World Trade Center (WTC) Health Program; Expanded Eligibility for Pentagon and Shanksville, Pennsylvania Responders

SUPPLEMENTARY INFORMATION:

I. Public Participation

Interested parties may participate in this rulemaking by submitting written views, opinions, recommendations, and data. Comments received, including attachments and other supporting materials, are part of the public record and subject to public disclosure. Any information in comments or supporting materials that is confidential or not intended to be disclosed should not be included. CDC will consider the comments submitted and may revise the final rule as appropriate.

II. Background

Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 (Zadroga Act), as amended, revised the Public Health Service Act (PHS Act) to establish the WTC Health Program (Program), which is administered by the National Institute for Occupational Safety and Health (NIOSH), within CDC. The WTC Health Program provides medical monitoring and treatment to eligible responders to the September 11, 2001, terrorist attacks in New York City, at the Pentagon, and in Shanksville, Pennsylvania, and to eligible survivors of the New York City attacks.

In this interim final rule, the Administrator of the WTC Health Program and the Secretary of HHS revise the implementing regulation for the Program in a limited manner to only align with the statutory changes to the PHS Act. Specifically, the revisions made by this rulemaking include expanding eligibility criteria for Pentagon and Shanksville responders, adding a numerical limit on Pentagon and Shanksville responders enrolled under the new eligibility criteria, updating the language in the regulation regarding the numerical limit on certain newly enrolled WTC responders and certified-eligible survivors, and updating and adding definitions into the WTC Health Program regulations in 42 CFR part 88.

A. WTC Health Program Statutory Authority

Title I of the Zadroga Act (Pub. L. 111-347, as amended by Pub. L. 114-113, Pub. L. 116-59, Pub. L. 117-328, and Pub. L. 118-31) added Title XXXIII to the PHS Act, codified at 42 U.S.C. 300mm-300mm-64, establishing the WTC Health Program within HHS. The WTC Health Program provides medical monitoring and treatment benefits to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery, and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, at the Pentagon, and in Shanksville, Pennsylvania (responders), and to eligible persons who were present in the dust or dust cloud on September 11, 2001, or who worked, resided, or attended school, childcare, or adult daycare in the New York City disaster area (survivors).

All references to the Administrator in this document mean the Director of NIOSH, within CDC, or his or her designee.

B. Regulatory Background

Following the enactment of the Zadroga Act, the HHS Secretary promulgated 42 CFR part 88 to establish the WTC Health Program within NIOSH. The Zadroga Act prescribed eligibility criteria for Pentagon and Shanksville, Pennsylvania responders and required the Administrator to establish the dates on which cleanup was concluded at the Pentagon and Shanksville sites, respectively. The Administrator promulgated the eligibility criteria and cleanup dates in 42 CFR 88.4(b) and (c) through a rulemaking published on March 28, 2013. Following the rulemaking, eligible Pentagon and Shanksville responders include those individuals who:

• Were active or retired members of a fire or police department (fire or emergency personnel), worked for a recovery or cleanup contractor, or were volunteers; and
• Performed rescue, recovery, demolition, debris cleanup, or other related services, either at the Pentagon site of the September 11, 2001, terrorist attacks, for at least 1 day beginning September 11, 2001, and ending on November 19, 2001, or at the Shanksville, Pennsylvania site for at least 1 day beginning September 11, 2001, and ending on October 3, 2001.

Since 2013, the WTC Health Program has enrolled 1,304 Pentagon responders and Shanksville, Pennsylvania responders, combined. In 2023, Congress identified a gap in coverage for the population of employees of the Department of Defense (DOD) or other Federal agencies, certain DOD and Federal agency contractors, and regular or reserve uniformed service members who responded to the Pentagon and Shanksville sites; these personnel have previously not met the statutory eligibility criteria in the Zadroga Act due to their specific types of employment.

C. Need for Rulemaking

The National Defense Authorization Act, 2024 (Pub. L. 118-31, December 22, 2023) (2024 NDAA) amended Title XXXIII of the PHS Act to expand eligibility criteria for responders to the September 11, 2001, terrorist attacks at the Pentagon and in Shanksville, Pennsylvania. The new statutory criteria for both sites establish eligibility criteria for an individual who:

• was an employee of the DOD or any other Federal agency,
• worked during the period beginning on September 11, 2001, and ending on September 18, 2001, for a contractor of the DOD or any other Federal agency, or
• was a member of a regular or reserve component of the uniformed services.

