The Zadroga Act established the WTCHP to provide medical monitoring and treatment benefits, and reactivated the VCF to provide financial compensation to eligible individuals. As of March 31, 2014, there were 67,783 WTCHP enrollees, including responders and survivors from the WTC attack site and responders from the Pentagon and Shanksville, Pennsylvania, attack sites. Monitoring, for the purposes of this report, includes initial health and diagnostic evaluations, screening tests, and monitoring exams. Treatment provided by the WTCHP must be deemed medically necessary, and in accordance with the WTCHP’s medical treatment protocols. WTCHP services are provided to enrollees at no cost, through contracts with Clinical Centers of Excellence (CCE) in the New York metropolitan area and the Nationwide Provider Network (NPN) for those who reside outside of the New York metropolitan area. Under the Zadroga Act, the Administrator may publish a rule to add conditions to the list of covered conditions at his discretion. If the Administrator receives a written petition requesting the addition of a condition to the list, the law specifies certain time frames in which he must respond to that petition. Specifically, upon receipt of a petition to add a health condition to the list, the Administrator is required to respond within 60 days in one of four specified ways: (1) request a recommendation of the STAC; (2) publish a proposed rule in the Federal Register to add the condition; (3) publish in the Federal Register a determination not to publish such a rule; or (4) publish in the Federal Register a determination that insufficient evidence exists to take any such action. If the Administrator chooses to request a recommendation of the STAC, the STAC has up to 180 days to provide it, and the Administrator has up to 60 days, following the receipt of the STAC’s recommendation, to publish a decision on whether to add the condition in the Federal Register. Therefore, when a recommendation from the STAC is requested for a review based on a petition, up to 300 days may elapse from the time the Administrator receives the petition to when he publishes a response in the Federal Register. In response to the September 2011 written petition from members of Congress to add coverage for cancer, the Administrator requested a recommendation from the STAC, which, in March 2012, provided its recommendation to add certain types of cancers to the list. The Administrator then conducted his own assessment of available scientific evidence, including an assessment of the STAC’s recommendation. To obtain coverage for treatment for a condition included on the list, a WTCHP enrollee must obtain a determination from a CCE or NPN physician, and a certification from the WTCHP. Specifically, a physician must determine that (1) the condition for which the enrollee seeks coverage is on the list; and (2) exposure to airborne toxins, other hazards, or adverse conditions resulting from the September 11 attacks is “substantially likely to be a significant factor in aggravating, contributing to, or causing the condition.” The WTCHP then reviews the physician’s determination and certifies that the enrollee satisfactorily meets the exposure assessment and symptom requirements. Once an enrollee’s condition has been certified for coverage, a WTCHP provider can be reimbursed for treatment services provided for that specific health condition. The Zadroga Act established the WTCHP Fund and made appropriations to that fund for the federal share of expenditures for the last calendar quarter of fiscal year 2011, as well as for each of fiscal years 2012 through 2016, totaling a maximum of about $1.6 billion. 2014, cumulative WTCHP obligations totaled about $0.8 billion. About one-half of that amount ($450.9 million) was obligated to pay for claims from the CCEs and the NPN. The remaining amount ($326.2 million) was obligated for CCE and NPN infrastructure, education and outreach, the STAC, data centers, and other activities. Claims paid from October 2012 (when cancers were added to the list) through March 2014 totaled about $140.7 million. In addition, the estimated costs of the CCE and NPN contracts for the 5-year period ranged from about $5.9 million to nearly $55.0 million. (See table 1.) The Zadroga Act specified that the federal share of funding for the WTCHP was to be the lesser of either 90 percent of expenditures for a year, or an amount specified for that year. The amount provided for fiscal year 2016 is limited to any unexpended funds remaining available from fiscal years 2011 through 2015. Federal payments are conditioned on New York City agreeing to contribute 10 percent of the program’s costs through fiscal year 2015 and one-ninth of any federal spending in fiscal year 2016. The NPN is operated by Logistics Health, Inc., which subcontracts with health systems, such as UnitedHealthcare, to provide services to enrollees, according to WTCHP officials. Rules reactivating the VCF under the Zadroga Act became effective October 3, 2011.death resulting from traumatic physical injuries, physical health conditions, or diseases considered to have occurred as a result of the September 11 attacks or debris removal. The VCF provides compensation for personal injury or An individual must register with the VCF within 2 years of diagnosis with a covered condition, but not later than October 3, 2016. Individuals with an existing condition have 2 years from the date the condition is added to the WTCHP list to register with the VCF; all registrations must be submitted by October 3, 2016. As such, individuals who were diagnosed with a cancer added to the list on October 12, 2012, are required to register by October 12, 2014. To file a VCF claim, an individual must submit completed eligibility and compensation claim forms, including information that demonstrates a physical health condition included in the WTCHP list resulted from the September 11 attacks, by October 3, 2016. Although there had been over 60,000 individual registrations with the VCF as of March 31, 2014, most claimants had not submitted eligibility or compensation forms as of that date. The Zadroga Act capped funding for VCF compensation at nearly $2.8 