Committee on Review of the Department of Labor s Site Exposure Matrix (SEM) Database

Transcription

1 Committee on Review of the Department of Labor s Site Exposure Matrix (SEM) Database Questions for DOL: 1. What is the difference between a bulletin and a circular? Both documents serve as vehicles for issuing policy guidance. A bulletin communicates specific, step-by-step instructions. A circular communicates general programmatic information, such as how a child is defined under the Act. What prompts the creation of a policy bulletin? How is a bulletin developed, reviewed, and issued? A bulletin is created in response to some claim situation that is not already addressed in the Procedure Manual. Management will meet and discuss the issue. Once an outline of a path forward is determined, an analyst will be assigned to write the Bulletin. The draft is then circulated within DEEOIC (and sometimes our agency partners as well) offering multiple opportunities for comment, edit and revision. Once the concurrence process is completed, the Bulletin is issued. As the program becomes more mature, we anticipate fewer policy bulletins. Ultimately all procedural guidance provided in Bulletins is incorporated into the Procedural Manual. 2. As SEM is monitored and updated by Paragon are changes to the SEM applied retrospectively to initiate a review of previously denied claims? How does EEOICPA BULLETIN NO Issue Date: June 14, 2010-play a role? The adjudication-related change report outlined in Bulletin No is used regularly in the processing of Part E claims. The routine ways this report is used is represented in the flowchart in response to Question #7. However, the report is used far more broadly than as noted in the flow chart. Any time a case is reviewed, whether for a reopening request, a new claimed condition, or some other reason, this report is run to check if a SEM update affects the Part E claim in a material way. Additionally, project teams have systematically reviewed cases after significant updates in SEM, particularly lung conditions and Parkinsons. Bulletin No also provides for the Post- Adjudication Report, which was initiated and is available, though we are in the process of updating how systematic reviews are accomplished.

2 3. Does DOL keep track of the diseases and potential exposures for denied claims? Is there a database? Is there any evaluation of denied claims to identify clusters of diseases, exposures, or site information to show where the SEM might be missing information? DEEOIC has an extensive claims database, recently improved and updated in January While review of the claims tracking database is outside the scope of the IOM committee review, some information about the claims tracking mechanism may be helpful to you. Diseases claimed, accepted and denied are all tracked. We can, for example, compile a list of diseases denied under Part E, including how many cases associated with that ICD-9 code are denied and how many are approved. The list would not, however, provide a reason for the denial it could be that the medical information was insufficient to support the diagnosis, it can be that the Part E causation standard was not met or any number of reasons. In the past, as SEM was still relatively new, DEEOIC conducted reviews of denied claims, particularly lung conditions as described above, to determine whether or not the addition of disease causing agents and the condition of COPD altered the original adjudicatory posture. Of 1,859 cases reviewed, only 6% resulted in acceptances due to the addition of new information. In addition to the pre/post-adjudication reports described above, DEEOIC will continue to track new diseases and the addition of significant new exposure information to determine whether or not past adjudicatory actions require further review in the light of new SEM information.

3 4. How are co-occurring exposures handled if it possibly contributes to an EEOICPA exposure? (i.e. smoking) how and who determines this? SEM handles all exposures individually and is not designed to gauge the effect of co-occuring exposures. In general, the concept of synergistic/additive effect is not widely accepted in the scientific literature, and for this reason, DEEOIC also does not recognize synergistic/additive effects per se. Specific analysis of exposure/disease relationships are, however, handled on a case-by case basis and that project falls largely out of the scope of this review. However, for your information, the process by which smoking history is addressed can be found in the District Medical Consultant (DMC) Handbook on page 15, which states: b. Smoking and Workplace Exposures. A history of smoking does not negate the role of workplace exposures in making a supportive determination. The American Thoracic Society (ATS) statement on the Occupational Contribution to the Burden of Airway Disease (2003) notes: Despite the difficulty of disentangling the effects of cigarette smoke from those of other exposures, an increasingly impressive body of scientific literature is available demonstrating that specific occupational exposures contribute to the development of COPD (p. 788). 1 Overall, the magnitude of effect of occupational exposures appears consistent with that of cigarette smoking (p. 788). 2 Henrick notes (Thorax, 1996) that only 15-20% of smokers actually develop COPD. There is evidence, however, that when smokers additionally work with noxious respirable agents, COPD occurs with unusual frequency and/or severity. This indicates interaction between smoking and working environment. 3 Additionally it is understood that individual physicians will apply this guidance differently, but in the event of a conflict with policy or a conflict between physician opinions, another referral or even a referee medical opinion can be obtained. Again, please note that this is for informational purposes only. Evaluating the development process after SEM is not part of the committee s charge. 1 ATS: American Thoracic Society Statement: Occupational Contribution to the Burden of Airway Disease. Am J Resp Care Med 167: Found at 2 ATS: American Thoracic Society Statement: Occupational Contribution to the Burden of Airway Disease. Am J Resp Care Med 167: Found at 3 Hendrick DJ. Occupation and chronic obstructive pulmonary disease (COPD). Thorax 51:

