TABLE OF CONTENTS

 

Paragraph and Subject                Page  Date   Trans. No.

 

Chapter 2-0900 Eligibility Criteria for Cancer and Radiation

 

     Table of Contents . . . . . . .   i    01/10     10-07    

  1  Purpose and Scope . . . . . . .   1    01/10     10-07    

  2  Identifying a Claim for

       Cancer. . . . . . . . . . . .   1    01/10     10-07    

  3  Covered Cancers . . . . . . . .   1    01/10     10-07    

  4  Pre-Cancerous and Non-Malignant

       Conditions. . . . . . . . . .   5    01/10     10-07    

  5  Specified Cancers . . . . . . .   5    01/10     10-07    

  6  Non-SEC Cancers . . . . . . . .   6    01/10     10-07    

  7  Non-SEC Cancer and Dose

       Reconstruction. . . . . . . .   6    01/10     10-07    

8         Preparing Non-SEC Cancer Claim

  Files for Referral to NIOSH .   8    01/10     10-07

9         Preparing Amendments to NRSD     

  for Non-SEC Cancer Claims . .   10   01/10     10-07    

10    Cases Pended While at NIOSH . .   11   01/10     10-07

11    Cases Pulled While at NIOSH . .   11   01/10     10-07    

12    NIOSH Actions . . . . . . . . .   13   01/10     10-07    

  13 Receipt of Dose Reconstruction

  Results from NIOSH. . . . . .   16   01/10     10-07    

  14 Review of Claim for Rework

  of Dose Reconstruction. . . .   19   01/10     10-07    

  15 Procedures for Requesting

  Rework. . . . . . . . . . . .   25   01/10     10-07

  16 Reviews of Dose Reconstruction    29   01/10     10-07

  17 Proving Causation Between   

       Diagnosed Non-SEC Cancer and

       Covered Employment. . . . . .   31   01/10     10-07

  18 Calculation of PoC Using

  NIOSH-IREP Computer Program .   35   01/10     10-07

  19 Establishing Causation for

       Cancer under Part E . . . . .   39   01/10     10-07

 

Exhibits

 

  1  NIOSH Referral Summary

       Document (NRSD) . . . . . . .        01/10     10-07    

  2  Instructions for Completing

       the NRSD. . . . . . . . . . .        01/10     10-07

  3  Smoking History Request,

       Form EE/EN-8. . . . . . . . .        01/10     10-07    

  4  Ethnicity Request,

       Form EE/EN-9. . . . . . . . .        01/10     10-07    

  5  NIOSH Referral Letter to

       Claimant. . . . . . . . . . .        01/10     10-07    

  6  Examples of Rework Request. . .           

7         Review of Dose Reconstruction

  Letter to Claimant. . . . . .        01/10     10-07

  8  Primary Cancer Sites. . . . . .        01/10     10-07    

  9  HHS Chronic Lymphocytic

       Leukemia Guideline Letter . .        01/10     10-07

  10 Glossary of ICD-9 Codes and

       Their Cancer Descriptions . .        01/10     10-07    

 


1.    Purpose and Scope.  This chapter discusses the procedures for determining whether an employee has been diagnosed with a covered cancer and the procedures for establishing causation as a result of exposure to 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 expected to identify the specific type of diagnosed cancer on the claim form.

 

3.    Covered Cancers.  Energy Employees Occupational Illness Compensation Program Act (EEOICPA) regulations states that to establish a diagnosis of cancer, medical evidence must be presented which sets forth the diagnosis and the date of the diagnosis.  The CE must verify that sufficient medical evidence is submitted to substantiate a diagnosis of cancer.

 

a.              Diagnosis of Cancer.  The case record must include medical report from a qualified physician that lists a cancer diagnosis. The cancer diagnosis must be based on the following evidence:

 

(1)         Tissue examination is the most conclusive method for making a cancer diagnosis as it provides the physician with the following vital information regarding the tumor or lesion:

 

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

 

(b)  The benign, uncertain, or malignant status.  Only malignant (cancerous) tumors/lesions are addressed in this chapter.

 

(2)  Tissue examinations are described by the following methods:

 

(a)  Pathology report (tissue has been removed from site);

 

(b)  Surgical pathology report (organ, tumor, or lesion has been surgically removed);

 

(c)  Autopsy report; or

 

(d)  Post-mortem examination report.

 

(3)  A diagnosis can sometimes be made based on one or more of the following methods which are listed in order of preference.  If the CE is unable to determine an affirmative diagnosis based on the medical evidence submitted, the case may be referred to a District Medical Consultant (DMC).

 

(a)  Cytology report describes 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.

 

(4)  If the employee is deceased and none of the tests listed above were done, a survivor’s claim will likely be based on official documents.  In this situation the CE must attempt to obtain the documents listed below.  Referral to a DMC should be made only if the CE is unable to determine an affirmative diagnosis.

 

(a)  Hospital admission/discharge reports or physician’s reports describing the tumor;

 

(b)  Hospice records;

 

(c)  If all efforts to obtain additional documents fail, a death certificate signed by a physician may be used to establish a cancer diagnosis. However, a death certificate alone should be used only as a last resort. 

 

b.   Diagnosis of Multiple Primary Cancers.

 

(1)  If more than one primary cancer is identified in the medical evidence in the same organ with the same diagnosis date and the cancers are classified as the same type of cancer, all of the identified cancers are to be considered as only one primary cancer.

 

For example, if three biopsies are taken from the left breast on the same date and all are listed as infiltrating ductal carcinomas, the biopsies are to be considered as indicating only one primary cancer of the left breast.

 

However, if biopsies taken from the left breast on the same date indicate a lobular carcinoma and an infiltrating ductal carcinoma, these cancers are considered as two primary cancers, since the cancer types are different.

 

If a physician clearly notes that there are two (or more) separate primary cancers, the physician’s interpretation prevails whether or not a pathology report confirms multiple primary cancers.

