World Trade Center Health Program; Addition of New-Onset Chronic Obstructive Pulmonary Disease and WTC-Related Acute Traumatic Injury to the List of WTC-Related Health Conditions, 43510-43523 [2016-15799]
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Dated: June 27, 2016.
Joel Beauvais,
Deputy Assistant Administrator, Office of
Water.
[FR Doc. 2016–15844 Filed 7–1–16; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 88
[Docket No. CDC–2015–0063, NIOSH–287]
RIN 0920–AA61
World Trade Center Health Program;
Addition of New-Onset Chronic
Obstructive Pulmonary Disease and
WTC-Related Acute Traumatic Injury to
the List of WTC-Related Health
Conditions
Centers for Disease Control and
Prevention, HHS.
ACTION: Final rule.
AGENCY:
The World Trade Center
(WTC) Health Program conducted a
review of published, peer-reviewed
epidemiologic studies regarding
potential evidence of chronic
obstructive pulmonary disease (COPD)
and acute traumatic injury among
individuals who were responders to or
survivors of the September 11, 2001,
terrorist attacks. The Administrator of
the WTC Health Program
(Administrator) found that these studies
provide substantial evidence to support
a causal association between each of
these health conditions and 9/11
exposures. As a result, the
Administrator is publishing a final rule
to add both new-onset COPD and WTCrelated acute traumatic injury to the List
of WTC-Related Health Conditions
eligible for treatment coverage in the
WTC Health Program.
DATES: This rule is effective on August
4, 2016.
FOR FURTHER INFORMATION CONTACT:
Rachel Weiss, Program Analyst, 1090
Tusculum Ave, MS: C–46, Cincinnati,
OH 45226; telephone (855)818–1629
(this is a toll-free number); email
NIOSHregs@cdc.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Table of Contents
I. Executive Summary
A. Purpose of Regulatory Action
B. Summary of Major Provisions
C. Costs and Benefits
II. Public Participation
III. Background
A. WTC Health Program Statutory
Authority
B. Evidence Supporting the Addition of
New-Onset COPD and WTC-Related
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Acute Traumatic Injury to the List of
WTC-Related Health Conditions
IV. Effects of Rulemaking on Federal
Agencies
V. Summary of Peer Reviews and Public
Comments—New-Onset COPD
A. Peer Review
B. Public Comment
VI. Summary of Peer Reviews and Public
Comments—WTC-Related Acute
Traumatic Injury
A. Peer Review
B. Public Comment
VII. How To Get Help for WTC-Related
Health Conditions
VIII. Summary of Final Rule
IX. Regulatory Assessment Requirements
A. Executive Order 12866 and Executive
Order 13563
B. Regulatory Flexibility Act
C. Paperwork Reduction Act
D. Small Business Regulatory Enforcement
Fairness Act
E. Unfunded Mandates Reform Act of 1995
F. Executive Order 12988 (Civil Justice)
G. Executive Order 13132 (Federalism)
H. Executive Order 13045 (Protection of
Children From Environmental Health
Risks and Safety Risks)
I. Executive Order 13211 (Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use)
J. Plain Writing Act of 2010
I. Executive Summary
A. Purpose of Regulatory Action
This rulemaking is being conducted
in order to add new-onset COPD and
WTC-related acute traumatic injury 1 to
the List of WTC-Related Health
Conditions (List). Following the receipt
of letters from the directors of the WTC
Health Program Clinical Centers of
Excellence (CCEs) and Data Centers to
the WTC Health Program supporting
coverage of all cases of COPD (including
new-onset COPD) and significant
traumatic injuries within the Program,2
the Administrator decided to conduct
literature reviews regarding COPD and
acute traumatic injuries among 9/11
1 The term ‘‘WTC-related’’ was not included in
the proposed definition of acute traumatic injury in
the notice of proposed rulemaking, 80 FR 54746
(Sept. 11, 2015), but has been added in the final
rule to clarify specific usage in the WTC Health
Program and better parallel ‘‘WTC-related
musculoskeletal disorder’’ on the List. The
Administrator finds that revising the term results in
no substantive change from the proposed rule. See
discussion infra Section VIII.
2 Michael Crane, Roberto Lucchini, Jacqueline
Moline, et al., Letter from CCE and Data Center
Directors to Dori Reissman and John Halpin, WTC
Health Program Regarding ‘‘Musculoskeletal
Conditions,’’ May 11, 2014; and Michael Crane,
Roberto Lucchini, Jacqueline Moline, et al., Letter
from CCE and Data Center Directors to Dori
Reissman and John Halpin, WTC Health Program
Regarding ‘‘Rationale for the Continued
Certification of COPD as a World Trade Center
Related and Covered Condition,’’ Apr. 22, 2014.
These letters are included in the docket for this
rulemaking.
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responders and survivors. Based on the
findings of those reviews, he
determined that the evidence for causal
associations between 9/11 exposures
and new-onset COPD and acute
traumatic injury, respectively, provides
sufficient bases for the addition of both
health conditions to the List. The
Administrator published a proposed
rule to add new-onset COPD and acute
traumatic injury to the List on
September 11, 2015,3 and finalizes the
rule in this action.
B. Summary of Major Provisions
This final rule adds new-onset COPD
and WTC-related acute traumatic injury
to the List of WTC-Related Health
Conditions in 42 CFR 88.1. As of the
effective date of this rule, these
conditions will be eligible for treatment
by the WTC Health Program.
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C. Costs and Benefits
The addition of new-onset COPD and
WTC-related acute traumatic injury to
the List of WTC-Related Health
Conditions through this rulemaking is
estimated to cost the WTC Health
Program from $4,602,162 to $5,666,713
annually, between 2016 and 2019. All of
the costs to the WTC Health Program are
transfers. Benefits to current and future
WTC Health Program members may
include improved access to care and
better treatment outcomes than in the
absence of Program coverage.
II. Public Participation
On September 11, 2015, the
Administrator published a notice of
proposed rulemaking (NPRM) to
propose the addition of new-onset
COPD and acute traumatic injury to the
List in 42 CFR 88.1.4 The Administrator
asked peer reviewers to evaluate the
scientific literature review and
Administrator’s determination and
invited interested members of the public
or organizations to participate in the
rulemaking by submitting written views,
opinions, recommendations, and/or
data. This final rule describes feedback
received from both peer reviewers and
public commenters.
A total of six peer reviewers were
charged with reviewing the
Administrator’s evaluation of the
evidence for adding the two conditions
to the List. Three pulmonary disease
experts reviewed the evidence for the
addition of new-onset COPD and three
injury experts reviewed the evidence for
the addition of acute traumatic injury.
Specifically, the peer reviewers were
asked to answer the following questions:
3 80
FR 54746.
4 Id.
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1. Are you aware of any other studies
which should be considered? If so,
please identify them.
2. Have the requirements of the Policy
and Procedures for Adding Non-Cancer
Conditions to the List of WTC-Related
Health Conditions 5 appropriately been
fulfilled? If not, please explain which
elements are missing or deficient.
3. Is the interpretation of the available
data appropriate, and does it support
the conclusion? If not, please explain
why.
Public comments were invited on any
topic related to the proposed rule, and
specifically on the following questions:
1. Is September 11, 2003 an
appropriate deadline by which an
individual must have received initial
medical treatment for an acute traumatic
injury?
2. Is there evidence of acute traumatic
injuries that occurred as a result of the
September 11, 2001, terrorist attacks
that would not be covered by the
proposed definition? What are the types
of long-term consequences or medically
associated health conditions that result
from the treatment or progression of
acute traumatic injuries like those
sustained on or after September 11,
2001?
3. Are data available on the chronic
care needs of individuals who suffered
acute traumatic injuries during the
September 11, 2001, terrorist attacks,
and its aftermath that the Administrator
can use to estimate the number of
current and future WTC Health Program
members who may seek certification of
WTC-related acute traumatic injury as
well as treatment costs?
4. Are data available on the
prevalence and cost estimates for newonset COPD?
The Administrator received 16
submissions to the rulemaking docket
from the public, including the following
individuals and organizations: 10
unaffiliated commenters; one individual
who is a responder or survivor; two selfidentified responders; sister non-profit
organizations dedicated to preventing
and curing alpha-1 antitrypsin
deficiency and COPD; a labor union;
and the WTC Health Program Survivors
and Responders Steering Committees.
The peer reviews and public
comments are found in the docket for
this rulemaking. Summaries of all peer
reviews and public comments, as well
as the Administrator’s responses, are
found below.
Howard, Administrator of the WTC Health
Program, Policy and Procedures for Adding NonCancer Conditions to the List of WTC-Related
Health Conditions, revised Oct. 21, 2014, https://
www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_
NonCancers_21_Oct_2014.pdf.
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43511
III. Background
A. WTC Health Program Statutory
Authority
Title I of the James Zadroga 9/11
Health and Compensation Act of 2010
(Zadroga Act), Public Law 111–347, as
amended by Public Law 114–113, added
Title XXXIII to the Public Health
Service Act (PHS Act),6 establishing the
WTC Health Program within the
Department of Health and Human
Services (HHS). The WTC Health
Program provides medical monitoring
and treatment benefits to eligible
firefighters and related personnel, law
enforcement officers, and rescue,
recovery, and cleanup workers who
responded to the September 11, 2001,
terrorist attacks in New York City, at the
Pentagon, and in Shanksville,
Pennsylvania (responders), and to
eligible persons who were present in the
dust or dust cloud on September 11,
2001 or who worked, resided, or
attended school, childcare, or adult
daycare in the New York City disaster
area (survivors).
All references to the Administrator of
the WTC Health Program
(Administrator) in this document mean
the Director of the National Institute for
Occupational Safety and Health
(NIOSH) or his or her designee. Section
3312(a)(6) of the PHS Act requires the
Administrator to conduct rulemaking to
propose the addition of a health
condition to the List codified in 42 CFR
88.1.
B. Evidence Supporting the Addition of
New-Onset COPD and WTC-Related
Acute Traumatic Injury to the List of
WTC-Related Health Conditions
Consideration of an addition to the
List may be initiated at the
Administrator’s discretion 7 or following
receipt of a petition by an interested
party.8 Under 42 CFR 88.17, the
Administrator has established a process
by which health conditions may be
considered for addition to the List of
WTC-Related Health Conditions in
§ 88.1. Pursuant to section 3312(a)(6)(D)
of the PHS Act, whenever the
Administrator determines that a
condition should be proposed for
addition to the List, he is required to
publish an NPRM and allow interested
parties to comment on the proposed
rule.
6 Title XXXIII of the PHS Act is codified at 42
U.S.C. 300mm to 300mm–61. Those portions of the
Zadroga Act found in Titles II and III of Pub. L.
111–347 do not pertain to the WTC Health Program
and are codified elsewhere.
7 PHS Act, sec. 3312(a)(6)(A); 42 CFR 88.17(b).
8 PHS Act, sec. 3312(a)(6)(B); 42 CFR 88.17(a).
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The Administrator also follows the
WTC Health Program’s policy and
procedures for evaluating whether to
add non-cancer health conditions to the
List of WTC-Related Health Conditions,
published online in the Policies and
Procedures section of the WTC Health
Program Web site.9 The Administrator
amended the policy since it was used to
conduct the analysis of COPD and acute
traumatic injury studies for the NPRM;10
changes to the policy are not substantive
and are intended to clarify terminology
and specific procedures. The policy’s
descriptions of what studies will be
evaluated in the literature evidence
review and analyzed in the scientific
and medical assessment have been
revised to clarify the types of studies
considered peer-reviewed, published,
epidemiologic studies.11 The
Administrator has also revised an
existing footnote regarding distinct
criteria for assessing certain conditions
with immediate and observable cause
and effect.12 These criteria were already
included in the assessment conducted
for the analysis of acute traumatic injury
studies published in the NPRM.13 In
accordance with the policy, the
Administrator directed the WTC Health
Program Associate Director for Science
(ADS) to conduct a review of the
scientific literature to determine if the
available scientific information on
COPD and acute traumatic injury,
respectively, had the potential to
9 John Howard, Administrator of the WTC Health
Program, Policy and Procedures for Adding NonCancer Conditions to the List of WTC-Related
Health Conditions, revised May 11, 2016, https://
www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_
NonCancer_Conditions_Revision_11_May_
2016.pdf.
10 An October 2014 version of the policy was used
to conduct the review in the September 2015
NPRM. See John Howard, Administrator of the
WTC Health Program, Policy and Procedures for
Adding Non-Cancer Conditions to the List of WTCRelated Health Conditions, revised Oct. 21, 2014,
https://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_
NonCancers_21_Oct_2014.pdf.
11 The clarification of the description of the
studies was made in response to peer review
comments on the WTC-related acute traumatic
injury analysis. See discussion of these comments
infra Section VI.A.
12 The footnote to the policy explains that injury
studies are assessed for relevance, quantity, quality,
known causation, and onsite occurrence and that
information in the studies about injuries recorded
in contemporaneous medical records and studies,
combined with known hazards and known
connections between those hazards and injury, may
be useful to the Administrator’s evaluation of any
support for a causal association between those
exposures and the injury. See footnote 12, John
Howard, Administrator of the WTC Health Program,
Policy and Procedures for Adding Non-Cancer
Conditions to the List of WTC-Related Health
Conditions, revised May 11, 2016, https://
www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_
NonCancer_Conditions_Revision_11_May_
2016.pdf.
13 80 FR 54746, 54754.
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provide a basis for a decision on
whether to add the conditions to the
List. The literature review included
published, peer-reviewed epidemiologic
studies, including direct observational
studies,14 about each health condition
among 9/11-exposed populations. The
studies were reviewed for their
relevance, quantity, and quality to
determine whether they had the
potential to provide a sufficient basis for
the Administrator’s decision to propose
adding each health condition to the List.
After finding that the available
evidence had the potential to provide
bases for the decisions, the ADS further
assessed the scientific and medical
evidence to determine whether causal
associations between 9/11 exposures
and new-onset COPD and acute
traumatic injury, respectively, were
supported. A health condition may be
added to the List if published, peerreviewed epidemiologic studies provide
substantial support 15 for a causal
association between 9/11 exposures and
the health condition in 9/11-exposed
populations.
In this case, the Administrator finds
there is substantial evidence in
published, peer-reviewed epidemiologic
studies that 9/11 exposures produced
chronic airway inflammation
manifested by persistent lower
respiratory symptomatology and decline
in pulmonary function, which
progressed to new-onset COPD in a
proportion of exposed subjects in the
period since exposure, independently
from any cigarette smoking among the
cohort. This evidence provides
substantial support for a causal
association between 9/11 exposures and
new-onset COPD.
The Administrator also finds that
evidence in the published, peerreviewed epidemiologic studies
evaluated by the ADS provides
substantial support for a causal
association between 9/11 exposures and
acute traumatic injuries among
responders and survivors to the
September 11, 2001, terrorist attacks.
The reviews of evidence and
Administrator’s determinations
concerning the addition of new-onset
COPD 16 and WTC-related acute
traumatic injury 17 are found, in full, in
the NPRM.
14 See discussion of these terms infra Section
IV.A.
15 The substantial evidence standard is met when
the Program assesses all of the available, relevant
information and determines with high confidence
that the evidence supports its findings regarding a
causal association between the 9/11 exposure(s) and
the health condition.
16 See 80 FR 54746 at 54748.
17 Id. at 54752–54754.
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IV. Effects of Rulemaking on Federal
Agencies
Title II of the Zadroga Act reactivated
the September 11th Victim
Compensation Fund (VCF).
Administered by the U.S. Department of
Justice (DOJ), the VCF provides
compensation to any individual or
representative of a deceased individual
who was physically injured or killed as
a result of the September 11, 2001,
terrorist attacks or during the debris
removal. Eligibility criteria for
compensation by the VCF include a list
of presumptively covered health
conditions, which are physical injuries
determined to be WTC-related health
conditions by the WTC Health Program.
Pursuant to DOJ regulations, the VCF
Special Master is required to update the
list of presumptively covered conditions
when the List of WTC-Related Health
Conditions in 42 CFR 88.1 is updated.18
V. Summary of Peer Reviews and
Public Comments—New-Onset COPD
As discussed above in the Public
Participation section, the Administrator
solicited reviews of the NPRM by three
experts in the field of pulmonary
disease who provided peer review of the
evidence supporting the addition of
new-onset COPD. In addition to the peer
reviews, the Administrator received
submissions from public commenters.
The COPD-related peer reviews and
public comments are summarized
below, and each is followed by a
response from the Administrator.
A. Peer Review
First, peer reviewers were asked
whether they were aware of any other
studies which should have been
considered in the NPRM, with regard to
new-onset COPD. Second, the peer
reviewers were asked whether the
requirements of the Policy and
Procedures for Adding Non-Cancer
Conditions to the List of WTC-Related
Health Conditions, described above, had
been fulfilled. Third, the peer reviewers
were asked whether the Administrator’s
interpretation of the evidence for newonset COPD was appropriate and
whether it supported the decision to
propose adding new-onset COPD to the
List.
Identification of Other Studies To
Support the Administrator’s
Determination
One new-onset COPD peer reviewer
indicated that no additional articles
concerning 9/11 exposures and newonset COPD were identified. Two
reviewers suggested additional studies
18 28
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that the Administrator should have
considered.
One reviewer suggested three
additional studies for the
Administrator’s consideration, two of
which referenced 9/11 exposures among
WTC responders with lower respiratory
symptoms. The first study, Mauer et
al.,19 did not include spirometry, and
the second study, Niles et al.,20 did not
specifically address the occurrence of
COPD among the 9/11-exposed
population but examined the extent to
which early post-disaster symptoms and
diagnoses accurately anticipate future
healthcare needs. The third study,
Lange et al.,21 was not an epidemiologic
study of 9/11-exposed populations, and
thus was not further considered. As
stated in the NPRM preamble, only
epidemiologic studies that reported
compatible new-onset, ‘‘post-9/11 lower
respiratory symptomatology and
objective measurements of airways
obstruction, such as pre- and post-9/11
spirometry with bronchodilator
administrator or IOS [impulse
oscillometry] were found to exhibit
potential support’’ 22 for a
recommendation to add the health
condition to the List and selected for
further quality review. Since the Mauer
and Niles studies did not meet this
standard, they were not further
reviewed.
The other reviewer suggested a review
of the literature on non-smoking
inhalational exposures, which are
responsible for 15 percent of COPD
cases, and noted that COPD can present
years after relevant exposures. The
Administrator agrees that COPD
attributed to occupational and
environmental exposures may present
several years after cessation of
exposures; however, the matter of
maximum time intervals for the
diagnosis of new-onset COPD is outside
the scope of this rulemaking and will be
addressed through Program policy and
procedures.
One general comment recommended
that the full search string be included in
future assessments so that reviewers can
replicate the literature search. The
Administrator agrees; future
assessments will include full search
19 Matthew Mauer, Karen Cummings, Rebecca
Hoen, Long-Term Respiratory Symptoms in World
Trade Center Responders, Occup Med (Lond)
2010;60(2):145–51.
20 Justin Niles, Mayris Webber, Hillel Cohen, et
al., The Respiratory Pyramid: From Symptoms to
Disease in World Trade Center Exposed Firefighters,
Am J Ind Med 2013;56(8):870–80.
21 Peter Lange, Bartolome Celli, Alvar Agustı, et
´
al., Lung-Function Trajectories Leading to Chronic
Obstructive Pulmonary Disease, N Engl J Med
2015;373:111–122.
22 80 FR 54746 at 54749.
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strings so that reviewers may replicate
the ADS’s literature review.23
Administrator’s Compliance With
Established Policy and Procedures To
Add Non-Cancer Health Conditions to
the List of WTC-Related Health
Conditions
All three of the new-onset COPD peer
reviewers agreed that the requirements
of the policy had been fulfilled.