billion, which covers both claims and administrative costs. Of that amount, $875 million (31 percent) is available for payments during the VCF’s first 5 years after its reactivation (from Oct. 3, 2011, through Oct. 3, 2016). The act required the VCF to set a rate for prorating payments during the first 5 years to ensure that every eligible claimant received a payment during that period. In January 2013, the VCF set a proration amount of 10 percent of total compensation calculations for those first 5 years. In the VCF’s sixth year (from Oct. 3, 2016, through Oct. 3, 2017), the program will make payments based on the remaining funds. After all payments are made, the VCF shall be permanently closed. In determining whether to add cancers to the list of covered conditions, the Administrator used a hazard-based, multiple method approach. Experts who participated in our meeting indicated that this approach was reasonable. However, the approach could be improved, as it was not clearly communicated and did not include an independent peer review. The WTCHP Administrator used a hazard-based, multiple-method approach—rather than a risk-based approach—to determine whether to add certain types of cancer to the list. The Zadroga Act does not prescribe a specific methodology for assessing evidence to determine whether to add new conditions to the list. According to experts who a hazard-based approach focuses on participated in our meeting,identifying whether particular “hazards”—sources of potential harm—are associated with certain health conditions, and does not attempt to quantify the risks or likelihood of developing those health conditions as would a risk-based approach. Under the Administrator’s hazard-based approach, types of cancer found to be associated with exposures to the September 11 attack sites were added to the list. In contrast, a risk-based approach would have involved determining whether the risk of a specific type of cancer from the September 11 exposures was high or low as a result of quantified levels and durations of exposure, and would have added only those cancers where risk was determined to be high. The Administrator’s hazard-based approach used four methods to determine whether there was an association between a September 11 exposure and a particular cancer that warranted adding that cancer to the list. According to the approach described in rulemaking,Administrator may have added a cancer to the list in the following circumstances: Method 1: Data from published, peer-reviewed epidemiologic studies in the September 11 exposed population supported a causal association between September 11 exposures and the cancer type. Method 2: Multiple published epidemiologic studies supported a causal association between the cancer and a condition already on the list (such as esophageal cancer and gastroesophageal reflux disease). Method 3: A hazard identified at the September 11 attack sites in peer-reviewed studies was identified by the National Toxicology Program to be (or reasonably anticipated to be) a human carcinogen, and the International Agency for Research on Cancer determined that there was at least limited evidence that the hazard causes the cancer. Method 4: The STAC provided a reasonable basis to add a cancer to the list based on its review of scientific and medical evidence. The Administrator characterized his hazard-based, multiple-method approach as a hierarchy in 2012 rulemaking. To determine whether to add a particular type of cancer, the Administrator said he began his review by assessing evidence under Method 1, which he considered to be the strongest type of evidence. If a cancer did not meet the criteria to be added to the list under Method 1, the Administrator considered evidence under Methods 2, 3, or 4, which he considered to be less rigorous forms of evidence. The Administrator told us that when evidence that supported the addition of a cancer was available under a method higher in the hierarchy, he did not consider evidence under the methods lower in the hierarchy. (See fig. 1 for a flowchart of the approach presented in the 2012 rulemaking adding cancers to the list.) To make its recommendation regarding the addition of cancers to the list, the STAC reviewed the same types of sources used by the Administrator—that is, epidemiologic studies, studies on causal associations between a cancer type and a condition on the list, and information from the International Agency for Research on Cancer and the National Toxicology Program. The STAC, however, did not report using specific criteria to assess whether the epidemiologic evidence reviewed supported a causal association between September 11 exposures and a cancer type, but did document its rationale for adding certain types of cancer in a letter to the Administrator. To evaluate whether the epidemiologic studies reviewed under Methods 1 and 2 supported a causal association between the cancer type and either September 11 exposures or another condition on the list, the Administrator used criteria established by epidemiologist Austin Bradford Hill (known as the Bradford Hill criteria), commonly used to assess relationships between exposure and health outcomes. The Administrator described the use of specific Bradford Hill criteria under certain circumstances in his approach (for example, when only one epidemiologic study was available) in World Trade Center Health Program; Addition of Certain Types of Cancer to the List of WTC-Related Health Conditions (Notice of Proposed Rulemaking). See 77 Fed. Reg. 35578, 35580 (June 13, 2012) (preamble, III.D.2. and III.D.3.). NTP refers to the National Toxicology Program, which is an interagency program of the Department of Health and Human Services established to provide information about potentially toxic substances. IARC refers to the International Agency for Research on Cancer, which is the World Health Organization’s agency that promotes international collaboration in cancer research. STAC refers to the WTCHP Scientific/Technical Advisory Committee, an advisory committee established by the Administrator to, among other things, review scientific and medical evidence and make recommendations on the addition of eligibility criteria