 

(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, 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 impossible to determine whether these two adenocarcinomas are two primary cancers or just one cancer.

 

Cases involving primary cancers identified in bilateral organs and classified as the same type of cancer should be referred to an oncologist DMC for review.  

 

If biopsies identify two different cancers, e.g., a non-small cell adenocarcinoma in the right lung and an oat cell carcinoma in the left lung, these two carcinomas should be considered as separate primary cancers.

 

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 cancer in order for it to be compensable under Part B.  While the date of diagnosis may be noted on Form EE-1 or Form EE-2, the CE must independently review 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 the tissue is obtained should be used as the date of diagnosis. The pathology report must be signed by a physician.   

 

(2)  In certain claim situations, the CE will have to use reasonable discretion in the type of evidence that will be used to accept 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 affidavits from survivor(s) and/or other individuals to establish that the cancer was diagnosed subsequent to the employee’s initial exposure to 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.  However, affidavits may not be used to establish the medical diagnosis itself, only the date of diagnosis.

 

d.   Deficiency in Medical Evidence.  The CE must advise the claimant of any deficiency in medical evidence and allow the claimant a period of up to 60 days to submit additional medical evidence.

 

4.   Pre-Cancerous and Non-Malignant Conditions.  With the types of diagnostic methods described above, some conditions, which could develop into cancer if left untreated, are being diagnosed and treated in the very early stages of development.  If the medical evidence provided by the claimant establishes a diagnosis which demonstrates the condition is in a pre-cancerous stage of development or is non-malignant, the condition is not covered under this chapter and would not be covered under Part B. However, the CE may still need to develop for benefits under Part E for causal relationship between the pre-cancerous conditions or non-malignant conditions and toxic exposure.

 

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 eligible SEC employment.

 

Meeting the criteria of the SEC does not guarantee survivor compensation under Part E. Under Part E, the evidence must also establish that the covered cancer caused, contributed to, or aggravated the death of the employee.

 

6.   Non-SEC Cancers.  Any primary cancer that cannot be considered as a specified cancer for a SEC claim is considered a non-SEC cancer. A primary cancer incurred by an employee at a non-SEC site is also considered a non-SEC cancer. In some cases, a cancer is identified by its secondary site because the primary site is unknown. In these cases, the primary site must be established by inference (see paragraph 17e). If the primary site that was established by inference is not considered a specified cancer, it is also considered a non-SEC cancer.  

 

7.   Non-SEC Cancer and Dose Reconstruction. Once the CE has determined that the employee has a diagnosed non-SEC cancer (other than chronic lymphocytic leukemia (CLL))and covered employment, the claim must be referred to the National Institute for Occupational Safety and Health (NIOSH) for a dose reconstruction to determine the PoC between the diagnosed non-SEC cancer and the dose potentially received during the covered employment. If CLL is the only diagnosed cancer, the CE does not send the case to NIOSH because NIOSH has identified CLL as a non-radiogenic cancer. However, the CE must still develop CLL for toxic substance exposure if there is a claim under Part E. Refer to paragraph 17i for further handling.

 

a.   Claimant Not SEC Member.  When a claim is filed based on SEC membership but the employee is not a SEC member (i.e. the employment was outside the designated SEC time period or the employee did not work the necessary workdays at the SEC site), the CE must forward the claim to NIOSH for dose reconstruction, as long as the employee was diagnosed with a cancer and has confirmed covered employment.

 

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. In these SEC cases, all cancers must be 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 is considered 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, both primary and secondary cancers (prostate and bone cancer) are accepted for medical benefits under Part B. However, per regulation 20 C.F.R. § 30.400, “payment for medical treatment of the underlying primary cancer…does not constitute a determination by OWCP that the primary cancer is a covered illness under Part E of the EEOICPA.” As such, it may 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 in the NIOSH NRSD for dose reconstruction.     

 

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

 

(1)  Each malignant skin neoplasm (e.g., basal or squamous cell cancer) will be considered as a separate primary cancer, unless it is noted in the medical record 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 and should be indicated in the medical section of the NRSD.

 

d.   Multiple Primary Cancers for Other Organs/Locations.  If more than one primary cancer location is identified for an organ in the medical records (e.g., multiple sites of primary cancer in the lung), the CE should note that fact 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 will calculate PoC values for each of the primary cancers in that organ.

 

8.   Preparing Non-SEC Cancer Claim Files for Referral to NIOSH. This preparation includes completion of a NIOSH Referral Summary Document (NRSD).  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. Only the NRSD is approved for use in submitting a case to NIOSH. 

 

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 (Exhibit 3).

 

(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 should clarify the discrepancy with the claimant prior to referral to NIOSH.

 

(3)  If the claimant does not return the initial questionnaire within 30 days, the CE must send a follow-up letter advising that the questionnaire must be returned within the next 30 days or the case will be administratively closed.  After a total of 60 days has elapsed, the CE informs the claimant by letter that the case will be administratively closed under Part B. The case may still be developed for causation based on toxic substance exposure under Part E.  

 

(a)  If the CE can obtain the relevant information from the employee’s medical records or Document Acquisition Request (DAR), the NRSD may be completed using that information and forwarded to NIOSH with an explanation of where the information was acquired.

 

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

 

(1)  The method used to gather this information is Form EE/EN-9 (Exhibit 4).

 

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

 

(3)  If the initial questionnaire is not returned by the claimant within 30 days, the CE must send a follow-up letter advising that the questionnaire must be returned within the next 30 days or the case will be administratively closed.  After a total of 60 days has elapsed, the CE informs the claimant by letter that the case will be administratively closed. 

 

If the CE can obtain the relevant information from the employee’s medical records or DAR, the NRSD may be completed using that information, and forwarded to NIOSH with an explanation of where the information was acquired.

 

d.   Case Referred to NIOSH.

 

(1)  The evidence in file must support any finding made by the CE and documented in the NRSD. The CE must make a copy of the NRSD and place it in the case file. 

