small cell adenocarcinoma, in the right and left lungs. While one cancer may actually be metastatic from the other lung, without any indication in the pathology report or other medical evidence, it would be difficult to determine whether these two adenocarcinomas are two primary cancers or just one cancer. In these situations, the CE requests clarification from either the treating physician or a CMC.

c. Date of Diagnosis. The date of initial diagnosis is required in any claim for cancer. The date of diagnosis is also a critical element used in the Interactive Radio-Epidemiological Program (IREP) for calculating the Probability of Causation (PoC). The employee’s occupational exposure to radiation must be before the initial date of diagnosis for it to be compensable under Part B. While a claimant may list the date of diagnosis on Form EE-1 or Form EE-2, the CE reviews all of the medical evidence submitted in a claim package to determine the earliest date of cancer diagnosis.

(1) When using a pathology report to determine the date of diagnosis, the date that a physician biopsied the tissue is used as the date of diagnosis.

(2) In certain claim situations, the CE will have to use reasonable discretion to decide the date of diagnosis. For example, if the employee is deceased, and the only documentation available to support the diagnosis of cancer is the employee’s death certificate signed by a physician, the CE may accept an affidavit from a survivor(s) and/or other individuals to establish that the employee’s diagnosis date is subsequent to the employee’s initial exposure to occupational radiation.

For example, a home health nurse might indicate in an affidavit his or her knowledge that on a specified date, a physician made a diagnosis of the employee’s condition, as well as the circumstances under which he or she acquired such knowledge.

d. Deficiency in Medical Evidence. The CE advises the claimant of any deficiency in medical evidence and allows the claimant a period of up to 60 days to submit additional medical evidence. All development communication from the CE must be clear and include understandable guidance of what evidence is required to support the claim.

4. Pre-Cancerous and Non-Malignant Conditions. If the medical evidence provided by the claimant establishes a diagnosis of a condition in a pre-cancerous stage or is non-malignant, the CE cannot accept the condition as a cancer. However, the CE proceeds with development of the condition for coverage under Part E. The receipt of a qualified physician’s opinion can only resolve the interpretation of whether a condition is a diagnosed cancer or not. If the CE cannot obtain clarification of such issues from the claimant’s chosen physician, he or she can refer the medical evidence to a CMC.

5. Specified Cancers. Members of the Special Exposure Cohort (SEC) who are diagnosed with any of the 22 specified cancers are eligible for benefits without the need for a dose reconstruction. Eligible members of a SEC class have a presumption that the diagnosed specified cancer was caused by radiation exposure during their eligible SEC employment.

6. Non-SEC Cancers and Dose Reconstruction. Any primary cancer that is not a specified cancer is a non-SEC cancer. Once the CE has determined that the employee has a diagnosed non-SEC cancer and covered employment, he or she prepares the claim for referral to the National Institute for Occupational Safety and Health (NIOSH) for a dose reconstruction. The CE is to report a secondary cancer only when the development of the claim has not resulted in the identification of the primary cancer.

a. Claimant Not SEC Member. When the employee is not a SEC member (i.e., the employment was outside the designated SEC period or the employee did not work the necessary workdays at an SEC site), the CE forwards the claim to NIOSH for dose reconstruction, once a cancer diagnosis and covered employment are confirmed.

b. SEC Case with Award. For any SEC cases where an award has been made for a specified cancer, any non-SEC cancers for the case must be forwarded to NIOSH for dose reconstruction to determine eligibility for medical benefits for the non-SEC primary cancers. In these SEC cases, all cancers are listed on the NIOSH Referral Summary Document (NRSD), including the specified cancer(s).

(1) An exception to this rule includes those SEC claims where a primary cancer, which is not a specified cancer, metastasizes to a secondary cancer site that a CE has decided is a specified cancer. For instance, prostate cancer (non-specified cancer) metastasizes to secondary bone cancer (specified cancer). If the bone cancer is accepted as a specified cancer under the SEC provision, the claimant can receive medical benefits for both primary and secondary cancers (prostate and bone cancer). However, according to EEOICPA regulations, payment for medical treatment of the underlying primary cancer…does not constitute a determination by OWCP that the primary cancer is a covered illness. As such, it will be necessary for the CE to refer the prostate cancer to NIOSH for dose reconstruction to determine eligibility for benefits under Part E for prostate cancer. In this situation, since the bone cancer is a secondary cancer with known primary site (prostate), it is not included on the NIOSH NRSD.

c. Multiple Skin Cancers. When a claimant provides evidence that the covered employee has a large number of skin cancers, the CE will proceed as follows:

(1) The CE considers each malignant skin neoplasm (e.g., basal or squamous cell cancer) as a separate primary cancer, unless the medical records state that the neoplasm is a metastatic lesion.

(2) For NIOSH dose calculations, the date of diagnosis and the location (e.g., arm, neck, back) of the skin cancer are important. The CE must include this information in the medical section of the NRSD.

d. Multiple Primary Cancers for Other Organs/Locations. If a CE identifies more than one primary cancer location for an organ in the medical records (e.g., multiple sites of primary cancer in the lung), the CE notes this information in the medical section of the NRSD, including the cancer locations within the organ and the diagnosis date. NIOSH will perform dose calculations for each primary cancer site in a specific organ. When NIOSH reports the dose reconstruction results, the CE calculates the PoC values for each of the primary cancers in that organ.

