[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]


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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.

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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 [email protected].

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.
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    \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.
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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.
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    \4\ Id.
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    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.
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    \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, http://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_NonCancers_21_Oct_2014.pdf.
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    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).
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    \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.
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    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.
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    \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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[[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.
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    \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, http://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, http://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, http://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.
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    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.
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    \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.
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    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.
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    \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\
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    \18\ 28 CFR 104.21(b).
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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.
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    \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.
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    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\
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    \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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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.
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    \24\ See NIH, National Heart, Lung, and Blood Institute, 
Executive Summary, http://www.nhlbi.nih.gov/research/reports/2011-bronchitis.
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    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\
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    \25\ Christopher Cooper, Assessment of Pulmonary Function in 
COPD, Semin Respir Crit Care Med 2005;26(2):246-52.
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    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.
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    \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.
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    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\
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    \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.
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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.

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            Database                   Search terms           Results
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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).
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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\
---------------------------------------------------------------------------

    \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, http://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, http://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_NonCancer_Conditions_Revision_11_May_2016.pdf.

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[[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.
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    \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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    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, http://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: http://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, http://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, http://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, http://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, http://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, http://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