 

(2)  A copy of the entire case file is forwarded with the NRSD to NIOSH.   

 

(3)  The CE advises the claimant in writing that the case has been sent to NIOSH for dose reconstruction (Exhibit 5).

 

9.   Preparing Amendments to NRSD for Non-SEC Cancer Claims.  Sometimes CEs obtain additional information on a case after it has been referred to NIOSH but before the completion of the dose reconstruction.  This includes new information related to the employee’s employment, new medical condition(s), or other survivor-related information.    

 

When new information become available, this information must be forwarded to NIOSH so it is available for dose reconstruction.  The CE must include the portion of the NRSD that has changed based on new evidence reviewed by the District Office (DO).  Mark “Amendment” on the top of the NRSD and include the employee's name, DOL case number, NIOSH tracking number, and DOL Information (including the Senior CE or journey level CE’s signature).  The CE clearly identifies and separates any “Amendment” NRSDs from NRSDs that are submitted with the DO’s weekly package to 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.  The CE responsible for the case(s) listed on the report must review the information in the case file against the information sent to NIOSH in the NRSD.  Any revisions to information contained in the original NRSD must be forwarded to NIOSH using an amended NRSD.  This will allow NIOSH to use the correct 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, this must be submitted using a NRSD with “Supplement” marked, and only the DOL case number, NIOSH tracking number, and employee’s name need be included. A supplemental NRSD should be used only for a submission that does not change the original information in the NRSD. Clearly mark any supplemental packages and separate them from NRSDs that are submitted with the DO’s weekly package to NIOSH. 

 

10.  Cases Pended While at NIOSH.  During the dose reconstruction process, NIOSH may place a case in a “pend status” for technical reasons. Examples may include: the addition of time to a facility’s covered period; a technical dose reconstruction issue for a facility; or a change to a site profile, based on the identification of additional dose data.

 

Placement in pend status does not stop the dose reconstruction process, but may delay completion of the dose reconstruction.  Placing a case in a pend status alerts the NIOSH staff that clarification is needed on a specific issue that may affect the dose reconstruction. DOL is not necessarily notified of a case placed in pend status for technical reasons or when these issues are resolved.   

    

11.  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.  All contact from NIOSH is to be handled as quickly as possible, and a response provided within three working days.  If the question cannot be answered without further development, the CE advises NIOSH of the steps being taken and an approximate time frame 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 email. 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, Senior CE (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 status 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, DOL staff notifies the appropriate 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 must also prepare and forward, as necessary, an amended NRSD containing the new information. The CE must also advise the claimant in writing that the case is removed from pulled status and dose reconstruction may proceed.

 

b.   Cases Pulled Due to SEC. NIOSH may identify cases submitted for dose reconstruction that should be considered for inclusion in a SEC class, typically when a new SEC class is designated. NIOSH pulls these cases from the dose reconstruction process and returns these cases with the dose reconstruction analysis records in the form of a CD to the appropriate district office for further development. NIOSH also sends a letter advising the claimant that his or her claim is being returned to DOL for adjudication.

 

If DOL identifies a case that qualifies under the SEC provision but was not pulled by NIOSH from the dose reconstruction process, the CE, through the Senior CE (SrCE) or journey level CE, notifies the appropriate NIOSH PHA via e‑mail to return the dose reconstruction analysis records for further development.  In these cases, the CE will send a letter to the claimant advising that the 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 for inclusion in the case file. 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-work-day 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.

 

12.  NIOSH Actions.  Upon receipt of a claims package from DOL, NIOSH takes several actions to determine the employee’s radiation dose.

 

a.   Request DOE Records.  These records will include radiation dose monitoring and radiation exposures associated with the employment history.

 

b.   Interview the Claimant(s).  The purpose of the interview(s), also known as the Computer Assisted Telephone Interview (CATI), is to identify any additional relevant information on employment history and develop detailed information on work tasks and radiological exposures.

 

c.   Apply Dose Reconstruction Methods.  This allows NIOSH 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 Department of Energy (DOE) or Atomic Weapons Employer (AWE) facility.

 

d.   Conduct Closing Interview.  After providing the claimant with a copy of a draft dose reconstruction report, NIOSH conducts a closing interview with the claimant to review the dose reconstruction results and the basis upon which the results were calculated.  This is the claimant’s final opportunity during the dose reconstruction process to correct or provide additional information that may affect the dose reconstruction.

 

e.   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)  The claimant’s signature on Form OCAS-1  does not mean that the claimant agrees with the dose reconstruction.  Rather, the claimant is agreeing to the process and that he or she provided NIOSH with all relevant evidence.

 

(b)  If the claimant or the authorized representative fails to 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.   

 

(c)  Upon receiving this notification by NIOSH, the CE must also administratively close DOL’s claim by entering a "NO" in the case status screen, since DOL cannot determine the PoC, a necessary step in adjudication of the claim, without a dose reconstruction estimate produced by NIOSH.  The CE enters the date of receipt of the NIOSH letter (date stamp) as the status effective date.

 

(d)  If the employee meets the employment requirements, prior to entering the administratively closed code (“NO”) in Part E ECMS, the CE must determine 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.  If no causal link is established, the CE places a “Memo to the File” explaining the sequence of events and then administratively closes the case in ECMS Part E.

 

(e)  The CE must advise the claimant by letter that the case is closed.  If the claimant later decides to sign the Form OCAS-1, he or she will be required to notify DOL, after which the claim will be referred back to NIOSH for reopening.  The claimant should be advised that DOL cannot complete adjudication without NIOSH’s findings.

 

(f)  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 must also administratively close DOL’s claim in accordance with paragraph 12e(1). If, after 60 days, NIOSH receives only one signed Form OCAS-1, NIOSH will forward the dose reconstruction package to DOL.