7. Preparing Non-SEC Cancer Claim Files for Referral to NIOSH. The NRSD (Exhibit 1) is a tabular form containing the medical and employment information accepted by the CE as factual. This form provides NIOSH with the necessary information to proceed with the dose reconstruction process.

a. Instructions. Step-by-step instructions for completing the NRSD are included in Exhibit 2.

b. Smoking History. The employee’s smoking history is required for cases that include primary lung cancer (including primary trachea, bronchus, and lung) or for secondary cancer with an unknown primary cancer that includes lung cancer as a possible primary cancer.

(1) The method used to gather smoking history is Form EE/EN-8.

(2) Upon receipt of the information from the claimant, indicate the smoking level (at the time of cancer diagnosis) using the designations shown in the NRSD. If the case evidence contradicts information obtained on the questionnaire, the CE must clarify the discrepancy with the claimant prior to referral to NIOSH.

(3) If the claimant does not return the initial smoking questionnaire within 30 days, the CE sends a follow-up letter advising the claimant that they are to return the questionnaire within the next 30 days or their case will be closed administratively. After a total of 60 days has elapsed, the CE administratively closes the claim and informs the claimant by letter that the claim is closed and no further action will be taken relating to the claimed illness(es) under Part B. The CE proceeds with any necessary development relating to a Part E claim.

(a) If the CE can obtain the relevant information from the employee’s medical records or Document Acquisition Request (DAR), the CE uses that information to complete the NRSD. The CE includes a memo to file explaining the source of the information.

c. Ethnicity. Employee’s ethnicity is required for skin cancer cases.

(1) The method used to gather this information is Form EE/EN-9.

(2) Upon receipt of the information from the claimant, indicate the ethnicity using the designations shown in the NRSD.

(3) If the claimant does not return the initial ethnicity questionnaire within 30 days, the CE follows the same steps required for collecting information relating to the employee’s smoking history (i.e., second request, administrative closure and notice). Like the guidance for obtaining an employee’s smoking history, if the CE can obtain the relevant ethnicity information from the employee’s medical records or Document Acquisition Request (DAR), the CE uses that information to complete the NRSD. The CE includes a memo to file explaining the source of the information.

d. Case Referred to NIOSH.

(1) All findings made by the CE must be supported by the evidence in file and documented in the NRSD. The CE forwards a copy of the entire case file with the NRSD to NIOSH.

(2) The CE advises the claimant in writing that he or she has sent the case to NIOSH for dose reconstruction (Exhibit 3).

8. Preparing Amendments to the NRSD for Non-SEC Cancer Claims. Sometimes CEs obtain additional information on a case after they refer it to NIOSH but before the completion of the dose reconstruction. This includes new information related to the employee’s employment, new medical condition(s), new authorized representative, or other survivor-related information. The CE is to bronze into OIS all documentation created or received for a case file.

When new information becomes available, the CE forwards this information to NIOSH so it is available for dose reconstruction. The CE identifies the portion of the NRSD that has changed based on new evidence reviewed by the District Office (DO). He or she also marks “Amendment” on the top of the NRSD and lists the employee's name, DOL case ID number, NIOSH tracking number, and DOL Information. The CE describes clearly and separates any “Amendment” NRSDs from NRSDs submitted with the DO’s weekly package to NIOSH. A CE or other designated staff person ensures that any supplemental packages are separated from regular NRSDs for clear identification by NIOSH.

a. NIOSH Reports. NIOSH provides weekly reports to the DOs listing the cases for which the NIOSH contractor started performing dose calculations in the past week. For any revisions to information contained in the original NRSD, the CE is to forward to NIOSH an amended NRSD clearly identifying the revised information. This will allow NIOSH to use the most accurate information in its dose reconstruction.

b. “Supplement” NRSD. If the CE needs to submit additional evidence to NIOSH, such as additional medical information for the same reported cancer, the CE submits a NRSD marked “Supplement.” The CE lists on the referral the DOL case ID number, NIOSH tracking number, and employee’s name. A CE uses a supplemental NRSD only for a submission that does not change the original information in the NRSD.

9. Cases Pulled While at NIOSH. During the dose reconstruction process, it may be necessary for NIOSH to contact the CE to resolve a discrepancy, or request clarification. Normally, this contact is via e-mail or telephone. The CE handles all contacts from NIOSH as quickly as possible. If the CE cannot provide an answer to a question without further development, the CE advises NIOSH of the steps being taken to resolve the matter and an approximate period for completion.

In cases where further development is needed as determined by NIOSH or DOL, NIOSH pulls the case from the dose reconstruction process and advises the CE by e-mail. NIOSH may also pull a case to allow DOL to determine if a case can be accepted under a SEC class. Since a pulled case stops the dose reconstruction process, the CE must proactively develop the case so the dose reconstruction process can proceed or a decision can be rendered on a SEC case.

a. Cases Pulled by DOL. When DOL determines that further development is needed before a dose reconstruction can proceed, the supervisor, SrCE (or journey level CE), or DO NIOSH liaison sends an e-mail (with copies to the other two DO staff) to the NIOSH Public Health Advisor (PHA) with a request that NIOSH pull the case while DOL develops the case for additional information. The CE must advise the claimant in writing when a case is pulled by DOL from the dose reconstruction process.