and covered health conditions. Of the 60 types of cancers that the Administrator added to the list, 53 were added using Method 3, 6 using Method 4, and 1 using Method 2. No cancers were added based on Method 1. (See text box, below, for examples of how two cancers were added to the list and appendix III for a list of cancers added to the list by method.) Examples of the World Trade Center Health Program (WTCHP) Administrator’s Application of the Hazard-Based, Multiple-Method Approach: Example 1: Esophageal Cancer Method 1: The Administrator considered adding the cancer to the WTCHP list of covered conditions under Method 1; however, no evidence was available under this method to support its addition. Method 2: The Administrator then assessed scientific information that supported a causal relationship between esophageal cancer and gastroesophageal reflux disease—the latter, a condition already on the WTCHP list—and determined that the information was sufficient to add the cancer. Methods 3 and 4: According to the Administrator, the consideration of these less rigorous methods was not needed given the evidence available under Method 2. Decision: Add esophageal cancer based on evidence considered under Method 2. Example 2: Thyroid Cancer Method 1: Epidemiologic evidence demonstrated an association between September 11 exposures for New York City firefighters and thyroid cancer. However, the Administrator reported in proposed rulemaking that he would not add the cancer under Method 1 as that association was not significantly higher than for firefighters with the cancer who were not exposed to the September 11 attack site. Methods 2 and 3: No evidence was available under these methods to support adding the cancer. Method 4: The Administrator found that the WTCHP Scientific/Technical Advisory Committee (STAC) provided a “reasonable basis” for including thyroid cancer; the STAC reviewed the same evidence the Administrator reviewed under Method 1. Decision: Add thyroid cancer based on evidence considered under Method 4. In deciding on the approach to use, the Administrator reported trying to strike a balance between the program’s need to provide timely health care services to affected September 11 responders and survivors, and the limited availability of scientific information. He reported considering an alternative approach that would have presumed September 11 exposures could have resulted in the development of any and all types of cancer. However, he decided against such an approach because it would not require any scientific evidence as a basis for determinations. Alternatively, the Administrator considered an approach that would have relied only on epidemiologic studies that demonstrated an association between September 11 exposure and the development of a type of cancer. He ultimately decided against such an approach because epidemiological studies linking conditions with September 11 exposure may not yet have been published, due to the long latency period for certain cancers. Waiting for such studies could prevent coverage for some responders and survivors with conditions that may have been related to September 11 exposures, according to the Administrator. Experts at our meeting indicated that the Administrator’s decision to use a hazard-based, multiple-method approach resulted in a high degree of inclusivity, allowing more types of cancers to be added to the list than other approaches might have allowed. According to these experts, this high degree of inclusivity could result in individuals with cancers not related to September 11 exposures seeking coverage from the WTCHP program for these cancers, while a lower degree of inclusivity, which would have resulted from using a risk-based approach, could have meant some individuals with cancers related to September 11 exposures would not have been able to obtain coverage. According to experts participating in our meeting, the Administrator’s approach was reasonable. Both hazard-based and risk-based approaches can be used for determining associations between exposures and health outcomes, according to these experts. They indicated that the Administrator’s use of a hazard-based, multiple-method approach was reasonable given the certification process and data constraints for the WTCHP, and the use of similar approaches by other federal compensation programs. Specifically, they indicated the following: Certification process. Experts highlighted the fact that an applicant must obtain certification to receive coverage for treatment, and as part of this process provide information comparable to that used in a risk- based approach, adding some of the benefit of that type of approach. The Administrator explained that the information reviewed during the certification process includes assessing WTCHP enrollees’ time period of exposure, duration of exposure, temporal sequence of symptoms, and activities that caused the exposure. In addition, qualitative exposure assessments are performed to determine whether enrollees have met the requirements needed for certification that their condition be covered. Data Constraints. Experts told us that developing a risk-based approach would have been less feasible than developing a hazard- based approach. Specifically, a risk-based approach would have required data on levels of exposures to specific hazards among individuals, but such data (for example, epidemiologic studies regarding cancer risk in the exposed population) was lacking. This point was confirmed by the Administrator who told us that using a risk- based approach would have been challenging due to the lack of data on individual exposures following the attacks, especially in the immediate aftermath of the attacks when exposures were at their highest. According to experts, the multiple-method approach was reasonable because of limitations in available data due to the length of cancer latency and the relatively short period of time that had elapsed between the attacks and the Administrator’s review. Use of Similar Approaches. Other federal compensation programs, such as those for Gulf War Veterans, used a similar hazard-based or multiple-method approach to assess the available, often limited, data about