Administrator’s Interpretation of
Evidence for the Addition of New-Onset
COPD
All three new-onset COPD reviewers
found that the interpretation of the
available literature was appropriate and
supported the Administrator’s
conclusion. One reviewer identified
challenges with establishing an
operational definition of COPD and how
the definition would be applied to WTC
Health Program members. The reviewer
asked whether an individual with
potentially relevant symptoms (such as
lower respiratory symptoms or
symptoms of chronic bronchitis) and
normal spirometry has COPD. The
commenter noted that ‘‘obstructive
chronic bronchitis,’’ included in the
description of COPD in the NPRM
preamble, does not appear in the Global
Initiative for Chronic Obstructive Lung
Disease (GOLD) recommendations, and
its inclusion in the NPRM preamble
implies that the WTC Health Program
member would not be considered to
have COPD if diagnosed with chronic
bronchitis in the absence of
demonstrated airflow obstruction. The
reviewer also asked whether impulse
oscillometry alone can support a COPD
diagnosis, and pointed out that GOLD
does not include impulse oscillometry
as a diagnostic test for COPD. Finally,
the reviewer asked whether the WTC
Health Program will require
identification of emphysema, included
under the COPD category, by
computerized tomography (CT) scan
imaging even in the absence of
demonstrated spirometric airflow
obstruction.
The reviewer accurately notes the
difficulties in choosing a single
definition of COPD for the purpose of
this rulemaking. As discussed in the
NPRM, COPD is an umbrella term and
encompasses a variety of pulmonary
conditions; various definitions exist,
23 In the case of COPD, the full search string
consisted of the following: (‘‘chronic obstructive
pulmonary disease’’ OR ‘‘chronic bronchitis’’ OR
‘‘pulmonary emphysema’’ OR ‘‘pulmonary function
decline’’ OR ‘‘respiratory insufficiency’’ OR
‘‘airways obstruction’’ OR ‘‘airflow limitation’’)
AND (‘‘September 11 Terrorist Attacks’’ OR ‘‘World
Trade Center’’ OR WTC OR ‘‘September 11’’ OR 9/
11).
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43513
making the interpretation of evidence
for adding new-onset COPD to the List
a challenge. The GOLD definition of
COPD, which requires spirometric
evidence of airflow limitation, was used
to provide an objective parameter to
evaluate the occurrence of COPD among
the 9/11-exposed populations identified
in the surveillance literature reviewed
by the ADS. Chronic obstructive
bronchitis is a subtype of chronic
bronchitis associated with airflow
limitation, as recognized by the National
Heart, Lung, and Blood Institute.24
Relying on the Merck Manual, the
NPRM preamble utilized a definition of
‘‘obstructive chronic bronchitis’’ that
emphasizes the need for spirometric
evidence of airflow obstruction.
Diagnosis of COPD requires
confirmation, using spirometry, of
airflow limitation that is not fully
reversible, as well as a history of
potentially causative exposure among
symptomatic individuals. In some
circumstances, in addition to
spirometry, impulse oscillometry may
be presented to support the COPD
diagnosis by detecting subtle changes in
a patient’s airways function earlier than
with conventional spirometry.25
The WTC Health Program will
provide specific instruction to
physicians regarding diagnostic
standards for new-onset COPD.
Certification of cases of new-onset
COPD in individual WTC Health
Program members will be decided by
the Program on a case-by-case basis, in
accordance with section 3312(b)(2)(B) of
the PHS Act and 42 CFR 88.13.
B. Public Comment
Support for New-Onset COPD
Many commenters expressed support
for the addition of new-onset COPD to
the List. One commenter found that the
Administrator presented quality
evidence that establishes a causal
association between 9/11 exposures and
new-onset COPD. Although some
submissions only addressed the
addition of acute traumatic injury, no
commenters opposed the addition of
new-onset COPD.
Additional Studies To Support the
Addition of New-Onset COPD to the List
One commenter suggested the
consideration of a 2010 study by
24 See NIH, National Heart, Lung, and Blood
Institute, Executive Summary, https://
www.nhlbi.nih.gov/research/reports/2011bronchitis.
25 Christopher Cooper, Assessment of Pulmonary
Function in COPD, Semin Respir Crit Care Med
2005;26(2):246–52.
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Banauch et al.26 to support the addition
of COPD to the List. Another commenter
offered a list of additional articles that
should have been reviewed.
The Banauch study was reviewed and
found to be relevant; however, it was
not selected to undergo further evidence
review due to its small number of study
participants (n = 90). The papers cited
by the second commenter were
reviewed during the literature review
process; however, only epidemiologic
studies that reported compatible post-9/
11 lower respiratory symptomatology
and objective measurements of airways
obstruction, such as pre- and post-9/11
spirometry with bronchodilator
administration or impulse oscillometry
were found to exhibit potential for a
recommendation and selected for
review. Two of the references offered by
the commenter, Aldrich et al. and
Weakley et al., were included in the
ADS’s review published in the NPRM.
addition of acute traumatic injury. In
addition to the peer reviews, the
Administrator received submissions
from public commenters. All of the
acute traumatic injury-related peer
reviews and public comments are
summarized below, and each is
followed by a response from the
Administrator.
VI. Summary of Peer Reviews and
Public Comments—WTC-Related Acute
Traumatic Injury
A. Peer Review
First, with regard to acute traumatic
injury, peer reviewers were asked
whether they were aware of any other
studies which should have been
considered in the NPRM. Second, the
peer reviewers were asked whether the
requirements of the Policy and
Procedures for Adding Non-Cancer
Conditions to the List of WTC-Related
Health Conditions, described above, had
been fulfilled. Third, the peer reviewers
were asked whether the Administrator’s
interpretation of the evidence for the
addition of acute traumatic injury was
appropriate and whether it supported
the decision to propose adding acute
traumatic injury to the List.
As discussed above in the Public
Participation section, the Administrator
solicited reviews of the NPRM by three
injury experts who provided peer
review of the evidence supporting the
Identification of Other Studies To
Support the Administrator’s
Determination
All three acute traumatic injury peer
reviewers indicated that they were
unaware of any additional studies
concerning acute traumatic injury that
should have been considered by the
Administrator. One reviewer suggested
that a complete list of citations that
were excluded from the ADS’s review as
not relevant should have been provided
to reviewers. The Administrator agrees
to make the full list of citations
identified in the literature review as
well as excluded scientific papers
available to reviewers in future rulerelated peer reviews.27
Administrator’s Compliance With
Established Policy and Procedures To
Add Non-Cancer Health Conditions to
the List of WTC-Related Health
Conditions
Two of the acute traumatic injury peer
reviewers found that the requirements
of the policy had been fulfilled. One
reviewer asked about the intent of
describing the studies discussed in the
assessment as ‘‘direct observational
studies rather than epidemiologic
studies,’’ further asking whether it
meant that causation is in question or
that rates could not be computed.
Database
Search terms
PubMed .....................................................
(‘‘September 11 Terrorist Attacks’’ [Mesh] OR ‘‘World Trade Center’’ [TIAB] OR
WTC [TIAB] OR ‘‘September 11’’ [TIAB]) AND (‘‘Wounds and Injuries’’ [Mesh]
OR ‘‘Occupational Injuries’’ [Mesh] OR ‘‘Cumultative Trauma Disorders’’ [Mesh]
OR Injuries [TIAB]) From 2001/09/01 to 2014/12/31.
(‘‘MH Wounds and Injuries+’’) AND (‘‘World Trade Center’’ OR ‘‘September 11’’) ....
(‘‘World Trade Center’’ OR ‘‘September 11’’) AND (Injury or injuries) ........................
World Trade Center.mp. OR September 11.mp. AND exp injury/ (english language
and embase and yr = ‘‘2001–Current’’).
(‘‘World Trade Center’’ OR ‘‘September 11’’) AND (injuries OR injury) ......................
World Trade Center (Title) AND Injury or Injuries (All Fields) .....................................
CINAHL .....................................................
Web of Science ........................................
EMBASE ...................................................
Health & Safety Science Abstracts ...........
NIOSHTIC-2 ..............................................
Results
114
36
147
191
31
22
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The October 2014 version of the WTC
Health Program’s policy and procedures
on adding non-cancers to the List used
to evaluate acute traumatic injury
studies for the NPRM distinguished
between those types of epidemiologic
studies that can be used to identify
causal associations between exposures
and health outcomes such as diseases,
and those studies that can be used to
identify causal associations between
exposures and health outcomes such as
cases of injury.28 The terminology
‘‘direct observational studies’’ was an
attempt to use plain language to
describe the types of studies that could
provide relevant evidence of a causal
association between 9/11 exposures and
a health outcome, such as an injury.
However, rather than making the intent
clear, it appears that the term may be
confusing. By describing the studies
used to identify certain health outcomes
as ‘‘direct observational studies,’’ the
WTC Health Program intended to
describe studies which are more often
referred to as ‘‘descriptive
epidemiologic studies’’ within the
scientific community. As discussed
above, recent amendments to the policy
clarify the terminology to mitigate
confusion regarding the types of
information sources the WTC Health
Program uses to support the addition of
certain health conditions to the List.29
26 Gisela Banauch, Mark Brantley, Gabriel Izbicki,
et al., Accelerated Spirometric Decline in New York
City Firefighters with a1 –Antitrypsin Deficiency,
CHEST 2010;138(5):1116–1124.
27 The table below provides the search strings
used to conduct the literature search; the full list
of citations identified by the literature search
conducted by the ADS is not provided here. The
NPRM incorrectly identified search terms used in
the literature review (80 FR 54746 at 54752); the
terms identified in the NPRM were instead terms
used to develop cost estimates for the Executive
Order 12866 and Executive Order 13563 analysis in
Section VIII.A.
28 See John Howard, Administrator of the WTC
Health Program, Policy and Procedures for Adding
Non-Cancer Conditions to the List of WTC-Related
Health Conditions, revised Oct. 21, 2014, https://
www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_
NonCancers_21_Oct_2014.pdf.
29 John Howard, Administrator of the WTC Health
Program, Policy and Procedures for Adding NonCancer Conditions to the List of WTC-Related
Health Conditions, revised May 11, 2016, https://
www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_
NonCancer_Conditions_Revision_11_May_
2016.pdf.
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In accordance with both the previous
and current policy and procedures on
adding non-cancers to the List used to
develop this rulemaking, the ADS
searched published, peer-reviewed
epidemiologic studies of acute traumatic
injuries in the 9/11-exposed population,
including studies referred to in the
October 2014 policy as ‘‘direct
observational studies.’’ The
epidemiologic studies reviewed for this
rulemaking to support the addition of
WTC-related acute traumatic injury to
the List document that outcomes
occurred because of the 9/11 exposures
and, thus, can be used to establish a
causal association between the 9/11related event, such as being struck by
falling debris, and the injury, such as a
broken arm. The studies reviewed allow
the Administrator to conclude that
certain types of acute traumatic injury
suffered by WTC responders and
survivors were sustained during or in
the aftermath of the September 11, 2001,
terrorist attacks and find that the
evidence provides substantial support
for a causal association between acute
traumatic injury and 9/11 exposures.
The reviewer also found it difficult to
assess adherence to the policy because
of a perceived lack of clarity with regard
to the scope of the Administrator’s
inquiry and suggested that injuries
should be identified as ‘‘acute,’’
‘‘subacute,’’ and ‘‘chronic.’’ The
reviewer further questioned the
distinction between a broad
understanding of injuries which are
musculoskeletal in nature and the
Administrator’s definition of ‘‘acute
traumatic injury’’ and suggested the
removal of a statement found in the
NPRM characterizing musculoskeletal
disorders as distinct from acute
traumatic injuries, pointing out that
many of the types of acute traumatic
injury identified by the Administrator
are musculoskeletal in nature. The
reviewer suggested that the
Administrator should have better
clarified the distinction between acute
and chronic traumatic injury (injuries
caused by multiple exposures over time)
and recommends that such a discussion
be added to the analysis in the NPRM.
Without this more robust discussion,
the reviewer questioned how the
definition of acute traumatic injury will
be applied, particularly with regard to
the timing of initial medical care postinjury, diagnosis of head trauma,
treatment of chronic pain, medically
associated health conditions, and preexisting injuries.
The term ‘‘WTC-related
musculoskeletal disorder’’ is defined in
the PHS Act and statements in the
NPRM regarding ‘‘musculoskeletal
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disorders’’ are based on, and are
consistent with, the statutory definition
which sets out a clear standard for
identifying chronic or recurrent
disorders of the musculoskeletal system,
caused by heavy lifting or repetitive
strain.30 In contrast to the term ‘‘chronic
traumatic injury,’’ used by the reviewer,
the Administrator defines a ‘‘WTCrelated acute traumatic injury’’ as an
injury that occurred suddenly during
one incident involving exposure to an
external event. The new definition of
‘‘WTC-related acute traumatic injury’’
may capture musculoskeletal injuries
which do not meet the statutory
definition of ‘‘WTC-related
musculoskeletal disorder.’’ The purpose
of this action is to provide Program
coverage for those injuries that do not
meet the existing definition of WTCrelated musculoskeletal disorder, such
as, for example, those not caused by
heavy lifting or repetitive strain.
The reviewer’s detailed questions
regarding how the definition of WTCrelated acute traumatic injury will be
operationalized will be answered in
forthcoming guidance to CCE and NPN
physicians. Each WTC Health Program
member’s health condition will be
evaluated in accordance with the
Program’s published policies and
procedures.
Administrator’s Interpretation of
Evidence for the Addition of Acute
Traumatic Injuries
Two of the acute traumatic injury peer
reviewers found the Administrator’s
interpretation of the available data to be
appropriate.
One reviewer found the presentation
of data to be confusing and the
Administrator’s final determination
concerning the addition of acute
traumatic injury to the List unclear with
regard to its scope. The reviewer
acknowledged that the ADS may have
encountered difficulties obtaining
evidence of injury severity and
outcomes, which the reviewer felt were
crucial to a true understanding of the
chronicity or level of injury severity,
and disagreed with the Administrator’s
conclusion regarding the types of acute
30 Pursuant to sec. 3312(a)(4) of the PHS Act,
‘‘WTC-related musculoskeletal disorder’’ means a
chronic or recurrent disorder of the musculoskeletal
system caused by heavy lifting or repetitive strain
on the joints or musculoskeletal system occurring
during rescue or recovery efforts in the New York
City disaster area in the aftermath of the September
11, 2001, terrorist attacks. For a WTC responder
who received any treatment for a WTC-related
musculoskeletal disorder on or before September
11, 2003, eligible musculoskeletal disorders
include: (i) Low back pain; (ii) Carpal tunnel
syndrome [CTS]; (iii) Other musculoskeletal
disorders. See also 42 CFR 88.1.
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traumatic injuries identified by the
literature. According to the reviewer,
the documentation of extreme injuries
in the surveillance literature should not
lead to conclusions regarding the types
of injuries and their outcomes. The
reviewer suggested various edits to the
Administrator’s assessment of the data,
published in the NPRM, to either omit
the word ‘‘severe’’ in reference to burns,
or define it in terms of total body
surface area and burn depth, and to
clarify that the severity of injury could
not be ascertained from the studies
reviewed. The reviewer disagreed with
the Administrator’s conclusion that an
eye injury, such as corneal abrasion,
could be caused by an exposure to
energy. Ultimately, the reviewer
disagreed with the Administrator’s
proposed definition of acute traumatic
injury and instead suggested that the
Administrator define trauma as a cause
of injury. Such injuries would include
all types of traumatic events regardless
of the body area or organ system
injured. Examples include, but are not
limited to head injury, burns, ocular
injury, fractures, and tendon and other
soft-tissue injuries.
In his evaluation of the data quality,
the Administrator acknowledged that
some information was not captured by
the studies, and although he agrees that
a full understanding of the severity of
injuries suffered on or after September
11, 2001 may not be gleaned from the
studies reviewed, he found that the data
were sufficient to corroborate the
findings of the CCEs and Data Centers
and to develop a broad definition of
‘‘acute traumatic injury.’’ The use of the
word ‘‘severe’’ to describe burns was
intended to reflect the request made by
the CCE and Data Center directors,
which referred to the types of injuries
they were seeing as ‘‘significant’’ and
‘‘severe.’’ As discussed in the NPRM
preamble, the types of injuries described
by the CCE and Data Center directors are
those that are most likely to result in the
need for the services provided by the
WTC Health Program and thus are those
that the Administrator intended to
capture by adding this health condition
to the List. However, the Administrator
agrees that the word ‘‘severe’’ is not
defined, either in the surveillance
literature or by the Administrator in the
NPRM preamble. The word ‘‘severe,’’ as
used to describe burns in the proposed
definition of ‘‘acute traumatic injury,’’ is
stricken from the final regulatory text in
response to this review.
The Administrator’s intent is to add
coverage of acute traumatic injury
caused by 9/11 exposures. The
reviewer’s proposal incorporates all
types of trauma, including chronic or
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recurrent disorders of the
musculoskeletal system, caused by
heavy lifting or repetitive strain, which
are already covered for responders by
the Program under the PHS Act’s
definition of ‘‘WTC-related
musculoskeletal disorder.’’ The edits
proposed by the reviewer would not
substantively alter the evaluation of the
available literature or the
Administrator’s determination that the
available scientific evidence supports
adding WTC-related acute traumatic
injury to the List.
The Administrator based the
regulatory definition of WTC-related
acute traumatic injury on several
established definitions, including the
definition used by the NIOSH Traumatic
Injury Program which was accepted by
the National Academy of Sciences in
2008.31 The regulatory definition is
intended to address the etiology of the
injury—that is, that it occurred as the
result of a single incident. The incident,
characterized by an ‘‘exposure to
energy,’’ could include the movement of
dust particles across the surface of the
cornea, and result in an eye injury, such
as a corneal abrasion. Because subacute
and chronic conditions describe further
stages after the injury has occurred,
adding these additional categorizations
to the regulatory definition is
unnecessary. The regulatory definition
includes all acute injuries that meet the
definition.
The reviewer also asserted that the
September 11, 2003 treatment cut-off
‘‘seems excessively long for most types
of acute trauma but too short for
others,’’ and is not supported by
evidence. According to the reviewer, the
data presented in the NPRM
demonstrated that most acute traumatic
injuries were treated within hours of
being sustained, although traumatic
brain injuries may not have been
identified for years after the event.
The Administrator agrees that the
evidence reviewed in the NPRM
demonstrates that most acute traumatic
injuries were treated soon after they
were sustained. The end date for initial
treatment is well beyond the response
and recovery period for the three sites
and generously allows for delays in
seeking treatment. The Administrator
acknowledges that most responders and
survivors who sustained acute traumatic
injuries would have received medical
treatment long before September 11,
2003. The reviewer also accurately
points out that numerous cases of
31 Committee to Review the NIOSH Traumatic
Injury Research Program, Institute of Medicine and
National Research Council, Traumatic Injury
Research at NIOSH, 2009, https://www.nap.edu/
catalog/12459/traumatic-injury-research-at-niosh.
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traumatic brain injury (TBI) identified
in the Rutland-Brown paper, included
in the ADS’s review published in the
NPRM,32 were not diagnosed as TBI
within 3 years of the exposure.
However, each of these persons was
admitted to a hospital for injuries/
illnesses related to the September 11,
2001, terrorist attacks and treated for
head injury or major trauma, but was
not diagnosed with TBI at the time they
initially received medical care. The
regulatory text does not require the
member to have been diagnosed with a
TBI on or before September 11, 2003,
only that he or she received medical
attention for an acute traumatic injury
by that date. When operationalizing the
addition of WTC-related acute traumatic
injury, the Program will ensure that this
is clearly explained to the CCEs and the
NPN. The Administrator finds that the
September 11, 2003 deadline is
consistent with the evidence presented
in the NPRM and is neither too long nor
too short for its intended purpose of
offering a reasonable amount of time in
which to expect that an injury sustained
on or after September 11, 2001 was
treated. As discussed in the NPRM
preamble, the decision was made to set
the end-date because this was the date
used to identify traumatic injuries
eligible for treatment in the WTC
Medical Monitoring and Treatment
Program that preceded the WTC Health
Program; moreover, the PHS Act uses
this date as the treatment cut-off date to
identify musculoskeletal disorders
eligible for certification in responders.