(a)  The CE writes to the claimant(s) who did not sign Form OCAS-1 and ask why he or she did not sign Form OCAS-1.  The claimant(s) should be asked to provide this information within 30 days.  The CE should consider any arguments given by the claimant(s), and if substantive, refer the case back to NIOSH.  Substantive arguments may include discovery of additional relevant information related to dose reconstruction, e.g., information or documents concerning radiological exposures, other co-workers, or operations and radiological controls at the specific facility. 

 

(b)  If arguments for refusals to sign are not provided or not substantive, or if no response is received within 30 days, the CE should issue a Recommended Decision (RD) awarding (or denying) benefits to all eligible claimants (even those claimants who did not sign the form).  One signed Form OCAS-1 is sufficient to proceed with issuing a decision.

 

13.  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.  When the case is returned to DOL, NIOSH will forward all case file documents via compact disc (CD), since all documents referred to NIOSH and used in the dose reconstruction are optically scanned into the NIOSH computers.  NIOSH will uniquely identify (on the label on the CD case) the employee’s Social Security number.  The CD will include the dose reconstruction input file (Excel spreadsheet) to be used for calculating the IREP probability of causation. The NIOSH CD should be kept with the case file.

 

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

 

     (a)  Dose reconstruction files, 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 all important information from the above sources into the dose reconstruction report.  Publicly available documents will be referenced by citation.  Documents not publicly available will be placed in the record and, as noted above, will be included on the CD.

 

(3)  The CE need not review all of the documents on the CD.  Those documents that normally will not require review include the DOE documents, the claimant interview, the NIOSH-run PoC calculation, and the NIOSH-conducted closing interview.

 

NIOSH runs the PoC calculation to reduce the time needed to complete the dose reconstruction, and the PoC results are incorporated into the dose reconstruction findings.  NIOSH’s IREP run is used for its internal purposes only, and the CE should not use NIOSH’s IREP calculations as a basis for a determination in the claim.  The CE must always run the IREP separately.

 

(4)  NIOSH will have the pertinent documents (dose reconstruction report, other records of import to the CE) in a directory titled “A_DR Files” so that the CE can include those documents in the hard copy for review. The CE prints the dose reconstruction report and the signed Form OCAS-1 and includes them in the case file.

 

After running the PoC calculation, the CE prints and retains a hard copy of the DOL IREP run in the case file.

 

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 dose potentially received by the  employee.  In these situations, NIOSH notifies any claimant for whom a dose reconstruction cannot be completed and describes the basis for this finding.  NIOSH forwards its determination to DOL and the CE issues a Recommended Decision (RD) to deny the claim based on NIOSH’s inability to complete the dose reconstruction.

 

The CE notes in the decision the claimant may pursue the SEC petition process per 42 C.F.R. Part 83.13 or 83.14.  The claimant has the opportunity to seek administrative review of this result after a Final Decision to deny the claim.

 

14.  Review of Claim for Rework of Dose Reconstruction. The CE must compare the dose reconstruction (DR) 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 DR report, including erroneous or incomplete information, or for which new information was recently received, the CE must determine 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 ICD-9 code, or change in date of cancer diagnosis.

       

     a.   Cancer Changes Rework.

 

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

 

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

 

(b)  PoC is 50% or greater, a rework is not required.  All additional primary cancers would be eligible for medical benefits.  The CE documents the newly identified cancer(s) in the case file and notifies the NIOSH PHA of the additional cancer(s) so NIOSH can update their records.

 

(2)   If two or more primary cancers are addressed in the DR, and it is later determined that one or more of the cancers should not have been included in the DR (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 should: use the PoC as calculated as the PoC of record and note appropriately; document the discrepancy between the cancer(s) identified in the DR 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 NIOSH can update its records.

 

(b)         If PoC is 50% or greater, submit a rework request to the DEEOIC Health Physicist.  Also, if a primary cancer addressed in the DR is subsequently found to be a secondary cancer with an unknown primary, or an in-situ cancer, submit a rework request to the DEEOIC Health Physicist.

 

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

 

b.   Smoking and Race/Ethnicity Changes Rework.  If information related to race/ethnicity or smoking history changes after the DR is performed, the CE should re-run 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.   ICD-9 Code Changes Rework. Changes can affect the internal and/or external dose models used in the DR and/or the IREP model.  Accordingly, the CE submits a rework request for changes in ICD-9 codes, other than those exceptions listed below, to the DEEOIC Health PhysicistIf the ICD-9 code changes within the following series, no rework is required (e.g., 188.8 to 188.5):

 

Series

Cancer

Internal (IMBA) Organ

External Organ

IREP Model

151

Malignant Neoplasm Stomach

Stomach

Stomach

Stomach

152

Malignant Neoplasm Small Bowel

Small Intestine

Stomach

All digestive

154

Malignant Neoplasm Rectum/Anus

LLI

Colon

Rectum

156

Malignant Gallbladder /Extra hepatic

Gallbladder

Bladder

Gallbladder

157

Malignant Neoplasm Pancreas

Pancreas

Stomach

Pancreas

161

Malignant Neoplasm Larynx

Extra-thoracic (ET2)

Esophagus

Other Respiratory

162

Malignant Neoplasm Trachea/Lung

Lung

Lung

Lung

174

Malignant Neoplasm Female Breast

Breast

Breast

Breast

175

Malignant Neoplasm

Male Breast

Breast

Breast

Breast

180

Malignant Neoplasm Cervix Uteri

Uterus

Uterus

Female genitalia less ovary

182

Malignant Neoplasm Uterus Body

Uterus

Uterus

Female genitalia less ovary

186

Malignant Neoplasm Testis

Testes

Testes

All male genitalia

188

Malignant Neoplasm Bladder

Bladder

Bladder

Bladder

232

Carcinoma in situ skin

Skin

Skin

Malignant Melanoma AND

Non-melanoma skin-Squamous cell

 

(1)  For ICD-9 code 232.0, 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.

 

(2)  This table is excerpted from NIOSH document ORAUT-OTIB-0005, “Internal Dosimetry Organ, External Dosimetry Organ, and IREP Model Selection by ICD-9 Code”.

