Source: https://www.federalregister.gov/documents/2013/09/19/2013-22800/world-trade-center-health-program-addition-of-prostate-cancer-to-the-list-of-wtc-related-health
Timestamp: 2016-09-26 10:53:13
Document Index: 318723883

Matched Legal Cases: ['art 88', 'art1', 'art 88', '§\u200988', 'art2', '§\u200988', '§\u200988', 'art 88']

:: World Trade Center Health Program; Addition of Prostate Cancer to the List of WTC-Related Health Conditions
A Rule by the Health and Human Services Department on 09/19/2013
57505-57523
https://www.federalregister.gov/d/2013-22800
09/18/2013 at 08:45 am.
Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111-347), amended the Public Health Service Act (PHS Act) to add Title XXXIII [1] establishing the WTC Health Program within the Department of Health and Human Services (HHS). The WTC Health Program provides medical monitoring and treatment benefits to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery, and Start Printed Page 57506cleanup workers (responders) who responded to the September 11, 2001, terrorist attacks in New York City, at the Pentagon, and in Shanksville, Pennsylvania, and to eligible persons (survivors) who were present in the dust or dust cloud on September 11, 2001 or who worked, resided, or attended school, childcare, or adult daycare in the New York City disaster area.
In the preamble to a final rule published on September 12, 2012, the Administrator established a four-part hierarchical methodology to apply in evaluating whether to propose adding certain types of cancer to the List of WTC-Related Health Conditions included in 42 CFR 88.1.[2] Method 1 is the preferred method for adding types of cancer to the List. When the analysis of epidemiologic studies in Method 1 does not support a causal association between 9/11 exposures and a type of cancer, the Administrator applies the criteria of Method 2.[3] If no causal association between a currently listed condition and the type of cancer is identified using Method 2, the Administrator applies the criteria of Method 3. If Method 3 does not indicate that a recognized 9/11 exposure is categorized by the National Toxicology Program (NTP) as a known or reasonably anticipated human carcinogen [4] or the International Agency for Research on Cancer (IARC) has not determined there is sufficient or limited evidence in humans that a 9/11 exposure is causally associated with a type of cancer,[5] then the criteria of Method 4 are applied. Under Method 4, the Administrator determines whether the WTC Health Program Scientific/Technical Advisory Committee (STAC), if consulted, has provided a reasonable basis for adding the type of cancer, aside from Methods 1, 2, or 3 mentioned above. Only where the Administrator is satisfied that one of the four methods provides a reasonable basis to add the cancer will he propose that a type of cancer be added to the List.
On May 2, 2013, the Administrator received Petition 002 from the Patrolmen's Benevolent Association, a union representing New York City police officers. Petition 002 referenced, and relied upon, a study of over 25,000 WTC responders enrolled in the WTC Health Program, authored by Solan et al. and published in the scientific journal Environmental Health Perspectives.[6] Petition 002 asserted that the Solan study:
affirms what was reported in prior published studies, that those exposed to the Ground Zero toxins are at higher risk of developing cancer than the general population. Notably, the Study found a statistically significant incidence rate for prostate cancer, including a 17% greater than expected rate of prostate cancer among responders. According to the Study, these findings were “concordant” with the findings of the New York City Fire Department [FDNY] and the New York City Department of Health and Mental Hygiene World Trade Center Health City Registry.[7] The “prior published studies” referenced in Petition 002 were authored by Zeig-Owens et al., published in The Lancet in September 2011,[8] and by Li et al., published in the Journal of the American Medical Association (JAMA) in December 2012.[9] The Zeig-Owens, Li, and Solan studies were reviewed and analyzed by the Administrator in the notice of proposed rulemaking published July 2, 2013.[10] The Administrator's review focused on the information that the three epidemiologic studies, taken as a whole, provided on the question of the risk of prostate cancer in association with 9/11 exposures and the role of surveillance bias in explaining any observed excess risk. A summary of the Administrator's findings regarding the three studies is offered below, followed by the Administrator's final determination on the addition of prostate cancer to the List.