Finally, the reviewer found that the
examples of acute traumatic injuries
identified in the NPRM Summary of
Proposed Rule were unnecessary and
confusing, appearing to attribute
‘‘causality to non-causal events.’’ With
regard to the examples of acute
traumatic injury offered in the Summary
of Proposed Rule, the Administrator
agrees; the sentence could be construed
as not differentiating between causes
and outcomes. This language was used
in the Summary of Proposed Rule
section of the NPRM preamble not to
attribute causation, but to illustrate the
types of injuries that the Program would
find ‘‘acute’’ and ‘‘traumatic.’’ This
language is removed from the final rule
and the Administrator will provide
Program guidance to CCE and NPN
physicians on the identification of acute
traumatic injuries that could be
considered WTC-related.
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80 FR 54746 at 54753.
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B. Public Comment
Support for Acute Traumatic Injuries
Nearly all commenters expressed
support for the addition of acute
traumatic injury to the List. Although
some submissions only addressed the
addition of new-onset COPD, no
commenters opposed the addition of
acute traumatic injury.
Acute Traumatic Injury Medical Care
Cut-off Date
One commenter offered support for
the September 11, 2003 cut-off date.
Three commenters expressed concern
about the proposal to require responders
or survivors who seek certification for
an acute traumatic injury to have
received medical care prior to
September 11, 2003. Commenters
suggested that the time period should be
replaced with a simple requirement that
the injury had to have been documented
in medical records, even if the member
did not receive treatment for the acute
traumatic injury. Alternatively,
commenters suggested that the
September 11, 2003 date should be
pushed back to 2004 to accommodate
those responders or survivors who may
not have recognized the extent of their
injuries and, therefore, did not seek
treatment prior to September 11, 2003,
or those who either lost their medical
records or can no longer obtain them
from emergency rooms or private
physicians.
Requiring only that the acute
traumatic injury appear in the WTC
Health Program member’s medical
record, regardless of treatment, would
not accomplish the Administrator’s
intent to ensure, to the extent possible,
that the member’s acute traumatic injury
was sustained during or in the aftermath
of the September 11, 2001, terrorist
attacks. By requiring that members
demonstrate that they received timely
treatment for acute traumatic injuries,
the Administrator will better be able to
establish a medical history linking the
member’s current chronic injury or
medically associated health condition to
an acute traumatic injury that resulted
from that individual’s 9/11 exposure. As
discussed above, the Administrator has
determined that the September 11, 2003
cut-off date for medical treatment is
supported, and has not identified any
evidence to support extending the cutoff date for another year.
Medically Associated Health Conditions
Two submissions addressed the
matter of health conditions medically
associated with WTC-related acute
traumatic injury. One commenter
offered a first-hand account of the
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health conditions he incurred as a result
of the September 11, 2001, terrorist
attacks, suggesting that he still suffers
from medically associated conditions.
The other commenter expressed concern
that health conditions medically
associated with WTC-related health
conditions were not specifically
addressed in the NPRM, particularly
with regard to acute traumatic injury.
Health conditions medically
associated with WTC-related health
conditions were briefly addressed in the
NPRM.33 The Administrator expects
that many Program members who
experienced an acute traumatic injury
may no longer be dealing with the
primary injury, but are in need of
ongoing medical care for chronic
conditions stemming from the original
injury. For example, a WTC responder
may have suffered a head trauma during
response activities which was resolved
years ago, but may still be coping with
the long-term effects of TBI. Once WTCrelated acute traumatic injury is added
to the List, the WTC responder’s TBI
may be eligible for certification as a
condition medically associated with the
WTC-related acute traumatic injury,
head trauma. Health conditions
medically associated with a WTCrelated health condition are determined
by the Program on a case-by-case basis,
in accordance with published Program
regulations and policies and procedures.
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VII. How To Get Help for WTC-Related
Health Conditions
One commenter described suffering
from untreated, chronic health issues
that may stem from work at Ground
Zero. Although this comment was not
directly related to the rulemaking, the
Administrator wants to remind
individuals who may have responded to
or survived the September 11, 2001,
terrorist attacks, that the WTC Health
Program provides medical monitoring
and treatment for WTC-related health
conditions. An individual may apply to
become a WTC Health Program member
by filling out the appropriate
application, available on the Program’s
Web site here: https://www.cdc.gov/wtc/
apply.html (call 1–888–982–4748 to
discuss the application process).
VIII. Summary of Final Rule
For the reasons discussed above and
in the NPRM, the Administrator amends
42 CFR 88.1, ‘‘List of WTC-related
health conditions,’’ paragraph (1)(v), to
add ‘‘new-onset’’ COPD to the existing
‘‘WTC-exacerbated chronic obstructive
pulmonary disease (COPD).’’ This will
permit the WTC Health Program to
33 See
80 FR 54746 at 54756.
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certify cases of COPD determined to
have been caused or contributed to by
9/11 exposures (considered ‘‘newonset’’ cases), in addition to those cases
of COPD which were exacerbated by 9/
11 exposures and which are already
included on the List.
For the reasons discussed above, the
Administrator also adds ‘‘WTC-related
acute traumatic injury’’ to the List for
WTC responders and screening- and
certified-eligible survivors who received
medical treatment for such an injury on
or before September 11, 2003. The term
‘‘WTC-related acute traumatic injury’’ is
defined as a type of injury characterized
by physical damage to a person’s body
that must have been caused by and
occurred immediately after exposure to
hazards or adverse conditions
characterized by a one-time exposure to
energy resulting from the terrorist
attacks or their aftermath. This
requirement is intended to distinguish
these types of injuries from
musculoskeletal disorders, which are
already included on the List of WTCRelated Health Conditions. As required
by statute, WTC-related musculoskeletal
disorders are considered to be caused by
repetitive motion or heavy lifting; the
health condition ‘‘WTC-related acute
traumatic injury’’ requires a
demonstration of causation by a specific
event or incident. Symptoms of acute
traumatic injuries may not immediately
manifest after the specific event or
incident. The Administrator will issue
guidance to CCE and NPN physicians on
the identification of WTC-related acute
traumatic injury. WTC-related acute
traumatic injury includes, but is not
limited to the following: Eye injury;
burn; head trauma; fracture; tendon tear;
complex sprain; and other similar
injuries. The term ‘‘WTC-related’’ was
not included in the term proposed in
the NPRM; however, the Administrator
finds that adding it would result in no
substantive change from the proposed
rule. It would be in keeping with the
existing definition of ‘‘WTC-related
musculoskeletal disorder’’ and would
also signal that this language was
developed specifically for the purposes
of the WTC Health Program. Finally, to
clarify the Administrator’s intent, the
regulatory text is reorganized slightly
from that which was proposed. The
reorganization has no substantive effect.
IX. Regulatory Assessment
Requirements
A. Executive Order 12866 and Executive
Order 13563
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
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43517
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 13563
emphasizes the importance of
quantifying both costs and benefits,
reducing costs, harmonizing rules, and
promoting flexibility.
This rulemaking has been determined
not to be a ‘‘significant regulatory
action’’ under section 3(f) of Executive
Order 12866. This rule adds new-onset
COPD 34 and WTC-related acute
traumatic injury to the List of WTCRelated Health Conditions established
in 42 CFR 88.1. This rulemaking is
estimated to cost the WTC Health
Program from $4,602,162 to $5,666,713
annually, between 2016 and 2019.35 All
of the costs to the WTC Health Program
will be transfers due to the
implementation of provisions of the
Patient Protection and Affordable Care
Act (ACA) (Pub. L. 111–148) on January
1, 2014. This rulemaking has not been
reviewed by the Office of Management
and Budget (OMB). The rule would not
interfere with State, local, and Tribal
governments in the exercise of their
governmental functions.
Population Estimates
As of December 1, 2015, the WTC
Health Program had enrolled 64,384
responders and 9,358 survivors (73,742
total). Of that total population, 56,207
responders and 4,772 survivors (60,979
total) were participants in previous
WTC medical programs and were
‘grandfathered’ into the WTC Health
Program established by Title XXXIII of
the PHS Act.36 From July 1, 2011 to
34 WTC-exacerbated COPD is a statutorily covered
condition pursuant to PHS Act, sec.
3312(a)(3)(A)(v); this NPRM proposes to add newonset COPD occurring after 9/11 exposures.
35 The low cost estimate reflects the 2016
undiscounted new-onset COPD treatment cost
estimate using WTC Health Program data from
Table 5 and the 2016 undiscounted WTC-related
acute traumatic injury treatment cost estimate from
Table 6. The high cost estimate reflects the high
new-onset COPD treatment cost estimate for 2019,
discounted at 3 percent, using data from Leigh et
al. from Table 5 and the WTC-related acute
traumatic injury treatment cost estimate for 2019,
discounted at 3 percent, from Table 6. Future cost
and prevalence estimates are discounted at 3% and
7% in accordance with OMB Circular A–94,
Guidelines and Discount Rates for Benefit-Cost
Analysis of Federal Programs. The estimates are
discounted in order to compute net present value.
36 These grandfathered members were enrolled
without having to complete a new member
application when the WTC Health Program started
on July 1, 2011 and are referred to in the WTC
Health Program regulations in 42 CFR part 88 as
‘‘currently identified responders’’ and ‘‘currently
identified survivors.’’
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December 1, 2015, 8,177 new
responders and 4,586 new survivors
(12,763 total) enrolled in the WTC
Health Program. For the purpose of
calculating a baseline estimate of newonset COPD and WTC-related acute
traumatic injury prevalence, the
Administrator projected that new
enrollment would be approximately
4,000 per year (2,800 new responders
and 1,200 new survivors), based on the
trend in enrollees through December 1,
2015.
CCE or NPN physicians will conduct
medical assessments for patients as
appropriate and make a determination,
which the Administrator will then use
to certify or not certify the health
condition (in this case, new-onset COPD
or a type of WTC-related acute traumatic
injury) for treatment by the WTC Health
Program. However, for the purpose of
this analysis, the Administrator has
assumed that all diagnosed cases of
new-onset COPD and acute traumatic
injury will be certified for treatment by
the WTC Health Program. Finally,
because there are no existing data on
new-onset COPD rates related to 9/11
exposures at either the Pentagon or
Shanksville, Pennsylvania sites, and
only limited data on acute traumatic
injuries at the Pentagon, the
Administrator has used only data from
studies of individuals who were
responders or survivors in the New York
City area.
Prevalence of New-Onset COPD
To estimate the number of potential
cases of WTC-related new-onset COPD
to be certified for treatment by the WTC
Health Program, we first subtracted the
number of current members certified for
an obstructive airways disease (OAD),
including WTC-exacerbated COPD, from
the total number of members.37 We then
reviewed the surveillance literature to
determine a prevalence rate for newonset COPD among the non-OAD
certified members. In studies of FDNY
members with known pre-9/11 health
status and high WTC exposure, Aldrich
et al. reported that 2 percent of FDNY
firefighters had an FEV1% below 70
percent of predicted 38 at year 1 after
September 11, 2001 (a proportion that
doubled 6.5 years later), and Webber et
al.39 reported an approximate 4 percent
prevalence of new-onset, self-reported,
physician-diagnosed COPD/emphysema
nearly ten years after rescue/recovery
efforts at the WTC site. Because pre-9/
11 health records were not available in
studies of WTC survivors, the
Administrator has determined that the 4
percent prevalence of new-onset COPD
will be applied to survivor estimates as
well.40 We applied the 4 percent
prevalence to the number of remaining
members and also to the projected
annual enrollment of 4,000 new
members to estimate the number of
potential WTC-related new-onset COPD
cases in 2016. (See Table 1, below)
TABLE 1—ESTIMATED PREVALENCE OF 2016–2019 NEW-ONSET COPD CASES
2016
2017
2018
2019
Responders ......................................................................................................
Survivors ..........................................................................................................
2,106
306
2,218
354
2,330
402
2,442
450
Total ..........................................................................................................
2,412
2,572
2,732
2,892
sradovich on DSK3GDR082PROD with RULES
Prevalence of WTC-Related Acute
Traumatic Injury
While this rulemaking would make
acute traumatic injury eligible for
certification, the Administrator assumes
that the conditions most likely to
receive treatment within the WTC
Health Program will be those medically
associated conditions which are the
long-term consequences of the certified
WTC-related acute traumatic injury.
Health conditions medically associated
with WTC-related health conditions are
determined on a case-by-case basis in
accordance with WTC Health Program
regulations and policies and
procedures.41 Examples of such health
conditions medically associated with a
WTC-related acute traumatic injury may
include chronic back pain caused by
vertebrae fractures, chronic peripheral
neuropathy due to severe burns, and
problems with executive brain function
due to closed head injuries.
Although we were able to estimate
from the surveillance literature the
number of responders and survivors
who received medical treatment for
acute traumatic injuries on or in the
aftermath of September 11, 2001, we do
not know the number of individuals
who still experience health problems
because of those traumatic injuries and
are in need of chronic care. To project
this, we estimated the number of
persons in the responder and survivor
populations with WTC-related acute
traumatic injury by deriving estimates
from the Berrios-Torres et al.,42 Banauch
et al.,43 Perritt et al.,44 and NYCDOH
37 Cases of COPD diagnosed prior to September
11, 2001, are presumed to be eligible for coverage
as WTC-exacerbated COPD and therefore would not
need coverage under new-onset COPD. Members
already certified for an obstructive airway disease
are also removed from the analysis because any
progression to COPD (i.e., airflow limitation not
fully reversible with bronchodilator) from their
current certified WTC-related OAD condition could
be considered a health condition medicallyassociated with the certified WTC-related OAD
condition. See John Howard, Administrator of the
WTC Health Program, Health Conditions Medically
Associated with World Trade Center-Related Health
Conditions, revised Nov. 7, 2014, https://
www.cdc.gov/wtc/pdfs/
WTCHPMedically%20AssociatedHealthConditions7
November2014.pdf.
38 The term of art ‘‘percent of predicted’’ means
that the proportion of the patient’s vital capacity
expired in 1 second of forced expiration (FEV1%)
is less than the predicted average FEV1% in the
population for a person of similar age, sex, and
body composition. FEV1% predicted is a marker for
severity of airway obstruction. In the setting of postbronchodilator FEV1/FVC ≤0.7, FEV1% predicted
≥80 indicates mild COPD; 50–80, moderate; 30–50,
severe, and <30, very severe. See American
Thoracic Society COPD Guidelines, Spirometric
Classification, 2015, https://www.thoracic.org/copdguidelines/for-health-professionals/definitiondiagnosis-and-staging/spirometricclassification.php.
39 Mayris Webber, Michelle Glaser, Jessica
Weakley, et al., Physician-Diagnosed Respiratory
Conditions and Mental Health Symptoms 7–9 Years
Following the World Trade Center Disaster, AJIM
2011;54:661–671.
40 The 4 percent prevalence of new-onset COPD
that was observed among firefighters was used to
estimate the number of expected cases of new-onset
COPD in the entire exposed cohort and may result
in an overestimation because of the differences in
initial exposure intensity between responders and
survivors.
41 John Howard, Administrator of the WTC Health
Program, Health Conditions Medically Associated
with World Trade Center-Related Health
Conditions, revised Nov. 7, 2014, https://
www.cdc.gov/wtc/pdfs/WTCHPMedically%20
AssociatedHealthConditions7November2014.pdf.
42 Sandra Berrios-Torres, Jane Greenko, Michael
Philips, et al., World Trade Center Rescue Worker
Injury and Illness Surveillance, New York, 2001,
Am J Prev Med 2003;25(2):79–87.
43 G Banauch, M McLaughlin, R Hirschhorn, et
al., Injuries and Illnesses among New York City Fire
Department Rescue Workers after Responding to the
World Trade Center Attacks, MMWR Sept. 11,
2002;51(Special Issue):1–5.
44 Kara Perritt, Winifred Boal, The Helix Group
Inc., Injuries and Illnesses Treated at the World
Trade Center, 14 September–20 November 2001,
Prehosp Disaster Med 2005;20(3).
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studies.45 Using the estimated
prevalence for injury types, we then
calculated the prevalence for these
injuries among the responder 46 and
survivor 47 populations. We applied that
prevalence to the number of current and
expected WTC Health Program members
to find the number of individuals who
may have suffered a WTC-related acute
traumatic injury. Next, in order to
estimate the proportion of those in the
responder and survivor populations
who suffered WTC-related acute
traumatic injuries that require chronic
care, we assumed that all patients with
permanent partial and permanent total
impairment caused by acute traumatic
injuries will require chronic medical
care and will enroll in the WTC Health
Program. The National Safety Council
estimated that 3.8 percent of non-fatal
disabling injuries 48 are associated with
permanent partial or permanent total
impairment.49 We applied that estimate
to the estimated number of current and
expected WTC Health Program members
who may have suffered a WTC-related
acute traumatic injury to determine the
number of individuals with WTCrelated acute traumatic injury who are
in need of chronic care. (See Table 2,
below.)
TABLE 2—ESTIMATED PREVALENCE OF 2016–2019 WTC-RELATED ACUTE TRAUMATIC INJURY CASES
2016
2017
2018
2019
Responders ......................................................................................................
Survivors ..........................................................................................................
80
10
83
12
86
13
89
14
Total ..........................................................................................................
90
95
99
103
Costs of COPD Treatment
The Administrator estimated the
medical treatment costs associated with
new-onset COPD in this rulemaking,
using the methods described below, to
be between $1,665 and $1,930 per case
in 2014.
The low estimate, $1,665 per case,
was based on WTC Health Program
costs associated with the treatment of
WTC-exacerbated COPD for the period
October 1, 2013 through September 30,
2014. These medical costs include both
medical services and pharmaceuticals.50
The high estimate, $1,930 per case,
was based on a study by Leigh et al.51
The authors estimated the cost of
occupational COPD by aggregating and
analyzing national data sets collected by
the National Center for Health Statistics,
the Health Care Financing
Administration, and other government
agencies and private firms. They
concluded that there were an estimated
2,395,650 occupational cases of COPD
in 1996 that resulted in medical costs
estimated at $2.425 billion. Medical
costs included payments to hospitals,
physicians, nursing homes, and vendors
of medical supplies, including oxygen,
and also included the cost of
pharmaceuticals.52 The medical cost per
case was about $1,012 in 1996 dollars or
about $1,930 in 2014 dollars, after
adjusting for inflation using the Medical
Consumer Price Index for all urban
consumers.53
Table 3 below shows medical
treatment cost estimates per COPD case
in 2016–2019:
TABLE 3—ESTIMATED MEDICAL TREATMENT COSTS PER NEW-ONSET COPD CASE DURING 2016–2019 IN 2014 DOLLARS
Source
Year
WTC Health Program ......................................................................................
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Leigh et al. .......................................................................................................
45 New York City Department of Health, Rapid
Assessment of Injuries Among Survivors of the
Terrorist Attack on the World Trade Center—New
York City, September 2001, MMWR Jan. 11,
2002;51(01);1–5.
46 The responder estimate is subject to two main
assumptions. First, Banauch et al. reported on
FDNY members from September 11 to December 10,
2001, and we assume no additional injuries from
December 11, 2001 until the site was closed in July
2002. The time period reported on by Banauch et
al. likely encompasses a large majority of the
injuries suffered by FDNY members. Second, Perritt
et al. did not report directly on closed head injuries;
therefore the number of closed head injuries
reported by Berrios-Torres et al. for responders is
used.