 

d.   NIOSH-IREP Changes Rework.  If the ICD-9 code changes, but the organs used by NIOSH for calculating internal and external dose remain the same (only the IREP model organ changes), the DO should request direction by the DEEOIC Health Physicist for instructions to rerun IREP for the proper IREP cancer model (organ). 

 

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 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 the DEEOIC Health Physicist.

 

(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, but still within 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 the DEEOIC Health Physicist. 

 

(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 DR is noted in the RD.

 

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

 

    f.   Employment Changes Rework.

 

(1)         If the PoC is 50% or greater and additional DOL-verified employment is identified, 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 DR, the CE submits a request for rework to the DEEOIC Health Physicist for review, and includes an electronic copy of the DR report.

 

(3)         If the PoC is between 40% and 49.99%, and additional DOL-verified employment is identified, the CE submits a request for rework to the DEEOIC Health Physicist for review, and includes an electronic copy of the DR 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 DR, a rework is not required.

 

(b)         If the additional employment extends into, or is wholly within another calendar year not addressed in the DR, the CE submits a rework request to the DEEOIC Health Physicist.

 

(5)         Some DRs 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 DR 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 DR 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 the purpose of completing the DR 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 DR.  This must also be explained in the RD. 

 

If NIOSH has added employment to a claim that is likely compensable, NIOSH must contact the CE with the additional employment information for DOL review and verification. After verification the CE must submit an amended NRSD to NIOSH.

 

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

 

(6)         If military, navy nuclear, or non-DOE federal service is identified in the DR, the CE submits a rework request to the DEEOIC Health Physicist.

 

(7)         For any PoC, if changes to the employment site(s) are identified, the CE submits a rework request to the DEEOIC Health Physicist. 

 

(8)         When a rework is not required, the CE must still document the changes to the employment in a memo to file and ensure that the difference(s) between the employment used in the DR 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%, NIOSH will interview the new claimant(s), at the claimant(s)’ request, to determine if there is some information that could significantly affect the DR and therefore prompt the submission of a rework request to the DEEOIC Health Physicist. 

 

15. Procedures for Requesting Rework. For cases in which the CE determines that a rework is necessary, the CE must e-mail the Supervisory CE (SCE), SrCE or journey level CE with the Amended NRSD (ANRSD) attached, noting the issues with the DR.

 

a.   A copy of the e-mail message (printed from the sent file to document the date of issue) must be placed in the case file.

         

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

 

(2)  Briefly summarize how the current NIOSH DR was performed.  Include the employment history used by NIOSH in the DR; the cancer(s), ICD-9 code(s) and diagnosis date(s) used in the DR, and the PoC resulting from this information used in the DR.

         

(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 DR was found to be incorrect.

         

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

         

(5) Refer to Exhibit 6 for examples of rework requests and types of information needed.

 

b.   An amended NRSD is prepared as necessary. 

 

c.   The PoC value is not entered in ECMS when a case is referred back to NIOSH. If a PoC value is already entered, the CE deletes the previous PoC value.

 

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 e-mail findings regarding rework, he or she must forward 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.

    

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

 

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

    

e.   Rework Not Needed. If the DEEOIC Health Physicist determines that information would not change the outcome of the DR, he or she will send 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 DR.  When the CE receives this response, he or she must print the e-mail for the case file and proceed with the IREP calculation and enter the PoC value(s) into ECMS.

    

(1)  Updating Records.  Any changes made to a case with a DR, regardless of whether the case is submitted for a formal rework review by a DEEOIC Health Physicist, should be documented in the case file and should reference the guidelines used to make that determination.

 

When the DO makes changes to information used in the NIOSH DR, 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 must indicate what information was changed, such as the ICD-9 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 ICD-9 codes and PoC values different from those initially generated by the dose reconstruction.  Forwarding these changes also allows NIOSH to more accurately compile statistics on the types of cancers addressed in EEOICPA decisions that required a NIOSH DR. 

 

If a new PoC calculation was performed 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 that 45%, the DEEOIC Health Physicist determined that a change in the ICD-9 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 may use the new IREP run and PoC as the value for the dose reconstruction but must advise NIOSH as noted above.

 

(2)  If the DEEOIC Health Physicist has determined that a rework is not necessary, but discrepancies appear to exist between the NIOSH dose reconstruction and DOL’s analysis of the DR and subsequent calculation of the PoC (e.g., one or more cancers were subsequently deemed not covered, changes in the diagnosis date, differences in NIOSH employment dates and DOL-verified employment dates) the CE addresses the discrepancies in the RD.

 

(3)  Any future DR rework based on additional verified cancer(s) or employment will be performed using only DOL-verified information, which may be more restrictive than information used in the previous DR (i.e., in some likely non-compensable cases, NIOSH may assume a continuous employment period rather than considering numerous breaks in employment for purpose of completing a DR 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 DR is reworked in the future.  

 

f.   Rework Needed.  If the DEEOIC Health Physicist determines that a rework is necessary, he or she will e-mail the CE, SrCE or journey level CE, SCE, District Director and the DO NIOSH liaison to proceed. In certain non-standard rework requests, the DEEOIC Health Physicist will also copy the designated NIOSH Office of Compensation Analysis and Support (OCAS) contact person(s) on the e-mail.  The CE must place a copy of the e-mail in the case file.

 

(1)  The CE must take 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 7) 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.  The dates on the amended NRSD and the letter to the claimant must be the same, since this will be the date used for the new status code entry into ECMS.

 

g.   After a new draft dose reconstruction (DR) report is completed, NIOSH will send it to the claimant along with another Form OCAS-1.  The claimant has 60 days to sign and return the form.

 

16.  Reviews of Dose ReconstructionIf the claimant objects to NIOSH’s decision on the results of the dose reconstruction, the objection must be filed with the FAB. FAB evaluates the factual findings upon which NIOSH based the dose reconstruction. All objections related to dose reconstruction must be sent to a DEEOIC Health Physicist for review, unless the objections are solely related to factual findings, i.e., whether the facts upon which the dose reconstruction report was based were correct. 