(1) The e-mail briefly explains the specific information the DO is attempting to clarify or obtain, e.g., employment, medical, smoking or race/ethnicity questionnaire, etc.

(2) On receipt of the development information, the designated DOL staff person notifies the NIOSH PHA (with copies to the other two DO staff) by e-mail of the resolution of the issue and requests that the case be removed from pulled status. The DO also prepares and forwards, as necessary, an amended NRSD containing the new information. The CE advises the claimant in writing that their case has been removed from pulled status and that the dose reconstruction is proceeding.

b. Cases Pulled Due to SEC. NIOSH may identify cases submitted for dose reconstruction that are potentially eligible for inclusion in a SEC class. This may typically occur when a new SEC class is designated. NIOSH pulls these cases from the dose reconstruction process and returns these cases with the dose reconstruction records to the appropriate district office for further development. The CE handling the case ensures that any record received from NIOSH as part of the dose reconstruction process is bronzed into OIS or maintained by the district office as a permanent record of the case file. NIOSH will send the claimant a letter advising the claimant that it is returning the claim to DOL for adjudication.

If DOL identifies a case that qualifies under the SEC provision but NIOSH did not pull it from the dose reconstruction process, the CE, through the SrCE or journey level CE, notifies the appropriate NIOSH PHA via e‑mail to return the dose reconstruction records for further development. In these cases, the CE sends a letter to the claimant advising that his or her case is pulled from the dose reconstruction process for evaluation under the SEC provision.

If it is determined that the case does not qualify for the SEC class, the CE, through the SrCE or journey level CE, notifies the appropriate NIOSH PHA via e-mail to proceed with the dose reconstruction. The CE prints a copy of the “sent” e-mail and bronzes it into OIS. The e-mail includes a brief statement explaining why the case should proceed with dose reconstruction, e.g., non-specified cancer, insufficient latency period or does not meet the 250 workday requirement. In addition, the CE notifies the claimant by letter that the case is returned to NIOSH for dose reconstruction and the reason(s) it does not qualify for the SEC class. The CE also sends a copy of this letter to NIOSH.

10. NIOSH Actions. Upon receipt of a claims package from DOL, NIOSH takes several actions to determine the employee’s radiation dose. NIOSH will request Department of Energy (DOE) records and interview the claimant(s) to identify any additional relevant information on employment history and develop detailed information on work tasks and radiological exposures. NIOSH will also apply dose reconstruction methods to estimate radiation doses for workers seeking compensation for cancer who were not monitored or inadequately monitored, or whose records are missing or incomplete for exposure to radiation at a DOE or Atomic Weapons Employer (AWE) facility. NIOSH will then conduct a closing interview with the claimant(s) to review the dose reconstruction results and the basis upon which the results were calculated.

a. Obtain Signature on Form OCAS-1. Subject to any additional information provided by the claimant, the claimant is required to sign and return Form OCAS-1 to NIOSH within 60 days, certifying that he or she has no additional information and that the record for dose reconstruction should be closed.

Upon receipt of the signed Form OCAS-1 and completion of any changes in the dose reconstruction resulting from new information provided, NIOSH forwards a final dose reconstruction report, “NIOSH Report of Dose Reconstruction under EEOICPA”, to DOL and to the claimant.

(1) NIOSH does not forward the dose reconstruction report to DOL for adjudication without receipt of Form OCAS-1 signed by the claimant or an authorized representative of the claimant.

(a) If the claimant or the authorized representative does not sign and return Form OCAS-1 within 60 days, NIOSH will administratively close the dose reconstruction and notify DOL of this action after notifying the claimant or the authorized representative.

(b) Upon receiving this notification by NIOSH, the CE records in the Energy Compensation System (ECS) the administrative closure of the affected Part B claim based on the lack of a signed Form OCAS-1.

(c) If the employee meets the Part E employment requirements (contractor or subcontractor), prior to administrative closure, the CE determines if a causal link exists between the claimed illness and exposure to toxic substances (other than radiation) at a DOE facility or certain RECA facility. When a causal link is determined, the CE is able to accept the cancer under Part E. If no non-radiogenic toxic substance causal link is established, the CE administratively closes the case in ECS under Part E.

(d) The CE advises the claimant by letter that the case is closed. If the claimant later decides to sign the Form OCAS-1, he or she needs to notify DOL, after which the CE returns the case to NIOSH for processing.

(e) If additional information is submitted, NIOSH will review the evidence, prepare a new dose reconstruction report, and send a new Form OCAS-1 to the claimant and allow for an additional 60-day comment period.

(2) If the case has multiple claimants, NIOSH will wait 60 days for receipt of all signed Forms OCAS-1. If, after 60 days, NIOSH does not receive Form OCAS-1 from any of the claimants, NIOSH will administratively close the dose reconstruction and notify DOL of this action after notifying the claimants or the authorized representatives. The CE also administratively closes the corresponding DEEOIC claim(s) in accordance with paragraph 10a(1). If, after 60 days, NIOSH receives only one signed Form OCAS-1, NIOSH will forward the dose reconstruction package to DOL.

