Progress Report of Part B Lung Conditions Subcommittee

Progress report detailing the activities of the Part B Lung Conditions Subcommittee from initial advisory board meetings to defining data needs, reviewing data analysis, and addressing questions and comments from the Department of Labor related to lung conditions including Chronic Beryllium Disease (CBD) and Beryllium Sensitization (BeS). The subcommittee aims to gather relevant data, review cases, and make conclusions and recommendations based on their findings.

• Progress report
• Part B Lung Conditions Subcommittee
• Advisory Board
• Data analysis
• Chronic Beryllium Disease

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1. Advisory Board on Toxic Substances and Worker Health: Part B lung Conditions Subcommittee Chair Carrie A. Redlich, MD, MPH Members John M. Dement, PhD, CIH Kirk D. Domina, Hanford Atomic Metal Trades Council James H. Turner, Rocky Flats Nuclear Weapons Facility Laura S. Welch, MD

2. Part B lung Conditions Subcommittee Progress-to-Date Initial Advisory Board Meeting (April 26-8, 2016) Subcommittee Teleconferences, Public June 29, 2016 Clarify Part B subcommittee charge Define data and information needs September 21, 2016 Review initial data analysis Plan for review cases

3. Part B Subcommittee: Progress-to-Date 1) Clarification goals 2) Request to DOL for information: 3) DOL response 4) Analysis data (Dr. Dement) 5) Initial review cases 5) Initial conclusions / recommendations

4. Part B Subcommittee: Comments / Questions from DOL 1) BS / BeLPT / medical monitoring 2) Diagnostic criteria CBD 3) Sarcoidosis vs CBD 4) Silicosis 5) Complications of disease / treatment Other issues ?

5. Part B Subcommittee: Information Needs 1) Data on Part B claims process, outcomes 2) Cases to review BS, CBD, CS, Sarcoid, ILD 3) Relevant surveillance / other data from Hanford, US military, other worksites 4) Input from patients, providers

6. 5/4/16 Sub-committee Lung Disease - Part B DATA REQUEST (understanding not all may be available) I. Claims Data All data preferred both annually and total to-date so can see trends. We recognize annual data may be challenging to obtain, given the many years of claims and the data collected and claims process has likely changed over time, so annual data for the most recent years (eg 3-5 yrs) is the most important annual data. Need to define Annually = new claim vs re-evaluation of old claim. 1) Chronic Beryllium Disease (CBD) claims submitted under Part B A) # claims submitted total and annually, B) if claim accepted, rejected, no decision yet, reason claim rejected, average time process claim - from time submitted until final decision. C) Worker site, job title for claim D) If claim submitted by survivor vs employee E) if claim - more IH info (SEM) was requested AND comparison of claims where more IH info requested vs not (% accepted, time to decision) F) Comparison of CBD claims that use the pre-1993 vs post-1993 diagnostic criteria for CBD. (we recognize claim can be filed post-1993 criteria but use pre-1993 criteria). Same info as above, would start with # Claims for each, % accepted. 2) Beryllium Sensitization (BeS) claims submitted under Part B Same info as above, absent the pre/post 1993 criteria Also the number of BeS claims eventually accepted for CBD. 3) Silicosis claims submitted under Part B Same info as above, absent the pre/post 1993 criteria Assuming fewer claims - may want to group by several years vs annually. 4) CBD, Silicosis claims submitted under Part E. (Are there any BeS claims submitted under Part E?) We suspect fewer of these. Same info as above. 5) Chest x-ray B readings Number of B readings submitted yearly - on new claimants vs those already in program, for what diagnoses (assume mostly silicosis). How many also have chest CT scan results and pulmonary function testing? 6) Data on Sarcoid / sarcoidosis claims - for Part B and Part E Same info as above. Are there any under Part B? 7) Data on other non-cancer respiratory conditions - most common diagnoses - eg COPD, Asthma, Interstitial lung disease for Part E and ? Part B. If the only non-cancer respiratory claims under Part B are CBD, BeS and silicosis, then this request relates only to Part E. Same info as above 8) Data on claims for conditions associated with and/ or complications of Part B lung conditions (CBD, Silicosis) - such as osteoporosis, HTN, pulmonary hypertension, diabetes Most common associated conditions, % claims accepted. Most common claim diagnoses to have associated conditions 9) Same data that has been supplied to EECAP 10) Other information: 1. Examples of problem cases - eg denied CBD claims, claims repeat CBD testing, claims that took a long time to resolve, claims where more IH info requested, BeS claims 2. Examples of forms, questionnaires used, communications to physicians, claimants After the subcommittee reviews the above data, it is anticipated that clarification and/or more data may be requested.