 

a.   Factual Objection:  If the HR or CE determines that the factual evidence reviewed by NIOSH was properly addressed, the HR or CE accepts NIOSH’s findings, in which case no referral to a DEEOIC Health Physicist is necessary.  However, if the HR or CE determines that NIOSH did not review substantial factual evidence, he or she contacts a DEEOIC Health Physicist to determine if a rework of the dose reconstruction is necessary.

 

If the DEEOIC Health Physicist determines that a rework of the dose reconstruction is necessary, the HR or CE then remands the case to the DO for referral to NIOSH for a rework.     

 

b.   Technical Objection:  A technical objection may involve either methodology or application of methodology.  Examples of methodology of dose reconstruction may include but is not limited to analyzing specific characteristics of the monitoring procedures in a given work setting; identifying events or processes that were unmonitored; identifying the types and quantities of radioactive materials involved and using current models for calculating internal dose. The NIOSH "efficiency" process of using overestimates and underestimates in dose reconstruction is another example of a methodology. Upon receipt of the technical objection(s), the HR or CE discusses it with his or her supervisor to obtain approval to submit the objection(s) for DEEOIC Health Physicist review.  Following are steps taken to track technical objections submitted for DEEOIC Health Physicist review:

 

(1)  The HR or CE prepares a memo to the DEEOIC Health Physicist that identifies only the dose reconstruction-related technical objections (not including any factual objections).

 

(2)  The HR or CE attaches electronic version of the memo (in addition to the NIOSH dose reconstruction report, IREP summary for each cancer and CATI summary for each claimant from the NIOSH disc) to an e-mail message addressed to the DEEOIC Health Physicist with copies to the FAB supervisor and FAB support team.  The e-mail message should contain the following information in the subject line: the HR or CE’s FAB office location; “Tech Obj”; the last 4 digits of the claim #; and the name of the covered facility, e.g., (FAB NO) Tech Obj-4112(Hanford). 

 

(3) The HR or CE spindles the memo in the file and documents ECMS Notes to explain that supervisory approval has been granted and that the aforementioned actions have been completed.

 

(4) Upon receipt of the technical objection(s), the DEEOIC Health Physicist determines whether the technical objection is one of application or methodology.  Methodology used by HHS in arriving at reasonable estimates of the radiation doses received by an employee, established by regulations issued by HHS at 42 CFR Part 82, is binding on FAB. Objections concerning the application of that methodology (20 CFR § 30.318) is referred by the DEEOIC Health Physicist to NIOSH for their opinion. NIOSH is asked to respond within 30 days. The DEEOIC Health Physicist then sends his or her written opinion (and NIOSH’s opinion, if any) to FAB. Upon receipt of the DEEOIC Health Physicist’s review of technical objections, the HR or CE spindles the responses in the file. If the case needs to be reviewed by NIOSH, the FAB will be instructed to remand the case back to the DO for referral to NIOSH.

 

17.  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 only 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 Atomic Weapons Employer (AWE) facility.

 

 This includes radiation doses from medical X-rays for the pre-employment physical examination, annual physical examinations, and a termination (exit) physical examination, but does not include radiation to which the employee may have been exposed during airline flights, as such exposures are not incurred from activities at the sites.

 

EEOICPA does not include a requirement limiting the types of cancers to be considered radiogenic; CLL is considered non radiogenic pursuant to HHS regulation. 

 

a.   NIOSH-IREP.  The CE must use the updated version of radioepidemiological tables developed by the National Institutes of Health as a basis for determining PoC.  This software program, named the NIOSH-Interactive RadioEpidemiological Program (NIOSH-IREP), is based on NIOSH regulations found at 42 C.F.R. Part 81.  NIOSH-IREP allows the CE to apply the National Cancer Institute risk models directly to data on individual claimants.

 

b.   Uncertainty.  NIOSH-IREP allows the CE to take into account uncertainty concerning the information being used to estimate PoC.  There typically is uncertainty about the radiation dose levels to which a person has been exposed, as well as uncertainty relating to levels of dose received to levels of cancer risk observed in study populations. 

 

Accounting for uncertainty is important because it can have a large effect on the PoC estimates.

 

c.   Credibility Limit.  As required by the Act at Section 7384n(c)(3)(A), the NIOSH-IREP uses the upper 99 percent credibility limit to determine whether the cancers of employees are at least as likely as not caused by their occupational radiation doses.  This helps minimize the possibility of denying compensation for those employees with cancers likely to have been caused by occupational radiation exposures.

 

d.   Guidelines.  Specific guidelines concerning the calculation of the PoC for certain cancers are noted below.

 

(1)  Carcinoma in situ (CIS), or cancers in their early stages, are not specifically included in NIOSH-IREP models. These lesions are becoming more frequently diagnosed, as the use of cancer screening tools, such as mammography, has increased in the general population.  The risk factors and treatment for CIS are frequently similar to those for malignant neoplasms, and, while controversial, there is growing evidence that CIS represents the earliest detectable phase of malignancy.  Therefore, for purposes of estimating PoC, carcinoma in situ (ICD–9 codes 230–234) should be treated as a malignant neoplasm of the specified site.

 

Current NIOSH guidance on which IREP models to run for in situ squamous cell carcinoma (SCC) skin cancer is contained in Table 4, “Cancer Models to be Used in the Calculation of Probability of Causation,” in the NIOSH-IREP Technical Documentation.  The guidance in the table directs the use of two models for in situ skin cancer cases.  For the ICD-9 code 232 series the CE must use the IREP models for both malignant melanoma and non-melanoma skin-squamous cell.

 

When a physician specifically identifies the in situ skin cancer as squamous cell carcinoma (SCC), the IREP guidance in the above-mentioned tables is not applicable and the CE must run the SCC model only.  If not so identified, then the CE continues to run both models for in situ skin cancers.

