	Background

The Zadroga Act established the WTCHP to provide medical monitoring  and treatment benefits, and reactivated the VCF to provide financial  compensation to eligible individuals. Claims paid from October 2012  (when cancers were added to the list) through March 2014 totaled about  $140.7 million. Experts Indicated That the WTCHP Administrator’s Hazard-Based Approach Was Reasonable, but Could Be Improved

In determining whether to add cancers to the list of covered conditions,  the Administrator used a hazard-based, multiple method approach. 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. 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. Administrator’s Approach Was Not Communicated Clearly and Did Not Include Independent Peer Review

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. Addition of Cancers to the List of Covered Conditions Accounted for a Small Portion of Spending and Led to the Need for a Third- Party Administrator

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. 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. Addition of Cancers to the List Led to the Need for a Third-Party Administrator

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. The Effects on the VCF of Adding Cancers to the List of Covered Conditions Are Not Yet Known

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. 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. 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. Recommendations for Executive Action

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. 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.
Why GAO Did This Study

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.

What GAO Found

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.

What GAO Recommends

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.