Such individuals must have “performed rescue, recovery, demolition, debris cleanup, or other related services” during the respective cleanup periods at the Pentagon or Shanksville, Pennsylvania sites.

The 2024 NDAA amendments also define the terms Federal agency and uniformed services. A Federal agency is “[a]n agency, office, or other establishment in the executive, legislative, or judicial branch of the Federal Government.” The uniformed services are “the armed forces; the commissioned corps of the National Oceanic and Atmospheric Administration; and the commissioned corps of the Public Health Service.”

In addition to the expanded eligibility criteria, the 2024 NDAA amendments direct that the total number of Pentagon or Shanksville responders who may be enrolled pursuant to the expanded eligibility criteria is limited to 500 individuals at any time and excludes these responders from the numerical limitations for newly enrolled responders. Previous amendments to Title XXXIII (Continuing Appropriations Act, 2020, and Health Extenders Act of 2019, Pub. L. 116-59, September 27, 2019) increased the numerical limitations for newly enrolled WTC responders and certified-eligible WTC survivors enrolled pursuant to the original eligibility criteria from 25,000 to 75,000 each.

In order to operationalize the 2024 NDAA amendments, this rulemaking adds the new statutory definitions of the terms Federal agency and uniformed services to the existing definitions in 42 CFR 88.1; expands existing Pentagon and Shanksville, Pennsylvania eligibility criteria in § 88.4(b) and (c), respectively; and adds a numerical limit for the new population of Pentagon and Shanksville responders to § 88.6(c)(2)(ii). Without making these changes to part 88, it would not be possible for these responders to enroll and participate in the WTC Health Program.

This rulemaking also makes conforming changes to align part 88 with the Zadroga Act, as amended by the Continuing Appropriations Act, 2020, and Health Extenders Act of 2019. The numerical limits for certain newly enrolled WTC responders and certified-eligible WTC survivors in §§ 88.6(c)(2)(i) and 88.12(b)(3)(i), respectively, are replaced with language indicating that the number of responders or certified-eligible survivors established may not exceed the limit established in the Act. Because the statutory limits were raised in 2019 and immediately went into effect, this change is considered non-substantive and will not result in any regulatory impact. The existing definitions of the terms Act and WTC Health Program are also revised to update the statutory references.

D. Issuance of Interim Final Rule With Immediate Effective Date

Rulemaking is required to update WTC Health Program regulations to reflect the 2024 NDAA amendments expanding those groups eligible for enrollment as responders at the Pentagon and Shanksville, Pennsylvania sites. Once the expanded eligibility criteria are added to 42 CFR part 88, the WTC Health Program can begin accepting applications from those individuals who may qualify for the Program. HHS has determined that an interim final rule, rather than a notice of proposed rulemaking, is appropriate in this instance to ensure the new eligibility criteria expanding enrollment for responders at the Pentagon and Shanksville sites may be implemented as soon as possible.

Moreover, the rulemaking will implement statutory changes required by the 2024 NDAA, expanding eligibility as provided by statutory changes without exercising discretion or otherwise interpreting statutory provisions. As described above, the 2024 NDAA established new criteria for responders to the September 11, 2001, terrorist attacks at the Pentagon and in Shanksville, Pennsylvania. The NDAA also established definitions for the terms Federal agency and uniformed services. Finally, the NDAA included a numerical limit of 500 members on Pentagon and Shanksville responders enrolled under the new eligibility criteria. In this rulemaking, the new statutory criteria for Pentagon and Shanksville responders are added to part 88 as are the definitions of the terms Federal agency and uniformed services. Similarly, the statutory cap of 500 Pentagon and Shanksville members is also added to part 88. This rulemaking does not deviate from language in the 2024 NDAA.

Under the Administrative Procedure Act (APA), prior notice and comment on a rulemaking may be dispensed with if there is good cause to believe that such procedures would be “impracticable, unnecessary, or contrary to the public interest.” In this case, the agency believes there is good cause to waive prior public participation because such procedures are largely unnecessary and would be contrary to the public interest in expanding services to certain responders to the September 11, 2001, terrorist attacks.