47 We estimate the survivor prevalence from the
NYCDOH study reports on survivors during the
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Undiscounted
2016
2017
2018
2019
2016
2017
2018
2019
period from September 11–13, 2001. Although we
understand that this reporting period likely
encompasses a majority of the survivors who were
injured, because the number of cases is based on
those survivors who were treated for injuries only
within the first 48 hours after the terrorist attacks,
the reported number of cases likely underestimates
the total number of survivors who sustained acute
traumatic injuries as a result of the September 11,
2001, terrorist attacks.
48 In 2011, the National Safety Council replaced
the term ‘‘disabling injury’’ with ‘‘medically
consulted injury.’’ See National Safety Council,
Injury Facts, 2014.
49 A non-fatal disabling injury is one which
results in some degree of permanent impairment or
renders the injured person unable to effectively
perform his regular duties or activities for a full day
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$1,665
1,665
1,665
1,665
1,930
1,930
1,930
1,930
Discounted
3%
Discounted
7%
........................
$1,617
1,569
1,524
........................
1,874
1,819
1,766
........................
$1,556
1,454
1,359
........................
1,804
1,686
1,575
beyond the day of the injury. National Safety
Council, Injury Facts, 1986.
50 Pharmaceutical costs are estimated to be
approximately 38 percent of total treatment costs.
51 J. Paul Leigh, Patrick Romano, Marc Schenker,
Kathleen Kreiss, Costs of Occupational COPD and
Asthma, CHEST 2002;121(1):264–272.
52 Screening costs are not included because the
U.S. Preventive Services Task Force does not
recommend screening for COPD. See Screening for
Chronic Obstructive Pulmonary Disease Using
Spirometry, https://
www.uspreventiveservicestaskforce.org/uspstf/
uspscopd.htm.
53 Bureau of Labor Statistics, Consumer Price
Index for All Urban Consumers: Medical Care,
https://research.stlouisfed.org/fred2/series/
CPIMEDSL/downloaddata?cid=32419.
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Costs of WTC-Related Acute Traumatic
Injury Treatment
The Administrator estimated the
medical treatment costs associated with
WTC-related acute traumatic injury in
this rulemaking using the methods
described below. Because it is not
possible to identify all possible types of
acute traumatic injury for which a WTC
responder or survivor might seek
certification, we have identified several
types of acute traumatic injury that may
be representative of those types of acute
traumatic injuries that might be certified
by the WTC Health Program.
Representative examples of types of
WTC-related acute traumatic injury
include closed head injuries, burns,
fractures, strains and sprains,
orthopedic injuries (e.g., meniscus tear),
ocular injuries, and crush injuries. The
WTC Health Program estimates the cost
of providing medical treatment for
WTC-related acute traumatic injury to
be around $11,216 per case in 2014
dollars.
This cost figure was based on a study
by the National Council on
Compensation Insurance (NCCI).54 The
data source used in this study was
NCCI’s Medical Data Call (MDC). The
MDC captures transaction-level detail
on workers’ compensation medical bills
processed on or after July 1, 2010,
including dates of service, charges,
payments, procedure codes, and
diagnosis codes; pharmaceutical costs
are also included. The data used in this
study were evaluated as of March 2013
for:
• Long-term medical services provided
in 2011 and 2012 (i.e., 20 to 30 years
post injury)
• Injuries occurring between 1983 and
1990
• Claimants with dates of birth between
1920 and 1970
• States for which NCCI collects MDC 55
For individuals born during 1951–
1970, the medical cost per case was
about $11,216 in 2014 dollars, after
adjusting for inflation using the Medical
Consumer Price Index for all urban
consumers.56
Table 4 below shows medical
treatment cost estimates per acute
traumatic injury case in 2016–2019:
TABLE 4—ESTIMATED MEDICAL TREATMENT COSTS PER WTC-RELATED ACUTE TRAUMATIC INJURY CASE DURING 2016–
2019 IN 2014 DOLLARS
Source
Year
NCCI ................................................................................................................
Undiscounted
2016
2017
2018
2019
$11,216
11,216
11,216
11,216
Discounted
3%
Discounted
7%
........................
$10,890
10,572
10,264
........................
$10,482
9,796
9,156
This rulemaking is estimated to cost
the WTC Health Program from
$4,602,162 to $5,666,713 annually,
between 2016 and 2019.57 The analysis
above offers an assumption about the
number of individuals who might enroll
in the WTC Health Program and
estimates the number of new-onset
COPD and WTC-related acute traumatic
injury cases and the resulting estimated
treatment costs to the WTC Health
Program. For the purpose of computing
the treatment costs for new-onset COPD
and WTC-related acute traumatic injury,
the Administrator assumed that all of
the individuals who are diagnosed with
either condition will be certified by the
WTC Health Program for treatment
services. In the calculations found in
Tables 5 and 6, below, estimated
treatment costs were applied to the
estimated number of cases of new-onset
COPD and WTC-related acute traumatic
injury. We assumed that 9 percent of
new-onset COPD costs and 12 percent of
WTC-related acute traumatic injury
costs for responders may be covered by
workers’ compensation each year;
accordingly, we adjusted only the
responder estimates to clarify that 91
percent of COPD costs and 88 percent of
WTC-related acute traumatic injury
costs will be paid by the WTC Health
Program.58 This analysis does not
include administrative costs associated
with certifying additional diagnoses of
new-onset COPD or WTC-related acute
traumatic injury that are WTC-related
health conditions that might result from
this action. Those costs were addressed
in the interim final rule that established
regulations for the WTC Health
Program.59
Since the implementation of
provisions of the ACA on January 1,
2014, all of the members and future
members are assumed to have or have
access to medical insurance coverage
other than through the WTC Health
Program. Therefore, all treatment costs
to be paid by the WTC Health Program
through 2019 are considered transfers.
Tables 5 and 6 describe the estimated
allocation of WTC Health Program
transfer payments.
54 David Colon, The Impact of Claimant Age on
´
Late-Term Medical Costs, NCCI Research brief, Oct.
2014, https://www.ncci.com/documents/ImpactClaimant-Age-Late-Term-Med-Costs.pdf.
55 AK, AL, AR, AZ, CO, CT, DC, FL, GA, HI, IA,
ID, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, MS,
MT, NC, NE, NH, NJ, NM, NV, NY, OK, OR, RI, SC,
SD, TN, UT, VA, VT, WI, and WV.
56 Bureau of Labor Statistics, Consumer Price
Index for All Urban Consumers: Medical Care,
https://research.stlouisfed.org/fred2/series/
CPIMEDSL/downloaddata?cid=32419.
57 The low cost estimate reflects the 2016
undiscounted new-onset COPD treatment cost
estimate using WTC Health Program data from
Table 5 and the 2016 undiscounted WTC-related
acute traumatic injury treatment cost estimate from
Table 6. The high cost estimate reflects the high
new-onset COPD treatment cost estimate for 2019,
discounted at 3 percent, using data from Leigh et
al. from Table 5 and the WTC-related acute
traumatic injury treatment cost estimate for 2019,
discounted at 3 percent, from Table 6. NB: The cost
estimate provided in the NPRM included only the
years 2015 and 2016, and costs were provided in
the aggregate.
58 Workers’ compensation rates are derived from
WTC Health Program data. See WTC Health
Program, Policy and Procedures for Recoupment
and Coordination of Benefits: Workers’
Compensation Payment, revised Dec. 16, 2013,
https://www.cdc.gov/wtc/pdfs/WTCHP–PPRecoupment-WComp-16-Dec-13.pdf.
59 76 FR 38914 (July 1, 2011).
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Summary of Costs
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43521
TABLE 5—MEDICAL TREATMENT COST FOR NEW-ONSET COPD CASES DURING 2016–2019 IN 2014 DOLLARS
Source
(costs)
Year
Undiscounted
Discounted 3%
WTC Health Program .........................
Discounted 7%
Responders
2016
$1,665 * 2,106
$3,190,906.
$1,665 * 2,218
$3,360,603.
$1,665 * 2,330
$3,530,300.
$1,665 * 2,442
$3,699,996.
2017
2018
2019
* .91 =
* .91 =
$1,617 * 2,218 * .91 =
$3,263,720.
$1,569 * 2,330 * .91 =
$3,326,751.
$1,524 * 2,442 * .91 =
$3,386,663.
* .91 =
* .91 =
$1,556 * 2,218 * .91 =
$3,140,599
$1,454 * 2,330 * .91 =
$3,082,916
$1,359 * 2,442 * .91 =
$3,019,997
Survivors
2016
2017
2018
2019
$1,665
$1,665
$1,665
$1,665
*
*
*
*
306
354
402
450
=
=
=
=
$509,490.
$589,410 ........
$669,330 ........
$749,250 ........
$1,874 * 354 = $663,396 ........
$1,819 * 402 = $731,238 ........
$1,766 * 450 = $794,700 ........
$1,804 * 354 = $638,616
$1,686 * 402 = $677,772
$1,575 * 450 = $708,750
Total (low estimates)
2016
2017
2018
2019
$3,700,396.
$3,950,013 ..............................
$4,199,630 ..............................
$4,449,246 ..............................
$3,927,116 ..............................
$4,057,989 ..............................
$4,181,363 ..............................
Leigh et al. ..........................................
$3,779,215
$3,760,688
$3,728,747
Responders
2016
$1,930 * 2,106
$3,698,768.
$1,930 * 2,218
$3,895,473.
$1,930 * 2,330
$4,092,179.
$1,930 * 2,442
$4,288,885.
2017
2018
2019
* .91 =
* .91 =
$1,874 * 2,218 * .91 =
$3,782,444.
$1,819 * 2,330 * .91 =
$3,856,826.
$1,766 * 2,442 * .91 =
$3,924,441.
* .91 =
* .91 =
$1,804 * 2,218 * .91 =
$3,641,158
$1,686 * 2,330 * .91 =
$3,574,826
$1,575 * 2,442 * .91 =
$3,499,997
Survivors
2016
2017
2018
2019
$1,930
$1,930
$1,930
$1,930
*
*
*
*
306
354
402
450
=
=
=
=
$590,580.
$683,220 ........
$775,860 ........
$868,500 ........
$1,874 * 354 = $663,396 ........
$1,819 * 402 = $731,238 ........
$1,766 * 450 = $794,700 ........
$1,804 * 354 = $638,616
$1,686 * 402 = $677,772
$1,575 * 450 = $708,750
Total (high estimates)
2016
2017
2018
2019
$4,289,348.
$4,578,693 ..............................
$4,868,039 ..............................
$5,157,385 ..............................
$4,445,840 ..............................
$4,588,064 ..............................
$4,719,141 ..............................
$4,279,774
$4,252,598
$4,208,747
TABLE 6—MEDICAL TREATMENT COST FOR WTC-RELATED ACUTE TRAUMATIC INJURY CASES DURING 2016–2019 IN
2014 DOLLARS
Source
(costs)
Year
Undiscounted
Discounted 3%
NCCI .........................
Responders
2016
2017
2018
2019
sradovich on DSK3GDR082PROD with RULES
Discounted 7%
$11,216
$11,216
$11,216
$11,216
*
*
*
*
80
83
86
89
*
*
*
*
.88
.88
.88
.88
=
=
=
=
$789,606
$819,217
$848,827
$878,437
$10,890 * 83 * .88 = $795,406
$10,572 * 86 * .88 = $800,089
$10,264 * 89 * .88 = $803,876
$10,482 * 83 * .88 = $765,605
$9,796 * 86 * .88 = $741,361
$9,156 * 89 * .88 = $717,098
Survivors
2016
2017
2018
2019
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$11,216
$11,216
$11,216
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*
*
*
*
10
12
13
14
=
=
=
=
$112,160
$134,592
$145,808
$157,024
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$10,890 * 12 = $130,680 ........
$10,572 * 13 = $137,436 ........
$10,264 * 14 = $143,696 ........
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$10,482 * 12 = $125,784
$9,796 * 13 = $127,348
$9,156 * 14 = $128,184
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TABLE 6—MEDICAL TREATMENT COST FOR WTC-RELATED ACUTE TRAUMATIC INJURY CASES DURING 2016–2019 IN
2014 DOLLARS—Continued
Source
(costs)
Year
Undiscounted
Discounted 3%
Discounted 7%
Total
2016
2017
2018
2019
$901,766
$953,809
$994,635
$1,035,461
sradovich on DSK3GDR082PROD with RULES
Examination of Benefits (Health Impact)
This section describes qualitatively
the potential benefits of the rule in
terms of the expected improvements in
the health and health-related quality of
life of potential new-onset COPD or
WTC-related acute traumatic injury
patients treated through the WTC Health
Program, compared to no treatment by
the Program.
The Administrator does not have
information on the health of the
population that may have experienced
9/11 exposures and is not currently
enrolled in the WTC Health Program.
However, the Administrator assumes
that all unenrolled responders and
survivors are now covered by health
insurance (due to the ACA) 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
new-onset COPD or WTC-related acute
traumatic injury would have improved
access to care and, thereby, the Program
should produce better treatment
outcomes than in its absence. Under
other insurance plans, patients may
have deductibles, coinsurance, and
copays, which impact access to care and
timeliness of care. WTC Health Program
members who are certified for these
conditions would have first-dollar
coverage and, therefore, are likely to
seek care sooner when indicated,
resulting in improved treatment
outcomes.
Limitations
The analysis presented above was
limited by the dearth of verifiable data
on the new-onset COPD and acute
traumatic injury status of responders
and survivors who have yet to apply for
enrollment in the WTC Health Program.
Because of the limited data, the
Administrator was not able to estimate
benefits in terms of averted healthcare
costs. Nor was the Administrator able to
estimate indirect costs such as averted
absenteeism, short and long-term
disability, and productivity losses
averted due to premature mortality.
VerDate Sep<11>2014
16:06 Jul 01, 2016
Jkt 238001
$926,086 .................................
$937,525 .................................
$947,572 .................................
B. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA),
5 U.S.C. 601 et seq., requires each
agency to consider the potential impact
of its regulations on small entities
including small businesses, small
governmental units, and small not-forprofit organizations. The Administrator
believes that this 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 OMB approval of, any
regulation that requires 10 or more
people to report information to the
agency or to keep certain records. This
rule does not contain any information
collection requirements; thus, HHS has
determined that the PRA does not apply
to this rule.
D. Small Business Regulatory
Enforcement Fairness Act
As required by Congress under the
Small Business Regulatory Enforcement
Fairness Act of 1996, 5 U.S.C. 801 et
seq., HHS will report the promulgation
of this rule to Congress prior to its
effective date.
E. Unfunded Mandates Reform Act of
1995
Title II of the Unfunded Mandates
Reform Act of 1995, 2 U.S.C. 1531 et
seq., directs agencies to assess the
effects of Federal regulatory actions on
State, local, and Tribal governments,
and the private sector ‘‘other than to the
extent that such regulations incorporate
requirements specifically set forth in
law.’’ For purposes of the Unfunded
Mandates Reform Act, this rule does not
include any Federal mandate that may
result in increased annual expenditures
in excess of $100 million in 1995 dollars
by State, local, or Tribal governments in
the aggregate, or by the private sector.
However, the rule may result in an
increase in the contribution made by
New York City for treatment and
PO 00000
Frm 00060
Fmt 4700
Sfmt 4700
$891,389
$868,709
$845,282
monitoring, as required under the PHS
Act, section 3331(d)(2).
F. Executive Order 12988 (Civil Justice)
This rule has been drafted and
reviewed in accordance with Executive
Order 12988, ‘‘Civil Justice Reform,’’
and will not unduly burden the Federal
court system. This rule has been
reviewed carefully to eliminate drafting
errors and ambiguities.
G. Executive Order 13132 (Federalism)
The Administrator has reviewed this
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.’’
H. Executive Order 13045 (Protection of
Children From Environmental Health
Risks and Safety Risks)
In accordance with Executive Order
13045, the Administrator has evaluated
the environmental health and safety
effects of this rule on children. The
Administrator has determined that the
rule would have no environmental
health and safety effect on children.
I. Executive Order 13211 (Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use)
In accordance with Executive Order
13211, the Administrator has evaluated
the effects of this rule on energy supply,
distribution or use, and has determined
that the rule will not have a significant
adverse effect.
J. Plain Writing Act of 2010
Under Public Law 111–274 (October
13, 2010), 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. The
Administrator has attempted to use
E:\FR\FM\05JYR1.SGM
05JYR1
Federal Register / Vol. 81, No. 128 / Tuesday, July 5, 2016 / Rules and Regulations
plain language in promulgating this rule
consistent with the Federal Plain
Writing Act guidelines.
List of Subjects in 42 CFR Part 88
Administrative practice and
procedure, Health care, Lung diseases,
Mental health programs.
Final Rule
For the reasons discussed in the
preamble, the Department of Health and
Human Services amends 42 CFR part 88
as follows:
PART 88—WORLD TRADE CENTER
HEALTH PROGRAM
Dated: June 27, 2016.
John 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.
Sylvia M. Burwell,
Secretary, Department of Health and Human
Services.
[FR Doc. 2016–15799 Filed 7–1–16; 8:45 am]
BILLING CODE 4163–18–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 1
■
1. The authority citation for part 88 is
revised to read as follows:
[GN Docket No. 12–268, WT Docket Nos.
14–70, 05–211, RM–11395; FCC 15–80]
Authority: 42 U.S.C. 300mm to 300mm–
61, Pub. L. 111–347, 124 Stat. 3623, as
amended by Pub. L. 114–113, 129 Stat. 2242.
Updating Competitive Bidding Rules
2. In § 88.1, under the definition ‘‘List
of WTC-related health conditions,’’
revise paragraph (1)(v) and add
paragraph (5) to read as follows:
■
§ 88.1
*
Definitions.
*
*
*
*
List of WTC-Related Health Conditions
sradovich on DSK3GDR082PROD with RULES
*
*
*
*
*
(1) * * *
(v) WTC-exacerbated and new-onset
chronic obstructive pulmonary disease
(COPD).
*
*
*
*
*
(5) Acute traumatic injuries:
(i) WTC-related acute traumatic
injury: physical damage to the body
caused by and occurring immediately
after a one-time exposure to energy,
such as heat, electricity, or impact from
a crash or fall, resulting from a specific
event or incident. For a WTC responder
or screening-eligible or certified-eligible
survivors who received any medical
treatment for a WTC-related acute
traumatic injury on or before September
11, 2003, such health condition
includes:
(A) Eye injury.
(B) Burn.
(C) Head trauma.
(D) Fracture.
(E) Tendon tear.
(F) Complex sprain.
(G) Other similar acute traumatic
injuries.
(ii) [Reserved]
VerDate Sep<11>2014
16:06 Jul 01, 2016
Jkt 238001
Federal Communications
Commission.
ACTION: Final rule; announcement of
effective date.
AGENCY:
In this document, the
Commission announces that the Office
of Management and Budget (OMB)
approved on June 22, 2016, a revision to
an approved information collection to
implement modified collection
requirements on FCC Form 601,
Application for Radio Service
Authorization, contained in the Part 1
Report and Order, Updating
Competitive Bidding Rules, FCC 15–80.
This document is consistent with the
Report and Order, which stated that the
Commission would publish a document
in the Federal Register announcing
OMB approval and the effective date of
the requirements.
DATES: 47 CFR 1.2110(j), published at 80
FR 56764 on September 18, 2015 and
revised FCC Form 601, are effective on
July 5, 2016.
FOR FURTHER INFORMATION CONTACT:
Cathy Williams, Cathy.Williams@
fcc.gov, (202) 418–2918.