In response to Petition 002, the Administrator has reviewed the available evidence pertinent to the four-part hierarchical methodology described above.[11] The Administrator's determination to not add prostate cancer in the 2012 rulemaking is superseded by his new evaluation, discussed in the notice of proposed rulemaking. The 2012 evaluation relied on the only epidemiologic study available at that time, Zeig-Owens, and the STAC's assessment of that study and vote to not include prostate cancer in its recommendation. The subsequently published Li and Solan studies present new epidemiologic findings from larger, more heterogeneous populations and present evidence that surveillance bias may not be occurring in the studied populations. Review of the two new studies leads the Administrator to determine that surveillance bias may not fully explain the increased incidence of prostate cancer and, accordingly, the Administrator can no longer attribute increased incidence of prostate cancer to surveillance bias with adequate certainty.
After comprehensive review of all three epidemiology studies of 9/11-exposed populations, the Administrator has determined that the epidemiologic evidence evaluated under Method 1 is inconclusive. Because no relationship Start Printed Page 57507has been identified between prostate cancer and a condition on the List of WTC-Related Health Conditions (Method 2), the review turned to evaluating the evidence of carcinogenicity provided by NTP and IARC under Method 3. The Administrator has determined that, based on the evidence provided in Method 3, prostate cancer will be added to the List of WTC-Related Health Conditions on the effective date for this final rule.
Early detection of cancer in 9/11-exposed populations—either as part of medical monitoring of enrolled WTC responders and survivors or part of ongoing research—is an important adjunct to the WTC Health Program. The WTC Health Program adheres to the recommendations of the U.S. Preventive Services Task Force (USPSTF) with regard to coverage for preventive measures, including screening tests, counseling, immunizations, and preventive medications. The USPSTF recommends against PSA-based screening for prostate cancer.[12] Therefore, PSA-based screening for prostate cancer will not be covered by the WTC Health Program.
While Method 1 is the preferred method, section 3312(a)(6) of the PHS Act does not limit the Administrator's methodology to the use of traditional epidemiologic methods to add conditions to the List (Method 1). Upon thorough review of all available information, including peer-reviewed and unpublished studies, expert opinion, the STAC recommendation solicited by the Administrator for the 2012 rulemaking, and comments from the public, the Administrator determined in the September 2012 final rule that it is reasonable to acknowledge the limitations of traditional epidemiologic methods. As the Administrator concluded, “[r]equiring evidence of positive associations from epidemiologic studies of 9/11-exposed populations exclusively does not serve the best interests of WTC Health Program members.” [13] Accordingly, the three additional hierarchical methods were established to incorporate additional scientific sources of information in the evaluation process.
Analysis under Method 3 also includes identifying those agents categorized (1) by NTP as known or reasonably anticipated to be human carcinogens, and (2) by IARC as known, probable, or possible human carcinogens and having sufficient or limited evidence for causing specific types of cancer in humans. NTP and IARC findings have undergone substantial peer review and/or scientific scrutiny in their development. These authoritative bodies have categorized arsenic and inorganic arsenic Start Printed Page 57508compounds as well as cadmium and cadmium compounds as known human carcinogens, and IARC has determined there is limited evidence that arsenic and inorganic arsenic compounds as well as cadmium and cadmium compounds cause cancer of the prostate.[14] Thus, the criteria in Method 3, established to add a type of cancer based on relevant exposure and an established relationship to a specific type of cancer, have been met and prostate cancer is added to the List of WTC-Related Health Conditions.
