2024-20540. World Trade Center (WTC) Health Program; Expanded Eligibility for Pentagon and Shanksville, Pennsylvania Responders

Table 1—Projected Annual New Pentagon and Shanksville Responder Enrollments Under Expanded Eligibility Criteria, FY2024-2028

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.

Table 2—Projected Enrollment and Associated Medical and Pharmacy Costs for Current Pentagon and Shanksville Responders, FY2024-2028

[2024$]

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.

Table 3—Projected Medical and Pharmacy Costs per Current Pentagon and Shanksville Responder Member, FY2024-2028

[2024$]

FY	Projected medical costs per member	Projected pharmacy costs per member	Total projected cost per member
2024	$2,201	$1,238	$3,439
( print page 73598)
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.

Table 4—Projected Medical and Pharmacy Costs, New Pentagon and Shanksville Responders Under Expanded Eligibility Criteria, FY2024-2028

[2024$]

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.

Table 5—Total Projected Medical and Pharmacy Costs, New Pentagon and Shanksville Responders Under Expanded Eligibility Criteria, FY2024-2028

[2024$]

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.

Benefits

The Administrator of the WTC Health Program does not have information on the health of the population that may ( print page 73599) have experienced 9/11 exposures and is not currently enrolled in the WTC Health Program. In addition, the Administrator has only limited information about health insurance and healthcare services available for WTC-related health conditions potentially caused by 9/11 exposures and suffered by any population of responders and survivors who are not currently enrolled. For the purposes of this analysis, the Administrator assumed that all unenrolled responders and survivors are now covered by health insurance due to access provided by the Patient Protection and Affordable Care Act and may be receiving treatment outside the WTC Health Program.

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.

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 [e-mail].

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.

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. ( print page 73600)

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