GAO Report on Adding Cancers to WTC Covered Conditions

Categories: Cancer, Emergency Response/Public Sector, World Trade Center Health Program

September 3rd, 2014 10:28 am ET - Paul J. Middendorf, PhD, CIH

The World Trade Center (WTC) Health Program was established by the James Zadroga 9/11 Health and Compensation Act of 2010 (Act), and is administered by the National Institute for Occupational Safety and Health (NIOSH). The Program provides medical monitoring and treatment at no cost for enrolled responders at the WTC and related sites in New York City, Pentagon, and Shanksville, PA. It also provides services for enrolled survivors who were in the New York City disaster area. Health conditions, such as types of cancer, can be added to the list of WTC-related covered conditions after a valid petition has been received and the scientific evidence for causation by exposures at the attack sites is analyzed.

In September of 2011, the Administrator of the WTC Health Program, Dr. John Howard, received a petition from nine New York members of Congress asking him to consider adding cancer to the List. The Administrator reviewed the petition and requested the advice of the WTC Scientific/Technical Advisory Committee (STAC), which provided recommendations to add specific types of cancer. After reviewing the STAC’s recommendation, evaluating the available science, and considering public comment on a proposed rule, in 2012 the Administrator published a final rule which added certain types of cancer to the List and explained the approach used to add the types of cancer.

Recently, the U.S. Government Accountability Office (GAO) evaluated the World Trade Center Health Program’s approach to adding cancers to the List [see:http://www.gao.gov/products/GAO-14-606

]. The GAO found that the Administrator 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. Experts who participated in a meeting held by GAO indicated that the Administrator’s approach was reasonable but could be improved. The GAO reports:

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.

The GAO has recommended that, to help ensure future decisions are equitable and credible, the WTCHP Administrator should 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.

The Administrator addressed the issue of clearly communicating the approach used for determining whether to add conditions to its list when he published in May 2014 a policy and procedures for adding types of cancer to the List. The policy and procedures lays out the types of evidence to be considered, and the process for deciding whether to add a type of cancer, including when evidence under one method supports adding a cancer type to the List, and evidence under a different method does not. The Administrator also published a policy and procedures for adding non-cancer conditions to the List.

The Administrator agrees that independent peer review is important and will explore methods to obtain it within the time constraints imposed by the Act. A possible method to obtain the independent peer review recommended by the GAO would be to conduct peer review in parallel to the public comment period when a Notice of Proposed Rulemaking to add a health condition to the List is published in the Federal Register.

The Administrator appreciates the recommendations made by the GAO and will continue to use their findings to improve the WTCHP.

Paul J. Middendorf, PhD, CIH

Dr. Middendorf is a Senior Advisor in the NIOSH Office of the Director.