The Administrator understands the concerns about the lack of certainty in these methods and potential adverse impact on the VCF. However, the Administrator notes that individuals who are not currently enrolled in the WTC Health Program must first be determined to be eligible and qualified to enroll. The Administrator also notes that listing a cancer as a WTC-related health condition does not necessarily mean that a cancer in an individual WTC responder or survivor diagnosed by a Program physician will be determined to be WTC-related. Each WTC responder and survivor enrolled in the Program will go through a physician's determination and Program certification process to assess whether the individual's cancer meets the statutory definition of a WTC-related health condition.[15] The use of individual medical history and exposure assessment as part of the determination and certification process will reduce the uncertainties inherent in the methods used to determine which cancers to add to the List. Guidelines for determination and certification of a WTC-related health condition have been jointly developed by the WTC Health Program and the Clinical Centers of Excellence (CCE) for conditions on the List. With this input from the CCEs, the WTC Health Program will develop additional instructions to assess, for purposes of certification, whether an individual's 9/11 exposure may have contributed to, aggravated, or caused their prostate cancer. Similarly, the VCF employs rigorous standards used to determine individual compensation awards. The Administrator is not in a position to comment on the budget impact that this regulation will have on the VCF as matters concerning VCF administration are outside the scope of this rulemaking.
For the reasons discussed above and in the notice of proposed rulemaking published July 2, 2013, the Administrator amends 42 CFR 88.1, paragraph (4), Table 1, to add malignant neoplasm of the prostate (prostate cancer) and to add the corresponding medical diagnostic codes.[16] VIII. Regulatory Assessment Requirements
This final rule has been determined not to be a “significant regulatory action” under sec. 3(f) of E.O. 12866, and therefore has not been reviewed by the Office of Management and Budget (OMB). The addition of prostate cancer by this rulemaking is estimated to cost the WTC Health Program between $3,462,675 [17] and $6,995,817 [18] per annum. All of the costs to the WTC Health Program will be transfers after the implementation of provisions of the Patient Protection and Affordable Care Act (Pub. L. 111-148) on January 1, 2014. The rule would not interfere with State, local, and Tribal governments in the exercise of their governmental functions.
The WTC Health Program has, to date, enrolled approximately 58,500 WTC responders and approximately 6,500 survivors, or approximately 65,000 individuals in total. Of that total population, approximately 60,000 individuals were participants in previous WTC medical programs and were `grandfathered' into the WTC Health Program established by Title XXXIII.[19] In addition to those grandfathered WTC responders and survivors already enrolled, the PHS Act sets a numerical limitation on the number of eligible members who can enroll in the WTC Health Program beginning July 1, 2011 at 25,000 new WTC responders and 25,000 new WTC survivors (i.e., the statute restricts new enrollment).[20] Since July 1, 2011, a total of approximately 3,000 new WTC responders and new WTC survivors (over 1,700 responders and 1,200 survivors) have enrolled in the WTC Health Program, resulting in only a minor impact on the statutory enrollment limits for new members. For the purpose of calculating a baseline estimate of cancer prevalence only, the Administrator assumed that this gradual rate of enrollment would continue, and that the currently enrolled population numbers would remain around 58,500 WTC responders and 6,500 WTC survivors. The estimate is further based on the average U.S. cancer prevalence rate and 7 percent discount rate.
As it is not possible to identify an upper bound estimate, HHS has modeled another possible point on the continuum. For the purpose of calculating the impact of an increased rate of cancer on the WTC Health Program, this analysis assumes that the entire statutory cap for new WTC responders (25,000) and WTC survivors (25,000) will be filled. Accordingly, this estimate is based on a population of 80,000 responders (55,000 grandfathered + 25,000 new) and 30,000 survivors (5,000 grandfathered + 25,000 new). The upper cost estimate also assumes an overall increase in population cancer rates (for malignant neoplasm of the prostate [prostate cancer] of 21 percent due to 9/11 Start Printed Page 57509exposure),[21] and costs were discounted at 3 percent. The choice of a 21 percent increase in the risk of cancer of the rate found in the un-exposed population is based on findings presented in the first published epidemiologic study of September 11, 2001 exposed populations.[22] Given the challenges associated with interpreting the Zeig-Owens findings,[23] we simply characterize 21 percent as a possible outcome rather than asserting the probability that 21 percent is a “likely” outcome.