relationships between exposures and health outcomes, according to the experts. For example, under the Persian Gulf War Veterans Act, the Secretary of Veterans Affairs was required to use the National Academy of Sciences to determine whether certain health conditions had a relationship with specific war-related exposures; the Academy performed this task through committees convened by its IOM. The IOM committees used a similar hazard- based approach as the Administrator, and did not consider the magnitude of the risk as would have been done with a risk-based approach. IOM officials responsible for directing these committees also told us that the Administrator’s approach was reasonable given the limitations of the available evidence, due in part to cancer latency. Although experts participating in our meeting considered the Administrator’s approach reasonable, they indicated that the approach could have been communicated more clearly to strengthen the credibility of the process. According to these experts, the approach was not clearly described in 2012 proposed and final rulemaking. Specifically, the Administrator did not clearly communicate the approach when there was negative evidence (information that supported not adding a cancer) under one method and positive evidence (information that supported adding a cancer) under a different method. The approach described in the flowchart and text in 2012 rulemaking (see fig. 1) suggested that if there was positive evidence under a given method (for example, Method 3), the Administrator would add the cancer to the list and cease assessing evidence; he would not consider negative evidence found under methods higher in the hierarchy (Methods 1 or 2), or any evidence under methods lower in the hierarchy (Method 4) in making his decision of whether to add that cancer to the list. The Administrator told us, however, that in the case of prostate cancer, negative evidence under Methods 1 and 4 led to his decision not to add prostate cancer during rulemaking in 2012, even though there was positive evidence under Method 3. He agreed that the process for decision making when there was negative evidence under a method higher in the hierarchy and positive evidence under a method lower in the hierarchy was not expressed in the flowchart or text included in 2012 proposed and final rulemaking. He acknowledged that it was an oversight not to have included this information. Further, according to the Administrator, decisions to add a condition to the list could be reconsidered with new evidence; however, the approach outlined in 2012 rulemaking did not clearly communicate how he would assess such new evidence, for example from future studies, against existing evidence. Information about decision making should be adequately communicated to external stakeholders, such as Congress and the public, according to Standards for Internal Control in the Federal Government. Additionally, clear communication is particularly important as the Administrator plans to use the same approach to make future determinations on potential additions of cancer to the list. In the absence of a clearly communicated description, the approach may not be consistently applied during such future decision making, which could raise questions not only about the approach’s credibility, but also equity for program enrollees. In addition to improvements regarding communication, the Administrator’s approach could be improved by the use of an independent peer review process, according to experts who participated in the meeting we convened. This peer review process would include, for example, an evaluation of scientific and technical evidence by independent experts to assess the validity and credibility of the information upon which decisions are being made. Experts participating in our meeting noted that independent peer review has been used to review conclusions made by IOM committees assessing scientific evidence related to exposures and health outcomes for other federal compensation programs. In these instances, peer reviewers independent of the IOM committee provided feedback on matters such as whether the specific evidence assessed by the committee was appropriate, what additional evidence should be assessed, and if aspects of the committee’s report could be more clearly described. committees, independent peer review helps ensure that a committee’s assessment of scientific evidence is accurate and as effective in relaying its conclusions as possible. This assurance enhances the credibility of the final product by ensuring that the conclusions are scientifically based and appropriately portrayed, according to IOM officials. According to IOM officials, independent peer reviewers are selected based on their familiarity with the subject(s) addressed by the committee and conduct their evaluation of the report independent of the committee; however, the reviewers themselves may be stakeholders or those with known opinions on the subject. While the Administrator agreed that independent peer review was important, he told us that, due to time constraints, he did not use it in his approach for the 2012 decisions. Specifically, he told us that although he supported the use of independent peer review in all NIOSH programs, he did not consider implementing such a process feasible given the time limitations in place under the Zadroga Act for responding to petitions and receiving a recommendation from the STAC. According to the act, when a recommendation from the STAC is requested for a review based on a petition, up to 300 days may elapse from the time the Administrator receives the petition to when he publishes a response in the Federal Register. The Administrator told us that the time limits imposed by the Zadroga Act for the review of petitions and responses to STAC recommendations, in addition to the time needed for administrative processes, are very restrictive and provide little time for scientific analysis and decision-making processes. However, without an independent peer review process through which an independent party has determined that the evidence assessed was appropriate and that the rationales for decisions made were clearly described, there may be questions