4 5. What is the method used to determine if disease risk from an occupational exposure is at least as likely as not a significant factor in aggravating, contributing to, or causing the illness? This type of assessment occurs outside the SEM and is handled by an assessment of the medical evidence, provided by either the employee s personal physician or via a referral to a medical consultant. Determining how DEEOIC renders interpretations of the statutorily imposed causative burden is not part of the committee charge. However, for context and informational purposes, the discussion below outlines the general process. There is some specific guidance for some of the more common diagnoses, which can be found in Chapter , Exhibit 2, Matrix for Confirming Sufficient Evidence of Non-Cancerous Covered Illnesses and in Bulletin 06-13, Establishing causation for specific medical conditions under the Energy Employees Occupational Illness Compensation Program Act (EEOICPA). However, there is always the possibility that diseases can be accepted with less stringent standards through a finding that toxic exposure was at least as likely as not a significant factor in aggravating, contributing to, or causing the illness. There are no specific rules for making such a determination, but rather generalized guidance on making sound decisions on a case-by-case basis, which ultimately is based upon medical opinions in the file. Some language that describes in general terms what should be included in such a determination is in Chapter , as part of weighing the medical evidence, because ultimately this really is a medical determination. There are many individual factors, such as latency periods, length and duration of exposure, and other potential predispositions that must be weighed by a medical professional, such as the treating physician or a medical consultant. This intricate and painstaking process falls well outside the realm of SEM. 6. How is radiation currently factored into risk assessment for Part E claims? Any cancer claims accepted under Part B, whether the result of a dose reconstruction or inclusion in a class of employees in the Special Exposure Cohort, are automatically accepted under Part E. Circular outlines scientifically established ionizing radiation health effects under Part E and discusses the specific situations whereby 3 conditions (cataracts, aplastic anemia, and acute radiation sickness) can be potentially accepted under Part E. 7. Can you provide a diagram/flowchart for the claims adjudication process for a Part E claim and integration of SEM? Under construction. 8. What is the role of the EEOICPA epidemiologist, toxicologist, and occupational medicine doctor in the Part E Review Process? Do reviews by the EEOICPA epidemiologist, toxicologist, and/or occupational medicine doctor of claims trigger changes in the SEM? For instance, when trends are observed, or inconsistent, inaccurate or missing data is discovered by any of them is feedback provided to Paragon or Jay Brown for further research and possible inclusion in the SEM?