(a) One signed Form OCAS-1 is sufficient to proceed with issuing a decision for all filing claimants.

11. Receipt of Dose Reconstruction Results from NIOSH.

a. Content of NIOSH Report. The "NIOSH Report of Dose Reconstruction under EEOICPA" provides the information that the CE needs to perform a PoC calculation, which is necessary to render a decision on the claim. The NIOSH report includes the following information:

(1) Annual dose estimates related to covered employment for each year from the date of initial radiation exposure at a covered facility to the date of cancer diagnosis;

(2) Separate dose estimates for acute and chronic exposures, different types of ionizing radiation, and internal and external doses, providing dose information for the organ or tissue relevant to the primary cancer site(s) established in the claim;

(3) Uncertainty distributions associated with each dose estimated, as necessary;

(4) Explanation of each type of dose estimate included in terms of its relevance for estimating PoC;

(5) Identification of any information provided by the claimant relevant to dose estimation that NIOSH decided to omit from the basis for dose reconstruction, justification for the decision, and if possible, a quantitative estimate of the effect of the omission on the dose reconstruction results; and

(6) A summary and explanation of information and methods applied to produce the dose reconstruction estimates, including any factual findings and the evidence upon which those findings are based.

b. NIOSH CD or Electronic Record. When NIOSH returns a dose reconstruction to DEEOIC, NIOSH will forward all case file documents via compact disc (CD) or as an electronic record, since NIOSH optically scans all documents referred to it for use in performing the dose reconstruction. The CD or electronic record will include the dose reconstruction input file (Excel spreadsheet) used for calculating the IREP probability of causation. The CE bronzes into OIS or includes as a permanent record of the case file any record received from NIOSH as part of the dose reconstruction process.

(1) Information contained on the NIOSH CD or electronic record will include:

(a) Dose reconstruction files; Computer Assisted Telephone Interview (CATI); dosimetry data; the NIOSH Report of Dose Reconstruction under EEOICPA; NIOSH’s PoC calculation; Form OCAS-1; the NIOSH-IREP input file; and pertinent Atomic Energy Commission (AEC)/DOE reports, journal articles or other documents.

(b) Correspondence, including NIOSH letters to claimants, phone conversation notes, and e-mails.

(c) DOE files (data files listed in order of importance on the CD), including DOE dose and work history information and other DOE documents that NIOSH requested, such as incident reports and special studies.

(d) DOL files, including a copy of the case file optically imaged by NIOSH and the OCAS tracking sheets (signatures and dates).

(2) NIOSH will incorporate information from the above sources into the dose reconstruction report. Publicly available documents will be referenced by citation. NIOSH will add documents not publicly available in the record and, as noted above, will be included on the CD or as part of the electronic record transferred to DEEOIC.

(3) The CE need not review all of the documents on the CD or electronic record. Those documents that normally will not require review include the DOE documents, the claimant interview, and the NIOSH-conducted closing interview. The CE must always run the IREP separately.

c. NIOSH Unable to Perform Dose Reconstruction. In some cases, it may not be possible for NIOSH to complete a dose reconstruction because of insufficient information to reasonably estimate the occupational radiation dose received by the employee. In these situations, NIOSH notifies any claimant for whom it cannot complete a dose reconstruction and it describes the basis for this finding. NIOSH forwards its determination to DOL and the CE issues a RD to deny the claim based on NIOSH’s inability to complete the dose reconstruction.

12. Review of Claim for Rework of Dose Reconstruction. The CE is responsible for comparing the dose reconstruction report to the evidence in the case file. If there are any significant discrepancies or changes between the information in the case file and the dose reconstruction report, including erroneous or incomplete information, or for which DEEOIC has received new information, the CE determines if rework may be necessary.

Significant discrepancies or changes would include, for example, additional cancer identified or changed cancer site, changed employment facilities or dates, different diagnosis code, or change in date of cancer diagnosis.

a. Cancer Change Rework.

(1) If additional cancer(s) is identified after the dose reconstruction is performed and:

(a) PoC is less than 50%, the CE submits a rework request to NIOSH.

(b) PoC is 50% or greater, a rework is not required. All additional primary cancers would be eligible for medical benefits under Part B and Part E. The CE documents the newly identified cancer(s) in the case file.

(2) If two or more primary cancers are addressed in the dose reconstruction, and it is later determined that one or more of the cancers should not have been included in the dose reconstruction (e.g., the cancer was found to be a recurrent cancer or an erroneously reported cancer) and:

(a) PoC is less than 50%, a rework is not required. The PoC for the remaining cancers will still be below 50%. The CE must use the PoC as calculated as the PoC of record; document the discrepancy between the cancer(s) identified in the dose reconstruction and those determined by DOL to be cancers in the case file and in the RD; and notify the NIOSH PHA of the change to the cancer(s) status so that NIOSH can update its records.