8. OVERALL APPROVALS FOR PART B AND PART E CONDITIONS Part B Summary, October 2016 Data Percent Approved 45.73% 59.24% 76.63% Disease Class CBD Be Sensitivity Chronic Silicosis Filed 6029 5561 4234 Approved 2455 3052 2840 Denied 2913 2100 866 Pending 661 409 528 Part E Summary, October 2016 Data Percent Approved 41.34% 63.57% 71.18% 41.65% 48.91% 28.86% 41.08% Disease Class CBD Be Sensitivity Chronic Silicosis Asthma COPD Interstitial Lung Disease Sarcoidosis Filed 4070 4051 3669 2303 7340 953 216 Approved 1463 2345 2304 810 2778 230 76 Denied 2076 1344 933 1135 2902 567 109 Pending 531 362 432 358 1350 156 31

9. PART B APPROVAL RATES FOR CASES WITH SINGLE CONDITIONS FILED, 2005-2016 Part B Approval Rates by Calendar Year CBD_Status_B 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 Overall Approved 135 82 75 43 26 Denied 262 171 229 114 78 Total 397 253 304 157 104 34.0 % % % % % 37 61 98 37.8 % 39 116 155 25.2 % 27 79 106 25.5 % 19 85 104 12 65 77 15.6 % 14 51 65 6 1448 2077 3525 34 40 32.4 24.7 27.4 25.0 Percent Approved 18.3% 21.5% 15.0% 41.1% BS_Status_B 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 Overall Approved 74 90 190 163 108 125 Denied 168 102 109 82 47 48 242 192 299 245 155 173 30.6 % % % % % % 132 46 178 74.2 % 98 47 145 67.6 % 60 31 91 77 31 108 71.3 % 94 40 134 69 26 95 1990 1447 3437 Total 46.9 63.5 66.5 69.7 72.3 Percent Approved 65.9% 70.1% 72.6% 57.9% CS_Approved_B 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 Overall Approved 290 259 594 292 233 179 Denied 30 21 44 50 42 29 320 280 638 342 275 208 90.6 % % % % % % 134 35 169 79.3 % 159 21 180 88.3 % 131 20 151 107 20 127 84.3 % 98 26 124 77 8 85 2808 570 3378 Total 92.5 93.1 85.4 84.7 86.1 Percent Approved 86.8% 79.0% 90.6% 83.1%

10. PART E APPROVAL RATES FOR CASES WITH SINGLE CONDITIONS FILED 2005 - 2016 AND OVERALL Part E Approval Rates by Calendar Year CBD 2005 2006 2007 2008 2009 2010 2011 2012 Approved 99 258 97 53 Denied 8 433 334 119 Total 107 691 431 172 %Approved 92.5% 37.3% 22.5% 30.8% 34.6% 24.1%26.4% 22.7% 18.6% 18.4%17.6% 5.0% 33.0% 2013 8 35 43 2014 2015 2016 Overall 7 6 31 28 38 34 36 68 104 14 44 58 23 64 87 10 34 44 1 19 20 612 1245 1857 BS 2005 2006 2007 2008 2009 2010 2011 2012 17 423 212 154 5 239 174 81 22 662 386 235 2013 55 23 78 2014 2015 2016 Overall 66 75 24 32 90 107 Approved Denied Total 96 55 151 107 38 145 122 37 159 84 34 118 55 22 77 1466 811 2277 %Approved 77.3% 63.9% 54.9% 65.5% 63.6% 73.8%76.7% 71.2% 70.5% 73.3%70.1%71.4% 64.4% CS 2005 2006 2007 2008 2009 2010 2011 2012 23 289 633 316 2 63 142 134 25 352 775 450 2013 119 23 142 2014 2015 2016 Overall 85 83 22 24 107 107 Approved Denied Total 199 110 309 129 60 189 86 41 127 120 46 166 62 19 81 2144 696 2840 %Approved 92.0% 82.1% 81.7% 70.2% 64.4% 68.3%67.7% 72.3% 83.8% 79.4%77.6%76.5% 75.5%

