[Federal Register Volume 89, Number 176 (Wednesday, September 11, 2024)]
[Rules and Regulations]
[Pages 73592-73601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-20540]
=======================================================================
-----------------------------------------------------------------------
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.
Mail: NIOSH Docket Office, Robert A. Taft Laboratories,
MS-C34, 1090
[[Page 73593]]
Tusculum Avenue, Cincinnati, OH 45226.
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: [email protected].
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).
---------------------------------------------------------------------------
\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:
---------------------------------------------------------------------------
\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\
---------------------------------------------------------------------------
\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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
[[Page 73594]]
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
\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 Sec. 88.4(b) and (c), respectively; and adds a
numerical limit for the new population of Pentagon and Shanksville
responders to Sec. 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
Sec. Sec. 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.
---------------------------------------------------------------------------
\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\
---------------------------------------------------------------------------
\12\ Public Law 118-31, div. A, title XVIII, 1851; 137 Stat.
706, 708.
[[Page 73595]]
---------------------------------------------------------------------------
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,\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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
\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
The existing Pentagon responder eligibility criteria in 42 CFR
88.4(b) are modified to include the new statutory
[[Page 73596]]
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
Sec. 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 Sec. 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 Sec. Sec. 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
[[Page 73597]]
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.
Table 1--Projected Annual New Pentagon and Shanksville Responder
Enrollments Under Expanded Eligibility Criteria, FY2024-2028
------------------------------------------------------------------------
Projected new Cumulative new
FY enrollment 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$]
----------------------------------------------------------------------------------------------------------------
Total projected number
of Pentagon/Shanksville Projected total Projected total Total projected
FY responders, current medical costs pharmacy costs costs
eligibility criteria
----------------------------------------------------------------------------------------------------------------
2024.......................... 1,391 $3,061,444 $1,722,479 $4,783,923
2025.......................... 1,513 3,547,280 1,966,896 5,514,176
2026.......................... 1,636 4,033,115 2,211,313 6,244,428
2027.......................... 1,758 4,518,950 2,455,731 6,974,681
2028.......................... 1,880 5,004,785 2,700,148 7,704,933
---------------------------------------------------------------------------------
Total..................... ....................... 20,165,574 11,056,567 31,222,141
----------------------------------------------------------------------------------------------------------------
Next, the projected medical costs and projected pharmacy costs were
divided by the projected number of Pentagon and Shanksville responder
members under the current eligibility criteria (table 2) to calculate
the estimated average per member medical costs and pharmacy costs for
each projected year from FY2024 through FY2028. The total cost per
member was then calculated by summing the per member medical and
pharmacy costs for each fiscal year. See table 3.
Table 3--Projected Medical and Pharmacy Costs per Current Pentagon and Shanksville Responder Member, FY2024-2028
[2024$]
----------------------------------------------------------------------------------------------------------------
Projected Projected Total
FY medical costs pharmacy costs projected cost
per member per member per member
----------------------------------------------------------------------------------------------------------------
2024............................................................ $2,201 $1,238 $3,439
[[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 $5,540,570 (undiscounted) over 5 years.
See table 4.
Table 4--Projected Medical and Pharmacy Costs, New Pentagon and Shanksville Responders Under Expanded
Eligibility Criteria, FY2024-2028
[2024$]
----------------------------------------------------------------------------------------------------------------
Projected Projected
FY cumulative new Projected medical pharmacy cost for Projected total
enrollment costs for cohort cohort 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.
---------------------------------------------------------------------------
\15\ 42 U.S.C. 300mm-41(c)(3) requires WTC Health Program
members to maintain minimum essential insurance coverage.
---------------------------------------------------------------------------
Benefits
The Administrator of the WTC Health Program does not have
information on the health of the population that may
[[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.
---------------------------------------------------------------------------
\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 [email protected].
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.
[[Page 73600]]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average Average burden
Section Title Number of responses per per response Total burden
respondents respondent (hr) (hr)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 88.4.................................... World Trade Center Health Program 500 1 0.5 250
Pentagon/Shanksville Responder
Application for Enrollment.
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
0
1. The authority citation for part 88 is revised to read as follows:
Authority: 42 U.S.C. 300mm to 300mm-64.
0
2. Amend Sec. 88.1 by:
0
a. Revising the definition for ``Act'';
0
b. Adding the definitions for ``Federal agency'' and ``Uniformed
services'' in alphabetical order; and
0
c. Revising the definition for ``WTC Health Program''.
The revisions and additions read as follows:
Sec. 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.
* * * * *
0
3. Amend Sec. 88.4, by revising paragraphs (b) and (c) to read as
follows:
Sec. 88.4 Eligibility criteria--WTC responders.
* * * * *
(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.
[[Page 73601]]
(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.
* * * * *
0
4. Amend Sec. 88.6, by revising paragraph (c)(2) to read as follows:
Sec. 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 Sec. Sec. 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 Sec. Sec. 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.
* * * * *
0
5. Amend Sec. 88.12, by revising paragraphs (b) introductory text and
(b)(3) to read as follows:
Sec. 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
Sec. Sec. 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 Sec. 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]
BILLING CODE 4165-18-P