 

(2)  For other cancers requiring the use of NIOSH-IREP, the CE must assume that neoplasms of uncertain behavior (ICD–9 codes 235–238) and neoplasms of unspecified nature (ICD–9 code 239) are malignant, for purposes of estimating PoC.

 

e.   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 PoC.

 

(2)  For background purposes, Exhibit 8, which is reproduced 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 PoC greater than 50%, all of the secondary cancers are covered for medical benefits even if no dose reconstruction was performed for that secondary cancer.

 

f.   Cancers of the Lymph Node.  The CE must consider all secondary and unspecified cancers of the lymph node (ICD-9 code 196.0) as secondary cancers (those resulting from metastasis of cancer from a primary site).  For claims identifying cancers of the lymph node, Exhibit 8 provides guidance for assigning a primary site and calculating the PoC using NIOSH-IREP.

 

g.   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.

 

h.   Claims for Leukemia. Sometimes NIOSH guidance requires that two or three NIOSH-IREP models be run 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 "DR Files" on the disk sent to the DO. 

 

i.   Claims for Chronic Lymphocytic Leukemia (CLL) Only. CLL is a form of leukemia not found to be radiogenic in studies conducted worldwide of a wide variety of radiation-exposed populations.  Therefore, pursuant to HHS regulations, the PoC for CLL is assigned a value of zero. The CE will insert Exhibit 9 into the file for the record.  Exhibit 9 is a letter from NIOSH that states the Department of Health and Human Services (HHS) guidelines for determining the PoC for CLL.  Since CLL has a PoC of zero, the CE adjudicates the claim without sending the case to NIOSH. The RD must contain a reference to the DHHS regulations and cite 42 C.F.R. § 81.30 denying compensation benefits under Part B of the Act. 

 

(1) In cases where there are multiple primary cancers including CLL, and the PoC is greater than 50%; medical benefits will be covered for CLL. When CLL is diagnosed after an award has been made for a greater than 50% PoC, medical benefits are paid for CLL.

 

(2) CLL may be compensable under Part E of the Act.  The CE must determine if causation can be established for CLL and exposure to toxic substances other than radiation under Part E.

 

18.  Calculation of PoC Using NIOSH-IREP Computer Program.  DOL must calculate the PoC for all cancers, except CLL, 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.   NIOSH Cancer Models.  The NIOSH Cancer Models take into account the employee’s cancer type, year of birth, year of cancer diagnosis, and exposure information such as years of exposure, as well as the dose received from gamma radiation, X-rays, alpha radiation, beta radiation, and neutrons during each year. A glossary of cancer descriptions for each ICD-9 code is provided in 42 C.F.R. Part 81 and is reproduced as Exhibit 10.

 

b.   Smoking History and Racial/Ethnic Identification.  The risk model for lung cancer takes into account smoking history.  The risk model for skin cancer takes into account the race or ethnic identification of the claimant. (However, it does not consider exposure to sunlight, since sunlight is not a toxic substance.)

 

None of the risk models explicitly account for exposure to other occupational, environmental, or dietary carcinogens.  For cases with lung (primary or secondary, with unknown primary) or skin cancer, the CE must determine the smoking history or race or ethnic identification of the claimant.

 

c.   Risk Models.  NIOSH-IREP is specifically designed for adjudication of claims under EEOICPA and incorporates cancer risk models that have been modified to reflect the radiation exposure and disease experiences of employees covered under EEOICPA.

 

d.   NIOSH-IREP Operating Guide.  The CE must use 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.  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.  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 at http://198.144.166.6/irep_niosh/ to perform the PoC calculation.  The CE must use data from the CD for the NIOSH-provided input file for each cancer.

 

After the IREP calculation is completed for each cancer, the CE prints out the NIOSH-IREP PoC results directly from the web page and retains it in the case file.  The copy shows the web page address and date at the bottom, which documents that the CE independently ran the IREP.

 

When two or more cancers are present, the CE uses the multiple primary cancer equation to calculate the total PoC, and saves this report as a hard copy. 

 

(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 website address for the program, the User’s Manual, and the password (which NIOSH will change every few months), is available by contacting the DOL Health Physicist. 

 

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.

 

In summary, the simulation sample size will be increased to 10,000; 30 additional IREP runs will be performed using a new random number seed for each run; and the average value of the upper 99% credibility limit (CL) of the 30 runs (PoC) will determine the claim outcome.

 

(a)  To facilitate the 30-run process, another Excel input file is used specifically for this software.  This input file contains all the claims data found in the regular NIOSH-IREP input file, but are preset with 30 different random number seeds and a simulation sample size of 10,000.

 

(b) NIOSH will provide this preset file (or files, if there is more than one primary cancer) for each claim that falls into the PoC range.  To perform the required calculations, this input file need only be uploaded once into NIOSH-IREP-EE.

 

(c) After the CE uploads the file and clicks the “Generate 30 Results” button, the input is submitted to the NIOSH-IREP-EE server where the calculations are to be performed. Upon completion, the results are displayed in the form of IREP Summary Report. They will include the average value of the upper 99% CL of the PoCs for the 30 results. 

 

(d) While the CE waits for the results to be returned, the computer may be used for other tasks.  However, clicking on an internet link in an e-mail while the file is running will disrupt the calculation process.  To access the internet while waiting for the calculations to be performed, a new and separate instance of the browser should be opened.

 

(e) Since some calculations could take over two hours to complete, it may be best to run the NIOSH-IREP-EE at the end of the day to allow the computer to process overnight. When complete, the calculations will remain on the CE’s screen to be printed and saved the next morning.

 

(3)  For multiple primary cancers (or secondary cancers with no known primary), the CE performs the NIOSH-IREP-EE calculation for each cancer.  As with the standard NIOSH-IREP, the PoC results must be printed and placed in the case file.