11. PART E APPROVAL RATES FOR CASES WITH SINGLE CONDITIONS FILED 2005 - 2016 AND OVERALL Part E Approval Rates by Calendar Year Asthma 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 Overall Approved 3 18 43 53 49 35 Denied 3 34 62 47 50 53 Total 6 52 105 100 99 88 %Approved 50.0% 34.6% 41.0% 53.0%49.5%39.8%40.2%28.3%42.2% 27.7% 10.6%49.5% 37.5% 33 49 82 32 81 113 46 63 109 23 60 83 10 84 94 55 56 111 400 667 1067 COPD 2005 31 15 46 2006 130 86 216 2007 215 150 365 2008 2009 2010 2011 2012 2013 2014 2015 2016 Overall 272 267 197 140 177 192 141 158 179 216 230 279 413 425 376 356 407 471 Approved Denied Total %Approved 67.4% 60.2% 58.9% 65.9%62.8%52.4%39.3%43.5%40.8% 30.2% 31.3%40.2% 47.4% 111 256 367 112 246 358 98 146 244 1943 2152 4095 ILD 2005 14 4 18 2006 18 20 38 2007 20 38 58 2008 2009 2010 2011 2012 2013 2014 2015 2016 Overall 13 6 5 5 9 24 33 27 19 38 37 39 32 24 47 Approved Denied Total %Approved 77.8% 47.4% 34.5% 35.1%15.4%15.6%20.8%19.1%15.1% 27.3% 15.6% 4.8% 25.5% 8 45 53 6 16 22 5 27 32 1 110 321 431 20 21 Sarcoidosis Approved Denied Total %Approved 2005 0 3 3 0.0% 2006 0 3 3 0.0% 2007 0 5 5 0.0% 2008 2009 2010 2011 2012 2013 2014 2015 2016 Overall 0 2 0 0 0 5 0 2 4 4 5 2 2 4 4 0.0% 100% 0.0% 0.0% 0.0% 10.0% 0.0% 11.1% 0.0% 1 9 10 0 6 6 1 8 9 0 8 8 4 58 62 6.5%

12. Part B Denial Reasons by Condition Filed CBD First_Denial__Reason_Code_B Employee not covered Maximum Payable Benefits Met Medical condition not covered Medical information insufficient Negative Causation Result Survivor not eligible BS First_Denial__Reason_Code_B Employee not covered Medical condition not covered Medical information insufficient Negative Causation Result Survivor not eligible CS First_Denial__Reason_Code_B Employee not covered Maximum Payable Benefits Met Medical condition not covered Medical information insufficient Negative Causation Result Survivor not eligible Frequency 138 7 293 1247 305 87 Percent 6.64 0.34 14.11 60.04 14.68 4.19 Frequency 94 258 956 128 11 Percent 6.50 17.83 66.07 8.85 0.76 Frequency 172 17 158 159 40 24 Percent 30.18 2.98 27.72 27.89 7.02 4.21

13. Part E Denial Reasons by Condition Filed CBD First_Denial__Reason_Code_E Employee not covered Maximum Payable Benefits Met Medical condition not covered Medical information insufficient Negative Causation Result Survivor not eligible BS First_Denial__Reason_Code_E Employee not covered Medical condition not covered Medical information insufficient Negative Causation Result Survivor not eligible CS First_Denial__Reason_Code_E Employee not covered Maximum Payable Benefits Met Medical condition not covered Medical information insufficient Negative Causation Result Survivor not eligible Frequency 112 5 29 461 240 398 Percent 9.00 0.40 2.33 37.03 19.28 31.97 Frequency 73 21 535 153 29 Percent 9.00 2.59 65.97 18.87 3.58 Frequency 84 9 15 130 227 231 Percent 12.07 1.29 2.16 18.68 32.61 33.19

14. Part E Denial Reasons by Condition Filed COPD First_Denial__Reason_Code_E Employee not covered Maximum Payable Benefits Met Medical condition not covered Medical information insufficient Negative Causation Result Survivor not eligible ASTHMA First_Denial__Reason_Code_E Employee not covered Maximum Payable Benefits Met Medical condition not covered Medical information insufficient Negative Causation Result Survivor not eligible INTERSTITIAL LUNG DISEASE First_Denial__Reason_Code_E Employee not covered Maximum Payable Benefits Met Medical condition not covered Medical information insufficient Negative Causation Result Survivor not eligible SARCOIDOSIS First_Denial__Reason_Code_E Employee not covered Medical condition not covered Medical information insufficient Negative Causation Result Survivor not eligible Frequency 158 28 18 391 1443 113 Percent 7.34 1.30 0.84 18.17 67.05 5.25 Frequency 28 2 9 180 439 9 Percent 4.20 0.30 1.35 26.99 65.82 1.35 Frequency 15 10 5 57 219 15 Percent 4.67 3.12 1.56 17.76 68.22 4.67 Frequency 3 5 15 33 2 Percent 5.17 8.62 25.86 56.90 3.45

