89 FR 176 pgs. 73592-73601 - World Trade Center (WTC) Health Program; Expanded Eligibility for Pentagon and Shanksville, Pennsylvania Responders
Type: RULEVolume: 89Number: 176Pages: 73592 - 73601
Pages: 73592, 73593, 7359473595, 73596, 73597, 73598, 73599, 73600, 73601, Docket number: [Docket No. CDC-2024-0067; NIOSH-353]
FR document: [FR Doc. 2024-20540 Filed 9-10-24; 8:45 am]
Agency: Health and Human Services Department
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 88
[Docket No. CDC-2024-0067; NIOSH-353]
RIN 0920-AA86
World Trade Center (WTC) Health Program; Expanded Eligibility for Pentagon and Shanksville, Pennsylvania Responders
AGENCY:
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
ACTION:
Interim final rule.
SUMMARY:
This interim final rule updates existing regulations governing the WTC Health Program, which provides medical monitoring and treatment 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, and to eligible survivors of the New York City attacks. This rulemaking expands existing eligibility criteria for enrollment of new Pentagon and Shanksville responders, caps those new members at 500, and makes various conforming amendments to the WTC Health Program regulations to align with statutory changes.
DATES:
This interim final rule will be effective September 11, 2024. The WTC Health Program invites written comments from interested parties on this interim final rule and on the information collection approval request sought under the Paperwork Reduction Act. Comments must be received by October 11, 2024.
ADDRESSES:
Written comments: Comments, including those related to the Paperwork Reduction Act, may be submitted by any of the following methods:
• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments to the docket.
[top] • Mail: NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 1090
Instructions: All submissions received must include the agency name (Centers for Disease Control and Prevention, HHS) and docket number (CDC-2024-0067; NIOSH-353) or Regulation Identifier Number (0920-AA86) for this rulemaking. All relevant comments, including any personal information provided, will be posted without change to https://www.regulations.gov. Do not submit comments by email. CDC does not accept comments by email. For detailed instructions on submitting public comments, see the "Public Participation" heading of the SUPPLEMENTARY INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT:
Rachel Weiss, Public Health Analyst, National Institute for Occupational Safety and Health, 1090 Tusculum Avenue, MS: C-46, Cincinnati, OH 45226; telephone: (404) 498-2500 (this is not a toll-free number); email: NIOSHregs@cdc.gov.
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? 1 (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).
Footnotes:
1 ?Those portions of the Zadroga Act found in titles II and III of Public Law 111-347 do not pertain to the WTC Health Program and are codified elsewhere.
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. 2 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. 3 Following the rulemaking, eligible Pentagon and Shanksville responders include those individuals who:
Footnotes:
2 ?42 U.S.C. 300mm-21(a)(2)(C)(i)(I) and (II).
3 ? World Trade Center Health Program Eligibility Requirements for Shanksville, Pennsylvania and Pentagon Responders, Interim Final Rule, 78 FR 18855, March 28, 2013.
• 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. 4
Footnotes:
4 ?42 U.S.C. 300mm-21(a)(2)(C)(i)(III) and (IV).
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. 5
Footnotes:
5 ?The Administrator previously determined that the cleanup period at the Pentagon site concluded on November 19, 2001; the cleanup period at the Shanksville, Pennsylvania site was determined to have concluded on October 3, 2001. 78 FR 18855, March 28, 2013; World Trade Center Health Program; Amendments to Definitions, Appeals, and Other Requirements, Final Rule, 81 FR 90926, December 15, 2016.
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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."? 6 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."? 7
Footnotes:
6 ?42 U.S.C. 300mm-5(5).
7 ?42 U.S.C. 300mm-5(13) adopting by reference the definition at 10 U.S.C. 101(a).
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? 8 and excludes these responders from the numerical limitations for newly enrolled responders. 9 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? 10 from 25,000 to 75,000 each.
Footnotes:
8 ?42 U.S.C. 300mm-21(a)(4)(A)(ii).
9 ?42 U.S.C. 300mm-21(a)(4)(A)(i).