 

19.  Establishing Causation for Cancer Under Part E.  Coverage under Part E is limited to confirmed DOE contractor employees or RECA Section 5 uranium workers who contracted any diagnosed illness (this Chapter focuses on cancer) after beginning employment at a DOE facility or a RECA Section 5 facility.  Certain RECA Section 4 eligible claimants who have not received any Section 4 benefits may also be eligible for EEOICPA benefits if otherwise eligible under EEOICPA. To establish causation under Part E, evidence must show that it is “at least as likely as not” that the exposure to a toxic substance (which may include radiation) at a DOE facility or certain RECA facilities was a significant factor in causing, contributing to, or aggravating the covered illness. In certain cases, there is a presumption of causation under Part E.

 

a.   Presumption of Causation:

 

1.   Approved Part B Conditions.  Medical conditions approved under Part B are given a presumption of causation under Part E. As such, an acceptance for a medical condition under Part B will correlate to an automatic acceptance under Part E for the same medical condition.

 

2.  DOE Physician’s Panel.  If, under former Part D, a DOE physician’s panel finding signed by a DOE official provides the opinion that the employee sustained an illness or died due to a toxic substance at a DOE facility, the CE accepts the determination for causation under Part E.

 

3.   SEC Cases. A determination that an employee is entitled to compensation based on meeting the criteria required under SEC establishes causation for that cancer under Part E (non-SEC cancers must be developed for causation).  However, for claims involving survivors, evidence must establish that the covered cancer was a significant factor that caused or contributed to the death of the employee.

    

4.   RECA Section 5. Conditions approved under Part B based on a RECA Section 5 awarded to a living employee will correlate to an automatic acceptance under Part E to the same living employee for the same medical condition. However, survivors of Section 5 RECA award recipients, and survivors who are award recipients in their own right, must submit the requisite documents to establish survivorship eligibility under Part E. All Part E survivorship rules apply to RECA survivors. 

 

b.   Causation Development of Non-SEC Cancer Cases.  Under Part E, non-SEC cancer cases without presumption of causation are developed for causation by evaluating the causal nexus between the cancer and potential occupational exposure to radiation and/or other toxic substances at a covered facility.  While development actions for radiation and other toxic substances (non radiation) exposures have distinct paths, they are undertaken concurrently to determine whether or not a claimant meets the causation test under Part E. 

 

(1)  When developing a cancer claim for causation due to radiation, the CE refers the case file to NIOSH for dose reconstruction in accordance with the instructions in this Chapter. The CE must determine whether or not the cancer is “at least as likely as not” related to the verified covered employment at a DOE or RECA facility. The “at least as likely as not” causation standard is met if the PoC is 50% or greater. 

    

Part E claims based on RECA Section 5 employment that are for cancers other than those accepted by DOJ (i.e., lung cancer) are also referred to NIOSH for dose reconstruction and determination of the PoC.

 

(2)  In conjunction with the dose reconstruction, the CE develops the Part E cancer claim for causation based upon toxic substance other than radiation.

 

(3)  A cancer claim may meet the causation test by either means: 

 

(a)  If the dose reconstruction results in a PoC of 50% or greater, the CE issues a RD to accept the claim under Part B and/or Part E.  In a survivor case, the CE must also establish that the covered cancer was at least as likely as not a significant factor that caused, contributed to or aggravated the death of the employee.

 

(b)  If the CE is able to establish toxic exposure causation and no Part B benefits are claimed, the CE renders a factual determination as to acceptance under Part E only and issues the RD. If the case is pending at NIOSH for a dose reconstruction, the CE pulls the case file from NIOSH without waiting for the dose reconstruction to be completed. For example, a claimant is the survivor of a uranium miller covered under Section 5 of the RECA.  The claimant is seeking survivorship benefits under Part E based upon a claim of esophageal cancer.  No Part B benefits are being sought, as the survivor was awarded Part B benefits as a RECA Section 5 beneficiary, and is not eligible for Part B benefits under the esophageal cancer claim.  In this case only Part E benefits are sought for the cancer claim, and should the CE establish a causal link between the esophageal cancer and exposure to a toxic substance at a RECA mine, the claim can be immediately accepted and withdrawn from NIOSH without waiting for the dose reconstruction.  

 

If, however, Part B benefits are also claimed, the case file remains at NIOSH until the dose reconstruction is complete so a RD can be issued for both Parts B & E at the same time.

 

(4)  In certain instances a physician might opine that a claimant’s radiation and toxic substance exposure together worked in tandem to produce a synergistic or additive effect that brought about the cancer.  DOL has not found scientific evidence establishing a synergistic or additive effect between radiation and exposure to a toxic substance, and if the physician presents this finding he or she must provide actual scientific or medical research evidence to support the finding before the CE may consider the assertion.

 

If a physician makes this assertion, the CE requests that the physician provide medical evidence of a synergistic or additive effect and a clearly rationalized medical opinion as to whether or not the effect is significant enough to establish that the combination of the radiation and the exposure to a toxic substance was “at least as likely as not” a significant factor in aggravating, contributing to, or causing the cancer. 

 

If the physician provides rationalized scientific evidence revealing a synergistic or additive effect, the DO sends the case file to NO for review by a NO Health Physicist (HP), Toxicologist and/or the DEEOIC Medical Director.  The HP reviews the physician’s report and all evidence of file and makes a recommendation as to causation.

 

 

Exhibit 1: NIOSH Referral Summary Document (NRSD)

Exhibit 2: Instructions for Completing the NRSD

Exhibit 3: Smoking History Request, Form EE/EN-8

Exhibit 4: Ethnicity Request, Form EE/EN-9

Exhibit 5: NIOSH Referral Letter to Claimant

Exhibit 6: Examples of Rework Request

Exhibit 7: Review of Dose Reconstruction Letter to Claimant

Exhibit 8: Primary Cancer Sites

Exhibit 9: HHS Chronic Lymphocytic Leukemia Guideline Letter

Exhibit 10: Glossary of ICD-9 Codes and Their Cancer Descriptions