SUPPLEMENTARY INFORMATION: This
document announces that, on June 22,
2016, OMB approved the information
collection requirements for FCC Form
601, FCC Application for Radio Service
Authorization and 47 CFR 1.2110(j),
which was contained in Report and
Order, FCC 15–80. The OMB Control
Number is 3060–0798. The Commission
publishes this document as an
announcement of the effective date of
the requirements. If you have any
comments on the burden estimates
listed below, or how the Commission
can improve the collections and reduce
any burdens caused thereby, please
SUMMARY:
PO 00000
Frm 00061
Fmt 4700
Sfmt 4700
43523
contact Cathy Williams, Federal
Communications Commission, Room 1–
C823, 445 12th Street SW., Washington,
DC 20554. Please include the OMB
Control Number, 3060–0798, in your
correspondence. The Commission will
also accept your comments via the
Internet if you send them to PRA@
fcc.gov. To request materials in
accessible formats for people with
disabilities (Braille, large print,
electronic files, audio format), send an
email to fcc504@fcc.gov or call the
Consumer and Governmental Affairs
Bureau at (202) 418–0530 (voice), (202)
418–0432 (TTY).
Synopsis
As required by the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507),
the FCC is notifying the public that it
received OMB approval on June 22,
2016, for the information collection
requirements contained in information
collection 3060–0798. Under 5 CFR
1320, an agency may not conduct or
sponsor a collection of information
unless it displays a current, valid OMB
Control Number. No person shall be
subject to any penalty for failing to
comply with a collection of information
subject to the Paperwork Reduction Act
that does not display a current, valid
OMB Control Number. The OMB
Control Number is 3060–0798. The
foregoing document is required by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13, October 1, 1995, and 44
U.S.C. 3507.
The total annual reporting burdens
and costs for the respondents are as
follows:
OMB Control Number: 3060–0798.
OMB Approval Date: June 22, 2016.
OMB Expiration Date: June 30, 2019.
Title: FCC Application for Radio
Service Authorization: Wireless
Telecommunications Bureau
Public Safety and Homeland Security
Bureau.
Form Number: FCC Form 601.
Respondents: Individuals and
households; Business or other for profit
entities; Not for profit institutions; and
State, local or tribal government.
Number of Respondents and
Responses: 253,320 respondents and
253,320 responses.
Estimated Hours per Response: 0.5–
1.25 hours.
Frequency of Response:
Recordkeeping requirement, third party
disclosure requirement, On occasion
reporting requirement and periodic
reporting requirement.
Total Annual Burden: 222,055 hours.
Total Annual Costs: $71,306,250.
Obligation to Respond: Required to
obtain or retain benefits. The statutory
E:\FR\FM\05JYR1.SGM
05JYR1
]]>Agencies
[Federal Register Volume 81, Number 128 (Tuesday, July 5, 2016)]
[Rules and Regulations]
[Pages 43510-43523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15799]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 88
[Docket No. CDC-2015-0063, NIOSH-287]
RIN 0920-AA61
World Trade Center Health Program; Addition of New-Onset Chronic
Obstructive Pulmonary Disease and WTC-Related Acute Traumatic Injury to
the List of WTC-Related Health Conditions
AGENCY: Centers for Disease Control and Prevention, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The World Trade Center (WTC) Health Program conducted a review
of published, peer-reviewed epidemiologic studies regarding potential
evidence of chronic obstructive pulmonary disease (COPD) and acute
traumatic injury among individuals who were responders to or survivors
of the September 11, 2001, terrorist attacks. The Administrator of the
WTC Health Program (Administrator) found that these studies provide
substantial evidence to support a causal association between each of
these health conditions and 9/11 exposures. As a result, the
Administrator is publishing a final rule to add both new-onset COPD and
WTC-related acute traumatic injury to the List of WTC-Related Health
Conditions eligible for treatment coverage in the WTC Health Program.
DATES: This rule is effective on August 4, 2016.
FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Program Analyst, 1090
Tusculum Ave, MS: C-46, Cincinnati, OH 45226; telephone (855)818-1629
(this is a toll-free number); email NIOSHregs@cdc.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of Regulatory Action
B. Summary of Major Provisions
C. Costs and Benefits
II. Public Participation
III. Background
A. WTC Health Program Statutory Authority
B. Evidence Supporting the Addition of New-Onset COPD and WTC-
Related Acute Traumatic Injury to the List of WTC-Related Health
Conditions
IV. Effects of Rulemaking on Federal Agencies
V. Summary of Peer Reviews and Public Comments--New-Onset COPD
A. Peer Review
B. Public Comment
VI. Summary of Peer Reviews and Public Comments--WTC-Related Acute
Traumatic Injury
A. Peer Review
B. Public Comment
VII. How To Get Help for WTC-Related Health Conditions
VIII. Summary of Final Rule
IX. Regulatory Assessment Requirements
A. Executive Order 12866 and Executive Order 13563
B. Regulatory Flexibility Act
C. Paperwork Reduction Act
D. Small Business Regulatory Enforcement Fairness Act
E. Unfunded Mandates Reform Act of 1995
F. Executive Order 12988 (Civil Justice)
G. Executive Order 13132 (Federalism)
H. Executive Order 13045 (Protection of Children From
Environmental Health Risks and Safety Risks)
I. Executive Order 13211 (Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use)
J. Plain Writing Act of 2010
I. Executive Summary
A. Purpose of Regulatory Action
This rulemaking is being conducted in order to add new-onset COPD
and WTC-related acute traumatic injury \1\ to the List of WTC-Related
Health Conditions (List). Following the receipt of letters from the
directors of the WTC Health Program Clinical Centers of Excellence
(CCEs) and Data Centers to the WTC Health Program supporting coverage
of all cases of COPD (including new-onset COPD) and significant
traumatic injuries within the Program,\2\ the Administrator decided to
conduct literature reviews regarding COPD and acute traumatic injuries
among 9/11
[[Page 43511]]
responders and survivors. Based on the findings of those reviews, he
determined that the evidence for causal associations between 9/11
exposures and new-onset COPD and acute traumatic injury, respectively,
provides sufficient bases for the addition of both health conditions to
the List. The Administrator published a proposed rule to add new-onset
COPD and acute traumatic injury to the List on September 11, 2015,\3\
and finalizes the rule in this action.
---------------------------------------------------------------------------
\1\ The term ``WTC-related'' was not included in the proposed
definition of acute traumatic injury in the notice of proposed
rulemaking, 80 FR 54746 (Sept. 11, 2015), but has been added in the
final rule to clarify specific usage in the WTC Health Program and
better parallel ``WTC-related musculoskeletal disorder'' on the
List. The Administrator finds that revising the term results in no
substantive change from the proposed rule. See discussion infra
Section VIII.
\2\ Michael Crane, Roberto Lucchini, Jacqueline Moline, et al.,
Letter from CCE and Data Center Directors to Dori Reissman and John
Halpin, WTC Health Program Regarding ``Musculoskeletal Conditions,''
May 11, 2014; and Michael Crane, Roberto Lucchini, Jacqueline
Moline, et al., Letter from CCE and Data Center Directors to Dori
Reissman and John Halpin, WTC Health Program Regarding ``Rationale
for the Continued Certification of COPD as a World Trade Center
Related and Covered Condition,'' Apr. 22, 2014. These letters are
included in the docket for this rulemaking.
\3\ 80 FR 54746.
---------------------------------------------------------------------------
B. Summary of Major Provisions
This final rule adds new-onset COPD and WTC-related acute traumatic
injury to the List of WTC-Related Health Conditions in 42 CFR 88.1. As
of the effective date of this rule, these conditions will be eligible
for treatment by the WTC Health Program.
C. Costs and Benefits
The addition of new-onset COPD and WTC-related acute traumatic
injury to the List of WTC-Related Health Conditions through this
rulemaking is estimated to cost the WTC Health Program from $4,602,162
to $5,666,713 annually, between 2016 and 2019. All of the costs to the
WTC Health Program are transfers. Benefits to current and future WTC
Health Program members may include improved access to care and better
treatment outcomes than in the absence of Program coverage.
II. Public Participation
On September 11, 2015, the Administrator published a notice of
proposed rulemaking (NPRM) to propose the addition of new-onset COPD
and acute traumatic injury to the List in 42 CFR 88.1.\4\ The
Administrator asked peer reviewers to evaluate the scientific
literature review and Administrator's determination and invited
interested members of the public or organizations to participate in the
rulemaking by submitting written views, opinions, recommendations, and/
or data. This final rule describes feedback received from both peer
reviewers and public commenters.
---------------------------------------------------------------------------
\4\ Id.
---------------------------------------------------------------------------
A total of six peer reviewers were charged with reviewing the
Administrator's evaluation of the evidence for adding the two
conditions to the List. Three pulmonary disease experts reviewed the
evidence for the addition of new-onset COPD and three injury experts
reviewed the evidence for the addition of acute traumatic injury.
Specifically, the peer reviewers were asked to answer the following
questions:
1. Are you aware of any other studies which should be considered?
If so, please identify them.
2. Have the requirements of the Policy and Procedures for Adding
Non-Cancer Conditions to the List of WTC-Related Health Conditions \5\
appropriately been fulfilled? If not, please explain which elements are
missing or deficient.
---------------------------------------------------------------------------
\5\ John Howard, Administrator of the WTC Health Program, Policy
and Procedures for Adding Non-Cancer Conditions to the List of WTC-
Related Health Conditions, revised Oct. 21, 2014, https://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_NonCancers_21_Oct_2014.pdf.
---------------------------------------------------------------------------
3. Is the interpretation of the available data appropriate, and
does it support the conclusion? If not, please explain why.
Public comments were invited on any topic related to the proposed
rule, and specifically on the following questions:
1. Is September 11, 2003 an appropriate deadline by which an
individual must have received initial medical treatment for an acute
traumatic injury?
2. Is there evidence of acute traumatic injuries that occurred as a
result of the September 11, 2001, terrorist attacks that would not be
covered by the proposed definition? What are the types of long-term
consequences or medically associated health conditions that result from
the treatment or progression of acute traumatic injuries like those
sustained on or after September 11, 2001?
3. Are data available on the chronic care needs of individuals who
suffered acute traumatic injuries during the September 11, 2001,
terrorist attacks, and its aftermath that the Administrator can use to
estimate the number of current and future WTC Health Program members
who may seek certification of WTC-related acute traumatic injury as
well as treatment costs?
4. Are data available on the prevalence and cost estimates for new-
onset COPD?
The Administrator received 16 submissions to the rulemaking docket
from the public, including the following individuals and organizations:
10 unaffiliated commenters; one individual who is a responder or
survivor; two self-identified responders; sister non-profit
organizations dedicated to preventing and curing alpha-1 antitrypsin
deficiency and COPD; a labor union; and the WTC Health Program
Survivors and Responders Steering Committees.
The peer reviews and public comments are found in the docket for
this rulemaking. Summaries of all peer reviews and public comments, as
well as the Administrator's responses, are found below.
III. Background
A. WTC Health Program Statutory Authority
Title I of the James Zadroga 9/11 Health and Compensation Act of
2010 (Zadroga Act), Public Law 111-347, as amended by Public Law 114-
113, added Title XXXIII to the Public Health Service Act (PHS Act),\6\
establishing the WTC Health Program within the Department of Health and
Human Services (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).
---------------------------------------------------------------------------
\6\ Title XXXIII of the PHS Act is codified at 42 U.S.C. 300mm
to 300mm-61. Those portions of the Zadroga Act found in Titles II
and III of Pub. L. 111-347 do not pertain to the WTC Health Program
and are codified elsewhere.
---------------------------------------------------------------------------
All references to the Administrator of the WTC Health Program
(Administrator) in this document mean the Director of the National
Institute for Occupational Safety and Health (NIOSH) or his or her
designee. Section 3312(a)(6) of the PHS Act requires the Administrator
to conduct rulemaking to propose the addition of a health condition to
the List codified in 42 CFR 88.1.
B. Evidence Supporting the Addition of New-Onset COPD and WTC-Related
Acute Traumatic Injury to the List of WTC-Related Health Conditions
Consideration of an addition to the List may be initiated at the
Administrator's discretion \7\ or following receipt of a petition by an
interested party.\8\ Under 42 CFR 88.17, the Administrator has
established a process by which health conditions may be considered for
addition to the List of WTC-Related Health Conditions in Sec. 88.1.
Pursuant to section 3312(a)(6)(D) of the PHS Act, whenever the
Administrator determines that a condition should be proposed for
addition to the List, he is required to publish an NPRM and allow
interested parties to comment on the proposed rule.
---------------------------------------------------------------------------
\7\ PHS Act, sec. 3312(a)(6)(A); 42 CFR 88.17(b).
\8\ PHS Act, sec. 3312(a)(6)(B); 42 CFR 88.17(a).
---------------------------------------------------------------------------
[[Page 43512]]
The Administrator also follows the WTC Health Program's policy and
procedures for evaluating whether to add non-cancer health conditions
to the List of WTC-Related Health Conditions, published online in the
Policies and Procedures section of the WTC Health Program Web site.\9\
The Administrator amended the policy since it was used to conduct the
analysis of COPD and acute traumatic injury studies for the NPRM;\10\
changes to the policy are not substantive and are intended to clarify
terminology and specific procedures. The policy's descriptions of what
studies will be evaluated in the literature evidence review and
analyzed in the scientific and medical assessment have been revised to
clarify the types of studies considered peer-reviewed, published,
epidemiologic studies.\11\ The Administrator has also revised an
existing footnote regarding distinct criteria for assessing certain
conditions with immediate and observable cause and effect.\12\ These
criteria were already included in the assessment conducted for the
analysis of acute traumatic injury studies published in the NPRM.\13\
In accordance with the policy, the Administrator directed the WTC
Health Program Associate Director for Science (ADS) to conduct a review
of the scientific literature to determine if the available scientific
information on COPD and acute traumatic injury, respectively, had the
potential to provide a basis for a decision on whether to add the
conditions to the List. The literature review included published, peer-
reviewed epidemiologic studies, including direct observational
studies,\14\ about each health condition among 9/11-exposed
populations. The studies were reviewed for their relevance, quantity,
and quality to determine whether they had the potential to provide a
sufficient basis for the Administrator's decision to propose adding
each health condition to the List.
---------------------------------------------------------------------------
\9\ John Howard, Administrator of the WTC Health Program, Policy
and Procedures for Adding Non-Cancer Conditions to the List of WTC-
Related Health Conditions, revised May 11, 2016, https://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_NonCancer_Conditions_Revision_11_May_2016.pdf.
\10\ An October 2014 version of the policy was used to conduct
the review in the September 2015 NPRM. See John Howard,
Administrator of the WTC Health Program, Policy and Procedures for
Adding Non-Cancer Conditions to the List of WTC-Related Health
Conditions, revised Oct. 21, 2014, https://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_NonCancers_21_Oct_2014.pdf.
\11\ The clarification of the description of the studies was
made in response to peer review comments on the WTC-related acute
traumatic injury analysis. See discussion of these comments infra
Section VI.A.
\12\ The footnote to the policy explains that injury studies are
assessed for relevance, quantity, quality, known causation, and
onsite occurrence and that information in the studies about injuries
recorded in contemporaneous medical records and studies, combined
with known hazards and known connections between those hazards and
injury, may be useful to the Administrator's evaluation of any
support for a causal association between those exposures and the
injury. See footnote 12, John Howard, Administrator of the WTC
Health Program, Policy and Procedures for Adding Non-Cancer
Conditions to the List of WTC-Related Health Conditions, revised May
11, 2016, https://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_NonCancer_Conditions_Revision_11_May_2016.pdf.
\13\ 80 FR 54746, 54754.
\14\ See discussion of these terms infra Section IV.A.
---------------------------------------------------------------------------
After finding that the available evidence had the potential to
provide bases for the decisions, the ADS further assessed the
scientific and medical evidence to determine whether causal
associations between 9/11 exposures and new-onset COPD and acute
traumatic injury, respectively, were supported. A health condition may
be added to the List if published, peer-reviewed epidemiologic studies
provide substantial support \15\ for a causal association between 9/11
exposures and the health condition in 9/11-exposed populations.
---------------------------------------------------------------------------
\15\ The substantial evidence standard is met when the Program
assesses all of the available, relevant information and determines
with high confidence that the evidence supports its findings
regarding a causal association between the 9/11 exposure(s) and the
health condition.
---------------------------------------------------------------------------
In this case, the Administrator finds there is substantial evidence
in published, peer-reviewed epidemiologic studies that 9/11 exposures
produced chronic airway inflammation manifested by persistent lower
respiratory symptomatology and decline in pulmonary function, which
progressed to new-onset COPD in a proportion of exposed subjects in the
period since exposure, independently from any cigarette smoking among
the cohort. This evidence provides substantial support for a causal
association between 9/11 exposures and new-onset COPD.
The Administrator also finds that evidence in the published, peer-
reviewed epidemiologic studies evaluated by the ADS provides
substantial support for a causal association between 9/11 exposures and
acute traumatic injuries among responders and survivors to the
September 11, 2001, terrorist attacks.
The reviews of evidence and Administrator's determinations
concerning the addition of new-onset COPD \16\ and WTC-related acute
traumatic injury \17\ are found, in full, in the NPRM.
---------------------------------------------------------------------------
\16\ See 80 FR 54746 at 54748.
\17\ Id. at 54752-54754.
---------------------------------------------------------------------------
IV. Effects of Rulemaking on Federal Agencies
Title II of the Zadroga Act reactivated the September 11th Victim
Compensation Fund (VCF). Administered by the U.S. Department of Justice
(DOJ), the VCF provides compensation to any individual or
representative of a deceased individual who was physically injured or
killed as a result of the September 11, 2001, terrorist attacks or
during the debris removal. Eligibility criteria for compensation by the
VCF include a list of presumptively covered health conditions, which
are physical injuries determined to be WTC-related health conditions by
the WTC Health Program. Pursuant to DOJ regulations, the VCF Special
Master is required to update the list of presumptively covered
conditions when the List of WTC-Related Health Conditions in 42 CFR
88.1 is updated.\18\
---------------------------------------------------------------------------
\18\ 28 CFR 104.21(b).
---------------------------------------------------------------------------
V. Summary of Peer Reviews and Public Comments--New-Onset COPD
As discussed above in the Public Participation section, the
Administrator solicited reviews of the NPRM by three experts in the
field of pulmonary disease who provided peer review of the evidence
supporting the addition of new-onset COPD. In addition to the peer
reviews, the Administrator received submissions from public commenters.
The COPD-related peer reviews and public comments are summarized below,
and each is followed by a response from the Administrator.
A. Peer Review
First, peer reviewers were asked whether they were aware of any
other studies which should have been considered in the NPRM, with
regard to new-onset COPD. Second, the peer reviewers were asked whether
the requirements of the Policy and Procedures for Adding Non-Cancer
Conditions to the List of WTC-Related Health Conditions, described
above, had been fulfilled. Third, the peer reviewers were asked whether
the Administrator's interpretation of the evidence for new-onset COPD
was appropriate and whether it supported the decision to propose adding
new-onset COPD to the List.
Identification of Other Studies To Support the Administrator's
Determination
One new-onset COPD peer reviewer indicated that no additional
articles concerning 9/11 exposures and new-onset COPD were identified.
Two reviewers suggested additional studies
[[Page 43513]]
that the Administrator should have considered.