The Administrator estimated the treatment costs associated with covering prostate cancer in this rulemaking using the methods described below. The WTC Health Program obtained data for the cost of providing medical treatment for prostate cancer.[24] The costs of treatment are described in Table A. The costs of treatment are divided into three phases: The costs for the first year following diagnosis, the costs of intervening years or continuing treatment after the first year, and the costs of treatment for the last year of life. The first year costs of cancer treatment are higher due to the initial need for aggressive medical (e.g., radiation, chemotherapy) and surgical care. The costs during last year of life are often dominated by increased hospitalization costs.[25] Therefore, we used three different treatment phase costs to estimate the costs of treatment to be able to best estimate costs in conjunction with expected incidence and long-term survival rates for prostate cancer.
Table A—Average Costs of Treatment for Prostate Cancer (2011$)Initial (12 month)Continuing (annual)Last year of life (12 mos.)$13,696$2,754$43,481
These cost figures were based on a study of elderly cancer patients from the Surveillance, Epidemiology, and End Results (SEER) program maintained by the National Cancer Institute using Medicare files.[26] The average costs of treatment described above are given in 2011 prices adjusted using the Medical Consumer Price Index for all urban consumers.[27] Incident Cases of Cancer
Table B—Percentiles of Current Age (on April 11, 2012) for Current Members in the WTC Health Program by Gender and Responder/Survivor StatusGroupAge percentile (years)Min1103050709099MaxMale responders283239444954627492Female responders283038444954627692Male survivors122335465258678199Female survivors122138495460688495
The Administrator assumed race and ethnic origin distributions for responders and survivors according to distributions in the WTC Health Registry cohort: [28] 57 percent non-Start Printed Page 57510Hispanic white, 15 percent non-Hispanic black, 21 percent Hispanic, and 8 percent other race/ethnicity for responders and 50 percent non-Hispanic white, 17 percent non-Hispanic black, 15 percent Hispanic, and 18 percent other race/ethnicity for survivors. Follow-up for cancer morbidity for each person began on January 1, 2002 or age 15 years, whichever was later. Age 15 was considered because the cancer incidence rate file did not include rates for persons less than 15 years of age. Follow-up ended on December 31, 2016 or the estimated last year of life, whichever was earlier. The estimated last year of life was used since not all persons would be expected to remain alive at the end of 2016. The estimated last year of life was based on U.S. gender, race, age, and year-specific death rates from CDC Wonder (since rates are currently available through 2008, the rate from 2008 was applied to 2009 and later).[29] A life-table analysis program, LTAS.NET, was used to estimate the expected number of incident cancers for prostate cancer.[30] The Administrator calculated cancer incidence rates using data through 2006 from the Surveillance Epidemiology and End Results (SEER) Program and estimated rates for 2007-2016.[31] The Program applied the resulting gender, race, age, and year-specific cancer incidence rates to the estimated person-years at risk to estimate the expected number of cancer cases for prostate cancer starting from year 2002, the first full year following the September 11, 2001, terrorist attacks, to 2016, the last year for which this Program is currently funded.