The rulemaking will implement statutory changes required by the 2024 NDAA and opposition to the expanded eligibility requirements is not anticipated. The 2024 NDAA signed into law included language expanding eligibility for the WTC Health Program to additional responders at the Pentagon and Shanksville sites. The newly eligible responders include employees of DOD or other Federal agencies, certain DOD and Federal agency contractors, and regular or reserve members of the uniformed services. Specifically, the NDAA provided additional eligibility for:

[A]n employee of the Department of Defense or any other Federal agency, worked during the period beginning on September 11, 2001, and ending on September 18, 2001, for a contractor of the Department of Defense or any other Federal agency, or was a member of a regular or reserve component of the uniformed services; and performed rescue, recovery, demolition, debris cleanup, or other related services at the Pentagon site of the terrorist-related aircraft crash of September 11, 2001, during the period beginning on September 11, 2001, and ending on the date on which the cleanup of the site was concluded, as determined by the WTC Program Administrator; or

[A]n employee of the Department of Defense or any other Federal agency, worked during the period beginning on September 11, 2001, and ending on September 18, 2001, for a contractor of the Department of Defense or any other Federal agency, or was a member of a regular or reserve component of the uniformed services; and performed rescue, recovery, demolition, debris cleanup, or other related services at the Shanksville, Pennsylvania, site of the terrorist-related aircraft crash of September 11, 2001, during the period beginning on September 11, 2001, and ending on the date on which the cleanup of the site was concluded, as determined by the WTC Program Administrator.

The NDAA also caps the number of new Pentagon and Shanksville responders at 500. The rulemaking will only implement statutory changes enacted by the NDAA, expanding eligibility as provided by statutory changes without exercising discretion or otherwise interpreting statutory provisions. As described above, the rulemaking would add categories of DOD and other Federal employees and contractors and uniformed service members who may be eligible for the WTC Health Program and also incorporate the statutory limit on the number of additional responders who would be eligible. There is no deviation or addition from the statutory language in the regulatory text.

It would be contrary to the public interest to delay any longer than necessary these individuals' eligibility for treatment of health conditions that are found to be related to their 9/11 response activities. Postponement of the implementation of the new eligibility criteria could result in harm to Pentagon and Shanksville responders currently coping with one or more health conditions covered by the WTC Health Program or who are at risk for developing such a condition. Thus, notice and comment procedures should be waived in the interest of protecting the health of these responders and allowing them to apply for enrollment in the WTC Health Program as soon as possible. No opposition to the expanded eligibility requirements is anticipated and the agency will not be exercising any discretion in further defining certain employees who may be eligible for the Program or clarifying any additional limits on the number of individuals from these categories who would be eligible. The 2024 NDAA established a new and distinct fund to specifically pay for medical monitoring and treatment for this new group of responders, thereby accounting for the anticipated costs associated with the expansion. Because this interim final rule does not seek to deviate from the 2024 NDAA language and because no opposition to this rulemaking is expected, the agency finds that notice-and-comment rulemaking is unnecessary and contrary to the public interest.

The APA also requires the publication of a rule “not less than 30 days before its effective date,” unless the agency finds and publishes with the rule good cause for such exception. The same standard for establishing “good cause” applies to both excepting a rulemaking from notice and comment requirements and excepting a rulemaking from the 30-day post-publication effective date requirement. The “impracticable” and “contrary to the public interest” prongs of the good-cause exemption are also satisfied here with respect to waiving the requirement for a 30-day post-publication effective date. As elaborated further below, the typical delayed effective date would defer the agency's ability to provide life-saving treatment and result in less favorable outcomes and survival rates for covered individuals. The agency expects that Program members who have certified WTC-related health conditions experience better treatment outcomes with Program physicians as compared with receiving care outside of the Program, because of the expertise of Program physicians. Moreover, while other insurance plans may require deductibles and copays, which impact access to timely care, WTC Health Program members have first-dollar coverage and thus may seek care sooner, resulting in improved treatment outcomes. Additionally, the “unnecessary” prong of the good-cause exemption is satisfied because the enactment of the 2024 NDAA provided interested parties notice of the changes to the eligibility criteria; thus, a delayed effective date is not needed to allow interested parties to ready for implementation of the rule.