10 ?For purposes of the numerical limitation, eligibility criteria for WTC responders are those newly enrolled responders identified in 42 U.S.C. 300mm-21(a)(1)(B)-(C), except FDNY family members and the new categories of Pentagon and Shanksville responders added by the 2024 NDAA. 42 U.S.C. 300mm-21(a)(4)(A)(i). The numerical limitation for certified-eligible WTC survivors applies to those newly enrolled survivors identified in 42 U.S.C. 300mm-31(a)(1)(A)(ii)-(iii) and certified with a WTC-related health condition pursuant to 42 U.S.C. 300mm-31(a)(2)(B).
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."? 11 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.
Footnotes:
11 ?5 U.S.C. 553(b)(B). Courts differ on whether the good cause standard for waiving notice and comment announced in sec. 553(b)(B) of the APA is the same standard that should be applied in waiving the 30-day publication rule in sec. 553(d). See Cole JP [Jan 2016], The Good Cause Exception to Notice and Comment Rulemaking: Judicial Review of Agency Action, Congressional Research Service, No. R44356 at 3-4 (noting that some courts have indicated that these are two distinct standards and that the test for good cause to waive notice and comment is more stringent than that used to waive the 30-day rule).
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. 12
Footnotes:
12 ?Public Law 118-31, div. A, title XVIII, 1851; 137 Stat. 706, 708.
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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, 13 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.
Footnotes:
13 ?42 U.S.C. 300mm-64.
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. 14 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.
Footnotes:
14 ?5 U.S.C. 553(d).
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
[top] The existing Pentagon responder eligibility criteria in 42 CFR 88.4(b) are modified to include the new statutory
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.
[top] 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
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.
| FY | Projected new enrollment | Cumulative new enrollment |
|---|---|---|
| 2024 | 30 | 30 |
| 2025 | 150 | 180 |
| 2026 | 120 | 300 |
| 2027 | 100 | 400 |
| 2028 | 100 | 500 |
| Total | 500 |
The Program next estimated the future annual medical and pharmacy costs associated with 500 new Pentagon and Shanksville responder members enrolled over 5 years, from FY2024 through FY2028. This analysis assumed that individuals enrolled under the expanded eligibility criteria would have similar average medical costs and pharmacy costs as Pentagon and Shanksville responders enrolled under the current eligibility criteria. This analysis does not include administrative costs associated with the addition of future members.
To estimate the future costs associated with the enrollment of 500 new members, this analysis first found the average per-member medical costs, pharmacy costs, and total costs for Pentagon and Shanksville responders enrolled under the current eligibility criteria. To do so, first, future enrollment and annual medical costs, pharmacy costs, and total costs were projected for the current Pentagon and Shanksville responders through FY2028. See table 2.
| FY | Total projected number of Pentagon/Shanksville responders, current eligibility criteria | Projected total medical costs | Projected total pharmacy costs | Total projected costs |
|---|---|---|---|---|
| 2024 | 1,391 | $3,061,444 | $1,722,479 | $4,783,923 |
| 2025 | 1,513 | 3,547,280 | 1,966,896 | 5,514,176 |
| 2026 | 1,636 | 4,033,115 | 2,211,313 | 6,244,428 |
| 2027 | 1,758 | 4,518,950 | 2,455,731 | 6,974,681 |
| 2028 | 1,880 | 5,004,785 | 2,700,148 | 7,704,933 |
| Total | 20,165,574 | 11,056,567 | 31,222,141 |
Next, the projected medical costs and projected pharmacy costs were divided by the projected number of Pentagon and Shanksville responder members under the current eligibility criteria (table 2) to calculate the estimated average per member medical costs and pharmacy costs for each projected year from FY2024 through FY2028. The total cost per member was then calculated by summing the per member medical and pharmacy costs for each fiscal year. See table 3.