(b) If PoC is 50% or greater, submit a rework request to NIOSH. Also, if a primary cancer addressed in the dose reconstruction is found subsequently to be a secondary cancer with an unknown primary, submit a rework request to NIOSH.

DOs cannot substitute newly identified cancers or additional cancers not used in the dose reconstruction, or their diagnosis dates, for incorrectly reported cancers found in the dose reconstruction.

b. Smoking and Race/Ethnicity Changes Rework. If information related to race/ethnicity or smoking history changes after the dose reconstruction is performed, the CE re-runs IREP using the revised information. A rework is not required except for the following:

(1) If the PoC is initially below 45% and then increases above 50% or greater after re-running IREP using the revised information, the CE submits a rework request to the DEEOIC Health Physicist.

(2) If the PoC was above 50% and the change reduces the PoC below that threshold, the CE submits a rework request to the DEEOIC Health Physicist.

c. Diagnosis Code Changes Rework. Changes can affect the internal and/or external dose models used in the dose reconstruction and/or the IREP model. Accordingly, the CE submits a rework request for changes in diagnosis codes to the DEEOIC Health Physicist. If the diagnosis code changes for the following condition, no rework is required:

(1) For carcinoma in situ skin, if the type of cancer is specified by DOL (Malignant melanoma or Non-melanoma skin-Squamous cell), NIOSH will use only the specified IREP model. If the cancer is not specified, NIOSH will run both IREP models and the model which results in the highest PoC will be used.

d. NIOSH-IREP Changes Rework. If the diagnosis code changes, submit a rework request to the DEEOIC Health Physicist.

e. Diagnosis Date Changes Rework. The net effect of a change in the diagnosis date depends mostly on the type of cancer, the worker’s age at the time of diagnosis, and whether or not the year of diagnosis falls within the latency period for development of the cancer (which, in turn, varies by IREP cancer model). Depending on the factors listed above, it is possible for an earlier diagnosis date to result in an increase in the PoC. For changes to the diagnosis date:

(1) When the PoC is less than 40% and,

(a) The diagnosis date is in the same calendar year, a rework is not required.

(b) If the diagnosis date is found to be outside the calendar year (either earlier or later), the CE submits a rework request to NIOSH.

(2) When the PoC is between 40% and 49.99%, and there is any change to the diagnosis date, the CE submits a rework request to the DEEOIC Health Physicist.

(3) When the PoC is 50% or greater,

(a) If the diagnosis date is found to be later, a rework is not required.

(b) If the diagnosis date is found to be earlier, the CE submits a rework request to NIOSH.

(c) The CE documents the difference in the diagnosis date in the case file and ensures that the difference in the diagnosis date used in the dose reconstruction is noted in the RD.

(d) The CE notifies the NIOSH PHA of the change in the diagnosis date so that NIOSH can update its records.

f. Employment Changes Rework.

(1) If the PoC is 50% or greater and the CE identifies additional DOL-verified employment, a rework is not required.

(2) If the PoC is 50% or greater and the DOL-verified employment is found to be less than that used in the dose reconstruction, the CE submits a request for rework to the DEEOIC Health Physicist for review, and includes an electronic copy of the dose reconstruction report.

(3) If the PoC is between 40% and 49.99%, and the CE identifies additional DOL-verified employment, the CE submits a request for rework to the DEEOIC Health Physicist for review, and includes an electronic copy of the dose reconstruction report.

(4) If the PoC is less than 40%, and additional DOL-verified employment is identified:

(a) If all the additional employment falls within the same calendar year and the year is addressed in the dose reconstruction, a rework is not required.

(b) If the additional employment extends into, or is wholly within another calendar year not addressed in the dose reconstruction, the CE submits a rework request to the NIOSH.

(5) Some dose reconstructions contain more employment than originally verified by DOL in the NRSD. NIOSH may have DOE dosimetry or employment records for periods not identified by DOL, or the dose reconstruction may use a continuous period rather than considering numerous breaks in employment.

(a) If the case is likely non-compensable, NIOSH may add the additional time period to the DOL-verified employment for the purpose of completing a dose reconstruction (unless it is military, navy nuclear, or non-DOE federal service) in a timely manner.

(b) If the PoC is less than 50% and the dose reconstruction contains employment added by NIOSH, a rework is not required. However, the CE must write a memo to file that DOL did not verify part of the employment period assumed by NIOSH, but that the employment period was assumed correct for completing the dose reconstruction in a timely manner.

Should new information arise to warrant performing the dose reconstruction again (e.g., additional cancer diagnosis, additional employment at another site), only employment verified by DOL will be used, which may be more restrictive than that allowed in the current dose reconstruction. The CE ensures that he or she includes an explanation of this as part of the narrative analysis included in any forthcoming RD.

If NIOSH has added employment to a claim that is likely compensable, NIOSH contacts the CE with the additional employment information for DOL review and verification. After verification, the CE submits an amended NRSD listing all accepted employment to NIOSH.

(c) If the PoC is 50% or greater and the dose reconstruction contains employment added by NIOSH but not approved by the DO, the CE submits a rework request to the DEEOIC Health Physicist.

(6) If a CE identifies military, navy nuclear, or non-DOE federal service employment referenced in the dose reconstruction, the CE submits a rework request to the DEEOIC Health Physicist because this may mean that covered employment is not established.