The purpose of the typical post-publication waiting period is to give affected parties time to adjust their behavior before the final rule takes effect. In this instance, however, the affected parties are prospective members of the WTC Health Program who have waited decades for medical monitoring and treatment of their WTC-related health conditions. The Program anticipates that many prospective members will submit applications for enrollment as soon as this rule is effective. Such prospective members are already on notice of the statutory changes enacted in the 2024 NDAA, and this regulation implements such statutory changes without exercising discretion or otherwise interpreting statutory provisions. Thus, such prospective members do not require an additional 30 days to ready themselves for implementation of this rule. Indeed, any delay in effective date could result in postponed medical care for such members or require them to pay out of pocket for care in the interim. Delayed implementation of the expanded eligibility criteria could result in real harm to Pentagon and Shanksville responders currently coping with one or more health conditions covered by the WTC Health Program or who are at risk for developing such conditions. It is in these prospective members' best interest that they receive treatment for their WTC-related health conditions as soon as possible. Thus, the 30-day post-publication effective date is waived for the benefit of these responders to allow them to apply for enrollment in the WTC Health Program as soon as possible.

Moreover, the WTC Health Program does not require additional time to prepare for the implementation of this rule. As such, there is no public interest served in further delaying the effective date of this rulemaking. Public comments on the interim final rule will be considered by the Administrator and the regulatory text may be modified, as necessary.

Because it would be contrary to the public interest to delay any longer than necessary these individuals' eligibility for treatment of health conditions that are found to be related to their 9/11 response activities, the Administrator of the WTC Health Program and the HHS Secretary find that good cause exists to waive the notice and comment requirement and make this rulemaking effective immediately on publication. Public comments on the interim final rule will be considered by HHS and the Administrator prior to issuance of a final rule and the regulatory text may be modified to address comments, as necessary. Issuance of a final rule will be noticed in the Federal Register .

III. Summary of Final Rule

With this rulemaking, 42 CFR part 88 is amended as described below.

Authority Citation

The authority citation for 42 CFR part 88 is updated to reflect recent amendments to Title I of the Zadroga Act (Pub. L. 111-347, as amended by Pub. L. 114-113, Pub. L. 116-59, Pub. L. 117-328, and Pub. L. 118-31). The statutory citation now reads 42 U.S.C. 300mm-300mm-64.

Section 88.1 Definitions

The statutory definitions of the terms Federal agency and uniformed services are added to the existing Definitions section, 42 CFR 88.1. In the existing definitions of Act and WTC Health Program, the statutory authority is updated to reflect recent amendments to the Zadroga Act.

Section 88.4 Eligibility Criteria—WTC Responders

The existing Pentagon responder eligibility criteria in 42 CFR 88.4(b) are modified to include the new statutory criteria for the three new classes of eligible responders at the Pentagon site. For clarity, the existing language in paragraph (b)(1) is broken into new paragraphs, designated (b)(1)(i) through (iii). New paragraph (b)(1)(iv) identifies employees of the DOD or any other Federal agency; paragraph (b)(1)(v) identifies employees of DOD contractors or other Federal agency contractors who worked during the period beginning on September 11, 2001, and ending on September 18, 2001; and paragraph (b)(1)(vi) identifies members of regular and reserve components of the uniformed services. Language in existing § 88.4(b)(2) describing eligible response activities, time periods, and duration of work is split into two paragraphs, resulting in a new paragraph (b)(3).

The existing Shanksville, Pennsylvania responder eligibility criteria in § 88.4(c) are also revised to add the new statutory criteria for the three new classes of eligible responders at the Shanksville, Pennsylvania site. For clarity, the existing language in paragraph (c)(1) is broken into new paragraphs, designated (c)(1)(i) through (iii). New paragraph (c)(1)(iv) identifies employees of the DOD or any other Federal agency; paragraph (c)(1)(v) identifies employees of DOD contractors or other Federal agency contractors who worked during the period beginning on September 11, 2001, and ending on September 18, 2001; and paragraph (c)(1)(vi) identifies members of regular and reserve components of the uniformed services. Language in existing paragraph (c)(2) describing eligible response activities, time periods, and duration of work is split into two paragraphs, resulting in a new paragraph (c)(3).

Section 88.6 Enrollment Decision—WTC Responders

In 42 CFR 88.6, existing paragraph (c) establishes conditions under which the WTC Health Program may deny enrollment of responders. In paragraph (c)(2)(i), the numerical limit on new WTC responder enrollment is replaced with new language indicating that this limit is established in the Zadroga Act, as amended. Language in paragraph (c)(2)(i) describing the Administrator's discretion regarding whether to close Program enrollment in the event that sufficient funds are not available to enroll new members is moved to a new paragraph (c)(2)(iii) without change. New text in paragraph (c)(2)(ii) reflects the new statutory limit of 500 total WTC responders who may be enrolled pursuant to the expanded Pentagon and Shanksville, Pennsylvania eligibility criteria in §§ 88.4(b)(1)(iv) through (vi) and 88.4(c)(1)(iv) through (vi), respectively.