around the transparency of the process and whether the decisions made were appropriate. WTCHP spending on services (claims paid) directly attributable to the addition of cancers to the list of covered conditions accounted for 6.5 percent of total spending on services from October 2012 (the month when cancers were added) through March 2014. The addition of cancers also led to the need for a third-party administrator to facilitate uninterrupted care for enrollees with cancer. WTCHP officials and others reported that the addition of cancers has helped ensure access to high- quality cancer care for enrollees, but also required increased staff to accommodate the program’s growing scope. WTCHP spending on services provided to enrollees that was directly attributable to the addition of cancers to the list totaled $9.1 million, 6.5 percent of the $140.7 million in total spending on services from October 2012 through March 2014. The $9.1 million in spending included: about $1.9 million on cancer monitoring for enrollees, regardless of whether they were diagnosed with any of the conditions on the list; and $7.2 million on cancer treatment for enrollees who had cancer certifications. Enrollees who received these cancer monitoring and treatment services may have joined the program before or after cancer coverage became effective (Oct. 12, 2012). In addition to the spending directly attributable to the addition of cancers, an additional $2.2 million spent on enrollees who joined the program on or after October 12, 2012 (1.5 percent of total spending on services from October 2012 through March 2014) also may have resulted from the addition of cancers. Enrollees who joined the program after October 12, 2012, may have joined as a result of the addition of cancers to the list, even if they only received services for noncancer conditions. The $2.2 million in spending included about $1.6 million on noncancer monitoring for these enrollees. It also included about $0.6 million on noncancer treatment for enrollees who had certifications for noncancer conditions only. (See table 2.) WTCHP officials reported that the addition of cancers to the list led to the need for a third-party administrator to help the program provide uninterrupted cancer-related services to enrollees who had been receiving care outside of the program. Cancer care for any individual (regardless of WTCHP enrollment) requires the provision of services by multiple physicians, such as oncologists, surgeons, infectious disease specialists, and nephrologists, according to a WTCHP Responder Steering Committee member and a CCE official. Initially, to ensure uninterrupted access to services for enrollees already receiving cancer services from physicians outside the CCEs or NPN, the CCEs and NPN credentialed such physicians on a case-by-case basis, which, according to a WTCHP Responder Steering Committee member, was an unwieldy process and risked delaying the certification and treatment of enrollees.Furthermore, the program needed to establish a separate billing arrangement for each physician, and doing so risked delaying the payment of claims. According to WTCHP officials, CDC did not establish a single contract between the agency and a third-party administrator because of time constraints. They said that to meet the immediate need of program enrollees with cancer, each CCE needed to establish a separate subcontract. which fell well below the combined maximum amounts negotiated for each contract. (See table 3.) According to a WTCHP Responder Steering Committee member and a CCE official, HealthSmart recruits providers to join a network, or makes other case-by-case arrangements with providers, so that WTCHP enrollees have the option of continuing to receive cancer services from physicians outside of the CCEs without interruption. In addition to providing access to providers, HealthSmart also provides enrollees with case management services and access to a 24/7 nurse triage line. Additionally, it processes claims for services provided through its network, and performs network credentialing and contracting as needed. WTCHP officials told us they were not aware of any enrollees who were unable to receive needed cancer-related services through the WTCHP. Officials we spoke with reported that the addition of cancers to the list has helped ensure that enrollees have access to high-quality cancer care, which may contribute to better health outcomes. In particular, the WTCHP has provided access to high-quality cancer care because providers affiliated with the CCEs have experience treating cancer patients and are well suited for monitoring recurrences and complications, according to officials associated with the WTCHP. In addition, officials noted that the network established by HealthSmart on behalf of the CCEs includes physicians that specialize in cancer care and provide high-quality services. WTCHP officials and others also reported that the addition of cancers has helped ensure access to high-quality cancer care because the program developed cancer-related policies and procedures using appropriate guidance. The WTCHP implemented a cancer treatment plan, and prescription drug formulary, allowing providers who participate in the WTCHP the ability to provide medically necessary treatment, including medications, according to the National Comprehensive Cancer Network’s Clinical Practice Guidelines in Oncology. In addition, physicians have provided colon and breast cancer screenings for members who meet certain criteria as recommended by the U.S. Preventive Services Task Force.high-quality care, including cancer-related monitoring that could result in According to officials associated with the WTCHP, access to early detection of the disease, may contribute to better health outcomes for enrollees who otherwise would not have had access to such services. Although WTCHP officials and others reported that the addition of cancers has helped ensure access to high-quality care, they reported that these additions also led to the need for dedicating significant amounts of staff time, and for hiring new staff. According to WTCHP officials, a CCE official, and a WTCHP Responder Steering Committee member, after cancers