15. Part B Cases Selected for Review CS (Chronic Silicosis) (n=10) BeS (n=20) CBD (n=19) Sarcoid* (n=15) Pneumoconiosis** (n=20) Accepted CR CR LW JD KD JT JD 2792 B, deny E KD 2424 B, deny E CR 2171 B , deny E LW 0783 B, deny E JT JD 2664 B, deny E LW 2261 B, E Denied# Reviewer Accepted Reviewer Accepted Reviewer Accepted Reviewer Accepted Reviewer CR 6098 LW 8652 CR CR 6875 CR 1868 JD JT 6622 JT 9184 KD LW 6390 KD 5187 JT KD 6083 JD 4491 CR JD 5406 CR 3736 LW KT 4885 LW 2874 CR 2008 JD 9778 CR 2018 CR 0862 CR 2434 KD 9659 Denied Denied 6897 (6040) KD 0473 CR 5695 KD CR (3434) JT 6265 JD 0621 CR JD 5995 KD 0187 LW 4939 JT 2973 CR 2128 CR 1618 JT 1867 LW 4047 LW 0699 JT 8808 JT 2829 7486 5734 3133 3061 1150 0216 Denied JD KD CR JT LW 7390 E 6555 CBD 5457 E 2083 CBD 5225 CBD Denied 6486 B, E 5099 B 3655 B 3329 B 3133 B 3061 B, E 0216 B JD 7504 CR JD 4010 1738 2261 0244 KD JT LW KD JD JT JD LW CR KD 6752 5567 5230 2535 2481 2475 2098 4914 1010 0513 CR LW JD JT KD CR JT 4467 B,E 4101 B,E 1738 B,E 1709 B,E 1079 B, accept E 0298 B, accept E 0221 B,E 6464 KD 1294 LW JD = John Dement KD = Kirk Domina CR = Carrie Redlich JT = James Turner LW = Laura Welch *Sarcoid claims primarily CBD **Pneumoconiosis claims are primarily silicosis / miners - not other pneumoconiosis, interstitial lung diseases. # Primarily denied because no accepted RECA (Radiation Exposure Comp Act) claim.

16. Reviewer Initials: ____________ Date: ______________________ REVIEW FORM EEOICPA PART B LUNG CASES Case ID (last 4 only): _____ Date Birth (year only): ____ Main location(State):___ Deceased Yes No DOE Employment /Exposure information: Source Job / Exposure info: OHQ SEM IH RECA Other _____________________________ Main work site(s), job(s); approx # years worked; exposure(s) of concern (Be, silica, other): ___________________________________________________________________ ________________ _________________________________________________________________ __________________ Do you agree with DOL exposure conclusions? Yes No, Why?______________________________ Medical Information: DOE Med surveillance program?(e.g. ORAU, Denver, Building Trades) Yes No Unknown Source medical info, conclusions: Treating physician CMC Other _________________________ Physician / CMC appropriate expertise? Yes No Unclear: ________________________________ Part B Lung Claims Diagnoses (check all applied for): BS CBD Silicosis /pneumoconiosis Sarcoid Other__________________________________ Additional Part E Claims Diagnoses: Sarcoid COPD Pneumoconiosis Other _____________ Other relevant medical information, other possible DOE-related conditions (e.g. asbestos): __________________________________________________________________________ _________ BeLPT: Yes No Lab NJMC ORAU Results: ________________________________________ Chest x-ray B-read: Yes No Results: ________________________________________________ Other relevant testing: (Spirometry, Chest CT scan, Pathology): ________________________________ ___________________________________________________________________ ________________ Criteria used: If CBD: Pre-1993 Post-1993 Sarcoid presumption Unclear/other ____________ Criteria used If other B or E condition: DOL RECA Other/unclear: ________________________ DOL Final B Claim Decision: Accepted Denied Other: _______________________________ DOL E Claim decision: Accepted Denied Remand Other:_____________________________ ___________________________________________________________________ ________________ Reason given by DOL for denial: Insufficient exposure Lack disease (or documentation of) No RECA accepted claim Unclear/other ________________________________________________ Do you agree with DOL decisions? Yes NoWhy?: Patient may/does have the disease Likely sufficient exposure Info missing Other __________________________________________________________________________ _________ Is more information likely to change your conclusion? Yes No If Yes, What info?_____________________________________ Likely available? Yes No Comments /your conclusions re Claim(s): __________________________________________________ __________________________________________________________________ _________________ ___________________________________________________________________ ________________ Other Comments on Claims / Review process / Records: If multiple decisions / requests for more information, could the correct decision been made earlier? YES NO, Explain:________________________________________________________________ Appropriate referrals made (CMC, SEM, IH)? (Not needed? Additional?) _________________________ YES NO, Explain:________________________________________________________________ Records provided to us adequate? Yes No, Additional records needed: _______________________ Case worthwhile for others to review? Yes No, Issue to focus on:_________________________ Any Other Comments:_________________________________________________________________ ___________________________________________________________________________________ Abbreviations: BeLPT - blood beryllium lymphocyte proliferation test NJMC - National Jewish Medical Center, Denver CO) RECA - Radiation Employees Compensation Act ORAU Oak Ridge Associated Universities, TN