Section 88.12 Enrollment Decision—Certified-Eligible Survivors

In 42 CFR 88.12, existing paragraph (b)(3) establishes conditions under which the WTC Health Program may deny certified-eligible survivor status. The numerical limit in paragraph (b)(3)(i) is replaced with new language indicating that the limit on certified-eligible survivor enrollment is specified in the Zadroga Act, as amended. Language in existing paragraph (b)(3)(i), describing the Administrator's discretion regarding whether to close Program enrollment in the event that sufficient funds are not available to enroll new members, is moved to a new paragraph (b)(3)(ii) without change.

IV. Regulatory Impact Analysis

A. Executive Order 12866 (Regulatory Planning and Review), Executive Order 13563 (Improving Regulation and Regulatory Review), and Executive Order 14094 (Modernizing Regulatory Review)

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 14094 entitled “Modernizing Regulatory Review” amends section 3(f)(1) of Executive Order 12866 (Regulatory Planning and Review). The amended section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule: (1) having an annual effect on the economy of $200 million or more (adjusted every 3 years by the Administrator of the Office of Management and Budget's Office of Information and Regulatory Affairs (OIRA) for changes in gross domestic product), or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or Tribal governments or communities; (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising legal or policy issues for which centralized review would meaningfully further the President's priorities or the principles set forth in this Executive order, as specifically authorized in a timely manner by the Administrator of OIRA in each case. A regulatory impact analysis (RIA) must be prepared for major rules with significant regulatory action/s and/or with significant effects as per section 3(f)(1) ($200 million or more in any 1 year).

This interim final rule has been determined not to be a significant regulatory action under section 3(f)(1) of Executive Order 12866 and does not meet the criteria set forth in 5 U.S.C. 804(2) under subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (also known as the Congressional Review Act). This rulemaking expands the existing eligibility criteria for the enrollment of Pentagon and Shanksville responders to also include employees of the DOD or any other Federal agency, certain DOD and Federal agency contractors, and regular or reserve members of the uniformed services who meet the activity, location, and time criteria specified in the statutory amendments. The rulemaking implements the statutory cap of 500 on the total number of Pentagon and Shanksville responders enrolled under those expanded criteria.

The 2024 NDAA allows for the addition of up to 500 new Program members to be enrolled under the expanded eligibility criteria for individuals who responded to the September 11, 2001, terrorist attack sites at the Pentagon in Arlington, Virginia, and in Shanksville, Pennsylvania, pursuant to 42 U.S.C. 300mm-21(a)(4)(A)(ii). In accordance with sec. 300mm-64(c)(1), costs associated with carrying out medical monitoring, diagnostics, screening, and treatment, including non-pharmacy and pharmacy costs, for the 500 new members are to be paid out of a newly established World Trade Center Health Program Fund for Certain WTC Responders at the Pentagon and Shanksville, Pennsylvania. For that reason, this analysis accounts only for those costs associated with medical monitoring, diagnostics, screening, and non-pharmacy treatment (medical costs) and pharmacy costs; WTC Health Program administrative costs are not included in the analysis.

Historical WTC Health Program claims data were used to project the costs associated with the future enrollment of 500 potential new Pentagon and Shanksville responder members under the expanded eligibility criteria. These historical data account for variables including an aging member population, healthcare utilization, co-morbidities, and inflation; incorporation of these variables results in projected per-member costs increasing year-over-year.

This analysis started from the premise that all 500 future Pentagon and Shanksville members will enroll in the Program within 5 years of this rulemaking. To estimate the rate of enrollment over 5 years, this analysis further assumed that fiscal year (FY) 2024 enrollment will be relatively low, given the timing of this rulemaking. New enrollments could peak in the first and second full fiscal years (FY2025/2026 if enrollment starts in FY2024) and likely level off in later years. Given these assumptions, the new enrollments for this group were estimated for each fiscal year from FY2024 through FY2028; after the FY2024 estimate, each subsequent annual estimate was then added to the enrollment from the prior fiscal year to estimate the total number of members in the expanded eligibility category for each fiscal year in table 1.