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| FY | Projected medical costs per member | Projected pharmacy costs per member | Total projected cost per member |
|---|---|---|---|
| 2024 | $2,201 | $1,238 | $3,439 |
| 2025 | 2,345 | 1,300 | 3,645 |
| 2026 | 2,465 | 1,352 | 3,817 |
| 2027 | 2,571 | 1,397 | 3,968 |
| 2028 | 2,662 | 1,436 | 4,098 |
Next, the projected medical costs and pharmacy costs for new Pentagon and Shanksville responders were calculated for FY2024 through FY2028 by multiplying the predicted costs per current Pentagon and Shanksville responder for each fiscal year from table 3 by the projected cumulative number of new members enrolled under the expanded eligibility criteria for each fiscal year from table 1. The analysis concluded that the projected medical and pharmacy costs for 500 Pentagon and Shanksville responders enrolled under the expanded eligibility criteria will be $5,540,570 (undiscounted) over 5 years. See table 4.
| FY | Projected cumulative new enrollment | Projected medical costs for cohort | Projected pharmacy cost for cohort | Projected total cost for cohort |
|---|---|---|---|---|
| 2024 | 30 | $66,030 | $37,140 | $103,170 |
| 2025 | 180 | 422,100 | 234,000 | 656,100 |
| 2026 | 300 | 739,500 | 405,600 | 1,145,100 |
| 2027 | 400 | 1,028,400 | 558,800 | 1,587,200 |
| 2028 | 500 | 1,331,000 | 718,000 | 2,049,000 |
| Total | 3,587,030 | 1,953,540 | 5,540,570 |
The total projected costs associated with the expansion of the Pentagon and Shanksville eligibility criteria for each fiscal year, from table 4, were discounted at the 2 percent rate to reflect changes in the valuation of the impacts of this rulemaking across time. In table 5, the total medical and pharmacy costs were projected to be between $5,132,395 (discounted at 2%) and $5,540,570 (undiscounted) over 5 years. The discounted and undiscounted 5-year totals were divided by 5 to find the projected average annual costs from $1,026,479 (discounted at 2%) to $1,108,144 (undiscounted). The projected total medical and pharmacy costs described here may be overstated if the total number of Pentagon and Shanksville responders enrolled pursuant to the expanded eligibility criteria is fewer than 500 members.
| FY | Undiscounted | Discounted 2% |
|---|---|---|
| 2024 | $103,170 | |
| 2025 | 656,100 | $643,240 |
| 2026 | 1,145,100 | 1,100,670 |
| 2027 | 1,587,200 | 1,495,619 |
| 2028 | 2,049,000 | 1,892,866 |
| Total | 5,540,570 | 5,132,395 |
| Annualized | 1,108,144 | 1,026,479 |
Since the implementation of provisions of the Patient Protection and Affordable Care Act on January 1, 2014, all WTC Health Program members and future members are assumed to have or have had access to medical insurance coverage other than through the WTC Health Program. 15 Therefore, all medical and pharmacy costs to be paid by the WTC Health Program from 2024 through 2028 are considered transfers.
Footnotes:
15 ?42 U.S.C. 300mm-41(c)(3) requires WTC Health Program members to maintain minimum essential insurance coverage.
Benefits
[top] The Administrator of the WTC Health Program does not have information on the health of the population that may
Although the Administrator cannot quantify the benefits associated with the WTC Health Program, members with certified WTC-related health conditions are expected to experience better treatment outcomes with WTC Health Program providers as compared to receiving care outside of the WTC Health Program. A recent study found that firefighters who responded to the September 11, 2001, terrorist attacks, have lower mortality rates compared with firefighters who were not 9/11-exposed. The authors attributed that finding, in part, to the level of care, including comprehensive health monitoring and treatment, provided to WTC Health Program members. 16 Moreover, under other insurance plans, patients would likely have deductibles and copays, which impact access to care and, particularly, its timeliness. 17 WTC Health Program members have first-dollar coverage and hence are likely to seek care sooner, when indicated, resulting in improved treatment outcomes.
Footnotes:
16 ?Singh A, Zeig-Owens R, Cannon M, Webber MP, Goldfarb DG, Daniels RD, Prezant DJ, Boffetta P, Hall CB [2023], All-Cause and Cause-Specific Mortality in a Cohort of WTC-Exposed and Non-WTC-Exposed Firefighters, Occup Environ Med 0:1-7.
