View Rule

With this rulemaking, HHS/CDC proposes to add uterine cancer to the List of WTC-Related Health Conditions.

Overall Description of Deadline: Authorizing statute requires publication of a rulemaking in the Federal Register not later than 90 days after receipt of advisory committee recommendation.

Statement of Need:

Uterine cancer is the only type of cancer not included on the List of WTC-Related Health Conditions (List) eligible for coverage by the WTC Health Program. Following requests from WTC responders and survivors, as well as a letter from five WTC Health Program Clinical Centers of Excellence requesting the addition of uterine cancer to the List, the Program reviewed the available scientific evidence of an association between uterine cancer and 9/11 exposures in accordance with the WTC Health Program’s Policy and Procedures for Adding Cancers to the List of WTC-Related Health Conditions . The disproportionately low representation of women in the most studied cohorts of exposed responders makes it unlikely that a definitive association between toxic exposure arising from the September 11, 2001, terrorist attacks and the occurrence of uterine cancer will be identified during the lifetimes of most WTC Health Program members.

The Administrator of the WTC Health Program exercised discretion to seek a recommendation from the Program’s Scientific/Technical Advisory Committee (STAC) and asked the STAC to review the available scientific evidence concerning potential associations between 9/11 exposures and uterine cancer. During public meetings, the STAC considered public comments and deliberated on whether there is a reasonable basis to recommend the addition of uterine cancer to the List, ultimately providing the Administrator with its recommendation and rationale for the addition. Based on the STAC’s recommendation and the Program’s evaluation of the available scientific literature, the Administrator determined that there is a sufficient evidentiary basis to propose the addition of uterine cancer to the List. This action will promote equity for Program members who are found to have WTC-related uterine cancer.

Summary of the Legal Basis:

Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 amended the Public Health Service (PHS) Act to establish the WTC Health Program within HHS. See 42 U.S.C. 300mm to 300mm61. The WTC Health Program provides medical monitoring and treatment benefits to eligible responders to the September 11, 2001, terrorist attacks in New York City, at the Pentagon, and in Shanksville, Pennsylvania (responders), and eligible survivors in the New York City disaster area (survivors). Treatment is available under the Program for specified health conditions included on the List. Section 3312(a)(6) of the PHS Act requires the Administrator of the WTC Health Program to conduct rulemaking to propose the addition of a health condition to the List codified in 42 CFR 88.15.

Alternatives:

If the WTC Health Program did not add uterine cancer to the List of WTC-Related Health Conditions, current and future WTC Health Program members who have or develop uterine cancer likely related to 9/11 exposures will not be eligible to receive treatment services from the Program.

Anticipated Costs and Benefits:

This final rulemaking is estimated to cost the WTC Health Program between $1,718,691 and $3,617,447 per annum for 2022-2025. Due to the implementation of provisions of the Patient Protection and Affordable Care Act and as required under the authorizing statute for the WTC Health Program, all of the members and future members are assumed to have or have access to medical insurance coverage other than through the WTC Health Program. Therefore, all treatment costs to be paid by the WTC Health Program are considered transfer payments. This final rulemaking will not impose costs on Program members or any other interested party.

WTC Health Program members with certified WTC-related uterine cancer are expected to experience better treatment outcomes with Program physicians as compared to receiving care outside of the Program. Members may experience higher survival rates compared with those not enrolled and have improved access to timely care, which is associated with improved treatment outcomes.

Risks:

The WTC Health Program may be perceived as a policy decision as a result of this rulemaking because the science informing proposed additions to the List is limited by incomplete information on 9/11 exposures, health outcomes, and the relationships they share. For example, the exposures experienced by the responders and survivors on and after September 11, 2001 were not measured and can only be estimated. Also, there are relatively few women in the 9/11-exposed populations; therefore, studies lack the statistical power needed to observe a causal association among women with a high degree of certainty. Given incomplete information, some may argue against the sufficiency of the science supporting the addition of uterine cancer to the List.