were added to the list, NIOSH and the CCEs needed to dedicate a large amount of staff time to develop and implement policies and procedures that would address the needs of enrollees seeking cancer services. For example, NIOSH had to hire a consultant to help evaluate whether certain procedures were medically necessary for cancer treatment and the CCEs had to increase the amount of staff time dedicated to: providing case management services to enrollees; educating affiliated physicians regarding WTCHP coverage rules; facilitating cancer diagnostic services for enrollees immediately after “red flag” symptoms are identified, particularly for cancer types that need frequent follow-up services (such as colon cancer and thyroid cancer); responding to end of life issues affecting enrollees and their families; and reviewing the most up-to-date guidelines on screening for certain cancer types (such as colon cancer and breast cancer), and working with NIOSH to develop WTCHP screening protocols. A WTCHP Responder Steering Committee member told us the program may encounter future challenges as enrollment increases as a result of the addition of cancers, including increased wait times and an increased rate of spending. The member said that program enrollment is likely to increase significantly, which could result in extended wait times to obtain appointments for enrollees seeking non-urgent services. The member added that there had been no observable effects yet, but that wait times may soon increase as the program anticipates a large influx of enrollees as responders and survivors seek certifications from the WTCHP in order to document their VCF eligibility. The member also expressed concern about the finite funding for the WTCHP, and said that the cost of treating cancer is expected to be higher than the cost of treating other serious conditions such as certain lung diseases. CDC forecast that the annual cost of adding cancers to the list could range from about $12.5 million to $33.3 million; however, this estimate was made before verifiable data on the cancer status of WTCHP enrollees were available.2014, CDC had yet to revise the estimate to include fiscal year 2013 spending and enrollment data. The effects on the VCF of adding cancers to the WTCHP list of covered conditions are not yet known because there have been only a small number of compensation decisions. As of March 31, 2014, there were 502 VCF compensation decisions, totaling $194.6 million, while 5,587 claimants had been found eligible to receive compensation. The number of compensation decisions is limited in part because many of the forms submitted by claimants did not contain sufficient information. Specifically, as of March 31, 2014, only 1,237 claimants (22.1 percent of the 5,587 eligible claimants) had submitted both eligibility and compensation forms that VCF determined to be actionable for compensation decisions. Further adding to the challenge of determining the effects on the VCF of adding cancers to the list, few of the compensation decisions to date have been for claimants with cancer, either alone or in combination with other conditions. Specifically, of the 502 compensation decisions, only 39 were for claimants with cancer; compensation calculations for these individuals totaled $15.6 million (8.0 percent of the $194.6 million calculated for all compensation decisions). The remaining 463 compensation decisions were for claimants who had a noncancer condition only, and totaled $179.0 million (92.0 percent of the total $194.6 million). (See table 4.) VCF officials indicated that the amount set for prorating initial VCF payments accounted for the cancers that have been added to the list. The Zadroga Act required VCF to set a proration amount to ensure that every eligible claimant received a payment during the first 5 years of the program’s reactivation. VCF officials told us that in setting this proration amount at 10 percent, the program took into account all September 11- related physical injuries covered by the VCF, including the 60 cancers added to the list. As of March 31, 2014, VCF had issued initial prorated payments to 310 of the 502 claimants who received compensation decisions from the VCF, totaling $13.0 million. Final payments will be sent to claimants in Year 6 of the program based on remaining funds. Officials stated that no significant administrative changes to the VCF resulted specifically from the addition of cancers to the list. Although the VCF added 44 new staff members in fiscal year 2013, VCF officials reported that these staff members were hired as a result of the overall increase in eligibility and compensation forms, and related documentation submitted by claimants. As of March 31, 2014, the number of claimants who had submitted eligibility and compensation forms for which cancer was the only condition was low (3.2 percent), and had not required the need for additional staff. They said the remaining claims that included cancer were from claimants who also had noncancer conditions that likely would have led to a claim regardless of the addition of cancer coverage. For responders and survivors who suffered serious health problems as a result of September 11 exposures, the WTCHP and VCF may be important sources of needed health-care services or financial assistance, respectively. Among other factors, eligibility for these programs is contingent on an individual having a covered health condition for which exposure to the September 11 attacks was “substantially likely to be a significant factor in aggravating, contributing to, or causing.” Consequently, it is important to ensure that additions to the list of covered conditions are made in a transparent and credible manner. Although experts participating in the meeting we convened indicated that the WTCHP Administrator’s approach to determining whether to add cancers to the list was reasonable, they also indicated that the approach was not communicated clearly and lacked an independent peer review. Standards for internal control also state that administrative decisions should be clearly communicated. The lack of a clearly communicated approach could result in difficulty replicating the approach during future