Issue Date: February 17 , 2009
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Effective Date: February 17 , 2009
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Expiration Date: February 17 , 2010
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Subject: Mallinckrodt Chemical Company, Destrehan Street Plant, 1958 SEC class.
Background: Pursuant to the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA) and 42 C.F.R. Part 83, a petition was filed on behalf of workers from the Mallinckrodt Chemical Company, Destrehan Street Plant (Mallinckrodt) in St. Louis, Missouri to be added to the Special Exposure Cohort (SEC).
The decision to initiate this petition occurred after the National Institute for Occupational Safety and Health (NIOSH) determined that it could not reconstruct a radiation dose under 42 C.F.R. § 83.14. NIOSH submitted its findings to the petitioners and the Advisory Board on Radiation and Worker Health (“the Board”). On December 18, 2008, the Board submitted recommendations to the Secretary of Health and Human Services (HHS) to add to the SEC a class of employees who worked at the Mallinckrodt Chemical Company, Destrehan Street Plant in St. Louis, Missouri.
On January 16, 2009, the Secretary of HHS designated the following class for addition to the SEC in a report to Congress.
All employees of DOE, its predecessor agencies, and their contractors and subcontractors who worked in the Uranium Division at the Mallinckrodt Chemical Co., Destrehan Street Plant in St. Louis, Missouri, from January 1, 1958 to December 31, 1958, for a number of work days aggregating at least 250 work days, occurring either solely under this employment or in combination with work days within the parameters established for one or more other classes of employees included in the SEC.
A copy of the Secretary’s letter to Congress recommending the designation is included as Attachment 1. The SEC designation for this class became effective as of February 15 , 2009, which was 30 days after the Secretary of HHS designated the class for addition to the SEC in a report to Congress. Although Congress had the authority to reject the recommendation within the 30-day time frame, Congress took no action and therefore the new SEC class became effective February 15 , 2009.
While a new SEC class has been added for employees at Mallinckrodt, NIOSH has determined that it is likely feasible to reconstruct both individual external dose and occupational medical dose for Mallinckrodt workers with sufficient accuracy. NIOSH also intends to use any available internal and external monitoring data that may be available for an individual claim (and can be interpreted using existing NIOSH dose reconstruction processes or procedures). This means that for claims that do not satisfy the SEC criteria, a partial dose reconstruction is to be performed by NIOSH.
This is the third SEC class in effect for Mallinckrodt. Two previous classes for workers at Mallinckrodt during the combined periods of 1942-1957 were the subject of DEEOIC Bulletins 06-03 and 06-05.
References: Energy Employees Occupational Illness Compensation Program Act of 2000, 42 U.S.C. § 7384 et seq.; 42 C.F.R. Part 83, Procedures for Designating Classes of Employees as Members of the Special Exposure Cohort Under EEOICPA; the January 16, 2009 letter to Congress from the Secretary of HHS in which Secretary Leavitt makes the designation.
Purpose: To provide procedures for processing SEC claims for workers at the Mallinckrodt Chemical Company, Destrehan Street Plant in St. Louis, Missouri.
Applicability: All staff.
Actions:
1. This class encompasses claims already denied, claims at NIOSH for dose reconstruction, and future claims yet to be submitted.
2. The Division of Energy Employees Occupational Illness Compensation (DEEOIC) has prepared a list of cases with claimed employment at Mallinckrodt during the period of the SEC class. It includes pending cases, cases previously denied, and cases at NIOSH. It also includes specified and non-specified cancer cases. All cases on this comprehensive list must be reviewed by the district office(s) and by the Final Adjudication Branch (FAB) to determine whether the SEC class criteria are satisfied. This comprehensive list will be provided to the appropriate district offices and FAB under separate cover.