17 ?Wharam JF, Galbraith AA, Kleinman KP, Soumerai SB, Ross-Degnan D, Landon BE [2008], Cancer Screening before and after Switching to a High-Deductible Health Plan, Ann Intern Med 148(9):647-655.
Limitations
The analysis presented here was limited by the dearth of verifiable data on the health status of responders and survivors who have yet to apply for enrollment in the WTC Health Program. Because of the limited data, the Administrator is not able to estimate benefits in terms of averted healthcare costs; nor is the Administrator able to estimate indirect costs, such as averted absenteeism, short- and long-term disability, and productivity losses averted due to premature mortality.
Alternatives
The sole alternative to adding the new statutory enrollment eligibility criteria to the regulations in 42 CFR part 88 is to not add the criteria. In the instant case, neither the Administrator of the WTC Health Program nor the HHS Secretary have discretion in this matter because Congress has directed the specific regulatory outcome-the addition of up to 500 new Pentagon and Shanksville responders-in the 2024 NDAA amendments. Without conducting rulemaking, even though the statutory language establishes expanded eligibility criteria for the enrollment of new Pentagon and Shanksville responders, these individuals would not fall within the scope of the WTC Health Program regulations in 42 CFR part 88. Without eligibility criteria specified in part 88, these individuals could not be enrolled as members in the Program and would not be subject to Program regulations and policies.
B. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA), requires each agency to consider the potential impact of its regulations on small entities, including small businesses, small governmental units, and small not-for-profit organizations. Section 605 of U.S.C. title 5 allows an agency to certify a rule, in lieu of preparing an analysis, if the rulemaking is not expected to have a significant economic impact on a substantial number of small entities. The Secretary certifies that this interim final rule has "no significant economic impact upon a substantial number of small entities" within the meaning of the RFA.
C. Paperwork Reduction Act
The Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., requires an agency to invite public comment on, and to obtain Office of Management and Budget (OMB) approval of, any regulation that requires 10 or more people to report information to the agency or to keep certain records. OMB has already approved the information collection and recordkeeping requirements in OMB Control Number 0920-0891, World Trade Center Health Program Enrollment, Petitions, Designated Representative/HIPAA Authorization, and Member Satisfaction (expiration date September 30, 2025). To account for increases in responses and burden associated with this rulemaking without delay, HHS is requesting emergency review and clearance for the updating of the WTC Health Program Pentagon and Shanksville, Pennsylvania, responders' enrollment application form. A description of the relevant regulatory provision is given below with an estimate of the annual reporting burden. Included in the estimate of the annual reporting burden is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information. In compliance with the requirement of 44 U.S.C. 3506(c)(2)(A) for opportunity for public comment on proposed data collection projects, written comments are encouraged on this information collection. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, you may call 404-639-5960; send comments to Jeffrey M. Zirger, 1600 Clifton Road, MS-H21, Atlanta, GA 30333; or send an email to omb@cdc.gov.
Comments are invited on the following: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information shall have practical utility; (b) the accuracy of the Agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents. Written comments should be received within 30 days of the publication of this document.
[top] This interim final rule allows the WTC Health Program to extend membership to individuals who meet the expanded eligibility criteria codified in 42 CFR 88.4 by this rulemaking. The Program has revised the existing Pentagon/Shanksville eligibility application to include the expanded criteria and is increasing the burden in the approved collection of information to account for up to 500 additional enrollment applications. This emergency information collection request is for 250 annual burden hours.
| Section | Title | Number of respondents | Average responses per respondent | Average burden per response (hr) | Total burden (hr) |
|---|---|---|---|---|---|
| §?88.4 | World Trade Center Health Program Pentagon/Shanksville Responder Application for Enrollment | 500 | 1 | 0.5 | 250 |
The agency will submit the adjustment in burden for OMB Control No. 0920-0891 to OMB for its emergency review and approval.