One reviewer suggested three additional studies for the
Administrator's consideration, two of which referenced 9/11 exposures
among WTC responders with lower respiratory symptoms. The first study,
Mauer et al.,\19\ did not include spirometry, and the second study,
Niles et al.,\20\ did not specifically address the occurrence of COPD
among the 9/11-exposed population but examined the extent to which
early post-disaster symptoms and diagnoses accurately anticipate future
healthcare needs. The third study, Lange et al.,\21\ was not an
epidemiologic study of 9/11-exposed populations, and thus was not
further considered. As stated in the NPRM preamble, only epidemiologic
studies that reported compatible new-onset, ``post-9/11 lower
respiratory symptomatology and objective measurements of airways
obstruction, such as pre- and post-9/11 spirometry with bronchodilator
administrator or IOS [impulse oscillometry] were found to exhibit
potential support'' \22\ for a recommendation to add the health
condition to the List and selected for further quality review. Since
the Mauer and Niles studies did not meet this standard, they were not
further reviewed.
---------------------------------------------------------------------------
\19\ Matthew Mauer, Karen Cummings, Rebecca Hoen, Long-Term
Respiratory Symptoms in World Trade Center Responders, Occup Med
(Lond) 2010;60(2):145-51.
\20\ Justin Niles, Mayris Webber, Hillel Cohen, et al., The
Respiratory Pyramid: From Symptoms to Disease in World Trade Center
Exposed Firefighters, Am J Ind Med 2013;56(8):870-80.
\21\ Peter Lange, Bartolome Celli, Alvar Agust[iacute], et al.,
Lung-Function Trajectories Leading to Chronic Obstructive Pulmonary
Disease, N Engl J Med 2015;373:111-122.
\22\ 80 FR 54746 at 54749.
---------------------------------------------------------------------------
The other reviewer suggested a review of the literature on non-
smoking inhalational exposures, which are responsible for 15 percent of
COPD cases, and noted that COPD can present years after relevant
exposures. The Administrator agrees that COPD attributed to
occupational and environmental exposures may present several years
after cessation of exposures; however, the matter of maximum time
intervals for the diagnosis of new-onset COPD is outside the scope of
this rulemaking and will be addressed through Program policy and
procedures.
One general comment recommended that the full search string be
included in future assessments so that reviewers can replicate the
literature search. The Administrator agrees; future assessments will
include full search strings so that reviewers may replicate the ADS's
literature review.\23\
---------------------------------------------------------------------------
\23\ In the case of COPD, the full search string consisted of
the following: (``chronic obstructive pulmonary disease'' OR
``chronic bronchitis'' OR ``pulmonary emphysema'' OR ``pulmonary
function decline'' OR ``respiratory insufficiency'' OR ``airways
obstruction'' OR ``airflow limitation'') AND (``September 11
Terrorist Attacks'' OR ``World Trade Center'' OR WTC OR ``September
11'' OR 9/11).
---------------------------------------------------------------------------
Administrator's Compliance With Established Policy and Procedures To
Add Non-Cancer Health Conditions to the List of WTC-Related Health
Conditions
All three of the new-onset COPD peer reviewers agreed that the
requirements of the policy had been fulfilled.
Administrator's Interpretation of Evidence for the Addition of New-
Onset COPD
All three new-onset COPD reviewers found that the interpretation of
the available literature was appropriate and supported the
Administrator's conclusion. One reviewer identified challenges with
establishing an operational definition of COPD and how the definition
would be applied to WTC Health Program members. The reviewer asked
whether an individual with potentially relevant symptoms (such as lower
respiratory symptoms or symptoms of chronic bronchitis) and normal
spirometry has COPD. The commenter noted that ``obstructive chronic
bronchitis,'' included in the description of COPD in the NPRM preamble,
does not appear in the Global Initiative for Chronic Obstructive Lung
Disease (GOLD) recommendations, and its inclusion in the NPRM preamble
implies that the WTC Health Program member would not be considered to
have COPD if diagnosed with chronic bronchitis in the absence of
demonstrated airflow obstruction. The reviewer also asked whether
impulse oscillometry alone can support a COPD diagnosis, and pointed
out that GOLD does not include impulse oscillometry as a diagnostic
test for COPD. Finally, the reviewer asked whether the WTC Health
Program will require identification of emphysema, included under the
COPD category, by computerized tomography (CT) scan imaging even in the
absence of demonstrated spirometric airflow obstruction.
The reviewer accurately notes the difficulties in choosing a single
definition of COPD for the purpose of this rulemaking. As discussed in
the NPRM, COPD is an umbrella term and encompasses a variety of
pulmonary conditions; various definitions exist, making the
interpretation of evidence for adding new-onset COPD to the List a
challenge. The GOLD definition of COPD, which requires spirometric
evidence of airflow limitation, was used to provide an objective
parameter to evaluate the occurrence of COPD among the 9/11-exposed
populations identified in the surveillance literature reviewed by the
ADS. Chronic obstructive bronchitis is a subtype of chronic bronchitis
associated with airflow limitation, as recognized by the National
Heart, Lung, and Blood Institute.\24\ Relying on the Merck Manual, the
NPRM preamble utilized a definition of ``obstructive chronic
bronchitis'' that emphasizes the need for spirometric evidence of
airflow obstruction.
---------------------------------------------------------------------------
\24\ See NIH, National Heart, Lung, and Blood Institute,
Executive Summary, https://www.nhlbi.nih.gov/research/reports/2011-bronchitis.
---------------------------------------------------------------------------
Diagnosis of COPD requires confirmation, using spirometry, of
airflow limitation that is not fully reversible, as well as a history
of potentially causative exposure among symptomatic individuals. In
some circumstances, in addition to spirometry, impulse oscillometry may
be presented to support the COPD diagnosis by detecting subtle changes
in a patient's airways function earlier than with conventional
spirometry.\25\
---------------------------------------------------------------------------
\25\ Christopher Cooper, Assessment of Pulmonary Function in
COPD, Semin Respir Crit Care Med 2005;26(2):246-52.
---------------------------------------------------------------------------
The WTC Health Program will provide specific instruction to
physicians regarding diagnostic standards for new-onset COPD.
Certification of cases of new-onset COPD in individual WTC Health
Program members will be decided by the Program on a case-by-case basis,
in accordance with section 3312(b)(2)(B) of the PHS Act and 42 CFR
88.13.
B. Public Comment
Support for New-Onset COPD
Many commenters expressed support for the addition of new-onset
COPD to the List. One commenter found that the Administrator presented
quality evidence that establishes a causal association between 9/11
exposures and new-onset COPD. Although some submissions only addressed
the addition of acute traumatic injury, no commenters opposed the
addition of new-onset COPD.
Additional Studies To Support the Addition of New-Onset COPD to the
List
One commenter suggested the consideration of a 2010 study by
[[Page 43514]]
Banauch et al.\26\ to support the addition of COPD to the List. Another
commenter offered a list of additional articles that should have been
reviewed.
---------------------------------------------------------------------------
\26\ Gisela Banauch, Mark Brantley, Gabriel Izbicki, et al.,
Accelerated Spirometric Decline in New York City Firefighters with
[alpha]1 -Antitrypsin Deficiency, CHEST 2010;138(5):1116-1124.
---------------------------------------------------------------------------
The Banauch study was reviewed and found to be relevant; however,
it was not selected to undergo further evidence review due to its small
number of study participants (n = 90). The papers cited by the second
commenter were reviewed during the literature review process; however,
only epidemiologic studies that reported compatible post-9/11 lower
respiratory symptomatology and objective measurements of airways
obstruction, such as pre- and post-9/11 spirometry with bronchodilator
administration or impulse oscillometry were found to exhibit potential
for a recommendation and selected for review. Two of the references
offered by the commenter, Aldrich et al. and Weakley et al., were
included in the ADS's review published in the NPRM.
VI. Summary of Peer Reviews and Public Comments--WTC-Related Acute
Traumatic Injury
As discussed above in the Public Participation section, the
Administrator solicited reviews of the NPRM by three injury experts who
provided peer review of the evidence supporting the addition of acute
traumatic injury. In addition to the peer reviews, the Administrator
received submissions from public commenters. All of the acute traumatic
injury-related peer reviews and public comments are summarized below,
and each is followed by a response from the Administrator.
A. Peer Review
First, with regard to acute traumatic injury, peer reviewers were
asked whether they were aware of any other studies which should have
been considered in the NPRM. Second, the peer reviewers were asked
whether the requirements of the Policy and Procedures for Adding Non-
Cancer Conditions to the List of WTC-Related Health Conditions,
described above, had been fulfilled. Third, the peer reviewers were
asked whether the Administrator's interpretation of the evidence for
the addition of acute traumatic injury was appropriate and whether it
supported the decision to propose adding acute traumatic injury to the
List.
Identification of Other Studies To Support the Administrator's
Determination
All three acute traumatic injury peer reviewers indicated that they
were unaware of any additional studies concerning acute traumatic
injury that should have been considered by the Administrator. One
reviewer suggested that a complete list of citations that were excluded
from the ADS's review as not relevant should have been provided to
reviewers. The Administrator agrees to make the full list of citations
identified in the literature review as well as excluded scientific
papers available to reviewers in future rule-related peer reviews.\27\
---------------------------------------------------------------------------
\27\ The table below provides the search strings used to conduct
the literature search; the full list of citations identified by the
literature search conducted by the ADS is not provided here. The
NPRM incorrectly identified search terms used in the literature
review (80 FR 54746 at 54752); the terms identified in the NPRM were
instead terms used to develop cost estimates for the Executive Order
12866 and Executive Order 13563 analysis in Section VIII.A.
---------------------------------------------------------------------------
Administrator's Compliance With Established Policy and Procedures To
Add Non-Cancer Health Conditions to the List of WTC-Related Health
Conditions
Two of the acute traumatic injury peer reviewers found that the
requirements of the policy had been fulfilled. One reviewer asked about
the intent of describing the studies discussed in the assessment as
``direct observational studies rather than epidemiologic studies,''
further asking whether it meant that causation is in question or that
rates could not be computed.
------------------------------------------------------------------------
Database Search terms Results
------------------------------------------------------------------------
PubMed......................... (``September 11 114
Terrorist Attacks''
[Mesh] OR ``World
Trade Center'' [TIAB]
OR WTC [TIAB] OR
``September 11''
[TIAB]) AND (``Wounds
and Injuries'' [Mesh]
OR ``Occupational
Injuries'' [Mesh] OR
``Cumultative Trauma
Disorders'' [Mesh] OR
Injuries [TIAB]) From
2001/09/01 to 2014/12/
31.
CINAHL......................... (``MH Wounds and 36
Injuries+'') AND
(``World Trade
Center'' OR
``September 11'').
Web of Science................. (``World Trade Center'' 147
OR ``September 11'')
AND (Injury or
injuries).
EMBASE......................... World Trade Center.mp. 191
OR September 11.mp.
AND exp injury/
(english language and
embase and yr = ``2001-
Current'').
Health & Safety Science (``World Trade Center'' 31
Abstracts. OR ``September 11'')
AND (injuries OR
injury).
NIOSHTIC-2..................... World Trade Center 22
(Title) AND Injury or
Injuries (All Fields).
------------------------------------------------------------------------
The October 2014 version of the WTC Health Program's policy and
procedures on adding non-cancers to the List used to evaluate acute
traumatic injury studies for the NPRM distinguished between those types
of epidemiologic studies that can be used to identify causal
associations between exposures and health outcomes such as diseases,
and those studies that can be used to identify causal associations
between exposures and health outcomes such as cases of injury.\28\ The
terminology ``direct observational studies'' was an attempt to use
plain language to describe the types of studies that could provide
relevant evidence of a causal association between 9/11 exposures and a
health outcome, such as an injury. However, rather than making the
intent clear, it appears that the term may be confusing. By describing
the studies used to identify certain health outcomes as ``direct
observational studies,'' the WTC Health Program intended to describe
studies which are more often referred to as ``descriptive epidemiologic
studies'' within the scientific community. As discussed above, recent
amendments to the policy clarify the terminology to mitigate confusion
regarding the types of information sources the WTC Health Program uses
to support the addition of certain health conditions to the List.\29\
---------------------------------------------------------------------------
\28\ See John Howard, Administrator of the WTC Health Program,
Policy and Procedures for Adding Non-Cancer Conditions to the List
of WTC-Related Health Conditions, revised Oct. 21, 2014, https://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_NonCancers_21_Oct_2014.pdf.
\29\ John Howard, Administrator of the WTC Health Program,
Policy and Procedures for Adding Non-Cancer Conditions to the List
of WTC-Related Health Conditions, revised May 11, 2016, https://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_NonCancer_Conditions_Revision_11_May_2016.pdf.
---------------------------------------------------------------------------
[[Page 43515]]
In accordance with both the previous and current policy and
procedures on adding non-cancers to the List used to develop this
rulemaking, the ADS searched published, peer-reviewed epidemiologic
studies of acute traumatic injuries in the 9/11-exposed population,
including studies referred to in the October 2014 policy as ``direct
observational studies.'' The epidemiologic studies reviewed for this
rulemaking to support the addition of WTC-related acute traumatic
injury to the List document that outcomes occurred because of the 9/11
exposures and, thus, can be used to establish a causal association
between the 9/11-related event, such as being struck by falling debris,
and the injury, such as a broken arm. The studies reviewed allow the
Administrator to conclude that certain types of acute traumatic injury
suffered by WTC responders and survivors were sustained during or in
the aftermath of the September 11, 2001, terrorist attacks and find
that the evidence provides substantial support for a causal association
between acute traumatic injury and 9/11 exposures.
The reviewer also found it difficult to assess adherence to the
policy because of a perceived lack of clarity with regard to the scope
of the Administrator's inquiry and suggested that injuries should be
identified as ``acute,'' ``subacute,'' and ``chronic.'' The reviewer
further questioned the distinction between a broad understanding of
injuries which are musculoskeletal in nature and the Administrator's
definition of ``acute traumatic injury'' and suggested the removal of a
statement found in the NPRM characterizing musculoskeletal disorders as
distinct from acute traumatic injuries, pointing out that many of the
types of acute traumatic injury identified by the Administrator are
musculoskeletal in nature. The reviewer suggested that the
Administrator should have better clarified the distinction between
acute and chronic traumatic injury (injuries caused by multiple
exposures over time) and recommends that such a discussion be added to
the analysis in the NPRM. Without this more robust discussion, the
reviewer questioned how the definition of acute traumatic injury will
be applied, particularly with regard to the timing of initial medical
care post-injury, diagnosis of head trauma, treatment of chronic pain,
medically associated health conditions, and pre-existing injuries.
The term ``WTC-related musculoskeletal disorder'' is defined in the
PHS Act and statements in the NPRM regarding ``musculoskeletal
disorders'' are based on, and are consistent with, the statutory
definition which sets out a clear standard for identifying chronic or
recurrent disorders of the musculoskeletal system, caused by heavy
lifting or repetitive strain.\30\ In contrast to the term ``chronic
traumatic injury,'' used by the reviewer, the Administrator defines a
``WTC-related acute traumatic injury'' as an injury that occurred
suddenly during one incident involving exposure to an external event.
The new definition of ``WTC-related acute traumatic injury'' may
capture musculoskeletal injuries which do not meet the statutory
definition of ``WTC-related musculoskeletal disorder.'' The purpose of
this action is to provide Program coverage for those injuries that do
not meet the existing definition of WTC-related musculoskeletal
disorder, such as, for example, those not caused by heavy lifting or
repetitive strain.
---------------------------------------------------------------------------
\30\ Pursuant to sec. 3312(a)(4) of the PHS Act, ``WTC-related
musculoskeletal disorder'' means a chronic or recurrent disorder of
the musculoskeletal system caused by heavy lifting or repetitive
strain on the joints or musculoskeletal system occurring during
rescue or recovery efforts in the New York City disaster area in the
aftermath of the September 11, 2001, terrorist attacks. For a WTC
responder who received any treatment for a WTC-related
musculoskeletal disorder on or before September 11, 2003, eligible
musculoskeletal disorders include: (i) Low back pain; (ii) Carpal
tunnel syndrome [CTS]; (iii) Other musculoskeletal disorders. See
also 42 CFR 88.1.
---------------------------------------------------------------------------
The reviewer's detailed questions regarding how the definition of
WTC-related acute traumatic injury will be operationalized will be
answered in forthcoming guidance to CCE and NPN physicians. Each WTC
Health Program member's health condition will be evaluated in
accordance with the Program's published policies and procedures.
Administrator's Interpretation of Evidence for the Addition of Acute
Traumatic Injuries
Two of the acute traumatic injury peer reviewers found the
Administrator's interpretation of the available data to be appropriate.
One reviewer found the presentation of data to be confusing and the
Administrator's final determination concerning the addition of acute
traumatic injury to the List unclear with regard to its scope. The
reviewer acknowledged that the ADS may have encountered difficulties
obtaining evidence of injury severity and outcomes, which the reviewer
felt were crucial to a true understanding of the chronicity or level of
injury severity, and disagreed with the Administrator's conclusion
regarding the types of acute traumatic injuries identified by the
literature. According to the reviewer, the documentation of extreme
injuries in the surveillance literature should not lead to conclusions
regarding the types of injuries and their outcomes. The reviewer
suggested various edits to the Administrator's assessment of the data,
published in the NPRM, to either omit the word ``severe'' in reference
to burns, or define it in terms of total body surface area and burn
depth, and to clarify that the severity of injury could not be
ascertained from the studies reviewed. The reviewer disagreed with the
Administrator's conclusion that an eye injury, such as corneal
abrasion, could be caused by an exposure to energy. Ultimately, the
reviewer disagreed with the Administrator's proposed definition of
acute traumatic injury and instead suggested that the Administrator
define trauma as a cause of injury. Such injuries would include all
types of traumatic events regardless of the body area or organ system
injured. Examples include, but are not limited to head injury, burns,
ocular injury, fractures, and tendon and other soft-tissue injuries.
In his evaluation of the data quality, the Administrator
acknowledged that some information was not captured by the studies, and
although he agrees that a full understanding of the severity of
injuries suffered on or after September 11, 2001 may not be gleaned
from the studies reviewed, he found that the data were sufficient to
corroborate the findings of the CCEs and Data Centers and to develop a
broad definition of ``acute traumatic injury.'' The use of the word
``severe'' to describe burns was intended to reflect the request made
by the CCE and Data Center directors, which referred to the types of
injuries they were seeing as ``significant'' and ``severe.'' As
discussed in the NPRM preamble, the types of injuries described by the
CCE and Data Center directors are those that are most likely to result
in the need for the services provided by the WTC Health Program and
thus are those that the Administrator intended to capture by adding
this health condition to the List. However, the Administrator agrees
that the word ``severe'' is not defined, either in the surveillance
literature or by the Administrator in the NPRM preamble. The word
``severe,'' as used to describe burns in the proposed definition of
``acute traumatic injury,'' is stricken from the final regulatory text
in response to this review.
The Administrator's intent is to add coverage of acute traumatic
injury caused by 9/11 exposures. The reviewer's proposal incorporates
all types of trauma, including chronic or
[[Page 43516]]
recurrent disorders of the musculoskeletal system, caused by heavy
lifting or repetitive strain, which are already covered for responders
by the Program under the PHS Act's definition of ``WTC-related
musculoskeletal disorder.'' The edits proposed by the reviewer would
not substantively alter the evaluation of the available literature or
the Administrator's determination that the available scientific
evidence supports adding WTC-related acute traumatic injury to the
List.
The Administrator based the regulatory definition of WTC-related
acute traumatic injury on several established definitions, including
the definition used by the NIOSH Traumatic Injury Program which was
accepted by the National Academy of Sciences in 2008.\31\ The
regulatory definition is intended to address the etiology of the
injury--that is, that it occurred as the result of a single incident.
The incident, characterized by an ``exposure to energy,'' could include
the movement of dust particles across the surface of the cornea, and
result in an eye injury, such as a corneal abrasion. Because subacute
and chronic conditions describe further stages after the injury has
occurred, adding these additional categorizations to the regulatory
definition is unnecessary. The regulatory definition includes all acute
injuries that meet the definition.