3. The district offices are to use the comprehensive list as the basis for an initial screening of cases associated with this Bulletin. The purpose of the screening is to make an initial determination on whether a case is likely to meet the criteria for inclusion into the SEC class. A screening worksheet is included as Attachment 2. The worksheet must be completed for all cases on the comprehensive list. Upon completion, the worksheet is to be included in the case record. Based upon the initial screening, the cases on the list will be grouped into three categories: those likely to be included in the SEC class; those not likely to be included in the SEC class; and those for which development may be needed to determine whether the case can be accepted into the new SEC class. New claim status codes have been created in ECMS to reflect each of these categories: ISL (Initial SEC Screening, Likely SEC) for those likely to be included in the SEC class; ISU (Initial SEC Screening, Unlikely SEC) for those unlikely to be included in the class; and ISD (Initial SEC Screening, Development Needed), for which development may be needed in order to reach a determination on SEC class inclusion. A reason code had also been created, in this instance, 909 (Reviewed under Bulletin 09-09, Mallinckrodt 1958 SEC class). Once the worksheet is completed, the claims examiner (CE) is to select the appropriate claim status code and associated reason code from the drop down lists in ECMS B only. The status effective date for the ISL, ISU and ISD codes is to correspond with the completion date of the screening worksheet.
The purpose of this initial screening is to assist the district offices in prioritizing claims posed for acceptance and for purposes of meeting the FY 2009 operational plan goal. Once screening and prioritization is complete, claims adjudication proceeds in the usual manner. No matter the outcome of the screening protocol, each case must be evaluated formally for SEC inclusion and the decision recorded in ECMS. This screening step is only applicable to cases on the comprehensive list. It is not applicable to new claims submitted after the list is generated. These claims will be evaluated for inclusion in the SEC in the general course of processing.
4. For cases on the comprehensive list at FAB, the designated CE2 Unit is to conduct the initial screening, worksheet and related coding.
5. The comprehensive list includes cases identified by NIOSH that should be considered for inclusion in the SEC class. NIOSH will return dose reconstruction analysis records for cases with specified cancers to the appropriate district office along with a CD for each case. The CD should contain all of the information generated to date, e.g., CATI report, correspondence, and dose information. Also included on the CD in the Correspondence Folder, should be a copy of the NIOSH letter sent to each claimant informing the claimant of the new SEC class and that his or her case is being returned to DOL for adjudication. A copy of the NIOSH letter to affected MCW claimants is included as Attachment 3. The CE must print out a hard copy of the NIOSH letter for inclusion in the case file.
Once a case file is returned from NIOSH (including those cases that DEEOIC has withdrawn from NIOSH) to the district office for potential inclusion in the SEC class, the CE enters status code “NW” (NIOSH, returned without a dose reconstruction) in ECMS B. The status effective date for the code entry is February 17 , 2009. However, the CE does not enter the status code until the DEEOIC office actually receives the NIOSH-returned dose reconstruction record. The standard procedure for NIOSH coding in ECMS E is to code all additional NIOSH actions only if the “NI” (Sent to NIOSH) status code has been entered. Therefore, the CE enters the “NW” code into ECMS E with the status effective date of February 17, 2009 only if “NI” (Sent to NIOSH) has already been entered in ECMS E.
Although this class becomes effective on February 15, 2009, because that is a Sunday and the following day is a holiday, the Bulletin effective date is February 17, 2009. It is the Bulletin date that forms the basis for the ECMS status effective date coding, February 17, 2009.
There may be some cases on the comprehensive list that were not identified by NIOSH for potential inclusion in the SEC and consequently are still at NIOSH for a dose reconstruction. These cases must also be evaluated for inclusion in the SEC class in accordance with the procedures in this bulletin. If any such case qualifies under the SEC class, the CE, through the Senior CE (SrCe), notifies the appropriate point of contact at NIOSH via e-mail to return dose reconstruction analysis records. The SrCE then prints a copy of the “sent” e-mail (making sure the printed copy documents the date it was sent) for inclusion in the case file. The CE is to enter status code “NW” with the status effective date of February 17, 2009. In addition, the CE must write a letter to the claimant to advise that the case file has been withdrawn from NIOSH for evaluation under the SEC provision.
If the case is still at NIOSH and does not qualify under this SEC provision, based on the guidance provided in this bulletin, then refer to instructions in Action #16.