To determine the potential number of persons in the responder and survivor populations with cancer, the Administrator used the number of incident cases described above for each year starting with 2002 and estimated the prevalence of cancer using survival rate statistics for each incident cancer group through 2016.[32] Using the incident cases and survival rate statistics, HHS has estimated the prevalence (number of persons living with cancer) of cases during the 15 year period (2002-2016) since September 11, 2001. The resulting table provides for each year from 2002 through 2016, the number of new cases occurring in that year (incidence), the number of individuals who died from their cancer in that year, and the number of persons surviving up to 15 years beyond their first diagnosis (prevalence).[33] For example, in 2002 there are 34.22 projected new cases of prostate cancer, which would be listed as incident cases for that year. The survival rate for prostate cancer in the first year of diagnosis is 99.44 percent.[34] Therefore the number of deceased persons in 2002 would be 34.22 × (1−0.9944) = 0.19. For the prostate cancer prevalence table, in year 2003, the number of incident cases would be 38.55 cases. In addition to 38.55 newly diagnosed cases in 2003, there would be the one-year survivors from 2002 which would be 34.22−0.19 = 34.03 cases. This computation process can be repeated for each year through year 2016. A portion of the prostate cancer prevalence tables are provided in Table C. Prevalence is summarized in Tables E and G. This analysis considers cancers diagnosed in 2002 through 2016.
Table C— Prevalence Table for Prostate Cancer[Based on 80,000 responders]YearYears since 9/11 exposureYears covered by WTC Health ProgramNew/Surv.200220032013201420152016134.2238.55112.54123.98134.46146.33234.03100.76111.92123.29133.72388.6799.55110.57121.81479.0287.5898.33109.22571.1578.6187.1397.82663.2770.4177.8086.23755.7162.7469.8377.15848.2255.0662.0169.01942.1047.9154.7161.611039.7741.5147.2453.951135.0239.3841.1146.771230.9134.8339.1740.881330.4334.2938.561430.2634.101530.06Live cases from previous years0.0034.03654.61759.95875.741000.89Prevalence34.2272.58767.15883.931010.201147.22Last year of life0.190.627.208.199.3110.65
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Table D—Cost per 80,000 Responders for Prostate Cancer, 2011$ Years covered by the WTC Health ProgramYear2014201520161$1,688,586$1,831,435$1,993,0262308,251339,563368,2893274,159304,530335,4644241,216270,809300,8095216,509239,972269,4136193,930214,266237,4867172,786192,305212,4708151,653170,779190,0719131,942150,680169,68510114,331130,098148,57411108,466113,209128,8221295,925107,868112,5861383,81694,438106,1961483,34593,9061582,779Prevalent care3,781,5704,243,2984,666,796Last year of life care356,227404,804463,183Total4,137,7984,648,1025,129,979
The sum of the annual costs in the table for the years 2014 through 2016 represents the estimated treatment costs to the WTC Health Program for coverage of prostate cancer for 80,000 responders. The same process described above was applied to the survivor cohort. Based on the incidence rate expected from the survivor cohort, prevalence tables were constructed. The estimated treatment costs for responders and survivors were re-computed under the following two assumptions: (1) The rate of cancer in the WTC Health Program is equal to the rate of cancer observed in the general population; and (2) the rate of cancer exceeds the general population rate by 21 percent due to their WTC exposures.[35] A summary of the estimated prevalence at the U.S. population average for the assumed population of 58,500 responders and 6,500 survivors is provided in Table E. A summary of the estimated treatment costs to the WTC Health Program is provided in Table F. A summary of the estimated prevalence using cancer rates 21 percent over the U.S. population average for the increased rate of 80,000 responders and 30,000 survivors is given in Table G. A summary of the estimated treatment costs to the WTC Health Program is provided in Table H.
