World Trade Center Health Program:
Approach Used to Add Cancers to List of Covered Conditions Was Reasonable, but Could Be Improved
GAO-14-606: Published: Jul 23, 2014. Publicly Released: Aug 22, 2014.
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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.
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 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.
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Recommendations for Executive Action
Status: Closed - Implemented
Comments: In response to GAO's recommendation, in July 2015, the World Trade Center Health Program (WTCHP) Administrator clarified that the approach for adding a type of cancer evolved from a hierarchy (ordered from Method 1 through Method 4) to an approach in which each of the methods is independent and equivalent (unordered). He said this approach is preferred because each of the methods has strengths and limitations and contributes differently to the assessment. GAO noted that this change to a non-hierarchical approach did not align with the 2014 policies and procedures document, which still referred to the approach as a hierarchy of methods. Subsequently, in May 2016, the WTCHP revised its policies and procedures document to reflect the change in approach by noting that a type of cancer can be added to the list if the criteria of any of the four methods are met and removing all references to a hierarchy of methods.
Recommendation: To help ensure that future decisions related to adding conditions to the WTCHP list of covered conditions are equitable and credible, the Secretary of HHS should direct the WTCHP Administrator to 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.
Agency Affected: Department of Health and Human Services
Status: Closed - Implemented
Comments: In 2015, HHS indicated that the World Trade Center Health Program (WTCHP) was working on a notice of proposed rulemaking (NPRM) for the addition of acute traumatic injury and new onset COPD to the WTCHP list of covered conditions, and that the WTCHP was planning to conduct a peer review of its determination to propose the addition of these two conditions while the NPRM is open for public comment. Therefore, the WTCHP would consider both the public comments and the results of the peer review when determining whether or not to publish a final rule to add the conditions. According to HHS, the peer review would be including an evaluation of the evidence and would be conducted by independent subject matter experts. HHS also noted that this peer review process would be included in subsequent decisions about adding conditions to the list of covered conditions. In February 2016, HHS reported that the program had completed the planned peer review process to support the program's decision about adding acute traumatic injury and new onset COPD to the WTCHP list. HHS issued a final rule on this decision in July 2016, describing the input received from peer reviewers and the WTCHP Administrator's responses.
Recommendation: To help ensure that future decisions related to adding conditions to the WTCHP list of covered conditions are equitable and credible, the Secretary of HHS should direct the WTCHP Administrator to include an independent peer review in the approach for adding to the list of covered conditions, seeking authority to extend time frames if necessary.
Agency Affected: Department of Health and Human Services