6. For any cases identified as having a potential for compensability based on the new SEC class, the responsible CE is to review all relevant documentation contained in the case file, including any documentation that NIOSH may have acquired or generated during the dose reconstruction process.
7. Based on this review, the CE determines whether the employee has a specified cancer, as listed in the Federal (EEOICPA) Procedure Manual (PM) Chapter 2-600.5. If the employee has a specified cancer, proceed to Action #8. If the employee does not have a specified cancer, proceed to Action #10.
8. If the employee has a specified cancer, the CE must verify the employee worked in the Uranium Division of Mallinckrodt at the Destrehan Street facility. The term “Uranium Division” includes work performed at any building, structure, or premise that is owned by the Mallinckrodt Chemical Company located within the area bounded in part by North Broadway, Angelroot Street, and Salisbury Street.
If the employee meets this criterion, the CE must determine whether the worker was employed at least 250 work days at Mallinckrodt between January 1, 1958 and December 31, 1958. The CE may refer to EEOICPA Bulletin No. 02-09 for guidance on calculating 250 work days.
HHS has previously designated SEC classes for employment at Mallinckrodt during the periods 1942-1948 and 1949-1957. Based on available information, NIOSH has concluded that similar operations and radiological exposure conditions upon which the 1949-1957 SEC class is based continued into 1958. NIOSH has found no substantive difference in site operations, personnel and workplace monitoring, source term, or available site characterization data between 1958 and the previously designated 1949-1957 SEC period. As a result, NIOSH assumes that the potential for radiation exposure existed in all buildings and areas within the Uranium Division. Additionally, as with the earlier SEC periods, NIOSH does not have sufficient information for 1958 to distinguish the raffinate-exposed workers from the workers who never worked with raffinate. Therefore, NIOSH is unable to define potential radiation exposure conditions based on worker job descriptions, job titles and/or job assignments within the Uranium Division. Based on the SEC designation, any probative evidence that the employee was employed at Mallinckrodt’s Uranium Division for at least 250 work days during the SEC period is sufficient to include him or her in the SEC class.
If the employee does not have 250 days at Mallinckrodt, the CE should review the file to determine if additional days in the SEC can be found by combining days from employment that meets the criteria for other classes in the SEC and aggregating them together to meet the 250-work-day requirement. If after such review the employee still does not meet the employment criteria, proceed to Action #10.
9. Once the CE has determined the employee has a diagnosed specified cancer and meets the employment criteria of the SEC class, the CE proceeds in the usual manner for a compensable SEC claim and prepares a recommended decision.
ECMS Coding Reminder: The “SE” (Confirmed as SEC Claim) status code must be entered into ECMS B with a status effective date equal to the status effective date of the recommended decision to approve. If the case is an E/B case, and the basis for the Part E acceptance is the Part B SEC acceptance, the “SE” code must also be entered into ECMS E with a status effective date of the recommended decision to approve under Part E.
For all claims where Mallinckrodt employment is claimed, regardless of whether the SEC criteria are met, the SEC site code must be entered under the “SEC/SEC Desc” field on the claim screen. The SEC site code for the Mallinckrodt Chemical Company, Destrehan St. Plant in St. Louis, Missouri is 0029.
10. As discussed earlier, although HHS determined that it is not feasible for NIOSH to perform complete dose reconstructions for this class of employees, NIOSH has indicated that partial dose reconstructions are possible. Accordingly, for cases that had not been submitted to NIOSH and do not meet the criteria of the SEC class, the CE must refer these cases to NIOSH with a NIOSH Referral Summary Document (NRSD) to perform dose reconstructions. The CE enters status code “NI” in ECMS B. The status effective date is the date of the Senior or Supervisory CE signature on the NRSD. IF the case is an E/B case, the “NI” code is not entered into ECMS until toxic exposure development is complete.