decision making, which may affect the equity and credibility of the overall process. In addition, the WTCHP missed an important opportunity to validate its approach by not using an independent peer review process to, among other things, assess the validity and credibility of the information upon which decisions were being made, as has been used by other federal compensation programs making similar coverage decisions. The time constraints imposed by the Zadroga Act may preclude the inclusion of such a process; however, the addition of an independent peer review process may help ensure the credibility of the Administrator’s approach, which is especially important to the extent that he plans to use the same or a similar approach for future coverage decisions. To help ensure that future decisions related to adding conditions to the WTCHP list of covered conditions are equitable and credible, we recommend that the Secretary of HHS direct the WTCHP Administrator to take the following actions: communicate clearly, through rulemaking or other means, the approach for decision making related to the addition of covered conditions to the list, including a clear delineation of the relationship between methods when conflicting evidence is available. include an independent peer review in the approach for adding to the list of covered conditions, seeking authority to extend time frames if necessary. We provided a draft of this report to HHS and DOJ for their review, and HHS provided written comments (see app. IV). HHS supports our recommendation to clearly communicate the WTCHP’s approach for decision making related to the addition of covered conditions to the list. In its written comments, HHS indicated that, since the publication of rulemaking on the decision to add cancers, the WTCHP published a policy document on its website that further clarified the approach. However, neither the policy document nor the 2012 proposed and final rulemaking fully describe the approach used by the Administrator. Specifically, these documents indicate that if any of the methods provide evidence to support adding a cancer to the list, the cancer will be added. As noted in the report, the Administrator told us that, despite having evidence under Method 3 supporting the addition of prostate cancer to the list, he decided not to add this cancer during 2012 rulemaking because of negative evidence under Methods 1 and 4. Thus, we continue to believe that a complete description of the process is needed to ensure that the approach is consistently applied during future decision making. In regard to our recommendation on the inclusion of an independent peer review process, HHS indicated that it supports the intent of the recommendation, but noted concerns about the implementation of such a process given statutory time restrictions. Specifically, HHS explained that if the WTCHP Administrator receives a petition to add a health condition to the list, the Administrator must take one of four actions within 60 days of receipt of the petition. Our report provides a detailed description of the time frames imposed by the Zadroga Act when responding to a petition requesting the addition of a condition to the list. The report also acknowledges that these statutory time frames may preclude the inclusion of a peer review process in the approach. However, we continue to believe that the inclusion of an independent peer review process is important to ensure that future decisions related to the addition of conditions to the list are equitable and credible, which is why our recommendation accounts for the possibility that HHS may need to seek a legislative change—namely, to extend these time frames—to include a peer review process in the approach. HHS and DOJ both provided technical comments, which we incorporated as appropriate. As agreed with your office, unless you publicly announce the contents of this report earlier, we plan no further distribution until 30 days from the report date. At that time, we will send copies of this report to the Secretary of Health and Human Services and the Attorney General of the Department of Justice, and other interested parties. In addition, the report will be available at no charge on GAO’s Web site at http://www.gao.gov. If you or your staff have any questions about this report, please contact me at (202) 512-7114 or at draperd@gao.gov. Contact points for our Office of Congressional Relations and Office of Public Affairs can be found on the last page of this report. Other major contributors to this report are listed in appendix V. The World Trade Center Health Program (WTCHP) Scientific/Technical Advisory Committee (STAC) is an advisory committee established pursuant to the law to, among other things, review scientific and medical evidence and make recommendations to the program Administrator on eligibility criteria, and the addition of covered health conditions. The law required the Administrator to appoint the members of the STAC and include at least: four occupational physicians, at least two of whom have experience treating World Trade Center (WTC) rescue and recovery workers; one physician with expertise in pulmonary medicine; two environmental medicine or environmental health specialists; one industrial hygienist; one mental health professional; two representatives of WTC responders; and two representatives of certified-eligible WTC survivors. The WTCHP Administrator first solicited nominations to serve on the STAC in June 2011 through an announcement in the Federal Register. According to the Administrator, since this primarily resulted in responses from individuals in the New York City region, WTCHP and other officials from the Centers for Disease Control and Prevention also contacted additional individuals outside of the New York City region to expand the geographic diversity of the STAC membership. The Administrator also told us that he added a third representative of WTC responders to ensure that the different types of responder groups were represented on the committee. The Administrator also added a third representative for the survivors to ensure equal representation between the responder and survivor groups. In determining whether to add cancer, to