17. Part B Subcommittee: Conclusions to date 1) Sarcoidosis = CBD Should be presumed to be CBD in any worker with possible Beryllium exposure. BeLPT is NOT needed for diagnosis (whether pre or post 1993). 2) Other specific DOL questions mostly answered 3) Initial review of cases Frequently agree with conclusions Issues non-CBD cases (ILD, COPD, SEM) Chest x-ray ILO vs CT scan limitations RECA eligibility year

18. Part B Lung Diseases 1. Beryllium Sensitivity Issues 1.Consistency of testing results amongst different diagnostic facilities Only NJMC and Oak Ridge doing now. Consistent. More labs not helpful 2.Reinterpretation by normal test outcomes as abnormal by a consulting physician ?? BeLPT report should not be reinterpreted. Some confusion with only 1 positive BeLPT test. (A positive test is more than 1 positive SI). 3.New and more relevant science on diagnostic tools for evaluating beryllium sensitivity There isn t (for these purposes) 4.Definition of beryllium medical monitoring i.e. expected medical regimen for monitoring sensitivity to determine if it has progressed to CBD see ATS Doc - should include questionnaire, PFTs, Chest CT if worse spirometry. Chronic Beryllium Disease a.Pre-1993 CBD Any three of the following criteria: -Characteristic chest radiographic (or computed tomography (CT)) abnormalities. -More clear guidance on chest radiographic abnormalities consistent with CBD would be useful. ground glass, bronchial wall thickening, subpleural cysts, thickened interlobular septa. -Restrictive or obstructive lung physiology testing or diffusing lung capacity defect. oPulmonary function test (PFT) is used as diagnostic tool for specific illnesses (i.e. asthma, COPD). Are PFT results within certain ranges consistent with CBD? variable, obstruction, restriction, mixed, low DLCO otherwise normal. -Lung pathology consistent with CBD. oIn most instances, a physician s statement with medical rationale confirming that pathologic test results are consistent with CBD is sufficient to support claim. Additional guidance on lung pathology findings consistent with CBD would be useful. See below b.Post-1993 CBD Criteria. Issues 1.Clarification of the diagnostic and interpretive meaning of characteristic of CBD to differentiate between CBD and other lung disease See ATS doc - The morphology of the granuloma may vary from a loosely formed collection of a few epithelioid histiocytes with scattered lymphocytes to a well-formed one. Fibrosis may develop, and foreign-body granulomas are sometimes seen. An interstitial mononuclear cell infiltrate may be found. (lcytes, plasma cells) 2.Consistent and uniform standard for judging medical evidence for the pre or post 1993 as evidence of a chronic respiratory disorder Onset chronic respiratory symptoms .Cough SOB - records may no longer be available. Necessitating lung lavages or lung biopsy on critically ill or elderly patients NO 3.Obtaining clarity on the specific diagnostic markers required for CBD in the pre or post 1993 diagnostic requirements No other tests available 4.Clearer guidance on the relationship between sarcoidosis and CBD If h/o Be exposure, workplace with Be and diagnosis sarcoid, then diagnosis should be CBD, even if negative BeLPT. 5.Recommendations or advice relating to conditions that are normal and usual consequential illnesses to CBD Complications most chronic lung diseases similar- chronic steroids, hypoxia, right heart failure. CBD systemic - any sarcoid complications. 6.Input or suggestion regarding assessment of negative BeLPT as either false-negative or borderline due to drug interference or other treatment modalities false negatives can occur with blood BeLPT. So if sarcoid, granulo-matous lung disease, diagnosis CBD, even if no BeLPT done or negative. Chronic silicosis Issues 1.Clear guidance on the certification requirements for B-readers and how that is documented on B- reader test results Forms not signed by docs. There is database can search for B reader. Since films now mostly electronic could hire few B readers to read all of them for consistency.? ? 2. 3.