5 The epidemiologist/toxicologist assists the DEEOIC by reviewing and evaluating journal articles or literature. These publications are reviewed along with the body of scientific literature and a decision is made by the epidemiologist/toxicologist regarding any causal association using known principles of causality (i.e., strength of an association, consistency of an association, biologic plausibility etc.). Journal articles or literature are submitted either in relation to a specific case file or for general consideration. All such materials deemed worthy of concurrent or further review by Dr. Jay Brown are forwarded to him for evaluation. Dr. Brown makes his own determination as to whether or not these materials warrant inclusion into Haz-Map. The DEEOIC Medical Director is also often involved in the evaluation of journal articles and literature concurrent with the toxicologist review and renders his/her own opinion as to the scientific validity of the materials in question. In some instances, such as the recent guidance regarding hearing loss promulgated in DEEOIC, research conducted by the toxicologist/medical Director is utilized to formulate policy guidance to expedite claim acceptances. These actions are outside of the SEM process, but demonstrate program dedication to utilizing tools outside of SEM when conducting claim development. What is the role of the EEOICPA occupational medicine doctor in the Part E Review Process? Although the role of the medical consultants is beyond the scope of this review, it can be helpful to understand their role in the context of Part E. The physicians assist the DEEOIC by reviewing and evaluating the medical evidence of record and providing medical opinions regarding various aspects of selected compensation cases. In order to better respond to the wide variety of medical issues that arise in this program, we have many different medical specialists available to us under one contractor with oversight by the DEEOIC Medical Director. These physicians do not review every case, rather claims examiners (CEs) seek medical input from physicians in selected cases. Such input may include: Causality issues involving the work relatedness of a given disease, whether exposure to particular toxic substances at work caused, contributed or aggravated the disease, the role of the covered illness in the death of a claimant; the appearance of secondary or consequential diseases or injuries, etc. The explanation of treatment modalities, the interpretation of clinical test results, assistance with establishing or confirming a diagnosis and the clarification of other physicians reports. Determining the level of impairment in a given case in accordance with the American Medical Association s Guides to the Evaluation of Permanent Impairment (5th edition is currently in use by the Program) and the Handbook. Assessing an individual s ability to work during a given time period, as it relates to the covered condition. The medical opinion should be provided by a qualified physician with expertise in treating, diagnosing or researching the illness claimed to be caused or aggravated by the alleged exposure. The physicians medical reports are evidence that enable the program s CEs to reach adjudication decisions regarding causality, impairment or wage loss in compensation cases.

6 Do reviews by the EEOICPA epidemiologist, toxicologist, and/or occupational medicine doctor of claims trigger changes in the SEM? For instance, when trends are observed, or inconsistent, inaccurate or missing data is discovered by any of them is feedback provided to Paragon or Jay Brown for further research and possible inclusion in the SEM? DEEOIC staff decisions do not alter the causation links in Haz-Map, but there is a feedback loop by which this type of documentation can affect DEEOIC policy guidance. The recent change regarding solvent-induced hearing loss, noted in # 8 above, is an example of such an instance. Also, as noted in # 8 above, journal articles and other findings are routinely shared with Dr. Jay Brown for consideration to determine their value to Haz-Map. Dr. Brown s deliberative process is independent of DEEOIC, but routine conference calls and other communications exist between Dr. Brown and DEEOIC to transmit new scientific findings of interest. 9. How does evidence disseminate through DOL for incorporation into the SEM from approved claims using information not currently supported by the SEM? As claims are sent in to the national office for review by an industrial hygienist, toxicologist or other policy review, journal article type documents are reviewed and a number of things can happen as a result. In instances in which there is some causal link found, then policy guidance can be issued. If instances in which the submission is not compelling, then the case can be returned to the district office and no further policy action taken. If, on the other hand, a case is approved at the district office level based almost entirely on the statements of a treating physician and FAB likewise affirms the finding, there is no feedback to SEM, because those are seen as individual, casespecific determinations that do not necessarily apply program-wide. 10. Are Risk Assessment Documents used or factored in the claims process (i.e. Superfund Risk Assessment)? Any document can be submitted as part of the claims process. If there is a Superfund document pertinent to a DOE facility that identifies some chemical or toxin, then that could be submitted to DEEOIC for consideration and/or Paragon for potential inclusion into SEM. Paragon will then research the substance, try to obtain confirmation from DOE as to the use of the substance at DOE, including identification of work processes associated with the toxin and locations of its use. Once that is completed, it can be added to SEM. This is the standard review process for submissions of additional chemicals to SEM. There is no specific process associated with Superfund Risk Assessment documents. 11. Is a worker assumed to be exposed if only one of the listing applies (building, job title, and process), or conversely, is a worker required to match all three categories? Only one match is required, but every possible potential category is searched by the CE.