the WTCHP list of covered conditions, in September 2012, the WTCHP Administrator developed a four-method approach. Following that approach, the Administrator may have added a cancer to the list in the following circumstances: Method 1: epidemiologic studies in the September 11-exposed population supported a causal association between September 11 exposures and the cancer type; Method 2: there were established causal associations between the cancer and a condition already on the list; Method 3: a hazard identified at the September 11 attack sites was identified by the National Toxicology Program to be (or reasonably anticipated to be) a human carcinogen, and the International Agency for Research on Cancer determined that there is at least limited evidence that the hazard causes the cancer; and Method 4: The STAC provided a reasonable basis to add a cancer to the list based on its review of scientific and medical evidence. Of the 60 types of cancers that the WTCHP Administrator added to the list in September 2012, 53 were added using Method 3, 6 using Method 4, and 1 using Method 2. No cancers were added based on Method 1. In addition to the contact named above, Helene Toiv, Assistant Director; Michelle B. Rosenberg, Assistant Director; Jennie Apter; Hernán Bozzolo; Toni Harrison; Emily Ryan; Walter Vance; and George Bogart made key contributions to this report.

Summary: The WTCHP provides health benefits to eligible responders and survivors of the September 11, 2001, attacks. In September 2012, the WTCHP added 60 types of cancer to the list of covered conditions. The VCF—which provides financial compensation to eligible individuals—uses the WTCHP list as a basis for eligibility. GAO was asked to review the WTCHP Administrator's approach to add cancers and the effects of the additions on the WTCHP and VCF. This report (1) describes and assesses the approach for adding cancers to the list of covered conditions, (2) describes the effects the addition has had on the WTCHP, and (3) describes the effects the addition has had on the VCF. GAO reviewed relevant laws and documents, interviewed WTCHP officials, and convened a meeting of experts with the assistance of the Institute of Medicine. GAO examined data for services paid by the WTCHP from October 2012 through March 2014, and VCF claims data as of March 31, 2014. The Administrator of the World Trade Center Health Program (WTCHP)—a program of the Department of Health and Human Services (HHS)—used a hazard-based, multiple-method approach to determine whether to add cancers to the WTCHP list of covered conditions for which treatment may be provided at no cost to an enrollee. Experts who participated in a meeting held by GAO indicated that the Administrator's approach was reasonable but could be improved. According to these experts, a hazard-based approach focuses on identifying whether particular “hazards”—sources of potential harm—are associated with certain health conditions, and does not attempt to quantify the risks of developing those health conditions. The Administrator's approach used four methods to determine whether there was an association between a September 11 exposure and a specific cancer, and thus, whether to add that cancer to the list. The experts considered the approach reasonable given the WTCHP certification process for enrollees to obtain coverage for treatment for a condition on the list, the lack of data related to exposure levels and risks, and the use of similar approaches by previous federal compensation programs. The experts indicated the approach could have been communicated more clearly. For example, the description of the approach in rulemaking did not clearly articulate how decisions would be made when evidence under one method supported adding a cancer type to the list, and evidence under a different method did not. The Administrator noted that this omission was an oversight. Since the Administrator plans to use the same approach in future cancer-related decision making, the absence of a clear description can lead to questions about the credibility and equity of the program. According to the experts, an independent peer review process similar to that used in other federal compensation programs could improve the approach. According to the Administrator, this was not feasible due to time constraints imposed by law. A process through which an independent party assesses the validity of the information upon which decisions are being made and that rationales for decisions are clearly described could help ensure the credibility of the Administrator's approach. WTCHP spending (claims paid) directly attributable to the addition of cancers to the list of covered conditions accounted for 6.5 percent of its total spending on services from October 2012 (when cancers were added) through March 2014. The addition of cancers to the list led to the need for a third-party administrator to help the program provide uninterrupted cancer-related services to enrollees who had been receiving care outside of the program. WTCHP and other officials reported that the addition of cancers has helped ensure enrollees have access to high-quality cancer care, which may contribute to better health outcomes, but required increased WTCHP staff to accommodate the program's growing scope. The effects on the Department of Justice's September 11th Victim Compensation Fund (VCF) of adding cancers to the list of covered conditions are not yet known because there have been a small number of compensation decisions. Of the 502 compensation decisions made as of March 31, 2014, only 39 were for claimants with cancer, either alone or in combination with other conditions. GAO recommends that, to help ensure future decisions are equitable and credible, HHS direct the WTCHP Administrator to communicate clearly the approach used for determining whether to add conditions to its list, and include an independent peer review in the approach, seeking authority to extend time frames if necessary. HHS supports these recommendations, but noted concerns with including a peer review given statutory time frames. GAO acknowledges the time constraints by recommending HHS seek authority to extend the time frames if necessary.