---------------------------------------------------------------------------
\31\ Committee to Review the NIOSH Traumatic Injury Research
Program, Institute of Medicine and National Research Council,
Traumatic Injury Research at NIOSH, 2009, https://www.nap.edu/catalog/12459/traumatic-injury-research-at-niosh.
---------------------------------------------------------------------------
The reviewer also asserted that the September 11, 2003 treatment
cut-off ``seems excessively long for most types of acute trauma but too
short for others,'' and is not supported by evidence. According to the
reviewer, the data presented in the NPRM demonstrated that most acute
traumatic injuries were treated within hours of being sustained,
although traumatic brain injuries may not have been identified for
years after the event.
The Administrator agrees that the evidence reviewed in the NPRM
demonstrates that most acute traumatic injuries were treated soon after
they were sustained. The end date for initial treatment is well beyond
the response and recovery period for the three sites and generously
allows for delays in seeking treatment. The Administrator acknowledges
that most responders and survivors who sustained acute traumatic
injuries would have received medical treatment long before September
11, 2003. The reviewer also accurately points out that numerous cases
of traumatic brain injury (TBI) identified in the Rutland-Brown paper,
included in the ADS's review published in the NPRM,\32\ were not
diagnosed as TBI within 3 years of the exposure. However, each of these
persons was admitted to a hospital for injuries/illnesses related to
the September 11, 2001, terrorist attacks and treated for head injury
or major trauma, but was not diagnosed with TBI at the time they
initially received medical care. The regulatory text does not require
the member to have been diagnosed with a TBI on or before September 11,
2003, only that he or she received medical attention for an acute
traumatic injury by that date. When operationalizing the addition of
WTC-related acute traumatic injury, the Program will ensure that this
is clearly explained to the CCEs and the NPN. The Administrator finds
that the September 11, 2003 deadline is consistent with the evidence
presented in the NPRM and is neither too long nor too short for its
intended purpose of offering a reasonable amount of time in which to
expect that an injury sustained on or after September 11, 2001 was
treated. As discussed in the NPRM preamble, the decision was made to
set the end-date because this was the date used to identify traumatic
injuries eligible for treatment in the WTC Medical Monitoring and
Treatment Program that preceded the WTC Health Program; moreover, the
PHS Act uses this date as the treatment cut-off date to identify
musculoskeletal disorders eligible for certification in responders.
---------------------------------------------------------------------------
\32\ See 80 FR 54746 at 54753.
---------------------------------------------------------------------------
Finally, the reviewer found that the examples of acute traumatic
injuries identified in the NPRM Summary of Proposed Rule were
unnecessary and confusing, appearing to attribute ``causality to non-
causal events.'' With regard to the examples of acute traumatic injury
offered in the Summary of Proposed Rule, the Administrator agrees; the
sentence could be construed as not differentiating between causes and
outcomes. This language was used in the Summary of Proposed Rule
section of the NPRM preamble not to attribute causation, but to
illustrate the types of injuries that the Program would find ``acute''
and ``traumatic.'' This language is removed from the final rule and the
Administrator will provide Program guidance to CCE and NPN physicians
on the identification of acute traumatic injuries that could be
considered WTC-related.
B. Public Comment
Support for Acute Traumatic Injuries
Nearly all commenters expressed support for the addition of acute
traumatic injury to the List. Although some submissions only addressed
the addition of new-onset COPD, no commenters opposed the addition of
acute traumatic injury.
Acute Traumatic Injury Medical Care Cut-off Date
One commenter offered support for the September 11, 2003 cut-off
date. Three commenters expressed concern about the proposal to require
responders or survivors who seek certification for an acute traumatic
injury to have received medical care prior to September 11, 2003.
Commenters suggested that the time period should be replaced with a
simple requirement that the injury had to have been documented in
medical records, even if the member did not receive treatment for the
acute traumatic injury. Alternatively, commenters suggested that the
September 11, 2003 date should be pushed back to 2004 to accommodate
those responders or survivors who may not have recognized the extent of
their injuries and, therefore, did not seek treatment prior to
September 11, 2003, or those who either lost their medical records or
can no longer obtain them from emergency rooms or private physicians.
Requiring only that the acute traumatic injury appear in the WTC
Health Program member's medical record, regardless of treatment, would
not accomplish the Administrator's intent to ensure, to the extent
possible, that the member's acute traumatic injury was sustained during
or in the aftermath of the September 11, 2001, terrorist attacks. By
requiring that members demonstrate that they received timely treatment
for acute traumatic injuries, the Administrator will better be able to
establish a medical history linking the member's current chronic injury
or medically associated health condition to an acute traumatic injury
that resulted from that individual's 9/11 exposure. As discussed above,
the Administrator has determined that the September 11, 2003 cut-off
date for medical treatment is supported, and has not identified any
evidence to support extending the cut-off date for another year.
Medically Associated Health Conditions
Two submissions addressed the matter of health conditions medically
associated with WTC-related acute traumatic injury. One commenter
offered a first-hand account of the
[[Page 43517]]
health conditions he incurred as a result of the September 11, 2001,
terrorist attacks, suggesting that he still suffers from medically
associated conditions. The other commenter expressed concern that
health conditions medically associated with WTC-related health
conditions were not specifically addressed in the NPRM, particularly
with regard to acute traumatic injury.
Health conditions medically associated with WTC-related health
conditions were briefly addressed in the NPRM.\33\ The Administrator
expects that many Program members who experienced an acute traumatic
injury may no longer be dealing with the primary injury, but are in
need of ongoing medical care for chronic conditions stemming from the
original injury. For example, a WTC responder may have suffered a head
trauma during response activities which was resolved years ago, but may
still be coping with the long-term effects of TBI. Once WTC-related
acute traumatic injury is added to the List, the WTC responder's TBI
may be eligible for certification as a condition medically associated
with the WTC-related acute traumatic injury, head trauma. Health
conditions medically associated with a WTC-related health condition are
determined by the Program on a case-by-case basis, in accordance with
published Program regulations and policies and procedures.
---------------------------------------------------------------------------
\33\ See 80 FR 54746 at 54756.
---------------------------------------------------------------------------
VII. How To Get Help for WTC-Related Health Conditions
One commenter described suffering from untreated, chronic health
issues that may stem from work at Ground Zero. Although this comment
was not directly related to the rulemaking, the Administrator wants to
remind individuals who may have responded to or survived the September
11, 2001, terrorist attacks, that the WTC Health Program provides
medical monitoring and treatment for WTC-related health conditions. An
individual may apply to become a WTC Health Program member by filling
out the appropriate application, available on the Program's Web site
here: https://www.cdc.gov/wtc/apply.html (call 1-888-982-4748 to discuss
the application process).
VIII. Summary of Final Rule
For the reasons discussed above and in the NPRM, the Administrator
amends 42 CFR 88.1, ``List of WTC-related health conditions,''
paragraph (1)(v), to add ``new-onset'' COPD to the existing ``WTC-
exacerbated chronic obstructive pulmonary disease (COPD).'' This will
permit the WTC Health Program to certify cases of COPD determined to
have been caused or contributed to by 9/11 exposures (considered ``new-
onset'' cases), in addition to those cases of COPD which were
exacerbated by 9/11 exposures and which are already included on the
List.
For the reasons discussed above, the Administrator also adds ``WTC-
related acute traumatic injury'' to the List for WTC responders and
screening- and certified-eligible survivors who received medical
treatment for such an injury on or before September 11, 2003. The term
``WTC-related acute traumatic injury'' is defined as a type of injury
characterized by physical damage to a person's body that must have been
caused by and occurred immediately after exposure to hazards or adverse
conditions characterized by a one-time exposure to energy resulting
from the terrorist attacks or their aftermath. This requirement is
intended to distinguish these types of injuries from musculoskeletal
disorders, which are already included on the List of WTC-Related Health
Conditions. As required by statute, WTC-related musculoskeletal
disorders are considered to be caused by repetitive motion or heavy
lifting; the health condition ``WTC-related acute traumatic injury''
requires a demonstration of causation by a specific event or incident.
Symptoms of acute traumatic injuries may not immediately manifest after
the specific event or incident. The Administrator will issue guidance
to CCE and NPN physicians on the identification of WTC-related acute
traumatic injury. WTC-related acute traumatic injury includes, but is
not limited to the following: Eye injury; burn; head trauma; fracture;
tendon tear; complex sprain; and other similar injuries. The term
``WTC-related'' was not included in the term proposed in the NPRM;
however, the Administrator finds that adding it would result in no
substantive change from the proposed rule. It would be in keeping with
the existing definition of ``WTC-related musculoskeletal disorder'' and
would also signal that this language was developed specifically for the
purposes of the WTC Health Program. Finally, to clarify the
Administrator's intent, the regulatory text is reorganized slightly
from that which was proposed. The reorganization has no substantive
effect.
IX. Regulatory Assessment Requirements
A. Executive Order 12866 and Executive Order 13563
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 13563 emphasizes the importance of quantifying both costs and
benefits, reducing costs, harmonizing rules, and promoting flexibility.
This rulemaking has been determined not to be a ``significant
regulatory action'' under section 3(f) of Executive Order 12866. This
rule adds new-onset COPD \34\ and WTC-related acute traumatic injury to
the List of WTC-Related Health Conditions established in 42 CFR 88.1.
This rulemaking is estimated to cost the WTC Health Program from
$4,602,162 to $5,666,713 annually, between 2016 and 2019.\35\ All of
the costs to the WTC Health Program will be transfers due to the
implementation of provisions of the Patient Protection and Affordable
Care Act (ACA) (Pub. L. 111-148) on January 1, 2014. This rulemaking
has not been reviewed by the Office of Management and Budget (OMB). The
rule would not interfere with State, local, and Tribal governments in
the exercise of their governmental functions.
---------------------------------------------------------------------------
\34\ WTC-exacerbated COPD is a statutorily covered condition
pursuant to PHS Act, sec. 3312(a)(3)(A)(v); this NPRM proposes to
add new-onset COPD occurring after 9/11 exposures.
\35\ The low cost estimate reflects the 2016 undiscounted new-
onset COPD treatment cost estimate using WTC Health Program data
from Table 5 and the 2016 undiscounted WTC-related acute traumatic
injury treatment cost estimate from Table 6. The high cost estimate
reflects the high new-onset COPD treatment cost estimate for 2019,
discounted at 3 percent, using data from Leigh et al. from Table 5
and the WTC-related acute traumatic injury treatment cost estimate
for 2019, discounted at 3 percent, from Table 6. Future cost and
prevalence estimates are discounted at 3% and 7% in accordance with
OMB Circular A-94, Guidelines and Discount Rates for Benefit-Cost
Analysis of Federal Programs. The estimates are discounted in order
to compute net present value.
---------------------------------------------------------------------------
Population Estimates
As of December 1, 2015, the WTC Health Program had enrolled 64,384
responders and 9,358 survivors (73,742 total). Of that total
population, 56,207 responders and 4,772 survivors (60,979 total) were
participants in previous WTC medical programs and were `grandfathered'
into the WTC Health Program established by Title XXXIII of the PHS
Act.\36\ From July 1, 2011 to
[[Page 43518]]
December 1, 2015, 8,177 new responders and 4,586 new survivors (12,763
total) enrolled in the WTC Health Program. For the purpose of
calculating a baseline estimate of new-onset COPD and WTC-related acute
traumatic injury prevalence, the Administrator projected that new
enrollment would be approximately 4,000 per year (2,800 new responders
and 1,200 new survivors), based on the trend in enrollees through
December 1, 2015.
---------------------------------------------------------------------------
\36\ These grandfathered members were enrolled without having to
complete a new member application when the WTC Health Program
started on July 1, 2011 and are referred to in the WTC Health
Program regulations in 42 CFR part 88 as ``currently identified
responders'' and ``currently identified survivors.''
---------------------------------------------------------------------------
CCE or NPN physicians will conduct medical assessments for patients
as appropriate and make a determination, which the Administrator will
then use to certify or not certify the health condition (in this case,
new-onset COPD or a type of WTC-related acute traumatic injury) for
treatment by the WTC Health Program. However, for the purpose of this
analysis, the Administrator has assumed that all diagnosed cases of
new-onset COPD and acute traumatic injury will be certified for
treatment by the WTC Health Program. Finally, because there are no
existing data on new-onset COPD rates related to 9/11 exposures at
either the Pentagon or Shanksville, Pennsylvania sites, and only
limited data on acute traumatic injuries at the Pentagon, the
Administrator has used only data from studies of individuals who were
responders or survivors in the New York City area.
Prevalence of New-Onset COPD
To estimate the number of potential cases of WTC-related new-onset
COPD to be certified for treatment by the WTC Health Program, we first
subtracted the number of current members certified for an obstructive
airways disease (OAD), including WTC-exacerbated COPD, from the total
number of members.\37\ We then reviewed the surveillance literature to
determine a prevalence rate for new-onset COPD among the non-OAD
certified members. In studies of FDNY members with known pre-9/11
health status and high WTC exposure, Aldrich et al. reported that 2
percent of FDNY firefighters had an FEV1% below 70 percent of predicted
\38\ at year 1 after September 11, 2001 (a proportion that doubled 6.5
years later), and Webber et al.\39\ reported an approximate 4 percent
prevalence of new-onset, self-reported, physician-diagnosed COPD/
emphysema nearly ten years after rescue/recovery efforts at the WTC
site. Because pre-9/11 health records were not available in studies of
WTC survivors, the Administrator has determined that the 4 percent
prevalence of new-onset COPD will be applied to survivor estimates as
well.\40\ We applied the 4 percent prevalence to the number of
remaining members and also to the projected annual enrollment of 4,000
new members to estimate the number of potential WTC-related new-onset
COPD cases in 2016. (See Table 1, below)
---------------------------------------------------------------------------
\37\ Cases of COPD diagnosed prior to September 11, 2001, are
presumed to be eligible for coverage as WTC-exacerbated COPD and
therefore would not need coverage under new-onset COPD. Members
already certified for an obstructive airway disease are also removed
from the analysis because any progression to COPD (i.e., airflow
limitation not fully reversible with bronchodilator) from their
current certified WTC-related OAD condition could be considered a
health condition medically-associated with the certified WTC-related
OAD condition. See John Howard, Administrator of the WTC Health
Program, Health Conditions Medically Associated with World Trade
Center-Related Health Conditions, revised Nov. 7, 2014, https://www.cdc.gov/wtc/pdfs/WTCHPMedically%20AssociatedHealthConditions7November2014.pdf.
\38\ The term of art ``percent of predicted'' means that the
proportion of the patient's vital capacity expired in 1 second of
forced expiration (FEV1%) is less than the predicted average FEV1%
in the population for a person of similar age, sex, and body
composition. FEV1% predicted is a marker for severity of airway
obstruction. In the setting of post-bronchodilator FEV1/FVC <=0.7,
FEV1% predicted >=80 indicates mild COPD; 50-80, moderate; 30-50,
severe, and <30, very severe. See American Thoracic Society COPD
Guidelines, Spirometric Classification, 2015, https://www.thoracic.org/copd-guidelines/for-health-professionals/definition-diagnosis-and-staging/spirometric-classification.php.
\39\ Mayris Webber, Michelle Glaser, Jessica Weakley, et al.,
Physician-Diagnosed Respiratory Conditions and Mental Health
Symptoms 7-9 Years Following the World Trade Center Disaster, AJIM
2011;54:661-671.
\40\ The 4 percent prevalence of new-onset COPD that was
observed among firefighters was used to estimate the number of
expected cases of new-onset COPD in the entire exposed cohort and
may result in an overestimation because of the differences in
initial exposure intensity between responders and survivors.
Table 1--Estimated Prevalence of 2016-2019 New-Onset COPD Cases
----------------------------------------------------------------------------------------------------------------
2016 2017 2018 2019
----------------------------------------------------------------------------------------------------------------
Responders...................................... 2,106 2,218 2,330 2,442
Survivors....................................... 306 354 402 450
---------------------------------------------------------------
Total....................................... 2,412 2,572 2,732 2,892
----------------------------------------------------------------------------------------------------------------
Prevalence of WTC-Related Acute Traumatic Injury
While this rulemaking would make acute traumatic injury eligible
for certification, the Administrator assumes that the conditions most
likely to receive treatment within the WTC Health Program will be those
medically associated conditions which are the long-term consequences of
the certified WTC-related acute traumatic injury. Health conditions
medically associated with WTC-related health conditions are determined
on a case-by-case basis in accordance with WTC Health Program
regulations and policies and procedures.\41\ Examples of such health
conditions medically associated with a WTC-related acute traumatic
injury may include chronic back pain caused by vertebrae fractures,
chronic peripheral neuropathy due to severe burns, and problems with
executive brain function due to closed head injuries.
---------------------------------------------------------------------------
\41\ John Howard, Administrator of the WTC Health Program,
Health Conditions Medically Associated with World Trade Center-
Related Health Conditions, revised Nov. 7, 2014, https://www.cdc.gov/wtc/pdfs/WTCHPMedically%20AssociatedHealthConditions7November2014.pdf.
---------------------------------------------------------------------------
Although we were able to estimate from the surveillance literature
the number of responders and survivors who received medical treatment
for acute traumatic injuries on or in the aftermath of September 11,
2001, we do not know the number of individuals who still experience
health problems because of those traumatic injuries and are in need of
chronic care. To project this, we estimated the number of persons in
the responder and survivor populations with WTC-related acute traumatic
injury by deriving estimates from the Berrios-Torres et al.,\42\
Banauch et al.,\43\ Perritt et al.,\44\ and NYCDOH
[[Page 43519]]
studies.\45\ Using the estimated prevalence for injury types, we then
calculated the prevalence for these injuries among the responder \46\
and survivor \47\ populations. We applied that prevalence to the number
of current and expected WTC Health Program members to find the number
of individuals who may have suffered a WTC-related acute traumatic
injury. Next, in order to estimate the proportion of those in the
responder and survivor populations who suffered WTC-related acute
traumatic injuries that require chronic care, we assumed that all
patients with permanent partial and permanent total impairment caused
by acute traumatic injuries will require chronic medical care and will
enroll in the WTC Health Program. The National Safety Council estimated
that 3.8 percent of non-fatal disabling injuries \48\ are associated
with permanent partial or permanent total impairment.\49\ We applied
that estimate to the estimated number of current and expected WTC
Health Program members who may have suffered a WTC-related acute
traumatic injury to determine the number of individuals with WTC-
related acute traumatic injury who are in need of chronic care. (See
Table 2, below.)
---------------------------------------------------------------------------
\42\ Sandra Berrios-Torres, Jane Greenko, Michael Philips, et
al., World Trade Center Rescue Worker Injury and Illness
Surveillance, New York, 2001, Am J Prev Med 2003;25(2):79-87.
\43\ G Banauch, M McLaughlin, R Hirschhorn, et al., Injuries and
Illnesses among New York City Fire Department Rescue Workers after
Responding to the World Trade Center Attacks, MMWR Sept. 11,
2002;51(Special Issue):1-5.
\44\ Kara Perritt, Winifred Boal, The Helix Group Inc., Injuries
and Illnesses Treated at the World Trade Center, 14 September-20
November 2001, Prehosp Disaster Med 2005;20(3).
\45\ New York City Department of Health, Rapid Assessment of
Injuries Among Survivors of the Terrorist Attack on the World Trade
Center--New York City, September 2001, MMWR Jan. 11, 2002;51(01);1-
5.
\46\ The responder estimate is subject to two main assumptions.
First, Banauch et al. reported on FDNY members from September 11 to
December 10, 2001, and we assume no additional injuries from
December 11, 2001 until the site was closed in July 2002. The time
period reported on by Banauch et al. likely encompasses a large
majority of the injuries suffered by FDNY members. Second, Perritt
et al. did not report directly on closed head injuries; therefore
the number of closed head injuries reported by Berrios-Torres et al.
for responders is used.