For those cases which were previously submitted to NIOSH for dose reconstruction and which were returned to the district office for consideration for inclusion in this SEC class, a new NRSD is not required. If it is determined that the case does not qualify for the SEC class, the CE, through the SrCe, notifies the appropriate point of contact at NIOSH via e-mail to proceed with the dose reconstruction. The SrCE then prints a copy of the “sent” e-mail (making sure the printed copy documents the date it was sent) for inclusion in the case file. The CE enters status code “NI” into ECMS B, effective the date of the e-mail requesting NIOSH to proceed with dose reconstruction. The e-mail should include a brief statement of 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 is to notify 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 is to send a copy of this letter to NIOSH. If the case is an E/B case and toxic exposure development was completed with a memorandum to file (with a prior “NI”/”NW” code), the CE enters status code “NI” into ECMS E with the status effective date of the e-mail requesting NIOSH to proceed with dose reconstruction.
Upon receipt of the dose reconstruction report, the CE proceeds in the usual manner and prepares a recommended decision. The CE enters status code “NR” (NIOSH Dose Reconstruction Received) in ECMS B and selects the “PD” (Partial Dose Reconstruction) reason code. The status effective date is the date the dose reconstruction is date-stamped into the District Office. The CE should not delete the “NW” (NIOSH, returned without a dose reconstruction) or “NI” code already present in ECMS. If the CE had previously entered “NI” in ECMS E, the CE also enters the status code “NR” and the reason code “PD” into ECMS E. If the case is an E/B case, the CE enters the Probability of Causation (PoC) into ECMS B and ECMS E (regardless of whether the “NI” code had previously been entered).
11. If the claim meets the SEC employment criteria and includes both a specified cancer and a non-specified cancer, medical benefits are only paid for the specified cancer(s), any non-specified cancer(s) that has a dose reconstruction that resulted in a probability of causation of 50 percent or greater, and any secondary cancers that are metastases of a compensable cancer. In these instances, the CE drafts a recommended decision to accept the claim for the specified cancer (provided all criteria are met) and, if necessary, concurrently prepares a NRSD to NIOSH for a dose reconstruction for the non-specified cancer to determine eligibility for medical benefits. The CE enters status code “SE” and the “NI” code into ECMS B. The status effective date for the “SE” code is the date of the recommended decision to accept the specified cancer. The status effective date for the “NI” code is the date of the Senior or Supervisory CE signature on the NRSD. If the case is an E/B case, the CE enters status code “NI” only after the toxic exposure development is complete and the CE cannot accept causation. In that case the CE creates a memorandum to file stating that toxic exposure development is complete. The CE then enters status code “NI” into ECMS E with the date of the memorandum as the status effective date.
12. If there is a final decision to deny based on a POC of less than 50% and a review of the evidence of record establishes likely inclusion in the SEC class, the case will need to be reopened. In the exercise of the Director’s discretion of the reopening process, the Director is delegating limited authority to the four District Directors to sign Director’s Orders for reopening. This delegated authority is limited to reopenings based upon evidence that a Mallinckrodt employee meets the criteria for placement into the Mallinckrodt SEC class as defined by this bulletin. This delegated authority extends to any case potentially affected by this SEC class. However, if the District Director is unsure of whether the SEC is applicable to the case, the case should be referred to the National Office. A sample Director’s Order is provided in Attachment 4. The Director of the DEEOIC is retaining sole signature authority for all other types of reopenings not otherwise delegated. Once a Director’s Order is issued, the district office is responsible for issuing a new recommended decision.
13. For those cases which are reopened under the authority granted in this Bulletin, the District Director enters status code “MN” (NO Initiates Review for Reopening) in ECMS B with a status effective date as the effective date of this bulletin. If the District Director is also reopening Part E, the “MN” code is also input in ECMS E. For all reopenings per this bulletin, upon completing the Director’s Order to reopen the claim, the District Director (DD) enters status code “MD” (Claim Reopened – File Returned to DO) into ECMS B and/or ECMS E to reflect that the case has been reopened and is in the district office’s jurisdiction. (The “MZ” status code is not necessary). The status effective date of the “MD” code is the date of the Director’s Order. Please note that while the “MD” code is generally input by National Office staff, entry of this code has been delegated to the District Director, just as the authority to grant reopenings has been in this specific circumstance.