Table E—Estimated Prevalence of Prostate Cancer by Year Based on 58,500 and 6,500 Responder and Survivor Population, Respectively and Assuming Cancer Rates at U.S. Population AveragePopulationPrevalence (incident + live cases)201420152016Based on 58,500 responders646.37738.71838.90Based on 6,500 survivors65.9573.9382.41
Start Printed Page 57512
Table F—Estimated Treatment Costs of Prostate Cancer by Year Based on 58,500 and 6,500 Responder and Survivor Population, Respectively and Assuming Cancer Rates at U.S. Population Average (2011$)Population2014201520162014-2016Based on 58,500 responders$3,025,765$3,398,924$3,751,298$10,175,987Based on 6,500 survivors296,297326,642352,170975,109
Table G—Estimated Prevalence of Prostate Cancer by Year Based on 80,000 and 30,000 Responder and Survivor Population, Respectively and Assuming Incidence of Cancer is 21% Higher Than the U.S. Population Due to 9/11 ExposurePopulationPrevalence (incident + live cases)201420152016Based on 80,000 responders1069.551222.341388.13Based on 30,000 survivors368.31412.86460.19
Table H—Estimated Treatment Costs of Prostate Cancer by Year Based on 80,000 and 30,000 Responder and Survivor Population, Respectively and Assuming Incidence of Cancer is 21% Higher Than the U.S. Population Due to 9/11 Exposure (2011$)Population2014201520162014-2016Based on 80,000 responders$5,089,491$5,717,165$6,309,875$17,116,531Based on 30,000 survivors1,378,9251,520,1381,638,9474,538,010
Table I—Breakdown of Estimated Annual WTC Health Program Transfers for Prostate Cancer Based on 80,000 and 58,500 Responders and 30,000 and 6,500 Survivors, 2014-2016, 2011$ Annualized transfers for 2014-2016, 2011$Discounted at 7 percentDiscounted at 3 percent Cancer Rate U.S. averageU.S. average + 21%58,500 Responders$3,159,6196,500 Survivors$303,05665,000 Total$3,462,67580,000 Responders$5,529,26630,000 Survivors$1,466,551110,000 Total$6,995,817
The Administrator does not have information on the health of the population that may have experienced 9/11 exposures and is not currently enrolled in the WTC Health Program. In addition, the Administrator has only limited information about health insurance and health care services for prostate cancers potentially caused by 9/11 exposures and suffered by any population of responders and survivors, including responders and survivors currently enrolled in the WTC Health Program and responders and survivors not enrolled in the Program. For the purposes of this analysis, the Administrator assumes that broad trends on demographics and access to health insurance reported by the U.S. Census Bureau and health care services for cancer similar to those reported by Ward et al.[36] would apply to the population of general responders (those individuals who are not members of the FDNY and who meet the eligibility criteria in 42 CFR Part 88 for WTC responders) and survivors both within and outside the Program. For the purposes of this analysis, the Administrator assumes that access to health insurance and health care services for FDNY responders within and outside the Program would be equivalent because this population is overwhelmingly covered by employer-based health insurance.
Although the Administrator cannot quantify the benefits associated with the WTC Health Program, members with prostate cancer would have improved access to care and thereby the Program should produce better treatment outcomes than in its absence. Under other insurance plans, patients would have deductibles and copays, which impact access to care and particularly its timeliness.[37] WTC Health Program members would have first-dollar coverage and hence are likely to seek care sooner when indicated, resulting in improved treatment outcomes.
The Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., requires an agency to invite public comment on, and to obtain OMB approval of, any regulation that requires 10 or more people to report information to the agency or to keep certain records. Data collection and recordkeeping requirements for the WTC Health Program are approved by OMB under “World Trade Center Health Program Enrollment, Appeals & Reimbursement” (OMB Control No. 0920-0891, exp. December 31, 2014). The Administrator has determined that no changes are needed to the information collection request already approved by OMB.
In accordance with Executive Order 13211, the Administrator has evaluated the effects of this final rule on energy supply, distribution or use, and has determined that the rule will not have a significant adverse effect.Start Printed Page 57514
Start Amendment Part1. The authority citation for Part 88 continues to read as follows:End Amendment Part
§ 88.1 [Amended]
Start Amendment Part2. In § 88.1, under paragraph (4) of the definition “List of WTC-Related Health Conditions,” revise Table 1 to read as follows:End Amendment Part
§ 88.1 Definitions.
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77 FR 56138, 56142.