7 12. Who sits on the DOL s internal Site Exposure Matrix Review Committee and what do they do? There are regular and periodic meetings between the DEEOIC Medical Health Sciences Unit Staff, a DEEOIC policy analyst, Paragon and Dr. Brown. During these teleconferences updates and priorities are discussed. 13. Where and how are studies of DOE workers, such as mortality studies in DOE cohorts and the Former and Current Worker Program medical surveillance data, incorporated into the SEM or Haz-Map? The SEM team reviewed the 20 years of epidemiological and mortality-type studies based on DOE workers that preceded EEOICPA. In reviewing this 20-year pre-eeoicpa set of materials, however, it is noteworthy that most of these studies focused on the relationship between radiation and cancer. However, for those few studies not focused on radiation, the SEM team did acquire copies. Additionally, the SEM team acquired copies and reviewed all of the Former Worker Program Needs Assessment documents. With regard to use of the material, one study, Mercury Releases from Lithium Enrichment at the Oak Ridge Y-12 Plant a Reconstruction of Historical Releases and Off-Site Doses and Health Risks, (January 7, 1999) showed that mercury was an identifiable health hazard. The use of mercury is reflected in SEM based on the information found in this report, including any applicable buildings, locations and job categories. In SEM, mercury is linked to chronic renal failure, contact urticaria, chronic toxic effect of elemental mercury, toxic neuropathy and toxic pneumonitis. One factor that limits the utility of these studies is the fact that they don t necessarily apply to the individual. Specifically, even though mercury is a known health hazard in Oak Ridge, it does not logically follow that everyone who worked there was either exposed to mercury or experienced a health hazard as a result. Additionally, any claimant can submit any type of study at any time as part of their claim or directly to the SEM team via their website. All submissions as part of the claim will be evaluated in the fact-specific context of that claim and submissions to SEM will be reviewed by the SEM team. In terms of the medical surveillance data specific to the employee, this documentation is gathered, reviewed and considered as part of the entire case file. Most of the medical surveillance data does not link specific toxic substance exposure to health conditions. DOL does, however, share information with the SEM team when that documentation discusses such links.

8 Questions for Jay Brown: 1. What are your criteria for determining causality? For cancer outcomes? For non-cancer outcomes? (examples, strong versus convincing, IARC categories?) 2. What are the criteria for determining that there is no causal link to an occupational exposure or more research is needed? What is difference between blue, yellow, and red highlighted diseases from your handout? 3. How do you select new chemicals or diseases to review? 4. How often do you update diseases and chemicals? How do you select those to update? If a decision is made not to link a chemical with a disease, when is the decision reexamined? 5. When using individual studies for information, how do you assess the study s quality (study type, bias, sample size, etc)? 6. How do you use animal and epidemiological data and how is it included or weighted into causal decisions? 7. What are your criteria for picking resources? The reference list is long and varied, with many different purposes and methodology. 8. Who reviews your data entry and data extraction and who verifies the information as accurate? 9. How is new information in new textbook additions identified? 10. What do you submit to NLM, do they review/verify the content? If so, what is the process? 11. What is NLM s Role in Haz-Map? Questions for Paragon: 1. There are ~12,000 chemicals in SEM and only ~6,000 in Haz-Map; how do you address chemicals not in Haz-Map? Do you prioritize chemicals for Jay Brown to research for addition to Haz-Map? 2. Does Paragon do QA/QC for information in Haz-Map, if so what are those procedures? 3. Are there external reviewers that periodically audit the SEM development and maintenance process? 4. Is there a minimum concentration or duration required for listing a chemical in the SEM? 5. What data/information must a claimant/public submissions show for submission for a chemical to be considered for inclusion in the SEM? 6. Can you provide a mapping for the relational database? 7. Does Paragon become involved in individual cases at any point? E.g. if a co-worker or a patient s physician says that a chemical was present at a particular plant, do you evaluate if this is true? Does Paragon receive information from Claim s Examiners records of chemicals alleged to be present in facilities?