14. Upon issuance of this Bulletin, FAB personnel must be vigilant for any pending Mallinckrodt cases that have a recommended decision to deny. All cases on the comprehensive list identified in action item 2 that are located at a FAB office must be reviewed for possible inclusion in the SEC class. If the employee worked at Mallinckrodt during the time period specified, has a specified cancer, and meets the 250-work-day requirement, the FAB is to reverse the district office’s recommended decision to deny and accept the case. The CE or FAB staff person enters status code “F6” (FAB Reversed to Accept) into ECMS B/E with appropriate reason code (as appropriate) to reflect the FAB reversal with a status effective date equal to the date of the final decision to approve. The CE or FAB staff person enters status code “SE” into ECMS B with a status effective date equal to the date of the final decision to approve. If the FAB is also reversing the Part E decision based on SEC designation, CE or FAB staff person also enters status codes “F6” and “SE” into ECMS E with a status effective date of the final decision for Part E.
If no action is required, FAB must follow the instructions specified in action item 16, below, to indicate that a review of the case was completed.
Every effort should be taken to avoid a remand of a potential SEC claim to the District Office. If FAB determines that the case cannot be approved based on the new SEC designation and that re-referral to NIOSH is appropriate (see action items 7, 8 and 10) the CE or FAB staff person must remand the case for district office action. The CE or FAB staff person enters status code “F7” (FAB Remanded) with “OTH” (No DO Error – Other) as the reason code. If the Part B and/or E decision is being remanded, the CE or FAB staff person enters the remand code into ECMS B with a status effective date of the date of the remand.
15. The operational plan goal for completion of the action items in the Bulletin is as follows: The initial screening is to be complete for 90% of all cases on the comprehensive list within 30 days of the Bulletin effective date. Recommended decisions are to be issued 45 days after the initial screening for 60% of those cases that are identified via initial screening as likely to be included in the SEC class (ISL) and those for which development may be needed (ISD). Recommended decisions are to be issued 60 days after the initial screening for 90% of those cases that are identified via initial screening as likely to be included in the SEC class (ISL) and those for which development may be needed (ISD).
16. If, after review or further development, the CE or FAB staff person determines that a case on the list does not require any action, the CE or FAB staff person must write a brief memo to the file indicating that the file was reviewed and noting the reason why no additional action is necessary, and why. A case classified as not requiring any action is a case that does not meet the SEC criteria and there is no need to return it to NIOSH for partial dose reconstruction.
The CE must then code “NA” (No Action Necessary) and then select the appropriate reason code from the reason code drop down list. The “NA” coding is specifically tied to the SEC review list generated by DEEOIC and the “NA” code is restricted to ECMS B only because the SEC review list is derived from Part B data. For Mallinckrodt cases that were reviewed under this bulletin and require no additional action, the reason code that must be selected is “909” and be coded into ECMS B only. Even if the case is an E/B case, the “NA-909” must be coded into ECMS B only. The status effective date of the “NA” code is the date of the memo to the file stating review is complete and the CE has determined there is no further action necessary. For those instances in which further development is necessary, the “NA-909” code is not entered initially. The “NA-909” code is only entered when the CE determines after development that the case does not meet the SEC criteria or there is no need to return it to NIOSH for partial dose reconstruction. For those cases on the DEEOIC list that were not withdrawn from NIOSH, the CE enters the “NA-909” code only after the CE determines that the case does not meet the SEC criteria. These cases remain at NIOSH for completion of a partial dose reconstruction.
Please note that if the CE discovers that the claimant(s) is/are deceased, the CE must still enter the “NA-909” code in addition to the closure code. The status effective date for the “NA” coding is the date of the memorandum to file.
Disposition: Retain until incorporated in the Federal (EEOICPA) Procedure Manual.
RACHEL P. LEITON
Director, Division of Energy Employees
Occupational Illness Compensation
Distribution List No. 1: Claims Examiners, Supervisory Claims Examiners, Technical Assistants, Customer Service Representatives, Fiscal Officers, FAB District Managers, Operation Chiefs, Hearing Representatives, Resource Centers and District Office Mail & File Sections.