The results of epidemiologic studies are the primary and best evidence for making a determination of a causal association between an exposure and a health outcome, such as cancer. An analysis of the results of any epidemiologic study has three possible outcomes: (1) The analysis supports an association between exposures and a health outcome (yes); (2) the analysis supports that there is no association between exposures and a health outcome (no); or (3) the analysis is inconclusive about whether an association exists between exposures and a health outcome (inconclusive).
National Toxicology Program (NTP), U.S. Department of Health and Human Services. Report on Carcinogens (RoC). http://ntp.niehs.nih.gov/​?objectid=​72016262-BDB7-CEBA-FA60E922B18C2540. Accessed August 12, 2013.
World Health Organization International Agency for Research on Cancer (IARC). http://monographs.iarc.fr/​. Accessed August 12, 2013.
Solan S, Wallenstein S, Shapiro M, Teitelbaum SL, Stevenson L, Kochman A, Kaplan J, Dellenbaugh C, Kahn A, Biro FN, Crane M, Crowley L, Gabrilove J, Gonsalves L, Harrison D, Herbert R, Luft B, Markowitz SB, Moline J, Niu X, Sacks H, Shukla G, Udasin I, Lucchini RG, Boffetta P, Landrigan PJ [2013]. Cancer incidence in World Trade Center Rescue and Recovery Workers, 2001-2008. Environmental Health Perspectives 121(6):699-704.
The Petitioner incorrectly states that the Solan study reported a 17 percent increase in prostate cancer. Solan et al. report a 21 percent increase in prostate cancer when the timeframe for diagnosis is unrestricted, and 23 percent when the timeframe for diagnosis is restricted.
Zeig-Owens R, Webber MP, Hall CB, Schwartz T, Jaber N, Weakley J, Rohan TE, Cohen HW, Derman O, Aldrich TK, Kelly K, Prezant DJ [2011]. Early Assessment of Cancer Outcomes in New York City Firefighters after the 9/11 Attacks: An Observational Cohort Study. The Lancet 378(9794):898-905.
Li J, Cone JE, Kahn AR, Brackbill RM, Farfel MR, Greene CM, Hadler JL, Stayner LT, Stellman SD [2012]. Association between World Trade Center Exposure and Excess Cancer Risk. JAMA 308(23):2479-2488.
78 FR 39670, 39674-39675.
See pages 39674-39675 of the notice of proposed rulemaking (78 FR 39670, July 2, 2013).
U.S. Preventive Services Task Force. Recommendation: Screening for Prostate Cancer (2012). http://www.uspreventiveservicestaskforce.org/​prostatecancerscreening.htm. Accessed August 12, 2013.
77 FR 56138, 56156 (September 12, 2012).
Cogliano VJ, Baan R, Straif K, Grosse Y, Lauby-Secretan B, El Ghissassi F, Bouvard B, Benbrahim-Tallaa L, Guha N, Freeman C, Galichet L, Wild CP [2011]. Preventable Exposures Associated with Human Cancers. Journal of the National Cancer Institute 103:1827-1839.
IARC (International Agency for Research on Cancer) [2012]. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans: Vol. 100—A Review of Human Carcinogens. Part C: Arsenic, Metals, Fibres, and Dusts. IARC, Lyon, France. http://monographs.iarc.fr/​ENG/​Monographs/​vol100C/​index.php. Accessed August 7, 2013.
“An illness or health condition for which exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the September 11, 2001, terrorist attacks, based on an examination by a medical professional with experience in treating or diagnosing the health conditions included in the applicable list of WTC-related health conditions, is substantially likely to be a significant factor in aggravating, contributing to, or causing the condition.” PHS Act, sec. 3312(a)(1)(A)(i).
ICD-9 code 185 and ICD-10 code C61. See, respectively, WHO (World Health Organization) [1978]. International Classification of Diseases, Ninth Edition; WHO [1997]. International Classification of Diseases, Tenth Edition.
Based on a population of 60,000 at the U.S. cancer rate and discounted at 7 percent.
Based on a population of 110,000 at 21 percent above the U.S. cancer rate and discounted at 3 percent.