(7) For any PoC, if the CE identifies changes to the employment site(s), the CE submits a rework request to the DEEOIC Health Physicist because this may alter the applicable site profile used in assessing occupational radiation exposure.

(8) When a rework is not required, the CE documents the changes to the employment in a memo to file and ensures that the difference(s) between the employment used in the dose reconstruction compared to the DOL-verified employment is noted in the RD. Finally, the CE notifies the NIOSH PHA of the change(s) in employment so NIOSH can update its records.

g. Additional Survivors (Claimants) Identified Rework.

(1) If the PoC is 50% or greater, NIOSH does not need to interview any newly identified claimants. A rework is not required.

(2) If the PoC is less than 50%, a rework request is sent to NIOSH to interview the new claimant(s), at the claimant(s)’ request, to determine if there is some information that could significantly affect the dose reconstruction.

13. Procedures for Requesting Rework. For cases in which the CE determines that a rework is necessary, the CE e-mails his or her assigned Supervisory CE (SCE), SrCE or journey level CE with the amended NRSD attached, noting the issues with the dose reconstruction.

a. The CE’s e-mail includes the following:

(1) Use an e-mail subject that is specific to the individual rework request. For example: DOL Case ID, NIOSH ID Number, DO, and “Rework”, i.e., 1234-NIOSH ID #123456-Denver-Rework.

(2) The CE briefly summarizes how he or she used the current dose reconstruction. Include the employment history used by NIOSH in the dose reconstruction; the cancer(s), diagnosis code(s) and diagnosis date(s) used in the dose reconstruction, and the PoC resulting from this information used in the dose reconstruction.

(3) Describe the reason(s) for the rework request. For example, an additional cancer has been verified, the wrong cancer was reported in the NRSD, the primary cancer was determined for a secondary cancer reported as an “unknown primary,” more or less employment was determined, or the diagnosis date for one of the cancers in the dose reconstruction was found to be incorrect.

(4) Determine whether the employment history and cancer information listed on the Dose Reconstruction Coversheet is the exact information used by NIOSH in the dose reconstruction. If the information reported in the NRSD does not match the information stated on the Dose Reconstruction Coversheet, review the dose reconstruction report, particularly in the sections “Dose Reconstruction Overview,” and “Information Used”, where NIOSH describes in more detail the information used to complete the dose reconstruction. This text may resolve an apparent discrepancy.

(5) Refer to Exhibit 4 for examples of rework requests and types of information needed.

b. The CE prepares an amended NRSD as necessary.

c. To track the action, the CE records the rework request in ECS.

d. The DEEOIC Health Physicist serves as the central liaison between NIOSH and DOL on all issues related to dose reconstruction. If the SCE, SrCE, or journey level CE agrees with the CE’s findings regarding rework, he or she forwards the CE’s e-mail along with the amended NRSD to the DO NIOSH liaison. In turn, the DO NIOSH liaison sends the request along with the amended NRSD to the DEEOIC Health Physicist and copies the CE, SCE, SrCE or journey level CE, and District Director. For instances where the CE determines that a rework request does not need to be forwarded to the DEEOIC Health Physicist (e.g., non-compensable claim with an accepted cancer not included in the dose reconstruction), the CE is to forward the rework request directly to NIOSH.

(1) The DEEOIC Health Physicist reviews the request for rework and determines whether a rework is required.

(2) If the DEEOIC Health Physicist needs additional information to make a determination, which may include requesting the case file, he or she contacts the CE.

e. Rework Not Needed. If the DEEOIC Health Physicist determines that the submitted information does not change the outcome of the dose reconstruction, he or she sends an e-mail to the DO NIOSH liaison, with a copy to the CE, or SCE, and District Director, explaining the rationale for not continuing the review of the dose reconstruction. When the CE receives this response, he or she ensures the response is entered into ECS and proceeds with the IREP calculation.

(1) Updating Records. The CE is responsible for documenting any change to the case records in OIS. This is true regardless of whether the CE submits the case for a rework review by the DEEOIC Health Physicist. The CE is to always document, with memos to file, any analysis that applies to assessing the sufficiency of a dose reconstruction, along with the guidelines used to make that determination.

When the DO makes changes to information used in the NIOSH dose reconstruction, and no rework is required, the DO NIOSH liaison or other designated person sends an e-mail to the appropriate NIOSH PHA. This e-mail indicates what information changed, such as the diagnosis code, cancer name, employment dates, etc.

This allows NIOSH to update its records for the case, which is most critical with respect to changes involving diagnosis codes and PoC values different from those initially generated by the dose reconstruction. Forwarding these changes also allows NIOSH to compile accurate statistics on the types of cancers addressed in EEOICPA decisions that required a NIOSH dose reconstruction.

If a CE performs a new PoC calculation using new information without the need for rework, the DO NIOSH liaison must advise the NIOSH PHA via e-mail and attach the new IREP summary file. For example, in a case with an initial PoC less than 45%, the DEEOIC Health Physicist determined that a change in the diagnosis code did not require a rework of the dose reconstruction, but just a different NIOSH-IREP model run. If the new IREP run resulted in a PoC less than 45%, the CE uses the new IREP run and PoC as the value for the dose reconstruction but must advise NIOSH as noted above.