\47\ We estimate the survivor prevalence from the NYCDOH study
reports on survivors during the period from September 11-13, 2001.
Although we understand that this reporting period likely encompasses
a majority of the survivors who were injured, because the number of
cases is based on those survivors who were treated for injuries only
within the first 48 hours after the terrorist attacks, the reported
number of cases likely underestimates the total number of survivors
who sustained acute traumatic injuries as a result of the September
11, 2001, terrorist attacks.
\48\ In 2011, the National Safety Council replaced the term
``disabling injury'' with ``medically consulted injury.'' See
National Safety Council, Injury Facts, 2014.
\49\ A non-fatal disabling injury is one which results in some
degree of permanent impairment or renders the injured person unable
to effectively perform his regular duties or activities for a full
day beyond the day of the injury. National Safety Council, Injury
Facts, 1986.
Table 2--Estimated Prevalence of 2016-2019 WTC-Related Acute Traumatic Injury Cases
----------------------------------------------------------------------------------------------------------------
2016 2017 2018 2019
----------------------------------------------------------------------------------------------------------------
Responders...................................... 80 83 86 89
Survivors....................................... 10 12 13 14
---------------------------------------------------------------
Total....................................... 90 95 99 103
----------------------------------------------------------------------------------------------------------------
Costs of COPD Treatment
The Administrator estimated the medical treatment costs associated
with new-onset COPD in this rulemaking, using the methods described
below, to be between $1,665 and $1,930 per case in 2014.
The low estimate, $1,665 per case, was based on WTC Health Program
costs associated with the treatment of WTC-exacerbated COPD for the
period October 1, 2013 through September 30, 2014. These medical costs
include both medical services and pharmaceuticals.\50\
---------------------------------------------------------------------------
\50\ Pharmaceutical costs are estimated to be approximately 38
percent of total treatment costs.
---------------------------------------------------------------------------
The high estimate, $1,930 per case, was based on a study by Leigh
et al.\51\ The authors estimated the cost of occupational COPD by
aggregating and analyzing national data sets collected by the National
Center for Health Statistics, the Health Care Financing Administration,
and other government agencies and private firms. They concluded that
there were an estimated 2,395,650 occupational cases of COPD in 1996
that resulted in medical costs estimated at $2.425 billion. Medical
costs included payments to hospitals, physicians, nursing homes, and
vendors of medical supplies, including oxygen, and also included the
cost of pharmaceuticals.\52\ The medical cost per case was about $1,012
in 1996 dollars or about $1,930 in 2014 dollars, after adjusting for
inflation using the Medical Consumer Price Index for all urban
consumers.\53\
---------------------------------------------------------------------------
\51\ J. Paul Leigh, Patrick Romano, Marc Schenker, Kathleen
Kreiss, Costs of Occupational COPD and Asthma, CHEST
2002;121(1):264-272.
\52\ Screening costs are not included because the U.S.
Preventive Services Task Force does not recommend screening for
COPD. See Screening for Chronic Obstructive Pulmonary Disease Using
Spirometry, https://www.uspreventiveservicestaskforce.org/uspstf/uspscopd.htm.
\53\ Bureau of Labor Statistics, Consumer Price Index for All
Urban Consumers: Medical Care, https://research.stlouisfed.org/fred2/series/CPIMEDSL/downloaddata?cid=32419.
---------------------------------------------------------------------------
Table 3 below shows medical treatment cost estimates per COPD case
in 2016-2019:
Table 3--Estimated Medical Treatment Costs per New-Onset COPD Case During 2016-2019 in 2014 Dollars
----------------------------------------------------------------------------------------------------------------
Source Year Undiscounted Discounted 3% Discounted 7%
----------------------------------------------------------------------------------------------------------------
WTC Health Program.............................. 2016 $1,665 .............. ..............
2017 1,665 $1,617 $1,556
2018 1,665 1,569 1,454
2019 1,665 1,524 1,359
Leigh et al..................................... 2016 1,930 .............. ..............
2017 1,930 1,874 1,804
2018 1,930 1,819 1,686
2019 1,930 1,766 1,575
----------------------------------------------------------------------------------------------------------------
[[Page 43520]]
Costs of WTC-Related Acute Traumatic Injury Treatment
The Administrator estimated the medical treatment costs associated
with WTC-related acute traumatic injury in this rulemaking using the
methods described below. Because it is not possible to identify all
possible types of acute traumatic injury for which a WTC responder or
survivor might seek certification, we have identified several types of
acute traumatic injury that may be representative of those types of
acute traumatic injuries that might be certified by the WTC Health
Program. Representative examples of types of WTC-related acute
traumatic injury include closed head injuries, burns, fractures,
strains and sprains, orthopedic injuries (e.g., meniscus tear), ocular
injuries, and crush injuries. The WTC Health Program estimates the cost
of providing medical treatment for WTC-related acute traumatic injury
to be around $11,216 per case in 2014 dollars.
This cost figure was based on a study by the National Council on
Compensation Insurance (NCCI).\54\ The data source used in this study
was NCCI's Medical Data Call (MDC). The MDC captures transaction-level
detail on workers' compensation medical bills processed on or after
July 1, 2010, including dates of service, charges, payments, procedure
codes, and diagnosis codes; pharmaceutical costs are also included. The
data used in this study were evaluated as of March 2013 for:
---------------------------------------------------------------------------
\54\ David Col[oacute]n, The Impact of Claimant Age on Late-Term
Medical Costs, NCCI Research brief, Oct. 2014, https://www.ncci.com/documents/Impact-Claimant-Age-Late-Term-Med-Costs.pdf.
Long-term medical services provided in 2011 and 2012 (i.e., 20
to 30 years post injury)
Injuries occurring between 1983 and 1990
Claimants with dates of birth between 1920 and 1970
States for which NCCI collects MDC \55\
---------------------------------------------------------------------------
\55\ AK, AL, AR, AZ, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS,
KY, LA, MA, MD, ME, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OK,
OR, RI, SC, SD, TN, UT, VA, VT, WI, and WV.
For individuals born during 1951-1970, the medical cost per case
was about $11,216 in 2014 dollars, after adjusting for inflation using
the Medical Consumer Price Index for all urban consumers.\56\
---------------------------------------------------------------------------
\56\ Bureau of Labor Statistics, Consumer Price Index for All
Urban Consumers: Medical Care, https://research.stlouisfed.org/fred2/series/CPIMEDSL/downloaddata?cid=32419.
---------------------------------------------------------------------------
Table 4 below shows medical treatment cost estimates per acute
traumatic injury case in 2016-2019:
Table 4--Estimated Medical Treatment Costs per WTC-Related Acute Traumatic Injury Case During 2016-2019 in 2014
Dollars
----------------------------------------------------------------------------------------------------------------
Source Year Undiscounted Discounted 3% Discounted 7%
----------------------------------------------------------------------------------------------------------------
NCCI............................................ 2016 $11,216 .............. ..............
2017 11,216 $10,890 $10,482
2018 11,216 10,572 9,796
2019 11,216 10,264 9,156
----------------------------------------------------------------------------------------------------------------
Summary of Costs
This rulemaking is estimated to cost the WTC Health Program from
$4,602,162 to $5,666,713 annually, between 2016 and 2019.\57\ The
analysis above offers an assumption about the number of individuals who
might enroll in the WTC Health Program and estimates the number of new-
onset COPD and WTC-related acute traumatic injury cases and the
resulting estimated treatment costs to the WTC Health Program. For the
purpose of computing the treatment costs for new-onset COPD and WTC-
related acute traumatic injury, the Administrator assumed that all of
the individuals who are diagnosed with either condition will be
certified by the WTC Health Program for treatment services. In the
calculations found in Tables 5 and 6, below, estimated treatment costs
were applied to the estimated number of cases of new-onset COPD and
WTC-related acute traumatic injury. We assumed that 9 percent of new-
onset COPD costs and 12 percent of WTC-related acute traumatic injury
costs for responders may be covered by workers' compensation each year;
accordingly, we adjusted only the responder estimates to clarify that
91 percent of COPD costs and 88 percent of WTC-related acute traumatic
injury costs will be paid by the WTC Health Program.\58\ This analysis
does not include administrative costs associated with certifying
additional diagnoses of new-onset COPD or WTC-related acute traumatic
injury that are WTC-related health conditions that might result from
this action. Those costs were addressed in the interim final rule that
established regulations for the WTC Health Program.\59\
---------------------------------------------------------------------------
\57\ The low cost estimate reflects the 2016 undiscounted new-
onset COPD treatment cost estimate using WTC Health Program data
from Table 5 and the 2016 undiscounted WTC-related acute traumatic
injury treatment cost estimate from Table 6. The high cost estimate
reflects the high new-onset COPD treatment cost estimate for 2019,
discounted at 3 percent, using data from Leigh et al. from Table 5
and the WTC-related acute traumatic injury treatment cost estimate
for 2019, discounted at 3 percent, from Table 6. NB: The cost
estimate provided in the NPRM included only the years 2015 and 2016,
and costs were provided in the aggregate.
\58\ Workers' compensation rates are derived from WTC Health
Program data. See WTC Health Program, Policy and Procedures for
Recoupment and Coordination of Benefits: Workers' Compensation
Payment, revised Dec. 16, 2013, https://www.cdc.gov/wtc/pdfs/WTCHP-PP-Recoupment-WComp-16-Dec-13.pdf.
\59\ 76 FR 38914 (July 1, 2011).
---------------------------------------------------------------------------
Since the implementation of provisions of the ACA on January 1,
2014, all of the members and future members are assumed to have or have
access to medical insurance coverage other than through the WTC Health
Program. Therefore, all treatment costs to be paid by the WTC Health
Program through 2019 are considered transfers. Tables 5 and 6 describe
the estimated allocation of WTC Health Program transfer payments.
[[Page 43521]]
Table 5--Medical Treatment Cost for New-Onset COPD Cases During 2016-2019 in 2014 Dollars
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source (costs) Year Undiscounted Discounted 3% Discounted 7%
--------------------------------------------------------------------------------------------------------------------------------------------------------
WTC Health Program........... Responders
--------------------------------------------------------------------------------------------------------------------------------------------------------
2016 $1,665 * 2,106 * .91 = $3,190,906...
2017 $1,665 * 2,218 * .91 = $3,360,603... $1,617 * 2,218 * .91 = $3,263,720... $1,556 * 2,218 * .91 = $3,140,599
2018 $1,665 * 2,330 * .91 = $3,530,300... $1,569 * 2,330 * .91 = $3,326,751... $1,454 * 2,330 * .91 = $3,082,916
2019 $1,665 * 2,442 * .91 = $3,699,996... $1,524 * 2,442 * .91 = $3,386,663... $1,359 * 2,442 * .91 = $3,019,997
--------------------------------------------------------------------------------------------------------------------------------------------------------
Survivors
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
2016 $1,665 * 306 = $509,490.............
2017 $1,665 * 354 = $589,410............. $1,874 * 354 = $663,396............. $1,804 * 354 = $638,616
2018 $1,665 * 402 = $669,330............. $1,819 * 402 = $731,238............. $1,686 * 402 = $677,772
2019 $1,665 * 450 = $749,250............. $1,766 * 450 = $794,700............. $1,575 * 450 = $708,750
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total (low estimates)
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
2016 $3,700,396..........................
2017 $3,950,013.......................... $3,927,116.......................... $3,779,215
2018 $4,199,630.......................... $4,057,989.......................... $3,760,688
2019 $4,449,246.......................... $4,181,363.......................... $3,728,747
--------------------------------------------------------------------------------------------------------------------------------------------------------
Leigh et al.................. Responders
--------------------------------------------------------------------------------------------------------------------------------------------------------
2016 $1,930 * 2,106 * .91 = $3,698,768...
2017 $1,930 * 2,218 * .91 = $3,895,473... $1,874 * 2,218 * .91 = $3,782,444... $1,804 * 2,218 * .91 = $3,641,158
2018 $1,930 * 2,330 * .91 = $4,092,179... $1,819 * 2,330 * .91 = $3,856,826... $1,686 * 2,330 * .91 = $3,574,826
2019 $1,930 * 2,442 * .91 = $4,288,885... $1,766 * 2,442 * .91 = $3,924,441... $1,575 * 2,442 * .91 = $3,499,997
--------------------------------------------------------------------------------------------------------------------------------------------------------
Survivors
--------------------------------------------------------------------------------------------------------------------------------------------------------
2016 $1,930 * 306 = $590,580.............
2017 $1,930 * 354 = $683,220............. $1,874 * 354 = $663,396............. $1,804 * 354 = $638,616
2018 $1,930 * 402 = $775,860............. $1,819 * 402 = $731,238............. $1,686 * 402 = $677,772
2019 $1,930 * 450 = $868,500............. $1,766 * 450 = $794,700............. $1,575 * 450 = $708,750
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total (high estimates)
--------------------------------------------------------------------------------------------------------------------------------------------------------
2016 $4,289,348..........................
2017 $4,578,693.......................... $4,445,840.......................... $4,279,774
2018 $4,868,039.......................... $4,588,064.......................... $4,252,598
2019 $5,157,385.......................... $4,719,141.......................... $4,208,747
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 6--Medical Treatment Cost for WTC-Related Acute Traumatic Injury Cases During 2016-2019 in 2014 Dollars
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source (costs) Year Undiscounted Discounted 3% Discounted 7%
--------------------------------------------------------------------------------------------------------------------------------------------------------
NCCI......................... Responders
--------------------------------------------------------------------------------------------------------------------------------------------------------
2016 $11,216 * 80 * .88 = $789,606
2017 $11,216 * 83 * .88 = $819,217 $10,890 * 83 * .88 = $795,406....... $10,482 * 83 * .88 = $765,605
2018 $11,216 * 86 * .88 = $848,827 $10,572 * 86 * .88 = $800,089....... $9,796 * 86 * .88 = $741,361
2019 $11,216 * 89 * .88 = $878,437 $10,264 * 89 * .88 = $803,876....... $9,156 * 89 * .88 = $717,098
--------------------------------------------------------------------------------------------------------------------------------------------------------
Survivors
--------------------------------------------------------------------------------------------------------------------------------------------------------
2016 $11,216 * 10 = $112,160
2017 $11,216 * 12 = $134,592 $10,890 * 12 = $130,680............. $10,482 * 12 = $125,784
2018 $11,216 * 13 = $145,808 $10,572 * 13 = $137,436............. $9,796 * 13 = $127,348
2019 $11,216 * 14 = $157,024 $10,264 * 14 = $143,696............. $9,156 * 14 = $128,184
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 43522]]
Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
2016 $901,766
2017 $953,809 $926,086............................ $891,389
2018 $994,635 $937,525............................ $868,709
2019 $1,035,461 $947,572............................ $845,282
--------------------------------------------------------------------------------------------------------------------------------------------------------
Examination of Benefits (Health Impact)
This section describes qualitatively the potential benefits of the
rule in terms of the expected improvements in the health and health-
related quality of life of potential new-onset COPD or WTC-related
acute traumatic injury patients treated through the WTC Health Program,
compared to no treatment by the Program.
The Administrator does not have information on the health of the
population that may have experienced 9/11 exposures and is not
currently enrolled in the WTC Health Program. However, the
Administrator assumes that all unenrolled responders and survivors are
now covered by health insurance (due to the ACA) 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 new-onset COPD or WTC-related
acute traumatic injury would have improved access to care and, thereby,
the Program should produce better treatment outcomes than in its
absence. Under other insurance plans, patients may have deductibles,
coinsurance, and copays, which impact access to care and timeliness of
care. WTC Health Program members who are certified for these conditions
would have first-dollar coverage and, therefore, are likely to seek
care sooner when indicated, resulting in improved treatment outcomes.
Limitations
The analysis presented above was limited by the dearth of
verifiable data on the new-onset COPD and acute traumatic injury status
of responders and survivors who have yet to apply for enrollment in the
WTC Health Program. Because of the limited data, the Administrator was
not able to estimate benefits in terms of averted healthcare costs. Nor
was the Administrator able to estimate indirect costs such as averted
absenteeism, short and long-term disability, and productivity losses
averted due to premature mortality.
B. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq.,
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. The
Administrator believes that this 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 OMB approval of,
any regulation that requires 10 or more people to report information to
the agency or to keep certain records. This rule does not contain any
information collection requirements; thus, HHS has determined that the
PRA does not apply to this rule.
D. Small Business Regulatory Enforcement Fairness Act
As required by Congress under the Small Business Regulatory
Enforcement Fairness Act of 1996, 5 U.S.C. 801 et seq., HHS will report
the promulgation of this rule to Congress prior to its effective date.
E. Unfunded Mandates Reform Act of 1995
Title II of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531
et seq., directs agencies to assess the effects of Federal regulatory
actions on State, local, and Tribal governments, and the private sector
``other than to the extent that such regulations incorporate
requirements specifically set forth in law.'' For purposes of the
Unfunded Mandates Reform Act, this rule does not include any Federal
mandate that may result in increased annual expenditures in excess of
$100 million in 1995 dollars by State, local, or Tribal governments in
the aggregate, or by the private sector. However, the rule may result
in an increase in the contribution made by New York City for treatment
and monitoring, as required under the PHS Act, section 3331(d)(2).
F. Executive Order 12988 (Civil Justice)
This rule has been drafted and reviewed in accordance with
Executive Order 12988, ``Civil Justice Reform,'' and will not unduly
burden the Federal court system. This rule has been reviewed carefully
to eliminate drafting errors and ambiguities.
G. Executive Order 13132 (Federalism)
The Administrator has reviewed this 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.''
H. Executive Order 13045 (Protection of Children From Environmental
Health Risks and Safety Risks)
In accordance with Executive Order 13045, the Administrator has
evaluated the environmental health and safety effects of this rule on
children. The Administrator has determined that the rule would have no
environmental health and safety effect on children.
I. Executive Order 13211 (Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use)
In accordance with Executive Order 13211, the Administrator has
evaluated the effects of this rule on energy supply, distribution or
use, and has determined that the rule will not have a significant
adverse effect.
J. Plain Writing Act of 2010
Under Public Law 111-274 (October 13, 2010), 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. The Administrator has attempted to
use
[[Page 43523]]
plain language in promulgating this rule consistent with the Federal
Plain Writing Act guidelines.
List of Subjects in 42 CFR Part 88
Administrative practice and procedure, Health care, Lung diseases,
Mental health programs.
Final Rule
For the reasons discussed in the preamble, the Department of Health
and Human Services amends 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-61, Pub. L. 111-347, 124
Stat. 3623, as amended by Pub. L. 114-113, 129 Stat. 2242.
0
2. In Sec. 88.1, under the definition ``List of WTC-related health
conditions,'' revise paragraph (1)(v) and add paragraph (5) to read as
follows:
Sec. 88.1 Definitions.
* * * * *
List of WTC-Related Health Conditions
* * * * *
(1) * * *
(v) WTC-exacerbated and new-onset chronic obstructive pulmonary
disease (COPD).
* * * * *
(5) Acute traumatic injuries:
(i) WTC-related acute traumatic injury: physical damage to the body
caused by and occurring immediately after a one-time exposure to
energy, such as heat, electricity, or impact from a crash or fall,
resulting from a specific event or incident. For a WTC responder or
screening-eligible or certified-eligible survivors who received any
medical treatment for a WTC-related acute traumatic injury on or before
September 11, 2003, such health condition includes:
(A) Eye injury.
(B) Burn.
(C) Head trauma.
(D) Fracture.
(E) Tendon tear.
(F) Complex sprain.
(G) Other similar acute traumatic injuries.
(ii) [Reserved]
Dated: June 27, 2016.
John 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.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2016-15799 Filed 7-1-16; 8:45 am]
BILLING CODE 4163-18-P