These grandfathered members were enrolled without having to complete a new member application when the WTC Health Program started on July 1, 2011 and are referred to in the WTC Health Program regulations in 42 CFR Part 88 as “currently identified responders” and “currently identified survivors.”
PHS Act, secs. 3311(a)(4)(A) and 3321(a)(3)(A).
As Zeig-Owens et al. point out, the time interval since 9/11 is short for cancer outcomes, the recorded excess of cancers is not limited to specific sites, and the biological plausibility of chronic inflammation as a possible mediator between WTC-exposure and cancer means that the outcomes remain speculative.
Yabroff KR, Lamont EB, Mariotto A, Warren JL, Topor M, Meekins A, Brown ML [2008]. Cost of Care for Elderly Cancer Patients in the United States. Journal of the National Cancer Institute 100(9):630-41.
Surveillance, Epidemiology, and End Results (SEER) Program (www.seer.cancer.gov) Research Data (1973-2006), National Cancer Institute, DCCPS, Surveillance Research Program, Surveillance Systems Branch, released April 2009, based on the November 2008 submission.
Bureau of Labor Statistics. Consumer Price Index. Available at https://research.stlouisfed.org/​fred2/​series/​CPIMEDSL/​downloaddata?​cid=​32419. Accessed August 12, 2013.
Jordan HT, Brackbill RM, Cone JE, Debchoudhury I, Farfel MR, Greene CM, Hadler JL, Kennedy J, Li J, Liff J, Stayner L, Stellman SD [2011]. Mortality Among Survivors of the Sept 11, 2001, Word Trade Center Disaster: Results from the World Trade Center Health Registry Cohort. The Lancet 378:879-887. Note: percentages may not sum to 100 percent due to rounding.
Centers for Disease Control and Prevention, National Center for Health Statistics. Compressed Mortality File 1999-2008. CDC WONDER Online Database, compiled from Compressed Mortality File 1999-2008 Series 20 No. 2N, 2011. http://wonder.cdc.gov/​cmf-icd10.html. Accessed August 12, 2013.
Schubauer-Berigan MK, Hein MJ, Raudabaugh WM, Ruder AM, Silver SR, Spaeth S, Steenland K, Petersen MR, and Waters KM [2011]. Update of the NIOSH Life Table Analysis System: A Person-Years Analysis program for the Windows Computing Environment. American Journal of Industrial Medicine 54:915-924.
National Cancer Institute, Surveillance Epidemiology and End Results (SEER). http://seer.cancer.gov/​. Accessed August 12, 2013.
The 15-year survival limit is imposed based on the analytic time horizon established between the triggering events of September 11, 2001 and the authorization of the WTC Health Program through 2016.
Zeig-Owens R, Webber MP, Hall CB, Schwartz T, Jaber N, Weakley J, Rohan TE, Cohen HW, Derman O, Aldrich TK, Kelly K, Prezant DJ [2011]. Early Assessment of Cancer Outcomes in New York City Firefighters after the 9/11 Attacks: An Observational Cohort Study. The Lancet 378(9794):898-905. Limitations of the Zeig-Owens study include: Limited information on specific exposures experienced by firefighters; short time for follow-up of cancer outcomes; speculation about the biological plausibility of chronic inflammation as a possible mediator between WTC-exposure and cancer outcomes; and potential unmeasured confounders.
Ward E, Halpern M, Schrag N, Cokkinides V, DeSantis C, Bandi P, Siegel R, Stewart A, Jemal A [2008]. Association of Insurance with Cancer Care Utilization and Outcomes. CA Cancer Journal for Clinicians 58:9-31.
Wharam JF, Galbraith AA, Kleinman KP, Soumerai SB, Ross-Degnan D, Landon BE [2008]. Cancer Screening before and after Switching to a High-Deductible Health Plan. Annals of Internal Medicine 148(9):647-655.