(2) Any future dose reconstruction rework based on additional verified cancer(s) or employment is performed by NIOSH using only DOL-verified information, which may be more restrictive than information used in the previous dose reconstruction (i.e., in some likely non-compensable cases, NIOSH may assume a continuous employment period rather than considering numerous breaks in employment for the purpose of completing a dose reconstruction in a timely manner). Therefore, it is possible in some cases for the subsequent PoC to remain the same, increase only slightly, or even decrease to some degree if the dose reconstruction is reworked in the future.

f. Rework Needed. If the DEEOIC Health Physicist determines that a rework is necessary, he or she e-mails the CE, SrCE or journey level CE, SCE, District Director and the DO NIOSH liaison. In certain non-standard rework requests, the DEEOIC Health Physicist also copies the designated NIOSH Division of Compensation Analysis and Support (DCAS) contact person(s) on the e-mail.

(1) The CE takes the following actions:

(a) Forward the amended NRSD as an electronic attachment via e-mail to the NIOSH PHA assigned to the DO.

(b) Send a letter to the claimant (Exhibit 5) explaining that the case has been returned to NIOSH for a review of the dose reconstruction.

(c) Send a copy of this letter to the appropriate NIOSH PHA along with the weekly DO submissions to NIOSH.

g. After a revised dose reconstruction report is completed, NIOSH sends it to the claimant along with another Form OCAS-1. The claimant has 60 days to sign and return the form.

14. Comments to Dose Reconstruction Submitted to FAB. A claimant may choose to present comments regarding the findings reported in the NIOSH dose reconstruction. Claimant comments may be submitted for consideration as part of the following circumstances: a request for a review of the written record, oral hearing, or reconsideration; testimony or presentation of exhibits for an oral hearing; or a request for reopening or other post-adjudication action. In these situations, the DEEOIC Health Physicist serves as the initial point of contact for addressing claimant-related comments to a NIOSH dose reconstruction. The CE or assigned DEEOIC FAB staff person takes the following steps to track dose reconstruction comments submitted for DEEOIC Health Physicist review:

a. Prepares a memo to the DEEOIC Health Physicist that identifies all comments related to the NIOSH dose reconstruction.

b. E-mails an electronic version of the memo to the DEEOIC Health Physicist. Attached to the e-mail is a copy of the claimant’s comments/letter of objection, hearing transcript and applicable exhibits, if available. Copies of this e-mail are sent to the supervisor of the assigned CE or DEEOIC FAB staff member and the Policy Branch Program Specialist. The e-mail message should contain the following information in the subject line: the assigned DEEOIC staff member’s FAB or district office location; “Tech Obj”; the DOL Case ID#; and the name of the covered facility, e.g., (FAB NO) Tech Obj-4112(Hanford).

c. Bronzes a copy of the memo with associated documents attached into OIS to document the referral and the person completing the action documents ECS Notes, verifying that the aforementioned actions have been completed.

d. Upon receipt of the comments related to the dose reconstruction, the DEEOIC Health Physicist determines whether the issues raised require further review by NIOSH. As part of this review, he or she will review applicable documents from OIS including: the NIOSH dose reconstruction report, an IREP summary for each cancer, and CATI summary for each claimant from the NIOSH dose reconstruction documentation. If the DEEOIC Health Physicist determines that the issues raised are appropriate for NIOSH review, he or she compiles a package consisting of a copy of the memo from the assigned DEEOIC staff member, a summary of the concerns raised regarding the NIOSH dose reconstruction process or copy of pertinent transcript data from the oral hearing, including exhibits (if applicable), the comments/objection letter from the claimant, and any additional documentation (e.g., exposure data). The DEEOIC Health Physicist submits this package to NIOSH for review and written response. The DEEOIC Health Physicist can consult with NIOSH to clarify whether an issue is appropriate for NIOSH review.

e. Upon receipt of NIOSH’s response, the DEEOIC Health Physicist reviews the response to confirm that it addresses the claimant’s concerns. He or she will add any additional comments, noting that the comments are from DEEOIC, and forward this information to the assigned DEEOIC staff member and his or her respective supervisor via e-mail. Upon receipt of the review of NIOSH’s response, the assigned DEEOIC staff member bronzes the responses into OIS. The assigned DEEOIC staff member incorporates the NIOSH findings into a FD/Remand or other post-adjudicatory decision (e.g, reconsideration, reopening, etc.). The FD/Remand or other post-adjudicatory decision must clearly summarize the claimant’s concerns regarding the dose reconstruction and include a detailed summary of NIOSH’s responses or, when appropriate to provide clarity, a verbatim recitation of NIOSH’s comment response.

f. If the DEEOIC Health Physicist determines that the concerns do not warrant further review by NIOSH, the DEEOIC Health Physicist prepares an e-mail to the assigned DEEOIC staff member and his/her supervisor addressing the issues raised by the claimant regarding NIOSH dose reconstruction. In such instances, the assigned DEEOIC staff member incorporates the findings of the DEEOIC Health Physicist into either a FD/Remand or other post-adjudicatory decision. The FD/Remand or other post-adjudicatory decision must summarize clearly the claimant’s concerns regarding the dose reconstruction and include the DEEOIC Health Physicist’s comments to such concerns.