D. Unfunded Mandates Reform Act of 1995
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1531 et seq. ) directs agencies to assess the effects of Federal regulatory actions on State, local, and Tribal governments, and on the private sector "other than to the extent that such regulations incorporate requirements specifically set forth in law." Section 202 of U.S.C. title 2 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2024, that threshold is approximately $183 million. This interim final rule does not mandate any requirements for State, local, or Tribal governments, or for the private sector, and this rule does not impose a mandate that will result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of more than $183 million in any 1 year.
E. Executive Order 12988 (Civil Justice Reform)
This interim final rule has been drafted and reviewed in accordance with Executive Order 12988 and will not unduly burden the Federal court system. This interim final rule has been reviewed carefully to eliminate drafting errors and ambiguities.
F. Executive Order 13132 (Federalism)
HHS has reviewed this interim final rule in accordance with Executive Order 13132 regarding federalism and has determined that it does not have "federalism implications." The rule does not "have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government."
G. Executive Order 13045 (Protection of Children From Environmental Health Risks and Safety Risks)
In accordance with Executive Order 13045, HHS has evaluated the environmental health and safety effects of this interim final rule on children. HHS has determined that the interim final rule has no environmental health and safety effect on children.
H. Executive Order 13211 (Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use)
In accordance with Executive Order 13211, HHS has evaluated the effects of this interim final rule on energy supply, distribution, or use, and has determined that the rule will not have a significant adverse effect.
I. Plain Writing Act of 2010
Under the Plain Writing Act of 2010, 5 U.S.C. 301 note, executive Departments and Agencies are required to use plain language in documents that explain to the public how to comply with a requirement the Federal Government administers or enforces. HHS has attempted to use plain language in issuing this rulemaking consistent with the Federal Plain Writing Act guidelines but notes that these standards are technical in nature.
List of Subjects in 42 CFR Part 88
Aerodigestive disorders, Appeal procedures, Cancer, Eligibility criteria, Health care, Mental health conditions, Musculoskeletal disorders, Respiratory and pulmonary diseases, World Trade Center.
For the reasons discussed in the preamble, the Administrator and HHS Secretary amend 42 CFR part 88 as follows:
PART 88-WORLD TRADE CENTER HEALTH PROGRAM
1. The authority citation for part 88 is revised to read as follows:
Authority:
42 U.S.C. 300mm to 300mm-64.
2. Amend §?88.1 by:
a. Revising the definition for "Act";
b. Adding the definitions for "Federal agency" and "Uniformed services" in alphabetical order; and
c. Revising the definition for "WTC Health Program".
The revisions and additions read as follows:
§?88.1 Definitions.
Act means Title XXXIII of the Public Health Service Act, as amended, 42 U.S.C. 300mm through 300mm-64 (codifying Title I of the James Zadroga 9/11 Health and Compensation Act of 2010, Pub. L. 111-347, as amended by Pub. L. 114-113, Pub. L. 116-59, Pub. L. 117-328, and Pub. L. 118-31), which created the World Trade Center (WTC) Health Program.
Federal agency means an agency, office, or other establishment in the executive, legislative, or judicial branch of the Federal Government.
Uniformed services means the armed forces, the commissioned corps of the National Oceanic and Atmospheric Administration, and the commissioned corps of the Public Health Service.
WTC Health Program means the program established by Title XXXIII of the Public Health Service Act, as amended, 42 U.S.C. 300mm to 300mm-64 (codifying Title I of the James Zadroga 9/11 Health and Compensation Act of 2010, Pub. L. 111-347, as amended by Pub. L. 114-113, Pub. L. 116-59, Pub. L. 117-328, and Pub. L. 118-31) to provide medical monitoring and treatment benefits for eligible responders to the September 11, 2001, terrorist attacks and initial health evaluation, monitoring, and treatment benefits for residents and other building occupants and area workers in New York City who were directly impacted and adversely affected by such attacks.
3. Amend §?88.4, by revising paragraphs (b) and (c) to read as follows:
§?88.4 Eligibility criteria-WTC responders.