15. Proving Causation Between Diagnosed Non-SEC Cancer and Covered Employment. Under Part B, a covered employee seeking compensation for cancer, other than as a member of the SEC seeking compensation for a specified cancer, is eligible for compensation if DOL determines that the cancer was "at least as likely as not" (that is, a 50% or greater probability) caused by radiation doses incurred in the performance of duty while working at a DOE facility and/or an AWE facility. DEEOIC uses an algorithmic calculation provided by NIOSH to determine the PoC.

a. Cancers for Which the Primary Site is Unknown. Some claims involve cancers identified by their secondary sites (sites to which a malignant cancer has spread), where the primary site is unknown.

(1) This situation most commonly arises when death certificate information is the primary source of a cancer diagnosis. It is accepted that cancer-causing agents, such as ionizing radiation, produce primary cancers. In a case in which the primary site of cancer is unknown, this means that the primary site must be established by inference to estimate the PoC.

(2) For background purposes, Exhibit 6, which is produced from Table 1 in 42 C.F.R. Part 81, indicates, for each secondary cancer, the set of primary cancers producing approximately 75% of that secondary cancer among the U.S. population (males and females were considered separately). NIOSH performs the dose reconstruction for the cancer site that yields the highest PoC.

If the PoC yields a result greater than 50%, all of the secondary cancers are covered for medical benefits even if no dose reconstruction was performed for that secondary cancer.

b. Cancers of the Lymph Node. The CE considers all secondary and unspecified cancers of the lymph node as secondary cancers (those resulting from metastasis of cancer from a primary site). For claims identifying cancers of the lymph node, Exhibit 6 provides guidance for assigning a primary site and calculating the PoC using NIOSH-IREP.

c. Claims With Two or More Primary Cancers. For these claims, DOL uses NIOSH-IREP to calculate the estimated PoC for each cancer individually. The CE then performs an additional statistical procedure following the use of NIOSH-IREP to determine the probability that at least one of the cancers was caused by radiation (discussed further in the NIOSH-IREP procedures). This approach is important to the claimant because it determines a higher PoC than is determined for either cancer individually.

For cases involving multiple primary cancers where the PoC is greater than 50%, all of the primary cancers will be covered for medical benefits.

d. Claims for Certain Cancers. Sometimes NIOSH guidance requires that a CE run two or three NIOSH-IREP models for a particular cancer. This most often occurs with different types of leukemia. NIOSH only includes the NIOSH-IREP input and associated summary sheet providing the highest PoC in the "Dose Reconstruction Files" in the data sent to the DO.

16. Calculation of PoC Using NIOSH-IREP Computer Program. DOL calculates the PoC for all cancers using NIOSH-IREP. The risk models developed by the National Cancer Institute and the Center for Disease Control for NIOSH-IREP provide the primary basis for developing guidelines for estimating PoC under EEOICPA. They directly address 33 cancers and most types of radiation exposure relevant to claimants covered by EEOICPA. A glossary of cancer descriptions is provided in 42 C.F.R. Part 81 and is produced as Exhibit 7.

a. NIOSH-IREP Operating Guide. The CE uses procedures specified in the NIOSH–IREP Operating Guide to calculate PoC estimates under EEOICPA. The guide provides step-by-step instructions for the operation of NIOSH–IREP. There are two user guides, one for cases with a PoC less than 45% or greater than 52%; and another, termed the Enterprise Edition, for cases with PoCs of 45% to 52%. Enterprise Edition cases can be identified by looking at the Excel input file name which would include the notation “EE.”

(1) For cases with a PoC less than 45% or greater than 52%, the CE accesses NIOSH-IREP on the NIOSH website to perform the PoC calculation. The CE uses data from the CD or electronic record for the NIOSH-provided input file for each cancer.

When two or more cancers are present, the CE uses the multiple primary cancer equation to calculate the total PoC.

(2) For cases with POCs between 45% and 52%, another software program, called the NIOSH-IREP Enterprise Edition (NIOSH-IREP-EE), is used to perform the PoC calculation. The Enterprise Edition is used for this PoC range to achieve better statistical precision and further reduces the chance of denying a claim because of sampling error.

(3) For multiple primary cancers (or secondary cancers with no known primary), the CE performs the NIOSH-IREP-EE calculation for each cancer.

17. Establishing Causation for Cancer Under Part E. EEOICPA presumes medical conditions approved under Part B are caused by exposure to a toxic substance under Part E, so long as there is covered contractor employment and in the case of deceased employees, that a survivor is found eligible.

Exhibit 1: NIOSH Referral Summary Document (NRSD)

Exhibit 2: Instructions for Completing the NRSD

Exhibit 3: NIOSH Referral Letter to Claimant

Exhibit 4: Examples of Rework Request

Exhibit 5: Review of Dose Reconstruction Letter to Claimant

Exhibit 6: Primary Cancer Sites

Exhibit 7: Glossary of Cancer Descriptions