[top] (b) Responders to the Pentagon site of the September 11, 2001, terrorist attacks, may apply for enrollment in the WTC Health Program. Individuals must meet the criteria in paragraphs (b)(1) through (3) of this section to be considered eligible for enrollment.
(1) The individual was one of the following:
(i) An active or retired member of a fire or police department (fire or emergency personnel);
(ii) Worked for a recovery or cleanup contractor;
(iii) A volunteer;
(iv) An employee of the Department of Defense or any other Federal agency;
(v) Worked for a contractor of the Department of Defense or any other Federal agency during the period beginning on September 11, 2001, and ending on September 18, 2001; or
(vi) A member of a regular or reserve component of the uniformed services;
(2) The individual performed rescue, recovery, demolition, debris cleanup, or other related services at the Pentagon site of the September 11, 2001, terrorist attacks; and
(3) The individual performed the activities in paragraph (b)(2) of this section for at least 1 day beginning September 11, 2001, and ending on November 19, 2001.
(c) Responders to the Shanksville, Pennsylvania site of the September 11, 2001, terrorist attacks, may apply for enrollment in the WTC Health Program. Individuals must meet the criteria in paragraphs (c)(1) through (3) of this section to be considered eligible for enrollment:
(1) The individual was one of the following:
(i) An active or retired member of a fire or police department (fire or emergency personnel);
(ii) Worked for a recovery or cleanup contractor;
(iii) A volunteer;
(iv) An employee of the Department of Defense or any other Federal agency;
(v) Worked for a contractor of the Department of Defense or any other Federal agency during the period beginning on September 11, 2001, and ending on September 18, 2001; or
(vi) A member of a regular or reserve component of the uniformed services;
(2) The individual performed rescue, recovery, demolition, debris cleanup, or other related services at the Shanksville, Pennsylvania site of the September 11, 2001, terrorist attacks; and
(3) The individual performed the activities in paragraph (c)(2) of this section for at least 1 day beginning September 11, 2001, and ending on October 3, 2001.
4. Amend §?88.6, by revising paragraph (c)(2) to read as follows:
§?88.6 Enrollment decision-WTC responders.
(c) * * *
(2) The WTC Health Program may deny enrollment of a responder who is otherwise eligible and qualified if the Act's numerical limitations for newly enrolled responders have been met.
(i) No more than the number of WTC responders specified in the Act, as amended, other than those enrolled pursuant to §§?88.3, 88.4(a)(1)(ii), 88.4(b)(1)(iv) through (vi), and 88.4(c)(1)(iv) through (vi), may be enrolled at any time.
(ii) No more than 500 WTC responders meeting the eligibility criteria in §§?88.4(b)(1)(iv) through (vi) and 88.4(c)(1)(iv) through (vi) may be enrolled at any time.
(iii) The Administrator of the WTC Health Program may decide, based on the best available evidence, that sufficient funds are available under the Act to provide treatment and monitoring only for individuals who are already enrolled as WTC responders at that time.
5. Amend §?88.12, by revising paragraphs (b) introductory text and (b)(3) to read as follows:
§?88.12 Enrollment decision-certified-eligible survivors.
(b) The WTC Health Program will review the physician's determination, render a decision regarding certification of the individual's WTC-related health condition, and notify the individual of the decision and the reason for the decision in writing, pursuant to §§?88.17 and 88.18.
(3) The WTC Health Program may deny certified-eligible survivor status of an otherwise eligible and qualified screening-eligible survivor if the Act's numerical limitations for certified-eligible survivors have been met.
(i) No more than the number of individuals specified in the Act, as amended, other than those described in §?88.7, may be determined to be certified-eligible survivors at any time.
(ii) The Administrator of the WTC Health Program may decide, based on the best available evidence, that sufficient funds are available under the Act to provide treatment and monitoring only for individuals who have already been certified as certified-eligible survivors at that time.
John J. Howard,
Administrator, World Trade Center Health Program and Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Department of Health and Human Services.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2024-20540 Filed 9-10-24; 8:45 am]
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